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 .
DETAILED ACTION
Applicant’s election without traverse of Group II, claims 31-35, in the reply filed on 12/10/2025 is acknowledged.
Claims 23-35 are pending.
Claims 23-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/10/2025.
Claims 31-35 are under examination on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 31-35 have an effective filing date of 10/25/2017, corresponding to PRO 62/576,948.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/25/2023, 07/30/2024, and 12/10/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections
Nonstatutory 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.
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Claims 31-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7 of U.S. Patent No. 11,603,412 in view of Fasick et al. (WO 2006/004950, international publication date: 01/12/2006).
The instant claims are drawn to a radioisotope-labeled antibody that specifically binds CUB domain-containing protein 1 (CDCP1) ectodomain and comprises light chain CDRs 1-3 of SEQ ID NO:11, SEQ ID NO:13 and SEQ ID NO:20, respectively, and heavy chain CDRs 1-3 of SEQ ID NO:17, SEQ ID NO:18, and SEQ ID NO:19, respectively, wherein the radioisotope is a positron-emitter, such as 89Zr, wherein the antibody comprises a heavy chain variable domain (VH) and a light chain variable domain (VL), and the VH comprises the amino acid sequence having at least 95% (or 100%) sequence identity to SEQ ID NO:57, and the VL comprises an amino acid sequence having at least 95% (or 100%) sequence identity to SEQ ID NO:58.
The conflicting claims are drawn to an antibody that specifically binds a CUB domain-containing protein 1 (CDCP1) ectodomain, comprising light chain CDRs 1-3 of SEQ ID NO:11, SEQ ID NO:13 and SEQ ID NO:20, respectively, and heavy chain CDRs 1-3 of SEQ ID NO:17, SEQ ID NO:18, and SEQ ID NO:19, respectively, wherein the antibody comprises a heavy chain variable domain (VH) and a light chain variable domain (VL), and the VH comprises the amino acid sequence of SEQ ID NO:57, and the VL comprises the amino acid sequence of SEQ ID NO:58, and wherein the antibody further comprises a detectable label conjugated to the antibody or antibody fragment.
The primary difference between the instant and conflicting claims is that the instant claims require a CDCP1 antibody conjugated to a detectable label that is a radioisotope, such as 89Zr.
At p. 15, Fasick et al. teach that “In a specific embodiment of the invention, the chimeric 31.1 monoclonal antibodies maybe used for in vivo imaging of colon, breast, and ovarian cancer using different reporter molecules and methods of labeling known to those of ordinary skill in the art. Examples of the types of reporter molecules that can be used in the present invention include radioactive isotopes, bio luminescent and chemiluminescent molecules, paramagnetic isotopes, and compounds which can be imaged by positron emission tomography (PET)... Those of ordinary skill in the art will know of other suitable labels for binding to the antibodies used in the invention, or will be able to ascertain such, using routine experiments. Furthermore, the binding of these labels to the antibody can be done using standard techniques common to those of ordinary skill in the art. For in vivo diagnosis, radionuclides may be bound to the antibody either directly or indirectly by using an intermediary functional group… Examples of metallic ions which can be bound to the antibodies of the present invention are .sup.99Tc, .sup.1231, .sup.111In, .sup.1311, .sup.97Ru, .sup.67Cu, .sup.67Ga, .sup.1251, .sup.68Ga, .sup.72As, .sup.89Zr (emphasis added)…” Based upon the teachings of Fasick et al., one of ordinary skill in the art would appreciate that antibodies may be conjugated to a radioisotope, such as 89Zr, and said radioisotope-labeled antibodies may be used in tumor imaging using PET.
One of ordinary skill in the art would have been motivated to modify the conflicting claims to recite that the CDCP1 antibody is conjugated to a radioisotope, such as 89Zr, because the resultant radioisotope-labeled CDCP1 antibody could be used in tumor imaging using PET.
Therefore the instant claims are prima facie obvious over the conflicting claims in view of Fasick et al.
