Prosecution Insights
Last updated: April 19, 2026
Application No. 18/282,082

QUINAZOLINE-BASED COMPOUND, COMPOSITION, AND APPLICATION OF QUINAZOLINE-BASED COMPOUND

Non-Final OA §103§112
Filed
Sep 14, 2023
Examiner
LEE, CHIHYI NMN
Art Unit
1628
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
BEIJING SCITECH-MQ PHARMACEUTICALS LIMITED
OA Round
1 (Non-Final)
34%
Grant Probability
At Risk
1-2
OA Rounds
3y 2m
To Grant
99%
With Interview

Examiner Intelligence

Grants only 34% of cases
34%
Career Allow Rate
26 granted / 77 resolved
-26.2% vs TC avg
Strong +65% interview lift
Without
With
+65.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
57 currently pending
Career history
134
Total Applications
across all art units

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
35.3%
-4.7% vs TC avg
§102
14.2%
-25.8% vs TC avg
§112
28.5%
-11.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 77 resolved cases

Office Action

§103 §112
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. Election/Restrictions Applicant's election with traverse of Group I , claims 1-12, drawn to a compound represented by formula (I), a stereoisomer thereof, a pharmaceutically acceptable salt thereof, or a deuterated derivative thereof, and a pharmaceutical composition; and the compound having the structure of: as the elected species of compound represented by formula (I) in the reply filed on March 12, 2026 is acknowledged. The traversal is on the ground(s) that the compound species taught by Zhang and Xia et al. have a substituent at the 7-position whereas the claimed invention has a substituent at the 5-position; and even the formula I taught by Zhang et al. describes the 5-position substituents, it is too board to teach the claimed invention, thus, one would have no motivation to arrive at the claimed invention with unexpected results. This is not found persuasive because applicant clearly noted that the 5-position substituent (s) of the claimed invention are taught by the formula I of Zhang et al. As noted in the previous Office Action mailed on January 12, 2026, it is evident that the technical feature of a compound represented by formula (I) shared between the groups of inventions and among the groups of species are not considered a special technical feature in view of Zhang and Xia et al ., respectivel y. It is noted that an obviousness-type rejection is not a standard to break unity of invention, thus, motivation and/or reasonable expectation of success is not required to determine whether the shared (or corresponding) technical feature is lacking unity. The requirement is still deemed proper and is therefore made FINAL. Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 12, 2026. Status of Claims Claims 1-15 are pending. Claims 13-15 are withdrawn. Claims 1-12 are under examination in accordance with the elected species. Priority The instant application 18 / 282 , 082 filed on September 14, 2023 is a 371 of PCT/CN2022/081599 filed on March 18, 2022, which claims priority to, and the benefits of Foreign Application No. CN202110296394.X filed on March 19, 2021. Information Disclosure Statement The information disclosure statement s (IDS) submitted on 12/13/2023, 9/23/2024 and 4/15/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement s are being considered by the examiner. Claim Objections Claim s 1 , 3-4 and 7 are objected to because of the following informalities: Regarding claim 1, the recitation of “R a and R b ” and “the 4- to 7-membered heteroalicyclic group” shown below: should appear after the term --wherein—to indicate that R a , R b and 4- to 7-membered heteroalicyclic group are referring back to the previously recited R a , R b and 4- to 7-membered heteroalicyclic group in R 1 . For example, --wherein R a and R b are each independently--. In addition, the recitation of “R 5 ” and “the 4-to 6-membered heteroalicyclic group” shown below: should appear after the term --wherein— in order to indicate that R 5 is referring back to the previously recited R 5 in R 2 ; and to indicate 4- to 7-membered heteroalicyclic group is referring to the 4- to 7-membered heteroalicyclic group in R 5 . Same logic applies to the recitation of “R’, R” are each independently H or C 1 -C 3 alkyl” and should read -- R’ and R” are each independently H or C 1 -C 3 alkyl --, the comma should be replaced by the coordinating conjunction –and —in order to indicate both R’ and R" are independently selected from the claimed group. Regarding claim 3, the recitation of “R a and R b ” and “the 4- to 6-membered heteroalicyclic group” should appear after the term --wherein—to indicate that R a , R b and 4- to 7-membered heteroalicyclic group are referring back to the previously recited R a , R b and 4- to 7-membered heteroalicyclic group in R 1 . For example, —wherein R a and R b are each independently--. Regarding claim s 4 and 7 , the recitation of “R 5 ” and “ the 4-to 6-membered heteroalicyclic group” should appear after the term —wherein— in order to indicate that R 5 is referring back to the previously recited R 5 in R 2 ; and to indicate 4- to 7-membered heteroalicyclic group is referring to the 4- to 7-membered heteroalicyclic group in R 5 . Appropriate correction is required. 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 appl icant regards as his invention. Claim s 3 - 6 and 8 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. Regarding claim 3 - 6 and 8 , 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, claim 3 recites the broad recitation “ T 1 is –(CH 2 ) n -, wherein n is an integer from 0 to 2 … ” , and the claim also recites “ T 1 is –(CH 2 ) n -, wherein n is an integer from 0 to 1…” which is the narrower statement of the range/limitation; claim 4 recites the broad recitation “wherein L is -O- or -NH-…” , and the claim also recites “L is -O-…” which is the narrower statement of the range/limitation; claim 5 recites the broad recitation “T 2 is -O-(CH 2 )p-, wherein p is 0 or 1…”, and the claim also recites “T 2 is -O-(CH 2 )p, wherein p is 1…” which is the narrower statement of the range/limitation ; claim 6 recites the broad recitation “R 4 is hydrogen, fluorine, chlorine, methyl or methoxy”, and the claim also recites “R 4 is hydrogen, fluorine, or chlorine” which is the narrower statement of the range/limitation ; and claim 8 recites the broad recitation “R 4 is fluorine or chlorine”, and the claim also recites “R 4 is chlorine” 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. 