UNITED STATES DISTRICT COURT
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` FOR THE DISTRICT OF MINNESOTA
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`Page 1
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` VASCULAR SOLUTIONS, LLC,
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` TELEFLEX INNOVATIONS, S.à r.l.,
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` ARROW INTERNATIONAL, INC.,
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` and TELEFLEX, LLC,
`
` Plaintiffs,
`
` vs. No. 0:19-cv-01760-PJS-TNL
`
` MEDTRONIC, INC., and
`
` MEDTRONIC VASCULAR, INC.,
`
` Defendants.
`
` ------------------------------------------------
`
` VIDEO EXPERT DEPOSITION TESTIMONY OF
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` PETER T. KEITH
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` WEDNESDAY, OCTOBER 16, 2019
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` MINNEAPOLIS, MINNESOTA
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`1 APPEARANCES (continued):
`2 FREDRIKSON & BYRON, P.A.
`3 BY: KURT J. NIEDERLUECKE, ESQUIRE
`4 kniederluecke@fredlaw.com
`5 LAURA L. MYERS, ESQUIRE
`6 lmyers@fredlaw.com
`7 Suite 4000
`8 200 South Sixth Street
`9 Minneapolis, Minnesota 55402
`10 612.492.7000
`11 Counsel for Defendants
`12
`13 ROBINS KAPLAN, LLP
`14 BY: CYRUS A. MORTON, ESQUIRE
`15 cmorton@robinskaplan.com
`16 Suite 2800
`17 800 LaSalle Avenue
`18 Minneapolis, Minnesota 55402
`19 612.349.8722
`20 Counsel for Defendants
`21 Also Present:
`22 Greg Smock, Vascular Solutions, Inc.
`23 * * *
`24
`25
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`1 * * *
`
`2 3
`
` Video Expert Deposition Testimony of
`4 PETER T. KEITH taken at the law offices of
`5 Fredrikson & Byron, P.A., Suite 4000, 200 South
`6 Sixth Street, Minneapolis, Minnesota on
`7 Wednesday, October 16, 2019, commencing at 9:00
`8 a.m. before Rebecca L. Klanderud, a Certified
`9 Shorthand Reporter.
`10
`11
`12
`13
`14 * * *
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
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`Page 3
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`1 APPEARANCES:
`2 CARLSON, CASPERS, VANDENBURGH,
`3 LINDQUIST & SCHUMAN, P.A.
`4 BY: JOSEPH W. WINKELS, ESQUIRE
`5 jwinkels@carlsoncaspers.com
`6 J. DEREK VANDENBURGH, ESQUIRE
`7 dvandenburgh@carlsoncaspers.com
`8 Suite 4200
`9 225 South Sixth Street
`10 Minneapolis, Minnesota 55402
`11 612.436.9600
`12 Counsel for Plaintiffs
`13
`14 DORSEY & WHITNEY, LLP
`15 BY: KENNETH E. LEVITT, ESQUIRE
`16 levitt.kenneth@dorsey.com
`17 Suite 1500
`18 50 South Sixth Street
`19 Minneapolis, Minnesota 55402
`20 612.340.2755
`21 Counsel for Plaintiffs
`22
`23
`24
`25
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`1 INDEX:
`2 EXAMINATION: PAGE
`3 By Mr. Niederluecke . . . . . . . . . . . 9, 291
`4 By Mr. Winkels. . . . . . . . . . . . . . 286
`5 * * *
`6 EXHIBITS:
`7 MEDTRONIC EXHIBITS: PAGE MARKED
`8 Exhibit 1 United States Patent No.
`9 US 8,048,032 B2, Root, et al. 8
`10 Exhibit 2 United States Reissued Patent No.
`11 US RE45,380 E, Root, et al. 8
`12 Exhibit 3 United States Reissued Patent No.
`13 US RE45,776 E, Root, et al. 8
`14 Exhibit 4 United States Reissued Patent No.
`15 US RE47,379 E, Root, et al. 8
`16 Exhibit 5 United States Reissued Patent No.
`17 US RE45,760 E, Root, et al. 8
`18 Exhibit 6 Declaration of Peter Keith in
`19 Support of Plaintiffs' Motion for
`20 Preliminary Injunction 12
`21 Exhibit 7 Teleflex GuideLiner V3 Catheter
`22 product brochure 14
`23 Exhibit 8 Curriculum Vitae of Peter T.
