Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Application
Claims 1-21 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendments to the Claims and Remarks filed on 09/29/2025.
Claims 1-5, 7-8, 11-12, and 14-20 are currently amended.
Claim 21 is newly added.
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 1-21 are rejected 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.
Step 1
Claims 1-10 and 21 fall within the statutory category of an apparatus or system. Claims 11-15 fall within the category of an article of manufacture as a computer-readable medium. Claims 16-20 fall within the statutory category of a process.
Step 2A, Prong One
As per Claims 1, 11, and 16, the limitations of determining based on information in the first nomenclature a patient risk for developing a particular disease or condition; determining a change in condition for a first set of patients based at least on monitoring a first set of electronic health records; determining a change in condition associated with at least one of a set of decision epochs based at least one monitoring a second set of electronic health records corresponding to a sect set of patients, wherein the first and second set of patients share in common a set of clinical concepts; receiving caregiver data comprising a second nomenclature and associated with clinical caregiver behavior patterns; performing a first data-conversion operation on the caregiver data comprising the second clinical nomenclature to create a set of transformed caregiver data in the first clinical nomenclature; utilizing the set of transformed caregiver data in the first nomenclature to determine caregiver behavior-pattern information for a first set of caregivers that correspond to the first set of patients; determining that at least a first decision epoch of the set of decision epochs applies to a target patient having the set of clinical concepts, based at least in part on the caregiver behavior-pattern information, the second set of patients, and the set of decision epochs; based on determining that the first decision epoch applies to the target patient, generate a decision support recommendation, describes activities performed by a physician in the treatment of a patient by analyzing patient data including electronic health records to determine a patient risk for developing a condition, change in patient condition, and generating a recommendation for treating the patient through information related to other patient clinical histories, caregiver patterns, and clinical data of the patient themselves. These are activities which are routinely performed by a physician in determining a recommendation for a patient, which amounts to managing personal behavior of the physician and personal interactions between a physician and patient in the course of patient care. If a claim limitation, under its broadest reasonable interpretation, covers the management of personal behavior or personal interactions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The steps of determining a patient risk for developing a disease/condition, determining a change in condition, performing a first data conversion operation on the caregiver data comprising the second clinical nomenclature, to create a set of transformed caregiver data in the first clinical nomenclature, determining caregiver behavior-pattern information utilizing the set of transformed caregiver data in the first clinical nomenclature, determining when a first decision epoch applies to a target patient, and generating a decision support recommendation are claimed in a manner which they can be performed in the human mind using human observation, evaluation, judgment, and option and therefore can also fall into the grouping of mental processes. The data conversion operation is not specified and thus could be performed in any manner and therefore can be a mental process. As per the October 2019 Update on Subject Matter Eligibility, a claim can recite more than one judicial exception. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, the claims recite the additional element – a system including processors and non-transitory media having instructions cause processors to perform the invention. The processors and non-transitory media in these steps is recited at a high-level of generality, such that it amounts to 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 claims also recites the additional elements of invoking one or more agents coupled to a logic data store and operable on data in a first clinical nomenclature at the logic data store to determine patient risk for developing a disease or condition, executing the logic based on information associated with the target patient in the first nomenclature to generate a recommendation, update parameters used by the logic by the algorithm agent, which amounts to mere instructions to apply the exception because the use of a mathematical algorithm applied on a general purpose computer component to perform the abstract idea amounts to mere instructions to apply the exception, as per MPEP 2106.05(f)(2). The claims describe the agent as comprising an algorithm agent coupled to the logic data store which also amounts to mere instructions to apply the exception, as per MPEP 2106.05(f)(2), because the agent is merely recited as a tool to perform the process where the use of a mathematical algorithm applied on a general purpose computer component to perform the abstract idea amounts to mere instructions to apply the exception algorithm agent. The claims also recite the additional element of a clinician graphical user interface to present a version of the decision support recommendation converted to the second clinical nomenclature which uses a general purpose computer component (clinician interface) to merely output data which is the result of the abstract idea. Data outputting amounts to insignificant extra-solution activity, as in MPEP 2106.05(g), because the steps of displaying the recommendation are mere data outputting in conjunction with the abstract idea where the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional element of a computing device to perform the method of the invention amounts to no more than mere instructions to apply the exception using a generic computing component. The system including processors and non-transitory media having instructions cause processors to perform the invention are recited at a high level of generality and are recited as generic computer components by reciting a processor embodied as a single or multiple computing devices (Specification [0038]) and computer-readable media including volatile and nonvolatile media, media implemented in any method or technology for storing information (Specification [0021]), which do not add meaningful limitations to the abstract idea beyond mere instructions to apply an exception. The claims also include use of a clinician graphical user interface which is described as a user interface and application embodied as a software application (specification [0036]) which amounts to general purpose computing components applied as mere instructions to apply the exception. The claims also recite the use of algorithms to execute the abstract idea including agents comprising at least an algorithm coupled to a logic store, execute the logic, and the logic by the algorithm agent coupled to a logic store, which amounts to mere instructions to apply the exception. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims also include the additional elements of presenting the decision support recommendation which is an element that are well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include presenting offers and gathering statistics (OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93), which has been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(iv)). 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 improves the functioning of the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea.
Dependent Claims
Dependent Claims 2-10, 12-15, and 17-20 add further limitations which are also directed to an abstract idea. For example, Claims 2, 12, and 17 include generating a patient assessment for a clinical decision support event for the target patient, wherein the patient assessment includes at least one question-answer pair corresponding to one or more coded clinical concepts in a coded clinical format which is directed to certain methods of organizing human activity for the same reasons as the independent claims. The claims also include utilizing machine learning executed by the processors which is the use of a mathematical algorithm to execute the abstract idea which is mere instructions to apply the exception.
