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 .
Current Status
This action is responsive to the amended claims of 03/25/2026. Claims 1-31, 33-49, 62-66, 68-77, 79, and 116-117 are pending. Claims 32, 50-61, 67, 78, and 80-115 are canceled. Claims 3-14, 17, 25-31, 38-40, 45-47, 64-66, 69, 71, and 74-77 are withdrawn. Claims 116-117 are new.
Claims 1-2, 15-16, 18-24, 33-37, 41-44, 48-49, 62-63, 68, 70, 72-73, 79, and 116-117 have been examined on the merits.
Election/Restrictions
The amendments of 03/25/2026 have overcome the previous prior art rejection. Thus, the Markush search has been extended to cover wherein E-G is –(C=O)NRx- wherein Rx and Z4 (or Z1) together form an optionally substituted 6-membered heterocycle. The search retrieved prior art for the following two species:
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and
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.
Since the search retrieved art, per Markush search practice, the search will not be unnecessarily extended to further species in this action.
These species read on claims 1-2, 15-16, 18-24, 33-37, 41-44, 48-49, 62-63, 68, 70, and 72-73.
A search for the species of claims 79 and 116-117 did not retrieve any art. Thus, these claims are also examined here.
Claims 3-14, 17, 25-31, 38-40, 45-47, 64-66, 69, 71, and 74-77 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/25/2025.
Priority
The effective filing date remains 05/07/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/05/2025, 03/25/2026, and 05/01/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Examiner acknowledges receipt of and has review the claim amendments and remarks of 03/25/2026; no new matter is found.
The objections to claims 1-2, 15, 18, 20-21, 23-24, 33-37, 41-44, 48-49, 62, and 67-69 are each withdrawn since Applicant has amended in line with Examiner’s suggestions.
The 112(b) and 112(d) rejections of claims 20-21 are withdrawn since Applicant replaced "(C1-C6) alkynyl" with "(C2-C6) alkynyl".
The 102(a)(1) rejection of claims 1-2, 15, 18, 20-21, 23-24, 33-37, 41-44, 48-49, 62, and 67-69 as being anticipated by ACS (American Chemical Society (ACS), Chemical Abstracts Service, Registry Number 1903911-22-7, entered in STN on 05 May 2016) is withdrawn. Applicant has narrowed the scope of Formula Ia to exclude wherein V is absent, as taught by ACS.
The non-statutory double patenting rejections over co-pending Application No. 17/923,837, 18/707,109, and 18/707,125 are maintained, below. Applicant has asked that these rejections be held in abeyance until allowable subject matter is identified. The rejections are maintained and modified to account for the Markush search extension, necessitated by Applicant’s amendments.
Response to Amendment
Claim Rejections - 35 USC § 102 – necessitated by amendment
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 15, 18, 20-24, 33-37, 41-44, 48-49, 62-63, 68, and 70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AURORA (Aurora Fine Chemicals, American Chemical Society Chemical Abstracts Service, Registry Number 1705927-91-8, entered in STN on 17 May 2015).
AURORA teaches:
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.
Regarding claim 1, the AURORA compound reads on Formula Ia as follows:
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ring A is
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, X4 is N, X2-X3 and X8-X9 are CR1 wherein R1 is H, Q is O, Y1-Y4 are CR2 wherein R2 is H, -E-G- is –(C=O)NRx– wherein Rx and Z4 (or Z1) together form a 6-membered heterocycle, Z1-Z4 are CR3 wherein R3 is H where valence permits (i.e., R3 is absent on Z4), V is O, and R4 is C1alkyl (-CH3).
Regarding claims 2 and 18, Q is O.
Regarding claim 15, A is
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, X4 is N, X2-X3 and X8-X9 are CR1 wherein R1 is H.
Regarding claims 20-24, R1 is H.
Regarding claims 33-36 and 62,
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is
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wherein each R2 is H:
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.
Regarding claim 37, -E-G- is –(C=O)NRx– wherein Rx and Z4 together form a 6-membered heterocycle.
Regarding claims 41-44,
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is
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wherein R3 is H where valence permits (i.e., R3 is absent on Z4):
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.
Regarding claims 48-49,
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is
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wherein m is 2, J is C(Rz)2, and Rz is H:
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wherein Z1-Z3 are CH.
Regarding claims 63, 68, and 70, V-R4 is O-R4 and R4 is C1alkyl (-CH3).
Claims 1-2, 15-16, 19-24, 33-37, 41-44, 48-49, 62-63, 68, 70, and 72-73 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ENAMINE (Enamine, American Chemical Society Chemical Abstracts Service, Registry Number 1241176-88-4, entered in STN on 15 Sep 2010).
ENAMINE teaches
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.
Regarding claim 1, the ENAMINE compound reads on Formula Ia as follows:
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ring A is
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, X4 and X9 are N, X2-X3 and X8 are CR1 wherein R1 is H, Q is NRa wherein Ra is H, Y1-Y4 are CR2 wherein R2 is H, -E-G- is –(C=O)NRx– wherein Rx and Z4 (or Z1) together form a 6-membered heterocycle, Z1-Z4 are CR3 wherein R3 is H where valence permits (i.e., R3 is absent on Z4), V is O, and R4 is C1alkyl (-CH3).
Regarding claims 2 and 19, Q is NRa wherein Ra is H: Q is NH.
Regarding claims 15-16, A is
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, X4 and X9 are N, X2-X3 and X8 are CR1 wherein R1 is H:
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.
Regarding claims 20-24, R1 is H.
Regarding claims 33-36 and 62,
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is
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wherein each R2 is H:
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.
Regarding claim 37, -E-G- is –(C=O)NRx– wherein Rx and Z4 together form a 6-membered heterocycle. The compound can also be interpreted wherein Z1 is the attachment point of Rx rather than Z4.
