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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)
`___________________________________________________
`
` REMOTE VIDEOTAPED DEPOSITION OF
` STEPHEN BRECKER, M.D.
`
`DATE: January 19, 2021
`TIME: 5:03 a.m. (Central)
`PLACE: Veritext Virtual Videoconference
`
`PAGES: 1 to 180
`JOB NO.: MW 4402842
`REPORTED BY: Merilee Johnson, RDR, CRR, CRC, RSA
`
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`
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`

`Page 2
`
`Page 4
`
`1 E X H I B I T S
`2 (Continued)
`3 Exhibit 1026 United States Patent No. 21
`4 5,489,278,
`5 Date of Patent: February 6, 1996
`6 Exhibit 1055 Catheterization and 111
`7 Cardiovascular Interventions,
`8 dated November 2004
`9 Exhibit 1900 Declaration of Stephen Jon David 19
`10 Brecker, MD, FRCP, FESC, FACC
`11 Submitted in Support of
`12 Petitioner's Opposition to Patent
`13 Owner's Motion to Amend,
`14 Case Nos. IPR2020-00126,
`15 IPR2020-00127,
`16 U.S. Patent No. 8,048,032
`17 Exhibit 1901 Declaration of Stephen Jon David 164
`18 Brecker, MD, FRCP, FESC, FACC
`19 Submitted in Support of
`20 Petitioner's Opposition to Patent
`21 Owner's Motion to Amend,
`22 Case Nos. IPR2020-00137,
`23 IPR2020-00138, U.S.
`24 Patent No. RE47,379
`25
`
`Page 3
`
`Page 5
`
`1 A P P E A R A N C E S
` (All appearing remotely via videoconference)
`
`23
`
`ON BEHALF OF THE PETITIONERS:
`4 ROBINS KAPLAN LLP
`BY: Sharon E. Roberg-Perez, Esq.
`5 Cyrus A. Morton, Esq.
` Ryan E. Dornberger
`6 800 LaSalle Avenue
` Suite 2800
`7 Minneapolis, Minnesota 55402
` Phone: (612) 349-8500
`8 Email: SRoberg-Perez@RobinsKaplan.com
` Email: CMorton@RobinsKaplan.com
`9 Email: RDornberger@RobinsKaplan.com
`10
`
`ON BEHALF OF THE PATENT OWNERS:
`
`11
`
`DORSEY & WHITNEY, LLP
`12 BY: Kenneth E. Levitt, Esq.
` 50 South Sixth Street
`13 Suite 1500
` Minneapolis, Minnesota 55402
`14 Phone: (612) 340-2600
` Email: Levitt.Kenneth@Dorsey.com
`
`15
`
`16
`
`-and-
`
`CARLSON, CASPERS, VANDENBURGH,
`17 LINDQUIST & SCHUMAN, PA
`BY: J. Derek Vandenburgh, Esq.
