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
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`OPEN/CLOSED SESSIONS
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`Pages:
`Place:
`Date:
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`1102 through 1375
`Washington, D.C.
`April 1, 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 1073
`Apple v. AliveCor
`IPR2021-00972
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`INTERNATIONAL TRADE COMMISSION
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`--------------------------------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:
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`1102 through 1375
`Washington, D.C.
`April 1, 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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`APPLE 1073
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` 1 analysis this morning.
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` 2 JUDGE ELLIOT: That's right. Thank you. Now I
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` 3 remember. Very good. All right.
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` 4 We're on the public record. And I'm waiting for
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` 5 Dr. Stultz.
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` 6 Good morning Dr. Stultz. Let me remind you
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` 7 you're still under oath.
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` 8 COLLIN STULTZ,
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` 9 having been previously duly sworn and/or
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` 10 affirmed on his oath, was thereafter examined and testified
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` 11 further as follows:
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` 12 DIRECT EXAMINATION (resumed)
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` 13 BY MR. AMON:
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` 14 Q. Good morning, Dr. Stultz. I'd like to now start
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` 15 with your obviousness analysis.
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` 16 If we could bring up RDX-3.39.
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` 17 What framework did you use in analyzing your --
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` 18 whether the Asserted Patents are invalid for obviousness?
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` 19 A. So the framework I use is as illustrated on this
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` 20 slide. There were four steps in the process.
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` 21 First, to determine the scope and content of the
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` 22 prior art, and to understand differences between that art
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` 23 and the patent claim, and all of this is done within the
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` 24 context of the person of ordinary skill in the art at the
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` 25 time, and then, lastly, there were specific secondary
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` 1 considerations presented, is my understanding, by AliveCor,
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` 2 and the question there is whether those considerations
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` 3 affected my view.
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` 4 Q. Dr. Stultz, what is Apple's burden in proving
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` 5 that the Asserted Patents are invalid?
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` 6 A. It is my understanding that it must be shown by
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` 7 clear and convincing evidence.
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` 8 Q. And just to backtrack for one second, is it your
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` 9 understanding that Apple's burden is clear and convincing
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` 10 for the patent-ineligible subject matter as well?
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` 11 A. That is my understanding.
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` 12 Q. If we go to RDX-3.40. What is this timeline,
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` 13 Dr. Stultz?
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` 14 A. So this timeline includes the relevant dates for
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` 15 the patents in question, and it also outlines, briefly,
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` 16 papers that represent the state of the art at the time.
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` 17 So just -- I'm sorry to interrupt, but just to
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` 18 expand upon that a little bit.
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` 19 When I began this process, what I did was sit in
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` 20 front of my computer and do a literature search setting the
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` 21 time frame to 2013, which is the earliest date for the '499
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` 22 and '731 patents, and then gathered the papers, and I think
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` 23 there were maybe 50 to a hundred papers that were -- and
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` 24 then reviewed those data.
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` 25 And I think what was known at the time and the
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` 1 work going on at the time is well encapsulated by these four
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` 2 references in green.
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` 3 MR. AMON: For the record, Your Honor, the
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` 4 references that Dr. Stultz is referring to are RX-560,
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` 5 RX-562, RX-554, and RX-563.
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` 6 Q. Dr. Stultz, if we go to RDX-3.41, what is on this
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` 7 slide here?
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` 8 A. So this are the three primary references that I
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` 9 rely on for my obviousness argument. There is AMON 2004 and
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` 10 then there are two additional references, Kotzin, which was
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` 11 published in 2004, and Almen published in 2008.
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` 12 Q. Let me pause there for a second.
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` 13 MR. AMON: Your Honor, I think there was a little
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` 14 feedback. I don't know if you heard that.
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` 15 (Clarification by reporter.)
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` 16 JUDGE ELLIOT: I'm sorry. I was muted. I was
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` 17 actually trying to say something and I was muted. I don't
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` 18 know who that was, but, if you're not on video, please mute
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` 19 yourself.
