UNITED STATES
`INTERNATIONAL TRADE COMMISSION
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`--------------------------------x
`In the Matter of
` Investigation No.
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`CERTAIN WEARABLE ELECTRONIC 337-TA-1266
`DEVICES WITH ECG FUNCTIONALITY AND
`COMPONENTS THEREOF
`--------------------------------x
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`OPEN/CLOSED SESSIONS
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`Pages:
`Place:
`Date:
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`828 through 1101
`Washington, D.C.
`March 31, 2022
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`HERITAGE REPORTING CORPORATION
`Official Reporters
`1220 L Street, N.W., Suite 206
`Washington, D.C. 20005
`(202) 628-4888
`contracts@hrccourtreporters.com
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`1
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`APPLE 1072
`Apple v. AliveCor
`IPR2021-00972
`
`
`INTERNATIONAL TRADE COMMISSION
`
`--------------------------------x
`In the Matter of
` Investigation No.
`
`CERTAIN WEARABLE ELECTRONIC 337-TA-1266
`DEVICES WITH ECG FUNCTIONALITY AND
`COMPONENTS THEREOF
`--------------------------------x
`
`OPEN/CLOSED SESSIONS
`
`Pages:
`Place:
`Date:
`
`828 through 1101
`Washington, D.C.
`March 31, 2022
`
`HERITAGE REPORTING CORPORATION
`Official Reporters
`1220 L Street, N.W., Suite 206
`Washington, D.C. 20005
`(202) 628-4888
`contracts@hrccourtreporters.com
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` 1 O P E N S E S S I O N
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` 3 COLLIN STULTZ, MD, PhD,
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` 4 having been first duly sworn and/or affirmed
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` 5 on his oath, was thereafter examined and testified as
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` 6 follows:
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` 7 THE WITNESS: I was muted. Yes, I do.
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` 8 JUDGE ELLIOT: Very well. Counsel, could you
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` 9 please note your appearances?
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` 10 MR. AMON: Yes, Your Honor. Michael Amon on
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` 11 behalf of Respondent.
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` 12 MR. HOLMES: Andrew Holmes on behalf of AliveCor.
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` 13 JUDGE ELLIOT: All right. So we are on the
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` 14 public record. Go ahead, Mr. Amon.
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` 15 MR. AMON: Thank you, Your Honor.
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` 16 DIRECT EXAMINATION
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` 17 BY MR. AMON:
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` 18 Q. Could you please introduce yourself to the Court?
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` 19 A. My name is Collin Stultz. I'm a cardiologist at
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` 20 the Massachusetts General Hospital and a professor at the
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` 21 Massachusetts Institute of Technology.
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` 22 Q. Dr. Stultz, did you prepare any slides to
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` 23 accompany your testimony today?
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` 24 A. Yes, I did.
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` 25 Q. Could we bring those up, please? And if we go to
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` 1 RDX-3.2, can you briefly summarize your educational
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` 2 background starting with college?
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` 3 A. Yes. My educational background is summarized on
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` 4 this slide. I went to Harvard College and got a bachelor's
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` 5 degree in mathematics and philosophy. Then went on to
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` 6 Harvard Medical School where I got my MD and also obtained a
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` 7 PhD in biophysics also from Harvard University. And then
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` 8 went on to my clinical training at the Brigham and Women's
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` 9 Hospital, first in internal medicine and subsequently in
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` 10 cardiology.
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` 11 Q. And how long -- sorry. If we go to RDX-3.3,
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` 12 where do you work today, sir?
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` 13 A. I work at the Massachusetts General Hospital and
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` 14 at MIT.
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` 15 Q. How long have you been at Mass General?
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` 16 A. I've been there for about five years.
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` 17 Q. What do you do at Mass General?
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` 18 A. I'm a staff cardiologist.
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` 19 Q. You also said that you're a professor at MIT?
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` 20 A. That is correct.
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` 21 Q. And what is your title at MIT?