Claims 3, 13, and 18 include determining a question from mapped content of patient health records indicating concepts that frequently occur in association with a particular condition which is directed to certain methods of organizing human activity for the same reasons as the independent claims. The claims also include the use of machine learning to execute the abstract idea which is the use of a mathematical algorithm to execute the abstract idea which is mere instructions to apply the exception and also the use of network-based storage devices for storing patient health records, which is the use of a computer in its ordinary capacity for tasks such as storing data, which also amounts to mere instructions to apply the exception, as in MPEP 2106.05(f)(2).
Claims 4, 14, and 20 include directing a message to the clinician based on an association of a role of a caregiver to a clinical concept, of the set of clinical concepts, associated with at least one answer to the at least one question-answer pair which is management of personal interactions and thus falls into the abstract grouping of certain methods of organizing human activity.
Claims 5, 15, and 19 include determining a clinical concept code associated with a first question and a first answer received in the second clinical nomenclature in response to the first question, which is directed to certain methods of organizing human activity for the same reasons as the independent claims. The claims also include storing the clinical concept code in the first clinical nomenclature in a set of clinical information for the set of clinical concepts, which is the use of a computer in its ordinary capacity for tasks such as storing data, which also amounts to mere instructions to apply the exception, as in MPEP 2106.05(f)(2).
Claims 6 and 15 include limitations which further specify or limit the elements of the independent claims, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1 and 11.
Claims 7 and 8 include displaying a clinical graphical user interface which is insignificant extra-solution activity as mere data outputting, which is well-understood, routine, and conventional computer activity for the same reasons as the independent claims.
Claim 9 includes determining that at least the first decision epoch applies to the target patient, which is directed to certain methods of organizing human activity for the same reasons as the independent claims.
Claim 10 includes determining a definition of the set of decision epochs based at least on the one or more parameters, which is directed to certain methods of organizing human activity for the same reasons as the independent claims.
Claim 21 includes performing a second data-conversion operation on the decision support recommendation to generate the version of the decision support recommendation in the second clinical nomenclature, which is directed to an abstract idea. The action of performing a data conversion operation is recited such that it can be performed in the normal activity of analyzing medical records of a patient by a care provider to create files and reports for the medical records which is certain methods of organizing human activity. This step can also be performed using human mental evaluation, observation, judgment, and opinion since the data conversion operation is not specified and can be as simple as a mapping using a chart or guide of matching clinical nomenclatures. Therefore, this can also be directed to a mental process.
Because the additional elements do not impose meaningful limitations on the judicial exception and the additional elements are well-understood, routine and conventional functionalities in the art, the claims are directed to an abstract idea and are not patent eligible.
Subject Matter Free of the Prior Art
The following is an examiner’s statement of subject matter free of the prior art: The limitations in Claims 1, 11, and 16 stating: determining when at least a first decision epoch of the set of decision epochs applies to a target patient having the set of clinical concepts, based at least in part on the caregiver behavior-pattern information, the second set of patients, and the set of decision epochs, is free of the prior art. The broadest reasonable interpretation of the claim language requires the use of all three of caregiver behavior-pattern information, second set of patients, and set of decision epochs to be used in determining when a first decision epoch applies to a target patient.
Response to Arguments
Applicant’s arguments, see Pages 10-13, “Rejections under 35 U.S.C. §101”, filed 09/29/2025 with respect to claims 1-21 have been fully considered but they are not persuasive.
Applicant argues that the claims of the present application are self-evidently compliant with §101 because the independent claims invoke artificial-intelligence agents, coupled to a logic data store, and operable on data such that the claim as a whole is not performed with a human or among humans, does not recite a human, and integrates the purported excluded category into a practical application. Examiner respectfully disagrees. The independent claims recite computer components which are applied to the abstract idea itself to carry out the method of the invention. However, these components are general purpose computer components such as agents coupled to a logic data store, which are shown in the rejection above to be described in the specification as general purpose computing components. The use of programs or instructions and a data storage to carry out the method of the claims are additional elements which amount to mere instructions to apply the exception. The claim is not required to recite a human for the activity to be that which is carried out by a person or as managing interactions between people or personal behaviors. Applicant additionally argues that the claims as a whole does not tie up any excluded category such that others cannot practice it and does not need to proceed through the full analysis as its eligibility is self-evident. In response to the argument that the streamlined eligibility analysis may be used, Examiner respectfully disagrees with this analysis. The streamlined analysis is intended to be used only for claims which clearly do not seek to tie up any judicial exception wherein the eligibility of the claims is self-evident. If there is any doubt as to whether the claim seeks coverage for a judicial exception itself, a full analysis should be performed. The Ultramercial decision makes it clear that arguments regarding pre-emption are not a substitute for the proper two-part test under Alice. In this case, the claims are still directed to an abstract idea and do not recite significantly more than the abstract idea.
Applicant argues that the claims do not recite an abstract idea and specifically the claims are not directed to certain methods of organizing human activity because the activity is not performed among humans or at least performed between a human and a computer. Applicant argues that the present claims include operations which are performed by organizing hardware microprocessors and not performed by humans. As described above, the use of a computer to carry out the steps of the abstract idea amounts to mere instructions to apply the exception. The present claims are directed to generating decision support recommendations for a patient which is a fundamental activity performed by a care provider in the care of a patient. Similarly to MPEP 2106.04(a)(2)(II)(C) in which a claim recites the use of a computer to carry out the steps of self-verification of a ballot, which was found by the courts to be fundamental activity that forms the basis of our democracy and has been performed by humans for year, the current claims are fundamental activity of treating or caring for a patient and are therefore directed to certain methods of organizing human activity. The use of the computer components to carry out the abstract idea amounts to mere instructions to apply the exception.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682
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