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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/17/2026 has been entered.
Status of the Claims
Claims 1-2 and 4-13 are pending and under current examination. Claim 3 is cancelled.
Withdrawn Claim Rejections
All rejections of record under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims filed 8/17/2026.
All rejections under 35 U.S.C. 102 are withdrawn in view of the amendments to the claims filed 8/17/2026.
All rejections not reiterated have been withdrawn.
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 9 and 13 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 9 does not recite the conjunction “and” or “or” before the final element of the Markush grouping. This renders the claim indefinite because it is not clear if the Markush grouping is closed. Please refer to MPEP 2173.05(h):
When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper.
Claim 13 recites the limitation “a concentration of 0.5 to 10%”. This renders the claim indefinite because it is not clear what property the concentration is describing (i.e., weight or volume).
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.
Claims 4 and 5 are 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 4 recites the limitation that the antifungal agent solvent comprises a heterocyclic acetyl solvent. This does not further limit claim 1, which recites the limitation that the antifungal agent solvent comprises dioxolane. Therefore, claim 4 fails to further limit the subject matter of claim 1.
Regarding claim 5, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the dependency concerns outlined above.
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 1, 2, 4-7, 9-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Besonov (U.S. Patent Application No. 2009/0130029, cited in the IDS filed 11/6/2025, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Besonov teaches a pharmaceutical vehicle comprising at least one glycerol ether, at least one stabilizer, and water [0009]. The composition may also include a polar solvent such as dioxolane [0059]. The composition may include terbinafine HCL at a concentration of 1% by weight [0395]. The volatile glycerol ether is present in the composition in an amount sufficient to solubilize the active agent [0021]. The foamable composition is substantially alcohol-free [0204] and may generate a single-phase formulation or substantially homogenous suspension (Claim 22). The Examiner considers the phrase “single phase formulation” to read on the “solution” limitation of the instant claim. The composition may be in a non-foam state [0108]. The Examiner considers the phrase “non-foam state” to read on the “fluid” limitation of the instant claim. Polar solvents are known to enhance the penetration of active agent into the skin and through the skin [0234] and possess high solubilizing capacity [0235].
Regarding claim 2, Besonov teaches that the composition may include a polymeric agent such as polyethylene glycol [0154].
Regarding claims 4 and 5, Besonov teaches that the composition may also include a polar solvent such as dioxolane [0059].
Regarding claim 6, Besonov teaches that the composition may include an emollient [0017], moisturizer [0225], anti-inflammatory agents [0275-0276], deodorant [0065], and an antibacterial agent [0054]. Besonov also teaches that the surface-active agents of the composition are also termed surfactants [0161].
Regarding claim 7, Besonov teaches that the composition may include essential oils [0058].
Regarding claim 9, Besonov teaches that the composition may include glycerin [0223] and cottonseed oil [0147].
Regarding claim 10, Besonov teaches that the composition may include tocopheryl acetate and tocopheryl linoleate [0147].
Regarding claim 11, Besonov teaches that the composition may include sorbitan monolaurate [0049].
Regarding claim 13, Besonov teaches that the volatile glycerol ether is present in the composition in an amount sufficient to solubilize the active agent [0021] and that polar solvents are known to enhance the penetration of active agent into the skin and through the skin [0234] and possess high solubilizing capacity [0235].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1, 2, 4-7, and 9-11, Besonov doesn’t teach a single embodiment or example meeting all limitation of the invention of claims 1, 2, 4-7, and 9-11.
Regarding claim 13, Besonov does not teach a weight percentage of the antifungal agent solvent.
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1, 2, 4-7, and 9-11, within the broader scope of Besonov all of the limitations of the invention of claims 1, 2, 4-7, and 9-11 are met. It would have been prima facie obvious for one having ordinary skill in the art to choose the limitations in the instant claims from those disclosed by Besonov and arrive at this conclusion because such was contemplated by Besonov.
