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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 27, 2026 has been entered.
Status of the Claims
The office action is in response to the claim amendments and remarks filed on November 17 for the application filed March 8, 2024 which claims priority to a provisional application filed on September 28, 2016. Claims 1, 8, 15 and 22 have been amended and claims 14 and 17 have been cancelled. Claims 1-13, 15-16 and 18-22 are currently pending and have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-13, 15-16 and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Clam recite 8 “wherein the instructions cause the one or more processors to:… administering a pharmaceutical combination of medication to one or more subjects…”. There is insufficient written description support for this limitation in the specification. While the specification discloses modifying the care plan with pharmaceutical combinations and performing scheduling, reserving or ordering based on the modified care plan which may inherently cover administering the pharmaceutical combination based on the scheduling, reserving or ordering, there is no description of a instructions that cause the one or more processors to physically administer the pharmaceutical combination.
Claims 9-13 are rejected based on their dependency on claim 8.
Clam recite 15 “causes the one or more processors to perform operations comprising:… administering a pharmaceutical combination of medication to one or more subjects…”. There is insufficient written description support for this limitation in the specification. While the specification discloses modifying the care plan with pharmaceutical combinations and performing scheduling, reserving or ordering based on the modified care plan which may inherently cover administering the pharmaceutical combination based on the scheduling, reserving or ordering, there is no description of causing the one or more processors to physically administer the pharmaceutical combination.
Claims 16 and 18-20 are rejected based on their dependency on claim 15.
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 1-13, 15-16 and 18-21 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.
Eligibility Step 1:
Under step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, claims 1-8 and 21 are directed towards a method (i.e. a process), which is a statutory category. Claims 8-13 are directed towards a system (i.e. a machine), which is a statutory category. Claims 15-16 and 18-20 are directed towards a non-transitory computer readable media (i.e. a manufacture), which is a statutory category. Since the claims are directed toward statutory categories, it must be determined if the claims are directed towards a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea). In the instant application, the claims are directed towards an abstract idea.
Eligibility Step 2A, Prong One:
Under step 2A, prong one of the 2019 Revised Patent Subject Matter Eligibility Guidance, independent claims 1, 8 and 15 are determined to be directed to an judicial exception because an abstract idea is recited in the claims which fall within the subject matter groupings of abstract ideas. The abstract idea (identified in bold) recited in the representative claim 8 is identified as:
A system for automatically predicting relapse or non-adherence in an individual subject based on a predictive model, the system comprising:
a memory configured to store computer-executable instructions; and
one or more processors in communication with the memory, wherein the instructions cause the one or more processors to:
select the individual subject for predicting relapse or non-adherence;
select a cohort of subjects with known relapse statuses in which there is a known relapse event;
retrieve the predictive model and corresponding model variables, the corresponding model variables determined from dimensionally reduced values extracted from electronic health records associated with the cohort of subjects with known relapse statuses, wherein each model variable of the corresponding model variables is associated with a coefficient determined by multiplicative Cox Proportional Hazards relative survival regression;
receive a health record information corresponding to the individual subject, and extracting values for the model corresponding to the model variables from the health record information of the individual,
wherein the health record information is received based on a biometric authentication procedure with a data source comprising the health record information in order to obtain authenticated data;
standardize health historical values using one or more processors to symmetrize and deskew distributions of ratio-scale or interval-scale variables from the extracted model variable values;
utilize the predictive model and ratio-scale or interval-scale variables to determine a prediction for a likelihood of relapse for the individual subject; and
responsive to the predicted likelihood of relapse exceeding the predetermined threshold, automatically modify a care plan for the individual subject and providing the determined likelihood of relapse prediction to a caregiver associated with the individual subject via a notification,
administering a pharmaceutical combination of medication to one or more subjected with likelihood of relapse based at least in part on the modified care plan.
The limitations of “wherein each model variable of the corresponding model variables is associated with a coefficient determined by multiplicative Cox Proportional Hazards relative survival regression” and “standardize health historical values … to symmetrize and deskew distributions of ratio-scale or interval-scale variables from the extracted model variable values” fall within the subject matter grouping of mathematical concepts, such as mathematical relationships, mathematical formulas or equations, and mathematical calculations. Determining the model variables and coefficients involves the specific mathematical calculation (multiplicative Cox Proportional Hazards relative survival regression) and therefore encompasses mathematical concepts. The plain meaning of standardize to symmetrize and deskew distributions, as explained in paragraph [0064] of the specification, includes applying suitable transformations such as power-law or logarithmic transforms, which are techniques using mathematical calculations, and therefore encompasses mathematical concepts. See MPEP §2106.04(a)(2)(I).
