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 .
Status of the Claims
The office action is in response to the claims filed on September 11, 2025 for the application filed September 11, 2025 which claims priority to a provisional application filed on September 11, 2024. Claims 1-20 are currently pending and have been examined.
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 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to one or more computer-readable media encompasses transitory forms of signal transmission (often referred to as "signals per se"), such as a propagating electrical or electromagnetic signal or carrier wave
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.
Eligibility Step 1:
Under step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, claims 1-13 are directed towards a method (i.e. a process), which is a statutory category. Claims 14-16 are directed towards a system (i.e. a machine), which is a statutory category. Assuming claims 17-20 are amended such that they are also directed toward a statutory category, it must be determined if the claims are directed towards a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea). In the instant application, the claims are directed towards an abstract idea.
Eligibility Step 2A, Prong One:
Under step 2A, prong one of the 2019 Revised Patent Subject Matter Eligibility Guidance, independent claims 1, 14 and 17 are determined to be directed to an judicial exception because an abstract idea is recited in the claims which fall within the subject matter groupings of abstract ideas. The abstract idea (identified in bold) recited in the representative claim 14 is identified as:
A system, comprising:
a memory having instructions stored thereon; and
a processor configured to execute the instructions to cause the system to:
receive, from a mobile application associated with a user, first health data comprising at least one of a prescription indicator or a user-reported health metric;
receive, from at least one wearable device associated with the user, second health data comprising at least one physiological measurement;
receive, from at least one external health record data source, third health data associated with the user;
aggregate the first health data, the second health data, and the third health data into a Consumer Health Record (CHR); and
facilitate, via a secure data exchange system, a bi-directional exchange of at least a portion of the CHR with an external healthcare system based on governance rules set by the user.
The identified limitations fall within the subject matter grouping of certain methods of organizing human activity related and the sub grouping of managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions), commercial or legal interactions (including agreements in the form of contracts, legal obligations). The claim as a whole recites a method of organizing human interactions. The claimed invention is a method that allows a user to aggregate and exchange patient medical records with others based on governance rules set by a user, which is a method of managing interactions between people. Exchanging based on governance rules set by the user is also a method of organizing a legal interaction.
Accordingly, claims 1, 14 and 17 recite an abstract idea under step 2A, prong one.
Eligibility Step 2A, Prong Two:
Under step 2A, prong two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the identified abstract ideas are integrated into a practical application. After evaluation, there is no indication that any additional elements or combination of elements integrate the abstract idea into a practical application, such as through: an additional element that reflects an improvement to the functioning of a computer, or an improvements to any other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element that implements the judicial exception with, or uses the judicial exception in connection with, a particular machine or manufacture that is integral to the claim; an additional element that effects a transformation or reduction of a particular article to a different state or thing; or an additional element that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. As shown below, the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than a recitation of: generally linking the abstract idea to a particular technological environment or field of use; insignificant extra-solution activity to the judicial exception; and/or adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea as evidenced below.
The additional elements recited in representative claim 14 are identified in italics as:
A system, comprising:
a memory having instructions stored thereon; and
a processor configured to execute the instructions to cause the system to:
receive, from a mobile application associated with a user, first health data comprising at least one of a prescription indicator or a user-reported health metric;
receive, from at least one wearable device associated with the user, second health data comprising at least one physiological measurement;
receive, from at least one external health record data source, third health data associated with the user;
aggregate the first health data, the second health data, and the third health data into a Consumer Health Record (CHR); and
facilitate, via a secure data exchange system, a bi-directional exchange of at least a portion of the CHR with an external healthcare system based on governance rules set by the user.
The additional limitations of “a memory…”, “a processor…”, “one or more computer-readable media…”, “via a secure data exchange system” and “with an external healthcare system” are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f). The claimed computer components are recited at a high level of generality and are merely invoked as tools to perform an existing medical record aggregation and exchange process. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea. Therefore, these additional elements amount to no more than a recitation of the words "apply it" (or an equivalent) or no more than mere instructions to implement an abstract idea or other exception on a computer or no more than merely using a computer as a tool to perform an abstract idea.
