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 Arguments
The objections to the claims have been withdrawn in part in light of the amendments to the claims, filed 06/09/26. Claims 21 and 24 remain objected to, as presented in detail below.
The rejections under 35 U.S.C. 112(b) have been withdrawn in part in light of the amendments to the claims, filed 06/09/26. Claim 1 (and its dependent claims by virtue of their dependencies) and claim 15 remain rejected under 35 U.S.C. 112(b), as presented in detail below.
Applicant’s arguments with respect to the rejection of the claims under 35 U.S.C. 101 have been fully considered but are not persuasive.
Applicant first argues that the claims do not recite a judicial exception because the claimed subject matter cannot practically be performed in the human mind (Remarks, filed 06/09/26, p. 22). Specifically, Applicant contends that updating a data model as claimed in the amended independent claims relies on sensor-generated physiological signals that cannot be perceived, generated, or processed in the human mind. Examiner respectfully disagrees. That is, a human could mentally update the model, which links gathered sensor data to instances of cognitive states exhibited by a user, by analyzing additional gathered data (second timeseries of biosignal data) and linking said data to observed user progress. The Specification provides no indication that the updating of the user model entails processing that cannot be performed in the human mind (see, e.g., Specification, [0047] & [0053], simply noting that gathered data (i.e., sensed data, results of a cognitive exercise/evaluation, comparison of results of cognitive exercises at different times) can broadly be used to “update the ADHD model of the user”). Applicant further argues that comparing user data to a “global model” requires a machine-implemented model (Remarks, filed 06/09/26, p. 22). Examiner respectfully disagrees. That is, the comparison of gathered user data to a global model which correlates results of cognitive evaluations and biosignal data to cognitive states of users diagnosed with ADHD does not inherently require the use of machine learning. Rather, other techniques can be employed, such as matching user data to a lookup table or statistical distribution. In fact, the Specification admits that the characterization of a correlation between user biosignal data and biosignal data of users diagnosed with ADHD based on the global ADHD model may be done via “regression, machine learning, deep leaning, and/or other techniques to derive links or correlations” (Specification, [0028]). Further, Applicant argues that deriving a cognitive state model as claimed cannot be performing in the human mind. Examiner respectfully disagrees. For example, a human can mentally correlate gathered biosignal data to observed user behavior/instances of cognitive states exhibited by the user during performance of cognitive evaluation.
Applicant next argues that the amended claims are integrated into a practical application of patient care (Remarks, filed 06/09/26, pp. 23-24, citing Vanda Pharm v. West-Ward, 887 F.3d 1117, 1135 (Fed. Cir. 2018)). Examiner notes that the claimed subject matter differs from that in Vanda, where the claims recited a specific method of treating a patient. The claimed invention does not positively claim any administration of a particular treatment, but rather prescribes/selects a first treatment pathway based on the attention deficit hyperactivity disorder profile (see MPEP 2106.04(d)(2)).
Lastly, Applicant argues that the amended limitation of updating the cognitive state model represents a specific technological improvement to the functioning of a computerized system itself (Remarks, filed 06/09/26, p. 24). Examiner respectfully disagrees. The claimed improvement to the cognitive state model functions to improve the model (i.e., its content or ability to analyze information), as opposed to the functioning of the computerized system itself. The computer system is still performing the same functions (i.e., receiving data, updating parameters, storing information). Further, the Specification does not disclose that the claimed update improves the operation of the computer or another technological system. It is noted that the Court in CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358 (Fed. Cir. 2020), cited by Applicant (Remarks, filed 06/09/26, p. 23), stated that the technical advantages offered by the claimed invention were described in the written description, which was important to the Court’s determination that the claims are drawn to a technological improvement (CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358, 1370-1372 (Fed. Cir. 2020), noting that the Specification explicitly described how the claimed invention of identifying variability in the beat-to-beat timing achieves technological improvements such as detecting the occurrence of atrial fibrillation and atrial flutter as distinct from V-TACH and other arrhythmias). In the instant application, Applicant has not cited to any language in the Specification which would indicate a technical advantage offered by the claimed subject matter.
