[00:00:00] Speaker 03:
The first case to be argued is Exxonix versus Medtronic, 2022, 1451, and 1452, Mr. Nelson.

[00:00:17] Speaker 03:
And for purposes of facilitating

[00:00:23] Speaker 03:
questioning and avoiding stepping on each other.

[00:00:29] Speaker 03:
Judge Toronto is invited to lead off with any questions he has, which doesn't preclude him from asking later questions.

[00:00:42] Speaker 03:
Mr. Nelson.

[00:00:44] Speaker 02:
Thank you.

[00:00:44] Speaker 02:
Good morning, and may it please the court.

[00:00:47] Speaker 02:
The challenged patents here claim a medical lead with

[00:00:51] Speaker 01:
Actually, I do need to start with an initial question.

[00:00:55] Speaker 01:
Can you speak more loudly, please?

[00:00:57] Speaker 02:
Absolutely.

[00:00:58] Speaker 02:
I will do my best.

[00:01:00] Speaker 02:
The challenged patents here claim a medical lead with electrodes at the tip for neurostimulation and rows of tines for fixation in human tissues

[00:01:11] Speaker 02:
human tissue behind them.

[00:01:12] Speaker 02:
The issue on appeal is that the board aired when it found that Axonics had failed to demonstrate why a skilled artisan would be motivated to modify the primary reference called Young, which featured one electrode at the tip of the lead and multiple rows of tines behind it to place one additional electrode at the tip of the lead with multiple rows of tines behind it as taught by Gerber

[00:01:38] Speaker 02:
and therefore reach what's taught in the recited in the challenged claims.

[00:01:42] Speaker 02:
I want to emphasize the narrow gap between Young and the challenged claims.

[00:01:48] Speaker 02:
Young already disclosed one electrode at the tip in front of all the tines.

[00:01:53] Speaker 02:
Axonics only needed to show why a skilled artisan would be motivated to get to two electrodes in front of all the tines.

[00:02:01] Speaker 02:
And the board... Yes?

[00:02:03] Speaker 03:
The board had all of this.

[00:02:04] Speaker 03:
and evaluated it.

[00:02:06] Speaker 03:
And we owe deference to the board.

[00:02:08] Speaker 03:
I haven't heard you make any reference to deference.

[00:02:15] Speaker 02:
So the board erred both as a matter of law in reaching the conclusion that there was no motivation to combine, and there is a failure of substantial evidence.

[00:02:23] Speaker 02:
And I'll explain why in a nutshell.

[00:02:25] Speaker 02:
The incoherent result the board reached was that its person of skill in the art, which it defined as a specialist in the field of sacral neuromodulation, neurostimulation of the sacral nerve, would not have followed an expressed suggestion in the young reference

[00:02:44] Speaker 02:
to combine because it would have resulted in a lead that was not suitable or not feasible, in the board's words, for use to stimulate a different nerve, the trigeminal nerve.

[00:02:57] Speaker 02:
That requirement of trigeminal stimulation is not found in the challenged claims, and it is a fact that would be of no consequence or concern whatsoever.

[00:03:08] Speaker 02:
for the board skilled artisan in sacral neuromodulation.

[00:03:11] Speaker 04:
But I thought your first point was that the patent is broader than sacral nerves and that the board made a mistake in limiting its inquiry to the sacral nerve area since the claims are broader than that.

[00:03:32] Speaker 04:
and that in defining someone skilled in the art, they adopted too narrow a focus and that this had consequences in the later analysis.

[00:03:46] Speaker 02:
Your Honor, that's correct.

[00:03:49] Speaker 02:
We believe that the board did adopt an unduly narrow definition both of the relevant art and the problem solved by the invention.

[00:03:56] Speaker 02:
I was responding to Judge Lurie's question of what's the problem here and I'm pointing to

[00:04:00] Speaker 02:
an incoherent result by the board, which is that its own personal skill in the art, who cares only about sacral neuromodulation, would have rejected this suggestion to combine, because it results in something that's not operable for trigeminal stimulation, a different nerve.

[00:04:17] Speaker 02:
So that is what I meant by that.

[00:04:21] Speaker ?:
This is Judge Toronto.

[00:04:25] Speaker 01:
Can I just ask this question?

[00:04:27] Speaker 01:
It seems to me that

[00:04:29] Speaker 01:
You're quite right to emphasize, at least this morning, the board's adoption of Medtronic's own definition of the relevant artisan, which is a sacral nerve stimulation artisan.

