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
This is a response to Applicant’s communication filed on September 13, 2024. Application No. 18/847,166, filed September 13, 2024, is a 371 of PCT/KR2023/003519, filed March 16, 2023, and claims foreign priority to Korean application No. KOREA, REPUBLIC OF 10-2022-0033007, filed March 16, 2022. In a preliminary amendment filed September 13, 2024, Applicant cancelled claims 1-22 and added new claims 23-38. Claims 23-38 are pending.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 33-38 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for a method for , wherein the disease mediated by checkpoint kinase 2 activation is cancer, in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of the compound, or stereoisomer, hydrate, solvate or pharmaceutically acceptable salt thereof according to claim 23, the specification does not reasonably provide enablement for preventing or treating any disease mediated by checkpoint kinase 2 activation. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Factors to be considered when determining whether claims in an application for patent are enabling include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims are drawn to preventing and treating any disease mediated by checkpoint kinase 2 activation. The specification teaches that the claimed compounds show cell proliferation inhibitory activity, specifically inhibitory activity toward chk2. (Specification, p. 58-63.) However, there is no evidence indicating the prevention of diseases mediated by checkpoint kinase 2 activity. In addition, the prior art fails to provide compensatory guidance. There is no correlation between the inhibition of chk2 and preventing a condition mediated by the same. Similarly, there is no correlation between chk2 inhibition and treating any disease other than cancer. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
Conclusion
Claims 23-32 are allowable.
Claims 33-38 are not allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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