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
This office action is in response to amendment/reconsideration filed on 1/23/2026, the amendment/reconsideration has been considered. Claim 13 have been amended. Claims 1-20 are pending for examination as cited below.
Response to Arguments
Applicant's arguments filed on 1/23/2026 have been fully considered but they are not persuasive. In remarks applicant argues in substance that:
a. 1. Response to Applicant’s U.S.C. 101 arguments:
Applicant argues that the claims recite “sophisticated algorithms,” “deep learning model,” and “data flows that cannot be performed in the human mind.” However, the claims do not recite any specific technical improvement to machine learning, blockchain, or medical data system.
Instead, the claims recite generic computer functions such as:
Receiving medical data
Storing summaries in a blockchain ledge
Filtering records based on criteria
Granting access based on approval status
Optionally generating a machine-learning model
These are results-oriented functional statements, not technological improvements
The specification confirms the abstract nature of the invention. Applicant’s own disclosure describes the managing entity as a marketplace platform that”
Receives medical data
Stores metadata on blockchain
Evaluates user-specified criteria
Grants access based on patient approval
Optionally generates ML models
(see US 2024/0281561 A1) paragraphs: [0017]-[0023].
These are business logic and data-management operations, which fall squarely with in the abstract idea categories of:
Organizing human activity
Managing transactions
Collecting ,analyzing, and displaying data
2. No specific ML algorithm or blockchain improvement is claimed
Although the specification mentions deep learning modes [0019], the claims do not recite:
Any architecture
Any training method
Any loss function
Any improvement to ML efficiency
Any improvement to blockchain consensus, hashing, or storage
Thus, the claims merely invoke ML and blockchain as generic tools, which is insufficient under MPEP 2106.05(f).
3. No integration into a practical application
The steps of:
Filtering records
Granting access
Recording a transaction
Are routine post-solution activity and do not transform the abstract idea into a practical application. Therefore, applicant’s arguments are not persuasive. The rejection under 35 U.S.C. 101 is hereby maintained.
II. Response to Applicant’s art rejection under 35 U.S.C. 102
Applicant argues that James et al. only stores “security tokens” on a blockchain an does not store or evaluate medical data as arranged in the claim.
Examiner respectfully disagree because after re-examining James, the rejection is maintained because James does disclose:
Receiving medical data
Storing metadata in a blockchain
Evaluating metadata
Granting access
Providing lists of available medical records
Recording transactions
(a) James handles medical images and associated patient data
James states: “DICOM study…is a collection of one or more medical images and patient data combined in file format structure” (James [0073]).
(b) James stores metadata - including access-control metadata – on blockchain
James discloses: “security tokens…. May be stored in a blockchain enabled decentralized metadata repositories and blockchain data ledges.” (James [0074]).
(c) James evaluates metadata to determine access permissions
James states: “security tokens ….selectively providing access…may be created, read, updated and deleted….before, during or after collaboration sessions.” (James [0074]). This corresponds to “access-approval status” in the instant claim.
(d) James provides lists of available medical records
James describes a collaboration system where: “collaborators may grant or restrict file access among each other” (James, [0073]).
(e ) James record transactions
James repeatedly describes updating metadata and tokens during collaboration sessions, which constitutes recording transactions.
Therefore, applicant’s argument that James only stores “tokens” is not persuasive. James’s tokens s are metadata describing medical records, stored on a blockchain, used to determine access, and updated during transactions.
III. Response to Applicant’s 35 U.S.C. 103 Arguments (James in view of Smith)
Applicant argues that Smith does not cure the deficiencies of James. However, Smith explicitly teaches,
Pricing of data
Access-control rules
Data-stream selection
Data-marketplace transactions
User-specified criteria
Filtering of data streams
Posting and updating metadata
Logging transactions
(a) Smith teaches a data marketplace with pricing and access control.
Smith states: “the invention provides method and system to enable buyers and sellers of data idents….to set, manage, and collect fees…” (Abstract)
(b) Smith teaches filtering data based on user-specified criteria
Smith describes: “detecting attributes of items…evaluating data streams…observing achievement of conditions for triggered events” (Smith, fig.1 and fig.2).
(c ) Smith states: “transaction logging and recording …data chain linking.” (Smith fig.3) and this corresponds to “recording the data transaction to the blockchain.” Therefore, Smith supplies the marketplace, pricing, criteria-based filtering, and transactions-logging features that complement James’s blockchain based medical-data access system.
IV. Response to Applicant’s arguments under 35 U.S.C. 103 rejection the combination of James and Horelick.
Applicant argues that Horelick is unrelated to medical data.
