CTNF 18/545,176 CTNF 79937 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. Claims 1, 3-19, 22-27, and 32-34 are pending as amended 9/3/24 and are considered herein. Formalities: The drawings of 12/19/23 are accepted. The specification, as amended 4/15/25 is accepted. The IDS of 12/19/23 and references therein have been considered and a signed copy is provided herewith. Applicant’s priority is noted to be: PNG media_image1.png 122 566 media_image1.png Greyscale 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, 3-19, 22-24, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-27 of U.S. Patent No. 10,744,170 . Although the claims at issue are not identical, they are not patentably distinct from each other because : Claim 1: Claim 1 of the patent teaches treating a tumor, comprising administration of a chimeric poliovirus construct comprising a sabin type 1 strain of poliovirus with a human rhinovirus 2 (HRV2) IRES in the 5’ IRES between the cloverleaf and ORF, and administering an immune check point inhibitor. The checkpoint inhibitor may be an anti-PD-1 antibody (Claim 20). Claim 3: the tumor may be a glioblastoma (Claim 2). Claim 4: the tumor may be an astrocytoma or oligodendroglioma (Claim 3). Claim 5: the tumor may be an astro-oligodendroglioma (Claim 4). Claim 6: the tumor may be a renal cell carcinoma (Claim 5). Claim 7: the tumor may be a prostate tumor (Claim 6 – it is clear this is a typo in the patent, and the support is found as prostatic tumors (e.g., ABSTRACT)). Claim 8: the tumor may be a bladder tumor (e.g., Claim 7). Claim 9: the tumor may be an esophageal or stomach tumor (e.g., Claim 8). Claim 10: the tumor may be a pancreatic tumor (e.g., Claim 9). Claim 11: the tumor may be a colorectal tumor (e.g., Claim 10). Claim 12: the tumor may be a liver or gall bladder tumor (e.g., Claim 11). Claim 13: the tumor may be a breast tumor (e.g., Claim 12). Claim 14: the tumor may be medulloblastoma (e.g., Claim 13). Claim 15: the tumor may be a lung tumor (e.g., Claim 14). Claim 16: the tumor may be a head and neck tumor (e.g., Claim 15). Claim 17: the tumor may be a melanoma (e.g., Claim 16). Claim 18: the tumor may be a sarcoma (e.g., Claim 17). Claim 19: the administration of the construct may be intracerebral by CED (e.g., Claim 18). Claim 22: the administration may be direct to the tumor (e.g., Claim 19). Claim 23: the antibody may be administered within 30 days of the construct (e.g., Claim 25). Claim 24: the antibody may be administered within 7 days of the construct (e.g., Claim 26). Claim 32: as shown above, the construct is administered, and the antibody is administered, and thus, the composition of both is instantly envisioned, as they must both be delivered. Further, with depending claims 25 and 30, it makes clear they may be administered together in the broad claims. Thus, in light of the patent, the invention is obvious. The Artisan would make and perform the methods, and expect success, as it is claimed . 08-36 AIA Claim s 1, 3-19, 22-24, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-27 of U.S. Patent No. 10,744,170 in view of author unknown, (July 9, 2014) “Cancer Immunotherapy Projections – Immune Checkpoint Inhibitors lead the way”, Cancer biology, no volume or issue number, published online at blogs.shu.edu/cancer/2014/07/09/cancer-immunotherapy-pro-jections-immune-checkpoint-inhibitors-lead-the-way/, 3 pages long as printed . As shown above, the base claims are obvious over the patent alone, however the use of pembrolizumab and nivolumab are not claimed (albeit, it is argued they are essential written description for the check point inhibitors encompassed). However, as seen by the article from shu.edu above, it is noted that these immune checkpoint inhibitors are known in the art at the time of invention. Thus, it would be obvious to use these inhibitors as found in Claims 26-27, in the invention of the patent. The Artisan would do so, and expect success, as they were already known immune checkpoint inhibitors, the claims teach it works with immune checkpoint inhibitors . 