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`P R O C E E D I N G S
`THE VIDEOGRAPHER: Okay. We are on the
`video record at 9:03 a.m.
`THE REPORTER: We are on the record.
` (Witness sworn.)
`HOWARD C. ROOT,
`Called as a witness, being first
`duly sworn, was examined and
`testified as follows:
`EXAMINATION
`
`BY MR. MORTON:
`Q.
`Good morning, Mr. Root.
`A.
`Good morning.
`MR. MORTON: Just so we don't have to go
`over -- over old ground, just want to confirm our
`agreement on the record that we can use the prior
`deposition transcripts from the other IPRs in these
`IPRs.
`
`MS. NORGARD: Confirmed.
`MR. MORTON: All right.
`BY MR. MORTON:
`Q.
`I want to make sure you have your
`declaration, Mr. Root, so I'll hand you what's been
`marked Teleflex Exhibit 2118, so you can refer to that
`throughout the day if you need to.
`STIREWALT & ASSOCIATES
`1-800-553-1953 info@stirewalt.com
`
`4
`If we go to paragraph 5 of your declaration
`to start. This is where you're talking about your --
`when you came up with the idea for the GuideLiner back
`in 2004. You see that?
`A.
`Yes.
`Q.
`You say that you, "By that time I had
`recognized issues physicians were experiencing with
`guide catheter backout in complex interventional
`coronary procedures." You see that?
`A.
`Yes.
`Q.
`I guess, first of all, can you explain to me
`what "complex interventional coronary procedures" are?
`A.
`Well in general terms it's the opposite of
`simple. A complex case may be where there's a tight
`lesion or there is a chronic total occlusion, or there
`is just an anatomy where it's difficult to get your
`guide in the correct position, so it makes the case
`more difficult for the cardiologist to perform.
`Q.
`So I think you gave me three things; a tight
`lesion, chronic occlusion, and complex or difficult
`anatomy. Are those basically the three things you can
`think of that would result in a procedure being a
`complex procedure?
`A.
`I mean there might be other things as well,
`but as it -- you know, those are the three that I --
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`1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`MEDTRONIC, INC., AND, MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner.
`________________
`Case No. IPR2020-01341
`Case No. IPR2020-01342
`Case No. IPR2020-01343
`Case No. IPR2020-01344
`U.S. Patent No. 8,142,413
`________________
`
`DEPOSITION OF HOWARD C. ROOT
`
`VOLUME I, PAGES 1 - 107
`JULY 15, 2021
`
` (The following is the deposition of HOWARD
`C. ROOT, taken pursuant to Notice of Taking
`Deposition, via videotape, at Carlson Caspers
`Vandenburgh & Lindquist, P.A., 4200 Capella Tower,
`225 South Sixth Street, in the City of Minneapolis,
`State of Minnesota, commencing at approximately 9:03
`o'clock a.m., July 15, 2021.)
`
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`APPEARANCES:
` On Behalf of the Petitioner:
` Cyrus A. Morton
` Deanna Thompson
` ROBINS KAPLAN, LLP
` 2800 LaSalle Plaza
` 800 LaSalle Avenue
` Minneapolis, Minnesota 55402
`
` On Behalf of the Patent Owner:
`
` Tara C. Norgard
` Alex S. Rinn
` CARLSON CASPERS VANDENBURGH
` & LINDQUIST, P.A.
` 4200 Capella Tower
` 225 South Sixth Street
` Minneapolis, Minnesota 55402
`
`ALSO PRESENT:
`
` Dan Burton, Videographer
` Greg Smock, Teleflex
`
`EXAMINATION INDEX
`WITNESS EXAMINED BY PAGE
`Mr. Root
`Mr. Morton
` 3
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`5
`that I would say definitely make that more of a
`complex.
`Q.
`Okay. And so the -- the purpose of your
`invention then was to address the -- the backout
`problem in those types of procedures?
`A.
`The purpose was to get better back-up
`support, and there's a variety of procedures where
`that's useful. These are three types of procedures
`where it would be useful. There's also utility in
`getting deeper guide placement and better back-up
`support to inject contrast or medication into a
`sub-selected artery.
`Q.
`Okay. I think you gave me two more, then?
`What were those two you're referring to that were I
`guess maybe additional reasons why you'd want
`increased back-up support?
`A.
`Well another reason why you want a rapid
`exchange guide extension is to be able to place the
`tip of the guide into a selected branch of the
`coronary anatomy so you can inject contrast or
`medications into that artery without getting it into
`another artery.
`Q.
