`
`364
`
` UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`________________________________
`SANOFI-AVENTIS U.S. LLC,
`SANOFI-AVENTIS DEUTSCHLAND
`GMBH, and SANOFI WINTHROP
`INDUSTRIE,
` CIVIL ACTION NUMBER:
` Plaintiffs,
`vs. 2:17-cv-09105-SRC-CLW
`MYLAN GMBH, BIOCON LTD.,
`BIOCON RESEARCH LTD.,
` VOLUME 3
`BIOCON SDN, BHD., and
`
`BIOCON S.A.,
` TRIAL
` Defendants.
`________________________________
`MARTIN LUTHER KING BUILDING & U.S. COURTHOUSE
`50 Walnut Street, Newark, New Jersey 07101
`December 4, 2019
`Commencing at 2:00 p.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
`
`and;
`
`Karen Friedlander, Official Court Reporter
` friedlanderreporter@gmail.com
` (856) 756-0160
`Proceedings recorded by mechanical stenography;
` transcript produced by computer-aided transcription.
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 1/47
`
`
`
`
`
`365
`
`A 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
` KATHRYN KANTHA, 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
` 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
`
`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
`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
` For the Defendants.
`
`
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 2/47
`
`
`
`W I T N E S S I N D E X
`
`
`
` WITNESS
`DR. WILLIAM CURTIS BIGGS
`DIRECT EXAMINATION OF DR. WILLIAM CURTIS BIGGS BY MS.
`STEINER:
`CROSS EXAMINATION OF DR. WILLIAM CURTIS BIGGS BY MR.
`VLASIS:
`REDIRECT EXAMINATION OF DR. WILLIAM CURTIS BIGGS BY
`MS. STEINER:
`DR. ROBERT DEFOREST MCDUFF
`DIRECT EXAMINATION OF DR. ROBERT DEFOREST MCDUFF BY
`MR. DYKHUIS:
`CROSS EXAMINATION OF DR. ROBERT DEFOREST MCDUFF BY
`MR. VLASIS:
`DR. ALEXANDER HENRY SLOCUM
`DIRECT EXAMINATION OF DR. ALEXANDER HENRY SLOCUM BY
`MR. DESAI:
`
`366
`
`PAGE
`367
`367
`
`382
`
`400
`
`402
`403
`
`425
`
`439
`440
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`United States District Court
`Camden, New Jersey
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 3/47
`
`
`
`McDUFF - CROSS - VLASIS
`
`439
`
`Is the plaintiff ready to proceed?
`MR. DESAI: Your Honor, the plaintiffs call
`Dr. Alexander Slocum.
`THE COURT: Please sit down.
`THE DEPUTY CLERK: Please place your left hand on the
`Bible and raise your right.
`(DR. ALEXANDER HENRY SLOCUM, having been duly sworn as a witness,
`testified as follows:)
`THE DEPUTY CLERK: Please state your full name for
`the record.
`THE WITNESS: Alexander Henry Slocum.
`THE DEPUTY CLERK: Please spell your last name.
`THE WITNESS: S-L-O-C-U-M.
`THE DEPUTY CLERK: Thank you.
`MR. CARSTON: Your Honor, I don't mean to interfere
`with my learned friend's examination, there is one exhibit for
`which we've been unable to resolve a dispute. It's an exhibit
`that the witness hasn't used at all in his expert reports. It
`came up for the first time with my infringement --
`noninfringement expert, Michael Quinn. I don't know the
`purpose which they're trying to use it, but I've been assured
`by Mr. Desai that they will try to use it.
`May I just see how the examination goes, see what
`they try to do with it, and raise an objection at that point?
`THE COURT: You may.
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 4/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`440
`
`MR. CARSTON: Thank you, Your Honor.
`THE COURT: Proceed.
`(DIRECT EXAMINATION OF DR. ALEXANDER HENRY SLOCUM BY MR. DESAI:)
`Q
`Good afternoon.
`A
`Good afternoon.
`Q
`Could you please state your name for the record?
`A
`Alexander Slocum Henry.
`Q
`What is your occupation, Dr. Slocum?
`A
`I am a professor of mechanical engineering at the
`Massachusetts Institute of Technology in Cambridge,
`Massachusetts.
`Q
`Dr. Slocum, why are you here today?
`A
`I'm here today to provide technical opinions regarding the
`'844 patent.
`Q
`What issues are you here to testify about specifically?
`A
`On the validity of the patent.
`Q
`Okay. And have you ever previously offered expert
`opinions on the issue of patent invalidity?
