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
Claims 2-3, 13 and 15-16 have been cancelled.
Claims 18-26 are newly added.
Claims 1, 4-12, 14 and 17-26 are currently pending.
Claims 1, 4-12, 14 and 17-26 are being examined in this application.
Priority
This application is filed under 35 U.S.C 371 of PCT/JP2021/009795 (filed on 03/11/2021), which claims priority to foreign applications JAPAN 2020-043018 (filed on 3/12/2020).
Information Disclosure Statement
All IDS filed have been considered. See the attached PTO 1449 forms.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01.
Claim Objection(s) / Rejection(s) Withdrawn
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 11/28/2025) that are not repeated and/or maintained in the instant Office action are withdrawn.
New / Maintained Claim Objection(s) / Rejection(s)
Claim Rejections - 35 USC § 112
112(b) Rejection
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the amino acid sequence" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. The claim recites multiple sequences. It is not clear to which specific amino acid sequence the phrase is referring.
Claim 8 recites the limitation "the amino acid sequence" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. The claim recites multiple sequences. It is not clear to which specific amino acid sequence the phrase is referring.
112(a) Rejection(s)
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.
Written Description Rejection
Claims 6, 8, 20 and 22 are 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.
The instant claims recite antibody or fragments thereof that has immunological activity with the CAPRIN-1 protein of various sequences that can share 80% or more identities with different SEQ ID NOs as recited in claims 6, 8, 20 and 22.
To satisfy the written description requirement, applicants may convey reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
Applicants may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. See, e.g., Vas-Cath, 935 F.2d at 1565, 19 USPQ2d at 1118.
The written description requirement of 35 U.SC. 112 exists independently of enablement requirement, and the requirement applies whether or not the case involves questions of priority. The requirement applies to all inventions and includes chemical inventions. The fact that the patent is directed to method entailing use of compounds, rather than to compounds per se, does not remove patentee’s obligation to provide a description of the compound sufficient to distinguish infringing methods from non-infringing methods. See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ 2d 1886, 1890-93 (Fed. Cir. 2004).
With regard to the description requirement, applicants’ attention is invited to consider the decision of the Court of Appeals for the Federal Circuit, which holds that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it form other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)].
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species or by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d at 1568, 43 USPQ2d at 1406.
Each of claims 6, 8, 20 and 22 is drawn to a genus of amino acid sequences. Each claim recites “… an amino acid sequence having 80% or more sequence identity with” a list of various SEQ ID NOs. Neither the instant specification nor the claims have demonstrated common structure and/or function for the claimed genus of amino acid sequences that would have the same function as the CAPRIN-1 protein or that can be bound by the various anti-CAPRIN-1 antibodies. In addition, no representative numbers of species for each claimed genus of sequence are provided to show possession of the claimed genus of proteins or fragments thereof that can be bound by the various anti-CAPRIN-1 antibodies.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. (see MPEP 2163 II). In this case, the instant application did not provide the core sequences that would provide the CAPRIN-1 protein function or that can be bound by the various anti-CAPRIN-1 antibodies. The only examples are the sequences with the 100% matching sequences to the SEQ ID NOs that are the full CAPRIN-1 protien or fragments thereof. The instant specification has not provided any examples where proteins that share 40% or more identify with the CAPRIN-1 protein (or fragments thereof) would still have the same binding affinity and function.
Therefore, applicants are not in possession of the entire claimed genus of antibody sequences.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Ido
Claim(s) 1, 4-12, 14, 17 and 20-26 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously).
The instant claim 1 recites various embodiment of “A medicament for treatment of cancer, comprising an antibody or a fragment thereof specifically binding to a CAPRIN-1 protein and fluorouracil, levofolinate (1-leucovorin) and irinotecan and/or oxaliplatin together or separately in combination, wherein the cancer is cancer expressing CAPRIN-1 protein on a cell membrane surface.”