Regarding claims 41-44,
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is
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wherein R3 is H where valence permits (i.e., R3 is absent on Z4):
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. The compound can also be interpreted wherein Z1 is the attachment point of Rx rather than Z4.
Regarding claims 48-49,
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is
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wherein m is 2, J is C(Rz)2, and Rz is H:
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wherein Z1-Z3 are CH.
Regarding claims 63, 68, and 70, V-R4 is O-R4 and R4 is C1alkyl (-CH3).
Regarding claims 72-73, Ra is H.
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, 15-16, 19-24, 33-37, 41-44, 48-49, 62, 68, 70, and 72-73 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1, 79, 83, and 117-119 of copending Application No. 17/923,837 (reference application – amended claims of 03/25/2026). Although the claims at issue are not identical, they are not patentably distinct from each other.
App. No. ‘837 claims 79 and 83 are drawn to a series of species of compounds which are species of instant Formula Ia. The overlapping species of claim 79 are:
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on Pg. 33; the nine compounds on Pg. 34; and
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,
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, and
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on Pg. 35 (a duplicate of the last compound also appears on Pg. 36). The annotations on the final compound apply to all cited compounds, above. The recited species read on Formula Ia wherein: ring A is either pyridine or phenyl wherein R1 is H, Me, or F; Q is NH or O; Y1-Y4 are CR2 wherein R2 is H where valence permits; -E-G- is -(C=O)NRx- wherein Rx and Z4, Z1, Y3, or Y4 together form a 5-6-membered heterocycle; Z1-Z4 are CR3 wherein R3 is H where valence permits, V is NH, and R4 is heteroaryl substituted with one or more R5 that is H, halogen, Me, or CN. The first 12 species of claim 83, the 1 species of claim 117, the 1 species of claim 118, and the 1 species of claim 119 read similarly on Formula Ia.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 15-16, 19-24, 33-37, 41-44, 48-49, 62, 68, 70, 72-73, 79, and 116-117 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1, 99, and 103-104 of copending Application No. 18/707,109 (reference application – claims of 05/02/2024). Although the claims at issue are not identical, they are not patentably distinct from each other.
App. No. ‘109 claims 99 and 103-104 are drawn to a series of species of compounds which are species of instant Formula Ia. The overlapping species of claim 99 are:
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Pg. 54;
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Pg. 61;
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,
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,
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,
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Pg. 64;
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and
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Pg. 65; and all compounds of Pg. 66-67. The overlapping species of claim 103 are:
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and
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. The overlapping species of claim 104 are 23-38 and 44-45, which Examiner understands to overlap with the compound structures recited above. The recited species read on Formula Ia wherein: ring A is either pyridine or
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wherein R1 is H, Me, halogen, CN, or heterocycle; Q is NH; Y1-Y4 are CR2 wherein R2 is H, Me, or halogen where valence permits; -E-G- is -(C=O)NRx- or -NRx(C=O)- wherein Rx and Z4, Z1, Y3, or Y4 together form an optionally substituted 5-6-membered heterocycle, -SO2NH-, -NH2SO2-, or
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wherein W1-W5 are each chosen from N or CH or C; Z1-Z4 are CR3 wherein R3 is H, Me, or halogen where valence permits, V is NH, and R4 is heteroaryl substituted with one or more R5 that is H or Me. At least the first, fifth, and sixth species recited here read on the species in instant claims 79 and 116-117.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 15-16, 19-24, 33-36, 41-44, 48-49, 62, 68, 70, and 72-73 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1 and 132-135 of copending Application No. 18/707,125 (reference application – claims of 05/02/2024). Although the claims at issue are not identical, they are not patentably distinct from each other.
App. No. ‘125 claims 132-135 are drawn to a series of species of compounds which are species of instant Formula Ia. The overlapping species of claim 132 are:
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. The overlapping species of claim 133 is:
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Pg. 117. The overlapping species of claim 134 are:
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and
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. The compounds above are also recited in claim 135. The recited species read on Formula Ia wherein: ring A is pyridine wherein R1 is H or Me; Q is NH; Y1-Y4 are CR2 wherein R2 is H where valence permits; -E-G- is -NRx(C=O)- wherein Rx and Z4 or Z1 together form a 5-membered heterocycle; Z1-Z4 are CR3 wherein R3 is H or Me where valence permits, V is NH, and R4 is heteroaryl substituted with one or more R5 that is H or Me.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Note: the above double patenting rejections read on some withdrawn claims. The double patenting rejections may be adjusted to include currently withdrawn claims in a future action wherein the Markush search of Formula Ia is extended.
Conclusion
Claims 1-2, 15-16, 18-24, 33-37, 41-44, 48-49, 62-63, 68, 70, 72-73, 79, and 116-117 are rejected.
The close art for claims 79 and 116-117 may be considered the two references applied above: AURORA (Aurora Fine Chemicals, American Chemical Society Chemical Abstracts Service, Registry Number 1705927-91-8, entered in STN on 17 May 2015) or ENAMINE (Enamine, American Chemical Society Chemical Abstracts Service, Registry Number 1241176-88-4, entered in STN on 15 Sep 2010). Both teach compounds with at least two structural differences, e.g., number of ring members in G-Z4, Q and V are O not NH, substituents on A and R4. Alternatively, ACS (American Chemical Society (ACS), Chemical Abstracts Service, Registry Number 1903911-22-7, entered in STN on 05 May 2016) provided with the action of 09/29/2025 is close art which teaches a compound with at least two structural differences: e.g., V is absent, Q is O, substituents on A and R4. All art returned by the search for these species is published after the instant effective filing date and none of the references are by another (see SEARCH 6 of the attached search notes).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights