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 .
1. The Election filed December 19, 2025, in response to the Office Action of September 23, 2025, is acknowledged and has been entered. Applicants elected without traverse Group I and the species of immunoconjugate polatuzumab vedotin-piiq.
Claims 1, 3, 6, 10-12, 20-24, 26, 29-31, 33-35, 38, 70, 102, 122, 128, 129, 145, 146, 150, 151, 193, 231, 269, 320, 321, 325 are pending. Claims 145, 146, 150, 151, 193, 231, 269, 320, 321, 325 have been withdrawn from further consideration by the examiner under 35 CFR 1.142(b) as being drawn to non-elected inventions. Claims 1, 3, 6, 10-12, 20-24, 26, 29-31, 33, 34, 38, 70, 102, 122, 128, 129 are currently under prosecution as drawn to the elected species of immunoconjugate polatuzumab vedotin-piiq.
Note: The terms “polatuzumab vedotin” and “polatuzumab vedotin-piiq” refer to the same immunoconjugate. See “Alternative names” for polatuzumab vedotin-piiq in the Table on page 1469 of Deeks (Drugs, 2019, 79:1467-1475).
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)(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.
2. Claim(s) 1, 3, 6, 10-12, 20-24, 26, 29-31, 33-35, 38, 70, 102, 128, and 129 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 2017/0304438, Polson et al.
Polson teaches a method for treating relapsed/refractory (R/R) follicular lymphoma (FL) in a human comprising administering to the human an effective amount of:
(a) polatuzumab vedotin-piiq immunoconjugate;
(b) venetoclax (Bcl-2 inhibitor); and
(c) anti-CD20 antibody rituximab or obinituzumab (claims 1-30, 33, 35-41; [79-84]; [136-138]; [147-152]; [155-161]; [181]; Example 7 [456-463]);
wherein polatuzumab is an anti-CD79b antibody comprising heavy and light chain SEQ ID NOs:36 and 38, respectively ([21-22]; [166]; claims 24 and 26), that are 100% identical to instant SEQ ID NOs:36 and 38 and comprise instant CDR SEQ ID NOs:21-26 (see sequence alignments below);
wherein polatuzumab vedotin is administered intravenously (IV) to the individual at a dose of 1.8 mg/kg; the venetoclax is administered orally at a dose of 800 mg; and the obinutuzumab is administered IV at a dose of 1000 mg and on the following days of six 21-day induction cycles and in the order listed below:
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115
468
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270
412
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wherein the venetoclax and obinutuzumab are administered as a maintenance phase and administration of venetoclax precedes administration of obinutuzumab:
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241
412
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wherein maintenance therapy comprises:
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133
458
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and wherein inclusion criteria for treatment is:
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271
462
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149
464
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255
464
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Given Polson teaches administering the same claimed drugs to the same claimed patients and at the same claimed doses, routes, and regimens, the method of Polson would necessarily produce the same claimed results of: achieving complete response (CR) during or after administration of the combination; result in a complete response in at least about 55% to at least about 100% of humans during or after administration of the combination; result in an objective response in at least about 70% to at least about 100% of humans during or after administration of the combination; not result in peripheral neuropathy of Grade 3 or greater; not result in tumor lysis syndrome; result in Grade 3 or 4 adverse event in about 64%, about 59% or about 73% or less of the humans treated; result in a duration of CR at least about 1 month to about 3 months or more; result in a CR after the six 21-day cycles; result in a CR in at least 55% to about 100% of humans treated after the six 21-day cycles, wherein the CR lasts at least about 1 month to at least about 3 months or more; and achieves a CR during or after the induction phase (as recited in instant claims 1, 11, 12, 24, 26, 70, and 102).
Instant SEQ ID NO:36 aligned with Polson SEQ ID NO:36
US-15-440-917-36
Filing date in PALM: 2017-02-23
Sequence 36, US/15440917
Publication No. US20170304438A1
GENERAL INFORMATION
APPLICANT: GENENTECH, INC.
