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 .
Election/Restriction
The response filed on 1/29/26 to the restriction requirement of 11/12/25 has been received. Applicant has elected an anti-CD3 construct comprising SEQ ID NOs: 10-17. Because Applicant did not distinctly and specifically point out any errors in the restriction requirement, the election has been treated as an election without traverse (MPEP 818.03(a)).
Claims 73-90 are pending and are currently under consideration.
The following species has been rejoined: anti-CD3 constructs comprising SEQ ID NOs: 2-4 and 6-8.
Information Disclosure Statement
The information disclosure statements filed 1/29/26 and 1/17/25 contain many citations that fail to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the citations lack dates. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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 78 and 87-90 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.
Claim 78 recites “A method of making the anti-CD3 scFv comprising….” There is insufficient antecedent basis for “the anti-CD3 scFv” in the claim.
Claims 87-90 are rejected because claims 87-88 both recite “…encoding the common light chain according to claim 85.” There is insufficient antecedent basis for “the common light chain according to claim 85” in the claims.
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 73-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11673972 B2. Patent SEQ ID NO:18 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 73-77 are not patentably distinct from patent claims 1-7 because patent claims 1-7 are drawn to anti-CD3 scFv constructs, nucleic acids encoding said constructs, expression vectors comprising said nucleic acids, and host cells comprising said expression vectors that are species of instant claims 73-77. Instant claim 78 is not patentably distinct from patent claims 1 and 7 because the anti-CD3 scFv of patent claim 1 is disclosed as being made by culturing the host cell of patent claim 7 and recovering the ani-CD3 scFv (lines 34-46 of column 17, in particular). The heterodimeric antibody structures comprising anti-CD3 scFv constructs of instant claims 79-80 and 85-86, the nucleic acids, expression vectors, and host cells of instant claims 81-83 and 87-89, and the methods of making the structures of instant claims 84 and 90 are not patentably distinct from patent claims 1-7 because the patent discloses the anti-CD3 scFv binding domains of the patent claims are to be generated in such heterodimeric structures (see Bottle-opener structure of patent Figure 1A and central-scFv structure of patent Figure 1B, in particular).
Claims 73-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 17-21 of U.S. Patent No. 10227410 B2. Patent SEQ ID NO:14 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 73-77 are not patentably distinct from patent claims 1-7 because patent claims 1-7 are drawn anti-CD3 scFv constructs, nucleic acids encoding said constructs, expression vectors comprising said nucleic acids, and host cells comprising said expression vectors that are species of instant claims 73-77. Although instant claims 73-78 and 85-90 are not identical to patent claims, they are not patentably distinct from each other because patent claims are directed to species of instant claims 73-78 and 85-90. Further, the heterodimeric antibody structures comprising anti-CD3 scFv constructs of instant claims 79-80, the nucleic acids, expression vectors, and host cells of instant claims 81-83, and the methods of making the structures of instant claim 84 are not patentably distinct from patent claims 1, 5, and 17-21 because the patent discloses heterodimeric antibodies of the patent claims are to be generated in the Central-scFv structure of patent Figure 1B.
Claims 73-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10259887 B2. Patent SEQ ID NO:14 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to species of the instant claims.
Claims 73-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-15 of U.S. Patent No. 10526417 B2. Patent SEQ ID NO:14 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 73-78 and 85-90 are not patentably distinct from patent claims 1-10 and 12-15 because patent claims 1-10 and 12-15 are drawn to species of instant claims 73-78 and 85-90. Further, the heterodimeric antibody structures comprising anti-CD3 scFv constructs of instant claims 79-80, the nucleic acids, expression vectors, and host cells of instant claims 81-83, and the methods of making the structures of instant claim 84 are not patentably distinct from patent claims 1-10 and 12-15 because the patent discloses heterodimeric antibodies of the patent claims are to be generated in the Central-scFv structure of patent Figure 1B.
Claims 73-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 14 and 20-23 of U.S. Patent No. 10982006 B2. Patent SEQ ID NO:89 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:85 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to species of the instant claims.
Claims 73-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 11-13 of U.S. Patent No. 11225528 B2. Patent SEQ ID NO:14 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to species of the instant claims.
Claims 73-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, and 8-13 of U.S. Patent No. 11352442 B2. Patent SEQ ID NO:14 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 73-78 and 85-90 are not patentably distinct from patent claims 1-10 and 12-15 because patent claims 1-10 and 12-15 are drawn to species of instant claims 73-78 and 85-90. Further, the heterodimeric antibody structures comprising anti-CD3 scFv constructs of instant claims 79-80, the nucleic acids, expression vectors, and host cells of instant claims 81-83, and the methods of making the structures of instant claim 84 are not patentably distinct from patent claims 1-10 and 12-15 because the patent discloses heterodimeric antibodies of the patent claims are to be generated in the Central-scFv structure of patent Figure 1B.
