[00:00:03] Speaker 02:
We have four argued cases this morning.

[00:00:06] Speaker 02:
Mr. Wolf, are you ready to proceed?

[00:00:08] Speaker 03:
Thank you, Your Honor.

[00:00:11] Speaker 03:
May it please the Court, Matthew Wolf for Boston Scientific.

[00:00:15] Speaker 03:
The board's findings that a truly significant medical invention, one that's already saved thousands of lives, was obvious is rife with legal error and hindsight bias.

[00:00:29] Speaker 03:
I want to focus, broadly speaking, on two of those legal errors.

[00:00:34] Speaker 03:
First, the board's one-sentence conclusion that there was a reasonable expectation of success.

[00:00:39] Speaker 03:
And second, its dismissal of the overwhelming evidence of the secondary indicia of non-obviousness.

[00:00:45] Speaker 02:
A little housekeeping question.

[00:00:46] Speaker 02:
Do you agree that claim one is representative?

[00:00:49] Speaker 03:
Yes, Your Honor.

[00:00:53] Speaker 03:
In terms of the reasonable expectation of success, under Honeywell and its progeny, the board must make a specific finding that a person of skill in the art would have in 2004 had a reasonable expectation of success in combining the prior art without hindsight.

[00:01:11] Speaker 03:
The sum total of the board's conclusion in this regard is found on page 68 of the final written decision.

[00:01:17] Speaker 02:
On page 66, 268 in the blue brief,

[00:01:21] Speaker 02:
You argue that Sapien 3 embodies your claimed invention.

[00:01:25] Speaker 02:
Yes, Your Honor.

[00:01:26] Speaker 02:
Entitling you to a presumption of nexus, because Sapien 3 has to have, quote, a replacement valve commissure support element attached to the expendable anchor, close quote.

[00:01:39] Speaker 02:
Yes, Your Honor.

[00:01:39] Speaker 02:
Otherwise, the device would fall apart.

[00:01:42] Speaker 02:
The intervener says that's waived because you didn't raise it below.

[00:01:46] Speaker 02:
Is it true?

[00:01:48] Speaker 02:
If it's not true, where'd you raise it?

[00:01:50] Speaker 03:
Your Honor, it is not true.

[00:01:51] Speaker 03:
It is raised, for example, at the hearing itself before the board at A965, where that precise argument was made.

[00:02:02] Speaker 03:
It was made in a number of different ways, in fact.

[00:02:06] Speaker 03:
And the argument is simply, the commissure support element must be attached to the stent.

[00:02:11] Speaker 03:
In this case, there's a clear structural window that acts to hold the commissures, which are just the ends of the valves.

[00:02:20] Speaker 03:
It's clearly a structure distinct from this, and we have the pictures in the brief, the surrounding latticework of the stent.

[00:02:28] Speaker 03:
The board made a fundamental plane construction error.

[00:02:30] Speaker 03:
It found that if you use the word attached, that means you must have an A and a B separate at some point that are then brought together.

[00:02:39] Speaker 03:
in the same way that a handle of a water pitcher is deemed attached if it's screwed on, but somehow would not be deemed attached if it was integrally made in the forging process.

[00:02:49] Speaker 03:
This court has found time and time again that attached doesn't mean a method of manufacture, it means that there must be a connection, and there's clearly a connection between the commisher window and the rest of the stent latticework.

[00:03:01] Speaker 03:
So the sum total of the reasonable expectation of success analysis is, quote, and this is on page 68, A68, we agree with Petitioner that the proven capabilities of sealing suggested by the success of fabric seals in the stent graph context supports an expectation of success where the same features to be applied to replacement valves.

[00:03:25] Speaker 03:
that is legally insufficient under InTouch and similar cases where the court has said they have to explain, the board has to explain why it finds something, the burden is on the board.

[00:03:39] Speaker 03:
Even more troubling, it's tautological.

[00:03:41] Speaker 03:
It's saying because it worked with AAA devices, with the big relatively healthy

[00:03:46] Speaker 03:
abdominal aortic valves, it would work in this much different environment.

