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`
` UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`--------------------------------
`SANOFI-AVENTIS U.S. LLC, CIVIL ACTION NUMBER:
`SANOFI-AVENTIS DEUTSCHLAND
`
`GMBH, and SANOFI WINTHROP
` 2:17-cv-09105-SRC-CLW
`INDUSTRIE,
`
` Plaintiffs, Trial Volume 2
`vs.
`
`MYLAN GMBH, BIOCON LTD.,
`BIOCON RESEARCH LTD.,
`BIOCON SDN.BHD, and
`BIOCON S.A.,
`
` Defendants.
`________________________________
`MARTIN LUTHER KING BUILDING & U.S. COURTHOUSE
`50 Walnut Street
`Newark, New Jersey 07101
`December 3, 2019
`Commencing at 10:05 a.m.
` B E F O R E:
`THE HONORABLE STANLEY R. CHESLER
`UNITED STATES DISTRICT JUDGE
`A P P E A R A N C E S:
`
`WALSH PIZZI O'REILLY FALANGA LLP
`BY: LIZA M. WALSH, ESQUIRE
` CHRISTINE I. GANNON, ESQUIRE
` KATELYN O'REILLY, ESQUIRE
` WILLIAM T. WALSH, JR., ESQUIRE
`One Riverfront Plaza, Suite 600
`Newark, New Jersey 07102
`For the Plaintiffs
`
`Rhéa C. Villanti, Official Court Reporter
`RheaVillanti@Yahoo.com
` (732)895-3403
`
`
`Proceedings recorded by mechanical stenography; transcript
`produced by computer-aided transcription.
`
`
`
`
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.001
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

` 183
`
`(Continuing)
` P P E A R A N C E S:
`
`WEIL, GOTSHAL & MANGES LLP
`BY: ELIZABETH S. WEISWASSER, ESQUIRE
` ANISH R. DESAI, ESQUIRE
` ANNA DWYER, ESQUIRE
` ANDREW GESIOR, ESQUIRE
`767 Fifth Avenue
`New York, New York 10153
`For the Plaintiffs
`
`and
`
`WEIL, GOTSHAL & MANGES LLP
`BY: ROBERT T. VLASIS III, ESQUIRE
` W. SUTTON ANSLEY, ESQUIRE
` MATTHEW SIEGER, ESQUIRE
` SUDIP KUNDU, ESQUIRE
` NATALIE KENNEDY, ESQUIRE
` ADAM BANKS, ESQUIRE
`2001 M Street NW, Suite 600
`Washington, DC 20036
`For the Plaintiffs
`
`SAIBER LLC
`BY: ARNOLD B. CALMANN, ESQUIRE
` JEFFREY SOOS, ESQUIRE
` KATHERINE A. ESCANLAR, ESQUIRE
`One Gateway Center
`Tenth Floor, Suite 1000
`Newark, New Jersey 07102
`For the Defendants
`
` and
`
`WILSON SONSINI GOODRICH & ROSATI P.C.
`BY: DOUGLAS H. CARSTEN, ESQUIRE
` ELHAM FIROUZI STEINER, ESQUIRE
` ARTHUR P. DYKHUIS, ESQUIRE
` ALINA L. LITOSHYK, ESQUIRE
` JAMES P.H. STEPHENS, ESQUIRE
` MICHAEL TAYLOR DIMLER, ESQUIRE
`12235 El Camino Real
`San Diego, California 92130
`For the Defendants
`
`
`
` A
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` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.002
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`
`(Continuing)
`A P P E A R A N C E S:
`
`WILSON SONSINI GOODRICH & ROSATI P.C.
