[00:00:17] Speaker 01:
okay the next case before the court is an appeal from a decision of the patent trial and appeal board it is inova lab versus inagen inc case number one five one oh six seven Mr. Myertons you want three minutes for rebuttal

[00:00:48] Speaker 01:
We may begin.

[00:00:54] Speaker 00:
Eric Myertens for Nova Labs.

[00:00:57] Speaker 00:
We respectfully submit that the board committed two errors.

[00:01:00] Speaker 00:
The first error was not ever considering the combination of Hakenin with the admitted prior error.

[00:01:07] Speaker 00:
There's absolutely no consideration of it whatsoever.

[00:01:11] Speaker 03:
Did you make an argument to the board that if Hakenin

[00:01:19] Speaker 03:
does not show user control of the potentiometer that that element of the claim can be found in the so-called admitted prior art?

[00:01:32] Speaker 03:
I didn't see such an argument.

[00:01:33] Speaker 00:
It wasn't specifically stated in that way, but what was stated was that the combination of Hakenham with the admitted prior art view that combination, it would be obvious to have user selectability in context with the other elements of the claim.

[00:01:48] Speaker 00:
So that combination was specifically stated in our briefing before the board.

[00:01:52] Speaker 03:
But I guess here's maybe a slightly different way of saying it.

[00:01:56] Speaker 03:
I took your argument to the board, and tell me if I'm wrong, that that combination argument itself took as a premise that Haykinen showed user control.

[00:02:11] Speaker 00:
No, that's not accurate, Your Honor.

[00:02:14] Speaker 00:
The argument to the board was that

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Hakinen teaches a potentiometer that shows the ability to have selectivity.

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The argument that we made to the board was that it's not limited to anybody, and it isn't.

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There is absolutely nowhere in the reference where it's limited as to who can use it.

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And we said that because of the computer, 100 and Hakinen, that computer is connected up to the system that has the potentiometer, and it's specifically tied together in the pattern.

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And we said that it would be obvious

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in view of the Hakinen teaching which teaches all the apparatus features that you need to practice this invention.

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It would be obvious in view of the admitted prior art to go ahead and have a user, a patient do it, to exchange between night and day modes.

[00:03:01] Speaker 00:
It's true that the Hakinen reference does not specifically state you have to have a day mode and you have to have a night mode.

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Hakinen doesn't say that.

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But Hakinen does say you can adjust the sensitivity of the potentiometer

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in order to adjust the inhalation inspiration pressure.

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But it doesn't talk about user adjustment.

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It doesn't talk about any limitation whatsoever as to who can do the adjusting.

[00:03:25] Speaker 02:
Let me ask you, help me get my mind around exactly what your argument looks like.

[00:03:33] Speaker 02:
I take it you agree with your colleagues on the other side that Hakenin is the key issue.

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Is that correct?

[00:03:42] Speaker 00:
Haken is a key reference.

[00:03:44] Speaker 02:
He's a key reference.

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And indeed, your general discussion always talks about Haken and the APA applied.

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What is it?

[00:03:57] Speaker 00:
Admitted prior art.

[00:03:58] Speaker 02:
Admitted prior art.

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But you don't specify what that is.

[00:04:01] Speaker 02:
It's a lump.

[00:04:02] Speaker 02:
OK.

[00:04:03] Speaker 00:
No.

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It's the background section of the 343 patent.

[00:04:05] Speaker 02:
That's what it's about.

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What a prior art

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patent in this case, the Haken and Patent Teaches is a question of fact.

[00:04:19] Speaker 02:
Do you agree with that?

[00:04:21] Speaker 00:
I think it's a matter of law, Your Honor.

[00:04:23] Speaker 00:
Really?

[00:04:24] Speaker 00:
I don't think you need an expert to tell you what it teaches.

[00:04:27] Speaker 00:
I think you can read it.

[00:04:29] Speaker 01:
The case law says that what Prior Art teaches for purposes of 103 is a question of fact.

[00:04:36] Speaker 01:
It's an odd concept because the patent itself

[00:04:41] Speaker 01:
We've always said construing it with the question of law with now the overlay of Teva, but with respect to what the prior patent is, it's a question of fact.

[00:04:51] Speaker 00:
Okay.

[00:04:51] Speaker 00:
Well, it says what it says and there's no dispute as to that.