`Okay. And I'm sorry to belabor the point,
`but I feel like there's four things then that you've
`said might be a purpose for needing increased back-up
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`support; the more difficult anatomy, chronic or total
`occlusion, a tight lesion, and getting deeper into a
`specific coronary artery to inject contrast; is that
`right?
`A.
`I would say those are four benefits of doing
`guide extension. I don't -- I don't think I'd call it
`a purpose of guide extension, but I think it's
`definitely a benefit of doing rapid exchange guide
`extension.
`Q.
`Okay. And the purpose of it is to provide
`increased back-up support for those various
`applications; is that right?
`A.
`Increased back-up support and deeper
`intubation, which are -- they kind of go hand in hand.
`Q.
`Okay. And what's "deeper intubation," for
`the record?
`A.
`Being able to place the guide catheter
`deeper into the coronary anatomy so that you can
`sub-select one branch versus having to deliver the
`medication into all the branches of that coronary
`anatomy.
`Q.
`Okay. Is that different than what you were
`saying about in terms of injecting contrast?
`A.
`No, that is what I was talking about.
`Q.
`Okay. Just showing you what's been marked
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`7
`
`Teleflex Exhibit 2253. This is the notebook of your
`coinventor, Mr. Sutton. Do you see that?
`A.
`Yes.
`Q.
`And when he talks about the GuideLiner, this
`is on page 7 of the exhibit, he gives the idea. He
`says, the "idea relates to interventional coronary
`procedures and specifically to accessing and crossing
`tough or chronic total occlusions." You see that?
`A.
`I see that.
`Q.
`And I -- I assume that's consistent with
`what you said in your declaration when you're talking
`about the purpose relates to complex interventional
`coronary procedures?
`A.
`That's part of what I was talking about when
`he mentions "chronic total occlusions."
`Q.
`Okay. And as you look back at this
`statement of the idea from Mr. Sutton, do you think
`the a -- the additional benefits or whatever that you
`just gave to me here today were in your mind at this
`time back in early 2005, or are those benefits that
`were discovered later?
`MS. NORGARD: Objection to the form of the
`
`question.
`A.
`I was thinking about the benefits that we
`talked about today back in 2004/2005 when we had the
`STIREWALT & ASSOCIATES
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`8
`initial concept of this device, in general terms. I
`mean I can't be specific about exact dates and exact
`thoughts, but as I remember it, we were thinking about
`more than just chronic total occlusions when we were
`initially inventing the device.
`Q.
`Okay. And do you know if that's written
`down anywhere, or if that's just your recollection?
`A.
`I don't know. I don't have the documents in
`front of me. If there is something there, you know,
`he talks about chronic total occlusions in sentence
`one, and then Gregg mentions the -- the idea is to
`provide more back-up support, and "back-up support" is
`broader than just "chronic total occlusions," so he's
`-- he's going into more than just a CTO device here,
`but this idea in the notebook isn't a full-fledged
`description of our concept and the purposes.
`Q.
`Okay. But it's still fair to say that the
`concept was at least provide increased back-up support
`for complex interventional coronary procedures, as you
`say in your declaration?
`A.
`Yeah, that was -- that was the purpose of it
`was to provide increased back-up support for -- yeah,
`for those complex procedures.
`Q.
`And you don't need increased back-up support
`if the procedure is not complex; right?
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`A.
`Well it's kind of self-defining. The --
`What makes it complex is that it's hard to get your
`guide in position and the stent across. So you could
`probably have a complex case that doesn't involve
`that, but as we're talking about it today for the
`GuideLiner, that's generally accurate.
`Q.
`Okay. I think you told me, yes, if it's not
`a complex procedure then you don't need additional
`back-up support, you don't need the invention; is that
`right?
`A.
`The only caveat is there are other things
`that can make complex procedures, probably not
`relevant to the GuideLiner. So I'm not saying that
`every complex procedure requires a GuideLiner, but
`where physicians use the GuideLiner, it's generally --
`you know, generally a complex procedure. I mean more
`than generally, it's -- it's the vast majority of the
`times it would be a complex procedure. But there may
`be other times they use it, and there may be other
`complex procedures where they would not use a
`GuideLiner.
`Q.
`Okay. And so back at this time in 2005,
`there were certainly plenty of procedures being done
`with just a standard guide catheter and no guide
`extension; right?
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`A.
`Q.
`
`Yes.
`And is --
`And I take it is that still common today,
`there's still procedures that are being done with just
`a standard guide catheter and no GuideLiner?
`A.
`Well I've been out of the interventional
`cardiology business for the last four years now, so if
`I go back to when I was last in it, it was -- there
`was still complex procedures being done without the
`GuideLiner.
`Q.
