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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-3, 5, 8, 10, 30-34, 36-43, and 48 have an effective filing date of 20MAY2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/16/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restriction
In the response filed on 8/27/2026, Applicant elected, without traverse:
Group I, claims 1-3, 5, 8, 10, 30-34, and 36-37
Species
SEQ ID NO: 1 as a species of amino acid sequence
IgG1 as a species of Fc domain isotype
Full-length antibody as a species of antibody moiety
Bispecific antibody as a species of compositions
An antigen on the surface of a T cell as a species of second antibody moiety that binds to a second antigen
HLA-A*02:01 as a species of HLA-A
Detectable label as a species of an agent
Status of Claims
Claims 1-3, 5, 8, 10, 30-34, 36-43, and 48 are currently pending and presented for examination on the merits.
Claims 3, 5, 8, 10, 30, 33-34, and 36-43 are amended.
Claims 38-43, and 48 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 4, 6-7, 9, 11-29, 35, 44-47, and 49-52 are canceled.
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.
Claims 1-3, 5, 8, 10, 30-34, and 36-37 are 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 1 recites a heavy chain immunoglobulin variable domain (VH) comprising a VH-CDR1 sequence, a VH-CDR2 sequence, and a VH-CDR3 sequence of the VH sequence of SEQ ID NO: 17, and a light chain immunoglobulin variable domain (VL) comprising a VL-CDR1 sequence, a VL-CDR2 sequence, and a VL-CDR3 sequence of the VL sequence SEQ ID NO: 18. The recitation of a CDR sequence encompasses fragments of a CDR sequence that may comprise, for example, only two amino acid residues. As such the metes and the bounds of the claim are unclear. Claims 2, 3, 5, 8, 10, 30-34, and 36-37 are included in this rejection, because these claims depend from claim 1 but do not cure the deficiencies of claim 1 with respect to 35 U.S.C. 112(b).
Applicant is informed that this issue may be overcome by amending claim 1 to recite a heavy chain immunoglobulin variable domain (VH) comprising the VH-CDR1 sequence, the VH-CDR2 sequence, and the VH-CDR3 sequence of the VH sequence of SEQ ID NO: 17, and a light chain immunoglobulin variable domain (VL) comprising the VL-CDR1 sequence, the VL-CDR2 sequence, and the VL-CDR3 sequence of the VL sequence SEQ ID NO: 18.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 claims a composition having at least 90% identity to a sequence selected from the group consisting of: SEQ ID NOs: 1-2, or 4-16. Claim 5 depends from claim 1. Claim 1 claims a composition that comprises CDRs from SEQ ID NOs: 17 and 18. The SEQ ID NOs: 1-2, 4-7, and 9-16 only comprise either CDRs from SEQ ID NO: 17 or CDRs from SEQ ID NO: 18. The SEQ ID NO: 8 does not comprise the CDRs from SEQ ID NOs: 17 or 18. Therefore claim 5 fails to further limit claim 1 and is rejected under 35 U.S.C. 112(d).
Conclusion
Claim 5 is rejected.
Claims 1-3, 8, 10, 30-34, and 36-37 are allowed.
Claims 38-43, and 48 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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