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 .
DETAILED ACTION
Claims 1-30 are pending in the instant application.
Claims 11, 13-17, 25-26, 29, 30 are withdrawn, as being drawn to a non-elected invention.
Claims 1-10, 12, 18-24, 27-28 are examined herein.
Priority
The instant application is a Continuation of International Application No. PCT/CN2024/083204, filed on 22 March 2024, which claims priority from International Applications No.
PCT/CN2023/083493, filed on 23 March 2023,
PCT/CN2023/094609, filed 16 May 2023,
PCT/CN2023/106428, filed 7 July 2023,
PCT/CN2023/109596, filed 27 July 2023,
PCT/CN2024/071631, filed 10 January 2024,
PCT/CN2024/076713, filed 7 February 2024, and
PCT/CN2024/079195, filed 29 February 2024.
Certified copies of the priority documents, in English, have been submitted on 14 October 2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 14 October 2025 and 2 April 2026 are acknowledged and considered.
Election/Restrictions
Applicant’s election without traverse of Group (I), claims 1-28, drawn to a pharmaceutical composition comprising a compound of formula (I), in the reply filed on 13 February 2026, is acknowledged. Claims 29, 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Applicants’ election without traverse of the compound below:
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as the species of a compound of formula (I)
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, for initial examination, in the Reply of 13 February 2026, is acknowledged.
The elected species is a compound of formula (I) for which the following definitions apply:
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Claims 1-10, 12, 18-24, 27-28 read on the elected species.
Since the election was made without traverse, the requirement for restriction/election is herein maintained and is made FINAL.
Applicant’s elected species is found free of the prior art. The examiner has extended the search to a subgenus of compounds of formula (I) encompassing the elected species, namely compounds of formula (I) where
X1 = X2 = N; R4=R5=H; substituents R1, Cy, R6, R2, R3 as in claim 1; and
Z is -C(O)C(O)NR11BR11C, and this subgenus is free of the prior art.
Claims 1-10, 12, 18-24, 27-28 have been examined and the following objections and rejections are made below.
Claims Objections
Claims 11, 13-17, 25, 26, 29, 30, while currently withdrawn, are objected to because of the following informality: The withdrawn claims are objected to for being presented in a non-compliant form. Specifically, the status identifier states the claim is “(Currently amended)”, or “(Original)”, but the claims are withdrawn because of the election made by the Applicant on 13 February 2026. As such, claims 11, 13-17, 25, 26, 29, 30 should be identified as "(Withdrawn)" until such time as examiner rejoins the claims for examination. Appropriate correction is required. See MPEP 714(C).
Claim 2 is objected to because there should be “or” between the two structures corresponding to the moiety listed, and there should be “or” between the last two structures listed in the claim.
Claim 3 is objected to because there should be “or” between the last two structures listed in the claim.
Claim 4 is objected to because there should be “or” between the last two substituents listed in the claim.
Claim 8, 20, 22, 24 are objected to because there should be “or” between the last two substituents or structures listed in the claim.
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.
Claims 1-10, 12, 18-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “isotopic variant” (of a compound of formula (I)), and the claim also recites “deuterated compound” (of a compound of formula (I)), and the claim also recites that R1 is, for example D, R3 is, for example, D, R4 and R5 are for example, D, R9 is, for example, D, etc., which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate clarification of the claim language is required.
Claims 3, 5-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Claim 3 is drawn to the compound of claim 1, wherein Cy is
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; yet claim 1 does not define Cy as spirocyclic or fused bicyclic; rather, claim 1 defines Cy as C5-C10 cycloalkylene, 5-14 heterocycloalkylene, C6-10 arylene or 5-10 membered heteroarylene. As such, the structures in claim 3 do not seem to find antecedent basis in claim 1.
Claims 5, 6 depend on claim 1and list R1 as being, for example,
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,
yet claim 1 does not recite spirocyclic or fused bicyclic structures in the definition of R1.
Further, it is unclear whether the R1 which is one of the most used moiety R1
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is encompassed by the definition in claim 1. Claim 1 states that R1 is 4-10 membered heterocycloalkyl; yet this moiety is not a fully saturated cycle. This seems to be a 6-membered heterocyclyl partially unsaturated comprising one ring heteroatom which is oxygen.
Appropriate clarification is required.
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 (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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10, 12, 28 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bordas et al. (WO 2022/249060, published 1 December 2022, cited in IDS).
Bordas et al. (WO 2022/249060) teach the following compound (page 610, the last compound in claim 25) and a pharmaceutical composition comprising said compound:
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, which is a compound of instant formula (I)
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of claims 1-10, for which the following definitions apply:
X1 = X2 = N; R4 = R5 = H (as in instant claim 9); R3 = H (as in instant claim 8);
R6 is ethyl (C2 alkyl), as in instant claim 10;
R1 is
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(as in instant claims 4?, 5, 6);
R2 is
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(as in instant claim 7);
Cy is
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(as in instant claim 3);
Z is -SO2R11; where R11 is 6-membered heteroaryl substituted with one R13 which is OH;
and is a compound of formula (IIi) of instant claim 12.
Bordas further teaches the following compounds and compositions thereof:
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.
The list is not exhaustive. These are compounds of formula (I)
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of the instant claims for which the following definitions apply:
X1 = X2 = N; R4 = R5 = H (as in instant claim 9); R3 = H (as in instant claim 8);
R6 is ethyl or methyl (C2 or C1 alkyl), as in instant claim 10;
R1 is, for example,
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(as in instant claim 5, 6);
R2 is, for example,
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(as in instant claim 7);
Cy is
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(as in instant claim 3); or substituted piperazine
Z is -COR; where R is 6-membered heteroaryl substituted;
and is a compound of formula (IIb) of instant claim 12.
Applicant has excluded by proviso some of the compounds in the prior art by Bordas, yet the proviso only refers to
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, not to the compounds above or to other many compounds disclosed by Bordas.
As such, a compound of instant claims 1-10, 12, 28 is anticipated by Bordas.
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 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 1-10, 12, 27, 28 are rejected under 35 U.S.C. 103 as being unpatentable over Bordas et al. (WO 2022/249060, published 1 December 2022, cited in IDS).
Bordas (WO 2022/249060) discloses the following compound (Embodiment 95, page 74)and compositions thereof:
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,
which is an isomer of a compound of instant claims 1-10, 12, 27, 28
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(page 25 of the claims, second compound on the first row).
Bordas also discloses the following compound (Embodiment 95, page 74):
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which is an isomer of a compound of instant claims 1-10, 12, 27, 28
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(page 24 of the claims, second compound on the first row).
In the absence of unexpected results, stereoisomers are considered obvious variants of each other. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Obviousness based on similarity of structure and function entails motivation to make claimed compound in expectation that compounds similar in structure will have similar properties. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979). Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979)
As such, claims 1-10, 12, 27, 28 are rejected as prima facie obvious.
Conclusion
Claims 1-10, 12, 18-24, 27-28 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S. LUNDGREN can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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