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 .
Status of the Claims and Response to Restriction Requirement
Claims 1-4, 10, 14-16, 19-20, 25, 31, 33, 43, 48, 52, 54, 63-67, 69, 73, 76 and 79-80 are pending as of the response filed on 12/16/2025. Claims 5-9, 11-13, 17-18, 21-24, 26-30, 32, 34-42, 44-47, 49-51, 53, 55-62, 68, 70-72, 74-75, 77-78 and 81-101 are cancelled. Applicant’s election of group I claims 1-4, 10, 14-16, 19-20, 25, 31, 33, 43, 48, 52, 54, 63-67 and 69 without traverse is acknowledged. Claims 73, 76 and 79-80 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election of the following species without traverse is acknowledged.
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Applicants submit that the elected species is encompassed by claims 1-4, 10, 14-16, 19, 25, 31, 33, and 64. However, the examiner notes that the elected species is encompassed by claims 1-4, 10, 14-16, 25, 31, 33, 64 and 69. Claims 19-20, 43, 48, 52, 54, 63, 65-67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Therefore, claims 1-4, 10, 14-16, 25, 31, 33, 64 and 69 have been examined to the extent to which they are readable on the above identified elected invention and elected species.
In view of the pending claims, the following prior art that anticipates the compounds of Formula I of Markush claim 1 and/or renders obvious the compounds of Markush claim 1 and the instantly elected species of compound are found, as discussed in the rejections below.
Priority
This application is a 371 of PCT/US2021/064516 filed 12/21/2021, which claims priority to PRO 63/129,223 filed 12/22/2020.
The subject matter of claims 1-4, 10, 14-16, 25, 31, 33, 64 and 69 are supported by the ‘223 provisional application and accordingly, have an effective filing date of 12/22/2020.
Information Disclosure Statement
The information disclosure statements submitted on 01/16/2024 and 01/25/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation
Claim 1 recites certain functional groups within the definition of Y are optionally substituted with one Z group and certain functional groups within the definition of Z are optionally substituted with 1-2 R8 groups. However, claims 31 and 33, do not require Z or R8 to actually be present in the compound, they simply define what Z or R8 must be if present in the compound.
Claim Rejections - 35 USC § 102
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 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.
Claim Interpretation: Instant claims 31 and 33 are drawn to limitations of Z or R8, which are optional substituents for a compound of Formula I as in instant claim 1. The dependent claims do not actually require the Z or R8 substituent to be present, they simply define the species of Z or R8 that must be present if the substituent is present in the compound. As such, a compound lacking the corresponding optional substituents still falls within the scope of the dependent claims.
Claims 1-3, 10, 14-16, 31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-2555523-22-1 (21/54), entered 10 December 2020, in the IDS.
Regarding instant claim 1, Database Registry compound, RN-2555523-22-1 teaches the following compound.
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The above compound falls within the scope of Formula I as in instant claim 1 wherein,
R1 is 5 membered monocyclic heterocyclyl (tetrahydro-3-furanyl);
R2 is -CN;
X1 is CR3, R3 is H;
X2 is CH;
X3 is CR3, R3 is H;
Y is phenyl;
which satisfies the proviso that wherein each 5-7 membered monocyclic heterocyclyl independently has 1-2 ring heteroatoms independently selected from N, O, and S.
Further, this satisfies the limitations of claims 2-3, 10, 14-16, 31 and 33.
Claims 1-3, 10, 14-16, 31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-2554452-43-4 (22/54), entered 10 December 2020, in the IDS.
Regarding instant claim 1, Database Registry compound, RN-2554452-43-4 teaches the following compound.
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The above compound falls within the scope of Formula I as in instant claim 1 wherein,
R1 is phenyl substituted with 1 Ra, Ra is NR11R11, each R11 is H (benzamine);
R2 is C1 alkyl (methyl);
X1 is CR3, R3 is H;
X2 is CH;
X3 is CR3, R3 is H;
Y is phenyl.
Further, this satisfies the limitations of claims 2-3, 10, 14-16, 31 and 33.
Claims 1-3, 10, 14-16, 31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-2550427-02-4 (23/54), entered 08 December 2020, in the IDS.
Regarding instant claim 1, Database Registry compound, RN-2550427-02-4 teaches the following compound.
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The above compound falls within the scope of Formula I as in instant claim 1 wherein,
R1 is 5 membered monocyclic heterocyclyl (2-pyrrolidinyl);
R2 is C1 alkyl (methyl);
X1 is CR3, R3 is H;
X2 is CH;
X3 is CR3, R3 is H;
Y is phenyl;
which satisfies the proviso that wherein each 5-7 membered monocyclic heterocyclyl independently has 1-2 ring heteroatoms independently selected from N, O, and S.
