[00:00:00] Speaker 05:
versus Sherman Kingdom Way Group Company, case number 18-1892.

[00:00:33] Speaker 05:
I believe we're ready when you are, Mr. Nowak, and you reserve five minutes of your time for rebuttal.

[00:00:38] Speaker 05:
Yes, Your Honor, I did.

[00:00:39] Speaker 05:
Okay.

[00:00:41] Speaker 04:
All right.

[00:00:43] Speaker 04:
May it please the court, I will begin with the Daubert motion in this case, which was the reason for the district court summary judgment decision.

[00:00:59] Speaker 04:
The district court relied on

[00:01:02] Speaker 04:
four different types of evidence to reject Dr. Sherman's test results.

[00:01:08] Speaker 04:
I will talk about each of those reasons.

[00:01:12] Speaker 04:
First, the district court relied on cell viability tests done by Sendrew's employees, which allegedly showed that the cells would be alive up to 10 minutes following the application of hexane.

[00:01:28] Speaker 04:
Those tests were done in accordance with Conica's protocol.

[00:01:34] Speaker 04:
Dr. Sherman provided supplemental cell liability tests following the same protocol, which showed that the microorganisms remain alive, or I should strike that, were killed within 15 seconds after the application of solvent.

[00:01:53] Speaker 00:
Both... That solvent was hexane, right?

[00:01:56] Speaker 00:
I'm sorry?

[00:01:57] Speaker 00:
The solvent was hexane, right?

[00:01:59] Speaker 04:
The solvent was hexane in both cases, correct.

[00:02:04] Speaker 04:
The cell viability tests were done in the same way, under the same protocol.

[00:02:11] Speaker 04:
One showed that the cells were killed in 15 seconds, and one showed that the cells might not have been killed in 10 minutes.

[00:02:19] Speaker 04:
The court relied on the cell viability test done by Senju, which showed they could still be alive in 10 minutes.

[00:02:29] Speaker 04:
and rejected Dr. Sherman's test.

[00:02:32] Speaker 04:
Since the tests were done in the same way, the protocol was the same for both.

[00:02:38] Speaker 04:
This is clearly a question of fact for the jury to decide which set of tests was correct.

[00:02:45] Speaker 00:
Okay.

[00:02:46] Speaker 00:
Let me back up for a minute.

[00:02:48] Speaker 00:
Isn't it true that the problem here is that your expert altered the protocol that had been agreed to

[00:02:58] Speaker 00:
by both of the parties and the court, perhaps, for the protocol that was going to be used because he thought that one of the steps using ICE was unnecessary.

[00:03:09] Speaker 04:
Do I have that right?

[00:03:10] Speaker 04:
Yes, you do, Your Honor.

[00:03:12] Speaker 04:
Here's the situation.

[00:03:13] Speaker 04:
The plants that we respected are in Iter Mongolia.

[00:03:18] Speaker 04:
We had to ship, we had to have a mobile lab drive out to Inner Mongolia, ship all the material that we needed to do the test.

[00:03:26] Speaker 04:
And we, of course, we were never sure whether all the material was going to arrive and even if the mobile lab was going to get there on time.

[00:03:36] Speaker 04:
So the protocol was meant to cover any problem that we had with the supplies, for example, when we got to the plants in Inner Mongolia.

[00:03:47] Speaker 04:
When we got to Inner Mongolia, the defendants were cooperative.

[00:03:51] Speaker 04:
We were parked close to the places where we took the samples.

[00:03:56] Speaker 04:
So Dr. Sherman, in his experience of 35 years, and I can explain that to you, knew very well that immediately adding the solvent to the sample that we took would kill the microorganisms.

[00:04:13] Speaker 04:
Once the microorganisms were dead,

[00:04:15] Speaker 04:
there was no reason to use ice or shaking because once the microorganisms are dead, nothing can change.

[00:04:25] Speaker 04:
The reduced value can no longer change.

[00:04:27] Speaker 04:
So the two points you make about using ice and shaking is not necessary if the solvent kills the hexane upon contact.

[00:04:39] Speaker 04:
And that was Dr. Sherman's belief.

[00:04:40] Speaker 05:
It was your expert, Dr. Sherman, who actually created

[00:04:44] Speaker 05:
protocol.

[00:04:44] Speaker 05:
That is correct.

[00:04:45] Speaker 05:
And he went on to violate that very protocol.

[00:04:48] Speaker 04:
Well, as I said, Your Honor, the purpose of the protocol was to have everything down on paper.

[00:04:56] Speaker 04:
For example, the solvent that we needed to add to the microorganisms very likely could not have arrived.

[00:05:02] Speaker 04:
And in that case, we would have used ice.

[00:05:05] Speaker 04:
Keep in mind, please, in the ITC,

[00:05:09] Speaker 04:
that Conica was criticized for using ice and not freezing the microorganisms.

[00:05:16] Speaker 04:
So even if we wanted to use ice, their own experts said that the ice would not have an effect for 35 minutes, 25 or 30 minutes.

[00:05:28] Speaker 04:
We were five minutes from the mobile lab where we did the test.

