[00:00:05] Speaker 03:
Our next case is Nestle USA Inc.

[00:00:28] Speaker 01:
vs. Steuben Foods Inc.

[00:00:53] Speaker 01:
This is a motion that was filed this morning, and it's due at the Grand Council.

[00:00:58] Speaker 01:
It doesn't affect our water use.

[00:01:01] Speaker 01:
But I think we have time.

[00:01:01] Speaker 01:
Can I go ahead and... Councillor Jenkins, before we start, let me take care of an administrative matter.

[00:01:14] Speaker 01:
This morning, we had a motion filed, a motion to withdraw Council for Appalachian Student Foods

[00:01:22] Speaker 01:
And we didn't have the time to post our decision, but the motion is granted.

[00:01:31] Speaker 01:
Thank you, Your Honor.

[00:01:33] Speaker 01:
And sir, you have reserved three minutes of your time for rebuttal.

[00:01:36] Speaker 01:
Is that correct?

[00:01:37] Speaker 01:
I have.

[00:01:37] Speaker 01:
OK, you may proceed.

[00:01:38] Speaker 01:
Thank you.

[00:01:40] Speaker 03:
You may please the court.

[00:01:43] Speaker 03:
The board aired in this IPR when it found that Dessley failed to prove unpatentability because board one

[00:01:51] Speaker 03:
misconstrued the claim term aseptic, and two, conducted a flawed obviousness analysis.

[00:01:58] Speaker 03:
Aseptic means the absence of microorganisms.

[00:02:02] Speaker 03:
The board erred by expanding the meaning of aseptic to include the FDA's food additive regulations, which limit the amount of hydrogen peroxide in a packaged food product.

[00:02:14] Speaker 03:
Properly construed claims 18 and 19 do not include a residual hydrogen peroxide limitation.

[00:02:21] Speaker 03:
And because students' arguments and the board's analysis were predicated on this construction, this board should reverse as to those claims.

[00:02:30] Speaker 01:
Well, it does say FDA standard applicable to an FDA standard, correct?

[00:02:38] Speaker 01:
I mean, it does.

[00:02:40] Speaker 01:
Well, your argument, the subject should be the same as the claims of the prior art.

[00:02:48] Speaker 01:
And the claims of SOs refer to, let's see, an FDA standard.

[00:02:59] Speaker 01:
Am I wrong with that?

[00:03:00] Speaker 02:
The claims do not refer to an FDA standard.

[00:03:03] Speaker 02:
But, I mean, the specification clearly says these should be, aseptics should be understood as the FDA standards.

[00:03:13] Speaker 02:
I don't know that we need to quibble about that, because I don't think that that necessarily forecloses your argument, because as far as I can tell, there's nothing in FDA regulations that says this is an aseptic standard.

[00:03:26] Speaker 02:
There's a bunch of different standards that apply to food packaging and processing.

[00:03:31] Speaker 02:
Some of them may relate to whether something's aseptic.

[00:03:34] Speaker 02:
Some of them may be, as you, I think, are trying to say, a food additive standard that doesn't have anything to do with aseptic processing.

[00:03:41] Speaker 02:
But I think we have to start with the notion that the specification did specifically say, use the FDA standard for aseptic.

[00:03:52] Speaker 03:
The specification said, aseptic means the FDA level of aseptic.

[00:04:00] Speaker 03:
Aseptic means the absence of microorganisms.

[00:04:04] Speaker 03:
And our position is that when they say the FDA level of aseptic, they're talking about the FDA standard

[00:04:11] Speaker 03:
for the absence of microorganisms or for using a steroid.

[00:04:16] Speaker 03:
Right.

[00:04:16] Speaker 02:
Can I ask you, are those the same standards that are in claim 18 and 19 about different levels of reduction of swore organisms and a 12-loss reduction in clostridium and phoshalinum?

[00:04:30] Speaker 03:
Well, the UHD process, which is required to sterilize the food,

[00:04:37] Speaker 03:
requires 12 long reduction.

[00:04:39] Speaker 03:
So that's a standard in the industry.

[00:04:43] Speaker 03:
And I think probably... Is that an aseptic standard?

[00:04:46] Speaker 02:
I mean, part of the problem here is we have a patent that says use FDA standards.

[00:04:50] Speaker 02:
Yes.

[00:04:50] Speaker 02:
But I don't see anything any side is pointed to where the FDA said, here are the standards for aseptic.

[00:04:56] Speaker 02:
They just have a bunch of different standards.

