[00:00:00] Speaker 04:
15-1149 LifeScan Scotland Limited versus Pharmatech Solutions, Inc.

[00:00:06] Speaker 04:
Ms.

[00:00:06] Speaker 04:
Eldy.

[00:00:08] Speaker 05:
Good morning and may it please the court.

[00:00:10] Speaker 05:
The 105 patent at issue in the IPR covers the operation of the market leading home-plugged glucose monitor.

[00:00:17] Speaker 05:
And the board's decision finding all three claims of that patent invalid

[00:00:21] Speaker 05:
illustrates the dangers of disregarding the legal safeguards against use of hindsight and an obvious misdetermination.

[00:00:28] Speaker 04:
Well, let's take the combination of Winota and Schulman.

[00:00:35] Speaker 04:
Yes.

[00:00:38] Speaker 04:
Winota shows a reference electrode, which is upstream of two working electrodes according to the board.

[00:00:50] Speaker 04:
And they found that there would be a motivation to combine that with Schulman.

[00:00:54] Speaker 04:
So what's wrong with that?

[00:00:56] Speaker 04:
Why isn't that supported by substantial evidence?

[00:00:59] Speaker 05:
There are at least two reasons.

[00:01:00] Speaker 05:
First of all, with respect to the board's finding about Winarta, there's no dispute.

[00:01:04] Speaker 05:
In fact, the board and Pharmatech agree that Winarta does not disclose two working electrodes.

[00:01:12] Speaker 05:
According to the 105 patent claims, there have to be two working electrodes.

[00:01:16] Speaker 05:
They're called sensors in the claims.

[00:01:17] Speaker 04:
Yeah, but the board found that it would have been within the skill of someone in the art to turn the other electrode into a working electrode.

[00:01:28] Speaker 05:
They said it would have been capable of being used in that regard and could have been turned into that.

[00:01:34] Speaker 05:
And there was absolutely no evidentiary basis for the board's finding in that regard.

[00:01:39] Speaker 05:
The only evidence of what one skilled... Well, frankly, there was no evidence presented by Pharmatech about how one of ordinary skill in the art at the time of invention would have read Winarta, because its only declaration evidence was from Dr. Wang, who did not even address what the level of ordinary skill in the art was.

[00:01:57] Speaker 05:
And he certainly did not address any of his statements or his conclusions about the prior art from the context of one of ordinary skill at the time of the invention.

[00:02:09] Speaker 04:
doesn't produce the invention because there's a second working electrode missing.

[00:02:15] Speaker 04:
Is there any other argument?

[00:02:17] Speaker 05:
Well, that's one reason, that when NARTA does not disclose the strip elements of the claims, the other argument is that there's no evidence of motivation to combine.

[00:02:27] Speaker 05:
The only evidence, again, we have Dr. Wang's declaration testimony not based or viewed from the prism of one of ordinary skill in the art at the time of the invention,

[00:02:37] Speaker 05:
The only statement in that declaration that Pharmatech or the board can point to as motivation for combining Winarta or Nankai with Schulman is an 18-word statement that use of a known technique to improve similar devices in the same way and the results would be predictable.

[00:02:56] Speaker 05:
That's the only thing they can point to.

[00:02:58] Speaker 02:
Is it your position that the board couldn't look at the two references and find motivation within the references themselves?

[00:03:04] Speaker 05:
Not on this record, Your Honor.

[00:03:06] Speaker 05:
This is not an examination proceeding.

[00:03:08] Speaker 05:
It was an adjudicative proceeding.

[00:03:10] Speaker 05:
And Pharmatech had a burden of proof, a burden of coming forward with evidence that would show by preponderance of the evidence that this invention was obvious, that one skill in the art would have looked at these references and come to this conclusion.

[00:03:23] Speaker 02:
What if we think that it's OK to submit the act of submitting the very references that supply the motivation would be enough?

[00:03:32] Speaker 05:
Well, in this case,

[00:03:34] Speaker 05:
They are not enough.

[00:03:35] Speaker 05:
And there may be cases, Your Honor, where that would be enough.

[00:03:37] Speaker 04:
But the reason motivation... We just decided a case called Belden, in which we approved that.

[00:03:42] Speaker 04:
You're familiar with the case?

[00:03:43] Speaker 05:
I am, Your Honor.

