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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/8/20 was submitted in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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.
Claim(s) 8-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Lindahl et al (WO 2012/107565 A1 hereafter Lindahl) in view of Friden et al (WO 2008/121709 A1 hereafter Friden)
Lindahl discloses a pharmaceutical composition comprising an allylamine antifungal at least 5% [0016]. Preferably the antifungal is terbinafine present from 10.5-11.5% [0019]. The composition further comprises an organic acid such as lactic acid present about 8-20% [0021-0023]. The formulation further comprises a diol present at least 50%, such as propanediol [0024-0025]. The formulation further comprise a sequestering agent such as EDTA present from 0.01-5% [0028]. The formulation further comprises urea present about 10% [Table 2]. This formulation is water-free [0010, 0014].
While the formulation comprises an antifungal formulation, comprising common carriers such as an organic acid, diol and chelating agents, the reference is silent to solubilizers or permeation enhancers. However the formulation measures skin permeation and monoalcohols are known as solubilizers of antifungal compounds that improve penetration. This can be seen in the Friden patent.
Friden discloses a topical formulation comprising a monoalcohol as a solvent such as ethanol (pg. 10, 20-25). The solvent is present about 10-50% (Table A). The formulation further comprises permeation enhancers about 10% (pg. 10, lin. 10-15). The formulation is antifungal and comprises about 6-10% terbinafine ((pg. 7, lin. 13-23, pg. 13, lin. 15-20). The formulation further comprises a chelating agent such as EDTA present up to 0.1% (Table A). The formulation is water-free (Table A). It would have been obvious to include the solubilizing ethanol into the formulation of Lindahl in order to improve the solubility of the anti-fungal compound and improve the permeation of the drug into the skin.
Regarding the ranges and concentrations of the instant claims, it is the position of the Examiner that such limitations do not distinguish over the prior art. The general conditions of the claims have been met by the combination of Lindahl and Friden discloses a pharmaceutical formulation comprising the same antifungal compound and supporting carrier system comprising the same, diol, organic acid , monoalcohol and chelating agents, present in similar concentrations to those of the instant claims. 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. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable topical antifungal formulation. It would have been obvious to combine the components of the Friden into the similar anhydrous formulation of Lindahl, as including an extra solvent would improve the solubility of the drug and thereby improve the penetration of the compound in the skin. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable antifungal formulation useful in iterating fungal infections.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618