[00:00:00] Speaker 00:
The first case is C.R.

[00:00:01] Speaker 00:
Bard versus Angio Dynamics, 2023-2056.

[00:00:06] Speaker 00:
Ms.

[00:00:07] Speaker 00:
Maynard.

[00:00:11] Speaker 03:
Thank you, Judge Glory, and may it please the court, Deanne Maynard for Bard.

[00:00:14] Speaker 03:
I'd like to reserve three minutes for rebuttal.

[00:00:18] Speaker 03:
The judgment can be reversed on procedure alone.

[00:00:21] Speaker 03:
On 101, this court already held these very patent claims eligible on indefiniteness,

[00:00:28] Speaker 03:
No party raised that issue, so it could not be a proper basis for JMAW.

[00:00:34] Speaker 03:
And on anticipation, this court already held that a reasonable jury could reject angiodynamics as defense.

[00:00:42] Speaker 03:
A reasonable jury did so, and that should have been the end of the matter.

[00:00:46] Speaker 03:
Good point.

[00:00:49] Speaker 00:
We may sympathize with you and even fine for you on 101.

[00:00:57] Speaker 00:
indefiniteness for reasons you've stated, but anticipation is another matter.

[00:01:04] Speaker 00:
We held in the last case that the content of the information conveyed by the radiographic matter is printed matter and entitled to no patentable weight.

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And the district court

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That being the case, the court said the trial record leaves no room for a reasonable jury to conclude, but that the several prior audit approaches each anticipate the claims.

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And it repeated.

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Because review of the trial record reveals that the jury had no sufficient basis to reject that Bard's adult titanium PortaCath and Portex ports, Anticipate the claims.

[00:01:56] Speaker 00:
So putting aside the radiological markers, it doesn't seem to be much left.

[00:02:05] Speaker 03:
Well, I disagree with many parts of that, Your Honor.

[00:02:07] Speaker 03:
So on the first appeal, this court

[00:02:10] Speaker 03:
address the printed matter issue, as you say.

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And it held, as you said, that the information conveyed by the radiographic marker is not entitled to patentable weight.

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But this court also held that the radiographic marker itself and the means that are claimed, the identifiable means, are entitled to patentable weight.

[00:02:30] Speaker 03:
And at pages 1384 to 85, the court said, this means that the claims require two things.

[00:02:38] Speaker 03:
that the features are radiographically discernible, and two, that they distinguish or identify the device or its functionality.

[00:02:46] Speaker 03:
So what this court held was printed matter is what it told you.

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In other words, that it could take the flow rate and the pressure.

[00:02:55] Speaker 03:
But the fact that it needed to have a radiographic marker that identified something about the port or its functionality.

[00:03:02] Speaker 00:
You're saying that the marker is different from what it conveys?

[00:03:06] Speaker 03:
Yes, Your Honor, because it's a radiographic marker.

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And so it needs to both, as this court said at 1384 and 85, and I'm quoting, it needs to be radiographically discernible.

[00:03:16] Speaker 03:
That's a quote.

[00:03:18] Speaker 03:
It means distinguish or identify the device or its functionality.

[00:03:22] Speaker 02:
Well, there's actually a few different ways we could read this last sentence of the opinion.

[00:03:26] Speaker 02:
And obviously, it'll be up to the court to decide.

[00:03:30] Speaker 02:
But what this sentence is doing is summarizing the evidence that you presented on your side, that maybe the features were not radiographically discernible.

[00:03:43] Speaker 02:
Maybe these features could not be used to identify or distinguish the device.

[00:03:51] Speaker 02:
These features don't communicate its functionality.

[00:03:56] Speaker 02:
It's not necessarily saying that all three of those things are required to meet the claim limitation.

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It's just that this was the evidence you presented.

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And overall, the conflicting evidence requires us to send it back.

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So for example, it could not be that we demanded that the features, the radiographic features somehow communicate the functionality of the port.

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That's the very printed matter that we basically struck from the claim as being nothing more than unpatentable printed matter.

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So there's questions here as to how far we should go in terms of

[00:04:37] Speaker 02:
expectations on what needed to be proved.

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But beyond all that, this record is different than the record that existed back in 2020 when we issued this decision.

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We now have stipulations here from your side saying that, yes, these ports were all discernible, these titanium ports via x-ray.