[00:03:45] Speaker 04:
This case is you... This case... But isn't my description of Belden's accurate, isn't it?

[00:03:50] Speaker 05:
Well, in this case, the motivation... Well, answer my question.

[00:03:53] Speaker 05:
I'm sorry, Your Honor.

[00:03:54] Speaker 04:
Isn't my description of Belden accurate, where we approve the board's reliance on the references?

[00:04:00] Speaker 05:
In that particular case, yes, Your Honor.

[00:04:03] Speaker 05:
In this case, the reason that evidence of motivation to combine is so critical, again, to avoid use of hindsight, is this is not a case where you could just pluck from one reference one element of the claim, pluck from another reference an element of the claim, and put them together, and you have the claimed invention.

[00:04:20] Speaker 05:
You first had to look at each of the references and modify each of them.

[00:04:23] Speaker 05:
You had to modify Nankai to come up with the strip elements of the claims.

[00:04:28] Speaker 05:
You had to modify Winarta to come up with the strip elements of the claims.

[00:04:33] Speaker 05:
You had to modify Schulman.

[00:04:35] Speaker 05:
You had to have some reason why somebody skilled in the art would have looked to Schulman to an instance where you have implanted blood sensors that are awash with blood and would have looked to that and have thought to combine anything from Schulman with these other patents that relate to disposable test strips to which small amounts of blood are applied.

[00:04:58] Speaker 05:
And there was no evidence of the record here.

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And I would submit that based on these references,

[00:05:02] Speaker 05:
It was not enough for the board to go in and make its own findings about what somebody skilled in the art at the time would have thought of these references, or that one skilled in the art would have been motivated to combine these references.

[00:05:16] Speaker 03:
But you said you had to modify NAMCAI.

[00:05:18] Speaker 03:
The modification, though, there were not a broad range of possible modifications, correct?

[00:05:24] Speaker 05:
Well, there's argument to that effect.

[00:05:27] Speaker 05:
Obviously, Your Honor, there was not a broad range of modifications.

[00:05:31] Speaker 05:
but there's no evidence in the record that somebody skilled in the art would have found each of those potential modifications to be applicable or possible.

[00:05:40] Speaker 05:
It's not like one of the cases that Pharmatech relies upon and the board relied upon.

[00:05:45] Speaker 05:
One of the range cases like Inray, I think it was Woodruff,

[00:05:49] Speaker 05:
where you have a range, you have 36 to 74, and you have something within that range, and the argument was, or the holding was, unless you can show that there was something unexpectedly advantageous about that, it would be prima facie obvious.

[00:06:05] Speaker 05:
Well, that's not the case here.

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In the case of a range from 36 to 42, 72, I know what everything in that range is, and there's no reason to believe that they are distinguishable from one another because the prior art claims it.

[00:06:17] Speaker 04:
Here in Nankai, all we had is... You're suggesting the obviousness tri is limited to range situations?

[00:06:25] Speaker 05:
No, I'm not, Your Honor.

[00:06:27] Speaker 05:
I'm saying that the Woodruff holding that said that there had to be a showing of an advantage had to be showing to be unexpected in the context of

[00:06:38] Speaker 05:
an overlapping numerical range is not applicable to a situation like Nankai, where the only disclosure in Nankai was that the invention is not limited to what's shown in the figures.

[00:06:51] Speaker 05:
And from that, Pharmatech and the board takes, well, somebody skilled in the art would have modified Nankai to put the reference sensor upstream of the working sensors, even though all we have is a conclusory statement after the fact hindsight statement,

[00:07:08] Speaker 05:
from Pharmatech's expert to that effect.

[00:07:11] Speaker 05:
And even though there was substantial evidence presented by LifeScan through its expert, Dr. Smith, saying, you know, it's really critical to put the reference electrode upstream of the other electrode.

[00:07:21] Speaker 05:
And there's nothing in NANKAI to suggest that that's the case.

[00:07:24] Speaker 04:
But it is shown in Winarta.

[00:07:27] Speaker 05:
For one electrode.

[00:07:28] Speaker 05:
For one electrode.

[00:07:29] Speaker 04:
The reference electrode is upstream in Winarta, right?

[00:07:32] Speaker 05:
Yes.

