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 .
Information Disclosure Statement
The information disclosure statements filed 11 June 2026, 31 July 20216, 4 August 2026, & 5 August 2026 fail to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Applicant is directed to the Information Disclosure Statement (IDS) size fee Quick Reference Guide which addresses the new requirements for the IDS size fee and size fee assertion, how applicants/patent owners should count references, what happens if the fee isn’t paid, and examples <https://www.uspto.gov/sites/default/files/documents/quick-reference-guide-to-the-information-disclosure-statement-ids.pdf>.
Response to Amendment
The rejection under 35 U.S.C. 112(b) has been withdrawn in light of the amendment to the claims filed on 1 July 2026.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8, 10-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vortman et al. (US PGPUB 20210077834; hereinafter "Vortman") in further view of Azhari et al. (US PGPUB 20100274161; hereinafter "Azhari") .
With regards to Claim 1, a method for sharpening a focal volume of a therapeutic system or an imaging system (focusing transducer elements of various groups having different frequency, phase, and/or amplitude such that the focal lengths correspond to the target region; see Vortman ¶ [0041]), the method comprising:
applying an array to a target, the array including a plurality of transducers (ultrasound transducer 108 that is geometrically shaped and physically positioned relative to the patient 106 in order to focus the ultrasonic energy beam 102 at a three-dimensional focal zone located within the targeted volume 104; see Vortman ¶ [0034]);
selecting a group of frequencies, the group of frequencies including a plurality of unique frequencies (group the transducer elements 110 into multiple groups 132, wherein each group 134,136 are separably controllable to emit ultrasound waves at frequencies, amplitudes and/or phases that are independent {i.e. unique} of the frequencies, amplitudes and/or phases of the other groups 132; see Vortman ¶ [0037 & 0041]);
assigning one of the frequencies in the group of frequencies to two or more of the plurality of transducers (group the transducer elements 110 into multiple groups 132, wherein each group 134,136 are separably controllable {i.e. assigning frequencies} to emit ultrasound waves at frequencies, amplitudes and/or phases that are independent of the frequencies, amplitudes and/or phases of the other groups 132; see Vortman ¶ [0037 & 0041]);
driving the plurality of transducers to generate a plurality of beamlets, each beamlet including a wave of one of the frequencies in the group of frequencies (the transducer may then substantially simultaneously, sequentially or cyclically direct ultrasound waves having different frequencies {i.e. beamlets} to different regions of the target); and
emitting the plurality of beamlets toward the target thereby generating a field of reduced focal volume, wherein the focal volume is improved multifold (controller 124 activating transducer elements according to the treatment plan with corresponding frequencies, amplitudes and/or phases; see Vortman ¶ [0044]).
While Vortman discloses mechanical steering in at least one direction {i.e. effectively moving the transducers of the array} (see Vortman ¶ [0049]), it appears that Vortman may be silent to a plurality of arrays. However, Azhari teaches of an ultrasound system 120 for lipolysis and body contouring including first and second phased array transducers for steering a focal zone to a target region to apply a frequency range of 100-250khz (see Azhari ¶ [0031 & 0109-0110]), wherein a first subset of acoustic elements 30 and a second subset of transducer elements 32 {i.e. plurality of transducer arrays} are arranged opposite one another such that the treatment focus zone is disposed between said subsets (see Azhari FIG. 12B & ¶ [0283]).
Vortman and Azhari are both considered to be analogous to the claimed invention because they are in the same field of . Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vortman to incorporate the above teachings of Azhari to provide at least a plurality of arrays. Doing so would aid in accelerating the tissue damaging procedure and reducing the overall treatment time. (see Azhari ¶ [0280]).
Claims 6, 10, & 15 recite similar limitations and are rejected under the same rationale as Claim 1.
With regards to Claim 21, wherein the group of frequencies are based on a frequency bandwidth of the system (A wide bandwidth is particularly preferred in ultrasound treatment applications because it offers a large range of frequencies that may be optimized for different depths in tissue, facilitating treatment at different target regions; see Vortman ¶ [0005]).
Claim 11 recites similar limitations and are rejected under the same rationale as Claim 2.
With regards to Claim 31, wherein the transducers are of arbitrary dimensions, based on dimension constraints of the system (the transducer 108 includes a large number of transducer elements 110 arranged in a one-, two- or three-dimensional array or other regular manner, or in a random fashion {i.e. arbitrary dimension}; see Vortman ¶ [0035]).
Claim 12 recites similar limitations and are rejected under the same rationale as Claim 3.
With regards to Claim 41, wherein the system is an ultrasound system, and wherein the sinusoidal wave is an ultrasound wave (transducer 108 is an ultrasound transducer; see entirety of Vortman disclosure).
Claim 13 recites similar limitations and are rejected under the same rationale as Claim 4.