`18 225 South Sixth Street
` Suite 4200
`19 Minneapolis, Minnesota 55402
` Phone: (612) 436-9600
`20 Email: DVandenburgh@CarlsonCaspers.com
`21
`
`ALSO APPEARED:
`
`22
`
` Greg Smock (Teleflex)
`23 Peter Keith (Teleflex)
` Justin Bond (Videographer)
`
`24
`25
`
`1 I N D E X
`
`1 E X H I B I T S
`2 (Continued)
`3 Exhibit 1902 Declaration of Stephen Jon David 168
`4 Brecker, MD, FRCP, FESC, FACC
`5 Submitted in Support of
`6 Petitioner's Opposition to Patent
`7 Owner's Motion to Amend,
`8 Case Nos. IPR2020-00128,
`9 IPR2020-00129,
`10 IPR2020-00130,
`11 U.S. Patent No. RE45,380
`12 Exhibit 1903 Declaration of Stephen Jon David 169
`13 Brecker, MD, FRCP, FESC, FACC
`14 Submitted in Support of
`15 Petitioner's Opposition to Patent
`16 Owner's Motion to Amend,
`17 Case Nos. IPR2020-00132,
`18 IPR2020-00134,
`19 U.S. Patent No. RE45,760
`20
`21
`22
`23
`24
`25
`
`2 3
`
`WITNESS: STEPHEN BRECKER, M.D. PAGE
`4 Examination by Mr. Levitt........................ 8
`
`5 6
`
`SPECIAL INSTRUCTIONS:
`7 Page 154, Line 19
`
` E X H I B I T S
`
`8 9
`
`10
`11 EXHIBITS MARKED AND FIRST REFERRED TO: PAGE
`12 Exhibit 1007 United States Patent No. 165
`13 7,736,355 B2,
`14 Date of Patent: June 15, 2010
`15 Exhibit 1008 United States Patent No. 22
`16 7,604,612 B2,
`17 Date of Patent: October 20, 2009
`18 Exhibit 1009 United States Patent No. 44
`19 5,439,445,
`20 Date of Patent: August 8, 1995
`21 Exhibit 1025 United States Patent Application 99
`22 No. 2005/0015073 A1,
`23 Publication Date: January 20,
`24 2005
`25
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`Page 6
`
`1 E X H I B I T S
`2 (Continued)
`3 Exhibit 1904 Declaration of Stephen Jon David 112
`4 Brecker, MD, FRCP, FESC, FACC
`5 Submitted in Support of
`6 Petitioner's Opposition to Patent
`7 Owner's Motion to Amend,
`8 Case Nos. IPR2020-00135,
`9 IPR2020-00136,
`10 U.S. Patent No. RE45,776
`11 Exhibit 2222 Brochure: Pronto V3 Extraction 150
`12 Catheter
`13 Exhibit 2230 Ressemann Figure 16J 42
`14 Exhibit 2231 Drawing by Dr. Stephen Brecker 155
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Page 8
`1 appreciate you've been deposed before a number of
`2 times, so I won't go through the preliminaries. I
`3 would only say that if you get to a point where you
`4 need a break, and I appreciate the time difference
`5 as well, just let me know. It won't be a problem.
`6 STEPHEN BRECKER, M.D.,
`7 duly sworn, was examined and testified as follows:
`8 EXAMINATION
`9 BY MR. LEVITT:
`10 Q. Dr. Brecker, is there a difference between
`11 a lesion in a saphenous graft and a lesion that's
`12 not in a saphenous graft?
`13 A. So there can be a difference. They're all
`14 atheromatous lesions; that's what we're talking
`15 about. Lesions in vein grafts traditionally have
`16 been viewed as having more embolic potential.
`17 Q. What do you mean they having more embolic
`18 protection?
`19 A. No, I said they have more embolic
`20 potential.
`21 Q. Potential. I'm sorry.
`22 And why do they have more embolic
`23 potential?
`24 A. Well, it's not a rule. All I'm saying is
`25 that lesions in vein grafts can have a higher
`
`Page 7
`
`Page 9
`
`1 (PROCEEDINGS, 01/19/2021, 5:03 a.m.)
`2 THE VIDEOGRAPHER: Good morning. Today
`3 is January 19, 2021. The time is 5:03 a.m., and we
`4 are on the record.
`5 Today we'll take the videotaped deposition
`6 in Case No. IPR2020-00138. This deposition is
`7 being held remotely.
`8 Counsel, please state your appearance and
`9 affiliation for the record.
`10 MR. LEVITT: Good morning. I'm Ken
`11 Levitt with Dorsey and Whitney appearing on behalf
`12 of Teleflex. With me today is Derek Vandenburgh of
`13 the Carlson Caspers firm, Pete Keith and Greg Smock
`14 of Teleflex.
`15 I would just note for the record that I
`16 believe this is being done in connection with a
`17 number of IPRs, but I believe the court reporter
`18 already has the caption for it.
