[00:00:34] Speaker 04:
The next case for argument this morning is 14-1713, University of Manitoba versus Draper Medical.

[00:00:42] Speaker 04:
Give everybody enough of a chance to get settled.

[00:01:27] Speaker 02:
The inventors of the 350 patent discovered that the provision to a surgical patient of biological fluids in a form that is monotonous both in terms of rate and periodicity is detrimental to the patient's health, or can be, because that does not emulate the way patients normally function.

[00:01:51] Speaker 02:
Therefore, as their discovery, they introduced variability into the provision of these surgical fluids

[00:01:58] Speaker 02:
in order to make sure that there was an emulation of the way that the patients normally function.

[00:02:03] Speaker 00:
Can I ask this question and maybe more of a medical question than a patent question?

[00:02:11] Speaker 00:
If the object of this fluid delivery system is to produce

[00:02:19] Speaker 00:
something like to emulate, as you say, what a patient not needing aid would be getting.

[00:02:29] Speaker 00:
How is it possible for the delivery not to take into account

[00:02:39] Speaker 00:
patient efforts so that your view is that the claim is to be construed so that the delivery of the fluid is patient independent, same volume and rate of fluid delivery, whether or not the patient is endogenously contributing some of

[00:03:08] Speaker 00:
the fluid delivery.

[00:03:11] Speaker 00:
Isn't the net effect of that not to emulate, but in fact to depart from what would be happening in a healthy patient?

[00:03:21] Speaker 02:
Actually, Your Honor, that isn't our position at all.

[00:03:24] Speaker 02:
We're saying there are two circumstances that can be involved, one in which a patient isn't breathing at all, which is clearly covered by the claims, and one in which the patient does contribute breathing.

[00:03:33] Speaker 02:
So the device has to take into account whether there is patient breathing or not,

[00:03:38] Speaker 02:
And the variability is intended to provide a variability to whatever gas or fluid is provided to the patient.

[00:03:46] Speaker 02:
So if the patient is breathing somewhat, the variability will take into account that fact and will not provide the patient more oxygen or blood than the patient can possibly handle.

[00:03:58] Speaker 02:
And if the patient isn't breathing at all or isn't supplying any of the blood,

[00:04:02] Speaker 02:
then that variability will be introduced to the provision of the 100% of whatever the oxygen or blood is that's being provided to the patient.

[00:04:11] Speaker 01:
What's the purpose of the limitation then?

[00:04:13] Speaker 01:
I'm confused.

[00:04:14] Speaker 01:
I assumed that you would maintain the same variable flow irrespective of whether the patient was breathing or not.

[00:04:23] Speaker 02:
No, the variability, so if we look at a sinusoidal waveform, the periodicity and volume will vary whether or not the patient is contributing.

[00:04:31] Speaker 02:
In other words, you do not want a monotonous wave form.

[00:04:35] Speaker 02:
So if the patient is providing this much of the effort in one cycle, the added gas may be some discrete amount.

[00:04:44] Speaker 01:
That's what I thought.

[00:04:45] Speaker 01:
I just want to make sure I'm understanding.

[00:04:46] Speaker 01:
So if there was no patient effort, I'm just going to use a really ridiculously simple example.

[00:04:53] Speaker 01:
If there was no patient effort, you'd be having a wave going up and down with

[00:04:58] Speaker 01:
10 marks on a graph.

[00:05:01] Speaker 01:
If the patient was breathing, you might go up 11 or 12.

[00:05:07] Speaker 01:
Am I understanding this correctly?

[00:05:08] Speaker 01:
In other words, that you'd have a combination of the flow coming from the device and the flow coming from the patient?

[00:05:16] Speaker 02:
That would vary if we look at the peaks of each waveform.

[00:05:20] Speaker 02:
the peaks will be different.

[00:05:21] Speaker 02:
That's where the variability will come in, as will the periodicity of the wave.

[00:05:24] Speaker 01:
It doesn't adjust itself to take into account what the patient is doing.

[00:05:31] Speaker 01:
The flow is the same regardless of whether the patient is breathing or not.

[00:05:35] Speaker 01:
The peaks and valleys on the graph are going to be different.

[00:05:41] Speaker 02:
If I understand the question, no, Your Honor.

