[00:00:02] Speaker 00:
The United States Court of Appeals for the Federal Circuit is now open and in session.

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God save the United States and this Honorable Court.

[00:00:13] Speaker 03:
Good morning, everyone.

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We have four argued cases today and one case submitted on the briefs.

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The first argument is appeal number 20-1708, Nubase versus Hirschfeld.

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Mr. Rosano, whenever you're ready.

[00:00:31] Speaker 01:
Thank you, Judge Chen, and may it please the Court.

[00:00:34] Speaker 01:
This is the second appeal in an inter-parties re-exam that's been pending nearly a decade, and the Board's current decision repeats the same errors identified in the Board's prior decision that was before this Court.

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Subject to questions, I'll address three main issues.

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The first is that what is now the Board's third decision in this case represents yet another new ground of rejection to which new base was never accorded an opportunity to respond.

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And second, just like the board's prior obviousness theory that was subject to vague tort and remand, the board's new obviousness theory is based on an unsubstantiated motivation to combine that just doesn't make anatomical sense.

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And then third and finally, despite the remand instructions from this court to consider objective indicia of non-obviousness, as we read the decision, it's apparent that the board did no such thing.

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While it acknowledged the court's instructions on remand,

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it then proceeded to repeat the exact same content of the decision that this court had vacated.

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Each of these issues represent an independent reason why the decision should not stand.

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And I'll start with the court's permission with the new ground of rejection.

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And to the extent it's helpful for the court, I want to point out that there is a bulleted chronology of the case at pages 14 through 16 of Nubase's reply brief.

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And what we see

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is that the last time New Base have had an opportunity to respond to a rejection or submit evidence in this case was in September 2014, nearly seven years ago.

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At that point, New Base have had significantly amended Claim 17 and in response, the examiner allowed the amended claims with no rejection and Globus, the original requester, abandoned participation in the contest.

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So the only rejections to ever be applied against these amended claims is where the board entered new rejections and made those decisions final.

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That happened in the board's second decision, which was previously before this court, and remanded as having a new rejection.

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And it occurred again in the current decision on the third decision.

[00:02:46] Speaker 03:
This is Judge Chen.

[00:02:47] Speaker 03:
This new ground of rejection theme

[00:02:54] Speaker 03:
Did you raise this in your blue brief?

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I don't remember this.

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I remember your argument that there is no substantial evidence of a motivation to combine and then also that the board incorrectly analyzed the secondary consideration evidence.

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I don't remember an argument saying the board was somehow did something inappropriate by returning to

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a theory of motivation to combine these two references that it had expressed in its first board decision.

[00:03:32] Speaker 01:
So, yeah, I want to address this idea of returning, but to answer your first question, Your Honor, it was certainly raised.

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I would direct attention to page four of the brief.

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The final paragraph starts to address this issue where it states that the board's third decision is also procedurally confirmed.

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The board refused to designate its rejection as a new ground.

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and it continues on there and there's additional argument including a section within the brief itself.

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Was it in your argument section?

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Yes.

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Let me find you the page.

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Thank you.

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It's in the argument section.

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It begins at page 35.

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It asks if the court does not reverse the board.

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It should at a minimum be remanded based on APA due process.

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And there's additional argument on that point.

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All right.

[00:04:43] Speaker 01:
That's the summary of the argument, right?

[00:04:46] Speaker 01:
That's the summary, sure, and page 65 continues the argument.

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Make sure I have the page right on that.

[00:04:57] Speaker 01:
Sorry, page 62.

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The board erred by denying the base of an adequate opportunity to respond to the board's rejection of the amended Claim 17 and continues on from there.

[00:05:17] Speaker 03:
So what would you say differently in a new brief to the board that you did not say to the board the first time around when the board in the first decision for Claim 19, which has now been incorporated into your amended Claim 17 for...

[00:05:46] Speaker 03:
arguing against the combination of Kauffman and Kelleher?

[00:05:53] Speaker 01:
Sure, Your Honor.

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That's an important question.

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So we would have a lot to say, because we've never had a chance to say anything about this.

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Again, we significantly amended Claim 17.

