MEDICAMENT FOR TREATMENT AND/OR PREVENTION OF CANCER

Application No. 18/573,750

• Filed: Dec 22, 2023
• Priority: Jun 23, 2021 — JP 2021-103818
  • Jun 22, 2022 — nonprovisional of PCTJP2022024812
• Examiner: JOHNSON, TIRONE DEREK
• Assignee: Toray Industries Inc.
• OA Round: 1 (Non-Final)

Office Action

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 .

Claim Status
The preliminary amendment filed 12/22/23 is acknowledged. Claims 3-16 are amended. Claims 1-19 are pending and under examination.

Claim Objections
Applicant is advised that should claim 17 be found allowable, claim 18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).

Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 14 recites that “wherein the antibody is a human antibody.” However, the specification does not reasonably convey that the inventors were in possession of an antibody that is a human antibody. The specification describes and exemplifies only humanized CAPRIN-1 antibodies and does not disclose any fully human CAPRIN-1 antibodies, representative species of human antibodies, or other identifying characteristics sufficient to demonstrate possession of the claimed antibody genus. Although humanized antibodies are described, a humanized antibody is structurally and compositionally distinct from a fully human antibody. Accordingly, the specification does not demonstrate possession of a human antibody.
Therefore, claim 14 is rejected under 35 U.S.C. 112(a) for lack of written description.

Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Okano et al., US Patent 9115200, in view of Ikeda et al. and Miao et al.
Claims 1-16 are drawn to a medicament, claims 17 and 18 are drawn to a drug efficacy increasing agent, and claim 19 is drawn to a method for treating and/or preventing cancer.
Okano et al. discloses a pharmaceutical composition for treating and/or preventing cancer comprising a monoclonal CAPRIN-1 antibody [see abstract] (instant claim 11) that comprises: the heavy chain variable region of SEQ ID NO: 43 and the light chain variable region of SEQ ID NO: 47 [see specification, col. 18, example “a”], which correspond to instant SEQ ID NOs: 39 and 43, respectively [see alignment below] (instant claims 1, 13, 17, 18, and 19), which themselves comprise the CDRs of instant SEQ ID NOs 36-38 and 40-42 (instant claim 12).

Instant SEQ ID NO:39 aligned to SEQ ID NO:43

AVTLDESGGGLQMSRGGLSLVCKASGFDFSSYQMNWIRQAPGKGLEFVAAINKFGNSTGH||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||AVTLDESGGGLQMSRGGLSLVCKASGFDFSSYQMNWIRQAPGKGLEFVAAINKFGNSTGHGAAVKGRVTISRDNGQSTVRLQLNNLRAEDTAIYFCTKHAYGYCGSGTWCAAGEIDAWGH||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||GAAVKGRVTISRDNGQSTVRLQLNNLRAEDTAIYFCTKHAYGYCGSGTWCAAGEIDAWGHGTEVIVSS||||||||GTEVIVSS

Instant SEQ ID NO:43 aligned to SEQ ID NO:47

QAASTQPSSVSANPGETVEITCSGGGSYSYGWFQQKSPGSAPVTVIYYNNKRPSDIPSRF
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
QAASTQPSSVSANPGETVEITCSGGGSYSYGWFQQKSPGSAPVTVIYYNNKRPSDIPSRF

SGSKSGSTGTLTITGVQADDEAVYYCGSGDSTDTAVFGAGTTLTVLGQ
||||||||||||||||||||||||||||||||||||||||||||||||
SGSKSGSTGTLTITGVQADDEAVYYCGSGDSTDTAVFGAGTTLTVLGQ

