Page 1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________________________________
`MEDTRONIC, INC., and
`MEDTRONIC VASCULAR, INC.,
`
`Petitioners,
`
`vs.
`
`TELEFLEX INNOVATIONS
`S.A.R.L.,
`
`Case No. IPR2020-00126
`U.S. Patent No. 8,048,032
`
`Patent Owner.
`___________________________________________________
`
`IPR2020-00126 (Patent 8,048,032 B2)
`IPR2020-00127 (Patent 8,048,032 B2)
`IPR2020-00128 (Patent RE45,380 E)
`IPR2020-00129 (Patent RE45,380 E)
`IPR2020-00130 (Patent RE45,380 E)
`IPR2020-00132 (Patent RE45,760 E)
`IPR2020-00135 (Patent RE45,776 E)
`IPR2020-00136 (Patent RE45,776 E)
`IPR2020-00137 (Patent RE47,379 E)
`IPR2020-00138 (Patent RE47,379 E)
`____________________________________________________
`
`VIDEOCONFERENCE VIDEOTAPED
`DEPOSITION OF
`PETER T. KEITH
`
`DATE: November 23, 2020
`
`TIME: 8:58 a.m.
`
`PLACE: Minneapolis, Minnesota
`
`(via videoconference)
`
`JOB NO.: MW 4338308
`
`REPORTED BY: Dawn Workman Bounds, CSR
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`Veritext Legal Solutions
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`IPR2020-01344
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`Medtronic Ex-1805
`Medtronic v. Teleflex
`Page 1 of 87
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`Page 2
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`Page 4
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`1 A P P E A R A N C E S
`2 (ALL APPEARANCES VIA VIDEOCONFERENCE)
`3 ON BEHALF OF PETITIONERS:
`4 SHARON ROBERG-PEREZ, ESQ.
` EMILY TREMBLAY, ESQ.
`5 CYRUS A. MORTON, ESQ.
` ROBINS KAPLAN LLP
`6 2800 LaSalle Plaza
` 800 LaSalle Ave
`7 Minneapolis, MN 55401
` 612.349.8500
`8 sroberg-perez@robinskaplan.com
` camorton@rkmc.com
`9 ETremblay@RobinsKaplan.com
`10
`11
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`16
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`18
`19
`20
`21
`22
`23 (APPEARANCES CONTINUED ON NEXT PAGE)
`24
`25
`
`1 I N D E X
`2 WITNESS: PETER T. KEITH PAGE
`3 EXAMINATION BY MS. ROBERG-PEREZ.................... 6
`4 EXAMINATION BY MR. VANDENBURGH..................... 181
`5 EXHIBITS MARKED/REFERRED TO
`6 No. 1118: Picture/diagram of GuideLiner
` Version 2 EX-2138, IPR2020-00132,
`7 p. 150.................................. 83
`8 No. 1119: Picture/diagram of GuideLiner
` Version 2 EX-2138, IPR2020-00132,
`9 pp. 150; 152............................ 84
`10 No. 1120: U.S. Patent 5,658,251................... 155
`11 No. 1121: U.S. Patent 5,156,594................... 162
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`Page 3
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`Page 5
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`1 ON BEHALF OF PATENT OWNER:
`2 DEREK VANDENBURGH, ESQ.
` JOSEPH W. WINKELS, ESQ.
`3 CARLSON CASPERS VANDENBURGH & LINDQUIST, PA.
` Capella Tower, Suite 4200
`4 225 South Sixth Street
` Minneapolis, MN 55402
`5 612.436.9623
` dvandenburgh@carlsoncaspers.com
`6 jwinkels@carlsoncaspers.com
`7 KENNETH E. LEVITT, ESQ.
