[00:00:28] Speaker 02:
The next argued case is number 17-2255, Enray-MacKent Cardiovascular Analysty, East O'Clock.

[00:00:39] Speaker 03:
Good morning, Your Honors, and may it please the Court.

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The invention that is the subject of this application is a vascular graft having a textile layer and an expanded polytetrafluoroethylene layer, commonly referred to as PTFE.

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Substance may be familiar to you as Teflon.

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It's used in nonstick pans and other extremely slippery applications.

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These two layers are bonded to one another by an adhesive.

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As you can imagine, the field of vascular stents is an extremely crowded field.

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Yet at the time of this invention in 2001, no one had succeeded in making a graft having a textile layer

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and an expanded polytetrafluoroethylene layer bonded together.

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And the primary reason for this, as explained throughout the prosecution record, was that it was well understood to be exceptionally difficult to bond PTFE to anything, much less a textile layer that is going to be inserted into someone's body.

[00:01:52] Speaker 00:
Well, the board acknowledged, how do I pronounce your client?

[00:01:56] Speaker 00:
Is it McKay?

[00:01:58] Speaker 03:
McKay, Your Honor.

[00:01:59] Speaker 00:
Okay.

[00:02:00] Speaker 00:
The board acknowledged McKay's evidence that it's difficult to bond to the PTFE, but they found that Dew, I believe, provides a solution to the problem because it lists, you know, the nine types of polymers and

[00:02:18] Speaker 00:
I mean, you presented evidence.

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I probably, honestly, if it was a fact finder, I would have found in favor of your position.

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But what I'm struggling with is I'm not the fact finder, and I have to give substantial evidence.

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And did the board say enough by pointing at do?

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So why don't you focus on why do isn't sufficient for them to have concluded there was a reasonable expectation?

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Because I do think you provided a lot of evidence that people might have thought that bonding that substance to PTFE would be difficult.

[00:02:49] Speaker 03:
Sure, Your Honor.

[00:02:51] Speaker 03:
On the question of whether due provides sufficient evidence, we contend that it is not.

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And there are four main points we wanted to raise.

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The first being that due, like all of the references in the record, require the person of skill in the art to first choose from various embodiments and various disclosed materials and to choose actually non-preferred

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materials.

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For example, in DEW, while there is a list of various materials that can form each layer as well as adhesives, if you look at what DEW actually teaches and provides express disclosure of, it's of a metal underlying latticework used in a silicon adhesive to bond to a textile layer.

[00:03:46] Speaker 03:
The reference to polycarbonate urethane adhesive is a one-line sentence.

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The reference to PTFE is very brief, and it does not explore that.

[00:03:58] Speaker 01:
But it refers to Pinch Up, which is more than just one line.

[00:04:05] Speaker 03:
That's correct, Your Honor.

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We submit that if, in fact, Do had provided a reasonable expectation of success that polycarbonate urethane

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could be used in this situation, the reference would have disclosed its use for that purpose.

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And another important point we wanted to raise, Your Honors, is that you have to take this in context.

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And the context is provided by our declarations and the extrinsic evidence we submitted.

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At the time of this invention, and even still today, the context and the understanding of a person of skill in the art is that this type of bonding to this type of a substance

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is not expected to work.

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And while there is a mention in due of the polycarbonate urethane adhesive, there's no working example, there's no detailed discussion in due or any of the other references that would have informed a person of skill in the art that this common understanding, which even though the patent office has agreed was the common understanding that this type of a substance is difficult to bond,

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that this would have worked in this circumstance.

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And again, if you look at the other references of record, you have Schmidt, which mentions adhesive, again in passing, and teaches that the bonding can be by essentially melting a textile layer to the underlying layer.

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You have the Schoenard reference, which again teaches a metal stent as the preferred embodiment.

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and a silicon adhesive.

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And so all of this together, we submit that it's not sufficient evidence to show that a person of skill in the art would have had a reasonable expectation of success.

[00:05:58] Speaker 01:
You have quite broad claims.

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You're not claiming a specific material with a specific

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bonding agents, you've got very broad claims.

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And you start off with Schmidt, which discloses a prosthesis and show an odd.

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And then you've got Dew, and Dew does disclose the binding agent.

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It brings in Pinchik as well.

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And so why isn't that substantial evidence?

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Judge Moore said we're not fact-finding.

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We're reviewing more decisions.

[00:06:41] Speaker 03:
First, I would like to address your question about or your comment about the breadth of our claims.

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Our claims are actually pretty narrow, we believe.

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Claim one, for example, defines the second layer as being expanded polytetrafluoroethylene.

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And claim one also defines the bonding agent as being

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a very specific type of polycarbonate urethane.

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So our claims are fairly narrow, and we are trying to claim this specific combination of materials that is nowhere combined in this manner in the prior art.

