Karl R. Leinsing, MSME, PE (Vol. II)
`
`Portsmouth, NH
`
`6/4/2019
`Page I (208)
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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 IPR2018-01675
`
`Case IPR2018-01676
`
`Case IPR2018-01678
`
`Case IPR2018-01680
`
`VOLUME II
`
`VIDEO DEPOSITION of KARL R. LEINSING, MSME, PE
`
`Portsmouth, New Hampshire
`
`Tuesday, June 4, 2019
`
`Reported by:
`
`Dana Welch, CSR, RPR, CRR, CRC
`
`Job #86101
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2164.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing, MSME, PE (Vol. II)
`
`Portsmouth, NH
`Page 209
`
`6/4/2019
`Page 2 (209 - 212)
`Page 211
`
`1 APPEARANCES (CONT'D)
`2 For the Patent Owner:
`3 FISH & RICHARDSON
`4 BY: JOHN S. GOETZ, ESQ.
`5 601 Lexington Avenue, 52nd Floor
`6 New York, NY 10022-4611
`7 goetz@fr.com
`8
`9 For the Petitioner:
`10 WILSON SONSINI GOODRICH & ROSA TI
`11 BY: RICHARD TORCZON, ESQ.
`12 WESLEY E. DERRYBERRY, ESQ.
`13 1700 K Street NW, Fifth Floor
`14 Washington, DC 20006
`15 rtorczon@wsgr.com
`16 wderryberry@wsgr.com
`17 -- and --
`18 WILSON SONSINI GOODRICH & ROSA TI
`19 BY: NATHANIEL SHARN, ESQ.
`20 12235 El Camino Real
`21 San Diego, CA 92130
`22 nscham@wsgr.com
`23
`24 Also Present: Matthew Greinert (Mylan)
`Jovial Wong, Esq., Winston & Strawn
`25
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`Page 210
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`Page 212
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`INDEX
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`1
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`2
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`3
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`4
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`5
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`6
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`7
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`8
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`June 4, 2019
`8:57 a.m.
`
`Deposition of KARL R. LEINSING, MSME, PE,
`9
`10 held at Hampton Inn & Suites Portsmouth Downtown,
`11 23 Portwalk Place, Portsmouth, New Hampshire 03801,
`12 before Dana Welch, Licensed Shorthand Reporter
`13 (NH#l 18), Registered Professional Reporter,
`14 Certified Realtime Reporter and Notary Public of
`15 the State of New Hampshire.
`
`16
`
`17
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`18
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`19
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`20
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`21
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`22
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`23
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`24
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`25
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`1 APPEARANCES:
`2 For the Patent Owner:
`3 WEIL, GOTSHAL & MANGES
`4 BY: SUTTON ANSLEY, ESQ.
`5 MATTHEW D. SIEGER, ESQ.
`6 2001 M Street, NW, Suite 600
`7 Washington, DC 20036
`8 sutton.ansley@weil.com
`9 matthew. si eger@weil.com
`10 -- and --
`11 SUDIP KUNDU, ESQ.
`12 767 Fifth Avenue
`13 New York, New York 10153
`14 sudi p .kundu@weil.com
`15
`16 For the Patent Owner:
`17 FISH & RICHARDSON
`18 BY: MATTHEW COLVIN, ESQ.
`19 1717 Main Street, Suite 5000
`20 Dallas, TX 75201
`21 col vin@fr.com
`22
`
`23
`24 --- appearances continue ---
`25
`
`1
`2 WITNESS:
`3 KARL R. LEINSING, MSME, PE
`4
`5 EXAMINATION:
`6 BY MR. ANSLEY
`7 BY MR. COL VIN
`8 BY MR. GOETZ
`9 EXHIBITS MARKED:
`PAGE:
`10 NO. DESCRIPTION
`11 Exhibit 2104, Figure 5, Mylan Exhibit
`252
`1003, U.S. Patent 8,992,486
`12
`254
`13 Exhibit 2105, Handwritten drawing
`351
`14 Exhibit 2106, Sheet 9 of 9, August 23,
`15 2005, U.S. 6,932,794, Mylan Exhibit 1016
`16
`17 EXHIBITS PREVIOUSLY MARKED:
`18 Exhibit 1003, U.S. Patent 8,992,486
`19 Exhibit 1005, U.S. Patent 9,604,008
`20 Exhibit 1012, Curriculum Vitae Karl R.
`21 Leinsing, MSME, PE
`22 Exhibit 1013, U.S. Patent 6,221,046
`23 Exhibit 1014, U.S. Patent 6,235,004 -
`24 Steenfeldt-Jensen
`--- index continues ---
`25
`
`PAGE:
`214
`240
`306
`
`241
`338
`384
`
`236
`220
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2164.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing, MSME, PE (Vol. II)
`
`Portsmouth, NH
`Page 213
`
`6/4/2019
`Page 3 (213 - 216)
`Page 215
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`1
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`2
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`3
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`4
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`8
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`this review?
`A. About two hours or so.
`Q. Okay.
`A. I don't recall exactly.
`Q. And did you review them by yourself or
`5
`6 with others present?
`A. By myself.
`7
`Q. Okay. And when you said you reviewed the
`9 prior art, you're referring to the -- one of the
`10 Burroughs, Steenfeldt-Jensen, Moller, Klitgaard, or
`11 Giambattista references, correct?
`A. Correct.
`12
`Q. Okay. And when you refer to the exhibits
`in your declaration, are there -- what exhibits
`from pages 471 to 473 did you review?
`A. All of them.
`Q. You re-reviewed all of Exhibits 1001
`through 1034; is that correct?
`A. Yes, except the file histories. I at
`19
`2 o least opened up every single file and just reviewed
`it.
`21
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`13
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`14
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`15
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`16
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`17
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`18
`
`Q. Okay. During the breaks yesterday, did
`22
`2 3 you have any discussions with counsel about the
`substance of your testimony?
`A. No.
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`25
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`24
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`1
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`5
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`6
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`12
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`PROCEEDINGS
`KARL R. LEINSING, MSME, PE
`having been previously sworn on oath,
`3
`4 continued to testify as follows:
`EXAMINATION
`5
`6 BY MR. ANSLEY:
`Q. We can go on.
`7
`Good morning.
`A. Good morning.
`Q. Welcome back, Mr. Leinsing.
`A. Leinsing.
`Q. Leinsing?
`A. Line (phonetic), like stein, Leinsing.
`Q. Oh, I'm sorry. I hope I haven't been
`14
`15 saying that incorrectly the entire time.
`Leinsing.
`16
`After the deposition ended for the day
`17
`18 yesterday, did you do anything to prepare for your
`testimony today?
`A. Yes.
`Q. What did you do?
`A. I just reviewed some of the exhibits on my
`22
`2 3 declaration and reviewed the prior art references,
`just skimmed through them.
`24
`Q. And how much time did you spend performing 25
`
`INDEX (CONT'D)
`1
`2 EXHIBITS PREVIOUSLY MARKED:
`3 Exhibit 1015, U.S. Patent Application
`2002/0052578
`4
`5 Exhibit 1016, U.S. Patent 6,932,794
`6 Exhibit 1017, U.S. Patent 6,582,404
`7
`
`234
`
`335
`306
`
`8 NOTATIONS:
`9 Time marked by Mr. Goetz: 4:40 p.m.
`10
`
`353
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`11
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`12
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`13
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`14
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`15
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`16
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`21
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`2 3
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`Page 214
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`Page 216
`Q. Okay. And after the testimony concluded
`2 yesterday evening, did you have any discussions
`3 with counsel -- and until this morning, did you
`4 have any discussions with counsel about the
`substance of your testimony?
`A. No.
`Q. All right. I'd like to refer you to a
`8 portion of your declaration beginning on paragraph
`9 258.
`A. Did you say page 258?
`Q. Paragraph 258. Let me know when you're
`there.
`A. I'm there.
`Q. Okay. And in this section that begins
`14
`15 with paragraph 258, and continues, I believe,
`through paragraph 338, you provide your opinion
`that the challenged claims of the '06 9, '044, and
`'486 patent are obvious over Steenfeldt-Jensen; is
`that correct?
`MR. TORCZON: Objection, form.
`A. We should probably do the table of
`21
`22 contents, like you were asking me yesterday.
`Q. Okay.
