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 .
Applicant’s submission of a Response
Applicant’s submission of a response was received on 08/06/2026. Presently, claims 1, 6, 10, 15, and 20-34 are pending.
Response to Arguments
Applicant's arguments filed 08/06/2026 have been fully considered but they are not persuasive. Claims have overcome each and every objection and 112(b) rejection previously set forth in the Office Action mailed 03/06/2026. Applicant’s representative asserts that the amended claims limitations are not met. However, the rejection of claims 1, 6, 10, 15, and 20-34 is maintained as presented below. Moreover, in light of the amendments to the claims, new rejection(s) under 35 U.S.C. 112(a) have been presented, as discussed in detail below.
In regards to rejections under 35 U.S.C. §101, applicant asserts the following: “Amended claim 1 expressly recites a method for treatment of ADHD. It does not merely identify, diagnose, or report a behavioral state. It affirmatively causes a wearable device to deliver a reinforcement-based behavioral intervention under a defined sensor- derived condition and then modifies the parameter governing a later intervention based on subsequently measured behavioral data.” (Page 14 of Remarks)
Regarding point (1), the examiner respectfully disagrees.
In response to the arguments above, affirmatively delivering a reinforcement-based behavioral intervention and then modifying the parameter governing a later intervention based on subsequently measured behavioral data is a process that can be performed in the mind. Applicant is simply using a sensor for this process. However, as pointed out below, delivering a reinforcement-based behavioral intervention and then modifying the parameter governing a later intervention based on subsequently measured behavioral data is part of the abstract idea. Merely because applicant has introduced sensors to perform the function rather than the human mind does not now make the claim patent eligible. Such was the very basis for the Supreme Court's decision in Alice. As such, this argument can also not be found convincing here. (See 101 rejection below).
In regards to rejections under 35 U.S.C. §103, applicant asserts the following: “MPEP § 2106.04(d)(2) recognizes that an alleged judicial exception is integrated into a practical application when it is affirmatively used to effect a particular treatment for a disease or medical condition. The identified examples are not limited to pharmaceutical administration and expressly include non-pharmacological treatments such as physiotherapy, phototherapy, and "the like." The controlling requirement is that the claim affirmatively recite an action effecting the particular treatment. Claim 1 satisfies that requirement through the state-contingent, wearable-delivered behavioral intervention.” (Page 15 of Remarks).
Regarding point (2), the examiner respectfully disagrees.
In response to the arguments above, even applicant is aware that this intervention is not identical to the one being claimed. Administrating a pharmaceutical drug is not the same as providing feedback or intervention. (See 101 Rejection below)
In regards to rejections under 35 U.S.C. §101, applicant asserts the following: “The sensor data are not collected merely for display, reporting, recommendation, or human consideration. The claimed calculations are used to govern whether and under what sensor-derived condition the wearable system delivers a reinforcement output. That output is not the endpoint of the claim. Following the output, the system obtains additional sensor-derived behavioral data after a defined period, determines a second percentage change from baseline, and modifies the deviation threshold governing presentation of the reinforcement output during a later cycle.” (Page 16 of Remarks)
Regarding point (3), the examiner respectfully disagrees.
In response to the arguments above, determining a second percentage change from baseline, and modifying the deviation threshold governing presentation of the reinforcement output during a later cycle a is a process that can be performed in the mind. Applicant is simply using a sensor for this process. However, as pointed out below, determining a second percentage change from baseline, and modifying the deviation threshold governing presentation of the reinforcement output during a later cycle is part of the abstract idea. Merely because applicant has introduced sensors to perform the function rather than the human mind does not now make the claim patent eligible. Such was the very basis for the Supreme Court's decision in Alice. As such, this argument can also not be found convincing here. (See 101 rejection below).
In regards to rejections under 35 U.S.C. §101, applicant asserts the following: “The claimed improvement is therefore not merely ‘better behavior’ or ‘improved treatment.’ It concerns how the wearable system itself determines and controls later intervention delivery. The response-dependent threshold update allows the system to alter future operation based on the measured behavioral state observed during the treatment process rather than repeatedly applying a static threshold.” (Page 18 of Remarks)
Regarding point (4), the examiner respectfully disagrees.
