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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 30, 2026 has been entered.
This Office action is responsive to an amendment filed January 30, 2026. Claims 2-30 are pending. Claim 1 has been canceled. Claims 2 & 15 have been amended. New claims 29-30 have been added.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 30, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 29 is objected to because of the following informalities:
At line 2, the limitations “configures” should apparently read --configured--.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2-10, 15-21, 23-27 & 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US 2012/0271294) (“Barthe” hereinafter) in view of Domankevitz (US 2016/0310212) further in view of Hissong et al. (US 6,595,934) (“Hissong” hereinafter).
In regards to claim 2, Barthe discloses an applicator for applying ultrasound energy to a skin tissue volume, comprising:
an array (48, 148, 248, 2714) comprising a plurality of ultrasound transducers (19, 119, 219, 2404, 3104), said transducers (19, 119, 219, 2404, 3104) arranged side by side, said transducers (19, 119, 219, 2404, 3104) configured to (collectively) emit unfocused ultrasound energy with selected skin treatment parameters suitable to thermally damage at least a portion of at least one deep skin tissue volume (see at least fig. 31 and par 0250 & 0290-0292), wherein each of said ultrasound transducers (19, 119, 219, 2404, 3104) is configured to generate, by said emitted unfocused ultrasound energy, thermal damage lesion in said at least one deep skin tissue volume extending into a fat tissue layer located deeper than a dermis layer from a surface of a skin (see at least fig. 5 and par 0250);
a cooling module configured to apply cooling to a surface of the skin contacting said array (48, 148, 248, 2714) directly or indirectly to reduce thermal damage to said skin surface (see at least fig. 35 and par 0135, 0187, 0240, 0275, 0281& 0286-0287)
wherein heating of said at least one deep skin tissue volume by said emitted unfocused ultrasound energy, and said cooling, are provided with parameter values selected to obtain said separate vertically elongated thermal damage lesion (see at least fig. 38 and par 0273) generated by each of said transducers (19, 119, 219, 2404, 3104) (see at least fig. 35 and par 0135, 0187, 0240, 0275, 0281& 0286-0287), at a selected depth starting at a distance of 0.5 mm from tissue surface (see at least par 0250).
Barthe discloses an applicator, as described above, that fails to explicitly teach an applicator with said transducers configured to emit unfocused ultrasound energy with selected skin treatment parameters suitable to thermally damage at least a portion of a deep skin tissue volume.
However, Domankevitz teaches that it is known to provide an applicator 30 with said transducers 34 configured to each emit unfocused ultrasound energy suitable to
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thermally damage at least a portion of said tissue volume (see at least abstract, fig. 3 and par 0022, 0024, 0039 & 0043).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the applicator of Barthe with said transducers configured to emit unfocused ultrasound energy suitable to thermally damage at least a portion of said tissue volume, each of said transducers comprising a first surface which is configured to indirectly contact said surface of said tissue volume and provide said thermal coupling and a second surface spaced apart from said first surface as taught by Domankevitz since such a modification would amount to applying a known technique (i.e., as taught by Domankevitz) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as treating tissue at a region of interests using unfocused ultrasound containing at least one of muscle, tendon, ligament or cartilage (MTLC) tissue to achieve a therapeutic effect (see at least par 0024 of Domankevitz)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Barthe as modified by Domankevitz discloses an applicator, as described above, that fails to explicitly teach an applicator wherein each of said ultrasound transducers is configured to generate a separate vertically elongated thermal damage lesion.
However, Hissong teaches that it is known to provide an applicator wherein each of said ultrasound transducers (18, 28, 428) is configured to generate a separate thermal damage lesion (see at least figs. 1-4; col. 5, lines 15-45, col. 6, lines 24-34 & col. 13, lines 5-22).
