UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC INC.,
`Petitioner,
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`v.
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`MARK A. BARRY,
`Patent Owner.
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`Case IPR2015-00780 & IPR2015-00783
`Patent 7670358 & 7776072
`On Remand From The Court of Appeals for the Federal Circuit
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`Record of Oral Hearing On Remand
`Held: April 11, 2019
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`Before DONNA M. PRAISS, BRIAN J. McNAMARA, and JEREMY M.
`PLENZLER, Administrative Patent Judges.
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`MEDTRONIC INC.,
`Petitioner,
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`v.
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`MARK A. BARRY,
`Patent Owner.
`____________
`
`Case IPR2015-00780 & IPR2015-00783
`Patent 7670358 & 7776072
`On Remand From The Court of Appeals for the Federal Circuit
`____________
`
`Record of Oral Hearing On Remand
`Held: April 11, 2019
`____________
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`Before DONNA M. PRAISS, BRIAN J. McNAMARA, and JEREMY M.
`PLENZLER, Administrative Patent Judges.
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
`
`
`JEFF E. SCHWARTZ, ESQUIRE
`RYAN NORTH MILLER, ESQUIRE
`Fox Rothschild LLP
`The Executive Building
`1030 15th Street, N.W.
`Suite 380 East
`Washington, DC 20005
`
`
`ON BEHALF OF THE PATENT OWNER:
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`JOHN ALEMANNI, ESQUIRE
`ANDREW W. RINEHART, ESQUIRE
`Kilpatrick Townsend & Stockton LLP
`4208 Six Forks Road
`Suite 1400
`Raleigh, NC 27609
`
`
`
`The above-entitled matter came on for hearing on Thursday, April 11,
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`2019, commencing at 1:29 p.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
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`P R O C E D I N G S
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` JUDGE McNAMARA: All right. Good afternoon, everybody. This
`is the oral hearing in the remand of cases IPR 2015-00780, and -00783.
`How about beginning with Petitioner, would counsel like to introduce
`themselves.
`MR. SCHWARTZ: Yes, your Honor, my name is Jeff Schwartz for
`Medtronic the Petitioner. I'm joined by Ryan Miller. We are both from Fox
`Rothschild.
`We also have Chad Hansen in-house from Medtronic with us today.
`JUDGE McNAMARA: Thank you. And for Patent Owner.
`MR. ALEMANNI: Good afternoon, your Honor. My name is John
`Alemanni, on behalf of Patent Owner, Mark Barry.
`With me today are Mr. Andy Rinehart, Ms. Anita Gray, who will be
`helping us with the slides. And we also have Dr. Leland Black and Ms.
`Kasey Koballa from our firm.
`JUDGE McNAMARA: All right. Well, thank you very much.
`Welcome to the Patent Trial and Appeal Board. Although this is a remand,
`we will approach this with the burden of proof on the Petitioner, so the
`Petitioner will go first, present its case on all of the applicable issues, any
`pending motions, and then the -- absent any special circumstances you can
`reserve no more than half of your time for rebuttal.
`The Patent Owner will then argue their case in opposition. Petitioner
`can then present his rebuttal if the Patent Owner so chooses to reserve some
`time for a brief surrebuttal, we will accommodate that as well.
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`Let me see, is there anything else I need to do in the beginning? Oh,
`just mention that this is a consolidated hearing again, so is everybody ready
`to begin.
`MR. SCHWARTZ: Yes, your Honor.
`JUDGE McNAMARA: Let's proceed.
`Oh, one thing I did forget to mention is that Judges Praiss and
`Plenzler are remote. So I do want to remind everybody to please identify
`whatever slide that you might be using on your demonstrative by number so
`they can find it and to speak into the microphones.
`MR. SCHWARTZ: Yes, your Honor.
`JUDGE McNAMARA: Thanks again.
`MR. SCHWARTZ: Thank you, your Honor. Again, my name is Jeff
`Schwartz for the Petitioner Medtronic, and I do want to reserve the
`maximum amount of time for rebuttal, so 30 minutes.
`JUDGE McNAMARA: Okay.
`MR. SCHWARTZ: I know we've been here before, my intention is
`not to repeat what we discussed on the record at our last hearing, but rather
`to discuss just those items that are relevant to the remanded proceeding,
`which have to do with the printed publication status of the video and the
`slides, and also the previously not instituted grounds.
`There will be a small amount of overlap, but my intention is to not
`restate things that we have already stated on the record.
`JUDGE McNAMARA: Okay, thank you.
