DETAILED ACTION
Currently, claims 48-57 and 67-69 are being examined, while the remaining claims have been withdrawn or cancelled.
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 . 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 19, 2025 has been entered.
Claim Rejections - 35 USC § 112
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.
Claims 48-57 and 67-69 are 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 48 recites the limitation “the desired temperature is between minus 20 degrees Celsius and minus 10 degrees Celsius”, which removes the qualifier “approximately” from this range. However, there is insufficient support for this specific range of values in Applicant’s disclosure, since the term “approximately” is always included therein. Appropriate correction is required.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 48 and 51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hennemann, U.S. 2007/0282316 (hereinafter Hennemann).
Regarding claim 48, Hennemann discloses (note abstract) a method comprising: identifying treatment parameters for a desired tissue region of the subject for receiving a treatment including cooling, using a cooling device, to a desired temperature provided by the cooling device, wherein the treatment parameters comprise cooling the desired tissue region of the subject to the desired temperature, wherein the desired temperature is between minus 20 degrees Celsius and minus 10 degrees Celsius (note claim 7); applying the treatment using the treatment parameters; and eliciting formation of new collagen in the desired tissue region (note abstract).
Regarding claim 51, Hennemann discloses (see above) a method wherein the treatment necessarily includes a ‘bulk cooling process’.
Claim(s) 48 and 51-54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeBenedictis, U.S. 2015/0216719 (hereinafter DeBenedictis).
Regarding claim 48, DeBenedictis discloses (note abstract) a method comprising: identifying treatment parameters for a desired tissue region of the subject for receiving a treatment including cooling, using a cooling device, to a desired temperature provided by the cooling device, wherein the treatment parameters comprise cooling the desired tissue region of the subject to the desired temperature, wherein the desired temperature is between minus 20 degrees Celsius and minus 10 degrees Celsius (note paragraph 49); applying the treatment using the treatment parameters; and eliciting formation of new collagen in the desired tissue region (note paragraphs 56 and 82).
Regarding claim 51, DeBenedictis discloses (see above) a method wherein the treatment necessarily includes a ‘bulk cooling process’.
Regarding claim 52, DeBenedictis discloses (see above) a method wherein the desired tissue region includes tissue necessarily experiencing ‘laxity’ (note paragraph 50).
Regarding claim 53, DeBenedictis discloses (see above) a method wherein the desired tissue region includes cellulite (note abstract; paragraphs 49 and 50).
Regarding claim 54, DeBenedictis discloses (see above) a method wherein the treatment is part of a skin rejuvenation treatment process (note abstract).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 49, 50, 52-54, 67, and 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hennemann in view of Altshuler, U.S. 2010/0036295 (hereinafter Altshuler).
Regarding claims 49, 50, 52-54, 67, and 69, Hennemann discloses (see above) a cryo-procedure that elicits formation of new collagen in a body lumen. However, this procedure fails to explicitly disclose the treatment of skin that is experiencing laxity, wherein the treatment includes a fractional slurry injection using a needle. Altshuler teaches a similar cryo-procedure that elicits formation of new collagen (note paragraphs 63 and 69) in skin that is experiencing laxity (note paragraphs 7 and 51), wherein the treatment includes a fractional slurry injection using needles (note paragraphs 65 and 68-69). It is well known in the art that these comparable procedures could be performed at a variety of locations within/on the body of a patient, and that they could be performed in a variety of manners (e.g., using a fluid delivery catheter or needles). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the procedure of Hennemann to treat skin that is experiencing laxity, wherein the treatment includes a fractional slurry injection using needles. This is because this modification would have merely comprised a simple substitution of known target sites and techniques in order to produce a predictable (and desirable) result (see MPEP 2143).
Claim(s) 49, 50, 67, and 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeBenedictis in view of Altshuler.
Regarding claims 49, 50, 67, and 69, DeBenedictis discloses (see above) a cryo-procedure that elicits formation of new collagen in a patient’s body. However, this procedure fails to explicitly disclose a treatment including a fractional slurry injection using a needle. Altshuler teaches a similar cryo-procedure that elicits formation of new collagen (note paragraphs 63 and 69), wherein the treatment includes a fractional slurry injection using needles (note paragraphs 65 and 68-69). It is well known in the art that these comparable procedures could be performed in a variety of manners (e.g., with or without needles). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the procedure of DeBenedictis to include a fractional slurry injection using needles. This is because this modification would have merely comprised a simple substitution with known techniques in order to produce a predictable (and desirable) result (see MPEP 2143).
Claim(s) 55-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hennemann in view of Shadduck, U.S. 7,892,229 (hereinafter Shadduck).
