[00:00:00] Speaker 05:
18-1839, Henry Nuvacep, Inc., and again Mr. Rosato.

[00:00:13] Speaker 00:
Thank you, and may it please the Court.

[00:00:16] Speaker 00:
There's a fair amount of overlap between issues, between what we just discussed in these cases, so I will try to avoid repeating myself on some issues, instead focus on some of the issues that are particularly unique

[00:00:29] Speaker 00:
to these two cases.

[00:00:30] Speaker 01:
But we don't have anything about lateral in these.

[00:00:33] Speaker 00:
Well, we do, Your Honor.

[00:00:34] Speaker 00:
In the 356 patent case, it specifically recites the same type of lateral transsoas.

[00:00:41] Speaker 00:
The systems claim, right?

[00:00:42] Speaker 00:
It's a system claim.

[00:00:44] Speaker 00:
So there is a claim construction issue there, and it ties more directly into the rationale to combine issue.

[00:00:50] Speaker 00:
So the two tie together.

[00:00:51] Speaker 00:
But as an initial matter, it's worth pointing out that in the context of construing the term lateral transsoas approach to the spine,

[00:00:58] Speaker 00:
Here, the board never offered any construction for what lateral transo is meant.

[00:01:03] Speaker 00:
The only thing that it stated about claim construction is that that term is a statement of intended use and entitled to no weight other than defining the system and its components as being suitable for that type of use.

[00:01:16] Speaker 00:
Capable.

[00:01:16] Speaker 00:
Yeah, capable for that type of use.

[00:01:20] Speaker 00:
And we generally agree with that.

[00:01:21] Speaker 00:
But there are consequences that flow from that construction.

[00:01:24] Speaker 00:
That include at least one, why?

[00:01:27] Speaker 00:
person of ordinary skill would put these components and prior references together in that manner.

[00:01:33] Speaker 00:
If it's not for the stated intended use in the claim, what is the purpose?

[00:01:40] Speaker 00:
And then two, this capable of use for.

[00:01:43] Speaker 00:
That is an aspect for rationale that is completely unaddressed in both the petition and the board's final written decision.

[00:01:53] Speaker 00:
So the two rationale issues tie together.

[00:01:56] Speaker 00:
There's a broader issue for rationale that traces throughout the cases.

[00:02:00] Speaker 00:
And that ties to the fundamental misapprehension of the references upon which the petitions were constructed.

[00:02:08] Speaker 00:
What I mean is the open chain reference was assumed to be a lateral approach going through the nerve rich region of the psoas.

[00:02:16] Speaker 00:
The stated rationale was you would want nerve monitoring to navigate through that.

[00:02:21] Speaker 00:
Now, that's wrong for two reasons.

[00:02:23] Speaker 00:
One, the state there at the time taught that that nerve rich region was perceived as a... Can I just stop?

[00:02:30] Speaker 01:
Because I guess it seemed to me that you're... Just tell me why I've missed something about the way you've conceived of your case.

[00:02:42] Speaker 01:
Right at the core of your case on the system,

[00:02:45] Speaker 01:
claims is the proposition that nobody would have been sufficiently motivated to put the electrical sensing on the inserted devices unless they were planning to go through the nerve-rich region of the psoas.

[00:03:03] Speaker 01:
And it seemed to me that the board cited and the director in the green brief

[00:03:09] Speaker 01:
in support of the board cited still more evidence that that's just not true.

[00:03:16] Speaker 01:
There were other motivations to make that combination.

[00:03:21] Speaker 01:
And if you make the combination and all you have is a capability reference to use, then you're there.

[00:03:31] Speaker 01:
So why is the director wrong in saying,

[00:03:37] Speaker 01:
The board found, wholly independent of Obenchain, based on, I know, Marino, Kelleher, a few different things, there was motivation to put the electrical sensing on the insertion devices, let's call them.

[00:03:51] Speaker 00:
Sure.

[00:03:52] Speaker 00:
So first, as patent owner in any of these proceedings, our initial task is responding to the petitioner's stated case and addressing whether they met the burden of proof.

[00:04:03] Speaker 00:
So here, the petitioner has specifically advanced as their rationale

[00:04:07] Speaker 00:
that rationale being to traverse through the nerve at region.

[00:04:10] Speaker 00:
So in addressing that stated rationale and the only stated rationale, it was demonstrated that one, that is not an accurate reflection of the state of the art at the time.

[00:04:19] Speaker 00:
The state of the art reviewed that area of the body as not an area that could safely or predictably be traversed without any of the technology that was available at the time.

[00:04:30] Speaker 00:
So that was the state of the art on that issue.

[00:04:32] Speaker 00:
As for any altered, oh, and then the other point on that is

[00:04:37] Speaker 00:
their interpretation of Obanchain, that was the reference that the petition was pointing to as the reference teaching the surgical path.

