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 Group I (claims 15, 16 and 21-25) in the reply filed on 09/21/2026 is acknowledged. Claims 15, 16 and 18-25 are pending; claims 18-20 are withdrawn from prosecution for being drawn to non-elected subject matter. Claims 15, 16 and 21-25 are examined.
Information Disclosure Statement
The information disclosure statements (IDS)s submitted on 09/26/2023 and 03/11/2026 were 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 15, 16 and 21-25 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 claims contain 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.
The claims are drawn to a method of inducing an immune response in a subject in need thereof by administering to the subject an effective amount of a pharmaceutical
composition comprising a monoclonal antibody or antigen-binding fragment thereof that binds specifically to OPN, wherein the antibody comprises the heavy chain variable region (HCVR) sequences of SEO ID N0:7, and the light chain variable region (LCVR) of SEO ID N0:6, and wherein the pharmaceutical composition reduces OPN induced inhibition of T cell activation and induces an immune response. The T cells are CD8+ T cells. The immune response is the reduction of OPN signaling induced immune suppression which may lead to reduction of a tumor burden for cancer including bladder, brain, breast, cervical, colorectal, esophageal, hematological, hepatic, nasopharyngeal, pancreatic, prostate, skin, stomach, renal, testicular or uterine, and reduction of a metastatic tumor.
Applicant is basing the method claimed on the fact that interferon regulatory factor 8 (IRF8) functions as a repressor of OPN expression and loss of IRF8 expression in tumor cells leads to elevated expression of OPN which acts as a potent T cell suppressor. Therefore, reducing or blocking OPN signaling in tumor cells or the tumor microenvironment with OPN binding moieties is useful for treating cancer ([0063]). However, the guidance and the working examples do not, at any time, disclose the use of the antibody claimed for actually treating anything. The working examples use only cells that are either IRF8 knock outs or OPN knock out (See examples section). The only instance that the anti-OPN are used is an in vitro murine or human OPN neutralization assay.
While anti-Osteopontin antibody where known in the art, numerous references prophetically indicated the potential use of them in treating cancer. However, none of the reference indicated a positive example of actually treating tumors in vivo by using anti-osteopontin antibodies. The closest prior art is considered to be Kim et al. (Tumor-derived Osteopontin suppresses antitumor immunity by promoting extramedullary myelopoiesis. Cancer Res. 74, 6705-6716, 2014). The reference disclosed that anti-osteopontin enhances antitumor therapeutic effect of B cell-based immunotherapeutic vaccine in mice that were previously inoculated with MC8 or CT26 (colon cancer cells) (p. 6712-6713).
To be able to act in vivo, an antibody has to be fully vetted from the point of view of Pharmacokinetic point of view so as to ensure availability and efficacy for the effect sought after. according to the guidance, working examples and paucity of art references, it is apparent that such an endeavor is extremely improbable. A person of ordinary skill in the art would have to perform a vast amount of experimentation with unpredictable result in order to determine that the antibody claimed (which is new in the art) is effective for the method claimed. Such an amount is thus considered undue and the claims are not considered enabled.
If Applicants are in possession of in vivo experiments that could bolster their claims that are strongly encouraged to present them for critical evaluation.
Conclusion
No claim are 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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