[00:05:34] Speaker 00:
You agree that it would have been ideal had your expert just used the ice, even if he thought it was irrelevant, right?

[00:05:40] Speaker 04:
I'm sorry, say that again.

[00:05:40] Speaker 00:
I said you agree though it would have been a lot easier had your expert just used the ice and followed the protocol, even if he thought it was unnecessary.

[00:05:49] Speaker 00:
Then you wouldn't be here, right?

[00:05:52] Speaker 00:
I mean, I understand your point.

[00:05:53] Speaker 00:
Your point is that, as I understand it, you're saying there's enough indicia here to show that his

[00:06:01] Speaker 00:
method was scientifically viable enough that at least it should have garnered the jury.

[00:06:07] Speaker 04:
Yes, Your Honor, and I would like to explain to you why he knew very well that the microorganism would, that someone would kill the microorganisms.

[00:06:19] Speaker 04:
Let me go right to that section.

[00:06:23] Speaker 04:
This is another reason why the district court rejected Dr. Sherman's test results.

[00:06:29] Speaker 04:
And that was based on that Sherman's findings were not based on selling science.

[00:06:35] Speaker 04:
That is your ice and shaking issue, right?

[00:06:39] Speaker 04:
In response to that rejection, Dr. Sherman provided a declaration stating he had 35 years experience as a microbiologist.

[00:06:49] Speaker 04:
And during those 35 years, he had thousands of times used solvent to kill microorganisms.

[00:06:56] Speaker 04:
The solvent included hexane.

[00:06:59] Speaker 04:
in the microorganisms included rotobacter spariotis.

[00:07:04] Speaker 04:
Based on this pre-litigation research, Dr. Sherman stated in his declaration that there's no question applying a solvent mixture 215 times greater than what was set forth in the defendant's peer review papers would clearly kill the microorganisms.

[00:07:28] Speaker 04:
Let me back up one moment and say, a peer review paper provided by the defendant said, microorganisms may still be alive when you apply solvent at a ratio of 0.1%.

[00:07:39] Speaker 00:
And that was for a certain kind of microorganisms, is that right?

[00:07:43] Speaker 00:
I'm sorry?

[00:07:43] Speaker 00:
Wasn't that for a certain kind of microorganisms?

[00:07:47] Speaker 04:
It was a number of different microorganisms, right?

[00:07:50] Speaker 04:
But the district court judge relied on their peer review papers to reject Dr. Sherman's test results.

[00:07:59] Speaker 04:
In the peer review papers provided by the defendants, if you applied solvent at a 1% level, the cells were killed.

[00:08:08] Speaker 04:
So the argument that Dr. Sherman is making, we provide solvent at a level 215 times greater than what was in the defendants' peer review papers, and those peer review papers said that the microorganisms would die at 1%.

[00:08:24] Speaker 00:
Can I ask you, just to make sure I understand the articles you're referring to, these are the articles that refer to extremophiles?

[00:08:32] Speaker 00:
Yes.

[00:08:32] Speaker 00:
And so there's also dispute as to whether hexane is in fact an extremophile.

[00:08:36] Speaker 00:
Is that correct?

[00:08:39] Speaker 04:
We provided papers, peer review papers, that says hexane is an extremely volatile solvent.

[00:08:46] Speaker 04:
It dissolves the cell membrane and kills the cells.

[00:08:50] Speaker 04:
That's on the papers we provided.

[00:08:53] Speaker 04:
Right.

[00:08:54] Speaker 00:
I understand.

[00:08:55] Speaker 00:
I'm just trying to make sure I understood.

[00:08:57] Speaker 00:
I was trying to figure out which articles you were referring to.

[00:09:00] Speaker 04:
Yes.

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

[00:09:01] Speaker 04:
All right.

[00:09:01] Speaker 04:
So the point we're making is the district court said, relied on the defendant's papers showing that the microorganisms could be killed at a, could still be alive at a 0.1% level.

[00:09:20] Speaker 04:
Dr. Sherman, based on his pre-litigation experience and the fact that we were using 215 times that level of 1%, that the microorganism would have been killed immediately.

[00:09:33] Speaker 04:
That is why we did not use ice or shaking during the test, because there was no need to do that.

[00:09:42] Speaker 04:
Dr. Sherwood has shown by his 35 years of experience as a microbiologist that when you add the cell... Is there any other evidence that you produced that would corroborate what you just told?

[00:09:52] Speaker 04:
I'm sorry?

[00:09:52] Speaker 05:
Is there any other evidence that you produced that would corroborate that there was no need to use the ice or... The best evidence is the defendant's own papers where they showed microorganisms were killed at a 1% level

[00:10:06] Speaker 04:
And when we added solvent, it was 215 times that.

[00:10:09] Speaker 00:
What about the testimony of Dr. Taylor and Dr. Leventz from the other litigations, where they testified that you could either use solvent or use ice in order to stop the metabolic activity?

[00:10:22] Speaker 04:
Yes.

[00:10:22] Speaker 04:
Yes, of course.

[00:10:24] Speaker 04:
You could use a solvent.