[00:04:54] Speaker 02:
Well, let's assume, I understand you are coming at this as a question of law, but let's assume it's a question of fact.

[00:05:02] Speaker 02:
Okay.

[00:05:02] Speaker 02:
What is the standard of review that this court should apply to a finding of fact by an administrative agency?

[00:05:09] Speaker 00:
It's substantial evidence, Your Honor, I believe.

[00:05:12] Speaker 02:
Meaning that on the basis of the record, if reasonable minds could have gone that way.

[00:05:18] Speaker 02:
Right.

[00:05:21] Speaker 02:
You're facing a situation in which three of the Patent Trial and Appeal Board judges agreed that this is the right way to read Hagan.

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Is it your argument that

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They are unreasonable minds.

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No reasonable mind could have come out where they come out.

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Is that your position?

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Well, I agree with them to the extent that they say that Haykinen does not specifically specify that a user's selectivity.

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That's all they say.

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That's the only factual finding if such can be the case with respect to Haykinen.

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That's the only thing that they say about Haykinen.

[00:06:02] Speaker 01:
Well, in fact, don't they go a little further than that and say that Hagan contemplates that any adjustments would be made in the factory?

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In other words, that it is an internal to the machinery.

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That's not true.

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The board does not state that.

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That is an expert witness submitted by my esteemed friend.

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The board does not say that.

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The board never makes that finding.

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In fact, the board specifically does not make that finding.

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All the board says,

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is that, look, we've looked at this reference.

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We think the primary issue is to whether there's user selectability in HACNN.

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We can't tell whether there is or not.

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We don't find it in there.

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We don't say it's not in there.

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We just don't find it.

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And that's all the, quote, finding is from the board.

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There is absolutely no teaching within HACNN.

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of this concept of factory only or manufacturing, et cetera.

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In fact, if we're going to use declarations, there's a declaration in the record from a man named Bill Wilkinson who actually builds these machines and actually knows how to do this and has done it for many years.

[00:07:13] Speaker 00:
He says that this is absolutely known, that you would have the ability to do this.

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I think it's a dangerous ground to go into this area where we say, well, we've got one declaration, we have another declaration, neither of which has been deposed, neither of which has shown any testimony, and we're going to use that.

[00:07:29] Speaker 00:
to change what the reference that was written 25 years ago says.

[00:07:34] Speaker 00:
Why can't we just look at the reference and say that the reference says what it says, instead of trying to impute things into it?

[00:07:41] Speaker 00:
And that reference specifically has, in figure eight, figure eight is tied to all the other embodiments.

[00:07:48] Speaker 00:
There's a specific quote in the pen where it ties figure eight to all the other embodiments.

[00:07:54] Speaker 00:
Figure eight has the potentiometer in there.

[00:07:57] Speaker 01:
Right, but even in figure eight, it appears that the potentiometer is something that is encapsulated within the machinery.

[00:08:07] Speaker 00:
So what?

[00:08:08] Speaker 00:
A potentiometer has a knob on it, typically.

[00:08:10] Speaker 00:
It's like a TV or radio.

[00:08:13] Speaker 00:
Is a knob on a TV encapsulated within the machinery?

[00:08:17] Speaker 00:
No.

[00:08:18] Speaker 00:
When you talk about something that can be adjusted, it means you can have access to adjust it.

[00:08:23] Speaker 00:
It can be adjusted one of two ways.

[00:08:25] Speaker 00:
One, it could be like a knob.

[00:08:27] Speaker 01:
What is it then, if you're saying that, okay, I can see that Haykinen doesn't specifically teach user selectability, what is it in the prior art that you say fills that gap, teaches that limitation?

[00:08:43] Speaker 00:
Yes.

[00:08:45] Speaker 00:
The admitted prior art says that at night, people breathe shallower.

[00:08:52] Speaker 00:
Because they breathe shallower, they generate less inspiration and pressure.

[00:08:57] Speaker 00:
And so when you have one of these machines that it turns on and off based on the inspiration pressure, there's a need to adjust it between the daytime and the nighttime.

[00:09:06] Speaker 00:
That's what the admitted prior art says.

[00:09:09] Speaker 00:
And then you have the Hakenite reference, which says, here's a machine that allows you to adjust the inhalation sensitivity.

[00:09:16] Speaker 00:
Not you.

[00:09:18] Speaker 00:
It allows anybody.

