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 1-7, 10-17, and 71-73 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendment to the Claims and Remarks filed on 07/20/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-7, 10-17, and 71-73 are rejected because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-7 and 10-15 fall within the statutory category of a process. Claims 17 and 71-73 fall within the statutory category of an apparatus or system. Claim 16 is falls within the statutory category of an article of manufacture as a computer-readable medium.
Step 2A, Prong One
As per Claims 1, 16, and 17, the limitations of determining a patient selection criteria to set a balance between precision and recall for action responsive to an output of the toxicity-related model including a toxicity prediction; processing healthcare data from a healthcare record for a given patient to generate the toxicity prediction; evaluating the toxicity prediction with respect to the patient and the patient selection criterion; when the toxicity prediction satisfies the patient selection criterion, generating a first indication and configuring the treatment plan to include the immunotherapy, wherein configuring the treatment plan to include the immunotherapy includes determining a schedule for application of the immunotherapy to the patient and provisioning patient monitoring to evaluate the patient during execution of the treatment plan; when the toxicity prediction, does not satisfy the patient selection criterion, generating a second indication and excluding the immunotherapy from the treatment plan; and outputting an order configuring the treatment plan for the patient based on the first or second indication, under its broadest reasonable interpretation, covers managing interactions between people and personal behavior. The steps of determining a patient selection criterion, processing healthcare data to generate the toxicity prediction, evaluating the toxicity prediction, generating a first or second indication based on whether the toxicity prediction satisfies the criterion, configuring the treatment plan to include immunotherapy by determining a schedule for application and provision patient monitoring to evaluate the patient during the treatment plan, or excluding the immunotherapy, and outputting an order configuring the treatment plan for the patient are concepts which are performed by a physician in the treatment of a patient. Physicians routinely configure treatment plans for patients by analyzing the data including determining patient selection criterion, processing healthcare data, generating and evaluating toxicity prediction, and generating an indication. The physician then outputs a treatment plan based on the indication. This describes managing personal interactions between a patient and physician. If a claim limitation, under its broadest reasonable interpretation, covers the management of personal behavior and personal interactions, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. 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 elements – a computer-readable medium, memory, instructions, and processor circuitry. The computer-readable medium, memory, instructions, and processor circuitry in these steps are 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 recite the additional elements of loading a toxicity-related model for a selected toxicity associated with an immunotherapy, the toxicity related model selected from a plurality of candidate models using a model selection criterion, which amounts to mere instructions to apply the exception. The specification describes loading the model as the models being stored and/or utilized in external systems ([0082]). This amounts to the use of computers in its ordinary capacity for tasks such as storing data, as per MPEP 2106.05(f)(2). 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 computer-readable medium, memory, instructions, and processor circuitry to perform the method of the invention amounts to no more than mere instructions to apply the exception using a generic computing component. The computer-readable medium, memory, instructions, and processor circuitry are recited at a high level of generality and are recited as generic computer components by reciting machine readable media such as optical storage devices, etc. (Specification [00256]), storage devices such as floppy disk drives, CDs, etc. (Specification [00264]), and processing circuitry which is described as means for processing (Specification [00365]), which do not add meaningful limitations to the abstract idea beyond mere instructions to apply an exception. The claims also include loading a toxicity-related model for a selected toxicity associated with an immunotherapy, the toxicity related model selected from a plurality of candidate models using a model selection criterion, which is storing data that amounts to mere instructions to apply the exception. This is also shown to be well-understood, routine, and conventional in the art, per MPEP 2106.05(d)(II) which describes storing and retrieving information in memory as computer functions found to be well-understood, routine, and conventional. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. 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 2-7, 10-15 and 71-73 add further limitations which are also directed to an abstract idea. For example, Claims 2 and 71 include generating a toxicity-related model by forming features from an input data set obtained from healthcare records, the features iteratively compared through associated outcomes to form the model, the model tuned according to an analysis of precision and recall. Generating the model is recited at a high level of generality such that it could be performed using human mental evaluation and analysis which includes forming features, comparing outcomes, and tuning the model which are also recited at a high-level of generality. Claims 3 and 72 include loading an efficacy model which is storing data similar to the independent claims. The claims also include determining patient selection criteria, processing healthcare data from a healthcare record to generate efficacy prediction, and evaluating the prediction which amount to certain methods of organizing human activity for the same reasons as the independent claims. Claims 4 and 73 include generating a first and second indication and configure a treatment plan based on the toxicity prediction satisfying a selection criteria which amount to certain methods of organizing human activity for the same reasons as the independent claims. Claim 5 includes evaluating the toxicity prediction in comparison with the efficacy prediction to generate the indication and configure the treatment plan, which amount to certain methods of organizing human activity for the same reasons as the independent claims. Claims 6-13 and 15 further specify or limit the independent claims and are therefore directed to the same abstract ideas. Claim 14 includes re-evaluating the patient using updated healthcare data and updated toxicity-related model which falls into the abstract grouping of certain methods of organizing human activity because it is activity performed by a physician in treating a patient. 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.
