Trials@uspto.gov
`571-272-7822
`
` Paper No. 104
`
`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 IPR2018-01679 (Patent 8,992,486 B2)
`Cases IPR2018-01680 and IPR2018-01682 (Patent 9,526,844 B2)1
`____________
`
`Record of Oral Hearing
`Held: February 5, 2020
`____________
`
`Before 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 IPR2019-00981, IPR2019-01022, and IPR2019-01023, has been
`joined as a petitioner in these proceedings.
`
`

`

`Case IPR2018-01679 (Patent 8,992,486 B2)
`Cases IPR2018-01680 and IPR2018-01682 (Patent 9,526,844 B2)
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`
`DOUGLAS A. CARSTEN, ESQUIRE
`WESLEY E. DERRYBERRY, ESQUIRE
`RICHARD TORCZON, ESQUIRE
`Wilson, Sonsini, Goodrich & Rosati
`12235 El Camino Real
`San Diego, California 92130
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`
`ANISH DESAI, ESQUIRE
`SUTTON ANSLEY, ESQUIRE
`Weil, Gotshal & Manges, LLP
`767 Fifth Avenue
`New York, New York 10153
`
`W. KARL RENNER, ESQUIRE
`JOHN S. GOETZ, ESQUIRE
`Fish & Richardson
`1000 Maine Street, S.W.
`Washington, D.C. 20024
`
`
`
`The above-titled matter came on for hearing Wednesday, February 5,
`2020, at 10:00 a.m., at the U.S. Patent and Trademark Office, 600 Dulany
`Street, Alexandria, Virginia.
`
`
`
`
`
`2
`
`
`

`

`Case IPR2018-01679 (Patent 8,992,486 B2)
`Cases IPR2018-01680 and IPR2018-01682 (Patent 9,526,844 B2)
`
`
`
`
`P R O C E E D I N G S
`THE USHER: All rise. Thank you.
`
`JUDGE JUNG: Good morning. Please be seated.
`
`All right. This is the oral hearing for three related cases, Petitioners
`
`Mylan and Pfizer challenge U.S. Patent No. 8,992,486 in IPR 2018-01679
`and U.S. Patent No. 9,526,844 in IPR 2018-01680 and IPR 2018-01682.
`
`Starting with Petitioner’s counsel followed by Patent Owner’s
`counsel, please state your names for the record.
`
`MR. CARSTEN: Good morning. My name is Doug Carsten of
`Wilson Sonsini for Mylan. I’ll be arguing today. Along with me is Rick
`Torczon. He’s our lead counsel, also Wilson Sonsini. With me at table is
`Wes Derryberry also of my office and Tasha Thomas of my office as well.
`On behalf of Pfizer, Jovial Wong is here to listen to this trial.
`
`MR. WONG: Hello, Your Honor.
`
`JUDGE JUNG: Thank you. Welcome to all.
`
`MR. DESAI: Good morning, Your Honors. Anish Desai here for
`Patent Owner. Along with me is Sutton Ansley from Weil Gotshal and then
`John Goetz and Paul Renner from Fish & Richardson.
`
`JUDGE JUNG: Welcome, gentlemen.
`
`As we stated in our trial hearing order, each party has 135 minutes of
`total time to present its arguments. Each side may reserve up to 45 minutes
`for rebuttal. Also in our order we asked the parties to come up with a joint
`proposal as to how they want to present argument. Mr. Carsten, I’ll start
`with you. Do you have -- did the parties reach a joint proposal?
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
`
`MR. CARSTEN: I don’t believe we technically discussed it. We
`
`actually thought, based upon our reading of the panel’s order, that, you
`know, having the 90 minutes up front and then the break for an hour or so
`and then 45 minutes at the end, if there’s any mop-up, I -- we thought would
`work well.
`
`JUDGE JUNG: Okay. So --
`
`MR. CARSTEN: Yeah.
`
`JUDGE JUNG: -- for Petitioners, would they prefer 90 minutes for
`each side and then 45 minutes after a break for each side as well?
