Foundation Medicine, Inc. et al. vs Caris MPI, Inc. et al.

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ORDER Oral Hearing 37 C.F.R. ¿¿ 42.70

Table A1 Pairings of Targets and Drugs

Nicholson, Modulation of Epidermal Growth Factor Receptor in Endocrine Resistant, Oestrogen Receptor Positive Breast Cancer

Moulder, et al. Epidermal Growth Factor Receptor (HER1) Tyrosine Kinase Inhibitor ZD1839 (Iressa) Inhibits HER2/neu (erbB2) overexpressing Breast Cancer Cells in Vitro and In Vivo

Patent Owner's Sur-Reply

Transcript of the Deposition of Paul T. Spellman, Volume II, January 15, 2020

Patent Owner's Request for Oral Argument

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Patent Owner's Updated Mandatory Notices

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Ex. 3004

Order - Modifying the Scheduling Order - 37 CFR 42.5(c)

Patent Owner's Notice of Deposition of Paul T. Spellman, Ph.D

Mori et al., 17 Intl J. Oncology 33 (2000)

HUGO Gene Nomenclature Committee Symbol Report

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File History Excerpt for U.S. Patent Application No. 11/750,721

Chen, 9 The Oncologist 27 (2004)

Deposition Transcript of Joyce A. O'Shaughnessy, M.D., Volume 1 of 2

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Reply Declaration of Paul T. Spellman, Ph.D.

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U.S. Patent No. 8,700,335

Kouwaki et al. 4 Clinical Cancer Res. 2999 (1998)

Etienne et al., 12 J. Clinical Oncology 2248 (1994)

Clinical Trial Ref. No. NCT00066339

Clinical Trial Ref. No. NCT01051596

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U.S. Provisional Patent Application No. 60/747,645

U.S. Patent Application Publication No. 2008-0014146

Longley et al., 3 Nature Reviews Cancer 330 (2003)

Fluorouracil Injection Label

Clinical Trial Ref. No. NCT00006121

Clinical Trial Ref. No. NCT00065533

Clinical Trial Ref. No. NCT00113373

Clinical Trial Ref. No. NCT00305838

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Beumer et al., 156 Breast Cancer Res. Treatment 279 (2016)

Petitioner's Reply to Patent Owner's Response

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PANEL CHANGE ORDER Conduct of the Proceedings 37 C.F.R. ¿¿ 42.5

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Patent Owner's Unopposed Motion for Pro Hac Vice Admission of Corrin Drakulich

Patent Owner's Unopposed Motion for Pro Hac Vice Admission of Christina Brown-Marshall

Declaration of Christina Brown-Marshall

Petitioner's Notice of Deposition of Joyce A. O'Shaughnessy, M.D.

Expert Declaration of Joyce O'Shaughnessy MD

Sorlie etal Repeated Observation of Breast Tumor Subtypes in Independent Gene Expression Sets

Lynch et al Activating mutation in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib

National Comprehensive Cancer Network, Gastric Cancer Clinical Practice Guidelines in Oncology

Hanahan, et al The Hallmarks of Cancer

National Comprehensive Cancer Network, Colon Cancer Version 1.2017 Clinical Practice Guidelines in Oncology

The Cancer Genome Atlas Research Network et al The Cancer Genome Atlas Pan Cancer Analysis Project

Corless et al Tackling Formalin Fixed, Paraffin Embedded Tumor Tissue with Next Generation Sequencing

Lawrence et al Phase I Clinical Trial of Alitretinoin and Tamoxifen in Breast Cancer Patients

Gleevec FDA 2001 Approval Letter

Leslie A. Pray Gleevec The Breakthrough in Cancer Treatment

Gleevec FDA 2002 Approval Letter

Gleevec Label

Avastin Highlights of Prescribing Information

Shen et al Utilization Patterns and Trends in Epidermal Growth Factor Receptor (EGFR) Mutation Testing among Patients with Newly Diagnosed Metastatic Lung Cancer

Paez et al EGFR mutations in lung cancer

Pao et al EGF receptor gene mutations are common in lung cancers from ¿¿¿never smokers and correlate with sensitivity of tumors to gefitinib (Iressa) and erlotinib (Tarceva)

Kari et. al Targeting the Epidermal Growth Factor in Cancer

Tanner et. al Amplification of HER 2 in Gastric Carcinoma

Flavell, Keytruda

Richard Simon, Roadmap for Developing and Validating Therapeutically Relevant Genomic Classifiers

Von Hoff et al., Frequency of Potential Therapeutic Targets Identified by IHC and DNA Microarray in Tumors From Patients Who Have Progressed on Multiple Therapeutic Agents

Fuerst, Dan Von Hoffs Karnofsky Lecture Smart Phase I Trials Can Extend Life Beyond The Last 12 Weeks