`24 Keith, also marked Exhibit Q
`25 to his declaration 18
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`1 EXHIBITS (continued):
`2 MEDTRONIC EXHIBITS: PAGE MARKED
`3 Exhibit 9 Article by Takahashi, et al.
`4 entitled: "New Method to Increase
`5 a Backup Support of Six French
`6 Guiding Coronary Catheter." 50
`7 Exhibit 10 Medtronic Telescope Guide
`8 Extension Catheter - Retained by
`9 Counsel, Mr. Niederluecke 91
`10 Exhibit 11 Claim chart for U.S. Patent No.
`11 RE45,380, also marked as
`12 Exhibit M to Mr. Keith's
`13 declaration 96
`14 Exhibit 12 Claim chart for U.S. Patent No.
`15 RE45,776, also marked as
`16 Exhibit N to Mr. Keith's
`17 declaration 143
`18 Exhibit 13 Claim chart for U.S. Patent No.
`19 RE47,379, also marked as
`20 Exhibit O to Mr. Keith's
`21 declaration 174
`22 Exhibit 14 Order in the QXMédical vs.
`23 Vascular Solutions, LLC, et al.
`24 case, dated 10/2/19 187
`25
`
`1 * * *
`2 (Whereupon, Deposition Exhibits 1
`3 through 5 were marked for
`4 identification.)
`5 * * *
`6 THE VIDEO TECHNICIAN: We are going
`7 on the record at 9:02 a.m.
`8 Today's date is October 16th, 2019.
`9 This is media unit one of the video-recorded
`10 deposition of Peter T. Keith taken by counsel
`11 for the defendant in the matter of Vascular
`12 Solutions, LLC, et al. versus Medtronic,
`13 Incorporated, et al., filed in the United States
`14 District Court, District of Minnesota, Court
`15 File Number 0:19-CV-1760 PJS/TNL. This
`16 deposition is being held at Fredrikson & Byron
`17 in Minneapolis, Minnesota.
`18 My name is Adam Wallin from the firm
`19 Veritext, and I'm the videographer. The court
`20 reporter is Rebecca Klanderud from Veritext.
`21 Will counsel please identify
`22 themselves for the record?
`23 MR. NIEDERLUECKE: Kurt Niederluecke
`24 from Fredrikson & Byron on behalf of the
`25 Medtronic defendants.
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`1 EXHIBITS (continued):
`2 MEDTRONIC EXHIBITS: PAGE MARKED
`3 Exhibit 15 Claim chart for U.S. Patent No.
`4 RE45,760, also marked as
`5 Exhibit P to Mr. Keith's
`6 declaration 201
`7 Exhibit 16 Declaration of Peter T. Keith in
`8 Support of Defendants' Opposition
`9 to Plaintiff's Motion for Summary
`10 Judgment and Defendants'
`11 Cross-Motion for Summary Judgment
`12 in the QXMédical vs. Vascular
`13 Solutions, LLC, et al. case 215
`14 Exhibit 17 Demonstrative exhibit titled
`15 "Straw Side Views" 276
`16 * * *
`17
`18
`19
`20
`21
`22
`23
`24
`25
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`1 MS. MYERS: Laura Myers from
`2 Fredrikson & Byron also on behalf of Medtronic
`3 defendants.
`4 MR. MORTON: This is Cyrus Morton
`5 from Robins Kaplan. I also represent Medtronic.
`6 MR. WINKELS: On behalf of the
`7 plaintiffs, Joe Winkels and Derek Vandenburgh
`8 with Carlson Caspers. And we've got Ken Levitt
`9 with the Dorsey Firm and Greg Smock.
`10 THE VIDEO TECHNICIAN: Will the court
`11 reporter please swear in the witness?
`12 * * *
`13 PETER T. KEITH,
`14 a witness in the above-entitled matter,
`15 having been first duly sworn,
`16 testified on his oath as follows:
`17 * * *
`18 EXAMINATION
`19 * * *
`20 BY MR. NIEDERLUECKE:
`21 Q. Good morning, Mr. Keith.
`22 A. Good morning.
`23 Q. Mr. Keith, I understand that you are
`24 here today in your capacity as an expert witness
`25 in this case; is that correct?
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`1 A. Yes.
`2 Q. And who are you retained by?
`3 A. Uh, by, uh, the plaintiffs.