`
`MR. CARSTEN: I believe that was what was in the order as the
`default absent some other conversation and we thought that seemed to work
`well for us.
`
`JUDGE JUNG: Okay.
`
`And, Mr. Desai, any comments?
`
`MR. DESAI: I mean, that’s fine. I don’t know if Your Honors prefer
`if we just proceeded through the petition grounds first, dealt with that, do the
`back and forth on that and then deal with the motion to amend. I mean, that
`might be a more orderly way of handling it.
`
`JUDGE JUNG: I don’t know. Let me see. I don’t want to tell you
`how to present your arguments, but if you’re prepared to present the
`petition’s arguments first or deal with the petition’s arguments first and then
`the motion to amend, that’s fine with the panel. Likewise, Mr. Carsten, if
`you would rather somehow break up the arguments by IPRs or by patents,
`that also -- that’s fine with us as well.
`
`MR. CARSTEN: Well --
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
`
`JUDGE JUNG: As long as it’s clear that you’re arguing one
`
`particular set of claims and it’s clear to the panel that you’re arguing, for
`example, the ’486 Patent or the ’844 Patent.
`
`MR. CARSTEN: We’ve endeavored to break out the slides that we
`submitted to Your Honors in exactly that way. It’s pretty -- it should be
`pretty clear and apparent from the tenor of the slides what IPR we’re in and
`which claims go within those arguments.
`
`JUDGE JUNG: Okay. Thank you, Mr. Carsten.
`
`Thank you, Mr. Desai.
`
`MR. DESAI: So then I understand that Petitioner will do its entire
`presentation on all of the issues and then we’ll respond on all the issues and
`then rebuttal for both?
`
`JUDGE JUNG: Yes.
`
`MR. DESAI: Okay.
`
`JUDGE JUNG: All right. Let’s see. Two reminders. Please refer to
`your slides -- I mean, your demonstratives by slide number and don’t
`interrupt to make an objection. All that said, I’ll set up the clock with 90
`minutes for Mr. Carsten and then 90 minutes for Mr. Desai. And then we’ll
`take a one-hour break and come back for rebuttal.
`
`MR. CARSTEN: May I proceed?
`
`JUDGE JUNG: Yes, you may proceed when you’re ready.
`
`MR. CARSTEN: Good morning and may it please the Board. My
`name is Doug Carsten and I’m here on behalf of Mylan, the Petitioner in this
`matter. As I was preparing for this, we -- well, I just spent some quality time
`with you all three weeks ago, January 15. And so I’m going to endeavor
`today not to retread a lot of the ground that we’ve covered.
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
`
`There is -- there are some similar arguments here particularly with
`
`respect to Steenfeldt-Jensen. I have the slides, more or less, in the way in
`which they were presented in the last go-round. You know, I have some
`additional slides and some additional comments on that and I’ll make those,
`but I don’t want to waste your time and the parties’ times with respect to just
`rehashing exactly what we’ve talked about in the last hearing which was a
`mere three months, I believe so.
`
`In terms of preparing for this one, and we’re only talking now about
`two patents and three IPRs. 1679 for the ’786 and 1680 and 1682 with
`respect to the ’844. We just had a district court trial on the ’844 Patent, on
`four claims of the ’844 Patent and those are within the scope of the petition
`that we’re going to be addressing today.
`
`As I prepared for today, I came up -- what struck me were three sort
`of related points that -- I’ll call them themes, but, you know, I really saw a
`dichotomy, an interesting dichotomy, in the manner in which the Sanofi
`applied the level of ordinary skill in the art as a pure automaton without the
`ability to think and just really marry to the plain and direct language from
`prior art references in evaluating obviousness and yet, in contrast, this
`person of ordinary skill in the art had utmost flexibility and the ability to go
`out and prospect and be creative as people of ordinary skill in the art are
`when it came time for evaluating written description support for its own
`patent, specifically in ’844 and so that’s something I’m going to point out a
`number of times today.
