JP2021113206A5 - - Google Patents
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- JP2021113206A5 JP2021113206A5 JP2021068923A JP2021068923A JP2021113206A5 JP 2021113206 A5 JP2021113206 A5 JP 2021113206A5 JP 2021068923 A JP2021068923 A JP 2021068923A JP 2021068923 A JP2021068923 A JP 2021068923A JP 2021113206 A5 JP2021113206 A5 JP 2021113206A5
- Authority
- JP
- Japan
- Prior art keywords
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- lyophilized preparation
- diffraction pattern
- ray powder
- powder diffraction
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- 238000000634 powder X-ray diffraction Methods 0.000 claims 15
- 239000007787 solid Substances 0.000 claims 11
- 239000008194 pharmaceutical composition Substances 0.000 claims 10
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 8
- 229960004543 anhydrous citric acid Drugs 0.000 claims 4
- 239000004067 bulking agent Substances 0.000 claims 4
- 208000032839 leukemia Diseases 0.000 claims 4
- 206010028980 Neoplasm Diseases 0.000 claims 3
- 239000000872 buffer Substances 0.000 claims 3
- 201000011510 cancer Diseases 0.000 claims 3
- 208000031261 Acute myeloid leukaemia Diseases 0.000 claims 2
- 208000033776 Myeloid Acute Leukemia Diseases 0.000 claims 2
- 239000013543 active substance Substances 0.000 claims 2
- 239000007864 aqueous solution Substances 0.000 claims 2
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims 2
- 239000007979 citrate buffer Substances 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000000243 solution Substances 0.000 claims 2
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims 2
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims 2
- PWBHUSLMHZLGRN-UHFFFAOYSA-N 2-(4-chlorophenyl)-N-[[2-(2,6-dioxopiperidin-3-yl)-1-oxo-3H-isoindol-5-yl]methyl]-2,2-difluoroacetamide Chemical compound ClC1=CC=C(C=C1)C(C(=O)NCC=1C=C2CN(C(C2=CC=1)=O)C1C(NC(CC1)=O)=O)(F)F PWBHUSLMHZLGRN-UHFFFAOYSA-N 0.000 claims 1
- WENKGSGGXGQHSH-UHFFFAOYSA-N 3-(3-oxo-1h-isoindol-2-yl)piperidine-2,6-dione Chemical compound C1C2=CC=CC=C2C(=O)N1C1CCC(=O)NC1=O WENKGSGGXGQHSH-UHFFFAOYSA-N 0.000 claims 1
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 1
- 208000014697 Acute lymphocytic leukaemia Diseases 0.000 claims 1
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims 1
- 208000032791 BCR-ABL1 positive chronic myelogenous leukemia Diseases 0.000 claims 1
- 208000010833 Chronic myeloid leukaemia Diseases 0.000 claims 1
- 229920000858 Cyclodextrin Polymers 0.000 claims 1
- 108090000695 Cytokines Proteins 0.000 claims 1
- 102000004127 Cytokines Human genes 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 239000001116 FEMA 4028 Substances 0.000 claims 1
- 108010002386 Interleukin-3 Proteins 0.000 claims 1
- 102100039064 Interleukin-3 Human genes 0.000 claims 1
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 208000033761 Myelogenous Chronic BCR-ABL Positive Leukemia Diseases 0.000 claims 1
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 1
- 239000000427 antigen Substances 0.000 claims 1
- 102000036639 antigens Human genes 0.000 claims 1
