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. DETAILED ACTION Pursuant to the preliminary amendment dated 12/11/2023 , claim 11 is amended. No claims are newly added or canceled . Claims 1- 14 are pen ding in the instant application and are examined on the merits herein. Priority This application is a National Stage Application of PCT/ JP2022/028549 , filed on 7/15/2022 . The instant application claims foreign priority to JP 2021-117999, filed on 7/16/2021 and FR 2108969, filed on 8/27/2021 . Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified cop ies have been filed in the instant application on 12/11/2023 . Information Disclosure Statement The information disclosure statement s (IDS) dated 12/11/2023, 9/2/2025, 1/15/2026 and 1/20/2026 compl y with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the I DS documents ha ve been placed in the application file and the information therein has been considered as to the merits. C laim 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. Claim s 1-14 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Claims 1, 3-6, 11 and 14 contain numerous instances of the term “preferably”. The term " preferably " renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Preferences, options and examples are properly set forth in the specification, but when included in the claims lead to confusion over the intended scope of the claim. See MPEP § 2173.05(d). For examination purposes, the broadest claim limitation (s) will be considered without taking into account preferences or examples. 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 of this title, 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Claim s 1- 8, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US 8,444,562 B2, 2013, PTO-892) . Barthe et al. discloses a cosmetic, non-invasive method for reducing skin wrinkles by applying a coupling medium (e.g. coupling gel is used to couple probe to the patient's skin, where the gel can include medicines and other drugs) to the region of interest (ROI) on the skin then applying ultrasound treatment to the ROI , at a frequency of 2-25 MHz . ( Claims 15-20; Col. 8, Ln. 6-28; Col. 5, Ln 31-39; Col. 18, Ln.1-5 ) Barthe further discloses that: T he ultrasound transducer modules can be configured for a tissue depth of 1 mm, 1.5 mm, 2 mm, 3 mm, 4.5 mm, 6 mm, less than 3 mm, between 3 mm and 4.5 mm, more 10 than more than 4.5 mm, more than 6 mm, and anywhere in the ranges of 0-3 mm, 0-4.5 mm, 0-25 mm, 0-100 mm, and any depths therein (Col. 41, Ln. 8-13); T he ultrasound transducer can be configured with the ability to controllably produce conformal lesions of thermal injury in superficial human tissue within region of interest through precise spatial and temporal control of acoustic energy deposition...For example, spatial control may be realized through selection of the type of one or more transducer configurations insonifying region of interest 2106, selection of the placement and location of probe system 2104 for delivery of acoustical energy relative to region-of-interest 2106, e.g. probe system 2104 being configured for scanning over part or whole of region-of-interest 2106 to produce contiguous thermal injury having a particular orientation or otherwise change in distance from region-of-interest 2106, and/or control of other environment parameters, e.g., the temperature at the acoustic coupling interface can be controlled , and/or the coupling of probe 2104 to human tissue. (Col. 47, Ln. 1-21, emphasis added) The treatment employs a pulse duration of 0-60 milliseconds (e.g., about 20 milliseconds) and emits between about 1,000-5,000 W/cm2 (e.g., 2,500 W/cm2)…the energy flux is about 1.5-5.0 J/cm2. (Col. 42, Ln 32-36) Transducer 2404 may be composed of one or more individual transducers in any combination of focused, planar, or unfocused single-element, multi-element, or array transducers, including 1-D, 2-D, and annular arrays; linear, curvilinear, sector, or spherical arrays; spherically, cylindrically, and/or electronically focused, defocused, and/or lensed sources. (Col. 52, Ln. 4-9) There may be temperature increases within ROI which may range approximately from 0-60°. (Col. 33, Ln. 1-6) With reference to FIG. 8C, an transducer 19 may be controlled and operated in various manners by a hand-held format control system 92. An external battery charger 94 can be used with rechargeable-type batteries 96 or the batteries can be single-use disposable types, such as M-sized cells. Power converters 98 produce voltages suitable for powering a driver/feedback circuit 100 with tuning network 102 driving transducer 19 which is coupled to the patient via one or more acoustic coupling caps 104. Cap 104 can be composed of at least one of a solid media, semi-solid e.g. gelatinous media, and/or liquid media equivalent to an acoustic coupling agent (contained within a housing). Cap 104 is coupled to the patient with an acoustic coupling agent 106. In addition, a microcontroller and timing circuits 108 with associated software and algorithms provide control and user interfacing via a display 110, oscillator 112, and other input/output controls 114 such as switches and audio devices. (Col. 19, Ln. 29-45) Coupling system 2420 may facilitate such coupling through use of various coupling mediums, including air and other gases, water and other fluids, gels, solids, and/or any combination thereof, or any other medium that allows for signals to be transmitted between transducer active elements 2412 and a region of interest. In addition to providing a coupling function, in accordance with an embodiment, coupling system 2420 can also be configured