Haber et al Molecular Targeted Therapy of Lung Cancer EGFR Mutations and Response to EGFR Inhibitors

DC Allred Origins of estrogen receptor alpha positive and estrogen receptor alpha negative human breast cancer

Luchtenborg et al Mutations ins APC CTNNB1 and K Ras Genes and Expression of hMLH1 in Sporadic Colorectal Carcinomas from the Netherlands Cohort Study

Cynthia A. Heinlein and Chawnshang Chang Androgen Receptor in Prostate Cancer

National Comprehensive Cancer Network Breast Cancer Version 4.2017 Clinical Practice Guidelines in Oncology

Adrienne Burke Foundation Medicine Personalizing Cancer Drugs

Inokuchi et al Abnormality of C Kit Oncoprotein in Certain Patients With Chronic Myelogenous Leukemia Potential Clinical Significance

Patent Owner's Response

Corless et al PDGFRA Mutations in Gastrointestinal Stromal Tumors

Kanaya et al Frequent Hypermethylation of MLH1 Promoter in Normal Endometrium of Patients with Endometrial Cancers

Rodriguez Viciana et al Cancer Targets in the Ras Pathway

Staker et al The Mechanism of Topoisomerase I Poisoning By a Camptothecin Analog

Mace L. Rothenberg Irinotecan CPT 11 Recent Developments and Future Directions

Agoff et al Androgen Receptor Expression in Estrogen Receptor Negative Breast Cancer

Joyce A. O'Shaughnessy Molecular Signatures Predict Outcomes of Breast Cancer

Ahmed Ashour Ahmed and James D. Brenton Microarrays and Breast Cancer Clinical Studies

Shi et al QA/QC Challenges and Pitfalls Facing the Microarray Community and Regulatory Agencies

FoundationOne Sample Report

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About Us Fulfilling the Promise of Precision Medicine

A Culture Dedicated to Advancing Cancer Care

Zhou et al PTEN Mutational Spectra Expression Levels and Subcellular Localization in Microsatellite Stable and Unstable Colorectal Cancers

B. Ramanath Rao and Berend J. Slotman Endocrine Factors in Common Epithelial Ovarian Cancer

Wisniewski et al Characterization of Potent Inhibitors of the Bcr Abl and the c Kit Receptor Tyrosine Kinases

Ohta et al Fluorescence in Situ Hybridization Evaluation of cerbB 2 Gene Amplification and Chromosomal Anomalies in Bladder Cancer

Deposition Transcript of Paul Spellman PhD

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Ferrera Declaration

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Declaration of Sylvia Hall-Ellis, Ph.D.

Joint Stipulation to Modify Due Dates 1-3

Decision Granting Petitioner's Motions for Pro Hac Vice Admission of Shirley X. Li Cantin

Decision Granting Petitioner's Motions for Pro Hac Vice Admission of David B. Bassett

Granting Petitioner's Motion to File Supplemental Information

Exhibit 3003

Petitioner's Updated Mandatory Notices

Exhibit 3002

ORDER Conduct of the Proceeding

Corrected Affidavit of Christopher Butler

Declaration Of David B. Bassett In Support Of Motion For Admission Pro Hac Vice

Petitioners Motion For Admission Pro Hac Vice Of David B. Bassett

Petitioners Motion For Admission Pro Hac Vice Of Shirley X. Li Cantin

Declaration Of Shirley X. Li Cantin In Support Of Motion For Admission Pro Hac Vice

Patent Owner's Opposition to Petitioner's Motion to Submit Supplemental Information

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PETITIONER'S MOTION TO SUBMIT SUPPLEMENTAL INFORMATION

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Declaration of Mark Abramovitz

Mark Abramovitz & Brian Leyland-Jones, A Systems Approach to Clinical Oncology: Focus on Breast Cancer, 4 Proteome Sci.

Jian-Bing Fan et al., Multiplexed RNA Profiling of Paraffin Samples - Assay Tutorial: Reproducible Gene Expression from Degraded RNAs Using the DASL Assay, 25 Genetic Eng'g News 28

Fixed on Expression, 4 Bio-IT World 22

Seminar Notice, Sunnybrook Research Institute, Applying Genomic and Proteomic Platforms Towards the Individualization of Treatment for Breast Cancer Patients

Illumina Seminar Series Notice, University of Florida, From Whole-Genome to Whole-Solution, Disease Analysis Tools for the Next Generation

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EXPUNGED

EXPUNGED

EXPUNGED

EXPUNGED

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Order - Conduct of the Proceedings - 37 CFR 42.5

Notice of Deposition of Paul T. Spellman, Ph.D

Patent Owner's Objections to Evidence

Trial Instituted Document

Scheduling Order

PANEL CHANGE ORDER Conduct of the Proceedings 37 C.F.R. ¿¿ 42.5

Patent Owner's Sur-Reply

Petitioner's Reply to Patent Owner's Preliminary Response

Conduct of the Proceeding 37 C.F.R. sec. 42.5

Ex 3001

Wakelee, et al. Optimizing First Line Treatment Options for Patience with Advanced NSCLC

