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

[00:00:04] Speaker 04:
We have four RU cases this morning.

[00:00:07] Speaker 04:
The first is number 17 and 1193 Nestle USA, Inc.

[00:00:12] Speaker 04:
versus Steuben Foods, Inc.

[00:00:15] Speaker 04:
This is Karen.

[00:00:16] Speaker 04:
And I think since the second case involves the same counsel, I suggest you just keep the same places at the table rather than switching.

[00:00:31] Speaker ?:
OK?

[00:00:31] Speaker 00:
Yes, Sean.

[00:00:31] Speaker 00:
May I please the court?

[00:00:32] Speaker 00:
Virginia Carroll on behalf of

[00:00:34] Speaker 00:
Appellant Nestle USA.

[00:00:36] Speaker 00:
The central issue in this appeal has been before this court before, and that is the construction and scope of the term aseptic and aseptically disinfecting as found in the patent at issue in this appeal, as well as the patent that was at issue before, the 013 patent in this court's matter 2016-1750.

[00:00:56] Speaker 00:
The court, that decision, the decision of the court came out after Nestle's blue brief, but before the other two briefs.

[00:01:04] Speaker 00:
and was addressed in both of those briefs.

[00:01:07] Speaker 00:
That decision reversed the board's finding, the board's claim construction of aseptic and affirmatively entered a claim construction that aseptic in that patent, which has the same specification and file history as to the term aseptic and aseptically disinfecting, that aseptic is based on the lexicography in the patent defined as the FDA level of aseptic.

[00:01:33] Speaker 00:
The court went further in looking at the scope of the claim term and confined the FDA level of aseptic to FDA regulations related to aseptic packaging.

[00:01:44] Speaker 00:
It specifically considered argument that the FDA level of aseptic included the FDA's hydrogen peroxide residual restriction and determined that it did not.

[00:01:59] Speaker 00:
It found that

[00:02:01] Speaker 00:
Only the regulations that were aseptic were included in the FDA level of aseptic, not regulations that applied to food products that were not aseptic.

[00:02:13] Speaker 00:
The court's analysis and its ruling that the residual is not a finding of fact.

[00:02:21] Speaker 00:
It is a matter of claim construction that this court has already resolved.

[00:02:24] Speaker 00:
The court considered specifically the claims and found that, based on claim differentiation,

[00:02:31] Speaker 00:
The patentee had clearly, when it wished to claim the hydrogen peroxide residual requirement, it did so specifically.

[00:02:38] Speaker 00:
And when it did not, it did not.

[00:02:40] Speaker 00:
And thus, that supported its finding that the hydrogen peroxide residual was not part of the definition of aseptic.

[00:02:50] Speaker 01:
Councilor, what collateral estoppel effect, if any, does our prior ruling have on this?

[00:03:02] Speaker 00:
Well, Your Honor, because it is a different patent, although a related patent, and the specification and the file history are the same, we would assert that your findings, your ruling of claim construction in that proceeding is binding on this proceeding.

[00:03:18] Speaker 00:
Unless there is error or new evidence or some other vases to revisit that claim construction, we do not believe that that has been asserted or shown in this case.

[00:03:27] Speaker 04:
One of the claim terms is different, I think.

[00:03:29] Speaker 04:
One is the same aseptic

[00:03:32] Speaker 04:
and the other one's aseptically disinfecting, which I think, if I recall correctly, was not a claim term that was an issue in the earlier appeal.

[00:03:43] Speaker 00:
Well, it was an issue in the earlier appeal in the sense that the court, I mean, the board and the court looked at the word aseptic.

[00:03:49] Speaker 04:
Right, I understand that.

[00:03:50] Speaker 04:
But that particular terminology was not an issue in the earlier appeal.

[00:03:55] Speaker 04:
Has anybody suggested here

[00:03:57] Speaker 04:
that the term aseptic and aseptically disinfecting could have different meanings?

