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 a compound of claim 68 in the reply filed on 2026 June 4 is acknowledged. A search has been conducted for the scope of a compound of claim 68.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2024 March 26, 2024 May 15, 2025 September 25, and 2026 June 11 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 68-80 and 85-88 are objected to because of the following informalities: the moiety shown below is hard to read due to the overlapping text over the bond between the CR61R62 group and the nitrogen-containing bicyclic ring. Variable v should not overlap with the bond.
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Appropriate correction is required.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 87 and 88 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for treating pancreatic carcinoma, colorectal carcinoma, and lung cancer with a compound having the structure of claim 1 and non-enabling for treating the scope of cancers claimed with a compound having the structure of claim 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treating cancer associated with at least one of K-Ras G12[C,D,V, R, S, A], and/or K-Ras G13D, Q61H, and/or K-ras wild-type amplification with a compound of the structure below. Thus, the claims taken together with the specification imply that a compound encompassed by the structure below can treat a cancer associated with at least one of K-Ras G12[C,D,V, R, S, A], and/or K-Ras G13D, Q61H, and/or K-ras wild-type amplification.
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The state of the prior art and (4) the predictability or unpredictability of the art:
ZHANG (Expert Review of Vaccines, 2020, 19(2), 163-173) describes that KRAS mutations are related to the following cancers (page 166, table 1): pancreatic carcinoma, colorectal carcinoma, and lung cancer.
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Additionally, it is taught that more research is needed to understand the relationship of KRAS to cancer broadly (page 171, “Expert Opinion” section).
The relative skill of those in the art:
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in treating cancer associated with at least one of K-Ras G12[C,D,V, R, S, or A], and/or K-Ras G13D, K-Ras Q61H, and/or K-ras wild-type amplification).
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for treating pancreatic carcinoma, colorectal carcinoma, and lung cancer with a compound of claim 1.
The specification does not provide guidance for the treatment of the scope of cancers recited in claims 87 and 88 with a compound of claim 1.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to treatment of the scope of cancers recited in claims 87 and 88 with a compound of claim 1 and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Conclusion
Claims 81 and 82 are allowed. Claims 83 and 84 are free of the prior art with respect to the scope of the search done. Claims 68-80 and 85-88 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: DEFOREST (WO 2024009191, published 2024 January 11) describes a compound (page 18). This compound does not anticipate nor render obvious a compound of claim 1 due to the reference being published after and filed after the effective filing date of the examined application 2022 September 21.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 8:00 AM to 4:00 PM.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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