DETAILED ACTION
The amendment submitted on October 15, 2025 has been entered. Claims 36, 38-45, 47-58 are pending in the application. Claim 51-52, 54-55, and 58 are rejected for the reasons set forth below. Claims 36, 38-45, 47-50, 53, and 56-57 are allowed.
This communication includes at least one new ground of rejection that was neither necessitated by applicant’s amendment of the claims, nor based on information submitted in an information disclosure statement. Therefore, this Office action is non-final. See MPEP 706.07(a) (Final Rejection, When Proper on Second 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 . 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.
Allowable Subject Matter
Claims 36, 38-45, 47-50, 53, and 56-57 are allowed.
Withdrawn Rejections
The rejection of claims 36, 38, 40-41, 43-50, and 53-54 under 35 U.S.C. 103 as being unpatentable over Corey et al., WO 2010/123545 A2 is withdrawn because the limitations of claim 37, which was not rejected on this basis, have been incorporated into the independent claim.
Maintained Rejections Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obvious-ness 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) resolv-ing the level of ordinary skill in the pertinent art; and (4) considering objective evidence present in the application indicating obviousness or nonobviousness. See MPEP 2141 et seq.
Claims 51-52 and 55 remain rejected under 35 U.S.C. 103 as being unpatentable over Corey et al., WO 2010/123545 A2.
Corey (cited in the prior action) discloses the following compound (see the discussion of compound “EJC-16” at p. 60):
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Note the double bond indicated by the arrow, above. The reference also discloses (see, e.g., p 4, ll. 14-15 and p. 8, l. 1) that the double bond in question may alternatively be a single bond. When considering the teachings of Corey, “it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” See MPEP 2144.01. It is also proper to consider the “creative steps that a person of ordinary skill in the art would employ.” See MPEP 2141.03. Among the creative steps that the artisan would employ is simple substitution of one functional group for another equivalent functional group taught by a reference. Importantly, “[a]n express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious.” See MPEP 2144.06(II) (substituting equivalents known for the same purpose). The implicit disclosure of the reference is that a double bond and a single bond are more or less equivalent at this location in the chemical structure. By substituting the double bond in EJC-16 for an equivalent single bond as instructed by the reference, one arrives at the compound of instant claim 51. With respect to claim 52, Corey discloses pharmaceutical compo-sitions at p. 19, l. 4 through p. 21, l. 34. With respect to claim 54, Corey discloses a method of treating cancer at p. 17, ll. 2-15. The examiner therefore concludes that the subject matter of claims 51-52 and 55 is prima facie obvious. Applicant’s Remarks submitted on October 15, 2025 do not address this issue, so this rejection is maintained with respect to claims 51-52 and 55.
New Grounds for Rejection Claim Rejections – 35 USC § 112
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 54-55 and 58 are rejected under 35 U.S.C. 112(a) because the specification does not reasonably provide enablement for treatment of any and all cancers within the scope of the claims at issue. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement require-ment and whether any necessary experimentation is “undue.” These factors include, but are not limited to: the breadth of the claims; the nature of the invention; the level of one of ordinary skill; the level of predictability in the art; the state of the prior art; the amount of direction provided by the inventor; the existence of working examples; and the quantity of experimenta-tion needed to make or use the invention based on the content of the disclosure. See MPEP 2164.01(a).
The breadth of the claims encompasses using compounds of Formula (I) for “treating cancer,” that is, any cancer without limitation. As such, the nature of the invention is one of a panacea or “cure all,” which one of skill in the art would not view as credible. The examiner’s search of the prior art reveals that there is no known pharmaceutical composition that is effective at treating any and all cancers. One of ordinary skill in the art, e.g., someone with advanced training or significant professional experience in the field of medicinal chemistry, pharmacology, or a related technical discipline, would have viewed the instant claims with skepticism, especially in light of the low level of predictability in the pharmaceutical arts.
The “predictability” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily foresee the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily foresee the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. This will especially be the case where the statement is, on its face, contrary to generally accepted scientific principles, such as in the present situation where claims are directed to a panacea. See MPEP 2164.03.
The search of the prior art reveals that the claimed compounds have no known pharma-ceutical utility. In the absence of this information, one would look to applicant’s specification for information about how the compounds are made and used. Applicant provides process for making the compounds (see the synthesis at pp. 67-79). Applicant also includes kinase IC50 data for some of the compounds (see specification at pp. 79-80; see also Fig. 2 in the drawing and the discussion thereof). Applicant generally assert that these compounds are useful for treating cancers associated with CDK dysregulation (specification at pp. 2-3).
In the area of cancer treatment, however, the prior art teaches that “targeting a single hallmark or pathway with a single drug (‘magic bullet’) will not likely lead to cancer cure.” See Zugazagoitia et al., Clin. Ther. 2016;38(7):1551-66 at p. 1564. This reference discloses (see, e.g., Table I at p. 1554 and Table II at p. 1556, as well as the discussion thereof) that different cancers are treated with different drugs, so one would not find it credible that the drugs of the instant claims would be useful in treating all cancers.
Nowhere does applicant provide a rational explanation for why one would expect the compounds of Formula (I) to be useful for any and all diseases commensurate in scope with the breadth of the claims at issue. In light of the low level of predictability in the pharmaceutical arts, and the lack of direction and working examples in applicant’s specification, the examiner concludes that one of skill in the art would be burdened with undue experimentation when attempting to practice the invention as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/ interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
December 31, 2025