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 .
Response to Amendment
The Amendment filed 02/13/2026 in response to the non-final rejection of 11/17/2025 is acknowledged and has been entered.
Claims 1, 23-24, 30-35, 66-70 were amended or previously presented.
Claims 5-6 were cancelled.
Claims 1, 23-24, 30-35, 66-70 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Rejections Maintained
Claim Rejections - 35 USC § 112
Claims 23-24 remain rejected 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, or for failing to include all the limitations of the claim upon which it depends for the reasons of record in the action mailed 11/17/2025, paragraph 7.
Applicants argue (Remarks 02/13/26, page 1) that amendments to Claim 23 and 24 now limit the scope of claim 1. Claim 23 has been amended to recite that the amino acid sequence having at least 90% identity to the amino acid sequence of SEQ ID NO: 4 comprises the complementarity determining region 1 (CDR1), CDR2, and CDR3 of an anti-CD79b variable light chain comprising the amino acid sequence of SEQ ID NO: 4. Applicants further argue that claim 24 has been amended to recite that the amino acid sequence having at least 90% identity to the amino acid sequence of SEQ ID NO: 6 comprises the CDR1, CDR2, and CD3 of an anti-CD79b variable heavy chain comprising the amino acid sequence of SEQ ID NO: 6.
These arguments have been considered but are not persuasive. Independent claim 1 comprises the amino acid of SEQ ID NO:4 and the amino acid of SEQ ID NO:6. The amendments only add language that is already present in Claim 1, yet both of claims 23 and 24 still retain “at least 90%” identity to SEQ ID NO:4. Thus, claims 23-24 do not limit the scope of Claim 1.
Claims 1, 23-24, 30-35 remain rejected and new claims 66-70 remain rejected under the grounds of nonstatutory double patenting as being unpatentable over claims 1, 27-31, and 34-38 of copending application (now allowed but not issued) 17/312744 for the reasons of record and for the reasons set forth below.
Applicants argue (Remarks, page 2) that claim 1 has been amended to recite that the variable heavy chain of the CD79b-binding domain is N-terminal to the variable light chain of the CD79b-binding domain rendering them non obvious over co-pending application 17/312744.
This argument has been considered but is not found persuasive. The species of VH to VL scFv arrangement necessarily anticipates the genus of the co-pending application. Those of ordinary skill in the art readily understand that this is a very common arrangement in that scFv domains can be linked in either way (VH to VL, or VL to VH and still retain antigen binding function). This works because the linking domains (typically G4Sx3 linker) are long and flexible and allow proper assembly of the VH and VL to form the antigen recognition pocket in either orientation.
New Rejections
Claim Rejections - 35 USC § 112
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 23-24 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.
Claims 23-24 now recite “an amino acid sequence having at least 90% identity” to SEQ ID NO:4 or SEQ ID NO:6 and comprises the amino acid of SEQ ID NO:4 or 6. This is indefinite because the claims cannot both comprise all of the amino acids of SEQ ID NO:4 (or 6) and have at least 90% identity. For example, according to the as filed sequence listing, SEQ ID NO:4 is 112 amino acids long. Thus, according to claim 23 the structure must contain all 112 amino acids (including CDRs 1-3) while simultaneously being permitted to contain less than (at least 90%) 112 amino acids.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643