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It does not simply include the content of Claim 19.

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I know that argument is raised in the PTO's brief, but that's incorrect.

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verified by simple comparison of the two claims.

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But as I understand, the old Claim 19, it was about doing neuromonitoring for a lateral approach to spinal surgery through the psoas muscle.

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That's what basically Claim 19 covered, right?

[00:06:37] Speaker 01:
Claim 19 merely recited the generic term neuromonitoring.

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Amended Claim 17 was amended to recite EMG-based neuromodering that's directional and proximity-based and which occurs during the process of creating the distraction surgical corridor.

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So Claim 17 includes far more detail and is far narrower and significantly different in scope than Claim 19.

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So it's a completely different and new claim.

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It looks nothing like Claim 19.

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So it's very different in scope.

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And that went before the examiner.

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The examiner reviewed that claim, reviewed the art, and allowed the claims.

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So again, we never had any opportunity to respond to any rejection of this amended claim.

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Again, the only rejections that have occurred are the ones the board made in its decisions and made final in violation of its own rules, which require that if the board enters a new ground.

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Right.

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I'm just trying to understand what is it

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uh, you wanted to further argue, uh, especially in light of what this court said in its 2018 opinion, uh, where, um, it heard your arguments about why a skilled artisan would not combine Cosman and Kelleher.

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And we specifically rejected that.

[00:08:07] Speaker 01:
Well, it heard some arguments and we have to appreciate there's a very unusual procedural posture where argument was really cut off and dates back years and years ago as it pertains to a different claim and the decision to amend that claim significantly presented a claim of different scope.

[00:08:33] Speaker 03:
I'm talking about what happened in

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this court's opinion in 2018, which is about the very same claim or claims that we have in front of us now, and is also about the very two references that we have in front of us now, Cosman and Kelleher.

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Right.

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So you'll recall, Your Honor, that the reason a new ground was found in that instance is because the board in its second decision had moved beyond the

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you know, they were looking at generic claim 19 and since it just said neuromonitoring, they had moved their rationale far beyond the generic assertion that neuromonitoring was known to the specific rationale that the particular neuromonitoring of Kelleher would have been imported to monitor for these particularly identified sensory neurons, the iliohypogastric and ilioenguinal nerves.

[00:09:28] Speaker 01:
That was the issue before this court previously.

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That was not only a new theory, but one that made no anatomical sense, as Kelleher is a system that's designed to monitor for a very specific type of nerve, motor nerves that innervate the patient's legs.

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So as we explained to this court at the time, had we been- No, I'm sorry.

[00:09:48] Speaker 03:
We don't have a lot of time here.

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I'm really focused on what this court said at Pinpoint 998.

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in the Kauffman and Kelleher section where we summarize some of Nubase's arguments against the motivation to combine Kelleher's neuro-monitoring with Kauffman's surgical procedure and we identified them and we rejected them.

[00:10:28] Speaker 03:
So that's as it... There was some briefing that occurred, and there was some analysis that occurred, and then there were some rulings that occurred.

[00:10:40] Speaker 01:
And the court agreed with us on the point that this new theory of once the board moved to a specific type of nerve, and they had to based on these specific claims.

[00:10:50] Speaker 03:
Right.

[00:10:50] Speaker 03:
Take the two nerves out.

[00:10:52] Speaker 03:
Don't worry about the two nerves.

[00:10:53] Speaker 03:
That's not what we're focused on.

[00:10:55] Speaker 03:
That's not the thrust of my question.

[00:10:57] Speaker 03:
My question is that you want to argue a bunch of things and I'm trying to figure out how to deal with those arguments given that they appear to have already been asked and answered by this court in the prior opinion at this particular pinpoint.

[00:11:15] Speaker 01:
And that's where the new thrust of the board's current rejection comes in.

[00:11:18] Speaker 01:
They've replaced those other specific nerves with a new set of specific nerves that were never raised in rejection, never raised in any of the prior

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board decisions, not in the first decision.

[00:11:30] Speaker 01:
The board's now proposing the monitoring would occur specifically to detect motor neurons of the lumbar plexus.

