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 .
Response to Amendment
Applicant’s remarks and amendments to the claims received 05/11/2026 have been acknowledged. Claims 1, 3-10, 12, 16-19, 21, 25, 26, and 30 have been amended. Claims 2 and 13 have been cancelled. Claim 31 is newly added. The claim amendments/cancellations overcome rejections made under 35 USC 112 (a), 35 USC 112(b) and 35 USC 112(d) previously set forth in the Non-Final Rejection mailed 02/05/2026.
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 1, 3-10, 12, 16-19, 21, 25, 26, and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-10, 12-17, 19-20, 23, 25, and 29-30 of copending Application No. 18277931 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims either anticipate or are obvious variants over the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The co-pending claims recite an anti-PD-L1 x CD47 bispecific antibody comprising a first single domain antibody (sdAb) that targets PD-L1 and a second sdAb that targets CD47, wherein the second sdAb comprises CDR1, CDR2, and CDR3 of SEQ ID NOs: 7, 8, and 9, respectively (co-pending claims 1 and 3). The amino acid sequences of SEQ ID NOs: 7, 8, and 9 respectively correspond to the amino acid sequences of SEQ ID NOs: 3, 4, and 5 recited in the instant claims. The anti-CD47 sdAb is defined by the amino acid sequence of SEQ ID NO: 6, corresponding to SEQ ID NO: 1 of the instant claims (co-pending claim 9). The anti-CD47 sdAb or antigen-binding fragment thereof includes the following VHH domain: (1) FR1 consisting of the amino acid sequence of SEQ ID NO: 17 (corresponding to SEQ ID NO: 11 of the instant claims); (2) FR2 consisting of the amino acid sequence of SEQ ID NO: 18 (corresponding to SEQ ID NO: 12 of the instant claims); (3) FR3 consisting of the amino acid sequence of SEQ ID NO: 19 (corresponding to SEQ ID NO: 13 of the instant claims); and FR4 consisting of the amino acid sequence of SEQ ID NO: 20 (corresponding to SEQ ID NO: 14 of the instant claims) (co-pending claim 6). The first and second antigen-binding moieties are fused to each other via a peptide linker (co-pending claim 10). The bispecific antibody comprises at least one or more amino acid substitutions, wherein the at least one or more amino acid substitutions are a) conservative substitutions or b) a substitution of an amino acid with a non-genetically encoded amino acid or a synthetic amino acid (co-pending claims 12-14). The bispecific antibody can also be conjugated to an immunomodulator, cytokine, cytotoxic agent, chemotherapeutic agent, diagnostic agent, antiviral agent, antimicrobial agent, or drug (co-pending claim 23). The bispecific antibody can be a heavy chain only antibody (HCab) wherein the first or second sdAb can be fused to an Fc fragment via a peptide linker (co-pending claim 15), wherein the bispecific antibody of this embodiment can comprise one or more amino acid substitutions (co-pending claim 20). The HCab is monomeric or multimeric (co-pending claim 16); and the Fc fragment is human IgG1, IgG2, IgG3, or IgG4 (co-pending claim 17). The HCab consists of an amino acid sequence of SEQ ID NO: 12 which fully comprises SEQ ID NO: 19 of the instant claims (co-pending claim 19). Further recited is a nucleic acid molecule encoding the bispecific antibody, an expression vector comprising the nucleic acid, and a host cell transformed with the expression vector (co-pending claim 25). Lastly recited is a method for preventing or treating cancer comprising administering the bispecific antibody to an individual (co-pending claim 29), wherein the cancer is selected from the group consisting of melanoma, lung cancer, liver cancer, glioblastoma, ovarian cancer, colorectal cancer, head and neck cancer, bladder cancer, renal cell cancer, stomach cancer, breast cancer, metastatic cancer, prostate cancer, pancreatic cancer, non- Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma, leukemia, lymphoma, myelodysplastic syndrome, acute lymphoblastic leukemia, acute myelogenous leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, solitary myeloma and aplastic anemia (co-pending claim 30).
Thus, the co-pending claims meet the limitations of instant claims 1, 3-10, 12, 16-19, 21, 25, 26, and 31.
Claim 30 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-10, 12-17, 19-20, 23, 25, and 29-30 of copending Application No. 18277931, as applied to claims 1-10, 12, 13, 16-19, 21, 25, and 26 above, in view of Sato et al (US20170369572A1), hereinafter Sato.
This is a provisional nonstatutory double patenting rejection.
The teachings of the co-pending claims have been discussed above and differ from the instantly claimed invention in that a method for detecting CD47 or determining the amount of CD47 in a sample is not specifically taught.
However, Sato discloses methods of detecting CD47 or determining the amount of CD47 in a sample comprising (a) contacting a biological sample from the patient with one or more anti-CD47 antibodies or antigen-binding fragments; (b) detecting binding of the antibody or antigen-binding fragment to CD47 to determine a CD47 protein level in the biological sample from the patient; and (c) comparing the CD47 protein level with a standard CD47 protein level (Section 5.4.1: Diagnostic Uses, Para. 0214-0228). For detection, the anti-CD47 antibody can be conjugated to a detectable substrate such as a fluorescent compound, an enzymatic substrate, a radioactive compound or a luminescent compound, or a second antibody which recognizes the first antibody can be conjugated to a detectable substrate) (Para. 0190). The term “antibody” encompasses bispecific antibodies (Para. 0049-0050). Thus, the methods of detecting CD47 or determining the amount of CD47 in a sample can be performed using a bispecific anti-CD47 antibody.
