[00:00:00] Speaker 04:
Five, Ariosa Diagnostics versus Varinata Health.

[00:00:13] Speaker 04:
OK, we're going to shift gears now.

[00:00:14] Speaker 04:
Mr. Lemley, whenever you're ready.

[00:00:17] Speaker 02:
May it please the court.

[00:00:18] Speaker 02:
Given the setting, would it be helpful for me to start with a brief recitation of the facts?

[00:00:22] Speaker 04:
Sure.

[00:00:23] Speaker 02:
So let me both.

[00:00:25] Speaker 00:
And completely neutral and fair, right?

[00:00:27] Speaker 02:
Absolutely.

[00:00:28] Speaker 02:
Absolutely.

[00:00:29] Speaker 02:
Both parties in this case, Your Honor, provide genetic tests for aneuploidy, also known as Down syndrome.

[00:00:39] Speaker 02:
Now, that's not the invention.

[00:00:41] Speaker 02:
That was well established in Dotlin.

[00:00:43] Speaker 02:
They use for this test cell-free fetal DNA.

[00:00:47] Speaker 02:
So while prior tests had required amniocentesis and a large needle to be inserted into the womb, cell-free fetal DNA dispenses with the need for that.

[00:00:58] Speaker 02:
That too is not the alleged invention here.

[00:01:00] Speaker 02:
That also is taught in Dahlin.

[00:01:03] Speaker 02:
The patent claims that you can take these samples from a variety of sources and combine them together.

[00:01:12] Speaker 02:
Now, that was taught in part in Shoemaker.

[00:01:14] Speaker 02:
Shoemaker teaches that you can index and tag samples from various different sources.

[00:01:22] Speaker 02:
But in Shoemaker, all of those sources are from the same person.

[00:01:25] Speaker 02:
So the alleged point of novelty in this case.

[00:01:28] Speaker 00:
And they're actually cells.

[00:01:31] Speaker 02:
And in Shoemaker, they are also cells.

[00:01:32] Speaker 02:
That's right.

[00:01:33] Speaker 02:
In Dahlin, they are cell-free fetal DNA.

[00:01:35] Speaker 02:
The alleged point of novelty in this case is the use of multiple patients samples in the same testing, so-called multiplexing.

[00:01:45] Speaker 02:
Now, what we offered before the board was both evidence of a specific third reference, the Bin Laden reference, which taught multiplexing.

[00:01:53] Speaker 02:
But we also offered a description of the state of the art, which demonstrated that multiplexing was well known and that there were indeed products already commercially available for sale, such as the Illumina gene sequencing system, that did multiplexing.

[00:02:09] Speaker 02:
So we think the first error the board made here was in ignoring that evidence of state of the art.

[00:02:15] Speaker 03:
And the question is, oh, please.

[00:02:17] Speaker 03:
Mr. Lemley, in your blue brief at 30,

[00:02:21] Speaker 03:
You say the board recognized that the prior art references and combinations satisfied all the claim limitations.

[00:02:28] Speaker 03:
And you quote JA 16.

[00:02:31] Speaker 03:
I looked and looked, can't find it.

[00:02:34] Speaker 03:
Where do they say we recognize that the prior art references in combination satisfy all that?

[00:02:41] Speaker 02:
Your honor, they say it with some equivocation.

[00:02:48] Speaker 02:
Maybe, maybe.

[00:02:48] Speaker 02:
With some equivocation.

[00:02:49] Speaker 02:
So at A11.

[00:02:51] Speaker 02:
They cite the references and the motivation to combine all of those references.

[00:02:58] Speaker 02:
In addition, petitioner provides a claim chart detailing where various elements of the challenge claims can be found in Shoemaker, Dahlin, and Bin Laden.

[00:03:05] Speaker 02:
And for each element or cause of the claims, claim chart purportedly identifies where some aspect of that element or clause is disclosed.

[00:03:12] Speaker 02:
Now purportedly is of course the magic word there.

[00:03:16] Speaker 02:
But there is no finding in the board at any time that any

[00:03:21] Speaker 02:
that there's any part of the claim that is not taught in one of these three references.

[00:03:25] Speaker 03:
So you're saying that's how they recognize it?

[00:03:27] Speaker 02:
They recognize it there.

[00:03:28] Speaker 02:
They then go on to discuss it, I think, in the combination in A15 and A16.

[00:03:38] Speaker 02:
All of this board's discussion is premised on the assumption that all of the elements individually are present.

[00:03:45] Speaker 02:
There is certainly no board finding that any of the elements is absent.

[00:03:49] Speaker 02:
The only thing that's absent is the combination in one single reference.

[00:03:56] Speaker 02:
And so I think this is a classic.

[00:03:58] Speaker 00:
But let me say, I mean, I take it that the gist of the board's decision is that what is absent is a understandable explanation of why the hypothetical relevant skilled artisan would have been motivated

[00:04:18] Speaker 00:
to take these pieces from different prior art, shed some of what those pieces of prior art taught.

[00:04:28] Speaker 00:
We're not going to do distinguishing the fetal from the maternal samples anymore, all with a reasonable expectation of success.

[00:04:39] Speaker 00:
And in a proceeding, in a forum in which speed is an imperative,

[00:04:48] Speaker 00:
you have got to put that explanation, the connective tissue, into the petition and can't rely on kind of two level down pieces of evidence submitted in the record.

[00:05:01] Speaker 02:
Understood, Your Honor.

[00:05:02] Speaker 02:
I mean, I think one of the difficulties here is that the board has sort of shifted its ground in practice as to whether it wants the claim charts in the petition itself, as it did at the time, or whether it now wants them attached

[00:05:17] Speaker 02:
We did, in fact, in the record at 209, specifically give the motivation to combine references in the petition.

[00:05:25] Speaker 02:
And we then referred to the expressed discussions of those motivations in the Nussbaum Declaration and the Morton Declaration.

[00:05:35] Speaker 02:
The board was well aware of this.

[00:05:36] Speaker 02:
This was not an area, a case in which they simply failed to find it.

[00:05:40] Speaker 02:
The board at A11... I'm sorry, can I ask you... Certainly.

[00:05:43] Speaker 00:
You explained the 209 is the six lines before the claim chart starts.

[00:05:49] Speaker 00:
That's correct.

[00:05:50] Speaker 00:
But all that says is that Nussbaum and Morton explained in their declarations that a skilled artisan would also have readily understood that Shoemaker's methods could be carried out.

[00:06:01] Speaker 00:
Could is not I would.

[00:06:04] Speaker 02:
So that is correct, Your Honor, but I think understanding the skilled artisan that they could carry it out, right, is the very thing the board ultimately decides is missing here.

[00:06:15] Speaker 02:
The board never says there's no motivation to combine.

[00:06:18] Speaker 02:
The board says we don't know how you would combine.

[00:06:21] Speaker 02:
In fact,

[00:06:22] Speaker 02:
The board itself quotes at length.

[00:06:24] Speaker 00:
Right, but suppose I read that to mean, I mean, the board used language that had a certain element of frustration.

[00:06:32] Speaker 00:
That is, you're making us do far too much work.

[00:06:35] Speaker 00:
And when it said you agree that changes would have to be made in particular pieces you point to and to combine, you haven't explained how all of this would be understood by a relevant skilled artisan.

[00:06:52] Speaker 00:
And maybe I'm now adding something, but I took implicitly, you were saying, or therefore why somebody would want to do that.

[00:06:59] Speaker 02:
Well, I think we did very clearly explain in the Nussbaum Declaration why someone would want to do it.

[00:07:05] Speaker 02:
And the board understood that, and they quoted it at length in their decision at A11.

[00:07:10] Speaker 02:
As to the motivation to combine, Dr. Nussbaum said, I believe one of skill in the art

[00:07:15] Speaker 02:
would have been motivated to combine these techniques as the combination would clearly result in an enhanced productivity and increased throughput of sample analysis.

[00:07:23] Speaker 02:
The sequencing and multiplexing technology of Bin Laden would have made the procedures of Shoemaker and Dahlin less expensive, faster, and more efficient because one could sequence index samples from many different patients in a single sequencing run.

[00:07:36] Speaker 02:
That is precisely the sort of

[00:07:38] Speaker 02:
motivation, intrinsic, improve the operation of the science that KSR recognizes.

[00:07:45] Speaker 00:
Can I ask you, this is shifting gears a little bit, and it's one form of the question is, why didn't you argue?

[00:07:53] Speaker 00:
So there are the two Chu references.

