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 .
DETAILED ACTION
Status of Claims
Original claims 1-20 filed 3/3/2025 are pending and have been examined.
Priority
This application claims priority to U.S. Provisional Patent Applications No. 63/565,662 filed 03/15/2024 and No. 63/565,659 filed 03/15/2024.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS)(s) submitted on 5/15/2025 and 3/30/2026 follow(s) the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Claim Objections
Claims 6 and 9-10 are objected to because of the following informalities:
Claim 6 further defines the selecting of an intervention as selecting a digital therapeutic program. Claim 6 further defines the communicating as communicating the selected digital therapeutic program. Claim 6 further defines the receiving of a record as receiving a patient consent record. Claim 6 further defines adding a recorded intervention as adding an indication of the digital therapeutic program. The Examiner suggests amending to recite “further comprises” for each of these steps to indicate that these limitations are further defining the method of claim 1. Appropriate correction is required.
Similarly, Claims 9-17 further define one or more steps of parent claim(s). The Examiner suggests amending to recite “further comprises” to indicate narrowing limitations. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Appropriate correction is required.
Claims 1 and 20 recite “storing… a plurality of valuation rules… attributing a valuation for each of the members” and “assessing one or more given valuations… for a given one or more of the members based on the valuation rules” (emphasis added) (claim 1 being representative). It is unclear how multiple valuations for a single entity can exist and be assessed when the claim describes each entity as having one valuation. The rejection of claims 1 and 20 also applies to dependent claims 1-19.
Claim 7 recites “assessing a given one or more of the assessed valuations for both the given patient and the given provider” (emphasis added). Claim 7 is further indefinite because it is unclear how multiple ("or more") valuations for a given provider and patient can be assessed. As per Claim 1, each entity has one valuation associated with them. Claim 7 states that multiple valuations exist for each entity (patient and provider). The claim is further indefinite because it is unclear whether the assessing is performed once (the assessing of claim 1) or multiple times (the assessing of claim 7). Similarly, the claim is indefinite because it is unclear if the "adding" limitation is performed once (as in claim 1) or multiple times (as in claim 7); an assessment valuation for all the members was previously added to the distributed ledger.
Claim 10 recites “assessing comprises assessing a given one or more of the assessed valuations for the given patient and the given provider based on the valuation rules” and “adding comprises adding the given one or more assessed valuations for both the given patient and the given provider” (emphasis added). The rejections applied to claim 7 also apply to claim 10 mutatis mutandis.
Claim 12 recites “assessing comprises assessing a given one or more of the assessed valuations for the given provider based on the valuation rules” and “adding comprises adding the given one or more assessed valuations for the given provider” (emphasis added). The rejections applied to claim 7 also apply to claim 12 mutatis mutandis.
Claim 14 recites “assessing comprises assessing a given one or more of the assessed valuations for the given patient based on the valuation rules” and “adding comprises adding the given one or more assessed valuations for the given patient” (emphasis added). The rejections applied to claim 7 also apply to claim 14 mutatis mutandis.
Claim 18 recites the phrases “etc.” and “like” in one or more limitations. Each phrase in each instance renders the claim indefinite because it is unclear whether the limitation(s) following each phrase instance are part of the claimed invention. See MPEP § 2173.05(d). Alternately, each phrase in each instance renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by “etc.” or "like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 at least fails to further limit the method of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ
644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(1)(1) -706.02(1)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321 (b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
Claims 1-20 are provisionally rejected on the grounds of non-statutory double patenting over claims 1-19 of co-pending Application No. 19/068,861 (reference Application ‘861) in view US 2024/0070627 A1 to Galterio. Although the claims at issue are not identical, they are not patentably distinct from each other as set forth below.
Claims 1 and 20 of the instant Application recite substantially similar limitations to claims 1 and 19 of the reference Application ‘861. The subject matter in the instant application amounts to claims which are generally broader in scope. The additional limitations recited in the instant Application pertaining to “a plurality of valuation rules… attributing a valuation for each of the members for the interventions”, “assessing one or more given valuations, as one or more assessed valuations, of the recorded intervention for a given one or more of the members based on the valuation rules”, and “adding the one or more assessed valuations to the distributed ledger” are rendered obvious over the reference Application ‘861 in view of Galterio.
The Examiner has bolded or italicized the claim language that is the same between the claims of the instant Application, corresponding claims of the co-pending reference Application ‘861 and disclosure (claims or paragraphs) of Galterio.
Claims of Instant Application ‘918
Claims of Reference Application ‘861
Disclosure of Galterio
1. A method, used in a distributed network system between a plurality of network nodes in a healthcare environment, to fulfill proof of value transactions according to a consensus contract, the network nodes being at least associated with one or more members in the healthcare environment that include patients, providers, and payers, the method comprising
storing, in one or more databases of the distributed network system, (i) a plurality of intervention rules governed by the consensus contract, the intervention rules defining a plurality of interventions in response to events, (ii) a plurality of valuation rules governed by the consensus contract, the valuation rules attributing a valuation for each of the members for the interventions, and (iii) a plurality of communication rules governed by the consensus contract, the communication rules defining a plurality of communications with each of the network nodes for the interventions;
building, with one or more processors of the distributed network system, a distributed ledger for a given patient by:
receiving a given event for the given patient;
adding the given event to the distributed ledger based on the communication rules;
selecting a given intervention, as a selected intervention, in response to the given event based on the intervention rules;
communicating the selected intervention, as a communicated intervention, to a given one of the network nodes based on the communication rules;
receiving a record of the communicated intervention, as a recorded intervention, in response to the communication;
adding the recorded intervention to the distributed ledger in response to the record;
assessing one or more given valuations, as one or more assessed valuations, of the recorded intervention for a given one or more of the members based on the valuation rules; and
adding the one or more assessed valuations to the distributed ledger; and
configuring a settlement of the one or more assessed valuations for the given one or more of the members according to the consensus contract by distributing the distributed ledger in the distributed network system.
1. A method, used in a distributed network system between a plurality of network nodes in a healthcare environment, to fulfill proof of value transactions according to a consensus contract, the network nodes being at
least associated with one or more members in the healthcare environment that include patients, providers, and payers, the method comprising
storing, in one or more databases of the distributed network system, (i) a
plurality of intervention rules governed by the consensus contract, the
intervention rules defining a plurality of interventions in response to
events, (ii) a plurality of context rules defining context indicators for
factual circumstances associated with the patients, and (iii) a plurality
of communication rules governed by the consensus contract, the
communication rules defining a plurality of communications with each
of the network nodes for the interventions;
building, with one or more processors of the distributed network system, a
distributed ledger for a given patient by:
receiving a profile having one or more of the factual circumstances
associated with the given patient;
attributing one or more context indicators for the one or more factual
circumstances in the profile based on the context rules;
adding the one or more context indicators to the distributed ledger;
receiving a given event for the given patient;
adding the given event to the distributed ledger based on the communication rules;
selecting a first of the interventions, as a first selected intervention,
based on the one or more context indicators;
communicating the first selected intervention, as a first communicated
intervention, to a given one or more of the network nodes based
on the communication rules;
receiving a first record of the first communicated intervention, as a first
recorded intervention, in response to the communication; and
adding the first recorded intervention to the distributed ledger in
response to the first record; and
distributing the distributed ledger in the distributed network system.
