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 .
This communication is in response to the amendment received on 10/21/2025. Claims 1-20 remain pending in this 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-20 are drawn to a method which is within the four statutory categories (i.e. process).
Step 2A, Prong 1:
The independent claims have been amended to recite “during a first time period: for each user in a population of users: accessing, by at least one processor of a computer system associated with the user, clinical assessment for depression in the user; accessing, by the at least one processor, a first set of biosignal data, of the user, preceding the clinical assessment for depression; accessing, by the at least one processor, a first set of motion data, of the user, preceding the clinical assessment for depression; transforming, by the at least one processor, the first set of biosignal data into a first set of psychophysiological markers, the first set of psychophysiological markers comprising emotions exhibited by the user; and deriving, by the at least one processor, a set of correlations between: the first set of psychophysiological markers and the clinical assessment for depression; and the first set of motion data and the clinical assessment for depression; and compiling, by the at least one processor, sets of correlations, derived for the population of users, into a depression model including a trained machine learning or artificial intelligence process configured to predict risk of future depression diagnosis based on historical psychophysiological markers and historical motion data; and during a second time period: accessing, by the at least one processor, a first series of biosignal data collected by a wearable device worn by a first user and communicatively coupled with the computer system; accessing, by the at least one processor, a first series of motion data of the first user; transforming, by the at least one processor, the first series of biosignal data into a first series of psychophysiological markers; accessing, by the at least one processor, a target time window; prior to presentation of a set of depression symptoms by the first user, calculating, by the at least one processor, a first risk score representing presentation of the set of depression symptoms by the first user within the target time window based on the first series of psychophysiological markers, the first series of motion data, and the depression model; in response to the first risk score exceeding a threshold risk, populating, by the at least one processor, a notification with: the first risk score; and a prompt to investigate the first user for prescription of a first dose of an pharmacological medication; and serving, by the at least one processor, the notification to a care provider associated with the first user”-claim 1, “…accessing, by the at least one processor, a risk threshold; prior to presentation of a set of depression symptoms by the first user: calculating, by the at least one processor, a first time associated with a risk of presentation of the set of depression symptoms by the first user based on the first series of psychophysiological markers and the depression model, the risk exceeding the risk threshold; and calculating, by the at least one processor, a first time duration between the first time and a current time; and in response to the first time duration falling below a threshold duration: populating, by the at least one processor, a notification with: the first time duration; and a prompt to investigate the first user for prescription of a first dose of an pharmacological medication;…”-claim 13, and claim 19 recites similar limitations.
These limitations correspond to an abstract idea of “certain methods of organizing human activity” with a recitation of generic processor. This is a method of managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic processor, wearable device and a computing device does not take the claims out of the methods of organizing human interactions grouping. Thus, the claims recite an abstract idea.
The dependent claims also recite limitations that are directed to “certain methods of organizing human activities”, thus an abstract idea. The limitations corresponding to the abstract idea, such as user following rules and instructions are:
“Claim 2: “during the first time period: for each user in the population of users: accessing, by the at least one processor, a set of self-assessments of depression symptoms generated by the user; and extracting, by the at least one processor, a series of depression symptom severities from the set of self-assessments; wherein deriving the set of correlations comprises deriving, by the at least one processor, the set of correlations further between: the first set of psychophysiological markers and the series of depression symptom severities; and the first set of motion data and the series of depression symptom severities;…generating, by the at least one processor, the depression model configured to predict risk of future depression diagnosis and future depression symptom severity based on historical psychophysiological markers and historical motion data; further comprising accessing, by the at least one processor, a threshold depression symptom severity; and wherein calculating the first risk score comprises: prior to presentation of depression symptom severity, greater than the threshold depression symptom severity, by the first user: calculating, by the at least one processor, the first risk score representing presentation of the set of depression symptoms, approximating the threshold depression symptom severity, by the first user within the target time window”,
Claim 3: “wherein accessing a first set of biosignal data for each user in the population of users comprises: accessing, by the at least one processor, a first subset of biosignals of a user”,