Regarding claim 13, the weight percentage of antifungal agent solvent is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight percentage in order to best achieve the desired results as such would provide advantageous solubilization and enhanced penetration effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where 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, 105 USPQ 233 (CCPA 1955). In the instant case, Besonov teaches that the volatile glycerol ether and polar solvent such as dioxolane both work to enhance the solubility of the ingredients and that the polar solvent increases penetration of active agent into the skin and through the skin. The Examiner considers it prima facie obvious to optimize the weight percentage of the antifungal agent solvent, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amount of solvent present would have a direct effect on the solubilization and penetration of the active agent and therefore be an optimizable variable.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Besonov (U.S. Patent Application Publication No. 2009/0130029, publication year: 2009, cited in the IDS filed 11/6/2025, of record), as applied to claims 1, 2, 4-7, 9-11, and 13 above, and further in view of Tamarkin (WO 2008/075207, publication year: 2008, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Besonov teaches that the composition may include essential oils [0058].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Besonov does not teach a specific essential oil as recited by the instant claim. However, this deficiency is cured by Tamarkin.
Tamarkin teaches a foamable liquid composition for treating infection comprising water and terbinafine HCl in a concentration of 1% w/w of the solution [0319]. The composition is free from short chain alcohols [0084]. Tamarkin also teaches that may contain an oil or extract of eucalyptus, peppermint, lavender, and tea tree (Claim 17 d).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
The idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional essential oils used in topical antifungal compositions comprising terbinafine HCl. It would follow that the recited claims define prima facie obvious subject matter. See MPEP 2144.06.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Besonov (U.S. Patent Application Publication No. 2009/0130029, publication year: 2009, cited in the IDS filed 11/6/2025, of record), as applied to claims 1, 2, 4-7, 9-11, and 13 above, and further in view of Villalobos (U.S. Patent Application Publication No. 2012/0061267, publication year: 2012, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Besonov teaches that the composition may be in a non-foam state [0108].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Besonov does not teach the solution formulated as a lotion, cream, spray, or wipe. However, this deficiency is cured by Villalobos.
Villalobos teaches a packaged antifungal towelette comprising a disposable sheet material for single-use wiping of the feet and body and a terbinafine hydrochloride solution impregnated in the sheet material (Claim 1).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (the disposable wipe of Villalobos and the antifungal composition of Besonov for the purpose of forming an antifungal treatment composition), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
Response to Arguments
Applicant's arguments filed 8/17/2026 have been fully considered but they are not persuasive.
On page 4, Applicant argues that Besonov mentions dioxolane in a list of solvents but does not indicate which active agent can be solubilized using dioxolane and that this is insufficient to teach that an antifungal agent can be solubilized in solution using dioxolane. This is not found persuasive. In response, please refer to MPEP 2123 (I), which states “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments”. Please also refer to MPEP 2141.03(I) regarding the factors to consider when determining level of ordinary skill: "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. In the instant case, the amended claim 1 requires that the antifungal agent solvent comprises dioxolane, not that the dioxolane alone must solubilize the antifungal agent. As described in the obviousness rejection above, Besonov teaches that both the volatile glycerol ether and polar solvent, such as dioxolane, may serve to solubilize the ingredients of the composition. Therefore, one of ordinary skill in the art could have reasonably concluded that both the volatile glycerol ether and dioxolane may be utilized to solubilize the antifungal agent.
On page 5, Applicant argues that Besonov is directed to foamable compositions, which are dispensed under pressure from the container as foam while Applicant’s invention is directed to a solution formulated for application to the skin as a fluid. This is not found persuasive. In response, please refer to MPEP 2123 (I), which states “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments”. As described in the obviousness rejection above, Besonov teaches that the composition may be in a non-foam state. Therefore, one of ordinary skill in the art could have reasonably concluded that while the composition is foamable, it may be in a non-foam state. The Examiner considers the phrase “non-foam state” to read on the “fluid” limitation of the instant claims.
