DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
The following claim(s) is/are pending in this office action: 77-96
The following claim(s) is/are amended: 77, 87-89, 92, 96
The following claim(s) is/are new: -
The following claim(s) is/are cancelled: 1-76
Claim(s) 77-88 and 90-96 is/are rejected. Claim 89 is objected to. This rejection is FINAL.
Previous Rejections Withdrawn
The 35 USC 112(b) rejection to claim(s) 88, 96 is/are withdrawn based on the amendment.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 11/7/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered if signed and initialed by the Examiner.
Response to Arguments
Applicant’s arguments filed in the amendment filed 11/7/2025, have been fully considered but are moot in view of new grounds of rejection. The reasons set forth below.
Applicant’s Invention as Claimed
Claim Objections
Claim 89 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections
Claim Rejections - 35 USC § 103
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 of this title, 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.
Claims 77-88 and 90-96 are rejected under 35 U.S.C. 103 as being unpatentable over Witchey (US Pub. 2021/0166792) in view of Lee (US Pub. 2023/0214792) and further in view of Wall Warner (US Pub. 2017/0316162).
With respect to Claim 77, Witchey teaches a computer-implemented method for managing data for a blockchain, the method comprising: receiving, by a computer from a client device, patient personal data for a patient (para. 35-36; biological sample is extracted from patient. Paras. 47-49; sample is recorded in a tracking database such as a blockchain and tracked over the course of its lifecycle. Para. 52, 74, 104; information on sample includes patient id and sample id. para. 74; initial block of data includes patient data such as name and social security number.)
responsive to the computer validating the validation data of a threshold number of validation inputs from the set of one or more validation inputs, generating, by the computer, a patient token as a non-fungible token on a blockchain, the patient token representing the patient personal data and including a unique patient token identifier; (Para. 36, 74, 78; genesis block includes a block token that is generated as a function of the data in the block. The data in the block includes patient data includes patient name, social security number, etc. as well as a patient identifier. Para. 81; block token generated with UUID functions. See also Lee, para. 22; Dynamic token identifying a person. Para. 379; non-fungible token identifying a unique thing.)
receiving, by the computer from the client device, specimen data for a specimen associated with the patient, the specimen data including a unique specimen identifier based at least in part on the patient personal data; (para. 77; block includes intrinsic data of the sample such as descriptors or intrinsic properties. Para. 83; intrinsic properties of a tissue sample are used as a foundation of a new block. Para. 52, 74, 104; information on sample includes patient id and sample id.)
and an encrypted version of the portion of the patient personal data. (para. 99; stored private data can be encrypted)
But Witchey does not explicitly teach a sub-token.
Lee, however, does teach and a set of one or more validating inputs having validation data associated with one or more corresponding validating users; (paras. 272-273; certificate that attests to authority to issue tokens. Para. 279; token verification via certificate check.)
and generating, by the computer, a specimen sub-token of the blockchain representing the specimen data using at least a portion of the patient personal data of the patient token, the specimen sub-token including the unique specimen identifier, (First see Witchey, paras. 54-56, 74-75; sample state data is an object that may be packaged as a token. Para. 52, 74, 104; information on sample includes patient id and sample id. Thus, Witchey teaches creating a single token that identifies both the patient and their sample, and thus does not teach a sub-token. Then see Lee, para. 434; sub-token that applies properties to a base token. System may generate a sub-token that includes the results and time of a test for a patient. Although the sub-token in Lee is generated from a healthcare monitor base token, it would have been obvious to one of ordinary skill prior to the effective filing date to generate a sub-token from the base token of the patient instead because it further identifies properties of the base token (i.e. the test describes the condition of the patient).)
a unique specimen token identifier, the unique patient token identifier, (para. 41, 341; tokens include token ids.)
It would have been obvious to one of ordinary skill prior to the effective filing date to combine the method of Witchey with the sub-token in order to manage or permit access to only a portion of data. (See Witchey, para. 99; permission of access to data. See also Lee, para. 426; each sub-token can be managed individually.)
But modified Witchey does not explicitly teach patient consent.
Wall Warner, however, does teach the one or more validating inputs including a consent validating input associated with the patient; including at least one validating input including the consent validating input from a patient device associated with the patient (paras. 8-12; patient informed consent is stored on the blockchain. Para. 42; submission devices to perform submission of patient records.)
It would have been obvious to one of ordinary skill prior to the effective filing date to combine the method of modified Witchey with the consent input to avoid legal or ethical problems. (See Wall Warner, para. 12)
With respect to Claim 78, modified Witchey teaches the method according to claim 77, and Witchey also teaches wherein the patient personal data comprises a patient unique identifier. (para. 36; patient id. para. 74; social security number)
With respect to Claim 79, modified Witchey teaches the method according to claim 77, and Lee also teaches wherein the specimen sub-token is a second non-fungible token of the blockchain. (Para. 434; subtoken derived from base token. Para. 379; non-fungible token identifying a unique thing.)
The same motivation to combine as the independent claim applies here.
With respect to Claim 80, modified Witchey teaches the method according to claim 77, and Lee also teaches wherein receiving the specimen data includes: receiving, by the computer, a second set of one or more validating inputs having the validation data associated with the one or more corresponding validating users, wherein the computer generates the specimen sub-token responsive to the computer validating the validation data of the threshold number of validation inputs from the second set of one or more validation inputs. (para. 434; sub-tokens from varying sources. See also Witchey paras. 64, 71, 84; validation of subsequent states based on previous states)
The same motivation to combine as the independent claim applies here.
