[00:00:00] Speaker 05:
We will hear argument next in number 222230, Cardio Valve Against Edwards Life Sciences.

[00:00:09] Speaker 01:
Good morning, Your Honors.

[00:00:10] Speaker 01:
May it please the court, my name is Sarah Horton.

[00:00:12] Speaker 01:
I am representing Appellants Today Cardio Valve.

[00:00:15] Speaker 01:
I'd like to reserve three minutes of time for rebuttal.

[00:00:19] Speaker 01:
The board canceled claims of CardioValve's 341 patent by misapplying the legal standards related to obviousness, and by specifically employing obvious-to-try legal framework in a situation where the missing limitation of the 341 patent is found nowhere in the prior art.

[00:00:34] Speaker 01:
An invention is not obvious-to-try where only vague prior art guides an inventor towards a particular solution.

[00:00:41] Speaker 01:
Obvious-to-try is not employable where the prior art only gave general guidance, and that is the situation we have here.

[00:00:47] Speaker 01:
The issue, the missing limitation, is whether to couple a leaflet.

[00:00:53] Speaker 05:
So when you talk about a solution in the prior art, sometimes we talk about prior art as documents, and sometimes we talk about it as the body of knowledge, whether written down or in the heads of the relevant artisan, is available for that group.

[00:01:15] Speaker 05:
of people to use.

[00:01:18] Speaker 05:
Why would one think that taking the Supreme Court's paragraph on obvious is to try, as the frame is, I think, is what did, that one would have to find these known solutions in something other than the heads of the skilled artists?

[00:01:40] Speaker 01:
So I think the KSR quote- You have other arguments, but you began with this one.

[00:01:44] Speaker 01:
I did, yes.

[00:01:45] Speaker 01:
And I think this is the most important one, because this is the legal framework by which the claims are canceled.

[00:01:50] Speaker 01:
And I think that's the de novo review standard, which we're most interested in talking about in any event.

[00:01:54] Speaker 01:
But the KSR paragraph about a finite number of identified predictable results, I think, is really where this draws from.

[00:02:00] Speaker 01:
the identified, I think, refers to in the prior art.

[00:02:04] Speaker 01:
An obvious-to-try framework is difficult to apply where that is not the case, otherwise we... Can I just interrupt for a second?

[00:02:11] Speaker 03:
I think what you're saying is that the finite solutions actually have to be expressly spelled out in the reference, right?

[00:02:18] Speaker 03:
Correct, yes.

[00:02:18] Speaker 03:
And so if they're not expressly spelled out, then that's violative of the obvious-to-try

[00:02:23] Speaker 01:
I think that's correct, especially in the obvious-to-try world, you have a bigger problem with hindsight bias.

[00:02:31] Speaker 01:
And if the element is not known in the prior art and can simply be substituted by post-hoc, obvious opinions of an expert and nothing else that's actually in the prior art contemporaneously, then the bias towards hindsight becomes more pervasive.

[00:02:49] Speaker 03:
Why isn't that kind of a bright line rule?

[00:02:52] Speaker 03:
advocating for there.

[00:02:54] Speaker 03:
I mean, you're saying, you know, whenever there's obvious to try, it has to expressly be in the part of art, not just something that a person of ordinary skill in the art would understand given, you know, the suggestion in this case that the item be left behind.

[00:03:12] Speaker 03:
And then the question is whether a person of ordinary skill in the art would know that there's only a few ways that something could be left behind.

[00:03:20] Speaker 01:
Sure, I think that's part of it, but I think it's also here where the missing limitation is actually a structural element, and that's found nowhere.

[00:03:28] Speaker 01:
There are no cases that we've seen cited by the board or by Edwards where the missing structural limitation is not in the prior art and obvious to try is found and upheld by this court.

[00:03:42] Speaker 01:
So I think that's where we see the deficiency here.

[00:03:46] Speaker 04:
But the missing structural element, I mean, maybe it already was in Goldfarb and not

[00:03:50] Speaker 04:
there was already some kind of connecting mechanism that would connect gold parts flat to the catheter.

[00:03:58] Speaker 04:
And then your expert Dr. Sachs said, well that would be super conventional to make that coupling.

[00:04:04] Speaker 04:
Use any one of a number of well understood conventional mechanisms, including sliding mechanisms, hinges, pins, etc, etc.

[00:04:15] Speaker 04:
There really were already many, many off the shelf types of coupling mechanisms that could be used to couple this slab to something.

[00:04:27] Speaker 04:
And, you know, there were, as I understand it, basically two different somethings.

[00:04:33] Speaker 04:
One was to the patient himself, somehow, some heart tissue.