- 108091007433 antigens Proteins 0.000 claims 1
- 239000002246 antineoplastic agent Substances 0.000 claims 1
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims 1
- 229960004853 betadex Drugs 0.000 claims 1
- 230000003115 biocidal effect Effects 0.000 claims 1
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims 1
- 239000003246 corticosteroid Substances 0.000 claims 1
- 229940111134 coxibs Drugs 0.000 claims 1
- 239000003255 cyclooxygenase 2 inhibitor Substances 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 239000002955 immunomodulating agent Substances 0.000 claims 1
- 229940121354 immunomodulator Drugs 0.000 claims 1
- 230000002584 immunomodulator Effects 0.000 claims 1
- 229960003444 immunosuppressant agent Drugs 0.000 claims 1
- 230000001861 immunosuppressant effect Effects 0.000 claims 1
- 239000003018 immunosuppressive agent Substances 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 229960001855 mannitol Drugs 0.000 claims 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 125000003854 p-chlorophenyl group Chemical group [H]C1=C([H])C(*)=C([H])C([H])=C1Cl 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 230000000306 recurrent effect Effects 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 1
- 229940097346 sulfobutylether-beta-cyclodextrin Drugs 0.000 claims 1
- 230000003319 supportive effect Effects 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
- 238000011282 treatment Methods 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662276756P | 2016-01-08 | 2016-01-08 | |
| US62/276,756 | 2016-01-08 | ||
| JP2018535283A JP6871256B2 (ja) | 2016-01-08 | 2017-01-06 | ２−（４−クロロフェニル）−ｎ−（（２−（２，６−ジオキソピペリジン−３−イル）−１−オキソイソインドリン−５−イル）メチル）−２，２−ジフルオロアセトアミドの製剤 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018535283A Division JP6871256B2 (ja) | 2016-01-08 | 2017-01-06 | ２−（４−クロロフェニル）−ｎ−（（２−（２，６−ジオキソピペリジン−３−イル）−１−オキソイソインドリン−５−イル）メチル）−２，２−ジフルオロアセトアミドの製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2021113206A JP2021113206A (ja) | 2021-08-05 |
| JP2021113206A5 true JP2021113206A5 (https=) | 2021-09-24 |
| JP7201732B2 JP7201732B2 (ja) | 2023-01-10 |
Family
ID=59273934
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018535283A Active JP6871256B2 (ja) | 2016-01-08 | 2017-01-06 | ２−（４−クロロフェニル）−ｎ−（（２−（２，６−ジオキソピペリジン−３−イル）−１−オキソイソインドリン−５−イル）メチル）−２，２−ジフルオロアセトアミドの製剤 |
| JP2021068923A Active JP7201732B2 (ja) | 2016-01-08 | 2021-04-15 | ２－（４－クロロフェニル）－ｎ－（（２－（２，６－ジオキソピペリジン－３－イル）－１－オキソイソインドリン－５－イル）メチル）－２，２－ジフルオロアセトアミドの製剤 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018535283A Active JP6871256B2 (ja) | 2016-01-08 | 2017-01-06 | ２−（４−クロロフェニル）−ｎ−（（２−（２，６−ジオキソピペリジン−３−イル）−１−オキソイソインドリン−５−イル）メチル）−２，２−ジフルオロアセトアミドの製剤 |
Country Status (19)
| Country | Link |
|---|---|
| US (4) | US10052315B2 (https=) |
| EP (2) | EP3399979B9 (https=) |
| JP (2) | JP6871256B2 (https=) |
| KR (1) | KR20180100565A (https=) |
| CN (2) | CN108601777B (https=) |
| AU (2) | AU2017205167B2 (https=) |
| BR (1) | BR112018013884A2 (https=) |
| CA (1) | CA3010797C (https=) |
| CL (1) | CL2018001830A1 (https=) |
