DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed November 5, 2025 has been entered. Claims 4-8 remain pending in the application.
Claim Objections
Claims 5-8 are objected to because of the following informalities:
In claims 5-8, “The patient health record system of claim 1” should read --The patient health record system of claim 4--.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 4-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Under the Step 1 of the Section 101 analysis, Claims 4-8 are drawn to a system which is within the four statutory categories (i.e. a machine).
Since the claims are directed toward statutory categories, it must be determined if the claims are directed towards a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea). Based on consideration of all of the relevant factors with respect to the claim as a whole, claims 4-8 are determined to be directed to an abstract idea. The rationale for this determination is explained below:
Regarding Claim 4:
Claim 4 is drawn to an abstract idea without significantly more. The claims recite “a patient health module to manage health information about a plurality of patients, including a specific patient, by issuing a first NFT of a series of NFTs, wherein a smart contract is bound to the series of NFTs to apply rules for when to immutably record patient data on a blockchain, wherein a patient private key/wallet address pair is associated with the blockchain; a hospital module to aggregate health information for the plurality of patients, including the specific patient, wherein a first smart contract of the first NFT automatically identifies health events for recordation, including identifying a health event in a series of health events associated with the specific patient; an NFT processing module coordinates, over the data communication network, with an NFT engine for recording the health care events on the blockchain, including recording the health event of the series of health events associated with the specific patient as an NFT of a series of NFTs, on the blockchain, using the patient private key/wallet address pair associated with the blockchain; and using an AI agent to classify patient histories based on parameters identified in the clinical trial and create one or more cohorts of patients from the plurality of patients, by matching the parameters to the series of NFTs on the blockchain.”
Under the Step 2A Prong One, the limitations, as underlined above, are processes that, under its broadest reasonable interpretation, cover Mental Processes such as concepts performed in the human mind (including an observation, evaluation, judgment, opinion). For example, but for the “module”, “NFT”, “smart contract”, “blockchain”, “private key/wallet address pairs”, “automatically”, “data communication network”, “NFT engine”, and “AI agent” language, the underlined limitations in the context of this claim encompass the mental processes. The series of steps belong to a typical evaluation, judgment, or opinion, because data or information and a piece of token information can be created mentally by people, and matching or classifying data such as patient histories also can be performed mentally by people.
Under the Step 2A Prong Two, this judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements – “A patient health record system, on a data communication network, for creating patient cohorts from a blockchain for a clinical trial, the patient health record system comprising: a processor; a network interface communicatively coupled to the processor and to the data communication network; and a memory, communicatively coupled to the processor and storing source code executed by the processor, comprising:”, “module”, “NFT”, “smart contract”, “blockchain”, “private key/wallet address pairs”, “automatically”, “data communication network”, “NFT engine”, and “AI agent”. The additional elements are recited at a high-level of generality (i.e., performing generic functions of an interaction) such that it amounts no more than mere instructions to apply the exception using a generic computer component, merely implementing an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea. Additionally, regarding the specification and claims, there is no improvement in the functioning of a computer or an improvement to other technology or technical field present, there is no applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition present, there is no implementing the judicial exception with or using the judicial exception in conjunction with a particular machine or manufacture that is integral to the claim present, there is no effecting a transformation or reduction of a particular article to a different state or thing present, and there is no applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment present such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Accordingly, these additional elements, individually or in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Under the Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements in the process amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims are not patent eligible.
Regarding Claims 5-8:
Dependent claim 5 only further elaborates the abstract idea and do not recite additional elements.
Dependent claims 6-8 include additional limitations, for example, “NFTs” (Claim 6); “NFT”, “ERC998”, “ERC6551”, and “ERC4337” (Claim 7); and “wallet”, “private key”, and “NFT” (Claim 8), but none of these limitations are deemed significantly more than the abstract idea because, as stated above, they require no more than generic computer structures or signals to be executed, and do not recite any Improvements to the functioning of a computer, or Improvements to any other technology or technical field.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation or implementing the judicial exception on a generic computer.
Therefore, whether taken individually or as an ordered combination, claims 5-8 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cordonnier (US 20230268040 A1) in view of Gross (US 20250131994 A1).
