`571-272-7822
`
` Paper No. 85
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC. and PFIZER INC.,
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`____________
`
`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)1
`____________
`
`Record of Oral Hearing
`Held: January 15, 2020
`____________
`
`Before LYNNE H. BROWNE, HYUN J. JUNG,
`BART A. GERSTENBLITH, and
`JAMES A. TARTAL, Administrative Patent Judges.
`
`1 This Record is entered into each case. The parties are not authorized to use
`this joint heading and filing style in their papers. Also, Pfizer Inc., who filed
`petitions in IPR2019-00977, IPR2019-00978, IPR2019-00980,
`IPR2019-00982, and IPR2019-00987, has been joined as a petitioner in
`these proceedings.
`
`
`
`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`WESLEY E. DERRYBERRY, ESQUIRE
`Wilson Sonsini Goodrich & Rosati
`1700 K Street, NW
`Fifth Floor
`Washington, D.C. 20006-3817
`
`DOUGLAS H. CARSTEN, ESQUIRE
`Wilson Sonsini Goodrich & Rosati
`12235 El Camino Real
`Suite 200
`San Diego, CA 92130-3002
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`
`
`
`
`
`
`SUTTON ANSLEY, ESQUIRE
`ANISH DESAI, ESQUIRE
`Weit, Gotshal & Manges LLP
`2001 M Street NW
`Suite 600
`Washington, D.C. 20036
`
`
`
`2
`
`
`
`
`
`Trials@uspto.gov
`571-272-7822
` Page No. 83
`
`
`P R O C E E D I N G S
`- - - - -
`JUDGE JUNG: Well, good afternoon. Please take your seats. This is
`
`the hearing for several related cases. For the record, petitioner Mylan
`Pharmaceuticals challenges U.S. Patent Number 8,679,069 in IPR2018-
`01670, U.S. Patent Number 8,603,044 in IPR2018-01675 and IPR2018-
`01676, U.S. Patent Number 8,992,486 in IPR2018-01678 and IPR2019-
`00122, and, finally, U.S. Patent Number 9,604,008 in IPR2018-01684.
`Sanofi-Aventis owns all of these challenged patents, and Pfizer has
`been joined in several of these proceedings.
`Starting with the petitioner’s counsel, followed by patent owner’s
`counsel, please state your names for the record.
`MR. CARSTEN: Doug Carsten of Wilson Sonsini Goodrich and
`Rosati for petitioner. And along with me is lead counsel Rick Torczon, Wes
`Derryberry and Tasha Thomas. All of my office Wilson Sonsini.
`JUDGE JUNG: Thank you, Mr. Carsten. And, Mr. Wong, I see you
`in the back.
`MR. WONG: Jovial Wong from Winston and Strawn on behalf of the
`petitioner, Pfizer.
`JUDGE JUNG: Okay, thank you.
`MR. DESAI: Afternoon, Your Honors. Anish Desai from Weil
`Gotshal, I’m here on behalf of patent owner and here with me is Sutton
`Ansley.
`JUDGE JUNG: Welcome. All right. As we stated in our hearing
`order, each party has 90 minutes of total time to present its arguments.
`Petitioner will proceed first followed by patent owner. Each side may
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`reserve time for rebuttal. We plan to take a five minute break before we
`hear rebuttal arguments.
`And finally the last two reminders, please refer to your demonstratives
`by slide number and please do not interrupt to make an objection. With all
`of that said, Mr. Carsten, you may proceed when you are ready.
`
`MR. CARSTEN: Thank you. Good afternoon and may it please the
`Board.
`
`JUDGE JUNG: Mr. Carsten, how much time do you want to reserve
`for rebuttal?
`MR. CARSTEN: I believe I’m probably going to take about 50
`minutes up front and reserve about 40 but we will see how that goes. It just
`depends upon how many questions you all have for me.
`JUDGE JUNG: Okay.
`MR. CARSTEN: But that’s what I’m endearing to, endeavoring to
`do. Thank you on behalf of the petitioners here for your patience and for
`your kind attention to these IPR proceedings. There are nine of them in
`total, six of them will be heard today and we will hear the other three in
`about three weeks’ time.
