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`Washington, D.C.
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`In the Matter of
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`Investigation No.
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`337-TA-1266
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`CERTAIN WEARABLE ELECTRONIC
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`DEVICES WITH ECG FUNCTIONALITY
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`AND COMPONENTS THEREOF
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`________________________________
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` ZOOM DEPOSITION OF COLLIN STULTZ, M.D., Ph.D.,
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`(Reported Remotely via Video & Web Videoconference)
`
` Boston, Massachusetts (Deponent's location)
`
`Thursday, February 3, 2022
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`Volume I
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`STENOGRAPHICALLY REPORTED BY:
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`REBECCA L. ROMANO, RPR, CSR, CCR
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`California CSR No. 12546
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`22
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`Nevada CCR No. 827
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`Oregon CSR No. 20-0466
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`Washington CCR No. 3491
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`JOB NO. 5038471
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`PAGES 1 - 312
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` UNITED STATES INTERNATIONAL TRADE COMMISSION
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` Washington, D.C.
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`In the Matter of Investigation No.
`
` 337-TA-1266
`
`CERTAIN WEARABLE ELECTRONIC
`
`DEVICES WITH ECG FUNCTIONALITY
`
`AND COMPONENTS THEREOF
`
`________________________________
`
` DEPOSITION OF COLLIN STULTZ, M.D., Ph.D.,
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`taken on behalf of the Claimant - AliveCor, with
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`the deponent located in Boston, Massachusetts,
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`commencing at 9:10 a.m., Thursday,
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`February 3, 2022, remotely reported via Video
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`& Web videoconference before REBECCA L. ROMANO,
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`a Certified Shorthand Reporter, Certified
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`Court Reporter, Registered Professional Reporter
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` APPEARANCES OF COUNSEL
`
`(All parties appearing via Web videoconference)
`
`For the Claimant - AliveCor, Inc.:
`
` QUINN EMANUEL URQUHART & SULLIVAN LLP
`
` BY: SEAN S. PAK
`
` BY: KEVIN GU
`
` Attorneys at Law
`
` 50 California Street
`
` 22nd Floor
`
` San Francisco, California 94111
`
` (415) 875-6600
`
` seanpak@quinnemanuel.com
`
` kevingu@quinnemanuel.com
`
`For the Respondents - Apple Inc.:
`
` FISH & RICHARDSON, P.C.
`
` BY: KATHERINE REARDON
`
` Attorneys at Law
`
` 7 Times Square
`
` 20th Floor
`
` New York, New York 10036
`
` (212) 765-5070
`
` kreardon@fr.com
`
`/////
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` APPEARANCES(cont'd)
`
`(All parties appearing via Web videoconference)
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` UNITED STATES INTERNATIONAL TRADE COMMISSION
`
` BY: R. WHITNEY WINSTON
`
` Attorney at law
`
` 500 E Street, SW
`
` Washington, D.C. 20436
`
` (202) 205-2000
`
` whitney.winston@usitc.gov
`
`ALSO PRESENT:
`
` Ramon Peraza, Videographer
`
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` I N D E X
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`DEPONENT EXAMINATION
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`COLLIN STULTZ, M.D., PH.D. PAGE
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`VOLUME I
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` BY MR. PAK 12
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` BY MS. REARDON 295
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` BY MR. PAK 306
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` E X H I B I T S
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`NUMBER PAGE
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` DESCRIPTION
`
`Exhibit 1 Rebuttal Report of Collin 38
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` Stultz, M.D., Ph.D.;
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`Exhibit 2 Article: Identifying 69
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` Clinical and Medical
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` Solutions at the MEDRC
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` Workshop for Medical
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` Electronic Devices and
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` Systems - IEEE Life ...;
`
`/////
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` E X H I B I T S(cont'd)
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`NUMBER PAGE
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` DESCRIPTION
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`Exhibit 3 Expert Report of Collin 82
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` Stultz, M.D., Ph.D.,
`
` Regarding Invalidity of U.S.