`
`Similarly, you have the same situation that I noticed last time which
`was Sanofi is treating references as being collections of mini references not
`treating the four corners of the reference as a prior art reference, but rather
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
`
`saying, “Well, it’s the fifth embodiment or the first embodiment and it
`doesn’t -- the teachings of one don’t apply to the other,” whereas a person of
`skill in the art is obligated to read the references as a whole.
`
`Finally, I think in terms of the themes there really are a number of
`stark contradictions that we’ve seen over the course of the IPR and I think
`that some of this came up in connection with the motions to amend and
`some of the revised claim scope and some of the testimony from the experts
`about that revised claim scope really did contrast and, in places, outright
`contradict what Sanofi or their experts said in the first go-round here, so I’ll
`be pointing out some of those as well. And I think they’re all really of
`bearing in mind.
`
`So turning to -- I’ve got a group of slides here that just sort of lay the -
`- lay out the ground work for us. I’m going to skip through these quickly.
`Slide 3, for example, sets forth the 1680 and 1682 claims and grounds that
`were instituted. Slide 4 talks about the 1679 case which is the ’486 Patent
`and really what we’re going to be talking about there comes down, I think,
`to one limitation, specifically, you know, the -- in an interior of a flange, the
`axial extending T.
`
`But I’d like to start with sort of where I pick up the threads on where
`we left off last time. And so Slide 6, this is the independent claim, 21, from
`the ’844 Patent that’s at the heart of the 1680 and 1682 cases. And we’ve,
`again, been over this in some detail, so I am going to skip through a number
`of the slides that we’ve presented and I’m sure there’s a sigh of relief to --
`from the panel to hear that. I’m sure you didn’t really relish the notion of
`seeing 400 slides collectively submitted late last night, so I anticipate that
`I’ll be talking about these 400 slides or 200 slides today. I’m going to
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
`
`winnow that down and skip through. Much of this is here in the event we
`need it for rebuttal and so forth.
`
`Really, this is Steenfeldt-Jensen. We talked about this, probably at
`length, three weeks ago. At Slide 11, you know, these are the passages from
`Column 3 which Mr. Leinsing pointed to in saying, yes, you know, that
`really does teach a person of skill in the art to alter the position of the
`threads versus the flats and on Slide 12 we have Column 7 which is another
`example in the specification where a person of skill in the art is directed by
`Steenfeldt-Jensen to make that swap if you’ll have it.
`
`The reason I put these slides up even though we did cover them in
`some detail last time was the panel had a question for me last time. Sanofi
`had pointed out that Embodiment 1 differed in terms of dose setting, the
`mechanism for dose setting. And while, you know, the dose dispensing was
`similar, Sanofi tried to make the argument last time that this passage, the
`first sentence from the passage at Column 7 was directed to dose setting and
`therefore this second sentence about the other embodiments really would be
`thought to apply to the first embodiment only.
`
`And you would ask me, “Well, isn’t -- what do you make of that? I
`mean, aren’t they right that the first sentence applies only to dose setting?”
`And, you know, at the time I said, “No, I don’t think that’s right,” but I
`garbled an answer I think because you had just sort of -- I was -- I wanted to
`look at it with some care and in the intervening three weeks, I’ve had that
`opportunity.
`
`It says here, “In the shown embodiment, the End wall 4 with its
`threaded bore forms a nut member relative to which the piston rod is rotated
`by the piston rod guide and the driver tube 26.” In that situation with that
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
`
`language, the piston rod is being rotated by the piston rod guide and the
`driver tube. The only time in Steenfeldt-Jensen during -- that that happened
`is during dose dispensing not during dose setting and so that sentence
`absolutely is directed to dose dispensing and not dose setting.
`
`Moreover, the paragraph immediately above that passage at Column 7
`is directed to dose dispensing. So again, you know, I’ve had time to think
`on this a bit and I really did want to emphasize that this column is directed to
`the dose dispensing and those -- that dose dispensing mechanism, even
`according to their expert, Dr. Slocum, is the same between Embodiment 1
`and Embodiment 5.