With regards to Claim 51, wherein all of the plurality of transducers are assigned one of the frequencies in the group of frequencies (FIG. 1B of Vortman clearly illustrates each of the transducer elements 110 of the multiple groups 132 being assigned a frequency corresponding to their group; see also Vortman ¶ [0037]).
Claim 14 recites similar limitations and are rejected under the same rationale as Claim 5.
With regards to Claim 71, wherein each array in the plurality of arrays includes at least 3 transducers (FIG. 1B of Vortman clearly illustrates at least 3 transducers 110).
Claim 16 recites similar limitations and are rejected under the same rationale as Claim 7.
With regards to Claim 81, wherein the group of frequencies are equally spaced between a bandwidth of the transducers (FIG. 1B of Vortman clearly illustrates equally spaced groups 1-5).
Claim 17 recites similar limitations and are rejected under the same rationale as Claim 8.
With regards to Claim 191, wherein emitting the plurality of beamlets toward the target thereby generates a field of reduced focal volume through multifrequency superposition of the plurality of beamlets (with reference to FIG. 2A, the target volume 104 may be divided into multiple regions; the transducer may then substantially simultaneously {i.e. superposition}, sequentially or cyclically direct ultrasound waves having different frequencies to different regions of the target; see Vortman ¶ [0039]).
Claim 20 recites similar limitations and are rejected under the same rationale as Claim 19.
Claims 9 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Vortman in view of Azhari as applied to claim 1 above, and further in view of Agarwal et al. (US PGPUB 20230330443 having an effective filing date of 10 February 2022; hereinafter "Agarwal") .
With regards to Claim 91, while modified Vortman teaches of an operating frequency range of 100-250khz, as detailed above, it appears that modified Vortman may be silent to wherein the group of frequencies are in a range of 500 kHz to 800 kHz. However, of sonodynamic therapy system which drives a first and a second signal to generate respective acoustic ensonification drive patterns with varying phase, frequency, and amplitude (see Agarwal Abstract). In particular, Agarwal teaches that the transducers can be driven in a range of including 500 kHz, 550 kHz, 600 kHz, 650 kHz, 700 kHz, 750 kHz, 800 kHz (see Agarwal ¶ [0287]).
Modified Vortman and Agarwal are both considered to be analogous to the claimed invention because they are in the same field of . Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Vortman to incorporate the above teachings of Agarwal to provide at least a range of 500 kHz to 800 kHz. Doing so would aid in focus[ing] energy in a smaller therapeutic operating field (see Agarwal ¶ [0290]).
Claim 18 recite similar limitations and are rejected under the same rationale as Claim 9.
Response to Arguments
Applicant's arguments filed 1 July 2026 have been fully considered but they are not persuasive.
In particular, Applicant argues that Vortman in combination of Azhari fails to teach of "emitting the plurality of beamlets toward the target thereby generating a field of reduced focal volume" as recited in Claim 1. Applicant argues that ‘Vortman's objective is to optimize ultrasound treatment by selecting different frequencies for different target regions, target depths, or treatment characteristics. Although Vortman discloses operating different groups of transducers at different frequencies, Vortman fails to disclose or suggest generating and emitting a plurality of beamlets, wherein each beamlet includes a wave of "one of the frequencies in the group of frequencies," and that the emitted beamlets generate a field having a reduced focal volume. Moreover, Vortman wholly fails to recognize reducing focal volume as an objective or describe any improvement in focal volume resulting from the selected frequencies.” The Office respectfully disagrees. Since the instant specification fails to provide a special definition for “beamlet” and beamlet is not a term of art, it is afforded its plain and ordinary meaning. Therefore, each transducer element 110 of Vortman which is utilized to generate the beamformed ultrasound waves generates its own beamlet. Since Votman discloses, as cited, that the each transducer and/or group of transducers are independently controlled via frequency, amplitude, and phase, resultant ultrasound wave at said frequency amounts to a beamlet. Further, FIG. 5B of Vortman clearly illustrates beamforming as described in ¶ [0049] such that “the control facility 114 may drive the transducer elements 110 to generate an ultrasound beam 512 focused at the target volume 104,” wherein the focusing acts to reduce the focal volume. For at least these reasons, Applicant’s arguments are not persuasive.
With regards to independent Claim 10, applicant relies on the same rationale to argue that said independent claims distinguish from the cited prior art. Accordingly, said argument is not persuasive for at least the same reasons as Claim 1 as detailed above.
With regards to dependent claims, Applicant relies on the virtue of their dependency upon abovementioned independent claims to argue novelty. Accordingly, said argument is not persuasive for at least the same reasons as Claims 1 and 10 as detailed above.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571)272-6402. The examiner can normally be reached M-F 8:00 am - 4:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith M. Raymond can be reached on (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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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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