[00:00:00] Speaker 03:
And our next case is number 171290, Steuben Foods Inc.

[00:00:05] Speaker 03:
versus Nestle USA, Mr. Fisher.

[00:00:25] Speaker 04:
The board erred in several respects in this IPR, both substantively and procedurally.

[00:00:30] Speaker 04:
Substantively, the board erred in construing sterile concentration level so broadly that it reads the invention out of the claims.

[00:00:39] Speaker 04:
Under the proper construction, the final written decision should be reversed because there is no evidence in the record that the asserted prior art taught maintaining the airborne sterile concentration levels of the various zones of the sterilization tunnel.

[00:00:52] Speaker 04:
even under the board's overly broad construction.

[00:00:55] Speaker 03:
So what you're doing is you're saying that the board's claim construction is wrong insofar as they said that an on the bottle measurement would be within the claim line, right?

[00:01:09] Speaker 04:
That's correct.

[00:01:10] Speaker 03:
And if I understand correctly that the board found that the claim construction didn't make any difference with respect

[00:01:19] Speaker 03:
to the claims perhaps other than claim three.

[00:01:22] Speaker 03:
Is that correct?

[00:01:24] Speaker 04:
That's what the board said, but there is no substantial evidence to support such a finding because the references do not discuss airborne sterile concentration levels whatsoever, let alone maintaining a ratio of the airborne sterile concentration levels among the zones.

[00:01:41] Speaker 03:
Well, so you'd have to say that the board's conclusion that under your claim construction,

[00:01:48] Speaker 03:
claim was still obvious was not supported by substantial evidence then, right?

[00:01:53] Speaker 03:
That's correct.

[00:01:55] Speaker 03:
Why isn't it?

[00:01:56] Speaker 04:
Because the references are silent as to airborne sterile concentration levels.

[00:02:02] Speaker 04:
So there's no prima facie case of obviousness of having or establishing.

[00:02:08] Speaker 03:
Didn't they say that Shoal disclosed 300,000 parts per million, right?

[00:02:16] Speaker 03:
That's a different number.

[00:02:17] Speaker 03:
That's not airborne.

[00:02:19] Speaker 03:
That's not airborne?

[00:02:20] Speaker 03:
No.

[00:02:20] Speaker 03:
They found it was, didn't they?

[00:02:22] Speaker 04:
No, they found that that number comes from the 30% hydrogen peroxide in the tank, 30% being 300,000 parts.

[00:02:28] Speaker 03:
Well, they said when it was vaporized it would be 300,000 parts.

[00:02:32] Speaker 04:
Right?

[00:02:34] Speaker 04:
I don't believe the board said that.

[00:02:37] Speaker 04:
They said that there was a, they did not say there was airborne sterile.

[00:02:41] Speaker 04:
They said that there was a disclosure in Sholey with respect to

[00:02:49] Speaker 04:
Airflows and that was our position on that was that those air flows were to prevent contaminants from entering they were not the inventive airflow regime here, which would control the migration of the airborne sterilant So prior

[00:03:15] Speaker 02:
decision does that have any any relevance here and if so what is it?

[00:03:21] Speaker 04:
Only that the the challenge the result effective parameter challenge the only way that the petitioner was able to get there was to rely on what was found in all the references which was that there was evidence of the residual requirement.

[00:03:38] Speaker 02:
So in this case does a prior ruling help you or hurt you?

[00:03:43] Speaker 04:
It's just

[00:03:44] Speaker 04:
Neither.

[00:03:46] Speaker 04:
There are different claim terms aseptically disinfecting.

[00:03:49] Speaker 04:
Aseptic is not a claim term here.

[00:03:53] Speaker 04:
It's just further evidence that all the references dealing with aseptic processing suggest and address the 178.1005 residual requirement.

[00:04:05] Speaker 04:
The board did not address airborne sterile concentrations levels in the final written decision.

