Prosecution Insights
Last updated: October 02, 2026
Application No. 18/576,593

PROCESS FOR MAKING DIARYL ISOXAZOLINE DERIVATIVE

Final Rejection §112§DP
Filed
Jan 04, 2024
Priority
Aug 11, 2021 — provisional 63/231,858 +2 more
Examiner
BARBER, KIMBERLY
Art Unit
1615
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Elanco US Inc.
OA Round
2 (Final)
74%
Grant Probability
Favorable
3-4
OA Rounds
3m
Est. Remaining
92%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allowance Rate
53 granted / 72 resolved
+13.6% vs TC avg
Strong +18% interview lift
Without
With
+18.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
33 currently pending
Career history
104
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
69.6%
+29.6% vs TC avg
§102
5.3%
-34.7% vs TC avg
§112
16.8%
-23.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 72 resolved cases

Office Action

§112 §DP
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after January 04, 2024, is being examined under the first inventor to file provisions of the AIA . Status of the Application Receipt is acknowledged of Applicants’ claimed invention filed on 01/04/2024 in the matter of Application N° 18/576,593. Said documents are entered on the record. Claims 1-13 represent all claims currently under consideration. Claims 1-13 are pending in the application. Claims 1, 4-7, and 10 are amended. 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 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 AlA. 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 |.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 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, and 6-11 of copending Application No. 18/006,277 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap. PNG media_image1.png 251 747 media_image1.png Greyscale By reacting a compound of formula (2) with Hydroxylamine PNG media_image2.png 152 416 media_image2.png Greyscale Wherein X is selected from the group consisting of halogen and -C(O)OR4 wherein R4 is a C1-C4 alkyl and appropriate base and a compound of formula (3) PNG media_image3.png 202 340 media_image3.png Greyscale As a result, the claims made in the current application are overlapping. Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10, 11, 12, 13, and 14, of U.S. patent No. 18/978,995. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in question overlap, therefore even while they are not identical, they are not patentably distinct from one another. The copending application’s method involves reacting the compound of formula (2), where X is the compound of formula (3), with a hydroxylamine to create a compound that falls under the purview of the claimed compounds. The copending application’s claims fall under the purview of the current application’s claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented. Response to Arguments Applicant's arguments filed 03/24/2026 have been fully considered but they are not persuasive. Applicant states that additional time is needed to file a terminal disclaimer. However, no terminal disclaimer has been submitted. Therefore, the provisional nonstatutory obviousness-type double patenting rejection of claims 1-11 over claims 1-4 and 6-11 of copending Application No. 18/006,277 is maintained and is not withdrawn. Likewise, the nonstatutory obviousness-type double patenting rejection of claims 1-11 over claims 1-8 and 10-14 of U.S. patent Application No.18/978,995 has not been overcome and is therefore maintained. Applicant’s amendments and/or clarifications to the claim language have overcome the rejection of claims 1 and 5-7 under 35 U.S.C. 112(b). Accordingly, the rejection under 35 U.S.C. 112(b) is acknowledged as resolved and is withdrawn. 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 Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. 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 Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. 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. /KIMBERLY BARBER/Examiner, Art Unit 1615 /Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Read full office action

Prosecution Timeline

Jan 04, 2024
Application Filed
Dec 29, 2025
Non-Final Rejection mailed — §112, §DP
Mar 24, 2026
Response Filed
Jul 10, 2026
Applicant Interview (Telephonic)
Jul 17, 2026
Final Rejection mailed — §112, §DP (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
74%
Grant Probability
92%
With Interview (+18.5%)
3y 0m (~3m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 72 resolved cases by this examiner. Grant probability derived from career allowance rate.

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