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 .
Claim 4 is cancelled. Claims 1-3 and 5-11 are pending and under examination.
Priority
This application is a continuation of PCT/JP2022/021103 filed on 5/23/2022, which claims priority to US provisional application 63/192,366 filed on 5/24/2021.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/17/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/03/2026 was filed after the mailing date of the final rejection on 03/17/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objections and Rejections Withdrawn
The rejection under USC 103 over Kasagi in view of Inspire and Morris is withdrawn per applicant’s arguments and affidavit filed on 6/17/2026.
The rejection under USC 103 over Kasagi in view of Inspire; Morris and CN101185634A is withdrawn per applicant’s arguments and affidavit filed on 6/17/2026.
The rejections under non-statutory double patenting over US 11413244, US 11446247, US 12370186 and US 12370214 are withdraw per applicant’s arguments and affidavit regarding the dosing regimen.
As these rejections are withdrawn, applicant’s arguments toward these rejections are moot.
Maintained Rejection
Non-Statutory 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 1-3 and 5-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9 of copending 18/516,010 (issue fee now paid). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for treating cancer with a similar formulation of topotecan having similar liposomes. ‘010 provides the species of Merkel cancer (a cancer of applicant’s claims), and thus, it would be seen for one of ordinary skill in the art to use this with patients affected by this cancer. ‘010 provides for intravenous administration and the dose rate of the applicant’s claims. Intravenous administration of ‘010 is a genus that includes injections and infusions.
Response to Applicant’s Arguments and Affidavit
Applicant’s arguments and affidavit filed on 6/17/2026 as the provide the basis for markedly improved results (lower toxicity while staying efficacious with the lower doses given once every two weeks) when administering the composition in the claim at a dose with dose rates and timing as in applicant’s claims. Thus, the claims are not obvious over the cited prior art used in rejections under USC 103 or over non-statutory double patenting in regards to US 11413244, US 11446247, US 12370186 and US 12370214, which relied on citing other references to teach such dosing. However, the rejection over copending 18/516,010 (now paid issue fee) is maintained as the claims provide for the dosing regimen of applicant’s claims and treating a cancer in a patient. As a terminal disclaimer has not been filed toward this copending application (now issued), this rejection is maintained.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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 (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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