The detailed information for PTAB case with proceeding number IPR2019-00166 filed by Foundation Medicine, Inc. et al. against Caris MPI, Inc. et al. on Nov 6, 2018. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2019-00166
Filing Date
Nov 6, 2018
Petitioner
Foundation Medicine, Inc. et al.
Respondent
Caris MPI, Inc. et al.
Status
Final Written Decision
Respondent Application Number
14187015
Respondent Tech Center
1600
Respondent Patent Number
9292660
Institution Decision Date
May 14, 2019
Termination Date
May 13, 2020

Proceeding Documents

The table below shows documents filed in the case, listing each document name, filing date, document type, and filing party. Tracking these filings indicates the activity of the parties involved in the case, and the types of documents filed can provide insights into the legal strategies being employed.


Document NameFiling DateCategoryFiling Party

Alert me when new update on this case

Other: fed circuit mandate

Sep 16, 2022PAPERBOARD

Other: other court decision

Sep 16, 2022PAPERBOARD

Trial Certificate Checklist

Sep 16, 2022PAPERBOARD

JUDGMENT Granting Request for Adverse Judgment on Remand 37 C.F.R. 42.73(b)

Jun 15, 2022PAPERBOARD

Patent Owner's Request for Adverse Judgment

Jun 3, 2022PAPERPATENT OWNER

Disclaimer in Patent Under 37 CFR 1.321(a) filed on January 12, 2022

Jun 3, 2022EXHIBITPATENT OWNER

Panel Change Order

May 24, 2022PAPERBOARD

Petitioner's Motion for Admission Pro Hac Vice of Jonathan Swisher

Jan 5, 2022PAPERPETITIONER

Declaration of Jonathan Swisher in Support of Petitioner's Motion for Admission Pro Hac Vice

Jan 5, 2022EXHIBITPETITIONER

Petitioner's Updated Exhibit List

Jan 5, 2022PAPERPETITIONER

Order: Other

Jan 3, 2022PAPERBOARD

PETITIONER'S MOTION FOR WITHDRAWAL OF COUNSEL

Dec 16, 2021PAPERPETITIONER

PETITIONER'S UPDATED MANDATORY NOTICES

Dec 16, 2021PAPERPETITIONER

PETITIONER'S POWER OF ATTORNEY

Dec 16, 2021PAPERPETITIONER

EXPUNGED

Jun 16, 2020PAPERPETITIONER

Petitioner's Notice of Cross-Appeal

Jun 16, 2020PAPERPETITIONER

Patent Owner's Notice of Appeal

Jun 2, 2020PAPERPATENT OWNER

Termination Decision Document

May 13, 2020PAPERBOARD

EXPUNGED

May 11, 2020PAPERBOARD

Hearing Transcript

May 11, 2020PAPERBOARD

Petitioner's Updated Mandatory Notices

Mar 27, 2020PAPERPETITIONER

Petitioner's Updated Mandatory Notices And Exhibit List

Feb 10, 2020PAPERPETITIONER

ORDER Oral Hearing 37 C.F.R. ¿¿ 42.70

Jan 23, 2020PAPERBOARD

Patent Owner's Updated Mandatory Notices

Jan 14, 2020PAPERPATENT OWNER

Decision - Granting Patent Owner's Motions for Pro Hac Vice Admission of Jonathan Singer - 37 CFR 42.10

Jan 10, 2020PAPERBOARD

Patent Owner's Sur-Reply

Jan 3, 2020PAPERPATENT OWNER

Petitioner's Request for Oral Argument

Dec 30, 2019PAPERPETITIONER

Patent Owner's Request for Oral Argument

Dec 30, 2019PAPERPATENT OWNER

Patent Owner's Unopposed Motion for Pro Hac Vice Admission of Jonathan Singer

Dec 5, 2019PAPERPATENT OWNER

Declaration of Jonathan Singer

Dec 5, 2019EXHIBITPATENT OWNER

O'Shaughnessy Deposition Transcript Volume 1 10-22-19

Nov 22, 2019EXHIBITPETITIONER

O'Shaughnessy Deposition Transcript Volume 2 10-23-19

Nov 22, 2019EXHIBITPETITIONER

Bender LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Loesch LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Yeakley LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Petitioner's Reply to Patent Owner's Response

Nov 22, 2019PAPERPETITIONER

Chen

Nov 22, 2019EXHIBITPETITIONER

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

Nov 22, 2019EXHIBITPETITIONER

U.S. Pat. No. 9,053,224

Nov 22, 2019EXHIBITPETITIONER

File History Excerpt for U.S. Pat. App. No. 12/658,770

Nov 22, 2019EXHIBITPETITIONER

Penny LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

McGinniss LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Pawlowski LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Alarcon LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Wright LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Bibikova LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Haber NFCR Profile

