CTFR 17/642,284 CTFR 82051 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-29-01 AIA Claim 1 is objected to because of the following informalities: the term “an” should be added after the term “including” in line 1 . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1, 5, 12, 22, 23, 28-30, 33, 34, 40, 44, and 100-102 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally filed specification fails to provide support for a controller configured to receive intrabodily pressure (IBP) data and data associated with ultrasound waves, wherein the controller is configured to correlate the IBP data with transmitted and/or received ultrasound waves to generate a diagnosis based on the correlated IBP data and the transmitted and/or received ultrasound waves. There is no discussion in the specification as to how IBP data and transmitted and/or received ultrasound waves are correlated to generate a diagnosis. The specification does not provide an adequate written description that reasonably conveys to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, was in possession of the claimed invention. Examiner’s Note The following is a statement of reasons for the lack of prior art rejections: The closest prior art all teach correlating transmitted and/or received ultrasound waves to IBP/ICP (intracranial pressure) values; data associated with ultrasound waves is used to determine IBP/ICP. None of the prior art discloses or suggests, either alone or in combination, a system comprising a controller configured to receive IBP data and data associated with ultrasound waves, wherein the controller is further configured to generate a diagnosis based on correlating the IBP data with transmitted and/or received ultrasound waves , in combination with the other claimed elements. Response to Arguments Applicant's arguments filed 14 April 2026 have been fully considered. While amendments made to the claims have overcome the previous rejections under 35 U.S.C. 112(b), as discussed in paragraph 4 above, they have warranted a new rejection under 35 U.S.C. 112(a). Applicant’s arguments regarding the rejections of the claims in view of the previously cited prior art are persuasive. However, the claims are not in condition for allowance due to the rejection under 35 U.S.C. 112(a). Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sampath et al.’239 (WO 2018/064239 – previously cited) in view of Hu et al.’103 (US Pub No. 2015/0297103 – previously cited) further in view of Fishman’929 (US Pub No. 2017/0329929), as discussed in paragraph 8 of the Non-Final Rejection mailed out 15 January 2026, is the closest prior art of record. Tyler’869 (US Pub No. 2012/0289869 – previously cited) teaches using known focusing elements, such as an acoustic hyperlens or an acoustic metamaterial, to focus or direct ultrasound saves to one or more brain regions (sections [0050], [0067], and [0122]). Grunwald et al.’675 (US Pub No. 2009/0005675 – previously cited) teaches using a diverging lens to shape an ultrasound signal produced by an ultrasound transducer (section [0110]). Gordon et al.’640 (US Pub No. 2018/0055640 – previously cited) teaches a cranial implant comprising a sonolucent material forming at least one lens element (sections [0049-0051]). Lal et al.’381 (US Pub No. 2014/0355381 – previously cited) teaches the use of acoustic metamaterials to guide sonic signals, the acoustic metamaterials acting as an acoustic waveguide to promote more efficient transmission of acoustic waves from one point to another (section [0141]). Tyler’441 (US Pub No. 2011/0178441 – previously cited) teaches using a material having a negative refractive index to focus ultrasound waves used to modulate cellular activity (section [0083]). Willis et al.’375 (US Pub No. 2005/0203375 – previously cited) teaches using a diverging lens with an ultrasound transducer (sections [0094] and [0105]). Witte et al.’147 (US Pub No. 2013/0039147 – previously cited) teaches using two lenses, one converging lens and one diverging lens, to focus ultrasound waves at a desired depth in tissue (section [0107]). Davoyan et al.’124 (US Pub No. 2019/0260124 – previously cited) teaches engineering acoustic metasurfaces with subwavelength microstructures to achieve effective acoustic parameters for an ultrasound transducer (sections [0076-0077]). 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 ETSUB D BERHANU whose telephone number is (571)270-5410. The examiner can normally be reached Mon-Fri 9:00am-5:30pm EST. 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, Jennifer Robertson can be reached at (571) 272-5001. 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. /ETSUB D BERHANU/Primary Examiner, Art Unit 3791 Application/Control Number: 17/642,284 Page 2 Art Unit: 3791 Application/Control Number: 17/642,284 Page 3 Art Unit: 3791 Application/Control Number: 17/642,284 Page 4 Art Unit: 3791 Application/Control Number: 17/642,284 Page 5 Art Unit: 3791 Application/Control Number: 17/642,284 Page 6 Art Unit: 3791
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