[00:00:00] Speaker 02:
This case is 22-1732, Tamrani versus Hamilton Technologies.

[00:00:08] Speaker 02:
Counselor Kendrick, you've asked for seven minutes for rebuttal.

[00:00:13] Speaker 02:
Is that correct?

[00:00:16] Speaker 03:
We're ready when you are, sir.

[00:00:18] Speaker 03:
Good morning, Your Honors.

[00:00:19] Speaker 03:
May it please the Court.

[00:00:21] Speaker 03:
My name is Mark Robert Kendrick, and I am representing Dr. Fleur Tamrani in this case, 22-1732.

[00:00:27] Speaker 03:
At issue in this appeal are claims 1 through 6, 9 through 12, 29 through 33, and 41 of US patents, 7, 802, 571.

[00:00:35] Speaker 03:
Claims 1 and 29 are independent claims, and the other claims at issue are dependent claims.

[00:00:40] Speaker 03:
The patent covers the first fully automatic oxygenization and ventilation system.

[00:00:46] Speaker 03:
The oxygenization parameters, fraction of inspired oxygen, FiO2, and the end expiratory pressure, PEEP, are determined automatically every fraction of a second.

[00:00:56] Speaker 03:
For example, every 0.75 seconds, as shown in figure 3i of the patent, step 318 in appendix 85.

[00:01:03] Speaker 03:
We're next.

[00:01:04] Speaker 01:
Mr. Kendrick, I think we're familiar with the technology from the briefing and the record.

[00:01:09] Speaker 01:
You raise 10 or 12 issues by my count.

[00:01:13] Speaker 01:
It's a lot of issues.

[00:01:14] Speaker 01:
What do you think is your strongest issue?

[00:01:17] Speaker 03:
The strongest issue is that the prior art documents that recited against us, the court earned in determining that they presented true information as well as that they could be combined with the other reference, the second reference.

[00:01:34] Speaker 01:
On the true information, I saw there was an attack on

[00:01:38] Speaker 01:
the accuracy of certain of the prior heart references.

[00:01:41] Speaker 01:
Is that what you're referring to?

[00:01:43] Speaker 03:
Yes.

[00:01:44] Speaker 01:
Isn't that inherently a fact question and wasn't there substantial evidence for the board to find that the references actually were reporting true information?

[00:01:54] Speaker 03:
No, we don't believe there was substantial evidence for the board to find that because if you look at the testimonies of Dr. Tehrani versus their testimonies, we don't believe there was substantial evidence.

[00:02:06] Speaker 01:
But I mean that just sounds inherently like something that is for the board to make fact findings on and they believed, you know, something different than you wanted them to believe.

[00:02:19] Speaker 01:
Isn't that what the board's there for?

[00:02:22] Speaker 03:
The board is there for that but we don't believe that they consider our arguments

[00:02:28] Speaker 03:
thoroughly enough, and didn't understand potentially the technology at issue as much as they should have been.

[00:02:35] Speaker 02:
This is perhaps a good point for me to make the following comment, which I wanted to address before you started your argument.

[00:02:43] Speaker 02:
In your brief, you used terms like baseless schemes that are made up by the board, a double standard in fallacy.

[00:02:52] Speaker 02:
implemented by the board to keep the petition exhibits, et cetera.

[00:02:57] Speaker 02:
And this tone that you have runs throughout your brief.

[00:03:02] Speaker 02:
And I just want you to know, I find it to be disrespectful, discourteous, and not beneficial.

[00:03:10] Speaker 02:
It doesn't help the case at all.

[00:03:12] Speaker 02:
to attack with labels the other side, especially the board and the decision.

[00:03:20] Speaker 02:
Now, the decision may be wrong.

[00:03:22] Speaker 02:
It may be without

[00:03:25] Speaker 02:
a basis or something of that nature, but the personal attacks is something that there's just simply no room for, not only in this column, but in this profession.

[00:03:35] Speaker 02:
Understood.