Claims 73-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6-8 of U.S. Patent No. 11919956 B2. SEQ ID NO:161 of the patent comprises instant SEQ ID NOs:10-13 and SEQ ID NO:162 of the patent comprises instant SEQ ID NOs:14-17. Although the claims at issue are not identical, they are not patentably distinct from each other. Patent claims 1, 4, and 6-8 are directed to species of instant claims 73-77, 79-83, and 85-89. Instant claims 78, 84, and 90 are not patentably distinct from patent claim 8 because patented heterodimeric constructs are disclosed as being made by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs (paragraph spanning columns 27-28, in particular). Further, it is conventional and routine in the art to generate heterodimeric antibody constructs by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs.
Claims 73, 75-79, 81-85, and 87-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12398207 B2. SEQ ID NO:98 of the patent comprises instant SEQ ID NOs: 2-4 and 6-8. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 73 and 85 are not patentably distinct from patent claim 1 because patent claim 1 is drawn to a species of the instant claims. Further, the heterodimeric antibody structure comprising anti-CD3 scFv constructs of instant claim 79 are not patentably distinct from patent claim 1 because the patent discloses heterodimeric antibodies of the patent claim are to be generated in the Central-scFv structure of patent Figure 36. Instant claims 75-78, 81-84, and 87-90 are not patentably distinct from patent claim 1 because patented heterodimeric constructs are disclosed as being made by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs (paragraph spanning columns 38-39, in particular). Further, it is conventional and routine in the art to generate heterodimeric antibody constructs by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs.
Claims 73, 75-79, 81-85, and 87-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No.11530274. SEQ ID NO:173 of the patent comprises instant SEQ ID NOs:6-8. SEQ ID NO:169 of the patent comprises instant SEQ ID NOs: 2-4. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claim 73 is not patentably distinct from patent claim 6 because the bispecific antibody of patent claim 6 is a species of instant claim 73. The heterodimeric antibody structures comprising anti-CD3 scFv constructs of instant claims 79 and 85 are not patentably distinct from patent claim 6 because the patent discloses the bispecific constructs of the patent claims are to be generated in such heterodimeric structures (see Bottle-opener structure and central-scFv structure of patent Figure 18, in particular). Instant claims 75-78, 81-84, and 87-90 are not patentably distinct from patent claim 6 because the anti-CD3 scFv bispecifc constructs of patent claim 6 are disclosed as being made by culturing the host cells with expression vectors encoding said constructs and recovering the constructs (paragraph spanning columns 62-63, in particular). Further, it is conventional and routine in the art to generate heterodimeric antibody constructs by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs.
Claims 73 and 75-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11053316 B2. Patent SEQ ID NO:398 comprises instant SEQ ID NOs:6-8. Patent SEQ ID NO:397 comprises instant SEQ ID NOs:2-4. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent nucleic acid constructs, vectors, cells, and method of making are species of instant claims 75-78. Claim 73 is not patentably distinct from patent claim 6 because the method of claim 6 makes the product of instant claim 73.
Claims 73 and 75-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 of U.S. Patent No. 10968276 B2. Patent SEQ ID NO:398 comprises instant SEQ ID NOs:6-8. Patent SEQ ID NO:397 comprises instant SEQ ID NOs:2-4. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claim 73 is not patentably distinct from patent claims 2-3 because the patent claims are species of the instant claim. Instant claims 75-78 are not patentably distinct from patent claims 2-3 because the anti-CD3 scFv constructs of patent claims 2-3 are disclosed as being made by culturing the host cells with expression vectors encoding said constructs and recovering the constructs (first full paragraph of column 37, in particular). Further, it is conventional and routine in the art to generate heterodimeric antibody constructs by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs.
Claims 73 and 75-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 of U.S. Patent No. 10131710 B2. Patent SEQ ID NO:398 comprises instant SEQ ID NOs:6-8. Patent SEQ ID NO:397 comprises instant SEQ ID NOs:2-4. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claim 73 is not patentably distinct from patent claims 2-3 because the patent claims are species of the instant claim. Instant claims 75-78 are not patentably distinct from patent claims 2-3 because the anti-CD3 scFv constructs of patent claims 2-3 are disclosed as being made by culturing the host cells with expression vectors encoding said constructs and recovering the constructs (first full paragraph of column 44, in particular). Further, it is conventional and routine in the art to generate heterodimeric antibody constructs by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs.
Claims 73, 75-78, 85, and 87-90 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No.9701759 B2. Patent SEQ ID NO:398 comprises instant SEQ ID NOs:6-8. Patent SEQ ID NO:397 comprises instant SEQ ID NOs:2-4. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 73 and 85 are not patentably distinct from patent claims 1-2 because the patent claims are species of the instant claims. Instant claims 75-78 and 87-90 are not patentably distinct from patent claims 2-3 because the anti-CD3 scFv constructs of patent claims 1-2 are disclosed as being made by culturing the host cells with expression vectors encoding said constructs and recovering the constructs (first full paragraph of column 4, in particular). Further, it is conventional and routine in the art to generate heterodimeric antibody constructs by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs.
Claims 73, 75-78, 85, and 87-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10738133 B2. Patent SEQ ID NO:398 comprises instant SEQ ID NOs:6-8. Patent SEQ ID NO:397 comprises instant SEQ ID NOs:2-4. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to species of the instant claims.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642