[00:10:25] Speaker 04:
If you look at the ITC decision, I don't know if you read that,

[00:10:29] Speaker 04:
There are three ways to do this.

[00:10:31] Speaker 04:
You use solvent.

[00:10:32] Speaker 04:
You could use ice.

[00:10:32] Speaker 04:
Ice slows down the rate of... How can I say this?

[00:10:40] Speaker 04:
Solvent kills the microorganisms immediately.

[00:10:44] Speaker 04:
Adding freezing will kill the microorganisms, so the reduced level won't change.

[00:10:49] Speaker 04:
If you add ice, it'll slow down the process.

[00:10:52] Speaker 04:
But there will still be an increase in the reduced level, and that is not proper, because you take the measurement,

[00:10:59] Speaker 04:
And you don't want the reduced level to change as the sample is stored and then tested later.

[00:11:05] Speaker 04:
That's why using ICE was criticized in the ITC, directly criticized.

[00:11:10] Speaker 04:
That's one major reason why Conica had to build a mobile lab to get it close to the point where we took the samples.

[00:11:19] Speaker 04:
Because getting the sample and shipping it off to a lab in a way that's unprotected would change the

[00:11:28] Speaker 04:
the reduced level.

[00:11:29] Speaker 00:
I'd like to ask you about claim construction.

[00:11:31] Speaker 04:
I'm sorry?

[00:11:32] Speaker 00:
I'd like to ask you about claim construction.

[00:11:34] Speaker 00:
So one of the things that you argue is you say that the district court reinterpreted our interpretation of the claim of the term sealed tank.

[00:11:45] Speaker 00:
But isn't it fair maybe to say that what the district court actually did was look at the term sealed tank and how we interpreted it in the context of the entire claim phrase

[00:11:55] Speaker 00:
which talks about extraction in a sealed tank.

[00:12:00] Speaker 00:
So isn't it most fair to read the District Court's construction as being simply an understanding of the entire phrase in light of the Federal Circuit's interpretation of sealed tank?

[00:12:11] Speaker 04:
Your Honor, the District Court added a one-way check valve

[00:12:17] Speaker 00:
It said that you have to have the extraction, the entirety of the extraction has to be in a sealed tank, right, as defined by the Federal Circuit.

[00:12:28] Speaker 00:
The meaning of sealed tank is defined by the Federal Circuit.

[00:12:32] Speaker 00:
And then there was the discussion of the one-way valve and the two-way valve.

[00:12:36] Speaker 00:
Do you understand what my question is?

[00:12:38] Speaker 00:
Because I think that the whole claim phrase says in extraction in a sealed tank,

[00:12:47] Speaker 00:
And so from that, you could say that the district court understood that the entire phrase required that there be, during the entirety of the extraction, there would be no exposure of the contents of the tank to the atmosphere.

[00:13:03] Speaker 04:
Well, Judge Otero in California was required to follow the claim construction that was reached by this court in the Kington Way decision.

[00:13:11] Speaker 04:
I mean, that's my understanding.

[00:13:12] Speaker 04:
That's the law of the case.

[00:13:14] Speaker 00:
But isn't it true, though, that even if the appellate court has a particular claim construction of one term, that doesn't prohibit the district court from interpreting a whole limitation that includes that one term, right?

[00:13:29] Speaker 04:
Well, Your Honor, he significantly changed the claim construction by adding

[00:13:39] Speaker 04:
a one-way check valve that would continually release hexate into the atmosphere, which is bad for everybody in the plant, and then during the filling process, but prevent air from entering the tank.

[00:13:54] Speaker 04:
And what he said about that is, again, his conclusion was that his construction was fully consistent with the patent specification, which discloses that at least with respect to reduced Q10, the primary concern during extraction is preventing oxidation.

[00:14:14] Speaker 04:
When we're making oxidized Q10, we don't care about oxidation of the reduced Q10.

[00:14:19] Speaker 04:
Our goal is to get everything oxidized by the end of the process.

[00:14:25] Speaker 04:
So that's the confusion with the definition of sealed tank.

[00:14:31] Speaker 04:
The extraction tank is towards the end of the process, right?

[00:14:36] Speaker 04:
The reduced Q10 is made before that.

[00:14:39] Speaker 04:
Once it reaches a certain level, we want it to be oxidized.

[00:14:43] Speaker 00:
Can I ask you a separate question?

[00:14:44] Speaker 00:
When do you think extraction starts?

[00:14:50] Speaker 04:
That's a very good question, Your Honor.

[00:14:52] Speaker 04:
All right.

[00:14:53] Speaker 04:
Extraction can either start, and it depends upon the definition, extraction can start when the solvent touches the microorganisms, or it can start when the stirring starts, because then you're circulating the extraction or the solvent throughout the material in the tank.

[00:15:10] Speaker 04:
There have been testimony two ways on that.

[00:15:13] Speaker 00:
Okay.

[00:15:13] Speaker 04:
All right.

[00:15:14] Speaker 04:
Our position is extraction starts when the solvent enters the tank.

[00:15:23] Speaker 05:
All right.

