SUBSTITUTED PYRIDINES AS DNMT1 INHIBITORS

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 . Information Disclosure Statement The lined-through reference appears to be two separate references. The examiner respectfully suggests that they should be listed individually. 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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4, 15 and 17 of (parent) U.S. Patent No. 11,771,711 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Inventor teaches a method of treating a patient having a disorder which is a cancer or a precancerous syndrome comprising administering a compound of diagramed formula (V) or its pharmaceutically acceptable salt (independent claim 1). Dependent claim 2 further defines the cancer (leukemia, endometrial cancer, CMML, etc.). Dependent claim 3 teaches that the patient is human. Inventor further teaches a method of treating a patient having a disorder which is a beta haemoglobinopathy disorder comprising administering a compound of diagramed formula (V) or its pharmaceutically acceptable salt (independent claim 4). Dependent claim 5 teaches that the disorder is sickle cell disease, sickle cell anemia or beta thalassemia. Dependent claim 6 teaches that the patient is human. Inventor further teaches a method of treating a patient having a disorder which is a beta haemoglobinopathy disorder comprising administering a compound of diagramed formula (II) or a prodrug, or its pharmaceutically acceptable salt (independent claim 7). Dependent claim 8 teaches that the disorder is sickle cell disease, sickle cell anemia or beta thalassemia. Dependent claim 9 teaches that the patient is human. Inventor further teaches a method of treating a patient having a disorder which is a cancer or a precancerous syndrome comprising administering a compound of diagramed formula (II) or a prodrug, or its pharmaceutically acceptable salt (independent claim 10). Dependent claim 11 further defines the cancer (leukemia, endometrial cancer, CMML, etc.). Dependent claim 12 teaches that the patient is human. US 11,771,711 B2 teaches a compound of diagramed formula (II) or a prodrug, or its pharmaceutically acceptable salt (independent claim 2). The reference further teaches a compound of diagramed formula (V) or its pharmaceutically acceptable salt (independent claim 4). The reference further teaches a compound of formula (II) (dependent claim 15). The reference further teaches a compound of formula (V) (dependent claim 17). The specification of 11,771,711 B2 teaches that the compound of diagramed formula (II) is a stereoisomer of the compound of diagramed formula (I) (column 5, line 18). The reference further teaches that the compound of diagramed formula (V) is a prodrug of the compound of diagramed formula (I) (column 7, line 20). The compounds and prodrugs of diagramed formula (I) are explicitly taught as being utilized in a method of treating cancer or a precancerous syndrome, or a beta haemoglobinopathy disorder (column 11, line 48), particularly in humans (column 7, line 32). The cancers explicitly include leukemia (column 12, line 58), endometrial cancer (column 12, line 40), CMML (column 13, line 2), etc. The beta haemoglobinopathy is sickle cell disease, sickle cell anemia, or beta thalassemia (column 15, line 36). Note that a claim to a method of using a compound, where an earlier patent claimed the compound and that patent’s specification disclosed the compound’s utility in the method, is not patentably distinct from the patented compound claim. (Sun Phar. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ 2d 1797 (Fed. Cir. 2010) (See MPEP 804 IIB 2(a)). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT. 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, Ali Soroush, can be reached at 571-272-9925. 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. /BRIAN J DAVIS/Primary Examiner, Art Unit 1614 9/28/2026