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 .
Applicant’s amendments, filed 6/12/2026, is acknowledged.
Claims 2, 3, 5-15, 17-22, and 24-33 are cancelled.
Claims 1, 4, 16, 23, and 34-48 are currently pending and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/12/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner in its entirety.
In view of the amendments and remarks filed on 12/04/2025, the following rejections remain.
An interview was conducted on 8/20/2025 where a Terminal Disclaimer for Patent No. 12,195,555 was requested to overcome a double patenting rejection, however Applicant requested to proceed with prosecution instead.
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, 23, 34, and 36 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,195,555 (Pat ‘555, in Office Action mailed 3/13/2026), as evidenced by Connelley et al. (J Immunol. 2014 Apr 15;192(8):3868-80. doi: 10.4049/jimmunol.1302464). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
Claim 1 has been amended to recite that the BCMA antibody comprises a second arm that binds to the surface of an immune cell selected from a T-cell, a B-cell, a neutrophil, a monocyte, or a macrophage.
Pat ‘555 claims antigen binding domains comprising a VH and a VL (i.e., “an antibody or antigen binding fragment thereof”) with binding specificity to BCMA (claim 1), wherein the anti-BCMA antibody comprises the VH of SEQ ID NO: 49 and the VL of SEQ ID NO: 55 (claim 2).
SEQ ID NO: 49 is 100% identical to instant SEQ ID NO: 16:
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSNFGMHWVRQAPGRGLEWVAVIWSDETNRYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSNFGMHWVRQAPGRGLEWVAVIWSDETNRYY 60
Qy 61 ADSVKGRFTVSRDNVKSTVYLQMNSLISEDTAVYYCARDQQYCSSDSCFTWFDPWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTVSRDNVKSTVYLQMNSLISEDTAVYYCARDQQYCSSDSCFTWFDPWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
SEQ ID NO: 55 is 100% identical to instant SEQ ID NO: 24 (i.e., the limitations of instant claims 1, 4, and 34):
Qy 1 QTVVTQEPSLTVSPGGTVTLTCASSTGTVTPSNYANWVQQKPGQAFRGLIGDNNSRPPGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QTVVTQEPSLTVSPGGTVTLTCASSTGTVTPSNYANWVQQKPGQAFRGLIGDNNSRPPGT 60
Qy 61 PARFSASLLGGKAALTLSGVQPEDEAEYYCALWFGNQWVFGGGTKLTVL 109
|||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PARFSASLLGGKAALTLSGVQPEDEAEYYCALWFGNQWVFGGGTKLTVL 109
Regarding the claimed limitations of “comprises a second arm that binds to the surface of an immune cell selected from a T-cell, a B-cell, a neutrophil, a monocyte, or a macrophage” in instant claim 1, Pat ‘555 claims multispecific antibodies binding BCMA and NKp46 (claim 1). Connelley et al. is provided as an evidentiary reference to demonstrate that NKp46 is expressed on T-cells (Abstract): “…we demonstrate the existence of a population of NKp46+CD3+ cells resident in normal bovine PBMCs that includes cells of both the αß TCR+ and γδ TCR+ lineages…”, meeting the claim limitations.
Regarding instant claim 23, Pat ‘555 claims pharmaceutical compositions comprising the antibodies (claim 17).
Regarding instant claim 36, Pat ‘555 claims the antibodies further comprising Fc regions comprising full length heavy chains (claims 5 and 11).
Applicant’s arguments, filed 6/12/2026, have been fully considered, but have been found to be not convincing. Applicant argues that the cited reference does not claim the invention of the newly amended instant claims, however this has been found to be not convincing for the reasons discussed supra.
The invention encompassed by Pat ‘555, as evidenced by Connelley et al., anticipates the instantly claimed invention.
Claims 1, 4, 16, 23, and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,195,555 (Pat ‘555, supra) in view of Moutel et al. (BMC Biotechnol. 2009 Feb 26;9:14. doi: 10.1186/1472-6750-9-14, in Office Action mailed on 3/13/2026), as evidenced by Connelley et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘555 in view of Moutel et al., as evidenced by Connelley et al. for the same reasons discussed in the Office Action mailed on 3/13/2026.
