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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
` ____________________________
` VOLUME II
` DEPOSITION of ALEXANDER H. SLOCUM, Ph.D.
` Manchester, New Hampshire
` Wednesday, August 28, 2019
`
`Reported by:
`Dana Welch, LSR, CSR, RPR, CRR, CRC
`Job #166533
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` August 28, 2019
` 9:42 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 previously sworn on oath,
` continued to testify as follows:
` EXAMINATION
` BY MR. CARSTEN:
` Q. Good morning, Dr. Slocum.
` A. Good morning.
` Q. You understand that you're still under
` oath from yesterday?
` A. I do.
` Q. Where we left off yesterday, we were
` talking about some of the opinions at the tail end
` of your declaration.
` Before we jump back into that, there's one
` favor I'd like to ask of you, and that is, could
` you grab Exhibit 1052, it's the blowups from 2157,
` the three-pager.
` A. Got it.
` Q. Great.
` The final page of that document is the one
` that you were making some notations on yesterday.
` A. Okay.
` Q. At the top of the page, I'd like you to
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` SLOCUM
` draw for me, if you would, in whatever color you'd
` like, two arrows; one in the axial direction, label
` it, and then one in the radial direction, and label
` that one, if you could.
` Does that make sense?
` A. It does.
` Q. And would you do that for me, please?
` A. Okay.
` (Complying). And I'll initial them.
` Q. Thank you.
` And it's your opinion that a person of
` ordinary skill in the art would have understood the
` axial and radial directions along the lines of the
` arrows that you've drawn on 1052?
` A. In the context of this mechanism.
` Q. Yes, in the context of this mechanism?
` A. Correct.
` Q. Thank you. Okay.
` So let's turn back to finishing off our
` discussion of some of the opinions in that last
` paragraph of your declaration.
` A. It was 650, I think.
` Q. It was paragraph 650, right.
` Just let me know when you've got there.
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` SLOCUM
` A. I'm here.
` Q. So where we left off was about 10 to 12
` lines down. The next sentence that we didn't talk
` about was, "The challenged claims further enabled
` an injection device with a shorter dial extension,
` providing additional benefits for patients lacking
` dexterity."
` With respect to that sentence, the claims
` don't require any particular level of dial
` extension, short or long, do they?
` A. Again, they don't have a specific number.
` One skilled in the art would understand this is an
` injection device where this is the population
` that's going to be using it, and you have to
` consider ergonomic functions when you're designing
` it.
` That's all part of the -- I forgot the
` word I used yesterday, but the ethos of the
` invention.
` Q. And that recognition of understanding
` ergonomics was well appreciated as of the priority
` date by those designing medical devices, wasn't it?
` A. I think that people do understand that.
` And then as products evolve, things get better and
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` SLOCUM
` better. So at the start, there is a -- yes, there
` is that understanding of this is what you want and
` technology keeps moving forward.
` Q. Okay. I don't want to quibble with your
` answer. You answered my question in the present
` tense, and I just want to make sure that I get a
` clear answer to my question. So I'm not
` criticizing the answer, I just want to make sure
` that you're answering the question I asked, okay?
` A. (Nodding head up and down).
` Q. Those developing and designing medical
` devices as of the priority date understood that
` they needed to account for ergonomic features in
` their designs, correct?
` A. Yes. I think that's in the background of
` the patents. Those dates, background clearly says
` this is what I'm trying to do, which -- so I don't
` recall if they specifically say ergonomics, but
` that's implied in there that, yes, you have to
` consider this.
` Q. Leaving aside the background section of
` the patent, though, people of ordinary skill in the
` art, medical -- I'm sorry -- mechanical engineers
` who were involved in designing medical devices
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` SLOCUM
` understood they needed to account for ergonomic
` features as of the priority date, correct?
` A. Yes, even before then, you always consider
` your intended user group.
` Q. Thank you.
` The next sentence is, "Specifically, the
` SoloSTAR has a maximum of 80 units, while the
` FlexPen only has a maximum of 60 units."
` Do you see that?
` A. I do.
` Q. The claims don't require any particular
` capacity in terms of insulin units, do they?
` A. They do not have a specific number
` mentioned.
` Q. And do you know of the universe of
` diabetic patients who take insulin, how many of
` them as a percentage require a single dose with
` greater than 60 units at one bolus?
` A. I don't know that.
` Q. You're not a medical doctor, right?
` A. Correct. So I just don't have that
` information at my fingertips.
