[00:00:00] Speaker 03:
The United States Court of Appeals for the Federal Circuit is now open and in session.

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God save the United States and this honorable court.

[00:00:11] Speaker 04:
Good morning, ladies and gentlemen.

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We have five cases on the calendar this morning, three consolidated cases from the PTAB, patent case from the ITC, and a case from the Court of Federal Claims that has been submitted in the briefs and not argued.

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Consolidated cases are CR barred versus Nedline Industries 2020-1900, 1908, 1910.

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Mr. Matsui, please proceed.

[00:00:45] Speaker 01:
Thank you, Your Honor, and may it please the Court.

[00:00:48] Speaker 01:
Brian Matsui for CR barred.

[00:00:50] Speaker 01:
I would like to primarily address two issues.

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First, the Board's error with respect to the requirement that two syringes be stored in one compartment

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and a medical assembly in another compartment.

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While that error runs through all three patents, it is enough to reverse or vacate the board's decision for all the claims from Claim 45 and higher that are addressed in the 088 patent appeal.

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Second, I would like to address the requirement in Claim 7 of the 596 patent that the drainage bag be positioned between the tray bottom and the catheter.

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This error adds Claim 7, 8, and 13

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that should be reversed or at least vacated in the 596 patent appeal.

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With any time remaining, I will address the other issues.

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The board's errors there largely flow from or are related to the kinds of errors the board made and the two issues that I want to focus on.

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So starting with the two syringes in one compartment requirement, the board committed a simple legal error in how it applied obviousness.

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This is a simple requirement.

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It just requires two syringes in one compartment

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and a medical assembly in another compartment.

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The board found that the prior art disclosed all the elements in the claim tray, syringes, a foley catheter, sterile materials, multi-compartment single-layer trays.

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But the board imposed anticipation-like requirements in the obviousness analysis.

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It required that a single reference expressly disclose two syringes in one compartment, and it dismissed each reference one by one

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while ignoring combinations and the creativity of a person of ordinary skill in the art.

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If we look at the 088 appendix, pages 44 to 47, in four pages there, the board individually dismisses salazo, serrani, and distin for not expressly describing or describing two syringes in the requirement, and it does so about 10 times in those four pages.

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Now, setting aside that another reference

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You're saying that it's fairly obvious within the person of ordinary skill to add a second item of the same nature as the first item in a kit of this sort?

[00:03:10] Speaker 01:
Certainly, Your Honor.

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I mean, for over 60 years, there have been single-layer trays with these types of items.

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And we have the MI reference that shows multiple syringes in a single compartment.

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We have serrani, which shows

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in single layer trays, cleaning balls stored together.

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And it was well within the capabilities of a person of ordinary skill in the art to move syringes from one tray to another.

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I think an important fact here is that Solazo itself discloses two syringes.

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It specifies that one of those syringes, an inflation syringe, is in compartment 27, and the medical assembly is in compartment three.

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But for that second syringe, which is an irrigation syringe,

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It doesn't specify what compartment that that syringe is in.

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And there just aren't very many places that you could put that second syringe.

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As our expert explained, it was really compartment three or compartment 27.

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So you're really dealing with a finite number of predictable choices of where you could put that second syringe.

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It was really only going to be in one of those two compartments.

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But as I mentioned... What kind of deference do we owe

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the PTAB.

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They didn't fairly start a job, did they?

[00:04:27] Speaker 01:
Well, this is a legal error, Your Honor.

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So this is reviewed de novo because the board, when you look at those pages from Appendix 44 to 47, it was just analyzing each reference one by one and faulting them for Sollozzo not expressly describing two syringes in one compartment or Sereni only describing

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a single syringe.

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That's a legal error, what the board did there with respect to the obviousness analysis.

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But even if the court were to sort of look at this as a factual issue, which I don't think it should because of the requirement of expressed disclosures, there certainly isn't any substantial evidence to support the board's decision that a person of ordinary skill in the art could not put two syringes in one compartment, particularly because really the question here is just where do you put Solazzo's

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second syringe, because Solazo describes that there are two syringes in it.

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You have both an irrigation syringe and an inflation syringe, and that irrigation syringe has to go somewhere in the tray.

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So really there are only a couple options where you could put it.

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Do you think the board was essentially examining for anticipation, not obviousness?

[00:05:46] Speaker 01:
It really seems that way, that it was looking for, at least with respect to, you know,

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these core claim requirement it was looking for anticipation like references because it just examined each reference one-by-one and then the only fault that really gave at all was that the reference itself did not describe or expressly describe two syringes in one compartment and that's why this that really makes this case you know like almost like a ksr where you you didn't have prior out that you know it separately

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disclosed electronic sensors, pedals with six pivot points, no single prior reference disclosed that.

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But the claimed arrangement was obvious.

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And that's what the Supreme Court has said.

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That's what this Court has said on numerous occasions.

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Mr. Massoui, this is a question.

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For this category of claims dealing with two syringes in one compartment, medical assembly in the second compartment, I believe there is at least one of the claims in this category

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that talks about specifically an inflation syringe and a lubrication syringe.

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Is that right?

[00:06:58] Speaker 01:
Well, there's, with respect to like claim 45 and higher, it's really talking about just two syringes in one compartment.

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Right.

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That's true for the 08-8 patent.

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I'm talking about one of the other two patents in this consolidated set of appeals or this combined set of appeals.

[00:07:15] Speaker 02:
Yes, Your Honor.

[00:07:16] Speaker 00:
Claim seven of the 596 patent, I think, is the inflation and lubrication syringe, correct?

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That's correct.

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And there's no dispute, though, that it was.

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So, Mr. Matsui, so I understand your theory of obviousness for claim seven of the 596 patent would be that it would be obvious or a skilled artisan would be motivated to have three syringes in compartment 27 of SELASO?

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I mean, certainly that is.

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I mean, just to take this

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your question in steps.

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I mean, it would have been obvious to replace a lubrication syringe for the lubrication tube.

