iRhythm, Inc. vs Welch Allyn, Inc. et al.

Authorized Response to Director Review Request

Email, Subject_IPR2025-00363, -00374, -00376, -00377, -00378 Director Review Requests

iRhythm's Request for Director Review

Exhibit 3100

Ex. 3001

Director Discretionary Decision: Deny

Petitioner's Response to Patent Owner's Request for Discretionary Denial

Exhibit 1067-ISBN Database Record Concerning Ex. 1035

Exhibit 1068-Claim Construction Hearing Transcript, Nuance Commc’ns, Inc. v. MModal, LLC, C.A. No. 17-1484 (MN) (D. Del.), April 11, 2019 (Dkt. 226)

Exhibit 1069-Minute Order regarding Motion to Stay Pending Inter Partes Review, MQ Gaming, LLC v. Lego Sys., Inc., C.A. No. 19-00905 (MN) (D. Del.), March 17, 2021

Exhibit 1070-Defendants’ Opening Brief in Support of Motion to Stay Pending Inter Partes Review, MQ Gaming, LLC v. Lego Sys., Inc., C.A. No. 19-00905 (MN) (D. Del.), Feb. 18, 2021 (Dkt. 145)

Exhibit 1071-Scheduling Order, Welch Allyn, Inc. v. iRhythm Techs., Inc., C.A. No. 24-224 (MN) (D. Del.), April 15, 2025 (Dkt. 25)

Exhibit 1072-Docket Navigator® Motion Success Statistics for Motions to Stay Pending IPR (Post-Institution), Hon. Maryellen Noreika

Patent Owner's Preliminary Response

Ex. 2013 - Declaration of Dr. Brian Anthony

Patent Owner's Argument for Discretionary Denial

Ex. 2001 - IDS, 5/18/2015

Ex. 2002 - IDS, 8/7/2013

Ex. 2003 - iRhythm Amended Answer (Bardy)

Ex. 2004 - 26(f) Report from Bardy v. iRhythm

Ex. 2005 - Scheduling Order in Welch Allyn v. iRhythm

Ex. 2006 - Notice of Service of Party Discovery (ECF 26)

Ex. 2007 - Notice of Service of Party Discovery (ECF 27)

Ex. 2008 - Notice of Service of Third-Party Discovery (ECF 41)

Ex. 2009 - Notice of Service of Third-Party Discovery Responses (ECF 47)

Ex. 2010 - Excerpt from Zenious et al., BioDesign

Ex. 2011 - Notice of Service of Third-Party Discovery (ECF 48)

Notice: Extending Deadline for Discretion Briefing

Notice: NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

Patent Owner's Power of Attorney

Patent Owner's Mandatory Notices

Exhibit 1001 - U.S. Patent No. 8,214,007

Exhibit 1002 - File History of U.S. Patent No. 8,214,007 (Part 1 of 2)

Exhibit 1002 - Part 2 of 2

Exhibit 1003- U.S. Patent No. 8,965,492

Exhibit 1004-File History of U.S. Patent No. 8,965,492

Exhibit 1005-U.S. Patent No. 9,155,484

Exhibit 1006-File History of U.S. Patent No. 9,155,484

Exhibit 1007-U.S. Patent No. 10,159,422

Exhibit 1008-File History of U.S. Patent No. 10,159,422

Exhibit 1009-Expert Declaration Jason Heikenfeld

Exhibit 1010-Curriculum Vitae of Jason Heikenfeld, Ph.D

Exhibit 1011-U.S. Patent Publication No. 2003/0149349 ("Jensen")

Exhibit 1012-Cert Translation of JP Pat. Pub. JP2004/121360 ("Matsumura")

Exhibit 1013-U.S. Patent No. 4,763,660 ("Kroll")

Exhibit 1014-U.S. Patent Publication No. 2005/0096513 (“Ozguz”)

Exhibit 1015-U.S. Patent No. 6,238,338 (“DeLuca”)

Exhibit 1016-C.J. Harland et al., Electric Potential Probes ("Harland")

Exhibit 1017-U.S. Patent No. 6,223,080 ("Thompson")

Exhibit 1018-U.S. Patent No. 4,280,507

Exhibit 1019-PCT Publication WO 1987/01024 A1

Exhibit 1020-J Adamec & R Adamec, ECG Holter, Guide to Electrocardiographi

Exhibit 1021-G Kalahasty et al., A Brief History of Remote Cardiac Monitor

Exhibit 1022-E Chung, Ambulatory Electrocardiography Holter Monitor

Exhibit 1023-U.S. Patent Publication No. 2006/0224072

Exhibit 1024-NLM, In brief: What is an electrocardiogram (ECG)?

