[00:00:00] Speaker 04:
Good morning.

[00:00:01] Speaker 04:
Our next case is CR Bard, Inc.

[00:00:03] Speaker 04:
versus Angiodynamics, Inc., case number 19-1756.

[00:00:07] Speaker 04:
Counselor Maynard, are you ready?

[00:00:15] Speaker 04:
Yes, Your Honor.

[00:00:16] Speaker 04:
OK.

[00:00:18] Speaker 04:
You may proceed.

[00:00:18] Speaker 04:
Now, let me make sure you reserve five minutes for rebuttal time, correct?

[00:00:23] Speaker 01:
Just three minutes, Judge Rainier, please.

[00:00:25] Speaker 01:
Three minutes, OK.

[00:00:26] Speaker 04:
You may proceed.

[00:00:28] Speaker 01:
Thank you very much.

[00:00:29] Speaker 01:
May it please the court?

[00:00:30] Speaker 01:
Diane Maynard for Bard.

[00:00:32] Speaker 01:
The district court dared in taking this case away from the jury at the end of Bard's infringement case in chief.

[00:00:39] Speaker 01:
Bard had entered ample evidence from what the regional jury could conclude that angiodynamics infringes all of the claims here.

[00:00:47] Speaker 01:
And the court prematurely, yes.

[00:00:49] Speaker 03:
Maynard, excuse me.

[00:00:50] Speaker 03:
This is Judge Schall here.

[00:00:53] Speaker 03:
Leaving aside for the moment infringement, I wanted to ask you a question

[00:01:00] Speaker 03:
Kind of a procedural question.

[00:01:02] Speaker 03:
Um, there are two issues here.

[00:01:04] Speaker 03:
Well, let me, let me back up and ask this way.

[00:01:08] Speaker 03:
Um, do you believe that the district court ruled that, uh, the claims that issue were ineligible for patenting under one Oh one, or do you believe that the district court held the claims were invalid?

[00:01:26] Speaker 03:
Cause they were obvious or anticipated.

[00:01:30] Speaker 01:
So you could not have, sorry, go ahead, Judge Hall.

[00:01:34] Speaker 03:
No, I'm just saying I'm puzzling a little bit over that, and I'd be interested to see if there was a 101 decision here in your view.

[00:01:41] Speaker 01:
I think that the judge did rule on 101, Your Honor.

[00:01:45] Speaker 01:
I think it could not have ruled on obviousness because that issue had not been raised at all yet at the trial.

[00:01:55] Speaker 01:
And indeed, there's even if there's not even was not ever a summary judgment motion on obviousness from the other side.

[00:02:01] Speaker 01:
So, obviousness can't be the basis for the decision.

[00:02:03] Speaker 01:
I don't think summary judgment on anticipation is the basis for the decision either because the courts at the end of the trial, when he ended the trial after our infringement case, the court said nothing about anticipation and the follow-up order didn't say he was granting any kind of summary judgment motion.

[00:02:22] Speaker 03:
Where do you see the judge ruling on 101?

[00:02:32] Speaker 03:
Because I looked at the, it came up at 25850 through 851.

[00:02:42] Speaker 03:
There seems to be a reference to the claims being abstract.

[00:02:48] Speaker 03:
But then in looking at the actual

[00:02:52] Speaker 03:
Ruling the written ruling that came down later.

[00:02:56] Speaker 01:
I didn't see any reference to 101 in there Well, I grant you that the that it's not a model of clarity your honor and You know if the court were to read this as simply a grant of Jamal of non-infringement and nothing else Well, that's clearly wrong out of an abundance of caution.

[00:03:17] Speaker 01:
We briefed all the issues it could possibly be and

[00:03:21] Speaker 01:
because we didn't want to have waived anything by not presenting it to this court, because the district court's ultimate order, it mentions ineligibility, it mentions in validity in the very ultimate order when it explained the Rule 54B judgment.

[00:03:37] Speaker 01:
But if the court wanted to read the court, sorry, go ahead, Your Honor.

[00:03:40] Speaker 03:
It's a little bit difficult when we can't see each other, so I apologize for the cutting in.

[00:03:48] Speaker 03:
At appendix page 18, it seemed to me that the judge at that page was suggesting that the claims were invalid.

[00:04:03] Speaker 03:
He references these other pieces of prior art, the Vortex SmartPort.

[00:04:10] Speaker 03:
And it seems to me that he was maybe saying, all right, the labeling or the printed matter didn't have patentable weight.

[00:04:18] Speaker 03:
So it didn't help you against these other things.

[00:04:21] Speaker 03:
It's a little bit unclear.

[00:04:23] Speaker 03:
But I read that 18 is sort of getting it possibly validity by anticipation or obviousness, although it wasn't stated.

[00:04:33] Speaker 01:
I don't think so.

[00:04:34] Speaker 01:
You can't be getting it obviousness for the reasons I say.

[00:04:37] Speaker 01:
And your dynamics never move for summary judgment on obviousness.

[00:04:40] Speaker 01:
And that was never mentioned at the trial.

