[00:00:00] Speaker 03:
Okay, the next ordered case is number 20, 1990, neuro and cardiac technologies against the Ivanova Incorporation.

[00:00:13] Speaker 03:
Mr. Burke.

[00:00:17] Speaker 00:
Thank you and may it please the court.

[00:00:20] Speaker 00:
The PTAP's decision in validating the 307 patent should be reversed for at least two significant reasons.

[00:00:26] Speaker 00:
First,

[00:00:27] Speaker 00:
The PTAB lacked substantial evidence for concluding that there was no evidence of secondary considerations of non-obviousness.

[00:00:37] Speaker 00:
Neurocardiac submitted evidence, one, that there was long felt and unresolved need for the inventions of the 307 application.

[00:00:46] Speaker 00:
Additionally, neurocardiac submitted evidence that the commercial success of products infringing the 307 patent had a nexus with the concepts here

[00:00:58] Speaker 00:
And second, the PTAP decision should be reversed because one of ordinary skill in the art would not have a motivation to combine Meadows and Rutecki.

[00:01:09] Speaker 00:
As I will explain a little bit later, the substantial differences in the therapies of Meadows and Rutecki would lead one of ordinary skill in the art not to combine those references.

[00:01:23] Speaker 02:
Tell me if I'm wrong in this understanding.

[00:01:26] Speaker 02:
I thought what was being borrowed from Meadows was the kind of multi-program feature.

[00:01:34] Speaker 02:
How does that have anything to do with whether what you are stimulating is the spine or the vagus nerve?

[00:01:44] Speaker 00:
You are correct, Your Honor, in that the element taken from Meadows is really the multiple prepackaged programs and applied to Ruteki's vagal nerve stimulation system.

[00:01:56] Speaker 00:
Now, it's not merely, our argument at least, is not merely that you can't take a spinal cord stimulation apparatus and then change the leads and apply it to vagal nerve stimulation.

[00:02:10] Speaker 00:
It's more that because of the significant differences in how these work, that the number of prepackaged programs, at least at the time of these prior references, pointed away from using multiple prepackaged programs.

[00:02:26] Speaker 00:
And that comes from Ruteki.

[00:02:28] Speaker 00:
And Ruteki talks about how once the implantable pulse generator is programmed, it continues to operate using that single program until the patient returns to the physician

[00:02:40] Speaker 00:
and the physician or a technician under the control of the physician reprograms the pulse generator.

[00:02:47] Speaker 04:
But the problem is Meadows isn't limited to the SCS treatment, right?

[00:02:52] Speaker 00:
So, Your Honor, in the background of the invention for Meadows, it mentions that the teachings of that application can be applied to different manners of neuromodulation.

[00:03:04] Speaker 00:
Then actually in the specification, it mentions that the methods may be applied to different types of neuromodulation.

[00:03:12] Speaker 00:
But nothing in the specification of METO says or even suggests to one of ordinary skill in the art that you would apply it to vagal nerve stimulation.

[00:03:23] Speaker 00:
And as neurocardiacs expert Dr. Ladd testified, one of ordinary skill in the art would not do that.

[00:03:30] Speaker 00:
because, so the vagal nerve stimulation, it is based on cumulative therapy.

[00:03:38] Speaker 00:
You need the duty cycle repeatedly operating over time before any effects are felt in the patient.

[00:03:45] Speaker 00:
In contrast, the spinal cord stimulation is a constant therapy, and it's meant to have effect almost immediately, because its target is actually the spinal cord, whereas with vagal nerve stimulation...

[00:04:00] Speaker 04:
Do you do it exactly the same way?

[00:04:02] Speaker 04:
But the question is, do you have multiple program systems that one would be motivated to use for VNS?

[00:04:10] Speaker 04:
I mean, doesn't the techie itself disclose a prior system, a patent with multiple program systems?

[00:04:18] Speaker 00:
I don't believe it does, Your Honor, because the PTAB had to rely on Meadows to find the multiple.

[00:04:24] Speaker 04:
But the patent does, in its disclosure of prior hours, list

[00:04:29] Speaker 04:
a system with multiple programs, right?

[00:04:33] Speaker 00:
You may be correct on that, Your Honor, but the PTAP found that that element was not disclosed in Ruteki and had to make the combination between Meadows and Ruteki.