[00:04:37] Speaker 04:
And then secondly, to the actual device itself, which

[00:04:42] Speaker 04:
you know, for a period of time, it was right there with the catheter.

[00:04:45] Speaker 04:
And so why not just connect now the flaps to something that was previously right next to, right inside of the catheter, i.e.

[00:04:57] Speaker 04:
the fixation glass.

[00:04:58] Speaker 01:
So your honor, I think to the Dr. Sacks testimony point, I think what he was talking about there was how you would couple it mechanically to actually, I think, element 86, which is actually the catheter.

[00:05:08] Speaker 01:
So those well-known ways of coupling mechanically, we don't dispute that there are well-known ways.

[00:05:12] Speaker 04:
But you know, KSR is requiring a little bit of reasoning there and context.

[00:05:17] Speaker 04:
We aren't just slotting everything into completely separate cells and then never to look at them again when we're

[00:05:27] Speaker 04:
inside of a different cell.

[00:05:28] Speaker 04:
Instead, we're trying to look at things a little more contextually and fluidly.

[00:05:33] Speaker 04:
And in this particular instance, we know that there's well-established ways to connect the flaps to the catheter.

[00:05:42] Speaker 04:
That's what Goldfarb says.

[00:05:44] Speaker 04:
That's what Dr. Sacks says.

[00:05:46] Speaker 04:
Why would there be some reason that you couldn't likewise use those very conventional mechanisms, coupling mechanisms, to connect the flaps to

[00:05:56] Speaker 04:
the fixation device to the clips.

[00:05:58] Speaker 01:
I think it's a matter of how you get there.

[00:06:00] Speaker 01:
What we have in the prior art is this statement that, in Goldfarb itself, that the flaps could be left behind.

[00:06:10] Speaker 01:
And that's all we have.

[00:06:11] Speaker 01:
That's our starting point.

[00:06:12] Speaker 04:
Right.

[00:06:12] Speaker 04:
And we also know that we wouldn't just leave them behind unconnected.

[00:06:17] Speaker 01:
Correct.

[00:06:17] Speaker 01:
I think everyone agrees that that would be bad.

[00:06:19] Speaker 04:
Now we know it's got to be connected to something.

[00:06:22] Speaker 01:
Correct.

[00:06:22] Speaker 04:
And then... And when you look at the pictures,

[00:06:25] Speaker 04:
the catheter and the clips are right next to each other.

[00:06:29] Speaker 04:
You could very easily fasten the flaps to something in the clips that is just about as close of an interchangeable substitute as you could get to the original coupling to the catheter.

[00:06:46] Speaker 01:
Your Honor, I think we would respectfully disagree.

[00:06:47] Speaker 01:
That's the piece that is missing from the prior art.

[00:06:50] Speaker 01:
If that was so obvious, one would think that it would have been disclosed somewhere in the prior art.

[00:06:54] Speaker 04:
That's a 102, right, but here we're trying to use a little bit of extra level reasoning here, not just plain old 102.

[00:07:03] Speaker 01:
So, like the court in Grunenthal and Inray cycle, Benza, Prine, and Leo Pharma, the court has found that obvious to try framework isn't applicable where there's a missing limitation.

[00:07:14] Speaker 01:
And specifically in the Grunenthal case, there, obvious to try was not applicable in this course.

[00:07:20] Speaker 04:
That was very unpredictable art about trying to find a polymorph.

[00:07:25] Speaker 04:
Here, we're dealing with, I don't know, a different context.

[00:07:28] Speaker 04:
This is all mechanical and

[00:07:30] Speaker 04:
And again, dealing with prior coupling mechanisms that are already well known.

[00:07:37] Speaker 01:
So Your Honor, I think that in the Grunenthal, which I agree is a different art, but here we are talking about placing a mechanism in a human's beating heart.

[00:07:46] Speaker 01:
So it's not just mechanical switch this out for that out.

[00:07:49] Speaker 01:
There are other considerations about how and why one of ordinary skill in the art might try to do that in that scenario.

[00:07:55] Speaker 01:
But even in Grunenthal, there the limitation required a polymorph A, right?

[00:08:00] Speaker 01:
then what was known was polymorph B and that polymorph studies and screening could be done.

[00:08:05] Speaker 01:
And even in that situation where those two things were known, the obvious to try framework was not available for the challenger of the patent there.

[00:08:13] Speaker 04:
Because that particular art is really unpredictable.

[00:08:16] Speaker 04:
You have no idea whether other crystalline form structures even exist at all.

[00:08:21] Speaker 04:
And so you're kind of out to sea in the laboratory of trying to

[00:08:26] Speaker 04:
piece things together to see if you can luckily cook up a new crystalline form.

