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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/25/2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 08/25/2025 (“Amendment”). Claims 1-13 and 21-29 are currently under consideration. The Office acknowledges the amendments to claims 1, 7, and 12, as well as the addition of new claims 25-30. Claims 14-20 remain withdrawn, and newly added claim 30 is withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Information Disclosure Statement
The information disclosure statement filed 05/18/2025 fails to fully comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the lined-through reference therein has not been considered.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1 and 26 are objected to because of the following informalities:
Regarding claim 1, the recitation of “wherein said scenario further comprising” should instead read –wherein said scenario further comprises--.
Regarding claim 26, the recitation of “wherein said modify comprises modify” should instead read –wherein said modifying comprises modifying--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-13 and 21-29 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 pre-AIA the applicant regards as the invention.
The term “stress-related” in claims 1, 3, 5, 7, 8, 10-13, 23, and 24 is a relative term which renders the claims indefinite. The term is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, what brain areas are considered stress-related? The disclosure seems to imply that areas e.g. besides the amygdala are contemplated, but it is unclear what those areas are or how they are determined.
Regarding claim 29, there is insufficient antecedent basis for the recitation of “said desired resilience level.”
Regarding claims 2-13 and 21-29, there is insufficient antecedent basis for the recitation of “said reference EEG signature.”
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.
Claims 1-11, 13, 21-26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of US Patent Application Publication 2019/0159715 (“Mishra”) in view of US Patent Application Publication 2009/0069707 (“Sandford”).
Regarding claim 1, Mishra teaches [a] method for resilience training (Abstract, cognitive fitness training) based on neurofeedback control (Fig. 1, feedback, ¶ 0123) of a selected deeply located brain area (¶ 0082, amygdala, ¶ 0083, mesolimbic pathway), comprising: (a) providing an EEG signature (¶ 0184 (EEG); ¶¶s 0185, 0186, etc. (neural signatures associated with high cognitive performance); ¶ 0059, evaluating neural performance relative to various standards such as a subject’s prior performance or the level equivalent to an average healthy subject) indicating activity and/or a change in activity of at least one selected deeply located stress-related brain area (as above, detecting activity from the amygdala); (b) exposing a healthy human subject to … one or more stress-evoking perturbations selected to affect activation of said at least one selected deeply located stress-related brain area, wherein said at least one selected deeply located stress-related brain area is a brain region activated in a response of said healthy human subject to stress (Fig. 1, stimulus 101; as above, detecting activity from the amygdala; ¶¶s 0006, 0007, 0027, 0047, etc., “brain training” includes improving cognitive function of healthy individuals); (c) instructing said healthy human subject to perform during said exposing, at least one activity configured to [selectively affect activation of said at least one selected deeply located stress-related brain area] (Fig. 1, behavioral response 103; ¶ 0057, instructing the individual to perform a task of e.g. identifying or recognizing a particular stimulus, and e.g. acting on it by pressing a button, ¶¶s 0065, 0066, 0183, etc.); (d) recording EEG signals from said healthy human subject during said exposing (Fig. 1, ¶ 0087, etc.); (e) analyzing said recorded EEG signals using said EEG signature to determine an activation level of said at least one selected deeply located stress-related brain area (¶ 0059, evaluating neural performance relative to various standards such as a subject’s prior performance or the level equivalent to an average healthy subject – also see ¶ 0185, describing the calculation of average cognitive efficiency); (f) delivering a human-detectable indication to said healthy human subject … according to said determined activation level (¶ 0123, neural performance level is provided as feedback to the subject. Although it is not explicit that this feedback is relative to levels of e.g. a healthy population (or a subject’s own baseline), ¶ 0115 teaches providing feedback as positive or negative indicators based on desired or undesired outcomes. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to present feedback/indications that are relative to a healthy reference, for the purpose of letting the subject know how they compare (¶ 0115), as well as for showing them their degree/progress in training (¶¶s 0124, 0125, training and feedback with respect to baselines/thresholds)); and repeating said (b) to (f) to increase a resilience of said healthy human subject when exposed to stress-evoking perturbations in the future, wherein said healthy human subject is a subject not diagnosed with a stress-related mental health disturbance (¶ 0124, the training program including multiple rounds of tasks and multiple sessions).