[00:04:45] Speaker 00:
So the main question today here is whether or not there's a motivation to combine these two references.

[00:04:52] Speaker 00:
And as I've been explaining in the key differences between the therapy types,

[00:04:57] Speaker 00:
One would not want to take the multiple programs of Meadows and apply them to Rutecki, even though Meadows may have suggested that multiple programs could reduce the number of trips to the doctor's office to update settings.

[00:05:15] Speaker 00:
Because as in Rutecki, Rutecki, you want the physician to program, and you have to wait over time to see what effect that programming is going to have.

[00:05:24] Speaker 00:
As our expert explained, it's a cumulative therapy.

[00:05:29] Speaker 00:
And when you have cumulative therapy, you don't know the results, whether good or bad, until there's been sufficient time to actually see that effect.

[00:05:37] Speaker 04:
But doesn't Meadows disclose different time parameters for purposes of stimulation?

[00:05:44] Speaker 00:
Your Honor, technically it has terms for treatment time and for, I think, auto cycle is the other.

[00:05:52] Speaker 00:
But that does not fall within the

[00:05:55] Speaker 00:
on and off time parameters claimed in the 307 pattern.

[00:05:59] Speaker 00:
As the PTAP correctly found, that requires a duty cycle.

[00:06:03] Speaker 00:
And in meadows, those parameters merely indicate the start of a treatment that continues until it ends.

[00:06:12] Speaker 00:
It's not a long span during which

[00:06:16] Speaker 00:
the on and off constantly flips in a duty cycle as required by the claims of the three.

[00:06:22] Speaker 04:
But doesn't the mere fact that it suggests giving patients control imply that it can be on and off?

[00:06:33] Speaker 00:
No, Your Honor.

[00:06:33] Speaker 00:
Even though it may suggest that it can, the more important issue is

[00:06:41] Speaker 00:
whether or not one of ordinary skill will look at that and think, yes, I should.

[00:06:46] Speaker 00:
It's not just can, it should.

[00:06:49] Speaker 00:
And one of ordinary skill in the art would appreciate that with the vagal nerve stimulation, you want the physician tuning it because the cumulative therapy means we don't know immediately.

[00:07:00] Speaker 04:
What would have been motivated with a reasonable expectation of success, right?

[00:07:06] Speaker 04:
I don't know where you get the should part from.

[00:07:09] Speaker 00:
Well, the standard is whether, yes, you're correct.

[00:07:12] Speaker 04:
They would be motivated.

[00:07:13] Speaker 00:
They would be motivated and have an expectation of success.

[00:07:17] Speaker 00:
Having multiple programs does not indicate one of ordinary skill in the art, but that would be a successful mode of therapy.

[00:07:26] Speaker 00:
And that is because you don't want the patient

[00:07:29] Speaker 00:
toggling around with all of these things, given the sensitivity of the vagal nerve.

[00:07:34] Speaker 00:
And Dr. Lad testified that overstimulation of the vagal nerve can permanently damage that nerve and cause serious harm to the patient.

[00:07:43] Speaker 00:
That evidence is not disputed by Levonova.

[00:07:47] Speaker 00:
So one ordinary skill in the art would not have made that combination.

[00:07:51] Speaker 00:
But notwithstanding that, the PTAB aired because

[00:07:55] Speaker 00:
It did not properly credit neuro and cardiac's evidence of secondary considerations of non-obviousness.

[00:08:02] Speaker 00:
Most importantly, neuro and cardiac introduced evidence that there was long-felt but unresolved need for the invention of the 307 application.

[00:08:12] Speaker 00:
And Levanova during briefing before the PTAB did not address that point.

[00:08:17] Speaker 00:
They exclusively focused on the nexus requirement for commercial success of the invention.

[00:08:24] Speaker 00:
And so the only evidence is that there was long felt but unresolved need.

[00:08:28] Speaker 00:
And that evidence was a prior application that mentioned multiple prepackaged programs and an external pulse generator.

[00:08:37] Speaker 04:
So but the long felt need, the only evidence you have is that six-year gap, right?

[00:08:42] Speaker 00:
It is the six-year gap from the application in 1998 and when the first application, which was Neuron Cardiacs, caught in 2004.

