WO2025049491A1 - Novel sampling and genetic comparison and analysis of cannabis components for commercial differentiation - Google Patents
Novel sampling and genetic comparison and analysis of cannabis components for commercial differentiation Download PDFInfo
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- WO2025049491A1 WO2025049491A1 PCT/US2024/044062 US2024044062W WO2025049491A1 WO 2025049491 A1 WO2025049491 A1 WO 2025049491A1 US 2024044062 W US2024044062 W US 2024044062W WO 2025049491 A1 WO2025049491 A1 WO 2025049491A1
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- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
- H04L9/00—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols
- H04L9/50—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols using hash chains, e.g. blockchains or hash trees
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
- C12Q1/6888—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms
- C12Q1/6895—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for plants, fungi or algae
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/13—Plant traits
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/156—Polymorphic or mutational markers
Definitions
- the present embodiments generally relate to validation of cannabis compositions. Embodiment relate to both the specific acquisition of cannabis materials herein unto difficult to obtain and transport as well as the processing for proper analysis and verification of: chemical composition, genetic makeup and presence of key plant component characteristics, and origin including lineage certification.
- the methods described herein provide quantitation and qualification of chemical compounds of interest via methods of self-contained extraction and sample preparation.
- the methods are facilitated via utilization of a Novel cassette cartridge apparatus.
- the methods also use genetic measurements taken from sample or legacy plant and alleged offspring or clone to determine whether the alleged clone is legitimate as compared to parent.
- the methods also allow for genetic testing and determination of key enzymes and expression of said enzyme involved in the production of chemical compounds of interest. BACKGROUND OF THE INVENTION [003]
- the recreational use of cannabis has been noted for decades. Since the early 1900s, laws and mandates have restricted its usage, possession, and distribution.
- Cannabis strains comprising CBD and other cannabinoids are highly differentiated; consequently, when genetically isolated, strains and resulting byproducts from strains proven to trigger specific biologically relevant receptors.
- Clonership is a process of proving parentage or genetic replication within a scientific (range) of accuracy. This is accomplished by way of an informatics-based method that can compare two or more genetic profiles. Once proven, the product may be certified to carry the brand, thereby honestly signaling the brand’s medicinal value to the market.
- Each of these critical elements will be made possible via the utilization of the innovation of sample collection/processing/analysis described herein.
- Figure 1 depicts ligand/target interactions.
- Figure 2 depicts the bottom half of a cassette.
- Figure 3 depicts the internal shell of the cassette.
- Figure 4 depicts the inner workings and mechanical grinding action of the cassette.
- Figure 5 depicts the front of the cassette.
- Figure 6 provides an assortment of key intermediates as well as the meroterpenoids of interest within a cannabis plant.
- Figure 7 depicts a schematic representation of a genetic comparison and analysis system.
- Figure 8 depicts a schematic representation of a genetic identification and supply chain verification/validation process.
- Figure 9 depicts a schematic representation of a central laboratory system.
- Figure 10 depicts a schematic representation of a satellite laboratory.
- Figure 11 depicts a schematic representation of a public blockchain system.
- Figure 12 depicts a schematic representation of a private blockchain system.
- Figure 13 depicts a schematic representation of Dynamic Non-Fungible Token (dNFT) usage for Identification and Branding
- Figure 14 provides exemplary cannabinoid and dopaminergic receptors.
- dNFT Dynamic Non-Fungible Token
- Figure 15 depicts formulation table for dynamic scoring of affinity, efficacy, selectivity, and enzyme analysis
- Figure 16 depicts an example of the formulation table for dynamic scoring of affinity, efficacy, selectivity, and enzyme analysis 88209.413709
- Figure 17 depicts an example of a receptor’s affinity and efficacy scoring with in the assay engine & resolver module in the CDR System
- Figure 18 depicts an example of a receptor’s enzyme fidelity scoring within the enzyme detection and analysis module in the CDR System
- Figure 19 depicts a dynamic scoring module – scoring example within the CDR system.
- Figure 20 depicts a dynamic scoring module – match criteria central data repository (CDR) system.
- CDR central data repository
- Figure 21 depicts Clonorship Module match criteria with CDR system.
- Figure 22 depicts dNFT and fractional dNFT Workflow.
- Figure 23 depicts CDR blockchain/ERP Workflow. DETAILED DESCRIPTION
- the terms “including” and “comprising” are open-ended terms and should be interpreted to mean “including, but not limited to. . . . " These terms encompass the more restrictive terms “consisting essentially of” and “consisting of.” [040] It must be noted that as used herein and in the appended claims, the singular forms "a”, “an”, and “the” include plural reference unless the context clearly dictates otherwise.
- the embodiments described herein are comprised of three essential parts: the genetic identification of cannabis, non-fungible traceability of identified cannabis throughout the supply chain process, and non-fungible certification of cannabis providing consumers’ verification of its genetic value and authenticity.
- the genetic authentication of cannabis is dependent on several bases. The embodiments depend on testing parameters of cannabis materials, including specific genetic analysis via comparison of genetic measurements.
- the methods 88209.413709 comprise pathways to the material collection as well as material processing.
- meroterpenoids are the specific secondary metabolites produced by cannabis plants.
- meroterpenoids include but are not limited to cannabidiol, cannabidiolic acid, cannabinol, cannabidiolic acid, cannabigerol, cannabinolic acid, cannabielsoin, cannabigerolic acid, cannabidivarin, cannabichromeric acid, trans- ⁇ -8-tetrahydrocannabinol, and/or trans- ⁇ -9- tetrahydrocannabinol.
- Each of these different compounds is present in varying concentrations depending on the strain of the plant.
- concentrations of these compounds are in part predicated on the presence and overall expression of particular cellular processes that dictate the formation and synthesis of said compounds including the presence of specific enzymes.
- the enzymes and expression are contingent on single nucleotide polymorphisms (SNPs). These ratios can be used to identify specific strains of cannabis and help ensure the amount and quality of compounds of interest.
- SNPs single nucleotide polymorphisms
- Non-fungible traceability enables genetic authentication in the supply chain. This creates the potential for increased price elasticity, as the genetic identity and its value potential can be proven. The genetic identity and authentication is documented using blockchain infrastructure, ensuring it cannot be copied, 88209.413709 substituted, or mistaken for another genetic signature.
- Non-fungible certification enables genetic authentication for consumers. Consumers use unique identifiers, i.e., dynamic nun-fungible tokens (dNFT) to access the genetic identity of a product or its comparative ranking against products with similar attributes. They can use computer applications to scan this unique identifier and find all off-chain data attributed to the product.
- dNFT dynamic nun-fungible tokens
- Cannabis source materials can be collected with the sampler kit and will be tested via the process therein.
- the cassette facilitates the screening and analysis of acquired materials via internally contained sample prep that lends to further examination. Extraction and isolation of particular components through the sample prep are streamlined, allowing for rapid access and testing up to and including the previously mentioned. Novel genetic testing parameters and species identification from a procured sample. This is achieved without the need to undergo extensive pre- processing and transport to the testing facility within an enclosed loop, thus 88209.413709 potentially transporting to processing labs with respect to by-laws and guidelines of various municipalities. [047]
- the sample collection and preparation described herein can be used and it will be evident to those skilled in the art that the described methodology can be utilized without explicit details within each step.
- Plant material such as a stem
- the cassette is a self-contained unit composed of high-density polyethylene (HDPE).
- the internal shell is separately encapsulated inside the larger housing unit to ensure security and fidelity of the sample through transport and processing.
- the outer shell is also composed of HDPE with a centralized port that directly links to the cassette's inner core, where the sample can be passed through.
- the double shell approach solves the shortcomings of several currently used storage models for plant materials.
- the internal shell of the cassette ( Figure 4) holds within a mechanical grinder, which is able, with high precision, to macerate samples into a powder/pulp mixture, which since self-encapsulated through double shell design, is incapable of leakage or sample loss after processing.
- the cassette solves a significant problem during sample prep as plant samples are often macerated in external blending or grinding devices, and the precision of transfer of pulverized material to further the process of distillate and isolate formation is within 88209.413709 doubt and question.
- the innovative approach presented by the cassette eliminates this problem, as initial sample processing is self-contained with no transfer points occurring, resulting in the high unlikelihood that the sample will be lost and unable to be further carried on through additional sample prep, extraction, isolation processes, etc.
- the mechanical grinder ( Figure 4) is located, e.g., centrally, within an inner core of the inner shell (3).
- the HDPE construction of the inner shell includes that of a non-stick HDPE inner surface. This further facilitates and ensures the lack of loss from sample processing which is seen and documented in other sample preps, including transfer cases and cassettes of different construction from what is presented here.
- the mechanical grinder can be operated via a manual control unit located on the side of the cassette. Hand operation is able to disrupt the fidelity of sample via the sheer forces of the gears, and more pressure applied and push force applied to the manual apparatus will result in higher sheer forces on the contained sample, allowing sample submitted or end use processor to prepare sample for further processing before or after transport or storage within a self-contained unit.
- the grinding gears will contact with submitted materials in a top-down manner where the grinder (4) will be in direct contact with sample material in the main storage compartment (3) ( Figure 4).
- the HDPE coating 88209.413709 again facilitates smooth processing as a sample, even with the friction created from grinding/maceration of the gears, will not stick, ensuring that all available sample is available for further processing.
- particular reagents including organic solvents, can make available compounds of interest for extraction and analysis without destroying the fidelity of genetic materials that also may be examined within 1-pot of the device.
- the meroterpenoids that are present in highest concentrations as per insinuated by literature are all organic solvent soluble with various levels of lipophilicity.
- reagent port itself allows for the existence of this newly made fluid mash to be stored securely and sealed within the cassette, facilitating transport of a pre-processed sample to a testing facility.
- One aspect is that the pre-processing can now be conducted before sending out samples to where experimentation of extraction methods can occur from core user before sending out for sampling, resulting in potential cost savings on processing for back-end users while avoiding the potential issue of unknown extraction processes that may occur when just a raw sample is sent.
- This feature in the cassette introduces more control and opportunity for a front-end user to sample prepare their own sample to standards agreed upon by the internal user before being sent off to central testing lab.
- Mixtures within the cassette on the back end with testers can then be removed from the cassette via precision syringe in order to assist in analysis (Figure 5).
- the original raw material sample can be simply stored within the container and itself shipped off for processing at a designated testing facility 88209.413709 without the need for sample prep and examination of the target compounds of interest.
- Samples collected can be separately utilized via the presently presented sealed container for particular % presence of compounds of interest.
- 90% ethanol can be injected to the sample cassette for initial extraction of related compounds of interest pull.
- a sulfuric or some other aqueous acidic reagent can be then added into the cassette via the injection port.
- This acid wash facilitates the formation of distillate by facilitating the removal of excipients that are more water soluble than organic in nature as for example, cannabinoid/meroterpenoids prefer organic solvents.
- ethyl acetate can be introduced to create an organic layer cut in which choice materials should gravitate towards. Uncharged, lipophilic molecules derived from plant materials of interest will then be located within this organic layer, with non-wanted material located in aqueous, thus allowing for transport and storage of processed sample to testing facility without worry of contamination via transport. This is significant as the removal of contamination during or on back end of transport before testing as now been significantly mitigated, which to according to current knowledge, is not addressed via other technologies.
- samples can be removed to facilitate the further testing of compound percentage make up from sample.
- di-ethyl ether can also be utilized as extracting solvent for meroterpenoids of interest. These solvent cuts of compound again will be self-contained within the inner shell and removed upon extraction from the cassette at the Central Laboratory for further analytical testing including comparison against noted in-house control samples of meroterpenoids of interest.
- Standardized samples of each of the meroterpenoids of interest will be used to analyze and determine the presence of meroterpenoids within the sample.
- the assay consists of specific and isolated cells for a series of central nervous system relevant receptors, linked to known biology and pharmacology of clinically relevant outcomes. These include but are not limited to the dopamine receptor system, serotonin receptor system and opioid receptor system.
- receptors will be derived from standard practices of cloning into Chinese hamster ovary (CHO) cells, as found in previous literature, and expressed in vitro as CHO as an expression and testing system is well established in practice. Upon expression of particular receptors of interest, compound will be measured for affinity and then efficacy using standardized assays, as found in literature. 88209.413709 Compounds derived will be screened across selected CNS receptors of interest to determine attuned ratios of activity. [061]
- the cassette technology has the capability to simplify not only transport of samples of interest, but also makes sample prep simplified for not only analytical chemistry and subsequent qualitative and quantitative measurement but also in conjunction with facile application to pharmacological assays to determine biological activity both from a potency and selective standpoint.
- the ability to take processed samples straight from the cassette to apply to in vitro pharmacological assays is unique as it is, according to current knowledge, the first use in a manner like this for rapid utilization. This avoids the issue that currently exists with sample preparation for assays as; less than perfect samples gives potentially misleading results including lack of activity or hyperactivity or lack of selectivity of samples.
- the meroterpenoids of interest are secondary metabolites produced from cannabis plants in varying quantities. These are in large part determined by the presence and activity of particular enzymes within the plant that dictate the production of these compounds. These enzymes themselves are coded by proteins, which in turn are determined by particular genes.
- the cassette could serve as a sterile, safe and secure storage or holding unit to either long-term store or ship plant material.
- the cassette can also act as a sample processing unit via its ability to process sample either on-site from the donor of material or at the Central Laboratory once the sample is sent out.
- the disadvantages seen with other known sample preparations lie in the difficulty to pre-process a sample to send off for testing without loss of material or potential exposure to contamination and sample risk.
- the present embodiments offer mitigation around this shortcoming seen with other sample preparations while also providing on the back end, a fully processed sample without loss of valuable material that can occur during transport due to the dual shell design.
- a processed sample that can be contained with the cassette facilitates ease of further genetic testing.
- the cassette serves as a tool for dual sample preparation for plant analysis.
- Samples housed within the syringe will be further processed via exposure to neutralizing agents, followed by an alcohol wash to precipitate out target materials. These steps can/will occur in an adjoining sample preparation kit.
- the sample prep kit itself includes reagents to facilitate analysis on a chemical/biological standpoint. These include various lysing agents for cell wall and membrane breakdown, neutralizing agents to stabilize sample and astringents to foster sample work-up as similarly seen in standard wet-labs.
- the kit will contain select -ases (lysing tools), in 88209.413709 addition to organic alcohol solvent, charcoal based neutralizer and distilled water washes.
- Target material in the alcohol precipitate can be dissolved in water via syringe and injected back into the storage port of the sealed container where it is suitable for storage and/or transport (7). Conversely, the original raw material sample can be simply stored within the container and itself shipped off for processing at designated testing facility without the need for sample preparation. [067] These embodiments allow for mitigation against two current disadvantages. 1. Non-processed samples often are exposed to possible contamination during packaging or transport, which may disrupt accuracy of testing on back end for laboratory facilities. 2. Transport of certain plant materials across jurisdictions is potentially problematic. The cassette presents an enclosed system to help avoid shipping issues as well as a stable system of transporting pre-processed samples that will retain quality for rigorous testing which also helps avoid against any jurisdiction restrictions around work with plant materials.
- the Central Laboratory System contains all Receptor Assays, which act as the control group by which scientific samples are compared. These assays are designed to test scientific sample affinity, selectivity, and efficacy against specific physical receptors Assays as previously described will determine affinity, efficacy and selectivity to particular receptors of interest within the central nervous system, including dopaminergic, serotonergic and opioid receptors in a manner where compounds derived from samples of interest will be challenged against selected particular receptors for ability to bind as well as activate. . The measurement and scoring of each scientific sample establish a Novel numeric value. These values allow for a Dynamic Ranking of all other scientific samples in the Central Laboratory Database associated with a specific receptor.
- Blockchain-based time-stamping process records data within the blockchain system, proving the Scientific 88209.413709 Sample’s existence and performance metrics relative to other scientific samples at a specific time and date (Figure 8).
- the time-stamped, decentralized universe of genetic data and its comparative relativity to specified physical receptors is a Novel market feature.
- the Central Laboratory System is connected to Satellite Laboratories ( Figure 9) by a network of decentralized blockchain nodes within a public blockchain system, comprising the GenoPheno System ( Figure 10).
- Scientific Sample data enters into the Central Laboratory System using the public blockchain interface module; the blockchain node generates a time-stamp, enabling real-time rankings of Scientific Sample receptor performance.
- the Central Laboratory System accepts the Scientific Sample and may compare Scientific Sample to Novel receptor assay datasets within the Central Laboratory’s Assay Engine and Resolver Module. Scientific Samples are scored, compared, then ranked against all other Scientific Samples in the system. [071] A sample’s rankings may change with each officially recorded and calculated ranking updated in the system. Each ranking is able to provide quantitative and qualitative insight into sample submitted as the ranking examines both genotype and phenotype qualities with subsequent available in vitro pharmacology. The first time a sample enters the system it is genetically authenticated, once authenticated it is referred to as a Scientific Sample and is compared to receptor assays, and its potency is determined. Potency being defined as affinity along with efficacy as well as selectivity.
- Scientific samples may have multiple representations including: seeds, plants and by extension plant parts (leaf/stem/pistol/etc.) extract, isolate, various processed representations, commercial or medical consumable products.
- the system is premised on single source of Scientific Sample’s during the genetic authentication process. Users may query Scientific Sample’s based on one or more representations, but these representations stem from a single genetic source.
- Hybrids derived during the genetic verification process may contain more than one source of Scientific Sample’s, but genetic authentication, enzyme analysis, and receptor affinity, selectivity, and efficacy is derived from a single source of Scientific Sample’s. Verified products are labeled with a unique identifier, i.e.
- dNFT dynamic non-fungible token using the ERC 1155 standard
- Dynamic scoring and ranking create a live view of the market for consumers. A consumer seeking a strain of cannabis intending to stimulate analgesic receptors will use this system to find the highest-ranking strain. Furthermore, the system allows the consumer to determine the highest-ranking strain with multi-receptor activity, enabling a new level of qualitative and quantitative consumer analysis.
- Dynamic scoring and ranking of a strains ability to stimulate particular receptors as well as for affinity, efficacy and selectivity at a particular receptor enables qualitative and quantitative valuation. When two or more strains are comparatively ranked by features, the consumer perceives benefit and makes rational selections. Perceived benefits also enable the ranking between strains and external products (i.e., Pharmaceuticals) with similar beneficial properties.