The limitations of “select the individual…”, “select a cohort…”, “the corresponding model variables determined from dimensionally reduced values extracted from electronic health records…”, “wherein the health record information is received based on a biometric authentication procedure with a data source comprising the health record information in order to obtain authenticated data”, “utilize the predictive model and ratio-scale or interval-scale variables to determine a prediction for a likelihood of relapse for the individual subject”, “responsive to the predicted likelihood of relapse exceeding the predetermined threshold, … modify a care plan for the individual subject” and “wherein medication is administered to one or more subjected with likelihood of relapse based at least in part on the modified care plan” fall within the subject matter grouping of mental processes. Selecting, individuals and cohorts are judgments which can performed in the human mind. Performing a biometric authentication procedure with a data source to obtain authenticated data can also be performed in the human mind using observations, evaluations, judgments and opinions. The claims place no limits on the predictive model such that utilizing the predictive model to determine a prediction involves observations, evaluations, judgments and opinions which can be performed in the human mind. Modifying a care plan responsive to the predicted likelihood of relapse exceeding the predetermined threshold can also be performed using observations, evaluations judgments and opinions. If a claim recites limitations that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitations falls within the mental processes grouping, and the claim recites an abstract idea. See MPEP §2106.04(a)(2)(III).
Accordingly, claims 1, 8 and 15 recite an abstract idea under step 2A, prong one.
Eligibility Step 2A, Prong Two:
Under step 2A, prong two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the identified abstract ideas are integrated into a practical application. After evaluation, there is no indication that any additional elements or combination of elements integrate the abstract idea into a practical application, such as through: an additional element that reflects an improvement to the functioning of a computer, or an improvements to any other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element that implements the judicial exception with, or uses the judicial exception in connection with, a particular machine or manufacture that is integral to the claim; an additional element that effects a transformation or reduction of a particular article to a different state or thing; or an additional element that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. As shown below, the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than a recitation of: generally linking the abstract idea to a particular technological environment or field of use; insignificant extra-solution activity to the judicial exception; and/or adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea as evidenced below.
The additional elements recited in representative claim 8 are identified in bold as:
a memory configured to store computer-executable instructions; and
one or more processors in communication with the memory, wherein the instructions cause the one or more processors to:
select the individual subject for predicting relapse or non-adherence;
select a cohort of subjects with known relapse statuses in which there is a known relapse event;
retrieve the predictive model and corresponding model variables, the corresponding model variables determined from dimensionally reduced values extracted from electronic health records associated with the cohort of subjects with known relapse statuses, wherein each model variable of the corresponding model variables is associated with a coefficient determined by multiplicative Cox Proportional Hazards relative survival regression;
receive a health record information corresponding to the individual subject, and extracting values for the model corresponding to the model variables from the health record information of the individual,
wherein the health record information is received based on a biometric authentication procedure with a data source comprising the health record information in order to obtain authenticated data;
standardize health historical values using one or more processors to symmetrize and deskew distributions of ratio-scale or interval-scale variables from the extracted model variable values;
utilize the predictive model and ratio-scale or interval-scale variables to determine a prediction for a likelihood of relapse for the individual subject; and
responsive to the predicted likelihood of relapse exceeding the predetermined threshold, automatically modify a care plan for the individual subject and providing the determined likelihood of relapse prediction to a caregiver associated with the individual subject via a notification,
administering a pharmaceutical combination of medication to one or more subjected with likelihood of relapse based at least in part on the modified care plan.
The additional limitations of “a memory configured to store computer-executable instructions; one or more processors in communication with the memory, wherein the instructions cause the one or more processors to” and “automatically” are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f). The processor and memory are recited at a high level of generality and are used merely as a tool to perform the abstract idea. The term “automatically” does not specify how the action is performed and therefore merely implies that that the memory and processor perform the modification, such that memory and processor are used to perform the abstract idea. Therefore, these additional elements amount to no more than a recitation of the words "apply it" (or an equivalent) or no more than mere instructions to implement an abstract idea or other exception on a computer or no more than merely using a computer as a tool to perform an abstract idea.
The additional limitations of “retrieve the predictive model and corresponding model variables”, “receive a health record information corresponding to the individual subject” and “providing the determined likelihood of relapse prediction to a caregiver associated with the individual subject via a notification” are determined to be no more than insignificant extra-solution activity to the judicial exception under MPEP §2106.05(g). The retrieval of the model, variables and the receiving of the health record information is mere necessary data gathering required to perform the abstract idea. The providing of the notification is mere insignificant extra solution data outputting, such as providing the determined likelihood after determining the likelihood.
The additional limitation of “administering a pharmaceutical combination of medication to one or more subjected with likelihood of relapse based at least in part on the modified care plan” recites administering a generic “medication” which is not particular and is therefore amounts to mere instructions to "apply" the exception in a generic way which does not integrate the mental analysis steps into a practical application. See MPEP §2106.04(d)(2). This step can be considered to be the insignificant extra-solution activity of mere application to the judicial exception under MPEP §2106.05(g), such as administering a medication according to a modified care plan after modifying the care plan to specify the medication to be administered.
Accordingly, claims 1, 8 and 15 do not recite additional elements which integrate the abstract idea into a practical application.
