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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 07/21/2025 is acknowledged.
Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/21/2025.
Claim Objections
Claims 5, 7, 11, and 12 are objected to because of the following informalities:
Claims 5 and 7 recite the limitation “the central region”, however, no central region has been set forth previously. The limitation should read –a central region— for purposes of proper antecedent basis.
Claim 11 recites the limitation “the patient’s abdomen”, however, no patient has been recited previously. The limitation should read –a patient’s abdomen— for purposes of proper antecedent basis.
Claim 12 recites the limitation “the patient’s skull”, however, no patient has been recited previously. The limitation should read –a patient’s skull— for purposes of proper antecedent basis.
Appropriate correction is required.
Claim Interpretation
Claim 7 recites the limitation “to accommodate an imaging probe disposed within the central region”. The limitation is directed to an intended use of the claimed device, where limitations directed towards intended use must result in a structural difference between the claimed invention and the prior art. In this case, it is noted that the prior art must merely be capable of accommodating an imaging probe disposed within the central region in order to read on the claimed invention as the imaging probe is not recited as part of the claimed invention but rather intended to be used with the claimed invention (i.e. the array comprising a scaffold, a plurality of transducer elements, and an opening in the scaffold).
Claim Rejections - 35 USC § 112
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.
Claims 1-13 are 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.
Claim 1 recites the limitation “the ultrasound transducer array”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the limitation is referring to the histotripsy transducer array or is attempting to define a different/distinct transducer array (e.g. defined by the plurality of transducer elements or other elements). For examination purposes, it has been interpreted to mean any ultrasound transducer array, however, clarification is required.
Claim 1 recites the limitation “a plurality of transducer elements arranged on the scaffold such that the ultrasound transducer array has a packing density greater than or equal to 90%”. The limitation is unclear as to what is meant by the packing density being greater than or equal to 90% as there is no clear reference as to what elements are referred to for the packing density and how the packing density relates to a percentage value. For examination purposes, it has been interpreted that any transducer array/elements thereof are considered to have a packing density greater than or equal to 90% with reference to the array/elements themselves.
Claim 1 recites the limitation “the array”. It is unclear if the limitation is referring to the histotripsy transducer array or the ultrasound transducer array. For examination purposes, it has been interpreted to mean any of the previously recited arrays, however, clarification is required.
The term “generally rectangular” in claim 3 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Examiner notes that it is unclear what shape is considered to be generally rectangular or to what degree a shape must be rectangular to be considered generally rectangular. For examination purposes, it has been interpreted to mean any rectangular features would constitute being generally rectangular, however, clarification is required.
Claim 6 recites the limitation “the transducer elements in the one or more peripheral regions”. There is insufficient antecedent basis for this limitation in the claim. In this case, claim 6 depends from claim 1 which merely recites “a plurality of transducer elements arranged on the scaffold”, but does not define “transducer elements in one or more peripheral regions”. It is unclear if the claim is attempting to define a subset of the plurality of transducer elements or if the claim is attempting to further define that the plurality of transducer elements are in one or more peripheral regions. For examination purposes, it has been interpreted to mean any one transducer elements in any one or more peripheral regions.
Claim 11 recites the limitation “scaffold includes a geometry optimized for transmission of ultrasound waves into a target tissue within the patient’s abdomen”. The term “optimized” is a relative term which renders the claim indefinite. The term “optimized” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, it is noted that optimized is relative such that it is not clear what geometry constitutes being optimized for such transmission. For examination purposes, it has been interpreted to mean that any geometry which may be used for transmission of ultrasound waves into a target tissue within the patient’s abdomen is considered to be a geometry optimized for such transmission, however, clarification is required.
Claim 12 recites the limitation “scaffold includes a geometry optimized for transmission of ultrasound waves into a target tissue within the patient’s skull”. The term “optimized” is a relative term which renders the claim indefinite. The term “optimized” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, it is noted that optimized is relative such that it is not clear what geometry constitutes being optimized for such transmission. For examination purposes, it has been interpreted to mean that any geometry which may be used for transmission of ultrasound waves into a target tissue within the patient’s skull is considered to be a geometry optimized for such transmission, however, clarification is required.
Claims 11 and 12 recite the limitation “a target tissue”. It is unclear if the target tissue is the same as the previously recited target tissue or if this is a different target tissue. For examination purposes, it has been interpreted to mean any target tissue, however, clarification is required.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qiao et al. (US 20200037990 A1), hereinafter Qiao.
