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Case number IPR2017-01229

Celltrion Inc. v. Genentech, Inc. > Documents

Date Field Doc. No.PartyDescription
Mar 31, 2017 1 Petitioner's Power of Attorney Download
Mar 31, 2017 2 inadvertent filing Download
Mar 31, 2017 3 Petition for Inter Partes Review of U.S. Patent No. 8,206,711 Download
Apr 21, 2017 4 Power of Attorney Download
Apr 21, 2017 5 Mandatory Notice Download
Apr 24, 2017 6 Notice of Accord Filing Date Download
Jul 14, 2017 7 Patent Owner's Updated Mandatory Notice Download
Jul 24, 2017 8 Patent Owner Preliminary Response Download
Jul 24, 2017 9 Patent Owner's Exhibit List Download
Oct 23, 2017 10 Denying Institution of Inter Partes Review 37 C.F.R. sec 42.108 Download
Nov 30, 2017 11 Petitioner's Request for Refund of Post-Institution Fee Download
Dec 5, 2017 12 Notice of Refund Download
Mar 31, 2017 1001 U.S. Patent No. 8,206,711 Download
Mar 31, 2017 1002 U.S. Provisional Application No. 60/107,658 Download
Mar 31, 2017 1003 File History for U.S. Patent No. 8,206,711 (Excerpts) Download
Mar 31, 2017 1004 Part 1 - File History for U.S. Patent No. 7,682,612 (Excerpts) Download
Mar 31, 2017 1004 Part 2 - File History for U.S. Patent No. 7,682,612 (Excerpts) Download
Mar 31, 2017 1004 Part 2 - File History for U.S. Patent No. 7,682,612 (Excerpts) Download
Mar 31, 2017 1005 Declaration of Michael Andreeff, M.D. Download
Mar 31, 2017 1006 Archived website for Leukemia Insights Newsletter, 3(2) (Last Updated July 2, 1998) ("MD Anderson Online Newsletter") Download
Mar 31, 2017 1007 Public Hearing Transcript, Biological Response Modifiers Advisory Committee, Center for Biological Evaluation and Research, Food and Drug Administration, nineteenth meeting (July 25, 1997) ("FDA Transcript") Download
Mar 31, 2017 1008 Batata, A. & Shen, B., Relationship between Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma: A Comparative Study of Membrane Phenotypes in 270 Cases, Cancer, 70(3):625-632 (1992) ("Batata") Download
Mar 31, 2017 1009 Maloney, D.G. et al., Phase I Clinical Trial Using Escalating Single-Dose Infusion of Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Patients with Recurrent B-Cell Lymphoma, Blood, 84(8):2457-2466 (Oct. 15, 1994) ("Maloney 1994") Download
Mar 31, 2017 1010 Byrd, J.C. et al., Old and New Therapies in Chronic Lymphocytic Leukemia: Now Is the Time for a Reassessment of Therapeutic Goals, Semin. Oncol., 25(1):65-74 (Feb. 1998) Download
Mar 31, 2017 1011 Czuczman, M.S. et al., Chemoimmunotherapy of Low-Grade Lymphoma with the anti-CD20 Antibody IDEC-C2B8 in Combination with CHOP Chemotherapy, Cancer Invest., 14(Supp. 1):59-61 (Abstract 53) (1996) ("Czuczman") Download
Mar 31, 2017 1012 Harris, N.L. et al., World Health Organization Classification of Neoplastic Diseases of the Hematopoietic and Lymphoid Tissues: Report of the Clinical Advisory Committee Meeting-Airlie House, Virginia, November 1997, J. Clin. Oncol., 17(12):3835-3849 Download
Mar 31, 2017 1013 Anderson, D.R. et al., Targeted anti-cancer therapy using rituximab, a chimaeric anti-CD20 antibody (IDEC-C2B8) in the treatment of non-Hodgkin's B-cell lymphoma, Biochemical Society Transactions, 25(2):705-708 (May 1997) Download
