[00:00:00] Speaker 00:
The next argued case is number 17-16-66, Nubasive Incorporated against Aonfu, Mr. Asado.

[00:00:14] Speaker 01:
Thank you, Your Honor, and may it please the Court.

[00:00:17] Speaker 01:
This is an appeal from an Interparty's re-examination proceeding challenging Nubasive's 057 patent, and the obviousness combination that's asserted is based on

[00:00:30] Speaker 01:
an amalgamation of four different references without any reasonable motivation to combine.

[00:00:36] Speaker 01:
Those references are the Costman, Branch, Kelleher, and Kouros references.

[00:00:42] Speaker 01:
Motivation to combine in this case has been challenged from the beginning of the proceeding back in 2012 and has been addressed a number of times both by the examiner and by the board, and this appeal challenges the board's most recent decision.

[00:00:57] Speaker 01:
There are a number of issues raised in the briefing, and I'd like to address the subject, of course, to questions.

[00:01:03] Speaker 01:
One of the issues in particular where there seems to be no remaining dispute or at least some agreement, and that is on the issue of whether the board erred in concluding that a person of ordinary skill would have been motivated to employ the neuromonitoring of the Kelleher reference in the surgical procedure, the open surgical procedure described in the Kostman reference.

[00:01:25] Speaker 03:
That's an important issue, but could we start with claim construction?

[00:01:27] Speaker 03:
Of course.

[00:01:30] Speaker 03:
Is an evasive fine with the claim construction that this court gave for the exact same term, lateral trans-soas path, in our 2017 opinion on a different patent, but very, very closely related patent?

[00:01:49] Speaker 01:
That is an appropriate construction.

[00:01:51] Speaker 01:
I don't think that resolves all the issues in the case that relate to the claim construction, but that is an appropriate claim construction.

[00:01:59] Speaker 03:
Okay.

[00:02:00] Speaker 03:
Okay.

[00:02:01] Speaker 03:
So you're fine with that claim construction.

[00:02:02] Speaker 03:
Do you understand?

[00:02:03] Speaker 03:
Is it your view, Newvasive's view, that the claim construction as construed, it requires a path, an operative corridor through the

[00:02:17] Speaker 03:
nerve-rich portion of the psoas muscle, or not necessarily so.

[00:02:22] Speaker 03:
As long as the corridor goes through some portion of the psoas muscle, then that's fine.

[00:02:31] Speaker 01:
Well, okay, so that nerve-rich issue came up in the other proceeding for a particular reason, and I'm sure that's why you're asking.

[00:02:37] Speaker 03:
Well, I see you arguing some of that here too, which is why I'm just trying to drill down and understand what's going on here.

[00:02:45] Speaker 01:
Right.

[00:02:46] Speaker 01:
So I don't think it's necessary for this court to reach that issue and we're not asking the court to read that in.

[00:02:52] Speaker 01:
It's certainly not necessary to resolve the issues at play in the decision in front of us.

[00:02:59] Speaker 01:
And the main issue there was there's this undisputedly broad claim construction that was used throughout the board's decision and used in one instance or in one way

[00:03:10] Speaker 01:
to wipe out the examiner's factual findings on secondary considerations.

[00:03:14] Speaker 03:
So here we have a reference, Cosman, that teaches creating an operative corridor through the psoas muscle from the lateral side.

[00:03:30] Speaker 03:
So you're not arguing that portion of

[00:03:39] Speaker 03:
the board's unpatentability decision, you're arguing why, in your view, it would not be obvious to have some kind of nerve monitor to be used with Cosman's practice of going through the psoas muscle laterally.

[00:03:54] Speaker 03:
Is that right?

[00:03:55] Speaker 01:
Well, I understand your question, and it raises a couple things.

[00:03:59] Speaker 01:
So I would say, for purposes of this decision, it is not necessary to do anything with the claim construction, the board

[00:04:09] Speaker 01:
Suis Fonte proposed in its final decision, other than find consistent with this court's previous decision that it's unreasonably broad.

[00:04:19] Speaker 01:
These other issues that you're touching on are hard to answer, mainly because it's hard to see from the decision, to be honest, how exactly that construction infected the board's analysis of the prior art.

[00:04:33] Speaker 01:
I don't think it's necessary to reach that issue, because the main criticism in our

[00:04:39] Speaker 01:
view, one of the main problems with the priori combination is the motivation to combine, and there simply is none.

[00:04:46] Speaker 01:
If we were to get to that issue, I know there is some evidence and arguments submitted in the record below about a retracting procedure, a surgery of cosmen that retracts the psoas.

[00:05:01] Speaker 01:
There is some testimony about whether that would be considered.

[00:05:05] Speaker 01:
What surgeons typically refer to

[00:05:08] Speaker 01:
as, in conventional terminology, as a transsoas procedure.

[00:05:13] Speaker 01:
It gets a little dicey.

[00:05:15] Speaker 01:
I think it is not something this court needs to wrestle with, to be honest.

[00:05:21] Speaker 03:
Unless we disagree with you on motivation.

[00:05:25] Speaker 01:
Well, there are multiple reasons for motivation.