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That's basically undisputed.

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And the board and the 400 IPR agreed that it would have been obvious to place lubricant in a syringe and to substitute the lubricant syringe for a lubricant tube.

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But yes, I mean, MI teaches that you can put three syringes in a single compartment.

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So it would have been obvious, and certainly within the skill of a person of ordinary skill in the art,

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to put all three syringes in compartment 27.

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There's nothing that would dissuade a person from ordinary skill in the art from doing that.

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And it certainly was within their level of skill.

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And you had references like MI, which had the multiple syringes, three syringes, in fact, in one compartment.

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You have Serenity, which shows storing like materials together.

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Persons with ordinary skill in the art, as both Distant and Serenity show, would want to put things

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You know, in an order that would be useful so they could easily move the syringes around to find a good way for them to be used.

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But then, looking at Claim 7, the other requirement in Claim 7 in the 596 patent that I'd like to talk about, which is the drainage bag positioned between the Foley catheter and the tray bottom, which affects Claim 7, 8, and 13 in the 596 patent.

[00:09:11] Speaker 01:
The board made two errors there.

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And the first is that it repeated its express disclosure requirement.

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It effectively required a picture specifically showing the drainage bag between the tray bottom and the catheter.

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And we're in the 596 patent, which is the 1910 appeal.

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And if we look at Appendix 20,

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of the board's decision, they say Serene simply fails to expressly describe or illustrate a fluid receptacle that is wholly located between the bottom of the container and the catheter.

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In Appendix 19, it says, without such an expressed description, we agree with Dr. Singh that Serene illustrates at least a portion of the fluid receptacle being located above the catheter, not between the catheter and the bottom of the container.

[00:10:06] Speaker 01:
And then that matter next week.

[00:10:08] Speaker 04:
Let me ask you, is it your view that arranging known items used for the known usual purpose differently is within the skill of the art?

[00:10:25] Speaker 01:
Yes, your honor.

[00:10:26] Speaker 01:
And I don't think there's any dispute that you could move these items in different containers

[00:10:35] Speaker 01:
within the single-layer layer tray.

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I mean, the board found that in the 400 IPR appeal, the 400 IPR, which Medline did an appeal, that you could move various items and there would be motivation to combine references like Serrani and Solazo together.

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So I don't think that there can be any dispute here that it was within the level of ordinary skill in the art.

[00:11:03] Speaker 01:
In this very simple field,

[00:11:05] Speaker 01:
to be able to arrange items in different ways.

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And then you have prior references like Serenity and Distin, which basically provide motivation for persons of ordinary skill and the art to do so in ways that would be convenient for the user.

[00:11:22] Speaker 00:
This is Judge Bryson.

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I wonder if I could turn your attention, if you were done with that discussion, but either complete your thought on that or turn to claim one of the 088.

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And in particular, if you would address the limitation requiring the first compartment base member defining a mnemonic device indicating which of the devices is to be used first.

[00:11:52] Speaker 01:
Yes, Your Honor.

[00:11:55] Speaker 01:
So with respect to the syringes at different heights requirement of the mnemonic device requirement, all that's required with respect to that claim requirement is some sort of base structure that would basically indicate a different height requirement.

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So that would indicate to the user which syringe basically to use first.

[00:12:16] Speaker 00:
Let me ask you a follow-up question then with respect to that assertion.

[00:12:21] Speaker 00:
Do you think that if

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one syringe is slightly higher than the other, but they are at opposite ends of a large chamber, that that is enough by virtue of their slight difference in height to establish the mnemonic device limitation?

[00:12:41] Speaker 01:
I think so, because these are very broadly written claims.

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But I don't think that the court has to go so far where you say it's a very slight level of height.

[00:12:49] Speaker 01:
You have Salaza, which has a terrorist

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a terrace bottom, the board found that it has a terrace bottom with a high area and a low area and has the lubricant at a higher level than it has the inflation syringe.

[00:13:05] Speaker 01:
And given that terrace bottom, a person of ordinary skill would understand that you have the different height requirement here that's required by

[00:13:14] Speaker 01:
by these claims.

[00:13:15] Speaker 00:
Now, some of the claims require different height requirement is required by a number of claims, but the mnemonic device requirement is, as far as I can tell, only in two of the independent claims, including claim one of the 088.

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And so what I'm trying to see here is whether your argument is that as long as there is a difference in height

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that satisfies the mnemonic device requirement, and in particular, the requirement that the compartment base member defines such a mnemonic device.

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In your view, is height difference enough?

[00:13:57] Speaker 01:
So I think to sort of take apart that question, Your Honor, the base member in Solazo is terraced.

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And so in that sense, it is having a mnemonic device.

[00:14:08] Speaker 01:
And the height requirement comes from the fact

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that the patent itself says that having things at different heights is a mnemonic device.

[00:14:18] Speaker 01:
It has, like, for example, a stair-stepped base number.

[00:14:22] Speaker 02:
Mr. Matsui, I realize that Salasso itself describes the floor, the tray, as a terrorist arrangement.

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But in reality, I think we can all agree it's a sloped floor to the tray, right?

[00:14:37] Speaker 02:
And the board then made a fact-finding that

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any syringe that's placed on the sloped portion of the floor would roll down to the bottom, to the flat bottom section of the tray.

[00:14:52] Speaker 02:
Is that right?

[00:14:54] Speaker 01:
I mean, yes.

[00:14:55] Speaker 01:
If you took all the items out, the board was saying that the items might fall down to the bottom.

[00:15:01] Speaker 01:
But that's part of the problem because the board there imposed additional claim requirements in its analysis because it basically

[00:15:10] Speaker 01:
required that the syringes be held in place without anything else helping with the same place.

[00:15:18] Speaker 01:
It requires specific contour and shape for the syringes to be held.

[00:15:22] Speaker 01:
But nothing on the claims require that.

[00:15:24] Speaker 01:
All it requires is the base number that has the mnemonic device, which we have as the terat bottom, or in the claims that just require, because some claims don't require the mnemonic device, and the claims just require different heights.