`23
`A. Regarding Steenfeldt-Jensen, all of my
`opinions using that prior art would include the
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`20
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2164.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing, MSME, PE (Vol. II)
`
`Portsmouth, NH
`Page 217
`
`6/4/2019
`Page 4 (217 - 220)
`Page 219
`1 exception of claims 51 through 57 of the '486
`2 patent?
`A. No. Everything's in my declaration.
`Q. Okay. And are all the reasons in support
`4
`5 of these opinions included in your declaration?
`A. Yes.
`Q. Now, it's your opinion that a person of
`7
`8 ordinary skill in the art would have found it
`9 obvious to modify Steenfeldt-Jensen's fifth
`10 embodiment to swap the threaded circular opening of
`11 a component called member 40 with a slotted or
`12 non-circular opening of a component called driver
`tube 85; is that fair?
`13
`A. Where are you reading from?
`Q. Nowhere in particular, but it's -- I
`15
`16 believe that's your opinion; isn't that correct?
`A. Can you repeat that question?
`17
`Q. It's your opinion that a person of
`18
`19 ordinary skill in the art would have found it
`20 obvious to modify Steenfeldt-Jensen's fifth
`21 embodiment to swap threaded circular opening of a
`22 component called member 40 with a slotted or
`23 non-circular opening of a component called driver
`tube 85; is that correct?
`24
`MR. TORCZON: Objection, form.
`
`3
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`6
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`14
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`25
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`6
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`9
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`1 claim construction, the overview of the
`2 Steenfeldt-Jensen on page 71 of my declaration.
`3 And then page 155 and pretty close to the end of
`the declaration, or at least to page 422 -- or,
`4
`5 actually, it goes all the way -- yeah, pretty much
`to the end.
`Q. So for your opinion that, for example, the
`'069 patent is obvious over --
`MR. ANSLEY: I'm sorry.
`Q. For your opinions that the challenged
`10
`11 claims of the '069 patent are obvious over
`12 Steenfeldt-Jensen, you believe that the section
`13 beginning on page 347 includes opinions in that
`regard?
`14
`A. No. That would just be the '844. I
`thought you meant where I applied Steenfeldt-Jensen
`to my analysis.
`MR. ANSLEY: Okay. Maybe my question
`18
`19 wasn't so clear. Let me try again.
`Q. So on page 155, at the very top there,
`20
`21 under subheading B., you identify for the 11 ['069]
`22 Ground 2: Claim 1 is obvious over
`23 Steenfeldt-Jensen; ['044-B] Ground 1: Claims 11,
`24 14-15, and 18-19 are obvious over
`25 Steenfeldt-Jensen. 11
`
`15
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`16
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`17
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`8
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`Page 218
`And for the ['486-A2] Ground 1: Claims
`1
`2 1-6, 12-18, 20, 23, 27-30, 32-33, 36, 38-40 are
`3 obvious over Steenfeldt-Jensen."
`And my question is, are the opinions that
`4
`5 you have in support of these grounds, are they
`6 accurately described in this section which includes
`7 paragraphs 258 through 3387
`A. The declaration speaks for itself. But
`that would be the section for that particular
`9
`10 analysis, which would include the claim
`11 constructions and the overview on page 71.
`Q. And are all the opinions you have in
`12
`13 support of these grounds included in this
`14 subsection B., the claim construction section, and
`in the overview on page 717
`15
`A. I made references to different sections of
`16
`1 7 my declaration, so I'm not sure if that has all of
`it in that one section. I don't want to narrow it
`18
`to one section in the declaration. So the
`19
`2 o declaration stands on its own, but that's the basic
`21 area where I make my analysis.
`Q. Do you have any opinions outside of this
`22
`23 declaration that Steenfeldt-Jensen alone renders
`24 obvious the challenged claims of the '069 patent,
`the '044 patent and the '486 patent, with the
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`Page 220
`A. It's not to swap. I don't know if you
`said swap the entire component. It's not to swap
`the entire component. It's to swap where the
`threads are located within 40 and to locate them in
`4
`5 85, and then the slot in 85 to be put into 40 of
`6 Steenfeldt-Jensen, which is Exhibit 1014.
`And I'm looking at Figure 17.
