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`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.,
`
` 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)
`IPR2020-00134 (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)
`___________________________________________________
`
` VIDEOTAPED DEPOSITION OF
` PETER KEITH
`
`DATE: November 24, 2020
`
`TIME: 9:00 a.m. (Central Standard Time)
`
`PLACE: Veritext Virtual Videoconference
`
`REPORTED BY: PAULA K. RICHTER, RMR, CRR, CRC
`
`www.veritext.com
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`888-391-3376
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`Page 1
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`
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`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex-1800
`Medtronic v. Teleflex
`
`

`

`Page 2
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`1 INDEX
`
`Page 4
`
`2 3
`
`WITNESS: PETER KEITH PAGE:
`4 EXAMINATION BY MR. MORTON.................. 6
`5 EXAMINATION BY MR. WINKELS................. 193
`
`6 7 8
`
`EXHIBITS MARKED: PAGE:
`9 EXHIBIT 1122 Photos of GuideLiner Versions
`10 1, 2 and 3...................... 43
`11 EXHIBIT 1123 U.S. Patent 7,422,579........... 146
`12
`13 (Original exhibits attached to original transcript;
`14 copies provided to counsel.)
`15
`16 EXHIBITS PREVIOUSLY MARKED AND REFERRED TO:
`17 EXHIBIT 1008 U.S. Patent 7,604,612.......... 159
`18 EXHIBIT 1009 U.S. Patent 5,439,445.......... 69
`19 EXHIBIT 1035 U.S. Patent Application
`20 Publication US2004/0010280..... 99
`21 EXHIBIT 2138 Declaration of Peter Keith
`22 in IPR2020-00127............... 83
`23
`24
`25
`
`1 APPEARANCES
`2 (All parties appeared via videoconference)
`
`3 4
`
`ON BEHALF OF THE PETITIONERS:
`5 Mr. Cyrus A. Morton, Esq.
`6 Mr. Christopher A. Pinahs, Esq.
`7 ROBINS KAPLAN, LLP
`8 800 LaSalle Avenue, Suite 2800
`9 Minneapolis, Minnesota 55401
`10 (612) 349-8500
`11 cmorton@robinskaplan.com
`12 cpinahs@robinskaplan.com
`13
`14 ON BEHALF OF THE PATENT OWNER:
`15 Mr. Joseph W. Winkels, Esq.
`16 Mr. J. Derek Vandenburgh, Esq.
`17 CARLSON, CASPERS, VANDENBURGH & LINDQUIST
`18 225 South Sixth Street, Suite 4200
`19 Minneapolis, Minnesota 55402
`20 (612) 436-9600
`21 jwinkels@carlsoncaspers.com
`22 dvandenburgh@carlsoncaspers.com
`23
`24
`25 (APPEARANCES continued on next page)
`
`Page 3
`
`Page 5
`
`1 P R O C E E D I N G S
`2 THE VIDEOGRAPHER: Good morning. We
`3 are going on the record at 9:00 a.m. CST, on
`4 Tuesday, November 24th, 2020. Audio and video
`5 recording will continue to take place unless all
`6 parties agree to go off the record.
`7 This is Media Unit 1 of the
`8 video-recorded deposition of Peter Keith, in the
`9 matter of Medtronic versus Teleflex Innovations,
`10 filed in the Patent Trial and Appeals Board, case
`11 number IPR2020-00127.
`12 The deposition is being held via
`13 video conference. My name is Craig Jones, from
`14 the firm Veritext Midwest, and I'm the
`15 videographer. The court reporter is Paula
`16 Richter, from the firm Veritext Midwest.
`17 I am not related to any party in
`18 this action, nor am I financially interested in
`19 the outcome.
`20 Counsel and all present in the room
`21 and everyone attending remotely will now state
`22 their appearance and affiliations for the record.
`23 If there are any objections to proceeding, please
`24 state them at the time of your appearance,
`25 beginning with the noticing attorney.
