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 .
1. Claims 1 – 20 are currently pending in this application.
NOTE: it is recommended that the applicant contact the examiner to discuss the case prior to submitting a response.
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 they are directed towards non-statutory subject matter.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. When considering subject matter eligibility under 35 U.S.C. 101, it must be determined whether the claim is directed to one of the four statutory categories of invention, i.e., process, machine, manufacture, or composition of matter. If the claim does fall within one of the statutory categories, it must then be determined whether the claim is directed to a judicial exception (i.e., law of nature, natural phenomenon, and abstract idea), and if so, it must additionally be determined whether the claim is a patent-eligible application of the exception. If an abstract idea is present in the claim, any element or combination of elements in the claim must be sufficient to ensure that the claim amounts to significantly more than the abstract idea itself. Examples of abstract ideas include fundamental economic practices; certain methods of organizing human activities; an idea itself; and mathematical relationships/formulas. Alice Corporation Pty. Ltd. v. CLS Bank International, et al., 573 U.S. (2014).
In this case, claims 1-20 warrant a rejection in view of Alice under the current guidelines. Applying the 101 flowchart Mayo analysis:
STEP 1: YES, claims 1-20 are directed to one or more of the four statutory categories of invention.
STEP-2A: YES, claims 1-20 are directed to Interfaces and systems for managing healthcare data.
Claims 1-3 are rejected under 35 U.S.C. 101 because the claimed invention, under prong one of step 2A, is directed to generic concepts for implementing data security and managing a healthcare record interface without significantly more. The claim(s) recite(s) a plurality of abstract limitations. For example: claim 1 states that it will “Provide a versatile user interface accessible across a variety of devices, enabling real-time access, creation, management, and sharing of healthcare records by patients, further reinforcing the patients’ rights as primary owners and controllers of their health data [refer to Fig. 7 and Fig. 6]”, claim 2 states: that it will “Employ an advanced, adaptive user interface design optimized for seamless operation across a wide array of devices, including but not limited to computers, smartphones, wearable devices, and embedded systems, thereby enhancing real-time access, management, and sharing of health metrics and records; this interface integrates with wearable devices and other health monitoring equipment for continuous, real-time health status monitoring, promoting proactive patient health management and engagement” and claim 3 states that it uses “Sophisticated data anonymization protocols that utilize state-of-the-art encryption and data processing techniques to ensure the complete removal of personally identifiable information from health data prior to sharing, thereby upholding stringent data privacy standards and fostering user trust”. This judicial exception is not integrated into a practical application because, under prong two, as all of the limitations from the independent claims appear to also contain abstract and ambiguous language in a similar manner as that listed above.
STEP-2B: NO, The claim(s) does/do not include additional elements under step 2B that are sufficient to amount to significantly more than the judicial exception because the additional features claimed are well-understood, routine and conventional generic functions. More specifically, the applicant’s disclosure does not provide definitive explanations for the different claimed elements. Accordingly, these limitations have been determined to be well-understood, routine or conventional by virtue of the applicant's specification. The specification describes the additional elements in a manner that indicates that the additional elements are sufficiently well-known since the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112 (first paragraph) or (a), see particularly figure 4, which essentially shows 3 silhouettes of humans hovering over 3, apparently, independently linked block chains, with the word Consensus. The other figures are similarly ambiguous. Therefore, claim(s) 1-3 is/are directed to non-statutory subject matter. Therefore, these additionally recited elements, when viewed singly and in ordered combination (under a Bascom analysis), do not rise to significantly more than the identified abstract idea. Accordingly, the claims are not eligible subject matter under 101. Likewise, claims 1-3 are rejected, at least based on their respective dependencies on claims 2-20.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
More specifically, claim 1 contains the limitation “Provide a versatile user interface accessible across a variety of devices, enabling real-time access, creation, management, and sharing of healthcare records by patients, further reinforcing the patients’ rights as primary owners and controllers of their health data [refer to Fig. 7 and Fig. 6]”. How, specifically, is a user interface versatile and able to communicate across a variety of devices? What are the different devices? How specifically are a patient’s rights enforced? The drawings don’t provide further definitive explanations. Furthermore, many of the limitations appear to be intended use or intended results of the system (for example: “reinforcing the patients’ rights”). Likewise, the other claims’ limitations are equally as indefinite and thus, also need correcting. For examination purposes, the examiner will attempt to reject the claims based on discernable limitations while not giving patentable weight to claimed intended use or intended results. For example, the above limitation will be treated as if claiming a user interface for accessing a patient’s healthcare records. However, appropriate correction is required. Accordingly, claims 4-6 and 20 are also rejected based on their dependency on claim 1.