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` 22 A. I'm an ENT and Robert H. Rubin Endowed Professor
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` 23 of Medical Engineering and Science and a professor of
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` 24 electrical engineering and computer science.
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` 25 Q. I apologize. I failed to ask, before you were a
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` 1 cardiologist at Mass General, did you practice cardiology
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` 2 someplace else?
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` 3 A. Yes, I did.
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` 4 Q. Where is that?
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` 5 A. I was in Veterans Affairs System at the West
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` 6 Roxbury V.A. Hospital.
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` 7 Q. How long were you a cardiologist at the Veterans
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` 8 Affairs Hospital in Roxbury?
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` 9 A. About 14, 15 years.
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` 10 Q. And so how long have you been a practicing
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` 11 cardiologist?
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` 12 A. Approximately 20 years, and, if you include the
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` 13 time in my fellowship training, it's been over 20 years I've
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` 14 been caring for patients with cardiovascular disease.
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` 15 Q. And returning to your position at MIT, what do
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` 16 you teach at MIT?
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` 17 A. So I've taught a panoplea of different classes,
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` 18 typically quantitative physiology where we model different
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` 19 physiologic systems using simple electrical circuits to
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` 20 relate the fundamental principles.
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` 21 And more recently I've taught a class that is an
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` 22 introduction to electrical engineering and computer science
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` 23 from a medical perspective. It's run a gamut of different
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` 24 topics.
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` 25 Q. How long have you been on the faculty at MIT?
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` 1 A. Approximately 18 years.
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` 2 Q. I believe you also said that you're on the
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` 3 faculty at Harvard?
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` 4 A. That's right. I'm a member in the Harvard-MIT
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` 5 Division of Health Sciences and Technology.
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` 6 Q. And what do you teach at Harvard?
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` 7 A. So I've given lectures in a lot of different
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` 8 classes: anatomy, cardiovascular, pathophysiology,
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` 9 biochemistry, and such.
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` 10 Q. And how long have you been on the faculty at
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` 11 Harvard?
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` 12 A. Also approximately 18 years.
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` 13 Q. If we go to RDX-3.4, are there any classes that
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` 14 you teach that are relevant to the subject matter in this
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` 15 case?
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` 16 A. Yes. So the class I alluded to previously, 6.03,
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` 17 Introduction to Electrical Engineering and Computer Science,
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` 18 again, this is a course that introduces students to
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` 19 fundamental principles in electrical engineering and
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` 20 computer science as they relate to the clinical domain.
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` 21 Q. And does that class include principles of ECG
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` 22 design and ECG sensors and data analysis?
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` 23 A. Yeah. And that is what is expressed in this
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` 24 slide. If you look in the upper right-hand corner, at the
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` 25 electrocardiogram circuit, that is a very simple,
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` 1 rudimentary device that students use to record their own
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` 2 electrocardiograms as part of laboratory exercises.
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` 3 And they also process their electrocardiograms to
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` 4 get different information. In particular, we do HRV
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` 5 calculations on these data.
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` 6 Q. If you go to RDX-3.5, do you also teach classes
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` 7 regarding the use and analysis of PPG signals and data?
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` 8 A. Yes, I do. So in this course we've had various
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` 9 iterations where we've looked at different signals.
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` 10 And this is from a previous iteration where
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` 11 students were also introduced to PPG, and we calculated --
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` 12 they calculated heart rate variability metrics again from
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` 13 these signals as well.
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` 14 Q. And how long have you been teaching these types
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` 15 of classes?
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` 16 A. So this course has been about seven years, I
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` 17 would say. But, again, before that I was teaching related
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` 18 coursework modeling the cardiovascular, respiratory systems
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` 19 using a variety of quantitative techniques.
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` 20 Q. Is machine learning part of the classes that you
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` 21 teach?
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` 22 A. Yes. Yes, it is.
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` 23 Q. More fundamentally, is machine learning a
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` 24 professional focus of yours?
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` 25 A. I'm sorry. You trailed off at the end. I didn't
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` 1 hear the last comment.