Nov 22, 2019EXHIBITPETITIONER

Sordella Cold Spring Harbor Laboratory Profile

Nov 22, 2019EXHIBITPETITIONER

Godin-Heymann LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Settleman LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Puzanov

Nov 22, 2019EXHIBITPETITIONER

Gustin

Nov 22, 2019EXHIBITPETITIONER

Mittendorf

Nov 22, 2019EXHIBITPETITIONER

Chudin LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Kwak LinkedIn Profile

Nov 22, 2019EXHIBITPETITIONER

Leyland-Jones NFCR Profile

Nov 22, 2019EXHIBITPETITIONER

Riely

Nov 22, 2019EXHIBITPETITIONER

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

Nov 21, 2019PAPERBOARD

Patent Owner's Updated Mandatory Notices

Oct 18, 2019PAPERPATENT OWNER

Patent Owner's Updated Power of Attorney

Oct 18, 2019PAPERPATENT OWNER

Granting Patent Owner's Motions for Pro Hac Vice Admission of Corrin Drakulich

Oct 15, 2019PAPERBOARD

Granting Patent Owner's Motions for Pro Hac Vice Admission of Christina Brown-Marshall

Oct 15, 2019PAPERBOARD

Declaration of Corrin Drakulich

Oct 4, 2019EXHIBITPATENT OWNER

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

Oct 4, 2019PAPERPATENT OWNER

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

Oct 3, 2019PAPERPATENT OWNER

Declaration of Christina Brown-Marshall

Oct 3, 2019EXHIBITPATENT OWNER

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

Sep 27, 2019PAPERPETITIONER

Petitioner's Updated Mandatory Notices

Sep 18, 2019PAPERPETITIONER

Decision Granting Petitioner's Motions for Pro Hac Vice Admission of Vinita Ferrera

Sep 18, 2019PAPERBOARD

Ferrera Declaration

Sep 13, 2019EXHIBITPETITIONER

Petitioner's Motion For Admission Pro Hac Vice of Vinita Ferrera

Sep 13, 2019PAPERPETITIONER

Patent Owner's Response

Aug 30, 2019PAPERPATENT OWNER

Deposition Transcript of Paul Spellman, Ph.D., Foundation Medicine V. Caris MPI, Inc. July 25, 2019

Aug 30, 2019EXHIBITPATENT OWNER

Expert Declaration of Joyce O¿¿¿Shaughnessy, M.D.

Aug 30, 2019EXHIBITPATENT OWNER

"Dr. Daniel Von Hoff Presented With Top Genomics Award from Scripps" downloaded from the internet at https://www.eurekalert.org/pub_releases/2011-03/ttgrddv031711.php on August 30, 2019

Aug 30, 2019EXHIBITPATENT OWNER

Foundation Medicine, Inc., "Foundation One: Technical Information and Test Overview", downloaded from the internet at www.foundationone.com on March 4, 2019, 2 pages

Aug 30, 2019EXHIBITPATENT OWNER

Hanahan, et al., "The Hallmarks of Cancer," Cell, Vol. 100, 57-70, January 7, 2000

Aug 30, 2019EXHIBITPATENT OWNER

Sorlie, et al., ¿¿¿Repeated Observation of Breast Tumor Subtypes in Independent Gene Expression Sets,¿¿¿ PNAS Vol. 100, No. 14, July 8, 2003, pp. 8418-8423.

Aug 30, 2019EXHIBITPATENT OWNER

National Comprehensive Cancer Network, "Gastric Cancer Clinical Practice Guidelines in Oncology", Journal of the National Comprehensive Cancer Network, Vol. 1, No. 1, January 2003, pp. 27-39

Aug 30, 2019EXHIBITPATENT OWNER

National Comprehensive Cancer Network, "Breast Cancer Clinical Practice Guidelines in Oncology", Journal of the National Comprehensive Cancer Network, Vol. 7, No. 2, February 2009, pp. 122-192

Aug 30, 2019EXHIBITPATENT OWNER

Part 1 of 2 - National Comprehensive Cancer Network, "Non-Small Cell Lung Cancer Clinical Practice Guidelines in Oncology", Journal of the National Comprehensive Cancer Network, Vol. 4, No. 6, July 2006, pp. 547-582

Aug 30, 2019EXHIBITPATENT OWNER

National Comprehensive Cancer Network, "Breast Cancer Version 4.2017 Clinical Practice Guidelines in Oncology", Journal of the National Comprehensive Cancer Network, Vol. 16, No. 3, March 2018, pp. 310-320