On page 7, Applicant argues that Besonov teaches that the solvent may be present in the range of 40% to 60%. This is not found persuasive. As described in the obviousness rejection above, Besonov does not teach a weight percentage of the polar solvent present in the composition. The weight range cited by the applicant applies to the potent solvent that may be present in the composition, which is included in addition to or in place of the hydrophobic solvents, polar solvents or emollients of the composition (see Besonov at [0238]). Therefore, in view of the teachings of Besonov, one of ordinary skill in the art would have recognized the weight percentage of polar solvent present in the composition is a result effective parameter that one of skill in the art would routinely optimize.
Double Patenting
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4-8, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,993,890.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Inter alia, the claims of the ‘890 patent embrace a treatment solution comprising an antifungal agent, a carrier fluid, and an antifungal agent solvent. The antifungal agent is tolnaftate in a concentration of at least 1 wt.% of the total solution and the alcohol content is 1 wt. % or below. The specification of the ‘890 patent defines a carrier fluid to include water and ethylene glycol or water and polyethylene glycol (col. 3 lines 36-45). The Examiner has relied upon the specification to delineate the scope of the invention embraced by the ‘890 patent, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797. The antifungal agent solvent comprises a dioxolane. The treatment solution also includes emollients, surfactants, essential oils, thickening agents, texturizers, preservatives, and exfoliants. The solution includes at least one of peppermint and eucalyptus. The dioxolane has a concentration in the range of 2 wt.% to 4 wt.% of the total solution.
Claims 9-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,993,890, as applied to claims 1, 2, 4-8, and 13 above, and further in view of Besonov (U.S. Patent Application No. 2009/0130029, publication year: 2009, cited in the IDS filed 11/6/2025, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Inter alia, the claims of the ‘890 patent embrace the relevant limitations as described above. The claims of the ‘890 patent do not embrace the compounds recited by the instant claims 9, 10 or 11. However, this deficiency is cured by Besonov. Besonov teaches a pharmaceutical vehicle comprising at least one glycerol ether, at least one stabilizer, and water [0009]. The composition may include terbinafine HCL at a concentration of 1% by weight [0395]. Besonov also teaches that the composition may include glycerin as a humectant, moisturizer, polar solvent, and skin penetration enhancer [0223, 0224, 0231, and 0236], cottonseed oil [0147], tocopheryl acetate, tocopheryl linoleate [0147], and sorbitan monolaurate [0049].
The idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional ingredients and carrier liquids used in a solution for topical administration of terbinafine hydrochloride. It would follow that the recited claims define prima facie obvious subject matter. See MPEP 2144.06.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,993,890, as applied to claims 1, 2, 4-8, and 13 above, and further in view of Villalobos (U.S. Patent Application Publication No. 2012/0061267, publication year: 2012, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Inter alia, the claims of the ‘890 patent embrace the relevant limitations as described above. The claims of the ‘890 patent do not embrace a lotion, cream, spray or wipe that contains the treatment solution. However, this deficiency is cured by Villalobos.
Villalobos teaches a packaged antifungal towelette comprising a disposable sheet material for single-use wiping of the feet and body and a terbinafine hydrochloride solution impregnated in the sheet material (Claim 1). Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (the disposable wipe of Villalobos and the antifungal composition of the claims of the ‘890 patent for the purpose of forming an antifungal treatment composition), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
Claims 1,2, 4-7, and 9-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,571,370 in view of Besonov (U.S. Patent Application No. 2009/0130029, publication year: 2009, cited in the IDS filed 11/6/2025, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Inter alia, the claims of the ‘370 patent embrace a wipe comprising a treatment solution impregnated into the substrate. The treatment solution comprises an antifungal agent, a carrier fluid, and an antifungal agent solvent comprising a dioxolane solvent. The treatment solution has an alcohol content of 6 wt. % or below. The Examiner considers the phrase “alcohol content of 6 wt. % or below” to read on the “treatment solution is alcohol free” limitation of the instant claim 1. The specification of the ‘370 patent defines a carrier fluid to include water and ethylene glycol or water and polyethylene glycol (col. 3 lines 44-46). The Examiner has relied upon the specification to delineate the scope of the invention embraced by the ‘370 patent, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
The claims of the ‘370 patent do not embrace a weight percentage of antifungal agent or solvent present in the solution, essential oils, or the ingredients embraced by the instant claims 6 and 9-11. However, this deficiency is cured by Besonov.
