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 .
DETAILED ACTION
Priority and Status of Claims
1. This application is a 371 of PCT/CA2022/051876 12/21/2022, which claims benefit of 63/292,481 with a filing date 12/22/2021.
2. Claims 1-15, 23-25 and 30-31 are pending in the application.
Double Patenting
3. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 15 and 23-24 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable independently over claims 1 and 11 of Bray et al. US 12,624,949, over claim 1 of Sampson et al. US 11,059,832, over claim 1 of Sampson et al. US 10,501,474 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a method of treating a subject with acute myeloid leukemia, comprising administering an effective amount of Compound (I):
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or a pharmaceutically acceptable salt thereof, wherein the acute myeloid leukemia is FLT3 mutated acute myeloid leukemia; is acute myeloid leukemia with MLL-AF9 translocation; overexpresses wild-type FLT3;overexpresses transforming growth factor-b activated kinase 1 (TAK1);is TAK1 mutated; or is acute myeloid leukemia with increased TAK1 signaling, and the salt is tartrate salt, and ratio of compound (I) with tartaric acid is 1:1, see claims 1 and 23-24.
Applicants claim a method of treating a subject with acute lymphoblastic leukemia,
non- Hodgkin's lymphoma, Burkitt lymphoma, or diffuse large B-cell lymphoma,
comprising administering an effective amount of Compound (I):
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, or a pharmaceutically acceptable salt thereof, see
claim 15.
Bray et al. ‘049 claims a tartrate salt of Compound (I) represented by the following
structural formula:
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wherein the molar ratio between
compound (I) and tartaric acid is 1:1, wherein the tartrate salt is in a single crystalline
form, characterized by an X-ray powder diffraction pattern which comprises at least three
peaks chosen from 11.9°, 15.4°, 16.9°, 17.2°, and 25.6°±0.2 in 2θ, and used for treating
leukemia or lymphoma, see claims 1 and 11 in columns 19-20.
Sampson et al. ‘832 claims a compound represented by Formula (I-A):
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, see claim 1 in columns 94-95. A specific compound A30, i.e.,
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has been exemplified in column 55. Sampson et al. ‘832 compounds are used for treating leukemia or lymphoma, see column 12.
Sampson et al. ‘474 claims a compound or pharmaceutically acceptable salt thereof, wherein the compound is
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, see column 95. Sampson et al. ‘474 compound is used for treating leukemia or lymphoma, see column 12.
The difference between instant claims and Bray et al. ‘049 Sampson et al. ‘832 and ‘474 is the instant claims are embraced within the scope of Bray et al. ‘049 Sampson et al. ‘832 and ‘474.
One having ordinary skill in the art would find the claims 1, 15 and 23 prima facie obvious because one would be motivated to employ the compound and methods of use of Bray et al. ‘049 Sampson et al. ‘832 and ‘474 to obtain instant invention.
Additionally, the discovery of a new property or use, i.e., with MLL-AF9 translocation; overexpresses wild-type FLT3; overexpresses transforming growth factor-b activated kinase 1 (TAK1); is TAK1 mutated; or is acute myeloid leukemia with increased TAK1 signaling, of a previously known compounds and methods of use for treating leukemia or lymphoma of Bray et al. ‘049 Sampson et al. ‘832 and ‘474, even when that property and use are unobvious from the prior art, cannot impart patentability to claims to the known compounds, see In re Spada, 15 USPQ2d 1655 (Fed. Cir. 1990), and MPEP 2112.01. Therefore Bray et al. ‘049 Sampson et al. ‘832 and ‘474 renders obviousness over the instant invention.
Moreover, the crystalline compound of Bray et al. ‘049 would be converted into a free form after administration in a patient, thus it would not be distinct from the instant compound.
The motivation to make the claimed methods of use derived from the known compound and methods of use of Bray et al. ‘049 Sampson et al. ‘832 and ‘474 would possess similar activity to that which is claimed in the reference.
Claim Objections
4. Claims 2-14, 25 and 30-31 are objected to as being dependent on rejected claims 1 and 15.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
May 29, 2026
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