[00:00:00] Speaker 01:
Ms.

[00:00:00] Speaker 01:
Peronik, Schink vs. Zoll, Mehdi, 15-1485.

[00:00:38] Speaker 01:
Mr. DeFranco, you have reserved three minutes of your rebuttal.

[00:00:42] Speaker 01:
Sorry.

[00:00:43] Speaker 01:
Yes, your honor.

[00:00:47] Speaker ?:
OK.

[00:00:48] Speaker 01:
You may drink more water if you want.

[00:00:50] Speaker 00:
I'm all set.

[00:00:50] Speaker 00:
Thank you.

[00:00:51] Speaker 00:
I was thirsty, though, and I couldn't wait to get up here to have a swig.

[00:00:53] Speaker 01:
OK.

[00:00:54] Speaker 01:
You may proceed.

[00:00:54] Speaker 00:
May it please the court.

[00:00:56] Speaker 00:
My name is Denise DeFranco.

[00:00:57] Speaker 00:
I'm here on behalf of Appellant Respironics, Inc.

[00:01:01] Speaker 00:
Your honor, the issue in this case is whether the board correctly determined that the Owen publication

[00:01:06] Speaker 00:
and does not anticipate the challenge claims of the O03 patent.

[00:01:10] Speaker 01:
The board found that a single limitation in the challenge claims was not met in the O in reference, and that is P. Is your argument that the construction was incorrect or that the construction was correct, that it was erroneously applied?

[00:01:26] Speaker 00:
It's the latter, Your Honor.

[00:01:27] Speaker 00:
Basically, the board articulated the correct construction, data indicating whether a patient has

[00:01:33] Speaker 00:
instructions for use.

[00:01:35] Speaker 00:
But then when the board applied that claim construction to the Owen reference, the board added limitations in connection with each of the different disclosures of the Owen reference.

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In connection with the response button, the board added a narrow limitation that the reference had to disclose the time at which the instruction, please respond, is given to the patient.

[00:01:57] Speaker 00:
And in connection with the wear time indicator,

[00:01:59] Speaker 00:
the board added a narrow limitation to the otherwise broad and reasonable construction of patient compliance data, the limitation that the reference actually was required.

[00:02:11] Speaker 01:
But just to be clear, when you said the board added the subsequent limitation, now you're not saying that the board reconstrued the claim.

[00:02:20] Speaker 01:
They added the limitation in their application of the construction to the claim?

[00:02:27] Speaker 00:
Yes, Your Honor.

[00:02:29] Speaker 00:
describe it as that the board's claim construction, while articulated correctly, was morphed in the way that the board applied it to the prior art reference.

[00:02:37] Speaker 00:
And in that sense, the board did erroneously construe the claims, because the board did require the reference to disclose the time at which an instruction was given to a patient, and with respect to the wear time indicator, that the patient be told what the recommended wear time is.

[00:02:52] Speaker 03:
In particular, I understood the board is saying what the reference needs to teach in order to establish that

[00:02:59] Speaker 03:
the button presses were following an instruction for use is that there just has to be some comfort knowing that all the data points about button presses was in response to an instruction somehow and right now, as is, they didn't see anything in Owen that supported that notion.

[00:03:23] Speaker 03:
And one example of a way to support that notion would be

[00:03:27] Speaker 03:
some record of data showing when the patient was prompted.

[00:03:34] Speaker 00:
That's correct, Your Honor.

[00:03:35] Speaker 00:
And the time that the instruction is given is one of the pieces of data that is stored and transmitted in the O in reference, which we've pointed out in our briefs.

[00:03:44] Speaker 00:
But to the point, even without respect to the time that the instruction is given to the patient,

[00:03:53] Speaker 00:
The thing that's important to remember here is the disclosure in Owen is all about pushing the button in response to an instruction to do so.

[00:04:00] Speaker 00:
Now why is that what Owen teaches?

[00:04:03] Speaker 00:
Owen teaches that because the device itself is trying to decide whether or not this patient should get a shock or not.

[00:04:10] Speaker 00:
And the claim construction is whether the construction of patient compliance data is data indicating whether a patient has followed instructions for use.

[00:04:20] Speaker 00:
Now, the Owen reference does teach storing enough data to determine whether or not that button push was in response to an instruction, because that's how the device knows whether or not to shock.