for providing temperature control during the treatment application. For example, coupling system 2420 can be configured for controlled cooling of an interface surface or region between transducer probe 2400 and a region of interest and beyond by suitably controlling the temperature of the coupling medium. The suitable temperature for such coupling medium can be achieved in various manners, and utilize various feedback systems, such as thermocouples, thermistors or any other device or system configured for temperature measurement of a coupling medium. Such controlled cooling can be configured to further facilitate spatial and/or thermal energy control of transducer probe 2400. (Col. 50, Ln. 38-57) Barthe does not explicitly teach that the ultrasound waves penetrate to a maximum depth of 3 mm. Barthe also does not teach that the skin surface temperature is 50°C or lower. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of Barthe could be modified to configure the ultrasound transducer to emit energy to a maximum depth of 3 mm, thereby arriving at the instant invention. One would be motivated to modify Barthe in this manner because Barthe teaches that the ultrasound transducer modules can be configured for a tissue depth of 1-100 mm, or any depth therein, including less than 3 mm. It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of Barthe could be modified to have the skin surface temperature be 50°C or lower. Such a modification is obvious because Barthe teaches a skin temperature range of 0-60°C and teaches that the transducer is capable of being configured to provide temperature control, including cooling of the skin surface. Thus, in configuring the transducer to cool the skin surface with an explicitly taught range of 0-60°C, a cooled skin surface temperature of 50°C or lower is a prima facie obvious modification. With respect to the ranges of various claimed parameters, including ultrasound frequency, skin surface temperature, focal zone temperature, pulse energy, pulse duration and pulse power, the claimed ranges overlap those of the prior art. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) . (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) . (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) . With respect to claim s 13 and 14 claiming a kit, Barthe does not explicitly teach a kit. However, Figure 8C of Barthe depicts a complete system for carrying out the disclosed method, comprising an ultrasound transducer, a housing, a cap (i.e. head) and a coupling agent. One of ordinary skill in the art would recognize the system in Fig 8C as a kit suitable for performing the method of Barthe. Moreover, i t would have been further prima facie obvious to one of ordinary skill in the art to prepare a kit based on the prior art because the grouping together of various objects or compositions directed to a common purpose (i.e. forming a kit) when all the individual objects or compositions are prima facie obvious over the prior art does not make the kit patentable. The idea of preparing a kit based on a prima facie obvious composition flows logically from the perspective of providing organization, convenience and quality control . Accordingly, the instant claims are prima facie obvious over the teachings of the prior art. Claim s 9 -11 are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US 8,444,562 B2, 2013, PTO-892), in view of Vengerova et al. (RU 2218907 C1, 2003, PTO-892) . The disclosure of Barthe is referenced as discussed above. Barthe does not teach a coupling medium comprising hyaluronic acid, with the claimed amounts, molecular weight and dynamic viscosity values. Vengerova et al. discloses a ultrasound gel comprising hyaluronic acid at 0.01-2.5 wt%, with a molecular weight from 0.7-5 MDa . (pp. 2-3) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Barthe to use the ultrasound gel of Vengerova as the coupling medium, thereby arriving at the instant invention. Barthe does not direct one to any specific coupling medium. Thus, it is prima facie obvious for one to look to analogous art for guidance on art accepted ultrasound coupling media. Vengerova provides such guidance by disclosing a hyaluronic acid based gel that can be used as an ultrasound gel. Accordingly, the instant claims are prima facie obvious over the teachings of the prior art. Claim s 9, 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US 8,444,562 B2, 2013, PTO-892), in view of Du et al. ( CN 102580124 B , 20 1 3, PTO-892) . The disclosure of Barthe is referenced as discussed above. Barthe does not teach a coupling medium comprising hyaluronic acid, with the claimed amounts, molecular weight and dynamic viscosity values. Du et al. discloses a ultrasound gel comprising hyaluronic acid at 0.3-3 wt%, with a viscosity from 10000-16000 centipoise (a.k.a. 10-16 Pa•s) . ( Claim 2; Embodiments 15-20) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Barthe to use the ultrasound gel of Du as the coupling medium, thereby arriving at the instant invention. Barthe does not direct one to any specific coupling medium. Thus, it is prima facie obvious for one to look to analogous art for guidance on art accepted ultrasound coupling media. Du provides such guidance by disclosing a hyaluronic acid based gel that can be used as an ultrasound gel. Accordingly, the instant claims are prima facie obvious over the teachings of the prior art. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST. 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, Scarlett Goon can be reached on (571) 270-5341 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /DALE R MILLER/ Primary Examiner, Art Unit 1693