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 .
Claim Objections
Claim 13 is objected to because of the following informalities: Claim 13 appears to be identical to Claim 1 but with the entire process recited twice (likely a drafting error). This redundancy adds nothing to patent eligibility. Appropriate correction is required.
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 1-24 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. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Independent Claim(s) 1 and 13 directed to the abstract idea of relationship counseling through mental modeling and intervention planning specifically, the mental processes of collecting and analyzing relationship data, creating a mental model (digital copy) of a couple, generating interventions based on that model, testing interventions in the model, presenting results, and tracking outcomes.
Independent Claim 1 recites “collecting data related to a subject couple; analyzing the collected data related to the subject couple; creating a digital copy of the subject couple based on the analyzed collected data; generating personalized interventions and/or predictive outcomes based on the analyzed collected data related to the subject couple; implementing the generated personalized interventions and/or predictive outcomes in the digital copy of the subject couple; presenting personalized interventions and/or predictive outcomes to the subject couple based on results from implementing the generated personalized interventions and/or predictive outcomes in the digital copy of the subject couple; and tracking results data of the presented personalized interventions and/or predictive outcomes implemented by the subject couple.”
Independent Claim 13 recites “collecting data related to a subject couple; analyzing the collected data related to the subject couple; creating a digital copy of the subject couple based on the analyzed collected data; generating personalized interventions and/or predictive outcomes based on the analyzed collected data related to the subject couple; implementing the generated personalized interventions and/or predictive outcomes in the digital copy of the subject couple; presenting personalized interventions and/or predictive outcomes to the subject couple based on results from implementing the generated personalized interventions and/or predictive outcomes in the digital copy of the subject couple; and tracking results data of the presented personalized interventions and/or predictive outcomes implemented by the subject couple.”
The limitations of Claims 1 and 13, as drafted, under its broadest reasonable interpretation, covers the performance of a “Mental Process” which are concepts performed in the human mind (including an observation, evaluation, judgment, opinion) and/or Certain Methods Of Organizing Human Activity which are concepts performed by managing personal behavior, relationships or interactions between people (including fundamental economic principles, commercial or legal interactions, social activities, teaching, and following rules or instructions), but for the recitation of generic computer components. That is, other than reciting, “couple-based digital reproductive health system, server, including a reproductive health application, ML algorithms, multimodal Al, reproductive health GUI, controller, operating memory, and a communications interface, wherein the server is accessible via a network; data store” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “health system” language, “collecting” in the context of this claim encompasses the user manually retrieving subject couple data. Similarly, the “analyzing” the collected data related to the subject couple, under its broadest reasonable interpretation, covers performance of the limitation in the mind, but for the recitation of generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of using a “couple-based digital reproductive health system, server, including a reproductive health application, ML algorithms, multimodal Al, reproductive health GUI, controller, operating memory, and a communications interface, wherein the server is accessible via a network; data store” to perform all of the “obtaining, transforming, parsing, determining, transforming, selecting and storing” steps. The “couple-based digital reproductive health system, server, including a reproductive health application, ML algorithms, multimodal Al, reproductive health GUI, controller, operating memory, and a communications interface, wherein the server is accessible via a network; data store” is/are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function) of executing computer-executable instructions for implementing the specified logical function(s) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claim 1 has the following additional elements (i.e., server, including a reproductive health application, ML algorithms, multimodal Al, reproductive health GUI, controller, operating memory, and a communications interface, wherein the server is accessible via a network; data store). Claim 13 has the following additional elements (i.e., couple-based digital reproductive health system, server, including a reproductive health application, ML algorithms, multimodal Al, reproductive health GUI, controller, operating memory, and a communications interface, wherein the server is accessible via a network; data store). Looking to the specification, these components are described at a high level of generality (page 26 || 17-22; The couples 180 may access couple-based digital health application 310 at application server 350 via their respective user computers 360 and network 344. User computers 360 may be any computing device, such as, but not limited to, a desktop computer, a laptop computer, a handheld computing device, a mobile phone (or smart phone), a tablet device, a smartwatch, and the like.). The use of a general-purpose computer, taken alone, does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, although the claims add “[storage]” steps, it is only considered as insignificant extrasolution activity. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
It is worth noting that the above analysis already encompasses each of the current dependent claims (i.e., claims 2-12 and 14-24). Particularly, each of the dependent claims also fails to amount to “significantly more’ than the abstract idea since each dependent claim is directed to a further abstract idea, and/or a further conventional computer element/function utilized to facilitate the abstract idea. Accordingly, none of the current claims implements an element—or a combination of elements—directed to an inventive concept (e.g., none of the current claims is reciting an element—or a combination of elements—that provides a technological improvement over the existing/conventional technology). These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Mental Processes,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Claims 1-24 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
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.
