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 .
Status of Claims
This action vacates prior action mailed 4/7/2026 and re-starts Applicant’s period for reply.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Drawings
The drawings are objected to because Fig. 5 is not at sufficient resolution such that the text can be read. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: ¶[0075] of the Specification filed 6/18/2024 has a typographical error, “EGG” instead of “EEG”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: sensor unit, control unit, and stimulation unit in claims 1-12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For sensor unit, corresponding disclosure appears to be found in ¶¶[0075-0078].
For control unit, corresponding disclosure appears to be found in ¶[0132].
For stimulation unit, corresponding disclosure appears to be found in ¶¶[0138-0141].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boyle et al. (U.S. Patent Application Publication No. 2016/0256105) hereinafter referred to as Boyle; in view of Hagedorn (U.S. Patent Application Publication No. 2021/0393955) hereinafter referred to as Hagedorn.
Regarding claim 1, Boyle teaches a personalized (¶[0003] individualized, ¶[0006] detecting from the subject and administering based on subject data) brain stimulation device (Abstract) comprising:
a sensor unit that measures biological information of an object (¶[0145] EEG);
a control unit (¶[0025], ¶[0128]) that determines, based on the biological information of the object measured by the sensor unit, the state of the object (¶[0147]); and
a stimulation unit that delivers a stimulus (¶[0149]), which varies according to the first state determined by the control unit (¶[0147]), to a brain of the object (Fig. 1) to entrain synchronized oscillation in multiple regions of the brain of the object (¶[0041], ¶[0057], ¶[0167]),
wherein the stimulus is a first stimulus to entrain gamma oscillation synchronized in multiple regions of the brain (¶[0057], ¶[0117]), a second stimulus to entrain any one of delta, theta, alpha, and beta oscillation synchronized in multiple regions of the brain (¶[0057]), or a third stimulus that combines the first stimulus and the second stimulus (¶[0057]), wherein the first, second, and third stimulus are an transcranial alternating current stimulation (tACS) (¶¶[0123-0124]), and wherein the transcranial alternating current stimulation switches on and off according to a predetermined first frequency, and is a first combined stimulus that applies the signal switched on according to the first frequency as stimulus according to a predetermined second frequency (¶¶[0056-0057]).
Boyle does not teach determining, based on the biological information of the object measured by the sensor unit, that the state of the object corresponds to a first state among a predetermined plurality of depression-related states.
Attention is brought to the Hagedorn reference, which teaches determining, based on biological information of an object measured by a sensor unit (¶[0072]), that the state of the object corresponds to a first state among a predetermined plurality of depression-related states (¶[0130], ¶[0137], ¶[0151]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the transcranial stimulation of Boyle to include diagnosing a brain malady including depression-related states, as taught by Hagedorn because the processing of Hagedorn improves patient diagnosis and efficacy of treatment with tailored treatment protocols (Hagedorn ¶[0170]).
Regarding claim 2, Boyle as modified teaches the personalized brain stimulation device according to claim 1.
Boyle further teaches wherein the biological information comprises at least one of electroencephalogram (EEG) information (¶[0147]).
Hagedorn further teaches wherein the biological information comprises at least one of heart rate variability (HRV) information (¶[0043], ¶[0128]), electroencephalogram (EEG) information (¶[0035]), heart rate information (¶[0047]), stress information (¶[0052]), body composition information (¶[0059] skin conductance), pulse information (¶[0059]), blood pressure information (¶[0059]), iris information (¶[0043]), vein information (¶[0059]), and electrocardiogram (ECG) information (¶[0059]).
Regarding claim 3, Boyle as modified teaches the personalized brain stimulation device according to claim 1.
Hagedorn further teaches wherein the predetermined plurality of depression-related states comprise a depressive disorder state caused by stress, a major unipolar depression (MDD) state, and a bipolar disorder (BD) state (¶[0137], ¶[0163]), ¶[0189].
Regarding claim 4, Boyle as modified teaches the personalized brain stimulation device according to claim 3.
Hagedorn further teaches wherein the stimulation unit delivers the first stimulus to the brain when the first state determined by the control unit is the major unipolar depression state (Fig. 16, ¶[0130], ¶[0137], ¶[0151]).
Boyle further teaches wherein the delivery of the first stimulus enhances a gamma-level brain wave in a brain wave of the object through the entrainment of gamma oscillation for the treatment of depression (¶[0066], Table 1).
