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 the Application
Claims 1-2, 12-16, and 29-35 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 03/02/2026 are acknowledged. Claims under consideration in the instant office action are claims 1-2, 12-16, and 29-35.
Applicants' arguments, filed 03/02/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 1-2, 12-16, and 29-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,793,563 in view of Patani (Bioisosterism: A Rational Approach in Drug Design, Chem. Rev. 1996, 96, pp. 3147-3176).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite similar compounds of formula I. U.S. Patent No. 10,793,563 recite a compound of formula XV-a, XV-b, and XV-c.
U.S. Patent No. 10,793,563 does not recite compounds of formula I as recited wherein Ring B comprises an additional nitrogen in the bicyclic ring.
Patani is drawn towards the bioisosterism of pharmaceutically active compounds (Introduction, pg. 3147). Patani teaches -CH2- and -NH- as ring equivalent bioisosters (see Tables 24-25, 27).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to formulate a compound of formula I since bioisosteric replacement of -CH2- for -NH- would retain its activity as GCN2 inhibitors as taught by Patani, with a reasonable expectation of success absent evidence of criticality of the particular steps.
Claims 1-2, 12-16, and 29-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,084,438 in view of Patani (Bioisosterism: A Rational Approach in Drug Design, Chem. Rev. 1996, 96, pp. 3147-3176).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite similar compounds of formula I. U.S. Patent No. 12,084,438 recite a compound of formula I.
U.S. Patent No. 12,084,438 does not recite compounds of formula I as recited wherein Ring B comprises an additional nitrogen in the bicyclic ring.
Patani is drawn towards the bioisosterism of pharmaceutically active compounds (Introduction, pg. 3147). Patani teaches -CH2- and -NH- as ring equivalent bioisosters (see Tables 24-25, 27).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to formulate a compound of formula I since bioisosteric replacement of -CH2- for -NH- would retain its activity as GCN2 inhibitors as taught by Patani, with a reasonable expectation of success absent evidence of criticality of the particular steps.
Response to Arguments
Applicant argues that “The Office does not identify any motivation that would have prompted a person of ordinary skill to replace any specific -CH- moiety in the compounds of the reference patents with an -N- moiety, let alone a motivation to make the specific replacement necessary to arrive at the claimed compounds. The claims of the reference patents certainly provide no such motivation.” The Examiner respectfully disagrees since although Tables 24-25 and 27 of Patani exemplify substitution of sp3 hybridized atoms and not sp2 hybridized atoms, Table 29 does disclose the replacement of sp2 hybridized -CH- with sp2 hybridized -N-. Patani teaches that the trivalent substitution of CH and N are the most commonly used substitution in modern drug design (pg. 3159, right column, 3rd paragraph), and one of ordinary skill in the art would have thus been motivated to try to employ such a substitution as it is commonly practiced in drug design. Patani teaches that bioisosteric replacements, including between -CH2- and -NH-, can provide improvements in safety and efficacy (pg. 3147, right column, first paragraph; see Tables 24-25, 27). One of ordinary skill in the art would have thus been motivated to substitute -CH2- for -NH- to arrive at a compound of formula I, with a reasonable expectation of success absent evidence of criticality of the particular formulation.
Applicant also argues that “Nothing in Table 29 of Patani would have prompted a person of ordinary skill to replace any specific -CH- moiety in the compounds of the reference patents with an -N- moiety, let alone to make the specific replacement necessary to arrive at the claimed compounds. The bicyclic ring structure of Compound 56 is structurally different than the bi cyclic ring structure of the B ring of the claims of the reference patents. For example, the bi cyclic ring structure of Compound 56 comprises two fused 6-membered rings. In contrast, the bi cyclic ring structure of the B ring of the claims of the reference patents comprises a 6-membered ring fused to a 5-membered ring. Furthermore, Compound 56a comprises one nitrogen in the bi cyclic ring, whereas the bi cyclic ring structure of the B ring of the claims of the reference patents comprises two nitrogens in the bi cyclic ring. As such Patani provides no suggestion or rationale to modify the claims of the reference patents at the specific carbon in the 6-membered ring of the 5,6-fused bi cyclic ring to arrive at the compounds of the pending claims in the present application.” The Examiner respectfully disagrees since although Patani does not disclose the specific bicyclic ring recited, Patani teaches particular bioisostere replacements, such as -Ch2- and -NH- as ring equivalent bioisosters (see Tables 24-25, 27, 29), including in bicyclic ring systems.
Conclusion
Claims 1-2, 12-16, and 29-35 are rejected.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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