DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2 Applicant's amendment, filed on 01/20/2026, is acknowledged.
3. Claims 216-233 and 250-257 are pending.
4. Applicant’s election without traverse of Group I, claims 216-233 (now claims 216-223 and 250-257) directed to a method of detecting tau in a biological sample obtained from a subject, and the species of an anti-tau antibody comprising a HCDR1-3 of SEQ ID NOs 42, 43, LDF, HCDR1-3 of SEQ ID NO: 12, 13, 14; comprising the VH and VL of SEQ ID NOs: 19 and 20, 19 and 21; 19 and 22; 19 and 23; 47 and 20; 47 and 21; 47 and 22; and 47 and 23, filed on 01/20/2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
5. Upon reconsideration, the examiner has extended the search to cover all the antibody species.
6. Claims 216-233 and 250-257 are under examination as they read on a method of detecting tau in a biological sample obtained from a subject.
7. Applicant’s IDS, filed 01/03/2024, 04/28/2025, 09/17/2025, is acknowledged.
8. 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.
9. Claims 216-233 and 250-257 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-257 of U.S. Patent No. 10889638 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because methods of detecting tau protein deposits in a subject having or at risk of a disease associated with tau aggregation or deposition, comprising administering to a subject a monoclonal antibody that binds human tau, comprising three Kabat/Chothia Composite heavy chain CDRs, CDR-H1 of SEQ ID NO:8, CDR-H2 of SEQ ID NO:9, and CDR-H3 of amino acid sequence LDF, and three Kabat/Chothia Composite light chain CDRs, CDR-L1 of SEQ ID NO:12, CDR-L2 of SEQ ID NO:13, and CDR-L3 of SEQ ID NO:14, except that position H27 is occupied by F or Y, H28 is occupied by N or T, H29 is occupied by I or F, H30 is occupied by K or T, position H51 is occupied by I or V, position H54 is occupied by N or D, position H60 is occupied by D or A, H61 is occupied by P or E, and H102 is occupied by F or Y., and detecting the antibody bound to tau in the subject.
The claims of the `638 patent anticipate the instant claims.
10. Claims 216-233 and 250-257 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No.11584791 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '791 patent would render obvious at least claims 216, 218-224, 231-233, and 250- 257 in the instant application (see analysis below).
Please note that the instant application and the '719 patent share at least one inventor and/or assignee (e.g., The Board of Trustees of the Leland Stanford Junior University). Further, the '719 patent is not related to the instant application as a DIV and thus no "121 shield" exists here. See filing receipt. See also MPEP § 804.01. See also Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362 (Fed. Cir. 2008) (“the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications … This is true even if the … application was mistakenly filed … and should have been filed as a DIV application.”). See also Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F. 3d 1340, 1354 (CAFC 2009) (“Amgen does not dispute that it denominated the '178 and '179 applications continuations, that it checked the continuation application box on the submitted form, or that its applications met the PTO's definition of a continuation application in MPEP § 201.07. … Instead, Amgen argues that, because the '178 and '179 continuation applications could have been filed as divisional applications, we should treat them as such for purposes of § 121. While this argument convinced the district court to regard the '178 and '179 continuation applications as divisional applications, we are not likewise convinced. We decline to construe ‘divisional application’ in § 121 to encompass Amgen's properly filed, properly designated continuation applications.”).
Accordingly, it would have been prima facie obvious to use the encoded antibodies set forth in claim 1-16 the humanized version thereof obtained in the method set forth in claim 17 for “detecting tau in a biological sample obtained from a subject,” 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.”)
11. No claim is allowed.
12. 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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February 13, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644