[00:00:01] Speaker 03:
We will hear argument first in numbers 20, 22, 49, and associated cases.

[00:00:10] Speaker 03:
Kyogen North American Holdings against Handy Lab.

[00:00:17] Speaker 03:
You should, of course, feel free to, but are not obligated to remove your mask when you're at the lectern.

[00:00:23] Speaker 03:
But please, when you're sitting at the table, mask's on.

[00:00:28] Speaker 03:
Thank you.

[00:00:36] Speaker 00:
Good morning, Your Honors.

[00:00:38] Speaker 00:
May it please the court?

[00:00:40] Speaker 00:
This court has repeatedly held that claims are not to be treated as a nose of wax in criticizing a patentee's effort to interpret claims one way for the purpose of infringement and a different way for the purpose of validity.

[00:00:56] Speaker 00:
It should do the same here.

[00:00:58] Speaker 00:
In the related district court case for the purpose of establishing infringement, the patentee Handylab

[00:01:06] Speaker 00:
argued that claim language in these and related patents should be interpreted broadly and repeatedly emphasize the high standard required to narrow claim language through lexicography

[00:01:19] Speaker 00:
or disavowed.

[00:01:21] Speaker 03:
I'm sorry, can you get to the specifics of the particular claim construction at issue here, the multi-lane micro-flinted cartridge?

[00:01:32] Speaker 03:
Using different principles within the quiver of claim construction principles for different claim terms, it's commonplace.

[00:01:42] Speaker 03:
So you've got to get to the specifics.

[00:01:44] Speaker 00:
Absolutely.

[00:01:46] Speaker 00:
And I would note, for your honors,

[00:01:48] Speaker 00:
I understand these specifics, but in the district court case, HandyLab specifically argued that a clause at the end of the summary of the invention meant that the following detailed description meant that those embodiments were not limiting on the claims.

[00:02:07] Speaker 00:
And that same clause occurs in the 708 patent and the 900 patent that are at issue here.

[00:02:13] Speaker 00:
But as far as the specifics,

[00:02:17] Speaker 00:
The board made two errors, and the first was to require that each lane of the multi-lane microfluidic cartridge have both a microfluidic network and an inlet.

[00:02:30] Speaker 00:
And the board did that based on a sentence in the specification that the board concluded, quote, defines the structure of the sample lane, close quote.

[00:02:42] Speaker 00:
That sentence that the board relied on is not definitional.

[00:02:46] Speaker 00:
It was not describing, quote unquote, the invention, nor was it phrased in definitional terms.

[00:02:55] Speaker 00:
In addition, the sentence that the board relied on was in column 13 of the, and I'm citing from the 708 patent, but they have the same specifications.

[00:03:05] Speaker 00:
That's that appendix 270.

[00:03:08] Speaker 00:
But later in that same column, column 13, the specification actually describes the components that are part of a lane in different

[00:03:16] Speaker 00:
in broader ways.

[00:03:20] Speaker 00:
In particular, it says that a lane of a multi-lane cartridge comprises simply a microfluidic network.

[00:03:28] Speaker 03:
The word simply, is that in there?

[00:03:31] Speaker 00:
No.

[00:03:31] Speaker 03:
It isn't there.

[00:03:32] Speaker 03:
Isn't that the critical thing?

[00:03:35] Speaker 03:
One sentence says it has to have A and B. The next sentence says it has to have A, B, and C.

[00:03:43] Speaker 03:
Those are not inconsistent unless there was a word like simply or only or merely in there, which there isn't.

[00:03:50] Speaker 00:
I think the problem for HandyLab here is that the specification describes a lane in different ways, one broader and one narrower.

[00:04:00] Speaker 00:
And HandyLab is taking the position that the narrower description should control here.

[00:04:06] Speaker 01:
And the end conclusion is that you're trying to argue that the lane doesn't need an inlet.

[00:04:15] Speaker 01:
Correct.

[00:04:15] Speaker 01:
That's preposterous.

[00:04:19] Speaker 01:
How's the fluid going to get into the lane?

[00:04:22] Speaker 01:
Does it come through the back door?

[00:04:23] Speaker 01:
That is a fair point, and I think... I thought your refinery almost conceded as much.

[00:04:31] Speaker 01:
I think the issue here... That you have to be able to get the fluid into the lane.

[00:04:35] Speaker 00:
Absolutely, Your Honor.

[00:04:36] Speaker 01:
So how are you going to get it into the lane if the claim doesn't have an inlet?

[00:04:44] Speaker 00:
I think the issue here, Your Honor, is how the board subsequently interpreted inlet.

[00:04:50] Speaker 00:
If the term inlet simply has its plain and ordinary meaning, and that, you know, it's where the... Is this your best argument?

[00:04:56] Speaker 01:
I mean, you ordinarily lead with your best argument.

[00:04:59] Speaker 01:
Did you want to upset what the board did here?

[00:05:03] Speaker 01:
I mean, you're using a lot of time on this.

[00:05:06] Speaker 00:
Sure.

[00:05:08] Speaker 01:
I mean, you have an alternative holding here that there's no reasonable expectation of success in the combination.

[00:05:15] Speaker 01:
And that's a fact question.

[00:05:16] Speaker 01:
It comes to us on substantial evidence review.

[00:05:19] Speaker 01:
The board rejected your expert.

[00:05:22] Speaker 01:
The board said Dr. Northrup and the other expert are looking at two different, I mean, there's night and day between those two experts in what they see as the problems with combination.

[00:05:33] Speaker 01:
But how can we not accept that conclusion on the standard of review?

[00:05:40] Speaker 00:
Sure.