[00:03:36] Speaker 00:
I understand, Your Honor, and I take that under... Do you want to talk about specifics, for example?

[00:03:41] Speaker 00:
You said that you think one of your strongest issues is that you think the board

[00:03:47] Speaker 00:
Wasn't substantial evidence support the board's finding that the prior art taught what it purported to teach?

[00:03:52] Speaker 00:
Do you want to say specifically why?

[00:03:54] Speaker 00:
Are you prepared to identify specific testimony today?

[00:03:57] Speaker 00:
Because that's, you know, if you're talking about lack of substantial evidence, you need to have specific sites and directives to specific evidence.

[00:04:07] Speaker 00:
I mean, it's not going to be enough just to cite to the evidence that supports you.

[00:04:11] Speaker 00:
You need to explain why the evidence that's contrary to your position should be disregarded.

[00:04:16] Speaker 03:
Understood and I will attempt to do that as much as possible What when we look at the evidence that we feel was not considered by the board first we can start with Carmichael and Carmichael is a survey that is Prepared it was number of physicians.

[00:04:37] Speaker 03:
They took it.

[00:04:38] Speaker 03:
They mailed in the survey and they talked about different

[00:04:40] Speaker 03:
peep and FiO2 that they could use for automated ventilators and most of those physicians, I'm sorry, most of those physicians or doctors utilized, excuse me.

[00:04:57] Speaker 00:
We're familiar with the prior art so we have it all in front of us so if you want to get into specifically what Carmichael lacks.

[00:05:05] Speaker 03:
Okay, so what Carmichael lacks is Carmichael doesn't

[00:05:09] Speaker 03:
talk about that you can determine a FIO2 or PEEP for a next breath.

[00:05:19] Speaker 03:
It doesn't talk about that in any way, shape, or form.

[00:05:21] Speaker 03:
It's talking about an assist control ventilator.

[00:05:24] Speaker 03:
Assist control ventilator, in those what you do is you set the PEEP and you set the FIO2 initially and then you let it run and then

[00:05:35] Speaker 03:
Basically, you'll go in back and, based upon the results later, from 15 minutes to two hours in time, you will then change those settings to see if you can improve the oxygenization parameters for the ventilator.

[00:05:49] Speaker 00:
So it's a manual setting of those two parameters.

[00:05:52] Speaker 03:
Yes.

[00:05:52] Speaker 03:
Yes.

[00:05:52] Speaker 03:
That's what it assists control.

[00:05:54] Speaker 03:
It also, when you look at Carmichael, the one thing it talks about is it doesn't talk about keeping a ratio

[00:06:02] Speaker 03:
of PEEP to FIO2 within a specific range.

[00:06:06] Speaker 03:
The argument that is made, and if you look at figure seven of Carmichael, the argument is made that, oh, if you look at the highest PEEP versus the FIO2, that is where you can determine what the ratio is.

[00:06:22] Speaker 03:
But if you look at that, you basically are looking at a figure seven is a chart that shows, and I want to make sure I say it correctly,

[00:06:32] Speaker 03:
It shows multiple values that can be utilized for each of the values of FIO2, multiple P values.

[00:06:42] Speaker 03:
And it even talks about the fact that the typical best PEEP, which I believe is what the appellee mentioned before, was, for example, for 0.5 was 11 plus or minus 5 centimeters of H2O for PEEP, right?

[00:06:59] Speaker 03:
So it's not really talking about a specific specified range.

[00:07:03] Speaker 03:
It's talking about a number of range.

[00:07:04] Speaker 03:
For example, for 0.5, you could have multiple ratios, 11 over 0.5, 9 over 0.5, 7 over 0.5, or 6 over 0.5.

[00:07:14] Speaker 03:
So that's why we don't believe that Carmichael teaches that part of the invention.