Aug 30, 2019EXHIBITPATENT OWNER

The Cancer Genome Atlas Research Network et al., "The Cancer Genome Atlas Pan-Cancer Analysis Project," Nature Genetics, Vol. 45, No. 10, October 2013, pp. 1113-1120

Aug 30, 2019EXHIBITPATENT OWNER

National Comprehensive Cancer Network, "Colon Cancer Version 1.2017 Clinical Practice Guidelines in Oncology", Journal of the National Comprehensive Cancer Network, Vol. 15, No. 3, March 2017, pp. 370-398

Aug 30, 2019EXHIBITPATENT OWNER

Richard Simon, "Roadmap for Developing and Validating Therapeutically Relevant Genomic Classifiers," Journal of Clinical Oncology, Vol. 23, No. 29, October 10, 2005, pp. 7332-7341

Aug 30, 2019EXHIBITPATENT OWNER

National Comprehensive Cancer Network, "Small Cell Lung Cancer Clinical Practice Guidelines in Oncology", Journal of the National Comprehensive Cancer Network, Vol. 4, No. 6, July 2006, pp. 601-622

Aug 30, 2019EXHIBITPATENT OWNER

Shen et al., "Utilization Patterns and Trends in Epidermal Growth Factor Receptor (EGFR) Mutation Testing among Patients with Newly Diagnosed Metastatic Lung Cancer," Clinical Lung Cancer, Vol. 18, No. 4, July 2017, pp. e233-e241

Aug 30, 2019EXHIBITPATENT OWNER

Paez et al., "EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy," Science, Vol. 304, June 4, 2004, pp. 1497-1500

Aug 30, 2019EXHIBITPATENT OWNER

F Loupakis et. al, "KRAS codon 61, 146 and BRAF mutations predict resistance to cetuximab plus irinotecan in KRAS codon 12 and 13 wild-type metastatic colorectal cancer," British Journal of Cancer, Vol. 101, No. 4, July 14, 2009, pp. 715-721

Aug 30, 2019EXHIBITPATENT OWNER

FoundationOne¿¿HEME Technical Specification, downloaded from the internet at https://assets.ctfassets.net/vhribv12lmne/zBxaQC12cScqgsEk8seMO/c32a7d1adf083cb0f5d0c0b2439fdb87/F1H_Technical_Information.pdf on August 28, 2019, 3 pages

Aug 30, 2019EXHIBITPATENT OWNER

FoundationOne¿¿CDX Webpage, downloaded from the internet at https://www.foundationmedicine.com/genomic-testing/foundationone-cdx#overview on August 28, 2019, 12 pages

Aug 30, 2019EXHIBITPATENT OWNER

Part 2 of 2 - National Comprehensive Cancer Network, "Non-Small Cell Lung Cancer Clinical Practice Guidelines in Oncology", Journal of the National Comprehensive Cancer Network, Vol. 4, No. 6, July 2006, pp. 547-582

Aug 30, 2019EXHIBITPATENT OWNER

Corless et al., "Tackling Formalin-Fixed, Paraffin-Embedded Tumor Tissue with Next-Generation Sequencing," Cancer Discovery, January 12, 2012, pp. 23-24

Aug 30, 2019EXHIBITPATENT OWNER

Gleevec¿¿ FDA 2001 Approval Letter downloaded from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021335 on August 19, 2019, 3 pages

Aug 30, 2019EXHIBITPATENT OWNER

Leslie A. Pray, "Gleevec¿¿: The Breakthrough in Cancer Treatment," Nature Education, Vol. 1, 2008, 4 pages

Aug 30, 2019EXHIBITPATENT OWNER

Gleevec¿¿ FDA 2002 Approval Letter downloaded from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021335 on August 19, 2019, 4 pages

Aug 30, 2019EXHIBITPATENT OWNER

Avastin¿¿, Highlights of Prescribing Information downloaded from the internet at https://www.gene.com/download/pdf/avastin_prescribing.pdf on August 15, 2019, 39 pages

Aug 30, 2019EXHIBITPATENT OWNER

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," Journal of Clinical Oncology, Vol. 24, No. 18. Suppl.3

Aug 30, 2019EXHIBITPATENT OWNER

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

Aug 30, 2019EXHIBITPATENT OWNER

Gleevec¿¿ Label, downloaded from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021335 on August 19, 2019, 22 pages

Aug 30, 2019EXHIBITPATENT OWNER

Lynch et al., "Activating mutation in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib," NEJM, Vol. 350, May 20, 2004, Abstract