In response to the arguments above, determining and controlling later intervention delivery can be performed in the mind. Applicant is simply using a sensor for this process. However, as pointed out below, determining and controlling later intervention delivery is part of the abstract idea. Merely because applicant has introduced sensors to perform the function rather than the human mind does not now make the claim patent eligible. Such was the very basis for the Supreme Court's decision in Alice. As such, this argument can also not be found convincing here. If there is an improvement to the technology being used, then applicant should disclose it. (See 101 rejection below).
In regards to rejections under 35 U.S.C. §101, applicant asserts the following: “The Federal Circuit has recognized that a claim directed to a specific technique that changes the operation of a monitoring system may be eligible even though it employs otherwise known hardware and data-processing components. See CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358, 1368-71 (Fed. Cir. 2020). Likewise, current USPTO guidance confirms that logical structures and processes may constitute technological improvements where the specification describes the improvement and the claim reflects the operative steps that provide it. See MPEP §§ 2106.04(d)(1), 2106.05(a); Ex parte Desjardins, Appeal No. 2024-000567 (Appeals Review Panel Sept. 26, 2025) (precedential). The specification describes the relevant technical problem and adaptive solution at paragraph [0072]: Determine based on pre - set parameters at what level of change the rewards will be generated and presented to the child. The algorithm adapts to the child's performance in order to deliver an appropriate challenge ( not too difficult or too easy ) and foster progress ( i.e. behavioral shaping = initially reinforce small changes in behavior and later making it gradually more difficult for the child to earn rewards ). For instance , at the start of treatment the reward could be set to be generated for a 10 % change ( decrease ) in hyperactivity level along the specific metrics . However, if after a set period ( e.g. 24 hrs .; specific duration to be determined during proof - of - concept studies ) there is only a maximum 6 % change in hyperactivity the algorithm will adapt and generate rewards for 6 %. Subsequently after a set period ( e.g. 48 hrs . ) of the child consistently achieving 6 % change in hyperactivity, the algorithm will start generating rewards for a higher % change ( e.g. 7 % ) in order to increase the level of challenge and foster progress.” (Page 19 of Remarks)
Regarding point (5), the examiner respectfully disagrees.
In response to the arguments above, the improvement the applicant is quoting is an improvement to the abstract idea itself, which is also an improvement that can be performed in the mind. That is, these items could all still be done via people talking to each other and that is where the improvement lies rather than improving the sensors themselves or providing a practical application of the abstract idea. (See 101 rejection below).
In regards to rejections under 35 U.S.C. §101, applicant asserts the following: “The Office identifies defining behaviors, defining parameters, determining baseline compliance, and determining deviations as concepts capable of performance in the human mind. Even assuming certain preliminary defining or evaluative limitations could be characterized in that manner, the Office may not treat the claim's sensor and adaptive- control limitations as mental processes.” (Page 22 of Remarks)
Regarding point (6), the examiner respectfully disagrees.
In response to the arguments above, the office is not treating the claim’s sensor as an abstract idea. The office is treating “defining parameters, determining baseline compliance, and determining deviations” as concepts capable of being performed in the human mind. Merely because applicant has introduced sensors to perform the function rather than the human mind does not now make the claim patent eligible. Such was the very basis for the Supreme Court's decision in Alice. As such, this argument can also not be found convincing here. (See 101 rejection below).
In regards to rejections under 35 U.S.C. §103, applicant asserts the following: “The office action states that claims 1, 3-6, and 12-15 are rejected in view of the combination of Revibe and Zhou. First, the Cited References Do Not Disclose the Claimed Treatment-Control Relationship. The rejection characterizes the claims at an unduly generalized level as collecting wearable data, analyzing user performance, and providing feedback or rewards. That characterization omits the operative relationships required by the claims, as amended.” (Page 22 of Remarks)
Regarding point (7), the examiner respectfully agrees.
In response to the arguments above, arguments have been found convincing in regards to the newly amended limitations. In regards to rejections under 35 U.S.C. §103, the rejection is withdrawn.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are directed to at least one of abstract idea groupings, according to the 2019 Revised Patent Subject Matter Guidelines (Mathematical Concepts, Mental Processes and/or Certain Methods of Organizing Human Activity). Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as discussed below.
Step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance
More specifically, regarding Step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, the claims are directed to a system and/or process, which is are statutory categories of invention.
Step 2A-1 of the 2019 Revised Patent Subject Matter Eligibility Guidance
Next, the claims are analyzed to determine whether it is directed to a judicial exception.
