467
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`__________________________
`
`SANOFI-AVENTIS U.S. LLC,
`SANOFI-AVENTIS DEUTSCHLAND
`GMBH, and SANOFI WINTHROP
`INDUSTRIE,
`
`Plaintiffs,
`
`vs.
`
`
`
`MYLAN GMBH, BIOCON LTD.,
`BIOCON RESEARCH LTD.,
`BIOCON SDN, BHD., and
`BIOCON S.A.,
`
`Defendants.
`____________________________
`
`CIVIL ACTION NUMBER:
`
`2:17-cv-09105-SRC-CLW
`
`BENCH TRIAL
`
`VOL. 4, Pages 467 - 624
`
`Frank R. Lautenberg Post Office and Courthouse
`Two Federal Square
`Newark, New Jersey 07102
`Thursday, December 5, 2019
`Commencing at 1:10 p.m.
`
`B E F O R E:
`
`THE HONORABLE STANLEY R. CHESLER,
`UNITED STATES DISTRICT COURT 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
`and;
`
`
`
`/S/ Lisa A. Larsen, RPR, RMR, CRR, FCRR
`Lisalarsen25@gmail.com
`(630)338-5069
`
`Proceedings recorded by mechanical stenography.
`Transcript produced by computer-aided transcription.
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`__________________________
`
`SANOFI-AVENTIS U.S. LLC,
`SANOFI-AVENTIS DEUTSCHLAND
`GMBH, and SANOFI WINTHROP
`INDUSTRIE,
`
`Plaintiffs,
`
`vs.
`
`
`
`MYLAN GMBH, BIOCON LTD.,
`BIOCON RESEARCH LTD.,
`BIOCON SDN, BHD., and
`BIOCON S.A.,
`
`Defendants.
`____________________________
`
`CIVIL ACTION NUMBER:
`
`2:17-cv-09105-SRC-CLW
`
`BENCH TRIAL
`
`VOL. 4, Pages 467 - 624
`
`Frank R. Lautenberg Post Office and Courthouse
`Two Federal Square
`Newark, New Jersey 07102
`Thursday, December 5, 2019
`Commencing at 1:10 p.m.
`
`B E F O R E:
`
`THE HONORABLE STANLEY R. CHESLER,
`UNITED STATES DISTRICT COURT 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
`and;
`
`
`
`/S/ Lisa A. Larsen, RPR, RMR, CRR, FCRR
`Lisalarsen25@gmail.com
`(630)338-5069
`
`Proceedings recorded by mechanical stenography.
`Transcript produced by computer-aided transcription.
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`468
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`A P P E A R A N C E S: (Cont'd.)
`
`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
`and;
`WEIL, GOTSHAL & MANGES LLP
`BY: ROBERT T. VLASIS III, ESQUIRE
` W. SUTTON ANSLEY, ESQUIRE
` MATTHEW SIEGER, ESQUIRE
`SUNDIP KUNDU, ESQUIRE
`ADAM BANKS, ESQUIRE
`NATALIE KENNEDY, ESQUIRE
` 2001 M Street NW, Suite 600
` Washington, DC 20036
`
`appeared on behalf of the Plaintiffs;
`
`
`
`SAIBER LLC
`BY: JEFFREY SOOS, ESQUIRE
` KATHERINE A. ESCANLAR, ESQUIRE
` One Gateway Center
` Tenth Floor, Suite 1000
` Newark, New Jersey 07102
`
`and;
`WILSON SONSINI GOODRICH & ROSATI P.C.
`BY: DOUGLAS H. CARSTEN, ESQUIRE
` ELHAM FIROUZI STEINER, ESQUIRE
` ARTHUR P. DYKHUIS, ESQUIRE
`
`JAMES P.H. STEPHENS, ESQUIRE
` MICHAEL TAYLOR DIMLER, ESQUIRE
` 12235 El Camino Real
` San Diego, California 92130
`and;
`WILSON SONSINI GOODRICH & ROSATI P.C.