`MR. SCHWARTZ: With that I would like to move to Slide No. 2,
`which is just a representative example of the claims at issue. It happens to
`be Claim 1 of the '358 Patent.
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`The -- this happens to be a method claim. Most of the claims at issue
`are method claims other than two of the claims from the '072 Patent.
`But I think the issues that are in dispute can be discussed through that
`vehicle. And my intention is only to discuss those claim elements that seem
`to have a dispute as to them, as opposed to, from the last hearing, where we
`went through every single element to show how it was in the art that we
`were referring to.
`So you can see as an initial matter, it's a method claim that deals with
`amelioration of aberrant spinal column deviation conditions. There is no
`specific amount of amelioration being called for, nor is there a specific type
`of condition that is called for.
`So the claims are not limited, for example, to scoliosis or to open
`procedures, or closed procedures, or minimally invasive procedures. Any
`procedure would apply to that preamble to the extent the preamble is even
`limited.
`The first element that we appear to have a dispute is the selecting
`element, which we've referred to in some of our papers as 1C, and in
`particular, the first group of pedicle screw engagement members that are
`mechanically linked. And the pedicle screw engagement members are
`essentially these metal tubes that attached to the heads of the pedicle screws
`that are themselves buried into the vertebrae.
`And the mechanical linking -- again, there is no particular type of
`linking required, so any linking would meet that limitation, particularly
`under the broadest reasonable interpretation standard which applies to this
`hearing.
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`The other element that we will be discussing is what we've referred to
`as 1F, or the applying manipulative force element, and in particular the
`requirement to apply force to the first handle means that connects the screw
`extensions, and thereby in a single motion simultaneously rotating said
`vertebra.
`And, again, there is no particular amount of rotation. You are going
`to hear from Dr. Barry certain things about amounts of rotation, or small
`amount or a large amount. The claim does not require any particular amount
`of rotation. And again, under the broadest reasonable interpretation of that
`claim, any rotation should suffice.
`So with that I would like to turn to Slide No. 4, which shows from the
`video from 2001 a couple of images. The bottom image I'm going to focus
`on, which is from Exhibit 1002, Volume 7, starting at the beginning.
`And before you start it, Ryan, the reason that we are talking about this
`here today is because this is the basis for the remand. Why does it matter
`that we are talking about the video. Well, in your Honor's final
`determination, you did not see in the chapter the actual motion that was
`being applied, the force that was being applied in a single motion to move
`both of the derotators and therefore the vertebra that they're attached to.
`And I apologize, your Honors, as to the extent that those that are not
`here can't see the video, but hopefully it hearkens back to your memories
`before.
`So, Ryan, if you can go ahead and start it.
`(Video played).
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`MR. SCHWARTZ: Okay, if you could stop there. And so what you
`saw as they said, apical derotor -- derotators are placed, to derotate the
`apical vertebra, thereby correcting the rib hump simultaneously as well.
`And what you see is Dr. Lenke's left hand. And what he is doing is in
`a single motion applying a force to those little rectangles on the top of the
`derotators, and in that single motion he is moving both of the derotators at
`the same time, they being rigidly attached to the vertebra, so the vertebra are
`also moving at the same time, which is the information that your Honors did
`not find present in the chapter and so why we are -- why they are so
`important that we discuss this.
`And you don't have to believe me on what you see in that video. You
`can trust your own eyes. And you can also listen to, on Slide 129, Dr.
`Yassir, who is Dr. Barry's expert.
`And Dr. Yassir, in Exhibit 1043, at Page 115, Lines 15 to 24, agreed
`that those derotators are moving at the same time, that they are attached to
`the vertebra, and when they move, the vertebra moves.
`So that meets the element, except we agree those derotators are not
`linked to each other. So that is the element that's missing from that slide --
`from that video.
`JUDGE McNAMARA: Let me ask a quick question just --
`MR. SCHWARTZ: Yes, your Honor.
`JUDGE McNAMARA: -- so the other judges and myself will be able
`to find this.
`The video is of record, right?
`MR. SCHWARTZ: Yes, your Honor.
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`JUDGE McNAMARA: So can you tell us where in the video we
`could find that so we don't have to watch the whole thing.
`MR. SCHWARTZ: Yes, your Honor. It's Volume 7 right at the
`beginning. It's about the first ten seconds or so. As indicated on Slide 4,
`Volume 7, right at the beginning for about the first ten seconds or so.
`JUDGE McNAMARA: When I look at the demonstrative at Volume
`7.01, it means that is one second into what's on Volume 7?
