Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
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
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
3. Applicant’s amendment filed March 23, 2026 is acknowledged. Claims 1-7, 9, 15-17, 20-23, 27-30 and 34-45 are canceled. Claims 10-11 and 18-19 are amended. Claims 8,10-14, 18-19, 24-26, 31-33 and 46-51 are pending in this application. Claims 31-33 and 50-51 are withdrawn without traverse (filed 01/23/2025) from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 23, 2025.
4. Claims 8,10-14, 18-19, 24-26 and 46-49 are under examination with respect to antibody 420845, and SEQ ID NOs: 7, 26, 36 for LCDRs1-3, SEQ ID NOs: 88, 116 and 171 for HCDRs 1-3, SEQ ID NOs: 54 and 203 for VL and VH, and SEQ ID NOs: 506 and 522 for light chain and heavy chain respectively in this office action.
5. The request for rejoinder of method claims on p. 7-8 of the response is moot because instant claims are not allowable for the reasons set forth below.
6. Applicant’s arguments filed on March 23, 2026 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections/Objections Withdrawn
7. The rejection of claims 10-11 under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (US9365653) is withdrawn in response to Applicant’s amendment to the claims.
The rejection of claims 10-11 on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of US Patent No.9365653 or claim 20 of U.S. Patent No. 9676851 is withdrawn in response to Applicant’s amendment to the claims.
New Grounds of Rejection Necessitated by the Amendment
The following rejections are new grounds of rejections necessitated by the amendment filed on March 23, 2026.
Double Patenting
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.
Claims 8,10-14, 18-19, 26 and 46-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-10, 15-17, 28, 71, 73 and 75 of copending Application No. 17/621189. Although the claims at issue are not identical, they are not patentably distinct from each other because the anti-CGRP receptor and anti-PAC1 receptor bispecific antibody recited in claims 7-10, 15-17, 28, 71, 73 and 75 of Application No. 17/621189 (the ‘189 Application) comprises sequences for VL and VH or sequences for CDRL1-3 and CDRH1-3 that are identical to the sequences of VL and VH or CDRL1-3 and CDRH1-3 of the anti-human PAC1 receptor antibody recited in instant claims and thus anticipate instant claims.
The sequences of SEQ ID NOs: 131, 141 and 142 for CDRL1-3 respectively recited in (a) of claim 7 of the ‘189 Application are identical to instant SEQ ID NOs:7, 26 and 36 for CDRL1-3 respectively recited in claims 8 and 10-11 of the instant application.
The sequences of SEQ ID NOs: 157, 165 and 195 for CDRH1-3 respectively recited in (a) of claim 7 and claim 71 of the ‘189 Application are identical to instant SEQ ID NOs:88, 116 and 171 for CDRH1-3 respectively recited in claims 8 and 10-11 of the instant application
The sequence of SEQ ID NO: 147 for VL recited in claim 8, (a) of claim 10 and claim 73 of the ‘189 Application is identical to instant SEQ ID NO: 54 for VL recited in claims 10-12.
The sequence of SEQ ID NO: 200 for VH recited in claim 8, (a) of claim 10 and claim 73 of the ‘189 Application is identical to instant SEQ ID NO: 203 for VH recited in claims 10-12.
The sequence of SEQ ID NO: 232 for light chain recited in claim 15; (i) of claim 17; (b), (d), (g)-(j) of claim 28 and claim 75 of the ‘189 Application is identical to instant SEQ ID NO:54 for VL recited in claims 10-12.
The sequences of SEQ ID NO: 243, 244, 245, 246, 247, 248 or 249 for heavy chain recited in claim 16; (i) of claim 17; (b), (d), (g)-(j) of claim 28 and claim 75 of the ‘189 Application are identical to instant SEQ ID NO: 203 for VH recited in claims 10-12.