With respect to Claim 81, modified Witchey teaches the method according to claim 77, and Lee also teaches further comprising, for each validation input, identifying, by the computer, a valid cryptographic certificate corresponding to the validation data of the validation input according to a certificate authority. (para. 9, 14, 21; root authority of a certificate. Para. 279; token verification via certificate check.)
The same motivation to combine as the independent claim applies here.
With respect to Claim 82, modified Witchey teaches the method according to claim 77, and Witchey also teaches wherein the patient token or the specimen sub-token includes at least one of: text data, media data, and a pointer for a remote non-transitory storage. (para. 51; digital image, which is media data. Para. 36-37; intrinsic features such as descriptions of shape, which is text. Para. 88; URL pointer to specimen data.)
With respect to Claim 83, modified Witchey teaches the method according to claim 82, and Witchey also teaches wherein the remote non-transitory storage includes a biobank database containing at least a portion of the specimen data. (para. 45, 58; samples can be stored in a storage facility and the storage location can be identified.)
With respect to Claim 84, modified Witchey teaches the method according to claim 77, and Witchey also teaches wherein a first portion of the specimen data represented by the specimen sub-token is stored in the sub-token and a second portion of the specimen data represented by the specimen sub-token is stored in a database hosted on a non-transitory machine-readable memory. (para. 31, 36-37, 52; block stores sample id and intrinsic properties such as shape descriptor information. para. 88; block stores pointer to where slide images are stored. Thus the token data includes both first portion direct data and second portion referential or indirect data.)
With respect to Claim 85, modified Witchey teaches the method according to claim 77, and Witchey also teaches further comprising: receiving, by the computer, from a second client device treatment data for one or more treatments associated with one or more physicians; (para. 58, 65; tracking of procedure data such as surgical procedures. para. 101; tracking chain coupled to treatments.)
and generating, by the computer, a treatment sub-token representing the treatment data for a particular treatment using at least one of the patient data and the specimen data, (para. 434; sub-token that applies properties to a base token. System may generate a sub-token that includes the results and time of a test for a patient. It would have been obvious to one of ordinary skill prior to the effective filing date to generate a sub-token from a base token in order to further describe properties of the base token.)
responsive to the computer validating the validation data of the threshold number of validation inputs from a second set of one or more validation inputs. (paras. 272-273; certificate that attests to authority to issue tokens. Para. 279; token verification via certificate check.)
The same motivation to combine as the independent claim applies here.
With respect to Claim 86, modified Witchey teaches the method according to claim 77, and Witchey also teaches further comprising: obtaining, by the computer, a specimen request associated with a researcher device, the specimen request including one or more specimen attributes; querying, by the computer, the specimen data of a plurality of specimen sub-tokens using the one or more specimen attributes of the specimen request; (para. 48, 52-53; database receives search query. Para. 52; sample id used for search query. paras. 46, 62; system can be used with research. Para. 101; R&D studies.)
determining, by the computer, a cohort of one or more specimens having the specimen data satisfying the one or more specimen attributes; (para. 54; result retrieval matching query. See also para. 101; database can retrieve not only individual data but collections of similar data such as R&D cohort data.)
generating, by the computer, one or more custody updates to one or more transaction blocks of the blockchain having the patient token, the one or more custody updates corresponding to the one or more specimens of the cohort. (paras. 61, 105; update to database. para. 56; current state can include identifier of user. Para. 58; state can include geo-location data, stakeholder data, care provider data, workstation data.)
With respect to Claim 87, modified Witchey teaches the method according to claim 86, and Witchey also teaches wherein obtaining the specimen request includes receiving, by the computer, from a second client device research data associated with the specimen according to one or more identifiers in the research data. (para. 63; recall of sample information by scanning bar code. The bar code scanner is a second client device. Further, separation of parts is obvious, see MPEP 2144.)
With respect to Claim 88, modified Witchey teaches the method according to claim 86, and Lee also teaches wherein the computer obtains the specimen request from a non-transitory storage media, and wherein the computer is configured to generate the cohort at a predetermined interval using the research request stored in the storage media. (para. 763; periodic identification of tokens to track them. See also Witchey, para. 101; database can retrieve not only individual data but collections of similar data such as R&D cohort data.)
The same motivation to combine as the independent claim applies here.
With respect to Claim 90, modified Witchey teaches the method according to claim 77, and Lee also teaches further comprising updating, by the computer, sub-token inventory data associated with the patient token to include the specimen unique identifiers of the specimen sub-token. (para. 41, 341; tokens include token ids. See also Witchey, para. 88; URL pointer to specimen data. It would have been obvious to one of ordinary skill prior to the effective filing date to include the specimen sub-token identifier in the patient token in order to identify that there is additional information about the patient.)
The same motivation to combine as the independent claim applies here.
With respect to Claim 91, modified Witchey teaches the method according to claim 77, and Witchey also teaches wherein the patient includes a designated representative associated with the patient according to the patient personal data. (para. 74; care giver such as doctor)
With respect to Claim 92, it is substantially similar to Claim 77 and is rejected in the same manner, the same art and reasoning applying. Further, Witchey also teaches a system comprising: a computer comprising a processor configured to: (para. 29; processor)
With respect to Claims 93-96, they are substantially similar to Claims 80-83, respectively, and are rejected in the same manner, the same art and reasoning applying.
Remarks
Applicant argues at Remarks, pg. 7 that the amendment fixes the 112bs. Examiner agrees and withdraws the rejections.
Applicant argues at Remarks, pg. 8 that the references fail to teach a consent validating input. Examiner agrees and cites new art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS P CELANI whose telephone number is (571)272-1205. The examiner can normally be reached on M-F 9-5.
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/NICHOLAS P CELANI/Examiner, Art Unit 2449
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