` Q. The next sentence says, "While the
` SoloSTAR's dial would extend to 25.5 millimeters to
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` SLOCUM
` inject 60 units, the FlexPen must extend to
` 33 millimeters to inject 60 units."
` There's no requirements in the claim about
` a maximum millimeter extension to inject certain
` dose units, correct?
` A. Again, there's no specific numbers that
` are given.
` Q. And it looks like that's a difference of
` about 7 and a half millimeters; in American, that's
` about a third of an inch, roughly?
` A. American?
` Q. Our units, not SI units.
` A. I'm sorry. I work in SI units, so I guess
` I'm not very American, but that's okay. I'm
` ambiunitrous.
` Q. You said you were ambiunitrous yesterday.
` A. Yes, so I can do either.
` A third of an inch, or let's say 3/8ths of
` an inch, about. And 8 millimeters is 5/16ths to
` 3/8ths, so in that range.
` Q. Okay. You then go on to say, "All of
` these features are evidenced in the SoloSTAR
` injector pen which practices the inventions of the
` challenged claims."
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` SLOCUM
` And you've got opinions in here about how
` the SoloSTAR device meets the various limitations
` of the claims, right?
` A. That's a -- the latter portion of my
` opinions, I go through that.
` Q. Okay. And do you know if the SoloSTAR
` device changed at all during the period in which
` the SoloSTAR -- the Lantus SoloSTAR product was on
` the market?
` A. I only considered the current version that
` I had access to, and so the answer is I do not know
` what sort of small design changes or any design
` changes that would have been made throughout its
` history.
` Q. You didn't look at that?
` A. I did not consider that.
` Q. And do you know when -- do you know what
` version, if any version number was affiliated with
` the SoloSTAR device that you considered?
` A. Well, in general for a medical device, if
` you have a trade name and you're selling it, and
` then you go to do any substantiative change, now
` you have to clear that.
` So, for example, the FlexPen was the
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` SLOCUM
` FlexPen, they've made the lower force, cleaned up a
` few other things, and then it's the Next Generation
` FlexPen because typically, you have to do a
` refiling. So I don't know what was done, but I'm
` assuming SoloSTAR is and was SoloSTAR without
` anything substantiative. That's the only thing I
` can assume.
` Q. Okay. You go on to say, "The embodiments
` described in the challenged patents also show that
` these advantages can be realized by a small number
` of components, thereby enabling a device that can
` be manufactured at lower cost."
` Do you see that?
` A. I do.
` Q. And again, I think we may have hit this
` yesterday, but I just want to make it clear, that
` the claims that you considered are all comprising
` claims, which allows for additional elements beyond
` those that are specified in the claim itself,
` correct?
` A. That is my understanding of comprising.
` Q. And in terms of the lower cost, there is
` no cost feature or cost requirements, minimum or
` maximum, in the claims, right?
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` A. The claims do not give me a specific
` target number.
` Q. The final sentence in this section, "Also,
` because the pen is disposable, the components can
` be made of inexpensive materials, thereby further
` reducing the production costs."
` Let's parse that a little bit. With
` respect to the term "disposable," I think I
` mentioned yesterday there may have been a claim or
` two, dependent claim or two, which talks about
` disposability. But leaving those claims aside, is
` there any requirement in the claims that you
` considered here that the pen be disposable?
` A. Other than those claims you're talking
` about in the other ones, there was not a specific
` requirement for disposability.
` Q. Okay. And in terms of inexpensive, that
` the components can be made of inexpensive
` materials, is there any requirement in the claims
` about the type of material that needs to be used
` for any element of the injector pen devices?
` A. There would just be -- again, there's not
` a specific word of use this plastic, and for
` example, there could be in a dependent claim, but I
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` SLOCUM
` didn't see that.
` There is -- just, again, the user -- a
` POSA knows that you're trying to get low force
` ergonomic, et cetera, but particularly force. So
` as we were discussing yesterday, you would at least
` in the parts that are having relative motion,
` sliding, you would want to use things that are low
` cost, but also low friction.
` So this is the polyethylene/polypropylene
` combinations, for example, or specific formulations
` of them.
` Q. Yesterday you talked a little bit about
` the rig. Do you remember that testimony?
` A. The collar friction rig, yes.
` Q. Yes. I'm sorry, I refer to it as the rig
` I think because the first time you mentioned it to
` me, you called it the rig, so I don't want it to be
` the rig. But the collar friction device that you
` had -- saw at Weil's New York offices, right?