`This one deals with four of the asserted patents as you indicated, Your
`Honor. And I have got a slide deck which has been filed. The first few
`slides and I’d just like to go through these and I’ll endeavor to refer to them
`by number for the benefit of Judge Browne and for the record.
`Slide 3, identifies the particular grounds for the ’069 patent, the -
`01670 case.
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`
`Slide 4 identifies for the ’044 patent, the particular grounds in claims
`for the -01675 and -01676 cases.
`Slide 5 identifies for the ’486 patent the asserted grounds and claims
`for the ’486 patent.
`And then finally slide 6 is the -01684 case for the ’008 patent, the
`claims and ground there.
`I’d like to think of these in terms of two buckets. The ’069, the ’044
`and the ’486 all share the same specification. There is one disclosed
`embodiment and the claims are all fairly similar in terms of the independent
`claims.
`And we have got a slide here, slide 7, which identifies and provides
`some of the common themes. Now there are slight differences so for
`example we have got a box here at the bottom of the slide that says while the
`two of the three patents talk about a dose dial sleeve or a dose dial grip, one
`of them talks about it as a dose knob, the ’486 for example.
`One of them talks -- two of them talk about a drive sleeve, one talks
`about it as a driver but we are kind of using them all as the patents did in
`very much the same vein.
`And so if we look at the other or the bucket, we have got the ’008
`patent and the reason I put that in a different bucket, notwithstanding the
`similarity of many of the claim terms is because it rides off of a different
`chain from the original Great Britain application that was filed.
`The Specification includes two additional embodiments along with the
`one from the other cases and some additional text but as you can see from
`looking at the claim terms here, again, we are all in the same vein. There
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`isn’t all that much difference in the way that the patentee chose to claim
`these.
`Before I get into sort of the merits of some of the arguments, I’d just
`like to talk about some of my observations when I was, as I was going
`through the file recently.
`You know, I see some themes here. I think what we hear a lot from
`Sanofi based upon their slide deck and the papers that have been filed is a
`real fundamental effort to parse references in a very narrow way.
`So for example, when you see the -- Sanofi’s slide deck about
`Steenfeldt-Jensen for example, you’ll see that it’s not about Steenfeldt-
`Jenson. It’s about Steenfeldt-Jenson’s fifth embodiment or there will be
`discussions of Steenfeldt-Jensen’s second embodiment.
`It’s almost as if Sanofi has tried to take reference, the four corners and
`parse it out and carve it up into multiple sub references. And there is an
`effort by Sanofi repeatedly here to try to narrow those disclosures such that a
`person of skill in the art wouldn’t appreciate the reference as a whole but
`rather winnow in just on that particular embodiment. And as we cited in our
`parts under the BF Goodrich case, that’s 72 F 3rd, 1577, that’s just
`inappropriate and an invitation to create error.
`In addition, I think that most of Sanofi’s argument is terms of
`assessing the teachings of the reference or the modifications that Mr.
`Leinsing proposes are really filtered through a myopic focus on injection
`force. And so I think again that’s inappropriate.
`Dr. Slocum puts injection force far above as the defining
`characteristic of what would motivate a person of skill in the art and what
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`would dissuade that person of ordinary skill in the art from following clear
`teachings in the references themselves.
`JUDGE JUNG: But, Mr. Carsten, you don’t --
`MR. CARSTEN: Yes.
`JUDGE JUNG: You don’t disagree that a low injection force was one
`of the aims of the prior art?
`MR. CARSTEN: I do not agree -- I do not disagree with that at all.
`That certainly is one of the factors Mr. Leinsing frankly and candidly
`admitted that. But that’s not the end of the story.
`We are here talking in practice, not in the claim terms but in practice
`about disposable pens and these pens happen to be used in diabetic patients
`so these pens there are other factors that go along with it. Ergonomic factors
`for example beyond just injection force.
`There is a cost of making the pens, so reducing the number of
`components, create -- increasing the ease of manufacturability. There are all
`sorts of design goals that a person of skill in the art would consider and
`would understand that there is a tradeoff.