[00:04:13] Speaker 02:
Okay, in this case you're saying that Shoal does not disclose any type of airborne mix or that this is used, that the serialization is used in an airborne manner.

[00:04:27] Speaker 04:
Airborne?

[00:04:29] Speaker 04:
Yes, there's no disclosure of that.

[00:04:34] Speaker 04:
But the board found that there was, right?

[00:04:38] Speaker 04:
The board did not address airborne sterile in the final written decision.

[00:04:41] Speaker 02:
But what Shull says, a sterilizing agent is continuously sprayed as a mist into the spraying compartment.

[00:04:49] Speaker 02:
Then goes on and talks about sterilizing H2O2 warm air mixture flows around.

[00:04:56] Speaker 02:
That's not airborne?

[00:04:58] Speaker 04:
Oh, there's certainly airborne sterilant.

[00:04:59] Speaker 04:
But what the claims require is establishing zones that have different concentrations of airborne sterilant and maintaining a ratio

[00:05:08] Speaker 04:
of those airborne sterile concentrations as among the zones, at a number of 5 to 1 in most claims and 0.1 to 1,000 ppm in other zones.

[00:05:19] Speaker 04:
And none of the references discuss that concept.

[00:05:22] Speaker 03:
Okay, but suppose we were to agree with the board's claim construction that it would encompass both airborne concentrations and concentrations on the bottom, on the container.

[00:05:35] Speaker 03:
Do you lose them?

[00:05:37] Speaker 04:
We do not lose because the board committed a number of procedural errors.

[00:05:43] Speaker 04:
On this point, we would not lose because there's no substantial evidence to find, there are no findings in the final written decision with respect to maintaining those numbers.

[00:05:55] Speaker 03:
But that's a different point.

[00:05:57] Speaker 03:
I'm just saying in terms of the ratios.

[00:06:00] Speaker 03:
If the board was correct that you would include measurement on the container, you'd lose on that point, right?

[00:06:06] Speaker 04:
As to the claims with the five to one, maybe.

[00:06:14] Speaker 04:
Conceptually, it makes no sense to me what the board found.

[00:06:17] Speaker 03:
If you find that it's... But try to go with me, because I'm asking a hypothetical.

[00:06:22] Speaker 03:
If we lose the claim... If we agree with the board's claim instruction in this respect, then the board was

[00:06:29] Speaker 03:
There's no basis for saying the board was incorrect in finding that on the bottle measurements were satisfied.

[00:06:39] Speaker 04:
Correct.

[00:06:40] Speaker 03:
Claims require much more.

[00:06:42] Speaker 04:
They require maintenance.

[00:06:43] Speaker 04:
I understand the maintenance.

[00:06:45] Speaker 04:
They require ratio and maintenance.

[00:06:47] Speaker 03:
Yes.

[00:06:51] Speaker 03:
So why isn't the board's claim construction right?

[00:06:56] Speaker 03:
Because the FDA regulations, which seem to be the focus of this patent as well as the others, are talking about the levels of sterilant on the bottle and not in the air, right?

[00:07:07] Speaker 04:
In the other patents and the other claim terms in aseptically disinfecting, what this is, and yes, it's still within the FDA regulations, 21 CFR 113 also requires that the sterilization of the packaging, which implies applying the sterilant and getting it off,

[00:07:25] Speaker 04:
and the filling of that sterile package with sterile food be done in a sterile environment.

[00:07:31] Speaker 04:
These claims are directed to how to set up that sterile environment and maintain a machine that can achieve the sterilization by getting the high kill level using enough sterilant in there and fill the aseptically processed product into the sterile bottle in a way that won't violate the

[00:07:52] Speaker 04:
the FDA's regulations for both the kill and the residual.

[00:07:55] Speaker 04:
And this is the regime for managing that what's called a sterile tunnel.

[00:08:00] Speaker 04:
We're going to have high levels of sterile concentration where you're doing the sterilization.

