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` TRANSCRIPTION OF AUDIO 2015-1670
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`NUVASIVE - EXHIBIT 2017
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
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` JUDGE MOORE: -- also in re NuVasive. And, Mr.
` Rosato, when you're prepared, go ahead and begin.
` MR. ROSATO: Thank you, again, and may it please
` the Court --
` MALE VOICE: Nice to see you again, Mr. Rosato.
` MR. ROSATO: So in this case, again, dealing
` with spinal fusion implants, here the Board's finding of
` unpatentability should be reversed because here even --
` well, again, starting with -- there are two issues. I'm
` going to address the rationale, the combined issue first.
` But even assuming that these references are prior art,
` the Board here failed to provide reasons why a person of
` ordinary skill in the art would have combined these sort
` of references.
` The entirety of the Board's reasoning is found
` at A-11 through A-13, and the issue was whether a person
` of ordinary skill in the art would have any reason to
` modify the primary references, which were posterior
` inserted implants or implants designed for posterior
` insertion to include radiopaque markers located in the
` medial plane --
` Q. Are you going to -- are you going to abandon the
` -- the accessibility of the references argument?
` A. No, Your Honor.
` Q. Okay. You had -- you had -- you had challenged
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`Page 3
` public accessibility during institution proceedings. But
` you didn't challenge it during the trial phase. How are
` you not barred from challenging under Cuozzo?
` A. Under Cuozzo?
` Q. Yeah.
` A. Well, excellent question. So actually, if you
` look at what the Board said in their institution
` decision, we're not -- one, we're not necessarily
` challenging that. But it only goes so far. What the
` Board said in their institution decision that's at A-186
` is that, essentially, the Board recognized the
` deficiencies with the evidence that Medtronic -- sorry,
` that NuVasive was identifying in their preliminary
` response. The Board didn't disagree with that. They
` specifically noted the vague and general nature of that
` evidence and said this is good enough to get you
` institution at the lower standard for institution --
` Q. We understand all those facts, but then at the
` hearing, Judge Green said I take it you are no longer
` disputing the public availability of the Telamon
` reference. And Mr. Nelson, a different counsel, not you,
` said that is correct. We're leaving that issue aside.
` A. Right, yeah.
` Q. No longer disputing. How does that not
` constitute a waiver of the issue? And it was never
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` brought up at any other point during the hearing. It's
` not like he said, oh, when we said not disputing, we
` meant not right now. We're going to dispute it later.
` There was never another -- why would the Board have
` reached public accessibility? Why would they need to
` resolve your dispute, which had been very efficiently and
` -- and well laid out earlier at the petition level. But
` here, when it got to trial, I take it you are no longer
` disputing -- that's correct, Your Honor.
` A. Yeah.
` Q. What -- what -- how is --
` A. Absolutely fair question, Your Honor. What --
` what --
` Q. You gave me a lot on that. Go ahead.
` A. Yeah. So if you look -- if you look at the --
` the whole quote, I mean, it -- it's -- we wish he was
` more clear on that. What he's --
` Q. No, you wish he was less clear.
` A. Well, look at the rest of his statement. He --
` he said -- he goes on to note a number of other things
` that he's not going to be addressing and specifically
` says I'm not abandoning those issues. So it was a
` terribly articulated statement. But at best, it's -- I
` would say at best, it's ambiguous. And he's not trying
` to expressly abandon it. He's trying very inarticulately
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` to express what he's prioritizing as --
` Q. Well, if you went to the merits, each of those
` references is copyrighted, right, in 2002 and 2003.
` A. Yeah.
` Q. And has a 1-800 number on it. Aren't they
` inherently publicly accessible?
` A. Well, I mean, copyright, maybe that illustrates
` it was fixed in a tangible medium of expression. But it
` doesn't address public accessibility. They may have, you
` know, they may have put it in -- put it in print. But
` this goes to the issue of scope of review. I mean,
` there's a reason why --
` Q. Isn't there a copy on file of -- by law with the
` copyright office?