[00:04:58] Speaker 02:
That's correct.

[00:04:59] Speaker 02:
And then they're forcing the board and us into trying to put which ones are an aseptic standard and which ones are other standards into a box.

[00:05:06] Speaker 03:
Correct.

[00:05:07] Speaker 03:
And the board's construction was any applicable FDA standard.

[00:05:14] Speaker 03:
So it forces us to go through an analysis of what is applicable, forces us to go through an analysis of what is a standard.

[00:05:21] Speaker 03:
Does that mean it's something that is actually written down as a regulation?

[00:05:26] Speaker 03:
Are there other standards that the FDA uses in the ordinary course of business?

[00:05:33] Speaker 03:
So it becomes a very ambiguous,

[00:05:37] Speaker 03:
clean construction once you go down the route that the board has done, which is to say that FDA level of aseptic includes the 0.5 residual hydrogen peroxide regulation in the FDA regulations.

[00:05:56] Speaker 02:
Well, I get you.

[00:05:58] Speaker 02:
The problem here, and I know it's not for flora, but if it's any FDA standard,

[00:06:05] Speaker 02:
How is the patent even definite?

[00:06:07] Speaker 02:
Because the FDA could change standards that weren't even in existence at the time.

[00:06:15] Speaker 02:
That is correct.

[00:06:16] Speaker 02:
To capture every single change in what the FDA policy assumes is wrong.

[00:06:22] Speaker 03:
And I will tell you that in the district court, this construction, which undoubtedly, if it's firm, the district court is going to rely on, is going to create havoc.

[00:06:31] Speaker 03:
Because it's completely ambiguous as to

[00:06:34] Speaker 03:
what that term means.

[00:06:36] Speaker 02:
Well, I don't know if it'll complete havoc.

[00:06:37] Speaker 02:
I think they might just find it invalid for indefiniteness.

[00:06:42] Speaker 03:
To your point, at one point in time, the hydrogen peroxide residual limitation was 0.1 ppm.

[00:06:52] Speaker 03:
And subsequently, it was changed to 0.5.

[00:06:54] Speaker 03:
So you are correct that once you start talking about FDA regulations or incorporating that into the definition

[00:07:03] Speaker 03:
of aseptic, you're talking about something that changes over time.

[00:07:07] Speaker 02:
If we agree with you that the board is improperly imported this 0.5 hydrogen peroxide limitation into the definition of aseptic, what do we do with the case?

[00:07:19] Speaker 02:
Does it have to be remanded for them to apply the proper construction?

[00:07:23] Speaker 03:
I do not think it needs to be remanded because for a couple of reasons.

[00:07:30] Speaker 03:
All the evidence that was presented by the

[00:07:35] Speaker 03:
pattern relied on the residual standard, the 0.5 residual standard, which was part of its so-called narrow path or the sweet spot that the board presented.

[00:07:47] Speaker 02:
So do you think there's sufficient factual findings by the board for us to find this invalid even under our corrected claim construction?

[00:07:54] Speaker 03:
I think that there's the undisputed disclosures

[00:08:00] Speaker 03:
in the prior art, including Bosch references, are sufficient for this Court to conclude that these claims are obvious as a matter of the law because the claims are so broad.

[00:08:09] Speaker 02:
I guess my problem with that is the Board also said there's a bunch of different Bosch references and couldn't find a motivation to combine.

[00:08:19] Speaker 02:
Now, it was doing it with regard, I think, to the .5 limitation, but it didn't seem to me that we could go out and say that factually there's a motivation to combine these for

[00:08:30] Speaker 02:
these other limitations, even if we set aside the 0.5?

[00:08:33] Speaker 03:
Well, I think that given the undisputed disclosures in the boss references, that the court can certainly make the combination, also given the fact that the claims are so broad.

[00:08:47] Speaker 03:
I mean, the claims have no limit on the size of the machines, the type of container.

[00:08:55] Speaker 03:
You can use a glass container, which can be heated to very high temperatures.

[00:08:59] Speaker 03:
The patent itself acknowledges that aseptic processing was already known.

[00:09:06] Speaker 03:
It acknowledges that in the first column of the patent.

[00:09:13] Speaker 03:
The record shows that there were 500 processes that had been approved by the FDA, aseptic processes, at the time the application was filed.

[00:09:25] Speaker 03:
That's undistributed.

[00:09:26] Speaker 03:
Most of them were not models.