Response to Arguments
Applicant’s arguments, see Page 9, “Claim Objections”, filed 07/20/2026 with respect to claims 5 and 73 have been fully considered and they are persuasive. Therefore, the objections of 04/23/2026 have been withdrawn.
Applicant’s arguments, see Pages 9-12, “Claim Rejections - 35 U.S.C. 101”, filed 07/20/2026 with respect to claims 1-17 and 71-73 have been fully considered but they are not persuasive.
Applicant argues that the claims are not directed to an abstract idea because they do not recite certain methods of organizing human activity. Applicant argues that instead the claims govern the configuration and behavior of predictive models and the actions triggered by their outputs. Additionally, Applicant argues that the claims do not recite a mental process. Specifically, Applicant argues that the operations of the claims require the trained, selected model and its associated precision/recall behavior which cannot be performed in the human mind. Examiner respectfully disagrees. The claims recite the models at a very high-level of generality, as a toxicity-related model, which does not specify any particular model and therefore, the model could be one that is configured and/or executed by a person. Additionally, the use of predictive models, when they are recited at a high-level of generality, to apply the steps of the abstract idea such as generating a toxicity prediction and configuring a treatment plan, amounts to mere instructions to apply the exception, as per MPEP 2106.05(f)(2).
Applicant argues that the claims integrate the abstract idea into a practical application because the claims recite configuring a treatment plan to include immunotherapy by determining a schedule for application of the immunotherapy to the patient and provisioning patient monitoring to evaluate the patient during execution of the treatment plan, which Applicant asserts that these steps apply the model output in a specific manner to a patient’s care. Examiner respectfully disagrees. The steps of configuring a treatment plan to include immunotherapy by determining a schedule for application of the immunotherapy and provisioning patient monitoring to evaluate the patient during the treatment plan are performed by a physician in the treatment of a patient. Therefore, these steps are directed to certain methods of organizing human activity. Because they are directed to the abstract idea itself, they are not additional elements which integrate the abstract idea into a practical application.
Applicant argues that the claims analogous to Example 45 and Example 46, claim 2 because the claimed determination of an application schedule and the provisioning of patient monitoring constitute other meaningful limitations that apply the alleged exception. Examiner respectfully disagrees. As discussed above, the determination of an application schedule and provisioning of patient monitoring are directed to the abstract idea itself, because determining a schedule of application of immunotherapy and provisioning patient monitoring is activity performed by a physician during interactions with a patient. Activity of a physician interacting with a patient falls into the abstract grouping of certain methods of organizing human activity. Because they are directed to the abstract idea itself, they are not additional elements and therefore do not constitute other meaningful limitations.
Applicant argues that the claims set forth an ordered combination that is not a generic or conventional arrangement. Examiner notes that only elements which are insignificant extra-solution activity require evidence of whether they are well-understood, routine, and conventional activity. The steps which Applicant cites to including selecting a toxicity-related model using model selection criterion, determining a distinct patient selection criterion that sets a balance between precision and recall for action on the model output, generating a patient-specific toxicity prediction, and configuring a treatment plan that includes a determined application schedule and provisioned patient monitoring are part of the abstract idea and not additional elements which are insignificant extra-solution activity. Therefore, these steps are not analyzed as to whether or not they are well-understood, routine, and conventional and do not amount to significantly more than the abstract idea.
Applicant’s arguments, see Pages 12-15, “Claim Rejections - 35 U.S.C. 103”, filed 07/20/2026 with respect to claims 1-17 and 71-73 have been fully considered and they are persuasive. Therefore, the rejection of 04/23/2026 has been withdrawn.
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
