`
`2
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`16
`17
`18
`19
`
`20
`
`21
`
`22
`23
`24
`25
`
`Page 1
`
` 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
` GREGG SUTTON
`
`DATE: November 6, 2020
`
`TIME: 8:55 a.m. Central Time
`
`PLACE: Veritext Virtual Videoconference
`
`REPORTED BY: PAULA K. RICHTER, RMR, CRR, CRC
` (By videoconference)
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Page 1
`
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex.1757
`Medtronic v. Teleflex
`
`
`
`Page 2
`
`Page 4
`
`1 INDEX
`
`2 3
`
`WITNESS: GREGG SUTTON PAGE:
`4 EXAMINATION BY MS. TREMBLAY................ 6
`5 EXAMINATION BY MS. NORGARD................. 82
`
`6 7 8
`
`EXHIBITS PREVIOUSLY MARKED AND REFERRED TO:
`9 EXHIBIT 1108 U.S. Patent 7,604,612 -
`10 Ressemann Patent............... 8
`11 EXHIBIT 1109 U.S. Patent 5,439,445 -
`12 Kontos Patent.................. 59
`13 EXHIBIT 2002 Lab Notebook 83................ 54
`14 EXHIBIT 2005 GuideLiner Send Report......... 67
`15 EXHIBIT 2119 Declaration of Gregg Sutton.... 45
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1 APPEARANCES
`2 ON BEHALF OF THE PETITIONERS (By videoconference):
`3 Ms. Emily J. Tremblay, Esq.
`4 Ms. Sharon Roberg-Perez, Esq.
`5 Mr. Cyrus A. Morton, Esq.
`6 ROBINS KAPLAN, LLP
`7 800 LaSalle Avenue, Suite 2800
`8 Minneapolis, Minnesota 55401
`9 (612) 349-8500
`10 etremblay@robinskaplan.com
`11 sroberg-perez@robinskaplan.com
`12 cmorton@robinskaplan.com
`13
`14 ON BEHALF OF THE PATENT OWNER (By videoconference):
`15 Ms. Tara C. Norgard, Esq.
`16 Mr. Alexander S. Rinn, Esq.
`17 Mr. Derek Vandenburgh, Esq.
`18 CARLSON, CASPERS, VANDENBURGH & LINDQUIST
`19 225 South Sixth Street, Suite 4200
`20 Minneapolis, Minnesota 55402
`21 (612) 436-9600
`22 tnorgard@carlsoncaspers.com
`23 arinn@carlsoncaspers.com
`24 dvandenburgh@carlsoncaspers.com
`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 8:55 a.m. on November
`4 6th, 2020.
`5 This is Media Unit 1 of the
`6 video-recorded deposition of Gregg Sutton taken by
`7 counsel for the petitioner in the matter of
`8 Medtronic, Inc., et al. versus Teleflex
`9 Innovations, filed in the U.S. Patent and
`10 Trademark Office; Case Number IPR2020-00126.
`11 My name is Tim Perry, certified
`12 legal video specialist. The court reporter is
`13 Paula Richter.
`14 Counsel, will you identify
`15 yourselves for the record, please.
`16 MS. TREMBLAY: Good morning. This
`17 is Emily Tremblay with Robins Kaplan. Also with
`18 me from Robins Kaplan are Cy Morton and Sherry
`19 Roberg-Perez. Also on the line is our expert,
`20 Paul Zalesky.
`21 MS. NORGARD: Good morning. This is
`22 Tara Norgard, and with me today is Alex Rinn. We
`23 are both appearing with the Carlson Caspers law
`24 firm on behalf of the patent owner and the
`25 witness.
`
`1 APPEARANCES (Continued)
`
`23
`
`ALSO PRESENT:
`4 Tim Perry - Videographer
`5 Dina Martin - Veritext Concierge
`6 Paul Zalesky
`7 Greg Smock - Teleflex
`
`89
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`2 (Pages 2 - 5)
`
`888-391-3376
`
`Page 2
`
`
`
`Page 6
`1 THE VIDEOGRAPHER: Okay. Thank you.
`2 Please swear in the witness.