[00:05:40] Speaker 00:
If I may answer your first question first, and then I'll proceed to the reasonable expectation of success issue.

[00:05:46] Speaker 00:
So on the issue of inlets, if the inlet has its ordinary meaning, I think we would agree that Elaine, of course, has to have an inlet.

[00:05:54] Speaker 00:
That's a way the fluid has to get in there somehow.

[00:05:57] Speaker 00:
The problem is that the board then further limited the term inlet

[00:06:02] Speaker 00:
to specifically a structure that is a hole on the exterior of the cartridge.

[00:06:07] Speaker 00:
So there had to be a hole on the exterior of the cartridge associated with each lane.

[00:06:13] Speaker 00:
And that is not what the specification requires.

[00:06:18] Speaker 00:
And that can be seen, in particular, again, in column 13, where there's the sentence the board relies on that says, an inlet, I'm sorry, a sample lane comprises a sample inlet and a microcalidic network.

[00:06:32] Speaker 00:
then the very next sentence says, a sample lane can include a sample inlet port or valve.

[00:06:38] Speaker 00:
So everybody agrees that a sample inlet port is an optional feature.

[00:06:43] Speaker 01:
And Candy Lab tries... I come back to the same problem.

[00:06:46] Speaker 01:
So what if there's some error in the claim construction?

[00:06:49] Speaker 01:
The board, in its reasonable expectation and success analysis, was assuming, or you wonder, that you were going to, in a credit, going to have zoo would be part of the mix.

[00:07:01] Speaker 01:
And so I didn't see anywhere in your brief you pointed out to me why the reasonable execution success conclusion was infected or reversibly undermined by any errors in claim construction.

[00:07:16] Speaker 00:
Your Honor, I believe we do point that out in the briefing.

[00:07:19] Speaker 00:
I believe it's in the blue brief around pages 53.

[00:07:22] Speaker 01:
You say typically, if a claim construction error, you expect to have a vacate remand.

[00:07:27] Speaker 01:
But you don't explain to me why it's necessary here.

[00:07:30] Speaker 01:
The board's reasonable expectation of success analysis in its entirety didn't depend on these errors that you find in the claim construction.

[00:07:42] Speaker 01:
I didn't see it that way.

[00:07:45] Speaker 00:
Respectfully, Your Honor, their conclusion did depend on their erroneous claim construction.

[00:07:51] Speaker 01:
In what specific regard?

[00:07:53] Speaker 00:
Sure.

[00:07:53] Speaker 00:
So in several specific regards.

[00:07:56] Speaker 00:
So they started their analysis of reasonable expectation of success looking at this combination with the understanding that the Zao reference would have to be modified to have separate inlet ports for each of those microfluidic network lines.

[00:08:12] Speaker 00:
So once they started with that understanding, they then continued to analyze, OK, how could that be combined?

[00:08:20] Speaker 01:
And they- Could you walk me through the whole analysis where they're starting with that proposition?

[00:08:27] Speaker 00:
Sure.

[00:08:27] Speaker 01:
So I think if you go to the page on the record so I can sort of follow along where you are, there are two decisions here that are essentially the same because they're two patents.

[00:08:37] Speaker 00:
So I would refer you to the decision if it's 708 patent.

[00:08:41] Speaker 01:
And which page you were in the record.

[00:08:43] Speaker 00:
Excuse me.

[00:08:44] Speaker 00:
That would be appendix, starting around appendix 37.

[00:08:48] Speaker 01:
37?

[00:08:50] Speaker 00:
Correct.

[00:09:04] Speaker 01:
This is the state-of-the-art discussion.

[00:09:06] Speaker 00:
Correct.

[00:09:07] Speaker 00:
That's correct.

[00:09:07] Speaker 01:
There is a very difference of opinion between Northrop and your witness on what the state-of-the-art was.

[00:09:14] Speaker 00:
Correct.

[00:09:14] Speaker 00:
And if I could, Your Honor, I would point you to a single specific argument.

[00:09:18] Speaker 01:
I'm assuming for purpose of this argument that the 1030 exhibit was properly excluded.

[00:09:25] Speaker 01:
I'm assuming for purposes of this discussion we're having that you're not going to come in and say, well, there's a lot of stuff that was in the 1030.

[00:09:32] Speaker 01:
that bears on reasonable expectation of success.

[00:09:36] Speaker 00:
I absolutely think there was a lot.

[00:09:37] Speaker 01:
Oh, I know you were, but I'm asking you to pretend in your mind as if that's not the case.

[00:09:43] Speaker 00:
Understood.

[00:09:44] Speaker 03:
Walk through.

[00:09:45] Speaker 03:
I think we're beginning to tell us where the board, in your view, in the reasonable expectation analysis,

[00:09:53] Speaker 03:
says what we think is unexpectedly difficult is getting to a system in which each lane can simultaneously have physically different samples, which is, I think, your point about how this analysis depends on the claim construction.

[00:10:15] Speaker 03:
Show us where you think the board makes that dependency.

[00:10:19] Speaker 00:
Absolutely.

[00:10:20] Speaker 00:
I think some examples.

[00:10:22] Speaker 00:
occur on page 37.

[00:10:24] Speaker 00:
For example, the board's reliance on purported challenges with contamination and also the, quote, design and configuration of the microfluidic network.

[00:10:36] Speaker 00:
I think it's clear from the board's opinion that they were operating under the assumption that the design and configuration of Zao's microfluidic network would have to be substantially and materially changed in order to provide the claim element.

[00:10:50] Speaker 00:
I think

[00:10:51] Speaker 00:
It's also apparent in the board's discussion of challenges with interfacing.

[00:10:56] Speaker 00:
Interfacing the... Pages, pages.