8. The method of claim 1, further comprising storing, in the one or
more databases, (iv) a plurality of valuation rules governed by the consensus
contract, the valuation rules attributing a valuation for each of the members for the
interventions.
9. The method of claim 8, wherein building the distributed ledger for the given patient comprises:
assessing one or more first valuations, as one or more first assessed
valuations, of the first recorded intervention for a given one or more of the members based on the valuation rules; and
adding the one or more first assessed valuations to the distributed ledger; and
wherein the method further comprises: configuring a settlement of the one or more first assessed valuations for the given one or more of the members according to the consensus contract by distributing the distributed ledger in the
distributed network system.
4. … PoP consensus protocol of said blockchain acts to validate
records though proof of patient; proof of provider; and proof
of pharmacy after proof of stake is performed using cryptocurrency
rewards for participants…
Fig. 1: “Consensus: PoP, “Proof of Patient/Provider/Pharmacy/Payer” mining and learning technique achieved via patient consent and human validation…”
Fig. 12: “The trans-actions and data are broadcast to a network of nodes, which validate and reach consensus on the data to be added to the blockchain.”
2. The method of claim 1, wherein the intervention rules defining the interventions in response to the events define how each of the events are detected and how the interventions are subsequently selected.
2. The method of claim 1, wherein the intervention rules defining the interventions in response to the events define how each of the events are detected and how the interventions are subsequently selected.
3. The method of claim 1, wherein the valuation rules
attributing the valuation for each of the given one or more members for the interventions define how the recorded interventions are detected and how the recorded interventions are subsequently valued.
12. The method of claim 8, wherein the valuation rules
attributing the valuation for each of the members for the interventions define how recorded interventions are detected and how the recorded interventions are
subsequently valued.
4. The method of claim 1, wherein the communication rules defining the communications with each of the network nodes for the interventions define how
the distributed network system interfaces with each of the network nodes in sending
and receiving the communications.
3. The method of claim 1, wherein the communication rules defining the communications with each of the network nodes for the interventions define how
the distributed network system interfaces with each of the network nodes in sending
and receiving the communications.
5. The method of claim 1, wherein receiving the given event for the given patient comprises receiving a diagnosis for the given patient from a given provider, thereby adding the diagnosis to the distributed ledger.
4. The method of claim 1, wherein receiving the given event for the given patient comprises receiving an observation of the given patient, the given
patient having a stated medical condition, thereby adding the observation for the
stated medical condition to the distributed ledger.
6. The method of claim 5, wherein:
selecting comprises selecting a digital therapeutic program, as the selected intervention, in response to the diagnosis based on the intervention rules;
communicating comprises communicating the digital therapeutic program, as the communicated intervention, to the given patient based on the communication rules;
receiving comprise receiving a consent from the given patient to the digital therapeutic program, as the record, in response to the communication; and
adding comprises adding an indication of the digital therapeutic program, as the recorded intervention, to the distributed ledger in response to the consent.
5. The method of claim 1, wherein:
selecting comprises selecting a directed action for a given provider, as the
first selected intervention, based on the one or more context indicators;
communicating comprises communicating the directed action, as the first
communicated intervention, to the given provider based on the communication rules;
receiving comprise receiving an indication of completion of the directed action,
as the first record, in response to the communication; and
adding comprises adding the indication of completion of the directed action, as the first recorded intervention, to the distributed ledger in response
to the indication.
7. “… selecting a directed action based on the intervention rules…”
Fig. 1 – patient consent
7. The method of claim 6, wherein: assessing comprises assessing a given one or more of the assessed valuations for both the given patient and the given provider based on the valuation rules; and
adding comprises adding the given one or more assessed valuations for both the given patient and the given provider to the distributed ledger.
9. The method of claim 8, wherein building the distributed ledger for the given patient comprises:
assessing one or more first valuations, as one or more first assessed
valuations, of the first recorded intervention for a given one or more of the members based on the valuation rules; and
adding the one or more first assessed valuations to the distributed ledger; and wherein the method further comprises: configuring a settlement of the one or more first assessed valuations for the given one or more of the members according to the consensus contract by distributing the distributed ledger in the distributed network system.
4. … PoP consensus protocol of said blockchain acts to validate
records though proof of patient; proof of provider; and proof
of pharmacy after proof of stake is performed using cryptocurrency
rewards for participants…
8. The method of claim 1, wherein receiving the given event for the given patient comprises receiving an observation of the given patient, the given patient having a stated medical condition, thereby adding the observation for the stated medical condition to the distributed ledger.
4. The method of claim 1, wherein receiving the given event for the given patient comprises receiving an observation of the given patient, the given patient having a stated medical condition, thereby adding the observation for the
stated medical condition to the distributed ledger.
9. The method of claim 8, wherein:
selecting comprises selecting a directed action for the given patient to contact a given provider, as the selected intervention, in response to the observation based on the intervention rules for the stated medical condition;
communicating comprises communicating the directed action, as the communicated intervention, to the given patient based on the communication rules;
receiving comprise receiving an indication of completion of the directed action, as the record, in response to the communication; and
adding comprises adding the indication of completion of the directed action, as the recorded intervention, to the distributed ledger in response to indication.
7. The method of claim 6, wherein:
selecting comprises selecting a directed action for the given patient, as the second selected intervention, based on the intervention rules;
communicating comprises communicating the directed action, as the second
communicated intervention, to the given patient based on the
communication rules;
receiving comprise receiving an indication of completion of the directed action, as the second record, in response to the communication; and
adding comprises adding the indication of completion of the directed action, as the second recorded intervention, to the distributed ledger in
response to the indication.
4. “…receiving an observation of the given patient, the given patient having a stated medical condition, thereby adding the observation for the stated medical condition to the distributed ledger.”
10. The method of claim 9, wherein:
assessing comprises assessing a given one or more of the assessed valuations for the given patient and the given provider based on the valuation rules; and
adding comprises adding the given one or more assessed valuations for both the given patient and the given provider to the distributed ledger.
See claim 9.
