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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 64-71, drawn to a compound of formula I, and the specific species
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in the reply filed on 8/11/2025 is acknowledged. Upon further consideration, the election of an invention has been withdrawn. The species election is maintained, but has been expanded to include at least
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(cmpd 163).
Claims 64-84 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The current application claims priority to PCTCN2020099104 filed on 6/30/2020 and PCTCN2021075828 filed on 2/07/2021. A careful review of the priority documents did not lend support for the elected species. Accordingly, Claims 64-68 have been given an effective filing date of 6/30/2021 consistent with the filing of PCT/CN2021/103372.
Information Disclosure Statement
The information disclosure statement filed on 12/16/2022 have been considered except where lined through.
Claim Objections
Claims 66, 68, 71, 74, 75, 77, 80 and 81 are objected to because of the following informalities: Each of the claims recite numerous chemical structures which are not separated by a comma.
Regarding claim 81, the claims make reference to compounds listed in Table A. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
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 64-84 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.
Regarding claims 64, 66, 70, 72, 74, 79 each of the claims recite phrases such as “e.g.” or “preferably” or “typically” or “etc.” which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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)(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.
Claim(s) 64-84 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Han et al. (US2004/0059710A1, 2024-02-22, Priority to at least PCT/CN2021/099750 filed 2021-06-11).
Han et al. teach KRAS G12D inhibitors of Formula (I), a composition containing the inhibitor and uses thereof, wherein the compounds have the general structure:
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(Abstract). Specifically, Han et al. teach a KRAS G12D inhibitors including, but not limited to,
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which is identical to the instantly claimed compound 163 in claim 81 (page 637). Moreover, Han et al. teach a pharmaceutical composition comprising the compounds in combination with a pharmaceutically acceptable excipient (paragraph 0147). With regards to the uses thereof, Han et al. teach a method of treating a subject having a disease or condition related to KRAS G12D mutant protein comprising administering to the subject a therapeutically effective amount of a compound of formula (I), wherein the disease or condition is cancer including, but not limited to, pancreatic, colorectal, endometrial and lung cancer (paragraph 0149).
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.
Claim(s) 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (US2024/0059710A1, 2024-02-22, Priority to at least PCT/CN2021/099750 filed 2021-06-11), as applied to claims 64-84 above.
Han et al. teach KRAS G12D inhibitors of Formula (I), a composition containing the inhibitor and uses thereof, wherein the compounds have the general structure:
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(Abstract). Specifically, Han et al. teach a KRAS G12D inhibitors including, but not limited to,
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which is identical to the instantly claimed compound 163 in claim 81 (page 637). Moreover, Han et al. teach a pharmaceutical composition comprising the compounds in combination with a pharmaceutically acceptable excipient (paragraph 0147). With regards to the uses thereof, Han et al. teach a method of treating a subject having a disease or condition related to KRAS G12D mutant protein comprising administering to the subject a therapeutically effective amount of a compound of formula (I), wherein the disease or condition is cancer including, but not limited to, pancreatic, colorectal, endometrial and lung cancer (paragraph 0149).
Han et al. does not specifically teach the elected species
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.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the compound
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taught by Han et al. to ring walk the methoxy over one carbon atom on the phenyl ring to arrive at
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. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
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). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
Conclusion
Therefore, No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-US20240034733A1
-US20230365563A1
-US20230081426A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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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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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626