[00:07:33] Speaker 05:
But the examiner did neither the board

[00:07:38] Speaker 05:
Nor Pharmatech espoused a combination of references of Nankai plus Winarta plus Schulman.

[00:07:43] Speaker 05:
So that's not a rejection that was made.

[00:07:46] Speaker 05:
That's not a rejection that was briefed here.

[00:07:49] Speaker 05:
The two rejections were Nankai plus Schulman and Winarta plus Schulman.

[00:07:53] Speaker 04:
And the thing that's missing from the Winarta-Schulman combination is, in your view, the second electra.

[00:08:00] Speaker 05:
The second electra.

[00:08:01] Speaker 05:
And any evidence

[00:08:02] Speaker 05:
that one skilled in the art would have made that modification.

[00:08:05] Speaker 05:
It's not enough to say they could have, but would they have done so?

[00:08:10] Speaker 05:
Because it's undisputed.

[00:08:11] Speaker 05:
They would have had to have made modifications to do so.

[00:08:15] Speaker 05:
It's undisputed.

[00:08:15] Speaker 05:
There would have had to have been made a modification.

[00:08:18] Speaker 04:
That's always the case when you combine prior art, that there have to be some modifications, right?

[00:08:23] Speaker 05:
No, I don't think it is always the case, Your Honor.

[00:08:25] Speaker 05:
I think sometimes in simple mechanical inventions you can take

[00:08:29] Speaker 05:
you know, an element from reference A and a relevant from reference B and put them together and there's the invention.

[00:08:34] Speaker 05:
But in a complex technology like this where it's an admittedly high level of skill of the art, bachelor's degrees in chemistry, electrical engineering and at least five years experience working with electrochemical sensors, something more is needed to justify or to support evidentially an obviousness rejection.

[00:08:59] Speaker 02:
Doesn't that very high level of skill in the art actually weigh against you under KSR and that it should be viewed from the skill of such a high level that it wouldn't have been?

[00:09:11] Speaker 02:
KSR says we got to use the common sense, the common sense level of one of ordinary skill in the art and their knowledge, not just discount that with respect to these modifications.

[00:09:22] Speaker 05:
Well, again,

[00:09:23] Speaker 05:
There's no evidence in this record of how somebody of that level of skill in the art would have viewed these.

[00:09:29] Speaker 05:
In fact, the evidence that is of record, the only evidence of record of anybody viewing this through the prism of one skilled in the art is in the Smith Declaration, which LifeScan submitted.

[00:09:40] Speaker 02:
What about the board?

[00:09:41] Speaker 02:
The board certainly in its determination was looking at it.

[00:09:44] Speaker 02:
They knew what the level of ordinary skill in the art was and adopted the level that you had suggested, right?

[00:09:51] Speaker 05:
They did.

[00:09:52] Speaker 05:
They did.

[00:09:52] Speaker 05:
There was no dispute about the level of skill.

[00:09:55] Speaker 05:
That's correct.

[00:09:57] Speaker 05:
But their findings, as we pointed out in our briefs, some of their findings are simply not supported by the evidence.

[00:10:04] Speaker 05:
For example, with respect to Winarda, they refer to several lines in Winarda saying that, well, the Winarda second electrode takes measurements.

[00:10:13] Speaker 05:
And what they refer to for that second electrode is reference in Winarda to it taking measurements of resistance, not a measurement

[00:10:22] Speaker 05:
of the concentration of a substance which is required at the second working electrode.

[00:10:27] Speaker 05:
So the board made findings that were simply not supported by the record.

[00:10:33] Speaker 04:
Okay.

[00:10:34] Speaker 04:
Thank you.

[00:10:34] Speaker 04:
Thank you.

[00:10:38] Speaker 04:
Mr. Schaffer.

[00:10:39] Speaker 01:
Thank you.

[00:10:39] Speaker 01:
May I please support John Schaffer on behalf of Pharmatech.

[00:10:42] Speaker 01:
First, to address this issue about Bonaerta and whether there's any record support for the second electrode.

[00:10:48] Speaker 03:
Can we talk about the

[00:10:50] Speaker 03:
bigger picture argument that's being made here, which is that whatever the result the board reached, it's not one that you led them to.

[00:10:59] Speaker 03:
The board did not really apply an appropriate standard of burden of proof for you.