[00:08:05] Speaker 04:
We need to have a low level of sterilization, airborne sterile where we're doing the filling.

[00:08:10] Speaker 03:
Does the FDA regulations have an airborne standard?

[00:08:14] Speaker 04:
No.

[00:08:15] Speaker 04:
No, this is set forth in that.

[00:08:17] Speaker 03:
Well, my question is, in the light of that fact, why isn't it reasonable for the board to construe this as addressed to the on-the-bottle measurements?

[00:08:27] Speaker 04:
It's a different concept.

[00:08:29] Speaker 04:
Certainly, any bottle that goes through that machine is going to have to meet the FDA's 178-1005 residual requirement.

[00:08:36] Speaker 04:
You have to prove that the machine can do that.

[00:08:38] Speaker 04:
But what these claims are directed to is establishing an airflow regime

[00:08:42] Speaker 04:
and a sterile concentration, airborne sterile concentration regime that can facilitate that process and still meet the FDA's requirements.

[00:08:51] Speaker 04:
Bottles will still have to be tested for the residual, satisfying the residual, as will the bottles have to be tested that they get the sufficient kill.

[00:09:01] Speaker 04:
These claims are directed to maintaining airborne sterile concentration among the zones in such a system.

[00:09:09] Speaker 02:
Among what?

[00:09:11] Speaker 02:
What did you just say?

[00:09:12] Speaker 04:
These claims are directed to maintaining airborne sterilant concentration levels among the various zones of the aseptic system.

[00:09:22] Speaker 04:
There's a filling zone and a sterilizing zone and capping zone.

[00:09:26] Speaker 02:
And your argument is that the prior art doesn't disclose this airborne sterilization in all the zones or in certain zones?

[00:09:34] Speaker 04:
The prior art does not disclose airborne sterilant concentration levels whatsoever, nor does it disclose maintaining them

[00:09:43] Speaker 04:
at relative levels in the system.

[00:09:46] Speaker 04:
The prior art is silent on that.

[00:09:49] Speaker 02:
As to the levels or as to just the use of the airborne sterilant?

[00:09:56] Speaker 04:
Airborne sterilant is known to spray sterilant.

[00:10:01] Speaker 04:
It's the atmosphere, the airborne sterilant of the zone itself that the prior art is silent on.

[00:10:09] Speaker 04:
If you've got a machine that's got a sterilization zone,

[00:10:12] Speaker 04:
which the airborne sterile concentration in that zone as compared to the airborne.

[00:10:16] Speaker 02:
I understand that.

[00:10:17] Speaker 02:
I just read to you from different portions of the show reference.

[00:10:21] Speaker 02:
It seems to me to meet that limitation.

[00:10:24] Speaker 04:
They don't discuss any ratio of from zone to zone.

[00:10:29] Speaker 02:
This is what I was asking.

[00:10:32] Speaker 02:
What's the relevance of the ratio with respect to whether there's an airborne sterile that's used or not?

[00:10:38] Speaker 04:
Airborne sarin is used, and Sholey does discuss that.

[00:10:41] Speaker 04:
Yes, it's the... And that's what I was asking.

[00:10:43] Speaker 04:
Yes, I'm sorry.

[00:10:44] Speaker 04:
I apologize if I missed that point.

[00:10:46] Speaker 04:
What the prior art does not show is that it's going to be at this level relative to this level in these two different zones based on what's happening in those zones in the mission.

[00:10:55] Speaker 03:
But Sholey discloses 300,000 parts per million, right?

[00:11:00] Speaker 04:
I'm sorry?

[00:11:01] Speaker 03:
Sholey.

[00:11:02] Speaker 03:
Sholey discloses 300,000 parts per million.

[00:11:04] Speaker 04:
surely discloses using 30 percent hydrogen peroxide.

[00:11:09] Speaker 03:
Which the board found translated to 300,000 parts per million, right?

[00:11:14] Speaker 03:
At least at the inception.

[00:11:15] Speaker 03:
In the tank.