Applicant’s arguments, filed 6/12/2026, have been fully considered, but have been found to be not convincing. Applicant argues that the cited reference does not claim the invention of the newly amended instant claims, however this has been found to be not convincing for the reasons discussed supra.
Claims 1, 4, 16, 23, and 34-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,195,555 (Pat ‘555, supra) in view of Schlothauer et al. (Protein Eng Des Sel. 2016 Oct;29(10):457-466. doi: 10.1093/protein/gzw040, in Office Action mailed on 3/13/2026), as evidenced by Connelley et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘555 in view of Schlothauer et al., as evidenced by Connelley et al. for the same reasons discussed in the Office Action mailed on 3/13/2026.
Applicant’s arguments, filed 6/12/2026, have been fully considered, but have been found to be not convincing. Applicant argues that the cited reference does not claim the invention of the newly amended instant claims, however this has been found to be not convincing for the reasons discussed supra.
Claims 1, 4, 23, 34, 36, 39-41, and 43-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,195,555 (Pat ‘555, in Office Action mailed 3/13/2026), in view of Seckinger et al. (Cancer Cell. 2017 Mar 13;31(3):396-410. doi: 10.1016/j.ccell.2017.02.002), as evidenced by Connelley et al. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention claimed by Pat ‘555 as evidenced by Connelley et al. is discussed supra. Pat ‘555 does not claim bispecific antibodies comprising a BCMA binding arm and a CD3 binding arm (i.e., the limitations of instant claims 39 and 40).
Seckinger et al., in the same field of endeavor, teaches bispecific anti-BCMA/anti-CD3 antibodies for the treatment of multiple myeloma (Abstract). Seckinger et al. teaches that the bispecific antibody engages T-cells to target multiple myeloma cells, leading to targeted killing of the cells (Fig. 2, 5). Seckinger et al. teaches (Discussion): “…EM801 emerges as an attractive non-cross resistant compound with high potential for use as a single agent, in combination, or in long-term maintenance treatment in multiple myeloma.”
It would have been obvious to one with ordinary skill in the art to have modified the invention claimed by Pat ‘555 in view of Seckinger al. to generate anti-BCMA/anti-CD3 bispecific antibodies using the anti-BCMA antibody of Pat ‘555 (i.e., the limitations of instant claims 39, 40, 41, and 44) with a reasonable expectation of success, as Seckinger et al. teaches such BCMA antibodies can be used in the bispecific format. One would have been motivated to make this change to generate a bispecific antibody to treat multiple myeloma.
Regarding instant claims 45-47, Seckinger et al. teaches the antibody is a full-length human IgG1 antibody (Results): “EM801 is constructed as an asymmetric two-arm IgG1-based human antibody…”, meeting the claim limitations
Applicants arguments are rendered moot in light of this new rejection.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘555 in view of Seckinger et al., as evidenced by Connelley et al., especially in absence of evidence to the contrary.
Claim 42 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,195,555 (Pat ‘555, supra) in view of Seckinger et al. (supra), as evidenced by Connelley et al. (supra), as applied to claims 1, 4, 23, 34, 36, 39-41, and 43-47 above, and further in view of Moutel et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al., is discussed supra. The combined references do not claim a chimeric antibody (i.e., the limitations of instant claim 42).
Moutel et al., in the same field of endeavor, teaches fusion of scFv antibody fragments to each of human, mouse, and rabbit IgG Fc regions (Abstract): “[t]his series enables the fusion of single chain Fv antibodies with human, mouse or rabbit Fc so that a given antibody is no longer restricted to a particular species…”
Moutel et al. teaches motivation to fuse these different Fc regions to a scFv (pg. 5): “[b]y fusing scFv to Fc domains, not only are we endowing recombinant antibodies with the same power as natural antibodies for classical immunological methods, but we also generate new and unique tools… Here, since we developed a series of vectors that allow not only fusion of scFv to human Fc but also to mouse or rabbit IgGs in a single sub-cloning step (see Figure 1), there no longer exists a species barrier in co-immunolabeling applications.”