` DORSEY & WHITNEY, LLP
`8 50 S. Sixth Street, Suite 1500
` Minneapolis, MN 55402
`9 612.340.2600
` levitt.kenneth@dorsey.com
`
`10
`11 ALSO PRESENT:
`12 Greg Smock, Teleflex
`13 Adam Venturini, Videographer
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1 P R O C E E D I N G S
`2 THE VIDEOGRAPHER: Good morning. We are
`3 going on the record at 8:58 a.m. Eastern Standard Time,
`4 on November 23, 2020. Please note that the microphones
`5 are sensitive and may pick up whispering, private
`6 conversations, and cellular interference. Please turn
`7 off all cell phones and place them away from microphones
`8 as they can possibly interfere with deposition audio.
`9 Audio and video recording will continue to take place
`10 unless all parties agree to go off the record.
`11 This is media unit 1 of the video-recorded
`12 deposition of Peter T. Keith, in the matter of Medtronic
`13 v. Teleflex Innovations. My name is Adam Venturini from
`14 the firm Veritext, and I'm the videographer. The court
`15 reporter is Dawn Bounds from the firm Veritext.
`16 I'm not authorized to administer an oath.
`17 I'm not related to any party in this action nor am I
`18 finally interested in the outcome.
`19 Counsel and all present remotely will now
`20 state their appearances and affiliations for the record.
`21 If there are any objections to proceeding, state them at
`22 the time of your appearance, beginning with the noticing
`23 attorney.
`24 MS. ROBERG-PEREZ: Sharon Roberg-Perez
`25 representing Petitioner Medtronic of the firm Robins
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`Page 6
`1 Kaplan. With me are my colleagues Cy Morton and Emily
`2 Tremblay.
`3 MR. VANDENBURGH: This is Derek
`4 Vandenburgh here today on behalf of Teleflex.
`5 Also appearing is Joe Winkels of the Carlson Caspers
`6 firm, as well as Ken Levitt of the Dorsey firm; and Greg
`7 Smock of Teleflex is here as well.
`8 THE VIDEOGRAPHER: All right. Will the
`9 court reporter please swear in the witness.
`10 THE REPORTER: Due to the need for this
`11 deposition to take place remotely because of the
`12 government's order for physical distancing, the parties
`13 will stipulate the court reporter may swear in the
`14 witness over the videoconference and that the witness has
`15 verified that he is in fact Peter T. Keith.
`16 Agreed, counsel?
`17 MS. ROBERG-PEREZ: Agreed.
`18 MR. VANDENBURGH: Agreed.
`19 PETER T. KEITH,
`20 duly sworn via videoconference as stipulated by counsel
`21 was examined and testified as follows:
`22 EXAMINATION
`23 BY MS. ROBERG-PEREZ:
`24 Q. Good morning, Mr. Keith.
`25 You've been deposed before, haven't you?
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`Page 8
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`1 Q. Okay. Is there any reason today, such as
`2 illness or medication, that you will not be able to
`3 testify fully and accurately?
`4 A. No.
`5 Q. You've submitted declarations in several IPRs
`6 initiated by Medtronic, right?
`7 A. Yes.
`8 Q. You've also submitted declarations in
`9 connection with the district court litigation that
`10 Teleflex initiated against Medtronic, right?
`11 A. Yes.
`12 Q. Aside from counsel, have you spoken about the
`13 IPRs with anyone?
`14 A. No.
`15 Q. What about the district court litigation?
`16 A. No.
`17 Q. You're familiar with the name Tom Ressemann,
`18 right?
`19 A. Yes, I am.
`20 Q. Have you spoken with him in the last six
`21 months?
`22 A. Yes, I have.
`23 Q. What about?
`24 A. Well, we're -- we have a friendship. We've
`25 worked together professionally. I've spoken to him about
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`Page 7
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`Page 9
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`1 A. I have, yes.
`2 Q. About how many times?
`3 A. I -- it's -- I've been deposed many times over
`4 a long career in medical devices, so I don't really have
`5 a particular figure, but probably could be approaching 20
`6 times maybe.