`19 MS. ROBERG-PEREZ: On behalf of
`20 petitioner, Medtronic, Sharon Roberg-Perez from
`21 Robins Kaplan. With me are my colleagues Cy Morton
`22 and Ryan Dornberger.
`23 MR. LEVITT: Good morning, Dr. Brecker.
`24 THE WITNESS: Good morning.
`25 MR. LEVITT: I'm Ken Levitt. I
`
`1 burden of friable material and also thrombus.
`2 That's not to say that you couldn't get that type
`3 of lesion in a native vessel.
`4 Q. Is there a difference in the nature of the
`5 friable material from a lesion in a vein versus a
`6 normal vessel?
`7 A. Well, again, you're -- it's not a
`8 hard-and-fast division. It's simply that lesions
`9 in vein grafts can be, and are recognized as
`10 having, a higher potential for friability and
`11 embolization. That is not to say that you couldn't
`12 have the most straightforward lesion in a vein
`13 graft and an incredibly friable thrombotic lesion
`14 in a native vessel.
`15 Part of it might relate to the caliber of
`16 the vessel, but also the atheromatous process. But
`17 it's not that lesions in native vessels are like
`18 this and lesions in vein grafts are like that.
`19 It's not that they are different. It's not a
`20 different disease.
`21 Q. Can you explain what a saphenous vein graft
`22 is, just at a high level of generality?
`23 A. So a saphenous vein graft is the term used
`24 to describe removing a segment of a patient's leg
`25 vein and using it as -- in the context that we're
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`Page 10
`1 discussing -- a coronary artery bypass graft, where
`2 you take a length of normal vein from a patient's
`3 leg and use it as a graft, suturing the top end to
`4 the aorta and the bottom end to the coronary
`5 vessel. The structure is a vein. And there are
`6 differences between the wall of an artery and the
`7 wall of a vein.
`8 You can also use vein grafts for other
`9 indications. You can use segments of vein grafts
`10 just as a -- sorry, segments of vein just as a
`11 patch, and you can use it in treating other parts
`12 of the vascular system.
`13 Q. So generally speaking, a segment of vein is
`14 moved from the leg to the coronary context in order
`15 to go around some lesion that, for whatever reason,
`16 isn't being treated directly?
`17 A. You're correct. It's used to bypass a
`18 lesion, but it's the alternative form of -- this is
`19 coronary artery bypass surgery, so that's the
`20 treatment that's being given.
`21 Q. How does thrombus differ from embolic
`22 material?
`23 MS. ROBERG-PEREZ: Objection. Form.
`24 A. Well, thrombus is a blood clot, in its
`25 simplest term. Embolic material is a term used to
`
`Page 11
`1 describe material that moves from one portion of
`2 the body to another. And in a general term, there
`3 are a large number of different types of things
`4 that can embolize that doesn't necessarily have to
`5 be thrombus.
`6 Q. One of which is a lesion?
`7 A. No, not -- I wasn't thinking of that. I
`8 think your question was what -- how does it differ
`9 from embolic material.
`10 So embolic material can be many different
`11 things: blood clots in orthopedic surgery; you can
`12 have fat embolism, the fat can embolize as the
`13 bones are being manipulated; if air is introduced
`14 into the circulation in an angiographic procedure,
`15 you can get air embolism.
`16 So when you say "lesion material," I'm not
`17 completely sure -- if you mean in a coronary artery
`18 do you get embolization of more than just blood
`19 clots, the answer is yes. In a coronary lesion,
`20 whether it's in a native vessel or a vein graft,
`21 you could get embolization of blood clots, of some
`22 plaque material, some cholesterol, fibrin.
`23 Many -- there's components to the lesion,
`24 and some of that could embolize. I would think
`25 that the largest component of an embolus in a
`
`Page 12
`
`1 coronary vessel is blood clot.
`2 Q. Would it be fair to say that embolic
`3 material released during a stenting procedure is
`4 typically more particulate in nature than thrombus?
`5 MS. ROBERG-PEREZ: Objection. Form.
`6 A. Not necessarily. It could be. Might not
`7 be.