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And as discussed in the briefing, we have a second grounds that we believe should be

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that the rejection should be reversed for, and that is that the prior art does not enable the claimed invention.

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And even though this is an obviousness case, the law still requires that the prior art enable the claimed invention.

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It's not enough that the prior art enables itself.

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It's that the prior art enables the claimed invention.

[00:08:01] Speaker 01:
Well, the application

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including application for the claimed invention, it is that which must enable itself.

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And if it takes a component which is reasonably part of the prior art, the prior art doesn't need to have been enabled.

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I agree with you that references used in obviousness rejection do not need to be individually

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They do not need to enable themselves to be applicable prior art.

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However, the law, we believe, is clear that the prior art has to enable the claimed invention.

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And here we believe that that enablement is lacking.

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If the prior art enables the claimed invention, the prior art probably anticipates the claimed invention.

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It may, but again, there could be multiple references that together

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The question is whether the multiple references collectively enable the claimed invention.

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And that's, that's the relevant inquiry here.

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And the enablement inquiry is, as your honors certainly know, is a de novo review.

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So here we have a little more deference to the, to the standard of, on the standard of review.

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And the four primary points we want to make as to why we believe that the,

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that the prior act does not enable the claimed invention is that first there's considerable and largely unrebutted evidence that it was known to be difficult to bond PTFE to anything.

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Our specification discusses this.

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The declarations discuss this point.

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The extrinsic evidence we presented also discusses this.

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And the examiner and the board agreed with that general statement.

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The examiner even went so far as to say that

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He agreed it wasn't expected that PTFE could bond without a surface treatment.

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But then there's no subsequent discussion of what surface treatments he envisioned.

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Second point, there's not a single working example where expanded polytetrafluoroethylene is bonded to a textile using an adhesive, even though this was an exceptionally crowded field.

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Virtually all of the references that are applied by the patent office mention

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PTFE, yet none of them provide any example where it's actually bonded.

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This was something that was at the forefront of everyone's mind at this time, yet no one was able to get it to work.

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The third point is there's not even an express mention of an expanded polychetrafluoroethylene layer, a textile layer, and a polycarbonate adhesive layer together.

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There are mentions of these elements individually, but you would be required to pick and choose from each of them in order to arrive at that combination.

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And finally, the final point is that we have expert testimony that the lack of bonding conditions such as a solvent and working examples in the prior art creates a situation where undue experimentation is required.

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The board addressed our enablement argument

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largely by leaning heavily on what a person of skill in the art would have known.

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However, as this court's Genentech case, which we discussed in the blue brief, mentions and discusses, you cannot rely on what one of skill in the art would have done if there's no evidence of it.

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And what's notable about that case, which has a lot of similarities with this case, is that in that case, the court

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said that if it was within the skill of a person of ordinary skill in the art to enable and make and use the claimed invention, it would have been disclosed in the usual detail.

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And the opinion makes the case that patent practitioners are not loathe to include examples when they know how to make and use something.

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And that case was on a preliminary injunction.

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And this court actually reversed the preliminary injunction and found as a matter of law that the underlying patent was not enabled.

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We submit here that if it was within the skill of a person of skill in the art to take the disclosure of due or any of the other references and get a polycarbonate urethane to bond polytetrafluoroethylene to a textile, this would have been disclosed somewhere

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other than in a single sentence and due in a non-preferred embodiment.

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Unless there's other questions, I'll save my time for rebuttal.

[00:13:07] Speaker 02:
Let's save your rebuttal time, and let's hear from the office.

[00:13:11] Speaker 02:
Thank you, Mr. Clark.

[00:13:16] Speaker 02:
Ms.

[00:13:16] Speaker 02:
Lateef.

[00:13:17] Speaker 04:
May it please the court?

[00:13:18] Speaker 04:
Good morning, Your Honors.

[00:13:19] Speaker 04:
Monica Lateef for the United States Pet and Trademark Office.

[00:13:24] Speaker 04:
So Chancellor Evidence supports the board's findings that Maquette's claims are obvious over Schmidt and Dew and Chouinard and Dew.

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And the combinations provide a reasonable expectation of success that polycarbonate urethane would bind ePTFE with a textile layer.

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The argument that Maquette, I think I'm saying properly, apologize if I'm not, is arguing that there is no reasonable expectation of success

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is not the case.

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They have not pointed to reversible error in the board's decision.

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The reference due, the secondary reference, provides guidance as to how a person of ordinary skill in the art would use polycarbonate urethane to bond a PTFE layer with a textile.

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And then you look to the primary references, either Schmidt or Chouinard, to see that those references taught

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that there is an adhesive that is used to bond a ePTF layer with a textile.

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They're silent as to the type of adhesive that is used, but that is where DEW comes in.

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And this notion that DEW doesn't give examples, DEW discloses that you can use silicone, but it does say you can use polycarbonate urethane as an alternative.