` A. It doesn't say registered. It just says
` copyright. So there's not a registration. There's no
` indication, for example, this went to the Library of
` Congress.
` Q. Were these user manuals?
` A. I think they were, like, yeah user -- they were
` brochures.
` Q. I mean --
` A. It was a sales brochure.
` Q. And they say for reference only on them. And
` you make an argument that -- that -- that indicates
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` confidentiality. But why isn't it equally possible that
` it indicates a limitation of liability?
` A. We just don't know what it means. That's --
` that's the point. I mean --
` Q. Well, that makes it a weak point.
` A. It was the same thing the Board noted in their
` institution decision, which is the evidence, at best, is
` vague and general. And it meets the lower standard. But
` there's an indication there it doesn't meet the higher
` standard, and so there are problems with this. The
` problem within the context of this -- this type of review
` are two things. One, these reviews are specifically
` designed to be limited to prior patents and printed
` publications because these proceedings are designed to
` encompass a use type case of, you know, what's out there
` in the marker to what people are using. The discovery
` tools and the timing just doesn't comport with that type
` of case.
` But two, the rules specifically give Medtronic
` an opportunity -- and this is what the Board was
` signaling -- to file a motion for supplemental
` information under Rule 42.123 to add information to
` substantiate their case. There's a timing for doing that
` within one month of institution, and Medtronic never did
` that. So if you look at what the Board said, they're
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` saying Medtronic -- you get in, but it's not very good.
` And you -- you bear the ultimate burden on this. Never
` flip to NuVasive to satisfy this. So at the end of the
` day, they didn't -- Medtronic didn't do anything to
` correct this. And, you know, at the -- it just leaves --
` it -- it leaves the issue open.
` Q. If you don't mind, I'm just going to move --
` Q. The same thing --
` Q. If you don't mind, I'd rather you get to your
` motivation to combine point, and in particular, why don't
` you start with why isn't Dr. Yuan's testimony, which
` identified advantages of the particular kinds of implants
` and the -- arguably the combination -- why isn't that
` sufficient? Why couldn't the Board rely on that to
` supplement or provide adequate support for motivation to
` combine, which is a question of fact that we review for
` substantial evidence? So I don't get to look at this de
` novo. So why -- why isn't that good enough?
` A. Sure. Because he's not talking about state of
` the art prior to the invention. He's talking about a
` NuVasive implant that embodies the claimed invention that
` arose after the filing date. And he's explaining that
` the markers placed in the medial plane of that NuVasive
` implant provided the ability to line up the middle of the
` implant in a lateral procedure with an anatomical
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` reference point, the spinous process, which is basically
` the bony ridge down the posterior surface of your back.
` But in that lateral procedure, those markers allowed
` alignment and positioning of the lateral implant. So it
` doesn't -- it doesn't work for two reasons. One, he's
` not talking about state of the art prior. He's talking
` about benefits realized. Two, the very things he's
` talking about don't apply to the -- to the different type
` of implants that are being modified. Those are posterior
` implants that come in from the back and go anterior -- or
` posterior to anterior. So you've got the reference, the
` anatomical reference point that bears, you know, no
` relation to the positioning of that type of implant.
` Q. Can I ask you, I guess, a version of that
` question but not for Yuan but rather for paragraph 68 of
` -- is that Hynes?
` A. Um-hum. Yeah.
` Q. On page A-591. Now, in the Board opinion, this
` is, again, in the -- I think what Mr. Matal called in the
` earlier case the framing of the debate rather than
` findings by itself, so.
` A. Yeah.
` Q. I realize that may be very significant. But I'm
` -- I'm going to try to put that aside for a minute. The
` Board says at A-9, which happens, happily, to be page 9
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` of its opinion.
` A. Um-hum.
` Q. According to Petitioner, it would have been
` obvious to the ordinary artisan at the time of invention
` to include the radiopaque markers of Baccelli in the
` implants of SVS or Telamon in order to provide additional
` information regarding location and/or orientation of the
` implant both during surgery and after implementation.