[00:09:29] Speaker 03:
People were doing aseptic processing.

[00:09:32] Speaker 03:
They knew how to kill the bugs.

[00:09:33] Speaker 03:
They knew how to get rid of the hydrogen peroxide.

[00:09:36] Speaker 03:
There's no dispute that the Bosch references disclosed a machine that was actually approved by the FDA, actually sold in the United States.

[00:09:46] Speaker 03:
So there are a lot of undisputed facts in which the court can rely, we believe, to find that these claims are obvious.

[00:09:58] Speaker 02:
Can I ask you, I know this isn't before us, but is, am I correct, is there another proceeding at the board going on now about this patent where the board has invalidated these claims on different references?

[00:10:13] Speaker 02:
Yes.

[00:10:14] Speaker 02:
And so I know that's not final, but that's going to come up presumably to us at some point.

[00:10:20] Speaker 02:
So I guess what we do here is still not going to be final one way or another because we're waiting on

[00:10:28] Speaker 02:
What happens in that case?

[00:10:29] Speaker 03:
Well, if you find that these claims are invalid, then it will be fine.

[00:10:33] Speaker 03:
But there is another case pending.

[00:10:36] Speaker 03:
It's a re-examination that the board has issued a decision on that.

[00:10:44] Speaker 03:
I think there may be a participatory hearing or something still outstanding.

[00:10:49] Speaker 03:
But presumably that will also come up.

[00:10:51] Speaker 02:
I guess I'm just thinking if we agree with you about this incorrect claim construction, isn't the better course for us just to remand it back to the board rather than reach out and make what to me seem uncomfortably like new fact findings, particularly since the board has already invalidated this.

[00:11:09] Speaker 03:
Well, I will point out that claim 20 does, in fact, include a residual hydrogen peroxide limitation.

[00:11:19] Speaker 03:
Sure.

[00:11:20] Speaker 03:
I think that that claim, at a minimum, should be vacated.

[00:11:26] Speaker 03:
That decision should be vacated on that claim because the board really, I think, committed a legally erroneous obviousness analysis, at least in several respects.

[00:11:36] Speaker 03:
As I said earlier, it really ignored the scope of these claims, which are incredibly broad.

[00:11:40] Speaker 03:
It didn't confront the fact that the claims can be covered.

[00:11:45] Speaker 03:
glass bottles, which is one of the type of bottles disclosed in the Bosch references, which allow you to heat the hydrogen peroxide to much higher temperatures.

[00:11:55] Speaker 03:
Makes it more effective as a sterile and makes it easier to get rid of.

[00:11:59] Speaker 03:
Also, the board essentially refused to combine the prior work references, the Bosch prior work references, because they were not identical.

[00:12:13] Speaker 03:
I don't think there's any case or any, certainly that's completely inconsistent with KSR, the idea that somehow there has to be identity between the processes before you can start, you know, using, combining them to look at the parameters.

[00:12:29] Speaker 03:
There's no dispute that these references that come from the same company, they describe essentially the same machine.

[00:12:37] Speaker 03:
Many of the same drawings in the references are identical.

[00:12:41] Speaker 03:
So it would be hard to imagine

[00:12:44] Speaker 03:
a stronger case for combining these references than these Bosch references.

[00:12:50] Speaker 03:
And then the last point I want to make.

[00:12:52] Speaker 01:
Counselor, you're almost out of time, and I want to get to a particular point.

[00:12:55] Speaker 01:
My concern in this case is the construction.

[00:12:59] Speaker 01:
And the board wrote, the question before us is whether the asserted prior art as a whole was enabling such that a skilled artisan would have had a reasonable expectation

[00:13:10] Speaker 01:
of success.

[00:13:11] Speaker 01:
Did anybody argue this mixture of enablement with a reasonable expectation of success?

[00:13:19] Speaker 01:
Do you know where the board got that?

[00:13:22] Speaker 03:
Well, the student argued that the art is unpredictable and one skill in the art would not be able to combine the references with a reasonable expectation of success.

[00:13:34] Speaker 03:
So that was, I think, their position was that there wasn't

[00:13:40] Speaker 03:
sufficient disclosure to enable one skilled New Yorker to practice the invention.

[00:13:45] Speaker 03:
So that was, I think it came from the patent owner's position.