[00:05:02] Speaker 02:
We also have, I believe,

[00:05:04] Speaker 02:
concessions from Dr. Johnson, your expert, saying, yes, all these different attributes of, for example, the ATP port are in fact discernible by expert.

[00:05:17] Speaker 02:
You could see them.

[00:05:19] Speaker 02:
So because we have a different record, it's not so simple to just transport a statement that there was once upon a time genuine issues of internal fact on record one into what now is a modified bulked up record two.

[00:05:36] Speaker 03:
So two points about that.

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One on the meaning of this court's first opinion.

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So at page 1382, this court said, we first addressed the printed matter issue.

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And then after removing the printed matter,

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we address whether or not there's a genuine dispute of material fact for trial.

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And it held that there was on anticipation.

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And as our reply brief shows at pages 14 to 17, the evidence that they showed in the trial is materially the same as the evidence they showed you the first time when you concluded there was a dispute of fact.

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That's one point.

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The second point is

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Their supposed concessions on this feature, which are on page 43 of the red brief, they point to three, the three that you just identified.

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Those are neither new nor concessions of the sort that would require a jury to conclude.

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that they had established their burden by clear and convincing evidence, which is the only way that the JMAW can be sustained, that a jury could only reasonably conclude that the markers that they have are perceivable and serve to identify something about the port.

[00:06:43] Speaker 03:
So starting with the first one, they say, as Your Honor said, that Bard stipulated that the titanium ports are visible on x-ray.

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One, Bard has never disputed that metal

[00:06:53] Speaker 03:
is visible on x-ray.

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The claims require more than that.

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They require a radiographic marker that tells you something about the port.

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That's the point of the invention is that once something's inside somebody's body,

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that the marker identifies something about the port.

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When we were here before, no one disputed that the means got, that the markers had to be shown, that there needed to be something communicated.

[00:07:17] Speaker 03:
Just what was communicated is the information that's printed matter that doesn't get patented away.

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And that's what this court held.

[00:07:25] Speaker 02:
But our summary said that there was conflicting evidence on whether the features of the port are even radiographically discernible.

[00:07:32] Speaker 02:
So I mean, you might feel like,

[00:07:35] Speaker 02:
The record already cleaned that up the first time around, but that was at least one of our bases for sending it back.

[00:07:44] Speaker 03:
And there was trial evidence from which a reasonable jury can conclude that they aren't radiographically discernible in any meaningful way.

[00:07:51] Speaker 03:
So they say that Bard's expert admitted that titanium port-shaped suture holes and other features are, quote, perceivable via x-ray.

[00:07:59] Speaker 03:
And they cite our expert, I think is what you're referring to, at A5965 to 66.

[00:08:04] Speaker 03:
But Dr. Johnson, the same expert, he merely agreed that on a high radiation x-ray, one not taken under conditions relevant to the patent claims, you could see ATPs, that's our adult titanium port, the fire airport, shape suture holes and stem.

[00:08:22] Speaker 03:
But he said that those weren't appropriate settings under which to consider the claims, because the claims, of course, require a radiographic marker that you can see once the plant's imported subcutaneously inside a patient.

[00:08:34] Speaker 03:
And so he talked about how he had taken that x-ray that they rely on for the adult titanium port RX for Dr. Johnson.

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He said he took it on a table with 40 times the radiation you would use.

[00:08:45] Speaker 02:
Did you do somewhere in your briefing where you said the concessions of A5965-66 have no relevance here because he was looking at the wrong x-ray?

[00:08:57] Speaker 03:
We say, in our blue brief, we say that the district court ignored the fact, ignored material flaws that we pointed out with their expert's testimony.

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And that's in the part where we address the radiographic markers.

[00:09:25] Speaker 03:
On page 53, Your Honor, the paragraph that starts plus, the district court ignored evidence identifying flaws in that expert's methodology.

[00:09:33] Speaker 03:
Bard's expert explained that angiodynamics' expert had relied on x-ray taken using non-clinical settings.

[00:09:40] Speaker 03:
And it states what I just said to you.

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He also went through, in that same discussion, he showed the jury, and this is like in the record, the pictures are at A25789 to 791.

[00:09:53] Speaker 03:
He showed the jury.