[00:07:21] Speaker 03:
In addition, we don't believe, and this is overall with all of our arguments, we don't believe that you can take

[00:07:28] Speaker 03:
Protocols like it's what that's what they're referring to here We're detecting about different pairs of the peep and FiO2 that you can do that And you can put that into an automated system an automated ventilator because they just don't operate that way And specifically that would bring me over to Anderson Anderson is And really the key There's figure two in Anderson, and then there's also figure

[00:07:58] Speaker 03:
and Anderson.

[00:08:00] Speaker 03:
Figure 2 talks about the actual system construction of Anderson.

[00:08:07] Speaker 03:
We believe figure 2 of Anderson is wrong because of the fact that you can't have a PID control

[00:08:29] Speaker 03:
that's also utilizing a lookup table as part of the system.

[00:08:33] Speaker 03:
Because PID control is a negative feedback system.

[00:08:38] Speaker 03:
And a negative feedback system requires complete control, meaning complete negative control.

[00:08:47] Speaker 03:
And what you're not doing there, you can't, for every breath of the patient, go up to the lookup table.

[00:08:52] Speaker 03:
And the lookup table is shown in, like, figure three.

[00:08:55] Speaker 03:
and determine whether or not to turn on or off PEEP or FIO2, okay?

[00:09:01] Speaker 01:
And then also you can... About Dr. Imbruce, that was their expert that you challenged, correct?

[00:09:07] Speaker 01:
Yes, yeah.

[00:09:09] Speaker 01:
You argue, I think, that he was not a person of skill in the art, but you did not provide a definition of person of skill in the art.

[00:09:15] Speaker 01:
You agreed to their definition, is that right?

[00:09:18] Speaker 03:
We agreed to their definition, but their definition was... I'm sorry.

[00:09:21] Speaker 01:
And so which part of their definition

[00:09:24] Speaker 01:
Does Dr. Imbruss not meet?

[00:09:26] Speaker 03:
Any of them, because he's not, I believe there was an engineer, two different engineer of skill in the art or an engineer with a master's degree or a clinician.

[00:09:36] Speaker 00:
We don't believe that- You don't think he's a clinician?

[00:09:40] Speaker 01:
No.

[00:09:40] Speaker 01:
But he was a clinician some time ago, but he was a clinician, correct?

[00:09:44] Speaker 03:
He was a clinician 40 years ago, but things have changed in the last 40 years.

[00:09:48] Speaker 01:
Does the definition of a person of skill in the art say they have to be a clinician?

[00:09:53] Speaker 01:
more recently than 40 years ago?

[00:09:55] Speaker 03:
Well, I think they have to understand the, you know, we don't believe he had the knowledge regarding automated ventilators that he needed.

[00:10:05] Speaker 01:
But what makes him not within the definition of person, skill, and the art?

[00:10:09] Speaker 01:
Is it the lack of an engineering degree or is it that he's not a clinician or both?

[00:10:15] Speaker 03:
Well, it's lack of an engineering degree but also

[00:10:18] Speaker 03:
We don't believe his clinician, because he hasn't been a clinician in 40 years.

[00:10:22] Speaker 03:
He didn't renew his respiratory therapist certificate.

[00:10:26] Speaker 03:
And he doesn't really have the experience on these ventilators he need to have in order to make his declaration.

[00:10:35] Speaker 00:
Did the board find that he was a person of ordinary scale near?

[00:10:39] Speaker 03:
The board did find that, I believe.

[00:10:44] Speaker 03:
Yes.

[00:10:45] Speaker 03:
He was a clinician.

[00:10:47] Speaker 03:
In your view, is that a factual finding?

[00:10:51] Speaker 03:
In your view.

[00:10:53] Speaker 03:
I'm not the most experienced in front of this court.

[00:10:55] Speaker 03:
I'll tell you that.

[00:10:57] Speaker 03:
It's a factual.

[00:10:58] Speaker 03:
I believe they made a factual determination, but I believe it was an error that they made that.

[00:11:07] Speaker 03:
The other.

[00:11:07] Speaker 00:
I couldn't hear you.

[00:11:09] Speaker 00:
They made a factual finding that what?

[00:11:10] Speaker 00:
Could you repeat that?

