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 .
Response to Amendments
Applicant’s amendments to the claims of March 2, 2026, in response to the Office Action of September 25, 2025, are acknowledged.
Response to Arguments
Applicant’s arguments and allegations of unexpected results have been considered by the examiner and are addressed below.
Applicant argues that Caillet-Bois is a generic and broad disclosure with hundreds of conditions to be treated. Applicant argues that Caillet-Bois does not teach any sprayable naftifine composition. Applicant argues that Caillet-Bois expressly teaches its compositions can be used in ‘systemic’ administration. Applicant argues that there is no reason to select octylacrylamide/acrylates copolymer “from the myriad of other polymers.” Applicant argues that the composition having the claimed octylacrylamide acrylate copolymer exhibited the shortest drying time while having good antifungal activity and skin penetration and high resistance to water and sweat. Applicant argues that the claimed ratio of propellant demonstrates a critical range in Example 2, Table 5. Applicant’s arguments are each responded to in depth below. Should Applicant’s representatives have any questions, they are encouraged to reach out to the examiner as he is will to schedule an interview at the After Final stage of prosecution.
The examiner notes that Caillet-Bois is used in combination with other references for methods of treatment and subject population teachings, which are well-known with the claimed API. Caillet-Bois does disclose naftifine in the claims among a limited list. Caillet-Bois also discloses a sprayable composition the forms a long-lasting film on the skin. See Abstract. A sprayable form is taught throughout. See par. 3 and 4, e.g. All 20 examples are sprayable forms.
Prior art claim 13 is directed to naftifine among a limited list;
Prior art claim 5 is directed to an octylacrylamide/acrylates copolymer as the single hydrophobic polymer claimed;
Prior art claim 22 is directed to a sprayable form with a propellant as a sole form; and
Ethanol is used in about 18 of 20 Examples and is provided in a concentration of 60-70% in a vast majority of them.
Thus, the examiner notes that in view of Caillet-Bois, ethanol, naftifine, octylacrylamide/acrylates copolymer, and a propellant in a sprayable form would be readily envisaged by a POSA.
The examiner also notes that the use of percutaneous by Caillet-Bois is defined to mean that it is achieves a “local or systemic effect.” See par. 1.
Schanbacher teaches topical agents for treating dermatophytic conditions such as tinea pedis. See abstract. Further, the vehicle in Example 2 includes ethanol not to exceed 75%. It is a preferred solvent discussed throughout. With reference to vehicles used to deliver active ingredients (i.e., antifungals) to the skin, “Of particular interest is ethanol (ethyl alcohol).” Ethanol is also preferred “due to its increased drying activity.” Further, “Ethanol is a preferred vehicle, because it evaporates quickly, produces a cooling sensation, and leaves the skin dry.” It does not leave an oily residue, which is a benefit as “Many existing topical antifungal applications…leave an oily residue.” Ethanol is quicky drying and leave no residue. Prior art claim 13 is limited to ethanol as solvent. Naftifine is listed among only a total of 5 antifungal agents.
Sherer is cited to provide teaches about cosmetic and dermatological sprayable compositions with a propellant. Scherer teaches and incorporates by reference propellant spays that includes a propellant gas being HFCs, butane, isobutane, or propane.
Scherer teaches a propellant of 35 to 65%, 40 to 60% and a particularly preferred amount to include 50% propellant. See par. 228. This is all that Scherer is needed and used to show.
Brown explains: “At present, the majority of volatile topical sprays employ a short chain hydrocarbon such as butane, propane, n-butane, or a mixture thereof, as the delivery vehicle.”
Even further, Umar teaches ultrasonic sprays have excellent potential to deliver film-forming solutions with a drop size that is 1 to 10 microns. Additionally, electrostatic sprays produce particles with a diameter of 6 to 10 microns. See p2911.
Ranade teaches topical film-forming dose sprays comprising an API, solvent, film-forming polymer, and permeation enhancer. The drying time for such film in an optimized batch was 30-50 seconds. See Table 3.