[00:09:55] Speaker 03:
x-rays that would be comparable to what it would look like.

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And he said from that, you can't tell anything about the ports.

[00:10:02] Speaker 03:
Because when they're in the body, sometimes they're turned askew.

[00:10:05] Speaker 03:
And so we did dispute in the trial, just as we had in the first appeal, that the x-rays were perceivable in a way that would allow you to tell anything about the port.

[00:10:13] Speaker 03:
And their expert conceded.

[00:10:15] Speaker 03:
So Dr. Johnson, as to the other two ports, their expert conceded on cross that

[00:10:23] Speaker 03:
While he could see them in the x-ray, they didn't serve as a marker of anything.

[00:10:27] Speaker 00:
You're on the weeds about what is really not patentably eligible.

[00:10:34] Speaker 03:
I'm in the weeds about patent eligibility, Your Honor?

[00:10:36] Speaker 00:
You're in the weeds about what is not patent eligible in a radiographic manner.

[00:10:43] Speaker 03:
Well, so I disagree with that.

[00:10:46] Speaker 03:
I think this Court's first opinion held that the radiographic marker, the claims require, like just to go through one of the claims, the claims require an assembly for identifying a power in dumb on A107 and claim one, the independent claim of 417.

[00:11:04] Speaker 03:
an assembly for identifying a power injectable vascular access port comprising a first identifiable feature incorporated into the access port perceivable.

[00:11:13] Speaker 03:
So the printed matter is later.

[00:11:14] Speaker 03:
The printed matter limitation, as the jury was told, is the limitation that tells you it's suitable for accommodating a pressure within the cavity.

[00:11:22] Speaker 03:
The information that's conveyed

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And that's consistent with this court's precedent.

[00:11:25] Speaker 03:
You don't excise printed matter from the claims.

[00:11:28] Speaker 03:
The means still get patentable weight.

[00:11:31] Speaker 03:
And I think on the first appeal, Your Honor, that was uncontested.

[00:11:34] Speaker 03:
They did not contest that it was just the information that they pointed to.

[00:11:38] Speaker 03:
What did you say gets patentable weight?

[00:11:40] Speaker 03:
The means, M-E-A-N-S, the radiographic marker itself, which serves to identify something about the court.

[00:11:47] Speaker 02:
The radiographic material.

[00:11:48] Speaker 02:
which is perceivable through an x-ray, that is a structural element of the claim.

[00:11:56] Speaker 02:
But after that, anything else that's trying to communicate something through that radiographic material, that's going to matter.

[00:12:06] Speaker 03:
I disagree, Your Honor.

[00:12:07] Speaker 03:
It's the message, the message itself.

[00:12:09] Speaker 03:
Like, I am blue.

[00:12:11] Speaker 03:
What it tells you, I can stand a speed of 1 milliliter per second.

[00:12:17] Speaker 03:
I can expand the speed at 35.

[00:12:18] Speaker 00:
Claim four says, the radiographic marker is a selector from a group consisting of an observable pattern, a symbol, a type of graphical character, and a DCM and combinations thereof.

[00:12:34] Speaker 00:
Not concrete.

[00:12:35] Speaker 03:
Well, those are the means of a radiographic marker.

[00:12:37] Speaker 03:
So it's not just a symbol, Your Honor.

[00:12:39] Speaker 03:
It's a radiographic.

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It's a radiographic marker in the shape of a symbol.

[00:12:43] Speaker 03:
So even if you thought for some reason that the prior art wasn't distinguishable on identifiable feature, the jury was entitled to reject the argument that the prior arts were power injectable within the meaning of the claims.

[00:12:56] Speaker 03:
And so they have to win on both.

[00:12:58] Speaker 03:
Because the prior art, they have to show both radiographically

[00:13:02] Speaker 03:
a radiographic marker, which we don't think they did.

[00:13:05] Speaker 03:
And we think you should resolve that on procedure alone.

[00:13:07] Speaker 03:
They also have to show that the claims could meet the power injectability, that part out courts could meet the power injectability limitations of the claims.

[00:13:16] Speaker 03:
And a reasonable jury could conclude they didn't do so.

[00:13:19] Speaker 03:
One.

[00:13:20] Speaker 00:
You wanted to save some bottle time.

[00:13:23] Speaker 00:
You want to keep going or save it?