[00:10:59] Speaker 00:
I'm sorry.

[00:11:00] Speaker 00:
Still on page 37.

[00:11:01] Speaker 00:
Okay.

[00:11:02] Speaker 04:
Functionally interfacing the reaction instrument with control machinery, which is in the middle of 37.

[00:11:08] Speaker 04:
Is that what you're referring to?

[00:11:10] Speaker 04:
Correct.

[00:11:10] Speaker 04:
That's what I'm referring to.

[00:11:13] Speaker 04:
What does that have to do with the claim construction?

[00:11:15] Speaker 04:
My understanding is what the board is doing here is saying, okay, you have a certain kind of layout or design in ZO, but that's on a chip, and it's not so...

[00:11:28] Speaker 04:
simple to transfer that layout design onto a cartridge that would then be popped into a machine so that a detector could then see and do all of the detection of the PCR reactions going on in all the different lanes.

[00:11:47] Speaker 04:
And then also at the same time, you know, have all the temperature controls and temperature uniformity across all the lanes.

[00:11:57] Speaker 00:
Sure, and I think a couple responses to that.

[00:12:01] Speaker 00:
One is on the temperature uniformity and the temperature control.

[00:12:05] Speaker 00:
That's what the Zao reference was all about.

[00:12:07] Speaker 00:
The Zao reference did that, solved those problems.

[00:12:11] Speaker 04:
For that chip.

[00:12:14] Speaker 04:
inside that particular contraption.

[00:12:17] Speaker 04:
Now the question is, how can you so easily lift that out and put it into this other context, which is the claimed context?

[00:12:26] Speaker 04:
And that was the question that Dr. Northrup said there was actually not so straightforward.

[00:12:31] Speaker 04:
It was pretty tricky, pretty complex.

[00:12:35] Speaker 00:
Sure.

[00:12:36] Speaker 00:
And I think

[00:12:37] Speaker 00:
I think that gets to a separate error in the board's analysis, which is that it did require us to show this bodily incorporation.

[00:12:43] Speaker 00:
How would each reference be physically changed in order to match sort of like Legos with the second reference?

[00:12:53] Speaker 00:
And that is clear in the law that that is not proper.

[00:12:56] Speaker 00:
But to get back to your earlier point about how does claim construction work into this situation, I think another example is on Appendix 38.

[00:13:07] Speaker 00:
where the board rejected Kaijin's expert opinion that the combination would just be the Zao microfluidic unit virtually unaltered at most with just a very basic plastic housing.

[00:13:23] Speaker 00:
And the board rejected that.

[00:13:25] Speaker 00:
And that was in large part due to their mistaken understanding of what the claims required and their understanding that

[00:13:35] Speaker 00:
would have to be made more complex with these different inlet ports and a different microfluidic network configuration in order to successfully interface with secondary references.

[00:13:48] Speaker 03:
Where do you think the board says a, what particular material on 38 are you relying on for tying the claim construction to

[00:14:02] Speaker 03:
this point about what a skilled artisan would have to do with Zao.

[00:14:10] Speaker 00:
So I'm on the bottom of page 38 where... This is the we also find sentence?

[00:14:16] Speaker 00:
Correct.

[00:14:16] Speaker 03:
But that doesn't refer to modifying it to make it possible for the lanes to concurrently have different fluids in it.

[00:14:26] Speaker 00:
It doesn't refer to that specifically, but that is the foundation that the board built its analysis on.

[00:14:32] Speaker 00:
And that's a large part of why the board concluded that this overall area was complex and difficult.

[00:14:39] Speaker 00:
It didn't look at the specific combination, which had these references that had solutions for these problems, and it was operating under the incorrect understanding that the ZO reference would have to be materially redone, altered,

[00:14:56] Speaker 00:
with this new port configuration that would then have to be interfaced with these systems.

[00:15:02] Speaker 03:
You have used almost every battle of time.

[00:15:04] Speaker 03:
We will restore the full five minutes, unless you want to keep going.

[00:15:10] Speaker 00:
I will take the full five minutes.

[00:15:11] Speaker 00:
Thank you, Your Honor.

[00:15:27] Speaker 02:
Mr. Saunders.

[00:15:28] Speaker 02:
Morning.

[00:15:28] Speaker 02:
May it please the court?

[00:15:30] Speaker 02:
If I could speak to this question, I think we have two independent grounds being given by the board.

[00:15:37] Speaker 02:
First, it's finding that we're missing a claim limitation, the multi-lane limitation based on its claim construction.

[00:15:44] Speaker 02:
And then independently of that, its analysis found the lack of a reasonable expectation of success.

[00:15:51] Speaker 02:
And the pages that we were just looking at in the final written decision don't

[00:15:57] Speaker 02:
don't blur those two together.

[00:15:58] Speaker 02:
They're not talking about we're having to make modifications to get to the mold.

[00:16:03] Speaker 01:
Except contamination.

[00:16:05] Speaker 02:
There is one reference to contamination, but that, I think, relates back to Dr. Northrup's testimony about if you're putting the chip inside the cartridge so you no longer have the direct access to the sample inlet,

[00:16:23] Speaker 02:
then you have to figure out where is that in the cartridge, and how does it interface?

[00:16:27] Speaker 01:
An appointment to the record citation for that testimony, would you please?

[00:16:31] Speaker 01:
For Dr. Nuthers.

[00:16:40] Speaker 01:
Thank you.

[00:16:52] Speaker 02:
So relevant portions of his declaration are starting at 3078 of the appendix.

[00:17:14] Speaker 03:
This is the material that the board cited when it was referring to contamination, which is... Right.

[00:17:22] Speaker 02:
I mean, the discussion of contamination is in a longer sentence there.

