DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election without traverse of the invention of Group V (claims 11-14 and 16) in the reply filed on 08/14/2026 is acknowledged. Claims 1-10, 15 and 17-26 are withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Applicant further elected the Species of and antibody comprising SEQ ID NOS: 38, 39, 67-69 and 115-120. All presently recited species of the elected invention have been fully examined for patentability under 37 CFR 1.104.
Claims 11-14 and 16 are presently under consideration.
3. 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.
4. Claims 11-14 and 16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claims 11 and 12 are indefinite in the recitation of “CD3” because, as a person of skill in the art would be aware, CD3 complex is a protein cluster composed of four distinct polypeptide chains, i.e. gamma, delta, epsilon and zeta, and it is unknown which of these polypeptide(s) is/are within the scope of the claims.
(ii) Claims 11-14 are indefinite in the recitation of “binding arms,” because it is unknown what the arms bind to.
(iii) Claim 11 is indefinite in the recitation of “shields,” because the nature of structures or functions within the scope of the term is unknown.
(iv) Claims 11 and 16 are indefinite in the recitation of “protease sequences,” because SEQ ID NOs: 53-60 recited in claim 16 do not appear to encode proteases.
(v) Claims 12-14 and 16 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
5. The following is noted regarding the scope of presently claimed invention relative to the state of prior art:
The present invention is directed to a bispecific antibody comprising a CD3-binding arm comprising heavy and light variable regions (VH and VL) of an anti-CD3 antibody, and a CD38-binding arm comprising a VH-only domain. The claimed antibody is identified by specific CDR sequences (claim 11), as well as by at least 85% identity to the variable domain sequences (dependent claim 12).
Anti-CD3 antibodies almost identical to those recited in the present claims were known in the art before the effective filing date of the claimed invention. One of the presently recited anti-CD3 arms, “SP34 v8,” is based on anti-CD3 antibody SP34, as disclosed in the present specification ([0379] of US PG Pub. No. 20250277051). Bispecific anti-CD3, anti-CD38 antibodies comprising SP34 CD3-binding domain are taught e.g. by Blein et al. (US 20150133640, e.g. [0340], [0341]).
Prior art anti-CD3 antibody SP34 comprises VH of SEQ ID NO: 127 and VL of SEQ ID NO: 38 (specification at [0141]). Anti-CD3 arm “SP34 v8” comprises VH of SEQ ID NO: 39 and the same VL of SEQ ID NO: 38 (specification at [0379]), recited in claim 12, and comprises CDRs of SEQ ID NOS: 115-120, recited in claim 11. SEQ ID NO: 39 differs from SEQ ID NO: 127 by a single amino acid substitution at position 110 (S110A), which is within CDR3 of SEQ ID NO: 120 (see SCORE).
Nolte et al. (US 20190276551) teaches a VH-only CD38-binding domain of SEQ ID NO: 50 (MU551), which is differs from instant SEQ ID NO: 4 by one conservative amino acid substitution (99.2% identity) and comprises CDRs identical to instant SEQ ID NOS: 67, 68 and 69 (see SCORE). Accordingly, Nolte’s CD38-binding domain is structurally within the scope of the “second binding arm” recited in instant claims 11 and 12. Nolte also teaches bispecific antibodies binding to CD38 and a second antigen (e.g. [0524]).
To summarize, available prior art does not teach bispecific anti-CD3, anti-CD38 antibodies comprising the specific combinations of amino acid sequences recited in instant claim 11 or claim 12.
While prior art teaches combinations of elements identical or almost identical to those recited in the present claims, the present invention is deemed to be non-obvious over the available prior art, for the following reasons:
(i) prior art does not appear to provide a sufficiently specific suggestion or motivation to introduce the amino acid substitution S110A into CDR3 of known anti-CD3 antibody SP34, and
(ii) prior art does not appear to provide a sufficiently specific suggestion or motivation to combine the known CD38 binding domain with the specifically recited CD3-binding domains out of numerous known CD3-binding domains.
6. Conclusion: no claim is allowed.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