`Okay. And so do you -- do you know, in
`general, what are the indications for using a
`GuideLiner today, or when you wouldn't use it?
`A.
`Well the -- the reasons why a physician
`would use it, I mean the indications are more, you
`know, a regulatory term, so I wouldn't use the
`indications for using it, but the reasons, in more
`general layman's terms, the reasons for using a
`GuideLiner go back to what I talked about earlier,
`which is they want to inject contrast or medication
`into a branch artery, or they have a chronic total
`occlusion where it's hard to get the guidewire across,
`or they have a takeoff of the coronary anatomy that's
`difficult to get the -- the stent or the balloon
`around and the GuideLiner will help straighten that
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`out, or the aorta and the takeoff of the coronary
`artery is such that it's hard to position the guide
`catheter in the ostium without having it just back
`out, and the GuideLiner will solidify that position.
`Q.
`Okay. Is it common to try to just use a
`standard guide catheter first, and then if it doesn't
`work you can try using a GuideLiner?
`A.
`Yes.
`Q.
`So in paragraph 17 of your declaration --
`A.
`Should I put this someplace, or [indicating
`exhibit] --
`Q.
`You can just -- It's already part of the
`record, so it doesn't --
`A.
`Okay.
`Q.
`-- matter too much.
`So in paragraph 17 you start discussing
`prototype testing; you see that?
`A.
`Yes.
`Q.
`And according to your testimony in the
`declaration, your company, VSI, "did not see the need
`to, and we did not, create formal test protocols and
`reports to prove that the initial GuideLiner concept
`worked during its design development phase." Right?
`A.
`I see that.
`Q.
`And so I guess because of that, you do not
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`have any documents recording any of the rapid exchange
`GuideLiner prototype testing; is that right?
`MS. NORGARD: Objection.
`A.
`I'm not sure what all documents they've
`provided to you, but we didn't have many. We had
`notes, and the lab notebooks that we already talked
`about, but we didn't see the need to create formal
`reports and keep formal records.
`Q.
`Sure. And I -- I know you've looked at this
`issue a lot and you've given a lot of declarations, so
`I just want to be clear. You don't point to and can't
`point to any lab notebook entries regarding testing,
`prototype testing of the rapid exchange version of
`GuideLiner; right?
`A.
`Again, I don't know what documents they've
`provided to you, but I don't have any other documents
`of that. I don't have any documents in my possession
`on that.
`Q.
`Okay. Well you have a lengthy declaration.
`Have you pointed to any laboratory notebook entries
`showing testing of the rapid exchange version of
`GuideLiner?
`A.
`I -- I don't think we have. To the extent
`you -- you define what "testing" is. I mean we have
`pictures of the GuideLiner in the two-dimensional
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`model, which shows that testing occurred, but if -- a
`formal test report, no, we don't have one of those.
`Q.
`Okay. You don't have any -- any notes
`written down regarding testing of the rapid exchange
`version of GuideLiner?
`A.
`You know, other than what we have in the
`declaration, I don't have anything else, but again we
`have some pictures of the testing apparatus, and I'm
`not sure exactly what else we have in here, but
`there's nothing else other than in my declaration.
`Q.
`Okay. And can you identify any other
`document, other than the picture of the testing
`apparatus?
`A.
`As it relates to what?
`Q.
`Initial prototype testing of the rapid
`exchange version of GuideLiner.
`A.
`You know, again, as it relates to the
`testing itself, I would say no, I can't point to it.
`In terms of the creation of the prototypes that we
`tested, there are several documents here, prints and
`drawings, but not a test report or indications of the
`results of the tests that we performed.
`Q.
`Just showing you what's been marked Teleflex
`Exhibit 2254. Do you recognize this as a -- a memo
`written by you on -- dated February 4, 2005 regarding
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`GuideLiner?
`A.
`Yes.
`Q.
`And in the "to" line you say that this is to
`the "GuideLiner Design History File." You see that?
`A.
`Yes.
`Q.
`So did you have a GuideLiner design history
`file as of this time, February 4, 2005?
`A.
`I don't believe we did. I believe I drafted
`this that it would eventually go in the GuideLiner
`design history file, but probably thought it would
`change as we got there before we started the formal
`file with the team around the development.
`Q.
`When did you -- Well if --
`Do you have a recollection of actually
`having a design history file and when you would have
`started to have that?
`A.
`We started the design history file once we
`went what we called design freeze, which we had the
`package of information ready for the team beyond just
`the R&D and marketing people to be involved in the
`regulatory testing that's required to get the product
`on the market.
`Q.
`So your initial development phase, you're
`saying, you -- you wouldn't keep a design history file
`until you were moving on to the regulatory aspect?