[00:05:28] Speaker 01:
But, I mean, unless you disagree with me on motivation, there's still the issue of

[00:05:35] Speaker 01:
of what did this claim construction do?

[00:05:41] Speaker 01:
That may be an issue of reversal versus remand, but to be honest, it's hard to see how this decision stands in view of the claim construction.

[00:05:50] Speaker 03:
Well, the claim construction in the 2017 evasive opinion, all it did was refine the meaning of lateral and lateral trans-soas path.

[00:05:59] Speaker 03:
I didn't see it do anything

[00:06:01] Speaker 03:
that would displace what the board said in this case about trans-SOAS path.

[00:06:07] Speaker 03:
It's really more just about the scope of lateral and it seemed like the court already last year refined and constricted the scope of lateral and that would be the only thing that would need to be touched up here with the board's construction here and I don't see how that refinement of the meaning of lateral impacts the analysis here because

[00:06:30] Speaker 03:
As far as I can tell, Cosman unquestionably goes in laterally under any interpretation of the word lateral.

[00:06:40] Speaker 01:
Well, to the original point there, even if this court disagreed and found a prima facie case, it still does infect the opinion because how does that impact the considerations of the objective indicia, right?

[00:06:56] Speaker 01:
Remember that the board here wiped out

[00:07:00] Speaker 01:
the examiner's consideration of objective indicia based on this claim construction.

[00:07:05] Speaker 01:
And that was the primary purpose of the board construing this term in its decision.

[00:07:10] Speaker 01:
So if a wholesome, obvious analysis is going to be conducted, which it should be, then that would include this situation where a prima facie case was found, yet the comprehensive analysis includes these objective indicia.

[00:07:27] Speaker 01:
So I think you understand.

[00:07:30] Speaker 01:
My point.

[00:07:32] Speaker 01:
Any further questions on the claim construction?

[00:07:34] Speaker 01:
Okay.

[00:07:36] Speaker 01:
So I do want to touch on this issue I initially raised on motivation to combine, and particularly on the board's factual findings and reasons why the Kelleher nerve monitoring system would allegedly be employed in the Cosman open surgical procedure.

[00:07:56] Speaker 01:
And here, there are a number of

[00:08:00] Speaker 01:
I'll offer an apology.

[00:08:02] Speaker 01:
There are a number of in-ray and evasive cases, and I'll try to keep them straight.

[00:08:06] Speaker 01:
But a different in-ray and evasive case, which was a precedential decision by this court, addressed the issue of clarity and specificity in an obviousness inquiry.

[00:08:20] Speaker 01:
And with regard to this issue, this stated motivation, there is not an in-ray and evasive problem in the sense that the board's reasoning in this case

[00:08:29] Speaker 01:
was very clear and very specific and the board specifically found that a person of ordinary skill would have used the Kelleher nerve monitoring system specifically to detect the iliohypogastric and the ilioenguinal nerves of cosmen and used that nerve monitoring system to detect and avoid those.

[00:08:54] Speaker 01:
The problem

[00:08:55] Speaker 01:
with that, among other things, as explained in the blue brief at pages 42 through 46, is that this is a theory that was never raised by the requester.

[00:09:05] Speaker 01:
It has no supporting evidence anywhere in the record, and it was something that was constructed or conjured by the board in its final decision.

[00:09:14] Speaker 01:
It lacks substantial evidence in the record.

[00:09:18] Speaker 01:
And there doesn't seem to be any dispute on that point.

[00:09:21] Speaker 01:
This is an issue

[00:09:23] Speaker 01:
Again, that was raised in the blue briefing, and the director chose not to defend an aspect of the decision.

[00:09:28] Speaker 01:
The director chose not to defend its briefing.

[00:09:31] Speaker 01:
It doesn't appear to be any remaining dispute on that issue.

[00:09:36] Speaker 03:
And that alone... I thought they said that there were... That your theory raised in your blue brief that this nerve monitor from Kalahir is not able to monitor these two particular nerves

[00:09:53] Speaker 03:
was not anything that you have evidence to support.

[00:09:59] Speaker 03:
I thought that's what I saw in the green brief.

[00:10:02] Speaker 01:
I think that they argued incorrectly that there was a lack of evidence on some things and that, as we pointed out in our reply, is not true.

[00:10:12] Speaker 03:
Well, where in the record is there a statement, I guess from an expert of yours, that would say definitively that when it comes to

[00:10:21] Speaker 03:
these nerves, iliohypogastric and ilioinguinal nerves, they're incapable of being monitored by Kelleher's nerve monitor.

[00:10:30] Speaker 01:
There is no evidence in the record anywhere from anyone that these two nerves can be monitored with the system of Kelleher.

[00:10:39] Speaker 01:
That's because that theory was never raised by the requester.

[00:10:42] Speaker 01:
It was never constructed by the examiner.

[00:10:44] Speaker 01:
This is something that showed up for the very first time in the board's final decision.

[00:10:49] Speaker 01:
It's pure conjecture.

[00:10:50] Speaker 01:
So from that standpoint, there is no evidence.

[00:10:56] Speaker 01:
The requester never constructed this theory.