[00:13:26] Speaker 03:
Can I just say one minute about that?

[00:13:28] Speaker 03:
Because I want to, this is a separate reason for us to prevail.

[00:13:32] Speaker 03:
Thank you, Your Honor.

[00:13:35] Speaker 03:
So their own documents admit that their report's not power-injectable.

[00:13:40] Speaker 03:
The evidence showed that changes were made to all three of these prior reports for them to be power-injectable, that persons of skill and the art did not consider them power-injectable.

[00:13:51] Speaker 03:
And that's enough for a reasonable jury to reject that they proved by clear and convincing evidence that there was anticipation.

[00:13:58] Speaker 00:
Thank you, Your Honor.

[00:13:59] Speaker 00:
I will give you three minutes for a bottle.

[00:14:01] Speaker 03:
Thank you, Judge Laurie.

[00:14:02] Speaker 00:
Ms.

[00:14:03] Speaker 00:
Tully.

[00:14:12] Speaker 04:
Thank you, Your Honor.

[00:14:13] Speaker 04:
May it please the court, Danielle Tully for Angiodynamics.

[00:14:17] Speaker 04:
This case comes down to the claims in the construction.

[00:14:19] Speaker 04:
Under the construction that the jury was instructed to apply, clear and convincing evidence established that the asserted claims are anticipated under 102.

[00:14:28] Speaker 04:
Throughout the 2022 trial, Bard twisted the construction to evade the prior art.

[00:14:33] Speaker 04:
And the only evidence it now cites in support of the verdict ignores the claims, the specification, and the construction altogether.

[00:14:42] Speaker 04:
But neither are relevant evidence based on unclaimed features or conclusory statements from its experts that they don't see a limitation in the prior art is substantial evidence that can support the jury's verdict.

[00:14:53] Speaker 04:
And while Jamal should be sparingly granted, this is the exception where it's warranted.

[00:14:59] Speaker 02:
If there's conflicting evidence, then we have to go with the jury.

[00:15:03] Speaker 02:
Is that right?

[00:15:04] Speaker 04:
I would agree with you, Your Honor, except here there was no conflicting evidence.

[00:15:08] Speaker 04:
This is not the same record that this court had on summary judgment prior.

[00:15:13] Speaker 04:
Additional evidence came in, and I believe as Your Honor.

[00:15:17] Speaker 01:
The experts were in agreement, right?

[00:15:19] Speaker 04:
The experts were in agreement across the board at the 2022 trial that the prior reports

[00:15:26] Speaker 04:
were visible on x-ray, which is all that the claim construction requires for the radiographic feature.

[00:15:32] Speaker 04:
In 2020, when this case was before the court previously, this court noted that there was largely undisputed evidence that the prior art courts were already structured for power injection.

[00:15:42] Speaker 04:
That same evidence and more came in at the 2022 trial.

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With respect, and 2020 when this court had the case, this court noted that what was left in dispute was that the experts disagreed whether or not those courts also had radiographic markers.

[00:16:00] Speaker 04:
When this case went back down to trial, there was no longer a dispute.

[00:16:04] Speaker 04:
That dispute went away.

[00:16:05] Speaker 04:
And after that, there was nothing that the jury could have based its verdict on.

[00:16:10] Speaker 04:
So as Judge Chen pointed out, we have, at APPX 5241,

[00:16:15] Speaker 04:
Bard stipulated at trial that titanium vascular access ports were radiographically visible on x-ray before April 27, 2004.

[00:16:26] Speaker 04:
At APPX 5965 to 66, Johnson testified that ATP's holes, shape, and outlet stem are radiographically visible.

[00:16:35] Speaker 04:
Ms.

[00:16:36] Speaker 04:
Maynard raised the x-ray settings that that x-ray was taken at.

[00:16:41] Speaker 04:
The claims don't require any specific x-ray settings.

[00:16:43] Speaker 04:
They're silent to that.

[00:16:44] Speaker 04:
They simply require that it's visible on x-ray.

[00:16:48] Speaker 04:
That was shown at trial, and Dr. Johnson agreed as much.

[00:16:53] Speaker 04:
Dr. Clark testified that shape is a radiographic marker that identifies the fork.

[00:16:58] Speaker 04:
And that's at APPX 4889 to 90, APPX 4905, and APPX 4908 to 12.

