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 .
DETAILED ACTION
Election of Species and Status of the Claims
Applicant’s election without traverse of
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as the single specific compound in the response filed on February 17th 2026 is acknowledged. Claims 1-15 are pending. Claim 14 is withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1-13 and 15 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on September 24th 2025, October 3rd 2024, March 26th 2024, and October 25th 2023 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Objections
Claim 15 is objected to for the phrase, “in the manufacture of a medicament for treating diseases related to KRASG12D mutation.” The phrase does not appear to be a part of the method described in claim 15. For the purpose of examination, the phrase will be treated as if were not present, leaving the complete method described prior to the phrase. Appropriate correction is required.
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 15 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 15 is indefinite for the phrase “a disease related to KRASG12D mutation,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the diseases recited in the claim. Specifically, it is unclear what constitutes a “relation” to a KRASG12D mutation, be it mediation by the described mutation, mediation by the KRAS kinase, or otherwise. The specification does not clarify this deficiency and provides no definition for what it means for a disease to be “related to KRASG12D mutation.” One of ordinary skill in the art therefore could not reasonably determine the full scope of diseases described by the claim, and claim 15 is thereby indefinite.
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.
Claims 1-7, 9, 10, 12, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xu (US20220315598 A1 effectively filed on December 2nd 2019).
The claims are directed towards a compound of Formula (III):
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.
Xu teaches the compound,
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(Xu, pg. 40).
Xu’s compound is anticipatory of claims 1- 7, 9, 10, and 12.
Claim 15 is directed towards a method of treating a KRASG12D mutation-related disease via administration of the compound of claim 1. One such disease related to the KRASG12D mutation would be RAS-mediated cancer. Xu teaches the treatment of RAS-mediated cancer (Xu, claim 20), anticipating claim 15.
Claim Rejections - 35 USC § 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.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Xu (US20220315598 A1 effectively filed on December 2nd 2019) in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012).
Claim 8 limits the R6 group on the compound of claim 1 to be selected from a group containing:
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.
Xu’s compound (above) differs in the R6 group in only 2 locations:
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,
that is the replacement of a methyl with a hydrogen and the replacement of a hydrogen with a hydroxide. One of ordinary skill in the art would have a reasonable expectation of success in performing both of these replacements, because they are well-known bioisosteric substitutions in the field of medicinal chemistry (Brown, pg. 17). Therefore, the compounds of claim 8 are prima facie obvious.
Nonstatutory 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.
Claim 1-13 and 15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 9, 13-14, 17, 19, 22, and 24-25 of copending Application No. 18/730,144 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches compounds including:
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(reference application, claim 17),
which is claimed by applicant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-12 and 15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/878,435 (reference application) in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the compound,
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(reference application, claim 21),
which differs from applicant’s compound, only in the bioisosteric replacement of a hydrogen with a hydroxide, which is known in the art of medicinal chemistry as a common bioisosteric replacement (Brown, pg. 17).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-13 and 15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 20, and 36-37 of copending Application No. 18/730,144 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations placed on the A and B ring structures of the reference application,
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,
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limit the structure in a manner in which one of ordinary skill in the art could reasonably envisage compounds of the instant application. For example,
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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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, Jeffrey 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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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Prosecution Insights