[00:04:32] Speaker 01:
So I submit to you, Your Honor, that the disclosure... But you can push the button accidentally, right?

[00:04:38] Speaker 00:
You can push the button accidentally, and for purposes of deciding whether or not Owen anticipates

[00:04:43] Speaker 00:
Those aberrant button pushes are really not relevant.

[00:04:46] Speaker 00:
What is relevant here is the disclosure in Owen of pushing the button to stop a shock.

[00:04:51] Speaker 00:
The device does store data to determine whether or not, number one, an instruction, please respond as given.

[00:04:59] Speaker 03:
But if the board saw that your argument was based solely on the recording of button presses, then there's a question as to,

[00:05:12] Speaker 03:
That's kind of in a vacuum, right?

[00:05:13] Speaker 03:
And then they don't know if they can't tell just from that teaching alone whether it was in response to an instruction to press the button as opposed to the patient unilaterally electing to press that button, perhaps accidentally or for some other purpose, right?

[00:05:29] Speaker 00:
Right.

[00:05:30] Speaker 00:
Disclosure of any embodiment that anticipates anticipates.

[00:05:33] Speaker 00:
It is irrelevant if there are other aspects of O in that do not anticipate.

[00:05:37] Speaker 00:
And an aberrant button push might not anticipate.

[00:05:40] Speaker 00:
But a disclosure of a button push in response to an instruction to do so is patient compliance data.

[00:05:46] Speaker 00:
And that data is stored and transmitted.

[00:05:48] Speaker 00:
And where that comes from, and the fact that we've argued this throughout, even to the board, is the O and disclosure.

[00:05:53] Speaker 00:
The principle to O and disclosure is that in response, excuse me, in operation, the response button is pushed in response to EG, a quote, please respond verbal message

[00:06:06] Speaker 00:
This is the important part, so as to confirm patient consciousness or not.

[00:06:11] Speaker 00:
The device is storing data that tells whether or not the button push is in response to an instruction such that a shock should not be delivered.

[00:06:21] Speaker 00:
That's the critical thing here.

[00:06:22] Speaker 00:
And Your Honor, I think Dr. Efimov argued that in his deposition, that the whole point of the button push in response to an instruction to do show is so that the device doesn't shock.

[00:06:32] Speaker 00:
And the same thing, Dr. Gropper also explained that the button push

[00:06:35] Speaker 00:
was in response to an instruction.

[00:06:37] Speaker 00:
And because it's in response to an instruction, the device won't shock.

[00:06:42] Speaker 00:
So what we do know from the disclosure of Owen is number one.

[00:06:44] Speaker 03:
I guess the point is if a doctor at some point down the road was looking at the medical records of a patient and all that was stored was data about when a patient pressed a button, I guess for the board, they said that wasn't enough, that you needed to give some context to

[00:07:02] Speaker 00:
Right.

[00:07:03] Speaker 03:
Why the button was pressed at this particular time and that particular time.

[00:07:07] Speaker 00:
I'll give you two answers to that, Your Honor.

[00:07:08] Speaker 00:
Number one, the claim doesn't talk about an adopter down the line using the data that's stored to determine compliance.

[00:07:15] Speaker 00:
The claim simply requires that there be data to determine compliance.

[00:07:19] Speaker 00:
And the other thing that we know is that Owen does disclose, number one, the delivery of a message, please respond.

[00:07:25] Speaker 00:
The timing of the delivery of the message, please respond.

[00:07:28] Speaker 00:
The time the button, whether the button is pushed

[00:07:31] Speaker 00:
in response to that message and the time.

[00:07:34] Speaker 00:
So we do know that pursuant to the board's original construction, just data indicating whether or not the patient is complying with an instruction.

[00:07:45] Speaker 03:
You cited some things in Owen that are interesting that maybe, in fact, do teach that Owen also discloses recording

[00:07:55] Speaker 03:
buzzer prompts and when the buzzer prompts occur.

[00:07:59] Speaker 03:
But I guess the other side is saying that particular argument was waived.

[00:08:05] Speaker 03:
Do you agree with that?

[00:08:07] Speaker 00:
Absolutely not, Your Honor.

[00:08:08] Speaker 00:
And the reason is that on the institution decision, the board construed the term patient compliance data to mean data indicating whether or not a patient has complied with instructions for use.

