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 Arguments
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive.
Applicant 1st argues on page 7 “As an initial matter, Boyle does not disclose any connection between alpha-frequency transcranial stimulation and DMN dysfunction and associated disorders. Boyle describes that stimulation can be applied in the delta frequency band, theta frequency band, alpha frequency band, beta frequence band, or gamma frequency band (Boyle, paragraph [0057]), but does not connect any of the aforementioned frequency bands to particular disorders, such as those associated with DMN dysfunction. So, while Boyle provides a laundry list of disorders that may be treated with transcranial stimulation (see, e.g., Boyle, paragraph [0097]), Boyle does not disclose which disorders are treated by which frequency band of transcranial stimulation”.
The examiner is not persuaded. [0019]-[0021] of Boyle teach the therapeutic benefit of stimulating in the α-tACS range ([0021] of Boyle states “10 Hz-tACS increased creative thinking across all subscales”). [0057] discloses “oscillations in the alpha frequency band (8-13 Hz)” may be used, and that the stimulation may “increase the synchronization of cortical oscillations within a first brain region of a subject's brain, to increase the synchronization of cortical oscillations in a first region of a subject's brain with cortical oscillations in a second region of the subject's brain”. [0097] teaches disorders associated with DMN dysfunction including Alzheimer's disease, schizophrenia, autism, or posttraumatic stress disorder (PTSD). Thus, Boyle is stimulating in the α-tACS range (e.g. see [0019]-[0021], [0057]) to enhance neural synchrony (e.g. see [0057]) to treat the same patient population (disorders associated with DMN dysfunction) (e.g. see [0097]). The applicant asserts in the arguments above a self-imposed, manufactured, artificial precondition that there must be a direct link between α-tACS stimulation and DMN dysfunction for the examiner to apply the prior art. However, the DMN function/dysfunction is a patient symptom that will be treated since prior art administers the same α-tACS stimulation (e.g. see [0019]-[0021], [0057]) to the same patient population (e.g. see [0097]) to enhance neural synchrony (e.g. see [0057). The applicant should distinguish the claims from the prior art in terms of the stimulation administered, not patient response.
Applicant 2nd argues on pages 8-9, “As described in Applicant's specification, enhancing neural synchrony using α-tACS requires precise high-definition stimulation methods that target oscillations across the brain, not just locally as in Boyle. (See Specification, paragraphs [0031]-[0032]). For example, an array of five electrodes may be used to precisely channel stimulation in such a way that effectively targets oscillations in the alpha-frequency across the brain to enhance DMN communication and functional integrity. (Specification, paragraphs [0036]-[0038]). In other words, the methods of the present invention utilize a high-definition stimulation montage to specifically target the primary cortical source of alpha oscillations, unlike Boyle which lacks specificity regarding the alpha rhythm itself and in articulating the physiological rational for the chosen stimulation site. Targeting rhythmic (oscillatory) communications across the DMN in the manner claimed was not known in the art, and Applicant's claimed method demonstrates a critical improvement in the enhancement of DMN neural synchrony and/or communication for treating DMN dysfunction and associated neurological disorders.
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., high-definition stimulation and an array of five electrodes) 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).
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boyle et al. (Pub. No.: US 2016/0256105 A1); hereinafter referred to as “Boyle”.
Regarding claims 1, 9, and 15, Boyle discloses a method of treating disorders associated with default mode network (DMN) dysfunction in a patient in need thereof (e.g. see [0097]), the method comprising: administering alpha-frequency transcranial alternating current stimulation (α-tACS) to the brain of the patient via at least one electrode (e.g. see [0019]-[0021]. Note: The applicant defines the alpha range as 8-12 Hz. 10 Hz is within that range. Also, the stimulation is transcranial alternating current), wherein the α-tACS (e.g. see [0019]-[0021]) targets a primary rhythm of neural synchrony in the brain (e.g. see [0057], [0041]. Note: [0057] discloses “oscillations in the alpha frequency band (8-13 Hz)” may be used, and that the stimulation may “increase the synchronization of cortical oscillations within a first brain region of a subject's brain, to increase the synchronization of cortical oscillations in a first region of a subject's brain with cortical oscillations in a second region of the subject's brain”) associated with DMN functioning (e.g. see [0097]) to enhance neural synchrony (e.g. see [0057], [0041]), which is effective to regulate DMN dysfunction and treat disorders associated therewith (e.g. see [0097], which teaches treating disorders associated with DMN dysfunction).
Regarding claims 2 and 14, Boyle discloses the disorder associated with DMN dysfunction is selected from normal or abnormal aging, cognitive impairment, or neuropsychiatric disorders such as Alzheimer's disease, schizophrenia, autism, or posttraumatic stress disorder (PTSD) (e.g. see [0097]).
Regarding claim 3, Boyle discloses the α-tACS is administered to the occipitoparietal cortex of the brain of the patient (e.g. see [0156]).
Regarding claims 4 and 16, Boyle discloses the at least one electrode comprises a plurality of electrodes positioned on and/or around the midline of the occipitoparietal cortex (e.g. see [0156]).
Regarding claims 5, 10, and 17 Boyle discloses the closed-loop circuit of electrodes comprises a central electrode and four peripheral electrodes (e.g. see [0019], [0147]).
Regarding claim 6, Boyle discloses the plurality of electrodes form a closed-loop circuit (e.g. see [0147]).
Regarding claims 7 and 13, Boyle discloses the α-tACS is administered to the patient's brain for a period at least 10 minutes or least 20 minutes (e.g. see [0171]).
Regarding claims 8, 12, and 18-19, Boyle discloses the α-tACS comprises sinusoidal current up to 3 mA, oscillating at 8 Hz to 12 Hz (e.g. see [0175]).
Regarding claim 11, Boyle discloses the primary rhythm of neural synchrony is the alpha-frequency in the brain (e.g. see [0019]-[0021]).
Regarding claim 20, Boyle discloses the α-tACS comprises a sinusoidal current at 2 mA, oscillating at 10 Hz (e.g. see [0175], “2 mA peak-to-peak 10 Hz sine wave”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Javitt et al. (Pub. No.: US 2020/0107777 A1), Hermosillo et al. (Pub. No.: US 2023/0115330 A1), Aboud et al. (Pub. No.: US 2023/0166109 A1), Lee et al. (Pub. No.: US 2023/0211159 A1), and Koch et al. (Pub. No.: US 2023/0381512 A1).
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.
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792