`
`1 APPEARANCES (Continued)
`
`23
`
`ON BEHALF OF PATENT OWNER:
`4 Mr. Kenneth E. Levitt, Esq.
`5 THE DORSEY FIRM
`6 50 South Sixth Street, Suite 1500
`7 Minneapolis, Minnesota 55402
`8 (612) 340-2600
`9 levitt.kenneth@dorsey.com
`10
`11
`12 ALSO PRESENT BY VIDEOCONFERENCE:
`13 Craig Jones - Videographer
`14 Grant Franks - Veritext Concierge
`15 Greg Smock - Teleflex
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
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`1 MR. MORTON: Good morning. This is
`2 Cyrus Morton from the law firm of Robins Kaplan,
`3 on behalf of Petitioner Medtronic. With me also
`4 is Christopher Pinahs.
`5 MR. WINKELS: On behalf of patent
`6 owner, Joe Winkels with the Carlson Caspers firm.
`7 With me from Carlson Caspers is Derek Vandenburgh.
`8 Also on the line is Ken Levitt, from The Dorsey
`9 Firm, and Greg Smock from Teleflex.
`10 THE VIDEOGRAPHER: Will the court
`11 reporter please swear in the witness.
`12 PETER KEITH,
`13 duly sworn, was examined and testified as follows:
`14 EXAMINATION
`15 BY MR. MORTON:
`16 Q. All right. Good morning, Mr. Keith. I know
`17 you were deposed yesterday and a lot of your
`18 background was covered, so I'll try not to be too
`19 repetitive on that. But I do want to walk through
`20 some things that are in your declaration,
`21 specifically your declaration for the '032 patent
`22 in IPR2020-00127.
`23 Do you have that available?
`24 A. I do.
`25 Q. Okay. And we'll be walking through that and
`
`1 inspected the devices, does that mean basically
`2 you had a version of them and looked at it,
`3 checked it over outside of kind of the operating
`4 context?
`5 A. Yes. In more of a -- like an R&D lab-type
`6 setting.
`7 Q. And you note that you've performed testing on
`8 the GuideLiner, QXM, and Medtronic guide extension
`9 catheters.
`10 Do you see that?
`11 A. Yes.
`12 Q. What testing did you do on GuideLiner?
`13 A. On GuideLiner, I -- in addition to my visual
`14 inspections, I did some flexibility
`15 characterizations, some bending, stiffness
`16 characterizations on different portions of the
`17 device.
`18 Q. Any other testing besides bending and
`19 stiffness testing?
`20 A. I don't recall any others sitting here right
`21 now.
`22 Q. Okay. And then how about same question for
`23 the QXM Boosting Catheter; what testing did you do
`24 on that?
`25 A. I did similar types of testing on that
`
`Page 7
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`Page 9
`
`1 through some of the other exhibits and prior art
`2 as we go through the day.
`3 So looking at that declaration, you
`4 note in paragraph 18 that you have inspected the
`5 GuideLiner devices, Boston Scientific Guidezilla,
`6 QXM Boosting Catheter, and the Medtronic Telescope
`7 guide extension catheter.
`8 Do you see that?
`9 A. Yes.
`10 Q. And in addition to inspecting, you said you
`11 performed testing?
`12 A. Correct.
`13 Q. Okay. So first, is it true you haven't
`14 actually used any of those devices to perform a
`15 procedure on a patient, correct?
`16 A. That's correct.
`17 Q. Have you witnessed any procedures using those
`18 devices?
`19 A. I have not witnessed any in person. I -- you
`20 know, over the course of the years, I may have
`21 seen some video snippets or certainly, you know,
`22 read some references related to the use of these
`23 devices, but I have not seen a device used in
`24 person.
`25 Q. Okay. So for this case, when you say you
`
`1 device, and I think I also did some dimensional
`2 measurements. I think I -- yeah, that's --
`3 sitting here right now, those are the types of
`4 tests that I recall doing on that device.
