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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/31/2026 has been entered.
Status of the Application
Claims 1-6 and 9-23 are currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Amendments to the Claims and Remarks filed on 03/31/2026.
Claims 1-6, 9-11, and 16-21 are currently amended.
Claims 22-23 are newly added.
Claims 7-8 are canceled and not considered at this time.
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 1-6 and 9-23 are rejected because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-6, 9-10 and 21-23 fall within the statutory category of a process. 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 an apparatus or system.
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, based on the first clinical nomenclature, a change in condition for a first set of patients in response to monitoring a first set of electronic health records and a change in condition associated with at least one of a set of decision epochs in response to 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, based on a second nomenclature, a set of caregiver data in the second nomenclature and associated with clinical caregiver behavior patterns; transforming, based on a first data-conversion operation, the caregiver data in the second clinical nomenclature, wherein transforming the set of caregiver data in the second clinical nomenclature comprises: mapping via the set of caregiver data in the second clinical nomenclature to 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 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 and information associated with the target patient in the first clinical nomenclature, determine the patient risk for developing the particular disease or condition, generate a decision support recommendation based on the patient risk, 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, transforming the set of caregiver data in the second clinical nomenclature including mapping the set of caregiver data in the second clinical nomenclature to 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, determining the patient risk for developing the particular disease or condition, 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, based on a first clinical nomenclature, one or more agents coupled to a logic data store and operable on data in the first clinical nomenclature at the logic data store to determine patient risk for developing a disease or condition, executing the logic associated with the first clinical nomenclature, 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 updating 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 generating a patient assessment that includes 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 a question-answer pair that corresponds to a coded clinical concepts in the second clinical nomenclature 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. The claims also include executing a decision support application that displays a graphical user interface, which amounts to mere instructions to apply the exception because use of an application amounts to use of software by a general purpose computer to execute the steps of the abstract idea, as per MPEP 2106.05(f)(2).
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.
Claim 22 includes determining a question of a question-answer pair from a mapped content of the first and second sets of electronic health records and generating a patient assessment for a clinical decision support event based on the question; receiving a response to the patient assessment; converting the response to the second clinical nomenclature via a second data-conversion operation; and updating the mapped content based on learning information acquired from a non-standardized response which are directed to certain methods of organizing human activity for similar reasons to the independent claims. Additionally, determining a question from mapped content, generating a patient assessment, converting the response, and updating the mapped content can be performed using human mental evaluation, observation, judgment, and opinion and therefore fall into the abstract grouping of mental processes. The use of a machine learning model to carry out steps of the abstract idea amount to mere instructions to apply the exception.
Claim 23 includes receiving caregiver information in the first nomenclature and associated with behavior patterns of clinical caregivers, and utilizing the caregiver information in the first clinical nomenclature to determine caregiver behavior-pattern information for a group of caregivers that correspond to the first set of patterns, which are directed to certain methods of organizing human activity for similar reasons to the independent claims. Additionally, the determining caregiver behavior-pattern information step can be performed using human mental evaluation, observation, judgment, and opinion and therefore fall into the abstract grouping of mental processes. The use of one or more agents to carry out steps of the abstract idea amount to mere instructions to apply the exception.
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 12-17, "Rejections under 35 U.S.C. §101", filed 03/31/2026 with respect to claims 1-21 have been fully considered but they are not persuasive.
Applicant argues that the claims of the present application do not recite an abstract idea because the claims do not recite any form of certain methods of organizing human activity because the elements of the claims are not performed with a single human, or among humans and does not recite a human or humans. Examiner respectfully disagrees. The claims do not require recitation of a human for the functions of the claims to be that which could be performed by humans or is activity which manages inter or intra personal activities. The elements of the claims describe the activity performed in generating a decision support recommendation which is activity performed by a physician in the treatment of a patient. The management of treatment of a patient is activity performed between a physician and a patient which falls into the abstract grouping of certain methods of organizing human activity.
Applicant argues that there are other publications or prior office actions cited by the Examiner in which the claims were not analyzed as certain methods of organizing human activity abstract ideas. Examiner notes that each claim set is analyzed individually and the exact reasoning and analysis for each set of claims cannot be used to analyze a different set of claims or invention.
Applicant argues that the claims are not directed to an abstract idea because they do not recite a mental process. Applicant argues that the claim does not include elements which can be performed in the human mind. Examiner respectfully disagrees. The claim elements including 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 all steps which can be performed using human mental observation, evaluation, judgment, and opinion. A person can mentally make determinations about a patient risk for developing disease, a change in condition of the patient, caregiver behavior-pattern information, when a first decision epoch applies to a patient, and a decision support recommendation. These are activities which physicians perform daily in the care of patients. The data conversion operation is claimed at a high-level of generality such that mapping a first set of data to a second set of data using comparison or tables would be sufficient to convert the data from one nomenclature to the another, and this can be performed mentally or with the aid of pen and paper. Therefore, these steps are directed to a mental process.
Applicant argues that the present claims provide additional elements which integrate the abstract idea into a practical application because there claims contain subject matter which is free of the prior art. Examiner notes that this is a separate and distinct consideration from subject matter eligibility. Whether a claim is free of the prior art is a question of novelty rather than eligibility. An abstract idea need not be old or long-prevalent to be abstract. Even a newly discovered abstract idea is still directed to a judicial exception regardless of its novelty.
Applicant argues that the present claims integrate the abstract idea into a practical application because they provide an improvement in technology by enabling a particular device (corresponding to a conventional computer) to perform more efficiently. Applicant provides as an example that invoking AI agents operable on data in a first nomenclature to determine a patient risk for developing disease and mapping a set of caregiver data in a second nomenclature to create a set of transformed caregiver data in the first nomenclature. Examiner is not persuaded that this provides an improvement to a computer or improves the efficiency of the operating of the computer itself. These are steps which are performed by a conventional computer and any improvement of the determining a patient risk and converting data is an improvement to the abstract idea itself. The efficiencies found by applying this to a computer are attributable to the computer itself and therefore amount to mere instructions to apply the exception, as per MPEP 2106.05(f).
Applicant provides a list of examples which are, presumably, to support that conversion of data items among a first and second nomenclatures provides an improvement to technology. The claims of the provided applications are not identical to the present case and each case is analyzed individually under the 2-Step 101 Analysis. Applicant also references the 12/4 and 12/5 memos regarding expansive eligibility. However, there is no mention of “expansive eligibility” in any portions of memos from 12/4 or 12/5. These are directed to reminders of the USPTO’s guidance on affidavits and declarations as well as subject matter eligibility guidance. Examiner does not find these relevant or analogous to the present application or present claims, as the present claims do not provide a technical solution similar to overcoming the problem of “catastrophic forgetting” which is discussed in Ex Parte Desjardins.
Applicant argues that the present claims provide an inventive concept which amounts to significantly more than the abstract idea. However, Applicant does not provide any particular or specific arguments as to what additional elements provide significantly more than the abstract idea and how these elements are not well-understood, routine, and conventional. The office action above describes the additional elements that are considered to be insignificant extra-solution activity and provides reasoning from the Specification or MPEP for each additional element as to how these are well-understood, routine, and conventional. Mere instructions to apply the exception cannot provide significantly more than the abstract idea and therefore do not require evidence as to being well-understood, routine, and conventional.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682
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