| CO (1) | CO2018008305A2 (https=) |
| EA (1) | EA037508B1 (https=) |
| EC (1) | ECSP18051143A (https=) |
| ES (1) | ES2956767T3 (https=) |
| IL (1) | IL260403B (https=) |
| MX (1) | MX382150B (https=) |
| SA (1) | SA518391983B1 (https=) |
| SG (2) | SG11201805777QA (https=) |
| WO (1) | WO2017120437A1 (https=) |
| ZA (1) | ZA201804482B (https=) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9499514B2 (en) | 2014-07-11 | 2016-11-22 | Celgene Corporation | Antiproliferative compounds and methods of use thereof |
| CN108601777B (zh) | 2016-01-08 | 2021-08-03 | 细胞基因公司 | 2-(4-氯苯基)-n-((2-(2,6-二氧代哌啶-3-基)-1-氧代异吲哚啉-5-基)甲基)-2,2-二氟乙酰胺的制剂 |
| KR20180095094A (ko) * | 2016-01-08 | 2018-08-24 | 셀진 코포레이션 | 암을 치료하기 위한 방법 및 치료요법에 대한 임상 감수성의 예측변수로서 바이오마커의 용도 |
| US10245258B2 (en) | 2016-06-06 | 2019-04-02 | Celgene Corporation | Treatment of a hematologic malignancy with 2-(4-chlorophenyl)-N-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide |
| KR20200020899A (ko) * | 2017-06-30 | 2020-02-26 | 셀진 코포레이션 | 2-(4-클로로페닐)-n-((2-(2,6-디옥소피페리딘-3-일)-1-옥소이소인돌린-5-일)메틸)-2,2-디플루오로아세트아미드의 조성물 및 사용 방법 |
| CN113347974A (zh) * | 2018-12-31 | 2021-09-03 | 细胞基因公司 | 2-(4-氯苯基)-n-((2-(2,6-二氧代哌啶-3-基)-1-氧代异吲哚啉-5-基)甲基)-2,2-二氟乙酰胺的组合物和使用方法 |
| JP2022554346A (ja) | 2019-11-05 | 2022-12-28 | セルジーン コーポレーション | ２－（４－クロロフェニル）－ｎ－（（２－（２，６－ジオキソピペリジン－３－イル）－１－オキソイソインドリン－５－イル）メチル）－２，２－ジフルオロアセトアミドとの併用療法 |
| MX2022006133A (es) | 2019-12-06 | 2022-06-17 | Celgene Corp | Procesos para preparar 2-(4-clorofenil)-n-((2-(2,6-dioxopiperidin- 3-il)-1-oxoisoindolin-5-il)metil)-2,2-difluoroacetamida. |
| AU2022207648A1 (en) | 2021-01-13 | 2023-07-27 | Monte Rosa Therapeutics Ag | Isoindolinone compounds |
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| US5391485A (en) | 1985-08-06 | 1995-02-21 | Immunex Corporation | DNAs encoding analog GM-CSF molecules displaying resistance to proteases which cleave at adjacent dibasic residues |
| JPS63500636A (ja) | 1985-08-23 | 1988-03-10 | 麒麟麦酒株式会社 | 多分化能性顆粒球コロニー刺激因子をコードするｄｎａ |
| US4810643A (en) | 1985-08-23 | 1989-03-07 | Kirin- Amgen Inc. | Production of pluripotent granulocyte colony-stimulating factor |
| US6352694B1 (en) | 1994-06-03 | 2002-03-05 | Genetics Institute, Inc. | Methods for inducing a population of T cells to proliferate using agents which recognize TCR/CD3 and ligands which stimulate an accessory molecule on the surface of the T cells |
| US6534055B1 (en) | 1988-11-23 | 2003-03-18 | Genetics Institute, Inc. | Methods for selectively stimulating proliferation of T cells |
| US5360352A (en) | 1992-12-24 | 1994-11-01 | The Whitaker Corporation | Wire retainer for current mode coupler |
| US6692964B1 (en) | 1995-05-04 | 2004-02-17 | The United States Of America As Represented By The Secretary Of The Navy | Methods for transfecting T cells |
| US5855887A (en) | 1995-07-25 | 1999-01-05 | The Regents Of The University Of California | Blockade of lymphocyte down-regulation associated with CTLA-4 signaling |