[00:04:45] Speaker 00:
So they're saying, follow the surgical path of Obanchain, it leads you through here.

[00:04:48] Speaker 00:
So responding to that is demonstrating that their case was built on a false premise.

[00:04:55] Speaker 00:
So that's one response.

[00:04:55] Speaker 04:
But putting Obanchain aside though, as Judge Toronto said, I mean, Kelleher and Moreno are pretty powerful references because they say,

[00:05:05] Speaker 04:
You know, this is useful for any surgery because there's always nerves and especially if you're going at the spine.

[00:05:12] Speaker 04:
And they don't say whether you're going at the spine through the stomach or through the back or through the side.

[00:05:18] Speaker 04:
They say anytime you're going at the spine, you need to be worried about nerves.

[00:05:23] Speaker 04:
So just because some regions are more nerve rich than others doesn't mean that it's not teaching that you would use this

[00:05:31] Speaker 04:
device.

[00:05:32] Speaker 00:
Yeah.

[00:05:32] Speaker 00:
So again, two responses.

[00:05:33] Speaker 00:
One, coming back to the stated rationale, and two, that characterization, which I think you accurately recited, the board's characterization, I would just take issue with that actual characterization.

[00:05:45] Speaker 00:
I would like to get into that.

[00:05:46] Speaker 04:
But the stated rationale... Well, I know I accurately characterized the board, but I actually read the references, and that's what they said.

[00:05:52] Speaker 00:
Well, they don't say anything about the psoas muscle, and the board... Right.

[00:05:55] Speaker 04:
They'd say any time you're going toward the spine, there's going to be lots of nerves.

[00:05:59] Speaker 00:
They say any...

[00:06:00] Speaker 00:
when you're going toward the spine and you're traversing tissues that include lots of nerves.

[00:06:05] Speaker 00:
But that is true in some approaches to the spine and not others, especially when you're talking about motor neurons and even when you're getting into the psoas muscle.

[00:06:15] Speaker 00:
There's undisputed point made and evidence to support it that even in the psoas muscle, the anterior portion lacked the sensitive motor neurons that were being traced and of a concern.

[00:06:28] Speaker 00:
There's a Morrow paper in the record, and I can find you the A site, that maps the neural anatomy of the psoas muscle and specifically characterizes the anterior portion as a safe zone where nerve damage is not of concern.

[00:06:44] Speaker 00:
So that's what the psoas muscle, what the interior approach, again, these are the access issues that come up and drive these types of surgeries.

[00:06:53] Speaker 00:
An anterior approach has access issues.

[00:06:56] Speaker 00:
Those issues relate entirely to organs, blood vessels, bowels, have nothing to do with nerves.

[00:07:03] Speaker 00:
So nerves are not a, they are not, I mean, anytime you're dealing with the spine, you've got a spinal cord, but in terms of the access.

[00:07:11] Speaker 05:
Excuse me?

[00:07:13] Speaker 00:
Nerve monitoring is not used in anterior approaches.

[00:07:19] Speaker 00:
There are blood vessels you have to watch out for, you have to be careful, bowel perforation and so forth.

[00:07:26] Speaker 00:
but a nerve monitoring is not something that is a concern.

[00:07:31] Speaker 04:
Yes, it's possible that some surgeons don't do belt and suspenders in certain types of surgery, but the reference teaches that it would be useful for any time you're going near the spine just to be safe.

[00:07:46] Speaker 00:
When going through nerves having sensitive tissues, and every one of the citations that the board provides

[00:07:53] Speaker 00:
to, you know, blue it, for example.

[00:07:55] Speaker 00:
Blue it refers to tissues having nerves which, if impinged, could cause damage.

[00:08:03] Speaker 00:
The Kelleher reference has similar statements and the remaining one, what is it, the... Marino?

[00:08:10] Speaker 00:
Yeah, Marino.

[00:08:11] Speaker 00:
Well, and Marino's a great example, right?

[00:08:14] Speaker 05:
I'm sorry, I'm not following.

[00:08:16] Speaker 05:
I mean, the patent shows going through at least part of the psoas, right?

[00:08:22] Speaker 05:
And there are nerves in there.

[00:08:26] Speaker 05:
And so why isn't the board correct that to do that, you would want to be a nerve monitor?

[00:08:33] Speaker 00:
When you say the patent, are you referring to the open chain patent?

[00:08:36] Speaker 00:
Your patent.

[00:08:37] Speaker 00:
Oh, yes.

[00:08:37] Speaker 00:
Our patent certainly teaches that.

[00:08:39] Speaker 00:
But if the board's relying on that, obviously that's in proper hindsight.

[00:08:43] Speaker 00:
Now, as far as the state.

[00:08:44] Speaker 05:
No, but what it's teaching is going through at least part of the psoas muscle.