[00:10:57] Speaker 01:
Their expert witness never constructed this theory.

[00:11:01] Speaker 01:
And indeed, it doesn't make sense.

[00:11:03] Speaker 03:
Did you ask for the board to identify this as a new ground of rejection?

[00:11:08] Speaker 01:
The board designated this as final.

[00:11:10] Speaker 01:
We didn't have the opportunity to do that.

[00:11:12] Speaker 01:
It certainly is a new ground.

[00:11:14] Speaker 01:
But we don't believe this is something

[00:11:18] Speaker 01:
that specifically warrants or we would prefer, we think the court can reach this decision rather than remanding it on the basis that there's nothing in the record on this point.

[00:11:32] Speaker 01:
So it's a factual finding that simply lacks substantial evidence.

[00:11:36] Speaker 01:
If we were to go back on remand, there's nothing further to be resolved on this point.

[00:11:41] Speaker 01:
There is evidence of record that does give some indication

[00:11:47] Speaker 01:
that I think this report would be more than capable of assessing.

[00:11:52] Speaker 01:
That illustrates that this is not, the Kelleher system is not a system that would monitor these particular types of nerves.

[00:12:01] Speaker 01:
They're identified in the Gray's Anatomy reference, which is a record.

[00:12:05] Speaker 01:
I can find the A site for you.

[00:12:07] Speaker 03:
I thought I understood the board's rationale to be repeating what the board said in its original board decision, which was basically

[00:12:18] Speaker 03:
All these references, prior art references, which talk about doing spinal surgeries, you want to make sure the tools that you're putting into the body don't touch any nerves.

[00:12:29] Speaker 03:
And so you want to have a nerve monitor connected to those tools to make sure that you know to avoid the nerves as the tools are getting closer to those nerves.

[00:12:41] Speaker 03:
And that would be an obvious thing to do for any spinal surgery, including

[00:12:47] Speaker 03:
Cosman's transzoas pathway spinal surgery.

[00:12:53] Speaker 03:
I guess I'm wondering what's wrong with that basic rationale.

[00:12:56] Speaker 01:
Okay.

[00:12:57] Speaker 01:
So in that original rationale, you've got to look at what they say.

[00:13:00] Speaker 01:
They specifically say their conclusion they draw from that initial discussion is that this is therefore allegedly simply using known methods for their established function, right?

[00:13:13] Speaker 01:
So they did say that in their first decision, and in this final decision.

[00:13:17] Speaker 03:
And they block quoted it in this decision.

[00:13:19] Speaker 01:
Exactly.

[00:13:19] Speaker 01:
And then they go on to elaborate on what they believe is the established function of Kelleher.

[00:13:24] Speaker 01:
And monitoring these two types of nerves is what they identify as the established function.

[00:13:31] Speaker 01:
This is the point of law they're trying to fit this analysis into, known things for their established function.

[00:13:37] Speaker 01:
The question is, is this the established function of Kelleher?

[00:13:40] Speaker 01:
And unquestionably, it is not.

[00:13:42] Speaker 01:
And there's simply no evidence.

[00:13:43] Speaker 01:
No substantial evidence to support that point.

[00:13:46] Speaker 01:
That is the further factual finding.

[00:13:51] Speaker 03:
I guess as a general matter, when it comes to spinal surgery, there are just nerves all over the place that you have to be very sensitive about.

[00:13:58] Speaker 01:
There are specific nerves in specific places that weren't being sensitive about in particular.

[00:14:06] Speaker 03:
And it was known that there were plenty of nerves running around in the psoas muscle.

[00:14:12] Speaker 01:
in the psoas muscle.

[00:14:13] Speaker 01:
There, Your Honor, the board found, that was part of the argument that New Base had advanced, is that these specific nerves in the psoas muscle aren't where Cosman is going, so nerve monitoring is not a concern there.

[00:14:27] Speaker 01:
The board made a factual finding on that point and agreed, and that's at, let me find you the A site, but that's at A29, the board specifically in looking at Cosman characterized

[00:14:39] Speaker 01:
Cosman as, quote, known to be capable of being performed safely in the safe zone, even without neuromonitoring, end quote.

[00:14:49] Speaker 01:
So the board, so this was part of the argument that Newvasive was advancing below, is that Cosman is going, is constructing a surgical approach that doesn't cause concern for particular nerve damage.

[00:15:05] Speaker 01:
It's not going where sensitive nerves are present.

[00:15:08] Speaker 01:
it can be performed safely without nerve monitoring.

[00:15:11] Speaker 01:
These surgeries are constructed based in part on the tissues that they're navigating and the safest, you know, least invasive path, and Cosman is no exception to that.

[00:15:23] Speaker 01:
That's a factual finding the board made.

[00:15:25] Speaker 01:
So if Cosman can be performed without nerve monitoring safely, then it begs the question, what necessitates or what motivates

[00:15:34] Speaker 01:
employing a completely more complicated nerve monitoring system.

[00:15:39] Speaker 01:
And the answer the board provided to that was these two particular types of nerves can be monitored.

[00:15:45] Speaker 01:
That's just wrong.

