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 .
Applicant's arguments filed 7/21/2026 have been fully considered but they are not fully persuasive.
Claims 1-2, 5, and 21 have been cancelled. Claim 24 has been newly added.
The rejection of claims 3, 5-10, 12, 16, 18, and 22-23 under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (U.S. Patent Application Publication 2014/0004107, of record) is withdrawn in view of the claim amendments.
Election/Restrictions
Claims 13-15, 17, and 19-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/23/2025.
For clarity of the record, the species election set forth in the restriction requirement mailed 8/5/2025 has been withdrawn.
Claim 3, part (1), recites the 7D1 antibody CDRs. Claim 6, part (1), corresponds to the VH/VL sequences having these CDRs. See also claim 23, part (1). Claims 7, part (1), corresponds to the HC/LC having these CDRs. Claim 8, part (1), corresponds to the HC/LC having these CDRs.
Claim 3, part (2), recites the 3C6 antibody CDRs. Claim 6, part (2), corresponds to the VH/VL sequences having these CDRs. See also claim 23, part (2). Claim 7, part (2), corresponds to the HC/LC having these CDRs. Claim 8, part (2), corresponds to the HC/LC having these CDRs.
Claim 3, part (3), recites the 31C8 antibody CDRs. Claim 6, parts (3), (7), and (8), correspond to the VH/VL sequences having these CDRs. See also claim 23, parts (3), (7), and (8). Claim 7, parts (6), (7), and (8), correspond to the HC/LC having these CDRs. Claim 8, parts (6), (7), and (8) correspond to the HC/LC having these CDRs. See also claim 24.
Claim 3, part (4), recites the 26A1 antibody CDRs. Claim 6, part (4), corresponds to the VH/VL sequences having these CDRs. See also claim 23, part (4). Claim 7, part (3), corresponds to the HC/LC having these CDRs. Claim 8, part (3), corresponds to the HC/LC having these CDRs.
Claim 3, part (5), recites the 8F4 antibody CDRs. Claim 6, part (5), corresponds to the VH/VL sequences having these CDRs. See also claim 23, part (5). Claim 7, part (4), corresponds to the HC/LC having these CDRs. Claim 8, part (4), corresponds to the HC/LC having these CDRs.
Claim 3, part (6), recites the 17E2 antibody CDRs. Claim 6, part (6), corresponds to the VH/VL sequences having these CDRs. See also claim 23, part (6). Claim 7, part (5), corresponds to the HC/LC having these CDRs. Claim 8, part (5), corresponds to the HC/LC having these CDRs.
SEQ ID NOS: 39 and 67 comprise SEQ ID NO: 17 where X1 is N, X2 is Q, and X3 is K. SEQ ID NOS: 71 and 75 comprise SEQ ID NO: 17 where X1 is A, X2 is E, and X3 is Q. SEQ ID NOS: 73 and 77 comprise SEQ ID NO: 17 where X1 is A, X2 is K, and X3 is K. See claim 3, part (3); claim 22; and claim 24.
SEQ ID NO: 40 comprises SEQ ID NO: 30 where X4 is M and SEQ ID NO: 79 comprises SEQ ID NO: 30 where X4 is L. See claim 3, parts (2)-(5); claim 22; and claim 24.
See at least Tables 1-4.
The sequences corresponding to the sequences for antibodies 7D1, 3C6, 31C8, 26A1, 8F4, and 17E2 are free of the prior art. The CDRs recited in claim 3 must be retained by dependent claim 6 even in view of the at least 80% identity limitations. Otherwise, the dependent claim would not be properly dependent.
Claim Objections
Claim 7 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 8. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 7 and 8 are directed to antibodies having the same heavy and light chain sequences. They are of the same scope.
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.
Claims 3-4, 9-12, 16, 18, and 22 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.
The end of claim 3 has been amended to recite “wherein the amino acid sequence of SEQ ID NO: 17 is AIDPETGDTVYX₁X₂KFX₃G, where (i) X₁ = N, X₂ = Q, and X₃ = K; (ii) X₁ = A, X₂ = E, and X₃ = Q; or (iii) X₁ = A, X₂ = K, X₃ = K; and/or wherein the amino acid sequence of SEQ ID NO: 30 is QX4SNLAS, where X₄ = M or L.”
This is confusing. Claim 3, part (3), must define both SEQ ID NO: 17 and SEQ ID NO: 30. As such, the “or” embodiment leaves one or the other undefined or not clearly defined. Claim 3, parts (2) and (4)-(5) recite SEQ ID NO: 30 but not SEQ ID NO: 17. As such, the “and” embodiment is confusing for these parts.
Claim 22 is in reciting SEQ ID NO: 17 and/or SEQ ID NO: 30 where parts (i), (ii), and (iii) define both SEQ ID NO: 17 and SEQ ID NO: 30. That is, parts (i)-(iii) are directed to the “and” embodiment where X1, X2, X3, and X4 are defined and cannot be directed to the “or” embodiment. This is confusing. It appears that the limitations in this claim can only be in reference to claim 3, part (3). None of the other parts of claim 3 have both the HCDR2 of SEQ ID NO: 17 and the LCDR2 of SEQ ID NO: 30.
Claim 8 is allowable.
Claims 6-7 and 23-24 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.
Conclusion
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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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