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 .
Status of Application, Amendments and/or Claims
The amendment of 03 May 2024 has been entered in full. Claims 1-133 are cancelled. Claims 134-156 are added.
Claims 134-156 are under consideration in the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09 January 2025 and 02 August 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
1. The disclosure is objected to because of the following informalities:
1a. At page 5, [0019], the Brief Description of the Drawings does not refer to Figure 3A and 3B.
Appropriate correction is required.
Claim Objections
2. Claims 134 and 151-153 are objected to because of the following informalities:
2a. In claim 134, line 2, after the recitation of “antigen”, a hyphen should be inserted (i.e., “antigen-binding portion”) for consistency with the first recitation of the phrase in line 1.
2b. In claims 151-153, line 1, the term “CDRL2” should be amended to recite “CDRL3” (to match the recited SEQ ID NOs).
Appropriate correction is required.
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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3. Claims 134-156 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,220,535 in view of Holler et al. (Gene 136: 323-328, 1993), Martin, M.T. (US 2003/0100000), Richardson et al. (Genome Res 16: 550-556, 2006), and Villalobos et al. (BMC Bioinformatics 7: 285, 2006).
Claim 134 of the instant application recites a nucleic acid encoding a protein comprising an antigen-binding portion, wherein the antigen binding portion is an anti-B-Cell Maturation Antigen (BCMA) binding domain comprising:
a heavy chain complementarity determining region 1 (CDRH1) comprising any one of SEQ ID NOs: 1-3;
a heavy chain complementarity determining region 2 (CDRH2) comprising any one of SEQ ID NOs: 4-6;
a heavy chain complementarity determining region 3 (CDRH3) comprising any one of SEQ ID NOs: 7-9;
a light chain complementarity determining region 1 (CDRL1) comprising any one of SEQ ID NOs: 10-11;
a light chain complementarity determining region 2 (CDRL2) comprising any one of SEQ ID NOs: 12-15; and
a light chain complementarity determining region 3 (CDRL3) comprising any one of SEQ ID NOs: 16-18;
provided that the anti-BCMA binding domain does not comprise all six of the following:
a CDRH1 comprising SEQ ID NO: 1;
a CDRH2 comprising SEQ ID NO: 4;
a CDRH3 comprising SEQ ID NO: 7;
a CDRL1 comprising SEQ ID NO: 10;
a CDRL2 comprising SEQ ID NO: 12; and
a CDRL3 comprising SEQ ID NO: 16.
Meanwhile, claim 1 of the ‘535 patent recites, for example, a protein comprising an antigen-binding portion, wherein the antigen binding portion is an anti-B-Cell Maturation Antigen (BCMA) binding domain comprising:
a heavy chain complementarity determining region 1 (CDRH1) comprising any one of SEQ ID NOs: 1-3;
a heavy chain complementarity determining region 2 (CDRH2) comprising any one of SEQ ID NOs: 4-6;
a heavy chain complementarity determining region 3 (CDRH3) comprising any one of SEQ ID NOs: 7-9;
a light chain complementarity determining region 1 (CDRL1) comprising any one of SEQ ID NOs: 10-11;
a light chain complementarity determining region 2 (CDRL2) comprising any one of SEQ ID NOs: 12-15; and
a light chain complementarity determining region 3 (CDRL3) comprising any one of SEQ ID NOs: 16-18;
provided that the anti-BCMA binding domain does not comprise all six of the following:
a CDRH1 comprising SEQ ID NO: 1;
a CDRH2 comprising SEQ ID NO: 4;
a CDRH3 comprising SEQ ID NO: 7;
a CDRL1 comprising SEQ ID NO: 10;
a CDRL2 comprising SEQ ID NO: 12; and
a CDRL3 comprising SEQ ID NO: 16.
It is noted that the amino acid sequences of SEQ ID NOs: 1-18 recited in the claims of the ‘535 patent are 100% identical to the same respective sequences recited in the claims of the instant application.
The claims of the ‘535 patent do not recite a nucleic acid encoding the claimed protein.
Although the claims of the ‘535 patent are directed to a protein and the claims of the instant application are directed to nucleic acids encoding such, the nucleic acid sequences (including mRNA) that encode the patented protein can be determined and generated by conventional methodologies known to one of skill in the art in view of the methods taught by Holler et al. (see entirety) and Martin (page 2; Figures 1-2; pages 6-8). One skilled in the art can also use commercially available computer software to translate the amino acid sequences of the '535 patent to nucleic acid sequences (see Richardson et al. (entirety, Figure 1) and Villalobos et al. (entirety)).