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` 20 MR. AMON: For the record, Your Honor, the AMON
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` 21 reference is RX-419, the Almen reference is RX-400, and the
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` 22 Kotzin reference is 401.
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` 23 What is the date of the AMON reference?
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` 24 A. The AMON reference is December 2004.
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` 25 Q. What is the date of the Almen reference?
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` 1 A. That's also in December of 2008.
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` 2 Q. And, finally, what is the date of the Kotzin
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` 3 reference?
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` 4 A. That was February 2004.
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` 5 Q. If we go to RDX-3.42. What does the AMON
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` 6 reference disclose?
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` 7 A. So Amon describes a wearable medical monitoring
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` 8 alert system, particularly targeting high-risk cardiac
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` 9 respiratory patients.
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` 10 The interesting thing here is that this is a
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` 11 wrist-worn device that encompasses multiple sensors, sensors
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` 12 including SpO2, blood pressure, and ECG.
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` 13 Q. Just so that the record is clear, does an SpO2
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` 14 sensor include a PPG?
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` 15 A. That's right. So SpO2 technology is based on PPG
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` 16 technology. Indeed, PPG gives you changes in the blood
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` 17 volume in a particular vascular bed, so it sort of gives you
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` 18 an estimate of the pulse rate. And the SpO2 builds on that
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` 19 technology by incorporating different light sensors that
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` 20 allow you to estimate the oxygenation in the corresponding
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` 21 blood.
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` 22 Q. If we go to RDX-3.43, was the AMON reference
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` 23 cited by others in the field before May of 2015?
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` 24 A. So in my literature search, I found one paper
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` 25 that was listed on the left that specifically references
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` 1 AMON. And in this paper they talk about a smartphone app
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` 2 that combines information from multiple sensors to aid with
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` 3 clinical restratisfication and decision-making.
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` 4 And they say specifically their solution is
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` 5 similar to AMON and analyses and -- and other things,
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` 6 analysis of ECG on a local device.
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` 7 The second reference is on the right, and in this
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` 8 reference they referred to the AMON prototype as being
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` 9 innovative. I think the only point here is to say that AMON
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` 10 published in 2004 was noted by others in a way that it
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` 11 suggests, at least from my read of these data, that it was
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` 12 inspiring.
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` 13 MR. AMON: And for the record, Your Honor, the
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` 14 additional reference cited here is RX-420.
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` 15 Q. If we go to RDX-3.44, what does the Almen
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` 16 reference disclose?
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` 17 A. So Almen, A-L-M-E-N, also refers to a wrist-worn
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` 18 device. It can be an armband as well. And the particular
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` 19 thing about Almen is that it focuses on optical sensing to
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` 20 measure heart rate variability for a variety of different --
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` 21 I think the term they use is cardiac maladies.
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` 22 Q. And if we go to RDX-3.45, what does the Kotzin
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` 23 reference disclose?
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` 24 A. So Kotzin discloses a portable communication
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` 25 device that can have one or more sensors. And the thing
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` 1 here is it describes a system for communication between the
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` 2 sensors and for relaying information from the sensors to the
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` 3 user.
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` 4 Q. So let's go to RDX-3.46. We're going to start
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` 5 your obviousness analysis with the '941 patent.
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` 6 Can you remind the Court the priority date for
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` 7 the '941 patent, please?
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` 8 A. That was in May 2015.
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` 9 Q. Now looking at the limitations of claim 12 of the
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` 10 '941, do you understand that there are certain limitations
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` 11 that AliveCor does not dispute were disclosed by the AMON
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` 12 reference?
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` 13 A. That's my understanding.
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` 14 Q. Which are those limitations?
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` 15 A. Those are the limitations listed in A, B, C, and
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` 16 D on this slide.
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` 17 Q. In your opinion, Dr. Stultz, does the AMON
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` 18 reference disclose limitations A, B, C, and D of claim 12 of
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` 19 the '941?
