DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed February 4, 2026 has been acknowledged. Claims 1-5 and 7-8 remain pending in the application and are under examination.
Response to Arguments
Applicant’s arguments filed February 4, 2026 have been fully considered but are not persuasive or are moot.
Applicant argues, “Fleury does not disclose use of PID control, and does not disclose that parameters of PID control can be adjusted according to real-time obtained EEG” and that “Zanos does not disclose that the parameters of PID control and PID control manner can be updated in real-time when the input value is obtained and updated”.
Examiner acknowledges that Fleury teaches adaptively and dynamically monitoring and adjusting stimulation in real time [0543, 0547] and Zanos teaches using a PID controller that can be used to adjust stimulation parameters from the monitored parameters (col 16, ln 52-58). However, Examiner asserts in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 103 as unpatentable over Fleury et al. (US 2023/0031613) in view of Dundovic (WO 2021/026606) in view of Zanos et al. (US 11,938,324).
In re claim 1, Fleury discloses a helmet (fig 1: 100; [0162]) for mental state regulation [0531], comprising:
a helmet,
an electroencephalogram (EEG) acquisition module (fig 1A: 20; [0009, 0157]) set to the helmet ([0162]: device 100 including element 20 is set to the helmet),
a signal analysis module (fig 51; [0131]),
a vagus nerve stimulation module [0388] and
a vagus nerve stimulation ear nerve stimulator ([0388]: portion of device 100 that stimulates the auricular branch of the vagus nerve),
wherein
the EEG acquisition module is configured to
acquire an EEG signal of a target user in real-time [0143], and
preprocess the EEG signal to obtain a preprocessed EEG signal ([0346]: “amplify and filter”);
the signal analysis module is configured to extract EEG features of the preprocessed EEG signal (it is inherent that an EEG signal will have features extracted when being analyzed), and
the EEG features are input into a mental state assessment model to obtain a mental state value of the target user [0140];
the vagus nerve stimulation module is configured to
determine stimulation parameters of the vagus nerve stimulation ear nerve stimulator according to the mental state value of the target user, and
([0547]: it is apparent that in applying stimuluses to bring a user to a base state, that stimulation parameters are determined. However, insofar as this is not explicitly stated, it is additionally addressed below)
adjust the stimulation parameters adaptively and dynamically by obtaining the EEG features in real-time [0543; 0547]; and
the vagus nerve stimulation ear nerve stimulator is configured to stimulate a vagus nerve of skin of ears of the target user [0388].
and the stimulation parameters are adaptively and dynamically adjusted in real-time through the EEG features obtained in real-time [0143, 0543, 0547].
Fleury lacks
wherein the vagus nerve stimulator is a clip, and thus lacks
a vagus nerve stimulation ear clip;
… determine stimulation parameters of the vagus nerve stimulation ear clip,
the vagus nerve stimulation ear clip is configured to stimulate a percutaneous ear vagus nerve of the target user.
wherein
the vagus nerve stimulation module comprises a Proportional-Integral-Derivative (PID) control unit based on reinforcement learning,
the PID control unit based on the reinforcement learning is configured to input the EEG features obtained in real-time, and
Dundovic discloses a vagus nerve stimulation mental state therapy device [0001, 0158] wherein an ear clip (Fig. 1B) is used for the stimulation. Additionally, stimulation parameters for the device are determined [0046, 0062].
It would have been obvious to one of ordinary skill at the time the instant invention was filed to modify the system of Fleury by replacing the nerve stimulator with an ear clip (and to determine stimulation parameters), as taught by Dundovic, as it is a known technique for achieving this functionality and one of ordinary skill can choose from known alternatives. For example, an ear clip may ensure the stimulator is correctly positioned to properly stimulate the nerve and reduce the risk of moving during use which also makes it easier to use over prolonged periods of time (Dundovic: [0113, 0114]).
Zanos discloses an analogous vagus nerve stimulation device (abstract) that uses a Proportional-integral-derivative (PID) control unit based on reinforcement learning (col 16, lines 57-58).
It would have been obvious to one of ordinary skill in the art at the time the instant invention was filed to provide in the system of Fleury wherein the vagus nerve stimulation module comprises a Proportional-Integral-Derivative (PID) control unit based on reinforcement learning, as taught by Zanos, as use of PID control units is known in the present context, would yield predictable results, and one of ordinary skill can choose from available options. For example, PID control is known to provide accuracy and stability in a wide range of operations. Given that Fleury discloses real-time EEG processing/adjustment, such a modification would yield wherein the PID control unit based on the reinforcement learning is configured to input the EEG features obtained in real-time.