Regarding claim 5, Boyle as modified teaches the personalized brain stimulation device according to claim 4.
Hagedorn further teaches wherein the stimulation unit delivers the second stimulus to the brain when the first state determined by the control unit is the depressive disorder state caused by stress (Fig. 16, ¶[0130], ¶[0137], ¶[0151]).
Boyle further teaches wherein the delivery of the second stimulus reduces the gamma-level brain wave in the brain wave of the object through the entrainment of any one of delta, theta, alpha, and beta oscillation (¶[0066], Table 1, ¶[0057]).
Regarding claim 6, Boyle as modified teaches the personalized brain stimulation device according to claim 5.
Hagedorn further teaches wherein the stimulation unit delivers the third stimulus to the brain when the first state determined by the control unit is the bipolar disorder state (Fig. 16, ¶[0130], ¶[0137], ¶[0151]).
Boyle further teaches wherein, when the first state of the object is the bipolar disorder state and the gamma-level brain wave in the brain wave of the object is the lowest, the first stimulus is delivered to the brain to enhance the gamma-level brain wave in the brain wave of the object, and wherein, when the first state of the object is the bipolar disorder state and the gamma-level brain wave in the brain wave of the object is the highest, the second stimulus is delivered to the brain to reduce the gamma-level brain wave in the brain wave of the object (¶[0066], Table 1, ¶[0057]).
Regarding claim 7, Boyle as modified teaches the personalized brain stimulation device according to claim 2.
Boyle further teaches wherein the brain wave information is the first brain wave obtained from the brain, wherein the sensor unit measures the second brain wave of the object while the stimulus is being delivered to the brain, and wherein the control unit determines whether a first response, which entrains synchronized oscillation in multiple regions of the brain of the object, is derived based on the second brain wave of the object measured by the sensor unit (Fig. 1, ¶[0147]).
Regarding claim 8, Boyle as modified teaches the personalized brain stimulation device according to claim 1.
Boyle further teaches wherein the first frequency is applied to induce the entrainment of synchronized oscillation in multiple regions of the brain of the object, wherein the second frequency is applied to induce membrane action potential and brain oscillation in multiple regions of the brain of the object, and wherein the second frequency is higher than the first frequency (¶[0041], ¶[0057], Table 1).
Regarding claim 9, Boyle as modified teaches the personalized brain stimulation device according to claim 8.
Boyle further teaches wherein the control unit processes the first signal caused by the first combined stimulus as noise from the signals measured by the sensor unit, and wherein the control unit determines whether the first response is derived based on the second signal excluding the first signal from the signals measured by the sensor unit (¶[0154] filtered EEG to check alpha power against stimulation threshold, if alpha power below a threshold, do not modify the stimulation).
Regarding claim 10, Boyle as modified teaches the personalized brain stimulation device according to claim 9.
Boyle further teaches wherein the control unit, when the first response according to the first combined stimulus is not derived, controls the stimulation unit to deliver a second combined stimulus to the brain of the object that at least one of the first frequency, the second frequency, and the output, the waveform and the period of the stimulus according to the second frequency is modified (¶[0154] filtered EEG to check alpha power against stimulation threshold, if alpha power too high, alter the stimulation).
Regarding claim 11, Boyle as modified teaches the personalized brain stimulation device according to claim 10.
Boyle further teaches wherein the first response is related to the entrainment of gamma oscillation or any one of delta oscillation, theta oscillation, alpha oscillation and beta oscillation synchronized in multiple regions of the brain, and wherein the first frequency is 30Hz to 80Hz to entrain the gamma oscillation synchronized in multiple regions of the brain of the object including the prefrontal cortex (PFC) and hippocampus of the object (this is an intended use, the combination of Boyle and Hagedorn is capable of said use), 14Hz to 29Hz to entrain the beta oscillation, 8Hz to 13Hz to entrain the alpha oscillation, 4Hz to 7Hz to entrain the theta oscillation, or a frequency greater than 0Hz and less than 4Hz to entrain the delta oscillation (¶[0057], Table 1, ¶[0175]).
Regarding claim 12, Boyle as modified teaches the personalized brain stimulation device according to claim 11.
Boyle further teaches wherein, based on the magnitude of the first signal being different from the magnitude of the second signal by at least a predetermined value, the signal interference caused by the first combined stimulus is negligible (¶[0117]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2021/0299447 to Fitzgerald et al. teaches tACS based on closed-loop control.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792
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