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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
` DR. PAUL ZALESKY
`
`DATE: January 13, 2021
`
`TIME: 9:13 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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`Veritext Legal Solutions
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`Page 2
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`Page 4
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`1 INDEX
`2 WITNESS: DR. PAUL ZALESKY PAGE:
`3 EXAMINATION BY MS. NORGARD................. 7
`4 EXAMINATION BY MS. ROBERG-PEREZ............ 236
`5 FURTHER EXAMINATION BY MS. NORGARD......... 247
`
`6 7 8
`
`EXHIBITS REFERRED TO: PAGE:
`9 Exhibit 1755 Declaration of Dr. Zalesky in
`10 Support of Petitioner's Reply
`11 Addressing Conception and
`12 Reduction to Practice........... 25
`13 EXHIBIT 1763 Drawings of GuideLiner,
`14 VSI_00000818-829................ 163
`15 EXHIBIT 1771 3/11/97 FDA Design Control
`16 Guidance for Medical Device
`17 Manufacturers................... 98
`18 EXHIBIT 1772 FDA 21 CFR Parts 808, 812 and
`19 820............................. 99
`20 EXHIBIT 2005 Part List for GuideLiner........ 144
`21 EXHIBIT 2022 Rapid Exchange Concept Drawing,
`22 PAT0000033...................... 180
`23 EXHIBIT 2024 8/24/05 Product Requirements
`24 for GuideLiner Catheter System,
`25 VSIMDT00030178-30181............ 244
`
`1 APPEARANCES
`2 (All parties appeared via videoconference)
`3 ON BEHALF OF THE PETITIONERS:
`4 Ms. Sharon Roberg-Perez, Esq.
`5 Mr. Cyrus A. Morton, Esq.
`6 Ms. Emily J. Tremblay, Esq.
`7 ROBINS KAPLAN, LLP
`8 800 LaSalle Avenue, Suite 2800
`9 Minneapolis, Minnesota 55401
`10 (612) 349-8500
`11 sroberg-perez@robinskaplan.com
`12 cmorton@robinskaplan.com
`13 etremblay@robinskaplan.com
`14
`15 ON BEHALF OF THE PATENT OWNER:
`16 Ms. Tara C. Norgard, Esq.
`17 Mr. Alexander S. Rinn, Esq.
`18 Mr. Joseph W. Winkels, Esq.
`19 CARLSON, CASPERS, VANDENBURGH & LINDQUIST
`20 225 South Sixth Street, Suite 4200
`21 Minneapolis, Minnesota 55402
`22 (612) 436-9600
`23 tnorgard@carlsoncaspers.com
`24 arinn@carlsoncaspers.com
`25 jwinkels@carlsoncaspers.com
`
`Page 3
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`Page 5
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`1 (EXHIBITS continued)
`2 EXHIBIT 2089 February and April 2005 MED
`3 Sales Documents and Invoice..... 146
`4 EXHIBIT 2092 April and June 2005 MED Sales
`5 Documents and Invoice........... 146
`6 EXHIBIT 2113 Drawings of Hypotube............ 167
`7 Exhibit 2225 Declaration of Dr. Paul Zalesky
`8 in Opposition to Motion for
`9 Preliminary Injunction.......... 14
`10 EXHIBIT 2227 Label for Pronto V3............. 171
`11
`12 (Original exhibits attached to original transcript;
`13 copies provided to counsel.)
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
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`1 APPEARANCES (Continued)
`
`23
`
`ALSO PRESENT:
`4 Phil Glauberson - Videographer
`5 Greg Smock - Teleflex
`6 Howard Cyr - Teleflex
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`789
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`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 9:13 a.m. Central Time,
`4 January 13, 2021.
`5 Please note that the microphones are
`6 sensitive and may pick up whispering and private
`7 conversations. Please mute your microphone
`8 whenever possible. Audio and video recording will
`9 continue to take place unless all parties agree to
`10 go off the record.