`8 Q. Is it fair to say that embolic material
`9 that's released during a stenting procedure is
`10 typically carried into the bloodstream?
`11 A. Well, it's carried downstream.
`12 Q. Let's talk about suction catheters for a
`13 few minutes. Dr. Brecker, have you ever put a
`14 stent catheter through a suction catheter?
`15 A. So I've been asked this several times in
`16 previous depositions, and my answer is the same: I
`17 have not.
`18 Q. So let's say, hypothetically, that you
`19 wanted to put a stent catheter through a suction
`20 catheter such as Itou. If you were to put the
`21 suction catheter in and suction, and then advance
`22 the stent catheter through the suction catheter, is
`23 it fair to say you would push residual embolic
`24 material downstream into the bloodstream?
`25 A. So could you just repeat the sequence to me
`
`Page 13
`
`1 again?
`2 Q. Sure. If you were to insert a suction
`3 catheter and then use it to suction material, and
`4 then leaving the suction catheter in, insert a
`5 stent catheter into the guide catheter and the
`6 suction catheter, would you then push residual
`7 material downstream into the bloodstream?
`8 A. Well, my answer is: Not necessarily.
`9 There had been teaching of the use of suction and
`10 aspiration catheters to deliver stents, and
`11 specific teaching that would have advocated the
`12 process you described. I think it would depend a
`13 lot on the nature of the vessel, the nature of what
`14 you were treating.
`15 I can envisage a situation where you put
`16 the suction catheter, get complete clearance of
`17 whatever you're wanting to clear, got the good
`18 backflush. You wouldn't necessarily, then,
`19 embolize anything. It's certainly a theoretical
`20 possibility, but you wouldn't -- it wouldn't be a
`21 definite, by any means.
`22 Q. How would you backflush the suction
`23 catheter?
`24 A. Suction.
`25 Q. Is there still a risk, though, that without
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`Page 14
`1 removing the suction catheter and flushing it,
`2 there's going to be residual embolic material in
`3 the catheter?
`4 A. It's a possibility. But there had -- there
`5 was -- there were descriptions of this in
`6 literature that specifically said not to remove the
`7 aspiration catheter.
`8 So it wasn't -- it wasn't that you would --
`9 that it couldn't be done; it certainly could. And
`10 you would want to, to remove procedural steps.
`11 There would be disadvantages to potentially
`12 removing the aspiration catheter at that point
`13 because any catheter change brings with it a
`14 prolongation of the procedure, which itself can
`15 lead to blood clot or the introduction of air. And
`16 I've seen both of those happen during catheter
`17 exchange procedures.
`18 So during an interventional procedure, it's
`19 a balance as to the order in which you do things.
`20 And you certainly wouldn't not simply leave the
`21 aspiration catheter there to advance a stent if
`22 that was the appropriate thing to do in the
`23 procedure.
`24 Q. Is it fair to say that if you leave the
`25 aspiration catheter in after aspirating out
`
`Page 16
`1 that the aspirational suction catheter can be sized
`2 such that you can suction with a stent in place.
`3 So, again, it depends on the relative sizes
`4 of the catheters that we're talking about. But as
`5 a general rule, I would not agree that it means you
`6 couldn't then suction. It had been specifically
`7 taught that you could.
`8 Q. Is it fair to say that having the stent
`9 catheter in the suction catheter while performing
`10 the suction would restrict the suction?
`11 A. Well, I've answered, I think. It would
`12 depend on the size of the stent, size of the
`13 catheter, the nature of what you were sucking.
`14 It's a possible theoretical point, yes.
`15 But as I've said, that specific procedure that
`16 you're describing had been taught in prior art.
`17 Q. Is there a typical size stent catheter that
`18 you advance through a 6 French guide catheter in a
`19 coronary intervention procedure?
`20 MS. ROBERG-PEREZ: Objection. Form.
`21 A. Well, there's a large range of stents. And
`22 their crossing profiles are documented.