` And it cites this paragraph on page A-591, which is not
` written about later knowledge of benefit but is actually
` written -- it is my opinion that prior to the earliest
` effective date, a person of ordinary skill in the art
` would have considered it blah, blah, blah to provide
` additional information.
` A. Um-hum.
` Q. Assume with me for purposes of this question,
` though I know you will disagree, that that might be taken
` to be an agreement with that point because the Board
` immediately goes on to say, while patent owner responds
` this, we're not persuaded by the response. I realize
` that there is a bit of a jump there --
` A. Um-hum.
` Q. On the merits, assuming this were a finding,
` what would be insufficient about it, putting aside Yuan?
` Just this.
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` A. Yeah. Why isn't that good enough, in other
` words?
` Q. Yeah.
` A. And this was a point of dispute or point of
` contention by NuVasive is that's so vague and general in
` nature. Simply saying, hey, you get more information,
` and it's common sense to want more information, doesn't
` provide a sufficient reason why you would want that
` information.
` Q. If it were -- provide additional information
` regarding the orientation or location of an implant
` during surgery. I mean --
` A. What this means -- yeah, what is that
` information?
` Q. Well, you want to see where the thing is.
` A. Um-hum.
` Q. That's -- I mean --
` A. So is that -- so -- so I want to address that in
` two parts. One is why standing alone isn't good enough
` because it doesn't say what kind of information you want.
` When combined with the rebuttal evidence --
` Q. Well, it does in the sense that its -- its
` placement in space.
` A. Right, but remember --
` Q. It seemed like a big deal.
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` Q. Yeah.
` A. And it is, but it's a big deal that's met by the
` fact that those implants already have radiopaque markers
` on them. They're just put in different places.
` Q. Right.
` A. And they're put there because those places make
` sense in the context of that type of implant.
` Q. The other ones, there -- there are just two?
` One kind of front and -- one distal and one proximal?
` A. Correct.
` Q. And then Telamon and SVS say, well, if you put
` two more in, it -- it allows us more information about
` orientation in space.
` A. Well, okay, so just to -- to correct that. SVS
` and Telamon have markers at the front of the -- and the
` back. That makes sense for --
` Q. One -- one each.
` A. One each.
` Q. Okay.
` A. And that makes sense for the purpose of
` advancing something posterior to anterior and making sure
` you don't -- you go far enough but not too far, and you
` can measure where the -- you know, the ends of the
` implant are relative to the disc space. Adding markers
` to the middle only makes sense when -- it doesn't make
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` any sense or provide any useful information in that
` context. It provides noise in a signal-to-noise
` situation. It just doesn't give you signal, in other
` words. Right? So that's a rationale problem. If you're
` -- you can add noise, it gives you more information.
` There's just no reason to do it. And that, actually, is
` consistent with additional information from both experts,
` both of them saying that sometimes, yes, the state of the
` art was you generally want as little as possible. And
` designer is very purposeful about where you place --
` Q. As little as necessary.
` A. As little as necessary, yeah. If it's not
` necessary to -- you know, when there's no reason to put
` markers in the middle of a short stubby implant, you
` don't do it. The only reason arises when you do what
` NuVasive did, which is you're lengthening out an implant
` and designing it to come in from a different -- to be a
` different implant. Right? Then you bring in different
` anatomical reference points, and now you have a reason
` why that helps you and makes sense.
` Q. Volunteer rebuttal time, would you like to save
` some?
` A. Yeah, I'll -- I'll -- I'll save, yeah, I'll save
` a little bit and let Counsel speak. Thank you.
` MALE VOICE: You're going to get awfully
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` comfortable in Medtronic's shoes.
` MR. MATAL: Your Honor, the office only
` intervened in this appeal about a week ago, and its
` intervention notice promised not to file a brief and to
` be available to respond to questions. In the absence of
` initial questions, I would like to respond to some of the
` points raised by --
` Q. Mainly, I want to know about motivation to
` combine. I don't -- don't talk about public
` accessibility. Just drop that point. Go right to
` motivation to combine.