[00:04:04] Speaker 00:
No, Your Honor.

[00:04:05] Speaker 00:
In fact, nobody has challenged the court's construction that aseptic means FDA level of the aseptic, or that the FDA level of the aseptic means the FDA standards that relate to aseptic packaging.

[00:04:19] Speaker 04:
Well, I'm not sure that's true.

[00:04:20] Speaker 04:
Your opposing counsel seems to think that the earlier decision was wrong.

[00:04:27] Speaker 00:
Well, opposing counsel has asserted that the hydrogen peroxide residual is an aseptic standard, is an aseptic regulation.

[00:04:40] Speaker 00:
But opposing counsel, based on the briefs, has not challenged this court's construction of aseptic, except for it has asserted that the court should not have concluded that the hydrogen peroxide residual does not meet its construction.

[00:04:57] Speaker 00:
But it hasn't challenged the underlying construction, at least based on the briefs before this court.

[00:05:04] Speaker 00:
The assertion is that this court shouldn't have found that, as I understand it, opposing counsel asserts that this court should not have concluded that the residual requirement is not an aseptic standard.

[00:05:16] Speaker 00:
That is, they assert that it is an aseptic standard.

[00:05:19] Speaker 00:
But the court went through that analysis and made that claim construction affirmatively by looking at the claims based on claim differentiation.

[00:05:26] Speaker 02:
Is that really a claim construction issue?

[00:05:28] Speaker 02:
I mean, I tend to agree with you that they're not challenging the claim construction that aseptic means FDA standards of aseptic, but whether or not the regulation itself, the residual regulation, 21, 1005, I think, is an aseptic standard or not, is that really a claim construction issue or is that our interpretation of what 1005 is for?

[00:05:57] Speaker 00:
Your honor, it is claim construction.

[00:05:59] Speaker 00:
It was necessary to reach the conclusion in this case, but the board and APLI asserted that it met the definition of a standard that should be applied.

[00:06:10] Speaker 02:
But if we just got it wrong, and 1005 actually is the only point of the residual regulation is the use of hydrogen peroxide in aseptic systems and sterilization.

[00:06:25] Speaker 02:
Wouldn't it then be an aseptic regulation under our construction?

[00:06:32] Speaker 00:
If Your Honor concluded that the regulation, after looking at the specification, the file history and the regulation... See, this is where I'm a little confused by your argument.

[00:06:42] Speaker 02:
Now, I don't think it... I'm not sure it really matters much because I'm not sure that we got it wrong, but I don't know why it's a claim construction issue of what the regulation is.

[00:06:52] Speaker 02:
The claim construction is what they mean that term aseptic processing to be or aseptic.

[00:06:58] Speaker 02:
We said that means FDA regulations relating to it.

[00:07:01] Speaker 02:
Then we have to look at FDA regulations and put them in certain boxes, but that's not claim construction.

[00:07:06] Speaker 02:
That's construing what regulations are for.

[00:07:09] Speaker 02:
So why is it 1005 just used for aseptic processing?

[00:07:18] Speaker 00:
Your question has two parts, as I understand it.

[00:07:20] Speaker 00:
And the first is, why isn't it really climate construction, or is it?

[00:07:24] Speaker 02:
Why don't you just get past that?

[00:07:25] Speaker 02:
Because you're kind of wasting your time with me.

[00:07:27] Speaker 02:
My point is, if you read 1005 in its entirety, doesn't it lead you to the conclusion that it actually is, the whole point of that is, the residuals of hydrogen peroxide when it's used as a sterilant and aseptic processing systems?

[00:07:46] Speaker 00:
No, Your Honor.

[00:07:46] Speaker 00:
It does not.

[00:07:48] Speaker 00:
Looking at the history of the regulation and the regulation itself, it clearly applies to all food processing that uses hydrogen peroxide.

[00:07:55] Speaker 02:
And what's your evidence for that?

