DETAILED ACTION
A non-final Office action was mailed 20 February 2026 (“Office Action”).
Applicant’s reply to the Office Action was received 19 May 2026 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 1, 2, 4–9, and 11–30 are pending. Claims 3, 10, and 31–34 are canceled. Claim 1 is amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 25 March 2026 is acknowledged and has been considered.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Claim Objections
Claims 25–30 are objected to for minor informalities.
The claims recite KRas G12D, PD-1, PD-L1, CD4/CDK6, EGFR, ERK, and SHP2. To avoid confusion, acronyms should be defined in the claims, at least in the first instance of use.
Appropriate correction is required.
Response to Arguments
Applicant did not address the claim objections by amendment or argument.
Claim Rejections - 35 U.S.C. § 102
Claims 1, 2, 4, 6–9, and 11–29 are rejected under 35 U.S.C. § (a)(2) as being anticipated by WO 2022/148422 A1, claiming priority to PCT/CN2021/070898 (8 January 2021) (“Beigene”) [foreign patent cite no. 4 on IDS dated 25 October 2023].
Beigene discloses, inter alia, compounds E104 and E106 (shown below), which anticipates the formula in claim 1 as follows:
X = S; Y = C(CN); Z = N;
R1 = N-linked piperazine bridged with alkyl substituent;
R2 = O-CH2-R7; R7 = pyrrolidine fused to an alkyl substituent to form bicyclic ring;
R3 = halogen (F); R5 = halogen (Cl) or alkyl substituted by three R8; R8 = halogen (CF3);
R4a, R4b, = H; R4c = halogen (F); and
R6 = H.
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(Beigene, p.74).
Beigene discloses pharmaceutical compositions. (Id., ¶14; p.479; claim 39).
Beigene states: “KRas is one of the most frequently mutated genes in human cancers. . . . KRas mutation can be found in about 20% of human cancers, including pancreatic cancer, colorectal cancer, lung cancer, skin cancer etc.” (Id., ¶3).
Beigene discloses a method of treating “a condition treatable or preventable by inhibition of the function of KRAS protein with G12D mutation.” (Id., ¶12).
Beigene discloses a method of treating pancreatic cancer, including cancer having a KRas protein mutation. (Id., ¶15; p.479; claim 40).
Response to Arguments
Applicant addressed the rejection in the Office Action by claim amendment and did not provide any arguments.
Claim Rejections - 35 U.S.C. § 103
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.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966); MPEP § 2141(II).
Claim 30 is rejected under 35 U.S.C. § 103 as being unpatentable over Beigene in view of WO 2022/232332 (“Amgen”) [foreign patent cite no. 4 on IDS dated 25 March 2026].
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
The discussion of the compounds, compositions, and methods in Beigene in the rejection above is incorporated herein by reference for the purpose of this rejection.
Amgen discloses compounds related to those in Beigene, along with compositions and methods of using the same. (Amgen, pp.2–4). Among other things, Amgen discloses a method of administering the compounds with another therapeutic agent in a combination therapy. (Id., pp.109–123). The second agent can be, e.g., PD-1 inhibitor, a PD-L1 inhibitor, etc. (Id.).
Ascertaining the differences between the prior art and the claims at issue
Beigene does not disclose a combination therapy.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application does not include evidence related to a combination therapy.
The question of obviousness
Based on the above factors, it would have been prima facie obvious for a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Beigene and Amgen to arrive at the claimed method because the cited references disclose related compounds and related methods of using those compounds to treat cancer. One of ordinary skill in the art would have had a reasonable expectation of success in combining the disclosures of the cited references because combination therapy is routinely used in cancer treatment, the cited references disclosure are directed to related compounds for treating cancer, and combination therapy can improve patient outcome.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Notice of Claim Status Change
Claims 19–21, 26, and 30 were indicated as being allowable in the Office Action. The indication of allowability is hereby withdrawn. This is a non-final Office action.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks, can be reached on 571-270-7682.
/J.M.N./Patent Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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