`BY: NICOLE STAFFORD, ESQUIRE
`900 South Capital of Texas Highway
`Las Cimas IV, 5th Floor
`Austin, Texas 78746
`For the Defendants
`
`ALSO PRESENT:
`IN-HOUSE COUNSEL WITH SANOFI:
`Stephanie Donahue, Esquire
`
`IN-HOUSE COUNSEL WITH MYLAN:
`Thomas Jenkins, Esquire
`Steve Flynn, Esquire
`Matthew Greiner, Esquire
`
`
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.003
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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` Cross Redirect Recross
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`269
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` 328
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`263
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`353
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`
`INDEX
`Witnesses
` Direct
`FOR THE PLAINTIFF
`
`HENRY GEORGE GRABOWSKI
`Voir Dire by Mr. Walsh
`
`Mr. Walsh
`
`Ms. Steiner
`Mr. Walsh
`WAYNE TALTON (Videotape)
`RAJ VANGA (Videotape)
`CHRYS KOKINO (Videotape)
`
`FOR THE DEFENSE
`
`MICHAEL VINCENT QUINN
`Voir Dire by Ms. Steiner 222
`
`Ms. Steiner
`226
`Mr. Desai
`KARL LEINSING
`Voir dire by Mr. Carsten 274
`Mr. Carsten
` 277
`Mr. Desai
`
`Mr. Carsten
`
`DAVID PLUMPTRE (Videotape) 361
`ROBERT PERKINS (Videotape) 362
`ANDREAS BODE (Videotape) 362
`ANGELA MOSKOW (Videotape) 362
`
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.004
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`the market, the way to do it was to get firsthand evidence of
`it.
`
` 273
`
`MR. DESAI: That's right.
`THE COURT: For me, including a deposition if
`necessary. Objection sustained. Let's go.
`(Whereupon sidebar ended.)
`(In open court.)
`THE COURT: Back on the record.
`While you folks are getting organized, Mr. Soos, come
`here. This is on a totally unrelated matter.
`(Discussion off the record between the Court and
`Mr. Soos.)
`THE DEPUTY CLERK: Counsel, are we ready to start?
`
`1:18.
`
`MR. CARSTEN: May I proceed?
`THE COURT: You may.
`MR. CARSTEN: Thank you, Your Honor. Defendants call
`their next witness, Mr. Karl Leinsing.
`THE DEPUTY CLERK: Please place your left hand on the
`Bible, raise your right.
`KARL LEINSING, DEFENSE WITNESS,
`having been duly sworn, testifies as follows:
`THE DEPUTY CLERK: State your full name for the
`
`record.
`
`THE WITNESS: Karl Robert Leinsing.
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.005
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`Leinsing-Voir Dire-Carsten
`THE DEPUTY CLERK: Thank you.
`THE COURT: Proceed.
`(VOIR DIRE EXAMINATION)
`
` 274
`
`BY MR. CARSTEN:
`Q.
`Good afternoon, Mr. Leinsing.
`A.
`Good afternoon.
`Q.
`I put up in front of you a binder and a number of Ziploc
`bags identified as DDX-101, 102, 107, and 108. DDX-103 is
`still up there from the last witness. If we need any of that,
`we can turn to that.
`I've also provided a copy to opposing counsel. I
`just provided copies of 101 and 102 to opposing counsel.
`THE COURT: I don't get any this time?
`MR. CARSTEN: You do, Your Honor.
`BY MR. CARSTEN:
`Q.
`Mr. Leinsing, would you please introduce yourself to the
`Court.
`A.
`Yes. My name is Karl Leinsing, and I'm missing the bag
`that has the piston rod of the SoloStar®.
`Q.
`Well, we can use 103 for that if we need to. That's the
`piston rod, right?
`A.
`Yeah. I just can't take it out.
`Q.
`Are you an engineer?
`A.
`Yes.
`Q.
`And would you please turn in your binder, the white binder
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.006
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`Leinsing-Voir Dire-Carsten
`in front of you, to DTX-2262.
`A.
`Okay.
`Q.
`What is that?
`A.
`This my CV.
`Q.
`Is it true and accurate?
`A.
`Yes.
`Q.
`Have you prepared slides to assist you in presenting your
`testimony today?
`A.
`Yes, I have.
`MR. CARSTEN: May we turn to DDX-302, please.
`BY MR. CARSTEN:
`Would you please describe your educational
`background.
`A.
`Yes. I have an undergraduate degree in mechanical
`engineering and a graduate degree in mechanical engineering.
`Q.
`Are you a professional engineer, do you have a license?
`A.