[00:08:31] Speaker 04:
I mean, we're in a different world here with this mechanism.

[00:08:35] Speaker 01:
So in Rolls Royce as well, that was turbines for jet engines.

[00:08:39] Speaker 05:
Can you talk about the factual specifics here, which is, I guess, what has troubled me.

[00:08:46] Speaker 05:
It feels very odd to me to talk about

[00:08:50] Speaker 05:
just two possibilities, the device or the human body for the connector.

[00:08:56] Speaker 05:
And I'm trying to imagine and failing to read anything that tells me what I should be imagining about the variables, the different kinds of tissue that you could connect these flaps to.

[00:09:08] Speaker 05:
You could connect them maybe at one point or maybe two points, and I'm wondering if

[00:09:11] Speaker 05:
It's not at two points are they going to be flapping around inside the atrium even though they won't be pulled down into the ventricle.

[00:09:20] Speaker 05:
Same thing with the different components of this device and the different connectors.

[00:09:26] Speaker 05:
Obviously, nobody's talking about rigidly connecting this thing

[00:09:31] Speaker 05:
the actual thing without an intervening connector to anything in the clip.

[00:09:36] Speaker 05:
At least nobody's explained how that would enable the top, the proximal 18 to go into the annulus and clip to the 16 and how that would even be done because you need to put post 12 down south before you pull it back up.

[00:09:56] Speaker 05:
And so it seems to me that

[00:09:59] Speaker 05:
I don't know.

[00:10:00] Speaker 05:
To me, coming into the argument, the more worrisome for the other side piece of your argument was that this does not seem like a simple, small number of possibilities where the concrete how has been identified by the board that would actually produce

[00:10:25] Speaker 05:
what has to be a relevant form of success, namely that this thing could be safely left in the atrium without a problem.

[00:10:36] Speaker 05:
And that doesn't seem to me to have anything at all to do with the source of the information about the solutions.

[00:10:47] Speaker 01:
So I think that the concrete how, as your honor put it, is a good way to put it.

[00:10:51] Speaker 01:
And I think this is where we come to the hindsight issue, which has been bothersome to cardio valve as well.

[00:10:57] Speaker 01:
To get to the concrete how of the claims, you have to take a path that goes right back to the claims.

[00:11:04] Speaker 01:
And it's like you're looking for that claim to couple.

[00:11:06] Speaker 01:
And what you have to do is not just where the locations are.

[00:11:09] Speaker 01:
There are potentially, yes, broadly two locations to the heart tissue itself.

[00:11:16] Speaker 01:
or to the fixation device somewhere.

[00:11:19] Speaker 01:
These things are complicated mechanisms.

[00:11:21] Speaker 05:
And differences among them on the tissue side are apparently quite significant.

[00:11:27] Speaker 05:
It seems odd to view that as a single category, since the various experts seem to have different views about whether one would even be possible versus the other.

[00:11:38] Speaker 05:
I'm not sure why it's also appropriate or why

[00:11:43] Speaker 05:
be any less inappropriate to view the device as a single thing for coupling, not only because there are different locations on it, but because there are different couplers, strings, or rigid washers.

[00:11:59] Speaker 05:
And I don't understand from anything that I've read, and maybe I've missed it, of how those things end up leaving these quasi-rigid flaps in a

[00:12:13] Speaker 05:
form that is safe.

[00:12:18] Speaker 05:
There must be a kind of rigidity to this, otherwise they could just flap it around in the atrium.

[00:12:24] Speaker 05:
They might not go down into the ventricle, but the flapping around in the atrium, that

[00:12:30] Speaker 01:
I don't know if that seems worried.

[00:12:45] Speaker 01:
that come around the leaflets while the flaps 109 are doing their job.

[00:12:50] Speaker 01:
If you change that mechanism to couple something else to those flaps, then you've changed how it is supposed to work.

[00:12:56] Speaker 01:
So I think that is hard to envision one of ordinary skill in the art thinking, oh, I have two broad locations, I guess,

[00:13:05] Speaker 01:
or where I could couple these things from that one statement in Goal Farm Free 2.9 that says you could leave the flaps behind, but then it doesn't tell you where to put them, what to do with them.

[00:13:13] Speaker 01:
It's not illustrated.

[00:13:14] Speaker 01:
It's not discussed more in an embodiment.

[00:13:17] Speaker 01:
And then you have multiple choices.

[00:13:19] Speaker 01:
Are you going to couple to the heart tissue and within the heart tissue?

[00:13:22] Speaker 01:
Is it the valvanulis?

[00:13:23] Speaker 01:
Is it the wall?

