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 .
Claims 1-4, 11, 12, 15, 16, and 29-45 are pending and currently under consideration.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). See Figures 20-25. Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
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 1-4, 11, 12, 15, 16, and 29-45 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 1-4, 11, 12, 15, 16, and 29-45 are rejected because claims 1 and 2 recite “SEQ ID NO:5”; however, the metes-and-bounds of the claims are unclear because the sequence of SEQ ID NO:5 is not defined by the specification, claims, or drawings.
However, it appears SEQ ID NO:5 may be the sequence “SAS” because the instant claims recite antibody constructs comprising CDRs of SEQ ID NO:1-6 or SEQ ID NO:7-12 and the instant specification discloses SEQ ID NO:1-6 define six CDRs of a parental antibody (of Figure 24 where CDR-L2, defined by IMGT numbering appears to be SAS) according to IMGT numbering and SEQ ID NO:5-12 define six CDRs of the same antibody according to the Kabat system (lines 24-29 on page 6, in particular).
In an effort to expedite prosecution, it is noted replacing SEQ ID NO:5 in claims 1 and 2 with the sequence SAS could obviate this rejection.
In an effort to expedite prosecution, the below rejections are interpreting “SEQ ID NO:5” to be the sequence SAS:
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 11, 12, 15, 16, and 29-45 are 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).
Claims 1-3, 11, 12, 15, 16, 29-35, 37, and 43-45 are 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).
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.
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 1-19 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.
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 1-4, 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.
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642