- Dynamic scoring and ranking create a live view of the pricing for manufacturers. Dynamic scoring and ranking will drive consumer sentiment, when captured this activity will drive the decision making of manufactures; and selecting strains for products will be driven by consumer sentiment.
- Ranking consists of the following critical elements. 1st, fit with receptor of interest hereunto known as receptor affinity.
- Receptor affinity will be based off isolated compounds of interest associated with attributes or possible claims of value-add biologically active agent’s capability to bind to a particular receptor.
- These receptors include but are not limited to central nervous system associated systems including cannabinoid and dopaminergic receptors as well as opioids ( Figure 11).
- 2 nd activity at said receptor hereunto known as receptor efficacy.
- Efficacy will be measured by determining ability of isolated compounds of interest associated with attributes or possible attributes of value-add biologically active agent’s capability to not only bind but also activate receptors of choice as measured by particular assays of choice. Full agonists, partial agonists, reverse agonists and antagonists will be determined.
- [079] 3 rd expression efficiency of key enzymes responsible for production of isolated compounds of interest.
- Compounds of interest such as, meroterpenoids from cannabis plants, are biosynthesized by complex chemical pathways dictated by particular enzymes that are themselves coded for by particular genes. The % expression of these genes determine the amount and efficiency of enzymes 88209.413709 produced isolated compounds of interest. This feature is captured within the ranking system as attributes to consistency of quantity with a particular compound.
- selectivity of the receptors over other targets will also be incorporated in, determining an overall score of the compound in question according to the Scientific Sample scale. Selectivity will include the ability to bind to and stimulate a receptor at a higher ratio and percentage than others.
- Scoring will entail weighted averages of receptor affinity, contrasted with efficacy or lack thereof at receptors, and factored against production of gene. Scoring will have the following equation: [081] Receptor Affinity (in where affinity ⁇ 100 nM will be scored on a sliding scale in where low numbers would result in higher “score.” An example would be ⁇ 1nM would correspond to a score of 10 while > 200 nM would score as a 1. [082] Receptor efficacy where efficacy will be measured with standard assays and scoring will be based on impact levels ranging from nM to pM with a weighted score given to more “potent” analogs.
- Scoring will be on a highest score in which a 100 point scale in which 100 equals the highest levels of rank activity, selectivity efficacy and enzyme activity which directly translates into enzyme production. This score will then be given alongside the quality of a sample against biological target, such as pain/sleep/anxiety.
- binding and efficacy concentration will be determined on a sliding scale based of nM concentrations such as follows ( Figure 12).
- Ranking will be determined based off scores from assay results as well as perceived metric of pharmacological value based for WHO quality of life calculations and overall impact of QALYs also known as quality adjusted life year.
- the Central Laboratory and Satellite Laboratories provide the intake for samples and ultimately document a subject’s genetic value, where value is established as a strain producing relevant biologically active components that can be attributed to claims of utility, purpose, and value. Furthermore, the Central Laboratory and Satellite Laboratories will establish a dynamic system to certify authenticity at various points throughout the supply chain, facilitate payment and purchase, and facilitate the scoring and dynamic ranking of genetic profiles, while the blockchain system serves as the bridge between both systems time-stamping a subject’s existence in a decentralized constellation of independent laboratories. [090] Clonership [091] The system employs the Clonership method to facilitate the application and restriction of naming configurations for genetic profiles.
- the system enables genetic profile owners to register a brand, defined as a word, words, phrase, or design, or a combination that identifies a genetic profile, 88209.413709 distinguishing it from other genetic profiles. Once a genetic profile is registered within the system, and a brand assigned, genetic fidelity is defined by a 92% genetic match ⁇ 3% is required to use an assigned brand. Genetic profiles that fall outside of a 92% genetic match ⁇ 3% shall not use an assigned brand.
- Clonership s blockchain-based time-stamping process, records data at the Central Laboratory or Satellite Laboratories, proving the sample’s existence and branding at a specific time and date, facilitating a first-to-file system for branding configurations, and establishing verification thresholds for comparative analysis and certification of its branding authenticity.
- Figure 21 For example, Acapulco Gold is a well-known cannabis brand. The universe of products usurping the brand’s consumer recognition is broad, and its genetic footprint is vast. Acapulco gold products may share little genetic resemblance. Clonership identifies genetic parentage and creates a Novel range within the accepted confidence level. The time and date provide a first-to-file advantage within the system, documenting ownership, branding, and market relativity.
- SNPs Single nucleotide polymorphisms
- SNPs can occur all along the genetic sequence within organisms including plants. These SNPs may lend to unique characteristics within plants including cannabis. At this juncture, to the best of the inventors’ knowledge, SNPs are not being utilized to classify “parent” strains of cannabis nor are rapid sample preps facilitating the ability to test for SNPs amongst cannabis samples.
- the present sample preparation in addition to lending itself for the extraction of compounds of interest is able to step further by also allowing the processing of genetic material to exploit and examine the actual SNPs that may be present resulting in differentiation of parent versus clone strains of cannabis plants.
- bioinformatics will facilitate the analysis of quantification of differences between specific gene variations and will be facilitated by standardized statistical analysis where submitted parent/clone or hybrid materials will have measurements conducted from as submitted sample (DNA and/or otherwise) and using informatics approach, specific information will be captured. This stems from the ability to examine the individual alleles from genetics found in the 20 different chromosomes within the cannabis plant.
- Hybrid strains will be clearly identified as such, as they will have similar yet distinct genes of interest and SNPs from parent material. This is in part due to the nature of hybrid strains having at least one other set of genetic origin material present within submitted samples. Comparative analysis via informatics to an existing database will demonstrate that hybrid strains will be no greater than a 95% match according to lower and upper threshold limits. Additionally, genes within hybrid strains themselves can be matched with good confidence to the original contributor strains when analytics falls between lower and upper thresholds. [098] Genomic measurement is facilitated by the sample preparations described herein. Upon sample preparation, various techniques to establish genetic origin can be utilized. These include the use of polymerase chain reaction to amplify genetic material and subsequent analysis of genetic material using the current state of technology and tools.
- SNP genotyping and microarrays will be SNP genotyping and microarrays, along with standard Sanger style sequencing.
- Other tools utilized to identify specific genes of interest will be fluorescent in situ hybridization, high throughout genotyping and comparative genomic hybridization to examine ploidy between samples submitted which will assist in the measurement of parent/clone and determination of such vs 88209.413709 hybrid strain samples.
- Other genetic testing paradigms can be included and used as stand-alone or in combination to map out genetics of submitted sample materials for comparison. These assays are all amenable based on the rapid sample and preparation and processing described herein which differentiates from known standard protocol preparation, which typically require laboratory infrastructure to facilitate.
- Enzymes of Interest Examination In addition to examination of cannabis alleles across the entire sequence of plants, the sample preparation will also facilitate specific examination of key genetic characteristics. In particular, enzymes themselves involved with meroterpenoid synthesis. Type III polyketide synthase (PKS), olivetolic acid cyclase (OCAC), THC-A synthase (THCA-syn) and CBD-A synthase (CBDA-syn) are the key enzymes involved in the production of the key intermediates as well as the meroterpenoids of interest within the cannabis plant.
- PPS polyketide synthase
- OCAC olivetolic acid cyclase
- THCA-syn THC-A synthase
- CBD-A synthase CBD-A synthase
- THCA-syn polymorphism can lead to the production and variation of the amount of psychoactive materials produced in cannabis plants.
- the method described herein facilitates testing for the present of the level of expression of particular enzymes as well as for any polymorphisms.
- Polymorphisms in THCA- syn for example can heavily influence and dictate the amount of psychoactive components within a cannabis plant and identification of polymorphisms provide end users with an accurate approximation of how much several particular meroterpenoids per weight basis will be present within the plant.
- polymorphisms within key enzymes such as THCA- syn can also be used as a “fingerprinting” technique to determine strain of various cannabis plants as well as origin, i.e. male/female/parent/clone. 88209.413709
- THCA- syn a “fingerprinting” technique to determine strain of various cannabis plants as well as origin, i.e. male/female/parent/clone. 88209.413709
- the present cassette device in addition to the sample preparation that follows, facilitates ease of sample process and testing for particular elements involving enzymes, stemming from the SNPs that dictate these.
- SNPs single nucleotide polymorphisms
- SNPs within the genetic sequence of enzymes provide more detailed identification of cannabis strains and associated enzymes that produce secondary metabolites of interest, such as the meroterpenoids.
- the advantage lies in the fact that a SNP with the enzyme may alter the fidelity and function of key enzymes, however, the SNPs may also be silent in terms of activity but still differentiate strains, further helping to isolate patentable strains from the existing genetic diversity that exists within cannabis strains.
- SNPs are not being utilized to defend patent position and the current methodology will facilitate differentiation of strains via presence of specific enzyme (aforementioned) expression as well as particular SNPs of interest within each of these enzymes, thus allowing a higher and more precise level of identification of unique strains and enzymatic features of interest for cannabis plants.
- Identification of SNPs that code for the enzymes that in turn determine the level of meroterpenoids within a sample is advantageous as introduced a level of consistency that is currently not seen within cannabis production.
- the ability to specifically know how much and which meroterpenoid will be present within a sample will, according to current knowledge, for the 1 st time, allow producers to definitely make claims specific to their strain of cannabis.
- THCA-syn enzymes and associated polymorphisms of which 16 are of note, will be examined but not alone, examination via the sample preparation will allow for determination of CBDA-syn as well including potential polymorphisms identified as standard which in this case refer to high THC-A synthase expressing strains.
- SNPs can occur within strains of cannabis alone, or numerous SNPs at key positions on the alleles can occur, each of which can be captured and identified to establish identity of strains. Again, the utilization of SNPs to establish identity of cannabis strain via the enzymes that produce secondary metabolites is not appreciated within the field and will be facilitated via the present embodiments of sample preparation and testing.
- Non-fungibility is a basis for the embodiments described herein; records certifying genetic confirmation and supply chain validation as true and accurate. Recorded in blockchain, they are certified authentic, and cannot be copied, substituted, subdivided, or assigned to another genetic signature.
- Blocks of data are controlled and confirmed by a decentralized ledger system managed by multiple public blockchain nodes and a network.
- the system s public blockchain nodes operate at each satellite 88209.413709 laboratory and the Central Laboratory. All laboratories issue blocks of data representing digital assets identified by a smart contract on the blockchain.
- dNFT Dynamic Non-Fungible Tokens
- the Central Laboratory After establishing an account, the Central Laboratory issues a scientific sample cassette or cassettes to the sample owner. Initially, cassettes are identified by QR CODE. Associated metadata, at a minimum, should include unique IDs assigned to identify the account holder and the sample lot.
- the cassette is sent to the account holder; once received, the sample is inserted into the cassette and sent to a satellite laboratory for general screening that may include: residual solvents, pesticides, potency, terpenes, heavy metals, mycotoxin, moisture, water activity, pathogenic microbiology, PAH, qPCR, and filth and foreign materials.
- a satellite laboratory for general screening that may include: residual solvents, pesticides, potency, terpenes, heavy metals, mycotoxin, moisture, water activity, pathogenic microbiology, PAH, qPCR, and filth and foreign materials.
- This Novel approach enables third-party genetic verification without broadcasting an entire database of genetic profiles and can be used to verify any volume of homogenous genetic material (Figure 8). If the sample is suspected to be a Novel genetic profile, the sample is sent to the Central Laboratory for genetic profile analysis. [0113] Once established in the Central Database, future samples will be identified by a Dynamic Non-fungible Token. The sample’s account holder may verify genetic material to an existing genetic profile at a satellite laboratory. The targeted genetic profile is contained within the sample’s unique identifier, a dNFT (dynamic non-fungible token using the ERC 1155 standard and containing a QR code).
- dNFT dynamic non-fungible token using the ERC 1155 standard and containing a QR code
- the QR code within the dNFT holds a maximum of 7089 numeric characters, 4296 alphanumeric characters, or 2953 alphanumeric characters with spaces and 88209.413709 punctuation is the physical limit of a QR code, as defined by ISO/IEC 23941:2022 standards. These characters are used to scientifically describe the genetic profile control material rather than requiring physical control material to test.
- Figure 13 Genetic profile in this regard refers to enzymatic production and the presence of key compound-producing enzymes ( Figure 7). In particular, this is THC-A Synthase, the key enzyme, and reactor to produce base compounds found within the cannabis plant into THC/THC-related compounds.
- Efficacy and receptor activation are critical to biological activity as activation of a receptor and subsequent signaling leads to the observable biological and pharmacological phenomenon observed. Efficacy as a differentiator will show which strains produce and have compounds that can be associated with an observed biological outcome. [0117] Another measurable attribute pertains to selectivity. Selectivity in this context refers to the isolated and extracted compounds from plant samples and how selective they are with respect to which receptors these compounds display affinity and/or efficacy to. Selectivity also differentiates samples by demonstrating that compounds produced by samples are more or less promiscuous in terms of pharmacological activity. This is key as selective compounds can differentiate and discern which samples trigger response biologically, translating to an attribute of the sample source material (Figure 15).
- Each concept can be associated with multiple representations, including schematics of overlays from the genetic makeup of each plant strain sample as it relates to the physical-chemical products produced, including rations and how these may or may not stimulate 88209.413709 pharmacologically relevant receptors and the likelihood that this stimulation leads to statistically significant or documented clinically significant response.
- the satellite laboratory verifies a sample matching within the accepted confidence level an existing genetic profile scientifically described within the dNFT, then the sample is confirmed certified within the blockchain system, and may be sold or contained in other products while baring the certified brand, and marketing its genetic features (Figure 23).
- De novo, genetic profile analysis is completed at the Central Laboratory. Upon arrival, the sample’s identifying label is scanned.
- the sample is then tested for genetic identification, as defined in the genetic identification section. If the sample is once again confirmed de novo, Clonership, receptor scoring & ranking, and enzyme detection may continue ( Figure 19). [0122] If the sample is de novo, then the sample account holder may brand the genetic profile, as described in the Clonership process. [0123] If the sample matches within the accepted confidence level an existing genetic profile contained within the Central Laboratory System, the sample owner may license the branding reserved within the Clonership process. The sample owner may not establish a new brand within the established confidence level for an existing genetic profile. [0124] If the sample does not match an existing genetic profile, the genetic profile is considered de novo, and the Clonership process, receptor scoring, and enzyme detection may occur. These data comprise the scientific sample’s genetic profile.
- Data may be queried by one or more physical receptors or possibly by products ranked by receptor stimulation or receptor stimulation potency, including but not limited to affinity, selectivity, and efficacy at said pharmacological receptors; by geographic location, manufacturer, brand, or retail establishment. They also may be queried by specific item or lab result (Figure 15) with the location of strain associated back to genetic variability historically associated with indigenous plant samples of the region.
- the system issues the parentage owner a unique identifier (i.e., Dynamic Non-fungible Token (dNFT) assigned to the genetic parentage. Consumers may use computer applications to scan this unique identifier and find on-chain and off- chain data attributed to the product ( Figure 23).
- dNFT Dynamic Non-fungible Token
- the cassette device provides the ability to process a sample rapidly for in vitro pharmacological testing of a unique suite of receptors that are considered to then link to show desired biological effects.
- the cassette provides the milieu to conduct such testing at each level via its innovative design and sample preparation.
- a self-contained sample capture and processing unit for the collection and transportation of genetic material comprising: a self-contained sample capture and processing unit that allows for the extraction and isolation of compounds of interest within cannabis plants used to establish genetic parentage, wherein a.
- the method for capture and/or processing allows for ease of transport without the disruption of regulatory statues as non- regulated material from the cannabis plant is extracted (the stems); and, b.
- a method of measuring, scoring or ranking receptor stimulation by cannabis or hemp strains by employing genetic diagnostic testing on a seed or a plant sample, wherein a.
- a genetic diagnostic test resulting in the establishment of a genetic control with a test requiring a minimum of (30 samples), with results indicating a confidence level of ( ⁇ 95%) of the genome map and identification of genetic markers indicating stimulation of one or more physical receptors, as well as particular SNPs of interest for metabolizing enzymes germane to the production of compounds of interest; in which the scoring system works in sections of an algorithm, wherein the algorithm components comprise: selectivity of compounds produced and extracted from plant at biological receptors of interest.
- Efficacy at biological receptors, Levels of affinity at biological receptors and qualitative production of enzymes responsible for the synthesis of compounds of interest in plant based off genetic identification wherein b. Precision diagnostic tests resulting in the scoring of the potency of the physical receptor stimulation at the cannabis or hemp seed or cultivation; and/or c. Genetic traceability, diagnostic test or tests to confirm the genetic identification throughout the supply chain post cultivation, 88209.413709 wherein confirming the genetic identity within extraction, processing, and/or manufacturing; d. Genetic parentage, uniquely identified by Dynamic Non-fungible Token (dNFT); and e. Laboratory results are time-stamped and secured by blockchain, and/or centrally archived.
- dNFT Dynamic Non-fungible Token
- a computer-implemented method for grouping genetic diagnostic results from one or more laboratory systems wherein satellite laboratory data is transferred and centrally processed and stored, wherein the transfer of the genetic diagnostic results is secured and time-stamped using blockchain, wherein a centralized data repository verifies a blockchain contract transactions, then translates, normalizes, scores, and/or ranks, genetic diagnostic results before storing the data in a centralized data repository, wherein the method includes a.
- a genetic diagnostic test confirming the genetic match between (30 samples), with results indicating a confidence level of ( ⁇ 95%); and/or
- Genetic diagnostic test resulting in the scoring of the potency of the physical receptor stimulation of the cannabis or hemp seed or cultivation.
- Genetic diagnostic test resulting in the selectivity of physically stimulated receptors of the cannabis or hemp seed cultivation; and, d. Laboratory results are time-stamped and secured by blockchain, and/or centrally archived.
- Laboratory results are time-stamped and secured by blockchain, and/or centrally archived.
- One or more genetic diagnostic tests indicating a confidence level of ( ⁇ 95%) of the genome map and identification of genetic markers indicating stimulation of one or more physical receptors indicating Clonership; and/or b.