11. The method of claim 8, wherein:
selecting comprises selecting a directed action for a given provider, as the selected intervention, in response to the observation based on the intervention rules for the stated medical condition;
communicating comprises communicating the directed action, as the communicated intervention, to the given provider based on the communication rules;
receiving comprise receiving an indication of completion of the directed action, as the record, in response to the communication; and
adding comprises adding the indication of completion of the directed action, as the recorded intervention, to the distributed ledger in response to the indication.
5. The method of claim 1, wherein:
selecting comprises selecting a directed action for a given provider, as the
first selected intervention, based on the one or more context indicators;
communicating comprises communicating the directed action, as the first
communicated intervention, to the given provider based on the communication rules;
receiving comprise receiving an indication of completion of the directed action,
as the first record, in response to the communication; and
adding comprises adding the indication of completion of the directed action, as the first recorded intervention, to the distributed ledger in response
to the indication.
4. “…receiving an observation of the given patient, the given patient having a stated medical condition…”
7. The method of claim 6, wherein:
selecting comprises selecting a directed action for the given patient, as the second selected intervention, based on the intervention rules;
communicating comprises communicating the directed action, as the second
communicated intervention, to the given patient based on the
communication rules;
receiving comprise receiving an indication of completion of the directed action,
as the second record, in response to the communication; and
adding comprises adding the indication of completion of the directed action,
as the second recorded intervention, to the distributed ledger in
response to the indication.
12. The method of claim 11, wherein:
assessing comprises assessing a given one or more of the assessed valuations for the given provider based on the valuation rules; and
adding comprises adding the given one or more assessed valuations for the given provider to the distributed ledger.
See claim 9.
13. The method of claim 8, wherein:
selecting comprises selecting a therapeutic reward for the given patient, as the selected intervention, by measuring the observation, and optionally any past observations, against a threshold goal based on the intervention rules for the stated medical condition;
communicating comprises communicating the therapeutic reward, as the communicated intervention, to the given patient based on the communication rules;
receiving comprise receiving an indication of the therapeutic reward, as the record, in response to the communication; and
adding comprises adding the therapeutic reward, as the recorded intervention, to the distributed ledger in response to the indication.
7. The method of claim 6, wherein:
selecting comprises selecting a directed action for the given patient, as the second selected intervention, based on the intervention rules;
communicating comprises communicating the directed action, as the second communicated intervention, to the given patient based on the
communication rules;
receiving comprise receiving an indication of completion of the directed action, as the second record, in response to the communication; and
adding comprises adding the indication of completion of the directed action, as the second recorded intervention, to the distributed ledger in
response to the indication.
17. “… wherein the interventions include… a directed action… a reward…”
16. “… informing the intervention rules based on at least one of fixed thresholds and the Al model to formulate the interventions for each of the members.”
[0299] We take this trigger point and use the data in the payment, compared against a submission…
[0302] “The Registry takes the clinical codes from the patient charge along with other clinical data from the provider’s systems, and equates them to Quality Measures”
14. The method of claim 13, wherein:
assessing comprises assessing a given one or more of the assessed valuations for the given patient based on the valuation rules; and
adding comprises adding the given one or more assessed valuations for the given patient to the distributed ledger.
See claim 9.
15. The method of claim 1, wherein configuring the settlement by distributing the distributed ledger comprises:
adding data including the given event, the recorded intervention, and the one or more assessed valuations in blocks to the distributed ledger based on a consensus protocol dictating how to add or modify entries in the distributed ledger; and
automatically fulfilling terms of the consensus contract in response to predefined conditions being met by coding terms of the consensus contract into code used in the distributed network system.
10. The method of claim 9, wherein configuring the
settlement by distributing the distributed ledger comprises: adding data including the given event, the first recorded intervention, and the
one or more first assessed valuations in blocks to the distributed ledger and including, in each block, a unique cryptographic hash of a previous block in the distributed ledger; and
automatically fulfilling terms of the consensus contract in response to predefined conditions being met by coding terms of the consensus contract into code used in the distributed network system.
4. … PoP consensus protocol of said blockchain acts to validate records though proof of patient; proof of provider; and proof
of pharmacy after proof of stake is performed…
Fig. 12: “The trans-actions and data are broadcast to a network of nodes, which validate and reach consensus on the data to be added to the blockchain.”
[0503] employ algorithms to validate the transaction and the user's status. Once the transaction has been verified, it is combined with other transactions to create a new block of data for the ledger.
16. The method of claim 1, wherein to assess the one or more assessed valuations, the method comprises using an artificial intelligence (Al) model.
See claim 1.
15. the method comprises using an artificial intelligence (Al) model trained by training data including the factual circumstances associated with a plurality of the patients.
17. The method of claim 16, wherein to use the Al model, the method comprises: training the Al model to score a plurality of interventions based on performance metrics; and informing the step of assessing the one or more given valuations based on the scoring by the Al model to formulate the one or more assessed valuations for the given one or more of the members.
See claims 1 and 15.
16. The method of claim 15, wherein to use the Al model, the method
comprises: training the Al model to detect a plurality of subtle scenarios from the context indicators and to indicate alternative courses of actions for the subtle
scenarios; and
informing the intervention rules based on at least one of fixed thresholds and the Al model to formulate the interventions for each of the members.
[0299] We take this trigger point and use the data in the payment, compared against a submission…
[0302] “The Registry takes the clinical codes from the patient charge along with other clinical data from the provider’s systems, and equates them to Quality Measures… Since these quality scores determine the adjustment to the rate of the… payment to the medical provider for Service…”
18. The method of claim 1, wherein the providers include one or more of a hospital, a doctor, a medical supplier, etc.; wherein the payers include one or more of health management company, a medical insurer, an insurance company, a health plan administrator, etc.; wherein the events include one or more of: a medical-related event, a therapeutic-related event, a diagnosis, a medical observation, a consumption of a medical supply, hospitalization of a care-giver, and a change to a patient's circumstances like financial, housing, or food security; and
wherein the interventions include one or more of a therapeutic protocol; a directed action, an adjustment to care plan, an educational material to raise condition literacy, an assistance to raise awareness about social program (like ride assistance or meal delivery), a delivery of a medical supply, and a reward for achieving therapeutic goals (like points programs, or reduced insurance cost).
17. The method of claim 1, wherein the providers include one or more
of a hospital, a doctor, a medical supplier, etc.; wherein the payers include one or more of health management company, a medical insurer, an insurance company, a
health plan administrator, etc.;
wherein the events include one or more of: a medical related event, a therapeutic-related event, a diagnosis, a medical observations, a
consumption of a medical supply, hospitalization of a care-giver, and a change to a patient's circumstances like financial, housing, or food security; and
wherein the interventions include one or more of a therapeutic protocol, a directed action, , an
adjustment to care plan, an educational material to raise condition literacy, an
assistance to raise awareness about social program (like ride assistance or meal
delivery), a delivery of a medical supply, and a reward for achieving therapeutic
goals (like points programs, or reduced insurance cost).