Besonov teaches a pharmaceutical vehicle comprising at least one glycerol ether, at least one stabilizer, and water [0009]. The composition may include terbinafine HCL at a concentration of 1% by weight [0395]. The volatile glycerol ether is present in the composition in an amount sufficient to solubilize the active agent [0021]. The foamable composition is substantially alcohol-free [0204] and may generate a single-phase formulation or substantially homogenous suspension (Claim 22). The Examiner considers the phrase “single phase formulation” to read on the “solution” limitation of the instant claim. Besonov teaches that the composition may include an emollient [0017], moisturizer [0225], anti-inflammatory agents [0275-0276], deodorant [0065], an antibacterial agent [0054], essential oils [0058], glycerin [0223], cottonseed oil [0147], tocopheryl acetate, tocopheryl linoleate [0147], and sorbitan monolaurate [0049]. Besonov also teaches that the active agents are included in a therapeutically effective concentration [0239]. The composition may also include a polar solvent such as dioxolane [0059]. Polar solvents are known to enhance the penetration of active agent into the skin and through the skin [0234] and possess high solubilizing capacity [0235].
The weight percentage of antifungal agent present in the composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal the weight percentage of anti-fungal agent in the composition in order to best achieve the desired results as such would provide advantageous therapeutic effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where 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, 105 USPQ 233 (CCPA 1955). In the instant case, Besonov teaches that the active agent is present in the composition in a therapeutically effective amount [0239]. The Examiner considers it prima facie obvious to optimize the weight percentage of the anti-fungal agent present in the composition, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the weight percentage of anti-fungal agent present in the composition would have a direct effect on the therapeutic effectiveness of the composition and therefore be an optimizable variable.
The weight percentage of antifungal agent solvent is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight percentage in order to best achieve the desired results as such would provide advantageous solubilization and enhanced penetration effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where 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, 105 USPQ 233 (CCPA 1955). In the instant case, Besonov teaches that the volatile glycerol ether and polar solvent such as dioxolane both work to enhance the solubility of the ingredients and that the polar solvent increases penetration of active agent into the skin and through the skin. The Examiner considers it prima facie obvious to optimize the weight percentage of the antifungal agent solvent, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amount of solvent present would have a direct effect on the solubilization and penetration of the active agent and therefore be an optimizable variable.
The idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional ingredients used in a solution for topical administration of an antifungal agent. It would follow that the recited claims define prima facie obvious subject matter. See MPEP 2144.06.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,571,370 in view of Besonov (U.S. Patent Application No. 2009/0130029, publication year: 2009, cited in the IDS filed 11/6/2025, of record), as applied to claims 1, 2, 4-7, and 9-13 above, and further in view of Tamarkin (WO 2008/075207, publication year: 2008, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘370 patent embrace the relevant limitations as described above. The claims of the ‘370 patent do not embrace an essential oil present in the composition. However, this deficiency is cured by Tamarkin. Tamarkin teaches a foamable liquid composition for treating infection comprising water and terbinafine HCl in a concentration of 1% w/w of the solution [0319]. The composition is free from short chain alcohols [0084]. Tamarkin also teaches that may contain an oil or extract of eucalyptus, peppermint, lavender, and tea tree (Claim 17 d).
The idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional essential oils used in topical antifungal compositions comprising an antifungal agent. It would follow that the recited claims define prima facie obvious subject matter. See MPEP 2144.06.
