DETAILED ACTION
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 .
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.
Current Status of 18/250,799
This Office Action is responsive to the election received 23 February 2026.
Claims 1-9 and 11-15 are currently pending.
Election/Restrictions
Applicant's election with traverse of Group I, being claims 1-4, 6, and 8 in the reply received on 23 February 2026, is acknowledged. Applicant provides no grounds for their traversal. The Examiner does not find Applicant’s grounds for traversal persuasive.
However, no prior art or double patenting art was found to reject instant claims 1-4, 6, or 8, due to Applicant’s amendments submitted along with their response to the Restriction Requirement. Therefore, in accordance with MPEP 821.04, no claims are currently withdrawn due to Applicant’s election.
Priority
Applicant’s claim for the benefit of the prior-filed applications PCT/CN2021/126790 (filed 27 October 2021) and CN 202011187029.7 (filed 29 October 2020) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The Examiner has determined, for the purposes of the instant action, that the effective filing date of the instant claims is 27 October 2021, at least due to the lack of an English translation of the earlier priority document. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Information Disclosure Statement
The information disclosure statements (IDS) received on 27 April 2023 and 5 February 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, these information disclosure statements are being considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities: A proper Markush group should have commas separating the alternative members. See MPEP 2173.05(h). Commas should be placed in claim 4 between the alternate chemical structures. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Claim 5 appears to contain two sentences, which is not the form insisted upon by the Office. See MPEP 608.01(m). Applicant may choose to replace the phrase “Ar2 -is substituted with the PG. PG is a protective group” with the phrase “Ar2 is substituted with the PG.”, and the phrase “PG is a protective group;” may be added before the phrase “and Ar2’ is a substructure”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 9 and 14-15 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in making this determination include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. While all of these factors are considered, a sufficient number for a prima facie case are discussed below.
Claims 9 and 14-15 recite methods of preventing cancers through the administration of a compound of instant claim 1. All humans are susceptible to developing cancer. NCI (NIH National Cancer Institute, “Risk Factors for Cancer” 2015) teaches that cancer can be caused by inherited genetic mutations and via aging. It is not clear how the instantly claimed compounds could prevent the formation of cancer through these routes. The identity of the patient or patient population that one of ordinary skill in the art would choose to treat with a compound of instant claim 1, for the prevention of cancer, is entirely unclear. One of ordinary skill in the art would not reasonably read the instant claims and determine that all humans should be administered a compound of claim 1, regardless of their age, gender, comorbidities, risk factors for the development, and other factors. Therefore, the artisan would not know which humans should be administered the instantly claimed compounds. This represents an insufficient amount of direction provided by the inventor. Additionally, due to the low level of predictability in the chemical arts, one of ordinary skill in the art would not know if there would be unique risks to specific patient populations, such as pediatric or elderly patients. Applicant may choose to remove the aspect of “prevention” from these claims.
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 5 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 does not mention the reaction scheme shown within the text of the claim. This causes it to be unclear to the reader whether or not the entire reaction shown is required by the claim. This renders claim 5 indefinite. Applicant may choose to add the phrase “wherein a compound of formula (I-1) reacts to form a compound of formula (I)” immediately before the reaction shown in claim 5.
Allowable Subject Matter
Claims 5, 9, and 14-15 stand rejected under 35 USC 112. Claims 1-4, 6-8, and 11-13 are currently allowable. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is that of LOU (WO 2020/135507 A1; International Publication Date 2 July 2020), which teaches similar compounds. LOU generally teaches compounds that are described as inhibitors of CDK4, CDK6, and CDK9 kinases as anti-tumor agents (page 106 of the attached LOU document with translation). LOU teaches compound T-46 on page 68 therein, as shown below.
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204
468
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The compound taught by LOU contains a 9-membered heterocycle that does not fall within the scope of instant claim 1. Specifically, the Rf substituent within instant claim 1 is no longer allowed to be any type of heterocycle. The Examiner is not aware of a reason why one of ordinary skill in the art would select a compound of LOU and modify it to fall within the scope of instant claim 1.
Conclusion
Claims 5, 9, and 14-15 stand rejected under 35 USC 112. Claims 1-4, 6-8, and 11-13 are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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