throbber
Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` - - - - - - - - - - - - - - - - - -
` MYLAN PHARMACEUTICALS INC.
` and PFIZER INC.,
` Petitioners,
` v.
` SANOFI-AVENTIS DEUTSCHLAND GMBH,
` Patent Owner.
`
` - - - - - - - - - - - - - - - - - -
`VOLUME I Pages 1-109
` Case IPR2018-01670
` Case IPR2018-01678
` Case IPR2018-01675
` Case IPR2018-01676
` 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 KARL ROBERT LEINSING, MSME, P.E.
` Thursday, October 10, 2019, 8:57 a.m.
` Sheraton Portsmouth Harborside Hotel
` 250 Market Street
` Portsmouth, New Hampshire 03801
`-- Reporter: Kimberly A. Smith, CSR CRR, CRC, RDR --
` Realtime Systems Administrator
` Alderson Court Reporting
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.001
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 2
`
`APPEARANCES:
`
` Wilson Sonsini Goodrich & Rosati, P.C.
`
` By: Richard Torczon, Esq.
`
` and Tasha Thomas, Esq.
`
` 1700 K Street, N.W., Fifth Floor
`
` Washington, D.C. 20006-3814
`
` (202) 973-8800
`
` rtorczon@wsgr.com
`
` tthomas@wsgr.com
`
` for the Petitioner Mylan
`
` Pharmaceuticals Inc.;
`
` Winston & Strawn LLP
`
` By: Jovial Wong, Esq.
`
` 1700 K Street, N.W.
`
` Washington, D.C. 20006
`
` (202) 282-5000
`
` jwong@winston.com
`
` for the Petitioner Pfizer, Inc.
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.002
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 3
`
`APPEARANCES: (continued)
`
` Weil, Gotshal & Manges LLP
`
` By: Sutton Ansley, Esq.
`
` 2001 M Street, N.W., Suite 600
`
` Washington, D.C. 20036
`
` (202) 682-7000
`
` sutton.ansley@weil.com
`
` and
`
` Weil, Gotshal & Manges LLP
`
` By: Anish Desai, Esq.
`
` 767 Fifth Avenue
`
` New York, NY 10153-0119
`
` (212) 310-8000
`
` anish.desai@weil.com
`
` and
`
` Fish & Richardson, P.C.
`
` By: Matt Colvin, Esq.
`
` 601 Lexington Avenue, 52nd Floor
`
` New York, NY 10022
`
` (212) 765-5070
`
` colvin@fr.com
`
` and
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.003
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 4
`
`APPEARANCES: (continued)
`
` Fish & Richardson, P.C.
`
` By: John S. Goetz, Esq.
`
` 1717 Main Street, Suite 5000
`
` Dallas, TX 75201
`
` (214) 747-5070
`
` goetz@fr.com
`
` for the Patent Owner.
`
`Also Present: Matthew Greinert, Esq., Mylan
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.004
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 5
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` I N D E X
`
`WITNESS: Karl Robert Leinsing, MSME, P.E.
`
`EXAMINATION Page
`
` By Mr. Ansley 7
`
` By Mr. Colvin 45
`
` AFTERNOON SESSION
`
` By Mr. Colvin 92
`
`EXHIBITS FOR IDENTIFICATION:
`
`Mylan Description Page
`
`Exhibit 1001 U.S. Patent 8,679,069 22
`
`Exhibit 1002 U.S. Patent 8,603,044 22
`
`Exhibit 1003 U.S. Patent 8,992,486 32
`
`Exhibit 1004 U.S. Patent 9,526,844 22
`
`Exhibit 1005 U.S. Patent 9,604,008 22
`
`Exhibit 1014 U.S. Patent 6,235,004 99
`
`Exhibit 1016 U.S. Patent 6,932,794 37
`
`Exhibit 1095 9/18/19 Leinsing reply 8
`
` declaration
`
`Exhibit 1096 9/18/19 Leinsing declaration 45
`
` in support of petitioners'
`
` oppositions to Sanofi's
`
` motion to amend
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.005
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 6
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`EXHIBITS FOR IDENTIFICATION: (continued)
`
`Mylan Description Page
`
`Exhibit 1097 PCT WO 02/092153 101
`
`Exhibit 1105 U.S. Patent 6,277,099 93
`
`Original exhibits retained by reporter to be
`
`returned to Weil, Gotshal & Manges
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.006
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 7
`
` KARL ROBERT LEINSING, MSME, P.E.,
`
` having been first duly sworn by the court
`
` reporter, was deposed and testified as follows:
`
` EXAMINATION
`
`BY MR. ANSLEY:
`
` Q. Good morning.