[00:11:36] Speaker 01:
That never comes up in the first decision.

[00:11:38] Speaker 01:
It was never a rejection by the examiner.

[00:11:41] Speaker 01:
And we have a lot to say about that.

[00:11:43] Speaker 01:
We addressed this in our briefing, but the bottom line is that the board is now proposing, they're doing the same thing.

[00:11:51] Speaker 01:
They've replaced one specific set of nerves with a different specific set of nerves that were never addressed.

[00:11:56] Speaker 03:
What is that other specific set of nerves you're talking about?

[00:11:59] Speaker 01:
In the board's decision, they repeatedly raised the motor neurons of the lumbar plexus.

[00:12:11] Speaker 01:
It's identified many times in the third decision from A12 to A16 that never came up in the first decision.

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So despite the board saying we're going to return,

[00:12:22] Speaker 01:
they hit rewind and then continue to hit fast forward and come up with a completely new theory.

[00:12:27] Speaker 03:
Mr. Rosado, you're into your rebuttal, but I want to make sure you get to save some of it.

[00:12:33] Speaker 03:
If there's anything else you want to say, I'll give you another minute right now, and then we have to move on.

[00:12:40] Speaker 01:
Thank you, Your Honor.

[00:12:40] Speaker 01:
So I'll just say on that theory, and this is an important question to address that you raised, what would we say?

[00:12:46] Speaker 01:
We would point out that the new theory replaces

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the old with specific nerves and that makes no, there's no evidence to support that.

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There's no evidence that specifically identified nerves are implicated in the Cosman surgery.

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And the literature of reference indicates that those nerves are not implicated in Cosman surgery.

[00:13:07] Speaker 01:
They're located in a different portion of the psoas muscle that's not implicated by Cosman.

[00:13:11] Speaker 01:
So we would certainly have a lot to say about this and it's a reputable new rejection.

[00:13:18] Speaker 01:
And it's also hindsight.

[00:13:21] Speaker 01:
There's nothing in either reference, either Kaufman or Kelleher, about the lumbar plexus nerves.

[00:13:26] Speaker 01:
There's nothing in the declaration of Globus' expert, Dr. Lieberman, at 443-447 of the appendix about the lumbar plexus nerves.

[00:13:35] Speaker 01:
He doesn't mention them.

[00:13:37] Speaker 01:
Okay, I think we have to move on unless my colleagues have a specific question for you.

[00:13:44] Speaker 01:
Okay.

[00:13:45] Speaker 01:
And with that, I would just say, as I indicated in the opening,

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There's no indication that the objective indicia received meaningful consideration either.

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And with that, I'll hold.

[00:13:56] Speaker 01:
Let's hear from the government.

[00:14:00] Speaker 00:
Thank you, Your Honor.

[00:14:01] Speaker 00:
May it please the court?

[00:14:03] Speaker 00:
In light of this court's guidance and its 2018 opinion, substantial evidence supports the board's finding as to each of the two issues that this court remanded on.

[00:14:13] Speaker 00:
My friend, who represents an evasive, suggests that somehow the board created some sort of new ground of rejection.

[00:14:21] Speaker 00:
But what the board actually did was turn back to its original findings from the 2014 board decision as this court stated that it was permitted to do.

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And it found that a skilled artisan would have used Kelleher's nerve monitoring system and Kaufman's lateral trans-spillus procedure

[00:14:41] Speaker 00:
as it was more than a predictable use of systems to improve surgery outcomes.

[00:14:46] Speaker 00:
I'm not clear why New Basis Council is saying that there was some sort of focus on a specific nerve when it reverted back to this 2014 decision, but that is not what the board did.

[00:14:58] Speaker 00:
The board simply turned back and said, Cosman's lateral trans-polis procedure is looking to avoid nerve damage.

[00:15:08] Speaker 00:
Kelleher's nerve monitoring system

[00:15:10] Speaker 00:
provides that technique.

[00:15:12] Speaker 00:
So it's a pretty good use of the system.

[00:15:14] Speaker 00:
With respect to the second issue that this court remanded on, substantial evidence is also supported.