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` 20 A. Yes, it does.
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` 21 Q. So what is the first limitation that AliveCor
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` 22 contests from claim 12 of the '941 as we can see on this
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` 23 slide?
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` 24 A. It's the preamble, a smart watch comprising.
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` 25 Q. If we go to RDX-3.47, does the AMON reference
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` 1 disclose a smart watch?
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` 2 A. So, it's interesting, because the reference
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` 3 explicitly discloses a wrist-worn device that is able to
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` 4 show time and compares it to other computerized watches, and
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` 5 that includes these different sensors. At the very least
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` 6 it's a prototype for a smart watch. And, in my view, in
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` 7 2004 it certainly would be considered a smart watch.
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` 8 Q. If we go to RDX-3.48, does AliveCor next contest
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` 9 limitation (e) of claim 12 of the '941?
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` 10 A. That is my understanding.
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` 11 Q. And it's a lengthy limitation, so let's look at
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` 12 it in your analysis, if we go to RDX-3.49.
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` 13 In your opinion does the AMON reference disclose
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` 14 a non-transitory computer-readable storage medium encoded
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` 15 with a computer program including instructions executable by
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` 16 the processor?
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` 17 A. In my view it does. Non-transitory
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` 18 computer-readable storage medium is essentially a mechanism
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` 19 for short-term storage. And AMON specifically discloses, if
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` 20 you look on the left-hand side of this slide, in this
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` 21 diagram, flash memory, it says it has four megabytes of
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` 22 flash memory, additional 136 of on-chip additional memory,
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` 23 SRAM, for program and data storage.
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` 24 Q. And does it include -- does the AMON reference
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` 25 disclose instructions?
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` 1 A. Oh, yes, it does. And the SRAM chip is
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` 2 specifically for programming data storage.
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` 3 Q. If we go to RDX-3.50, does the AMON reference
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` 4 disclose determining if a discordance is present between the
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` 5 activity level value of the user and the heart rate
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` 6 parameter of the user?
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` 7 A. So this is quite interesting. So Amon tries to
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` 8 identify high-risk zones given observations of patient data.
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` 9 So the observations include the pulse rate, and
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` 10 it tries to determine a high-risk zone based on settings.
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` 11 And that is illustrated here in table 1.
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` 12 The key point here is that the settings are
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` 13 determined by the activity level, and that we see in the
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` 14 text on the left-hand side; namely, AMON is capable of
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` 15 detecting the level of user activity and correlating it with
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` 16 vital signs. Moreover, it specifies pulse limits are set
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` 17 according to the activity level, walking, running or
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` 18 resting.
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` 19 So the high-risk areas are -- signify when the
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` 20 parameters are inconsistent with the activity level.
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` 21 Q. In your opinion, does that disclose a
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` 22 discordance?
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` 23 A. Yes, it is, because the settings -- it's
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` 24 particularly high risk because it's inconsistent with that
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` 25 activity level.
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` 1 Q. If we go to RDX-3.51, does the AMON reference
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` 2 disclose that based on the presence of a discordance it
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` 3 indicates possible arrhythmia?
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` 4 A. Right. So I think using the terminology that --
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` 5 of arrhythmia given in the Court, the things that are --
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` 6 that can -- faster or slower than normal can potentially be
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` 7 arrhythmias.
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` 8 In this high-risk zone, and if you look here in
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` 9 table 1, and the normal values are at rest, so a pulse rate
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` 10 of 121 to 180 would have been considered to be a high risk,
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` 11 abnormal, and that fits within the Court's definition of
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` 12 an -- at least a potential arrhythmia.
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` 13 Q. To the extent that the AMON reference does not
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` 14 expressly disclose indicating the arrhythmia, would it have
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` 15 been obvious to a person of ordinary skill that they could
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` 16 take -- use the information from the AMON reference, modify
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` 17 it, and determine a discordance -- an arrhythmia based on a
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` 18 discordance? Excuse me.
