DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 2/19/26 has been entered in full. Claims 1-2, 5-6, 13-14, and 21 are amended. Claims 1-21 are pending.
Applicants' election without traverse of Group I, claims 1-14 and 19-21, was previously acknowledged. Claims 15-18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-14 and 19-21 are under consideration.
Information Disclosure Statement
The Information Disclosure Statement of 2/19/26 has been considered.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (8/28/25).
The objection to the drawings at page 2 is withdrawn in view of the replacement sheets filed 2/19/26.
The objections to the specification at page 3 are withdrawn in view of the amendments to the specification.
The objections to claims 1-14 and 19-21 at pages 3-4 are withdrawn in view of the amendments to the claims.
Maintained Objections and/or Rejections
Claim Rejections - 35 USC § 112(a), written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.-The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 19-21 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection was set forth previously at pages 4-8 of the 8/28/25 Office Action.
Applicants’ arguments (2/19/26; page 14) as they pertain to the rejection have been fully considered but are not deemed to be persuasive for the following reasons.
In the response, Applicants request that the rejection “be reconsidered and withdrawn”, because that “the claims are adequately described because a skilled artisan considering the specification would have reasonably concluded that the inventors had possession of the instantly claimed antibody” (page 14).
Applicants’ arguments have been fully considered but are not found persuasive. Applicants’ argument, that the skilled artisan would have concluded that the inventors had possession of the claimed antibody, merely states the opposite conclusion of the rejection of record; i.e., that the skilled artisan would not held that Applicants have possession of the claimed invention. The rejection of record established a prima facie case reaching this conclusion, and supported by a reasoned explanation; see pages 4-8 of the Office action. Applicants’ arguments do not provide any specific reasons as to why the explanation that leads to this conclusion is wrong. As such, the rejection is maintained for the reasons of record.
New Claim Objections
Claim 6 is objected to because of the following informalities:
In claim 6, lines 2-3, the recitation “…wherein the heavy chain variable region comprising HVR-H1…” should be “…wherein the heavy chain variable region comprises HVR-H1…”
In claim 6, lines 6-7, the recitation “…wherein the light chain variable region comprising HVR-L1…” should be “…wherein the light chain variable region comprises HVR-L1…”
Appropriate correction is required.
Conclusion
Claims 5 and 7-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 extension fee 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 ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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