19. A programmable storage device having program instructions stored thereon for causing one or more programmable network devices to perform a method of claim 1, used in a distributed network system between a plurality of network nodes, to fulfill transactions according to a consensus contract.
18. A programmable storage device having program instructions stored
thereon for causing one or more programmable network devices to perform a method of claim 1, used in a distributed network system between a plurality of network nodes, to fulfill transactions according to a consensus contract.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date, to have modified the healthcare blockchain cryptosystem of Galterio to validate records using a proof-of-patient (PoP) consensus protocol for a blockchain (i.e., assess one or more given valuations of the record) that is implemented through various proofs of stake (i.e., proof of patient, proof of provider, and proof of pharmacy) using cryptocurrency rewards for participants (i.e., a plurality of valuation rules attributing a valuation for each of the members) (see claim 4 and Figs. 1, 12) and to use this information as part of the computer-implemented method and system as taught by the reference Application ‘861 claims, with the motivation of improving healthcare systems, e.g., improving data validation and patient care incentivization (see Galterio at para. 0006, 0104, 0301-0302).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 20 is analogous to claim 1; that is, the subject matter of claim 20 is essentially defined in terms of a system, which is technically corresponding to method claim 1. Since claim 20 is analogous to claim 1, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Dependent Claims 2-19 recite similar limitations to dependent claims 2-18 of the ‘861 application and are also rejected as being obvious variations of the claims of the ‘861 application in view of Galterio.
Dependent Claim 6 is provisionally rejected on the grounds of non-statutory double patenting over claim 5 of co-pending Application No. 19/068,861 (reference Application ‘861) in view of Galterio and US 2025/0195762 A1 to Corbett et al. (“Corbett” herein). Corbett teaches receiving data collected from an intelligent injection device 400 (see para. 0136) with the intelligent injection device microprocessor 510 recording the injection administration completion event and sending the administration data 800 over a wireless module 504 (see Fig. 5E and para. 0241). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date, to have modified the method, system and computer program product of prescription tracking and verification of Corbett to incorporate remote patient monitoring of administration of medication (i.e., a digital therapeutic program) and to use this information as part of the computer-implemented method and system as taught by the reference Application ‘861 claims/Galterio, with the motivation of improving remote patient monitoring and medication compliance (see Corbett at para. 0136).
Dependent claim 9 is provisionally rejected on the grounds of non-statutory double patenting over claims 4 and 7 of co-pending Application No. 19/068,861 (reference Application ‘861) in view of Galterio and US 2025/0000361 A1 to Soori-Arachi et al. (“Soori-Arachi” herein). Soori-Arachi teaches the telemedicine platform may assign an urgency level of 5, on a scale of 1-5, 5 being the most urgent and may recommend contacting a doctor urgently, proceeding to an urgent care facility promptly, or calling 911 (para. 0140-0141); and initiating a call with a telemedicine physician (para. 0141) (i.e., a directed action for the given patient to contact a given provider). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date, to have modified the AI-enabled multisensor-connected telehealth system of Soori-Arachi to incorporate real-time alerts into remote patient monitoring (see Soori-Arachi at Abstract and para. 0140-0141, 0211) and to use this information as part of the computer-implemented method and system as taught by the reference Application ‘861 claims/Galterio, with the motivation of improving diagnostic support and patient care (see Soori-Arachi at para. 0002, 0006-0007, 0017-0018).
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 1-20 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.
Claims 1 and 20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 (YES)
Claims 1 and 20 fall into at least one of the statutory categories (i.e., process or machine).
Step 2A1 (YES)
The claims recite an abstract idea. The identified abstract idea is a method, used in a distributed network system between a plurality of network nodes in a healthcare environment, to fulfill proof of value transactions according to a consensus contract, the network nodes being at least associated with one or more members in the healthcare environment that include patients, providers, and payers, as underlined (claim 1 being representative):
storing, in one or more databases of the distributed network system, (i) a plurality of intervention rules governed by the consensus contract, the intervention rules defining a plurality of interventions in response to events, (ii) a plurality of valuation rules governed by the consensus contract, the valuation rules attributing a valuation for each of the members for the interventions, and (iii) a plurality of communication rules governed by the consensus contract, the communication rules defining a plurality of communications with each of the network nodes for the interventions;
building, with one or more processors of the distributed network system, a distributed ledger for a given patient by:
receiving a given event for the given patient;
adding the given event to the distributed ledger based on the communication rules;
selecting a given intervention, as a selected intervention, in response to the given event based on the intervention rules;
communicating the selected intervention, as a communicated intervention, to a given one of the network nodes based on the communication rules;
receiving a record of the communicated intervention, as a recorded intervention, in response to the communication;
adding the recorded intervention to the distributed ledger in response to the record;
assessing one or more given valuations, as one or more assessed valuations, of the recorded intervention for a given one or more of the members based on the valuation rules; and
adding the one or more assessed valuations to the distributed ledger; and
configuring a settlement of the one or more assessed valuations for the given one or more of the members according to the consensus contract by distributing the distributed ledger in the distributed network system.
The identified claim elements, as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., fundamental economic principles or practices including insurance, commercial or legal interactions including agreements in the form of contracts, and/or managing personal behavior including following rules or instructions) but for recitation of generic computer components (discussed in Steps 2A2 and 2B). The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to fulfill proof of value transactions according to a consensus in the form of a contract between one or more members of a healthcare environment (see Spec. Para. 0006 and 0056 describing value-based consensus in contracting as a human activity) in the manner described in the identified abstract idea, supra. See MPEP 2106.04(a)(2)(II). The rules or instructions are the claimed steps of “storing…building… receiving… adding… selecting… communicating… receiving… adding… assessing… adding… and configuring (by distributing)…” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a system of systems implemented by one or more data processors (a computer network), the claimed invention amounts to managing personal behavior or interaction between people. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2 (NO)
The judicial exception, the above-identified abstract idea, is not integrated into a practical application. In particular, the claims recite the additional elements of one or more networks (claim 20); and a distributed network system comprising one or more databases, one or more processors, one or more interfaces (claim 20), and at least one given network node that implement the identified abstract idea (represented by claim 1). The additional elements aforementioned are not described by the applicant and are recited at a high-level of generality (i.e., each as a generic computer or computer component performing a generic computer or computer component function that facilitates the identified abstract idea) such that these amount no more than mere instructions to apply the exception using a generic computer component (see Applicant’s disclosure at Figs. 1, 9, 11 and para. 0033, 0153-0156, 0161-0163). See MPEP § 2106.04(d)(I). Accordingly, alone or in combination, these additional elements 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.
