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 .
Applicants’ arguments, filed 06/29/2026, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn.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 – New by Amendment
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.
1) Claim(s) 1, 4, 6, 11, 12 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Dhuppad et al. (WO 2017 /191532 A1, publication date 09/11/2017) in view of Kaoukhov et al. (US 2008/0139488 A1, publication date 06/12/2008).
Dhuppad “relates to azelaic acid foam compositions comprising surfactants, a hydrophobic base, solvent and a propellant, which upon release from the aerosol container forms a stable foam product. The invention also relates to topical or mucosal administration of foamable compositions in treating dermatological disorders such as rosacea” [abstract]. Dhuppad discloses that “[s]uch a composition creates an oil-in-water emulsion that is stable and upon release from the aerosol container” (i.e., oil-in-water-emulsion aerosol foam comprising a solvent) [p. 2, lines 17-18]. “In one or more embodiment there is provided a foamable composition wherein surfactant is a combination product” such as Crodafos CES (i.e., cetearyl alcohol, dicetyl phosphate and ceteareth-10 phosphate according to the instant specification at page 17, Table 2) [p. 7, lines 13-14 and 16]. “Hydrocarbon propellants are selected from the group consisting of butane, iso-butane, propane, pentane, and mixtures thereof” (i.e., propellant blend) and “are present in amount from about 2% to about 10%” (i.e., 1:49-1:9 propellant to emulsion ratio) [p. 10, lines 15-18]. Dhuppad does not disclose roflumilast.
Dhuppad differs from the instant claims insofar as it does not disclose the instantly claimed propellant to emulsion ratio and does not disclose ivermectin.
Kaoukhov discloses that azelaic acid and ivermectin are known to treat rosacea separately [0015-0021], but that “these treatments have drawbacks such as irritation and intolerance phenomena, especially when they are administered for a prolonged period. Furthermore, these treatments are only suppressive and not curative, acting especially on the pustulous spasms occurring during the inflammatory stage” [0022]. “Considering the chronic nature of rosacea, the ideal treatment requires prolonged use, in a safe and effective manner. Taking the foregoing into account, there is thus a need for a composition that shows improved efficacy in the treatment of rosacea and that does not exhibit the side effects described in the prior art” [0023]. Accordingly, Kaoukhov “features compositions comprising a combination of at least one compound of the avermectin family and azelaic acid, which are useful for treating rosacea” [0024] preferably ivermectin and azelaic acid [0029]. Kaoukhov discloses acceptable carries include emulsions [p. 3, claim 10].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the ivermectin of Kaoukhov with the azelaic acid compositions taught by Dhuppad. One would have been motivated to make this combination because Kaoukhov teaches that the combination of ivermectin and azelaic acid address the drawbacks of the single active prior art compositions. One would have had an expectation of success because Kaoukhov discloses ivermectin and azelaic acid may be combined in emulsions while Dhuppad discloses emulsions comprising azelaic acid. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
MPEP 2144.05(I) states “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” In the present case, both the prior art and the instant claims combine the emulsion and the propellant to form an aerosol foam for topical delivery of an active. Consequently, a skilled artisan would have expected the ratio of propellant to emulsion taught by the prior art (e.g., 1:9) to result in the same properties as the instantly claimed propellant to emulsion ratio (e.g., 1:8) because the ratios are so close, and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated an aerosol emulsion comprising an oil in water emulsion comprising ivermectin, cetearyl alcohol, dicetyl phosphate, ceteareth-10 phosphate, a solvent, a propellant blend present as instantly claimed and not roflumilast.
Regarding instant claim 4, Dhuppad discloses “a method of skin or mucosal surface application comprising spreading or collapsing a stable foam by mechanical force at the target site of a subject” [p. 13, lines 4-6].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have collapsed the foams taught by Dhuppad and Kaoukhov after application to skin because Dhuppad discloses that is a suitable method for application of the topical foams. See MPEP 2143, Exemplary Rationale A. Collapsing a foam by mechanical force reads on instant claim 4 because the foam of the prior art collapses after application to a subject’s skin.
Dhuppad discloses the composition may comprise hexylene glycol [p. 21, lines 22], as per instant claim 6.
Regarding instant claims 11, 12 and 26, Dhuppad discloses the amount of “surfactants used in the present invention is from about 0.1 % to about 10%” [p. 7, line 19]. Dhuppad also discloses that the emulsions may “further includes hydrophilic component selected from […] water” [p. 10, lines 1-2] which may be present in amounts from 80-50% [p. 10, lines 9-11].