`4 Q. Okay. The plaintiffs are the group I
`5 presume?
`6 A. Yes.
`7 Q. Okay. Mr. Keith, I'm going to hand
`8 you what's been marked as Medtronic Exhibits 1
`9 through 5.
`10 MR. NIEDERLUECKE: And for record,
`11 Exhibit 1 is U.S. Patent 8,048,032; Exhibit 2 is
`12 U.S. Reissued 45,380; Exhibit 3 is U.S. Reissued
`13 45,776; Exhibit 4 is U.S. Reissue 47,379, and
`14 Exhibit Number 5 is U.S. Reissue 45,760.
`15 BY MR. NIEDERLUECKE:
`16 Q. And did I -- did I read those
`17 accurately?
`18 A. I think so, yes.
`19 Q. Okay. And, um, does it appear to you
`20 that those are the patents related to this
`21 matter?
`22 A. Um, yes.
`23 Q. And those are the, to your
`24 understanding, the five patents that the
`25 plaintiffs have asserted that Medtronic is
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`Page 12
`1 some information in my report on that. I don't
`2 recall it exactly right now --
`3 Q. Okay.
`4 A. -- but I did bring a copy of my
`5 report (witness indicating).
`6 Q. And I will mark it, and you're
`7 welcome if -- if you feel the need to look at
`8 it.
`9 A. Yeah, I mean because that might
`10 clarify that. I'm not sure --
`11 Q. Sure.
`12 A. -- if it does exactly but --
`13 Q. Okay. Why don't we go ahead. In
`14 fact, I've got a copy of your report right here.
`15 MR. NIEDERLUECKE: Why don't we mark
`16 that as Exhibit 6?
`17 * * *
`18 (Whereupon, Deposition Exhibit 6 was
`19 marked for identification.)
`20 * * *
`21 MR. WINKELS: And just for the
`22 record, so Exhibit 6 does not include the
`23 exhibits, right?
`24 MR. NIEDERLUECKE: Yes.
`25 BY MR. NIEDERLUECKE:
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`Page 13
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`1 infringing?
`2 A. Yes.
`3 Q. Who owns the -- and I'll -- if you
`4 don't mind, I'll refer to those as the
`5 patents-in-suit, okay?
`6 A. Yes.
`7 Q. Who do you understand owns the
`8 patents-in-suit?
`9 A. I believe they're owned by Vascular
`10 Solutions.
`11 Q. So you think Vascular Solutions, the
`12 company, owns them?
`13 A. Well, and I -- I mean Vascular
`14 Solutions is part of Teleflex Medical, so --
`15 Q. And so what I'm asking is who -- do
`16 you understand what entity actually owns the
`17 patents?
`18 A. I guess I don't know for sure.
`19 Q. Okay. Do you know what entity has
`20 the exclusive rights in the patent?
`21 A. Um, I'm not sure.
`22 Q. Okay. Do you know what entity has
`23 the exclusive rights to sell products under
`24 these patents?
`25 A. Well, I do -- there -- there may be
`
`1 Q. This is -- this is your report, and
`2 I'll mark different exhibits individually, but
`3 this is for the record your report without the
`4 attached exhibits.
`5 A. Okay.
`6 Q. If you just take a look and confirm
`7 for us that Exhibit 6 is -- is indeed the report
`8 that you submitted and signed on October 10th,
`9 2019?
`10 A. Yes. It appears to be.
`11 Q. Okay. And -- and you provided this
`12 report in support of the plaintiffs' Motion For
`13 Preliminary Injunction; is that correct?
`14 A. Yes.
`15 Q. And so, um, I think we were asking
`16 the question about the exclusive rights to sell
`17 under the patent, and I asked you whether you
`18 were aware what entity holds the exclusive
`19 rights to sell under the patent, um, and I think
`20 you suggested you would like to look -- take a
`21 look at your report in case that would refresh,
`22 um --
`23 A. Correct.
`24 Q. -- your recollection.
`25 A. Okay. I am not seeing anything that
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`1 helps to clarify that --
`2 Q. Okay.
`3 A. -- in this report.
`4 Q. So as you testify today, you don't
`5 know who has the exclusive rights to sell under
`6 the patents-in-suit, correct?
`7 A. Correct.
`8 Q. Do you know what entity actually
`9 sells the GuideLiner -- your -- let me step
`10 back.
`11 You're familiar with a product called
`12 the GuideLiner?