`23 Q. So if you're using a 6 French guide
`24 catheter and you have a suction catheter inserted
`25 through that, and a stent with an .056 crossing
`
`Page 15
`
`Page 17
`
`1 thrombotic material, there is a risk that there's
`2 going to be residual thrombotic material in the
`3 suction catheter that is then pushed downstream
`4 when you advance the stent catheter through the
`5 suction catheter?
`6 MS. ROBERG-PEREZ: Objection. Asked
`7 and answered.
`8 A. I think I've said that, that it's a
`9 potential risk. But if you've cleared the
`10 thrombus, you've got good backflush by suction,
`11 you've got precedent in literature and practice.
`12 It would not be an absolute contraindication.
`13 It's a potential risk. You're balancing
`14 that against the risk of the catheter exchange,
`15 prolonging the procedure, that itself, as I said,
`16 can produce thrombus and introducing air.
`17 Q. Dr. Brecker, if you were to insert a
`18 suction catheter and then, before suctioning,
`19 advance a stent catheter into the suction catheter,
`20 is it accurate to say that if you were then to
`21 apply suction to the suction catheter, the presence
`22 of the stent and stent catheter would inhibit the
`23 suction?
`24 A. So that's an interesting question. It's
`25 dealt with explicitly in prior art, where it says
`
`1 profile, is that a workable combination?
`2 A. I don't know. I haven't -- I haven't
`3 considered that specifically. If it relates to an
`4 opinion I've given in a declaration, I'd be happy
`5 to go to it. I don't think I have considered that
`6 specific scenario that you're setting out.
`7 Q. Have you considered the -- are there stent
`8 catheter and suction catheter combinations where
`9 inserting stent catheter through the suction
`10 catheter, and then applying suction to the suction
`11 catheter, would have reduced suction flow because
`12 of the presence of a stent catheter inside the
`13 suction catheter?
`14 A. So I haven't given an opinion on that
`15 specific point.
`16 Q. Sitting here today, you don't have an
`17 opinion on that?
`18 A. I haven't considered it. I hadn't -- I
`19 don't think I've given an opinion in any of the
`20 declarations that are the subject of today. So I
`21 haven't done that experimentation. I haven't done
`22 that exercise of assessing that.
`23 Q. Okay. So let me ask a different question.
`24 Dr. Brecker, if you were to put a suction catheter
`25 in and then advance the stent catheter through the
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`Page 18
`1 suction catheter, and then treat the lesion using
`2 the stent, and then suction, would you expect to be
`3 able to remove any embolic material that's
`4 generated as a result of the stenting procedure?
`5 A. You could, certainly. And as I said, there
`6 is teaching of that specific sequence in the prior
`7 art.
`8 Q. And just to be clear -- I want to make sure
`9 my question came through.
`10 The suction catheter would be advanced
`11 first, and then the stent catheter would be
`12 advanced through the suction catheter, the lesion
`13 would be treated with a stent, and at that point,
`14 isn't it fair to say that if there is thrombus in
`15 the blood vessel, the stent catheter has already
`16 pushed it downstream?
`17 A. It may have done; it may not. You can --
`18 if there were thrombus preexisting, then you might.
`19 However, thrombus can occur after stenting as well.
`20 Q. If embolic material is released during that
`21 stenting procedure, is it fair to say that the
`22 embolic material would be carried downstream before
`23 it could be sucked up by the suction catheter?
`24 A. It could be. And if you were worried about
`25 that, then it would have been advisable to put a
`
`Page 20
`
`1 child catheter."
`2 Do you see that sentence?
`3 A. I do.
`4 Q. And then there's two citations that follow,
`5 correct?
`6 A. Correct.
`7 Q. I'd like, first, to direct you to
`8 Exhibit 1026, which is the Abrahamson patent.
`9 A. So is that in -- I'm not sure which binder
`10 that's in, or whether it's on Exhibit Share.
`11 MS. ROBERG-PEREZ: This isn't in the
`12 hard copies that we got.