`Q. Okay. I see, yeah.
`And that is the extent of your proposed
`9
`10 modification; is that correct?
`A. That's correct.
`11
`Q. Are there any benefits from making this
`12
`13 proposed change?
`A. One of the benefits would be the
`14
`lengthening of the threads would allow you to do
`that in the driver 85 of Figure 17 of Exhibit 1014.
`If there were issues with force or additional
`1 7
`18 stress on the threads in item 40 of Figure 17, then
`19 you could move those to 85, and one skilled in the
`2 o art would be motivated to do so.
`Q. Are there any other benefits?
`21
`A. If the loads were such that it was
`22
`23 creating a frictional issue, and it allowed you to
`24 choose a different material for the driver, that
`2 5 could be utilized in a longer part than that same
`
`15
`
`16
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2164.004
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Portsmouth, NH
`Page 221
`1 material in a shorter part, then there might be
`some frictional benefits from doing that.
`I believe the patent talks about it being
`3
`4 pretty much an equal tradeoff in many places, that
`it could be in either part.
`Q. Any other benefit?
`A. It could allow you to make item 40 be an
`integral part of the housing and eliminate the use
`8
`9 of an unwinder tool to mold the housing, so it
`10 would make the housing easier to manufacture and
`11 eliminate a component.
`Q. Any other benefits?
`A. Not that I can think of.
`I think the patent clearly says it could
`14
`15 be either way. You could make some of those
`16 arguments going in the other direction. If the
`1 7 material and the threads work better together in a
`18 shorter distance with a different material in 40
`than in 85, a person of skill in the art would
`19
`2 o choose either direction as the molding and
`21 manufacturing and function needs were satisfied.
`Q. What analysis did you perform to
`22
`22
`23 understand whether there might be issues with force 23
`24 or stress on the threads in member 40 as depicted
`24
`2 5 and described in the fifth embodiment of
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`2
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`1 correct?
`MR. TORCZON: Objection, form.
`A. I didn't perform an analysis on -- I don't
`3
`4 have the parts that embody this patent.
`One skilled in the art just knows that
`that's a high stress area. So if there was a
`requirement to move those threads, the patent
`7
`8 clearly says that you can move them if required.
`Q. And the patent doesn't say or indicate
`9
`that there is high stress on the threads in member
`10
`11 40; is that right?
`A. I don't think it says that there's high
`stress on the threads, but to a person of skill in
`the art, that's the highest force area. Even to a
`layman, I think that would be well understood, that
`15
`16 you're pushing on the medication against the
`stopper, that you're going to have significant
`forces there, that's where your highest force is.
`18
`19 And then you're trying to reduce that down on the
`2 o button end. So that's pretty well understood that
`that's the high force area.
`Q. How is that force reacted?
`A. I don't understand your question.
`Q. How is the force reacted from the
`25 cartridge piston to the piston rod reacted
`
`Karl R. Leinsing, MSME, PE (Vol. II)
`
`6/4/2019
`Page 5 (221 - 224)
`Page 223
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`Page 224
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`1 Steenfeldt-Jensen?
`A So in doing these analyses, you don't test
`2
`3 extrinsic evidence, you look at the intrinsic
`4 evidence of the prior art from a position of a
`5 person of skill in the art at the time frame of the
`6 asserted patents.
`So one skilled in the art knows from
`7
`8 developing these kind of devices that the highest
`force you have is between the piston rod and the
`9
`10 cartridge in pushing out the medication, so if
`there's a concern with that, then you have an
`11
`12 option to change it.
`And then without doing any
`13
`14 experimentation, the patent discusses the option of
`15 moving the threads from the item 40 to item 85 on
`16 Figure 17 of Exhibit 1014 in at least three places.
`One, for example, is in column 3, lines 41
`17
`to 47. So the inventor is clearly showing that
`this is an option to consider in that it would be
`19
`20 simply a design choice to go back and forth,
`21 depending on how manufacturing design requirements
`22 necessitated a change.
`Q. So you performed no analysis to understand
`23
`24 whether there would be force or stress on threads
`25 of member 40 that would be unacceptable; is that
`
`18
`
`throughout the rest of the pen injector as
`1
`2 disclosed and described in the fifth embodiment of
`3 Steenfeldt-Jensen?