`5 Q. All right. And finally, for the Medtronic
`6 Telescope guide extension catheters, what testing
`7 did you perform?
`8 A. Again, similar types of flexibility testing
`9 that I did on the other devices.
`10 Q. All right. Do you have, in your history or
`11 experience, any experience as a librarian?
`12 A. No.
`13 Q. Have you ever worked as an editor of an
`14 engineering journal?
`15 A. No.
`16 Q. All right. Let's jump ahead.
`17 You get into your declaration in,
`18 say, paragraph 38. You're going through a lot of
`19 background and teaching, and here you're teaching
`20 about the use of balloons and stents.
`21 Do you see that?
`22 A. Yes.
`23 Q. And can you tell me -- and take yourself back
`24 into the 1990s -- how does a stent operate? What
`25 is its function? How does it work?
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`1 A. I think I outlined it pretty well in my
`2 report. I'm not sure -- you want me to add more
`3 to that or -- I guess I'm not quite sure what
`4 you're asking. I mean, at a high level, they're
`5 devices that are implanted into blood vessels to
`6 dilate and maintain a dilation of a blockage.
`7 Q. Okay. So does the stent dilate the vessel?
`8 A. Typically the stents are mounted on a balloon
`9 catheter, and it's the combination of the stent on
`10 the balloon that's inflated to dilate the lesion.
`11 Q. I think you said the stent is there to
`12 maintain that dilation; is that correct?
`13 A. Yeah. The stent is something that's left
`14 behind as an implant in the patient.
`15 Q. And does it have to then basically press out
`16 against the artery that it's in, or how much force
`17 does it have to apply to maintain that dilation?
`18 A. It's really a function of what -- how much
`19 resistance the dilated lesion is presenting back
`20 onto the stent, so it could be different depending
`21 on the patient's anatomy.
`22 Q. All right. So -- but the stent is designed
`23 to withstand whatever it needs to in order to
`24 maintain that dilation, right?
`25 A. I would say for the most part, yes.
`
`Page 11
`
`1 Q. If you want to follow along in your
`2 declaration, you get to paragraph 57 and you're
`3 now talking about -- you say, "Numerous variables
`4 can impact how easy or difficult it is to treat a
`5 particular patient lesion."
`6 Do you see that?
`7 A. Yes.
`8 Q. Okay. Can you list all the variables you can
`9 think of, please?
`10 A. I -- again, at a high level, I think the
`11 variables that can impact that are the nature of
`12 the lesion itself, the tightness of the lesion.
`13 Is it heavily calcified? Where is it located? Is
`14 it in tortuous anatomy? Is there tortuous anatomy
`15 leading up to it? Is it, you know, in a vein
`16 graft versus in a native coronary artery?
`17 Those are some of the variables that
`18 I can think of sitting here right now.
`19 Q. All right. Let's go down on one of them.
`20 Let's go with a tighter lesion. And I know you
`21 talk about that here, and you say, "tighter lesion
`22 will require a higher advancement force."
`23 Do you see that about halfway down
`24 that paragraph?
`25 A. Yes.
`
`1 Q. So what is a normal advancement for?
`2 A. I'm not sure I understand the question. What
`3 I said here is that -- I think I'm describing sort
`4 of a relative comparison. If it's a tighter
`5 lesion versus one that's not as tight; you may
`6 have to push harder to get across that lesion.
`7 Q. Right. But from an engineering standpoint,
`8 is that something that can be measured, that you
`9 can talk about whether a normal advancement force
`10 versus a higher advancement force?
`11 A. I think it can be measured. I don't have
`12 those numbers in my head right now.
`13 Q. So when you say "higher," do you have any way
`14 to quantify this or give me any idea of what
`15 you're talking about in terms of a higher
`16 advancement force?
`17 A. Sitting here right now, I can't really
`18 quantify that, but I think it's -- I think one
`19 could measure that in different types of lesions.