Claim 2 contains the limitation “Employ an advanced, adaptive user interface design optimized for seamless operation across a wide array of devices, including but not limited to computers, smartphones, wearable devices, and embedded systems, thereby enhancing real-time access, management, and sharing of health metrics and records; this interface integrates with wearable devices and other health monitoring equipment for continuous, real-time health status monitoring, promoting proactive patient health management and engagement”. How, specifically, is a user interface adaptive? How does it provide seamless operation with a wide array of devices? What are the devices? The drawings don’t provide further definitive explanations. Furthermore, many of the limitations appear to be intended use or intended results of the system (for example: “promoting proactive patient health management and engagement”). Likewise, the other claims’ limitations are equally as indefinite and thus, also need correcting. For examination purposes, the examiner will attempt to reject the claims based on discernable limitations while not giving patentable weight to claimed intended use or intended results. For example, the above limitation will be treated as if claiming a user interface for accessing a patient’s healthcare records that integrates with a wearable device, smartphone, etc.. However, appropriate correction is required. Accordingly, claims 7-14 are also rejected based on their dependency on claim 2.
Claim 3 contains the limitation “Sophisticated data anonymization protocols that utilize state-of-the-art encryption and data processing techniques to ensure the complete removal of personally identifiable information from health data prior to sharing, thereby upholding stringent data privacy standards and fostering user trust”. What specifically are the sophisticated data anonymization protocols? What is the state of the art encryption? The drawings don’t provide further definitive explanations. Furthermore, many of the limitations appear to be intended use or intended results of the system (for example: “upholding stringent data privacy standards and fostering user trust”). Likewise, the other claims’ limitations are equally as indefinite and thus, also need correcting. For examination purposes, the examiner will attempt to reject the claims based on discernable limitations while not giving patentable weight to claimed intended use or intended results. For example, the above limitation will be treated as if claiming a system for removing PID information before sharing data. However, appropriate correction is required. Accordingly, claims 15-19 are also rejected based on their dependency on claim 3.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zelocchi (Pre-Grant Publication No. US 2022/0051276 A1), in view of Warnick et al. (Patent No. US 12,260,440 B1), hereinafter Warnick.
2. With respect to claim 1, Zelocchi taught an Enhanced Comprehensive Digital Healthcare Data Management System with Patient-Centric Data Ownership A digital healthcare data management system, characterized by its patient-centric approach to data ownership (0133, where blockchain teaches the distributed ledger), configured to: Securely store healthcare records utilizing distributed ledger technology, ensuring data integrity and patient privacy through advanced cryptographic hashing and consensus mechanisms, establishing the foundation for patient ownership of healthcare data [refer to FIG. 3 & FIG. 4] (0226); Provide a versatile user interface accessible across a variety of devices, enabling real-time access, creation, management, and sharing of healthcare records by patients, further reinforcing the patients' rights as primary owners and controllers of their health data [refer to FIG. 7 and FIG. 6] (0226); Implement a permissioned access control module that empowers patients with the unequivocal authority to configure their healthcare records, thereby granting or restricting access to different stakeholders, including healthcare providers and family members, based on patient-directed permissions, with functionalities for setting time-bound access, emphasizing the shift in data ownership from organizations to patients themselves (0194); Facilitate the integration and standardization of health records from disparate sources into a cohesive, unified digital health record system through the use of machine learning algorithms for effective translation and format standardization, enhancing data interoperability, accuracy, and ultimately ensuring that the control and ownership of healthcare data are vested in patients, thus fundamentally transforming the traditional dynamics of healthcare data management by centering it around patient autonomy [refer to FIG. 1] (0134).
