CTFR 18/555,683 CTFR 95056 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. Response to Arguments New 112(a) rejections necessitated by amendment. Regarding 35 U.S.C. 112(b) Examiner notes that the previously set forth 112(b) rejections are withdrawn in view of the amendments to the claims, however, new 112(b) rejections are necessitated by amendment. Regarding prior art 07-37 AIA Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive. For example, applicant argues with respect to the scaffold has an arbitrary irregular shape specifically designed to match an acoustic window of a target tissue that “Qiao and Hall are completely silent with respect to these features” and “Qiao and Hall are not concerned with the specific problem addressed by the present invention, as discussed above. Instead Qiao and Hall are instead primary concerned with the problem of achieving sufficiently high intensities, by tight packing of array elements. Neither Qiao nor Hall teach irregularly shaped transducer arrays specifically designed to match an acoustic window of a target” (REMARKs pg. 6). Examiner respectfully disagrees in that Qiao explicitly teaches in [0019] providing a modular transducer array configurable into a plurality of different configurations, identifying one of the configurations as best matching the shape of the acoustic window, configuring the transducer array in said one of the configurations, and transmitting ultrasound to the target location using the transducer array and Hall explicitly teaches in [0054] The acoustic lens and housing shell can be made into any arbitrary geometry and dimension. They can first be designed in a 3D computer aided design (CAD) software such as SolidWorks, TurboCAD and in [0057] which discloses rapid-prototyping allows complex shapes that cannot be produced with subtractive or formative methods. For specific clinical applications, a complex shape aperture may be desired to either fit a particular acoustic window or to obtain a particular focal pattern. Using a rapid-prototyping method, any arbitrary geometry can be designed and constructed, which is not possible with existing subtractive (e.g., machining) or formative (e.g., injection molding) methods. Applicant’s arguments against the teachings of Qiao and Hall are thus not found persuasive as both Qiao and Hall are explicitly directed to scaffolds which are arbitrary irregular shapes designed to match an acoustic window . 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. 07-31-01 Claim 13 is 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. Claim 13 recites the limitation “wherein the scaffold is hemispherical”. Examiner notes that claim 1 previously recites that the scaffold has an arbitrary irregular shape specifically designed to match an acoustic window. Examiner notes that there does not appear to be sufficient written description for a scaffold which has an arbitrary irregular shape specifically designed to match an acoustic window and is also hemispherical. For example, [0148] of applicant’s originally filed specification appears to disclose the use of a hemispherical array transducer for transcranial use and [0041] discloses in some examples, the scaffold is hemispherical, however, such disclosure is not tied to disclosure regarding the arbitrary irregular shape such as that disclosed in [0093] and [0096]. Therefore, it is noted that applicant’s originally filed specification does not provide sufficient support for a scaffold that is both arbitrarily and irregularly shaped and hemispherical, thus the limitation constitutes new matter such that a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing. Claim Rejections - 35 USC § 112(b) 07-30-02 AIA 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. 07-34-01 Claims 1-13 and 20 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 “a scaffold having an arbitrary irregular shape specifically designed to match an acoustic window of a target tissue”. The limitation is first unclear because irregular is a relative term and it is unclear what shapes are considered “regular” and how the recited shape differs from such a regular shape such that it is considered irregular. The limitation is further unclear as it recites an arbitrary irregular shape designed to match an acoustic window. The limitation appears to contradict itself by reciting an arbitrary irregular shape and then further reciting that it is designed to match an acoustic window of a target tissue. Such designing of the scaffold to match an acoustic window would appear to be based on reason/rule which would differ from an arbitrary shape. It is therefore unclear how the arbitrary irregular shape is specifically designed to match an acoustic window of a target tissue. For examination purposes, it has been interpreted that the scaffold has a shape designed to match an acoustic window, however, clarification is required. Claim 13 recites the limitation “wherein the scaffold is hemispherical”. The limitation appears to contradict the language of claim 1 which recites that the scaffold has an arbitrary irregular shape. It is therefore unclear how the scaffold is both an arbitrary irregular shape and is hemispherical as hemispherical corresponds with exactly half of a sphere. For examination purposes, it has been interpreted that the scaffold may be a shape designed to match an acoustic window and/or is hemispherical, however, clarification is required. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 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 figs. 2 and 13-14 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) having an arbitrary irregular shape specifically designed to match an acoustic window of a target tissue ([0019] which discloses providing a modular transducer array configurable into a plurality of different configurations, identifying one of the configurations as best matching the shape of the acoustic window, configuring the transducer array in said one of the configurations, and transmitting ultrasound to the target location using the transducer array); A plurality of transducer elements (at least fig. 4a-4c (206) and corresponding disclosure in at least [0051]) arranged on the scaffold such that a surface area of the plurality of transducer elements has a packing density greater than or equal to 90% of a surface area of the scaffold (see at least figs. 4a-4c depicting a surface area of the plurality of transducer elements encompasses the entire surface area of the scaffold 200/208, thus has a packing density greater than or equal to 90% of a surface area of the scaffold), wherein the histotripsy transducer array is configured to transmit histotripsy pulses at an amplitude exceeding a cavitation threshold of one or more bubble cloud locations in the 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 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 and an imaging probe (at least fig. 2 (114/116) and corresponding disclosure in at least [0046] disposed within the opening (see at least fig. 2). 