| US6051227A (en) | 1995-07-25 | 2000-04-18 | The Regents Of The University Of California, Office Of Technology Transfer | Blockade of T lymphocyte down-regulation associated with CTLA-4 signaling |
| US5811097A (en) | 1995-07-25 | 1998-09-22 | The Regents Of The University Of California | Blockade of T lymphocyte down-regulation associated with CTLA-4 signaling |
| US5948893A (en) | 1996-01-17 | 1999-09-07 | The United States Of America As Represented By The Secretary Of The Navy | Murine hybridoma and antibody binding to CD28 receptor secreted by the hybridoma and method of using the antibody |
| US6207157B1 (en) | 1996-04-23 | 2001-03-27 | The United States Of America As Represented By The Department Of Health And Human Services | Conjugate vaccine for nontypeable Haemophilus influenzae |
| US6682736B1 (en) | 1998-12-23 | 2004-01-27 | Abgenix, Inc. | Human monoclonal antibodies to CTLA-4 |
| EP1212422B1 (en) | 1999-08-24 | 2007-02-21 | Medarex, Inc. | Human ctla-4 antibodies and their uses |
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| CA2466279A1 (en) | 2001-11-13 | 2003-05-22 | Dana-Farber Cancer Institute, Inc. | Agents that modulate immune cell activation and methods of use thereof |
| US7498171B2 (en) | 2002-04-12 | 2009-03-03 | Anthrogenesis Corporation | Modulation of stem and progenitor cell differentiation, assays, and uses thereof |
| CN101899114A (zh) | 2002-12-23 | 2010-12-01 | 惠氏公司 | 抗pd-1抗体及其用途 |
| DK2439273T3 (da) | 2005-05-09 | 2019-06-03 | Ono Pharmaceutical Co | Humane monoklonale antistoffer til programmeret død-1(pd-1) og fremgangsmåder til behandling af cancer ved anvendelse af anti-pd-1- antistoffer alene eller i kombination med andre immunterapeutika |
| PT1907424E (pt) | 2005-07-01 | 2015-10-09 | Squibb & Sons Llc | Anticorpos monoclonais humanos para o ligando 1 de morte programada (pd-l1) |
| US8877780B2 (en) | 2006-08-30 | 2014-11-04 | Celgene Corporation | 5-substituted isoindoline compounds |
| CN100457098C (zh) * | 2006-12-20 | 2009-02-04 | 南京科源医药技术有限公司 | 甲磺酸萘莫司他冻干粉针剂及其制备方法 |
| BR122017025062B8 (pt) | 2007-06-18 | 2021-07-27 | Merck Sharp & Dohme | anticorpo monoclonal ou fragmento de anticorpo para o receptor de morte programada humano pd-1, polinucleotídeo e composição compreendendo o referido anticorpo ou fragmento |
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| PT2358697E (pt) * | 2008-10-29 | 2016-02-03 | Celgene Corp | Compostos de isoindolina para utilização no tratamento do cancro |
| EP3255060A1 (en) | 2008-12-09 | 2017-12-13 | F. Hoffmann-La Roche AG | Anti-pd-l1 antibodies and their use to enhance t-cell function |
| JP5844159B2 (ja) | 2009-02-09 | 2016-01-13 | ユニヴェルシテ デクス−マルセイユＵｎｉｖｅｒｓｉｔｅ Ｄ’Ａｉｘ−Ｍａｒｓｅｉｌｌｅ | Ｐｄ−１抗体およびｐｄ−ｌ１抗体ならびにその使用 |
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| WO2011082400A2 (en) | 2010-01-04 | 2011-07-07 | President And Fellows Of Harvard College | Modulators of immunoinhibitory receptor pd-1, and methods of use thereof |
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| US8974811B2 (en) * | 2013-03-14 | 2015-03-10 | Hikma Pharmaceuticals | Stabilized pharmaceutical formulations comprising antineoplastic compounds |
