DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-14 and 77-82 are pending and are under examination.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-14 and 77-82 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO 2018/183175 (of record).
WO 2018/183175 teaches a method of treating patients with mild to moderate Alzheimer’s disease (AD) comprising administering to the patient an anti-Tau humanized monoclonal antibody having SEQ ID NO: 18 AND 19, which is identical to SEQ ID NO: 5 and 9 of the instant application, and comprises the same CDRs of SEQ ID NO 2-4 and 6-8 of the instant application (see page 2, in particular). WO 2018/183175 teaches administering the antibody at a dose of 4500 mg weekly or monthly (see page 7, in particular). WO 2018/183175 teaches that the method slows memory loss, or retains or increases memory and cognitive function as assessed by ADAS-Cog scale (see pages 1-5 in particular). WO 2018/183175 teaches an embodiment where ADA-Cog score is maintained as compared to prior to administration of the antibody wherein cognitive function is assessed at least 13-24 weeks after beginning treatment (i.e. see pages 1-5, in particular). WO 2018/183175 teaches that the antibody is an IgG4, having M252Y, S254T, T256E, and S228P mutations, i.e. semorinemab, see the claims in particular). See also claim 2, directed to a method of treating a Tau associated disease comprising administering the same antibody of the instant claims with the same CDR sequences at a dose of 4500 mg weekly, and dependent claims 13-18, which depend from claim 2 specifying that the tauopathy is mild to moderate or moderate AD. See also claim 19-21, wherein it is taught than of the preceding claims, the treating method includes slowing or retaining memory capacity, memory function or cognitive function in the individual using ADAS-Go13 l. See also claim 26, which teaches that in the preceding claims, the cognitive function is assess at least 13 weeks after beginning treatment. See also claims 27-53 directed to a method of retaining or increasing memory capacity, function or cognitive function or slowing memory loss in an individual comprising administering the same doses of the same antibody of the instant claims, wherein said memory/cognitive function is assessed using ADAS-Cog-13 at least 13 weeks after beginning treatment and wherein the dose the antibody is 4500 mg given weekly, and the disease is mild to moderate AD. Thus, the ordinary artisan would at once envisage the instant claimed combination of elements (i.e. treating mild to moderate or moderate AD with a dose of 4500 mg of the antibody of SEQ ID NO: 5/9 to slow cognitive and memory decline or maintain cognitive function and memory). Alternatively, it would be obvious to do so based on the teachings of the cited reference.
Regarding the specific limitation of maintaining memory within 5 or 2.5 points, the prior art teaches weekly doses and maintaining cognitive function as measured by ADAS-Cog13 at least 13 weeks after treatment initiation by weekly dosing, i.e. maintaining the same ADAS-Cog 13 score after 13 doses. Maintaining the same score, as taught or suggested by the cited reference would be maintain within 5 or 2.5 points. Regarding the recitation of ADAS Cog 11, the reference teaches maintenance of memory and cognitive capacity as measured by ADAS-Cog-13, which includes 13 items (see page 19, in particular). This would inherently encompass the 11 item ADAS Cog.
Additionally, the function of maintaining ADAS-Cog11 score after a certain number of doses would also merely be inherent or latent properties of the treatment method of the prior art, which is identical to the claimed method. Regarding the other limitations of the present claim regarding slowing of decline in language capacity, praxis, or adverse events, these would also be inherent properties of the treatment method of the prior art, which is identical to the claimed method.
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 1-14 and 77-82 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,112,990, or 10,336,819, or 10,329,344, in view of WO 2018/183175. The patents claim a tau humanized monoclonal antibody with a VH of SEQ ID NO: 340 and a VL of SEQ ID NO: 341, which is identical to SEQ ID NO: 5 and 9 of the instant application and comprises CDRS of SEQ ID NO: 1-3 and 6-8 of the instant application, the same mutations, and IgG4, i.e. semorinemab. The antibodies are the same as those disclosed in WO 2018/183175, and the treatment method of the instant claims would be obvious based on the teachings of WO 2018/183175 for the same reason set forth above.
Claims 1-14 and 77-82 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27, 35, 54, 56-59, 61-63, and 68 of copending Application No. 19/183,131.
The ‘131 application claims a method of treating a tauopathy comprising administering to an individual with a tauopathy a 4500 mg dose of an anti-tau humanized antibody comprising CDRS of SEQ ID NO: 20-25, which are identical to SEQ ID NO: 2-4 and 6-8 of the instant application. The ‘131 application claims that the tauopathy is mild to moderate or moderate AD, and that the method slows or retains memory capacity, function or cognitive function in the individual as assessed by the ADAS-Cog13 scale at least 13 weeks after treatment. The ‘131 application claims that the antibody comprises SEQ ID NO: 18 and 19, which are identical to SEQ ID NO: 5 and 9 of the instant application, and that he antibody is an IgG4 with the same mutations of the instant claims, i.e. semorinemab. Any other differences are merely inherent or latent properties for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 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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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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