It would have been obvious to one of ordinary skill in the art to use the bispecific anti-PD-L1 x CD47 antibodies of the co-pending claims to detect CD47 or determine the amount of CD47 present in a biological sample from a subject. One of ordinary skill in the art would have been motivated to do so since anti-CD47 antibodies can be used in methods of detection and diagnosis as taught by Sato. Therefore, one of ordinary skill in the art would expect that the bispecific anti-PD-L1 x CD47 antibodies of the co-pending claims can be used to detect CD47 or determine the amount of CD47 present in a sample.
Claims 1, 3-10, 12, 16-19, 21, 25, 26, and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18951146 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims either anticipate or are obvious variants over the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The co-pending claims recite an anti-PD-L1 x CD47 bispecific antibody comprising a first humanized single domain antibody (sdAb) or antigen-binding fragment thereof that targets PD-L1 and a second humanized sdAb that targets CD47, wherein the second sdAb comprises the CDRs of SEQ ID NOs: 9, 10, and 11 (co-pending claims 1 and 3). The amino acid sequences of SEQ ID NOs: 9, 10, and 11 respectively correspond to the amino acid sequences of SEQ ID NOs: 3, 4, and 5 recited in the instant claims. The first and second antigen-binding moieties are fused to each other via a peptide linker (co-pending claim 10). The bispecific antibody can also be conjugated to an immunomodulator, cytokine, cytotoxic agent, chemotherapeutic agent, diagnostic agent, antiviral agent, antimicrobial agent, or drug (co-pending claim 17). The bispecific antibody can be a heavy chain only antibody (HCab) wherein the first or second sdAb can be fused to an Fc fragment via a peptide linker (co-pending claim 12), wherein the bispecific antibody of this embodiment can comprise one or more amino acid substitutions (co-pending claim 16). The HCab is monomeric or multimeric (co-pending claim 13); and the Fc fragment is human IgG1, IgG2, IgG3, or IgG4 (co-pending claim 14). Further recited is a nucleic acid molecule encoding the bispecific antibody, an expression vector comprising the nucleic acid, and a host cell transformed with the expression vector (co-pending claim 18). Lastly recited is a method for preventing or treating cancer comprising administering the bispecific antibody to an individual (co-pending claim 19), wherein the cancer is selected from the group consisting of melanoma, lung cancer, liver cancer, glioblastoma, ovarian cancer, colorectal cancer, head and neck cancer, bladder cancer, renal cell cancer, stomach cancer, breast cancer, metastatic cancer, prostate cancer, pancreatic cancer, non- Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma, leukemia, lymphoma, myelodysplastic syndrome, acute lymphoblastic leukemia, acute myelogenous leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, solitary myeloma and aplastic anemia (co-pending claim 20).
Thus, the co-pending claims meet the limitations of instant claims 1-2, 8-10, 16-19, 21, 25, and 26.
Claim 30 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18951146, as applied to claims 1, 3-10, 12, 16-19, 21, 25, 26, and 31 above, in view of Sato et al (US20170369572A1), hereinafter Sato.
This is a provisional nonstatutory double patenting rejection.
The teachings of the co-pending claims have been discussed above and differ from the instantly claimed invention in that a method for detecting CD47 or determining the amount of CD47 in a sample is not specifically taught.
However, Sato discloses methods of detecting CD47 or determining the amount of CD47 in a sample comprising (a) contacting a biological sample from the patient with one or more anti-CD47 antibodies or antigen-binding fragments; (b) detecting binding of the antibody or antigen-binding fragment to CD47 to determine a CD47 protein level in the biological sample from the patient; and (c) comparing the CD47 protein level with a standard CD47 protein level (Section 5.4.1: Diagnostic Uses, Para. 0214-0228). For detection, the anti-CD47 antibody can be conjugated to a detectable substrate such as a fluorescent compound, an enzymatic substrate, a radioactive compound or a luminescent compound, or a second antibody which recognizes the first antibody can be conjugated to a detectable substrate) (Para. 0190). The term “antibody” encompasses bispecific antibodies (Para. 0049-0050). Thus, the methods of detecting CD47 or determining the amount of CD47 in a sample can be performed using a bispecific anti-CD47 antibody.
It would have been obvious to one of ordinary skill in the art to use the bispecific anti-PD-L1 x CD47 antibodies of the co-pending claims to detect CD47 or determine the amount of CD47 present in a biological sample from a subject. One of ordinary skill in the art would have been motivated to do so since anti-CD47 antibodies can be used in methods of detection and diagnosis as taught by Sato. Therefore, one of ordinary skill in the art would expect that the bispecific anti-PD-L1 x CD47 antibodies of the co-pending claims can be used to detect CD47 or determine the amount of CD47 present in a sample.
Response to Arguments
Applicant' s arguments, see Remarks filed 05/05/2026, with respect to rejections made under 35 USC 112(a), 35 USC 112(b), and 35 USC 112(d), have been fully considered and are persuasive. The aforementioned rejections have been withdrawn.
With respect to the double patenting rejection over the claims of co-pending application 18/227,931, Applicant requests that the rejection be held in abeyance. Since no terminal disclaimers have been filed and no amendments have been made to the instant or co-pending claims such that they represent patentably distinct inventions, the double patenting rejection previously set forth is maintained.
Conclusion
No claims are allowable.
THIS ACTION IS MADE FINAL. 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.
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/LIA E TAYLOR/ Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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