[00:08:19] Speaker 00:
And on the institution decision, the board, when applying that construction to the own reference,

[00:08:25] Speaker 00:
added additional limitations, the time at which the instruction was given.

[00:08:29] Speaker 00:
Respironics had no reason to point to the board the disclosure in Owen at the time that the instruction was given was disclosed in Owen until the board added that limitation in its final written decision.

[00:08:41] Speaker 01:
And separate and apart from that, I- What prompted this change?

[00:08:46] Speaker 01:
Obviously, the board determined its construction one way at the point of initiation.

[00:08:53] Speaker 01:
And another way, at the point of the final decision, can you point to what occurred?

[00:08:58] Speaker 00:
Yes, Your Honor.

[00:08:59] Speaker 00:
Actually, it was very creative luring on the part of appellees.

[00:09:02] Speaker 00:
And what I mean by that is the disclosure of Owen did not change.

[00:09:06] Speaker 00:
And the construction, as articulated by the board, did not change, data indicating whether a patient has followed instructions for use.

[00:09:13] Speaker 00:
On the institution decision, the board found that, in and of itself,

[00:09:16] Speaker 00:
that the patient pushed the response button, that Owen discloses pushing the response button in response to an instruction to do that was patient compliance data.

[00:09:26] Speaker 00:
What happened was during depositions and at oral argument, in fact, at oral argument for the very first time, Zoll's counsel argued that that button push in response to an instruction to do so can't be that without some assurance that it wasn't some other kind of button push, that it wasn't one of those aberrant button pushes.

[00:09:46] Speaker 00:
Well, the reason I say that's creative lawyering is because what's important here is whether or not Owen does disclose some embodiment that anticipates.

[00:09:54] Speaker 00:
And it's the embodiment that the board was focused on in its institution decision, namely pushing the button in response to an instruction to do so that does show by proponents of the evidence that Owen anticipates the properly construed claim.

[00:10:13] Speaker 03:
What about the recommended wear time?

[00:10:15] Speaker 03:
That's another alternative that the board rejected.

[00:10:20] Speaker 00:
Yes, Your Honor.

[00:10:20] Speaker 00:
And the board rejected that one because on the theory that the message that we point to in the Owen reference, the Owen reference says that the device will give an indication to the wearer by a visual message and also a verbal prompt that you've been wearing the device greater than the recommended period of time.

[00:10:41] Speaker 00:
We say that's patient compliance data that is stored and transmitted.

[00:10:45] Speaker 00:
Owen says it's data that's stored and transmitted.

[00:10:48] Speaker 00:
And it is patient compliance data within the meaning of the board's definition of data indicating whether a patient has followed instructions for use.

[00:10:55] Speaker 00:
The board's analysis there added an additional limitation of basically that the instruction of how long to wear the device has to be given to the patient.

[00:11:06] Speaker 00:
And because Owen didn't disclose that the instruction was given to the patient,

[00:11:10] Speaker 00:
The board found there was no patient compliance data using that aspect of the O-in disclosure.

[00:11:16] Speaker 00:
Now, Your Honor, I submit to you that that is incorrect, because even the 003 patent doesn't talk about disclosing to the patient what the recommended wear time is.

[00:11:27] Speaker 00:
So again, we're talking about the proper construction, which the board articulated, data indicating whether the patient has followed instructions for use

[00:11:36] Speaker 00:
is satisfied by the Owen reference, both.

[00:11:38] Speaker 01:
So under the board's construction, the 003 patent could not infringe itself.

[00:11:44] Speaker 00:
Exactly.

[00:11:44] Speaker 00:
That's right.

[00:11:46] Speaker 00:
Under the board's morphed construction, the construction as applied by the board, which is to say that there must be some disclosure that the instruction of how long to wear the device was actually given to the patient.

[00:11:58] Speaker 00:
That's not disclosed in Owen.

[00:12:02] Speaker 00:
Your Honor, I'd like to turn to the issue of

[00:12:06] Speaker 00:
reversal versus remand, if I may.

[00:12:08] Speaker 00:
And there, Your Honor, we are, in fact, asking for a reversal.

[00:12:13] Speaker 00:
And I think the basis for a reversal instead of a remand is, actually, I think that this court's recent decision in the Belton versus Birktek case is quite instructive in this regard.

