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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/25/2025 has been entered.
Applicants’ arguments, filed 11/25/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
Claims 1, 2, 4, 6, 7, 11, 12, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Tamarkin ‘414 (US 2005/0074414 A1, publication date 04/07/2005) in view of Lathrop et al. (US 2006/0204526 A1, publication date 09/14/2006) and Tamarkin ‘029 (US 2009/0130029 A1, publication date 05/21/2009), as evidenced by HARP AP70 (HARP International, HARP AP70 Product Specification, June 2014; previously cited).
Regarding instant claims 1, 7, 11 and 26, Tamarkin ‘414 “relates to an alcohol-free cosmetic or pharmaceutical foam composition comprising water, a hydrophobic solvent, a surface-active agent, a gelling agent, an active component selected from the group of urea, hydroxy acid and a therapeutic enhancer and a propellant” [abstract]. According to Tamarkin ‘414 “ the surface-active agent has a hydrophilic lipophilic balance (HLB) between about 9 and about 14, which is the required HLB (the HLB required to stabilize an O/W emulsion of a given oil) of most oils and hydrophobic solvents” [0038] and that the “[t]otal surfactant level is in the range of about 0.1 % to 5% by weight of the foamable composition” [0042]. Appropriate surfactants include polysorbates such as Tween 20 [0039]. Tamarkin ‘414 also discloses the composition may comprise foam adjuvants such as fatty alcohols, for example, mixtures of cetyl alcohol and stearyl alcohol (i.e., cetearyl alcohol) [0044]. The therapeutic enhancer “facilitates an enhanced delivery of an active agent into a target site of treatment” [0071]. According to Tamarkin ‘414 the therapeutic enhancer may be diethylene glycol monoethyl ether [0073] may be present in amounts from 2 to 30% w/w [0074]. Additionally, compositions comprising diethylene glycol monoethyl ether (i.e., transcutol) appear to be preferred (see p. 2, Example 2; p. 13, Example 3; p. 14, Example 5). Tamarkin ‘414 discloses that “customary liquefied propellant can be added, in the amount of about 3-18% of the total composition. … including high purity hydrocarbons such as propane, isobutane and n-butane, dimethyl ether and chlorofluorocarbons (CFCs)” (i.e., propellant to emulsion ratio of: 3:97-18:82, or reduced to: 1:32.33-1:4.5) [0178]. Tamarkin ‘414 discloses the active agent may be ketoconazole [0086]. Finally, Tamarkin ‘414 discloses suitable hydrophobic solvents include isopropyl myristate [Examples 2-5, paragraphs 210-213].
Tamarkin ‘414 does not disclose dicetyl phosphate and ceteareth-10 phosphate and the specific blend of propellant instantly claimed.
Lathrop relates to topical emulsions of Dapsone and discloses that stable emulsions are “achieved through the use of a combination of certain surfactant mixtures and an enhancer providing solubility of the Dapsone” [abstract]. Lathrop discloses that Dapsone is “difficult to formulate as aqueous based topical compositions. The compounds themselves readily separate and/or precipitate from such aqueous based compositions” [0033]. To overcome the poor water solubility of Dapsone, Lathrop employs a solvation medium [0034] which comprises an organic solvent such as diethylene glycol monoethyl ether (ethoxydiglycol) [0055-56] and an oil phase compound such as isopropyl myristate [0063]. Lathrop discloses that “[a]ccording to the invention, the emulsifier system includes at least a fatty alcohol and a surfactant” [0068]. Lathrop discloses suitable surfactants include polyoxyethylene sorbitan esters, e.g., polysorbate 20 or Tween 20 [0070] but that commercial blends are available [0076]. One such blend it sold as Crodafos CES which is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate [0077]. Lathrop also discloses that “[a]ccording to the invention, a preferred range for the concentration of Crodafos CES as the emulsifier system of the present invention is from 1 percent to 20 percent by weight” [0078].
Tamarkin ‘414 and Lathrop do not discloses the specific propellant blend instantly claimed.