For these reasons, the rejection under 35 U.S.C. 101 has been maintained, as presented in detail below.
Claim Objections
Claims 21 and 24 are objected to because of the following informalities:
“a second cognitive exercise” recited in claim 21, ln. 2 should likely read “a second cognitive evaluation” or “a second intervention exercise” for clarity purposes, as there is no “first cognitive exercise” in claim 1, from which claim 21 depends;
“the second cognitive exercise” recited in claim 21, ln. 11 and 14 should likely read “the second cognitive evaluation” or “the second intervention exercise”; and
“wherein characterizing user progress in the attention deficit hyperactivity disorder profile comprises” recited in claim 24, ln. 7-8 should likely read “wherein the characterizing user progress in the attention deficit hyperactivity disorder profile comprises” or “wherein characterizing the user progress in the attention deficit hyperactivity disorder profile comprises”.
Appropriate correction is required.
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.
Claim 32 is 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 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. The claim recites “The method of claim 1, further comprising: alerting, based on the cognitive state model, the user that a probability of the user experiencing an adverse cognitive event during a third time period exceeds a threshold probability.” However, the Specification does not disclose providing an alert that a probability of the user experiencing an adverse cognitive event during a third time period exceeds a threshold probability. Rather, the Specification, [0014], recites alerting the user of adverse cognitive events as they occur in real or near-real time. There is no mention of a threshold probability, as claimed. Accordingly, the claim lacks written description.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 7-10, 13-15, 21, and 30-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites in part “characterizing, by the at least one processor, user progress, in the attention deficit hyperactivity disorder profile, based on results of the cognitive exercise, the second timeseries of biosignal data, and the cognitive state model”. There is insufficient antecedent basis for the limitation “the cognitive exercise” in ln. 58 of the claim. Further, it is indefinite if “the cognitive exercise” is intended to refer to the cognitive evaluation or the first intervention exercise.
Claims 7-10, 13-15, 21, and 30-32 are rejected by virtue of their dependencies on claim 1.
Claim 15 recites in part “extracting a first timeseries of galvanic skin response data from the first timeseries of biosignal data”. It is indefinite as to how the first timeseries of galvanic skin response data from the first timeseries of biosignal data differs from the previously recited “first timeseries of skin conductance signals of the user” which, in part, comprises the first timeseries of biosignal data, as recited in claim 1, from which claim 15 depends, and the Specification does not offer further guidance.
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, 13-15, and 21-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1, analyzed as representative claim:
[Step 1] The claim recites in part “A method […]”, which falls within the “process” statutory category of invention.
[Step 2A – Prong 1] The claim recites a series of steps which can be practically performed by one or more humans through mental process (i.e., observation, evaluation, judgment, and/or opinion) (see MPEP 2106.04(a)(2)(III)), certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people – including social activities, teaching, and following rules or instructions) (see MPEP 2106.04(a)(2)(II)), and/or mathematical concepts (i.e., mathematical relationships, mathematical formulas or equations, mathematical calculations) (see MPEP 2106.04(a)(2)(I)). The limitations recited in the body of the claim are analyzed in the Independent Claim 1/Revised Guidance Table below to identify in italics the specific claim limitations found to recite an abstract idea and in bold the additional (non-abstract) claim limitations.
Independent Claim 1
Revised 2019 Guidance
A method of characterizing attention deficit hyperactivity disorder for a user comprising:
A method is a process, which is a statutory subject matter class. See 35 U.S.C. 101.
during a first time period, at a wearable device worn by the user and during performance of a cognitive evaluation by the user prompted by a computer system associated with the user:
A wearable device worn by the user is a generic computing component.
via an electrodermal activity sensor communicatively coupled with the computer system, capturing a first timeseries of skin conductance signals of the user;
Utilizing an electrodermal activity sensor to capture a first timeseries of skin conductance signals of the user encompasses the insignificant extra-solution activity of data gathering. See MPEP 2106.05(g).
via an inertial measurement unit communicatively coupled with the computer system, capturing a first timeseries of motion signals of the user; and
Utilizing an inertial measurement unit to capture a first timeseries of motion signals of the user encompasses the insignificant extra-solution activity of data gathering. See MPEP 2106.05(g).
aggregating, by at least one processor of the computer system, the first timeseries of skin conductance signals and the first timeseries of motion signals into a first timeseries of biosignal data representative of physiological responses during performance of the cognitive evaluation by the user;
Aggregating gathered data encompasses a mental process (including an observation, evaluation, judgment, or opinion).
