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 . 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.
Specification
The disclosure is objected to because the first paragraph does not provide the most current status for the related applications. The paragraph should be amended accordingly.
Furthermore, the lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 5, “patient’s skin” should be replaced with -subject’s skin-. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 11, 16, 19, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the subject’s tissue" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "a surface of the skin" in line 2. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “epidermis”.
Claim 11 recites the limitation "an epidermis" in line 2. The antecedent basis for this limitation is confusing, since it has already been recited.
Claim 16 recites the limitation "an epidermis" in line 2. The antecedent basis for this limitation is confusing, since it has already been recited.
Claim 19 recites the limitation "the subject’s epidermal tissue" in line 2. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “epidermis”.
Claim 20 recites the limitation "an uppermost region of the skin" in lines 2-3. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “epidermis”.
Claim 20 recites the limitations "subcutaneous tissue" and “subcutaneous layer” in line 4. The antecedent basis for these limitations is confusing, since it’s unclear how/whether they are related to each other, as well as the previously-recited “dermis” and “subcutaneous adipose tissue”.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of copending Application No. 16/736,672 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1-20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of copending Application No. 18/143,555 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 and 26-39 of copending Application No. 14/611,052 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the copending claims. Here, the more specific copending claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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) 1-11, 13-18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Altshuler, U.S. 2010/0036295 (hereinafter Altshuler).
Regarding claims 1-3 and 13, Altshuler discloses (note paragraphs 8, 52, 61, and 65) a method of treating a subject’s glands comprising: cooling a skin surface in the claimed manner to produce a freeze event (see above; note paragraphs 56 and 67); detecting the freeze event (note paragraph 140); and controlling a cooling device in the claimed manner to alter a level of production by the glands without injuring the epidermis (see above; note paragraph 67).
Regarding claims 4-5, Altshuler discloses (note paragraphs 8, 52, 61, and 65) a method that may or may not substantially affect lipid rich cells in a subcutaneous layer (i.e., depends on region of body being targeted; paragraph 65 discloses targeting “adipocytes and/or sebaceous glands”).
Regarding claim 6, Altshuler discloses (see above) a method further comprising thawing the subject’s frozen skin (note paragraphs 61, 65, and 150).
Regarding claims 7-8, Altshuler discloses (see above) a method that causes apoptotic damage without causing necrotic damage (note paragraph 8).
Regarding claims 9 and 11, Altshuler discloses (see above) a method necessarily comprising the claimed limitations (also note paragraphs 61, 65, and 150).
Regarding claim 10, Altshuler discloses (see above) a method comprising the claimed limitations (also note paragraph 56; fig. 2)
Regarding claim 14, Altshuler discloses (see above) a method that targets the claimed glands (note paragraph 61).
Regarding claims 15-17, Altshuler discloses (note paragraphs 8, 52, 61, and 65) a method of treating a subject’s glands comprising: cooling a skin surface in the claimed manner (see above; note paragraphs 56 and 67); and controlling a cooling device in the claimed manner to injure the dermal glands without injuring the epidermis and the subcutaneous adipose tissue (note paragraph 67 and see above; depends on region of body being targeted - paragraph 65 discloses targeting “adipocytes and/or sebaceous glands”).
Regarding claim 18, Altshuler discloses (see above) a method that targets the claimed glands (note paragraph 61).
Regarding claim 20, Altshuler discloses (see above) a method further comprising warming the subject’s skin (note paragraphs 61, 65, and 150).
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) 12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler in view of Elkins, U.S. 7,850,683 (hereinafter Elkins).
Regarding claims 12 and 19, Altshuler discloses (see above) a method of treating a subject’s glands comprising cooling a skin surface in the claimed manner to injure the underlying tissue without injuring the epidermis. However, Altshuler fails to explicitly disclose a method further comprising the step of delivering a cryoprotectant to the skin surface to protect the epidermis without inhibiting treatment of the underlying tissue. Elkins teaches a similar method that comprises the step of delivering a cryoprotectant to the skin surface to protect the epidermis without inhibiting treatment of the underlying tissue (note col. 3, line 16). This design is utilized in order to minimize unwanted tissue damage, thereby resulting in increased safety. 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 Altshuler to further comprise the step of delivering a cryoprotectant to the skin surface to provide additional protection to the epidermis, in order to increase safety.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794