`A
`I have.
`Q
`About how many times have you done that?
`A
`Probably a couple of dozen.
`Q
`Okay. Let's talk about your qualifications.
`Please tell us about your education.
`A
`I have a bachelor of science, master of science, and Ph.D.
`in mechanical engineering, all from MIT in the years 1982, '83,
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 5/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`441
`
`and '85.
`Q
`After you received your Ph.D., please just walk us through
`your employment history.
`A
`Well, while I was doing my Ph.D., starting 1983, I was
`full time at the National Bureau of Standards in Gothenburg,
`Maryland. And I was there -- remained until 1986, and then I
`was an assistant professor of civil engineering at MIT in
`construction automation, machinery design.
`From 1989 to 1991, I had an Oak Ridge fellowship and another
`fellowship from the Royal Society to work on the Star Wars
`Missile Defense Program, various machinery for that.
`In 1991 I returned to MIT as an assistant professor of
`mechanical engineering, and then associate, tenured and full
`professor, which I am now.
`Q
`Which types of classes do you teach at MIT?
`A
`My focus is precision machine design, machine elements in
`the broad area of design, and manufacturing, which ties it all
`together.
`Q
`Any other classes you teach?
`A
`Well, I teach quite a lot of professional classes for
`industry. There's a specific class in the precision machine
`design that the version of that is called Design of Medical
`Devices. So that's a very specific, focused class I've done
`for many years.
`Q
`You teach both graduates and undergraduates?
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 6/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`442
`
`I do. I have undergraduates in my classes and also
`A
`graduate students, and then I also each industry classes.
`Q
`Do you write any textbooks?
`A
`I have two textbooks. The first one is "Precision Machine
`Design." That was published in 1995. That's a tome heavily
`focused on that topic. And then I have another introductory
`book. It's called "Fundamentals of Design" that I published in
`early the 2000s, and that's freely available for downloads on
`the web.
`Q
`It's the second time you've said, "precision machine
`design." Could you explain to us what that means and how it
`relates to the subject matter in this case.
`A
`Okay.
`So precision is the ability of a device or instrument to
`repeat. Accuracy is, you know, how exact, but the precision is
`if I use a device over and over, will it do the exact same
`thing each time, how well.
`Q
`Is a pen injector a precision machine?
`A
`It is, because the patient is instructed to take so many
`units of insulin to perform the function that the doctor wants.
`And so the pen injector has to give you, if you dial in a
`certain number of units, every day you're supposed to take 10,
`20, whatever the doctor said, you want to make sure you get
`that exact dose day in and day out.
`Q
`Well, throughout your academic appointment at MIT, have
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 7/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`443
`
`you done any work in industry?
`A
`I have. Over the years, I worked specifically with
`companies to develop new products, to fix products they have
`that aren't working. I've started several very successful
`companies. We design, manufacture, deliver products, employ
`lots of people to do so. So it gets pretty big.
`And I also worked, in 2013, I was the assistant director for
`advanced manufacturing at the Office of Science and Technology
`Policy in the White House.
`Q
`Dr. Slocum, do you have any patents?
`A
`Current, it's like 133 or so. A lot of foreign ones, and
`a bunch more in the pipeline. I'm still an active designer of
`stuff.
`Q
`Are any of your patents relevant to the subject matter in
`this case?
`A
`They are. Quite a few of the patents are on drive
`mechanisms for machines and instruments.
`As we'll see, it's lead screws, gears, those sort of machine
`elements are really the heart of this '844 matter, and that
`happens to be my particular specialty, is how to make those
`elements and machines that use them to get whatever level of
`performance you need.
`Q
`Have you received any awards for your work as a mechanical
`engineer?
`A
`Yes, there's a bunch of awards listed in my CV from
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 8/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`444
`
`professional societies. I have the ASME Leonardo DaVinci,
`award, the Machine Design award from ASME, American Society of
`Mechanical Engineers. I do a lot of work in energy systems, so
`the Thar Energy award because we do a lot of fluids works.
`A dozen, or I think it's exactly 11, they're called R&D 100
`awards for one of the 100 most significant new technological
`products, you know.
`And I also have a Department of Commerce bronze medal for
`superior federal service for my government work.
`MR. DESAI: Can we please turn to PTX-1647.
`BY MR. DESAI:
`Q
`And I think you have it in your binder up there as well.
`Is this a copy of your CV?
`A
`It is. It's my faculty personnel record, which includes
`all the classes, all the publications, all the patents to date,
`names of all my students, dozens of doctoral students, et
`cetera. It's all in there.