Aug 30, 2019EXHIBITPATENT OWNER

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)," PNAS, Vol. 101, No. 36, September 7, 2004, pp. 13306-13311

Aug 30, 2019EXHIBITPATENT OWNER

Kari et. al, "Targeting the Epidermal Growth Factor in Cancer," Cancer Research, Vol. 63, January 1, 2003, pp. 1-5

Aug 30, 2019EXHIBITPATENT OWNER

Tanner et. al, "Amplification of HER-2 in Gastric Carcinoma," Annals of Oncology, Vol. 16, 2005, pp. 273-278

Aug 30, 2019EXHIBITPATENT OWNER

Flavell, "Keytruda," Immuno-Oncology News, downloaded from the internet at https://immuno-oncologynews.com/keytrudapembrolizumab/ on August 15, 2019, 8 pages

Aug 30, 2019EXHIBITPATENT OWNER

Yang, "Epidemiology of Lung Cancer Prognosis: Quantity and Quality of Life," Methods Mol Biol., September 17, 2010, Vol. 471, pp. 1-17

Aug 30, 2019EXHIBITPATENT OWNER

Azzoli et. al, "American Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small Cell Lung Cancer," ASCO, January 2010, pp. 39-43

Aug 30, 2019EXHIBITPATENT OWNER

Fuest, "Dan Von Hoff¿¿¿s Karnofsky Lecture: Smart Phase I Trials Can Extend Life Beyond ¿¿¿The Last 12 Weeks,'" Oncology Times ASCO Meeting Reporter Supplement, August 10, 2010, pp. 21-23

Aug 30, 2019EXHIBITPATENT OWNER

Haber et al., "Molecular Targeted Therapy of Lung Cancer: EGFR Mutations and Response to EGFR Inhibitors," Cold Spring Harbor Laboratory Press, Vol. LXX, 2005, pp. 419-426

Aug 30, 2019EXHIBITPATENT OWNER

Sartore-Bianch et al., "PIK3CA Mutations in Colorectal Cancer Associated with Clinical Resistance to EGFR-Targeted Monoclonal Antibodies," Cancer Research, Vol. 69, No. 5, March 1, 2009, pp. 1851-1857

Aug 30, 2019EXHIBITPATENT OWNER

Black et al., "Sensitivity to Epidermal Growth Factor Receptor Inhibitor Requires E-Cadherin Expression in Urothelial Carcinoma Cells", Clinical Cancer Research, Vol. 14, No. 5, March 1, 2008, pp.1478-1486

Aug 30, 2019EXHIBITPATENT OWNER

FoundationOne¿¿Liquid Technical Specification, downloaded from the internet at https://assets.ctfassets.net/vhribv12lmne/3SPYAcbGdqAeMsOqMyKUog/d0eb51659e08d733bf39971e85ed940d/F1L_TechnicalInformation_MKT-0061-04.pdf on August 28, 2019, 2 pages

Aug 30, 2019EXHIBITPATENT OWNER

Patent Owner's Cancellation of Deposition

Aug 6, 2019PAPERPATENT OWNER

Patent Owner's Notice of Deposition of Mark Abramovitz, Ph.D

Jul 30, 2019PAPERPATENT OWNER

Declaration of Sylvia Hall-Ellis, Ph.D.

Jul 29, 2019EXHIBITPETITIONER

Joint Stipulation to Modify Due Dates 1-3

Jul 29, 2019PAPERPATENT OWNER

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

Jul 23, 2019PAPERBOARD

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

Jul 23, 2019PAPERBOARD

Granting Petitioner's Motion to File Supplemental Information

Jul 22, 2019PAPERBOARD

Exhibit 3003

Jul 22, 2019EXHIBITBOARD

Petitioner's Updated Mandatory Notices

Jul 19, 2019PAPERPETITIONER

ORDER Conduct of the Proceeding

Jul 15, 2019PAPERBOARD

Exhibit 3002

Jul 15, 2019EXHIBITBOARD

Corrected Affidavit of Christopher Butler

Jul 15, 2019EXHIBITPETITIONER

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

Jul 3, 2019EXHIBITPETITIONER

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

Jul 3, 2019PAPERPETITIONER

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

Jul 3, 2019EXHIBITPETITIONER

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

Jul 3, 2019PAPERPETITIONER

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

Jul 1, 2019PAPERPATENT OWNER

EXPUNGED

Jun 24, 2019EXHIBITPETITIONER

Mark Abramovitz et al.