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` 19 A. I think using the definition, that's right, of an
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` 20 arrhythmia, certainly events when the heart rate is higher.
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` 21 In 2013, I think individuals first in this space would have
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` 22 been working closely or at least have interactions with
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` 23 health care professionals, and I think these concepts would
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` 24 not have been alien to such an individual.
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` 25 Q. Would the same have been true by May of 2015?
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` 1 A. That is my view.
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` 2 Q. If we go to RDX-3.52, does the AMON reference
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` 3 disclose receiving electric signals of the user from the ECG
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` 4 sensor to confirm the presence of the arrhythmia?
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` 5 A. Yes, it does. So if you look at the middle, the
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` 6 verbiage in the middle portion of this slide, it says,
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` 7 parameter out of range, remeasurement is performed, if the
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` 8 outcome is the same as before, the user is informed
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` 9 additional measurements are required, but one of the
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` 10 measurements can be the ECG.
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` 11 Q. If we go to RDX-3.53, in your opinion does the
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` 12 Kotzin reference also disclose receiving electric signals of
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` 13 the ECG to confirm the presence of the arrhythmia?
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` 14 A. Yeah, I think that's the case. So Kotzin talks
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` 15 about different sensors and characteristics. I think in the
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` 16 actual reference they say sensors, they mean biosensors.
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` 17 And communication between these sensors, if one of them is
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` 18 determined to be unfavorable, meaning outside of the range
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` 19 of some threshold, then an alert is sent to the user to
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` 20 perform a specific action. That action can be measuring a
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` 21 different characteristic, i.e., from a different -- from a
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` 22 different sensor.
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` 23 Q. Dr. Stultz, did you hear Dr. Picard's testimony
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` 24 regarding how a person of ordinary skill would have
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` 25 understood what it means to confirm the presence of the
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` 1 arrhythmia?
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` 2 A. Yes, I did.
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` 3 Q. Did you also hear Dr. Jafari's testimony about
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` 4 what it means to confirm the presence of the arrhythmia?
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` 5 A. Yes, I did.
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` 6 Q. Do you agree with how Dr. Picard understands that
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` 7 confirming limitation of claim 12 of the '941?
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` 8 A. I do.
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` 9 Q. If the Court accepts Dr. Jafari's understanding
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` 10 of the plain and ordinary meaning of confirming, does that
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` 11 impact your invalidity analysis?
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` 12 A. So I think two points are relevant here. One,
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` 13 the AMON reference describes both intermittent ECG
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` 14 measurements in addition to continuous ECG measurements. So
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` 15 I think both are encapsulated in this reference.
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` 16 The other point is the definition supplied by
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` 17 Dr. Jafari, with all due respect, is a little unclear to me.
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` 18 So that has to be -- that proviso has to be attached to my
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` 19 response.
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` 20 Q. Does the AMON reference disclose simultaneous
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` 21 measurements between PPG and ECG, in your opinion?
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` 22 A. I'm sorry. Can you repeat the question?
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` 23 Q. Sure. In your opinion, does the AMON reference
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` 24 disclose simultaneous measurements of PPG and ECG data?
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` 25 A. Yes, it does. It specifically discloses two
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` 1 scenarios where PPG and ECG can be measured continuously and
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` 2 simultaneously. It even says that this is done, at least I
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` 3 think, three times throughout the day. It also states that
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` 4 some of these measurements, including the ECG measurements,
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` 5 can be done intermittently.
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` 6 Q. RDX-3.54, in your opinion does the AMON reference
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` 7 alone or in combination with Kotzin disclose all the
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` 8 requirements of claim 12?
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` 9 A. Yes, it does.
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` 10 Q. So if we go to RDX-3.55, and start looking at the
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` 11 dependent claims, what does claim 13 require in addition to
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` 12 claim 12?
