DETAILED ACTION
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/07/2026 has been entered.
2. Claims 1, 22, 24, 38, 40, 42, 48, 50, 58 and 60 are pending and under Examination.
3. Applicant’s IDS, filed 04/07/2026, is acknowledged.
4. 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.
5. Claims 1, 22, 24, 38, 40, 42, 48, 50, 58 and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 11389533 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `533 patent claims directed to methods of treating a vedolizumab non-responder having moderately to severely active ulcerative colitis, the method comprising intravenously administering vedolizumab at a dose of 600 mg to the non-responder at week 6 following a first intravenous 300 mg dose of vedolizumab at day 1, wherein the non-responder is a patient having moderately to severely active ulcerative colitis who is characterized as having either a vedolizumab rate of clearance of greater than 0.14 L/day or a serum vedolizumab concentration threshold of less than 50 μg/mL at week 5 following the first dose of vedolizumab, and wherein the non-responder received a second intravenous 300 mg dose of vedolizumab week 2 following the first 300 mg dose at day 1, wherein the next dose and subsequent doses of vedolizumab is 300 mg, wherein the doses are administered at four week intervals, wherein the treatment results in discontinuation of corticosteroid use. The claims of the `533 patent render the instant claims obvious.
6. Claims 1, 22, 24, 38, 40, 42, 48, 50, 58 and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12286479 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `533 patent claims directed to methods for treating inflammatory bowel disease (IBD) in a human patient in need thereof, the method comprising intravenously administering an initial dose of 300 mg of a humanized antibody having binding specificity for human α4β7 integrin to the human patient, intravenously administering a second dose of 300 mg of the humanized antibody to the human patient 2 weeks after the initial dose, and subcutaneously administering a dose of 108 mg of the humanized antibody to the human patient via a prefilled syringe or an autoinjector every two weeks starting at 6 weeks after the initial dose, wherein the IBD is ulcerative colitis or Crohn's disease, wherein the treated human patient is in clinical remission, and wherein the humanized antibody is an IgG1 isotype and comprises the following CDRs: Light chain: CDR1 SEQ ID NO: 11 CDR2 SEQ ID NO: 12 CDR3 SEQ ID NO: 13 Heavy chain: CDR1 SEQ ID NO: 8 CDR2 SEQ ID NO: 9 CDR3 SEQ ID NO: 10, where the human patient previously received treatment with at least one corticosteroid for the inflammatory bowel disease. The claims of the `479 patent render the instant claims obvious.
7. No claim is allowed.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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May 3, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
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