[00:15:24] Speaker 02:
This is your second question to look at.

[00:15:27] Speaker 02:
Again, in a 15 page 14 of the board's report.

[00:15:36] Speaker 00:
I'm sorry, Your Honor.

[00:15:36] Speaker 00:
Could you say that again, please?

[00:15:39] Speaker 02:
If you look at page 14, in the middle of the page, there is a reference to lumbar plexus nerve structures.

[00:15:49] Speaker 02:
Yes, Your Honor.

[00:15:50] Speaker 02:
And what's the significance of that for purposes of the 103 analysis?

[00:15:56] Speaker 00:
So much of the lumbar plexus runs through the psoas muscle itself.

[00:16:02] Speaker 00:
It's a big reason.

[00:16:06] Speaker 00:
conversation came up because Novasis makes this argument that there would not be a motivation to combine the references because Cosman's lateral trans-thoes procedure allegedly only works through a quote-unquote safe zone of the muscle.

[00:16:23] Speaker 00:
Right.

[00:16:23] Speaker 02:
And isn't this, in this opinion, isn't this the first time the lumbar plexus nerves show up?

[00:16:32] Speaker 00:
It's not the first time, but again, I just want to be clear.

[00:16:36] Speaker 02:
Your adversary's argument is that he hasn't had an opportunity to argue that the combination of the two references, because of the possibility of lumbar plexus nerve structures, that that gives strength to the combination.

[00:16:54] Speaker 02:
And he says, I'm sort of being bushwhacked.

[00:16:56] Speaker 02:
This is the first time I've heard about that, he's saying.

[00:17:00] Speaker 00:
I just want to be clear that the board wasn't relying on this idea that the prior references could be combined because of this lumbar plexus.

[00:17:10] Speaker 02:
How do we know that they weren't relying on it?

[00:17:15] Speaker 00:
Well, because if you look at APPX 11 through 12, the board is citing

[00:17:23] Speaker 00:
basically turning back to its first decision and giving the reason why it's combining the references.

[00:17:29] Speaker 00:
And there's that sort of block quote where it's talking about the fact that Kauffman is concerned with nerve damage in this, I'm sorry, is concerned about avoiding harming nerves during this procedure and that Kelleher

[00:17:47] Speaker 00:
basically can be used predictably to aid in that concern.

[00:17:53] Speaker 00:
It's not, the only reason that lumbar plexus discussion even comes up is because it's being responsive to this sort of false argument that the psoas muscle has some part of it that does not have nerves.

[00:18:10] Speaker 00:
And so the board made several findings, which was one,

[00:18:14] Speaker 00:
Even if the psoas muscle had some sort of safe zone, that falls within the scope of the trans psoas path, which this court also found, because the 057 doesn't limit lateral trans psoas path to go directly through some particular part of the psoas muscle.

[00:18:33] Speaker 00:
And then it also said that there are so many variations in anatomy of people that there are no guarantees that there are no nerves

[00:18:42] Speaker 00:
in this, quote unquote, safe zone, which again, is not really a thing.

[00:18:46] Speaker 00:
It's just something that Nubasive used to say, hey, there's some part of the psoas muscle that doesn't really have a lot of nerves, and that's what Kauffman is doing.

[00:18:56] Speaker 00:
And so when the board brought up this lumbar plexus statement, the board was basically trying to say, wait a minute, Kauffman is doing a lateral trans psoas procedure,

[00:19:11] Speaker 00:
we believe that there are nerves in the psoas muscle.

[00:19:14] Speaker 00:
But in addition, there is a lumbar plexus which runs through the psoas muscle itself.

[00:19:20] Speaker 00:
And there is also nerves in there.

[00:19:21] Speaker 00:
So if you're even trying to attempt to get there, there is a concern for skilled artisan to avoid nerve damage.

[00:19:28] Speaker 00:
But it's not some new thing that is relying on it.

[00:19:31] Speaker 00:
The board literally went back to the 2014 opinion and took from there, which this court

[00:19:39] Speaker 00:
said that the board was allowed to do on page 2-9, APPX 2958, which is also 722 fed APPX at 999.

