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 .
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.
Claim(s) 1,3,5,8-14,17-18 and 20-21 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Claim 1 recites:
A system for predicting a future change in a mental health state of a user and for administering therapeutic digital content accordingly, the system comprising:
one or more processors of a smart device of the user; and
a memory storing instructions that, when executed by the one or more processors, cause the system to:
monitor, via one or more sensors of the smart device of the user user's smart devices, a plurality of parameters of the user, wherein the plurality of parameters includes at least one of physiological data of the user or data indicative of the mental health state of the user;
extract features from the plurality of parameters;
determine feature changes over time;
predict the future change in the mental health state of the user based on the features and based on the feature changes over time;
classify the future change in the mental health state of the user into (i) a step- up classification, (ii) a step-down classification, or (iii) a no change classification;
responsive to the step-up classification, output the therapeutic digital content comprising cognitive behavioral therapy;
responsive to the step-down classification, output the therapeutic digital content comprising a wellness application; and
responsive to the no change classification, output the therapeutic digital content comprising a previously selected therapeutic digital content.
Step 1:
The claim as a whole falls within at least one statutory category, i.e. a process, machine, manufacture, or composition of matter.
Step 2A Prong One:
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Certain methods of organizing human activity” because the steps of extracting data to detect a change in mental state and generating contents to communicate to a person has been traditionally performed by a physician when treating a patient, i.e. managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). MPEP § 2106.04(a)(2)(II)
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Mental processes”.
But for a generic computer recited with a high level of generality in a post hoc manner to implement the abstract idea, the identified steps may be practically performed in the human mind either mentally or with pen and paper.
Accordingly, these limitations have been found to be directed towards concepts performed in the human mind (including an observation, evaluation, judgment, opinion). MPEP 2106.04(a)(2)(III)
The different categories of abstract ideas are being considered together as one single abstract idea. MPEP 2106.04(II)(B)
Dependent claim(s) recite(s) additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim(s) 3, 5, 8-11 reciting limitations further defining the abstract idea, which may be performed in the mind but for recitation of generic computer components, and/or may be a method of managing relationship or interactions between people).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites the following additional element(s), if any:
one or more processors of a smart device of the user; and
a memory storing instructions that, when executed by the one or more processors, cause the system to:
monitor, via one or more sensors of the smart device of the user user's smart devices, a plurality of parameters of the user;
output the therapeutic digital content comprising cognitive behavioral therapy;
output the therapeutic digital content comprising a wellness application; and
output the therapeutic digital content comprising a previously selected therapeutic digital content.
The additional element(s) do(es) not integrate the abstract idea into a practical application, other than the abstract idea per se.
Regarding the processor and memory, when read in light of the Specification as originally filed by one of ordinary skill in the art, the broadest reasonable interpretation of these limitations would include a generic computer and associated generic components.
These limitations amount to mere instructions to apply an exception (e.g. invoking computers as a tool to perform the abstract idea). MPEP 2106.05(f))
Regarding the user’s smart devices, the Specification as originally filed on 05 October 2021 discloses a smart phone (page 11 paragraph 0030), as well as a gyrometer, a camera, etc. (page 27 paragraph 0096). Accordingly, this limitation merely adds insignificant extra-solution activity to the abstract idea (such as mere data collection). MPEP 2106.05(g)
Regarding the step of selectively outputting various forms of contents, this limitation merely adds insignificant extra-solution activity to the abstract idea (such as mere data display). MPEP 2106.05(g)
Dependent claim(s) recite(s) additional subject matter which amount to limitation(s) consistent with the additional element(s) in the independent claims (such as claim(s) 3 reciting electronic recordkeeping of patient records, additional limitation(s) which add(s) insignificant extra-solution activity to the abstract idea by selecting a particular data source or type of data to be manipulated, claim 5 reciting a sensor, additional limitation(s) which add(s) insignificant extra-solution activity to the abstract idea which amounts to mere data gathering, claim 9 reciting a smartphone, additional limitation(s) which amount(s) to invoking computers as a tool to perform the abstract idea, claims 10-11 reciting outputting an alert to a device, additional limitation(s) which add(s) insignificant extra-solution activity to the abstract idea).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, the additional elements do not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Accordingly, the claim recites an abstract idea.
Step 2B:
The claim 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 into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use.
The additional elements of, as discussed above and incorporated herein, amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use, as discussed above and incorporated herein.
Mere instructions to apply an exception, insignificant extra-solution activity, and linking to a particular technological environment using a generic computer component cannot provide an inventive concept.
Regarding the smart devices, Madan (20140052475) discloses gyroscope and accelerometer of a mobile device (page 5 paragraph 0038) of a smartphone (page 5 paragraph 0039), and amount(s) to element(s) that have been recognized as well-understood, routine, and conventional (WURC) activity in particular fields.
Regarding the cognitive behavioral therapy and wellness app, Clark (20190189259) discloses cognitive behavioral therapy (page 19 paragraph 0461) and a wellness App (page 17 paragraph 0355) in a manner that would amount(s) to element(s) that have been recognized as WURC activity in particular fields.