[00:04:42] Speaker 01:
I mean, the questions you're asking, I think, sort of highlight the problem here with the procedural posture of this case.

[00:04:48] Speaker 01:
The district court prematurely ended the trial.

[00:04:51] Speaker 01:
There's not a basis to grant Jamal of non-infringement because we put on ample evidence that angiodynamics infringes.

[00:04:59] Speaker 01:
And angiodynamics had the burden by clearing convincing evidence of proving ineligibility or invalidity.

[00:05:05] Speaker 01:
And it hadn't even put on its case yet.

[00:05:07] Speaker 01:
And we hadn't had a chance to defend our patents.

[00:05:10] Speaker 01:
And I think that the court could just reverse on that procedural ground alone.

[00:05:17] Speaker 04:
This is the court... Go ahead, Judge Raina.

[00:05:25] Speaker 04:
Yeah, didn't the court rule sua sponte, you know, after the case in chief was presented, the court ruled sua sponte that the PANs were not, quote, eligible under any circumstances.

[00:05:41] Speaker 04:
And at that point... I think he...

[00:05:43] Speaker 01:
He did say that, Judge Ranier.

[00:05:45] Speaker 01:
So he brought up the... Andro Dynamics moved for J-Mall at the close of our evidence on infringement, only on non-infringement.

[00:05:55] Speaker 01:
And the judge then asked the parties, could he address eligibility now?

[00:06:01] Speaker 01:
Was that right to be ruled on?

[00:06:03] Speaker 01:
And Andro Dynamics said, yes, it was.

[00:06:05] Speaker 01:
And we said, no, it's not.

[00:06:07] Speaker 01:
It's premature.

[00:06:08] Speaker 01:
there are at least facts in dispute on that issue, and it's angiodynamics' burden, and they haven't gone.

[00:06:14] Speaker 01:
I do think that, you know, it does seem like the judge at the end of the trial terminated it because he thought these patents didn't survive 101, and I think that's clearly wrong.

[00:06:25] Speaker 01:
I think these patents are eligible at step one of 101, and if the court reaches that issue, it should still hold.

[00:06:33] Speaker 01:
These are claims to improved medical devices.

[00:06:38] Speaker 01:
They recite specific means, the combination of a power injectable port and a radiographic marker that must be perceived.

[00:06:46] Speaker 04:
But what's the legal basis that we would make that type of a determination?

[00:06:52] Speaker 04:
The procedural problem I have with the case is I don't know what the judge did.

[00:06:58] Speaker 04:
And because I don't know what the judge did, I have difficulty saying this is what I'm going to do, and this is the basis on which I'm going to do it.

[00:07:06] Speaker 04:
And so this was not a...

[00:07:08] Speaker 04:
a Section 101 decision on the J-Mall.

[00:07:11] Speaker 04:
That's what you're saying, correct?

[00:07:14] Speaker 01:
I think it was improperly timed if it was, Judge Rainier, because there were disputes of fact about eligibility.

[00:07:24] Speaker 01:
So we had moved before trial for summary judgment of eligibility at step one, and they had countermoved on 101.

[00:07:32] Speaker 01:
But the judge had sent it to trial on the grounds that there were disputes of fact under 101.

[00:07:37] Speaker 01:
And as this court has held,

[00:07:39] Speaker 01:
in Berkheimer, there can be distances back, especially at step two of the inquiry, and angiodynamics under Berkheimer for the burden to prove that by clear and convincing evidence.

[00:07:51] Speaker 01:
And at this point in the trial, the angiodynamics hadn't even put on its case.

[00:07:57] Speaker 01:
And so, you know, the judge faulted us in the colloquy that I think you're referring to, Judge Rainier, for failing to prove our patents valid.

[00:08:06] Speaker 01:
And that's error in itself.

[00:08:08] Speaker 01:
And that alone would be a basis to reverse without having to decide any of the ineligibility or invalid decision.

[00:08:16] Speaker 02:
Ms.

[00:08:16] Speaker 02:
Maynard, this is Judge Stoll.

[00:08:20] Speaker 02:
Do you think that the best place in the court's written decision, at least for thinking that it addressed eligibility, would be at page A15 at the top, where

[00:08:33] Speaker 02:
And that, to me, seems to be the most clear section of the court's opinion that addresses eligibility.

[00:08:41] Speaker 02:
Of course, it does... The judge's opinion does go on to make other assertions as well, but at least here it says the court agrees this is an eligible patent subject matter.

[00:08:55] Speaker 01:
You're looking at... Let's see.

[00:08:57] Speaker 01:
I'm sorry.

[00:08:57] Speaker 01:
I don't know what... You're looking at... Appendix page 15.

[00:09:01] Speaker 01:
Uh-huh.

[00:09:01] Speaker 02:
At the top.

[00:09:04] Speaker 01:
Right.

[00:09:06] Speaker 01:
Yes, Your Honor.

[00:09:07] Speaker 01:
Yes, Your Honor.

[00:09:09] Speaker 01:
But I think that that's clearly... He's wrong about that for two reasons.