- a self-contained sample capture and processing unit identified by a Dynamic Non fungible Token (dNFT) containing on-chain and off-chain reference information that are time-stamped, secured by blockchain, and centrally archived, and attached to a self-contained sample capture, processed cannabis or hemp, or commercial product.
- dNFT Dynamic Non fungible Token
- a. Contains on-chain data identifying genetic parentage name, time- stamp within the system, parentage ownership, reference numbers; and, b. Contains on-chain data identifying the genetic parentage profile, containing on-chain data that including Clonership identification via informatic approach of genetic materials; and, 88209.413709 c.
- a system comprising satellite laboratories having directed genetic diagnostic results to a centralized data repository using a blockchain-based decentralized satellite system portal by executing blockchain contracts, genetic diagnostic results shall associate and be mapped to at least one receptor assay data set in the centralized data repository’s assay engine & resolver module, the centralized data repository having the genetic diagnostic results associated with at least one receptor or more data sets used to map the genetic diagnostic results, a method for managing at least one receptor assay in the centralized data repository, the method comprising: a. an act of receiving a genetic diagnostic results from the satellite laboratory workstation via the decentralized satellite system portal, wherein the result is associated with blockchain contract interface code provided by the centralized data repository; and/or, b.
- a method for modifying the content of a centralized data repository by a decentralized satellite system comprising: a. A step for determining a current representation of current physical location of data stored in the centralized data repository; and/or, b. an act of altering the decentralized satellite system’s current data representation without altering the physical receptor data in the centralized data repository; and/or, 88209.413709 c. A step for receiving input from the decentralized satellite system that identifies a new representation for the current physical location data; and/or, d.
- a method for accessing verified results of a centralized data repository by remote users comprising: a. A step for accessing a current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and or hemp strains by the receptors; and/or, b.
- Representations are limited to one source of genetic diagnostic results; and, e. Genetic diagnostic results is limited to one genetic source.
- 88209.413709 A method of using a centralized data repository to map genetic diagnostic results, in addition to other pertinent in vitro pharmacological results including but not limited to composition of matter and target of activity, i.e. physical receptor, received from a decentralized satellite system for storage in a centralized data repository, a method for mapping representations of the laboratory data genetic diagnostic results to the centralized data repository, the representations provided by the decentralized satellite system, the method comprising: a.
- a step for receiving a current representation identified by the decentralized satellite system and/or, b. a step for searching the centralized data repository for the current representation; and, c. a step for searching the centralized data repository for the current ranking and scoring of genetic diagnostic results; and, d. a step for searching the centralized data repository receptors stimulation potency, including but not limited to affinity, selectivity and efficacy at tested receptors; and, e. a step for searching centralized data repository of enzymes and isoforms of enzymes of interest; and, f. a step for receiving instructions from decentralized satellite system; and, g. a step for managing the current representation in accordance with the receive; and, h. instructions such that the current representation is mapped to the centralized data repository.
- a method of creating fractional dNFTs to track and manage more than one owner of a genetic profile a. A step for submitting parentage ownership proof; and, 88209.413709 b. A step for creating and deploying the smart contract; and, c. A step for assigning fractional ownership by shares; and, d. A step for entering the contract address; and, e. A step for entering the image; and, f. A step for entering metadata identifying genetic parentage name, time-stamp within the system, parentage fractional ownership, reference numbers; and, g. A step for entering metadata identifying genetic parentage name, time-stamp within the system, parentage ownership, ownership status, reference numbers; and, h.
- a step for entering metadata referencing dynamic comparative data comprising other parentage profiles and genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; Contains off-chain data referencing dynamic comparative data comprising ratio of compounds presence compared to known 88209.413709 reference samples as well as selectivity of receptors stimulated; and, m.
- a step for entering metadata referencing location restrictions; and, p. A step for entering metadata referencing various regulatory approvals and clinical data; and, q.
- a method of creating dNFTs to track and manage one owner of a genetic profile a.
- a step for deploying the smart contract; and b. A step for entering the contract address; and c.
- a step for entering the image; and, d. A step for entering metadata identifying genetic parentage name, time-stamp within the system, divided parentage ownership, reference numbers; and, 88209.413709 e.
- a step for entering metadata referencing dynamic comparative data comprising other parentage profiles and genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; Contains off-chain data referencing dynamic comparative data comprising ratio of compounds presence compared to known reference samples as well as selectivity of receptors stimulated; and, k.
- a step for entering metadata referencing location restrictions; and, n. A step for entering metadata referencing various regulatory approvals and clinical data; and, o.
- a system comprising a laboratory, central data repository, and dNFTs immutably linked to a specific genetic parentage to track and manage the verification, purchase, and payment for hemp and cannabis within a supply chain, as well as tracking payments to licensees to licensors, and payments to government authority.
- a. A step for a laboratory accepting a shipment of cannabis or hemp into an inventory management system by scanning an attached dNFT; and, b.
- a step for verifying a sample matches a requested genetic parentage within the dNFT; a, e.
- the present invention provides 1.
- An apparatus for the collection and transportation of genetic material comprising: a self-contained sample capture and processing unit for the extraction and isolation of compounds of interest within cannabis plants, wherein the self-contained sample capture apparatus provides for a.
- a cannabis plant source from a cannabis source within the self-contained sample capture apparatus suitable for transportation of genetic material; b. qualification and quantification of chemical compounds of interest (meroterpenoids) identified from the cannabis plant source within the self-contained sample capture apparatus; c. a receptor screening assay is performed with clinical data read- outs from the cannabis plant source within the self-contained sample capture apparatus, wherein cannabis source is extracted to provide the cannabis plant source; and d. the extracted cannabis plant source is identified by QR Code, or Dynamic Non-fungible Token (dNFT) including selectivity, affinity and/or efficacy at receptors of interest.
- dNFT Dynamic Non-fungible Token
- a self-contained sample capture and processing unit that provides extraction and isolation of specific genetic testing for key genetic 88209.413709 markers within cannabis plant material including entire genome mapping, wherein the self-contained sample capture and processing unit provides: a. key enzymes of genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including identification of isoforms of enzymes of interest; b. clonership identification via an informatic approach of genetic materials including the identification of parent, clone and/or hybrid strain of samples that are identified by QR Code, or Dynamic Non-fungible Token (dNFT); and c. archiving laboratory results that are time-stamped and secured by blockchain, and centrally archived, wherein the cannabis plant material is extracted within the self-contained sample capture unit.
- key enzymes of genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including identification of isoforms of enzymes of interest
- b. clonership identification via an informatic approach of genetic materials including the identification of parent, clo
- a method of measuring, scoring and/or ranking receptor stimulation by cannabis or hemp strains by employing genetic diagnostic testing on a seed or a plant sample provided by: a. a genetic diagnostic test resulting in the establishment of a genetic control with a test requiring a minimum of 30 samples, with results indicating a confidence level of ( ⁇ 95%) of the genome map and/or identification of genetic markers indicating stimulation of one or more physical receptors, as well as particular SNPs of interest for metabolizing enzymes in which the scoring system works in sections of an algorithm, wherein the algorithm components are: selectivity of compounds produced and extracted from a plant sample with biological receptors based on genetic identification; 88209.413709 b.
- a computer-implemented method for grouping genetic diagnostic results from one or more laboratory systems wherein satellite laboratory data is transferred and centrally processed and stored, wherein the transfer of genetic diagnostic results is secured and time-stamped using blockchain technology, wherein a centralized data repository verifies blockchain contract transactions, then translates, normalizes, scores, and/or ranks, genetic diagnostic results before storing the data in a centralized data repository, wherein a. a genetic diagnostic test confirms the genetic match between 30 samples, with results indicating a confidence level of ( ⁇ 95%) and b. genetic diagnostic testing resulting in the scoring of the potency of the physical receptor stimulation of the cannabis or hemp seed or cultivation.
- a genetic diagnostic test resulting in the measurement of the potency of the physical receptor including one or more of affinity, selectivity and/or efficacy at a particular receptor; and/or 88209.413709 c. a method of ranking of the potency of the physical receptor stimulation against one or more genetic strains stimulating the same receptor; and/or d. a method of ranking of the potency of the physical receptor stimulation against one or more genetic strains stimulating the same receptor in addition to a comparison of stimulation levels for each receptor.
- Satellite Laboratories sending genetic diagnostic results to a centralized data repository using a blockchain-based decentralized satellite system portal, wherein executing blockchain contracts or genetic diagnostic results are mapped to at least one receptor assay data set in the centralized data repository’s assay engine and/or a resolver module, the centralized data repository having the genetic diagnostic results associated with at least one receptor or more data sets used to map the genetic diagnostic results, the method comprising: a. receiving a genetic diagnostic result from the satellite laboratory workstation via the decentralized satellite system portal, wherein the result is associated with a blockchain contract interface code provided by the centralized data repository; and/or b. searching blockchain contracts within the centralized data repository for the assay results, wherein the genetic diagnostic results are compared to one or more assay results associated with one or more physical receptors.
- a method for modifying the content of a centralized data repository by a decentralized satellite system comprising: a. determining a current representation of current physical location data stored in the centralized data repository; 88209.413709 b. altering the decentralized satellite system’s current data representation without altering the physical receptor data in the centralized data repository; c. receiving input from the decentralized satellite system that identifies a new representation for the current physical location data; d. modifying the current representation to the new representation without affecting a receptor identifier associated with the current representation; and e. storing the new representation to the centralized data repository.
- a method for accessing verified results of a centralized data repository by remote users comprising: a.
- a current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and/or hemp strains by receptors accessing a current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and/or hemp strains by receptors; b. accessing the current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and/or hemp strains by the receptors stimulation potency, including but not limited to affinity, selectivity and/or efficacy at tested receptors; and c. accessing the current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and/or hemp strains by the receptors stimulation potency ranking, wherein representations are limited to one source of genetic diagnostic results; and/or genetic diagnostic results are limited to one genetic source.
- a system including a centralized data repository for mapping genetic diagnostic results in addition to in vitro pharmacological results including composition of matter and target of activity, received from a decentralized satellite system for storage in a centralized data repository, resulting in a method for mapping representations of laboratory data genetic diagnostic results to the centralized data repository, wherein the method comprises: a. receiving a current representation identified by the decentralized satellite system; b. searching the centralized data repository for the current representation; c. searching the centralized data repository for the current ranking and scoring of genetic diagnostic results; d. searching the centralized data repository receptors stimulation potency, including but not limited to affinity, selectivity and efficacy at tested receptors ; e.
- a method of creating fractional dNFTs dynamic Non-Fungible Token) to track and manage more than one owner of a genetic profile comprising a. submitting parentage ownership proof; b. creating and deploying a smart contract; c. assigning fractional ownership by shares; d. entering the smart contract address; 88209.413709 e. entering an image of a QR code of a dNFT; f.
- a method of creating Dynamic Non-Fungible Tokens (dNFTs) to track and manage one owner of a genetic profile comprising a.
- deploying a smart contract b. entering the smart contract address; c. entering an image of a QR code of a dNFT; d. entering metadata identifying genetic parentage name, time-stamp within the system, divided parentage ownership, and/or reference numbers; e. entering metadata identifying genetic parentage name, time-stamp within the system, parentage ownership, ownership status, and/or reference numbers; 88209.413709 f. entering metadata identifying the genetic parentage profile, containing on-chain data that includes Clonership identification via an informatic approach of genetic materials; g. entering metadata identifying key enzymes and genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including that of any and all isoforms of enzymes of interest; h.
- a system comprising a laboratory, central data repository, and Dynamic Non-Fungible Tokens (dNFTs) linked to a specific genetic parentage to track and manage verification, purchase, and/or payment for hemp and/or cannabis within a supply chain, as well as tracking payments from licensees to licensors, and/or payments to a government authority, the system including a. accepting a shipment of cannabis or hemp into an inventory management system by scanning an attached dNFT; b. testing a sample of the shipment to verify it matches the purported parentage within the dNFT; c. accepting payment for a shipment; d. verifying a sample matches a requested genetic parentage within the dNFT; e.
- dNFTs Dynamic Non-Fungible Tokens
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Abstract
Described herein is a method for sample creation and processing of cannabis plant products and source materials for the purpose of in depth analysis. The method facilitates the isolation and enclosed extraction of chemical compounds of interest from the plant for both qualification and quantification. Furthermore, the method described herein, due to its ability to release genetic material, allows for the examination and analysis of specific key genes for enzymes involved with the production of chemical compounds of interest within the plant. Lastly, the method described herein allows for complete analysis of plant genomes due to the processing of the plant releasing genetic material for analysis. The method to conduct analysis enables testing via specific sample prep release of materials of interest as well as circumventing regulated materials restrictions within a self-contained unit that readies sample for further analysis is a basis of the process.
Description
88209.413709 NOVEL SAMPLING AND GENETIC COMPARISON AND ANALYSIS OF CANNABIS COMPONENTS FOR COMMERCIAL DIFFERENTIATION CROSS REFERENCE TO RELATED APPLICATIONS [001] This application claims priority to U.S. Patent Application Serial No. 63/579334, filed August 29, 2023, the entire content of which is incorporated herein by reference. FIELD OF THE INVENTION [002] The present embodiments generally relate to validation of cannabis compositions. Embodiment relate to both the specific acquisition of cannabis materials herein unto difficult to obtain and transport as well as the processing for proper analysis and verification of: chemical composition, genetic makeup and presence of key plant component characteristics, and origin including lineage certification. The methods described herein provide quantitation and qualification of chemical compounds of interest via methods of self-contained extraction and sample preparation. The methods are facilitated via utilization of a Novel cassette cartridge apparatus. The methods also use genetic measurements taken from sample or legacy plant and alleged offspring or clone to determine whether the alleged clone is legitimate as compared to parent. The methods also allow for genetic testing and determination of key enzymes and expression of said enzyme involved in the production of chemical compounds of interest. BACKGROUND OF THE INVENTION [003] The recreational use of cannabis has been noted for decades. Since the early 1900s, laws and mandates have restricted its usage, possession, and distribution. Despite these restrictions and regulations, the use of cannabis for recreational purposes continues to increase despite the legal and social stigmas attached to its usage, with abatement becoming more negligible in many municipalities and
88209.413709 various jurisdictions. Additionally, as more discoveries around the significant components and constituents within cannabis plants, utilization has become more widespread for recreational and non-recreational purposes. These include utilizing cannabis or reported “extracts” for pain alleviation, mood disorders, and sleep. Coincidently, this also correlates with loosening restrictions within specific jurisdictions and growing social acceptance. [004] The ability to ensure quality and consistency within product compositions and the origin of matter would inject much-needed transparency into the cannabis trade and benefit consumers and purveyors alike. Scientifically validated testing methods for particular traits would satisfy the unmet need and bring much-needed legitimacy into the rapidly growing cannabis and cannabis-based goods business. [005] Multiple strains of cannabis are often combined when extracted, with little thought given to the genetic cocktail created. The result is a mixture of active and inactive components and cannabinoids such as cannabidiol (CBD), tetrahydrocannabinol carboxylic acid (THC-COOH), and several other meroterpenoids of interest. Meroterpenoids are the main chemical structural class of molecules present in cannabis. Cannabis strains comprising CBD and other cannabinoids are highly differentiated; consequently, when genetically isolated, strains and resulting byproducts from strains proven to trigger specific biologically relevant receptors. These receptors have specific medical values with clinical significance (i.e., sleep, anxiety, and pain). These isolated genetic profiles can be scientifically and clinically proven to provide specific medicinal value through providing active components in particular ratios. However, when multiple strains are processed collectively, medicinal value can no longer be predicted as compounds of value within the plant vary in concentration. Additionally, combining multiple strains for processing creates difficulty in isolating compounds of interest to test and verify pharmacological function rigorously and consistently. [006] Furthermore, as witnessed in the cannabis black market, superior genetic profiles became known for performance. Cultivators branded genetic strains for
88209.413709 commercial recognition, but federal trademarks could not protect them. Consequently, imposters usurped the brands, and cultivators lost the ability to demonstrate genetic fidelity to a particular strain, limiting the consistent presence of key components of value within the plant/claimed strain. As cultivators could not prove genetic purity via brand promise, the economic value potential of the genetic strain is diminished if not lost. This is further compounded by the difficulties and inability to accurately state the amount/concentration of compounds with value within the plant material. [007] Brand establishment is critical, as cottage industries have popped up, looking to capitalize on the aforementioned points of the medicinal value of cannabis by providing cannabis and cannabis-based products in sanctioned dispensaries or through various other brick or non-brick and more outlets. There is little to no oversight or regulation by any governing body, including the FDA, to verify the purity of sold products or the validity of the medical claims. Manufacturers are not making fact-based claims. Nor are they providing documented evidence that compounds of interest are present within their products or how these compounds interact within the body from a target ligand interaction perspective, metabolic perspective, or, more importantly, toxicology perspective as related to ligand/target interaction. (Figure 1). [008] Additionally, there is no sanctioned authority to confirm the origin of materials or the differentiation of strains. A parent and/or clone of the three main strains for medicinal and recreational use: ruderalis, sativa, and indica with numerous “hybrid” strains. The inability to accurately assess the type of cannabis utilized within various goods is a significant hurdle to the consistency of quality and product profile. As more and more local municipalities begin to allow the “infusion” of consumable food products and beverages with THC, it will be critical to establish proper checks and balances for the quality and quantity of THC within these assets. However, despite the clear need, testing is further compounded by