[00:11:16] Speaker 03:
Yeah.

[00:11:17] Speaker 04:
But once it's airborne, it's not going to be 300,000.

[00:11:18] Speaker 04:
Well, they found that it would be, right?

[00:11:21] Speaker 04:
No, I think that they said, I think what the board's findings are is that you can look at the drop, a drop of sterilant at any point in the zone and

[00:11:32] Speaker 03:
What I'm asking you is what they found about shock.

[00:11:38] Speaker 03:
Didn't they say that it discloses?

[00:11:41] Speaker 04:
They did not address airborne sterile concentration levels in the final written decision.

[00:11:46] Speaker 03:
This is on page 23.

[00:11:47] Speaker 03:
Find a concentration of 30% solution of hydrogen peroxide will remain close to 300,000 parts per million in the liquid phase at some point after it's sprayed into the spraying compartment.

[00:12:02] Speaker 04:
After condensation, that would be in the liquid form, not in the airborne.

[00:12:09] Speaker 03:
And it talks about your expertise.

[00:12:11] Speaker 03:
You acknowledge that after condensation, the concentration of hydrogen peroxide that coats the containers is somewhere in the neighborhood of 30% or 300,000 parts per million, right?

[00:12:23] Speaker 04:
This is saying nothing more, Your Honor, and this really demonstrates why we think this claim construction is wrong.

[00:12:30] Speaker 04:
We're saying nothing more than if you have 30% hydrogen peroxide in the tank and you use it in a system and it condenses back down and you look at the drop of sterolint wherever you are, it's going to be that 30% hydrogen peroxide again.

[00:12:42] Speaker 04:
But that's not what these claims and that's not what this invention is about.

[00:12:45] Speaker 04:
Well, that comes back to the claim construction.

[00:12:47] Speaker 04:
Yes.

[00:12:47] Speaker 04:
If it's airborne sterolint, it's not going to be 30.

[00:12:50] Speaker 04:
That 30% hydrogen peroxide dispersed in the air is not going to be 30% airborne sterolint.

[00:12:58] Speaker 02:
The board disagreed with that argument.

[00:13:00] Speaker 04:
The board disagreed that you have to look at the steroid, airborne steroid.

[00:13:04] Speaker 04:
They said that you can look at a drop.

[00:13:06] Speaker 03:
So once the drop condenses... I don't think they talked about a drop.

[00:13:09] Speaker 03:
They talked about concentration on the bottle.

[00:13:13] Speaker 03:
Condensed.

[00:13:14] Speaker 03:
Yeah.

[00:13:16] Speaker 04:
And the 30% is condensed in the .5.

[00:13:19] Speaker 04:
Conceptually now the .5 is how many of those drops can remain in the bottle before you fill it.

[00:13:26] Speaker 04:
And it has to be less than 0.5 ppm.

[00:13:29] Speaker 04:
That's an entirely different concept from maintaining, establishing zones with partitions, establishing air flows throughout the zone, having different pressure levels so that the migration of sterolint goes in different directions.

[00:13:44] Speaker 04:
That's what these inventions claim.

[00:13:47] Speaker 04:
And the claims set forth sterolint concentration levels of the zones or in the zones, not in the liquid itself.

[00:13:56] Speaker 03:
You want to save the rest of your rebuttal time there?

[00:14:15] Speaker 01:
Good morning, Your Honor.

[00:14:18] Speaker 01:
As it may please the Court, my name is Tyler Akagi and I represent Nestle USA.

[00:14:23] Speaker 01:
I'd like to begin by following on to the comments just made by Mr. Fisher regarding what he characterized to be the nature of the invention disclosed in the 435 patent.

[00:14:37] Speaker 01:
The context of the prior art here for the patentability dispute is critical.

[00:14:42] Speaker 01:
Mr. Fisher pointed to different zones, partitions, and air flows as characterizing the 435 patent's invention, although none of those features are claimed.