`BY: NICOLE STAFFORD, ESQUIRE
` 900 South Capital of Texas Hwy
` Las Cimas IV, 5th Floor
` Austin, Texas 78746
`
`
`
`appeared on behalf of the Defendants;
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`469
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`ALSO PRESENT:
`
`IN-HOUSE COUNSEL WITH SANOFI
`STEPHANIE DONAHUE, ESQUIRE
`
`IN-HOUSE COUNSEL WITH MYLAN
`THOMAS JENKINS, ESQUIRE
`STEVE FLYNN, ESQUIRE
`MATTHEW GREINER, ESQUIRE
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`I N D E X
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` DX CX RDX
`
`WITNESS: (Plaintiff's Rebuttal)
`
`ALEXANDER SLOCUM, Ph.D. 471 519 595
`(Resumed)
`
`E X H I B I T S
`
`(No exhibits were received on the record.)
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
`
`471
`
`(PROCEEDINGS held in open court before The
`
` HONORABLE STANLEY R. CHESLER, United States
`
`District Judge, on December 5, 2019.)
`
`THE DEPUTY CLERK: All rise.
`
`THE COURT: Be seated, everybody. Good afternoon.
`
`MR. DESAI: Good afternoon, Your Honor.
`
`THE DEPUTY CLERK: 1:10 start.
`
`THE COURT: Good afternoon. All right. Let's
`
`proceed.
`
`Ready to go?
`
`MR. DESAI: Yes.
`
`ALEXANDER SLOCUM, PH.D.
`
`having been previously duly sworn, testified as follows:
`
`DIRECT EXAMINATION
`
`(Resumed)
`
`BY MR. DESAI:
`Q. Good afternoon, Dr. Slocum. We'll start off where we
`
`were from yesterday, which is -- I think we were wrapping up
`
`the discussion of the calculations that you had done.
`
`Now, basically, the analysis you've done in this case
`
`was injection force, the important design consideration at the
`
`time of invention?
`A. Yes, it was.
`Q. And have you heard that in some of the testimony, you've
`
`read that in some of the testimony at this trial?
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`472
`
`A. Yes.
`
`MR. DESAI: Let's go to Exhibit PTX-661.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. What is the title of this article?
`A. "Pre-filled Insulin Device With Reduced Injection Force:
`
`Patient Perception and Accuracy."
`Q. Okay. And is this a paper you reviewed in formulating
`
`your opinions?
`A. It is.
`Q. And what is this paper about?
`A. So this paper is about the FlexPen device and then how it
`
`evolved into what is called the Next Generation FlexPen
`
`device.
`Q. Okay. Great. And this evolution of FlexPen to the Next
`
`Generation FlexPen occurred after Sanofi introduced the
`
`SoloSTAR?
`A. Correct.
`Q. And let's go -- why don't we go to page 5, and go
`
`straight to the "Conclusion." Can you -- we've highlighted
`
`two sentences there.
`
`Can you tell us what this talks about with respect to
`
`the FlexPen and the Next Generation FlexPen?
`A. Okay. The paper went through how the FlexPen evolved and
`
`what was done and tested to create what was called the Next
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
`
`473
`
`Generation FlexPen.
`
`And then the paper concludes: "The modifications made
`
`to NGFP have resulted in a significant 30 percent reduction in
`
`injection force compared with FP."
`
`That's the FlexPen.
`
`"These changes have contributed to NGFP being
`
`considered more 'simple and comfortable' to be used by
`
`patients."
`Q. What does this tell us about how a POSA would
`
`view the modification as being proposed by defendants
`
`Steenfeldt-Jensen and FlexPen that would have increased the
`
`injection force?
`A. Well, you would not want to increase the force because it
`
`would send you back in time to make a worse product.
`
`The paper goes through quite a bit of detail on
`
`injection force you can measure and get a number, but patients
`
`feel it. And in the context of feeling the lower force, they
`
`actually are happier and are more likely to comply with the
`
`medication.
`
`That's what it means by "simple" and "more
`
`comfortable," the patients are feeling.
`Q. Okay. Let's turn to the Steenfeldt-Jensen specification.
`
`I would like to cover certain parts of the specification that
`
`Mr. Leinsing discussed.
`
`Do you agree that the specification that
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
`
`474
`
`Steenfeldt-Jensen expressly suggests modifying the fifth
`
`embodiment into swap -- swapping the driver tube and the
`
`threads?
`A. No, there's nothing in there to suggest that.
`Q. Okay. Let's go through some of these passages.