The recitation of “…irinotecan and/or oxaliplatin … and together or separately in combination” is interpreted to mean any combination of the CAPRIN-1 antibody with any one of the FOLFOX/FOLFIRI drugs (i.e. 5-FU, levofolinate or oxaliplatin/irinotecan, or CAPRIN-1 antibody with any combinations of the FOLFOX/FOLFIRI drugs.
The instant claim 17 recites “A method for treating cancer, comprising administering an antibody or a fragment thereof having an immunological reactivity with CAPRIN-1 protein, and fluorouracil, levofolinate (1- leucovorin) and irinotecan and/or oxaliplatin together or separately to a subject.
The recitation of “…irinotecan and/or oxaliplatin … and together or separately…” is interpreted to mean any combination of the CAPRIN-1 antibody with any one of the FOLFOX/FOLFIRI drugs (i.e. 5-FU, levofolinate or oxaliplatin/irinotecan, or CAPRIN-1 antibody with any combinations of the FOLFOX/FOLFIRI drugs.
Ido et al., throughout the reference, teach medicament comprising CAPRIN-1 antibody and other anti-tumor drugs and method of using thereof for treating cancer (e.g. Abstract).
For claims 1 and 17, the reference teaches a method of treating/preventing cancer by administering CAPRIN-1 antibody and “one or more types of antitumor agents” (e.g. claims 1+). The reference also teaches the antitumor agent can be 5-FU and irinotecan (e.g. claim 4).
For claims 4-5, the reference’s teaching reads on the inherent property recitation of the claims.
For claims 6 and 20, the reference teaches sequence of SEQ ID NO: 2, which is the CAPRIN-1 protein amino acid sequence, and as demonstrated in the previous Office action that it aligns with the instant SEQ ID NO: 2.
For claims 7, 21 and 25, the reference teaches antibodies that bind to the extracellular domain of the CAPRIN-1 protein. (e.g. col.3, lines 20+; col.7, lines 10+; claim 1).
For claims 8 and 22, Ido teaches the antibody binds a portion of the CAPRIN-1 protein "consisting of a sequence of 7 or more continuous amino acid residues within the region of amino acid residdue Nos. (aa) 50-98" of SEQ ID NO: 2 (e.g. Col. 7, 12). Residues 50-98 of Ido SEQ ID NO: 2 comprise the entirety of instantly claimed SEQ ID NO: 34 as demonstrated in the previous Office action.
For claims 9 and 23, the reference teaches mono or polyclonal antibodies (e.g. col.3, ll. 51-53).
For claims 10-11, the reference teaches an antibody comprising VH and VL with SEQ ID NO: 103 and 107, respectively (e.g. col.19, ll 60+), which contains the same HC CDRs and LC CDRs of the instant SEQ ID NOs: 146-148, 149-150 and 223, part (I) of the instant claim 10, and matches the instant SEQ ID NOs:72 and 73, part (g) of the instant claim 11.
For Claims 12 and 24, the reference teaches various forms of antibodies include a single chain antibody (e.g. claim 7).
For claims 14 and 26, the reference teaches various cancers including colon cancer (e.g. col. 24, ll. 35+).
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.
Ido, Ido 2012 and Masi
Claims 1, 4-12, 14, 17-19, and 20-26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The instant claim 1 recites various embodiment of “A medicament for treatment of cancer, comprising an antibody or a fragment thereof specifically binding to a CAPRIN-1 protein and fluorouracil, levofolinate (1-leucovorin) and irinotecan and/or oxaliplatin together or separately in combination, wherein the cancer is cancer expressing CAPRIN-1 protein on a cell membrane surface.”
The recitation of “…irinotecan and/or oxaliplatin … and together or separately in combination” can be interpreted to mean either a combination of the CAPRIN-1 antibody with either the FOLFOX drug combination (i.e. 5-FU + Levofolinate + Oxaliplatin), or with the FOLFIRI drug combination (i.e. 5-FU, levofolinate and irinotecan).
The instant claim 17 recites “A method for treating cancer, comprising administering an antibody or a fragment thereof having an immunological reactivity with CAPRIN-1 protein, and fluorouracil, levofolinate (1- leucovorin) and irinotecan and/or oxaliplatin together or separately to a subject.