[00:05:44] Speaker 02:
There will have to be some account taken because obviously a machine cannot vary

[00:05:48] Speaker 02:
to an extent that a patient is given more air than his lungs can hold.

[00:05:51] Speaker 01:
Well, but that's where I'm confused, though, because I thought the limitation is that there's no patient effort.

[00:05:58] Speaker 01:
In other words, isn't that what you disclaimed?

[00:06:01] Speaker 01:
Is your flow going to be the same whether the patient makes an effort or not?

[00:06:06] Speaker 02:
No.

[00:06:07] Speaker 02:
What we're saying, Your Honor, and I'll get into this when I talk about the prosecution history, but the purpose of the distinction over the prior art

[00:06:14] Speaker 02:
was that the prior art said, well, if a patient is providing this much effort, we are going to add an additional increment to ensure that every single time you have a target volume provided to the patient.

[00:06:25] Speaker 02:
In other words, the provision of the volume is monotonous.

[00:06:29] Speaker 02:
The patient will get the same amount of oxygen every single time.

[00:06:33] Speaker 00:
That's where the monotony comes in.

[00:06:36] Speaker 00:
should be the same.

[00:06:38] Speaker 00:
That's what the prior art said.

[00:06:39] Speaker 00:
And it can come from two things, at least, your machine and the patient.

[00:06:44] Speaker 00:
That's certainly what the prior art said, that the volume... I think we're all talking about the same confusion, or at least it's my confusion.

[00:06:54] Speaker 00:
In the prosecution history, you've distinguished... StatWiki, is it?

[00:07:00] Speaker 02:
StatWiki, yes.

[00:07:02] Speaker 00:
On the ground that

[00:07:05] Speaker 00:
That system varied the exogenous contribution, the machine contribution, according to whether the patient was providing some contribution of his own, and yours doesn't.

[00:07:18] Speaker 00:
Yours provides the same machine supplied contribution based on a predetermined pattern from studies of animals or whatever, and that the machine does the same thing regardless of what the patient is doing.

[00:07:35] Speaker 00:
Is that not right?

[00:07:36] Speaker 02:
That was not what the prosecution history said, Your Honor.

[00:07:39] Speaker 02:
If we actually look at, it's actually replicated at page 817 of the opinion.

[00:07:44] Speaker 02:
Right, I'm looking at it.

[00:07:45] Speaker 02:
And it says a couple of things.

[00:07:47] Speaker 02:
The first part is the Stowicki reference is concerned primarily with the weaning type of ventilator wherein gas flow to the patient is controlled in accordance with a pressure volume control law to ensure the delivery of a target volume to the weaning patient while taking into account patient effort.

[00:08:04] Speaker 02:
What this is saying is that we have a monotonous provision of this target volume, albeit in conjunction with whatever the patient is contributing.

[00:08:15] Speaker 02:
And then it says in the absence of patient effort, so we go on to talk about what happens under Stoicke if there is no patient effort, the system described by Stoicke will deliver a monotonously regular tidal volume and respiratory rate according to the preset values programmed by the operator.

[00:08:31] Speaker 02:
So whether the patient is breathing or not under StoWitki, you have this monotonous provision of surgical fluids.

[00:08:38] Speaker 02:
That's what's being distinguished in the 350 patent, not whether the patient is breathing or not.

[00:08:46] Speaker 00:
I must say, I read this to be something like the opposite of what you just described, that your distinction of StoWitki was that it adjusts the amount coming out of the machine

[00:09:00] Speaker 00:
to take into account whether the patient is delivering some of his own fluid.

[00:09:06] Speaker 00:
And so the machine contributes less than it would if the patient is not making a contribution.

[00:09:13] Speaker 00:
The object being that the sum of the two contributions shall be the right sum, getting the correct either sinusoidal wave, but it says to get the net receipt

[00:09:28] Speaker 00:
our machine contribution will be adjusted to take into account what the patient is doing for himself.

[00:09:36] Speaker 00:
And you're saying, we don't do that.

[00:09:39] Speaker 00:
Our machine gives the same contribution independent of anything that the patient is doing.

[00:09:50] Speaker 02:
Only in the event that the patient isn't breathing at all, Your Honor.