TITLE OF INVENTION: METHODS OF USING ANTI-CD79B IMMUNOCONJUGATES
FILE REFERENCE: P32333-US-4
CURRENT APPLICATION NUMBER: US/15/440,917
CURRENT FILING DATE: 2017-02-23
PRIOR APPLICATION NUMBER: 14/863,125
PRIOR FILING DATE: 2015-09-23
PRIOR APPLICATION NUMBER: 62/136,324
PRIOR FILING DATE: 2015-03-20
PRIOR APPLICATION NUMBER: 62/076,823
PRIOR FILING DATE: 2014-11-07
PRIOR APPLICATION NUMBER: 62/054,257
PRIOR FILING DATE: 2014-09-23
NUMBER OF SEQ ID NOS: 55
SEQ ID NO 36
LENGTH: 446
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Description of Artificial Sequence: Synthetic
polypeptide
ALIGNMENT:
Query Match 100.0%; Score 2385; Length 446;
Best Local Similarity 100.0%;
Matches 446; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGYTFSSYWIEWVRQAPGKGLEWIGEILPGGGDTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGYTFSSYWIEWVRQAPGKGLEWIGEILPGGGDTNY 60
Qy 61 NEIFKGRATFSADTSKNTAYLQMNSLRAEDTAVYYCTRRVPIRLDYWGQGTLVTVSSAST120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEIFKGRATFSADTSKNTAYLQMNSLRAEDTAVYYCTRRVPIRLDYWGQGTLVTVSSAST120
Qy 121 KGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLY180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLY180
Qy 181 SLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSV240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSV240
Qy 241 FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTY300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTY300
Qy 301 RVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTK360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 RVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTK360
Qy 361 NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG420
Qy 421 NVFSCSVMHEALHNHYTQKSLSLSPG 446
||||||||||||||||||||||||||
Db 421 NVFSCSVMHEALHNHYTQKSLSLSPG 446
Instant SEQ ID NO:38 aligned with Polson SEQ ID NO:38
US-15-440-917-38
Filing date in PALM: 2017-02-23
Sequence 38, US/15440917
Publication No. US20170304438A1
GENERAL INFORMATION
APPLICANT: GENENTECH, INC.
TITLE OF INVENTION: METHODS OF USING ANTI-CD79B IMMUNOCONJUGATES
FILE REFERENCE: P32333-US-4
CURRENT APPLICATION NUMBER: US/15/440,917
CURRENT FILING DATE: 2017-02-23
PRIOR APPLICATION NUMBER: 14/863,125
PRIOR FILING DATE: 2015-09-23
PRIOR APPLICATION NUMBER: 62/136,324
PRIOR FILING DATE: 2015-03-20
PRIOR APPLICATION NUMBER: 62/076,823
PRIOR FILING DATE: 2014-11-07
PRIOR APPLICATION NUMBER: 62/054,257
PRIOR FILING DATE: 2014-09-23
NUMBER OF SEQ ID NOS: 55
SEQ ID NO 38
LENGTH: 218
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Description of Artificial Sequence: Synthetic
polypeptide
ALIGNMENT:
Query Match 100.0%; Score 1131; Length 218;
Best Local Similarity 100.0%;
Matches 218; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQLTQSPSSLSASVGDRVTITCKASQSVDYEGDSFLNWYQQKPGKAPKLLIYAASNLES 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQLTQSPSSLSASVGDRVTITCKASQSVDYEGDSFLNWYQQKPGKAPKLLIYAASNLES 60
Qy 61 GVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQSNEDPLTFGQGTKVEIKRTVAAPSVF120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQSNEDPLTFGQGTKVEIKRTVAAPSVF120
Qy 121 IFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLS180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 IFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLS180
Qy 181 STLTLSKADYEKHKVYACEVTHQGLSSPCTKSFNRGEC 218
||||||||||||||||||||||||||||||||||||||
Db 181 STLTLSKADYEKHKVYACEVTHQGLSSPCTKSFNRGEC 218
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.
4. Claim(s) 1 and 122 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 2017/0304438, Polson et al; in view of Herrera et al (Blood, 2016, 128(22):4194) and Yazdy et al (2017. Blood and Lymphatic Cancer: Targets and Therapy, 7, 73–83).
Polson teaches a method for treating follicular lymphoma (FL) patients as set forth above.
Polson does not teach treating the patients with G-CSF if a Grade 3 or 4 adverse event of neutropenia occurs.
Herrera teaches treating R/R FL patients with combination therapy encompassing polatuzuamb vedotin administered at 1.8 mg/kg IV and either rituximab or obinutuzumab administered at 1000 mg, wherein the most common Grade 3/4 adverse events in ≥10% of FL patients were neutropenia and thrombocytopenia (Results).
Yazdy teaches treating follicular lymphoma patients with obinutuzumab or rituximab combination therapies and teaches (p. 79, col. 2): “Administration of granulocyte colony stimulating factor (G-CSF) should be considered in patients with symptomatic grade 3–4 neutropenia.”
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to administer G-CSF if a Grade 3 or 4 adverse event of neutropenia occurred in the method of Polson. One would have been motivated to, and
have a reasonable expectation of success to because Herrera teaches this adverse event occurs in FL patients treated with polatuzuamb vedotin and obinutuzumab; and Yazdy teaches G-CSF is a known treatment for Grade 3 or 4 adverse events of neutropenia in FL patients.
5. Claim(s) 1, 3, 6, 10-12, 20-24, 26, 29-31, 33-35, 38, 70, 102, 128, and 129 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 2017/0304438, Polson et al; in view of Herrera et al (Blood, 2016, 128(22):4194); and Zinzani et al (Blood, 2016, 128(22): 617).
Polson teaches a method for treating R/R follicular lymphoma (FL) patients as set forth above. Polson further teaches efficacy objectives include measuring complete response (CR), partial response (PR), and objective response (CR or PR) after treatment ([151]; [422]; [424]; [452-455]).
