Prosecution Insights
Last updated: October 04, 2026
Application No. 18/891,180

PHARMACEUTICAL COMPOSITIONS CONTAINING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVES AND PRODRUG THEREOF

Non-Final OA §DP
Filed
Sep 20, 2024
Priority
Aug 10, 2016 — JP 2016-157732 +6 more
Examiner
CHAO, ALLEN
Art Unit
Tech Center
Assignee
Shionogi & Co., Ltd.
OA Round
1 (Non-Final)
56%
Grant Probability
Moderate
1-2
OA Rounds
12m
Est. Remaining
56%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allowance Rate
5 granted / 9 resolved
-4.4% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
53 currently pending
Career history
52
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
45.5%
+5.5% vs TC avg
§102
18.2%
-21.8% vs TC avg
§112
26.7%
-13.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 9 resolved cases

Office Action

§DP
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 This office action is in response to the application filed 20 September 2024, claiming priority from JP2016-157732 filed 10 August 2016, related to PCT/JP2017/028923 filed 09 August 2017, CON of 16/323,580 filed 06 February 2019, CON of 16/937,877 filed 24 July 2020, CON 17/689,194 filed 08 March 2022, CON of 18/369,972 filed 19 September 2023, and CON of 18/424,120 filed 26 January 2024. Claims 2-24 are canceled. Currently, claim 1 is pending. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statements (IDSs) submitted on 20 September 2024 and 02 May 2025 were filed on and after the mailing date of the application on 20 September 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Specification Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. The abstract of the disclosure is objected to because the abstract contains more than 150 words and fails to convey concisely a statement of the technical disclosure by merely reproducing the claim. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Double Patenting The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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. Claim 1 is rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,633,397 (formerly Appl. No. 16/221,733). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound described in the claims read on formula I of claim 1 the instant application. Claim 1 is rejected on the ground of non-statutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,392,406 (formerly Appl. No. 15/569,191). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound described in the claim read on formula I of claim 1 of the instant application. Summary Claim 1 is rejected under non-statutory double patenting. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300. 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, James H Alstrum-Acevedo can be reached at 571-272-5548. 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. /ALLEN CHAO/Examiner, Art Unit 1622 /JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Read full office action

Prosecution Timeline

Sep 20, 2024
Application Filed
Sep 23, 2026
Non-Final Rejection mailed — §DP (current)

Precedent Cases

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Study what changed to get past this examiner. Based on 3 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
56%
Grant Probability
56%
With Interview (+0.0%)
3y 0m (~12m remaining)
Median Time to Grant
Low
PTA Risk
Based on 9 resolved cases by this examiner. Grant probability derived from career allowance rate.

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