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 .
Status of Claims
Claims 1-15 are rejected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/17/2025 is being considered by the examiner.
Priority
The instant application, filed 03 March 2025, is a provisional application of 63/561052, filed 04 March 2024, which claims the benefit of an earlier filing date to U.S. Provisional Patent Application Serial No. 69/561052, filed 04 March 2024. Acknowledgement is made of Applicant’s claim.
Claim Interpretation
Claim 1 contains intended use language: “… for treating eczema”, according to MPRP section 2111.02, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended sue of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” Therefore, “for treating eczema” is not given patentable weight in product claims.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over CRUTCHLEY (US 2022/0110868 A1, published 14 April 2022) in view of FIUME (11 October 2012, International Journal of Toxicology, 31(5), 245S-260S).
Regarding Claims 1-12 and 15, Crutchley teaches a pharmaceutical composition comprising of a PDE4 inhibitor, crisaborole, in a concentration of 1-5% w/w (p.2, ¶ [0025], lines 1-4), a solubilizer, ethanol or isopropanol, in a concentration of less than 10% w/w (p.3. ¶ [0028], lines 6-14), a carbomer in concentration 0.05-5.0% w/w (p.4, ¶ [0051], lines 1-10; p.4 ¶ [0052], lines 1-4), a preservative found to be effective and useful present in an amount from 0.1-1% w/w (p.5, ¶ [0053], lines 1-14], and a suitable acid or base to have the pH of the composition to about 4-6.5 (p.5, ¶ [0055], lines 1-8, and lines 14-15). Crutchley also teaches that the composition of the present invention being dispersible in water, preferably being dilutable within water (p.4, ¶ [0050], lines 1-3).
Crutchley does not teach the compositions inclusion of a humectant.
Fiume teaches the use of propylene glycol as a humectant within cosmetic formulations, where propylene glycol functions as a skin conditioning agent, with some functioning as solvents (p.2, ¶ 8, lines 1-6). In addition to this, Fiume teaches that propylene glycol has been used in 5676 cosmetic formulations at concentrations ranging from 0% to >50% (p.2, ¶ 9, lines 4-5). Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Fiume would have found it prima facie obvious to have combined propylene glycol with the teachings of Crutchley to improve the skin conditioning capabilities of the formulation. Thus, A PHOSITA would have been motivated to utilize propylene glycol as an ingredient that further enhances the skin conditioning capabilities of the composition.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over CRUTCHLEY (US 2022/0110868 A1, published 14 April 2022) in view of FIUME (11 October 2012, International Journal of Toxicology, 31(5), 245S-260S) and further in view of DESHPANDE (US 2020/0022931 A1, published 23 January 2020).
In regard to Claims 13 and 14 Crutchley teaches a topical composition comprised of crisaborole and a discontinuous and continuous phase, and teaches of applying the composition to the scalp or other skin surface through hair (p.6, ¶ [0091], lines 1-2).
The combination of Crutchley and Fiume fail to teach a method of application utilizing an applicator.
Deshpande teaches of a pharmaceutical composition for treatment of PDE related disorder and the application of said composition, “administered to a mammal by a topical route… in the form of a cream… with or without an applicator” (Claim 10). In the instant case, the term “applicator” in Deshpande’s teachings was interpreted to mean a sponge, brush or wipe.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Crutchley and Fiume would have found it prima facie obvious to apply a topical composition with or without the use of an applicator. Thus, a PHOSITA would have been motivated to try different applicators to enhance the application of said topical composition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EVAN G. THOMAE whose telephone number is (571)270-7609. The examiner can normally be reached 8:00 am - 4:30 pm.
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/E.G.T./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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