`MR. SCHWARTZ: Right at the very beginning, yes, your Honor.
`JUDGE McNAMARA: Thank you very much.
`MR. SCHWARTZ: Now, we are looking at Slide 48, for the purpose
`of discussing as an introduction, the linking element, which is missing from
`the video, admittedly.
`But what you see from these now instituted grounds is that the '349
`Patent, the '928 Application, and the '568 Patent all show the linking of
`screw extensions.
`In Exhibit 1005, Figure 2 from the '349 Patent, you see the screw
`extensions, and they are linked to a T-handle in a rigid frame to do various
`realignment and manipulations of that spine.
`Additionally, in the '928, and I know we talked about this quite a bit
`in the first hearing, Exhibit 1006 at Figure 11, you see the linked together
`screw extensions.
`And then, finally, in the '568 Patent, you have the outrigger members
`that are the screw extensions, and they are rigidly linked together by a lever,
`lever 20, to provide leverage to axially rotate and do other manipulations of
`the spine.
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`And Dr. Lenke opined about those references. Slide 51, Exhibit 1001,
`at Paragraph 82 of the '780 proceeding, Paragraph 89 in the '783 proceeding.
`And this paragraph was referenced numerous times in the petition for
`various grounds.
`And what Dr. Lenke is opining about is that the '349 Patent, the '568
`Patent, the '928 Application and the '328 Application all show mechanical
`linkage of screw extensions. And he explains that it is well-known in the art
`to link screw extensions. And why do they link screw extensions.
`Well, as you'll see, the '349 Patent, for example, explains that you link
`these screw extensions to provide a distribution of force to avoid breaking
`the pedicles on the vertebra.
`The '568 Patent explains that you are providing this rigid jack for a
`quick and straightforward manipulation of the spine, including to realign the
`spine, including for axial rotation.
`Those are the reasons why you link, and those are the reasons why
`you would link the Lenke derotators. Because it is well-known to link.
`And Slide 52 is just a continuation of the paragraph from Dr. Lenke's
`declaration and showing some of the examples of the images that he was
`referring to.
`And we know from Dr. Yassir, Dr. Barry's expert, Slide 64, Exhibit
`1043, Page 137, Lines 2 to 18, that Dr. Yassir agreed at his deposition that
`when you link the derotators together, they move at the same times, and
`that's common sense.
`If you link two things together and apply a force, they move at the
`same time. And if they are rigidly connected to the vertebra, the vertebra
`also move at the same time.
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`JUDGE McNAMARA: So -- so to make sure I understand what you
`are saying is that -- that the video that shows these three -- multiple ones of
`these columns that are attached to these pedicle screws, and then by this
`linkage which is not shown in the video would be disclosed by -- by what
`we are talking about here on Slide 51. And once they are linked, then they
`would all move at the same time.
`But the video doesn't show that. The video shows the possibility that
`those things could be individually manipulated.
`And so the question is, why wouldn't someone of ordinary skill want
`the ability to individually manipulate them instead of move them all at one
`time?
`MR. SCHWARTZ: Well, your Honor, I think -- I can't necessarily
`answer why you wouldn't want to manipulate them individually.
`But the point is that the prior art shows why you would want to
`connect them. You would want to connect them to distribute the force,
`which was a well-known motivation, as you will see not only in the '349
`Patent, but also in the Suk reference.
`In Exhibit 1031, Page 347, it talks about distributing the force to
`avoid breaking the pedicles. So that is the motivation to link. If there is a
`desire to not link, then you can just unlink them and move them
`individually.
`JUDGE McNAMARA: I'm not trying to turn the case on its head.
`All I'm trying to say is the motivation, as you put it, is to -- is to move them
`all at the same time to distribute the force. But there could be other factors
`where one wouldn't be motivated to do that if one wanted to have
`individual -- if one wanted to be able to manipulate them separately.
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`MR. SCHWARTZ: Yes, your Honor, and you could have multiple
`sets of them, some linked together and some not linked together.
`And as you saw in the chapter, there were multiple extensions on both
`sides of the vertebra. So there is even more of a desire in that situation to
`mechanically link them because you are extending your hand farther, you've
`got more things that you might want to connect. Or you might want to
`connect 3 out of 4, or 4 out of 5, or 3 and 3, or something like that. It gives
`you the ability to distribute or not distribute as you choose, as the surgeon
`chooses. Which is what many of these processes involve is sort of a, you
`know, an erector set where you decide which ones to link and which ones to
`not link.