[00:09:15] Speaker 01:
One... Can I ask you something else?

[00:09:17] Speaker 02:
I'm not saying I agree with him.

[00:09:18] Speaker 02:
I just wanted to say that that's where I think maybe it's the clearest.

[00:09:22] Speaker 02:
But I just want to make sure I ask you this question.

[00:09:25] Speaker 02:
I want to know what your view is on printed matter.

[00:09:27] Speaker 02:
If we don't think this is printed matter,

[00:09:31] Speaker 02:
How does that relate to the 101 decision?

[00:09:35] Speaker 02:
It's kind of a complicated situation where first we have to see whether something's printed matter, and then we have to look at whether the claims are directed to an abstract idea with or without the printed matter, I guess.

[00:09:50] Speaker 01:
Well, so first, Judge Dole, I think at the first step of ALIS, it doesn't play any role, the printed matter.

[00:09:55] Speaker 01:
Indiodynamics has never argued that these claims are directed solely to printed matter.

[00:10:00] Speaker 01:
And under this court's cases, then, you just look and this report, you look at the claim as a whole.

[00:10:07] Speaker 01:
And as I started to say earlier, the claim as a whole is directed to a very concrete specific invention, an improved port that has self-identifying radiographic features and methods for using it.

[00:10:23] Speaker 01:
And then the method claims have an additional reason for being valid, which is that they require a step

[00:10:31] Speaker 01:
of power injecting the patient.

[00:10:33] Speaker 01:
And under Vanda Natural Alternatives, that's an additional reason to hold them valid at step one.

[00:10:38] Speaker 01:
So at step one of Alice, I think you could hold these patents eligible to be patented without considering printed matter.

[00:10:44] Speaker 01:
I think the printed matter potentially comes in at step two of Alice, Your Honor, but I think you could also find that they have failed to show that there's a lack of an event in concept here.

[00:10:56] Speaker 01:
That would be their burden.

[00:10:58] Speaker 01:
And here, as an initial matter,

[00:11:00] Speaker 01:
The idea of power injectable ports itself was an inventive concept.

[00:11:06] Speaker 01:
This was something that the FDA warned against.

[00:11:09] Speaker 01:
Angio Dynamics recognized that our ports were an innovation.

[00:11:19] Speaker 01:
And the fact that, you know, ports were later found to be able to withstand power injectability shows that it wasn't routine and conventional and well understood at the time of these patents to have power injectable ports at all, much less power injectable ports.

[00:11:33] Speaker 01:
Yes, Your Honor.

[00:11:34] Speaker 03:
And Paige, what do you think, if you could please, maybe turn to page 18 of the Joint Appendix.

[00:11:43] Speaker 03:
large paragraph that starts off, the court finds this case is nothing but a labeling issue, and then it goes on.

[00:11:50] Speaker 03:
What do you read the district court as getting at in that paragraph?

[00:11:55] Speaker 03:
In other words, what is the judge district court saying or ruling in that paragraph?

[00:12:02] Speaker 01:
I think the judge... Sorry, Your Honor.

[00:12:04] Speaker 03:
No, no.

[00:12:06] Speaker 03:
I was just saying, I'm trying to figure that out.

[00:12:09] Speaker 01:
Again, I think to the extent this is a mystery, you know, it's all a reason to reverse and send it back.

[00:12:14] Speaker 01:
But I think that my interpretation of that paragraph is that it's further explanation of to the extent the judge ruled on patent eligibility as Judge Stoll points out.

[00:12:24] Speaker 01:
But the flaw in this rationale is that the judge, at step one, you don't focus in just on, you know, one element.

[00:12:32] Speaker 01:
And that is a legal error.

[00:12:35] Speaker 01:
You're supposed to look at the claim as a whole to decide whether it's directed

[00:12:38] Speaker 01:
to an abstract concept and these claims clearly aren't.

[00:12:43] Speaker 03:
Let me ask you if I could indulge my panel colleagues and ask one question here.

[00:12:49] Speaker 03:
We have a decision of the magistrate in which she ruled that there was a printed matter problem here.

[00:12:59] Speaker 03:
She said the printed matter didn't have patentable weight, as I understand it.

[00:13:05] Speaker 03:
And then after that, the district court judge, without going into any details, said he adopted the magistrate's decision on that issue.

[00:13:18] Speaker 03:
Where are we on that?

[00:13:22] Speaker 01:
Well, I think the court doesn't need to reach print and matter to reverse for the procedural errors and the 101 step one issue I just discussed with Judge Dole.

[00:13:29] Speaker 01:
But if the court does want to clarify that, I think the district court is wrong in finding that the radiographic letters in these claims do not receive patentable weight.

[00:13:43] Speaker 01:
The material here, the radiographic marker,

[00:13:49] Speaker 01:
interrelated in the substrate.

[00:13:51] Speaker 01:
It's both structurally and functionally related to the other elements of the claim and receives patented weight because of that.

[00:13:58] Speaker 01:
In some cases, it is the very structure.