[00:13:26] Speaker 04:
Dr. Sacks said it's not the valvanulis.

[00:13:28] Speaker 04:
It has to be the wall.

[00:13:29] Speaker 01:
And there is prior art that shows that it is to the wall, and that's the Zapori reference that is in the record.

[00:13:37] Speaker 04:
And then there are three other contemporaneous art references.

[00:13:44] Speaker 01:
I think that the presumptively enabled prior art that is of record, which is the only evidence to Your Honor's question about what type of evidence, the contemporaneous prior art is that it could be to the wall or to the valvanula.

[00:14:00] Speaker 04:
Then Dr. Sackers shut that down.

[00:14:02] Speaker 03:
In the prior art, what is the ick?

[00:14:04] Speaker 03:
It was something else in the prior art, right?

[00:14:07] Speaker 03:
I'm sorry, Your Honor.

[00:14:08] Speaker 03:
It's a different mechanical structure?

[00:14:10] Speaker 01:
It's the prior arc when you're talking about the leaflet stabilizers, which is what tamps down the leaflets, which is broadly what 109 is in the Goldfarb 329.

[00:14:19] Speaker 01:
So if you're looking to talk about how to leave behind leafless stabilizers, sorry, Your Honor, I might have that wrong.

[00:14:31] Speaker 01:
104.

[00:14:35] Speaker 01:
The leaflet stabilizers, when you look to the contemporaneous art about how to leave behind leaflet stabilizers, it is to couple them either to the annulus or to the valve wall.

[00:14:44] Speaker 01:
That's what's in the prior art.

[00:14:46] Speaker 01:
publications that are around at the time.

[00:14:48] Speaker 01:
The only person saying that the leaflets can be coupled to, sorry, the flaps can be coupled to the clips as required by the cardiovalve patent is the conclusory testimony of Dr. Bessley, and we don't think that's enough to sustain honest substantial evidence.

[00:15:07] Speaker 04:
Can you just explain why it would be so strange to couple the flats to coupling number 19 instead of catheter 86 when coupling number 19 looks like it's right there?

[00:15:20] Speaker 04:
next to the catheter 86?

[00:15:22] Speaker 01:
Sure, it is right there, your honor, but that's respectfully not how one of ordinary skill in the art would think about it.

[00:15:29] Speaker 01:
The coupling number is used to come down with catheter 86 and then it stays.

[00:15:36] Speaker 01:
In order to make it work, you have to push it down.

[00:15:43] Speaker 01:
The flaps have to stay.

[00:15:48] Speaker 01:
You're pushing the entire mechanism down and if you were to couple to the coupling member, then you would have the situation where the flaps are up here, the leaflets are here, and the clips are trying to

[00:16:08] Speaker 01:
get the leaflet, but the flaps, which are supposed to be stabilizing the leaflet, don't even do anything to keep the leaflet from flailing.

[00:16:19] Speaker 03:
What do you think is the best record evidence to support what you just said?

[00:16:23] Speaker 03:
I mean, because, you know, this seems to be a case where we've got competing expert testimony, and we're supposed to chum in, you know, whether there's substantial evidence.

[00:16:31] Speaker 03:
So what is your best evidence to show that, like, this Dr. Vesely's testimony can't be

[00:16:38] Speaker 03:
is not substantial evidence to support the board's finding.

[00:16:41] Speaker 01:
Well, I think the issue is really the legal issue there is that conclusory expert testimony just can't be enough according to the case law, especially... What if I don't think it's conclusory?

[00:16:53] Speaker 03:
Excuse me?

[00:16:53] Speaker 03:
What if I don't think it's conclusory?

[00:16:56] Speaker 01:
Well, there are no cases that talk about... There are no cases that have been cited where expert testimony could overcome a missing limitation in an obviousness analysis.

[00:17:06] Speaker 03:
OK, let me ask you another question.

[00:17:07] Speaker 03:
So my question was, what evidence do you have to support how this is so unpredictable, not a predictable solution, not a finite number of solutions?

[00:17:18] Speaker 03:
Is that your expert you're relying on?

[00:17:21] Speaker 01:
Well, I think, Your Honor, we're not asking the court to reweigh the expert testimony.

[00:17:25] Speaker 01:
I think what is most important here is that the contemporaneous art, what was in the art and known in the art, that's Lisca, St.

[00:17:31] Speaker 01:
Gore, Powell, Zippory, that was in the same field by the same groups of inventors, lots of it, as Goldfarb, has to hold more weight than the say-so of a post-hoc expert.

[00:17:44] Speaker 01:
Thank you, Your Honor.

[00:17:59] Speaker 00:
Thank you, Your Honor, and may it please the Court, Josh Soloff, Kenobi Martins, on behalf of the Appellee Edwards Life Sciences.