[00:12:29] Speaker 00:
And why is it that I think that you can reverse based on the record that you have in front of you?

[00:12:34] Speaker 00:
And there are several things.

[00:12:36] Speaker 00:
First of all, the board did make findings of fact in this institution decision that bear on whether or not all these other claim limitations are met, like, for example, storing and transmitting and that sort of thing.

[00:12:47] Speaker 00:
And also, in connection with deciding that the claim one was anticipated, the board found that each and every element of claim one is satisfied by the O in reference.

[00:12:58] Speaker 00:
So you have, excuse me, and also in the final written description, there's a summary of the Owen reference.

[00:13:04] Speaker 00:
And the summary of the Owen reference, which spans from A9 to A11 in the record, actually is a recitation of the disclosures in the Owen reference.

[00:13:12] Speaker 00:
Now, separate and apart from that, there is the institution decision.

[00:13:15] Speaker 00:
In the institution decision, the board did adopt means plus function definitions, or the proposed constructions that were offered by Respironics.

[00:13:25] Speaker 00:
And in the final written decision, the board didn't

[00:13:28] Speaker 00:
vacate those definitions or constructions.

[00:13:31] Speaker 00:
They basically said the constructions of those terms are not material to this decision.

[00:13:36] Speaker 00:
So there are means plus function and claim construction definitions.

[00:13:40] Speaker 01:
So why shouldn't we remand to have the board consider those at the first instance?

[00:13:45] Speaker 00:
You could do that, Your Honor.

[00:13:46] Speaker 00:
I'm also suggesting that there's enough here in the record to reverse.

[00:13:50] Speaker 00:
And in the Belton decision, it's exemplary.

[00:13:53] Speaker 00:
This court looked to the reference itself.

[00:13:56] Speaker 00:
to the decision to institute, to other findings that were in the final written decision, basically with respect to claims that were found obvious, to the claims that were reversed.

[00:14:08] Speaker 00:
Excuse me, the claims that were canceled.

[00:14:10] Speaker 01:
You're willing to your rebuttal time.

[00:14:12] Speaker 00:
Oh, I'm so sorry.

[00:14:13] Speaker 00:
I will rest, Your Honor.

[00:14:14] Speaker 00:
Thank you for giving me that heads up.

[00:14:16] Speaker 01:
All right, thank you.

[00:14:19] Speaker 01:
Mr. Bernholz.

[00:14:23] Speaker 02:
May it please the court, Richard Bernholz of IRL and Manila for Zoll.

[00:14:30] Speaker 02:
I'll start where they left off.

[00:14:35] Speaker 01:
Why don't you start with the morph argument?

[00:14:38] Speaker 02:
Sure.

[00:14:39] Speaker 02:
There's no morphing of claim construction.

[00:14:42] Speaker 02:
The standard of review in this case is substantial evidence, whether the finding of no anticipation is supported by substantial evidence.

[00:14:49] Speaker 02:
It is, and the board's decision should be, affirmed.

[00:14:53] Speaker 02:
In terms of the claim construction, during the board proceedings, Respironics presented slides that said Respironics does not dispute the claim construction.

[00:15:03] Speaker 02:
On appeal, Respironics is represented that they're not.

[00:15:06] Speaker 01:
Let's say claim construction, we're looking at substantial evidence.

[00:15:10] Speaker 01:
What about the application of a claim construction?

[00:15:13] Speaker 02:
So that's exactly the substantial evidence standard, because what we have here is you have a claim construction that's not disputed.

[00:15:20] Speaker 02:
And when you look at the cases that were cited by

[00:15:23] Speaker 02:
appellant, the cases where they say there's an issue of the application of the claim construction.

[00:15:28] Speaker 02:
When you look at those cases, they're appeals from district court decisions involving grants of summary judgment in which claim construction was disputed.

[00:15:36] Speaker 02:
So there's a de novo standard of review for claim construction and a de novo standard of review for the summary judgment.

[00:15:43] Speaker 02:
The entire appeal is governed by a de novo standard of review.

[00:15:46] Speaker 02:
Here, the appeal is governed by substantial evidence standard, whether the finding of no anticipation is supported.