`
`Turning to Slide 15. You know, here’s a contradiction. So Sanofi
`says no one on God’s green earth would think, because it’s stupid, or
`because a lawyer wrote it, or because they just would ignore it, that
`Steenfeldt-Jensen -- that a person of skill in the art would think that
`Steenfeldt-Jensen is telling them to swap those threads and flats. And yet
`here you have Dr. Slocum, and this is the first of several of the
`contradictions we’re going to see today, in his district court deposition,
`freely admitted that if you read the language, if you read the -- that sentence
`from Column 7 that we just looked at, you know, “And you don’t disagree
`that implementing what that word says involves flipping the slot and the
`thread, correct?” That’s what I asked him. Answer, “If you just read the
`words, you will flip them.” That’s clear as a bell. You flip them. That’s
`what the teaching is.
`
`If we go to Slide 16, please? This is from Claim 6. Now, Claim 6
`didn’t get an awful lot of play here, but in the district court in order to
`counter some of what Sanofi was saying and what Dr. Slocum was saying
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
`
`about there being no teaching of the flipped threads versus flats, I put Claim
`6 in front of him and said, “Look, look at this claim language. Said piston
`rod drive including a first part having internal thread meets the limitation of
`a driving member comprising a third thread, right?” “It could, yes.” “Well,
`it does, right?” Answer, “Yes, it does.” “Not it could. It does, right?”
`Answer, “That’s what it says.” So not only is the flip some hypothetical or a
`threaded driver member, some hypothetical, it is a claimed embodiment in
`Steenfeldt-Jensen.
`
`Slide 17? You know, this sort of goes to, as well, this notion of the
`distinction that Sanofi tries to draw and this is the testimony from Dr.
`Slocum that I referred to earlier about embodiments 1 and 5 of Steenfeldt-
`Jensen having very similar force chains and so forth during the dose
`dispensing mechanism. So, again, this distinction that Sanofi is trying to
`draw simply doesn’t hold water.
`
`Slide 18? You know, and then -- and we’ve got this spreadsheet and
`we spent a fair bit of time on the spreadsheet and the sources of information
`from the spreadsheet from Mr. Veasey, for example. You know, and it was
`presented as being an evaluation of the net effect of Mr. Leinsing’s supposed
`modification that is following the instruction of Steenfeldt-Jensen, but it was
`anything but and Dr. Slocum admitted that. If you -- it doesn’t account for
`the reduction in force that you’re going to see by taking the force off the
`pressure foot and he admits that here at Slide 18. It’s not met, at all.
`
`If we go to Slide 20, you know, here’s yet another collar friction
`analysis contradiction. So the spreadsheet that was initially prepared
`assumed that the entire collar -- so remember, when you do the swap as
`taught by Steenfeldt-Jensen, you take the force from being dissipated on the
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
`
`pressure foot into a collar against the driving member. And the spreadsheet
`assumed that the entire collar, that entire collar, rubs against the wall and he
`picked these numbers 9.4 and 5.7, which are fairly large numbers, in order to
`evaluate that.
`
`And it’s clear that, you know, engineers understand that it really is the
`radius or the diameter of that collar surface that’s going to determine the
`scope or the magnitude of the friction that you’re experiencing and the more
`friction you experience, obviously the higher the supposed injection force.
`
`You know, but just recently in connection with attacking an
`obviousness position with respect to clicker version A and, in fact, maybe
`it’s best to go to Slide 34 first here. So here’s what Dr. Slocum said initially
`in his declaration at Exhibit 2107. You know, he’s talking about the flexures
`in the Steenfeldt-Jensen. He’s saying, “Well, they could get stuck or they
`could get pressed into the opening and they could break because of the size
`of this collar bearing.” Okay. But now contrast that with 2332, that’s the
`most recent declaration. And he says second, “A person of ordinary skill
`would think to increase the strength of the clicker material so it would
`withstand any added stress.”
