Prosecution Insights
Last updated: April 19, 2026
Application No. 17/896,758

PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE

Non-Final OA §DP
Filed
Aug 26, 2022
Examiner
FUBARA, BLESSING M
Art Unit
1613
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Chugai Seiyaku Kabushiki Kaisha
OA Round
4 (Non-Final)
62%
Grant Probability
Moderate
4-5
OA Rounds
3y 3m
To Grant
96%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allow Rate
786 granted / 1270 resolved
+1.9% vs TC avg
Strong +34% interview lift
Without
With
+34.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
38 currently pending
Career history
1308
Total Applications
across all art units

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
36.3%
-3.7% vs TC avg
§102
18.6%
-21.4% vs TC avg
§112
20.6%
-19.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1270 resolved cases

Office Action

§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 . The examiner acknowledges receipt of IDS filed 10/22/2025 and 10/06/2025, request for continued examination under 37 CFR 1.114, request for extension of time, amendment and remarks, all filed 12/17/2025. New claims 72 and 73 are added. Claims 36, 44-46, 54-55, 62-69 and 71 are canceled. Claims 56-61, 70 and 72-73 are pending. Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/17/2025 has been entered. Response to Arguments Applicant’s arguments, see pages 4-6 of the remarks, filed 12/17/2025, with respect to the rejection of claim(s) 36, 44-46 and 54-55 and 69; and 56-61 and 70; and 62-68 and 71 under 35 U.S.C. 103 as being unpatentable over FURUMOTO et al., (WO 2012023597 Al using US 20130143877 Al as translation) in view of Smith et al., "Crystallization of sodium dodecyl sulphate from aqueous solution: phase identification, crystal morphology, surf ace chemistry and kinetic interface roughening" in Journal of crystal Growth, 263, (2004) 480-490 have been fully considered and are persuasive. The rejection of claims 36, 44-46 and 54-55 and 69, and 56-61 and 70, and 62-68 and 71 has been withdrawn. The rejection of claims 36, 56-57, 61 and 62-64 on the ground of non-statutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9365514 B2 in view of Smith et al., "Crystallization of sodium dodecyl sulphate from aqueous solution: phase identification, crystal morphology, surface chemistry and kinetic interface roughening" in Journal of crystal Growth, 263, (2004) 480-490 is withdrawn because applicant’s argument that US 9365514 B2 does not teach the sodium lauryl sulfate is obtained by crystallization is persuasive. The rejection of claims 36 and 56-71 on the ground of non-statutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10646468 B2 and 11433076 B2 is withdrawn because applicant’s argument is persuasive that US 10646468 B2 and US 11433076 B2 do not teach the sodium lauryl sulfate is obtained by crystallization. However, US 10350214 B2 teaches that the sodium lauryl sulfate is obtained by crystallization (see claims 7 and 21 and 8 and 22 for weight ratios of compound of formula (I) top sodium lauryl sulfate solubilizing agent. 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. Claims 56-61, 70 and 72-73 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 103560214 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued composition comprises compound of formula (I) and lauryl sulfate that is obtained by crystallization (claims 1, 5, 6, 7, 15, 20 and 21) and a weight ratio of the compound of formula (I) to the lauryl sulfate is from 100:2 to 100:60 (claims 8 and 22) and this teaching in issued claims 1-24 anticipates the examined claims 56-61, 70 and 72-73. The comprising language is open. No claim is allowed. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T). 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, Brian Yong Kwon can be reached at 5712720581. 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. /BLESSING M FUBARA/Primary Examiner, Art Unit 1613
Read full office action

Prosecution Timeline

Aug 26, 2022
Application Filed
Apr 06, 2024
Non-Final Rejection — §DP
Sep 11, 2024
Response Filed
Dec 02, 2024
Non-Final Rejection — §DP
Apr 29, 2025
Response Filed
Jun 14, 2025
Final Rejection — §DP
Dec 15, 2025
Applicant Interview (Telephonic)
Dec 17, 2025
Request for Continued Examination
Dec 18, 2025
Response after Non-Final Action
Dec 25, 2025
Non-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

4-5
Expected OA Rounds
62%
Grant Probability
96%
With Interview (+34.2%)
3y 3m
Median Time to Grant
High
PTA Risk
Based on 1270 resolved cases by this examiner. Grant probability derived from career allow rate.

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