Jun 24, 2019EXHIBITPETITIONER

Motion to Submit Supplemental Information

Jun 24, 2019PAPERPETITIONER

Declaration of Mark Abramovitz

Jun 24, 2019EXHIBITPETITIONER

Jian-Bing Fan et al.

Jun 24, 2019EXHIBITPETITIONER

Sunnybrook Seminar Notice

Jun 24, 2019EXHIBITPETITIONER

EXPUNGED

Jun 24, 2019EXHIBITPETITIONER

EXPUNGED

Jun 24, 2019EXHIBITPETITIONER

EXPUNGED

Jun 24, 2019EXHIBITPETITIONER

Bio-It World

Jun 24, 2019EXHIBITPETITIONER

Illumina Seminar Notice

Jun 24, 2019EXHIBITPETITIONER

EXPUNGED

Jun 24, 2019EXHIBITPETITIONER

EXPUNGED

Jun 24, 2019EXHIBITPETITIONER

EXPUNGED

Jun 24, 2019EXHIBITPETITIONER

EXPUNGED

Jun 24, 2019EXHIBITPETITIONER

EXPUNGED

Jun 24, 2019EXHIBITPETITIONER

EXPUNGED

Jun 24, 2019EXHIBITPETITIONER

EXPUNGED

Jun 24, 2019EXHIBITPETITIONER

Order - Conduct of the Proceedings - 37 CFR 42.5

Jun 18, 2019PAPERBOARD

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

Jun 17, 2019PAPERPATENT OWNER

Patent Owner's Objections to Evidence

May 28, 2019PAPERPATENT OWNER

Trial Instituted Document

May 14, 2019PAPERBOARD

Scheduling Order

May 14, 2019PAPERBOARD

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

Apr 8, 2019PAPERBOARD

Patent Owner's Sur-Reply to Petitioner's Reply

Mar 19, 2019PAPERPATENT OWNER

Petitioner's Reply to Patent Owner's Preliminary Response

Mar 12, 2019PAPERPETITIONER

Conduct of the Proceeding

Mar 5, 2019PAPERBOARD

Ex. 3001

Mar 4, 2019EXHIBITBOARD

Patent Owner's Preliminary Response

Feb 15, 2019PAPERPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

Leyland-Jones, Trastuzumab: Hopes and Realities

Feb 15, 2019EXHIBITPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

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

Feb 15, 2019EXHIBITPATENT OWNER

Doroshow, et al. Selecting Systemic Cancer Therapy One Patient at a Time Is There a Role for Molecular Profiling of Individual Patients With Advanced Solid Tumors?

Feb 15, 2019EXHIBITPATENT OWNER

Patent Owner's Mandatory Notices

Nov 19, 2018PAPERPATENT OWNER

Patent Owner's Power of Attorney

Nov 19, 2018PAPERPATENT OWNER

Notice of Accord Filing Date

Nov 15, 2018PAPERBOARD

Foundation Medicine, Inc. Power of Attorney

Nov 6, 2018PAPERPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

NHGRI Seeks Next Generation of Sequencing Technologies (Oct. 14, 2004), https://www.genome.gov/12513210/

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

Nida Iqbal & Naveed Iqbal, Imatinib- A Breakthrough of Targeted Therapy in Cancer, Chemotherapy Research & Practice 1 (2014)

Nov 6, 2018EXHIBITPETITIONER

Herceptin (trastuzumab) Prescribing Information (Sept. 1998)

Nov 6, 2018EXHIBITPETITIONER

S. Scholl, Targeting HER2 in Other Tumor Types, 12 Annals Oncology S81 (2001)

Nov 6, 2018EXHIBITPETITIONER

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)

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

NCI Drug Dictionary, https-//www.cancer.gov/publications/dictionaries/cancer-drug/def/cetuximab

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

Jane E. Staunton et al., Chemosensitivity prediction by transcriptional profiling, 98 PNAS 10787 (2001)

Nov 6, 2018EXHIBITPETITIONER

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)

Nov 6, 2018EXHIBITPETITIONER

Thomas Jarvie, Next generation sequencing technologies, 2 Drug Discovery Today- Technologies 255 (2005)

Nov 6, 2018EXHIBITPETITIONER

Daniel R. Rhodes et al., Large-scale meta-analysis of cancer microarray data identifies common transcriptional profiles of neoplastic transformation and progression, 25 PNAS 9309 (2004)

Nov 6, 2018EXHIBITPETITIONER

H. Parkinson, ArrayExpress a public repository for microarray gene expression data at the EBI, 33 Nucleic Acids Research D553 (2005)

Nov 6, 2018EXHIBITPETITIONER

C.J. Zheng et al., TRMP: a database of therapeutically relevant multiple pathways, 20 Bioinformatics 2236 (2004)