Claim 4: “for each user in the population of users: accessing, by the at least one processor, a first set of text communications generated by the user; and extracting, by the at least one processor, a first set of language signals from the first set of text communications; wherein deriving the set of correlations comprises deriving, by the at least one processor, the set of correlations further between: the first set of language signals and the clinical assessment for depression; and further comprising, during the second time period: accessing, by the at least one processor, a first series of text communications generated by the first user; and extracting, by the at least one processor, a first series set of language signals from the first set of text communications; and wherein calculating the first risk score comprises calculating, by the at least one processor, the first risk score further based on the first series set of language signals”,
Claim 7: “accessing, by the at least one processor, an initial set of psychophysiological markers derived from a series of health evaluations executed by the care provider for the first user and representative of a set of health indicators for the first user; generating, by the at least one processor, a second emotion model linking biosignals to psychophysiological markers for the first user based on the initial set of biosignal data and the initial set of psychophysical markers”,
Claim 12: “wherein accessing the target time window comprises: setting the target time window based on: historic responsiveness of the first user to the pharmacological medication; and anticipated effective period of the first dose of the pharmacological medication”,
Claim 14: “during the first time period: for each user in the population of users: accessing, by the at least one processor, a set of self-assessments of depression symptoms generated by the user; and extracting, by the at least one processor, a series of depression symptom severities from the set of self-assessments; wherein deriving the set of correlations comprises deriving, by the at least one processor, the set of correlations further between the first set of psychophysiological markers and the series of depression symptom severities;…generating, by the at least one processor, the depression model configured to predict risk of future depression diagnosis and future depression symptom severity based on set of psychophysical markers; further comprising accessing, by the at least one processor, a threshold depression symptom severity; and wherein calculating the first time duration comprises: prior to presentation of depression symptom severity, greater than the threshold depression symptom severity, by the first user: calculating, by the at least one processor, the first time duration associated with risk of presentation of the set of depression symptoms, approximating the threshold depression symptom severity, by the first user within the first time duration”,
Claim 16: "further comprising: accessing, by the at least one processor, a first medical record of the first user, the first medical record specifying non-clinically significant depressive anxiety symptoms of the first user",
Claim 17: “further comprising accessing, by the at least one processor, a first medical record of the first user, the first medical record specifying: a chronic depression diagnosis of the first user; and a current dose of the pharmacological medication prescribed to the first user”
Claim 18: “wherein calculating the first time duration comprises calculating, by the at least one processor, the first time associated with the risk of presentation of the set of depression symptoms by the first user exceeding the risk threshold, the set of depression symptoms: indiscernible to a nominal practicing physician during the first time duration; and visible to the nominal practicing physician after the first time”,
Claim 20: " further comprising: during the first time period: for each user in the population of users: accessing, by the at least one processor, a set of self-assessments of depression symptoms generated by the user; and extracting, by the at least one processor, a series of depression symptom severities from the set of self-assessments; wherein deriving the set of correlations comprises deriving, by the at least one processor, the set of correlations further between: the first set of biosignal data, the first set of motion data and the series of depression symptom severities”.
These limitations correspond to “certain methods of organizing human activity” (method of managing interactions between people, such as user following rules and instructions) with a recitation of generic computing devices, such at least one processor, a wearable device worn by a first user and a computing/mobile device carried by the first user. These devices are described in the current specification as generic computing devices (current specification; [0017]).
Claim have been amended to recite “compiling, by the at least one processor, sets of correlations, derived for the population of users, into a depression model including a trained machine learning or artificial intelligence process configured to predict risk of future depression diagnosis based on historical psychophysiological markers and historical motion data” in claims 1, 13, 19 and “generating, by the at least one processor, an emotion model including a trained machine learning or artificial intelligence process linking biosignals to psychophysiological markers for the first user based on the emotion- labeled set of biosignal data” and “predicting risk of future depression diagnosis using a trained machine learning model” corresponds to mathematical relationships, which falls within the “mathematical concepts” grouping of abstract ideas. The current specification recites “Then, the computer system can train a depression model (e.g., transformer deep neural network) to identify correlations (e.g., patterns) between user data - including the set of physiological biosignal data, the set of motion data, and the set of communication data - and the set of clinical evaluations. Therefore, the computer system can train the depression model to identify patterns in the user data that are correlated with clinical evaluations, which are indicative of the severity and quantity of depression symptoms exhibited by the user and observed by the care provider.” in [0023].