[00:15:46] Speaker 01:
They can't be monitored and there's no substantial evidence to support that.

[00:15:49] Speaker 01:
And again, this is something that has not been defended and is indefensible, to be honest.

[00:15:59] Speaker 01:
I have 30 seconds remaining.

[00:16:00] Speaker 01:
There are other issues.

[00:16:02] Speaker 00:
You're briefed.

[00:16:02] Speaker 00:
We'll save you rebuttal time.

[00:16:04] Speaker 00:
Let's hear from the office.

[00:16:05] Speaker 01:
Thank you, Your Honor.

[00:16:19] Speaker 04:
Mr. Hickman.

[00:16:19] Speaker 04:
Thank you, Your Honor.

[00:16:20] Speaker 04:
It may please the court.

[00:16:26] Speaker 04:
Surgeons have long known that it's important to be careful when operating around nerves, and they have long

[00:16:32] Speaker 04:
dealt with that challenge by using nerve monitoring technology.

[00:16:35] Speaker 04:
The method claimed here employs nerve monitoring technology with electrified instruments.

[00:16:41] Speaker 04:
That's what Kelleher used for his spinal surgeries, and it's also what Kelleher says can be used essentially anywhere else in the spine when a surgeon needs to navigate around nerves.

[00:16:52] Speaker 04:
The invention in the patent at issue here is Kelleher's, it's just Kelleher applied to a specific bundle of nerves in the psoas muscle.

[00:17:00] Speaker 02:
But your friend on the other side says you conceded that Kelleher can't monitor these two specific nerves that are critical here.

[00:17:09] Speaker 02:
Is that correct?

[00:17:11] Speaker 04:
No, it's not, your honor.

[00:17:12] Speaker 04:
And I think what's going on with those two nerves is that, to sort of step back and take a look at the anatomy, is that the lumbar plexus is sort of the bundle of nerves that are at issue here.

[00:17:23] Speaker 04:
And much of that plexus runs through the psoas muscle itself.

[00:17:28] Speaker 04:
But the iliohypogastric and the ilioinguinal nerves are two nerves that run outside the muscle and could potentially cross the surgical field when a surgeon is coming in and trying to take a lateral approach into the psoas muscle.

[00:17:45] Speaker 04:
When the board addressed those two nerves on page 12 of the appendix, specifically in footnote four, what I think the board was responding to was that one of the

[00:17:58] Speaker 04:
One of the invasive experts had apparently questioned whether Kelleher's nerve monitoring technology could actually deal with those two nerves running outside the psoas muscle.

[00:18:12] Speaker 04:
And the board's rationale was it doesn't matter if it's running outside the muscle or inside the muscle, those two nerves are still part of the lumbar plexus, and those are exactly the nerves that we're dealing with here.

[00:18:24] Speaker 04:
So whether they run inside the muscle or outside,

[00:18:27] Speaker 04:
the psoas muscle, we're talking about the same plexus of nerves.

[00:18:32] Speaker 04:
And Kelleherd gives us every indication that it can navigate around nerves, whether they're inside the muscle or outside.

[00:18:39] Speaker 03:
Is it true that the board's decision that's on review now is the first time anywhere where anybody, including the board, raised the idea of using Kelleherd's nerve monitor

[00:18:57] Speaker 03:
to monitor the iliohypogastric and ilioguinal and guinal nerves?

[00:19:06] Speaker 03:
They said that the re-exam requester didn't argue that, nor did the examiner.

[00:19:13] Speaker 03:
Obviously the examiner didn't.

[00:19:14] Speaker 03:
The examiner found the claim was patentable.

[00:19:17] Speaker 03:
Nor did the board in the initial decision articulate that theory of how the nerve monitor would be used.

[00:19:24] Speaker 03:
So I'm just wondering, is it true that

[00:19:26] Speaker 03:
this board decision at A12 focusing on these two nerves is the first time that these two nerves were identified as the rationale for why you would use Kelleher's nerve monitoring?

[00:19:40] Speaker 04:
I don't think it's the first time, because I believe the board was responding to an argument that Nubase or one of its experts had actually made.

[00:19:49] Speaker 04:
And it was just a response to that argument with respect to those two specific nerves.

[00:19:55] Speaker 04:
And the board just said,

[00:19:57] Speaker 04:
even if those two nerves run outside the psoas muscle, we still think that Kelleher is capable of dealing with those two nerves.

[00:20:05] Speaker 04:
And Judge Chen, as you had pointed out during the opening portion of the argument, Kelleher is already in the field of spinal surgery and Kelleher uses the same

[00:20:19] Speaker 04:
technology that's being claimed and described here, which is to use electrical charges to stimulate nerves and when those nerves innervate or cause the associated muscles that they're associated with to flex or to contract, that feedback loop provides the surgeon with information about whether the instrument is too close to the nerve.

[00:20:48] Speaker 04:
hold Kelleher and this patent side by side, specifically at pages 10196 of the appendix, which is Kelleher's specification, and this specification in the 057 patent appendix, page 64 in column 12.

[00:21:05] Speaker 04:
And they recite essentially the same thing that's going on with the nerve monitoring technology.