`13 MR. LEVITT: If it's not handy, Derek
`14 could load it for us in the Exhibit Share. It was
`15 one of the prior references that was discussed in
`16 your report.
`17 A. So I just have to move my laptop to access
`18 the desktop that has the Exhibit Share on.
`19 Q. Sure. And if it saves a step, I'll let you
`20 know that the next exhibit we're going to discuss
`21 will be Ressemann. I'm sure you probably predicted
`22 that.
`23 A. I have Ressemann as a hard copy. So I have
`24 this other folder from the deposition from last
`25 week that has several pieces of the prior art, but
`
`Page 19
`1 distal protection device in through the aspiration
`2 catheter. So that you -- the first thing you do is
`3 put a distal protection device in, and then you're
`4 protected.
`5 Q. And is it fair to say that Itou is not a
`6 distal protection device?
`7 A. Itou is a suction or aspiration catheter.
`8 There's nothing about Itou that says you couldn't
`9 use a distal protection device with it.
`10 Q. Dr. Brecker, I'd like you to turn to your
`11 Exhibit 1900. Do you have that handy? And I
`12 believe it's loaded already in the Exhibit Share.
`13 A. I have a paper copy. And I have it on the
`14 Veritext. So I have both. But I'll use the paper
`15 copy.
`16 (Exhibit No. 1900 was introduced.)
`17 Q. Very good. Thank you.
`18 Let me direct your attention first to
`19 paragraph 171 of Exhibit 1900.
`20 A. Yes.
`21 Q. Paragraph 171 says -- and I'll just read it
`22 for the record -- "A POSITA was also motivated to
`23 use a side opening because doing so facilitates
`24 'smoother' reception of the interventional
`25 cardiology device as it enters the lumen of the
`
`Page 21
`
`1 it doesn't have 18- -- I'm sorry, 1026.
`2 MR. VANDENBURGH: It should be on the
`3 Exhibit Share now.
`4 (Exhibit No. 1026 was introduced.)
`5 A. Yes, I have this.
`6 Q. Very good. So the portion of Exhibit 1026
`7 that you cite in this paragraph 171 of Exhibit 1900
`8 is lines -- or column 3, lines 6 to 9.
`9 Is that right?
`10 A. Column 3, lines 6 to 9.
`11 Q. Yes. And my question about Abrahamson is
`12 straightforward. Is it accurate to say that this
`13 patent does not teach advancing an interventional
`14 cardiology device through a side opening, as we've
`15 been discussing in this case?
`16 A. So I would just -- I would just need a
`17 minute to refresh my memory on this. Obviously
`18 there's so many different pieces of prior art and
`19 so many different citations, I want to just be
`20 sure.
`21 (Reviewing document.)
`22 Yes, this patent does not explicitly teach
`23 the passage of an interventional cardiology device
`24 through the side opening.
`25 Q. And, in fact, the side opening that's being
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`Page 22
`
`1 referred to in this passage is an opening in a
`2 sidewall, correct?
`3 A. That's how it's described in the patent.
`4 Q. And if you look, for example, at Figure 3,
`5 is it fair to say that's an example of an opening
`6 in the sidewall?
`7 A. I just want to see how Figure 3 is
`8 described. (Reviewing document.)
`9 That's one -- that is one example of a
`10 side- -- of an opening in a sidewall.
`11 Q. Such as is described in the passage at
`12 column 3, lines 6 to 9?
`13 A. I just want to try and see. It is -- it's
`14 described as a side opening. Yes.
`15 Q. It's described as a side opening, but it's
`16 actually an opening in a sidewall, correct?
`17 A. It is.
`18 Q. Let me direct your attention now to the
`19 Ressemann reference. Let me know when it's handy.
`20 (Exhibit No. 1008 was introduced.)
`21 A. Yep, I have that.
`22 Q. So the passage that is cited in your
`23 Exhibit 1900, your declaration, at paragraph 171,
`24 is designated as lines 55 to 57 of column 6,
`25 correct?