`11 This is Media Unit 1 of the
`12 video-recorded deposition of Dr. Paul Zalesky in
`13 the matter of Medtronic, Inc., et al. versus
`14 Teleflex Innovations S.A.R.L. filed in the United
`15 States Patent and Trademark Office, IPR2020-00126,
`16 IPR2020-00128, IPR2020-00129, IPR2020-00134 --
`17 132, IPR2020-00134, IPR2020-00135, and
`18 IPR2020-00137.
`19 This deposition is being held
`20 remotely. My name is Phil Glauberson from the
`21 firm Veritext, and I am the videographer. The
`22 court reporter is Paula Richter from Veritext.
`23 I am not authorized to administer an
`24 oath, I am not related to any party in this
`25 action, nor am I financially interested in the
`
`1 patent owner in this case.
`2 Have you ever been --
`3 A. Good morning.
`4 Q. Good morning. Have you ever been deposed
`5 before?
`6 A. I have.
`7 Q. How many times?
`8 A. Something between five and ten over the last,
`9 probably, 15 years.
`10 Q. And of those five to ten times that you've
`11 been deposed, about how many of those times were
`12 you serving as an expert witness?
`13 A. Approximately five or six.
`14 Q. And when is the most recent time you've been
`15 deposed?
`16 A. I think it was a year and a half, possibly
`17 two years ago. It was an IPR case.
`18 Q. Which case was that?
`19 A. I don't have the details in front of me. It
`20 regarded -- I was actually representing the patent
`21 owner with an attorney out of California.
`22 Q. And who was the patent owner in that case?
`23 A. Again, I don't have any of that file in front
`24 of me right now.
`25 Q. You don't know who you were representing in
`
`Page 7
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`Page 9
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`1 outcome.
`2 Counsel will please now state their
`3 appearances and affiliations for the record. If
`4 there are any objections to proceeding or to the
`5 court reporter administering the oath virtually,
`6 please state them at the time of your appearance,
`7 beginning with the noticing attorney.
`8 MS. NORGARD: Good morning. This is
`9 Tara Norgard on behalf of patent owner. Here
`10 appearing on the remote deposition with me today
`11 is Alex Rinn and Joe Winkels. The three of us are
`12 from the Carlson Caspers law firm. Also appearing
`13 on behalf of the patent owner is Greg Smock and
`14 Howard Cyr, both of whom are with Teleflex.
`15 MS. ROBERG-PEREZ: Sharon
`16 Roberg-Perez on behalf of Petitioner Medtronic.
`17 With me are my colleagues, Emily Tremblay and
`18 Cy Morton of the firm Robins Kaplan.
`19 DR. PAUL ZALESKY,
`20 duly sworn, was examined and testified as follows:
`21 EXAMINATION
`22 BY MS. NORGARD:
`23 Q. Good morning, Dr. Zalesky. As I mentioned a
`24 moment ago, I am Tara Norgard. I'm with the
`25 Carlson Caspers law firm, and I represent the
`
`1 that action?
`2 A. I was representing the patent owner, but I
`3 don't have any of that information in front of me.
`4 I'd have to go back to my records.
`5 Q. So as you sit here today, you do not know the
`6 name of the party for whom you served as an expert
`7 witness for the most recent IPR where you
`8 testified?
`9 A. I just don't recall the name because of the
`10 details and so many other projects in the
`11 meantime.
`12 Q. What was the technology?
`13 A. It was a complex algorithm for decomposing or
`14 deconstructing complex intracardiac wave forms in
`15 order to diagnose arrythmia.
`16 Q. And did you participate in the IPR trial of
`17 that matter?
`18 A. I did not. I just prepared a formal report
`19 and I was deposed.
`20 Q. Was that deposition taken remotely or was it
`21 in person?
`22 A. It was in person in Providence, Rhode Island.
`23 Q. Well, obviously, this deposition is taking
`24 place remotely.
`25 Have you ever participated in a
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`1 remote deposition?
`2 A. Not a deposition, per se. I've participated
`3 in a number of remote proceedings, including
`4 arbitration for hearings and trial, three judges.
`5 Q. And was that taken in a similar platform to
`6 the Zoom platform that we're experiencing here
`7 today?