88209.413709 restrictions on transporting cannabis materials across jurisdictions, making testing impractical for many. [009] The ability to ensure quality and consistency within product composition and origin of matter would inject transparency into the cannabis trade, a benefit for consumers and purveyors alike. Scientifically validated testing methods for traits would satisfy the unmet need and bring much-needed legitimacy into the rapidly growing cannabis and cannabis-based goods business. [010] Therefore, a need exists that overcomes one or more of the current disadvantages noted above. BRIEF SUMMARY OF THE INVENTION [011] The present embodiments surprisingly provide methods described herein that will foster and facilitate the extraction and analysis of cannabis samples, analyzing both qualitatively and quantitatively for compounds of interest within the submitted samples and verification of these compounds of interest via comparison to known standard samples. [012] Additionally, the methods described herein will facilitate the determination of the presence of specific genes critical for the production of compounds of interest and particular targets, which will facilitate genomic testing and mapping of the entire genome of entities for complete identification. [013] The methods described herein will certify fidelity to a genetic profile through a process called “clonership.” Clonership is a process of proving parentage or genetic replication within a scientific (range) of accuracy. This is accomplished by way of an informatics-based method that can compare two or more genetic profiles. Once proven, the product may be certified to carry the brand, thereby honestly signaling the brand’s medicinal value to the market. [014] Each of these critical elements will be made possible via the utilization of the innovation of sample collection/processing/analysis described herein. [015] While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following
88209.413709 detailed description. As will be apparent, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the detailed descriptions are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS [016] Figure 1 depicts ligand/target interactions. [017] Figure 2 depicts the bottom half of a cassette. [018] Figure 3 depicts the internal shell of the cassette. [019] Figure 4 depicts the inner workings and mechanical grinding action of the cassette. [020] Figure 5 depicts the front of the cassette. [021] Figure 6 provides an assortment of key intermediates as well as the meroterpenoids of interest within a cannabis plant. [022] Figure 7 depicts a schematic representation of a genetic comparison and analysis system. [023] Figure 8 depicts a schematic representation of a genetic identification and supply chain verification/validation process. [024] Figure 9 depicts a schematic representation of a central laboratory system. [025] Figure 10 depicts a schematic representation of a satellite laboratory. [026] Figure 11 depicts a schematic representation of a public blockchain system. [027] Figure 12 depicts a schematic representation of a private blockchain system. [028] Figure 13 depicts a schematic representation of Dynamic Non-Fungible Token (dNFT) usage for Identification and Branding [029] Figure 14 provides exemplary cannabinoid and dopaminergic receptors. [030] Figure 15 depicts formulation table for dynamic scoring of affinity, efficacy, selectivity, and enzyme analysis [031] Figure 16 depicts an example of the formulation table for dynamic scoring of affinity, efficacy, selectivity, and enzyme analysis
88209.413709 [032] Figure 17 depicts an example of a receptor’s affinity and efficacy scoring with in the assay engine & resolver module in the CDR System [033] Figure 18 depicts an example of a receptor’s enzyme fidelity scoring within the enzyme detection and analysis module in the CDR System [034] Figure 19 depicts a dynamic scoring module – scoring example within the CDR system. [035] Figure 20 depicts a dynamic scoring module – match criteria central data repository (CDR) system. [036] Figure 21 depicts Clonorship Module match criteria with CDR system. [037] Figure 22 depicts dNFT and fractional dNFT Workflow. [038] Figure 23 depicts CDR blockchain/ERP Workflow. DETAILED DESCRIPTION [039] In the specification and in the claims, the terms "including" and "comprising" are open-ended terms and should be interpreted to mean "including, but not limited to. . . . " These terms encompass the more restrictive terms “consisting essentially of” and “consisting of.” [040] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural reference unless the context clearly dictates otherwise. As well, the terms "a" (or "an"), "one or more" and "at least one" can be used interchangeably herein. It is also to be noted that the terms "comprising", "including", “characterized by” and "having" can be used interchangeably. [041] The embodiments described herein are comprised of three essential parts: the genetic identification of cannabis, non-fungible traceability of identified cannabis throughout the supply chain process, and non-fungible certification of cannabis providing consumers’ verification of its genetic value and authenticity. The genetic authentication of cannabis is dependent on several bases. The embodiments depend on testing parameters of cannabis materials, including specific genetic analysis via comparison of genetic measurements. The methods
88209.413709 comprise pathways to the material collection as well as material processing. The collection and processing of materials will then lend to specific methods for testing the relative concentrations of cannabinoid compounds and other meroterpenoids of interest (Figure 6) where in meroterpenoids are the specific secondary metabolites produced by cannabis plants. These include but are not limited to cannabidiol, cannabidiolic acid, cannabinol, cannabidiolic acid, cannabigerol, cannabinolic acid, cannabielsoin, cannabigerolic acid, cannabidivarin, cannabichromeric acid, trans- ∆-8-tetrahydrocannabinol, and/or trans-∆-9- tetrahydrocannabinol. Each of these different compounds is present in varying concentrations depending on the strain of the plant. The concentrations of these compounds are in part predicated on the presence and overall expression of particular cellular processes that dictate the formation and synthesis of said compounds including the presence of specific enzymes. The enzymes and expression are contingent on single nucleotide polymorphisms (SNPs). These ratios can be used to identify specific strains of cannabis and help ensure the amount and quality of compounds of interest. [042] The methods described herein, as previously mentioned, also provides a pathway to perform genetic testing, allowing examination of the presence of genes that encode for the enzymes, dictating the presence and amount of particular meroterpenoids deemed of interest within plant materials. Furthermore, the methods facilitate comparative analysis for verifying genetic purity and/or proof of origin via total genetic mapping, if necessary, in addition to clonership. The innovation lies in the ability to rapidly and efficiently collect, process, and test samples without the need for advanced lab equipment or sample “work-up” which can introduce error, contamination, and false readout-outs in pharmacological testing. [043] Non-fungible traceability enables genetic authentication in the supply chain. This creates the potential for increased price elasticity, as the genetic identity and its value potential can be proven. The genetic identity and authentication is documented using blockchain infrastructure, ensuring it cannot be copied,
88209.413709 substituted, or mistaken for another genetic signature. Decentralized certified laboratories maintain access to a centralized data repository, and the product in its various forms is verified against the genetic control substance. At the end of the supply chain, the product is verified to prove its authenticity, thus capturing its potential value. Finally, the transactional elements of this process are facilitated by the blockchain infrastructure workflow (Figure 23). [044] Non-fungible certification enables genetic authentication for consumers. Consumers use unique identifiers, i.e., dynamic nun-fungible tokens (dNFT) to access the genetic identity of a product or its comparative ranking against products with similar attributes. They can use computer applications to scan this unique identifier and find all off-chain data attributed to the product. Once queried, the consumer may access the product’s receptor stimulation potency, including but not limited to affinity, selectivity, and efficacy at said pharmacological receptors and comparative rankings of a product’s receptor stimulation. This data provides consumers with valuable insight into the effect the product may have on them based on genetic profile, the validity of the product throughout the supply chain, the off- chain data comparison to other genetic profiles, and the price (Figure 23). [045] Sample Collection [046] Encapsulation of plant (cannabis) material in a hermetically sealed container (cassette), which is sterile and protects from oxidation, over exposure to moisture, pathogens or other potential contaminants. Cannabis source materials (stems/veins/etc.) can be collected with the sampler kit and will be tested via the process therein. The cassette facilitates the screening and analysis of acquired materials via internally contained sample prep that lends to further examination. Extraction and isolation of particular components through the sample prep are streamlined, allowing for rapid access and testing up to and including the previously mentioned. Novel genetic testing parameters and species identification from a procured sample. This is achieved without the need to undergo extensive pre- processing and transport to the testing facility within an enclosed loop, thus
88209.413709 potentially transporting to processing labs with respect to by-laws and guidelines of various municipalities. [047] The sample collection and preparation described herein can be used and it will be evident to those skilled in the art that the described methodology can be utilized without explicit details within each step. [048] Plant material, such as a stem, can be cut from the source and then placed into the cassette (1) via sample feeding slot (2) into the sealed container/cassette (Figure 2). The cassette is a self-contained unit composed of high-density polyethylene (HDPE). The internal shell is separately encapsulated inside the larger housing unit to ensure security and fidelity of the sample through transport and processing. The outer shell is also composed of HDPE with a centralized port that directly links to the cassette's inner core, where the sample can be passed through. The double shell approach solves the shortcomings of several currently used storage models for plant materials. It provides an additional layer of high tactile strength materials to store samples in without the potential for damage or contamination to occur due to breakage from fall, stacking, or tampering seen and possibly occurring with single housing unit cassette set-ups. [049] Plant samples, such as cuts from stems or leaf, can pass through the designated feeding slot (2) on the cassette and safely be ready to shipped and stored for transport. However, the innovation of the proposed cassette is that, to the best of current knowledge, is the facilitation of a self-encapsulated sample-processing unit within the cassette that is further supported and protected by the dual shell design (Figure 3) presented here. The internal shell of the cassette (Figure 4) holds within a mechanical grinder, which is able, with high precision, to macerate samples into a powder/pulp mixture, which since self-encapsulated through double shell design, is incapable of leakage or sample loss after processing. Herein, the cassette solves a significant problem during sample prep as plant samples are often macerated in external blending or grinding devices, and the precision of transfer of pulverized material to further the process of distillate and isolate formation is within
88209.413709 doubt and question. The innovative approach presented by the cassette eliminates this problem, as initial sample processing is self-contained with no transfer points occurring, resulting in the high unlikelihood that the sample will be lost and unable to be further carried on through additional sample prep, extraction, isolation processes, etc. [050] The mechanical grinder (Figure 4) is located, e.g., centrally, within an inner core of the inner shell (3). The HDPE construction of the inner shell includes that of a non-stick HDPE inner surface. This further facilitates and ensures the lack of loss from sample processing which is seen and documented in other sample preps, including transfer cases and cassettes of different construction from what is presented here. The mechanical grinder can be operated via a manual control unit located on the side of the cassette. Hand operation is able to disrupt the fidelity of sample via the sheer forces of the gears, and more pressure applied and push force applied to the manual apparatus will result in higher sheer forces on the contained sample, allowing sample submitted or end use processor to prepare sample for further processing before or after transport or storage within a self-contained unit. Again, this 2-way go set-up allows for the preservation of sample for processing without introducing potential contaminants or loss due to sample transfer currently seen with the existing storage cassettes and apparatus. [051] The mechanical gears located within the central inner shell subunit of the device themselves are composed of non-stick, corrosive-resistant steel or similar material. Unlike many processing units, this design will be able to hold up to any of the solvents utilized within the self-contained sample processing in the cassette. This innovation further allows the cassette to serve as a centralized processing unit that can be utilized for both sample preparation and transport in the same central unit. Facilitating ease of handling and transport and prevention of contamination, leakage or other related issues. 1. The grinding gears will contact with submitted materials in a top-down manner where the grinder (4) will be in direct contact with sample material in the main storage compartment (3) (Figure 4). The HDPE coating
88209.413709 again facilitates smooth processing as a sample, even with the friction created from grinding/maceration of the gears, will not stick, ensuring that all available sample is available for further processing. [052] Via the dedicated reagent port (6) (Figure 5), particular reagents, including organic solvents, can make available compounds of interest for extraction and analysis without destroying the fidelity of genetic materials that also may be examined within 1-pot of the device. As an example, the meroterpenoids that are present in highest concentrations as per insinuated by literature are all organic solvent soluble with various levels of lipophilicity. As such, in order to prepare for extraction, macerated samples can then be exposed to organic solvents such as methanol to set stage for compound of interest extraction. In addition to ethanol, acidic agents such as diluted sulfuric acid can be introduced to protonate certain excipients that may be in the sample, forcing them to eventually become more water soluble and consequently rinsed out once the sample inside of inner shell of cassette is exposed to an aqueous wash via the reagent port. The reagent port itself allows for the existence of this newly made fluid mash to be stored securely and sealed within the cassette, facilitating transport of a pre-processed sample to a testing facility. One aspect is that the pre-processing can now be conducted before sending out samples to where experimentation of extraction methods can occur from core user before sending out for sampling, resulting in potential cost savings on processing for back-end users while avoiding the potential issue of unknown extraction processes that may occur when just a raw sample is sent. This feature in the cassette introduces more control and opportunity for a front-end user to sample prepare their own sample to standards agreed upon by the internal user before being sent off to central testing lab. [053] Mixtures within the cassette on the back end with testers can then be removed from the cassette via precision syringe in order to assist in analysis (Figure 5). Conversely, the original raw material sample can be simply stored within the container and itself shipped off for processing at a designated testing facility
88209.413709 without the need for sample prep and examination of the target compounds of interest. [054] There are numerous classes of natural meroterpenoids that exist within cannabis plants. Samples collected can be separately utilized via the presently presented sealed container for particular % presence of compounds of interest. In brief, upon mechanical disruption within the cassette (1), via the reagent port (6), 90% ethanol can be injected to the sample cassette for initial extraction of related compounds of interest pull. Once ethanol has been introduced, a sulfuric or some other aqueous acidic reagent can be then added into the cassette via the injection port. This acid wash facilitates the formation of distillate by facilitating the removal of excipients that are more water soluble than organic in nature as for example, cannabinoid/meroterpenoids prefer organic solvents. Following this, via the same injection port, ethyl acetate can be introduced to create an organic layer cut in which choice materials should gravitate towards. Uncharged, lipophilic molecules derived from plant materials of interest will then be located within this organic layer, with non-wanted material located in aqueous, thus allowing for transport and storage of processed sample to testing facility without worry of contamination via transport. This is significant as the removal of contamination during or on back end of transport before testing as now been significantly mitigated, which to according to current knowledge, is not addressed via other technologies. [055] From the cassette, samples can be removed to facilitate the further testing of compound percentage make up from sample. In addition to ethyl acetate, di-ethyl ether can also be utilized as extracting solvent for meroterpenoids of interest. These solvent cuts of compound again will be self-contained within the inner shell and removed upon extraction from the cassette at the Central Laboratory for further analytical testing including comparison against noted in-house control samples of meroterpenoids of interest. [056] Standardized samples of each of the meroterpenoids of interest will be used to analyze and determine the presence of meroterpenoids within the sample.
88209.413709 Standardized samples will be sourced from noted and accredited sources including but not limited to Sigma-Aldrich to which analytical fidelity and purity will be demonstrated to be >98%. [057] Cassettes and subsequent samples are managed by a dynamic non-fungible token (dNFT), to access the genetic identity, and supporting the sample intake verification process. [058] Calibration curves for compound assessment [059] Calibration curves of standardized and purified in-house samples of each compound previously mentioned (meroterpenoids of interest within cannabis plants) will be pre-made, representing varying concentrations ranging from 0.1 ng/mL as a lower limit of quantification to upwards of 25 ng/mL. These ranges are expected to capture broad scope, the expected ranges of concentrations present from variety of plant samples provided. Extracted samples from the cassette device will be analyzed via LC-MS using 3 different solvent systems to ensure maximized signal to noise ratio on the LC-MS and results will then be compared to the standardized calibration curves generated from in-house samples to verify and quantify the presence of desired meroterpenoids. Solvent systems will be based upon existing literature precedent and modified where needed to facilitate analysis. Baseline systems of analysis will utilize samples already coming pre-processed in either an ethyl acetate or diethyl ether solution, to which each will be exposed to a solvent system starting at 30% of the organic cut sample processed vs 70% hexane. Gradients of ± 5% of counter solvent (hexane/alcohol water/octane) will be examined to determine best separations. Utilization of LC-MS will allow separation and identification via proven chromatography of meroterpenoids by separating compounds from complex mixtures, including those of sample prep, as well as ionization to further separate and identify compounds by structure. The calibration curves generated from solvent systems utilized will then facilitate accurate and precise quantification of materials present within submitted samples via the liquid chromatography and definitive qualification via the mass spectrometry, hence the
88209.413709 use of the LC-MS dual set-up. Collected samples will be compared to in-house standards via sample runs of n=5, allowing for elimination of 1-2 outliers where fit and necessary. [060] Meroterpenoids of interest and the ability to extract these via a simple sample prep, facilitated by the cartridge is unique in that allows for rapid sample preparation, transport and subsequent analysis for presence and purity of compounds. In addition to this, the presence and subsequent extraction of meroterpenoids also lends to the pharmacological screening assay for the biological activity capability of meroterpenoids of interest. Proper pharmacological screening is predicated on the testing of clean, unadulterated samples of compounds of interest to determine key elements such as affinity and binding, thus sample preparation is of consideration. The methodology enclosed within via its isolation and extraction of compounds of interest fosters this testing paradigm. The same sample prep utilized for LC- MS chemical analysis also facilitates the sample analysis for pharmacological testing. There is a particular screening parameter for pharmacological therapy and the pharmacological assays that extracted samples will be exposed to that is novel in its approach, considering particular ratios. These ratios include receptors of the central nervous system that in previous practice examined as standalone but not in a multiplex in where compounds derived from samples will be tested against numerous receptors of the central nervous system via in vitro assays. In brief, the assay consists of specific and isolated cells for a series of central nervous system relevant receptors, linked to known biology and pharmacology of clinically relevant outcomes. These include but are not limited to the dopamine receptor system, serotonin receptor system and opioid receptor system. These receptors will be derived from standard practices of cloning into Chinese hamster ovary (CHO) cells, as found in previous literature, and expressed in vitro as CHO as an expression and testing system is well established in practice. Upon expression of particular receptors of interest, compound will be measured for affinity and then efficacy using standardized assays, as found in literature.
