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 .
Election/Restrictions
Applicant’s election of the method of treating atrophic age-related macular degeneration with a tamibarotene or tamibarotene ethyl ester in the reply filed on 3 April 2026 is acknowledged.
In view of the results from the Examiner’s search, this requirement is WITHDRAWN.
Status of the Claims
Claims 1-7 are pending, presented for examination, and rejected as set forth below.
Priority
The instant application is a Divisional of application 16/628,232 filed 2 January 2020, which is a National Stage entry of International application PCT/JP2018/025122 filed 3 July 2018.
Receipt is acknowledged of certified copies of papers in parent application 16/628,232 required by 37 CFR 1.55 relating to Japanese national application 2017-131087 filed 4 July 2017.
The Examiner notes that while the instant application is a Divisional of the ‘232 application, filed subsequent to a Restriction requirement made by the Examiner on 1 June 2022, the present application incorporates claims not consonant in scope with the requirement made in the parent case. Specifically, each of Claims 2 and 3 include embodiments where the retinitis pigmentosa elected by Applicants in the ‘232 application are present as a species of disease the symptoms of which are improved by induction of rod-cell regeneration. This overlap fails to maintain the consonance required for the safe harbor provisions of 35 U.S.C. 121 to apply.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Whitcup (WO2005/056010)(of record in ‘232 application) in view of Muratake (U.S. PGPub. 2014/0121407).
Whitcup describes treating retinitis pigmentosa by administering a therapeutically effective amount of the retinoic acid receptor agonist tazarotene by the topical application of such a retinoid to the eye by an eye drop. (Pg.5, L.8-18). Whitcup indicates that additional diseases, including each of the Stargardt’s and Best’s diseases of claims 2 and 5, as well as non-exudative age-related macular degeneration, which is synonymous with the atrophic age-related macular degeneration elected by applicants. (Pg.2, L.8-9; Pg.3, L.8-11).
Whitcup does not, however, describe the tamibarotene of Claims 4 and 5 as a retinoic acid receptor agonist suitable for ophthalmic administration.
Muratake indicates that tamibarotene (recited as “4-[(5,6,7,8-tetrahydro-5,5,8,8- tetramethyl-2-napthalenyl)carbamoyl]benzoic acid (Am80)”) is a retinoic acid receptor agonist, [0007], suitable for use in the treatment of eye diseases including age-related macular degeneration, [0030], by topical application via eye drops. [0031].
It would have been prima facie obvious to one having ordinary skill in the art to have substituted the tamibarotene of Muratake for the tazarotene Whitcup describes as used to treat retinitis pigmentosa, Stargardt’s and Best’s diseases, and non-exudative age-related macular degeneration by the topical application of a retinoic acid receptor agonist eye drop. This is because Whitcup describes using retinoid compounds in the treatment of RAR-related diseases, and Muratake indicates that tamibarotene was known at the time of the instant application as a retinoic acid receptor agonist known to be useful in the treatment of ocular diseases including age-related macular degeneration by topically applying the drug in the form of an eye drop. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,931,327. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘327 patent describe methods falling within the breadth of instant claims 2 and 3, anticipating them thereby.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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