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` Patent Nos. 9,572,499,
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` 10,595,731 and 10,638,941;
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`Exhibit 4 Ordering No. 12: Construing 88
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` the Terms of the Asserted
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` Claims of the Patents at
`
` Issue dated November 4, 2021;
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`Exhibit 5 U.S. Patent 10,595,731; 97
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`Exhibit 6 Using Apple Watch for 104
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` Arrhythmia Detection December
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` 2020;
`
`/////
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` E X H I B I T S(cont'd)
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`NUMBER PAGE
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` DESCRIPTION
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`Exhibit 7 Article: A comparison of 146
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` manual electrocardiographic
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` interval and waveform
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` analysis in lead 1 of 12-lead
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` ECG and Apple Watch ECG: A
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` validation study;
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`Exhibit 8 U.S. Paten 10,638,941; 187
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`Exhibit 9 U.S. Patent 9,572,499; 198
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`Exhibit 10 Article - AMON: A Wearable 204
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` Multiparameter Medical
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` Monitoring and Alert System,
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` APL-ALIVE_00082371 -
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` APL-ALIVE_00082383;
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`Exhibit 11 Article: The Advent of 212
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` Clinically Useful Deep
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` Learning;
`
`/////
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` E X H I B I T S
`
`NUMBER PAGE
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` DESCRIPTION
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`Exhibit 12 United States Patent 246
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` 7,460,899 B2;
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`Exhibit 13 International Publication 254
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` Number WO 2004/012033 A2;
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`Exhibit 14 Pub. No.: US 2008/0004904 263
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` A1;
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`Exhibit 15 Pub. No.: US 2013/0030259 276
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` A1;
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`Exhibit 16 Pub No.: US 2009/0234410 A1. 282
`
`/////
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` Boston, Massachusetts; Thursday, February 3, 2022
`
` 9:10 a.m.
`
` ---o0o---
`
` THE VIDEOGRAPHER: Good morning. We are 09:10:52
`
`on the record at 9:10 a.m. on February 3rd, 2022.
`
` This is the video-recorded deposition of
`
`Dr. Collin Stultz in Re Certain Wearable Electronic
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`Devices with ECG Functionality and Components
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`Thereof. This case was filed in the United States 09:11:04
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`International Trade Commission in Washington, DC,
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`Case No. 337-TA-1266.
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` This deposition is being recorded
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`remotely by Veritext. My name is Ramon Peraza,
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`here with our court reporter, Rebecca Romano. We 09:11:25
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`are here from Veritext Legal Solutions at the
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`request of counsel for the complainant.
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` Please note that audio and video
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`recording will take place unless all parties have
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`agreed to go off the record. 09:11:38
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` At this time, Counsel, please identify
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`yourselves for the record and state whom you
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`represent.
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` MR. PAK: Good morning. This is Sean Pak
`
`of Quinn Emanuel representing AliveCor, and with me 09:11:47
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`is Kevin Gu. 09:11:50
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` MS. REARDON: And Katherine Reardon from
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`Fish & Richardson on behalf of respondent, Apple.
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` MR. WINSTON: Good morning. This is
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`Whitney Winston on behalf of the Commission 09:12:04
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`investigative staff.
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` THE VIDEOGRAPHER: The court reporter may
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`now swear in the witness.
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` THE COURT REPORTER: At this time, I will
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`ask counsel to agree on the record that there is no 09:12:10
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`objection to this deposition officer administering
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`a binding oath to the deponent via remote
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`videoconference, starting with the noticing
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`attorney, please.
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` MR. PAK: No objection. 09:12:26
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` MS. REARDON: No objection.
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` MR. WINSTON: No objection.
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` THE COURT REPORTER: If you could raise
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`your right hand for me, please.
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` THE DEPONENT: (Complies.) 09:12:29
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` THE COURT REPORTER: You do solemnly
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`state, under penalty of perjury, that the testimony
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`you are about to give in this deposition shall be
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`the truth, the whole truth and nothing but the
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`truth? 09:12:29
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` THE DEPONENT: I do. 09:12:30
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`
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` COLLIN STULTZ, M.D., Ph.D.,
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`having been administered an oath, was examined and
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`testified as follows:
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` EXAMINATION
`
`BY MR. PAK:
`
` Q. Good morning, Doctor.
`
` A. Good morning.
`
` Q. Can you please --
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` MS. REARDON: Mr. Pak, let me make one 09:12:55
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`quick statement.
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` I just wanted to alert you that
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`Dr. Stultz has his pager with him because he is a
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`practicing doctor. So if for some reason that goes
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`off or if he receives some sort of phone call, we 09:13:07
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`would just ask that we can break so he can attend
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`to that and then we can come back to the session.
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` MR. PAK: Yeah, that's not a problem.
