Laboratory Corporation of America Holdings vs Quest Diagnostics Investments LLC et al.

Trial Certificate Checklist

Other: fed circuit mandate

Other: other court decision

Patent Owner's Notice of Appeal

Termination Decision Document

Hearing Transcript

Petitioner's Demonstratives

Patent Owner's Hearing Demonstratives

Patent Owner's Updated Hearing Demonstratives

Granting Request for Oral Argument 37 C.F.R. § 42.70

Petitioner's Request for Oral Argument

Patent Owner's Request for Oral Argument

Patent Owner's Sur-Reply

Patent Owner's Objections to Evidence

Petitioner's Reply to Patent Owner's Response

Supplemental Declaration of Rachel J. Watters

Gillingwater et al., High Throughput Analysis of Plasma Testosterone Using LC-MS/MS

Deposition Transcript of Patrick M. Sluss, Ph.D.

Declaration of Christopher Butler

Soldin & Soldin, Steroid Hormone Analysis by Tandem Mass Spectrometry

Tornoe et al., Population Pharmacokinetic/Pharmacodynamic (PK/PD) Modelling of theHypothalamic-Pituitary-Gonadal Axis Following Treatment with GnRH Analogues

Quest Diagnostics v. Lab. Corp.of Am. Holdings, No. 1:18-CV-01436-UNA - Memorandum Order

Petitioner's Updated Mandatory Notices Pursuant to 37 C.F.R. Section 42.8

Patent Owner's Updated Mandatory Notices

Petitioner's Notice of Deposition of Patrick M. Sluss, PH.D.

Joint Stipulation to Adjust the Scheduling Order

Petitioner's Objections to Evidence Submitted with Patent Owner's Response

Patent Owner's Updated Exhibit List

Declaration of Robert D. Voyksner, Ph.D. in Support of Actavis¿¿¿s Answering Claim Construction Brief in C.A. No. 16-333 (SLR)(SRF)(D. Delaware)

Kushnir, M. M., Rockwood, A. L., Roberts, W. L., Pattison, E. G., Bunker, A. M., Fitzgerald, R. L., & Meikle, A. W., Performance characteristics of a novel tandem mass spectrometry assay for serum testosterone. Clinical Chemistry, 52(1), 120-128 (2006).

Fitzgerald, R. L., et al., Analysis of testosterone in serum using mass spectrometry. In Clinical Applications of Mass Spectrometry (pp. 489-500). Humana Press (2010)

October 31, 2019 Deposition Transcript of Robert L. Fitzgerald, Ph.D.

Declaration of Dr. Patrick M. Sluss, Ph.D. in Support of Patent Owner¿¿¿s Response to Inter Partes Review of U.S. Patent No. 8,409,862

Annesley, T. M., Ion suppression in mass spectrometry. Clinical chemistry, 49(7), 1041-1044 (2003).

Patent Owner's Response

Curriculum Vitae of Robert D. Voyksner, Ph.D.

October 10, 2019 Deposition Transcript of Robert D. Voyksner, Ph.D.

October 16, 2019 Deposition Transcript of Rachel J. Watters

Chambers, E., et al., Systematic and comprehensive strategy for reducing matrix effects in LC/MS/MS analyses. Journal of Chromatography B, 852(1-2), 22-34 (2007).

Stone, J. A., & Fitzgerald, R. L., Liquid Chromatography¿¿¿Mass Spectrometry Education for Clinical Laboratory Scientists. Clinics in laboratory medicine, 38(3), 527-537 (2018).

Sciex API LC/MS/MS TurboIonSpray Ion Source Manual (2006).

Biotage SPE Method Development Recommendations

Chapter 1: Overview of Solid-Phase Extraction from Thurman, E. M., Solid-phase extraction: principles and practice. Chemical analysis; 147 (1998).

Wang, C., et al. Measurement of total serum testosterone in adult men: comparison of current laboratory methods versus liquid chromatography-tandem mass spectrometry. The Journal of Clinical Endocrinology & Metabolism 89.2: 534-543 (2004).

Carvalho, V. M. The coming of age of liquid chromatography coupled to tandem mass spectrometry in the endocrinology laboratory. Journal of Chromatography B, 883, 50-58 (2012).

NCCLS, Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. 1-39 (2004).

Owen, L. J., and B. G. Keevil. Testosterone measurement by liquid chromatography tandem mass spectrometry: the importance of internal standard choice. Annals of Clinical Biochemistry 49.6: 600-602 (2012).

Soma, L. R., et al. Plasma concentrations of testosterone and 19¿¿¿nortestosterone (nandrolone) in the nonracing intact male horse by liquid chromatography¿¿¿mass spectrometry. Journal of veterinary pharmacology and therapeutics 31.6 587-590 (2008).

Rosner, W., et al. Utility, limitations, and pitfalls in measuring testosterone: an Endocrine Society position statement. The Journal of Clinical Endocrinology & Metabolism 92.2: 405-413 (2006).

Ho, E. N., et al., Control of the misuse of testosterone in castrated horses based on an international threshold in plasma. Drug Testing and Analysis, 7(5): 414-419 (2015).