Alternatively, aggregating gathered data into a first timeseries of biosignal data is directed to the insignificant extra-solution activity of data gathering. See MPEP 2106.05(g).
“At least one processor” is a generic computing component.
at the computer system and following completion of the cognitive evaluation by the user:
A computer system encompasses generic computing components.
accessing, by the at least one processor, a series of results of the cognitive evaluation performed by the user;
Accessing gathered data is insignificant extra-solution activity. See MPEP 2106.05(g).
accessing, by the at least one processor a global model linking results of cognitive evaluations and biosignal data to cognitive states of users diagnosed with attention deficit hyperactivity disorder;
Accessing gathered data is insignificant extra-solution activity. See MPEP 2106.05(g).
generating, by the at least one processor, an attention deficit hyperactivity disorder profile uniquely representing the user based on the series of results of the cognitive evaluation, the first timeseries of biosignal data, and the global model, the attention deficit hyperactivity disorder profile defining: a first confidence score representing a probability of a positive attention deficit hyperactivity disorder diagnosis for the user; a first intensity score representing intensity of attention deficit disorder exhibited by the user; and an attention deficit hyperactivity disorder type exhibited by the user;
Generating an attention deficit hyperactivity disorder profile as claimed defining a first confidence score, first intensity score, and attention deficit hyperactivity disorder type encompasses a mental process(es) (including an observation, evaluation, judgment, and opinion).
in response to the first confidence score exceeding a threshold confidence: selecting, by the at least one processor, a first treatment pathway for the user based on the attention deficit hyperactivity disorder profile and a treatment model linking attention deficit hyperactivity disorder profiles of users diagnosed with attention deficit hyperactivity disorder to treatment pathways; and
Selecting a treatment in response to the analysis/comparison of the gathered/analyzed data encompasses a method of organizing human activity – i.e., managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) and/or mental process (including observation, evaluation, judgment, and opinion).
deriving, by the at least one processor, a cognitive state model for the user, the cognitive state model linking the first timeseries of biosignal data recorded for the user to instances of cognitive states exhibited by the user during performance of the cognitive evaluation;
Deriving a user model linking gathered data to instances of cognitive states exhibited by the user encompasses a mental process (including observation, evaluation, judgment, and opinion).
during a second time period following the first time period, at the wearable device:
The wearable device is a generic computing component.
via the electrodermal activity sensor, capturing a second timeseries of skin conductance signals of the user;
Utilizing the electrodermal activity sensor to capture a second timeseries of skin conductance signals of the user encompasses the insignificant extra-solution activity of data gathering. See MPEP 2106.05(g).
via the inertial measurement unit, capturing a second timeseries of motion signals of the user;
Utilizing the inertial measurement unit to capture a second timeseries of motion signals of the user encompasses the insignificant extra-solution activity of data gathering. See MPEP 2106.05(g).
aggregating, by the at least one processor, the second timeseries of skin conductance signals and the second timeseries of motion signals into a second timeseries of biosignal data representative of physiological responses during performance of the cognitive evaluation by the user;
Aggregating gathered data encompasses a mental process (including an observation, evaluation, judgment, or opinion).
Alternatively, aggregating gathered data into a second timeseries of biosignal data is directed to the insignificant extra-solution activity of data gathering. See MPEP 2106.05(g).
at the computer system:
The computer system encompasses generic computing components.
interpreting, by the at least one processor, and via an application of a trained machine learning or artificial intelligence model, an instance of an adverse cognitive state exhibited by the user based on the second timeseries of biosignal data and the cognitive state model;
Interpreting an instance of an adverse cognitive state based on gathered user data via application of a trained machine learning or artificial intelligence model encompasses a mental process(es) (including an observation, evaluation, judgment, and opinion) and/or mathematical concepts (mathematical relationships) (see MPEP 2106.04(a)(2)(I)).