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` 2 Q. I apologize, Dr. Stultz. Is machine learning a
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` 3 professional focus of yours?
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` 4 A. Absolutely. So I've led a research group since
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` 5 I've been at MIT, and our very significant, if not our
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` 6 complete focus, over the last few years, in particular over
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` 7 the last ten years, has been on the development and
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` 8 application of machine learning algorithms for clinical
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` 9 applications with a special focus on the cardiovascular
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` 10 space. And we leverage analyses of many different types of
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` 11 signals, including, in particular, ECG signals.
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` 12 Q. If we go to RDX-3.6, can you describe any
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` 13 involvement you've had in the design and development of
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` 14 wearable devices that include physiological sensors and/or
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` 15 machine learning?
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` 16 A. Yes. So this encapsulates a lot of my experience
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` 17 outside of the classroom and outside of the hospital in this
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` 18 space. So some of these companies were started by
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` 19 colleagues and students of mine. In particular, Bloomertech
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` 20 is a company started by a former student of mine, and that
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` 21 company aspires to design ECG electrodes in bras to get
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` 22 information, electrocardiographic information, from women to
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` 23 help with cardiac risk stratification.
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` 24 Unlearn AI is a machine learning company, more so
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` 25 in the Alzheimer's space, but that was started by a former
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` 1 student of mine as well.
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` 2 And Empallo is an MIT spinoff that I was asked to
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` 3 sit on the Scientific Advisory Board Committee, and that
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` 4 looks at congestive heart failure, developing AI and machine
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` 5 learning methods for those patients.
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` 6 Q. Dr. Stultz, have you and do you publish and
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` 7 lecture in the area of physiological sensors and machine
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` 8 learning?
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` 9 A. Absolutely. We have published extensively in
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` 10 this space and I've given many talks in this area.
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` 11 Q. If we go to RDX-3.7, are there any awards that
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` 12 you've received for your work in the field?
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` 13 A. So I think throughout my professional career I've
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` 14 been humbled and honored to have a number of awards for the
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` 15 work that's done in my group, and some of those are outlined
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` 16 here.
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` 17 Q. What is the AIMBE Fellow Award that you list
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` 18 there first on this slide?
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` 19 A. That's the American Institute of Medical and
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` 20 Biomedical Engineers, and being elected to the Fellowship is
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` 21 considered to belong to the top 2 percent of biomedical
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` 22 engineers in the country.
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` 23 MR. AMON: Your Honor, we would offer Dr. Collin
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` 24 Stultz as an expert in the field of cardiology, the design
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` 25 of physiological sensors, the interpretation of
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` 1 physiological signals and machine learning for physiological
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` 2 sensors and measurements.
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` 3 JUDGE ELLIOT: Very well.
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` 4 Q. Now, Dr. Stultz, have you ever served as an
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` 5 expert before?
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` 6 A. I have never. This is the first time I have ever
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` 7 given testimony in a courtroom.
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` 8 Q. And why were you interested in serving as an
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` 9 expert in this case?
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` 10 A. So I not infrequently get email requests to be
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` 11 involved in some way with litigation, and up until today I
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` 12 have been -- I have ignored all such requests. I got
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` 13 involved here because a colleague -- a senior colleague of
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` 14 mine who I respect a great deal, I think gave my name to
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` 15 counsel who then contacted me, and at least that allowed me
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` 16 to begin the discussion.
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` 17 And then I was sent the three patents in question
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` 18 to look at. And what struck me about the claims in these
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` 19 particular patents was how general they are and how they
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` 20 cover much of what clinicians do, what they learn in medical
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` 21 school, and much of what they do in the care of patients
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` 22 with a variety of different disorders.
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` 23 And, lastly, my group develops for stratification
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` 24 methods using ECG and other technology, and I thought it
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` 25 would be useful to learn about the patent litigation
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` 1 process.
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` 2 Q. Dr. Stultz, as part of your work, did you come to
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` 3 learn the term "person of ordinary skill in the art"?
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` 4 A. Yes, I did.
