`
`Transcript of William J. Drasler,
`Ph.D.
`
`Date: May 19, 2021
`Case: Medtronic CoreValve LLC -v- Colibri Heart Valve LLC
`
`Planet Depos
`Phone: 888.433.3767
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`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
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`Colibri Heart Valve LLC, Exhibit 2020, Page 1 of 149
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` -----------------------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` -----------------------------------
` MEDTRONIC COREVALVE LLC,
` Petitioner,
` v.
` COLIBRI HEART VALVE LLC,
` Patent Owner.
` -----------------------------------
` Case No. IPR2020-01454
`
` VIDEOTAPED DEPOSITION OF WILLIAM J. DRASLER, PH.D.
` 2020-01454
` Wednesday, May 19, 2021
` 7:04 a.m. PT
`
`Job No.: 370472
`Pages: 1 - 117
`Reported By: Charlotte Lacey, RPR, CSR No. 14224
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`2
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` VIDEOTAPED DEPOSITION OF WILLIAM J. DRASLER, PH.D.,
`CONDUCTED VIRTUALLY.
`
` Pursuant to notice, before Charlotte Lacey,
`Certified Shorthand Reporter, in and for the State of
`California.
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`3
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` A P P E A R A N C E S
`ON BEHALF OF PETITIONER MEDTRONIC COREVALVE LLC:
` JAMES L. DAVIS, JR., ESQUIRE
` ROPES & GRAY LLP
` 1900 University Avenue, 6th Floor
` East Palo Alto, California 94303
` (650) 617-4000
`
`ON BEHALF OF PATENT OWNER COLIBRI HEART VALVE LLC:
` SARAH E. SPIRES, ESQUIRE
` PAUL SKIERMONT, ESQUIRE
` SKIERMONT DERBY LLP
` 1601 Elm Street, Suite 4400
` Dallas, Texas 75201
` (214) 978-6600
`
`ALSO PRESENT:
` Amy Lydon, Medtronic
` Ashby Everhart, AV Technician
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`4
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` I N D E X
` WITNESS PAGE
` WILLIAM J. DRASLER, PH.D.
` Examination by Ms. Spires 6
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` I N D E X O F E X H I B I T S
` EXHIBITS DESCRIPTION PAGE
`Exhibit 2019 U.S. Patent No. 6,475,237 108
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` PREVIOUSLY MARKED EXHIBITS
` EXHIBIT DESCRIPTION PAGE
`Exhibit 1001 U.S. Patent No. 9,125,739 11
`Exhibit 1002 Declaration of Dr. William J. 11
` Drasler in Support of Petition for
` Inter Partes Review of U.S. Patent
` No. 9,125,739
`Exhibit 1005 U.S. Patent No. 6,425,916 73
`Exhibit 1006 U.S. Patent No. 5,957,949 66
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`5
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`Exhibit 1010 International Publication No. 104
` WO 00/15147
`Exhibit 1013 U.S. Patent No. 5,840,081 93
`Exhibit 1020 U.S. Patent No. 5,961,549 40
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`6
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` P R O C E E D I N G S
` THE REPORTER: Will counsel please
`stipulate that in lieu of formally swearing in the
`witness, the reporter will instead ask the witness
`to acknowledge that their testimony will be true
`under the penalties of perjury, that counsel will
`not object to the admissibility of the transcript
`based on proceeding in this way, and that the
`witness has verified that he is, in fact,
`William J. Drasler, Ph.D.
` MS. SPIRES: Yes.
` MR. DAVIS: Yes.
` THE WITNESS: Yes for me too.
` THE REPORTER: Dr. Drasler, do you
`hereby acknowledge that your testimony will be
`true under the penalties of perjury?
` THE WITNESS: Yes, I do.
` THE REPORTER: Thank you.
` Proceed, Counsel.
` EXAMINATION
`BY MS. SPIRES:
` Q. Good morning, Dr. Drasler.
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`7
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` A. Good morning.
