[00:00:14] Speaker 00:
The United States Court of Appeals for the Federal Circuit is now open and in session.

[00:00:20] Speaker 00:
God save the United States and this honorable court.

[00:00:22] Speaker ?:
Thank you.

[00:00:23] Speaker 04:
You're seated.

[00:00:30] Speaker 04:
OK, the first argued case this morning is number 151696 in Rayathakan, Mr. Uchi.

[00:00:37] Speaker 02:
Good morning, Your Honor.

[00:00:40] Speaker 02:
The board erred as a matter of law by failing to identify any credible reason why a person of ordinary skill who did not already have knowledge of the claimed inventions would have consulted the cited publications and then combined them in the proposed manner.

[00:00:54] Speaker 02:
The board's finding of obviousness lacks substantial evidence that a person of ordinary skill who did not already have the benefit of this hindsight would have combined the respective teachings of the tuck, two, and low patents and would have done so in the proposed manner.

[00:01:08] Speaker 02:
The first finding by the board that lacked substantial evidence relates to the Tuck patent.

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Tuck is directed to a polymer-coated stem.

[00:01:18] Speaker 02:
And it describes that polymer coating by reference to a list of 50 polymers and polymer classes embracing thousands of polymers.

[00:01:26] Speaker 02:
It's a very extensive disclosure.

[00:01:28] Speaker 03:
But it does disclose polyvinylidene.

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Pay lives, right?

[00:01:35] Speaker 02:
It does, Your Honor.

[00:01:36] Speaker 03:
And then when you add low, it's got the 15, 85% hexafluoropropane.

[00:01:47] Speaker 03:
These are all very closely related.

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It looks almost like a 102.

[00:01:54] Speaker 02:
With respect, Your Honor, I don't believe they're closely related, nor do I believe it's nearly a 102.

[00:02:00] Speaker 02:
The rejection that has been

[00:02:03] Speaker 02:
put forth by the board is one of tuck combined with two combined with low.

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Now, in main point, one of the differences between low and tuck is that low is directed to polymers for use in harsh industrial applications, not a device that's going to be placed in the human body.

[00:02:21] Speaker 03:
It does show an equivalence between the

[00:02:28] Speaker 03:
What?

[00:02:28] Speaker 03:
The tetrafluoro, vanilidine, and the hexafluoropropene?

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And it does show an equivalence there.

[00:02:35] Speaker 02:
Equivalence in what respect, Your Honor?

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I don't believe it does show equivalence to VDF.

[00:02:40] Speaker 02:
One of the problems with Tuck is this disclosure of just VDF.

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Where the board erred with respect to Tuck is its conclusion that a person reading Tuck would not have been satisfied with this vast list of polymers they have.

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would have ventured beyond the four corners of the document, and would have consulted a document like two.

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As you know.

[00:03:01] Speaker 05:
But tuck and two are in very similar areas.

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And your own patent talks about possible applications beyond stents, right?

[00:03:15] Speaker 02:
It does, Your Honor.

[00:03:16] Speaker 02:
Both tuck and two are related to devices which are placed in the body.

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But the nature of those devices is very different.

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Tuck is directed to a stent.

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which is in contact with flowing blood.

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Two, the main focus in two, the central focus in two, is on vascular grafts.

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And two, very specifically, two's invention, if you will, is a multilayered structure.

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And that multilayered structure is significantly different.

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What it's directed to is vascular grafts, basically a form of a two.

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The internal portion of that tube is described by Tuck as being polytetrafluorethylene, Teflon, a very hydrophobic surface.

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And that hydrophobic surface is important because that's what you want in contact with flowing blood.

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You don't want a hydrophilic surface in contact with flowing blood.

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And what Tuck does is he builds on that, the multi-layered structure.

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The internal portion is polytetrafluorethylene.

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The next layer out is a blend of an elastomer and polytetrafluorethylene.

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And then an optional third layer,

[00:04:13] Speaker 02:
is an elastomer.

[00:04:14] Speaker 02:
Now, among the elastomers there, there are 13 compounds.

[00:04:17] Speaker 05:
I thought you also suggested the use of this compound on the inner part of the lumen, all right?

[00:04:25] Speaker 02:
In a very limited way, Your Honor.