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` 5 Q. If we go to RDX-3.8, what is your understanding
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` 6 of how the Court defined a person of ordinary skill in the
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` 7 art for this case?
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` 8 A. So my understanding is as depicted on this slide.
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` 9 It encompasses a person who has a Bachelor of Science degree
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` 10 in engineering or related discipline, at least two years of
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` 11 relevant work experience, or an individual who has a medical
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` 12 degree and five years of such work, and, lastly, that
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` 13 relevant experience and education could substitute for one
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` 14 another.
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` 15 Q. Do you believe that you qualify as a POSA under
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` 16 the Court's definition?
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` 17 A. I believe that I do.
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` 18 Q. And do you qualify actually under both prongs of
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` 19 the Court's definition?
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` 20 A. I have a bachelor's degree in mathematics, which
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` 21 I consider to be a related discipline. I've worked two
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` 22 years in the space. I have a medical degree and have worked
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` 23 five years. But the last proviso, related experience can
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` 24 substitute for education, I have a PhD in biophysics.
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` 25 Q. Now, to be fair, do you have more experience than
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` 1 the Court's definition requires?
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` 2 A. I believe that my experience is greater than what
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` 3 is described here.
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` 4 Q. Then how are you able to understand and analyze
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` 5 how a person of ordinary skill would understand the relevant
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` 6 concepts at issue?
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` 7 A. One of the best parts of my job is the
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` 8 interactions I have had mentoring trainees and students and
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` 9 interacting with them. And I have, in that regard, I have
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` 10 trained scholars at various levels of their career from the
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` 11 undergraduate student to the graduate student to people who
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` 12 work in the industry. And I try to leverage those
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` 13 experiences to inform my opinions here.
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` 14 Q. Dr. Stultz, what did Apple retain you to do in
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` 15 this case?
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` 16 A. So there were two primary tasks that I was
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` 17 handed. The first being to opine on whether the three
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` 18 patents at issue are valid, and the second being to respond
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` 19 to statements from Dr. Jafari of a medical nature with
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` 20 respect to whether I agreed with the content.
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` 21 Q. If we go to RDX-3.9, we'll get to the details of
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` 22 your opinions later, but can you summarize what opinions
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` 23 you've reached in this investigation?
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` 24 A. It is my view that Dr. Jafari in his statements,
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` 25 I respectfully disagree that, indeed, I think he misstates
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` 1 certain fundamental concepts in medicine and cardiology.
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` 2 With respect to the patents at issue, it is my
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` 3 view that they are directed to patent ineligible subject
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` 4 matter, primarily because they capture what is the standard
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` 5 of care and what medical students learn in medical school,
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` 6 and, lastly, knowing what the state of the art at the time,
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` 7 it is my view that a POSITA would have considered those
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` 8 three -- the claims, the specific claims outlined in those
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` 9 patents as being obvious.
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` 10 Q. Dr. Stultz, going to RDX-3.10, to set the stage,
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` 11 can you describe generally how blood throws through the
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` 12 heart?
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` 13 A. So this is a very high-level description of blood
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` 14 flow through the heart, and I think it helps to orient us
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` 15 for the subsequent discussion.
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` 16 So the heart, at a very high level, is a pump.
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` 17 It takes blood from one area and pumps it to another.
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` 18 Everybody intrinsically has two hearts. There is a right
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` 19 heart and a left heart.
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` 20 The right heart takes blood that is relatively
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` 21 devoid of oxygen, pumps it to the lungs. The blood picks up
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` 22 oxygen in the lungs, returns it to the left heart, and the
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` 23 left heart pumps it to the rest of the body.
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` 24 And there are four chambers that are -- that take
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` 25 part in this process that are listed here -- right atrium,
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` 1 right ventricle in the right heart; left atrium, left
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` 2 ventricle in the left heart.
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` 3 And the last thing that is relevant is that the
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` 4 flow of blood through this circuit is not passive. It
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` 5 requires active contraction of each of these four chambers
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` 6 to ensure the blood is propelled in an orderly way through
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` 7 this circuit.