Therefore, claims 8,10-14, 18-19, 26 and 46-49 of the instant Application are not patentably distinct from claims 7-10, 15-17, 28, 71, 73 and 75 of the ‘189 Application, because claims 8,10-14, 18-19, 26 and 46-49 of the instant Application are anticipated by claims 7-10, 15-17, 28, 71, 73 and 75 of the ‘189 Application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The sequence search results disclose as follows:
CDRL1-3
SEQ ID NO:7-SEQ ID NO:26-SEQ ID NO:36
US-17-621-189-232
Sequence 232, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 232
LENGTH: 214
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 81.4%; Score 108.3; Length 214;
Best Local Similarity 36.5%;
Matches 27; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASKSVGRSLH---------------YASQSLS--------------------------- 18
||||||||||| |||||||
Db 24 RASKSVGRSLHWYQQKPGQAPRLLIKYASQSLSGIPARFSGSGSGTDFTLTISSLEPEDF 83
Qy 19 -----HQSSRLPFT 27
|||||||||
Db 84 AVYYCHQSSRLPFT 97
SEQ ID NO:7
Sequence 131, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 131
LENGTH: 11
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 53; Length 11;
Best Local Similarity 100.0%;
Matches 11; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RASKSVGRSLH 11
|||||||||||
Db 1 RASKSVGRSLH 11
SEQ ID NO:26
Sequence 141, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 141
LENGTH: 7
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 32; Length 7;
Best Local Similarity 100.0%;
Matches 7; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 YASQSLS 7
|||||||
Db 1 YASQSLS 7
SEQ ID NO:36
Sequence 142, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 142
LENGTH: 9
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 48; Length 9;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 HQSSRLPFT 9
|||||||||
Db 1 HQSSRLPFT 9
VL
SEQ ID NO:54
Sequence 147, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 147
LENGTH: 107
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 552; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCRASKSVGRSLHWYQQKPGQAPRLLIKYASQSLSGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCRASKSVGRSLHWYQQKPGQAPRLLIKYASQSLSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCHQSSRLPFTFGPGTKVDIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCHQSSRLPFTFGPGTKVDIK 107
US-17-621-189-232
Sequence 232, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 232
LENGTH: 214
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 552; Length 214;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCRASKSVGRSLHWYQQKPGQAPRLLIKYASQSLSGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCRASKSVGRSLHWYQQKPGQAPRLLIKYASQSLSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCHQSSRLPFTFGPGTKVDIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCHQSSRLPFTFGPGTKVDIK 107
CDRH1-3
SEQ ID NO:88-SEQ ID NO:116-SEQ ID NO:171
US-17-621-189-246
Sequence 246, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 246
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 86.4%; Score 156.4; Length 450;
Best Local Similarity 41.8%;
Matches 33; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 RFAMH--------------VISYQGRNKYYAESVKG------------------------ 22
||||| |||||||||||||||||
Db 31 RFAMHWVRQAPGKGLEWVAVISYQGRNKYYAESVKGRFTISRDNSKNTLYLQMNSLRAED 90
Qy 23 --------GYDVLTGYPDY 33
|||||||||||
Db 91 TALFYCARGYDVLTGYPDY 109
SEQ ID NO:88
Sequence 157, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 157
LENGTH: 5
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 28; Length 5;
Best Local Similarity 100.0%;
Matches 5; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RFAMH 5
|||||
Db 1 RFAMH 5
SEQ ID NO:116
Sequence 165, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 165
LENGTH: 17
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 88; Length 17;
Best Local Similarity 100.0%;
Matches 17; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VISYQGRNKYYAESVKG 17
|||||||||||||||||
Db 1 VISYQGRNKYYAESVKG 17
SEQ ID NO:171
Sequence 195, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 195
LENGTH: 11
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 65; Length 11;
Best Local Similarity 100.0%;
Matches 11; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GYDVLTGYPDY 11
|||||||||||
Db 1 GYDVLTGYPDY 11
VH
SEQ ID NO:203
Sequence 200, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 200
LENGTH: 120
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 633; Length 120;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
US-17-621-189-246
Sequence 246, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 246
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 633; Length 450;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
US-17-621-189-245
Sequence 245, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 245
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 633; Length 450;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
US-17-621-189-244
Sequence 244, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 244
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 633; Length 450;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
US-17-621-189-243
Sequence 243, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 243
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 633; Length 450;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
US-17-621-189-249
Sequence 249, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 249
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 633; Length 450;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
US-17-621-189-248
Sequence 248, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 248
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 633; Length 450;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
US-17-621-189-247
Sequence 247, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 247
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 100.0%; Score 633; Length 450;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
