DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s response and amendments received January 6, 2026 are acknowledged.
Claims 2, 4, 6-8, 10-12, and 14 have been canceled.
Claims 1, 3, 5, 9, 13, 15-19 have been amended.
Claims 20-39 have been added.
Claims 1, 3, 5, 9, 13, and 15-39 are pending in the instant application.
Claims 1 and 16-19 are independent, and all claims recite administering anti-tau antibodies to a subject to treat disease
Applicant’s election without traverse of the anti-tau antibody species comprising the six CDRs of SEQ ID NOs:11-13 and 17-19 in the reply filed on January 6, 2026 is acknowledged. It should be noted that these CDRs are disclosed in the specification as belonging to clone 16B5.
Information Disclosure Statement
The IDS form received January 5, 2024 is acknowledged and the references cited therein have been considered.
Double Patenting
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.
Claims 1, 3, 5, 9, 13, and 15-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,752679. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims of the ‘679 patent recite antibodies that are defined by SEQ ID number and bind human tau, as well as methods of administering such antibodies to treat or effect prophylaxis of a disease associated with tau, including Alzheimer’s disease (see all issued claims, particularly issued claims 1, 23 and 24). Notably the light chain variable domain of the antibody of the issued claims is recited as comprising a biological sequence 100% identical to instant SEQ ID NO:22 (i.e. issued SEQ ID NO:36, see enclosed sequence alignments) while the heavy chain variable domain comprises all of the CDR sequences recited in the independent claims and is 99% identical to instant SEQ ID NO:15 (issued SEQ ID NO:35, see below as well as enclosed alignments).
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Additionally, the issued methods are not only recited as treating and effecting prophylaxis but also “reducing aberrant transmission of tau” (compare issued claim 26 to instant claim 16), “inducing phagocytosis of tau” (compare issued claim 27 to instant claim 17), “inhibiting tau aggregation” (compare issued claim 28 to instant claim 18) and “inhibiting formation of tau tangles” (compare issued claim 29 to instant claim 19). Given that the issued administration methods administer anti-tau antibodies comprising more sequence information than just the six CDR sequences as are recited in the instant independent claims, the issued therapeutic methods necessarily anticipate the breadth of what is presently claimed.
Claims 1, 3, 5, 9, 13, and 15-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,492,393. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are either anticipated by or are obvious variants of the issued claims.
Specifically, the issued claims of the ‘393 patent recite antibodies that are defined by SEQ ID number and bind human tau, as well as methods of administering such antibodies to treat or effect prophylaxis of a disease associated with tau, including Alzheimer’s disease (see all issued claims, particularly issued claims 1, 7, and 9). Notably the light chain variable domain of the antibody of the issued claims is recited as comprising a biological sequence 100% identical to instant SEQ ID NO:22 (i.e. issued SEQ ID NO:36, see enclosed sequence alignments) while the heavy chain variable domain comprises all of the CDR sequences recited in the independent claims and is 99% identical to instant SEQ ID NO:15 (issued SEQ ID NO:35, see below as well as enclosed alignments) with the administered antibodies further having antibody constant domains defined by recited SEQ ID numbers.
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While the issued method claims recite administering anti-tau antibodies for treating and effecting prophylaxis of tau diseases including Alzheimer’s, the issued claims do not recite that such administrations “reduce aberrant transmission of tau”, “induce phagocytosis of tau”, “inhibit tau aggregation” or “inhibit formation of tau tangles”. However, all such methods recite the exact same process step, namely administration of an antibody that binds tau defined by polypeptide sequence to the same patient population, specifically Alzheimer’s patients. As such the statements of the preambles such as “inducing tau phagocytosis” or “inhibiting tangle formation” reasonably appear to be a statement of the biological mechanism by which treatment or prophylaxis of Alzheimer’s is a achieved as no differential dosing or alternate timings of administration are recited in any claims. Indeed, all pending claims are not limited to any particular dose or frequency of administration and thus the same process step, i.e. administering an anti-tau antibody limited by recited SEQ ID numbers to Alzheimer’s patients is carried out in all instant claimed methods as well as the previously issued methods which provide additional sequence information concerning the administered anti-tau antibody. Given that the preambles recite the intended result or “purpose” but do not alter the drug administered, the patient population, or the amount or timing of administrations, such intended results do not provide patentable distinctiveness that limits the instant claimed inventions to something patentably distinct from that previously issued to applicant. See also MPEP 2111.02.
Claims 1, 3, 5, 9, 13, and 15-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,195,525. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are either anticipated by or are obvious variants of the issued claims.
Specifically, the issued claims of the ‘525 patent recite antibodies that are defined by SEQ ID number and bind human tau, as well as methods of administering such antibodies to treat or effect prophylaxis of a disease associated with tau, including Alzheimer’s disease (see all issued claims, particularly issued claims 1 and 18-20). Notably the light chain variable domain of the antibody of the issued claims is recited as comprising a biological sequence 100% identical to instant SEQ ID NO:22 (i.e. issued SEQ ID NO:36, see enclosed sequence alignments) while the heavy chain variable domain comprises all of the CDR sequences recited in the independent claims and is 99% identical to instant SEQ ID NO:15 (issued SEQ ID NO:15, see below as well as enclosed alignments).
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While the issued method claims recite administering anti-tau antibodies for treating and effecting prophylaxis of tau diseases including Alzheimer’s, the issued claims do not recite that such administrations “reduce aberrant transmission of tau”, “induce phagocytosis of tau”, “inhibit tau aggregation” or “inhibit formation of tau tangles”. However, all such methods recite the exact same process step, namely administration of an antibody that binds tau defined by polypeptide sequence to the same patient population, specifically Alzheimer’s patients. As such the statements of the preambles such as “inducing tau phagocytosis” or “inhibiting tangle formation” reasonably appear to be a statement of the biological mechanism by which treatment or prophylaxis of Alzheimer’s is a achieved as no differential dosing or alternate timings of administration are recited in any claims. Indeed, all pending claims are not limited to any particular dose or frequency of administration and thus the same process step, i.e. administering an anti-tau antibody limited by recited SEQ ID numbers to Alzheimer’s patients is carried out in all instant claimed methods as well as the previously issued methods which provide additional sequence information concerning the administered anti-tau antibody. Given that the preambles recite the intended result or “purpose” but do not alter the drug administered, the patient population, or the amount or timing of administrations, such intended results do not provide patentable distinctiveness that limits the instant claimed inventions to something patentably distinct from that previously issued to applicant. See also MPEP 2111.02.
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 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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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641