DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims and Response to Amendments
The amendments filed on July 14, 2026 have been acknowledged and entered. Claims 1-14 and 26-31 are pending. Claims 15-25 are cancelled. Note: previously allowed claims 5 and 11 are now rejected under 35 USC § 112(d) and previously allowed claims 4, 6, and 10-12 are objected to for the reasons stated below.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/EP2022/055808, filed on March 8, 2022. This application also claims the benefits of foreign priority to EP21161543.0, filed on March 9, 2021.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 14, 2026 has been entered.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of applicant's amendments and/or remarks.
Specification – Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 4, 6, 10-12, and 26 are objected to because of the following informalities:
In claim 4:
the variable, R1, has been cut off in general formula (IIa) (see circled region):
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.
Please correct accordingly.
In claim 6, the structures are very blurry to the point where certain variables in the structures are not legible (see below for some examples):
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…
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Please ensure that all structures listed in instant claim 6 are clear and legible.
In claims 10-12, please replace the structures currently recited with ones that are more clear and more legible.
In claim 26, the structures of compounds 1, 2, and 3 are missing. Below is what the Examiner currently sees:
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Claim 26 is further objected to as explained below:
Rule 1.141(a) states:Two or more independent and distinct inventions may not be claimed in one national application, except that more than one species of an invention, not to exceed a reasonable number, may be specifically claimed in different claims in one national application, provided the application also includes an allowable claim generic to all the claimed species and all the claims to species in excess of one are written in dependent form (§ 1.75) or otherwise include all the limitations of the generic claim. Claim 26 claims a large number of species of the generic claim, but in independent format. Multiple inventions may not be claimed in a single application unless they are species claims which are dependent upon the larger, generic claim. In the past, the Office has held a “reasonable number” to be five (5) species. The present claim contains well over this number of species. One could envision forty pages of species compounds in a single claim which is not dependent upon any genus claim. This would cause undue burden to the Office in examining such a large claim. Therefore, it is recommended that Claim 26 either be dependent from a larger, genus claim, or, that claim 26 incorporates all of the limitations of the genus claim. Applicants are invited to contact the examiner if further clarification is needed. No new matter is permitted. Appropriate correction is required.
Appropriate correction is required.
Examiner’s note on novelty and nonobviousness:
From nonfinal rejection (dated January 22, 2026)
The closest prior art references are the following:
Sava et al. (Sava) (Sava, G. P. et al. Cancer Metastasis Rev 2020, 39, 805-823.)
Liang et al. (Liang) (Liang, H. et al. Expert Opinion on Investigational Drugs 2021, 30, 61-76).
Novelty:
Both prior art references provide overviews of studies and literature concerning cyclin-dependent kinase 7 (CDK7) inhibitors as anticancer agents. Neither of the references disclose a compound falling within the scope of instant formula (I):
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. A further search conducted using STN database also did not identify any prior art disclosing compounds represented by instant formula (I).
Thus, the instant invention is considered novel.
Nonobviousness:
Both prior art references disclose CDK7 inhibitors reported in past studies and literature. However, the disclosed compounds possess core structures that are not structurally similar to the core structure of the instant compounds. In particular, the references mainly describe CDK7 inhibitors containing fused bicyclic ring systems. Neither reference provides a teaching, suggestion, or motivation to modify the disclosed compounds to incorporate the fused tricyclic ring structure recited in the instant claims.
Thus, the instant invention is considered nonobvious.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Written Description
Claims 28 and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The recitation of “cancer mediated by a CDK7” creates a “reach-through” aspect to the claim. Specifically, the claim is not limited to cancers presently recognized as “mediated by a CDK7”, but, instead, potentially reaches through to cancers whose relationship to CDK7 may only be discovered or established through future scientific investigation. In the instant case, the specification does not demonstrate possession of methods of treating cancers whose association with CDK7 was unknown or unrecognized at the time of filing, nor does it provide representative disclosure sufficient to show possession of such subsequently identified members of the claimed genus. Accordingly, the “reach-through” scope of the claim further demonstrates that the instant specification does not reasonably convey possession of the full scope of a “cancer mediated by a CDK7” as presently claimed.
Claim 30, which is dependent on claim 28, is also rejected for further requiring and/or reciting the limitation, “cancer mediated by a CDK7,” of claim 28 which does not have written description support.
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.
Claims 28 and 30 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.
The limitation “cancer mediated by a CDK7” renders the scope of the claims indefinite because the claim defines the cancer only by its functional relationship to CDK7, without identifying which cancers are encompassed or providing an objective standard for determining when a cancer is sufficiently “mediated” by a CDK7 to fall within the scope of the claim. It is therefore unclear whether the limitation only encompasses cancers that were established to be directly driven by CDK7 activity as of the effective filing date, or does it also encompass cancers that may subsequently be discovered or later determined to involve CDK7 activity. It is further unclear whether the limitation encompasses cancers in which CDK7 activity contributes to pathogenesis or does the limitation encompass any cancer for which CDK7 inhibition produces some biological or therapeutic effect. As such, the boundaries of the claimed genus are considered vague and indefinite.
Claim 30, which is dependent on claim 28, is also rejected for further requiring and/or reciting the indefinite limitation, “cancer mediated by a CDK7,” of claim 28.
Claim Rejections - 35 USC § 112(d)
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.
Claims 5, 11, and 29 are 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.
Claims 5 and 11 recite:
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and
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, respectively. Claims 5 and 11 state that R9 (circled above in formulas IIIf and VIIIf) is -C(=O)-CH=CH-R6, or -C(=O)-C≡C-R7. Both claims 5 and 11 are ultimately dependent on claim 1 which recites that if R1 is C1-3 alkyl, then R1 is substituted with -NH-C(=O)-CH=CH-R6, or -NH-C(=O)-C≡C-R7, NOT -C(=O)-CH=CH-R6, or -C(=O)-C≡C-R7 as recited in claims 5 and 11. Therefore, claims 5 and 11 fail to further limit the subject matter of the claim upon which it depends.
Claim 29 recites, “The method of claim 28, wherein the cancer is selected from leukemia… or benign neoplasm.” Claim 29 is dependent on claim 28 which is directed to a “method for the treatment of cancer mediated by a CDK7.” According to the instant specification, “cancer” refers to a malignant neoplasm (see pg. 34, line 10) which is different than a benign neoplasm. Therefore, “benign neoplasm” does not properly narrow a “cancer” as recited in instant claim 28.
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.
Allowable Subject Matter
Claims 1-3, 7-9, 13, 14, 27, and 31 are allowed. Claims 4, 6, 10, 12, and 26 are objected to and would be allowable once the appropriate corrections are made.
Conclusion
Claims 1-3, 7-9, 13, 14, 27, and 31 are allowed. Claims 4, 6, 10, 12, and 26 are objected to. Claims 5, 11, and 28-30 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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