[00:17:07] Speaker 04:
Dr. Clark also testified that the very shape identifiers that angiodynamics pointed to as meeting the radiographic marker limitation would have infringed.

[00:17:21] Speaker 04:
And that's specifically at APPX 5061.

[00:17:25] Speaker 04:
He said that a square shape could infringe.

[00:17:27] Speaker 04:
And at APPX 5061, he also said that a notch shape could infringe.

[00:17:34] Speaker 04:
It's undisputed that PortaCap had a square shape,

[00:17:37] Speaker 04:
and the vortex port had a knot shape.

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And it is axiomatic, Your Honors, that that which would infringe if later must anticipate if earlier.

[00:17:45] Speaker 04:
On Dr. Clark's concession alone, there should be no dispute about the radiographic marker.

[00:17:52] Speaker 04:
On the question of whether or not the ports were power injectable, we don't think that there's any dispute whether or not the ports are power injectable.

[00:18:00] Speaker 04:
Ms.

[00:18:00] Speaker 04:
Maynard referenced some documents of angiodynamics that said that the vortex port was not power injectable.

[00:18:08] Speaker 04:
When those documents said that the vortex port was not power injectable, that document was referring to FDA indication.

[00:18:13] Speaker 04:
That document was not referring to whether or not those ports were structured for power injection as per this port's claims instruction, which means that it must be suitable for flowing a fluid at 1 milliliter per second and suitable as well for withstanding cavity pressures at 35 psi.

[00:18:30] Speaker 04:
Those documents do not apply to claim construction, and they are not relevant evidence that could support the jury's decision.

[00:18:38] Speaker 04:
And your honor, to the extent that Bard would contend that this court somehow changed the claim construction of the radiographic marker with its 2020 opinion, we would strongly disagree.

[00:18:50] Speaker 04:
At no point did this court change the claim construction of the radiographic marker to be anything other than perceivable via x-ray.

[00:18:58] Speaker 04:
And Bard certainly didn't ask for it to change the construction of the radiographic marker.

[00:19:03] Speaker 02:
To what extent does an identifiable radiographic marker need to specifically identify a particular port versus other ports?

[00:19:14] Speaker 02:
I mean, the word identify, identifiable, it could mean a few different things.

[00:19:21] Speaker 02:
One is, is it seeable?

[00:19:23] Speaker 02:
Is it perceivable?

[00:19:26] Speaker 02:
does it identify in the sense that it distinguishes it from every and any other type of port that might be installed in a patient?

[00:19:36] Speaker 04:
And the construction here, Your Honor, is perceivable.

[00:19:38] Speaker 04:
Because if it were to be that it needs to distinguish it from every other port that was ever

[00:19:44] Speaker 04:
implanted in a patient, as the district court recognized, that would render the claim limitation indefinite.

[00:19:50] Speaker 04:
Because it would depend on an unknowable standard of comparing it to every prior art court that ever existed.

[00:19:57] Speaker 02:
And only on the very- Your Dr. Vogelzang seemed to think that all three of the prior art courts are, in fact.

[00:20:04] Speaker 02:
The features that are perceivable are, in fact, so distinctive that you can identify that

[00:20:13] Speaker 02:
a given port is an ATP port or a PAC port or a Vortex port based on their shape and other features that you can see via x-ray?

[00:20:22] Speaker 04:
That's correct, Your Honor, and that's what Dr. Vogelsang described as Aunt Minnie.

[00:20:25] Speaker 04:
He knows his Aunt Minnie when he sees her because he knows what his Aunt Minnie looks like.

[00:20:30] Speaker 04:
So once he knows what ATP looks like, once he knows what portacat looks like, that portacat has a square shape and four suture holes situated up in the corner.

[00:20:38] Speaker 04:
Vortex has the characteristic knot shape.

[00:20:41] Speaker 04:
and the tangential outlet stem.

[00:20:43] Speaker 04:
Bard's ATP port had two orientation holes and was generally round and larger than the other ports.

[00:20:49] Speaker 04:
Once you know that that's what the ports look like, that becomes the identifiable feature.

[00:20:55] Speaker 04:
And the patent says as much.