[00:19:55] Speaker 00:
So in addition to the motivation to combine,

[00:19:59] Speaker 00:
In addition to the fact that the board had substantial evidence, which supports its finding of a motivation combined, substantial evidence also supports the board's finding that the objective evidence, when taken as a whole, failed to outweigh what the prior art proved.

[00:20:14] Speaker 00:
In evasive, this court found that there was a nexus between the claimed invention and the XLIF technology and products.

[00:20:26] Speaker 00:
and allowed the board to go back and consider objective evidence given that finding.

[00:20:31] Speaker 00:
And the board did just that.

[00:20:33] Speaker 00:
And even with the nexus, found that as a whole, Nubasis didn't have a strong enough, didn't have strong enough objective evidence to override the strong prima facie case.

[00:20:46] Speaker 00:
With respect to the commercial success, they didn't provide evidence that that commercial success was directly tied

[00:20:53] Speaker 00:
to the XLIS surgical techniques and products.

[00:20:57] Speaker 00:
The success was due to auxiliary products.

[00:21:00] Speaker 00:
In addition, they did provide market share evidence that was directly tied to the specific XLIS market share.

[00:21:10] Speaker 00:
And with respect to long-sale and unmet need,

[00:21:15] Speaker 00:
the board found that because Kauffman itself and Globus' expert Dr. Lieberman was able to show that skilled artisans were taking the trans-OS approach before the 057 patent, that there was no unsatisfied, long-felt unmet need.

[00:21:35] Speaker 00:
And with respect to skepticism and praise, the board considered all of that evidence as well and found that it did not weigh against the strong prima facie case.

[00:21:45] Speaker 00:
So unless this court has any additional questions for me, we would ask that they affirm the board's decision.

[00:21:55] Speaker 00:
And that's my time.

[00:22:03] Speaker 03:
OK.

[00:22:04] Speaker 03:
Thank you, Ms.

[00:22:05] Speaker 03:
Lateef.

[00:22:07] Speaker 03:
We'll restore Mr. Rosado's five minutes of rebuttal.

[00:22:12] Speaker 01:
Thank you, Your Honor.

[00:22:15] Speaker 01:
I'd like to again point out that the lumbar plexus nerves are mentioned at least a half a dozen times in the board's decision, a 12, a 13, 14, 15, 16.

[00:22:28] Speaker 01:
You see this repeatedly.

[00:22:29] Speaker 01:
It's central to the board's theory in the new rejection and the latest decision.

[00:22:35] Speaker 01:
The lumbar plexus is not discussed at all.

[00:22:38] Speaker 01:
in the first decision.

[00:22:40] Speaker 01:
It's unquestionably new and it's critical to the theory here.

[00:22:46] Speaker 01:
The board needed the specificity and the rationale and this is the one that they advanced.

[00:22:52] Speaker 01:
There are problems with that rationale in that.

[00:22:55] Speaker 03:
So I understand.

[00:22:56] Speaker 03:
What do you think could have been different nerves that the board was referring to in its initial board decision?

[00:23:04] Speaker 01:
Well, I don't think it was referring to any nerves.

[00:23:06] Speaker 01:
It was looking at a dependent claim that simply recited the term neuromonitoring generically.

[00:23:11] Speaker 01:
And what the board said in the first decision is it looks like monitoring for nerves was known in the art.

[00:23:17] Speaker 01:
Your claims generic, you know, were good here.

[00:23:21] Speaker 01:
Nubase have made the decision to amend their end claim 17 didn't recite neuromonitoring at all.

[00:23:28] Speaker 03:
So I'm just trying to understand because

[00:23:31] Speaker 03:
It was already well known that the lumbar plexus with all of its nerves is located in the psoas muscle and that those nerves shouldn't be come into contact with, right?

[00:23:48] Speaker 03:
Why wouldn't you therefore want to make sure if you're going to do some kind of surgical technique through the psoas muscle, avoid the lumbar plexus?

[00:24:00] Speaker 01:
Right, so you're citing the board's argument that the lumbar plexus was known, but they don't go into any more, this is an instance where a little bit of knowledge is dangerous.

