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 .
Claim Objections
Claims 32-34 and 40 are objected to because of the following informalities: In claims 32-34 and 40, --the step of-- should be added after the term “wherein” in line 1. Appropriate correction is required.
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) 31-36, 38, 41-47, 49, and 52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dolev et al. (Pub. No.: US 2018/0008827 A1); hereinafter referred to as “Dolev”.
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: sequentially stimulating each of a plurality of locations within a brain region of the subject (e.g. Fig. 4 and see [0072], [0079], [0086]-[0090]), the brain region forming a node of a functional brain network of connected nodes in the brain of the subject (e.g. see [0072], [0079], [0086]-[0090]); sensing a plurality of evoked potentials in response to sequentially 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 [0072]-[0073], [0086]-[0098]).
Regarding claims 32 and 43, Dolev discloses 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 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 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 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 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.
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 brain region is a node of 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.
Claim(s) 40 and 51 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 Geva et al. (Pub. No.: US 2017/0216595 A1); hereinafter referred to as “Geva”.
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 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.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792