Horlick however teaches:
Remote data acquisition
Remote device control
Transmitting data to a central entity
Evaluating event data
Dispatching resources based on criteria
Logging events
(a) Horelick teaches remote data processing and evaluation
Horelick states: “Such UAVs can collect and transmit audio/visual content…analyzed to identify further aspects of the ongoing emergency.” (Hor, [0021]).
(b) Horelick teaches event-type criteria and filtering
Horelick describes: “determining that an emergency event…corresponds to an emergency type….”(Horelick, [0022]) which corresponds to “user-specified criteria in the instant claim limitation.
(c ) Horelick teaches logging transactions
Horelick repeatedly describes updating queues, flags, and logs (fig.13-15). Therefore, Horelick provides teachings on remote data processing, criteria-based evaluation and transaction logging, which reinforces the obviousness of the dependent claims.
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.
As to claim 1, the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the recited limitations e.g. retrieving a medical record….; filtering information or setting up a user specified criteria to retrieve data… and accessing the data based on specified criteria and be performed via mental steps and hence falls into an abstract idea.
The claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) (a) with agreement of an owner of the medical data, a managing entity receiving the medical data….; (b) the managing entity responding to an electronic request from a remote user for medical data meeting user-specified criteria,…; and (c) the managing entity responding to the remote user selecting one or more of the qualifying medical records by granting the remote user access to….).
The second step is Step 2A prong 1, “Does the claim recites a judicial exception (an abstract idea)?” Yes. Claim1, 12 and 21 limitations of “ retrieving data based on user specified credentials from a database, under broadest reasonable interpretation can be performed as a mental step/process. If a claimed limitation, under its broadest interpretation, can be performed as metal step or part tied to a generic computer component, then it falls within the “Mental Process/step” grouping of an abstract idea. Accordingly, the claims 1 recite an abstract idea. Step 2A Prong 2, “Evaluating additional elements in the claims to determine whether they integrate the exception into a practical application of the exception” No. There are no additional elements in the claims that can be integrated as an exception into a practical application of the exception. All of the elements claimed can be interpreted as an abstract idea. The next step is Step 2B, “evaluate whether the claim recites an additional element that amount to an inventive concept (aka “significantly more”) than the recited judicial exception.” No. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, introducing various level of security at different level, protecting payload portion in a data packet, using various protocol are well know in the art e.g. using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 1138 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result--a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink."));
Therefore, claims 2-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The cited claims are all directed towards an abstract idea (mental process), insignificant extra-solution activity to the judicial exception, or merely well-understood, routine. The claims are not patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 and 5-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by James et al. (Pub. No.: US 2019/0355483 A1), hereinafter “James”.
As to claim 1. James discloses, a method for implementing a transaction of medical data (James, Abstract), comprising:
with agreement of an owner of the medical data (James, [0074], security token), a managing entity receiving the medical data for storage and recording a summary of the received medical data to a blockchain computer network maintaining an electronic ledger of available medical records (James, [0073], metadata repositories which house reference links to collaborated imagery files, along with dicomized cognitive collaboration security tokens which provide granular control over access to shared imagery files stored in clinical data repositories);
the managing entity responding to an electronic request from a remote user for medical data meeting user-specified criteria, by providing the remote user with a listing of available qualifying medical records that meet the user-specified criteria, as determined at least in part from the electronic ledger (James, [0074], Security tokens for cognitive collaboration, selectively providing access to imagery information objects, their associated metatdata and annotations, including personal health information (PHI), can be created, read, updated or deleted, with concurrence by or among one or more participant cognitive collaborants, before, during or after cognitive collaborations sessions.);
the managing entity responding to the remote user selecting one or more of the qualifying medical records by granting the remote user access to the selected qualifying medical records in accordance with an access-approval status for each qualifying medical record granted by the owner of the qualifying medical record and recording the data transaction to the blockchain computer network (James, [0075], This approach of generating input illustrations on TIMS Clini-Pod Network Servers (CNS), and distributing only those input illustrations and not the underlying images to each participant cognitive collaborant, significantly improves operating performance and reduces image latency and wait times.).
As to claim 2. James discloses, wherein: the managing entity further receives from the remote user an access-type request indicating a type of data access being requested (James, [0073], metadata repositories which house reference links to collaborated imagery files, along with dicomized cognitive collaboration security tokens which provide granular control over access to shared imagery files stored in clinical data repositories);
the access-type request including one or more of data viewing, temporary data access with expiration period, permanent data access with data download, and data processing remote from the remote user and managed by the managing entity (James, [0072], TIMS Clini-Pod Network Servers (CNS) include software components that manage streaming requests to TIMS Clini-Docks; manage authentication and authorization tasks for access and privileges.).