Mar 31, 2017 1014 Maloney, D.G. et al., IDEC-C2B8: Results of a Phase I Multiple-Dose Trial in Patients With Relapsed Non-Hodgkin's Lymphoma, J. Clin. Oncol., 15(10):3266-3274 (Oct. 1997) ("Maloney Oct. 1997") Download
Mar 31, 2017 1015 Maloney, D.G. et al., IDEC-C2B8 (Rituximab) Anti-CD20 Monoclonal Antibody Therapy in Patients With Relapsed Low-Grade Non-Hodgkin"s Lymphoma, Blood, 90(6):2188-2195 (Sept. 15, 1997) ("Maloney Sept. 1997") Download
Mar 31, 2017 1016 McLaughlin, P. et al., Rituximab Chimeric Anti-CD20 Monoclonal Antibody Therapy for Relapsed Indolent Lymphoma: Half of Patients Respond to a Four-Dose Treatment Program, J. Clin. Oncol., 16(8):2825-2833 (Aug. 1998) ("McLaughlin") Download
Mar 31, 2017 1017 Link, B.K. et al., Phase II Pilot Study of the Safety and Efficacy of Rituximab in Combination with CHOP Chemotherapy in Patients with Previously Untreated Intermediate- or High-Grade NHL, Program/Proceedings Am. Society Clinical Oncology, 17:3a Download
Mar 31, 2017 1018 The Non-Hodgkin's Lymphoma Pathologic Classification Project, National Cancer Institute Sponsored Study of Classifications of Non-Hodgkin 's Lymphomas: Summary and Description of a Working Formulation for Clinical Usage, Cancer, 49(10):2112-2135 Download
Mar 31, 2017 1019 Harris, N.L. et al., A Revised European-American Classification of Lymphoid Neoplasms: A Proposal From the International Lymphoma Study Group, Blood, 84(5):1361-1392 (Sept. 1, 1994) Download
Mar 31, 2017 1020 Hiddemann, W. et al., Lymphoma Classification -- The Gap Between Biology and Clinical Management Is Closing, Blood, 88(11):4085-4089 (Dec. 1. 1996) Download
Mar 31, 2017 1021 The Non-Hodgkin's Lymphoma Classification Project, A Clinical Evaluation of the International Lymphoma Study Group Classification of Non-Hodgkin's Lymphoma, Blood, 89(11):3909-3918 (June 1, 1997) Download
Mar 31, 2017 1022 Cheson, B.D. et al., National Cancer Institute-Sponsored Working Group Guidelines for Chronic Lymphocytic Leukemia: Revised Guidelines for Diagnosis and Treatment, Blood, 87(12):4990-4997 (June 15, 1996) Download
Mar 31, 2017 1023 Ford, S.M. & Donegan, S.E., Immunotherapeutic Approaches to Treatment of B-Cell Neoplasms: Focus on Unconjugated Antibodies, Highlights in Oncology Practice, 16(2):40-50 (1998) Download
Mar 31, 2017 1024 Hall, A.G. & Tilby, M. J., Mechanisms of Action of, and Modes of Resistance to, Alkylating Agents Used in the Treatment of Haematological Malignancies, Blood Reviews, 163-173 (1992) Download
Mar 31, 2017 1025 Begleiter, A. et al., Chlorambucil in Chronic Lymphocytic Leukemia: Mechanism of Action, Leuk. Lymphoma 23:187-201 (1996) Download
Mar 31, 2017 1026 Keating, M.J. et al., Long-Term Follow-Up of Patients With Chronic Lymphocytic Leukemia (CLL) Receiving Fludarabine Regimens as Initial Therapy, Blood, 92(4):1165-1171 (Aug. 15, 1998) Download
Mar 31, 2017 1027 Johnson, S. et al., Multicentre prospective randomised trial of fludarabine versus cyclophosphamide, doxorubicin, and prednisone (CAP) for treatment of advanced-stage chronic lymphocytic leukaemia, Lancet, 347:1432-1438 (May 5, 1996) Download
Mar 31, 2017 1028 O'Brien, S.M. et al., Results of the Fludarabine and Cyclophosphamide Combination Regimen in Chronic Lymphocytic Leukemia, J. Clin. Oncol., 19(5):1414-1420 (Mar. 1, 2001) Download