Exhibit 1025-M AlGhatrif & J Lindsay, A Brief Review: History to Understand

Exhibit 1026-R Grant, Spatial Vector Electrocardiography

Exhibit 1027-ACLS Medical Training, The Basics of ECG

Exhibit 1028-Euan A. Ashley & Josef Niebauer, Cardiology Explained

Exhibit 1029-ACC/AHA Guidelines for Ambulatory Electrocardiography

Exhibit 1030-Mike Cadogan, Norman J. Holter (2022)

Exhibit 1031-Joel Morganroth, Ambulatory Holter Electrocardiography

Exhibit 1032-N Thakor, From Holter Monitors to Automatic Defibrillators

Exhibit 1033-PCT Publication WO 2008/005015 A1

Exhibit 1034-U.S. Patent No. 6,454,708

Exhibit 1035-R.S. Khandpur, Printed Circuit Boards (Part 1 of 2)

Exhibit 1035-Part 2 of 2

Exhibit 1036-AAMI, Cardiac monitors, heart rate meters, and alarms

Exhibit 1037-P.J.B. Hubner, Which Disposable Chest Electrode?

Exhibit 1038-V. Trend, Are ECG Welsh cup electrodes effectively cleaned?

Exhibit 1039-U.S. Patent Publication No. 2003/0069510

Exhibit 1040-Devices@FDA: Dexcom STS Continuous Monitors, U.S. Food & Drug

Exhibit 1041-AAMI, Ambulatory Electrocardiographs (Part 1 of 2)

Exhibit 1041-Part 2 of 2

Exhibit 1042-D Prutchi & M Norris, Design and Development of Medical Elect

Exhibit 1043-Roger A. Freedman & Hugh D. Young, University Physics

Exhibit 1044-B Bowman & E Schuck, Medical Instruments and Devices Used in

Exhibit 1045-Bert-Uwe Kohler, The Principles of Software QRS Detection

Exhibit 1046-B Burkhardt, The Future of Electrocardiograph Telemetry System

Exhibit 1047-P. Nolan, Sterile Medical Device Package Development

Exhibit 1048-L Dallett & W Donaldson, Plastics and Adhesives: A Guide

Exhibit 1049-N.V. Thakor & J.G Webster, Electrode studies for the long-term

Exhibit 1050-Jiapu Pan & W Tompkins, A Real-Time QRS Detection Algorithm

Exhibit 1051-R Gregorian & W Nicholson, Jr., A Switched-Capacitor High-Pass

Exhibit 1052-J. Terry Caves et al., Sampled Analog Filtering Using Switched

Exhibit 1053-Klaus-Peter Hoffmann & R Ruff, Flexible dry surface-electrodes

Exibit 1054-Tsuyoshi Kato et al., An Application of Capacitive Electrode

Exhibit 1055-U.S. Patent Publication No. 2003/0055460

Exhibit 1056-Tilak Shah, Polyurethane Thin-Film Welding for Medical Device

Exhibit 1057-Creative Materials, Medical Device Specialty Inks and Films

Exhibit 1058-Aoife Morrin, Electrochemical Characterization of Commercial

Exhibit 1059-V.W. Greene, Reuse of Disposable Medical Devices

Exhibit 1060-Robert A. Millikan & E.S. Bishop, Elements of Electricity

Exhibit 1061-Maeona Jacobs, Sources of Measurement Error in Noninvasive

Exhibit 1062-Michael R. Neuman, Biopotential Electrodes

Exhibit 1063-Jaehoon Kim, Implanted Antennas for Medical Wireless

Exhibit 1064-J. Muhlsteff et al., Wearable approach for continuous ECG

Exhibit 1065-Japanese Patent Publication No. JP2004/121360

Exhibit 1066-Certificate of Translation for Japanese Pat Pub JP2004/121360

Petition for Inter Partes Review Under 35 U.S.C. § 312 & 37 C.F.R. § 42.104

Petitioner's Power of Attorney