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 .
Status of the Claims
Claims 1-23 are pending in the instant application and subject to examination herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/11/2024 and 02/02/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 18 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 18 is drawn to a group of specific compounds but does not illustrate or articulate what are the specific compounds being claimed. MPEP § 2173.05(s) states the following:
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Compounds to be claimed in claim 18 must each be incorporated into the claim by drawing or by their chemical names. Since the compounds can be incorporated by name, it is not the case that there is no practical way to define the invention in words.
Claims Free of the Prior Art
Claims 1-17 and 19-22 are allowed. The following is an examiner’s statement of reasons for allowance: Prior art does not teach or reasonably suggest, alone or in combination, a compound of Formula (I) or pharmaceutically acceptable salt thereof, as claimed in claim 1. Prior art does not teach or reasonably suggest, alone or in combination, a pharmaceutical composition comprising a compound of Formula (I), or a pharmaceutically acceptable salt thereof, as claimed in claim 1 together with a pharmaceutically acceptable carrier, including comprising an additional anti-cancer agent. Prior art does not teach or reasonably suggest, alone or in combination, a method of inhibiting KRAS G12C protein comprising contacting KRAS G12C protein with the compound of claim 1 or the pharmaceutically acceptable salt thereof. Prior art does not teach or reasonably suggest, alone or in combination, a method of treating cancer comprising administering a compound of claim 1 or the pharmaceutically acceptable salt thereof to a subject in need thereof, including wherein the method includes administering an additional active agent to the subject.
Closest Prior Art
The closest prior art is found in Shibata (WO 2021/085653 A1)1. Shibata discloses an antitumor agent comprising a compound or a pharmaceutically acceptable salt thereof that covalently binds to GTP-bound KRASG12C as an active ingredient (Abstract). Shibata discloses a genus of compounds as part of the invention disclosed therein, designated as Shibata’s Formula (i), shown below (paragraph [0010]: page 5, lines 8-10):
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202
554
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Shibita discloses that moieties “A”, “D” and “E” are ring systems (paragraph [0010]: page 5, lines 12-14), and further discloses specific compounds that are similar to the genus of instant Formula (I), for example Shibata’s “Example 1”2 shown below (paragraph [0332])
Claim Number(s) of Instant Application
Instant Application
Shibata
1
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304
406
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wherein:
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428
716
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Shibata’s “Example 1” differs from the scope of instant Formula (I) in that the polycyclic ring system comprising Shibata’s rings “A” and “D” does not include an aliphatic bridge as found in instant Formula (I), and Shibata’s ring “D” is a phenyl rather than a bicyclic heteroaryl ring system, and further because the linking group between Shibata’s polycyclic ring system (A + D) and the phenyl ring adjacent to the beta-amino acrylamide moiety is an amide linking group in Shibata’s Example 1, whereas instant Formula (I) allows only a keto group in this position.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (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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Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/W.J.Y./Examiner, Art Unit 1629
1 Cited in Applicant’s Information Disclosure Statement dated 12/11/2024.
2 3-cyano-N-(3-(2-ethyl-1-methyl-6-(trifluoromethyl)-1H-benzo[d]imidazol-5-yl)phenyl)-4-((E)-4-(((1r,4r)-4- methoxycyclohexyl)amino)but-2-enamido)benzamide
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