88209.413709 Compounds derived will be screened across selected CNS receptors of interest to determine attuned ratios of activity. [061] The cassette technology has the capability to simplify not only transport of samples of interest, but also makes sample prep simplified for not only analytical chemistry and subsequent qualitative and quantitative measurement but also in conjunction with facile application to pharmacological assays to determine biological activity both from a potency and selective standpoint. The ability to take processed samples straight from the cassette to apply to in vitro pharmacological assays is unique as it is, according to current knowledge, the first use in a manner like this for rapid utilization. This avoids the issue that currently exists with sample preparation for assays as; less than perfect samples gives potentially misleading results including lack of activity or hyperactivity or lack of selectivity of samples. [062] The meroterpenoids of interest are secondary metabolites produced from cannabis plants in varying quantities. These are in large part determined by the presence and activity of particular enzymes within the plant that dictate the production of these compounds. These enzymes themselves are coded by proteins, which in turn are determined by particular genes. The method herein disclosed also lends itself to isolate plant material and prepare sample for the analysis of the presence and expression of these particular genes providing excellent complementary screening to compounds of interest, as there is a direct correlation between per weight concentration of compounds of interest and particular enzymes that oversee the production of compounds of interest. [063] Scientific Sample Preparation of Gene of Interest Analysis [064] As described previously, plant material such as a stem can be cut from the plant source and then placed into the cassette (1) via sample feeding slot (2) into the sealed container/cassette. Upon mechanically processing, as described before, particular reagents including detergents and/or lysing enzymes will be introduced to complete lysis of material and make available genetic components. To elaborate, once raw plant materials including, stem, seed, leaf are placed into the cassette via
88209.413709 the feeding slot, these materials will wind up in the inner shell of the cassette. At this point, the cassette could serve as a sterile, safe and secure storage or holding unit to either long-term store or ship plant material. Furthermore, the cassette can also act as a sample processing unit via its ability to process sample either on-site from the donor of material or at the Central Laboratory once the sample is sent out. Herein lies and advantage as the disadvantages seen with other known sample preparations lie in the difficulty to pre-process a sample to send off for testing without loss of material or potential exposure to contamination and sample risk. The present embodiments offer mitigation around this shortcoming seen with other sample preparations while also providing on the back end, a fully processed sample without loss of valuable material that can occur during transport due to the dual shell design. A processed sample that can be contained with the cassette facilitates ease of further genetic testing. In combination with ability to also sample prep and process for chemical isolation and extraction, the cassette serves as a tool for dual sample preparation for plant analysis. [065] With regards to genetic material extraction, once plant material is placed inside the cassette, complete maceration due to the mechanical gear and sheering force happens within the self-contained unit. High efficiency is achieved as sample has very low likelihood to escape as in other known sample preparations, with complete breakdown of tough materials such as plant walls that will facilitate complete genetic exposure to sample preparation for genetic analysis. Samples housed within the syringe will be further processed via exposure to neutralizing agents, followed by an alcohol wash to precipitate out target materials. These steps can/will occur in an adjoining sample preparation kit. The sample prep kit itself includes reagents to facilitate analysis on a chemical/biological standpoint. These include various lysing agents for cell wall and membrane breakdown, neutralizing agents to stabilize sample and astringents to foster sample work-up as similarly seen in standard wet-labs. In brief, the kit will contain select -ases (lysing tools), in
88209.413709 addition to organic alcohol solvent, charcoal based neutralizer and distilled water washes. [066] Target material in the alcohol precipitate can be dissolved in water via syringe and injected back into the storage port of the sealed container where it is suitable for storage and/or transport (7). Conversely, the original raw material sample can be simply stored within the container and itself shipped off for processing at designated testing facility without the need for sample preparation. [067] These embodiments allow for mitigation against two current disadvantages. 1. Non-processed samples often are exposed to possible contamination during packaging or transport, which may disrupt accuracy of testing on back end for laboratory facilities. 2. Transport of certain plant materials across jurisdictions is potentially problematic. The cassette presents an enclosed system to help avoid shipping issues as well as a stable system of transporting pre-processed samples that will retain quality for rigorous testing which also helps avoid against any jurisdiction restrictions around work with plant materials. [068] Receptor Screening [069] Among other features, the Central Laboratory System contains all Receptor Assays, which act as the control group by which scientific samples are compared. These assays are designed to test scientific sample affinity, selectivity, and efficacy against specific physical receptors Assays as previously described will determine affinity, efficacy and selectivity to particular receptors of interest within the central nervous system, including dopaminergic, serotonergic and opioid receptors in a manner where compounds derived from samples of interest will be challenged against selected particular receptors for ability to bind as well as activate. . The measurement and scoring of each scientific sample establish a Novel numeric value. These values allow for a Dynamic Ranking of all other scientific samples in the Central Laboratory Database associated with a specific receptor. Blockchain-based time-stamping process records data within the blockchain system, proving the Scientific
88209.413709 Sample’s existence and performance metrics relative to other scientific samples at a specific time and date (Figure 8). The time-stamped, decentralized universe of genetic data and its comparative relativity to specified physical receptors is a Novel market feature. [070] The Central Laboratory System is connected to Satellite Laboratories (Figure 9) by a network of decentralized blockchain nodes within a public blockchain system, comprising the GenoPheno System (Figure 10). Scientific Sample data enters into the Central Laboratory System using the public blockchain interface module; the blockchain node generates a time-stamp, enabling real-time rankings of Scientific Sample receptor performance. The Central Laboratory System accepts the Scientific Sample and may compare Scientific Sample to Novel receptor assay datasets within the Central Laboratory’s Assay Engine and Resolver Module. Scientific Samples are scored, compared, then ranked against all other Scientific Samples in the system. [071] A sample’s rankings may change with each officially recorded and calculated ranking updated in the system. Each ranking is able to provide quantitative and qualitative insight into sample submitted as the ranking examines both genotype and phenotype qualities with subsequent available in vitro pharmacology. The first time a sample enters the system it is genetically authenticated, once authenticated it is referred to as a Scientific Sample and is compared to receptor assays, and its potency is determined. Potency being defined as affinity along with efficacy as well as selectivity. A person skilled in the art will be able to comprehend the Scientific Sample’s receptor affinity, selectivity, and efficacy. The scoring of these Scientific Sample’s attributes is Novel by way of numeric scale, the association to one or more receptors, and fidelity and presence to one or more metabolic enzymes. The presence of particular metabolic enzymes, the custom scale, ratios, and expression efficiency create a Novel, differentiated
88209.413709 comparative representation within the total universe of Scientific Sample’s within the system (Figure 17). [072] The totality of scientific sample in the system is compared and ranked according to attributes. Qualitative analysis of these results is conducted by query of verified results. Users may request rankings for a multitude of custom receptor queries eliciting responses from the Central Laboratory. [073] Scientific samples may have multiple representations including: seeds, plants and by extension plant parts (leaf/stem/pistol/etc.) extract, isolate, various processed representations, commercial or medical consumable products. However, the system is premised on single source of Scientific Sample’s during the genetic authentication process. Users may query Scientific Sample’s based on one or more representations, but these representations stem from a single genetic source. Hybrids derived during the genetic verification process, may contain more than one source of Scientific Sample’s, but genetic authentication, enzyme analysis, and receptor affinity, selectivity, and efficacy is derived from a single source of Scientific Sample’s. Verified products are labeled with a unique identifier, i.e. dNFT (dynamic non-fungible token using the ERC 1155 standard), or other mechanisms to access the product certifications, some or all Scientific Sample, traceability attributes, scoring, ranking, and additional products consisting of the same Scientific Sample. Commercial products certified with one or more scientific sample contain the same traceability attributes, but each scientific sample independently contains scoring, ranking, and all other aspects tied to an authenticated genetic profile (Figure 23). [074] Dynamic scoring and ranking create a live view of the market for consumers. A consumer seeking a strain of cannabis intending to stimulate analgesic receptors will use this system to find the highest-ranking strain. Furthermore, the system allows the consumer to determine the highest-ranking strain with multi-receptor activity, enabling a new level of qualitative and quantitative consumer analysis.
88209.413709 [075] Dynamic scoring and ranking of a strains ability to stimulate particular receptors as well as for affinity, efficacy and selectivity at a particular receptor enables qualitative and quantitative valuation. When two or more strains are comparatively ranked by features, the consumer perceives benefit and makes rational selections. Perceived benefits also enable the ranking between strains and external products (i.e., Pharmaceuticals) with similar beneficial properties. [076] Dynamic scoring and ranking create a live view of the pricing for manufacturers. Dynamic scoring and ranking will drive consumer sentiment, when captured this activity will drive the decision making of manufactures; and selecting strains for products will be driven by consumer sentiment. [077] Ranking consists of the following critical elements. 1st, fit with receptor of interest hereunto known as receptor affinity. Receptor affinity will be based off isolated compounds of interest associated with attributes or possible claims of value-add biologically active agent’s capability to bind to a particular receptor. These receptors include but are not limited to central nervous system associated systems including cannabinoid and dopaminergic receptors as well as opioids (Figure 11). [078] 2nd, activity at said receptor hereunto known as receptor efficacy. Efficacy will be measured by determining ability of isolated compounds of interest associated with attributes or possible attributes of value-add biologically active agent’s capability to not only bind but also activate receptors of choice as measured by particular assays of choice. Full agonists, partial agonists, reverse agonists and antagonists will be determined. [079] 3rd, expression efficiency of key enzymes responsible for production of isolated compounds of interest. Compounds of interest, such as, meroterpenoids from cannabis plants, are biosynthesized by complex chemical pathways dictated by particular enzymes that are themselves coded for by particular genes. The % expression of these genes determine the amount and efficiency of enzymes
88209.413709 produced isolated compounds of interest. This feature is captured within the ranking system as attributes to consistency of quantity with a particular compound. [080] 4th, selectivity of the receptors over other targets will also be incorporated in, determining an overall score of the compound in question according to the Scientific Sample scale. Selectivity will include the ability to bind to and stimulate a receptor at a higher ratio and percentage than others. Scoring will entail weighted averages of receptor affinity, contrasted with efficacy or lack thereof at receptors, and factored against production of gene. Scoring will have the following equation: [081] Receptor Affinity (in where affinity <100 nM will be scored on a sliding scale in where low numbers would result in higher “score.” An example would be <1nM would correspond to a score of 10 while > 200 nM would score as a 1. [082] Receptor efficacy where efficacy will be measured with standard assays and scoring will be based on impact levels ranging from nM to pM with a weighted score given to more “potent” analogs. Potent analogs in similar fashion where ≤1 nM is equivalent to 10, 1nM-10nM is scored as a range of 9 and so on (see scoring table) [083] Selectivity similarly will be scored on 1-10 point scale in where >200 fold equals 10 where 1-fold equals 1 (Figure 15) . Lastly, expression of enzyme SNP will be calculated into scores as well. [084] Enzyme rank will be as follows: samples will be compared to in house standards in which THC high expression and dominance has already been established. These SNPs and location of these SNPs have been documented for as established standards of comparison for high THC production. An overlay of enzyme from sample will be made to samples and 90-100% SNP match will count as a score of 9-10. 75-89% will rank as 7.5-8.9 and so on. Overlay will be assisted and carried out via discriminant analysis in which SNPs of importance will be analyzed through the use of genome analysis toolkit. Dynamic scoring will then be generated via the following algorithm
88209.413709 [085] Weighted score of Affinity (.25) + Efficacy (.25) + Sensitivity (.15) + Enzyme (.35) averaged. Average of this weighted score divided by 4 then multiple by 100 and divided again by 2.5. Formula as following [[(A+E+S+EZ)/4] x 100]/2.5 (Figure 15). [086] Scoring will be on a highest score in which a 100 point scale in which 100 equals the highest levels of rank activity, selectivity efficacy and enzyme activity which directly translates into enzyme production. This score will then be given alongside the quality of a sample against biological target, such as pain/sleep/anxiety. [087] Where binding and efficacy concentration will be determined on a sliding scale based of nM concentrations such as follows (Figure 12). [088] Ranking will be determined based off scores from assay results as well as perceived metric of pharmacological value based for WHO quality of life calculations and overall impact of QALYs also known as quality adjusted life year. [089] Together, the Central Laboratory and Satellite Laboratories provide the intake for samples and ultimately document a subject’s genetic value, where value is established as a strain producing relevant biologically active components that can be attributed to claims of utility, purpose, and value. Furthermore, the Central Laboratory and Satellite Laboratories will establish a dynamic system to certify authenticity at various points throughout the supply chain, facilitate payment and purchase, and facilitate the scoring and dynamic ranking of genetic profiles, while the blockchain system serves as the bridge between both systems time-stamping a subject’s existence in a decentralized constellation of independent laboratories. [090] Clonership [091] The system employs the Clonership method to facilitate the application and restriction of naming configurations for genetic profiles. The system enables genetic profile owners to register a brand, defined as a word, words, phrase, or design, or a combination that identifies a genetic profile,
88209.413709 distinguishing it from other genetic profiles. Once a genetic profile is registered within the system, and a brand assigned, genetic fidelity is defined by a 92% genetic match ± 3% is required to use an assigned brand. Genetic profiles that fall outside of a 92% genetic match ± 3% shall not use an assigned brand. Clonership’s blockchain-based time-stamping process, records data at the Central Laboratory or Satellite Laboratories, proving the sample’s existence and branding at a specific time and date, facilitating a first-to-file system for branding configurations, and establishing verification thresholds for comparative analysis and certification of its branding authenticity. (Figure 21) [092] For example, Acapulco Gold is a well-known cannabis brand. The universe of products usurping the brand’s consumer recognition is broad, and its genetic footprint is vast. Acapulco gold products may share little genetic resemblance. Clonership identifies genetic parentage and creates a Novel range within the accepted confidence level. The time and date provide a first-to-file advantage within the system, documenting ownership, branding, and market relativity. Once the Acapulco Gold brand is claimed, its origination is assigned to the genetic profile, other genetic profiles with a 92% genetic match ± 3% may claim genetic fidelity, certifying lineage and phylogenetic relation with progenitor strain. [093] The technique described herein for elucidating the origin of a genetic strain, be it clone/parent or hybrid with hybrid being defined here as sample containing two or more plant DNA. It is believe that for the 1st time, the processes herein establish a methodology to seamlessly extract and analyze genetic plant material to establish “clonership.” [094] Clonership, noted earlier, as the process of proving parentage or genetic replication within a scientific (range) of accuracy, can be established on particular genes and gene ratios. The ratios will be baselined via parents within a collected database for consistency and then compared to submitted samples for determination. Genes in addition to all associated polymorphisms of genes will
88209.413709 serve as the definitive markers of interest in which samples will be compared against standard references and other comparison materials and provide confidence intervals with both upper and lower limits of probability. Single nucleotide polymorphisms (SNPs) can occur all along the genetic sequence within organisms including plants. These SNPs may lend to unique characteristics within plants including cannabis. At this juncture, to the best of the inventors’ knowledge, SNPs are not being utilized to classify “parent” strains of cannabis nor are rapid sample preps facilitating the ability to test for SNPs amongst cannabis samples. In testing for SNPs, a potential competitive advantage is provided for cannabis suppliers as the present embodiments will be able to present with them the power of information as to which enzymes in their strains are most highly expressed. This is an advantage as the SNPs themselves determine the enzymes which themselves controlled the metabolism of plant-produced products, such as the meroterpenoid secondary metabolites found in cannabis plants. At this time, it is not believed that the utilization of SNP analysis via sample prep and collection has been used to directly correlate with the amount or type of meroterpenoids produced by cannabis samples. This is a disadvantage within the cannabis industry that the present embodiments are able to overcome. [095] Thus, the present sample preparation in addition to lending itself for the extraction of compounds of interest is able to step further by also allowing the processing of genetic material to exploit and examine the actual SNPs that may be present resulting in differentiation of parent versus clone strains of cannabis plants. [096] The use of bioinformatics will facilitate the analysis of quantification of differences between specific gene variations and will be facilitated by standardized statistical analysis where submitted parent/clone or hybrid materials will have measurements conducted from as submitted sample (DNA and/or otherwise) and using informatics approach, specific information will be captured. This stems from the ability to examine the individual alleles from genetics found in the 20 different chromosomes within the cannabis plant. The method of extraction and sample
88209.413709 preparation previously mentioned allows for the acquisition of this information as the sample preparation provides accurate analysis. [097] Statistical analysis in which degrees of genetic similarity/dissimilarity between submitted materials or between submitted materials and standard reference (control) materials will result in the probability of genetic match to comparison samples within a range of significance. Statistical analysis in which probability of match lies above the upper threshold for match will provide evidence that match of parent/clone or hybrid strain don’t have gene/s or SNP/s definitive markers, thereby not matching to the degree to definitively state a match. Conversely, the probability of match can be made with high confidence if statistical analysis is between the lower threshold and the upper threshold, where the definitive markers of interest for the plant material, if present, should fall within a range. Hybrid strains will be clearly identified as such, as they will have similar yet distinct genes of interest and SNPs from parent material. This is in part due to the nature of hybrid strains having at least one other set of genetic origin material present within submitted samples. Comparative analysis via informatics to an existing database will demonstrate that hybrid strains will be no greater than a 95% match according to lower and upper threshold limits. Additionally, genes within hybrid strains themselves can be matched with good confidence to the original contributor strains when analytics falls between lower and upper thresholds. [098] Genomic measurement is facilitated by the sample preparations described herein. Upon sample preparation, various techniques to establish genetic origin can be utilized. These include the use of polymerase chain reaction to amplify genetic material and subsequent analysis of genetic material using the current state of technology and tools. These will be SNP genotyping and microarrays, along with standard Sanger style sequencing. Other tools utilized to identify specific genes of interest will be fluorescent in situ hybridization, high throughout genotyping and comparative genomic hybridization to examine ploidy between samples submitted which will assist in the measurement of parent/clone and determination of such vs
88209.413709 hybrid strain samples. Other genetic testing paradigms can be included and used as stand-alone or in combination to map out genetics of submitted sample materials for comparison. These assays are all amenable based on the rapid sample and preparation and processing described herein which differentiates from known standard protocol preparation, which typically require laboratory infrastructure to facilitate. Upon analysis, informatics assisted reports will detail findings from genetic testing including breakdown of source material and genetic origins and how these translate to the chemical composition of compounds denoted of interest from plant materials. [099] Enzymes of Interest Examination [0100] In addition to examination of cannabis alleles across the entire sequence of plants, the sample preparation will also facilitate specific examination of key genetic characteristics. In particular, enzymes themselves involved with meroterpenoid synthesis. Type III polyketide synthase (PKS), olivetolic acid cyclase (OCAC), THC-A synthase (THCA-syn) and CBD-A synthase (CBDA-syn) are the key enzymes involved in the production of the key intermediates as well as the meroterpenoids of interest within the cannabis plant. (Figure 5) Polymorphisms in enzymes themselves can dictate the production of materials. [0101] Specifically, THCA-syn polymorphism can lead to the production and variation of the amount of psychoactive materials produced in cannabis plants. The method described herein facilitates testing for the present of the level of expression of particular enzymes as well as for any polymorphisms. Polymorphisms in THCA- syn for example can heavily influence and dictate the amount of psychoactive components within a cannabis plant and identification of polymorphisms provide end users with an accurate approximation of how much several particular meroterpenoids per weight basis will be present within the plant. Furthermore, the identification of polymorphisms within key enzymes such as THCA- syn can also be used as a “fingerprinting” technique to determine strain of various cannabis plants as well as origin, i.e. male/female/parent/clone.