The claims further recite the additional elements of a consensus contract (i.e., a “smart” contract) that implements the identified abstract idea. The additional element is not described by the Applicant, is recited at a high-level of generality and is merely invoked as a tool to perform an existing process (MPEP § 2106.05(f)(2), see case involving a commonplace business method or mathematical algorithm being applied on a general-purpose computer within the “Other examples”), such that this amounts no more than mere instructions to apply the abstract idea on a general-purpose computer (see Spec. Para. 0050-0056 with para. 0055 disclosing a consensus contract as a “smart” contract). See MPEP § 2106.04(d)(I); and Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 134 S. Ct. 2347, 1357 (2014). Accordingly, even in combination, these additional elements 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.
The claims further recite the additional element of a distributed ledger that collects, transmits or outputs data. The additional element is recited at a high-level of generality (i.e., a general means of collecting, transmitting or outputting data) and amounts to a location from which data is received or to which data is transmitted or outputted, each of which represents an extra-solution activity (e.g., mere data gathering and data output). MPEP § 2106.04(d)(I) indicates that extra-solution data gathering and data output activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claims are directed to an abstract idea.
Step 2B (NO)
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 of one or more networks (claim 20); and a distributed network system comprising one or more databases, one or more processors, one or more interfaces, and at least one given network node (claims 1 and 20) to perform the method (represented by claim 1) amount no more than mere instructions to apply the exception using a generic computer or generic computer component. Mere instructions to apply an exception using generic computer(s) and/or generic computer component(s) cannot provide an inventive concept (“significantly more”). See MPEP § 2106.05(f).
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 element of a consensus contract (i.e., a “smart” contract) used to perform the method amounts no more than mere instructions to “apply it” with the exception by invoking an algorithm merely as a tool to perform an existing process (i.e., only recites the algorithm as a tool to apply data to an algorithm and report the results), in this case to receive input data (e.g., event data) and output output data (e.g., communication data). The use of a consensus contract or “smart” contract in its ordinary capacity to perform tasks in the identified abstract idea does not provide an inventive concept (“significantly more”). See MPEP § 2106.05(f). Accordingly, even in combination, the additional element does not provide significantly more.
Also discussed above with respect to integration of the abstract idea into a practical application, the additional element of a distributed ledger (i.e., means for collecting, transmitting or outputting data) is considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. MPEP 2106.05(d)(II) indicates that receiving, transmitting or outputting data over a network has been held by the courts to be well-understood, routine, conventional activity (citing TLI Communications, Symantec, OIP Techs., and buySAFE). See also MPEP 2106.05(g) (citing Cybersource, Mayo, OIP Techs.) Also, Galterio indicates that blockchain network technology is well-understood, routine, and conventional (see US 2024/0070627 A1 at Fig. 12). The Examiner further notes that the court in Rady v. Boston Consulting Group, Inc., No. 2022-2218, slip op. at 9 (Fed. Cir., March 27, 2024) held that blockchain technology is well-understood, routine, and conventional. Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). Thus, the claims are not patent eligible.
Dependent claims 2-19, when analyzed as a whole, are similarly rejected under 35 U.S.C. §101 because the additional limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. The claims, when considered alone or as an ordered combination, either (1) merely further define the abstract idea, (2) do not further limit the claim to a practical application, or (3) do not provide an inventive concept such that the claims are subject matter eligible.
Claim(s) 2-5 and 18 merely further describe(s) the abstract idea (e.g., the intervention rules, the valuation rules, the communication rules, receiving the given event, assessing a given assessed valuation, the providers, the payers, the events, the interventions). See analysis, supra.
Claim(s) 6-15 merely further recite the additional element of the distributed ledger that collects, transmits, or outputs data at a high level of generality (e.g., adding/recording the selected intervention / digital therapeutic program in response to receiving a patient consent record for the selected intervention / digital therapeutic program, adding/recording other data; distributing data, which further comprises adding data in blocks based on a consensus protocol dictating how to add or modify entries and automatically fulfilling terms of an agreement in response to predefined conditions being met by coding terms of the consensus agreement into code). See analysis, supra.
Claims 16-17 further recite “using an artificial intelligence (AI) model” (claim 16 being representative). When given its broadest reasonable interpretation in light of the disclosure, the use of an artificial intelligence model, which causes the model to assess the valuation(s), using linear regression or logistic regression described in the specification, represents the creation of mathematical interrelationships between data. The Examiner notes that the Applicant has described artificial intelligence to encompass simplistic mathematical models such as linear regression models and logistic regression models (see Spec. Para. 0120, 0127, 0132, 0148) and thus the artificial intelligence model is interpreted to be part of the abstract idea. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
Claim 17 further recites training of an artificial intelligence model. The type of training utilized by the claimed invention is not recited by the Applicant. As such the Examiner is required to analyze the training step given the broadest reasonable interpretation in light of the specification (see Applicant’s disclosure at para. 0132, 0148 describing linear regression and logistic regression). The step(s) performed to train or step(s) of the model/algorithm is/are considered to be part of the abstract idea because it/they fall(s) under data manipulations that humans perform (i.e., fitting a model to data) and thus are interpreted to be part of the abstraction--the rules or instructions that fall under Certain Methods of Organizing Human Activity. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 12 (Fed. Cir. April 18, 2025) (finding that “[i]terative training using selected training material…are incident to the very nature of machine learning.”). The training of the artificial intelligence model, which represents certain method(s) of organizing human activity, is interpreted to be part of the identified abstract idea, supra. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
Claim 19 further recites the additional element of a programmable storage device that implements the identified abstract idea. The additional element is not described by the Applicant and is recited at a high-level of generality (i.e., as a generic computer or computer component performing a generic computer or computer component function that facilitates the identified abstract idea) such that this amounts no more than mere instructions to apply the exception using a generic computer component (see Applicant’s disclosure at Figs. 1, 9, 11 and para. 0033, 0153-0156, 0161-0163). See MPEP § 2106.04(d)(I). See analysis, supra.
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.
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.
Claim(s) 1, 4-5, 8, 15, and 18-20 are rejected under 35 U.S.C. § 103 as being unpatentable over US 2020/0235909 A1 to Morimura et al. (“Morimura” herein).