`8 A. Yes.
`9 Q. Well, then you may know this from your
`10 experience in those proceedings, but it is
`11 important in any deposition, but especially when
`12 we are remote here today, that we speak slowly and
`13 clearly for our court reporter, so we get a clear
`14 record.
`15 It's also important we don't speak
`16 over each other. And it is important that we use
`17 words, not nods or hand gestures to make sure that
`18 our communications are accurately reflected in the
`19 record.
`20 Do you understand that?
`21 A. I do.
`22 Q. The goal here is to have a clear and accurate
`23 record, so if you don't understand a question I'm
`24 asking, please ask me to clarify or rephrase it.
`25 Can you do that?
`
`1 A. I have not.
`2 Q. A set of hard-copy exhibits was also
`3 delivered to your home.
`4 Did you receive them?
`5 A. I received them yesterday.
`6 Q. And do you have them with you?
`7 A. I do.
`8 Q. Have you opened them?
`9 A. I didn't hear that last part. Sorry.
`10 Q. Have you opened the package that was sent to
`11 you with the hard-copy exhibits?
`12 A. Yes.
`13 Q. And have you reviewed them?
`14 A. I have not re-reviewed the copies you sent.
`15 I have reviewed versions sent by Medtronic
`16 counsel.
`17 Q. So have you opened the package -- I'm sorry.
`18 Have you reviewed at all the packet -- the
`19 contents of the package that we sent to you for
`20 this deposition today?
`21 A. Yes. I opened each of the binders, and they
`22 look -- were very -- basically identical to
`23 binders I had already received in the past. I
`24 just verified the contents, for instance, of my
`25 declaration. I did not, you know, re-re-re-review
`
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`1 A. Yes.
`2 Q. Otherwise, if you answer the question that
`3 I'm asking, I'm going to assume that you
`4 understood the question; is that fair?
`5 A. That is.
`6 Q. We'll try to take breaks throughout the day,
`7 but if there's ever a point where you need a
`8 break, please let us know. I would only ask that
`9 you finish answering the question that's been
`10 asked before you intervene for that break.
`11 Is that a fair request?
`12 A. It is.
`13 Q. We may discuss some exhibits today, and
`14 before we got on the record, we got you on to
`15 Exhibit Share, which is the electronic version of
`16 the exhibits, and that's now up and running on
`17 your screen, correct?
`18 A. The my screen is largely the Zoom meeting.
`19 I'm going to need to minimize it to look at the
`20 rest of this. Is that what you want me to do?
`21 Q. Well, when we got on the record, you had
`22 access to Exhibit Share. We don't need to go
`23 there yet, but I want to make sure that you still
`24 have access to it.
`25 You haven't turned it off, have you?
`
`1 the same contents I had seen in the past.
`2 Q. Do you have those hard-copy exhibits --
`3 A. Yes, I do.
`4 Q. -- that we sent you here today?
`5 A. I do.
`6 Q. Dr. Zalesky, where are you physically located
`7 today?
`8 A. In my home office in East Greenwich,
`9 Rhode Island.
`10 Q. And is there anyone in the room with you?
`11 A. No, there is not.
`12 Q. Is there any reason that you are not able to
`13 testify fully and truthfully here today?
`14 A. No.
`15 Q. Are you on any medications?
`16 A. Not anything, no.
`17 Q. Dr. Zalesky, when were you retained for this
`18 dispute?
`19 A. It was an or about October 1st of 2019.
`20 Q. And who contacted you?
`21 A. I was contacted by the attorney, Sherry and
`22 Emily.
`23 Q. And were you retained initially for the
`24 district court litigation that proceeded these IPR
`25 proceedings?
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`1 A. I was, in 2019.
`2 Q. And you prepared a declaration in that
`3 litigation, right?
`4 A. Yes, I did.
`5 MS. NORGARD: I'm going to ask that
`6 we mark Exhibit 2225, please.
`7 MS. ROBERG-PEREZ: I'm going to
`8 object on scope.
