DETAILED ACTION
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 .
Priority
1. Application claims priority to provisional application 63/277,885 filed on 11/10/2021. Priority is granted to the provisional application 63/277,885 and the effective filing date of 11/10/2021.
Information Disclosure Statement
2. The information disclosure statements (IDS) submitted on 1/31/2025, 5/19/2025, 8/28/2025, 14/24/2025, and 5/30/2026 were filed after the mailing date of the Non-Final Office Action on 1/15/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
3. The Amendment filed on July 15, 2025 in response to the Office Action of January 15, 2025 is acknowledged and has been entered. Claims 1-8, 10-14, 16-21, 23-24, and 26-31 are currently pending and under examination in this action.
Rejections Withdrawn
4. Applicant’s arguments with respect to claim(s) 1-8, 10-14, 16-21, 23, 24, and 26-31 as unpatentable under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
New Rejections
(Based on New Considerations)
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. Claims 1-8, 10-14, 16-21, 23-24, 26-27, and 30-31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Adams (WO 2021/228783 A1, effectively filed 5/11/2020).
The applied reference has a common Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Adams discloses a bispecific BCMA/CD3 antibody comprising a first heavy chain comprising a HC1 variable region with the HCDR1, HCDR2, and HCDR3 of SEQ ID NOs: 1, 2, and 3, respectively, and represented by the variable region of SEQ ID NO: 7 (SEQ ID NO: 10, see alignment below), and the entire HC1 of SEQ ID NO: 9 (SEQ ID NO: 12, see alignments below); a first light chain comprising a LC1 variable region with the LCDR1, LCDR2, and LCDR3 of SEQ ID NOs: 4, 5, and 6, respectively, and represented by the variable region of SEQ ID NO: 8 (SEQ ID NO: 11, see alignments below), and the entire LC1 of SEQ ID NO: 10 (SEQ ID NO: 13, see alignments below); a second heavy chain comprising a HC2 variable region with the HCDR1, HCDR2, and HCDR3 of SEQ ID NOs: 11, 12, and 13, respectively, and represented by the variable region of SEQ ID NO: 17 (SEQ ID NO: 20, see alignment below), and the entire HC2 of SEQ ID NO: 19 (SEQ ID NO: 22, see alignments below); and a second light chain comprising a LC2 variable region with the LCDR1, LCDR2, and LCDR3 of SEQ ID NOs: 14, 15, and 16, respectively, and represented by the variable region of SEQ ID NO: 18 (SEQ ID NO: 21, see alignments below), and the entire LC2 of SEQ ID NO: 20 (SEQ ID NO: 23, see alignments below).
Adams teaches the bispecific BCMA/CD3 antibody can be formulated as a pharmaceutical composition comprising about 1 mg/mL to about 200 mg/mL antibody. (See Adams, pg. 21 lines 7-8). Adams teaches that this concentration range can be part of a formulation that comprises the BCMA/CD3 antibody, such as teclistamab, and further comprises 10-15 mM sodium acetate, 8% (w/v) sucrose, 0.04% (w/v) PS20, and 20 µg/mL EDTA at a pH of 5.2. (See Adams, pg. 22 lines 13-15).
Adams teaches that the bispecific BCMA/CD3 antibody can be used to treat cancer and can be administered subcutaneously. (See Adams, abstract, also pg. 22 lines 23-24).
SEQ ID NOs: 1, 2, and 3 are 100% disclosed in SEQ ID NO: 10 (Adams):
WO2021228783-A1.
XX
CC PD 18-NOV-2021.
XX
CC PF 10-MAY-2021; 2021WO-EP062364.
XX
PR 11-MAY-2020; 2020US-0023092P.
PR 13-MAY-2020; 2020US-0024209P.
PR 10-MAR-2021; 2021US-0159303P.
XX
CC PA (JANC ) JANSSEN PHARM NV.
XX
CC PI Adams H, Goldberg J, Banerjee A, Stephenson T, Verona R;
CC PI Girgis S, Lin SXW;
XX
DR WPI; 2021-D0730K/097.