[00:09:19] Speaker 00:
It doesn't say,

[00:09:21] Speaker 00:
that it's done in the factory.

[00:09:22] Speaker 00:
It doesn't say it's done in manufacturing.

[00:09:24] Speaker 00:
In fact, these machines in Hakinen are contemplated to be used for people with respiratory problems.

[00:09:29] Speaker 00:
They have different levels of inspiration sensitivities.

[00:09:32] Speaker 00:
And because they have different levels of inspiration sensitivities, the logical reading of Hakinen is that it would be done in the field by the people.

[00:09:40] Speaker 01:
So now you're going back to saying that Hakinen does disclose.

[00:09:44] Speaker 00:
No, I'm saying a logical reading.

[00:09:46] Speaker 00:
I think Hakinen just doesn't say it one way or another.

[00:09:49] Speaker 00:
And that's a bachelor truth.

[00:09:51] Speaker 00:
If you want to just, you know, read the reference and see what it says, it doesn't limit it.

[00:09:55] Speaker 00:
If a reference doesn't limit it.

[00:09:57] Speaker 00:
Okay.

[00:09:57] Speaker 00:
So you're not, this is, this is the problem.

[00:09:59] Speaker 01:
This is where we started with Judge Toronto.

[00:10:02] Speaker 01:
So as I understand your argument, it is that Hakinen does teach it and it's the admitted priority that helps you construe Hakinen to teach it.

[00:10:13] Speaker 00:
Hakinen teaches all the apparatus you need.

[00:10:15] Speaker 00:
It's got the machine there.

[00:10:16] Speaker 00:
But does it teach user selectability?

[00:10:18] Speaker 00:
It doesn't teach who actually does the selectability.

[00:10:22] Speaker 00:
The admitted prior art says, hey, at nighttime, you need to change it from day to night.

[00:10:27] Speaker 00:
And so there would be a reason to adjust it.

[00:10:30] Speaker 00:
And we're just saying that that's obvious.

[00:10:31] Speaker 01:
What's the practical impact of this for your district court action?

[00:10:36] Speaker 01:
I mean, you just didn't get to shortcut it with a re-exam, right?

[00:10:40] Speaker 00:
The district court action is stayed.

[00:10:43] Speaker 00:
And there is a claim of infringement against our client.

[00:10:46] Speaker 00:
for this claim.

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And so the practical reality is that we believe the claim is invalid.

[00:10:52] Speaker 00:
If that is upheld, then the infringement action goes away.

[00:10:56] Speaker 01:
But you could still argue invalidity at the district court, could you not?

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

[00:11:01] Speaker 00:
But as you know, there's both practical and legal obstacles.

[00:11:05] Speaker 00:
And anybody who knows, you go before a jury and you argue the same thing that's already been argued before another court, you've got to uphill battle.

[00:11:12] Speaker 00:
So this makes a big difference.

[00:11:15] Speaker 02:
to our client.

[00:11:16] Speaker 02:
So your gamble was that you had a better shot at getting invalidity from the PTAB than you would from the district court?

[00:11:24] Speaker 00:
With respect to the printed publications and patents, that's accurate.

[00:11:28] Speaker 00:
We have other prior art, which we will allege, but that's true.

[00:11:31] Speaker 00:
And by the way, that's why you see a lot of inter-party proceedings.

[00:11:34] Speaker 02:
There's a second step in all this, whatever Haken teaches, and that is what would one of ordinary skill in the art have done with all of that?

[00:11:45] Speaker 00:
Yes, yes.

[00:11:47] Speaker 00:
What would a person already skilled in the art, when you have a machine that does everything you need to adjust the sensitivity, and you know that the patient at night time needs a different sensitivity, what would you do as an ordinary person who knows the art?

[00:12:00] Speaker 00:
Maybe use that machine to change the sensitivity?

[00:12:02] Speaker 00:
The PTAB said no.

[00:12:04] Speaker 00:
The PTAB considered 11 different arguments.

[00:12:07] Speaker 00:
This is one that got lost in the mix.

[00:12:10] Speaker 00:
I think they made a mistake, and it happens.

[00:12:14] Speaker 00:
Honestly, you have a situation where you have the exact machine before you.

[00:12:22] Speaker 00:
If you have that machine and you know if you have the admitted priority, there's a need to adjust under KSR.

[00:12:30] Speaker 00:
The person of ordinary skill and art is not a tom tom, right?

