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
This Office Action is in response to Applicants’ Amendment and Remarks filed on 7/1/2026 in which claims 2, 7 and 9 are cancelled and claims 1, 3-6, 11 and 14 are amended. No claims are newly added.
Claims 1, 3-6, 8 and 10-14 are pending 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 copies have been filed in the instant application on 12/11/2023.
Withdrawn Rejections
All rejection(s) of record for claim(s) 2, 7 and 9 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot.
Applicant’s amendment, filed on 7/1/2026, with respect to the rejection of claims 1, 3-6, 8 and 10-14 under 35 U.S.C. 112(b), has been fully considered and is persuasive. Applicant has amended the claims to remove “preferably”. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 7/1/2026 with respect to the rejection of claims 1, 3-6, 8, 13 and 14 under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US 8,444,562 B2, 2013), has been fully considered and is persuasive. Barthe does not teach a coupling medium comprising any of the claimed active agents. The rejection is hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) or modified rejections necessitated by Applicants' amendment, filed on 7/1/2026, wherein instant independent claims 1 is amended to alter the breadth and scope of the claim, wherein the remaining pending claims depend from said independent claims. Therefore, rejections from the previous Office Action have been modified.
Modified Rejections
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.
Claims 1, 3-6, 8-11, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US 8,444,562 B2, 2013, reference of record), in view of Vengerova et al. (RU 2218907 C1, 2003, reference of record).
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:
The 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);
The 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. Barthe does not teach a coupling medium comprising hyaluronic acid, with the claimed amounts, molecular weight and dynamic viscosity values.
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 claims 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, it 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.
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.
Response to Arguments
Applicants’ response with respect to the rejection over Barthe/Vengarova, has been fully considered but is not persuasive.
Applicant argues that the prior art is directed to a method of causing thermal injury to underlying skin and subcutaneous fat, whereas the instant method is directed to delivery of active agents to an optimal penetration depth below the skin surface. Hence, the application of Barthe/Vengarova as prior art is improper. Applicants’ argument is not persuasive because the instant claims are directed to a method of reducing wrinkles and the method of Barthe/Vengarova is also directed to reducing wrinkles. Because the ultrasound parameters of Barthe/Vengarova overlap those of the instant claims and both methods are directed to the same purpose, the instant claims are rendered obvious by Barthe/Vengarova. The instant claims specify parameters such as “focal zone of a maximum depth of 3mm” or “pulse duration of 150 ms or less”, however, there is nothing unexpected demonstrated for these parameters, thus because those values are within the ranges taught by Barthe/Vengarova, they are considered an obvious variant of the teachings of the prior art.
Applicant further argues that the instant method achieves a mild skin surface temperature increase to 50°C or less, which is in contrast to the method of Barthe/Vengarova where thermal injury occurs. Applicants’ argument is not persuasive because: 1) There are no temperature parameters present in the independent claim and 2) Even for dependent claims containing temperature ranges of 45-65°C, these claims are obvious over Barthe/Vengarova because the range of the prior art is 0-60°C which overlaps the claimed range.
Applicant further argues that one would not look to the secondary references for guidance on the use of hyaluronic acid in a coupling medium because the secondary references only teach a general ultrasound gel whereas the instant method is specific to the use of a hyaluronic acid based medium with specific viscosity and molecular weight for the intended purpose. Applicants’ argument is not persuasive because: 1) The independent claim does not limit the active agents in the medium to only hyaluronic acid, thus the independent claim does not dictate that hyaluronic acid is required for any particular effect and 2) For claims the do limit the active agent to hyaluronic acid, there is nothing demonstrating any unexpected effect for the claimed medium, thus the use of any ultrasound medium, including those taught by the secondary references, would be expected to be functionally equivalent for the purpose of being suitable for application to the skin and capable of conducting ultrasonic waves.
The rejection is still deemed proper and is maintained.
Claims 1, 3-6, 8-10 and 12-14 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, 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:
The 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);
The 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. Barthe does not teach a coupling medium comprising hyaluronic acid, with the claimed amounts, molecular weight and dynamic viscosity values.
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 claims 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, it 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.
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.
Response to Arguments
With respect to the rejection over Barthe/Du, Applicants' arguments and the response to them, are referenced as detailed above for the rejection over Barthe/Vengarova.
The rejection is still deemed proper and is maintained.
Conclusion
No claims are allowed.
Applicants' amendment necessitated the new and/or modified 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 mailing date of this final action.
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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.
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.
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/DALE R MILLER/ Primary Examiner, Art Unit 1693
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