` Q. So I'm happy to be able to meet you in
`this way. That's very convenient, much more so
`than previous times.
` Have you been deposed before?
` A. Yes, this will be my fourth time that
`I've been deposed.
` Q. Okay. And do you remember the content
`of the other cases in which you've been deposed?
` A. Yes, I do.
` Q. And what was that?
` A. Okay. The first one was related to
`rapid-exchange catheters. This was with a company
`called Woodcock Washburn. It was a Boston
`Scientific against ACS. The second time was with
`Hogan Hartson. It was a lawsuit with AGA versus
`Occlutech. And then the last one was a -- and
`that one was sort of an occlusion device, so it
`was a vascular occlusion device. And then,
`lastly, I had an interaction with -- it was Dorsey
`Whitney, a lawsuit involving Vascular Solutions
`against Terumo, and that was a radial closure
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`8
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`device.
` Q. And do you recall if, in those cases,
`those were district court cases or proceedings
`like this one that's before the PTAB?
` A. Yes. They were not in front of the
`PTAB. It was district court proceeding.
` Q. Okay. This is fairly similar for your
`intents and purposes. If we come up to a spot
`where it's different, we'll let you know.
` A. Okay.
` Q. In those cases, do you recall if you
`were representing the plaintiff or the defendant
`in those cases?
` A. Yes. The first one, Boston
`Scientific -- or it was -- it was SciMed versus
`ACS. They were -- SciMed was the defendant. I
`was representing the defendant. The second one,
`AGA was the plaintiff. And the last one was
`Vascular Solutions was the defendant.
` Q. Okay. So since you've been deposed
`before, I'll just go through the rules really
`quickly. You probably already know them, but
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`9
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`verbal answers are important for the transcript.
`So nodding your head and things like that, while I
`can see you, that's tough to put on a transcript.
`So if you can answer verbally, that's helpful for
`the court reporter.
` Also, if you don't understand a question
`that I ask, I'm sure it's my fault for not being
`clear, but please ask for clarification because if
`you don't, I'm going to assume that you understood
`what I asked. It won't hurt my feelings if you
`ask me to clarify.
` A. Okay.
` Q. And then breaks, we can take them as
`often as you need them. All I ask is that if
`there's a question pending that you go ahead and
`answer the question and then ask for a break. But
`please feel free to ask for those whenever you
`need them.
` A. Okay.
` Q. Is there any reason you can't testify
`truthfully today?
` A. No.
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`10
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` Q. Did you prepare for today's deposition?
` A. Yes.
` Q. And how did you prepare for it?
` A. First, I started by reading through
`the -- the Paniagua '739 patent. Then I reviewed
`the file history, not all of it but certain
`aspects of it. Then I looked at each of the prior
`art that was found in my declaration. Then I read
`the declaration again. Okay. But I -- I wanted
`to get all prepared before I read the declaration
`so that it would come clear as to what was said
`and how it fit in the context.
` And then I had two discussions with Jim
`Davis, each one about three hours. Four hours, I
`think, for the first one; a little less than that
`for the second one. And we went over --
` MR. DAVIS: Just to caution you,
`Dr. Drasler, not to get into any actual
`discussions. But the amount of time is fine.
` A. Okay. Yeah.
` MR. DAVIS: The rest is privileged.
` A. So we reviewed the same things that I
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`11
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`had just mentioned that I had reviewed.
` Q. Have you spoken to someone named
`Dr. Hillstead about this case?
` A. No, I have not.
` Q. And are you aware that there's a
`district court case that's also currently dealing
`with the '739 patent that's at issue here?
` A. Not -- no. The answer is no.
` Q. Okay. And I heard you mention earlier
`the '739 patent. Is -- is it okay if I call it
`that as opposed to Exhibit 1001 or the whole
`patent number?
` A. Yes.
` Q. Okay. In your declaration, at -- which,
`I guess, just for the record, is Exhibit 1002 --
`and I understand you have hard copies of
`everything so we can pull anything up on screen,
`if you'd like, and you can search and also feel
`free to just use the hard copy, whatever you're
`more comfortable with.