[00:12:37] Speaker 00:
They have ordinary creativity.

[00:12:40] Speaker 00:
A person of ordinary creativity

[00:12:42] Speaker 00:
ordinary skill and art, would say, hmm, maybe I ought to use the machine for the problem that I'm facing, which is the exact same problem that the machine solves.

[00:12:55] Speaker 01:
Okay, you're into your rebuttal time.

[00:12:57] Speaker 01:
I'll save my rebuttal.

[00:12:58] Speaker 01:
Thank you.

[00:12:59] Speaker 04:
Good morning, Your Honors, and may it please the Court.

[00:13:08] Speaker 04:
We believe that the board did have substantial evidence to reach its conclusion that the prior ARC combinations presented by appellant did not disclose the two core claim limitations that we're really disputing here, the user selectability and picking a level, a lower level at least, that's correlated to a patient state of inactivity and a lower breathing activity.

[00:13:34] Speaker 01:
Why doesn't this fall, as your friend on the other side ended with,

[00:13:38] Speaker 01:
the KSR concept of what someone would reasonably conclude, looking at HACN, even if it doesn't teach user selectability, why isn't the concept of user selectability something that would easily tumble to any person of skill in the arts?

[00:13:56] Speaker 04:
Well, I think the board, number one, addressed that by concluding that HACN not only has insufficient disclosure, but that it does not teach either of the limitations.

[00:14:04] Speaker 04:
That's at A22 in the board decision.

[00:14:07] Speaker 04:
And the argument, if you're going to talk about what the person of skill brings to the table, we have to bring everything to the table, including knowledge about the other prior arc.

[00:14:20] Speaker 04:
And Taken in himself solves this problem a different way.

[00:14:25] Speaker 04:
He points out in his patent that he uses an auto-fire mode.

[00:14:30] Speaker 04:
So if the patient has not had a breath for a certain amount of time,

[00:14:35] Speaker 04:
The system will, based on a timer, automatically deliver a breath.

[00:14:41] Speaker 04:
He explains in his declaration at paragraph 13 that that auto-firing is his solution.

[00:14:51] Speaker 04:
The so-called admitted prior art in the background explains other ways to address this problem in the prior art.

[00:14:58] Speaker 04:
Continuous flow of oxygen to the patient.

[00:15:01] Speaker 04:
an apnea alarm, which would sound off and awake the patient if they had not taken a breath in a certain amount of time.

[00:15:08] Speaker 04:
So what a person of skill in the art would be taught from the art as a whole is that the direction is to give the respiration apparatus, give the system an override capability to deal with a situation where a patient is having a shallow breath and

[00:15:29] Speaker 04:
for some reason the system isn't delivering the breath.

[00:15:32] Speaker 04:
Where we disagree with the appellant and where the board came down on our side as well is that somehow that's just alleged admitted prior art which identifies the physiological fact that your breathing pattern may change at a lower activity level.

[00:15:52] Speaker 04:
At sleep your breathing pattern is shallower.

[00:15:54] Speaker 04:
And so leap from that to saying

[00:15:57] Speaker 04:
because of that physiological phenomenon, which persons of skill in the art had known about for many years and had chosen to address in the systems completely different ways, again, giving the system more control, not giving the control to the user.

[00:16:12] Speaker 02:
As I see the basic difference between the prior art taken as a whole and your invention, if I understand it correctly, is that we made the shift from

[00:16:25] Speaker 02:
having the adjustment process handled by the professionals in the field, or in the manufacturer, or wherever, to suddenly making it available to the patient to make those adjustments?

[00:16:41] Speaker 04:
Correct.

[00:16:41] Speaker 02:
Is that the essential, inventive step that we can use that phrase?

[00:16:48] Speaker 04:
I would agree, Your Honor.

[00:16:50] Speaker 04:
And actually, you can expand upon that.

[00:16:52] Speaker 04:
But if Your Honor's question continues

[00:16:54] Speaker 04:
The way I would expand upon it also is to say that in some situations the way that was being adjusted by professionals, this triggering level, threshold level being adjusted by professionals, was to tune the system to be to a particular level as opposed to then this other concept is now we're going to rather than pick a single optimized standardized level where now we can

[00:17:24] Speaker 04:
use that to base our strategy for the rest of the respiratory therapy and the rest of the parameters that the clinician might be controlling.