`9 THE VIDEOGRAPHER: This is the
`10 videographer. Are we okay with the witness's --
`11 the humming that's going on or should we try to
`12 correct it or should we just move forward?
`13 MS. NORGARD: It is rather
`14 distracting. We were able to correct it before,
`15 Dr. Zalesky. I'm not sure if that was because you
`16 moved away a cell phone or some other electronic
`17 device, but there is a fair bit of feedback that's
`18 happening right now.
`19 THE WITNESS: The only thing I can
`20 guess is, I hear a very slight hum from the fan in
`21 my laptop.
`22 BY MS. NORGARD:
`23 Q. Well, it's pretty well amplified for us, but
`24 let's just continue on, and if anybody finds it to
`25 be overbearing, perhaps we can address it at a
`
`1 Q. And feel free to scroll through it,
`2 Dr. Zalesky, but is this the declaration that you
`3 submitted in the litigation in the district court
`4 in Minnesota in the same dispute between Vascular
`5 Solutions, et al., and Medtronic regarding these
`6 patents?
`7 MS. ROBERG-PEREZ: Objection; scope.
`8 THE WITNESS: Yes, I believe it is.
`9 BY MS. NORGARD:
`10 Q. Go to the last page, please.
`11 A. Signature page or before that?
`12 Q. The signature page.
`13 A. Okay.
`14 Q. Are you there?
`15 A. I am.
`16 Q. Is that your signature on page 48 of this
`17 declaration that's been marked as Exhibit 2225?
`18 A. Yes.
`19 Q. And it's dated November 14th, 2019.
`20 Do you see that?
`21 A. Yes.
`22 Q. Did you sign this document on November 14th
`23 of 2019?
`24 A. I believe so.
`25 Q. And you declared under the penalty of perjury
`
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`1 break. How does that sound?
`2 Dr. Zalesky, do you see Exhibit 2225
`3 on your screen?
`4 A. I'm sorry. Please repeat that. I was trying
`5 to adjust the laptop to see if I could knock down
`6 the sound.
`7 What was the question?
`8 Q. In the Marked Exhibit folder on Exhibit
`9 Share, you should be seeing Exhibit 2225.
`10 Do you see that?
`11 A. It still says folder is empty.
`12 Q. If you go to the top, the top and refresh, as
`13 your counsel has advised you earlier.
`14 A. I'm sorry. You want me to do what?
`15 Q. I want you to go to the top of the screen and
`16 refresh the screen.
`17 Do you know how to refresh the
`18 screen?
`19 A. 2225?
`20 Q. Correct.
`21 A. You want me to open that?
`22 Q. Please.
`23 A. Okay.
`24 Q. Do you have it there in front of you now?
`25 A. I do.
`
`1 that the contents of this declaration at
`2 Exhibit 2225 are true and correct, right?
`3 A. Yes.
`4 Q. Thank you.
`5 It's up to you how you want to deal
`6 with the exhibits on your screen, but I'm just
`7 going tell you right now that if you want to exit
`8 out of an exhibit at any time, there is a caret at
`9 the upper left-hand corner right next to the
`10 label.
`11 Do you see it, right next to
`12 Exhibit 2225 PDF?
`13 A. I do.
`14 Q. And if you hit that, it will take you back to
`15 the folder.
`16 A. Okay.
`17 Q. You're welcome to navigate how you wish, but
`18 I just wanted to let you know that that's the way
`19 you get back to the exhibit list.
`20 A. Okay.
`21 Q. So, Dr. Zalesky, this deposition is taking
`22 place in the context of the IPRs, correct?
`23 A. Yes.
`24 Q. Did you help prepare Medtronic's petitions in
`25 these IPRs?
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`1 A. Yes.
`2 Q. You've also submitted a declaration on
`3 conception and reduction to practice, correct?
`4 A. Yes.
`5 Q. You've also submitted a declaration on
`6 copying, correct?
`7 A. Yes.
`8 Q. You've also submitted a declaration on the
`9 patent owner's motion to amend; is that correct?
`10 A. Yes.