[00:15:36] Speaker 01:
It just requires them to be supported at different heights.

[00:15:40] Speaker 01:
And nothing in that claim language would require that it's the base alone that has to support the syringes at different heights, or that the base alone has to provide that height requirement.

[00:15:55] Speaker 01:
And so it was only by the board's decision.

[00:15:59] Speaker 02:
I guess if you look at claim 25, it recites that the first compartment itself is supporting the first and second syringe

[00:16:10] Speaker 02:
at different heights.

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

[00:16:13] Speaker 02:
In the predetermined steps of the catheterization procedure.

[00:16:16] Speaker 02:
So I guess what I'm looking at there is why was it wrongheaded of the board to understand that this limitation is calling for something about the design of the compartment itself that supports these syringes at different height levels.

[00:16:36] Speaker 01:
Well, you know,

[00:16:38] Speaker 01:
the base of the tray is still supporting the syringe, even if it is resting on other items.

[00:16:43] Speaker 01:
It's just like I'm sitting on a chair right now.

[00:16:46] Speaker 01:
And, but the floor is still supporting me even though I'm sitting on the chair that the issue here is just whether or not with this broad claim language, whether the syringe is being supported by the tray.

[00:16:59] Speaker 01:
And it is, even if there are other items that are helping it maintain that different height.

[00:17:04] Speaker 01:
And we have in here, as I mentioned,

[00:17:06] Speaker 01:
a terrace bottom, so we have a tray bottom shape that would basically lead to those syringes to be stored at different heights.

[00:17:15] Speaker 01:
And there's just nothing in the claims that require that it be supported by the tray bottom alone or that have that specific shape or contour which the board required.

[00:17:25] Speaker 01:
And just, you know, an additional point I'll make, Your Honor, is that we were never given any notice that the board was going to impose these requirements upon us until the final written decision.

[00:17:36] Speaker 01:
So, at the very least, we should get a remand.

[00:17:38] Speaker 02:
In the patent owner's response at JA 542, didn't the patent owner make this very argument that Salazzo's sloping floor can't possibly support the syringe located there because it'll just roll down to the bottom?

[00:18:00] Speaker 01:
Your Honor, but they never asked for any sort of specific claim construction with respect to

[00:18:05] Speaker 01:
this requirement.

[00:18:08] Speaker 01:
It was only in the final decision that you started to get language like the contour and shape.

[00:18:13] Speaker 02:
The point is that wasn't that enough notice to you that clearly the patent owner was arguing inside of that argument against Salopso was the patent owner was contemplating a specific conception of this different height limitation and what's required of the design and the trade to

[00:18:34] Speaker 02:
to create and establish different height arrangements to support the syringes?

[00:18:43] Speaker 01:
Yeah, I think that that just was not specific enough to give us the notice that would be required when, particularly, had we known that the board was going to impose these requirements, we could have shown that you could have different height requirements, like serrani, where it shows the forceps are stored above the cleaning balls.

[00:19:04] Speaker 01:
I don't think that that's a situation that's fair to the petitioner to have, or to a party to have a claim construction effectively imposed on us in the final written decision.

[00:19:15] Speaker 01:
And it makes it like those, the other cases where this court has remanded.

[00:19:19] Speaker 00:
Mr. Ibatue, since we're beginning to run out of time, I would like for you to address, if you would, claims 10 and 15 of the 761 patent

[00:19:33] Speaker 00:
And in particular, the limitations requiring that the first compartment lubricating jelly chamber lubricate as the catheter passes from one chamber to the next.

[00:19:47] Speaker 00:
I don't see that limitation being suggested

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by anything in the prior art references other than that little notch in Salazzo's divider?

[00:20:03] Speaker 00:
Do you rely entirely on that little notch?

[00:20:07] Speaker 01:
I mean, yes.

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The notch is what shows that you can have the pass-through limitation made as you go from one compartment to the other.

[00:20:16] Speaker 01:
And Medline itself really doesn't make any arguments with respect to this limitation other than to say that

[00:20:23] Speaker 01:
you couldn't or wouldn't put lubricant into the compartment 27 of Solazo.

[00:20:33] Speaker 01:
So that's basically the idea.

[00:20:35] Speaker 00:
The idea, since the limitation requires that it be lubricated as the catheter passes from one to the other, is the idea that you would put lubrication on the edge of the notch.

[00:20:49] Speaker 00:
Is that the concept that you have in mind?

[00:20:53] Speaker 01:
No, as you would pass the catheter through, then it would basically have the lubrication that would go from one compartment to the other.

[00:21:02] Speaker 04:
Mr. Matsui, would you regard that as a use limitation?

[00:21:11] Speaker 04:
And this is an article of manufacture.

[00:21:15] Speaker 04:
It's not a method claim.

[00:21:17] Speaker 04:
Would you regard that lubrication as not

[00:21:23] Speaker 04:
lending patentable significance to this question?

[00:21:31] Speaker 01:
Yes, Your Honor.

[00:21:32] Speaker 01:
All that is required here are the structures, and we have the necessary structures disclosed in the prior art.

[00:21:41] Speaker 01:
If there are no other questions, then I'd like to reserve my time for rebuttal.

[00:21:46] Speaker 04:
We will do that.

[00:21:48] Speaker 04:
Mr. Hoover.

[00:21:54] Speaker 03:
uh... yes your honor uh... a question is by uh... am i audible enough okay well uh... your honor thank you very much good morning and may it please the court Alan Hoover for Medline the uh... challenger in this case Bard in its briefing and at the PTAB has ignored

[00:22:23] Speaker 03:
a number of fundamental issues with their patent challenge.

[00:22:28] Speaker 03:
One question that must be asked in an obviousness analysis is, was there a need in the art?

[00:22:36] Speaker 03:
And did the patent owner or the patentee solve that need or attempt to solve that need with their... Mr. Hoover, I don't know that that's the first question in an obviousness analysis.