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Therefore, since Barthe discloses an applicator wherein only pockets of fat are removed or otherwise ablated, coagulated or treated such that other surrounding tissue is untreated (see figs. 10A-B and par 0147-0148) and lesions of various sizes and shapes may be produced to facilitate various types of treatment methods (see at least fig. 38 and par 0273), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the applicator of Barthe as modified by Domankevitz wherein each of said ultrasound transducers is configured to generate a separate vertically elongated thermal damage lesion as taught by Hissong since such a modification would amount to applying a known technique (i.e., as taught by Hissong) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as creating discontinuous or non-contacting individual lesions to selectively treat or ablate only pockets of fat--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 3, Barthe discloses an applicator according to claim 2, wherein said unfocused ultrasound energy generated with said selected skin treatment parameters is effective to target fibrotic tissue in said fat tissue layer while having low or no effect on fat tissue in said fat tissue layer (see at least par 0262).
In regards to claim 4, Barthe discloses an applicator according to claim 3, wherein said fibrotic tissue comprises collagen (see at least par 0262).
In regards to claim 5, Barthe discloses an applicator according to claim 3, wherein said ultrasound transducers (19, 119, 219, 2404, 3104) heat said fibrotic tissue in said thermal damage lesion to a temperature of 60 degrees Celsius, which is between 50-80 degrees Celsius (see at least par 0262).
In regards to claim 6, Barthe discloses an applicator according to claim 2, wherein said array (48, 148, 248, 2714) of ultrasound transducers (19, 119, 219, 2404, 3104) is shaped and sized to generate by said emitted energy multiple spaced-apart vertically elongated thermal damage lesions extending into said fat tissue layer separated by non- damaged tissue (see at least fig. 38 and par 0273).
In regards to claim 7, Barthe discloses an applicator according to claim 6, wherein said multiple spaced-apart vertically elongated thermal damage lesions 27 have an elongated substantially elliptical cross-section (see at least figs. 5 & 38).
In regards to claim 8, Barthe discloses an applicator according to claim 2, wherein said ultrasound transducers (19, 119, 219, 2404, 3104) are configured to generate said vertically elongated thermal damage lesions in skin tissue layers deeper than a dermis (see at least fig. 5 and par 0250 & 0262).
In regards to claim 9, Barthe discloses an applicator according to claim 2, wherein said ultrasound transducers (19, 119, 219, 2404, 3104) are configured to generate vertically elongated thermal damage lesions (see at least fig. 38 and par 0273) in skin tissue layers located at a depth of 0.5-5 mm from the epidermis (see at least par 0250).
In regards to claim 10, Barthe discloses an applicator according to claim 2, wherein each of said ultrasound transducers (19, 119, 219, 2404, 3104) comprise an elongated piezo element (see at least linear arrays 2710, 2712 from fig. 31 and par 0290-0292).
In regards to claim 15, Barthe discloses a method for treating skin, comprising:
contacting a skin surface with an array (48, 148, 248, 2714) of spaced-apart ultrasound transducers (19, 119, 219, 2404, 3104) (see at least figs. 26A, 31 & 35);
emitting unfocused ultrasound energy from two or more of said spaced-apart ultrasound transducers (19, 119, 219, 2404, 3104) with parameters suitable to (collectively) generate a separate vertically elongated thermal damage lesion (27, 3404, 3408) (see at least fig. 38 and par 0273) by unfocused ultrasound energy emitted by said two or more of said spaced-apart ultrasound transducers (19, 119, 219, 2404, 3104) in deep tissue layers of the skin which extends into a fat tissue layer located deeper than a dermis layer of the skin (see at least figs. 10A-B & 31 and par 0147-0148, 0250, 0273 & 0290-0292);
cooling said skin surface during said contacting to reduce thermal damage to said skin surface (see at least figs. 35 & 38 and par 0135, 0187, 0240, 0275, 0281, 0286-0287 & 0300);
wherein said emitted unfocused ultrasound energy, and said cooling are provided with parameter values selected to obtain said separate vertically elongated thermal damage lesion (see at least fig. 38 and par 0273) generated by each of said transducers (19, 119, 219, 2404, 3104) (see at least figs. 35 & 38 and par 0135, 0187, 0240, 0275, 0281, 0286-0287 & 0300), at a selected depth starting at a distance of 0.5 mm from said skin surface (see at least par 0250).
Barthe discloses a method, as described above, that fails to explicitly teach a method comprising emitting unfocused ultrasound energy from each of said two or more of said spaced-apart ultrasound transducers.