`20 Q. How would you measure it?
`21 A. Again, I mean, I haven't thought about it. I
`22 don't know exactly how you'd measure it. But, you
`23 know, I think it would be possible to measure --
`24 with a force gauge measure, you know, an
`25 advancement force on the proximal end of the
`
`Page 13
`1 device. You could measure a force being applied
`2 to a lesion if you were doing more of a bench-type
`3 test. I think there are ways that it could be
`4 done, but, again, I haven't given that a whole lot
`5 of thought.
`6 Q. Have you ever done that in your long history
`7 of working on catheters and catheter design?
`8 A. I may have. I don't recall specifically.
`9 Q. And you talk about here the reactive force
`10 for the end, right, and it could cause a guide
`11 catheter to back out.
`12 Do you see that?
`13 A. Yes.
`14 Q. So for that reactive force, again, is there
`15 any way to quantify that for me or tell me how
`16 much force will be required to make the guide
`17 catheter back out?
`18 A. Again, I mean, I think it would depend on
`19 different factors, but for a given situation, I
`20 think that is something that could possibly be
`21 measured. I wouldn't know exactly how to do that
`22 just off the top of my head.
`23 Q. Okay. And so is there sort of a range of
`24 forces that might cause it to back out?
`25 A. There probably is, but I don't know exactly
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`1 what those would be.
`2 Q. You don't know what the minimum force would
`3 be required to cause it to back out, right?
`4 A. Well, again, it would depend on other factors
`5 too. It could depend on the guide catheter
`6 itself, the anatomy. But for a given scenario, I
`7 think that's something that could be measured.
`8 Q. Okay. And how could it depend on the guide
`9 catheter?
`10 A. Shape, size, construction. Those things can
`11 influence how much -- how easily a guide catheter
`12 could back up -- back out. Sorry.
`13 Q. Okay. And how about the anatomy you said?
`14 How could that impact how much a reactive force is
`15 required to have it back out?
`16 A. Some things I think would be the size of the
`17 aorta, how the guide catheter is positioned within
`18 the aorta relative to the -- to the coronary
`19 artery. Those are a couple examples.
`20 Q. Okay. And are there any other factors
`21 besides the structure or whatever of the guide
`22 catheter and the patient anatomy that can affect
`23 the amount of reactive force required for the
`24 guide catheter to back out?
`25 A. There may be. I can't think of any right
`
`Page 16
`1 know, the guide catheter itself, the construction
`2 details, how far it's being deep-seated.
`3 Those are some of the variables that
`4 could affect that if you were to deep seat a guide
`5 catheter.
`6 Q. All right. And how about another thing that
`7 you discuss in here, the mother and child
`8 arrangement for addressing backup support like the
`9 Shockey patent you discuss. In the mother and
`10 child context, do you have any idea how much extra
`11 force can be applied?
`12 A. I don't have a specific number for that.
`13 And, again, I think it would depend on some
`14 variables of what that mother and child
`15 arrangement is.
`16 Q. Again, in the mother and child context, you
`17 could measure how much extra backup support that's
`18 giving, but that's not something you've done for
`19 this case, right?
`20 A. I think it is something that could be
`21 measured. I have not specifically done that.
`22 Q. Okay. Paragraph 61, your -- again, here
`23 you're talking about teaching mother and child was
`24 known prior to May 2006 to provide backup support;
`25 is that right?
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`Page 15
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`Page 17
`
`1 now.
`2 Q. Okay. And, again, this reactive force, this
`3 is something that you could measure, but you
`4 haven't done that for this case; is that right?
`5 A. Not specifically. Correct.
`6 Q. Let's talk about some of the other things
`7 that were done to address this backout problem.
`8 How well does deep-seating work in
`9 terms of preventing backout?
`10 A. I believe that it works to some extent. It's
`11 just a very risky thing to consider, so it's --
`12 it's -- I think it tends to be rarely employed
`13 because of the concerns that can come about by
`14 deep seating a conventional guide catheter into a
`15 patient.