XX
CC PT Treating cancer i.e. multiple myeloma in subject, comprises administering
CC PT BCMA and CD3 bispecific antibody or antigen binding fragment to subject,
CC PT where subject is relapsed to treatment with prior anti-cancer treatment.
XX
CC PS Claim 3; SEQ ID NO 10; 119pp; English.
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 165.4 87.1 121 BGZ83573 -- 18 Anti-BCMA antibody BCMB69 VH domain, SEQ 29.
ALIGNMENT:
Query Match 87.1%; Score 165.4; Length 121;
Best Local Similarity 42.5%;
Matches 34; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 SGSYFWG--------------SIYYSGITYYNPSLKS----------------------- 23
||||||| ||||||||||||||||
Db 31 SGSYFWGWIRQPPGKGLEWIGSIYYSGITYYNPSLKSRVTISVDTSKNQFSLKLSSVTAA 90
Qy 24 ---------HDGAVAGLFDY 34
|||||||||||
Db 91 DTAVYYCARHDGAVAGLFDY 110
SEQ ID NOs: 4, 5, and 6 are 100% disclosed in SEQ ID NO: 11 (Adams):
WO2021228783-A1.
XX
CC PD 18-NOV-2021.
XX
CC PF 10-MAY-2021; 2021WO-EP062364.
XX
PR 11-MAY-2020; 2020US-0023092P.
PR 13-MAY-2020; 2020US-0024209P.
PR 10-MAR-2021; 2021US-0159303P.
XX
CC PA (JANC ) JANSSEN PHARM NV.
XX
CC PI Adams H, Goldberg J, Banerjee A, Stephenson T, Verona R;
CC PI Girgis S, Lin SXW;
XX
DR WPI; 2021-D0730K/097.
XX
CC PT Treating cancer i.e. multiple myeloma in subject, comprises administering
CC PT BCMA and CD3 bispecific antibody or antigen binding fragment to subject,
CC PT where subject is relapsed to treatment with prior anti-cancer treatment.
XX
CC PS Claim 3; SEQ ID NO 11; 119pp; English.
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
48 132.3 84.3 111 BGZ83574 -- 8 Anti-BCMA antibody BCMB69 VL domain, SEQ 30.
ALIGNMENT:
Query Match 84.3%; Score 132.3; Length 111;
Best Local Similarity 38.2%;
Matches 29; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 GGNNIGSKSVH---------------DDSDRPS--------------------------- 18
||||||||||| |||||||
Db 23 GGNNIGSKSVHWYQQPPGQAPVVVVYDDSDRPSGIPERFSGSNSGNTATLTISRVEAGDE 82
Qy 19 -----QVWDSSSDHVV 29
|||||||||||
Db 83 AVYYCQVWDSSSDHVV 98
SEQ ID NOs: 11, 12, and 13 are 100% disclosed in SEQ ID NO: 20 (Adams):
PNG
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361
476
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Greyscale
PNG
media_image2.png
319
772
media_image2.png
Greyscale
SEQ ID NOs: 14, 15, and 16 are 100% disclosed in SEQ ID NO: 21 (Adams):
WO2021228783-A1.
XX
CC PD 18-NOV-2021.
XX
CC PF 10-MAY-2021; 2021WO-EP062364.
XX
PR 11-MAY-2020; 2020US-0023092P.
PR 13-MAY-2020; 2020US-0024209P.
PR 10-MAR-2021; 2021US-0159303P.
XX
CC PA (JANC ) JANSSEN PHARM NV.
XX
CC PI Adams H, Goldberg J, Banerjee A, Stephenson T, Verona R;
CC PI Girgis S, Lin SXW;
XX
DR WPI; 2021-D0730K/097.
XX
CC PT Treating cancer i.e. multiple myeloma in subject, comprises administering
CC PT BCMA and CD3 bispecific antibody or antigen binding fragment to subject,
CC PT where subject is relapsed to treatment with prior anti-cancer treatment.
XX
CC PS Claim 3; SEQ ID NO 21; 119pp; English.
XX
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
196 137.3 84.8 112 BGZ83584 -- 12 Anti-BCMA antibody CD3BB219 VL domain, SEQ 40.
