DETAILED ACTION
Claims 1-33, submitted on September 30, 2024, are pending in the application. Claims 1-9 and 16-27 are allowed. Claims 10-15 and 28-33 are rejected for the reasons set forth below.
Allowable Subject Matter
Claims 1-9 and 16-27 are allowed. Moustakim et al. and Heidenreich et al., both discussed below, are cited as the closest prior art. The R¹ and R² substituents of the compounds of the instant claims are patentably distinct from the substituents of the corresponding compounds disclosed in these two references.
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 of the Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claims 10 and 28 are objected to because the phrase “to a subject in need thereof” should be added. Appropriate correction is required.
Claim Rejections – 35 USC § 112
The following is a quotation 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.
Claims 10-15 and 28-33 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for treating acute myeloid leukemia, does not reasonably provide enable-ment for all acute leukemias. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The claimed invention is generally in the pharmaceutical arts. The independent claims are drawn to a “method of treating an acute leukemia,” that is, any acute leukemia regardless of the disease etiology. See instant claims 10 and 28. Dependent claims are drawn to narrower embodiments of the leukemia. See, e.g., claims 11-12 and 29-30. Leukemia encompasses a broad range of different diseases, each with their own unique pathology. For example, Olsson, Cancer Metastasis Rev. 1983;2(2):153-63 discloses that “leukemia comprises a large group of different diseases that can be identified by morphology in combination with immunological markers” (see abstract). Olsson further teaches that “[l]ow therapeutic efficiency of the currently used treatment modalities may, in fact, be caused by phenotypic heterogeneity that results in rapid adaptation and selection of leukemia cell variants insensitive to a given therapeutic agent” (p. 161). Similarly, Bispo et al., Cold Spring Harb. Perspect. Med. 2020;10(6):a034819 discloses that most leukemias “are sporadic and the specific etiology remains elusive” and “research shows that these malignancies often develop in the context of genetic abnormalities, immunosuppres-sion, and exposure to risk factors like ionizing radiation, carcinogenic chemicals, and oncogenic viruses” (see abstract). Finally, Abdel-Aziz, Biochem. Pharmacol. 2023;215:115709 discloses that “[a]cute myeloid leukemia (AML) is an aggressive type of blood cancer with poor survival rate and limited therapeutic options” (p. 1). AML is characterized by “drug resistance, relapse and poor survival” (p. 2; see also Fig. 1 and the discussion thereof). Taken together, these three references are evidence that this technology area, broadly considered, is characterized by a high level of unpredictability. On the other hand, the following two documents are cited as repre-senting the closest prior art:
Moustakim et al., Angew. Chem. Int. Ed. Engl. 2018;57(50):16302-07.
Heidenreich et al., J. Med. Chem. 2018;61(23):10929-34.
Both of these references teach or suggest using structurally similar compounds in the treatment of acute myeloid leukemia. See, e.g., Moustakim at p. 16302 and Heidenreich at p. 10929.
In view of the foregoing, one would look to applicant’s specification for information about how the claimed compounds are used in actual clinical practice. The specification (pp. 28-254) includes a lengthy discussion about how to make the compounds at issue. It also includes evidence (see Example 106 and Example 107 at pp. 254-262) that the compounds reduce cell viability of MV4-11 cells (an AML cell line). Given the Examples in applicant’s specification, together with the teachings of Moustakim and Heidenreich, the examiner acknowledges that the claims are enabled for a method of treating AML. Treating other types of cancer within the scope of the claims, however, would present a burden of undue experimentation to the skilled artisan.
Related Prior Art and Co-Pending Application
WO 2021/127166 A1 by Khan et al. (cited in applicant’s information disclosure statement submitted on March 4, 2025) is noted as disclosing similar compounds. The instant claims are patentably distinct because of the R¹ and R² substituents. The instant claims are also patentably distinct from the claims of co-pending application no. 17/757,492 for the same reasons.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Exam-iner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interview practice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
January 21, 2026