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 of the invention of Group I (claims 1-7) in the reply filed on 12/23/2025 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 8-15 are withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-7 are presently under consideration.
3. The following is a quotation 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.
4. Claims 1-7 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that mAb 103.2 is required to make and use the claimed invention. As a required element, it must be known and readily available to the public or obtainable by a repeatable method set forth in the specification. If it is not so obtainable or available, the enablement requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the cell line which produces this antibody. See 37 CFR 1.801-1.809.
The above requirement is deemed to be satisfied by the following statement at page 10 of the present specification:
“The inventors have deposited a murine anti-CD277 antibody (mAb 103.2) producing hybridoma at the Collection Nationale de Cultures de Microorganismes (CNCM, Institut Pasteur, 25 rue du Docteur Roux, 75724 Paris Cedex 15, France), in accordance with the terms of Budapest Treaty, on Nov. 24, 2010.
The deposited hybridoma for mAb 103.2 has CNCM deposit number I-4403.”
In addition to the conditions of the Budapest Treaty, applicant is required to provide assurance that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent in U.S. patent applications. As additional means for completing the record, applicant is invited to submit a copy of the contract with the depository for maintenance of the deposit.
5. The following is noted regarding potential issues of nonstatutory double patenting.
Instant claim 1 is directed to an anti-CD277 antibody comprising the 6 CDRs of mAb 103.2 which is obtainable from hybridoma deposited at CNCM under number I-4403. Claim 2, which depends on claim 1, recites a humanized version of said antibody.
(i) The claims of U.S. Patent No. 12/247075 are directed to an anti-BTN3A antibody (e.g. claim 1). A person of skill in the art would be aware that CD277 is an art-recognized synonym of BTN3A protein, specifically BTN3A1, which is also disclosed at page 2 of the present specification.
In particular, of US ‘075 recites an anti-BTN3A antibody comprising H-CDRs 1-3 of SEQ ID NOS: 1-3, and L-CDRs 1-3 of SEQ ID NOS: 4, 17 and 6, respectively (claim 1).
Table 10 of US ‘075 discloses that SEQ ID NOS: 1-6 are the 6 CDRs of mAb 103.2, and as such are identical to the 6 CDRs the anti-CD277 antibody of instant claim 1. Table 10 of US ‘075 further discloses that SEQ ID NO: 17 is a humanized version of mAb 103.2 L-CDR2.
According to Table 11 of US ‘075:
L-CDR-2 of mAb 103.2 SEQ ID NO: 5 YASQSIF
L-CDR-2 of humanized mAb 103.2 SEQ ID NO: 17 YASQSAF
Based upon available information, there does not appear to have been sufficiently specific teaching or suggestion in the art before the effective filing date of the presently claimed invention to modify the sequence of L-CDR-2 as claimed in US ‘075 (SEQ ID NO: 17) so as to arrive at the at the L-CDR-2 sequence of the presently claimed antibody (disclosed as SEQ ID NO: 5 in US ‘075). Therefore, the present claims are deemed not to be subject to the ground of nonstatutory double patenting rejection.
(ii) The claims of copending application USSN 18/705452 (published as US 2025/0129165) recite an anti-BTN3A antibody comprising H-CDRs 1-3 of SEQ ID NOS: 17-19 and L-CDRs 1-3 of SEQ ID NOS: 20-22, respectively (claim 4(iii)). The respective amino acid sequences are listed in Table 10. As visually ascertained, SEQ ID NOS 17-22 of USSN ‘452 are identical to SEQ ID NOS: 1-4, 17, and 6, respectively, of US 12247075 described in subsection 5(i) above, and as such neither anticipate not make obvious the presently claimed invention for the same reasons as presented in subsection 5(i) above, and as such are deemed not to be subject to the ground of nonstatutory double patenting rejection.
(iii) Pending application USSN 18/862768 (published as US 2025/0353909) recites an anti-BTN3A antibody comprising H-CDRs 1-3 of SDEQ ID NO: 1-3 and L-CDRs 1-3 of SEQ ID NOS: 4, 23 and 6, respectively (claim 13(iv)), which are listed in Table 8, and are identical to SEQ ID NOS: 1-6 disclosed in Table 11 of US 12247075 (described in subsection 5(a) above), i.e. the 6 CDRs of instantly claimed mAb 103.2.
Based upon available information, the present application does not share a coinventor or an assignee with USSN ‘768, and as such the present claims are deemed not to be subject to the grounds of provisional nonstatutory double patenting rejection.
(iv) The following US Patents share a coinventor and/or an assignee with the present application, and disclose the subject matter of the present claims, but do not contain patented claims which would anticipate or make obvious the presently claimed invention:
US 10716838
US 11572409
US 11904004
US 11945871
US 11987631
US 12258400
6. The following documents are cited of record as pertinent to the present invention:
The following prior art document teaches anti-CD277 antibody 20.1 disclosed in the present application, but does not beach the presently claimed antibody 103.2:
Compte et al. (2004) Characterization of BT3 molecules belonging to the B7 family expressed on immune cells. Eur. J. Immunol. 34: 2089–2099.
The following post-filing date documents teach the presently claimed anti-CD277 antibody 103.2:
Palakodeti et al. (2012) The Molecular Basis for Modulation of Human Vgamma9Vdelta2 T Cell Responses by CD277/Butyrophilin-3 (BTN3A)-specific Antibodies. Journal of biological chemistry, 287(39): 32780-32790.
Harly et al. (2012) Key implication of CD277/Butyrophilin-3 (BTN3A) in cellular stress sensing by a major human gamma delta T cell subset. Blood, 120(11): 2269-2279.
7. Conclusion: no claim is allowed.
8. 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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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644