`MR. DESAI: Your Honor, we offer Dr. Slocum as an
`expert in the field of mechanical engineering, mechanisms and
`mechanical systems, including medical devices.
`MR. CARSTON: No objection, Your Honor.
`THE COURT: So deemed.
`MR. DESAI: So we're planning to address the 103
`issues first, then we will turn to the 112 issues.
`MR. CARSTON: Your Honor, I don't mean to interfere,
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 9/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`445
`
`but the exhibit -- the demonstrative exhibits that I was just
`handed differ radically from what I was given last night
`pursuant to the pretrial order.
`I'm trying to figure out exactly what's different.
`It's not just an order issue, however, so --
`MR. DESAI: Okay. This is a mistake. I mean, the
`demonstratives we gave are supposed to be the ones from last
`night.
`
`MR. CARSTON: Please proceed then, but may I have a
`set of the demonstratives that we intend to use today that
`correspond to the ones that were disclosed?
`MR. DESAI: I probably need to take a break to do
`this to get the printouts.
`THE COURT: I don't know who to count this against.
`MR. DESAI: You can count this against us, I presume.
`THE COURT: We'll take a short break.
`MR. DESAI: Sorry, Your Honor.
`(Off the record.)
`MR. CARSTON: Your Honor, there may be some copies
`that were handed up, et cetera, but I'm sure what we will be
`shown on the screen will follow what my counsel sent last
`night, and I'm happy to proceed in that regard.
`THE COURT: Fine.
`MR. DESAI: Should we wait for --
`THE COURT: Let's go.
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 10/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`446
`
`MR. DESAI: Sorry.
`BY MR. DESAI:
`Q
`Okay. Let's go to the first demonstrative, and we're
`going to cover the level of ordinary skill in the art.
`As part of your analysis, Dr. Slocum, did you opine this to the
`level of ordinary skill in the art?
`A
`I did.
`Q
`Okay. Can you read into the record the level of skill
`that you applied.
`A
`Okay.
`It is my opinion that the correct level of ordinary skill is
`defined by a person who understands the mechanical elements
`(e.g., lead screws, clutches, gears) used in drug injection
`delivery devices as well as the principles governing the
`interactions of such mechanical elements, and further
`understands the basics of device design and manufacturing.
`That person will have a bachelor's degree in mechanical
`engineering or an equivalent degree.
`Q
`Staying on the same demonstrative, we also have up here
`Mr. Leinsing's definition of a POSA.
`And would any of your opinions change under that definition?
`A
`No, they would not.
`Q
`Now, do both of your definitions require that POSAs have
`knowledge of mechanical elements such as lead screws, clutches,
`pistons that are found in drug delivery devices?
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 11/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`447
`
`They do.
`A
`All right. Dr. Slocum, why do you feel equipped to
`Q
`testify here today as to how a POSA would understand the '844
`patent and the prior art?
`A
`Well, I've been working in this field since I was a very
`young person from building hot rods to analyzing things all
`through my undergraduate and graduate education, my education
`at the Bureau of Standards, and as a result of all this, I have
`a real passion for devices and how they work.
`I've been teaching it to students and practicing professionals
`in industry since 1986, so over three decades in the field.
`And I've won a bunch of very important teaching awards because
`I like to -- I'm able to put myself in the mind of the student
`at the time to help them best understand and learn, and that's
`what I like to do. So I think I'm qualified as a POSA too.
`Q
`Okay. I think we can get right in the obviousness case.
`Dr. Slocum, are you familiar with the opinions offered by
`defendants' expert witness, Mr. Leinsing, regarding obviousness
`of claims 21, 22, 25 and 30 of the '844 patent?
`A
`I am.
`Q
`Did you hear Mr. Leinsing testify yesterday?
`A
`I did.
`Q
`And you've read his expert reports that he submitted on
`the issues of invalidity. Right?
`A
`I did.
`
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 12/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`448
`
`Okay. And Dr. Slocum, I think we you already mentioned,
`Q
`you've offered opinions in other cases before.
`Have you offered opinions on the issue of obviousness?
`A
`I have.
`Q
`And have you been on both sides of the fence?
`A
`I have.
`Q
`And what is your process for assessing whether a claim is
`obvious or not obvious?
`A
`Well, I need to put myself in the mind of a POSA. That's
`the person who is practicing at the time. And you, as a POSA,
`you look at all these elements, these Legos, I could call them,
`that you know about, that are before you, and then I have to
`ask myself the question, would I combine any of these to
`achieve the function that is the subject here?