[00:14:53] Speaker 01:
Critically, though, the prior art, Sholey teaches all of those features.

[00:15:00] Speaker 01:
It teaches a spray zone that you fill with a hydrogen peroxide mist, as Judge Rainier read from Sholey.

[00:15:07] Speaker 01:
It teaches a drying zone where sterilant is removed from the packages and removed from the system via vents.

[00:15:13] Speaker 01:
And it teaches the filling zone where the food stuff is packaged into the product.

[00:15:17] Speaker 01:
It also teaches partitions, just like the later 435 patent, specifically to

[00:15:23] Speaker 01:
allow the packages to pass through without allowing that sterile and mist also to pass through.

[00:15:29] Speaker 01:
And in addition, Mr. Fisher noted the airflow regimes and the Sholey reference discusses the same airflow regimes, the general idea of having a higher pressure air in the filling zone

[00:15:47] Speaker 01:
so that the air tends to go upstream and keeps things from migrating downstream.

[00:15:51] Speaker 01:
Specifically, that's Sholey, column six, lines about 37 to 42.

[00:15:59] Speaker 01:
So in the context of the prior art, which shows that the general conditions claimed in students' patent claims were known, the idea of having a higher concentration in the spraying zone than the filling zone.

[00:16:12] Speaker 01:
In fact, that point

[00:16:13] Speaker 01:
was not disputed by Steuben and its expert below, they conceded that Sholey would have some higher concentration in the spraying zone and the filling zone.

[00:16:24] Speaker 01:
The evidence also showed, as I just laid out, that the mechanisms used to achieve these general conditions also were known from Sholey.

[00:16:32] Speaker 01:
So against that backdrop, where the general conditions were known and the mechanisms were known, patentability question is whether it was obvious

[00:16:40] Speaker 01:
to have the particular sterile concentration ratios that Steuben claimed in its patents.

[00:16:46] Speaker 03:
So one of the questions here, putting aside the claim construction, and let's assume hypothetically that Steuben's claim construction were adopted, did the board find that Shelley rendered the claim obvious under that construction?

[00:17:07] Speaker 01:
It did.

[00:17:07] Speaker 01:
In fact, Your Honor, the board performed two alternative analyses.

[00:17:12] Speaker 01:
It conducted the analysis under the construction that it adopted, which we believe is correct, which is not limited to airborne concentration.

[00:17:21] Speaker 01:
But then the board did specifically analyze obviousness under the airborne concentration construction.

[00:17:28] Speaker 01:
That's the whole reason for the result-effective parameter analysis.

[00:17:32] Speaker 01:
There's no reason for that analysis under the board's construction

[00:17:35] Speaker 01:
which just looks at, look, you've got 30% concentration sterolint being sprayed in one zone, and you have less than 0.5 parts per million residual downstream.

[00:17:45] Speaker 01:
That's a 600,000 to one ratio.

[00:17:49] Speaker 01:
That, under the board's construction, it's very straightforward.

[00:17:53] Speaker 01:
The entirety of that result effective parameter analysis was directed to Steuborn's airborne construction.

[00:18:04] Speaker 01:
Mr. Fisher has argued that the prior art is silent as to the maintenance of any particular ratio if you construe the claims to require an airborne concentration.

[00:18:22] Speaker 01:
But that argument is wrong for a couple of reasons.

[00:18:25] Speaker 01:
First, the argument really is of no moment given the result effective

[00:18:31] Speaker 01:
parameter framework under which the board considered the evidence.

[00:18:35] Speaker 01:
Under this court's precedent, when the evidence shows that the general conditions claimed in the patent were known and that the mechanisms to achieve those conditions were known, then absent evidence of unpredictability or of criticality or some sort of unexpected result, those claims are obvious.

[00:18:56] Speaker 01:
It doesn't matter specifically what those numbers are.

[00:19:01] Speaker 01:
That framework says that as a matter of fact, when these general conditions are known, you don't get credit for a patent just for quantifying one of the values that fall within the sort of known normal operation of these devices.

