Prosecution Insights
Last updated: July 17, 2026
Application No. 18/564,512

QUINOLINAMINE COMPOUND, PREPARATION METHOD THEREFOR AND APPLICATION THEREOF IN PHARMACEUTICALS

Non-Final OA §103
Filed
Nov 27, 2023
Priority
May 27, 2021 — CN 202110606803.1 +2 more
Examiner
LAU, JONATHAN S
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shanghai Hengrui Pharmaceutical Co., Ltd.
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
4m
Est. Remaining
46%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allowance Rate
667 granted / 1043 resolved
+4.0% vs TC avg
Minimal -18% lift
Without
With
+-18.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
50 currently pending
Career history
1080
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
58.1%
+18.1% vs TC avg
§102
7.7%
-32.3% vs TC avg
§112
7.9%
-32.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1043 resolved cases

Office Action

§103
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 . This application is the national stage entry of PCT/CN2022/095441, filed 27 May 2022; claims benefit of foreign priority document CHINA 202110606803.1, filed 27 May 2021; and claims benefit of foreign priority document CHINA 202110976020.2, filed 24 Aug 2021. These foreign priority documents are not in English. Claims 1-5, 7, 9, 11, 13, 17-25, and 27-28 are pending in the current application. Claims 20-21, 23-25, and 27-28, drawn to non-elected inventions, are withdrawn. Claims 1-5, 7, 9, 11, 13, 17-19, and 22 are examined on the merits herein. Election/Restrictions Applicant's election with traverse of Group I, claims 1-5, 7, 9, 11, 13, 17-19, and 22, in the reply filed on 08 May 2026 is acknowledged. The traversal is on the ground(s) that the special technical feature showing unity of invention is the intended use of the claimed compound as an miRNA-regulating compound. As an initial matter, this is not found persuasive because with regard the claimed compound the subject matter that is claimed is the compound itself, not the intended use of the compound. Therefore the common feature between the inventions is the compound having a particular structure, and as detailed in the Restriction Requirement this compound having a particular structure is not inventive over the teachings of the prior art, showing lack of unity of invention between the different groups of inventions. As a second matter, this is not found persuasive because this limitation is not required of the compound of general formula (I), as there is no explicitly recited functional limitation which would structurally limit general formula (I) to those compounds which possess such functional property. Therefore this unclaimed feature cannot serve as the special technical feature showing unity of invention based on the invention as claimed. The requirement is still deemed proper and is therefore made FINAL. Claims 20-21 and 23-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 08 May 2026. Applicant’s election of species of compound 1 in the reply filed on 08 May 2026 is acknowledged. However, upon reconsideration after search and examination of the relevant prior art, the election of species requirement is withdrawn. The full scope of the compound of general formula (I) is examined herein. 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1-3, 7, 9, 11, 13, 17, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over JP’251 (JP 2011026251 A, published 10 Feb 2011, provided by Applicant in IDS filed 27 Nov 2023, EPO English machine translation cited in PTO-892). JP’251 teaches a 2-arylaminoquinoline compound as the active ingredient of an erythropoietin production promoter (EPO translation, page 1, paragraph 1). The compound is of general formula PNG media_image1.png 186 302 media_image1.png Greyscale (page 8, paragraph 26-27) where R1 represents a hydrogen atom or a C1-6 alkyl group, and R2, R3, R4, R5, and R6 may be the same or different; a hydrogen atom, a halogen atom, a C1-6 alkyl group, C1 -6 alkoxy group, amino group or hydroxyl group, R7, R8 and R9 may be the same or different and each represents a hydrogen atom, halogen atom, C1-6 alkyl group, halo C1-6 alkyl group, C1-6 alkoxy A group, a halo C1-6 alkoxy group, a C1-6 alkylamino group, a diC1-6 alkylamino group, a C2-7 alkoxycarbonyl group, a C2-7 alkanoylamino group, a nitro group or a morpholino group, or R7, R8 together may form a C3-4 alkylene group, a C1-3 alkylenedioxy group or a benzene ring, R10 represents a hydrogen atom or a C1-6 alkyl group, and X represents a methine group or represents a nitrogen atom (EPO translation, paragraph spanning pages 3-4). Embodiments of the compound include 39 PNG media_image2.png 72 128 media_image2.png Greyscale and 49 PNG media_image3.png 58 128 media_image3.png Greyscale (pages 18 and 19). JP’251 further teaches embodiments wherein a substituent R2, R3, R4, R5, and R6 is the halogen Cl such as compound 18 (page 16). JP’251 teaches general methods of making the compound having different substituent groups (EPO translation, pages 8-10). The compound may be formulated as a pharmaceutical composition (EPO translation, page 11, paragraphs 2-7), addressing limitations of claim 22. JP’251 does not specifically disclose a compound of claimed general formula (I) (claim 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teaching of JP’251 to select from within the general formula to arrive at a compound having the structure as claimed. One of ordinary skill in the art would have been motivated