[00:17:32] Speaker 04:
We're now giving a lower level to the patient when the patient's inactive and potentially other levels depending on which claim we're in.

[00:17:41] Speaker 04:
Claim one, specify the lower level.

[00:17:43] Speaker 04:
Claim two, specify more levels and so on.

[00:17:46] Speaker 04:
So we're not only moving who does the adjustment, but we're coming up with this idea of multiple levels

[00:17:54] Speaker 04:
that you can return to as opposed to just simply calibrating and fine-tuning.

[00:18:00] Speaker 04:
We now have this additional concept.

[00:18:02] Speaker 02:
There's an interesting parallel when it used to be that when you were in the hospital having had surgery or some other invasive activity, if you wanted pain relief, you pushed the button on the call button and the nurse or the doctor would come in and determine

[00:18:24] Speaker 02:
what your need was and whether it was timely.

[00:18:27] Speaker 02:
Nowadays I understand they give you a little box and you can push the button on the box and the box controls how much you get but you can self-medicate up to a point which is essentially the difference I take it between the prior art in your case and what you're alleging is the invention here.

[00:18:51] Speaker 02:
Is that fair?

[00:18:52] Speaker 04:
Your Honor, I think that's an interesting analogy, and I think there are definitely some parallels, but I think that the system here that we're claiming has a few more moving parts, if you will, in that there are other issues to be set just simply besides do I take a dose, and whether that dose happens to be delivered intravenously to the patient in your Honor's analogy, or whether it's the patient choosing to swallow a pill

[00:19:21] Speaker 04:
perhaps.

[00:19:24] Speaker 04:
I think there are fewer therapeutic or clinical variables involved compared to the respiratory apparatus that we're claiming.

[00:19:32] Speaker 04:
But the general direction of patient control, that is absolutely something that we're doing.

[00:19:41] Speaker 02:
So why isn't, in light of all these other moves in that direction, why isn't this whole thing, remember the second step, what would someone

[00:19:50] Speaker 02:
whatever Hackenon teaches, why wouldn't someone of ordinary skill in the art have wanted to do this and have seen the need and have said, oh, that seems like a sensible thing to do.

[00:20:05] Speaker 02:
Common sense sort of thing.

[00:20:07] Speaker 04:
Correct.

[00:20:08] Speaker 04:
And to begin with, the way the prior art combinations were phrased and the way the arguments were presented at the board, it was simply Hackenon

[00:20:20] Speaker 04:
plus the admitted prior art and no references to the kinds of user control, the drug delivery system that your honor is talking about.

[00:20:30] Speaker 04:
But again, I think that when we add in the fact that the purpose that the fine-tune calibration in Hakinen was being used for, and this is something that all of the declarants- Did the board address

[00:20:49] Speaker 03:
the contention that Hakunin is silent about who uses the potentiometer.

[00:20:59] Speaker 03:
The admitted prior art, and I gather this is now undisputed, discloses that levels of delivery might be usefully changed between night and day because you breathe differently.

[00:21:19] Speaker 03:
And that it is obvious from that combination that the patient can be one of the people to use the potentiometer.

[00:21:34] Speaker 04:
Your Honor, let me start with the middle point in your question that set up the conclusion.

[00:21:41] Speaker 04:
The middle point being, are we admitting that the alleged admitted prior

[00:21:45] Speaker 04:
says change the threshold pressure levels?

[00:21:48] Speaker 04:
No.

[00:21:49] Speaker 03:
No, I'm sorry, I didn't mean to say that.

[00:21:52] Speaker 03:
The admitted prior art, and I think you said earlier, it was well known that people breathe differently at night from the way they breathe during the day.

[00:22:02] Speaker 03:
So that, you have that, and it could be even confirmed in the admitted prior art.

[00:22:08] Speaker 03:
At page A463, Inova made an argument

[00:22:15] Speaker 03:
quite like this.

[00:22:16] Speaker 03:
So my first question is, did the board address it?

[00:22:21] Speaker 04:
I don't believe the board expressly refers to the APA in its decision.

[00:22:28] Speaker 04:
However, I submit that the APA really adds nothing above and beyond what we can tell from the Hackinen reference itself, namely that we... Well, then maybe there are two things the board didn't address.