[00:04:45] Speaker 01:
And so the board needed to ask the question, how would that person, reading Young, understand

[00:04:55] Speaker 01:
an observation in Young about putting an electrode near the tip.

[00:04:59] Speaker 01:
And more generally, think about combining Young with Gerber to solve at least a sacral nerve problem, but in fact, even more generally.

[00:05:15] Speaker 01:
And that it is hard to understand

[00:05:26] Speaker 01:
lateral nerve problem, how it is that the analysis of young could be limited to what would work in the trigeminal nerve area where there are space limitations that I think nobody is suggesting exist outside that.

[00:05:45] Speaker 01:
If I've understood your argument, is this a legal error and if so, what is it a

[00:05:54] Speaker 01:
a simple unreasonableness criticism for purposes of substantial evidence review or what?

[00:06:03] Speaker 02:
Your Honor, it is both a failure of substantial evidence for the reasons that you just rehearsed.

[00:06:09] Speaker 02:
There is no substantial evidence to support that result that I just explained, that a person of skill in the art in trigen and sacral neuromodulation or the broader person of skill in the art in medical lead implantation

[00:06:23] Speaker 02:
that Exxonix advanced would reject Young's suggestion to add an electrode at the tip of the lead because it wouldn't be operable for trigeminal stimulation.

[00:06:33] Speaker 02:
Neither of those persons of ordinary skill in the art would have rejected that suggestion.

[00:06:37] Speaker 02:
So there is a failure of substantial evidence.

[00:06:40] Speaker 02:
But the root of that failure of substantial evidence is rooted in a legal error.

[00:06:47] Speaker 02:
The board's decision here is contrary to this court's line of cases.

[00:06:51] Speaker 02:
beginning with ally directing, holding that obviousness does not require a showing that a secondary reference like Gerber could be bodily incorporated into the primary reference Young to make an operable device.

[00:07:06] Speaker 02:
That's the wrong question under this court's authority.

[00:07:09] Speaker 02:
Instead, the question for the board is the allied erected standard, which is whether a skilled artisan would have been motivated to combine the teachings of the prior art to achieve the claimed invention.

[00:07:24] Speaker 02:
And under that standard, the fact that a proposed combination would not be operable

[00:07:31] Speaker 02:
for some purpose not recited in the claims, does not demonstrate the absence of a motivation to combine, even if that original purpose was important to the primary reference, as long as there is motivation to achieve the claimed invention, which, as we've noted, has nothing to do or is not limited to trigeminal stimulation.

[00:07:53] Speaker 02:
This court in Inrei Urbansky relied explicitly

[00:07:57] Speaker 02:
on the fact that the challenge claims did not recite the purpose or benefit that would be lost by the proposed combination in rejecting the very argument that Medtronic made here and the board adopted here.

[00:08:11] Speaker 02:
And that's at page 1244 of Urbansky.

[00:08:16] Speaker 02:
Now, Medtronic has said that, well, in Urbansky, which you wrote, Judge Lurie, that the board properly weighed the evidence and found that the combination

[00:08:25] Speaker 02:
would not render the modified process inoperable for its intended purpose.

[00:08:30] Speaker 02:
That's not what this court found.

[00:08:32] Speaker 02:
Medtronic misreads what that opinion says at page 1243.

[00:08:36] Speaker 02:
This court agreed that the proposed combination in Urbanski would render the modified process inoperable for the original purpose, but still found a motivation to combine.

[00:08:48] Speaker 02:
It did so because it found that one of ordinary skill

[00:08:52] Speaker 02:
would have been motivated to pursue the desirable properties taught by the combination, even at the expense of foregoing the benefit taught by the primary reference, in this case, trigeminal stimulation.

[00:09:06] Speaker 02:
That's what should have happened here.

[00:09:08] Speaker 02:
The cases tell us that what matters is whether a skilled artisan would be motivated to achieve the claimed invention, not some unclaimed purpose.

[00:09:18] Speaker 02:
If that teaching or suggestion would have motivated that skilled artisan to achieve the claimed invention, it's not relevant that some unclaimed purpose might be frustrated on the way there.

[00:09:30] Speaker 02:
And that's the only principle that makes sense here.

[00:09:33] Speaker 02:
It's the only principle that follows KSR's teaching that a person of ordinary skill in the art is a person of ordinary creativity too, not an automaton.

