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
Claims 1-18 are pending and are currently examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/29/2023 was considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 7 and 15-18 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 treatment of cancer cells expressing mesothelin, does not reasonably provide enablement for prevention of any disease or treatment for any cancer which does not comprise mesothelin expressing cells. 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.
The claims are drawn an antibody, or a fragment thereof, specifically binding to mesothelin and which may be part of a Chimeric antigen receptor (CAR). The antibody is characterized by a complete set of CDRs. The antibody, as such, or part of a CAR, is comprised in a pharmaceutical composition or used for treating cancers that express mesothelin. The specification presents guidance and working examples for antibodies and methods of killing mesothelin expressing cancer cells. There is no guidance or working examples of treatment of cancer in general and is considered that the antibodies may be used to treat mesothelin expressing cancer cells only.
The claims broadly encompass “prevention” of a disorder. However, the phrase "preventing a disorder", given its broadest reasonable interpretation in light of the teachings in the specification, requires that absolutely no cell, nor tissue, or individual would present any symptom of a disorder after treatment with the antibodies claimed or a cell harboring a CAR comprising the antibodies. There is no evidence, either in the specification or in the prior art, that any method to date can accomplish this goal. The specification presents the results of experiments demonstrating that CAR-T cells may be useful for ). These data show that CAR-T cells comprising the antibodies claimed are able to kill H2052 mesothelin expressing cells (Example 7). However, there is no support for the prevention of any disorder or disease, as is required by the claims, and neither can such support be obtained through reasonable extrapolation of the data or teachings in the art.
If Applicant limits the claims to methods of treatment for mesothelin expressing cancers, the claims might become allowable.
Conclusion
Claims 1-6 and 8-14 are allowed. Claims 7 and 15-18 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
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