As to claim 3. The method of claim 2, wherein permanent access with data download includes removal of the accessed qualifying medical data from the listing of available medical records in the electronic ledger (James, [0072], manage web services interactions with TIMS Clini-Ports; send, query and retrieve collections of one or more streaming imagery data files, including collaborated imagery files, also known as studies, to and from image repositories, as depicted in FIGS. 10 and 11).
As to claim 5. James discloses, wherein data processing managed by the managing entity includes generation of a machine learning model using the selected medical records and granting the remote user access to the generated machine learning model (James, [0008]).
As to claim 6. James discloses, wherein the generated machine learning model includes a deep learning model selected from one or more of an artificial neural network, convolutional neural network, u-net, recurrent neural networks, generative adversarial networks, and multilayer perceptrons (James, [0008]).
As to claim 7. James discloses, wherein the generated machine learning model includes a machine learning model based one or more of a classification model, regression model, clustering, and dimensionality reduction (James, [0012]).
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.
Claim(s) 4, 8, 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over James as applied above in view of Smith et al. (Pub. No.: US 2012/0316993 A1), hereinafter “Smith”.
As to claim 4. James discloses the invention substantially as applied above. James however is silent to disclose explicitly, wherein each access- type request has an associated access-price payable by the remote user.
Smith discloses a similar concept in the same field of endeavor including, wherein each access-type request has an associated access-price payable by the remote user. (Smith, [0017]).
Therefore, before the effective filing date of the instant application it would have been obvious to one of the skilled in the art to incorporate the teachings of “Smith” into those of James to provide a system to enable buyers and sellers of data items associated with data streams housed on electronically readable data tags or data streams contained within digitally transmissible messages or data streams generated by devices capable of implementing computer readable code to set, manage, and collect fees for the one or a plurality of data items and for the processing, collection, and posting of the one or a plurality of data items.
As to claim 8. The combined system of James and Smith disclose the invention including, wherein the owner of the medical data is the patient described by the medical data (Smith, [0005]).
As to claim 9. The combined system of James and Smith disclose the invention including, wherein the medical data includes medical measurements or images taken by a medical device, and the medical device automatically sends the medical data to the managing entity with consent from the patient (James, [0039] and [0080]).
As to claim 20. The combined system of James and Smith discloses the invention as applied above including, wherein the privileged users are identified based on access-criteria established by the managing entity, including one or more of prior given-authorization, number of medical records submitted by the privileged users for storage to the managing entity, and prior agreed-upon subscription period (James, [0071]-[0075], the limitations are merely an intended use and can be derived and tailored as needed from the system described above.).
Claim(s) 10-19 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over James as applied above in view of Horelick et al. (Pub. No.: US 2020/0346751 A1), hereinafter “Hor”.
As to claim 10. James discloses the invention as in parent claim above. James however is silent to disclose explicitly, wherein the owner of the medical data is identified by a public identifier based on a public key that is associated with a corresponding private key, the public identifier excluding any personal identifying information, whereby the managing entity maintains hidden any personal identifying information of the owner of the medical data.
Hor discloses a similar concept in the same field of endeavor including, , wherein the owner of the medical data is identified by a public identifier based on a public key that is associated with a corresponding private key (Hor, [0091]), the public identifier excluding any personal identifying information, whereby the managing entity maintains hidden any personal identifying information of the owner of the medical data (Hor, [0092]).
Therefore, before the effective filing date of the instant application it would have been obvious to one of the skilled in the art to incorporate the teachings of “Hor” into those of James to provide a method includes monitoring a plurality of emergency event queues at an emergency network entity; determining that an emergency event in one of the emergency event queues corresponds to an emergency type that can be responded to using an unmanned aerial vehicle; determining that an unmanned aerial vehicle is available that has capabilities corresponding to the emergency type; establishing an unmanned aerial vehicle control link between the unmanned aerial vehicle and the emergency network entity; and deploying the unmanned aerial vehicle to the emergency event location and providing data from the unmanned aerial vehicle on a display of the emergency network entity.
As to claim 11. The combined system of James and Hor discloses the invention as applied above including, wherein: the listing of available qualifying medical records that meet the user-specified criteria includes a count of qualifying medical records; and the managing entity responds to an electronic altering of the user-specified criteria by providing the remote user with an updated listing of available qualifying medical records that meet the altered user-specified criteria (James, [0072], the limitations are merely an intended use and can be derived and tailored as needed from the system described above.).