`7 Q. Okay. Have you ever testified at trial?
`8 A. I have.
`9 Q. How many times?
`10 A. Just one time for that.
`11 Q. And when was that?
`12 A. That was, I believe, in the early 2000s.
`13 Q. Was that a patent matter?
`14 A. Yes.
`15 Q. And who did you testify for?
`16 A. I testified on behalf of Boston Scientific.
`17 Q. Was Boston Scientific the plaintiff in that
`18 case or defendant?
`19 A. Well, it was a complicated proceeding that I
`20 think they were a plaintiff in aspects and a defendant in
`21 aspects, I believe.
`22 Q. Were you an expert witness in that trial?
`23 A. Yes, I was.
`24 Q. Do you recall who prevailed in that trial?
`25 A. I believe it was a settlement.
`
`1 some companies that he's involved with that I have
`2 offered some thoughts and comments in terms of potential
`3 employment opportunities that he's looked into.
`4 He sits on the board of directors of a few
`5 companies, one of which he talked with -- or he and I
`6 talked about, and I have done a little bit of consulting
`7 with that company.
`8 Q. And to confirm, you have not spoken with him
`9 about the subject matter of these IPRs, correct?
`10 A. Correct. He knows that I'm involved in this
`11 patent litigation, but I've not spoken about any subject
`12 matter.
`13 Q. Okay. Who wrote your declarations submitted in
`14 these IPRs?
`15 A. They're my declarations.
`16 Q. And so you wrote these declarations?
`17 A. I -- they're certainly my words. The process
`18 of the writing was done, you know, in coordination with
`19 the lawyers; but I -- I -- you know, I drafted much of --
`20 you know, did the initial drafts of much of them.
`21 You know, they may have done some initial
`22 drafting of portions, and -- but it was always -- there
`23 was always an extraordinary amount of discussion and
`24 editing; and at the end of the day, they're my words.
`25 Q. Okay. Now, in connection with the drafting,
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`1 was there any material, other than what you've cited in
`2 your declarations, that you considered?
`3 A. I don't believe so.
`4 Q. Anything that -- any material that you reviewed
`5 but did not cite in your declarations?
`6 A. I don't think so.
`7 Q. How did you prepare for your deposition today?
`8 A. I rereviewed my declarations and some of the
`9 other materials in the case, and I had some conversations
`10 with counsel.
`11 Q. How long were those conversations?
`12 A. I mean, in the last several days, say, the
`13 conversations that I've had with counsel have probably
`14 been maybe 10 hours.
`15 Q. Did you review any of the material cited in
`16 your declarations?
`17 A. I think so.
`18 Q. What material?
`19 A. I looked at the root patents. I looked at a
`20 number of the prior art patents that are of relevance to
`21 the case. Those are things that I can think of.
`22 I probably looked at more, but I can't
`23 recall them right now.
`24 Q. Did you review any material not cited in your
`25 declarations?
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`Page 12
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`1 Q. Well, what is a cutting balloon?
`2 A. There's one product in particular -- this is a
`3 long, long time ago.
`4 But there's one product in particular that
`5 was referred to as a "cutting balloon" that had
`6 essentially some short longitudinal razor blades affixed
`7 to the surface of the balloon.
`8 Q. Was that a Boston product or a Grayzel product?
`9 A. This was so long ago, I -- honestly, I don't
`10 remember.
`11 Q. You testified on behalf of Boston, though,
`12 right?
`13 A. Yes.
`14 Q. What was your opinion in the case?
`15 A. I don't recall.
`16 Q. To the extent you can -- okay.
`17 Do you remember if you opined on claim
`18 construction?
`19 A. I don't recall.
`20 Q. Okay. You also in your CV list a case Boston
`21 Scientific v. Cordis on behalf of the plaintiffs.
`22 What was the technology at issue in that
`23 case?
`24 A. That, I believe, was related to multilayer
`25 extrusions used in angioplasty catheters.