The recitation of “…irinotecan and/or oxaliplatin … and together or separately…” can be interpreted to mean either a combination of the CAPRIN-1 antibody with either the FOLFOX drug combination (i.e. 5-FU + Levofolinate + Oxaliplatin), or with the FOLFIRI drug combination (i.e. 5-FU, Levofolinate and Irinotecan).
Ido et al., throughout the reference, teach medicament comprising CAPRIN-1 antibody and other anti-tumor drugs and method of using thereof for treating cancer (e.g. Abstract).
The Ido reference teaches a method of treating/preventing cancer by administering CAPRIN-1 antibody and “one or more types of antitumor agents” (e.g. claims 1+). The reference also teaches the antitumor agent can be 5-FU and irinotecan (e.g. claim 4), which two drugs are part of the FOLFOX/FOLFIRI treatment.
The Ido reference does not explicitly teach medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
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.
‘418 Patent
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 8709418 (hereinafter referred to as ‘418 Patent) in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The ‘418 Patent claims the followings:
A pharmaceutical composition for the treatment of a CAPRIN-1-expressing cancer or preventing the recurrence of a CAPRIN-1-expressing cancer, comprising an antibody or a fragment thereof as an active ingredient that has immunological reactivity with a CAPRIN-1 protein, wherein the antibody comprises a heavy chain variable region comprising SEQ ID NOS: 39, 40, and 41 and a light chain variable region comprising SEQ ID NOS: 43, 44, and 45 or a fragment thereof having anti-tumor activity.
The pharmaceutical composition according to claim 1, wherein the cancer is breast cancer, brain tumor, leukemia, lymphoma, lung cancer, mastocytoma, renal cancer, uterine cervix cancer, esophageal cancer, gastric cancer, bladder cancer, or colorectal cancer.
3. The pharmaceutical composition according to claim 1, wherein the antibody is a human antibody, humanized antibody, chimeric antibody, single chain antibody, or bispecific antibody.
6. A pharmaceutical combination for treating cancer, comprising the pharmaceutical composition of claim 1 and a pharmaceutical composition containing an antitumor agent.
8. A method for the treatment of a CAPRIN-1-expressing cancer or preventing the recurrence of a CARRIN-1-expressing cancer in a subject with cancer, comprising administering a therapeutically effective amount of the pharmaceutical composition comprising the pharmaceutical combination of claim 6 to a subject in need thereof.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
.
‘398 Patent
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 8828398 (hereinafter referred to as ‘398 Patent), in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The ‘398 Patent claims the followings:
A method for treating a CAPRIN-1 expressing cancer and/or preventing the recurrence of a CAPRIN-1 expressing cancer, comprising administering to a subject an antibody or a fragment thereof which has immunological reactivity with a polypeptide that consists of the amino acid sequence of SEQ ID NO: 37, and has immunological reactivity with CAPRIN-1 polypeptide.
A method for treating a CAPRIN-1 expressing cancer and/or preventing the recurrence of a CAPRIN-1 expressing cancer, comprising administering to a subject a pharmaceutical combination comprising:
(i) an antibody or fragment thereof that has immunological reactivity with a polypeptide that consists of the amino acid sequence of SEQ ID NO:37, and that has immunological reactivity with CAPRIN-1 polypeptide; and
(ii) an antitumor agent.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
‘160 Patent
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 8937160 (hereinafter referred to as ‘160 Patent), in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The ‘160 Patent claims the followings:
1. A method for treating a CAPRIN-1-expressing cancer, comprising administering to a subject having said cancer a monoclonal antibody or an antigen-binding fragment thereof, wherein said monoclonal antibody or antigen-binding fragment thereof specifically binds a polypeptide consisting of the amino acid sequence of SEQ ID NO: 37.