`
`MR. DESAI: We're going to start with PTX-2282.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. We have up here on the screen column 3, lines 15 to 20;
`
`and column 3, lines 31 to 47.
`
`Do you recall hearing Mr. Leinsing testify about these
`
`passages?
`A. I do.
`Q. Would a POSA have interpreted these passages as applying
`
`to the fifth embodiment?
`A. No.
`Q. Okay.
`
`MR. DESAI: Let's go to column 2, lines 40 to 53.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. All right. And you've reviewed this passage?
`A. Yes.
`Q. Okay. And what embodiments does this passage pertain to?
`A. So this just pertains to the first two embodiments, which
`
`were covered at this point in the patent.
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
`
`475
`
`Q. Okay. And the passages at column 3 that we just
`
`discussed, do they immediately follow this discussion
`
`pertaining to the first and second embodiment?
`A. They do.
`Q. Okay. To be clear, how different are Steenfeldt-Jensen's
`
`first and fifth embodiment?
`A. They are very different.
`
`MR. DESAI: Let's take a look at demonstrative 9.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. And this is an image, figure 2, annotated. And also
`
`column 6, lines 54 to 65.
`
`Could you please explain -- well, first of all, what is
`
`this describing?
`A. So this is describing how the first embodiment works.
`Q. Okay. Can you please explain for the Court the
`
`differences between -- the major differences between the first
`
`embodiment and the fifth embodiment of Steenfeldt-Jensen?
`A. Okay. All of these pens require the dose to be set.
`
`The first embodiment says you grab the barrel of the
`
`pen, and now you grab below the barrel of the pen to the part
`
`that holds the ampule of insulin, and you rotate that body
`
`part that holds the ampule of insulin.
`
`And when you do that, you're back-driving the screw
`
`threads and all the mechanism that leads from the ampule back
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
`
`476
`
`to the dose dial sleeve.
`
`So when you're rotating that bottom part, the top dose
`
`dial sleeve, you'll see (indicating) come out. So you're
`
`indirectly dose dialing by that grabbing and back-driving,
`
`where you want to have friction, to make the dose dial sleeve
`
`come out.
`Q. And, again, how does that differ from the fifth
`
`embodiment?
`A. Okay. The fifth embodiment does exactly the opposite.
`
`It has -- you grab the body, and now you hold the dose dial
`
`sleeve itself and you directly dial it out. And then
`
`everything else stays without moving, so you're not
`
`back-driving anything in terms of below the dose dial sleeve.
`
`So the friction is irrelevant there with respect to dose
`
`dialing.
`
`In the first one, you want friction to the dose
`
`dialing, and the second one you don't need it.
`Q. Okay --
`A. I'm sorry. When I said "second," the fifth embodiment.
`
`It's not the second.
`
`MR. DESAI: Let's go to column 7, lines 41 to 47.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. This is another portion of the specification that we
`
`heard Mr. Leinsing talk about.
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
`
`477
`
`Does this paragraph suggest the modification to the
`
`driver tube in Steenfeldt-Jensen's fifth embodiment?
`A. Not to the fifth.
`Q. Okay. And it says: "The shown embodiment."
`
`What embodiment would a POSA understand this is
`
`applying to?
`A. Well, this one applies to the first embodiment, because
`
`here it's talking about using the friction that I just
`
`described in the context of you are -- you want to be able to
`
`back-drive the elements to make that dose dial sleeve spin
`
`out.
`
`And what it's saying here by this swap where it says:
`
`"Embodiments may be imagined where the piston rod guide is
`
`provided in the wall," so they're swapping it, you are
`
`going to get more friction which will give you a more reliable
`
`dose dial sleeve winding out.
`
`It's going to help you, in that case, for setting the
`
`dose. It's going to hurt you when it comes time to have a
`
`higher injection force.
`Q. What part of the specification is this passage found in?
`A. Well, this is found in column 7, before there's any
`
`discussion of the fifth embodiment.
`Q. Now, there is a provisional application that relates to
`
`Steenfeldt-Jensen?
`A. There is.
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
`
`478
`
`Q. And have you reviewed that?
`A. I did.
`Q. Okay. And does the provisional application include the
`
`passages in column 3 and column 7 that we just discussed?
`A. Yes. They were in the provisional patent.
`Q. Okay.