Tamarkin ‘029 relates to foamable pharmaceutical and cosmetic compositions with potentially enhanced skin delivery [abstract]. Tamarkin ‘029 also discloses that “suitable propellants include volatile hydrocarbons such as butane, propane, isobutane and fluorocarbon gases, or mixtures thereof. In an embodiment the propellant is AP70 which is a mixture of propane, isobutene and butane” [00247-248].
AP70 is Propane/Iso-Butane/N-Butane at a ratio of 55:15:30, as evidenced by HARP AP70 [Component].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have simply substituted the polysorbate 20 (Tween 20) of Tamarkin ‘414 with the blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate disclosed by Lathrop. One would have been motivated to make this substitution because Lathrop teaches cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate is the preferred blend. On would have has an expectation of success because Lathrop discloses it is useful for emulsions comprising poorly water soluble actives which use diethylene glycol monoethyl ether to enhance delivery and comprise an oil phase such as isopropyl myristate. Additionally, Lathrop teaches that surfactants such as Tween 20 are equivalent to the surfactants in the blend cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate, while Tamarkin discloses the foam may comprise cetearyl alcohol. The skilled artisan would have been motivated to have substituted the surfactant blend of Lathrop in place of the surfactants of Tamarkin ‘414 for stabilizing the emulsion with a reasonable expectation of success. The simple substitution of one known element (e.g., the surfactant blend of Lathrop) in place of another (e.g., the surfactants of Tamarkin ‘414) in order to achieve predictable results (stabilized emulsion) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected AP-70 as the propellant desired by Tamarkin ‘414 because Tamarkin ‘029 discloses it is suitable as a propellant for topical foams.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed ranges for the emulsifier blend (2-5% w/w and 2%w/w; instant claims 1 and 11), diethylene glycol monoethyl ether (10-35% and 25-35%w/w; instant claims 1 and 7) and ratio of propellant to emulsion (1:8 to 1:6; instant claim 1) overlap with the ranges of the prior art for the emulsifier blend (1-5% w/w), diethylene glycol monoethyl ether (2-30% w/w) and the ratio of propellant to emulsion (1:32.33 to 1:4.5). Therefore, a prima facie case of obviousness exists for each range.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated an aerosol foam comprising an oil in water emulsion that contains active agents (ketoconazole), diethylene glycol monoethyl ether, and an emulsifier blend consisting of cetearyl alcohol, dicetyl phosphate, and ceteareth-10 phosphate wherein each component was present within the instant claimed amounts. Wherein the foam is produced using a propellant blend consisting of propane/isobutane/butane at a ratio of 55:15:30 and where the ratio of propellant to the oil in water emulsion is about 1:8 to 1:6.
Regarding instant claim 2, Tamarkin ‘414 does not disclose a specific viscosity.
Tamarkin ‘029 discloses that “the viscosity of the composition, prior to filling of the composition into aerosol canisters, is about or less than 12,000 CPs, and more preferably, less than 10,000 CPs” [0157].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected a viscosity less than 12000 CPs because Tamarkin ‘029 discloses that range is suitable for emulsions used in topical aerosol foams. In selecting this viscosity, the viscosity of the composition taught by the prior art overlaps with the instantly claimed range and so a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding instant claim 4, Tamarkin discloses the foam “breaks under sheer force” [0175].
The foams of Tamarkin ‘414 are within the scope of the claim 4 because the instant specification discloses one of three causes of foam collapse may be “mechanical pressure (pushing) on the foam during rub-in” [instant specification, p. 4, lines 1]. Thus breaking (i.e., collapsing) the foam under sheer force, as taught by Tamarkin ‘414, is within the scope of collapsing after discharge, as instantly claimed.
Regarding instant claim 6, Tamarkin ‘414 discloses that “[i]n the context of the present invention, a therapeutic enhancer is a material that facilitates an enhanced delivery of an active agent into a target site of treatment, thus enabling an improved therapeutic effect. Suitable therapeutic enhancers include polyhydric alcohols having at least two hydroxy groups” [0072]. Specific examples include propylene glycol and butylene glycol [0073].
Tamarkin ‘414 does not disclose hexylene glycol.