Thus, it would have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the protein of the ‘535 patent claims by determining the nucleic acids encoding such and expressing/producing the protein, as taught by Holler et al., Martin, Richardson et al., and Villalobos et al. The person of ordinary skill in the art would have been motivated to make those modifications because the protein of the ‘535 patent is a chimeric antigen receptor (CAR) specific for BCMA and BCMA has been linked to a number of cancers, autoimmune disorders, allergic disorders, and infectious diseases (see ‘535 claims and column 1, lines 18-46). The person of ordinary skill in the art reasonably would have expected success because the generation and isolation of nucleic acids via “reverse translation”, as taught by Holler et al., Martin, Richardson et al., and Villalobos et al. was already being performed at the time the invention was made. There are a limited number of methods to do such and thus, the person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely not the product of innovation but of ordinary skill and common sense (see KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
4. Claims 134-156 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,934,337 in view of Holler et al. (Gene 136: 323-328, 1993), Martin, M.T. (US 2003/0100000), Richardson et al. (Genome Res 16: 550-556, 2006), and Villalobos et al. (BMC Bioinformatics 7: 285, 2006).
Claim 134 of the instant application recites a nucleic acid encoding a protein comprising an antigen-binding portion, wherein the antigen binding portion is an anti-B-Cell Maturation Antigen (BCMA) binding domain comprising:
a heavy chain complementarity determining region 1 (CDRH1) comprising any one of SEQ ID NOs: 1-3;
a heavy chain complementarity determining region 2 (CDRH2) comprising any one of SEQ ID NOs: 4-6;
a heavy chain complementarity determining region 3 (CDRH3) comprising any one of SEQ ID NOs: 7-9;
a light chain complementarity determining region 1 (CDRL1) comprising any one of SEQ ID NOs: 10-11;
a light chain complementarity determining region 2 (CDRL2) comprising any one of SEQ ID NOs: 12-15; and
a light chain complementarity determining region 3 (CDRL3) comprising any one of SEQ ID NOs: 16-18;
provided that the anti-BCMA binding domain does not comprise all six of the following:
a CDRH1 comprising SEQ ID NO: 1;
a CDRH2 comprising SEQ ID NO: 4;
a CDRH3 comprising SEQ ID NO: 7;
a CDRL1 comprising SEQ ID NO: 10;
a CDRL2 comprising SEQ ID NO: 12; and
a CDRL3 comprising SEQ ID NO: 16.
Meanwhile, claim 1 of the ‘337 patent recites, for example, a chimeric antigen receptor (CAR) comprising: (i) an anti-B-Cell Maturation Antigen (BCMA) binding domain; (ii) a transmembrane domain; and (iii) a cytoplasmic domain, wherein the anti-BCMA binding domain comprises:
a heavy chain complementarity determining region 1 (CDRH1) comprising any one of SEQ ID NOs: 1-3;
a heavy chain complementarity determining region 2 (CDRH2) comprising any one of SEQ ID NOs: 4-6;
a heavy chain complementarity determining region 3 (CDRH3) comprising any one of SEQ ID NOs: 7-9;
a light chain complementarity determining region 1 (CDRL1) comprising any one of SEQ ID NOs: 10-11;
a light chain complementarity determining region 2 (CDRL2) comprising any one of SEQ ID NOs: 12-15; and
a light chain complementarity determining region 3 (CDRL3) comprising any one of SEQ ID NOs: 16-18;
provided that the anti-BCMA binding domain does not comprise all six of the following:
a CDRH1 comprising SEQ ID NO: 1;
a CDRH2 comprising SEQ ID NO: 4;
a CDRH3 comprising SEQ ID NO: 7;
a CDRL1 comprising SEQ ID NO: 10;
a CDRL2 comprising SEQ ID NO: 12; and
a CDRL3 comprising SEQ ID NO: 16.
It is noted that the amino acid sequences of SEQ ID NOs: 1-18 recited in the claims of the ‘337 patent are 100% identical to the same respective sequences recited in the claims of the instant application.
The claims of the ‘337 patent do not recite a nucleic acid encoding the claimed protein.
Although the claims of the ‘337 patent are directed to a protein and the claims of the instant application are directed to nucleic acids encoding such, the nucleic acid sequences (including mRNA) that encode the patented protein can be determined and generated by conventional methodologies known to one of skill in the art in view of the methods taught by Holler et al. (see entirety) and Martin (page 2; Figures 1-2; pages 6-8). One skilled in the art can also use commercially available computer software to translate the amino acid sequences of the '337 patent to nucleic acid sequences (see Richardson et al. (entirety, Figure 1) and Villalobos et al. (entirety)).
Thus, it would have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the protein of the ‘337 patent claims by determining the nucleic acids encoding such and expressing/producing the protein, as taught by Holler et al., Martin, Richardson et al., and Villalobos et al. The person of ordinary skill in the art would have been motivated to make those modifications because the protein of the ‘337 patent is a chimeric antigen receptor (CAR) specific for BCMA and BCMA has been linked to a number of cancers, autoimmune disorders, allergic disorders, and infectious diseases (see ‘337 claims and column 1, lines 16-44). The person of ordinary skill in the art reasonably would have expected success because the generation and isolation of nucleic acids via “reverse translation”, as taught by Holler et al., Martin, Richardson et al., and Villalobos et al. was already being performed at the time the invention was made. There are a limited number of methods to do such and thus, the person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely not the product of innovation but of ordinary skill and common sense (see KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
Conclusion
No claims are allowable.
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BEB
Art Unit 1647
13 October 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