In re claim 2, Fleury discloses wherein the EEG acquisition module comprises
a preprocessing unit ([0346]: “amplify and filter”);
the preprocessing unit is configured to filter and amplify the EEG signal in turn to obtain the preprocessed EEG signal [0346].
In re claim 4, Dundovic discloses wherein the stimulation parameters comprise
a stimulation intensity [0200],
a stimulation frequency [0229] and
a stimulation duration [0196],
a frequency range is 0Hz-100Hz [0033], and
a duration range is 0Min-60Min [0196].
In re claim 5, Fleury discloses wherein the EEG acquisition module comprises
an EEG sensor (fig 2H: 20; [0009, 0157]),
the EEG sensor is located behind an interior of the helmet (apparent as it would be necessary to contact the user’s head).
Claim 3 is rejected under 35 U.S.C. 103 as unpatentable over Fleury et al. (US 2023/0031613) in view of Dundovic (WO 2021/026606) in view of Zanos et al. (US 11,938,324) in view of Avots et al. (Avots, Egils et al. “Ensemble Approach for Detection of Depression Using EEG Features.” Entropy (Basel, Switzerland) vol. 24,2 211. 28 Jan. 2022, doi:10.3390/e24020211), in view of Chen et al. (F. Chen et al., "Different Sub-bands Assessment of the Resting-state Prefrontal EEG in Depression Patients," 2022 International Conference on Sensing, Measurement & Data Analytics in the era of Artificial Intelligence (ICSMD), Harbin, China, 2022, pp. 1-6, doi: 10.1109/ICSMD57530.2022.10058461.), in view of Rosenfield (US 5450855).
In re claim 3, Fleury lacks wherein the EEG features comprise
spectral eigenvalues,
an Alpha brain wave asymmetry,
a Lempel-Ziv Complexity (LZC), and
a sample entropy.
However, these features are known EEG features to consider in mental state analysis. For example:
Regarding spectral eigenvalues and a Lempel-Ziv Complexity, see Avots ([4.1]: “power spectral density”, note: instant spec at [0043] indicates that spectral eigenvalues correspond to power spectral density; [2]);
Regarding an Alpha brain wave asymmetry, see Rosenfield ([13]: “depressed individuals have an abnormal electroencephalogram (EEG) pattern involving more left than right front alpha power”);
Regarding a sample entropy, see Chen (abstract).
It would have been obvious to one of ordinary skill in the art at the time the instant invention was filed to provide wherein the EEG features comprise any of the claimed features as these are known techniques for using EEG to determine mental states, as evidenced above, as one of ordinary skill can choose between available options based on the need of the application
Claim 7 is rejected under 35 U.S.C. 103 as unpatentable over Fleury et al. (US 2023/0031613) in view of Dundovic (WO 2021/026606) in view of Zanos et al. (US 11,938,324) in view of Yeow et al. (US 2017/0042439).
In re claim 7, Fleury discloses further comprising an audio playback module [0140],
wherein the audio playback module is configured to output audio corresponding to the real-time acquired EEG signal ([0140], last sentence).
Fleury lacks:
the audio playback module is configured to output music.
Yeow discloses a head worn mental state therapy device that determines a user’s mental state based on EEG and plays music accordingly [0190, 0191].
It would be obvious to one of ordinary skill at the time the instant invention was filed to modify the system of Fleury by using music for audio playback, as taught by Yeow, as it is a known form of audio for remedying undesired mental states used commonly and one of ordinary skill can choose from known alternatives.
Claim 8 is rejected under 35 U.S.C. 103 as unpatentable over Fleury et al. (US 2023/0031613) in view of Dundovic (WO 2021/026606) in view of Zanos et al. (US 11,938,324) in view of Sanaullah et al. (Sanaullah, R. N. Ali and M. F. Shahid, "An Novel Approach to Predict and Classify the Mental State of Person using EEG-based Brain-Computer Interface," 2022 International Conference on Emerging Technologies in Electronics, Computing and Communication (ICETECC), Jamshoro, Sindh, Pakistan, 2022, pp. 1-6, doi: 10.1109/ICETECC56662.2022.10069504.).
In re claim 8, Fleury discloses
the mental state assessment model is established by adopting a machine learning model [0156].
Fleury lacks wherein,
the mental state assessment model is established by adopting an eXtreme Gradient Boosting (XGBoost) model.
Sanaullah discloses that popular machine learning models, such as XGBoost, have been used to classify mental states (abstract).
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Fleury by using XGBoost as the machine learning system for mental state assessment, as taught by Sanaullah, as it is a known system for classifying mental states and one of ordinary skill can choose from known alternatives.
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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