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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/11/2026 has been entered.
Status of the Application
Claims 1-17 and 21-23 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 05/11/2026 are acknowledged. Claims under consideration in the instant office action are claims 1-24.
Applicants' arguments, filed 05/11/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 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.
Claims 1-17 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Mailland (US 2004/0022831, already of record) in view of Gatto (US 2016/0324769, already of record), Bouter (EP 2,462,991, already of record), and Singh (WO 2008/062429).
Mailland is drawn towards compositions comprising at least one antimycotic agent and a foaming agent which can be applied to nails to treat fungal nail diseases (see abstract; paragraphs 0004, 0058). Mailland teaches that the compositions can comprise clotrimazole, diclofenac, dimethyl sulphoxide (“DMSO”), and flucytosine (paragraphs 0017, 0046, 0052; see claim 3). Mailland teaches antimycotic agents in an amount of 0.1 to 15% (claim 2), penetration enhancers in an amount of 0 to 10% (paragraph 0052), and anti-inflammatory agents in an amount of 0.1 to 5% (paragraph 0047).
Mailland does not teach further administering a gel or ointment. Mailland does not teach a composition further comprising polyethylene glycol, water, Spiraea ulmaria flower extract, zinc acetate, and propylene glycol.
Bouter is drawn towards compositions for the treatment of nail infections (see abstract). Bouter teaches such compositions are a liquid or gel-based formulation, particularly for the treatment of fungal nail infections (see claims 12-13). It would be implicit to one of ordinary skill in the art to apply such compositions following other therapies against the nail infection (paragraph 0003).
Gatto is drawn towards topical compositions comprising Spiraea ulmaria extract to treat fungal or bacterial infections (claims 1, 14). Gatto teaches such compositions in the form of an ointment which can further comprise water (paragraphs 0066, 0085).
Singh is drawn towards compositions for the delivery of active agents such as flucytosine, which can be in the form of a gel or lotion (see abstract; claim 33). Singh teaches such compositions further comprising propylene glycol as a solvent, polyethylene glycol as a release rate modulating agent, and zinc acetate (pg. 12, lines 9-14; pg. 13, lines 7-12; see Table 1).
It would have been obvious to one of ordinary skill in the art to further administer a gel or ointment and further comprising Spiraea ulmaria extract, as suggested by Bouter and Gatto, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since it is prima facie obvious to combine components known for the same purpose for their combined additive effects, with a reasonable expectation of success absent evidence of criticality of the particular formulation. Additionally, “[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, it would have been prima facie obvious to administer a first and second nail composition cojointly to treat fungal infections.
It would have been obvious to one of ordinary skill in the art to formulate a composition further comprising polyethylene glycol, water, zinc acetate, and propylene glycol, as suggested by Gatto and Singh, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since such components are suitably and conventionally formulated with active agents such as flucytosine as taught by Gatto and Singh, with a reasonable expectation of success absent evidence of criticality of the particular formulation.
Even though the range for the components as taught by Mailland is not the same as the claimed components, Mailland does teach an overlapping range of component amounts, and it has been held that 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05(I). Furthermore, the determination of concentrations is well within the purview of those skilled in the art through routine experimentation, and it has been held that “it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art to optimize the component concentrations in order to increase efficacy of the antimycotic agents.
The amounts of active agents to be used, the pharmaceutical forms, e.g., tablets, etc; mode of administration, flavors, surfactant are all deemed obvious since they are all within the knowledge of the skilled pharmacologist and represent conventional formulations and modes of administration.
Furthermore, no unobviousness is seen in the ratio claimed because once the usefulness of a compound is known to treat a condition, it is within the skill of the artisan to determine the optimum ratio.
With regards to the limitation claimed in instant claim 23, which claims an application time of within 20 minutes, Mailland and Bouter do not specifically teach the exact amount claimed in instant claim 23. However, it would be within the skill of an ordinary artisan to be able to modify the application period in order to obtain the desired bioavailability of the agent. It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
Claims 1-17 and 21-23 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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