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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 17 is rejected because it is unclear what “a title of the helmet-type magnetic stimulating unit” is referring to.
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) 1-3, 7-9, 11 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0049387 to Saitoh et al. “Saitoh” in view of CN 110896610 to Cai et al. “Cai” or U.S. Publication No. 2019/0240499 to Leuze et al. “Leuze”.
As for Claim 1 and 19-20, Saitoh discloses an intracerebral stimulation system and method (Abstract) comprising a three dimensional camera unit (Paragraph [0125]) for capturing an image of a user, a data receiving part (e.g. processor) configured to receive a tomographic image (e.g. MRI, CT, PET) of the user’s head (Paragraphs [0036] and [0125]), a coil and coil drive device configured to apply stimulation to the brain of the patient (Paragraph [0134]). Examiner notes that collectively, the coil and coil drive unit would read on a magnetic field conversion module in its broadest reasonable interpretation. Saitoh also discloses determining a motor threshold for the user (Paragraphs [0037] and [0045]). Saitoh explains where patient targets are determined and positional information of the patient targets are combined with the patient’s head tomographic image data (three-dimensional coordinate data) and the camera photographs the patient targets and the coil targets fixed to the coil unit in order to display the position information in real time on a display (emphasis added-Paragraph [0131]). Such disclosures are considered to read on the claimed limitations of a location data calculating unit for mapping the camera image to a 3D medical image (e.g. MRI, CT, PET) including brain region information or to obtain a “mapped image” and calculating real time coordinates as location data to be stimulated from the mapped image in its broadest reasonable interpretation. Regarding the limitation of detecting a motor cortex and a location to be stimulated, Saitoh discloses stimulating a primary motor cortex (Paragraphs [0045], [0049]) and using a brain model created by three dimensional mapping software to display stimulation information including “positional information of targets” relative to the image data (e.g. three dimensional coordinate data; Paragraphs [0131] and [0136]). Saitoh discloses wherein the computing means displays a stimulation strength determined by a motor threshold (Paragraph [0136]).
While Saitoh’s stimulation targets displayed on image data that includes coordinates would appear to read on the limitation of detecting a motor cortex and calculating real time 3D coordinate data, it is not clear if the targets are represented as 3D coordinates.
Cai teaches from within a similar field of endeavor with respect to brain stimulation systems and methods (Abstract) wherein a 3D camera can collect head data of the patient and a computer models the patients head to determine stimulation target points (Abstract). Cai teaches where 3D coordinates (Page 4, Step S4).
Similarly, Leuze teaches from within a similar field of endeavor with respect to cranial therapy systems and methods (Abstract) where cranial therapy targets are determined according to coordinates of one or more brain structures in the patient coordinate system (Paragraphs [0026]-[0030] and [0034]).
Accordingly, one skilled in the art would have been motivated to have determined 3D coordinates of the stimulation targets (e.g. motor cortex) in the images provided by Saitoh as determined by Cai or Leuze in order to enhance the accuracy of the applied stimulation by applying real-time 3D coordinates specific to the user’s anatomy. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claim 2, Leuze discloses calibrating anatomical locations to the head coordinate system during an initial treatment session (Paragraph [0008]). Examiner notes that the coordinate system would include an origin (e.g. zero point).
With respect to Claim 3, Leuze discloses wherein facial landmarks and/or a facial point cloud is used to improve the targeting (Paragraphs [0004] and [0044]) via registration (Paragraphs [0023] and [0035]). Examiner notes that the registration process disclosed above would divide the image according to a resolution to the camera, detect a preset face protrusion (e.g. landmark) and determine an average value for the landmark in the point cloud (e.g. all the points being mesh data) in its broadest reasonable interpretation.
Regarding Claim 7, Saitoh discloses where the stimulation system sets drive conditions of the system (e.g. voltage, current and frequency applied to the coil) using the tomographic image and the 3D camera image (Paragraph [0125]) by determining positions of targets relative to the patient’s head (Paragraph [0131]). Cai uses a robot arm to facilitate positioning of the coil according to the determined targets. Accordingly, one skilled in the art would have been motivated to use a robot arm to position the stimulation coil in order to improve the accuracy of stimulation.
As for Claim 8, Cai’s robotic system includes a multi-joint robot with a controller configured to move the coil to the target point (Abstract; Fig. 1 and corresponding descriptions). Such disclosure is considered to read on an RC controller in its broadest reasonable interpretation.
As for Claim 9, Examiner notes that the coordinate system used to position the robot as described above would include a zero point in order to determine appropriate movement information to the desired target in its broadest reasonable interpretation.
Regarding Claim 11, Saitoh explains where movement information from an optimum simulation position is displayed (Paragraph [0040]). Examiner notes that one skilled in the art would have been motivated to control the robot’s movements to reach the optimum position in any way (e.g. circular movement, linear movement, etc.) as a matter of pure design choice.