As to claim 12. The combined system of James and Hor discloses the invention as applied above including, wherein the managing entity: in response to the remote user selecting one or more of the qualifying medical records, checking for a pre-existing access-approval status for each of the selected qualifying medical records; and for each selected qualifying medical record not having a pre-existing access-approval status, transmitting a request for approval to the owner of the qualifying medical record, and updating the approval status of the qualifying medical record in accordance with the owner's approval response ((James, [0071]-[0075], the limitations are merely an intended use and can be derived and tailored as needed from the system described above.).
As to claim 13. The combined system of James and Hor discloses the invention as applied above including, wherein the managing entity: in response to the remote user specifying a desired number of qualifying medical records, checking for a pre-existing access-approval status for each of the qualifying medical records; and in response to a sufficient number of qualifying medical records having a pre-existing access-approval status, selecting the desired number of qualifying medical records from among those having a pre-existing access-approval status; in response to an insufficient number of qualifying medical records having a pre-existing access-approval status, determining how many additional qualifying medical records are needed to meet the specified desired number, and for each additionally needed qualifying medical record, transmitting a request for approval to the owner of the additionally needed qualifying medical record, and updating the approval status of the additionally needed qualifying medical record in accordance with the owner's approval response ((James, [0071]-[0075], the limitations are merely an intended use and can be derived and tailored as needed from the system described above.).
As to claim 14. The combined system of James and Hor discloses the invention as applied above including, wherein the managing entity: responds to the electronic request from the remote user for medical data meeting user- specified criteria, by providing the remote user with a price list associate with the listing of available qualifying medical records; and responds to the remote user selecting one or more of the qualifying medical records, by collecting the price associated with the qualifying medical records to which the remote user is granted access, and distributing a payment to one or more of each selected qualified medical record owner, medical institution that collected any of the qualifying medical records to which the remote user was granted access, and data host that hosts any of the qualifying medical records to which the remote user was granted access (James, [0071]-[0075], the limitations are merely an intended use and can be derived and tailored as needed from the system described above.).
As to claim 15. The combined system of James and Hor discloses the invention as applied above including, wherein the blockchain computer network is a public ledger computer network (James, [0074]).
As to claim 16. The combined system of James and Hor discloses the invention as applied above including, wherein the received medical data is at least partly stored on-chain within the blockchain computer network and off-chain external to the blockchain computer network (James, [0050], external or remote and [0074], blockchain).
As to claim 17. The combined system of James and Hor discloses the invention as applied above including, wherein in response to the remote user being a doctor to which a patient is being referred to, and the user-specified criteria specifies medical records of the patient only, the managing entity maintains an automatic access-approval status for the qualifying medical records (James, [0039]).
As to claim 18. The combined system of James and Hor discloses the invention as applied above including, wherein in response to the remote user being the owner of the medical data and the user-specified criteria specifying only medical records of the owner of the medical data, the managing entity maintains an automatic access-approval status for the qualifying medical record (James, [0071]-[0075], the limitations are merely an intended use and can be derived and tailored as needed from the system described above.).
As to claim 19. The combined system of James and Hor discloses the invention as applied above including, wherein the managing entity maintains a group of privileged remote users, each of which has unimpeded review-access to the electronic ledger (James, [0071]-[0075], the limitations are merely an intended use and can be derived and tailored as needed from the system described above.).
As to claim 21. The combined system of James and Hor discloses the invention as applied above including, wherein the user-specified criteria submitted by the remote user includes one or more of a type of anatomical measurement, body function measurement, a data scan type, and an image type (James, [0071]-[0075], the limitations are merely an intended use and can be derived and tailored as needed from the system described above).
As to claim 22. The combined system of James and Hor discloses the invention as applied above including, wherein: the anatomical measurement includes one or more of eye pressure, keratometry measurements, refractive error, or eye size; the body function measurement includes one or more of an electrocardiogram, body temperature, pulse rate, or respiration rate; the data scan type includes one or more of an A-scan, B-scan, or C-scan from an optical coherence tomography device; and the image type includes one or more of a fundus image, an en-face image, or an ophthalmic anterior segment image (James,[0050], [0071]-[0075], the limitations are merely an intended use and can be derived and tailored as needed from the system described above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see the attached PTO-892.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAUQIR HUSSAIN whose telephone number is (571)270-1247. The examiner can normally be reached M-F 7:00 - 8:00 with IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian J Gillis can be reached at 571 272-7952. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Tauqir Hussain/Primary Examiner, Art Unit 2446