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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2022/042753, filed09/07/2022, which claims the priority benefit of PRO Application No. 63/242,059, filed 09/09/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/27/2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Claims 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/27/2024.
Applicant's election with traverse of Group I invention, claims 1-8 in the reply filed on 02/27/2024 is acknowledged. The traversal is on the ground(s) that Inoue US2011/0213164 does not disclose or suggest (1) combining the ceramidase inhibitor with exogenous epidermal lipids/ceramides in a single composition (2) replenishing ceramides alongside inhibition, (3) specific wound treatment, or (4) broader "microbial lipase" inhibition beyond ceramidase and that limited to atopic dermatitis via preservation only and does not teach or suggest the synergy obtained by the dual action of ceramidase inhibition+ supplementation with lipid/ceramide.
This is not found persuasive because Group I invention, claims 1-8 are drawn to a composition comprised of (1) an inhibitor of microbial lipase activity; (2) an epidermal lipid, selected from the group consisting of ceramide, phospholipids, sphingolipids, cholesterol, free fatty acids, and triglycerides; and (3) a pharmaceutically acceptable carrier. Inoue discloses a pharmaceutical composition of a ceramidase inhibitor compound of ceramidastin and pharmaceutically acceptable carriers [0087]-[0090]. Inoue also discloses C12-NBD Ceramide (7-nitrobenz-2-oxa-1,3-diazole (NBD)-labeled N-dode-canoylsphinogosine, product of Avanti Polar Lipids) [0129]. Therefore, the limitations of instant claim 1 are met by Inoue.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-4, and 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/27/2024. Applicant elects Ceramidastin as the inhibitor of microbial lipase activity (and specifically as the ceramidase inhibitor); A long-chain dihydroceramide having the general structure of
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recited in claim 6, wherein R = -(CH2)18-29(CH3) (the first of the three R groups defined in claim 6); and pharmaceutically acceptable carrier, wherein the composition is formulated as a cream for topical application.
Status of the Application
Claims 1-17 are pending. New claim 17 has been added. Claims 3-4, 9-16 have been withdrawn from further consideration. Claims 1-2, 5-8, and 17 are examined herein insofar as they read on the elected invention and species.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (pg. 38, lines 22-23). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 5-8, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Inoue (US 2011/0213164 A1) in view of Orita (US 2014/0100276 A1).
The instant claims are directed to a composition of a microbial lipase inhibitor (ceramidastin), epidermal lipid selected from the group consisting of ceramide, phospholipids, sphingolipids, cholesterol, free fatty acids, and triglyceride and a pharmaceutically acceptable carrier.
Inoue et al. teach “[t]hus, a compound that inhibits ceramidase produced by Pseudomonas aeruginosa is expected to prevent a decrease of ceramide and hence prevent aggravation of atopic dermatitis. However, at present, there is no critically useful therapeutic method for atopic dermatitis, although the skin has been maintained clean and/or a steroid drug, a humectant, etc. have been applied for treating atopic dermatitis. Thus, demand has arisen for developments of a new compound having an excellent inhibitory activity against neutral/alkaline ceramidase and a more effective, safe novel therapeutic drug for atopic dermatitis” [0007]. Inoue also teaches the ceramidase inhibitor of ceramidastin as formula (1) [0009]-[0011].
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Inoue’s Formula (1) (Left) Applicant’s ceramidastin (Right)
Inoue discloses a pharmaceutical composition of a ceramidase inhibitor compound of ceramidastin and pharmaceutically acceptable carriers [0087]-[0090]. Inoue also discloses the pharmaceutical composition can inhibit neutral/alkaline ceramidase produced by Pseudomonas aeruginosa, and thus, can be particularly Suitably used as a therapeutic drug for atopic dermatitis [0093]. Inoue discloses the ceramidase inhibitor or pharmaceutical composition dosage form can be a liquid or ointment [0097].
However, Inoue et al. fail to explicitly disclose the elected long-chain dihydroceramide of
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, wherein R = -(CH2)18-29(CH3).
Orita et al. teach D/L ceramides which may be in either optical form or in a mixture of each wherein the compound below is disclosed and is ingredient (C)
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[0044]. Orita’s disclosed compound satisfies the structural limitations of applicant’s elected compound of ceramide where R is a (CH2)21(CH3). Orita discloses “[t]he emulsion composition of the present invention contains, as active ingredients, ingredients (A), (B), and (C) and forms a uniform a structure having high Steric regularity. Thus, the emulsion composition has enhanced water retention and allows water to remain in the skin for a long period of time, whereby the skin conditions can be improved. When the composition is applied to the skin, excellent skin permeability and long-lasting moistness can be obtained. In addition, the composition enables formation on the skin Surface of a soft coating layer having a lamellar-like structure, whereby water can be retained in the interlayer space, to thereby enhance a skin protection effect.” [0017]. Orita discloses glyceryl monostearate as a preferred compound for ingredient (A) [0024]. Orita teaches that emulsion composition is an O/W-type emulsion composition and is suited for producing, cosmetics such as skin lotion, milky lotion, cream, and gel, or an agent for skin external use [0111]. Orita also discloses through observation under a transmission electron microscope (TEM), the coating films produced in examples were found to have a lamellar structure [0113].
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the instant application, to modify the teachings of the ceramidase inhibitor ceramidastin disclosed as an ointment or liquid form for application to the skin taught by Inoue for skin conditions including atopic dermatitis and Pseudomonas aeruginosa with the disclosures of ceramides, and glyceryl monostearate in an emulsion by Orita’s because the lamellar structures in the lotion, milky lotion, cream, and gel, or an agent for skin external use would provide improved bioavailability though prolonged exposure of Inoue’s ceramidastin compound to the skin by improving the duration of active agents available for permeating the skin. See MPEP 2144.05 (II)
A person of ordinary skill in the art would have been motivated to combine the compounds of Inoue’s ceramidastin and Orita’s ceramide emulsion formulation through routine optimization because prolonging the contact of ceramidastin active ingredient to the skin would allow more permeation into the affected area and solve Inoue’s problem of a useful therapeutic method of treating atopic dermatitis to give a person of ordinary skill a reasonable expectation of success.
Conclusion
All claims are rejected, no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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/E.V./Examiner, Art Unit 1623
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