Lathrop discloses that, in addition to glycol ethers, polyols such as propylene glycol, butylene glycol and hexylene glycol are useful solvents [0058]. According to Lathrop these solvents contribute to a solvation medium [0055] which is what is responsible for dissolving the poorly water soluble drug, Dapsone (i.e., facilitates enhanced drug delivery) [0010].
Tamarkin ‘029 discloses examples of skin penetration enhancers include polyols such as hexylene glycol [0236].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have simply substituted the propylene glycol or butylene glycol of Tamarkin ‘414 of the hexylene glycol of Lathrop. One would have been motivated to make this substitution because one would have appreciated that hexylene glycol is ‘therapeutic enhancer’ as Tamarkin ‘414 desires, insofar as it is known to solubilize poorly water soluble actives and enhance active agent penetration. One would have had an expectation of success because hexylene glycol is within the scope of polyhydric alcohols desired by Tamarkin ‘414, and Lathrop discloses hexylene glycol is an appropriate addition to glycol ethers. The skilled artisan would have been motivated to have substituted the hexylene glycol of Lathrop in place of the propylene glycol of Tamarkin ‘414 to enhance delivery of an active with a reasonable expectation of success. The simple substitution of one known element (e.g., the hexylene glycol of Lathrop) in place of another (e.g., the propylene glycol of Tamarkin ‘414) in order to achieve predictable results (enhanced delivery) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition, as taught above, to further comprise hexylene glycol.
Regarding instant claim 12, Tamarkin ‘414 does not disclose a specific range for water. However, Tamarkin ‘414 does exemplify water in amounts from 52.1% w/w [210] to 75.1 % w/w (see The third composition in Example 5, third formulation down in [0213]).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case the instantly claimed range for water (55-70%w/w) overlaps with the range of the prior art and so a prima facie case of obviousness exists.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Tamarkin ‘414 (US 2005/0074414 A1, publication date 04/07/2005) in view of Lathrop et al. (US 2006/0204526 A1, publication date 09/14/2006) and Tamarkin ‘029 (US 2009/0130029 A1, publication date 05/21/2009), as evidenced by HARP AP70 (HARP International, HARP AP70 Product Specification, June 2014; previously cited) as applied to claims 1, 2, 4, 6, 7, 11, 12, and 26 above, and further in view of Andres et al. (WO 2009/056754 A2, publication date 05/07/2009; citing English machine translation).
Tamarkin ‘414, Lathrop and Tamarkin ‘029, which are taught above, differ from the instant claims insofar as they do not teach econazole nitrate. Tamarkin ‘414, does however, disclose the active agent may be azoles [p. 15, claim 30] and may be an anti-acne active agent [p. 16, claim 46].
Andres discloses a composition for treating acne comprising econazole or salts thereof [abstract]. Andres discloses that econazole nitrate is preferred [p. 4, penultimate paragraph] and that the composition may be delivered as an aerosol foam [p. 6, para. 4].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the econazole nitrate of Andres with the composition taught by Tamarkin ‘414, Lathrop and Tamarkin ‘029. One would have been motivated to make this combination because Tamarkin desires an anti-acne active agent. One would have had an expectation of success because Andres discloses econazole nitrate may be formulated in an aerosol foam. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated an aerosol foam, as taught above, wherein the active agent is econazole nitrate.
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Tamarkin ‘414 (US 2005/0074414 A1, publication date 04/07/2005) in view of Lathrop et al. (US 2006/0204526 A1, publication date 09/14/2006) and Tamarkin ‘029 (US 2009/0130029 A1, publication date 05/21/2009), as evidenced by HARP AP70 (HARP International, HARP AP70 Product Specification, June 2014) as applied to claims 1, 2, 4, 6, 7, 11, 12, and 26 above, and further in view of Kisak et al. (US 2013/0337031 A1, publication date 12/19/2013; previously cited) and Shinde et al. (Indo American Journal of Pharmaceutical Research, 2013, vol. 3, issue 12, p. 1322-1327; previously cited).
