Prosecution Insights
Last updated: October 25, 2026
Application No. 18/704,441

5-SUBSTITUTED PYRIDINE-2(1H)-KETONE COMPOUND AND USE THEREOF

Final Rejection §103§112§DP
Filed
Apr 24, 2024
Priority
Oct 29, 2021 — CN 202111272187.7 +2 more
Examiner
MOORE, SUSANNA
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Jiangsu Kanion Pharmaceutical Co. Ltd.
OA Round
2 (Final)
68%
Grant Probability
Favorable
3-4
OA Rounds
4m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allowance Rate
862 granted / 1268 resolved
+8.0% vs TC avg
Strong +32% interview lift
Without
With
+31.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
71 currently pending
Career history
1348
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
17.6%
-22.4% vs TC avg
§102
16.4%
-23.6% vs TC avg
§112
40.3%
+0.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1268 resolved cases

Office Action

§103 §112 §DP
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 is a Final Office Action. Claims 1, 3, 4, 15-24, 26 and 28-31 are pending and under consideration. Claim Objections Claim 1 is objected to because of the following informalities: the term “and” should be inserted after the definition of the variable n. Appropriate correction is required. Claim 16, 17, 23, 24 and 26 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. Claim Rejections - 35 USC § 112 The rejection of claims 19-22 under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for crystal form A, which is not further limiting, is withdrawn based on the amendments. The rejection of claim 23 under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for the “or” is not further limiting, is withdrawn based on the amendments. 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 18-22 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 pre-AIA the applicant regards as the invention. In claims 18-22 the term “comprises” should be replaced with “further comprises” since the peaks are additional peaks. Thus, said claims are vague. 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 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. Claim Rejections - 35 USC § 103 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a). Claims 1, 3, 4, 15 and 28-31 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Xu et al. (WO 2021004467, cited on the IDS). The present application claims a compound of formula (X), wherein T= CH, R1= H, m= 0, A= imidzazo[1,2-a]pyrazine, L= CH2, T1= CH, T2= nitrogen, T3= C(CH3), R2= H, n= 0, R3= H, and p= 0; and the pyridine ring substituted with R3 is substituted with (=O) adjacent to the NH or the tautomer OH: PNG media_image1.png 184 266 media_image1.png Greyscale Xu et al. teach the a compound of formula (X), wherein T= CH, R1= H, m= 0, A= imidzazo[1,2-a]pyrazine, L= CH2, T1= CH, T2= nitrogen, T3= C(CH3), R2= H, n= 0, R3= H, and p= 0; and the pyridine ring substituted with R3 is substituted with (OCH3) adjacent to the nitrogen: PNG media_image2.png 82 871 media_image2.png Greyscale PNG media_image3.png 257 550 media_image3.png Greyscale , see page 63, compound 20. The only difference between two compounds is the OCH3 versus OH. The genus of formula (I) teaches both groups as alternatively useable, see page 3, line 5. The same utility is disclosed as in the present application, see abstract. Thus, said claims are rendered obvious. Applicant traverses by stating, “Compared with Xu et al. (W02021004467), the difference of amended claim 1 lies in the terminal structure of the compound. Specifically, the terminal structure of the compound in amended claim 1 is pyridine PNG media_image4.png 75 81 media_image4.png Greyscale i.e., hydroxyl-substituted pyridine), while the corresponding position in all the specific compounds disclosed by Xu et al (W02021004467) is pyridine PNG media_image5.png 54 69 media_image5.png Greyscale which is not substituted with a hydroxyl group. Pyridine PNG media_image6.png 71 71 media_image6.png Greyscale and pyridone PNG media_image7.png 68 85 media_image7.png Greyscale have significant structural differences, and Xu et al. (W02021004467) provides no teaching or suggestion to make such a modification.” This is not persuasive. As noted in the rejection, the genus of formula (I) in the Xu reference teaches both groups as alternatively useable, see page 3, line 5. Thus, the rejection is maintained. The rejection may be overcome by adding a proviso in the definition of R3, which indicates R3 is substituted on the nitrogen in the lactone ring. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claims 1, 3, 4, 15 and 28-31 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12365686. Although the conflicting claims are not identical, they are not patentably distinct from each other for the same reasons noted in the 103 rejection above. Applicant traverses with the same argument as noted in the 103 rejection above. Thus, the same rationale applied by the Examiner is equally applicable here. Thus, the rejection is maintained. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 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 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. /SUSANNA MOORE/Primary Examiner, Art Unit 1624
Read full office action

Prosecution Timeline

Apr 24, 2024
Application Filed
Apr 28, 2026
Non-Final Rejection mailed — §103, §112, §DP
Jul 15, 2026
Response Filed
Sep 28, 2026
Final Rejection mailed — §103, §112, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12767658
TETRACYCLIC PYRIMIDINONE COMPOUND, PREPARATION METHOD THEREFOR, AND COMPOSITION AND USE THEREOF
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Patent 12760059
GLUCOCORTICOID RECEPTOR MODULATORS
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Patent 12753202
ANDROGEN RECEPTOR MODULATORS
4y 0m to grant Granted Oct 06, 2026
Patent 12735434
FUSED TETRACYCLIC QUINAZOLINE DERIVATIVES AS INHIBITORS OF ERBB2
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Patent 12723043
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3y 6m to grant Granted Sep 01, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
68%
Grant Probability
99%
With Interview (+31.6%)
2y 11m (~4m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1268 resolved cases by this examiner. Grant probability derived from career allowance rate.

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