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
Election of Species and Status of the Claims
Applicant’s election with traverse of Compound Z-11,
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as the ‘single compound,’ encompassing claims 1, 7, 9, 10, 12-14, 16-19, and 21-24 in the response filed on December 31st 2025 is acknowledged. Applicant argues that the amended compound genus makes a significant contribution over the prior art of CN 107427521A, and the election of species requirement is therefore invalid. However, additional prior art remains (see below). The election of species requirement is thereby maintained. Claims 1, 7, 9, 10, 12-19, and 21-24 are pending and are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on August 15th 2024, April 11th 2024, and July 21st 2023 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and its dependent claims 7, 9, 10, 12-13, 16-19, and 21-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 and its dependent claims are indefinite for the phrase “(R0)m represents that hydrogens on ring A are substituted with m R0 groups, m being 0.” The amended claim 1 does not recite a “ring A.” Furthermore, “m=0” is equivalent to stating that R0 is not present.
Claims 17 and 18 are indefinite for the phrase “disease associated with or mediated by CDK9 activity,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claims from the claim language.
Specifically, the full breadth of the diseases “associated with or mediated by” CDK9 activity is not defined by the specification and is not a known term of art. The extent of the term as defined by applicant is found in paragraphs [0043] of the specification:
“In the present disclosure, the diseases associated with or mediated by CDK9 activity include diseases associated with or involving CDK9 activity (e.g., CDK9 overactivity), as well as conditions accompanying these diseases. The CDK9 overactivity refers to increased CDK9 enzymatic activity as compared to normal and non-diseased cells; or increased CDK9 activity leading to undesired cell proliferation, or decreased or insufficient programmed cell death (apoptosis); or mutations leading to constitutive activation of CDK9. The hyperproliferative diseases include diseases involving undesired or uncontrolled proliferation of cells, including the diseases involving reduced or insufficient programmed cell death (apoptosis). The compounds according to the present disclosure can be used to prevent, inhibit, block, reduce, lower, control, etc. cell proliferation and/or cell division, and/or produce apoptosis. The method includes administering, to a subject (including a mammal, including a human) in need thereof, a certain amount, which was effective to treat or prevent the diseases, of the compound, or the pharmaceutically acceptable salt, hydrate, or solvate thereof according to the present disclosure.”
One of ordinary skill in the art would not reasonably be able to determine the metes and bounds of the “diseases associated with or mediated by CDK9 activity,” but would only infer a loose categorization of conditions wherein over-expression of CDK9 enzymatic activity is present. Furthermore, such activity is present not only in the hyperproliferative diseases described by applicant, but in a varying array of conditions, as diverse as viral infections, conditions related to muscle differentiation, and heat shock1.
Applicant provides examples of CDK9-mediated hyperproliferative diseases in paragraph [0044], but nowhere defines the full breadth of the conditions addressed by the claims. As one of ordinary skill in the art could not reasonably determine the full scope of “diseases associated with or mediated by CDK9 activity,” claims 17 and 18 are indefinite.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1, 7, 9, 10, 12-19, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Mikochik (WO 2020/092134A1 published on October 29th 2019) in view of Lima (Lima et al., Current Topics in Medicinal Chemistry, 2019, Vol. 19, No. 19 pg. 1734-1750).
Claims 1, 7, 9, 10, 12-15, and 21-24 are directed towards applicant’s elected species of compound Z-11:
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Mikochik teaches the compound,
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(Mikochik, pg. 9, compound 42).
Applicant’s Z-11 differs from Mikochik’s compound primarily in the addition of a branched alkane:
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One of ordinary skill in the art would have a reasonable expectation of success in making this addition, because it qualifies as a homologation, which is a well-known strategy in the field of drug development. See Lima, who describes homologation in the field of drug discovery, including the addition of branched alkane fragments (Lima, pg. 1735-1736, section 3). One of ordinary skill in the art would therefore have a reasonable expectation of success in developing compound Z-11 and claims 1, 7, 9, 10, 12-15, and 21-24 are prima facie obvious.
Claim 16 is directed towards a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier. Mikochik teaches such a pharmaceutical composition (Mikochik, pg. 80, claim 8), and claim 16 is therefore prima facie obvious.
Claim 17 is directed towards a method for treating or preventing a disease associated with or mediated by CDK9 activity. Mikochik teaches the treatment of CDK9-mediated diseases (Mikochik, pg. 80, claim 9), and claim 17 is prima facie obvious.
Claims 18-19 limit the disease of claim 17 to cancers such as leukemia. Mikochik teaches the treatment of acute myelogenous leukemia (Mikochik, pg. 81, claim 11), and claims 18-19 are prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 See Franco, who describes diseases related to CDK9 activity: Franco et al., CDK9: A key player in cancer and other diseases. J Cell Biochem. 2018; 119: 1273–1284