[00:11:11] Speaker 03:
Oh, and I've said it was just an error, that the factual

[00:11:15] Speaker 03:
determination they made was an error, that it was incorrect.

[00:11:20] Speaker 03:
In addition, and again, should I keep going?

[00:11:27] Speaker 03:
Have I gone over my time?

[00:11:29] Speaker 02:
Very, very good.

[00:11:31] Speaker 02:
Yeah, you still have a little bit of rebuttal time.

[00:11:33] Speaker 02:
You're into your rebuttal time.

[00:11:34] Speaker 02:
You want to finish now, or?

[00:11:37] Speaker 03:
I'll talk a little bit about Anderson, and then I'll finish.

[00:11:39] Speaker 02:
OK.

[00:11:40] Speaker 03:
Figure 7 of Anderson is also really dispositive.

[00:11:44] Speaker 03:
Figure 7 shows that PEEP was not changed for 12 hours.

[00:11:49] Speaker 03:
It also shows that FIO2, if you look at FIO2, it starts out at 45, goes to 80, comes back down to, I say 45, but it's between 45 and 50.

[00:12:01] Speaker 03:
And that shows again that the ratio wasn't maintained.

[00:12:06] Speaker 03:
There was no ratio maintained because PEEP was going up and down, I'm sorry, FIO2 was going up and down like that and PEEP was staying the same.

[00:12:13] Speaker 03:
You also, if you look

[00:12:14] Speaker 03:
at PEEP, if there was PID control at PEEP, like has been alleged at Anderson, then it would never stay the same for that long.

[00:12:24] Speaker 03:
It wouldn't stay the same for minutes at a time, right?

[00:12:28] Speaker 03:
Because that's just the way it is.

[00:12:29] Speaker 03:
But it would not stay for 12 hours, which is what it said.

[00:12:33] Speaker 03:
And even when it is changed, it's changed in a way where it's stepped up.

[00:12:38] Speaker 03:
And that clearly to us shows that it's a manual adjustment.

[00:12:42] Speaker 03:
because it's not something that was ramped up, it was something that was stepped up.

[00:13:12] Speaker 04:
May it please the court, Patrick Teene and co-counsel Matthew Fedowitz on behalf of the appellee Hamilton.

[00:13:19] Speaker 04:
I have three quick points I'd like to make, and then I will offer some comments in response to those of my friend on behalf of the appellant.

[00:13:28] Speaker 04:
The three points I'd like to begin with are that there is substantial evidence for all of the board's factual findings detailed throughout the final written decision, which is at 1 to 69 of the appendix.

[00:13:40] Speaker 04:
There was no error of law.

[00:13:43] Speaker 04:
to the extent an error of law is implicated.

[00:13:46] Speaker 04:
It's based on factual underpinnings, which are supported by substantial evidence.

[00:13:50] Speaker 04:
And finally, the board acted fully appropriately in the implementation and management of all of its rules.

[00:13:58] Speaker 04:
With those three points, the final written decision should be affirmed.

[00:14:02] Speaker 04:
And now I'd like to offer a few comments on some of the points that my friend addressed there.

[00:14:09] Speaker 04:
They are all factual issues.

[00:14:12] Speaker 04:
as Your Honors seem to appreciate.

[00:14:15] Speaker 04:
The Carmichael reference, which was referred to, was the base reference used in a ground that was initially an anticipation ground that involved what were in fact automated ventilators.

[00:14:26] Speaker 04:
The ventilators have a computer in them.

[00:14:27] Speaker 00:
Can you explain why Figure 7 shows ratios?

[00:14:31] Speaker 00:
I think I understand why it is, but could you explain it?

[00:14:34] Speaker 04:
Yes, certainly, Your Honor.

[00:14:35] Speaker 04:
Figure 7 is showing the

[00:14:38] Speaker 04:
the limits on the oxygen, the FiO2, and the pressure, the positive and expiratory pressure.

[00:14:46] Speaker 04:
And the ratios are the slope basically of that curve.