Regarding claim 1,
Qiao discloses a histotripsy transducer array (at least figs. 4a-4c and 5a-5b (200) and corresponding disclosure in at least [0050] or at least fig. 2 (102/104) and corresponding disclosure in at least [0045]), comprising:
A scaffold (at least fig. 5a-5b (208) and corresponding disclosure in at least [0052]. See also fig. 2 depicting HIFU transducer arrays 102 and 104 which as disclosed in [0050] may be modular and may comprise a number of sub-arrays or modules formed as a separate transducer unit 200, thus the arrays 102 and 104 include a scaffold including a number of housings 208);
A plurality of transducer elements (at least fig. 4a-4c (206) and corresponding disclosure in at least [0051]) arranged on the scaffold such that the ultrasound transducer array has a packing density greater than or equal to 90% (see at least figs. 4a-4c depicting a packing density greater than or equal to 90% in its broadest reasonable interpretation), wherein the array is configured to transmit histotripsy pulses at an amplitude exceeding a cavitation threshold of one or more bubble cloud locations in a target tissue ([0045] which discloses In other embodiments the system may be used to achieve ablation, histotripsy or lithotripsy in the kidney, liver or pancreas through the ribcage and [0073] which discloses during treatment the focus may be moved by varying the relative timing at different points in the NP. The resulting cavitation and fragmentation of the NP may be imaged in real time and [0042] which discloses [0046] A passive cavitation detector (PCD) 114 may be provided, for example at the centre of one of the transducers 102 and arranged coaxially with the transducer, and may be arranged to detect ultrasound radiation generated by cavitation induced in an object in the target region 106. Examiner notes that histotripsy is used to generate bubble clouds, thus disclosure that the system is used for histotripsy means that pulses transmitted exceed the cavitation threshold at bubble cloud locations in the target tissue)
Regarding claim 2,
Qiao further discloses wherein the scaffold is concave (see at least figs. 5a and 6a)
Regarding claim 3,
Qiao further discloses wherein the scaffold is generally rectangular (see at least figs. 5a and 6d)
Regarding claim 4,
Qiao further discloses wherein some of the plurality of transducer elements are arranged within a central region of the scaffold in a plurality of concentric rows of transducer elements (see at least fig. 4a depicting some of the plurality of transducers arranged within a central region in a plurality of concentric rows)
Regarding claim 5,
Qiao further discloses wherein some of the plurality of transducer elements are arranged in one or more peripheral regions of the scaffold adjacent to the central region (see at least fig. 4a depicting some of the plurality of transducer elements arranged in one or more peripheral regions).
Regarding claim 6,
Qiao further discloses wherein the transducer elements in the one or more peripheral regions are arranged in arced rows of transducer elements (see at least fig. 4a depicting transducer elements in one or more peripheral regions and in combination with fig. 5a which depicts an arced housing (208) means the rows are arced rows of transducer elements).
Regarding claim 7,
Qiao further discloses further comprising an opening in the scaffold to accommodate an imaging probe disposed within the central region (see at least fig. 2 depicting an opening in the transducer 102/104) and thus in the scaffold thereof to accommodate an imaging probe (114/116) disposed within the central region).
Regarding claim 8,
Qiao further discloses wherein the plurality of transducer elements have the same surface area (see at least figs. 4a-4b depicting a same surface area of the transducer elements)
Regarding claim 11,
Qiao further discloses wherein the scaffold includes a geometry optimized for transmission of ultrasound waves into a target tissue within the patient’s abdomen ([0063] which discloses similar process could be followed to identify optimal acoustic windows and array configurations for sound transmission through the ribcage, illustrated in FIG. 14 See also [0065] disclosing the effect of different configurations of transducer array were investigated in the simulation by defining different shaped transducer arrays and optimizing the position of each of them to cover the acoustic windows).
Regarding claim 12,
Qiao further discloses wherein the scaffold includes a geometry optimized for transmission of ultrasound waves into a target tissue within the patient’s skull ([0041] FIG. 15 shows a possible positioning of the configurable transducer array of FIG. 13 for imaging or treatment the brain of a patient through the skull and [0063] which discloses a similar process could be followed to identify optimal acoustic windows and array configurations for sound transmission through the ribcage, illustrated in FIG. 14, or the skull, shown in FIG. 15. See also [0065] disclosing the effect of different configurations of transducer array were investigated in the simulation by defining different shaped transducer arrays and optimizing the position of each of them to cover the acoustic windows).
Claims 1 (alternatively), 12 (alternatively), and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hall et al. (US 20130289593 A1), hereinafter Hall.