[00:08:52] Speaker 05:
That's what you're going to do.

[00:08:54] Speaker 05:
You would use nerve monitoring, wouldn't you?

[00:08:57] Speaker 00:
According to our patent, yes, in terms of rationale to combine the prior reference.

[00:09:02] Speaker 05:
What about on Merino?

[00:09:03] Speaker 05:
Wouldn't Merino teach you to do that?

[00:09:05] Speaker 05:
To go through the psoas?

[00:09:06] Speaker 05:
No, if you were going to go through part of the psoas to use nerve monitoring.

[00:09:11] Speaker 00:
It absolutely would not teach you that.

[00:09:13] Speaker 00:
Why not?

[00:09:13] Speaker 00:
Think about the Merino, because the Merino divide, first that says nothing about the psoas muscle.

[00:09:19] Speaker 00:
Two, the way the device is constructed in no way

[00:09:23] Speaker 00:
Is it possible to use that device in navigating the psoas?

[00:09:26] Speaker 00:
Reno has an expandable pedal distal tip that's designed to, when you contact a nerve, mobilize it out of the way.

[00:09:35] Speaker 00:
One of the unique aspects of the psoas muscle is those nerves aren't easily mobilized and they have to be navigated through.

[00:09:43] Speaker 00:
So how a person would be able to use that expandable tip without completely shredding the psoas muscle, I have no idea.

[00:09:51] Speaker 00:
But that's something, I mean, these are the things that aren't explained.

[00:09:53] Speaker 00:
And that gets to the capable of issue.

[00:09:57] Speaker 00:
And that issue traces throughout both with the nerve monitoring references like Marino, but also the retractor systems like Coros, right?

[00:10:06] Speaker 00:
Coros is a retractor system having large flanged blades to hold organs out of the way.

[00:10:11] Speaker 00:
How you would advance that through the psoas muscle without completely destroying it is not apparent or explained anywhere.

[00:10:21] Speaker 00:
So there is this rationale issue with patentable weight and a lack of explanation how these things get there.

[00:10:30] Speaker 00:
There's a claim mapping, but it's a rationale.

[00:10:34] Speaker 01:
Can I just ask, for purposes of this question, just assume for a minute that Moreno and Kelleher motivated a relevant skilled artisan to put

[00:10:49] Speaker 01:
the electrical sensing equipment on a system of nested dilators, cannulas.

[00:10:59] Speaker 01:
Did you have evidence that if that structure were created, it would not be capable of a trans-soas approach?

[00:11:11] Speaker 00:
Uh, no, but I would say that's not the patent owner's burden to do that, Your Honor.

[00:11:17] Speaker 00:
And we were criticized by the board on that basis.

[00:11:21] Speaker 01:
But in the context of rationale... It may try to have evidence that once you had that, you know, electrified dilator system, it would be capable of... Let's assume now it was, you know, a

[00:11:39] Speaker 01:
a lateral transfer for one of these two cases.

[00:11:42] Speaker 00:
So for particularly the dilators, I think the extent of their argument was these are all in the same art.

[00:11:48] Speaker 00:
This is analogous art and you could have done this.

[00:11:52] Speaker 00:
Where I think they're showing and the boards is particularly lacking is when it comes to the retractor systems.

[00:11:58] Speaker 00:
There is absolutely no description of what modifications would need to be made, how those would be done, and why somebody would do that.

[00:12:06] Speaker 00:
Again, this is

[00:12:08] Speaker 00:
I've got three minutes.

[00:12:10] Speaker 00:
If I may, I want to answer your question.

[00:12:12] Speaker 00:
I do want to hit the objective evidence, which are very important throughout all of these cases.

[00:12:21] Speaker 00:
But it ties into some of these very same considerations we're talking about for motivation.

[00:12:27] Speaker 00:
You can do what the board did, which is go find the elements and ask why not.

[00:12:32] Speaker 00:
There is one.

[00:12:38] Speaker 00:
shouldn't be in a position of really having to answer that without being the party without the burden of proof.

[00:12:42] Speaker 00:
But the objective indicia, that is the type of evidence that's supposed to address that type of why not question.

[00:12:51] Speaker 04:
Are you contending that the XLIF procedure is the invention that is disclosed in the patents?

[00:13:02] Speaker 00:
It is, without dispute, an embodiment in

[00:13:07] Speaker 00:
every single one of the claims of the four different patents.

[00:13:12] Speaker 04:
But, I mean, how can that be if at times that procedure doesn't include cannulated devices with no monitoring?

[00:13:22] Speaker 00:
So the core components of the XLIFT system are a transo's approach using sequential dilators stimulated with a corresponding

[00:13:35] Speaker 00:
retractor system over it.

[00:13:36] Speaker 00:
Those are all core components of all of the claims.