` A. The motivation to combine, in this case, as
` Judge Taranto noted, it's stated by the Board at page 9
` of its opinion. It effectively credits the petition's
` arguments. It then weighs NuVasive's responding --
` Q. You might want to have emphasized more the word
` effectively.
` A. Effectively. Yes, Your Honor. I'll underline
` that. The Board then goes on to consider NuVasive's
` counterarguments that this is vague. It doesn't provide
` a rationale --
` Q. And what Judge Taranto meant was that an
` adjective or an adverb.
` A. Whichever -- whichever suits the case, Your
` Honor. I'm afraid I've lost the point.
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` Q. Well, I -- but -- but -- but -- but I mean,
` joking aside, the statement by the Board on page 9 is
` according to Petitioner it would have been obvious, and -
` - and clearly that entire paragraph is an articulation,
` in fact, with quotes Petitioner's petition. It's --
` that's not a fact finding by the Board clearly, right?
` A. You're right, Your Honor.
` Q. And the next paragraph is patent owner.
` A. Yes.
` Q. And that's not a fact finding. So you hinge
` everything on the single sentence that says we're not
` persuaded by patent owner's argument. Well, I understand
` you're not persuaded by patent owner's argument. Does
` that really mean you have adopted precisely the argument
` Petitioner that you quoted earlier when you said it's
` their argument?
` A. Effectively.
` Q. Yeah. No, I get that part. But that's where
` I'm a little --
` A. Your Honor, these are adjudicated proceedings,
` and the Board is presented with arguments from both
` sides. It listens to one side and explains its position,
` then hears from the other, and then --
` Q. It sure would be better instead of saying we
` are not persuaded by patent owner since the burden of
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` proof in this petition is on the Petitioner, right?
` Patent owner doesn't have to persuade you of anything.
` Who has to persuade you?
` A. The -- the -- the Petitioner always bears the
` burden in these proceedings.
` Q. Right. So the Petitioner has to persuade you.
` So to say you're not persuaded by the patent owner --
` A. It's --
` Q. -- can I really accept it as a given that the
` Petitioner has, therefore, persuaded you?
` A. It's perhaps an inelegant formulation in this
` case. But when all the information on those three pages
` is viewed in context, it's clear the Board is -- is
` addressing the issue of was there a motivation to
` combine. It's weighing the preliminary evidence. It
` doesn't credit the initial information in the petition
` because that's only partial evidence. It hasn't
` considered the rebuttal yet. And then it hasn't further
` considered the reply evidence. The Board did what an
` adjudicator is supposed to do in these cases. It weighs
` the evidence from both sides and then decides if the
` party who bears the burden has met that burden.
` Q. Where did it decide that? Where did it decide
` where the party who bears the burden has met the burden?
` A. There's no one -- there's no one sentence that
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` states that --
` Q. Yeah, I'm aware of this.
` A. In many of the Board's petitions, the decisions
` the Board doesn't expressly cite the burden. But it's
` presumed to follow its own rules. And it's certainly
` aware of its own rules. And in this case, again, when
` everything is viewed in context, it's considering both
` sides' arguments, and it's simply persuaded by one side
` rather than the other. That what happens in an
` adjudicated proceeding when both sides present their
` evidence back and forth, and the Board makes its final
` judgment under its rules.
` The Board was clearly apprised of a dispute over
` whether there's a motivation to combine. You clearly had
` NuVasive coming in in its patent owner response and
` contesting whether the motivation to combine presented by
` Petitioner was sufficiently specific, whether it
` presented a rationale. Medtronic then came back and
` provided reply evidence, and -- and further elaborated on
` its rationale. It further explained what's meant by
` orientation.
