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`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _____________________________________
` MYLAN PHARMACEUTICALS INC.,
` Petitioner,
` v.
` SANOFI-AVENTIS DEUTSCHLAND GMBH,
` Patent Owner.
` _____________________________________
` Case IPR2018-01670
` Case IPR2018-01675
` Case IPR2018-01676
` Case IPR2018-01678
` Case IPR2018-01679
` Case IPR2018-01680
` Case IPR2018-01682
` Case IPR2018-01684
` Case IPR2019-00122
` Patent No. 8,603,044
` Patent No. 8,679,069
` Patent No. 8,992,486
` Patent No. 9,526,844
` Patent No. 9,604,008
` ____________________________
`
` DEPOSITION of ALEXANDER H. SLOCUM, Ph.D.
` Manchester, New Hampshire
` Tuesday, August 27, 2019
`
`Reported by:
`Dana Welch, LSR, CSR, RPR, CRR, CRC
`Job #166531
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` August 27, 2019
` 9:00 a.m.
`
` Deposition of Alexander Slocum, Ph.D.,
`held at Hilton Garden Inn, 101 South Commercial
`Street, Manchester, New Hampshire 03101, before
`Dana Welch, Licensed Shorthand Reporter (NH#118),
`Registered Professional Reporter, Certified
`Realtime Reporter and Notary Public of the State of
`New Hampshire.
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`APPEARANCES:
`For the Patent Owner:
`WEIL, GOTSHAL & MANGES
`BY: SUTTON ANSLEY, ESQ.
`2001 M Street, NW
`Washington, DC 20036
`
`For the Patent Owner:
`FISH & RICHARDSON
`BY: MATTHEW COLVIN, ESQ.
`1717 Main Street
`Dallas, TX 75201
`
`and
`FISH & RICHARDSON
`JOHN GOETZ, ESQ.
`601 Lexington Avenue
`New York, NY 10022
`
`--- appearances continue ---
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`For the Petitioner:
`WILSON SONSINI GOODRICH & ROSATI
`BY: WESLEY DERRYBERRY, ESQ.
`1700 K Street NW
`Washington, DC 20006
`
`-- and --
`WILSON SONSINI GOODRICH & ROSATI
`BY: DOUGLAS CARSTEN, ESQ.
`12235 El Camino Real
`San Diego, CA 92130
`
`For Pfizer:
`WINSTON & STRAWN
`BY: DAN HOANG, ESQ.
`35 W. Wacker Drive
`Chicago, IL 60601
`
`Also Present: Karl Leinsing, MSME
` Matthew Greinert (Mylan)
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` SLOCUM
` P R O C E E D I N G S
` ALEXANDER SLOCUM, Ph.D.,
` having been first duly sworn on oath,
`was examined and testified as follows:
` EXAMINATION
` BY MR. CARSTEN:
` Q. Good morning, Dr. Slocum.
` A. Good morning.
` Q. What is your home address?
` A. One Merrill Crossing, Bow, New Hampshire.
` Q. And where do you work today?
` A. Today?
` Q. Well, I mean, where is your current
` employment?
` A. I'm sorry. Yeah. My regular employer is
` the Massachusetts Institute of Technology.
` Q. And you're still employed by MIT?
` A. I am.
` Q. In what capacity?
` A. I am a Walter and Hazel May Professor of
` Mechanical Engineering.
` Q. When were you retained by counsel for
` services in connection with the IPR?
` A. Well, in October, it was in the fall time
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` SLOCUM
` of 2017 is when I was engaged by Weil to assist
` with the Sanofi patents. I don't recall -- nothing
` really happened until this May. So I don't recall
` the original letter that said IPR or whatever.
` Q. So you're aware that's a District Court
` action in which Sanofi has asserted Mylan infringes
` certain of its patents, correct?
` A. I'm aware of the District Court
` proceedings.
` Q. And then you're also aware of separate IPR
` proceedings involving Mylan's challenge to the
` validity for the ones at issue here of various
` device patents, correct?
` A. I understand that. And that's what I have
` this report on, I came here to be deposed on.
` Q. Good. Well, I'm here to depose you, so I
` think we've got a perfect fit.
` You mentioned fall of 2017, do you recall
` whether that communication with the lawyers from
` Weil had to do with the District Court or the IPR?