[00:14:50] Speaker 04:
And what the patent claim is directed to is managing an automated ventilator

[00:14:54] Speaker 04:
so that for patient safety, you don't exceed certain limits of PEEP and FIO2.

[00:14:58] Speaker 04:
That's what the PEEP ratio is.

[00:14:59] Speaker 00:
Is the idea that when you look at figure seven, and you see there's a certain PEEP for a certain FIO2, like ranges, if you will, that that's what the ratios are, that that inherently shows for a certain PEEP, you'd have a certain FIO2, which itself is a ratio?

[00:15:15] Speaker 00:
Is that how it works in that, or am I simplifying it?

[00:15:19] Speaker 00:
I'm sorry.

[00:15:19] Speaker 00:
I'm just talking about the prior art.

[00:15:20] Speaker 00:
Not the claim, but Carmichael, what Carmichael teaches.

[00:15:24] Speaker 04:
What Carmichael shows is a boundary, a limit on what the PEEP can be, as you're indicating, and a boundary on what the FiO2 can be.

[00:15:32] Speaker 04:
So for patient safety, neither of those ranges can be exceeded.

[00:15:37] Speaker 04:
So for a certain FiO2, PEEP can only be so high.

[00:15:40] Speaker 04:
For another FiO2, PEEP can only be so high.

[00:15:43] Speaker 04:
So PEEP is restricted to something like 0.6 millimeters of hemoglobin, I think was the

[00:15:50] Speaker 04:
was the number, I don't have it right in front of me, but PEEP is limited, and so, and PEEP's the pressure.

[00:15:54] Speaker 04:
You can't allow that pressure to exceed certain limits where you could damage a patient's lungs.

[00:15:59] Speaker 04:
So what the chart is showing is that we're going to allow therapy to continue until PEEP is at a certain limit, and if we're not achieving a desired level of therapy, we're going to adjust the amount of oxygen, and then incrementally move the pressure to push that oxygen into the patient.

[00:16:14] Speaker 04:
But nevertheless, we're going to observe limits, and the limits are

[00:16:18] Speaker 04:
relative to PEEP and the FiO2 limits are demonstrated by the slope of that curve.

[00:16:22] Speaker 04:
Thank you.

[00:16:23] Speaker 01:
The appellant says there's no reference to automatic in Carmichael.

[00:16:29] Speaker 01:
Is that true?

[00:16:29] Speaker 01:
And is that a problem for your obviousness contention?

[00:16:32] Speaker 04:
It's not a problem.

[00:16:34] Speaker 04:
What is mentioned, I think what my friend's definition of automatic is something like a fully automatic.

[00:16:39] Speaker 04:
And what Carmichael was using were automated ventilators that had computers in them.

[00:16:46] Speaker 04:
to perform this assist control, whereas, I think your honor's noted, you could set an adjustment, you could set an FiO2 or a PEEP, and then the automated ventilator would, with a computer, perform to that set level.

[00:17:00] Speaker 04:
So there was automation, and there was automation.

[00:17:04] Speaker 04:
Carmichael was being used at the time to develop

[00:17:09] Speaker 04:
what would be appropriate limits for PEEP and FIO2.

[00:17:12] Speaker 04:
And so it was using existing ventilators.

[00:17:14] Speaker 04:
And some of those existing ventilators were in the prior arc that we relied upon, such as in our earlier grounds, the WASL patent was an existing fully automated ventilator that most likely was used by Carmichael, by the clinicians in Carmichael to run those tests.

[00:17:29] Speaker 04:
But it just didn't say it.

[00:17:31] Speaker 04:
And the board said, we want to see the actual structural characteristics of a ventilator in a reference.

[00:17:36] Speaker 04:
And that's where we brought in our grounds three and four, that with substantial evidence, the board said, yes, we see the application of an automated ventilator using these clinically derived limits for PEEP and FiO2 and simply programming the automated ventilators of an Anderson in ground three or a Taub in ground four.