[00:04:27] Speaker 02:
And that's the alternate embodiment that the board and the PTO reference in their brief.

[00:04:34] Speaker 02:
They reference it incompletely.

[00:04:38] Speaker 02:
Again, what Tu talks about is having polytetrafluorethylene on the internal portion

[00:04:44] Speaker 02:
blend of elastomer polytetrafluoroethylene and an optional layer.

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The alternate embodiment to which you're referring has two additional layers.

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Two additional layers, and that's important.

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Yes, internal to that polytetrafluoroethylene layer that I mentioned, they do talk about putting in elastomer.

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But importantly, they don't stop there.

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They talk about putting another layer internal to that that has polytetrafluoroethylene again.

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A barrier layer against that elastomer to make sure that the elastomer does not contact glowing blood.

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So even that alternate embodiment, which puts the elastomer internal to the first polytetrafluoroethylene layer that I mentioned, it puts it inside of it.

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It's very important that they don't leave it there to contact flowing blood.

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They make sure that they put another barrier layer of polytetrafluoroethylene inside of it.

[00:05:30] Speaker 02:
That's a very significant portion of two in this alternative embodiment that the patent office does not mention completely in their briefing, and the board didn't address completely in their decision.

[00:05:44] Speaker 05:
So one reason that the board... Do you make that point in your brief?

[00:05:47] Speaker 05:
What's that?

[00:05:47] Speaker 05:
Do you make that point in your brief?

[00:05:48] Speaker 02:
Yes, your honor.

[00:05:51] Speaker 05:
Where?

[00:05:58] Speaker 02:
Will you please continue while your colleague searches for it?

[00:06:02] Speaker 02:
Yes, thank you.

[00:06:04] Speaker 02:
One reason that the board gives for someone to go beyond the disclosure of Tuck is that Tuck allegedly discloses the importance of elasticity

[00:06:13] Speaker 02:
in connection with the polymeric stent coating.

[00:06:15] Speaker 02:
Significantly, Tuck doesn't actually provide that disclosure.

[00:06:18] Speaker 02:
Tuck mentions elasticity only in connection with another layer that can be placed on top of the polymeric stent coating, what they refer to as an overlayer.

[00:06:29] Speaker 02:
There's only one section in Tuck, a very limited section of two paragraphs, where they talk about elasticity only in connection with this overlayer.

[00:06:38] Speaker 02:
And even there, elasticity is mentioned as being a relevant consideration, but not a dispositive one.

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In fact, Tuck in this portion says that even inelastic columnars can be used so long as they are made porous.

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So Tuck does not talk about elasticity in the broader context of its primary stent coding.

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It talks about it only in connection with this overlayer and not being a dispositive consideration.

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disclosed the importance of elasticity for its primary stent coating is revealed by an internal consistency in the board's argument.

[00:07:14] Speaker 02:
As I mentioned earlier, Tuck identifies PDF as one of thousands of polymers.

[00:07:19] Speaker 05:
But if elasticity was as important to Tuck as the board alleges... So once you get the combination of Tuck and two, then you're dealing with a single polymer, right?

[00:07:32] Speaker 05:
And that single polymer is addressed in love.

[00:07:36] Speaker 05:
the ratio?

[00:07:38] Speaker 02:
Not exactly, your honor.

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The polymer that's disclosed in Tuck is VDF.

[00:07:46] Speaker 02:
We believe there's insubstantial evidence for someone to... No, Tuck and two.

[00:07:50] Speaker 05:
If you take the two of them together, you've got VDF-HFP, right?

[00:07:54] Speaker 05:
And that's a single polymer, and then you're looking... It's not as though you've got a huge genus

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that you're concerned with.

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And when you look to low, you're looking for the disclosed ratio with respect to that single polymer.

[00:08:09] Speaker 05:
Is that not correct?

[00:08:13] Speaker 02:
One gets there only by not considering the full disclosure of two.

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Is what I say correct or not?

[00:08:19] Speaker 02:
If one focuses on BDFHFP in two and then goes to low,

[00:08:25] Speaker 02:
Notwithstanding the fact that it's directed to industrial applications, one could come to the invention that way.

[00:08:30] Speaker 05:
Right, and we're dealing with a single polymer once you make the combination of Tuck and Tuq.