[00:20:57] Speaker 04:
At APPX 105 and column 25, if we take a look at the bottom of column 25, in one embodiment, at least one physical attribute

[00:21:11] Speaker 04:
e.g.

[00:21:11] Speaker 04:
size, shape, et cetera, of an access port may identify the access port as suitable for power injection or may identify a maximum flow rate or pressure that may be safely accommodated by the access port.

[00:21:25] Speaker 04:
The specification doesn't say that a radiographic marker needs to be added to the port.

[00:21:30] Speaker 04:
It doesn't say that a particular shape has to be the port.

[00:21:33] Speaker 04:
It certainly doesn't say that a unique shape has to identify the port.

[00:21:38] Speaker 04:
It says any shape, any physical attribute,

[00:21:41] Speaker 04:
And that's the way Bard claimed this.

[00:21:42] Speaker 04:
And that's what the claims say.

[00:21:45] Speaker 04:
And by arguing anything other than that, Bard's experts weren't arguing about the scope and content of the prior art.

[00:21:52] Speaker 04:
They were arguing about the scope and content of these claims.

[00:21:56] Speaker 04:
And they were impermissibly changing the claim construction.

[00:21:59] Speaker 04:
And that is why all of the evidence that Bard now points to cannot be evidence that could support the jury's decision, because it's simply not relevant.

[00:22:08] Speaker 00:
Go ahead.

[00:22:11] Speaker 00:
these portal cap devices were cited to the examiner and considered by the examiner?

[00:22:17] Speaker 04:
So BARD actually contends in its brief that these ports were before the examiner.

[00:22:25] Speaker 04:
But what was before the examiner were the IFUs for these documents, the instructions for these.

[00:22:29] Speaker 00:
When I look at the patent to see what's before the examiner, I see hundreds and hundreds of references.

[00:22:36] Speaker 00:
Citing references is supposed to be for the purpose of pointing out

[00:22:41] Speaker 00:
what may be relevant to patentability.

[00:22:45] Speaker 00:
Hundreds, and I see a couple of PortaCat references, and so you don't know whether those specific ones, I mean this is an abuse of the patent system frankly, which is not to a client, it's opposing client.

[00:22:59] Speaker 00:
But do you know whether these are the references?

[00:23:02] Speaker 04:
So, Your Honor, what the Patent Office didn't have, and this actually was a theme throughout the entire trial, what the Patent Office didn't have was the independent testing that was submitted to the FDA.

[00:23:12] Speaker 04:
So Bard, Angio Dynamics, and Smith's Medical, the creator of Portica, all independently tested their ports and proved to the FDA that those ports were suitable for power injection, so that they could get an FDA indication for power injection.

[00:23:29] Speaker 04:
And while the patent office may have had IFUs, instructions for use, on the prior art ports themselves that didn't say that they were power injectable, they didn't have that underlying testing.

[00:23:40] Speaker 04:
Because that underlying testing is not publicly available.

[00:23:43] Speaker 04:
But that's what shows that the ports are structurally capable for power injection.

[00:23:48] Speaker 04:
And that's the only evidence that matters here.

[00:23:51] Speaker 04:
And that evidence cannot be contradicted by

[00:23:54] Speaker 04:
by conclusory statements of experts that they didn't think that those ports were safe to use because they were not FDA cleared for power injection.

[00:24:02] Speaker 02:
Is it true that some of Bard's ATP ports that were tested failed the power injectability limitations?

[00:24:11] Speaker 04:
Your Honor, there were certain ports that were built closer to manufacturing constraints that the power port eventually had.

[00:24:21] Speaker 04:
So that's how Bard's inventor, Dr. Kelly Powers, actually determined what the structure for the, what the tolerances for the power port that was eventually launched needed to be.

[00:24:34] Speaker 04:
But that's just manufacturing tolerances.

[00:24:36] Speaker 04:
There were definitely ATP ports that passed power injection.

[00:24:40] Speaker 04:
In fact, Bard told the FDA as much.

[00:24:42] Speaker 04:
They power injected 30 ATP ports 36 times at the claimed pressures and flow rates and proved to the FDA that the ATP ports were already structured for power injection.

[00:24:54] Speaker 04:
That there were some fringe cases where ports would sometimes fail, not even necessarily on the first or second time of use, but on multiple times of use doesn't mean that

[00:25:05] Speaker 04:
But ATP port itself was not power injectable.