[00:22:51] Speaker 04:
Isn't this a KSR case where we've got an article of manufacture consisting of all known materials used for their well-known purposes arranged in various ways and the only distinguishing features seem to be the shape of the container and perhaps a use aspect to some of the claims?

[00:23:21] Speaker 03:
I think the claims here are directed towards a product or method where the components are known in the arts but are arranged and provided in a new way.

[00:23:36] Speaker 00:
Did you say a product or method?

[00:23:39] Speaker 00:
I thought they were all apparatus claims.

[00:23:41] Speaker 03:
I believe they're all apparatus claims and the challenge claims for this appeal.

[00:23:46] Speaker 03:
Yes, Your Honor.

[00:23:49] Speaker 03:
All right.

[00:23:50] Speaker 03:
the stilato reference, the problem to be addressed is the county problem, catheter-associated urinary tract infection.

[00:24:00] Speaker 03:
And we asked the experts for BARD and the expert for MEDLINE both testified that the stilato problem or the stilato reference would not be useful in solving the county problem.

[00:24:16] Speaker 03:
BARD has not rebutted that in its

[00:24:19] Speaker 03:
briefing before the course, but both party experts have agreed that that was the case, that lots of reference would not be useful in solving the county problem.

[00:24:31] Speaker 03:
I'm not sure how the obvious challenge that Bob raises gets off the ground with that unrebutted... Mr. Hoover?

[00:24:40] Speaker 02:
Mr. Hoover, I understand you have this broad-based position, but it would really help me if we got down

[00:24:48] Speaker 02:
to something more nitty-gritty as to the different issues with specific claim limitations.

[00:24:55] Speaker 02:
Like for example, why wouldn't it be obvious to put two syringes into Salasso's compartment 27?

[00:25:05] Speaker 02:
We know there's a second syringe.

[00:25:08] Speaker 02:
Salasso doesn't identify where it stores that second syringe, but it would seem to be plenty obvious

[00:25:17] Speaker 02:
to a skilled artisan that you would put it where the other syringe is already illustrated as being disclosed, that is, compartment 27.

[00:25:26] Speaker 03:
Celasto has multiple compartments, Your Honor.

[00:25:30] Speaker 03:
It has two lubrication compartments.

[00:25:32] Speaker 03:
It has a lubricant packet.

[00:25:34] Speaker 03:
And for example, one skilled in the art might consider placing the lubricant packet in the lubrication channel or lubrication well of Celasto.

[00:25:44] Speaker 03:
And if there were a syringe, it could be placed in there.

[00:25:46] Speaker 02:
You're saying a syringe could be put in the lubrication well 31 or 33?

[00:25:51] Speaker 02:
Yes.

[00:25:55] Speaker 03:
The board found that it was not obvious to do that with respect to claim 45 of the 088 patent.

[00:26:08] Speaker 03:
The board considers the expert testimony

[00:26:11] Speaker 03:
and considered the references in detail and made a factual finding.

[00:26:14] Speaker 02:
Okay.

[00:26:15] Speaker 02:
The question is why wouldn't it be obvious to place Salazzo's second syringe in any existing compartment of Salazzo?

[00:26:28] Speaker 03:
I think that the claim requires more than just two syringes in a compartment.

[00:26:34] Speaker 02:
I'm just talking about that particular limitation though.

[00:26:37] Speaker 03:
Pardon me, Your Honor?

[00:26:39] Speaker 02:
I'm talking about just that limitation, the second syringe of Salazzo.

[00:26:45] Speaker 02:
You have to put it somewhere and any of the illustrated compartments in which a second syringe could fit would seem to me to be a very obvious place to locate Salazzo's second syringe.

[00:27:01] Speaker 02:
Am I missing something?

[00:27:03] Speaker 03:
Well, I guess the board found otherwise.

[00:27:06] Speaker 03:
I think the exercise today is on the standard of review.

[00:27:10] Speaker 03:
Was there evidence to support the board's finding that it was not obvious to do that?

[00:27:16] Speaker 03:
We have expert testimony to that effect.

[00:27:19] Speaker 03:
And given the expert testimony, which is substantial,

[00:27:23] Speaker 03:
from really all the experts, but particularly Medline's experts, the board's decision should be sustained on that ground.

[00:27:30] Speaker 02:
I would point out further that... Can you tell me, can you tell me what experts said, any of the experts said in the record that explains why it would be not obvious to put the second syringe in compartment 27?

[00:27:46] Speaker 02:
Well, I... The field artist would not be motivated to locate it there.

[00:27:52] Speaker 03:
On that point, I would refer you to the testimony of Mr. Plitschka and Dr. Yoon, who are BART's experts, who refer to the general nature of the kit of stiletto.

[00:28:05] Speaker 03:
And both of them said, this is the pen of Mr. Plitschka, for example, this is the pen illustration that's teaching certain concepts.

[00:28:13] Speaker 03:
It's not a design drawing showing how something would be made if it was to be put into production.

[00:28:19] Speaker 03:
So we know that there's a,

[00:28:21] Speaker 03:
syringe, the second syringe of stiletto, somewhere in the kit.

[00:28:26] Speaker 03:
It doesn't have to be in the tray.

[00:28:28] Speaker 03:
The kits have been made in the past with separate boxes, with separate components, and is it possible that it could be placed somewhere else?

[00:28:38] Speaker 03:
Could it be placed, for instance, on top of the wrapping of the kit?

[00:28:41] Speaker 03:
Could it be placed in a separate box, as in the Starani reference, separate box from the catheter assembly, which is also a requirement of the claim, 245.

[00:28:51] Speaker 03:
So there are other places where it can go besides in the compartment.

[00:28:56] Speaker 03:
And so the board found that it was not obvious based on the references to put them, you know, one of the skill in the art would not be motivated to put it in a second compartment, or in the same compartment as the other syringe, or syringes in Solasso's case, and with the catheter assembly in a separate compartment.