` I'd also refer the Court back to all of this
` comes out of the initial reference, Baccelli. It's
` Baccelli that tells you that placing markers in a
` particular location tells you about their location and
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`Page 17
` orientation, both before and after the surgery. And this
` isn't the case where we only have radiopaque markers on
` the prior art at the two ends, and the question is, oh,
` would someone have understood -- been motivated to move
` them to the center. Baccelli itself teaches --
` Q. Baccelli -- the spikes.
` A. Yes. Baccelli itself teaches radiopaque markers
` at that medial location.
` Q. Or it can be read --
` A. Yes, or it teaches them as an alternative
` embodiment.
` Q. No, no, no, I want to say -- it seems to me even
` the language of Baccelli need not have been read to teach
` that but it can be.
` A. It can reasonably be understood that way.
` Q. Yeah.
` A. Certainly, there was substantial evidence to
` support the Board's finding. Paragraph 51 of Baccelli --
` Baccelli's been talking about these two spikes. The two
` spikes, 24, that earlier at paragraph 44 are described as
` symmetrically disposed to each other across the sagittal
` plane. In Figure 2 of Baccelli, it clearly shows the
` spikes, 24, at the middle --
` Q. Not -- not to beat a dead horse, but where does
` the Board say precisely that Baccelli -- where is that
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` fact finding? Is this all captured in the we don't find
` Petitioner persuasive sentence? Or is there actually a
` fact finding somewhere in the opinion about Baccelli?
` Because I agree with you, there is substantial evidence
` in Baccelli for such a fact finding. I'm just curious
` where the -- is it -- is it really all that one sentence?
` A. Your Honor, it's not one sentence. It's the
` whole two pages read in context ---
` Q. Where -- but where does it mention Baccelli?
` A. I -- I believe it does cite Baccelli.
` Q. On page 11. We --
` A. Yes.
` Q. -- do not find patent owner's argument
` persuasive. As Petitioner notes, Baccelli teaches the
` use of radio markers in the central regions of an
` implant.
` A. Yes.
` Q. So that sounds like a fact finding, right?
` A. Yes, and it --
` Q. It sounds like a very precise fact finding.
` A. It cites to paragraph 51 of --
` Q. Yeah.
` A. -- Baccelli. That's the paragraph that talks
` about making the two markers -- to the two spikes 24
` radiopaque.
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`Page 19
` Q. Okay. See, that -- that feels good to me. That
` feels like a fact finding. Very precise.
` Q. And then there's the motivation question.
` A. The -- the question of motivation to combine?
` Or motivation --
` Q. No, why -- why somebody would have -- would have
` gone about -- there's no question -- this is a fact
` finding that says Baccelli has this.
` A. Um-hum.
` Q. But why would somebody have --
` A. You know, the origin of the motivation begins
` just a paragraph earlier in Baccelli. In paragraph 50,
` stretching across pages 750 to 51 of Baccelli talks about
` two other radiopaque markers 47. And it notes that using
` radiopaque markers helps you understand the position and
` location of the implant, both before and after surgery.
` In the next paragraph, it says you can also put the
` markers in the middle. But as general teaching about the
` value of radiopaque markers should at least carry over to
` the next paragraph. They're being used there for the
` same purpose. NuVasive's only argument in response is,
` oh, that's too many markers. You know, it's too
` confusing. But the Board didn't credit that argument.
` It says, you know what, these spinal surgeons, we're
` think they're -- they're smart guys. A guy of ordinary
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`Page 20
` skill would have known not to use too many markers. And
` if markers at the ends show you position and orientation,
` that's what markers do generally. And markers at the
` middle can show you the same thing. In their -- in their
` reply -- in their --
` Q. Is there anything further you want to add, Mr.
` Matal?
` A. I yield the floor.
` Q. Thank you. We got your argument. Thank you
` very much. It's very helpful to have the PTO stand in in
` this instance when we didn't have a brief person anymore.
` So thank you for doing that.
` You have some rebuttal time.