[00:03:52] Speaker 03:
And that's just not what the evidence suggests.

[00:03:55] Speaker 03:
But more importantly, the burden was on the board to explain why it shows that evidence and it simply doesn't do so.

[00:04:00] Speaker 03:
On that basis alone, remand would be appropriate.

[00:04:03] Speaker 03:
On that basis alone.

[00:04:05] Speaker 03:
But we actually went below and explained why you wouldn't have a reasonable expectation of success.

[00:04:10] Speaker 03:
And broadly speaking, they fall into three categories.

[00:04:13] Speaker 03:
First, the anatomy of the aortic valves are very different than the anatomy of the heart valves.

[00:04:21] Speaker 03:
The simple reason is because in our procedure, the TAVI procedure, the old calcified valves are pushed back.

[00:04:28] Speaker 03:
And you have to account for that when you're trying to deal with leakage.

[00:04:31] Speaker 03:
There is no such problem or issue with the AAA valves.

[00:04:35] Speaker 03:
And the board is completely silent on this undisputed, unambiguous anatomical difference.

[00:04:41] Speaker 03:
At least explain to us why it is that you say we can take one from column A and one from column B when column A and column B are addressing very different anatomies.

[00:04:50] Speaker 03:
The second issue, calcification, we discussed this at length in our brief.

[00:04:54] Speaker 03:
I just want to explain that it was undisputed.

[00:04:57] Speaker 03:
undisputed that the calcifications in the heart are different than the calcifications in the AAA context.

[00:05:03] Speaker 03:
The board's response to this is, well, in the corner case, in that rare instance, you might have a healthy valve.

[00:05:09] Speaker 03:
But where is the law that says you have a motivation to combine features for the rare instance?

[00:05:14] Speaker 03:
As their own expert, or rather petitioner's expert, Dr. Buller acknowledged, you want TAVR to work in a calcified environment.

[00:05:23] Speaker 03:
There is no evidence that anyone in 2004 thought AAA devices, the seals around them, would work in a calcified environment.

[00:05:31] Speaker 00:
As I understand it, both Thornton and Elliott, those references talk about calcified tissue, and Dr. Buller pointed that out, and I can't remember, maybe it was the Elliott reference that talks about

[00:05:44] Speaker 00:
Well, when we have this flared skirt like this, the peripheral edges of that skirt are able to displace into whatever the gaps that exist due to the calcified tissues or irregular shapes.

[00:06:04] Speaker 00:
And so, therefore, it's successfully able to occlude

[00:06:09] Speaker 00:
and stop leakage of blood around the rim of the implant.

[00:06:15] Speaker 03:
Yes, Your Honor.

[00:06:16] Speaker 03:
And Dr. Manganiro and Dr. Brecker explained that calcification in the healthy artery in the AAA context is radically different than calcification in the heart.

[00:06:25] Speaker 03:
And when we confronted Dr. Buller at his deposition, and this is, we cited out the whole Q&A in our briefs, when we said, look, yeah, calcification, the word appears in both places, but it means something very different in these two contexts.

[00:06:38] Speaker 03:
What do you say to that?

[00:06:40] Speaker 03:
He said, I haven't analyzed it.

[00:06:42] Speaker 03:
I don't think anybody has.

[00:06:43] Speaker 03:
Well, in fact, Dr. Mangonaro, who actually lived in the AAA world, unlike Dr. Buller, had explained it, and it remains unrebutted to this day in this case.

[00:06:52] Speaker 00:
And didn't Dr. Brecker say something about how the gaps can be very small?

[00:06:59] Speaker 00:
In the I guess the disease valve that you're trying to insert the replacement valve into something as small as 0.1 millimeters.

[00:07:09] Speaker 03:
Yes, your honor.

[00:07:09] Speaker 03:
And this kind of goes to that error.

[00:07:11] Speaker 03:
I was talking about a minute ago.

[00:07:12] Speaker 03:
There is no doubt that.

