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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`INTUITIVE SURGICAL, INC.,
`
`v.
`
`ETHICON LLC,
`_____________
`
`Case IPR2018-01703
`Patent 8,616,431 B2
`____________
`
`Record of Oral Hearing
`Held: October 17, 2019
`_____________
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`
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`Before JOSIAH C. COCKS, BENJAMIN D. M. WOOD, and
`MATTHEW S. MEYERS, Administrative Patent Judges.
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`Case IPR2018-01703
`Patent 8,616,431 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
`
`
`STEVEN KATZ, ESQ.
`ROGER A. DENNING, ESQ.
`RYAN O'CONNOR, ESQ.
`Fish & Richardson P.C.
`601 Lexington Avenue, 52nd Floor
`New York, NY 10022-4611
`212-765-5070
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`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`ANISH DESAI, ESQ.
`CHRISTOPHER PEPE, ESQ.
`CHRISTOPHER MARANDO, ESQ.
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153-0119
`212-310-8000
`
`
`
`
`The above-entitled matter came on for hearing on Thursday, October
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`17, 2019, commencing at 11:13 a.m., at the U.S. Patent and Trademark
`Office, 600 Dulany Street, Alexandria, VA.
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`Case IPR2018-01703
`Patent 8,616,431 B2
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`P R O C E E D I N G S
`- - - - -
` (Proceedings begin at 9:04 a.m.)
` JUDGE WOOD: This is the oral argument for IPR2018-
`01703. Under the hearing order, each side has been given 45
`minutes. We're running late, and we would request that each
`side limit their arguments to 40 minutes, if possible. If
`that's objectionable, please let us know; otherwise, we will
`go forward with the understanding that each side will have 40
`minutes rather than 45 minutes.
` Again, Petitioner will proceed with its case first
`and may reserve rebuttal time. Patent Owner will then proceed
`and may reserve sur-rebuttal time.
` So Petitioner may begin when ready.
` MR. KATZ: Thank you, Your Honor. I think we'll
`reserve 15, so about 25. We'll try to limit it to 25, and
`then reserve 15.
` JUDGE WOOD: All right. Thanks.
` MR. KATZ: All right. So what we need to do is to
`connect first.
` JUDGE WOOD: You may begin when ready.
` MR. KATZ: Okay.
` So if we go to Slide 2, I will start there, a
`summary of what we're going to talk about. This is the '431
`Patent, which is what we call the Shifter Patent, and the key
`issue here is whether the Whitman reference discloses a
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`robotic system or not, and there are some certain issues.
` So, first, we'll be discussing what it means to be a
`robotic system. And one thing we'll be pointing out is that
`Patent Owner's expert admitted that, in general, a robotic
`system is just a robot. We'll show you that. We'll then show
`how when it anticipates, specifically because it does disclose
`a robotic system, as that term should be properly construed.
` We'll also then be talking about Whitman in
`combination of Tierney; also clearly disclosed a robotic
`system because in that case, that Tierney is undeniably a
`robotic system. And so when you combine Whitman with the
`Tierney tool -- I mean, excuse me -- when you combine Tierney
`with the Whitman tool, you do then have the robotic system,
`but we do think the first two, robotic anticipation, and then
`we've got the obviousness argument.
` And finally, they make numerous arguments about
`motivation to combine, and we think there's a clear motivation
`to combine Tierney with Whitman.
` With that, we'll get started.
` On Slide 3, it shows really what's not in dispute
`here, but is the crux of our Petition, which is interesting.
`All right? We're going to be talking about some subsidiary
`issues here, but, fundamentally, the '431 Patent is about
`adding a shifter to a surgical instrument, and Whitman clearly
`discloses the shifter.
` Again, there's really no dispute about those points,
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`but I think just to anchor us, it's important to recognize
`what we're talking about.
` So Whitman has a shifter. You can move it into one
`of four positions, for rotation, articulation, or clamping,
`and firing. No dispute about that. What they argue is that
`Whitman doesn't qualify as a robotic system.
` So let's move on to Slide 4.