[00:18:05] Speaker 00:
The dispute here was narrow.

[00:18:07] Speaker 00:
It related to a single limitation in the patent claim, whether Goldfarb 329 disclosed at least one lip, at least a lip coupled to the annular portion, or whether it rendered that obvious.

[00:18:18] Speaker 05:
Just a very trivial thing.

[00:18:21] Speaker 05:
In the 104 pair

[00:18:23] Speaker 05:
Is there one annular portion, or are there two annular portions?

[00:18:27] Speaker 00:
There are two annular portions, and it wasn't in dispute that both of those are annular portions within the scope and the length.

[00:18:35] Speaker 00:
The only dispute was whether a person of skill in the art would have found it obvious to couple the annular portions to the clip.

[00:18:42] Speaker 00:
And it's been alleged that the board relied exclusively on expert testimony resolving this, and that's not the case.

[00:18:49] Speaker 00:
The board started with the words of Goldfarb 329,

[00:18:52] Speaker 00:
As we've already discussed today, Goldfarb 329 expressly states that the flaps may be left behind to assist in holding the leaflets.

[00:19:02] Speaker 00:
And so the board then analyzed the evidence that was of record to determine what does that mean?

[00:19:07] Speaker 00:
How would a person of ordinary skill in the art have interpreted may be left behind?

[00:19:11] Speaker 05:
Why do you think the board ended up relying on this obviousness to try portioning

[00:19:27] Speaker 05:
don't think you quite have a sufficiently backed up narrative of motivation to do this particular thing with a reasonable expectation of success.

[00:19:39] Speaker 00:
Yeah, I think that the board thought that obvious to try sufficiently describe the evidence that had been produced.

[00:19:45] Speaker 00:
And quite frankly, the board was bending over backwards to give some credit to the testimony of cardio vows expert Dr. Sacks.

[00:19:53] Speaker 00:
The board actually determined that Edward's evidence was more persuasive.

[00:19:57] Speaker 00:
That Appendix 46, it states, we are persuaded by petitioner that it would have been simpler when leaving the flaps behind in the heart post procedure, as suggested by Goldfarb 329.

[00:20:09] Speaker 00:
to attach the flaps to the coupling member 19 or collar 131 rather than to the heart tissue.

[00:20:15] Speaker 00:
So the board found Edward's evidence more persuasive.

[00:20:19] Speaker 00:
But it goes on to state, I believe it's in footnote 16, that even if you could attach, even if the cardiovalve were correct, that those flaps could be attached to the heart wall somehow, that that would have been one of two predictable options, and that it still would have been obvious to a person of skill in the art to couple the flaps to the clips.

[00:20:43] Speaker 00:
The board cited the testimony of Edwards expert Dr. Vesely.

[00:20:47] Speaker 00:
When determining that, Dr. Vesely testified that the flaps could be coupled to the clips and did not stop there.

[00:20:53] Speaker 00:
His testimony was not conclusory.

[00:20:55] Speaker 00:
Dr. Vesely went on to explain why a person of skill in the art would have been motivated to couple the flaps to the clips.

[00:21:03] Speaker 00:
One was so that the flaps remained securely anchored to the atrial side, the top of the leaflets, by attaching the flaps

[00:21:21] Speaker 05:
to the thing that immediately comes to mind, which is flat clip, right?

[00:21:28] Speaker 05:
You're talking about something that's indirect, because I don't see anybody suggesting, or at least can't imagine, how the flat can be connected to 18 or 16, the top and bottom of the clips.

[00:21:41] Speaker 05:
You're talking about connecting it to some little piece, 19, the coupling member that

[00:21:50] Speaker 05:
are closed and there are little things sticking up.

[00:21:53] Speaker 05:
Is that?

[00:21:54] Speaker 00:
Correct, Your Honor.

[00:21:55] Speaker 00:
The board found to start, in terms of framing the issue, that the claims did not require a direct coupling to the clips.

[00:22:02] Speaker 00:
It could be indirect.

[00:22:03] Speaker 00:
And so the board pointed to the portion of the clip that remains behind with the clip, the coupling member.

[00:22:09] Speaker 05:
It has to be indirect, doesn't it?

[00:22:11] Speaker 00:
There was evidence.

[00:22:13] Speaker 05:
18, according to your expert, 18 has to come down through the annulus and not actually touch, through the hole in the annulus, and not actually touch.

[00:22:26] Speaker 05:
And also the bottom of it goes down further than you can because it has to move down below the leaflets so that the 16s, the distal portions, can get clearance to open up.

[00:22:42] Speaker 00:
You've described how the clip works, your honor.