[00:13:40] Speaker 00:
So, and again, this was not a point of dispute.

[00:13:43] Speaker 00:
Neither Medtronic nor the board ever dispute that EXLAF fell within the scope of the claims.

[00:13:48] Speaker 00:
And this is one of the fundamental issues, gating issues and errors for the board's treatment of the secondary considerations.

[00:13:55] Speaker 00:
This court has explained even as recently as the PPC broadband case, there are two of them, the PPC Corningware, that

[00:14:04] Speaker 00:
Once there, when evidence of objective condition is tied to a commercial product and that product is demonstrated to fall within the scope of the claim, there's a presumption of nexus, right?

[00:14:14] Speaker 04:
Well, that's the fine principle, but the problem is that it's difficult to understand whether this procedure really does fall within the scope of the claim.

[00:14:23] Speaker 00:
Well, Medtronic never had any difficulty and they never... Well, I don't care if they have difficulty.

[00:14:27] Speaker 04:
I'm having difficulty, so let's talk about that.

[00:14:31] Speaker 00:
Well, the board had difficulty some instances and they didn't have difficulty in other instances when they addressed the indicia for its knockdown value.

[00:14:44] Speaker 00:
The board's entire response was essentially to go find unclaimed features and point out that those are not expressly recited.

[00:14:53] Speaker 00:
So again, if everything that's uncontested is taken, what we're left with is the commercial embodiment falling within the scope.

[00:15:01] Speaker 00:
and nothing of rebuttal beyond saying that there are aspects of the system that aren't expressly recited.

[00:15:12] Speaker 00:
But nobody was contesting that it felt in the scope.

[00:15:15] Speaker 00:
I know there is a surgical guide that was presented just to briefly address this point.

[00:15:22] Speaker 00:
There was a declaration that was submitted.

[00:15:24] Speaker 00:
There was argument in the response discussing the essential components of the system, how they map to the claims,

[00:15:31] Speaker 00:
There was Dr. Phillips's declaration where he included a claim chart mapping all the aspects of XLIF from the XLIF surgical guide, which is a step-by-step surgical guide with pictures and illustrations, to the claims.

[00:15:49] Speaker 05:
Medtronic's expert.

[00:15:50] Speaker 05:
You're well over your time here.

[00:15:52] Speaker 05:
We'll give you two minutes for our model again.

[00:15:54] Speaker 05:
Thank you.

[00:15:57] Speaker 05:
Ms.

[00:15:57] Speaker ?:
Clavin?

[00:16:01] Speaker 03:
Thank you, Your Honor.

[00:16:01] Speaker 03:
May I please support?

[00:16:03] Speaker 03:
Starting with the motivation to combine, there is plenty of evidence in the trunnix petition there, expert and the board found in the prior art references, a motivation to combine cannulated instruments with nerve monitoring, in particular, these claim dilating cannulated instruments.

[00:16:21] Speaker 03:
And regardless of a transoas approach to the spine, there was also then evidence presented that there was a motivation to use this in a transoas approach

[00:16:30] Speaker 03:
not just over-chain, but because their Metronix expert testified that a direct lateral approach or a lateral approach to the spine is the most direct approach.

[00:16:42] Speaker 03:
So unless there's any questions about that, I will move on then to the capable of question.

[00:16:49] Speaker 03:
There seems to be some argument in their brief that there's not evidence that these instruments are capable of going through a direct lateral approach to the spine.

[00:17:01] Speaker 03:
There was no, they never presented any of this evidence to the board.

[00:17:06] Speaker 03:
And the board found that there's no evidence that it wouldn't be capable of the direct lateral approach.

[00:17:12] Speaker 01:
And all this is- What about on the affirmative side of the ledger?

[00:17:16] Speaker 03:
So I don't think there's any evidence on the metronic side that they were or were not.

[00:17:20] Speaker 03:
There was just, you would be a motivation to confine in the general, I think, agenda.

[00:17:24] Speaker 01:
But if the claim is construed to require capability, then need not there be?

[00:17:31] Speaker 01:
affirmative evidence that that requirement is met, namely that there was such capability?

[00:17:36] Speaker 03:
I think they said that it was capable of, but they didn't say... Who said?

[00:17:40] Speaker 03:
Metronix, sorry.

[00:17:41] Speaker 03:
Metronix said it was, you know, that they construed the claim as an intended use for the lateral transsous approach and that there was a motivation to combine these particular instruments and they would be capable of going through the direct lateral approach.

[00:17:55] Speaker 04:
But where's the capability evidence, though?

[00:17:57] Speaker 02:
So I think, I don't think it was

[00:17:59] Speaker 04:
Is it just an argument?

[00:18:00] Speaker 02:
It was just an argument, but then... Well, why is that enough if they have the burden of proof?

[00:18:06] Speaker 03:
Well, they had the burden of proof that all these things of motivation combined it and it would be capable of it.