[00:22:45] Speaker 03:
It didn't address the question of motivation of a reader of Hakunin to have the patient be one of the people who would use the knob, the potentiometer, or same motivation drawn from the admitted prior art teaching that

[00:23:11] Speaker 03:
people need different levels of the oxygen at night from what they need during the day.

[00:23:17] Speaker 04:
Your Honor, the reason I wouldn't go that far is because at the board level, the focus of the dispute on this issue was largely about the declarations that had been submitted.

[00:23:27] Speaker 04:
We had a declaration from Hacken and the inventor, from Wenzel, an expert, from Mr. Taylor, the inventor and founder, and also from

[00:23:35] Speaker 04:
the appellant had a declarant.

[00:23:37] Speaker 04:
But the appellant's argument at the board was that all of our declarations should be disregarded.

[00:23:43] Speaker 04:
They were improper in format, effectively inadmissible as opposed to being relevant to this very issue of knowing about hacking in, having disclosed an adjustable potentiometer,

[00:23:59] Speaker 04:
for what it discloses.

[00:24:01] Speaker 04:
What does it disclose?

[00:24:02] Speaker 04:
And?

[00:24:03] Speaker 03:
Well, I'm taking as a given here that the correctness of the board's finding that Hakkinen does not say who uses the thing.

[00:24:12] Speaker 03:
It is just silent, which seems to me right, and I'm not sure the board goes further than that.

[00:24:18] Speaker 03:
But it's just silent.

[00:24:20] Speaker 03:
That leaves the question, might an ordinary skilled artisan say, OK, it shows me a device that plainly

[00:24:30] Speaker 03:
enables adjustments by somebody, hasn't said who.

[00:24:36] Speaker 03:
There's not a professional machine operator at twilight and dusk and in the morning to change things.

[00:24:48] Speaker 03:
Why isn't it obvious that the patient can be somebody who does that?

[00:24:52] Speaker 03:
uh... because i think our declaring uh... established the the factual record uh... to the contrary but i think that the board and i thought that maybe and maybe that would be enough if the board sent something about that with where did that so that's where i started let me return to where did the board notwithstanding the well-known phenomenon that people need different amounts of oxygen when they're breathing differently night and day and a machine

[00:25:21] Speaker 03:
enables adjustment, I haven't said by whom, of the oxygen delivery level, that it's not obvious for the patient to be able to do that.

[00:25:32] Speaker 04:
Well, by adopting the declarations and the discussions at A23 and A24, which set forth those very, that very conclusion, Your Honor, is set forth in the Wenzel Declaration that the Board is saying is appropriate to give weight to it.

[00:25:47] Speaker 04:
And I think also by saying that hacking

[00:25:50] Speaker 04:
the conclusion that we don't agree with the requester on, this is at 822, we don't agree with the requester that Hackington teaches either of the limitations.

[00:25:59] Speaker 04:
And so that teaching is through the eyes of the person of skill in the art who would understand that there's a potentiometer in there.

[00:26:06] Speaker 03:
Well, suppose I read the teaching part.

[00:26:08] Speaker 03:
I do want to get back to the 23, 24.

[00:26:10] Speaker 03:
The teaching part is simply saying in the usual scope of prior art, content of prior art, deer, whatever, element, whatever,

[00:26:19] Speaker 03:
Hakinen does not communicate that idea.

[00:26:25] Speaker 03:
The next step is what might a relevant skilled artisan with whatever Hakinen does communicate plus other knowledge think of?

[00:26:36] Speaker 04:
And I think that if we're gonna parse the opinion a bit earlier, the previous paragraph, the board says there's insufficient disclosure about user selectability and then it goes further

[00:26:49] Speaker 04:
and said, there's no teaching.

[00:26:51] Speaker 04:
So I think the teaching refers to not just the express disclosure, but the message that would be understood by the skilled artisan.

[00:27:01] Speaker 04:
And again, we have all of these declarations telling us the reason Hackinen allows adjustment is for this fine tuning in the factory.

[00:27:10] Speaker 04:
It's something you don't want to fiddle with afterwards.

[00:27:13] Speaker 01:
Right.

[00:27:13] Speaker 01:
So the board finds that Hackinen doesn't teach

[00:27:17] Speaker 01:
the limitation.

[00:27:21] Speaker 01:
The admitted prior art might give you some motivation to find another way to do this but there's nothing in the admitted prior art to combine with.

[00:27:31] Speaker 04:
There's nothing to combine with and I think the admitted prior art says go in the other direction, make the machine smarter, make it override this situation and automatically.

