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 17 July 2026, wherein claims 73-74, 88-90, and 97 were amended; and claim 75 cancelled.
Claims 1-72, 75-87, and 92-93 are cancelled.
Claims 73-74, 88-91, and 94-102 are under consideration.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 17 July 2026 was filed after the mailing date of the Non-Final Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objections Withdrawn
Drawings
4. The objection to the drawings because the “Figure 2” label is not in the same orientation as the drawing itself is withdrawn in view of Applicant’s amendments.
Nucleotide and/or Amino Acid Sequence Disclosures
5. The objection to the figures for having sequences without sequence identifiers is withdrawn in view of Applicant’s amendments.
Specification
6. The objection to the abstract for usage of phrases that can be implied is withdrawn in view of Applicant's amendments.
7. The objection to the disclosure for sequences that are too short for sequence identifiers is withdrawn in view of Applicant’s amendments.
8. The objection to the disclosure for containing an embedded hyperlink and/or other form of browser-executable code is withdrawn in view of Applicant’s amendments.
Claim Objections
9. The objections of claims 73-75, 88, and 90-91 for informalities are withdrawn in view of Applicant’s amendments.
Rejections Withdrawn
Claim Rejections – 35 USC § 112
10. The rejections of claims 73-75, 88-91, and 94-102 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn in view of Applicant’s amendments.
11. The rejection of claim 75 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, is rendered moot in view of Applicant’s amendments.
12. The rejection of claims 88-90 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for isolated vectors and cells, does not reasonably provide enablement for unisolated vectors and cells is withdrawn in view of Applicant’s amendments.
Claim Interpretation
13. The amendment to claim 73, which now reads “wherein the antibody or the antigen-binding fragment thereof comprises a heavy chain variable domain (VH) paired with a light chain variable domain (VL)…”, is being interpreted as the antibody has the VH and VL on the same molecule, but the antigen-binding fragment does not necessarily have both due to the presence of the “or” language.
Rejections Maintained
12. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections – 35 USC § 112
13. Claims 73-74, 88-91, 94-99, and 101-102 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s Arguments: Applicant argues that the amendments now require the VH paired with the VL and thus the antibody and antibody-binding fragment are both defined by a full set of six CDRs.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive with respect to the issue below.
The rejection of claim 75 is rendered moot in view of Applicant’s amendments. However, as discussed supra, the antigen-binding fragment embodiment does not necessarily have both the VH and VL due to the “or” language. Thus, claim 73 and its dependents rejected above still read on a fragment that does not require all six parental CDRs and so this rejection stands.
14. Claims 73-74, 88-91, 94-99, and 101-102 are 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. 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 argues that the amendments now require the VH paired with the VL and thus the antibody and antibody-binding fragment are both defined by a full set of six CDRs.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive with respect to the issue below.
The rejection of claim 75 is rendered moot in view of Applicant’s amendments. However, as discussed supra, the antigen-binding fragment embodiment does not necessarily have both the VH and VL due to the “or” language. Thus, claim 73 and its dependents rejected above still read on a fragment that does not require all six parental CDRs and so this rejection stands.
Examiner suggests adjusting the phrase “antibody or antigen binding fragment thereof” in line 2 of claim 73 to recite “and” instead of “or”. Alternatively, the term “each” can be added after thereof.
Conclusion
15. 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.
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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