Mishra does not appear to explicitly teach exposing the subject to a scenario comprising objects which determine an agitation level of the scenario, instructing the subject to perform during said exposing an activity configured to lower said agitation level of the scenario, and delivering an indication to the subject by modifying said agitation level of the scenario (although e.g. ¶ 0118 does describe presenting a cognitive task in the form of e.g. a video game, and providing feedback as in-game rewards or penalties).
Sandford teaches a video-game based neurofeedback modality that e.g. slows down objects to make them easier to hit when a user is focusing (i.e., achieving a desired mental state or activation level), and speeding them up otherwise (¶ 0015).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the video-game based neurofeedback of Mishra as in Sandford, by e.g. presenting moving target objects that determine an agitation level, instructing users to perform an activity such as paying attention or focusing, and delivering an indication by slowing down the moving objects in response to the activity, for the purpose of enhancing neurofeedback training (Sandford: ¶ 0015), and as the simple substitution of one known means of neurofeedback training for another with predictable results (helping users focus via a reward mechanism).
Regarding claim 2, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches wherein said at least one activity comprises at least one mental activity or at least one physical activity (Mishra: Fig. 1, behavioral response 103; ¶ 0057, instructing the individual to perform a task of e.g. identifying or recognizing a particular stimulus, and e.g. acting on it by pressing a button, ¶¶s 0065, 0066, 0183, etc.; Sandford: ¶ 0015, focusing or paying attention).
Regarding claim 3, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches wherein said recording comprises recording EEG signals from said healthy human subject during and/or following the performing of said one or more activities (Mishra: Fig. 1, closed loop, ¶ 0123), and wherein said determining comprises determining an activation level and/or a change in activation level of said at least one selected deeply located stress-related brain area based on an identified relation between said EEG signature indicating said activation level and/or said change in activation level and said analyzed recorded EEG signals (Mishra: ¶ 0059, evaluating neural performance relative to various standards such as a subject’s prior performance or the level equivalent to an average healthy subject – also see ¶ 0185, describing the calculation of average cognitive efficiency).
Regarding claim 4, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches wherein said delivering comprises modifying said one or more stress-evoking perturbations according to said determined activation level during said exposing (Mishra: ¶ 0123, modifying the subsequent task; Sandford: ¶ 0015, e.g. slowing targets down).
Regarding claim 5, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches selecting said at least one activity out of two or more activities based on an ability of said at least one activity to selectively affect activation of said at least one selected deeply located stress-related brain area when performed by said healthy human subject (Mishra: ¶ 0011, adapting a cognitive task based on neural performance level; ¶ 0027, the adaptation including a second cognitive task. This means there is selection between cognitive tasks; ¶ 0057, the tasks are related to activity in particular brain regions – also see ¶¶s 0063, 0118, etc., about particular/desired brain regions).
Regarding claim 6, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches wherein said one or more stress-evoking perturbations are perturbations selected to induce a stress response in said healthy human subject (Mishra: ¶ 0057, the tasks require exertion to identify or recognize a stimulus; ¶ 0074, monitoring neurophysiological parameters such as heart rate variability; ¶ 0130, training to improve attention regulation ability, etc.).
Regarding claims 7 and 8, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches wherein said at least one selected deeply located stress-related brain area, is a brain region related to a stress-related system located underneath the brain cortex, wherein said at least one selected deeply located stress-related area comprises an amygdala (Mishra: ¶ 0082, amygdala (limbic system)(limbic lobe)).