[00:08:50] Speaker 04:
Okay, but there's nothing, you don't point to anything, either expert testimony or data out there saying we're trying to figure this problem out.

[00:09:02] Speaker 00:
Nothing outside of Dr. Ladd's statement that there was long felt and unsolved need.

[00:09:08] Speaker 00:
You're correct.

[00:09:08] Speaker 00:
We did not point to anything in the briefing showing any sort of statistical data or anything of that nature.

[00:09:15] Speaker 04:
But I will note that... Did you show that any other people had been trying and failing?

[00:09:21] Speaker 00:
We did not point to anything specifically beyond the fact that there was a general need for the implantable devices and that

[00:09:32] Speaker 00:
is derived from Dr. Ladd's testimony.

[00:09:35] Speaker 00:
And additionally, even beyond that, we also have the commercial success of products infringing on the 307 claims.

[00:09:44] Speaker 04:
But you say that, but there has been no determination of infringement, has there?

[00:09:51] Speaker 04:
This is just your allegation that it falls.

[00:09:53] Speaker 00:
Well, correct, Your Honor.

[00:09:55] Speaker 00:
And we're not aware of any cases saying that to establish commercial success, you first need a judicial determination of infringement, just evidence of infringement.

[00:10:07] Speaker 00:
And in a parallel litigation, neurocardiacs submitted infringement claims.

[00:10:12] Speaker 00:
mapping Levenova's product to the claims of the 307 patent.

[00:10:19] Speaker 04:
So you're saying that there's some indication that their product has had success?

[00:10:27] Speaker 00:
Correct.

[00:10:27] Speaker 00:
And that comes from Levenova's own documentation.

[00:10:30] Speaker 00:
I cannot recall the year from which that was, but they reported

[00:10:35] Speaker 00:
an increase in sales due to adoption of the Cintiva product.

[00:10:40] Speaker 00:
And the Cintiva product is what Neurocardiac mapped in their infringement charts.

[00:10:47] Speaker 00:
And although a later sentence mentions that Levonova also had increased expenses due to direct to consumer marketing, that statement was with respect to their neuromodulation.

[00:11:01] Speaker 04:
But you don't in any way quantify what that success is, right?

[00:11:04] Speaker 04:
You just say they had

[00:11:05] Speaker 04:
increased sales in Europe and Japan?

[00:11:09] Speaker 00:
Correct.

[00:11:10] Speaker 00:
We don't put a dollar value on it, and we only have sort of the publicly available evidence that they have published.

[00:11:18] Speaker 00:
And if I recall correctly, they had a percentage amount of year-over-year growth, and they attributed it to adoption of the Cintiva product, which is what Neurocardiac has alleged infringes the 307 patent.

[00:11:33] Speaker 00:
and going back to the statement about increased costs.

[00:11:39] Speaker 02:
Were there other features in the Centiva VNS therapy system, the accused system, that might have been attractive to patients and doctors and whoever else is making the decision about installing one of these?

[00:11:58] Speaker 00:
I don't think there is much information on that point in the record.

[00:12:02] Speaker 02:
Would that not have been part of your burden to show a nexus to the specific claim requirements here?

[00:12:12] Speaker 00:
Yes, Your Honor, we must show a nexus between the claim and the alleged commercial success.

[00:12:19] Speaker 00:
And we did that in submitting Dr. Ladd's declaration.

[00:12:23] Speaker 00:
He mentioned that he reviewed all of the exhibits to Livanova's petition to the IPR.

[00:12:29] Speaker 00:
And that included our infringement charge from the parallel district court litigation.

[00:12:34] Speaker 00:
Thus, when he was concluding that there was a nexus between the commercial success of the Cintiva product

[00:12:42] Speaker 00:
and the 307 patent claims, he was doing so in view of everything that he reviewed, which included those infringement charts.

[00:12:51] Speaker 04:
Did he look at anything else relating to the Centiva product, like other features of it, or the advertising that was put in place, or the market that they were tapping into, which was outside of the country?

[00:13:04] Speaker 00:
Your Honor, he did not expound upon whether he reviewed any other data outside of the Levanova brochures and literatures that we cited in the record and items that were part of the petition.

[00:13:21] Speaker 00:
So no, he did not do a full economic analysis or a full analysis of the Cintiva product itself.