Independent claim 1 recites the following, with the abstract ideas highlighted in bold, including an indication as to the abstract idea grouping(s) to which the indicated limitations belong to, according to the 2019 Revised Patent Subject Matter Guidelines. Independent claims 10, having substantially similar features, were also analyzed and to which the following conclusion is also applicable:
A method for the treatment of ADHD, comprising steps of: providing a wearable device, said wearable device being connectable to an electronic device having an app thereon; receiving treatment targets via the app, said treatment targets including a plurality of motion based behaviors; receiving sensor data and location data via sensors in the wearable device; analyzing the sensor data in the electronic device by an algorithm, comprising steps of: calculating a baseline level for a plurality of motion based behaviors based on specific metrics; determining deviations from a baseline level for a plurality of motion based behaviors; calculating a first percentage change of deviation from the baseline for a plurality of motion based behaviors; comparing the deviations to pre-set parameters; said pre-set parameters comprising a positive reinforcement-generation condition; delivering a reinforcement output to a user for a first percentage of change of deviation from a baseline level for a plurality of motion based behaviors; the positive reinforcement output constituting a therapeutic intervention; measuring after a set period of time following the positive reinforcement output a second percentage of change of deviation from a baseline level for a plurality of motion based behaviors; such percentage characterizing the user's behavioral response to the delivered intervention, and updating the positive reinforcement- generation condition as a function of a second percentage of change of deviation; said positive reinforcement-generation condition being adjusted in a direction that increases or decreases the difficulty of satisfying a reinforcement condition based on the user's measured response to the intervention delivered during the preceding monitoring period reflecting improvement or regression; and whereby the intervention delivered in each later period is continuously adapted based on a percentage change of deviation from a baseline level for a plurality of motion based behaviors, such percentage change being the user's measured response to the intervention delivered in a preceding monitoring period.
The limitations in claim 1 (as well as claim 10) recites an abstract idea included in the groupings of mental processes and certain methods of organizing human activity, connected to technology only through application thereof using generic computing elements (e.g., electronic device, etc.) and/or insignificant extra-solution activity. According to the 2019 Revised Patent Subject Matter Guidelines:
Mental Processes include concepts performed in the human mind (including an observation, evaluation, judgement, opinion);
Certain Methods of Organizing Human Activity include:
1. Fundamental Economic Principles or Practices (including hedging (i.e., wagering), insurance, mitigating risk);
2. Commercial or Legal Interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations);
3. Managing Personal Behavior or Relationships or Interactions Between People (e.g. social activities, teaching, and following rules or instructions). The interaction encompasses both activity of a single person (for example a person following a set of instructions) and activity that involves multiple people (such as a commercial or legal interaction). Thus, some interactions between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within this grouping;
Specifically, the instant claims include functions/limitations, as highlighted in the independent claim above, that constitute at least:
C. Following rules and/or instructions, such as including the functions related to the playing of a game, which is an abstract idea included in the grouping of Managing Personal Behavior or Relationships or Interactions Between People. These sets of rules are interpreted as at least certain methods of organized human activity insomuch as the claim limitations are directed to performing or following the set of rules or instructions concerning a game while only generically connected to interaction with a computer utilizing non-special purpose generic computing elements and/or insignificant extra-solution activity, as set forth in the claims.
D. Concepts performed in the human mind (e.g., “calculating a baseline level for a plurality of motion based behaviors based on specific metrics, determining deviations from a baseline level for a plurality of motion based behaviors, calculating a first percentage change of deviation from the baseline for a plurality of motion based behaviors, comparing the deviations to pre-set parameters, etc.”), which is an abstract idea included in the grouping of Mental Processes. These limitations are interpreted as at least Mental Processes insomuch as the claim limitations are directed to steps/concepts which are capable of being performed in the human mind, while only generically connected to interaction with a computer utilizing non-special purpose generic computing elements and/or insignificant extra-solution activity as set forth in the claims.
Regarding dependent claims 6, 14, and 20-34:
Each claim is dependent either directly or indirectly from the independent claim identified above and includes all the limitations of said independent claim. Therefore, each dependent claim recites the same abstract idea as identified above. Each of the dependent claim further describes additional aspects of the abstract idea, i.e., additional aspects to the Mental Processes and/or certain methods of organizing human activity. For example, some dependent claims merely provide additional Mental Processes and/or certain methods of organizing human activity Managing Personal Behavior or Relationships or Interactions Between People to be performed and/or additional insignificant extra-solution activity, without anything more significant to establish eligibility under 35 U.S.C. 101.
