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/Restrictions
Applicant’s election without traverse of Triple Negative Breast cancer and of the antibody comprising SEQ ID NOs: 8 and 9 in the reply filed on 06/15/2026 is acknowledged. Upon further consideration, the Election requirement is withdrawn and all claims will be examined. Claims 1-27 are pending and are examined.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-27 are rejected under 35 U.S.C. 103 as being unpatentable over Fessler et al. (Abstract #906, 2021, cited by Applicant) in view of Nair et al. (J. Basic and Clin. Pharmacy, 7, 27-31, 2016- cited by Applicant).
The claims are drawn to a method of treating triple negative breast cancer (TNBC), hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in a subject comprising administering to the subject a B7-H4-targeted antibody-drug conjugate by infusion at a dose of between about 7.0 mg/m2 to about 90 mg/m2,
wherein the B7-H4-targeted antibody-drug conjugate is a conjugate of Formula (I):
the antibody binds B7-H4 and comprises a variable heavy chain complementarity
determining region 1 (CDRH1) comprising the amino acid sequence GFIVSRNY (SEQ ID NO: 2), a variable heavy chain complementarity determining region 2 (CDRH2) comprising the amino acid sequence IYGSGRT (SEQ ID NO: 3), a variable heavy chain complementarity determining region 3 (CDRH3) comprising the amino acid sequence ARDADYGLDV (SEQ ID NO: 4), a variable light chain complementarity determining region 1 (CDRL1) comprising the amino acid sequence QSVSSSY (SEQ ID NO: 5), a variable light chain complementarity determining region 2 (CDRL2) comprising the amino acid sequence GAS (SEQ ID NO: 6), and a variable light chain complementarity determining region 3 (CDRL3) comprising the amino acid sequence QQYGSSPL YT (SEQ ID NO: 7); the drug in formula I is attached to a heavy chain of the antibody via a linker moiety at an asparagine residue at position 297 when numbered in accordance with EU numbering (Compound XMT-1660).
Fessler et al. discloses XMT-1660 comprising of an anti-B7-H4 antibody site-specifically conjugated to Dolasynthen, with a total of 6 Dolalock Auristatin F-HPA
(AF-HPA) anti-tubulin payloads per antibody (DAR-6) and its preclinical profile. The drug is used for treating Triple Negative Breast cancer model in mice. The anti-tumor compound XMT-1660 is administrated as a single IV dose (mAb/AF-HBA) of 4.7/0.15 mg/kg (converted to 14.1 mg/m2 according to calculation algorithm presented in Nair et al. Table 1, Km(mouse)=3) in MX-1xenografts (Triple Negative Breast Cancer Models, mice) (Figure 5);
The anti-tumor compound XMT-1660 is administrated as a single IV dose of 4.7/0.15 mg/kg (converted to 14.1 mg/m2 according to calculation algorithm presented in Nair et al. Table 1, Km(mouse)=3) in HBCx-24 xenografts (Triple Negative Breast Cancer Models, mice) (Figure 6)
The anti-tumor compound XMT-1660 administrated as a single IV dose of 16.2/0.18 mg/kg (converted to 16.2 mg/m2 according to calculation algorithm presented in D2 Table 1, Km(mouse)=3) in HBCx-19 xenografts (ER+/HER2- POX Model, mice);
The subject-matter of the claims differs from Fessler et al in that the dosage
regimen involves follow-up doses every three weeks after the first dose and the
doses are administered via infusion while in the Fessler reference only the single IV dose was administered, and no particular IV administration method had been disclosed. The Fessler reference indicates suitable dosages for the administration of the compounds according to the application to cancer patients for achieving anti-cancer effects in vivo.
It should be noted that the provision of novel dosage regimens can only be seen
as involving an inventive step if such dosage regimens give rise to an unexpected technical effect. This technical effect must also be credibly demonstrated to be achieved over the whole scope of the subject-matter for which protection is sought.
It would be obvious to a person of ordinary skill in the art at the time that the invention was filed to provide an alternative dosage regimen starting from Fessler et al. with a reasonable expectation of success. This is because it is routine practice of the skilled person to develop a dosage regimen. Based on common general knowledge the skilled person is able to find appropriate dosages and try them in human patients.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
