DETAILED ACTION
Claim amendments filed 9/3/2024 is acknowledged and entered into the record.
Accordingly, Claims 1-2, 4-5, 15, 17-21, 33, 35, 40, 45-46, 54, 61-63, and 69 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 45 is 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 treating a B7-H3 expressing cancer, does not reasonably provide enablement for treating any and all cancers. 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 to a method of treating any cancer by administering the anti-B7-H3 antibody, enoblituzumab, to said subject. The art teaches that a specific antigen targeted by a therapeutic antibody must be expressed on malignant cells in order to be successfully targeted. White et al. (2001, Ann. Rev. Med., 2001, 52:125-145) teach that, for successful targeting and immunotherapy, besides specificity of the antibody for the antigen, other properties of the antigen should be considered including: the antigen should be present on all or near all of the malignant cells to allow effective targeting (p. 126, second paragraph). Furthermore, Meibohm (Pharmacokinetics and Pharmacodynamics of Biotech Drugs, Wiley-VHC, 2006, chapter 3, p. 45-91) teach that the target of an antibody must be as "unique" as possible for the disease to be treated. The antigen must be selectively expressed, or at least overexpressed at the target site. In cancer therapy, the tumor-specific antigen should be overexpressed only on the malignant cells/ tissue, but not on benign or healthy cells/ tissue. If the expression of the antigen is not exclusive in the target cells/ tissue, adverse reactions are more likely (p. 62-63, section 3.6). Therefore, it is established that in order for the anti- B7-H3 antibody, enoblituzumab, to treat cancer - the target cells must express B7-H3. The claimed method would not be successful in treating just any cancer specifically those which do not express B7-H3
Therefore, in view of the state of the art, the breadth of the claims, lack of guidance in the specification, and the absence of working examples for treating just any subject, it would require undue experimentation for one skilled in the art to practice the invention as broadly claimed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-5, 15, 17-21, 33, 35, 40, 45-46, 54, 61-63, and 69 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by NCT02923180 (cited on IDS filed 1/9/2024).
The claims are drawn to a pharmaceutical composition comprising specific concentrations of the enoblituzumab antibody, glacial acetic acid, sucrose, polysorbate 80 and water at a specific pH. The claims are further drawn to a container comprising said pharmaceutical composition and methods of treatment comprising administering said pharmaceutical composition.
NCT02923180 discloses a phase II trial of enoblituzumab (MGA271) in men with localized intermediate and high-risk prostate cancer. NCT02923180 disclose on page 34 last paragraph under “study treatment” the following:
“The MGA271 drug product is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow or pale brown solution supplied at a protein concentration of 25 mg/mL in a single-use 20 mL vial containing 17 mL (425 mg) MGA271. The product is formulated in 0.95 mg/mL sodium acetate trihydrate, 0.18 mg/mL glacial acetic acid, 90 mg/mL sucrose, 0.1 mg/mL polysorbate 80 and Water for Injection, United States Pharmacopeia (USP) at a pH of 5.1.”
The protocol of NCT02923180 disclose administration of the pharmaceutical composition by intravenous infusion over 120 minutes once a week. The NCT02923180 protocol further discloses dilution in 0.9% sodium chloride and inverting the infusion bag to mix the solution (see “Drug Preparation”). NCT02923180 teaches each and every limitation of the instant claims.
Conclusion
Claims 1-2, 4-5, 15, 17-21, 33, 35, 40, 45-46, 54, 61-63, and 69 are rejected.
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEERA NATARAJAN whose telephone number is (571)270-3058. The examiner can normally be reached M-F 9AM - 5PM.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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