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 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, 4-6, 8-11, 14-16 and 18-20 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.
Regarding claim 1, the claim limitation “...wherein the RF echo signals are processed without reconstructing a diagnostic ultrasound image” in lines 8-9 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 specification discloses ultrasound diagnostic images (see par. [0039], [0052], [0053] of the PG pub. version of the specification). The examiner notes that any negative limitation or exclusionary limitation must have basis in the original disclosure, and mere absence of a positive recitation is not basis for an exclusion.
Furthermore for claim 1, the claim limitation “wherein delivering FUS therapy to the patient outside of the MR environment comprises comparing a current acoustic signature obtained outside of the MR environment with the acoustic signature obtained during the mapping inside the MR environment to confirm that the FUS transducer or the array of FUS transducers is positioned relative to the patient in a same orientation as during the mapping” in lines 14-18 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 specification does disclose tracking phantom and transducer are tracked and recording acoustic signature consisted of pulse echo data, and comparing them with initial acoustic signature (see par. [0131] of the PG pub. version of the specification), but the specification does not explicitly disclose “wherein delivering FUS therapy to the patient outside of the MR environment comprises comparing a current acoustic signature obtained outside of the MR environment with the acoustic signature obtained during the mapping inside the MR environment to confirm that the FUS transducer or the array of FUS transducers is positioned relative to the patient in a same orientation as during the mapping”.
Regarding claim 11, the claim limitation “...wherein the RF echo signals are processed without reconstructing a diagnostic ultrasound image” in lines 10-11 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 specification discloses ultrasound diagnostic images (see par. [0039], [0052], [0053] of the PG pub. version of the specification). The examiner notes that any negative limitation or exclusionary limitation must have basis in the original disclosure, and mere absence of a positive recitation is not basis for an exclusion.
Furthermore for claim 11, the claim limitation “wherein delivering FUS therapy to the patient outside of the MR environment comprises comparing a current acoustic signature obtained outside of the MR environment with the acoustic signature obtained during the mapping inside the MR environment to confirm that the FUS transducer or the array of FUS transducers is positioned relative to the patient in a same orientation as during the mapping” in lines 13-16 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 specification does disclose tracking phantom and transducer are tracked and recording acoustic signature consisted of pulse echo data, and comparing them with initial acoustic signature (see par. [0131] of the PG pub. version of the specification), but the specification does not explicitly disclose “wherein delivering FUS therapy to the patient outside of the MR environment comprises comparing a current acoustic signature obtained outside of the MR environment with the acoustic signature obtained during the mapping inside the MR environment to confirm that the FUS transducer or the array of FUS transducers is positioned relative to the patient in a same orientation as during the mapping”.
Claims 4-6, 8-10, 14-16 and 18-20 are rejected as they depend from rejected claims 1 and 11.
Response to Arguments
Applicant’s arguments, pages 7-9, filed on 03/11/2026, with respect to prior art rejection have been fully considered and are persuasive. The previous prior art rejection has been withdrawn.
Furthermore on page 6-7 of Applicant’s arguments, the applicant states “the Examiner rejected claims 1 and 11 under 35 USC 112 (b), however, the previous Office action dated 01/07/2026 did not provide any rejection under 35 USC 112 (b).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Trahey et al. (US 2005/0215899) disclose method and system for acoustic radiation force impulses imaging of ablated tissue.
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 SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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