[00:09:42] Speaker 02:
The board's person of skill in the art lacks that ordinary creativity.

[00:09:46] Speaker 02:
She simply gives up, because Young's lead wouldn't be operable for trigeminal stimulation.

[00:09:52] Speaker 02:
That's not what KSR teaches.

[00:09:54] Speaker 02:
It's not what allied erecting teaches.

[00:09:56] Speaker 02:
It's not what Urbansky teaches.

[00:09:59] Speaker 02:
And it's the only principle, the principle of allied erecting, that doesn't lead to the nonsensical result that the board-skilled artisan sacral neuromodulation finds no motivation to combine, because the lead that results would be infeasible for trigeminal stimulation

[00:10:16] Speaker 02:
something over which she has no concern.

[00:10:19] Speaker 02:
Now, the board rejected this argument, claiming that an unclaimed purpose is pertinent to Motivation of the Divine.

[00:10:26] Speaker 02:
It relied on this court's decisions in Intelligent Biosys, in Ray Gordon, and Trivascular v. Samuels.

[00:10:34] Speaker 02:
As Axonics explained in its brief, none of those cases stand for the proposition that a failure of continued operability for some unclaimed purpose

[00:10:44] Speaker 02:
can overcome an unmistakable motivation to combine to achieve the claimed invention.

[00:10:50] Speaker 02:
Rather, each of those cases concerned a straightforward failure to demonstrate any motivation to combine references at all.

[00:10:58] Speaker 02:
So, for example, in Intelligent Biosys, the proposed motivation to combine was the primary reference's disclosure of a quantitative de-blocking requirement, something that was not in the claims of the challenged patent.

[00:11:14] Speaker 02:
But the second reference that was proposed as the combination, it was found, contained nothing that could accomplish quantitative Ziblocking.

[00:11:22] Speaker 02:
So of course that unclaimed purpose was relevant to motivation to combine, but only because it highlighted a failure of proof.

[00:11:31] Speaker 02:
There's nothing like that here, where Young itself expressly suggests the motivation and the combination that would achieve the claimed invention.

[00:11:41] Speaker 02:
multiple electrodes in front of rows of times.

[00:11:45] Speaker 02:
The same is true of Henry Gordon and Trivascular for the reasons we've described in our brief.

[00:11:49] Speaker 02:
So under the correct principle of law, which is whether a person of skill in the art would have been motivated to achieve the claimed invention, Young's expressed suggestion to add electrodes near the tip of the lead would have led that person of skill in the art

[00:12:08] Speaker 02:
to Gerber's complementary disclosure of multiple electrons for sacral neuromodulation.

[00:12:14] Speaker 03:
Counsel, you're into the rebuttal time you wanted to save.

[00:12:17] Speaker 03:
You can continue or save it as you wish.

[00:12:21] Speaker 02:
I will reserve my rebuttal time.

[00:12:22] Speaker 02:
I will just say that on this basis alone, leaving perhaps for rebuttal the second basis, the board's finding of no motivation to combine should be reversed and remanded.

[00:12:32] Speaker 02:
Thank you.

[00:12:36] Speaker 00:
Mr. Van Seld.

[00:12:38] Speaker 00:
Good morning, Your Honors.

[00:12:39] Speaker 00:
May it please the court?

[00:12:41] Speaker 04:
I want to... So there's at least a clear error here by the board in saying the field of the invention is limited to sacral stimulation when the claims are not so limited, right?

[00:12:53] Speaker 04:
I mean, that's clear error.

[00:12:54] Speaker 00:
No?

[00:12:55] Speaker 00:
Your Honor, I do not believe that it is error.

[00:12:59] Speaker 00:
Why not?

[00:13:00] Speaker 00:
Well, because when you look at the description of the patent,

[00:13:06] Speaker 00:
It's all about sacred newer stimulation.

[00:13:08] Speaker 00:
But... No, no, no.

[00:13:09] Speaker 04:
The claims are broader than that, right?

[00:13:12] Speaker 04:
Yes, Your Honor.

[00:13:13] Speaker 04:
The... The claims are broader than that.

[00:13:15] Speaker 04:
How can it be that the field of the invention is narrower than the claims?

[00:13:20] Speaker 00:
Your Honor...

[00:13:21] Speaker 00:
I do not believe that the board's finding of the field of invention is actually relevant to the primary dispute here or the main issue here.