[00:14:03] Speaker 01:
It's the shape.

[00:14:04] Speaker 04:
But the printed matter does not include the radiographic markers.

[00:14:10] Speaker 04:
And the way I understand it, the printed matter is directed to the content and the information.

[00:14:15] Speaker 04:
and not even to the means of delivering that information, which is a radiographic marker.

[00:14:20] Speaker 04:
I agree with that completely.

[00:14:22] Speaker 04:
Okay, my next question is, if we were to send this back, wouldn't we have to make some sort of comment as print and matter to give guidance to the court?

[00:14:33] Speaker 01:
I think it would be helpful to do that, Judge Raina.

[00:14:35] Speaker 01:
And first, I want to say I agree with you that even if the information conveyed by the radiographic marker

[00:14:42] Speaker 01:
is not given patent away.

[00:14:43] Speaker 01:
I agree with you that the radiographic marker itself must be, and that there must be a marker on the port that identifies the port as something, even if not as power injectable.

[00:14:55] Speaker 01:
But here, I think the power... Sorry.

[00:14:58] Speaker 04:
One last very quick question is, do you agree that this court has never addressed the printed matter doctrine under the ALICE 101?

[00:15:10] Speaker 04:
analysis at step one.

[00:15:15] Speaker 01:
I do agree with that, Your Honor.

[00:15:16] Speaker 01:
And I think, in fact, the court has suggested it doesn't come into play at step one in Miller and in King.

[00:15:33] Speaker 01:
I know I must be out of time, but if I could, I would like to say that I think

[00:15:38] Speaker 01:
Um, the, the method claims get a different printed matter analysis and that, that, that under cracks there, the method claims are clearly functionally related to the rest of the claim because they require it, uh, actually injecting the fluid.

[00:15:52] Speaker 01:
And I do think if this court would clarify that the district court made an error when it remands, that would help proceedings going forward.

[00:15:59] Speaker 01:
Um, I understand my time has expired.

[00:16:01] Speaker 04:
So yes, it has.

[00:16:04] Speaker 04:
We've got your argument.

[00:16:05] Speaker 04:
So thank you.

[00:16:06] Speaker 01:
Thank you, your honor.

[00:16:13] Speaker 04:
Okay.

[00:16:18] Speaker 04:
Councillor Cooley?

[00:16:19] Speaker 00:
Yes, Your Honor, I'm here.

[00:16:21] Speaker 04:
You may proceed.

[00:16:23] Speaker 00:
Thank you, Your Honor.

[00:16:24] Speaker 00:
May it please the court?

[00:16:25] Speaker 00:
This is Danielle Tully arguing on behalf of Angio Dynamics.

[00:16:29] Speaker 00:
Judgment was proper here because there were no disputed facts and all the evidence showed that the claims amounted to nothing more than patents on the abstract idea of identification itself.

[00:16:39] Speaker 00:
All of the asserted claims are directed to the abstract idea of identifying information about prior art ports using industry standard labels.

[00:16:47] Speaker 00:
The claims recite no improved port structure that makes the port... Is it... This is... This is Judge Raina.

[00:16:53] Speaker 04:
Is it your position that the court addressed the Section 101 issue in its entirety and resolved it?

[00:17:01] Speaker 00:
Yes, it is, Your Honor.

[00:17:02] Speaker 00:
As the court noted,

[00:17:04] Speaker 00:
The court first raised it at Appendix 25851 during the Jamal argument.

[00:17:11] Speaker 00:
At that point, Your Honor, the court reiterated that all of the trial evidence made it clear that the patents were directed to an abstract idea.

[00:17:20] Speaker 00:
At that point, Bard's counsel was invited to argue and rather than addressing step one at that point,

[00:17:26] Speaker 00:
Bard's counsel moved on to step two.

[00:17:28] Speaker 00:
The fact that the court addressed step one is further confirmed at JA 15 of the court's opinion, which Judge Stahl pointed to.

[00:17:37] Speaker 00:
The court expressly addresses the abstract idea of identification of a label.

[00:17:43] Speaker 00:
And then the court moves through doing a step two analysis.

[00:17:47] Speaker 00:
For instance, if we look at JA 12 to 13,

[00:17:51] Speaker 00:
The court correctly held that each of the claim elements are directed to generic recitations of prior art ports, industry standard labels, and standards of care that were routine, well understood, and conventional.

[00:18:04] Speaker 00:
At JA 14 to 15, the court says that the evidence of trial supported identifying ports capable of power injection by means of the medical record, the patient history,

[00:18:17] Speaker 00:
The product materials or radiograph was routine, conventional, and required by the standard of medical care existing at the time of the alleged invention.

[00:18:26] Speaker 00:
The court agrees that... Ms.

[00:18:28] Speaker ?:
Tully?

[00:18:28] Speaker 03:
Yes.

[00:18:28] Speaker 03:
Excuse me.

[00:18:28] Speaker 03:
This is Judge Shaw here.

[00:18:30] Speaker 03:
Yeah, I'm... This is, to me, is an interesting question, picking up on what Judge Rayna asked you.

