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 .
Status of the Claims
The following Office Action is in response to Applicant’s communication dated 12/31/2025.
Claims 1, 3, 12, 19, 22, 27, 29, 37, 42, 47, 54-57, 60, 62-64, and 70 are pending.
Claim 1 is amended.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
This action is a second non-final rejection to address newly-applied 112(a) rejections.
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.
Claim 1, 3, 12, 19, 22, 27, 29, 37, 42, 47, 54-57, 60, 62-64, and 70 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 37, and 42 recite the limitation of “ a mutant of c-Kit comprising an activating mutation”. The specification recites that “In certain embodiments, the activating mutation is a gain-of-function mutation. In certain embodiments, the activating mutation is a mutation whose gene product consists of an enhanced effect as compared to a gene product without such mutation (e.g., the wild-type protein).” And that “The activating mutation of c-Kit promotes proliferation and anti-apoptosis of cells comprising the c-Kit mutant. The activating mutation of c-Kit makes cells comprising the c-Kit mutant resistant to PD-L1/2-PD-1 inhibition.” (Specification [0120, 122]). However, the only actual examples of such a mutation appear to be those species of mutation recited in claim 3. The specification describes certain desired features of a potential mutation, but with over 900 amino acids comprising cKit there potentially several million or more potential mutations, which would require exhaustive experimentation for the skilled artisan to effectively discover. That is, the disclosed species of c-Kit mutations in the specification do not reasonably convey to the skilled artisan that the applicant was in possession of every mutation of c-Kit that could ever exist that would result in the claimed desired activating feature.
Claim 3 is similarly rejected, but only due to the limitation od item (i), “is within the intracellular region of human c-Kit”. Again, there are no specific mutations recited in this limitation, and even if this region were a handful of amino acids in length, there would still be hundreds, thousands, or millions of possible mutations available to choose from, exponentially increasing with the addition of each amino acid in the intracellular region.
All claims dependent on claim 1, 37, and 42 (3, 12, 19, 22, 27, 29, 47, 54-57, 60, 62-64, and 70 are rejected for being dependent on claim 1.
A suggested remedy for this rejection would be to import the specific mutations listed in claim 3 which are supported in the specification, namely limitations (ii-vii), and not limitation (i).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS RUSSE AMICK whose telephone number is (571)272-5474. The examiner can normally be reached 7:30-5 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS R. AMICK/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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