[00:27:42] Speaker 03:
Isn't the evidence on that in fact?

[00:27:45] Speaker 03:
There's evidence on both sides about

[00:27:47] Speaker 03:
Is that your guy Wilkinson, is that his name?

[00:27:49] Speaker 03:
Winslow was our... Winslow was your guy there, Wilkinson?

[00:27:52] Speaker 03:
Correct.

[00:27:53] Speaker 03:
But it seems to me that the declarations, they had two declarations, you had one.

[00:27:58] Speaker 03:
They basically go opposite ways about what somebody with the hack and end machine sitting in front of him would think.

[00:28:08] Speaker 03:
Did the board resolve that dispute?

[00:28:12] Speaker 04:
I believe it did, Your Honor.

[00:28:13] Speaker 04:
Where?

[00:28:14] Speaker 04:
I think they deserve deference.

[00:28:15] Speaker 04:
Well, they resolved it.

[00:28:16] Speaker 04:
Because number one, Wenzel never actually, I'm sorry, Mr. Wilkinson, a talent expert, never actually talked about the motivation.

[00:28:29] Speaker 04:
He never actually opined on this very issue.

[00:28:32] Speaker 02:
Counsel, here's what the board said and what I think is troubling Judge Geranto.

[00:28:38] Speaker 02:
The board says, accordingly, this is the last paragraph of the section dealing with claims

[00:28:46] Speaker 02:
1 and 3 on page 6 of the appendix.

[00:28:51] Speaker 02:
Accordingly, we do not agree with the request that Hackenon features either of the limitations at issue in solo independent claims 1 or 8.

[00:29:00] Speaker 02:
As such, all of the rejections involving Hackenon are deficient as set forth by the examiner and argued by patent donor.

[00:29:11] Speaker 02:
We therefore sustain the examiner's non-adoption of rejections 1 through 6.

[00:29:19] Speaker 02:
And that makes it sound like what they dealt with was the specific arguments set forth by the examiner argued by the patent owner.

[00:29:31] Speaker 02:
Is that, was that the result in this?

[00:29:35] Speaker 02:
Is that how you read that?

[00:29:37] Speaker 02:
They don't say anything else about the whole thing because the whole rest of that discussion, which is the only board discussion with regard to claim one,

[00:29:46] Speaker 02:
beginning on page five and over into page six is a discussion of what Hakkinen reveals.

[00:29:54] Speaker 02:
The potentiometer doesn't go either way.

[00:29:56] Speaker 02:
They don't say anything either way.

[00:29:58] Speaker 02:
But then their conclusion simply is all of the rejections involving Hakkinen are deficient as set forth by the examiner and argued by patent donor.

[00:30:12] Speaker 02:
We therefore sustain the examiner's non-adoption

[00:30:15] Speaker 04:
And as the Pelham's counsel pointed out, they raised about a dozen different rejections in combination with Hacken and at a 448 in their notice of appeal to the board.

[00:30:30] Speaker 04:
They tried combining Hacken in many, many different ways.

[00:30:34] Speaker 02:
So you think this is simply a summary of all of that discussion and argument that had gone up.

[00:30:40] Speaker 04:
Correct.

[00:30:43] Speaker 02:
Okay.

[00:30:44] Speaker 01:
Okay, thank you.

[00:30:45] Speaker 04:
Thank you very much, Your Honors.

[00:30:47] Speaker 01:
We'll give you your full three minutes for rebuttal since we went over a little bit here.

[00:30:51] Speaker 00:
Thank you, Your Honor.

[00:30:55] Speaker 00:
No, the Board did not address the combination of HACLA with the admitted prior art whatsoever at all.

[00:31:01] Speaker 01:
What in the prior art, I mean, I understand what you're saying about the prior art providing the motivation.

[00:31:07] Speaker 01:
Right.

[00:31:07] Speaker 01:
But what in the prior art are we going to be combining with?

[00:31:10] Speaker 01:
I mean, in other words, you still have a limitation that's missing.

[00:31:12] Speaker 00:
Exactly.

[00:31:13] Speaker 00:
You have the admitted prior art which says that there is a need to change the inspiration pressure at night.

[00:31:20] Speaker 00:
Right.

[00:31:20] Speaker 00:
That's a motivation to combine.

