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`IN RE: NuVASIVE
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`CASE NO.: 2015-1672
`________________________/
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` TRANSCRIPTION OF AUDIO RECORDED PROCEEDINGS
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`RECORDING OF: Court Hearing
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`TAKEN BEFORE: Judge Kimberly Ann Moore
` Judge Richard Taranto
` Judge Evan Wallach
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`COUNSEL FOR NUVASIVE: Michael T. Rosato, Esquire
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`COUNSEL FOR INTERVENOR: Joseph Matal, Esquire
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` Transcribed by:
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` Melissa Iadimarco
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` Court Reporter/Transcriptionist
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`NUVASIVE - EXHIBIT 2045
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
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`IN RE: NuVASIVE
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`CASE NO.: 2015-1672
`________________________/
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` TRANSCRIPTION OF AUDIO RECORDED PROCEEDINGS
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`RECORDING OF: Court Hearing
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`TAKEN BEFORE: Judge Kimberly Ann Moore
` Judge Richard Taranto
` Judge Evan Wallach
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`COUNSEL FOR NUVASIVE: Michael T. Rosato, Esquire
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`COUNSEL FOR INTERVENOR: Joseph Matal, Esquire
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` Transcribed by:
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` Court Reporter/Transcriptionist
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`NUVASIVE - EXHIBIT 2045
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
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` P R O C E E D I N G S
` THE BAILIFF: The United States Court of Appeals
` for the Federal Circuit is now open and in session.
` God save the United States and this Honorable Court.
` JUDGE MOORE: Please, be seated. Good morning.
` Our first case for today is 2015-1672, in RE:
` NuVasive. Mr. Rosato, please proceed.
` MR. ROSATO: Thank you, Your Honor. And I had
` reserved five minutes for rebuttal. May it
` please the Court. As Your Honor noted, this is an
` appeal from two inter partes reviews, the 2013 507,
` 508, both involving NuVasive's Patent No. 8187334,
` directed to lateral spinal fusion implants.
` Respectfully, the board's finding of unpatentability
` should be reversed because the decision, both
` decisions in both of the IPRs errored by crafting and
` relying on new grounds of unpatentability in its final
` written decisions, while explicitly refusing to give
` NuVasive an opportunity to respond.
` JUDGE MOORE: Well, is it really a new ground of
` unpatentability? It's Figure 18, correct? Is that
` what we're --
` MR. ROSATO: Correct.
` JUDGE MOORE: -- talking about? Of the same
` reference that was the ground of patentability that
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` was being considered. At all times it was obviousness
` of these particular references in combination. So why
` is it a new ground of patentability?
` MR. ROSATO: It's a new ground because the theory
` of unpatentability and the thrust of the invention,
` had completely changed. It changed from one theory
` and a particular embodiment, to a completely different
` embodiment that quite frankly addresses or presents a
` type of implant that is fundamentally different, not
` only from the embodiment of the Michaelson disclosure
` that was originally relied upon, but every other
` single implant that was addressed or presented in any
` of the references.
` JUDGE WALLACH: You're the one who, in your
` response before PTAB included Michaelson 16, 19 and
` 20. And 16 and 19 are on the same page. And in
` between them is 18. But you didn't include 18. Why
` not? That says something to me.
` MR. ROSATO: Well, okay. Well, I'm interested to
` hear what that says. My explanation of that would be
` Figure 18 and Figure 19 are describing the same
` embodiment. Figure 18 shows one piece of a
` multi-piece assembly implant. So the point that was
` being made in the response, and it's a valid and
` unrebutted point, Your Honor, is that all of the
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` implants in Michaelson are designed to be oversized,
` both in length and width. And that was the point.
` JUDGE WALLACH: What, you're interested in what
` it says to me? It says when you exclude something
` from the body of a document, and it turns out that
` that information is relevant, then it tells me that if
` I were at a trial level anywhere, I would immediately
` say to myself, gee, what's in that hole.
` MR. ROSATO: In the -- you know, it's a -- it's a
` fair question to want to know what's there. I don't
` think there was any intent to skip over things. The
` point that was being made --
` JUDGE WALLACH: Well, of course there was. You
` left it out. It was left out. I mean --
` MR. ROSATO: Well, I respectfully would submit
` the intent was not to hide anything, Your Honor. The
` point being made, and if you read the briefing on that
` point, was taking the petitions --
` JUDGE WALLACH: You can take it. We read the
` briefing.
` MR. ROSATO: Okay. I -- I feel very assured that
` that is the case. But the -- the argument that was
` being made was in response to what was presented in
` the petition. The petition case was resize the
` primary implants according to the dimensions of the
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` Michaelson implant. And there was one implant cited
` in the petition. So taking that suggestion to its
` logical conclusion was the argument.
` JUDGE WALLACH: Why wasn't Hynes asked about 18?
` Because you were permitted below to cross examine him
` and file motions for observations and so on?
` MR. ROSATO: So this gets to the issue of whether
` observations on cross examination after reply
` constitute an opportunity to respond. And they don't.
` JUDGE TARANTO: Well, it's some opportunity. It
` just may not be enough opportunity.
` MR. ROSATO: True.
` JUDGE TARANTO: You can't put in your own
` evidence.
` MR. ROSATO: Exactly.
` JUDGE TARANTO: Right. So can I just focus on --
` on this? In one of the two Medtronic petitions, there
` is a reference to -- what is it, Column 10, which --
` of -- of -- of Michaelson, which contains the
` descriptions of 18 and 19. And let's just assume for
` these purposes that 18 and 19 teach the same thing in
` terms of a long and wide and narrow implant, each one
` of them all by itself. Why was, just as to that,
` which is -- is that the 507? That's the 507 IPR?
` MR. ROSATO: I think it's the 507, right.
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` JUDGE TARANTO: Yeah, which includes all the
` claims except for 16 and 17. Why is that not
` sufficient notice for you to have understood that you
` should address what was in Column 10 of Michaelson,
` which indeed you did. And in fact, you did it not
` only in 507, but in 508 where there was no such
` counter part in Medtronic's petition. So where is the
` missing opportunity to be heard? Because maybe your
` patent owner's response was that opportunity without
` more.
` MR. ROSATO: It was an opportunity. But again,
` this goes back to the original theory presented, which
` was focused very specifically. If you look at the
` claim charts that are actually presented and how
` Medtronic maps the relevant elements of the claim to
` the disclosure of Michaelson, they are relying only on
` Column 10 Lines 41 through 46, which is a discussion
` of the Figure 16 implant. As to --
` JUDGE TARANTO: So what I'm recalling and tell me
` if I'm wrong, is that in Medtronic's 507 petition,
` there was, first of all, the long primary argument
` about is it Frey(phonetic) or Frey?
` MR. ROSATO: Frey, yeah.
` JUDGE TARANTO: Frey, yeah, Frey. And then
` there's an argument that says, well, okay put aside
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` Frey by itself. We now have Frey plus other stuff,
` including Frey plus Michaelson. And then there's a
` discussion of Michaelson, saying as to these elements
` of your claim, A through G and something else, but I
` think G is the crucial one, right? G is the one that
` has the ratio of length greater than or equal to 3.5
` times width, right. And it's in that discussion that
` Medtronics said see Column 10 of Michaelson. And it
` shows longer than wider. And there's no other claim
` element that that could have been applied to, could
` have made any sense except for the 2.5 one. So why
` wasn't that sufficient.
` MR. ROSATO: Yeah, so two points. So the Frey
` alone theory was completely rejected at --
` JUDGE TARANTO: Yeah.
` MR. ROSATO: -- institution. So again, there's
` two parts of the petition. And as an initial matter,
` I would note that Medtronics has not advanced this
` argument. They never asserted that that reference
` you're referring to Your Honor constituted notice or
` that they, in fact, did ever rely on this modular
` implant embodiment. That's --
` JUDGE MOORE: I just want to clarify one thing
` factually, because I'm not positive I understand the
` facts exactly right in light of the discussion you are
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` having with Judge Taranto. Factually, I thought
` Medtronics only relied on Michaelson, Column 10
` roughly 41 to 46, for purposes of length greater than
` 40 millimeters. I didn't remember them relying on
` Michaelson to prove the 2.5 to 1 ratio. Am I
` misremembering -- I very well may be misremembering
` the facts. So I want you to make it very clear.
` MR. ROSATO: Yes. If you look at the claim
` chart, when it's the 40 millimeter length, they
` specifically cite to just what Your Honor identified,
` Column 10, lines 41 through 46. For the 2.5 to 1, I
` don't know that they specifically map that up. But
` that's critically tied to the same thing.
` JUDGE TARANTO: So just -- what I'm looking at is
` --
` MR. ROSATO: Yeah.
` JUDGE TARANTO: So A172, which is I think their
` petition in 507.
` MR. ROSATO: Uh-huh.
` JUDGE TARANTO: And it's under the Heading D,
` Ground 4, Claims 1 through 5, et cetera are obvious
` over Section 103 over Frey in view of Michaelson. And
` it says with respect to elements A through D, F
` through J and then you go on to 172 and about -- I
` don't know, two-thirds of the way down, like Frey,
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` Michaelson discloses example lateral fusion implants
` having an elongated shape, dimensions that are longer
` than wide and wider than tall with a large internal
` space see Michaelson basically all of column 10.
` MR. ROSATO: All of column 10, yeah.
` JUDGE TARANTO: Okay. So that includes that.
` And item -- Element G is the 2.5.
` JUDGE MOORE: Right.
` MR. ROSATO: Yes.
` JUDGE TARANTO: So why -- that's not limited to
` the particular five lines that you were citing before.
` MR. ROSATO: Sure.
` JUDGE TARANTO: That's what I was focusing.
` MR. ROSATO: Understood. And I do want to
` address that point because it's an important one. So
` just the clarify how this read: I think the paragraph
` referencing -- these are set up to introduce the
` section as we're going to -- we, petitioner, are going
` to do an element by element showing. And we're going
` to -- we're going to talk about rationale. So that I
` wouldn't tie together those two paragraphs as -- as
` conflated into an element by element showing. I guess
` is one point of distinction. But the pair, if you're
` referring to, Judge Taranto, is discussion of
` rationale to combine.
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` If you look at what they're arguing there,
` they're essentially saying these two references are
` both directed to spinal fusion implants. They're
` analogous art. And that paragraph concludes, in -- on
` a -- A174. This is all one huge paragraph. It
` concludes thus the combinations made from these are
` merely simple combinations. So this isn't the context
` of rationale to combine. So it's not in the context
` of an element by element showing. And two, it's so
` general that they -- they say to practically every
` embodiment in terms -- to support the point that these
` are both -- both references, Frey and Michaelson are
` directed to implants.
` JUDGE TARANTO: Can I ask this as a -- I guess a
` slight variation. Correct my premise if it's wrong.
` MR. ROSATO: Yeah.
` JUDGE TARANTO: My understanding was that even in
` this, what Medtronic was saying was we can find the
` length with ratio in Column 10 of Michaelson, just
` stipulate that for purposes of this question. I know
` you kind of disagree with that. What the board ended
` up doing was saying, we can find in Michaelson both
` the 40 millimeter length and the length/width ratio
` which maybe -- is that different from this, and would
` that difference matter?
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` MR. ROSATO: Yeah, it's a very critical point
` you're picking up on, Your Honor. So the -- what the
` board rejected -- let's think about what the board
` rejected in terms of arriving in a combination. They
` rejected this buffet approach where you start with an
` implant and then look to another implant of Michaelson
` and take one dimension, but not all of the dimensions.
` That was the original theory presented in the
` petition. And the board rejected that. We know they
` rejected that because they specifically said, in the
` context of Claim 18, which they upheld, that there's
` no rationale to pick one dimension from an implant.
` They ended up invalidating the claims they did
` because they felt that they could find the dimensions,
` the length, the -- the length to width ratio and the
` 40 millimeters all in the single module piece. That's
` how they came to this. They were unwilling to pick
` selectively dimensions from an implant. They were
` only willing, in the absence of a specific rationale,
` to do otherwise, take an implant and Michaelson and
` resize the primary reference --
` JUDGE WALLACH: I want to get a little bit of APA
` in here, since we haven't touched it at all.
` MR. ROSATO: Yeah.
` JUDGE WALLACH: Take it as a given that if we
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` affirm PTAB's decision in either IPR, then it's
` invalidated. It's obvious. And the other one goes.
` But you've also got APA arguments. If -- if -- is
` there any reason we should treat 507 different than
` 508, under the APA analysis, or does it rise and fall
` the same way?