` A. I don't recall.
` Q. Who called you from Weil?
` A. Back then it was Anish Desai, and I don't
` know how to spell his name.
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` SLOCUM
` Q. That's fine. At some point you were
` provided a document to fill out that -- a
` confidentiality order or a protective order? Do
` you remember this?
` A. It might have been back then, but I don't
` recall.
` Q. Okay. Do you recall reading a protective
` order about how to handle confidential information
` that you may receive in connection with your work
` in the case?
` A. You know, I don't recall. Usually there's
` some document. That was what, two years ago? But
` I treat everything on these cases confidential.
` Q. And do you recall actually signing and
` returning to Weil this document in connection with
` a protective order saying you agreed to be bound by
` the terms?
` A. Again, I don't recall if there was a
` protective order, like a court protective order.
` But I did sign, you know, the letter that said I
` agree that I'm going to work with you.
` Q. Okay. Do you, in your mind, recall the
` first time that you learned that there was an IPR
` involving the Sanofi patents?
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` SLOCUM
` A. I don't recall the date. Like I said, in
` May of this year is when I started working on my
` report. I don't recall an earlier date.
` Q. Okay. So to the best of your knowledge,
` the first time that you recall working on your
` declaration, and you've got a copy of it in front
` of you, it's Sanofi Exhibit 2107.
` The first time you recall working on that
` declaration document was starting in May -- I'm
` sorry -- did you say May -- May 2019; is that
` right?
` A. Yes, this year.
` Q. May 2019, great.
` Between the fall of 2017 when you first
` started and May of 2019 when you first started
` working on the declaration at issue today, did you
` see any Mylan confidential information?
` A. No. Everything between when I first said
` I'd be happy to help Weil, you know, with whatever
` they need from me and May, I think it was mostly
` what's the schedule, when do you guys want me. And
` nothing happened in terms of me digging into
` anything until I started on this report, yeah.
` Q. So apart from scheduling and so forth, you
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` SLOCUM
` didn't -- is it true that you didn't review any
` documents in connection with this case between the
` fall of 2017 and May of 2019?
` MR. ANSLEY: I'd caution the witness not
` to reveal any communications with the attorneys.
` You can answer.
` A. I'm trying to think. I think I might have
` reviewed a patent, one of the Sanofi patents or
` something, but there was no substantive anything
` that happened until this May.
` Q. Do you recall receiving any documents that
` were labeled confidential in connection with your
` work in the case between fall of 2017 and May of
` 2019?
` A. I do not think I did, not that I can
` recall.
` Q. Would you have records of when and what
` you received from counsel at Weil between fall of
` 2017 and May of 2019?
` A. Well, if I received anything, they would
` have sent it to me. And I don't have anything -- I
` don't have anything. So I don't keep a formal
` logbook. I just -- if anything I get, it's in my
` file, and there's nothing in there. Everything --
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` SLOCUM
` like I said, I started really working on this case
` in association with this response to the IPR
` opinions and Mr. Leinsing.
` Q. Is it correct that the first thing you
` remember seeing in the case that you started
` working on was Karl Leinsing's declaration?
` A. Well, with respect -- I think that's a
` fair statement. Like I said, I might have read or
` looked through one of the Sanofi patents earlier to
` familiarize myself with what this whole thing is
` about in terms of the field. But anything that --
` in answer to your question, yeah, that would
` probably be it, Mr. Leinsing's opinions.
` Q. Okay. So about how long did you spend in
` preparation of Sanofi Exhibit 2107?
` A. So I worked on it in May and June, and the
` total -- I refresh myself -- was about 190 hours
` total.
` Q. Okay. So between May and June, 40-hour
` work week assuming -- that's about five weeks; is
` that about right, full time work?
` A. Well, I don't work in typical classical
` 40-hour weeks. I do things in chunks.
` Q. Okay.
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` SLOCUM
` A. But the total time was about that. There
` were some marathon sessions.
` Q. Okay. I see. So while it wasn't
` interspersed in 40-hour chunks, let's say, over the
` course of a week, it was about 190 hours total, and
` you may have had a few marathon sessions in there
` of greater than eight hours?
` A. Correct.