Further, this satisfies the limitations of claims 2-3, 10, 14-16, 31 and 33.
Claims 1-3, 10, 14-16, 31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-2548026-21-5 (24/54), entered 07 December 2020, in the IDS.
Regarding instant claim 1, Database Registry compound, RN-2548026-21-5 teaches the following compound.
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The above compound falls within the scope of Formula I as in instant claim 1 wherein,
R1 is 5 membered monocyclic heteroaryl (2-thiazolyl);
R2 is C1 alkyl (methyl);
X1 is CR3, R3 is H;
X2 is CH;
X3 is CR3, R3 is H;
Y is phenyl;
which satisfies the proviso that wherein each 5-6 membered monocyclic heteroaryl independently have 1-4 ring heteroatoms independently selected from N, O, and S.
Further, this satisfies the limitations of claims 2-3, 10, 14-16, 31 and 33.
Claims 1-4, 10, 14-16, 31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-2537501-59-8 (29/54), entered 30 November 2020, in the IDS.
Regarding instant claim 1, Database Registry compound, RN-2537501-59-8 teaches the following compound.
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The above compound falls within the scope of Formula I as in instant claim 1 wherein,
R1 is 6 membered monocyclic heteroaryl (4-pyridinyl);
R2 is C1 alkyl (methyl);
X1 is CR3, R3 is H;
X2 is CH;
X3 is CR3, R3 is H;
Y is phenyl;
which satisfies the proviso that wherein each 5-6 membered monocyclic heteroaryl independently have 1-4 ring heteroatoms independently selected from N, O, and S.
Further, this satisfies the limitations of claims 2-4, 10, 14-16, 31 and 33.
Claims 1-4, 10, 14-16, 31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-2536123-19-8 (31/54), entered 29 November 2020, in the IDS.
Regarding instant claim 1, Database Registry compound, RN-2536123-19-8 teaches the following compound.
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The above compound falls within the scope of Formula I as in instant claim 1 wherein,
R1 is a 5 membered monocyclic heteroaryl substituted with one Ra, Ra is C1 alkyl (methyl) (1-methyl-1H-pyrazol-3-yl);
R2 is C1 alkyl (methyl);
X1 is CR3, R3 is H;
X2 is CH;
X3 is CR3, R3 is H;
Y is phenyl;
which satisfies the proviso that wherein each 5-6 membered monocyclic heteroaryl independently have 1-4 ring heteroatoms independently selected from N, O, and S.
Further, this satisfies the limitations of claims 2-4, 10, 14-16, 31 and 33.
Claims 1-4, 10, 14-16, 31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-2504855-12-1 (47/54), entered 05 November 2020, in the IDS.
Regarding instant claim 1, Database Registry compound, RN-2504855-12-1 teaches the following compound.
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The above compound falls within the scope of Formula I as in instant claim 1 wherein,
R1 is a 6 membered monocyclic heteroaryl (2-pyrazinyl);
R2 is C1 alkyl (methyl);
X1 is CR3, R3 is H;
X2 is CH;
X3 is CR3, R3 is H;
Y is phenyl;
which satisfies the proviso that wherein each 5-6 membered monocyclic heteroaryl independently have 1-4 ring heteroatoms independently selected from N, O, and S.
Further, this satisfies the limitations of claims 2-4, 10, 14-16, 31 and 33.
Additionally, compounds 25/54-28/54, 30/54, 32/54-46/54 and 48/54-54/54, all entered before the effective filing date of the instant claims are encompassed within the scope of Formula I as in instant claim 1 and read on the limitations of instant claims 2-3, 10, 14-16, 25, 31 and 33. Therefore, the registry compounds 25/54-28/54, 30/54, 32/54-46/54 and 48/54-54/54 anticipate instant claims 1-3, 10, 14-16, 25, 31 and 33.
Claims 1, 14-16, 25 and 69 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marsilje et al. (US 2008/0194668 A1, publication date 14 August 2008, hereinafter Marsilje, in the IDS).
Regarding instant claim 1, Marsilje teaches compounds of Formula I with variables as defined (Para. [0007]).
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Marsilje teaches the exemplary compound of Example 1 (Para. [0082]).
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Example 1 of Marsilje falls within the scope of Formula I as in instant claim 1, wherein
R1 is phenyl substituted by one Ra, Ra is -C(O)OR11, R11 being H;
R2 is H;
X1 is CR3, R3 is H;
X2 is CH;
X3 is CR3, R3 is halogen (fluoro);
Y is phenyl substituted with one Z group, Z being C4 alkyl (butyl).