to modify JP’251 with a reasonable expectation of success because JP’251 teaches the general formula of the compound and provide guidance for picking-and-choosing from within the scope of this general formula in the form of the disclosed embodiments, such as compounds 39 and 49. In this case the compounds 39 and 49 provide guidance for selecting the compound corresponding to claimed general formula (I) wherein one R3 is alkyl Me, R2 is H if present, G is CH, and A is either a 5-membered cycloalkyl or heterocycyl ring. Further guidance for picking-and-choosing a substituent to be the halogen Cl is provided such as compound 18, making obvious claimed compounds 4 and 10 recited in claim 17. Regarding claim 11, JP’251 teaches R7 and R8 together may form a C3-4 alkylene group or a C1-3 alkylenedioxy group, which in view of the compounds 39 (C1 alkylenedioxy group) and 49 (C3 alkylene group) provides guidance for selecting the compound corresponding to claimed general formula (I) wherein A is either a 6-membered cycloalkyl (C4 alkylene group) or heterocycyl (C2 alkylenedioxy group) ring. Response to Applicant’s Remarks: Applicant’s remarks, filed 08 May 2026, have been fully considered and not found to be persuasive. In response to applicant's argument in the response to the restriction that the claimed compound possesses the function as an miRNA-regulating compound, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the rejection above JP’251 is cited to provide guidance for a compound having the same structural features the claimed compound and possessing the different function of an erythropoietin production promoter. Even if made for a different intended function, the suggestions of the prior art make obvious a compound having the same structure as the claimed compound. Further, while MPEP 716.02(a) provides at III. “Presence of a property not possessed by the prior art is evidence of nonobviousness. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)” and at II. ““Evidence that a compound is unexpectedly superior in one of a spectrum of common properties . . . can be enough to rebut a prima facie case of obviousness.” No set number of examples of superiority is required. In re Chupp, 816 F.2d 643, 646, 2 USPQ2d 1437, 1439 (Fed. Cir. 1987)”, in this case the record is not clear how the claimed compound(s) compare to either of the closest prior art embodiments of JP’251 compound 39 and 49. Therefore it is not clear on the record that the property of the claimed compound is not possessed by or is superior to the closest prior art embodiments. Allowable Subject Matter Claims 4-5 and 18-19 are 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. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is JP’251 (JP 2011026251 A, published 10 Feb 2011, provided by Applicant in IDS filed 27 Nov 2023) as detailed above. JP’251 does not teaches the compound having the all limitations including those incorporated by claim dependency of any of claims 4-5 or 18-19. Other relevant prior art is as follows: KONO et al. (WO 2000/15645 A1, published 10 Sept 1999, cited in PTO-892, EPO English machine translation included), discloses a phosphonic acid ester derivative and a production method thereof (abstract). KONO et al. discloses the production method comprising reacting the starting material of formulas (3) and (4) (page 8, reaction scheme at top of page). KONO et al. discloses embodiments of the starting material of formula (4) PNG media_image4.png 46 170 media_image4.png Greyscale of compound 88 PNG media_image5.png 46 268 media_image5.png Greyscale (table 1 at page 15). This embodiment different from claimed formula (I) in that 1 to 4 of the groups R3 are hydrogen. Campos et al. (Synthesis, 2020, 52, p3071-3076, cited in PTO-892) discloses synthesis of a new library of polyheterocyclic 11H-pyrido[2,1-b]quinazolin-11-one derivatives (page 3071, abstract). Campos et al. discloses an unsuccessful synthesis resulted in the noncyclized compound 7c and 7d, where 7c is PNG media_image6.png 142 184 media_image6.png Greyscale (page 3074, left column, Scheme 8). Compound 7c differs from claimed formula (I) in that 1 to 4 of the groups R3 are hydrogen, and R2 is a carboxylate ester. Esposito et al. (WO 2021/151062 A1, filed 25 Jan 2021, provided by Applicant in IDS filed 27 Nov 2023) discloses novel heterocyclic compounds (abstract). Esposito et al. discloses embodiments such as compounds 86-90 PNG media_image7.png 194 426 media_image7.png Greyscale (page 61). The compounds disclosed in Esposito et al. differ from claimed formula (I) in that at least one R1 is oxo (=O). Conclusion No claim is currently in condition for allowance. Claims 4-5 and 18-19 are objected to as being dependent upon a rejected base claim. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern. 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, Scarlett Goon can be reached at (571)270-5241. 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. /JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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Prosecution Timeline

Nov 27, 2023
Application Filed
Jun 16, 2026
Non-Final Rejection mailed — §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
64%
Grant Probability
46%
With Interview (-18.4%)
3y 0m (~4m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1043 resolved cases by this examiner. Grant probability derived from career allowance rate.

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