DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 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.
Status of the Claims
The listing of claims filed 25 October 2023 has been examined.
Claims 1–30 are pending. Claims 3–6, 10–18, 22, and 24–30 are amended.
Claims 31–34 are canceled.
Benefit of Earlier Filing Date
The instant application was filed 25 October 2023; is a national stage application of PCT/US2022/032589, filed 8 June 2022, and claims the benefit of U.S. Prov. Pat. App. Serial No. 63/208,662, filed 9 June 2021. Applicant’s claim is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 25 October 2023 is acknowledged and has been considered.
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.
Claim Rejections - 35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(i) Claims 1, 2, 4, 6–8, and 16–18 are rejected under 35 U.S.C. §§ 102(a)(1) and (a)(2) as being anticipated by US 2020/0115375 A1 (“Barda” – provided as U.S. Patent cite no 1 on IDS filed 10/25/2023).
Barda discloses compound 15 (shown below), which anticipates the formula in claim 1 as follows:
X = S; Y = N; R4a, R4b, R4c = H or F;
Z = N; R5 = Cl; R3 = H, F, or Cl; R6 = H; R1 = N-linked piperazine; R2 = H.
As shown in the scheme below, m = 0–2; R1 = F; and R2 = H, F, Cl.
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(Barda, ¶39).
(ii) Claims 1–4, 6–18, 22–25, and 27–29 are rejected under 35 U.S.C. § (a)(2) as being anticipated by WO 2022148422 A1 (“Beigene” – provided as foreign patent cite no. 4 on IDS dated 10/25/2023), claiming priority to PCT/CN2021/070898 (8 January 2021).
Beigene discloses compounds E13, E28, E236, and un-named compound (shown below), which anticipate the formula in claim 1 as follows:
X = S; Y = N or C(CN); R4a, R4b, = H; R4c = F or alkyl; Z = N; R5 = Cl; R3 = F; R6 = H; R1 = N-linked piperazine bridged with alkyl; R2 = O-CH2-R7; R7 = pyrrolidine substituted with alkyl and/or OH or tetrahydrofuran fused to an alkyl substituent.
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(Beigene, pp.53, 81).
Beigene discloses pharmaceutical compositions of the compounds. (Id., ¶14; p.479, claim 39).
Beigene discloses a method of treating pancreatic cancer with the compounds. (Id., ¶15; p.479, claim 40).
Allowable Subject Matter
Claims 5, 19–21, 26, and 30 are 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.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623