[00:13:53] Speaker 03:
But I think that, I mean the enablement analysis that the board went through I think was incorrect because again it was unwilling to combine the references

[00:14:02] Speaker 03:
And it was unwilling to even compare the disclosure in the patent versus the disclosure that's in the references, suggesting that that was not a relevant comparison, whereas the case law in this court clearly says that you can look at the patent specification to get a sense as to how much disclosure is required in prior... Just to make sure, your argument is that the FDA level of subject

[00:14:29] Speaker 01:
Because the specification, I think I said claims earlier that the claims had that.

[00:14:34] Speaker 01:
But it's in specification.

[00:14:35] Speaker 01:
The FDA level of septic does not include the 0.5 FDA standard.

[00:14:43] Speaker 03:
Correct.

[00:14:43] Speaker 03:
Because it's not a septic standard.

[00:14:45] Speaker 03:
It's a standard that applies to any process that might use hydrogen peroxide.

[00:14:50] Speaker 03:
It's a food additive limitation in the claim.

[00:14:55] Speaker 03:
So if you were going to use hydrogen peroxide in a process that was not

[00:14:59] Speaker 03:
aseptic, which are processes which are basically shelf stable, you don't have to refrigerate them.

[00:15:08] Speaker 03:
But if you did it for another process that wasn't aseptic, not quite as much sterilization, you would still have to meet the zero point.

[00:15:16] Speaker 01:
Alright, let's hear from the other side now.

[00:15:36] Speaker 00:
The burden in this IPR was on Nestle to prove unpatentability of the challenge claims by proponents of the evidence.

[00:15:52] Speaker 00:
The burden never shifted to Steuben, and for that matter to the Board, but remained on Nestle throughout the proceeding.

[00:15:58] Speaker 00:
This Court made that clear in the Magnum Oil decision last year.

[00:16:02] Speaker 00:
To carry its burden, Nestle was required to demonstrate

[00:16:06] Speaker 00:
both that a skilled artisan would have had reason to combine the preferences, and that in doing so, that a skilled artisan would have had a reasonable expectation of success.

[00:16:16] Speaker 00:
That's what he failed to do either.

[00:16:19] Speaker 01:
Let's take a look at the board's construction of a septic.

[00:16:24] Speaker 01:
The board said, a septic to any applicable U.S.

[00:16:29] Speaker 01:
FDA standard, and in the absence of any such standard, a septic assumes its ordinary meaning of free.

[00:16:35] Speaker 01:
So there's two words here that concern me, and that's applicable.

[00:16:38] Speaker 01:
I mean, if we don't know which one, I mean, it's pretty wide open to any applicable.

[00:16:46] Speaker 01:
So it's something that's determined in the future.

[00:16:49] Speaker 01:
Then it goes on that says, and in the absence, these appear to me to be two contingencies that create a flawed construction.

[00:17:02] Speaker 00:
This is a lexicography case, first and foremost.

[00:17:05] Speaker 00:
The patent specification expressly defines aseptic twice, as meaning the U.S.

[00:17:12] Speaker 00:
FDA level of aseptic.

[00:17:14] Speaker 00:
Those skilled in the art well understood what the U.S.

[00:17:17] Speaker 00:
FDA level of aseptic was.

[00:17:19] Speaker 00:
It's explained in the specification.

[00:17:21] Speaker 00:
It's explained in the prior art.

[00:17:23] Speaker 00:
There is a requirement for commercial stability.

[00:17:27] Speaker 00:
on the packages and in the food.

[00:17:29] Speaker 00:
Jenkins talked about the UHD food.

[00:17:31] Speaker 00:
That's commercial sterility on the food.

[00:17:33] Speaker 00:
This is in 21 CFR 113.

[00:17:36] Speaker 00:
So there's a requirement for commercial sterility.

[00:17:39] Speaker 00:
There's also that same commercial sterility requirement applies to the packages.

[00:17:43] Speaker 00:
So those skilled in New York understood that if you're going to do an aseptic process, you have to achieve commercial sterility of the food that you're gonna put into it and the package that you're gonna put it into.

[00:17:53] Speaker 00:
There's another aseptic standard

[00:17:57] Speaker 00:
that says that you can achieve commercial sterility using chemical steriles.

[00:18:04] Speaker 00:
Hydrogen peroxide is a chemical sterile.

[00:18:06] Speaker 00:
There's another FDA standard that says if you're going to put hydrogen peroxide on a package, you must remove the hydrogen peroxide such that there's no more than 0.5 ppm residual on that package.

[00:18:19] Speaker 00:
Those skilled in the art well understood this.

[00:18:22] Speaker 00:
This was the difficult nut to crack in the United States.