[00:13:29] Speaker 00:
However, he did obviously review the infringement

[00:13:34] Speaker 00:
the infringement chart and link those to the commercial success, which Levenova has admitted is due to adoption of the Centiva product.

[00:13:44] Speaker 00:
And in Levenova's briefing, rather, they try to attack that mainly by looking at the fact that they had increased advertising costs.

[00:13:56] Speaker 00:
And as I explained,

[00:13:58] Speaker 00:
That was not directly advertising costs for the Cintiva product, but rather an entire neuromodulation department.

[00:14:05] Speaker 00:
Thus, the fact that an increase attributed to the Centiva products specifically shows that it's more than just an increase in advertising dollars.

[00:14:18] Speaker 00:
Because if that can all be attributed to the increased advertising spend, you would have expected the entire business unit to have seen increased sales, yet they singled out the Centiva product alone.

[00:14:31] Speaker 04:
Let me just ask one more question before you're all out of time.

[00:14:33] Speaker 04:
But you rely on Dr. Ladd, and you say he said he looked at everything.

[00:14:39] Speaker 04:
But he didn't actually go through the infringement chart and express an opinion that there is infringement, did he?

[00:14:48] Speaker 00:
Your Honor, he did not go through and write affirmative statements as to each claim element.

[00:14:55] Speaker 04:
He doesn't even mention the infringement chart.

[00:14:57] Speaker 04:
He just said, I looked at everything.

[00:14:59] Speaker 00:
Correct, Your Honor.

[00:15:01] Speaker 03:
OK, thank you.

[00:15:02] Speaker 03:
We'll stay here a little time.

[00:15:04] Speaker 03:
Let's hear from the other side.

[00:15:17] Speaker 03:
Mr. Jakes?

[00:15:24] Speaker 01:
Good morning.

[00:15:25] Speaker 01:
May it please the court?

[00:15:26] Speaker 01:
This is a substantial evidence case.

[00:15:29] Speaker 01:
There aren't really any disputed legal issues.

[00:15:32] Speaker 01:
The parties aren't challenging claim construction the only question is was there substantial evidence to support the board's findings and Here and the board's very thorough opinion.

[00:15:43] Speaker 04:
There was more than enough evidence to conclude that the claims would have been obvious Stimulating vagus nerve is very different than stimulating muscles, right?

[00:15:55] Speaker 04:
I mean it could be dangerous No, your honor

[00:15:59] Speaker 01:
I don't agree it's very different.

[00:16:01] Speaker 01:
They use the same pulse generator and the SCS system, the spinal cord system, it's stimulating a nerve as well.

[00:16:09] Speaker 01:
It talks about neurostimulation.

[00:16:11] Speaker 01:
These devices, they're not really all that different than pacemakers.

[00:16:16] Speaker 01:
supply a chain of pulses to whatever.

[00:16:19] Speaker 04:
But the expert testimony was that with respect to the vagus nerve, you have to be very careful that the stimulation is carefully controlled.

[00:16:28] Speaker 01:
That's true.

[00:16:29] Speaker 01:
Yes.

[00:16:30] Speaker 01:
And there's no disagreement about that.

[00:16:32] Speaker 01:
But that doesn't mean that the patient can't have some control to change parameters.

[00:16:37] Speaker 01:
In fact, that's what Levonova's product does.

[00:16:40] Speaker 01:
That's the product that it does today.

[00:16:43] Speaker 01:
And so the suggestion that

[00:16:45] Speaker 01:
you wouldn't have multiple programs with some limited patient control because it would be dangerous.

[00:16:51] Speaker 01:
Of course, those are very contained parameters that the doctor gives the patient control over, such as increase the stimulation or increase the frequency.

[00:17:03] Speaker 01:
Those programs, I mean, they obviously work.

[00:17:06] Speaker 01:
They are working today.

[00:17:07] Speaker 01:
So the idea that it would have been dangerous because you wouldn't ever want to

[00:17:12] Speaker 01:
put multiple programs into the device.

[00:17:15] Speaker 04:
Of course, you're asking us to just engage in hindsight here.

[00:17:18] Speaker 04:
We figured it out later, six years later, so therefore it must not have been, it must have been something everybody would have thought to do.

