DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 23, 2026 has been entered.
Claims 1, 3-10, 13-21 are pending. Claims 1, and 3-6, herein acted on the merits.
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 .
Priority
This Application filed on 07/22/2022 is a CON of PCT/EP2021/051478 filed on 01/22/2021 which has PRO 62/964,516 filed on 01/22/2020, PRO 62/964,495 filed on 01/22/2020, and PRO 62/964,507 filed on 01/22/2020.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 102(a)(1) rejection of claim 12 over Ibuki et al. (US6673808B1) is persuasive in view cancellation of claims. The rejection is withdrawn.
Applicant’s arguments over the 35 U.S.C. 102(a)(1) rejection of claim 12 over Ueda et al. (US20040220204A1) is persuasive in view cancellation of claims. The rejection is withdrawn.
Applicant’s arguments over the 35 U.S.C. 102(a)(1) rejection of claim 12 over Kriwet et al. (US20050220850A1) is persuasive in view cancellation of claims. The rejection is withdrawn.
Applicant’s arguments over the 35 U.S.C. 103 rejection of claims 1, 3-6 over Mallard1 et al. (WO 2020064843 A1) or Mallard2 et al. (WO 2020065085 A1) or Mallard3 et al. (WO 2020064843 A1) or Mallard4 et al. (WO 2020065085 A1), as applied to claims 1-2 and 6 above is not persuasive. Applicant argues “While the Mallard references list pimecrolimus and efinaconazole among dozens of possible active ingredients, the references do not specifically teach, suggest, or exemplify a composition containing both a macrolide immunosuppressant (pimecrolimus, sirolimus, or tacrolimus) and efinaconazole together. The preferred actives in Mallard are "adapalene, benzoyl peroxide, brimonidine, ivermectin, resiquimod." See Mallard1, page 10. Neither pimecrolimus nor efinaconazole appears in these preferred lists.”
In response, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant' s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." Id. at 554, 31 USPQ2d at 1132.). Furthermore, "[t]he prior art' s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Applicant respectfully submits that the specification contains comparative stability data demonstrating unexpected mutual stabilization between macrolide immunosuppressants and efinaconazole, data which is unexpected and unpredictable in light of the cited art. Applicant then points to examples 2-4 and 6, wherein the combination is argued to have improvement in stability and degradation.
In response. Applicant’s arguments do not commensurate in scope with the claims – specifically, Applicant’s claims do not recite the specific amounts of the comparative examples, i.e. 0.9% w/w pimecrolimus. Further, Examiner requests Applicant’s clarification as to why not a single efinaconazole- only formulation is used for comparison purposes, i.e. of stability and degradation. The arguments are not persuasive.
The rejections are as below:
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.
Claims 1, 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mallard1 et al. (WO 2020064843 A1) or Mallard2 et al. (WO 2020065085 A1) or Mallard3 et al. (WO 2020064843 A1) or Mallard4 et al. (WO 2020065085 A1).
Mallard1 et al. teaches a composition in the form of a water-in-oil (W/O) emulsion comprising pharmaceutically active ingredient is selected from among pimecrolimus efinaconazole and salts or derivatives of these active ingredients, taken alone or in a mixture.
Mallard2 et al. teaches a composition in the form of a water-in-oil (W/O) emulsion comprising pharmaceutically active ingredient is selected from among pimecrolimus efinaconazole and salts or derivatives of these active ingredients, taken alone or in a mixture.
Mallard3 et al. teaches a composition in the form of a water-in-oil (W/O) emulsion comprising pharmaceutically active ingredient is selected from among pimecrolimus efinaconazole and salts or derivatives of these active ingredients, taken alone or in a mixture.
Mallard4 et al. teaches a composition in the form of a water-in-oil (W/O) emulsion comprising pharmaceutically active ingredient is selected from among pimecrolimus efinaconazole and salts or derivatives of these active ingredients, taken alone or in a mixture.
While the examples of Mallard1-4 teach actives in amounts such as 3% w/w or 0.5% w/w, the prior art does not exemplify the amount combination of pimecrolimus and efinaconazole.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify amounts of the actives, as claimed. 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). (MPEP § 2144.05(Il)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). Therefore, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Conclusion
No claims are allowed.
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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622
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