[00:17:56] Speaker 04:
to provide patient therapy around the limits of PEEP and FiO2 that are announced in Carmichael.

[00:18:04] Speaker 04:
My friend did mention Anderson presented untrue data and that you couldn't use a lookup table with PID control, PID being proportional integral derivative control.

[00:18:16] Speaker 04:
Of course, that was fully vetted before the board and the board found substantial evidence

[00:18:21] Speaker 04:
to support its finding that, in fact, PID could be used with a lookup table in exactly similar fashion as to what the patent disclosed using loop indicators to set different types of therapy.

[00:18:36] Speaker 04:
So it's not a question of going back and forth to a lookup table every breath.

[00:18:39] Speaker 04:
At every breath, the computer can look at what the parameters are, the settings for the PEEP and the FAF2, and it can see if they're within the limits of what the lookup table says they should be.

[00:18:49] Speaker 04:
But the actual continuous control is through the PID controller to the ventilator.

[00:18:55] Speaker 04:
So the board found that lookup tables could be used with PID control.

[00:19:03] Speaker 04:
The third point I would address is, and Judge Stark mentioned, the qualifications of Dr. Imbruss as a Posita.

[00:19:09] Speaker 04:
And the board did find that, that Dr. Imbruss had been a practicing clinician at the time, at the relevant time, that this

[00:19:19] Speaker 04:
patent was developed.

[00:19:20] Speaker 00:
Do you think that the board, we have some case law like Kyocera, for example, or Sundance that says that for somebody to testify on an issue that is viewed from the perspective of a person of ordinary skill in the art, like say, obviousness, that they have to actually be a person of ordinary skill in the art.

[00:19:40] Speaker 00:
Do you think the board followed that case law?

[00:19:43] Speaker 04:
I mean, absolutely.

[00:19:43] Speaker 04:
I would say that the board vetted Dr. Invers's credentials.

[00:19:47] Speaker 04:
as a clinician who had experience in developing, designing, producing.

[00:19:51] Speaker 04:
I believe he was involved in the development of a major ventilator for a well-known international company.

[00:19:56] Speaker 04:
So he had experience in the design of ventilators and in the application of therapy to those, such as PEEP and FIO2 limits.

[00:20:03] Speaker 04:
So certainly his clinical experience in the relevant time period, when he was familiar with the ventilators, the automated ventilators that existed at the time, such as Andersen's and Tau, qualified him as a Bozita.

[00:20:18] Speaker 04:
Does that?

[00:20:19] Speaker 00:
It does.

[00:20:22] Speaker 00:
The board never says he is a person of ordinary scale in New York.

[00:20:28] Speaker 00:
So should I be concerned about that?

[00:20:30] Speaker 00:
I mean, you can look at where it never uses that exact crazyology.

[00:20:36] Speaker 00:
The question would be whether they, in fact, said he was a person of ordinary skill in the art by going through the definition of a person of ordinary skill in the art.

[00:20:46] Speaker 04:
I believe that, and we can check the final written decision, but I was confident that the board did say we consider him to be a person of skill in the art, and we don't accept

[00:20:59] Speaker 04:
my friend's assertions at the time during the process of the IPR that Dr. Imbruce did not so qualify.

[00:21:07] Speaker 04:
And I would add also that because of the accusations that were made on the Anderson paper, we went out and questioned Dr. Anderson and actually brought him in as a witness to substantiate things that Dr. Imbruce was saying about the application of therapy treatment, FiO2 and PEEP ratios to automated ventilators, and Dr. Anderson

[00:21:30] Speaker 04:
supported Dr. Andrews, and Dr. Andrews supported Dr. Anderson.

[00:21:32] Speaker 04:
So we had countervailing declarations to support that what Dr. Andrews was saying was, in fact, true and accurate.

[00:21:40] Speaker 02:
Was the issue of a person splitting the art, was that actually in dispute below?

[00:21:47] Speaker 04:
I think what was in dispute was the accuracy of statements made by Dr. Andrews, to which one way we addressed that was to have Dr. Anderson testify.

