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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tyler et al. (US 2016/0038770 A1) in view of Poltorak (US 2022/0273907 A1).
Regarding claim 1, Tyler et al. (‘770) teach a transcranial focused ultrasound acoustic pressure field device comprising: an input/output unit for allowing a user to input data, and outputting the data in a form that is recognizable by the user (see [0053], [0062], [0086], [0091]); a memory for storing a transcranial focused ultrasound acoustic pressure field program (see [0053], [0062], [0086], [0091]); and a control unit for executing the transcranial focused ultrasound acoustic pressure field program to derive result data according to the data input through the input/output unit (see [0053], [0062], [0086], [0091]), wherein the control unit outputs ultrasound acoustic pressure field data formed in a transcranial region by ultrasound applied by an ultrasonic transducer when shape data of a skull and position data of the ultrasonic transducer are input (see [0053], [0062], [0086], [0091], [0092]; and Figs. 5A-5D). Tyler et al. fails to explicitly teach a predictive device. However, Poltorak (‘907) from the same field of endeavor so teach a predictive device (see [0977], [1152], [1193], [1229]). It would be obvious to one of ordinary skill in the art to modify the invention of Tyler et al. with the features of Poltorak for the benefit of comparing different patient states for enhanced diagnostics and therapy.
Regarding claim 2, Tyler et al. (‘770) in view of Poltorak (‘907) teach the transcranial focused ultrasound acoustic pressure field prediction device of claim 1, wherein the control unit outputs the ultrasound acoustic pressure field data formed by the ultrasound applied by the ultrasonic transducer to the shape data of the skull by reflecting that refraction occurs as the ultrasound passes through the skull unit (see Tyler et al. [0053], [0062], [0086], [0091]).
Regarding claim 3, Tyler et al. (‘770) in view of Poltorak (‘907) teach the transcranial focused ultrasound acoustic pressure field prediction device of claim 2, wherein the position data of the ultrasonic transducer includes coordinate data representing three-dimensional coordinates at which the ultrasonic transducer is positioned with respect to the skull, and angle data representing an angle at which the ultrasonic transducer is positioned with respect to the skull (see Tyler et al. [0053], [0062], [0086], [0091], [0092]; and Figs. 5A-5D).
Regarding claim 4, Tyler et al. (‘770) in view of Poltorak (‘907) teach the transcranial focused ultrasound acoustic pressure field prediction device of claim 1, wherein the transcranial focused ultrasound acoustic pressure field prediction program is provided by artificial intelligence based on a deep neural network (DNN) (see Poltorak [0967]-[0978]).
Regarding claim 5, Tyler et al. (‘770) in view of Poltorak (‘907) teach the transcranial focused ultrasound acoustic pressure field prediction device of claim 4, wherein the transcranial focused ultrasound acoustic pressure field prediction program includes: an encoder for training a sparse matrix for the shape data of the skull, which is compressed; and a decoder for receiving the sparse matrix for the skull and the position data of the ultrasonic transducer, which is normalized, to generate an ultrasound acoustic pressure field in a region of interest corresponding to the received sparse matrix and the received position data (see Poltorak [0961], [1170]).
Regarding claim 6, Tyler et al. (‘770) in view of Poltorak (‘907) teach the transcranial focused ultrasound acoustic pressure field prediction device of claim 5, wherein the transcranial focused ultrasound acoustic pressure field prediction program is configured based on an autoencoder model based on a convolutional neural network (see Poltorak [0967]-[0978]).
Regarding claim 7, Tyler et al. (‘770) in view of Poltorak (‘907) teach the transcranial focused ultrasound acoustic pressure field prediction device of claim 5, wherein the transcranial focused ultrasound acoustic pressure field prediction program is configured based on a pix2pix model (see Poltorak [0967]-[0978]).
Regarding claim 8, Tyler et al. (‘770) in view of Poltorak (‘907) teach the transcranial focused ultrasound acoustic pressure field prediction device of claim 5, wherein the transcranial focused ultrasound acoustic pressure field prediction program is configured based on a variational autoencoder model (see Poltorak [0967]-[0978]).
Regarding claim 9, Tyler et al. (‘770) in view of Poltorak (‘907) teach the transcranial focused ultrasound acoustic pressure field prediction device of claim 4, wherein the artificial intelligence uses training data including the shape data of the skull, the position data of the ultrasonic transducer, and the ultrasound acoustic pressure field data to perform training so as to predict a shape of an ultrasound acoustic pressure field according to the shape data of the skull and the position data of the ultrasonic transducer by using the shape data of the skull and the position data of the ultrasonic transducer as inputs and using the ultrasound acoustic pressure field data corresponding to the inputs as an output (see Tyler et al. [0053], [0062], [0086], [0091], [0092]; and Figs. 5A-5D; and Poltorak [0967]-[0978]).
Regarding claim 13, Tyler et al. (‘770) in view of Poltorak (‘907) teach the device of claim 1, wherein the shape data of the skull comprises three-dimensional voxel data derived from a computed-tomography (CT) model of the skull including per-voxel acoustic property parameters selected from density, speed of sound, and attenuation (see Tyler et al. [0073]; and Poltorak [0180], [0187]-[0189]).
Regarding claims 10-12, the claims are rejected mutatis mutandis in view of the rejection of claims 1-4 and 9 above.
Response to Arguments
Applicant's arguments filed 11/11/2025 have been fully considered but they are not persuasive:
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.,”outputs a refraction-aware 3D acoustic pressure field in the brain as a function of (i) patient-specific skull shape data and (ii) transducer 3D pose.”) 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).
In response to applicant's argument that Tyler fails to teach “a controller that outputs predicted field data from input skull/pose” a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Furthermore, Applicant has applied a piecemeal analysis of the 103 rejection. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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 MARK REMALY whose telephone number is (571)270-1491. The examiner can normally be reached Mon - Fri 9:00 - 6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK D REMALY/Primary Examiner, Art Unit 3797
Prosecution Insights