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Claims 2-12, 14-18 and 20 are ultimately dependent from claims 1, 13, 19 and include all the limitations of claims 1, 13, 19. Therefore, claims 2-12, 14-18 and 20 recite the same abstract idea. Claims 2-12, 14-18 and 20 describe a further limitation regarding the basis for determining the risk score for the user based on the collected data and the depression model. These are all just further describing the abstract idea recited in claims 1, 13, 19, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of: “at least one processor”, using the at least one processor to perform the accessing, transforming, deriving, compiling, converting, calculating, prompting, extracting, recording, labeling, generating, encrypting, setting, populating and serving steps.
These additional elements are directed to hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)). The additional elements amount no more than mere instructions to apply the exception using a generic computer component (the at least one processor).
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are 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. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computing device to perform accessing, transforming, compiling, calculating and serving notifications steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
Response to Arguments
Applicant's arguments filed 10/21/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed in the order in which they appear.
Applicant argues that the limitations of “accessing a clinical assessment for depression in the user”, “transforming the first set of biosignal data into a first set of psychophysiological markers”, and “compiling sets of correlation, derived for the population of users, into a depression model” is not one of the methods of organizing human activity deemed patent-ineligible by the 2019 Guidance.
In response, Examiner submits that these limitations correspond to a method of managing interactions between people, such as user following rules and instructions. MPEP recites “…the sub-groupings encompass both activity of a single person…and an activity involves multiple people…and thus, certain activity between a person and a computer…may fall within the “certain methods of organizing human activity” grouping” (MPEP 2106.04(a)(2) II). The mere nominal recitation of a generic processor, wearable device and a computing device does not take the claims out of the methods of organizing human interactions grouping.
Applicant argues that the independent claims, when considered as a whole, provide a specific, technological improvement to existing methods of detecting and assessing physiological conditions in a user, detecting and monitoring clinical depression and anxiety biomarkers from biosensors. Applicant argues that the existing methods of assessing anxiety and depression may not integrate biomarkers from biosensors associated with the user.
In response, Examiner submits that the current specification recites “Generally, Block S116 of the method S1oo recites: transforming the set of biosignal data into a set of psychophysiological markers, the set of psychophysiological markers representing metrics associated with mental health of the user in the population of users. Generally, in Block S116, the computer system can transform the set of biosignal data, such as heart rate variability data, skin temperature data, and/or respiratory rate data, into the set of psychophysiological markers representing various metrics indicative of the mental health of the user, such as instances of target emotion (e.g., sadness), sleep quality, social activity level, psychomotor activity level.” And “In one variation, the computer system can: transform the set of biosignal data into a set of psychophysiological markers, the set of psychophysiological markers representing emotions exhibited by the user in the population of users.” in [0043]-[0044]. These limitations correspond to mere instructions to apply the exception using a generic computer component, since there is no indication of a technological improvement neither in the claims nor in the current specification.
Applicant argues that the claims taken as a whole extend beyond any well-understood, routine and conventional or human-performable activities and represent a specific improvement to the existing methods for detecting and assessing psychological condition in a user, which do not integrate biomarkers from biosensors and claims represent “significantly more” than any alleged abstract idea.
In response, Examiner submits that, as indicated in the section above, neither the current claims nor the current specification recites any improvement in the technology. The current claims and the current specification recites “transforming, by the ate least one processor, the first set of biosignal data into a first set of psychophysiological markers” and “Generally, Block S116 of the method S1oo recites: transforming the set of biosignal data into a set of psychophysiological markers, the set of psychophysiological markers representing metrics associated with mental health of the user in the population of users. Generally, in Block S116, the computer system can transform the set of biosignal data, such as heart rate variability data, skin temperature data, and/or respiratory rate data, into the set of psychophysiological markers representing various metrics indicative of the mental health of the user, such as instances of target emotion (e.g., sadness), sleep quality, social activity level, psychomotor activity level.”. There is no indication of a technological improvement neither in the claims nor in the current specification.
Therefore, Applicant’s arguments are not persuasive and claims are rejected under 35 U.S.C. §101 as being directed to non-statutory subject matter.
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.
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687