Date Field | Doc. No. | Party | Description |
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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 |