Prosecution Insights
Last updated: April 19, 2026
Application No. 18/179,838

SOLID FORMS, SALTS, AND PROCESSES OF PREPARATION OF A CDK2 INHIBITOR

Non-Final OA §103§112
Filed
Mar 07, 2023
Examiner
TOWNSLEY, SARA ELIZABETH
Art Unit
1629
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Incyte Corporation
OA Round
1 (Non-Final)
25%
Grant Probability
At Risk
1-2
OA Rounds
4y 0m
To Grant
73%
With Interview

Examiner Intelligence

Grants only 25% of cases
25%
Career Allow Rate
95 granted / 381 resolved
-35.1% vs TC avg
Strong +48% interview lift
Without
With
+48.0%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
50 currently pending
Career history
431
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
40.3%
+0.3% vs TC avg
§102
19.7%
-20.3% vs TC avg
§112
23.5%
-16.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 381 resolved cases

Office Action

§103 §112
NON-FINAL REJECTION This application, filed Mar. 7, 2023, claims benefit of priority to provisional application 63/317,308, filed Mar. 7, 2022. Claims 1-69 are pending. 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 . Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Election/Restrictions Applicant’s election without traverse of Group I, drawn to solid forms and salts of compounds of formula (I), intermediates, and compositions; and the freebase species of the compound of formula (I), PNG media_image1.png 124 235 media_image1.png Greyscale in the reply filed on Nov. 10, 2025 is acknowledged. Claims 18-42 and 44-67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Nov. 10, 2025. Because the elected compound is free of the prior art, search and examination has been extended to the next species. See MPEP § 803.02. Claims 1-17, 43, 68, and 69 are currently pending and under consideration. Information Disclosure Statement The information disclosure statements (IDS) submitted on Jul. 5, 2024, Nov. 10, 2025, and Jan. 13, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Claim Rejections - 35 USC § 112 Claims 6, 8, 9, 12, and 16 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. Specifically, claims 6, 8, and 9 recite the solid form of claim 1, having an XRPD pattern "as substantially shown in FIG. 1"; "as substantially shown in FIG. 2"; and "as substantially shown in FIG. 3," respectively. Claim 12 recites the solid form of claim 10, having an XRPD pattern "as substantially shown in FIG. 22;" and claim 16 recites the solid form of claim 14, having an XRPD pattern "as substantially shown in FIG. 25." However, the claims are to be complete in themselves. As recognized by MPEP § 2173.05(s), incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). Therefore, a claim which refers to an external figure or table renders the metes and bounds of the claim indefinite. Claim Rejections - 35 USC § 103 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 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. Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Van Baak et al. (WO 2006011797, cited on PTO-892). Van Baak et al. claim a recording medium comprising a support and an ink receiving layer adhered to said support, having at least one layer comprising a water soluble polymer and at least one compound according to general formula (II), PNG media_image2.png 358 720 media_image2.png Greyscale (claims 1 and 7). Van Baak et al. differs from claim 68 in that the reference does not exemplify the first compound recited by claim 68 (2,7-dibromo-8-ethoxy-[1,2,4]triazolo[1,5-a]pyridine), having the structural formula, PNG media_image3.png 120 158 media_image3.png Greyscale . However, Van Baak et al. claim the preferred genus of formula (II) (shown above), which encompasses the claimed compound, wherein X1 and X4 are each C; X2 is N; R3 and R6 are halogen, e.g., bromine (see p. 3, line 1); R7 is ethoxy (see p. 2, lines 19-20); and R4 and R5 are each hydrogen. As recognized by MPEP §2144.08, several factors are considered in determining whether a claimed species would have been obvious to one of ordinary skill in the art at the time the invention was made, where the prior art teaches a genus that encompasses the species. In particular, Van Baak et al. define Formula (II) to encompass six possible bicyclic cores, wherein X1, X2, and X4 are each selected from C or N. This core can be optionally substituted up to five times, with R3, R4, R5, R6, or R7, which are selected from eleven small monovalent substituents that include no rings or other moieties that would substantially alter the compound's properties. Notably, the R3-R7 substituents specify C1-C2 alkoxy (methoxy or ethoxy); and examples of halogen are limited to chloro, bromo, and iodo (p. 3, line 1). Thus, Van Baak et al. explicitly point out ethoxy and bromine as suitable substituents. While Formula (II) encompasses more than 20 compounds, one of ordinary skill in the art can readily envisage each member of the genus. In re Petering, 301 F.2d 676, 681, 133 USPQ 275, 280 (CCPA 1962). Further, the compounds of Van Baak et al. are all disclosed as additives for use in inkjet recording media to improve beading behavior, cracking, and curling as a result of low humidity (p. 1, lines 22-28; p. 5, lines 9-15); and Formula (II) is disclosed as a preferred genus of compounds possessing these properties (p. 2, line 14 to p. 3, line 2). Against these teachings of the prior art, the instant specification discloses the claimed compound only as an intermediate (specification p. 126, Intermediate 7, Example 4); and presents no evidence of secondary consider-ations. Therefore, it would have been prima facie obvious to one of ordinary skill in the chemical arts as of the filing date to select and prepare the first compound recited by claim 68 (2,7-dibromo-8-ethoxy-[1,2,4]triazolo[1,5-a]pyridine) with a reasonable expectation of success, because the claimed compound, falling squarely within the scope of Formula (II), would be expected to function to improve inkjet recording media, as taught by Van Baak et al. Obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). Allowable Subject Matter Claims 1-5, 7, 10, 11, 13-15, 17, 43, and 69 are allowed. Conclusion Claims 6, 8, 9, 12, 16, and 68 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/ external/portal. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629
Read full office action

Prosecution Timeline

Mar 07, 2023
Application Filed
Jan 20, 2026
Non-Final Rejection — §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12600738
QUINOLINONE DERIVATIVE COMPOUND SELECTIVELY BINDING TO CYSTEINE, PEPTIDE CONJUGATE THEREOF, AND ANTIBODY-DRUG CONJUGATE COMPRISING SAME
2y 5m to grant Granted Apr 14, 2026
Patent 12582633
METHODS OF TREATING SEVERE ACUTE RESPIRATORY SYNDROME
2y 5m to grant Granted Mar 24, 2026
Patent 12582639
PREVENTIVE, RELIEF OR THERAPEUTIC USE OF 2,3,5-SUBSTITUTED THIOPHENE COMPOUND AGAINST GASTROINTESTINAL STROMAL TUMOR
2y 5m to grant Granted Mar 24, 2026
Patent 12570663
CRYSTAL FORMS OF AN ANTI-SARS COV-2 AGENT
2y 5m to grant Granted Mar 10, 2026
Patent 12552774
METHOD FOR PREPARING PYROTINIB
2y 5m to grant Granted Feb 17, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
25%
Grant Probability
73%
With Interview (+48.0%)
4y 0m
Median Time to Grant
Low
PTA Risk
Based on 381 resolved cases by this examiner. Grant probability derived from career allow 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