[00:07:56] Speaker 00:
Mid 2008, or end of 2008, December 2008, and then June of 2009.

[00:08:04] Speaker 00:
They could not be clearer, I think,

[00:08:07] Speaker 00:
in describing conceptually the counting process that is described and claimed in this 430 patent.

[00:08:19] Speaker 00:
And at least the second one, probably even the first one is, and they refer to the Illumina genome analyzer.

[00:08:28] Speaker 00:
Second one at least is even after the genome indexing kit brochure, and yet

[00:08:35] Speaker 00:
There is no obviousness case presented based on Chu.

[00:08:40] Speaker 02:
So Your Honor.

[00:08:41] Speaker 00:
Can you explain?

[00:08:42] Speaker 02:
I was not counsel before the board, but my understanding.

[00:08:46] Speaker 00:
What's your second answer?

[00:08:48] Speaker 02:
But my understanding of the rationale is that the counsel before the board wanted to focus on prior art references that were not cited on the face of the patent because they believed the board was more likely to pay attention to those references.

[00:09:03] Speaker 00:
That said... That's a kind of a strategic consideration.

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

[00:09:06] Speaker 02:
No, that's right.

[00:09:07] Speaker 02:
And so we are not relying on Chu here as a prior reference.

[00:09:12] Speaker 03:
That said... In your list of why didn't you mention questions then, you have a heading at 25, the board erred in ignoring evidence of the background knowledge regarding the Illumina genum analyzer.

[00:09:27] Speaker 03:
A person of ordinary skill would have had with respect to DNA indexing

[00:09:33] Speaker 03:
Apart from a brief mention of the alumna brochure in your expert's declaration, that argument seems to me to be raised for the first time in your reply brief to the board.

[00:09:48] Speaker 03:
Absolutely not, your honor.

[00:09:49] Speaker 02:
Okay, first.

[00:09:50] Speaker 02:
Show me where.

[00:09:50] Speaker 02:
First, it is raised in the petition itself, 178 and 179.

[00:09:55] Speaker 02:
We have a whole section of the background on the art, and that section on 179

[00:10:01] Speaker 02:
explains that multiplexed massively parallel sequencing of a pooled sample, which is precisely what we're talking about from Illumina, e.g., efficiently sequencing a mixed or pooled sample containing the DNA fragments from several different individuals after indexing the DNA fragments from each individual, were also well-known and in widespread use as of 2010.

[00:10:22] Speaker 02:
That then refers to both the Nussbaum and the Morton declarations, which specifically call out the Illumina system,

[00:10:28] Speaker 02:
They are attached and submitted to the board with the petition.

[00:10:32] Speaker 02:
In fact, the Illumina system is mentioned not once but twice in the 430 patent itself as background, as background art.

[00:10:40] Speaker 02:
And in the institution decision, the board itself specifically acknowledges that the Illumina gene analyzer is present and that it is taught in Shoemaker as a reference.

[00:10:51] Speaker 02:
So there is, I think, no reasonable way to conclude that this was raised for the first time.

[00:10:56] Speaker 02:
What did happen, I think, is that, quite frankly, this was, in our view, background.

[00:11:01] Speaker 02:
Everybody knew that you could, in fact, multiplex.

[00:11:04] Speaker 02:
And people had been doing it, that there were commercial products designed precisely to do it.

[00:11:09] Speaker 02:
And it was only when Verinada, to our view somewhat oddly, decided to make that their stand in opposing the obviousness case that we then discussed it in more detail.

[00:11:20] Speaker 02:
But the Illumina evidence is presented as the state of the art, as background art.

[00:11:27] Speaker 02:
And the board chose to give it, quote, no weight, because it wasn't identified as a separate prior art reference, but instead only in the state of the art.

[00:11:37] Speaker 02:
That is directly contrary to this court's decision in Randall versus Ray.

[00:11:42] Speaker 00:
Can I return?

[00:11:43] Speaker 00:
I know how Randall works, so can I return you to the Chiu

[00:11:50] Speaker 00:
question.

[00:11:51] Speaker 00:
Yes sir.

[00:11:52] Speaker 00:
Suppose you were to try to tell me right now what's missing with respect to the 430 in at least the combination of the two CHU references.

[00:12:03] Speaker 02:
I don't know that there is anything missing your honor but I mean I think the thing.