[00:08:35] Speaker 02:
Having selected VDF-HFP from the thousands of choices disclosed in Tuq, that's correct.

[00:08:42] Speaker 02:
So as I'm saying, the alleged importance of elasticity in Tuq is belied by an internal inconsistency in the documents.

[00:08:51] Speaker 02:
If elasticity was as important to Tuq as the board alleges,

[00:08:55] Speaker 02:
The question that arises is, why does Tuck even mention VDF?

[00:09:00] Speaker 02:
Now, it's important to note that later on in the patent office's arguments, in connection with the low reference, they acknowledge that VDF is not an elastic polymer.

[00:09:10] Speaker 02:
It's a crystalline inelastic polymer.

[00:09:13] Speaker 02:
So if elasticity is so important to Tuck, and that's the basis that the patent office has to go beyond the disclosure of Tuck, why did they list the VDF?

[00:09:23] Speaker 02:
The answer is, is that elasticity isn't as important to Tuck, isn't as central to Tuck as the board alleges.

[00:09:29] Speaker 02:
The board merely provided that reason in support of a combination of references that had already sanctioned.

[00:09:37] Speaker 02:
Now again, we believe that because of this lack of focus on elasticity, the lack of substantial evidence on that issue, someone wouldn't have gone beyond Tuck.

[00:09:46] Speaker 02:
They would have taken a look at Tuck, thousands of choices there, and would have made some selection from within.

[00:09:51] Speaker 02:
But even if one did go to two,

[00:09:53] Speaker 02:
for some reason.

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There's insubstantial evidence that someone would have combined TUCN2 in a way that would have produced acclaimed invention.

[00:10:01] Speaker 02:
2, as I mentioned, is directed to this tubular structure where you have one layer upon another, PTFE and then elastomer being optional on the outside of it.

[00:10:11] Speaker 02:
The layers are arranged in a particular way so that the hydrophobic, blood-compatible PTFE layers on the inside in contact with flowing blood and the hydrophilic, tissue-compatible elastomer layer

[00:10:23] Speaker 02:
is on the outside.

[00:10:24] Speaker 02:
The reason for this arrangement of the respective layers is provided by two's disclosure that it's not desired to have the elastomer come in contact with flowing blood.

[00:10:34] Speaker 02:
On the basis of this teaching, Dr. Mikos, one of the declarants, confirmed that one of ordinary skill would not have been expected that a VDF-HFP elastomer would be suitable for a blood contacting type of scenario.

[00:10:47] Speaker 02:
The board gives two reasons for not being persuaded by this disclosure in two and by Dr. Mikos' testimony.

[00:10:54] Speaker 02:
But neither of these reasons is supported by substantial evidence.

[00:10:57] Speaker 02:
First, the board noted that notwithstanding 2's central focus on vascular grafts, 2 mentions in passing that its multilayered structure can be used on other types of products, gives a number of them, including valve leaflets.

[00:11:11] Speaker 02:
The board noted that valve leaflets are in contact with flowing blood, and hypothesized that having a last number layer of 2 in contact with blood must not really have been that undesirable

[00:11:22] Speaker 02:
if it could be used on a valve leaflet.

[00:11:24] Speaker 02:
But there's no evidentiary support for this.

[00:11:26] Speaker 02:
The hypothesis, there's no evidentiary support for the hypothesis that it's okay to put the elastomer in contact with blood.

[00:11:32] Speaker 02:
In fact, the evidence is directly to the contrary.

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And that's because, as I mentioned earlier, two specifically states that that outer layer of elastomer is optional.

[00:11:42] Speaker 02:
Now, think about that.

[00:11:43] Speaker 02:
There's two points in two.

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Contact between the elastomer and the blood is undesirable.

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And the elastomer is optional.

[00:11:53] Speaker 02:
The only reasonable inference that can be drawn from that is that in the environment of flowing blood, such as you find in valve leaflets, an elastomer layer, the optional elastomer layer, should simply not be used.

[00:12:06] Speaker 02:
The second reason that the board gave for not crediting to the statement that elastomer should not be in contact with flowing blood is the two discloses of this alternative embodiment.

[00:12:15] Speaker 05:
And as I mentioned...

[00:12:18] Speaker 02:
Page four.