` A. Yes.
` Q. So in your declaration, you said that
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`12
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`you're a consultant for an outside medical device
`company that is manufacturing and selling a large
`bore closure device for closing the femoral artery
`access site following transcatheter aortic valve
`replacement procedures; is that right?
` A. Yes, that's right.
` Q. What's the name of this outside device
`company?
` A. It is Teleflex, and they are the owners
`of a company called Essential Medical, which makes
`the -- it's called Manta closure device.
` Q. And you identified in your declaration
`several patented inventions that you had, right?
` A. I do have many patented inventions.
`I -- I can't remember if I -- I listed them in my
`declaration. Maybe I did --
` Q. I think you listed some but not all.
` A. Okay. The answer is yes.
` Q. Do you know, are you still the owner of
`all of your patented inventions?
` A. Well, no. The answer is that all
`those -- it shouldn't be all -- some of the
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`13
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`inventions listed would be owned by companies that
`I had worked for. And others are owned directly
`by myself.
` Q. Do you know whether Medtronic is the
`owner of any of your patented inventions?
` A. I do know Medtronic is not the owner of
`any of my patented inventions. Let me -- let me
`clarify that just a little bit. No, that is true.
`Okay. Medtronic is not the owner of any of the
`patented inventions.
` Q. What were you going to clarify?
` A. I couldn't remember who -- who bought
`Possis Medical, but it was Boston Scientific that
`bought Possis Medical, not Medtronic.
` Q. And do you know if Edwards is the owner
`of any of your patents?
` A. Edwards is not the owner of any of my
`patents.
` Q. And do you know if Edwards is an
`assignee or licensee of any of your patents?
` A. He is --
` MR. DAVIS: Objection to the extent that
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`14
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`this is going to get into any confidential
`conversation.
` Dr. Drasler, I'd caution you to let us
`know if that is the case, and we can designate the
`transcripts accordingly.
` A. Okay. Edwards is not a licensee or
`assignee of any of the patents.
` Q. And do you know if Medtronic is the
`licensee or assignee of any of your patents?
` A. Medtronic is not the licensee or
`assignee of any of the patents.
` Q. And I saw that you are -- have your own
`consulting company now; is that right?
` A. Yes.
` Q. And what work do you do for your own
`consulting company now?
` A. The -- the only work that I do is for
`that company that we mentioned, Teleflex, and I
`actually have not done any work for them for
`approximately six months. So the only thing that
`I've been doing is working on my -- my own
`inventions, which I write my own patents and file
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`15
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`them and prosecute them. And -- and working here
`on this case.
` Q. And I -- I don't want to get into
`anything that would be confidential, but for
`anything that you've disclosed, what are the
`inventions that you've been working on?
` A. The -- the one that has taken up the
`substantial amount of time is a mitral valve
`invention, a TMVR, so transcatheter mitral valve
`replacement device.
` Q. And what does that device do, to the
`extent it's not confidential?
` A. It is a different design for a TMVR
`device than the ones that are currently available.
` Q. And, again, to the extent that it's not
`confidential, what is the difference in the design
`of the TMVR device from what was previously
`available?
` A. It has a lower profile because the
`device is delivered in two components, first
`component being a docking station that can be
`delivered transseptally; the second component,
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`16
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`thereby being smaller, contains the valve. It is
`a stented valve that is then locked into the --
`the first component docking station.
` Q. And that two-component system for the
`TMVR device is different than what had existed
`before?
` A. The -- yes, it is different. But not to
`say that there are no other two-component devices.
`So other two-component devices either hook their
`mitral valve onto the inner leaflets and -- and/or
`have difficulty in delivering the two components.
`This particular system is delivered above the
`mitral septum and -- for the first component,
`which allows the mitral valve leaflets to continue
`functioning while you're then delivering your
`second component.
` Q. So it doesn't hook the mitral valve onto
`the inner leaflets?