` Q. Okay. Did you write this opinion
` yourself?
` A. All of the opinions in here are mine.
` There's some back and forth.
` Q. That's not my question. Did you write
` this document yourself?
` A. I don't know how to answer that because I
` wrote big chunks. There are certain parts that are
` boilerplate in terms of like the law says. But all
` the technical opinions and stuff I did write.
` Q. Okay.
` A. And then there's, you know, editing
` obviously that happens.
` Q. I see.
` So the legal stuff, if you'll have it, the
` lawyers provided to you that boilerplate, but
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` SLOCUM
` anything technical is yours; is that fair?
` A. Right. The technical writing and opinions
` are mine.
` Q. All right. You said you reviewed a Sanofi
` patent just to see what the field was, et cetera.
` Do you recall that?
` A. Yes.
` Q. Until the fall of 2017 when you were
` approached by Weil, what was the state of your
` experience with respect to injector pens?
` A. My mother had type 2 diabetes, and I used
` to inject her and myself in sympathy, obviously not
` squirting the juice in. But that was -- and if I
` get a little emotional, sorry, it was tough.
` Q. Well, I understand.
` A. So I did this for several years and, yeah,
` she died.
` Q. I'm terribly sorry for your loss.
` Diabetes is a terrible thing.
` A. Tough.
` Q. Apart from that very real personal
` experience, in your professional capacity, what was
` the state of your experience with respect to
` injector pens as of the fall of 2017?
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` SLOCUM
` A. Well, I had not done, myself, personally,
` any design work or, you know, for example in the
` course of my scientific duties, investigative
` studies of them. I just had the personal
` experience with my mother.
` Q. Right. Are you -- I don't mean to be too
` personal, but you said you sympathetically injected
` yourself as well. Are you diabetic, sir?
` A. I'm not, but to feel the pain of the
` needle with her.
` Q. You wanted to know what it was that she
` was experiencing, and so you did it yourself, to
` yourself, just didn't inject the liquid; is that
` what you're saying?
` A. Well, she resisted doing treatment, so I
` said -- I don't recall exact, Mom, look, it's not
` that bad, so you pinch and stick, there. She's
` pretty tough -- she was pretty tough, so she said,
` oh, okay.
` Q. What was the timing in which -- what was
` the timing in which you were helping your mom with
` her diabetes and doing the injections?
` A. It started about ten years ago.
` Q. So somewhere in the 2009 time frame?
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` SLOCUM
` A. Yes.
` Q. And how long were you helping your mom
` with her injections?
` A. Couple of years.
` Q. Do you recall what devices you were using?
` A. It was gray, that's all I remember.
` Q. Just remember a lot of gray?
` A. It was gray.
` Q. Got it. Okay. Fair enough.
` So just to make it clear, apart from your
` personal experience with injector pens, as of fall
` 2017, you had no direct experience in a
` professional capacity with injector pens, right?
` A. Well, these are the insulin injector pens.
` I've done syringe work, but not insulin injector
` pens.
` Q. Okay. Let's talk a little bit then about
` your work with syringes. Were these injector pens
` for things other than diabetes that you had worked
` on in a professional capacity?
` A. I wouldn't call them injector pens.
` Q. What would you call -- I'm trying to
` understand what the syringes were. Would you
` describe that for me, please?
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` SLOCUM
` A. So for example, injecting collagen,
` thrombin, herbs, and spices into knee joints for
` ligament tear work.
` Q. Okay.
` A. And then work on a lyophilization pen.
` Q. Lyophilization pen.
` How does that -- very briefly, I don't
` have a good sense in my head of what that means.
` Could you please describe what that is?
` A. Okay. So drugs often that are injected
` are liquid, and you have to keep them refrigerated,
` and there's a lot of stringent things. If you can
` freeze dry the drug so it's a powder, it is now
` very transportable. So you have to reconstitute it
` with water, but that has to be done in a very
` specific way. So normally that is done by a health
` care professional. So we had a project to make it
` so a user, you know, a patient, could reconstitute
` the drug themselves and then inject it.
` Q. I see. And when you say a lyophilized
` syringe, was the drug product in the syringe
` already to which you'd add the liquid, and then
` shake it up and get it ready to go or was it in a
` separate vial?