[00:17:28] Speaker 01:
I think the teaching in Meadows is enough.

[00:17:32] Speaker 01:
There's a direct

[00:17:34] Speaker 01:
express suggestion that that system could be used with various types of neural stimulation systems.

[00:17:43] Speaker 01:
And there's nothing in there that says don't use this with the vagus nerve.

[00:17:47] Speaker 04:
Right.

[00:17:47] Speaker 04:
When you say there's a direct statement, it says various stimulation systems.

[00:17:51] Speaker 04:
So they list several.

[00:17:53] Speaker 04:
Where does vagus nerve fall in that list?

[00:17:56] Speaker 01:
It's a neural stimulation system.

[00:17:58] Speaker 01:
It's stimulating a nerve.

[00:18:00] Speaker 01:
And that is exactly what happens.

[00:18:02] Speaker 01:
Now, the other point in Meadows, it also says that it could be used with single electrodes as opposed to multiple electrodes.

[00:18:11] Speaker 01:
Well, the vagus nerve system is a single electrode system.

[00:18:15] Speaker 01:
And so the differences you would have between stimulating the spinal cord and the vagus nerve, it already accounts for that.

[00:18:25] Speaker 01:
So these programs are not that different.

[00:18:28] Speaker 01:
There's nothing that says the frequency, amplitude, these parameters are so different that you wouldn't apply one to the other.

[00:18:35] Speaker 01:
They have to be set for the particular application.

[00:18:38] Speaker 01:
But that's directly what Meadows says.

[00:18:41] Speaker 01:
I mean, the teaching of Meadows, the whole patent is directed to multiple programs.

[00:18:46] Speaker 01:
And that's really the only difference from the Rutecki system, which is a vagus nerve system.

[00:18:54] Speaker 01:
and what is claimed here.

[00:18:57] Speaker 01:
And as I think, Your Honor, recognize, even in Rutecki, it does cite to an earlier patent, but also suggests some patient control in terms of frequency and amplitude for vagus nerve stimulation.

[00:19:11] Speaker 01:
That's that earlier Baker patent.

[00:19:13] Speaker 01:
So what we're left here with is factual findings by the board that there was a motivation to combine.

[00:19:19] Speaker 01:
We have Dr. Miron's very lengthy declaration, which goes into all those reasons.

[00:19:24] Speaker 01:
The board looked at those reasons, found for multiple reasons there would be a motivation to combine the similarities between the systems.

[00:19:32] Speaker 01:
Primarily, motivation would be for the very same reason that Meadows teaches, multiple programs, so that the patient could have some control without having to go to the doctor every time to reprogram it.

[00:19:46] Speaker 01:
And that these systems were not so different that they couldn't be combined.

[00:19:51] Speaker 01:
Now, the other side made an argument throughout their briefs that the board found they could be combined, but not that they would.

[00:19:58] Speaker 01:
Of course, the board said would on multiple instances in its opinion.

[00:20:05] Speaker 01:
In saying that the teachings could be combined, the court was addressing Neuro's argument that they were incompatible and that they would somehow never be combined.

[00:20:15] Speaker 01:
And the board said, no, it's really not that big of a leap.

[00:20:18] Speaker 01:
In fact, both experts agreed that it would require only minimal changes to the actual devices in order to combine the two.

[00:20:28] Speaker 02:
Can you remind me, what did your experts say on the specific question whether for vagus nerve stimulation doctors would not want to place multiple options in the patient's hands?

[00:20:44] Speaker 02:
I don't think our experts said that.

[00:20:47] Speaker 02:
No, that's kind of their point.

[00:20:50] Speaker 02:
What's that?

[00:20:50] Speaker 02:
I think that that was their argument.

[00:20:53] Speaker 02:
The question is, what did your experts say in response to that?

[00:20:57] Speaker 01:
Oh, I'm not sure that our expert did respond to that.

[00:21:02] Speaker 01:
Our expert did go through all the reasons there was a reason to combine them.

[00:21:06] Speaker 01:
And that, in fact, the difference was they were compatible.

[00:21:11] Speaker 01:
They could be combined.

[00:21:13] Speaker 01:
And the notion that

[00:21:15] Speaker 01:
they would be somehow dangerous.