[00:07:57] Speaker 02:
Is it on the text of the regulation?

[00:08:00] Speaker 00:
The text of the regulation, but also on the legislative history of the regulation.

[00:08:05] Speaker 00:
The regulation sprung from the fact that the FDA was going to permit the use of hydrogen peroxide in food processing, and it realized that exposure

[00:08:17] Speaker 00:
to hydrogen peroxide by humans could cause health and safety concerns.

[00:08:21] Speaker 00:
And so it needed to limit how much hydrogen peroxide could come in contact with the food product and thus be ingested by a human.

[00:08:29] Speaker 00:
And it determined, based upon a number of studies and analysis, that that was a safe level of ingestion by human beings of hydrogen peroxide that would be left as a residual in the processing of the packaging material in the food and then combined and ingested.

[00:08:47] Speaker 02:
But I think your friend suggests that the whole impetus for this regulation was to be used in an aseptic processing system.

[00:08:56] Speaker 02:
And that's the question that the FDA was addressing.

[00:08:59] Speaker 02:
Is that incorrect?

[00:09:00] Speaker 00:
Well, there's no evidence that that's the reason that that was the impetus for this regulation.

[00:09:04] Speaker 02:
Well, isn't that who asked for the regulation, an aseptic processor?

[00:09:10] Speaker 00:
That is not in the record.

[00:09:12] Speaker 00:
There's no evidence of that in the record.

[00:09:14] Speaker 00:
That has been suggested by Posing Council.

[00:09:17] Speaker 00:
There is nothing to suggest that in the legislative history or the records of the government that support the FDA regulation.

[00:09:25] Speaker 00:
Perhaps there was an impetus there, but it's clear and there is evidence that that standard applies to non-aseptic processing.

[00:09:34] Speaker 02:
What's that evidence?

[00:09:40] Speaker 02:
Is it that the regulation on its face doesn't confine it to aseptic processing?

[00:09:46] Speaker 02:
Or is it, I mean you say the legislative history, but you're not pointing me to anything specific.

[00:09:53] Speaker 00:
I can point you to something specific, Your Honor.

[00:10:01] Speaker 00:
The regulation on its face is not limited to aseptic processing.

[00:10:03] Speaker 00:
The only use of the word aseptic in the whole regulation is in Subsection E, which talks about

[00:10:08] Speaker 00:
the fact that if hydrogen peroxide is going to be used for aseptic processing, it must also comply with all the other subsections of that regulation, which include the maximum amount of percentage of hydrogen peroxide and the residual requirement.

[00:10:24] Speaker 00:
So the application of that requirement to aseptic is provided for in E, subsection E, as long as the remaining provisions are complied with.

[00:10:35] Speaker 00:
The remaining provisions applied

[00:10:36] Speaker 00:
all food processing using hydrogen peroxide, not just aseptic.

[00:10:40] Speaker 04:
I guess they could hardly have intended that if you don't use aseptic processing that you can still exceed the hydrogen peroxide level specified in the regulation.

[00:10:52] Speaker 00:
I'm sorry.

[00:10:53] Speaker 04:
The FDA could hardly have intended that if you didn't use aseptic processing that you could exceed the hydrogen peroxide levels.

[00:11:03] Speaker 04:
In other words, that you could poison people if you weren't using aseptic processing.

[00:11:09] Speaker 00:
Well, Your Honor, there had been an existence for a long time before aseptic processing, other types of food processing that it did use hydrogen peroxide.

[00:11:15] Speaker 04:
That's the point.

[00:11:16] Speaker 04:
Why would the FDA allow you to have larger concentrations of hydrogen peroxide when you weren't using aseptic processing?

[00:11:28] Speaker 00:
Because there are instances where the use of hydrogen peroxide levels.

[00:11:31] Speaker 04:
I don't know why you're fighting this.

[00:11:39] Speaker 00:
I'm not sure how to respond.