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` SLOCUM
` A. And let me correct. I said lyophilization
` pen earlier. I'm sorry. I think I was swapping.
` We were talking about the insulin pen and syringes.
` I don't think it's referred to as a lyophilization
` pen. It's a lyophilization syringe and it's --
` Q. Uh-huh.
` A. And the mode normally is they're separate.
` I think the industry is looking to, in the future,
` make them a modular -- and this is not confidential
` with anybody that I'm aware of. Kind of like when
` you buy yogurt, and there's the yogurt and then it
` comes with the crunchy bits on top separate, and
` you then combine them.
` Q. Okay. Now, the lyophilization syringe
` that you were working on, that had a separate
` component or separate vial or what have you that
` you would reconstitute the lyophilized powder and
` thereafter draw it up into a syringe; is that
` correct?
` A. That's an oversimplification of how the
` system works, but it's a reasonable one.
` Q. Okay. All right. As of -- have we now
` exhausted the professional experience that you had
` had with syringes as of fall 2017, or were there
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` SLOCUM
` others?
` A. There were also classes of biopsy tools
` that you have a special needle where we designed
` the needles. And you put the needle in, and I
` don't think you want a tutorial on needle tip
` design for biopsy, and then you pull back on the
` plunger to pull in the tissue sample.
` Q. So that actually takes in sample as
` opposed to releases or injects material, but it is
` a needle, correct?
` A. Correct. And then there's other ones if
` you want me to.
` Q. Well, is it -- I would like to know what
` the level of your professional experience was with
` respect to syringes generally as of fall of 2017.
` And so we talked, I think, about the lyophilization
` syringes, we talked about the knee joint syringes,
` and now we've just talked about the biopsy needles.
` Anything else?
` A. Correct. And then for doing epidurals in
` the spine, it's very, again, I don't think you want
` a medical treatise on this. But it's very -- you
` have to be very careful when you go through the
` tissues, which are much more difficult to penetrate
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` SLOCUM
` and understand -- for the doctor to understand
` where the needle tip is than just giving a simple
` injection in a soft tissue layer. And so this was
` a tissue sensing syringe, tissue sensing needle
` that's on the syringe for doing epidurals. And we
` did quite a lot of work on those devices.
` Q. And what was the time frame on the work on
` the epidural needles?
` A. I think that was also about a decade ago.
` It spanned several years.
` Q. 2009ish?
` A. I can check in my résumé because we have
` the publications and whatnot if you want.
` Q. Sure. If that would help you then, it
` would be good to --
` A. If you need a more accurate date than
` about that, then we should check.
` Q. I'll give you a copy of your CV.
` A. I have it here.
` Q. You have it in there already? We've got
` it separate as well, 2108, just hand it to you.
` A. So for example, just from the other one,
` if you look at 56 on page 16, that talks about the
` biopsy needles.
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` Q. 56 on page 16. Do you know what the year
` of that was? I don't see years here, at least for
` that entry. Maybe I'm missing it.
` A. They're in chronological order. So you're
` right, that is missing, but it would be 2006 or
` '7 --
` Q. Okay.
` A. -- that one.
` Q. And that was the biopsy needle we just
` talked about, right?
` A. Correct.
` Where was that other one? Okay. If you
` go to 72, you see there it's Bassett, Slocum,
` Masiakos, Pryor, Farokhzad, and Karp; "The Design
` of a Mechanical Clutch-based Needle Insertion
` Device."
` Q. Which project is that, Doctor?
` A. That is the epidural needle device.
` Q. And this reflects a date of -- I don't
` think it has a date there, but the one after it is
` from 2010?
` A. Right. If you were to click on this DOI
` that's -- if you have the digital version of the
` résumé and you click on that link, it will take you
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` there.
` Q. Pops it right up, I see.
` A. But, again, it's about 2009 or '10.
` Q. Okay. And then the knee joint work, do
` you recall when that was?
` A. That would have been even earlier. That
` was with Dr. Murray. I got to find where that is.
` That was a big project with my design class. And I
` don't recall where and when we published that or if
` she just published it on terms of the medical
` results, which then I would have just been an
` acknowledgment.
` Q. Okay. Do you recall roughly when that
` was?
` A. That was probably a dozen years or so ago.