`
` A. Good morning.
`
` Q. Could you please state your name for the
`
`record.
`
` A. Karl Robert Leinsing.
`
` Q. What is your mailing address?
`
` A. 77 Spur Road, Dover, New Hampshire 03820.
`
` Q. And you understand that you're under oath
`
`today to give truthful testimony; is that correct?
`
` A. Yes.
`
` Q. And is there any question you can't give
`
`truthful testimony today?
`
` A. No.
`
` Q. And you understand that you're here to be
`
`deposed on a reply declaration that you executed on
`
`September 18; is that right?
`
` A. That's correct.
`
` Q. I have a copy of that I'll hand you. It's
`
`Exhibit 1095. There you are.
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`24
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.007
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 8
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` (Mylan Exhibit 1095 was presented
`
` to the witness.)
`
` MR. TORCZON: Objection, foundation.
`
` Q. And Exhibit 1095 that I just handed you,
`
`you can see on page 106, there's a signature there.
`
` Do you see that?
`
` A. Yes.
`
` Q. And you executed this on September 18,
`
`right?
`
` A. Yes.
`
` Q. And this appears to be the reply declaration
`
`that you submitted in the nine IPRs between Sanofi
`
`and Mylan; is that right?
`
` A. Actually, no. The page 55 and some other
`
`ones, something happened, I think, with the PDF
`
`because there's a lot of the text missing.
`
` Q. 55?
`
` A. 15. I'm sorry.
`
` Q. 15. What text is missing on page 15?
`
` A. I believe counsel sent you an updated
`
`version or something yesterday. There's some text
`
`missing that identified the different parts of the
`
`figure on page 15. And then there's some other
`
`figures like that, something about them, because I
`
`think they're colored or something, they got
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.008
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 9
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`truncated off by Adobe PDFMaker.
`
` Q. When you reviewed and signed this
`
`declaration on September 18, that included the
`
`declaration with the image and the text on page 15,
`
`correct?
`
` A. It had it but it, I think, somehow just
`
`disappeared.
`
` Q. You mentioned a declaration that was served
`
`last night; is that correct?
`
` A. Yes.
`
` Q. And what is the signature date on that
`
`declaration?
`
` A. Yesterday.
`
` Q. October 9; is that right?
`
` A. Yes.
`
` Q. And are there any differences other than
`
`what's shown on page 15 between the two declarations
`
`on October 9 and September 18?
`
` A. Yes. There's other pages. I'm not sure
`
`which all were messed up from the PDF, but I think
`
`the figure on page 81, possibly the figure on
`
`page 82. Maybe the figure on 22. And on page 17.
`
` Q. Let me ask this.
`
` A. This is not a colored copy either. My
`
`original one was colored, which makes it easier to
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.009
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 10
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`see the different features.
`
` Q. Let me ask you this. Other than the
`
`figures, are there any differences in the text in
`
`the paragraphs between the September 18 declaration
`
`and the October 9 declaration?
`
` A. No. Just the figures or the annotations in
`
`the figures.
`
` Q. Okay.
`
` A. And, of course, the figures are colored in
`
`what I presented. The one you gave me here today is
`
`black-and-white.
`
` Q. Well, I think the black-and-white version
`
`is the one that was filed with the PTO. But is it
`
`all right if I just refer to your -- both
`
`declarations collectively as your reply declaration
`
`for today's purposes?
`
` A. Well, no. Because the reply declaration I
`
`gave is the one with everything annotated. So the
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`one yesterday is my reply declaration.
`
` Q. Okay. Again, the only differences are with
`
`the color of the figures and apparently there's some
`
`annotations missing in Exhibit 1095 allegedly; is
`
`that right?
`
` A. Yes.
`
` Q. Well, I'm just going to refer to these
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.010
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 11
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`collectively as the reply declaration unless we
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`refer specifically to the figures, and then we can
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`make the distinction there if that matters, okay?
`
` A. Okay.