[00:11:07] Speaker 03:
I mean, you did not submit an expert testimony.

[00:11:09] Speaker 03:
Dr. Wang, you pretty much concede that he doesn't mention the level of skill in the art.

[00:11:15] Speaker 03:
his sort of ipsy-dixit that you would have known without putting it into a time frame or talking about the level of skill in the art is clearly not enough under our case law.

[00:11:26] Speaker 03:
So you fall back on, well, it's not complex technology.

[00:11:29] Speaker 03:
So it's OK.

[00:11:31] Speaker 03:
But it is complex technology.

[00:11:33] Speaker 03:
And you didn't dispute that the level of skill in the art was high.

[00:11:36] Speaker 03:
So why don't we have a situation in which the board has stepped out of its role as an adjudicator who's supposed to

[00:11:44] Speaker 03:
to be looking at an adversary process and instead is becoming the adversary?

[00:11:50] Speaker 01:
First of all, there really was no dispute about skill in the art.

[00:11:53] Speaker 01:
And the issue of skill in the art should apply to various elements of the technology here.

[00:11:58] Speaker 01:
The issue we're looking at for skill of the art, and I think the focus here is on Nankai, is how you arrange three little blocks.

[00:12:06] Speaker 01:
You don't need to be highly skilled that there's only so many ways you can arrange

[00:12:10] Speaker 01:
reference electrode into working electrodes.

[00:12:14] Speaker 03:
But you concede that your expert testimony was inadequate on that point, right?

[00:12:20] Speaker 01:
On that point, no I don't.

[00:12:21] Speaker 01:
I don't consider it, they say it's conclusory

[00:12:23] Speaker 01:
because what Dr. Wang testified to is you can only arrange these things so many ways.

[00:12:29] Speaker 01:
I don't know what more evidence he would need to provide other than to say you have three blocks, you can arrange them that way, that way, that way, that way.

[00:12:38] Speaker 01:
There's really nothing else to say about how those blocks can be arranged.

[00:12:43] Speaker 03:
And you don't find it to be problematic that he doesn't refer to the level of skill in the art or put it into the appropriate timeframe?

[00:12:50] Speaker 01:
I know because there's really no dispute about the level of skill in the art in this context.

[00:12:56] Speaker 02:
The problem is how can you rely on his declaration when he hasn't, it's not clear that he had the right frame of mind when he did the analysis.

[00:13:09] Speaker 01:
I accept that.

[00:13:10] Speaker 01:
And my point there is, if we were talking about a complicated element of this technology, then you would have an argument there.

[00:13:17] Speaker 01:
If we're talking about how the reagent formula transfers glucose into electrons, then you have an argument there.

[00:13:24] Speaker 01:
But with respect to what's being discussed here on Nan Kai, you're simply talking about the arrangement of the reference electrode with the two working electrodes.

[00:13:33] Speaker 01:
That's all we're talking about here and that does not require any significant level of skill to know it can be arranged in one of three ways.

[00:13:41] Speaker 01:
Let me take that argument back a little bit because the argument was made that Woodruff doesn't apply to this instance because Woodruff only addresses ranges.

[00:13:51] Speaker 01:
And the argument here is that the arrangement, I think the argument you're coming to about the level of skill in the art, is that this was a critical arrangement.

[00:14:00] Speaker 01:
The specifications don't support that this is a critical arrangement at all.

[00:14:04] Speaker 01:
First of all, the specifications say you can arrange the working electrodes any way you want to, which would include a way to arrange it with respect to the reference electrode.

[00:14:13] Speaker 01:
Moreover, Woodruff says it talks about a range, but then it also talks about any other variable.

[00:14:20] Speaker 01:
How you arrange these three blocks is a variable.

[00:14:22] Speaker 01:
So you not only need to prove the criticality of this, you would need to prove that the result is unexpected.

[00:14:28] Speaker 01:
And I think it's important to look at the issue of criticality.

[00:14:31] Speaker 01:
Again, you look at what the specification says on this issue.

[00:14:34] Speaker 01:
The specification doesn't refer to it as critical.

[00:14:37] Speaker 01:
The specification simply refers to it as a preferred embodiment.

[00:14:40] Speaker 03:
But who's supposed to prove what when you're the one making the claim of obviousness?