[00:22:45] Speaker 00:
You've described that accurately.

[00:22:46] Speaker 00:
And the test.

[00:22:47] Speaker 04:
So just to be clear, you agree that the flaps could not possibly be directly connected to either the proximal elements or the distal elements of the clip, 16 and 19.

[00:22:59] Speaker 04:
The flaps have to be directly connected to something else in the overall device.

[00:23:07] Speaker 00:
Correct.

[00:23:08] Speaker 00:
The evidence that was submitted is that the flaps would be connected to the coupling member that's left behind with the clip.

[00:23:14] Speaker 00:
Dr. Vesely explained that a person of skill in the art would have reasonably expected success in doing that, because Goldfarb 329 explains that the flaps have cutouts in them to accommodate the movement of the proximal elements.

[00:23:28] Speaker 00:
And so they are specifically designed to be used in conjunction with the clip.

[00:23:32] Speaker 00:
He also explained that by coupling the flaps to the coupling member that does remove it a little further from the moving parts of the of the device and therefore there wouldn't be any interference between the devices.

[00:23:46] Speaker 00:
The board also noted that the devices or means for coupling the flaps to the clips were within the technical grasp of a person of skill in the art and I don't think this is in dispute.

[00:24:00] Speaker 00:
Dr. Vesely had testified that

[00:24:03] Speaker 00:
A person of skill would have used kind of the well-known coupling mechanisms available at the time, rods, pins, hinges.

[00:24:11] Speaker 00:
Some of these are even disclosed in Goldfarb 329 to attach other devices to each other.

[00:24:16] Speaker 00:
Dr. Sacks agreed that those types of mechanisms were, quote,

[00:24:20] Speaker 00:
or that a postheta would have used, quote, any number of conventional mechanical binding or hinge-like mechanisms who went on to describe such mechanisms as obvious design features, very standard, conventional, and well within the state of the art.

[00:24:35] Speaker 00:
So there was really no need to dispute.

[00:24:37] Speaker 05:
Would the connecting mechanism have to prevent these semi-rigid flaps from flapping up if they're connected only at one point on this

[00:24:50] Speaker 05:
19, not quite a post, but it's something like a post.

[00:24:55] Speaker 05:
Correct.

[00:24:56] Speaker 00:
At the vertex, right?

[00:24:57] Speaker 00:
Correct.

[00:24:57] Speaker 00:
And as Dr. Vesely explained, the hinges can easily be used to securely anchor the flaps to the atrial side of the device.

[00:25:06] Speaker 00:
In fact, there are similar hinges shown for the proximal and distal elements in the 329 patent already that are already there.

[00:25:14] Speaker 00:
So they would hold those flaps firmly against the atrial side.

[00:25:17] Speaker 00:
And that was the evidence submitted by Edward's expert on that point.

[00:25:22] Speaker 00:
I'll also just briefly respond to this.

[00:25:26] Speaker 04:
Could you remind us what did the other side, Cardio Valve, say about, as a technical matter, why it cannot be that you would couple the flats to the coupling number 19?

[00:25:40] Speaker 00:
Yeah, I don't believe Cardio Valve specifically rebutted

[00:25:45] Speaker 00:
the allegation or our position that the flaps could be coupled to the coupling member.

[00:25:50] Speaker 00:
They generically stated that that would be unpredictable and instead pointed to other types of art where a device was stapled or glued to the heart valve annulus.

[00:26:03] Speaker 05:
OK, can I just refresh my recollection?

[00:26:09] Speaker 05:
Did Dr. Bessley feel his

[00:26:18] Speaker 00:
He did call that out.

[00:26:19] Speaker 00:
In petition?

[00:26:20] Speaker 00:
In his declaration of supporting the petition.

[00:26:23] Speaker 00:
Correct.

[00:26:24] Speaker 00:
Correct.

[00:26:25] Speaker 04:
That didn't come up in your reply to the preliminary patented response?

[00:26:33] Speaker 00:
I believe it was in the petition, but I can certainly check, yeah.

[00:26:38] Speaker 00:
Yeah, and he gave the reasons for that, the motivation for that, that it would simplify the deployment.

[00:26:46] Speaker 00:
The whole device could be delivered in one procedure, that it could be detached from the delivery device at one time, that it would be safer for the patient, that the procedure would take less time.

[00:26:59] Speaker 00:
So he went through all the different motivations to couple the flaps to the clip.

[00:27:08] Speaker 00:
The board also based its decision on its analysis of the evidence submitted by cardiovalve as well.

[00:27:17] Speaker 00:
The board noted at Appendix 46 the substantial challenges that would have arisen by the methods described by cardiovalve, particularly trying to staple or glue these flaps inside the human heart while it was beating and while there's low visibility.