[00:17:27] Speaker 02:
But he had talked about the difficulty... Which paragraph on 3078?

[00:17:32] Speaker 02:
Well, 777, he talked about the packaging and finding the proper interface.

[00:17:38] Speaker 02:
There then was the discussion... Integrating.

[00:17:43] Speaker ?:
Assuring.

[00:17:44] Speaker 01:
healing temperature.

[00:17:47] Speaker 01:
Except for heating, I'm just looking for contamination.

[00:17:51] Speaker 02:
I don't think he specifically is using the word contamination when he's talking about the... So what words is he using that we would equate to... The words that correspond here for this section of the declaration are talking about the packaging and finding the proper

[00:18:09] Speaker 02:
interface so it's when you're packaging the chip inside the larger cartridge you have to figure out the way that you're going to interface how are you getting the fluid to that chip.

[00:18:31] Speaker 02:
We also have the issue separately then on the claim construction, the problem with the zoo chip itself, and the contamination there, it not being multi-laying.

[00:18:41] Speaker 02:
So I think when you look at, there's that one reference to contamination, the discussion that follows is focusing on the difficulties with the heating systems.

[00:18:51] Speaker 02:
I mean, this is a much broader discussion, classic substantial evidence review,

[00:18:57] Speaker 02:
one expert versus the other expert, where our expert's testimony was credited by the board and provides the substantial evidence to support the opinion.

[00:19:07] Speaker 01:
Well, I was looking at, if you look at 3502, we're talking here about your guy Northrop and what he's saying about contamination.

[00:19:18] Speaker 01:
3501, 3502, Northrop is actually talking about contamination.

[00:19:28] Speaker 01:
In fact, paragraph D says contamination on page 15, and this is of his expert declaration.

[00:19:39] Speaker 02:
Yes, thank you, Robert.

[00:19:40] Speaker 01:
So he's talking about the kind of contamination, cross-contamination, the inadvertent mixing of two different samples.

[00:19:49] Speaker 01:
So that's a problem that would come if we were construing the claim to be capable of or drawn to a capability.

[00:19:57] Speaker 01:
of using different kinds of samples simultaneously.

[00:20:02] Speaker 02:
Right.

[00:20:04] Speaker 02:
Yes, contamination is a concern.

[00:20:06] Speaker 01:
So that kind of contamination is related to the claim construction issue.

[00:20:14] Speaker 02:
That type of contamination would be related to the claim construction issue.

[00:20:17] Speaker 01:
Now, he then goes on to say, and or unintentional introduction of foreign DNA.

[00:20:24] Speaker 01:
Now, that can happen, can it, if you're just using one thing.

[00:20:29] Speaker 01:
Is there a possibility that in reservoir seven, for example, in zoo, you could have some unintentional foreign DNA in the common sample?

[00:20:44] Speaker 02:
You're absolutely right.

[00:20:45] Speaker 01:
Generally, there's a contamination problem whether you are using different kinds of samples or the same sample.

[00:20:51] Speaker 02:
Right, because one of the discussions of that was zoo being used in a serial fashion.

[00:20:56] Speaker 01:
But what I'm trying to get you to tell me is whether when the word and or is used by your expert, is he talking now about a situation in which you would not be using two different samples but be using the same sample?

[00:21:12] Speaker 02:
Well, I think that

[00:21:15] Speaker 02:
When you focus specifically on the problem of contamination, the concern is some other DNA getting in there.

[00:21:25] Speaker 02:
Usually that would be when you're doing different samples.

[00:21:28] Speaker 02:
There's always issues in the lab too with unintentional contamination.

[00:21:33] Speaker 01:
Would you agree that when we're talking about what your expert was saying about

[00:21:39] Speaker 01:
contamination and about the interrelationship of contamination of claim construction issue is your earlier reference to page 3078, paragraph 77, overwhelmed by what we pointed out at 3501.

[00:21:53] Speaker 01:
Your earlier were telling me that I should read what the board was thinking about contamination being what you cited in paragraph 707.

[00:22:05] Speaker 02:
Right.

[00:22:06] Speaker 02:
I think it could well be this part of his declaration.

[00:22:09] Speaker 02:
I apologize if I'm taking you to the incorrect page here.

[00:22:12] Speaker 01:
But the reference citation that I point to is far more specific on this one.

[00:22:15] Speaker 02:
That is far more specific about contamination.

[00:22:17] Speaker 02:
And I think what Rewind says is when you read- Let me ask you this question.

[00:22:21] Speaker 01:
Assume for purposes of argument I was troubled by the board's reading these claims as being drawn to a capability to receive multiple different types of samples.

[00:22:33] Speaker 01:
Assume I was troubled by that.

[00:22:35] Speaker 01:
And consequently, I would be troubled by the board relying on contamination as a ground for finding no reasonable expectation of success.

[00:22:45] Speaker 01:
Or would it be your argument that even if that was aired by the board, there is sufficient additional evidence that the board pointed to to support its conclusion that there was no reasonable expectation of success?

[00:22:57] Speaker 02:
Absolutely.

[00:22:57] Speaker 02:
So to answer the second point directly, the single- Why don't you walk me through the evidence

[00:23:04] Speaker 01:
that's a record that basically is coming from Northrop in opposition to the other expert data points in the analysis of the reasonable expectation of success that would support it, notwithstanding a concern that the court might have with the contamination issue.

[00:23:19] Speaker 02:
Right.

[00:23:20] Speaker 02:
So if we look at page 37 of the appendix, contamination is mentioned as just one part of a much longer list.

[00:23:29] Speaker 02:
The very next sentence

[00:23:31] Speaker 02:
The board specifically finds that Northrop provides factual support in reference to numerous contemporaneous publications.