`3 GREGG SUTTON,
`4 duly sworn, was examined and testified as follows:
`5 EXAMINATION
`6 BY MS. TREMBLAY:
`7 Q. Good morning, Mr. Sutton.
`8 A. Good morning.
`9 Q. Could you please state your full name for the
`10 record and spell your last name.
`11 A. Gregg Stuart Sutton, last name is
`12 S-U-T-T-O-N.
`13 Q. My name is Emily Tremblay. I'm an attorney
`14 with Robins Kaplan and I'm here representing
`15 Medtronic, Inc., and Medtronic Vascular, Inc.
`16 You've given a deposition before, Mr. Sutton; is
`17 that correct?
`18 A. Yes, I believe so.
`19 Q. Well, I'm just going to go over a few basic
`20 ground rules as a refresher. Please feel free to
`21 ask questions.
`22 So today I'm going to be asking you
`23 a series of verbal questions and you will do your
`24 best to answer them truthfully and completely and
`25 verbally. The court reporter can't record a head
`
`Page 7
`1 nod or a head shake or hand gestures. We're going
`2 to do our best to speak one at a time and not over
`3 each other, again, for the benefit of the court
`4 reporter as she records what we're saying.
`5 And because we're remote, I'm going
`6 to ask if there's anyone in the room with you
`7 today?
`8 A. No, there is not.
`9 Q. Over the course of today, if you don't
`10 understand one of my questions, please ask me to
`11 clarify or to rephrase. I will assume that if you
`12 do answer my question, you've heard it and you
`13 understood it. Is that fair?
`14 A. That's fair.
`15 Q. We'll be taking breaks, but if you need one
`16 or want one before we take one, please just let me
`17 know. I will only ask that if I've asked you a
`18 question, that you answer it before we take a
`19 break so that we don't leave a question pending on
`20 the record. Do you understand?
`21 A. I do.
`22 Q. Have you consumed any alcohol today?
`23 A. No, I have not.
`24 Q. Have you taken any controlled substances or
`25 prescription medication?
`
`Page 8
`
`1 A. No, I have not.
`2 Q. Is there any reason that you will not be able
`3 to understand my questions and answer truthfully
`4 and completely today?
`5 A. No reasons.
`6 Q. Do you have any questions before we begin?
`7 A. No, I don't.
`8 Q. What did you do to prepare for your
`9 deposition today? And before you answer, I'm not
`10 interested in any advice that you may have
`11 received from your attorneys.
`12 A. What did I do today?
`13 Q. Well, to prepare for today.
`14 A. I reviewed my declaration that was entered in
`15 September.
`16 Q. Did you speak with anyone other than your
`17 attorneys?
`18 A. No.
`19 Q. Did you review any documents other than your
`20 declaration that you just mentioned?
`21 A. No, I did not.
`22 Q. Did you do anything else other than review
`23 your declaration in anticipation of today?
`24 A. No.
`25 Q. Mr. Sutton, I'm going to move an exhibit into
`
`Page 9
`
`1 the Marked Exhibits folder. It will be titled
`2 Exhibit 1108. Do you see it?
`3 A. I do.
`4 Q. Will you please open that exhibit?
`5 MS. NORGARD: If you could hold on
`6 one moment.
`7 MS. TREMBLAY: Oh, sure.
`8 MS. NORGARD: I don't have it yet.
`9 And I think that's because I'm in the wrong
`10 folder.
`11 THE WITNESS: I see it, but I can't
`12 really read it.
`13 MS. TREMBLAY: And there is a
`14 zoom-in feature towards the bottom of the page, if
`15 that helps too. I'm going to give your counsel a
`16 moment to make sure that she can pull it up too.
`17 MS. NORGARD: 1108?
`18 MS. TREMBLAY: Yes.
`19 MS. NORGARD: Thank you.
`20 BY MS. TREMBLAY:
`21 Q. Great. So Mr. Sutton, do you recognize
`22 Exhibit 1108?
`23 A. No, I don't.