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` MS. REARDON: Thank you.
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` Q. (By Mr. Pak) Good morning, Doctor. 09:13:18
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` Can you please state your name for the
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`record.
`
` A. My name is Collin, C-O-L-L-I-N, Stultz,
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`S-T-U-L-T-Z.
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` Q. And who is your current employer? 09:13:26
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` A. I am currently employed by the 09:13:29
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`Massachusetts Institute of Technology and the
`
`Massachusetts General Hospital.
`
` Q. And what roles do you currently serve for
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`MIT? 09:13:40
`
` A. At MIT, I'm a professor of electrical
`
`engineering and computer science. Professor in
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`medical engineering and sciences, the faculty
`
`member in health sciences and technology. It's
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`actually at Harvard and MIT division. 09:13:54
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` Q. And what role do you play or serve for
`
`the Massachusetts General Hospital?
`
` A. I am a cardiologist.
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` Q. And how long have you been a practicing
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`cardiologist? 09:14:09
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` A. So I began my fellowship, I think it was
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`in -- dating me now. My fellowship was finished
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`about -- about 2000 is when I began. And it was
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`finished about 2003. I became board certified in
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`about 2004. That's my recollection. 09:14:29
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` Q. Doctor, have you ever consulted and
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`worked for -- worked for a technology company,
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`besides MIT and the Mass General Hospital?
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` A. I -- I've served on the scientific
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`advisory board for a few companies. I think 09:14:47
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`several of those are listed in my curriculum vitae. 09:14:50
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` Q. Setting aside your role on scientific
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`advisory boards, have you actually been employed by
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`a technology company?
`
` A. Employed by -- no. No, I -- I can't say 09:15:04
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`that I have. No, I have not.
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` MR. PAK: Okay.
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` MS. REARDON: And -- and Mr. Pak, can --
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`can we take one minute because -- and go off the
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`record? 09:15:13
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` MR. PAK: Sure. I apologize.
`
` THE VIDEOGRAPHER: We are off the record
`
`at 9:15 a.m.
`
` (Recess taken.)
`
` THE VIDEOGRAPHER: We are back on the 09:24:02
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`record at 9:24 a.m.
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` Q. (By Mr. Pak) Welcome back, Doctor.
`
` Have you been deposed before?
`
` A. I have never been deposed before.
`
` Q. Have you ever testified in a court of 09:24:14
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`law?
`
` A. I have never testified in a court of law,
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`no.
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` Q. Okay. Just to remind you today, it's
`
`very important, Dr. Stultz, that you allow me to 09:24:23
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`finish my questions, and I will do the same with 09:24:26
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`respect to your answers.
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` Is that understood?
`
` A. Absolutely.
`
` Q. And we have a videographer here who -- 09:24:32
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`court reporter who's transcribing all the words
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`that are spoken during today's deposition, so it's
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`very important that you provide audible responses
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`to my questions.
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` Is that understood? 09:24:47
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` A. Yes, it is.
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` Q. And is there any reason why you cannot
`
`testify truthfully and accurately to my questions
`
`today?
`
` A. None whatsoever. 09:24:55
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` Q. And you understand, sir, that you
`
`provided expert reports in this investigation?
`
` A. Yes.
`
` Q. You understand that those expert reports
`
`were to contain a complete and accurate record of 09:25:07
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`all the expert opinions that you have formulated in
`
`this investigation.
`
` Do you understand that?
`
` A. That -- that's -- that is correct. They
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`are the accurate reflection of my -- of my opinions 09:25:18
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`with respect to these issues. 09:25:21
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` Q. And did you have a full opportunity to
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`consider all of the evidence in forming those
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`opinions?
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` A. Yes, I did. 09:25:30
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` Q. And did you include all the opinions that
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`you have formed in this investigation in the two
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`reports that you submitted?
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` A. Given the data I had up and to the
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`submission of these reports, I looked at all of 09:25:42
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`those data, and they informed my opinions
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`that are -- that are present in these reports.
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` Q. And sitting here today, are you -- have
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`you formed any opinions with respect to this
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`investigation that you have not included in the 09:25:53
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`expert reports that you have submitted?
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` A. I have not.
`
` Q. Okay. Doctor, have you reviewed the
`
`expert reports of any other experts from Apple in
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`this investigation? 09:26:09
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` A. From Apple, no, I have not.