[00:21:12] Speaker 03:
I guess I'm trying to figure out what to do about

[00:21:16] Speaker 03:
other side.

[00:21:16] Speaker 03:
Nubasev's argument that, well, it never had a chance to really rebut this argument that one would use Kelleher's nerve monitor to monitor these two nerves, and if it had had that chance to respond to it, it would have put on evidence that Kelleher's nerve monitor

[00:21:42] Speaker 03:
for whatever reason is incapable scientifically to monitor these two specific nerves.

[00:21:50] Speaker 03:
And so I'm not sure what to do with that.

[00:21:53] Speaker 03:
It's either something that they forfeited and waived because it was in play and that they, for whatever reason, chose not to pursue it, or it was sprung at them at the last minute in the board's decision

[00:22:09] Speaker 03:
And therefore, it seems like they didn't have an opportunity to respond to something because it was sprung on them in the last minute.

[00:22:17] Speaker 03:
Which way am I supposed to think about this?

[00:22:20] Speaker 04:
Well, Your Honor, as I explained earlier, I don't think it was sprung on them because I think the board was just responding to an argument that they themselves had made.

[00:22:29] Speaker 04:
And it was really just the same rationale that the board had applied with respect to the remainder

[00:22:37] Speaker 04:
the nerves themselves running through the psoas muscle.

[00:22:39] Speaker 04:
So that there's no difference between the nerves, whether we're talking about whether they're outside or inside the psoas muscle.

[00:22:47] Speaker 04:
But if nuvasive itself is the party that raised the argument, I'm not sure how it could have had the argument sprung upon it or had this theory sprung upon it.

[00:22:59] Speaker 04:
The board is simply responding to what nuvasive itself argues.

[00:23:02] Speaker 03:
So then you read the board's decision in saying maybe two different things.

[00:23:07] Speaker 03:
Everybody knows in spinal surgery, any spinal surgery, you need to stay away from the nerves.

[00:23:12] Speaker 03:
Touching the nerves is a no-no.

[00:23:14] Speaker 03:
And so that's why there's these prior art references that talk about using a nerve monitor with spinal surgeries.

[00:23:21] Speaker 03:
It'd be obvious likewise to use nerve monitors in a spinal surgery taking a lateral transzoas approach, thereby rendering the claim obvious.

[00:23:33] Speaker 03:
In addition, when it comes to these two specific

[00:23:37] Speaker 03:
nerves that are referenced in Cosman, you could use Kelleher's nerve monitor to track those two nerves.

[00:23:47] Speaker 03:
Is that the way to understand the board's decision, kind of two different rationales?

[00:23:53] Speaker 04:
I think they're all wrapped up in the same rationale, and with respect to those two nerves, it was really a relatively minor point.

[00:24:01] Speaker 04:
I would also point out that this patent itself doesn't actually claim anything with respect to the iliohypogastric or the ilioenguial nerves, and it doesn't specifically, as far as I know, the specification doesn't specifically name those nerves by name.

[00:24:16] Speaker 04:
I don't think the scope of this patent that we're dealing with is even narrow enough to really raise that issue significantly.

[00:24:34] Speaker 03:
What about secondary consideration evidence?

[00:24:38] Speaker 03:
This is the XLIFT guide and the question of whether the board misread the import of the XLIFT guide as being devoted to this claimed procedure.

[00:24:56] Speaker 04:
How I interpret nuvasives, what I interpret nuvasives' position to be on secondary considerations is that the board, as a matter of law, should have taken Dr. Phillips's declaration and the surgical guide as they were and not looked at any of the other evidence in the record to shed light on that surgical guide and Dr. Phillips's declaration.

[00:25:23] Speaker 00:
It does look as if the board misstated

[00:25:26] Speaker 00:
the law.

[00:25:27] Speaker 00:
I think the real question is, had the board considered all of the evidence of how this development was being received and the changes from what had come before, that it may well, as the secondary considerations traditionally do, have affected the view, the pertinence, the weight of the prior art?

[00:25:53] Speaker 00:
How does one

[00:25:55] Speaker 00:
respond to that when the board explicitly states they're not going to follow that method of analysis?

[00:26:02] Speaker 04:
Well, the board did state that it would follow that method of analysis, and there are pages in the board's decision that examine the secondary consideration evidence that New Base have offered.

[00:26:12] Speaker 02:
But isn't the problem here that they refuse to acknowledge the nexus?

[00:26:16] Speaker 02:
I mean, there's definitely evidence, as you suggested, points to

[00:26:23] Speaker 02:
There are other ways of why this secondary consideration doesn't render this not obvious, but it refused to recognize that there was a nexus between the claim method and the XLF product.

[00:26:36] Speaker 02:
That just seems to me to lack substantial evidence.

[00:26:39] Speaker 02:
I mean, don't dispute the content of that claims chart, do you?

[00:26:44] Speaker 02:
No, the claim chart says what it says.

[00:26:47] Speaker 02:
And the claims chart specifically attracts the method of

[00:26:52] Speaker 02:
claims to what's in the product sold by them under the XILF name, doesn't it?

