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 .
Status of the Claims
Claims 1, 2, and 4-12 are pending and under current examination.
Withdrawn Claim Rejections
All rejections pertaining to claim 6 under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims filed 4/7/2026.
All rejections not reiterated have been withdrawn.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.
Claim 9 is 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 recites “caprylyl glycol (a combination of gossypium herbaceum, polyglyceryl-4-laurate, dilaurly citrate, and ethylexyl stearate)”. This renders the claim indefinite because it is not clear if the claim describes a combination of caprylyl glycol, gossypium herbaceum, polyglyceryl-4-laurate, dilaurly citrate, and ethylexyl stearate or if the claim is defining caprylyl glycol to include a combination of gossypium herbaceum, polyglyceryl-4-laurate, dilaurly citrate, and ethylexyl stearate. Furthermore, it is not clear how caprylyl glycol, a distinct chemical, may be composed of gossypium herbaceum, polyglyceryl-4-laurate, dilaurly citrate, and ethylexyl stearate.
Response to Arguments
Applicant's arguments filed 4/7/2026 regarding the rejection of claim 9 under 35 U.S.C. 112(b) have been fully considered but they are not persuasive. The amendments to the claims filed 4/7/2026 have addressed the missing parenthesis in the instant claim 9, but have not addressed the indefiniteness concerns regarding the phrase “caprylyl glycol (a combination of gossypium herbaceum, polyglyceryl-4 laurate, dilaurly citrate, and ethylexyl stearate)” as described in the indefiniteness rejection above.
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)(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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGraw (U.S. Patent No. 4,438,134, issue date: 3/20/1984, of record), as evidenced by Sawaya (U.S. Patent No. 5,519,059, issue date: 5/21/1996, of record).
Regarding claim 1, McGraw discloses a method of treating herpes I infections wherein tolnaftate is dissolved in a 1% concentration in a homogenous carrier of polyethylene glycol 400, propylene glycol, carboxypolymethylene, monoamylamine, butylated hydroxytoluene, stearic acid and water (Claim 2). The Examiner considers the phrase “dissolved” to read on the “treatment solution” limitation of the instant claim. It is noted that McGraw is silent with regards to alcohol and therefore reads on the “alcohol free” limitation of instant claim 1. With regards to the “antifungal agent solvent” limitation of instant claim 1, the prior art teaches a solution in which tolnaftate is dissolved in a carrier liquid comprising water and other ingredients, including polyethylene glycol 40 and propylene glycol and therefore, the antifungal agent solvent properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” As additional evidence, Sawaya teaches that tolnaftate is soluble in polyethylene glycol 400 (col. 3 line 3) and propylene glycol (col. 3 line 11).
Regarding claim 2, McGraw discloses a method of treating herpes I infections wherein tolnaftate is dissolved in a 1% concentration in a homogenous carrier of polyethylene glycol 400, propylene glycol, carboxypolymethylene, monoamylamine, butylated hydroxytoluene, stearic acid and water (Claim 2).
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, and 9-11 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 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.
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].
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.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over 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 9-11, 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 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 9-11, 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 4/7/2026 have been fully considered but they are not persuasive.
On page 4, Applicant argues that claims 1 and 2 are patentable distinguishable over the prior art because McGraw teaches the inclusion of propylene glycol, an alcohol. This is not found persuasive. In response, the Examiner respectfully draws attention to MPEP 2111.01 (IV), which states: “the only exceptions to giving the words in a claim their ordinary and customary meaning in the art are (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification”. The Applicant defines alcohols to mean SD alcohol, denatured alcohol, isopropyl alcohol, ethanol, and mixtures thereof [0017 of the instant specification]. The Examiner therefore considers the phrase “alcohol free” in the instant claim 1 to exclude SD alcohol, denatured alcohol, isopropyl alcohol, ethanol, and mixtures thereof and thus the teachings of McGraw to read on the limitations of the instant claims 1 and 2.
On page 5, Applicant argues that the term “single phase formulation” does not necessarily mean a solution and that there is no clarification of whether the term is clarified by the statement of “substantially homogenous suspension”. This is not found persuasive. In response, the Examiner respectfully draws attention 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 automation.” 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, Besonov teaches that 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]. One of ordinary skill in the art would have recognized in view of the teachings of Besonov that the active ingredient is solubilized in the composition and would thus infer that the term “single phase formulation” reads on the “solution” limitation of the instant claims. Therefore, the argument is not persuasive and the rejection is maintained.
On page 5, Applicant argues that assuming that the term “single phase formulation” means a solution is based on impermissible hindsight. This is not found persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As described above, a person of ordinary skill in the art would have reasonably concluded, based on the teachings of Besonov, that the term “single phase formulation” reads on the “solution” limitation of the instant claims.
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, and 4-8 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.
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, and 4-8 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, and 4-8 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 9-12 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 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 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 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 9-12 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 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 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. 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 1-23 of copending Application No. 18/163,131, as applied to claims 1, 3-5, 7 and 8 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 1-23 of copending Application No. 18/163,131, as applied to claims 1, 3-5, 7 and 8 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 4/7/2026 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.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
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