Patent Application 17755556 - ANTI-INFLAMMATORY COMPOUNDS FOR USE IN THE - Rejection

Patent Application 17755556 - ANTI-INFLAMMATORY COMPOUNDS FOR USE IN THE

Title: ANTI-INFLAMMATORY COMPOUNDS FOR USE IN THE TREATMENT OF DERMAL DISORDERS

Application Information

• Invention Title: ANTI-INFLAMMATORY COMPOUNDS FOR USE IN THE TREATMENT OF DERMAL DISORDERS
• Application Number: 17755556
• Submission Date: 2025-04-09T00:00:00.000Z
• Effective Filing Date: 2022-05-02T00:00:00.000Z
• Filing Date: 2022-05-02T00:00:00.000Z
• National Class: 514
• National Sub-Class: 100000
• Examiner Employee Number: 99924
• Art Unit: 1628
• Tech Center: 1600

Rejection Summary

• 102 Rejections: 0
• 103 Rejections: 1

Cited Patents

The following patents were cited in the rejection:

• US 0244470🔗

Office Action Text

    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 .
Currently, claims 1-11 and 23-29 in the claim set filed May 2nd, 2022 are under consideration.
Priority
	Application 17/755,556 filed May 2nd, 2022 is a 371 national stage entry of PCT/IB2020/061043 filed November 23rd, 2020, which claims priority to IN201911047906 filed November 22nd, 2019.
Information Disclosure Statement
	The information disclosure statements filed May 2nd, 2022, January 22nd, 2024, and October 14th, 2024 have been acknowledged and considered.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Young (KR 20170030830A, published March 20nd, 2017), in view of Srigiridhar (US 2016/0244470 A1, published August 25th, 2016), in further view of Poljsak (“Free Radicals and Extrinsic Skin Aging” Dermatology Research and Practice 2012 1 1-4)
	Young is directed to a “composition for external application for skin” (abstract) comprising “esculetin as an active ingredient” (claim 1). The composition is formulated for “skin regeneration, or improving skin wrinkles” (claim 2). The reference clarifies that the “term ‘skin regeneration effect’…refers to the recovery of skin tissue against damage caused by external or internal causes of the skin. Damage due to external causes may include ultraviolet rays, external contaminants, wound, trauma, etc.” (p. 3, machine translation). The reference invention is also directed to “wound healing….psoriasis” (p. 2) and “Inflammatory hair loss” (p. 4). 
	Young does not teach a composition with additional pharmaceutically acceptable excipients. This is rectified by the disclosure of Young which recites that “present invention may contain cosmetically or pharmaceutically acceptable carriers, diluents, adjuvants, coloring agents, stabilizers, and the like for the purpose of facilitating use and handling, Surfactants, oils, moisturizers, alcohols, thickeners, antioxidants, pH adjusting agents, or ultraviolet light blocking agents” (p. 4, machine translation).
Another difference between the instant claimed invention and the primary reference is that Young is silent on the use of triphenylphosonium derivatives of esculetin in their composition. Srigiridhar teaches a “an antioxidant compound” (abstract) comprising a compound of formula 1, 
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(claim 3), which is the genus as the instant claimed formula I of claim 23,
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, wherein:
Reference X = carbon chain of 8,
Z = any halogen, “preferably bromide” (claim 5)
R = H;
It would have been obvious to one of ordinary skill in the art to substituted esculetin for the compounds of Srigiridhar. A person of ordinary skill in the art would have understood from the teachings of Srigiridhar that both compounds are antioxidants and so could be used for the same purpose. See MPEP 2144.06 (II). The skilled artisan would have been motivated to do so to, as Srigiridhar teaches, overcome the “poor bioavailability in vivo” (p. 1, para. 0005) of esculetin. The simultaneously cationic and lipophilic phosphonium handle helps the compounds of formula I be “preferentially taken up by mitochondria…[and] easily permeate through the lipid bilayers” (p. 2, para 0004). The simultaneously cationic and lipophilic phosphonium handle helps the compounds of formula I be “preferentially taken up by mitochondria…[and] easily permeate through the lipid bilayers” (p. 2, para 0004). One would have been motivated to localize the concentration of compounds of Formula I given the teachings of Poljsak, which recites “the greatest damage is within the skin cells, including the damage to dermal mitochondrial DNA” (p.2 ) by UV radiation and endogenous ROS production. It would have been obvious to one of ordinary skill in the art to formulate the compounds of formula (I) with an additional excipient so that the compound could be administered as an ointment or cream, given the lipophilic nature of the compound.
	The skilled artisan would have had a reasonable expectation of success given working examples of the prior art.  Srigiridhar shows that the compounds of formula I – “but not native esculetin” (p. 5, para. 0044) – “abrogates oxidant-induced cell…in human aortic endothelial cells…incubated with H2O2” (p. 5, para. 0044). Young demonstrates esculetin, when formulated with other excipients such as “wax…polyscorbate…liquid paraffin…squalene” (p. 7) successfully “improved the elasticity of human skin” (p. 6). Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding claims 27-29 directed to a kit, please note that nonfunctional descriptive material cannot render nonobvious an invention that would have otherwise been obvious. In re Ngai, **>367 F .3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (combining printed instructions and an old product into a kit will not render the claimed invention nonobvious even if the instructions detail a new use for the product). Cf. In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 404 (Fed. Cir. 1983) (when descriptive material is not functionally related to the substrate, the descriptive material will not distinguish the invention from the prior art in terms of patentability).
Conclusion
Claims 1-11 and 23-29 are not allowed.
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/J.M.L./Examiner, Art Unit 1628                                                                                                                                                                                                        
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628