[00:18:10] Speaker 03:
And they didn't... New Basis didn't make any argument that it wasn't capable.

[00:18:14] Speaker 03:
Wait, wait, wait.

[00:18:14] Speaker 04:
The petitioner has the burden of proof.

[00:18:16] Speaker 03:
That's right.

[00:18:16] Speaker 04:
And as the Supreme Court said, if the petitioner falls out, then the board has the burden of proof on this issue, on this particular type of issue.

[00:18:24] Speaker 04:
So where is the affirmative

[00:18:27] Speaker 04:
evidence of capability.

[00:18:28] Speaker 04:
You can't just say, well, I can strew that as a capability phrase and not have any evidence, affirmative evidence of the capability.

[00:18:37] Speaker 03:
I think that there was, the evidence was essentially that all these references talk about generally using it to, for lumbar spinal surgery, the minimally invasive instruments and the nerve monitoring and that it would be capable then of any of those approaches.

[00:18:56] Speaker 03:
I don't know what more they could have, you know, what particular evidence they could have said beyond, you know, when we combine these instruments.

[00:19:03] Speaker 03:
But there was expert testimony?

[00:19:05] Speaker 03:
There was expert testimony of a motivation to combine these and to use them in a direct lateral approach.

[00:19:12] Speaker 03:
There wasn't any particular testimony about in order to do the specific transoas you would need to make any different modification.

[00:19:20] Speaker 03:
And there's nothing in their patent that suggests there's some specific

[00:19:24] Speaker 03:
structure about these dilating cannulas and neuromodulation that require a different physical form than if you would use it in any other approach to the spine?

[00:19:35] Speaker 01:
What evidence are you referring to specifically about motivation to use these electrified dilators in a direct lateral approach?

[00:19:47] Speaker 03:
So let's see.

[00:19:53] Speaker 01:
Which appendix are we looking at?

[00:19:55] Speaker 03:
So I'm in the 1839 appendix.

[00:20:02] Speaker 03:
And this is Watkins' testimony.

[00:20:08] Speaker 03:
There's testimony at 1204, A1204, about combining them, combining, specifically this was the Keller and the Sistak reference.

[00:20:25] Speaker 03:
And I think that I don't think the evidence was any different in for these system claims than the method claims.

[00:20:31] Speaker 03:
I mean, it was talking about a motivation to combine tellers using their.

[00:20:36] Speaker 01:
Right.

[00:20:37] Speaker 01:
I guess I just want to focus on this because it's at least possible to view of the method claims.

[00:20:45] Speaker 01:
One of them, they didn't do a claim construction thing.

[00:20:47] Speaker 01:
So we can forget about the problem.

[00:20:49] Speaker 01:
If there is one of lateral, the other one, there may be a problem of lateral.

[00:20:54] Speaker 01:
Now we're in the system claims.

[00:20:56] Speaker 01:
One of them has a lateral and the other one doesn't have a lateral, but they both have a capability.

[00:21:01] Speaker 01:
And so there has to be evidence.

[00:21:02] Speaker 01:
We didn't need to talk about it on the method, the two method patents.

[00:21:07] Speaker 01:
So I guess I really am interested in the specific evidence that when, when you create this apparatus, it is capable of being used.

[00:21:17] Speaker 01:
Maybe that's inferrable from.

[00:21:19] Speaker 01:
you have a motivation to use it.

[00:21:21] Speaker 01:
But I guess I want to see what the evidence is.

[00:21:24] Speaker 03:
Okay, so let's go to A 1198.

[00:21:26] Speaker 03:
This is a little earlier in Watkins' testimony, I mean, declaration.

[00:21:32] Speaker 03:
And it's at paragraph 37.

[00:21:37] Speaker 03:
And it's, this is talking about the motivation to use the combination

[00:21:45] Speaker 03:
in a direct lateral transsous path.

[00:21:48] Speaker 03:
It's the most direct approach to the spinal disc in the anterior column of the spine.

[00:21:54] Speaker 03:
And it has advantages over the anterior and posterior approaches.

[00:21:58] Speaker 03:
So that was testimony that once you had a motivation to combine the particular instruments, that you would be motivated to use it in the direct lateral approach.

[00:22:08] Speaker 03:
There wasn't any specific testimony or statement or declaration statements about

[00:22:15] Speaker 03:
any particular structure that you would need to make this for the direct lateral approach as opposed to any different approach.

[00:22:22] Speaker 03:
And there's nothing in their patent that suggests that there needs to be a specific structure.

[00:22:27] Speaker 01:
And they didn't, and New Vesa didn't present, didn't sort of contest the proposition, didn't say, well, even if you create this structure, that's not, and even if you assume this is a mere capability, you haven't shown that that capability exists with that structure.