[00:15:24] Speaker 05:
Okay, Mr. Norrack.

[00:15:25] Speaker 05:
You almost used up all your rebuttal time.

[00:15:27] Speaker 05:
If you stop now, I can give you some rebuttal time later.

[00:15:31] Speaker 05:
Okay.

[00:15:32] Speaker 05:
Let me reserve it for rebuttal.

[00:15:34] Speaker 05:
Okay.

[00:15:34] Speaker 05:
Mr. Nidich.

[00:15:43] Speaker 05:
Is it NADIC?

[00:15:44] Speaker 05:
NADIC.

[00:15:45] Speaker 05:
NADIC.

[00:15:46] Speaker 01:
Good morning, Your Honors.

[00:15:48] Speaker 01:
May it please the Court?

[00:15:51] Speaker 01:
I'd like to start with the seal tank issues first and then move on to the Daubert ruling.

[00:15:56] Speaker 01:
And I would like to start the seal tank argument by... These are independent grounds for affirmance in your view, correct?

[00:16:04] Speaker 01:
Yes.

[00:16:10] Speaker 01:
The Daubert ruling didn't cover the

[00:16:13] Speaker 01:
Old process.

[00:16:15] Speaker 01:
Kingway has a new process and an old process.

[00:16:17] Speaker 02:
OK, so they really aren't independent grounds.

[00:16:18] Speaker 01:
Yes.

[00:16:18] Speaker 02:
They're covered.

[00:16:20] Speaker 02:
Daubert doesn't get you all the way home.

[00:16:22] Speaker 02:
You need seal tank.

[00:16:23] Speaker 01:
Yes, Your Honor.

[00:16:24] Speaker 01:
All right.

[00:16:24] Speaker 01:
I'd like to begin by addressing the question you just asked, Judge Stoll, which is when does extraction begin?

[00:16:31] Speaker 01:
And there are experts submitted.

[00:16:34] Speaker 01:
I think both parties are actually in agreement, because their experts submitted a declaration.

[00:16:38] Speaker 01:
And it's on appendix page 4597.

[00:16:42] Speaker 01:
Paragraph 13, he says, a person of ordinary skill in the art would understand that extraction would start when the microorganisms containing coenzyme Q10 are exposed to organic solvent, including anhexane.

[00:16:59] Speaker 01:
And the reason that that's important is that... Because the valve is open at that time.

[00:17:03] Speaker 01:
It's open.

[00:17:05] Speaker 01:
The extraction doesn't occur in an instant.

[00:17:08] Speaker 01:
It takes a certain duration of time.

[00:17:10] Speaker 01:
It starts when the valve is open, and the extraction ends when the CoQ10 actually comes out of the cells.

[00:17:17] Speaker 00:
One of the things I'm struggling with is just the plain language extracting the oxidized coenzyme Q10 by an organic solvent in a sealed tank.

[00:17:29] Speaker 00:
How do we go from that language to its

[00:17:33] Speaker 00:
in a sealed tank during the entire extraction process, which I understand to be multiple hours long.

[00:17:40] Speaker 00:
I understand that your valve is open for a certain period of time at the beginning of that process, but then it's closed.

[00:17:47] Speaker 00:
Well, why should we interpret this claim and understand it to require that it has to be sealed or in a sealed tank during the entirety of the extraction process when the claim says nothing about entirety?

[00:18:01] Speaker 01:
Well, I would say this, that when you realize that extraction doesn't just happen in an instant, it takes place over a period of time.

[00:18:09] Speaker 01:
And, you know, the extraction when it begins, it's exposed to the atmosphere because a relief valve is open, happens over a period of time.

[00:18:20] Speaker 01:
So there's not going to be even one cell microorganism that's extracted completely.

[00:18:25] Speaker 01:
All of the cells are at the beginning exposed to the atmosphere.

[00:18:30] Speaker 01:
And then if you look at the, we differ on this, but I think the whole reason for a sealed tank is to prevent oxygen.

[00:18:37] Speaker 01:
you want to prevent oxygen from coming into the tank.

[00:18:40] Speaker 01:
So if you're letting oxygen into the tank, you're sort of defeating the purpose of having a sealed tank.

[00:18:46] Speaker 01:
It's a little bit like if I have a pot on the stove and I take the top on and off, it's not sealed.

[00:18:52] Speaker 01:
You're not cooking well sealed if you take it on and off.

[00:18:55] Speaker 02:
No, but if you take it off just for a moment and put it back on, you probably end up with the same efficient cooking that you would have had if you just didn't take it off for just a second.

[00:19:03] Speaker 01:
Well, I guess I would argue that it's really a doctrine of equivalence argument they're making that it's sealed most of the time or it's sealed some of the time.

[00:19:11] Speaker 02:
Well, it would be doctrine of equivalence if the claim said throughout the time in the infringing, the accused infringing device did it almost all the time, but just popped the valve open.

[00:19:23] Speaker 02:
But here the whole question is what does the claim mean?

[00:19:26] Speaker 01:
Right.

[00:19:27] Speaker 02:
So it's not really doctrine of equivalence.

