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 6/11/2026 have been considered but are not
persuasive in view of the new grounds of rejection as necessitated by the applicant’s
claim amendments.
Applicant argues on page 7: “Dolev does not describe sequentially stimulating each of a plurality of locations within a brain region of a subject, where the brain region is among a plurality of brain regions forming a functional brain network of the subject. Rather, Dolev describes a "a non-iterative stimulation event" (para. [0079]) that involves applying a stimulation burst to an entire brain region. (See, e.g., Dolev para. [0090] and FIG. 4). At least because Dolev does not describe sequentially stimulating each of a plurality of locations within a brain region, Dolev also necessarily does not describe personalized stimulation parameters including a location of stimulation within the brain region as claimed. For at least these reasons, amended claim 31 patentably distinguishes Dolev, and is respectfully requested that the rejection under § 102 of claim 31 and all claims that depend therefrom be withdrawn.”.
The examiner has revised the rejection to address the new claim language and related arguments. The rejection now cites Dolev in view of Geva et al. (Pub. No.: US 2017/0216595 A1); hereinafter referred to as “Geva”. The following has been added to the rejection for independent claims 31 and 42:
“Dolev discloses stimulating each of a plurality of locations within a brain region of the subject (e.g. see figure 3, [0086]-[0090], figures 11-13, [0108]-[0111]) but is vague as to sequentially stimulating each of a plurality of locations within a brain region of the subject, wherein the brain region is a first brain region of a plurality of brain regions forming a functional brain network in the brain of the subject. Geva teaches it is known to sequentially stimulate each of a plurality of locations within a brain region of the subject, wherein the brain region is a first brain region of a plurality of brain regions forming a functional brain network in the brain of the subject as taught in [0020]-[0022], figure 2, [0123], [0184] (Note: “plurality of different brain locations and a plurality of different times” in [0020]-[0022] will read on sequentially stimulating a plurality of brain regions) to provide a closed loop that can be used to effect many types of changes in brain function including local neuroplasticity (e.g. see [0184]) in a TMS device (e.g. see [0151]-[0152]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use such a modification as taught by Geva in the system/method of Dolev, since said modification would provide the predictable results of a closed loop that can be used to effect many types of changes in brain function including local neuroplasticity in a TMS device”.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 31-36, 38, 40-47, 49, 51, and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dolev et al. (Pub. No.: US 2018/0008827 A1); hereinafter referred to as “Dolev”, in view of Geva et al. (Pub. No.: US 2017/0216595 A1); hereinafter referred to as “Geva”.
Regarding claims 31 and 42, Dolev discloses a method for determining personalized stimulation parameters for stimulation of a brain of a subject (e.g. see [0086]-[0095]), the method comprising steps of: stimulating each of a plurality of locations within a brain region of the subject (e.g. see figure 3, [0086]-[0090], figures 11-13, [0108]-[0111]); sensing a plurality of evoked potentials in response to stimulating the plurality of locations within the brain region of the subject (e.g. see figure 4, [0090]-[0098]); and determining, based at least in part on at least one characteristic of the plurality of evoked potentials (e.g. see figure 4, [0090]-[0098]), personalized stimulation parameters for the subject, wherein the personalized stimulation parameters include a location of stimulation within the brain region (e.g. see [0067], [0108]-[0111], “electrode location”).
Dolev discloses stimulating each of a plurality of locations within a brain region of the subject (e.g. see figure 3, [0086]-[0090], figures 11-13, [0108]-[0111]) but is vague as to sequentially stimulating each of a plurality of locations within a brain region of the subject, wherein the brain region is a first brain region of a plurality of brain regions forming a functional brain network in the brain of the subject. Geva teaches it is known to sequentially stimulate each of a plurality of locations within a brain region of the subject, wherein the brain region is a first brain region of a plurality of brain regions forming a functional brain network in the brain of the subject as taught in [0020]-[0022], figure 2, [0123], [0184] (Note: “plurality of different brain locations and a plurality of different times” in [0020]-[0022] will read on sequentially stimulating a plurality of brain regions) to provide a closed loop that can be used to effect many types of changes in brain function including local neuroplasticity (e.g. see [0184]) in a TMS device (e.g. see [0151]-[0152]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use such a modification as taught by Geva in the system/method of Dolev, since said modification would provide the predictable results of a closed loop that can be used to effect many types of changes in brain function including local neuroplasticity in a TMS device.