`
` Q. Now, do you recall being previously deposed
`
`with respect to these nine IPRs?
`
` A. Yes.
`
` Q. And that deposition was on June 3 and 4 of
`
`this year, right?
`
` A. I don't recall the dates, but we met here
`
`in Portsmouth.
`
` Q. And between then and now, have you been
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`deposed at all?
`
` A. For this case?
`
` Q. Any case.
`
` A. Yes.
`
` Q. About how many times?
`
` A. I don't recall. Maybe a couple.
`
` Q. Two or three; does that sound right?
`
` A. A couple. There was one for like an hour.
`
`And I might have done one other. I don't recall.
`
` Q. Were these depositions, these one or two
`
`depositions, were they for a patent litigation case?
`
` A. Yes.
`
` Q. And were you serving as an expert witness
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.011
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 12
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`in both of these or --
`
` A. Yes.
`
` Q. -- the couple that you recall?
`
` Do you recall the name of those cases?
`
` A. One of them is the Covidien vs. Ethicon
`
`case.
`
` Q. And what were the others?
`
` A. I think there was just one other. It was
`
`Medline vs. C.R. Bard.
`
` Q. How do you spell that, the second party?
`
` A. C.R. Bard? It's initial C.R. -- or you can
`
`just say Bard, B-a-r-d.
`
` Q. And the first case, Covidien vs. Ethicon,
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`what district is that? IPR? District Court?
`
` A. Now you're asking me legal things. I think
`
`that was District Court of Massachusetts.
`
` Q. And what about the Medline vs. Bard matter?
`
`Is that an IPR case or a District Court case?
`
` A. That's a District Court case, I believe.
`
` Q. So what did you do to prepare for today's
`
`deposition?
`
` A. I reviewed my two declarations and some
`
`reports, reviewed some deposition transcripts from
`
`Dr. Slocum, my deposition transcript from the
`
`previous time we met in June. And I met in person
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.012
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 13
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`with counsel yesterday. And I reviewed the patents
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`and the prior art.
`
` Q. When you say your two declarations, are you
`
`referring to your opening declaration that was
`
`submitted with the petitions and your reply
`
`declaration?
`
` A. Yes. Actually, three. So it would be my
`
`first big declaration, that 487-page one.
`
` Q. Um-hum.
`
` A. And then I guess that's the opening
`
`declaration. And then there was the reply
`
`declaration. And then there's the reply to the
`
`amended claims.
`
` Q. Understood. And when you met yesterday
`
`with counsel, how long did that meeting last?
`
` MR. TORCZON: Objection, relevance.
`
` A. It was about eight hours or so.
`
` Q. And what counsel specifically are you
`
`referring to?
`
` A. Everybody to my left.
`
` Q. And were there any non-attorneys in that
`
`meeting?
`
` A. No. Other than the lunch lady.
`
` Q. The reply declaration that's Exhibit 1095
`
`in front of you or alternatively the one you signed
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.013
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 14
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`last night, it's the same declaration for all nine
`
`IPR proceedings; is that right?
`
` A. Can you repeat that, please.
`
` Q. Well, let's take first Exhibit 1095 that's
`
`in front of you. Is that the same declaration that
`
`was submitted in all nine IPR proceedings?
`
` A. That was submitted in all nine IPR . . .
`
` Q. Um-hum.
`
` A. I don't know whether -- it's not -- I don't
`
`understand your question.
`
` Q. I guess my question is, there's only one
`
`September 18, 2019 reply declaration for the five
`
`challenged patents; is that correct?
`
` A. Yes, that's correct. One reply to those.
`
`I don't know -- I still don't quite understand what
`
`you're saying. I mean, this is the one that goes to
`
`your reply, and then there's another one that goes
`
`to amendments to those claims. So that's related as
`
`well to the same ones.
`
` Q. That's fine. And then the one you signed
`
`last night, the October 9 declaration, that's the
`
`same declaration for all nine IPR proceedings;
`
`is that correct?
`
` In other words, you don't have different
`
`versions of a reply declaration for different IPR
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.014
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 15
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`proceedings, correct?
`
` MR. TORCZON: Objection, form.
`
` A. Yeah. There's one declaration that's
`
`covering all of those petitions.
`
` Q. Okay.
`
` A. I mean, there's different declarations for
`
`different aspects of those replies.