It would have been obvious to one of ordinary skill in the art to have modified the invention of Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al. further in view of Moutel et al. to make an anti-BCMA bispecific antibody fused to each of a human, mouse, and rabbit antibody Fc region with a reasonable expectation of success, as Moutel et al. teaches methods of doing so. One would have been motivated to make this change for the purposes of generating anti-BCMA antibodies with a rabbit, mouse, or human Fc to use in co-immunolabeling applications to remove the species barrier.
Fusing the anti-BCMA antibody of Pat ‘555 to a mouse or rabbit Fc region would yield a chimeric antibody (i.e., the limitations of instant claim 42).
Applicants arguments are rendered moot in light of this new rejection.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al., and further in view of Moutel et al.
Claim 48 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,195,555 (Pat ‘555, supra) in view of Seckinger et al. (supra), as evidenced by Schlothauer et al. (supra), as applied to claims 1, 4, 23, 34, 36, 39-41, and 43-47 above, and further in view of Schlothauer et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al., is discussed supra. The combined references do not claim IgG1/IgG4 Fc regions (i.e., the limitations of instant claim 48).
Schlothauer et al., in the same field of endeavor, teaches generation of recombinant human IgG1 and IgG4 antibodies that do not bind to Fcγ receptors (Abstract): “[w]e describe here two new, engineered hIgG Fc domains, hIgG1-P329G LALA and hIgG4-P329G SPLE, with completely abolished FcγR and C1q interactions…”
Schlothauer et al. teaches that reducing binding to Fcγ receptors reduces unwanted side effects when the antibody is used in clinical applications (Introduction): “[a]brogation of Fc/FcγR and complement protein C1q interactions can be desired to prevent unwanted side effects such as infusion reactions and cell as well as tissue damage introduced by FcγR-mediated immune effector functions.”
It would have been obvious to one with ordinary skill in the art to have modified the invention of Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al. further in view of Schlothauer et al. to have made human IgG1 or IgG4 versions of the anti-BCMA antibody of Pat ‘555 (i.e., the limitations of instant claim 48) with reduced effector functions, as Schlothauer et al. teaches these Fc regions to be used in antibodies. One would have been motivated to make this change for the purposes of making anti-BCMA antibodies with reduced effector functions to reduce unwanted side effects in therapeutic applications of the antibody.
Applicants arguments are rendered moot in light of this new rejection.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al., and further in view of Schlothauer et al.
Claims 1, 4, 23, 34, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25, 27, 29, 31, 32, and 36-50 of copending Application No. 18/960,830 (App ‘830, in Office Action mailed 3/13/2026), as evidenced by Connelley et al. (J Immunol. 2014 Apr 15;192(8):3868-80. doi: 10.4049/jimmunol.1302464). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
Claim 1 has been amended to recite that the BCMA antibody comprises a second arm that binds to the surface of an immune cell selected from a T-cell, a B-cell, a neutrophil, a monocyte, or a macrophage.
App ‘830 claims nucleic acids encoding, and methods of making, anti-BCMA binding proteins comprising a VH and a VL (i.e., “an antibody”, claim 24), wherein the VH has the amino acid sequence of SEQ ID NO: 49 and the VL has the amino acid sequence of SEQ ID NO: 55 (claim 37).
SEQ ID NO: 49 is 100% identical to instant SEQ ID NO: 24:
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSNFGMHWVRQAPGRGLEWVAVIWSDETNRYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSNFGMHWVRQAPGRGLEWVAVIWSDETNRYY 60
Qy 61 ADSVKGRFTVSRDNVKSTVYLQMNSLISEDTAVYYCARDQQYCSSDSCFTWFDPWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTVSRDNVKSTVYLQMNSLISEDTAVYYCARDQQYCSSDSCFTWFDPWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
SEQ ID NO: 49 is 100% identical to instant SEQ ID NO: 24 (i.e., the limitations of instant claims 1, 4, and 34):
Qy 1 QTVVTQEPSLTVSPGGTVTLTCASSTGTVTPSNYANWVQQKPGQAFRGLIGDNNSRPPGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QTVVTQEPSLTVSPGGTVTLTCASSTGTVTPSNYANWVQQKPGQAFRGLIGDNNSRPPGT 60
Qy 61 PARFSASLLGGKAALTLSGVQPEDEAEYYCALWFGNQWVFGGGTKLTVL 109
|||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PARFSASLLGGKAALTLSGVQPEDEAEYYCALWFGNQWVFGGGTKLTVL 109
Regarding the claimed limitations of “comprises a second arm that binds to the surface of an immune cell selected from a T-cell, a B-cell, a neutrophil, a monocyte, or a macrophage” in instant claim 1, App ‘830 additionally claims nucleic acids comprising multi-specific antibodies comprising an anti-BCMA arm and an anti-NKp46 arm (claim 24). Connelley et al. is provided as an evidentiary reference to demonstrate that NKp46 is expressed on T-cells (Abstract): “…we demonstrate the existence of a population of NKp46+CD3+ cells resident in normal bovine PBMCs that includes cells of both the αß TCR+ and γδ TCR+ lineages…”, meeting the claim limitations.