`24 Q. If you are able to zoom in using the feature
`25 towards the bottom of the screen, you'll see that
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`3 (Pages 6 - 9)
`
`888-391-3376
`
`Page 3
`
`
`
`Page 10
`1 this is titled "Gregg Sutton from 6/20/2018," and
`2 this is a transcript of a deposition that you've
`3 given previously.
`4 Does that refresh your recollection?
`5 A. Yes, only that I read the attorney,
`6 Thomas Vitt, on top.
`7 Q. And you'll see towards the left -- the top
`8 left corner of the first page is the case caption.
`9 It provides QXMedical, LLC versus Vascular
`10 Solutions, LLC, Teleflex Innovations S.A.R.L., and
`11 Arrow International. So that would have been the
`12 case that this deposition was given in. Do you
`13 recall that?
`14 A. I do.
`15 Q. So do you remember giving this deposition?
`16 A. Yes, I do.
`17 Q. And you swore an oath prior to giving this
`18 deposition similar to today; is that correct?
`19 A. That's correct.
`20 Q. In which you swore to tell the truth; is that
`21 correct?
`22 A. That's correct.
`23 Q. And you testified truthfully here when you
`24 gave this deposition; is that correct?
`25 A. I did.
`
`Page 11
`1 MS. TREMBLAY: You can set Exhibit
`2 1108 to the side. We may come back to that later.
`3 BY MS. TREMBLAY:
`4 Q. I'd like to talk a little bit about your
`5 background. So, Mr. Sutton, what do you currently
`6 do for work?
`7 A. I don't. I retired in February, March time
`8 frame.
`9 Q. Congratulations. What did you do before your
`10 retirement?
`11 A. I had a position as a vice president of
`12 research and development at SurModics,
`13 Incorporated.
`14 Q. And could you briefly describe what SurModics
`15 did?
`16 A. SurModics is a surface coatings company for
`17 medical devices.
`18 Q. You said you -- oh, sorry, go ahead.
`19 A. Sorry. And also was getting into medical
`20 device technology development.
`21 Q. And you said that you were VP of research and
`22 development there; is that correct?
`23 A. That's correct.
`24 Q. And how long were you at SurModics?
`25 A. Four years and two months.
`
`Page 12
`
`1 Q. And before SurModics, where were you
`2 employed?
`3 A. NorMedix, Incorporated.
`4 Q. And what was your position with NorMedix?
`5 A. I was the CEO, owner.
`6 Q. And is that also a medical device company?
`7 A. Yes.
`8 Q. And what year did you found NorMedix?
`9 A. It's either 2009 or '10.
`10 Q. Fine. A rough approximation. Just trying to
`11 get a sense of your background.
`12 A. Sure.
`13 Q. So before you founded NorMedix in the 2009,
`14 2010 time frame, where were you working?
`15 A. Before I founded that, I was at -- back at
`16 Atritech, Inc.
`17 Q. What was your role at that time?
`18 A. Also vice president, research and
`19 development.
`20 Q. And then assuming that Atritech was also a
`21 medical device company; is that correct?
`22 A. Yes, ma'am.
`23 Q. And before Atritech, where were you?
`24 A. Vascular Solutions.
`25 Q. All right. So we've arrived at VSI. And did
`
`Page 13
`
`1 you join VSI in 2004; is that correct?
`2 A. That's correct.
`3 Q. Do you know about what month you joined VSI
`4 in 2004?
`5 A. I think it was late, probably in the fall,
`6 September, October of 2004.
`7 Q. And you joined VSI as vice president of
`8 research and development; is that correct?
`9 A. That is correct.
`10 Q. Did you remain in that role until you left?
`11 A. Yes.
`12 Q. To whom did you report in that role?
`13 A. Mr. Howard Root.
`14 Q. And what was his title at Vascular Solutions?
`15 A. He was the chief executive officer.
`16 Q. And in your role as vice president, research
`17 and development, how many people reported to you,
`18 about?
`19 A. It ranged from when I started to when I left,
`20 from probably 10 to 15.
`21 Q. About 10 when you started, growing to 15 when
`22 you left; is that correct?
`23 A. Approximately, yes.
`24 Q. And when did you leave Vascular Solutions?
`25 A. I believe it was in June of 2006.