Re. Claim 1, Morimura teaches a method, used in a distributed network system between a plurality of network nodes in a healthcare environment, to fulfill proof of value transactions according to a consensus contract, the network nodes being at least associated with one or more members in the healthcare environment that include patients, providers, and payers (Fig. 1, [0008] teach a healthcare information system 100 of computers 120, 130, 140 including servers, cloud-based systems, etc. [0087] teaches establishing transaction correctness and/or validity… by smart contract program code associated with a multi-dimensional blockchain. See also Fig. 8, [0038].), the method comprising
storing, in one or more databases of the distributed network system, (i) a plurality of intervention rules governed by the consensus contract, the intervention rules defining a plurality of interventions in response to events ([0044] teaches an EHR 200 may further comprise data fields Diagnosis 235, Diagnosis Code 240, Treatment Code 245 and Prescription Code 250. [0045] teaches EHR 200 for the patient may be stored as a blockchain with each transaction forming part of an information block / record… When a block is added to the blockchain, some data in the block may depend on other entities… Treatment Code 245 for a diagnosis may need approval and/or validation from Payer 140. See also [0101], [0110].), (ii) a plurality of valuation rules governed by the consensus contract, the valuation rules attributing a valuation for each of the members for the interventions ([0085] teaches a consensus technique may confirm the correctness of transactions that constitute the multi-dimensional block… A consensus technique such as a voting-based consensus technique may be used to determine if a multi-dimensional block 610 may be formed using blocks 520 and 540. When an authorized entity (e.g. Payer 140) or some specified number (e.g. a majority) of entities validates a transaction or block, then consensus is achieved. [0086] teaches If the transaction is confirmed as correct by the consensus technique, then a first instance of (unlocked) multi-dimensional block 610 may be formed. See also [0038], [0087]-[0088].), and (iii) a plurality of communication rules governed by the consensus contract, the communication rules defining a plurality of communications with each of the network nodes for the interventions (Figs. 1A, 7 and [0003], [0078] teach a transaction request may be sent out by an entity to relevant entities when a record is to be added to a blockchain maintained by the entity, e.g., using privacy rules pertaining to access. Fig. 7, [0121] teach storing the block with access permissions such that the block is accessible to appropriate entities associated with a permissioned private blockchain platform. [0101] teaches "smart contract" program code associated with the multi-dimensional blockchain may process transaction requests and determine the validity of transactions based on program logic that depends on the rules agreed to by the entities.);
building, with one or more processors of the distributed network system (processors 950), a distributed ledger for a given patient by ([0038] teaches “blockchain” refers to a growable list of records or “information blocks”, where the blocks are linked using cryptographic techniques, e.g., a cryptographic hash function mapping data of arbitrary size to a “hash”… the transaction data for a block may be represented as a Merkle tree root hash.):
receiving a given event for the given patient (Fig. 6B, [0066] teaches (b) an encrypted sub-block 485 (e.g. at the time of multi-dimensional block
formation) including information in fields Diagnosis 445, Diagnosis Code 450, Treatment Code 455, and repeating field Drug Code 460-1, 460-2 (received).);
adding the given event to the distributed ledger based on the communication rules ([0062] teaches data related to a transaction between HCP 120 and a patient and/or a patient and payer 140 may form part of HTR block 400 in the HTR blockchain (adding)… Diagnosis 445 information may be validated prior to block 400 being added to the HTR blockchain. [0118], [0121] teach the smart contracts layer requests validation from one or more entities associated with the permissioned private blockchain platform (based on the communication rules).);
selecting a given intervention, as a selected intervention, in response to the given event based on the intervention rules (Fig. 1, [0026] teach based on health information of the patient (the given event), HCP may determine patient insurance and proposed treatment information (selected).);
communicating the selected intervention, as a communicated intervention, to a given one of the network nodes based on the communication rules (Fig. 1, [0026] teach sending the patient insurance and proposed treatment information to Payer (node). [0118], [0121] teach the smart contracts layer requests validation from one or more entities associated with the permissioned private blockchain platform (based on the communication rules).);
receiving a record […], as a recorded intervention, in response to the communication ([0071] teaches a current information block 540 (received) being added to the blockchain maintained by Payer (in response to communication therewith) may comprise information that may be used to form sub-blocks 480 and 485. See [0066], Treatment Code 455.);
adding the recorded […] to the distributed ledger in response to the record ([0071] teaches a current information block 540 being added to the blockchain maintained by Payer may comprise information that may be used to form sub-blocks 480 and 485 (in response to the record). See [0066], Treatment Code 455.);
assessing one or more given valuations, as one or more assessed valuations, of the recorded […] for a given one or more of the members based on the valuation rules ([0038]-[0039] teach the transaction data for a block may be represented as a Merkle tree root hash (given valuations); that is, the data for the multi-dimensional block may include hashes of the individual data records that make up the multi-dimensional block. [0039] teaches a consensus mechanism between the entities may be used to confirm (assess) correctness of data in a proposed multi-dimensional block before the multi-dimensional block is committed and locked. [0038], [0077], [0084] teach validating prior to linking a record/block.); and
adding the one or more assessed valuations to the distributed ledger ([0039], [0077], [0084] teach subsequently obtaining an unlocked block and then committing and locking the formed block to any blockchain, e.g., locally in a blockchain and/or in an associated multi-dimensional blockchain.); and
configuring a settlement of the one or more assessed valuations for the given one or more of the members according to the consensus contract by distributing the distributed ledger in the distributed network system ([0039], [0077], [0084] teach subsequently obtaining an unlocked block and then committing and locking the formed block to any blockchain, e.g., locally in a blockchain and/or in an associated multi-dimensional blockchain. Fig. 6C, [0041], [0101]-[0102] teach the committed and locked multi-dimensional block has been shared (distributed) with corresponding authorized entities (distributed network system) using the rules or agreement between two or more entities in relation to data sharing, transactions, etc. encoded by the smart contract.)
Morimura fails to disclose an information block in two discrete blocks, such that a second separate information block of the communicated intervention is received.
The Examiner notes that a claim may be rendered obvious where the limiting function is that of making a set of prior-known elements contiguous, i.e., bringing them together; however, the opposite is also true. In this case, the limiting function is that of splitting prior-known elements or functionality into discrete elements: Splitting the information within sub-block 485 into a first multi-dimensional block and a second multi-dimensional block to be communicated in separate transaction requests. As such, this claim would additionally have been prima facie obvious to one of ordinary skill in the art before the effective filing date. See MPEP § 2144.04. Finally, it would be obvious to one of ordinary skill in the art before the effective filing date to make the information block / transaction request information separable without undue experimentation or risk of unexpected results. See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348,349 (CCPA 1961).
Re. Claim 4, Morimura teaches the method of claim 1, wherein the communication rules defining the communications with each of the network nodes for the interventions define how the distributed network system interfaces with each of the network nodes in sending and receiving the communications (Figs. 1A, 7 and [0003], [0078] teach a transaction request may be sent out by an entity to relevant entities when a record is to be added to a blockchain maintained by the entity, e.g., using privacy rules pertaining to access. Fig. 7, [0121] teach storing the block with access permissions such that the block is accessible to appropriate entities associated with a permissioned private blockchain platform. [0101] teaches "smart contract" program code associated with the multi-dimensional blockchain may process transaction requests and determine the validity of transactions based on program logic that depends on the rules agreed to by the entities. Fig. 6C, [0041], [0101]-[0102] teach the committed and locked multi-dimensional block has been shared with corresponding authorized entities using the rules or agreement between two or more entities in relation to data sharing, transactions, etc. encoded by the smart contract.)
