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 .
Claims Status
The remarks filed 10/15/2025 are acknowledged.
Claims 1-31 are pending.
Claims 4-8, 10-11, 13, 17-21, 23-24, and 26-30 are amended.
Applicant’s election without traverse of the following species in the reply filed on 10/15/2025 is acknowledged: the multispecific antibody construct structure as recited in claim 1, SEQ ID NO: 4 for the first, second, and third linkers of the multispecific antibody construct, the scFv orientation as recited in claims 5 and 18, the binding specificity as recited in claims 7 and 20, and elected the CH3 domain mutations of T366W and T366S/L368A/Y407V.
Claims 6, 8-9, 14-26, 28, and 30-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/15/2025.
Therefore, claims 1-5, 7, 10-13, 27, and 29 are under examination.
Priority
The instant application is a 371 of PCT/US2020/061124 and claims priority to provisional application 62/937,729. Priority is given with the earliest effective filing date of 11/19/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/16/2024, 10/18/2024, and 06/23/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
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 1-5, 7, 10-13, 27, and 29 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 the limitation “…ii) an antibody heavy chain, the antibody heavy chain comprising a second VH, a second CH1 region…”. The “second CH1 region” is the first and only CH1 region mentioned in the claim, and thus, it is unclear if this is a second CH1 region in addition to another or if this should read as a “first CH1 region”. Therefore, the scope of this claim is indefinite.
Claims 2-5, 7, 10-13, 27, and 29, which depend from claim 1, are therefore indefinite for the same reasons as set forth above. For purposes of examination, the Examiner is interpreting this as being the first CH1 region since it is the only CH1 region referred to throughout the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5, 7, 10-13, 27, and 29 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bernett (US 20180127501; instant PTO-892).
Regarding claims 1-2, 10-11, 13, and 27, Bernett teaches bispecific antibodies that monovalently bind a human costimulatory receptor and monovalently bind a human checkpoint receptor, wherein the bispecific can have the format as depicted in Figure 2D [see 0007, 0011, and Figure 2D shown below].
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Bernett teaches the structure of the one armed mAb (depicted in Figure 2N which lacks the scFv of Figure 2D), comprising one monomer that comprises only an Fc domain (i.e. hinge region-CH2-CH3; first polypeptide consists of the Fc domain), and another monomer that is a heavy chain (i.e. VH1-CH1-hinge-CH2-CH3), and further has a variable light chain domain (VL) and a constant light (CL) domain that associate with the heavy chain to form a Fab (i.e. anti-antigen 2; second antigen binding domain) [0395]. Thus, the description of the structure of Figure 2N can be applied to Figure 2D, which depicts an scFv (i.e. VH and VL with a first linker; first antigen binding domain) attached by a linker (second linker) to the VH of the Fab [see Figure 2D]. As evidenced by Brezski et al., 2011 (instant PTO-892), the one-arm scFv-mAb of Bernett depicted in Figure 2D comprises a hinge region on both CH2 domains and depicts the scFv attached to the VH of the Fab [see page 1158, Figure 1 of Brezski]. Thus, the structure as shown in Figure 2D of Bernett is identical to the multispecific antibody construct instantly claimed.
Regarding claims 3 and 12, Bernett teaches that any linker is a “domain linker” used to link any two domains herein together, and a glycine-serine linker is utilized, such as (GGGGS)n, wherein n can be 3 [0215].
Regarding claim 4, Bernett teaches that the scFv linker can be SEQ ID NO: 26219, with is a (GGGGS)3 linker, that attaches the VH and VL [see 0019-0020, 0213; Figure 8B]
Regarding claim 5, Bernett teaches that the preferred scFv format, starting from the N-terminus, is VH-linker-VL [0155].
Regarding claim 7, Bernett teaches that the bispecific antibodies (i.e. the first antigen binding domain and the second antigen binding domain) bind to antigen pairs which each antigen is on a different protein [0007-0010].
Regarding claim 29, Bernett teaches that the Fc domains of the one armed mAb comprise a specific set of amino acid substitutions which can be T366S/L368A/Y407V:T366W [0397] and all constant region positions are numbered according to the EU index as in Kabat [0726].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675