`
`MR. DESAI: And just for clarity, let's put up
`
`PTX-1722.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. And you've reviewed this. This is the provisional
`
`application.
`A. I did.
`Q. Okay. And, for example, we have up here in the
`
`provisional application the portion of -- from column 7 that
`
`was in the Steenfeldt-Jensen patent.
`
`Is that what we have shown here?
`A. Same words.
`Q. Okay. And does this provisional application include all
`
`five of Steenfeldt-Jensen's embodiments?
`A. No, just the first two.
`Q. Okay. And what conclusion do you draw from this?
`A. Well, all these words were written when the first two
`
`embodiments were placed, and they apply to the first two.
`Q. Was there any language added to the Steenfeldt-Jensen
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
`
`479
`
`patent that ties those passages specifically to the fifth
`
`embodiment?
`A. No.
`Q. Okay. Let's move on.
`
`MR. DESAI: And we're going to go to figure 17 of
`
`Steenfeldt-Jensen. That's DTX-2282 at page 6.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. Okay. I think earlier when you were describing the
`
`Steenfeldt-Jensen fifth embodiment, you mentioned the pressure
`
`foot takes the force from the piston rod and distributes it on
`
`the rubber piston.
`
`What component is the pressure foot in figure 17?
`A. That would be component 9.
`Q. Okay. Is this a --
`
`MR. DESAI: Could we just highlight component 9,
`
`please, for the Court.
`
`BY MR. DESAI:
`Q. And is this a component that is also found in the
`
`'844 patent pen injector?
`A. It is.
`Q. Okay.
`
`MR. DESAI: Let's pull up -- why don't we pull up the
`
`priority patent, DTX-2850. And we're going to go to page 23,
`
`and this is lines 25 to 31.
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
`
`480
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. Is this a description of a pressure foot in the
`
`Great Britain priority patent?
`A. It is. That pressure foot, 22, would be the same thing
`
`as the little disk in the other patent, 9.
`Q. Okay. Let's take a look at Chanoch, which is another
`
`patent that's been referenced.
`
`MR. DESAI: It's DTX-2280. We're going to go to
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`figure 3, page 4.
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`(Exhibit published.)
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`BY MR. DESAI:
`Q. And what item is the piston rod?
`A. The piston rod is 120.
`Q. Does this piston rod have a pressure foot?
`A. It does. It would be 122. 125 is a feature on the
`
`pressure foot, I think.
`Q. I think if you look at the text, it might -- no. Let's
`
`see . . .
`
`MR. DESAI: Let's pull up column 5, lines 45 to 50,
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`on page 9, please.
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`THE WITNESS: It's one or the other.
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`MR. DESAI: Can we please pull up page 9. It's
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`column 5, lines 45 to 50, please.
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`(Exhibit published.)
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`BY MR. DESAI:
`Q. And I see you highlight 125 there.
`
`Does this paragraph tell us what the pressure foot is?
`A. Oh, enlarge -- it is 125, right. 122 is -- I'm sorry.
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`It's just talking about the distal end, right. So it includes
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`the pressure foot, yes.
`Q. Okay. And does the piston rod in Chanoch, does that
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`rotate when it is pushing on the cartridge piston?
`A. In Chanoch that piston rod is not rotating when it's
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`pushing.
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`MR. CARSTEN: Your Honor, I believe this witness in
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`his expert reports talked about Chanoch referring to a
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`pressure foot, so I object to this as a new opinion.
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`MR. DESAI: Your Honor, Dr. Slocum has a section in
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`his report that discusses all of these references and has
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`figures and shows each of the items in the figures, and that's
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`what we're talking about here.
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`MR. CARSTEN: Well, I thought he was talking -- my
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`recollection here is he's now talking about the effect of the
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`pressure -- of the fit of the -- of this pressure foot in
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`terms of how the operation of Chanoch functions.
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`I don't remember that being a source of any testimony
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`or a source of a paragraph in his expert report at all. It
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`seems like they're trying to take now some pieces and say that
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`the '844 and Chanoch and all these have a pressure foot, and
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`482
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`that's not anywhere synthesized in any expert report that I've
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`seen from Dr. Slocum.
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`MR. DESAI: Your Honor, in Dr. Slocum's report he has
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`every one of these references. He has the figures up there,
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`and he's highlighted components and he's identified them.