`And physics is the driver as, does this makes sense, that,
`would I do this. When I say "physics," that's all-encompassing
`with how things interact. For example, Newton's laws.
`Q
`Have you applied that same process in this case?
`A
`I have.
`Q
`So let's go to the second demonstrative. And like I said,
`we're going to start with the obviousness case.
`Just quickly tell us what we have up on this slide.
`A
`We have here the three pieces of evidence that I have to
`consider: Steenfeldt-Jensen's fifth embodiment from the
`Steenfeldt-Jensen patent you've heard about;
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 13/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`449
`
`The FlexPen, this happens to be a computer model of it;
`And then the Giambattista '095 patent device.
`And these are solid models or computer models, so they can be
`colored and understood what the elements are.
`Q
`And there was also, I think, a fourth reference that was
`briefly referenced yesterday, which is Chanoch?
`A
`Correct.
`Q
`In your opinion, are the claims, asserted claims obvious
`in view of Steenfeldt-Jensen, FlexPen, Giambattista, and/or
`Chanoch?
`A
`I do not believe they are obvious in light of those
`references.
`Q
`Now, Steenfeldt-Jensen, Giambattista, and Chanoch, those
`are U.S. patent publications. Right?
`A
`They are.
`Q
`And those patents are cited on the face of the '844
`patent?
`A
`They are.
`Q
`And then if we go to DTX-2890, this has shown up a few
`times already.
`And are you familiar with this document?
`A
`I am.
`Q
`And what is this document?
`A
`This device -- excuse me, document, describes the FlexPen.
`It has a number of computer images, cross sections about the
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 14/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`450
`
`FlexPen, and discusses how it's -- it's put together.
`Q
`Okay. So when we talk about the FlexPen, we're talking
`about the pen injector that's shown, for example, in this
`document, DTX-2890?
`A
`Yes.
`Q
`Okay. And quickly, I think we've heard this before as
`well, how does the FlexPen relate to Steenfeldt-Jensen fifth
`embodiment?
`A
`The FlexPen is the physical device that corresponds to the
`fifth embodiment of that Steenfeldt-Jensen patent.
`Q
`Okay. And for purposes of your technical analysis and
`opinions, have you assumed that the FlexPen is prior art?
`A
`I have.
`Q
`Okay. Do you have a slide summarizing your opinions on
`non-obviousness that we're going to go through?
`A
`I do.
`Q
`All right.
`MR. DESAI: Let's go to the next demonstrative, 3.
`BY MR. DESAI:
`Q
`Could you please summarize the opinions, and then we'll go
`through each of these in more detail.
`A
`Okay.
`The first one is, I believe, that Claim 21 is not invalid over
`this prior art because the proposed modification to the prior
`art would increase the injection force significantly and that
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 15/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`451
`
`would send you back in time, and a POSA would not do that.
`Next, I believe Claim 21 is not invalid over Giambattista, the
`'095 patent, because Giambattista lacks this piston rod holder
`element that is rotatably fixed to the housing. The element in
`Giambattista during the normal operation of the pen by the user
`actually disconnects, so it's really more of a clutch than it
`is a fixed holder.
`And then in Claim 22, in summary, is not invalid because none
`of the prior art discloses a piston rod with a circular cross
`section. All of the prior art is noncircular, so torque can be
`transmitted to the rod through those noncircular features.
`Q
`All right. So we will go to the next demonstrative, and
`we're going to start with that first opinion up there.
`And like you said, I think, you understand that defendant --
`the starting position -- I'm sorry, the starting point for the
`obviousness argument, with respect to Steenfeldt-Jensen, is
`Steenfeldt-Jensen's fifth embodiment.
`A
`Yes.
`Q
`Okay. And for purposes of analyzing Claim 21, is there
`any difference between Steenfeldt-Jensen's fifth embodiment and
`the FlexPen?
`A
`No.
`
`MR. DESAI: Let's pull up JTX-3. This is the patent,
`Page 14, and we're going to look at the claim.
`BY MR. DESAI:
`
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 16/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`452
`
`And we've pre highlighted some limitations up here. The
`Q
`driving member comprising a third thread, the piston rod
`comprising an internal/external thread engaged with the driving
`member thread, the driving member is configured to rotate
`relative to the piston rod, and then last, the piston rod and
`the driving member are configured to rotate relative to one
`another during dose dispensing.