[00:09:53] Speaker 02:
I mean, if we have a situation where the patient is breathing,

[00:09:56] Speaker 02:
there has to be some account taken of that patient breathing effort.

[00:09:59] Speaker 01:
But how is that different from Stoecki then?

[00:10:01] Speaker 02:
Because Stoecki says that whether the patient is breathing or not, we are going to provide this monotonous sinusoidal waveform.

[00:10:08] Speaker 02:
We are going to make sure that every so often, with a regular periodicity, we are going to make sure that this patient.

[00:10:15] Speaker 04:
Well, wait a minute.

[00:10:16] Speaker 04:
It says in the middle of that first paragraph you're reading from, the Stoecki system provides for a variable degree of assistance depending on the degree of patient effort.

[00:10:25] Speaker 02:
for a target volume.

[00:10:27] Speaker 02:
i.e.

[00:10:28] Speaker 02:
you're getting a target volume that's preset by the operator to provide for the same amount of oxygen to the patient every single time.

[00:10:36] Speaker 01:
Right, and then how is this, how is the 350 patent different?

[00:10:40] Speaker 02:
Because it says at the end of the day, whether the patient is breathing or not, we are going to get a non-monotonous waveform.

[00:10:47] Speaker 02:
There will be X volume provided in one period, there will be Y volume provided in another, and Z in another.

[00:10:54] Speaker 02:
So the novelty is,

[00:10:56] Speaker 02:
correct that's exactly right your honor the whole point is this what the inventors found out was patients don't breathe with regularity both in terms of timing and volume over and over and over again so if they're undergoing a surgical procedure or what you're providing to them is surgical fluids

[00:11:17] Speaker 02:
based on the same volume every 30 seconds.

[00:11:21] Speaker 01:
Getting a little bit clearer, I guess I'm still confused because now you're saying the novelty is that it's not monotonous, and you're saying that, like Steadwicky, the patient effort doesn't matter because you're adjusting to the patient effort as it goes along.

[00:11:37] Speaker 01:
So what was the point of the limitation then about no patient effort?

[00:11:41] Speaker 01:
Why did you agree to that?

[00:11:43] Speaker 02:
We didn't, Your Honor.

[00:11:45] Speaker 02:
There is no limitation in the claim to say no patient effort.

[00:11:48] Speaker 04:
Well, except there's this piece of the prosecution history that says it quite clearly, right?

[00:11:55] Speaker 04:
In the absence of the present invention, there is no patient effort to be taken into consideration, and the variation in respiratory rate and title volume is predetermined for a patent taken.

[00:12:08] Speaker 04:
What you were arguing was the distinction between your invention and the prior art.

[00:12:13] Speaker 02:
Well, Your Honor, we believe if you read the entirety of that passage, what it's really talking about is the distinction between a monotonous provision of surgical fluids versus something that varies the provision of those fluids, whether patient breathing is involved or not.

[00:12:28] Speaker 02:
That's what the entirety of that paragraph is intended to distinguish.

[00:12:32] Speaker 02:
Because if we actually look at what was added to get around Stowicky, controlled life support conditions,

[00:12:38] Speaker 02:
What Drager would have the court believe is that that was added because no patient effort was to be taken into account.

[00:12:44] Speaker 02:
But if we look at the language, controlled life support conditions, that doesn't do the trick if that's really the distinction that the applicant was intending to interject.

[00:12:54] Speaker 02:
Because one can imagine a situation where the patient is providing 10% of the oxygen

[00:13:00] Speaker 02:
and a machine is providing the other 90%.

[00:13:03] Speaker 02:
There can't be much argument that that would be a controlled life support condition.

[00:13:06] Speaker 02:
The patient would die if the patient didn't get this 90% of the oxygen from the machine.

[00:13:12] Speaker 04:
Well, I don't think anybody's arguing, nor did the district court conclude that the language and the claims was absolutely clear and dispositive here.

[00:13:20] Speaker 04:
I mean, he relied on, he or she relied on the prosecution history disclaimer, right?

[00:13:25] Speaker 04:
that well the question is whether or not given the notice function of claims in prosecution history and we rely on this you're saying that this was misread people are taking yeah you're right one sentence may be out of context but the sentence

[00:13:42] Speaker 04:
seems quite clear.