[00:23:39] Speaker 02:
They find that he persuasively explains there were each in the

[00:23:44] Speaker 02:
If you see where I am on page 37, I'm not going to read it all.

[00:23:46] Speaker 02:
But the focus here is on the complexity of putting these together with a particular focus on the uniform temperature, optical detection, and multiple reaction chambers.

[00:23:59] Speaker 03:
Let me ask you another question.

[00:24:02] Speaker 03:
And the citation there is to paragraph 39, which is under interfacing, not under contamination.

[00:24:08] Speaker 02:
Correct.

[00:24:09] Speaker 02:
And then they go on and talk about, with reference to the particular challenges, and they cite paragraph 771 through 786, which I think is sort of the biggest block of his analysis.

[00:24:22] Speaker 02:
And that's where he talks about these challenges with

[00:24:27] Speaker 02:
the heating, the difficulty of maintaining that uniformity when you're putting this into a larger system.

[00:24:34] Speaker 01:
But the point I wanted to make is that the aspects from Dr. Northrop's testimony that are alluded to or that are specifically identified on page 37 are fewer in number than the total number of reasons why Dr. Northrop and his declaration found no reasonable expectation of success in the combination.

[00:24:54] Speaker 01:
I went back and made several additional points that were made by Dr. Northrup that are not referenced in the board opinion.

[00:25:03] Speaker 01:
When the board says that they credit the testimony because of the particular challenges listed above, does that mean they only credit the portions of Dr. Northrup's testimony that are relevant to the references cited in page 37?

[00:25:18] Speaker 01:
Or is the board essentially saying, we buy all of Northrup's

[00:25:25] Speaker 02:
I understood that they were buying all of Northrop, but if you look at that 7-7-1-3-7-8... I need to know how I'm supposed to read the clause because of the particular challenges listed above.

[00:25:38] Speaker 02:
Well, I think if you look at just the immediately preceding sentence, which is talking about the optical detection uniform temperature, those are the points.

[00:25:47] Speaker 02:
There's a citation.

[00:25:49] Speaker 02:
Things get addressed multiple times in this declaration.

[00:25:51] Speaker 02:
So there's a citation paragraph 39 of this declaration.

[00:25:53] Speaker 02:
The 771 through 786 cycles back through all of those concerns as well.

[00:26:00] Speaker 02:
There are additional things he talks about like the fragility of the beams that the board doesn't specifically call out in its decision, but at a minimum

[00:26:12] Speaker 02:
those concerns, whether the optical detection, uniform temperature would be enough.

[00:26:16] Speaker 02:
And if I may, you know, back up to the premise of this and the claim construction issue of what's giving you concern here, you know, we have a multi-lane cartridge, and so the question, there are multiple lanes, and the question is, well, what is a lane?

[00:26:33] Speaker 02:
And the specification in column 12 to 13 tells us exactly what a lane is, and it has to have a sample inlet.

[00:26:40] Speaker 02:
If you look throughout the specification, there's not a single example anywhere in the specification of a common sample inlet.

[00:26:50] Speaker 01:
The point is that each lane has to have an inlet.

[00:26:53] Speaker 01:
And one would grant you that.

[00:26:55] Speaker 01:
And the definition of an inlet is the place where the fluid goes into the diagnostic chamber.

[00:27:01] Speaker 01:
And that seemed to me no one would disagree with that.

[00:27:04] Speaker 01:
But to go further and to say,

[00:27:06] Speaker 01:
the entry into the diagnostic chamber has to be on the outside of the physical structure seemed to me to be quite a reach.

[00:27:13] Speaker 02:
Well, no.

[00:27:14] Speaker 02:
I mean, that is the way the board was looking at it.

[00:27:19] Speaker 01:
I understand that.

[00:27:20] Speaker 01:
But that seemed to me to be unnecessary reach, and certainly one that the BND wouldn't want to be stuck within litigation because you can design a structure where there's a housing that holds the whole thing.

[00:27:33] Speaker 01:
but that the lane in the diagnostic chamber is inside the housing, and that the place where the juice goes into the diagnostic chamber is inside, inside the housing.

[00:27:45] Speaker 01:
And on the claim construction from the board, the port has to be on the outside of the building, so to speak.

[00:27:53] Speaker 02:
But if it's a single lane, if they're connecting it through,

[00:27:57] Speaker 02:
then the inlet would be the one that is on the exterior.

[00:28:02] Speaker 02:
We are fine with that construction.

[00:28:03] Speaker 02:
That is what the benefit we're getting from this invention is you have the separate sample inlets.

[00:28:09] Speaker 02:
Each lane is kept separate, so you have an extreme amount of flexibility in terms of the ability to do different samples or not.

[00:28:17] Speaker 01:
If you have a valve that controls the flow of the fluid into the inlet and the valves an off-on valve so you can shut it off so nothing can get into the diagnostic chamber,

[00:28:27] Speaker 01:
That certainly would look like an inlet.

[00:28:30] Speaker 02:
No, I disagree.

[00:28:32] Speaker 02:
Here we have the board credited Dr. Northrup's testimony.

[00:28:36] Speaker 02:
This is at 829 of the appendix about the definition of inlet.

[00:28:41] Speaker 02:
And throughout the specification, every single example of inlet in the specification is at that interface.

[00:28:52] Speaker 02:
and the exterior of the cartridge.

[00:28:53] Speaker 02:
It repeatedly talks about column 14, talks about the sample inlet when a user introduces a sample into any cartridge.

[00:29:01] Speaker 03:
Is the language about the inlet is of the exterior of the cartridge?