However, Domankevitz teaches that it is known to provide a method comprising emitting unfocused ultrasound energy from each of said two or more of said spaced-apart ultrasound transducers 34 (see at least abstract, fig. 3 and par 0022, 0024, 0039 & 0043).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Barthe comprising emitting unfocused ultrasound energy from each of said two or more of said spaced-apart ultrasound transducers as taught by Domankevitz since such a modification would amount to applying a known technique (i.e., as taught by Domankevitz) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as treating tissue at a region of interests using unfocused ultrasound containing at least one of muscle, tendon, ligament or cartilage (MTLC) tissue to achieve a therapeutic effect (see at least par 0024 of Domankevitz)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Barthe as modified by Domankevitz discloses a method, as described above, that fails to explicitly teach a method comprising emitting unfocused ultrasound energy from each of two or more of said spaced-apart ultrasound transducers with parameters suitable to generate at least one vertically elongated thermal damage lesion by said emitted unfocused ultrasound energy in deep tissue layers of the skin which extends into a fat tissue layer located deeper than a dermis layer of the skin.
However, Hissong teaches that it is known to provide a method comprising emitting unfocused ultrasound energy from each of two or more of said spaced-apart ultrasound transducers with parameters suitable to generate at least one vertically elongated thermal damage lesion by said emitted unfocused ultrasound energy (see at least figs. 1-4; col. 5, lines 15-45, col. 6, lines 24-34 & col. 13, lines 5-22).
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Therefore, since Barthe discloses an applicator wherein only pockets of fat are removed or otherwise ablated, coagulated or treated such that other surrounding tissue is untreated (see figs. 10A-B and par 0147-0148) and lesions of various sizes and shapes may be produced to facilitate various types of treatment methods (see at least par 0273), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Barthe as modified by Domankevitz comprising emitting unfocused ultrasound energy from each of two or more of said spaced-apart ultrasound transducers with parameters suitable to generate at least one vertically elongated thermal damage lesion by said emitted unfocused ultrasound energy, as taught by Hissong, in deep tissue layers of the skin which extends into a fat tissue layer located deeper than a dermis layer of the skin , as taught by Barthe, since such a modification would amount to applying a known technique (i.e., as taught by Hissong) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as creating discontinuous or non-contacting individual lesions to selectively treat or ablate only pockets of fat--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 16, Barthe discloses a method according to claim 15, comprising: targeting fibrotic tissue in said fat tissue layer by said emitted unfocused ultrasound energy while having low or no effect on fat tissue in said fat tissue layer (see at least par 0262).
In regards to claim 17, Barthe discloses a method according to claim 16, wherein said fibrotic tissue comprises collagen (see at least par 0262).
In regards to claim 18, Barthe discloses a method according to claim 16, wherein said emitting comprises heating said fibrotic tissue in said fat tissue layer by said unfocused ultrasound energy to a temperature between 50-80 degrees C (see at least par 0203, 0217, 0263 & 0311).
In regards to claim 19, Barthe discloses a method according to claim 15, wherein parameters of said unfocused ultrasound energy are selected to generate vertically elongated thermal damage lesions (see fig. 38 and par 0273) in a layer at a depth of 0.5-5 mm from said skin surface (see at least par 0250).
In regards to claim 20, Barthe discloses a method according to claim 15, comprising producing by said emitted unfocused ultrasound energy separate vertically elongated thermal damage lesions (see fig. 38 and par 0273) extending into said fat tissue layer (see at least par 0250), wherein said produced vertically elongated thermal damage lesions have an elongated substantially elliptical cross-section (see at least figs. 5 & 38 and par 0273).
In regards to claim 21, Barthe discloses a method according to claim 15, comprising maintaining said skin surface in a temperature between 5-40 degrees C by said cooling and during said contacting (see at least par 0109, 0162 & 0209).
In regards to claim 23, Barthe discloses a method according to claim 15, comprising producing a short-term effect visible at 1 hour or earlier (i.e., in real-time) following said emitting by said unfocused ultrasound energy, and wherein a duration of said emitting is selected to produce said short-term effect (see at least par 0029, 0034, 0038 & 0243).