The additional limitations of “receive… data” are determined to be no more than insignificant extra-solution activity to the judicial exception under MPEP §2106.05(g). Receiving data in order to aggregate and exchange the data is mere necessary data gathering required by the recited abstract idea.
Accordingly, claims 1, 14 and 17 do not recite additional elements which integrate the abstract idea into a practical application.
Eligibility Step 2B:
Under step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether provide an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. After evaluation, there is no indication that an additional element or combination of elements 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 limitations amount to mere instructions to apply an abstract idea under MPEP §2106.05(f) and insignificant extra-solution activity to the judicial exception under MPEP §2106.05(g), which does not amount to significantly more than the abstract idea. Evidence that receiving data is well understood, routine and conventional is provided by MPEP §2106.05(d), subsection II.
Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements amounts to an inventive concept.
Dependent Claims:
The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above. None of these limitations are deemed to integrate the claims into a practical application or to amount to significantly more than the abstract idea as detailed below.
Regarding claim 2, providing a read-only view of the CHR to a healthcare provider is determined to be directed to a method of organizing human interactions, such as the interaction of providing healthcare records between a user and a healthcare provider.
Regarding claim 3, receiving data from an EMR or EHR in order to aggregate and exchange the data is determined to be the insignificant extra-solution activity to the judicial exception of mere necessary data gathering under MPEP §2106.05(g).
Regarding claim 4, tracking medication adherence based on data from a pharmacy is determined to be directed to organizing the human activity of medication adherence tracking. The use of a POS system to exchange data is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f).
Regarding claim 5, generating a personalized care plan based on analyzing the CHR is determined to be directed to organizing the human activity of care plan generation and a mental process, as analyzing data to generate/determine a care plan can be performed in the mind using observations, evaluations, judgments and opinions. The use of AI or a machine learning algorithm is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f).
Regarding claim 6, predicting a potential medication side effect is determined to be directed to the abstract idea grouping of mental processes.
Regarding claim 7, transmitting the care plan to provider or pharmacist is determined to be directed to organizing human interactions. Furthermore, transmitting data is the insignificant extra-solution activity to the judicial exception of data outputting under MPEP §2106.05(g), which is well understood, routine and conventional as evidenced by MPEP §2106.05(d), subsection II.
Regarding claim 8, initiating exchanged by a QR code or a web portal is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f) as the claim only recited to outcome of initiating without any details as to how the initiating is accomplished by the QR code or web portal.
Regarding claim 9, determining governance rules and facilitating modification, by the user, of data sharing permissions is determined to be directed to organizing human interactions and legal interactions. The used of a dynamic consent management systems is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f).
Regarding claim 10, defining the governance rules is determined to be encompassed by the abstract idea of claim 1.
Regarding claim 11, generating granular analytics based on the CHR is determined to be directed to a mental process.
Regarding claim 12, maintaining an audit trail of transaction related to exchange of the CHR is determined to be directed to organizing commercial or legal interactions. The use of a blockchain component is determined to be ere instructions to apply an abstract idea under MPEP §2106.05(f).
Regarding claim 13, opting in to data sharing agreements to share de-identified data is determined to be directed to organizing commercial or legal interactions.
Regarding claim 15, facilitating medication distribution based on crowdsourcing is determined to be directed to organizing commercial or legal interactions.
Regarding claim 16, sharing health data during a consultation is determined to be directed to organizing human interactions. Limiting the sharing to remote users and telehealth systems during virtual consultations is determined to be no more than generally linking the use of a judicial exception to a particular technological environment or field of use under MPEP §2106.05(h).
Regarding claim 18, receiving genomics data is determined to be the insignificant extra-solution activity to the judicial exception of data gathering under MPEP §2106.05(g), which is well understood, routine and conventional as evidenced by MPEP §2106.05(d), subsection II. Aggregating the data and providing drug interaction predictions is determined to be directed to organizing human interactions. Generating drug interaction predictions based on the genomics data is also directed to a mental process.
Regarding claim 19, transmitting a drug recall notification to a user or physician is determined to be directed to organizing human interactions.