[00:21:59] Speaker 04:
and the support of those two declarations in tandem, I think the board found compelling.

[00:22:05] Speaker 04:
But there was no reason really to question Dr. Ambrose's qualifications because he squarely met the first prong of the posita as was defined and agreed upon by the parties, which was someone who had at least five years of experience in clinical therapy with ventilators.

[00:22:21] Speaker 04:
And he not only had that, he had something like 10 years

[00:22:24] Speaker 04:
and he had been involved in the design.

[00:22:26] Speaker 04:
And he had patents, so he was familiar with the patent process and so forth.

[00:22:29] Speaker 04:
So he was more than qualified, I would say.

[00:22:33] Speaker 01:
But whether he was a person of skill in the art, I think was put in dispute.

[00:22:39] Speaker 01:
And like Judge Dole, I'm not seeing where the board made an express finding that he was one of skill in the art, notwithstanding both counsel telling us that there was such a finding.

[00:22:48] Speaker 01:
I haven't found it yet.

[00:22:50] Speaker 01:
If that's how we see the record,

[00:22:53] Speaker 01:
Is that a harmless error or what do we do?

[00:22:56] Speaker 01:
That is, if we say there was a dispute over whether Dr. Imbruce was a person of skill in the art and the board didn't make an express finding on it, what do we do?

[00:23:04] Speaker 04:
Well, I think that the board found on its own that the references taught the invention as claimed.

[00:23:13] Speaker 04:
And I think that they felt very compelling evidence was

[00:23:21] Speaker 04:
What the board found very compelling was Dr. Anderson's testimony about his ventilator.

[00:23:28] Speaker 04:
And I would add that Dr. Anderson's testimony did go to the application of the limits that were described in the Carmichael reference to the ventilator that Anderson was actually running in a fully automated continuous ventilator therapy mode.

[00:23:44] Speaker 04:
For example, the lookup tables that were in, I'm sorry,

[00:23:47] Speaker 04:
I think it was to look at.

[00:23:48] Speaker 04:
There was a figure in Anderson, and I don't have it right in front of me, where he does show that you could choose different treatment therapies.

[00:23:56] Speaker 04:
And he talked about boundaries that aligned with those of Carmichael.

[00:24:02] Speaker 04:
So I would say to that extent, it is harmless.

[00:24:06] Speaker 04:
But I do also think that the board repeatedly recognized the weight that it would attribute to Dr. Ingers's testimony.

[00:24:14] Speaker 04:
And that appears in their final written decision

[00:24:17] Speaker 04:
at Appendix 13 where they talked about the way to give Dr. Imbrice's testimony and concluded that we do not agree with Pat and owner that Dr. Imbrice's testimony should be disregarded.

[00:24:28] Speaker 04:
And so if not nearly expressed, that's a very implicit statement that we consider his testimony, the veracity of his testimony to be high and reliable in terms of comments he made with regard to the grounds that were used for supporting

[00:24:45] Speaker 04:
a finding that the challenge funds were not patentable.

[00:24:53] Speaker 04:
So the last point I would like to address is the response, again, to Dr. Anderson's Figure 7.

[00:24:59] Speaker 04:
And there was a comment in there about how it must be manual.

[00:25:02] Speaker 04:
But again, the board evaluated Dr. Anderson's disclosures in light of Dr. Anderson's testimony, found it to be accurate,

[00:25:13] Speaker 04:
reliable and therefore the interpretations that the board relied upon in its findings and the substantial evidence that it attributed in the form of Dr. Anderson's declaration were compelling for its conclusion that both grounds, well, ground three involving Dr. Anderson's paper rendered the claims unpandable.

[00:25:34] Speaker 04:
And with that, I have nothing more to say.

[00:25:38] Speaker 04:
If you have any other questions, happy to answer.

[00:25:41] Speaker 02:
Thank you, Attorney King for your... Thank you, Your Honor.