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` 13 A. So claim 13 recites, the smart watch or wristlet
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` 14 according to claim 12, wherein the heart rate parameter
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` 15 comprises an indication of a heart rate variability and
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` 16 wherein the arrhythmia is atrial fibrillation.
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` 17 Q. And if we go to RDX-3.56, in your opinion does
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` 18 the AMON reference render calculating HRV obvious?
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` 19 A. Yes, it does. AMON specifically discloses the
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` 20 measurement of R-R distances, which really is equivalent to
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` 21 the instantaneous heart rate. And I think we've heard
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` 22 before in this -- in the last few days the R-R distances and
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` 23 how they are calculated from the ECG.
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` 24 So it -- I mean, in 2013 and 2015 were relevant
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` 25 for this particular patent. It would have been a knee-jerk
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` 1 reaction, I think, for persons skilled in the art to see R-R
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` 2 distances and to think about heart rate variability
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` 3 calculations.
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` 4 Q. Dr. Stultz, do you understand that the '941 is
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` 5 talking about calculating HRV from the PPG signal?
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` 6 A. That is my understanding.
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` 7 Q. And, in your opinion, would a person of ordinary
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` 8 skill in May of 2015 have found it obvious to modify the
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` 9 AMON reference to calculate R-R from the PPG data?
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` 10 A. Yes, I think that's true. There's scholarship
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` 11 that speaks to this. There was works known beforehand that
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` 12 HRV could be calculated from the PPG. There have been works
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` 13 comparing PPG or R-R distances versus ECG. So, yes, I think
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` 14 it would have been obvious.
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` 15 Q. And if we go to RDX-3.57, did we see this slide
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` 16 during Dr. Jafari's presentation?
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` 17 A. It's my recollection that this was -- Dr. Jafari
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` 18 showed this slide during his presentation.
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` 19 Q. And what did Dr. Jafari explain using this slide?
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` 20 A. So here on this slide is, on the right-hand side,
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` 21 this is a waveform arising from a PPG, PPG signal. And the
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` 22 distance between the peaks are labeled as R-R intervals.
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` 23 And I agree with Dr. Jafari in this sense that,
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` 24 although R-R intervals, specifically the term refers to R
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` 25 waves within the electrocardiogram, that individuals skilled
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` 1 in the art at the time and now thought about calculating or
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` 2 would have considered calculating such interval lengths from
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` 3 the PPG as representative of R-R intervals.
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` 4 Q. Was this concept known in May of 2015?
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` 5 A. Yes, it was.
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` 6 Q. Was this concept known in December of 2013?
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` 7 A. In my view it was, yes.
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` 8 Q. And based on your training and education, was
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` 9 this concept known in 2004 when the AMON reference
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` 10 published?
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` 11 A. I think that this work was around, that's
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` 12 correct. Certainly most of the published work in this
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` 13 happened a little after 2004, at least the papers that I can
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` 14 recall, but certainly by 2013 and by 2015 this was
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` 15 well-known.
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` 16 Q. If we go to RDX-3.58, would the AMON reference
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` 17 have rendered obvious the arrhythmia being atrial
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` 18 fibrillation?
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` 19 A. So I think, again, the key operative term here is
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` 20 to a person skilled in the art. Again, someone who is
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` 21 working in this area. And the concept of recognizing a
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` 22 heart rate that is elevated, resting -- in the resting
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` 23 state, as suggesting arrhythmia is, I think is -- would have
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` 24 been known.
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` 25 A case in point, in the '941 patent there is an
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` 1 example given, I think it's from a tracing, that's what that
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` 2 0302 refers to, that's my recollection, where the heart rate
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` 3 rapidly increases, and that also being consistent with
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` 4 atrial fibrillation. That's really shown as an example to
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` 5 illustrate the point.
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` 6 Q. If we go to RDX-3.59, to the extent that the AMON
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` 7 reference does not disclose HRV or atrial fibrillation, did
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` 8 Almen disclose those additional requirements of claim 13?
