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 .
Priority
This Application filed on 10/18/2023 is a CON of PCT/EP2022/060294 filed on 04/19/2022 which claims foreign priority to EP 21169352.8 filed on 04/20/2021.
DETAILED ACTION
Applicant’s arguments filed on 3/16/2026 regarding the restriction requirement have been considered. The election of Group I, claims 1-7 and MK2a inhibitor without traverse is acknowledged.
The claims corresponding to the elected subject matter are 1-7 are herein acted on the merits.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 9/5/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The rejections are as below:
Claim Rejections- 35 USC 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (WO2018183559 - IDS) in view of Baldus et al. (BAALC, a novel marker of human hematopoietic progenitor cells. Experimental Hematology 31 (2003) 1051–1056).
Lee et al. teaches a method of reducing resistance to chemotherapy in a subject who has cancer, the method comprising administering to the subject an effective amount of a p38 MAPK inhibitor prior to administering chemotherapy; wherein the cancer is acute myelogenous leukemia (AML). The p38 MAPK inhibitor is selected from the group consisting of SB203580; Doramapimod (BIRB 796); SB202190 (FHPI); Ralimetinib (LY2228820); VX-702; PH-797804; VX-745; TAK-715; Pamapimod (R-1503, Ro4402257); BMS-582949; SB239063; Losmapimod (GW856553X); Skepinone-L; Pexmetinib (ARRY-614); Hydroxy quinazoline; AL 8697; AMG 548; AMG-47a; ARRY-797; CGH 2466 dihydrochloride; CMPD-1; CV-65 (see claims 1-3). Lee et al. incorporates by reference subjects such as, de novo AML patients and those with myelodysplastic syndromes.
While the reference teaches acute myelogenous leukemia (AML), the reference does not specify AML with high expression of BAALC.
Baldus et al. teaches BAALC (Brain And Acute Leukemia, Cytoplasmic), a novel molecular marker involved in leukemia, is highly expressed in a subset of patients with acute leukemia.
It would have been obvious to one of ordinary skill in the art at the time of filing the invention to treat AML with high expression of BAALC. The motivation to treat AML with high expression of BAALC is because Lee et al. generally teaches treatment of AML and Baldus et al. teaches BAALC is highly expressed in some patients with acute leukemia. Hence, a skilled artisan would have had reasonable expectation of successfully achieving treatment of AML with high expression of BAALC.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Bogenberger et al. (604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster II| December 6, 2014. MK2a Substrate-Selective p38 Inhibitor CMPD1 Selectively Synergizes with HDAC Inhibitors in CD34+ Cells from Myeloid Malignancies. Blood (2014) 124 (21): 2239 - IDS) in view of Lee et al. (WO2018183559 - IDS).
Bogenberger et al. teaches the putative MK2a substrate-selective p38 inhibitor CMPD1 selectively potentiates the activity of SAHA in all AML cell lines tested (N=8), as well as in ex vivo cultures of primary myeloid malignancies (N=14), including polycythemia vera, chronic myelomonocytic leukemia, MDS/myeloproliferative neoplasm overlap syndrome, MDS transformed to AML, and de novo AML.
While the reference teaches cell line data, the reference does not specify administering the active to a living being.
Lee et al. teaches a method of reducing resistance to chemotherapy in a subject who has cancer, the method comprising administering to the subject an effective amount of a p38 MAPK inhibitor prior to administering chemotherapy; wherein the cancer is acute myelogenous leukemia (AML). The p38 MAPK inhibitor is selected from CMPD-1 (see claims 1-3).
It would have been obvious to one of ordinary skill in the art at the time of the invention to treat AML in a patient. The motivation to treat AML in a patient is because Lee et al. teaches administering to the subject an effective amount of a p38 MAPK inhibitor including CMPD-1. Hence, a skilled artisan would have had reasonable expectation of successfully achieving efficacy in a patient.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bogenberger et al. (604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster II| December 6, 2014. MK2a Substrate-Selective p38 Inhibitor CMPD1 Selectively Synergizes with HDAC Inhibitors in CD34+ Cells from Myeloid Malignancies. Blood (2014) 124 (21): 2239 - IDS) in view of Lee et al. (WO2018183559 - IDS), as applied to claims 1-3 and 5-7, further in view of Baldus et al. (BAALC, a novel marker of human hematopoietic progenitor cells. Experimental Hematology 31 (2003) 1051–1056).
While the reference teaches cell line data, the reference does not specify administering the active to a living being having AML with high expression of BAALC.
Baldus et al. teaches BAALC (Brain And Acute Leukemia, Cytoplasmic), a novel molecular marker involved in leukemia, is highly expressed in a subset of patients with acute leukemia.
It would have been obvious to one of ordinary skill in the art at the time of filing the invention to treat AML with high expression of BAALC. The motivation to treat AML with high expression of BAALC is because Bogenberger et al. and Lee et al. generally teach treatment of AML and Baldus et al. teaches BAALC is highly expressed in some patients with acute leukemia. Hence, a skilled artisan would have had reasonable expectation of successfully achieving treatment of AML with high expression of BAALC.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