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`A.
`That's generally correct. You know, yeah, I
`-- We would not have a design history file until we
`started the team that would be doing the formal
`testing of the product for the regulatory submission.
`Q.
`Can you explain why you would write this
`memo to the design history file if you typically don't
`have a design history file until much later?
`A.
`Because I would do the document in the way
`it would be used eventually, as opposed to creating a
`document and then having to create a different type of
`document. So this is a way of getting input from
`other people, maybe Jason Garrity or Gregg Sutton, as
`we're refining all the documents that go together, to
`start the design history file.
`Q.
`Wouldn't you normally keep all the documents
`then, so once you had an official design history file
`you could put those documents in there, such as the
`one we're looking at here?
`A.
`Once we started the design history file, we
`would keep all the documents that would go in there,
`but the drafts of these documents before the design
`history file is started would not be kept. Same thing
`with prints and drawings. We'd have uncontrolled
`revisions in the rev 1 and rev 2, and then the design
`history file would start and we'd switch to rev A, and
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`16
`then those documents from rev A onward would all have
`to be saved, but the rev 1 and 2 would not be.
`Q.
`Okay. So when do you think you started
`having an actual design history file for GuideLiner?
`A.
`It was when we pulled together the team that
`was going to bring the product through the regulatory
`to -- to market.
`Q.
`Okay. Do you know if that was in 2005?
`A.
`I don't know if it was 2005. It might have
`been 2006. It was sometime in that timeframe. It was
`after February of 2005, but probably more like later
`in the fall of 2005, or winter or early 2006 would be
`my -- my estimate.
`Q.
`So you've testified previously that you
`think there used to be other documents, and now you
`don't have those documents any more from this time
`period. Do you recall that?
`A.
`I recall generally testifying to that.
`Q.
`So is it your explanation here today that
`you would have created documents in 2005 related to
`the rapid exchange version of GuideLiner, but would
`have thrown them away prior to the creation of the
`formal design history file?
`A.
`When you say "documents," that means
`anything that you wrote down. So certainly we're --
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`Medtronic v. Teleflex
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`17
`in this part of the process we're at a table writing
`down notes and doing drawings, and actually writing on
`the whiteboard, and at the end of that we don't save
`most of that. Most of that gets thrown away.
`Anything that's useful for our current -- our
`continued innovation, would be saved. So we would not
`save documents of -- of ideas or notes before we had a
`formal team which had control document retention for
`the purpose of testing it for getting it on the
`market.
`Q.
`So if you had documents showing a completed
`prototype of rapid exchange version of GuideLiner,
`photographs of that or anything like that, would you
`have thrown those away?
`A.
`If we had a purpose to keep them, we would
`keep them. That would be giving it to our patent
`lawyer for the patent work, or to show other members
`of the team what we were working on or what the idea
`was. This initial draft of the design history file I
`would then continue to change and then finalize it
`when the team started. But most of the other
`documents would be thrown away. So it would be the
`judgment of the person as to what to keep and what to
`throw away. There was not document control at that
`new modality stage of an invention.
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`18
`Q.
`The same question. If you had documents in
`the spring/summer of 2005 relating to any testing of
`prototypes of the rapid exchange version of
`GuideLiner, would you have thrown those away?
`A.
`I would throw them away if I didn't think
`they were useful going forward, and I would keep them
`if I thought they were useful for some other purpose,
`whether it's patents or other -- education of other
`employees, or other discussion.
`Q.
`And you know from your experience, it says
`so in the lab notebooks, I mean you know it might be
`important for exactly why we're here today, right,
`proving up your invention.
`A.
`Well I know it's important to have records
`of your invention and that's why we work with our
`patent lawyers. But it's also important not to
`strangle the development process by trying to save
`every scrap of paper that you write on.
`Q.
`Did you think, in the spring/summer of 2005,
`it was not important to save documents related to
`testing of the rapid exchange version of GuideLiner?
`A.
`To the extent it was necessary or useful for
`the patent work, I would save it, but I didn't
`remember them saying that it was something they
`needed. So the testing we did we did not document,
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`19
`and to the extent we documented it, I did not think it
`was important to keep those notes.
`Q.
`Okay. So you think, and I know you've
`testified that there was testing of the rapid exchange
`version of GuideLiner and the prototypes, but your
`testimony is that either you wrote nothing down, or if
`you did write it down, you wouldn't have kept it; is
`that right?
`A.
`Substantially right, yes.
`Q.
`And specifically you wouldn't have kept it
`like that year; it wouldn't have made it into the
`design history file that you created for this project
`eventually.
`A.
