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 .
DETAILED ACTION
1. Applicant's amendment, filed 11/21/25 is acknowledged.
2. Claims 1-21 are pending.
3. Applicant’s election without traverse of Group I, claims 1-21 in the reply filed on 11/21/25 is acknowledged.
Claims 1-21 read on a multi-specific antibody construct are under consideration in the instant application.
4. 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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.
5. 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.
6. Claim(s) 1-6, 9, 12-21 are rejected under 35 U.S.C. 102 (a) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US Patent Application 20170204176 in view of Miyata et al., (Mol. Evol.1979, v.12 pages 219-236
US Patent Application ‘176 teaches a multi-specific antibody construct comprising a first antigen binding site specific for the first tumor cell surface antigen that is B7homolog 3 ( B7-H3) and a second antigen-binding site specific for a second tumor cell antigen that is disialoganglioside ( GD2). US Patent Application ‘176 teaches that said multi-specific antibody construct can be conjugated to a therapeutic agent ( see entire document, paragraphs, 0030, 0053, 0052, 0743 in particular).
Although the reference is silent about binding Kbs of the first and second antigen binding sites or ADCC activity or has ADCC activity against a cell expressing B7-H3 and GD2 greater than ADCC activity against the cells expression only GD2 or that said multi-specific construct binds less to nerve cells as compare to dinutuximab, said functional properties would be an inherent properties of the references multi-specific antibody, because the references and the instantly claimed multi-specific antibody is the same. Since the office does not have a laboratory to test the reference antibodies, it is applicant’s burden to show that the reference multi-specific antibodies do not bind to B7-H3 and GD2 with the Kds as recited in the claims or has ADCC activity against a cell expressing B7-H3 and GD2 greater than ADCC activity against the cells expression only GD2 or that said multi-specific construct binds less to nerve cells as compare to dinutuximab. See In re Best, 195 USPQ 430, 433 (CCPA 1977); In re Marosi, 218 USPQ 289, 292-293 (Fed. Cir. 1983); In re Fitzgerald et al., 205 USPQ 594 (CCPA 1980).
Claims 9, 12 -14 are included because it would be obvious to one skill in the art that the reference antibody would have 3VH CDRs and 3VL CDRs
Claims 15-18 are included because the claimed amino acid substitution is considered to be conservation amino acid substitution and it would be obvious to one skill in the art to make said substitution to increase stability , affinity and/or half-life of said multi-specific antibody ( see Miyata et al., Mol. Evol.1979, v.12 pages 219-236)
The reference teaching anticipates or , the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
7. Claims 7,8,10 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
8. No claim is allowed.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644