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
Election/Restriction
Claims 31-50 of 01/09/2023 are pending. Applicant's election without traverse of Group I, claims 34-40 in the Reply filed on 01/09/2023 is acknowledged. By way of applicant’s election dated 10/01/2025, claims 41-50 have been withdrawn from further consideration. Therefore, claims 34-40 are examined on the merits to which the following grounds of rejections are applicable.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The two information disclosure statements (IDS) submitted on 06/10/2022 and 07/25/2024 was filed before the mailing date of the instant first action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies thereof are enclosed herewith.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 33 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 33 does not limit base claim 31 in a proper manner. Specifically, base claim 31 recites the amount of 5-15% of propylene glycol while its dependent claim 33 also recites the amounts of propylene glycol “1.0%, 2.0%, 3.0% or 4.0%” which is outside scope of base claim 31. Therefore, it may not be said that claim 33 further limits claim 31.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 31-40 are rejected under 35 U.S.C. 103 as being unpatentable over Wotton et al. (US2014/0037713A1, IDS of 06/10/2022) in view of Pena et al. (WO2016/033313A1, IDS of 06/10/2022).
Applicant claims the below claims 31 and 39-40 filed on 01/09/2023:
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For examination purpose, claims 39-40 recites “(i)-(ii) and amount to be administered, but which is intended uses of the claimed composition. Please note that claims 39-40 are directed to a composition, not a method of use. The intended uses are not limited the scope of the claims because it merely defines a context in which the invention operates. See Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Moreover, the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Thus, "recitation of a new intended use for an old product does not make a claim to that old product patentable." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1977). Accordingly, when the prior art teaches a pharmaceutical composition in the form of spray, it reads on the claimed composition of instant claims 39-40.
Prior Art
Wotton discloses compositions or formulations for transdermal, transmucosal or topical administration ([0023]) for treating hyperhidrosis, comprising an anti-cholinergic agent such as oxybutynin in an about 0.1 to 10% which overlaps the instant range of 1.0-6.0%, and anti-cholinergic agent is administered in an amount of 25 to 100mg (claim 32 of prior art); an delivery vehicle including alkanol such as isopropanol in an amount of about 20- not more than 65% which 60-65% of the prior art overlaps the instant range of 60-70%; propylene glycol in an amount of 0.5 to 10% which overlaps the instant range of 5-15% or 1-6%; and water in an amount of about 10 to about 25% which overlaps the instant range of 5-20% (claims 1 and 28 of prior art). MPEP 2144.05: “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)”. Although the applied art does not expressly teach the claimed ratio 2:13:2.5 of propylene glycol: isopropanol: water, the applied art teaches overlapping amounts of them and thus one of the ordinary artisan would have optimized the ratio with the claimed ratio depending on the intended purpose, type of formulation, etc., in the absence of criticality evidence of the claimed ratio (instant claim 31, in part and instant claims 32-33). The composition further comprises at least one excipients such as gelling agents, antimicrobials, preservatives, antioxidants, buffers, humectants, sequestering agents, moisturizers, emollients, or film-forming agents (claim 25 of prior art) (instant claims 34-35) wherein the humectant includes glycerin, propylene, sorbitol, triacetin ([0055])(instant claim 36); since the composition contains anticholinergic agent and antimicrobials (e.g., abstract and claim 25 of prior art), the composition is anticholinergic and antimicrobial or anticholinergic and antibacterial (instant claim 37); the composition is provided in the form of topical gel, lotion, foam, cream, spray, aerosol, etc. ([0023] and [0074] and claim 26 of prior art)(instant claims 38-40). The composition or formulation is applied to axillae, face, palms or feet of individual (claim 32 of prior art) and the composition or formulation may be applied once daily, or multiple times per day depending on the condition of the patient ([0071]) and the formulation e.g., gel can be administered each morning for 7 consecutive days ([0105]); and the composition or formulation can be administered to animal or human ([0045] and [0068]).
However, Wotton does not expressly teach “glycopyrronium bromide” species of instant claim 31 as the anticholinergic agent. The deficiency is cured by Pena.
Pena discloses a topical composition for treating hyperhidrosis comprising anticholinergic agent such as glycopyrronium bromide compound, oxybutynin, etc. in an amount of about 0.25 to about 6% ([0017]) and one or more pharmaceutical carriers or excipients ([0259]) such as water, ethanol, propylene glycol ([0264]); and the composition is provided in the form of lotions, creams, gels, sprays, or ointments ([0263]); and the composition is applied to human or animal ([0041]).
It would have been prima facie obvious to replace anti-cholinergic agent, oxybutynin of Wotton with glycopyrronium bromide of Pena as a matter of choice or design because both compounds have equivalent function as the anticholinergic agent, and thus, such replacement would have yielded no more than predictable results of treating hyperhidrosis.
In light of the foregoing, instant claims 31-40 are obvious over Wotton in view of Penda.
Conclusion
All the examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613