`Yes. I'm licensed in the State of New Hampshire.
`Q.
`Where do you work?
`A.
`I work for ATech Designs, Incorporated.
`Q.
`What's your title?
`A.
`I'm the president of the company.
`Q.
`And tell me generally about the kind of work you do as it
`pertains to medical devices.
`A.
`We do all types of different devices from ID disposables,
`pen injectors, auto injectors, worked on some cardiovascular
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.007
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`devices, insulin pumps.
`Q.
`Do you have any experience directly with pen injectors?
`A.
`Yes.
`Q.
`Would you describe the context in which you first started
`work on pen injectors.
`A.
`Sure. The first work I did was in the mid-'90s when I
`worked for Ivac. It was a subsidiary of Eli Lilly, and I
`worked on the development of a dual-acting pen injector for Eli
`Lilly.
`Q.
`When was that?
`A.
`In the mid-'90s.
`Q.
`And you said "dual-acting." What does that mean?
`A.
`It means it's a pen that actually has two cartridges in
`it. It has the slow-acting insulin and the long-acting
`insulin, so it has two cartridges.
`Q.
`Do you have any patents from your work?
`A.
`Yes, I have 34 patents all related to medical devices.
`Q.
`Have you received any awards for your work?
`A.
`I've received many awards. I have about five design
`awards. One of them's shown here on this slide. I was the
`first designer received from medical device and manufacturing
`conferences and expo, and I also -- one of my devices is on the
`cover of Life Magazine.
`Q.
`What was that for?
`A.
`That was for the needle-free valve. It's the valve that's
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.008
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`shown in the lower left part of the magazine. That was used to
`help save this premature baby.
`Q.
`In terms of your design work in medical devices, did you
`start at the beginning from conception, and how far did you
`take that in connection with your work on medical devices
`throughout your career?
`A.
`I'm involved all the way from conception through
`prototyping, manufacturing, marketing, and sales and, training
`of surgeons or nurses if it's required.
`MR. CARSTEN: Your Honor, defense offers Mr. Leinsing
`as an expert in mechanical engineering, mechanisms for medical
`systems, full life cycle product development of medical devices
`from conception to manufacturing, drug and delivery medical
`devices such as auto injectors, pen injectors, and pumps.
`THE COURT: Any objection?
`MR. DESAI: No objection, Your Honor.
`THE COURT: So deemed.
`(DIRECT EXAMINATION)
`
`BY MR. CARSTEN:
`Q.
`Mr. Leinsing, will you tell us what you were asked to do
`in this case?
`A.
`I was asked to review several patents, namely one of them,
`the '844 patent, review its specification, its figures,
`including its figures, the claims, and the file history, and
`determine if there was any prior art and if the claims were
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.009
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`Leinsing-Direct-Carsten
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`
`invalid or not.
`Q.
`Now, in connection with that work, did you -- or were you
`instructed to apply any particular filter in terms of the way
`you evaluate the scope of those materials?
`A.
`I was to look at it from a person of skill in the art
`within the timeframe of the patent, which was 2003.
`Q.
`Did you come up with criteria as to what would be a person
`of ordinary skill in the art at that time?
`A.
`Yes, I did.
`Q.
`What's being shown on this slide?
`A.
`So this is a paragraph from my report that outlines what I
`felt a person of skill in the art would be in the relative
`timeframe.
`Q.
`And would you just summarize what the characteristics of a
`person of skill in the art would be.
`A.
`Yeah, basically, as I say here, it would be a person of
`educational practical experience, at least the equivalent of a
`bachelor's degree in mechanical engineering or related field.
`That person would also have approximately three years
`of practical experience with medical device design and
`manufacturing, or at least the understanding of the basic
`medical design and manufacturing as it pertains to pen
`injectors, gears, pistons, and those types of components.
`Q.
`Now, you're aware that Dr. Slocum is providing some
`rebuttal opinions to your opinions that you've expressed in
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.010
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`this case, and he has his own definition of what a POSA is,
`right?
`A.
`That's correct, yes.
`Q.
`Is it similar or different to yours?
`A.
`It's similar.
`Q.
