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 .
Response to Amendment and Argument
The response filed on 9/16/26 has been entered.
Applicants’ arguments filed 9/16/26 have been fully considered but they are not deemed to be persuasive.
Claims 106-125 are pending in this office action.
Receipt is acknowledged of the Information Disclosure Statement filed 4/10/. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Maintained 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 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.
Applicant argues that “(i) the recited peptidomimetic; and (ii) a second therapeutic agent - riluzole or edaravone, respectively. These claims are directed at combination therapy methods in which the second agent is a required element.
In response, Applicant’s argument is found unpersuasive because patented claim I recite the term “comprising” which does not exclude other actives to be present. Additionally, claim 14 of the patent does recite that the wherein the therapeutic agent is selected from the group consisting of: riluzole (Rilutek®), edaravone (Radicava®) Therefore one of ordinary skill in the art would have used the patent to practice the instant claimed invention with a reasonable expectation of success.
Applicant’s argument is found unpersuasive, and the rejection is maintained.
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 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.
Applicant argues that “The combination therapy claims of the '149 Patent (claims 116-118) recite combination with levodopa or SSRI antidepressants - not riluzole or edaravone. The Examiner does not adequately explain what Zheng and Benata teach, how they would modify the '149 Patent claims, or why one of ordinary skill in the art would have been motivated to combine them with a reasonable expectation of success”Although the patented claims fail to recite . Applicant respectfully submits that the Examiner has not established a prima facie case of obviousness-type double patenting over the '149 Patent claims”
In response, Although the patented claims fail to recite co administration of co administration of edaravone or riluzole, as evidenced by Jo et al. TDP-43 plays a role in neurogenerative diseases (see tittle) and that TAR DNA-binding protein 43 (TDP-43) aggregates are frequently observed in multiple diseases, such ALS, FTD, AD, therefore it would have been obvious to one of ordinary skill in the art would have co-administered a levodopa and a 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 by substituting levodopa with riluzole to the treat ALS with a reasonable expectation of success because as evidenced by Jo et al. supra.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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 10/13/26
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