ALIGNMENT:
Query Match 84.8%; Score 137.3; Length 112;
Best Local Similarity 39.0%;
Matches 30; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RSSTGAVTTSNYAN---------------GTNKRAP------------------------ 21
|||||||||||||| |||||||
Db 23 RSSTGAVTTSNYANWVQQKPGQAPRGLIGGTNKRAPGTPARFSGSLLGGKAALTLSGVQP 82
Qy 22 --------ALWYSNLWV 30
|||||||||
Db 83 EDEAEYYCALWYSNLWV 99
SEQ ID NO: 7 is 100% identical to SEQ ID NO: 10 (Adams):
WO2021228783-A1.
XX
CC PD 18-NOV-2021.
XX
CC PF 10-MAY-2021; 2021WO-EP062364.
XX
PR 11-MAY-2020; 2020US-0023092P.
PR 13-MAY-2020; 2020US-0024209P.
PR 10-MAR-2021; 2021US-0159303P.
XX
CC PA (JANC ) JANSSEN PHARM NV.
XX
CC PI Adams H, Goldberg J, Banerjee A, Stephenson T, Verona R;
CC PI Girgis S, Lin SXW;
XX
DR WPI; 2021-D0730K/097.
XX
CC PT Treating cancer i.e. multiple myeloma in subject, comprises administering
CC PT BCMA and CD3 bispecific antibody or antigen binding fragment to subject,
CC PT where subject is relapsed to treatment with prior anti-cancer treatment.
XX
CC PS Claim 3; SEQ ID NO 10; 119pp; English.
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 638 100.0 121 BGZ83573 -- 18 Anti-BCMA antibody BCMB69 VH domain, SEQ 29.
ALIGNMENT:
Query Match 100.0%; Score 638; Length 121;
Best Local Similarity 100.0%;
Matches 121; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QLQLQESGPGLVKPSETLSLTCTVSGGSISSGSYFWGWIRQPPGKGLEWIGSIYYSGITY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QLQLQESGPGLVKPSETLSLTCTVSGGSISSGSYFWGWIRQPPGKGLEWIGSIYYSGITY 60
Qy 61 YNPSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARHDGAVAGLFDYWGQGTLVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YNPSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARHDGAVAGLFDYWGQGTLVTVS 120
Qy 121 S 121
|
Db 121 S 121
SEQ ID NO: 8 is 100% identical to SEQ ID NO: 11 (Adams):
WO2021228783-A1.
XX
CC PD 18-NOV-2021.
XX
CC PF 10-MAY-2021; 2021WO-EP062364.
XX
PR 11-MAY-2020; 2020US-0023092P.
PR 13-MAY-2020; 2020US-0024209P.
PR 10-MAR-2021; 2021US-0159303P.
XX
CC PA (JANC ) JANSSEN PHARM NV.
XX
CC PI Adams H, Goldberg J, Banerjee A, Stephenson T, Verona R;
CC PI Girgis S, Lin SXW;
XX
DR WPI; 2021-D0730K/097.
XX
CC PT Treating cancer i.e. multiple myeloma in subject, comprises administering
CC PT BCMA and CD3 bispecific antibody or antigen binding fragment to subject,
CC PT where subject is relapsed to treatment with prior anti-cancer treatment.
XX
CC PS Claim 3; SEQ ID NO 11; 119pp; English.
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 592 100.0 111 BGZ83574 -- 8 Anti-BCMA antibody BCMB69 VL domain, SEQ 30.
ALIGNMENT:
Query Match 100.0%; Score 592; Length 111;
Best Local Similarity 100.0%;
Matches 111; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SYVLTQPPSVSVAPGQTARITCGGNNIGSKSVHWYQQPPGQAPVVVVYDDSDRPSGIPER 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 SYVLTQPPSVSVAPGQTARITCGGNNIGSKSVHWYQQPPGQAPVVVVYDDSDRPSGIPER 60
Qy 61 FSGSNSGNTATLTISRVEAGDEAVYYCQVWDSSSDHVVFGGGTKLTVLGQP 111
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 FSGSNSGNTATLTISRVEAGDEAVYYCQVWDSSSDHVVFGGGTKLTVLGQP 111
SEQ ID NO: 9 is 100% identical to SEQ ID NO: 12 (Adams):
WO2021228783-A1.