Nov 6, 2018EXHIBITPETITIONER

Daniel R. Rhodes et al., Oncomine- A Cancer Microarray Database and Integrated Data-Mining Platform, 6 Neoplasia 1, 1 (2004)

Nov 6, 2018EXHIBITPETITIONER

Daniel R. Rhodes et al., Oncomine 3.0: Genes, Pathways, and Networks in a Collection of 18,000 Cancer Gene Expression Profiles, 9 Neoplasia 166 (2007)

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

Alexander Statnikov et al., GEMS: A System for Automated Cancer Diagnosis and Biomarker Discovery from Microarray Gene Expression Data, 74 International J. Med. Informatics 491 (2005)

Nov 6, 2018EXHIBITPETITIONER

Timothy R. Hughes et al., Functional Discovery via a Compendium of Expression Profiles, 102 Cell 109 (2000)

Nov 6, 2018EXHIBITPETITIONER

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)

Nov 6, 2018EXHIBITPETITIONER

HUGO Gene Nomenclature Committee Symbol Report: EGFR, available at https://www.genenames.org/cgi-bin/gene_symbol_report?hgnc_id=HGNC:3236

Nov 6, 2018EXHIBITPETITIONER

Jian-Bing Fan et al., A Versatile Assay for High-Throughput Gene Expression Profiling on Universal Array Matrices, 14 Genome Research 878 (2004)

Nov 6, 2018EXHIBITPETITIONER

Jeffrey S. Ross & Geoffrey S. Ginsburg, The Integration of Molecular Diagnostics with Therapeutics: Implications for Drug Development and Pathology Practice, 119 Am. J. Clinical Pathology 26 (2003) (Ross)

Nov 6, 2018EXHIBITPETITIONER

X. Chen et al., TTD: Therapeutic Target Database, 30 Nucleic Acids Research 412 (2002)

Nov 6, 2018EXHIBITPETITIONER

S. Forbes et al., COSMIC 2005, 94 British J. Cancer 318 (2006)

Nov 6, 2018EXHIBITPETITIONER

Justin Lamb et al., The Connectivity Map: Using Gene-Expression Signatures to Connect Small Molecules, Genes, and Disease, 313 Science 1929 (2006)

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

Oxford Dictionary of Biochemistry and Molecular Biology (Oxford University Press, 2d ed. 2006)

Nov 6, 2018EXHIBITPETITIONER

HUGO Gene Nomenclature Committee Symbol Report: ERBB2, available at https://www.genenames.org/cgi-bin/gene_symbol_report?hgnc_id=HGNC:3430

Nov 6, 2018EXHIBITPETITIONER

Business Wire, Illumina Launches DASL Assay and Cancer Panel for Gene Expression Profiling of Paraffin-Embedded Samples (Jan. 13, 2005)

Nov 6, 2018EXHIBITPETITIONER

Marina Bibikova et al., Gene Expression Profiles in Formalin-Fixed, Paraffin-Embedded Tissues Obtained with a Novel Assay for Microarray Analysis, 50 Clinical Chemistry 2384 (2004)

Nov 6, 2018EXHIBITPETITIONER

Marina Bibikova et al., Quantitative Gene Expression Profiling in Formalin-Fixed, Paraffin-Embedded Tissues Using Universal Bead Arrays, 165 American J. Pathology 1799 (2004)

Nov 6, 2018EXHIBITPETITIONER

David S. Wishart et al, DrugBank: a comprehensive resource for in silico drug discovery and exploration, 34 Nucleic Acids Research D668 (2006)

Nov 6, 2018EXHIBITPETITIONER

Timothy K. Egan, Monitoring Patients Undergoing Cancer Therapy, 31 Lab. Med. 666 (2000)

Nov 6, 2018EXHIBITPETITIONER

HUGO Gene Nomenclature Committee Symbol Report: ESR1, available at https://www.genenames.org/cgi-bin/gene_symbol_report?hgnc_id=HGNC:3467

Nov 6, 2018EXHIBITPETITIONER

NIH National Cancer Institute, How Imatinib Transformed Leukemia Treatment and Cancer Research, (updated Apr. 11, 2018) https://www.cancer.gov/research/progress/discovery/gleevec

Nov 6, 2018EXHIBITPETITIONER

Claudia Dreifus, Researcher Behind the Drug Gleevec, N.Y. Times (Nov. 2, 2009), at D4

Nov 6, 2018EXHIBITPETITIONER

Masuko Katoh & Masaru Katoh, Bioinformatics for Cancer Management in the Post-Genome Era, 5 Technology in Cancer Research & Treatment 169 (2006)