[00:22:45] Speaker 03:
If I understand your question, Novasiv didn't contest before the board that there was any particular structure that the motivation combined failed to meet, so that it wasn't capable of going through the direct lateral spine because the structure was X. Their argument really appeared for the first time in their reply brief here, right?

[00:23:03] Speaker 04:
That's correct.

[00:23:04] Speaker 03:
They made a few statements in their blue brief that the retractors or things wouldn't work, but it's not until the reply brief before this court where they make

[00:23:12] Speaker 03:
attorney argument about how you wouldn't be able to modify these retractors to do the direct lateral approach as opposed to different approaches to the spine.

[00:23:22] Speaker 03:
So I think the argument is waived and I think that there's nothing no testimony that was before the board or in the specification that they can point to that the combination of the prior wouldn't have been capable of doing the direct lateral approach.

[00:23:37] Speaker 04:
Let me ask you about the objective.

[00:23:40] Speaker 04:
First of all, do you concede that to the extent that the board said that you can't show long felt need without showing failure of others, that that was error?

[00:23:49] Speaker 03:
To the degree that they were making a legal statement that failure of others required, that long felt need required failures of others, yes, that is incorrect.

[00:23:59] Speaker 03:
I think that they were saying, that's not what I think they were saying.

[00:24:03] Speaker 03:
They were saying there's no evidence of a long felt need because there's all these other approaches.

[00:24:10] Speaker 03:
presented evidence, a patent by Jacobson, of a long felt need for a lateral approach to the transsous muscle.

[00:24:16] Speaker 03:
There's nothing in that patent that says, thank goodness we've got this, we've needed this for a long time, or someone needs to come up with this.

[00:24:23] Speaker 03:
All they had was, there were prior art statements, prior art patents that went through the lateral approach, didn't make a mention of the psoas muscle.

[00:24:30] Speaker 03:
So the board reasonably found- That was a loose statement that you would have greased

[00:24:35] Speaker 04:
at least on its face, appears incorrect, but you don't think it changed the validity of the analysis?

[00:24:40] Speaker 03:
That's right.

[00:24:40] Speaker 03:
I think it would be harmless error if they did make that incorrect legal statement.

[00:24:45] Speaker 03:
When they made that site, they also then had a parenthetical from another case saying, just because there's a long time where no one's come up with this reference, isn't it self-sufficient to show a long-felt need

[00:24:56] Speaker 03:
I think that's what they were getting at.

[00:24:58] Speaker 03:
You're not pointing to me to anything or anyone saying, we need this lateral approach, as opposed to there's problems with the other approaches.

[00:25:06] Speaker 03:
And then, in the absence of that, there's nothing that shows this failure of others, which would indicate that someone was trying this.

[00:25:15] Speaker 03:
So I think it would be harmless error.

[00:25:17] Speaker 04:
What's your response to that X-L-I-F?

[00:25:19] Speaker 04:
I understood that the board said there's just really insufficient evidence that

[00:25:25] Speaker 04:
it practices the claims.

[00:25:27] Speaker 04:
Your friend on the other side is saying, no, there really was no dispute that it practices the claims.

[00:25:32] Speaker 04:
So what's your response to that?

[00:25:34] Speaker 03:
The board said that that evidence first wasn't correctly incorporated into their response.

[00:25:38] Speaker 03:
The claim chart, everything was outside the brief and they didn't properly make the argument in the patent owner's response.

[00:25:45] Speaker 03:
The board also then went on

[00:25:47] Speaker 03:
and to say that even if, despite the procedural infirmity, there's no evidence about what this Excel system is.

[00:25:55] Speaker 03:
If you look at what the expert was pointing to, there's this max access system.

[00:26:01] Speaker 03:
And then xLIFT seems to be a subset of tools within then using these max access and neuromodulation systems to do the xLIFT procedure.

[00:26:14] Speaker 03:
And so we're not exactly sure what this xLIFT

[00:26:18] Speaker 03:
system is, and it appears that, in fact, to the extent you're saying there's all this praise and success arising from it, it looks like that's the max-axis system.

[00:26:28] Speaker 03:
That's where the dilating cannulators are, and it's the neuromodulation system.

[00:26:34] Speaker 03:
So it wasn't clear to them what this X-left system was, and that there wasn't a broader product of

[00:26:44] Speaker 03:
spine surgery systems, that the X-Lift system was just one system in the back.

[00:26:50] Speaker 01:
I'm sorry, what evidence is there that this X-Lift system is something other than the combination of the nested dilators and the electrical sensing put together?

[00:27:04] Speaker 03:
Their brochure has the X-Lift system as a number of different instruments that are none of those.

[00:27:13] Speaker 01:
What else?

[00:27:14] Speaker 03:
What else is in there?

[00:27:17] Speaker 03:
Let's see.

[00:27:18] Speaker 03:
I don't think I have it marked in this.