` A. That's correct.
` Q. Interesting.
` Were there devices previously you had
`seen that didn't hook the mitral valve onto the
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`17
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`inner leaflets?
` MR. DAVIS: Objection; form.
` A. One of the companies named Caisson did
`try to make a two-component device that was
`transseptal that did hook around the native
`leaflets onto the back side of the leaflets but
`had very much difficulty. They eventually, after
`a few years, had to abandon that process and go
`out of business.
` Q. And do you recall when that was that
`they were trying to do that?
` A. I would say they went out of business
`approximately one year ago.
` Q. So they started a few years before that
`or so?
` A. That's correct.
` Q. There's one last intro question. Have
`you ever had any interactions with Colibri before?
` A. Not -- not significant. Colibri did
`have some activity on a dried leaflet so that you
`could provide a device in a -- in a dried form
`to -- in a packaged dry form. And I did approach
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`Conducted on May 19, 2021
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`18
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`the president and CEO -- I don't remember his
`name -- at TCT meeting maybe three years ago and
`asked if they would be interested in having a -- a
`mitral device they used their leaflets with. And
`the discussions did not really extend any further
`than that. My understanding was that Colibri was
`having some difficulties with their device and
`probably is the reason behind no further
`interactions on their part.
` Q. Okay. In your declaration, you set out
`some kind of legal premises, and I just wanted to
`get a little bit more understanding about those.
`And so, for instance, in paragraph 27 of your
`declaration.
` A. Okay.
` Q. I think, in that paragraph, you set out
`various legal principles that I believe were
`probably given to you by counsel; is that right?
` A. That is correct.
` Q. And one of them, you said that one
`should be cautious of using hindsight in
`evaluating whether a claimed invention would have
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`Conducted on May 19, 2021
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`19
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`be obvious; is that right?
` A. Yeah. Could you point out which
`particular bullet point that is?
` Q. Sure. It is the bottom bullet point on
`page 14.
` A. Yes, I read that, and I understand it,
`and I agree with it.
` Q. Do you have an understanding as to
`whether hindsight can ever be used in deciding
`whether a claimed invention would have been
`obvious?
` MR. DAVIS: Objection; form.
` A. I believe that if you had hindsight
`about combining different elements that were
`available to you in a manner that was not
`expected, did not provide an expected result, then
`it would not be obvious.
` Q. Okay. I want to make sure I understood
`what you said. Are you saying that hindsight is
`related to whether combining -- strike that.
` What do you mean by if you had hindsight
`about combining different elements in a manner
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`20
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`that was not expected?
` A. Okay. Hindsight, I believe, would mean
`that you're aware of something that is already out
`there, as opposed to foresight. You're looking
`back at something that is already out there,
`something that's available. Okay. So if you
`merely took that item that was available to you
`and try to write a patent on your -- on that, that
`would be considered obvious and would not be
`patentable.
` But let's -- let's say there was two
`things that were out there, and you're going to
`combine them in a -- a nonobvious way, in a way
`that is not -- gives an unexpected result, then I
`think it would not be obvious, and it would be
`patentable.
` Q. Do you have an understanding as to
`whether an unexpected result is required for the
`combination of two references to not be obvious?
` MR. DAVIS: Objection; form.
` A. Can you repeat that one more time?
`Sorry.
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`21
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` Q. Sure. Do you have an understanding as
`to whether an unexpected result is required for
`the combination of two references to not be
`obvious?
` MR. DAVIS: Same objection.
` A. Yeah I -- I believe that that type of
`question is -- goes beyond what I was asked to do
`here as an expert, and as a result, I think it --
`it perhaps is -- is beyond -- beyond where I
`should make my comment. I think that there's
`probably other -- other reasons that I can't go
`into because I'm not a patent attorney that would
`make something obvious other than the unexpected
`result.
` Q. Okay. I understand that well before
`January 4th, 2002, your level of ordinary -- your
`level of skill in the art was at least that of a
`person of ordinary skill based on the definition
`that you've set forth here, right?