Regarding Claim 4, Cordonnier teaches A patient health record system, on a data communication network, for creating patient [cohorts] from a blockchain for a clinical trial, the patient health record system comprising: a processor; a network interface communicatively coupled to the processor and to the data communication network; and a memory, communicatively coupled to the processor and storing source code executed by the processor, comprising: (Cordonnier: Abstract; Paragraph(s) 0015, 0020, 0054, 0083, 0088, 0104):
a patient health module to manage health information about a plurality of patients, including a specific patient, by issuing a first NFT of a series of NFTs, wherein a smart contract is bound to the series of NFTs to apply rules for when to immutably record patient data on a blockchain, wherein a patient private key/wallet address pair is associated with the blockchain (Cordonnier: Paragraph(s) 0028-0029, 0037-0038, 0046, 0050, 0113, 0115-0116, 0020-0021, 0102 teach(es) System can include one or more digital filing cabinets that can contain, without limitation, one or more electronic health records (EHRs), EMRs, patient information, digital wallets (e.g., signed messages, keys, cryptocurrency, tokens, credit cards, payment information, etc.), and other healthcare data; NFTs can provide verification of digital healthcare data by authenticating access credentials (e.g., public and private keys), eliminating tampering of data (data integrity), and providing a source of truth for a patient’s health record; The healthcare management system can create a digital key for each user (e.g., patient, healthcare provider, insurance provider, family member, etc.) and rules (e.g., smart contract) regarding authorization to access the healthcare data; process converts the healthcare data into NFTs. Process can generate a digital key (private and public) to access each NFT and a digital wallet(s)); a hospital module to aggregate health information for the plurality of patients, including the specific patient, wherein a first smart contract of the first NFT automatically identifies health events for recordation, including identifying a health event in a series of health events associated with the specific patient (Cordonnier: Paragraph(s) 0020-0021, 0102, 0115-0116, 0049 teach(es) The healthcare management system can create a digital key for each user (e.g., patient, healthcare provider, insurance provider, family member, etc.) and rules (e.g., smart contract) regarding authorization to access the healthcare data; process converts the healthcare data into NFTs. Process can generate a digital key (private and public) to access each NFT and a digital wallet(s); The healthcare events can include imaging, diagnosis, treatment, and/or outcomes and event data that can be encoded in the blockchain); and an NFT processing module coordinates, over the data communication network, with an NFT engine for recording the health care events on the blockchain, including recording the health event of the series of health events associated with the specific patient as an NFT of a series of NFTs, on the blockchain, using the patient private key/wallet address pair associated with the blockchain (Cordonnier: Paragraph(s) 0020, 0028-0029 teach(es) The healthcare management system can use blockchain technology to convert healthcare data (e.g., patient information, surgery details, imaging studies, EMRs, implant information, and/or additional patient related information) into NFTs; The healthcare management system can create a digital key for each user (e.g., patient, healthcare provider, insurance provider, family member, etc.) and rules (e.g., smart contract) regarding authorization to access the healthcare data; since the NFT(s) is digitally stored on the blockchain, the NFT(s) is immutable (e.g., can’t be changed) and distributed (e.g., output is validated by the blockchain network), making it difficult for a nefarious actor to access the healthcare data; System can include one or more digital filing cabinets that can contain, without limitation, one or more electronic health records (EHRs), EMRs, patient information, digital wallets (e.g., signed messages, keys, cryptocurrency, tokens, credit cards, payment information, etc.), and other healthcare data); and using an AI agent to classify patient histories based on parameters identified in the clinical trial and create one or more [cohorts] of patients from the plurality of patients, by matching the parameters to the series of NFTs on the blockchain (Cordonnier: Paragraph(s) 0100-0101, 0104, 0109 teach(es) the NFT module can analyze data, identify data based on one or more rules, group identified data, and convert grouped data to NFT(s); The healthcare data can be used to generate metadata of the NFT; The NFT module can also include a machine learning engine trained to identify, categorize, group, and/or convert data to NFT’s; The EMRs can include patient healthcare data (e.g., images, scans, documents, etc.), demographic information about the patient, identifying information of the patient, historical patient treatment data, metrics, etc.).
However, Cordonnier does not explicitly teach cohorts.