Claims 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Pub. No.:
As per Claim 1, Yao teaches a couple-based digital reproductive health system, comprising:
a server, the server including a reproductive health application, ML algorithms, multimodal Al, reproductive health GUI, controller, operating memory, and a communications interface, wherein the server is accessible via a network (see Yao paragraphs 37 and 107);
a data store in communication with the server (see Yao paragraphs 37; a database server that receives data that is entered on the data input form for archiving, transmission to computation server, and the retrieval of data during troubleshooting); and
wherein the controller is configured to execute stored program instructions, comprising:
collecting data related to a subject couple (see Yao paragraph 16; In a further embodiment of the invention, the DSS may be a stand-alone DSS or it may be integrated with an electronic health record (EHR). The EHR may comprise an internet platform that supports entry of personal health data of an individual, wherein the personal health data may be entered into the EHR platform by the individual, a physician, a healthcare provider, or a clinic administrator, each of which may individually designate sharing privileges for the EHR, wherein the sharing privileges may be tailored to specify time limits for sharing. In addition, the EHR platform may comprise support of clinic-oriented services and direct to consumer goods and services.);
analyzing the collected data related to the subject couple (see Yao paragraph 87; The EHR system of the present invention allows individuals a great deal of flexibility in completing the EHR questionnaires. For example, individuals have the option of answering the questionnaire wherever desired, or to upload past clinical records (e.g., photocopies of physician notes, printouts of lab results, operative reports, etc.) as a portable document format (pdf) or a comparable format. The uploaded materials will be integrated into the EHR system in a searchable format in order to facilitate the extraction of meaningful data from the documents for outcomes analysis and predictions);
creating a digital copy of the subject couple based on the analyzed collected data (see Yao paragraph 87; The EHR system of the present invention allows individuals a great deal of flexibility in completing the EHR questionnaires. For example, individuals have the option of answering the questionnaire wherever desired, or to upload past clinical records (e.g., photocopies of physician notes, printouts of lab results, operative reports, etc.) as a portable document format (pdf) or a comparable format. The uploaded materials will be integrated into the EHR system in a searchable format in order to facilitate the extraction of meaningful data from the documents for outcomes analysis and predictions);
generating personalized interventions and/or predictive outcomes based on the analyzed collected data related to the subject couple (see Yao paragraph 87; The EHR system of the present invention allows individuals a great deal of flexibility in completing the EHR questionnaires. For example, individuals have the option of answering the questionnaire wherever desired, or to upload past clinical records (e.g., photocopies of physician notes, printouts of lab results, operative reports, etc.) as a portable document format (pdf) or a comparable format. The uploaded materials will be integrated into the EHR system in a searchable format in order to facilitate the extraction of meaningful data from the documents for outcomes analysis and predictions);
implementing the generated personalized interventions and/or predictive outcomes in the digital copy of the subject couple (see Yao paragraph 36; In a further embodiment of the invention, test output (typically in the form of a written or on-line report) shows the predicted probability of a certain outcome, and/or distribution of predicted probabilities vs. actual outcomes for the test population. For example, a test may be shown on a screen, such as a computer monitor, and the test may be saved as an image, emailed, or printed. Test output may be short (e.g., one page) or long (e.g., multiple pages to provide test result along with fully annotated educational materials);
presenting personalized interventions and/or predictive outcomes to the subject couple based on results from implementing the generated personalized interventions and/or predictive outcomes in the digital copy of the subject couple (see Yao paragraph 36; In a further embodiment of the invention, test output (typically in the form of a written or on-line report) shows the predicted probability of a certain outcome, and/or distribution of predicted probabilities vs. actual outcomes for the test population. For example, a test may be shown on a screen, such as a computer monitor, and the test may be saved as an image, emailed, or printed. Test output may be short (e.g., one page) or long (e.g., multiple pages to provide test result along with fully annotated educational materials); and
tracking results data of the presented personalized interventions and/or predictive outcomes implemented by the subject couple (see Yao paragraphs 31, 36 and 122; The EHR-driven DSS can track the patient's menstrual symptoms and/or any other health symptoms.).
While Yao teaches a server, health application, ML algorithms, controller and a communications interface, Yao fails to explicitly teach multimodal Al, reproductive health GUI, operating memory and said server accessible via a network.
Luellen teaches the network provides a communication infrastructure between the server(s) and User Devices. The network is typically the Internet; however, could be any Transmission Method or network.
Any User may create a patient-centric electronic file(s) or data Storage by inputting said data types into the system or Application or Modules, which shall include but not be limited to fields storing or presenting the following information types: Patient, Medication, Behavioral, Biometric, Epidemiological, Environmental, Medical, Pharmacovigilance, Social, Social Media, or Virtual Data.