` A. That's correct.
` Q. And if I asked you today about the
`person of ordinary skill in the art, can we all
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`Transcript of William J. Drasler, Ph.D.
`Conducted on May 19, 2021
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`22
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`just have the understanding that I'm talking about
`as of this January 4, 2002, date so I don't have
`to say the date every time?
` A. Yes.
` Q. Okay. Thank you. That makes things
`easier.
` Did you apply all of the experience that
`you set forth in your CV, your declaration, in
`reaching the opinions you set forth in your
`declaration?
` MR. DAVIS: Objection; form.
` A. In -- in reaching the decisions listed
`in the declaration, I always have to go back to
`where I was at -- in 2002 in what was known.
` Q. Right. I'll clarify --
` A. I can't identify everything that I know
`now that wasn't known then.
` Q. Fair. I'll clarify the question.
` So in reaching the opinions you set
`forth in your declaration, did you apply all of
`the experience that you set forth in your CV up to
`the January 4th, 2002, date?
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`Transcript of William J. Drasler, Ph.D.
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`23
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` MR. DAVIS: Objection; form.
` A. I have a -- I believe the answer is yes.
`I -- I would use anything and everything I knew up
`to that point in 2002.
` Q. In your declaration -- it's at
`paragraph 35 if you want to look -- you said that
`the '739 patent admits that its core components
`were already well known?
` A. That's correct.
` Q. What's your understanding of how the
`'739 patent's core components being already well
`known relates to obviousness?
` MR. DAVIS: Objection; form.
` A. Relates to obviousness...
` If -- if components are brought together
`in a manner that does not provide any unexpected
`result and would be obvious to somebody at --
`skilled in the art at the time, then it -- then it
`would not be a patentable device. It would be
`considered obvious. And that's what I have said.
` Q. So you've mentioned a few times that in
`your obviousness analysis, you looked for
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`unexpected results, right?
` MR. DAVIS: Objection; form.
` A. Can you show me where I said I looked
`for unexpected results?
` Q. It would just be in the real-time. What
`you said just a second ago, just reading your
`answer, you said, "If components are brought
`together in a manner that does not provide any
`unexpected result and would be obvious to someone
`skilled in the art at the time, then it would not
`be a patentable device. It would be considered
`obvious."
` A. Yeah. Let's just say, the second half
`of that, if it was known to an ordinary person
`skilled in the art, plus does not provide an
`unexpected result, then it would not be
`unobvious -- it would be obvious. So...
` Q. Okay. I want to skip ahead to
`paragraph 63 of your declaration.
` A. Okay.
` Q. And there, you're talking about what
`certain terms in the '739 patent mean. And, in
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`particular, in paragraph 63 you're talking about
`the term "trumpet-like," right?
` A. Yeah. It's talking about the
`increasingly flared openings in --
` Q. Right.
` A. -- paragraph 63.
` Q. Right. And so you said "Whatever may be
`the exact contours of this term." And "this term"
`you're referring to the term "trumpet-like"; is
`that right?
` A. The term that is in quotes in
`paragraph 62 is "flared markedly at both ends in a
`trumpet-like configuration."
` Q. Okay. And so that's the term that
`you're talking about when you say "Whatever may be
`the exact contours of this term"?
` A. Yes.
` Q. And then you said that the prior art
`discloses increasingly flared openings on both
`sides of the stent; is that right?
` A. Yes.
` Q. So is increasingly flared opening on
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`both sides of the stent the definition that you
`applied for the term "flare markedly at both ends
`in a trumpet-like configuration"?
` MR. DAVIS: Objection; form.
` A. For a device to have a trumpet-like
`configuration, it needs to show a increasingly
`flared configuration or shape.
` Q. Is there any other requirement for a
`device to have a trumpet-like configuration?
` MR. DAVIS: Objection; form.