Okano et al. teaches that the antibody can be administered in combination with anti-tumor agents to produce a higher therapeutic effect [see specification, col. 15, lines 31-33], and specifically identifies the pyrimidine-based drug gemcitabine [see specification, col. 16, line 16] (instant claims 1, 5, and 17-19) and platinum compounds such as cisplatin, oxaliplatin, and carboplatin [see specification, col. 16, line 17] (instant claims 1, 7, and 17-19). Okano et al. teaches that the antibody exhibits antitumor effects against cancer cells expressing CAPRIN-1 on their cell surfaces [see specification, col. 29, lines 28-33], including breast cancer, gastric cancer and colorectal cancer [see specification, col. 39, lines 14-30] (instant claims 15 and 16). Further, Okano et al. discloses that the antibody binds to the surface of intact cancer cells, as demonstrated by flow cytometry and antibody-dependent cellular cytotoxicity, thereby showing that the antibody binds an extracellular region of CAPRIN-1 on the cell surface as these experiments necessarily require recognition of an extracellularly accessible portion of the protein [see specification, col. 39, lines 55-58] (instant claim 9). Okano et al. discloses that the antibody specifically reacts to a CAPRIN-1 polypeptide comprising SEQ ID NO: 2, which corresponds to instant SEQ ID NO: 2 [see claim 1] (instant claim 8), and a partial CAPRIN-1 peptide comprising SEQ ID NO: 37, which corresponds to instant SEQ ID NO: 31 [see claim 1] (instant claim 10). Okano et al. teaches that the antibody may be chimeric or humanized [see specification, col. 3, lines 55-57] (instant claim 14).
Okano et al. does not teach or suggest a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5, 6, 7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2].
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by Okano et al. to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while Okano et al. teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer, and also teaches that administering the antibody in combination with gemcitabine and oxaliplatin achieves a higher therapeutic effect. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both Okano et al. and Iketa et al. teach efficacy against the same disease type and Okano et al. expressly teaches combination of the antibody with additional chemotherapy components outlined by Ikeda et al. to produce a higher therapeutic effect.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-19 are rejected under 35 U.S.C. 103.

