DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 1, 4, 6-10, 13, 15-17, & 20 were previously pending in this application. The amendment filed 13 July 2026 has been entered and the following has occurred: Claims 1, 10, & 17 have been amended. No claims have been cancelled or added.
Claims 1, 4, 6-10, 13, 15-17, & 20 remain pending in the application.
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, 4, 6-10, 13, 15-17, & 20 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.
The claims recite subject matter within a statutory category as a process (claims 1, 4, 6-9), machine (claims 10, 13, 15-16), and manufacture (claims 17 & 20) which recite steps of:
inputting a plurality of patient data for a patient into a multi-model framework, wherein the patient data includes the patient’s clinical data and geographic information, wherein the multi-model framework comprises a Bayesian statistical model configured to analyze a plurality of predictions for each of a plurality of treatment response models in a context of at least one target patient outcome, and wherein a prior state of knowledge is encoded into a prior probability distribution as a parameter set for each model;
predicting, for each of the plurality of treatment response models and using the multi-model framework to maximize a patient-specific fitness function, a probability of a given treatment corresponding with each of the plurality of treatment response models producing the at least one target patient outcome, wherein the predictions for each of the plurality of treatment response models is continuously updated in response to receiving new data relating to the state of prior knowledge, and wherein the patient-specific fitness function is maximized according to:
Pr
S
D
,
I
=
Pr
s
I
P
r
(
D
|
S
,
I
)
P
r
(
D
|
I
)
where:
S is a clinical hypothesis of interest;
D represents patient-specific data;
I represents prior acquired information; and
Pr (D|I) is a normalization constant;
responsive to receiving a request, outputting an assessment for each given treatment;
determining a treatment with a highest likelihood of success for the patient; and
administering treatment for the patient in accordance with the determined treatment with the highest likelihood of success, wherein the determined treatment comprises surgery, radiotherapy, chemotherapy, immunotherapy, psychological support, or combinations thereof, and wherein the surgery comprises a lumpectomy, mastectomy, and/or implant placement.
These steps of inputting a plurality of patient data for a patient into a multi-model framework containing a Bayesian statistical model for analyzing predictions for treatment response models corresponding to a target patient outcome, predicting, using the multi-model framework, a probability of a given treatment producing a given outcome for the patient and maximizing a patient-specific fitness function according to the function recited in the independent claims, outputting an assessment for each given treatment option, determining a treatment with a highest likelihood of success for the patient from the outputted given treatment options, directing treatment according to various forms of treatment such as surgery, radiotherapy, etc., as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. MPEP 2106.04(a)(2)(II) describes certain methods of organizing human activity, such as fundamental economic principles or practices, commercial or legal interactions, managing personal behavior or relationships or interactions between people. In particular, managing personal behavior or relationships or interactions between people can specifically include social activities, teaching, and following rules or instructions. The enumerated steps above amount to managing personal behavior or relationships or interactions between people. For instance, the typical interaction that occurs between a patient receiving a treatment and a doctor or medical entity for assigning said treatment is effectively being managed by the performance of the steps, such as on a computer or via a computerized means with a multi-model, statistical framework calculating treatment effects. In particular, the system outputs an assessment, i.e. recommendation for certain rules or instructions to follow for implementing a treatment for the patient, wherein the outputted treatment with the highest likelihood of success is used to direct treatment for the patient. Therefore, the steps recited in the claims amount to methods of organizing human activity, under broadest reasonable interpretation.
