DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
2 Applicant's amendment, filed on 11/21/2023, is acknowledged.
3. Claims 4-23 are pending.
4. Applicant’s IDS, filed 11/29/2023, is acknowledged.
5. Claims 12 and 18 are objected to for the following informalities:
the “a4” in claim 12 should be “α4”.
The “α4integrin” in claim 18 should be “α4 integrin”. Correction is required.
6. 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.
7. Claims 4-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 12037398 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims the `398 patent are directed to anti-α4 antibody comprising identical claimed/patented SEQ ID NOs. 2 and 4, nucleic acid encoding the antibody, host cells, methods of making the antibody and methods of alleviating a symptom of a patient suffering from multiple sclerosis. The claims of the `398 patent anticipate the instant claims.
8. Claims 4-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 11571477 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims the `477 patent are directed to a vector comprising DNA encoding anti-α4 antibody comprising identical claimed/patented SEQ ID NOs. 2 and 4, methods of making the antibody and methods of alleviating a symptom of a patient suffering from multiple sclerosis. The claims of the `477 patent anticipate the instant claims 6-7. Further, it would have been prima facie obvious to make the antibodies set forth in claim 4-5, 6 and use them for “treating a patient suffering from a disease or disorder mediated by an α4 integrin” claimed in claims 8-23 before the effective filing date. See Sun Pharmaceutical industries v. Eli Lilly and Co., 611F. 3d 1381, 1385 (CAFC 2010) (“our prior obviousness-type double patenting decisions in Geneva and Pfizer . … we found claims of a later patent invalid for obviousness-type double patenting a method of using the compound for a use described in the specification of the earlier patent”). See also MPEP § 804(II)(B)(2)(“in AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (fed. Cir . 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context.”)
The CAFC has ruled that "[T]he protection afforded by Section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications. Pfizer Inc. v. Teva Pharmaceuticals Inc., 518 F.3d 1353, 1362, 86 USPQ2d 1001, 1007-1008 (Fed. Cir. 2008).
The § 121 safe harbor, “by its literal terms, protects only divisional applications (or the original application) and patents issued on such applications.” Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1360 (Fed. Cir. 2008) (internal quotation marks omitted).
9. Claims 4-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 11083791. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims the `791 patent are directed to anti-α4 antibody comprising identical claimed/patented SEQ ID NOs. 2 and 4, and methods of inhibiting binding to VCAM-1 and/or fibronectin comprising administering to said patient the composition comprising the anti-α4 antibody, wherein the patient has an inflammatory disorder, multiple sclerosis, asthma, rheumatoid arthritis, diabetes, optic neuritis, Crohn's disease, an acute disorder, a spinal cord injury or traumatic brain injury. Claims 4-5, 8-23 of the `791 patent anticipate the instant claims. Regarding Claims 6-7, it would have been prima facie obvious to prepare DNA encoding and make the antibodies set forth in claim 5-6.
10. Claims 4-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 10335485. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims the `485 patent are directed to anti-α4 antibody comprising identical claimed/patented SEQ ID NOs. 2 and 4. The claims of the `485 patent anticipate the instant claims 4-5. Further, it would have been prima facie obvious to prepare and make the antibodies set forth in claim 6-7 and use them for “treating a patient suffering from a disease or disorder mediated by an α4 integrin” claimed in claims 8-23 before the effective filing date.
11. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(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.
12. Claims 9-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of inhibiting the binding of VLA-4 (α4β1) to VCAM-1 or fibronectin in a patient, comprising administering to said patient a composition comprising the anti-α4 antibody comprising the VH and VL of SEQ ID NOs: 4 and 11, does not reasonably provide enablement for a method of treating a patient suffering from a disease or disorder mediated by an α4 integrin with the claimed antibody. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The claim is directed to a broad genus of each and every disease or disorder mediated by an α4 integrin with the claimed humanized HuHP1/2.
The specification under Example 2 discloses that humanized HP1/2 (HuHPl/2) binds VLA-4 on tumor cell lines. HuHPI/2 blocked adhesion of both types of cell lines to FN- and VCAM1-Ig- coated wells.
Applicant fails to demonstrate in vivo treatment of each and every disease or disorder mediated by an α4 integrin using anti-α4 antibodies.
However, Quann et al, (Blood Advances, 7(17):5187-5187, 2023) teaches that with respect to the treatment of GVHD with natalizumab, a humanized antibody against the α4 subunit of α4β7 integrin, unfortunately, the study failed to meet its primary end point and was closed after the interim futility analysis. There were also no significant differences between natalizumab recipients and controls when comparing the secondary outcomes of overall response rate, nonrelapse mortality, overall survival, and biomarker scores on day 28, and this was true across all subgroups analyzed (page 5187, 4th ¶). Further, there are retrospective case series of patients with steroid-refractory bowel GVHD treated with vedolizumab; however, a phase 2a trial testing vedolizumab in this setting was closed after futility analysis (see page 5188, top ¶).
The MPEP states that the issue of "correlation" is also dependent on the state of the prior art. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate. Even with such evidence, the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition. See MPEP 2164.02.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
13. No claim is allowed.
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hanf et al. Antibody humanization by redesign of complementarity-determining region residues proximate to the acceptor framework. Methods 65 (2014) 68–76.
Hanf et al teaches the humanization of claimed anti-α4 integrin antibody HP1/2 is presented.
15. 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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November 25, 2025
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644