` A. I'm sorry. Is there any other -- what
`was the --
` Q. Is there any other requirement for a
`device to have a trumpet-like configuration other
`than increasingly flared openings on both sides of
`the stent?
` MR. DAVIS: Objection; form.
` A. It has to flare -- the device has to
`flare at both ends, and the flare has to have a
`trumpet-like configuration.
` Q. Do you have an opinion as to what
`trumpet-like configuration means?
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` MR. DAVIS: Objection; form.
` A. Trumpet-like configuration means that it
`has a -- a shape similar to that of a trumpet.
`It -- increasingly flared.
` Q. Are there any requirements for having a
`shape similar to that of a trumpet other than
`increasingly flared?
` MR. DAVIS: Objection; form.
` A. The -- the aspect that is important to a
`stent is that part of the trumpet that
`increasingly flares. Other aspects of the trumpet
`are -- are not the basis behind describing the
`flare.
` Q. Okay. I'm just trying to clarify
`because it -- I know you have some opinions that
`certain prior art references disclose this element
`of flaring markedly at both ends in a trumpet-like
`configuration, right?
` A. Yes.
` Q. And so I was -- I'm trying to find out
`what you were looking for when you were
`determining whether these prior art references
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`flare markedly at both ends in a trumpet-like
`configuration?
` A. Yes.
` MR. DAVIS: Objection; form.
` A. The -- the shape of the ends of the
`stent that we would be considering need to have a
`increasingly flared configuration, like a trumpet.
` Q. And is there any other element that you
`were looking for in determining whether the prior
`art references that you cite flare markedly at
`both ends in a trumpet-like configuration?
` MR. DAVIS: Objection; form.
` A. One -- one looks at the shape of the
`distal ends of the stent to see if they flare in
`an increasingly flared manner. And if they do,
`then they would flare -- that is how a trumpet is
`shaped. So that would be -- that would be
`described as flaring in a -- with a trumpet-like
`configuration.
` Q. I know earlier you were talking about
`you are currently doing work with TMVR devices,
`right?
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` A. That's correct.
` Q. And so I want to start with the TAVR
`devices. I assume you're familiar with TAVR
`devices?
` A. Yes, I am.
` Q. Can you explain what a TAVR is?
` A. Yes. Transcatheter aortic valve
`replacement device.
` Q. And can you explain in just a bit more
`detail what a transcatheter aortic valve
`replacement device is?
` A. The -- the typical TAVR, or TAVR device,
`is introduced usually through the femoral artery
`with a catheter. There are other access sites
`that it can also be entered into the vasculature
`from, including the aorta; for example, indirectly
`across the aortic valve. But most of the ones
`that are in use enter into the femoral artery via
`catheter, then are snaked up through the aorta to
`the arch, and then are positioned adjacent to the
`aortic anulus such that when they are delivered,
`they will push the native leaflets aside, covering
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`them, and provide a stented structure that
`contains a replacement valve that then takes over
`the function of the native valve.
` Q. And how -- first, would a person of
`ordinary skill in 2002 have been familiar with a
`TAVR device?
` A. TAVR devices in 2002 were just beginning
`to come into play. You would go to the TCT
`meeting, and I would guess that a high percentage
`of the meeting sessions would be on this -- this
`new technique. They used to call it TAVI
`implantations instead of TAVR. And the -- all of
`the scientists were there as well as the doctors.
`So, yes, you would be familiar with them.
` Q. And I think you mention that the TAVR
`device will push the native leaflets aside in the
`aortic valve; is that right?
` A. That was the -- the direction that
`everybody was heading towards, because the goal
`was to try to eliminate the surgical removal of
`the valve. So you could, actually, do a surgical
`removal of the valve and then put in a replacement
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`31
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`valve. But the advantages of coming in with a
`catheter-placed valve after you've gone in
`surgically to remove leaflets is lost. And most
`devices that try to remove the leaflets via
`transcatheter procedure are kind of dangerous
`because you're in a position where a person can
`die on the table while you're trying to place the
`replacement device.
` So -- so the answe