XX
CC PD 18-NOV-2021.
XX
CC PF 10-MAY-2021; 2021WO-EP062364.
XX
PR 11-MAY-2020; 2020US-0023092P.
PR 13-MAY-2020; 2020US-0024209P.
PR 10-MAR-2021; 2021US-0159303P.
XX
CC PA (JANC ) JANSSEN PHARM NV.
XX
CC PI Adams H, Goldberg J, Banerjee A, Stephenson T, Verona R;
CC PI Girgis S, Lin SXW;
XX
DR WPI; 2021-D0730K/097.
XX
CC PT Treating cancer i.e. multiple myeloma in subject, comprises administering
CC PT BCMA and CD3 bispecific antibody or antigen binding fragment to subject,
CC PT where subject is relapsed to treatment with prior anti-cancer treatment.
XX
CC PS Claim 5; SEQ ID NO 12; 119pp; English.
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 2382 100.0 448 BDO14309 -- 17 Anti-CD3/BCMA bispecific antibody heavy chain, SEQ ID 65.
ALIGNMENT:
Query Match 100.0%; Score 2382; Length 448;
Best Local Similarity 100.0%;
Matches 448; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QLQLQESGPGLVKPSETLSLTCTVSGGSISSGSYFWGWIRQPPGKGLEWIGSIYYSGITY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QLQLQESGPGLVKPSETLSLTCTVSGGSISSGSYFWGWIRQPPGKGLEWIGSIYYSGITY 60
Qy 61 YNPSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARHDGAVAGLFDYWGQGTLVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YNPSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARHDGAVAGLFDYWGQGTLVTVS 120
Qy 121 SASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS 180
Qy 181 SGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEAAGGPS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEAAGGPS 240
Qy 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNST 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNST 300
Qy 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMT 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMT 360
Qy 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQE 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQE 420
Qy 421 GNVFSCSVMHEALHNHYTQKSLSLSLGK 448
||||||||||||||||||||||||||||
Db 421 GNVFSCSVMHEALHNHYTQKSLSLSLGK 448
SEQ ID NO: 10 is 100% identical to SEQ ID NO: 13 (Adams):
WO2021228783-A1.
XX
CC PD 18-NOV-2021.
XX
CC PF 10-MAY-2021; 2021WO-EP062364.
XX
PR 11-MAY-2020; 2020US-0023092P.
PR 13-MAY-2020; 2020US-0024209P.
PR 10-MAR-2021; 2021US-0159303P.
XX
CC PA (JANC ) JANSSEN PHARM NV.
XX
CC PI Adams H, Goldberg J, Banerjee A, Stephenson T, Verona R;
CC PI Girgis S, Lin SXW;
XX
DR WPI; 2021-D0730K/097.
XX
CC PT Treating cancer i.e. multiple myeloma in subject, comprises administering
CC PT BCMA and CD3 bispecific antibody or antigen binding fragment to subject,
CC PT where subject is relapsed to treatment with prior anti-cancer treatment.
XX
CC PS Claim 5; SEQ ID NO 13; 119pp; English.
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 1130 100.0 214 BDO14320 -- 20 Anti-BCMA mAb light chain, SEQ ID 76.
ALIGNMENT:
Query Match 100.0%; Score 1130; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SYVLTQPPSVSVAPGQTARITCGGNNIGSKSVHWYQQPPGQAPVVVVYDDSDRPSGIPER 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 SYVLTQPPSVSVAPGQTARITCGGNNIGSKSVHWYQQPPGQAPVVVVYDDSDRPSGIPER 60
Qy 61 FSGSNSGNTATLTISRVEAGDEAVYYCQVWDSSSDHVVFGGGTKLTVLGQPKAAPSVTLF 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 FSGSNSGNTATLTISRVEAGDEAVYYCQVWDSSSDHVVFGGGTKLTVLGQPKAAPSVTLF 120
Qy 121 PPSSEELQANKATLVCLISDFYPGAVTVAWKGDSSPVKAGVETTTPSKQSNNKYAASSYL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 PPSSEELQANKATLVCLISDFYPGAVTVAWKGDSSPVKAGVETTTPSKQSNNKYAASSYL 180
Qy 181 SLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS 214
||||||||||||||||||||||||||||||||||
Db 181 SLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS 214
SEQ ID NO: 17 is 100% identical to SEQ ID NO: 20 (Adams):
WO2021228783-A1.