[00:11:42] Speaker 02:
Well, I think the point is that this is a regulation that applies to all kinds of food processing, not just aseptic processing.

[00:11:51] Speaker 02:
And the FDA met one standard to apply to everything, not just for this to apply to aseptic.

[00:11:58] Speaker 02:
and not to have a limitation on other food processing.

[00:12:03] Speaker 02:
I take it you would agree.

[00:12:05] Speaker 00:
Yes, Your Honor.

[00:12:06] Speaker 00:
That's right.

[00:12:06] Speaker 00:
I'm sorry.

[00:12:06] Speaker 00:
I think I misunderstood what you were saying.

[00:12:08] Speaker 00:
I apologize.

[00:12:12] Speaker 04:
All right, Chair.

[00:12:13] Speaker 04:
Enter your rebuttal.

[00:12:14] Speaker 04:
Do you want to save it?

[00:12:20] Speaker 04:
Yes, please.

[00:12:22] Speaker 04:
Mr. Fisher.

[00:12:24] Speaker 03:
Good morning.

[00:12:25] Speaker 03:
Please, the court.

[00:12:27] Speaker 03:
I think I'll pick up where we left off here with respect to the regulatory regime here.

[00:12:35] Speaker 02:
Can I just ask you, because I find your red brief a little confusing on this point.

[00:12:41] Speaker 02:
And I know that our decision came out in the midst of briefing, but you had it there.

[00:12:47] Speaker 02:
Do you agree that in that decision, we said that the hydrogen peroxide regulation

[00:12:57] Speaker 02:
is not an aseptic regulation.

[00:13:01] Speaker 02:
Yes, I agree that... So if it's not an aseptic regulation, and our claim construction of these terms only says that only FDA regulations that apply to aseptic processing are included, then the board's claim construction here is wrong, unless you convince us that our prior decision is wrong.

[00:13:27] Speaker 02:
I mean, that convoluted way of saying, if we apply the claim construction and the content of our prior decision, we have to vacate and remand here too.

[00:13:37] Speaker 03:
That's not necessarily correct, Your Honor.

[00:13:39] Speaker 03:
How could that not be correct?

[00:13:40] Speaker 03:
So we have a different patent here, we have a different claim term here.

[00:13:43] Speaker 03:
It's a related patent, isn't it?

[00:13:45] Speaker 03:
It's a related patent.

[00:13:46] Speaker 03:
The claim term that was construed in the 1750 appeal was aseptic.

[00:13:52] Speaker 03:
was lexicographically defined as FDA level of aseptic.

[00:13:59] Speaker 03:
And what this court decided in the 1750 appeal is that would implicate those FDA regulations related to or governing aseptic packaging.

[00:14:14] Speaker 04:
The claim term here.

[00:14:15] Speaker 04:
And it said that this regulation about the hydrogen peroxide residuals was not one of those regulations.

[00:14:21] Speaker 04:
That's correct.

[00:14:21] Speaker 04:
And I'd like to come back to that.

[00:14:23] Speaker 04:
In that binding, too?

[00:14:26] Speaker 03:
With respect, I'd like to move to what?

[00:14:28] Speaker 03:
Is that binding?

[00:14:30] Speaker 03:
With respect to aseptic, perhaps.

[00:14:33] Speaker 03:
If it's correct, it would be binding.

[00:14:35] Speaker 03:
With respect to aseptic.

[00:14:36] Speaker 04:
If it's correct, it would be binding.

[00:14:38] Speaker 04:
Why is it?

[00:14:39] Speaker 04:
Yes, it's binding.

[00:14:40] Speaker 04:
OK, it's binding.

[00:14:43] Speaker 02:
Do you think a regulation can be not an aseptic regulation, but can be an aseptic processing regulation?

[00:14:53] Speaker 03:
No, so I'm going to step back for a second and discuss the regulatory regime.