` MR. ROSATO: That's a fair question. So as far
` as notice and opportunity to respond, I would say for
` the reasons we argued in our briefing, there was no
` opportunity. Again, looking at the -- in -- you know,
` just to make this point clear. And I'll get to, more
` specifically, yours. But just to make clear: This is
` a new theory as we argued that came up in reply. We
` asked multiple times for an opportunity to respond,
` and didn't get that. And you can see that in the
` record.
` JUDGE TARANTO: What do you do with Genzyme?
` MR. ROSATO: With Genzyme, Genzyme, I would
` embrace Genzyme. Genzyme is a situation where it's
` very different. I would actually embrace Dell versus
` Exceleron more because the facts are more similar.
` JUDGE TARANTO: They come out differently too.
` MR. ROSATO: They come out differently, but the
` facts explain why that come out -- they come out
` differently. Dell, you had a situation where the very
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` same reference was being utilized and there was a
` pivoting between the components of the reference to
` meet a claim limitation. That changed in the reply
` brief that then further changed in oral hearing.
` Genzyme was different. That theory was the same,
` starting from the beginning, that in vitro data was
` predictive of -- of the in vivo success.
` That was -- so it was a situation of yes it is,
` no it isn't, yes it is. Right? Yes, it is predictive
` institution -- I'm sorry. Institution decision, yes,
` it is. Reply, patented response, no, it isn't.
` Reply, yes it is. So it's the same issue, the same
` thrust of the invention. Just like we have similar to
` the Belden (phonetic) case. Well, you've got the same
` issue that's being substantiated throughout the
` record. That's very different from starting with a
` particular theory and then recognizing a deficiency
` and turning to different content within the reference
` or different embodiments.
` JUDGE MOORE: I'd like to go on for a second to
` Judge Wallach's question because your time is up and
` your rebuttal time is almost up on top of it. But let
` me ask one last question, which is: So there's a
` difference in the 507 and 508. In 507, as Judge
` Taranto pointed out on Page 172, they actually
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` reference Michaelson and the particular section in the
` context of the ratio discussion. Arguably in 508,
` though, there's no reference to Michaelson --
` MR. ROSATO: True.
` JUDGE MOORE: -- at all.
` MR. ROSATO: Yes.
` JUDGE MOORE: So certainly 508 undoubtedly is a
` better case for you, right? I mean, because in 508,
` the petitioner never even referenced this portion of
` the reference. Does that matter? I think that's part
` of where Judge Wallach was in the beginning.
` MR. ROSATO: Yeah.
` JUDGE MOORE: And it's part of what I want to
` know from you, too.
` MR. ROSATO: Yeah.
` JUDGE MOORE: Which means, do I -- does your best
` case scenario matter or is it irrelevant because
` if I conclude you did have an opportunity in 507 to
` respond, 508's irrelevant.
` MR. ROSATO: Yeah. Well, I would say there's no
` way that -- I'm sorry, but there's no way that that
` general citation in the front should count as notice.
` JUDGE MOORE: Yes, but that's not what I've asked
` you.
` MR. ROSATO: I know --
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` JUDGE MOORE: So try the focus on answering my
` question.
` MR. ROSATO: I know it's not. Assuming that it
` does, on that point it would -- if that's the pivotal
` point, it would matter between the two references.
` But it gets to a fundamental point also --
` JUDGE TARANTO: I'm sorry, I didn't -- it would
` matter between the two references?
` MR. ROSATO: I'm sorry. I said references. I
` meant petitions.
` JUDGE TARANTO: 508 is the only one that includes
` Claim 16 and 17. 507 doesn't; is that right?
` MR. ROSATO: Correct.
` JUDGE TARANTO: So there's actually two different
` claims that are unaccounted for?
` MR. ROSATO: Correct. There would be overlapping
` --
` JUDGE TARANTO: But what about notice? I mean,
` you filed exactly the same, on this point, patent
` owner's response in your 507 and 508, patent owner's
` response, even though you had lesser -- less material
` to respond to in 508. Doesn't that show you had the
` notice of the point in 508 or is that not a fair
` point?
` MR. ROSATO: I don't think it's notice, Your
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` Honor. I think really what was being done is trying
` to characterize what is the state and invention of
` Michaelson and point out that what the state of the
` art of lateral implants, if Michaelson is presenting
` that, what that's teaching you is to make your
` implants as wide as possible, to maximize coverage of
` the disc space. So the combination is ultimately
` going in a direction opposite of what the state of the
` art was recognized at the point.