[00:13:30] Speaker 04:
But that's a different question.

[00:13:32] Speaker 04:
What I'm asking you is how can it possibly be that the field of the invention is narrower than the claims?

[00:13:39] Speaker 00:
Your Honor, the board looked at the field of the invention in the context of determining who a person of ordinary skill in the art would be.

[00:13:48] Speaker 00:
So in that particular context for determining who a person of ordinary skill would be, the board is not limited to what is recited in the claims.

[00:13:59] Speaker 00:
Because the claims may vary well.

[00:14:01] Speaker 04:
Do you have a field of the invention that's narrower than the claims?

[00:14:05] Speaker 00:
Yes, Your Honor.

[00:14:07] Speaker 00:
On the express wording of the claims, the field of the invention can be narrow.

[00:14:12] Speaker 00:
Your Honor, I do not have a case to give you on

[00:14:15] Speaker 00:
how do you define the field of the invention.

[00:14:18] Speaker 04:
But I want to bring the court back to.

[00:14:21] Speaker 04:
It seems to me that the result of that is that they were somewhat dismissive of this Young reference, which isn't within the field of the invention as they defined it.

[00:14:35] Speaker 04:
That's part of the problem here.

[00:14:37] Speaker 00:
Your Honor, I think Exxonix wants you to believe that.

[00:14:41] Speaker 00:
dismissive based on the field of invention, but that is not true.

[00:14:45] Speaker 00:
If you look at the board's decision, the board credits the testimony of their declarant regarding Young disclosing several limitations of the claims.

[00:14:57] Speaker 00:
If the board were simply ignoring Young based on Young not being within the field of the invention, this appeal would have been even more simpler because the board would have simply found, look, we're not going to consider Young at all.

[00:15:10] Speaker 00:
But the board did consider Young.

[00:15:12] Speaker 04:
Here, Your Honor, the dispute... They didn't consider Young when they were looking at the Toquet line of cases where two references are in the same field of art, and that in itself suggests a combination.

[00:15:30] Speaker 04:
They did dismiss it in that connection.

[00:15:33] Speaker 00:
They did dismiss it in finding that Young does not solve the same

[00:15:40] Speaker 00:
problem as the 314 and 756 patterns.

[00:15:45] Speaker 00:
So if you were to focus on this idea that there is motivation to combine simply because the references solve the same problem as the invention, then the board there made a factual finding saying, no, look, Young does not solve the same problem as the 314 and 756 patterns.

[00:16:08] Speaker 00:
So there, I do not see how the field of the invention necessarily discredits what the board did.

[00:16:15] Speaker 00:
And I think it's important, Your Honor, to focus on what the board found as far as motivation to combine, as opposed to things that Exonix believes the board found.

[00:16:27] Speaker 00:
So there is one factual finding here by the board that is supported by substantial evidence that is dispositive.

[00:16:36] Speaker 00:
And that is the board's finding that Young's sentence about multiple active stimulation sites near the tip is not suggesting including a plurality of electrodes distal to the tines.

[00:16:51] Speaker 00:
And why is that important?

[00:16:53] Speaker 00:
That is important because the sole rationale, the sole rationale that exonics offer

[00:17:01] Speaker 00:
to modify Young to include tines distal, sorry, to include electrodes distal to the tines was based on the interpretation of that one sentence in Young.

[00:17:12] Speaker 00:
Exonix, are you?

[00:17:14] Speaker 01:
This is Judge Taranto.

[00:17:14] Speaker 01:
Can I interrupt?

[00:17:15] Speaker 01:
And also, if you could, I have a terrible time hearing you.

[00:17:20] Speaker 01:
The microphone at the lectern there is nothing like the microphone for the two judges you're talking to.

[00:17:26] Speaker 01:
And I'm struggling to hear.

[00:17:29] Speaker 01:
a good deal of what you have to say and I apologize for that, I don't know what the problem is, but on the merits, so there were two things discussed by the board, one has to do with this same problem or not same problem and putting aside, just for purposes of this question, I'll accept that the board did in fact treat Young as prior art, that was part of the consideration, it didn't

[00:17:56] Speaker 01:
the field, but then the question is how it treated it.

[00:18:01] Speaker 01:
And then the second issue was about how to interpret this near-the-tip sentence in Young.