[00:12:19] Speaker 05:
Where you made the argument that in the alternative embodiment there's another inner layer?

[00:12:28] Speaker 02:
Sure.

[00:12:28] Speaker 02:
Your Honor, the argument was made in our reply brief.

[00:12:32] Speaker 02:
The PTO's brief to which we responded was at page 33, the second full paragraph.

[00:12:38] Speaker 02:
The portion of our brief where we responded to that and discussed the alternative embodiment is at page 11, the first full paragraph.

[00:12:47] Speaker 05:
Make reference to this additional inner layer?

[00:12:49] Speaker 02:
The middle of page 11, Your Honor, where we say the director tries a different tact, arguing the two elsewhere discloses an inner layer comprising a blend of PTE and elastomer.

[00:13:04] Speaker 05:
I don't see it, but go ahead.

[00:13:10] Speaker 04:
Let's hear from the other side.

[00:13:12] Speaker 04:
We'll save you rebuttal time, and if you need to find

[00:13:14] Speaker 04:
more pages to respond to Judge Icke's question, that would be helpful.

[00:13:19] Speaker 02:
Yes, thank you, Your Honor.

[00:13:22] Speaker 04:
Okay.

[00:13:22] Speaker 04:
Ms.

[00:13:22] Speaker 04:
Rashid.

[00:13:29] Speaker 01:
May it please the Court, to pass to using 8515 BDF-HFP as a drug containing polymer coating for a balloon expandable stent could not have been more straightforward here.

[00:13:40] Speaker 04:
Let me ask you a preliminary question.

[00:13:43] Speaker 04:
that this was an inter-parties proceeding before the board.

[00:13:46] Speaker 04:
Isn't that right?

[00:13:48] Speaker 01:
It was an inter-parties re-examination proceeding before the board, yes.

[00:13:53] Speaker 04:
OK.

[00:13:54] Speaker 04:
And so the petitioners, the prevailing parties, have declined to defend the decision in their favor.

[00:14:00] Speaker 04:
Isn't that right?

[00:14:01] Speaker 01:
I believe that's correct.

[00:14:03] Speaker 01:
They have settled and dropped out of the case.

[00:14:07] Speaker 04:
So where is the case of controversy in this situation?

[00:14:15] Speaker 01:
We have the other side challenge.

[00:14:17] Speaker 04:
The office was not a party.

[00:14:18] Speaker 04:
They were the judge.

[00:14:21] Speaker 04:
And so this is a matter of the judge coming forward to say, I got it right, even though the prevailing party doesn't want to defend it.

[00:14:32] Speaker 01:
Your Honor, we're here really just to help the court.

[00:14:35] Speaker 01:
We thought it would be beneficial for the court to have both sides represented.

[00:14:39] Speaker 01:
We think the board's decision is correct, and we're here to answer any questions.

[00:14:42] Speaker 04:
The office didn't request?

[00:14:45] Speaker 04:
authorization from the court to help us?

[00:14:52] Speaker 01:
We intervened in this case initially to defend procedural issues in this case.

[00:14:58] Speaker 04:
Well, I think it's curious because we know by the statute that if the petitioner withdraws either during the preliminary stage or before the decision, the case is dismissed.

[00:15:11] Speaker 04:
And so why is this any different?

[00:15:13] Speaker 04:
The petitioners who withdrawn

[00:15:16] Speaker 03:
Is it your view that we have an appeal?

[00:15:19] Speaker 03:
We have an appeal from someone who lost in the office.

[00:15:22] Speaker 03:
And whether you're here or not, we have a case of controversy?

[00:15:26] Speaker 01:
That's correct, Henry.

[00:15:27] Speaker 04:
We have a- Where is the controversy?

[00:15:30] Speaker 01:
The controversy is that we have Ethicon here challenging the board's decision.

[00:15:36] Speaker 04:
But where are the parties?

[00:15:38] Speaker 04:
The board is not a party to the controversy, right?

[00:15:43] Speaker 04:
The office is not a party to the controversy.

[00:15:46] Speaker 04:
Why is there a continuing controversy to fill the courts?

[00:15:53] Speaker 05:
Doesn't this happen frequently in the Supreme Court where only one party chooses to appear before the Supreme Court and the Supreme Court appoints an amicus to defend the other side and resolves the case, even though one party doesn't take the position?

