Prosecution Insights
Last updated: April 19, 2026
Application No. 18/554,426

UBIQUITIN-SPECIFIC PROTEASE 1 (USP1) INHIBITOR

Non-Final OA §102§112
Filed
Oct 06, 2023
Examiner
HABTE, KAHSAY
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Simcere Zaiming Pharmaceutical Co. Ltd.
OA Round
1 (Non-Final)
85%
Grant Probability
Favorable
1-2
OA Rounds
1y 11m
To Grant
93%
With Interview

Examiner Intelligence

Grants 85% — above average
85%
Career Allow Rate
1348 granted / 1589 resolved
+24.8% vs TC avg
Moderate +8% lift
Without
With
+8.1%
Interview Lift
resolved cases with interview
Fast prosecutor
1y 11m
Avg Prosecution
45 currently pending
Career history
1634
Total Applications
across all art units

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
6.9%
-33.1% vs TC avg
§102
18.9%
-21.1% vs TC avg
§112
47.0%
+7.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1589 resolved cases

Office Action

§102 §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 . Claims 1-19 are pending in this application. Improper Markush Claims 1-14 and 16-19 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117. The Markush grouping of wherein X1 = C; and X3-X4 = S, SO or SO2; and X5 = N and O is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The bicyclic ring can be any number of core bicyclic ring systems with only X2 set as N. They are certainly not enabled for all the different ring systems. . To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. 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)(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. Claims 1-13 and 16-19 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Berry et al. WO 2022216820 A1 (equivalent to US 2024/0239808 A1 that claims benefit to a provisional application 63/171,796, filed on 04/07/2021). Cited reference teaches the following exemplary compounds (anticancer) that are the same as applicants when applicants compound of formula (I) has the following substituents: Ring A = substituted phenyl or substituted pyridyl; Ring B = phenyl; Ring C = substituted imidazole; R1 = R2 = H; X1 = X2 = N; X3 = C, N or O; and X4 = X5 = C(R4)(R5) wherein R4 and R5 are H, -CH3, -OCH3 or merged to into =O). PNG media_image1.png 558 1428 media_image1.png Greyscale PNG media_image2.png 169 1437 media_image2.png Greyscale PNG media_image3.png 422 905 media_image3.png Greyscale PNG media_image4.png 458 1457 media_image4.png Greyscale PNG media_image5.png 503 1491 media_image5.png Greyscale PNG media_image6.png 494 1384 media_image6.png Greyscale PNG media_image7.png 473 1260 media_image7.png Greyscale PNG media_image8.png 452 1418 media_image8.png Greyscale Since said exemplary compounds are the same as applicants a 102(a)(1)/102(a)(2) rejection is proper. Claim Rejections - 35 USC § 112 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 3, 7-9, 14 and 19 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: a. Regarding claim 14, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). b. Regarding claim 19, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention. See MPEP § 2173.05(d). Claims 3, 7-9, 14 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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. Evidence that claims 3, 7-9, 14 and 19 fail(s) to correspond in scope with that which the inventor or a joint inventor, or for pre-AIA applications the applicant regards as the invention. Applicants are reciting a broad definition followed by narrow paragraphs of the same variables in several claims. For example, the definition of Ring A in claim 7 or the definition of R3-R6 in claim 3. PNG media_image9.png 122 657 media_image9.png Greyscale Is this a typographical error? Note that the same problem appears with the chemical structures shown below. PNG media_image10.png 178 605 media_image10.png Greyscale The top three moieties are the same as the lower ones. The same problem appears in claims 3 and 8-9. For example, in claim 3 the definitions of R3-R6 = H, halogen…..is repeated several times. It is unclear why applicants are reciting the same definition again and again. It is recommended that applicants review the definition of said variables and deleted the duplicates. Objection 9. Claim 15 is 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. Information Disclosure Statement 10. Applicant’s Information Disclosure Statement, filed on 08/18/2025 and 01/03/2024 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith. Conclusion 11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM. 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 MURRAY can be reached on 571-272-9023. 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 https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Kahsay Habte/ Primary Examiner, Art Unit 1624
Read full office action

Prosecution Timeline

Oct 06, 2023
Application Filed
Jan 19, 2026
Non-Final Rejection — §102, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12590073
NOVEL PROCESS FOR THE PREPARATION OF MACROCYCLIC CHELANT 2,2',2''-(10-(2-HYDROXYPROPYL)-1,4,7,10-TETRA AZACYCLODODECANE-1,4,7-TRIYL) TRIACETIC ACID AND IT'S COMPLEXES WITH PARAMAGNETIC METAL IONS
2y 5m to grant Granted Mar 31, 2026
Patent 12590067
HERBICIDAL CYCLOHEXANEDIONE DERIVATIVES
2y 5m to grant Granted Mar 31, 2026
Patent 12583866
PYRIDO[2,3-B][1,4]OXAZINES OR TETRAHYDROPYRIDO[2,3-B][1,4]OXAZEPINES AS IAP ANTAGONISTS
2y 5m to grant Granted Mar 24, 2026
Patent 12576040
IONIZABLE LIPIDS AND METHODS OF MANUFACTURE AND USE THEREOF
2y 5m to grant Granted Mar 17, 2026
Patent 12577253
5,6-DIHYDROTHIENO[3,4-H]QUINAZOLINE COMPOUND
2y 5m to grant Granted Mar 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
85%
Grant Probability
93%
With Interview (+8.1%)
1y 11m
Median Time to Grant
Low
PTA Risk
Based on 1589 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