` A. And I'm happy from now on we just say the
` "the rig," that's what it means, that's easier.
` Q. Okay. So I think you said with the rig,
` you saw it was made of plastic and you looked at it
` and you said, gee, this isn't cheap stuff, right?
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` SLOCUM
` A. I don't know the exact things. It's not
` cheap stuff in terms of it wasn't just 3D-printed
` plastic, that's what I mean by cheap stuff.
` This was -- they were well-machined,
` smooth, easily back drivable, so that can be a
` polyethylene or a polypropylene. The cheap thing
` would be if they just 3D printed it. That's what I
` considered as the word "cheap," as in terms of low
` quality.
` Q. Okay. So by "inexpensive" here, you're
` not talking about low quality, you're talking about
` good stuff, just inexpensive?
` A. Well, like I said, a polypropylene or a
` polyethylene, if you pick the right formulation, is
` inexpensive and high quality. You can do
` inexpensive and low quality.
` Q. That's easy, right?
` A. That's easy.
` Q. Apart from the opinions that you've
` expressed here in paragraph 650, you have no
` further opinions regarding secondary considerations
` or a nexus between SoloSTAR versus the asserted
` claims of the patents here, right?
` MR. ANSLEY: Objection to form.
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` SLOCUM
` A. Well, 650 is where I'm talking about
` SoloSTAR, how it meets the requirements of the
` claims, and it sells well. That's my
` understanding. So that -- the extent of my
` opinions are here in my report.
` Q. And you don't in here talk about the sales
` of -- in your report at all talk about the sales of
` SoloSTAR, do you?
` A. I do not.
` Q. And you know, you understand that SoloSTAR
` is not sold separately from Lantus. If you buy
` SoloSTAR, you're buying Lantus as well in the
` SoloSTAR, right?
` MR. ANSLEY: Objection to form.
` A. My understanding -- this is my personal
` experience with my mother, is that when you buy an
` insulin injector pen, it's all together one.
` Q. It includes the medicament in it?
` A. Right. And that's why it's disposable.
` So this is not a class of refillable pen.
` Q. Did you talk to a medical doctor in
` connection with providing opinions about whether
` SoloSTAR practices the claims of the patents?
` A. I did not. I had a SoloSTAR. I had
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` SLOCUM
` pictures and took it apart and played with it and
` compared it to the claims. But I did not talk to a
` medical doctor.
` Q. Did you talk to anyone named Dr. Goland in
` connection with your work in the case?
` A. I think we had a phone call where he asked
` me about the SoloSTAR and the technical aspects of
` it. But I was not asking him about his medical --
` I don't even know if he is a medical doctor, maybe
` he is. The information was him asking me questions
` about the SoloSTAR construction or operation
` mechanically.
` Q. Do you remember this fellow's name, was it
` doctor or was it Grabowski that you're thinking of?
` A. Maybe it was Grabowski, I don't know. I
` may be mixing up. But there was a call where I was
` asked about the device mechanically, but I was not
` asking anybody about their opinions or input or
` anything that would have any bearing on anything I
` thought.
` Q. Okay. Do you recall if you talked to any
` other experts for Sanofi in this IPR?
` A. There was one man and one woman.
` Q. Okay.
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` A. I don't remember their names one way or
` the other.
` Q. Fair enough. Let's parse that.
` Can you tell me about the conversation you
` had with the man?
` A. I think both conversations were I was
` being asked questions, technical questions about
` the device. And that's the extent of my
` recollection.
` Q. What technical questions were you being
` asked?
` A. In terms of the -- here's the sole -- I
` think it was about the SoloSTAR. And is it
` practicing the claims of the invention or how it
` works. I don't recall exactly.
` Q. And how long did these conversations,
` these telephone calls last?
` A. 15, 20 minutes maybe.
` Q. Each or collectively?
` A. Probably each, 10, 15 minutes. I'm on the
` call, and the lawyers were introducing people or
` whatever. But the technical content is maybe 10,
` 15 minutes.
` Q. Okay. So you talked to a man and a woman?
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` A. That's my recollection, yes.
` Q. You talked to Rob Veasey a couple of
` times?
` A. Right, as we discussed yesterday, what I
` was discussing with him about, yes.
` Q. You talked to your assistant, Dr. Rojas,
` Folkers Rojas?
` A. Yes, as we discussed yesterday.
` Q. Apart from the lawyers, did you talk to
` anybody else about your work on this IPR?