`Dr. Slocum I think inappropriately suggests that any change that
`would result in any increase in injection force would be a non-starter right
`out of the gate and therefore would be dissuaded from pursuing anything
`that could, that might increase injection force. And I think that’s just
`implying the wrong standard frankly.
`And then when we get to the analysis of the modifications, you know,
`Dr. Slocum, and we will get to some detail about the relative balance of the
`experts towards the end of the opening here but he really did just rely
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`entirely on one of the named inventors to populate his spreadsheet, to really
`inform his analysis.
`And to his credit, he admitted that forthrightly. He said right up front
`I have no expertise in this. I have no experience with injector pens.
`Professionally he had never held an injector pen in his hand before Sanofi
`engaged him for these IPR matters for the district court case.
`So, you know, I think that because of that, he was in a position where
`he had to rely upon an inventor and that inventor unfortunately comes with
`the biases and the predilections of an inventor to preserve and protect his
`patents.
`And by just whole cloth adopting what Mr. Veasey, the named
`inventor told him to adopt, that’s where we have an issue. So I think with
`those themes in mind, why don’t we jump in and I would just start --
`JUDGE JUNG: Before you get into your particulars, it appears to me
`that there is no real dispute about the level of ordinary skill in the art.
`Would you agree with patent owner’s statement that any differences in the
`two parties’ opposing proposals of the level of ordinary skill in the art would
`make no difference in our analysis?
`MR. CARSTEN: I think as applied here, I don’t think it really
`matters. In fact, I think if I’m not mistaken, each of the experts at their
`respective depositions and when I say the experts, I’m talking about Dr.
`Slocum and Mr. Leinsing said that my opinions wouldn’t change if I applied
`the other side’s level of ordinary skill. So in practice, I don’t think there is a
`difference.
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`
`JUDGE JUNG: Would your arguments be affected if we used the
`references as a point of -- as an indication of the level of ordinary skill in the
`art?
`
`MR. CARSTEN: No, I don’t believe so at all. I think that the
`references, I think really do reflect the notion of a person of skill in the art
`that they would be motivated well beyond just a simple adherence to a
`myopic injection force. I think that they all discuss among other things, the
`ergonomic and manufacturability of reducing components, a number of them
`do.
`
`JUDGE JUNG: And finally, in some of these proceedings, the
`meaning of tubular clutch, whether it’s actually a means-plus-function
`limitation was in dispute, but it seems like at this point, we don’t have to
`decide whether a tubular clutch is actually a means-plus-function limitation
`to decide the unpatentability or patentability of these claims, of these
`challenged claims.
`MR. CARSTEN: I think that’s absolutely right. I mean, I think that
`well, you know our view on that. They are means plus function in certain
`circumstances, certain cases they are means plus function. But I think in
`terms of the obviousness analysis, I don’t think it matters all that much.
`JUDGE JUNG: Okay. Thank you.
`MR. CARSTEN: So I’d like to start with the Burroughs reference if
`we might. So if I could go to slide 12 please. So Burroughs renders the
`claims obvious. I have got a number of claim elements here which aren’t
`really in dispute in terms of what Burroughs teaches.
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`
`I think the real gravamen of the dispute here is whether a, the rib can
`be swapped with a groove, that modification. And so when you look at the
`Burroughs reference, you’ll see if we go to slide 13 that there is a clear
`statement or a clear description of swapping the interchangeable in this
`predictable art rib or a groove.
`JUDGE JUNG: All right, Mr. Carsten, before you go on, there seems
`to be some dispute about what exactly is your modification. So can you
`describe what exactly you’re proposing to modify Burroughs? How are you
`going to swap the rib and groove?
`MR. CARSTEN: So the modification is, has been clear across the
`board. There is one universal Leinsing declaration that applies in all these
`cases and so I understand that there has been some objection to these slides
`so let me address that right off the bat.
`I think that the modification that Mr. Leinsing identified and let me
`just pull that up directly on the next slide, slide 14. Mr. Leinsing in his
`omnibus declaration said here its paragraph 170.
`Specifically, a person of ordinary skill in the art would have
`understood that rotational operability between the components would be
`retained if the threads 110, 112 of the dial mechanism were configured as
`two parallel ribs that form a discontinuous helical groove for engaging the
`housing threads.
