IP Verse

Charged Depth Filtration Of Antigen-Binding Proteins - EP3334747

The patent EP3334747 was granted to Amgen on Sep 27, 2023. The application was originally filed on Aug 12, 2016 under application number EP16757780A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3334747

AMGEN
Application Number
EP16757780A
Filing Date
Aug 12, 2016
Status
Granted And Under Opposition
Aug 25, 2023
Grant Date
Sep 27, 2023
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (8)

Patent oppositions filed by competitors challenge the validity of a granted patent. These oppositions are typically based on claims of prior art, lack of novelty, or non-obviousness. They are a key part of the process for determining a patent's strength and enforceability.

CompanyOpposition DateRepresentativeOpposition Status

Get instant alerts for new oppositions and patent status changes

GRAF VON STOSCH PATENTANWALTSGESELLSCHAFTJun 27, 2024LEPTHIENADMISSIBLE
HAMPTON KNOWLESJun 27, 2024D YOUNGADMISSIBLE
HEMSATHJun 27, 2024KONIG SZYNKA TILMANN VON RENESSE PATENTANWALTE PARTNERSCHAFT MBB DUSSELDORFADMISSIBLE
MAIWALDJun 27, 2024MAIWALDADMISSIBLE
MARGARET DIXONJun 27, 2024MEWBURN ELLISADMISSIBLE
WITHERS & ROGERSJun 26, 2024TOMBLINGADMISSIBLE
MARGARET DIXONJun 7, 2024MEWBURN ELLISADMISSIBLE
ROTHSep 28, 2023KONIG SZYNKA TILMANN VON RENESSE PATENTANWALTE PARTNERSCHAFT MBB DUSSELDORFADMISSIBLE

Patent Citations (30) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2009053786
DESCRIPTIONUS2014024111
DESCRIPTIONUS6284471
DESCRIPTIONUS8529902
INTERNATIONAL-SEARCH-REPORTUS2010056759
INTERNATIONAL-SEARCH-REPORTUS2013273607
INTERNATIONAL-SEARCH-REPORTUS2014010820
INTERNATIONAL-SEARCH-REPORTUS2015133636
INTERNATIONAL-SEARCH-REPORTWO2014100443
INTERNATIONAL-SEARCH-REPORTWO2015070068
OPPOSITIONUS11098079
OPPOSITIONUS2010056759
OPPOSITIONUS2011207196
OPPOSITIONUS2012157664
OPPOSITIONUS2012264920
OPPOSITIONUS2014010820
OPPOSITIONUS2015133636
OPPOSITIONWO03066669
OPPOSITIONWO2008036899
OPPOSITIONWO2009009523
OPPOSITIONWO2010017964
OPPOSITIONWO2010125187
OPPOSITIONWO2011146179
OPPOSITIONWO2012051147
OPPOSITIONWO2012054679
OPPOSITIONWO2014100443
OPPOSITIONWO2014145744
OPPOSITIONWO2015070068
OPPOSITIONWO2016106291
OPPOSITIONWO2017027861