[00:14:46] Speaker 03:
I mean, this is part of my problem.

[00:14:49] Speaker 03:
You had the burden.

[00:14:50] Speaker 03:
Yes.

[00:14:51] Speaker 03:
And you had the burden to show that it's obvious.

[00:14:52] Speaker 03:
Yes.

[00:14:53] Speaker 03:
You don't have expert testimony showing that it's obvious.

[00:14:56] Speaker 03:
So you have to fall back on the fact that this is simple.

[00:14:59] Speaker 03:
And therefore, anybody could do it.

[00:15:01] Speaker 03:
So we accept what the level of skill in the art is.

[00:15:04] Speaker 03:
And solely because there were a limited number of arrangements, that's your basis, your entire basis for your argument that it would have been obvious, right?

[00:15:14] Speaker 01:
There's two bases there.

[00:15:15] Speaker 01:
One is that there's a limited number of

[00:15:18] Speaker 01:
of options and the results would be expected.

[00:15:22] Speaker 01:
And the argument here that there was no motivation to combine any of these things, you want to promote and achieve accuracy, which is what we're talking about here.

[00:15:29] Speaker 04:
So how... What about, is the board entitled to look at the original prosecution here where the ordering of the electrodes was found not to be novel, to have been obvious over Winarta and Nankai?

[00:15:46] Speaker 04:
in rejecting any claim to the strips.

[00:15:52] Speaker 01:
Absolutely, and we made that argument, and what they're arguing is criticality.

[00:15:57] Speaker 01:
was not in the original application for this.

[00:15:59] Speaker 01:
The original application allowed any ordering.

[00:16:01] Speaker 01:
And only when Nankai was cited in prosecution did they come back and make an amendment to arrange in this particular order.

[00:16:09] Speaker 01:
And when you look at the specifications.

[00:16:11] Speaker 04:
And they didn't get the patent on the order.

[00:16:13] Speaker 01:
They didn't get a patent.

[00:16:15] Speaker 01:
They did not get a patent on the order in the strip.

[00:16:17] Speaker 01:
No.

[00:16:20] Speaker 01:
So that goes to that particular point about the ordering being obvious.

[00:16:26] Speaker 01:
And I think it's important this argument about criticality is not supported in the specification because the only advantage of this particular ordering would be in the very rare situation where both of the working electrodes are not covered completely in the exact same manner.

[00:16:47] Speaker 01:
Because if they're not, you're still going to get an error anyway.

[00:16:51] Speaker 01:
So this ordering is not necessarily significant.

[00:16:54] Speaker 01:
The argument that was also made that there was no evidence of a motivation to combine, motivation to combine is contained in all three of these patents.

[00:17:03] Speaker 01:
And I'm including the 105, which specifically says accuracy here is the motivation.

[00:17:12] Speaker 01:
Anything you can do to improve accuracy

[00:17:16] Speaker 01:
is a motivation with respect to these patents.

[00:17:19] Speaker 01:
So if we look first to the Nankai patent, in Nankai you have multiple measurements being taken and averaged.

[00:17:28] Speaker 01:
And Nankai specifically says that increases accuracy.

[00:17:32] Speaker 01:
That's all Schulman does is if you have multiple measurements, what are things you can do with multiple measurements?

[00:17:39] Speaker 01:
One thing you can do with multiple measurements is you can see if they're too different.

[00:17:44] Speaker 01:
And this argument that Schulman is somehow unique technology that someone would not be motivated to combine with a test strip doesn't make any sense because LifeScan before the district court specifically argued that this is what Schulman is teaching in terms of if you have two samples that you compare them to see if they're too far apart is well known, trivial, and known to everyone.

[00:18:10] Speaker 01:
And that's what the board found with respect to Schulman.

[00:18:13] Speaker 01:
We're not talking about Schulman for the purposes of anything unique it does with respect to implantable diabetic sensors.

[00:18:22] Speaker 01:
We're just talking for the basic proposition, which is, what do you do when you have two measurements?

[00:18:28] Speaker 01:
And that's specifically what the board found.

[00:18:30] Speaker 01:
And when LifeScan argues you need to look at a patent as a whole, that point is, you don't need to look at the specific invention.

[00:18:38] Speaker 01:
You need to look at everything the patent teaches.

