Prosecution Insights
Last updated: April 19, 2026
Application No. 18/199,216

NITROGEN-CONTAINING HETEROCYCLIC COMPOUND AND USE OF SAME

Final Rejection §DP
Filed
May 18, 2023
Examiner
KOSACK, JOSEPH R
Art Unit
3991
Tech Center
3900
Assignee
Takeda Pharmaceutical Company Limited
OA Round
2 (Final)
75%
Grant Probability
Favorable
3-4
OA Rounds
2y 9m
To Grant
69%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allow Rate
962 granted / 1285 resolved
+14.9% vs TC avg
Minimal -6% lift
Without
With
+-5.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
16 currently pending
Career history
1301
Total Applications
across all art units

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
26.2%
-13.8% vs TC avg
§102
24.9%
-15.1% vs TC avg
§112
29.7%
-10.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1285 resolved cases

Office Action

§DP
DETAILED ACTION Claims 18-33 are pending in the present reissue application. Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. 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 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 18-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 18, and 32-37 of U.S. Patent No. RE48,334. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 8 of the ‘334 patent claims compounds of the formula PNG media_image1.png 160 220 media_image1.png Greyscale , where the sum of m and n is 2 or 3 such that ring A is a piperidine ring or a pyrrolidine ring, ring B is an optionally substituted aromatic ring, ring D is a 3,5-bis(trifluoromethyl)phenyl group or a 3,5-dichlorophenyl group, and L is a group represented by the formula PNG media_image2.png 104 446 media_image2.png Greyscale . Present reissue claims 18-27 claim compounds of the formula PNG media_image1.png 160 220 media_image1.png Greyscale , where the sum of m and n is 2 or 3 such that ring A is a piperidine ring or a pyrrolidine ring, ring B is an optionally substituted aromatic ring (claims 19 and 20), ring D is a an optionally substituted aromatic ring including 3,5-bis(trifluoromethyl)phenyl group or a 3,5-dichlorophenyl group (claims 21 and 24), and L is a group represented by the formula PNG media_image3.png 124 346 media_image3.png Greyscale (claims 25-27). Additionally, the definitions of R1 and R2 are the same for both the ‘334 patent and the present reissue claims (claims 22 and 23.) Therefore, claims 18-27 are anticipated by claim 8 of the ‘334 patent. Claims 32-37 of the ‘334 patent are composition and method claims that are dependent on claim 18 of the ‘334 patent. Claim 18 of the ‘334 patent claims compounds of the formula PNG media_image4.png 184 228 media_image4.png Greyscale , where ring B is an optionally substituted aromatic ring, ring D is an optionally substituted phenyl ring or aromatic heterocyclic group, and L is a group represented by the formula PNG media_image2.png 104 446 media_image2.png Greyscale . Present reissue claims 18-27 claim compounds of the formula PNG media_image1.png 160 220 media_image1.png Greyscale , where the sum of m and n is 2 or 3 such that ring A is a piperidine ring or a pyrrolidine ring, ring B is an optionally substituted aromatic ring (claims 19 and 20), ring D is an optionally substituted aromatic ring including 3,5-bis(trifluoromethyl)phenyl group or a 3,5-dichlorophenyl group (claims 21 and 24), and L is a group represented by the formula PNG media_image3.png 124 346 media_image3.png Greyscale (claims 25-27). Additionally, the definition of R2 is the same for both the ‘334 patent and the present reissue claims (claim 23), and the definition of R1 includes the alkyl group substituted by a C-1-6 alkoxy group required by claim 18 of the ‘334 patent (claim 22). Claims 28-33 are composition and method claims as per claims 32-37 of the ‘334 patent. Therefore, claims 18-33 are anticipated by claims 18 and 32-37 of the ‘334 patent. Claims 18-20, 22, 23, 26, and 28-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 and 35-40 of U.S. Patent No. RE49,686. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 18 of the ‘686 patent claims compounds of the formula PNG media_image5.png 170 264 media_image5.png Greyscale , where ring B is an optionally substituted aromatic heterocyclic group and ring D is an optionally substituted aromatic heterocyclic group excluding 6-quinolyl, R1 is a heterocyclic group, and R2 is a hydrogen atom, a halogenated C1-6 alkyl group, or an optionally substituted C3-6 cycloalkyl group. Claims 35-40 of the ‘686 patent are composition and method claims that are dependent on claim 18 of the ‘686 patent. Present reissue claims 18-20, 22, 23, and 26 claim compounds of the formula PNG media_image1.png 160 220 media_image1.png Greyscale , where the sum of m and n is 2 or 3 such that ring A is a piperidine ring or a pyrrolidine ring, ring B is an optionally substituted aromatic ring including pyridyl and thienyl (claims 19 and 20), ring D is a an optionally substituted aromatic ring (claim 21), and L is a group represented by the formula PNG media_image3.png 124 346 media_image3.png Greyscale (claim 26). Additionally, the definition of R2 is the same for both the ‘334 patent and the present reissue claims (claim 23), and the definition of R1 includes the heterocyclic group required by claim 18 of the ‘686 patent (claim 22). Claims 28-33 are composition and method claims as per claims 35-40 of the ‘686 patent. Therefore, claims 18-20, 22, 23, 26, and 28-33 are anticipated by claims 18 and 35-40 of the ‘686 patent. Response to Arguments On page 9 of the remarks, the Applicant argues: PNG media_image6.png 212 538 media_image6.png Greyscale However, the Applicant has not pointed to any specific deficiency in the nonstatutory double patenting rejections above. Therefore, the rejections are maintained for the reasons of record. Duty to Disclose Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 8,592,454 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04. Conclusion Claims 18-33 are rejected. 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 Joseph Kosack whose telephone number is 571-272-5575. The examiner can normally be reached M-F 8:00-4:30. 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, Timothy Speer can be reached at 313-446-4825. 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. /JOSEPH R KOSACK/Patent Reexamination Specialist Central Reexamination Unit 3991 Conferees: /Alan Diamond/ Patent Reexamination Specialist Central Reexamination Unit 3991 /Patricia L Engle/SPRS, Art Unit 3991
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Prosecution Timeline

May 18, 2023
Application Filed
May 01, 2025
Non-Final Rejection — §DP
Nov 05, 2025
Response Filed
Nov 25, 2025
Final Rejection — §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
75%
Grant Probability
69%
With Interview (-5.9%)
2y 9m
Median Time to Grant
Moderate
PTA Risk
Based on 1285 resolved cases by this examiner. Grant probability derived from career allow rate.

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