Conclusion
Allowable Subject Matter
9. Claims 24-25 are allowable.
10. Claims 8,10-14, 18-19, 26 and 46-49 are rejected.
Heavy chain alignment
HC
SEQ ID NO:521(protein)
SEQ ID NO:554(DNA)
VH
SEQ ID NO:194(protein)
SEQ ID NO:367(DNA)
SEQ ID NO:521 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYIGGNKYY 60
SEQ ID NO:194 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYIGGNKYY 60
SEQ ID NO: 88 1 ------------------------------RFAMH------------------------- 5
SEQ ID NO:108 1 -------------------------------------------------VISYIGGNKYY 11
SEQ ID NO:171 --------------------------------------------------------------
SEQ ID NO:521 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
SEQ ID NO:194 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
SEQ ID NO: 88 ------------------------------------------------------------
SEQ ID NO:108 12 AESVKG------------------------------------------------------ 17
SEQ ID NO:171 1 --------------------------------------GYDVLTGYPDY----------- 11
SEQ ID NO:521 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
SEQ ID NO:521 181 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
SEQ ID NO:521 241 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
SEQ ID NO:521 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
SEQ ID NO:521 361 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 420
SEQ ID NO:521 421 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 450
Light chain alignment
LC
SEQ ID NO:506(protein)
SEQ ID NO:539(DNA)
VL
SEQ ID NO:54(protein)
SEQ ID NO:330(DNA)
SEQ ID NO:506 1 EIVLTQSPATLSLSPGERATLSCRASKSVGRSLHWYQQKPGQAPRLLIKYASQSLSGIPA 60
SEQ ID NO:54 1 EIVLTQSPATLSLSPGERATLSCRASKSVGRSLHWYQQKPGQAPRLLIKYASQSLSGIPA 60
SEQ ID NO:7 1 -----------------------RASKSVGRSLH-------------------------- 11
SEQ ID NO:26 1 -------------------------------------------------YASQSLS---- 7
SEQ ID NO:36 ------------------------------------------------------------
SEQ ID NO:506 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCHQSSRLPFTFGPGTKVDIKRTVAAPSVFIFPP 120
SEQ ID NO:54 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCHQSSRLPFTFGPGTKVDIK------------- 107
SEQ ID NO:7 ------------------------------------------------------------
SEQ ID NO:26 ------------------------------------------------------------
SEQ ID NO:36 1 ----------------------------HQSSRLPFT----------------------- 9
SEQ ID NO:506 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
SEQ ID NO:506 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Application No. 17/621189 under double patenting claim an anti-CGRP receptor/anti-PAC1 receptor bispecific antigen binding protein comprising SEQ ID NO:243, 244, 245, 246, 248 or 249 for heavy chain, which is 99.3% identical to instant SEQ ID NO:522; and SEQ ID NO:232 for light chain, which is 99.6% identical to instant SEQ ID NO:506 (see the sequence alignment below).
SEQ ID NO:522
US-17-621-189-243
Sequence 243, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 243
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 99.3%; Score 2393; Length 450;
Best Local Similarity 99.3%;
Matches 447; Conservative 0; Mismatches 3; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
Qy 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
Qy 181 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
||||| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GLYSLKSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
Qy 241 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
Qy 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
Qy 361 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 420
|||||||||||||||||||||||||||||||||| |||||||||||||||| ||||||||
Db 361 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYDTTPPVLDSDGSFFLYSDLTVDKSRW 420
Qy 421 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 450
||||||||||||||||||||||||||||||
Db 421 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 450
US-17-621-189-246
Sequence 246, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 246
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 99.1%; Score 2387; Length 450;
Best Local Similarity 98.9%;
Matches 445; Conservative 3; Mismatches 2; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
Qy 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
Qy 181 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
||||| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GLYSLKSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
Qy 241 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
Qy 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
Qy 361 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 420
||:|||||||||:|||||||||||||||||||||:|||||||||||||||| ||||||||
Db 361 MTENQVSLTCLVEGFYPSDIAVEWESNGQPENNYETTPPVLDSDGSFFLYSDLTVDKSRW 420
Qy 421 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 450
||||||||||||||||||||||||||||||
Db 421 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 450
US-17-621-189-245
Sequence 245, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 245
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 99.1%; Score 2387; Length 450;
Best Local Similarity 99.1%;
Matches 446; Conservative 0; Mismatches 4; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
Qy 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
Qy 181 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
||||| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GLYSLKSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
Qy 241 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
Qy 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
Qy 361 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 420
|||||||||||||||||||||||||||||||||| |||||||||||||||| ||||||||
Db 361 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYDTTPPVLDSDGSFFLYSDLTVDKSRW 420
Qy 421 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 450
||||||||||||||||||||| ||||||||
Db 421 QQGNVFSCSVMHEALHNHYTQDSLSLSPGK 450
US-17-621-189-244
