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 .
Election/Restrictions
Applicant’s election of claims 1-9 in the reply filed on 2/13/2026 is acknowledged. The election is made as an election without traverse (MPEP § 818.01(a)). Claims 10-22 have been withdrawn from consideration pursuant to 37 CFR 1.142(b).
Status of Claims
The action is in reply to the application filed 2024 March 14.
Claims 1-9 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 07/22/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/244,436 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For claim 6, the prior-filed application does not disclose “the emotional symptom includes a feeling of isolation or a feeling of social phobia, or the physical condition includes a difficulty of sleeping or insomnia.” Examiner cannot find disclosure of the emotional symptom including a feeling of isolation or a feeling of social phobia, or the physical condition includes a difficulty of sleeping or insomnia. For claim 7, the prior-filed application does not disclose “wherein the prediction of the symptomatic score comprises a percentage prediction for a predicted diagnostic condition.” Examiner cannot find disclosure of the prediction of the symptomatic score comprising a percentage prediction for a predicted diagnostic condition. Accordingly, claims 6-7 are not entitled to the benefit of the prior 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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process (claims 1-9).
INDEPENDENT CLAIMS
Step 2A Prong 1
Claim 1 recites steps of
obtaining textual data from a patient;
analyzing the textual data via an algorithm to generate predictive contents, wherein the predictive contents comprise a prediction of a diagnostic condition, a prediction of a symptomatic score, and a prediction of a compliance level of the patient;
predicting a mental status of the patient in accordance with the predictive contents; and
providing a modality of mental health treatment based on the predicted mental status of the patient.
These steps for automating delivery mental health care, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. That is, nothing in the claim element precludes the italicized portions from managing personal behavior or relationships or interactions between people through organizing the activity around predicting an individual's mental status and providing a modality of mental health treatment based on the predicted mental status. This could be analogized to considering historical usage information while inputting data. If a claim limitation, under its broadest reasonable interpretation, covers performance as organizing human activity but for the recitation of generic computer components, then it falls within the “Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application. In particular, the additional elements non-italicized portions identified above for claim 1, does 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 via an algorithm amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of obtaining textual data from a patient amounts to mere data gathering since it does not add meaningful limitation to the obtaining action performed, see MPEP 2106.05(g))
Each of the above additional elements therefore only amounts to mere instructions to implement functions within the abstract idea using generic computer components or other machines within their ordinary capacity; and, add insignificant extra-solution activity to the abstract idea. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. These elements are therefore not sufficient to integrate the abstract idea into a practical application. Therefore, the above claims, as a whole, are directed to an abstract idea.
Step 2B
The claim(s) 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, and add insignificant extra-solution activity to the abstract idea. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to mere instructions to apply an exception in particular fields such as recitation of via an algorithm, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f).
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as recitation of obtaining textual data from a patient, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i).
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 generic computer implementation.
DEPENDENT CLAIMS
Step 2A Prong 1
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-9 reciting particular aspects for automating delivery mental health care such as
[Claim 2] wherein providing the modality of mental health treatment further comprises taking into consideration a score related to a set of quantitative measurements designed for mental health therapy;
[Claim 3] wherein the set of quantitative measurements comprises Patient Health Questionnaire-9 (PHQ-9) questions designed for depression, General Anxiety Disorder-7 (GAD-7) questions for generalized anxiety, or Quality of Life Enjoyment and Satisfaction Questionnaire-18 (Q-LES) questions for quality of life;
[Claim 4] wherein the modality of the mental health treatment is determined based on the predicted mental status of the patient and the score from one of PHQ-7, GAD-7, or Q-LES;
[Claim 5] wherein the prediction of the diagnostic condition comprises a prediction of a physical symptom, an emotional symptom or a physical condition;
[Claim 6] wherein the physical symptom includes panic attack or anxiety, the emotional symptom includes a feeling of isolation or a feeling of social phobia, or the physical condition includes a difficulty of sleeping or insomnia;
[Claim 7] wherein the prediction of the symptomatic score comprises a percentage prediction for a predicted diagnostic condition;
[Claim 8] wherein the compliance level of the patient is a propensity or a likelihood that the patient stays within a therapy program;
[Claim 9] wherein the algorithm comprises a natural language processing algorithm trained to evaluate a relationship of a textual statement in accordance with a five-part model of cognitive behavioral therapy that recognizes situation (positive or negative), behavior, thought (positive or negative), emotion (positive or negative), and physical reaction;
these italicized portions are methods of organizing human activity since they merely describe types of data and determinations that can be performed by humans.
Step 2A Prong 2
Dependent claim 9 recites additional subject matter which amount to limitations consistent with the additional elements in the independent claims (the additional limitations in claim 9 (wherein the algorithm comprises a natural language processing algorithm trained to evaluate a relationship of a textual statement) amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
Dependent claim 9 recites 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, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f). Also, see [078] which discloses off-the-shelf display and input devices, [0081] which discloses off-the-shelf memory types, and [0084] which discloses off-the-shelf processors. There is no indication that these additional elements improve the functioning of a computer or improves any other technology. Their collective functions merely provide generic computer implementation. Therefore, in consideration of all the facts, the present invention is not a patent-eligible invention under USC 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5-6, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cummins et al. (US20210202065A1).