88209.413709 [0102] Currently, there is not a normal practice or facile sample preparation approach to determine the expression of enzymes which dictate level of cannabinoids within plant samples. The present cassette device, in addition to the sample preparation that follows, facilitates ease of sample process and testing for particular elements involving enzymes, stemming from the SNPs that dictate these. [0103] Specifically, single nucleotide polymorphisms (SNPs) will be elucidated to identify the features of interest within submitted samples. SNPs within the genetic sequence of enzymes provide more detailed identification of cannabis strains and associated enzymes that produce secondary metabolites of interest, such as the meroterpenoids. The advantage lies in the fact that a SNP with the enzyme may alter the fidelity and function of key enzymes, however, the SNPs may also be silent in terms of activity but still differentiate strains, further helping to isolate patentable strains from the existing genetic diversity that exists within cannabis strains. At this time, SNPs are not being utilized to defend patent position and the current methodology will facilitate differentiation of strains via presence of specific enzyme (aforementioned) expression as well as particular SNPs of interest within each of these enzymes, thus allowing a higher and more precise level of identification of unique strains and enzymatic features of interest for cannabis plants. Identification of SNPs that code for the enzymes that in turn determine the level of meroterpenoids within a sample is advantageous as introduced a level of consistency that is currently not seen within cannabis production. The ability to specifically know how much and which meroterpenoid will be present within a sample will, according to current knowledge, for the 1st time, allow producers to definitely make claims specific to their strain of cannabis. [0104] In support of determination of plant materials genetically, THCA-syn enzymes and associated polymorphisms, of which 16 are of note, will be examined but not alone, examination via the sample preparation will allow for determination of CBDA-syn as well including potential polymorphisms identified as standard which in this case refer to high THC-A synthase expressing strains. These include
88209.413709 but are not limited to high THC strains such as 33°, Lemon Love and Nanitro strains that can be found in Canada and have consistently been shown to have chemotypes of high THC content, associated with particular SNPs in the chromosome 1 cluster; as identified in blast analysis. SNPs can occur within strains of cannabis alone, or numerous SNPs at key positions on the alleles can occur, each of which can be captured and identified to establish identity of strains. Again, the utilization of SNPs to establish identity of cannabis strain via the enzymes that produce secondary metabolites is not appreciated within the field and will be facilitated via the present embodiments of sample preparation and testing. Examination of these enzymes along with additional markers of interest will be able to accurately provide information on genetic origin/purity/lineage. [0105] The present approach to sample preparation allows for smooth genetic testing protocols such as restriction fragment length polymorphism or single stand conformation polymorphism and/or genome mapping. These particular protocols require carefully prepared samples in order to avoid false negatives of which through the use of the present embodiments provide enclosed loop systems of sample preparation. In these assays, particular markers for enzymes and beyond will be elucidated and identification of plant materials enabled. These include SNPs of the key enzymes involved with secondary metabolite/meroterpenoid of interest production. As to with the enzymes, other markers of interest will be able to identify male/female/parent/clone plants and this will be able to be conducted via similar sample prep as to determining polymorphisms for enzymes. Other markers of interest include polymorphisms related to the physical size of plants, their growth rate and possible resistance or affinity to climate factors include aridity. (Figure 18) [0106] Blockchain Traceability, Reporting, and Certification [0107] Non-fungibility is a basis for the embodiments described herein; records certifying genetic confirmation and supply chain validation as true and accurate. Recorded in blockchain, they are certified authentic, and cannot be copied, substituted, subdivided, or assigned to another genetic signature.
88209.413709 Therefore, the genetic due diligence, supply chain records, and eventual comparative market valuation become supporting evidence for valuation and price determination that are unique and immutable. The present innovation may include systems and methods for managing and comparing genetic data and their stimulation of physical receptors. [0108] The system will, providing control over which data sources are made available to the public and who has access to it. Central data repository will contain extensive comparative analysis from the assay engine and resolver module, enzyme detection and analysis module, and results from the Clonership module. The public blockchain will distribute non-fungible genetic identification data and certifications from the central data repository to laboratory nodes, as well a dynamic scoring and ranking from the central data repository and laboratory, and non-fungible traceability and fractional non-fungible ownership and traceability of genetic identification naming configurations. [0109] Once the sample has been genetically identified, authenticated, determined secure, and time-stamped by a laboratory node within the public blockchain, the subject shall now be compared, scored and ranked against other subjects within the system, as well as being cataloged in the Central Data Registry within the Central Laboratory System (Figure 6). Additionally, the system delivers supply chain verification and commercial validation for the subject (Figure 7.) The embodiments described herein regarding Novel genetic profile analysis (genetic identification, Clonership, receptor scoring & ranking, and enzyme detection) shall be time-stamped, immutably protected, and publicly verifiable using blockchain. The decentralized collection and analysis of scientific samples using blockchain allow systemic control over publicly verifiable data related to ownership, unique identification, supply chain traceability, and provenance. Blocks of data are controlled and confirmed by a decentralized ledger system managed by multiple public blockchain nodes and a network. The system’s public blockchain nodes operate at each satellite
88209.413709 laboratory and the Central Laboratory. All laboratories issue blocks of data representing digital assets identified by a smart contract on the blockchain. [0110] Dynamic Non-Fungible Tokens (dNFT) [0111] After establishing an account, the Central Laboratory issues a scientific sample cassette or cassettes to the sample owner. Initially, cassettes are identified by QR CODE. Associated metadata, at a minimum, should include unique IDs assigned to identify the account holder and the sample lot. The cassette is sent to the account holder; once received, the sample is inserted into the cassette and sent to a satellite laboratory for general screening that may include: residual solvents, pesticides, potency, terpenes, heavy metals, mycotoxin, moisture, water activity, pathogenic microbiology, PAH, qPCR, and filth and foreign materials. Once the scientific sample is screened, results are entered into the public blockchain and become relative within the system. Next, the scientific sample is sent to the Central Laboratory for de novo genetic profile analysis. (Figure 13) [0112] The scientific sample may be received by a satellite laboratory (Figure 10) in a cassette, or larger volumes may be verified using larger containers but with the same labeling configuration. This Novel approach enables third-party genetic verification without broadcasting an entire database of genetic profiles and can be used to verify any volume of homogenous genetic material (Figure 8). If the sample is suspected to be a Novel genetic profile, the sample is sent to the Central Laboratory for genetic profile analysis. [0113] Once established in the Central Database, future samples will be identified by a Dynamic Non-fungible Token. The sample’s account holder may verify genetic material to an existing genetic profile at a satellite laboratory. The targeted genetic profile is contained within the sample’s unique identifier, a dNFT (dynamic non-fungible token using the ERC 1155 standard and containing a QR code). The QR code within the dNFT holds a maximum of 7089 numeric characters, 4296 alphanumeric characters, or 2953 alphanumeric characters with spaces and
88209.413709 punctuation is the physical limit of a QR code, as defined by ISO/IEC 23941:2022 standards. These characters are used to scientifically describe the genetic profile control material rather than requiring physical control material to test. (Figure 13) [0114] Genetic profile in this regard refers to enzymatic production and the presence of key compound-producing enzymes (Figure 7). In particular, this is THC-A Synthase, the key enzyme, and reactor to produce base compounds found within the cannabis plant into THC/THC-related compounds. Differentiation is contingent on SNPs related to THC-A synthase, as these SNPs can impact the presence and productive turnover of the enzyme. Furthermore, herein reported technology facilitates the identification of the location of said SNPs on particular chromosomes. The presence and location of SNPs are key to the differentiation between strains as this is a clear marker of genetic difference and origin. This Novel approach verifies the scientific sample by comparing one or more measurable attributes from the scientific sample to one or more measurable attributes contained in the dNFT describing the targeted genetic profile control (Figure 23). Numerical values assigned to these measurable attributes represent the targeted qualitative attributes required by the test method. Measurable attributes include several key elements. These are affinity of major compound/s found within a plant sample. This will include the most prevalent compounds isolated and extracted from the submitted plant samples. [0115] Affinity in this context refers to the isolated compound’s ability to bind to the pharmacologically and biologically relevant receptor as demonstrated by affinity screening against selected receptors of interest. Affinity is a differentiator as compounds from different strains can vary in concentration and capability to bind to receptors. Affinity “scoring” is described herein (Figure 15). [0116] In addition to affinity, efficacy will also be a measurable attribute. Efficacy in this context speaks to the ability of isolated compounds that do have
88209.413709 affinity, are able to activate receptors they bind to. Efficacy and receptor activation are critical to biological activity as activation of a receptor and subsequent signaling leads to the observable biological and pharmacological phenomenon observed. Efficacy as a differentiator will show which strains produce and have compounds that can be associated with an observed biological outcome. [0117] Another measurable attribute pertains to selectivity. Selectivity in this context refers to the isolated and extracted compounds from plant samples and how selective they are with respect to which receptors these compounds display affinity and/or efficacy to. Selectivity also differentiates samples by demonstrating that compounds produced by samples are more or less promiscuous in terms of pharmacological activity. This is key as selective compounds can differentiate and discern which samples trigger response biologically, translating to an attribute of the sample source material (Figure 15). [0118] These time-stamped data indicate an exact time of creation within the system, creating time-aware evidence for Clonership. The comparative ranking of genetic affinity and efficacy along with selectivity of receptor stimulation at selected receptors in which molecular models and representations can represent spatial interaction of ligands/receptor interaction occurs after receipt with the Central Laboratory. However, the creation of a scientific sample within the system reverts to time-stamped evidence generated at its first introduction into the system. Importantly, these comparative analyses take place within the Central Laboratory, thus enabling a real-time ranking of the genetic marketplace (Figure 16). [0119] Each data set is a unique item or idea. Each concept can be associated with multiple representations, including schematics of overlays from the genetic makeup of each plant strain sample as it relates to the physical-chemical products produced, including rations and how these may or may not stimulate
88209.413709 pharmacologically relevant receptors and the likelihood that this stimulation leads to statistically significant or documented clinically significant response. [0120] If the satellite laboratory verifies a sample matching within the accepted confidence level an existing genetic profile scientifically described within the dNFT, then the sample is confirmed certified within the blockchain system, and may be sold or contained in other products while baring the certified brand, and marketing its genetic features (Figure 23). [0121] De novo, genetic profile analysis is completed at the Central Laboratory. Upon arrival, the sample’s identifying label is scanned. The sample is then tested for genetic identification, as defined in the genetic identification section. If the sample is once again confirmed de novo, Clonership, receptor scoring & ranking, and enzyme detection may continue (Figure 19). [0122] If the sample is de novo, then the sample account holder may brand the genetic profile, as described in the Clonership process. [0123] If the sample matches within the accepted confidence level an existing genetic profile contained within the Central Laboratory System, the sample owner may license the branding reserved within the Clonership process. The sample owner may not establish a new brand within the established confidence level for an existing genetic profile. [0124] If the sample does not match an existing genetic profile, the genetic profile is considered de novo, and the Clonership process, receptor scoring, and enzyme detection may occur. These data comprise the scientific sample’s genetic profile. The Clonership process will establish a Novel-naming configuration and exclusive or non-exclusive ownership range of the defined confidence level. (Figure 21) [0125] IMMUDIBLE BLOCKCHAIN VERIFICATION AND VALIDATION [0126] Once the sample is genetically identified, authenticated, determined secure, and time-stamped by a laboratory node within the public blockchain, the subject can be compared, scored, and ranked against other subjects within
88209.413709 the system, as well as cataloged in the Central Data Registry within the Central Laboratory system (Figure 11). Additionally, the system delivers supply chain verification and commercial validation for the subject. (Figure 8) Aside from genetic testing described earlier, the Central Database contains all Receptor Assays described herein, which act as the control group by which Scientific Samples are compared. These assays are designed to test a scientific sample’s affinity, selectivity, and efficacy with the body’s receptors (Figure 14). The measurement and Dynamic Scoring of each instance of scientific sample establishes a Novel numeric value. These values allow for a Dynamic Ranking of all scientific samples associated with a specific receptor. Blockchain-based time-stamping records data at centralized or decentralized laboratory locations, proving the sample’s existence at a specific time and date (Figure 9). The time and date provide a first-to-file advantage within the system, documenting ownership, branding, and market relativity. [0127] Presently, the price of cannabis within stages of the supply chain is arbitrarily set and with little to no value attributed to attributes. Price and organic labeling are some of the only perceived features of value to the consumer. Consequently, the market has bifurcated into seeking the lowest cost and lowest organic cost. Neither having anything to do with performance. The ability to genetically differentiate strains by genetics creates new forms of perceived value, generating demand and inverting the price curve. [0128] Data may be queried by one or more physical receptors or possibly by products ranked by receptor stimulation or receptor stimulation potency, including but not limited to affinity, selectivity, and efficacy at said pharmacological receptors; by geographic location, manufacturer, brand, or retail establishment. They also may be queried by specific item or lab result (Figure 15) with the location of strain associated back to genetic variability historically associated with indigenous plant samples of the region. Furthermore, manufacturer and brand can be identified and quantified similarly, facilitating high-impact traceability,
88209.413709 including from retail outlets. This testing also allows end-users, as mentioned above, and retailers to examine all impurities or irregularities associated with similar samples for a level of quality control hereunto not seen in the field. Ultimately, the system issues the parentage owner a unique identifier (i.e., Dynamic Non-fungible Token (dNFT) assigned to the genetic parentage. Consumers may use computer applications to scan this unique identifier and find on-chain and off- chain data attributed to the product (Figure 23). [0129] STRUCTURED PAYMENTS [0130] The system may include a structured payment system. Each time product transitions between vendors, smart contracts govern the sale, portions of the sale price may be escrowed until a laboratory within a predetermined window confirms its authenticity. (Figure 23) [0131] For example, shipments received by a laboratory are secured under quarantine until authentication is established and escrowed funds are released. The system may facilitate the escrowing of funds and release the escrowed funds upon authentication of the shipment by a certified external or internal laboratory. It may also facilitate the licensing of genetics by recording sales and issuing royalty payments or payments to taxing authorities. [0132] The system may also feature fractional dNFTs to track and manage one or more owners of genetic profiles for a defined period of time, as well as payments to licensors from licensees. These licenses could be permanent in the case of branding, while matching genetic profiles could be on an annual basis. (Figure 22) [0133] For example, upon completing genetic testing, receptor scoring & ranking, and enzyme detection, a cultivator is the first-to-file the brand “Acapulco Gold” using the Clonership process, becoming the brand owner. Subsequently, ten additional cultivators submit genetic profiles falling inside of a 92% genetic match ± 3%, thereby permitting the use of the Acapulco Gold brand for the following year (Figure 20). The structured payment system could collect a 6% licensing fee for all Acapulco Gold genetic profile transactions within the system. One-third of the
88209.413709 licensing fee could be paid to the brand owner, one-third of the licensing fee could be paid to the cultivator with the closest genetic match, and one-third of the licensing fees could be divided amongst the additional certified cultivators. While the system will identify all Acapulco Gold within the supply chain, the fractional dNFT will track brand ownership and other certified cultivators with Acapulco Gold from year to year (Figure 21). [0134] The overall system presented herein, for the first time, allows a complete sample preparation that facilities advanced testing both at the chemical and genetic level. The cassette allows for facile sample preparation and transport of sensitive materials, both being able to prepare a sample for particular chemical composition testing via unique LC-MS procedures. Furthermore, via the same cassette device, one can seamlessly process samples for genetic testing, targeting specific SNPs. This is highly advantageous as these SNPs bestow the highest level of genetic differentiation and analysis for plant materials. Furthermore, they are directly responsible for the enzymes involved in meroterpenoid synthesis of compounds of interest. The enzymes themselves have not been explored in terms of identification of particular plants or the influence they have on the per-weight amount of chemical compound of interest produced. Lastly, the cassette provides the ability to process a sample rapidly for in vitro pharmacological testing of a unique suite of receptors that are considered to then link to show desired biological effects. The cassette provides the milieu to conduct such testing at each level via its innovative design and sample preparation. This is followed by specific testing and screening, advantageous compared to existing methods to definitively provide chemical, genetic and biological differentiation of plant strains, including cannabis. [0135] The cannabis industry seeks increased price elasticity based on genetic features. However, the genetic identity, authenticity, and value potential can be proven at every step of the supply chain. Once genetic identity is authenticated at cultivation, its authenticity is traceable throughout the supply chain. Blockchain infrastructure is key to ensuring it cannot be copied, substituted, or mistaken for
88209.413709 another genetic signature. As genetic value is uncovered, non-fungibility enables the supply chain and consumers to extract all possible value. [0136] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this invention belongs. All publications and patents specifically mentioned herein are incorporated by reference in their entirety for all purposes including describing and disclosing the chemicals, instruments, statistical analyses and methodologies which are reported in the publications which might be used in connection with the invention. All references cited in this specification are to be taken as indicative of the level of skill in the art. Nothing herein is to be construed as an admission that the invention is not entitled to antedate such disclosure by virtue of prior invention. [0137] The following paragraphs enumerated consecutively from 1 through 13 provide for various aspects of the present embodiments. It should be understood that where multiple steps are included in the paragraph, one or more of the steps is not required. In one embodiment, in a first paragraph (1), the present invention provides 1. A self-contained sample capture and processing unit for the collection and transportation of genetic material comprising: a self-contained sample capture and processing unit that allows for the extraction and isolation of compounds of interest within cannabis plants used to establish genetic parentage, wherein a. The method for capture and/or processing allows for ease of transport without the disruption of regulatory statues as non- regulated material from the cannabis plant is extracted (the stems); and, b. The method for the extraction and isolation of specific chemical assets of interest in addition to genetic testing for key genetic
88209.413709 markers within cannabis plants in addition to entire genome mapping); and, c. Contains a QR Code used to identify and track the parentage sample; and, d. Laboratory results are time-stamped and secured by blockchain, and/or centrally archived. A method of measuring, scoring or ranking receptor stimulation by cannabis or hemp strains by employing genetic diagnostic testing on a seed or a plant sample, wherein a. A genetic diagnostic test resulting in the establishment of a genetic control with a test requiring a minimum of (30 samples), with results indicating a confidence level of (≥95%) of the genome map and identification of genetic markers indicating stimulation of one or more physical receptors, as well as particular SNPs of interest for metabolizing enzymes germane to the production of compounds of interest; in which the scoring system works in sections of an algorithm, wherein the algorithm components comprise: selectivity of compounds produced and extracted from plant at biological receptors of interest. Efficacy at biological receptors, Levels of affinity at biological receptors and qualitative production of enzymes responsible for the synthesis of compounds of interest in plant based off genetic identification, wherein b. Precision diagnostic tests resulting in the scoring of the potency of the physical receptor stimulation at the cannabis or hemp seed or cultivation; and/or c. Genetic traceability, diagnostic test or tests to confirm the genetic identification throughout the supply chain post cultivation,