[00:12:09] Speaker 00:
What's odd here and I kind of infer that this is what the board thought was odd was that you were making an argument based on prior art references that were

[00:12:20] Speaker 00:
substantially different methods.

[00:12:24] Speaker 00:
The one with the cells, the one with the allele-based method, in each of which there was an effort, a required effort, to distinguish stuff from the fetus and stuff from the mother.

[00:12:38] Speaker 00:
And everybody kind of knew that, I guess back in the old days of Dolan,

[00:12:45] Speaker 00:
prehistoric times, nobody was quite sure what the ratio of the fetal DNA was compared to the maternal DNA in the plasma.

[00:12:53] Speaker 00:
And until you knew that ratio, total counting would give you gibberish as information.

[00:12:58] Speaker 00:
But by 2008, everybody knew.

[00:13:00] Speaker 00:
Chu says, very small, very small.

[00:13:03] Speaker 00:
And so you needed a large, large statistical sample for the counting to give you a meaningful difference.

[00:13:13] Speaker 00:
Yes.

[00:13:13] Speaker 00:
by 2008 or at least by January 2010, there were ways of getting those large samples.

[00:13:20] Speaker 00:
And Chu seems to suggest that.

[00:13:23] Speaker 00:
And I think the board was thinking, why are you starting from this bizarre place of radically different techniques and picking pieces?

[00:13:34] Speaker 02:
Your Honor, as I said earlier, I think the decision to choose these references was a decision based on the fact that they were not cited on the face of the patent.

[00:13:43] Speaker 02:
But I would suggest that the fact that there are, as I believe there are, other references that also render the Verinada patent obvious can't be used as a basis to defend the board's decision.

[00:13:55] Speaker 00:
Unless the fact that the references that quite specifically discuss the actual counting technique being used here, by not being cited and communicate, there was actually something missing.

[00:14:13] Speaker 00:
in a skilled artisan's understanding of whether that technique, the actual technique, not the Dahlin technique or the Shoemaker technique, which are meaningfully different, could be used with the reliability implicit in prenatal testing.

[00:14:29] Speaker 02:
So, Your Honor, let me suggest that there is absolutely nothing in the board's opinion that suggests that that is their conclusion.

[00:14:36] Speaker 02:
There is no discussion of the references.

[00:14:38] Speaker 02:
that you're talking about, there is no discussion of the counting issue at all.

[00:14:41] Speaker 02:
There is no discussion in Verinata's briefing or, frankly, at all in the board below on that issue.

[00:14:47] Speaker 02:
And I think this leads me to the Chenery point.

[00:14:50] Speaker 02:
If, in fact, it is the case that the board could have come to a conclusion like that but didn't put it on the record, that itself is independent grounds for remand.

[00:15:02] Speaker 02:
This court and the Supreme Court in Chenery have made it very clear

[00:15:05] Speaker 02:
that the board's obligation under the Administrative Procedure Act is to set out in detail the factual findings they are making.

[00:15:12] Speaker 00:
And it's possible, at least, and I know you're not prepared to concede this, but that if the matter went back to the board, that the board could say, our procedures are such that it is important that we insist on certain levels of explanation in the petition

[00:15:34] Speaker 00:
And we're not going to give you an opportunity to make new arguments.

[00:15:38] Speaker 00:
We're just going to make new findings.

[00:15:39] Speaker 02:
I think that is entirely possible, Your Honor.

[00:15:42] Speaker 02:
And if that happens on remand, we will deal with that on remand.

[00:15:46] Speaker 02:
But I think that is not an argument for affirmance.

[00:15:48] Speaker 02:
One of the things that this Court has made absolutely clear, most recently in the power integrations case decided after the briefing was completed, is that this is not something for the Court to decide.

[00:16:01] Speaker 02:
This is something that the Board has to articulate in the first instance.

[00:16:04] Speaker 02:
It can't be supported on independent grounds, as Verinata repeatedly tries to do.

[00:16:10] Speaker 02:
That is simply not the law.

[00:16:12] Speaker 02:
The law, in fact, says quite the opposite.

[00:16:16] Speaker 02:
What this court said in power integrations is, as a general proposition, a review of a patentability determination is confined to the grounds on which the board actually relied.