[00:18:10] Speaker 01:
My problem with the second point is that on page 35 of the appendix where the board is discussing

[00:18:17] Speaker 01:
It adopts by reference back to the block quote on, I think, page appendix 33 of Dr. Slavin.

[00:18:26] Speaker 01:
Dr. Slavin says a skilled artisan would not interpret that, I mean, putting at least two electrodes distal to the tines, because it wouldn't work in the trigeminal area.

[00:18:40] Speaker 01:
So that, in turn, relies on the very same narrowing of focus

[00:18:46] Speaker 01:
to what would work in the trigeminal nerve area, which seems to come back to the same problem of the board's narrowing of its focus in what Young could support by way of combination, either for general nerve stimulation or even more narrowly to the skilled artisan that you proposed and the board adopted

[00:19:16] Speaker 01:
namely a sacral nerve stimulation.

[00:19:18] Speaker 01:
I don't see that as being independent of the question of whether the board mistakenly narrowed its focus to what would work for the trigeminal nerve area.

[00:19:29] Speaker 00:
So, Your Honor, let me unpack that a little bit.

[00:19:33] Speaker 00:
I think we have to go back to what was the dispute between the parties, and what is it that the board resolved.

[00:19:42] Speaker 00:
So if you look at the petition,

[00:19:44] Speaker 00:
Appendix 207.

[00:19:47] Speaker 00:
And if you look at Exonix's reply, the petitioner reply, their motivation to combine was premised on Young suggesting adding distal electrodes or adding electrodes distal to the tines.

[00:20:05] Speaker 00:
So they provided, Exonix provided one interpretation of Young.

[00:20:10] Speaker 00:
And I think you can see that on Appendix

[00:20:13] Speaker 00:
4421, which is the testimony of Exonix's declarant.

[00:20:19] Speaker 00:
He said, at least to me, the natural thing would be to add the electrode where the current electrode in Young is, which is distilled to the times.

[00:20:29] Speaker 00:
And the board cites that.

[00:20:31] Speaker 00:
So this is Exonix saying, to us, Young's sentence means x. Dr. Slavin,

[00:20:38] Speaker 00:
in his response said, well, Young's sentence doesn't mean x. And the board ultimately agreed, finding on Appendix Page 35, that Young discloses multiple active sites near the tip, not at the tip or distal to the times.

[00:20:59] Speaker 00:
In view of Young simply disclosing multiple active sites near the tip without any relation to the times

[00:21:07] Speaker 00:
and Dr. Slavin's testimony, then the board can say that, look, Exonix's rationale or its interpretation of Young is not correct.

[00:21:17] Speaker 00:
And that is a factual finding entitled to deference and appeal under the Substantial Evidence Review Standard.

[00:21:23] Speaker 01:
So again, that is not, I'm sorry, but it's not independent of the reasoning that Dr. Slavin gave, which if I remember right, and I think this is the block quote on A33,

[00:21:35] Speaker 01:
relies on what somebody reading Young and thinking about the specific trigeminal nerve space would take away, not what somebody thinking about either the more general problem of securing a nerve stimulator or the more specific problem of

[00:22:01] Speaker 01:
securing a nerve stimulator for the sacral nerve, which I just don't see how that's independent of an error, if it is an error, in the narrow focus on the trigeminal nerve area.

[00:22:21] Speaker 00:
Your Honor, the narrow focus on the trigeminal nerve area

[00:22:25] Speaker 00:
is completely appropriate here because we are trying to understand what does young mean when it says multiple active stimulation sites near the tip.

[00:22:38] Speaker 01:
That sentence... Aren't we trying to understand what the relevant artisan, and this is your artisan, the sacral nerve artisan, would take as suggested by what he's reading?

[00:22:55] Speaker 00:
Your honor, I think that's partly true.

[00:23:01] Speaker 00:
But I think the way the dispute was framed before the board is, Exxonix said

[00:23:06] Speaker 00:
this sentence means X. And the board said, no, it doesn't mean X in the context of young.

[00:23:13] Speaker 00:
And because it doesn't mean X in the context of young, the sole rationale that Exonix provided to the board for motivation to combine fails because Exonix misinterpreted the reference.

[00:23:26] Speaker 00:
This is not a situation where

[00:23:30] Speaker 00:
The argument was, look, Young suggests all these other benefits that a person of ordinary skill in the art could undertake and then ignore its teachings.