[00:15:53] Speaker 03:
Well what if hypothetically we have a claim construction on the books and everybody's happy with it and then when it comes to the main event applying it what one could see is perhaps a meta-construction where now there's a construction of the construction and then that is used to figure out whether or not a reference teaches all those

[00:16:17] Speaker 03:
terms in the construction of the construction.

[00:16:20] Speaker 03:
In a situation like that, wouldn't you say, OK, maybe that's a claim construction issue?

[00:16:24] Speaker 02:
So I think you need to look at the nature of the party's dispute.

[00:16:27] Speaker 02:
And here what's happening is the other side is trying to transform a substantial evidence inquiry into a claim construction issue when there really isn't a claim construction issue.

[00:16:37] Speaker 02:
And in the Abbott case, which was cited by Appellants, there was a express morphed construction where

[00:16:46] Speaker 02:
The claim term required something to be substantially fixed.

[00:16:50] Speaker 02:
The construction was that it allowed for some movement.

[00:16:54] Speaker 02:
And then in applying that construction, what the court said is, I'm going to look for whether something is somewhat restrained.

[00:17:02] Speaker 02:
So it expressly changed its construction.

[00:17:06] Speaker 02:
Nothing like that happened here in the board's decision.

[00:17:08] Speaker 02:
And the board was very careful to say, we're applying.

[00:17:11] Speaker 01:
If we find that the board added a limitation,

[00:17:13] Speaker 01:
in between its initiation and its final decision.

[00:17:20] Speaker 01:
Wouldn't that be something similar to what you just described?

[00:17:23] Speaker 02:
In this case, the board consistently looked for context, the indicia of patient compliance.

[00:17:34] Speaker 02:
Was what was disclosed in Owen sufficient to teach someone of skill in the art whether there was patient compliance data

[00:17:42] Speaker 02:
from these button pushes or from the visual indicator about this expiration of the connection between the harness and the defibrillator, sort of like a sell-by date flashing on you.

[00:17:56] Speaker 02:
The date is now up, but it doesn't indicate anything about what the patient actually did.

[00:18:01] Speaker 02:
And the board consistently looked at indicia of compliance and the context of the disclosure of Owen.

[00:18:09] Speaker 02:
add limitations or read in limitations.

[00:18:11] Speaker 02:
So you have to look at the disclosure.

[00:18:14] Speaker 02:
They're arguing that a button push, a disembodied button push, is patient compliance data.

[00:18:19] Speaker 02:
The board said, I need to know what that data is.

[00:18:22] Speaker 02:
And in looking at the disclosure in Owen, in that context, it said, it's just a button push.

[00:18:28] Speaker 01:
Wouldn't you say that perhaps the board added a specific intent type limitation to the claim, to the construction?

[00:18:39] Speaker 02:
I would say no, absolutely not.

[00:18:41] Speaker 01:
Then why is there a difference between whether the button was pushed purposely or inadvertently?

[00:18:49] Speaker 02:
So the data must indicate patient compliance.

[00:18:54] Speaker 02:
And the data concerning whether the button was pushed without tying it to a prompt or an instruction leaves no information to the person looking at that data.

[00:19:08] Speaker 01:
So you have information that the button was pushed.

[00:19:12] Speaker 01:
So it's not that there's no information.

[00:19:15] Speaker 01:
You do have information.

[00:19:16] Speaker 01:
You have information that the button was pushed.

[00:19:19] Speaker 01:
Your problem with that information is you can't tell whether it was pushed inadvertently or not.

[00:19:24] Speaker 02:
That's right.

[00:19:24] Speaker 02:
It's just undifferentiated data.

[00:19:26] Speaker 01:
When has it had a specific intent limitation?

[00:19:28] Speaker 01:
Aren't you putting a limitation on a patient as to when, whether they desired, intended to push a button or not?

[00:19:36] Speaker 02:
I'm looking at the quality and character of the data that's transmitted.

[00:19:41] Speaker 02:
And what you have here is just an undifferentiated button push.

[00:19:44] Speaker 01:
And when you look at the purpose... But that's not the quality of the data.

[00:19:48] Speaker 01:
That's not in the claim construction.

[00:19:51] Speaker 01:
That's not in the claim.

[00:19:52] Speaker 01:
It's just the transmission of data.

[00:19:56] Speaker 02:
The claim requires data indicating that a patient followed instructions for use.