[00:07:15] Speaker 03:
In the corner case, the extreme case, the particularly healthy heart valve or the particularly unhealthy AAA valve, there might be some overlap.

[00:07:27] Speaker 03:
But the question we have is would one of skill and the art be motivated to combine?

[00:07:32] Speaker 03:
And you're not motivated to combine A and B to solve the corner case.

[00:07:37] Speaker 03:
And Dr. Buller acknowledged that.

[00:07:38] Speaker 03:
You want to treat the calcification of the situation in front of you.

[00:07:43] Speaker 03:
And so I think this is a legal error by the board to suggest that because there are extreme cases in one or the other of overlap, that that satisfies their burden of showing motivation to combine.

[00:07:53] Speaker 03:
No, the question is, would one of them, still in the arts, say, aha, those AAA seals will solve my problem in the heart?

[00:08:01] Speaker 03:
And they wouldn't, because at their core, typically, they are very different problems.

[00:08:07] Speaker 03:
The last issue with this regard is it goes to the experts, and I don't want to be flippant here, Your Honors, but if we're talking about operating systems, for example, and one person brings in Bill Gates and someone else brings up a grad student from a local university,

[00:08:25] Speaker 03:
who might meet the minimal definition of a person of skill in the art.

[00:08:31] Speaker 03:
I can envision a case where you'd say, I'm going to reject Bill Gates's opinion over this grad student, but you owe an explanation for why you did that.

[00:08:39] Speaker 03:
And time and time and time again, this board chose Dr. Buller over Doctors Manganaro and Brecker, despite the fact that the latter are the Bill Gates's of this industry, and Dr. Buller, while an eminent surgeon, had never performed a triple A procedure.

[00:08:52] Speaker 02:
You agree.

[00:08:53] Speaker 02:
That he met the qualifications as an expert.

[00:08:56] Speaker 03:
At the bare minimum, yes.

[00:08:59] Speaker 03:
The issue is not exclusion.

[00:09:00] Speaker 03:
The issue is, and again, this court has said, if you're going to choose expert A over expert B, you've got to tell us why you chose them.

[00:09:06] Speaker 03:
And particularly here where we have

[00:09:09] Speaker 03:
extremely qualified experts who lived in this world at the time, who are describing the anatomy versus someone that only knows this stuff because he read it in a book.

[00:09:19] Speaker 03:
At least the board has to explain why they chose Dr. Buller over Doctors Manganaro and Bricker.

[00:09:24] Speaker 03:
And they just don't.

[00:09:25] Speaker 03:
They just say, we did.

[00:09:26] Speaker 03:
We believe Dr. Buller.

[00:09:27] Speaker 03:
Well, why?

[00:09:28] Speaker 03:
He doesn't have the experience that the others do.

[00:09:30] Speaker 03:
He doesn't have either now or at the time.

[00:09:33] Speaker 03:
He didn't work in both worlds.

[00:09:35] Speaker 03:
He only knows.

[00:09:36] Speaker 03:
He's only won a personal skill in the art because he read the book.

[00:09:39] Speaker 02:
All they said was, he's an expert.

[00:09:41] Speaker 02:
Yes.

[00:09:42] Speaker 02:
We believe him.

[00:09:44] Speaker 03:
And you should defer to us because of that.

[00:09:45] Speaker 03:
That's right, Your Honor.

[00:09:46] Speaker 03:
And I don't believe that's sufficient under this court.

[00:09:48] Speaker 03:
You have to explain why you believe him.

[00:09:50] Speaker 03:
They didn't find that Mangonaro and Brecker were incredible in the sense of liars.

[00:09:56] Speaker 03:
They didn't say, we find them to be dishonest.

[00:09:59] Speaker 03:
They just chose one opinion over the other for reasons that remain unknown to this day.

[00:10:04] Speaker 03:
If I can shift gears to the issue of secondary considerations, unlike most cases, it is undisputed in this case that the invention contributed to the success of the product and was directly praised as being an innovation.

[00:10:19] Speaker 03:
And this is from A5832, just an example.