`16 Q. Sure. And I'm aware of the concerns to the
`17 anatomy. I want to focus just on how much
`18 additional backup support, if you will, can be
`19 offered by deep-seating.
`20 Do you know that in any kind of
`21 qualitative or quantitative sense, how much extra
`22 force can be applied to crossing a lesion if the
`23 guide catheter is deep-seated?
`24 A. I don't. Again, I think that also would
`25 depend on some different variables, like, you
`
`1 A. Correct.
`2 Q. And, in fact, mother and child was known to
`3 provide increased backup support for, like, a
`4 decade or more prior to May 2006, right?
`5 A. I don't know how long it was known.
`6 Q. You don't know when the earliest mother and
`7 child catheters were?
`8 A. Sitting here right now, I don't recall that.
`9 Q. In paragraph 62 of your declaration, you say,
`10 "The Shockey patent was 1991."
`11 Does that refresh your recollection
`12 that it's been more than a decade of mother and
`13 child known to provide backup support prior to
`14 2005, 2006 time frame?
`15 A. Yes. So that particular reference is from
`16 1991.
`17 Q. Let's go back to your example in paragraph 61
`18 that you give.
`19 You say the child catheter is more
`20 flexible than the larger diameter guide catheter,
`21 right?
`22 A. I believe so.
`23 Q. Well, what materials is the child catheter
`24 typically made of?
`25 A. It would depend on what child catheter you're
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`1 talking about.
`2 Q. Do you know for this example you give here in
`3 paragraph 61?
`4 A. I'm not sure I do know that.
`5 Q. Is it important for the material in the child
`6 catheter to be more flexible than the mother guide
`7 catheter in order to prevent damage to the
`8 vascular?
`9 A. I -- I think it typically would be in a
`10 variety of examples of that, but whether that's
`11 crucial, I don't know.
`12 Q. Is there any limit to how flexible the child
`13 catheter should be?
`14 A. I think it's -- yeah, there's a point where
`15 if it's not flexible enough, I don't think it's
`16 going to provide meaningful backup support --
`17 Q. Okay. So if I understand your testimony
`18 there correctly, it's all going to provide some
`19 backup support, but if it gets too flexible, it
`20 won't provide what you call meaningful backup
`21 support?
`22 A. -- yeah, or it could be trivial.
`23 Q. How much backup support is meaningful backup
`24 support?
`25 A. I -- I don't have a specific number for that.
`
`1 A. Yes.
`2 Q. And so that's your testimony, correct, that
`3 you could advance various stent delivery catheters
`4 or other catheter devices through your example of
`5 a 4 French child guiding catheter?
`6 A. No. This example is not meant to be an all
`7 inclusive example of mother and child. This is an
`8 image that happens to show a 4 French catheter.
`9 And it's really for illustrative
`10 purposes of showing that it's one inside the other
`11 and that they're full-length devices.
`12 In my last sentence there, if the
`13 child catheter is big enough, it certainly could
`14 be used to deliver stents. If it's not big
`15 enough, it might not be able to deliver stents,
`16 but it might be able to deliver other catheter
`17 devices.
`18 Q. Okay. So the example that you give in your
`19 declaration, is it big enough?
`20 A. I don't know. I think it quite possibly is
`21 not, but I don't know.
`22 Q. Do you know if the inner diameter of a 4
`23 French child catheter is?
`24 A. In this example, I don't know what that is.
`25 Q. Do you know what the -- do you know if there
`
`Page 19
`1 Q. Okay. You can't quantify what is more
`2 than -- what is meaningful or more than trivial
`3 backup support?
`4 A. I don't -- I didn't say that it couldn't be
`5 quantified, but I don't have that number.
`6 Q. Okay. So it could be quantified, but you're
`7 not able to do that here today in your deposition?
`8 A. Right here right now, that's correct.