[00:19:29] Speaker 01:
Well, I guess my argument would be that, I mean, I think that if you're extracting, and we all agree that it starts when things open, there are experts in agreement with that, that you're defeating the purpose of the claim if you're leaving the pot open or the tank open some of the time.

[00:19:50] Speaker 00:
Why are we talking about their accused product to interpret the claim?

[00:19:53] Speaker 00:
I mean, shouldn't we be talking about the intrinsic evidence?

[00:19:56] Speaker 00:
What is the intrinsic evidence to support the idea that it has to be in a sealed tank during the entire extraction process?

[00:20:06] Speaker 01:
Well, the intrinsic evidence would be that

[00:20:15] Speaker 01:
that the patent talks about protecting from an oxidation reaction.

[00:20:22] Speaker 01:
And I think that's really the only support for adding that sealed tank limitation.

[00:20:26] Speaker 01:
And actually, the plain language of this quartz construction is, in a lot of cases, this quartz construction, which is you're protecting the contents of the tank from the atmosphere.

[00:20:38] Speaker 01:
So, and that's based on, you know, the description in the patent of example eight where it's talking about sealing under a nitrogen gas.

[00:20:49] Speaker 01:
So you're using nitrogen gas and you are deoxygenating atmosphere.

[00:20:53] Speaker 01:
Why are you doing that?

[00:20:54] Speaker 01:
You're trying to prevent oxygen from getting into the tank.

[00:20:57] Speaker 00:
When it talks about continuous extraction as well, and do I understand correctly that during that continuous extraction in the process of figure eight,

[00:21:07] Speaker 00:
You're going from one tank to another.

[00:21:10] Speaker 00:
Is it moving during that continuous extraction process?

[00:21:13] Speaker 01:
I think it is moving from one tank to the other.

[00:21:16] Speaker 00:
So we have to understand that the valves and all of those situations, everything's always during the entire extraction process in Figure 8, it's constantly sealed from the atmosphere?

[00:21:26] Speaker 01:
Yes, and I think the patent is clear about that.

[00:21:29] Speaker 01:
You don't want it, it puts a nitrogen gas.

[00:21:32] Speaker 00:
Can you identify for me where that is?

[00:21:40] Speaker 01:
Well, I should say, the patent's clear about protecting from an oxidation reaction, but I will point you to... Okay, so on column 16, starting at line 16 is the patent... What page are you on?

[00:21:59] Speaker 01:
Oh, I'm on, sorry, I'm on appendix page 395.

[00:22:11] Speaker 01:
Okay.

[00:22:13] Speaker 01:
So starting at line 16, I mean column 16, line 16, and going to around line 39 is the discussion of when you recover the CoQ10, either through extraction and or disruption, you're trying to protect from an oxidation reaction.

[00:22:41] Speaker 01:
And then when you get down to around line 35, it's talking about, for example, you could use a deoxygenated atmosphere, such as an inert gas, such as nitrogen.

[00:22:52] Speaker 01:
Now, I'm not saying you have to.

[00:22:54] Speaker 00:
Wait, where are you?

[00:22:54] Speaker 01:
Oh, okay, I'm on line 30.

[00:22:57] Speaker 01:
Okay, so I'll read 36.

[00:22:58] Speaker 01:
Okay.

[00:22:59] Speaker 01:
It says, for example, a deoxygenated atmosphere, an atmosphere of an inert gas, such as nitrogen gas, carbon dioxide gas, dot, dot, dot.

[00:23:11] Speaker 01:
That's what it's talking about.

[00:23:13] Speaker 00:
That says, for example, right?

[00:23:15] Speaker 00:
Right.

[00:23:16] Speaker 00:
Even the language up above says, preferably.

[00:23:20] Speaker 01:
OK, well, so here it's saying that's an example of how to protect.

[00:23:24] Speaker 01:
There's other ways to protect.

[00:23:25] Speaker 01:
OK, but then I'll go to my next site, which is column 23.

[00:23:33] Speaker 01:
And this is actually a description of Example 8 that the court relied on in its previous opinion.

[00:23:39] Speaker 01:
precisely what it construed the sealed tank based on.

[00:23:43] Speaker 01:
And so if you look at column 23, line 20, it starts the sentence saying the obtained cells were disrupted for two times.

[00:23:52] Speaker 01:
So it's talking about cell disruption there.

[00:23:55] Speaker 01:
And then if you go down a few lines to line 22 or 23, it says it's sealed with nitrogen gas to obtain a cell-disrupted solution.

[00:24:08] Speaker 01:
What the Federal Circuit said, and that's the key line that it relied on in its previous opinion to construe sealed tank.

[00:24:14] Speaker 01:
It says, the concern with the patent is not sealing with respect to solvents, it's sealing with respect to the atmosphere.

[00:24:24] Speaker 01:
And if you look at this passage where you're sealing with nitrogen gas, and you'll recall from the previous paragraph I cited, it's talking about you use the nitrogen gas to seal from the atmosphere.