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 20, Claim 20 recites the limitation “wherein the scaffold is designed by projecting rays from points in a 3D model of the target tissue to identify the acoustic window for the target tissue without blockage from bones or gassy organs” which represents a product-by-process limitation; therefore, the claim is not limited to the recited step of designing by projecting rays from points in a 3D model of the target tissue to identify the acoustic window for the target tissue without blockage from bones or gassy organs, but rather to the structure resulting from the step. It is noted that the result of the projecting of rays from points in the 3D model of the target tissue is merely a scaffold having a shape which matches the acoustic window this feature is explicitly taught by Qiao in at least [0019]. Additionally/alternatively, Qiao further discloses wherein the scaffold is designed by projecting rays from points in a 3D model of the target tissue (see at least fig. 11 and corresponding disclosure in at least [0063]) to identify the acoustic window for the target tissue without blockage from bones or gassy organs ([0063] which discloses the locations and shapes of the acoustic windows, i.e. the areas of the curved surface over which the maximum acoustic power from the point source is received, was calculated. Two appropriate acoustic windows, one on either flank of the patient, were identified, in this case by overlapping the outputs of the ultrasound propagation and ray tracing models as shown in FIG. 12. Examiner first notes that by identifying acoustic windows using maximum acoustic power form the point source would be without blockage from bones or gassy organs. Additionally/alternatively, it is noted that “to identify the acoustic window for the target tissue without blockage from bones or gassy organs” is considered an intended use of the projecting rays, where it is noted that the projection of rays of Qiao would be capable of being used to identify the acoustic window for the target tissue without blockage from bones or gassy organs) . 07-15 AIA Claim s 1 (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]) having an arbitrary irregular shape specifically designed to match an acoustic window of a target tissue ([0054] which discloses the acoustic lens and housing shell can be made into any arbitrary geometry and dimension and [0057] which discloses a complex shape aperture may be desired to either fit a particular acoustic window or to obtain a particular focal pattern. Using a rapid-prototyping method, any arbitrary geometry can be designed and constructed, which is not possible with existing subtractive (e.g., machining) or formative (e.g., injection molding) methods.); 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 a surface area of the plurality of transducer elements has a packing density greater than or equal to 90% of a surface area of the scaffold (see at least figs. 4a-4f as well as 8A and [0086] which discloses [0086] To maximize the use of surface area, elements of shapes other than circular shape can be used. For example, square, rectangular, and hexagon can be used maximize the usage of surface area and is particularly helpful in constructing compact transducers with high pressure output), 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 13, Hall further discloses wherein the scaffold is hemispherical (see at least figs. 8a-8b) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-aia AIA 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) 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 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 . 07-21-aia AIA 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) . 07-21-aia AIA Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Qiao in view of Hall . Regarding claim 13, 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 having an arbitrary irregular shape specifically designed ([0054] which discloses the acoustic lens and housing shell can be made into any arbitrary geometry and dimension) to match an acoustic window of a target tissue, wherein the scaffold is hemispherical (see at least figs. 8a-8b and [0057] which discloses Rapid-prototyping allows complex shapes that cannot be produced with subtractive or formative methods. For specific clinical applications, a complex shape aperture may be desired to either fit a particular acoustic window or to obtain a particular focal pattern. Using a rapid-prototyping method, any arbitrary geometry can be designed and constructed, which is not possible with existing subtractive (e.g., machining) or formative (e.g., injection molding) methods.). 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 07-40 AIA 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 BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4. 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, Anne Kozak can be reached at 5712700552. 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. /BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797 Application/Control Number: 18/555,683 Page 2 Art Unit: 3797 Application/Control Number: 18/555,683 Page 3 Art Unit: 3797 Application/Control Number: 18/555,683 Page 4 Art Unit: 3797 Application/Control Number: 18/555,683 Page 5 Art Unit: 3797 Application/Control Number: 18/555,683 Page 6 Art Unit: 3797 Application/Control Number: 18/555,683 Page 7 Art Unit: 3797 Application/Control Number: 18/555,683 Page 8 Art Unit: 3797 Application/Control Number: 18/555,683 Page 9 Art Unit: 3797 Application/Control Number: 18/555,683 Page 10 Art Unit: 3797 Application/Control Number: 18/555,683 Page 11 Art Unit: 3797 Application/Control Number: 18/555,683 Page 12 Art Unit: 3797 Application/Control Number: 18/555,683 Page 13 Art Unit: 3797 Application/Control Number: 18/555,683 Page 14 Art Unit: 3797 Application/Control Number: 18/555,683 Page 15 Art Unit: 3797
Prosecution Insights