DETAILED ACTION
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 .
Priority
This application, filed 7 October, 2022, is a national stage application of PCT/US2021/026481, filed 8 April, 2021, which claims the benefit of U.S. Provisional Application 63/126,494, filed 16 December, 2020, U.S. Provisional Application 63/072,922, filed 31 August, 2020, U.S. Provisional Application 63/044,318, filed 25 June, 2020, and U.S. Provisional Application 63/007,331, filed 8 April, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6 July, 2026 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 6 July, 2026, in the matter of Application N° 17/917,729. Said documents have been entered on the record.
Claims 1 and 20 are amended. No new matter has been introduced.
Claims 23-24, 26, 28, 30, 32, 34, 43-48, 50, 52, 55-56, 58, 67-70, 77-78, 80-83, and 86-89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 August, 2025.
Thus, Claims 1-2, 6, 8, 12, 14, 20, 22, 71-72, and 75 represent all claims currently under consideration.
Response to Arguments
Applicant’s arguments have been considered but are not persuasive.
Regarding the nonstatutory double patenting (NSDP) rejection for copending application ‘734, Applicant argues that the claimed compounds are patentably distinct because the A and B substituents are attached at different positions of the bicyclic core and because the atom opposite the amide carbonyl differs between the respective scaffolds. These distinctions, however, constitute the positional and heteroatom variations addressed by the rejection. Applicant has not provided evidence establishing that these structural variations impart an unexpected property or otherwise render the presently claimed compounds patentably distinct from the closely related compounds claimed in the ‘734 application. Applicant’s assertion that the altered configuration “should have a considerable impact” (Remarks, Pg 24, Para 2) on target binding is not accompanied by comparative evidence demonstrating such an effect. Accordingly, the provisional nonstatutory double patenting rejection is maintained.
Regarding the NSDP rejection for copending application ‘632, Applicant argues that it cannot serve as a reference for the provisional NSDP rejection because the instant application has an earlier filing date.
Examiner acknowledges the relative filing dates of the copending applications. However, pursuant to MPEP §804(I)(B)(1)(b)(i), withdrawal of a provisional NSDP rejection based on the relative patent term filing dates of copending applications is appropriate where the provisional NSDP rejection is the only rejection remaining in the application having the earlier patent term filing date. Such is not the case here, as other grounds of rejection remain outstanding.
Moreover, the claimed subject matter of the instant application and the ‘632 application is not patentably distinct. Claim 1 of the ‘632 application encompasses subject matter overlapping the presently claimed. In particular, at least one species (e.g., instant Compound 186) encompassed by instant Claim 22, which was previously indicated as allowable if rewritten in independent form, is also encompassed by the subject matter of at least Claim 1 of the ‘632 application.
Accordingly, the previous indication of allowable subject matter in Claim 22 is withdrawn, and claim 22 is included in the provisional NSDP rejection set forth below.
Double Patenting (MAINTAINED)
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, 6, 8, 12, 14, 20, 71-72 and 75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-2, 4, 6, 8, 10, 18-23, 25, 27, 29, 31, 39-43 and 46 of copending Application No. 17/917,734 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the only differences reside in the position of substituents (i.e., positional isomers) and/or the placement of heteroatoms within the core claimed structure. Such variations represent obvious modifications that do not render the claimed compounds patentably distinct.
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.). See MPEP §2144.09(II).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 6, 8, 12, 14, 20, 22, 71-72 and 75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 3, 5, 18, 26, 35, 78, 84, 113, 123, 145, 160, 172, 216, 228, 240-241, 243-244, 268, 281, 298, 300, 324, 332, 334-335, 337, 339, 364, 371, 374, 407, 413, 415-416, and 431-432 of copending Application No. 17/700,632 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘632 recites a genus encompassing compounds having the same core structural arrangements and corresponding substituent selections as compounds presently claimed. Indeed, instant Compound 186 recited in instant Claim 22 is fully encompassed within the scope of ‘632’s Claim 1 Formula I, wherein L1 and L2 are each absent, A is heteroaryl, optionally substituted with two instances of R1 wherein each are a C1-alkyl, B is heterocyclyl, Y = N, n is 0, and m is 0. Thus, with respect to such commonly encompassed subject matter, the claims are overlapping and do not define patentably distinct inventions.
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‘632 – Formula I
Instant Formula V-a
Instant Compound 186
To the extent that the remaining instant claims differ from the subject matter encompassed by the claims of the ‘632 application, the differences reside in the selection and/or placement of substituents within closely related chemical scaffolds. Such differences represent obvious variations of the invention claimed in the ‘632 application. One of ordinary skill in the art, seeking additional compounds within the claimed class, would have found it obvious to vary the identity and/or position of substituents within the claimed scaffold to obtain structurally related analogs, absent evidence that the particular variations produce an unexpected property or otherwise establish patentable distinctness.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