`
` Q. Sure. And when did you start working on
`
`your reply declaration that's Exhibit 1095?
`
` MR. TORCZON: Objection, relevance.
`
` A. I don't remember the dates. I mean,
`
`between this case and the District Court case,
`
`everything's kind of getting mixed together.
`
` Q. Was it after the patent owner submitted
`
`their patent owner responses?
`
` A. Well, yeah, naturally.
`
` Q. And about how many hours approximately have
`
`you spent working on this reply declaration?
`
` A. I don't recall how much time. Not nearly
`
`as much as the first one.
`
` Q. So 40 hours for some is a typical workweek.
`
`Was it more than 40 hours or less than 40 hours?
`
` A. I couldn't tell you. I don't recall.
`
` Q. Well, all the statements in Exhibit 1095,
`
`those are your statements?
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.015
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 16
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` A. Yes. I -- I signed the back of it, so
`
`everything is true to my knowledge, other than the
`
`things I told you that were incorrect on the one you
`
`just gave me.
`
` Q. And all the opinions are your opinions too;
`
`is that fair?
`
` A. Yes.
`
` Q. Could you look at paragraph 2 of
`
`Exhibit 1095. So here you state that in preparing
`
`your declaration, you considered Sanofi's patent
`
`owner responses, Dr. Slocum's declaration, his
`
`deposition testimony, and then materials listed in
`
`the back in Appendix A.
`
` Do you see that?
`
` MR. TORCZON: Objection, form.
`
` A. Yes.
`
` Q. Did you consider any other materials in
`
`forming the opinions contained in this declaration?
`
` A. Repeat that, please.
`
` Q. Did you consider any other materials other
`
`than what you've identified in paragraph 2 in
`
`forming the opinions contained in this declaration?
`
` A. No. I think everything I considered is
`
`listed in the declaration.
`
` Q. And other than the attorneys representing
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.016
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 17
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`Mylan or Pfizer, did you speak with anyone as part
`
`of preparing this declaration?
`
` A. No.
`
` Q. And are you relying on any statements from
`
`any individuals other than the attorneys
`
`representing Mylan or Pfizer for any of the opinions
`
`or statements offered in this declaration?
`
` A. No.
`
` Q. For any of the statements in this
`
`declaration, are you relying on any mathematical
`
`calculations that you performed?
`
` A. If there was anything that I relied on, I
`
`would have listed it here. I did make some entries
`
`into Dr. Slocum's spreadsheet when I was reviewing
`
`his -- his responses, which then resulted in some of
`
`my opinions.
`
` Q. Did you do anything else in the way of
`
`mathematical calculations for forming the opinions
`
`contained in this declaration?
`
` A. I can't recall -- I can't recall at this
`
`time. Just making changes to those spreadsheets.
`
`And I think I mentioned that in the declaration.
`
` Q. So let's talk a little bit about some of
`
`the entries that you changed in Dr. Slocum's
`
`spreadsheet. What inputs or values did you change?
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.017
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 18
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` A. I changed quite a few of them, at least
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`75 percent, to verify his calculations. And then
`
`primarily the ones that were pertinent to my
`
`opinions were the values of friction, the diameter
`
`numbers that he was using, and particularly with my
`
`statements on adding a collar to the driver, and
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`then changed some of the amount of pitch on some of
`
`the leads to show that forces can be reduced in
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`different ways that Dr. Slocum did not opine on.
`
` Q. Do you have any record of the changes or
`
`different values that you input into Dr. Slocum's
`
`spreadsheet?
`
` A. I didn't save the spreadsheet because I
`
`wanted to preserve them in Dr. Slocum's original
`
`form, but I made note of what things could be
`
`changed, and I believe I have some diameter numbers
`
`that I input that would decrease the frictional
`
`forces that he seemed to be concerned about.
`
` Q. And do you have notation of the changes
`
`that you were making and then the outcome of those
`
`changes, or the output on the spreadsheet?
`
` A. I don't think I saved or made note of what
`
`the output was. I just said what the numbers he
`
`could input if he was concerned about that.
`
` And then I think in his deposition, he
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.018
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 19
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`had admitted that there were some lower friction
`
`numbers that could be used, and that was sufficient
`
`for my analysis.
