CTNF 17/931,704 CTNF 96399 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. Continued Examination Under 37 CFR 1.114 07-42-04 AIA 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/28/26 has been entered. Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. §119(e) or under 35 U.S.C. §120, §121, or §365(c) is acknowledged. As noted in the Non-Final Office Action mailed 21 August 2025, Applicant has claimed the benefit of the filing date of the prior application, and designates the instant application as a "CON" of 17/019,497. Applicant has complied with all of the conditions for receiving the benefit of an earlier filing date under 35 U.S.C. §120 or §365(c). Claims 17, 25-27, 31, 33 and 46-59 have the effective filing date of 08 June 2015. DETAILED ACTION In light of the claim amendments received on 4/28/26, the rejection of claims 48, 55 and 58 under 35 USC 112(b) is withdrawn. Claims 17, 26, 27, 31, 33, and 46-59 are under examination herein. Drawings 06-22 AIA The drawings are objected to because the figures are not properly labeled. 37 CFR 1.84 (u)(1) states “The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.” In the instant case, the view numbers for Figures are preceded by the word "Figure" instead of the abbreviation "FIG." . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Objections 07-43 Claims 46-58 are objected to as being dependent (directly or indirectly) upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Examiner's Comment As noted in the Non-Final Office Action mailed 21 August 2025, no prior art was found with regard to a polypeptide having the amino acid substitution, 130A, 131M, 179F, 210Q, 260Q or 274T, the polypeptide being at least 90% identical to the amino acid sequence of SEQ ID NO: 71. 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/terminal-disclaimer. Claims 17, 26, 27, 31, 33, and 59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 16 of Patent No. 10,793,846 B2 (hereafter 846). Although the claims are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the patent claims. The instant claim 17 recites: Claim 17. A polypeptide comprising an amino acid sequence at least 90% identical to the amino acid sequence of SEQ ID NO: 71, wherein: (a) residue 278 is Ser, residue 78 is Glu, and residue 82 is Asp; and (b) the polypeptide comprises an amino acid change from SEQ ID NO: 71 at one or more residues selected from the group consisting of 32D/N/Q/H, 72S, 73A/D/E/G/L/M/N/Q/R/T, 75A, 79S/T/A, 80L/T, 81A/T/V, 128A/T, 130A, 131M, 165A/D/E/K/N/Q/R/T/Y, 169A/N/S/Q/T, 179A/D/E/F/N/Q/S/T, 210Q, 213S/Q, 217S, 235K, 257S, 260A/E/N/Q, 267V, 272R, and 274A/L/M/Q/R/T/V. Regarding instant claims 17, 27, 31 and 33 , claim 15 of Patent No. 10,793,846 recites: Claim 15. A polypeptide comprising an amino acid sequence at least 90% identical to the amino acid sequence of SEQ ID NO: 71, wherein: (a) residue 278 is Ser, residue 78 is Glu, and residue 82 is Asp; and (b) the polypeptide comprises an amino acid change from SEQ ID NO: 71 at one or more residues selected from the group consisting of 274A/L/M/Q/R/T/V, 32D/N/Q/H, 73E, 75A, 79S/T/A, 80L/T, 81A/T/V, 130A, 131M, 165A/E/Q/R/Y, 169N/S/Q/T, 179F/Q, 210Q, 213S/Q, 217S, 235K, 260E/N/Q, 267V and 272R. Regarding instant claim 26, 846 claim 16 recites mutations can further comprise 210Q, 260E/N/Q mutations. Regarding instant claim 59, 846 column 3 lines 19-36 teach a pharmaceutical composition comprising the peptide and a pharmaceutically acceptable carrier. As demonstrated above in the claim-to-claim comparison, the polypeptide comprising an amino acid sequence at least 90% identical to SEQ ID NO.: 71, in Patent No. 10,793,846 B2 recites species modifications that anticipate the polypeptide comprising an amino acid sequence at least 90% identical to SEQ ID NO.: 71, recited in instant Application No. 17/931,704. Response to Arguments Applicant’s arguments, pg. 4, filed on 4/28/26, with respect to the obviousness-type double patenting rejection, have been fully considered, but they are not persuasive. Applicant argues (pg. 6) that Applicant has amended claim 17 to add a limitation from claim 25. Claims 15-16 of 874 recite all the claimed limitations as explained in the double patent rejection above. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm. 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, Louise Humphrey can be reached at 571-272-5543. 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. /TREVOR KANE/Examiner, Art Unit 1657 /LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657 Application/Control Number: 17/931,704 Page 2 Art Unit: 1657 Application/Control Number: 17/931,704 Page 3 Art Unit: 1657 Application/Control Number: 17/931,704 Page 4 Art Unit: 1657 Application/Control Number: 17/931,704 Page 5 Art Unit: 1657 Application/Control Number: 17/931,704 Page 6 Art Unit: 1657 Application/Control Number: 17/931,704 Page 7 Art Unit: 1657 Application/Control Number: 17/931,704 Page 8 Art Unit: 1657
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