Non-Patent Literature (NPL) Citations (48) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
OPPOSITION- 3m, "Zeta Plus®BioCap™ - Disposable Filter Capsules for the Biotechnology & Pharmaceutical Industries", CUNO Product Brochure, (20070101), pages 1 - 8, XP093195632-
OPPOSITION- 3m, "Zeta Plus® CP & SP Series", Data Sheet, (20070101), pages 1 - 5, XP093195629-
OPPOSITION- 3m, "Zeta Plus ZA Series - Depth Filter Cartridges & Capsules", Product Data Sheet, (20090201), pages 1 - 4, XP093195626-
OPPOSITION- Anonymous, "Diatomaceous earth", Wikipedia, (20240809), Wikipedia, URL: https://en.wikipedia.org/w/index.php?title=Diatomaceous_earth&oldid=1227216614%27, XP093195634-
OPPOSITION- Anonymous, "Millistak+® Pod depth filter system", Merck KGaA - Data Sheet, (20130101), pages 1 - 8, Merck KGaA - Data Sheet, URL: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/151/827/millistak-datasheet-ds0217en-mk.pdf, XP093195094-
OPPOSITION- Anonymous, "Zeta Plus® BioCap™ Disposable Filter Capsules", Product Data Sheet, (19970101), pages FP, 1 - 7, XP093195612-
OPPOSITION- Capozzi G., Modena G., "Chapter 17 - Oxidation of thiols", The Chemistry of the Thiol Group, (19740101), pages 785 - 839, XP093195623-
OPPOSITION- Emdmillipore, "Millistak+® Pod Disposable Depth Filter ", Performance Guide, (20130601), pages 1 - 28, XP093195614-
OPPOSITION- Emea, "Guideline On Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products", EMEA/CHMP/BWP/157653/2007, (20081218), pages 1 - 11, XP093195606-
OPPOSITION- Faber Rene, Yang Yujing, Gottschalk Uwe, "Salt Tolerant Interaction Chromatography for Large-Scale Polishing with Convective Media", BIOPHARM INTERNATIONAL, ADVANSTAR COMMUNICATIONS, DULUTH, MN, US, US , (20091002), vol. 2009suppl., no. 7, ISSN 1542-166X, XP093195615-
OPPOSITION- Gennaro Lynn, Felten Chantal, "Optimization Approaches in the Routine Analysis of Monoclonal Anitbodies by Capillary Electrophoresis", LCGC Europe, (20081201), LCGC Europe, URL: https://www.chromatographyonline.com/view/optimization-approaches-routine-analysis-monoclonal-anitbodies-capillary-electrophoresis-0, XP093195079-
OPPOSITION- Jornitz Maik W., Meltzer Theodore H., Filtration and Purification in the Biopharmaceutical Industry, 2nd ed., (20080101), page 540, XP093195625-
OPPOSITION- Kadey, Jr. Frederic L., "Diatomite", Industrial Minerals and Rocks, (19830101), pages 677 - 708, XP093195613-
OPPOSITION- Millipore, "Millistak+® Pod Disposable Depth Filter System", Data Sheet, (20090401), pages 1 - 4, XP093195627-
OPPOSITION- Millipore, "Millistak+® Pods", Validation Guide, (20150201), pages FP, 1 - 105, XP093195636-
OPPOSITION- Millipore Sigma, "Pod Depth Filters", User Guide, (20210501), pages 1 - 12, XP093195630-
OPPOSITION- O'brien Thomas P, Brown Laura A, Battersby Dennis G, Rudolph Aimee S, Raman L P, "Large-Scale, Single-Use Depth Filtration Systems for Mammalian Cell Culture Clarification", BioProcess International, (20120501), vol. 10, no. 5s, pages 50 - 57, XP093195594-
OPPOSITION- Schreffler John, Bailley Matthew, Klimek Tom, Agneta Peter, Wiltsie W Erick, Felo Michael, Maisey Pam, Zuo Xun, Routhier Eric, "Characterization of Postcapture Impurity Removal Across an Adsorptive Depth Filter", BioProcess TECHNICAL, (20150301), vol. 13, no. 3, pages 36 - 45, XP093195617-
OPPOSITION- Wang Tian, Liu Yaoqing Diana, Cai Bing, Huang Gang, Flynn Gregory C., "Investigation of antibody disulfide reduction and re-oxidation and impact to biological activities", Journal of Pharmaceutical and Biomedical Analysis, (20150101), vol. 102, pages 519 - 528, XP093195607-
OPPOSITION- Wehr Tim, Wehr Tim, "Capillary electrophoresis in the biopharmaceutical industry: Part I", LC GC NORTH AMERICA, ADVANSTAR COMMUNICATIONS, DULUTH, MN, US, US , (20050701), vol. 23, no. 7, ISSN 1527-5949, pages 676 - 681, XP093195074-
OPPOSITION- Wenz Christian, "Performance of commercially available gels for protein characterization by capillary gel electrophoresis with UV detection on the Agilent 7100 CE System", Agilent Technologies - Application Note, (20110701), Agilent Technologies - Application Note, URL: https://www.agilent.com/cs/library/applications/5990-7976EN.pdf, XP093195077-
OPPOSITION- Yavorsky Dav, Robert Blanck, Charles Lambalot, Roger Brunkow, "The clarification of bioreactor cell cultures for biopharmaceuticals", Pharmaceutical Technolog, (20030301), pages 62 - 76, XP093195067-