selecting, by the at least one processor, a first intervention exercise associated with the adverse cognitive state and defined in the first treatment pathway;
Selecting a first intervention exercise encompasses a mental process(es) (including an observation, evaluation, judgment, and opinion).
serving, by the at least one processor, the first intervention exercise to the user; and
Serving the first intervention exercise to the user encompasses a method of organizing human activity – i.e., managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
Alternatively, serving the selected first intervention exercise to a user is directed to the insignificant extra-solution activity of data transmission/display. See MPEP 2106.05(g).
triggering, by the at least one processor, vibration of the wearable device to prompt performance of the first intervention exercise by the user;
Prompting a user to perform the first intervention exercise encompasses a method of organizing human activity – i.e., managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
The at least one processor and the wearable device are generic computer components.
following completion of the first intervention exercise: characterizing, by the at least one processor, user progress, in the attention deficit hyperactivity disorder profile, based on results of the cognitive exercise, the second timeseries of biosignal data, and the cognitive state model; and
Determining/characterizing user progress based on gathered data encompasses a mental process (including observation, evaluation, judgment, and opinion).
in response to the user progress exceeding a threshold progress, confirming, by the at least one processor, selection of the first treatment pathway for the user; and
Confirming, based on user progress, analyzed based on collected data, a selected treatment pathway encompasses a method of organizing human activity – i.e., managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) and/or mental process (including observation, evaluation, judgment, and opinion).
updating, based on the second timeseries of biosignal data and further based on a timestamp of the second timeseries of biosignal data, the cognitive state model to link the characterization of user progress and the second timeseries of biosignal data.
Updating the model based on gathered and observed user data encompasses a mental process (including observation, evaluation, judgment, and opinion).
As noted in the Table above, the claim, as drafted, under a broadest reasonable interpretation, includes methods of organizing human activity, specifically managing personal behavior or interactions between people, mental processes, and/or mathematical concepts, specifically mathematical relationships, but for the recitation of generic computing components. That is, the claim is directed to a method of receiving/accessing gathered data, analyzing said data (i.e., in comparison to prior-gathered data), and assigning a treatment accordingly. This is no different than a physician/therapist/etc. accessing gathered user data (i.e., examination results, sensor data, global model, etc.), mentally analyzing the data to determine a probability and intensity of a positive attention deficit hyperactivity disorder diagnosis for the user and/or user progress, and assigning a treatment plan accordingly. The mere nominal recitations of a generic wearable device, computer system, and at least one processor do not take the claim out of the abstract idea(s) grouping(s). Moreover, the limitation of “interpreting, by the at least one processor, via an application of a trained machine learning or artificial intelligence model, an instance of an adverse cognitive state exhibited by the user based on the second timeseries of biosignal data and the cognitive state model” corresponds to a mental process and/or mathematical concept (mathematical relationship), as noted in the Table above, which thereby falls within the grouping(s) of abstract idea(s). Further, the updating of the user cognitive state model based on additional gathered and observed data encompasses evaluating information and revising the relationships stored in the model. Thus, the claim is directed to an abstract idea(s).
[Step 2A – Prong 2] The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea(s) into a practical application because the additional elements amount to no more than insignificant extra-solution activity and/or the use of generic computer component(s) to perform the abstract idea(s) (i.e., sensors performing their known functions, computer system for storing/receiving data, etc.), as indicated in the Table above. That is, the additional limitations of a wearable device, computer system, at least one processor, and application of a machine learning/artificial intelligence model are recited at a high level of generality such that they do not amount to a particular machine or technical improvement thereof. Rather, the generic manner in which these additional elements are claimed amount to mere instructions to invoke computers as a tool to perform the abstract idea(s) (see MPEP 2106.05(f); see also Berkheimer v. HP, Inc., 881 F.3d 1360, 1366, 125 USPQ2d 1649, 1652-53 (Fed. Cir. 2018) (holding that the claims were directed to mental processes of parsing and comparing data because the steps were recited at a high level of generality and merely used computers as a tool to perform the processes)). Further, as discussed above, the at least one processor and wearable device are recited at a high level of generality, and thus, the limitation of triggering, by the at least one processor, vibration of the wearable device to prompt user performance merely uses the wearable device as a tool to provide a prompt to the user (perform the abstract idea).