[00:21:18] Speaker 01:
I don't remember if that was specifically addressed by our expert.

[00:21:24] Speaker 01:
On the secondary considerations, there's really, if you look at what was submitted, there is barely anything there.

[00:21:34] Speaker 01:
On the long felt need, there is

[00:21:37] Speaker 01:
An earlier patent by the same inventor that discloses everything except it's an external device.

[00:21:44] Speaker 01:
It's vague as nerve stimulation.

[00:21:46] Speaker 01:
It also has multiple programs.

[00:21:49] Speaker 01:
That's somewhat contrary.

[00:21:51] Speaker 02:
Would I be correct in thinking that the patient could abuse that one too?

[00:21:55] Speaker 02:
It's just that it's not inside the body, it's outside the body.

[00:21:58] Speaker 01:
Yes, it was external, yes.

[00:21:59] Speaker 01:
And it also teaches multiple programs.

[00:22:02] Speaker 01:
But it was an external device.

[00:22:03] Speaker 01:
The only difference was that it wasn't implantable.

[00:22:06] Speaker 01:
And if you look at the gap, whether it's six years or less, I think that patent issued in 2001, and they filed their next application the next year.

[00:22:19] Speaker 02:
But they're running from the application date of the first patent.

[00:22:23] Speaker 01:
Sure.

[00:22:24] Speaker 01:
But it wasn't publicly known.

[00:22:26] Speaker 01:
It was several years before.

[00:22:28] Speaker 01:
And for a long-filled need, there has to be something generally recognized that this is a problem.

[00:22:34] Speaker 01:
I mean, that's what you look for, not just that nobody did it.

[00:22:37] Speaker 01:
And that's why the passage of time is not enough, because that's just the argument that, well, during this time, nobody did it.

[00:22:44] Speaker 01:
There has to be a recognition of the problem.

[00:22:46] Speaker 01:
And usually, somebody tried to solve it, and they were having difficulty with it.

[00:22:52] Speaker 01:
So there's no real evidence to support that.

[00:22:55] Speaker 01:
Their expert did say, well, I think there's a long-felt need.

[00:23:00] Speaker 01:
There's really nothing to back that up.

[00:23:02] Speaker 02:
What is the difference between your affirmative motivation evidence that skilled artisans would have recognized there'd be a benefit to patient control, reduced number of visits to the doctor and so on, and a recognition of the problem?

[00:23:21] Speaker 01:
and a recognition of the problem.

[00:23:24] Speaker 02:
Why doesn't your own evidence of recognized benefit from doing this constitute evidence of recognition of the problem that took not very long time, but let's stipulate it was a long time for purposes of this question to solve?

[00:23:45] Speaker 01:
Well, certainly there was a reason to combine them.

[00:23:50] Speaker 01:
If I follow your logic, I think anywhere there's a motivation to combine.

[00:23:54] Speaker 01:
That might be true.

[00:23:55] Speaker 01:
There would be a long felt need.

[00:23:56] Speaker 01:
I don't think that's quite right.

[00:23:57] Speaker 01:
Well, it would depend on how long.

[00:23:59] Speaker 01:
That's right.

[00:24:00] Speaker 01:
I suppose it would.

[00:24:03] Speaker 01:
But most inventions do try to solve some need.

[00:24:06] Speaker 01:
And where there's a motivation to combine, if there is a reason, I don't think that implies a long felt need.

[00:24:15] Speaker 01:
It could be something that nobody ever thought was needed.

[00:24:19] Speaker 01:
if it was suggested by the prior art, and there was a reason to do it, then that would still satisfy it.

[00:24:27] Speaker 01:
On commercial success, what we have is there are experts, basically two sentences, one saying our product was a commercial success.

[00:24:38] Speaker 04:
Well, do you use your product as a commercial success?

[00:24:45] Speaker 01:
Not in the sense that you'd have to have to prove it.

[00:24:48] Speaker 04:
Is it a commercial success or is it not?

[00:24:50] Speaker 01:
It's a successful product.

[00:24:53] Speaker 01:
There's no doubt about that.

[00:24:54] Speaker 01:
But when you say there's commercial success, that implies there's something that goes with that in this context.

[00:25:04] Speaker 01:
And that's why simply saying a product is successful is not enough.

