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 .
Priority
The instant application is a 371 National Stage Entry of PCT/CN2022/076671 filed on February 17, 2022 which claims priority to foreign application Nos. CN202210129460.9 filed on February 11, 2022, CN202110815600.3 filed on July 19, 2021, and CN202110192274.5 filed on February 19, 2021.
Status of Claims
Acknowledgement is made of original (1-3, 5, 6, 8, 10, 13, 15-17), amended (4, 7, 9, 11-12, 14, 18-21), and cancelled (22-23) claims filed on July 20, 2023. Claims 1-21 are pending in instant application.
Information Disclosure Statement
The information disclosure statements filed on July 20, 2023; September 7, 2025; and November 22, 2025 have been considered.
Claim Interpretation
Claims 1 and 17 recite the phrase “capable of”.
For example, claim 17 recites that two adjacent R4 on ring B are “capable of forming” a heterocycloalkyl, which is understood to be optional. Claim 17 is still satisfied by an R4 selected from the list in claim 14. The phrase “capable of” is being interpreted as an optional limitation.
Claim Rejections - 35 USC § 112(b)
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 1-8, 10-13, 15-21, 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.
Claim 1 recites structural limitations for R11 and R12, however Formula (1) in claim 1 does not appear to require R11 or R12. Claims 2-8, 10-13, 15-21 do not resolve the issue of indefiniteness and are incorporated in instant rejection. Claims 9 and 14 reference R11 and R12 limitations. The Examiner suggests amending to move the R11 and R12 limitations to the claims which recite them (e.g. from claim 1 to both 9 and 14).
Claim 10 recites “
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” at line 5. It is unclear what the structural limitation is.
Claim Rejections - 35 USC § 102
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.
Claims 1-5, 7-15, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/112344 A1 to Kim et. al.1
Regarding claims 1-5, 7-15, 17 and compounds of Formula I, Kim teaches Compound 15, also known as CAS# 2349336-32-7 (see Kim at p. 25 lines 31-32 and at p. 19 ¶[239]).
Kim
CAS# 2349336-32-7
Instant Formula (1)
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CAS# 2349336-32-7 reads on instant Formula (1) when A is C6-14 aryl specifically phenyl, R1 and R2 are both C1-C6 alkyl specifically methyl, X is N, Y is halogen specifically chlorine, Z is NH, B is C6-C14 aryl specifically phenyl, s is 2, one R4 is OR8 and R8 is C1-C6 alkyl specifically methyl, another R8 is 3- to 15-membered heterocycloalkyl specifically piperidine substituted with a 3- to 15-membered heterocycloalkyl specifically methylpiperazine or R8 is
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, q is 1, R3 is H.
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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claims 1-5, 7-15, 17 above.
Recall Kim teaches CAS# 2349336-32-7.
The prior art differs from the instant claims as follows: While Kim teaches a compound wherein
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is
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, Kim does not specify wherein
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is
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as in claim 18.
However,
The structural difference is isomeric.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.09(I)-(II), “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities” because “[c]ompounds which are…isomers…are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties” (see, e.g., MPEP § 2144.09(I)-(II)), and the Court has stated that “[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR, 127 S.Ct. at 1740.
Furthermore, it is well-within the ordinary skill in art to make an isomeric change to a known compound.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Conclusion
Claims 1-21 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Published June 13, 2019. Filed December 6, 2018. Hereinafter Kim.