DETAILED ACTION
Applicant’s amendments to the claims filed 12/22/2023 are acknowledged and entered into the record.
Claims 31-50 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 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 33 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 33 recites the phrase “preferably” rendering the claim indefinite because the claim include(s) elements not actually disclosed (those encompassed by “preferably”), thereby rendering the scope of the claim unascertainable.
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.
Claim(s) 31-50 are rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. (US Patent 9,718,880) in view of Chamberlain et al. (US Patent 8,088,376).
The claims are drawn to the anti-C5 antibody eculizumab comprising a VH and VL having SEQ ID NOs: 7 and 8, respectively having a variant human Fc constant region with greater affinity to FcRn than that of a native human Fc constant region. The claims are further drawn to specific Fc mutations, nucleic acid encoding said antibody, expression vector and host cell and methods of producing said anti-C5 antibody and methods of treatment.
Bell et al. teach eculizumab, a humanized monoclonal antibody against C5 that inhibits terminal complement activation. Bell et al. teach the anti-C5 antibody having 100% identity to instantly claimed VH and VL regions having instant SEQ ID NOs: 7 and 8 (see column 30). Bell et al. teach nucleic acids encoding the eculizumab anti-C5 antibody, expression vectors comprising said nucleic acid and a host cell used to produce said anti-C5 antibody. Bell et al. further disclose methods of treatment comprising administering the eculizumab anti-C5 antibody in patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as prior art teachings showing the beneficial effect of anti-C5 antibodies in systemic lupus, rheumatoid arthritis, autoimmune disease, cardiopulmonary bypass and acute myocardial infarction (see column 8). Bell et al. do not teach wherein the antibody has a variant Fc constant region with greater affinity to FcRn than that of the native human Fc constant region. This deficiency is made up for by Chamberlain et al.
Chamberlain et al. teach optimized IgG immunoglobulin variants directed to Fc variants of a parent polypeptide including at least one modification in the Fc region of the polypeptide and pharmaceutical compositions comprising said polypeptides for therapeutic purposes. Chamberlain et al. disclose the variant polypeptides exhibit enhanced binding to FcRn as compared to the parent as well as increased half-life. Chamberlain et al. disclose some of the following Fc variant modifications: 252Y, 259I, 307Q, 308F, 428L, 434S/A/H. Chamberlain et al. disclose the engineered variants bind with great affinity to human FcRn binding at pH6.0 relative to wild-type IgG1.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Fc constant region of the eculizumab anti-C5 antibody taught by Bell et al. to improve FcRn binding affinity for a better therapeutic antibody based on the teachings of Chamberlain et al. Combining the teachings of Bell et al. and Chamberlain et al. to make an anti-C5 antibody having a VH and VL comprising SEQ ID NOs: 7 and 8 respectively as taught by Bell et al. with Fc constant region mutations as taught by Chamberlain et al. and recited in the instant claims would result in an antibody having instantly claimed SEQ ID NO: 11, 13, 15, and 16. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success based on the teachings of Bell et al. of therapeutic treatment comprising administering the anti-C5 antibody eculizumab and Chamberlain et al. teaching variant Fc constant regions to improve FcRn binding affinity and enhance in vivo half-life.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 31 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 51 of copending Application No. 19/014,615 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
Claims 31-50 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643