`
`So one, all his concerns before, “Oh, yeah. A person of skill in the art
`would know how to grapple with that and even if increasing the strength of
`the clicker material weren’t enough to address it, then he goes on to say
`third, “A person of ordinary skill would add a small bearing shoulder to
`driver tube 85 to keep the stresses off of those pawl clicker arms.”
`
`Well, now let’s go back to Slide 20. I mean, that’s a stark contrast.
`So he’s preparing and proposing a parade of horribles that a person of skill
`in the art would not be able to address at all up front and that’s reflected in
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
`
`the spreadsheet. Now, however, when he’s faced with another obviousness
`position to attack that he said, “No, no, no. A person of skill in the art would
`know how to address all that and they would reduce the size of that collar.”
`Well, you can’t have it both ways.
`
`And, you know, I’ve mocked this up a little bit on Slide 21 just to
`show it, but, you know, on the left we’ve taken these dimensions -- 3.9 is the
`dimension of the piston rod based upon the spread sheet. 5.7 is the
`dimension of the collar-bearing surface from his original spreadsheet. 9.4 is
`the outer dimension of that collar-bearing surface from his spreadsheet and
`we just mock this up against the Steenfeldt-Jensen. Well, so -- that’s a big
`collar and of course you’re going to see that it’s going to affect the clicker
`there.
`
`But this is him when he’s trying to combat Mr. Leinsing on the
`obviousness position in the first instance. Now that he has an alternative
`goal in mind, I need to knock down another of Mr. Leinsing’s obviousness
`positions, I’m going to throw all that out and I’m going to say, “No, no, no,
`you would know how to do it. You would either bolster the size of those
`clicker arms to strengthen them or you would shrink the size of the collar.”
`
`I mean, this is a representation of a contradiction that they just can’t
`escape. It’s night and day.
`
`JUDGE GERSTENBLITH: Counsel --
`
`MR. CARSTEN: Now --
`
`JUDGE GERSTENBLITH: Counsel --
`
`MR. CARSTEN: Yes?
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
`
`JUDGE GERSTENBLITH: -- are you saying shrink the size of the
`
`collar that’s -- are you comparing that or saying it’s the same as adding the
`small bearing shoulder; is that what you’re --
`
`MR. CARSTEN: This is --
`
`
`JUDGE GERSTENBLITH: -- saying?
`
`MR. CARSTEN: We are talking here about the collar friction, the
`bearing shoulder. And what we know is that when you reduce the diameter
`of that collar bearing shoulder, you’re going to reduce the friction. The 51
`percent number that Dr. Slocum’s, Dr. Veasey -- Mr. Veasey, Dr. Slocum’s
`spreadsheet came up with. Before when we wanted that number to be as
`high as possible, he picked numbers that gave the left-hand image.
`
`Once he realized that there was another position that he needed to
`combat, he came up with the thing on the right. We don’t know exactly
`because he didn’t say what the outer dimension of that collar is that bears the
`friction now, but he says it’s small which is not what’s on the left and that
`number is going to be far reduced from the 51 percent because every
`engineer understands that it’s the radius of the effective collar is that is going
`to guide the magnitude of that friction.
`
`So when it serves Dr. Slocum and Sanofi’s purpose, he’s perfectly
`happy and content to defer to Mr. Veasey and say, “Oh, yes, this is exactly
`right. This is what a person of skill in the art would do.” But when it
`doesn’t serve him, when going -- taking an opposition position serves him,
`he then shifts gears and comes up with a vastly different approach and
`doesn’t even say how that affects his beginning opinions and it’s starkly
`contrasting.
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
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`That spreadsheet from the get-go was loaded against Mylan and
`
`loaded against Mr. Leinsing and we know why, because Dr. Slocum’s task
`in this project was simply to rebut Mr. Leinsing. That’s what he was told to
`do. He was told to rebut Mr. Leinsing and that’s what he did. He was a
`good foot solider.
