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 .
Receipt of claim amendments and arguments filed on 10/15/2025 is acknowledged. Claims 162-183 are currently pending.
Terminal Disclaimer
The terminal disclaimer filed on 10/15/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 11,285,158 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Allowable subject matter
Claims 177-183 are allowable.
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 162-176 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 10,954,242. The claims have been amended to recite “a subject in need thereof” and “a pharmaceutical composition comprising”. Although the claims at issue are not identical, they are not patentably distinct from each other because the method comprising administering topically to the skin of a subject in need of increasing skin pigmentation (cl. 162) and to the skin of a subject in need of increasing the appearance of skin pigmentation (cl. 170), an effective amount of the composition of the instant claims was covered by, and would have been obvious over, claim 16 of the patent. Note that claim 16 of the patent claims a method of treating albinism comprising administering a compound of claim 1.
The patent teaches exemplary compounds of formula: YKL-05-70 (at col. 5), YKL-04-136-6 (col. 8), YKL-06-60 (col. 17), YKL-06-61 (col. 17), YKL-06-62 (col. 17) and YKL-06-29 (col. 20), as a representation of what is claimed at claims 1 and 16. Particularly, compounds YKL-06-60 (cl. 13), YKL-06-61 (claim 11) and YKL-06-62 (claim 12), are claimed embodiments of the compounds of the patent. The patent teaches pharmaceutical compositions comprising the compound of patented claim 1 and a pharmaceutically acceptable excipient (see patented claim 14).These are particular embodiments of the invention claimed in the patent which also show the preferred compounds of the claims.
Finding of prima facie obviousness--rational and motivation
What is covered by the reference claims was exemplified in the patent as discussed above. It would have been prima facie obvious to practice the method of treating albinism of patented claim 16 with the pharmaceutical compositions comprising the compound of patented claim 1 and a pharmaceutically acceptable excipient, as in patented claim 14, and to select the compound examples YKL-05-70 (at col. 5), YKL-04-136-6 (col. 8), YKL-06-60 (col. 17), YKL-06-61 (col. 17), YKL-06-62 (col. 17) and YKL-06-29 (col. 20), from the disclosure of the invention claimed in the patent or from the claims in the patent since these are the embodiments that provide support to and fall within the scope of the compounds of claim 1 of the patent.
This rejection is proper under MPEP 804 II. B. 2. (a):
Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because ONLY "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
The treatment of albinism focuses on protecting the skin and eyes from sun exposure thus, it is treated topically, and the patent taught topical administration of the compounds and pharmaceutical compositions comprising the compounds with pharmaceutically acceptable excipients.
Conclusion
Claims 162-176 are rejected. Claims 177-183 are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621