Gross from same or similar field of endeavor teaches cohorts (Gross: Paragraph(s) 0045-0046, 0078, 0094, 0104, 0106, 0110 teach(es) patients may seek out and connect with other patients in a cohort of patient-users having common features (e.g., background information, treatment, disease), allowing the patients in the cohort to leverage similar sub-tokens as a collective).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Cordonnier to incorporate the teachings of Gross for cohorts.
There is motivation to combine Gross into Cordonnier because Gross’s teachings of cohorts would facilitate patient consent for the particular specimen when the server executes a smart contract that transparently implements a voting process for nodes associated with each NFT of a cohort of NFTs sharing common attributes (Gross: Paragraph(s) 0110).
Regarding Claim 5, the combination of Cordonnier and Gross teaches all the limitations of claim 4 above; and Cordonnier further teaches wherein the parameters comprise one or more of symptoms, responses, and dosage (Cordonnier: Paragraph(s) 0114 teach(es) The healthcare data (e.g., EMRs) can include data representative of the patient’s condition, anatomy, pathology, symptoms, medical history, preferences, and/or any other information or parameters relevant to the patient).
Regarding Claim 6, the combination of Cordonnier and Gross teaches all the limitations of claim 4 above; and Cordonnier further teaches wherein each of the first series of NFTs represents a non-overlapping interval of time (Cordonnier: Paragraph(s) 0049 teach(es) loading across the implant can be tracked over a period of time).
Regarding Claim 8, the combination of Cordonnier and Gross teaches all the limitations of claim 4 above; and Cordonnier further teaches wherein a first wallet is created to store a private key associated with the fist NFT (Cordonnier: Paragraph(s) 0113 teach(es) The NFTs, crypto coins, and digital keys can be stored in a digital wallet).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cordonnier (US 20230268040 A1) in view of Gross (US 20250131994 A1), as applied to claim 4 above, and in further view of Witchey (US 20240338680 A1).
Regarding Claim 7, the combination of Cordonnier and Gross teaches all the limitations of claim 4 above; however the combination does not explicitly teach wherein NFT data is recorded according to at least one of: ERC998, ERC6551 and ERC4337.
Witchey from same or similar field of endeavor teaches wherein NFT data is recorded according to at least one of: ERC998, ERC6551 and ERC4337 (Witchey: Paragraph(s) 0030 teach(es) ERC-998 defines interfaces for creating tokens comprising sub-tokens and vice versa).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of the combination of Cordonnier and Gross to incorporate the teachings of Witchey for wherein NFT data is recorded according to at least one of: ERC998, ERC6551 and ERC4337.
There is motivation to combine Witchey into the combination of Cordonnier and Gross because Witchey’s teachings of ERC998 would facilitate generating NFTs (Witchey: Paragraph(s) 0030).
Response to Arguments
Applicant's arguments filed November 5, 2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument under Claim Rejections - 35 USC § 101 that “New claim 4, however, processes data by setting up series of NFTs to collect events and generating cohorts from the information. As governed by smart contracts, health events trigger immutable recordation based records for parameters of a clinical trial. Then AI agents are able to generate cohorts. Clearly, these are not mental processes, as they are technical solutions,” examiner respectfully argues that processing data, recording data, and generating cohorts of patients, as recited in the claims, can be performed manually or mentally by people, and in addition that the additional elements such as NFTs, smart contracts, immutable recordation, and AI agents are recited without technical details and contexts. The claims are not patent eligible.
Regarding applicant’s argument under Claim Rejections - 35 USC § 103 that “Claim 4 recites a first smart contract of the first NFT identifies health events for recordation, but Cordonnier fails to teach the same,” examiner respectfully argues that Cordonnier teaches that the healthcare management system can create a digital key for each user and rules (e.g., smart contract) regarding authorization to access the healthcare data (Cordonnier: Paragraph(s) 0020-0021, 0102, 0115-0116, 0049).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kruger (US 20220406419 A1) teaches System And Methods For Creating Non-Fungible Tokens, including NFT, medical record, secure cryptocurrency wallet comprising a private key of the first patient, and smart contract.
Gardina (US 20220139566 A1) teaches DISTRIBUTED MEDICAL TESTING FRAMEWORK, including artificial intelligence, NFT, clinical trials, medical test, and smart contract.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CLAY C LEE/Primary Examiner, Art Unit 3699