[00:25:07] Speaker 01:
to show commercial success for purposes of secondary consideration.

[00:25:11] Speaker 04:
So what else would they have had to show other than, you know, assuming your product infringes the patent, what would they have had to show other than the fact that your product is a commercial success?

[00:25:24] Speaker 01:
Well, they'd have to show what that commercial success was.

[00:25:26] Speaker 01:
Was it a, there's no quantification.

[00:25:29] Speaker 01:
There's, you know, is it, did it replace an earlier product?

[00:25:34] Speaker 01:
Is that where the sales came from?

[00:25:36] Speaker 01:
That's generally not a commercial success.

[00:25:38] Speaker 01:
If all you're doing is having an updated product, they would have to show, of course, a nexus, that any increase that would have to be something more than minimal was a... Well, this was a new product, right?

[00:25:52] Speaker 01:
Well, yes, but it was replacing an existing product, yes.

[00:25:55] Speaker 04:
That's a product that wasn't programmable, right?

[00:25:59] Speaker 01:
It was programmable by the doctor.

[00:26:00] Speaker 04:
Right, but not by the patient.

[00:26:02] Speaker 04:
That's the whole point.

[00:26:03] Speaker 01:
There weren't multiple programs.

[00:26:04] Speaker 01:
Yes, they introduced the feature of multiple programs in 27 or 28.

[00:26:09] Speaker 04:
Which is the whole invention that's disclosed in the pact, right?

[00:26:14] Speaker 01:
Well, that's the invention that's disclosed in Meadows as well from 1998.

[00:26:18] Speaker 01:
So yes, multiple programs.

[00:26:21] Speaker 01:
They did introduce that feature.

[00:26:23] Speaker 03:
Well, they did show that it did something that prior products didn't do.

[00:26:28] Speaker 03:
Isn't that correct?

[00:26:29] Speaker 01:
That's true.

[00:26:30] Speaker 01:
Yes, the product was different than its earlier product.

[00:26:33] Speaker 01:
And as I think there wasn't any showing that there weren't additional features in this new product that could have had something to do with it.

[00:26:42] Speaker 01:
What we're left with is one statement in the Libanova's 10Q that says sales of this year were better than last year.

[00:26:52] Speaker 01:
We introduced this new product.

[00:26:53] Speaker 01:
And then the following sentence, it also talks about increased sales and marketing expenses that had kept some of that income down.

[00:27:01] Speaker 01:
That's pretty weak.

[00:27:03] Speaker 01:
That's, I mean, without any more, I don't think this court had said that's the kind of evidence you need for commercial success to overcome what is a strong case of obviousness in any event.

[00:27:15] Speaker 01:
The board looked at that and said, look, we'll accept there's a nexus here.

[00:27:19] Speaker 01:
It's not enough.

[00:27:20] Speaker 01:
You say it's overwhelming.

[00:27:21] Speaker 01:
We don't see it.

[00:27:23] Speaker 01:
It doesn't overcome this case of obviousness in any event.

[00:27:28] Speaker 01:
On the nexus question, we did challenge the nexus.

[00:27:32] Speaker 01:
What they have in their expert's declaration is one sentence.

[00:27:36] Speaker 01:
There is a nexus.

[00:27:38] Speaker 01:
This court's case on nexuses is pretty extensive about what needs to be done.

[00:27:43] Speaker 01:
And a bare statement that there is a nexus isn't enough.

[00:27:47] Speaker 01:
whether or not their claims cover our product.

[00:27:51] Speaker 01:
We've obviously disputed that in the litigation.

[00:27:54] Speaker 01:
What was attached was a claim chart that were their contentions.

[00:27:59] Speaker 01:
There was no evidence that the expert didn't swear to that.

[00:28:02] Speaker 01:
He didn't say, I looked at the product, but I believe it infringes.

[00:28:06] Speaker 01:
It's attorney argument.

[00:28:07] Speaker 01:
There's any contentions that are submitted in a district court case.

[00:28:11] Speaker 01:
We actually submitted it with our petition for the purpose of showing what claim constructions.

[00:28:16] Speaker 01:
that they were proposing.

[00:28:18] Speaker 01:
That on itself just attached to our petition.

[00:28:23] Speaker 01:
That's not evidence.