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. Claim s 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (CN 101824029 A) . Please note Zhang et al. is in written in Chinese and a machine translation has been provided, the specific portions cited in this instant office action will refer to the sections of the machine translation. Zhang et al. teaches a compound having the structure of: , wherein R 6 is methoxy (referred to herein as Compound 1 ) is an exemplary tyrosine kinase irreversible inhibitor of general formula (I) (see e.g., claims 1 and 7). Zhang et al. further teaches a drug composition for the treatment or prevention of cell proliferation disorders, including therapeutic effective amounts of the above-mentioned tyrosine kinase irreversible inhibitors and pharmaceutically available carriers (see e.g., p. 10 , line 12-15 of machine translation). Zhang et al. further teaches the tyrosine kinase irreversible inhibitors of general formula (I) : , wherein R 7 is H or C 1-6 alkyl groups (see e.g., claim 1). Zhang et al. further teaches C 1-6 alkyl groups represent linear or branched-chain alkyl groups , such as methyl or ethyl (see e.g., p. 12 , last 2 lines). Zhang et al. further teaches the compound can be combined with conventional cancer treatments such as chemotherapy or radiotherapy (see e.g., p. 11 , line 26-27). Zhang et al. does not teach the elected species of compound represented by formula (I). According to MPEP 2144.09, “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. ‘ An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties. ’ In re Payne , 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch , 315 F.2d 381, 137 USPQ 43 (CCPA 1963) ” . According to MPEP 2144.09 (II) and (III), ”[c] ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder , 563 F.2d 457, 195 USPQ 426 (CCPA 1977) … Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne , 606 F.2d 303, 203 USPQ 245 (CCPA 1979)”. In the present case, the difference between the compound 1 of Zhang et al. and the elected compound species instantly claimed is that the prior art compound has methyl at R 7 rather than ethyl, and the methoxy is at the 7-position rather than 5-position of the quinazoline ring ( ) shown below (see shaded): . It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by select ing compound 1 of Zhang et al., and then modify said compound by substituting methyl with ethyl as C 1-6 alkyl groups at R 7 , and then make the instantly claimed derivatives by changing the point of attachment for the methoxy . The claimed compound and the prior art compound are common derivatives known as isomers. One would have been motivated to do so, because Zhang et al. teaches methyl and ethyl can be interchanged as the C 1-6 alkyl groups at R 7 to arrive at a tyrosine kinase irreversible inhibitor . One would have also been motivated to do so in order to prepare similar compounds that are pharmacologically active compounds useful for inhibiting tyrosine kinase. O ne would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the position isomer s (compounds having the same radicals in physically different positions on the same nucleus) of the modified compound 1 of Zhang et al. , which substitutes methyl with ethyl at R 7 , would have exerted the same or substantially similar tyrosine kinase irreversible inhibit ing affect ; and therefore, said modified compound 1 can successfully be combine with a pharmaceutically acceptable carrier to arrive at a drug composition. Please note the fact that Zhang et al. teaches racemic mixture of compound 1 , it renders obvious the limitation of “ ” recites in claim 10. Regarding the limitation of “wherein the pharmaceutical composition also contains one or more other therapeutic agents” in claim 12 , it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the drug composition set forth above by combining said drug composition with a chemotherapy as the conventional cancer treatments . One would have been motivated to do so, because Zhang et al. teaches the tyrosine kinase irreversible inhibitor can be combined with conventional cancer treatments , such as chemotherapy . One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the drug composition comprising the modified compound 1 of Zhang et al. set forth above and a pharmaceutically acceptable carrier and chemotherapy can successfully be combined without any appreciable loss of activity, and that renders obvious the limitation of “contains one or more other therapeutic agents”. Please note the modified compound 1 of Zhang et al. set forth above is a compound represent by instant formula (I): , wherein Z is -NH-; T 1 is –(CH2) 1 -; R 1 is (i.e., 2-ethylpyrrolidin-2-yl) ; L is O; R 2 is -CH 3 ; R 4 is -Cl (i.e., halogen); T 2 is -O-CH 2 -; and R 3 is (i.e., pyridy in-2-yl). Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Chihyi Lee whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0663 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 8:30 am - 5:00 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, FILLIN "SPE Name?" \* MERGEFORMAT Amy L. Clark can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-1310 . 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. /CHIHYI LEE/ Examiner, Art Unit 1628 /JEAN P CORNET/ Primary Examiner, Art Unit 1628
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Prosecution Timeline

Sep 14, 2023
Application Filed
Mar 30, 2026
Non-Final Rejection — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
34%
Grant Probability
99%
With Interview (+65.2%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 77 resolved cases by this examiner. Grant probability derived from career allow rate.

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