[00:18:26] Speaker 00:
Aseptic was being done in Europe.

[00:18:29] Speaker 00:
They did not have the 0.5 BPM requirement.

[00:18:32] Speaker 00:
We put in our brief several examples of failures of companies that were already in the aseptic business in Europe.

[00:18:41] Speaker 00:
We tried to bring that technology to the United States and they failed.

[00:18:45] Speaker 00:
In one case, the Gallup case, five year effort.

[00:18:53] Speaker 02:
You can't point to anything where the FDA says this 0.5 standard is an aseptic standard.

[00:19:01] Speaker 02:
I'm not sure the record demonstrates this, but I imagine hydrogen peroxide can be used in other forms of food processing that's not aseptic processing.

[00:19:11] Speaker 02:
This standard, I take it, still applies.

[00:19:14] Speaker 02:
You can't have more than 0.5 hydrogen peroxide in any kind of food.

[00:19:20] Speaker 02:
whether you use it as like a vegetable wash or an aseptic.

[00:19:23] Speaker 02:
So why is that an aseptic standard versus some other kind of standard?

[00:19:27] Speaker 00:
Because for those skilled in the art, again, we have to construe the claims through the lens of one skilled in the art.

[00:19:34] Speaker 00:
Those skilled in the art understood that to achieve aseptic in terms of the package, you're going to have to use a chemical serum.

[00:19:42] Speaker 00:
Certain chemical serums can be used.

[00:19:44] Speaker 00:
If you're going to use a serum that includes hydrogen peroxide,

[00:19:47] Speaker 00:
that invokes the 0.5 PPM residual requirement.

[00:19:51] Speaker 00:
That's an FDA requirement.

[00:19:53] Speaker 02:
That was... But why is it an aseptic requirement as opposed to a related requirement?

[00:19:59] Speaker 02:
It may be, I can't imagine that there's not, that when you use glass bottles with plastic caps that there's probably all kinds of different standards that say what kind of glass you can use, what kind of plastic you can use.

[00:20:11] Speaker 02:
Are those aseptic standards too?

[00:20:14] Speaker 00:
I'm not familiar with those regulations.

[00:20:16] Speaker 00:
But no, it's the context of aseptic.

[00:20:19] Speaker 00:
And again, the FDA's regulations provide a framework.

[00:20:25] Speaker 00:
If you're going to do aseptic packaging, you have to achieve commercial sterility on the package.

[00:20:32] Speaker 00:
You have to achieve commercial sterility on the food.

[00:20:36] Speaker 00:
You have to use a chemical sterilant to get commercial sterility.

[00:20:40] Speaker 00:
If you're going to use a commercial sterile that includes hydrogen peroxide, you have to achieve the 0.5 ppm.

[00:20:47] Speaker 00:
This is throughout all of the aseptic packaging.

[00:20:50] Speaker 00:
What if that regulation changes in the future?

[00:20:52] Speaker 00:
I'm sorry?

[00:20:53] Speaker 00:
What if that changes and becomes a 0.2 or a 0.7?

[00:20:57] Speaker 00:
I think the question then becomes, was it a foreseeable change?

[00:21:02] Speaker 00:
It's a standard.

[00:21:04] Speaker 00:
Let me ask you this another way.

[00:21:07] Speaker 02:
Why would we read the 0.5 limitation into all these claims when you have specifically put the 0.5 limitation in claim 20?

[00:21:17] Speaker 02:
I mean, isn't that contrary to our normal principles of claim differentiation?

[00:21:23] Speaker 00:
Let me take the first part first.

[00:21:25] Speaker 00:
I don't think that 0.5 PPM is part of the claim construction.

[00:21:28] Speaker 00:
I think that the claim construction is lexicography.

[00:21:33] Speaker 00:
In this patent,

[00:21:35] Speaker 02:
I don't understand that at all.

[00:21:36] Speaker 02:
You're saying that the definition of aseptic does not include a 0.5 reduction.

[00:21:41] Speaker 02:
Not necessarily.

[00:21:42] Speaker 02:
The lexicographic... Well, that's the construction the board used.

[00:21:47] Speaker 00:
The board found that if we're under the lexicography, USFDL of aseptic, so that's the definition of aseptic.

[00:21:55] Speaker 00:
There is a claim term that requires aseptically disinfecting.

[00:22:00] Speaker 00:
What does that mean?