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`4 (Pages 10 - 13)
`
`888-391-3376
`
`Page 4
`
`
`
`Page 14
`1 Q. Is that the R&D department then that we're
`2 talking about when we're talking about 10 to 15
`3 people?
`4 A. Yes, ma'am.
`5 Q. And why did you leave VSI in June 2006?
`6 A. I don't recall specifically.
`7 Q. And I know this is going back a ways, but
`8 where were you before you joined VSI in fall 2004?
`9 A. Atritech, Incorporated.
`10 Q. So you had been at Atritech previously before
`11 you joined as vice president of research and
`12 development; is that correct?
`13 A. That's correct, starting in 2000.
`14 Q. And what was your role in 2000 at Atritech?
`15 A. I was a founder and VP, R&D, co-founder.
`16 Q. Could you please describe your educational
`17 background?
`18 A. Sure. I have a mechanical engineering degree
`19 from the University of Minnesota. I graduated in
`20 1986, I believe -- no, '85.
`21 Q. Do you have any other degrees?
`22 A. No.
`23 Q. Any specific specialized training?
`24 A. No. Not other than, you know, my experience
`25 in the med tech industry.
`
`Page 15
`
`1 Q. I'd like to talk about your role as vice
`2 president of research and development when you
`3 were at VSI. What were some of your
`4 responsibilities in that role?
`5 A. Well, generally, to oversee all activities in
`6 research and development in terms of product
`7 innovation and development, oversee the management
`8 of the people involved under my -- in my staff,
`9 and, you know, help bring products to market.
`10 Q. So what does bringing a product to market
`11 involve specifically? I'm wondering if you can
`12 talk about the type of work that you were
`13 performing.
`14 A. In my role, it is confined to device
`15 inventing, developing, and preparing for
`16 manufacturing.
`17 Q. What kind of -- you said your role
`18 specifically involved advice, inventing. What
`19 kind of work did you oversee others perform in the
`20 R&D department?
`21 A. Well, most of my staff was engineering --
`22 engineers at various levels and technicians, and,
`23 you know, so they did the -- all the work product
`24 and device development.
`25 Q. I'd like to get a better sense of the levels
`
`Page 16
`1 of experience and roles in the R&D department.
`2 You mentioned engineers of various levels and
`3 technicians. Could you briefly describe, kind of,
`4 each of those job titles within the R&D department
`5 and a sense of what roles each held?
`6 A. So you want me to break down engineering into
`7 levels or -- I'm not sure what you're asking.
`8 Q. Well, let me ask you this: Are the main
`9 buckets in the R&D department, are they engineers
`10 and technicians; is that correct?
`11 A. That's correct.
`12 Q. Could you tell me a little bit about what the
`13 engineers are doing in terms of new product
`14 development?
`15 A. They are -- they're basically conducting
`16 anywhere from early stage concept and design work,
`17 building prototypes, testing prototypes, creating
`18 CAD-generated drawings, writing specifications.
`19 You know, those are generally what they're working
`20 on.
`21 Q. What about the technicians? What type of
`22 work were they typically doing and how did that
`23 differ from the work that you just described the
`24 engineers doing?
`25 A. Well, they're carrying specific tasks under
`
`Page 17
`1 the direction of mainly the engineers, including,
`2 you know, building prototypes, testing prototypes,
`3 procuring materials, things like that.
`4 Q. So you mentioned obviously a big part of R&D
`5 is product innovation and development. How did
`6 you typically track the development of a new
`7 product?
`8 A. I'm not sure what you're asking. You're
`9 asking plans for development or are you talking
`10 about results of development?
`11 Q. Let me rephrase. Were there typically phases
`12 of, like, new product development, you know, kind
`13 of big picture, were there are phases that a new
`14 product would move through over the course of its
`15 development?
`16 A. I don't recall specifically if we had phases,
`17 but in general, yes.
`18 Q. And how were you typically -- were there
`19 benchmarks or other ways that you tracked
`20 development? I'm just trying to get a sense of
`21 your system as VP of R&D and how you typically
`22 monitored the progress of new product development.