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`Page 11
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`Page 13
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`1 A. I don't think so.
`2 Q. Did you attend the depositions given by
`3 Dr. Graham?
`4 A. No.
`5 Q. Have you reviewed his testimony?
`6 A. No.
`7 Q. Okay. You testified that you've previously
`8 been deposed.
`9 And am I correct those depositions were
`10 largely in patent cases?
`11 A. Yes.
`12 Q. And you testified truthfully in those cases,
`13 right?
`14 A. Yes.
`15 Q. I'd like to understand what types of cases
`16 those were.
`17 Your CV mentions a matter Grayzel versus
`18 Boston Scientific?
`19 A. Yes.
`20 Q. What was the technology at issue in that case?
`21 A. I believe that related to balloon angioplasty
`22 catheters and some aspects of -- of the balloon itself in
`23 terms of having cutting elements or rigid elements.
`24 Q. Does that refer to a cutting balloon?
`25 A. Yes. Sure, that's one way to describe it.
`
`1 Q. Was that the case that you testified at trial?
`2 A. Yes.
`3 Q. Do you remember what your -- and you testified
`4 as an expert, right?
`5 A. Correct.
`6 Q. Did you also testify at a claim construction
`7 hearing in that case?
`8 A. I don't think so.
`9 Q. Do you remember what your opinion was in that
`10 case?
`11 A. No. Again, that was so long ago and, you know,
`12 very involved. I do not recall.
`13 Q. Okay. Your CV also lists a matter SciCo v.
`14 Boston Scientific.
`15 What was the technology in that case?
`16 A. I believe that was related to some design
`17 aspects of rapid exchange angioplasty catheters.
`18 Q. Do you -- do you remember what your opinion was
`19 in that case?
`20 A. No.
`21 Q. Okay. Aside from those three matters, what
`22 other patent matters have you offered testimony in?
`23 A. I have been a fact witness in a number of
`24 patent cases. I think at least primarily related to my
`25 work at SCIMED Life Systems, which became part of Boston
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`Page 14
`1 Scientific, related to various angioplasty catheters that
`2 I either designed or was an inventor on.
`3 Q. So did those matters account for the lion's
`4 share of the 20 or so depositions you mentioned?
`5 A. Yes.
`6 Q. Okay. You've got a bachelor's degree in
`7 mechanical engineering, right?
`8 A. Yes.
`9 Q. And you mentioned your work for SCI -- SCIMED.
`10 And when did you start working at SCIMED?
`11 A. Well, I think all this is laid out on my
`12 resume, but I believe that was 1985.
`13 Q. And SCI -- I'm correct in understanding that
`14 SCIMED's products included interventional cardiology
`15 products?
`16 A. Well, I mean, interventional cardiology
`17 products is a particular term that's used in some of the
`18 patents at issue here, so I -- I -- I don't know what
`19 context you're asking me that question.
`20 Q. Do the patents use the term "interventional
`21 cardiology products"?
`22 A. I think they use "interventional cardiology
`23 devices."
`24 Q. Okay. Understood.
`25 So I'm not -- I'm trying to stay away from
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`Page 15
`1 patent terms, and I'm really just interested in the types
`2 of products that you worked on when you were at SCIMED.
`3 You mentioned one type, balloon
`4 angioplasty catheters, I think; is that correct?
`5 A. Yes.
`6 Q. What other types of interventional cardiology
`7 products did you work on at SCIMED?
`8 A. Well, I just want to be clear that we're
`9 talking about -- I mean --
`10 Q. Products.
`11 A. -- not specifically to what that term might
`12 strictly mean in the context of the patents, but if -- I
`13 mean, it sounds like you're trying to ask it in -- you
`14 know, in maybe a broader sense of interventional
`15 cardiology.
`16 Q. Mr. Keith --
`17 A. I --
`18 Q. -- can we agree that the patents do not refer
`19 to "interventional cardiology products"?
