DETAILED ACTION
Claims 1-11, submitted on July 15, 2025, are pending in the application and are rejected for the reasons set forth below. No claim is allowed, although the application would be allowable if a terminal disclaimer were to be submitted, as discussed below.
This communication includes at least one new basis for rejection that was not necessitated by applicant’s amendment of the claims, nor based on information submitted in an information disclosure statement, so this Office action is non-final. See MPEP 706.07(a) (final rejection).
Withdrawn Rejections
The rejection of claims 1 and 5-11 under 35 U.S.C. 103 as being unpatentable over Ha (Invest. Ophthalmol. Vis. Sci. 2011;52(10):7749-60) in view of Sahlholm (Psychopharma-cology 2015;232(18):3443-53) is withdrawn because the examiner is persuaded that Ha found “no role of σR1 in mediating IOP” and that “S1R is not controlling IOP.” See appli-cant’s Remarks, submitted July 15, 2025, at pp. 5-6.
The rejection of claims 1-11 under 35 U.S.C. 103 as being unpatentable over Ha, Sahlholm, and Hosoya (Eur. J. Pharm. Biopharm. 2005;60(2):227-40) is likewise withdrawn.
The rejection of claims 1-11 for double patenting over Patent No. 11,738,012 B2 is withdrawn in view of the terminal disclaimer submitted on July 15, 2025.
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 possi-ble harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined appli-cation 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 Good-man, 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 applica-tions subject to examination under the first-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-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 accompa-nied 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(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 that 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/terminaldisclaimer.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 17/498,075. Although the claims at issue are not identical, they are not patentably distinct from each other. See the claims submitted on April 22, 2025, which are drawn to a method of treating a neuro-degenerative disease (claim 1) comprising administering pridopidine (claims 11-17). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not, in fact, been patented. The examiner suggests a terminal disclaimer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is 571-270-5993. The examiner can normally be reached Monday through Thursday, 7:00 am - 6:00 pm (Eastern Time). The examiner is generally not available on Fridays. Examiner interviews are available via telephone and video conferencing using an Office-supplied web-based collab-oration tool. To schedule an interview, applicant is encouraged to use the USPTO Auto-mated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Theodore R. Howell/ Primary Examiner, Art Unit 1628
October 8, 2025