Regarding claims 55-56, Hennemann discloses (see above) a cryo-procedure that targets a body lumen. However, this procedure fails to explicitly disclose treating breathing obstructions by targeting soft tissue within an airway. Shadduck teaches a similar cryo-procedure that treats breathing obstructions (note col. 1, line 57) by targeting soft tissue within an airway (note col. 15, line 35). It is well known in the art that these comparable procedures could be performed at a variety of locations within the body of a patient. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the procedure of Hennemann to treat breathing obstructions by targeting soft tissue within an airway. This is because this modification would have merely comprised a simple substitution of known target sites in order to produce a predictable result (see MPEP 2143).
Claim(s) 55-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeBenedictis in view of Shadduck.
Regarding claims 55-56, DeBenedictis discloses (see above) a cryo-procedure that targets multiple locations within/on a patient (note paragraph 67). However, this procedure fails to explicitly disclose treating breathing obstructions by targeting soft tissue within an airway. Shadduck teaches a similar cryo-procedure that treats breathing obstructions (note col. 1, line 57) by targeting soft tissue within an airway (note col. 15, line 35). It is well known in the art that these comparable procedures could be performed at a variety of locations within/on the body of a patient. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the procedure of DeBenedictis to treat breathing obstructions by targeting soft tissue within an airway. This is because this modification would have merely comprised a simple substitution of known target sites in order to produce a predictable result (see MPEP 2143).
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hennemann in view of Gallo, U.S. 2003/0125722 (hereinafter Gallo).
Regarding claim 57, Hennemann discloses (see above) a procedure that cryogenically revitalizes/rejuvenates tissue, but fails to explicitly disclose a procedure that further elicits an angiogenesis response. Gallo teaches a similar procedure (having similar parameters – note paragraph 32 of Hennemann, paragraph 21 of Gallo) that cryogenically revitalizes/rejuvenates tissue by eliciting an angiogenesis response (note paragraph 21). It is well known in the art that this additional functionality (i.e., the further eliciting of an angiogenesis response) would result in an enhanced procedure having increased efficiency and versatility. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified/enhanced the procedure of Hennemann to further elicit an angiogenesis response in order to increase efficiency and versatility.
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeBenedictis in view of Gallo.
Regarding claim 57, DeBenedictis discloses (see above) a procedure that cryogenically revitalizes/rejuvenates tissue, but fails to explicitly disclose a procedure that further elicits an angiogenesis response. Gallo teaches a similar procedure (having similar parameters – note paragraph 58 of DeBenedictis, paragraph 21 of Gallo) that cryogenically revitalizes/rejuvenates tissue by eliciting an angiogenesis response (note paragraph 21). It is well known in the art that this additional functionality (i.e., the further eliciting of an angiogenesis response) would result in an enhanced procedure having increased efficiency and versatility. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified/enhanced the procedure of DeBenedictis to further elicit an angiogenesis response in order to increase efficiency and versatility.
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hennemann in view of Altshuler as applied to claims 49, 50, 52-54, 67, and 69 above, and further in view of Ebbers, U.S. 2009/0118722 (hereinafter Ebbers).
Regarding claim 68, Hennemann in view of Altshuler teaches (see above) a procedure using a cooling device that comprises a plurality of needles. While Altshuler teaches needles that are used to target deeper tissue while protecting surface tissue (note paragraphs 9 and 51), the modified procedure fails to explicitly disclose that each of the needles includes insulation wrapped axially therearound, wherein the needle tips are uninsulated. Ebbers teaches (note fig. 4; paragraph 63) a similar procedure using a cooling device that comprises one or more needles, wherein each of the one or more needles includes insulation wrapped axially therearound, and wherein the needle tip is uninsulated. It is well known in the art that these different cooling needle configurations are widely considered to be interchangeable for performing such comparable procedures. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the procedure of Henneman such that each of the needles includes insulation wrapped axially therearound, and wherein the needle tips are uninsulated. This is because this modification would have merely comprised a simple substitution of interchangeable cooling needle configurations in order to produce a similar/predictable result (see MPEP 2143).
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeBenedictus in view of Altshuler as applied to claims 49, 50, 67, and 69 above, and further in view of Ebbers.
Regarding claim 68, DeBenedictus in view of Altshuler teaches (see above) a procedure using a cooling device that comprises a plurality of needles. While Altshuler teaches needles that are used to target deeper tissue while protecting surface tissue (note paragraphs 9 and 51), the modified procedure fails to explicitly disclose that each of the needles includes insulation wrapped axially therearound, wherein the needle tips are uninsulated. Ebbers teaches (note fig. 4; paragraph 63) a similar procedure using a cooling device that comprises one or more needles, wherein each of the one or more needles includes insulation wrapped axially therearound, and wherein the needle tip is uninsulated. It is well known in the art that these different cooling needle configurations are widely considered to be interchangeable for performing such comparable procedures. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the procedure of DeBenedictus such that each of the needles includes insulation wrapped axially therearound, and wherein the needle tips are uninsulated. This is because this modification would have merely comprised a simple substitution of interchangeable cooling needle configurations in order to produce a similar/predictable result (see MPEP 2143).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because they do not apply to the current rejections.
Conclusion
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794