` So we have a question. What is a robotic system,
`and what it means to be a robot? And, fundamentally, and this
`is key, is the '431 Patent does not answer this question. All
`right? The '431 Patent presumes that the reader knows what a
`robotic system is, and there is no special and narrow meaning
`of a robotic system in the '431 Patent. It's applying the
`ordinary meaning. And critical here is Patent Owner's
`sur-reply, and this is a quote from it, "Contrary to
`Petitioner's assertion, Patent Owner does not 'ascribe a
`special and narrow meaning' to the term 'robotic system.'"
` All right. That's not their position. They're not
`saying there's some kind of lexicography going on because it's
`especially narrow. They're just saying kind of what it is.
` So they criticize -- let's go to the next slide,
`Slide 5. They criticize Petitioner and say, Well, they're not
`even relying on the specification of the definition. And with
`most terms in a patent or most terms in any document you might
`read, there aren't definitions. You have to go to the
`dictionary for definitions.
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` So if there's no special definition. Then the
`question is, Well, what is just a robotic system? Because the
`'431 Patent is using it in its ordinary way. And so Dr.
`Knodel did use what he thought was a pretty good definition
`for -- in the surgical context, where it says, A surgical
`robot is a self-powered computer-controlled device that can be
`programmed to aid in the positioning and manipulation of
`surgical instruments, enabling the surgeon to carry out more
`complex tasks.
` There may be other definitions, but that seemed like
`a useful one. It's not clear what's so objectionable about
`it. That does seem to describe what it might be to be a
`surgical robot.
` The other big question in this case is whether a
`robot can be handheld because Whitman is a handheld device.
`So if we go to Slide 6. So what Dr. Knodel did is he
`discussed five different references. Now, I believe these are
`all in the prior art. I believe they're prior art references,
`but I'll just say they're references because they don't
`necessarily have to be prior art, and I'm not 100 percent
`sure, so -- but he's cited five references least
`contemporaneous in the art showing that robots in the surgical
`field covered handheld robots. These are all handheld
`devices, and they are referred to as surgical robots, each and
`every one of them. Let me point to where Dr. Knodel cites
`these in, generally, Paragraphs 163 and 164 of his
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`declaration.
` And so what we say you can take away from that is
`the evidence shows that surgical robots' a generic term, and
`it can certainly include handheld devices. You don't exclude
`handheld devices.
` We then took the deposition of Patent Owner's expert
`Dr. Cimino. If you go to Slide 7? And we went around and
`round. We went -- you can read it. You've got a copy. It
`might make some entertaining reading. This was the final Q
`and A of a very long section. It seemed to me to last for
`hours, but maybe it was only about 20 minutes.
` And the question was, what does it mean to be a
`robotic system? And are you saying system means something
`specific? Are you tying it to robotic? Like, what are you
`talking about? And he would not answer the question without
`me adding the word outside of the '431 Patent because he kept
`saying, Well, in the '431 Patent, I think it has a specific
`meaning.
` And so I said, Okay, outside the '431 Patent, what
`does a robotic system mean? And there are a number of
`questions like that.
` And so, finally, you know, saying are you excluding
`handheld surgical robots described in these references,
`meaning the references cited on the prior slide, from the
`concept of robotic systems? Generally, outside of the '431
`Patent or in other words, set the '431 Patent aside, just, are
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`you excluding handheld robots from the meaning of robotic
`system? Then he says, Okay, and so just -- I think it's
`really -- and he says, the concept of a robotic system outside
`the '431 is just a robot.
` And so in other words, unless there's something
`special and narrow in the '431 Patent, it's going to give a
`narrow definition. He's saying in the surgical robotic field,
`which is the field of the '431 Patent, it just means a robot.
` So at one point, they do suggest there was some
`definitions in the patent, which seems to contradict their
`statement in their sur-reply, but I'm sure they'll address
`what they mean by that.
` If we go to Slide 8? All right. So they say, "Over
`the years a variety of minimally invasive robotic (or
`"telesurgical") systems have been developed." And they cite
`this passage on Slide 8 for the -- that they're defining
`robotic system to mean telesurgical.
` But first of all, they are not here today saying
`robotic system means telesurgical. One thing about a
`telesurgical system is it can be operated remotely. And I
`don't believe they're requiring, in their definition of a
`robotic system, that you must be operating remotely.
