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 .
The Amendments and Remarks filed 4/28/26 in response to the Office Action of 10/30/25 are acknowledged and have been entered.
Claims 1-4, 11, 12, 15, 16, and 29-45 are pending.
Claims 1-2 have been amended by Applicant.
Claims 1-4, 11, 12, 15, 16, and 29-45 are currently under examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Objections Withdrawn
Objections to nucleotide and/or amino acid sequence disclosures are withdrawn.
Rejections Withdrawn
Rejection of claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn.
Rejections Maintained
Double Patenting
Claims 1-4, 11, 12, 15, 16, and 29-45 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12049500 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both the patent claims and the instant claims are drawn to anti-Nectin-4 antibodies of the same amino acid sequences, nucleic acids encoding the sequences, and host cells comprising vectors comprising said nucleic acids. Instant claims 43-45 differ from the patent claims in that instant claims 43-45 recite administering antibodies of the instant claims (same as antibodies of the patient claims) to patients having a recited disorder; however, it would have been obvious to administer the antibodies of the patent claims to a patient with a recited disorder because patent claim 6 recites the antibodies in combination with a carrier or excipient “suitable for use in medicine” and the patent discloses the antibodies of the patent claims are to be used in a medicine by administering the antibodies to patients with recited disorders (lines 8-24 of column 14, in particular).
Request for Reconsideration and Withdrawal
In the Reply of 4/28/26, Applicant submitted a terminal disclaimer and requests reconsideration and withdrawal of this rejection.
The amendments to the claims, the submission of the terminal disclaimer, and request for reconsideration and withdrawal of this rejection have been carefully considered, but are not deemed persuasive. The rejection is maintained for reasons of record. The submitted terminal disclaimer is disapproved because the terminal disclaimer identifies a party who is not applicant. The applicant cited on the terminal disclaimer must be cited exactly as it is cited on the Application Data Sheet (ADS) and or filing receipt and also in its entirety. If more space for applicant section is required, please use smaller fonts or submit an attachment page to a resubmitted terminal disclaimer. Please correct and resubmit a terminal disclaimer. No new fee is required.
Claims 1-3, 11, 12, 15, 16, 29-35, 37, and 43-45 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12419964 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both the patent claims and the instant claims are drawn to bispecific/chimeric anti-Nectin-4 antibodies comprising the same amino acid sequences and methods of treating the same patients with the said antibodies (note: SEQ ID NO: 5 of the patent comprises instant SEQ ID NOs: 1-3 and 7-9; SEQ ID NO: 5 of the patent is 97.3% identical to instant SEQ ID NO:27; SEQ ID NO: 5 of the patent comprises instant SEQ ID NO:41; SEQ ID NO:6 of the patent comprise instant SEQ ID NOs:4, 6, 10-12, and “SAS”; SEQ ID NO:6 of the patent is 96.2% identical to instant SEQ ID NO:28; SEQ ID NO:6 of the patent comprises instant SEQ ID NO:56). While the patent claims do not recite the patent claim antibody is an IgG4, it is obvious that antibodies of the patent include IgG4 antibodies because lines 35-39 at column 14 of the patent discloses the claimed antibody can be any of any class - including IgG4. Further, while the patent claims do not recite polynucleotides encoding the patent antibodies or host cells comprising vectors expressing said polynucleotides, it would be obvious to generate host cells comprising vectors comprising polynucleotides encoding the recited antibodies because (i) it is routine and conventional in the art to generate antibodies by generating host cells comprising vectors comprising polynucleotides encoding the antibodies and (ii) the copending specification discloses antibodies of the patent claims are to be made by generating host cells comprising vectors comprising polynucleotides encoding the patented antibodies (column 16, in particular).
Request for Reconsideration and Withdrawal
In the Reply of 4/28/26, Applicant submitted a terminal disclaimer and requests reconsideration and withdrawal of this rejection.
