Prosecution Insights
Last updated: October 04, 2026
Application No. 18/873,229

TETRAHYDROPYRIDO 3,4-D PYRIMIDINE DERIVATIVES AS KRAS INHIBITORS

Non-Final OA §112
Filed
Dec 09, 2024
Priority
Jun 10, 2022 — provisional 63/351,134 +1 more
Examiner
COUGHLIN, MATTHEW P
Art Unit
Tech Center
Assignee
Bristol-Myers Squibb Company
OA Round
1 (Non-Final)
71%
Grant Probability
Favorable
1-2
OA Rounds
7m
Est. Remaining
84%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allowance Rate
712 granted / 999 resolved
+11.3% vs TC avg
Moderate +12% lift
Without
With
+12.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
59 currently pending
Career history
1044
Total Applications
across all art units

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
24.4%
-15.6% vs TC avg
§102
18.9%
-21.1% vs TC avg
§112
31.8%
-8.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 999 resolved cases

Office Action

§112
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 Claims 1-4, 6, 8-11, 14, 15, 17, 23 and 25-31 are pending in the application. Claims 1-4, 6, 8-11, 14, 15, 17 and 25-31 are rejected. Claim 23 is allowed. Information Disclosure Statement The Examiner has considered the Information Disclosure Statement(s) filed on October 22nd, 2025. Priority Due to the presence of intervening prior art (WO 2024/229444 A2), the disclosure of Provisional Application No. 63/351,134 was reviewed. Since the provisional application supports each claim under examination, the earliest effective filing date for prior art purposes is June 10th, 2022. Claim Objections In the definition of R5 in claim 1, the option “NRaRb-C(O)-C1-C6-alkyl)” should be amended to delete the closed parenthesis at the end of the term. 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. Claims 1-4, 6, 8-11, 14, 15, 17 and 25-31 are 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. Claims 1-3, 6, 8-11, 14, 15, 17 and 25-31 are rejected as indefinite based on the definition of variable A. Claim 1 recites that A is a “nitrogen-containing … ring system … optionally containing one or two heteroatoms independently selected from nitrogen, oxygen, and sulfur…”. The broad generic term appears to require the presence of at least one nitrogen atom but the definition also recites that heteroatoms are independently selected from a list that, on its face, would not otherwise appear to require the selection of nitrogen. There appear to be several interpretations: “A” must contain one nitrogen heteroatom and can optionally further contain two additional heteroatoms independents selected from nitrogen, oxygen, and sulfur; “A” must contain one nitrogen heteroatom and the ring can contain one additional heteroatom selected from nitrogen, oxygen, and sulfur; “A” need not contain any heteroatoms but when it does, it contains up to two heteroatoms selected from nitrogen, oxygen, and sulfur; and “A” must contain one or two heteroatoms and each is independently selected from nitrogen, oxygen, and sulfur. Interpretation (2) appears to be the broadest definition that would be supported by the original disclosure since, for instance, no examples are disclosed containing three heteroatoms (as permitted by interpretation (1)), no examples are disclosed lacking a nitrogen heteroatom (as permitted by interpretations (3) and (4)). Dependent claims 2, 3, 6, 8-11, 14, 15, 17 and 25-31 are rejected as indefinite for the same reason and where claim 3 only further complicates the issue since it omits “nitrogen-containing” from the generic limitation. It is suggested that Applicant amend claim 1 to conform to interpretation (2) to avoid introducing new matter. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the definition of R5 and R16 ring formation in claim 1 recites the broad recitation “substituted with one, two, three, four or five groups”, and the claim also recites “selected from one, two, three, or four groups” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Dependent claims 2-4, 6, 8, 9, 14, 15, 17 and 25-31 are rejected as indefinite for the same reason. Claim 10 is rejected as indefinite since the fourth option contains the variables Rc and Rd that are not defined in either claim 10 or parent claim 1. Claim Rejections - 35 USC § 112(d) The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 1 and 3 are rejected as indefinite based on the definition of “A;” however, since claim 3 no longer requires that “A” be “nitrogen-containing” and at least one interpretation of claim 1 is that A must contain nitrogen, claim 3 fails to further limit its parent claim under at least one claim construction of parent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 provides for the fifth, sixth and eleventh options to be substituted by -CH2CN, which is not embraced by parent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. It is suggested that Applicant convert claim 4 to independent form to avoid introducing new matter by broadening claim 1. Claim 10 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The options for the various rings to be substituted by C1-C3alkoxyC1-C3alkyl and benzyl do not fall within the scope of parent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. It is suggested that Applicant amend claim 10 to independent form to avoid introducing new matter by broadening claim 1 or delete the noted options. Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 11 recites that R5 is –(C1-C3alkyl)-R6 where R6 can be an eight- or nine-membered bicyclic fused saturated ring system or a ten-membered tricyclic saturated ring system wherein these options optionally contain a nitrogen atom. Parent claim 1 only provides for R5 to be up to C6 cycloalkyl in the option C3-C6cyclolalkylC1-C6alkyl. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Allowable Subject Matter Claim 23 is allowed. The Examiner generally agrees with the ISR regarding the closest prior art documents; however, the Examiner finds that the discussion for inventive step does not translate to a case for obviousness under U.S. practice. While, for instance, WO 2021/129824 A1 is generic to compounds having a halogen moiety at the instantly recited R’ position, the prior art fails to reasonably suggest why one of the subset of compounds having a heteroaryl group corresponding to the instant variable R4 should be chosen for modification and particularly modified to contain a halogen at the instantly claimed R’ position relative to the myriad additional modifications that could conceivably be made within the genus of the prior art. Even combining additional references (such as U.S. Patent PGPub No. 2019/0144444 A1) that disclose compounds having a halogen at the α-position of an α,β-unsaturated carbonyl, the corresponding compounds (and the majority of exemplary compounds) do not contain a heteroaryl group corresponding to R4. Any case for obviousness therefore would rely strongly on improper hindsight bias to navigate the prior art generic structures to arrive at any compounds instantly claimed. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST. 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, Renee Claytor can be reached at 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
Read full office action

Prosecution Timeline

Dec 09, 2024
Application Filed
Sep 10, 2026
Non-Final Rejection mailed — §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12747248
PROCESSES FOR THE PREPARATION OF SUBSTITUTED SPIROOXINDOLE DERIVATIVES
3y 6m to grant Granted Sep 29, 2026
Patent 12698277
2-polysubstituted aromatic ring-pyrimidine derivatives, preparation and medical application thereof
3y 6m to grant Granted Aug 04, 2026
Patent 12698291
PIKFYVE KINASE INHIBITORS
2y 4m to grant Granted Aug 04, 2026
Patent 12668588
METHOD FOR PREPARING INTERMEDIATE OF URACIL COMPOUND CONTAINING ISOXAZOLINE
3y 5m to grant Granted Jun 30, 2026
Patent 12653806
METHODS FOR TREATING COVID-19
3y 2m to grant Granted Jun 16, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

Get a prosecution strategy drawn from examiner precedents, rejection analysis, and claim mapping.
Typically takes 5-10 seconds — AI-generated, attorney review required before filing

Prosecution Projections

1-2
Expected OA Rounds
71%
Grant Probability
84%
With Interview (+12.4%)
2y 5m (~7m remaining)
Median Time to Grant
Low
PTA Risk
Based on 999 resolved cases by this examiner. Grant probability derived from career allowance rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month