Claims 31-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 13-15 of copending Application No. 18/655,103 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims are drawn to a radioisotope-labeled antibody that specifically binds CUB domain-containing protein 1 (CDCP1) ectodomain and comprises light chain CDRs 1-3 of SEQ ID NO:11, SEQ ID NO:13 and SEQ ID NO:20, respectively, and heavy chain CDRs 1-3 of SEQ ID NO:17, SEQ ID NO:18, and SEQ ID NO:19, respectively, wherein the radioisotope is a positron-emitter, such as 89Zr, wherein the antibody comprises a heavy chain variable domain (VH) and a light chain variable domain (VL), and the VH comprises the amino acid sequence having at least 95% (or 100%) sequence identity to SEQ ID NO:57, and the VL comprises an amino acid sequence having at least 95% (or 100%) sequence identity to SEQ ID NO:58.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 31-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 13-15 of copending Application No. 18/655,081 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims are drawn to a radioisotope-labeled antibody that specifically binds CUB domain-containing protein 1 (CDCP1) ectodomain and comprises light chain CDRs 1-3 of SEQ ID NO:11, SEQ ID NO:13 and SEQ ID NO:20, respectively, and heavy chain CDRs 1-3 of SEQ ID NO:17, SEQ ID NO:18, and SEQ ID NO:19, respectively, wherein the radioisotope is a positron-emitter, such as 89Zr, wherein the antibody comprises a heavy chain variable domain (VH) and a light chain variable domain (VL), and the VH comprises the amino acid sequence having at least 95% (or 100%) sequence identity to SEQ ID NO:57, and the VL comprises an amino acid sequence having at least 95% (or 100%) sequence identity to SEQ ID NO:58.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 31-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 77, 90, and 93 of copending Application No. 18/359,562 in view of Fasick et al. (WO 2006/004950, international publication date: 01/12/2006).
The instant claims are drawn to a radioisotope-labeled antibody that specifically binds CUB domain-containing protein 1 (CDCP1) ectodomain and comprises light chain CDRs 1-3 of SEQ ID NO:11, SEQ ID NO:13 and SEQ ID NO:20, respectively and heavy chain CDRs 1-3 of SEQ ID NO:17, SEQ ID NO:18, and SEQ ID NO:19, respectively, wherein the radioisotope is a positron-emitter, such as 89Zr, wherein the antibody comprises a heavy chain variable domain (VH) and a light chain variable domain (VL), and the VH comprises the amino acid sequence having at least 95% (or 100%) sequence identity to SEQ ID NO:57, and the VL comprises an amino acid sequence having at least 95% (or 100%) sequence identity to SEQ ID NO:58.
The conflicting claims are drawn to an antibody that specifically binds a CUB domain-containing protein 1 (CDCP1) ectodomain, comprising a heavy chain variable domain (VH) and a light chain variable domain (VL), and the VH comprises the amino acid sequence of SEQ ID NO:59, which shares 100% homology with the instant SEQ ID NO:57, and the VL comprises the amino acid sequence of SEQ ID NO:60, which shares 100% homology with the instant SEQ ID NO:58.
The primary difference between the instant and conflicting claims is that the instant claims require a CDCP1 antibody conjugated to a detectable label that is a radioisotope, such as 89Zr.
At p. 15, Fasick et al. teach that “In a specific embodiment of the invention, the chimeric 31.1 monoclonal antibodies maybe used for in vivo imaging of colon, breast, and ovarian cancer using different reporter molecules and methods of labeling known to those of ordinary skill in the art. Examples of the types of reporter molecules that can be used in the present invention include radioactive isotopes, bio luminescent and chemiluminescent molecules, paramagnetic isotopes, and compounds which can be imaged by positron emission tomography (PET)... Those of ordinary skill in the art will know of other suitable labels for binding to the antibodies used in the invention, or will be able to ascertain such, using routine experiments. Furthermore, the binding of these labels to the antibody can be done using standard techniques common to those of ordinary skill in the art. For in vivo diagnosis, radionuclides may be bound to the antibody either directly or indirectly by using an intermediary functional group… Examples of metallic ions which can be bound to the antibodies of the present invention are .sup.99Tc, .sup.1231, .sup.111In, .sup.1311, .sup.97Ru, .sup.67Cu, .sup.67Ga, .sup.1251, .sup.68Ga, .sup.72As, .sup.89Zr (emphasis added)…” Based upon the teachings of Fasick et al., one of ordinary skill in the art would appreciate that antibodies may be conjugated to a radioisotope, such as 89Zr, and said radioisotope-labeled antibodies may be used in tumor imaging using PET.
One of ordinary skill in the art would have been motivated to modify the conflicting claims to recite that the CDCP1 antibody is conjugated to a radioisotope, such as 89Zr, because the resultant radioisotope-labeled CDCP1 antibody could be used in tumor imaging using PET.
Therefore the instant claims are prima facie obvious over the conflicting claims in view of Fasick et al.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON B MOSELEY II whose telephone number is (571)272-6221. The examiner can normally be reached on M-F, 9:00-6:00 EST.
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/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642