[00:24:10] Speaker 01:
They don't go into what precisely was known.

[00:24:12] Speaker 01:
And what we know from Graves Anatomy, and it's in the record here at A2572, is that the lumbar plexus is in the posterior part of the psoas.

[00:24:23] Speaker 01:
I'm quoting from Graves Anatomy.

[00:24:25] Speaker 01:
There's additional evidence in the reply brief at pages five through six.

[00:24:30] Speaker 01:
So what is known is that the lumbar plexus is not in a region that's implicated in cosmin.

[00:24:36] Speaker 01:
This is something the board never seems to appreciate.

[00:24:39] Speaker 01:
They also don't seem to appreciate how Kelleher works.

[00:24:43] Speaker 01:
It's monitoring for a particular type of nerve.

[00:24:46] Speaker 01:
The examiner appreciated this, went through the references, and made findings that she wasn't seeing a rationale for this.

[00:24:54] Speaker 01:
That you've got a reference that's not, neither of the references say anything about

[00:24:59] Speaker 01:
the lumbar plexus or nerves.

[00:25:02] Speaker 03:
Didn't your expert, Philip, say something about how that the nerves, the lumbar plexus are complex and unpredictable maze within the psoas muscle?

[00:25:16] Speaker 03:
And then some other work by another doctor who points out there's a large degree of variation of the location of the lumbar plexus in the psoas?

[00:25:28] Speaker 01:
I would say the board mischaracterizes that testimony with the experts said is the references all tell us, including Gray's Anatomy, that we know where the lumbar plexus is located as far as it being in the posterior.

[00:25:41] Speaker 01:
Now, within the posterior portion, there's variability between patients, but that's neither surprising nor does it solve the board's problem here.

[00:25:51] Speaker 01:
Costman is not in the posterior portion.

[00:25:54] Speaker 01:
So the board misappropriates or misunderstands that.

[00:25:58] Speaker 01:
I mean, it'd be akin to saying, you know, patients have variability in the morphology of their ears, so you'd expect them to have an ear on their arm.

[00:26:08] Speaker 01:
Well, we know that's not true.

[00:26:11] Speaker 03:
Could you point to something that, just so before you go, is there something you can point to in the record where Phillips or someone else says, here's the section that has no nerves, you don't have to worry about this section of the psoas muscle?

[00:26:28] Speaker 01:
Again, Grey's Anatomy, Your Honor.

[00:26:30] Speaker 01:
First line of the section, Lumbar Plexus, states the Lumbar Plexus is in the posterior part of the psoas.

[00:26:38] Speaker 01:
There's a number of other references of record that are outlined in the require brief at pages five through six.

[00:26:44] Speaker 01:
I think there's two other literature references that say this.

[00:26:49] Speaker 01:
And there's fact findings from the board's second decision.

[00:26:54] Speaker 01:
Oddly, which they've stripped out of this, but I would point to a

[00:26:57] Speaker 01:
2923, where the board is characterizing Cosman.

[00:27:02] Speaker 01:
And it says, Cosman teaches a lateral approach known to be capable of performed safely through the safe zone, even without neuromodering.

[00:27:11] Speaker 01:
So even the board previously was looking at Cosman and saying, at most, this goes through the area where there aren't any nerves.

[00:27:19] Speaker 01:
They've dropped that out, pulled in this new rationale, and never give us an opportunity to respond.

[00:27:26] Speaker 01:
Finish one.

[00:27:28] Speaker 01:
Okay, you can say, go ahead and give me another sentence.

[00:27:31] Speaker 01:
Thanks.

[00:27:32] Speaker 01:
Thank you, your honor.

[00:27:33] Speaker 01:
I just want to say a comparison on secondary indicia of the current decision with the prior decision will show there's a literal cut and paste job.

[00:27:43] Speaker 01:
Content is literally cut and pasted.

[00:27:45] Speaker 01:
There's no indication there is independent analysis.

[00:27:48] Speaker 01:
Thank you.

[00:27:50] Speaker 01:
Okay, thank you.

[00:27:51] Speaker 01:
The case is submitted.