[00:10:23] Speaker 03:
A doctor said the Sapient 3 valve is, quote, a very clear advance on previous designs, which incorporates the skirt.

[00:10:32] Speaker 03:
a very clear advance.

[00:10:33] Speaker 03:
This is real-time, real-world descriptions of industry praise.

[00:10:39] Speaker 03:
Their own expert, Mr. Woods, said, and this is at A7199, that the success of the Sapien III is due in part to the skirt, the invention.

[00:10:52] Speaker 03:
Well, why doesn't the board take that seriously?

[00:10:55] Speaker 03:
All they say is, well, there are other features.

[00:10:58] Speaker 03:
There are other things that were cool in the Sapien 3-2.

[00:11:01] Speaker 03:
Maybe there were, but that's not the question for this court.

[00:11:04] Speaker 03:
If Apple introduces a new device that has three different very neat features in it, one of which infringes, their answer is, you don't have to think about secondary considerations as to feature one, because features two and three are also cool.

[00:11:18] Speaker 03:
That's not the law.

[00:11:19] Speaker 03:
But it's a long-felt but unsolved need, and that's their argument.

[00:11:24] Speaker 03:
And the evidence is replete that it was long-felt and unresolved.

[00:11:29] Speaker 03:
In 2003, 2004, at the very beginning of this process, there had only been two or three implants.

[00:11:36] Speaker 03:
People realized that paravalvular leakage was a problem.

[00:11:39] Speaker 03:
You're into your battle, just so you know.

[00:11:41] Speaker 03:
It was not solved until the skirt was put into devices in the 2012-13 window.

[00:11:49] Speaker 01:
Why isn't the right span of time the span from the 2003 recognition of a problem and your invention, which is not long?

[00:12:03] Speaker 03:
Absolutely not, but your honor, unless people actually bring it into the real world and see that it works, I mean the skepticism of this product remains.

[00:12:11] Speaker 03:
The patent sat there for four years while my client worked on bringing a prototype to market, and it wasn't until the prototype was seen in 2008 that people took it seriously.

[00:12:22] Speaker 03:
and in fact was copied by the petitioner who then put it in their next generation valve and in Europe in 2009, 2010 it worked like gangbusters.

[00:12:31] Speaker 03:
They went through the FDA process.

[00:12:33] Speaker 03:
It can't be that that period of time stops when the patent issues.

[00:12:36] Speaker 03:
What if no one reads the patent or more likely, as in this case, what if people think it won't work until they actually try it?

[00:12:42] Speaker 03:
And so the relevant period for long felt need is when is the need identified and when is it actually in the real world, not necessarily a commercial product, but in clinical trials or whatever the case may be, when is it tested and determined it worked.

[00:12:54] Speaker 03:
And with that, Your Honor, I reserve the rest of my time for rebuttal.

[00:12:57] Speaker 03:
Thank you.

[00:13:05] Speaker 02:
Let's hear from the government.

[00:13:07] Speaker 04:
Good morning, Your Honors, and may it please the court.

[00:13:10] Speaker 04:
Here, the board's decision is supported by substantial evidence.

[00:13:14] Speaker 04:
First, I would like to address the point that was made about whether or not Boston Scientific waged its claim construction argument, the only time that Boston Scientific raised that issue with respect to the attachment of the commissars to that.

[00:13:27] Speaker 02:
Well, let me take you to where I think I am an issue.

[00:13:31] Speaker 02:
And that's on page 50 of the blue brief where Boston Scientific says the PTAB aired when it credited Dr. Bowler's testimony above the testimony of their experts, because in contrast to their expert, he has no relevant experience with transcatheter aortic valve replacement, surgical valve replacement, or abdominal aortic endocrine.

[00:13:54] Speaker 02:
There's a clear logic.

[00:13:56] Speaker 02:
So, why shouldn't we listen to it?

[00:13:59] Speaker 04:
Sure.

[00:13:59] Speaker 04:
Here what the board found was that Dr. Buller did have experience with implanting stent type prosthetic devices.