XX
CC PD 18-NOV-2021.
XX
CC PF 10-MAY-2021; 2021WO-EP062364.
XX
PR 11-MAY-2020; 2020US-0023092P.
PR 13-MAY-2020; 2020US-0024209P.
PR 10-MAR-2021; 2021US-0159303P.
XX
CC PA (JANC ) JANSSEN PHARM NV.
XX
CC PI Adams H, Goldberg J, Banerjee A, Stephenson T, Verona R;
CC PI Girgis S, Lin SXW;
XX
DR WPI; 2021-D0730K/097.
XX
CC PT Treating cancer i.e. multiple myeloma in subject, comprises administering
CC PT BCMA and CD3 bispecific antibody or antigen binding fragment to subject,
CC PT where subject is relapsed to treatment with prior anti-cancer treatment.
XX
CC PS Claim 3; SEQ ID NO 20; 119pp; English.
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 667 100.0 125 BCM99763 -- 33 Anti-CD3 humanized antibody CD3H141 VH, SEQ ID 184.
ALIGNMENT:
Query Match 100.0%; Score 667; Length 125;
Best Local Similarity 100.0%;
Matches 125; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFNTYAMNWVRQAPGKGLEWVARIRSKYNNYAT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFNTYAMNWVRQAPGKGLEWVARIRSKYNNYAT 60
Qy 61 YYAASVKGRFTISRDDSKNSLYLQMNSLKTEDTAVYYCARHGNFGNSYVSWFAYWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YYAASVKGRFTISRDDSKNSLYLQMNSLKTEDTAVYYCARHGNFGNSYVSWFAYWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
SEQ ID NO: 18 is 100% identical to SEQ ID NO: 21 (Adams):
WO2021228783-A1.
XX
CC PD 18-NOV-2021.
XX
CC PF 10-MAY-2021; 2021WO-EP062364.
XX
PR 11-MAY-2020; 2020US-0023092P.
PR 13-MAY-2020; 2020US-0024209P.
PR 10-MAR-2021; 2021US-0159303P.
XX
CC PA (JANC ) JANSSEN PHARM NV.
XX
CC PI Adams H, Goldberg J, Banerjee A, Stephenson T, Verona R;
CC PI Girgis S, Lin SXW;
XX
DR WPI; 2021-D0730K/097.
XX
CC PT Treating cancer i.e. multiple myeloma in subject, comprises administering
CC PT BCMA and CD3 bispecific antibody or antigen binding fragment to subject,
CC PT where subject is relapsed to treatment with prior anti-cancer treatment.
XX
CC PS Claim 3; SEQ ID NO 21; 119pp; English.
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 594 100.0 112 BGZ83584 -- 12 Anti-BCMA antibody CD3BB219 VL domain, SEQ 40.
ALIGNMENT:
Query Match 100.0%; Score 594; Length 112;
Best Local Similarity 100.0%;
Matches 112; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QTVVTQEPSLTVSPGGTVTLTCRSSTGAVTTSNYANWVQQKPGQAPRGLIGGTNKRAPGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QTVVTQEPSLTVSPGGTVTLTCRSSTGAVTTSNYANWVQQKPGQAPRGLIGGTNKRAPGT 60
Qy 61 PARFSGSLLGGKAALTLSGVQPEDEAEYYCALWYSNLWVFGGGTKLTVLGQP 112
||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PARFSGSLLGGKAALTLSGVQPEDEAEYYCALWYSNLWVFGGGTKLTVLGQP 112
SEQ ID NO: 19 is 100% identical to SEQ ID NO: 22 (Adams):
WO2021228783-A1.