[00:19:20] Speaker 01:
Well, I'm not sure that's true.

[00:19:23] Speaker 03:
I thought that the board was using the result effective parameter thing to say that you would.

[00:19:30] Speaker 03:
try to comply with the FDA regulations, and that's what it would lead you to.

[00:19:37] Speaker 03:
That it was result effective in the sense of there being an objective to comply with the FDA regulation.

[00:19:44] Speaker 01:
Well, I think that that's right, actually.

[00:19:46] Speaker 01:
I think that that's part of it.

[00:19:47] Speaker 01:
That's part of the result that the prior art knew that you needed to achieve.

[00:19:54] Speaker 01:
There are kind of two ends of this machine.

[00:19:57] Speaker 01:
One of the results that needs to be achieved

[00:19:59] Speaker 01:
is adequate sterilization.

[00:20:01] Speaker 01:
The prior art teaches you that you need to apply, for example, in sholey, a 30% concentration to achieve adequate sterilization.

[00:20:09] Speaker 01:
Dr. Heldman, Nestle's expert, testified that that level needs to be maintained.

[00:20:14] Speaker 01:
If you're going to get consistent sterilization, this is a continuous process.

[00:20:17] Speaker 01:
Each bottle needs to reach that level.

[00:20:21] Speaker 01:
And at the end of the system, you also need to maintain that residual level to achieve the FDA compliance

[00:20:27] Speaker 01:
And so it certainly factors into fact findings made by the board that led them to conclude that this was a result-effective parameter, that maintaining this ratio or maintaining this concentration was known and was result-effective, maintaining the residual concentration was known and was result-effective.

[00:20:48] Speaker 01:
The ratio logically follows, regardless of whether the prior art characterizes the two as in a specific relationship or not.

[00:20:57] Speaker 01:
when you maintain the two numbers, the ratio is also maintained.

[00:21:06] Speaker 01:
Mr. Fisher also made some arguments about whether there was substantial evidence to support a finding that the prior taught to maintain those ratios.

[00:21:27] Speaker 01:
As I noted, it doesn't matter if the priority tells you to maintain a ratio when the priority tells you to maintain the sterolink concentration for sterilization and the residual, the ratio naturally follows.

[00:21:39] Speaker 01:
And in making this finding, the board relied in part on the testimony from Dr. Heldman, who testified that it would be common sense to maintain the sterolink concentration that you're spraying because you want to get consistent sterilization of the bottle.

[00:21:55] Speaker 01:
That's the entire point.

[00:21:56] Speaker 01:
of these machines.

[00:21:59] Speaker 01:
And Steuben had taken issue in the briefing with Dr. Heldman's use of sort of a common sense assessment argued that you cannot use common sense to provide a claim limitation that's missing from the prior art.

[00:22:16] Speaker 01:
But that's not what happened here.

[00:22:17] Speaker 01:
The limitation is present in the art from the teachings of the sterile concentration to be applied and the residue to remain.

[00:22:25] Speaker 01:
Dr. Heldman's testimony was simply how a person of ordinary skill in the art would interpret those teachings.

[00:22:32] Speaker 01:
But in addition, there is also nothing that prevents common sense from being invoked to supply a missing limitation, even if the limitation were considered to be missing here.

[00:22:46] Speaker 01:
The case that Steuben cites is the Arendy case.

[00:22:53] Speaker 01:
which says that common sense may be invoked to supply a limitation if it's supported by evidence and a reasoned explanation.

[00:23:00] Speaker 01:
And those were both present here.

[00:23:08] Speaker 01:
I'd like to now turn to the board's claim construction and our belief that it is the correct construction.

[00:23:17] Speaker 01:
As

[00:23:20] Speaker 01:
The board's construction is the proper, broadest, reasonable interpretation because it accounts for the varied use of the sterolent concentration terms throughout the patent specification.