`
`JUDGE TARTAL: Counsel, what do you mean by “loaded”? What
`was “loaded” about the spreadsheet? Are you saying that there was
`something that was intentionally misrepresented?
`
`MR. CARSTEN: Well, one, it was presented as being a net reduction
`in friction. We know that’s not right because he didn’t account for the
`reduction in the pressure foot force. He said that he tried to be conservative
`when it came time to evaluating the collar friction. We know that’s not right
`out of his own words. Come declaration 2332, he says that a person of skill
`in the art would be motivated not to use that large collar, but use a small
`collar. We also know that he just took Mr. Veasey at his word in terms of
`the coefficient of friction and picked a .1 coefficient of friction even though
`his own writings demonstrated that plastic sliding on plastic coefficients of
`friction could range from .1 to 05.
`
`The man just -- every -- at every opportunity -- you know, and for
`Sanofi to stand here in front of you three weeks ago and say, “This is a
`conservative spreadsheet that’s designed to give them the benefit of the
`doubt,” it is anything but.
`
`JUDGE GERSTENBLITH: And did Petitioner propose in its
`modifications to add a small bearing shoulder?
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
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`MR. CARSTEN: Yes, Mr. Leinsing did, in his reply declaration, say
`
`that, yes, of course, you would understand that and that there would be a
`small bearing shoulder that’s put in there.
`
`Turning to Slide 22, and this is from Mr. Leinsing’s district court
`cross-examination. You know, when you actually bear all this in mind,
`when you take account -- you know, when you take into account the
`reduction from the pressure foot relief, when you take into account the
`properly circumscribed collar friction, when you take into account the proper
`level of coefficient friction, Mr. Leinsing said it would be a wash.
`
`Let’s go to Slide 33. This didn’t -- this isn’t going to get as much play
`here, but, you know, there is notion that undergirds much of Dr. Slocum and
`Sanofi’s analysis when it comes to modifications and it’s really the
`preeminence of the importance, the sole factor, the sole driving factor
`motivating a person of skill being production of injection force and I think
`we talked about that a fair bit. We talked about paragraph 56 last time of Dr.
`Slocum’s original declaration and how all of the citations there are post-
`priority date citations and the few examples of references pre-priority date
`all just talk about ease use in a more general sense. They don’t say that a
`person of skill in the art would actually go ahead and just focus solely on the
`question of injection of force.
`
`And, you know, that’s borne out by the clinicians here. I mean, here’s
`Dr. Goland. Dr. Goland is their M.D. expert. “Dr. Goland, have any of your
`patients ever come to you and said, ‘Gee, doc. I really wish I had a pen with
`a low injection force’?” “No.” “Have you ever prescribed an insulin solely
`based on the pen?” “No.” We have consistent opinions from the clinicians
`on this that injection force wasn’t the driving force for patients. It was
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
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`overall ease of use. There were other factors that people of skill in the art
`such as referencing Steenfeldt-Jensen about reducing number of parts,
`there’s ease of manufacturer, cost of the device, all of those things get
`thrown into the hopper in terms of making (indiscernible).
`
`Let’s turn to 35. You know, and the proof’s really in the pudding
`here. So, you know, here’s a passage from Steenfeldt-Jensen and Steenfeldt-
`Jensen -- this is Column 1, lines 30 through 40. “You know, people of
`ordinary skill in the art understood that for these devices it really is
`fundamental screw-in nut physics, that by other dose setting devices, one of
`the elements, the nut or the piston rod is kept unrotatable and the other is
`allowed to rotate a set angle depending on the set dose wherein the piston
`rod is screwed a distance through the nut.” You can do it by turning the
`screw or you can do it by holding the screw and turning the nut, and people
`understood that.
`
`And, you know -- Slide 36 here. You know, there are
`contemporaneous examples here. These are prior art. This is Giambattista
`95 (indiscernible). You know, people were doing exactly this. This is not
`uncontroverted. This is not controversial at all. I mean, this is standard stuff
`that pen designers at the time were doing.
`
`So, you know, let’s shift gears just a little bit and touch on Claim 22.