The amendments to the claims, the submission of the terminal disclaimer, and request for reconsideration and withdrawal of this rejection have been carefully considered, but are not deemed persuasive. The rejection is maintained for reasons of record. The submitted terminal disclaimer is disapproved because the terminal disclaimer identifies a party who is not applicant. The applicant cited on the terminal disclaimer must be cited exactly as it is cited on the Application Data Sheet (ADS) and or filing receipt and also in its entirety. If more space for applicant section is required, please use smaller fonts or submit an attachment page to a resubmitted terminal disclaimer. Please correct and resubmit a terminal disclaimer. No new fee is required.
Claims 1-4, 11, 12, 15, 16, and 29-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 11, 20, and 24-34 of copending Application No. 18/551282 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the copending claims are directed to the same antibodies that bind Nectin-4 and methods of administering said antibodies to the same subject. Note the SEQ ID NOs of the copending claims and those of the instant claims are the same. Further, note antibodies with VH and VL domains recited by the instant claims are obvious in view of the copending claims because the copending specification discloses said VH and VL domains as antibody domains comprising CDRs recited by the copending claims. Further, while the copending claims do not recite polynucleotides encoding the copending antibodies or host cells comprising vectors expressing said polynucleotides, it would be obvious to generate host cells comprising vectors comprising polynucleotides encoding the recited antibodies because (i) it is routine and conventional in the art to generate antibodies by generating host cells comprising vectors comprising polynucleotides encoding the antibodies and (ii) the copending specification discloses antibodies of the copending claims are to be made by generating host cells comprising vectors comprising polynucleotides encoding the patented antibodies (lines 12-23 on page 37, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Request
In the Reply of 4/28/26, Applicant requests this rejection be held in abeyance.
The amendments to the claims and the request found in the Reply of 4/28/26 have been carefully considered, but are not deemed persuasive. The Office does not hold rejections in abeyance. The rejection is maintained for reasons of record.
Claims 1-4, 11, 12, 15, 16, and 29-45 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/552056 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the copending claims are directed to the same antibodies that bind Nectin-4 and methods of administering said antibodies to the same subject. Note the SEQ ID NOs of the copending claims and those of the instant claims are the same. Further, note antibodies with VH and VL domains recited by the instant claims are obvious in view of the copending claims because the copending specification discloses said VH and VL domains as antibody domains comprising CDRs recited by the copending claims. Further, while the copending claims do not recite polynucleotides encoding the copending antibodies or host cells comprising vectors expressing said polynucleotides, it would be obvious to generate host cells comprising vectors comprising polynucleotides encoding the recited antibodies because (i) it is routine and conventional in the art to generate antibodies by generating host cells comprising vectors comprising polynucleotides encoding the antibodies and (ii) the copending specification discloses antibodies of the copending claims are to be made by generating host cells comprising vectors comprising polynucleotides encoding the patented antibodies (lines 11-20 on page 41, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Request
In the Reply of 4/28/26, Applicant requests this rejection be held in abeyance.
The amendments to the claims and the request found in the Reply of 4/28/26 have been carefully considered, but are not deemed persuasive. The Office does not hold rejections in abeyance. The rejection is maintained for reasons of record.
Claims 1-4, 11, 12, 15, 16, and 29-45 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 14-16, and 20-23 of copending Application No. 18/997648 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the copending claims are directed to the same antibodies that bind Nectin-4, polynucleotides encoding said antibodies, and host cells comprising vectors comprising said polynucleotides. Note the SEQ ID NOs of the copending claims and those of the instant claims are the same. Further, note antibodies with VH and VL domains recited by the instant claims are obvious in view of the copending claims because the copending specification discloses said VH and VL domains as antibody domains comprising CDRs recited by the copending claims. Further, while the copending claims do not recite methods of administering pharmaceutical compositions comprising copending antibodies to patients recited by the instant claims, it would be obvious to administer pharmaceutical compositions comprising antibodies of the copending claims with a carrier to patients of the instant claims because the copending specification discloses pharmaceutical compositions comprising antibodies of the copending claims with a carrier are to be administered to patients of the instant claims (page 15, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Request
In the Reply of 4/28/26, Applicant requests this rejection be held in abeyance.
The amendments to the claims and the request found in the Reply of 4/28/26 have been carefully considered, but are not deemed persuasive. The Office does not hold rejections in abeyance. The rejection is maintained for reasons of record.
Conclusion
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.
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
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