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 emulsifier blend (i.e., 2% w/w and 2-5% w/w; instant claims 11 and 26, respectively) and water (i.e., 55-70% w/w; instant claim 12) overlap with the ranges of the prior art for surfactants (i.e., 0.1-10%) and water (i.e., 50-80%) and so a prima facie case of obviousness exists for each range.
2) Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dhuppad et al. (WO 2017 /191532 A1, publication date 09/11/2017) in view of Kaoukhov et al. (US 2008/0139488 A1, publication date 06/12/2008) as applied to claims 1, 4, 6, 11, 12 and 26 above, and further in view of Tamarkin ‘029 (US 2009/0130029 A1, publication date 05/21/2009; previously cited).
Dhuppad and Kaoukhov, which are taught above, differ from the instant claims insofar as they do not teach the viscosity of the emulsion.
Tamarkin ‘029 relates to foamable compositions for enhanced skin delivery of pharmaceuticals [abstract]. Tamarkin ‘029 teaches 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, before the effective filling date of the claimed invention, to have formulated the emulsion taught by Dhuppad and Kaoukhov to have a viscosity less than 10,000 cPs because Tamarkin ‘029 discloses that a viscosity of less than 10,000 cPs is suitable for emulsions for topical aerosol foams.
Additionally, the range of the prior art of less than 10,000 cps overlaps with the range of the instant claims 4,000-10,000 cps, and so a prima facie case of obviousness exists. See MPEP 2144.05(I).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition taught by Dhuppad and Kaoukhov, as discussed above, to have a viscosity as instantly claimed.
3) Claim(s) 7, 27 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dhuppad et al. (WO 2017 /191532 A1, publication date 09/11/2017) in view of Kaoukhov et al. (US 2008/0139488 A1, publication date 06/12/2008) as applied to claims 1, 4, 6, 11, 12 and 26 above, and further in view of Tamarkin ‘029 (US 2009/0130029 A1, publication date 05/21/2009; previously cited) and Sutton et al. (Journal of Cosmetics, Dermatological Sciences and Applications, 2018, 8, p. 207-217).
Dhuppad and Kaoukhov, which are taught above, differ from the instant claims insofar as they do not teach diethylene glycol monoethyl ether.
Dhuppad also discloses that the emulsions may “further includes hydrophilic component selected from dimethyl isosorbide” [p. 10, lines 1-2]. Dhuppad also discloses desires surfactants such as Crodafos CES [p. 7, lines 13-14 and 16].
Tamarkin ‘029 relates to foamable compositions for enhanced skin delivery of pharmaceuticals [abstract]. Tamarkin ‘029 discloses “the foamable composition includes a potent solvent, in addition to or in place of one of the hydrophobic solvents, polar solvents or emollients of the composition” (i.e., additional polar solvent) [0238]. According to Tamarkin ‘029 a “non-limiting exemplary list of solvents that can be considered as potent solvents includes […] isosorbide derivatives, such as dimethyl isosorbide, glycofurol and ethoxydiglycol (transcutol)” (i.e., diethylene glycol monoethyl ether) [0241].
Sutton relates to oil-in-water emulsion for topical delivery of an active pharmaceutical ingredient [title & abstract]. Sutton discloses that “moisturizing cream containing 25 wt% of an organic solvent, diethylene glycol monoethyl ether (DEGEE), is observed to be stabilized by an emulsifying wax blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate (tradename Crodafos CES)” [abstract]. Sutton also discloses “[t]he superior solubilizing properties of DEGEE combined with the full pH range and liquid-crystal stabilizing properties of the Crodafos CES give this formulation the potential for a wide range of applications in the topical delivery of active pharmaceutical ingredients” [abstract]. Transcutol is diethylene glycol monoethyl ether (DEGEE) (see page 216, third reference listed).
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have used diethylene glycol monoethyl ether of Tamarkin ‘029 and Sutton in place of the dimethyl isosorbide of Dhuppad. One would have been motivated to make this substitution for the stabilizing effects and solubilizing properties disclosed by Sutton. One would have had an expectation of success because Tamarkin ‘029 discloses diethylene glycol monoethyl ether and dimethyl isosorbide are both suitable polar solvents for emulsion based topical aerosol foams. The simple substitution of one known element (e.g., the diethylene glycol monoethyl ether of Tamarkin ‘029 and Sutton) in place of another (e.g., the dimethyl isosorbide of Dhuppad) in order to achieve predictable results (hydrophilic solvent) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have added the diethylene glycol monoethyl ether to the emulsion in an amount of 25% w/w because Sutton discloses 25% w/w diethylene glycol monoethyl ether stabilizes emulsion comprising Crodafos CES. See MPEP 2144.07.