[00:20:01] Speaker 02:
And so there has to be some

[00:20:03] Speaker 02:
think about the data that connects the information with the instruction?

[00:20:08] Speaker 03:
I guess we have a philosophical inquiry here.

[00:20:10] Speaker 03:
It's like, how do we understand, from which perspective are we supposed to look at this data?

[00:20:15] Speaker 03:
If we're looking at the data from the perspective of someone that reads this data three months later and is trying to figure out what does the data mean, then maybe you have a point.

[00:20:27] Speaker 03:
If we look at it from the perspective of the patient,

[00:20:30] Speaker 03:
the patient knows that it was complying with that data and maybe even by whoever the prompter is.

[00:20:37] Speaker 03:
The prompter will have a record of that button push at that time in response to the prompt.

[00:20:44] Speaker 03:
So we have to understand, all right, from which perspective are we supposed to understand the data in terms of patient compliance data.

[00:20:54] Speaker 03:
The patient is complying with a

[00:20:57] Speaker 03:
with a prompt.

[00:20:59] Speaker 02:
I mean, that's what the embodiment is talking about in O. So I understand the philosophical nature of the question, but what we have to do is look at what is at issue.

[00:21:12] Speaker 02:
We have medical devices that have been prescribed for certain treatment.

[00:21:15] Speaker 02:
People in this field understand what the term patient compliance data

[00:21:21] Speaker 02:
refers to, and it refers to data indicating that the patient has followed instructions as the board construed it, and a push of a button in this instance to disarm the device, which is what it's used for.

[00:21:36] Speaker 02:
It says you're about to get shocked if there's a cardiac event or the device is malfunctioning.

[00:21:43] Speaker 02:
It gives you a warning, and it's like a panic button.

[00:21:47] Speaker 02:
And so pushing the button

[00:21:50] Speaker 02:
is at most indicative of using the device.

[00:21:53] Speaker 02:
And the construction that the other side proposed to the board was that compliance data was anything relating to use of the device.

[00:22:01] Speaker 02:
And the board rejected that, because that construction does not put significant weight on the word compliance.

[00:22:07] Speaker 02:
And so Mr. Gropper, in his declaration, said a person of skill in the art would not understand the button push, which just indicates whether the button was pushed,

[00:22:19] Speaker 02:
as patient compliance data.

[00:22:21] Speaker 03:
What about the fact that Owen does seem to teach recording the buzzer prompts and storing the time when those buzzer prompts occur?

[00:22:36] Speaker 02:
So there is a reference in Owen that says... Memory block 57.

[00:22:42] Speaker 03:
It does a lot of different things, including these things.

[00:22:45] Speaker 02:
So there is no

[00:22:49] Speaker 02:
I would say that there is no specific disclosure of storing the time of the prompt.

[00:22:54] Speaker 02:
The prompt may be stored.

[00:22:56] Speaker 02:
There is a line in Owen that says, voice, tone, and buzzer prompts may end up in the memory logging block.

[00:23:03] Speaker 02:
But the discussion about a time log, which was never raised at all before the board.

[00:23:08] Speaker 02:
This is the waiver question that your honor asked.

[00:23:14] Speaker 02:
Respiron has conceded that it never argued to the board

[00:23:17] Speaker 02:
the time of the prompt being stored in Owen.

[00:23:21] Speaker 02:
And there's nothing in Owen, even taking that argument at its face value, there's nothing connecting the time disclosure to those prompts.

[00:23:31] Speaker 02:
It's just a general statement that a time of an event may be a part of the log.

[00:23:38] Speaker 02:
But when you look at the disclosure in that paragraph of Owen, which was never cited below to the board as patient compliance data,

[00:23:47] Speaker 02:
When you look at that, there's nothing connecting it to the prompts.

[00:23:52] Speaker 02:
It's actually talking about data that's sent to and from the defibrillator, not internal operations of the defibrillator.

[00:24:01] Speaker 02:
So this is an anticipation case.

[00:24:03] Speaker 02:
And so from an anticipation standpoint, referring to that abstract statement is not sufficient.

[00:24:10] Speaker 02:
Plus, it was never submitted to the board.

[00:24:11] Speaker 02:
And opposing counsel conceded in their rehearing petition to the board.

[00:24:16] Speaker 02:
that this issue was not raised.