` Q. So probably 2005, 2006 era to 2007?
` A. Yeah, somewhere around there is about
` fair.
` Q. Okay.
` A. It might be in the -- I don't know how
` much you want -- time you want me to spend
` searching through the -- for example, the
` conference papers where it might be. If you had
` the digital version of this, it would be a lot
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` easier.
` Q. If we had digital versions of a lot of
` things, things would be a lot easier I suspect.
` My last question on this realm is the
` lyophilization syringe you talked about. Can you
` put a date on that for me?
` A. That was just in the last couple of years.
` Q. Okay.
` A. And then there was one other bunch of
` needle work we did, which was for breast biopsies.
` Q. And this is different than the biopsy
` needle that we just talked about project?
` A. It is.
` Q. Okay. And what was the year of that and
` if you find an exemplary publication in your CV?
` A. Right. And I have that. Hold on. Okay.
` If you go to number 66, for example, on page 16, a
` patient mounted telerobotic tool for CT guided
` percutaneous interventions. So we do biopsies for
` the breast, and then sometimes they want to also
` inject tracers.
` Q. I see. Okay.
` And that is a 2008 publication?
` A. Correct.
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` Q. Was there any other professional
` experience that you can recall having with respect
` to syringes or needles other than the five or six
` things we talked about?
` A. If you go to page 17, number 83, "Design
` of a Surgical Port for a Minimally Invasive
` Beating-Intracardial Procedures."
` This is so you can access a beating heart
` without having to do open chest surgery to go
` inside to fix things, particularly in small
` children, like holes, or for adults, valve
` replacement where you cannot do it percutaneously.
` Q. And that's from 2011?
` A. That was 2011, we started.
` Q. Okay. Any other pen, syringe, needle
` experience?
` A. I think that's all I can recall. I teach
` a medical design class, and there's quite often
` projects that involve syringes and needles, but
` these are the ones that I recall that we took
` forward quite a bit to where they're published.
` Q. When you say the word "syringe," and
` you've said it a few times, I think, what's the
` mechanism that drives the plunger rod in a syringe?
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` A. Well, it's either going to be your thumb
` or, for example, one of the -- on the knee, we
` called it the knee gooper because it injected goop
` into the knee, and that was an electric motor.
` Q. So either driving your thumb through a rod
` attached to the plunger straight in or through some
` kind of electric motor which advances the plunger;
` those are the two things I think you just said; is
` that right?
` A. Well, in the work I did, it was either I
` guess you'd call it a classic syringe of thumb on
` the end of a plunger or the electric motor driven
` plunger.
` Q. Okay. So would you agree with me -- you
` mentioned in your declaration Newton's laws several
` times. You'd agree with me that as of the priority
` date here, Newton's laws were obvious to a person
` of ordinary skill in the art?
` A. Newton's laws are known. I wouldn't say
` it's obvious. They're known. This is in the ether
` that constitutes a mechanical engineer, it's in the
` wiring.
` Q. It's sort of fundamental to them. They
` apply Newton's laws routinely on a day-to-day
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` basis; is that fair?
` A. Yes, they should be.
` Q. One would hope?
` A. Yes.
` Q. Okay. There was a section in your expert
` report -- or sorry, your declaration that maybe I
` just misunderstand it or maybe there's an error
` here. I don't know for sure. But let me direct
` you to it and we can clear it up.
` It's at page 12.
` A. Okay.
` Q. It's in paragraph 31. It's about three
` lines down. It says, "Most people also know that
` the distance the wedge moves in is less than the
` distance it makes the object move up."
` A. That's wrong.
` Q. I think that's wrong, isn't it?
` A. Yeah, no. You move the wedge in more than
` it goes up.
` Q. I'm going to hand you a pen. Can you
` correct that for me, please?
` A. Yeah. I'm sorry. That is a -- it is
` more.
` Q. And would you initial it for me after
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` you're done making whatever correction is
` satisfactory to you?
` A. (Complying).
` Q. And then would you also turn --
` A. Wait a second.
` Q. Sure.
` A. Yeah. That would have come from -- you
` think of the force you push in with is less than
` the force you get up.
` Q. Right. The way this is written, there's
` no mechanical advantage, it's actually a mechanical
` disadvantage.