Van Eeckhaut, A., et al. Validation of bioanalytical LC¿¿¿MS/MS assays: evaluation of matrix effects. Journal of Chromatography B, 877(23), 2198-2207 (2009).

Fitzgerald RL, et al. Analysis of Testosterone in Serum Using Mass Spectrometry. Methods Mol Biol, 603:489-500 (2010).

Patent Owner's Notice of Deposition of Dr. Robert L. Fitzgerald

Patent Owner's Notice of Deposition of Rachel J. Watters

Patent Owner's Notice of Deposition of Dr. Robert Voyksner

Patent Owner's Objections to Evidence

Institution of Inter Partes Review 35 U.S.C. sec 314(a)

SCHEDULING ORDER

ORDER Granting Patent Owner¿¿¿s Motion for Pro Hac Vice Admission of Thomas H. Wintner

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

Unopposed Motion of Quest Diagnostics Investments LLC for Pro Hac Vice Admission of Thomas H. Wintner

Petitioner's Updated Exhibit List

Transcript of Teleconference Proceedings, held June 27, 2019

Petitioner's Reply to Patent Owner's Preliminary Response

Declaration of Dr. Robert Voyksner

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

Declaration of Thomas H. Wintner

Patent Owner's Preliminary Response

Excerpt from the File History of U.S. Patent No. 7,348,137: January 10, 2007 Non-Final Office Action.

Excerpt from the File History of U.S. Patent No. 7,754,419: April 29, 2009 Non-Final Office Action.

Patent Owner's Updated Mandatory Notices

Excerpt from the File History of U.S. Patent No. 6,977,143: March 4, 2005 Non-Final Office Action.

Excerpt from the File History of U.S. Patent No. 7,754,419: February 18, 2010 Final Rejection.

Patent Owner's Power of Attorney

Patent Owner's Mandatory Notices

Notice of Accord Filing Date

Petition for Inter Partes Review

Draisci et al., Quantitation of Anabolic Hormones and Their Metabolites in Bovine Serum and Urine by Liquid Chromatography-Tandem Mass Spectrometry, J. Chromatog

Fitzgerald and Herold, Serum Total Testosterone: Immunoassay Compared with Negative Chemical Ionization Gas Chromatography, Mass Spectrometry, Clin. Chem

U.S. Patent. No. 6,977,143 to Caulfield et al.

U.S. Patent. No. 7,348,137 to Caulfield et al.

U.S. Patent. No. 8,318,418 to Caulfield et al.

U.S. Patent. No. 8,329,392 to Caulfield et al.

Patent Owner Response dated June 11, 2007 for U.S. Patent No. 7,348,137

Patent Owner Response dated March 16, 2010 for U.S. Patent No. 7,754,419

Patent Owner Response dated October 28, 2009 for U.S. Patent No. 7,754,419

U.S. Patent. No. 8,409,862 to Caulfield et al.

Declaration of Robert L. Fitzgerald, Ph.D., DABCC

Clarke et al., Determination of Suppressed Testosterone Levels in Human Serum by LC-MS/MS, Proceedings of the 49th ASMS Conference on Mass Spectrometry and Allied Topics, Chicago, Illinois

U.S. Patent. No. 7,754,419 to Caulfield et al.

Office Action dated January 10, 2007 for U.S. Patent No. 7,348,137

Declaration of Christopher Butler

Armbruster and Pry, Limit of Blank, Limit of Detection and Limit of Quantitation, Clin. Biochem. Rev. 29:S49-S52 (Suppl. 1 2008)

Herbert and Johnstone, Mass Spectrometry Basics, CRC Press LLC, Boca Raton, Florida, pp. 225-35, 245-52, 261-68, and 413-15 (2002)

Power of Attorney

Examiner¿¿¿s Amendment dated April 12, 2010 for U.S. Patent No. 7,754,419

File History of U.S. Patent No. 8,409,862

Declaration of Rachel J. Watters

Declaration of Catherine Vassilkova

Taieb et al., Testosterone Measured by 10 Immunoassays and by Isotope-Dilution Gas Chromatography-Mass Spectrometry in Sera from 116 Men, Women, and Children, Clin. Chem. 49(8):1381-95 (2003)

Fuqua et al., Assay of Plasma Testosterone During the First Six Months of Life: Importance of Chromatographic Purification Of Steroids, Clin. Chem. 41(8):1146-49 (1995)

Fitzgerald et al., Broad Spectrum Drug Identification Directly from Urine,, Using Liquid Chromatography-Tandem Mass Spectrometry, Clin. Chem. 45(8):1224-34 (1999)

Legrand et al., Measurement of plasma testosterone by gas chromatography-negative-ion mass spectrometry using pentafluoropropionic derivatives, J. Chromatog. 663:187-92, 189 (1995)

Vogeser et al., Liquid Chromatography-Tandem Mass Spectrometry, Application in the Clinical Laboratory, Clin. Chem. Lab. Med. 41(2):117-126, 119 (2003)

U.S. Patent No. 4,452,903 to Lee and Yi