Regarding claim 20, notification a accountability partner by the user based on the a medication adherence metric is determined to be directed to organizing human interactions. The use of SMS is determined to be no more than generally linking the use of a judicial exception to a particular technological environment or field of use under MPEP §2106.05(h).
Therefore, whether taken individually or as an ordered combination, 1-20 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9, 11, 14-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neagle (U.S. Pub. No. 2018/0358177).
Regarding claim 1, Neagle discloses a method, comprising:
receiving, from a mobile application associated with a user, first health data comprising at least one of a prescription indicator or a user-reported health metric (Paragraph [0018], The system 10 is patient-centric resource that puts the patient's comprehensive and up-to-date health and wellness data easily within reach of the patient, such as via a software application or app 13 executing on a computing device 12 such as a mobile telephone, tablet computer, laptop computer, desktop computer, or other suitable computing devices in existence now or developed later. Paragraph [0021], The patient comprehensive health and wellness data 14 include information relating to medicines and supplements, such as medical history, active medicines, compliance data, reminders, ineffective medicine, and side effects. The patient health and wellness data 14 also include information about the healthcare providers, pharmacies, dependent sub-accounts, allergies, vaccination record, lifestyle and exercise data, dietary data, laboratory data, imaging data, medical charts, past, current (including automatically monitored) and future health/physiological parameters (heart rate, blood pressure, body temperature, perspiration, glucose level, blood oxygen level, risky addiction or behavior such as smoking cessation monitoring), diagnostics, HIPAA and security, legal document data (living will, do not resuscitate directives, power of attorney, etc.), and insurance data. Paragraph [0022], These comprehensive health and wellness data may originate from a wide variety of sources 18. Additionally, the patient may enter data. Also see paragraph [0050] and [0055] and claim 1.);
receiving, from at least one wearable device associated with the user, second health data comprising at least one physiological measurement (Paragraph [0022]. These comprehensive health and wellness data may originate from a wide variety of sources 18. Further, the patient may wear monitoring devices that automatically measure and wireless transmit physiological parameters. Also see paragraphs [0027], [0043] and [0057] and claim 1.);
receiving, from at least one external health record data source, third health data associated with the user (Abstract, The system further includes an external connect interface adapted to interface with external systems and applications for receiving health and wellness data associated with the patient. Paragraph [0022], These comprehensive health and wellness data may originate from a wide variety of sources 18, including, in no particular order, physical therapists, emergency first responders, healthcare providers, pharmacies, hospitals, emergency rooms, acute care facilities, laboratories, outpatient surgery centers, dieticians, benefits manager and insurer content management systems, and third party live data analysis systems.);
aggregating the first health data, the second health data, and the third health data into a Consumer Health Record (CHR) (Claim 1, a data aggregator configured to interface with a plurality of external disparate data sources to import health and wellness data associated with the patient for storing in the health and wellness data record in the database. Paragraph [0024], Preferably, all of a patient's data is wholly contained in a single record. Paragraph [0045], A patient's data may be organized as a single record that may consist of multiple documents.); and
facilitating, via a secure data exchange system, a bi-directional exchange of at least a portion of the CHR with an external healthcare system based on governance rules set by the user (Abstract, A system for a patient-centric personal health information exchange comprises a database operable to store a health and wellness data record associated with a patient/data owner, an access management system that strictly controls access to the health and wellness data record stored in the database according to access rules set by the patient, a web interface to interface with healthcare providers submitting requests for access to the health and wellness data, and mobile apps serving as interfaces for the patient, family members, care team, and emergency first responder to access and supply the data. Also see figs. 15-16.).
Regarding claim 2, Neagle further discloses wherein facilitating the bi-directional exchange comprises providing a read-only view of the CHR to a healthcare provider associated with the external healthcare system (Claim 1, an access management system configured to strictly control access to the health and wellness data record stored in the database according to access rules set by the patient, the access rules authorizing different levels of read and write permissions. Paragraph [0070], The personal health information exchange 10 receives, stores, and provides authorized access to three primary types of entities: patient and family members/caregivers 270, first responders such as emergency first responders 272, and healthcare providers 274 associated with healthcare organizations 276 such as clinics and hospitals.).