`
`Page 24
`1 A. Well, you could read it that the proximal
`2 distal ends -- it doesn't -- it just said the
`3 proximal and distal ends are angled, and then it
`4 gives the reasons why they're angled.
`5 You're -- you just -- are you splitting it
`6 up in some way? I didn't quite follow.
`7 Q. Let me ask you: Do you read this paragraph
`8 to say that angling the distal end facilitates
`9 smoother passage of cardiology devices through the
`10 proximal end of the evacuation lumen?
`11 MS. ROBERG-PEREZ: Objection. Form.
`12 A. It doesn't say that. It says through
`13 the --
`14 Q. Is it fair --
`15 A. I'm sorry. It doesn't --
`16 Q. I didn't mean to interrupt. I'm sorry. Go
`17 ahead.
`18 A. I don't think it says that. It says,
`19 "...to facilitate smoother passage of other
`20 therapeutic devices through the evacuation lumen of
`21 the evacuation head." And you put a lumen in and
`22 out, and then it goes in and out.
`23 So there are four points at which during a
`24 procedure an interventional cardiology device would
`25 go in and out of the evacuation head of Ressemann.
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`Page 25
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`1 A. That's correct.
`2 Q. So I'm going to ask you to read a slightly
`3 longer passage that's in Ressemann, to yourself.
`4 If you wouldn't mind, read column 6, lines 52 to
`5 60. And let me know when you're done.
`6 A. Okay. (Reviewing document.)
`7 I've read 52 to 60.
`8 Q. Very good. Just for the record, I'm going
`9 to read in the sentence that I want to talk about,
`10 so the record is clear.
`11 It starts at line 52, and it says, "The
`12 proximal and distal ends 140a, 140b of the
`13 evacuation lumen 140 are preferably angled to allow
`14 for smoother passage of the evacuation sheath
`15 assembly 100 through a guide catheter, and into a
`16 blood vessel, and to facilitate smoother passage of
`17 other therapeutic devices through the evacuation
`18 lumen 140 of the evacuation head 132."
`19 Did I read that correctly?
`20 A. Yes.
`21 Q. So the first part of this, is it fair to
`22 say that it indicates that the distal end is
`23 angled -- the distal end of the head is angled to
`24 allow for smoother passage of the evacuation head
`25 through a guide catheter and into the blood vessel?
`
`1 And it's saying it's smooth -- the proximal and
`2 distal ends that are angled facilitate that
`3 passage.
`4 So the way I read that is it's facilitating
`5 both in and out of both the proximal and distal
`6 ends.
`7 Q. Do you read this paragraph to say that
`8 angling the proximal end allows for smoother
`9 passage of the evacuation sheath through the guide
`10 catheter?
`11 A. So let me just read that again. Could you
`12 just say that again?
`13 Q. Sure. Do you read this passage to say that
`14 angling the proximal end of the evacuation sheath
`15 facilitates smoother passage of the evacuation
`16 sheath through the guide catheter?
`17 A. It might do. Yes. I haven't split this
`18 up. I've not said proximal end will only do this
`19 and the distal end will do this.
`20 What's in the passage is angling the
`21 proximal and distal ends will do all of the
`22 following. I'm not trying to take it further than
`23 what's written on the page.
`24 Q. Dr. Brecker, is it fair to say this
`25 sentence indicates that the angled end facilitates
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`Page 26
`1 smoother passage of the therapeutic devices through
`2 the evacuation lumen rather than into the
`3 evacuation lumen?
`4 MS. ROBERG-PEREZ: Objection. Form.
`5 A. Well, it's got to get into the lumen. And
`6 therefore, interventional device going through, it
`7 has to get into. So I don't exclude easier passage
`8 into the lumen.
`9 Q. Is there a difference between entering the
`10 lumen and then, once in the lumen, advancing
`11 through the lumen?
`12 MS. ROBERG-PEREZ: Object to form.
