DETAILED ACTION
Claims 1-21 are currently pending in the instant application.
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 .
Priority
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Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claim 21 is objected to because of the following informalities: It does not end in a period. 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 14-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treatment of cancer in a subject in need thereof which comprises administering a therapeutically effective amount of a compound of claim 1, does not reasonably provide enablement for prevention of cancer in need thereof which comprises administering a prophylactically effective amount of a compound 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/use the invention commensurate in scope with these claims. 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/use the invention commensurate in scope with these claims.
"Each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description." MPEP 2163(II)(1), citing In re Morris,127 F.3d 1048, 1053-1054; 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). Accordingly the scope of diseases claimed to be treated would be all types of cancerous tumors, ranging from breast cancer, prostate cancer, lung cancer, etc. Given the scope of the many types of cancerous tumors included within claims 15-19, their varied etiologies, and the diversity of their patient populations, the disclosure in the Specification is insufficient to permit a person skilled in the art to employ a compound for the purpose of treating or preventing the scope of the disorders as claimed.
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).
In In re Wands. 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The nature of the invention
In the instant case, the nature of the invention is for a method of treatment and/or prevention of cancer comprising administering a compound of formula (V).
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening invitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat or prevent cancer). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that that contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any preventive regimen on its fact.
MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” In Ex parte Stevens, 16 USPQ2d 1379 a claim to “A method for therapeutic or prophylactic treatment of cancer in mammalian hosts” was refused because there was “no actual evidence of the effectiveness of the claimed composition and process in achieving that utility.”
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427F.2d833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. With specific reference to cancer, Ex parte Kranz, 19 USPQ2d 1216, 1219 notes the “general unpredictability of the field [of] …anti-cancer treatment.” In re Application of Hozumi et al., 226 USPQ 353 notes the “fact that the art of cancer chemotherapy is highly unpredictable”. The burden of enabling one skilled in the art to prevent cancer would be much greater than that of enabling the treatment of cancer. In the instant case, the specification does not provide guidance as to how one skilled in the art would accomplish the objective of preventing or treating all cancers. Nor is there any guidance provided as to a specific protocol to be utilized in order to show the efficacy of the presently claimed active ingredients for preventing or treating all cancers.
"To prevent" actually means to anticipate or counter in advance, to keep from happening etc. (as per Webster's II Dictionary) and there is no disclosure as to how one skilled in the art can reasonably establish the basis and the type of subject to which the instant compositions can be administered to order to have the "prevention" effect. There is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with cancer in general. Since applicants "preventive" assertion is contrary to what is known in medicine, proof must be provided that this revolutionary assertion has merits.
The state of the prior art is that cancer therapy remains highly unpredictable. Cancer is not a single disease, or cluster of closely related disorders. There are hundreds of cancers, which have in common only some loss of controlled cell growth. Cancers are highly heterogeneous at both the molecular and clinical level, something seen especially in, for example, the cancers of the breast, brain and salivary glands. They can occur in pretty much every part of the body. The various types of cancers have different causative agents, involve different cellular mechanisms, and consequently, differ in treatment protocol. It is known that the challenge of cancer treatment has been to target specific therapies to pathogenetically distinct tumor types and that cancer classification has been based primarily on morphological appearance of the tumor. Tumors with similar histopathological appearance can follow significantly different clinical courses and show different responses to therapy (Golub et al, page 531).
According to information from the National Cancer Institute, targeted cancer therapies, is a type of cancer treatment that targets proteins that control how cancer cells grow, divide, and spread (see http://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/targeted-therapies-fact-sheet, accessed 04/20/2026). Most targeted therapies are either small-molecule drugs or monoclonal antibodies. They treat cancer by interfering with specific proteins that help tumors grow and spread throughout the body. Drugs for some targets are hard to develop due to target’s structure, target’s function in the cell, or both. Targeted therapies are specific to treat specific cancers. Due to the unpredictable nature of cancer and the fact that over 3,000 different cancers exist, the various types of cancers have different causative agents, involve different cellular mechanisms, and differ in treatment protocol, thus no single compound exists presently that is known to treat all cancers as a blanket therapeutic.
Cancer prevention is action taken to lower the chance of getting cancer. By lowering the chances, one is unable to definitively prevent cancer, especially since cancer is not a single disease but a group of related diseases. According to the National Cancer Institute, many things in our genes, lifestyle and environment may increase or decrease our risk of getting cancer. Thus, cancer prevention is not linked to one single factor and cannot be predicted with certainty (see 'Cancer Prevention Overview', https://www.cancer.gov/about-cancer/causes-prevention/patient-prevention-overview-pdq#_290, accessed 05/15/2026).
The amount of direction or guidance and the presence of working examples
The specification does not provide examples of treatment and prevention of cancer. It states that the compounds bind to mutated KRAS which inhibited protein-protein interaction (see p. 108-110) along with other cellular assays.
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure, specifically, the instant claims include treatment and prevention of cancer. However the specification only provides evidence that the compounds inhibit KRAS and therefore may treat certain types of cancer.
The quantity or experimentation needed and the level of skill in the art
It would require undue experimentation of one of ordinary skill in the art to ascertain the effectiveness of the compound in prevention or treatment of cancer. Factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instant case for the method use and composition with intended use claims.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, it is apparent that undue experimentation is necessary because of variability in prediction of outcome that is not addressed by the present application disclosure, examples, teaching and guidance presented. Absent factual data to the contrary, the amount and level of experimentation needed is undue.
Allowable Subject Matter
Claims 1-13 and 20 are allowed. Prior art such as WO 2021/245055, pub. 09/12/2021 and filed 06/01/2021 teaches compounds having an additional substituent on the 6 membered ring comprising U, V and W. Further WO 2018/140599 teaches compounds that modulate KRAS protein for treatment of cancer but does not teach utilizing compounds having ring A connected to the 6 membered ring of the instant application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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