[00:18:37] Speaker 03:
At page 13, the judge said the court concludes that the method claims

[00:18:45] Speaker 03:
the recites claims that are routine, well understood and conventional and then sort of ties that in to a printed matter question by saying not entitled to patentable weight because such information is not patent eligible subject matter.

[00:19:05] Speaker 03:
So I was trying to, you're absolutely right in terms of what the judge said there, but I was trying to think when I was preparing the case and looking at this, I'm saying,

[00:19:14] Speaker 03:
You know, is the judge saying here these claims fail because they don't meet 101, or is the judge saying these claims involve printed matter and it doesn't rise to patentable weight because it's not functional?

[00:19:34] Speaker 00:
I think here, Your Honor, the court is citing in Raymarco Gouldinar.

[00:19:39] Speaker 00:
And the court is recognizing that the only inventive concept that Bard pointed to throughout this case is actually the printed matter.

[00:19:47] Speaker 00:
So, throughout trials, Bard has pointed to two inventive concepts.

[00:19:51] Speaker 00:
And one is the identification of the ports, and that's the abstract idea itself.

[00:19:56] Speaker 00:
The second is the information that's conveyed by the identifiable features.

[00:20:00] Speaker 00:
But as this court recognized in Inray-Markel-Guldanar, the printed matter itself can't be what provides the inventive concept.

[00:20:08] Speaker 00:
And that's in line with the court's cases such as NYE where the court reason that to hold otherwise would be allow to allow patentees to simply provide new instructions for an old product and continue to patent them.

[00:20:22] Speaker 00:
And that just can't be the inventive concept.

[00:20:25] Speaker 00:
And here I think the court is recognizing that fact, that the printed matter can't be what the inventive concept is and the abstract idea of identification can't be what the abstract, what the inventive concept is.

[00:20:38] Speaker 00:
So where the claims themselves recite no inventive technology for improving prior art ports structure or functionality, or improving the radiographic marker functionality, that printed matter can't be what is the inventive concept.

[00:20:56] Speaker 00:
And in fact, what we look at the... Oh, I'm sorry.

[00:21:00] Speaker 04:
What is the printed matter concept?

[00:21:03] Speaker 04:
Just so, do you want to ask a question?

[00:21:06] Speaker 02:
That's okay.

[00:21:06] Speaker 02:
You go ahead.

[00:21:07] Speaker 02:
I'll ask next, please.

[00:21:09] Speaker 04:
Okay.

[00:21:09] Speaker 04:
I'll be done here real quick.

[00:21:12] Speaker 04:
What if the printed matter is connected to a functional relationship between the printed matter and a function?

[00:21:22] Speaker 00:
Well, it's actually the information that has to have the functional relationship.

[00:21:26] Speaker 00:
So it's not enough that the radiographic marker is itself located on the port.

[00:21:31] Speaker 00:
For instance, in AstraZeneca, the court held that it doesn't matter where the instructions are located if they're on a label.

[00:21:39] Speaker 00:
The instructions must actually be related to the underlying substrate to cause it to become a manufacturer with new functionality.

[00:21:46] Speaker 04:
In this situation, doesn't the functioning of one depend on the other?

[00:21:54] Speaker 00:
No, Your Honor, it doesn't.

[00:21:56] Speaker 00:
Just because the radiograph, and that's actually highlighted by the fact that the claims also include separated features.

[00:22:03] Speaker 00:
The separated features are claimed the exact same way as the radiographic markers.

[00:22:07] Speaker 00:
They provide no structural details for either.

[00:22:10] Speaker 00:
And the separated features are things like stickers and key chains and labels.

[00:22:15] Speaker 00:
So the fact that those are separated from the port but serve the exact same function as the radiographic marker,

[00:22:22] Speaker 00:
undercut any argument that the radiographic marker itself creates some kind of functional relationship.

[00:22:30] Speaker 00:
Also, the radiographic marker, the way it's claimed, the claims recite no structural details at all about how this radiographic marker has to be applied, how it has to be viewed.

[00:22:43] Speaker 00:
There's no structural elements to that claim element.

[00:22:47] Speaker 02:
Instead, the claim... Excuse me, counsel.

[00:22:50] Speaker 02:
Why isn't the phrase radiographic marker itself structural?

[00:22:57] Speaker 00:
Because there's no dispute, Your Honor, that radiographic markers have long been known in the art.

[00:23:03] Speaker 02:
Just a minute.

[00:23:04] Speaker 02:
You said it's not structural at all.

[00:23:06] Speaker 02:
I don't know.

[00:23:07] Speaker 02:
The fact that it's known doesn't indicate whether it's structural or not.

[00:23:11] Speaker 02:
It's certainly a structure, and you've got to read claims from the point of view of one of our engineering skills in the art, right?

[00:23:17] Speaker 00:
I agree, Your Honor, that the radiographic marker itself is structural, but it's the information that has to have some kind of connection to functional relationship with the port.