`Let's put not too fine a point on it. Does it matter
`whether you apply your level or his level, would your opinions
`change?
`A.
`No, my opinions would be the same.
`Q.
`Let's turn to, if we could, the '844 patent.
`When was the '844 patent filed?
`It was filed in May of 2016.
`A.
`And does it claim priority back to earlier applications?
`Q.
`Yes, to the foreign priority application. That's
`A.
`March 3rd of 2003.
`Q.
`And did it finally get filed in the United States at any
`point?
`A.
`Yes, it did, in March of 2004.
`Q.
`What date did you apply in terms of your priority analysis
`here?
`A.
`I applied the March 3rd, 2003, date.
`Q.
`How many embodiments are disclosed in the '844 patent
`specification?
`A.
`One.
`Q.
`Did you prepare a slide with the asserted -- with the
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.011
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`claims that are asserted here at trial?
`A.
`Yes.
`Q.
`And what's being shown on the slide from JTX-3?
`A.
`So this is the claims that are currently being asserted in
`this case, namely claims 21, 22, 25, and 30, with the claim 25
`depending on claims 23 and 24.
`Q.
`Did you prepare any opinions relating to enablement or
`written description in this case?
`A.
`Yes.
`Q.
`And may I refer to those as Section 112 opinions?
`A.
`Yes, you may.
`Q.
`Let's talk about them. Generally speaking, what are your
`opinions regarding whether the asserted claims of the
`'844 patent -- sorry.
`Generally speaking, what are those opinions relating
`to the asserted claims of the '844 patent in terms of
`Section 112 opinions?
`A.
`That they were lacking written description and enablement.
`I found when I first read the '844 patent, and putting myself
`back as a person of skill in the art in 2003, it was very
`difficult to understand. There's a lot of components that
`weren't well described, particularly around the button area.
`And then there were claims that were written that just didn't
`agree with what the specification was talking about.
`Q.
`Before we go into the details there, did you come across
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.012
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`an animation to help describe how this embodiment disclosed in
`the '844 patent operates?
`A.
`Yes.
`Q.
`Where did that animation come from?
`A.
`Sanofi put together a nice animation that shows basically
`how the one embodiment operates.
`Q.
`I'd like to show this. Mr. MacQueen can pause the
`animation but would you please narrate it. And if you need it
`paused, just say so.
`A.
`So as we're going through the video here, we're going to
`show some of the different components that are shown. So here
`it's -- this is the cartridge that has the insulin, and then
`there's a container that goes on -- outside of it that holds it
`on to the pen injector. The blue is the piston rod, and in
`particular you can see the two different types of threads on
`this piston rod. This is what gives the mechanical advantage
`of the device.
`Then there's the drive sleeve in green, and then the
`purple part is the clutch. We show that wrapping around the
`proximal, the proximal end being the button end.
`And then we have another sleeve that's called a
`clicker here in gray. Then we have a dose dial sleeve. We've
`seen this discussed before. This rotates in and out of the
`housing. It has the numbers on it that you dial the dose with.
`Then there's a dose dial grip here in blue, and then
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.013
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`the push button is on the very end, and then a housing that
`goes around everything. So you kind of see how everything is
`sort of concentrically orientated inside this '844 embodiment.
`Q.
`What happens next here in DDX-305?
`A.
`So here we're going to show some of the operation, and you
`kind of can see even from Sanofi they didn't quite understand
`the patent because there's -- some aspects of how it works is
`missing even from the automation. But here it's basically
`setting a dose and then you're canceling it. There's no
`injection occurring as this goes in and out.
`Then when you push the button, you're releasing the
`clutch, and then you're forcing the driver to then engage the
`piston rod, which then pushes out -- the medication out of the
`cartridge.
`And here we kind of show a little bit of a
`transparent view of what's happening doing the same thing,
`dialing back, canceling, and then we dial back again.
`Q.
`There's been some testimony about releasably connected.
`Is that going to show here?
`A.
`Yes. So when you push the button, again, we're releasing
`the connection between the clutch and the dose dial sleeve so
`that it can inject.