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claim(s) 3 reciting electronic patient records; e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii); claim 5 reciting a patient sensor, Hong (20160259908) discloses body sensors as being WURC in the pertinent arts (page 3 paragraph 0041); claims 10, 11 reciting outputting an alert to a device, Hong discloses determining the mental state of a patient and generating requests for emergency services in a manner that would be WURC in the pertinent arts (Figure 8 label 803, paragraph 0159)).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
The claim is not patent eligible.
Claim(s) 12-14, 17-18, 20-21 recite(s) substantially similar limitations as those of claim(s) 1, 3, 5, 8-11 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1, 3, 5, 8-14, 17-18, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over DiLorenzo (20020177882) in view of Dilorenzo (20070150025, hereafter referred to as “Dilorenzo ‘025”) and Madan.
Claim 1: DiLorenzo discloses:
A system (Abstract illustrating a system) for predicting a future change in a mental health state of a user (page 14 paragraph 0135 illustrating predicting a future trends and rates of change of patient parameters) and for administering therapeutic digital content accordingly (page 20-21 paragraph 0190 illustrating automatically adjusting the treatment parameters [considered to be a form of “therapeutic digital content”]), the system comprising:
one or more processors of
a memory storing instructions (Figure 3 illustrating a computer memory) that, when executed by the one or more processors, cause the system to:
monitor,
extract features from the plurality of parameters (page 9 paragraph 0090 illustrating extracting relevant information [considered to be a form of “features”] from the sensed data);
determine feature changes over time (page 14 paragraph 0135 illustrating calculating the rate of change, including trends and rates of change, in spike parameters [considered to be a form of “feature changes”] over a period of time);
predict the future change in the mental health state of the user based on the features and based on the feature changes over time (page 14 paragraph 0135 illustrating determining the future behavior including trends and rates of change in the future);
classify the future change in the mental health state of the user into (i) a step- up classification (page 21 paragraph 0195 illustrating determining that the treatment is an undertreatment based on the predicted future trend of the patient), (ii) a step-down classification (page, or (iii) a no change classification;
responsive to the step-up classification, output the therapeutic digital content comprising cognitive behavioral therapy (page 21 paragraph 0195 illustrating adjusting the treatment magnitude up);
responsive to the step-down classification, output the therapeutic digital content (page 21 paragraph 0195 illustrating adjusting the treatment magnitude down)
responsive to the no change classification, output the therapeutic digital content comprising a previously selected therapeutic digital content (page 21 paragraph 0195 illustrating maintaining the current treatment magnitude).
DiLorenzo does not disclose:
a smart device;
one or more sensors of the smart device;
a wellness application.
Dilorenzo ‘025 discloses:
a wellness application (page 18 paragraph 0156 illustrating providing treatment regimen including behavioral modifications).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to include the behavioral modification treatment of Dilorenzo ‘025 within the patient treatment system of DiLorenzo with the motivation of improving patient care by providing efficacious treatments to patients who may not need pharmacological treatments (Dilorenzo ‘025; page 18 paragraph 0156).
DiLorenzo in view of Dilorenzo ‘025 do not disclose:
a smart device;
one or more sensors of the smart device.
Madan discloses:
a smart device (page 5 paragraph 0039 illustrating a mobile device in the form of a smartphone);
one or more sensors of the smart device (page 5 paragraph 0038 illustrating a plurality of sensors of a mobile device, e.g. accelerometer, gyroscope).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to include the smart sensors of Madan within the patient treatment system of DiLorenzo in view of Dilorenzo ‘025 with the motivation of improving patient care by providing remote sensor data in a convenient manner that could help detect early symptoms of a seizure for a patient (Madan; page 1 paragraph 0017).
Claim 3: DiLorenzo in view of Dilorenzo ‘025 and Madan disclose:
The system of claim 1, as discussed above and incorporated herein.
DiLorenzo further discloses:
wherein the plurality of parameters further includes at least one of: physiological data of the user (page 2 paragraph 0018 illustrating physiological data), data derived from contextual input from the user such as ecological momentary assessment data (this limitation is rendered optional by the limitation “selected from the group consisting of” and therefore need not be taught by the applied art), data from electronic health records (page 9 paragraph 0095 illustrating historical patient data), or data reflecting behavior of the user (page 2-3 paragraph 0021 illustrating monitoring the patient’s tremors [considered to be a form of “behavior”]).
Claim 5: DiLorenzo in view of Dilorenzo ‘025 and Madan disclose:
The system of claim 1, as discussed above and incorporated herein.
DiLorenzo further discloses:
further comprising instructions that, when executed by the one or more processors, cause the system to:
receive data indicative of a conscious mental health state of the user (page 23 paragraph 0273 illustrating receiving input from the patient [considered to be a form of “conscious mental health state”]); and
monitor physiological parameters indicative of a subconscious mental health state of the user using a sensor (Figure 1 label 27, page 5 paragraph 0058 illustrating a sensor used to measure patient data [considered to be a form of “subconscious mental health state”]) of the one or more sensors (as discussed above, and incorporated herein),
wherein extracting the features from the plurality of parameters further comprises extracting the features from the data indicative of the conscious mental health state and the physiological parameters (page 10 paragraph 107 illustrating identifying features that are representative of the subject).