`20 A. They refer to "interventional cardiology
`21 devices."
`22 Q. Correct.
`23 And my question to you --
`24 A. Very similar terms.
`25 Q. But they're not the same term, are they?
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`Page 16
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`1 A. No, they're not exactly the same.
`2 Q. Okay. All I want to know is what kind of
`3 products -- I won't even use a modifier.
`4 What kind of products did you do work on
`5 at SCIMED?
`6 A. So I worked on fixed wire angioplasty catheter
`7 products. I worked on rapid exchange angioplasty
`8 catheter products. I worked on guidewires. I worked on
`9 atherectomy catheters. I worked on vascular sealing
`10 products. I worked on drug delivery products.
`11 And I probably worked on other products,
`12 but I can't recall other ones sitting here right now.
`13 Q. Okay. So you mentioned fixed wire angioplasty
`14 products, rapid exchange angioplasty products,
`15 guidewires, atherectomy catheters, vascular sealing
`16 products, and drug delivery products.
`17 Of those six categories, which of those
`18 products are introduced into the coronary vasculature?
`19 A. I would say all of those with the exception of
`20 vascular sealing products.
`21 Q. So when you mentioned drug delivery products,
`22 what type of products were you referring to?
`23 A. These would be products that -- they were
`24 catheters that would go into coronary arteries for the
`25 purpose of being able to deliver a drug.
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`Page 17
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`1 Q. Were these drug-eluting stents?
`2 A. No.
`3 Q. So of the fixed wire angioplasty products, how
`4 many were there?
`5 Do you remember their names?
`6 A. There were -- the first family of products --
`7 and by family I'm referring to that the balloons were
`8 available in different inflated diameters as well as
`9 different coil tip lengths. Those were referred to the
`10 as the ACE catheters.
`11 And then I was involved in some -- some
`12 more recent products after the ACE was introduced that
`13 were called the Pivot products. Again, there may be
`14 more. I'm just recalling all of them as I sit here
`15 today.
`16 Q. But for the fixed wire angioplasty products,
`17 there were at least the ACE and the Pivot products,
`18 right?
`19 A. Correct.
`20 Q. Do you remember what the names were of the
`21 rapid exchange angioplasty products?
`22 A. The one I was most directly involved with was
`23 the Express catheter. And then there were some more
`24 recent products that -- one was referred to as the Rally.
`25 And, again, there may be some others that
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`Page 18
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`1 I'm just not recalling sitting here today.
`2 Q. Do you recall a product by the name of
`3 Rendezvous?
`4 A. No.
`5 Q. Okay. What were the names of the guidewire
`6 products that you worked on?
`7 A. I think those -- well, the first products that
`8 I recall that were developed, which I wasn't particularly
`9 involved with, was the Enteer.
`10 And then I -- my involvement related to
`11 more recent products, but I can't remember the product
`12 names.
`13 Q. What atherectomy catheters were you involved
`14 with?
`15 A. I was involved in the development of a couple
`16 of different catheter -- atherectomy catheter designs
`17 that were never commercialized, so they didn't end up
`18 getting a name.
`19 Q. But there were two different designs?
`20 A. Yes.
`21 Q. Are there patents on these designs?
`22 A. At least on one. I think probably on both.
`23 Q. And understanding that these were never
`24 products that were launched, are there names of these
`25 catheters?
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`Page 20
`1 Q. Okay. Of the catheters that were designed to
`2 go into the coronary artery to deliver a drug, what were
`3 the names of those products?
`4 A. One that I recall was called the Dispatch
`5 catheter. And I think there's at least one other that I
`6 don't recall the name.
`7 Q. Okay. Let's start with the ACE.
`8 Well, before we do that, what's the
`9 difference between an angioplasty catheter and an
`10 atherectomy catheter?