Regarding claim 9, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches wherein said timed relation comprises prior-to, during and/or after said exposing (Mishra: Fig. 1, behavioral response 103; ¶ 0057, instructing the individual to perform a task of e.g. identifying or recognizing a particular stimulus (after being exposed to it), and e.g. acting on it by pressing a button, ¶¶s 0065, 0066, 0183, etc.).
Regarding claim 10, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches wherein said at least one activity activates brain regions or neural circuits which relate to activation control of said at least one selected deeply located stress-related brain area (Mishra: ¶ 0057, the tasks require exertion to identify or recognize a stimulus; ¶ 0074, monitoring neurophysiological parameters such as heart rate variability; ¶ 0130, training to improve attention regulation ability, etc.; each of these suggest monitoring during exertion or stress; ¶ 0082, measuring amygdala activation. It is known that exertion or stress (including fear) trigger the amygdala (¶ 0407 of the present application as published). In any case, the contemplated stimuli activate the amygdala, which is then monitored for changes as described in ¶ 0082).
Regarding claim 11, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches identifying a relation between said analyzed recorded EEG signals and said provided EEG signature, and wherein said activation level of said at least one selected deeply located stress-related brain area is determined based on said identified relation (Mishra: ¶ 0059, evaluating neural performance relative to various standards such as a subject’s prior performance or the level equivalent to an average healthy subject).
Regarding claim 13, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches delivering an indication regarding a resilience of said healthy subject based on a change in said determined activation level of said at least one selected deeply located stress-related brain area following performing of said at least one activity, wherein said resilience is an ability of said healthy subject to resist and/or overcome deleterious short- and or long-term effects associated with a stressor (Mishra: ¶¶s 0132 and 0133, using an assessment/analysis to provide feedback to the subject about their post-training abilities. It would have been obvious to use the display contemplated by ¶ 0159 to deliver this indication, for the purpose of re-using an existing component for the same purpose (providing information to the subject), thereby conserving resources).
Regarding claim 21, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches wherein said healthy human subject is a subject not diagnosed with post-traumatic stress disorder (PTSD), and wherein said repeating comprises repeating said (b) to (f) to prevent development of said PTSD in the future by said healthy human subject (Mishra: as above, ¶¶s 0006, 0007, 0027, 0047, etc. describe “brain training” as improving cognitive function of healthy individuals).
Regarding claim 22, Mishra-Sandford teaches all the features with respect to claim 21, as outlined above. Mishra-Sandford further teaches wherein said healthy human subject has higher probability to develop PTSD in the future compared to other healthy human subjects (this kind of subject falls within the scope of healthy subjects that can be trained according to the teachings of Mishra).
Regarding claim 23, Mishra-Sandford teaches all the features with respect to claim 21, as outlined above. Mishra-Sandford further teaches wherein said instructing comprises instructing said healthy human subject to perform during said exposing, at least one activity configured to downregulate activity of said at least one selected deeply located stress-related brain area (Mishra: ¶ 0165, “people who … are at risk for cognitive impairment can benefit from the methods and systems of the present disclosure” – whether or not the subject has a condition such as PTSD, the training activities are meant to downregulate a stress response – “the present invention can be useful in combating … stress” – also see ¶ 0082, determining whether the measured activity (including amygdala activity) is e.g. decreased).
Regarding claim 24, Mishra-Sandford teaches all the features with respect to claim 23, as outlined above. Mishra-Sandford further teaches wherein said at least one selected deeply located stress-related brain area comprises an amygdala (Mishra: ¶ 0082, amygdala, ¶ 0083, mesolimbic pathway).
Regarding claim 25, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches wherein said objects comprise moving visual objects, and wherein movement of said moving visual objects in said scenario determines said agitation level of said scenario (Sandford: ¶ 0015, moving targets).
Regarding claim 26, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches wherein said modify comprises modify a behavior of one or more of the objects in the scenario (Sandford: ¶ 0015, slowing the targets down).
Regarding claim 28, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford further teaches wherein said repeating comprises repeating said (b) to (f) in an amount sufficient to reach a desired resilience level of said healthy human subject (Mishra: ¶ 0124, the training program including multiple rounds of tasks and multiple sessions, until a desired level of cognitive fitness is achieved).