` A. Remember Dr. Jonathan Slocum, I also had
` peer reviewing on my -- you know, I have him check
` my calculations, also. I tried to have, as I said,
` good peer review on my analysis. But I --
` Q. Dr. Jonathan Slocum, is that your brother?
` A. That's my son.
` Q. Your son? Oh, you had your son look at
` this. That's right. You did. Your son is the
` medical doctor as well, correct?
` A. No, no. That's Alexander Jr., he is the
` MD.
` Q. I see. Okay. I forgot about that.
` You talked to your son, Alexander Jr., the
` MD, about your work in the case?
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` A. No. Back up. I asked Alex Jr. about the
` afflictions, the comorbidity issues, and not
` telling him any details about this case.
` Dr. Jonathan Slocum, I'm having him review
` my lead screw calculations.
` Dr. Folkers Rojas reviewing my lead screw
` in that -- remember on the Burroughs, we talked
` about the thread. And he also under my direction
` helped complete the solid model.
` That's it.
` Q. So did either of your sons bill their time
` to Sanofi for the work that they did in discussing
` this with you?
` A. Not to Sanofi. I tell them to bill me,
` and it was a few hours each. And then I just -- I
` don't do any add on or anything. I pay them
` directly.
` Q. And then do you include that in the Sanofi
` invoice?
` A. I do. I include their time on that.
` Q. Okay. So we've got you talking to a man
` and a woman, you're talking to Dr. Veasey, you're
` talking to Dr. Rojas, you're talking to your two
` sons. Anyone else that you talked to apart from
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` the lawyers about your work in the case?
` A. Not that I can recall. Other than, you
` know, my wife knows I'm here and I'm working on
` things.
` Q. Of course.
` A. But she's a beekeeper who's not interested
` really in this.
` Q. All right. Let's talk about the Burroughs
` reference if we could.
` A. Okay.
` Q. Just so you've got it, I'm going to hand
` it to you.
` So Doctor, I've handed you Exhibit 1013,
` Burroughs '046 patent.
` Do you recognize this?
` A. I do.
` Q. Can you briefly explain to me how --
` MR. CARSTEN: Strike that. Let me start
` over.
` Q. This patent talks about an injector pen,
` correct?
` A. It does.
` Q. And can you briefly explain to me your
` understanding of how, when one patient presses the
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` button at the end of the device, how the forces go
` through the structures to expel medicament from the
` needle.
` A. Briefly, this device has no transmission
` in it. It's a direct coupling between your thumb
` and the plunger through the mechanism. So there's
` no particular intent here to give you a mechanical
` advantage. It 's a 1-to-1 machine.
` Q. Okay. Now, you understand that
` Mr. Leinsing opined about a modification to this
` device, correct?
` A. Yeah. In my report I go through several
` discussions about what he's talking about with
` respect to Burroughs.
` Q. And if you turn to your declaration at
` paragraph 171.
` A. Okay.
` Q. And here is where you've modified and
` annotated a figure out of the Burroughs reference
` to add what you believe is the second thread that
` Mr. Leinsing suggested, correct?
` A. Correct. I did that.
` Q. And where did you get the dimensions from
` the thread that you've added to this image?
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` A. So what I did here was essentially I'm
` taking the thread and flipping it so the thread it
` would engage would be in the same order as the
` thread that is already there. That is fairly
` typical for threaded engagement.
` Q. Okay. I understand your decision on
` location. I'm asking a different question.
` Why did you decide to duplicate the
` existing thread dimensions in the second thread?
` A. Well, I have here, I've illustrated -- if
` you want to look on page 117 of this modification
` below, using a cutaway of Burroughs Figure 7 and
` also provide Mr. Leinsing's annotations of
` Burroughs Figures 6 through 8 showing the proposed
` modification. That's on the other page.
` So it looks to me he did the same thing,
` and I'm just responding to his opinion of he says
` to do this.
` Q. You understand that Figure 6 through 8,
` the excerpt here, were on the fly at his deposition
` annotations, correct?
` MR. ANSLEY: Objection to form.
` A. He's an expert, and he did what I would
` have done, which is the thread size is about what
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` is already there. It makes perfect sense.
` Q. So your testimony then is that the bump at
` Figure 7, that red bump that's added at Figure 7 on
` page 118 of your report, is the same size as the
` existing thread?
` A. It's about.