In another embodiment, the invention, systems, methods, Applications, or Modules described herein could be used by technology or other companies to serve as part of or to supplement, or feed a larger computer system, artificial intelligence, deep learning, or semantic meaning analysis systems (e.g., including but not limited to IBM's Watson, Wolfram Alpha, DeepDive, Google's DeepMind, Microsoft's Cortana, MyA, MindMeld, HP Autonomy, Palantir, etc., or their successors) to facilitate improved pharmacotherapy management or efficacy, improved patient safety or treatment efficacy or options, or knowledge management, discovery, research or learning (see Luellen Abstract and paragraphs 20, 42, 95 and 143).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include systems/methods as taught by reference Luellen within the systems/methods as taught by reference Yao with the motivation of providing a platform for managing medication therapy regimens, maximizing patient safety and coordinating care, thereby improving clinical outcomes, regulatory reporting, and research Analysis (see Luellen paragraph 53).
As per Claim 2, Yao and Luellen teach the system of claim 1, wherein the data related to the subject couple is collected via data modalities, and wherein the data modalities comprise exposome data and biological data (see Luellen paragraphs 23, 85 and 143; Any User may create a patient-centric electronic file(s) or data Storage by inputting said data types into the system or Application or Modules, which shall include but not be limited to fields storing or presenting the following information types: Patient, Medication, Behavioral, Biometric, Epidemiological, Environmental, Medical, Pharmacovigilance, Social, Social Media, or Virtual Data. In other embodiments, data types described herein may be put into the system via any Transmission method from any Source in various embodiments).
The obviousness of combining the teachings of Yao and Luellen are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 3, Yao and Luellen teach the system of claim 2, wherein the biological data comprises omics data (see Luellen paragraph 131; “Medical Data” as used herein is defined to include, but not be limited to, medication information related to a patient, or cohorts of patients, expressly including blood chemistry, data related to heart or brain or respiratory tract or circulatory or optical or renal or immune or gastrointestinal or endocrinological or dermatological or ocular or reproductive or nervous system, data related to health or family history, psychiatric and/or psychological health, substance abuse, developmental history, psychosocial or sociocultural history, occupational and/or military history, problems, reactions, Medications, progress notes, diagnostic results, images, scans, blood chemistry, electrolytes, hydration status, toxin or Medication exposure, microbiome, cellular sequencing or activity, genetic, proteinomics (including dynamics and folding), DNA, RNA….).
The obviousness of combining the teachings of Yao and Luellen are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 4, Yao and Luellen teach the system of claim 1, wherein the presented personalized interventions and/or predictive outcomes comprise the generated personalized interventions and/or predictive outcomes that resulted in a positive outcome when implemented in the digital copy of the subject couple (see Yao paragraph 17; In another embodiment of the invention, the DSS provides personalized predictions based upon the information entered into the EHR for a specific condition or disease state. Where the EHR is specific for fertility treatments, the DSS provides personalized predictions of at least one fertility outcome for the individual. In one embodiment of the invention, the fertility outcome is the probability of a live birth event).
The obviousness of combining the teachings of Yao and Luellen are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 5, Yao and Luellen teach the system of claim 1, wherein the multimodal AI and/or ML algorithms process the collected data related to the subject couple, create the digital copy of the subject couple, generate the personalized interventions and/or predictive outcomes, implement the generated personalized interventions and/or predictive outcomes in the digital copy of the subject couple, and/or track the results data of the presented personalized interventions and/or predictive outcomes implemented by the subject (see Yao paragraph 17; In another embodiment of the invention, the DSS provides personalized predictions based upon the information entered into the EHR for a specific condition or disease state. Where the EHR is specific for fertility treatments, the DSS provides personalized predictions of at least one fertility outcome for the individual. In one embodiment of the invention, the fertility outcome is the probability of a live birth event).
The obviousness of combining the teachings of Yao and Luellen are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 6, Yao and Luellen teach the system of claim 1, wherein the subject couple comprises one of a man and a woman, a woman and a sperm donor, or a man and an egg donor (see Yao paragraphs 88 and 120).
The obviousness of combining the teachings of Yao and Luellen are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 7, Yao and Luellen teach the system of claim 1, further comprising a reproductive family health archive, wherein the reproductive family health archive comprises an archive of data collected from each subject couple using the couple-based digital health platform system (see Yao paragraphs 88 and 120).
The obviousness of combining the teachings of Yao and Luellen are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 8, Yao and Luellen teach the system of claim 7, wherein the reproductive family health archive further comprises data collected from one or more offspring of the subject couple (see Yao paragraphs 73, 88 and 120).