[00:14:07] Speaker 04:
And also at the time of the invention in 2004, there had only been a handful of these types of

[00:14:13] Speaker 04:
prosthetic heart valve replacements done, only a handful.

[00:14:17] Speaker 04:
And Dr. Brecker, BASMA's scientific expert, also admitted as such that only a handful of these had been done.

[00:14:24] Speaker 04:
And so therefore, one of skill in the art at the time of the invention in 2004 could have been a cardiologist that had a working knowledge of at least implanting these types of stent prosthetic devices.

[00:14:35] Speaker 04:
And Dr. Buller met this definition.

[00:14:38] Speaker 04:
Further, Dr. Buller's testimony that was presented before the board was supported by the evidence of record.

[00:14:44] Speaker 04:
And that was shown in what Dr. Buller relied on with respect to what was taught in the stent graft art.

[00:14:51] Speaker 04:
In particular, the Elliott reference teaches that fabric seals can be used to prevent leakage between prosthetics and native tissue.

[00:14:59] Speaker 04:
and further that these fabric seals can be used in calcified and irregular environments.

[00:15:05] Speaker 04:
Therefore, not only was Dr. Buller's testimony supported by the record, but the board also found here that there was a reasonable expectation of success, which was the second argument that was raised.

[00:15:16] Speaker 01:
What would you say about Mr. Wolf's point that not all calcifications are equal?

[00:15:20] Speaker 04:
So Dr. Manganaro made that argument as well as Dr. Brecker.

[00:15:25] Speaker 04:
But what the board found is that they made those arguments with no supporting evidence.

[00:15:31] Speaker 04:
So they made that argument based on their experience.

[00:15:34] Speaker 04:
But again, remember, as of 2004, not that many people had actually implanted these devices in these environments.

[00:15:42] Speaker 04:
And so this experience is probably, or rather, their testimony is riddled with hindsight because it's based on an experience

[00:15:48] Speaker 04:
that happened post 2004.

[00:15:50] Speaker 04:
Also, they didn't actually cite to any supporting evidence with respect.

[00:15:55] Speaker 01:
Just forgive me.

[00:15:55] Speaker 01:
Is what you just said responsive to what I thought I heard Mr. Wolf say, which is that everybody who knows anatomy knows that calcification in the region of the body that Elliott was focusing on would be different from calcification in the heart area that this invention.

[00:16:16] Speaker 01:
is focused on, and that, Boston Scientific's experts said, a flap in one truly cannot be counted on to do the same work as a flap in the other.

[00:16:32] Speaker 04:
Well, again, a reasonable expectation of success does not require absolute predictability.

[00:16:37] Speaker 01:
It requires reasonable predictability.

[00:16:40] Speaker 01:
Somewhere between here and here, and nobody has any idea where you're going.

[00:16:45] Speaker 04:
Well, again, Dr. Brecker did testify that even in calcified heart valve environments, the gaps could be very small.

[00:16:52] Speaker 04:
And so because the Elliott reference does teach that these flaps would prevent leakage between prosthetics and native tissue, even when there is irregular topography and calcification, it would have been reasonable for a person of ordinary skill in the art

[00:17:09] Speaker 04:
to understand that those flaps would work in these types of devices, even in this environment.

[00:17:14] Speaker 04:
And so therefore, the board's findings are supported by substantial evidence.

[00:17:20] Speaker 04:
Finally, with respect to the secondary indicia of non-obviousness, the board did credit Boston Scientific's arguments with respect to industry praise and commercial success.

[00:17:31] Speaker 04:
But what the board found is that this was a predictable area of art.

[00:17:36] Speaker 04:
not only was the problem known, the risk of PVL, which Boston Scientific admits, but there were solutions that were known as well.

[00:17:44] Speaker 04:
And so the fact that Boston, sorry, that those at the time

[00:17:52] Speaker 04:
used other types of solutions to address PBL, goes against the record evidence here that there was some sort of secondary addition of non-obviousness.

[00:18:01] Speaker 04:
So even though they did show some modicum evidence of non-obviousness, the overwhelming evidence in the record shows that these types of devices would have been obvious at the time of the event.