`23 A. Well, generally we had a -- we would track a
`24 project using, you know, a management software and
`25 have basically phases and milestones and
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`5 (Pages 14 - 17)
`
`888-391-3376
`
`Page 5
`
`
`
`Page 18
`1 deliverables for each phase, you know, listed out
`2 on the project management software. And, you
`3 know, that's generally how we tracked projects.
`4 Q. Okay. How many people were typically working
`5 on a new project at a given time?
`6 A. Well, generally an engineer is assigned a
`7 given project, and so it's usually an engineer and
`8 then a technician or two on a given project with,
`9 you know, some level of oversight from myself and
`10 perhaps others.
`11 Q. And was Jeff Welch a member of the R&D
`12 department during your time at VSI?
`13 A. Yes.
`14 Q. And what role did he hold in the department?
`15 A. He had a -- he was -- I can't remember if
`16 it's a manager or director of engineering role.
`17 Q. Okay. So would he have been working on the
`18 new projects, like the engineers, or more in an
`19 oversight role similar to yourself?
`20 A. Both, actually. You know, he -- I believe,
`21 if I recall correctly, he probably was working
`22 heavily on a couple projects, but also overseeing
`23 several others because he had engineers reporting
`24 to him as well.
`25 Q. Did your engineers or other individuals in
`
`Page 20
`1 Q. When you were working on developing a new
`2 project, about how often do you think you would
`3 hold meetings related to that project?
`4 A. It probably -- you know, I don't really
`5 remember, but it would have varied depending on
`6 the project. Once every month, twice a month
`7 maybe.
`8 Q. I'd like to talk about you specifically. Did
`9 you, personally keep records or other written or
`10 electronic documents in your role?
`11 A. I mean, sure. I had a whole, you know,
`12 computer that had files on it.
`13 Q. And what kind of records would you keep in
`14 your role as VP of R&D?
`15 A. Well, any work product documentation, project
`16 planning, e-mails, reports.
`17 Q. And would these be records specific to
`18 certain projects?
`19 A. Sure, yeah.
`20 Q. I'm just trying to get a sense of, kind of,
`21 what notes or records you were keeping for a
`22 specific new project as it was under development.
`23 Were you relying on your engineers to keep testing
`24 notes or did you keep testing notes?
`25 A. My engineers would be keeping detailed notes
`
`Page 19
`1 the R&D department typically work on more than one
`2 project at a time?
`3 A. Yes. In those days, I believe that's
`4 correct.
`5 Q. Did you kind of assign those projects to the
`6 engineers, or how did you manage work allocation?
`7 A. I believe I generally directed project
`8 responsibility.
`9 Q. Did you determine which projects received
`10 priority over others?
`11 A. Not really, no.
`12 Q. Would that have been Mr. Root's role in terms
`13 of prioritizing projects?
`14 A. Yes.
`15 Q. As VP of R&D, did you hold regular meetings
`16 with your department?
`17 A. I held meetings. I'm not -- I don't recall
`18 how regular they were.
`19 Q. Did you have meetings specific to certain
`20 projects?
`21 A. Definitely, yes.
`22 Q. Would someone have been keeping meeting
`23 minutes or notes during those meetings?
`24 A. I don't recall. Perhaps, but I just can't
`25 say yes or no. I don't remember.
`
`Page 21
`
`1 like that.
`2 Q. Did you track new project development work?
`3 Did you have a document to, kind of, track
`4 progress on a specific project?
`5 A. Yeah. I think I answered that already. I
`6 did.
`7 Q. How often would you update your notes on a
`8 specific project?
`9 A. You know, I don't remember. My practice was
`10 every week or so.
`11 Q. Did you provide your engineers and others in
`12 the R&D department specific instructions about
`13 keeping notes related to project development?
`14 A. I'm sorry. Could you repeat the question?
`15 Q. Sure. Did you give the engineers or others
`16 in the research and development department
`17 specific instructions regarding keeping notes on
`18 new project development?
`19 A. I don't remember anything specific on that.
`20 Q. Did VSI have any specific policies about
`21 tracking inventions or new projects?
`22 A. Yeah, I just don't remember. You know, it's
`23 a long time ago.