`9 Q. Okay. And this example in paragraph 61 is a
`10 4 French child catheter, right?
`11 A. That's what's shown in the image, correct.
`12 Q. And you say at the end of the paragraph that
`13 a stent could be delivered through this 4 French
`14 child catheter, right?
`15 A. I don't know if I say that. I mean, if it's
`16 going to be used to deliver a stent, it would need
`17 to be big enough to deliver a stent.
`18 Q. So your last paragraph of -- or excuse me --
`19 your last sentence of paragraph 61 says, "It
`20 should be noted that while the child catheter has
`21 a smaller diameter than the larger guide catheter,
`22 its inner diameter is still large enough to allow
`23 various stent delivery catheters or other catheter
`24 devices to be advanced within it."
`25 Do you see that?
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`Page 21
`
`1 were -- as of 2005, 2006, were there, in your
`2 words, various stent delivery catheters or other
`3 catheter devices that could be advanced through 4
`4 French child guided catheter?
`5 A. I think there -- I think there could be other
`6 catheter devices that would be relatively small
`7 that could fit through that, but I don't
`8 necessarily think a stent would fit through that,
`9 any stent. It's pretty small.
`10 Q. So this is your example, 4 French child
`11 guided catheter.
`12 As of 2005, what devices would fit
`13 through it?
`14 A. I think a -- again, the -- my last sentence
`15 there I think is trying to describe the general
`16 concept of mother and child.
`17 And it's not specifically reflective
`18 of this one example, but I think in this one
`19 example, I think probably a guidewire would go
`20 through there.
`21 Q. Okay. As of 2005, what other devices besides
`22 a guidewire would fit through a 4 French child
`23 catheter?
`24 A. You said the GuideLiner.
`25 Q. I said "guidewire."
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`1 A. I thought I heard GuideLiner. I'm sorry.
`2 I'm not sure.
`3 Q. You can't say one way or another what other
`4 devices would fit through?
`5 A. Correct.
`6 Q. If you did know the inner diameter of that 4
`7 French child catheter, then could you figure out
`8 what devices would fit through?
`9 A. That wouldn't necessarily tell me for sure
`10 which devices would fit through. I think a
`11 guidewire is pretty small, and this is a
`12 full-length device where you've got access to
`13 place and position the guidewire into the proximal
`14 end under direct visualization, so I would be
`15 pretty confident that a guidewire is going to go
`16 through there.
`17 But beyond that, I -- it's hard for
`18 me to say without actually seeing this specific
`19 device.
`20 Q. Well, as you teach this principle in your
`21 paragraph, you just say of the child catheter, its
`22 inner diameter is still large enough to allow
`23 various devices to be advanced through it.
`24 Do you see that language?
`25 A. Yes.
`
`1 coaxial arrangement.
`2 Q. Okay. And were -- I mean, was it common
`3 prior to 2005 to use, in addition to this 4 and 6
`4 example, say a 5 and 7 or a 6 and 8?
`5 Was that well known and understood?
`6 A. I'm not sure. I -- there's another
`7 reference, I believe it's at Takahashi, that talks
`8 about a 5 in 6 example.
`9 So, you know, at some point that was
`10 known, but I don't know about the other examples
`11 that you're talking about.
`12 Q. All right. Let's jump ahead to paragraph 64,
`13 and I'm just kind of giving you that for context
`14 so it will be in the right section of your
`15 declaration for my question.
`16 But you talk a lot in here about --
`17 there's over-the-wire techniques and rapid
`18 exchange techniques, right?
`19 A. Sure.
`20 Q. And over-the-wire was common by the early
`21 '90s, wasn't it?
`22 A. In what context? I mean, what --
`23 Q. As a concept for catheters.
`24 A. For balloon angioplasty catheters and stent
`25 delivery catheters, I would say that was pretty
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`1 Q. So if you know -- if the inner diameter is
`2 large enough, the devices are small enough, you
`3 know they'll fit through, right?