[00:22:02] Speaker 00:
That means that you need to meet the applicable FDA standards to aseptically disinfect that bottle, package.

[00:22:09] Speaker 00:
That means you have to get enough Sterilin on it to achieve commercial sterility.

[00:22:13] Speaker 00:
And if you're using Hydroproxide, you gotta get it off to meet .5 BPM.

[00:22:18] Speaker 00:
That's the applicable FDA standard for aseptically disinfecting.

[00:22:22] Speaker 00:
So it was an application of the claim construction FDA standards to this

[00:22:29] Speaker 00:
Determine the scope of the prior arc to determine if that limitation had been met.

[00:22:34] Speaker 02:
That just baffles me what you just said.

[00:22:36] Speaker 02:
Does the claim construction of aseptic include the 0.5 or not?

[00:22:41] Speaker 00:
The construction, based on our psychography, is FDA level of aseptic.

[00:22:50] Speaker 02:
Which either includes the 0.5 or it doesn't.

[00:22:52] Speaker 02:
That's right.

[00:22:54] Speaker 02:
And the prior arc does not.

[00:22:56] Speaker 02:
The board found it does.

[00:22:58] Speaker 02:
The board looked at the challenge.

[00:23:01] Speaker 02:
The challenge was all... Because they found that there was no reasonable expectation that a person with ordinary skill would confine this prior art to achieve .5.

[00:23:08] Speaker 02:
No.

[00:23:11] Speaker 02:
With respect to the .5, the board found that... Look, I mean, you're not going to get out of here with an answer to whether the claim construction includes a .5 or not.

[00:23:21] Speaker 02:
How could we ever assess whether the board was proper in

[00:23:25] Speaker 02:
in applying a claim construction when we don't even know what you think the claim construction was.

[00:23:29] Speaker 00:
I think the claim construction was the lexicography that the applicable FDA standards apply.

[00:23:34] Speaker 00:
Which is a point five.

[00:23:36] Speaker 00:
Hydrogen peroxide.

[00:23:38] Speaker 00:
The point I want to say out is that first you construe the claims and then you determine if the claims are met by the challenge.

[00:23:46] Speaker 00:
The board looked at the challenge.

[00:23:48] Speaker 00:
All of the references asserted in the challenge were low acid, aseptic,

[00:23:53] Speaker 00:
packaging using a hydrogen peroxide sterolite.

[00:23:57] Speaker 00:
So the board took the claim construction FTA standards and said for that challenge, those hydrogen peroxide sterolite references, for those references to teach this claim, those references have to meet .5.

[00:24:14] Speaker 00:
Otherwise they're not meeting the FTA standard.

[00:24:17] Speaker 00:
So it was a finding of fact and determining whether that challenge met

[00:24:22] Speaker 00:
the lexicographic definition of FDA standard?

[00:24:26] Speaker 01:
I'm not sure about the arguments that we have a lexicographer situation here.

[00:24:33] Speaker 01:
We may, but it seems to me that if there was an attempt to define a septic to include FDA level, and if the attempt was to identify a specific level, then the attempt failed.

[00:24:53] Speaker 01:
There's nothing clear or reasonable or anything that lends clarity by the definition of FDA level of a septic.

[00:25:04] Speaker 01:
I mean, that doesn't mean much.

[00:25:08] Speaker 01:
Other than perhaps some standard, some FDA standard, at least one, one FDA standard has to be met.

[00:25:15] Speaker 00:
They all have to be met.

[00:25:17] Speaker 00:
And to be clear, it's a framework.

[00:25:19] Speaker 00:
It's commercial stability.

[00:25:21] Speaker 00:
killing the bad stuff on the bottles.

[00:25:24] Speaker 00:
And it's the residual standard if you're using hydrogen peroxide.

[00:25:27] Speaker 00:
So you've got to thread that needle.

[00:25:29] Speaker 00:
Those skilled in the art, the record is unique, or is unanimous.

[00:25:39] Speaker 00:
Did those skilled in the art understand that the FDA requires commercial sterility?

[00:25:43] Speaker 00:
The record is unanimous.

[00:25:44] Speaker 00:
All the evidence shows that those skilled in the art, all including medicine expert Dr. Heldman,

[00:25:50] Speaker 00:
Understand that the 0.5 PPM residual requirement is an FDA standard.

[00:25:54] Speaker 00:
With that backdrop, and Dr., or Mr. Taggart, defining his invention, hey, this stuff's been done, but nobody can thread the needle with the 0.5 PPM and the commercial sterility.