`A. The reaction force would be an axial force
`4
`5 pushing against the piston rod, which would then
`6 exert forces through the threads to item 40 or to
`item 85, depending on where you choose to put the
`threads.
`Q. And if you putthe threads on item 85, is
`there a further chain in the reactive force path?
`A. Can you repeat that question?
`Q. Yeah. So if you then put the threads in
`item 85 -- you mentioned in your last answer that
`the reactive forces would be borne there -- is
`there further to that reactive force chain, after
`the threads in driver tube 85?
`MR. TORCZON: Objection, form.
`A. I don't understand your question.
`Q. So after forces from the piston rod are
`20 exerted on item 85, if threaded, are there
`21 additional forces in the force chain after that?
`22
`A. There would be some reaction-type forces,
`rotational forces. So 40 would have to counteract
`the torque. It would have the non-circular opening
`in 40, so there would be some antitorque forces
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`24
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2164.005
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing, MSME, PE (Vol. II)
`
`6/4/2019
`Page 6 (225 - 228)
`Page 227
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`Portsmouth, NH
`Page 225
`that would be applied to 40 as you're turning 85.
`Q. Under your proposed modification, during
`2
`3 dose injection, does driver tube 85 exert a force
`4 on the housing?
`A. It wouldn't directly. It would only do
`that through other parts.
`Q. And what other parts would it do that
`through?
`A. So you have it from two directions because
`forces are equal and opposite. So you first have
`the force of the human holding the housing and
`11
`12 pushing on the button, so you're counteracting
`forces all the way through the components in that
`13
`14 direction.
`And then you counteract against the
`15
`16 housing. If 85 is threaded through insert 40, it
`1 7 would be fixed to the housing. So there would be
`18 some forces on 40, and then hence on the housing.
`Q. Under your proposed modification, during
`19
`2 o the dose injection phase, doesn't the piston rod 6
`21 exert a force on the driver tube that has a
`22 proximal vector component?
`MR. TORCZON: Objection, form.
`A. I don't understand your question. What's
`24
`25 a "proximal vector"?
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`1
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`5
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`6
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`7
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`8
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`9
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`10
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`23
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`1 driver tube 85 is rotating as well; is that
`2 correct?
`A. Can you repeat that?
`Q. Under your proposed modification where the
`threads are in driver tube 85, is driver tube 85
`rotating during dose injection?
`A. Yes.
`Q. I want to ask a question about another
`8
`9 benefit you mentioned to making this modification.
`1 o You mentioned that if the loads create a frictional
`issue, you might be able to use a different plastic
`11
`in a larger component such as driver 85; is that
`right?
`MR. TORCZON: Objection, form.
`A. It would give you the option to have
`15
`16 different plastics in each of the different
`1 7 components and come up with a lowest friction
`18 alternative.
`Q. And what analysis did you perform to
`19
`2 o evaluate this benefit?
`A. I know from past experience when you're
`21
`22 designing something, from pen injectors to gear
`trains, that you're trying to get gears or what we
`2 3
`24 call worm wheel type devices to slide freely
`2 5 amongst each other, you want to distribute those
`
`12
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`13
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`Page 226
`
`Page 228
`Q. Sorry. A vector in the proximal
`loads and have options to be able to try different
`1
`1
`2 direction.
`2 bearing surfaces or sliding surfaces between the
`3 parts.
`A. So can you repeat your question?
`Q. Did you do any finite element analysis to
`Q. Yeah. So under your proposed
`4
`4
`5 understand what the frictional issues you might
`5 modification, during the dose injection phase, does
`6 experience in the fifth embodiment of
`the piston rod 6 exert a force on the driver tube
`6
`7 Steenfeldt-Jensen's pen injector?
`7 85 that has a vector in the proximal direction?
`A. No. I don't have the commercial
`A. The piston rod will have an axial
`8
`8
`9 embodiment of this device. But one of skill in the
`9 component going in both directions, the proximal
`10 art doesn't have to. I mean, the patent talks
`10 and the distal. The distal pushes the medication
`11 about making this option at least three times.
`11 out of the cartridge and the proximal is the
`Q. And you didn't perform any other
`reaction force of that. So I believe, yes.