`11 Q. Have you prepared any other declarations for
`12 the dispute between these parties regarding these
`13 patents?
`14 A. No.
`15 Q. How many hours have you spent on this matter?
`16 A. I couldn't hear that.
`17 Q. How many hours have you spent on this matter?
`18 A. So when you say "this matter," you mean all
`19 of those declarations you just described?
`20 Q. Well, let's talk about the matter inclusive
`21 of the district court litigation.
`22 So since you were retained, how many
`23 hours have you spent on this matter?
`24 A. So the district court declaration from 2019,
`25 I would estimate something like 40 or 50 hours.
`
`1 Q. Did you prepare for your deposition here
`2 today?
`3 A. I did.
`4 Q. What did you do?
`5 A. I spent a couple of hours the day before
`6 yesterday with counsel, and I spent an hour or so
`7 yesterday just re-reviewing my declaration.
`8 Q. Did you do anything else to prepare for your
`9 deposition here today?
`10 A. No. Other than referring to some of the
`11 selected exhibits.
`12 Q. Which exhibits did you review?
`13 A. I couldn't -- I couldn't tell you all of
`14 them. There were quite a few of them that I just
`15 breezed through, just to make sure I recalled
`16 where they were.
`17 Q. And you said you prepared with counsel. I
`18 don't want to know the contents of your
`19 conversation, but who did you prepare with?
`20 A. With Sherry and with Emily.
`21 Q. Did you have any other conversations about
`22 this deposition before we went on the record here
`23 today?
`24 A. No.
`25 Q. Have you spoken at any point with any of the
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`1 Q. And how about for the IPR proceedings?
`2 A. The IPR, probably a bit more than 50 hours.
`3 Q. So a bit more than 50 hours for all of your
`4 declarations combined in the IPRs?
`5 A. No. I think if you combine the three
`6 declarations under the IPRs, it's probably closer
`7 to 70 hours.
`8 Q. Okay. And so is the 50 hours that you
`9 referenced, is that for the declaration on
`10 conception and reduction to practice?
`11 A. Yes.
`12 Q. Have you billed Medtronic for your time?
`13 A. I billed counsel.
`14 Q. How much have you billed counsel to date for
`15 your work on this matter?
`16 A. I don't have the total number, but my billing
`17 rate is $300 per hour.
`18 Q. Have you worked for Medtronic before?
`19 A. I have not.
`20 Q. Have you worked for counsel representing
`21 Medtronic before?
`22 A. No. The first time was 2019 in the district
`23 court matter.
`24 Q. Did you prepare for your deposition?
`25 A. Sorry?
`
`1 other expert witnesses in this case?
`2 A. No.
`3 Q. Have you spoken at any point with anybody
`4 else related to this case?
`5 A. No.
`6 Q. Have you spoken with anybody at all about
`7 this case, other than counsel?
`8 A. I've told my wife what I'm working on in a
`9 very general sense, but no details of the case.
`10 Q. Dr. Zalesky, before this lawsuit, were you
`11 aware of Vascular Solutions, the company Vascular
`12 Solutions, Inc.?
`13 A. Yeah. I seem to recall encountering them
`14 somewhere in the late 2000 time frame but not
`15 directly, just as either an exhibitor at a TCT
`16 meeting or something like that. But it was a very
`17 cursory observation or encounter. It wasn't
`18 really an encounter with any personnel or specific
`19 products.
`20 Q. Do you have any --
`21 THE VIDEOGRAPHER: Sorry. This is
`22 the videographer. I'm going to suggest that we
`23 try to remedy this -- the humming sound. It seems
`24 to be distracting. Should we go off the record
`25 and just try -- maybe try a couple different
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`1 things to fix this?
`2 MS. NORGARD: Yeah.
`3 THE WITNESS: Let me try remounting
`4 my laptop on some pad.
`5 THE VIDEOGRAPHER: We are going off
`6 the record. The time is 9:33.
`7 (Off the record.)
`8 THE VIDEOGRAPHER: We are back on
`9 the record. The time is 9:39.