`JUDGE McNAMARA: Okay. Thank you.
`MR. SCHWARTZ: So, your Honor, I'm going to move to Slide No.
`10, and we are going to talk about what the Federal Circuit said for purposes
`of this remand.
`Now, unfortunately, in our first proceeding, Dr. Barry conflated the
`meetings. There were three different meetings with some overlap in
`attendees, but largely a different group of attendees.
`You had the Arizona meeting that had 48 attendees. And then we had
`the St. Louis and the Colorado Springs meeting with an additional 75
`attendees. And those 75 attendees were not limited by the working group
`that attended the Arizona meeting.
`And, in fact, as you will see in the record, were open to the public to
`any interested member, any surgeon, or any other healthcare professional to
`attend.
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`And, of course, we know what happened, but the other thing that the
`Federal Circuit pointed out was that even if the Arizona meeting was
`exclusive, although we know from the record that it wasn't just SDSG
`members that attended, and that doesn't apply to St. Louis and Colorado.
`Even if they're exclusive, that's not the ended of the decision. You
`still have to look at whether or not the material was confidential, and
`whether or not there was an expectation that people might share that
`material.
`And what the record will show is that, in fact, the material was not
`confidential. We have eight sworn declarations on that -- people from
`Medtronic, some of the faculty and attendees of these meetings, and nothing
`on the other side.
`JUDGE McNAMARA: Actually, the confidentiality issue, was that
`even ever in dispute? I believe the final written decision said the meetings
`were not confidential.
`MR. SCHWARTZ: I don't believe there was a dispute as to
`confidentiality, your Honor.
`JUDGE McNAMARA: Okay.
`MR. SCHWARTZ: And, in addition, going to Slide 9, the Federal
`Circuit pointed out that the factors that you would consider are the size and
`nature of the meetings, whether they are open to the interested members, and
`whether there was an expectation of confidentiality. We have already talked
`about confidentiality.
`As to size and nature there were a 105 different attendees that
`received the video. There were 67 different attendees, because we've
`subtracted out the overlap that received the slides.
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`And when I say the slides, I mean the relevant slides, the slides that
`we have been referring to in the petition and in Dr. Lenke's declaration.
`So as to those slides, they were handed out to 67 people and 105 that
`received the video. So Slide No. 12, that's from our reply and sets out the
`numbers. But the point being, you got a meeting that's for educational
`purposes to tell physicians how to practice with the latest techniques. And
`then once they come home, they are expected to share that.
`And many of these attendees were at academic institutions. They had
`students, they had fellows, they had colleagues. And as the record will
`show, they went home and they would show that information to their
`fellows, to their students, to their colleagues, and they would put the binders
`on their bookshelf so that anyone that wanted them could get them. And in
`fact, we provided one of those binders, still on the bookshelf, for your
`Honors to see.
`So I am going to move on to Slide 14, which is Ashley Owens'
`declaration, Exhibit 1050 at Paragraph 2. And Ashley Owens, a Medtronic
`employee responsible for the St. Louis and the Colorado Springs meetings
`explains that they are medical education, open to anyone that was interested,
`any doctor or healthcare professional, and that anyone could find them.
`And we know that is true because Dr. Yassir, Dr. Barry's expert, when
`he was interested in this subject matter, he reached out to his Medtronic
`sales rep, and he was put into one of -- one of the meetings being offered --
`he said it was in 2003 -- and he was taught by Dr. Lenke about this subject
`matter.
`So we know it's true that people could find out about this if they were
`interested. And Ms. Owens on Slide 15 testified on her most recent
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`deposition, Page 15 and 30 of Exhibit 1051, that the purpose was to train and
`to educate.
`Slide 20, Ms. Owens at her Paragraph 4 further explained, since there
`seemed to be some confusion about that, that the St. Louis and the Colorado
`meetings were not limited to the SDSG group.
`Dr. Berven, one of the instructors at these meetings, Slide 16, Exhibit
`1052, Paragraph 4, explained that one of the expectations from this meeting
`was that doctors would further disseminate the material that they had.
`Slide 22, Dr. Berven, at Paragraph 8, explained that it was generally
`known and understood that Medtronic would provide the material to any
`doctor who asked for them.
`Dr. Berven, Slide 26, Paragraph 27, as I explained, he kept the binder
`from the St. Louis meeting on his bookshelf, and we provided an image of
`that. It still had the video in it. And it still had the slides in it. And we
`provided the entire copy of that binder to Dr. Barry in exchange for -- in
`response to their objection, which appears to have been dropped.