`12
`Q. And are there forces in your proposed
`13 mathematical analysis or modeling to understand
`13
`this alleged benefit; is that correct?
`14 modification exerted between the ring-shaped wall
`14
`A. No. Because it sounds like the inventor
`15 46 and the driver tube 85 during dose injection?
`15
`16 has already considered both options.
`A. I just found 46. Can you repeat that
`16
`Q. Do you think that the fifth embodiment as
`1 7 question?
`1 7
`Q. Are there forces in your proposed
`18 described and depicted in Steenfeldt-Jensen would
`18
`19 modification exerted between the ring-shaped wall 19 work?
`2 o 46 and the driver tube 85 during dose injection?
`A. Yes, absolutely. I think it's actually a
`20
`A. With the threads in 85?
`21 commercial embodiment now.
`21
`Q. Would you be surprised to learn thatthe
`Q. Yes.
`22
`A. Yes, there would be.
`2 3 modification you proposed to Steenfeldt-Jensen's
`Q. And during dose injection, under your
`fifth embodiment would result in a pen with a
`24
`24
`25 proposed modifications of the threads being in 85,
`25 higher injection force?
`
`3
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`12
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`22
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`2 3
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2164.006
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing, MSME, PE (Vol. II)
`
`Portsmouth, NH
`Page 229
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`A Are you reading that from somewhere?
`Q. Yeah, some notes. But nothing from
`2
`3 anything that I believe you've cited, if that
`4 helps.
`A It's not a material I've used before. I'm
`5
`6 not that familiar with it.
`Q. How about --
`7
`A Maybe that's why they had high friction.
`Q. How about PBT or polybutylene --
`A Terephthalate.
`Q. So you have heard of that one?
`A Yes.
`Q. Okay. And are you aware of the frictional
`coefficient for PBT?
`MR. TORCZON: Objection, scope.
`A I'm somewhat familiar. I don't know the
`1 7 coefficient of friction of that material offhand.
`18 But friction with plastics has a lot to do with the
`19 geometry as well, how it's molded, where you put
`2 o part lines, that can cause issues between the
`21 parts. But it's not the best or lowest coefficient
`22 of friction. There's other materials such as
`23 Teflons or Delrin, but it has decent low friction
`24 properties.
`Q. If you had a physical embodiment of
`
`1
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`7
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`10
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`11
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`12
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`25
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`A I don't know where you're getting that
`information, but I would be surprised, but I
`2
`3 wouldn't be surprised if, for example, they were
`locked into certain materials for the piston rod
`4
`5 because of economies of scale or other factors.
`6 And if they were trying to make that change after
`the design was complete, then they might have been
`locked into certain materials and didn't have that
`8
`9 option that I was mentioning to you earlier.
`Q. Well --
`MR. ANSLEY: Strike that.
`Q. And all else being equal in the pen
`injector in Steenfeldt-Jensen's fifth embodiment
`13
`13
`14 and the proposed modification you make, do you know 14
`15 why the modification would result in a pen with a
`15
`16 higher injection force?
`MR. TORCZON: Objection, form.
`17
`A I'd have to know all the materials and
`18
`19 conditions on which they made that swap.
`What's more important for my analysis is
`2 o
`21 can the threads actually be there, and the inventor
`22 clearly says that that's an option. And hence,
`this invention is taught or known. It gives the
`2 3
`24 person of skill in the art to try both.
`It's another embodiment, that's what the
`
`16
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`25
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`Page 232
`Page 230
`inventor's trying to do here. And then it's up to
`1 Steenfeldt-Jensen's fifth embodiment and a physical
`the person of skill in the art to then tweak some
`2 embodiment of the same pen injector but with the
`2
`3 materials, shift the threads to one part or the
`3 modification you propose, and that second pen
`4 other, and determine what is best for their
`injector had a higher injection force, would that
`impact your opinions that you've rendered in your
`5 particular design to meet their requirements.
`5
`Q. Assume you don't change the materials that
`6 declaration?