[00:23:26] Speaker 00:
So again, the fact that the radiographic marker itself is, it might be a structural element, it doesn't mean that it then has a structural relationship.

[00:23:36] Speaker 00:
For instance, the magistrate reasoned that these claims here are unlike the claims in ROICA because the X-ray doesn't actually transform the information that's conveyed by the radiographic marker.

[00:23:48] Speaker 00:
Instead, it merely conveys that information.

[00:23:51] Speaker 02:
So... I'd like to ask you another question, if I could, about the Mishurial Appendix A-18.

[00:23:58] Speaker 02:
Here, at the very end of the opinion, the court has this paragraph that Judge Schall referred to earlier during argument.

[00:24:05] Speaker 02:
about, you know, the court finds this case nothing but a labeling issue.

[00:24:10] Speaker 02:
And this whole paragraph really seems to be talking about the printed matter issue.

[00:24:14] Speaker 02:
How do you read this paragraph?

[00:24:17] Speaker 00:
So I read that paragraph again as saying that the only inventive concept that Barr has pointed to throughout this litigation is the content of this information.

[00:24:28] Speaker 00:
But again, because the content of the information isn't what makes the port power injectable,

[00:24:33] Speaker 00:
It's not, it can't be enough here.

[00:24:39] Speaker 00:
So we're just like in Raymarco Gould and R where the fact that the etchings were on the dice didn't transform the dice into something new.

[00:24:49] Speaker 00:
The dice was exactly the same as it existed in the prior art.

[00:24:53] Speaker 00:
And here we have admissions that the ports themselves are admitted prior art here.

[00:24:59] Speaker 00:
We can go through the patents say that the port structure was long known in the art

[00:25:03] Speaker 00:
And admissions came in at trial that BARD actually did its own power injection testing in off-the-shelf prior art ports.

[00:25:12] Speaker 00:
So it made no structural improvements to the ports themselves.

[00:25:18] Speaker 00:
In its pretrial admissions and at trial, BARD also admitted that it made no structural improvements to the radiographic markers themselves.

[00:25:26] Speaker 00:
Again, it just used industry standard labeling techniques.

[00:25:28] Speaker 00:
The same thing applied.

[00:25:31] Speaker 03:
Judge Shaw here.

[00:25:32] Speaker 03:
First of all, don't be bashful about telling me if you think what I'm going to say is totally wrong.

[00:25:39] Speaker 03:
That's your job at this point.

[00:25:41] Speaker 03:
But the way I was looking at this case, I was thinking to myself, OK, first question I have to decide is, do we have patent eligible subject matter?

[00:25:52] Speaker 03:
That's question one.

[00:25:53] Speaker 03:
Then question two is, all right,

[00:25:57] Speaker 03:
you would dispute this, but assume for the moment there is patent-eligible subject matter under 101.

[00:26:03] Speaker 03:
The next thing I have to decide is whether the printed matter here bears a functional relationship to the underlying substrate in line with, say, Praxer and DiStefano so that it can be used to withstand a validity challenge in the face of prior art.

[00:26:27] Speaker 03:
Okay?

[00:26:28] Speaker 03:
That's the way I was looking at the analytical construct.

[00:26:33] Speaker 03:
Am I right or wrong?

[00:26:35] Speaker 03:
Or half right or half wrong?

[00:26:38] Speaker 03:
You understand what I said?

[00:26:40] Speaker 00:
I understand what you're saying.

[00:26:41] Speaker 00:
So printed matter is actually relevant to both the invalidity and the eligibility context.

[00:26:48] Speaker 00:
It does come up in invalidity cases where it can't be used to distinguish the art.

[00:26:53] Speaker 00:
And those are the cases like the Praxair cases that you just referenced.

[00:26:58] Speaker 00:
But it also comes up in 101 cases, such as Gouldinar, where it can't be relied on to supply the invention concept.

[00:27:06] Speaker 00:
And I think that that's really what the court's opinion was getting at in citing Gouldinar.

[00:27:12] Speaker 03:
Well, what about saying, in this case, you don't have a 101 issue because you've got a physical object.

[00:27:18] Speaker 03:
You've got these vascular ports.

[00:27:23] Speaker 03:
You know, there's nothing abstract about them.

[00:27:27] Speaker 03:
They serve a very physical purpose.

[00:27:29] Speaker 03:
Now, there may well be a validity issue in terms of prior art, but why are these vascular ports ineligible under 101?

[00:27:43] Speaker 03:
Why are they abstract?

[00:27:44] Speaker 03:
They're physical.

[00:27:45] Speaker 03:
They're tangible.

[00:27:47] Speaker 00:
Your Honor, and I would say that in this case, we are like ChargePoint.

[00:27:51] Speaker 00:
where the patentee argued improvements to tangible items, but the claims didn't recite any improvements to tangible items.

[00:28:03] Speaker 00:
So in ChargePoint, where the claims didn't recite any improvements to the tangible items themselves, and here the claims don't recite any improvement to the structure or function of the ports themselves,

[00:28:14] Speaker 00:
then again, this is still ineligible subject matter where the only inventive concept again comes back to the abstract idea of identification.