[00:13:44] Speaker 04:
So it's just really hard to know what to make of this.

[00:13:48] Speaker 02:
Well, Your Honor, that's why this Court has admonished over and over again that we don't read sentences from the prosecution history in isolation.

[00:13:55] Speaker 02:
We have to read the entirety of the prosecution history.

[00:13:58] Speaker 02:
And we also have to read the specification.

[00:14:00] Speaker 04:
What if the specification says... Well, your position isn't that if you read the entirety, it's absolutely crystal clear what's going on here, is it?

[00:14:06] Speaker 02:
Oh, yes, it is, Your Honor.

[00:14:08] Speaker 02:
We make it very clear in the prosecution history.

[00:14:10] Speaker 02:
But the distinction in Stowicky and Bloom is that in those two references, you're talking about the monotonous provision both in terms of time and volume, surgical fluids to a patient, and that this invention varies that up to serve the needs of a patient to emulate that patient's normal bodily functions.

[00:14:32] Speaker 02:
That's the whole purpose of this invention, Your Honor.

[00:14:35] Speaker 04:
Is there anything, if the whole purpose of the invention, and it's clear, is there anything you can point us to in the specification that gives us guidance or informs us analysis?

[00:14:46] Speaker 02:
Yes, Your Honor.

[00:14:46] Speaker 02:
As a matter of fact, the district court noted on page 815, it talks about, let's see, if we look at page 879, column 1, lines 48 to 50, it talks about

[00:15:02] Speaker 02:
alterations in gas exchanges being demonstrated in healthy patients being ventilated during elective surgery.

[00:15:08] Speaker 04:
Those patients are capable of... Hold on, hold on.

[00:15:11] Speaker 02:
You're ahead of me.

[00:15:12] Speaker 02:
Okay.

[00:15:12] Speaker 02:
A79... A79, column 1, lines 48 to 50.

[00:15:15] Speaker 02:
Okay.

[00:15:16] Speaker 02:
It talks about these alterations in gas exchanges being demonstrated in, quote, healthy patients being ventilated during elective surgery.

[00:15:25] Speaker 02:
Even the district judge said it's pretty clear that some of those patients, at least, are capable of breathing on their own.

[00:15:31] Speaker 02:
Then, if we actually look at another embodiment, which appears at page 880, column 3, and this is at lines 29 through 32, it says, the principles of the invention may be used in intraaortic balloon counter pulsation, or IABC, the techniques used to support patients usually following CPB, cardio bypass surgery, when they are unable to maintain adequate cardiac output.

[00:15:57] Speaker 02:
Not no cardiac output, but adequate cardiac output.

[00:16:00] Speaker 02:
So these patients are actually able to pump some blood, just not enough.

[00:16:04] Speaker 02:
And this invention applies to providing additional blood to them.

[00:16:09] Speaker 02:
And because the claims are talking about biological fluids and not just oxygen, it would be illogical to say, well, the claims don't take into it, there can't be any patient breathing when we're talking about that aspect of biological fluids.

[00:16:21] Speaker 02:
But if we're talking about blood, the patient can have some heart activity pumping some blood.

[00:16:27] Speaker 02:
You have to construe these limitations to be the same.

[00:16:29] Speaker 02:
So whether you're talking about oxygen or whether you're talking about blood, they're both biological fluids.

[00:16:35] Speaker 02:
And the patent very specifically contemplates situations where the patient would be providing some of that.

[00:16:42] Speaker 02:
I'll reserve the rest of my time for about a minute.

[00:17:19] Speaker 03:
I'm not sure what proposed definition Palin is proposing now.

[00:17:24] Speaker 03:
He had one at the lower court hearing.

[00:17:27] Speaker 03:
He proposed one in his reply brief.

[00:17:30] Speaker 03:
I'm not sure what his current proposal is.

[00:17:33] Speaker 03:
The proposal on record was fundamentally the primarily argument.

[00:17:39] Speaker 03:
So I'm not sure, although he's trying to make some points, I'm not sure what the ultimate point is here.

[00:17:45] Speaker 04:
Well, the reason we're here, I thought, was irrespective of even if he says plain and ordinary meaning.