[00:27:22] Speaker 03:
Oh, here it is.

[00:27:24] Speaker 03:
The Max Access system is, and with the different xLIFT instruments, is at a 15,897.

[00:27:46] Speaker 03:
And that's where, so that's the instrument system.

[00:27:49] Speaker 03:
And none of those, I mean, there's a number of different things, chords and sizers, and maybe the distractor is what's used and is part of the claim.

[00:28:00] Speaker 03:
But in the next page, then you have the general instrument system.

[00:28:04] Speaker 03:
And then it's not till you get to 15.901 where you're talking about the max access system that you have the dilators,

[00:28:15] Speaker 03:
and the KYR and those aspects.

[00:28:18] Speaker 03:
So I think what the board is saying is it is disputed what these components are in terms of what they are as the XLIFT system.

[00:28:28] Speaker 03:
And when you refer to the XLIFT system, what you are referring to.

[00:28:32] Speaker 03:
But beyond that, the board said even if there's no presumption of nexus, these are clearly components of a larger system.

[00:28:40] Speaker 03:
So there should be no nexus of the success.

[00:28:42] Speaker 03:
And there was rebuttal evidence anyway

[00:28:45] Speaker 01:
Can I ask you something about Nexus?

[00:28:49] Speaker 01:
I'm not remembering precisely enough.

[00:28:51] Speaker 01:
I thought I was remembering, or I think I'm remembering, that the board said something like the following.

[00:28:57] Speaker 01:
You can't have Nexus based on a use if there are a whole bunch of other uses.

[00:29:03] Speaker 01:
Use of a system and now product and a thing as opposed to a series of steps.

[00:29:08] Speaker 01:
And I guess I started being troubled by that.

[00:29:12] Speaker 01:
Suppose you had a

[00:29:14] Speaker 01:
pharmaceutical composition, claim to the composition.

[00:29:17] Speaker 01:
And it's put out on the market for the one FDA cleared use that makes it extremely attractive.

[00:29:26] Speaker 01:
And the market goes wild.

[00:29:28] Speaker 01:
That evidence surely counts as legitimate commercial success evidence on an obvious as inquiry where there may be prior at that's really close, even though as is also common, other uses of the very same molecule

[00:29:44] Speaker 01:
may be around.

[00:29:47] Speaker 01:
So I guess the idea that you can't establish nexus by pointing to one of a number of uses seems, I don't know, overbroad.

[00:29:59] Speaker 01:
Can you help me on that?

[00:30:03] Speaker 03:
I hope this is helpful.

[00:30:04] Speaker 03:
I think what it is is, yes, that pharmaceutical composition, everyone says it's used for whatever it does.

[00:30:12] Speaker 03:
is because of what is claimed, then we have no doubt that that... It's the thing.

[00:30:16] Speaker 03:
It's the thing.

[00:30:17] Speaker 03:
But if the evidence... But why?

[00:30:19] Speaker 01:
Why?

[00:30:19] Speaker 03:
Because there are other uses that... Yeah, and I think that's fine that there are other uses, and to the extent the board was saying because there's other uses.

[00:30:25] Speaker 03:
I don't read the board saying that, but I think it's fine if it had other uses.

[00:30:29] Speaker 03:
If people's compliments or their praise and their success turn out because the drug is formulated with magnesium... I was just focusing on...

[00:30:42] Speaker 01:
I mean, it does seem to me that our little litany of secondary considerations maybe puts things in segregated boxes more than it should, but just focusing on commercial success.

[00:30:54] Speaker 01:
Turns out, as soon as this was available on the market, a whole lot of surgeons thought this is a good option to have, and a bunch of them started using it.

[00:31:05] Speaker 01:
And they knew that there were problems with the other approaches, not ones that would lead you always to use this one, but in a lot of cases.

[00:31:12] Speaker 01:
that tells you there was an interest in achieving this ability.

[00:31:18] Speaker 01:
And if it were simple, obvious, it would have been done before.

[00:31:23] Speaker 01:
That's the kind of simple, logical relevance of evidence of this sort.

[00:31:27] Speaker 01:
So just on this kind of commercial success, why can the board, if it did here, focus on

[00:31:37] Speaker 01:
the failure to discuss other possible uses when one use of this system turns out to have been of quite considerable interest in the medical community?

[00:31:47] Speaker 03:
I think to the extent there was a failure to discuss other uses, that's wrong.

[00:31:52] Speaker 03:
Because if there are other uses of it, that's fine.

[00:31:55] Speaker 03:
I think the nexus problem comes in, it's when the doctors are talking about, I used this, and it's so great, and I chose it, it's they're saying,

[00:32:05] Speaker 03:
The neuromodulation system is direct, real-time, automated, our proprietary software.

[00:32:12] Speaker 03:
That's what they're praising.