`13 A. Yes.
`14 Q. Um, and the GuideLiner has had
`15 different versions, V1 through V3.
`16 Is that right?
`17 A. Yes.
`18 Q. Okay. Do you know who actually
`19 currently sells the GuideLiner V3 catheter?
`20 A. I believe it's Vascular Solutions.
`21 MR. NIEDERLUECKE: Can we have this
`22 marked?
`23 * * *
`24 (Whereupon, Deposition Exhibit 7 was
`25 marked for identification.)
`
`1 Teleflex owns Vascular Solutions?
`2 A. I -- that's my guess. Again, I don't
`3 know the exact arrangement as far as the
`4 corporate relationships go (witness indicating).
`5 Q. I'm going to hand you what's been
`6 marked as Medtronic Exhibit Number 7.
`7 Can you take a look at that and --
`8 and tell me if you recognize this document?
`9 A. I don't think I've seen this
`10 document.
`11 Q. Does it appear to you to be a
`12 brochure for the GuideLiner V3 catheter?
`13 A. It does appear to be that, yes.
`14 Q. And on the front page, um, what
`15 entity do you see or -- or what name do you see
`16 as a -- as a tradename on the document?
`17 A. Uh, Teleflex.
`18 Q. And on this document, can you take a
`19 look at it and see if you see Vascular Solutions
`20 identified anywhere in this brochure?
`21 A. Um, I do not see it.
`22 Q. So at least based on this Exhibit 7,
`23 which appears to be a brochure for the
`24 GuideLiner V3, it appears that Teleflex and not
`25 VSI is selling the GuideLiner V3 catheter,
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`1 * * *
`2 MR. NIEDERLUECKE: And -- here, hold
`3 on.
`4 BY MR. NIEDERLUECKE:
`5 Q. And what do you base your belief that
`6 Vascular Solutions sells the GuideLiner V3
`7 product?
`8 On what do you base that?
`9 A. Um, well, I -- I understand there's
`10 -- Vascular Solutions as a company, I know there
`11 was some sort of an acquisition or a corporate,
`12 um, (witness indicating) transaction with
`13 Teleflex Medical. Um, I don't know all the
`14 details of what that arrangement might be but
`15 even prior to Teleflex, when it was Vascular
`16 Solutions, and I have been involved in both this
`17 proceeding with Medtronic, as well as a
`18 proceeding with QXMédical, so I have been
`19 working with Vascular Solutions for some time,
`20 um, that I believe that it was just Vascular
`21 Solutions when I first became involved, um, but
`22 I don't know exactly what dates that the
`23 corporate transaction with Teleflex took place
`24 (witness indicating).
`25 Q. And is it your understanding that
`
`1 correct?
`2 MR. WINKELS: Objection, lack of
`3 foundation.
`4 THE WITNESS: Again, I don't
`5 understand the whole corporate relationship
`6 between Teleflex and Vascular Solutions. The
`7 document says Teleflex, um, so that's as much as
`8 I know about that.
`9 BY MR. NIEDERLUECKE:
`10 Q. Why did you choose to refer to the
`11 group of entities in this case as -- as Vascular
`12 Solutions?
`13 A. Um, again, that's -- when I became
`14 involved in this, it was Vascular Solutions.
`15 Um, that was the name on the building, um, so
`16 that's how I've referred to them and I -- I have
`17 continued to refer to them mostly as Vascular
`18 Solutions.
`19 Q. And when did you first become
`20 involved with Vascular Solutions?
`21 A. I don't recall exactly. Sometime
`22 during the QXMédical litigation.
`23 Q. Was it prior to 2019?
`24 A. Yes.
`25 Q. Was it prior to 2018?
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`1 A. Um, I'm not sure. It might have
`2 been. I don't know.
`3 Q. At the time that you were, um,
`4 retained on behalf of -- of the plaintiffs for
`5 either of these cases, um, are you aware whether
`6 the transaction with Teleflex had occurred?
`7 A. No. I don't know the time frame of
`8 that.
`9 Q. So was it your selection to refer to
`10 the plaintiffs collectively as VSI or Vascular
`11 Solutions?
`12 A. That's how I have referred to them.
`13 Q. Okay. And that's what I'm asking.
`14 In your -- in your report, when you
`15 refer to them that way, was that your choice or
`16 was that a -- was that something that you were
`17 told to do?
`18 A. Uh, I would say that was -- well, I
`19 don't know.
`20 Q. You don't know either way?
`21 A. I don't know either way.
`22 MR. NIEDERLUECKE: If I can get that
`23 marked.
`24 * * *
`25 (Whereupon, Deposition Exhibit 8 was
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`Page 20
`1 familiarity compared with what you may have
`2 seen. That's the -- that's the stamp that gets
`3 put on the document as it's filed with the
`4 District Court, and so what this is is the
`5 document as the plaintiffs' filed it with the
`6 District Court, as the District Court circulates
`7 those documents.
`8 A. Okay.
`9 Q. Now, Mr. Keith, does this lay out
`10 your relevant experience and work history?
`11 A. Yes.
`12 Q. And -- and I see as part of your work
`13 history listed under Entrepreneurial Ventures,
`14 you list Entellus Medical?
`15 A. Yes.
`16 Q. And what did -- what did you do at
`17 Entellus Medical?
`18 A. I was a cofounder and then was the,
`19 um, head of the R&D group.
`20 Q. Okay. And as that head, were you
`21 responsible for overseeing the product
`22 development on the FinESS and XprESS sinusitis
`23 treatment technologies?
`24 A. Yes.
`25 Q. And so did you help actually develop
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`1 marked for identification.)
`2 * * *
`3 BY MR. NIEDERLUECKE:
`4 Q. Mr. Keith, I'm handing you what's
`5 been marked as Medtronic Exhibit 8.
`6 Can you tell me what this document
`7 is?
`8 A. It appears to be a copy of my resume.
`9 Q. And you attached -- this is the copy
`10 Exhibit Q that you attached to -- as part of
`11 your report in this case?
`12 A. Yes, I believe so.
`13 Q. And if you look down, in the bottom
`14 right, I think you'll see there's an Exhibit Q
`15 label, which you'll see on any of the exhibits
`16 as we, um, received them.
`17 And do you see on the top, there's a
`18 -- there's a -- a line across the top that lists
`19 case information and a date?
`20 Do you see that?
`21 A. Yes.
`22 Q. Do you understand what that is?
`23 A. Uh, no.
`24 Q. Okay. I'll just inform you just as
`25 you look at the documents for your own
`
`1 and bring those products to market?
`2 A. Yes, I did.
`3 Q. As part of that, did you have to file
`4 any -- um, you being the company, did the
`5 company have to file any, um, requests for
`6 approvals from the FDA?
`7 A. For those products, yes.
`8 Q. And did you -- did -- did the company
`9 in fact file 510(k) approvals or requests for
`10 510(k) approvals?
`11 A. Yes.
`12 Q. And what do you understand is -- is a
`13 510(k) request?
`14 A. Well, I'm not a regulatory expert,
`15 but it's a -- one of the processes by which you
`16 get a product approved for sale.
`17 Q. And -- and do you know what the
`18 criteria is for -- for getting the product
`19 approved for sale through the FDA 510(k)
`20 process?
`21 A. No, not exactly.
`22 Q. Um, are you -- have you heard the
`23 term "predicate device" as part of that process?
`24 A. Yes.
`25 Q. And have you heard the term referred
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`1 to as "substantial equivalence"?
`2 A. Uh, yes, I have.
`3 Q. And is it correct that the FDA
`4 requires through the 510(k) process that -- that
`5 someone applying for a new product that doesn't
`6 want to go through full pre-market approval,
`7 would have to, um, provide representations
`8 regarding substantial equivalence to a predicate
`9 device?
`10 A. Yes, in the context of that approval
`11 process.
`12 Q. And by providing that, a device such
`13 as the XprESS and FinESS products are
`14 substantially equivalent to a -- a predicate or
`15 prior device, um, is that a representation that
`16 suggests that -- that the FinESS or XprESS
`17 products were copies of that device?
`18 A. Of that predicate device?
`19 Q. Yes.
`20 A. No.
`21 Q. In fact, did -- did -- did Entellus
`22 Medical copy the Acclarent predicate device in
`23 the time that you were working for Entellus
`24 Medical?
`25 A. No.
`
`1 Q. Entellus ended up settling that case,
`2 correct?
`3 A. Correct.
`4 Q. And it took a license to the -- the
`5 patents-in-suit?
`6 A. That's correct.
`7 Q. And even with that license, did --
`8 did -- did the license mean that Entellus was,
`9 in fact, infringing on Acclarent's patents on
`10 its predicate device?