Regarding claim 3, Neagle further discloses wherein the at least one external health record data source comprises at least one of an electronic medical record (EMR) system or an electronic health record (EHR) system (Paragraph [0068], The personal health information exchange 10 also imports searchable data from multiple sources 240, including EMRs 242, EMR aggregators 244, other health information exchanges 246, laboratories 248, and pharmacy databases 250.).
Regarding claim 4, Neagle further discloses wherein the external healthcare system comprises a pharmacy Point-of-Sale (POS) system, the method comprising: tracking medication adherence based on data exchanged with the pharmacy POS system (Paragraph [0053], In block 116, the system 10 receives a notification from the pharmacy when the medication has been picked up by the patient. The system 10 may set a time limit as to when the medication should have been picked up, such as three days, for example. The system 10 may also send reminders to the patient if pick up has not occurred within a specific timeframe. Similarly, refill reminders may also be sent. If the medication is picked up within this pre-set time frame, then the system documents compliance in block 118. Otherwise, the non-compliance is documented and a notification is transmitted to the physician that prescribed the medication in blocks 120 and 122. Paragraph [0068], The personal health information exchange 10 also imports searchable data from multiple sources 240, including EMRs 242, EMR aggregators 244, other health information exchanges 246, laboratories 248, and pharmacy databases 250.).
Regarding claim 5, Neagle further discloses: generating a personalized care plan based on analyzing the CHR using at least one of an artificial intelligence (AI) or a machine learning algorithm (Paragraph [0067], A care plan engine 236 is configured to analyze the output from the analytic engine and the patient's clinical and non-clinical data to automatically formulate and propose a care plan for the patient to address symptoms, diseases, etc. The care plan is devised with input from the physician, care team, databases, risk stratification, artificial intelligence, and predictive analysis, and must be approved by the appropriate healthcare provider.).
Regarding claim 6, Neagle further discloses wherein analyzing the CHR comprises: predicting a potential medication side effect (Paragraph [0066], An analytic engine 234 is configured to determine the patient's risk for certain diseases and illnesses and rank or stratify the patient's risk in comparison to other patients in the system. The analytic engine 234 may incorporate artificial intelligence, knowledge-based technology, predictive models, and other advanced techniques. The analytic engine 234 may also identify trends in aggregated patient data associated with a patient population, such as risk stratification, compliance efficacy, pharmaceutical side effects, and cost of treatment. Paragraph [0064], The reconcile prescription data module 232 may automatically check the patient's medications for medication and dosage discrepancies, adverse interactions with other medications and supplements, allergies, side effects, and ineffectiveness, and to flag any issue with notification to the patient, caregiver and/or healthcare provider.).
Regarding claim 7, Neagle further discloses wherein facilitating the bi-directional exchange comprises: transmitting the personalized care plan to at least one of a healthcare provider or a pharmacist (Paragraph [0064], The care plan for the patient may be automatically updated in response to actionable data, provider input, alerts and notifications, analytics engine output (monitored vitals, medication compliance, risk stratification, etc.). Healthcare providers such as physicians, physician assistants, and nurses may be provided access to the data via their dedicated portal 230. Also see paragraph [0068].).
Regarding claim 8, Neagle further discloses wherein facilitating the bi-directional exchange is initiated via at least one of a quick response (QR) code or a web portal (Paragraph [0072], An emergency medical personnel who has pre-registered as a user would be able to access the health and wellness data in the PHIE system 10, such as chronic conditions/diseases, medications, allergies, DNR directives, etc. When such user attempts to gain access to the data, by using or scanning the ID button 190 (FIGS. 10-12) and other devices employing NFC, QR, etc. worn by the patient, for example, the system 10 automatically provides the emergency personnel an emergency contact for the patient/data owner, enables access to the patient's data, and notifies the patient's care team member. Paragraph [0050], The system 10 may provide third parties such as physicians and pharmacies dedicated portals for accessing the patient data.).