[00:15:00] Speaker 02:
Well, we said that this was not an FDA regulation related to aseptic, right?

[00:15:09] Speaker 03:
Yes, you did.

[00:15:11] Speaker 02:
And if it's not an FDA regulation related to aseptic, then you lose here unless you can convince us that either we were wrong or that aseptic processing means something different than aseptic.

[00:15:26] Speaker 02:
Correct.

[00:15:27] Speaker 02:
I assume that's what you're relying on.

[00:15:28] Speaker 03:
I would like to convince you both that you are wrong and that aseptically disinfecting can implicate different things than aseptic or aseptic product.

[00:15:38] Speaker 02:
That would still

[00:15:40] Speaker 02:
require us to assume that the hydrogen peroxide regulation is only related to aseptic processing and not just a limitation on hydrogen peroxide residuals, wouldn't it?

[00:15:55] Speaker 02:
That's correct.

[00:15:55] Speaker 02:
Because that's the basis for our decision.

[00:15:57] Speaker 03:
That's correct.

[00:15:58] Speaker 02:
And so is that what you're trying to get at in the regulatory history to show us that 1005 is only an aseptic processing regulation?

[00:16:07] Speaker 03:
Yes.

[00:16:07] Speaker 03:
178.10.

[00:16:08] Speaker 02:
Where in the text of the regulation does it say that?

[00:16:12] Speaker 03:
It says that.

[00:16:13] Speaker 03:
And this is with respect to the preamble.

[00:16:19] Speaker 03:
Where are you reading from?

[00:16:20] Speaker 03:
I'm reading from 178.10.05.

[00:16:21] Speaker 03:
But where is it set for?

[00:16:24] Speaker 03:
Is it in the brief?

[00:16:25] Speaker 03:
Oh, it's in the... I'll just pull up the appendix here.

[00:16:36] Speaker 03:
So in the appendix at 2909.

[00:16:38] Speaker 03:
I would just for a moment like to give a bit of a backdrop here.

[00:17:03] Speaker 03:
It is our understanding that in the 1750 appeal,

[00:17:07] Speaker 03:
We did not undertake a regulatory construction.

[00:17:10] Speaker 03:
We didn't go through the details of what the regulatory legislative history of this regulation was.

[00:17:17] Speaker 03:
The statutory authority for these regulations, we didn't do that level of analysis.

[00:17:22] Speaker 03:
With that level of analysis, had we done that level of analysis, I think we would have found that 178.10.05 issued out of 21 USC 348,

[00:17:32] Speaker 01:
which is a statute that says you can... You can't re-argue the prior case.

[00:17:37] Speaker 03:
No, I want to give the framework of what 178.1005 is.

[00:17:41] Speaker 03:
178.10... Why aren't you re-arguing the prior case?

[00:17:44] Speaker 04:
I'm sorry?

[00:17:45] Speaker 04:
The prior case characterized this regulation as not limited to aseptic processing, right?

[00:17:53] Speaker 03:
That's correct.

[00:17:54] Speaker 03:
Well, so how can we depart from that?

[00:17:59] Speaker 03:
As Judge Hughes suggested, if I could convince you that that decision that it was not an aseptic regulation is wrong, which I would like to do, then we have a different result.

[00:18:08] Speaker 04:
So we're supposed to overrule the earlier case?

[00:18:11] Speaker 03:
No, I think that there can be a consistent construction both in the other case and in this case.

[00:18:15] Speaker 04:
I don't understand what you're talking about.

[00:18:17] Speaker 04:
The other case rejected your position, and now you're saying that we should disregard the earlier case.

[00:18:25] Speaker 02:
Are you asking for a different construction

[00:18:29] Speaker 02:
of aseptically sanitizing versus... Aseptically disinfecting.

[00:18:33] Speaker 02:
Disinfecting, sorry.

[00:18:36] Speaker 03:
Yes.