`11 A. No.
`12 Q. Now, you have Exhibit 6. I'm going
`13 to refer you back to your report.
`14 A. Can I -- can I just go back and
`15 clarify something on that prior question?
`16 Q. Sure.
`17 A. Um, when I said "no," it -- what I
`18 was referring to was that it doesn't necessarily
`19 mean that there was infringement, um, because
`20 there was never a final determination of whether
`21 there was infringement. It was a settlement
`22 before the legal proceedings would have been
`23 finalized.
`24 Q. Okay. Thank you.
`25 So if we can turn to Exhibit 6, and
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`Page 23
`1 Q. Indeed, Acclarent filed a lawsuit
`2 against Entellus Medical over its FinESS and
`3 XprESS products, didn't it?
`4 A. Um, there was a lawsuit. I -- I
`5 don't recall all of the particulars of what was
`6 part of that lawsuit.
`7 Q. And was that while you were at
`8 Entellus?
`9 A. Yes.
`10 Q. Were Acclarent's claims that Entellus
`11 was infringing its patents based on -- that it
`12 had on its predicate device, were those claims
`13 true?
`14 A. I'm not sure I understand the
`15 question.
`16 Q. Sure. Because they filed a lawsuit
`17 claiming that the, um, Entellus products
`18 infringed Acclarent's patents on its predicate
`19 device, does that mean that it, in fact, is
`20 correct?
`21 Let me rephrase it.
`22 Do you -- do you believe that the
`23 Acclarent allegations of infringement in that
`24 case were accurate?
`25 A. No.
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`Page 25
`1 that's your declaration you've submitted in
`2 support of the motion for preliminary junction,
`3 correct?
`4 A. Yes.
`5 Q. And in your declaration, you discuss
`6 the anatomy of the heart and what you refer to
`7 as coronary arteries, correct?
`8 A. Yes.
`9 Q. And there's a left main artery and a
`10 right coronary artery that branch off from the
`11 aorta; is that correct?
`12 A. Um, yes. I think I call it out on --
`13 Q. I think around page six.
`14 A. -- page six.
`15 Q. So -- so, yes. There's the left main
`16 coronary artery and the right coronary artery
`17 that branch off from the aorta, correct?
`18 A. Correct.
`19 Q. And the openings to these arteries
`20 from the aorta are -- are called ostia.
`21 Is that right?
`22 A. Uh, yes.
`23 Q. Singular, it's ostium?
`24 A. Correct.
`25 Q. Do you consider the ostium to be a
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`7 (Pages 22 - 25)
`888-391-3376
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`Medtronic Exhibit 1077
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`1 part of and in the coronary artery?
`2 MR. WINKELS: Objection, vague.
`3 THE WITNESS: Um, well, it's the
`4 opening. I don't know that it necessarily means
`5 it's part of the coronary artery or --
`6 BY MR. NIEDERLUECKE:
`7 Q. So --
`8 A. -- part of the aorta.
`9 Q. So it's -- is it in between the
`10 coronary artery and the aorta?
`11 A. Um, well, I don't know that there's a
`12 strict definition.
`13 Q. Okay. So --
`14 A. Um, I think in -- in the context of
`15 this, I think of it as it's the opening (witness
`16 indicating).
`17 Q. And if I place a -- a catheter in the
`18 ostium or the opening of the coronary artery, is
`19 it -- is it in the coronary artery?
`20 A. It could be.
`21 Q. And it may not be?
`22 A. Again, I don't know if there's a real
`23 strict definition of that.
`24 Q. So --
`25 A. I tend to think of it as -- as the
`
`1 Q. So in -- in your understanding of the
`2 typical coronary catheter procedure, it may be
`3 within the coronary artery, or it may not be
`4 within the coronary artery, but it's going to be
`5 close?
`6 A. Correct.
`7 Q. Is there any -- is that -- is that a
`8 surgeon's preference or how -- how -- how does a
`9 surgeon decide whether to place the tip of the
`10 guide catheter within the coronary artery or
`11 just outside of it?
`12 A. It would depend on the patient's
`13 anatomy and exactly how that guide catheter ends
`14 up lining up within that anatomy --
`15 Q. So that would be a --
`16 A. -- or at different parts of the
`17 procedure. It may be within -- you know, a
`18 short distance within the coronary, or it may be
`19 a short distance outside the coronary (witness
`20 indicating).