`11 A. Well, there are numerous differences, but I'll
`12 highlight one difference, which is a balloon angioplasty
`13 catheter has an expandable balloon, which is used to --
`14 to dilate the lesion in the coronary artery.
`15 And generally an atherectomy catheter goes
`16 in; and rather than dilates, it tries to actually remove
`17 that lesion either by cutting or abrading.
`18 Q. And is the goal of using a balloon angioplasty
`19 catheter to dilate a lesion, is the goal to ensure that
`20 there's blood flow in the coronary vasculature?
`21 A. The goal is to improve the blood flow.
`22 Q. And is the goal for using an atherectomy
`23 catheter to remove or cut or abrade material to improve
`24 blood flow through coronary vasculature?
`25 A. I would say that's also a goal with
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`Page 21
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`1 A. Not other than just the -- sort of the generic
`2 atherectomy catheter.
`3 The projects probably had names, sort of
`4 internal to the development team, internal to the
`5 company, but I don't recall what those were.
`6 Q. And so you said at least one of these
`7 atherectomy catheters, there is a patent on and probably
`8 for the other one, too.
`9 How are these catheters different from
`10 each other?
`11 A. I actually don't -- I recall one of them more
`12 specifically, and my role at the time was managing a
`13 department at SCIMED that was called "new modalities."
`14 So we had engineers that were more
`15 directly involved in the day-to-day development, but I
`16 was involved from -- at sort of a higher level from a
`17 managerial standpoint, so that's why -- is partly why the
`18 details are little bit less clear in my ability to recall
`19 those.
`20 Q. Of the two catheters that you referred to,
`21 which of the atherectomy catheters do you recall better?
`22 You said you recall one better than the
`23 other. Which one is that?
`24 A. One of them was a -- it was an expan -- it was
`25 called an expandable atherectomy catheter.
`
`1 atherectomy.
`2 Q. What about the Dispatch catheter that you
`3 talked about, is that -- is the goal of using that
`4 catheter also to improve blood flow in the coronary
`5 vasculature.
`6 A. Well, that catheter was designed to be able to
`7 deliver a drug agent to the lesion or the vessel wall
`8 under the lesion as a -- more as an adjunctive treatment.
`9 Q. Adjunctive to what?
`10 A. Could be adjunctive to an angioplasty or
`11 perhaps an atherectomy treatment.
`12 Q. And we've already talked about how both
`13 angioplasty and atherectomy are directed to improving
`14 blood flow in the coronary vasculature, right?
`15 A. At a very high level, yes.
`16 Q. Have you observed angioplasty procedures?
`17 A. Yes.
`18 Q. About how many?
`19 A. Oh, I mean, many, many -- I mean, during the
`20 development of these devices, it was common to be able to
`21 observe angioplasty procedures both directly in the cath
`22 lab as well as at -- you know, more remotely via video at
`23 conferences. But I -- you asked me about a number. I
`24 can't really put a number on it.
`25 Q. Well, when you were developing an angioplasty
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`Page 22
`1 catheter, would you say you observed a procedure on a
`2 weekly basis or not that frequent?
`3 A. It wouldn't be quite so regular as that.
`4 Q. Maybe on a monthly basis?
`5 A. Again, that's implying sort of a level of
`6 regularity. I mean, it would be, you know, more
`7 clustered around the -- maybe the early development
`8 stages of the project. And then maybe towards the -- as
`9 the device is being used for the first times, that it was
`10 often a worthwhile endeavor to observe cases at that
`11 stage as well in a product -- in the product life cycle.
`12 Q. Okay. So understanding that there wasn't so
`13 much a regularity to your observations, in the early
`14 stages of the development of an angioplasty product, how
`15 many times would you observe angioplasties?
`16 A. Well, physically, in person probably half a
`17 dozen to a dozen times.
`18 Q. And about how many times as the product
`19 approached its first use?
`20 A. Probably similar, maybe more.