Regarding claim 9, Neagle further discloses determining the governance rules based on accessing a dynamic consent management system that facilitates modification, by the user, of data sharing permissions (Paragraph [0030], The patient may easily set up data access permissions and terminate permissions. Paragraph [0047], The user may also provide information about persons who have permission to access the data, as shown in block 66. The user may enter specific information about the permitted users along with their names and ID, methods of access, password, and what subsets of data is available to each permitted user. Paragraph [0049], the patient/data owner may, at any time, accept or terminate an information sharing arrangement with a healthcare provider or institution.).
Regarding claim 11, Neagle further discloses: generating granular analytics based on the CHR, the granular analytics comprising at least one of a health trend insight, a goal setting monitor, or a data-driven engagement tool (Paragraph [0059], tracking, monitoring, and trend analysis may also be performed and the results presented to the user. Paragraph [0064], The challenge engine 220, incentive engine 221, and behavior modification engine 222 can be deployed to help the patient to set personal goals and challenges, provide incentives for attaining the personal goals, to change bad or unhealthful behavior, and to comply with the prescribed care plan. Paragraph [0033], The fitness & challenge module 37 provides a way to motivate users to reach certain nutrition, fitness, medication compliance, and biometric assessment goals. Paragraph [0034], The compliance & engagement module 38 tracks the patient's medicine and supplement intake and encourages compliance with the doctor's prescription and orders.).
Regarding claim 14: all limitations as recited have been analyzed and rejected with respect to claim 1. Claim 14 pertains to a system, corresponding to the method of claim 1. Claim 14 does not teach or define any new limitations beyond claim 1 apart from the processor and memory disclosed by Neagle in figure 2; therefore claim 14 is rejected under the same rationale.
Regarding claim 15, Neagle further discloses wherein the processor is configured to execute the instructions to cause the system to:
facilitate medication distribution based on a crowdsourcing model (Paragraph [0037], The interaction process module 41 enables the patient and caregivers to automatically check drug prescriptions for possible allergies, side effects, ineffective medications, and interactions, as well as interactions with food and supplements, against the patient's health record. The module may consult external databases (Surescripts) and other knowledge bases. This module 41 automatically looks up external and/or internal databases for any known interactions between drugs, supplements, and food. This module may generate actionable data that are relayed to the care team to address reconciliation issues as well as approve new medications/supplements. Paragraph [0066], The analytic engine 234 may also identify trends in aggregated patient data associated with a patient population, such as risk stratification, compliance efficacy, pharmaceutical side effects, and cost of treatment. Also see claim 1, an analytic engine configured to analyze the health and wellness data and identified risk, and identify actionable data. Identifying pharmaceutical side effects trends in aggregated patient data associated with a patient population to check for side effects in new medications for a patient before approval is construed as facilitating medication distribution based on a crowdsourcing model.).
Regarding claim 16, Neagle further discloses wherein, to facilitate the bi-directional exchange, the processor is configured to execute the instructions to cause the system to:
facilitate remote user monitoring by sharing the second health data with a telehealth system during a virtual consultation (Paragraph [0038], The care team may communicate health plan updates and other changes using a variety of methods (phone call, email, text, video conference, augmented reality, virtual reality, etc.) to push the information to the patient and caregivers to ensure compliance. Paragraph [0064], The personal health information exchange 10 receives, stores, and provides access to patient interface data 200 (include real-time monitoring data).).
Regarding claim 17: all limitations as recited have been analyzed and rejected with respect to claim 1. Claim 17 pertains to a computer-readable media, corresponding to the method of claim 1. Claim 17 does not teach or define any new limitations beyond claim 1 apart from the computer-readable media disclosed by Neagle in paragraph [0024]; therefore claim 17 is rejected under the same rationale.