88209.413709 wherein confirming the genetic identity within extraction, processing, and/or manufacturing; d. Genetic parentage, uniquely identified by Dynamic Non-fungible Token (dNFT); and e. Laboratory results are time-stamped and secured by blockchain, and/or centrally archived. A computer-implemented method for grouping genetic diagnostic results from one or more laboratory systems; wherein satellite laboratory data is transferred and centrally processed and stored, wherein the transfer of the genetic diagnostic results is secured and time-stamped using blockchain, wherein a centralized data repository verifies a blockchain contract transactions, then translates, normalizes, scores, and/or ranks, genetic diagnostic results before storing the data in a centralized data repository, wherein the method includes a. A genetic diagnostic test confirming the genetic match between (30 samples), with results indicating a confidence level of (≥95%); and/or b. Genetic diagnostic test resulting in the scoring of the potency of the physical receptor stimulation of the cannabis or hemp seed or cultivation. c. Genetic diagnostic test resulting in the selectivity of physically stimulated receptors of the cannabis or hemp seed cultivation; and, d. Laboratory results are time-stamped and secured by blockchain, and/or centrally archived. A computer-implemented method for accepting and genetically matching physical genetic diagnostic samples to virtual genetic diagnostic results remotely collected and stored in a centralized data repository, wherein
88209.413709 once matched, genetic diagnostic results are tested against baseline control assays, including results from plurality of assays detailing the stimulation of physical receptors, wherein genetic diagnostic results are compared to one or more control assays, each entry into the centralized data repository shall represent one or more receptor categories in where established control sampled will be used as anchoring baseline measurements to contrast sample to, upon validation, a. A step for categorizing Cannabis and or hemp strains by the number of receptors and which receptors they stimulate; and/or b. A step for categorizing Cannabis and or hemp strains by the receptor’s stimulation potency including affinity, selectivity and efficacy at particular receptors; and/or c. A step for categorizing the fidelity and presence of particular metabolic enzymes on interest and in what particular ratios and expression efficiency; and, d. Laboratory results are time-stamped and secured by blockchain, and/or centrally archived. A method of grouping cannabis or hemp strains by genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor, wherein a. One or more genetic diagnostic tests indicating a confidence level of (≥95%) of the genome map and identification of genetic markers indicating stimulation of one or more physical receptors indicating Clonership; and/or b. A genetic diagnostic test resulting in the measurement of the potency of the physical receptor including but not limited to affinity, selectivity and efficacy at particular receptors; and/or
88209.413709 c. A method of ranking of the potency of the physical receptor stimulation against one or more genetic strains stimulating the same receptor; and/or d. A method of ranking of the potency of the physical receptor stimulation against one or more genetic strains stimulating the same receptor in addition to a comparison of stimulation levels for each receptor, where affinity is defined as ≤ 100 nM at any receptor of note via cellular affinity assays including but not limited to 3H and various Chinese hamster ovary cell-based tests and others, wherein efficacy hereto is defined as ≤ 50 nM on the 35S GTPγ assay, the standard for measuring receptor activity. Scores higher than these benchmarks with be captured, ranked, and/or reported in the centralized data repository; and, e. Laboratory results are time-stamped and secured by blockchain, and/or centrally archived. A method of identifying samples or product information. A self-contained sample capture and processing unit identified by a Dynamic Non fungible Token (dNFT) containing on-chain and off-chain reference information that are time-stamped, secured by blockchain, and centrally archived, and attached to a self-contained sample capture, processed cannabis or hemp, or commercial product. a. Contains on-chain data identifying genetic parentage name, time- stamp within the system, parentage ownership, reference numbers; and, b. Contains on-chain data identifying the genetic parentage profile, containing on-chain data that including Clonership identification via informatic approach of genetic materials; and,
88209.413709 c. Contains on-chain data identifying key enzymes and genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including that of any and all isoforms of enzymes of interest; and, d. Contains on-chain data identifying particular receptor screening results; and, e. Contains on-chain data related to the ration of identifying key enzymes related to the production of key compounds of interest (meroterpenoids); and, f. Contains off-chain data referencing dynamic comparative data comprising other parentage profiles and genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; Contains off-chain data referencing dynamic comparative data comprising ratio of compounds presence compared to known reference samples as well as selectivity of receptors stimulated; and, g. Contains off-chain data referencing ownership status, including exclusive or non-exclusive ownership status that may be derived from a fractional dNFT; and, h. Contains off-chain data referencing the scoring and ranking of receptor stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; and, i. May contain off-chain data referencing location restrictions; and, j. May contain off-chain data referencing various regulatory approvals and clinical data; and,
88209.413709 k. May contain off-chain data referencing, ownership web address and contact information. A system comprising satellite laboratories having directed genetic diagnostic results to a centralized data repository using a blockchain-based decentralized satellite system portal by executing blockchain contracts, genetic diagnostic results shall associate and be mapped to at least one receptor assay data set in the centralized data repository’s assay engine & resolver module, the centralized data repository having the genetic diagnostic results associated with at least one receptor or more data sets used to map the genetic diagnostic results, a method for managing at least one receptor assay in the centralized data repository, the method comprising: a. an act of receiving a genetic diagnostic results from the satellite laboratory workstation via the decentralized satellite system portal, wherein the result is associated with blockchain contract interface code provided by the centralized data repository; and/or, b. an act of searching blockchain contracts within the centralized data repository for the assay results, wherein the genetic diagnostic results are compared to one or more assay results associated with one or more physical receptors. A method for modifying the content of a centralized data repository by a decentralized satellite system, the method comprising: a. A step for determining a current representation of current physical location of data stored in the centralized data repository; and/or, b. an act of altering the decentralized satellite system’s current data representation without altering the physical receptor data in the centralized data repository; and/or,
88209.413709 c. A step for receiving input from the decentralized satellite system that identifies a new representation for the current physical location data; and/or, d. A step for modifying the current representation to the new representation without affecting a receptor identifier associated with the current representation; and/or, e. A step for committing the new representation to the centralized data repository. A method for accessing verified results of a centralized data repository by remote users, the method comprising: a. A step for accessing a current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and or hemp strains by the receptors; and/or, b. A step for accessing a current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and or hemp strains by the receptors stimulation potency; including but not limited to affinity, selectivity and/or efficacy at tested receptors; and/or, c. A step for accessing a current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and or hemp strains by the receptors stimulation potency ranking; and/or, d. Representations are limited to one source of genetic diagnostic results; and, e. Genetic diagnostic results is limited to one genetic source.
88209.413709 A method of using a centralized data repository to map genetic diagnostic results, in addition to other pertinent in vitro pharmacological results including but not limited to composition of matter and target of activity, i.e. physical receptor, received from a decentralized satellite system for storage in a centralized data repository, a method for mapping representations of the laboratory data genetic diagnostic results to the centralized data repository, the representations provided by the decentralized satellite system, the method comprising: a. a step for receiving a current representation identified by the decentralized satellite system; and/or, b. a step for searching the centralized data repository for the current representation; and, c. a step for searching the centralized data repository for the current ranking and scoring of genetic diagnostic results; and, d. a step for searching the centralized data repository receptors stimulation potency, including but not limited to affinity, selectivity and efficacy at tested receptors; and, e. a step for searching centralized data repository of enzymes and isoforms of enzymes of interest; and, f. a step for receiving instructions from decentralized satellite system; and, g. a step for managing the current representation in accordance with the receive; and, h. instructions such that the current representation is mapped to the centralized data repository. A method of creating fractional dNFTs to track and manage more than one owner of a genetic profile. a. A step for submitting parentage ownership proof; and,
88209.413709 b. A step for creating and deploying the smart contract; and, c. A step for assigning fractional ownership by shares; and, d. A step for entering the contract address; and, e. A step for entering the image; and, f. A step for entering metadata identifying genetic parentage name, time-stamp within the system, parentage fractional ownership, reference numbers; and, g. A step for entering metadata identifying genetic parentage name, time-stamp within the system, parentage ownership, ownership status, reference numbers; and, h. A step for entering metadata identifying the genetic parentage profile, containing on-chain data that including Clonership identification via informatic approach of genetic materials; and, i. A step for entering metadata identifying key enzymes and genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including that of any and all isoforms of enzymes of interest; and, j. A step for entering metadata identifying particular receptor screening results; and, k. A step for entering metadata related to the ration of identifying key enzymes related to the production of key compounds of interest (meroterpenoids); and, l. A step for entering metadata referencing dynamic comparative data comprising other parentage profiles and genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; Contains off-chain data referencing dynamic comparative data comprising ratio of compounds presence compared to known
88209.413709 reference samples as well as selectivity of receptors stimulated; and, m. A step for entering metadata referencing ownership status, including exclusive or non-exclusive ownership status that may be derived from a fractional dNFT; and, n. A step for entering metadata referencing the scoring and ranking of receptor stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; and, o. A step for entering metadata referencing location restrictions; and, p. A step for entering metadata referencing various regulatory approvals and clinical data; and, q. A step for entering metadata referencing, ownership web address and contact information; and, r. A step for deploying the smart contract to the blockchain; and, s. A step for adding the dNFT to the dNFT vault; and, t. A step for allowing the potential transfer of ownership; and, u. A step used to achieve consensus over the ledger’s state. A method of creating dNFTs to track and manage one owner of a genetic profile. a. A step for deploying the smart contract; and b. A step for entering the contract address; and c. A step for entering the image; and, d. A step for entering metadata identifying genetic parentage name, time-stamp within the system, divided parentage ownership, reference numbers; and,
88209.413709 e. A step for entering metadata identifying genetic parentage name, time-stamp within the system, parentage ownership, ownership status, reference numbers; and, f. A step for entering metadata identifying the genetic parentage profile, containing on-chain data that including Clonership identification via informatic approach of genetic materials; and, g. A step for entering metadata identifying key enzymes and genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including that of any and all isoforms of enzymes of interest; and, h. A step for entering metadata identifying particular receptor screening results; and, i. A step for entering metadata related to the ration of identifying key enzymes related to the production of key compounds of interest (meroterpenoids); and, j. A step for entering metadata referencing dynamic comparative data comprising other parentage profiles and genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; Contains off-chain data referencing dynamic comparative data comprising ratio of compounds presence compared to known reference samples as well as selectivity of receptors stimulated; and, k. A step for entering metadata referencing ownership status, including exclusive or non-exclusive ownership status that may be derived from a fractional dNFT; and, l. A step for entering metadata referencing the scoring and ranking of receptor stimulation of various receptors, and a scoring of the
88209.413709 potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; and, m. A step for entering metadata referencing location restrictions; and, n. A step for entering metadata referencing various regulatory approvals and clinical data; and, o. A step for entering metadata referencing, ownership web address and contact information; and, p. A step for deploying the smart contract to the blockchain; and, q. A step for adding the dNFT to the dNFT vault; and, r. A step for allowing the potential transfer of ownership; and, s. A step used to achieve consensus over the ledger’s state. A system comprising a laboratory, central data repository, and dNFTs immutably linked to a specific genetic parentage to track and manage the verification, purchase, and payment for hemp and cannabis within a supply chain, as well as tracking payments to licensees to licensors, and payments to government authority. a. A step for a laboratory accepting a shipment of cannabis or hemp into an inventory management system by scanning an attached dNFT; and, b. A step for testing a sample of the shipment to verify it matches the purported parentage within the dNFT; and, c. A step for accepting payment for a shipment; a, d. A step for verifying a sample matches a requested genetic parentage within the dNFT; a, e. A step for releasing the funds to the seller and the product to the buyer; a,
88209.413709 f. A step for releasing funds to a licensor; a, g. A step for releasing funds to a government authority. [0138] The following paragraphs enumerated consecutively from 1 through 13 provide for additional various aspects of the present embodiments. It should be understood that where multiple steps are included in the paragraph, one or more of the steps is not required. In one embodiment, in a first paragraph (1), the present invention provides 1. An apparatus for the collection and transportation of genetic material comprising: a self-contained sample capture and processing unit for the extraction and isolation of compounds of interest within cannabis plants, wherein the self-contained sample capture apparatus provides for a. extraction of a cannabis plant source from a cannabis source within the self-contained sample capture apparatus suitable for transportation of genetic material; b. qualification and quantification of chemical compounds of interest (meroterpenoids) identified from the cannabis plant source within the self-contained sample capture apparatus; c. a receptor screening assay is performed with clinical data read- outs from the cannabis plant source within the self-contained sample capture apparatus, wherein cannabis source is extracted to provide the cannabis plant source; and d. the extracted cannabis plant source is identified by QR Code, or Dynamic Non-fungible Token (dNFT) including selectivity, affinity and/or efficacy at receptors of interest. 2. A self-contained sample capture and processing unit that provides extraction and isolation of specific genetic testing for key genetic
88209.413709 markers within cannabis plant material including entire genome mapping, wherein the self-contained sample capture and processing unit provides: a. key enzymes of genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including identification of isoforms of enzymes of interest; b. clonership identification via an informatic approach of genetic materials including the identification of parent, clone and/or hybrid strain of samples that are identified by QR Code, or Dynamic Non-fungible Token (dNFT); and c. archiving laboratory results that are time-stamped and secured by blockchain, and centrally archived, wherein the cannabis plant material is extracted within the self-contained sample capture unit. A method of measuring, scoring and/or ranking receptor stimulation by cannabis or hemp strains by employing genetic diagnostic testing on a seed or a plant sample provided by: a. a genetic diagnostic test resulting in the establishment of a genetic control with a test requiring a minimum of 30 samples, with results indicating a confidence level of (≥95%) of the genome map and/or identification of genetic markers indicating stimulation of one or more physical receptors, as well as particular SNPs of interest for metabolizing enzymes in which the scoring system works in sections of an algorithm, wherein the algorithm components are: selectivity of compounds produced and extracted from a plant sample with biological receptors based on genetic identification;
88209.413709 b. genetic diagnostic testing resulting in scoring of the potency of the physical receptor stimulation of the cannabis or hemp; and c. genetic traceability, diagnostic test and/or tests to confirm the genetic identification throughout the supply chain post cultivation with confirmation of the genetic identity of the cannabis or hemp via extraction, processing, or manufacturing; and are d. uniquely identified by a Dynamic Non-fungible Token (dNFT); and e. a decentralized laboratory result is time-stamped and secured by blockchain analysis, and can be centrally archived. A computer-implemented method for grouping genetic diagnostic results from one or more laboratory systems, wherein satellite laboratory data is transferred and centrally processed and stored, wherein the transfer of genetic diagnostic results is secured and time-stamped using blockchain technology, wherein a centralized data repository verifies blockchain contract transactions, then translates, normalizes, scores, and/or ranks, genetic diagnostic results before storing the data in a centralized data repository, wherein a. a genetic diagnostic test confirms the genetic match between 30 samples, with results indicating a confidence level of (≥95%) and b. genetic diagnostic testing resulting in the scoring of the potency of the physical receptor stimulation of the cannabis or hemp seed or cultivation. A computer-implemented method for accepting and genetically matching physical genetic diagnostic samples to virtual genetic diagnostic results remotely collected and stored in a centralized data repository, wherein once matched, genetic diagnostic results are tested against baseline
88209.413709 control assays, including results from a plurality of assays detailing the stimulation of physical receptors, wherein genetic diagnostic results are compared to one or more control assays with each entry entered into the centralized data repository represents one or more receptor categories where an established control sample will be used for anchoring baseline measurements to contrast samples for validation, including: a. a step for categorizing Cannabis and or hemp strains by the number of receptors and which receptors they stimulate; b. a step for categorizing Cannabis and or hemp strains by the receptor’s stimulation potency including affinity, selectivity and/or efficacy at particular receptors; and c. a step for categorizing the fidelity and presence of particular metabolic enzymes of interest and in what particular ratios and expression efficiency. A method of grouping cannabis or hemp strains by genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, and/or the comparative ranking against one or more strains stimulating the same receptor, wherein a. one or more genetic diagnostic tests indicating a confidence level of ≥95% of the genome map and identification of genetic markers indicating stimulation of one or more physical receptors indicating Clonership are utilized; and/or b. a genetic diagnostic test resulting in the measurement of the potency of the physical receptor including one or more of affinity, selectivity and/or efficacy at a particular receptor; and/or
88209.413709 c. a method of ranking of the potency of the physical receptor stimulation against one or more genetic strains stimulating the same receptor; and/or d. a method of ranking of the potency of the physical receptor stimulation against one or more genetic strains stimulating the same receptor in addition to a comparison of stimulation levels for each receptor. Satellite Laboratories sending genetic diagnostic results to a centralized data repository using a blockchain-based decentralized satellite system portal, wherein executing blockchain contracts or genetic diagnostic results are mapped to at least one receptor assay data set in the centralized data repository’s assay engine and/or a resolver module, the centralized data repository having the genetic diagnostic results associated with at least one receptor or more data sets used to map the genetic diagnostic results, the method comprising: a. receiving a genetic diagnostic result from the satellite laboratory workstation via the decentralized satellite system portal, wherein the result is associated with a blockchain contract interface code provided by the centralized data repository; and/or b. searching blockchain contracts within the centralized data repository for the assay results, wherein the genetic diagnostic results are compared to one or more assay results associated with one or more physical receptors. A method for modifying the content of a centralized data repository by a decentralized satellite system, the method comprising: a. determining a current representation of current physical location data stored in the centralized data repository;
88209.413709 b. altering the decentralized satellite system’s current data representation without altering the physical receptor data in the centralized data repository; c. receiving input from the decentralized satellite system that identifies a new representation for the current physical location data; d. modifying the current representation to the new representation without affecting a receptor identifier associated with the current representation; and e. storing the new representation to the centralized data repository. A method for accessing verified results of a centralized data repository by remote users, the method comprising: a. accessing a current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and/or hemp strains by receptors; b. accessing the current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and/or hemp strains by the receptors stimulation potency, including but not limited to affinity, selectivity and/or efficacy at tested receptors; and c. accessing the current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and/or hemp strains by the receptors stimulation potency ranking, wherein representations are limited to one source of genetic diagnostic results; and/or genetic diagnostic results are limited to one genetic source.