[00:25:09] Speaker 01:
Did Bard dispute whether the prior art showed that these devices were capable of power injection?

[00:25:21] Speaker 04:
So when this case was before the court in 2020, Bard did not dispute that those ports are power injectable.

[00:25:28] Speaker 04:
That was not part of the summary judgment record.

[00:25:30] Speaker 01:
It doesn't matter if they're FDA approved or not, right?

[00:25:34] Speaker 04:
It does not matter for purposes of the claim construction.

[00:25:36] Speaker 04:
And in fact, the judge actually instructed the jury when giving the jury instructions that FDA indication was not part of the claims.

[00:25:45] Speaker 04:
That the only thing that mattered to prove that a port was structured for power injection was that it met the structural capabilities of being able to be capable of withstanding fluid flow rates of 1 milliliter per second and 35 PSI.

[00:25:58] Speaker 02:
This case is already settled.

[00:26:00] Speaker 04:
This case has settled, Judge Chen.

[00:26:03] Speaker 01:
So are all the other arguments, are they all waived?

[00:26:10] Speaker 01:
We don't have to look at them?

[00:26:13] Speaker 04:
We don't believe, Your Honor, that the arguments are waived.

[00:26:16] Speaker 04:
Angiodynamics has not waived them.

[00:26:18] Speaker 04:
Angiodynamics, as appellee, does not have the ability to dismiss this appeal.

[00:26:22] Speaker 04:
Bard has to dismiss this appeal.

[00:26:25] Speaker 04:
So there are still live disputes before the court.

[00:26:28] Speaker 04:
And so while the party's independent agreement may have settled other aspects of this case, the private party's agreement can't change the federal rules of appellate procedure.

[00:26:39] Speaker 04:
So unless Bard dismisses this appeal, it is still before this court.

[00:26:45] Speaker 02:
So to complete the settlement, using the court as a tool, basically, to figure out whether money should be transferred.

[00:26:54] Speaker 04:
Bard has not yet dismissed this appeal, Your Honor.

[00:26:58] Speaker 04:
But, Your Honor, we do believe that the court need not look beyond the 102 ruling in the J-Mall in order to decide this case.

[00:27:10] Speaker 04:
As an alternative ground, the court did raise 101 and 112 in its opinion.

[00:27:17] Speaker 04:
But that's based on an alternative construction that's not before this court.

[00:27:20] Speaker 04:
We believe that the construction that was charged to the jury, where a power-injectable port

[00:27:28] Speaker 04:
was determined based on whether it was structurally capable of withstanding the claim fluid flow rates and pressures is what controls here.

[00:27:36] Speaker 04:
And where the radiographic marker simply needs to be perceivable via x-ray is what controls here.

[00:27:42] Speaker 04:
We don't think the court needs to reach 101 or 112 if its size is case on 102.

[00:27:48] Speaker 04:
And unless the panel has any further questions for me.

[00:27:52] Speaker 00:
Thank you, counsel.

[00:27:54] Speaker 00:
Ms.

[00:27:54] Speaker 00:
Maynard has a little time.

[00:27:58] Speaker 00:
And let me ask you, were these Porticath references buried in these hundreds of prior art?

[00:28:06] Speaker 00:
Are they the actual pieces of prior art that have been at issue here?

[00:28:13] Speaker 03:
So I don't know the answer to that standing here, Your Honor, so I don't want to misrepresent.

[00:28:19] Speaker 03:
I'm happy to supplement if you would like.

[00:28:21] Speaker 03:
But all the facts that counsel just attested to, this was her closing argument.

[00:28:26] Speaker 03:
All of these facts are disputed.

[00:28:28] Speaker 03:
I'll start with the power injectability.

[00:28:30] Speaker 03:
So it's not just documents.

[00:28:34] Speaker 03:
So on Vortex, Smith, who was an engineer, he admitted that extensive changes were required to make Vortex power injectable.

[00:28:42] Speaker 03:
That's at A5519 to 20.

[00:28:46] Speaker 03:
He testified that because of corporate restructuring, they didn't have all the documents.

[00:28:50] Speaker 03:
They had to scrap their program and start over, and they rebranded it as the SmartPort.

[00:28:54] Speaker 03:
And they changed at least the outlet stem and the port dimensions for the septum compression.

