Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
2. The amendment filed 07/24/2026 is acknowledged and has been entered.
Claims 1, 4, 6-7 and 13 have been amended. Claims 2-3, 5, 8 and 14-17 have been cancelled. New claims 21-24 have been added.
Claims 1, 4, 6-7, 9-13 and 18-24 are pending in the application. Claims 10-12, 18-20 and 22-24 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/09/2026.
4. Claims 1, 4, 6-7, 9, 13 and 21 have been examined.
Grounds of Objection and Rejection Withdrawn
5. Unless specifically reiterated below, Applicant’s amendment and/or arguments have obviated or rendered moot the grounds of objection and rejection set forth in the previous Office action mailed 03/25/2026.
Grounds of Rejection Maintained
Double Patenting
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
7. Claims 1, 4, 6-7, 9, 13 and 21 remain/are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of copending Application No. 18/284209. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1, 4, 6-7, 9, 13 and 21 are herein drawn to an isolated monoclonal antibody or antigen-binding fragment thereof comprising immunoglobulin heavy chain HCDR1, HCDR2 and HCDR3 having the polypeptide sequences of SEQ ID NOs: 14, 15 and 16, respectively; and immunoglobulin light chain LCDR1, LCDR2 and LCDR3 having the polypeptide sequences of SEQ ID NOs: 17,18 and 19, respectively, wherein the isolated monoclonal antibody or antigen-binding fragment thereof binds to a tau protein, wherein the antibody comprising a heavy chain variable region having the polypeptide sequence of SEQ ID NO: 12,and a light chain variable region having the polypeptide sequence of SEQ ID NO: 13.
Claims 1-6 of copending Application No. 18/284209 are drawn to an isolated humanized antibody or antigen-binding fragment thereof, comprising a heavy chain variable region having the polypeptide sequence of SEQ ID NO: 12, and a light chain variable region having the polypeptide sequence of SEQ ID NO: 13.
The SEQ ID NOs: 12-13 of copending Application No. 18/284209 are 100% identical with the instant claimed SEQ ID NOs: 12-13; see below sequences alignment.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
The Applicant’s arguments:
Since the rejections are only provisional at this stage, Applicant defers substantively addressing the obvious type double patenting rejection at this stage of prosecution. However, in the event that the nonstatutory double patenting rejection is maintained, Applicant reserves the right to argue against the rejection, amend or cancel the pending claims, or file a Terminal Disclaimer, once the rejection is no longer provisional.
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
Applicant has not filled an appropriate terminal disclaimer or overcome the rejection by a specific amendment or argument; therefore, the rejection is maintained for the reasons of record.
Conclusion
8. No claim is allowed.
9. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YAN XIAO/Primary Examiner, Art Unit 1642
Sequences alignment
US-18-284-209-12
Sequence 12, US/18284209
Publication No. US20240166731A1
GENERAL INFORMATION
APPLICANT: Janssen Biotech, Inc.
TITLE OF INVENTION: HUMANIZED ANTIBODIES AGAINST PAIRED HELICAL FILAMENT TAU AND USES
TITLE OF INVENTION: THEREOF
FILE REFERENCE: 065768.11772/98US2
CURRENT APPLICATION NUMBER: US/18/284,209
CURRENT FILING DATE: 2023-09-26
NUMBER OF SEQ ID NOS: 62
SEQ ID NO 12
LENGTH: 115
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PT1B901 VH
Query Match 100.0%; Score 616; Length 115;
Best Local Similarity 100.0%;
Matches 115; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCKASGYTFTSYWITWVRQAPGQGLEWMGDIHPGRGSTKY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCKASGYTFTSYWITWVRQAPGQGLEWMGDIHPGRGSTKY 60
Qy 61 AQKLQGRVTLTTDTSTSTAYMELRSLRSDDTAVYYCARRWGFDYWGQGTLVTVSS 115
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AQKLQGRVTLTTDTSTSTAYMELRSLRSDDTAVYYCARRWGFDYWGQGTLVTVSS 115
US-18-284-209-13
Sequence 13, US/18284209
Publication No. US20240166731A1
GENERAL INFORMATION
APPLICANT: Janssen Biotech, Inc.
TITLE OF INVENTION: HUMANIZED ANTIBODIES AGAINST PAIRED HELICAL FILAMENT TAU AND USES
TITLE OF INVENTION: THEREOF
FILE REFERENCE: 065768.11772/98US2
CURRENT APPLICATION NUMBER: US/18/284,209
CURRENT FILING DATE: 2023-09-26
NUMBER OF SEQ ID NOS: 62
SEQ ID NO 13
LENGTH: 112
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: PT1B901 VL
Query Match 100.0%; Score 579; Length 112;
Best Local Similarity 100.0%;
Matches 112; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIVITQTPLSLPVTPGEPASISCRSSKSLLYKDLKTYLNWFLQKPGQSPQLLIYLMSTRA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIVITQTPLSLPVTPGEPASISCRSSKSLLYKDLKTYLNWFLQKPGQSPQLLIYLMSTRA 60
Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCQQLVDYPLTFGQGTKLEIK 112
||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCQQLVDYPLTFGQGTKLEIK 112
