Prosecution Insights
Last updated: May 29, 2026
Application No. 18/546,850

METHOD FOR MANUFACTURING AZOLE DERIVATIVE

Final Rejection §112§DOUBLEPATENT
Filed
Aug 17, 2023
Priority
Feb 22, 2021 — JP 2021-026670 +1 more
Examiner
SEITZ, ANTHONY JOSEPH
Art Unit
1629
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Kureha Corporation
OA Round
2 (Final)
69%
Grant Probability
Favorable
3-4
OA Rounds
7m
Est. Remaining
97%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allowance Rate
117 granted / 170 resolved
+8.8% vs TC avg
Strong +28% interview lift
Without
With
+28.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
68 currently pending
Career history
240
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
36.4%
-3.6% vs TC avg
§102
14.2%
-25.8% vs TC avg
§112
7.7%
-32.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 170 resolved cases

Office Action

§112 §DOUBLEPATENT
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 . DETAILED ACTION Status of the Claims Claims 1-4 are pending and are examined on their merits. Information Disclosure Statement The Information Disclosure Statement filed on March 17th 2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action. Claim Rejections - 35 USC § 112(b) 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. Claim 1 is 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. Claim 1 recites the limitation "a reaction system" in reference to the reaction described earlier in the claim. There is insufficient antecedent basis for this limitation in the claim. 35 U.S.C. § 103 Rejections Maintained 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 rejection of claims 1-4 under 35 U.S.C. 103 as being unpatentable over Harigae (U.S. Patent No. 10,945,434 issued on March 16th 2021, effectively filed on November 13th 2017) in view of Veinberg (U.S. Patent No. 5,484,936 issued on January 16th 1996) is maintained. Applicant’s arguments in the response filed on March 4th 2026 are acknowledged. Applicant argues that the amended claim differs from the combination of Harigae and Veinberg in that it necessitates the addition of acid AFTER the addition of the 4-amino-1,2,4-triazole, and that this ordering of steps gives an unexpectedly higher yield. As a preliminary matter, the amended claim as written necessitates that “an acid is added after 4-amino-1,2,4-triazole is dissolved in a solvent of a reaction system.” Veinberg teaches the addition of hydrochloric acid after the 4-amino-1,2,4-triazole is dissolved in solution (Veinberg, col. 6-7, Examples 2-3). Therefore, the combination of Harigae and Veinberg still meets the limitations of the claim. Regarding applicant’s claim of unexpected results, the claim is supported by two examples in applicant’s remarks. One example purports a quantitative yield of 66% by following the combination of Harigae and Veinberg, and the other of which yields 90% by following applicant’s described method. Regarding this claim of unexpected results, it is unclear that this change in yield is dependent on only the reversal of steps that was performed by applicant (a reversal that is commonly considered prima facie obvious; see MPEP 2144.04(IV)(C)). Even for similar reactions, the yield can vary dramatically, as demonstrated in Harigae (See Harigae, Synthesis Example 6 which yields 94.6% and Harigae, Synthesis Example 14 which yields 40.6%). A single instance of an improvement of yield is not sufficient evidence that the reaction provides greater yield in general. Thus applicant’s claim of unexpected results is considered not substantiated and the 103 rejections are maintained. 35 U.S.C. § 103 Rejections Reiterated Claim 1 is directed towards a method for producing a compound of formula (I): PNG media_image1.png 126 206 media_image1.png Greyscale comprising: PNG media_image2.png 216 537 media_image2.png Greyscale PNG media_image3.png 274 532 media_image3.png Greyscale . Harigae teaches a method of producing the compound of formula (I) comprising the step of: PNG media_image4.png 273 353 media_image4.png Greyscale (Harigae, col. 29). Harigae does not teach the intermediate step of reacting the oxirane with the 4-amino-1,2,4-triazole under an acidic condition and deaminating to form the azole product. However, one of ordinary skill in the art would have a reasonable expectation of success in performing this additional intermediate step, because it is known in the art of azole preparation. See Veinberg: PNG media_image5.png 304 298 media_image5.png Greyscale PNG media_image6.png 310 300 media_image6.png Greyscale PNG media_image7.png 100 295 media_image7.png Greyscale (Veinberg, col. 8-9, claim 1). As one of ordinary skill in the art would have a reasonable expectation of success in preparing the compound of Formula (I) using Harigae’s method with the additional taught by Veinberg, claim 1 is prima facie obvious. Claim 2 requires that the acidic condition of claim 1 is formed by containing an alkylsulfonic acid or arylsulfonic acid. Veinberg teaches methanesulfonic acid as the acid present (Veinberg, col. 9, claim 5), and claim 2 is prima facie obvious. Claim 3 requires that in the method of claim 1, the deamination is performed by adding an alkali metal nitrite and an acid to a reaction solution containing the compound of formula (Ia). Veinberg teaches the deamination via addition of sodium nitrite (Veinberg, col. 6). Claim 4 requires that the method of claim 1 comprises a step of crystallizing the product without performing hot filtration. Veinberg teaches crystallization of the product and does not describe hot filtration (Veinberg, col. 6-7), and claim 4 is thereby prima facie obvious. Nonstatutory Double Patenting Rejections Maintained As the arguments regarding the nonstatutory double patenting rejections are identical to those relating to the above 103 rejections, the nonstatutory double patenting rejections are maintained for the same reasons. Nonstatutory Double Patenting Rejections Maintained 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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,945,434 in view of Veinberg (U.S. Patent No. 5,484,936). For the teachings of U.S. Patent No. 10,945,434 and Veinberg as they are relevant to the claims, see the above 103 rejections for claims 1-4. Conclusion THIS ACTION IS MADE FINAL. 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 Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F. 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 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 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. /A.J.S./Examiner, Art Unit 1629 /JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Read full office action

Prosecution Timeline

Aug 17, 2023
Application Filed
Dec 05, 2025
Non-Final Rejection mailed — §112, §DOUBLEPATENT
Mar 04, 2026
Response Filed
Mar 17, 2026
Response after Non-Final Action
Apr 01, 2026
Final Rejection mailed — §112, §DOUBLEPATENT (current)

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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
69%
Grant Probability
97%
With Interview (+28.3%)
3y 5m (~7m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 170 resolved cases by this examiner. Grant probability derived from career allowance rate.

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