`24 Q. That's fair. Did you have any reporting
`25 obligations to either Mr. Root or your board of
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`6 (Pages 18 - 21)
`
`888-391-3376
`
`Page 6
`
`
`
`Page 22
`
`Page 24
`
`1 directors, periodic reports that you'd have to
`2 give?
`3 A. Yes.
`4 Q. About how often would that be?
`5 A. Well, I don't remember specifically, but
`6 let's say the board, you know, probably met every
`7 quarter, so every quarter I'd prepare at least the
`8 R&D section of, you know, the report to the board.
`9 Q. And you would agree that records related to
`10 new project development are important, correct?
`11 A. Sure. I'm not sure what kind of records
`12 you're talking about, but . . .
`13 Q. Well, just the kind that we've been
`14 discussing. Just tracking new project
`15 development, anything related to the work that
`16 your department is doing related to a new project.
`17 A. Sure.
`18 MS. NORGARD: Object to the form.
`19 BY MS. TREMBLAY:
`20 Q. And would you agree that records specifically
`21 related to the conception or reduction to practice
`22 with a new invention are important?
`23 A. Yes.
`24 Q. Were there occasions during your time at VSI
`25 in which work performed in the R&D department was
`
`1 Q. Sure. So --
`2 A. And it depends on -- you know, my involvement
`3 in that varied depending on what product
`4 innovation it was.
`5 Q. So if you were the named inventor for a
`6 particular innovation, about how frequently would
`7 you communicate with patent counsel during the
`8 patenting process?
`9 A. Well, there just weren't that many examples
`10 of being the named inventor that I recall, but
`11 I -- as my role of R&D, vice president, I met with
`12 the patent counsel on a regular basis. I can't
`13 remember if it was monthly or quarterly, but
`14 generally, you know, once every two or three
`15 months, just with Mr. Root to get an update on
`16 that occasion and progress and anything else
`17 related to intellectual property matters.
`18 Q. Understood. I'd like to get a sense of
`19 project expenditures during this time period. So
`20 on average, about how much would the R&D
`21 department spend working on developing a new
`22 product over a quarter?
`23 A. I really don't recall that. I can tell you
`24 what generally we were -- I mean, I just don't
`25 remember. I mean, I know how much back then it
`
`Page 23
`
`Page 25
`
`1 patented?
`2 A. Could you repeat that again?
`3 Q. Sure. I'm wondering if there were occasions
`4 during your time at VSI in which the work that the
`5 R&D department was doing was patented?
`6 A. Well, the work that they were doing wasn't
`7 patented, but some ideas and concepts might have
`8 been patented.
`9 Q. Yeah. Let me -- yeah. Let me rephrase.
`10 That was an unartful question.
`11 Were the devices and projects they
`12 were working on patented?
`13 A. The devices were in a few locations.
`14 Q. And what did that process involve?
`15 A. Back then, to the best of my recollection,
`16 there wasn't a process.
`17 Q. Would you work with patent counsel?
`18 A. I mean, yes.
`19 Q. You, personally would work with patent
`20 counsel?
`21 A. It depended on -- in my recollection, it was
`22 never the same, so it depended on the device
`23 invention. For instance, you know, the GuideLiner
`24 started out one way. Another invention might have
`25 started out a different way.
`
`1 generally cost to get a device from zero to
`2 submission of a 510(k).
`3 Q. About how much was that?
`4 A. It was generally between, you know, a million
`5 to, you know, over a million dollars.
`6 Q. And over what time frame would that spend
`7 typically occur, from zero to 510(k) as you said?
`8 A. It -- you know, it depended on the project.
`9 There was --
`10 Q. Is there an average time?
`11 A. Some were six months. Some were three years
`12 or more. But I was only there for less than two
`13 years, so . . .
`14 Q. Fair. So during your time at VSI, was the
`15 company private?
`16 A. No. I believe -- it was a public company.
`17 Q. I'd like to talk a little bit about the
`18 specific projects that the R&D department was
`19 working on during your time at VSI. So do you
`20 recall what some of the projects that you worked
`21 on were?
`22 A. You mean that I oversaw?