`10 BY MS. NORGARD:
`11 Q. Dr. Zalesky, before we went off the record
`12 for some technical issues, we were talking about
`13 Vascular Solutions, Inc., the company, and I
`14 believe that you said that you had heard of
`15 Vascular Solutions, which I'll call VSI, but you
`16 weren't intimately familiar with them. You didn't
`17 use those words, but that's what I gathered; is
`18 that correct?
`19 A. Yes, that's correct.
`20 Q. Did you know how many products VSI had?
`21 A. No.
`22 Q. Were you aware of the GuideLiner product?
`23 A. Again, I think I encountered it, but
`24 potentially in a clinical setting but was not
`25 intimately familiar with it. Didn't examine it or
`
`1 A. Generally, yes.
`2 Q. What is your understanding?
`3 A. I believe it generates revenues in excess of
`4 tens of millions of dollars annually.
`5 Q. Are you aware that Teleflex purchased VSI, or
`6 Vascular Solutions, the company?
`7 A. Yes.
`8 Q. Do you know how much the purchase price was?
`9 A. I do not.
`10 Q. Have you ever heard that the purchase price
`11 was a billion dollars for Teleflex -- I'm sorry,
`12 for VSI?
`13 MS. ROBERG-PEREZ: Objection;
`14 foundation.
`15 THE WITNESS: No, I never -- I never
`16 really remember reading any account of the
`17 acquisition.
`18 BY MS. NORGARD:
`19 Q. Are you aware that the GuideLiner was a major
`20 factor in the billion-dollar valuation of VSI?
`21 MS. ROBERG-PEREZ: Objection;
`22 foundation.
`23 THE WITNESS: No. As I said, I just
`24 wasn't familiar with the whole acquisition
`25 process.
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`1 explore it.
`2 Q. Is the first time you became familiar with
`3 the GuideLiner in a more detailed manner when you
`4 were engaged for this dispute? In other words,
`5 back in October of 2019.
`6 A. Yes.
`7 Q. So you mentioned that you potentially had
`8 seen a GuideLiner in a clinical setting.
`9 Were you the person who was actually
`10 using the GuideLiner in that setting?
`11 A. No. I've been in the cardiac cath lab on
`12 many occasions to either observe or to provide
`13 some guidance on certain technologies, and in one
`14 of those clinical settings, I recall seeing a
`15 GuideLiner, but I didn't really go into any
`16 detail.
`17 Q. So in that clinical setting, you were
`18 observing somebody else using a GuideLiner; is
`19 that right?
`20 A. Yes.
`21 Q. Did you have any role in that procedure other
`22 than observation?
`23 A. No.
`24 Q. Are you aware of the commercial success of
`25 the GuideLiner?
`
`1 BY MS. NORGARD:
`2 Q. Would you agree that VSI was a successful
`3 company?
`4 A. From your description of acquisition by
`5 Teleflex, yes.
`6 Q. And they were successful even though they may
`7 not have followed the process that you would have
`8 liked to have seen for the development of the
`9 GuideLiner, right?
`10 A. As far as I know, yes.
`11 Q. Let's introduce, please, Exhibit 1755. And
`12 Dr. Zalesky, for this, we'll give the system just
`13 a moment to populate, and then you'll refresh
`14 again as you did last time.
`15 A. So you want to open 1755?
`16 Q. Correct.
`17 A. Okay.
`18 Q. Let me know when you have it, please.
`19 A. I have it.
`20 Q. Dr. Zalesky, is Exhibit 1755 the declaration
`21 that you submitted in these IPR proceedings on
`22 conception and reduction to practice?
`23 A. I'm just scrolling down to the signature
`24 page. I believe so.
`25 Q. And this declaration contains generally three
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`1 sections. There are numbered paragraphs on pages
`2 1 through 95.
`3 Do you agree with that? Do you see
`4 those on your screen?
`5 A. Yes.
`6 Q. And the paragraphs expand from paragraph 1 to
`7 paragraph 255.
`8 Do you see that?
`9 A. Yes.
`10 Q. And then the next part of your declaration is
`11 your CV; is that correct?