In regards to claim 24, Barthe as modified by Domankevitz and Hissong discloses a method according to claim 15, as described above, that fails to explicitly teach a method comprising producing a long term cosmetic effect visible after 3 weeks or more following said emitting by said unfocused ultrasound energy. However, since Barthe teaches that a method comprising producing bioeffects that may take place either instantly over longer time periods (see at least par 0104, 0165 & 0203), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Barthe as modified by Domankevitz and Hissong comprising producing a long term cosmetic effect visible after 3 weeks or more following said emitting by said unfocused ultrasound energy as claimed in order to produce bioeffects that may take place over longer time periods.
In regards to claim 25, Barthe discloses a method according to claim 15 wherein said fat tissue layer comprises a hypodermis layer (see at least par 0091).
In regards to claim 26, Barthe as modified by Hissong discloses an applicator, as described above, that fails to explicitly teach a method wherein said spaced-apart ultrasound transducers are planar ultrasound transducers. However, Domankevitz teaches that it is known to provide an applicator wherein said spaced-apart ultrasound transducers 34 are planar ultrasound transducers 34 (see at least abstract, fig. 3 and par 0022, 0024, 0039 & 0043). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the applicator of Barthe as modified by Hissong wherein said spaced-apart ultrasound transducers are planar ultrasound transducers as taught by Domankevitz since such a modification would amount to applying a known technique (i.e., as taught by Domankevitz) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as treating tissue at a region of interests using unfocused ultrasound containing at least one of muscle, tendon, ligament or cartilage (MTLC) tissue to achieve a therapeutic effect (see at least par 0024 of Domankevitz)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 27, Barthe as modified by Hissong discloses a method, as described above, that fails to explicitly teach a method wherein said spaced-apart ultrasound transducers are planar ultrasound transducers. However, Domankevitz teaches that it is known to provide a method wherein said spaced-apart ultrasound transducers 34 are planar ultrasound transducers 34 (see at least abstract, fig. 3 and par 0022, 0024, 0039 & 0043). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Barthe as modified by Hissong wherein said spaced-apart ultrasound transducers are planar ultrasound transducers as taught by Domankevitz since such a modification would amount to applying a known technique (i.e., as taught by Domankevitz) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as treating tissue at a region of interests using unfocused ultrasound containing at least one of muscle, tendon, ligament or cartilage (MTLC) tissue to achieve a therapeutic effect (see at least par 0024 of Domankevitz)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 29, Barthe discloses an applicator according to claim 2, wherein said transducers (19, 119, 219, 2404, 3104) are configured to emit said unfocused ultrasound energy with parameter values suitable to heat said at least one deep skin tissue volume to a temperature of 60 degrees Celsius, which is between 55-80 degrees Celsius (see at least par 0262).
In regards to claim 30, Barthe discloses a method according to claim 15, wherein said emitting comprises emitting said unfocused ultrasound energy (see at least par 0024 & 0091) by each of said two or more of said spaced- apart ultrasound transducers (19, 119, 219, 2404, 3104) with parameter values suitable to heat at least one deep skin tissue volume to a temperature of 60 degrees Celsius, which is between 55-80 degrees Celsius (see at least par 0262) to generate said vertically elongated thermal damage lesion (see at least fig. 38 and par 0273).
Claims 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barthe (‘294) in view of Domankevitz (‘212), Hissong (‘934), further in view of Brisken et al. (US 2003/0229331) (“Brisken” hereinafter).
In regards to claim 11, Barthe as modified by Domankevitz and Hissong discloses an applicator according to claim 16, that fails to explicitly teach an applicator discloses an applicator according to claim 16, that fails to explicitly teach an applicator wherein dimensions of said emitting surface are at least one of 1 mm X 8 mm, 2 mm X 5 mm, 3 mm X 4 mm, and 1 mm X 5mm. However, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the applicator of Barthe as modified by Domankevitz, Hissong and Brisken wherein dimensions of said emitting surface are at least one of 1 mm X 8 mm, 2 mm X 5 mm, 3 mm X 4 mm, and 1 mm X 5mm as claimed since it is well known that the transducer geometry and size are only ones of a few known ultrasonic parameters that are chosen in order to effect the formation of a lesion for a desired cosmetic approach (see at least par 0250 of US 2012/0271294).