OPPOSITION- Engh Kenneth R., "Diatomite", KIRK-OTHMER ENCYCLOPEDIA OF CHEMICAL TECHNOLOGY (4th edition), Hoboken, NJ, USA , Wiley-Interscience , (20140101), pages 1 - 11, doi:10.1002/0471238961.0409012005140708.a01.pub2, ISBN 978-0-471-48494-3, XP093195600
OPPOSITION- Trexler-Schmidt M, Sargis S, Chiu J, Sze-Khoo S, Mun M, Kao YH, Laird M W, "Identification and prevention of antibody disulfide bond reduction during cell culture manufacturing", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20100615), vol. 106, no. 3, doi:10.1002/BIT.22699, ISSN 0006-3592, pages 452 - 461, XP002694206
OPPOSITION- Kao Y H, Hewitt D P, Trexler-Schmidt M, Laird M W., "Mechanism of Antibody Reduction in Cell Culture Production Processes", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20101101), vol. 107, no. 4, doi:10.1002/bit.22848, ISSN 0006-3592, pages 622 - 632, XP002694207
OPPOSITION- Yung‐Hsiang Kao; Daniel P. Hewitt; Melody Trexler‐Schmidt; Michael W. Laird, "Mechanism of antibody reduction in cell culture production processes", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20100629), vol. 107, no. 4, doi:10.1002/bit.22848, ISSN 0006-3592, pages 622 - 632, XP071152739
OPPOSITION- Melissa Mun, Stefanie Khoo, Aline Do Minh, James Dvornicky, Melody Trexler-Schmidt, Yung-Hsiang Kao, Michael W. Laird, "Air sparging for prevention of antibody disulfide bond reduction in harvested CHO cell culture fluid : Air Sparging for Prevention of Antibody Reduction", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20150401), vol. 112, no. 4, doi:10.1002/bit.25495, ISSN 0006-3592, pages 734 - 742, XP055487175
OPPOSITION- Nripen Singh, Abhiram Arunkumar, Srinivas Chollangi, Zhijun George Tan, Michael Borys, Zheng Jian Li, "Clarification technologies for monoclonal antibody manufacturing processes: Current state and future perspectives", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20160401), vol. 113, no. 4, doi:10.1002/bit.25810, ISSN 0006-3592, pages 698 - 716, XP055315431
OPPOSITION- Wai Keen Chung; Brian Russell; Yanhong Yang; Michael Handlogten; Suzanne Hudak; Mingyan Cao; Jihong Wang; David Robbins; Sanjeev Ahuja; Min Zhu, "Effects of antibody disulfide bond reduction on purification process performance and final drug substance stability", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20170306), vol. 114, no. 6, doi:10.1002/bit.26265, ISSN 0006-3592, pages 1264 - 1274, XP071153334
OPPOSITION- Brian O'Mara; Zhong-Hua Gao; Manju Kuruganti; Robert Mallett; Gautam Nayar; Laura Smith; Jeffrey D. Meyer; Jon Therriault; Cameron Miller; John Cisney; John Fann, "Impact of depth filtration on disulfide bond reduction during downstream processing of monoclonal antibodies from CHO cell cultures", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20190404), vol. 116, no. 7, doi:10.1002/bit.26964, ISSN 0006-3592, pages 1669 - 1683, XP071108839
OPPOSITION- Richard R. Rustandi; Michael W. Washabaugh; Yang Wang, "Applications of CE SDS gel in development of biopharmaceutical antibody‐based products", Electrophoresis, Verlag Chemie, Hoboken, USA, Hoboken, USA, (20080919), vol. 29, no. 17, doi:10.1002/elps.200700958, ISSN 0173-0835, pages 3612 - 3620, XP071498944
OPPOSITION- Gramer Michael J., "Product Quality Considerations for Mammalian Cell Culture Process Development and Manufacturing", Mammalian Cell Cultures for Biologics Manufacturing, Berlin, Heidelberg, Springer Berlin Heidelberg, (20130101), vol. 139, pages 123 - 166, doi:10.1007/10_2013_214, ISSN 0724-6145, ISBN 978-3-642-54050-9, XP093039744
OPPOSITION- S. Mendioroz, M. J. Belzunce, J. A. Pajares, "Thermogravimetric study of diatomites", JOURNAL OF THERMAL ANALYSIS., HEYDEN AND SON, LONDON., GB, GB , (19891101), vol. 35, no. 7, doi:10.1007/BF01911874, ISSN 0368-4466, pages 2097 - 2104, XP055410300
OPPOSITION- Kristen L. Koterba; Trissa Borgschulte; Michael W. Laird;, "Thioredoxin 1 is responsible for antibody disulfide reduction in CHO cell culture", Journal of Biotechnology, Elsevier, Amsterdam NL, Amsterdam NL , (20111116), vol. 157, no. 1, doi:10.1016/j.jbiotec.2011.11.009, ISSN 0168-1656, pages 261 - 267, XP028395757
OPPOSITION- Shukla, A.A. Hubbard, B. Tressel, T. Guhan, S. Low, D., "Downstream processing of monoclonal antibodies-Application of platform approaches", Journal of Chromatography B, ELSEVIER, AMSTERDAM., NL, NL , (20070312), vol. 848, no. 1, doi:10.1016/j.jchromb.2006.09.026, ISSN 1570-0232, pages 28 - 39, XP005922825