The claims recite a mathematical formula. Therefore, the claims are also abstract under Mathematical Concepts grouping of abstract ideas under broadest reasonable interpretation.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 4, 6-9, 13, 15-16, & 20, reciting particular aspects of how assessing the given treatment, receiving data, and/or recommending a treatment may be performed in the mind but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of a multi-model framework, a processor, a memory, a computer program code for at least one program, a network interface, a non-transitory computer-readable storage medium, a computer/computing entity, amounts to invoking computers as a tool to perform the abstract idea, see applicant’s specification [0032] & [0072]-[0076] for a multi-model framework, [0061] for a processor/processing unit, [0061] for a memory, [0064] for a computer program code for at least one program, [0060] for a network interface, [0063] for a non-transitory computer-readable storage medium, [0060] for a computer/computing entity, see MPEP 2106.05(f));
add insignificant extra-solution activity to the abstract idea (such as recitation of inputting a plurality of patient data for a patient into a multi-model framework, wherein the patient data includes the patient’s clinical data and geographic information amounts to mere data gathering, recitation of predicting a probability of a given treatment corresponding with each of the plurality of treatment response models producing the at least one target patient outcome, wherein the predictions for each of the plurality of treatment response models is continuously updated in response to receiving new data relating to the state of prior knowledge and producing an assessment for the given treatment amounts to selecting a particular data source or type of data to be manipulated, recitation of outputting an assessment for the given treatment, determining a treatment with the highest likelihood of success for the patient and using said treatment to direct treatment for the patient (i.e. it should be further noted that while the independent claims specify “directing treatment”, this directed treatment is not actually ever effectuated under BRI of the steps recited, and could potentially constitute a practical application if the claims were amended to recite effectuation/executing the actual treatments by the system, such as via a treatment device/component, versus merely “directing treatment” and/or “administering the given treatment to the patient” as in dependent claim 9, depending on specific claim language/wording and if Applicant has support for such amendments in Applicant’s Specification), maximizing a patient-specific fitness function maximized according to the formula recited in the independent claims amounts to insignificant application, see MPEP 2106.05(g));
generally link the abstract idea to a particular technological environment or field of use (such as recitation of the methods for tumor forecasting in particular, and/or reciting varying fields of uses such as the determined treatments comprising surgery, radiotherapy, chemotherapy, immunotherapy, psychological support, or combinations thereof, see MPEP 2106.05(h)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 4, 6-9, 13, 15-16, & 20, which recite limitations relating to a multi-model framework, i.e. Bayesian statistical model, and/or a cloud-computing service/configuration, additional limitations which amount to invoking computers as a tool to perform the abstract idea; claims 4, 6, 13, & 20, which recite limitations relating to specifying forms of patient data received and/or treatment types/parameters, and/or data output types such as tumor burden, tumor local control, etc., additional limitations which add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering; claim 8, which recite limitations relating to analyzing respective predictions of a plurality of models of the multi-model framework and/or recommending a given treatment based on the analysis performed, additional limitations which add insignificant extra-solution activity to the abstract idea by selecting a particular data source or type of data to be manipulated; claims 7, 9, 16, & 20, which recite limitations relating to different types of treatments relating to cancer, the model framework being implemented as a cloud-computing service, and/or recommending/administering varying types of cancer treatments additional limitations which generally link the abstract idea to a particular technological environment or field of use). 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 a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as inputting a plurality of patient data for a patient into a multi-model framework, wherein the patient data includes the patient’s clinical data and geographic information, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); predicting a probability of a given treatment corresponding with each of the plurality of treatment response models producing the at least one target patient outcome, wherein the predictions for each of the plurality of treatment response models is continuously updated in response to receiving new data relating to the state of prior knowledge and producing an assessment for the given treatment, determining a treatment with the highest likelihood of success for the patient and using said treatment to direct treatment for the patient, maximizing a patient-specific fitness function maximized according to the formula recited in the independent claims, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii); maintaining records of patient data for collection/input into the multi-model framework, maintaining one or more parameters or models of the Bayesian statistical model or other models in the multi-model framework, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii); storing patient data, storing a multi-model framework, storing a prediction result and/or assessment for a given treatment/patient, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv); outputting the results of the assessment for the given treatment and/or instructions for administering treatment according to the given treatment and/or instructing for a type of treatment such as surgery, radiotherapy, chemotherapy, immunotherapy, psychological support, or combinations thereof and/or the surgery comprising a lumpectomy, mastectomy, and/or implant placement, limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to related data, Electric Power Group, LLC v. Alstom S.A., MPEP 2106.05(h), i.e. the broadest reasonable interpretation of “administering treatment” without further specifying said modes of “administering” in the disclosure/specification includes several interpretations including facilitating, such as managing or being responsible for running, dispensing or applying, or giving help or service, that is, while dispensing or applying may constitute a practical application or significantly more, the aspects of managing or being responsible for running and/or giving help or service do not constitute a practical application or significantly more, and therefore under broadest reasonable interpretation, do not necessarily constitute a practical application or significantly more based on the plain meaning of “administering”; applying a multi-model framework comprising a Bayesian statistical model, i.e. applying one or more computational models, such as Bayesian network or other statistical computational model, for determination of cancer treatment responsiveness, see Rico Table 2 and Par [0204], see Hall Par [0259]).