[00:17:54] Speaker 04:
We're not really talking about the definition of the term in the claim.

[00:17:59] Speaker 04:
We're relying on, we're almost now trying to interpret

[00:18:02] Speaker 04:
the prosecution history in this case.

[00:18:05] Speaker 04:
So why don't you tell us why his argument with regard to the prosecution history doesn't have some weight if you read the provision in its entirety?

[00:18:16] Speaker 00:
Sure.

[00:18:16] Speaker 00:
And as part of that, can you point us to where, if anywhere, in Stowicki, Stowicki shows a non-monotone waveform machine supply of fluid?

[00:18:33] Speaker 03:
Yes.

[00:18:35] Speaker 03:
But before I do that, as part of that, as a first point, let me say this.

[00:18:41] Speaker 03:
The plaintiff or appellant was arguing that this was the point of the invention.

[00:18:45] Speaker 03:
And he says a non-monotonous volume.

[00:18:48] Speaker 03:
He keeps talking about volume.

[00:18:50] Speaker 03:
He distinguishes de Wicke on the basis of it has a monotonous volume.

[00:18:56] Speaker 03:
The truth is de Wicke, if we look at de Wicke, which is 792,

[00:19:03] Speaker 03:
It is, yes.

[00:19:05] Speaker 03:
If we go to the page 802, the first page, the column one of the specification,

[00:19:32] Speaker 03:
at the bottom of the page on line 65, column 1.

[00:19:36] Speaker 03:
It says, a prime concern of any ventilator is accommodation to patient effort.

[00:19:40] Speaker 03:
And that's a ventilator that's operating, as we said, ventilators can operate under two principles.

[00:19:46] Speaker 03:
Either they accommodate patient effort, or they don't.

[00:19:49] Speaker 03:
And the programmer has to choose which software is going to run.

[00:19:52] Speaker 03:
Are we going to accommodate any patient effort, or are we not?

[00:19:58] Speaker 03:
patent was a patent defined or designed to accommodate patient effort.

[00:20:04] Speaker 03:
And it says accommodation to patient effort, now here's the term picked up by the patentee in his arguments during prosecution.

[00:20:12] Speaker 03:
Accommodation to patient effort or controlled by the patient is defined primarily as synchronization, same continuation in line 66, is defined

[00:20:23] Speaker 03:
primarily a synchronization of the ventilator's inhale and exhale phases with the phases of the patient's effort.

[00:20:30] Speaker 03:
The whole discussion earlier, almost all of it, was about the volume, monotonous volume, that it makes up the difference.

[00:20:37] Speaker 03:
But the truth is, in his prosecution history, the patentee says, the distinction here is that we wholly control, in our invention, he says,

[00:20:51] Speaker 03:
Stoicke was an assisted ventilation.

[00:20:53] Speaker 03:
In ours, we wholly control rate and volume.

[00:20:57] Speaker 03:
And Judge Fogel asked the question, isn't this just running a predetermined pattern?

[00:21:01] Speaker 03:
And exactly what it is.

[00:21:02] Speaker 03:
All the examples show where they took a mammal, in this example, a dog, put it under, and just recorded its natural rhythms of volume and rate.

[00:21:13] Speaker 03:
And rate's very important.

[00:21:15] Speaker 03:
Stowicki is going to synchronize the timing of the inhale and exhale.

[00:21:20] Speaker 03:
In the First Amendment, the patentee relied on this control of the rate and the volume.

[00:21:30] Speaker 03:
Ten times they mentioned the rate and volume, the control, and the predetermined pattern of rate and volume.

[00:21:36] Speaker 03:
In the Second Amendment, this distinction blew.

[00:21:38] Speaker 03:
They still said ten times they referred to the rate and volume control.

[00:21:43] Speaker 03:
But the predetermined pattern and the rate of control is only part of the First Amendment.

[00:21:49] Speaker 03:
The First Amendment had two amendments.

[00:21:53] Speaker 03:
In the first instance, they said, we're going to distinguish the WICCI on the basis of controlled life support conditions.

[00:22:00] Speaker 03:
And then they said, in contrast to WICCI, we are not in controlled life support conditions.