[00:24:35] Speaker 01:
And this is the very passage the court relied on

[00:24:37] Speaker 01:
when construing sealed tank.

[00:24:39] Speaker 01:
So my point is, the whole purpose of the sealed tank, why they added this during prosecution to overcome the prior art, was to protect from an oxidation reaction, to protect from the atmosphere.

[00:24:54] Speaker 01:
I'm sorry, I don't know where the time... You got five minutes.

[00:24:57] Speaker 00:
Okay.

[00:24:58] Speaker 00:
So as I understand it then, the idea is this, is that

[00:25:02] Speaker 00:
You can't be protected from the atmosphere or have extraction in a sealed tank unless that entire extraction process is in a sealed tank.

[00:25:11] Speaker 01:
Yes.

[00:25:12] Speaker 01:
And one other point I want to make is they really stipulated to non-infringement on two separate grounds.

[00:25:18] Speaker 01:
So what they call in their brief, they call it the timing limitation and the venting limitation.

[00:25:23] Speaker 01:
But really, what we were discussing is what they call the timing limitation.

[00:25:26] Speaker 01:
The other grounds that they stipulated on

[00:25:29] Speaker 01:
are that the district court said oxygen is not allowed to enter the tank.

[00:25:34] Speaker 01:
It's OK to leave the tank, but air from the atmosphere is not allowed to enter the tank.

[00:25:39] Speaker 00:
That's the one-way versus two-way valve discussion, right?

[00:25:42] Speaker 00:
Yes.

[00:25:42] Speaker 01:
OK.

[00:25:43] Speaker 01:
And they stipulated on separate grounds.

[00:25:46] Speaker 01:
And that may even be the clearer basis.

[00:25:49] Speaker 01:
I mean, it was discussed quite a bit in the previous bill.

[00:25:50] Speaker 00:
Show me where, because I was looking through this stipulated judgment and trying to understand.

[00:25:54] Speaker 00:
Can you show me where you think your best support is for what you've just said?

[00:25:59] Speaker 01:
Appendix page 4636.

[00:26:15] Speaker 01:
And then I'm looking at paragraph, it's paragraph 13, sub-numeral 2.

[00:26:22] Speaker 01:
And starting, it's really A through D.

[00:26:31] Speaker 01:
So A specifically relates to the idea that you're protecting the contents of the tank from the atmosphere and not the atmosphere to the tank.

[00:26:39] Speaker 01:
Then B talks about oxygen is not allowed to enter the tank.

[00:26:45] Speaker 01:
They're quoting from the district court's ruling.

[00:26:47] Speaker 00:
But aren't they here just repeating what the court's construction was?

[00:26:51] Speaker 01:
Yes.

[00:26:52] Speaker 01:
So then you have to look at paragraph 14 where they say, paragraph 14 and 15 they say, we don't agree with the court's construction and for that reason we don't infringe.

[00:27:01] Speaker 01:
I'm paraphrasing, but you have to take the paragraphs in combination.

[00:27:07] Speaker 02:
So are you reading the stipulation then as putting the plaintiffs in a position that if they're right, that the construction was wrong, but it was only wrong with respect to one of the two points that they disputed, that they lose?

[00:27:29] Speaker 01:
Yes, either way they lose.

[00:27:32] Speaker 02:
Even though what they have stipulated to is that we can test the construction, not we can test the construction on each separable element of the construction.

[00:27:46] Speaker 01:
Well, the timing limitation applies to the relief valve, which is open.

[00:27:52] Speaker 01:
But this venting limitation doesn't really make any difference with respect to the relief valve because it can come in and out.

[00:27:57] Speaker 01:
That relates to the condenser.

[00:27:59] Speaker 02:
No, but there are two elements then that are in dispute dealing with the claim construction.

[00:28:05] Speaker 02:
And it looks to me like they are simply saying, we stipulate that if the district court is right with respect to the claim construction, we would lose.

[00:28:15] Speaker 02:
But that seems to me to be unitary, not binary.

[00:28:21] Speaker 01:
Well, I tried to include for context what the actual system does.

[00:28:26] Speaker 01:
And I think it's clear that if, for example, if they lose on the oxygen, their argument with respect to the condenser is that the solvent condenses.

[00:28:38] Speaker 01:
It prevents the solvent from getting out into the atmosphere.

[00:28:40] Speaker 01:
But air can come in and air can come out.

[00:28:43] Speaker 01:
But their position is it fringes.

[00:28:45] Speaker 01:
The accused plant infringes.

[00:28:48] Speaker 01:
simply because it prevents solvent from leaving the plant?

[00:28:52] Speaker 02:
My recollection of the record, and I can't find it in the record now, I'm sure you know where it is, but that not only was there evidence that, and I think this was from both sides, that the extraction starts when the solvent hits the Q210 right away, the enzyme.

[00:29:17] Speaker 02:
Is there also evidence that the extraction, the bulk of the extraction occurs in the very first few minutes?

[00:29:25] Speaker 01:
Yes.

[00:29:25] Speaker 02:
Something to that effect?

[00:29:27] Speaker 01:
Yes.

[00:29:28] Speaker 01:
Do you remember where that is?