` JUDGE WOOD: When you say remotely, you mean like in
`a different room, different building, different --
` MR. KATZ: Traditionally, the notion of telesurgery
`is distant surgery, like different building, different city,
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`around the world. All right?
` When this technology was originally developed, the
`idea was it was for army use, right? So that surgeons could
`be safe and sound, and they wouldn't have to be like in a mash
`unit at the front lines.
` And so the question is how broad -- but I guess the
`key is they don't actually then go and define telesurgical.
`All right? So we don't quite know the full bounds of what
`this means.
` But our point is this is not a definition. This is
`simply a reference to prior technologies. And compare that to
`the definition, which we have right below it, "As used herein,
`the term 'loading orientation' means." And then they go on at
`length.
` Clearly, the Patent is defining loading orientation.
`We submit that's what a definition looks like, and to argue
`that the top thing -- the top statement about telesurgery is a
`definition is going too far.
` And, again, then that begs the question, what does
`telesurgical mean? And they don't try to define that. But my
`understanding of telesurgery is, if you look at the
`references, operating at a distance, tele.
` Go to the next slide. So then their next argument
`is that there's a definition here because it says that there's
`something called a robotic system 1000, which has two
`components, the master controller and the slave cart. And
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`again, this is an exemplary embodiment. It so happens, in
`this patent, there's no robotic system 2000 or robotic system
`3000. But as is typical in many patents, all right, once you
`put a number on something, you're talking about a specific
`thing in a specific figure, and that's not definitional of the
`term robotics system.
` I don't believe that anywhere else do they claim
`that every time they use a term and put a number on it, it's
`defining the generic term. That's just not how patents work.
` And, here, the language of collectively referred to
`is not a definition. It's a compilation. All right? They're
`saying, we have defined a master controller, one of -- one in
`this figure is being this thing, and we've said the slave
`cart, in this example, is 1101, 1100 is this thing. Oh, and
`we're going to say, together, we're going to call that robotic
`system 1000. But nowhere do they say every robotic system has
`to have those two components shown in those figures.
` And if we can go to Slide 10. We know this. All
`right? So the Patent Owner's definition is that a robotic
`system somehow must have a master controller and a robotic arm
`slave cart. So I asked Dr. Cimino, are you saying that if I
`have a system that I would argue is a robotic system, that
`would be robotic system in the art outside the '431 Patent,
`but it's bolted to the floor, it's not on a cart, are you
`saying that it's outside the term robotic system as used in
`the '431 Patent simply because there's no cart? And his
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`answer was, "I would not exclude it." And of course, he
`wouldn't.
` And so they have read cart into their definition,
`and it doesn't belong there. There is no requirement that a
`robotic system have a slave arm cart. And once you agree with
`that, then their definition has to go away. It's like you
`cannot read this one specific embodiment, which does disclose
`a cart. It's a cart -- was it -- it's -- the arm slave cart
`1100 is a cart, but that's not a requirement of the term
`robotic system.
` Okay. With that background, does Whitman disclose a
`robotic system? And we say it certainly does.
` So if we go to Slide 11, you have this tool, which
`does have a handle, and it's coupled to this controller box,
`which is, you know, somewhat remote, but in the same room, and
`the controller controls the operation of the end effector in
`the tool. And Dr. Knodel explains, as we show on Slide 11, in
`Paragraph 162, that this meets the definition of a robotic
`system, as -- you know, as he's using that term. And so --
`and certainly, we're on record as saying this does qualify as
`a robotic system. And it clearly is.
` And if we go to the next slide, 12, we kind of see
`why. So inside that controller box in the prior figure is all
`this stuff on the -- in the center of the page. You've got
`the controller. You've got all sorts of motors and other
`things.
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` And if you look at what we've circled in red on
`Slide 12, and this is referring to Figure 12 of Whitman,
`there's a wireless RCU, which is a remote-controller unit for
`use with Whitman.
` And if we go to Slide 13, we see a picture of the
`RCU. And one thing that this has, if you look in the upper
`left corner of this RCU, there's a steering controller 1300,
`which is a four-way rocker switch. All right?