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` 9 A. Yes, it did. So Almen, again, specifically
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` 10 recites a wrist-worn device with an optical sensor, and
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` 11 central to this is the calculation of heart rate variability
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` 12 from the optical sensor data, from the PPG data. And this
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` 13 is, again, I think for lots of things that, if memory --
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` 14 called cardiac maladies. Actually, the precise term here
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` 15 that's used the heart maladies, and they list a few, of
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` 16 which atrial fibrillation is one of them.
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` 17 Q. If we go to RDX-3.60, what does claim 16 add to
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` 18 claim 12?
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` 19 A. So claim 16 adds a smart watch or wristlet
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` 20 according to claim 12, wherein indicating to the user
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` 21 further comprises instructing the user to record an ECG
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` 22 using the ECG sensor.
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` 23 Q. If we go to RDX-3.61, does AMON disclose this
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` 24 additional limitation of claim 16?
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` 25 A. Yes, in my view it does. It mentions
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` 1 specifically that when a parameter is out of range, the user
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` 2 is informed to take additional measurements where one of
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` 3 those measurements can be an ECG. And, moreover, the
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` 4 patient is informed as to their own status and that of the
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` 5 device.
`
` 6 Q. If we go to RDX-3.62, do you understand whether
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` 7 AliveCor is disputing that AMON discloses the additional
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` 8 limitation of claim 18?
`
` 9 A. It is my understanding that they are not.
`
` 10 Q. And in your opinion does AMON disclose the
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` 11 additional limitation of claim 18?
`
` 12 A. Yes, it does.
`
` 13 Q. What does claim 19 add to claim 18?
`
` 14 A. So claim 19 adds, wherein the heart rate
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` 15 parameter is a heart rate variability value wherein the
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` 16 heart rate variability value is derived from the PPG signal.
`
` 17 Q. If we go to RDX-3.63, does AMON -- does the AMON
`
` 18 reference disclose the additional limitation of claim 19 in
`
` 19 your opinion?
`
` 20 A. Yes, it does. Again, it explicitly describes
`
` 21 calculating R-R distances, and heart rate variability being
`
` 22 calculated from R-R distances was well described at the
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` 23 time. Workers and individuals in this area thought about
`
` 24 these things, not quite synonymously, but certainly one was
`
` 25 a knee-jerk reaction for the other concept.
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`
`
`
`
`
`Heritage Reporting Corporation
`(202) 628-4888
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`17
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`
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` 1128
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`
` 1 Q. In May of 2013 would it have been obvious to
`
` 2 modify the AMON reference to use PPG data to derive HRV?
`
` 3 A. In my view, yes.
`
` 4 Q. If we go to RDX-3.64, to the extent AMON doesn't
`
` 5 disclose this, does Almen disclose calculating HRV from the
`
` 6 PPG signal?
`
` 7 A. So, as we've already discussed, a purpose of the
`
` 8 Almen, A-L-M-E-N reference, is to calculate HRV from optical
`
` 9 sensors, so yes.
`
` 10 Q. RDX-3.65, what does claim 20 require
`
` 11 additionally?
`
` 12 A. Claim 20 requires the smart watch according to
`
` 13 claim 18, wherein the heart rate parameter is a heart rate,
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` 14 wherein the heart rate is derived from the PPG signal.
`
` 15 Q. If we go to RDX-3.66, does the AMON reference
`
` 16 disclose this additional limitation of claim 20?
`
` 17 A. In my view it does. It specifically mentions an
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` 18 SpO2 sensor again, which is based or built off of PPG
`
` 19 sensors. Indeed, I have never seen an SpO2 sensor that did
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` 20 not entail PPG technology. And in the middle figure it
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` 21 specifically states that you can, from the SpO2, that there
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` 22 are calculations of pulse.
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` 23 Q. If we go to RDX-3.67, does AMON alone and/or in
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` 24 combination disclose all the limitations of claims 13, 16,
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` 25 18, 19, and 20?
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`
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