In regards to claim 12, Barthe as modified by Domankevitz, and Brisken discloses an applicator according to claim 16, that fails to explicitly teach an applicator wherein a thickness of said piezo element is between 80-300 microns. However, Hissong teaches that it is known to provide an applicator wherein a thickness of said piezo element is between 80-300 microns (see at least par 0056). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the applicator of Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the applicator of Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the applicator of Barthe as modified by Domankevitz and Brisken wherein a thickness of said piezo element is between 80-300 microns as taught by Hissong since it is well known that the transducer geometry and size are only ones of a few known ultrasonic parameters that are chosen in order to effect the formation of a lesion for a desired cosmetic approach (see at least par 0250 of Barthe).
Claim(s) 13-14, 22 & 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US 2012/0271294) (“Barthe” hereinafter) in view of Domankevitz (US 2016/0310212), Hissong et al. (US 6,595,934) further in view of Spooner et al. (US 2008/0195000) (“Spooner” hereinafter).
In regards to claim 13, Barthe as modified by Domankevitz and Hissong discloses an applicator according to claim 2, as described above, that fails to explicitly teach an applicator wherein said cooling module is configured to apply said cooling via said ultrasound transducers while said plurality of ultrasound transducers are activated to emit said unfocused ultrasound energy with said selected skin treatment parameters. However, Spooner teaches that it is known to provide an applicator wherein said cooling module is configured to apply said cooling via said ultrasound transducers (34, 108) while said plurality of ultrasound transducers (34, 108) are activated to emit said ultrasound energy with said selected skin treatment parameters (see at least figs. 4 & 9 and par 0024-0025, 0054-0055 & 0057). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the applicator of Barthe as modified by Domankevitz and Hissong wherein said cooling module is configured to apply said cooling via said ultrasound transducers, as taught by Spooner, while said plurality of ultrasound transducers are activated to emit said unfocused ultrasound energy, as taught by Domankevitz, with said selected skin treatment parameters as taught by Barthe/Hissong since such a modification would amount to applying a known technique (i.e., as taught by Spooner) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as cooling superficial tissue layers such as the skin before, during and/or after application of ultrasound energy while underlying layers are heated by ultrasound energy as well as removing heat generated by the transducer (see at least par 0020 & 0025 of Spooner)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 14, while Barthe discloses an applicator according to claim 2, wherein each of said ultrasound transducers (19, 119, 219, 2404, 3104) has an energy emitting surface configured to be placed in contact, indirectly, with a skin surface (see at least abstract and figs. 26A & 35), Barthe as modified by Domankevitz and Hissong discloses an applicator, as described above, that fails to explicitly teach an applicator wherein said cooling module is configured to apply said cooling via said energy emitting surface of each of said ultrasound transducers to said surface of said skin contacting said ultrasound transducers to reduce said thermal damage to said skin surface. However, Spooner teaches that it is known to provide an applicator wherein said cooling module is configured to apply said cooling via said energy emitting surface of each of said ultrasound transducers (34, 108) to said surface of said skin contacting said ultrasound transducers (34, 108) to reduce said thermal damage to said skin surface (see at least figs. 4 & 9 and par 0024-0025, 0054-0055 & 0057). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the applicator of Barthe as modified by Domankevitz and Hissong wherein said cooling module is configured to apply said cooling via said energy emitting surface of each of said ultrasound transducers to said surface of said skin contacting said ultrasound transducers to reduce said thermal damage to said skin surface as taught by Spooner since such a modification would amount to applying a known technique (i.e., as taught by Spooner) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as cooling superficial tissue layers such as the skin before, during and/or after application of ultrasound energy while underlying layers are heated by ultrasound energy as well as removing heat generated by the transducer (see at least par 0020 & 0025 of Spooner)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 22, Barthe as modified by Domankevitz and Hissong discloses a method according to claim 21, as described above, that fails to explicitly teach a method wherein said cooling comprises cooling said spaced-apart ultrasound transducers, and cooling said skin surface via said cooled spaced-apart ultrasound transducers. However, Spooner teaches that it is known to provide a method wherein said cooling comprises cooling said spaced-apart ultrasound transducers (34, 108), and cooling said skin surface via said cooled spaced-apart ultrasound transducers (34, 108) (see at least figs. 4 & 9 and par 0024-0025, 0054-0055 & 0057). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Barthe as modified by Domankevitz and Hissong wherein said cooling comprises cooling said spaced-apart ultrasound transducers, and cooling said skin surface via said cooled spaced-apart ultrasound transducers as taught by Spooner since such a modification would amount to applying a known technique (i.e., as taught by Spooner) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as cooling superficial tissue layers such as the skin before, during and/or after application of ultrasound energy while underlying layers are heated by ultrasound energy as well as removing heat generated by the transducer (see at least par 0020 & 0025 of Spooner)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 28, Barthe as modified by Domankevitz and Hissong discloses an applicator according to claim 2, as described above, that fails to explicitly teach an applicator wherein said cooling module is configured to apply said cooling via each of said transducers. However, Spooner teaches that it is known to provide an applicator wherein said cooling module is configured to apply said cooling via said ultrasound transducers (34, 108) (see at least figs. 4 & 9 and par 0024-0025, 0054-0055 & 0057). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the applicator of Barthe as modified by Hissong wherein said cooling module is configured to apply said cooling via each of said transducers as taught by Spooner since such a modification would amount to applying a known technique (i.e., as taught by Spooner) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as cooling superficial tissue layers such as the skin before, during and/or after application of ultrasound energy while underlying layers are heated by ultrasound energy as well as removing heat generated by the transducer (see at least par 0020 & 0025 of Spooner)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Response to Arguments
Applicant's arguments filed January 30, 2026 have been fully considered but they are not persuasive. Applicant contends that the combination of Barthe, Domankevitz and Hissong fails to teach an applicator with said transducers configured to emit unfocused ultrasound energy with selected skin treatment parameters suitable to thermally damage at least a portion of a deep skin tissue volume. Applicant’s argument rests on the allegation that a skilled artisan would not make the combination based on the different methods set forth in Barthe, Domankevitz and Hissong. In response thereof, the Examiner notes that MPEP 2145 (X) stipulates:
Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Moreover, MPEP 2141 (I), states:
In KSR, the Supreme Court particularly emphasized “the need for caution in granting a
patent based on the combination of elements found in the prior art,”Id. at ___, 82 USPQ2d at 1395, and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”Id. at ___, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at ___, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” Id. at ___, 82 USPQ2d at 1395. (2) “In Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., . . . [t]he two [pre-existing elements] in combination did no more than they would in separate, sequential operation.”Id. at ___, 82 USPQ2d at 1395. (3) “[I]n Sakraida v. AG Pro, Inc., the Court derived . . . the conclusion that when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” Id. at ___, 82 USPQ2d at 1395-96 (Internal quotations omitted.). The principles underlining these cases are instructive when the question is whether a patent application claiming the combination of elements of prior art would have been obvious. [Emphasis added]
In the instant case, Barthe provides an applicator comprising an array of ultrasound transducer 19 and a method of use thereof as explained in the Office action. Barthe suggests using unfocused ultrasound to use the applicator thereof. Domankevitz teaches that it is known to provide an applicator of ultrasound transducers wherein each transducer produces an unfocused ultrasound while Hissong teaches that it is known to provide an array of ultrasound transducers wherein each transducer generates an elongated lesion. The Office, therefore, surmised that it would have an obvious expedient to modify Barthe by providing the transducer array thereof wherein each transducer generates an unfocused ultrasound as taught by Domankevitz, and wherein each transducer as modified by Domankevitz also produces a separate tissue lesion as taught by Hissong. The Office notes that the above-combination is a mere arranges of old elements with each performing the same function (e.g., array of transducers used to create lesions in tissue using unfocused ultrasound, individual ultrasound transducers used to generate unfocused ultrasound, and individual ultrasound transducers used to generate individual lesions) it had been known to perform and yields no more than one would expect from such an arrangement, therefore, the combination is obvious.
In view of the foregoing, the rejection over at least Barthe, Domankevitz and Hissong are maintained.
Conclusion
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/RENE T TOWA/Primary Examiner, Art Unit 3791
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