OPPOSITION- MAGNUSSON C G , BJOERNSTEDT M, HOLMGREN A, "Human IgG is substrate for the thioredoxin system: differential cleavage pattern of interchain disulfide bridges in IgG subclasses.", Molecular Immunology, PERGAMON, GB, GB , (19970701), vol. 34, no. 10, doi:10.1016/S0161-5890(97)00092-8, ISSN 0161-5890, pages 709 - 717, XP002497450
OPPOSITION- Martinez et al., "Disulfide Connectivity of Human Immunoglobulin G2 Structural Isoforms", Biochemistry , (2008), vol. 47, doi:10.1021/BI800576C, XP002512403
OPPOSITION- CHADERJIAN WENDY B, ET AL, "Effect of copper sulfate on performance of a serum-free CHO cell culture process and the level of free thiol in the recombinant antibody expressed", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20050301), vol. 21, no. 2, doi:10.1021/BP0497029, ISSN 8756-7938, pages 550 - 553, XP002500111
OPPOSITION- Yinges Yigzaw; Robert Piper; Minh Tran; Abhinav A. Shukla, "Exploitation of the Adsorptive Properties of Depth Filters for Host Cell Protein Removal during Monoclonal Antibody Purification", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20080916), vol. 22, no. 1, doi:10.1021/bp050274w, ISSN 8756-7938, pages 288 - 296, XP072299095
OPPOSITION- D.J. Roush, Y. Lu, "Advances in Primary Recovery: Centrifugation and Membrane Technology", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20080606), vol. 24, no. 3, doi:10.1021/bp070414x, ISSN 8756-7938, pages 488 - 495, XP055090116
OPPOSITION- P. S. Rommer; A. Dudesek; O. Stuve; U.K. Zettl, "Monoclonal antibodies in treatment of multiple sclerosis", Clinical and experimental immunology, Wiley-Blackwell Publishing Ltd., GB, GB , (20140204), vol. 175, no. 3, doi:10.1111/cei.12197, ISSN 0009-9104, pages 373 - 384, XP071084519
OPPOSITION- C. Nattrass;C. J. Horwell;D. E. Damby;A. Kermanizadeh;D. M. Brown;V. Stone, "The global variability of diatomaceous earth toxicity: a physicochemical and in vitro investigation", Journal of Occupational Medicine and Toxicology, BioMed Central Ltd, Lo, Lo , (20150710), vol. 10, no. 1, doi:10.1186/s12995-015-0064-7, ISSN 1745-6673, page 23, XP021228690
OPPOSITION- Reka Arianit A., Pavlovski Blagoj, Fazlija Emira, Berisha Avni, Pacarizi Musaj, Daghmehchi Maria, Sacalis Carmen, Jovanovski Gligor, Makreski Petre, Oral Ayhan, "Diatomaceous Earth: Characterization, thermal modification, and application", OPEN CHEM., (20210101), vol. 19, no. 1, doi:10.1515/chem-2020-0049, ISSN 2391-5420, pages 451 - 461, XP093195604
OPPOSITION- Katariina M Hutterer, Robert W Hong, Jonathon Lull, Xiaoyang Zhao, Tian Wang, Rex Pei, M Eleanor Le, Oleg Borisov, Rob Piper, Yaoqing Diana Liu, Krista Petty, Izydor Apostol, Gregory C Flynn, "Monoclonal antibody disulfide reduction during manufacturing: Untangling process effects from product effects.", mAbs, Landes Bioscience, US, US , (20130101), vol. 5, no. 4, doi:10.4161/mabs.2475, ISSN 1942-0862, pages 608 - 613, XP055514733
OPPOSITION- Hui F. Liu, Ma Junfen, Winter Charles, Bayer Robert, "Recovery and purification process development for monoclonal antibody production", mAbs, (20100901), vol. 2, no. 5, doi:10.4161/mabs.2.5.12645, ISSN 19420862, pages 480 - 499, XP055027612
OPPOSITION- Liu H F, Ma J, Winter C, Bayer R., "Recovery and purification process development for monoclonal antibody production", mAbs, Landes Bioscience, US, US , (20100901), vol. 2, no. 5, doi:10.4161/mabs.2.5.12645 , ISSN 1942-0862, pages 480 - 499, XP002691388
OPPOSITION- Hongcheng Liu, Kimberly May, "Disulfide bond structures of IgG molecules: Structural variations, chemical modifications and possible impacts to stability and biological function", mAbs, (20120101), vol. 4, no. 1, doi:10.4161/mabs.4.1.18347, ISSN 19420862, pages 17 - 23, XP055134217
OPPOSITION- Catalin Doneanu, Alex Xenopoulos, Keith Fadgen, Jim Murphy, St. John Skilton, Holly Prentice, Martha Stapels, Weibin Chen, "Analysis of host-cell proteins in biotherapeutic proteins by comprehensive online two-dimensional liquid chromatography/mass spectrometry", mAbs, Landes Bioscience, US, US , (20120101), vol. 4, no. 1, doi:10.4161/mabs.4.1.18748, ISSN 1942-0862, pages 24 - 44, XP055297897

Download Citation Report

Get a free citation report including examiner, opposition, and international search citations.

Get Citation Report

Dossier Documents

The dossier documents provide a comprehensive record of the patent’s prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent’s legal journey and any challenges it may have faced during examination.

  • Date

    Description

  • Get instant alerts for new documents