[00:29:17] Speaker 00:
Mr. Hoover, could you address claim one, and in particular Mr. Matsui's arguments with respect to the first compartment support, the base members support defining a mnemonic device?

[00:29:35] Speaker 03:
Yes, Your Honor.

[00:29:38] Speaker 03:
Bard did not ask for any special construction of that term.

[00:29:42] Speaker 03:
As the patent challenger, it was incumbent upon them to do so.

[00:29:46] Speaker 03:
We did point out, as you noted in our patent owner response, that that is how we were construing the reference.

[00:29:56] Speaker 03:
It was basically that the tray itself is supporting the syringes and defining the monomic device.

[00:30:05] Speaker 04:
In other words, you're saying that a device is simply the shape of the container.

[00:30:13] Speaker 03:
I think it's the tray, Your Honor.

[00:30:15] Speaker 04:
And that's a device.

[00:30:20] Speaker 03:
I don't think that the other component of the argument that Art is making is correct.

[00:30:26] Speaker 04:
The word mnemonic in my understanding means memory.

[00:30:30] Speaker 04:
And that sort of calls for the mental step of thinking that something at a higher level is to be used before an item of a lower level.

[00:30:42] Speaker 04:
That's a very strange claim.

[00:30:46] Speaker 03:
Well, the claim does call for the tray to have the monadic device.

[00:30:54] Speaker 03:
There's nothing in the patent that suggests that if it was stuck on top of other stuff, for example, that it would be somehow a monadic device.

[00:31:09] Speaker 03:
The evidence here is that Celesto does not, in fact, teach the syringes at any particular heights.

[00:31:17] Speaker 03:
The testimony of Dr. Pliska and Dr. Yoon is very much on point on the syringe height of the illustration in Silasso.

[00:31:28] Speaker 03:
Mr. Pliska said, we asked him, well, what are the two lines in the one drawing of Silasso?

[00:31:34] Speaker 03:
And he said, to tell the truth, I'm not 100% sure.

[00:31:38] Speaker 03:
We asked Dr. Yoon where the lubricant was positioned in Silasso.

[00:31:44] Speaker 03:
In Barrett's brief, they refer to this as the Dr. Yoon was

[00:31:50] Speaker 03:
Hoover can hike.

[00:31:51] Speaker 03:
And he says, I don't know if that represents some type of ledge or not.

[00:31:55] Speaker 04:
Mr. Hoover, you won, obviously, in the patent office.

[00:31:59] Speaker 04:
But then you start off your brief by saying the court should affirm for other reasons, that the references are incompatible with each other and that there were secondary considerations that the board didn't consider.

[00:32:15] Speaker 04:
Can you explain why

[00:32:18] Speaker 04:
You didn't start out defending what the board did and you had to look for other reasons to affirm?

[00:32:26] Speaker 03:
Well, I guess, I think the, there's such strong reasons for affirmance on multiple fronts, Your Honor.

[00:32:32] Speaker 03:
It was hard to choose, frankly.

[00:32:34] Speaker 03:
I feel that the stiletto reference describes a tray and the reference teaches that urine and clots are to be dispensed into the tray and

[00:32:47] Speaker 03:
The Silasso tray, therefore, you would not add a bag to it.

[00:32:52] Speaker 03:
And to me, that is very compelling.

[00:32:57] Speaker 03:
I also find the secondary evidence here to be very strong.

[00:33:02] Speaker 03:
It's undisputed that Barr copied the Medline device.

[00:33:06] Speaker 03:
They praised it.

[00:33:07] Speaker 03:
They called it innovative.

[00:33:09] Speaker 03:
And so he thought that that was evidence the court should hear.

[00:33:16] Speaker 03:
Nonetheless, on the factual findings, they are also very strong.

[00:33:22] Speaker 03:
On this issue of the height of the syringes, all four technical experts agree that the Sulatso reference doesn't show that feature.

[00:33:34] Speaker 03:
And so on just the basis that the board did decide that that particular feature is not

[00:33:43] Speaker 03:
found in Silasso, and it's not found in the other references either.

[00:33:50] Speaker 03:
I'd like to discuss, if I might, the lubricating jelly application chamber.

[00:33:56] Speaker 03:
We have evidence from our expert, Ms.

[00:33:59] Speaker 03:
Chiappetta, that the Silasso tray was not useful for lubrication.

[00:34:05] Speaker 03:
The Cabri Test 27, the compartment that Silasso shows is too deep.

[00:34:10] Speaker 03:
And she says if you put lubricant there, the purpose of the salato tray, again, is to dispense urine and clots.

[00:34:17] Speaker 02:
Mr. Hoover?

[00:34:19] Speaker 02:
Mr. Hoover, this is Judge Chen.

[00:34:22] Speaker 02:
When I look at compartment 27, there's this question of whether it's too deep so that you could lubricate the tip of a catheter.

[00:34:35] Speaker 02:
And I guess what I'm wondering is, why is it too deep?

[00:34:39] Speaker 02:
I mean, why can't you just

[00:34:41] Speaker 02:
you know, dip the catheter down into that compartment until the tip reaches where the jelly is.

[00:34:54] Speaker 02:
And like a French fry, you've, with ketchup, you've dipped the tip of the catheter into the jelly.

[00:35:01] Speaker 03:
Well, this is the medical procedure, and this is done in a fairly high volume.

[00:35:10] Speaker 03:
in hospitals in the emergency room setting, for example, where things are very stressful.

[00:35:16] Speaker 03:
And Ms.

[00:35:19] Speaker 03:
Ciapetta did find that it was not really sized for that.

[00:35:25] Speaker 03:
Could somebody make it work?

[00:35:28] Speaker 03:
I guess probably so in your French fry analogy.

[00:35:31] Speaker 03:
But the use of the device is in the hospital-type setting.

[00:35:37] Speaker 03:
care you were setting and the compartment was deemed to be too deep.

[00:35:41] Speaker 03:
That's the evidence, among the evidence that Ms.

[00:35:45] Speaker 03:
Chiappetta presented.