[00:29:28] Speaker 01:
There's expert testimony on that.

[00:29:30] Speaker 01:
I can find it quickly in my red brief.

[00:29:40] Speaker 02:
OK.

[00:29:40] Speaker 02:
This may not go directly to the question of claim construction, but I'd be curious to see what it is.

[00:29:58] Speaker 01:
Okay, so I have a statement in my red brief.

[00:30:01] Speaker 01:
It says the solvent extracts the CoQ10 quickly within minutes of contacting the powder.

[00:30:07] Speaker 02:
What's the site for that?

[00:30:08] Speaker 01:
It's 4914.

[00:30:08] Speaker 01:
Okay.

[00:30:12] Speaker 01:
And I believe there's another site as well that I can find.

[00:30:20] Speaker 01:
Oh, yeah.

[00:30:20] Speaker 01:
That's the... It starts at line 24 on that page.

[00:30:27] Speaker 00:
Right.

[00:30:29] Speaker 00:
This is on page 4914.

[00:30:31] Speaker 00:
Is this somebody's testimony?

[00:30:33] Speaker 00:
Whose testimony is this?

[00:30:34] Speaker 01:
Yes, this is testimony from the ITC.

[00:30:42] Speaker 01:
And it is... I think this is a corporate representative for... I'm not sure.

[00:30:59] Speaker 01:
Let me see if I can find the other site.

[00:31:09] Speaker 02:
This was introduced into the record in this case?

[00:31:12] Speaker 01:
Yes, this is part of the record.

[00:31:16] Speaker 01:
And then there's another site at 5451, paragraph 234.

[00:31:22] Speaker 01:
This is from an expert report.

[00:31:27] Speaker 01:
The expert just says it's his understanding that most is extracted when the tank is not sealed.

[00:31:37] Speaker 01:
What was the site that you just gave?

[00:31:40] Speaker 01:
It's a 5-4-5-1.

[00:31:41] Speaker 00:
Thank you.

[00:31:43] Speaker 01:
Paragraph 234.

[00:31:44] Speaker 01:
Yes.

[00:31:46] Speaker 01:
This is our expert report.

[00:31:52] Speaker 01:
Okay.

[00:31:55] Speaker 01:
I wanted to return to the point that in our system, the air can come in and out of the condensers.

[00:32:03] Speaker 01:
And they have stipulated, based on the portions I have, that if air comes into the tank, I believe there's no infringement, and the whole appeal should be able to be infringed on that grounds alone.

[00:32:14] Speaker 01:
I'll switch to the Daubert ruling.

[00:32:19] Speaker 05:
You're out of time, but you can very briefly address it, Albert.

[00:32:24] Speaker 01:
I'll just say that there were a number of deficiencies that were already discussed by the court in these questions.

[00:32:31] Speaker 01:
To fill those deficiencies, Kanaka tried to submit objective evidence very late after the experts had

[00:32:40] Speaker 00:
What about the other evidence that they submitted other than those articles or I guess not the articles but the testing that they had done.

[00:32:49] Speaker 00:
What about the other evidence including that I can't remember the exact number but the expert had been working in this field for 35 years and said that he had used a solvent in this way on other had used on other microorganisms I think he said thousands of times or hundreds of times.

[00:33:07] Speaker 00:
I don't recall and doesn't Albert say that

[00:33:10] Speaker 00:
One of the things you should look at in determining whether something is scientifically reliable or not is whether the expert themselves had used the technique and issue outside of the context of litigation.

[00:33:23] Speaker 01:
Yes, but what the district court found, and I believe he was correct, is that in these circumstances, you can't just rely on the experts say so.

[00:33:31] Speaker 01:
It's ipsa dixit.

[00:33:33] Speaker 01:
When you have, first of all, the defendants did testing, which shows that the solvent doesn't kill it immediately.

[00:33:39] Speaker 01:
And he said in his own protocol that he was going to use an ice bucket.

[00:33:46] Speaker 01:
Our expert handed him an ice bucket in protest and said, no, we don't want to use an ice bucket.

[00:33:52] Speaker 01:
So when you take all of the circumstance, and our testing showed that it makes a big difference whether or not you use ice.

[00:33:59] Speaker 00:
I understand what you're saying.

[00:34:00] Speaker 00:
What about Dr. Taylor and Dr. Levense's expert testimony?

[00:34:05] Speaker 00:
We're both, I understand,

[00:34:08] Speaker 00:
and positions opposed to Koneka, who also said, you know, if you want to stop the metabolism, you could either use a solvent or use ice.

[00:34:22] Speaker 01:
Well, they're right.

[00:34:24] Speaker 01:
I mean, you can use ice to stop it.

[00:34:27] Speaker 01:
That's our position is that you use, they should have used ice.

[00:34:29] Speaker 00:
The question is whether you could use solvent.

[00:34:31] Speaker 00:
I mean, the point is, is that if there's, you know, I understand your position.

[00:34:36] Speaker 00:
I'm just wondering whether, given his experience where he says he's done it thousands of times, it's not just Ipsy Dixit.