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` 8 Q. If we go to RDX-3.11, what causes that pumping
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` 9 that you just described?
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` 10 A. So on the left-hand side, this is a depiction of
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` 11 the contraction, heart contractions, and the point that I
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` 12 want to make here is that there is this yellow network which
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` 13 represents, in part, the electrical system of the heart.
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` 14 And it's the transmission of this electrical energy through
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` 15 the heart that actually causes contraction. It's electrical
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` 16 flow that precipitates contraction or catalyzes contraction
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` 17 more precisely.
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` 18 And on the right-hand side is how we observe this
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` 19 electrical flow, and that's with a surface
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` 20 electrocardiogram. And this figure on the right is just an
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` 21 electrocardiographic image that tells us about the
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` 22 electrical flow through the heart.
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` 23 Q. If we go to RDX-3.12, that process you just
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` 24 described, does that have a shorthand term that doctors
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` 25 refer to it as?
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` 1 A. So movement of electricity through the heart is
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` 2 commonly referred to as depolarization. And the reason for
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` 3 that is that each cardiac cell, each cardiac myocyte is
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` 4 normally polarized with respect to ions. So there are some
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` 5 ions that like to be on the outside of the cell and some
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` 6 ions that like to be on the inside of the cell.
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` 7 And when depolarization happens, you lose this
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` 8 polarity. The ions on the outside move to the inside and
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` 9 vice versa. And this depolarization process is responsible
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` 10 for the current flow.
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` 11 And the point I'm trying to make here is that
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` 12 each of these events, depolarization or current flow through
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` 13 different chambers, have a characteristic shape in the
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` 14 electrocardiogram.
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` 15 So on the right-hand side of this figure -- can
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` 16 you see my cursor, if I move it here, no?
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` 17 Q. I don't believe we can.
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` 18 A. I'm sorry. So the flow of electricity, this
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` 19 current flow through the right atria corresponds to this
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` 20 P wave, and that's in a portion of the graph labeled atrial
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` 21 depolarization, atrial depolarization and subsequent
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` 22 contraction corresponds to the P wave.
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` 23 Depolarization of the ventricles, movement of
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` 24 this electricity through ventricles correspond to the QRS.
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` 25 So if you look at the bottom row, the blue heart,
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` 1 blue ventricles, labeled ventricles depolarize, and you see
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` 2 right next to that is a subsequent -- is a corresponding
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` 3 electrocardiogram, there's a P wave, because the atria have
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` 4 already depolarized. And this QRS complex that corresponds
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` 5 to the ventricles -- and the system resets so that you can
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` 6 have another contraction, and that's the latter part in the
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` 7 lower right-hand side of the figure.
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` 8 Q. If we go to RDX-3.13, can that depolarization
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` 9 process be abnormal?
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` 10 A. Yes, it can. So I've depicted here four
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` 11 different examples of different rhythm. So the top rhythm
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` 12 called normal sinus rhythm, this is normal. There are a
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` 13 series of beats and you can -- you can equate loosely or
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` 14 largely each of these peaks, the R wave with a different
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` 15 beat. Each R wave has a P wave before it and a T wave
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` 16 after.
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` 17 Now instances in which the conduction is abnormal
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` 18 are listed below. In the second row we have sinus
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` 19 tachycardia. And in that instance, whereas, once the
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` 20 conduction starts, its spread is normal, the frequency of
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` 21 this -- in which it starts is very fast. So the firing of
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` 22 the current is -- has a very high frequency, and,
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` 23 consequently, the heart rate is faster, sinus tachycardia.
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` 24 And then there are other examples that lead to
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` 25 irregular rhythms, atrial fibrillation, which is very
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` 1 apropos for this discussion, but it's not the only one that
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` 2 yields an irregular rhythm. We have atrial flutter with
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` 3 variable block being another rhythm that does so.
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` 4 Q. If we go to RDX-3.14, what is the definition of
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` 5 arrhythmia you use for your analysis in this case?