`And Slide No. 27, Dr. Berven explained that the material is not
`confidential and that he would go back every Monday after his meetings and
`share from those conferences what had been discussed.
`Slide 17. I am going to go through some of the other declarants a
`little more quickly. They say essentially the same thing. Dr. Polly, not to be
`confused with David Poley, at Exhibit 1053, discusses the further
`dissemination of the materials.
`Slide 28 Dr. Poley explains it's not confidential. He put the binder on
`a shelf.
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`Slide 18 Dr. Glassman explains that it's further disseminating the
`material. Slide 29 Dr. Glassman explaining it's not confidential, and he
`made the material accessible to his colleagues.
`Slide 30 Dr. Hanson putting the binder on his bookshelf telling his
`colleagues about it, discussing it after the meetings.
`Slide 31 Dr. McCarthy saying the material is not confidential and that
`they were expected to share.
`Slide 32 Dr. McCarthy putting the material on his bookshelf, making
`it accessible.
`So where are we?
`Slide 25 is just an extract from our reply at page 8 to 9. We have got
`105 people receiving the video. We know it's not confidential.
`It's being handed out at educational meetings for the purpose of
`spreading the word, for the purpose of giving doctors the best newest
`techniques for them to go home and share that information so that all of the
`patients receive the best techniques.
`And as cited, Dr. Lenke, at Exhibit 1001, Paragraph 35, explained that
`people knew they could get the materials from Medtronic.
`And Dr. Yassir at Exhibit 1043, Page 25, explained these meetings
`were not a secret. People knew how to get this information.
`So, where we are is, we have a video and slides that should be
`considered printed publications. There should be no dispute about the
`relevant facts. And in fact, there is no contradictory evidence. There is
`attorney argument about that evidence but there is not any contradictory
`evidence.
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`So turning to Slide 48 again, let's talk about the well-known linkage of
`these screw extensions. If you turn to Slide 38, the '349 Patent, you have got
`screw extensions that are in two different vertebra along the longitudinal
`axis and across the vertebra. They are in a rigid frame, with T-handles that
`can be grasped.
`Slide 67, an image from one of our claim charts, where we explain
`near the bottom of the chart quoting from Column 5, Line 4 to 12, that the
`T-handles 100 of the present invention provide a positive linkage.
`We further explain quoting from that same passage, "The linkage
`insures that the force applied is evenly distributed to the pedicles, thereby
`decreasing the likelihood of damage to any one pedicle. That's the
`motivation for the linkage."
`And, your Honors, at Slide 41, Exhibit 1032, Pages 12 to 13, explain
`that the '349 Patent discloses a final fix-it or reduction frame that seeks to
`distribute applied forces evenly across the screws and pedicles and to control
`and produce flexion extension lateral bending and axial rotation.
`And we, at Slide 40 from the petition at Page 11, explain after citing
`to your Honor's decision, that the T-handles function as handles to allow
`manipulation of the spine and an even distribution of force between the
`pedicles in order to prevent excessive load to either pedicle. That's the exact
`same motivation that you saw in Suk and the exact reason why you would
`link Lenke's derotators.
`And then Slide 42 we explained in our reply in response to Dr. Barry
`saying that controlling axial rotation does not mean you could rotate it
`means you prevent it, but in fact the specification describes at Column 3,
`Line 24 to 32, rotating the vertebrae to produce the desired alignment.
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`Controlling cannot be not rotating, if the specification's describing
`rotating.
`And at our petition, Page 57 to 58, which is Slide 160, we explain that
`there would be a motivation to link the Lenke derotators in view of the
`teachings in the '349 Patent to evenly distribute the force to avoid breaking
`the pedicles.
`So let's talk about the '568 Patent for a bit. Slide 45. And there is the
`front page of the '568 Patent, and you see there the rigid jack, as they call it,
`which is provided for leverage to provide the manipulations that are
`described in this patent.
`And slide 76, an extract from our claim chart, where the levering
`member 20, which is the handle that attaches those two extensions, is
`providing leverage.
`And you see at of the bottom of that chart quoting from Column 1,
`Lines 48 to 65, the reduction -- and in this context we are talking about a
`spondylolisthesis reduction -- may require manipulation of the vertebrae and
`the sacrum in one or more directions, including rotation about the vertebral
`axis.
`
`So the '568 is talking about a rotation about the vertebral axis. And,
`again, at Column 2, Lines 27 to 31, is a further object, an object of the
`invention, your Honor, to provide such an apparatus and method which
`enables the surgeon to rotate either or both the vertebra and the sacrum as
`required.