[00:26:05] Speaker 00:
Here's how you do it, and it's highly complex.

[00:26:08] Speaker 00:
You've got to get enough Sterilin on.

[00:26:10] Speaker 00:
You've got to get it on in a way that you don't have big droplets.

[00:26:12] Speaker 00:
If you have big droplets, you're not going to have to be able to get it off

[00:26:15] Speaker 00:
You have to have the right dwell times.

[00:26:17] Speaker 00:
You have to have the right air flows.

[00:26:18] Speaker 00:
You have to do it all in a sterile tunnel.

[00:26:20] Speaker 00:
You have to remove it, and you have to remove it sufficiently.

[00:26:23] Speaker 02:
And almost everything you just said is not in the claims.

[00:26:28] Speaker 00:
This is the FDA standard that has to be met.

[00:26:31] Speaker 00:
It's a complex invention.

[00:26:33] Speaker 00:
Mr. Tigert was the first to achieve a high-speed, low-acid, aseptic.

[00:26:38] Speaker 00:
But he didn't claim any of those things you just said.

[00:26:40] Speaker 00:
He claimed it through the aseptically disinfecting to meet the FDA standards.

[00:26:45] Speaker 00:
It was those FDA standards that was driving everything.

[00:26:49] Speaker 02:
But you just listed about half a dozen different things that have to be performed to meet this standard, but didn't put a single one of those in the claims.

[00:26:58] Speaker 02:
So how are those elements of the claims?

[00:27:01] Speaker 02:
It sounds to me like no invention whatsoever to just say, there's this FDA standard out here.

[00:27:05] Speaker 02:
Let's do it in a high-speed way, and let's meet it.

[00:27:11] Speaker 02:
He shows how to do it.

[00:27:12] Speaker 00:
Prior Art couldn't do it.

[00:27:14] Speaker 00:
He didn't put it in his claims.

[00:27:15] Speaker 00:
I mean, you're not just getting that in.

[00:27:17] Speaker 00:
He put it in his claims through lexicography.

[00:27:19] Speaker 00:
We're going to meet the FDA level of a subject.

[00:27:23] Speaker 01:
So claim 20 incorporates the specific FDA regulation, the 0.5 residual peroxide that we're talking about.

[00:27:30] Speaker 01:
If you read that standard into that claim, then the claim is rendered superfluous.

[00:27:37] Speaker 00:
No, because the claim 18 would not require hydrogen peroxide.

[00:27:40] Speaker 01:
I'm not claiming 18.

[00:27:41] Speaker 01:
I'm talking about claim 20.

[00:27:44] Speaker 01:
If you read the 0.5 limitation into that claim, which already has that limitation in it.

[00:27:54] Speaker 00:
Again, I don't think it's proper to expressly read 0.5 in because the lexicography is FDA standards.

[00:28:03] Speaker 00:
But you say any, that they're all applicable.

[00:28:07] Speaker 00:
The FDA standards are applicable.

[00:28:08] Speaker 00:
Including the 0.5?

[00:28:10] Speaker 00:
Yes.

[00:28:11] Speaker 00:
in the context where it's... Well, that's my question.

[00:28:13] Speaker 01:
If you read that standard into Claim 20, then it renders that claim superfluous.

[00:28:18] Speaker 01:
That's contrary to construction rules, isn't it?

[00:28:22] Speaker 00:
I don't think that that's... I think it's a common way to narrow the claim.

[00:28:26] Speaker 00:
You claim broadly, and the concept basically disaffecting includes 0.5 in some instances, and you can claim that as a fact that you've... Why would you read a 0.5 level into a claim that already states that?

[00:28:40] Speaker 00:
The claim states, reading it based just on the lexicography, this claim would state that it was to the FDA level of aseptic using hydrogen peroxide and 0.5 ppm, whereas claim 18 would say to the FDA level of aseptic would not be limited to hydrogen peroxide and 0.5 ppm.

[00:28:57] Speaker 00:
So it's a different way of claiming, and I think that differentiation is a rule of thumb.

[00:29:01] Speaker 00:
It's not a hard and fast rule.

[00:29:03] Speaker 00:
I think that that's consistent.

[00:29:10] Speaker 00:
I'd like to mention, my time's running short here, with respect to the other proceedings, there are now five PFAT panels who have agreed that the proper construction of ASEPTIC, the Dribble-Lide Lexicography, and the EFT level of ASEPTIC, all of the final decisions in five different PFAT panels.

