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 .
This is a second Non-Final Office Action to correct a restriction requirement that was improperly withdrawn.
Corrected Election/Restrictions
Applicant’s election without traverse of Group I, drawn to claims 1, 2, 4-10, 16, 20, 23-24, 26, 28, 30-32, 47, 51, 52, and newly added claims 53-73 in the reply filed 07/08/2026 is acknowledged. Applicants’ specie election without traverse of compound 121, drawn to claims 1, 2, 4, 7-10, 16, 20, 23, 24, 26, 28, 30-32, 47, 53-56, and 67 is acknowledged.
Claims 34, 37, 44, 48, and 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. The election was made without traverse in the reply filed on 07/08/2026.
Compound 121 is directed to an allowable product. Examiner expanded the search to include the full scope of the elected Group I (claims 1, 2, 4-10, 16, 20, 23-24, 26, 28, 30-32, 47, 51-73).
Priority
Acknowledgement is made that Instant Application 18/544,945, filed on 12/19/2023, claims priority from Provisional Application 63/501,320, filed on 05/10/2023, and from Provisional Application 63/433,987, filed on 12/20/2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 04/04/2024, 04/04/2024, 04/04/2024, 06/05/2025, 01/23/2026, and 07/08/2026 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claim Interpretation
Claim 4 recites the limitation “L3 of formula (i-a)”, which is understood to be distinct from “L3” of R1, as described in claim 1.
Claim 67 recites the limitation “L3 of formula (I-a-1)”, which is understood to be distinct from “L3” of R1, as described in claim 1.
Claim 70 recites the limitation “L3 of formula (I-f-1)”, which is understood to be distinct from “L3” of R1, as described in claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 28 recites the limitation "
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". There is insufficient antecedent basis for this limitation in the claim because claim 2, from which the claim depends, does not allow for a –C(O)R group on the amine.
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beveridge (WO 2023/081441 A1. Published 05/11/2023. Priority claim to Provisional Application 63/276,927, filed on 11/08/2021).
Claims 1-2 are directed to compounds of Formula I, or a pharmaceutically acceptable salt thereof as inhibitors of cyclic GMP-AMP synthase (cGAS)
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wherein the structural limitations of R1 – R4, Ring A, and m are provided below as necessary.
Beveridge teaches compounds of Formula II, and pharmaceutically acceptable salts, hydrates, solvates, prodrugs, stereoisomers, labeled isotopes, or tautomers thereof in the treatment of cGAS-related diseases and disorders
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The difference between Beveridge and the Instant Application is that Beveridge fails to teach an anticipatory embodiment over instant Formula I.
However, Beveridge teaches an overlapping genus. For example, a preferred embodiment is disclosed, wherein Ring A is selected as
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(page 23, paragraph 114;page 23 paragraph 116; and claim 15).
The resulting genus overlaps with the genera of instant claims 1-2 when:
R1 is a 5-membered monocyclic heteroaryl;
R2 is H;
m is selected as 2;
each R3 is independently selected as either NH(R6) or N(R6)(R7) and OR8;
When R3 is NH(R6), R6 is selected as C1-C6 alkyl, C2-C6 alkenyl, C2-C6 alkynyl, C3-C8 cycloalkyl, or 4- to 10-membered heterocyclyl;
When R3 is N(R6)(R7), either R6 or R7 is C1-C6 alkyl and the other of R6 or R7 is C1-C6 alkyl, C2-C6 alkenyl, C2-C6 alkynyl, C3-C8 cycloalkyl, or 4-to 10-membered heteroaryl; and
R8 is C1-C6 alkyl, C2-C6 alkenyl, C2-C6 alkynyl, C3-C8 cycloalkyl, or 4- to 10-membered heteroaryl.
One of ordinary skill in the art would have been motivated to arrive at the overlapping subject matter because structurally similar compounds are expected to have similar properties. Further, Beveridge points to groups such as the 5-membered monocyclic heteroaryl and the substituted lactone as being effective cGAS inhibitors.
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 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 and 15 of co-pending application No. 18/706,884, filed 05/02/2024. Although the claims recited are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not yet been patented.