`
` Q. Have you designed or developed any
`
`physical, virtual, or mathematical models regarding
`
`any of the obviousness grounds in this matter or
`
`regarding any of Sanofi's opposition arguments?
`
` A. Can you repeat that.
`
` Q. Yeah, let me break it down. Have you
`
`designed any -- or developed any physical models to
`
`support any of the opinions or with respect to any
`
`of the opinions you offer in this reply declaration?
`
` A. I created a 3-D model to understand the
`
`reverse threads and some of the way the device works
`
`to have something in my hand because I couldn't
`
`understand how the patents-in-suit, as they weren't
`
`very well enabling, to understand how the device
`
`operated.
`
` Q. When you say "reverse threads," are you
`
`talking about a piston rod that has oppositely
`
`disposed threads?
`
` A. Yes.
`
` Q. And so you created a 3-D model of at least
`
`a piston rod with obsolete disposed threads, for
`
`example, as shown in the challenged patents; is that
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.019
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 20
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`right?
`
` A. Yes.
`
` Q. And was that a 3-D printed model?
`
` A. Yes.
`
` Q. And what other components did you 3-D print
`
`along with the piston rod?
`
` A. I made two -- basically cylinders with a --
`
`or tubes with threads that match each of the two
`
`threads. So I basically had three parts.
`
` Q. And did you make any -- did you 3-D print
`
`anything else as part of this physical model?
`
` A. No.
`
` Q. And what again was the purpose of this
`
`model?
`
` A. It was to understand the two different
`
`threads and then there were claims in the patent
`
`about the insert -- I can't think of the term, I
`
`think it was to hold or prevent movement on its own.
`
`And I couldn't see how that was happening.
`
` And then even with the reverse threads,
`
`I had questions on whether even that would prevent
`
`the piston rod from backing away from the cartridge.
`
` Q. So what opinions in your reply declaration
`
`is this physical model relevant to?
`
` A. I can't recall on the reply declaration
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.020
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 21
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`what parts that would be. I think it was -- it's
`
`more on the modifications to, I think, some of the
`
`claims. And now come to think of it, I might have
`
`actually made it more to help with the District
`
`Court case.
`
` Q. So this model was made for the District
`
`Court case and not for the IPRs; is that correct?
`
` MR. TORCZON: Objection, scope.
`
` A. I still use it to look at it, just to
`
`understand the reverse threads. I'm not sure
`
`exactly, sitting here now, without looking at the
`
`specifics, where that helped to understand certain
`
`parts. But it was always -- it was just nice to
`
`have something to hold in my hand when reviewing the
`
`patents-in-suit versus the prior art.
`
` Q. But right now, you can't think of how this
`
`model, this 3-D printed model, supports any of the
`
`opinions in your reply declaration; is that right?
`
` A. I mean, I think I used it to understand the
`
`different threads, particularly with looking at some
`
`of the claims relating to that. It might have been
`
`with Burroughs. I think sections of Steenfeldt-
`
`Jensen and incorporating those into Møller and
`
`different other aspects, it was just nice to have a
`
`model to hold in my hand as I'm analyzing the
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.021
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 22
`
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`patents and the prior art.
`
` Q. Well, perhaps we need to go through your
`
`reply declaration then and test this out.
`
` So one of the things you mentioned is
`
`that this model may have been relevant to some of
`
`the claims. Are you referring to some of the claims
`
`of the challenged patents?
`
` A. Yes.
`
` Q. And which claims specifically? I can go
`
`ahead and hand you the challenged patents so you
`
`have them in front of you. '069. There you go.
`
`'044. Here's the '844. And lastly, here's the '008.
`
` (Mylan Exhibit 1001 was presented
`
` to the witness.)
`
` (Mylan Exhibit 1002 was presented
`
` to the witness.)
`
` (Mylan Exhibit 1004 was presented
`
` to the witness.)
`
` (Mylan Exhibit 1005 was presented
`
` to the witness.)
`
` Q. Before we go through any of these claims,
`
`your reply declaration doesn't mention this 3-D
`
`printed model anywhere; is that correct?
`
` A. No, I don't think so.
`
` Q. So you have the patents in front of you.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.022
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 23
`
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` MR. TORCZON: Objection, foundation.
`
` Q. Which of these claims is this 3-D printed
`
`model relevant to?