`And you can see when we look closer, one of the
`things that was difficult with this patent to understand is
`when you push this button, what's actually pushing the clutch
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.014
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`down -- even in this animation it's not even shown, but what
`you can see is the clutch that is connected here. All these
`teeth, they're kind of yellow and orange and there you go.
`Then it just disconnected right there in order for it to
`inject.
`
`As soon as you release that button, it's then
`connected. So that's a releasably connected configuration.
`Q.
`Now, the '844 patent is not an only child, is it?
`A.
`Oh, no.
`Q.
`I showed a demonstrative in the opening, this is now
`DDX-306 of the '844 patent family tree. Would you describe for
`the Court what the important takeaways are from the '844 family
`tree?
`A.
`When you look at this, the embodiments or the
`specification of the '844 patent, they go way back. They go
`back to the 2003 timeframe, and as you can see, there's been a
`lot of different continue -- I think they call them CIPs or
`continuation in part or continuation patents, so there's a big
`family of patents that have come off that same specification.
`And then the one that I found that was really
`interesting was this '844 patent that we're now looking at
`today, it was rather timely with the Mylan device. And in
`particular when you looked at it, there was a specification
`that talked about internal -- internally threaded piston rod
`within the claims, but nowhere in all of these patent
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.015
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`applications or specifications does it ever talk about or ever
`show any kind of internally threaded piston rod.
`Q.
`As of 2016 was it knowledge that Mylan was going to be
`using a BD pen in an NDA for insulin glargine?
`A.
`Yes, I believe that became known to Sanofi and -- which I
`believe is what likely prompted this patent.
`Q.
`Now let's turn to a slide that summarizes your 112
`opinions. There are two elements in the first box, this is
`DDX-307, and one in the bottom. Let's talk about the ones on
`the top box if we could. That's a driving member comprising a
`third thread and a piston rod comprising either an internal or
`external fourth thread that engages the third thread.
`That bottom limitation, that's the internally
`threaded limitation you just talked about?
`A.
`Yes.
`Q.
`Let's turn to the -- to Figure 1 of the '844 patent,
`JTX-3. What does the patent teach about that piston rod?
`A.
`So if we look at Figure 1 of the '844 patent, all it
`teaches is a piston rod with two threads. One thread you can
`see is kind of angled to the left a little bit and it's a very
`finely pitched thread. The other thread that's up at the top
`you can see it angles in the opposite direction, so they're
`what we say opposing threads; so they turn in the opposite
`direction.
`And this is what gives the mechanical advantage
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.016
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`because the idea of all pen injectors is, you want the force at
`the button to be less than the force coming out. So they all
`have some type of mechanical advantage. And this is done with
`threads on the outside of the piston rod. Nowhere does it
`discuss any kind of mechanism with threads on the inside.
`MR. CARSTEN: Mr. MacQueen, can we go to JTX-3, claim
`21, please.
`BY MR. CARSTEN:
`Q.
`Now, there's a reference here about -- in claim 21 to a
`piston rod comprising either an internal or an external fourth
`thread that is engaged with the third thread.
`Do you see that?
`Yes, that's right here.
`A.
`And that refers to one of those two threads, right, that
`Q.
`you just talked about, the opposing threads?
`A.
`Yes, that's correct.
`Q.
`Now, in the specification did you find anything that
`taught about making those threads on the piston rod internal?
`A.
`There's nothing in the specification or the figures that
`mentions anything about internal threads on the piston rod.
`Q.
`So given this, how difficult would it have been at the
`time for a POSA to design and implement an internally threaded
`piston rod?
`A.
`It would have been very difficult. There -- would have
`required a lot of changes. And keeping in mind both myself and
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.017
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`Sanofi, experts on both sides, there's not a single piece of
`prior art of a pen injector with threads on the inside of a
`piston rod. It just doesn't exist. So it's not something
`that's inherent that a person of skill in the art would have
`understood in 2003, so it's not -- not only is it not
`inherently known, it was not taught in the patent in any way.
`Q.
`Now, Dr. Slocum at one of his depositions said essentially
`a person of ordinary skill in the art would be able to come up
`with an internally threaded piston rod and sketched out a
`document. Did you see that?
`A.