2. A method for treating a CAPRIN-1-expressing cancer, comprising administering a pharmaceutical combination comprising:
i. a monoclonal antibody or an antigen-binding fragment thereof as an active ingredient that specifically binds a polypeptide consisting of the amino acid sequence of SEQ ID NO: 37; and
ii. a pharmaceutical composition containing an antitumor agent in combination to a subject having said cancer.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
‘740 Patent
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 8911740 (hereinafter referred to as ‘740 reference Patent) in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The reference Patent claims the followings:
1. A method for treating and/or preventing recurrence of a CAPRIN-1 expressing cancer, comprising administering to a subject an antibody or a fragment thereof having immunological reactivity with a polypeptide that consists of the amino acid sequence of SEQ ID NO: 37.
2. A method for treating and/or preventing recurrence of a CAPRIN-1 expressing cancer, comprising administering to a subject a pharmaceutical combination comprising an antitumor agent, and
an antibody or a fragment thereof as an active ingredient that has immunological reactivity with a partial polypeptide of CAPRIN-1, wherein CAPRIN-1 is any of the even-numbered sequences of SEQ ID NOS: 2 to 30, and wherein the partial polypeptide consists of the amino acid sequence of SEQ ID NO: 37, or
an antibody or a fragment thereof having immunological reactivity with a polypeptide that consists of the amino acid sequence of SEQ ID NO: 37.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
‘074 Patent
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9175074 (hereinafter referred to as ‘074 reference Patent) in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The reference Patent claims the followings:
6. A pharmaceutical combination for treatment of CAPRIN -1- expressing cancer, comprising a pharmaceutical composition according to claim 4 and a pharmaceutical composition comprising an antitumor agent.
15. A method for treating CAPRIN-1-expressing cancer, comprising administering an antibody or a fragment thereof according to claim 6.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
‘187 Patent
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9180187 (hereinafter referred to as ‘187 reference Patent) in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The reference Patent claims the followings:
1. A method for treating and/or preventing recurrence of a CAPRIN-1 expressing cancer, comprising:
administering a medicament to a subject suspected of having a cancer,
wherein the medicament comprises a combination of an antibody or a fragment thereof having immunological reactivity with a CAPRIN-1 protein, and one or two or more types of antitumor agents,
wherein the antibody or fragment and the antitumor agent or antitumor agents are combined together or separately,
wherein the antibody or fragment and the antitumor agent are not conjugated together,
wherein the cancer expresses the CAPRIN-1 protein on the cell surface of the cancer and the antibody or fragment binds specifically to the extracellular region of a CAPRIN-1 protein existing on the surface of a cancer cell.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
‘188 Patent
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9180188 (hereinafter referred to as ‘188 reference Patent) in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The reference Patent claims the followings:
4. A pharmaceutical composition for treatment of caprin-1-expressing cancer, comprising an antibody or a fragment thereof according to claim 1 as an active ingredient.
6. A pharmaceutical combination for treatment of caprin-1-expressing cancer, comprising a pharmaceutical composition according to claim 4 and a pharmaceutical composition comprising an antitumor agent.
15. A method for treating caprin-1-expressing cancer, comprising administering a pharmaceutical combination according to claim 6 to a test subject.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
‘334 Patent
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9181334 (hereinafter referred to as ‘334 reference Patent) in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The reference Patent claims the followings:
4. A pharmaceutical composition for treatment of caprin-1-expressing cancer, comprising the antibody or the fragment thereof according to claim 1 as an active ingredient.
5. The pharmaceutical composition according to claim 4, wherein the cancer is breast cancer, kidney cancer, pancreatic cancer, colorectal cancer, lung cancer, brain tumor, gastric cancer, uterine cervix cancer, ovary cancer, prostate cancer, urinary bladder cancer, esophageal cancer, leukemia, lymphoma, fibrosarcoma, mastocytoma, or melanoma.
6. A pharmaceutical combination for treatment of caprin-1-expressing cancer, comprising the pharmaceutical composition according to claim 4 and a pharmaceutical composition comprising an antitumor agent.