[00:18:37] Speaker 02:
Aseptically disinfecting is... That's not what the board said below, right?

[00:18:42] Speaker 02:
The board just relied on its same construction from the 1750 case.

[00:18:46] Speaker 03:
The board said that you determine which regulations apply in the context of what is being claimed.

[00:18:53] Speaker 03:
The 1750 appeal was as to aseptic.

[00:18:55] Speaker 03:
This is aseptically disinfecting.

[00:18:57] Speaker 03:
Disinfecting requires

[00:18:59] Speaker 02:
I'm getting confused for the same reason I was getting confused with your friend.

[00:19:05] Speaker 02:
It seems we all agree that the claim construction of these terms is any FDA regulations related to aseptic processing.

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

[00:19:14] Speaker 02:
Then we just look at what the regulations are.

[00:19:17] Speaker 02:
It's not a claim construction issue, it's what the regulations are.

[00:19:21] Speaker 02:
On its face is 1005 an aseptic

[00:19:25] Speaker 02:
processing regulation.

[00:19:27] Speaker 02:
And it seems to me that there's nothing that limits it to aseptic processing.

[00:19:31] Speaker 02:
It's a limitation on the use of hydrogen peroxide to sterilize food contact surfaces.

[00:19:41] Speaker 02:
Do you mean that you can only use hydrogen peroxide in aseptic processing systems?

[00:19:49] Speaker 03:
Under 1005.

[00:19:50] Speaker 03:
Sterilization.

[00:19:54] Speaker 03:
Sterilization refers to, and it's specifically recited in subpart E of 178.10.05, sterilization refers to commercial sterility under 21 CFR 113.

[00:20:06] Speaker 03:
21 CFR 113 is the aseptic packaging standard for commercial sterility.

[00:20:13] Speaker 04:
174, you're asking us to change our interpretation of the regulation.

[00:20:18] Speaker 04:
Whether you view that

[00:20:20] Speaker 04:
as part of the claim construction or separate from the claim construction, it was still something that was decided in the earlier case and would appear to be binding on us in this case as a matter of collateral estoppel.

[00:20:32] Speaker 03:
No?

[00:20:33] Speaker 03:
I think it's a different patent and it's a different claim term.

[00:20:37] Speaker 04:
On Ohio Willow, we've said that claim construction applies between related patents.

[00:20:43] Speaker 04:
You've agreed it's a related patent?

[00:20:45] Speaker 03:
It is a related patent, but the board here

[00:20:48] Speaker 03:
construed aseptically disinfecting separately from aseptic.

[00:20:53] Speaker 03:
Subsection E of 1781005 specifically refers to 21 CFR 113, which is the aseptic packaging.

[00:21:02] Speaker 02:
Well, but that makes sense because subsection E refers to the use, as your friend explained, of hydrogen peroxide in aseptic systems.

[00:21:11] Speaker 02:
But that doesn't deal with the rest of it, which sets

[00:21:14] Speaker 02:
levels for use of hydrogen peroxide more generally?

[00:21:18] Speaker 03:
This is a use specific regulation.

[00:21:21] Speaker 03:
If you were to try to get approval to use aseptic or hydrogen peroxide for a different use, you would have to get another regulation.

[00:21:30] Speaker 03:
That's the way these work under 21 USC 348.

[00:21:32] Speaker 03:
This preamble says, hydrogen peroxide solution identified in this section may be safely used to sterilize.

[00:21:39] Speaker 03:
Sterilize means aseptic.

[00:21:42] Speaker 03:
Sterilize means commercial sterility, 21 CFR 113.

[00:21:48] Speaker 03:
And the structure of this regulation is that we will define what it is, hydrogen peroxide in A through C, define a limitation.

[00:21:56] Speaker 03:
And what use is this regulation authorizing?

[00:22:00] Speaker 03:
The use of hydrogen peroxide to sterilize packages under 21 CFR 113, which is the aseptic packaging regulation.

