CTNF 18/741,322 CTNF 98240 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Status Claims 116-138 are pending. Claims 116-138 are rejected. 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. Claims 116-138 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,377,451. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the patent discloses each of the compounds recited in instant claim 1 and pharmaceutically acceptable salts thereof. With respect to the fact that patent’s claims are drawn to compounds and pharmaceutical compositions while the instant claims are drawn to methods of treating brain cancer, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. The instantly claimed utility, i.e., treatment of brain cancers such as glioblastoma multiforme by administering the claimed compounds to a subject is disclosed in Col 2., lines 57-61. A person of ordinary skill seeking to use the patent’s pharmaceutical compositions would be motivated to administer the product to a subject in need thereof as suggested in the disclosure of the patent. Closest Prior Art The closest prior art appears to be US 2003/0045537 A1 by Lee et al. The prior art discloses EGFR inhibitors such as the following compounds (paragraphs [0094] and [0113]): PNG media_image1.png 334 376 media_image1.png Greyscale PNG media_image2.png 338 368 media_image2.png Greyscale . Prior art example 23 is analogous to the first compound of instant claim 116 and prior art example 28 is analogous to the 6 th compound of the instant claim. The prior art compounds differ from the instant compounds in that the phenyl ring is only substituted by bromine in the meta position whereas the instant compounds also have a fluorine substituent in the ortho position. The prior art does not disclose any compounds where this ring is substituted by a halogen in the meta and ortho positions at carbons 2 and 3. Examples 13 and 17 shown below possess a phenyl ring substituted by two halogens however, neither compound has a bromine substituent or a halogen substituent at both carbons 2 and 3 (paragraphs [0063] and [0075]): PNG media_image3.png 342 364 media_image3.png Greyscale PNG media_image4.png 354 394 media_image4.png Greyscale . The prior art provides no motivation or guidance for modifying the disclosed compounds in a manner that would result in any of the compounds of instant claim 116. Furthermore, the prior art teaches that the compounds are EGFR inhibitors but is silent to their utility for treating brain cancer; therefore, a person of ordinary skill seeking to implement the teachings of Lee et al. would lack guidance for modifying the compounds in a manner that would potentially make them more useful in a way that aligns with the instant method of treatment. For these reasons, the prior art neither anticipates nor renders obvious the instant claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m.. 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. /A.A.C./Examiner, Art Unit 1626 /MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626 Application/Control Number: 18/741,322 Page 2 Art Unit: 1626 Application/Control Number: 18/741,322 Page 3 Art Unit: 1626 Application/Control Number: 18/741,322 Page 4 Art Unit: 1626 Application/Control Number: 18/741,322 Page 5 Art Unit: 1626 Application/Control Number: 18/741,322 Page 6 Art Unit: 1626
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