[00:24:18] Speaker 02:
The argument that was made in opening today that, well, this was clever lawyering, and this just came up by Zoll, I think that's a complete red herring argument, because this is an anticipation case, and it's appellant's burden of proof to show anticipation.

[00:24:34] Speaker 02:
And the original petition did not even mention the button press.

[00:24:38] Speaker 02:
It did not mention the visual indicator about this expiration

[00:24:44] Speaker 02:
time between the connection with the electrodes and the harness.

[00:24:49] Speaker 02:
So there's no way to fault our side for raising arguments that show that there has not been a showing that the button press or the visual indicator are patient compliance data.

[00:25:04] Speaker 02:
The one point that was made in opening about, well, anticipation some of the time is still anticipation.

[00:25:13] Speaker 02:
If there's one embodiment that anticipates, then that's enough.

[00:25:17] Speaker 02:
And what the board found, and correctly so, was that there were no embodiments that met the patient compliance data limitations.

[00:25:29] Speaker 02:
That the button press was just undifferentiated data, and there was no context around that.

[00:25:34] Speaker 02:
And the visual indicator that that

[00:25:38] Speaker 02:
did not reflect compliance with anything.

[00:25:40] Speaker 02:
And Respironics has conceded that the data about the time the harness was connected to the defibrillator is not related to the amount of time the patient has actually worn the device.

[00:25:55] Speaker 02:
So it's indicative of nothing.

[00:25:57] Speaker 02:
It's like a warning light coming on in your car that says three months have elapsed since you last changed your oil.

[00:26:02] Speaker 02:
But it doesn't say whether you changed your oil, whether you noticed the light,

[00:26:06] Speaker 02:
or anything that actually was done in connection with your car.

[00:26:10] Speaker 02:
Same thing.

[00:26:11] Speaker 02:
It's like a sell-by date for the milk in your refrigerator.

[00:26:13] Speaker 02:
You don't know.

[00:26:14] Speaker 03:
I'm just curious.

[00:26:15] Speaker 03:
Why wouldn't the phrase recommended wear time just inherently mean that the patient has been informed somehow, some way?

[00:26:28] Speaker 03:
It's been communicated to the patient how long the wear time is for.

[00:26:32] Speaker 02:
So in this context, first the board specifically found that the argument about recommended was not made during the

[00:26:40] Speaker 02:
IPR proceedings and so it declined to address it for that reason although it said even so there's no disclosure or no evidence that a person of skill in the art would understand recommended to mean recommended to the patient as opposed to the the concept that these electrodes have a certain life it's basically they did and that's what happens they deteriorate and so what in the device you connect the

[00:27:08] Speaker 02:
the electrode harness to the defibrillator, and then there's a countdown that starts, whether you wear it or not.

[00:27:15] Speaker 01:
Is it the case that the longer the patient wears it, the greater the deterioration?

[00:27:21] Speaker 02:
It's the longer that the, it's connected to the, in Owen, it's how long the electrodes are connected, the electrode harness is connected to the defibrillator.

[00:27:32] Speaker 02:
It's not necessarily connected to how long the patient wears it.

[00:27:37] Speaker 02:
Your hypothetical question is, are they going to deteriorate longer if you wear it longer?

[00:27:43] Speaker 02:
I'll say yes.

[00:27:43] Speaker 02:
I mean, that's the nature of the material that they deteriorate after a certain amount of time.

[00:27:47] Speaker 01:
If that information, then, is transmitted from the device back to a doctor, that the patient has been wearing this for X amount of hours, and that amount of time is above the recommended time of use,

[00:28:01] Speaker 01:
Why does it matter whether the patient knows that or not?

[00:28:04] Speaker 01:
I mean, you have patient data that's been communicated.

[00:28:07] Speaker 02:
There is no information about the patient wearing the device.

[00:28:12] Speaker 02:
It's literally a countdown for how long the electrode harness has been connected to the defibrillator.

[00:28:18] Speaker 02:
And Respironics' expert has conceded that it's not related to the amount of time that the patient wears the device, that there's nothing

[00:28:29] Speaker 02:
relating to this indicator that the indicator does not have any relation to the patient actually wearing the device.

[00:28:38] Speaker 02:
It's literally the result of a countdown.