[00:29:32] Speaker 00:
In Nestle's brief, they refer to the claim construction and re-exam proceeding,

[00:29:39] Speaker 00:
prior to nesting the five-week vet re-exam panel, withdrew that decision, and expressly adopted the claim instructions set forth in this proceeding.

[00:29:47] Speaker 00:
So they've all now adopted the lexicographic definition that aseptic means FDA-level aseptic.

[00:29:54] Speaker 00:
With respect to Your Honor's questions on enablement, that's not before this Court.

[00:30:02] Speaker 01:
Again, I think that it's not before the Court, but the Board does use that term.

[00:30:09] Speaker 01:
And I thought that was rather odd, that this statement that the board read was confused.

[00:30:17] Speaker 01:
It's mixed up, and it's odd.

[00:30:20] Speaker 00:
And that did not come from Paten, or I think that came from Petitioner, where they argued that the references, the boss references, were enabled more so than the elementary patent.

[00:30:34] Speaker 00:
That's contradicted by the evidence, Dr. Buhman.

[00:30:37] Speaker 00:
great detail on the 013 and explained that the one scale in the art could get the solution from the 013 patent, could not even begin the process from the boss structures.

[00:30:49] Speaker 00:
I think the board was using enable to colloquially and not looking at an enablement argument.

[00:30:58] Speaker 00:
It specifically rejected Nestle's argument that enablement matters.

[00:31:03] Speaker 00:
It said specifically,

[00:31:05] Speaker 00:
and expressly that there is no 102 issues here.

[00:31:08] Speaker 00:
The name of that is 102, not 102.

[00:31:11] Speaker 01:
All right.

[00:31:11] Speaker 00:
Thank you.

[00:31:24] Speaker 01:
You have two minutes of your time.

[00:31:25] Speaker 03:
Thank you.

[00:31:27] Speaker 03:
I'd like to go back to the question about if the court decides that the claim construction

[00:31:35] Speaker 03:
that the board adopted was an error.

[00:31:39] Speaker 03:
Should the case be remanded or should the court go ahead and decide the obviousness issue here?

[00:31:46] Speaker 03:
And I think that the case is right for a decision of obviousness here.

[00:31:54] Speaker 03:
They're not unlike the summary judgment decision that the Supreme Court basically made in the KSR case based on the

[00:32:05] Speaker 03:
teachings and the references.

[00:32:09] Speaker 02:
I'm just confused as to how we can do that with claim 20, which does include this limitation.

[00:32:13] Speaker 02:
I mean, even if we agree with you that aseptic, the definition of aseptic itself doesn't include the 0.5 hydrogen peroxide.

[00:32:22] Speaker 02:
Claim 20 specifically does it, and that's the finding that the board made that these references put together, you wouldn't combine them to come up with all these elements.

[00:32:33] Speaker 02:
I know you want us to look at it again and say, well, of course you would combine that.

[00:32:36] Speaker 02:
And maybe I agree with you as a matter of fact, but I can't do that.

[00:32:40] Speaker 02:
I mean, that's a factual finding that we can't reverse unless there's a complete lack of substantial evidence.

[00:32:47] Speaker 02:
So it seems like the claim 20 at the very least has to go back.

[00:32:53] Speaker 03:
Well, I would say that the petition established a prima facie case of obviousness.

[00:33:01] Speaker 03:
That was confirmed by the institution.

[00:33:05] Speaker 02:
I get what you're saying.

[00:33:06] Speaker 02:
It seems to me that the board messed this up.

[00:33:10] Speaker 02:
But it's a question of what our standard of review here is.

[00:33:14] Speaker 02:
And the board made a finding that you would not combine these different Bosch references to come up with all these elements, including the 0.5 limitation.

[00:33:22] Speaker 02:
And I don't find that so unreasonable that it lacks in substantial evidence.

[00:33:26] Speaker 02:
I don't get to do it.

[00:33:28] Speaker 02:
on appeal for the first time.

[00:33:31] Speaker 02:
So at least with regard to claim 20, I don't know how we get around that lack of combination finding.

[00:33:38] Speaker 03:
Well, because at a minimum, it needs to be remanded because of the legal errors that were made in this obviousness analysis.

[00:33:45] Speaker 03:
OK.

[00:33:46] Speaker 03:
That's all.

[00:33:46] Speaker 03:
Thank you.

[00:33:47] Speaker 01:
All right.

[00:33:47] Speaker 01:
Thank you.