However, Zelocchi did not explicitly state the ability to configure detailed access rights. On the other hand, Warnick did teach the ability to configure detailed access rights (4:52-67 & 5:22-26). Both of the systems of Zelocchi and Warnick are directed towards managing blockchain records and therefore, it would have been obvious to a person having ordinary skill in the art, at the time of the effective filing of the invention, to modify the teachings of Zelocchi, to specifically use controlling specific permissions, as taught by Warnick, as this function is likely already performed by Warnick in the sharing of data but is not explicitly stated.
3. With respect to claim 2, Zelocchi taught an Advanced Method for Multi-Device Healthcare Data Integration, Access, and Generational Health Management A method for processing and accessing integrated healthcare data within a digital environment (0133), characterized by its comprehensive and patient-centric approach, the method comprising steps to: Aggregate and standardize healthcare records from a myriad of sources into a unified, digital health record system, employing Distributed Ledger Technology to ensure secure, immutable record-keeping and facilitate the patient-centered ownership and control of health data (0134, where blockchain teaches the distributed ledger); Employ an advanced, adaptive user interface design optimized for seamless operation across a wide array of devices, including but not limited to computers, smartphones, wearable devices, and embedded systems, thereby enhancing real-time access, management, and sharing of health metrics and records (0138, where the client access tools house the interface in accordance with figure 1, item 110); this interface integrates with wearable devices and other health monitoring equipment for continuous, real-time health status monitoring, promoting proactive patient health management and engagement (0139); Implement granular, management within the digital health record system, empowering patients with the ability to precisely specify and dynamically adjust access conditions for their healthcare data across different stakeholders-ranging from healthcare providers to family members-thus ensuring robust privacy controls and secure data sharing aligned with patient preferences and consent (0194); Facilitate the creation and maintenance of generational health record chains within the unified digital system, providing patients and their families access to comprehensive health histories that span multiple generations (0226); this feature is instrumental in enabling the early detection of hereditary diseases, facilitating timely and accurate diagnoses, and informing preventive measures to mitigate potential future health issues (0077, the predictions); the system's emphasis on generational health data not only aids in the preservation of familial health legacies but also contributes significantly to personalized medicine and family health management strategies [refer to FIG. 2 & FIG. 5] (0077).
However, Zelocchi did not explicitly state customizable permission settings. On the other hand, Warnick did teach customizable permission settings (4:52-67 & 5:22-26). Both of the systems of Zelocchi and Warnick are directed towards managing blockchain records and therefore, it would have been obvious to a person having ordinary skill in the art, at the time of the effective filing of the invention, to modify the teachings of Zelocchi, to specifically use controlling specific permissions, as taught by Warnick, as this function is likely already performed by Warnick in the sharing of data but is not explicitly stated.
4. With respect to claim 3, Zelocchi taught an Advanced System for Incentivized Health Data Sharing and Research Contribution with Enhanced User Engagement and Data Security, This system, designed to foster the anonymized sharing of health data for research purposes, is characterized by a comprehensive approach that includes privacy protection, collaborative research engagement, and an incentivization mechanism (0137); the system comprises: An integrated incentive mechanism that rewards users with digital tokens or credits for managing their health data, Secure Application Programming Interfaces integrations facilitating the encrypted transmission of anonymized health data to a network of authorized research institutions and partners, ensuring data security during transmission and access, while supporting a seamless exchange of valuable health information for research purposes (0136); A collaborative framework for medical research that not only enables users to contribute to health studies but also integrates a transparent feedback loop, providing users with insights into the research outcomes and findings derived from their shared data, enhancing the visibility of the tangible impacts of their contributions on medical advancements (0136 & 0162); The system further includes a user-centric portal that allows participants to manage their data sharing preferences, view ongoing research projects eligible for data contribution, and track their rewards accumulation, thereby promoting an active and informed user engagement in the research contribution process (0136 & 0162); Additionally, the system implements a modular research participation interface, enabling researchers to specify data requirements for studies, facilitating targeted data collection efforts that align with the specific needs of medical research, thereby optimizing the utility and relevance of shared health data for advancing healthcare knowledge and innovation (0136 & 0162).