` So this is like a remote control unit. You might
`think of it just like the rocker switches on your television
`or remote control. And it controls steering cables. And what
`do these steering cables do? And it's true. I had not been
`familiar with this sort of technology before, but the steering
`cables actually steer the instrument. You're coupled from the
`controller to the instrument, and it moves the instrument
`around, and I'm going to show you that their experts who
`admitted as much, shortly.
` But before we get there, let me get to the tool
`mounting portion because they also argue that Whitman doesn't
`disclose a tool mounting portion.
` If we go to Slide 14? Thank you, Ryan. All right.
` So Dr. -- and they -- I believe they make a
`statement that we have no evidence or support and don't argue,
`but we do. And so here is Dr. Knodel in Paragraph 171, and he
`says, you know, "The connection point is at the handle of the
`instrument and thus the handle is a 'tool mounting portion.'"
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`And then he says, "Whitman discusses steering cables through
`the flexible shaft, which would inform a POSITA that the
`flexible shaft has certain degree of rigidity so that it lends
`support to the surgical instrument."
` And so Patent Owner says, a tool mounting portion
`has to have some support. There's got to be a supporting
`structure. And we don't disagree that that's in the nature of
`mounted, so that's not in dispute here.
` Then what they say is -- and we never say, or argue,
`or have evidence that lends support, and Paragraph 171
`provides that; that the cables have to support the instrument
`because they have a certain degree of rigidity because,
`otherwise, you can't steer anything.
` And so on the -- some question, what does the
`steering cables do? And if we go to the next slide, 15, and I
`know there's a lot of text here. I apologize for that. This
`is testimony from Dr. Cimino.
` And so Dr. Cimino originally said, The steering
`cables are steering the end effector. But I think that the
`steering cable controls are kind of, I guess, just working the
`articulation, I would guess. And then he said, I want to make
`a correction. And he says, I'd like to make just a short
`correction, having read the paragraph. And it's about the
`steering cables. And he says, I think they call them steering
`cables, and they steer the flexible shaft north, south, east,
`and west, and that the operation of switches steers the
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`flexible shaft.
` And so he said, To the extent I was implying it was
`steering the end effector, that's wrong. It's actually
`steering the cable itself that's connecting to the handheld
`instrument.
` And I said, Okay, and does the cable, therefore,
`move the instrument? And he wouldn't answer that at first.
`And so, finally, I said, Well -- but could it move the
`instrument north, south, east, or west at it -- as it talks
`about, and he did admit it would probably cause it to perhaps
`pivot a little bit.
` Now, then he went on to say, I don't know, risky
`business. But the bottom line is even he had to admit, this
`Patent Owner's expert, that the -- what the steering cables do
`is cause pivoting of this instrument. So you can imagine --
` JUDGE WOOD: The instrument being the end effector?
` MR. KATZ: No, no. The instrument meaning the
`entire thing: the handle, the steering cables --
` Can we go back to the figure of the box and the
`unit?
` The steering cables connect the box to the bottom of
`that handle.
` JUDGE WOOD: All right.
` MR. KATZ: That's where the mounting is. So the
`steering cables are running through that long cable, and it is
`making the cable itself move, not the end effector. So what
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`it's moving is the back of the instrument, the bottom of that
`handle. It's got rigidity. The -- it discusses that it's --
`there's this rigidity to that connection, and that the
`steering cables cause the cable itself to move.
` And so that's why he admitted that there's some
`pivoting. So you can imagine, the surgeon is on the remote
`control, you have maybe a nurse or assistant holding the
`instrument up in -- you know, you put in the cannula, and then
`with the remote control, you can actually control where the
`instrument is moving in the cannula. So it's pushing and
`pulling the instrument.
` And so that's what he, at first, wouldn't admit, and
`he kept saying no, no, no; it's working the end effector. And
`then he admitted, No, I've got that all wrong; you're right.
`Whitman discloses that you're actually steering the cables
`that connect to the instrument, not steering the end effector.
` JUDGE COCKS: Well, I guess that begs the question,
`who's controlling the end effector in that scenario?
` MR. KATZ: The end effector is controlled by control
`cables that are run through the shaft. All right?
` The steering cables -- there's a shaft connecting
`the box to the instrument. It has steering cables that can
`tension and move the shaft. It also has control cables that
`control the instrument.