`So that the modification that Mr. Leinsing has been talking about all
`along. That is the modification that we have been addressing in connection
`with our petitions all along so there has been no change. There is no new
`argument. That is the modification.
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`
`You have an existing rib query and I think Mr. Leinsing in his
`deposition said well there is automatically going to be a groove next to a rib
`anyway. But to make it abundantly clear, the modification that he proposes
`consistent with the art is to add a second rib adjacent or essentially adjacent
`to it and he has identified where in his deposition upon questioning and that
`forms the groove. The rib, the thread appears on the outside of the seal, on
`the other side.
`So that’s the modification we are talking about and that’s the
`modification, excuse me, that we have been talking about since day one in
`the petitions across the board.
`JUDGE JUNG: Okay.
`MR. CARSTEN: And so going back to slide 13 if I might. You see
`in the, on the top here we have got Figure 7 from Burroughs and there is a,
`one of the ribs is identified in green.
`At his deposition, Mr. Leinsing was asked by counsel what do you
`propose -- where do you propose putting that other rib? And so he
`identified, he drew with a red marker and that’s the Figure 7 at the bottom of
`the slide where that would be.
`He was asked why? Well, that’s a predictable variation, if we go to
`slide 14, that a person of skill in the art would have expected that such a
`helical groove would engage into and disengage from the housing’s
`threading in exactly or substantially the same manner as the helical rib
`disclosed in Burroughs that retaining the dial mechanisms operability in a
`general sense.
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`
`It’s not a newly constructed made from whole cloth modification.
`This is simply mirroring taking a rib, moving it to the other side and
`replacing it and forming a groove. That’s the only modification that we are
`talking about here.
`And so if we go to slide 15, you know, what is Sanofi’s response?
`Well, you know, Sanofi said well, yeah, a person might have or could have
`performed the proposed modification but, you know, they don’t think a
`person would have.
`But we are talking about implementing a predictable variation and
`this, I’m going to say this. If a person of ordinary skill in the art can
`implement a predictable variation, Section 103 likely bars its patentability.
`Now those words come not from me, although I’m channeling them,
`those come directly from the Supreme Court in KSR. And rib to groove and
`groove to rib engagements were absolutely known and interchangeable in
`the art and that’s what Mr. Leinsing testified to.
`If we go to the next slide. So what do they do? Well, Sanofi kind of
`builds a strawman here a bit. They take that question response from Mr.
`Leinsing and they say well, all right. You identified where, now we are
`going to take a look and let’s go to slide 17.
`We are going to take that response to that question, your response
`identifying where you’d put the rib and we are going to apply exactly the
`same rib in a spot that we think approximates where you said it would be.
`We are going to make no other modifications. Our hands are tied.
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`
`And now we are going to apply an FEA analysis to that even though
`you never said that your second rib was going to be identically structured,
`identically sized, none of that. But that’s the analysis.
`It’s as if Dr. Slocum took Mr. Leinsing’s proposal and said okay, if
`I’m going to design this in a way because I know that these ribs have to get
`deflected in order for the device to operate, if I am going to set this up such
`that it designed to fail and make no other modifications, turn off my brain as
`a person of skill in the art and make that person of skill in the art a robot, an
`automaton, then I’m going to now prove that the thing I’ve just said was
`designed to fail actually fails. That’s not the legal standard here. May I
`have slide 18 please?
`JUDGE GERSTENBLITH: Counsel --
`MR. CARSTEN: Yes.
`JUDGE GERSTENBLITH: What would this newly created groove
`engage?
`MR. CARSTEN: I’m sorry.
`JUDGE GERSTENBLITH: What would the newly created groove
`engage?
`MR. CARSTEN: It would engage a rib on the opposite side on the
`hou..., on the inside of the housing that marries and mirrors that groove. So
`essentially you’ve got in the nascent design, you’ve got a rib on the drum if
`you’ll have it and then a groove on the inside of the housing that rides along.
`And now due to this modification, you’re merely swapping the two.