[00:28:22] Speaker 03:
Thank you for indulging my question.

[00:28:27] Speaker 00:
No, thank you, Your Honor.

[00:28:28] Speaker 00:
And I just want to get back to the issue of whether Bard had a chance to address

[00:28:37] Speaker 00:
In eligibility at trial, BARD was not prevented from introducing evidence at trial, especially not evidence of its inventive concept in its case in chief.

[00:28:49] Speaker 00:
BARD, in its case in chief, affirmatively told its invention story.

[00:28:53] Speaker 00:
And in telling its story, BARD introduced evidence that it used off-the-shelf ports for its power injection testing and that it had to make no structural changes to its off-the-shelf ports.

[00:29:03] Speaker 00:
to have them structured for power injection as the claims were construed.

[00:29:09] Speaker 00:
It also introduced evidence that it used industry standard labels and industry standard radiographic markers to identify its ports.

[00:29:18] Speaker 00:
It introduced evidence that its ports were already being identified in conjunction with CT procedures.

[00:29:25] Speaker 00:
And just as a noble pharma, having introduced this evidence, if there was any evidence

[00:29:30] Speaker 00:
related to an improvement, it was incumbent on BARD to raise it at that point.

[00:29:34] Speaker 00:
Angio Dynamics was able to get further admissions on CROSS, but in all instances, BARD had a chance to redirect to bring in any evidence that it thought was in dispute to show what improvements it actually added to either the structure or function of prior art ports or radiographic markers.

[00:29:53] Speaker 00:
In BARD's brief, it points to examples of where it says that it was precluded from

[00:29:59] Speaker 00:
raising evidence related to invalidity or ineligibility.

[00:30:03] Speaker 04:
Counselor, let's focus a little bit on the red graphic marker.

[00:30:07] Speaker 04:
Now you said, or you inferred about it, that it was routine and conventional.

[00:30:13] Speaker 04:
Isn't that question whether something is routine and conventional a fact question?

[00:30:19] Speaker 00:
Your Honor, the question of whether something is routine or convention, well understood and conventional does have underlying factual issues as this Court recognized in

[00:30:29] Speaker 00:
Berkheimer, but here we're actually like the situation in Berkheimer where the court found that certain of the claims did not survive step two.

[00:30:39] Speaker 00:
So at step two in Berkheimer, the patentee admitted that the claim components existed for years before his patents and those limitations combined with limitations of analyzing and comparing did not transform the abstract idea into something patent eligible.

[00:30:55] Speaker 00:
So here we are just like that.

[00:30:57] Speaker 00:
The patent itself admits that all of the port structure was known in the ARC and that the radiographic labels and the separated features were all known in the ARC.

[00:31:08] Speaker 00:
And then at trial the same admissions came in that no changes had to be made for ports to be structured for power injection and that BART actually knew that doctors were already using prior ARC ports for power injection procedures.

[00:31:22] Speaker 00:
Here, while step two may have a factual component, there are no facts in dispute.

[00:31:28] Speaker 00:
And I understand that I'm out of time, Your Honor.

[00:31:32] Speaker 04:
Okay, we have your case.

[00:31:34] Speaker 04:
We thank you very much for your argument.

[00:31:37] Speaker 04:
Ms.

[00:31:39] Speaker 04:
Maynard, you have three minutes.

[00:31:42] Speaker 01:
Thank you, Judge Rainier.

[00:31:43] Speaker 01:
I appreciate it.

[00:31:44] Speaker 01:
So I just want to say, first, the printed matter inquiry is irrelevant to step one of ALIS, and I think these patents are eligible under step one.

[00:31:52] Speaker 01:
If the court goes on and decides the printed matter issue to clarify matters for remand, I think the printed matter should be given patentable weight.

[00:32:00] Speaker 01:
The structure here, so first, the combination was invented.

[00:32:05] Speaker 01:
It was by combining power injectable ports with radiographic markers that we introduced new functionality.

[00:32:11] Speaker 01:
And it became so before this invention, the FDA warned against power injecting.

[00:32:16] Speaker 01:
And after this invention, BARD's inventions became the accepted industry standard.

[00:32:21] Speaker 01:
This is like the functionality in Miller.

[00:32:24] Speaker 01:
So, Council, my friend wants to say, well, didn't we increase the power injectability of the court?

[00:32:30] Speaker 01:
Well, the functionality here, though, is like the combination in Miller, the measuring cup case.

[00:32:34] Speaker 01:
There, the measuring receptacle.

[00:32:36] Speaker 03:
Yes, Your Honor.

[00:32:38] Speaker 03:
One question.

[00:32:39] Speaker 03:
Am I correct in thinking, and please tell me if I'm wrong,

[00:32:45] Speaker 03:
The significance of printed matter is, if printed matter is found to have patentable weight, the significance of that finding is that it can be used possibly as a factor in distinguishing over prior art.

[00:33:05] Speaker 03:
Am I right or wrong on that?