` And the control cables, there are two of them, and
`they control the shifter that we showed at the very beginning.
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`And so the shifter, you shift into position, and then you
`would drive it.
` And so in the shaft, it discloses you have both
`steering cables to steer the cable, and you also have the
`control cables that would control the end effector.
` And if we turn to the next slide, 16, just as a
`picture. So, here, we're showing Tierney, but let's ignore
`the Tierney piece at the bottom.
` All right. So you've got this coupling that is
`coupled to the bigger shaft, and that coupling has the control
`cables, but the steering cables don't go into the instrument.
`The instrument doesn't take the steering cables and put them
`anywhere. The steering cables control the flexible shaft
`itself that is connecting at the bottom where those blue
`arrows are connecting the instrument. That's where the
`flexible shaft connects.
` And so based on that, we say it meets the qualities
`of a robot, it has the tool mounting portion at the bottom
`because the flexible cables have this rigidity and can be
`steered, and their expert admits that it can kind of pivot it
`north, south, east, west. And, again, what he was talking
`about is the instrument itself is being pivoted. So you have
`to imagine, the instrument's turned side here, upside down,
`the shaft's going in, and you're pivoting the bottom of the
`instrument to control where in the cannula, what direction
`it's pointing.
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` Okay. So that's our anticipation argument; that
`Whitman meets the claims because it clearly has a robot and
`the tool mounting portion. And we say that should be good
`enough. There's anticipation.
` Then we have this second argument, which says, Okay,
`if in addition to that, you could combine Whitman with
`Tierney, that Whitman is a handheld device, and Tierney is a
`robot, and that Whitman and Tierney can be combined. And
`Tierney says you can combine all sorts of instruments and one
`thing, that was the staple and pliers, and Whitman applies
`staples.
` And so what we show here is that two of the discs of
`Tierney would be used to drive the shifter, and the other two
`could either be removed or used for other things.
` And we have -- we provide two options. And they're
`in our Petition, and our reply gives citations. They make the
`argument. We don't make these arguments in the Petition.
`That's just not correct. We do provide citations.
` And just let me go to Slide 17, where we'll have the
`first option.
` So you have two drives for -- drive four functions.
`And here, Dr. Knodel is saying, "In order to provide greater
`functions than drives, one of ordinary skill in the art would
`have turned to Whitman and would have understood how to
`incorporate the Whitman shifter into the surgical instrument
`usable in the Tierney robotic system."
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`Case IPR2018-01703
`Patent 8,616,431 B2
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` And, again, the coupling is quite straightforward.
`It's rotary motions from the Tierney adapter to drive rotary
`inputs on Whitman. The connection is quite straightforward.
`You're going to hear Patent Owner say it's quite complex, but
`as Dr. Knodel says, it's rotary to rotary, and POSITAs know
`how to make that connection.
` And then Dr. Knodel states, as shown on Slide 17,
`"With Whitman's transmission shifter, two rotary drive
`elements 119 can drive at least four different functions." So
`we clearly are disclosing the two to four combination.
` We also cite Knodel testimony -- if we go to Slide
`18? All right. Dr. Knodel says, Where two functions do not
`need to be performed at the same time, Whitman can be
`advantageous because it decreases the number of drives.
` And the bottom part is the one that they don't
`actually respond to. He says, "One benefit from using a
`shifter is that a user could not accidentally change the
`articulation during stapling because the articulation function
`would not be selected during stapling."
` So what he's saying is there's a benefit to having a
`shifter because you make sure you can only do one thing at a
`time. And that would apply even to their argument, where they
`are going to make the argument, get up here and say, Oh, well,
`Tierney has four discs; Whitman provides four functions. It's
`four-to-four; you don't need the shifter. And, Dr. Knodel
`says, Well, actually, you might still want a shifter because
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`Case IPR2018-01703
`Patent 8,616,431 B2
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`you may want to isolate the functions. You want to make sure
`you cannot fire at the same time you're articulating or
`probably you'd be articulating at the same time as you're
`firing.
` But the key is this gives a clear motivation to say
`it's not just reducing the number of functions. I may very
`well want to make sure that I'm using a shifter to make sure I
`cannot articulate while the firing is taking place. You can
`only do one thing at a time.