[00:18:40] Speaker 01:
And what this patent teaches, what Schulman teaches, is if you are taking multiple measurements, you can average them, and that's going to get you a better result.

[00:18:49] Speaker 01:
But the other thing you can do is look at if they're too different.

[00:18:52] Speaker 01:
And why would you be motivated to combine that with Nan Kai?

[00:18:56] Speaker 01:
You already have the multiple measurements.

[00:18:58] Speaker 01:
You're going to be motivated because it increases accuracy, which is specifically what Dr. Wang said is what Nan Kai says, is what Linarda says.

[00:19:07] Speaker 01:
and is specifically what the 105 patent says is their motivation.

[00:19:11] Speaker 02:
Why are you looking to what the 105 patent says for motivation anyway?

[00:19:15] Speaker 01:
The only reason I'm looking at it is this argument that there was no motivation to combine.

[00:19:20] Speaker 01:
Yeah, but stick to the prior.

[00:19:22] Speaker 01:
The motivation to combine is contained in Nan, Kai, and Winarda, that you want to increase accuracy.

[00:19:30] Speaker 01:
And that is in Dr. Wang's declaration.

[00:19:32] Speaker 01:
He has his whole research article, review article, that he published.

[00:19:36] Speaker 01:
that is incorporated by reference that says that's the issue.

[00:19:39] Speaker 01:
Getting to this last issue of Winarda and the point Judge Dyke, you raised, which is the third censor and the argument, oh, no one would be motivated to make that a working censor.

[00:19:50] Speaker 01:
In our petition, we specifically references the portions of Winarda that says the sensor is made from the same substance, has the exact same reagent layer on it, and regardless of how you look at Winarda, that is going to generate an electrical current.

[00:20:07] Speaker 03:
Well, what record evidence did you submit that that third sensor can be adapted to take the specific calculations that are issued here?

[00:20:18] Speaker 01:
Well, what we reference is we reference page 109 of our application.

[00:20:22] Speaker 01:
We reference Winarta, Winarta column 5, line 37 to 54, 7, lines 11 to 42, and 9, 4 to 14, where it has all the capabilities.

[00:20:34] Speaker 01:
It's made from the same substance.

[00:20:36] Speaker 01:
It has the same reagent layer on it.

[00:20:38] Speaker 01:
And it does generate a current.

[00:20:40] Speaker 01:
The current generates initially, as defined in Winarta,

[00:20:43] Speaker 01:
is once the blood hits it, it causes the whole thing to start.

[00:20:47] Speaker 01:
So it triggers it.

[00:20:48] Speaker 03:
So you're conceding that there's nothing other than Wernarda itself that you're saying explains all this.

[00:20:54] Speaker 03:
There's no expert testimony.

[00:20:56] Speaker 03:
There's nothing that you put before the board to explain how that third sensor could be adapted.

[00:21:04] Speaker 01:
Yeah.

[00:21:05] Speaker 01:
The way it would be adapted, again, is to improve accuracy.

[00:21:08] Speaker 01:
If you have all of the steps of generating the current,

[00:21:11] Speaker 01:
You just need the one additional step of taking the measurement.

[00:21:14] Speaker 01:
Rather than just using the current as a trigger, use that current to take a measurement.

[00:21:20] Speaker 01:
And if you're using that current to take a measurement because your motivation is to increase accuracy.

[00:21:24] Speaker 03:
So you're admitting that what you had was looking at Bernarda and attorney argument, period.

[00:21:29] Speaker 01:
No, we also had Dr. Wang who said that you would do the same thing.

[00:21:32] Speaker 01:
If you're increasing accuracy, you can use something that has all the elements there to do it to just have it doing.

[00:21:42] Speaker 01:
And it would be obvious to do that because you have all of those elements.

[00:21:47] Speaker 01:
Having a trigger, having your last sensor act as a trigger increases accuracy because you've ensured that your sensor has been completely covered because it's not going to start measuring until you get to that other sensor.

[00:22:00] Speaker 01:
But then again, if you took it a step further, you're going to increase accuracy further

[00:22:04] Speaker 01:
if you have that other sensor, also take measurements, because then you can compare the two.

[00:22:09] Speaker 01:
You can address the issue that was raised by Schulman and raised by the other prior art, where you could have an error or a mistake in your sensor.