[00:16:07] Speaker 04:
Do you know of such a case?

[00:16:08] Speaker 04:
I think that when the complainant withdraws, that ends the case.

[00:16:15] Speaker 04:
We have a problem here as well with the statute which provides for withdrawal at varying stages.

[00:16:24] Speaker 04:
I think we should think about that and I invite the office to tell us what you think.

[00:16:31] Speaker 04:
This of course isn't the only case in which the office has come in to act when one party has withdrawn.

[00:16:40] Speaker 03:
Is this the equivalent of an ex-party appeal at this point?

[00:16:43] Speaker 01:
I believe it is, Your Honor.

[00:16:44] Speaker 01:
Inter-party's re-examination is very much like an ex-party re-examination.

[00:16:47] Speaker 01:
That's what the inter-party's re-examination statute says.

[00:16:50] Speaker 01:
It is governed like an ex-party case.

[00:16:52] Speaker 01:
In ex-party cases, the PTO appears to defend the board's decision, and that's why we're here.

[00:16:56] Speaker 04:
We see it in the re-examination.

[00:16:59] Speaker 04:
We see it in the inter-party's review.

[00:17:02] Speaker 01:
But those are two very different proceedings.

[00:17:03] Speaker 04:
And indeed, this is an ex-party appeal, I agree, because the other side has declined to defend.

[00:17:09] Speaker 04:
And so it becomes ex parte.

[00:17:13] Speaker 01:
I don't think that's right.

[00:17:14] Speaker 01:
An inter-party's re-examination is very much like an ex-party re-examination, which is governed just like any other examination is governed.

[00:17:24] Speaker 01:
And this is not a case where you have, it's not like an inter-party's review type of action where there are two parties dueling it out.

[00:17:33] Speaker 01:
It's very much like that.

[00:17:34] Speaker 03:
Since you're here, why don't you defend the merits?

[00:17:37] Speaker 04:
Yes, please proceed with the merits.

[00:17:39] Speaker 04:
I'd be interested in the office's position, because it's not limited to reexamination.

[00:17:50] Speaker 01:
I suppose we can provide an opinion, but that's not an issue in this case.

[00:17:56] Speaker 01:
With regards to the merits of this case, we believe that this is a textbook 103, obviousness determination.

[00:18:04] Speaker 01:
Tuck teaches drug eluding stents with a polymer coating containing a drug.

[00:18:09] Speaker 01:
Tuck specifies many requirements for its polymer coating.

[00:18:13] Speaker 01:
It recognizes that the polymer plays two roles.

[00:18:16] Speaker 01:
One role is to serve as a barrier between the stems and the tissue, and the second role is for it to serve as a platform for drug delivery to the surrounding area.

[00:18:27] Speaker 01:
Its role is serving as a barrier.

[00:18:28] Speaker 01:
Because it serves as a barrier, it raises issues of biocompatibility.

[00:18:33] Speaker 01:
So Tuck requires the polymer to be biocompatible.

[00:18:36] Speaker 01:
and so that it doesn't injure the surrounding tissue.

[00:18:39] Speaker 01:
It specifically says it must be biocompatible and it must minimize irritation when it's implanted.

[00:18:45] Speaker 01:
It also talks about low chronic tissue response from the polymer.

[00:18:50] Speaker 01:
It also says that the polymer has to have some level of biological stability.

[00:18:55] Speaker 01:
In addition to biocompatibility properties, Tuck also says that the polymer has to exhibit some mechanical properties, specifically elasticity.

[00:19:05] Speaker 01:
It must be resilient and flexible to withstand the force of the scaffolding when it expands.

[00:19:11] Speaker 01:
And it must provide a predictable platform to allow for drug delivery, so that either through pores or through erosion, depending on what type of polymer that you choose.

[00:19:21] Speaker 01:
Tuck does provide a library of polymers, but all those polymers meet these requirements of biocompatibility and elasticity.

[00:19:32] Speaker 04:
But what is there to lead

[00:19:34] Speaker 04:
to this particular polymer to select this particular product from the vast and undifferentiated list?

[00:19:46] Speaker 01:
Tuck describes the properties that are required for its drug eluting stent.