[00:23:33] Speaker 01:
As Judge Steick noted, the

[00:23:37] Speaker 01:
Some of the important concentrations in these systems are the concentration that you use to sterilize the bottles, the concentration of the sterolint that contacts the bottles and kills the bugs, as well as the sterolint concentration remaining, the residual concentration, because of its impact on food safety.

[00:23:58] Speaker 01:
And the patent specification, although it does discuss gas-laden sterolints, airborne sterolints in one paragraph,

[00:24:06] Speaker 01:
It also does discuss the importance of the sterilization aspect in the residue.

[00:24:11] Speaker 01:
At one point in column five, lines two through six, the patent says, the present invention uses hydrogen peroxide with a concentration of less than about 35% and ensures that the bottles have less than about 0.5 ppm of residual hydrogen peroxide after each bottle is sterilized.

[00:24:32] Speaker 01:
And the board's construction accounts for

[00:24:34] Speaker 01:
the varied use of concentration terms throughout the patent specification.

[00:24:41] Speaker 01:
The ward's construction also accounts for the prosecution history.

[00:24:44] Speaker 01:
At one point during prosecution, Steuben attempted to argue over a prior art reference, Kelbrick, which had some disclosures about the residual concentration as 0.5 part per million residual.

[00:24:58] Speaker 01:
And in a response to an office action, Steuben characterized that.

[00:25:04] Speaker 01:
as a sterolent concentration level.

[00:25:06] Speaker 01:
So clearly, during prosecution, Steuben did not consider that term to be limited only to airborne concentrations.

[00:25:14] Speaker 01:
And in addition, the board accounted for Steuben's infringement contentions in the parallel litigation, in which Steuben has cited the concentration of the liquid sterolent that Nestle uses to sterilize the bottles and the concentration of the residue remaining in those bottles

[00:25:33] Speaker 01:
as the basis for its allegations that Nestle satisfies these claims.

[00:25:38] Speaker 01:
Now, in its latest contentions, Steuben also argues that the sterilant is airborne at some point in the Nestle system, but it never argues that there is any particular airborne concentration in any particular zone.

[00:25:54] Speaker 01:
So at a minimum, Steuben's infringement contentions support that the board reach the right conclusion in interpreting the claims.

[00:26:24] Speaker 01:
Steuben has argued that the board failed to explain the rationale for rejecting Claim 3, which recites a 10,000 to 1 claim limitation.

[00:26:37] Speaker 01:
It depends from Claim 1, which recites the 5 to 1 claim limitation.

[00:26:42] Speaker 01:
But the premise for Steuben's argument is incorrect.

[00:26:47] Speaker 01:
Steuben did not separately argue for the patentability of Claim 3.

[00:26:50] Speaker 01:
It simply argued that its patentability arguments for claim one, which it called representative below, applied just as much to claim three, only more so.

[00:27:01] Speaker 03:
Moreover, under the board's result effective... They did mention claim three in their response.

[00:27:08] Speaker 01:
I'm sorry?

[00:27:09] Speaker 03:
They did mention claim three in their response.

[00:27:11] Speaker 03:
Correct.

[00:27:13] Speaker 01:
I think the mention of claim three was effectively that the

[00:27:19] Speaker 01:
sort of tacked on after a discussion of the concentration ratios generally.

[00:27:28] Speaker 03:
I mean, for example, on 26-22, to that end, it's readily apparent there'd be no reason to use a ratio as high as 10,001 as recited in claim three.

[00:27:38] Speaker 01:
Right.

[00:27:39] Speaker 01:
But that is simply an extension of the argument that it had made before with respect to the other claims.

[00:27:46] Speaker 01:
But I think that maybe a more important point is that the board's result effective parameter analysis is not tied to any specific limitation, any specific ratio under that analysis.

[00:28:01] Speaker 01:
the general conditions of the claims were known and the mechanisms to achieve those general conditions were known.