[00:27:00] Speaker 02:
It does.

[00:27:01] Speaker 02:
This is even more specific information we usually get to show nexus.

[00:27:06] Speaker 02:
It reaches each and every element, doesn't it?

[00:27:10] Speaker 02:
So isn't that sufficient to show nexus?

[00:27:14] Speaker 02:
And then it's the board's obligation to go on and explain even if there is nexus or other competing reasons why

[00:27:21] Speaker 02:
these secondary considerations don't support a finding of non-obviousness.

[00:27:27] Speaker 04:
I would agree with you, Judge Hughes, if we still had an adversarial party below, if Globus, which was the requester in this case, if Globus had still been involved in the case and had an opportunity to rebut that claim chart and the surgical guide and chose not to or said,

[00:27:49] Speaker 04:
you know, we agree there's no issue, that that might be a different case.

[00:27:54] Speaker 02:
But what does it make a difference on whether there's a party to rebut that or not?

[00:28:00] Speaker 02:
I mean, once they've established sufficient evidence to show nexus, then nexus is presumed.

[00:28:06] Speaker 02:
And if the board can't determine, the board just has to determine based upon the record it has.

[00:28:12] Speaker 02:
And if it doesn't have evidence rebutting it, then doesn't it have to go with the

[00:28:17] Speaker 02:
the nexus of this and give them proper secondary considerations.

[00:28:21] Speaker 02:
That doesn't mean it necessarily renders it non-obvious.

[00:28:24] Speaker 02:
It could still be the evidence of obviousness on the Prima Patia case is so strong that it's not overcome.

[00:28:32] Speaker 02:
But I don't understand how the lack of somebody on the other side makes a difference in the analysis.

[00:28:41] Speaker 04:
Well, as you mentioned Judge Hughes, I think it's because the

[00:28:45] Speaker 04:
we can assume that if there's an adversarial party, then that adversarial party would be in the best position to know whether that evidence should be rebutted, whether there's something else out there that would rebut the presumption of nexus.

[00:28:59] Speaker 04:
What the board did here was that it just sort of, it looked at everything in the record, and I think the big consideration that counterbalances the claim chart and the surgical guide is that we have to look at

[00:29:14] Speaker 04:
sort of the overlapping nature of the products in this field.

[00:29:17] Speaker 04:
And we have method claims here, but we have products that involve methods, devices, systems.

[00:29:27] Speaker 04:
It's a very crowded field with different

[00:29:29] Speaker 04:
components.

[00:29:30] Speaker 02:
Sure, I get on that, but that's the problem with the board's analysis is it didn't do a proper nexus analysis, and you're trying to kind of backfill that with the suggestion, well, maybe the commercial success here is not due to the patent method claim, maybe it's due to the fact that, you know, this specific set of tools that's one subset is what drives the method, or that if you

[00:29:56] Speaker 02:
purchase this method, they'll throw in a bunch of tools for free.

[00:29:59] Speaker 02:
There are all kinds of reasons why the Nexus can be rebutted, but it doesn't cure the error in the fact that the board said no Nexus, when it seems to me clearly there was Nexus here.

[00:30:15] Speaker 04:
Well, what I believe, Your Honor, is that the board

[00:30:20] Speaker 04:
specifically address those considerations and just came to the opposite conclusion that there was no nexus because of all those reasons that I just stated.

[00:30:29] Speaker 02:
The board noted that... But that's not how a nexus analysis works, is it?

[00:30:34] Speaker 02:
I mean, the nexus is, for purposes at least of a presumption, you get it if you show the patented method is embodied by the commercial product.

[00:30:49] Speaker 02:
What you're talking about is rebutting that presumption with other evidence.

[00:30:55] Speaker 02:
They didn't do that analysis.

[00:30:58] Speaker 02:
Again, I think you're trying to ... It almost sounds like you're trying to make a harmless error analysis here, but I don't understand how there's sufficient factual findings here to do that.

[00:31:12] Speaker 04:
PPC broadband, which was in the briefing, says that when there's an adversarial party, Judge Hughes, the way you described it is how it would work.

[00:31:20] Speaker 04:
But we're in a different landscape when we're only talking about one party.

[00:31:25] Speaker 04:
And my time is up, but I would say in addition to that, even if the court finds the board's

[00:31:35] Speaker 04:
objective analysis lacking here.

[00:31:36] Speaker 04:
I think that the prima facie case based on the yard is still quite strong.

[00:31:40] Speaker 04:
And for that reason, we still ask that the court affirm.

[00:31:44] Speaker 00:
Do you want to ask anything else?

[00:31:48] Speaker 00:
Okay.

[00:31:49] Speaker 00:
Thank you.

[00:31:49] Speaker 00:
Mr. Rosado.

[00:31:57] Speaker 01:
Thank you, your honor.

[00:31:59] Speaker 01:
So on that last point, this is addressed in our briefing, blue brief at 54.

[00:32:05] Speaker 01:
But as this court will be aware, there is a presumption of nexus in inter-parties re-examination proceedings.

[00:32:13] Speaker 01:
The Classico versus Apple case is cited, and there certainly should be an instance of where there's presumption of nexus in this case.