` Q. Your testimony is that when you add the
` second thread in the way that you've done in -- at
` page 117 of your report, that the second thread
` would add friction and make the device wider,
` correct?
` A. Well, the first thing is, is when you do
` that, you have to, as I state on page 119 and then
` in my Appendix D, the first thing is you're going
` to -- this is this cascade -- the thread has to be
` able to be deflected out of the way. And in order
` to do that, you start changing dimensions. And
` this is where the wider device aspect comes in in
` order to accommodate that ability.
` Q. So you decided that a person of skill in
` the art would be motivated to, if they were going
` to implement a second thread, to make the device
` wider and, therefore, they would be disfavored; is
` that fair?
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` A. I wouldn't characterize it that way. If
` you're going to try this combination of adding a
` thread, you would do the analysis like I did,
` simple beam bending and do things fit. And if you
` still feel you want to do it, then in order to not
` have the plastics yield or forces go up, you can
` accommodate that by making the pen wider. So that
` would be the decision path.
` Q. That's your opinion as to the decision
` path that a person of skill in the art would have
` made?
` A. Yes, that is what a POSA would typically
` do.
` Q. Okay. I submit to you there's a different
` decision path, one that perhaps you didn't
` consider, and that is that instead of making the
` added thread precisely the same dimension as the
` existing thread, you might reduce the size of the
` added thread, correct?
` MR. ANSLEY: Objection to form.
` A. I don't have any opinions because no one
` gave me any information to analyze. But I do
` provide my spreadsheet and my analysis, which
` Mr. Leinsing didn't provide anything, so I can't
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` opine differently. But you're free to take what I
` did that was provided and do it and see if it
` works.
` Q. And the analysis that you did in Exhibit D
` assumes that the added thread has precisely the
` same dimensions of the existing thread, correct?
` A. That is incorrect. And I will show you.
` The height of the thread would be the same, it has
` to be because of the first thread if it's going to
` engage. The width of the thread, I put in
` variables, and the variable is defining the pitch,
` that has to stay the same.
` Now, if you want to change other features
` of the actual tooth itself, I didn't need to
` consider that aspect. But the pitch and the
` height, those are fixed by the design that is
` there.
` Q. And what page are you referring to when
` you say that you considered alternate widths, the
` page that you were just looking at, sir?
` A. I didn't consider alternate widths. If
` you go to 2107.392, that's the FEA model. That's
` my PowerPointed figure that is also used for the
` FEA model. Remember we talked about this
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` yesterday. And then Appendix F has my spreadsheet.
` And you can see those dimensions, the L1 and L2, X1
` and X2, you can see that all here on page 397. And
` if you go to 398, is my scaling. The pitch there
` comes from -- you'd have to go to the other
` commensurate figure of the mate. And that's about
` right for the pitch.
` Q. So am I right that you did not consider
` alternative widths then?
` A. I just used the pitch that's already there
` in the patent. I didn't change the pitch of the
` thread that these teeth would have to mate with.
` Q. Now, you understand, though, a person of
` ordinary skill in the art as of the priority date
` would be free to change the height as well as
` change the width of the added thread if he or she
` so desired, correct?
` A. I disagree with that.
` Q. Okay. With respect to the analysis that
` we talked about, I think you just identified a
` couple of pages, but I thought that if you look
` in -- so for example, Appendix F, which is analysis
` of Leinsing new tooth, I'm looking at 2107.395, but
` it includes some of the pages that you just cited
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` to. How long did it take you to do the
` spreadsheets and come out with data?
` A. Oh, this was an hour or two kind of thing.
` If you look on page 2107.380, you can see right
` there, this is the sketch of the math and I will
` transcribe my chicken scratch. Excuse me again,
` I'm dysgraphic so I don't have the best of
` handwriting and things. But anyway you see where I
` have drawn out those points A, B, X1, S up over on
` the left side. The dominant mode is beam subject
` to moment and force and then the beam element B is
` not really loaded, it's just a free lever. So in
` other words, where the teeth are is not -- are not
` subject to loads, that's just a lever that they
` pivot down on. The actual beam bending occurs over
` L1 and a little bit of L2 on the top distance.
` Do you see that?
` Q. Uh-huh.
` A. Now, it's just sophomore beam bending. So
` I sketch this, all those -- the scans of this is
` contained in the spreadsheet, the beam equation,
` the slope. We could redo it now if you want, it's
` very simple. And then deflection of a beam is FL
` cubed over 3EI. Slope FL squared over 2EI, that's