`So instead of a groove on the inside of the housing, you’ve got a rib and
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`instead of a rib on the drum, you’ve got a groove that marries with it and
`allows that device to be threaded upon dose setting.
`When it’s going to be injected, then you’ve got the button and the
`button pushes down. It deflects that, it deflects the groove out of the ribs
`away from the groove. In this case in the modification you’ll be deflecting
`that groove channel away and it allows it be injected.
`JUDGE GERSTENBLITH: So in reality, petitioner is not actually
`proposing to add a groove and a rib, you’re actually proposing to add two
`ribs, one to each of the components.
`So by adding a second rib where there already is one, you’re creating
`a groove, but you’re not adding a groove, you’re adding a rib. And now
`you’re adding a rib to the structure that previously had a groove. Is that
`what is happening?
`MR. CARSTEN: That’s essentially correct, yes. So we are adding
`the rib to define a groove, to define a channel upon which you could ride
`that rib along exactly the way that it was described in the Burroughs
`reference to begin with. There is a rib that rides along a groove. The rib
`happens to be on the other component.
`JUDGE GERSTENBLITH: Now the groove, the way Burroughs is
`set up before modification, the groove is an indentation in the exterior
`surface of that component, correct?
`MR. CARSTEN: I believe that’s correct.
`JUDGE GERSTENBLITH: And so the way post modification
`petitioner’s proposed groove would exist is not an indentation in the exterior
`surface because the groove fully sits let’s say laterally above the surface.
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`
`In other words, it is not into the exterior surface, it is only there
`because there are two ribs.
`MR. CARSTEN: It’s a defined -- maybe I can get it this way. It’s a
`defined channel that is defined by two ribs next to each other. So yes, if you
`want to say it’s not a channel in the outer surface if you’re talking about the
`broad radially -- radial surface, I think that they would be correct.
`But it would be if you define the radial surface as the other part, if we
`could go back to -- put up I guess 17. If you define the outer surface as
`being along the tops of those two ribs if you’ll have it, then it would be a U-
`shaped carve out into those two, between those two ribs, defining those two
`ribs.
`
`JUDGE GERSTENBLITH: But with that in mind, it’s not that
`petitioner is proposing a reverse -- just swap the components from one to the
`other, in other words, take what’s already there and just swap which sides
`the groove and the thread, the rib are on and it operates the same. That is not
`exactly what’s happening.
`MR. CARSTEN: Well, that’s what -- this is the way in which Mr.
`Leinsing identified it in his petition but just because we are identifying one
`way, you could easily imagine doing exactly what you’re saying, Your
`Honor.
`You could easily imagine instead of having the extended rib, you
`could -- taking an extended rib and adding a second one, you could easily
`imagine carving in and then putting a rib on the side of the inner housing.
`That’s another way in which you might do that.
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`
`That’s not the way that Mr. Leinsing in his declaration and in the
`petition proposed doing it. But just because there is one obvious way,
`doesn’t mean that there isn’t another obvious way.
`JUDGE GERSTENBLITH: Thank you.
`MR. CARSTEN: So let’s go to slide 18 please. And here we get
`back to -- so where is slide 18. Here we get back to another of the themes
`that I think we see and that is that, you know, here we have got a clear
`indication of Dr. Slocum taking, you know, a response to a question about
`where the second rib would be and turning it into essentially a schematic in
`which the person of skill in the art behaves as a robot and merely duplicates
`exactly the rib without any idea or notion about moving that up distally if
`that’s a problem or taking care to make sure that it’s a clever and reasoned
`approach.
`He simply takes the thing that Mr. Leinsing said here is where you
`might consider doing it and says that’s gospel truth and I can’t do anything
`but I’m going to just duplicate that right -- that rib and then perform an FEA
`analysis. That’s just not the way the people of ordinary skill in the art
`especially in these predictable arts operate.
`If we could have slide 19. And even if we were to say okay, we are
`going to handcuff the person of skill in the art. We are going to make them
`unable to apply their standard level of care in making sure that the things
`that they design actually are operable. They say there is a 10 percent
`increase in width. And they say well that’s bad, you wouldn’t do that.