`12 A. Yes.
`13 Q. And that spans from pages 99 to 103; is that
`14 right?
`15 A. I believe so.
`16 Q. And by the way, on some of these pages, there
`17 are numerous numbers. The numbers that I'm
`18 referring to are those that are in the lower
`19 right-hand corner of the page.
`20 Do you see that?
`21 A. Okay.
`22 Q. And then the third party of your declaration
`23 is labeled Appendix A, and there are a number of
`24 claim charts.
`25 Do you see those?
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`1 A. Yes.
`2 Q. What does it mean for a medical device
`3 invention to work for its intended purpose?
`4 A. Early in the pre-development phase of a
`5 product, there's a clinical need that's addressed,
`6 and that is typically stated as an
`7 indicated-for-use in ultimate packaging and
`8 labeling of the product.
`9 So that perspective or that clinical
`10 need is the driver for the design and the
`11 development of the products.
`12 The burden to demonstrate that, of
`13 course, is to actually build a device and test it
`14 for its intended purpose in either an actual or
`15 simulated clinical environment, and make the
`16 necessary measurements that demonstrate that, in
`17 fact, it did meet its intended use.
`18 Q. What are the necessary measurements that are
`19 made to demonstrate it works for its intended use?
`20 A. That depends precisely on the intended use.
`21 In the event of a catheter -- an
`22 intracoronary catheter intended for certain
`23 procedures or certain applications, there are some
`24 standard requirements, obviously, safety, safety,
`25 safety, meaning it doesn't decompose or shred
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`Page 29
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`1 A. Yes.
`2 Q. And Appendix A of your declaration spans from
`3 pages 104 to 286.
`4 Do you see that?
`5 A. Yes.
`6 Q. And there are a number of exhibits that are
`7 referenced throughout your report, this
`8 Exhibit 1755, correct?
`9 A. Yes.
`10 Q. Are there any other opinions on conception
`11 and reduction to practice of yours that are not
`12 included in this declaration?
`13 A. No.
`14 Q. So in other words, this declaration contains
`15 all of your opinions on conception and reduction
`16 to practice as it relates to this matter; is that
`17 correct?
`18 A. Yes.
`19 Q. Is there any other evidence on conception and
`20 reduction to practice that you've considered that
`21 is not in this declaration?
`22 A. No.
`23 Q. Dr. Zalesky, in order to reduce to practice,
`24 the device has to be shown to work for its
`25 intended purpose, correct?
`
`1 material, shed material, it doesn't interfere or
`2 otherwise threaten or create damage.
`3 And then there are performance
`4 measures. Can you actually put the device where
`5 you want to? Can you position it? Can you make
`6 it perform whatever its intended use is? And
`7 those tests range from simple things like
`8 flexibility to insertability, torquability, and
`9 other parameters.
`10 Q. In order to show a medical device works for
`11 its intended purpose in patentability sense, does
`12 safety have to be proven?
`13 A. I was thinking in the broader sense. I can't
`14 remember not addressing safety as part of that
`15 thought process.
`16 In terms of patent law, I suspect
`17 safety is not a critical consideration, but I
`18 don't honestly know the answer to that.
`19 Q. So you don't know whether safety is required
`20 to be shown to show that a device, a medical
`21 device works for its intended purpose, right? You
`22 just don't know one way or another?
`23 A. I don't know the relevant patent law
`24 requirement. I know from my experience that if
`25 there was a safety issue, that -- to me that would
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`1 be a problem that would halt the development and
`2 the reduction of practice.
`3 Q. So it's your opinion that safety of a medical
`4 device must be shown in order for it to be reduced
`5 to practice in the patentability sense; is that
`6 right?
`7 MS. ROBERG-PEREZ: Objection;
`8 mischaracterizes testimony.
`9 THE WITNESS: I believe so, in the
`10 sense that I don't know how you could demonstrate
`11 something is, in fact, performing its intended use
`12 if it's not safe because the intended use would
`13 include a safe procedure.