Tamarkin ‘414, Lathrop and Tamarkin ‘029, which are taught above, differ from the instant claims insofar as they do not teach ivermectin and oxymetazoline free base. However, Tamarkin ‘414 is directed to a foam having enhanced skin penetration [abstract].
Kisak discloses a topical formulation for the transdermal delivery pharmaceutically active agents [abstract and 0062] such as oxymetazoline (i.e., oxymetazoline free base) [0069] or ivermectin [0141] which may be formulated as a foam [0056]. Kisak also discloses “[t]ransdermal drug administration is difficult since skin is an excellent diffusion barrier” [0003]. As a result, “[d]elivering an active agent into or through the skin in sufficient concentrations often requires some means for reducing the stratum corneum' s hindrance of penetration” [0005]. However, many chemical penetration enhancers “are irritating to the cells of the epidermis which can limit both the choice and concentration of MPE™s [chemical penetration enhancers] suitable for topical formulations” [0007].
Shinde discloses “[f]oams in general may be associated with enhanced drug penetration due to their unique nature” [p. 1324, penultimate paragraph].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated the foam composition taught by Tamarkin ‘414, Lathrop and Tamarkin ‘029 with ivermectin or oxymetazoline free base as the active agent. One would have been motivated to formulate ivermectin or oxymetazoline as a foam because foam formulations were known to enhance drug penetration, according to Shinde. One would have been motivated to use the foam formulation disclosed by Tamarkin ‘414, Lathrop and Tamarkin ‘029 because they are specifically directed to foams with enhanced skin penetration, which Kisak desires for pharmaceutical actives such as ivermectin and oxymetazoline (oxymetazoline free base). One also would have had an expectation of success because Kisak discloses ivermectin and oxymetazoline may be formulated in topical foam compositions. Additionally, in substituting the ivermectin or oxymetazoline for the active agents of Tamarkin ‘414 one would have expected nothing more than predictable results because, once substituted, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale B.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated the topical aerosol foam composition taught by Tamarkin ‘414, Lathrop and Tamarkin ‘029, with either ivermectin or oxymetazoline free base as the active agent.
Response to Arguments
1) On pages 5 and 6 of their remarks, Applicant argues the it would not have been prima facie obvious to select ketoconazole or econazole because “[t]here are hundreds of specific drugs mentioned in Gupta, with no guidance toward ketoconazole or econazole over any others” [Remarks, p. 5, last para.].
This argument is moot in view of the new rejections.
2) On page 6 of their remarks, applicant argues there is no motivation “for why the skilled artisan would combine ketoconazole or econazole (from the hundreds of disclosed active ingredients in Gupta) and a foam delivery system (from the over forty disclosed delivery system options)” [Remarks, p. 6, para. 2].
This argument is moot in view of the new rejections.
3) On pages 6 and 7 of their remarks, Applicant argues a prima facie case of obviousness cannot be established because Gupta does not expressly disclose diethylene glycol monoethyl ether and fails to teach a foam comprising the claimed emulsifier blend.
This argument is moot in view of the new rejections.
4) On page 7 of their remarks, Applicant argues that the fact that AP70 is a commercially available propellant fails to provide a reasonable expectation of success.
This argument is moot in view of the new rejections.
5) At paragraph 2 on page 8 of their remark, Applicant argues that the claimed propellant blend, emulsifier and active ingredient unexpectedly produce acceptable foams. Applicant cites examples 6-11 and Tables 13-17 to support the assertion of unexpected results.
This argument is not persuasive. Example 6 provides four foam formulations for each of the non-roflumilast active agents. These formulations specify proportions of propellant blend, emulsifier blends and active ingredients that produce acceptable foams. Example 6 does not disclose what makes these unexpected/surprising results, or what results one would have expected. Similarly Examples 10 and 11 do not indicate any unexpected results. In fact, Example 11 recites: “A wide range of foam structures were observed for the different formulations showcasing the range of foams which can be produced using the tested APIs. The foam structures can be optimized for specific indications” [Instant Specification, p. 47, lines 9-12]. This does not illustrate an unexpected result but an optimizable parameter. Additionally, the formulations of Tables 13-17 all comprise the same propellant (AP70) at the same ratio of propellant to concentrate of 1:8 so it is not clear what role this limitations would play on the formation of an acceptable foam which applicant alleges is unexpected.