[00:18:13] Speaker 01:
I'm sorry, what is the overwhelming evidence if it kind of comes down to

[00:18:19] Speaker 01:
what a skilled artisan would have understood about some probability, whatever it is, of success of moving this skirt flap device from one area of the body to another where it had never been done before.

[00:18:39] Speaker 01:
That's really, I mean, maybe it's sufficient, but overwhelming if there's serious secondary considerations saying,

[00:18:49] Speaker 01:
industry praise in particular.

[00:18:52] Speaker 01:
It says, this is actually terrific.

[00:18:55] Speaker 01:
Why do you say that if it's just the morning's work and anybody could have done it?

[00:19:00] Speaker 04:
Sure, there was evidence of industry praise, but what the board also found was that Boston Scientific had not shown that there was failure of others.

[00:19:08] Speaker 04:
that there was unexpected results here.

[00:19:11] Speaker 04:
And because of that, because the problem of PVL was known and because solutions to address PVL were known, they simply did not meet their burden to show that there were this overwhelming evidence of non-obviousness.

[00:19:24] Speaker 04:
What the record actually shows is that those of skilled the art knew that there was a problem to be solved and knew of ways to solve the problem.

[00:19:32] Speaker 01:
I'm sorry, let me just interrupt.

[00:19:34] Speaker 01:
Now I think you just used overwhelming evidence in something like the mirror image way.

[00:19:40] Speaker 01:
Have we ever said that secondary considerations have to be overwhelming?

[00:19:45] Speaker 01:
No.

[00:19:46] Speaker 01:
Except it sounds very technical.

[00:19:47] Speaker 01:
It must outweigh and therefore overwhelm evidence from the art.

[00:19:51] Speaker 01:
That's not what you could have meant.

[00:19:53] Speaker 04:
Sorry, I apologize.

[00:19:54] Speaker 04:
I misspoke.

[00:19:54] Speaker 04:
What I wanted to articulate was that here it did not outweigh the evidence of obviousness.

[00:20:01] Speaker 04:
And that is because there is evidence in the records showing that the fabric seals used in Elliot and Thornton were successful in preventing leaks.

[00:20:13] Speaker 04:
And therefore, it would have been reasonable for one of ordinary skill in the art to understand that these types of seals would also work in a prosthetic device as disclosed in Spencer.

[00:20:23] Speaker 00:
Would you agree that if there is industry praise, say for example, significant industry praise about the patented feature, about the patented advance, then that should be given credit and that industry praise is not undermined if there's industry praise about additional features of some commercial embodiment.

[00:20:47] Speaker 00:
Would you agree with that?

[00:20:50] Speaker 00:
So if there's industry praise about elements one, two, and three, the patented feature is really solely about element one.

[00:20:58] Speaker 00:
The praise directed towards element one isn't undercut in any way by additional praise for elements two and three.

[00:21:08] Speaker 00:
Would you agree with that?

[00:21:09] Speaker 04:
I wouldn't agree with that.

[00:21:10] Speaker 04:
If elements two and three were also shown to have significant

[00:21:16] Speaker 04:
adoration by the industry that the public found that those features of the device, of a multi-component device, were also given a lot of praise.

[00:21:26] Speaker 04:
And I think that would undercut any industry praise shown for one particular feature of a multi-component device.

[00:21:32] Speaker 00:
And why?

[00:21:33] Speaker 00:
I mean, let's say, hypothetically, I have the opposite instinct.

[00:21:39] Speaker 00:
Can you explain to me why your position makes more sense?

[00:21:47] Speaker 04:
So I think that would make more sense only because these other features could also be the subject of great inventive output.

[00:21:58] Speaker 04:
There could also be patents on those other features.

[00:22:01] Speaker 04:
And if there are, then there would also be a recognition that those other features are also inventive.

[00:22:08] Speaker 04:
The fact that the industry praise is praising other features of the device, it undercuts the fact that one of skill and the art wouldn't have gone to one of those other features of the device in order to commercialize it.