Claims 12, 27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of US Patent Application Publication 2019/0159715 (“Mishra”) in view of US Patent Application Publication 2009/0069707 (“Sandford”) and US Patent Application Publication 2011/0263968 (“Quattrocki-Knight”).
Regarding claim 12, Mishra-Sandford teaches all the features with respect to claim 11, as outlined above. Mishra-Sandford further teaches wherein said EEG signature comprises an fMRI-based EEG model … of said at least one selected deeply located stress-related brain area, wherein said fMRI-based EEG model is generated by calculating a correlation between one or more measured EEG signals, and … activity of said at least one selected deeply located stress-related brain area as monitored by fMRI (Mishra: ¶ 0090 describes combined MRI and EEG to create a reference model of the brain with detected neural activity “co-registered” thereon – also see claims 18 and 30, describing measuring both. It would have been obvious to use fMRI data as part of the reference data, for the purpose of using the contemplated combined recording to assess neural performance more comprehensively (¶ 0059), especially by localization on a brain map (¶ 0090)).
Mishra-Sandford does not appear to explicitly teach the model as indicating Blood-Oxygen-Level-Dependent (BOLD) activity.
Quattrocki-Knight teaches, in a system for training a subject to modify their own neutronal activity within a selected brain region (Abstract), using fMRI to measured BOLD T2* weighted signal changes as an indirect way of visualizing neuronal activity in a localized brain area (¶ 0038).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use BOLD activity from the fMRI data of the combination, as in Quattrocki-Knight, in the model already contemplated, since BOLD activity is the relevant fMRI feature that allows a patient to visualize their own neuronal activity (Quattrocki-Knight: ¶ 0038), thus enabling the feedback contemplated (Mishra: ¶ 0123; Quattrocki-Knight: ¶ 0002).
Regarding claim 27, Mishra-Sandford teaches all the features with respect to claim 1, as outlined above. Mishra-Sandford does not appear to explicitly teach wherein said scenario comprises sound of said objects, wherein said objects and said sound determine said agitation level of said scenario (although Mishra ¶ 0101 teaches providing an auditory stimulus, ¶ 0115 teaches that the auditory stimuli include positive and negative feedback, and Sandford ¶ 0007 teaches that audio feedback can be used to make the neurofeedback training more interesting and game-like).
Quattrocki-Knight teaches providing both visual and auditory neurofeedback together (¶ 0034).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate sound information that corresponds to agitation level with the objects of the combination, thereby providing both visual and sound data related to the objects, as in Quattrocki-Knight, for the purpose of making the training more interesting and game-like (Sandford: ¶ 0007).
Regarding claim 29, Mishra-Sandford-Quattrocki-Knight teaches all the features with respect to claim 27, as outlined above. Mishra-Sandford-Quattrocki-Knight further teaches wherein said desired resilience is determined according to the level of stress the subject is expected to feel and/or according to the intensity of stress-evoking perturbations the subject is expected to encounter in the future (Mishra: ¶ 0124, training until a desired level of cognitive fitness is achieved, or until a desired result is achieved. It would have been obvious to train until a user was able to handle expected events so that they could handle those events).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 and 21-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of copending Application No. 17/342,753 in view of Mishra, Sandford, and/or Quattrocki-Knight. Claim 1 of the reference application teaches all features except for those made up for by Mishra, Sandford, and/or Quattrocki-Knight as outlined above
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s amendments and arguments filed 08/25/2025 have been fully considered, and they are persuasive to the extent that Mishra is not explicit regarding the new claim limitations. However, a new grounds of rejection has been made in further view of Sandford, and all claims remain rejected in light of the prior art. The arguments with respect to Mishra not appearing to focus on training a healthy subject are not persuasive for reasons already of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408)918-7617. The examiner can normally be reached Monday - Friday 7 am - 3 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached on (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791