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 of diethylene glycol monoethyl ether (25-35% w/w and 10-35%w/w; instant claims 7 and 28) overlap with the amount of the prior art and so a prima facie case of obviousness exists for each range.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the aerosol foam taught by Dhuppad and Kaoukhov, as discussed above, to further comprise diethylene glycol monoethyl ether in an amount within the instantly claimed ranges.
4) Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dhuppad et al. (WO 2017 /191532 A1, publication date 09/11/2017) in view of Kaoukhov et al. (US 2008/0139488 A1, publication date 06/12/2008), Tamarkin ‘029 (US 2009/0130029 A1, publication date 05/21/2009) and Sutton et al. (Journal of Cosmetics, Dermatological Sciences and Applications, 2018, 8, p. 207-217) as applied to claims 1, 4, 6, 11, 12 and 26-28 above, and further in view of Renock et al. (US 2018/0110694 A1, publication date 04/26/2018), as evidenced by DiversifiedCPC (NIP-Blends, DiversifiedCPC, 2026 [retrieved 08/15/2026]).
Dhuppad, Kaoukhov, Tamarkin ‘029 and Sutton, which are taught above, differ from the instant claims insofar as they do not teach the instantly claimed propellant blend. Dhuppad does disclose that “propellants are selected from the group consisting of butane, iso-butane, propane, pentane, and mixtures thereof” [p. 10, lines 15-18].
Renock relates to aerosol foams for topical application [title & abstract] for the delivery of antimicrobial actives, such as azelaic acid [0199]. According to Renock “foaming agent/propellant which may be employed in the hair care composition of the present invention may include the chemically-inert hydrocarbons such as propane, n-butane, isobutane, n-pentane, isopentane, and mixtures thereof” such as NIP-70 [0184].
NIP-70 has the molar ratio of propane:isobutane:n-butane of 54.69:15.14:27.17, as evidenced by DiversifiedCPC.
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, before the effective filling date of the claimed invention, to have selected the NIP-70 of Renock for the propellant mixture desired by Dhuppad because Renock discloses NIP-70 is a suitable propellant for topical aerosol foams comprising azelaic acid.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the topical aerosol foam taught by Dhuppad, Kaoukhov, Tamarkin ‘029 and Sutton, as discussed above, wherein the propellant is consists of propane, isobutane and n-butane in a molar ratio of 54.69:15.14:27.17.
Response to Arguments
1) On pages 6-8 of their Remarks, Applicant argues that a skilled artisan would not have combined the teachings Tamarkin ‘414, Lanthrop, Tamarkin ‘029 and Kisak as discussed in the previous Office Action on pages 4-6 and 14.
This argument is moot in view of the new rejections necessitated by amendment.
2) On page 7 of their Remarks, Applicant argues the selection of the instantly claimed propellant blend is not prima facie obvious because some commercially available propellants did not produce suitable foams, as evidenced by Tables 13-17 of the instant specification.
The Examiner respectfully disagrees. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) MPEP 2144.07. In the absence of unexpected results the rejection is maintained as discussed above and in response #3 directly below. A skilled artisan would have expected NIP-70 to produce a suitable foam in view of Renock disclosing that NIP-70 is a suitable propellant for topical aerosol foams at paragraph [0184].
3) On pages 8 and 9 of their Remarks, Applicant argues the presently claimed composition is unexpectedly able to form an aerosol foam and that that several different propellants, including some of those disclosed in the cited, produced a commercially unacceptable foam product. Applicant cites Table 13.
This argument is not persuasive. As noted above, a skilled artisan would have expected NIP-70 to produce a suitable foam in view of Renock disclosing that NIP-70 is a suitable propellant for topical aerosol foams at paragraph [0184].
Furthermore, 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 or above 10% w/w when active agent is ivermectin. With respect to proportion of propellant blend to emulsion, applicant has not provided results from compositions with varied amounts of propellant blend. Additionally, applicant has not provided examples comprising ivermectin wherein the propellant blend is anything other than NIP-70. Furthermore, it appears that all formulations comprising ivermectin produced acceptable foams (see the Table on pages 47-49).
Accordingly, the Examiner is not able to determine if the claimed ranges and the claimed propellant blends are truly critical to the function of the invention.
Finally, 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)). 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 one concentration of active agent and certain concentrations of emulsifier blend, the independent claim does not recite a concentration of either. Additionally, the independent claim does not recite the propellant blend.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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