Claims 1, 4, 5, 7-8, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-17 and 21-23 of copending Application No. 18/163,131.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘131 application teach a treatment solution that is essentially free of alcohol comprising a carrier fluid, an antifungal agent, and an antifungal agent solvent to solubilize the antifungal agent into the solution. The antifungal agent may be tolnaftate, terbinafine hydrochloride, or miconazole nitrate and has a concentration of at least 1 wt.% of the total solution. The antifungal agent solvent comprises a heterocyclic acetal solvent such as dioxolane and has a concentration in the range of 2-4 wt.% by weight of the total solution. The treatment solution may also comprise at least one of peppermint and eucalyptus. The examiner interprets the inclusion of peppermint and eucalyptus in the claims of the ’131 application to encompass the inclusion of essential oils of the same plants in the instant claims 7 and 8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 6, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-17 and 21-23 of copending Application No. 18/163,131, as applied to claims 1, 3-5, 7-8, and 13 above, and further in view of Besonov (U.S. Patent Application No. 2009/0130029, cited in the IDS filed 11/6/2025, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘131 application embrace the relevant limitations as described above. The claims of the ‘131 application do not embrace a carrier fluid comprised of water and one of either ethylene glycol or polyethylene glycol or the inclusion of an emollient or surfactant within the composition. The claims of the ‘131 application also do not embrace the inclusion of at least one of glycerin, gossypium herbaceum (cotton seed oil), polyglyceryl-4 laurate, dilaurly citrate, ethylexyl stearate, caprylyl glycol (a combination of gossypium herbaceum(cotton seed oil), polyglyceryl-4 laurate, dilaurly citrate, and ethylexyl stearate, at least one of vitamin E, vitamin E esters and salts thereof, tocopheryl acetate, tocopheryl succinate, tocopheryl nicotinate, tocopheryl linolate, and alpha-tocopheryl phosphates, and at least one of sodium lauroyl sarcosinate, sodium laurylamphoacetate, and sorbitan laurate. However, these deficiencies are cured by Besonov.
Besonov teaches a pharmaceutical vehicle comprising at least one glycerol ether, at least one stabilizer, and water [0009]. The composition may include terbinafine HCL at a concentration of 1% by weight [0395]. The volatile glycerol ether is present in the composition in an amount sufficient to solubilize the active agent [0021]. The foamable composition is substantially alcohol-free [0204] and may generate a single-phase formulation or substantially homogenous suspension (Claim 22). The Examiner considers the phrase “single phase formulation” to read on the “solution” limitation of the instant claims. Besonov teaches that the composition may also include a polymeric agent such as polyethylene glycol [0154], an emollient [0017], moisturizer [0225], anti-inflammatory agents [0275-0276], deodorant [0065], and an antibacterial agent [0054]. Besonov also teaches that the surface-active agents of the composition are also termed surfactants [0161]. Besonov also teaches that the composition may include glycerin [0223], cottonseed oil [0147], tocopheryl acetate, tocopheryl linoleate [0147], and sorbitan monolaurate [0049].
The idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional ingredients used in a solution for topical administration of terbinafine hydrochloride. It would follow that the recited claims define prima facie obvious subject matter. See MPEP 2144.06.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 12 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-17 and 21-23 of copending Application No. 18/163,131, as applied to claims 1, 3-5, 7-8, and 13 above, and further in view of Villalobos (U.S. Patent Application Publication No. 2012/0061267, publication year: 2012, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘131 application embrace the relevant limitations as described above. The claims of the ‘131 application do not embrace the treatment solution as a lotion, a cream, a spray, or a wipe that contains the treatment solution. However, this deficiency is cured by Villalobos.
Villalobos teaches a packaged antifungal towelette comprising a disposable sheet material for single-use wiping of the feet and body and a terbinafine hydrochloride solution impregnated in the sheet material (Claim 1). Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (the disposable wipe of Villalobos and the antifungal composition of the claims of the ‘131 application for the purpose of forming an antifungal treatment composition), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 8/17/2026 have been fully considered but they are not persuasive.
Applicants’ request for the double patenting rejection of record to be held in abeyance is acknowledged. However, this request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Accordingly, the rejection will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejection.
Conclusion
No claims are allowed.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