`
` Q. Have you spoken to any of the Apple
`
`experts in connection with this investigation?
`
` A. Myself and Dr. Picard, and I -- I think
`
`it was counsel from Fish several weeks ago -- spoke 09:26:25
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`on the phone for maybe about 30 or 40 minutes, 09:26:30
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`because Dr. Picard had some questions that were of
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`a medical nature. And so my purpose there were to
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`answer her inquiries.
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` Q. What did Dr. Picard ask you? 09:26:40
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` A. She asked me about some of the things
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`that later appeared in my rebuttal report. I can't
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`recall if my rebuttal report had been submitted at
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`the time. But they were about arrhythmias, the
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`causes of the arrhythmias, the definition of 09:26:53
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`arrhythmias.
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` Q. What did you tell Dr. Picard in response
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`to her questions during that conversation?
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` A. My recollection is she asked me about
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`tachycardia, what tachycardia is, and what 09:27:08
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`circumstances one can have tachycardia and how
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`tachycardia is diagnosed.
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` Q. Anything --
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` A. Oh, I'm -- I'm sorry to interrupt. I
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`was -- and arrhythmia is like tachycardia, just to 09:27:21
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`be precise.
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` Q. And what did you tell her in response to
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`those questions?
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` A. I -- I defined tachycardia. I gave her
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`my definition, which I believe is the standard 09:27:36
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`definition of what an arrhythmia is. 09:27:38
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` We spoke about atrial fibrillation. We
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`spoke about electrocardiography in the setting of
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`diagnosing atrial fibrillation. The utility of a
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`single lead for diagnosing atrial fibrillation. 09:27:50
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`The utility of a 12-lead electrocardiogram in
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`diagnosing atrial fibrillation.
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` And those -- those are my answers to
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`those -- to those questions. That's essentially
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`what I said. That's my recollection. 09:28:04
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` Q. Can you think of anything else that you
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`discussed with Dr. Picard during that discussion?
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` A. I -- I recall there was one question
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`about PPG sensors and ECG sensors. And we had a
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`very brief discussion about the word "compare," and 09:28:23
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`I gave what my impression of the word "compare"
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`meant.
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` Q. What is your impression of the word
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`"compare"?
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` A. So I distinguished between "compare" 09:28:35
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`and -- I'm sorry. Not "compare." I'm sorry. I --
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`just a correction. The word "confirm" was the --
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`was the -- was the discussion.
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` And in my view, that both confirm and
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`determining whether things are consistent involve 09:28:57
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`an analysis where you have two quantities. If they 09:29:01
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`are consistent, that means they are either similar
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`or they are both in agreement with some prior
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`understanding of what they -- what they should --
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`what their behavior should be. 09:29:13
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` And confirmation involves both a
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`consistency analysis, but on top of that, one of
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`the quantities of interest is considered to be the
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`gold standard.
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` So the consistency automatically allows 09:29:28
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`you to make inference about one of the quantities.
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`If the quantities agree, then that is correct. And
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`that was what I -- that is what I related to her.
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` Q. Is what you stated, regarding your
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`understanding of confirmation, the definition that 09:29:44
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`you applied in understanding the claim language of
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`the asserted patents that use the word "confirm"?
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` MS. REARDON: Object to form.
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` THE DEPONENT: So I think this has to be
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`within the -- the context of where it was used. 09:30:01
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`That was my general definition of what it means to
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`confirm.
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` It's a little bit difficult in the -- in
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`the -- in the patent claims that I reviewed because
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`my recollection is where this term comes into play 09:30:19
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`is where you have the data from -- from a PPG 09:30:22
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`sensor which has -- elicits a response or a
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`notification to say that something is abnormal, and
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`then a user is directed to record an
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`electrocardiogram. 09:30:36
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` And I think the -- the -- the wording
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`that I recall is that the -- that is to confirm the
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`presence of an arrhythmia and the -- so strictly
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`speaking, when the PPG tells that there is an
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`abnormality, it's at a particular time, T equals 09:30:53
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`zero. The alert happens afterwards. And the
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`individual in question has to perform an action.
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`They have to take the contralateral hand and touch
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`the watch on the ipsilateral hand, the --
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`ipsilateral to where the watch is placed. 09:31:07
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` And that takes a certain amount of time.
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`So then that ECG recording happens at some later
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`time, delta T. So necessarily, you are getting
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`information at a time that is separate from the
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`time in T equals zero. So confirmation in the -- 09:31:22
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`in that setting was a little mysterious to me.