Re. Claim 5, Morimura teaches the method of claim 1, wherein receiving the given event for the given patient (information in EHR block 200) comprises receiving a diagnosis for the given patient from a given provider (Diagnosis 235 or Diagnosis Code 240), thereby adding the diagnosis to the distributed ledger (see claim 1 prior art rejection).
Re. Claim 8, Morimura teaches the method of claim 1, wherein receiving the given event for the given patient (EHR information block 200) comprises receiving an observation of the given patient (Diagnosis 235), the given patient having a stated medical condition (Diagnosis Code 245), thereby adding the observation for the stated medical condition to the distributed ledger (see claim 1 prior art rejection).
Re. Claim 15, Morimura teaches the method of claim 1, wherein configuring the settlement by distributing the distributed ledger comprises:
adding data including the given event (the information block / EHR 200), the recorded intervention, and the one or more assessed valuations in blocks to the distributed ledger (see [0038]-[0039]) based on a consensus protocol (the consensus mechanism) dictating how to add or modify entries in the distributed ledger ([0039] teaches the consensus mechanism between the entities may be used to confirm (assess) correctness of data in a proposed multi-dimensional block (being added) before the multi-dimensional block is committed and locked. [0084] teaches if the information in sub-blocks… is determined to be incorrect or invalid (as outlined further below), then the transaction may be rejected… updated records may be rehashed (modified) after linking… Multi-dimensional blocks, unlocked or locked, may include data with a timestamp that… determines the order in which multi-dimensional blocks, once validated and finalized, are linked.); and
automatically fulfilling terms of the consensus contract in response to predefined conditions being met by coding terms of the consensus contract into code used in the distributed network system ([0041] teaches a “smart contract" program code or logic associated with a blockchain or a blockchain platform may encode the rules or agreement between the entities in relation to the data sharing, transactions, access, contract fulfillment, etc.)
Re. Claim 18, Morimura teaches the method of claim 1, wherein the providers include one or more of a hospital, a doctor, a medical supplier, etc.; wherein the payers include one or more of health management company, a medical insurer, an insurance company, a health plan administrator, etc.; wherein the events include one or more of: a medical-related event, a therapeutic-related event, a diagnosis, a medical observation, a consumption of a medical supply, hospitalization of a care-giver, and a change to a patient's circumstances like financial, housing, or food security; and wherein the interventions include one or more of a therapeutic protocol; a directed action, an adjustment to care plan, an educational material to raise condition literacy, an assistance to raise awareness about social program (like ride assistance or meal delivery), a delivery of a medical supply, and a reward for achieving therapeutic goals (like points programs, or reduced insurance cost) (see claim 1 prior art rejection).
Re. Claim 19, Morimura teaches a programmable storage device having program instructions stored thereon for causing one or more programmable network devices to perform a method of claim 1, used in a distributed network system between a plurality of network nodes, to fulfill transactions according to a consensus contract (see claim 1 prior art rejection. Fig. 1, [0008] teach a healthcare information system 100 of computers 120, 130, 140 including servers, cloud-based systems, etc. using computer-readable media or computer-readable memory. See also claim 26.)
Re. Claim 20, the subject matter of claim 20 is essentially defined in terms of a system, which is technically corresponding to claim 1. Since claim 20 is analogous to claim 1, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 1. Further, Morimura teaches one or more networks (para. 0025) and one or more interfaces (902, 906).
Claim(s) 2-3 and 16-17 are rejected under 35 U.S.C. § 103 as being unpatentable over Morimura in view of US 2025/0000361 A1 to Soori-Arachi.
Re. Claim 2, Morimura teaches the method of claim 1, wherein the intervention rules defining the interventions in response to the events […] (see claim 1 prior art rejection).
Morimura may not teach define how each of the events are detected and how the interventions are subsequently selected.
Soori-Arachi does teach
define how each of the events are detected and how the interventions are subsequently selected (Fig. 4, [0609] teach receiving a signal indicative of acquired sensor data; subsequently receiving a signal comprising data indicative of a diagnosis (detecting the event), an urgency level, and/or a recommendation (assigning an intervention); displaying the diagnosis, the urgency level, and/or the recommendation. [0288] teaches determining a diagnosis or a range of diagnoses using an AI feedback engine 334; and assigning the recommendation for each diagnosis using the AI feedback engine (necessitate defining how).)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date, to have modified the system and method for healthcare security and interoperability of Morimura to incorporate rules or instructions for outputting a diagnosis event and subsequently determining a treatment recommendation for the diagnosis and to use this information as part of an AI-enabled multi-sensor connected telehealth system as taught by Soori-Arachi (see at least para. 0288), with the motivation of improving patient monitoring, decision support, and data security (see Soori-Arachi at para. 0002, 0018, 0023).
Re. Claim 3, Morimura teaches the method of claim 1, wherein the valuation rules attributing the valuation for each of the given one or more members for the interventions […] (see claim 1 prior art rejection).
Morimura may not teach define how the recorded interventions are detected and how the recorded interventions are subsequently valued.
Soori-Arachi does teach
define how the recorded interventions are detected and how the recorded interventions are subsequently valued (Fig. 4, [0609] teach receiving a signal indicative of acquired sensor data; subsequently receiving a signal comprising data indicative of a diagnosis, an urgency level, and/or a recommendation. [0288] teaches the AI feedback engine 334 may take as input health states and/or conditions… each entry in the range of diagnoses may comprise a degree of certainty… The AI feedback engine 334 may assign an urgency level associated with the most urgent entry or the most likely entry… and may assign a recommendation associated with the most urgent entry or the most likely entry (necessitates defining how the recommendation is detected and how the recommendation is subsequently valued as a priority).)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date, to have modified the system and method for healthcare security and interoperability of Morimura to incorporate rules or instructions for determining a range of diagnoses events, associated urgency or likelihood for each diagnosis, associated treatment recommendation for each diagnosis and subsequently outputting a treatment recommendation for the most urgent or likely diagnosis and to use this information as part of an AI-enabled multi-sensor connected telehealth system as taught by Soori-Arachi (see at least para. 0288), with the motivation of improving patient monitoring, decision support, and data security (see Soori-Arachi at para. 0002, 0018, 0023).
Re. Claim 16, Morimura teaches the method of claim 1, wherein to assess the one or more assessed valuations, the method comprises […] (see claim 1 prior art rejection).
Morimura may not teach using an artificial intelligence (Al) model.