[00:23:43] Speaker 00:
There was an argument made below, the sole reasoning provided by Exonix, that Young's sentence about multiple active stimulation sites near the tip means providing

[00:23:59] Speaker 00:
electrodes distilled to the tines, and the board made a factual finding.

[00:24:03] Speaker 00:
I don't think there's anybody who would disagree.

[00:24:05] Speaker 00:
That's a factual finding by the board.

[00:24:08] Speaker 04:
that that's not what uh... young needs and in order for the board to make the factual finding the board has to understand that i wouldn't someone skilled in the art of sacral stimulation and look at that reference and say well uh... there's a problem here uh... with a facial nerve in having it near the tip because there's not enough room for it but there's no problem putting it near the tip

[00:24:36] Speaker 04:
when we're dealing with sacral stimulation?

[00:24:39] Speaker 00:
Your Honor, that's a good question, and I think hopefully this will help me also answer Judge Taranto's question.

[00:24:48] Speaker 00:
And I think it's the last part of your question, the assumption that a person of ordinary skill in the art looking at young would understand that while something may not work in young,

[00:25:03] Speaker 00:
but that would work in the sacral nerve area.

[00:25:07] Speaker 00:
There is no evidence that a person of ordinary skill in the art, at the time of the invention, would understand that if you were to use Young's lead modified the way exonics is modifying, that such a lead would not hurt a patient or would actually work in the sacral space.

[00:25:25] Speaker 04:
So without that evidence,

[00:25:29] Speaker 04:
two electrodes distal from the attachment point, right?

[00:25:34] Speaker 04:
And they rely on that.

[00:25:35] Speaker 00:
Yes.

[00:25:36] Speaker 00:
But what Gerber doesn't have, Your Honor, are tines.

[00:25:39] Speaker 04:
So this case... But if you look at Gerber, you see two electrodes distal from the attachment point.

[00:25:47] Speaker 04:
Why wouldn't you combine that with Young, which shows tines?

[00:25:55] Speaker 00:
Your Honor, I think we have to go back to the record.

[00:25:59] Speaker 00:
In the record, the argument that was presented to the board is that the motivation to combine comes from the sentence in Young.

[00:26:09] Speaker 00:
And I want to read that to you, Your Honor, from the reply.

[00:26:13] Speaker 00:
I'm on appendix page 964.

[00:26:14] Speaker 00:
I think we should look at this together, Your Honor.

[00:26:18] Speaker 00:
Exonix says on appendix page 964, Young provides the motivation to combine multiple electrodes from Gerber when it says its lead could be improved

[00:26:29] Speaker 00:
to provide multiple active stimulation sites near the tip.

[00:26:33] Speaker 00:
And then Exonix on appendix page 965 says, the tip reference here is the distal tip, where Young's original electrode was located, which is distal to all the tines in Young.

[00:26:43] Speaker 00:
So they're saying, look, the sentence is suggesting adding more distal to the tines.

[00:26:49] Speaker 00:
And the board said, no, that's not what it is suggesting.

[00:26:52] Speaker 00:
So that is a factual finding based on the record, the way that the record developed.

[00:26:57] Speaker 00:
And I understand your concern about, well, why can't we look at this more broadly?

[00:27:04] Speaker 00:
That Young is saying you can add more electrodes, and then Gerber shows multiple electrodes, and we can combine all of this.

[00:27:13] Speaker 04:
I think... You agree that Gerber shows multiple electrodes distal from the attachment point, right?

[00:27:19] Speaker 00:
I do agree with you that there is an anchoring mechanism.

[00:27:23] Speaker 00:
that is proximal to the two electrodes in Gerber.

[00:27:28] Speaker 00:
But I think what we're looking at, Your Honor, is the record and the reasoning that was offered to the board, which the board rejected.

[00:27:35] Speaker 00:
That is a factual finding that is independent of any legal error.

[00:27:39] Speaker 00:
And then coming on this whole inoperability issue, Your Honor, if a reference, if a primary reference is rendered inoperable for its intended purpose,

[00:27:51] Speaker 00:
That is a relevant factor that the fact finder here at the board can look to to find no motivation to come by.

[00:28:01] Speaker 00:
The Trivascular case says that.

[00:28:02] Speaker 00:
The Andre Gordon case says that.

[00:28:04] Speaker 04:
If there's a common purpose, and I assume you're familiar with the Medtronic case that came out yesterday.

[00:28:12] Speaker 00:
I did see that case, Your Honor.