XX
CC PD 18-NOV-2021.
XX
CC PF 10-MAY-2021; 2021WO-EP062364.
XX
PR 11-MAY-2020; 2020US-0023092P.
PR 13-MAY-2020; 2020US-0024209P.
PR 10-MAR-2021; 2021US-0159303P.
XX
CC PA (JANC ) JANSSEN PHARM NV.
XX
CC PI Adams H, Goldberg J, Banerjee A, Stephenson T, Verona R;
CC PI Girgis S, Lin SXW;
XX
DR WPI; 2021-D0730K/097.
XX
CC PT Treating cancer i.e. multiple myeloma in subject, comprises administering
CC PT BCMA and CD3 bispecific antibody or antigen binding fragment to subject,
CC PT where subject is relapsed to treatment with prior anti-cancer treatment.
XX
CC PS Claim 5; SEQ ID NO 22; 119pp; English.
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 2409 100.0 452 BCM99789 -- 37 Anti-CD123xCD3 bispecific antibody heavy chain 1, SEQ ID 210.
ALIGNMENT:
Query Match 100.0%; Score 2409; Length 452;
Best Local Similarity 100.0%;
Matches 452; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFNTYAMNWVRQAPGKGLEWVARIRSKYNNYAT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFNTYAMNWVRQAPGKGLEWVARIRSKYNNYAT 60
Qy 61 YYAASVKGRFTISRDDSKNSLYLQMNSLKTEDTAVYYCARHGNFGNSYVSWFAYWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YYAASVKGRFTISRDDSKNSLYLQMNSLKTEDTAVYYCARHGNFGNSYVSWFAYWGQGTL 120
Qy 121 VTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPA 180
Qy 181 VLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEAA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEAA 240
Qy 241 GGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQ 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQ 300
Qy 301 FNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQ 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 FNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQ 360
Qy 361 EEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFLLYSKLTVDKS 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 EEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFLLYSKLTVDKS 420
Qy 421 RWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK 452
||||||||||||||||||||||||||||||||
Db 421 RWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK 452
SEQ ID NO: 20 is 100% identical to SEQ ID NO: 23 (Adams):
WO2021228783-A1.
XX
CC PD 18-NOV-2021.
XX
CC PF 10-MAY-2021; 2021WO-EP062364.
XX
PR 11-MAY-2020; 2020US-0023092P.
PR 13-MAY-2020; 2020US-0024209P.
PR 10-MAR-2021; 2021US-0159303P.
XX
CC PA (JANC ) JANSSEN PHARM NV.
XX
CC PI Adams H, Goldberg J, Banerjee A, Stephenson T, Verona R;
CC PI Girgis S, Lin SXW;
XX
DR WPI; 2021-D0730K/097.
XX
CC PT Treating cancer i.e. multiple myeloma in subject, comprises administering
CC PT BCMA and CD3 bispecific antibody or antigen binding fragment to subject,
CC PT where subject is relapsed to treatment with prior anti-cancer treatment.
XX
CC PS Claim 5; SEQ ID NO 23; 119pp; English.
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 1130 100.0 215 BCM99790 -- 48 Anti-CD123xCD3 bispecific antibody light chain 1, SEQ ID 211.
ALIGNMENT:
Query Match 100.0%; Score 1130; Length 215;
Best Local Similarity 100.0%;
Matches 215; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QTVVTQEPSLTVSPGGTVTLTCRSSTGAVTTSNYANWVQQKPGQAPRGLIGGTNKRAPGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QTVVTQEPSLTVSPGGTVTLTCRSSTGAVTTSNYANWVQQKPGQAPRGLIGGTNKRAPGT 60
Qy 61 PARFSGSLLGGKAALTLSGVQPEDEAEYYCALWYSNLWVFGGGTKLTVLGQPKAAPSVTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PARFSGSLLGGKAALTLSGVQPEDEAEYYCALWYSNLWVFGGGTKLTVLGQPKAAPSVTL 120
Qy 121 FPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 FPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSY 180
Qy 181 LSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS 215
|||||||||||||||||||||||||||||||||||
Db 181 LSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS 215
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
6. Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (WO 2021/228783 A1, effectively filed 5/11/2020) in view of Kanapuram (US 2017/0209571 A1, pub. 7/27/2017).