Regarding claim 20, Neagle further discloses:
transmitting a short message service (SMS) notification to an accountability partner designated by the user based on a medication adherence metric derived from the CHR (Paragraph [0025], The system may issue a warning message if certain restraints are violated. For example, a warning may be given (e.g., displayed, audio message, text message, etc.) if a medication reminder is within 30 minutes of a supplement reminder. The health parameter thresholds may be set by a healthcare provider for a particular patient, or set generally for all patients with a certain condition, for example. Paragraph [0038], The care team may communicate health plan updates and other changes using a variety of methods (phone call, email, text, video conference, augmented reality, virtual reality, etc.) to push the information to the patient and caregivers to ensure compliance. Paragraph [0071], The care app 280 is also the user interface for delivery of reminders to the patient and caregivers for scheduled appointments, medication compliance, and prescription refills, for example. Paragraph [0073], A third group of users include healthcare providers such as primary care physicians, secondary providers, dieticians, and case managers 274. These caregivers/users, when authorized by the patient (or guardian of the patient), may access data associated with the patient in the personal health information exchange system 10 by using a med application 284. These care providers 274 may also supply information about the patient's condition and status to the system 10. If desired by the patient, alerts and notifications about the patient's condition, medication compliance, the patient's vitals measurements, and other status information can be sent to these healthcare providers.).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Neagle (U.S. Pub. No. 2018/0358177) in view of Curbera at al. (U.S. Pub. No. 2018/0082024).
Regarding claim 10, Neagle does not appear to explicitly disclose, but Curbera teaches that it was old and well known in the art of healthcare data platforms at the time of the filing wherein the governance rules comprise an expiration date for data access (Curbera, paragraph [0114], the patient 310 grants consent for releasing patient information and provides location information, e.g., identifying a health provider that stores or holds the patient information (referred to also as a “releasing institution”), e.g., health system 340 in FIG. 4, and patient information characteristics (step 1 in FIG. 4). For example, this information may comprise a data structure specifying the health provider to which consent is granted, the terms of the consent, e.g., time limitations, date limitations, usage limitations, etc.) to provide efficient access to a patient’s medical records and protect the privacy of patient's medical records (Curbera, paragraphs [0002]-[0003]) .
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data platforms at the time of the filing to modify the method of Neagle to such that the governance rules comprise an expiration date for data access, as taught by Curbera, in order to provide efficient access to a patient’s medical records and protect the privacy of patient's medical records.
Regarding claim 12, Neagle further discloses maintaining, Paragraph [0044], The audit database may store record change logs, system logs, and other audit data that may be necessary to ensure HIPAA compliance, for example.), but does not appear to explicitly discloses using a blockchain component.
Curbera teaches that it was old and well known in the art of healthcare data platforms at the time of the filing to use a blockchain component to maintain an audit trail of patient data transactions (Cubera, paragraph [0110], provide a more secure and auditable solution for controlling access to patient information, which instills greater trust by health providers and patients. The tamper-proof and immutable ledgers 223, such as may be generated using blockchain technology for example, are the system of record for all health care based patient information transactions inside the health blockchain network. Health participants consent to verified health related transactions. Smart contracts are used to capture health related compliances and conditional logic requirements. Transactions may be embedded into distributed databases and self-executed with each transaction. Privacy is achieved by ensuring each member has the proper level of viability, and health related transactions are maintained secure.) to enable a secure medical information exchange hub that controls and secures exchange of medical, health, pharmacy and fitness information, also referred to herein as patient information, ensuring compliance and auditability of patient information releases (Curbera, paragraph [0139], enable a secure medical information exchange hub that controls and secures exchange of medical, health, pharmacy and fitness information, also referred to herein as patient information, ensuring compliance and auditability of patient information releases.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data platforms at the time of the filing to modify the maintain of an audit trail of Neagle to use a blockchain component, as taught by Curbera, in order to enable a secure medical information exchange hub that controls and secures exchange of medical, health, pharmacy and fitness information, also referred to herein as patient information, ensuring compliance and auditability of patient information releases.
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Neagle (U.S. Pub. No. 2018/0358177) in view of Dukatz (U.S. Pub. No. 2017/0091389).