Sequence 244, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 244
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 99.1%; Score 2387; Length 450;
Best Local Similarity 99.1%;
Matches 446; Conservative 0; Mismatches 4; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
Qy 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
Qy 181 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
||||| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GLYSLKSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
Qy 241 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
Qy 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
Qy 361 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 420
|||||||||||| ||||||||||||||||||||| |||||||||||||||| ||||||||
Db 361 MTKNQVSLTCLVDGFYPSDIAVEWESNGQPENNYDTTPPVLDSDGSFFLYSDLTVDKSRW 420
Qy 421 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 450
||||||||||||||||||||||||||||||
Db 421 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 450
US-17-621-189-249
Sequence 249, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 249
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 98.5%; Score 2372; Length 450;
Best Local Similarity 98.2%;
Matches 442; Conservative 4; Mismatches 4; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
Qy 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
Qy 181 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
||||| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GLYSLKSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
Qy 241 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
|||||||||||||| |:| |||||||||||||||||||||||||||||||||||||||||
Db 241 PSVFLFPPKPKDTLYITREPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
Qy 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
Qy 361 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 420
||:|||||||||:|||||||||||||||||||||:|||||||||||||||| ||||||||
Db 361 MTENQVSLTCLVEGFYPSDIAVEWESNGQPENNYETTPPVLDSDGSFFLYSDLTVDKSRW 420
Qy 421 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 450
||||||||||||||||||||||||||||||
Db 421 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 450
US-17-621-189-248
Sequence 248, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 248
LENGTH: 450
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 98.5%; Score 2372; Length 450;
Best Local Similarity 98.4%;
Matches 443; Conservative 1; Mismatches 6; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSRFAMHWVRQAPGKGLEWVAVISYQGRNKYY 60
Qy 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AESVKGRFTISRDNSKNTLYLQMNSLRAEDTALFYCARGYDVLTGYPDYWGQGTLVTVSS 120
Qy 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180
Qy 181 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
||||| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GLYSLKSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 240
Qy 241 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
|||||||||||||| |:| |||||||||||||||||||||||||||||||||||||||||
Db 241 PSVFLFPPKPKDTLYITREPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYG 300
Qy 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 STYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 360
Qy 361 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 420
|||||||||||||||||||||||||||||||||| |||||||||||||||| ||||||||
Db 361 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYDTTPPVLDSDGSFFLYSDLTVDKSRW 420
Qy 421 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 450
||||||||||||||||||||| ||||||||
Db 421 QQGNVFSCSVMHEALHNHYTQDSLSLSPGK 450
SEQ ID NO:506
US-17-621-189-232
Sequence 232, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 232
LENGTH: 214
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 99.6%; Score 1101; Length 214;
Best Local Similarity 99.5%;
Matches 213; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCRASKSVGRSLHWYQQKPGQAPRLLIKYASQSLSGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCRASKSVGRSLHWYQQKPGQAPRLLIKYASQSLSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCHQSSRLPFTFGPGTKVDIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCHQSSRLPFTFGPGTKVDIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||| ||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLESTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
US-17-621-189-240
Sequence 240, US/17621189
Publication No. US20220363770A1
GENERAL INFORMATION
APPLICANT: AMGEN INC.
TITLE OF INVENTION: ANTI-CGRP RECEPTOR/ANTI-PAC1 RECEPTOR BISPECIFIC ANTIGEN BINDING
TITLE OF INVENTION: PROTEINS
FILE REFERENCE: A-2314-US-PCT
CURRENT APPLICATION NUMBER: US/17/621,189
CURRENT FILING DATE: 2021-12-20
PRIOR APPLICATION NUMBER: 62/868,557
PRIOR FILING DATE: 2019-06-28
PRIOR APPLICATION NUMBER: PCT/US2020/039940
PRIOR FILING DATE: 2020-06-26
NUMBER OF SEQ ID NOS: 477
SEQ ID NO 240
LENGTH: 214
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic polypeptide
Query Match 97.4%; Score 1076; Length 214;
Best Local Similarity 97.2%;
Matches 208; Conservative 2; Mismatches 4; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCRASKSVGRSLHWYQQKPGQAPRLLIKYASQSLSGIPA 60
|||||||||||||||||||||||||||:| :||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCRASKAVWHNLHWYQQKPGQAPRLLIKYASQSLSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCHQSSRLPFTFGPGTKVDIKRTVAAPSVFIFPP 120
|||||||||||||||||||||||||||||||| |||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCHQSSMLPFTFGPGTKVDIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||| ||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLESTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
12. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chang-Yu Wang whose telephone number is (571)272-4521. The examiner can normally be reached on Monday-Thursday, 7:00am-5:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker, can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Chang-Yu Wang
March 31, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
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