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And a part of that reference is a reference for all that it teaches.

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The fact that a person of ordinary skill in the art couldn't look at Dew and realize if they're saying you can use polycarbonate urethane as an adhesive and understand that they can swap out the silicon, that doesn't make any sense.

[00:15:03] Speaker 04:
A person of ordinary skill in the art and the board found would be able to look to Dew and understand that.

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And in fact, Dew also talks about the fact that you would take a solvent and you would combine it with the adhesive and then you could spray the PTFE layer.

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And the board found that a person of Orneal Skinly Art would have the requisite skill to understand that and be able to do so.

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With respect to the enablement argument, I just want to be clear what the office is arguing is that when it comes to enablement and obviousness, a piece of prior art

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itself is not required when there's an obvious rejection.

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You have to do the combination, as Judge Laurie was discussing.

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And in addition to that, prior art is presumptively enabled, and it's up to McKay to prove that there was not enablement here.

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And the board said four times in its decision that they looked at all of the exhibits that were provided, that they considered both of the declarations

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And that based on the expressed disclosure in due, McKay did not meet its burden of establishing that there was no enablement.

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So basically, when you look at the references and you combine them together, there is substantial evidence that McKay's invention is obvious.

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And I respectfully ask that the court affirm the board's decision.

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And if there are no questions, I will yield my time.

[00:16:41] Speaker 02:
Thank you.

[00:16:47] Speaker 02:
Mr. Clark, tell us again how you get around the reference.

[00:16:55] Speaker 03:
The due reference, as we mentioned, has a very limited disclosure.

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I wouldn't even call it a disclosure.

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I'd call it a mention of polycarbonate urethane, which is the specific adhesive that we have disclosed.

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So on the idea that DO expressly discloses the use of polycarbonate urethane to bond PTFE, we would submit that it does not expressly disclose that, that you have to pick and choose from among various different materials to arrive at that combination.

[00:17:28] Speaker 03:
On the enablement aspect, I think the argument was that- When I look later in DO, it mentions PTFE.

[00:17:37] Speaker 03:
I'm sorry, Your Honor.

[00:17:39] Speaker 01:
Dew does mention not only the polycarbonate urethanes, but also PTFE.

[00:17:50] Speaker 01:
So it does disclose the fabric.

[00:17:54] Speaker 03:
That's correct.

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Our claim is actually directed to expanded polytetrafluoroethylene, which is a little bit different.

[00:18:00] Speaker 03:
I think Dew discusses

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strands of PTFE that can be essentially wound together or formed into a lattice work, whereas expanded polytetrafluoroethylene is more of a sheet that's been stretched.

[00:18:16] Speaker 01:
So if it's stretched, there's more opportunity for bonding, and that's why it works?

[00:18:22] Speaker 03:
That's possibly part of why it works.

[00:18:25] Speaker 03:
More of why it works, we believe, is that the specific solvent and the bonding conditions we were able to discover

[00:18:33] Speaker 01:
those provided with the working... So you're arguing the distinction between expanded PTFE and PTFE.

[00:18:41] Speaker 03:
I'm sorry?

[00:18:42] Speaker 01:
You're arguing the distinction between expanded PTFE and PTFE.

[00:18:48] Speaker 03:
That is one distinction with the due reference.

[00:18:50] Speaker 03:
I agree with that.

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On the enablement argument, the Patent Office believes that due provides guidance as to how to use

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polycarbonate urethane to bond to PTFE.

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And we submit that it does not.

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It provides working examples and guidance on how to use a silicon material, but it does not translate to how to use a polycarbonate urethane.

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And our expert disclosure specifically addressed to and said it does not provide the necessary bonding conditions and other

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necessary reaction conditions.

[00:19:30] Speaker 01:
Is there evidence showing that expanded PTFE works with the polytabinic urethane whereas unexpanded PTFE does not?

[00:19:45] Speaker 03:
I don't believe we have that evidence.

[00:19:47] Speaker 03:
I also don't think there's evidence that either of them works with

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that polycarbonate urethane works with either expanded or non-expanded.

[00:19:55] Speaker 01:
Well, you're claiming the latter.

[00:19:58] Speaker 03:
We are.

[00:19:58] Speaker 03:
That's correct.

[00:19:59] Speaker 01:
And you don't have evidence that that works?

[00:20:01] Speaker 03:
Oh, we have evidence that it works in our application, but we didn't.

[00:20:05] Speaker 03:
There's not a compare between the two, I don't believe.

[00:20:11] Speaker 02:
Any more questions, Mr. Claire?

[00:20:13] Speaker 02:
More questions?

[00:20:15] Speaker 02:
Great.

[00:20:15] Speaker 00:
Thank you.

[00:20:16] Speaker 02:
We'll take on your advisement.

[00:20:19] Speaker 02:
Thank you both.