[00:34:42] Speaker 00:
It's not just him saying, well, I say so.

[00:34:44] Speaker 00:
It's saying, I've done this before.

[00:34:47] Speaker 00:
And then also, you've got expert testimony.

[00:34:50] Speaker 00:
And then you've got, in addition to that, the district court's findings on rejecting the indefiniteness defense.

[00:34:57] Speaker 01:
You can use solvent, but there's a lot more to it.

[00:35:01] Speaker 01:
There's a question of, did you mix it?

[00:35:02] Speaker 01:
Did you shake it?

[00:35:04] Speaker 01:
How quickly does it kill it?

[00:35:05] Speaker 01:
I mean, you can tell from our seal tank arguments, there's solvent there, but it's not killing them immediately.

[00:35:11] Speaker 01:
It takes a while.

[00:35:12] Speaker 01:
Even they don't want it to kill it immediately for purposes of that term, so it's not just a simple matter of The real question is does the solvent kill it immediately such that you don't need ice for the five minutes?

[00:35:25] Speaker 05:
It takes to transport the samples Okay, thank you I'm gonna restore it to three minutes of time three if you need if you need it Okay, so first I want to clarify argument that

[00:35:43] Speaker 04:
The patent shows that a sealed tank is to prevent oxygen from coming into the tank.

[00:35:50] Speaker 04:
Okay?

[00:35:51] Speaker 04:
So first, let's go to the patent itself.

[00:35:54] Speaker 04:
I think that begins at 384.

[00:35:59] Speaker 04:
And go to column 16.

[00:36:17] Speaker 04:
There, they cited column 16, but if you look at the beginning, at line 13, 14, that's for recovering reduced Q10, not oxidized Q10.

[00:36:28] Speaker 04:
I know this is difficult to understand.

[00:36:29] Speaker 04:
The patent when it was written covered both reduced and oxidized.

[00:36:33] Speaker 04:
They are two different products.

[00:36:35] Speaker 04:
Reduced Q10 has to be protected from oxidation because you want to recover reduced Q10 at the end of the process.

[00:36:43] Speaker 04:
Oxidized Q10, you don't care about oxidation because you want it to be fully oxidized.

[00:36:49] Speaker 04:
The product, you can buy Q10, the oxidized version, and you can buy reduced Q10, which I take every day because it's better.

[00:36:57] Speaker 04:
So the patent itself described both processes, right?

[00:37:03] Speaker 04:
And since we're talking about making oxidized Q10, which the defendants make, the reduced Q10 does not have to be protected from an oxidation reaction.

[00:37:13] Speaker 04:
All right, he also mentioned example eight, right?

[00:37:17] Speaker 02:
You mean the oxidized Q10 doesn't have to be protected.

[00:37:20] Speaker 02:
I'm sorry?

[00:37:20] Speaker 02:
You said the reduced doesn't have to be protected.

[00:37:22] Speaker 02:
You mean the oxidized doesn't have to be protected.

[00:37:23] Speaker 04:
Oxidized, I'm sorry, doesn't have to be protected, yes.

[00:37:26] Speaker 04:
Let's go to example eight at column 23.

[00:37:33] Speaker 04:
where my opponent said that because they're talking about sealing and adding nitrogen and so forth, and that the Federal Circuit relied on that.

[00:37:48] Speaker 04:
Example eight is talking about a pressure homogenizer which uses nitrogen gas to obtain a cell-disrupted solution.

[00:37:59] Speaker 04:
The pressure homogenizer, which is on one, two, three, four,

[00:38:02] Speaker 04:
the fifth line from the top, that's which disrupts the cells.

[00:38:07] Speaker 04:
It has nothing to do with extraction or seal tank.

[00:38:12] Speaker 04:
And indeed, Kingdom Way in their appellate brief in the Kingdom Way case on page 24 of their opposition brief said, and I quote,

[00:38:29] Speaker 04:
The only use of the word sealed in the written description is in the context of a pressure homogenizer sealed with natural gas to obtain a cell-disrupted solution in example eight.

[00:38:41] Speaker 04:
This is what they argued to the court.

[00:38:43] Speaker 04:
However, the pressure homogenizer was a piece of equipment used for the physical disruption of microbial cells, not extraction, and therefore this isolated use is unrelated to the way sealed is used in the claims.

[00:38:57] Speaker 04:
Example eight.

[00:38:59] Speaker 04:
has nothing to do with seal tank.

[00:39:01] Speaker 04:
Now, the Federal Circuit, yes, in the Kingdom Way decision, they mentioned example eight, but if you look at that decision on, it's on page 1304 near the bottom, the court said, though example eight refers to extracting reduced Q10, the specifications how to, though example eight refers to extracting reduced Q10,

[00:39:29] Speaker 04:
The specification describes how to similarly extract oxidized Q10.

[00:39:33] Speaker 04:
They made the difference.

[00:39:34] Speaker 04:
They noticed the difference.

[00:39:36] Speaker 04:
Okay, we thank you, Mr. Norr.

[00:39:38] Speaker 05:
Thank you for your argument.