DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. This Office Action is in response to the amendment filed 14 April 2026, wherein claims 1-11 were amended. Claims 1-11 are under consideration and claims 12-20 are withdrawn.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 22 May 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Objections Withdrawn
Specification
4. The objection to the abstract for containing legal language is withdrawn in view of Applicant’s amendments.
Rejections Withdrawn
Claim Rejections - 35 USC § 112(b)
5. The rejection of claims 1-11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the wording of “the antibody or antigen-binding fragment thereof comprising” is withdrawn in view of Applicant’s amendments.
Claim Rejections - 35 USC § 112(a) - Enablement
6. The rejection of claims 7-11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for not being enabled for unisolated vectors and cells is withdrawn in view of Applicant’s amendments.
Rejections Maintained
Claim Rejections - 35 USC § 112(b)
7. Claims 1-11 remain rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the amino acid sequence having multiple interpretations of requiring the full sequence or a partial sequence thereof.
Applicant’s Arguments: Applicant argues that the removal of “containing a sequence” alleviates the indefiniteness of claim 1.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive with respect to the issue below.
The wording of “a CDR X of SEQ ID NO: Y” still leaves the claims indefinite. The claims could require the full sequence of the sequence identifier or a partial sequence thereof that is a CDR under a different labeling system or different antibody all together. Examiner suggests changing “of SEQ ID NO:” to “comprising SEQ ID NO:” for every instance in claim 1. Claims 2-11, which are dependent on claim 1, also remain rejected.
Claim Rejections - 35 USC § 112(a) - Enablement
8. Claims 1-11 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a monoclonal antibody comprising a full set of parental CDRs, does not reasonably provide enablement for any antibody molecule with fewer than all parental CDRs or mutated/truncated CDRs. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Applicant’s Arguments: Applicant states that the amendment of claim 1 from “An antibody or antigen fragment thereof” to “A monoclonal antibody” further defines that the antibody is monoclonal. Applicant further states that the CDRs are not mutated Kabat CDRs, but rather are defined by the IMGT scheme.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive with respect to the issue below.
The wording of “a CDR X of SEQ ID NO: Y” still makes it unclear if the claim requires the full sequence or a partial sequence thereof, as discussed supra. Claim 1 and its dependents rejected above still read on mutated/truncated CDRs for the reasons of record and so this rejection stands. It is acknowledged that the CDRs are defined by the IMGT numbering scheme. IMGT CDRs are used in US9701738 and US10465007 and so are enabled for defining a monoclonal antibody.
New Objections
Claim Objections
9. Claim 8 is objected to because of the following informalities: “isolated vector” is unclear since the vector will no longer be isolated once inserted into the isolated host cell. Examiner suggests removing “isolated” before “vector”. Appropriate correction is required.
Formal Matters
10. Due to the elected group not currently being allowable, no rejoinder may be considered at this time. It is noted that some groups do not appear to be eligible for rejoinder as they are not drawn to methods for making or using the claimed product.
Art-Free Subject Matter
11. A monoclonal antibody comprising all six CDRs of claim 1 is currently free of the prior art.
Conclusion
12. No claim is allowed. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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