[00:28:59] Speaker 03:
That is a chunk of the port.

[00:29:01] Speaker 03:
So the vortex port, there was evidence before the jury that the vortex port, the structure of their new power port is different.

[00:29:08] Speaker 03:
It can't be prior art, or at least the jury was entitled to conclude that they had it.

[00:29:11] Speaker 01:
Did you dispute whether the prior art was capable of power injection?

[00:29:15] Speaker 03:
So capable of was a claim construction they saw, and it wasn't accepted by the court back in many years ago.

[00:29:23] Speaker 02:
The court- Is FDA indication required to meet the claim limitation for the power injection limitations?

[00:29:33] Speaker 03:
No, Your Honor.

[00:29:34] Speaker 03:
But the FDA evidence is relevant.

[00:29:37] Speaker 01:
But to her point- The claims just have to show that the courts were capable of power injection, correct?

[00:29:45] Speaker 03:
No, Your Honor.

[00:29:46] Speaker 03:
So they sought a capable of.

[00:29:47] Speaker 03:
That would make it broader.

[00:29:48] Speaker 03:
That might allow some things to be swept in, the prior that don't count.

[00:29:52] Speaker 03:
On A311, vascular access port was construed to be a port structured for power injection.

[00:30:00] Speaker 03:
It means that, as the jury was told, it has to be suitable for flowing fluid at a fluid flow rate of at least one milliliter per second and suitable for accommodating a pressure within the cavity of at least 35 PSI.

[00:30:11] Speaker 03:
On the Port-a-Cath port, none of the references showed that the port would withstand a cavity pressure of 35.

[00:30:19] Speaker 03:
That's A5845 to, that's Volga Zang, and then Johnson testified to the same thing around A5975.

[00:30:28] Speaker 03:
None of the prior art references showed it could do it.

[00:30:32] Speaker 03:
On our port,

[00:30:34] Speaker 03:
Our expert, they point to the 30, 30 ATPs.

[00:30:38] Speaker 03:
What the FDA documents show is that those ATPs were like what the PowerPoint was going to be like, not that they were identical in the claim construction way to the prior port.

[00:30:48] Speaker 03:
And in fact, our witness, Mr. Powers, the inventor, testified that changes were made, including to the manufacturing dimensions and the septum.

[00:30:56] Speaker 03:
And the only thing he agreed is that the same base had been used, but not the septum had been changed.

[00:31:01] Speaker 03:
And he drew a picture for the jury about the changes made.

[00:31:03] Speaker 02:
Are we talking about the ATP right now?

[00:31:05] Speaker 03:
Yes, Your Honor.

[00:31:06] Speaker 02:
Well, didn't your client Bard submit test results on the ATP to the FDA saying that it's power injectable?

[00:31:14] Speaker 02:
And your inventor sheets say that, for sure, they're power injectable?

[00:31:19] Speaker 02:
And Dr. Johnson admitted that at least some of the ATP ports were power injectable?

[00:31:24] Speaker 03:
So the testing, Your Honor, that was made- And then there was a stipulation that- So I'll address each one of those in turn, Your Honor, if you'd like.

[00:31:32] Speaker 03:
So the stipulation, it didn't talk about any particular court.

[00:31:36] Speaker 03:
It didn't name any particular court.

[00:31:38] Speaker 03:
It didn't talk about any time period.

[00:31:39] Speaker 03:
So we didn't agree that the ATP court at prior ATP court met the terms of the claims.

[00:31:45] Speaker 03:
The testing that she refers to, the 30, that's what I was talking about, the evidence shows

[00:31:51] Speaker 03:
And Powers testified that at least the, quote, septum was different, A4590.

[00:31:56] Speaker 03:
He's our inventor.

[00:31:57] Speaker 03:
And he distinguished that from the bases, which were hand-selected.

[00:32:00] Speaker 03:
But the septum was different.

[00:32:02] Speaker 03:
And all the FDA document says is the 30 are like the power port is going to be.

[00:32:07] Speaker 03:
They're like the new.

[00:32:09] Speaker 00:
It doesn't weigh over my time.

[00:32:13] Speaker 00:
Thank you for both counsel and the case is submitted.

[00:32:16] Speaker 03:
Thank you, Your Honor.