DETAILED ACTION
Applicants claim amendments filed 4/17/2024 are acknowledged and entered into the record.
Accordingly, Claims 1-27 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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-27 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (WO/2022/010847 cited on IDS filed 4/17/2024) in view of Lazar et al. (US PgPub 2006/0024298 cited on IDS filed 4/17/2024).
The claims are drawn to an anti-MIC antibody comprising specific CDR/VH/VL sequences along with Fc mutations P329G, L234A, and L235A according to EU index. The claims are further drawn to nucleic acid encoding said antibody, a vector comprising said nucleic acid, a host cell comprising said vector and methods of treatment comprising administering said antibody.
Wu teaches anti-MIC antibodies comprising 100% identity to the claimed CDR/VH/VL SEQ ID NOs 1-10 of the instant application. Wu further discloses framework regions comprising “IMGT IGHV4-59*11”, “IGHV4-30-4*01”, and “IMGT IGKV1-5*01” (see paragraph [048]). Wu further discloses nucleic acids, vectors and host cells capable of expressing the MIC-antibody or polypeptide thereof. Wu et al. further disclose methods of treatment comprising administering said MIC-antibodies in dosage ranges as instantly claimed (see paragraph [0146]). Wu teaches substitutions within the Fc domain including L234A and L235A, however Wu does not teach the Fc point mutation P329G. This deficiency is made up for by Lazar et al.
Lazar et al. teach optimized Fc variants, Fc polypeptides comprising optimized Fc variants and method for making and using said variants. Lazar et al. disclose Fc point mutations including P329G, L234A and L235A. Lazar et al. also provides methods for engineering optimized Fc variants and provide experimental production and screening methods for obtaining optimized Fc variants. Lazar et al. indicate the variants provide substantial ADCC enhancements over WT at high, moderate, and low expression levels of target antigens and this result suggests that the Fc variants of the present invention may broaden the therapeutic window of anti-cancer antibodies.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application, to make the anti-MIC antibody taught by Wu, having a variant Fc region which for superior therapeutic performance based on the teachings of Lazar et al. that Fc variants which can be used to decrease binding affinity to Fcy receptors in order to increase half-life and other pharmacokinetics that may be useful for in vivo therapeutics. Therefore, one of ordinary skill in the art would have reasonable expectation of success, based on the teachings of Wu and Lazar et al. to make a more effective therapeutic by using Fc variants to improve stability and solubility for improved clinical use.
Conclusion
Claims 1-27 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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