`And by the way, either or both the vertebra and the sacrum as required
`does not mean you are always connected to the sacrum. Clearly, it's talking
`about rotating either or both of the vertebrae.
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`Slide 74 from one of our -- from the petition at Page 31 to 32, any
`manipulation of the outrigger members, the screw extensions, is transferred
`to the spinal link members and thus the vertebra or sacrum to which they are
`affixed or sacrum so the rigid connection of the outriggers to the vertebra is
`what allows the manipulation of the vertebra.
`And then finally in the petition, Page 44 to 45, and this is Slide 159,
`we bring this together by explaining that a person of skill in the art would be
`motivated to link the Lenke derotators to perform this maneuver and avoid
`damage to the vertebra.
`And we explained the '928 Application and/or the '568 Patent --
`actually we say "application" there, it should be "patent" -- individually or in
`combination provide the means, the way, the how for this mechanical
`connection.
`And so I know your Honors, in your final determination, felt like we
`had not explained -- or actually in your institution decision -- felt like we
`had not explained how to connect.
`And what we said here was, the means is, for example, in the '928 or
`in the '568, and in other parts of the petition in the '349. So you can choose
`any one of those three methods of linking or you can simply apply ordinary
`skill.
`You could use what a person of ordinary skill would understand,
`armed by the fact that you know it's well-known in the art to link, that it's
`well-known in the art to link to distribute force. That it's well-known in the
`art to link to make it quick and straightforward, as the '568 says it, for a
`manipulation for realignment of the spine, for axial rotation of the spine.
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`And in addition, and I know we talked about Suk quite a bit in our last
`hearing, Slide 111 discusses Exhibit 1031, Suk, at 347. And, again, talks
`about distributing the rotational torque among several pedicles to help
`prevent the pedicle breakage.
`This is the same motivation that you see, nearly the same words that
`you see from the '349 Patent. So in multiple references we see that it is well
`known in the art to have a desire to distribute the force to avoid breaking the
`pedicles.
`And, yes, in Suk, they distribute the force differently, but the
`motivation is still there, and it's well-known to link.
`And at that, although I guess I still have about two minutes, I'll go
`ahead and leave the rest of my time for rebuttal.
`JUDGE McNAMARA: You have 32 minutes left.
`MR. ALEMANNI: I'll take just a second to get us connected.
`JUDGE McNAMARA: Take your time.
`Are you ready?
`MR. ALEMANNI: Okay. I think we are ready, your Honor.
`JUDGE McNAMARA: All right. Do you to want to set aside a
`couple minutes for a surrebuttal?
`MR. ALEMANNI: Yeah, just a few at the end, whatever we have left
`once we're done.
`JUDGE McNAMARA: All right. So I'll just -- we'll just -- we will
`just let the clock run then. You can keep an eye on it and let me know.
`When you are done, you are done.
`MR. ALEMANNI: Thank you, your Honor.
`JUDGE McNAMARA: All right. Proceed.
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`MR. ALEMANNI: All right. Great. Thank you, your Honors. Good
`afternoon again. I'm John Alemanni on behalf of Dr. Barry.
`None of the references at issue on remand alone or in combination
`discloses a handle means that's linked for simultaneous derotation of
`vertebrae.
`And what I'm going to do is I'll take the references in turn. I will
`demonstrate that they don't disclose rotation. I will explain why one of skill
`in art would not combine the references in the way Medtronic suggests.
`I'll also explain why the primary evidence that they rely on, the
`testimony of Dr. Lenke is simply not credible. And because it's so
`foundational to their argument why that -- why that dims their arguments.
`And then what I will do is turn it over to Mr. Rinehart, and I'm going
`to have him explain why the video and slides were never published, that they
`are not publications, at least in the patent sense.
`And so with that I'll start with the '928.
`Can we bring up Medtronic’s Slide Exhibit 1061, Slide 48, please?
`So these are the devices that -- that -- that they talked about in their
`opening. And the one in the middle is the '928. And we talked extensively
`about the '928.
`Medtronic opened with the argument, well, you know, there's -- it
`doesn't need to be more than minimal rotation to satisfy the claim.
`But your Honors found in the final written decision, and the Federal
`Circuit affirmed, that spondylolisthesis, which is what the '928 is designed to
`address, has the most minimal rotation and that's not relevant to the -- to the
`claims, and the Federal Circuit affirmed that finding.
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`And so, the -- you found
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