DETAILED ACTION
This office action is in response to applicant’s filing dated November 14, 2025.
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 1, 2, 9, 10, 15, 19, 24, 35-37, 42, 49, 70-73, 82-84 and 86-95
are pending in the instant application. Acknowledgment is made of Applicant’s amendments filed November 14, 2025.
Election/Restrictions
Applicant’s election without traverse of invention of Group I, claims 1, 2, 9, 10, 15, 19, 24, 35-37, 42, 49, 70-73 and 86-95, drawn to compounds of Formula (I) or compositions thereof, in the reply filed on November 14, 2025 is acknowledged.
Claims 82 – 84 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 14, 2025.
Applicant’s election without traverse of compound 19:
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as a single species, in the reply filed on November 14, 2025 is acknowledged. Upon performing the search of prior art Examiner detected compounds related to non-elected species. Hence, the examination will expand to include non-elected species, compounds of Formula (I) where R2 is
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, such as
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.
Claims 10, 15, 24, 36 and 87 – 92 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 November 14, 2025.
Claims 1, 2, 9, 19, 35, 37, 42, 49, 70-73, 86 and 93 - 95 are under consideration in the present office action as related to the elected species, compound 19 and expanded species where variable R2 in the compound of Formula (I) is
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.
Priority
The present application was filed on April 18, 2023 and claims the benefits of priority of U.S Provisional Application No. 63/484,135, filed February 9, 2023 and U.S. Provisional Application No. 63/363,296, filed April 20, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/10/2023, 07/17/2023 and 11/14/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 37 and 42 are objected to because of the following informalities: as being incorrectly dependent on subsequent claims. The incorrect dependencies as shown herein:
Claim 37 is dependent on subsequent claim 42;
Clam 42 is dependent on subsequent claim 49.
Appropriate correction is required. In the instant office action claims 37 and 42 will be examined as dependent upon claim 35.
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, 9, 19, 35, 37, 42, 49, 70-73, 86 and 93 - 95 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 5, 12 – 17 and 21 of U.S. Patent No. US 11,952,374.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims are directed to a compound of Formula (I):
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, where R1 is
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; R2 is
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or
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, where Y1D, Y2D, Y3D, Y1B, Y2B, Y3B and Y4B is CH or N; RA2 is CH3, RA4 is C1-5 alkyl, RA5 is hydrogen, halogen or C1-5 alkyl. The exemplary compounds of instant invention are:
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(compound 19, claim 71),
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(claim 71). Instant claims are further directed to a pharmaceutical composition comprising an effective amount of a compound of Formula (I), or a pharmaceutically acceptable salt thereof, and excipient.
Claims of U.S. Patent No. US 11,952,374 are directed to a compound of Formula (I)
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(Examiner notes: the structure of compound of formula (I) drawn in claim 1 has an error, so the structure was taken from specification, column 10, lines 5 – 15). The variables of compound of Formula (I) have following structures:
Z1 is -C(=O)-, n is 1; R1 is
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; R2 and R3 are independently hydrogen or an unsubstituted C1-4 alkyl; R4, R5, R6 and R7 are each hydrogen; R8 is a 5- to 6-member monocyclic heteroaryl that includes 1 to 3 heteroatoms (O, S and N), and is optionally substituted with one or more unsubstituted C1-6 alkyl groups; R9 is a substituted phenyl, a fused-bicyclic heteroaryl substituted with unsubstituted C1-4 alkyl. Patented claims are further directed to a pharmaceutical composition comprising an effective amount of a compound of Formula (I), or a pharmaceutically acceptable salt thereof, and excipient.
The exemplary patented compounds are:
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,
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. Although exemplary compounds do not show fragment
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as R9 variable, claim 1 teaches substituted fused bicyclic heteroaryl as R9 variable. Although patented exemplary compounds have fragment
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(ethyl pyrazole) as R8 variable, while instantly claimed compounds have
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(dimethyl pyrazole) in the equivalent position, patented claims 1 and 21 teach 5-membered heteroaryl with 1-3 heteroatoms (e.g. nitrogen), substituted with one or more C1-4 alkyl groups. Moreover, the compounds of the same structure where the only difference is two methyl groups or one ethyl group in pyrazolyl ring, have a very close structural similarity, in fact they are considered to be positional isomers. The compounds of close structural similarity are presumably possessing similar properties. MPEP 2144.09 states: 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).
Thus, taking into consideration all said above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to make various compounds of similar structure possessing similar properties, to arrive at claimed compounds. The one of ordinary skills would be motivated to do so in search of an active agent with improved desired properties with the reasonable expectation of success.
Conclusion
Claims 1, 2, 9, 19, 35, 37, 42, 49, 70-73, 86 and 93 – 95 are rejected.
Claims 37 and 42 are objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691