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 .
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 33-39 and 47 is 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 33-39, the compounds of formula II-VIII renders the claim indefinite because it is unclear whether the limitations of R1-R2 and R4-R6 are of the same limitations of claim 1 since claim 1 is directed to a compound of formula I. Claims 33-39 depend from claim 1 but fails to specify if the R1-R2 and R4-R6 are of the same embodiments as of claim 1. For the purpose of prior art examiner is interpreting the above claims to have the same embodiments as of claim 1 in terms of R1-R2 and R4-R6.
Claim 47 recites the limitation "The method according to claim 45 " in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 45 as illustrated by the amended claims is canceled, thus the limitation of “the method according to claim 45” is of insufficient antecedent basis of being dependent from a canceled claim.
For prior art purposes, examiner is interpreting the above limitation to be “The method according to claim 44”.
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.
Claims 1, 16, 24, 29, 31, 33-35, 37-38, 40-42, 44, 47-48, 50 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (WO 2022155941 A1).
Regarding claims 1, 16, 24, 29, 31, 33-35, 37-38, 40-42, 44, 47-48, 50 and 55, He teaches a method for treating a disease or disorder associated with CDK2, comprising administering to the patient a therapeutically effective amount of a compound of Formula (I)
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, a pharmaceutically acceptable salt, or a stereoisomer thereof, and a pharmaceutically acceptable carrier to inhibit the activity of CDK2 (relevant to claims 42, 48 and 55) (Page 3, 3rd para.). He teaches the composition being administered orally to treat the optionally claimed cancers of breast cancer, HER2+/HER- metastatic breast cancer, lung cancer, ovarian cancer and acute myeloid leukemia (relevant to claims 44 and 47) (Page 3, 3rd para.) and in certain embodiments the compound is administered with a second therapeutic agent selected from a list which includes letrazole, fulvestrant and temozolomide (relevant to claim 50) (Page 3, 5th para., Page 59-60)).
Of the above Formula (I) He teaches compound 8
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, compound 30
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compound 101
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, compound 144
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101
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and compound 207
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wherein to claimed invention R5 is an alkyl (relevant to claim 24), R2 is C1-C6 alkyl (relevant to claim 29) and R1 is F or CF3 (relevant to claims 31).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have constructed the compounds of claims 33-35, 37-38 and 40-41 of
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of claimed invention from the teachings of He. One would be motivated to do so from the above structures taught by He, on that the substituents on the thiazole ring are of positional isomers thus having similar properties as of MPEP 2144.09 (II): 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). The compounds taught by He are CDK2 inhibitors as the instantly claimed compounds and there is no evidence illustrated by claimed invention that the isomers are unexpectedly better than the compounds of He. There is a reasonable expectation of constructing the compounds of claims 33-35, 37-38 and 40 of claimed invention from the teachings of He as CDK2 inhibitors to treat the same claimed cancers .
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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