Mar 31, 2017 1029 Protocol Activations and Closures, The CALGAB, 7(1):2 (Spring 1998) Download
Mar 31, 2017 1031 Koehl, U. et al., Fludarabine and cyclophosphamide: Synergistic cytotoxicity associated with inhibition of interstrand cross-link removal, Proc. Am. Assn. Cancer Res., 38:2 (Abstract 10) (Mar. 1997) Download
Mar 31, 2017 1032 O'Brien, S. et al., Fludarabine (FAMP) and Cyclophosphamide (CTX) Therapy in Chronic Lymphocytic Leukemia (CLL), Blood, 88(10, Supp. 1):480 (Abstract 1910) (Nov. 15, 1996) Download
Mar 31, 2017 1034 Genentech Press Release, Mar. 3, 1995 Download
Mar 31, 2017 1035 Grillo-L¿¿pez, A.J., Rituximab: An Insider¿¿¿s Historical Perspective, Semin. Oncol., 27(6, Supp. 12):9-16 (Dec. 2000) Download
Mar 31, 2017 1036 Declaration of David P. Schenkein, M.D. Under 37 C.F.R. §1.132, in U.S. Patent Application No. 09/436,347, dated November 14, 2008 ("Schenkein Decl. I:) Download
Mar 31, 2017 1037 Declaration of David P. Schenkein, M.D. Under 37 C.F.R. §1.132, in U.S. Patent Application No. 09/436,347, dated May 5, 2009 ("Schenkein Decl. II) Download
Mar 31, 2017 1038 Jensen, M. et al., Rapid tumor lysis in a patient with B-cell chronic lymphocytic leukemia and lymphocytosis treated with an anti-CD20 monoclonal antibody (IDEC-C2B8, rituximab), Ann. Hematol., 77:89-91 (1998) Download
Mar 31, 2017 1039 U.S. Patent Application No. 09/372,202 Download
Mar 31, 2017 1040 Stashenko, P. et al., Characterization of a Human B Lymphocyte-Specific Antigen, J. Immunol., 125(4):1678-1685 (Oct. 1980) Download
Mar 31, 2017 1041 Anderson, K.C. et al., Expression of Human B Cell-Associated Antigens on Leukemias and Lymphomas: A Model of Human B Cell Differentiation, Blood, 63(6):1424-1433 (June 1984) ("Anderson 1984") Download
Mar 31, 2017 1042 Leget, G.A. et al., Use of rituximab, the new FDA-approved antibody, Curr. Opin. Oncol., 10(6):548-551 (1998) Download
Mar 31, 2017 1043 Foon, K.A., Laboratory and Clinical Applications of Monoclonal Antibodies for Leukemias and Non-Hodgkin's Lymphoma, Curr. Probl. Cancer 63-128 (March/April 1989) Download
Mar 31, 2017 1044 Foon, K.A. & Fisher, R.I., Chapter 111: Lymphomas, in Williams Hematology, Fifth Edition, 1076-1096 (Beutler, E. et al., eds., 1995) Download
Mar 31, 2017 1045 Almasri, N.M. et al., Reduced Expression of CD20 Antigen as a Characteristic Marker for Chronic Lymphocytic Leukemia, Am. J. Hematol., 40(4):259-263 (1992) Download
Mar 31, 2017 1046 Demidem, A. et al., Chimeric Anti-CD20 (IDEC-C2B8) Monoclonal Antibody Sensitizes a B Cell Lymphoma Cell Line to Cell Killing by Cytotoxic Drugs, Cancer Biother. Radiopharm., 12(3):177-186 (1997) Download
Mar 31, 2017 1047 Piro, L. et al., RITUXAN™ (rituximab, IDEC-C2B8): Interim analysis of a Phase II study of once weekly times 8 dosing in patients with relapsed low-grade or follicular non-Hodgkin's lymphoma, Blood, 90(10, Supp. 1):510a (Abstract 2272) (1997) Download
Mar 31, 2017 1049 Second Declaration of David Schenkein, in opposition to European Patent No. EP-B1 1 616 572, dated June 5, 2013 ("Schenkein EP Decl., D71") Download
Mar 31, 2017 1050 Declaration of Dr. Michael Wenger, M.D., in opposition to European Patent No. EP-B1 1 616 572, dated January 31, 2014 ("Wenger EP Decl., D91") Download