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`That's exactly what we're doing. And he already --
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`I'm sorry. He already described in his earlier testimony
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`yesterday what a pressure foot is and what it does.
`
`THE COURT: Objection overruled. Let's go.
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`MR. CARSTEN: Very good, Your Honor.
`
`MR. DESAI: Okay. Let's go to the Giambattista
`
`reference, and that's DTX-2283, figure 9 on page 5.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. Does Giambattista have a pressure foot?
`A. It also does. That's item 3 there that's highlighted.
`Q. Again, you mentioned earlier when you were talking about
`
`Steenfeldt-Jensen what this pressure foot does.
`
`Why do all these pen injectors have a pressure foot
`
`that's used to push on the rubber piston?
`A. It's as I explained yesterday, the rubber is soft. And
`
`the friction is between the rubber and the glass walls.
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`And if you push in the middle of the rubber, you'll
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`dent the rubber, and then you won't -- you'll be moving the
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`piston rod, denting the rubber, and getting no juice coming
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`483
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`out. So you'll have an inaccurate dispensing, particularly at
`
`low doses. Like for children, for example.
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`So you need to take the force from the piston rod,
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`because the piston rod is real small, and put it out --
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`distribute it on the rubber so you don't deform the rubber.
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`MR. CARSTEN: Your Honor, again, this is all brand
`
`new. This is -- the dent on the rubber and that it's
`
`inaccurate, et cetera, this is all brand-new opinion
`
`testimony.
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`THE COURT: Overruled.
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`MR. CARSTEN: Okay.
`
`BY MR. DESAI:
`Q. You mentioned accurate dosing.
`
`Is accurate dosing a requirement?
`A. It's a very important requirement, because if you
`
`don't -- my understanding, from what I've heard from the
`
`doctors, if you don't get the right amount of insulin, you can
`
`cause a lot of damage to the body.
`Q. Did you hear Mr. Leinsing testify yesterday that the
`
`pressure foot in Steenfeldt-Jensen, which he called a "thrust
`
`washer," could be eliminated?
`A. That's what he said.
`Q. Did Mr. Leinsing present this as a motivation in his
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`opening or expert report on the issue of invalidity?
`A. I didn't read that anywhere.
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`484
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`Q. Do you agree that the pressure foot can be eliminated?
`A. I don't think you can.
`Q. Okay. Let's go to Chanoch again quickly.
`
`MR. DESAI: And we're going to go to DTX-2280, and
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`pull up the first page.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. When was this patent filed and issued?
`A. It was filed September 19, 1995; and issued October 7,
`
`1997.
`Q. Did you hear Mr. Leinsing briefly discuss Chanoch?
`A. I did.
`Q. And I think you heard Mr. Leinsing explain that Chanoch
`
`shows a threaded driver tube.
`A. I think he said that.
`Q. Does Chanoch provide any motivation for modifying the
`
`fifth embodiment of Steenfeldt-Jensen?
`A. It does not.
`Q. Okay. What would happen if a POSA used the threaded
`
`driver with the Steenfeldt-Jensen fifth embodiment?
`A. Well, that was the force loops we were talking about
`
`yesterday. So you would increase the force, the injection
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`force required, if you took this old design and brought it
`
`forward.
`Q. Why would a POSA take this older patent in Chanoch and
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`485
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`use it to make Steenfeldt-Jensen's fifth embodiment worse?
`A. I don't think a POSA would be motivated to do that.
`Q. All right. Well, that covers the FlexPen,
`
`Steenfeldt-Jensen, and Chanoch.
`
`We're going to move on to Giambattista, and we've
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`already talked -- let's start with claim 21.
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`MR. DESAI: Can we pull up demonstrative 10.
`
`(Exhibit published.)
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`BY MR. DESAI:
`Q. Okay. And what limitation of claim 21 is missing from
`
`Giambattista?
`A. It lacks the piston rod holder rotatably fixed to the
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`housing.
`Q. Okay.
`
`MR. DESAI: Can we pull up demonstrative 11.
`
`(Exhibit published.)
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`BY MR. DESAI:
`Q. And here we have figure 4 of Giambattista. We have
`
`column 3, lines 51 to 58, and we have the claim language from
`
`the '844 patent at the top.
`
`First, what item does Mr. -- component is Mr. Leinsing
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`relying on as being the piston rod holder?