[00:19:52] Speaker 01:
It describes the biocompatibility properties and it describes the mechanical properties.

[00:19:59] Speaker 01:
Based on those properties, a person of skill in the art

[00:20:02] Speaker 01:
would recognize that 2's VDF-HFP has those properties because that's what 2 teaches.

[00:20:09] Speaker 01:
2 teaches that VDF-HFP is biocompatible with surrounding tissue.

[00:20:14] Speaker 01:
It teaches that it has excellent elasticity, strength, and that it is applicable across a broad application of medical devices.

[00:20:22] Speaker 01:
It also says that it can serve as a platform for drug delivery.

[00:20:26] Speaker 01:
Based on those teachings, that is what would lead a person of skill in the art to VDF-HFP, based on the combination of TUCN2.

[00:20:33] Speaker 03:
Does Lowe discuss the 15-85% hexa- and tetra-copolymer?

[00:20:41] Speaker 01:
Yes, it does.

[00:20:42] Speaker 03:
Lowe specifically teaches that VDF-85- The only thing it doesn't discuss is use in a stent.

[00:20:51] Speaker 01:
It doesn't specifically discuss stents, but it does say that it is applicable across, it has a wide variety of commercial use.

[00:21:00] Speaker 01:
Lowe says that.

[00:21:01] Speaker 03:
But related materials have been in use in stents.

[00:21:04] Speaker 01:
That's right.

[00:21:05] Speaker 03:
Tuck and two.

[00:21:08] Speaker 01:
That's right.

[00:21:08] Speaker 01:
Tuck and two show that related materials have been used in stents.

[00:21:12] Speaker 01:
What Lowe shows you is that VDF-HFP is a well-known polymer with well-known characteristics, well-known properties, and that it is readily available.

[00:21:21] Speaker 04:
Is it known that it has this property of releasing the drug as well as the elasticity?

[00:21:29] Speaker 01:
That comes from 2.

[00:21:32] Speaker 01:
2 tells you that VDF-HFP... That comes from hindsight.

[00:21:36] Speaker 01:
I'm not sure it comes from hindsight, Your Honor, because the reference itself teaches you those biocompatibility and elasticity properties of VDF-HFP when it comes to serving as a platform for a drug release.

[00:21:52] Speaker 01:
But I don't think that's hindsight.

[00:21:53] Speaker 04:
No, the elasticity, I agree.

[00:21:56] Speaker 04:
The problem is the combination of properties.

[00:22:01] Speaker 01:
Combination of properties.

[00:22:04] Speaker 01:
They have the same properties.

[00:22:05] Speaker 04:
They have elasticity, but not the release of the drug.

[00:22:09] Speaker 01:
That is related.

[00:22:11] Speaker 01:
What Tuck teaches us is that it is the resilient matrix of the drug and the polymer that controls

[00:22:21] Speaker 01:
drug elution.

[00:22:22] Speaker 01:
Tuck tells us that.

[00:22:25] Speaker 01:
So from that, you know that elasticity is relevant to drug delivery, to the time that it takes for a drug to either elute from the polymer or to erode from the polymer.

[00:22:37] Speaker 01:
There is a teaching that connects elasticity to drug delivery in Tuck.

[00:22:48] Speaker 01:
Lowe also teaches that 8515 has desirable characteristics such as that optimal balance of elasticity and strength, so it only makes sense for a person of skill in the art to use it because it is an off-the-shelf, readily available, commercially marketed polymer.

[00:23:05] Speaker 01:
whether you describe this combination as a substitution of VDF or VDF or HFP for VDF or whether you say that it is the combination of known elements performing their known function without any unpredictability here, either way, either rationale supports the board's finding here of obviousness.

[00:23:26] Speaker 01:
And not only that, you also even have a specific

[00:23:29] Speaker 01:
teaching about a motivation to combine.

[00:23:32] Speaker 01:
Tuck specifically talks about the need for elasticity.

[00:23:36] Speaker 01:
Not only does it talk about it in terms of a resilient matrix, it also talks about it in the context of an overlay or made of the same polymer and explains that when that polymer in Tuck, which would be VDF, is uniform, that it can lead to cracking.

[00:23:52] Speaker 01:
And Tuck provides one solution to that problem and says, well, one thing you can do is you can make it more porous.

