DETAILED ACTION
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 .
Claim Status
Claims 4-8, 12-19, 21, 24-28, 30, 32, 35, 38-50, 52, 55, 56, 58 and 60-63 have been cancelled.
Claims 1-3, 9-11, 20, 22-23, 29, 31, 33-34, 36-37, 51, 53-54, 57 and 59 are currently pending.
Claims 20, 22-23, 29, 31, 33-34, 36-37, 53-54, 57 and 59 have been withdrawn.
Claims 1-3, 9-11 and 51 are being examined in this application.
Election/Restrictions
Applicant’s election without traverse of Group I invention (Claims 1-3, 9-11 and 51) as well as species for the elected antibody (including SEQ ID NOs 2, 3, 6, 12-14, 8, 16, 21-23, 124) in the reply filed on 9/18/2025 is acknowledged.
Claims 20, 22-23, 29, 31, 33-34, 36-37, 53-54, 57 and 59 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/18/25.
Priority
This application is filed under 35 U.S.C 371 of PCT/US2021/028798 (filed on 4/23/2021), which claims priority to US provisional applications 63/015,149 (filed on 4/24/2020).
Information Disclosure Statement
The IDS filed on 1/6/26, 6/9/25, 7/17/24 and 10/21/22 have been considered. See the attached PTO 1449 forms.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01.
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 2-3, 9-11 and 51 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 2 recites “an amino acid sequence selected…” in lines 4 and 6 of the claim, which the term “an” renders the claim scope unclear since “an amino acid sequence” can be interpreted to mean any fragment of the listed SEQ ID NOs. It is recommended to amend the claim to recite “the amino acid sequence selected…”
Claim 9 recites various SEQ ID NOs for the HC and LC that are not in the alternative for each HC and LC. Specifically, the claim recites “…SEQ ID NO: 137, SEQ ID NO: 139...” for the heavy chain in line 4 of the claim, which is missing the term “or” before “SEQ ID NO: 139”. Similarly, the term “or” is missing before “SEQ ID NO: 130” in line 7 of the claim. Alternatively, the claim can be amended to recite “… a heavy chain (HC) amino acid sequence selected from the group consisting of SEQ ID NO: 23… and SEQ ID NO: 139”. Similarly for the light chain (LC) amino acid sequence.
Claim 3 depends on claim 2, and Claims 10, 11 and 51 depends on claim 9, which the said dependent claims do not clarify the issue of claim 9, and thus are rejected.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by Cheung et al (US2018273623; 9/27/2018; filed on 1/26/2018 or earlier; cited in IDS).
The instant claims recite an antibody or fragment thereof comprising various amino acid sequences for the VH and VL domains.
Cheung et al, throughout the reference, teaches various antibody and/or fragments thereof (e.g. Abstract; Sequence listing).
For Claim 1, Cheung et al teach a scFv of huOKT3scFv antibody fragment (a bispecific binding molecule) with SEQ ID No.58, for example. (e.g. page 161; [0032]), which contains the same amino acid sequences as the instant SEQ ID NOs 2, 3, 6 and 12-14 for the VH and VL CDRs respectively. See the sequence alignment below.
Sequence (1-letter amino acid codes):
1 QVQLVQSGGG VVQPGRSLRL SCKASGYTFT RYTMHWVRQA PGKCLEWIGY
===== === (SEQ ID NO.2)
51 INPSRGYTNY NQKFKDRFTI SRDNSKNTAF LQMDSLRPED TGVYFCARYY
======== (SEQ ID NO.3) ====
101 DDHYSLDYWG QGTPVTVSSG GGGSGGGGSG GGGSGGGGSG GGGSGGGGSD
======== (SEQ ID NO.6)
151 IQMTQSPSSL SASVGDRVTI TCSASSSVSY MNWYQQTPGK APKRWIYDTS
===== (SEQ ID NO.12) == (SEQ ID NO.13)
201 KLASGVPSRF SGSGSGTDYT FTISSLQPED IATYYCQQWS SNPFTFGCGT
==== ===== (SEQ ID No.14)
251 KLQITR
(HITS AT: 26-33, 51-58, 90-91, 97-108, 176-180, 198-199, 237-245)
Allowable Subject Matter
The instant claimed SEQ ID NOs as recited in Claim 2, 9, 10, 11, and 51 are free of prior art searched.
Conclusion and Correspondence
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUE LIU whose telephone number is (571)272-5539. The examiner can normally be reached M-F 9-5.
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/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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