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 .
Claim Status
Claims 1, 2, 4, 8-10, 13, 16, 23, 27, 29-31, 34, 37, 39, 40, 45-49, 57, 58, 66, and 67 are
pending.
Claims 3, 5-7, 11, 12, 14, 15, 17-22, 25, 26, 28, 32, 33, 35, 36, 38, 41-44, 50-56, 59-65,
and 68-70 are cancelled by a preliminary amendment filed on 01/02/2026.
Claims 2, 8, 9, 9, 13, 16, 23, 29-31, 34, 37, 39, 40, 47, 48, 49, 57, 58, 66, and 67 are
currently amended by a preliminary amendment filed on 01/02/2026.
Claims 1, 2, 4, 8-10, 13, 16, 23, 27, 29-31, 34, 37, 39, 40, 45-49, 57, 58, 66, and 67 have
been examined.
Claims 57, 58, 66, and 67 are rejected.
Claims 1, 2, 4, 8-10, 13, 16, 23, 27, 29-31, 34, 37, 39, 40, and 45-49 are allowable.
Priority
Priority to 371 PCT/US2023/066259 filed 04/26/2023, which claims priority to applications 63/403,661 filed on 09/02/2022 and 63/335,687 filed on 04/27/2022 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 02/11/2025 and 04/13/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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 57, 58, 66, and 67 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
To be enabling, the specification of the patent 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 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).[1]
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, state and predictability of the art, and relative skill level
The invention relates to treating inflammatory diseases, allergic diseases, autoimmune diseases, and/or cancer. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of art. For example, the results in one type of cancer treatment may not necessarily apply to other types of cancers. As illustrative of the state of the art, the examiner cites Abdellateif et al. (c-Kit Receptors as a Therapeutic Target in Cancer: Current Insights, Published 09/27/2023), which teaches “c-KIT is still controversial as it varies according to the type of the tumor, as either gain or loss of function” (page 793, paragraph 3) and “c-KIT is implicated in different types of cancer, and it could be a successful molecular target; however, proper detection of the underlying mutation type is required before starting the appropriate personalized therapy” (abstract). Also, Carlino et al. teach “selective inhibition of c-Kit is effective in treating patients with c-Kit mutant gastrointestinal stromal tumors, but c-Kit inhibitor activity has been disappointing in c-Kit mutant melanoma patients” (abstract).
The breadth of the claims
The claims are extremely broad and encompass the treatment of all inflammatory, allergic, autoimmune, and/or cancers, a diverse group diseases with distinct biological mechanisms.
The amount of direction or guidance provided and the presence or absence of working examples
The amount of direction or guidance provided in the specification regarding the use of the compound across this entire breadth is insufficient. Given the lack of working examples and complexity and unpredictability of the art, a person skilled in the art would be required to engage in undue experimentation to practice the invention as broadly as claimed.
The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used to treat all types treating inflammatory diseases, allergic diseases, autoimmune diseases, and/or cancer as inferred by the claims and contemplated by the specification.
Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
Allowable Subject Matter
Claims 1, 2, 4, 8-10, 13, 16, 23, 27, 29-31, 34, 37, 39, 40, and 45-49 allowable. The closest prior art compound is taught in WO 2013/033167. However, applicant has shown in Table 3 of the instant specification shows the c-KIT IC50 is vastly improved where R3 is a halogen. Therefore, the instant claims are shown to have an unexpected properties when the R3 is a halogen over other R3 substitutions. For the foregoing reasons the instant claims are allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALI SOROUSH whose telephone number is (571)272-9925. The examiner can normally be reached M-F 9:30am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener can be reached at (571) 272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
[1] As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.
Prosecution Insights