However, Zelocchi did not explicitly state that the incentives were for sharing their anonymized data with researchers; where the rewards system is dynamically calibrated based on the quality, volume, and relevance of the shared data to ongoing research studies, encouraging sustained participation and contribution; Sophisticated data anonymization protocols that utilize state-of-the-art encryption and data processing techniques to ensure the complete removal of personally identifiable information from health data prior to sharing, thereby upholding stringent data privacy standards and fostering user trust (4:52-67 & 5:22-26). Both of the systems of Zelocchi and Warnick are directed towards managing blockchain records and therefore, it would have been obvious to a person having ordinary skill in the art, at the time of the effective filing of the invention, to modify the teachings of Zelocchi, to specifically use anonymizing data, as taught by Warnick, in order to better secure a user’s data.
5. As for claim 4, it is rejected on the same basis as claim 1. In addition. Zelocchi taught wherein the secure, patient-owned healthcare data repository utilizes cryptographic hashing and consensus mechanisms for robust data validation and protection, reinforcing the patient's role as the sovereign owner of their health records; the system further supports the creation of a generational health record chain, ensuring that patients can establish and maintain a continuous and secure family health history, enabling long-term health monitoring and the early detection of genetic conditions; additionally, the system's user interfaces are meticulously optimized for both mobile and desktop platforms, featuring adaptive layouts and functionalities tailored to each device type, empowering patients with seamless and flexible access to their health data across devices, while maintaining their position as the ultimate custodians of their health information [refer to FIG. 3, FIG. 4, FIG. 8, and FIG. 9] (0134, where the cryptographic hashing can be seen in 0078).
6. As for claim 5, it is rejected on the same basis as claim 1. In addition. Zelocchi taught wherein the patient-centric data ownership model is augmented by an integrated appointment scheduling module, designed to empower patients with autonomous management of their healthcare engagements, enabling them to directly book, modify, and cancel appointments through a user interface that is synchronized in real-time with both patient and provider calendars; this system feature is complemented by a permissioned access control module, which entrusts patients with the exclusive ability to grant time-bound access to their health records for healthcare providers, thereby facilitating a secure exchange of health information tailored to each medical consultation; such meticulous control reinforces the patient's privacy and bolsters the security of their personal health information, in alignment with the fundamental principle that patients are the unequivocal owners of their healthcare data and have the right to determine how and when it is accessed [refer to FIG. 6 and FIG. 7]. (0137).
7. As for claim 6, it is rejected on the same basis as claim 1. In addition. Zelocchi taught further refined to empower patients with exclusive data ownership, including a feedback mechanism within the user interface that allows patients to directly report inaccuracies, request updates, and assertively manage their healthcare records, thus ensuring the integrity and accuracy of their health information; the system additionally features personalized health analytics tools that generate insights and recommendations, supporting patients in preventive care decision-making processes; these features collectively affirm the patients' status as the principal owners and beneficiaries of their health data, shifting the paradigm from organizational data control to patient-centric data stewardship and autonomy [refer to FIG. 10 and FIG. 11] (0147).
8. As for claim 20, it is rejected on the same basis as claim 1. In addition. Zelocchi taught wherein an integrated solution module is configured to: Centralize healthcare records from multiple healthcare portals and physical paper records into a single, patient-controlled digital repository, thereby simplifying patient access and management of their health records; Enhance data security measures, thereby protecting against breaches and unauthorized access to safeguard patient data; Establish a patient-centric data ownership framework that acknowledges patients as the unequivocal owners of their healthcare data, empowering them to control access to their records exclusively; Provide the capability to store, organize, and maintain family health history, thus enabling the early detection of hereditary conditions and facilitating the proactive management of potential future health risks; Integrate said solution module into the system's user interface to ensure it is readily accessible and user-friendly across the various devices supported by the system, directly addressing the problems depicted in FIG. 1 (0005 & 0141).
9. As for claim 7, it is rejected on the same basis as claim 2. In addition. Zelocchi taught involving the use of machine learning algorithms for the identification, merging, and resolving of duplicates in healthcare records from multiple sources, including the translation and standardization of these records into preferred languages and formats for global interoperability and data sharing, further extending to real-time health metrics monitoring through wearable device integration and dynamic consent management for real-time access permission adjustments [refer to FIG. 2 and FIG. 5] (0179, where merging data teaches resolving duplicates under broadest reasonable interpretation).
10. As for claim 8, it is rejected on the same basis as claim 2. In addition. Zelocchi taught automatic updates of patient health records with new data entries from healthcare providers, labs, and imaging centers, coupled with a predictive health analytics feature that leverages real-time and historical health data for potential health risk identification and notification to patients and healthcare providers (0141, where the predictive health data ca be seen in 0077).