Seena Magowitz Foundation, Dr. Daniel Von Hoff Wins ASCO Award

File Excerpt of U.S. Patent No. 8,880,350

Patent Owner's Preliminary Response

Horstmann, et al. Risks and Benefits of Phase 1 Oncology Trials, 1991 through 2002

Declaration of Michael Castro, submitted during prosecution of U.S. Patent App. 11/750,721

Benson, et al. American Society of Clinical Oncology Recommendations on Adjuvant Chemotherapy for Stage II Colon Cancer

National Comprehensive Cancer Network, Breast Cancer Clinical Practice Guidelines in Oncology

Leyland-Jones, Trastuzumab: Hopes and Realities

National Comprehensive Cancer Network, Colon Cancer Clinical Practice Guidelines in Oncology

Declaration of Sandeep K. Reddy, submitted during prosecution of U.S. Patent App. 14/249,261

U.S. Patent No. 8,880,350

U.S. Patent No. 9,372,193

U.S. Patent No. 9,292,660

Von Hoff, Pilot Study Using Molecular Profiling of Patients Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers

Doroshow, et al. Selecting Systemic Cancer Therapy One Patient at a Time

Femara Prescribing Information

Tamoxifen Prescribing Information

The Translational Genomics Research Institute, Dr. Daniel Von Hoff Presented with Top Genomics Award from Scripps

Foundation Medicine, Inc., Foundation One Technical Information and Test Overview

Foundation Medicine, Inc., Form 10-K, filed March 3, 2017 for the period ending December 31, 2016

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Notice of Accord Filing Date

Patent Owner's Power of Attorney

Patent Owner's Mandatory Notices

U.S. Patent No. 9,383,365

PCT Publication No. WO 03/017038 (published Feb. 27, 2003) ("Lu")

U.S. Patent Publication No. 2002/0150966 ("Muraca")

Charles Sawyers, Targeted cancer therapy, 432 Nature 294 (2004)

File History U.S. App. No. 14/473,871

Illumina Gene Expression Profiling, Technical Bulletin, RNA Profiling with the DASL Assay (2005) ("Illumina")

Amy L. McDoniels-Silvers et al., Differential Expression of Critical Cellular Genes in Human Lung Adenocarcinomas and Squamous Cell Carcinomas in Comparison to Normal Lung Tissues, 4 Neoplasia 141 (2002)

Robert Langreth & Michael Waldholz, New Era of Personalized Medicine Targeting Drugs For Each Unique Genetic Profile, 4 The Oncologist 426 (1999)

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Jackson B. Gibbs, Anticancer drug targets: growth factors and growth factor signaling, 105 J. Clinical Investigation 9 (2000)

Gleevec™ (imatinib mesylate) Prescribing Information (Jan. 22, 2002)

Herceptin (trastuzumab) Prescribing Information (Sept. 1998)

Iressa (gefitinib) Prescribing Information (May 2, 2003)

Tarceva (erlotinib) Prescribing Information (Nov. 18, 2004)

James Moyer et al., Induction of Apoptosis and Cell Cycle Arrest by CP-358,774, an Inhibitor of Epidermal Growth Factor Receptor Tyrosine Kinase, 57 Cancer Research 4838 (1997)

Genomics and Personalized Medicine Act of 2006, S. 3822, 109th Cong.

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Henry Q. Xiong & James L. Abbruzzese, Epidermal growth factor receptor-targeted therapy for pancreatic cancer, 29 Seminars in Oncology 31 (2002)

Erbitux (cetuximab) Prescribing Information (Feb. 12, 2004)

ClinicalTrials.gov, Study of TARCEVA (Erlotinib) as Adjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma, available at https://clinicaltrials.gov/ct2/show/NCT01515137

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Atul J. Butte et al., Discovering functional relationships between RNA expression and chemotherapeutic susceptibility using relevance networks, 97 PNAS 12182 (2000)

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Jeremy Gollub et al., The Stanford Microarray Database: data access and quality assessment tools, 31 Nucleic Acids Research 94 (2003)

Erbitux (cetuximab) Prescribing Information (Mar. 1, 2006)

Thomas M. Daly et al., Precision Profiling and Components of Variability Analysis for Affymetrix Microarray Assays Run in a Clinical Context, 7 J. Molecular Diagnostics 404 (2005)

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Xiaojun Zhao et al., Homozygous Deletions and Chromosome Amplifications in Human Lung Carcinomas Revealed by Single Nucleotide Polymorphism Array Analysis, 65 Cancer Research 5561 (2005)

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Complaint

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Petition for Inter Partes Review of U.S. Pat. No. 9,383,365