Nov 6, 2018EXHIBITPETITIONER

David Stipp, Gene Chip Breakthrough, Fortune Magazine, Mar. 31, 1997, at 56

Nov 6, 2018EXHIBITPETITIONER

Jian-Bing Fan et al., BeadArray-based solutions for enabling the promise of pharmacogenomics, 39 BioTechniques 583 (2005)

Nov 6, 2018EXHIBITPETITIONER

U.S. Patent No. 9,092,392 (the 392 patent)

Nov 6, 2018EXHIBITPETITIONER

G. William Moore et al., A Prototype Internet Autopsy Database: 1625 Consecutive Fetal and Neonatal Autopsy Facesheets Spanning Twenty Years, 120 Archives Pathology Lab. Med. 782 (1996)

Nov 6, 2018EXHIBITPETITIONER

HUGO Gene Nomenclature Committee Symbol Report: CASP8, available at https://www.genenames.org/cgi-bin/gene_symbol_report?hgnc_id=HGNC:1509

Nov 6, 2018EXHIBITPETITIONER

Phillip G. Febbo & Geoffrey S. Ginsburg, Personalized diagnostic and therapeutic strategies in oncology, 2 Personalized Medicine 97 (2005)

Nov 6, 2018EXHIBITPETITIONER

Dan L. Longo, Imatinib Changed Everything, 376 New England J. Med. 982 (2017)

Nov 6, 2018EXHIBITPETITIONER

Federico Cappuzzo et al., Clinical experience with gefitinib: An update, 58 Critical Reviews in Oncology/Hematology 31 (2006)

Nov 6, 2018EXHIBITPETITIONER

Complaint

Nov 6, 2018EXHIBITPETITIONER

Andreas Gnirke et al., Solution hybrid selection with ultra-long oligonucleotides for massively parallel targeted sequencing, 27 Nature Biotechnology 182 (2009)

Nov 6, 2018EXHIBITPETITIONER

Timothy Ley et al., DNA sequencing of a cytogenetically normal acute myeloid leukemia genome, 456 Nature 66 (2008)

Nov 6, 2018EXHIBITPETITIONER

Ashish Gautam et al., RRM1-induced metastasis suppression through PTEN-regulated pathways, 22 Oncogene 2135 (2003)

Nov 6, 2018EXHIBITPETITIONER

HUGO Gene Nomenclature Committee Symbol Report: CTNNB1, available at https://www.genenames.org/cgi-bin/gene_symbol_report?hgnc_id=HGNC:2514

Nov 6, 2018EXHIBITPETITIONER

U.S. Patent No 8,768,629 (the 629 patent)

Nov 6, 2018EXHIBITPETITIONER

Degeng Wang, Discrepancy between mRNA and protein abundance: Insight from information retrieval process in computers, 32 Computational Biology & Chemistry 462 (2008)

Nov 6, 2018EXHIBITPETITIONER

Yardena Samuels et al., High Frequency of Mutations of the PIK3CA Gene in Human Cancers, 304 Science 554 (2004)

Nov 6, 2018EXHIBITPETITIONER

Hong-Guang Xie & Felix W. Frueh, Pharmacogenomics steps toward personalized medicine, 2 Personalized Medicine 325 (2005)

Nov 6, 2018EXHIBITPETITIONER

David J. Sugarbaker et al., Transcriptome sequencing of malignant pleural mesothelioma tumors, 105 PNAS 3521 (2008)

Nov 6, 2018EXHIBITPETITIONER

Andreas Gnirke et al., Solution hybrid selection with ultra-long oligonucleotides for massively parallel targeted sequencing, 27 Nature Biotechnology 182, Supplementary Figures and Tables (2009)

Nov 6, 2018EXHIBITPETITIONER

U.S. Patent Publication No. 2008/0014146 (Von Hoff)

Nov 6, 2018EXHIBITPETITIONER

Alberto Bardelli & Victor E. Velculescu, Mutational analysis of gene families in human cancer, 15 Current Opinion in Genetics & Development 5 (2005)

Nov 6, 2018EXHIBITPETITIONER

ThermoFisher Scientific, Overview of Immunohistochemistry (IHC)

Nov 6, 2018EXHIBITPETITIONER

HUGO Gene Nomenclature Committee Symbol Report: PIK3CA, available at https://www.genenames.org/cgi-bin/gene_symbol_report?hgnc_id=HGNC:8975

Nov 6, 2018EXHIBITPETITIONER

Gerold Bepler, Pharmacogenomics: A reality or still a promise?, 54 Lung Cancer S3 (2006)