15. A method for treating caprin-1-expressing cancer, comprising administering the pharmaceutical combination according to claim 6, to a subject.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
‘348 Patent
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9181348 (hereinafter referred to as ‘348 reference Patent) in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The reference Patent claims the followings:
1. An antibody or a fragment thereof which has immunological reactivity with a CAPRIN-1 protein, the antibody or the fragment thereof comprising a heavy chain variable region comprising complementarity determining regions of SEQ ID NOs: 5, 6, and 7 and a light chain variable region comprising complementarity determining regions of SEQ ID NOs: 9, 10, and 11.
2. The antibody or the fragment thereof according to claim 1, wherein the antibody is a human antibody, a humanized antibody, a chimeric antibody, a single-chain antibody, or a multispecific antibody.
3. The antibody or the fragment thereof according to claim 1, wherein the antibody or the fragment thereof is conjugated with an antitumor agent.
15. A method for treating CAPRIN-1-expressing cancer, comprising administering an antibody or a fragment thereof according to claim 3 to a test subject.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
‘200 Patent
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9115200 (hereinafter referred to as ‘200 reference Patent) in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The reference Patent claims the followings:
11. A pharmaceutical combination for treating and/or inhibiting the recurrence of a cancer, comprising the pharmaceutical composition of claim 1, and a pharmaceutical composition containing an antitumor agent.
12. A method for treating and/or inhibiting the recurrence of a cancer in a subject, comprising administering to the subject the monoclonal antibody of claim 4 or an antigen binding fragment thereof or the pharmaceutical composition of claim 1.
13. A method for treating and/or inhibiting the recurrence of a cancer in a subject, comprising administering to the subject the pharmaceutical combination of claim 11.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
Other Patents
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Nos. 9273128; 9273130; 9409993; 9416193; 9428581; 9266958; 9260513; 9573993; 9862774; 1137401 in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The reference Patents claim various CAPRIN-1 antibodies in combination with an antitumor agent, and methods of treating cancer using such a combination. For sake of brevity, only one reference patent’s relevant claims are included below as examples.
13. A pharmaceutical composition for treatment of cancer, comprising the antibody or the fragment thereof according to claim 1 as an active ingredient, wherein the cancer is a CAPRIN-1 expressing cancer.
14. The pharmaceutical composition according to claim 13, wherein the cancer is breast cancer, kidney cancer, pancreatic cancer, colorectal cancer, lung cancer, brain tumor, gastric cancer, uterine cervix cancer, ovary cancer, prostate cancer, urinary bladder cancer, esophageal cancer, leukemia, lymphoma, fibrosarcoma, mastocytoma, or melanoma.
15. A pharmaceutical combination for treatment of cancer, comprising a pharmaceutical composition according to claim 13 and a pharmaceutical composition comprising an antitumor agent.
17. A method for treating cancer, comprising administering the antibody or the fragment thereof according to claim 1, wherein the cancer is a CAPRIN-1 expressing cancer.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
‘538 Application
Claims 1-14 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-13, 16-20 of copending Application No. 17/910,538 (hereinafter referred to as the ‘538 reference application) in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
(NOTE the reference application has been allowed but is yet to be issued. This rejection will be converted to non-provisional rejection once it is issued.)
The reference application claims
A medicament for treatment of cancer, comprising (i) an antibody or a fragment thereof having an immunological reactivity with CAPRIN-1 protein, (ii) ramucirumab, and (iii) paclitaxel, nab-paclitaxel, or a combination of paclitaxel and nab- paclitaxel, wherein the taxane-based drug is paclitaxel, docetaxel, and/or nab-paclitaxel. wherein the cancer is cancer expressing CAPRIN-1 protein on a cell membrane surface.
18. (Currently Amended) A method for treating and/or preventing cancer, comprising administering (ii an antibody or a fragment thereof having an immunological reactivity with CAPRIN-1 protein, (ii) ramucirumab, and (iii) paclitaxel, nab-paclitaxel, or a combination of paclitaxel and nab- paclitaxel, to a subject in need thereof, wherein the cancer is cancer expressing CAPRIN-1 protein on a cell membrane surface.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
‘078 Application
Claims 1-14 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18/292,078 (hereinafter referred to as the ‘078 reference application) in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The reference Application claims a medicament comprising the CAPRIN-1 antibody and another antitumor drug, and the method of using the medicament for treating cancer as recited in claims 1, 4, 14, for examples.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
This is a provisional nonstatutory double patenting rejection.
