DETAILED ACTION
The amendment submitted on July 28, 2026 has been entered. Claims 1-33 are pending in the application. Claims 1-9 and 16-27 are allowed. Claims 12-13 and 30-31 are objected to but would be allowable if rewritten in independent form. Claims 10-11, 14-15, 28-29, and 32-33 are rejected for the reasons set forth below.
Allowable Subject Matter
Claims 1-9 and 16-27 remain allowed for the reasons discussed in the prior action.
Claims 12-13 and 30-31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Withdrawn Rejections/Objections
The objection to claims 10 and 28 for a minor informality is withdrawn in view of appli-cant’s corrective amendment.
The rejection of claims 12-13 and 30-31 under 35 U.S.C. 112(a) is withdrawn because these claims are drawn to a meth of treating acute myeloid leukemia.
Response to Arguments
Applicant argues that “the term ‘acute leukemia’ is a well-defined clinical term that refers to two principal disease categories: acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The specification expressly identifies these as the relevant embodiments.” See applicant’s Remarks, submitted July 28, 2026, a pp. 12-14. The examiner agrees that these diseases are clinically recognized in the prior art. The problem here is that the evidence in support of enablement is not commensurate in scope with the working examples provided by applicant.
“As long as the specification discloses at least one method for making and using the claimed invention that bears a reasonable correlation to the entire scope of the claim, then the enablement requirement of 35 U.S.C. 112 is satisfied.” See MPEP 2164.01(b). It is important to remember, however, that the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. Furthermore, the scope of enablement must only bear a reasonable correlation to the scope of the claims. With respect to the breadth of a claim, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. See MPEP 2164.08.
Here, the prior art clearly identifies leukemia as “a large group of different diseases.” Inasmuch as they are different diseases, their etiologies would be different as well. It is therefore not plausible to one treatment would be effective across such a wide range of pathologies. Applicant’s arguments, however, with respect to claims 12-13 and 30-31 are persuasive and these claims would be allowable if rewritten in independent form.
Applicant’s arguments with respect to claims 10-11, 14-15, 28-29, and 32-33 have been fully considered but are nor persuasive. The rejection below is therefore maintained.
Maintained Rejections 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 10-11, 14-15, 28-29, and 32-33 remain rejected under 35 U.S.C. 112(a), because the specification, while being enabling for treating acute myeloid leukemia, does not reasona-bly provide enablement 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 (both cited in the prior action) are cited as representing 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.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advi-sory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Examiner 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/interviewpractice. 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
October 3, 2026