[00:22:05] Speaker 03:
Can I have a drink, please?

[00:22:08] Speaker 03:
And then they said, even with the WICCI,

[00:22:12] Speaker 03:
even on that distinguishing point, we're going to add predetermined pattern, or make the pattern predetermined.

[00:22:19] Speaker 03:
And so the arguments, if you look at the First Amendment, clearly had a first set of arguments about controlled life support conditions where they defined it, and then a second thing where they discussed the pattern and the monotonous tones.

[00:22:33] Speaker 03:
And if we read the full quotes from the prosecution history, and not the ones from the court's brief, we turn to that is at page

[00:22:43] Speaker 03:
Let's start here.

[00:22:45] Speaker 03:
We're going to get to A607.

[00:23:05] Speaker 03:
So, just as they started in, as Patty started on A607, about the one, two, three, fourth paragraph, the present invention is concerned with controlling the flow of biological fluid to an organ during controlled by support conditions.

[00:23:21] Speaker 03:
And then it says the species is one which wholly controls the flow of ventilating gas.

[00:23:30] Speaker 03:
Let's turn to page four, or page 608, the next page, the first full paragraph.

[00:23:35] Speaker 03:
The Stowicki device, as relied on by the examiner, is concerned primarily with the weaning type of ventilator, which provides assisted ventilation to a patient, rather than the present invention, which is concerned with ventilation during controlled life support conditions.

[00:23:49] Speaker 03:
He's drawing a distinction of the treatment conditions, the circumstances of the patient here.

[00:23:56] Speaker 03:
To grasp the seriousness of his amendment, in the First Amendment, he added controlled life support conditions to three out of the four paragraphs of claim one.

[00:24:05] Speaker 03:
He added predetermined to describe pattern in only one of the elements.

[00:24:10] Speaker 03:
I mean, this was a very significant amendment that he made.

[00:24:13] Speaker 03:
And his arguments speak to that.

[00:24:17] Speaker 03:
And let's just, with the earlier discussion, the earlier case, I think, talked about the disjunctive or conjunctive.

[00:24:23] Speaker 03:
And let's show that he actually links his two arguments.

[00:24:25] Speaker 03:
He has a first argument and a second argument that he relies on, just as he had a First Amendment and a Second Amendment.

[00:24:31] Speaker 01:
Can you say that this device wouldn't work if the patient was breathing?

[00:24:38] Speaker 03:
The claim device.

[00:24:42] Speaker 03:
The claim device.

[00:24:42] Speaker 03:
I don't see any way it would work.

[00:24:44] Speaker 03:
Stowicki says when the patient's breathing, the examples in the patent show they take a recording

[00:24:51] Speaker 01:
and the example i think i think that they looked at all the time it was pretty clear that that it certainly meant to work in a situation where patients not agree so you're you're creating the you're mimicking the the breathing of a mammal opposed to a monotonous flow that that's hard to get but where does it say in there that it wouldn't work if there was a patient let me say this first of all there's no question related to that which is

[00:25:15] Speaker 03:
Stoicke has much disclosure about how to accommodate patient effort.

[00:25:18] Speaker 03:
All the software and all the disclosure here, there's never a teaching to one ordinary skill in New York how to accommodate patient effort in the 350 pattern.

[00:25:27] Speaker 03:
Every example that's run is how to, they actually control both rate and timing, or rate and volume.

[00:25:37] Speaker 03:
If you dictate the rate, you are not accommodating the patient's initiation of inhalation and exhalation.

[00:25:43] Speaker 03:
You just can't do it if you're controlling, if you're holding control.

[00:25:46] Speaker 03:
10 times they use those conjunctive terms.

[00:25:49] Speaker 03:
Now look, if I may, quickly, page five, or page 609, and again, after talking about Stowicki, it says, this operation is quite different from the operation of the present invention, where the ventilator's operated during controlled life support conditions and not under weaning conditions.

[00:26:06] Speaker 03:
So that's his first point.

[00:26:09] Speaker 03:
And, in which he's first established a predetermined pattern.

[00:26:13] Speaker 03:
Plaintiff has talked about predetermined pattern through all this time, and he omits, conveniently, all the discussion about the distinction in controlled life support conditions of an assisted, he says, Stowicki is an assisted, ours is a controlled.