` So it was really a rationale point that was being
` made. There's no reason to resize the primaries to
` make them long and narrow in view of Michaelson. And
` the critical point -- I really want to make sure I hit
` this before we conclude, is does this -- to the
` question of does this all matter. There is the
` process issue, but there also is, at the end of the
` day, a factual record that looks exactly what you --
` what you would expect it to look like when something
` comes up very late in the process. And that is an
` undeveloped and unexplained theory of nonobviousness,
` right. So there's no -- in other words, there's no
` explanation in the final written decisions or in
` Medtronic's petitions or any of the materials or reply
` brief, why a person would resize a primary reference
` according to a modular -- one piece of a modular
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`
` implant.
` JUDGE WALLACH: Well, why were these adoptions of
` arguments rather than evaluations of the record, which
` included Michaelson 18?
` MR. ROSATO: Why were these adoptions -- excuse
` me?
` JUDGE WALLACH: Why were the PTAB's final written
` decisions adoptions of arguments.
` MR. ROSATO: Why are they adopting these
` arguments?
` JUDGE WALLACH: Yeah, rather -- that not
` presented, because that's what you are saying, as
` opposed to they're saying they're evaluating the
` evidence, which is what they do.
` MR. ROSATO: Well, I don't know if they say
` they're -- we don't know why. I mean, this is a
` problem that came up in the Verinata case as well. We
` don't know why they brought these together.
` JUDGE WALLACH: Can they be discerned?
` MR. ROSATO: There's nothing in the record in the
` decisions or in the reply materials why a person
` of ordinary skill would look to one piece of a modular
` implant, a completely different type, and then resize
` a different type of implant according to a one piece
` of -- right, of a different type of implant. They're
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` just -- I mean, there is no explanation.
` JUDGE TARANTO: Can I just ask you one -- one
` question?
` MR. ROSATO: Sure.
` JUDGE TARANTO: Just about I guess the 508.
` There, it wasn't Frey that was being relied on so much
` as what SVSPR and Telamon if I'm not mistaken.
` MR. ROSATO: Yes.
` JUDGE TARANTO: Both of those -- I think I'm
` correct in saying the board did not find the
` following, but tell me if I'm wrong in thinking that
` SVSPR and Telamon make it, you know, beyond dispute.
` Both of those show certain implants with a length to
` width ratio of greater than 2.5. They're not long,
` but they are much longer than wide. Is that right?
` MR. ROSATO: Yes. They do, but this still
` doesn't answer that rationale, right. If the board
` does what they did, which is, you know, a claim
` mapping exercise to identify elements between
` different types of implants, they can find that ratio
` in the SVS and Telamon, where rationale comes in is
` SVS and Telamon are a completely different type of
` posteriorly inserted implant, where those dimensions
` make sense for that purpose. You go to Michaelson.
` It's a completely different type of lateral implant
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` where Michaelson is telling you, you no longer are
` coming in from the back. You no longer are working
` around a spinal cord and these other anatomical
` restrictions. Maximize the placement of the disc
` space and make this as wide as possible.
` So there's a rationale issue as to why a person
` would resize one type of implant to essentially turn
` it into a completely -- well, that's even going too
` far, to turn it into a different -- it become as
` hybrid implant with no -- with no rationale as to why
` you would do that. And that's something --
` JUDGE MOORE: Okay. Counsel, I think we're way
` beyond your time. So why don't you sit down, and
` we'll hear from the PTO.
` MR. ROSATO: Yeah. I would ask --
` JUDGE MOORE: No. Counsel, sit down. Let's go.
` MR. MATAL: Your Honor, may it please the Court.
` The PTO originally intervened in this case in order to
` address certain procedural issues --
` JUDGE TARANTO: So Mr. Matal, Mr. Rosato embraces
` Genzyme, but even more dearly embraces Dell. And in
` your green brief, you argue that NuVasive was provided
` adequate APA procedural protections. Tell me how this
` case is distinguishable from Dell and more
` importantly, between those two cases, where do we draw
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` the line for adequate procedural protection and
` safeguards under APA?