The examiner notes that a prima facie showing is established because Caillet-Bois teaches a film-forming spray to apply the claimed API with claimed solvent and claimed polymer and propellant. Further, the use of ethanol is taught to provide a fast drying time, alleviate a greasy feel, and is taught to be long lasting. Moreover, ultrasonic sprays are taught to be excellent at delivering film-forming sprays and do so with a particle size of 1 to 10 microns. Even further, a drying time for an optimized batch can be 30-50 seconds. The claimed API is known to treat claimed conditions and the benefits described appear to be taught and well-recognized by the cited prior art. The examiner acknowledges that the specific ratio of propellant to solvent is not explicitly taught by the prior art. However, Caillet-Bois teaches ethanol be at least 50% of the composition. This means that the propellant can only be up to 50% in a 1:1 ratio at most. Scherer is merely to cited to show that the state of art for propellant concentrations can be broad, including up to 32.94%. Further, the publication Scherer cites for this concentration indicates that a pharmaceutically acceptable propellant comprises about 5% to 60% of the formulation. Exemplary propellants are those claimed.
With respect to unexpected results, the examiner notes that this means unexpectedly superior as compared to the closest prior art, commensurate in scope with the breadth of the claims, and actually unexpected.
Here, the prior art teaches us that the claimed components will yield: faster drying times, longer-lasting films, and does not leave a greasy residue. Further, a drying time of 30-50 seconds is taught by Ranade. Thus, these parameters do not appear to be unexpected.
Example 2 in Table 5 is alleged to show unexpected results. The time to drying time appears to be the result. As noted above, a fast drying time is recognized by the prior art. However, even if faster drying times with higher concentrations of ethanol was not recognized in the art, the claimed are not commensurate in scope with the alleged results because it is not the ratio that matters. If 6% ethanol and 3% propellant were used, there is no expectation that anything would work as described. Dependent claim 14 provides for a concentration of 10% to 70% solvent. Further, dependent claim 23 provides for a concentration of 10% to 50% propellant and those claims by definition are further limiting. Thus, claim 1 must include even broader ranges.
The examiner cannot concludes that unexpected results are shown for the following reasons:
The claims do not include percentages for any components and therefore are not commensurate in scope with the allegations;
There is no comparison to the closest prior art embodiments to show a statistically significant benefit;
The unexpected features appear to be recognized in the art as a result of the use of optimization, e.g., with respect to faster drying, less greasy feel, longer lasting, and 30-50 second drying time are each taught to be advantages of claimed components;
A criticality has not been shown because a ratio of 3.9:1 has a full drying time that includes 70 seconds, which is the same drying time for a ratio of 1.8:1; and a ratio of 3.9:1 has a time to film formation that is about 58 seconds, which is almost identical to 60 seconds for a ratio of 1:1. It is not clear that ratios above 3:1 are statistically distinct and advantageous over ranges above and below that same ratio.
As a final note, Caillet-Bois provides an embodiment that can include a propellant. In view of the other embodiments, ethanol could be used at a minimum concentration of 50% and other agents can be used at low concentrations to include less than 1%. See par.’s 6-9. It is fair to deduce that in some circumstance, a propellant (if included) could be used in a concentration of up to about 50%. This would yield a ratio of about 1:1, which is claimed and percentages of about 50% for both ethanol and propellant fall within the concentrations claimed in dependent claims 14 and 23. Even further, if ethanol is used in a concentration of 60-70% as described in the examples, the use of a propellant would be in the range of 30-40% in view of the example of par.’s 6-9. Moreover, if the beneficial effect is primarily a result of the use of 60% ethanol (which has not been controlled for in the data), this is taught by the prior art. Table 5 shows that drying time and time to film formation are related and this would appear to be a result of the use of higher concentrations of ethanol as it is known to rapidly dissolve and dry upon application to the skin.
Status of the Claims
Claims 1, 3, 5, 7, 9, 11, 14, 19, 23, 25, 30, 43-45, 54, 63, 69, 75, 110, 111, and 116 are pending and examined.
