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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 3-4, and 6, and species (A) VL/VH domain pair of SEQ ID NO: 50 and 54 in the reply filed on March 31, 2026 is acknowledged.
Claims 4, 6-15, 21-24, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1 and 3 are under consideration in this office 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. The application is the national stage entry of PCT/US2021/062708, which claims benefit to U.S. Provisional Application No. 63/123,433, filed December 9, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 10, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
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.
Claim 3 is 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 3 recites “the CD19 scFv comprises or consists of the amino acid sequence of SEQ ID NO:1”. The language of the claim (i.e. “comprises or consists”) is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement. “Consisting of” is close-ended and excludes any additional element, whereas “comprising of” is open-ended and allows for additional elements. As written, the precise limitations and scope of these claims are unclear; appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180312588A1, published November 1, 2018 (“Wiltzius”; see instant PTO-892.
The claims are directed to a polypeptide comprising a single chain variable fragment (scFv) that targets CD19. The scFv of SEQ ID NO: 1 is comprised of a variable light chain region (SEQ ID NO: 50), a spacer, and a variable heavy chain region (SEQ ID NO: 54).
Wiltzius teaches a humanized anti-CD19 scFv [0079] of SEQ ID NO: 26. This scFv has a light chain variable region comprised of three complementarity determining regions (CDRs) of SEQ ID NOs: 27-29 [0017] and a heavy chain variable region comprised of CDRs of SEQ ID NOs: 32-34 [0019]. These six CDRs in Wiltzius SEQ ID NO: 26 are identical to those found in instant SEQ ID NO: 1. See alignment below (boxes indicating six CDRs), where Qy is instant SEQ ID NO: 1 and Db is SEQ ID NO: 26 of Wiltzius.
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Wiltzius also teaches the spacer of SEQ ID NO: 7, which is identical to the spacer of instant SEQ ID NO: 1 (GSTSGSGKPGSGEGSTKG starting at position 110). Thus, Wiltzius teaches a scFv comprised of the same anti-CD19 antigen binding domain and the same spacer from instant claim 1 and 3.
Wiltzius teaches that the variability in antibody sequence is concentrated in the CDRs, while the more highly conserved regions in the variable domain are called framework regions (FR); the CDRs of the light and heavy chains are primarily responsible for the interaction and specificity of the antibody with the antigen [0116]. The differences in sequence identity between the scFv of Wiltzius and the scFv claimed are only in the framework regions.
Given that Wiltzius teaches the antigen binding domain of the scFv, it would have been obvious to one of ordinary skill in the art that the scFv of Wiltzius is the same as that claimed. The ordinary artisan would be able to modify the framework regions of the scFv to arrive at the claimed polypeptide comprising SEQ ID NO: 1 using methods already known in the art. Wiltzius teaches the process of antibody humanization, where the non-human antibody frameworks are replaced with those from human [0248]. For example, GenScript® provides a method for humanizing antibodies; the method follows combining CDR-grafting, structure-based back mutation method, and fast Screening for expression level, biophysical properties, and affinity technology (FASEBA), which generates a humanized antibody, e.g., scFv with affinity and optimized properties [0250]. Thus, methods for humanizing murine antibodies and optimizing these antibodies were well known in the art at the time the application was filed. See MPEP 2143.02.II: The court held the claimed method would have been obvious over the prior art relied upon because one reference contained a detailed enabling methodology, a suggestion to modify the prior art to produce the claimed invention, and evidence suggesting the modification would be successful. The ordinary artisan would recognize the modification of framework regions is a part of routine optimization and would be able to carry out such a substitution via methods known in the art. Without evidence of unexpected results or a teaching away, the claimed polypeptide is obvious over the teachings of Wiltzius.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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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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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675 /AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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