`21 Q. And these instances in which you would be
`22 observing angioplasty procedures, would you make these
`23 observations for each product that you were involved in
`24 the development of?
`25 A. Certainly the ACE and the Express products, I
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`Page 23
`1 would have -- you know, that would have been my level of
`2 observing procedures. I think for some of the other
`3 products that -- you know, at that point I was in more of
`4 a managerial capacity, so I probably was a little bit
`5 less involved in specific procedures related to those
`6 technologies.
`7 But, there again, I would have been still
`8 observing cases, you know, with our physician advisors.
`9 So I mean, even though they may have been little bit less
`10 specific to those development projects and those
`11 particular products, I still would have had some
`12 opportunities to be observing procedures directly.
`13 Q. Have you observed atherectomy procedures?
`14 A. I think so. I don't know for sure.
`15 Q. You think so.
`16 Okay. Sorry. How do you -- you say you
`17 think so. You don't know for sure.
`18 What do you mean by that?
`19 Were you in a procedure where more than
`20 one technique was used?
`21 A. No. I just -- what I mean by that is that I
`22 was less directly involved in the day-to-day design work
`23 on those projects; but I was, you know, quite familiar
`24 with the -- you know, generally the -- like other types
`25 of atherectomy catheter devices, like the ROTABLATOR
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`Page 24
`1 device. And I -- I believe I probably would have seen
`2 some procedures where that device was used.
`3 Q. Was the ROTABLATOR device a Boston -- sorry --
`4 a SCIMED product?
`5 A. Well, it's a -- it was developed by a company
`6 called Heart Technologies, which was then acquired by
`7 SCIMED and ultimately by Boston Scientific via SCIMID.
`8 Q. Okay. Other than the ROTABLATOR device that
`9 you referred to, do you remember seeing any other
`10 procedures involving an atherectomy catheter?
`11 A. I don't have a specific recollection of the
`12 procedures. The other atherectomy catheter that I -- was
`13 in -- was commercially available is the PBI atherectomy
`14 catheter.
`15 There again, I probably have seen some of
`16 those cases in person. And I certainly would have seen
`17 them via medical conferences that I would have attended
`18 in those days.
`19 Q. Do you recall how long the ACE catheter was?
`20 A. Not exactly.
`21 Q. Do you recall --
`22 A. I think it was about 140 centimeters.
`23 No, I'm -- no.
`24 Yeah, no, I think that's right.
`25 Q. Was the ACE catheter of uniform rigidity
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`Page 25
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`1 along its longitudinal axis?
`2 A. What do you mean by uniform rigidity?
`3 Q. Well, as a mechanical engineer, what's your
`4 understanding of catheter rigidity?
`5 A. Well, there can be a lot of definitions of
`6 rigidity.
`7 Q. And --
`8 A. There's axial, there's lateral, there's column
`9 strength, there's -- just to name a few -- compression.
`10 Q. You said axial, lateral, column strength, and
`11 compression.
`12 Was the ACE -- did the ACE catheter have
`13 uniform axial rigidity along its longitudinal axis?
`14 A. Well, even with axial, I think we have to be
`15 more specific than that.
`16 There's sort of a bending rigidity
`17 approach to that, or there's also sort of a column
`18 approach to -- to that rigidity.
`19 Q. And is the column approach to axial rigidity,
`20 is that different than column strength?
`21 A. Could be.
`22 Q. So with the ACE catheter, was its axial bending
`23 rigidity uniform along its longitudinal axis?
`24 A. Bending rig -- okay. Here again, I want to be
`25 absolutely clear that we're -- that we know what the
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`Medtronic Ex-1805
`Medtronic v. Teleflex
`Page 7 of 87
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`Page 26
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`Page 28
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`1 definition of these terms are.
`2 I mean, I was throwing those terms out in
`3 sort of a high level, general way just to illustrate that
`4 there can be many ways that one could think about the
`5 rigidity of a device.