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 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9416192, in view of Ikeda et al., and Miao et al. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9416192 teaches a method of treating a CAPRIN-1 expressing cancer by administering a CAPRIN-1 antibody or fragment thereof that binds to CAPRIN-1 on the cell surface of the cancer (instant claims 1, 9, 15, and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9416192 does not teach or suggest a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9416192 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9416192 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9416192 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 9115200, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9115200 teaches a method of treating a cancer by administering a CAPRIN-1 antibody or fragment thereof (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9115200 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab, nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9115200 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer, which overexpresses CAPRIN-1, while 9115200 teaches that the CAPRIN-1 antibody is useful for treating cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9115200 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 9982059, in view of Ikeda et al., and Miao et al. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and useful for the treatment of cancer.
9982059 teaches a CAPRIN-1 antibody or fragment thereof that binds to CAPRIN-1 on the surface of cancer cells (instant claims 1, 9, 15, and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9982059 does not teach or suggest a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9982059 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9982059 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9982059 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 8911740, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
8911740 teaches a method of treating a CAPRIN-1 expressing cancer by administering a CAPRIN-1 antibody or fragment thereof and an antitumor agent (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
8911740 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 8911740 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 8911740 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 8911740 and Iketa et al. teach efficacy against the same disease type, 8911740 teaches that the antibody can be combined with an additional antitumor agent, and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8709418, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
8709418 teaches a method of treating a CAPRIN-1 expressing cancer by administering a CAPRIN-1 antibody or fragment thereof (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
8709418 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 8709418 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 8709418 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 8709418 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 8937160, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
8937160 teaches a method of treating a CAPRIN-1 expressing cancer by administering a CAPRIN-1 antibody or fragment thereof and an antitumor agent (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
8937160 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 8937160 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 8937160 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 8937160 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 8828398, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
8828398 teaches a method of treating a CAPRIN-1 expressing cancer by administering a CAPRIN-1 antibody or fragment thereof and an additional anticancer agent (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
8828398 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 8828398 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 8828398 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 8828398 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 9409993, in view of Ikeda et al., and Miao et al. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9409993 teaches a method of treating a CAPRIN-1 expressing pancreatic cancer by administering a CAPRIN-1 antibody or fragment thereof that binds CAPRIN-1 expressed on the cell surface and an antitumor agent (instant claims 1, 9, 15, and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9409993 does not teach or suggest a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9409993 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9409993 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9409993 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 9181334, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9181334 teaches a method of treating a CAPRIN-1 expressing cancer by administering a CAPRIN-1 antibody or fragment thereof (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9181334 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9181334 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9181334 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9181334 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 11, and 16-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 9181348, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9181348 teaches a method of treating a CAPRIN-1 expressing cancer by administering a CAPRIN-1 antibody or fragment thereof conjugated with an antitumor agent (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9181348 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9181348 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9181348 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9181348 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18). Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 9180188, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9180188 teaches a method of treating a CAPRIN-1 expressing cancer by administering a CAPRIN-1 antibody or fragment thereof and an additional antitumor agent (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9180188 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9180188 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9180188 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9180188 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 9273130, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9273130 teaches a combination drug for the treatment of a CAPRIN-1 expressing cancer comprising a CAPRIN-1 antibody or fragment thereof and an anticancer agent (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9273130 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9273130 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9273130 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9273130 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 9573993, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9573993 teaches a combination drug for the treatment of a CAPRIN-1 expressing cancer comprising a CAPRIN-1 antibody or fragment thereof and an antitumor agent (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9573993 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9573993 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9573993 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9573993 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 9260513, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9260513 teaches a method of treating a CAPRIN-1 expressing cancer by administering a CAPRIN-1 antibody or fragment thereof (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9260513 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9260513 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9260513 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9260513 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 9266958, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9266958 teaches a method of treating a CAPRIN-1 expressing cancer by administering a CAPRIN-1 antibody or fragment thereof (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9266958 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9266958 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9266958 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9266958 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 9416193, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9416193 teaches a method of treating a CAPRIN-1 expressing liver cancer by administering a CAPRIN-1 antibody or fragment thereof conjugated to an antitumor agent (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9416193 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9416193 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9416193 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9416193 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 9428581, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9862774, herein “Okano-2”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9428581 teaches a method of treating a CAPRIN-1 expressing cancer by administering a CAPRIN-1 antibody or fragment thereof conjugated to an anticancer agent (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9428581 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-2 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9428581 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9428581 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9428581 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 9862774, in view of Ikeda et al., Miao et al., and Okano et al. (US Patent 9266958, herein “Okano-3”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medicament comprising a CAPRIN-1 antibody and its use in the treatment of cancer.
9862774 teaches a combination drug for the treatment of a CAPRIN-1 expressing cancer comprising a CAPRIN-1 antibody or fragment thereof and an antitumor agent (instant claims 1 and 17-19). Given that monoclonal and polyclonal antibodies are the two standard classes of antibody preparations, it would have been obvious and expected that the disclosed antibody would fall within one of those two categories (instant claim 11).
9862774 does not teach or suggest where the antibody binds, a medicament comprising a CAPRIN-1 antibody combined with an angiogenesis inhibitor such as bevacizumab nor administering such a composition to patients with a specific treatment history.
Ikeda et al. discloses treating recurrent and refractory ovarian cancer using a combination of gemcitabine, oxaliplatin, and bevacizumab (also known as B-GEMOX) [see abstract] (instant claims 1, 5-7, and 17-19). Ikeda et al. discloses that the treated patients had received prior chemotherapy of a platinum containing compound, and their recurrent tumors were judged as refractory [see p. 357, col. 2, par. 1] (instant claims 1-4 and 17-19). Miao et al. discloses that CAPRIN-1 is upregulated in ovarian cancer [see p. 464, col. 1, par. 2] (instant claim 16). Okano-3 discloses that CAPRIN-1 is expressed on the cell surface of cancer cells and is under study as a target of antibody drugs for cancer treatment [see Background of the Art] (instant claims 9 and 15).
It would have been obvious to modify the combination therapy taught by Ikeda et al. to include the CAPRIN-1 antibody disclosed by 9862774 to generate the claimed medicament (instant claim 1) and administer said medicament to a patient with a history of cancer treatment (instant claim 19). Ikeda et al. teaches that gemcitabine, oxaliplatin, and bevacizumab constitute an effective treatment regimen for recurrent and refractory ovarian cancer while 9862774 teaches that the CAPRIN-1 antibody is useful for treating cancers overexpressing CAPRIN-1, like ovarian cancer. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art [see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I)]. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success because both 9862774 and Iketa et al. teach efficacy against the same disease type and combination therapies comprising antibodies and other agents in was routine clinical practice. Additionally, it would have been obvious and expected that the antibody would bind to an extracellular portion of the CAPRIN-1 protein that is expressed on the cell surface as the art teaches that CAPRIN-1 is expressed on the cell surface and is a known target for antibody mediated treatment.
Regarding claims 17 and 18, in a combination therapy exhibiting additive or synergistic therapeutic effects, each agent contributes to the overall therapeutic efficacy. Accordingly, a person having ordinary skill in the art would not have understood any single component, or subset of components, to be uniquely identifiable as the “drug efficacy increasing agent.” Designating the components as such merely reflects alternative characterizations of the same combination therapy (instant claims 17 and 18).
Therefore, claims 1-7, 9, 11, and 15-19 are rejected on the ground of nonstatutory double patenting.

Conclusion
No claims are allowed.

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/TIRONE D. JOHNSON/Examiner, Art Unit 1675

/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675

Prosecution Timeline

• Dec 22, 2023: Application Filed
• Aug 19, 2026: Non-Final Rejection mailed — §103, §112, §DOUBLEPATENT (current)