Regarding claim 1 (alternatively),
Hall discloses a histotripsy transducer array (at least figs. 8-9 and corresponding disclosure in at least [0082]-[0083]), comprising: A scaffold (at least fig. 8A (820) and corresponding disclosure in at least [0082] and/or figs. 9A-9B (920) and corresponding disclosure in at least [0083]); and a plurality of transducer elements (at least fig. 8A (834] and corresponding disclosure in at least [0082] and/or figs. 9A-9B (918) and corresponding disclosure in at least [0083]) arranged on the scaffold such that the ultrasound transducer array has a packing density greater than or equal to 90% (see at least figs. 8A and 9A depicting transducers in modular transducer elements housing 834 matching sockets in the scaffold as disclosed in [0082] thus considered to have a packing density greater than or equal to 90%), wherein the array is configured to transmit histotripsy pulses at an amplitude exceeding a cavitation threshold of one or more bubble cloud locations in a target tissue ([0066] which discloses this disclosure can describe therapy systems that use Histotripsy therapy to generate lesions through rib or bone aberrators without applying any correction mechanisms other than transducer power modulation to compensate for attenuation effects. The ultrasound therapy systems can be configured to generate Histotripsy pulses to deliver Histotripsy therapy to tissue. Histotripsy uses controlled cavitation bubble clouds to induce mechanical tissue fractionation. [0067] which discloses the tissue fractionation effect from Histotripsy therapy occurs when the focal pressure exceeds a certain threshold level at which a cavitation bubble cloud is initiated).
Regarding claim 12,
Hall further discloses wherein the scaffold includes a geometry optimized for transmission of ultrasound waves into a target tissue within the patient’s skull (see at least fig. 8A-8B depicting a hemispherical scaffold, thus is considered to be optimized for transmission of the ultrasound waves into a target tissue within the patient’s skull)
Regarding claim 13,
Hall further discloses wherein the scaffold is hemispherical (see at least figs. 8a-8b).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Qiao in view of Kushculey et al. (US 20090230823 A1), hereinafter Kushculey.
Regarding claim 9,
Qiao teaches the elements of claim 1 as previously stated. Qiao fails to explicitly teach wherein the plurality of transducer elements have varying surface areas.
Kushculey, in a similar field of endeavor involving ultrasound transducers, teaches an ultrasound treatment array comprising:
A scaffold (see fig. 3B and [0121] which discloses a piece of ceramic as the base)
And a plurality of transducer elements having vary surface areas ([0121] which discloses a elements of different size and [0031] which discloses at least one of said conductive layers being a segmented layer comprising a plurality of electrode elements, each of said electrode elements defining a segmental transducer; exciting at least some of said electrode elements with high frequency voltages such that their associated segmental transducers emit ultrasound energy)
been obvious to a person having ordinary skill in the art before the effective filing date to have modified Qiao to include transducer elements having varying surface areas as taught by Kushculey in order to provide a desired therapeutic effect. Furthermore, such modification amounts to merely an obvious design choice yielding predictable results with respect to ultrasonic treatment (MPEP 2144), such a design choice conclusion is supported by the teachings of Kushculey which provides alternative transducer element designs which provide desired effects of ultrasound treatment.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Qiao in view of Foreign Chaggares et al. (TW 201729929 A), hereinafter Chaggares. Examiner notes that citations to Chaggares are with reference to the translated copy provided herein.
Regarding claim 10,
Qiao teaches the elements of claim 1 as previously stated. Qiao fails to explicitly teach wherein the plurality of transducer elements are separated by a layer of epoxy less than or equal to 125 microns thick.
Chaggares, in a similar field of endeavor involving ultrasound transducers, teaches wherein a plurality of transducer elements are separated by a layer of epoxy (pg. 3 which discloses the gaps between transducer elements and in further slit slots are filled with a suitable acoustic soft material, such as a soft epoxy using vacuum pressure impregnation techniques) less than or equal to 125 microns thick (pg. 2 which discloses a typical component spacing is between 38-45 microns for a 40 MHz transducer and 25-30 microns for a 60 MHz transducer)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Qiao to include a layer of epoxy as taught by Chaggares in order to provide improved mechanisms for joining leads or traces to individual transducers for providing an array of high-frequency transducer elements (Chaggares pg. 2). Furthermore, such a modification amounts to merely combining prior art elements according to known techniques yielding predictable results with respect to ultrasound transducer manufacturing, thus rendering the claim obvious (MPEP 2143).
Claim 13 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Qiao in view of Hall.
Regarding claim 13 (alternatively),
Qiao teaches the elements of claim 12 as previously stated. Qiao further teaches wherein the scaffold is part-spherical ([0011]), however, fails to explicitly teach wherein the scaffold is hemi-spherical.
Hall, in a similar field of endeavor involving histotripsy transducer arrays, teaches a scaffold is hemispherical (see at least figs. 8a-8b).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Qiao to include a hemispherical scaffold as taught by Hall in order to provide a larger range of transducers (i.e. transducers which may extend further around the patient’s anatomy). Furthermore, such a modification amounts to merely a simple substitution of one known scaffold shape for another yielding predictable results with respect to histotripsy transducer designs thereby rendering the claim obvious (MPEP 2143).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/BROOKE LYN KLEIN/Examiner, Art Unit 3797