[00:35:47] Speaker 02:
I understand you have an expert that said that.

[00:35:49] Speaker 02:
I'm really trying to understand why is it too deep?

[00:35:53] Speaker 02:
Why is it unusable?

[00:35:55] Speaker 02:
Is it something about the claim language itself that requires structurally a, I don't know, a shallow well or compartment as opposed to something

[00:36:07] Speaker 02:
a little deeper like compartment 27.

[00:36:10] Speaker 03:
I don't think that celestial compartment 27 with the wall that's shown would allow a user to reach one's hand in there to lubricate the catheter.

[00:36:23] Speaker 03:
And could you sort of shove the catheter down in there?

[00:36:27] Speaker 03:
That's not really conducive to how a medical procedure should be performed.

[00:36:31] Speaker 02:
Well, how do we understand, then, your claim?

[00:36:36] Speaker 02:
I mean, to me,

[00:36:38] Speaker 02:
You know, if I could use compartment 27 as a ketchup well for my French fry, what is it about your claim term about a compartment configured to receive lubrication jelly to lubricate the catheter tip as somehow forcing me to understand that we're talking about a very shallow well?

[00:37:06] Speaker 03:
Is that your question?

[00:37:08] Speaker 02:
I guess is what I'm trying to understand.

[00:37:09] Speaker 02:
What is your conception of what that claim term means?

[00:37:13] Speaker 03:
I think it means a place where lubricant is dispensed in the use of the kit.

[00:37:20] Speaker 03:
The Chiapetta and Dr. Singh testified additionally that in the Silasso tray, Chiapetta said that in the Silasso tray.

[00:37:30] Speaker 02:
Mr. Hoover, Mr. Hoover, Mr. Hoover, you keep referring to Silasso.

[00:37:35] Speaker 02:
Right now, I'm asking you a different question, which is what is your understanding of what the claim actually requires?

[00:37:41] Speaker 02:
Don't talk about Salasso.

[00:37:43] Speaker 02:
Put Salasso away.

[00:37:45] Speaker 02:
Let's just talk about what your claim means and how a skilled artist would understand it as a structural matter.

[00:37:53] Speaker 02:
What is the structure of the compartment for receiving the lubrication jelly that requires it to be,

[00:38:04] Speaker 02:
something that's not too deep.

[00:38:06] Speaker 03:
I think it must be suitable for receiving lubricants when used in the catheterization procedure.

[00:38:16] Speaker 02:
And what does suitable mean?

[00:38:19] Speaker 03:
I think the user must be able to lubricate the catheter effectively in that compartment.

[00:38:32] Speaker 02:
OK.

[00:38:34] Speaker 02:
Explain to me, one person to another, what is it about compartment 27 that makes a person unable to use that well as a place to lubricate a catheter tip?

[00:38:54] Speaker 03:
As Ms.

[00:38:55] Speaker 03:
Ciapetta explained, that well is where urine and clots go in the falafel device when

[00:39:04] Speaker 03:
You categorize a patient.

[00:39:08] Speaker 03:
You often need to measure the urine output.

[00:39:11] Speaker 03:
You need to evaluate the urine.

[00:39:13] Speaker 02:
You need to sometimes... Putting that to the side, putting that to the side, I'm talking more about the structure of compartment 27 and how it is configured.

[00:39:25] Speaker 02:
As a structural matter, you're telling me it's not configured to receive jelly

[00:39:33] Speaker 02:
to lubricate the catheter tip?

[00:39:38] Speaker 03:
I refer, Your Honor, to, I believe it's the Giannelli case, where there were handles in the exercise machine, and they're configured for pushing.

[00:39:49] Speaker 03:
And the prior art had handles, and they were configured for pulling in that particular machine, in that embodiment.

[00:39:57] Speaker 03:
So they're just handles.

[00:39:59] Speaker 03:
So you could say, well, any handles, you could push or pull them.

[00:40:02] Speaker 03:
But the court said, no.

[00:40:04] Speaker 03:
In the prior art, they were not configured for pushing, I think it was, because the machine was expressly designed for pulling, and you couldn't be used for pushing.

[00:40:13] Speaker 03:
I think this is the case on that front.

[00:40:16] Speaker 03:
Is it a plastic surface of a tray?

[00:40:19] Speaker 03:
Yes.

[00:40:19] Speaker 03:
Could lubricant be placed on a plastic surface of a tray as a general matter?

[00:40:25] Speaker 03:
Of course.

[00:40:26] Speaker 03:
In Celasto, in a lubrication jelly application chamber, absolutely not.

[00:40:32] Speaker 03:
for the reasons given by the experts and in the same order as this Gianelli case with the handles.

[00:40:41] Speaker 03:
I think you have to look at the context of the reference and what the reference is teaching you to do, not simply at is there a plastic surface that lubricant would rest on.

[00:41:03] Speaker 03:
But that's OK, Your Honor.

[00:41:04] Speaker 03:
If I move to the 596 and the drainage bag and the orientation thereof?

[00:41:14] Speaker 04:
Sure.

[00:41:15] Speaker 04:
Please, please.

[00:41:18] Speaker 03:
Yes.

[00:41:20] Speaker 03:
Again, we hear from Bard in his briefing and an argument today that there was a surprise plane construction.

[00:41:26] Speaker 03:
Again, that is also not correct.

[00:41:29] Speaker 03:
Bard, who is in Congress,

[00:41:33] Speaker 03:
under the board rules to have prevented any particular claim construction that is but deviated from, I guess, the plain meaning of the terms.

[00:41:42] Speaker 03:
The evidence shows that the Starani reference doesn't meet that claim limitation.

[00:41:52] Speaker 03:
It shows the catheter going around the bag and not on top of the bag.

[00:41:56] Speaker 03:
And it's not really positioned for the immediate use as it is in the Medline patent.

[00:42:03] Speaker 03:
And so I don't believe Bard is correct either as a legal matter or on the facts.