Soori-Arachi does teach using an artificial intelligence (AI) model ([0288] teaches determining a diagnosis or a range of diagnoses using an AI feedback engine 334; and assigning the recommendation for each diagnosis using the AI feedback engine.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date, to have modified the system and method for healthcare security and interoperability of Morimura to incorporate artificial intelligence module(s) and to use this information as part of an AI-enabled multi-sensor connected telehealth system as taught by Soori-Arachi (see at least para. 0288), with the motivation of improving patient monitoring, decision support, and data security (see Soori-Arachi at para. 0002, 0018, 0023).
Re. Claim 17, Morimura/Soori-Arachi teaches the method of claim 16, wherein to use the Al model, the method comprises: training the Al model to score a plurality of interventions based on performance metrics (Soori-Arachi Fig. 4, [0609] teaches receiving a signal indicative of acquired sensor data; subsequently receiving a signal comprising data indicative of a diagnosis, an urgency level, and/or a recommendation. Soori-Arachi [0288] teaches the AI feedback engine 334 may use the totality/trend over time of health states and/or conditions to determine a range of diagnoses entries… each entry may comprise a degree of certainty (score), e.g., urgency, … The AI feedback engine 334 may assign an urgency level to each diagnosis… may assign a recommendation (intervention) to each diagnosis… and may assign a recommendation associated with a most urgent entry. [0292] teaches the urgency level may comprise a number from 1 to 5; and the recommendation may comprise initiating a call with a telemedicine physician. Soori-Arachi [0053] teaches the AI model is trained.); and informing the step of assessing the one or more given valuations (see claim 1 prior art rejection) based on the scoring by the Al model (see previous citations of Soori-Arachi) to formulate the one or more assessed valuations for the given one or more of the members (see claim 1 prior art rejection).
Subject Matter Free of Prior Art
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within claim 6 (and its dependent claim 7) as follows:
a digital therapeutic program, and
receiving comprise[s] receiving a consent from the given patient to the digital therapeutic program, as the record, in response to the communication; and adding an indication of the digital therapeutic program, as the recorded intervention, to the distributed ledger in response to the consent.
The most remarkable prior art of record is as follows:
US 2020/0235909 A1 to Morimura for teaching a system and method for healthcare security and interoperability (see Abstract).
US 2024/0070627 A1 to Galterio for teaching a Consensus technique achieved via patient consent (necessarily received) because consumers have a say in what is done (i.e., to them) (see Fig. 1).
US 2025/0195762 A1 to Corbett for teaches receiving an indication of positive patient verification with the injection device unlocking subsequently (para. 0265-0266); receiving data collected from an intelligent injection device 400 (see para. 0136) with the intelligent injection device microprocessor 510 recording the injection administration completion event (i.e., a completed digital therapeutic program) and sending the administration data 800 over a wireless module 504 (see Fig. 5E and para. 0241).
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within claim 9 (and its dependent claim 10) as follows:
selecting a directed action for the given patient to contact a given provider,
communicating the directed action,
receiving an indication of completion of the directed action… in response to the communication, and
adding the indication of completion of the directed action... in response to indication.
Similarly, to claims 9-10, the cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within claim 11 (and its dependent claim 12) as follows:
selecting a directed action for a given provider,
communicating the directed action,
receiving an indication of completion of the directed action in response to the communication; and
adding the indication of completion of the directed action… in response to the indication.
The most remarkable prior art of record is as follows:
US 2020/0235909 A1 to Morimura for teaching a system and method for healthcare security and interoperability (see Abstract).
US 2024/0070627 A1 to Galterio for teaching a Consensus technique achieved via patient consent (necessarily received) because consumers have a say in what is done (i.e., to them); and (see Fig. 1).
US 2025/0000361 A1 to Soori-Arachi for teaching an AI enabled multi-sensor connected telehealth system with an AI feedback engine 334 that determines one or more diagnoses, one or more urgency levels, one or more treatment recommendations; and optionally assigning a recommendation (i.e., directed action) associated with the most urgent diagnosis entry in the range of diagnoses for subsequent display; and the recommendation may comprise initiating a call with a telemedicine physician (see Abstract, Fig. 4, para. 0288, 0292).
US 2025/0195762 A1 to Corbett for teaching receiving an indication of a positive patient verification (completion of an action) (see para. 0265-0266).
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within claim 13 (and its dependent claim 14) as follows:
selecting a therapeutic reward for the given patient… by measuring the observation… against a threshold goal based on the intervention rules for the stated medical condition,
communicating the therapeutic reward… to the given patient,
receiving an indication of the therapeutic reward… in response to the communication, and
adding the therapeutic reward… in response to the indication.
The most remarkable prior art of record is as follows:
US 2020/0235909 A1 to Morimura for teaching a system and method for healthcare security and interoperability (see Abstract).
US 2024/0070627 A1 to Galterio for teaching to take a trigger point and use its data in the payment, compared against a submission (para. 0299); and a registry taking clinical codes from the patient charge along with other clinical data from the provider’s systems, equating these data to Quality Measures” (para. 0302).
US 2025/0195762 A1 to Corbett for teaches receiving an indication of positive patient verification with the injection device unlocking subsequently (para. 0265-0266); receiving data collected from an intelligent injection device 400 (see para. 0136) with the intelligent injection device microprocessor 510 recording the injection administration completion event (also a type of indication) and sending the administration data 800 over a wireless module 504 (see Fig. 5E and para. 0241).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
WO-2024148028-A1 to Robell et al. for teaching technologies for creating non-fungible tokens for electronic health records: An EHR NFT service receives a set of user data items associated with a user, and verifies each user data item of the set of user data items. The EHR NFT service generates a set of hashes, wherein each hash in the set of hashes corresponds to a verified user data item in the set of user data items. The EHR NFT service mints an EHR NFT that includes each hash in the set of hashes and updates a smart contract to include the EHR NFT. Other embodiments may be described and/or claimed.
US 20230360779 A1 to GNANASAMBANDAM et al. for teaching SYSTEMS AND METHODS FOR USING A DISTRIBUTED LEDGER TO MANAGE KNOWLEDGE IN A HEALTHCARE ECOSYSTEM.
US 20230268042 A1 to Sebastian et al. for teaching blockchain based healthcare management network.
US 20220384027 A1 to Kaleal, III et al. for teaching TRACKING AND REWARDING HEALTH AND FITNESS ACTIVITIES USING BLOCKCHAIN TECHNOLOGY.
US 20190117070 A1 to Muhsin et al. for teaching a medical monitoring system.
US 20140207486 A1 to Carty et al. for teaching a health management system (see Fig. 1).
US 20250378923 A1 to Macoviak for teaching Remotely-Executed Medical Diagnosis And Therapy Including Emergency Automation (see Figs. 1, 5, 23, 25, 35, 39-41).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica M Webb whose telephone number is (469)295-9173. The examiner can normally be reached Mon-Thurs 9:30am-3:30pm CST.
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/J.M.W./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683
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