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 08/25/2023 is a National Stage entry of PCT/US2022/017743, International Filing Date: 02/24/2022. PCT/US2022/017743 Claims Priority from Provisional Application 63154292, filed 02/26/2021.
Status of Claims
Claims 1-19 and 25 are pending as of the response filed on 2/2/26. Claims 20-24 have been canceled.
Applicant’s election of invention II and the species acitretin in the reply filed on 2/2/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicants have stated the elected species reads on claims 1-6, 8, 11-12, and 14-18.
In addition to the elected species, acitretin, search and examination have been carried out to the additional species, retinol. Claims 1-6, 8, and 10-18 have been included for examination.
Claims 7, 9, 19, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/2/26.
Claims 1-6, 8, and 10-18 were examined with regards to the retinoid species, acitretin and retinol, and are rejected.
Objection to Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code; see p. 15 of specification. 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 10-13, 15, and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isanta-Otal et. al., Indian J. Ophthalmol., vol. 67, pp. 1765-1768, publ. 2019, cited in an IDS, as evidenced by PubChem, “Retinol”, publ. 9/16/2004.
Isanta-Otal discloses a human female patient experiencing manifestations of ocular congenital erythropoietic porphyria (CEP) who was administered various medications, including a topical retinoid, vitamin A, also known in the art as retinol (p. 1765, abstract; pp. 1765-1766, bridging para; p. 1766, right col., last full para). Isanta-Otal discloses that after four months of treatment, the patient experienced less eye discomfort (p. 1766, right col., last full para). Retinol has the following chemical structure, as evidenced by PubChem (p. 3):
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. Retinol is included within formula (I) of claim 2, having ring A=cyclohexen-1-yl; R1=C9 alkenyl substituted with hydroxyl; included within formula (Ia) of claim 3, wherein R2=hydroxymethyl; within formula (Ib) wherein R2=hydroxymethyl; within formula (Ic) wherein R2=hydroxymethyl; within formula (Id) wherein R2=hydroxymethyl. Isanta-Otal anticipates the claims for the reasons above.
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.
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.
Claim(s) 8, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isanta-Otal et. al., Indian J. Ophthalmol., vol. 67, pp. 1765-1768, publ. 2019, cited in an IDS, as evidenced by PubChem, “Retinol”, publ. 9/16/2004, as applied to claims 1-6, 10-13, 15, and 17-18 in view of Sarkar, Indian J. Derm., Ven., Lep., vol. 79(6), pp. 759-771, publ. 2013.
The teachings of Isanta-Otal as evidenced by PubChem as discussed previously are incorporated herein. However, Isanta-Otal doesn’t explicitly teach or suggest treatment of CEP with the elected retinoid, acitretin.
Sarkar teaches retinoids effect cellular division and differentiation of stratified structures within the epidermis, with synthetic retinoids categorized within first generation (including retinol), second generation (including etretinate and acitretin), and third generation (including tazarotene, bexarotene, and adapalene) (p. 759, 1st 2 para of Intro). Sarkar teaches second generation retinoids such as acitretin were developed because they appeared to have improved efficacy in treating keratinizing disorders; additionally, acitretin has favorable pharmacokinetics (p. 759, 3rd para). Sarkar teaches acitretin to normalize epidermal cell differentiation, proliferation, and cornification (p. 760, left col., 1st para under Mechanism of action). Additionally, acitretin is available in topical preparations for treating keratinizing disorders (p. 765, right col., last para-p. 766, left col, top 2 lines). Acitretin has the structural formula shown:
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It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have treated CEP in an animal comprising administering the elected retinoid, acitretin, in consideration of the combined teachings of Isanta-Otal and Sarkar. As discussed previously, Isanta-Otal disclosed treatment of ocular symptoms of CEP in a female human patient comprising administering the topical retinoid, vitamin A, also known as retinol, and that this treatment helped decrease symptoms. Sarkar teaches acitretin as a second-generation retinoid used for treating skin disorders, having favorable pharmacokinetics and efficacy. Sarkar also teaches acitretin in topical formulations. One of ordinary skill in the art would have been motivated to have treated CEP in a human patient comprising administering a topical formulation comprising the retinoid, acitretin, as Isanta-Otal discloses topical administration of a retinoid, retinol, for treating symptoms of CEP, while Sarkar teaches acitretin to have favorable efficacy and pharmacokinetics in treating skin disorders. One of ordinary skill in the art would have arrived at the claimed method of treatment and have had a reasonable expectation that treatment of CEP by administering acitretin would be efficacious.
Information Disclosure Statement
The IDS filed on 6/17/24 has been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627