`4 A. No, not necessarily. If the inner diameter
`5 is smaller than the device, I think you'd be
`6 hard-pressed to get a device into that.
`7 So it, at least, needs to be large
`8 enough. But, again, depending on the device --
`9 the devices that you're talking about, that may
`10 not be the only consideration.
`11 And, again, in a mother and child
`12 situation, your ability to get certain devices in,
`13 I think, is -- I mean, you're able to put them in
`14 right there outside the patient into that lumen.
`15 So, you know -- but ultimately I
`16 don't know beyond a guidewire which other types of
`17 devices would fit into this particular example of
`18 a mother and child.
`19 Q. Okay. This particular example is a 4 French
`20 child catheter and a 6 French mother, correct?
`21 A. Yes, that's what's shown.
`22 Q. And I think we covered this yesterday, but
`23 that is a coaxial arrangement, right?
`24 A. I haven't made a specific opinion on that,
`25 but I think that's -- it very well could be a
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`1 common, that those catheters were -- had full
`2 length guidewire lumens that ran for the full
`3 length of the catheter.
`4 Q. Okay. So, again, this was at least by the
`5 early '90s, I think you said, balloon angioplasty
`6 catheters and stent delivery catheters were
`7 commonly used in an over-the-wire manner, right?
`8 A. Yes. I mean, the word "commonly," I just
`9 want to qualify a little bit. I mean, stents -- I
`10 don't have these exact dates in terms of the early
`11 '90s off the top of my head. I mean, at some
`12 point stents and stent delivery catheters, you
`13 know, continued to be more common as part of
`14 interventional cardiology procedures through the
`15 '90s. You know, at what point were they common?
`16 They certainly were out there in the early '90s,
`17 on the stent side. On the balloon angioplasty,
`18 absolutely.
`19 Q. Got it. So I think I understand. But those
`20 two were definitely known. Were there any other
`21 types of over-the-wire devices or technique
`22 besides the two you listed?
`23 A. Those are the ones I can think of. I can't
`24 think of any others sitting here right now.
`25 Q. All right. And then how about the concept of
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`1 rapid exchange? Where did that show up first?
`2 A. Well, so rapid exchange in the context of,
`3 you know, cardiology procedures really showed up
`4 in the balloon angioplasty catheter-type devices
`5 that made use of the short guidewire lumen. And
`6 there's a couple of early patents and early
`7 devices that had those shorter guidewire lumens.
`8 One of the devices is described in the Bonzel
`9 patent.
`10 Q. Okay. Is it fair to say the rapid exchange
`11 technology replaced the over-the-wire for balloon
`12 angioplasty over time?
`13 A. No, it didn't replace it. It became more
`14 common and more popular, but I think even to this
`15 day there's still some usage of over-the-wire
`16 balloon angioplasty and stent delivery catheters.
`17 Q. Okay. At least fair to say there's a lot
`18 more use of the rapid exchange version once
`19 that -- once that came out and became popularized?
`20 A. Yeah. I wouldn't say that it immediately
`21 skyrocketed, but over time, it definitely became
`22 more common, more popular.
`23 Q. And how about the over-the-wire stent
`24 delivery catheters; did that also go to a rapid
`25 exchange version?
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`1 A. Well, you're comparing over-the-wire stent
`2 delivery catheters versus rapid exchange stent
`3 delivery catheters?
`4 Q. That's my question. Did the rapid exchange
`5 have an impact on there as well?
`6 A. Yes. There are, over time, more stent
`7 delivery catheters that have been rapid
`8 exchange -- of a rapid exchange design.
`9 Q. Real basic question, I guess. For both of
`10 these things you mentioned balloon angioplasty and
`11 stent delivery catheters. Is backup support an
`12 issue or a concern with these two things?
`13 A. Is your question is backup support a concern
`14 when you're using those types of products?
`15 Q. Yes.
`16 A. Yes, it certainly can be.