Eligibility Step 2B:
Under step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether provide an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. After evaluation, there is no indication that an additional element or combination of elements are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitations are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f) and insignificant extra-solution activity to the judicial exception under MPEP §2106.05(g). It is also determined that receiving/retrieving data and transmitting/providing data in the computing environment is well-understood routine and conventional as evidenced by MPEP §2106.05(d), subsection II.
Furthermore, 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 amounts to an inventive concept.
Dependent Claims:
The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above.
Dependent claims 2, 9 and 16 recite a comparing the prediction to a threshold and determining to issue a notification if the threshold is satisfied, which involve observation, evaluation and judgments which can be performed din the human mind such that it is encompassed by the a mental process grouping of abstract ideas and an issuing a notification step which is the insignificant extra-solution activity of mere data outputting that is well-understood, routine and conventional as detailed above. Dependent claims 3, 10 and 16-17 merely provide additional details of the threshold and notification and do not impose meaningful limits on the claims which alter the analysis.
Dependent claims 4, 11 and 18 recite actions which are typically performed by a human, such as scheduling interventions and modifying care plans. These can be done mental with the aid of pen and paper such that they are directed to the mental process grouping of abstract ideas. These limitations can also fall with the grouping of certain methods of organizing human activity and these actions are human activities. The term “automatically” implies that the processor and memory perform the action which is considered to be mere instructions to apply an abstract idea under MPEP §2106.05(f).
Dependent claims 5, 12 and 19 merely provide additional details of the care plan that do not impose meaningful limits on the claims which alter the analysis.
Dependent claims 6-7, 13 and 20 recite details of the standardization which involve mathematical calculations and performing LASSO regression with a specific penalty function, which are specific mathematical calculations, which are encompassed by the mathematical concepts grouping of abstract ideas.
Claim 21 recites high level biometric authentication techniques at a high level of generality and used in there ordinary capacity and are therefore determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f).
None of these limitations are deemed to integrate the claims into a practical application or to amount to significantly more than the abstract idea because, as detailed above.
Therefore, whether taken individually or as an ordered combination, 1-13, 15-16 and 18-21 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Allowable Subject Matter
Claim 22 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding the previous rejection under 35 U.S.C. §101, the claims 1 and 22 have been amended positively recite the administering step and to only cover particular treatments which are related to treating symptoms of relapse and are therefore have a significant relationship to the identified abstract idea of predicting a likelihood of relapse of an individual subject.
Response to Arguments
Applicant's arguments filed March 27, 2026 regarding claims 1-13, 15-16 and 18-22 being rejected under 35 U.S.C. §101 have been fully considered but they are not persuasive.
Applicant argues under step 2A, prong 1 that the use of the predictive model in claims 1, 8 and 15 cannot be performed in the human mind by pointing to the “Reminders on evaluating subject matter eligibility of claims under 35 U.S.C. 101” dated August 4, 2025, which states the claim limitations that encompass AI in a way that cannot be practically performed in the human mind do not dal within the grouping of mental processes.
In response, claims 1, 8 and 15 do not encompass AI in a way that cannot be practically performed in the human mind. The prediction model does not necessarily encompass AI as the claims only require a retrieving and utilizing a model having variables and coefficients. Utilizing a prebuilt model with input variables and coefficients to calculate a prediction can be performed in the human mind with the aid of pen and paper and does not encompass machine learning techniques which cannot be practically performed in the human mind. Furthermore, the coefficients are determined through multiplicative Cox Proportional Hazards relative survival regression which are specific mathematical formulas or equations for performing mathematical calculations and is directed to the abstract idea of mathematical concepts.
Applicant argues under step 2A, prong 2 that paragraphs [0006], [0007], [0026], [0060] and [0070] of the specification describe improvements provided by an example embodiment and describes a practical application.
In response, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. If the specification sets forth an improvement in technology, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement. That is, the claim includes the components or steps of the invention that provide the improvement described in the specification.
The highlighted portions of paragraphs [0006] and [0007] only recite the desired outcome/functionality of the invention without out any details about how the outcomes/functionality is accomplished which could amount to improvement in technology.
The highlighted portions paragraph [0026] asserts the needs for the improved systems and methods of the claims, however, the improvement as claimed appears to be a result of the automation of the abstract idea itself and the mere automation is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f).
The highlighted portions paragraph [0060] merely describes retrieving and logging information without any details which could be considered an improvement to technology..
The highlighted portions paragraph [0070] only recites the desired outcome/functionality of the invention without out any details about how the outcomes/functionality is accomplished which could amount to improvement in technology.
Applicant argues that the claims recite a customized treatment for relapse and provides a particular manner or type of treatment, such that the claims as whole integrates the judicial exception into a practical application.
The additional limitation of “administering a pharmaceutical combination of medication to one or more subjected with likelihood of relapse based at least in part on the modified care plan” does not recite administering a particular medication as the medication can be any medication. Thus, the administering step does not integrate the abstract idea into a practical application. See MPEP §2106.04(d)(2).
Conclusion
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/DEVIN C HEIN/Examiner, Art Unit 3686
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