[00:22:16] Speaker 01:
That would provide that answer.

[00:22:18] Speaker 01:
And the motivation here, because we are dealing with a health care product, is to improve and create accuracy.

[00:22:27] Speaker 04:
Anything else?

[00:22:28] Speaker 04:
That's it.

[00:22:28] Speaker 01:
Thank you.

[00:22:28] Speaker 04:
OK.

[00:22:29] Speaker 04:
Thank you.

[00:22:41] Speaker 00:
Thank you, Judge Dyken.

[00:22:42] Speaker 00:
May it please the court.

[00:22:44] Speaker 00:
The director intervened in this appeal to address her authority to delegate the institution decision to the board.

[00:22:49] Speaker 00:
And as neither party has addressed that here, we are content to sit and rest on our brief as well, unless the court has questions.

[00:22:58] Speaker 04:
Thank you.

[00:22:58] Speaker 04:
Thank you.

[00:23:00] Speaker 04:
Now, Ms.

[00:23:02] Speaker 04:
Elderton, you have your bottle put on there.

[00:23:07] Speaker 05:
Thank you, Your Honor.

[00:23:09] Speaker 05:
There are a lot of moving targets here and I want to address two of them.

[00:23:13] Speaker 05:
One has to do with Minnarta.

[00:23:16] Speaker 05:
Throughout the proceeding in the patent office of the IPR, Pharmatech took the position that the WO electrode, that second electrode in Minnarta was capable of making a glucose measurement.

[00:23:27] Speaker 05:
It wasn't until we got the final written description, final written opinion, decision from the board where the board acknowledged that modifications would have to be made to Minnarta.

[00:23:39] Speaker 05:
to be able to make a reading there.

[00:23:41] Speaker 05:
And the board said, and somebody skilled in the art would be capable of doing that.

[00:23:45] Speaker 05:
Well, at that point, we have no opportunity to respond to that.

[00:23:50] Speaker 05:
Today, yet another moving target.

[00:23:53] Speaker 05:
Council argues, well, the motivation to combine these references is in the patents.

[00:23:57] Speaker 05:
That has never been argued anywhere.

[00:24:00] Speaker 05:
You can look at the briefs.

[00:24:01] Speaker 05:
It's never been argued that the motivation to combine Minnarta or Nankai with Schulman is found in the patents.

[00:24:08] Speaker 05:
The highlight has always been on the 19-word mantra from Dr. Wang that was repeated verbatim for 10 different prior art references as the motivation to combine all of them, a conclusory statement, a general statement, something that's not specific to particular references.

[00:24:26] Speaker 05:
So the argument now that is found in the references is yet another example of a moving target.

[00:24:32] Speaker 05:
The evidence, the only evidence of record that was ever presented

[00:24:37] Speaker 05:
for why one skilled in the art would not have looked to combine Nankai and Wenarta with Schulman was in the Smith's declaration, which was discounted by the board, not even mentioned.

[00:24:49] Speaker 05:
And Dr. Smith explained for a number of reasons why Schulman was so different from anything that Wenarta and Nankai were doing.

[00:24:58] Speaker 05:
The one skilled in the art wouldn't have gone there, because the sensors are implanted.

[00:25:03] Speaker 05:
They're awash with blood.

[00:25:04] Speaker 05:
It's not an instance

[00:25:06] Speaker 05:
where people, one, is comparing measurements from a single sensor system.

[00:25:11] Speaker 05:
In Shulman, it's two different sensors in different parts of the body, complete sensor systems, not two electrodes making measurements on a single strip.

[00:25:21] Speaker 05:
So that's all in the Smith Declaration.

[00:25:22] Speaker 05:
And that is the only evidence of record from the standpoint of somebody skilled in the art at the time of the invention with regard to motivation.

[00:25:31] Speaker 05:
And it supports LifeScan's position that there was no evidence of motivation.

[00:25:37] Speaker 04:
Okay.

[00:25:38] Speaker 04:
Thank you.

[00:25:41] Speaker 04:
Thank you.

[00:25:42] Speaker 04:
Thank both counsel.

[00:25:43] Speaker 04:
Thank all counsel.

[00:25:45] Speaker 04:
The case is submitted and that concludes our session for this morning.