[00:29:09] Speaker 03:
substantively different from saying that a multi-lane cartridge here must have the capability to accept physically different samples in each lane.

[00:29:25] Speaker 03:
Are those identical, or is there some daylight between those two?

[00:29:28] Speaker 02:
The latter follows from the former.

[00:29:30] Speaker 02:
In other words, the capability to accept the multiple samples, they're

[00:29:36] Speaker 02:
They're not reading that directly into the claim.

[00:29:39] Speaker 02:
They're interpreting what the apparatus is.

[00:29:42] Speaker 03:
Suppose I thought that I actually could not logically understand what they were saying about inlet apart from the capability.

[00:29:51] Speaker 03:
Right.

[00:29:54] Speaker 03:
I'm trying to understand if there's a success.

[00:29:56] Speaker 02:
One follows from the other.

[00:29:57] Speaker 02:
If you have a separate sample inlet and you have the separate lanes and that inlet's on the exterior, then

[00:30:05] Speaker 02:
then you are going to have that capability to do multiple samples.

[00:30:08] Speaker 02:
The capability flows from... Well, why is that so?

[00:30:11] Speaker 01:
I mean, every lane... Let's assume that what you want to do is to run a diagnosis on the same fluid.

[00:30:19] Speaker 01:
Not different types of fluid, but you want to run more than one test on the fluid.

[00:30:25] Speaker 01:
You want to test it for different things.

[00:30:28] Speaker 01:
So all you need to do is be able to get the fluid into the reaction chambers, right?

[00:30:33] Speaker 02:
if that is what you're doing, and the great advance of this, part of the advance of this invention here, is that you have the flexibility to do that, or you have the flexibility to do all of this.

[00:30:44] Speaker 01:
Well, we have that because of three citations in the specification.

[00:30:48] Speaker 01:
There's nothing in the drawings that suggests that you can't have a common reservoir.

[00:30:53] Speaker 02:
Well, I would put it the other way.

[00:30:54] Speaker 02:
There is not a single example

[00:30:58] Speaker 02:
anywhere in this patent of a common reservoir.

[00:31:01] Speaker 01:
Every single drawing.

[00:31:02] Speaker 01:
There's no example of any reservoir.

[00:31:04] Speaker 01:
Right.

[00:31:05] Speaker 01:
Every single drawing.

[00:31:06] Speaker 01:
So the claim is drawn broadly enough to read on zoo.

[00:31:10] Speaker 01:
To read on a common reservoir situation.

[00:31:15] Speaker 02:
Isn't it?

[00:31:17] Speaker 02:
No.

[00:31:17] Speaker 02:
Absolutely not.

[00:31:18] Speaker 02:
Why not?

[00:31:19] Speaker 02:
Absolutely, because it tells you you have the separate sample inlets.

[00:31:23] Speaker 02:
You have all of the extrinsic evidence.

[00:31:26] Speaker 02:
Every single example in the specification is showing the inlet as the connection at the exterior.

[00:31:33] Speaker 01:
But that has nothing to do with what kind of fluid is being put in.

[00:31:39] Speaker 01:
It has nothing to do with that.

[00:31:40] Speaker 02:
It creates the capability.

[00:31:42] Speaker 01:
It creates an opportunity for having different types of fluids put in, but it isn't required.

[00:31:48] Speaker 01:
Is there any language in the claim that's drawn to capability?

[00:31:53] Speaker 01:
Finjam language.

[00:31:56] Speaker 01:
Yes or no?

[00:31:58] Speaker 02:
In the claim.

[00:31:59] Speaker 02:
The claim itself doesn't speak of capability.

[00:32:01] Speaker 02:
The claim defines the apparatus that creates that capability.

[00:32:07] Speaker 02:
If you have the separation that's required by the claim and you have the

[00:32:11] Speaker 02:
uniform description of the invention throughout, then you will have that capability.

[00:32:17] Speaker 01:
It flows from the claim to... Is your claim thus limited to an apparatus that deals with multiple different fluids so that zoo would not infringe?

[00:32:30] Speaker 02:
No, I think... Why not?

[00:32:32] Speaker 02:
It has the capability because it has multi-lane, separate sample inlets.

[00:32:40] Speaker 01:
Is that a claim requirement?

[00:32:41] Speaker 01:
Yes, that is a claim requirement.

[00:32:44] Speaker 01:
Does that define the scope of your claim?

[00:32:48] Speaker 01:
Yes.

[00:32:48] Speaker 01:
Your claim is your patent only reads on devices that analyze multiple fluids.

[00:32:55] Speaker 03:
multiple different fluency devices that are structured such that they could or you could introduce the same flexibility in a way you don't have soon you have no problem with the proposition that zoo does not infringe yes we could zoo does not infringe can i ask you one question i know we're a little over time so i think we need to wrap this up um you say uh that claim 30 add something to claim one what

[00:33:22] Speaker 02:
So in Claim 1, the detection is in the PCR reaction zone.

[00:33:31] Speaker 02:
And in Claim 30, it's detection in the sample itself.

[00:33:35] Speaker 02:
Detection what?

[00:33:36] Speaker 02:
In the sample itself.

[00:33:38] Speaker 02:
In the sample?

[00:33:40] Speaker 02:
Yes.

[00:33:40] Speaker 02:
So if you look at Claim 1, the detection

[00:33:59] Speaker 02:
Claim one says, quote, to detect the presence of an amplification product in the respective PCR reaction zone.

[00:34:06] Speaker 02:
And the language in claim 30 is talking about detecting the presence of an amplification product in each of the samples.

[00:34:15] Speaker 02:
So it's the difference of you've detected it in the chamber.

[00:34:18] Speaker 02:
Now, claim one obviously encompasses what you have in the dependent claim.