`It -- It would not have made it into the
`design history file because the design history file
`hadn't been started yet, and if I kept the notes like
`a few notes that I kept, it would just be in my own
`personal file for something that I had either to give
`to the patent lawyer or something that I maintained to
`show to some other employees or for other purposes.
`Q.
`Okay. And have you specifically for your
`work on this case, gone back and tried to look at the
`design history file, or asked for it from the lawyers
`or anything like that?
`A.
`Oh, I think we've gone over that for the
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`20
`
`prior cases, the Boston Scientific case or the
`QXMédical case, and I think I went over it at that
`time.
`Q.
`And I take it, again, you could not find any
`documentation of testing of the rapid exchange
`GuideLiner version in 2005.
`A.
`Everything we found we've produced.
`Q.
`So I take that as a "no," you couldn't find
`anything else.
`A.
`Well I'm not sure how you're characterizing
`the documents we produced. I mean some of them have
`drawings of components, and some of them have pictures
`of the GuideLiner in a model. So if you want to say
`that proves that we did testing, then we have
`documents. But I'm saying -- I'm testifying that
`there are no other documents than what we've already
`produced and what's in my declaration.
`Q.
`All right. You also say, in paragraph 17 of
`your declaration, that what you did -- well you say
`you didn't have formal test protocols or reports, you
`see that in the middle of the paragraph?
`A.
`Yes.
`Q.
`And you say, "Instead, what we did was
`perform confirmatory testing in a bench-top, coronary
`model that simulated the native anatomy and
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`IPR2020-01343
`
`Medtronic Ex-1798
`Medtronic v. Teleflex
`
`Page 5 of 39
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`

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`21
`environment for the deployment of the device..." See
`that?
`
`A.
`Yes.
`Q.
`So my first question is, what is
`"confirmatory testing"?
`A.
`Well confirmatory testing is to confirm what
`you pretty much already know, and from the
`mother-and-child over-the-wire guide extension product
`that was already on the market, we knew that if we
`were able to get the guide catheter deeper into the
`coronary anatomy, we would increase the back-up
`support and be able to deliver our devices into more
`distal locations.
`So what we're doing here is confirming that
`our rapid exchange invention is going to perform that
`same way, that we are able to get the guide extension
`deeper into the coronary anatomy, that the guide will
`then be locked in place and will have good position to
`deliver the interventional devices.
`Q.
`Okay. Now in your declaration here you
`don't say precisely when you performed any
`confirmatory test; is that right?
`A.
`Well in this paragraph all we have for a
`date is the July 2005 picture in the PowerPoint
`presentation.
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`Q.
`Okay. And so you can't pinpoint for me when
`any particular confirmatory test occurred; is that
`right?
`A.
`I can give you a pretty good range of when
`it occurred, but I can't give you an exact date.
`Q.
`Okay. And you also don't say who would have
`performed a confirmatory test; is that right?
`A.
`I don't think I have names in this -- in
`this paragraph. I don't.
`Q.
`Okay. And sitting here today, you can't say
`for sure who performed some confirmatory test.
`A.
`Well I -- I know that I did some of that
`testing, along with Gregg Sutton and Jason Garrity and
`Jeff Welch, and there were other people, but I can't
`tell you exactly who.
`Q.
`Okay. So for you or Mr. Garrity or Mr.
`Sutton or Mr. Welch, can you identify any specific
`testing that you know was -- was done?
`A.
`Yes.
`Q.
`Okay. And can you do that by reference to a
`specific date and/or prototype?
`A.
`Well I can't do it to a date. I can give
`you a range of when it occurred, but I can't give you
`a specific day that it happened. And the prototype --
`the picture here in 17 is one of the prototypes we
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`23
`used. We also had a more three-dimensional model that
`we used in order to simulate the coronary anatomy.
`Q.
`Okay. So --
`All right. The picture you've got there,
`you've mentioned this several times, but we all know
`that's not the rapid exchange version of GuideLiner;
`right?
`A.
`
`I -- I --
`Yeah, I think this is the over-the-wire
`version in this picture.
`Q.
`Right. So there is some 2 -- 2D coronary
`model with over-the-wire GuideLiner depicted; right?
`A.
`That's the picture, correct.
`Q.
`Okay. And so I'm asking you about rapid
`exchange version of GuideLiner, and asking if you can
`identify any particular specific testing by a specific
`person of a specific prototype.
`A.
`Well this picture is one of the specific
`tests that we did with the rapid exchange version,
`because you do the same testing with the over the wire
`as you do with the rapid exchange. And this model is
`the two-dimensional model that we used, and then we
`had the three-dimensional model that we used at the
`same time, but I can't give y