[00:42:09] Speaker 03:
The board found facts that the surrounding reference doesn't show that feature.

[00:42:15] Speaker 03:
And given that, that was the only reference that Bard relied on for that feature.

[00:42:22] Speaker 03:
Those claims are sustainable on that basis as well, independently of the two syringes.

[00:42:32] Speaker 03:
I'd like to talk, Mike, Your Honor, about the MI reference as well.

[00:42:37] Speaker 03:
We've heard a lot from Barr about the MI reference.

[00:42:43] Speaker 03:
I guess one point is that they didn't put the MI reference in the challenge grounds, but I understand it's in the records, so the court can consider it.

[00:42:52] Speaker 03:
But we do have evidence from our expert, Dr. Singh, that the MI reference is not relevant.

[00:42:58] Speaker 03:
And in the 109 IPR, the

[00:43:01] Speaker 03:
board expressly credited that declaration and discounted the opinion of barge experts.

[00:43:09] Speaker 03:
That's happened in quite a lot of these proceedings.

[00:43:11] Speaker 03:
But why is MI relevant?

[00:43:13] Speaker 03:
The board found that MI was not relevant because it talks about a completely different procedure.

[00:43:19] Speaker 03:
In another one of the proceedings, the board found that the MI reference was schematic in nature, wasn't really showing you a specific structure.

[00:43:28] Speaker 03:
Now, one of the points that Bart makes is that in the 36 IPR, I believe, that the board didn't discuss MI, so therefore there must be an error.

[00:43:38] Speaker 03:
Well, in the other 35 IPRs decided the same day, and in the other IPRs decided on the same references, the board did discuss MI and did distinguish it and differentiate it.

[00:43:49] Speaker 03:
So the fact that they did not mention it in one of two IPR decisions decided on the same day is not a basis to reverse.

[00:44:00] Speaker 02:
Could you talk about the various potential issue preclusion issues here?

[00:44:05] Speaker 02:
Let's assume for the moment we have to send some of these claims back to the board.

[00:44:13] Speaker 02:
And the other side has made an argument that there's no need to consider any of the secondary consideration evidence.

[00:44:23] Speaker 02:
Moreover, there's no need to consider your arguments about motivation to combine

[00:44:31] Speaker 02:
with a drainage bag because there's issue preclusion there given an already final board proceeding, as well as replacing the lubrication tube with a lubrication syringe.

[00:44:50] Speaker 03:
Certainly.

[00:44:51] Speaker 03:
I'll tackle them in that order.

[00:44:55] Speaker 03:
On the secondary considerations, as we indicated in our brief,

[00:44:59] Speaker 03:
uh... the board didn't make necklaces findings on essentially all of the secondary considerations that we uh... presented there are hundreds and hundreds of millions of dollars of sales of these products we put in evidence tying that to these claims people buy the product because they really like it not because of other reasons we put in evidence of copying we put in evidence uh... praise barred call the headline product innovative

[00:45:28] Speaker 03:
The board didn't reach that.

[00:45:29] Speaker 03:
The board didn't reach that in the other IPR for the 400 patent.

[00:45:34] Speaker 03:
They didn't explain why they didn't reach it.

[00:45:36] Speaker 03:
I think there's one issue that the board did decide against MEDLINE and only one on the secondary considerations, which was that MEDLINE had not proved that the kit itself was the sole cause of the decline of calcium rates in the out.

[00:45:55] Speaker 03:
And I would say that that's an issue that we'd be precluded on.

[00:45:59] Speaker 03:
On the issue of the motivation to combine, we did, as the court has noted, lead with that.

[00:46:09] Speaker 03:
11 days after we filed our brief, this court decided the Sting Court case, which Barb helpfully cites in its brief, that case goes against us.

[00:46:20] Speaker 03:
And so we're going to drop that issue for this appeal.

[00:46:24] Speaker 03:
on the motivation to substitute a lubricant packet for a syringe in the cilantro reference.

[00:46:33] Speaker 03:
We didn't contest that below.

[00:46:37] Speaker 00:
Mr. Hoover, I missed what the issue was, again, that you said you were dropping for this appeal.

[00:46:45] Speaker 03:
I think that we have argued

[00:46:49] Speaker 03:
And the sole issue that we will drop for this appeal is adding a bag to the salato reference.

[00:47:03] Speaker 03:
Bob has said that we are precluded because we didn't appeal the 400 patent.

[00:47:08] Speaker 03:
And so could somebody use the salato reference with a bag?

[00:47:14] Speaker 03:
We don't feel that that's a correct

[00:47:17] Speaker 03:
position for the reasons we stated, but the board held against us on that issue, and that issue was not a factor in any of the four IPRs that we are here on today.

[00:47:29] Speaker 03:
The board did not agree with us in any of those proceedings that it was, you know, adding a bag to palazzo was somehow a factor.

[00:47:38] Speaker 03:
What the board did do was find that other features of our claims were absent from all of the references

[00:47:44] Speaker 03:
The board weighed evidence, decided credibility issues, agreed with Dr. Singh, agreed with Ms.

[00:47:50] Speaker 03:
Chiappetta, disagreed with Bar's experts on a number of occasions, discounted their testimony, and Bar's appeal today is predicated on asking the court to re-weigh that evidence in large part.

[00:48:03] Speaker 03:
But with that, Your Honor, I think I'm out of time.

[00:48:06] Speaker 03:
Unless the court has further questions, I would like to pass back to Bar's counsel.

[00:48:14] Speaker 04:
I don't hear any further questions.

[00:48:16] Speaker 04:
Thank you, Mr. Hoover, Mr. Matsu.

[00:48:18] Speaker 04:
We have some rebuttal time.

[00:48:21] Speaker 01:
Thank you, Your Honor.

[00:48:22] Speaker 01:
So I'd like to start briefly with the two syringes in one compartment limitation.

[00:48:28] Speaker 01:
Our experts explained at Appendix 1395 that the two possibilities basically were Compartment 3 or Compartment 27.