[00:22:28] Speaker 02:
I should think that your best argument is that the industry praise might be because it's Boston scientific.

[00:22:37] Speaker 02:
And as a consequence, people pay attention when Boston Scientific puts something on the market.

[00:22:44] Speaker 02:
And while there may have been equally useful devices, nobody ever noticed.

[00:22:51] Speaker 02:
But I don't know if there's anything in the record that indicates that.

[00:22:54] Speaker 04:
Right.

[00:22:54] Speaker 04:
Well, also, Boston Scientific here is pointing to the petitioner's products for showing industry praise and commercial success.

[00:23:00] Speaker 01:
Edwards is a pretty substantial company.

[00:23:02] Speaker 04:
Yes, Edwards is a pretty substantial company.

[00:23:04] Speaker 04:
And Edwards' prior devices also had significant praise and commercial success.

[00:23:10] Speaker 04:
So with respect to the commercial success evidence, it's also unclear whether or not Edwards Market Share had something to do with the fact that their second generation device

[00:23:19] Speaker 04:
also had such commercial success.

[00:23:22] Speaker 01:
Can I ask you, as a doctrinal matter, am I right in thinking that the task of deciding what to do with the mix of considerations, secondary on the one hand, sorry about that, and the prior art stuff on the other is a law task for us, it's not a fact task for the board?

[00:23:45] Speaker 04:
That is a good question.

[00:23:47] Speaker 04:
In Inland Steel, for example, the court looked at the board's consideration of unexpected results in comparison with the board's consideration of what the prior art showed.

[00:23:59] Speaker 04:
And the court indicated that the board's weighing of those considerations were given deference.

[00:24:05] Speaker 01:
Right, but we don't have an unexpected results is a little bit

[00:24:10] Speaker 01:
straddles the same topic as reasonable expectation of success, I think, or something awfully close.

[00:24:15] Speaker 01:
But industry preys, which is kind of the interesting one here.

[00:24:19] Speaker 04:
Right.

[00:24:19] Speaker 04:
So I agree that the overall conclusion with respect to obviousness is a question of law.

[00:24:27] Speaker 04:
And therefore, the ultimate weighing of whether or not a certain

[00:24:33] Speaker 04:
elements showed obviousness or non-obvious is one of law.

[00:24:37] Speaker 04:
But the court does give deference to the board's individual weighing of each consideration that the court considers because each of those considerations are questions of fact.

[00:24:49] Speaker 04:
So I think that's the best answer I can give you.

[00:24:54] Speaker 00:
Last question for me is, I know we can find statements in our case law which say that when it comes to judging the time frame for long felt need, failure of others, the cutoff point will be at the time of the invention.

[00:25:13] Speaker 00:
I'm wondering, is that the right way to think about it?

[00:25:17] Speaker 00:
The other side makes a point and rests on a kind of logic that says, well, if the industry, even after the filing of

[00:25:31] Speaker 00:
their patent application is still struggling to solve a problem and then they continue to struggle, then why shouldn't that also be taken into account even though that time of struggle is occurring after the filing date of their patent application?

[00:25:48] Speaker 04:
So I think that could also depend on what industry we're talking about.

[00:25:53] Speaker 04:
Here we're talking about an industry where the products have to be approved by a regulatory agency.

[00:25:59] Speaker 04:
So even though, first, backing up to the 2004 date, the 2004 date is their priority date, but it's not their filing date.

[00:26:07] Speaker 04:
They filed it later.

[00:26:08] Speaker 04:
So that disclosure that they're relying on of their application wasn't public until later.

[00:26:15] Speaker 04:
Second,

[00:26:16] Speaker 04:
the products that are at issue here have to be approved by the FDA.

[00:26:21] Speaker 04:
So even though there was time that elapsed between the 2004 date and when one of the Sapien devices was on the market, there was a period of time where that Sapien device was developed and then went through approval.

[00:26:36] Speaker 04:
So it's hard to just, it's hard to basically figure out how much time is necessary in these types of cases.