Adams teaches the claim limitations of claim 2 as discussed above.
Adams does not disclose the stable aqueous pharmaceutical composition is stable at a temperature of about 2-8oC for at least 2 years.
Kanapuram teaches pharmaceutical compositions of bispecific antibodies, where one of the antigen binding domains is CD3. Kanapuram teaches that a typical liquid pharmaceutical formulations should have a shelf-life of 18 to 24 months. (See Kanapuram, pg. 13 [0161]). Kanapuram teaches that temperature can effect stability, with higher temperatures accelerating chemical reactions including oxidation and deamidation of proteins and freezing can denature proteins and cause protein aggregation. (See Kanapuram, pg. 3 [0042]-[0043]). Kanapuram also teaches that buffers such as acetate are useful for maintain an ideal pH of 4-7.5, and useful excipients for formulations include sucrose, polysorbate-20, and chelators including EDTA. (See Kanapuram, pgs. 1-2 [0010]-[[0012], also pg. 12 [0132]).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to combine the pharmaceutical composition of Adams with the teachings of Kanapuram for the storage stability of the present pharmaceutical composition. It would have been obvious because Kanapuram teaches that an ideal liquid formulation will have a shelf-life of 18-24 months and teaches the same chemical elements of an acetate buffer maintaining the pH between 4-7.5, and the added excipients of sucrose, polysorbate-20, and EDTA as being useful for making a stable aqueous formulation for a bispecific antibody, and a storage temperature of 2-8oC would be protective from increased temperature chemical reactions that could occur at room temperature and denaturing that can come from freezing temperatures. It would have a reasonable expectation of success because Kanapuram is applying these teachings to a bispecific antibody pharmaceutical composition that expresses CD3, similar to the bispecific antibody of Adams. Therefore, it would have been obvious to a person of ordinary skill in the art to apply the teachings of stability from Kanapuram to the pharmaceutical composition of Adams with a reasonable expectation of success at producing a stable aqueous bispecific antibody pharmaceutical composition of the present claimed invention.
7. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (WO 2021/228783 A1, effectively filed 5/11/2020) in view of Bandekar (US 2020/0308296 A1, pub. 10/1/2020).
Adams discloses the limitations of claim 2 as discussed above.
Adams does not disclose stability being defined based on color of solution, pH, turbidity, percentage of purity, percentage of new peaks, percentage of main component, percentage of high molecular weight species (HWMS), percentage of low molecular weight species (LMWS), percentage of sum of acidic peaks, percentage of sum of basic peaks, protein concentration, percentage of T cell activation, percentage of PS-20 (w/v), or any combination thereof.
Bandekar teaches clinical subcutaneous pharmaceutical compositions that include monoclonal antibodies. Bandekar teaches various methods of determining the antibody pharmaceutical composition is stable including evaluation of subvisible particles of the formulation by methods including micro flow imaging, size exclusion chromatography, capillary iso-electric focusing, SDS-PAGE, turbidity, osmolality, and pH. (See Bandekar, pg. 21 [0490]-[0491]).
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date to combine the bispecific antibody pharmaceutical composition of Adams with the teachings of Bandekar to determine stability according to the present claimed invention. It would have been obvious because it is known in the art that determining stability of a pharmaceutical composition is important to the compositions effectiveness and the methods of determining and defining stability are well known in the art and Bandekar teaches these methods as relative for a monoclonal antibody pharmaceutical composition. Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to combine the pharmaceutical composition of Adams with the teachings of Bandekar with a reasonable expectation of success at determining stability of the present claimed invention.
Conclusion
8. Claims 1-8, 10-14, 16-21, 23, 24, and 26-31 are rejected.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY DUNN whose telephone number is (571)272-5825. The examiner can normally be reached Monday-Friday 8-4:30.
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/LINDSAY DUNN/Examiner, Art Unit 1644
/Laura B Goddard/Primary Examiner, Art Unit 1642
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