[00:22:11] Speaker 03:
This is an aseptic packaging regulation, and I would cite the Chamber's reference, which is at Appendix 2428, that states, quote, the date that Section 178-1005 went into effect, quote, will be remembered as possibly the most important date for aseptic processing in the United States.

[00:22:35] Speaker 03:
On this date,

[00:22:37] Speaker 03:
The FDA approved the restricted use of hydrogen peroxide as a package sterolint.

[00:22:43] Speaker 03:
That is what 178.10.05 does.

[00:22:45] Speaker 03:
178.10.05 provides or authorizes the restricted use of hydrogen peroxide as a sterolint for aseptic packaging.

[00:22:56] Speaker 03:
And with respect, your honor, I believe the panel was misled in the last

[00:23:05] Speaker 03:
in the 1750 appeal to be taken down a path that this is a statute of regulation of general applicability that argument was raised for the first time after the record was closed.

[00:23:15] Speaker 04:
Why is the earlier decision not binding on us?

[00:23:18] Speaker 04:
You don't come to this court and we argue cases.

[00:23:24] Speaker 04:
Why is it not binding as a matter of collateral estoppel?

[00:23:29] Speaker 03:
It's a different claim term, aseptically disinfecting.

[00:23:32] Speaker 03:
So how can it be

[00:23:36] Speaker 03:
consistent, aseptic requires FDA level of aseptic.

[00:23:41] Speaker 03:
Aseptically disinfecting means you have to meet the narrow path of commercial sterility of 113.

[00:23:46] Speaker 04:
Are there any differences between aseptic processing or aseptic disinfecting, right?

[00:23:53] Speaker 04:
I mean, there's no basis for distinguishing between those terms.

[00:23:56] Speaker 04:
It's the context of what is being claimed.

[00:23:58] Speaker 02:
What construction do you think should exist for aseptically disinfecting?

[00:24:05] Speaker 03:
The construction of the board set forth here.

[00:24:06] Speaker 02:
What did the board set forth?

[00:24:08] Speaker 03:
I'm sorry?

[00:24:08] Speaker 02:
What construction did the board set forth?

[00:24:10] Speaker 03:
The board said...

[00:24:22] Speaker 03:
Disinfecting the plurality of bottles in compliance with any applicable FDA regulation.

[00:24:27] Speaker 03:
As mentioned above, when hydrogen peroxide is used to sterilize food packaging material, for example bottles, the FDA limitation on residual hydrogen peroxide is applicable.

[00:24:36] Speaker 02:
That's the same construction that the board used in the 1750 case.

[00:24:41] Speaker 02:
It's the construction we agreed with in part that it means any FDA regulation regarding aseptic processing or aseptic.

[00:24:50] Speaker 02:
It's not a different construction.

[00:24:52] Speaker 02:
You just want us, again, you want us to reconsider what 1005 is for.

[00:24:59] Speaker 03:
There was a statement in the earlier decision that because 178.10.05 is a regulation of general applicability, loose language, it cannot be an FDA regulation.

[00:25:12] Speaker 02:
Right, I get it.

[00:25:13] Speaker 02:
You think we were wrong the first time around.

[00:25:16] Speaker 02:
Maybe we were wrong the first time around.

[00:25:18] Speaker 02:
I think you asked for en banc the first time around.

[00:25:22] Speaker 02:
If you didn't, I'm sorry.

[00:25:23] Speaker 02:
But you certainly didn't get it.

[00:25:24] Speaker 02:
I don't see how we can get out of that on a claim construction, because it's not a different claim construction.

[00:25:31] Speaker 02:
You're asking us to change our regulatory interpretation of what 1005 stands for.

[00:25:38] Speaker 03:
But we did not understand that the 1750 opinion construed 178.10.05 to now make it generally applicable in the food industry.