[00:32:21] Speaker 01:
And there really shouldn't be any presumption of some sort of reluctance to consider secondary considerations or objective evidence.

[00:32:32] Speaker 01:
in some ways the most important type of evidence that can be submitted in these cases.

[00:32:36] Speaker 01:
Precisely because it's objective, it's not controlled by the lawyers or the parties per se.

[00:32:43] Speaker 01:
It's objective in the sense that nobody's controlling it.

[00:32:49] Speaker 01:
What comes with that is the fact that since nobody's controlling it and lawyers aren't scripting it, it doesn't read like a claim.

[00:32:58] Speaker 01:
There's a process of

[00:33:00] Speaker 01:
of assessing that, and that's a process the board didn't go through here.

[00:33:04] Speaker 01:
But there is a presumption of nexus.

[00:33:06] Speaker 03:
I do want to go... Can we talk about just trying to understand the guide just so I understand it?

[00:33:13] Speaker 03:
All the tools that are illustrated in the guide are used in the XLIFT procedure, which corresponds to the patented method.

[00:33:25] Speaker 03:
Is that right?

[00:33:26] Speaker 01:
Uh, I believe that's, I don't remember every single tool that's in the guide, your honor, but, um... Okay, because it says on the cover page, XLIF guide or something like that, right?

[00:33:38] Speaker 01:
It does.

[00:33:38] Speaker 01:
Yeah, I think it, it reads XLIF surgical procedure.

[00:33:42] Speaker 01:
Okay.

[00:33:42] Speaker 01:
Um, and it walks through the steps of that surgical procedure and those steps map precisely to what's recited in the claim.

[00:33:49] Speaker 03:
Okay.

[00:33:50] Speaker 03:
And the tools that are illustrated in that guide, um, does Nuvasiv sell them?

[00:33:57] Speaker 03:
all of them just for this trans-soas spinal procedure, or are some of those items also sold and used for other surgeries, aside from this lateral trans-soas pathway surgery?

[00:34:17] Speaker 01:
I think those tools are designed for XLIFE, the XLIFE surgical procedure.

[00:34:23] Speaker 01:
Again, I'm reluctant to say, I don't remember every single tool.

[00:34:26] Speaker 03:
Like the nerve monitor?

[00:34:27] Speaker 03:
whatever that thing is called by name.

[00:34:31] Speaker 03:
Is that, does nuvasives sell that to people to be used just for the lateral transoath type procedures or is that nerve monitor that nuvasive cells could be used or is used for other purposes?

[00:34:49] Speaker 01:
If there's an off-label use, I'm not sure to be honest.

[00:34:55] Speaker 03:
Is the on-label use specifically

[00:34:57] Speaker 01:
It is sold specifically for xLIF.

[00:35:00] Speaker 01:
It is a key and recognized in the marketplace as a key and critical component of the xLIF system.

[00:35:08] Speaker 03:
So all the tools, are they all basically sold together?

[00:35:11] Speaker 03:
Is that how it works?

[00:35:14] Speaker 03:
Or are some of them sort of off-the-shelf items, stand-alone packages that people can run into an evasive and just buy for whatever purpose it wants to use?

[00:35:24] Speaker 03:
Or are they all used

[00:35:26] Speaker 03:
as a package and always sold as a package, and therefore you always know that whenever you have sales of your retractor system or your dilator system or your nerve monitors, we can always know that they're always going to be used for this lateral trans-soas surgical procedure.

[00:35:43] Speaker 01:
The company is certainly able to track the sales of those components and usage with XLIF.

[00:35:50] Speaker 01:
Absolutely.

[00:35:51] Speaker 03:
Is that what the data reflects though, the actual records?

[00:35:56] Speaker 01:
the actual sales techniques?

[00:36:00] Speaker 03:
The products that Nuvasive is selling, that the products that are part of the xLiv package are only used for the xLiv package.

[00:36:12] Speaker 03:
So that whenever you have sales broken out for your retractors, your dilators, your nerve monitors, Nuvasive can stand behind those records of sales and say, all of these sales

[00:36:26] Speaker 03:
are for the lateral transsoas path surgeries that people use these products for and not for anything else.

[00:36:33] Speaker 03:
So that's why all of the commercial success is dedicated to the claimed invention, not for other procedures.

[00:36:43] Speaker 01:
Sure.

[00:36:44] Speaker 01:
The short answer is yes, that is trackable.

[00:36:47] Speaker 01:
And there's... Is trackable, but has it been tracked?

[00:36:53] Speaker 03:
It has been tracked.

[00:36:53] Speaker 03:
Is it in fact in the record?

[00:36:56] Speaker 01:
It is in the record, I think there's actually even a sales chart that was obtained through discovery with litigation with Medtronic, where Medtronic, a different company, was tracking the very sales associated with these products.

[00:37:10] Speaker 01:
So not only can Nuvasive track it, but other players in the marketplace have no trouble tracking that information.

[00:37:17] Speaker 01:
If I may, Your Honor, can I just address?

[00:37:21] Speaker 01:
Please proceed.