Although Polson anticipates the instantly claimed methods for the reasons stated above, Polson does not teach or demonstrate the subsequent results of: achieving complete response (CR) during or after administration of the combination; result in a complete response in at least about 55% to at least about 100% of humans during or after administration of the combination; result in an objective response in at least about 70% to at least about 100% of humans during or after administration of the combination; not result in tumor lysis syndrome; result in Grade 3 or 4 adverse event in about 64%, about 59% or about 73% or less of the humans treated; result in a duration of CR at least about 1 month to about 3 months or more; result in a CR after the six 21-day cycles; result in a CR in at least 55% to about 100% of humans treated after the six 21-day cycles, wherein the CR lasts at least about 1 month to at least about 3 months or more; and achieve a CR during or after the induction phase (as recited in instant claims 1, 11, 12, 24, 26, 70, and 102).
Herrera teaches treating R/R FL patients with combination therapy encompassing polatuzuamb vedotin administered at 1.8 mg/kg IV and either rituximab or obinutuzumab administered at 1000 mg. Response was assessed after only 3 cycles of treatment. Herrera teaches the treatment resulted in an objective response rate (= complete response (CR) + partial response (PR)) of 100% in R/R FL patients (Table 2; Results). The majority of patients who achieved a CR or PR remained in response (Results).
Zinzani teaches treating R/R FL patients by administering venetoclax combined with rituximab. Zinzani teaches objective response with treatment was 33% even in a highly refractory patient population, and 64% among non-refractory patients (Conclusion). Zinzani teaches only 54% to 78% of patients suffered Grade 3-4 adverse events (Table 2), and only 1-6% of patients suffered tumor lysis syndrome (Table 2, meaning most did not suffer tumor lysis syndrome).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed for the method of Polson to achieve complete response (CR) during or after administration of the combination; result in a complete response in at least about 55% to at least about 100% of humans during or after administration of the combination; result in an objective response in at least about 70% to at least about 100% of humans during or after administration of the combination; not result in tumor lysis syndrome; result in Grade 3 or 4 adverse event in about 64%, about 59% or about 73% or less of the humans treated; result in a duration of CR at least about 1 month to about 3 months or more; result in a CR after the six 21-day cycles; result in a CR in at least 55% to about 100% of humans treated after the six 21-day cycles, wherein the CR lasts at least about 1 month to at least about 3 months or more; and achieve a CR during or after the induction phase. One would have been motivated to, and have a reasonable expectation of success to because: (1) Polson provides motivation to achieve CR and PR as efficacy objectives; (2) Herrera teaches that treatment of R/R FL patients with a combination therapy comprising polatuzuamb vedotin and either rituximab or obinutuzumab successfully resulted in an objective response rate of 100% in R/R FL patients, wherein the majority of patients who achieved a CR or PR remained in response, providing reasonable expectation of success to achieve high CR and PR percentages and long lasting response for the method of Polson comprising polatuzuamb vedotin and rituximab or obinutuzumab combination therapies; and (3) Zinzani teaches that treatment of R/R and non-R/R FL patients with a combination therapy comprising venetoclax and rituximab successfully resulted in 33% and 64% objective response rate, respectively, as well as only 54% to 78% of patients suffering Grade 3-4 adverse events and only 1-6% of patients suffering tumor lysis syndrome, providing a reasonable expectation of success to achieve the response rates and minimal Grade 3-4 adverse events and tumor lysis syndrome for the method of Polson comprising venetoclax and rituximab or anti-CD20 antibody combination therapies.
6. Claim(s) 122 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent 2017/0304438, Polson et al; Herrera et al (Blood, 2016, 128(22):4194); and Zinzani et al (Blood, 2016, 128(22): 617); as applied to claims 1, 3, 6, 10-12, 20-24, 26, 29-31, 33-35, 38, 70, 102, 128, and 129 above, and further in view of Herrera et al (Blood, 2016, 128(22):4194); and Zinzani et al (Blood, 2016, 128(22): 617).
Polson, Herrera, and Zinzanzi (the combined references) teach a method for treating R/R follicular lymphoma (FL) patients and achieving the CR after treatment, as set forth above.
The combined references do not teach treating the patients with G-CSF if a Grade 3 or 4 adverse event of neutropenia occurs.
Herrera and Yazdy teach as set forth above.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to administer G-CSF if a Grade 3 or 4 adverse event of neutropenia occurred in the method of the combined references. One would have been motivated to, and have a reasonable expectation of success to because Herrera teaches this adverse event occurs in FL patients treated with polatuzuamb vedotin and obinutuzumab; and Yazdy teaches G-CSF is a known treatment for Grade 3 or 4 adverse events of neutropenia in FL patients.
7. Conclusion: No claim is allowed.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
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/Laura B Goddard/ Primary Examiner, Art Unit 1642