`A. He says the retract nut 4 is the piston rod holder.
`Q. Okay. And can you explain why the retract nut 4 in
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`Giambattista is not a piston holder rotatably fixed to the
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`486
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`housing?
`A. Okay. So, first, rotatably fixed to the housing means
`
`it's fixed, it's attached, whether it's molded or bonded or
`
`whatever, but it's fixed. Fixed is fixed.
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`The Giambattista patent is particularly about the pen
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`injector that you can re-use. So when you're done injecting
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`the first vial, you can take out the old vial. And when you
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`put in the new vial, you need to reset the internal
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`components.
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`It's that when you're exchanging the vials, the retract
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`nut is specifically designed to disengage and freely rotate.
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`That allows you to reset your mechanism. Once it's reset,
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`it is engaged for injection. So it's more like a clutch than
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`an element that is fixed on there.
`Q. So because the retract nut is designed to be rotated
`
`relative to the housing by the user as part of the operation
`
`of the device, does that mean it cannot be the claimed piston
`
`rod holder rotatably fixed to the housing?
`A. Correct.
`
`MR. DESAI: That covers claim 21.
`
`We're going to move on to claim 22, and this is --
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`we're going to do JTX-3 at page 14.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. This is the patent.
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`487
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`Okay. And just quickly, what does claim 22 require?
`A. Claim 22 requires the drug delivery device of claim 21,
`
`where the piston rod has a circular cross-section.
`Q. Does Steenfeldt-Jensen's fifth embodiment include a
`
`piston rod having a circular cross-section?
`A. It does not.
`Q. Does the FlexPen include a piston rod having a circular
`
`cross-section?
`A. It does not.
`Q. Does Giambattista include a piston rod having a circular
`
`cross-section?
`A. It does not.
`Q. Okay. Let's go through each one of those quickly.
`
`MR. DESAI: And we're going to start with
`
`Steenfeldt-Jensen again, figure 17, the abstract. And
`
`column 11, lines 15 to 19, please.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. Okay. Well, here is figure 17. What item is the piston
`
`rod?
`A. 6.
`Q. Okay. And what is the cross-sectional shape of this
`
`piston rod in Steenfeldt-Jensen?
`A. It is rather rectangular, so it's a rounded end
`
`rectangle.
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`488
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`Q. Okay.
`
`MR. DESAI: And can we have the abstract, which is on
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`page 1.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. And what does this tell us about the cross-section of the
`
`piston rod?
`A. It says: "A piston rod with a non-circular cross-section
`
`having an outer thread."
`Q. Okay. What is the purpose of Steenfeldt-Jensen having
`
`these flat sides that run the length of the piston rod?
`A. Simply, they want to transmit torque to the piston rod
`
`from the driver. So it's kind of like a screwdriver into a
`
`slot, a screw head.
`
`So that's a corresponding non-round hole -- which is
`
`the correct language -- on the driver, so it engages the
`
`piston rod. And as the driver tube turns, it transmits torque
`
`to the piston rod to spin it into the threaded nut to advance
`
`the piston rod to squirt out the insulin.
`Q. Okay. So because of this non-circular cross-section,
`
`that's why the driver tube and piston rod in Steenfeldt-Jensen
`
`always rotate together?
`A. Correct.
`Q. Okay.
`
`THE COURT: Let me stop you for a second.
`
`United States District Court
`Newark, New Jersey
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`489
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`When he says a "screwdriver," just so I get it into my
`
`head, is it more like an Allen wrench?
`
`THE WITNESS: Yeah. Any sort of geometric shape that
`
`when you put the -- excuse the term -- the male into the
`
`receiving socket and you turn it, you're transmitting torque
`
`because of the geometric shapes. If they were round, it would
`
`just spin.
`
`THE COURT: Okay.
`
`BY MR. DESAI:
`Q. How does the FlexPen's piston rod cross-sectional shape
`
`compare to Steenfeldt-Jensen?
`A. The -- I'm sorry. Again?
`Q. Well, sorry. How does the FlexPen's piston rod
`
`cross-sectional shape compare to Steenfeldt-Jensen?
`A. They're very similar. It's basically the same thing.
`
`When you look at it, it looks like a rectangle with rounded
`
`ends.
`Q. Okay.
