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 .
Application Status
The preliminary amendment filed on 9/12/2024 is acknowledged. Claims 1-3, 5, 15-16, 18-19, 21-22, 24, 30-34 and 36-39 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 3/27/2025 has been considered except where lined through.
Claim Rejections - 35 USC § 102
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.
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)(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.
Claim(s) 1-3, 5, 15-16, 19, 24, 32, 34 and 36-39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (US2023/0081426A1 (2023-03-16), claims priority to 63/080,548 filed on 2020-09-18).
Zhang et al. teach compounds having the general formula I:
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(abstract). Specifically, Zhang et al. teach compounds including, but not limited to,
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(P-0031),
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271
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(P-0034) and
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276
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(P-0047) which read on the instantly claimed compound of formula (1) as well as the 18th compound of claim 34 (see Table 1A). Moreover, Zhang et al. teach a pharmaceutical composition comprising a compound of formula I and a pharmaceutical acceptable carrier, as well as, a method of treating a disease or condition medicated by KRAS such as pancreatic cancer, lung cancer and colorectal cancer (see at least claims 74-82 of Zhang).
Note: Although there is reference to specific compounds taught by Zhang above, the listing does not represent an exhaustive list as there are numerous compounds taught by Zhang which anticipate the claimed generic formula I.
Claim(s) 1-3, 5, 15-16, 1819, 24, 32-34 and 36-39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dai et al. (US2023/0242544A1 (2023-08-03), claims priority to PCT/CN2020/0099104 filed on 2020-06-30).
Dai et al. teach compounds having the general formula I:
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(abstract). Specifically, Dai et al. teach specific compounds including, but not limited to,
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(cmpd 68) and
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(cmpd 109) which reads on the instantly claimed compound of formula (I) and a compound within claim 34 (see Table A). Moreover, Dai et al. teach a pharmaceutical composition comprising a compound of formula I and a pharmaceutical acceptable carrier, as well as, a method of treating a disease or condition medicated by KRAS such as pancreatic cancer, lung cancer and gastric cancer (see at least claims 50-61 of Dai et al. ).
Note: Although there is reference to a specific compound taught by Dai et al. above, the listing does not represent an exhaustive list as there are numerous compounds taught by Dai et al. which anticipate the claimed generic formula I.
Claim(s) 1-3, 5, 30-31 and 36-39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kwai et al. (WO2021/107160A1, 2021-06-03, claims priority to JP2019-216165, 2019-11-29).
Kwai et al. teach a compound having the generic formula 1:
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458
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(abstract). Specifically, Kwai et al. teach specific compounds encompassed by formula 1 including, but not limited to,
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(cmpd 14) and
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(cmpd 15) which read on the instantly claimed compounds of general formula I (page 152). Moreover, Kwai et al. teach a pharmaceutical composition comprising a compound of formula 1 and a pharmaceutical acceptable carrier, as well as, a method of treating a disease or condition medicated by KRAS such as pancreatic cancer, lung cancer and gastric cancer (see at least claims 38-39 and paragraphs 0221 and 0244 of Kwai et al. ).
Note: Although there is reference to a specific compound taught by Kwai et al. above, the listing does not represent an exhaustive list as there are numerous compounds taught by Kwai et al. which anticipate the claimed generic formula I.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5, 15-16, 18-19, 21-22, 24, 30-34 and 36-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-8, 11, 15-17, 20-23 and 25-28 of copending Application No. 18550237 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application, specifically the compound of general formula I:
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substantially overlap with the compounds of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5, 15-16, 18-19, 21-22, 24, 30-34 and 36-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 14-15, 19, 28-29, 31-32 and 45-52 of copending Application No. 18450847 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application, specifically the compound of general formula I:
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substantially overlaps with the compounds of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Therefore, No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 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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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626