Step 2A-2 of the 2019 Revised Patent Subject Matter Eligibility Guidance
The second prong of step 2a is the consideration if the claim limitations are directed to a practical application.
Limitations that are indicative of integration into a practical application:
-Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
-Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
-Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
-Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
-Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitations that are not indicative of integration into a practical application:
-Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
-Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
-Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Claims 1-34 clearly do not improve the functioning of a computer, as they only incorporate generic computing elements, do not effect a particular treatment, and do not transform or reduce a particular article to a different state or thing. Similarly, there is no improvement to a technical field. In addition the claims do not apply the judicial exception with, or by use of a particular machine. The claims do not apply or use the judicial exception in a meaningful way. The claimed invention does not suggest improvements to the functioning of a computer or to any other technology or technical field (see MPEP 2106.05 (a)).
This judicial exception is not integrated into a practical application because the claimed invention merely applies the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform the abstract idea (MPEP 2106.05 (f)) and/or generally links the use of the judicial exception to a particular technology or field of use (MPEP 2106.05 (h)). The claimed computer components are recited at a level of generality and are merely invoked as tool to perform the abstract idea. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea.
For the reasons as discussed above, the claim limitations are not integrated to a practical application.
Step 2b of the 2019 Revised Patent Subject Matter Eligibility Guidance
Next, the claims as a whole are analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no element or combination of elements is sufficient to ensure any claim of the present application as a whole amounts to significantly more than one or more judicial exceptions, as described above. For example, the recitations of utilization of “electronic device, wearable device”, etc. used to apply the abstract idea merely implements the abstract idea at a low level of generality and fail to impose meaningful limitations to impart patent-eligibility. These elements and the mere processing of data using these elements do not set forth significantly more than the abstract idea itself applied on general purpose computing devices. The recited generic elements are a mere means to implement the abstract idea. Thus, they cannot provide the “inventive concept” necessary for patent-eligibility. “[I]f a patent’s recitation of a computer amounts to a mere instruction to ‘implement]’ an abstract idea ‘on ... a computer,’... that addition cannot impart patent eligibility.” Alice, 134 S. Ct. at 2358 (quoting Mayo, 132 S. Ct. at 1301). As such, the significantly more required to overcome the 35 U.S.C. 101 hurdle and transform the claimed subject matter into a patent-eligible abstract idea is lacking. Accordingly, the claims are not patent-eligible.
Further, the claims would require structure that is beyond generic, such as structure that can be interpreted analogous to a general-purpose structure and general-purpose computing elements in that they represent well-understood, routine, conventional elements that do not add significantly more to the claims. See Alice Corp. v. CLS Bank International, 134 S. Ct. at 2358-59. The elements of electronic device, that has a computer processor such as a smartphone or tablet as described in the specification, are well known conventional devices used to electronically implement the processing of data, such as defining data and determining data as evidenced by Kubota et al. (US 20100115587 A1; hereinafter Kubota) discloses that a conventional computing device is used to process data/information (¶72). Furthermore, the elements of a wearable device, that has sensors is well-known or conventional as evidenced by TEN KATE et al. (US 20210378550 A1; hereinafter TEN KATE). TEN KATE discloses that a conventional wearable device has sensors to monitor movement of the user (¶31-32). See Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).
The dependent claims do not add “significantly more” for at least the same reasons as directed to their respective independent claims, at least based on the position, as discussed above, that each of the dependent claims merely provide additional limitations to further expand the abstract idea of the independent claims, without adding anything which would establish eligibility under 35 U.S.C. 101.
Consequently, consideration of each and every element of each and every claim, both individually and as an ordered combination, leads to the conclusion that the claims are not patent-eligible under 35 USC §101.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1,6,10,15 and 20-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 10 recite the following limitation: “pre-set parameters comprising a positive reinforcement-generation condition” This limitation is not adequately described in the specification as originally filed and forms the basis of the rejection. As such, the limitations are reasonably rejected under a theory of new matter. Therefore, claims 1 and 10 are rejected under 35 U.S.C. § 112(a), as failing to comply with the written description requirement.
Claims 6,15 and 20-34 are rejected for being dependent upon a rejected base claim.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE ANGELES whose telephone number is (703)756-5338. The examiner can normally be reached Mon-Thu 8am-5pm.
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/JOSE ANGELES/Examiner, Art Unit 3715
/Jay Trent Liddle/Primary Examiner, Art Unit 3715
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