`21 Q. So the -- so the decision on that
`22 placement is based on the surgeon's expertise
`23 and the patient's anatomy?
`24 A. Yes, but, again, even within a
`25 procedure, at times, it might be in a slightly
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`Page 27
`1 opening. So if you're beyond the opening, then
`2 you're in the coronary artery.
`3 Q. But if you're at the opening, then
`4 you're not in the coronary artery?
`5 A. I don't know.
`6 Q. And if you're short of the opening,
`7 then you're not in the coronary artery, correct?
`8 A. I would say if you're short of the
`9 opening, you're not in the coronary artery.
`10 Q. And if you're at the opening, you
`11 don't know?
`12 A. Correct.
`13 Q. Now, and I'm just kind of going
`14 through your report here, and I'll be kind of
`15 walking through some of it, so we'll try to go
`16 somewhat logically here. Um, and I know I'm on
`17 page seven with regard to my next question.
`18 So in a -- in a typical coronary
`19 catheter procedure, is the guide catheter
`20 advanced to a location where the tip is next to
`21 or just at the coronary ostium?
`22 A. The guide catheter would typically be
`23 -- it could -- it could vary a little bit. It
`24 could be right at the opening, or it could be a
`25 little bit within the coronary artery.
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`1 different place at different times of the
`2 procedure.
`3 Q. Now, guide catheters, and I'm talking
`4 just general guide catheters. Um, I'll try --
`5 I'll try to use a guide extension catheter to
`6 differentiate.
`7 So if I'm referring to guide
`8 catheter, I'm speaking just of the typical prior
`9 art guide catheters, okay?
`10 A. Okay.
`11 Q. So guide catheters typically have
`12 multiple regions of flexibility, correct?
`13 A. It could depend on the guide
`14 catheter.
`15 Q. But -- but, in general, they have
`16 multiple layers and multiple regions of
`17 flexibility, correct?
`18 A. Yes.
`19 Q. And they're typically stiffer at the
`20 proximal end and progressively more flexible
`21 towards the distal end; is that correct?
`22 A. I'm just read- --
`23 MR. WINKELS: Objection, vague.
`24 Sorry.
`25 Objection, vague.
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`8 (Pages 26 - 29)
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`Medtronic Exhibit 1077
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`1 Go ahead.
`2 THE WITNESS: I just want to refer to
`3 my report again.
`4 Um, so, yes, that's correct.
`5 BY MR. NIEDERLUECKE:
`6 Q. And when you refer to proximal end,
`7 you're referring to the end that's nearest
`8 essentially the exit of the body in which the
`9 catheter has been placed into, right?
`10 A. Correct. In this document, that's
`11 how I've used that term (witness indicating).
`12 Q. And then in terms of a -- talking
`13 about distal or distally, that would be towards
`14 the working end essentially of the catheter
`15 within the aorta or coronary artery, correct?
`16 MR. WINKELS: Objection, vague.
`17 THE WITNESS: I -- I don't know if
`18 I'd necessarily say working end in that context
`19 but it's -- if -- if the handle portion is the
`20 proximal end, then the distal portion would be
`21 moving towards the opposite end (witness
`22 indicating).
`23 BY MR. NIEDERLUECKE:
`24 Q. Okay. And that opposite end, the
`25 distal end is the end that's going into the --
`
`1 Let me clarify. They've had braids.
`2 They've had, um, polymer -- you know, a layer of
`3 polymer on the outside (witness indicating), um,
`4 so in that sense, there's multiple layers. In
`5 terms of the progression of stiffness
`6 characteristics, I don't know when that came
`7 about.
`8 Q. Certainly before the patents-in-suit
`9 in this case were applied for, correct?
`10 A. I think so.
`11 Q. And so someone of ordinary skill in
`12 the art prior to the application of
`13 patents-in-suit would have been aware of how
`14 guide catheters are designed with multiple
`15 layers and multiple regions of flexibility.
`16 Is that right?
`17 A. I think that's right for guide
`18 catheters as you're -- as we're talking about
`19 guide catheters different from guide extension
`20 catheters.
`21 Q. So then some -- so then the structure
`22 of a guide catheter being flexible at the tip
`23 and progressively more stiff as we move
`24 proximally along the device would have been
`25 something that was obvious to someone of
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`1 through the aorta and into the nea