FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Apr. 3, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claims 2, 12, 13, 16, 17, 19, and 23-25 have been canceled.
Claims 1 and 20 have been amended and incorporate no new matter.
Claims 14, 15, and 18 have been amended to remove dependencies upon cancelled claims.
No new claims have been added.
Thus, claims 1, 3-11, 14, 15, 18, and 20-22 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
No new Information Disclosure Statements (IDS) have been submitted.
ELECTION/RESTRICTION
Claims 1, 3-11, 14, 15, and 18 are allowable. Claims 10, 18, 21, and 22, previously withdrawn from consideration as a result of a restriction/species election requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions I and II, as set forth in the Office action mailed on Aug. 20, 2025, is hereby withdrawn and claims 10, 18, 21, and 22 are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
RESPONSE TO ARGUMENTS
The claim amendments overcome the rejections under 35 U.S.C. §§ 112 and 102.
Applicant’s arguments filed Apr. 3, 2026 (see Remarks, pp. 30-31), with respect to the rejection of claims 1-9, 11, 12, 14, 15, 19, and 20 under 35 U.S.C. § 103 over Koehler et al., have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection are set forth below.
NEW REJECTIONS
Claim Rejections - 35 USC § 112(d) – Improper Dependency
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, claim 20 depends from claim 1, which has been amended to define L as a structure of formula (III),
PNG
media_image1.png
162
608
media_image1.png
Greyscale
wherein
PNG
media_image2.png
158
720
media_image2.png
Greyscale
Thus, newly amended claim 1 requires compounds of formula (I) to have triazolyl, piperazinyl, or -C(O)-piperazinyl in the linker L.
However, at least compounds 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 as recited by claim 20 do not contain triazolyl, piperazinyl, or -C(O)-piperazinyl in the linker L. Thus, claim 20 fails to include all the limitations of the claim from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 21 is 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 pre-AIA the applicant regards as the invention.
Specifically, claim 21 is drawn to a method of treating a subject for a CDK9-mediated disease, comprising administering a therapeutically effective dose of a pharmaceutical composition comprising a compound of claim 1.
However, the specification defines the term "CDK9-mediated disease" only in non-limiting terms, by way of example (para. [0177]):
In some cases, the CDK9-mediated disease is cancer, e.g. cancer caused by aberrant expression of MYC- or MCL-1, a hematologic malignancy, or a solid tumor. In some cases, the disease is selected from the group consisting of: acute myelogenous leukemia, primary peritoneal carcinoma, chronic lymphocytic leukemia, relapsed multiple myeloma, non-Hodgkin's lymphoma, acute lymphoblastic leukemia, acute byphenotypic leukemia, advanced breast cancer, non-small cell lung cancer, and liver cancer.
Thus, claim 21 is drawn to a method of treating unspecified diseases which are not defined in clear, limiting terms. While certain "CDK9-mediated" diseases are disclosed, claim 21 encompasses the treatment of any "CDK9-mediated" disease. This limitation is ambiguous because, by defining the scope of diseases treated by an underlying molecular mechanism, the claim encompasses diseases which are not yet known to be caused or affected by the claimed molecular interaction. This generic, open-ended terminology fails to set forth the claimed patient population with sufficient clarity, rendering the metes and bounds of the claim indefinite.
Claims 21-22 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 pre-AIA the applicant regards as the invention.
Specifically, claim 21 is drawn to a method of treating a subject for a CDK9-mediated disease, comprising administering a therapeutically effective dose of a pharmaceutical composition comprising a compound of claim 1.
However, claim 21 fails to specify a subject to whom the compound is administered. Further, the specification fails to define the term "subject."
This generic, open-ended terminology fails to set forth the claimed patient population with sufficient clarity, rendering the metes and bounds of the claim indefinite.
Suggested language to unambiguously define the claimed patient population to whom the compound is administered might be, e.g., “a patient in need thereof,” i.e., a patient having the claimed disease which is capable of being treated with the claimed compounds.
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.
The factual inquiries 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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Koehler et al. (US 2023/0158159, of record).
Koehler et al. disclose bifunctional compounds that bind cyclin-dependent kinase 9 (CDK9) and/or promote targeted ubiquitination for the degradation of CDK9. The compounds can bind CDK9, a protein whose dysregulation is implicated in a variety of cancers, and can promote CDK9's degradation by recruiting an E3 ubiquitin ligase (e.g., Cereblon, VHL). The E3 ubiquitin ligase can ubiquitinate CDK9, marking it for proteasomal degradation.
In particular, Koehler et al. exemplify a compound (p. 56; claim 59, p. 95),
PNG
media_image3.png
301
946
media_image3.png
Greyscale
which is identical to compound 7.0 as recited by claim 20,
PNG
media_image4.png
366
734
media_image4.png
Greyscale
except that the compound of Koehler et al.:
is substituted at R1 by n-propyl instead of pentyl; and
the linker is -C(O)-(CH2O)3-(CH2)2-NH-, rather than -(CH2O)3-(CH2)2-NH-, i.e., the polyoxyethylene linker has one carbonyl group instead of zero.
However, the compound of Koehler et al. is disclosed as a species of formula (I),
PNG
media_image5.png
200
400
media_image5.png
Greyscale
wherein R1 includes unsubstituted alkyl, e.g., propyl (C3-alkyl) or pentyl (C5-alkyl) (claim 1). Further, Koehler et al. exemplify compounds with pentyl in this position (see, e.g., p. 55).
With regard to the linker L, formula (I) of Koehler et al. defines the linker L to include, e.g., substituted or unsubstituted aliphatic, substituted or unsubstituted heteroaliphatic, C(O), NH, or a combination thereof (claim 1):
PNG
media_image6.png
278
530
media_image6.png
Greyscale
Therefore, it would have been predictable to one of ordinary skill in the art as of the effective filing date to modify the compound of Koehler et al. to arrive at, e.g., compound 7.0 with a reasonable expectation of success, because Koehler et al. exemplify and claim compounds of formula (I) wherein the R1 substituent is C3 or C5 alkyl, and the linker is (CH2CH2O)n (poly-oxyethylene) which may be optionally substituted with -C(O)- or -NH- at any position. Moreover, the closely similar compounds of Koehler et al. are disclosed to have the same mechanism of action, as CDK9 inhibitors, and to be useful for treating the same diseases, e.g., cancer.
As recognized by MPEP § 2144.09, a prima facie case of obviousness may be made when chemical compounds have (1) very close structural similarities and (2) similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
ALLOWABLE SUBJECT MATTER
Claims 1, 3-11, 14, 15, and 18 are allowed.
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
CORRESPONDENCE
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. 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.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SARA E. TOWNSLEY/Examiner, Art Unit 1629
Prosecution Insights