`6 So if you want to be more specific, I'd be
`7 happy to do that. I -- it seems like you may maybe have
`8 a particular thing that you're looking for, and I'm not
`9 exactly sure what you're looking for.
`10 Q. Understood.
`11 Well, you have patents on angioplasty
`12 catheters, right?
`13 A. Yes.
`14 Q. In some of those patents, you refer to portions
`15 of the catheter being relatively flexible right?
`16 A. I don't have those patents in front of me.
`17 It certainly wouldn't surprise me if I
`18 used those terms.
`19 Q. And would you also not be surprised that in
`20 some of those patents you've used to term "relatively
`21 stiff"?
`22 A. Again, I wouldn't be surprised, but I don't
`23 have those patents in front of me.
`24 Q. And that's fine.
`25 So going back to the ACE catheter, would I
`
`1 diameter.
`2 Q. How did you make sure the tip was atraumatic?
`3 A. Well, at least one thing that I recall doing is
`4 doing some testing in -- in some animals.
`5 But it's -- you know, it was very similar
`6 in design to other products that have -- like the distal
`7 portions of guidewires.
`8 Q. Similar how --
`9 A. So --
`10 Q. Similar how?
`11 A. In the construction.
`12 Q. You mean in the materials used to construct it?
`13 A. Materials, dimensions.
`14 Q. What materials were used?
`15 A. Stainless steel and a platinum-iridium alloy.
`16 Q. Was there any polymer used?
`17 A. Not in the distal 2 millimeters.
`18 Q. Okay. So let's then move more proximal of the
`19 distal 2 millimeters. Let's just consider say the next
`20 100 millimeters after the most distal 2 millimeters.
`21 Would it be fair to think of that next 100
`22 millimeters as being relatively flexible?
`23 A. Again, I'm not sure we've really described
`24 exactly what that means.
`25 But, you know, it had the ability to bend
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`Page 27
`1 be correct in assuming that there are portions of the ACE
`2 catheter that are relatively flexible and portions of the
`3 ACE catheter that are relatively stiff?
`4 A. Well, again, it depends on how you measure it
`5 and exactly what that definition is.
`6 I mean, there -- there could be, depending
`7 on how you measure it.
`8 Q. Well, let's consider the -- the distal 2
`9 millimeters of the ACE catheter.
`10 Was the distal 2 millimeters of the ACE
`11 catheter flexible?
`12 A. I don't really know how to answer that.
`13 Q. You're familiar with coronary catheters, having
`14 worked on many of them over your career, right?
`15 A. Yes.
`16 Q. What properties do you want in the distal 2
`17 millimeters of a coronary catheter?
`18 A. It depends on the catheter.
`19 Q. ACE catheter.
`20 A. The distal 2 millimeters of the ACE catheter
`21 are a portion of the -- of the coil tip of the device.
`22 So at least a couple of properties that I
`23 think are -- could be considered important would be
`24 that it's -- it's atraumatic, that it's visible on an
`25 x-ray, and that's about 14 thousandths of an inch in
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`Page 29
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`1 and navigate into coronary arteries.
`2 Q. And having the property -- or the ability to
`3 bend and navigate into coronary arteries, that was also
`4 true of the most distal 2 millimeters, right?
`5 A. Well, the most distal 2 millimeters were part
`6 of the -- of the coil tip. So -- and, you know, taken as
`7 a whole, the coil tip certainly had that ability.
`8 Q. Okay. So now, I'd like to move to the distal
`9 most 300 millimeters of the ACE catheter.
`10 Would that section have had the ability to
`11 bend and navigate into the coronary artery?
`12 A. You're asking questions -- I mean, if I had a
`13 blueprint of that device in front of me, probably it
`14 would be easier. I don't know exactly what the -- all
`15 the structure of the ACE catheter was in the distal most
`16 300 millimeters.
`17 Q. I'm not asking about the exact structure.
`18 I'm asking if the d