[00:48:40] Speaker 01:
There was never any discussion that I'm aware of of storing

[00:48:44] Speaker 01:
the syringe outside of the tray itself, and so you're dealing with a finite number of predictable places in which you could put that second syringe for Solazo.

[00:48:55] Speaker 01:
With respect to the drainage bag, it's very similar.

[00:48:58] Speaker 01:
You have a drainage bag positioned between the foley catheter and the tray bottom.

[00:49:04] Speaker 01:
There really only are a couple places that you could put the catheter.

[00:49:08] Speaker 01:
You could either put it basically underneath the

[00:49:11] Speaker 01:
the drainage bag.

[00:49:13] Speaker 01:
You could put it on top of the drainage bag.

[00:49:14] Speaker 01:
I suppose you could put it around the drainage bag.

[00:49:16] Speaker 01:
But in those last situations, you're going to have a situation where the drainage bag is positioned between the foley catheter and the tray bottom.

[00:49:24] Speaker 01:
There's, again, just a finite number of predictable solutions in which a person of ordinary skill in the art could figure out where to position these various items within a tray.

[00:49:33] Speaker 01:
And then when you look at a prior reference like Distin at Appendix 33,

[00:49:39] Speaker 01:
of the 596 appeal, where you have the bag that's flat on the tray bottom itself.

[00:49:48] Speaker 01:
Given the fact that you basically want to have these trays so they're ready to use, so you can use them in the order in which the items are going to be used, the only logical place in which you would put the catheter is on top of the fluid receptacle bag.

[00:50:05] Speaker 01:
With respect to the lubricant compartments,

[00:50:08] Speaker 01:
The claim language here is just the first compartment is configured to receive lubricating jelly.

[00:50:15] Speaker 01:
There's nothing that would indicate any sort of shallow structure or any sort of any additional types of requirements.

[00:50:22] Speaker 01:
Again, these are apparatus claims.

[00:50:24] Speaker 01:
They're not method claims.

[00:50:26] Speaker 01:
So all that matters is that you have the structure.

[00:50:28] Speaker 01:
And with respect to Salazzo's Compartment 27, Nurse Chiapetta basically said at appendix

[00:50:37] Speaker 01:
10-936, and this is in the 5-9-6 appeal, that she criticized Salazzo's central compartment as relatively deep.

[00:50:46] Speaker 01:
But then her conclusion at the bottom was that clinicians are more likely to use an open flat space.

[00:50:53] Speaker 01:
So it's not that they're not going to be used.

[00:50:55] Speaker 01:
It's not configured to receive lubricating jelly.

[00:50:59] Speaker 01:
It's just that they're more likely to use a shallow

[00:51:02] Speaker 01:
So, again, you have Solazo that meets the requirement, the broad requirement here, that it's just configured to receive lubricating jelly.

[00:51:13] Speaker 00:
Mr. Matsui, if I... Go ahead.

[00:51:16] Speaker 00:
Mr. Matsui, if... In your view, what would you consider to be a chamber that would not be configured to accept lubrication for purposes of lubricating the...

[00:51:31] Speaker 00:
the tip of the catheter.

[00:51:35] Speaker 00:
I'm not entirely certain what type of chamber wouldn't be configured to receive... Well, that's my problem is you seem to be saying basically anything would qualify to satisfy this limitation.

[00:51:45] Speaker 00:
If you can give me an example of something that you would agree would not qualify, I would be interested in hearing what it is.

[00:51:52] Speaker 01:
I mean, one could imagine that there could be a container that could be shaped a certain way that would prevent

[00:51:58] Speaker 01:
the actual catheter to get into it.

[00:52:01] Speaker 01:
We're thinking about these trays fully in the context of them being dipped down with basically compartments that go straight down, but one can imagine a tray that would have situations where the compartment goes off to a side in which you could not put the catheter actually to fit inside that compartment.

[00:52:21] Speaker 01:
But here we have a situation.

[00:52:23] Speaker 01:
I don't think the court needs to address that type of hypothetical because

[00:52:28] Speaker 01:
Here we have a trade that clearly is configured to receive.

[00:52:33] Speaker 02:
Mr. Matsui, what if compartment 27 in Slazo was 12 inches deep?

[00:52:40] Speaker 02:
Would that be too deep?

[00:52:43] Speaker 01:
I don't think it would, Your Honor, because catheters themselves are very long.

[00:52:48] Speaker 01:
And so I think that certainly at some point you could get to a situation where

[00:52:54] Speaker 01:
a catheter just would not be able to reach the bottom of the tray, but I don't think 12 inches might accomplish that.

[00:53:01] Speaker 02:
And then finally, what do you have to say about what the board said, which was, well, the way Solazo is designed, compartment 27 has nothing to do with receiving jelly.

[00:53:17] Speaker 02:
That's where wells 31 and 33, that's

[00:53:22] Speaker 02:
where Slazo describes and discloses the place to squeeze out the lubrication jelly.

[00:53:29] Speaker 02:
And compartment 27 is all about the urine overflow and things like that.

[00:53:36] Speaker 02:
So that would probably be one of the very last places where you would squeeze out some lubrication jelly.

[00:53:45] Speaker 02:
So can you describe, can you respond to that?

[00:53:47] Speaker 01:
Yeah, I mean, our experts explained that clinicians would put lubricating jelly in lots of different compartments.

[00:53:54] Speaker 01:
And again, we're talking sort of more, the board's conclusion there is talking more about how the tray would actually be used by actual clinicians, not what the structures of the tray themselves are.

[00:54:07] Speaker 01:
And since these are apparatus claims, the mere fact that they have these structures is enough for the claims to, the claims would have been obvious.

[00:54:18] Speaker 01:
And I understand my time has expired.

[00:54:20] Speaker 01:
If there are no further questions, we would ask that the court reverse the board.

[00:54:26] Speaker 04:
Thank you, counsel.

[00:54:28] Speaker 04:
We appreciate the arguments of both counsel and the cases submitted.