DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 4/15/25(2); 4/28/25; 5/8/25; 1/8/26 The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 67-78 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent Application No. 12171744 in view of Alpenic et al. Blood (2016) 128 (22) 899. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the instant are drawn to a method of treating a blood cancer in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of voruciclib or a pharmaceutically acceptable salt thereof, wherein: the blood cancer is selected from acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphocytic lymphoma (ALL), chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, intravascular large B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma, marginal zone B-cell lymphoma, extranodal marginal zone B-cell lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone B-cell lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma, and primary central nervous system lymphoma, and the subject is under treatment with a therapeutically effective amount of venetoclax or a pharmaceutically acceptable salt thereof.and the patented claims are to a method of treating a cancer such as acute lymphocytic lymphoma (ALL), diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, intravascular large B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma, marginal zone B-cell lymphoma, extranodal marginal zone B-cell lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone B-cell lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma, primary central nervous system lymphoma, and triple negative breast cancer (TNBC), the method comprising administering to a subject in need thereof a therapeutically effective amount of a CDK inhibitor represented by Formula such as formula Ib wherein the second drug is a proteosome inhibitor.
Although the instant claims fails to recite that the second drug is a proteosome inhibitor The instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that 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 form a third composition that is to be used for the very same purpose since the idea of combining them flows logically from their having been individually taught in the prior art. Aplenic teaches the use of bortezomib a proteosome inhibitor as a standard chemotherapeutic Applying the same logic, given the teaching of the prior art methods of using bortezomid and venetoclax individually for treating acute myeloid leukemia, it would have been obvious to use both compounds for the treatment of acute myeloid leukemia because the idea of doing so would have logically followed from their having been individually taught in the prior art to be useful as therapeutic agents.
Both sets of claims refer to the same composition and/or derivatives thereof for the treatment of blood cancer. The current application claims are obvious variation.
In view of the foregoing, the patented claims and the current application claims are obvious variations of each other.
Claims 67-68 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-10 of U.S. Patent 11,135198. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the instant are drawn to a pharmaceutical composition comprising a therapeutically effective amount of a CDK inhibitor represented by Formula Ib, wherein the CDK inhibitor or a pharmaceutically acceptable salt thereof is (+)-trans-2-(2-chloro-4-trifluoromethylphenyl)- 5,7-dihydroxy-8-(2-hydroxymethyl-1-methyl-pyrrolidin-3-yl)-chromen-4-one hydrochloride, further comprising a kit for treating blood cancer is selected from acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphocytic lymphoma (ALL), and chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, intravascular large B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma, marginal zone B-cell lymphomas, extranodal marginal zone B-cell lymphomas, nodal marginal zone B-cell lymphoma, splenic marginal zone B-cell lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma, and primary central nervous system lymphoma and the copending claims are to a method of treating a blood cancer comprising administering to a subject in need thereof a therapeutically effective amount of a CDK inhibitor represented by Formula 1b or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of venetoclax or a pharmaceutically acceptable salt thereof
Both sets of claims refer to the same composition and/or derivatives thereof for the treatment of blood cancer. The current application claims are obvious variation.
In view of the foregoing, the copending application claims and the current application claims are obvious variations of each other.
Claims 67-68 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-11 of U.S. Patent 12121508. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the instant are drawn to a pharmaceutical composition comprising a therapeutically effective amount of a CDK inhibitor represented by Formula Ib, wherein the CDK inhibitor or a pharmaceutically acceptable salt thereof is (+)-trans-2-(2-chloro-4-trifluoromethylphenyl)- 5,7-dihydroxy-8-(2-hydroxymethyl-1-methyl-pyrrolidin-3-yl)-chromen-4-one hydrochloride, further comprising a kit for treating blood cancer is selected from acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphocytic lymphoma (ALL), and chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, intravascular large B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma, marginal zone B-cell lymphomas, extranodal marginal zone B-cell lymphomas, nodal marginal zone B-cell lymphoma, splenic marginal zone B-cell lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma, and primary central nervous system lymphoma and the copending claims are to a method of treating a blood cancer comprising administering to a subject in need thereof a therapeutically effective amount of a CDK inhibitor represented by Formula 1b or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of venetoclax or a pharmaceutically acceptable salt thereof
Both sets of claims refer to the same composition and/or derivatives thereof for the treatment of blood cancer. The current application claims are obvious variation.
In view of the foregoing, the copending application claims and the current application claims are obvious var/mjmd5awcxcxbiations of each other.
Claims 67-78 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 67-68 of U.S. Patent Application No. 18948242. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the instant are drawn to a method of treating a blood cancer in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of voruciclib or a pharmaceutically acceptable salt thereof, wherein: the blood cancer is selected from acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphocytic lymphoma (ALL), chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, intravascular large B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma, marginal zone B-cell lymphoma, extranodal marginal zone B-cell lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone B-cell lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma, and primary central nervous system lymphoma, and the subject is under treatment with a therapeutically effective amount of venetoclax or a pharmaceutically acceptable salt thereof.and the patented claims are to a method of treating a cancer such as acute lymphocytic lymphoma (ALL), diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, intravascular large B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma, marginal zone B-cell lymphoma, extranodal marginal zone B-cell lymphoma, ndal marginal zone B-cell lymphoma, splenic marginal zone B-cell lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma, primary central nervous system lymphoma, and triple negative breast cancer (TNBC), the method comprising administering to a subject in need thereof a therapeutically effective amount of a CDK inhibitor represented by Formula such as formula Ib wherein the second drug is a proteosome inhibitor.
Although the instant claims fails to recite that the second drug is a proteosome inhibitor The instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that 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 form a third composition that is to be used for the very same purpose since the idea of combining them flows logically from their having been individually taught in the prior art. Aplenic teaches the use of bortezomib a proteosome inhibitor as a standard chemotherapeutic Applying the same logic, given the teaching of the prior art methods of using bortezomid and venetoclax individually for treating acute myeloid leukemia, it would have been obvious to use both compounds for the treatment of acute myeloid leukemia because the idea of doing so would have logically followed from their having been individually taught in the prior art to be useful as therapeutic agents.
Both sets of claims refer to the same composition and/or derivatives thereof for the treatment of blood cancer. The current application claims are obvious variation.
In view of the foregoing, the patented claims and the current application claims are obvious variations of each other.
No claims are allowed.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 6/30/26
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