Mar 31, 2017 1051 Declaration of Dr. Steven Edward Coutré, M.D., in opposition to European Patent No. EP-B1 1 616 572, dated February 3, 2014 ("Coutre EP Decl., D92") Download
Mar 31, 2017 1052 WO 94/11026 Download
Mar 31, 2017 1053 U.S. Patent No. 6,455,043 ("the '043 patent") Download
Mar 31, 2017 1054 FDA FOIA Response Letter (August 26, 2016) Download
Mar 31, 2017 1055 Kipps, T.J., Chapter 106: Chronic lymphocytic leukemia and related diseases, in Williams Hematology, Fifth Edition, 1017-1039 (Beutler, E. et al., eds., 1995) Download
Mar 31, 2017 1056 Declaration of Christopher Butler, Internet Archive, dated December 20, 2016, authenticating Archived website for Leukemia Insights Newsletter, 3(2) (Last Updated July 2, 1998), Ex. 1006 Download
Mar 31, 2017 1057 Nguyen, D. et al., IDEC-C2B8 anti-CD20 phase II trial: results on bone marrow and peripheral blood tumor response in patients with low grade Non-Hodgkin's (NHL)lymphoma/lymphoproliferative disorders (LPD), Blood, 90(10, Supp. 1):511a (Abstract 2277) Download
Mar 31, 2017 1058 Czuczman et al., IDEC-C2B8 (Rituximab) Alone and in Combination with CHOP in the Treatment of Low-Grade B-Cell Lymphoma, Cancer Invest., 16 (Supp. 1):21-22 (Abstract 17) (1998) Download
Mar 31, 2017 1059 Williams et al., Chapter 2: Examination of the Blood in Williams Hematology, Fifth Edition, 8-15 (Beutler et al., eds., 1995) Download
Mar 31, 2017 1060 Seng et al., Indolent B-cell Non-Hodgkin's Lymphomas, Oncology, 1(12):1883-1897 (December 1997) Download
Mar 31, 2017 1061 Leukemia Insights Newsletter, 3(2) (Summer 1998) Download
Mar 31, 2017 1062 Protocol for Phase I/II Study of IDEC-C2B8 (Rituximab) for Relapsed CLL (DM97-236) (December 10, 1997) Download
Mar 31, 2017 1064 Keating et al., Early Results of Chemoimmunotherapy Regimen of Fludarabine, Cyclophosphamide, and Rituximab as Initial Therapy for Chronic Lymphocytic Leukemia, J. Clin. Oncol., 23(18):4079-4088 (June 20, 2005) Download
Jul 24, 2017 2001 Ex. 2001 Chronic Lymphocytic Leukemia Download
Jul 24, 2017 2002 Ex. 2002 Proposals for the Classification of Chronic (Mature) B and T Lymphoid Leukaemias Download
Jul 24, 2017 2003 Ex. 2003 Chronic Lymphocytic Leukemia: Recommendations for Diagnosis, Staging, and Response Criteria Download
Jul 24, 2017 2004 Ex. 2004 Amendment and Reply to Office Action re US Patent Application 09/436,347 Download
Jul 24, 2017 2005 Ex. 2005 Request for Continued Examination (RCE) re US Patent Application 09/436,347 Download
Jul 24, 2017 2006 Ex. 2006 Fatal Acute Tumor Lysis Syndrome With Metastatic Breast Carcinoma Download
Jul 24, 2017 2007 Ex. 2007 Clinical Development Success Rates 2006-2015, June 2006 Download
Jul 24, 2017 2008 Ex. 2008 Definition of "Leukemia," NCI Dictionary of Cancer Terms Download
Jul 24, 2017 2009 Ex. 2009 Taber's Cyclopedic Medical Dictionary, Edition 18 Download
Jul 24, 2017 2010 Ex. 2010 Non-Institution Decision, Boehringer Ingelheim International GmbH v. Biogen Idec, Inc. Download
Jul 24, 2017 2011 Ex. 2011 Fludarabine and Acute Tumor Lysis In Chronic Lymphocytic Leukemia Download
Jul 24, 2017 2012 Ex. 2012 Declaration of Sharon Song Download
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