Regarding claims 32 and 43, Dolev discloses the step of sequentially stimulating each of a plurality of locations within a brain region of the subject comprises sequentially stimulating each of the plurality of locations using transcranial magnetic stimulation (TMS) (e.g. see [0073], [0090], [0094]).
Regarding claims 33 and 44, Dolev discloses the step of sequentially stimulating using transcranial magnetic stimulation (TMS) comprises sequentially stimulating using single-pulse TMS (e.g. see [0073], figure 2A element 220).
Regarding claims 34 and 45, Dolev discloses the step of sensing a plurality of evoked potentials comprises sensing a plurality of evoked potentials using one or more electroencephalography (EEG) electrodes arranged on a scalp of the subject (e.g. see [0103], figure 7 step 704).
Regarding claims 35 and 46, Dolev discloses the personalized stimulation parameters further include one or more stimulation characteristics, the one or more stimulation characteristics including a personalized intensity of stimulation (e.g. see [0103]) and/or a personalized frequency (e.g. see [0057], [0081]) of stimulation.
Regarding claims 36 and 47, Dolev discloses sensing a resting motor threshold in response to providing non-invasive stimulation of a motor cortex region of the brain of the subject (see [0012] and “transcranial magnetic stimulation” is the non-invasive stimulation as disclosed in [0094]); determining a baseline intensity of stimulation based, at least in part, on the resting motor threshold; and adjusting the baseline intensity of stimulation based, at least in part, on the personalized stimulation parameters (e.g. see figures 5-7, “motor threshold” in [0099]-[0103]).
Regarding claim 38 and 49, Dolev discloses providing non-invasive stimulation to the determined location of stimulation of the brain of the subject, wherein the non-invasive stimulation comprises transcranial magnetic stimulation (e.g. see [0073], [0090], [0094]).
Regarding claims 40 and 51, Dolev discloses monitoring peak potentials to determine plasticity of different brain regions (e.g. see [0090]) but is silent as to the step of determining the personalized stimulation parameters comprises selecting a location of stimulation from the plurality of locations having a largest peak magnitude of the plurality of evoked potentials. Geva teaches that it is known to use such a modification as set forth in [0125], [0205], [0456], [0520] to improve the synchronization among different brain regions (e.g. see [0145]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the region with the largest peak as taught by Geva in the system/method of Dolev, since said modification would provide the predictable results of improving the synchronization among different brain regions.
Regarding claims 41 and 52, Dolev discloses the at least one characteristic of the plurality of evoked potentials comprises a signal amplitude (e.g. see [0090]).
Claim(s) 37 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dolev as applied to claim 31 above, and further in view of Javitt et al. (Pub. No.: US 2020/0107777 A1); hereinafter referred to as “Javitt”.
Regarding claims 37 and 48, Dolev discloses the claimed invention except for the functional brain network is a Default Mode Network (DMN). Javitt teaches that it is known to use such a modification as set forth in the abstract, [0010], [0023], and [0026] to provide targeting based upon specific features of brain organization for each individual, which produces more robust and consistent results (e.g. see [0035]). Javitt further teaches that electroconvulsive therapy (“ECT”) has been proven to be one of the most effective last resort procedures in many psychiatric disorders within clinical trials (see [0005]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to stimulate the DMN as taught by Javitt in the system/method of Dolev, since said modification would provide the predictable results of targeting based upon specific features of brain organization for each individual, which produces more robust and consistent results.
Claim(s) 39 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dolev as applied to claims 31 and 38 above, and further in view of Poltorak (Pub. No. US 2019/0082990 A1).
Regarding claims 39 and 50, Dolev discloses the claimed invention except for the non-invasive stimulation provided to the determined location of stimulation is combined with a different non-invasive stimulation, delivered sequentially or simultaneously, including transcranial electrical stimulation. Poltorak teaches that it is known to use such a modification as set forth in [0646] to provide non-invasive brain stimulation to improve various cognitive and affective functions (e.g. see [0171]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use combine TES with another type of stimulation as taught by Poltorak in the system/method of Dolev, since said modification would provide the predictable results of non-invasive brain stimulation to improve various cognitive and affective functions.
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 PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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