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 .
Status of Claims
Claims 106-125 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 10/17/24; 10/2/24; 3/11/25; 7/8/25; 10/13/25; 11/3/25; 1/7/26 and 2/18/26. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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 106- 125 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,016,843 Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· Both sets of claims refer to treating treating ALS comprising administering .
R)-2-amino-N-((S)- 1-(((S)-5 -amino-i1-(3- benzyl- 1,2,4-oxadiazol-5 -yl)pentyl)amino)-3 -(4-hydroxy-2, 6-dimethylphenyl)- 1- oxopropan-2-yl)-5 -guani dinopentanamide and edaravone or riluzole (see instant claims 106, 116 and patented claims 1, 13)
Both applications recite using the same compositions and/or derivatives thereof.
In view of the foregoing, the instant claims and the current application claims are obvious variations.
Claims 106- 125 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11273149 in view of Zheng et al. (WO 2019/118878) and Benata et al. (US 2021/0172963). Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· Both sets of claims refer to treating treating ALS administering R)-2-amino-N-((S)- 1-(((S)-5 -amino-i1-(3- benzyl- 1,2,4-oxadiazol-5 -yl)pentyl)amino)-3 -(4-hydroxy-2, 6-dimethylphenyl)- 1- oxopropan-2-yl)-5 -guani dinopentanamide
However the patented claims fail to teach administration includes edaravone or riluzole
Nonetheless when the patented specification is used as a dictionary, it teaches that co administration of edaravone or riluzole (see col. 2, lines 79+). Therefore it would have been obvious to one of ordinary skill in the art to treat ALS by co administration of edaravone or riluzole to the patient in need thereof with a reasonable expectation of success.
· Both applications recite using the same compositions and/or derivatives thereof.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 3/4/26
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