[00:26:29] Speaker 03:
He used controlled life support conditions.

[00:26:31] Speaker 03:
In the patent, he says, oh, at column one, there's a disclosure of, it says assisted or life support conditions,

[00:26:41] Speaker 03:
and another thing with healthy conditions.

[00:26:44] Speaker 03:
But even there, they're consistent.

[00:26:46] Speaker 03:
The critically ill patients are under life support.

[00:26:49] Speaker 03:
Note the claim term, controlled life support conditions.

[00:26:53] Speaker 03:
The healthy patients, he doesn't say they're under control, under life support.

[00:26:57] Speaker 03:
They're just healthy patients who may be.

[00:26:59] Speaker 03:
The truth is also, even if the, I don't think there's any disclosure about healthy patients and whether they're breathing or not.

[00:27:05] Speaker 03:
We don't know what a healthy patient is.

[00:27:07] Speaker 03:
We don't know what elective surgery is.

[00:27:09] Speaker 03:
I had my hip replaced.

[00:27:10] Speaker 03:
It was elective.

[00:27:11] Speaker 03:
But I believe I was out and somebody was controlling my breathing during the surgery.

[00:27:17] Speaker 03:
But even if there was an explicit preferred embodiment in the specification teaching a circumstance where there could be breathing under something.

[00:27:32] Speaker 03:
The specification does not limit the invention.

[00:27:36] Speaker 03:
The claims limit the invention.

[00:27:38] Speaker 03:
And frequently, the claims do not allow, do not cover even preferred embodiments in the specification.

[00:27:45] Speaker 03:
You can just claim preferred embodiments.

[00:27:47] Speaker 03:
Whether or not this thing actually described healthy patients under process of this process, I don't see how the process could ever work.

[00:27:59] Speaker 03:
if you dictate the rate and the volume with the patient who's trying to breathe on his own.

[00:28:03] Speaker 00:
Right, because without taking into account what the patient is doing, the patient may be out of sync with whatever the sinusoidal wave is, or it may be in sync but contributing peaks that are way too high.

[00:28:19] Speaker 03:
The wiki talks about a problem of fighting the ventilator, it calls it, where you're not in synchronization.

[00:28:24] Speaker 03:
in where a patient wants to breathe and the ventilator is in an opposite phase or something like that.

[00:28:31] Speaker 00:
A lot of damage to the lungs when you fight it.

[00:28:33] Speaker 00:
Can you answer the question I asked you to address about the wiki, where it describes

[00:28:40] Speaker 00:
a waveform contribution, and the answer may be it is inherent in inhale, exhale, inherent in title, inherent in some other things.

[00:28:51] Speaker 00:
The abstract refers to waveform, but can you point me, because there was some mention during your friend's opening argument about the distinction being between his invention and Stowicky, that Stowicky provides a monotonous

[00:29:09] Speaker 00:
contribution by which I took to mean a constant rate of fluid, no ups and downs, not sinusoidal.

[00:29:22] Speaker 03:
I'm trying to put my hands on where the wiki is in my exhibit list.

[00:29:26] Speaker 00:
It's 792 in the appendix.

[00:29:28] Speaker 03:
Thank you very much.

[00:29:33] Speaker 03:
Stoicke has examples, and I don't believe I'm going to point quickly to them, where it accommodates different events that occur with the patient.

[00:29:43] Speaker 03:
For example, if the patient coughs.

[00:29:46] Speaker 00:
Right.

[00:29:46] Speaker 00:
Let me try to, which may be confused.

[00:29:49] Speaker 00:
You could have a monotonous flow produced by taking into account at every single instant what the patient is doing.

[00:30:02] Speaker 00:
subtracting that from the amount you're going to contribute, but that the net contribution is constant.

[00:30:09] Speaker 00:
I took the word monotonous that he was using to mean that.

[00:30:14] Speaker 00:
Maybe I took it wrong.

[00:30:17] Speaker 00:
It would not look like inhaling and exhaling.

[00:30:24] Speaker 00:
There would be no down period of net intake.

[00:30:29] Speaker 00:
which strikes me as odd, but I'd like you to show me in Stawitki where Stawitki contemplates that after taking into account any patient contribution, what a patient is getting looks sinusoidal or anything but monotonous.