`But Dr. Biggs testified that, you know, width is not necessarily a
`disadvantage here. If you have got these patients, these diabetic patients
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`who have some infirmity, having a larger girth could well be an advantage.
`And there is a statement from Dr. Slocum that there is an alleged 15 percent
`increase in injection force.
`Again, we come back to another of the themes that, you know,
`anytime there is a suspected injection force you wouldn’t do it. But that’s
`entirely speculative. There is no spreadsheet, there is no support for that.
`And even if there were a 15 percent increase in the injection force,
`there is no statement that that’s problematic. You know, 15 percent of a
`small number is still a small number.
`And Dr. Slocum is unable to put a number and say look, here is the
`threshold. He came up with 15 to 20 Newtons at his deposition but where
`that came from who knows.
`Unless there other questions on Burroughs, I’ll switch gears to
`Steenfeldt-Jensen. If I could go to slide 25 please.
`JUDGE JUNG: I just wanted to explore your argument about some of
`these matters just being a routine skill in the art issue. So at what point does
`one of ordinary skill in the art think an increase in size is too large?
`MR. CARSTEN: I don’t know that I have a good answer for you in
`terms of an absolute percentage. I think it depends in large part upon where
`you start from and that’s going to be variable. Obviously something that
`doesn’t fit in the hand, something that’s, you know, six inches wide or
`something wouldn’t be desirable.
`But again, it all goes back to this being a tradeoff and the design
`engineer thinking through okay, look if I want to increase the stroke length,
`do I want to have a fatter barrel, do I want to have a thinner barrel? Does
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`increasing the stroke length does that increase the injection force? If it does,
`that’s not necessarily a problem but by how much?
`And so it really becomes a balance of all of these various design
`factors that goes into the analysis that goes into the fundamentals of the
`design and that’s the one thing that Dr. Slocum couldn’t bring to the table
`and absolutely didn’t bring to the table in terms of his assessment to Mr.
`Leinsing’s proposals.
`JUDGE JUNG: Okay. And one last question.
`MR. CARSTEN: Sure.
`JUDGE JUNG: You do agree that if this modification created
`problems with jamming or misalignment of the rib and groove or problems
`with the flexibility of the rib, those are all factors that would play into
`whether or not the modification would be made in the first place, correct?
`MR. CARSTEN: Certainly a person of skill in the art would evaluate
`their, based upon their knowledge whether or not the design made sense.
`And think about that in terms and in the factors that, it’s along the lines of
`the factors we are talking about.
`You know that’s a, injector pens -- Sanofi didn’t inject -- didn’t invent
`injector pens. They’ve been around for a long time. It’s a crowded field as
`we have seen in the course of these IPR matters.
`And so you’re not writing on a blank slate and you use -- you’re
`applying commonly used elements that people of skill in the art here are well
`aware of and understand that are predictable. So I agree with that. I agree
`with what you said, Your Honor.
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`Case IPR2018-01670 (Patent 8,679,069 B2)
`Cases IPR2018-01675 and IPR2018-01676 (Patent 8,603,044 B2)
`Cases IPR2018-01678 and IPR2019-00122 (Patent 8,992,486 B2)
`Case IPR2018-01684 (Patent 9,604,008 B2)
`
`
`I think it’s true that they would apply their thinking on things but
`that’s not a handcuff. It’s not to be used as if there is, you know, a scintilla
`of an increase in injection force that you’d expect, that you would stop and
`say oh, I don’t know what to do, I throw up my hands.
`In fact it’s a -- well, we will talk about this more in three weeks’ time
`but it’s a stark contrast between the way in which Dr. Slocum approaches
`the what a person of ordinary skill in the art is comfortable doing when he is
`reviewing and discussing the written description problems in terms of the
`patents at issue in the IPR, the ’844 for example versus, you know, the
`myopic focus on injection force and the oh, I don’t know what to do, this
`wouldn’t work when he has tried to implement Mr. Leinsing’s. But that’s I
`think fodder for another day.
`JUDGE GERSTENBLITH: Just a question about the tubular clutch --
`MR. CARSTEN: Yes.
`JUDGE GERSTENBLITH: -- and the construction for that. So I
`know we spoke about that just earlier a little b