[00:27:33] Speaker 00:
That was one of the bases for why the board found Edwards' evidence more persuasive that a person of ordinary skill in the art would have found it obvious to couple the flaps to the clips.

[00:27:45] Speaker 00:
The board also noted Dr. Sacks' inconsistent testimony.

[00:27:49] Speaker 00:
Initially, he opined that a person of skill in the art would have coupled the flaps to the heart valve annulus.

[00:27:55] Speaker 00:
During his deposition, he recanted that testimony and said, no, in fact, the flaps would be attached somewhere to the heart valve wall.

[00:28:04] Speaker 03:
What is the evidence and what are the legal requirements for showing that predictable solutions are likely to succeed?

[00:28:15] Speaker 00:
Well the way that KSR has articulated that test was that

[00:28:22] Speaker 00:
The person that's still in the art, there needs to be an articulated reasoning with some rational underpinning.

[00:28:29] Speaker 00:
The analysis does not need to seek out precise teachings directed to the specific subject matter of the challenge plane.

[00:28:36] Speaker 05:
What you're reading from, or what you're reading is not from the paragraph, was it 421 in KSR, unobviousness of the trash?

[00:28:44] Speaker 05:
Correct, correct.

[00:28:45] Speaker 05:
I'm not sure whether that answers the question asked.

[00:28:50] Speaker 00:
I guess if you're getting to the point about what's required, it needs to be a finite number of options with a predictable result.

[00:28:56] Speaker 03:
And you don't think you have to have this also show that, and you're talking about predictable result, is that the likelihood of success or is it both?

[00:29:05] Speaker 03:
It's predictable in terms of the person who ordinary is going to think of it as a solution, but also it has to be a solution that's likely to succeed.

[00:29:13] Speaker 00:
I think those are explaining the same requirement there, that predictability is describing an expectation of success.

[00:29:22] Speaker 00:
And so here the board found not only that it was predictable, Dr. Vestley also explained why there would be an expectation of success.

[00:29:29] Speaker 00:
And again, that goes to Goldfarb 329's description of the flaps as having these cutout regions so that they can function

[00:29:37] Speaker 00:
in conjunction with the other portions of the device.

[00:29:40] Speaker 00:
They're supposed to operate together in unison.

[00:29:43] Speaker 00:
Also, Dr. Vest's opinion that if the flaps are coupled to the coupling member, that that removes it slightly from the clip and would secure the device on the atrial side of the leaflets.

[00:29:55] Speaker 05:
He also provided... Is it relevant to ask whether leaving

[00:30:21] Speaker 05:
explanation of whether that would be an OK thing for the patient.

[00:30:29] Speaker 00:
Correct, Your Honor.

[00:30:29] Speaker 00:
That would be taken as a given because it's disclosed in the prior art.

[00:30:33] Speaker 00:
And there's really no dispute that by cardio valve that the flaps wouldn't be left behind at all.

[00:30:41] Speaker 00:
Both experts opined that the flaps, a person of skill in the art would have found it obvious to leave the flaps behind.

[00:30:47] Speaker 00:
The dispute was just how a person of ordinary still would think that.

[00:30:50] Speaker 04:
The board, at some point in its opinion, said that statement about leaving the flash behind is a statement of fact.

[00:30:56] Speaker 04:
It's not an invitation to speculate about how it might or might not be possible to do that.

[00:31:04] Speaker 00:
Correct, Your Honor.

[00:31:05] Speaker 00:
The board did say that, yes.

[00:31:07] Speaker 00:
Yes.

[00:31:16] Speaker 05:
relevant, and I'll get to that.

[00:31:19] Speaker 05:
There are these, I can't pronounce it, the chordae tendinitis coming off the bottom of the leaf, is that right?

[00:31:28] Speaker 00:
That's correct, Your Honor.

[00:31:28] Speaker 05:
How does distal number 16 interact with those?

[00:31:35] Speaker 00:
It goes between the chordae.

[00:31:37] Speaker 05:
So essentially that chordal connection to the muscle that's in the, or whatever it's called, I guess it's a muscle in the ventricle remains.

[00:31:46] Speaker 00:
That's correct, Your Honor.

[00:31:47] Speaker 00:
Yes.

[00:31:47] Speaker 05:
And now for the trivial question.

[00:31:49] Speaker 05:
Is your goldfarb related to the goldfarb of goldfarb against Kubert, the interference cases he had, and Bart against Gore?

[00:32:02] Speaker 05:
Son?

[00:32:02] Speaker 00:
My understanding is it's the same goldfarb.