` MR. ROSATO: Thank you. I'm just going to make
` one comment on the Baccelli reference. Sorry, I'm
` Italian. I have to pronounce it. So -- so -- and that's
` not my only comment. So on the teachings of Baccelli, I
` want to make clear -- so while the Board may have assumed
` that Baccelli is teaching these markers in the medial
` plane, we disagree with that interpretation, obviously.
` And the more pertinent point is the Board's relying very,
` very heavily on Baccelli and almost exclusively, if you -
` - depending on how you read their reliance on -- on the
` Yuan testimony. But the rationale, according to the
` Board's decision, comes entirely from Baccelli.
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`Page 21
` So taken in that context, you would expect to
` see some generalized teaching about the benefits of
` markers in this position -- in these positioning across a
` range of implants. But that's -- that's not a teaching
` that's found. And there is no fact finding on that
` point.
` Q. Well, assume for purposes of this question that
` the Board found and could find based on paragraph 51 of
` Baccelli that Baccelli discloses making the medial spikes
` radial. What is left of the -- what still needs to be
` shown or found by the Board for the obviousness case?
` A. Sure. Why you would look to a horseshoe type
` cervical implant, assuming your facts, Your Honor.
` Q. Yes.
` A. Why would you -- why you would look to a
` horseshoe-shaped cervical implant --
` Q. That's Baccelli.
` A. -- one part of the spine of Baccelli and take
` that same type of design or take that specific design,
` apply it to a different type of implant that goes in
` posteriorly in the lumbar region, there's no reason why.
` Q. So there's still -- there's still a -- an
` additional need for a motivation to combine even what is,
` by assumption, found in Baccelli with the -- this is,
` what, SVS again?
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`Page 22
` A. SVS and Telamon, yes. Exactly. So even if one
` were to assume Baccelli teaches those markers, why you
` would take that design feature and apply it to a
` different -- very different type of implant --
` Q. So -- so tell -- to get back to the -- the
` place, I guess, at A-9, page 9 of the Board's decision,
` where it is reciting the Petitioner's argument based on
` paragraph 68 opines -- that's A-591 -- and not really
` using the -- not, in fact, using the language of finding.
` How do we think about whether, as I think Mr. Matal
` suggests, we can say what they were doing here was
` effectively making the finding because they're saying
` here's what it is. You have one response to it. We're
` not persuaded by the response. And instead of -- and
` they should have written a sentence that we, therefore,
` credit Petitioner's position. They didn't put that
` sentence in. What -- is it -- is it really a doubt about
` what they meant there?
` A. I think -- I think there's not a doubt that they
` weren't crediting that argument. They were coming back
` to Baccelli and saying Baccelli, Baccelli, Baccelli. You
` know, NuVasive, it's fine you argue this, but there's
` Baccelli. And you can see this at A-11 through A-13 in
` multiple instances they -- to address arguments that were
` raised, they come back to Baccelli and say, well, you
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`Page 23
` argue that, but Baccelli teaches markers in the medial
` plane. You argue confusion. But Baccelli teaches -- you
` know, you argue there's no reason to do this, but
` Baccelli teaches. So again, this comes back to, well,
` what does Baccelli teach. What it doesn't have is some
` generalized teaching that, you know, this is a wonderful
` feature to apply across a wide range of different types
` of implants. In fact, we don't think they show in even
` theirs.
` Q. Okay, thank you, Mr. Rosato. The case is --
` (End of recording)
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`CERTIFICATE
`
`Page 24
`
`I, Wendy Sawyer, do hereby certify that I
`transcribed the electronic recording; and that the
`foregoing transcript is a true transcript of said
`electronic recording to the best of my ability.
`I further certify that I am not a relative,
`employee, attorney, or counsel of any of the parties, nor
`am I a relative, employee, attorney, or counsel of any of
`the parties, nor am I a relative or employee of any of
`the parties' attorney or counsel connected with the
`action, nor am I financially interested in the action.
`
`DATED this 19th day of March, 2019.
`
`Wendy Sawyer, CDLT
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