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 Claims
Examined Herein: 1-11
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in PRO 62/788,206 on 1/4/2019, PCT/US2020/012016 on 1/2/2020, and US 17/419,381 on 6/29/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/23/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings received on 9/17/2024 are accepted.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sherman (US 2009/0131529 A1, Published 5/21/2009), in view of Arnatt (US 2018/0289676 A1, Published 10/11/2018) and Sukumar (WO 2017/062394 A1, Published 4/8/2018).
With respect to claim 1, Sherman discloses a method for treating a human subject afflicted with breast cancer, comprising administering to the subject (i) a PARP inhibitor in conjunction with (ii) trastuzumab, wherein the amounts of the PARP inhibitor and trastuzumab, when administered in conjunction with one another, are therapeutically effective. [Sherman, 0094, 0184, 0200, 0339]
With respect to claims 2, 6, and 10, Sherman discloses that in some embodiments, the subject possesses a deleterious BRCA1/2 mutation. [Sherman, 0011, 0016, 0118, 0120, 0179, 0180]
With respect to claims 3, 7, and 11, Sherman discloses that in other embodiments, the subject does not possess a deleterious BRCA1/2 mutation. [Sherman, 0011, 0016, 0118, 0120, 0179, 0180, 0339, 0340]
Sherman further discloses that the method may further comprise administering radiation therapy or immunotherapy in combination with the PARP inhibitor and trastuzumab (the anti-tumor agent). [Sherman, 0143; see also 0145-0149, 0151, 0156]
Sherman does not specify that the PARP inhibitor is olaparib, niraparib, rucaparib, or talazoparib or disclose that the trastuzumab is labeled with 225Ac or 212Pb.
However, with respect to claim 1, Arnatt discloses a method for treating a human subject afflicted with breast cancer, comprising administering to the subject (i) a PARP inhibitor, olaparib, niraparib (MK-4827), rucarib, or talazoparib (BMN-673) in conjunction with radiotherapy, wherein the amounts of the PARP inhibitor and radiotherapeutic, when administered in conjunction with one another, are therapeutically effective. [Arnatt, 0194, 0222, 0250-0251]
Arnatt discloses that radiotherapy may include using radiolabeled antibodies to deliver doses of radiation directly to the cancer site (radioimmunotherapy). These antibodies can be attached to radioactive substances (a process known as radiolabeling). Once in the body, the antibodies actively seek out the cancer cells, which are destroyed by the cell-killing (cytotoxic) action of the radiation. This approach can minimize the risk of radiation damage to healthy cells. [Arnatt, 0229] Arnatt further discloses that radiolabeled antibodies, such as trastuzumab conjugated to a radionuclide, may function as immunotherapeutics that target and destroy cancer cells. [Arnatt, 0235]
With respect to claims 2, 6, and 10, Arnatt further discloses that the subject possesses a deleterious BRCA1/2 mutation. [Arnatt, 0247-0250]
Furthermore, with respect to claims 1 and 8, Sukumar discloses a method for treating a human subject afflicted with breast cancer, comprising administering to the subject a radioimmunotherapeutic, 225Ac-trastuzumab, wherein the amount administered is therapeutically effective. [Sukumar, 0031, 0035, 0062]
With respect to claims 1 and 4, Sukumar further discloses that 225Ac-trastuzumab may alternatively be radiolabeled with 212Pb. [Sukumar, 0024, 0055-0059]
With respect to claim 9, Sukumar discloses that 225Ac-trastuzumab comprises trastuzumab that has been conjugated to p-SCN-Bn-DOTA and radiolabeled with 225Ac. [Sukumar, 0029, 0074]
With respect to claim 5, Sukumar discloses that 225Ac-trastuzumab comprises trastuzumab that has been conjugated to p-SCN-Bn-DOTA and radiolabeled with 225Ac. [Sukumar, 0029, 0074] Sukumar further discloses that 225Ac may alternatively be radiolabeled with 212Pb (thereby forming 212Pb-trastuzumab, which comprises trastuzumab that has been conjugated to p-SCN-Bn-DOTA and radiolabeled with 212Pb). [Sukumar, 0024, 0055-0059]
Modifying the method disclosed by Sherman by selecting olaparib, niraparib, rucarib, or talazoparib as the PARP inhibitor and by radiolabeling trastuzumab with 225Ac or 212Pb results in the method of claims 1-11.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Sherman by selecting olaparib, niraparib, rucarib, or talazoparib as the PARP inhibitor and have a reasonable expectation of success. Sherman discloses a method for treating a human subject afflicted with breast cancer, comprising administering to the subject a PARP inhibitor. Arnatt discloses a method for treating a human subject afflicted with breast cancer, comprising administering to the subject a PARP inhibitor including olaparib, niraparib, rucarib, or talazoparib. Accordingly, the combined teachings of Sherman and Arnatt reasonably suggest that olaparib, niraparib, rucarib, or talazoparib may be selected as the PARP inhibitor administered in the method for treating breast cancer disclosed by Sherman. One would have been motivated to do so because the selection of a known compound based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Therefore, the selection of olaparib, niraparib, rucarib, or talazoparib based on its suitability as a PARP inhibitor used for treating a human subject afflicted with breast cancer is prima facie obvious.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Sherman by radiolabeling trastuzumab with 225Ac (thereby forming 225Ac-trastuzumab) or 212Pb (thereby forming 212Pb-trastuzumab) and have a reasonable expectation of success. Sherman discloses a method for treating a human subject afflicted with breast cancer, comprising administering to the subject a PARP inhibitor in conjunction with trastuzumab. Sherman further discloses that the method may further comprise administering a radiotherapeutic or immunotherapeutic in combination with the PARP inhibitor. Arnatt discloses a method for treating a human subject afflicted with breast cancer, comprising administering to the subject a PARP inhibitor in conjunction with a radiotherapeutic (i.e., a radiolabeled antibody). Arnatt further discloses that a radiolabeled antibody, such as trastuzumab conjugated to a radionuclide, may also function as an immunothearapeutic. Sukumar discloses a method for treating a human subject afflicted with breast cancer, comprising administering to the subject a radioimmunotherapeutic, 225Ac-trastuzumab or 212Pb-trastuzumab. Accordingly, the combined teachings of Sherman, Arnatt, and Sukumar reasonably suggest that the radioimmunotherapeutic, 225Ac-trastuzumab or 212Pb-trastuzumab, may be administered in conjunction with the PARP inhibitor in the method for treating breast cancer disclosed by Sherman. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II). In the present case, Arnatt discloses that once radiolabeled antibodies are in the body, they actively seek out the cancer cells, which are destroyed by the cell-killing action of the radiation. This approach can minimize the risk of radiation damage to healthy cells. [Arnatt, 0229] Moreover, combining radiation therapy with PARP inhibitors would lead to the formation of double-strand breaks from the single-strand breaks generated by the radiotherapy in tumor tissue with BRCA1/BRCA2 mutations. This combination could therefore lead to a more powerful therapy with the same radiation dose or with a lower radiation dose. [Arnatt, 0250] Therefore, one would have been motivated by the expectation that radiolabeling trastuzumab with 225Ac or 212Pb would enable the method disclosed by Sherman to deliver a more powerful therapy, while minimizing the risk of radiation damage to healthy cells.
Conclusion
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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