`Does Steenfeldt-Jensen's fifth embodiment practice these
`highlighted limitations?
`A
`They do not.
`Q
`Okay. Let's talk about the fifth embodiment, and we're
`going to have another demonstrative here. Okay.
`And on the left side, what do we have illustrated?
`A
`This is Steenfeldt-Jensen's fifth embodiment, and I've
`annotated it to show the key features and elements.
`Q
`Well, what are the two features that you've annotated?
`A
`Okay. You have in green there, it's called the driver
`tube, and that has a noncircular bore. The driver tube is what
`rotates, and its noncircular, roughly rectangular, bore mates
`with that yellow, the piston rod, which is also noncircular, so
`that allows me to turn the piston rod.
`The nut element in yellow -- excuse me, blue, it has threads
`which you see there with the pink wiggly lines. That
`represents the thread in that nut element that corresponds and
`mates with the thread in the yellow piston rod.
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 17/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`453
`
`So when the driver tube is rotated, for example, during
`injection, it acts like a spine to rotate the yellow piston
`rod. The yellow piston rod rotating, it's threaded, and it's
`in a threaded nut, so it will advance downward axially.
`Q
`Okay. So if we can summarize that in pieces, the piston
`rod is in yellow.
`A
`Correct.
`Q
`And it is mated with that green driver tube that's in
`green by the flat sides?
`A
`Correct. It has a noncircular cross section that mates
`with the noncircular hole in the green driver tube.
`Q
`Okay. When the driver tube rotates, the piston rod
`rotates with it?
`A
`Correct.
`Q
`Okay. And then the nut element in blue, is that fixed to
`the housing?
`A
`It is.
`Q
`And that has threads that mate with the piston rod?
`A
`It does.
`Q
`And so when that piston rod rotates, it also moves axially
`downward?
`A
`That's how a screw and a nut works.
`Q
`Okay. And when it moves axially down and it's rotating,
`is that how medicine or medicament is dispensed?
`A
`Right.
`
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 18/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`454
`
`At the bottom there you see where the piston rod ends and it
`mates with that black disk. That's called a pressure foot.
`The little red lines down at the bottom represent the rotating
`interface between that rotating piston rod and that pressure
`foot. The pressure foot takes the force from the piston rod
`and distributes it on that rubber -- it's not labeled, but the
`gray thing is the rubber stopper, it's sometimes called the bum
`in the glass vial. So when you're pushing down and you're able
`to displace the rubber down, that pushes the juice out of the
`pen to deliver the dose.
`Q
`Okay. And the FlexPen, does that work in the same way?
`A
`Ostensibly, there's some details in -- in -- but
`ostensibly, yes.
`Q
`Okay. So I think it's clear that Steenfeldt-Jensen's
`fifth embodiment lacks the threaded piston rod and driver and
`the relative rotation.
`So how are defendants and Mr. Leinsing proposing that the
`device be modified to render Claim 21 obvious?
`A
`Okay. On the right, you see how they propose to modify.
`They have a driver tube that now the bore of the driver tube is
`threaded where before it was a straight-through bore, and then
`the nut element is -- now has a noncircular bore.
`So in some respects, it's no longer a nut, but still keep
`calling it the nut element.
`And you can see now that the pink squiggly line representing
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 19/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`455
`
`the thread is now up in the driver bore, and the orange
`straight lines representing that corresponding, mating,
`noncircular cross section is down in the nut element, and the
`red lines at the top represent the new rotating interface at
`that much larger radius that will take those thrust forces.
`Q
`So to summarize now, we have on the right side is the
`modification to Steenfeldt-Jensen's fifth embodiment. Yes?
`A
`Correct.
`Q
`And in that -- in this modification, does the driver tube
`still rotate?
`A
`Yes, it does.
`Q
`Okay. And when it rotates, what happens to the piston
`rod?
`Okay. Because the piston rod cannot rotate because it is
`A
`mated with the noncircular bore in that fixed nut element, that
`means the piston rod can't rotate but the threaded interface
`between the driver tube, which acts like the -- what was the
`nut -- and the threaded piston rod, that is rotating. And that
`means that the piston rod will advance downward without
`rotating to push on the pressure foot which then pushes on the
`rubber stopper which then squirts out the juice.
`Q
`So in a modified version on the right, when you're
`injecting, the piston rod moves axially but does not rotate.
`Is that right?
`A
`Correct.
`
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 20/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`456
`
`Okay. Now, we heard Mr. Leinsing several times call this
`Q
`is a simple substitution.
`Do you agree that this is a simple substitution?
