Trials@uspto.gov
`571-272-7822
`
` Paper No. 78
`
`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.
`
`
`571-272-7822
`
` Paper No. 78
`
`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. 76
`
`
`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
`
`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
`26
`
`3
`
`
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`4
`
`
`
`
`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
`
`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
`
`5
`
`
`
`
`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
`
`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
`
`6
`
`
`
`
`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
`
`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
`
`7
`
`
`
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`8
`
`
`
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`9
`
`
`
`
`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.
`
`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
`
`10
`
`
`
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`11
`
`
`
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`12
`
`
`
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`13
`
`
`
`
`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.
`
`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
`
`14
`
`
`
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`15
`
`
`
`
`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
`
`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
`
`16
`
`
`
`
`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
`
`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
`
`17
`
`
`
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`18
`
`
`
`
`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
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