11. As for claim 9, it is rejected on the same basis as claim 2. In addition. Zelocchi taught additionally includes leveraging advanced data analytics to provide users with actionable health insights based on their aggregated and standardized health records, facilitating personalized health management strategies and enabling proactive patient engagement in their healthcare journey (0135, where the patient data includes the aggregated records).
12. As for claim 10, it is rejected on the same basis as claim 2. In addition. Zelocchi taught extends to integrate a seamless communication channel within the user interface, enabling secure and encrypted interactions between patients and healthcare providers, thus enhancing the collaborative care model by streamlining consultations, feedback, and follow-up actions based on real-time health data analysis (0153).
13. As for claim 11, it is rejected on the same basis as claim 2. In addition. Zelocchi taught the process of automatically updating patient health records with new data entries from healthcare providers, labs, and imaging centers, ensuring a continuously updated and comprehensive health record (0141 & 0167).
14. As for claim 12, it is rejected on the same basis as claim 2. In addition. Zelocchi taught extends to incorporate a predictive health analytics feature that analyzes real-time health metrics in conjunction with historical health data to identify potential health risks and notify patients and healthcare providers (0077).
15. As for claim 13, it is rejected on the same basis as claim 2. In addition. Zelocchi taught wherein integrating healthcare data from multiple sources involves utilizing machine learning algorithms to identify, merge, and resolve duplicates across disparate data sets, ensuring data accuracy and completeness (0179, where merging data teaches resolving duplicates under broadest reasonable interpretation).
16. As for claim 14, it is rejected on the same basis as claim 2. In addition. Zelocchi taught wherein the standardization of healthcare records includes aligning the data with international health data standards and formats, facilitating global interoperability and data sharing (0180).
17. As for claim 15, it is rejected on the same basis as claim 3. In addition. Warnick taught where the incentive mechanism includes a rewards system with digital tokens redeemable within a healthcare ecosystem, supported by secure API integrations for encrypted data transmission and data anonymization protocols, ensuring the ethical use of shared anonymized data for medical research, complemented by a participant dashboard for tracking and feedback, fostering transparency and engagement [refer to FIG. 6] (7:45-50, where the reviews allow this under broadest reasonable interpretation, where the tokens were taught by Zelocchi: 0172-0173).
18. As for claim 16, it is rejected on the same basis as claim 3. In addition. Zelocchi taught a comprehensive data privacy and security framework that employs state-of-the-art encryption methods for all data transmissions between the system and third-party research entities, ensuring that participant data sharing is conducted within a secure digital environment, safeguarding against unauthorized access and data breaches (0136).
19. As for claim 17, it is rejected on the same basis as claim 3. In addition. Zelocchi taught a modular research participation interface that allows users to selectively engage with various research studies, providing them with detailed information about the study's goals, the specific data required, and the impact of their contribution, thereby empowering users with the choice and knowledge to make informed decisions about their participation in advancing medical research (0136, where being able to select studies is given by, at least, human choice under broadest reasonable interpretation).
20. As for claim 18, it is rejected on the same basis as claim 3. In addition. Warnick taught ensures that all shared anonymized data is subject to rigorous ethical review and is used solely for the purpose of advancing public health knowledge, with mechanisms in place to audit and verify the use of data by research institutions (7:45-50, where the reviews allow this under broadest reasonable interpretation).
21. As for claim 19, it is rejected on the same basis as claim 3. In addition. Zelocchi taught a feedback loop where participants can receive summaries of research findings and insights derived from their shared data, fostering transparency and participant engagement in medical research (0147 & 0149, the reports).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
(a) Casey et al. (Pre-Grant Publication No. US 2024/0203551 A1), 0018-0019, 0022.
(b) Cordonnier et al. (Patent No. US 11,443,838 B1), column 1.
(c) Abergel et al. (Pre-Grant Publication No. US 2017/0098039 A1), 0014.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH L GREENE whose telephone number is (571)270-3730. The examiner can normally be reached Monday - Thursday, 10:00am - 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas R. Taylor can be reached at 571 272-3889. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH L GREENE/ Primary Examiner, Art Unit 2443