`14 BY MS. NORGARD:
`15 Q. So to show a medical device works for its
`16 intended purpose, it's your opinion that the
`17 device has to be tested and shown to be safe,
`18 correct?
`19 A. To some extent, yes.
`20 Q. Who defines the intended purpose of an
`21 invention?
`22 A. Typically the inventor.
`23 Q. Is there an atypical situation?
`24 A. Oftentimes an inventor will respond to a
`25 clinical need, either via the literature or actual
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`Page 31
`1 case observations, and he or she may mimic that
`2 input for the intended use.
`3 Q. Who defines whether the device works for its
`4 intended purpose?
`5 A. To me the burden is on the inventor.
`6 Q. So if the inventor believes the device works
`7 for its intended purpose, that meets the test?
`8 A. It's a bit more than that.
`9 The inventor, in order to believe
`10 that, needs to have some evidence that it works
`11 for its intended use.
`12 Q. What evidence?
`13 A. The fabrication and use of at least a
`14 prototype device in a simulated setting.
`15 MS. ROBERG-PEREZ: Before you go on
`16 to your next question, I don't want Dr. Zalesky to
`17 have to hold his phone up the entire day. Can you
`18 hear him if he puts his phone down on a surface?
`19 MS. NORGARD: Sure.
`20 MS. ROBERG-PEREZ: Paul, can you say
`21 something?
`22 THE WITNESS: I'm here.
`23 MS. ROBERG-PEREZ: That sounds okay
`24 to me. Tara, can you hear him?
`25 MS. NORGARD: I can. And if anybody
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`1 loses his volume, we'll take a break and we'll
`2 address it.
`3 BY MS. NORGARD:
`4 Q. Dr. Zalesky, does an expert have to concur
`5 that a device works for its intended purpose?
`6 A. I don't really understand that question.
`7 Q. Well, you said it's on -- the burden is on
`8 the inventor in terms of defining whether the
`9 device works for its intended purpose, right?
`10 A. Right.
`11 Q. And it's the inventor's belief or
`12 understanding that the device works for its
`13 intended purpose that controls the analysis,
`14 right?
`15 MS. ROBERG-PEREZ: I'm going to
`16 object on the grounds that this calls for a legal
`17 conclusion.
`18 MS. NORGARD: That's not an
`19 appropriate objection in this context, Ms. Perez.
`20 Please stick to the trial practice guides.
`21 BY MS. NORGARD:
`22 Q. Can you answer the question, please?
`23 A. Please ask the question again.
`24 MS. NORGARD: Paula, could you
`25 please repeat it.
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`1 (The preceding question was read by
`2 the court reporter.)
`3 MS. ROBERG-PEREZ: Objection, form.
`4 THE WITNESS: I don't really know
`5 what that means in terms of "controls the
`6 analysis."
`7 As a special expert, I was asked to
`8 opine on the actual conception of the device
`9 leading to the patent.
`10 BY MS. NORGARD:
`11 Q. That wasn't my question, Dr. Zalesky.
`12 You earlier testified that it is the
`13 inventor's belief about intended purpose that
`14 controls, did you not?
`15 A. That --
`16 MS. ROBERG-PEREZ: Objection; form.
`17 THE WITNESS: -- drives it, correct.
`18 Yes, that drives it. That's not what I'm hearing
`19 your second question to be, though.
`20 The intended use drives the need to
`21 then demonstrate that it satisfies the intended
`22 use.
`23 BY MS. NORGARD:
`24 Q. Does the device have to work perfectly in
`25 order to be found to work for its intended
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`1 purpose?
`2 A. I'm not sure "perfectly" is the term I would
`3 use. It needs to work adequately.
`4 Q. And who determines whether it's working
`5 adequately?
`6 A. Well, the data speaks for itself. There are
`7 certain criteria that are common to the industry.
`8 If you work in the coronary catheter business, for
`9 instance, in general, you know the anatomical
`10 requirements to use devices in the coronary
`11 vasculature, and those are extremely well known
`12 and well published, even with standards.
`13 Q. Is there a certain number of prototypes that
`14 have to be built to show that a medical device
`15 works for its intended