` So that's option one, saying where you're using a
`shifter to take Tierney's two drives, and you're driving four
`functions with it.
` If we go to Slide 19, we provide the alternate read
`where, on the other hand, you could say, Okay, use all of
`Tierney's four functions, four drives, and now, you can drive
`more than four functions. And say, Well, how is that
`possible? Where is that disclosed in Whitman? And it is
`disclosed because in the combination, what's interesting here
`is Tierney has four functions, Whitman has four functions, but
`they're different functions.
` So a POSITA might very well combine the two and want
`all the functions of Whitman and Tierney. And if you combine
`all the functions of Whitman and Tierney, you get six
`functions. They are rotation, clamping, cutting, stapling,
`that's four, and then articulation in Tierney is two-axis
`articulation, which requires two functions, five, six.
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`Patent 8,616,431 B2
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` So when you combine the two devices, if you want all
`the functionality that both teach, you need six functions; in
`which case, you would use Tierney's four discs to drive at
`least one Whitman shifter. And then, you've got two other
`discs that you could connect directly or connect to yet
`another version of the Whitman shifter, which is what we say,
`that's up to the POSITA to determine how they want to make
`that combination.
` Is there a question on that? Okay.
` So the motivation to combine, Slide 20.
` Slide 20 just puts the evidence where we have the
`motivation to combine.
` Could I also get a time check?
` JUDGE WOOD: You have a little over two minutes
`left.
` MR. KATZ: Oh, before the rebuttal time or two --
` JUDGE WOOD: Before you get into your rebuttal time.
` MR. KATZ: Okay. Thank you, Your Honors.
` So what we show in Slide 20 is where the evidence of
`motivation to combine is laid out. I'm not going to read it
`into the record.
` Slide 21, we talk about, additionally, testimony
`where, you know, Dr. Knodel at length -- because they say Dr.
`Knodel doesn't provide the arguments, so we summarized it
`there, and it's all there.
` One issue they do make, and I do want to make the
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`Case IPR2018-01703
`Patent 8,616,431 B2
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`point. They raised the point that, Well, where's the benefits
`of using a robot? Why would someone want to take Whitman and
`make it a robot? And we didn't think that would be a genuine
`question.
` And we do discuss benefits in the Petition, and Dr.
`Knodel does, but even Dr. Cimino on Slide 22 admits, you know,
`there are touted benefits of surgical robots, right? In the
`field, people knew that they offered benefits. One of them is
`increased precision of a surgeon's hand, right? I mean -- and
`so that's well-known; Dr. Cimino admitted it.
` With that, I'm going to save the rest of my time for
`rebuttal.
` JUDGE WOOD: All right. Thank you, Mr. Katz. You
`have 16 minutes for rebuttal.
` MR. KATZ: Thank you.
` JUDGE WOOD: You may begin when you're ready, Mr.
`Pepe. Do you want to reserve any surrebuttal time?
` MR. PEPE: Yes, Your Honor. I'll reserve five
`minutes for rebuttal.
` JUDGE WOOD: All right. So if you -- and I
`understand you don't object to 40 minutes? That'll give you
`35 minutes.
` MR. PEPE: We can make 40 minutes work.
` JUDGE WOOD: Okay.
` MR. PEPE: All right.
` So, Your Honors, first, I'm going to provide a brief
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`Case IPR2018-01703
`Patent 8,616,431 B2
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`overview of the '431 Patent, then I'm going to explain why
`Whitman does not anticipate any of the challenged claims.
`And, finally, I'm going to explain why the combination of
`Whitman and Tierney doesn't render obvious any of the
`challenged claims.
` The '431 Patent describes and claims a surgical tool
`for use with a robotic system. So what I'd like to focus the
`Board on is Slide 3, which is an excerpt from the '431 Patent,
`which describes one of the novel features of the invention
`claimed. And it explains that there's a novel shifter
`arrangement that enables two different articulation actions to
`be powered from a single rotatable body portion of the robotic
`system.
` So what the '431 Patent describes and claims is a
`robotic instrument that can perform more functions or control
`motions than there are motors in a robotic system.
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