[00:32:05] Speaker 00:
No.

[00:32:06] Speaker 00:
He was a prolific inventor.

[00:32:08] Speaker 00:
Sorry, Your Honor.

[00:32:11] Speaker 00:
The same goldfarb.

[00:32:12] Speaker 05:
Not his son.

[00:32:13] Speaker 00:
It may have been his son.

[00:32:14] Speaker 05:
I'm not sure of the reason, but there's a relationship between them.

[00:32:18] Speaker 04:
Could be a relationship with him son.

[00:32:20] Speaker 00:
Could be.

[00:32:24] Speaker 00:
If there are no further questions, I will see the rest of my time.

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

[00:32:35] Speaker 01:
Thank you, Your Honors.

[00:32:35] Speaker 01:
I'd like to start with Dr. Sacks and his supposed admissions, which say nothing about disclosure in the art of coupling clips to flaps.

[00:32:44] Speaker 01:
This is the admissions from Dr. Sacks and what Dr. Sacks was saying on the record.

[00:32:48] Speaker 01:
It was all about where you would couple to the native heart tissue itself.

[00:32:53] Speaker 01:
The coupling to the native heart tissue itself is the closest prior art we have about how to leave behind flaps.

[00:32:59] Speaker 04:
Never leave the atrial wall, not the annulus, right?

[00:33:03] Speaker 01:
Well, Sachs talks about the atrial wall, and then there is prior art talking about to the anulus.

[00:33:08] Speaker 04:
Because he said you wouldn't do it to the anulus because that would affect the operation.

[00:33:12] Speaker 01:
That is what he said, correct.

[00:33:14] Speaker 04:
And your prior art references were about examples of connecting something to a valve anulus.

[00:33:21] Speaker 01:
The stabilizers to the anulus, that's right, except for a zippery, which is to the atrial wall.

[00:33:26] Speaker 01:
Correct.

[00:33:27] Speaker 01:
So I think the discussion of Dr. Sachs and what that evidence presents is a cardiovalve doesn't have a burden to show obviousness here.

[00:33:37] Speaker 01:
The board in fact found that it said that cardiovalve doesn't have a burden to show non-obviousness here.

[00:33:43] Speaker 01:
So faulting the closest prior art in a situation where there is no prior art and no other evidence other than

[00:33:51] Speaker 01:
the conclusory statements of Dr. Vesely, it doesn't exist in the prior art to couple the flaps to the cliffs.

[00:34:00] Speaker 01:
The prior art that we have here, Gulf Harbor 329, only says it may be left behind.

[00:34:06] Speaker 01:
That, in our view, is not enough for an obvious to try legal framework where the priority is only a vague suggestion about what to do next and there is no guidance about how to come to the conclusion of the patented invention here.

[00:34:25] Speaker 01:
Using an obvious to try framework in this scenario is replete with hindsight.

[00:34:30] Speaker 01:
The only way to get to the

[00:34:33] Speaker 01:
The missing structural limitation is to take the obvious-to-try framework and have it be guided by what you're trying to find, which is coupling the leaflets to the flaps.

[00:34:45] Speaker 01:
The only place we have that anywhere is in the 341 patent itself to cardio valve.

[00:34:53] Speaker 01:
The standard, the board asked the wrong question, we think.

[00:34:56] Speaker 01:
It's not whether it could possibly work to couple the clips to the flats.

[00:35:02] Speaker 01:
It's what was known to Opposa at the time of the invention.

[00:35:06] Speaker 01:
And that just decidedly was not known.

[00:35:09] Speaker 01:
There's no cases that we've seen from the board or from Edwards in the briefing where a missing structural limitation is

[00:35:20] Speaker 01:
is found to be obvious to try.

[00:35:22] Speaker 03:
I asked you my likelihood of success argument.

[00:35:25] Speaker 03:
I don't see you making a likelihood of success argument, but do you think the likelihood of success requirement is separate from the predictability requirement?

[00:35:32] Speaker 01:
I do, Your Honor, and that is something that, because of how this came up in the proceeding during the oral argument itself, that cardiovalve did not have a chance to add expert testimony or cross-examine.

[00:35:43] Speaker 01:
on because the obvious-to-try scenario was something that was not put forward until actual oral argument and then the parties had seven pages.

[00:35:53] Speaker 03:
I don't see where you're arguing a lack of likelihood of success on appeal.

[00:35:57] Speaker 03:
Am I missing that?

[00:35:59] Speaker 01:
I don't think you necessarily are, Your Honor.

[00:36:04] Speaker 01:
So Cardiovalve asked for reversal for the reasons stated.

[00:36:08] Speaker 01:
Thank you very much.