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` And I think in the -- for that particular
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`region of the -- of the patent, there -- I used the
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`"consistency" more because it didn't make sense to
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`me to use the term "confirm" because the alert 09:31:39
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`happens at a different time of which the 09:31:43
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`electrocardiogram is recorded.
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` Q. (By Mr. Pak) So this is very important,
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`Dr. Stultz. So the claim language uses the word
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`"confirm." 09:31:54
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` You understand that?
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` A. That is my understanding.
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` Q. And I'm asking you, in the context of the
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`way the claim language uses the word "confirm,"
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`what is your understanding of that term? 09:32:06
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` A. So my understanding -- within the context
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`of the claim description, I interpret "confirm" to
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`mean consistency. My discussion with Dr. Picard
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`was a general discussion about what my
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`understanding of the word "confirm" means 09:32:23
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`generally.
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` Q. Understood.
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` So you understand that as far as the
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`claim language of the asserted claims goes, the
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`word "confirm" is used to describe consistency; is 09:32:37
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`that fair?
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` A. That -- that is --
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` MS. REARDON: Object to form.
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` THE DEPONENT: I'm sorry. That --
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`that -- that was my -- that's how I interpreted it 09:32:45
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`within the context of the claims. 09:32:46
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` Q. (By Mr. Pak) And based on your
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`understanding of the word "confirm," as used in the
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`claim language of the asserted claims, you
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`understand that an arrhythmia that has been 09:32:55
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`detected using PPG sensor could be confirmed at a
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`later time by data acquired through an ECG sensor.
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` Do you agree?
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` MS. REARDON: Object to form.
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` THE DEPONENT: No, not -- not 09:33:13
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`necessarily. I -- I don't think that's -- I'm not
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`sure I agree with that.
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` And I say that because these arrhythmias
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`can have very short duration. When I see patients
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`in the -- on the hospital ward, they're on 09:33:25
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`continuous telemetry, and we routinely see very
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`short spurts of atrial fibrillation or other
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`related arrhythmias.
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` So if the question is whether the
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`arrhythmia that elicited -- or the data that 09:33:38
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`elicited the alert, the timing, T equals zero,
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`whether that can be confirmed, you'd have to have
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`an ECG recorded at the same time, in T equals zero.
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` So that -- that's why I interpreted that,
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`because knowing that these arrhythmias can be very 09:33:52
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`short in duration and can subside by the time that 09:33:54
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`the ECG is acquired, that consistency makes more
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`sense to me. That's an understandable phrase
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`using -- interpreting "confirm" to mean
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`consistency. 09:34:09
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` I'm sorry. I hope I answered your
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`question.
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` Q. (By Mr. Pak) I think you are. And I
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`just want to get this very clear. It's an
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`important question, Dr. Stultz. 09:34:17
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` So I asked you to confirm for me that
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`your understanding of the word "confirm," as used
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`in the claim language of the patent, is to be
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`consistent.
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` And you testified that is your 09:34:29
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`understanding, true?
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` A. Yeah.
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` MS. REARDON: Object to form.
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` THE DEPONENT: Sorry. That -- that is --
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`that is correct. 09:34:36
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` Q. (By Mr. Pak) So going back with that
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`understanding of confirmation, as used in the claim
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`language of the patent, you would agree with me
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`that a measurement taken by a PPG sensor at time
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`T zero could be consistent with a detection of 09:34:50
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`arrhythmia produced by an ECG sensor at a later 09:34:58
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`point in time T1.
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` Do you agree?
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` A. Yes.
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` MS. REARDON: Object to form. 09:35:06
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` THE DEPONENT: Sorry.
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` Yes, I do.
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` Q. (By Mr. Pak) And that is how you
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`understand the word "confirm" to be used in the
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`context of the claim language; is that true? 09:35:13
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` A. Yes.
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` MS. REARDON: Object to form.
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` THE DEPONENT: That is how I interpret
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`it.
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` Q. (By Mr. Pak) Thank you. 09:35:21
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` And, Doctor, that conversation you had
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`with Dr. Picard, did that occur before or after
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`Dr. Picard submitted our expert reports in this
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`case?
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` A. My understanding is it was before she 09:35:35
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`submitted her expert report.
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` Q. In your understanding, is Dr. Picard a
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`cardiologist?