`23 Q. Let's start with any that you maybe directly
`24 worked on. Were there any projects that you were
`25 directly working on during your time at VSI?
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`7 (Pages 22 - 25)
`
`888-391-3376
`
`Page 7
`
`
`
`Page 26
`
`Page 28
`
`1 A. Well, other than, say, an inventive role or
`2 direction, there was no projects that I directly
`3 worked on.
`4 Q. Now let's move to overseeing. What projects
`5 were you overseeing during this time, from fall
`6 2004 to June 2006?
`7 A. Well, there's many projects, so I don't
`8 really remember. But the ones I do remember would
`9 have been next-generation Pronto, Twin-Pass.
`10 Yeah. Those are the only ones that come to mind.
`11 Langston.
`12 THE COURT REPORTER: I didn't hear
`13 your whole answer, I apologize. After that --
`14 after Langston.
`15 THE WITNESS: Sorry. Pronto -- the
`16 next-generation Pronto device. There's a Langston
`17 device. There was a --
`18 THE COURT REPORTER: I'm sorry. I
`19 have to stop you. We're getting some
`20 interference. It's cutting your testimony out.
`21 Is anyone else hearing that?
`22 THE VIDEOGRAPHER: I'm hearing it as
`23 well. It goes away when someone speaks, but...
`24 MS. TREMBLAY: I'm not getting
`25 anything now.
`
`Page 27
`1 THE WITNESS: I don't hear anything
`2 now.
`3 BY MS. TREMBLAY:
`4 Q. Let me re-ask the question, Mr. Sutton, just
`5 so we reorient ourselves.
`6 So you were discussing the projects
`7 that you were overseeing during your time at VSI,
`8 and I believe you identified a next-generation
`9 Pronto; is that correct?
`10 A. Yes. Pronto, Twin-Pass, GuideLiner. There
`11 was a Langston device. Those are the ones that I
`12 remember.
`13 Q. Does Skyway ring a bell? Were you working on
`14 a project called Skyway?
`15 A. Yeah, that's Skyway, Twin-Pass, kind of the
`16 same flavor.
`17 Q. To the extent you remember, let's talk about
`18 maybe some of the key materials that you were
`19 using for each of these projects. Do you remember
`20 what materials or components were used for the
`21 Pronto next generation development?
`22 MS. NORGARD: Excuse me. This is
`23 beyond the scope. Objection.
`24 BY MS. TREMBLAY:
`25 Q. You can answer, Mr. Sutton.
`
`1 A. I don't really remember specific materials.
`2 Q. What about the Langston catheter that you
`3 mentioned?
`4 A. What materials?
`5 Q. Yes.
`6 A. Yeah. I -- I mean, I know what materials I
`7 used in medical devices like that, but I don't
`8 remember specifically what the --
`9 Q. Understood. What about Twin-Pass Skyway?
`10 A. Same thing. I don't recall what specific
`11 material was used.
`12 Q. What about -- I believe GuideLiner was the
`13 last one that you mentioned. What about
`14 GuideLiner? Do you remember any of the specific
`15 components used for GuideLiner?
`16 A. Yes, I do.
`17 Q. And why do you remember the components for
`18 GuideLiner, but not Pronto or the others that you
`19 identified?
`20 A. Well, because my memory has been somewhat
`21 refreshed lately, it was one of my inventions, so
`22 I was -- I'm just more in tune to that one.
`23 Q. What about any early concept or exploration
`24 projects? Do you remember working on any of those
`25 during your time from fall 2004 to June 2006?
`
`Page 29
`1 A. What's your definition of early exploration?
`2 Q. Yes. I'm wondering if there are other
`3 projects that maybe didn't have a name, like the
`4 Pronto or the Langston, that you were able to
`5 identify if there was another category that you
`6 remember working on?
`7 A. I don't remember.
`8 Q. Let's talk more specifically about
`9 GuideLiner. So what is the GuideLiner guide
`10 extension catheter?
`11 A. It's a guide catheter invention device that
`12 is used to help provide more backup support for,
`13 you know, interventional cases, PCI cases.
`14 Q. I'm sorry. PCI cases?
`15 A. PCI, coronary angioplasty and stenting cases.