88209.413709 In a system including a centralized data repository for mapping genetic diagnostic results in addition to in vitro pharmacological results including composition of matter and target of activity, received from a decentralized satellite system for storage in a centralized data repository, resulting in a method for mapping representations of laboratory data genetic diagnostic results to the centralized data repository, wherein the method comprises: a. receiving a current representation identified by the decentralized satellite system; b. searching the centralized data repository for the current representation; c. searching the centralized data repository for the current ranking and scoring of genetic diagnostic results; d. searching the centralized data repository receptors stimulation potency, including but not limited to affinity, selectivity and efficacy at tested receptors ; e. searching centralized data repository of enzymes and isoforms of enzymes of interest; f. receiving instructions from decentralized satellite system; g. managing the current representation in accordance with the receive; and h. instructions, wherein the current representation is mapped to the centralized data repository. A method of creating fractional dNFTs (dynamic Non-Fungible Token) to track and manage more than one owner of a genetic profile comprising a. submitting parentage ownership proof; b. creating and deploying a smart contract; c. assigning fractional ownership by shares; d. entering the smart contract address;
88209.413709 e. entering an image of a QR code of a dNFT; f. entering metadata identifying genetic parentage name, time-stamp within the system, parentage fractional ownership, and/or reference numbers; or g. entering metadata identifying genetic parentage name, time-stamp within the system, parentage ownership, ownership status, and/or reference numbers; or h. entering metadata identifying the genetic parentage profile, containing on-chain data that includes Clonership identification via an informatic approach of genetic materials; or i. entering metadata identifying key enzymes and genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including that of any and all isoforms of enzymes of interest; j. entering metadata identifying particular receptor screening results; k. entering metadata related to the ration of identifying key enzymes related to the production of key compounds of interest (meroterpenoids); l. entering metadata referencing dynamic comparative data comprising other parentage profiles and genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; off-chain data referencing dynamic comparative data comprising ratio of compounds presence compared to known reference samples as well as selectivity of receptors stimulated;
88209.413709 m. entering metadata referencing ownership status, including exclusive or non-exclusive ownership status derived from a fractional dNFT; n. entering metadata referencing the scoring and ranking of receptor stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; o. entering metadata referencing location restrictions; p. entering metadata referencing various regulatory approvals and/or clinical data; q. entering metadata referencing, ownership web address and/or contact information; r. deploying the smart contract to the blockchain; s. adding the dNFT to the dNFT vault; t. allowing the potential transfer of ownership; and/or, u. achieving consensus over the ledger’s state. A method of creating Dynamic Non-Fungible Tokens (dNFTs) to track and manage one owner of a genetic profile comprising a. deploying a smart contract; b. entering the smart contract address; c. entering an image of a QR code of a dNFT; d. entering metadata identifying genetic parentage name, time-stamp within the system, divided parentage ownership, and/or reference numbers; e. entering metadata identifying genetic parentage name, time-stamp within the system, parentage ownership, ownership status, and/or reference numbers;
88209.413709 f. entering metadata identifying the genetic parentage profile, containing on-chain data that includes Clonership identification via an informatic approach of genetic materials; g. entering metadata identifying key enzymes and genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including that of any and all isoforms of enzymes of interest; h. entering metadata identifying particular receptor screening results; i. r entering metadata related to the ratio of identified key enzymes related to the production of key compounds of interest (meroterpenoids); j. entering metadata referencing dynamic comparative data comprising other parentage profiles and genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; off-chain data referencing dynamic comparative data comprising ratio of compounds presence compared to known reference samples as well as selectivity of receptors stimulated; k. entering metadata referencing ownership status, including exclusive or non-exclusive ownership status derived from a fractional dNFT; l. entering metadata referencing the scoring and ranking of receptor stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; m. entering metadata referencing location restrictions;
88209.413709 n. entering metadata referencing various regulatory approvals and/or clinical data; o. entering metadata referencing, ownership web address and/or contact information; p. deploying the smart contract to the blockchain; q. adding the dNFT to the dNFT vault; r. allowing the potential transfer of ownership; and, s. achieving consensus over the ledger’s state. 13. A system comprising a laboratory, central data repository, and Dynamic Non-Fungible Tokens (dNFTs) linked to a specific genetic parentage to track and manage verification, purchase, and/or payment for hemp and/or cannabis within a supply chain, as well as tracking payments from licensees to licensors, and/or payments to a government authority, the system including a. accepting a shipment of cannabis or hemp into an inventory management system by scanning an attached dNFT; b. testing a sample of the shipment to verify it matches the purported parentage within the dNFT; c. accepting payment for a shipment; d. verifying a sample matches a requested genetic parentage within the dNFT; e. releasing the funds to the seller and the product to the buyer; f. releasing funds to a licensor; and g. releasing funds to a government authority. [0139] Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the
88209.413709 invention. All references cited throughout the specification, including those in the background, are incorporated herein in their entirety. Those skilled in the art will recognize, or be able to ascertain, using no more than routine experimentation, many equivalents to specific embodiments of the invention described specifically herein. Such equivalents are intended to be encompassed in the scope of the following claims.
Claims
88209.413709 CLAIMS What is claimed is: 1. An apparatus for the collection and transportation of genetic material comprising: a self-contained sample capture and processing unit for the extraction and isolation of compounds of interest within cannabis plants, wherein the self-contained sample capture apparatus provides for a. extraction of a cannabis plant source from a cannabis source within the self-contained sample capture apparatus suitable for transportation of genetic material; b. qualification and quantification of chemical compounds of interest (meroterpenoids) identified from the cannabis plant source within the self-contained sample capture apparatus; c. a receptor screening assay is performed with clinical data read- outs from the cannabis plant source within the self-contained sample capture apparatus, wherein cannabis source is extracted to provide the cannabis plant source; and d. the extracted cannabis plant source is identified by QR Code, or Dynamic Non-fungible Token (dNFT) including selectivity, affinity and/or efficacy at receptors of interest. 2. A self-contained sample capture and processing unit that provides extraction and isolation of specific genetic testing for key genetic markers within cannabis plant material including entire genome mapping, wherein the self-contained sample capture and processing unit provides: a. key enzymes of genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including identification of isoforms of enzymes of interest;
88209.413709 b. clonership identification via an informatic approach of genetic materials including the identification of parent, clone and/or hybrid strain of samples that are identified by QR Code, or Dynamic Non-fungible Token (dNFT); and c. archiving laboratory results that are time-stamped and secured by blockchain, and centrally archived, wherein the cannabis plant material is extracted within the self-contained sample capture unit. 3. A method of measuring, scoring and/or ranking receptor stimulation by cannabis or hemp strains by employing genetic diagnostic testing on a seed or a plant sample provided by: a. a genetic diagnostic test resulting in the establishment of a genetic control with a test requiring a minimum of 30 samples, with results indicating a confidence level of (≥95%) of the genome map and/or identification of genetic markers indicating stimulation of one or more physical receptors, as well as particular SNPs of interest for metabolizing enzymes in which the scoring system works in sections of an algorithm, wherein the algorithm components are: selectivity of compounds produced and extracted from a plant sample with biological receptors based on genetic identification; b. genetic diagnostic testing resulting in scoring of the potency of the physical receptor stimulation of the cannabis or hemp; and c. genetic traceability, diagnostic test and/or tests to confirm the genetic identification throughout the supply chain post cultivation with confirmation of the genetic identity of the cannabis or hemp via extraction, processing, or manufacturing; and are d. uniquely identified by a Dynamic Non-fungible Token (dNFT); and
88209.413709 e. a decentralized laboratory result is time-stamped and secured by blockchain analysis, and can be centrally archived. 4. A computer-implemented method for grouping genetic diagnostic results from one or more laboratory systems, wherein satellite laboratory data is transferred and centrally processed and stored, wherein the transfer of genetic diagnostic results is secured and time-stamped using blockchain technology, wherein a centralized data repository verifies blockchain contract transactions, then translates, normalizes, scores, and/or ranks, genetic diagnostic results before storing the data in a centralized data repository, wherein a. a genetic diagnostic test confirms the genetic match between 30 samples, with results indicating a confidence level of (≥95%) and b. genetic diagnostic testing resulting in the scoring of the potency of the physical receptor stimulation of the cannabis or hemp seed or cultivation. 5. A computer-implemented method for accepting and genetically matching physical genetic diagnostic samples to virtual genetic diagnostic results remotely collected and stored in a centralized data repository, wherein once matched, genetic diagnostic results are tested against baseline control assays, including results from a plurality of assays detailing the stimulation of physical receptors, wherein genetic diagnostic results are compared to one or more control assays with each entry entered into the centralized data repository represents one or more receptor categories where an established control sample will be used for anchoring baseline measurements to contrast samples for validation, including: a. a step for categorizing Cannabis and or hemp strains by the number of receptors and which receptors they stimulate;
88209.413709 b. a step for categorizing Cannabis and or hemp strains by the receptor’s stimulation potency including affinity, selectivity and/or efficacy at particular receptors; and c. a step for categorizing the fidelity and presence of particular metabolic enzymes of interest and in what particular ratios and expression efficiency. 6. A method of grouping cannabis or hemp strains by genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, and/or the comparative ranking against one or more strains stimulating the same receptor, wherein a. one or more genetic diagnostic tests indicating a confidence level of ≥95% of the genome map and identification of genetic markers indicating stimulation of one or more physical receptors indicating Clonership are utilized; and/or b. a genetic diagnostic test resulting in the measurement of the potency of the physical receptor including one or more of affinity, selectivity and/or efficacy at a particular receptor; and/or c. a method of ranking of the potency of the physical receptor stimulation against one or more genetic strains stimulating the same receptor; and/or d. a method of ranking of the potency of the physical receptor stimulation against one or more genetic strains stimulating the same receptor in addition to a comparison of stimulation levels for each receptor. 7. Satellite Laboratories sending genetic diagnostic results to a centralized data repository using a blockchain-based decentralized satellite system portal, wherein executing blockchain contracts or genetic diagnostic results are mapped to at least one receptor assay data set in the
88209.413709 centralized data repository’s assay engine and/or a resolver module, the centralized data repository having the genetic diagnostic results associated with at least one receptor or more data sets used to map the genetic diagnostic results, the method comprising: a. receiving a genetic diagnostic result from the satellite laboratory workstation via the decentralized satellite system portal, wherein the result is associated with a blockchain contract interface code provided by the centralized data repository; and/or b. searching blockchain contracts within the centralized data repository for the assay results, wherein the genetic diagnostic results are compared to one or more assay results associated with one or more physical receptors. 8. A method for modifying the content of a centralized data repository by a decentralized satellite system, the method comprising: a. determining a current representation of current physical location data stored in the centralized data repository; b. altering the decentralized satellite system’s current data representation without altering the physical receptor data in the centralized data repository; c. receiving input from the decentralized satellite system that identifies a new representation for the current physical location data; d. modifying the current representation to the new representation without affecting a receptor identifier associated with the current representation; and e. storing the new representation to the centralized data repository. 9. A method for accessing verified results of a centralized data repository by remote users, the method comprising:
88209.413709 a. accessing a current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and/or hemp strains by receptors; b. accessing the current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and/or hemp strains by the receptors stimulation potency, including but not limited to affinity, selectivity and/or efficacy at tested receptors; and c. accessing the current representation of blockchain contracts stored in the centralized data repository indicating the current ranking of cannabis and/or hemp strains by the receptors stimulation potency ranking, wherein representations are limited to one source of genetic diagnostic results; and/or genetic diagnostic results are limited to one genetic source. 10. In a system including a centralized data repository for mapping genetic diagnostic results in addition to in vitro pharmacological results including composition of matter and target of activity, received from a decentralized satellite system for storage in a centralized data repository, resulting in a method for mapping representations of laboratory data genetic diagnostic results to the centralized data repository, wherein the method comprises: a. receiving a current representation identified by the decentralized satellite system; b. searching the centralized data repository for the current representation; c. searching the centralized data repository for the current ranking and scoring of genetic diagnostic results; d. searching the centralized data repository receptors stimulation potency, including but not limited to affinity, selectivity and efficacy at tested receptors ;
88209.413709 e. searching centralized data repository of enzymes and isoforms of enzymes of interest; f. receiving instructions from decentralized satellite system; g. managing the current representation in accordance with the receive; and h. instructions, wherein the current representation is mapped to the centralized data repository. 11. A method of creating fractional Dynamic Non-Fungible Tokens (dNFTs) to track and manage more than one owner of a genetic profile comprising a. submitting parentage ownership proof; b. creating and deploying a smart contract; c. assigning fractional ownership by shares; d. entering the smart contract address; e. entering an image of a dNFT; f. entering metadata identifying genetic parentage name, time-stamp within the system, parentage fractional ownership, and/or reference numbers; or g. entering metadata identifying genetic parentage name, time-stamp within the system, parentage ownership, ownership status, and/or reference numbers; or h. entering metadata identifying the genetic parentage profile, containing on-chain data that includes Clonership identification via an informatic approach of genetic materials; or i. entering metadata identifying key enzymes and genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including that of any and all isoforms of enzymes of interest; j. entering metadata identifying particular receptor screening results;
88209.413709 k. entering metadata related to the ration of identifying key enzymes related to the production of key compounds of interest (meroterpenoids); l. entering metadata referencing dynamic comparative data comprising other parentage profiles and genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; off-chain data referencing dynamic comparative data comprising ratio of compounds presence compared to known reference samples as well as selectivity of receptors stimulated; m. entering metadata referencing ownership status, including exclusive or non-exclusive ownership status derived from a fractional dNFT; n. entering metadata referencing the scoring and ranking of receptor stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; o. entering metadata referencing location restrictions; p. entering metadata referencing various regulatory approvals and/or clinical data; q. entering metadata referencing, ownership web address and/or contact information; r. deploying the smart contract to the blockchain; s. adding the dNFT to the dNFT vault; t. allowing the potential transfer of ownership; and/or, u. achieving consensus over the ledger’s state. 12. A method of creating Dynamic Non-Fungible Tokens (dNFTs) to track and manage one owner of a genetic profile comprising a. deploying a smart contract;
88209.413709 b. entering the smart contract address; c. entering an image of a dNFT; d. entering metadata identifying genetic parentage name, time-stamp within the system, divided parentage ownership, and/or reference numbers; e. entering metadata identifying genetic parentage name, time-stamp within the system, parentage ownership, ownership status, and/or reference numbers; f. entering metadata identifying the genetic parentage profile, containing on-chain data that includes Clonership identification via an informatic approach of genetic materials; g. entering metadata identifying key enzymes and genetic sequences in the cannabis plants that produce chemical compounds of interest (meroterpenoids), including that of any and all isoforms of enzymes of interest; h. entering metadata identifying particular receptor screening results; i. r entering metadata related to the ratio of identified key enzymes related to the production of key compounds of interest (meroterpenoids); j. entering metadata referencing dynamic comparative data comprising other parentage profiles and genetic diagnostic results, their stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; off-chain data referencing dynamic comparative data comprising ratio of compounds presence compared to known reference samples as well as selectivity of receptors stimulated; k. entering metadata referencing ownership status, including exclusive or non-exclusive ownership status derived from a fractional dNFT;
88209.413709 l. entering metadata referencing the scoring and ranking of receptor stimulation of various receptors, and a scoring of the potency of their effect on specific receptors, with a comparative ranking against one or more strains stimulating the same receptor; m. entering metadata referencing location restrictions; n. entering metadata referencing various regulatory approvals and/or clinical data; o. entering metadata referencing, ownership web address and/or contact information; p. deploying the smart contract to the blockchain; q. adding the dNFT to the dNFT vault; r. allowing the potential transfer of ownership; and, s. achieving consensus over the ledger’s state. 13. A system comprising a laboratory, central data repository, and Dynamic Non-Fungible Tokens (dNFTs) linked to a specific genetic parentage to track and manage verification, purchase, and/or payment for hemp and/or cannabis within a supply chain, as well as tracking payments from licensees to licensors, and/or payments to a government authority, the system including a. accepting a shipment of cannabis or hemp into an inventory management system by scanning an attached dNFT; b. testing a sample of the shipment to verify it matches the purported parentage within the dNFT; c. accepting payment for a shipment; d. verifying a sample matches a requested genetic parentage within the dNFT; e. releasing the funds to the seller and the product to the buyer; f. releasing funds to a licensor; and g. releasing funds to a government authority.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
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| US20050227370A1 (en) * | 2004-03-08 | 2005-10-13 | Ramel Urs A | Body fluid analyte meter & cartridge system for performing combined general chemical and specific binding assays |
| US20170059536A1 (en) * | 2015-09-01 | 2017-03-02 | Orange Photonics, Inc. | Cannabinoid concentration analyzer and method |
| US20190256888A1 (en) * | 2013-06-12 | 2019-08-22 | The General Hospital Corporation | Methods, kits, and systems for multiplexed detection of target molecules and uses thereof |
| WO2022101398A1 (en) * | 2020-11-13 | 2022-05-19 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e. V. | Authenticatable sample collection kit for plant sample collection, and use thereof |
| US20230037728A1 (en) * | 2021-08-09 | 2023-02-09 | Allele Group LLC | Software, methods, and systems for blockchain-recorded transactions of real-world assets |
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- 2024-08-27 WO PCT/US2024/044062 patent/WO2025049491A1/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050227370A1 (en) * | 2004-03-08 | 2005-10-13 | Ramel Urs A | Body fluid analyte meter & cartridge system for performing combined general chemical and specific binding assays |
| US20190256888A1 (en) * | 2013-06-12 | 2019-08-22 | The General Hospital Corporation | Methods, kits, and systems for multiplexed detection of target molecules and uses thereof |
| US20170059536A1 (en) * | 2015-09-01 | 2017-03-02 | Orange Photonics, Inc. | Cannabinoid concentration analyzer and method |
| WO2022101398A1 (en) * | 2020-11-13 | 2022-05-19 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e. V. | Authenticatable sample collection kit for plant sample collection, and use thereof |
| US20230037728A1 (en) * | 2021-08-09 | 2023-02-09 | Allele Group LLC | Software, methods, and systems for blockchain-recorded transactions of real-world assets |
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