`13 A. Sorry. Could -- so I think your question
`14 is, is there a -- was there a difference between
`15 entering the lumen and going through the lumen?
`16 So my answer is: If the entrance is making
`17 passage through the lumen easier, I can't see how
`18 you can disassociate that from easier entrance into
`19 the lumen.
`20 So it's easier going into the lumen and
`21 it's easier coming out of the lumen through two
`22 angled entrances. In fact, if you -- if you just
`23 think about the passage going right through the
`24 very middle of the catheter, that might -- that bit
`25 is perhaps less influenced than actually going into
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`1 enters, it could interact.
`2 Q. And, in fact, isn't that a particular
`3 concern of Ressemann?
`4 MS. ROBERG-PEREZ: Object to form.
`5 A. So could you take me to the passage you're
`6 referring to?
`7 Q. Sure. If you could go to column 25,
`8 lines 27 to 29. And let me know when you're there.
`9 A. Yep, I'm here.
`10 Q. And so I'll read the sentence into the
`11 record, just for clarity. "Stent delivery
`12 catheters, for example, are particularly subject to
`13 hanging up on the proximal end of the evacuation
`14 head 2132 without reverse bevel 2125."
`15 Do you see that sentence?
`16 A. I do. Yeah.
`17 Q. And what's your understanding of that
`18 phrase?
`19 A. Well, I read it exactly as it's stated.
`20 But I don't read anything more or less into it.
`21 I'm a little bit confused by it because there is
`22 very little in Ressemann about this adaptation. No
`23 real explanation of how what is written there would
`24 work. And, in fact, almost counterintuitive to a
`25 cardiologist.
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`Page 29
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`1 the lumen.
`2 So I believe that the POSITA reading this
`3 paragraph would understand that the angled openings
`4 are facilitating the passage of an interventional
`5 cardiology device into, through, and out of the
`6 lumen.
`7 Q. Dr. Brecker, is it fair to say that once
`8 the -- once a stent has advanced into the lumen,
`9 there's no longer a risk of stent catch on the
`10 proximal opening of the lumen?
`11 MS. ROBERG-PEREZ: Object to form.
`12 A. Well, the stent itself, once it's passed
`13 through, can't then catch on the proximal side
`14 opening. It could potentially catch on the distal,
`15 and there could also be interaction between the
`16 shaft of the stent catheter and the entrance to the
`17 side opening.
`18 Q. And is it accurate to say that there could
`19 be interaction between the stent strut and the
`20 proximal side opening before the stent catheter
`21 enters the lumen of the tube?
`22 A. It is accurate to say that there could be
`23 interaction between the stent struts and the
`24 proximal side opening as it enters. I can't
`25 remember if you said before it enters, but as it
`
`1 Q. Is it fair to say that Ressemann teaches
`2 that if there's not a reverse bevel, that a stent
`3 delivery catheter is particularly subject to
`4 hanging up on that proximal end opening of the
`5 evacuation head?
`6 A. Well, I think it's -- I'm sorry.
`7 MS. ROBERG-PEREZ: Object to form.
`8 A. I think it's half a line of a nearly
`9 100-page patent. So I don't say -- I would not
`10 read Ressemann and say that it teaches that you
`11 have to have a reverse bevel. No.
`12 Q. So let me try my question a little bit
`13 differently.
`14 Isn't it fair to say that Ressemann says in
`15 this sentence that if there's not a reverse bevel,
`16 that a stent delivery catheter is particularly
`17 subject to hanging up on the proximal end of the
`18 evacuation head?
`19 A. This is what is written in this sentence.
`20 And my caveat to that is that the cardiologist
`21 would be raising an eyebrow, or more, at -- it's
`22 very intuitive to understand how an angled side
`23 opening would reduce the possibility of hang-up,
`24 and how putting something else in the way would --
`25 without putting something else in the way, you're
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`1 prone to hang-up. I don't follow it myself.
`2 Q. And so whether you agree or not, isn't it
`3 fair to say that Ressemann has a statement that
`4 having an angled proximal end helps