Claim Rejections - 35 USC § 103
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, 3, 5, 7, 9, 11, 14, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Caillet-Bois et al., (US2011/0165097).
Caillet-Bois teaches a composition that can remain long-lasting as a film on the skin. See Abstract. The invention is a film-forming composition with 0.1-20% active agent and 0.5 to 30% hydrophobic polymer, and 50-99.4% one or more solvents, among other components. See par.’s 6-8. The hydrophobic polymer is octylacrylamide acrylate copolymer and the solvent can be ethanol. See par.’s 56 and 60. Further, the topical composition can be a sprayable form that can be applied with a pump sprayer, aerosol spray, and it includes a propellant. See par. 70. A spray can or pump sprayer are drug devices. The composition can be devoid of any hydrophilic polymer. See par. 81. The active agent can be naftifine. See prior art claim 13. The hydrophobic polymer can comprise 2-15% of the composition. See prior art claim 6. A permeation enhancer can be used. See prior art claim 19. Sprayable film solutions are taught, which is interpreted to include a monophasic composition. See Examples.
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); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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). This includes arriving at ratios of known result-effective variables.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed products in view of Caillet-Bois. One would be motivated to do so because Caillet-Bois teaches compositions to be applied to a subject in the form of a spray to form a film and deliver an API, including naftifine. Further, the claimed film forming polymer is taught, as well as ethanol as a solvent. Even further, concentrations of API, polymer, and solvents are taught and overlap and/or are optimizable in view of the cited prior art. Further, a device for spraying can include an aerosol spray or pump sprayer, e.g., which can deliver the composition to the skin of a subject. A propellant is also taught for inclusion, although a propellant is not required. A permeation enhancer and other components are also includable. As such, there is a reasonable and predictable expectation of success in arriving at the claimed compositions in view of the cited prior art through nothing more than routine optimization/experimentation.
Claims 1, 3, 5, 7, 9, 11, 14, 19, 23, 25, 30, 43-45, 54, 63, 69, 75, 110, 111, and 116 are rejected under 35 U.S.C. 103 as being unpatentable over Caillet-Bois et al., (US2011/0165097), in view of Schanbacher et al., (U.S. Pat. No. 10,251,822), in view of Scherer et al., (US2016/0346173), in view of Brown et al., (WO2007031753), in view of Umar et al., “Film-Forming Sprays for Topical Drug Delivery,” Drug Des Devel Ther. 2020 Jul 22;14:2909–2925, and in view of Ranade et al., “Fabrication of topical metered dose film forming sprays for pain management,” European Journal of Pharmaceutical Sciences 100 (2017) 132-141.
Caillet-Bois teaches a composition that can remain long-lasting as a film on the skin. See Abstract. The invention is a film-forming composition with 0.1-20% active agent and 0.5 to 30% hydrophobic polymer, and 50-99.4% one or more solvents, among other components. See par.’s 6-8. The hydrophobic polymer is octylacrylamide acrylate copolymer and the solvent can be ethanol. See par.’s 56 and 60. Further, the topical composition can be a sprayable form that can be applied with a pump sprayer, aerosol spray, and it includes a propellant. See par. 70. A spray can or pump sprayer are drug devices. The composition can be devoid of any hydrophilic polymer. See par. 81. The active agent can be naftifine. See prior art claim 13. The hydrophobic polymer can comprise 2-15% of the composition. See prior art claim 6. A permeation enhancer can be used. See prior art claim 19. Sprayable film solutions are taught, which is interpreted to include a monophasic composition. See Examples.