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 4, 6-9, 13, 15-16, & 20, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 4, 6, 13, & 20, which recite limitations relating to specifying forms of patient data received and/or treatment types/parameters, and/or data output types such as tumor burden, tumor local control, etc., e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); claim 8, which recite limitations relating to analyzing respective predictions of a plurality of models of the multi-model framework and/or recommending a given treatment based on the analysis performed, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii); claims 7, 9, 16, & 20, which recite limitations relating to maintaining and updating parameters for different types of treatments that are recommended/administered relating to cancer, maintaining one or more communication networks, i.e. as a cloud-computing service, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii); claims 4, 6-9, 13, 15-16, & 20, which generally recite limitations relating to storing computerized instructions in memory to perform the methods recited, storing one or more model frameworks or patient-specific fitness functions, storing one or more patient data, etc., e.g., storing and retrieving information in memory, Versata Dev. Group, 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 a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Response to Arguments
Applicant's arguments filed 03 September 2025 have been fully considered but they are not persuasive:
Regarding 35 U.S.C. 101 rejections of claims 1, 4, 6-10, 13, 15-17, & 20, Applicant argues on p. 8 of Arguments/Remarks that independent claim 1 applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition which integrates the exception into a practical application in accordance with the 2019 Revised Patent Subject Matter Eligibility Guidance. More specifically, Applicant argues that the newly amended “administering treatment… wherein the surgery comprises a lumpectomy, mastectomy, and/or implant placement” specifically amounts to said particular treatment or prophylaxis. Examiner respectfully disagrees with Applicant’s arguments. The requirements for particular treatment or prophylaxis as a practical application of an abstract idea include a particular disease/condition and associated particular, singular treatment to be elected in the claims instead of arriving at one or more treatments that are most effective for one or more conditions. For example, independent claims elect the potential treatments of surgery, radiotherapy, chemotherapy, immunotherapy, psychological support, OR combinations thereof rather than a singular treatment to be administered to the patient. Furthermore, multiple modes of treatment or By way of example, Examiner points to Example 49 of the 2024 Subject Matter Eligibility Examples, where Claim 1 of Example 49 "does not provide any information as to how the patient is to be treated or what the treatment is, but instead covers any possible treatment that a medical professional decides to administer to the patient” as a result of applied computational modeling, which is similar to the newly amended limitations found in the independent claims. However, if a specific treatment was elected and administered, similar to claim 2 of Example 49, this may support the argument of particular treatment or prophylaxis. However, in their current state, the independent claims do not represent a particular treatment or prophylaxis since any possible treatment of the potential, elected treatments is covered by the verbiage of the claims. Furthermore, the broadest reasonable interpretation of “administering treatment” without further specifying said modes of “administering” in the disclosure/specification includes several interpretations including facilitating, such as managing or being responsible for running, dispensing or applying, or giving help or service, that is, while dispensing or applying may constitute a practical application or significantly more, the aspects of managing or being responsible for running and/or giving help or service do not constitute a practical application or significantly more, and therefore under broadest reasonable interpretation, do not necessarily constitute a practical application or significantly more based on the plain meaning of “administering”. As such, claims 1, 4, 6-10, 13, 15-17, & 20 remain rejected under 35 U.S.C. 101.
Regarding 35 U.S.C. 101 rejections of claims 1, 4, 6-10, 13, 15-17, & 20, Applicant argues on p. 8 of Arguments/Remarks that independent claims 10 & 17 recite similar subject matter to independent claim 1 and therefore recite eligible subject matter for the same reasons as claim 1. Applicant additionally argues that dependent claims 4, 6-9, 13, 15-16, & 20 are dependent from independent claims 1, 10 & 17 and therefore also recite eligible subject matter by virtue of dependency. Examiner respectfully disagrees with Applicant’s arguments. As discussed above, independent claim 1 does not represent or recite eligible subject matter. Therefore, Applicant’s arguments regarding independent claims 10 & 17 reciting similar subject matter to independent claim 1 and/or dependent claims 4-9, 13-16, & 20-21 being dependent from independent claims 1, 10 & 17 reciting eligible subject matter are rendered moot, because independent claim 1 does not represent or recite eligible subject matter, as discussed above. As such, claims 1, 4, 6-10, 13, 15-17, & 20 remain rejected under 35 U.S.C. 101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Freese et al. (U.S. Patent Publication No. 2021/0134394) discloses a system for inputting a test feature vector containing counts of endpoint fragments from a test sample to the classifier, which generates a cancer prediction describing a likelihood the test sample has cancer and/or is of a particular cancer type;
Ki et al. (U.S. Patent Publication No. 2023/0183812) discloses a system for automated diagnosis of cancer and prediction of cancer type, such that a model is developed from Bayesian optimization and the configuration of the model may vary depending on the data used and optimization of the model;
Jang et al. (U.S. Patent No. 10,971,268) discloses a system for applying a Bayesian conditional probability to the Bayesian network; and deriving a probability of getting pancreatic cancer when there is a specific symptom from the pancreatic cancer patient.
Applicant's amendment necessitated the new ground of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/H.R./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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