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` A. She is not a cardiologist.
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` Q. During the discussion you had with 09:36:04
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`Dr. Picard about the understanding of confirmation, 09:36:06
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`as used in the claim language, did Dr. Picard
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`express any disagreement with you regarding your
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`understanding of that term?
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` MS. REARDON: Object to form. 09:36:21
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` THE DEPONENT: That is not my
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`recollection. It was -- it was a -- it was a
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`discussion -- and I just want to clarify.
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` My recollection is that discussion was a
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`general discussion about what confirm means, and I 09:36:32
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`offered my opinion about confirm and consistency.
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`And it -- I -- I don't recall that that was
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`discussed in the context of any particular claim.
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` Q. (By Mr. Pak) But do you recall whether
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`you and Dr. Picard had any disagreement during that 09:36:47
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`conversation about the --
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` A. I don't --
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` Q. -- about the understanding of
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`confirmation?
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` A. I'm sorry to speak over you. 09:36:58
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` I -- I don't recall. I -- what I recall
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`is that this was a discussion where I was giving --
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`I was answering questions.
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` Q. Let me go back to something else that you
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`discussed with Dr. Picard. You talked about 09:37:17
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`definition of "arrhythmia." 09:37:22
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` Do you recall that?
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` A. Yes, I do.
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` Q. And what is your understanding of
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`arrhythmia? 09:37:29
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` A. So in my rebuttal report, I think I tried
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`to outline a more comprehensive definition of an
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`arrhythmia that is -- more comprehensive than the
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`definition of guidance provided by the court.
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` Having said that, I should say that 09:37:51
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`the -- the definition provided by the court is what
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`I used in my analysis in both of my reports. In
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`that, it is a cardiac condition in which the heart
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`rate -- and I'm paraphrasing -- is irregular or
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`faster or slower than normal. 09:38:05
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` The clinical use of the word "arrhythmia"
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`is a bit broader. And in -- in the sense that
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`it -- it reflects an abnormality in the conduction
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`of impulses through the heart. And the abnormality
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`can be manifest by irregular rhythms, by fast 09:38:24
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`rhythms, by slow rhythms. The abnormality can
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`manifest as normal heart rates.
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` And I think that's one of the things I --
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`I tried to -- I tried to clarify in my rebuttal
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`report. 09:38:38
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` Q. You understand, sir, that the judge in 09:38:38
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`our case has defined the term "arrhythmia" for use
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`in this investigation, correct?
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` A. That is correct.
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` Q. And you understand that it's very 09:38:49
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`important that during the course of the
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`investigation that you apply the court's
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`construction of the claim terms, including
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`arrhythmia?
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` A. That is correct. And that is what I have 09:39:00
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`done.
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` Q. And you understand that it is important
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`that the terms used in the claim language, as
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`interpreted by the court, are used consistently for
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`all purposes in this investigation? 09:39:15
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` A. That is my understanding.
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` Q. So you understand that you cannot
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`interpret a claim term differently for purposes of
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`infringement versus purposes of validity.
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` You understand that? 09:39:31
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` A. That -- that is my understanding. And
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`that's what I have done throughout both of my
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`reports.
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` My -- my -- just as a point of
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`clarification, my reports are with respect to 09:39:39
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`invalidity and they are rebuttal points to medical 09:39:42
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`concepts that -- that are -- appeared in
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`Dr. Jafari's report. I say nothing about
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`infringement. It's not something I know anything
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`really about. 09:39:58
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` Q. Understood.
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` But -- so you under- -- but my question
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`is simple, which is, you understand that claim
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`terms in this investigation should be interpreted
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`consistently for all purposes, whether it's for 09:40:08
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`prior art or for validity or infringement purposes.
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` Do you understand that?
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` A. Yes.
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` MS. REARDON: Object to form.
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` THE DEPONENT: Sorry. 09:40:18
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` You have to forgive me. This is my first
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`deposition. I'm trying to be as precise as --
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`as -- as possible.
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` Yes, I -- yes, I understand what you're
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`saying. I agree. 09:40:26
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` Q. (By Mr. Pak) Great.
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` So if I understand your testimony about
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`the definition of arrhythmia, is it fair that the
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`word "arrhythmia" could be used in academic
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`literature in ways that are broader than how the 09:40:49
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`court construed the term "arrhythmia" for the 09:40:52
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`purposes of this investigation?
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` M