`16 Q. So what is the GuideLiner rapid exchange
`17 guide extension catheter?
`18 A. Well, it's a device to provide backup support
`19 for PCI cases, like I mentioned, and a method of
`20 entry into the body uses what is typically, these
`21 days, is using standard guidewire because the
`22 GuideLiner had a rapid exchange lumen in it.
`23 Q. And what about the GuideLiner over-the-wire
`24 guide extension catheter? How is that different
`25 than the rapid exchange?
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`8 (Pages 26 - 29)
`
`888-391-3376
`
`Page 8
`
`
`
`Page 30
`
`Page 32
`
`1 A. That was a version of the device that was not
`2 rapid exchange, so it was -- it was just, like,
`3 another guide catheter without the distal
`4 curvatures.
`5 Q. And during your time at VSI, you were working
`6 to develop both versions of the GuideLiner; is
`7 that correct, both the rapid exchange and the
`8 over-the-wire version?
`9 A. That's what I remember, yes.
`10 Q. Do you remember when you began working on the
`11 GuideLiner device? Let's start with the rapid
`12 exchange version.
`13 A. I do. It was early in 2005.
`14 Q. If you could estimate what percentage of your
`15 time was devoted to the GuideLiner rapid exchange
`16 after January of 2005?
`17 A. Versus what?
`18 Q. Versus everything else that was on your plate
`19 as VP of R&D. What percentage of your time did
`20 you allocate to the GuideLiner rapid exchange?
`21 A. I could only estimate.
`22 Q. Was it less than 50 percent?
`23 A. Definitely. Less than 25 percent.
`24 Q. Less than 10 percent?
`25 A. Perhaps. But I don't remember specifically.
`
`1 A. Sure, yes.
`2 Q. So was the company prioritizing the
`3 over-the-wire version because of its development
`4 timeline?
`5 A. I don't think they were -- I don't believe --
`6 I don't recall that we were prioritizing the
`7 over-the-wire version.
`8 Q. But the company was working on an
`9 over-the-wire version despite your previous
`10 statements about physician preference; is that
`11 correct?
`12 A. My recollection, it was kind of an option, a
`13 backup plan.
`14 Q. And as an option or a backup plan, was it
`15 being developed in the same time period from
`16 January 2005 on?
`17 A. Yeah. To be clear -- to be clear, I don't
`18 recall personally spending any time on the
`19 over-the-wire version.
`20 Q. Understood. Do you know -- oh.
`21 A. I'm back.
`22 Q. No worries. So --
`23 THE WITNESS: I do have a body in
`24 the room now, my dog, so just --
`25 MS. TREMBLAY: I think we'll allow
`
`Page 31
`
`Page 33
`
`1 Q. Okay. Less than 5 percent?
`2 A. I don't know.
`3 Q. Now it's unclear? Okay.
`4 What about GuideLiner over-the-wire?
`5 When did you begin working on that version of the
`6 device?
`7 A. I don't remember much about that device. It
`8 probably would have been around the -- you know,
`9 again, I don't remember, so -- we just didn't
`10 spend hardly any time on that device because we
`11 just didn't think that was a viable, you know,
`12 commercial device.
`13 Q. And what do you mean by it wasn't a viable
`14 commercial device?
`15 A. I should say, that was my belief. But in
`16 that -- we knew the physicians would prefer to
`17 have a rapid exchange device versus a
`18 over-the-wire device because it becomes more
`19 cumbersome and difficult to use an over-the-wire
`20 device. They have to pull out a long guidewire.
`21 It just makes the procedure more difficult.
`22 Q. And I believe in your declaration you mention
`23 that the over-the-wire version would have been
`24 faster to market than the rapid exchange version;
`25 is that correct?
`
`1 it.
`2 BY MS. TREMBLAY:
`3 Q. So you were saying that you don't recall
`4 personally working on the over-the-wire version;
`5 is that correct?
`6 A. Well, again, personally I didn't really --
`7 other than be involved with direction and seeing
`8 some of the testing perhaps, I wasn't involved
`9 directly with either of these, other than
`10 oversight and direction, so --
`11 Q. Okay. So who was the primary