[00:25:48] Speaker 02:
Mr. Kendrick, I'm going to restore you to three minutes of time since you called.

[00:25:53] Speaker 02:
I do caution you to limit your comments to the points raised by the other side.

[00:26:01] Speaker 03:
Absolutely.

[00:26:02] Speaker 03:
In regards to

[00:26:04] Speaker 03:
the accuracy of Dr. Ambrose's testimony and the weight that was poured to it.

[00:26:10] Speaker 03:
I mean, one of the things that we also looked at was what he didn't disclose certain things in the CV that I've seen before in the CV, like whether or not he had been an expert before, which he had.

[00:26:20] Speaker 03:
And then during deposition, he talked about that he worked on Siemens ventilators, automated ventilators.

[00:26:27] Speaker 03:
That wasn't in his CB also.

[00:26:30] Speaker 03:
So that was one of the other things why we believe that Dr. Keirani is, um, that her testimony should be giving more weight than what... It's hard for us at an impelled court to decide how much weight to give to different witnesses testimony, right?

[00:26:48] Speaker 00:
That's really something for the trial court, the lower court to decide.

[00:26:54] Speaker 00:
Why would we be deciding?

[00:26:57] Speaker 03:
I just think they made an error when they made that determination.

[00:27:01] Speaker 03:
They didn't look at all the facts.

[00:27:04] Speaker 03:
With regard to Dr. Anderson, yes, he is a doctor.

[00:27:07] Speaker 03:
He's a doctor in regards to engineering.

[00:27:11] Speaker 03:
He's not necessarily a clinician who worked on the Anderson.

[00:27:14] Speaker 03:
We believe that also there are certain things that, you know, one of the things is when you have a device that's being utilized on patients and it's automatic, you do have to get FDA approval.

[00:27:27] Speaker 03:
And while he said he thought they had FDA approval, there was no affirmative or definitive statement that it was on, excuse me, that there was FDA approval with regards to that.

[00:27:40] Speaker 03:
We also just don't believe he has the background

[00:27:43] Speaker 03:
in terms of automated ventilators that he would need to have in order to provide such a statement.

[00:27:50] Speaker 00:
One of the things that you see in the uncontested definition of what a person with ordinary skill in the art is, there's a sentence at the end that says, a higher level of education or specific skill might compensate for less experience and vice versa.

[00:28:05] Speaker 00:
How does that play into it?

[00:28:07] Speaker 00:
Doesn't that give a little bit of wiggle room, at least, with respect to whether he was a clinician with at least five years of practical clinical ventilator experience, for example?

[00:28:19] Speaker 03:
Is this for Dr. Anderson or Dr. Improus?

[00:28:22] Speaker 00:
For the expert on which you are challenging whether he was a person of ordinary skill.

[00:28:27] Speaker 03:
Oh, for Dr. Improus, yes.

[00:28:29] Speaker 03:
Yeah.

[00:28:30] Speaker 03:
I just don't believe his education applies over to the technology that we're looking at, the automated ventilators for an expert of the patient.

[00:28:41] Speaker 03:
So that's why it's my opinion that his testimony shouldn't be heard.

[00:28:47] Speaker 03:
The last thing I did want to make, there was not a discussion of any ventilators in Carmichael.

[00:28:53] Speaker 03:
So to make a statement like that these other ventilators that existed at the time that they were utilized in Carmichael, that's just, we don't believe an accurate statement.

[00:29:01] Speaker 03:
And really overall, the prior art doesn't show that PEEP and FIO2 are controlled for next breath, automatically controlled for next breath.

[00:29:10] Speaker 03:
So based upon that, we would ask the court to reverse the board's decision.

[00:29:17] Speaker 03:
We respectfully request the court to reverse the board's decision.

[00:29:21] Speaker 03:
Thank you.

[00:29:22] Speaker 03:
Thank you.

[00:29:23] Speaker 02:
We thank the parties for their arguments.

[00:29:26] Speaker 02:
This case will be taken under advisement.