[00:23:59] Speaker 01:
but a person with skill in the art looking at that teaching would readily think that another solution to that problem is to also find a way to make that VDF more elastic.

[00:24:09] Speaker 01:
And two, tells you exactly that when you have VDF, HFP together, that it is more, it makes VDF more elastic.

[00:24:23] Speaker 01:
I just wanted to make one point about

[00:24:28] Speaker 01:
two that the other side raised about that there's a teaching away in two from using VDF-HFP the elastomer in the luminal layer.

[00:24:42] Speaker 01:
I don't think that's right.

[00:24:43] Speaker 01:
I think that is a mischaracterization of that teaching.

[00:24:46] Speaker 01:
And two, it is a misunderstanding of column eight, where it talks about an additional process step, an additional elastomer.

[00:24:55] Speaker 01:
And it also not only does it misunderstand column eight, but it also goes on and ignores the other embodiment, which clearly says that the elastomer can be in the luminal layer and can be in contact with blood.

[00:25:08] Speaker 01:
There's a clear teaching into that

[00:25:12] Speaker 01:
You can have various degrees of hydrophobicity and hydrophilicity throughout the asymmetric layers.

[00:25:20] Speaker 05:
So the alternative embodiment in two doesn't teach an additional layer to prevent blood contact?

[00:25:27] Speaker 01:
The alternative embodiment in two is not saying it's like an optional elastomer layer.

[00:25:36] Speaker 01:
It's saying that you can have

[00:25:38] Speaker 01:
the elastomer in the luminal layer.

[00:25:41] Speaker 05:
And it doesn't show another layer on top of the elastomer layer.

[00:25:43] Speaker 01:
Not that I know of.

[00:25:44] Speaker 01:
Not that I'm aware of.

[00:25:45] Speaker 01:
And I don't remember them raising.

[00:25:46] Speaker 01:
I don't see that they argued that.

[00:25:47] Speaker 01:
And I don't think they argued that before this court.

[00:25:55] Speaker 01:
One final point on whether or not a person of skill in the art would turn to low.

[00:25:59] Speaker 01:
It only makes sense to turn to low because the picture that Ethicon is trying to paint is that this biomaterial scientist is working in isolation and not talking to anyone about other references or collaborating with other scientists.

[00:26:15] Speaker 01:
The nature of drug delivery devices, the nature of implantable devices is that it's a collaborative effort between

[00:26:24] Speaker 01:
not just biomaterial scientists, but also chemists, and physicians, and cardiologists, and other researchers in that area, and they work together.

[00:26:35] Speaker 01:
And you have all of that information available to you.

[00:26:38] Speaker 01:
And it is commonly known that industrial polymer applications eventually can be used for medical applications down the line.

[00:26:46] Speaker 01:
The fact that they were initially found in an industrial setting, that doesn't mean that they can't be used in a medical application.

[00:26:54] Speaker 01:
Well, that's all I have.

[00:26:56] Speaker 01:
If you have any other further questions, I can address those, if not.

[00:27:00] Speaker 04:
Thank you, Ms.

[00:27:01] Speaker 04:
Richie.

[00:27:01] Speaker 04:
Thank you.

[00:27:08] Speaker 04:
Mr. Rich.

[00:27:09] Speaker 02:
Yes, thank you.

[00:27:10] Speaker 05:
If I may address this.

[00:27:11] Speaker 05:
You don't contend that this case has moved as a result of Boston Scientific's not appearing here, do you?

[00:27:17] Speaker 02:
We haven't contended that in our briefing, Your Honor.

[00:27:20] Speaker 02:
We didn't take a position on that issue.

[00:27:23] Speaker 03:
It would be strange if you did, because you're appealing your loss in the patent office.

[00:27:28] Speaker 02:
We are, Your Honor.

[00:27:29] Speaker 02:
You want to have your appeal heard, right?

[00:27:31] Speaker 02:
If our appeals heard and decided in our favor on some procedural issue, we'd be fine with that, Your Honor.

[00:27:39] Speaker 02:
If I may, I'd like to address this idea about the alternative embodiment.

[00:27:43] Speaker 02:
It's in the record at JA 10718.

[00:27:46] Speaker 02:
It's the paragraph in column 9 beginning at line 55.

