DETAILED ACTION
The examiner for your application at the USPTO has changed. Examiner Abigail VanHorn can be reached at 571-270-3502.
Election/Restrictions
Applicant’s election without traverse of Group I and compound 10 in the reply filed on January 6 2026 is acknowledged. Claims 1-3, 6, 9-10, 13-15, 18, 20-24 and 31-32 are pending in the application. Claims 2-3, 6, 13, 18, 20, 24 and 31-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 6 2026. Accordingly, claims 1, 9-10, 14-15 and 21-23 are being examined on the merits herein.
The examiner notes that the response indicates claims 13, 18 and 20 read on the elected species but this is not the case. Claim 18 further limits formula II-a’ which contains attachment on the pentose at a different position than the elected structure. Claims 13 and 20 while reciting adenine do not include a chloro.
The examiner notes that an amended claim set was filed January 6 2026. This amended claim set does not utilize solid line strike-throughs but utilizes dotted line strike throughs. Since the MPEP does not appear to require a particular type of strike-through, the examiner interprets any dotted line going through the molecule as a strike-through indicating this subject matter was deleted from the claim. This is different than the squiggly line which is utilized to denote point of attachment.
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 .
Priority
This application is a 371 of PCT/CN2021/124704 (10/19/2021) which claims priority to CHINA 202011124067.8 (10/20/2020) and CHINA 202111201201.4 (10/15/2021).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 19 2023 and January 7 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The spacing of the lines of the specification is such as to make reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
Claim Objections
Claim 1 is objected to because of the following informalities: in the description of pentose reference is made to R2 but the actual structure includes R2. Therefore, the R2 should be changed to a R2 to match the actual description in the structure as well as throughout the other claims.
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Appropriate correction is required.
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 10 and 15 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 applications subject to pre-AIA 35 U.S.C. 112, 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 10 recites the broad recitation -NHC1-6 alkyl, and the claim also recites preferably -NHCH3 which is the narrower statement of the range/limitation. Claim 15 recites the broad recitation -NHC1-6 alkyl, and the claim also recites preferably -NHCH3 which is 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.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 9-10, 14-15, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Altman et al. (WO2017027645, cited on PTO Form 1449) in view of Wu (WO2018085307).
Applicant Claims
The instant application claims a cyclic dinucleotide compound of formula II. Specifically elected compound is
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Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Altman et al. is directed to cyclic dinucleotide compounds as sting agonists. Claimed is a compound of formula II:
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wherein Base1 and Base2 are independently selected and include:
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and
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. Y and Ya can be O. Xa, Xa1, Xb, Xb1, Xd and Xd1 can be O. Xc and Xc1 can be S. R2 and R2a can be H. R3a can be H, F or OH. R4 and R4a can be H, F or OH. R5 can be H, F or OH. R6 and R6a can be H, F or OH. R7 and R7a can be H, F or OH. R8 and R8a can be H, F or OH (claim 1).
Specific compounds claimed include:
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(claim 12) which are taught as possessing R stereochemistry (page 105; 113). Taught are racemic mixtures as well as individual enantiomers. The separation of a mixture of stereoisomers can be carried out. The invention includes all isomers (page 42). Taught are pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier (claim 3). The compounds and carrier or excipients will typically be formulated into a dosage form adapted for administration to a subject by a desired route of administration (page 50, lines 30-33).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Altman et al. teach the base can be
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and the pentose can be fluoro or hydroxy substituted, Altman et al. does not expressly teach a cyclic dinucleotide with those groups. However, this deficiency is cured by Wu et al.
Wu is directed to prodrugs of clofarabine. Compounds taught include formula I:
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wherein R1 and R2 can be H (paragraph 0009). Taught are pharmaceutical composition comprising the compounds including those for topical use such as creams, ointments, etc. (paragraph 0062). The compounds are taught as treating cancer (claim 11). Clofarabine is known to inhibit DNA synthesis at two critical junctures: DNA polymerase I as well as RNA reductase (paragraph 0002). The structure of clofarabine is shown (page 27):
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Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Altman et al. and Wu and utilize clofarabine as one of the nucleotides in the cyclic dinucleotide,
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. One skilled in the art would have been motivated to utilize clofarabine as it is known to be useful in treating cancer. Since Altman et al. also teaches the compositions for treating cancer and that the chlorine and fluorine substituents can be utilized there is a reasonable expectation of success. Based on the teachings of Wu et al., one skilled in the art would have been motivated to select these specific substituents from the teachings of Altman et al. to arrive at the instantly elected compound. Regarding the claimed stereochemistry, Altman et al. teaches R stereochemistry. Furthermore, Altman et al. teaches that invention includes all isomers. Rendering obvious claims 1, 9-10, 14-15 and 21.
Regarding claims 22-23, Altman et al. teaches the compounds can be in the form a pharmaceutical composition with a carrier, reading on excipient, and they can be formulated for any route of administration. Wu et al. teaches compositions for topical administration. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Altman et al. and Wu and utilize the composition in a pharmaceutical composition in the form of topical administration as this type is expressly taught by Wu and is a conventional route of administration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636