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saitoh and Leuze/Cai as applied to claim 1 above, and further in view of CN 111477299 to Zhao et al. “Zhao”.
Regarding Claims 4-6, Saitoh and Leuze/Cai disclose a stimulating system and method as described above but do not expressly disclose utilizing artificial intelligence.
Zhao teaches from within a similar field of endeavor with respect to neural treatment systems and methos (Abstract) where artificial intelligence on a cloud computing platform (Page 3, paragraph “3”) is used by the system to improve treatment (Page 6, “Paragraph H”; Page 17 in the translation provide by Examiner).
Accordingly, one skilled in the art would have been motivated to have used artificial intelligence as described by Zhao in order to enhance treatment parameters (e.g. target selection).
Regarding Claim 10, Zhao discloses wherein the stimulation can be part of a cognitive behavior psychotherapy system running a test with the therapy (Pages 4 and 10).
Claim(s) 7-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saitoh and Leuze as applied to claim 1 above, and further in view of Cai.
Regarding Claim 7, Saitoh and Leuze disclose a stimulating device as described above. Saitoh discloses where the stimulation system sets drive conditions of the system (e.g. voltage, current and frequency applied to the coil) using the tomographic image and the 3D camera image (Paragraph [0125]) by determining positions of targets relative to the patient’s head (Paragraph [0131]).
However, Saitoh and Leuze do not expressly disclose use of a robot to position the stimulation means.
Cai uses a robot arm to facilitate positioning of the coil according to the determined targets (Abstract; Fig. 1 and corresponding descriptions).
Accordingly, one skilled in the art would have been motivated to use a robot arm to position the stimulation coil in order to improve the accuracy of stimulation. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claim 8, Cai’s robotic system includes a multi-joint robot with a controller configured to move the coil to the target point (Abstract; Fig. 1 and corresponding descriptions). Such disclosure is considered to read on an RC controller in its broadest reasonable interpretation.
As for Claim 9, Examiner notes that the coordinate system used to position the robot as described above would include a zero point in order to determine appropriate movement information to the desired target in its broadest reasonable interpretation.
Regarding Claim 11, Saitoh explains where movement information from an optimum simulation position is displayed (Paragraph [0040]). Examiner notes that one skilled in the art would have been motivated to control the robot’s movements to reach the optimum position in any way (e.g. circular movement, linear movement, etc.) as a matter of pure design choice.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saitoh, Leuze and Cai as applied to claim 7 above, and further in view of Zhang.
As for Claim 10, Saitoh, Leuze and Cai disclose a stimulating system and method as described above but do not expressly disclose performing cognitive training during treatment as claimed.
Zhao teaches from within a similar field of endeavor with respect to neural treatment systems and methos (Abstract) where stimulation can be part of a cognitive behavior psychotherapy system running a test with the therapy (Pages 4 and 10).
Accordingly, one skilled in the art would have been motivated to have included the cognitive testing system described by Zhao in order to confirm if the treatment was successful with respect to cognitive testing. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saitoh and Leuze/Cai as applied to claim 1 above, and further in view of U.S. Publication No. 2018/0071545 to Saitoh et al. “Saitoh 2”.
As for Claim 12, Saitoh and Leuze/Cai disclose a stimulating system and method as described above but do not depict a helmet type stimulating unit as claimed.
Saitoh 2 teaches from within a similar field of endeavor with respect to stimulation systems and methods where a helmet-type positioning system is used to house stimulation coils (Paragraph [0269]).
Accordingly, one skilled in the art would have been motivated to have used a helmet-type unit as described by Saitoh 2 in order to enhance patient comfort during stimulating. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claim 13, Saitoh 2 uses a localization mark on the casing 9 to facilitate positioning (Paragraph [0144]).
Regarding Claim 14, Saitoh 2 uses switches to turn coils on/off (Paragraph [0149]).
With respect to Claim 15, Saitoh 2 discloses wherein a figure eight shaped coil may be used (Paragraphs [0016] and [0024]).
Allowable Subject Matter
Claims 16-18 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Examiner notes that the prior art of record fails to disclose all the limitations of Claims 16-18 in combination with the brain stimulating device as claimed in Claims 1, 12 and 13.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive. Updated grounds of rejection necessitated by amendment.
As for the 35 U.S.C. 112(b) rejection of Claim 17, Examiner respectfully notes that Applicant has failed to specifically address this rejection. Thus, it has been maintained.
Regarding the prior art rejections, Applicant argues the combination of references fails to disclose real time MT measurements and immediate therapeutic feedback loop (REMARKS, Pages 12-13). Examiner respectfully notes the claims fail to disclose an immediate therapeutic feedback loop and thus, Applicant’s argument are not commensurate with the scope of the claims. Thus, the rejections have been maintained.
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 CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797