[00:27:51] Speaker 02:
It says an alternate embodiment comprises a luminal layer of PTFE and a second layer of a PTFE slash elastomer and a second layer of PTFE.

[00:28:04] Speaker 02:
It states that very clearly.

[00:28:05] Speaker 02:
This combination of layers provides for better hydrophilicity due to the elastomer in the luminal layer.

[00:28:12] Speaker 02:
So they clearly say they add two things, elastomer and a second layer of PTFE.

[00:28:18] Speaker 02:
It's right there in the record.

[00:28:20] Speaker 02:
The Patent Office mentioned here that there was no unpredictability in any of this.

[00:28:25] Speaker 02:
This is a highly unpredictable art.

[00:28:27] Speaker 02:
There are thousands of polymers disclosed in just Tuck.

[00:28:31] Speaker 02:
All the evidence of record is that you need a unique balance of properties to have something which has the requisite properties

[00:28:42] Speaker 02:
Notably, releasing the drug at the appropriate rate.

[00:28:45] Speaker 02:
There's no suggestion in Lowe about anything about drug release.

[00:28:49] Speaker 02:
It talks about flexibility.

[00:28:51] Speaker 02:
It talks about use in industrial environments.

[00:28:53] Speaker 02:
The drug release feature which is missing from Lowe is significant.

[00:28:57] Speaker 02:
The patent office mentioned that this is a textbook, allegedly a textbook case of obviousness.

[00:29:02] Speaker 02:
The pieces are all there.

[00:29:04] Speaker 02:
It's a textbook case of hindsight.

[00:29:06] Speaker 02:
One has to place themselves in the shoes of a person of ordinary skill who didn't have the benefit of our patent.

[00:29:12] Speaker 02:
Each of us has been infected, in a way, with the knowledge of our patent claims.

[00:29:15] Speaker 02:
And we're seeing the references in a different light.

[00:29:17] Speaker 02:
We have to step back and put ourselves in the shoes of someone of ordinary skill in the art and ask, if someone had Tuck in front of them in those thousands of choices, would they have focused on VDF?

[00:29:27] Speaker 02:
Would they have focused on VDF because it's allegedly elastic?

[00:29:30] Speaker 02:
It's not elastic.

[00:29:31] Speaker 02:
But that's what the patent office has said.

[00:29:33] Speaker 02:
And would they have taken that disclosure of VDF and modified it in some way?

[00:29:37] Speaker 02:
The answer is that they wouldn't have.

[00:29:38] Speaker 02:
Pursuant to kinetic concepts, they wouldn't have gone

[00:29:41] Speaker 02:
beyond the disclosure of Tuck.

[00:29:47] Speaker 02:
The PTO also mentioned this idea that Tuck discloses VDF and two discloses VDF-HFP.

[00:29:56] Speaker 02:
Let's all be clear on the record.

[00:29:58] Speaker 02:
Each of those is one of thousands of polymers that are mentioned.

[00:30:01] Speaker 02:
The disclosure of Tuck and two, where they talk about different arrangements of polymers, is exceedingly generic.

[00:30:08] Speaker 02:
They only refer to these things as being elastomers or polymers.

[00:30:11] Speaker 02:
There's no focus on VDF in Tuck.

[00:30:14] Speaker 02:
There's no focus on VDF HFP in two.

[00:30:17] Speaker 02:
So let's all be clear on the record, it's misleading what the patent office said about these to suggest otherwise.

[00:30:29] Speaker 02:
The patent office also mentioned in Tuck that this importance about the properties like biocompatibility and elasticity.

[00:30:35] Speaker 02:
As I mentioned, elasticity is not a focus of Tuck

[00:30:38] Speaker 02:
And in fact, that it isn't a focus of Tuck is indicated by this internal consistency in listening in Tuck.

[00:30:45] Speaker 02:
VDF, which according to the Patent Office elsewhere in its arguments, is an inelastic polymer.

[00:30:56] Speaker 02:
So for the reasons stated, we believe that the decision of the board should be reversed.

[00:31:01] Speaker 04:
Any more questions?

[00:31:02] Speaker 04:
Thank you.

[00:31:03] Speaker 04:
Thank you both.

[00:31:04] Speaker 04:
The case is taken under submission.