Regarding instant claim 23, App ‘830 claims pharmaceutical compositions comprising the antibodies (claim 17).
Regarding claim 36, App ‘830 claims the antibodies further comprising Fc regions comprising full length heavy chains (claim 40).
It would have been obvious to one of ordinary skill in the art to have made the antibodies using the nucleic acids and methods of production claimed by App ‘830 with a reasonable expectation of success, as App ‘830 claims such methods. One would have been motivated to do so to produce the claimed anti-BCMA Antibodies.
Applicant’s arguments, filed 6/12/2026, have been fully considered, but have been found to be not convincing. Applicant argues that the cited reference does not claim the invention of the newly amended instant claims, however this has been found to be not convincing for the reasons discussed supra.
The invention encompassed by the instant claims is a prima facie obvious variant of the instant claimed invention, as evidenced by Connelley et al. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 16, 23, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25, 27, 29, 31, 32, and 36-50 of copending Application No. 18/960,830 (App ‘830, supra) in view of Moutel et al. (supra), as evidenced by Connelley et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘830 in view of Moutel et al., as evidenced by Connelley et al. for the same reasons discussed in the Office Action mailed on 3/13/2026.
Applicant’s arguments, filed 6/12/2026, have been fully considered, but have been found to be not convincing. Applicant argues that the cited reference does not claim the invention of the newly amended instant claims, however this has been found to be not convincing for the reasons discussed supra. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 16, 23, and 34-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25, 27, 29, 31, 32, and 36-50 of copending Application No. 18/960,830 (App ‘830, supra) in view of Schlothauer et al. (supra), as evidenced by Connelley et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘830 in view of Schlothauer et al., as evidenced by Connelley et al. for the same reasons discussed in the Office Action mailed on 3/13/2026.
Applicant’s arguments, filed 6/12/2026, have been fully considered, but have been found to be not convincing. Applicant argues that the cited reference does not claim the invention of the newly amended instant claims, however this has been found to be not convincing for the reasons discussed supra. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 23, 34, 36, 39-41, and 43-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25, 27, 29, 31, 32, and 36-50 of copending Application No. 18/960,830 (supra), in view of Seckinger et al. (supra), as evidenced by Connelley et al. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention claimed by App ‘830 as evidenced by Connelley et al. is discussed supra. App ‘830 does not claim bispecific antibodies comprising a BCMA binding arm and a CD3 binding arm (i.e., the limitations of instant claims 39 and 40).
Seckinger et al., in the same field of endeavor, teaches bispecific anti-BCMA/anti-CD3 antibodies for the treatment of multiple myeloma (Abstract). Seckinger et al. teaches that the bispecific antibody engages T-cells to target multiple myeloma cells, leading to targeted killing of the cells (Fig. 2, 5). Seckinger et al. teaches (Discussion): “…EM801 emerges as an attractive non-cross resistant compound with high potential for use as a single agent, in combination, or in long-term maintenance treatment in multiple myeloma.”
It would have been obvious to one with ordinary skill in the art to have modified the invention claimed by App ‘830 in view of Seckinger al. to generate anti-BCMA/anti-CD3 bispecific antibodies using the anti-BCMA antibody of App ‘830 (i.e., the limitations of instant claims 39, 40, 41, and 44) with a reasonable expectation of success, as Seckinger et al. teaches such BCMA antibodies can be used in the bispecific format. One would have been motivated to make this change to generate a bispecific antibody to treat multiple myeloma.