[00:28:48] Speaker 02:
The light comes on after a certain amount of time, and it doesn't provide any information to a caregiver about how long the patient has actually been wearing the device.

[00:28:58] Speaker 02:
clear from the record.

[00:29:02] Speaker 02:
So unless there are further questions, thank you.

[00:29:05] Speaker 01:
Mr. Franco, you have three minutes.

[00:29:09] Speaker 00:
Your Honors, I'd like to just make one point in connection with each of the two different disclosures in the Owen reference.

[00:29:14] Speaker 00:
First of all, Your Honor, Judge Chen, in response to your question or your comment that it seems that it's important from whose perspective are you looking for compliance?

[00:29:21] Speaker 00:
Is it the physician down the line?

[00:29:23] Speaker 00:
Is it the patient themselves?

[00:29:25] Speaker 00:
I'd submit to you, Your Honor, that the answer is

[00:29:27] Speaker 00:
the data itself, does the data indicate that a button push was in response to a message to do so?

[00:29:33] Speaker 00:
And what we know from the Owen disclosure is that the data will tell us whether or not the push was in response to instruction to do so.

[00:29:41] Speaker 00:
So Owen, the data does indicate patient compliance because it does store enough information to determine whether any given button push was in response to an instruction to do so.

[00:29:51] Speaker 03:
Why is that so?

[00:29:53] Speaker 03:
that the data stored is sufficient enough to indicate that it was in response to an instruction to do that?

[00:30:01] Speaker 00:
Well, because the data stores whether or not a message was given, what the message was, please respond, when it was given, if the patient pushed the response button, and the time at which the response button was submitted.

[00:30:14] Speaker 03:
So where does the ON reference say all of that?

[00:30:17] Speaker 00:
We've cited all the different parts in our brief, Your Honor, where Owen discloses the time at which a message is given, the time at which a button is pushed in response, and the data will also indicate whether or not a shock was given.

[00:30:33] Speaker 00:
So the device itself knows whether or not the patient complied with the instruction to push the button.

[00:30:39] Speaker 00:
And the device keeps track.

[00:30:40] Speaker 00:
Was the shock given?

[00:30:40] Speaker 00:
Was the shock not given?

[00:30:42] Speaker 00:
If the shock wasn't given, that data indicates that the patient complied with the instruction

[00:30:47] Speaker 00:
to push the response button.

[00:30:49] Speaker 00:
So it's the data that tells whether or not the patient complied.

[00:30:52] Speaker 00:
And it's the disclosure in Owen that there can be such compliance, that the patient can respond to instruction to do so that's important here.

[00:31:01] Speaker 00:
Owen discloses the fact that there is patient compliance data that's stored and transmitted.

[00:31:08] Speaker 03:
Because there's also data on whether there was a shock given

[00:31:13] Speaker 00:
That's part of it.

[00:31:14] Speaker 00:
I think even if there's no data on whether or not the shock is given, the device keeps track.

[00:31:20] Speaker 00:
Even under the board's morphed construction that you have to disclose the message, the time that the message was given, Owen undoubtedly discloses when the message is given to the patient, when the patient responds.

[00:31:34] Speaker 00:
In fact, Owen discloses a whole training protocol so that the device can kind of learn how quickly this patient responds to a message.

[00:31:41] Speaker 00:
So we know that the device

[00:31:42] Speaker 00:
stores when the message is given, when the patient responds.

[00:31:46] Speaker 00:
In fact, it stores what the response time is over a repeated training protocol.

[00:31:51] Speaker 00:
That's all that even the board's morphed construction requires.

[00:31:54] Speaker 00:
So if I may turn to the recommended wear time, I think.

[00:31:59] Speaker 01:
Very briefly, OK?

[00:32:00] Speaker 01:
You're almost out of your time.

[00:32:01] Speaker 00:
OK, thank you, Your Honor.

[00:32:03] Speaker 00:
The moment the message is given to the patient that you've exceeded the recommended wear time, number one, the instruction is given to the patient, and number two,

[00:32:13] Speaker 00:
there is information about compliance.

[00:32:16] Speaker 00:
The data, excuse me, the device is then storing the fact that the patient hasn't complied with the wear time instruction.

[00:32:22] Speaker 00:
Thank you, Your Honor.

[00:32:23] Speaker 01:
Thank you very much.