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); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
Schanbacher teaches compositions for treating dermatophytic conditions such as tinea pedis. See abstract. The active can be delivered as a spray onto the skin and ethanol is a preferred solvent. See Examples 2 and 3. The active agent is naftifine and the conditions treatable with the compositions include: tinea pedis, tinea cruris, tinea manuum. See prior art claims 1 and 5 and 10, e.g. Schanbacher also teaches a solution, which is interpreted as a monophasic form. See prior art claim 5, e.g. Schanbacher teaches that the claimed API is known to treat the claimed conditions when sprayed onto the skin of a subject. As evidenced by Peacock, “Tinea (tinea corporis, tinea capitis, tinea cruris, tinea pedis, barbae),” Core Dermatology Diagnoses/Infectious March 8 2020, tinea generally presents as a pruritic, erythrematous rash and it is typically annular with scale. Thus, when the claimed API is applied to treat a subject with a condition characterized by pruritus, erythema, and/or scaling, there is an expectation that those symptoms would be treated as the claimed composition is taught to be topically applied to treat subjects with the claimed forms of tinea.
Scherer teaches a cosmetic formulation comprising a propellant gas including a hydrofluorocarbon and a dermatologic formulation that can be sprayed. See Abstract. Naftifine can be used as an API. See par. 103. Ethanol is contemplated for use as a vehicle. See par. 248. The propellant gas can comprise up to 32.94% of the composition. See par. 137. The spray can be an aerosol from a spray can. See par. 5 and prior art claim 18. Aerosol atomizers or spray cans are known in the art to have nozzles that can form an atomized jet. See par. 4. These are examples of drug devices.
With regard to claim 54, the treatment needs to work compared to no treatment and/or compared to placebo. This merely means the API works. This is taught by the prior art.
Brown teaches topical compositions for human skin comprising hydrofluoralkane propellants and they can be used with ethanol as a co-solvent. See p6. Brown teaches that saturated, monophasic solutions of drug in solvent and propellant with a film-forming agent exhibit passive diffusion greater than predicted. See p8, 3rd par. The solution is at least 80% saturated. See prior art claim 2. The list of APIs that can be used include Naftifine as an antifungal. See p12. The film forming agent can be an acrylic or methacrylate co polymer, e.g. See p14.
Umar teaches ultrasonic sprays have excellent potential to deliver film-forming solutions with a drop size that is 1 to 10 microns. Additionally, electrostatic sprays produce particles with a diameter of 6 to 10 microns. See p2911.
Ranade teaches topical film-forming dose sprays comprising an API, solvent, film-forming polymer, and permeation enhancer. The drying time for such film in an optimized batch was 30-50 seconds. See Table 3. Ethanol was an organic solvent that could be used. See p125, last par. A value of 196.50 microns as X90 was expected to provide a smooth and uniform coverage to the skin. See p137. All droplets were in the range of 20 to 300 microns with a majority between 100 and 200 microns. Table 4 provides sizes of spray pump particles.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed products in view of Caillet-Bois, Schanbacher, Scherer, Brown, Umar, and Ranade. One would be motivated to do so because Caillet-Bois teaches compositions to be applied to a subject in the form of a spray to form a film and deliver an API, including naftifine. Further, the claimed film forming polymer is taught, as well as ethanol as a solvent. Even further, concentrations of API, polymer, and solvents are taught and overlap and/or are optimizable in view of the cited prior art. Further, a device for spraying can include an aerosol spray or pump sprayer, e.g., which can deliver the composition to the skin of a subject. A propellant is also taught for inclusion, although a propellant is not required. A permeation enhancer and other components are also includable. Schanbacher teaches using the claimed API in a spray form to tinea pedis, tinea cruris, tinea manuum. Scherer also teaches the claimed API with a propellant being a HFC for dermatologic use applied as a spray. Similarly, Brown teaches an 80% saturated monophasic skin composition comprising a hydrofluoralkane propellant and the claimed API. Umar teaches ultrasonic sprays to have a D90 that is greater than 1 micron and Ranade teaches topical film-forming dose sprays comprising an API, solvent, film-forming polymer, and permeation enhancer. The drying time for such film in an optimized batch was 30-50 seconds and a value of 196.50 microns provided a smooth and uniform coverage to the skin. All droplets were in the range of 20 to 300 microns with a majority between 100 and 200 microns. As such, there is a reasonable and predictable expectation of success in arriving at the claimed compositions in view of the cited prior art through nothing more than routine optimization/experimentation.
Conclusion
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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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