There is no indication that the combination of elements improves the functioning of a computer or other technology (see MPEP 2106.05(a)), recites a “particular machine” to apply or use the abstract idea (see MPEP 2106.05(b)), recites a particular transformation of an article to a different thing or state (see MPEP 2106.05(c)), or recites any other meaningful limitation beyond generally linking the judicial exception to a particular technological environment (see MPEP 2106.05(e)).
Accordingly, the claim is directed to the judicial exception.
[Step 2B] Claim 1 does 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(s) into a practical application, the additional elements amount to no more than insignificant extra-solution activity and the use of generic computer components, as noted above. The recitation of the wearable device comprising integrated sensors (electrodermal activity sensor and inertial measurement unit) to collect biosignal data, the computer system for receiving/storing data, and the at least one processor for performing the abstract idea(s) are well-understood, routine and conventional in the field and are recited at a high level of generality such that the limitations do not provide significantly more (i.e., an inventive concept). This may be evidenced by the lack of disclosure in the Specification surrounding the incorporation of the claimed sensors into the wearable device and the usage of the computer system and at least one processor to achieve the claimed functions (see Specification, [0059], which is the only location that mentions a processor and which states that “The computer-executable component can be a processor but any suitable dedicated hardware device can (alternatively or additionally) execute the instructions.”; see also Specification, [0059], “The systems and methods described herein can be embodied and/or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions can be executed by computer-executable components integrated with the application, applet, host, server, network, website, communication service, communication interface, hardware/firmware/software elements of a user computer or mobile device, wristband, smartphone, or any suitable combination thereof.”; see further U.S. Pub. 2018/0070823 A1, [0035]; [0120]; [0123-0137]; [0178-0179], noting that wearable devices incorporating sensors are “well known” and “widely used” to monitor the physical fitness of a user by measuring parameters which may include skin conductance and/or activity/acceleration). Moreover, the machine learning/artificial intelligence model is claimed to be executed on the generic computing equipment. The Specification further indicates that the application of the machine learning/artificial intelligence model is well-understood, routine, conventional, such that the Specification does not need to describe the particulars of the model or its implementation to satisfy enablement (see Specification, [0011]; [0028]; & [0040], which briefly mention the application of machine learning and/or other techniques to perform the routine function of deriving correlations between data).
After considering all claim elements, both individually and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea(s).
Therefore, the claim is not patent eligible.
Independent claims 22 and 27 are rejected for the similar reasoning as claim 1.
Dependent claims 7-10, 13-15, 21, 23-26, and 28-32 recite additional subject matter which further narrows or defines the abstract idea(s) embodied in the independent claims. While the dependent claims may have a narrower scope than the independent claims, no claim contains “significantly more” to transform the corresponding claim into a patent-eligible application of the otherwise ineligible abstract idea(s). For example, claims 7-10, 13-15, 21, 23-26, and 28-32 further recite a mental process (extracting/aggregating gathered timeseries data, linking/correlating and interpreting data and generating biomarkers and a cognitive state model accordingly, estimating intensity scores and confidence scores, interpreting the first confidence score and characterizing a correlation, interpreting disorder types, diagnosis, and cognitive state(s), characterizing user progress, selecting a treatment pathway, generating an ADHD profile, updating the cognitive state model based on additionally gathered data), certain method of organizing human activity (i.e., managing personal behavior or relationships or interactions between people) (generating and transmitting a second prompt, selecting a treatment pathway, obtaining confirmation/rejection of an interpretation of the adverse cognitive state, alerting the user), and/or insignificant extra-solution activity (i.e., data gathering/recording, data transmission) (capturing, accessing, and transmitting data). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, the analysis performed on the independent claims is also applicable on the recited dependent claims, and the dependent claims are not patent eligible.
Conclusion
Applicant's amendment necessitated the new ground(s) 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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/ALYSSA N BIANCAMANO/Examiner, Art Unit 3715
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