[00:34:23] Speaker 02:
You could be detecting it in the sample while the sample is in the chamber.

[00:34:27] Speaker 03:
But that's not strictly required, I claim.

[00:34:30] Speaker 03:
I must say, until this moment, I had no idea what you thought the difference was between them.

[00:34:35] Speaker 02:
Oh, I apologize.

[00:34:37] Speaker 02:
No, and this wasn't developing.

[00:34:39] Speaker 02:
The claim differentiation argument hadn't been made below.

[00:34:42] Speaker 02:
And so it's being developed on appeal.

[00:34:44] Speaker 04:
Is there a pending district court litigation?

[00:34:46] Speaker 02:
There is a pending district court litigation, yes.

[00:34:48] Speaker 04:
And did you take a different position on claim construction for multi-lane microfluidic cartridge?

[00:34:53] Speaker 02:
No.

[00:34:54] Speaker 02:
Multi-lane, it's the same construction.

[00:34:56] Speaker 02:
That's the construction that Judge Stark adopted in that case.

[00:35:01] Speaker 02:
Where we're being accused of an alleged inconsistency is on the construction of valve.

[00:35:07] Speaker 02:
And the context there is completely different.

[00:35:10] Speaker 02:
That's a different patent with a different specification.

[00:35:12] Speaker 02:
The question is, does the valve have to be normally open?

[00:35:17] Speaker 02:
There there's an example of a valve that is, quote, normally closed.

[00:35:21] Speaker 04:
uh... date unlike here we don't have any treatise article anything that's fine but i just want to know did multilane microfluidic cartridge get construed in the district court and if so is it the exact same constructions of the board here where the here just to be clear it's not just having a sample input inlet and its own microfluidic network but it's also the medic instruction that the board here did to the term sample inlet

[00:35:50] Speaker 04:
That second level issue... The capacity to construct that each lane handles its own separate and independent sample.

[00:35:59] Speaker 02:
That didn't come up as an issue of claim construction in the district court.

[00:36:07] Speaker 02:
Quite frankly, it wasn't presented as an issue of claim construction in this case.

[00:36:10] Speaker 02:
It has arisen because of the application of the claim construction to do.

[00:36:15] Speaker 02:
There hasn't been anything in the district court

[00:36:20] Speaker 02:
court to sort of get into a second level issue like that, but we think that is the correct reading of the claim.

[00:36:27] Speaker 02:
There's no inconsistency.

[00:36:30] Speaker 03:
Thank you, Mr. Sanders.

[00:36:52] Speaker 00:
Just a few brief responding points, Your Honors.

[00:36:56] Speaker 00:
First of all, there was some discussion about is there enough evidence on the issue of reasonable expectation of success other than this contamination issue to affirm?

[00:37:07] Speaker 00:
And I think the answer, first of all, is no.

[00:37:10] Speaker 00:
This issue of contamination and then design and configuration of the microfluidic network, that's something the board

[00:37:19] Speaker 00:
focused on and it's again at appendix 37 where the board kind of summarizes its reasons why it didn't think there was a reasonable expectation of success.

[00:37:28] Speaker 00:
Those are two of the primary things listed there.

[00:37:32] Speaker 00:
And it's just impossible to kind of get inside the board's head and understand how much that weighed into the board's decision.

[00:37:40] Speaker 00:
And I think the only way to kind of fix this error is to remand to the board so that they can do a new analysis using the correct claim construction

[00:37:50] Speaker 00:
under the correct understanding of what the structure is that the claims require before you get to the subsequent analysis of, okay, would a person with an ordinary skill expect to be able to combine these things using only routine engineering, or is there something kind of more difficult about this?

[00:38:09] Speaker 00:
And I think this issue of contamination, that was a very big material issue in the underlying IPR, and you heard counsel say,

[00:38:18] Speaker 00:
That's the benefit we're getting from this invention.

[00:38:21] Speaker 00:
They focused on this contamination issue to get their claim construction.

[00:38:28] Speaker 00:
It is a core part of this IPR and it's just impossible to divorce the issue of contamination from what happened in front of the board.

[00:38:38] Speaker 03:
Can I just push back a little bit on that just to get clarity?

[00:38:45] Speaker 03:
If a decision maker says on reasonable expectation of success, there are six challenges that a skilled artisan would have needed to meet with a reasonable expectation of success.

[00:38:59] Speaker 03:
I don't see the evidence for reasonable expectation of solving any of the six.

[00:39:07] Speaker 03:
Then even if one of them was infected by a misunderstanding,

[00:39:12] Speaker 03:
there would still be five challenges for which there would be a finding that the skilled artisan didn't reasonably expect success.

[00:39:24] Speaker 03:
That sort of skeleton, that scenario, why is this case not that?

[00:39:31] Speaker 03:
Even assuming contamination was a problem.

[00:39:37] Speaker 00:
I think this case certainly was not that situation.

[00:39:42] Speaker 00:
That's largely due to the fact that contamination was the primary benefit that HandyLab focused on and emphasized to the board that that is the benefit of this invention and used that to differentiate it from Zao.

[00:39:58] Speaker 00:
So the board viewed that as a very important part of the invention.

[00:40:03] Speaker 00:
I think beyond that,

[00:40:08] Speaker 03:
I think you made in your brief, I'm not sure if I remember this right, maybe a passing reference to the idea that even if we were to reject the claim construction, that even if we thought the reasonable expectation of success conclusion of the board was sound, that

[00:40:30] Speaker 03:
there would nevertheless be something to remand.

[00:40:34] Speaker 03:
Did you make a suggestion?

[00:40:35] Speaker 03:
And if so, what did you have in mind?

