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 .
Claims 1-38 are presented for examination.
Applicants’ drawings and preliminary amendment filed May 5, 2022 have been received and entered.
Applicants’ information disclosure statement filed September 1, 2022 has been received and entered.
Applicants’ election filed July 24, 2025 in response to the restriction requirement of March 25, 2025 has been received and entered. The applicants elected the invention described in claims 1-27 (Group I) without traverse.
Claims 28-38 are withdrawn from consideration as being drawn to the non-elected invention (37 CFR 1.142(b)).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Rejections - 35 USC § 102
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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 10 and 22-27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2018/0369097 A1, hereby known as Zinger (A5) of PTO-1449.
Zinger teaches treatments of palmar and plantar hyperhidrosis (par. 3, 8) and discloses as a solution to this problem the topical application of an anti-cholinergic compound selected from oxybutynin (par. 35). In a preferred embodiment, the anti-cholinergic compound is coated or impregnated on a garment worn next to the skin such as a sock or a glove (par. 47, 105 and 106). Clearly, the cited reference anticipated applicants’ instant invention; therefore, applicants’ instant invention in unpatentable.
Claims 1, 2, 4, 10 and 22-27 are not allowed.
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 (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.
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.
The factual inquiries 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.
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.
Claim(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0369097 A1, hereby known as Zinger (A5) of PTO-1440 in view of EP 3023538 A1, hereby known as Taylor et al. (C2) of PTO-1449.
Zinger was discussed above supra for the palmar or plantar administration of anti-cholinergic compound in a human to treat palmar hyperhidrosis and/or plantar hyperhidrosis and the anti-cholinergic compound is coated or impregnated on a garment worn next to the skin such as a glove or sock.
The instant invention differs from the cited reference in that the cited reference does not teach the garment, such as a glove or sock, is made from cotton, nitrile, polyethylene, latex, butyl rubber, neoprene, wool, rayon, acrylic fiber, and combination thereof. However, the secondary reference, Taylor et al., teaches anti-perspirant gloves made out of polymeric materials such as nitrile rubber, nitrile latex, natural latex, latex, neoprene is well-known in the art.
Claims 1-10 are not allowed.
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 (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.
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.
The factual inquiries 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.
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.
Claim(s) 1-27 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0369097 A1, hereby known as Zinger (A5) of PTO-1449 in view of EP 3023538 A1, hereby known as Taylor et al. (C2) of PTO-1449 and further in view of Bobrove et al. (6,433,003 B1) or WO 2017/015485 A1, hereby known as Bodor et al.
Zinger was discussed above supra for the palmar or plantar administration of anti-cholinergic compound in a human to treat palmar hyperhidrosis and/or plantar hyperhidrosis and the anti-cholinergic compound is coated or impregnated on a garment worn next to the skin such as a glove or sock.
The secondary reference, Taylor et al., teaches anti-perspirant gloves made out of polymeric materials such as nitrile rubber, nitrile latex, natural latex, latex, neoprene is well-known in the art.
The instant invention differs from the cited references in that the cited references do not teach other anti-cholinergic compounds such as glycopyrronium compound(s) and sofpironium compound(s). However, the tertiary reference(s), Bobrove et al. or Bodor et al., each individually teach anti-cholinergic compounds are well-known in the art for topical administration to treat hyperhidrosis. Bobrove et al. teach topical administration of anti-cholinergic compound(s) such as glycopyrrolate compounds, and Bodor et al. teach topical formulation of sofpironium compounds such as sofpironium bromide. It would have been obvious to one of ordinary skill in the art at the time the invention was made to use any anti-cholinergic compound to treat palmar and/or plantar hyperhidrosis with a predictable expectation of successful treatment due to the compounds’ functional similarities.
The instant invention differs from the cited references in that the cited references do not teach the dosage amounts of anti-cholinergic compound. However, to determine the dosage amounts may be calculated according to body weight, body surface area or organ sizes. Further refinement of the calculations necessary to determine the appropriate dosage involving the above anti-cholinergic compound is routinely made by those of ordinary skill in the art and is within the ability of tasks routinely performed by them without undue experimentation.
Claims 1-27 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629