[00:32:13] Speaker 03:
And that's not tied to the claim.

[00:32:16] Speaker 03:
So it's not that there's other uses that haven't been shown or looked at.

[00:32:21] Speaker 03:
It's that the praise that that product is getting is not then tied back to the claims.

[00:32:29] Speaker 03:
And that's, I think, the nexus problem that the board was focusing on.

[00:32:33] Speaker 03:
So it would have been fine if doctors were saying,

[00:32:35] Speaker 03:
This is amazing.

[00:32:36] Speaker 03:
We can now go through the trans-soas from any approach, and we've never been able to do that safely and effectively before.

[00:32:43] Speaker 03:
And it's just because of the neuromodulations with the dilating cannulas.

[00:32:47] Speaker 03:
But if they were saying it's because they have this new proprietary software, then that's the problem, where the nexus is lost.

[00:32:53] Speaker 03:
I hope I've answered yours.

[00:32:54] Speaker 03:
I'm over my time.

[00:32:55] Speaker 03:
Thank you.

[00:32:56] Speaker 00:
Thank you, Your Honor.

[00:33:05] Speaker 00:
Thank you.

[00:33:07] Speaker 00:
So on Exliff, I just want to clarify something in the record.

[00:33:13] Speaker 00:
There was no fact finding by the board that Exliff did not fall within the scope of the claim.

[00:33:18] Speaker 00:
So there was no finding on that.

[00:33:20] Speaker 00:
Dr. Phillips submitted his... But there was a finding that they couldn't tell, right?

[00:33:25] Speaker 00:
There was a complaint that it wasn't easy enough for them to tell.

[00:33:29] Speaker 00:
I'm not clear

[00:33:31] Speaker 00:
that they went as far as to say they couldn't.

[00:33:34] Speaker 00:
I don't think they did.

[00:33:35] Speaker 00:
Actually, let me say that unequivocally.

[00:33:37] Speaker 00:
They did not find they were unable to determine that.

[00:33:39] Speaker 00:
They complained that it wasn't that this whole claim chart in Dr. Phillips's explanation, which by the way is evidence, not argument, was not bodily incorporated in the brief enough.

[00:33:52] Speaker 00:
And then they said besides that, and they went on to commit legal errors as to why they weren't going to consider that.

[00:34:00] Speaker 00:
But there's no finding of fact that XLIF didn't fall within the scope of the claim.

[00:34:04] Speaker 00:
That was described.

[00:34:05] Speaker 04:
It says it appears from this evidence, and they just were listing all the discussion about neurovision and the MAC system.

[00:34:14] Speaker 04:
It says that XLIF is a marketing term that's sometimes used to identify a surgical technique and other times used to identify groups of products.

[00:34:22] Speaker 04:
Thus, when patent owner uses the shorthand term XLIF in its response, without clarifying argument, we're unable to associate patent owner's objective evidence with particular products or features."

[00:34:33] Speaker 04:
I mean, that's a finding.

[00:34:35] Speaker 04:
That's pretty clear.

[00:34:36] Speaker 00:
That they're unable to associate, but that doesn't... Okay.

[00:34:40] Speaker 00:
I understand your point, Your Honor.

[00:34:41] Speaker 04:
Right.

[00:34:41] Speaker 04:
I mean, because this is one place where the patent owner does have a burden, and that is the burden to tie the evidence of commercial success to the claims.

[00:34:51] Speaker 00:
Okay.

[00:34:51] Speaker 00:
So then I would say, I appreciate that.

[00:34:55] Speaker 00:
If that's deemed a factual finding, the question is, is it one that's supported by substantial evidence?

[00:35:00] Speaker 00:
And it's not.

[00:35:02] Speaker 00:
There is a detailed explanation in Dr. Phillips's declaration of how this all maps together.

[00:35:10] Speaker 00:
Dr. Watkins, Medtronic's expert, filed a reply brief.

[00:35:14] Speaker 00:
He testified at A3758 paragraph 7 that he understood exactly what XLIFT was

[00:35:22] Speaker 00:
and there is no dispute about ExaFall within the scope of the claim.

[00:35:26] Speaker 00:
So again, this goes back, and I agree with Ms.

[00:35:28] Speaker 00:
Craven when she says that the board's entirety of their nexus issue was an identification of unclaimed features.

[00:35:38] Speaker 00:
But going back to the PPC broadband case, that's an erroneous application.

[00:35:42] Speaker 05:
OK.

[00:35:43] Speaker 05:
I think we're out of time.

[00:35:44] Speaker 05:
Thank you, Mr. Rosano.

[00:35:45] Speaker 05:
Thank you.

[00:35:46] Speaker 05:
Thank you both, counsel.

[00:35:47] Speaker 05:
The cases are submitted.

[00:35:48] Speaker 05:
That concludes our session.