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` 6 A. So what I have here is my understanding of the
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` 7 Court's construction of what an arrhythmia is. It is a
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` 8 cardiac condition in which the electrical activity of the
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` 9 heart is irregular or is faster or slower than normal.
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` 10 Q. As a practicing cardiologist, what does cardiac
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` 11 condition mean in that definition to you?
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` 12 A. So using the plain language before me, a cardiac
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` 13 condition is a condition of the heart or otherwise a disease
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` 14 of the heart.
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` 15 Q. If we go to RDX-3.15, are there depolarization
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` 16 abnormalities that are cardiac conditions?
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` 17 A. Yes, there are, and I've depicted two here.
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` 18 So in the top row on the left-hand side there's a
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` 19 disorder I've labeled or that is labeled heart with dilated
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` 20 cardiomyopathy. In this disorder, the structure of the
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` 21 heart is very abnormal. The chambers are enlarged, the
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` 22 pressures in the heart are elevated, and this is associated
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` 23 with atrial fibrillation that I've depicted on the
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` 24 right-hand side.
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` 25 Another example is myocardial infarction. So
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` 1 this is typically known as a heart attack when there's a
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` 2 blockage in the vessels that feed the heart and the heart --
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` 3 the portion of the heart muscle dies. And that can induce a
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` 4 variety of different arrhythmias, on the right-hand side,
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` 5 another burst of ventricular tachycardia. The common theme
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` 6 being that both of these are primary insults to the heart.
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` 7 Q. RDX-3.16, are there situations where the
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` 8 electrical activity of the heart is fast or irregular, but
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` 9 it's not due to a cardiac condition?
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` 10 A. Yes, there are, and I've depicted three here.
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` 11 So the most common being exercise. So when you
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` 12 exercise, the muscles, the organs, the brain need more
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` 13 blood, and so the heart has to beat faster to compensate,
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` 14 and that results in a sinus tachycardia.
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` 15 In an infected state, which is the middle slide,
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` 16 patients can have fever and/or the blood vessels throughout
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` 17 the body become dilated, and the heart has to beat faster to
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` 18 keep up to maintain an adequate blood pressure.
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` 19 And in the latter case some medications, some
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` 20 antihistamines or even too much coffee, can give you extra
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` 21 beats, called ventricular premature beats or ventricular
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` 22 premature contractions, and this would be manifested as an
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` 23 irregular rhythm.
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` 24 Q. Dr. Stultz, did you hear AliveCor's expert
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` 25 Dr. Jafari's testimony in this hearing on Tuesday?
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`Heritage Reporting Corporation
`(202) 628-4888
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`17
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` 1071
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` 1 A. Yes, I did.
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` 2 Q. Did you hear his definition of tachycardia?
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` 3 A. Yes, I did.
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` 4 Q. Did you hear Dr. Jafari reference the Mayo
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` 5 Clinic's definition of tachycardia?
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` 6 A. I did.
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` 7 Q. If we go to RDX-3.17, for the record, Your Honor,
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` 8 this is highlighting Exhibit RX-764.
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` 9 How does the Mayo Clinic define tachycardia?
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` 10 A. So the Mayo Clinic's definition of tachycardia
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` 11 agrees with the one I previously provided.
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` 12 If you look under causes, tachycardia is an
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` 13 increased heart rate for any reason. And the precise cutoff
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` 14 there is 100 beats per minute. There's a listing of things
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` 15 that can cause tachycardia: fever, alcohol use, caffeine and
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` 16 such.
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` 17 Q. Do you agree with that definition of tachycardia,
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` 18 Dr. Stultz?
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` 19 A. I do. Tachycardia is a heart rate above 100
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` 20 beats per minute irrespective of the cause.
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` 21 Q. Did you also listen to Dr. Picard's testimony
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` 22 earlier today?
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` 23 A. I did.
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` 24 Q. And did you hear the part where Mr. Winston
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` 25 pointed Dr. Picard to the American Heart Association link on
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`Heritage Reporting Corporation
`(202) 628-488
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