Regarding claim 1, Cummins discloses obtaining textual data from a patient ([0011] “receiving text data relating to a therapy session between a therapist and a patient”)
analyzing the textual data via an algorithm to generate predictive contents ([0142] “The text data 16 is divided 116 into utterances 118.” [0168] “When assigning a meaning to (classifying) a particular utterance, the HiBiLSTM model has access to the information from all utterances in the transcript in the correct positions.” [0175] “Referring again to FIG. 3, at a fourth step S4, a second part of the model (second part of the HiBiLSTM therapy insights model) is used to make a prediction about the patient, the therapist and/or the therapy process.”)
wherein the predictive contents comprise a prediction of a diagnostic condition, a prediction of a symptomatic score, and a prediction of a compliance level of the patient ([0053] “providing a prediction of the presence of a mental health disorder in the patient” [0265] “According to IAPT, a patient scoring 8 or more in the GAD-7 (range 0-21)” [0038] “a likelihood of engagement by the patient”)
predicting a mental status of the patient in accordance with the predictive contents ([0218] “The medical diagnosis comprises providing a prediction of the presence of a mental health disorder in the one or more patient”)
and providing a modality of mental health treatment based on the predicted mental status of the patient ([0218] “Additional further actions may be taken by the system subsequent to provision of the medical diagnosis, such as recommendation of a particular therapy protocol to the therapist.”)
Regarding claim 5, Cummins discloses wherein the prediction of the diagnostic condition comprises a prediction of a physical symptom, an emotional symptom or a physical condition ([0034]-[0037] “In some embodiments, the output prediction or output predictions of the method may comprise: a likelihood of the patient having a particular mental health disorder” [0081] “the mental health disorder may comprise for example depression, an anxiety disorder, PTSD, an eating disorder, a sleep disorder or sexual dysfunction.”)
Regarding claim 6, Cummins discloses wherein the physical symptom includes panic attack or anxiety, the emotional symptom includes a feeling of isolation or a feeling of social phobia, or the physical condition includes a difficulty of sleeping or insomnia ([0058] “the mental health disorder may be […] panic disorder (episodic paroxysmal anxiety) […] a sleep disorder, social phobias”)
Regarding claim 8, Cummins discloses wherein the compliance level of the patient is a propensity or a likelihood that the patient stays within a therapy program ([0338] “predict patient engagement (defined as the likelihood a patient will return for a second therapy session)”)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35
U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Cummins et al. (US20210202065A1) in view of Blake et al. (US20150112694A1).
Regarding claim 2, Cummins does not explicitly disclose however Kaput teaches wherein providing the modality of mental health treatment further comprises taking into consideration a score related to a set of quantitative measurements designed for mental health therapy ([0038] “The present invention is directed to the field of behavioral health assessment systems, specifically, a user friendly computer assisted behavioral health assessment systems using proprietary algorithms to interpret and score user generated input to produce a substantially real-time preliminary evaluation of a subject's behavioral health vital signs including recommendations for treatment”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Cummins taking into consideration a score related to a set of quantitative measurements designed for mental health therapy as taught by Blake since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
Regarding claim 3, Cummins discloses wherein the set of quantitative measurements comprises Patient Health Questionnaire-9 (PHQ-9) questions designed for depression, General Anxiety Disorder-7 (GAD-7) questions for generalized anxiety, or Quality of Life Enjoyment and Satisfaction Questionnaire-18 (Q-LES) questions for quality of life ([0179] “Clinical improvement as used herein is defined as a patient achieving a statistically significant decrease in symptom severity, as measured on the PHQ-9 and GAD-7 scales.”)
Regarding claim 4, Cummins discloses wherein the modality of the mental health treatment is determined based on the predicted mental status of the patient and the score from one of PHQ-7, GAD-7, or Q-LES ([0265] “Reliable improvement was calculated based on two severity measures: PHQ-9 and GAD-7, corresponding to depressive and anxiety symptoms respectively. Both measures were completed by the patient at initial assessment and before every therapy session.”)
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wolf et al. (US20240055088A1) in view of Krasik et al. (US20170372023A1).
Regarding claim 7, Cummins does not explicitly disclose however Krasik teaches wherein the prediction of the symptomatic score comprises a percentage prediction for a predicted diagnostic condition ([0067] “the value represents a percent probability of the patient being in the disease or non-disease state.”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Cummins a percentage prediction for a predicted diagnostic condition as taught by Krasik since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wolf et al. (US20240055088A1) in view of Dolan et al. (US20220068463A1) and further in view of Hudson et al. (Improving Distress in Dialysis (iDiD): A tailored CBT self‐management treatment for patients undergoing dialysis).
Regarding claim 9, Cummins does not explicitly disclose however Dolan teaches wherein the algorithm comprises a natural language processing algorithm trained to evaluate a relationship of a textual statement ([0042] “The natural language processing (NLP) engine 143 includes logic to detect the intent of the patient from their utterances and allows the patient to digress from the linearly structured steps of the CBT session.”)
It would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Cummins a natural language processing algorithm trained to evaluate a relationship of a textual statement as taught by Dolan since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
Cummins in view of Dolan does not explicitly disclose however Hudson teaches in accordance with a five-part model of cognitive behavioral therapy that recognizes situation (positive or negative), behavior, thought (positive or negative), emotion (positive or negative), and physical reaction ([0042] “The natural language processing (NLP) engine 143 includes logic to detect the intent of the patient from their utterances and allows the patient to digress from the linearly structured steps of the CBT session.”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Cummins and Dolan a five-part model of cognitive behavioral therapy that recognizes situation (positive or negative), behavior, thought (positive or negative), emotion (positive or negative), and physical reaction as taught by Hudson since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
Prior Art Cited but Not Relied Upon
Furukawa, T. A., Iwata, S., Horikoshi, M., Sakata, M., Toyomoto, R., Luo, Y., ... & Aramaki, E. (2023). Harnessing AI to optimize thought records and facilitate cognitive restructuring in smartphone CBT: An exploratory study. Cognitive Therapy and Research, 47(6), 887-893.
This reference is relevant because it discloses using AI to automate mental health treatment.
Conclusion
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/WINSTON R FURTADO/Examiner, Art Unit 3687