`A
`It is not.
`Q
`Why is it not a simple substitution?
`A
`So fundamentally, you're changing the physics of
`operation. What you're doing is you're changing what is called
`the force loop, or sometimes called the structural loop, you're
`changing the mechanics of where the energy in the system has
`dissipated and that requires some further analysis to see if
`you wanted to do that. Because in this case, you're actually
`increasing the injection force by changing the mechanics.
`Q
`Can you explain -- actually, do we have a demonstrative to
`show how this modification is changing the force loop?
`A
`We do.
`Q
`Okay.
`MR. DESAI: Let's go to Demonstrative 6.
`BY MR. DESAI:
`Q
`Okay. There's a lot of arrows on this, so we're going to
`take it slow and we're going to start on the left side. This
`is Steenfeldt-Jensen's fifth embodiment.
`Explain for us how the forces are flowing on
`Steenfeldt-Jensen's fifth embodiment.
`A
`Okay. So we're going to start at the rubber stopper on
`the bottom. The rubber stopper sits in the vial and friction
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 21/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`457
`
`between the rubber and the vial holds it in place. So the
`leads screw in any of these devices, you have to start pushing
`on the pen injector -- I'm sorry. You have -- the lead screw
`has to start pushing on that rubber stopper in order to break
`it free from that initial static friction to get it moving to
`force the juice out.
`So those orange arrows on the bottom, that represents that
`resistance force from the side walls between the rubber stopper
`and the glass.
`So let's now just follow the forces, those orange arrows as
`they go up through the device.
`This is for the one on the left.
`The forces come up, because this is Newton, action and
`reaction, remember the piston rod is pushing down on the rubber
`so the rubber is going to push back. Okay? So we're going to
`follow the pushback forces.
`The orange forces from the rubber stopper go up and they come
`into that pressure foot, and the rubber is really soft but the
`pressure foot is hard. That's why I had them going in like
`that. It collects it and now sends them up through those two
`little red lines at the bottom. That represents, depending on
`the design of that contact, that you have a small diameter lead
`screw -- lead screw is the same as a threaded piston rod -- to
`travel through.
`So on the left it's like your finger is pushing on your palm
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 22/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`458
`
`and the resistance -- all that force is going through your
`finger to your palm as your finger is rotating on your palm,
`for example. And that's fine.
`Now, the forces flow up through that lead screw, which is still
`rotating, and now they go -- the only way they can get out is
`through the mating threads of the nut. And the nut threads
`aren't rotating, they're not moving. So you will have some
`rubbing of that diameter of the threads, that small diameter of
`the piston rod there, to the threads of the nut, and now the
`forces are transferred to the nut. And now they're going to
`follow a path that will take them right up to the housing or
`the body of the device where they go into your hand. And then
`the closed loop that go from your hand to your thumb, which is
`pushing on the button, which generates the force in the screw.
`Q
`Okay. So the rotating friction interface, and
`Steenfeldt-Jensen's fifth embodiment, how is that indicated in
`your drawing on the left?
`A
`Okay. So you just follow the path of the forces, wherever
`the forces are going through relative moving elements.
`So these injection forces are going through the little red
`circles at the bottom where you've got that rotation, like your
`finger and your palm, and they go up. And then they would then
`-- where they suddenly curve out through the thread interface
`between the piston rod and the nut, that's the next place where
`you've got that relative modification or rubbing or opportunity
`United States District Court
`Newark, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Mylan Ex. 1114
`Mylan v. Sanofi - IPR2018-01676 23/47
`
`
`
`SLOCUM - DIRECT - DESAI
`
`459
`
`for loss in the mechanism.
`Q
`So the rotating friction and interface in
`Steenfeldt-Jensen's fifth embodiment is those two red lines at
`the bottom there.
`Is that right?
`A
`That's your rotating friction, your flat element. That's
`one. And then the second one is at the thread interface.
`Q
`Got it.
`Now let's talk about the modified embodiment.
`A
`Okay.
`Q
`Now, explain to us how the forces have been fundamentally
`changed in this modified embodiment.
`A
`Okay. The reason the forces are fundamentally changed is
`because you now have introduced, after the nut thread, a
`rotating element; and that produces a lot of drag, and let me
`explain why.
`Down at the rubber piston on the bottom, the gray guide, the
`forces come up and they go into that pressure foot. And now
`they go directly into the lead screw, the piston rod, and
`there's no rotation down there. That's just a static
`interface. Fine.
`They're coming up, and now the threads are