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 (IDS) submitted on 26 November 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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 4 is 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.
With regards to Claim 4, the claim recites “the sinusoidal wave”; however, such a limitation lacks antecedent basis and it is unclear if the sinusoidal wave refers to the “wave” recited in line 9 of Claim 1 or a different sinusoidal wave.
For the purposes of compact prosecution, the limitation will be interpreted as “the wave” which is . It should be noted that such an interpretation has not been evaluated for compliance with the written description requirement under 35 U.S.C. 112(a).
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 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.
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 recite2 similar limitations and are rejected under the same rationale as Claim 9.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lu et al. (US PGPUB 20170080259) – Harmonic superimposition.
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 9:00 am - 5:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith 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 M RAYMOND/Supervisory Patent Examiner, Art Unit 3798