`
` A. I think rather than -- I mean, if you want
`
`me to spend -- it would probably take me a half hour
`
`to figure out exactly which claims and read through
`
`every one.
`
` I think it would be best to just tell
`
`you that the model is more of a general
`
`understanding of how to try to understand the way
`
`the reverse threads work on the piston rod and their
`
`mating components in a general sense across the
`
`different claims. It was just more for my
`
`understanding of the challenged patents.
`
` But if you want me to go through and
`
`look at which ones that the claims talk about -- so
`
`any of the claims that talk about piston rod and
`
`threads and their mating components, it would relate
`
`to that and just a general understanding.
`
` Q. One of the prior pieces you mentioned was
`
`Burroughs. Does Burroughs have reverse threads on a
`
`piston rod?
`
` A. No, it doesn't. But we talk about
`
`different aspects of Burroughs, and I think having
`
`different threads. So it was just a -- again, a
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.023
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 24
`
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`handheld tool that I could look at that has threads.
`
` Q. We might come back to that. Other than the
`
`3-D printed model, did you develop any other
`
`physical models regarding any of the obviousness
`
`grounds or Sanofi's opposition arguments for
`
`purposes of preparing your declaration?
`
` A. No, I didn't think it was necessary.
`
` Q. Did you develop or design any virtual --
`
`and by that I mean CAD model, solid model, a wire
`
`frame model -- for purposes of developing your
`
`declaration?
`
` A. No. Again, it wasn't necessary.
`
` Q. And, again, the only mathematical model
`
`that you considered for purposes of your declaration
`
`was the changes you made to Dr. Slocum's
`
`spreadsheet; is that right?
`
` A. I don't know if I want to say "considered."
`
`I reviewed them because my declaration was in
`
`response to his work with those spreadsheets.
`
` Q. But you, yourself didn't generate any
`
`mathematical models; is that correct?
`
` A. No, I did not.
`
` Q. And did you perform any physical
`
`inspections of any pen injectors in preparing your
`
`reply declaration?
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.024
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 25
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` A. I had looked at the Mylan pen injector.
`
`I think that was the only one I looked at. And then
`
`I had recently looked at the FlexPen. But I'm not
`
`sure which was for which declaration or report.
`
`I've been working on both cases.
`
` Q. Any other pen injectors?
`
` A. No.
`
` Q. The FlexPen that you looked at, do you know
`
`the difference between the FlexPen that was released
`
`in the early 2000s and the FlexPen that was termed
`
`the next generation FlexPen?
`
` MR. TORCZON: Objection, scope.
`
` A. I mean, I'm aware there was changes made to
`
`the FlexPen, but I'm not sure what the dates were
`
`and when different things were implemented.
`
` And I think in 2006 or '7, just after,
`
`there was some studies on force of activation, they
`
`reduced that force of activation with their push
`
`button design and made improvements with that to
`
`improve that and fix that problem.
`
` Q. And the FlexPen that you examined, was this
`
`a FlexPen from the early 2000s or was this a FlexPen
`
`after the changes had been made to certain aspects
`
`of the design?
`
` MR. TORCZON: Objection, scope.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.025
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Karl Robert Leinsing, MSME, P.E.
`
`Portsmouth, NH
`
`10/10/2019
`Page 26
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`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. I had looked at and reviewed both pre and
`
`post. But the ones I worked on the most in my hands
`
`were the more recent ones with the changes.
`
` Q. And when you said you had looked at the
`
`pre design change FlexPen, when did you perform that
`
`examination?
`
` MR. TORCZON: Objection, scope.
`
` A. Roughly a year, year and a half ago.
`
` Q. And do you still have access to that pen
`
`injector?
`
` MR. TORCZON: Objection, scope.
`
` A. No.
`
` Q. Why not?
`
` MR. TORCZON: Objection, scope.
`
` A. I was asked to give it back.
`
` Q. Give it back to whom?
`
` MR. TORCZON: Objection, scope.
`
` A. Novo-Nordisk.
`
` Q. Did you examine this as part of a
`
`consulting arrangement with Novo Nordisk?
`
` MR. TORCZON: Objection, scope.
`
` A. Yes.
`
` Q. More recently you said you've examined the
`
`more recent FlexPen, the one with the design changes.
`
`When was the last time you performed a physical
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2316.026
`Mylan v. Sanofi
`I

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