Claims 1-2 are directed to compound of Formula I, or a pharmaceutically acceptable salt thereof as inhibitors of cyclic GMP-AMP synthase (cGAS)
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Claim 1 of the co-pending application is directed to compounds of Formula II, or a pharmaceutically acceptable salt, hydrate, solvate, prodrug, stereoisomer, labeled isotope, or tautomer thereof (abstract)
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Claim 15 of the co-pending application is directed to compounds of Formula II, or a pharmaceutically acceptable salt, isomer, solvate, prodrug or tautomer there, wherein Ring A can be selected as
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The resulting co-pending genus overlaps with the genera of instant claims 1-2 when:
R1 is a 5-membered monocyclic heteroaryl;
R2 is H;
m is selected as 2;
each R3 is independently selected as either NH(R6) or N(R6)(R7) and OR8;
When R3 is NH(R6), R6 is selected as C1-C6 alkyl, C2-C6 alkenyl, C2-C6 alkynyl, C3-C8 cycloalkyl, or 4- to 10-membered heterocyclyl;
When R3 is N(R6)(R7), either R6 or R7 is C1-C6 alkyl and the other of R6 or R7 is C1-C6 alkyl, C2-C6 alkenyl, C2-C6 alkynyl, C3-C8 cycloalkyl, or 4-to 10-membered heteroaryl; and
R8 is C1-C6 alkyl, C2-C6 alkenyl, C2-C6 alkynyl, C3-C8 cycloalkyl, or 4- to 10-membered heteroaryl.
Claim Objections
Claim 28 is objected to because it contains a typo wherein two iterations of the structure
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are present. Appropriate action is required.
Claims 4-10, 16, 20, 23, 24, 26, 30-32, 47, 51-73 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art to the Instant Application is Beveridge (WO 2023/081441 A1. Published 05/11/2023. Priority claim to Provisional Application 63/276,927, filed on 11/08/2021).
Claim 1 is directed to compound of Formula I, or a pharmaceutically acceptable salt thereof as inhibitors of cyclic GMP-AMP synthase (cGAS).
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wherein the structural limitations of R1 – R4, Ring A, and m are provided below as necessary.
Beveridge teaches compounds of Formula II as cGAS inhibitors (abstract)
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Specifically, Beveridge teaches compound 64 (page 62) and compound 206 (page 63). Table 1 shows the structures of the disclosed compounds of Beveridge as well as Instant compound 121 as a representative example.
Table 1. Embodiments of Beveridge most similar to compounds of Instant Formula I.
Compound 64
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Compound 206
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Instant Compound 121
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Compound 64 is a compound of Formula II, wherein Ring A is a disubstituted δ-lactone moiety, in which the substituents are oxo and an amidyl thiadiazole.
The difference between compound 64 and compounds of Formula I is that Beveridge fails to teach an embodiment wherein Ring A is a trisubstituted δ-lactone moiety, in which the substituents are oxo, amino, and an amidyl thiadiazole.
However, Beveridge further teaches compound 206, wherein Ring A is a disubstituted δ-lactone moiety, in which the substituents are amino and an amidyl thiadiazole.
One of ordinary skill in the art would have been motivated to combine the compound 64 and compound 206 because Beveridge teaches Ring A is
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, wherein m is 0, 1, 2, or 3 (page 23, paragraph 114) and each R3 is independently -OR8 or -NH(R6), inter alia (page 27, paragraph 164). Said artisan would have found it obvious to synthesize a cGAS inhibitor wherein Ring A is a trisubstituted δ-lactone moiety (m = 2), in which the substituents are OH and NHPh.
The difference between the combined teachings of Beveridge and the Instant Application is that Beveridge fails to teach an embodiment wherein the oxo substituent is further substituted (e.g., C1 alkyl). The limitations of R1 of Formula I does not include H, and therefore the oxo substituent must be substituted. While the genus provided by Beveridge allows for R3 to be -OR8, no specific embodiments are provided to guide one of ordinary skill in the art to further modify that specific position. Therefore, further substituting the oxo substituent of the combined teachings would not have been obvious.
Furthermore, Beveridge fails to teach an embodiment wherein the amino substituent is not C6 aryl. The limitations of R2 and R3 of Formula I do not include C6 aryl. The genus provided by Beveridge further allows for R3 to be -NH(R6). However, no working examples are provided in which the amino substituent is further substituted with a group that overlaps with Formula I (e.g., optionally substituted C2 alkyl). As such, one of ordinary skill in the art would not have been guided to explore additional amino substituents.
The combined teachings of Beveridge further fail to teach where the thiadiazole is further substituted with a 5-membered monocyclic heteroaryl, as required by the limitations of Ring A of Formula I. Beveridge does not provide any examples in which the cGAS inhibitor is comprised of a substituted δ-lactone moiety and further comprised of a 5-membered monocyclic heteroaryl attached to the thiadiazole. Therefore, one of ordinary skill in the art would not have had motivation to substitute the m-chlorophenyl substituent of the combined teachings with a 5-membered monocyclic heteroaryl.
Accordingly, the recited compounds of Formula I are novel.
Conclusions
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Arcoria whose telephone number is (571)272-8719. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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