[00:30:59] Speaker 03:
I believe, and you're only speaking about monotonous in terms of volume, not in terms of rate.

[00:31:17] Speaker 03:
I think his claim requires both monotonous control of both.

[00:31:28] Speaker 03:
do you see anything, Dusty, do you, the discussions?

[00:31:33] Speaker 00:
Do you happen to know how to interpret on page A, 800, figure 11B?

[00:32:05] Speaker 00:
That looks like a waveform to me, but maybe it's not a relevant waveform.

[00:32:14] Speaker 03:
It doesn't look like it's monotonous if it is.

[00:32:20] Speaker 03:
It's only a volume.

[00:32:21] Speaker 03:
It's volume over time, but it shows that the different breaths had different

[00:32:32] Speaker 00:
That's okay.

[00:32:34] Speaker 03:
I'm just sorry.

[00:32:36] Speaker 03:
I don't... I'm just not sure if you're trying to find out whether Stowicki actually teaches at the endpoint of inhalation, varying the volume of the patient from breath to breath.

[00:32:58] Speaker 03:
the ultimate what we call tidal volume, the volume that's received by the patient, whether by his own effort or by the machine.

[00:33:06] Speaker 03:
I'm not sure if that's your question or the degree of assistance changes diminished as elasticity changes, the pressure changes, it controls it by varying the pressure to reach

[00:33:20] Speaker 03:
oxygenation, I think it talks, and I don't have the exact site, I think it talks to minute volume which monitors how much the patient was getting, if the patient fought or coughed or did something, it tracks

[00:33:37] Speaker 03:
over a minute, not just breath to breath, but they say, well, this patient needs X amount of volume, minute volume per minute, then we're going to make up more, depending on what they've already done, we'll make it up to ensure that the average for the minute, the minute volume, will meet the prescribed oxygenation rates.

[00:33:58] Speaker 03:
And frankly, I just didn't contemplate that question here, and I just don't understand.

[00:34:08] Speaker 03:
Thank you.

[00:34:11] Speaker 03:
I'm colorblind, but I think my time is up.

[00:34:13] Speaker 03:
Is that correct?

[00:34:14] Speaker 03:
Yes, sir.

[00:34:15] Speaker ?:
Thank you.

[00:34:39] Speaker 02:
What Mr. Jones said last is my point exactly.

[00:34:43] Speaker 02:
Stoicke is intended to make sure that a patient gets a target or prescribed volume of oxygen in addition to whatever the patient is provided.

[00:34:53] Speaker 02:
So if we look at page 808, this is Stoicke, and we look at column 13.

[00:35:00] Speaker 02:
This is describing one of the equations that Stoicke implements.

[00:35:04] Speaker 02:
Thus, for breaths with added resistance... We are on column... I'm sorry, column 13, line 5.

[00:35:13] Speaker 02:
So this is the resistance that Mr. Jones was talking about.

[00:35:16] Speaker 02:
Thus, for breaths with added resistance, if patient efforts cause the actual flow rate, DV over DT, to be less than the prescribed rate, flow target, then the pressures to the patient are increased.

[00:35:29] Speaker 02:
Similarly, when the patient causes the actual flow rate to exceed flow target, the applied pressures are diminished.

[00:35:36] Speaker 02:
The point is, it's the wiki wants the patient to get the same volume of air, taking into account however much the patient is breathing.

[00:35:46] Speaker 02:
That is different than the 350 patent, and that was the distinction made in the prosecution history.

[00:35:52] Speaker 02:
Now, as far as no embodiments of Mr. Jones said that taught patient assistance,

[00:35:58] Speaker 02:
As I mentioned before, IAVC, which does talk about blood, but that is part of these claims, talks about the patient providing inadequate blood flow.

[00:36:08] Speaker 02:
So that is a circumstance where this invention is intended to work with a patient's efforts, not independent of them, not ignoring them.

[00:36:18] Speaker 02:
So the patent very clearly

[00:36:20] Speaker 02:
enable someone to take this invention and apply it where the patient is able to provide some of his own surgical fluids.

[00:36:30] Speaker 04:
Thank you.