[00:31:23] Speaker 00:
That is a motivation to use the haploid device to change the inspiration pressure at night.

[00:31:28] Speaker 00:
So you're saying it's a motivation to completely

[00:31:31] Speaker 00:
to just use it.

[00:31:32] Speaker 00:
You don't have to revamp it at all.

[00:31:34] Speaker 00:
You take the machine as Hakla taught and you change it to change the inspiration pressure at night.

[00:31:40] Speaker 00:
To say that the user makes a difference as to patentability is like saying that I'm over here, so guess what, it's prior art and it's invalid, but now I'm the user, so suddenly the patent is valid?

[00:31:52] Speaker 00:
That doesn't really make sense.

[00:31:54] Speaker 00:
The motivation in the mid of prior art is that

[00:31:57] Speaker 00:
There is a need to use this at night.

[00:31:59] Speaker 00:
That's the only inventive step that was identified.

[00:32:03] Speaker 03:
And it doesn't change the physical structure at all.

[00:32:06] Speaker 03:
It doesn't change the physical structure.

[00:32:07] Speaker 03:
It might, I guess, depending on... I mean, Hakkinen teaches a potentiometer.

[00:32:13] Speaker 03:
It doesn't say one way or the other where the controller for that is.

[00:32:18] Speaker 00:
But it has a computer connected to the system that has a potentiometer, and it has software that can be used to adjust therapeutic values.

[00:32:24] Speaker 00:
That's what it says.

[00:32:26] Speaker 00:
So it's a trivial matter to input a couple steps in there to have a computer change the therapeutic values, to change the potentiometer that Hacken and teaches.

[00:32:36] Speaker 00:
And the answer to your questions is no, they did not teach, the board did not address this, did not consider it, did not discuss it.

[00:32:42] Speaker 00:
The board did not talk about the motivation at all.

[00:32:44] Speaker 00:
And no, the board did not resolve the differences between the declarations.

[00:32:48] Speaker 00:
And in fact, the declaration of Bill Wilkinson specifically addresses

[00:32:52] Speaker 00:
A person of already skilled in the art would know that using HACLA's potentiometer to allow the user to adjust inhalation pressures is within the scope of HACLA's disclosure.

[00:33:02] Speaker 02:
Was there anything in all of your APA that pointed in the direction of user control rather than

[00:33:12] Speaker 02:
controlled by others, the manufacturer or the technicians or anything like that.

[00:33:19] Speaker 00:
I don't believe the APA addresses that one way or another.

[00:33:23] Speaker 02:
There's nothing in hacking in that.

[00:33:25] Speaker 00:
Haccala does not say who uses it, which means anybody can use it.

[00:33:28] Speaker 02:
So yeah, it means anybody can do it if you think of it.

[00:33:31] Speaker 02:
So the question is the one I put to your friend, which is, is the distinction between all of that prior art

[00:33:39] Speaker 02:
and their invention captured in that patent is the distinction of suddenly somebody thought of a way to give the user control.

[00:33:49] Speaker 00:
Well, I think that you did accurately say that's the purported advantage step in claim one.

[00:33:54] Speaker 00:
The thing is, though, the admitted prior art gives you the motivation to do that.

[00:33:59] Speaker 00:
The admitted prior art says, hey, it's different at night versus day.

[00:34:03] Speaker 00:
And as you have identified, when you're in a hospital,

[00:34:06] Speaker 00:
the patient a lot of times wants to press the button themselves.

[00:34:10] Speaker 00:
And that's well known and has been for quite some time.

[00:34:13] Speaker 02:
Nobody had thought to do that in this particular context, has it?

[00:34:18] Speaker 00:
Well, no one specifically says it.

[00:34:23] Speaker 02:
That's the key question.

[00:34:25] Speaker 00:
But yeah, if you want to really get down to the nub of it, here you have a motivation to do that, a teaching of an apparatus that can do it.

[00:34:34] Speaker 00:
So it's as if the nurse doing it is not patentable, but the patient doing it is.

[00:34:41] Speaker 00:
Is that the test for patentability?

[00:34:43] Speaker 00:
I don't think it is.

[00:34:45] Speaker 00:
If the prior art was limited, that would be different, but it's not.

[00:34:49] Speaker 00:
Okay, your time is up.

[00:34:50] Speaker 01:
The cases will be submitted.

[00:34:52] Speaker 01:
Thank you.