`
`MR. DESAI: And let's go to Giambattista
`
`demonstrative 17. Figure 1, column 3, lines 39 to 43.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. And what items are the piston rod here?
`A. The piston rod here is 9 --
`Q. Okay.
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`490
`
`A. -- and they call it a "leadscrew" but it's -- a threaded
`
`piston rod is a leadscrew.
`Q. Okay. And how does the cross-section shape of
`
`Giambattista's piston rod compare to Steenfeldt-Jensen?
`A. Well, it's the same thing as it says here, flat sides 94
`
`on leadscrew 9.
`Q. And what does the -- what do those flat sides on the
`
`leadscrew in the piston rod in Giambattista engage with?
`A. Well, they're going to -- it says here that this is
`
`on the retract nut. The retract nut has that same
`
`rectangular-ish shaped hole. You mentioned an Allen wrench.
`
`So think of it as a square drive.
`
`So it has that mating hole, this rectangular hole, that
`
`mates with the piston rod's flats, so the retract nut can hold
`
`that piston rod.
`Q. Okay. Now, are your opinions regarding the FlexPen's
`
`piston rod and Giambattista's piston rod the same as your
`
`opinion regarding Steenfeldt-Jensen's piston rod?
`A. They are.
`Q. Okay. And you were here when Mr. Leinsing testified and
`
`said, in his opinion, the Steenfeldt-Jensen piston rod has a
`
`circular cross-section based on the ends of the piston rod;
`
`right?
`A. I heard that.
`Q. Okay. Do you agree with that opinion?
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
`
`491
`
`A. No.
`Q. Okay. Can you explain why?
`A. Okay. A piston rod or a leadscrew, the things on the
`
`very ends that aren't doing the screwing, those are called
`
`journals or end journals.
`
`So end journals can have a lot of different shapes,
`
`depending on how you're going to hold that piston rod or
`
`leadscrew, and what you're going to do with it. It can be
`
`round, so it's simply a bearing. It can be some sort of a
`
`polygon to transfer torque to it. There's a bunch of things.
`
`But the piston rod, that's the thing that is threaded
`
`that does the work of providing the axial force, that's where
`
`you look at the cross-sectional shape of it.
`Q. So when you're looking to determine the cross-sectional
`
`shape of the rod, you look at the length of the rod; right?
`A. Yeah, over the length of that rod that's doing that work,
`
`if you look at -- if I take a cross-section, what is the
`
`effective shape that a POSA will use to design the rod.
`Q. Now, Mr. Leinsing has also argued the piston rod of the
`
`'844 patent has a non-circular cross-section because it has
`
`threads.
`
`Do you agree?
`A. I do not agree with him.
`Q. How does a POSA assess the cross-section of a threaded
`
`screw, like what's in the '844 patent?
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`492
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`A. Okay. So a POSA wants to design the screw to take a
`
`torque and not twist in half and also to not -- when you push
`
`on it, from the forces, not to buckle.
`
`There are many different thread shapes that could do
`
`lots of different things, but they all will have the bottom of
`
`the thread or the root. So a POSA says, You can serve it.
`
`I'm going to ignore the thread and just take this shaft where
`
`the root of the thread is, because that's going to be the
`
`shape that will govern the strength of the rod.
`
`So the POSA can now design the rod by picking that root
`
`diameter to have the torsional strength, axial buckling,
`
`everything they need. They can then -- they're free to then
`
`pick whatever thread they need, or they may have to change to
`
`this thread, but it won't affect the basic calculation that
`
`they did in order to initially design it and make it work.
`
`MR. DESAI: Well, that covers the 103 issues.
`
`And so we're going to move on to 112, and let's go to
`
`demonstrative 19.
`
`(Exhibit published.)
`
`BY MR. DESAI:
`Q. Starting here, we're starting with the limitations in the
`
`claim that are a driving member comprising a third thread, and
`
`a piston rod comprising an internal thread or an external
`
`thread that is engaged with the third thread.
`
`Now, you've heard Mr. Leinsing testify about these
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`DIRECT EXAM - A. SLOCUM - BY MR. DESAI
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`493
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`yesterday -- two days ago?
`A. I did.
`Q. Right. And is it your opinion that these limitations
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`have written description support?
`A. They do.
`Q. And what is your opinion regardin
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