Furthermore, overcoming a rejection based on unexpected results requires the combination of three different elements: the results must fairly compare with the prior art, the claims must be commensurate in scope, and the results must truly be unexpected. MPEP §716.02. The burden rests with Applicant to establish results are unexpected and significant. MPEP §716.02(b). Applicant's showing of allegedly unexpected results does not satisfy any of these requirements.
First, The alleged unexpected results have not been compared to the closest prior art. It appears that the closest prior art is the second formulation of Example 5 [0213] as disclosed by Tamarkin ‘414. MPEP 716.02(e).
Second, to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). (MPEP 716.02(d)). In the present case applicant has not provided results for formulations comprising the emulsifier blend in amounts lower than the claimed 2% w/w. Additionally, Applicant has not provided results for compositions comprising the claimed amount of emulsifier blend when the active agent is econazole nitrate or oxymetazoline free base. Similarly, applicant has not provided results for compositions above the claimed amount of emulsifier blend when active agent is ketoconazole or ivermectin. With respect to proportion of propellant blend and active agent, applicant has not provided results from compositions with varied amounts of propellant blend and active agent.
Finally, the claims are not commensurate in scope with the showing of evidence. The evidence demonstrates acceptable foams only at ratios of 1:8 propellant to emulsion, not at ratios of 1:8 to 1:6 as instantly claimed. The evidence demonstrates acceptable foams only at once concentration of active agent, the claims do not recite a concentration of active agent. The evidence only demonstrates acceptable foams comprising 10% w/w emulsifier blend when the active agent is econazole nitrate or oxymetazoline free base, the claims do not recite 10% w/w emulsifier blend.
5) On page 8 of their remarks, Applicant argues that the propellant blend provided unexpected results. Applicant cites Table 7 for support.
Table 7 recites water solubility data. Table 6 discloses foams comprising different commercially available propellant blends. Thus the examiner respectfully submits Table 7 was a typo and will look to Table 6 for support.
This argument is not persuasive. To begin, the instant specification does not appear to acknowledge these results as unexpected. Additionally, these results have not been compared to the closes prior art. It appears the propellant blend of the closest prior art (Tamarkin ‘414) is, by the examiners reading, a propane/n-butane blend (see Examples starting at [0210]). The Examiner acknowledges that applicant has provided results for a propane/isobutane blend, however given the instant specification discloses that acceptable foams may be generated with the addition of n-butane to a propane/isobutane blend, it is not clear what results a blend of n-butane/propane would provide (see p. 22, Table 6, Second and Fourth rows). MPEP 716.02(e).
Additionally, the burden is on applicant to establish that the results are in fact really unexpected and of statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992). See also MPEP § 716.02. In the present case, AP-70, a propellant with the claimed ratio of propane, n-butane and isobutane, was disclosed by Tamarkin ‘029 to be a suitable propellant for topical aerosol foams (see paragraph 347 of Tamarkin ‘029). Considering this disclosure, it is not entirely clear why the formation of an acceptable foam with the propellant blend of AP-70 would have been unexpected. While the Examiner appreciates that other propellants did not produce acceptable foams, given the disclosure of Tamarkin ‘029 the Examiner respectfully notes that one of ordinary skill in the art would have expected the AP-70 propellant to have produced an acceptable topical aerosol foam.
Finally, the compositions of Table 6 comprise roflumilast as the active agent. Considering roflumilast is specifically excluded from the claimed compositions these results cannot be commensurate in scope with the claims. Additionally, the claims are not commensurate in scope because the evidence only provides results for one concentration of the emulsifier blend and one concentration of the diethylene glycol monoethyl ether while the claims recited a concentration range for each. The "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)).
6) On page 9 of their remarks, Applicant argues the additions of Kisak and Shinde do nothing to address the defects noted above.
This argument is moot in view of the new rejections.
Conclusion
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612