[00:28:25] Speaker 01:
That's just their arguments that they made.

[00:28:27] Speaker 01:
Their suggestion, well, their expert looked at everything.

[00:28:31] Speaker 01:
He didn't say that.

[00:28:32] Speaker 01:
He has one sense in his declaration that says there's a nexus.

[00:28:37] Speaker 01:
And if that's enough, the threshold for commercial success and nexus will be so low that it will take virtually nothing for someone to assert that.

[00:28:46] Speaker 02:
And just remind me, what evidence did you submit in answer to the assertion of commercial success?

[00:28:55] Speaker 01:
We argued that they hadn't proved nexus.

[00:28:58] Speaker 02:
An argument, an attorney's argument?

[00:28:59] Speaker 01:
Yes.

[00:29:00] Speaker 01:
We didn't submit anything alternatively.

[00:29:02] Speaker 01:
It was their burden to put forth that evidence, and we didn't think they had made the showing.

[00:29:09] Speaker 01:
The board agreed with us, made those findings that they hadn't produced enough evidence.

[00:29:14] Speaker 01:
And that brings us back, that's why this is a substantial evidence case.

[00:29:17] Speaker 01:
There was more than enough evidence to support the board's findings on motivation to combine and rejecting the secondary considerations.

[00:29:27] Speaker 01:
Their expert may have said something different, but that's not the standard.

[00:29:30] Speaker 01:
And the board found more than these references could have been combined, but that a person of ordinary skill in the art would have combined them for the very reason that was given in Meadows.

[00:29:45] Speaker 03:
Thank you.

[00:29:48] Speaker 03:
Thank you.

[00:29:57] Speaker 03:
Thank you.

[00:30:07] Speaker 00:
Thank you.

[00:30:08] Speaker 00:
Just a few brief points.

[00:30:10] Speaker 00:
While our expert, Dr. Ladd, never specifically said that he looked at the infringement contentions, at appendix 43-42, there's a discussion where, during the PTAP proceedings, our expert claimed that he reviewed all of the exhibits, and that exhibit included those infringement contentions.

[00:30:31] Speaker 00:
So he's not pulling this stuff out of thin air.

[00:30:34] Speaker 00:
He did review those contentions, he did consider them, and then he made the conclusion that there was a nexus between the alleged infringement and the commercial success of the Cintiva product.

[00:30:48] Speaker 00:
Furthermore, whether or not the Cintiva product has shown that it's possible to use the multiple prepackaged programs in the vagal nerve stimulation is not relevant.

[00:31:00] Speaker 00:
Because we must look back to the time of these prior art references to determine whether or not one of ordinary skill in the art would have had the expectation that it would have been safe.

[00:31:13] Speaker 00:
And the evidence does not show that.

[00:31:16] Speaker 00:
All of the evidence shows that there is danger in overstimulating the vagal nerve.

[00:31:22] Speaker 00:
And Levenova's expert agrees that overstimulation is dangerous.

[00:31:26] Speaker 00:
Therefore, one ordinary skill in the art would not have made that combination.

[00:31:32] Speaker 00:
And finally, yes, this is a substantial evidence standard of review with all these factual issues.

[00:31:40] Speaker 00:
But at least on the point of long-felled and unsolved need,

[00:31:45] Speaker 00:
The only evidence on that point was that there was long felt and unsolved need.

[00:31:51] Speaker 00:
There was evidence that multiple prepackaged programs might be useful in the vagal nerve setting in sort of the prior reference that one of the inventors of the 307 patent filed.

[00:32:05] Speaker 00:
And the fact that there was a six year gap between

[00:32:08] Speaker 00:
when that came out and when any of these implantable pulse-generating bale nerve stimulators were actually released as evidence of non-obviousness.

[00:32:21] Speaker 00:
If there are no further questions, we will see the rest of our time.

[00:32:26] Speaker 03:
Okay.

[00:32:26] Speaker 03:
Thank you.

[00:32:27] Speaker 03:
Thank you.

[00:32:27] Speaker 03:
Thank you.

[00:32:27] Speaker 03:
Thanks to both counsels.

[00:32:29] Speaker 03:
The case is taken under submission.

[00:33:03] Speaker 03:
Okay, will council come forward for Jones against the United States?