The obviousness of combining the teachings of Yao and Luellen are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 9, Yao and Luellen teach the system of claim 1, further comprising one or more entities in communication with the server via the network, wherein the one or more entities comprise healthcare providers, one or more laboratory service providers, one or more pharmacies, and/or one or more IVF providers (see Yao paragraph 16; In a further embodiment of the invention, the DSS may be a stand-alone DSS or it may be integrated with an electronic health record (EHR). The EHR may comprise an internet platform that supports entry of personal health data of an individual, wherein the personal health data may be entered into the EHR platform by the individual, a physician, a healthcare provider, or a clinic administrator, each of which may individually designate sharing privileges for the EHR, wherein the sharing privileges may be tailored to specify time limits for sharing. In addition, the EHR platform may comprise support of clinic-oriented services and direct to consumer goods and services.).
The obviousness of combining the teachings of Yao and Luellen are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 10, Yao and Luellen teach the system of claim 1, wherein the instructions further comprise generating alternative personalized interventions and/or predictive outcomes for the subject couple (see Yao paragraph 17; In another embodiment of the invention, the DSS provides personalized predictions based upon the information entered into the EHR for a specific condition or disease state. Where the EHR is specific for fertility treatments, the DSS provides personalized predictions of at least one fertility outcome for the individual. In one embodiment of the invention, the fertility outcome is the probability of a live birth event).
The obviousness of combining the teachings of Yao and Luellen are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 11, Yao and Luellen teach the system of claim 10, wherein the multimodal AI and/or ML algorithms generate the alternative personalized interventions and/or predictive outcomes (see Yao paragraph 17; In another embodiment of the invention, the DSS provides personalized predictions based upon the information entered into the EHR for a specific condition or disease state. Where the EHR is specific for fertility treatments, the DSS provides personalized predictions of at least one fertility outcome for the individual. In one embodiment of the invention, the fertility outcome is the probability of a live birth event).
The obviousness of combining the teachings of Yao and Luellen are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 12, Yao and Luellen teach the system of claim 1, wherein the data store stores one or more of data modalities, subject couple health data, other entities data, personalized predictions data, personalized interventions data, and/or reproductive family health archive data (see Yao paragraphs 16-17; In a further embodiment of the invention, the DSS may be a stand-alone DSS or it may be integrated with an electronic health record (EHR). The EHR may comprise an internet platform that supports entry of personal health data of an individual, wherein the personal health data may be entered into the EHR platform by the individual, a physician, a healthcare provider, or a clinic administrator, each of which may individually designate sharing privileges for the EHR, wherein the sharing privileges may be tailored to specify time limits for sharing. In addition, the EHR platform may comprise support of clinic oriented services and direct to consumer goods and services.).
The obviousness of combining the teachings of Yao and Luellen are discussed in the rejection of claim 1, and incorporated herein.
As per Claims 13-24, Claims 13-24 are directed to a method of using a couple-based digital reproductive health platform. Claims 13-24 recite the same or substantially similar limitations as those addressed above for Claims 1-12 as taught by Yao and Luellen. Claims 13-24 are therefore rejected for the same reasons as set forth above for Claims 1-12 respectively.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pub. No.: US 20250061995 A1: The couple-based digital reproductive health platform system has a server including a reproductive health application, machine learning algorithms, multimodal artificial intelligence (120), reproductive health graphical user interface, operating memory, and a communications interface, where the server is accessible through a network. A data store is provided in communication with the server. A controller is provided to execute stored program instructions for collecting data related to a subject couple (180), analyzing the collected data related to the subject couple, creating a digital copy of the subject couple based on the analyzed collected data, generating personalized interventions (124) or predictive outcomes based on the analyzed collected data related to the subject couple, and tracking results data of the presented personalized interventions or predictive outcomes implemented by the subject couple.
WO 2020247498 A1: The computer-based method involves collecting patient and caregiver dyadic data by multiple computer devices associated with a health system (130), such that the patient and caregiver dyadic data is received from a patient and a caregiver user computing device (110, 120). The cancer or non-cancer pain events data or cancer-related or other disease-related symptom events data of the patient (101) is received. The patient and caregiver dyadic data is related to the cancer or non-cancer pain events data or cancer-related or other disease-related symptom events data of patient. The real- time personalized intervention information is generated for the patient and caregiver (103) based on the relation, and the real-time personalized intervention information is communicated to the patient user computing device and caregiver user computing device for appropriate action to be undertaken, to anyone or more of the following: the caregiver, the patient, or both the caregiver and patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD B WINSTON III whose telephone number is (571)270-7780. The examiner can normally be reached M-F 1030 to 1830.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.B.W/ Examiner, Art Unit 3683
/ROBERT W MORGAN/ Supervisory Patent Examiner, Art Unit 3683