Further, this satisfies the limitations of claims 14-16 and 25. Marsilje teaches a pharmaceutical composition which contains a compound of Formula I or a N-oxide derivative, individual isomers and mixture of isomers thereof, or a pharmaceutically acceptable salt thereof, in admixture with one or more suitable excipient (Para. [0015]). Thus, Marsilje anticipates the pharmaceutical composition of instant claim 69.
Claims 1, 14-16, 31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (US 2015/0236272 A1, publication date 20 August 2015, hereinafter Park, in the IDS).
Regarding instant claim 1, Park teaches the following compound (Paras. [0231]-[0232]).
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The above compound of Park falls within the scope of Formula I as in instant claim 1, wherein
R1 is phenyl;
R2 is H;
X1 is CR3, R3 is H;
X2 is CH;
X3 is CR3, R3 is H;
Y is phenyl substituted with one Ra group, Ra being -NO2.
Further, this satisfies the limitations of claims 14-16, 31 and 33.
Claims 1, 14-16, 31, 33 and 69 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldstein et al. (US 2008/0194668 A1, publication date 14 August 2008, hereinafter Goldstein, in the IDS).
Regarding instant claim 1, Goldstein teaches bisamidine compounds and pharmaceutical compositions thereof (Abstract). Goldstein teaches the pharmaceutical compositions comprise one or more of the above-described antiproliferative compounds of the present invention, or a pharmaceutically acceptable salt thereof together with a pharmaceutically acceptable carrier (Col. 7, Lns. 15-21). Goldstein teaches the following exemplary compound, compound (6.0.3) (Col. 15, Lns. 15-24).
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The above compound of Park falls within the scope of Formula I as in instant claim 1, wherein
R1 is phenyl substituted with one Ra group, Ra being 5 membered monocyclic heterocyclyl (4,5-dihydro-1H-imidazo-2-yl);
R2 is H;
X1 is CR3, R3 is H;
X2 is CH;
X3 is CR3, R3 is H;
Y is a 5 membered monocyclic heterocyclyl (4,5-dihydro-1H-imidazo-2-yl);
which satisfies the proviso that wherein each 5-7 membered monocyclic heterocyclyl independently has 1-2 ring heteroatoms independently selected from N, O, and S.
Further, this satisfies the limitations of claims 14-16, 31 and 33.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 10, 14-16, 25, 31, 33, 64 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Dyckman et al. (WO 2019/126253 A1, publication date 27 June 2019, hereinafter Dyckman, in the IDS).
Regarding instant claim 1, Dyckman teaches substituted indole compounds of Formula (I) or salts thereof, for use as inhibitors of signaling through Toll-like receptor 7, or 8, or 9 and pharmaceutical compositions comprising such compounds (Abstract; Pg. 2, Lns. 21-25).
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Dyckman teaches pharmaceutical compositions comprising a pharmaceutically acceptable carrier and at least one of the compounds (Pg. 2, Lns. 26-29). Dyckman teaches the following exemplary compounds, compound 257 (Pg. 114, Table 1) and compound 417 (Pg. 137, Table 1).
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Compound 257 of Dyckman overlaps the scope of Formula I as in instant claim 1 wherein,
R1 is 6 membered monocyclic heteroaryl (pyridinyl) substituted with 2 Ra, each Ra being C1 alkyl (methyl);
R2 is C3 alkyl (isopropyl);
X1 and X3 are each CR3, R3 being H;
Y is a 6 membered monocyclic heteroaryl (pyridinyl) substituted with one Z, Z being 6 membered monocyclic heterocyclyl (piperazinyl);
which satisfies the proviso that wherein each 5-6 membered monocyclic heteroaryl independently have 1-4 ring heteroatoms independently selected from N, O, and S.
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Compound 417 of Dyckman overlaps the scope of Formula I as in instant claim 1 wherein,
R1 is phenyl substituted with 2 Ra, each Ra being -OR11, R11 being C1 alkyl (methyl);
R2 is C3 alkyl (isopropyl);
X1 and X3 are each CR3, R3 being H;
Y is a 6 membered monocyclic heteroaryl (pyridinyl) substituted with one Z, Z being 6 membered monocyclic heterocyclyl (piperazinyl);
which satisfies the proviso that wherein each 5-6 membered monocyclic heteroaryl independently have 1-4 ring heteroatoms independently selected from N, O, and S.
Compound 257 and 417 of Dyckman differ from the instant compounds of Formula I with respect to the position of attachment of the “Y” group (highlighted above).