`This is Slide 38. You know, piston rod has a circular cross-section. The
`claim really requires that a piston rod have a circular cross-section and it’s
`uncontroverted here. This is the piston rod from the second embodiment of
`Steenfeldt-Jensen. No, I’m sorry. The second embodiment. No, this is not
`the second embodiment. This is the fifth embodiment of Steenfeldt-Jensen
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`IPR2018-01679 (Patent 8,992,456 B2)
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`and it’s clear that there are multiple cross-sections and some of these are
`circular.
`
`Now, that Sanofi tries to do, and on the next slide, Slide 39, is to try to
`rewrite the claim to say, “Well, no, no, no. This claim means a circular
`cross-section along the entirety of the length,” but that’s inconsistent with
`being the broadest reasonable interpretation which is what we’re operating
`under here. And there’s no suggestion in the specification, no teaching, that
`the piston rod must be perfectly circular along its length. You know, the
`’844 Patent itself is -- Column 3, lines 58 through 66. “A first thread
`extends from a first end of a piston rod. The piston rod is of generally
`circular cross-section.”
`
`Well, it doesn’t say it’s perfectly circular throughout. It has to be
`entire length circular. In fact, it doesn’t even have to be circular. It says
`“generally circular”. That’s the way that the ’844 patent is talking about
`circularity in terms of the piston rod.
`
`JUDGE TARTAL: So if you return to Slide 38, counsel, is that
`generally circular in cross-section?
`
`MR. CARSTEN: Certainly there are circular cross-sections there and
`I would submit that it is generally circular. And I get to that result by virtue
`if we turn to page -- to Slide 42. This is from Sanofi’s Patent Owner
`response. They said, “A piston rod” -- rather, “The specification shows that
`the piston rod has a circular cross-section over its length because it is
`adapted to engage with and move rotationally and axially relative to the
`cylindrical bore in the drive sleeve.” That image that you just looked at,
`Judge Tartal, at 38 does exactly that function. It does “engage with and
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`move rotationally and axially relative to the cylindrical bore in the drive
`sleeve”. That’s what it’s designed to do.
`
`Now, it has additional features. It has flats which are adapted to
`engage in others, but in terms of being generally circular, yes, I think that is
`generally circular. And certainly even if you don’t want to go that far which
`you don’t need to here, you can simply look and say, “Okay. There’s a
`couple of uncontested areas where there is a generally circular cross-section.
`So let’s shift gears now, if we could unless there are questions about the
`Steenfeldt-Jensen, the 1682 IPR.
`
`Okay. Let’s shift gears to the 1680 IPR. And, again, thus far we’ve
`really just been talking about the original petition. I have dabbled in some
`things from the motion to amend, but we’ve been talking about the original
`claim set and the petition from 1682 and I’m going to continue that trend
`with 1680 now.
`
`Now, this one shouldn’t be all that controversial. This is the
`Giambattista and, you know, really what we’re talking about here, go to
`Slide 45, is the priority issue. I think that’s the front and center issue here.
`The ’844 Patent simply, these claims, are not entitled to the priority date
`back in 2003. There’s the claim language about internal or external threaded
`that appeared for the first time 13 years after 2003, the first time in this ’844
`Patent.
`
`And, you know, I’ve got some case law support here that really does
`demonstrate that, you know, obviousness isn’t enough for possession. This
`really does turn on the Ariad test. And under Ariad, you need to have either,
`for possession, an express teaching or you need to have blaze marks and
`guidance, and here we have nothing. And we’ve taken this position from
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`IPR2018-01679 (Patent 8,992,456 B2)
`IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2)
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`day one in our petition, “Show us the money,” we’ve said to Sanofi and
`repeatedly they’ve failed to do so. The only thing they’ve come up with is
`the word “threaded”. Okay. Well, so what. That’s a general teaching which
`Ariad actually says isn’t enough. It doesn’t get you there. A general
`teaching doesn’t give you the blaze marks or the guidance to show that y