Claim 8: DiLorenzo in view of Dilorenzo ‘025 and Madan disclose:
The system of claim 1, as discussed above and incorporated herein.
DiLorenzo further discloses:
wherein predicting the future change in the mental health state of the user occurs at a predetermined time interval (page 23 paragraph 0273 illustrating a daily time interval).
Claim 9: DiLorenzo in view of Dilorenzo ‘025 and Madan disclose:
The system of claim 1, as discussed above and incorporated herein.
DiLorenzo in view of Dilorenzo ‘025 do not disclose:
wherein the smart device includes a smartphone.
Madan discloses
wherein the smart device includes a smartphone (page 5 paragraph 0039 illustrating a smartphone).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to include the smartphone of Madan within the patient treatment system of DiLorenzo in view of Dilorenzo ‘025 and Madan with the motivation of improving patient care by providing remote sensor data in a convenient manner that could help detect early symptoms of a seizure for a patient (Madan; page 1 paragraph 0017).
Claim 10: DiLorenzo in view of Dilorenzo ‘025 and Madan disclose:
The system of claim 1, as discussed above and incorporated herein.
DiLorenzo further discloses:
further comprising instructions that, when executed by the one or more processors, cause the system to:
responsive to the step-up classification, output an alert via a device separate from the system if the step-up classification has a severity above a predefined severity threshold (page 20-21 paragraph 0190 illustrating notifying a physician when the electrodes require impending replacement).
Claim 11: DiLorenzo in view of Dilorenzo ‘025 and Madan disclose:
The system of claim 1, as discussed above and incorporated herein.
DiLorenzo does not disclose:
further comprising instructions that, when executed by the one or more processors, cause the system to:
responsive to the no change classification, output an alert via a device separate from the system if the no change classification has remained for a predetermined time interval.
Dilorenzo ‘025 discloses
responsive to the no change classification (page 14 paragraph 0123 illustrating prescribing a maximum amount of pharmacological agent [considered to be a form of “no change classification”, see discussion of claim 1 above regarding outputting previous treatment for no change in classification), output an alert via a device separate from the system if the no change classification has remained for a predetermined time interval (page 14 paragraph 0123 illustrating notifying a physician after a time period).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to include the physician notification of DiLorenzo ‘025 within the patient treatment system of DiLorenzo in view of DiLorenzo ‘025 and Madan with the motivation of providing improved patient care by notifying physicians of patients who are not improving and would need intervention (Dilorenzo ‘025; page 14 paragraph 0123).
Claim(s) 12, 13, 14, 17, 18, 20, 21 recite(s) substantially similar limitations as those of claim(s) 1, 9, 3, 5, 5, 8, 10 above, respectively, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Response to Arguments
In the Remarks filed on 09 April 2026, Applicant makes numerous arguments. Examiner will address these arguments in the order presented.
On page 6-7 Applicant argues that the applied do not disclose that the monitoring unit and other units are present in one single device.
The argued limitation recites “one or more sensors of the smart device” is used to monitor “physiological data of the user” and/or “data indicative of the mental health state of the user”.
As discussed in the section above, the argued data is broad and may encompass many different types of data. The data is fully found in the applied art, as discussed above and incorporated herein.
Regard the units being present in a single device, the argued limitation recites sensors “of” the smart device. The limitation “of” does not positively recite how the sensors are integrated into the smart device. Instead, the term “of” may refer to sensors that are not bodily incorporated into the smart device, but may instead refer to ownership or assignment of particular sensors as being operatively connected to the smartphone in any manner, including wireless sensors or sensors whose data are provided to the smartphone.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., bodily/structural integration of the sensors into the smartphone as a single unit) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
On page 8-11 Applicant argues that the integration of the sensors into a single smartphone provides technical improvement.
As discussed above and incorporated herein, the limitation does not positively recite the structural integration of the sensors into the smartphone, but instead merely places a broad functional relationship between the sensors and the smartphone, i.e. the sensors “of” the smartphone.
This type of mere existing and known types of devices provide no technical improvement because they are used to merely collect and process data, as is well known in the art. There is no improvement to any of the devices because they would operate in the manner that is known in the art.
As can be seen, the claims do not positively recite how the sensors are integrated into the smartphone as to provide any technical improvement.
Based on the evidence presented above, Applicant’s arguments are not found persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fors (20080208630) discloses processing patient data to generate a patient context (Abstract) in a manner similar to those disclosed in the instant pending Specification as originally filed.
Dhumne (20110118555) discloses monitoring patient’s physio-psychological conditions (Abstract) in a manner similar to those disclosed in the instant pending Specification as originally filed.
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 extension fee 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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/T.N.N./ Examiner, Art Unit 3685
/KAMBIZ ABDI/ Supervisory Patent Examiner, Art Unit 3685
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