` A. Yes. I apologize for my dyslexia on that.
` Q. I'm not asking you to apologize. I just
` want to make sure I understood it. And when I read
` this, I said here's a professor from MIT, and this
` is not what I understand. So thank you for
` correcting that.
` On the cover page, though, would you
` please write "Annotated by" and then your name?
` A. Uh-huh.
` Q. So that way we know that's the one you've
` got your markups in.
` A. (Complying).
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` Q. And if you date that for me as well, today
` is the 27th.
` A. Okay.
` Q. Thank you so much. And then maybe we can
` make some arrangements to have this copied and
` circulated. At least the pages that were
` annotated, et cetera.
` MR. ANSLEY: Do you want to mark it as a
` separate exhibit?
` MR. CARSTEN: I think it's a good idea, if
` you don't mind. I'd ask the court reporter to mark
` as -- call it Slocum 1 for the time being, and then
` I'm sure there are going to be particular IPR
` requirements, but...
` MR. ANSLEY: That's fine with me, if
` that's fine with you, Matt.
` MR. COLVIN: That's fine.
` MR. DERRYBERRY: I can get the next
` exhibit for ours here.
` MR. CARSTEN: Why don't you do that. Bear
` with me. We're just waiting on a number, and then
` we'll get that labeled.
` MR. DERRYBERRY: Looks like the highest
` exhibit that we have is 1042, but just to be
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` safe -- 1050.
` MR. CARSTEN: 1050. Can we mark this as
` Exhibit 1050, please. Any objection?
` MR. ANSLEY: No.
` (Exhibit 1050, Declaration of Alexander
` Slocum, Ph.D. in Support of Patent Owner
` Responses, Sanofi Exhibit 2107.001 - 406 and
` 2108.001 - 042, marked for identification.)
` BY MR. CARSTEN:
` Q. Thank you, Dr. Slocum.
` Do you know Dr. Charles Reinholtz?
` A. I may have heard the name, but I don't
` have a face or any recollection.
` Q. Do you ever talk to Dr. Reinholtz that you
` know of?
` A. Gee, if I did, I don't remember. I'm
` sorry.
` Q. You've got your declaration in front of
` you. Feel free to -- oh, I'm sorry. Were you
` thinking still?
` A. I'm just trying to recall, I mean, there's
` just so many names associated with this stuff,
` it's -- I don't recall.
` Q. I'm not trying to hide the ball on you.
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` Dr. Reinholtz is another one of Sanofi's experts in
` the case, and I wondered whether you'd ever talked
` to him about the case or talked to him about
` anything, or separately if you knew who he was.
` A. Like I said, there's so many names and I
` think I've heard the name, but I just don't recall.
` I've been focused on my report here.
` Q. Understood.
` Okay. Your declaration is in front of
` you, feel free to refer to it as much or as little
` as you'd like.
` In here, though, you talk about the
` history, at least some history of injector pens.
` Where did your knowledge, your historical knowledge
` of injector pens and when they were introduced to
` market come from?
` A. So as part of my work on this, I spoke
` with Mr. Rob Veasey. And I would say that one of
` the reasons I wanted to talk with him was, first of
` all, he's the inventor on these things, the Sanofi
` patents, or an inventor.
` But I didn't have personal knowledge of
` the industry at the time of the invention, so I
` wanted to talk to someone who was clearly in the
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` thick of it at the time.
` Q. So when did you speak to -- I think his
` first name is Rob; is that right?
` A. I think it's Rob.
` Q. I don't know if he's a doctor or a Mister
` I'm just going to call him Rob Veasey, if that's
` okay.
` A. That's fine.
` Q. When did you in connection with your work
` in the case talk to Rob Veasey?
` A. I think it was in May. May or June, but
` one of those two. This year.
` Q. Sure. Do you recall if it was early in
` your work to give you context for what you were
` looking at, or do you recall if it was late in
` trying to backfill things as you're trying to
` finalize your declaration?
` A. I don't recall exactly. But I think it
` was in May.
` Q. Okay. And do you recall what you talked
` about with Rob Veasey?
` A. The background. And let me think here,
` hold on. Yeah, the background, and then there's
` a -- he told me that he also knew that the FlexPen
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