[00:25:49] Speaker 02:
Well, it certainly said that it was not a regulation directed to aseptic or aseptic processing.

[00:25:58] Speaker 02:
And the claim construction you're relying on in this case from the board, as you read it to me, defines aseptic disinfecting as any FDA regulation relating to aseptic.

[00:26:13] Speaker 02:
And would I?

[00:26:15] Speaker 02:
It's the same argument.

[00:26:18] Speaker 02:
The board apparently finds this regulation to be an aseptic regulation.

[00:26:23] Speaker 02:
The prior panel did not.

[00:26:27] Speaker 03:
The prior Federal Circuit panel did not, yes.

[00:26:35] Speaker 03:
This is the FDA aseptic regulation, 178.10.05, and now there's a statement that is inconsistent, makes the 1750 decision internally inconsistent.

[00:26:48] Speaker 03:
are those FDA regulations governing aseptic packaging?

[00:26:55] Speaker 03:
178.1005 governs aseptic packaging.

[00:26:58] Speaker 03:
Nestle admits it in their brief year.

[00:27:00] Speaker 03:
Subsection E is aseptic packaging, and Subsection E requires the residual requirement.

[00:27:07] Speaker 03:
So they have now conceded, after they got a decision in the 1750 appeal, that in fact 178.1005 is exclusively aseptic.

[00:27:17] Speaker 03:
And you can't reconcile the position from before to now.

[00:27:23] Speaker 03:
And I would just also note with respect to the evidence, there is no evidence to say.

[00:27:28] Speaker 03:
I think we're out of time.

[00:27:29] Speaker 03:
Thank you.

[00:27:30] Speaker 00:
Thank you.

[00:27:44] Speaker 00:
Just a couple of quick points.

[00:27:47] Speaker 00:
The claim term is not different here than it was in the 1750 case.

[00:27:50] Speaker 00:
While the board and the court talked about the word aseptic, it was in the context of aseptically disinfecting.

[00:27:56] Speaker 00:
The word aseptic does not appear in the claims of the 013 patent at all.

[00:28:01] Speaker 00:
The words aseptically disinfecting did.

[00:28:02] Speaker 02:
Can I ask you this?

[00:28:03] Speaker 02:
I think we relied on, although perhaps not extremely heavily, but on the claim differentiation argument in the 1750 case.

[00:28:10] Speaker 02:
Is there the same kind of claim differentiation issues here?

[00:28:15] Speaker 02:
Are there claims in these patents that

[00:28:17] Speaker 02:
in addition to saying aseptically disinfecting then add a dependent claim that puts in the hydrogen peroxide limitation?

[00:28:25] Speaker 00:
Not in this patent, Your Honor.

[00:28:28] Speaker 00:
Our position is that the claim differentiation argument still applies because of the patents are related and the term has to be construed consistent across the patents.

[00:28:38] Speaker 00:
One other quick point that I wanted to make to you is that I think there's a little misunderstanding of what the board did in this appeal.

[00:28:44] Speaker 00:
The board said that aseptic disinfecting means disinfecting the plurality of bottles in compliance with any applicable FDA regulation, not any applicable FDA aseptic regulation.

[00:28:56] Speaker 00:
And it went on to find that the reserves were applied.

[00:29:00] Speaker 00:
My opposing counsel made the statement that Nestle has somehow conceded that 10.05 is an aseptic standard.

[00:29:09] Speaker 00:
We indeed have not.

[00:29:10] Speaker 00:
We do acknowledge the fact that the use of hydrogen peroxide must comply with that standard.

[00:29:15] Speaker 00:
It must be no greater than 35%.

[00:29:16] Speaker 00:
It must meet the residual requirement.

[00:29:22] Speaker 00:
But so must all use of hydrogen peroxide in food processing.

[00:29:29] Speaker 00:
If there's no further questions, I'll see the rest of my time.

[00:29:32] Speaker 04:
OK, thank you.