CTNF 18/627,889 CTNF 80605 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-fti AIA The present application is being examined under the pre-AIA first to invent provisions. The instant application is a CON of 17/160,087 (abandoned), which is a CON of 16/200,469, now US Pat. No. 10,947,511, which is a CON of 13/998,883, now US Pat. No. 10,138,465. Claims 1-20 are examined in the instant application. Double Patenting 08-33 AIA 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. 08-34 AIA Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-6 of U.S. Patent No. 10,947,511 . Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed method of culturing foregut endoderm cells (claim 1) or pancreatic foregut precursor cells (claims 17 and 18) in a cell culture comprising triiodothyronine and an ALK5 inhibitor is fully claimed in claim 1 in ‘511 . Further, dependent claims 2-16, 19 and 20 use the same combination of cell culture factors as those recited in claims 2-6 of ‘511. The instant application was filed as a CON and the court has found that safe harbor does not apply when the continuing application is filed as CON. The court found that safe harbor from an ODP rejection only applies when a continuing application is filed as a DIV. See AMGEN INC., v. F. HOFFMANN-LA ROCHE LTD. 580 F.3d l340; 2009 U.S. App, LEXIS 20409; 92 U.S.P.Q.2D (BNA) 1289 . 08-34 AIA Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-53 of U.S. Patent No. 10,344,264 . Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed method of culturing foregut endoderm cells (claim 1) or pancreatic foregut precursor cells (claims 17 and 18) in a cell culture comprising triiodothyronine and an ALK5 inhibitor is fully claimed in claims 1, 15, 25 and 32 in ‘264 . Further, dependent claims 2-16, 19 and 20 use the same combination of cell culture factors as those recited in claims 2-14, 16-24, 26-31 and 33-35 of ‘264 . 08-34 AIA Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-53 of U.S. Patent No. 10,138,465 . Although the claims at issue are not identical, they are not patentably distinct from each other because instantly claimed method of culturing foregut endoderm cells (claim 1) or pancreatic foregut precursor cells (claims 17 and 18) in a cell culture comprising triiodothyronine and an ALK5 inhibitor is fully claimed in claims 1, 19, 37, 41 and 50 in ‘465 . Further, dependent claims 2-16, 19 and 20 use the same combination of cell culture factors as those recited in claims 2-18, 20-36, 39, 40, 42-49 and 51-53 of ‘264. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6. 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, Peter Paras can be reached at 571-272-4517. 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. /DAVID A MONTANARI/Examiner, Art Unit 1632 Application/Control Number: 18/627,889 Page 2 Art Unit: 1632 Application/Control Number: 18/627,889 Page 3 Art Unit: 1632 Application/Control Number: 18/627,889 Page 4 Art Unit: 1632 Application/Control Number: 18/627,889 Page 5 Art Unit: 1632 Application/Control Number: 18/627,889 Page 6 Art Unit: 1632
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