‘549 Applications
Claims 1-14 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 17910549 (hereinafter referred to as the ‘549 reference application) in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The reference Application claims a medicament comprising the CAPRIN-1 antibody and another antitumor drug, and the method of using the medicament for treating cancer as recited in claims 1, 2, 4, 18, for examples.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
This is a provisional nonstatutory double patenting rejection.
Other Applications
Claims 1-14 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18573750; 18573641; 18292094; 18292656; 19103152; 19103661; 19105394; 19105407; 19105447 in view of Ido et al (US9180187; Nov. 10, 2015; filed on Feb. 4, 2011 or earlier; cited previously), in view of Ido et al (CN102844048; 12/26/2012; hereinafter referred to as Ido 2012 (CN102844048; 12/26/2012; Machine Translation is relied upon for the below rejection), Masi et al (Lancet Oncology. Vol 11: 845-852; 2010), and if necessary Govindan et al (US20140170063; 6/19/2014).
The reference applications’ claim various CAPRIN-1 antibodies in combination with an antitumor agent, and methods of treating cancer using such a combination. For sake of brevity, only one reference application’s relevant claims are included below as examples.
The ‘750 reference Application, for example, claims a medicament comprising the CAPRIN-1 antibody and another antitumor drug, and the method of using the medicament for treating cancer as recited in claims 1 and 19, for examples.
The reference patent does not explicitly claim a medicament or treatment comprising either FOLFOX or FOLFIRI as recited in claims 1 and 17 as can be interpreted, the cancer patient populations of claims 18-19.
However, Ido 2012, throughout the reference, teaches combining CAPRIN-1 antibodies with other antitumor agents (combinations of agents) (e.g. Claims 1+). The reference teaches various antitumor agents including 5-FU, folinic acid (alternative name for Levofolinate), oxaliplatin, and irinotecan (See [0116]).
Further, Masi, throughout the reference teaches combination therapy with an antibody, Bevacizumab, and the FOLFOXIRI (or FOLFOX/FOLFIRI) (e.g. Abstract). The reference teaches increased efficacy with combined therapy with increase patient survival rate (e.g. p.850-851).
And if necessary, Govindan et al., throughout the publication, teaches combined therapy with an antibody and chemotherapy (e.g. Claims 1 and 21). The reference also teaches treatment can be for patients who have failed FOLFIRI or FOLFOX (e.g. Claims 26, 71). The reference teaches the advantages of using combined therapy for patients who are resistant to “standard anti-cancer therapies” (e.g. Abstract; [0003]; [0019]-[0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to make and use a combination anti-cancer therapy comprising the CAPRIN-1 antibody (or fragment thereof) and a known chemotherapy such as FOLFOX or FOLFIRI, because Ido and Ido 2012 both teach a combination of CAPRIN-1 antibody and chemical drugs that are either subset or full set of the known chemotherapy FOLFOX/FOLFIRI as taught by Masi. In addition, both Masi and Govindan teach the advantages of combination therapy with an antibody and other chemo agents that they offer higher efficacy and patient survival rates, and also offer alternative therapy for patients who are resistant to standard anticancer therapies. Thus, it would have been obvious to one of ordinary skill in the art to apply the known anti-cancer therapy by combining an antibody with FOLFOX/FOLFIRI therapy to improve the therapeutic efficacy and patient response.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Ido, Ido 2012, Masi and Govindan all teach combination therapies are known and carried out based on patient needs.
This is a provisional nonstatutory double patenting rejection.
Answer to Argument
Applicants’ arguments are based on the rejections set forth in the previous Office action. However, all new rejections are set forth above in the instant Office action.
Conclusion and Correspondence
No claims are allowed.
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/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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