`17 Q. Okay. And so when those migrated from
`18 over-the-wire to rapid exchange, was there any
`19 change in the backup support that they provided?
`20 A. Well, they don't provide backup support.
`21 Q. Yeah. It's a poor question.
`22 I guess I should say, is there any
`23 change in the backup support issue that we just
`24 talked about? Did that change at all moving from
`25 the over-the-wire version to the rapid exchange
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`1 version?
`2 A. I'm not sure if that changed the issues
`3 around backup support.
`4 Q. If we jump ahead to paragraph 75 of your
`5 declaration, do you see here you're talking about
`6 the Ressemann prior art reference that's at issue
`7 in these IPRs?
`8 A. Yes.
`9 Q. And we talked about, somewhat yesterday, your
`10 relationship to Mr. Ressemann. Are you familiar,
`11 based on that, with this product you have here,
`12 the Ressemann product called Proxis?
`13 A. Yes, I do have familiarity with that.
`14 Q. Is this something that you worked on, this
`15 Proxis product, or consulted on?
`16 A. I did. I was involved in this project early
`17 on in the conceptual phase, and then we hired on
`18 engineers over time, and so my day-to-day
`19 involvement became less over time. But, you know,
`20 it's a small company, so still pretty familiar
`21 with what everybody is working on.
`22 Q. Okay. So the Ressemann prior art reference
`23 we talked about, that discloses a rapid exchange
`24 device, right?
`25 A. It discloses a device with a -- I mean, it
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`1 discloses a device with an evacuation lumen
`2 that's -- there's embodiments where that's
`3 relatively short compared to -- I think there are
`4 embodiments where that evacuation lumen is a full
`5 length through the device.
`6 Q. Right. But it includes and discloses
`7 basically a rapid exchange version, right?
`8 A. Yeah. I mean, if you're using rapid exchange
`9 in the context of that it's got a shorter lumen,
`10 then yes.
`11 Q. Yes. And I was trying to use it in the same
`12 context as we talked about earlier.
`13 So the Ressemann product you note
`14 here is not a rapid exchange version. It's a --
`15 basically a mother and child, right?
`16 A. Yeah, in the sense that it's got a
`17 full-length lumen.
`18 Q. Okay. When bringing this product to market,
`19 why didn't you guys -- why didn't Mr. Ressemann
`20 bring forward the rapid exchange version?
`21 A. There were some -- I mean, I -- you know,
`22 there were a lot of engineering decisions and, you
`23 know, feedback from physicians and whatnot that
`24 would have been part of that project, and it
`25 ultimately was determined that this was a better,
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`1 simpler approach.
`2 Q. Okay. Do you remember any specifics as to
`3 why it was better or simpler to go with the mother
`4 and child than with the rapid exchange version?
`5 A. I -- again, I wasn't that involved day to day
`6 when a lot of those decisions were being made, so
`7 I -- I really can't speak to those specific
`8 reasons.
`9 Q. All right. So, certainly, from a --
`10 technologically, from an engineering standpoint,
`11 you could have designed and come forward with a
`12 rapid exchange version of Ressemann and the Proxis
`13 device, right?
`14 A. Well, it wasn't commercialized, so I don't
`15 know that I would agree with that. It certainly
`16 was possible to design and build prototypes of
`17 something like that, but as I describe here, that
`18 was not commercialized. So, you know, I don't
`19 know that it -- it could have been a futile thing
`20 to try to commercialize that for whatever the
`21 reasons were that -- that it wasn't
`22 commercialized.
`23 Q. But you don't think you could have just cut
`24 the tube shorter and added a push rod instead to
`25 make it rapid exchange, as an engineer?
`
`1 development projects are all about.
`2 You know, it's -- you can conceive
`3 of something, but to actually build it and do all
`4 the testing and prove that it works and then
`5 commercialize it may -- it's more complicated than
`6 that to commercialize a product based on a
`7 simpl