`Yes, I did.
`Q.
`Did you consider that in connection with your opinions in
`this case?
`A.
`Yes, I did.
`MR. CARSTEN: Let's take a look at DTX-2846 if we
`
`might.
`BY MR. CARSTEN:
`Q.
`What is that, Mr. Leinsing?
`A.
`This is the sketch that Dr. Slocum made during one of his
`depositions.
`Q.
`Do you agree that a person of ordinary skill in the art
`would be able to call to mind this structure based upon the
`disclosures of the '844 patent in the background of a person of
`skill in the art that the person brings with her?
`A.
`No. As you can see, even in his sketch that he's trying
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.018
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`to create, there's a lot of detail that's required. It creates
`a lot of structural problems. It creates a lot of
`manufacturing problems.
`It also doesn't agree with the specification of the
`patent. There's issues with the drive sleeve being between --
`in the patent there's discussions of the drive sleeve needing
`to be between the piston rod and the driver and -- I'm sorry,
`between the dose setting sleeve and the piston rod, and that
`just can't be possible with this configuration.
`Q.
`So what -- would you just walk us through, what is that --
`the thing that looks almost like a football field goal on the
`top, the blue thing?
`A.
`You're talking about this part here?
`Q.
`Above that. Right there. What is that?
`A.
`This is the part that's on the drive sleeve. This is
`where the actual -- the tracking nut goes on the drive sleeve.
`Q.
`And then moving to the right, what is that?
`A.
`On this end here?
`Q.
`Yes.
`A.
`This is where Dr. Slocum had this welding or bonding where
`he would put this, what he calls a stinger inside a piston rod.
`Q.
`And what is that stinger?
`A.
`It's basically a really tiny, I guess, threaded rod that
`would go inside the piston rod, and to do that it would have to
`be extremely small, which would then result in likely buckling
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.019
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`Leinsing-Direct-Carsten
`issues, which would then force the whole device to be changed
`and made much bigger in order to make that work. But then
`there's also other problems with the drive sleeve that just
`wouldn't work with the way he's described it here.
`Q.
`How big would that stinger be? Do you have something up
`there that you can show us what the scale we're talking about
`is?
`A.
`Q.
`A.
`
`Yeah. So -- let me see if I can take this apart here.
`Do you have DDX-103 in your hand?
`Yes.
`So I have DDX-103 in my hand, and I've taken the
`piston rod out of that bag. You can see here, this is the
`piston rod that's representative of what would be in the
`'844 patent, so you can see it's very small.
`What Dr. Slocum is proposing is to put something else
`inside this, which would be extremely small and likely buckle
`if you put any kind of load on that.
`Q.
`So what is that piston rod that you held in your hand,
`DDX-103? What element does that correspond to in DTX-2846?
`A.
`So that would be this piston rod here, so he's proposing
`to actually put a threaded hole inside this very small
`component that I have in my hand.
`Q.
`And what fits inside that hole?
`A.
`Well, I don't know that anything would fit inside the hole
`but he's proposing to put this stinger. I think maybe he
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.020
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`Leinsing-Direct-Carsten
`likely calls it a stinger because it's something very small and
`very pin-like.
`Q.
`Is there any suggestion in the text of the '844 patent to
`a person of skill in the art of this approach to the devices?
`A.
`No, there's nothing in the '844 patent that talks about or
`proposes this. It contradicts the specification in many ways,
`and it's not something that's ever been done in a pen injector.
`Q.
`In blue text there's a statement on how Dr. Slocum
`proposes to manufacture this drive sleeve with a stinger. What
`does that say?
`A.
`You're talking about this here?
`Q.
`Yes.
`A.
`Yeah, he just talks about bonding this. So this would --
`this proposed design would add an additional part. It adds an
`additional step of bonding or welding. You would have to make
`sure that this small threaded rod would be aligned with an
`outer sleeve. It would just add a lot of complexity. That
`would need to be worked out. It would take time to do that. A
`lot of experimentation to figure that out.
`Q.
`How would a person of ordinary skill in the art consider
`that suggestion? Would they consider it, oh, that's easy, I
`can do that?