` MR. MATAL: Your Honor, it's simply a case by
` case determination. Genzyme, the latest -- the
` Court's latest statement on this, provides the
` relevant standard. The inquiry under both the APA and
` the due process clauses, did the -- did the party have
` adequate notice of the issues that would be considered
` and did it have an opportunity to respond at a
` meaningful point in the proceeding. Now we all agree
` that the period of the patent owner response is a
` meaningful opportunity to respond. So the relevant
` question is: Did Medtronic's petition combine with
` the institution decision give NuVasive adequate
` notice.
` JUDGE MOORE: Well, let's start on the 508 only,
` because that's your worst case. So let me start on
` your --
` MR. MATAL: Your Honor, I believe 507 is the one
` that involved Frey and Michaelson and it's 508 --
` JUDGE MOORE: That's why I want you to start on
` 508, which is your worst case.
` MR. MATAL: Your Honor --
` JUDGE MOORE: For providing notice.
` MR. MATAL: Yes. Your Honor, there is an
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` important point I'd like to raise with regard to 508.
` It goes to the merits. It's not something that the
` PTO address, because again, we would assume that
` parties would address the merits. But because
` Medtronic's is not here, I'd like to point out in
` Section 2 of Medtronic's brief, they point out that in
` 508 the board entered an independent and separate
` finding that the claims were unpatentable based
` on the combination of SVSPR and Telamon as modified
` in view of Michaelson.
` And as Medtronic notes in its brief, that
` combination is never addressed in
` NuVasive's briefing in that court. That combination
` affords an independent basis for invalidation of the
` challenged claims. And it's simply no rationale has
` -- no reason has been presented for disturbing the
` board's findings in this case. I think the Court's
` important enough that it's worth even taking a look at
` the board's written decision in 508.
` In that case, the board begins framing the issue
` at Page 5 of its decision. This is about Page 21 of
` the record. And the board points out petitioner is
` arguing in this case that you can take either SVSPR or
` Telamon, both of which disclose the long and narrow
` limitation. And it's saying -- and petition -- and
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` this is the board again. It's saying petitioner says
` you can modify this in view of Medtronic's suggestion
` of a longer implant. And it notes that Medtronic
` suggests this modification for purposes of stability
` and for -- as the board puts it, as applied
` dimensional optimization in accordance with the prior
` art.
` JUDGE TARANTO: And when you say the board found
` this about SVSPR, what you're referring to is its
` quotation of what Medtronic argued in the petition --
` MR. MATAL: So this --
` JUDGE TARANTO: -- not its own findings; is that
` right?
` MR. MATAL: This is where it framed the issue.
` The board's finding appears at about Page 26 through
` 27 of the record. At Page 24, it addresses NuVasive's
` argument. NuVasive argued oh, you can't combine
` these. You can't link them. SVSPR --
` JUDGE MOORE: Where -- you said 26 to 27.
` MR. MATAL: 26 to 27.
` JUDGE MOORE: Tell me right where --
` MR. MATAL: Page 26 through 27 of the joint
` appendix. I think it would be about Page 10 of the
` board decision, beginning towards the bottom of Page
` 10. And the board began addressing the two parties's
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` arguments. NuVasive had argued that no, you can’t
` combine them because the SVSPR and Telamon are
` posteriorly inserted implants and if you link them too
` much, then they injure the interior space of the disc.
` This argument is fleshed out in the patent owner's
` response. They argue that if you make this posterior
` implant too long, it will injure the aorta and the
` venae cavae --
` JUDGE MOORE: Well, and this is -- forgive me if
` I'm wrong. This is all about the 40 millimeters in
` length, right? But does this have anything at all to
` do with the ratio of 2.5 to 1, this discussion that
` you're pointing me to?
` MR. MATAL: Yes. It's at this passage that the
` board finds that -- it weighs the two parties's
` arguments and concludes -- it agrees with the
` petitioner that you can modify both SVSPR and Telamon
` in accordance with Medtronic's suggestion of a longer
` length. First it finds that it doesn't matter that
` SVSPR and Telamon are posteriorly inserted because the
` claims don't require that it could be a lateral
` implant.
` And then the board, I think this is at the top of
` Page 27, goes on to directly address this argument
` about posterior implants. And here, the board cites
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` the Tohmeh reference. Tohmeh is
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