`6
`A No. And it's not a modification that I
`7 you've already selected and optimized for the fifth
`7
`8 embodiment as shown in Steenfeldt-Jensen, and then
`8 proposed. Steenfeldt-Jensen himself, if that is a
`9 man, is proposed by him, not me, in his own patent,
`9 you apply the proposed change of putting the
`10 Exhibit 1014, the '004 patent.
`threads from member 40 in the driver tube 85 and
`10
`11 putting the slotted opening of driver tube 85 in
`Q. And if it turned out that that second pen
`11
`injector that I described were inoperable, that is,
`12 number 40, do you know why that modification would 12
`result in a pen injector having a higher injection
`13 you couldn't inject a dose with it, would that
`force?
`impact your opinions?
`A No. Because the purpose of this analysis
`MR. TORCZON: Objection, form.
`A I'd have to look at the parts, because it
`is to show whether or not a particular invention
`16
`16
`1 7 doesn't seem clear just from what you're saying why
`1 7 existed in the prior art and whether or not that
`there would be a higher injection force,
`18 claim is valid. It has nothing to do with a
`18
`19 particularly since there is other prior art where
`19 particular embodiment that some engineer made that
`there isn't threads in an item similar to 40 in the
`2 o was of that embodiment and they had issues with it.
`2 o
`21 prior art that don't have such an issue or at least
`I've been an engineer for decades, and it
`21
`22 don't claim to have such an issue.
`22 wouldn't be the first time I looked at something
`Q. Are you aware of a material called POM or
`2 3 and there was another reason why something didn't
`23
`24 polyoxymethylene?
`24 work right, either it was the way they molded it,
`MR. TORCZON: Objection, scope.
`they put the tolerances too close to each other,
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`1
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`14
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`25
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2164.007
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing, MSME, PE (Vol. II)
`
`4
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`6/4/2019
`Page 8 (233 - 236)
`Portsmouth, NH
`Page 235
`Page 233
`1 gearing so that the injection button has a larger
`they didn't form the threads right. It doesn't
`1
`2 stroke than the piston, right?
`2 mean that the invention would be inaccurate or
`A. That's correct.
`3 would not invalidate one of the Sanofi patents.
`Q. Okay. And then this makes the injection
`Q. Put Steenfeldt-Jensen aside for now.
`4
`5 button movement easier to sense because the button
`Tum to the section beginning with
`5
`6 paragraph 339.
`6 has to move a longer distance to dispense the same
`7 amount of medication, right?
`A. Paragraph 309?
`7
`Q. 339. So it's on page 202 of your
`A. That's correct.
`8
`Q. And, again, what's being described here is
`9 declaration. Let me know when you're there.
`9
`A. Okay.
`1 o the process of -- during the process of injecting,
`10
`Q. In this section, which begins at paragraph
`11 correct?
`11
`12 339 and continues through paragraph 445, you offer 12
`A. Correct.
`Q. You can put that aside.
`13 opinions that M0ller in combination with
`13
`Let's go to paragraph 492 of your
`14 Steenfeldt-Jensen render obvious the challenged
`14
`15 claims of the '069 patent, the '044 patent, the
`15 declaration. What did I say? I'm sorry. 792.
`'486 patent, with the exception of claims 51
`Now, in this section that begins on
`16
`16
`through 57, correct?
`17 paragraph 792, page 439 of your declaration and
`A. I believe that's correct.
`18 continues through paragraph 855, you provide your
`Q. All right. And all your opinions in
`19 opinions about whether M0ller combined with
`19
`2 o support of these grounds are contained in
`20 Steenfeldt-Jensen renders obvious each of the
`21 paragraphs 339 through 445?
`21 challenged claims of the '008 patent; is that
`22 correct?
`A. That and other sections of my declaration.
`22
`Q. So all the opinions are included in
`A. Yes. Including some of the other sections
`2 3
`24 of my declaration.
`support of these grounds in your declaration; is
`Q. And so this section and perhaps some other
`that fair?
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`Page 236
`sections of your declaration, as you mentioned,
`A. That's fair.
`1
`2 accurately reflect your opinions that the
`Q. And all the reasons in support of those
`2
`3 combination ofM0ller and Steenfeldt-Jensen renders
`3 opinions are included in this declaration; is that
`4 obvious the challenged claims of the '008 patent?
`fair?
`4
`A. Yes, in addition to what I hope explain to
`A. Yes, in addition to what we discuss today.