| EP2991651A1 (en) | 2013-05-03 | 2016-03-09 | Celgene Corporation | Methods for treating cancer using combination therapy |
| US9499514B2 (en) | 2014-07-11 | 2016-11-22 | Celgene Corporation | Antiproliferative compounds and methods of use thereof |
| WO2017120415A1 (en) | 2016-01-08 | 2017-07-13 | Celgene Corporation | Solid forms of 2-(4-chlorophenyl)-n-((2-2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl) methyl)-2,2-difluoroacetamide, and their pharmaceutical compositions and uses |
| SG11201805779TA (en) | 2016-01-08 | 2018-08-30 | Celgene Corp | Antiproliferative compounds, and their pharmaceutical compositions and uses |
| CN108601777B (zh) * | 2016-01-08 | 2021-08-03 | 细胞基因公司 | 2-(4-氯苯基)-n-((2-(2,6-二氧代哌啶-3-基)-1-氧代异吲哚啉-5-基)甲基)-2,2-二氟乙酰胺的制剂 |
| JP2019011495A (ja) | 2017-06-30 | 2019-01-24 | 株式会社Ｕａｃｊ押出加工 | 熱交換器に配管部材を接続するためのアルミニウム合金製コネクタ及び該コネクタを備える熱交換器接続用配管部材、並びにこれらの製造方法 |
| CN113347974A (zh) | 2018-12-31 | 2021-09-03 | 细胞基因公司 | 2-(4-氯苯基)-n-((2-(2,6-二氧代哌啶-3-基)-1-氧代异吲哚啉-5-基)甲基)-2,2-二氟乙酰胺的组合物和使用方法 |
| JP2022554346A (ja) | 2019-11-05 | 2022-12-28 | セルジーン コーポレーション | ２－（４－クロロフェニル）－ｎ－（（２－（２，６－ジオキソピペリジン－３－イル）－１－オキソイソインドリン－５－イル）メチル）－２，２－ジフルオロアセトアミドとの併用療法 |
-
2017
- 2017-01-06 CN CN201780005873.3A patent/CN108601777B/zh active Active
- 2017-01-06 CN CN202110818391.8A patent/CN113633634A/zh active Pending
- 2017-01-06 BR BR112018013884A patent/BR112018013884A2/pt not_active Application Discontinuation
- 2017-01-06 SG SG11201805777QA patent/SG11201805777QA/en unknown
- 2017-01-06 EA EA201891578A patent/EA037508B1/ru unknown
- 2017-01-06 KR KR1020187019190A patent/KR20180100565A/ko not_active Ceased
- 2017-01-06 SG SG10202007913WA patent/SG10202007913WA/en unknown
- 2017-01-06 JP JP2018535283A patent/JP6871256B2/ja active Active
- 2017-01-06 ES ES17736406T patent/ES2956767T3/es active Active
- 2017-01-06 EP EP17736406.4A patent/EP3399979B9/en active Active
- 2017-01-06 EP EP23181094.6A patent/EP4275707A3/en not_active Withdrawn
- 2017-01-06 US US15/400,791 patent/US10052315B2/en active Active
- 2017-01-06 WO PCT/US2017/012483 patent/WO2017120437A1/en not_active Ceased
- 2017-01-06 CA CA3010797A patent/CA3010797C/en active Active
- 2017-01-06 MX MX2018008429A patent/MX382150B/es unknown
- 2017-01-06 AU AU2017205167A patent/AU2017205167B2/en active Active
-
2018
- 2018-07-03 IL IL260403A patent/IL260403B/en unknown
- 2018-07-04 CL CL2018001830A patent/CL2018001830A1/es unknown
- 2018-07-04 ZA ZA201804482A patent/ZA201804482B/en unknown
- 2018-07-05 SA SA518391983A patent/SA518391983B1/ar unknown
- 2018-07-06 EC ECSENADI201851143A patent/ECSP18051143A/es unknown
- 2018-07-19 US US16/040,450 patent/US10449187B2/en active Active
- 2018-08-08 CO CONC2018/0008305A patent/CO2018008305A2/es unknown
-
2019
- 2019-09-09 US US16/565,346 patent/US11129821B2/en active Active
-
2021
- 2021-04-15 JP JP2021068923A patent/JP7201732B2/ja active Active
- 2021-08-25 US US17/412,187 patent/US11883389B2/en active Active
- 2021-09-29 AU AU2021240184A patent/AU2021240184A1/en not_active Abandoned
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