08-36 AIA Claim s 1, 3, 19, 22, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-22 of U.S. Patent No. 10,398,743 in view of U.S. Patent No. 11,344,620 to Lebwohl, et al . Claim 1 and 32: Claim 1 teaches treating a human with a glioblastoma tumor expressing NECL5, comprising administering a chimeric poliovirus construct comprising a Sabin type 1 strain of poliovirus with a human rhinovirus 2 (HRV2) IRES, in the 5’UTR between the cloverleaf and ORG of the poliovirus. Claim 12 teaches similar administrations of the same construct virus, by way of stereotactic CED. Claim 13 teaches the same, with CED infusion by way of a intratumoral catheter. Claim 3: the method is taught for glioblastoma (e.g., Claims 1, 12 and 14). Claim 19: Claims 1 and 12 teach CED intracerebral infusions. Claim 22: Claims 1 and 12 teach direct administration to the tumor. However, the use of pembrolizumab and nivolumab are not claimed for treating the claimed cancers. On the other hand, Claim 1 of Lebwohl teaches treating cancer with an antibody of SEQ ID NO: 2 and SEQ ID NO: 3, which is an antibody that is nivolumab (e.g., Table 1), and it is also taught that Pembrolizumab may be used (e.g., Table 2) and one cancer taught is glioblastoma (e.g., Claim 30). Thus, in light of the disclosure of the patent, and Lebwohl, it would be obvious to perform the combination treatment against glioblastoma. This is because the patent Claims the use of the viral construct, and the Lebwohl reference patent teaches the use of these anti-PD-1 antibodies, specifically. The Artisan would expect success, as the components are utilized for their art-recognized purposes . Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 07-31-01 Claims 1, 3-19, 22-27, and 32-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims are to treating a generic tumor (e.g., Claim 1), as well as multiple generic tissue-type tumors (e.g., Claims 3-18). The specification teaches that the virus must enter the tumor and act as an oncolytic virus (e.g., Technical Field of the Invention). With regard to the method of entry, to thereby effect oncolysis by replication, it is well known that the Sabin virus utilizes the Necl-5 receptor for entry (e.g., Goetz, et al. (2011) “Oncolytic poliovirus against malignant glioma”, Future Virology, 6(9): 1045-58 – cited by Applicant in the IDS of 12/19/23, NPL reference 33). The specification fails to provide much with regard to the NECL5 expression, except that it does indicate that, due to the level of expression determined, aggressiveness of the treatment with the virus may be adjusted (e.g., paragraph 17). However, not all cancers express NECL5 (e.g., Madjd, et al. (2004) “Loss of CD55 is Associated with Aggressive Breast Tumors”, Clinical Cancer Research, 10: 2797-803 – cited by Applicant in the IDS of 12/19/23, NPL reference 35). Thus, given the great numbers of types of cancer, and single teaching that the Necl-5 receptor is the mode of Sabin virus entry to then act oncolytically, the Artisan would not have understood Applicant to have been in possession of treating cancers that do not express Necl-5. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p. 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, Tracy Vivlemore can be reached at 571-272-2914. 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. ROBERT M. KELLY Examiner Art Unit 1638 /ROBERT M KELLY/ Primary Examiner, Art Unit 1638 Application/Control Number: 18/545,176 Page 2 Art Unit: 1638 Application/Control Number: 18/545,176 Page 3 Art Unit: 1638 Application/Control Number: 18/545,176 Page 4 Art Unit: 1638 Application/Control Number: 18/545,176 Page 5 Art Unit: 1638 Application/Control Number: 18/545,176 Page 6 Art Unit: 1638 Application/Control Number: 18/545,176 Page 7 Art Unit: 1638 Application/Control Number: 18/545,176 Page 8 Art Unit: 1638 Application/Control Number: 18/545,176 Page 9 Art Unit: 1638 Application/Control Number: 18/545,176 Page 10 Art Unit: 1638
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