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 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.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liston (US 2020/0289044 A1).
With respect to claim 1, Liston discloses a system comprising (see system in Figure 1 provided herein): a computing device including a processor programmed to (see processor #102): receive magnetic resonance imaging (MRI) data of a brain of the subject (see paragraph 0036); determine, using the MRI data, functional connectivity of the brain between a voxel in a subcortical region of the brain and a voxel in a cortical region of the brain (see paragraphs 0004, 0060-0061 and 0066;
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also, the voxel in the region is described in paragraph 0066 as functional volume of the fMRI data since it is known that functional volume data is made of voxels); identify a target location in the brain to be targeted by neuromodulation based on the determined functional connectivity to achieve a clinical outcome (see paragraphs 0040 and 0089 disclosing the use of rTMS neurostimulator targeting the location dorsomedial prefrontal cortex identified by depression biotype using a classification module #104 as seen on Figure 1 for said identification); and a display configured to display a report indicating the target location (see paragraph 0055 discussing the use of a display with the device shown).
With respect to claims 2 and 16, Liston discloses the processor is further programmed to determine the functional connectivity of the brain by determining a temporal correlation of a neurophysiological index (see paragraph 0059 discussing the BOLD signal reflecting a function of neural activity, blood flow, and changes in blood volume in the brain wherein as neurons are stimulated in the brain, oxygenated blood flow increases, implying low frequency fluctuations of blood flow and oxygenation, in the activated region hence showing fluctuations throughout different regions considered as the claimed neurophysiological index defined in the Specification of the current application in paragraph 0056 as low frequency fluctuations of blood flow and oxygenation, measured in different brain areas).
With respect to claim 3, Liston discloses the processor is further programmed to determine functional connectivity of the brain between the voxel in the subcortical region and each cortical functional network in a plurality of cortical functional networks (see paragraphs 0004, 0060-0061 and 0066; also, the voxel in the region is described in paragraph 0066 as functional volume of the fMRI data since it is known that functional volume data is made of voxels).
With respect to claim 4, Liston discloses the processor is further programmed to identify a winning functional network among the plurality of cortical functional networks as a functional network having the highest functional connectivity with the voxel to identify the target location (see paragraphs 0040 and 0089 disclosing the use of rTMS neurostimulator targeting the location dorsomedial prefrontal cortex identified by depression biotype using a classification module #104 as seen on Figure 1 for said identification wherein the classification module #104 generates the highest biotype likelihood score based on the extracted brain region functional connectivity according to paragraphs 0014, 0069 and 0089).
With respect to claim 5, Liston discloses the target location is in an integrative zone, and wherein the processor is further programmed to integrate the voxel in the integrative zone when functional connectivity between the voxel and one or more functional networks is above a threshold (see paragraphs 0014, 0040, 0069 and 0089).
With respect to claim 6, Liston discloses one or more functional networks are among a remaining of the plurality of cortical functional networks minus the winning functional network (see paragraphs 0004, 0060-0061 and 0066).
With respect to claim 7, Liston discloses the processor is further programmed to identify a given subcortical region as an integrative zone if a correlation between the given subcortical region and one or more functional networks other than the winning functional network is greater than a predetermined threshold (see paragraphs 0004, 0060-0061 and 0066).
With respect to claim 8, Liston discloses the threshold is 66 percent (see paragraph 0105).
With respect to claim 9, Liston discloses the magnetic resonance data includes at least one of functional magnetic resonance imaging (fMRI) data or resting state (rs) fMRI data of the subject (see paragraphs 0035-0036).
With respect to claim 10, Liston discloses the processor is further programmed to acquire fMRI data as task fMRI data of the subject and determine functional connectivity based on the rs-fMRI data (see paragraphs 0035-0036 and 0057).
With respect to claim 11, Liston discloses the processor is further programmed to identify at least one of an activation region and a deactivation region based on the acquired task fMRI data to derive a task fMRI map and validate the identified target location using the derived task fMRI map (see paragraphs 0035-0037 and 0057).
With respect to claim 12, Liston discloses the processor is further programmed to determine functional connectivity by determining functional connectivity between the voxel in the subcortical region and a region of interest (ROI) in the cortical region (see paragraphs 0004, 0060-0061 and 0066).
With respect to claim 13, Liston discloses the processor is further programmed to determine functional connectivity by calculating timing of the functional connectivity between the voxel in a subcortical region and the voxel in the cortical region based on the magnetic resonance data (see paragraphs 0035, 0060 and 0066).
With respect to claim 14, Liston discloses the processor is further programmed to identify the target location by identifying a voxel having an abnormal timing compared to a healthy individual as the target location (Abstract and paragraphs 0035, 0060 and 0066).
With respect to claim 15, Liston discloses the processor is further configured to determine functional connectivity of the brain between the voxel in the subcortical region of the brain and a vertex in a cortical functional network (see paragraphs 0004, 0060-0061 and 0066) by assessing includes blood oxygenation level dependent (BOLD) (see paragraphs 0037-0038) activity time-course data from each vertex in the cortical functional network and determining functional connectivity further comprises (Abstract and paragraphs 0035, 0060 and 0066): averaging the BOLD activity time-course data of the cortical functional network across all vertices in the cortical functional network; extracting BOLD activity time-course data from the voxel in the subcortical region; and determining functional connectivity as a correlation between the BOLD activity time-course data of the voxel in the subcortical region and the BOLD activity time-course data of the cortical functional network (see paragraphs 0045-0046, 0059-0061, 0064-0066 and 0109).
With respect to claim 17, Liston discloses the neurophysiological index is a measure of low frequency fluctuations of blood flow or oxygenation measured across a plurality of regions in the brain (see paragraph 0059 discussing the BOLD signal reflecting a function of neural activity, blood flow, and changes in blood volume in the brain wherein as neurons are stimulated in the brain, oxygenated blood flow increases, implying low frequency fluctuations of blood flow and oxygenation, in the activated region hence showing fluctuations throughout different regions considered as the claimed neurophysiological index defined in the Specification of the current application in paragraph 0056 as low frequency fluctuations of blood flow and oxygenation, measured in different brain areas).
Response to Arguments
Applicant’s arguments, see pages 4-16, filed 07/13/26, with respect to claims 1-17 in conjunction with the Terminal Disclaimer filed have been fully considered and are persuasive. The claim objection, the 35 U.S.C 101 and Double Patenting Rejections for claims 1-17 have been withdrawn.
It is noted that applicant did not address the 35 U.S.C. 102(a)(1) rejection as stated on Office Action filed 01/14/26, Therefore, the office takes the position that the applicant agrees with the rejection above.
Conclusion
THIS ACTION IS MADE FINAL. 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 DIXOMARA VARGAS whose telephone number is (571)272-2252. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Raymond Keith can be reached at 571-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIXOMARA VARGAS/Primary Examiner, Art Unit 3798
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