[00:33:07] Speaker 01:
That's correct, Your Honor.

[00:33:09] Speaker 03:
OK.

[00:33:10] Speaker 01:
That's correct.

[00:33:11] Speaker 01:
And that's why it would be helpful to clarify it on remand.

[00:33:13] Speaker 01:
here that we... Go ahead.

[00:33:17] Speaker 03:
Sorry to jump in on you, but time is... So we could, in your view, say that this is printed matter, number one, but looking at the... In the Praxair de Stefano approach, it has patentable weight, but we can't say anything about whether

[00:33:41] Speaker 03:
how that now stacks up against prior art that may be asserted.

[00:33:44] Speaker 03:
So we would have to go back on that.

[00:33:48] Speaker 01:
I think if you would hold it eligible at step one under ALICE and then you would say what the printed matter had a patentable weight and remand for further proceedings on that understanding.

[00:34:00] Speaker 03:
Like Judge Raina was suggesting guidance possibly.

[00:34:03] Speaker 01:
Yes, Your Honor.

[00:34:05] Speaker 01:
Like the court does in an analogous situation like with claim construction, sometimes you correct things for remand.

[00:34:10] Speaker 01:
It would be helpful to clarify it here.

[00:34:12] Speaker 01:
And here are just, I mean, two quick points.

[00:34:14] Speaker 01:
One, this is structurally related like in ROYCA, the happy, smiley face on frowny face.

[00:34:23] Speaker 01:
The ports, when seen on a radiographic, an x-ray, are seen when planted inside a body.

[00:34:30] Speaker 01:
That's the beauty of it here.

[00:34:32] Speaker 01:
And then it's structurally related, creates a foolproof way that a practitioner can see once the port's inside a body.

[00:34:41] Speaker 01:
even if the person has lost the record, even if the person doesn't know that the port is safe to be power injectable.

[00:34:46] Speaker 01:
And that is part of the invention that furthers the invention.

[00:34:53] Speaker 01:
in the same way that the indicia on the measuring cup, even though the receptacle was a half cup, a half cup, a half cup, no matter what, when you put the indicia on it of a cup, it made it easier to make fractional recipes.

[00:35:06] Speaker 01:
You could still make fractional recipes without the indicia, just like, you know, potentially you could power inject a port that didn't have a radiographic marker identifying it as power injectability, but this creates new functionality in the same way that the indicia on the Miller cup created new functionality.

[00:35:23] Speaker 01:
And the court should hold that the content here gets patented away.

[00:35:26] Speaker 01:
And at a minimum, it does for the method claims under pracsayer.

[00:35:30] Speaker 01:
And we would ask this court to clarify that and reverse the judgment for further proceedings.

[00:35:35] Speaker 04:
Counsel, before you sit down, let me ask you something.

[00:35:39] Speaker 04:
Now, you said that printed matter is irrelevant at step one.

[00:35:45] Speaker 04:
I'm not too sure of that.

[00:35:46] Speaker 04:
This court has never taken up that issue.

[00:35:48] Speaker 04:
And I think that if it was to at this time, it would be one of first impression.

[00:35:53] Speaker 04:
But why would you say that it's irrelevant?

[00:35:56] Speaker 01:
Is that definitive to you?

[00:36:00] Speaker 01:
Well, I think, no, it isn't, Your Honor.

[00:36:03] Speaker 01:
It's not definitive.

[00:36:06] Speaker 01:
Because, of course, when you're at step one, you're looking at the claim as a whole in its entirety.

[00:36:13] Speaker 01:
And if you view printed matter, like the fact that there might be some printed matter in something like the fact that there might be a mental step or an abstract concept buried within a claim,

[00:36:22] Speaker 01:
You still step out and look at the whole claim in its entirety.

[00:36:26] Speaker 01:
And when you do that here, this is clearly eligible subject matter.

[00:36:30] Speaker 01:
It's an improved machine, an improved power injectable port with specific structural markings, radiographic markings.

[00:36:39] Speaker 01:
And I disagree with my friend.

[00:36:41] Speaker 01:
The specification does describe details about it.

[00:36:44] Speaker 01:
Persons with a skill in the art would know how to do it.

[00:36:47] Speaker 01:
And so that's why I think that.

[00:36:51] Speaker 01:
And so I think, Judge Rainier, if the claim were to printed matter in entirety and Andrew Genang hasn't claimed that, then, you know, then the claim would be to, you know, that would be a different question.

[00:37:05] Speaker 01:
But where it's just a piece of the claim, that's not the inquiry.

[00:37:08] Speaker 01:
We don't focus on whether or not the printed matter limitation itself has patentable weight.

[00:37:12] Speaker 01:
The question is whether the claim is full.

[00:37:15] Speaker 04:
Do any of my colleagues have any questions?

[00:37:19] Speaker 04:
No.

[00:37:21] Speaker 02:
Not for me.

[00:37:23] Speaker 04:
Okay, good.

[00:37:24] Speaker 04:
We thank you for the arguments.

[00:37:29] Speaker 04:
This case is now submitted.