[00:28:08] Speaker 01:
And so the analysis applies regardless of whether the ratio is five to one or 10,000 to one or, you know, hypothetically a million to one, any ratio that Steuben might have claimed, unless there's evidence of unexpected results or criticality and the board found out.

[00:28:23] Speaker 01:
I'm not sure that's true.

[00:28:25] Speaker 03:
I think the board's decision probably has to be defended on whether

[00:28:30] Speaker 03:
prior art disclosed these ratios.

[00:28:36] Speaker 03:
And that you can use the result effective parameter to say that they did, but I don't think you can just pluck a parameter out of the air and say, well, because it's desirable to have some sort of parameter, you know, that their claim is obvious because they have a different parameter than was used in the prior art.

[00:29:01] Speaker 01:
Well, I think it wasn't just plucked out of the air.

[00:29:03] Speaker 01:
There were fact findings, as your Honor noted before, that Dr. Heldman, Nestle's expert, had testified that the concentration of sterilants sprayed into the air would be at 30 percent.

[00:29:15] Speaker 00:
And there was testimony from Steuben's expert in a prior proceeding explaining that when you... Are any of those fact findings sufficient to show a 10,000 to 1 ratio required by Claim 3?

[00:29:26] Speaker 01:
Yes.

[00:29:27] Speaker 01:
I'm out of time, but if I may respond.

[00:29:29] Speaker 01:
The fact finding relating to the consideration of students expert who analyzed what happens to the concentration of a liquid sterolint when it's turned into a spray.

[00:29:42] Speaker 01:
And that expert, according to his calculations, determined that a 30% concentration of liquid sterolint would be about 29.7% concentrate when turned into a spray.

[00:29:55] Speaker 01:
The reason is that air being so

[00:29:58] Speaker 01:
light having so little mass barely dilutes the concentration of the sterilant at all.

[00:30:03] Speaker 01:
So that is evidence that supports the board's analysis there.

[00:30:22] Speaker 04:
This final written decision issued before this court's guidance in Magnum Oil and runs a file of it in several respects.

[00:30:29] Speaker 04:
Most importantly and critically, I believe, is that the result effective parameter theory that we're discussing here is not Nestle's theory.

[00:30:40] Speaker 04:
It was not set forth in their petition.

[00:30:42] Speaker 04:
It was set forth by the board in the institutional decision.

[00:30:48] Speaker 03:
I think the board, when I was talking about result effective parameter, was just

[00:30:51] Speaker 03:
talking about the incentive to satisfy the FDA standards.

[00:30:56] Speaker 03:
That's, in my view, what they meant by that.

[00:30:58] Speaker 03:
But that wasn't the challenge in what the board did when it did that.

[00:31:01] Speaker 03:
Well, it's not a question of whether it's the challenge.

[00:31:03] Speaker 03:
It's the question of whether the ratios would be obvious to use these ratios.

[00:31:09] Speaker 03:
They said that, you know, it shows an upper ratio of 300,000 parts per million and that there would be a result effective parameter to try to achieve

[00:31:21] Speaker 03:
the FDA residual requirement, which would lead you to reduce that so that you got within the five to one ratio or the ratio of claim three.

[00:31:35] Speaker 04:
The initial matter in the board came forth in theory on behalf of Petitioner, but with the effect of doing the result effective parameter, pursuing the result effective parameter theory here is it shifted the burden to Steuben.

[00:31:50] Speaker 04:
patent owner to come forth with evidence of criticality and unexpected results where that burden should have been shouldered by Nestle in the petition to show that there was no criticality and no unexpected results.

[00:32:05] Speaker 04:
So the burden has been flipped, and under Magnum Oil that's improper, the burden should never shift to petitioner and an IPR, coming to the patent owner and IPR.

[00:32:14] Speaker 04:
I think we're out of time now.

[00:32:15] Speaker 04:
Thank you, Mr. Fisher.

[00:32:16] Speaker 04:
Thank both counsel and cases.