According to MPEP 2144.09 (II), “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). In the instant case, the compounds of the instant invention are taught to be inhibitors of Toll-like receptors (TLRs) TLR7, TLR8 and TLR9 (Para. [0003]; Paras. [0006]-[0011]). The compounds of Dyckman are taught to be inhibitors of signaling through Toll-like receptor 7, or 8, or 9 (Pg. 2, Lns. 21-25). Here, the cited positional isomer of Dyckman is so close in structure that, correspondingly, the instant compounds would be expected to have very similar or identical utilities and functional properties, rendering it prima facie obvious.
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention in view of the teachings of Dyckman,
to have arrived at the closely-structurally-related compounds of the instant claims. Dyckman teaches substituted indole compounds of Formula (I) or salts thereof, for use as inhibitors of signaling through Toll-like receptor 7, or 8, or 9. The compounds of Dyckman are positional isomers of the instant compounds. The compounds of Dyckman and the instantly claimed compounds act as inhibitors of Toll-like receptors TLR7, TLR8 and TLR9. Therefore, one of ordinary skill in the art would be motivated to synthesize the positional isomers of Dyckman to obtain the instantly claimed compounds with a reasonable expectation that the resultant compounds would exhibit Toll-like receptors (TLR7, TLR8 and TLR9) inhibitory activity.
Compound 257 and 417 of Dyckman renders the compounds of instant claims 1-4, 10, 14-16, 25, 31, 33, prima facie obvious.
Regarding instant claim 64, compound 257 and compound 417 of Dyckman have close structural similarity to the following compounds of instant claim 64 (given side-by-side for comparison), differing with respect to the position of the “Y” group and the presence of a isopropyl group for R2 versus the methyl of the instant claim (i.e., a homolog). Dyckman teaches R1 of Formula I can be C1-4 alkyl (Pg. 7, Ln. 15), allowing for R1 to be methyl (R1 of Dyckman corresponds to R2 of the instant claims).
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Compound of instant claim 64
(instantly elected species)
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Compound of instant claim 64
According to MPEP 2144.09 (II), “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). In the instant case, as discussed above, the substituted indole compounds of Dyckman and the instant compounds share the same utility as inhibitors of signaling through Toll-like receptor 7, or 8, or 9. Dyckman teaches R1 of Formula I can be C1-4 alkyl, allowing for R1 to be methyl. In the absence of any unexpected properties, it would have been prima facie obvious to one of ordinary skill in the art to have modified the compounds of Dyckman to arrive at the compounds of instant claim 64 (shown above), including the instantly elected species of compound, with a reasonable expectation of success.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 10, 14-16 and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 8, 18, 20, 27, 31, 33, 40, 42-43, 50, 52 and 53 of co-pending Application No 18/268,440.
Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims are drawn to compounds having similar core structures.
The claims of the instant application are drawn to a compound of Formula I with variables as defined in instant claim 1 and a pharmaceutical composition thereof.
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The claims of the reference ‘440 application are drawn to a compound of Formula I with variables as defined in instant claim 1 of the reference application and a pharmaceutical composition thereof.
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There is considerable overlap in scope of the claims between the reference ‘440 application and the instant claims, rendering the instant claims prima facie obvious. Specifically, the following compound of claim 52 (Pg. 11 of claim set dated 12/22/2025) of the reference ‘440 application anticipates the compound of Formula I of instant claim 1.
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The above compound anticipates the compound of Formula I of instant claim 1, wherein
R is a 6 membered monocyclic heteroaryl (2-pyridinyl) substituted with one Ra, Ra being a 6 membered monocyclic heterocyclyl (piperazinyl);
R2 is C1 alkyl (methyl);
X1 is CR3, R3 being H;
X2 is CH;
X3 is CR3, R3 being H;
Y is a 9 membered fused bicyclic heteroaryl substituted with a Z, Z being C1 alkyl (methyl) (8‐methyl‐[1,2,4]triazolo[1,5‐a]pyridine).
The instant claims 1-2, 10, 14-16 and 69 are anticipated by claims 3, 8, 18, 20, 27, 31, 33, 40, 42-43, 50, 52 and 53 of co-pending ‘440 application since the instant claims are generic to the sub-genus/species claimed in the co-pending Application No 18/268,440.
The instant claims 1-2, 10, 14-16 and 69 and the claims 3, 8, 18, 20, 27, 31, 33, 40, 42-43, 50, 52 and 53 of the reference co-pending Application No 18/268,440 are therefore not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-4, 10, 14-16, 25, 31, 33, 64 and 69 are rejected.
No claims are allowed.
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/PADMAJA S RAO/Examiner, Art Unit 1627