[00:26:43] Speaker 04:
I think here,

[00:26:45] Speaker 04:
It's clear that PVL was known, and it's clear that there were solutions that were being addressed for PVL much earlier than the date that they say that they were.

[00:26:56] Speaker 04:
So I don't think that their evidence here provides a coherent argument for a long-held need.

[00:27:06] Speaker 04:
If there are no further questions, we ask that the court affirm the decision.

[00:27:11] Speaker 03:
Thank you, Your Honor.

[00:27:13] Speaker 03:
Just a few points I'd make.

[00:27:15] Speaker 03:
First, to your questions sort of going, does the size of the company perhaps dictate the industry praise?

[00:27:21] Speaker 03:
I would just ask the court to look at the blue brief at 34 to 36 and the gray at 25 to 27.

[00:27:26] Speaker 03:
Well, it's just a red herring.

[00:27:29] Speaker 03:
Very good, Your Honor.

[00:27:30] Speaker 03:
Let's go on to the issue of failure of others.

[00:27:34] Speaker 03:
In 2005 to 2007, and we have this in our brief, but let me just give you an example.

[00:27:38] Speaker 03:
At A6098, Edwards itself said of its Sapien XT, quote, no PVL reduction solution.

[00:27:45] Speaker 03:
They were characterizing their own work.

[00:27:47] Speaker 03:
And so this notion that because the first generation had reduced PVL from X to 30 doesn't mean that the industry wasn't struggling and failing to reduce it from 30 to 2 where it sits today, thanks to my client's invention.

[00:28:03] Speaker 01:
On the assumption that perhaps less weight was given in the overall obvious legal conclusion to secondary considerations than should have been, our task is to try to assess the strength of the primary consideration evidence.

[00:28:22] Speaker 01:
What's the core thing that you think is missing from that side?

[00:28:28] Speaker 03:
The core thing that's missing is

[00:28:31] Speaker 01:
If I understand your question correctly, Ron, or is... Is this the reasonable expectation of success of going from down here to up here?

[00:28:39] Speaker 03:
from going from a relatively healthy, and just to be clear for Elliott, remember this was the point that my learned counsel quoted on, Elliott itself says it should be placed in healthy portions of the aorta.

[00:28:50] Speaker 03:
That's at A1710.

[00:28:52] Speaker 03:
So it's not about distance as the final written decision.

[00:28:55] Speaker 03:
It's about the fundamentally different both original anatomy, where you're pushing valves backwards, that's clear, and also then the disease of that initial anatomy has very different

[00:29:05] Speaker 03:
fundamentally different characteristics.

[00:29:07] Speaker 03:
And it was a breakthrough to realize you could use a skirt to fill with blood, to clot, to seal, to lock, and to prevent paravalvular leakage around the outside.

[00:29:19] Speaker 03:
That was a breakthrough.

[00:29:20] Speaker 03:
None of that's discussed in Elliott, Thornton, or Cook in any context, let alone in the unique and very challenging anatomy of the human heart.

[00:29:32] Speaker 03:
The last point I would make is one of the most frustrating things about reading the final written decision, and it was repeated today, which is that Manganiro and Brecker, our experts, were conclusory in their statements of that anatomy.

[00:29:55] Speaker 03:
These guys are the expert.

[00:29:57] Speaker 03:
These guys are the ones that lived it, that breathed it, that defined it, that wrote the textbook.

[00:30:02] Speaker 03:
So to say that there are opinions that are conclusory are like, to use the analogy, saying Bill Gates is conclusory when he talks about the history of the operating system, or Roy Williams is conclusory when he talks about the development of half-court offense.

[00:30:13] Speaker 03:
These are the guys that know it.

[00:30:15] Speaker 03:
These are the guys that lived it.

[00:30:18] Speaker 03:
What else do you want?

[00:30:19] Speaker 03:
And to dismiss it by saying its conclusory is just refusing to address the issue at hand, which is that this was a breakthrough that has saved lives.

[00:30:26] Speaker 03:
Thank you very much.