[00:28:13] Speaker 00:
And there, in that case, there was a sentence where

[00:28:18] Speaker 00:
This court said that the inoperability aspect is not legally irrelevant to obviousness, which, again, is the same thing as saying a fact finder can consider inoperability.

[00:28:32] Speaker 00:
But again, I want to make sure that we're not hung up on inoperability in saying, OK, look,

[00:28:39] Speaker 00:
There is no motivation to combine because Young would be rendered inoperable.

[00:28:44] Speaker 00:
That's a secondary finding by the board.

[00:28:47] Speaker 00:
The primary dispositive finding by the board is that Young doesn't say what Exxonix believes it says.

[00:28:56] Speaker 00:
And that is a factual finding by the board entitled to substantial evidence.

[00:29:01] Speaker 00:
Sorry, entitled to deference under the substantial evidence standard.

[00:29:05] Speaker 03:
Thank you, counsel.

[00:29:05] Speaker 03:
As you see, your time has expired.

[00:29:08] Speaker 03:
Thank you.

[00:29:09] Speaker 03:
Mr. Nelson has some rebuttal time.

[00:29:19] Speaker 02:
Thank you, Your Honors.

[00:29:20] Speaker 02:
I first want to address what I believe is a mischaracterization of the actual argument for motivation to combine advanced viaxonics before the board.

[00:29:31] Speaker 02:
In fact, if you were to look at appendix 207 or appendix 290 in either of the two petitions,

[00:29:39] Speaker 02:
Axonics specifically advanced the theory of motivation to combine that Judge Dyke noted, which is that Young's expressed disclosure of adding an additional electrode at the tip would have led them to Gerber's disclosure of multiple electrodes at the distal end of the anchoring mechanism.

[00:30:01] Speaker 02:
That's exactly what Axonics proposed to the board and the board rejected.

[00:30:05] Speaker 02:
With respect to the notion that axonics did not show, and the board found as a separate and independent basis, that there was no motivation to add the electrode distal to all of those tines.

[00:30:21] Speaker 02:
As Judge Toronto said, it is exactly the case that the board's rejection of that motivation to combine is premised on its crediting of Dr. Slavin's testimony

[00:30:33] Speaker 02:
that adding that electrode would push the tines out of the trigeminal cistern and render that lead inoperable for trigeminal stimulation, which, as I covered in my opening presentation, is simply the wrong question.

[00:30:48] Speaker 02:
And the flaw in Medtronic's reasoning here, and the board's, is the question this court asks repeatedly, which is that the board didn't ask what a skilled artisan would conclude

[00:31:02] Speaker 02:
upon reading Young and the complementary disclosure of Gerber.

[00:31:07] Speaker 02:
It asked, well, if I stuck an electrode on the end of this lead in Young, it wouldn't work for trigeminal stimulation.

[00:31:16] Speaker 02:
So we're finished here.

[00:31:17] Speaker 02:
That's the wrong framework and the wrong question.

[00:31:20] Speaker 02:
I did want to briefly address the board's rejection of a motivation to combine from the shared problem set of these patents.

[00:31:30] Speaker 02:
It is the case, as noted by the court,

[00:31:32] Speaker 02:
that none of the claims of the 314 or 756 patents recite sacral neuromodulation as its purpose or even in the preamble.

[00:31:42] Speaker 02:
The specification of the 314 and 756 patents has a clear statement in the summary invention that the problem they address is much broader than sacral neuromodulation, that it provides a solution to problems associated with implanting

[00:32:02] Speaker 02:
and maintaining electrical leads in body tissue.

[00:32:05] Speaker 02:
The specification also discloses other uses for its claimed lead beyond sacral neuromodulation.

[00:32:12] Speaker 02:
Says you can use it for neurostimulation in the stomach muscle.

[00:32:17] Speaker 02:
So you're absolutely right, there is no basis to limit the field of invention to sacral neuromodulation.

[00:32:24] Speaker 02:
under either correct person of skill or either rendition of person of skill in the art, the board's adoption of a person of skill in the art in sacral neuromodulation or the broader formulation, the fact that the resultant grafting of an electrode to the tip of Young's lead would result in inoperability for sacral neuromodulation would not prevent a skilled artist from finding motivation to combine.

[00:32:51] Speaker 02:
Thank you.

[00:32:52] Speaker 03:
Thank you to both counsel, the case is submitted.