Nov 6, 2018EXHIBITPETITIONER

HUGO Gene Nomenclature Committee Symbol Report: BRAF, available at https://www.genenames.org/cgi-bin/gene_symbol_report?hgnc_id=HGNC:1097

Nov 6, 2018EXHIBITPETITIONER

HUGO Gene Nomenclature Committee Symbol Report: RAF1, available at https://www.genenames.org/cgi-bin/gene_symbol_report?hgnc_id=HGNC:9829

Nov 6, 2018EXHIBITPETITIONER

Tobias Sjoblom et al., The Consensus Coding Sequences of Human Breast and Colorectal Cancers, 314 Science 268, Supporting Material (2006), available at http://science.sciencemag.org/content/suppl/2006/10/24/1133427. DC1

Nov 6, 2018EXHIBITPETITIONER

Tobias Sjoblom et al., The Consensus Coding Sequences of Human Breast and Colorectal Cancers, 314 Science 268 (2006)

Nov 6, 2018EXHIBITPETITIONER

Tobias Sjoblom et al., The Consensus Coding Sequences of Human Breast and Colorectal Cancers, 314 Science 268, Table S1 (2006), available at http://science.sciencemag.org/content/suppl/2006/10/24/1133427. DC1

Nov 6, 2018EXHIBITPETITIONER

Tobias Sjoblom et al., The Consensus Coding Sequences of Human Breast and Colorectal Cancers, 314 Science 268, Table S3 (2006), available at http://science.sciencemag.org/content/suppl/2006/10/24/1133427. DC1

Nov 6, 2018EXHIBITPETITIONER

Tobias Sjoblom et al., The Consensus Coding Sequences of Human Breast and Colorectal Cancers, 314 Science 268, Table S5 (2006), available at http://science.sciencemag.org/content/suppl/2006/10/24/1133427. DC1

Nov 6, 2018EXHIBITPETITIONER

Tobias Sjoblom et al., The Consensus Coding Sequences of Human Breast and Colorectal Cancers, 314 Science 268, Table S6 (2006), available at http://science.sciencemag.org/content/suppl/2006/10/24/1133427. DC1

Nov 6, 2018EXHIBITPETITIONER

Olena Morozova & Marco A. Marra, Applications of next-generation sequencing technologies in functional genomics, 92 Genomics 255 (2008)

Nov 6, 2018EXHIBITPETITIONER

Tobias Sjoblom et al., The Consensus Coding Sequences of Human Breast and Colorectal Cancers, 314 Science 268, Tables S2A and S2B (2006), available at http://science.sciencemag.org/content/suppl/2006/10/24/1133427. DC1

Nov 6, 2018EXHIBITPETITIONER

Tobias Sjoblom et al., The Consensus Coding Sequences of Human Breast and Colorectal Cancers, 314 Science 268, Table S4 (2006), available at http://science.sciencemag.org/content/suppl/2006/10/24/1133427. DC1

Nov 6, 2018EXHIBITPETITIONER

U.S. Provisional Application No. 61/170,565

Nov 6, 2018EXHIBITPETITIONER

U.S. Provisional Application No. 61/105,335

Nov 6, 2018EXHIBITPETITIONER

HUGO Gene Nomenclature Committee Symbol Report- KIT, available at https-//www.genenames.org/cgi-bin/gene_symbol_report?hgnc_id=HGNC-6342

Nov 6, 2018EXHIBITPETITIONER

HUGO Gene Nomenclature Committee Symbol Report- KRAS, available at https-//www.genenames.org/cgi-bin/gene_symbol_report?hgnc_id=HGNC-6407

Nov 6, 2018EXHIBITPETITIONER

Affidavit of Christopher Butler

Nov 6, 2018EXHIBITPETITIONER

U.S. Provisional Application No. 61/217,289

Nov 6, 2018EXHIBITPETITIONER

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)

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

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

Nov 6, 2018EXHIBITPETITIONER

U.S. Patent No. 9,292,660 to Von Hoff et al. (660 patent)

Nov 6, 2018EXHIBITPETITIONER

File History Excerpt

Nov 6, 2018EXHIBITPETITIONER

Gleevec (imatinib mesylate) Prescribing Information (Jan. 2002)

Nov 6, 2018EXHIBITPETITIONER

Fee Authorization

Nov 6, 2018PAPERPETITIONER

Declaration of Paul T. Spellman, Ph.D.

Nov 6, 2018EXHIBITPETITIONER

Petition for Inter Partes Review of U.S. Patent No. 9,292,660

Nov 6, 2018PAPERPETITIONER