Regarding claim 13, Neagle does not appear to explicitly disclose, but Dukatz teaches that it was old and well known in the art of healthcare data platforms at the time of the filing to include providing, via a governance rule setting, an option for the user to opt-in to a data-sharing agreement with an industry partner in exchange for compensation, wherein data shared with the industry partner is de-identified (Dukatz, Paragraph [0048], The user interface 500 includes a requested data section 510. The requested data section 510 lists the healthcare related data that the third party is requesting and provides radio buttons for the patient to share the data or not share the data. Paragraph [0051], The user interface 500 includes compensation section 555. The compensation lists the compensation that is provided to the user by the third party for sharing healthcare related data with the third party. Paragraph [0052], The user interface 500 includes participation agreement section 557. The participation agreement section 557 includes a participation agreement view button 560, a participation accept button 565, and a participation decline button 570. Paragraph [0064], The system receives, from the user, data indicating an acceptance of the request for access to the user's personal healthcare related data that is shared with the healthcare provider and data indicating a level of abstraction to apply to the user's personal healthcare related data that is shared with the healthcare provider (740). The level of abstraction applied by the user allows the user to select the personal healthcare related data to share with the third party. For example, the user may select to share the user's gender and geographic location, but request that the system remove the user's name and age.) to solicit volunteers to participate in a research study so that the healthcare researcher can gather data (Dukatz, paragraph [0003]).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data platforms at the time of the filing to modify the method of Neagle to include providing, via a governance rule setting, an option for the user to opt-in to a data-sharing agreement with an industry partner in exchange for compensation, wherein data shared with the industry partner is de-identified, as taught by Dukatz, in order to solicit volunteers to participate in a research study so that the healthcare researcher can gather data.
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Neagle (U.S. Pub. No. 2018/0358177) in view of Gostyla et al. (U.S. Pub. No. 2020/0135314).
Regarding claim 18, Neagle does not appear to explicitly disclose, but Gostyla teaches that it was old and well known in the art of medication management at the time of the filing to include:
receiving fourth health data comprising consumer genomics data (Gostyla, Abstract, creating a user profile based at least upon received user genetic information.);
aggregating the fourth health data into the CHR (Gostyla, paragraph [0024], combines a user's personal medical and proprietary genetic information with current scientific and medical information, including real-time, newly discovered medical and medication information received from one or more databases, to create a user profile.); and
providing a personalized medicine insight based on the consumer genomics data, the personalized medicine insight comprising a drug interaction prediction (Gostyla, paragraph [0037], Based on this received information, data management system is able to determine whether there are any interactions or conflicts that the patient should be concerned with. These conflicts could be conflicts between two or more drugs, a drug and a patient's illness, a drug and an allergy, a drug and food and/or beverage being taken by the patient, between a drug and some aspect of the patient's lifestyle, and a drug and the genetic makeup of the patient. Also see figure 10.) to prevent additional healthcare issues and possibly death from medication (Gostyla, paragraph [0003]).
Therefore, it would have been obvious to one of ordinary skill in the art of medication management at the time of the filing to modify the operations of Neagle to include receiving fourth health data comprising consumer genomics data; aggregating the fourth health data into the CHR; and providing a personalized medicine insight based on the consumer genomics data, the personalized medicine insight comprising a drug interaction prediction, as taught by Gostyla, in order to prevent additional healthcare issues and possibly death from medication.
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Neagle (U.S. Pub. No. 2018/0358177) in view of Do (U.S. Pub. No. 2020/0357499).
Regarding claim 19, Neagle does not appear to explicitly disclose, but Do teaches that it was old and well known in the art of prescription processing at the time of the filing to include transmitting a drug recall notification to at least one of the user or a prescribing physician based on the CHR (Paragraph [0130], the prescription system 110 can cause a processor of the computing device 120 to generate an alert for warning a patient. For example, the prescription system 110 may receive a warning or medical product recall from an external server 150, which may be associated with a patient advocacy group, health organization, medical product manufacturer, or government organization. The prescription system 110 can determine the medical product identifier associated with the medical product and transmit an alert to patients associated with the medical product identifier via computing devices 12.) to improve the patient safety and satisfaction (Do, paragraph [0131]).
Therefore, it would have been obvious to one of ordinary skill in the art of prescription processing at the time of the filing to modify the operations of Neagle to include transmitting a drug recall notification to at least one of the user or a prescribing physician based on the CHR, as taught by Do, in order to improve the patient safety and satisfaction.
Conclusion
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/DEVIN C HEIN/Examiner, Art Unit 3686
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