`A.
`No, that would not be easy. I think when we look at the
`devices here, I don't think there's a single one we're looking
`at that has a welded feature like that. It would add a lot of
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.021
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`complication.
`Q.
`Is there any evidence in the specification that the
`inventors had possession of an internally threaded piston rod
`such as the stinger shown here?
`A.
`I don't believe they possessed such an invention.
`Q.
`Let's turn to further language in the claim. Can you
`explain your opinion -- how your opinion relates to the drive
`sleeve aspect of the claim, the drive sleeve located between
`the dose dial sleeve and the piston rod.
`A.
`Yes. So when we look at the claim it says "drive member,"
`and then when you look to the specification of what the member
`would be, the only thing that it could be is a sleeve. So the
`drive sleeve -- it talks about a drive sleeve being located
`between the dose dial sleeve and the piston rod.
`So you can't have that configuration with what
`Dr. Slocum is proposing. Then that would make the drive member
`in the middle so you're not going to be between now the piston
`rod and the dose dial sleeve. It would now be the piston rod
`between a drive rod and a dose setting sleeve. So it just
`doesn't -- the patent just simply does not teach this
`configuration.
`Q.
`How would a person of ordinary skill in the art consider
`this suggestion by Dr. Slocum? Is this an easy engineering
`task?
`A.
`No, it would take considerable time.
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.022
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`Would you say this is a different device altogether, or
`Q.
`how would you characterize it?
`A.
`Oh, it would be a different device altogether. I think
`this part alone would take about a year, at least, in
`experimentation to kind of work it all out and make it work,
`even if you could make it work reliably with something welded
`like that.
`Q.
`Could a person of ordinary skill in the art make an
`internally threaded piston rod with an externally threaded
`drive member as of the priority date without undue
`experimentation?
`A.
`No, they would not. They would have to do quite a bit of
`work to make that work.
`Q.
`Can you summarize your criticisms or concerns about
`Dr. Slocum's suggested stinger solution?
`A.
`So as I mentioned, it would create issues with the size of
`the device. The way these devices were all developed -- with
`pen injector-type devices, you start off usually with the
`piston rod as the smallest component in the concentrically
`arranged other components.
`So by putting a stinger in the middle now of that
`piston rod, you now make everything else bigger. So that would
`force the size of the device to have to be bigger while using
`all of the other components taught within the patent.
`So that would be problematic. As we've heard before,
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.023
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`we want these devices to be small, to be able to be held in
`your hand.
`Manufacturing concerns, as I mentioned, with welding
`or additional parts, keeping everything reliable; the
`structural concerns with that stinger being small and buckling;
`and it's just simply not taught in the patent and it's not
`routinely known.
`Both Dr. Slocum and myself didn't find a single piece
`of prior art that teaches an internally threaded piston rod in
`a pen injector.
`Q.
`Given these concerns, do you have an opinion as to whether
`a person of skill in the art would believe that the inventors
`as of the priority date had possession of an internally
`threaded piston rod and externally threaded driver?
`A.
`They did not possess that invention.
`Q.
`And based on the background of a person of skill in the
`art and the teachings of the '844 patent, could a person of
`skill in the art have actually made such a device without undue
`experimentation?
`A.
`No. It would have taken considerable experimentation.
`Q.
`Is there any doubt in your mind about that?
`A.
`No.
`Q.
`Let's turn to the second aspect, a piston rod holder
`configured to prevent the piston rod from rotating during dose
`setting. Let's take a look at the claim here. This is the
` United States District Court
` Newark, New Jersey
`
`Exhibit 2227.024
`Sanofi v. Mylan
`IPR2018-01676
`
`

`

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`Leinsing-Direct-Carsten
`claim 21 from -- an element of claim 21 from JTX-3 of the
`'844 patent at the top, right?
`A.
`Correct.
`Q.
`What does that say?
`A.
`So it's saying a piston rod holder that is rotatably fixed
`relative to the housing -- so meaning it's fixed to the outer
`housing of the pen injector -- and configured to prevent the
`piston rod from rotating during dose setting and permit the
`piston rod to traverse axially towards the

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