[00:37:21] Speaker 01:
Thank you.

[00:37:23] Speaker 01:
So back to the nerve monitoring and the basis of the board's decision, I just want to respectfully correct a couple of things.

[00:37:30] Speaker 01:
I always appreciate how the director is able to come in on these cases, but there are some factual issues that aren't quite correct in terms of the record.

[00:37:42] Speaker 01:
I would disagree that monitoring of these two nerves was a relatively minor point.

[00:37:49] Speaker 01:
I think the record is clear in the board's decision on pages A12 and A13 that this was a critical finding.

[00:37:57] Speaker 01:
And the board argued very loudly, quite frankly, that these two nerves are all that need to be monitored and no other nerves even need to be addressed.

[00:38:11] Speaker 01:
And they say that very, very explicitly in multiple locations.

[00:38:15] Speaker 01:
So this is not a minor point.

[00:38:17] Speaker 01:
This is a critical aspect of the decision.

[00:38:19] Speaker 01:
And unquestionably, this was something that did come up in the first time in the final decision, and the record is very clear on that.

[00:38:30] Speaker 01:
Nobody would have made it.

[00:38:31] Speaker 01:
Dr. Lieberman, the expert on the other side, I have a hard time believing, would have made this argument even had it been contemplated.

[00:38:39] Speaker 01:
But it wasn't made.

[00:38:40] Speaker 01:
So that point is beyond dispute.

[00:38:43] Speaker 01:
And then finally, a really critical aspect of this,

[00:38:46] Speaker 01:
I actually appreciated my friend made the qualification when he was referring to Kelleher as being useful for any surgery, the qualifier being when nerves need to be monitored.

[00:38:59] Speaker 01:
And that is the critical aspect and that ties precisely into the lack of motivation here.

[00:39:04] Speaker 01:
It cannot be said that one would just want nerve monitoring during any surgery.

[00:39:10] Speaker 01:
The key qualifier is when nerves need to be monitored and there are many surgeries

[00:39:15] Speaker 03:
and surgeries like Cosman that are specifically designed to avoid problems with the nerves based on... I guess the concern I have is you have experts and declarations, and there's also background information that all say the same thing, which is going through the psoas muscle is very dangerous.

[00:39:37] Speaker 03:
There's a lot of nerves.

[00:39:39] Speaker 03:
And so you're expert saying you wouldn't be inclined to do that because of all the nerves.

[00:39:44] Speaker 03:
And so if you're going to do a trans-soas procedure like Cosman did, it begs the question, why wouldn't you use a pre-existing known nerve monitor for other surgical pathways to the spine with a trans-soas path?

[00:40:02] Speaker 01:
Right.

[00:40:02] Speaker 01:
So again, we have the fortune of the most pertinent cases from this court that are relevant to this being in-ray nuvasive,

[00:40:11] Speaker 01:
in reinvasive, in reinvasive, but this is, I'm referring to the in reinvasive case that dealt with the motivation to combine issue, where the court emphasized that the need for specificity here pervades, right?

[00:40:25] Speaker 01:
There's a need for specificity in these types of analyses, and that is directly on point with what's going on here.

[00:40:33] Speaker 01:
Do you need nerve monitoring?

[00:40:35] Speaker 01:
And what is the SOAs, trans SOAs approach?

[00:40:39] Speaker 01:
There is extensive evidence

[00:40:41] Speaker 01:
on this issue of going through the psoas, and when you would want to use nerve monitoring when going through the psoas, that is when you're going through the nerve-rich region.

[00:40:53] Speaker 01:
There is extensive evidence that Cosman was primarily seeking to avoid the psoas by manually retracting it, and only in the events where it couldn't be completely retracted out of the way was the surgeon bluntly dissecting with his fingers the outer fibers of the muscle.

[00:41:11] Speaker 01:
And there's testimony that those outer fibers are not a nerve-rich region, and that's why nerve damage wasn't of significant concern.

[00:41:21] Speaker 01:
And the board made the finding that I referenced earlier consistent with that point.

[00:41:25] Speaker 01:
So in that surgery, in the primary reference of Cosman, which is being sought to be modified, nerve damage is not of concern, and nerve monitoring was not necessary for a safe procedure.

[00:41:37] Speaker 01:
So again, it comes back to the question,

[00:41:40] Speaker 01:
why would a person with a borderline skill be motivated to use this particular surgery in Cosman?

[00:41:46] Speaker 01:
That's this particular neuromodering approach of Kelleher.

[00:41:51] Speaker 01:
Again, there is no need for a nerve monitoring if you're thinking about the nerves through the psoas.

[00:41:55] Speaker 01:
That's why I agree with my friend here that the board pivoted in response to nuvasives argument, but they pivoted to something new, and that's these two other nerves.

[00:42:07] Speaker 01:
Once they made that pivot,

[00:42:09] Speaker 01:
they ran into technical errors on whether that would be performed in a lack of evidence.

[00:42:17] Speaker 01:
So thank you and thank you for the extra time.

[00:42:19] Speaker 00:
Thank you, Bruce.

[00:42:20] Speaker 00:
The case is taken under submission.