[00:40:38] Speaker 00:
Sure.

[00:40:39] Speaker 00:
And that goes to this issue with exhibit 1030.

[00:40:43] Speaker 00:
And you had asked me earlier to assume that we're not talking about that.

[00:40:48] Speaker 00:
I would like to briefly talk about that if that's all right with your honor.

[00:40:52] Speaker 00:
I know it wasn't specifically discussed earlier, but

[00:40:56] Speaker 00:
We believe that is a core part of the reasonable expectation of success evidence.

[00:41:01] Speaker 00:
And it was very clear in the board's decision that they just disregarded that.

[00:41:07] Speaker 00:
And I think I can point, Your Honors, again, Paige.

[00:41:13] Speaker 03:
But the board said that it wasn't relying on it expressly.

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

[00:41:17] Speaker 00:
Correct.

[00:41:18] Speaker 00:
But the way that it said that made clear that it recognized that that was key material evidence because

[00:41:26] Speaker 00:
The sentence that precedes that is the petitioner's assertion that using a microfluidic chip, PCR chip, like ZO1 as a cartridge was routine and predictable by March 2006, however, is based on Exhibit 1030, which the petitioner did not submit with the petition.

[00:41:44] Speaker 00:
So the board's only response to our evidence that using ZO1 as a cartridge would have been routine and predictable

[00:41:52] Speaker 00:
was to say, well, yes, but that's based on exhibit 1030.

[00:41:55] Speaker 00:
So we're not going to consider it.

[00:41:58] Speaker 01:
So that was an image that's in the backdrop of the board starting off by saying that your whole expectation of success argument, in their view, was sketchy and was just sort of like

[00:42:12] Speaker 01:
chicken scratch in the record in the very beginning, that you hadn't put much effort into making that argument in your petition or in your response.

[00:42:23] Speaker 01:
I mean, I read that to the board to have that in its mind.

[00:42:26] Speaker 01:
And it says, then you come in with 10.30 late, and we're just not going to let it in as a matter of case management under the rules.

[00:42:36] Speaker 00:
That is part of what the board said, your honor.

[00:42:39] Speaker 01:
And for me, and as it is for you as well, I think 1030 is the elephant in the room.

[00:42:46] Speaker 00:
Absolutely.

[00:42:47] Speaker 01:
And the case is demonstrably weaker without it.

[00:42:51] Speaker 00:
And I think the board's conclusion that you referenced, that the reasonable expectation of success was conclusory, is just not supported.

[00:43:01] Speaker 00:
The board focused

[00:43:02] Speaker 00:
very myopically on how many times Kaijin used the phrase reasonable expectation of success.

[00:43:08] Speaker 00:
And it ignored the other evidence that Kaijin provided and submitted that showed a reasonable expectation of success.

[00:43:15] Speaker 00:
And we talk about some of that in our briefing and a couple specific points of evidence.

[00:43:24] Speaker 00:
The Zao reference itself said, my device can be used with current macro thermal cyclers that exist in the Arctic.

[00:43:32] Speaker 00:
So it taught that its device, its multi-lane device, was intended to be used with other systems.

[00:43:47] Speaker 03:
That wouldn't quite establish that a skilled artisan would actually be able to do it.

[00:43:54] Speaker 03:
We intend this, lots of intents around the world.

[00:43:58] Speaker 00:
What it shows is that

[00:44:00] Speaker 00:
This, you know, the way of using something like Zao with another system was just routine engineering.

[00:44:07] Speaker 00:
That's what that statement shows.

[00:44:09] Speaker 00:
And we also cited other evidence, for example, the fact that- That was routine?

[00:44:14] Speaker 00:
I'm sorry?

[00:44:14] Speaker 01:
Routine?

[00:44:17] Speaker 01:
That kind of combination would be routine?

[00:44:18] Speaker 00:
Yes, absolutely.

[00:44:20] Speaker 01:
Is that word in the, in zoo?

[00:44:23] Speaker 00:
Oh, that's not in zoo, but the other evidence in the record shows that.

[00:44:26] Speaker 03:
The board didn't disregard any other evidence, did it?

[00:44:29] Speaker 00:
It largely did because of its mistaken conclusion that we didn't put enough evidence of reasonable expectation of success in the petition.

[00:44:38] Speaker 03:
And that conclusion, by the way, I think... I thought it went on to address that evidence anyway.

[00:44:44] Speaker 00:
It addressed some of it, but critically, it did not address Exhibit 1030.

[00:44:48] Speaker 00:
Also, it did not address... One of our primary secondary references was Puramati.

[00:44:54] Speaker 00:
And Pooramati expressly taught, here's some ways you can put a microfluidic chip into a cartridge.

[00:45:00] Speaker 00:
It said, you can glue it.

[00:45:02] Speaker 00:
You can carve out a recess and then clamp it in there.

[00:45:05] Speaker 00:
And the board just ignored that.

[00:45:08] Speaker 00:
And I think the board's conclusion that we didn't put enough reasonable expectation of success evidence in the petition, it was all the more unfair because the board instituted review in this IPR over HandyLab's objections

[00:45:24] Speaker 00:
that reasonable expectation of success evidence was conclusory.

[00:45:28] Speaker 00:
And it invited the parties to further brief the issue, to develop the record.

[00:45:31] Speaker 00:
And then when Kaijin tried to do that, the board then effectively reversed the decision on that same claim and just disregarded key reply evidence.

[00:45:44] Speaker 03:
There comes a time in every argument when we have to call a halt.

[00:45:46] Speaker 03:
And now is the time.

[00:45:47] Speaker 03:
Thank you.

[00:45:48] Speaker 03:
Thanks for your time, sir.