`5
`6 you today.
`Q. Could you pull up the M0ller reference,
`6
`Q. Okay. And this section of the declaration
`7 which is Exhibit 1015. I'll direct your attention
`7
`8 and perhaps some other sections of the declaration
`to the first page of text that has a 1 at the top.
`include all of your reasons in support of these
`It begins with paragraph 1 and has a number of
`9
`9
`10 opinions; is that correct?
`10 paragraphs following.
`A. That's correct.
`Okay. Look at paragraph 5. Take a moment 11
`11
`Q. Let's go to Burroughs real quick, which is
`just to review it.
`Let me know when you're
`12
`13 Exhibit 1013.
`finished.
`You testified yesterday that you've read
`A. Okay.
`14
`15 Burroughs a number of times, correct?
`Q. All right. So M0ller discloses that small
`15
`A. Yes.
`16 movements of the pen injector buttons were
`16
`Q. What do you think is inventive about the
`1 7 difficult to feel; is that right?
`17
`18 pen injector described in Burroughs?
`A. That's right.
`18
`MR. TORCZON: Objection, scope.
`Q. Okay. And so this is referring to when a
`19
`19
`A. I didn't do an analysis on Burroughs to
`2 0 user is attempting to feel whether the injection
`20
`21 determine whether Burroughs is inventive or not.
`21 button has been pushed forward when injecting,
`Q. Based on your familiarity with Burroughs
`right?
`22
`22
`2 3 and your familiarity with the pen injector art as
`A. That's correct.
`24 of 2003, does anything come to mind as being
`Q. Okay. And if you look at paragraph 6,
`24
`25 M0ller says that a solution to this is to provide a
`inventive in Burroughs?
`
`25
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2164.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing, MSME, PE (Vol. II)
`
`Portsmouth, NH
`Page 237
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`MR. TORCZON: Same objection.
`A. I'd have to do an analysis to see if
`there's any prior art, but maybe the little -- the
`ratchet teeth that work on the piston rod.
`Q. Which ratchetteeth are these?
`A. I think they're labeled as 182. Oh,
`they're called anti-backup tangs 182, described on
`7
`8 column 11 of Exhibit 1013, lines 52 to 56. Again,
`I haven't done an analysis to determine if that's
`inventive or not, but that's one thing I don't see
`11 very often.
`And then the other possible, although not
`12
`13 sure without a full analysis, would be just the
`type of button that's used and how the pen allows
`14
`15 some initial free play in there; whether there's a
`16 benefit or not to that, I didn't do an analysis on
`that, or whether or not there's any prior art.
`17
`Q. When you say the "button," which component
`19 are you referring to?
`A. 32.
`20
`Q. Okay. Anything else that you would
`22 consider inventive about the pen injector
`23 disclosed, depicted, and described in Burroughs?
`MR. TORCZON: Objection, scope.
`24
`A. Again, I'd have to go through and look at
`
`18
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`6/4/2019
`Page 9 (237 - 240)
`Page 239
`But is there anything inventive that you
`see otherwise in Steenfeldt-Jensen?
`MR. TORCZON: Same objections.
`Sutton, we're right at an hour now. Are
`4
`5 you coming to a breaking point?
`MR. ANSLEY: Can we do five, 10 more
`6
`7 minutes and I think we'll be at a really good
`8 breaking point.
`MR. TORCZON: Is that okay, with you,
`Karl?
`THE WITNESS: Yeah.
`A. Again, I'd have to, I think, look at these
`claims closely and what the prior art is to see if
`there's anything that's really inventive. But I
`think item 85, where the anti-turning features is
`incorporated into that part and works with the
`housing may be. The same thing with the clutch
`that's incorporated up into the item 82. But I'm
`not -- again, I need to do an analysis to really
`see what was really inventive and what was prior to
`this.
`Q. Okay. How about M0ller, so Exhibit 1015,
`is there anything in M0ller that you believe to be
`inventive?
`MR. TORCZON: Same objections.
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`A. Again, I'd need to read through the claims
`it against the prior art, look at their claims, see
`1
`1
`2 and what the prior art is to see what was truly
`2 whether there was anything that was really
`inventive. But