Regarding instant claims 45-47, Seckinger et al. teaches the antibody is a full-length human IgG1 antibody (Results): “EM801 is constructed as an asymmetric two-arm IgG1-based human antibody…”, meeting the claim limitations
Applicants arguments are rendered moot in light of this new rejection.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘830 in view of Seckinger et al., as evidenced by Connelley et al., especially in absence of evidence to the contrary. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 42 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25, 27, 29, 31, 32, and 36-50 of copending Application No. 18/960,830 (App ‘830, supra) in view of Seckinger et al. (supra), as evidenced by Connelley et al. (supra), as applied to claims 1, 4, 23, 34, 36, 39-41, and 43-47 above, and further in view of Moutel et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al., is discussed supra. The combined references do not claim a chimeric antibody (i.e., the limitations of instant claim 42).
Moutel et al., in the same field of endeavor, teaches fusion of scFv antibody fragments to each of human, mouse, and rabbit IgG Fc regions (Abstract): “[t]his series enables the fusion of single chain Fv antibodies with human, mouse or rabbit Fc so that a given antibody is no longer restricted to a particular species…”
Moutel et al. teaches motivation to fuse these different Fc regions to a scFv (pg. 5): “[b]y fusing scFv to Fc domains, not only are we endowing recombinant antibodies with the same power as natural antibodies for classical immunological methods, but we also generate new and unique tools… Here, since we developed a series of vectors that allow not only fusion of scFv to human Fc but also to mouse or rabbit IgGs in a single sub-cloning step (see Figure 1), there no longer exists a species barrier in co-immunolabeling applications.”
It would have been obvious to one of ordinary skill in the art to have modified the invention of Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al. further in view of Moutel et al. to make an anti-BCMA bispecific antibody fused to each of a human, mouse, and rabbit antibody Fc region with a reasonable expectation of success, as Moutel et al. teaches methods of doing so. One would have been motivated to make this change for the purposes of generating anti-BCMA antibodies with a rabbit, mouse, or human Fc to use in co-immunolabeling applications to remove the species barrier.
Fusing the anti-BCMA antibody of App ‘830 to a mouse or rabbit Fc region would yield a chimeric antibody (i.e., the limitations of instant claim 42).
Applicants arguments are rendered moot in light of this new rejection.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al., and further in view of Moutel et al. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 48 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25, 27, 29, 31, 32, and 36-50 of copending Application No. 18/960,830 (App ‘830, supra) in view of Seckinger et al. (supra), as evidenced by Schlothauer et al. (supra), as applied to claims 1, 4, 23, 34, 36, 39-41, and 43-47 above, and further in view of Schlothauer et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al., is discussed supra. The combined references do not claim IgG1/IgG4 Fc regions (i.e., the limitations of instant claim 48).
Schlothauer et al., in the same field of endeavor, teaches generation of recombinant human IgG1 and IgG4 antibodies that do not bind to Fcγ receptors (Abstract): “[w]e describe here two new, engineered hIgG Fc domains, hIgG1-P329G LALA and hIgG4-P329G SPLE, with completely abolished FcγR and C1q interactions…”
Schlothauer et al. teaches that reducing binding to Fcγ receptors reduces unwanted side effects when the antibody is used in clinical applications (Introduction): “[a]brogation of Fc/FcγR and complement protein C1q interactions can be desired to prevent unwanted side effects such as infusion reactions and cell as well as tissue damage introduced by FcγR-mediated immune effector functions.”
It would have been obvious to one with ordinary skill in the art to have modified the invention of Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al. further in view of Schlothauer et al. to have made human IgG1 or IgG4 versions of the anti-BCMA antibody of App ‘830 (i.e., the limitations of instant claim 48) with reduced effector functions, as Schlothauer et al. teaches these Fc regions to be used in antibodies. One would have been motivated to make this change for the purposes of making anti-BCMA antibodies with reduced effector functions to reduce unwanted side effects in therapeutic applications of the antibody.
Applicants arguments are rendered moot in light of this new rejection.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ’555 in view of Seckinger et al., as evidenced by Connelley et al., and further in view of Schlothauer et al. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEC JON PETERS whose telephone number is (703)756-5794. The examiner can normally be reached Monday-Friday 8:30am - 6:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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