[00:16:26] Speaker 02:
We have no warrant to accept appellate counsel's post-hoc rationalizations for agency action.

[00:16:31] Speaker 02:
Now, it may be.

[00:16:32] Speaker 02:
on remand, that the board says, there's just not enough here, and we pick apart the motivation.

[00:16:38] Speaker 02:
We pick apart the ability to combine.

[00:16:41] Speaker 02:
Although, honestly, there is nothing in the board's decision now that suggests there isn't a motivation to combine, except the absence of plug and play compatibility between Dahlin and Bin Laden.

[00:16:52] Speaker 02:
And this court made quite clear in the Mutet case that that's not the legal standard.

[00:16:56] Speaker 02:
You don't ask, can I actually plug these references together and make them work?

[00:17:01] Speaker 02:
You ask,

[00:17:02] Speaker 02:
Once people understand the knowledge in each of these references, do they have the motivation to put these things together?

[00:17:09] Speaker 02:
And if they have that motivation, would they reasonably have an expectation of success?

[00:17:13] Speaker 04:
Over my time, Your Honor.

[00:17:14] Speaker 04:
Yes.

[00:17:15] Speaker 04:
Thank you.

[00:17:15] Speaker 04:
We'll restore three minutes of rebuttal.

[00:17:17] Speaker 03:
May I just say, just generally, when I appeared in front of the Judiciary Committee for some reason, they asked me specifically if I would promise to wear my hearing aid

[00:17:31] Speaker 03:
I do, so you don't have to talk quite so loud.

[00:17:34] Speaker 04:
I apologize.

[00:17:39] Speaker 01:
Mr. Reines, may I please the court?

[00:17:42] Speaker 01:
The reason why the priority combination is so terrible is because this was such an emerging area.

[00:17:49] Speaker 01:
It's not an old area for investigation.

[00:17:53] Speaker 01:
It's emerging even as we speak.

[00:17:56] Speaker 01:
And the choices of art are not good because it's going in

[00:18:00] Speaker 01:
dissonant directions.

[00:18:02] Speaker 00:
But chew.

[00:18:02] Speaker 00:
I mean, I realize they didn't make anything of chew, but I'm very puzzled, and I would love to have some of that puzzlement be unraveled this morning.

[00:18:10] Speaker 01:
I'm here to feed and address your curiosity.

[00:18:15] Speaker 01:
Chew is random DNA sequencing with an aluminum sequencer.

[00:18:19] Speaker 01:
No one is saying that knowing how to do DNA sequencing is the invention, or even that counting is the invention.

[00:18:27] Speaker 01:
A couple of the innovations, this is a synergistic set of innovations, the characterization of the innovation as being merely multiplexing is a cartoon.

[00:18:38] Speaker 01:
I mean, it's not even, it can't be serious.

[00:18:40] Speaker 01:
One of the things they do is they reduce the sequencing, instead of doing a whole genome sequencing like Chu, where you would sequence everything, you get all your data for all 21 chromosomes, and then you go and you match it to the genome

[00:18:54] Speaker 01:
with the standard sequence alignment and you figure out how much 21 you have and then how much of a control you have.

[00:19:00] Speaker 01:
That's kind of along the two lines, okay?

[00:19:03] Speaker 01:
They do something here which is called selective enrichment where all they sequence is 21 and a control, let's say 20, just as an example.

[00:19:13] Speaker 01:
That is innovative because you're not sequencing all the other chromosomes.

[00:19:17] Speaker 01:
The cost of that is potential distortions because whenever you enrich,

[00:19:23] Speaker 01:
It's not perfect, there's biases and amplification and otherwise.

[00:19:27] Speaker 01:
When you sequence everything, you're doing that much more sequencing, 20 times the sequencing, but you don't have those errors.

[00:19:35] Speaker 01:
So to make the decision to do selective enrichment is itself a very clever idea.

[00:19:40] Speaker 01:
None of the references show that.

[00:19:42] Speaker 01:
Combining that idea with using cell free and doing the counting where you have to be so exact

[00:19:50] Speaker 01:
because there's only 10 percent fetal DNA in the cell-free region.

[00:19:55] Speaker 00:
I'm sorry, I thought I was remembering that selective enrichment appears in some of the prior art may be discussed as a way of selectively enriching those DNAs that

[00:20:11] Speaker 00:
one knows are more likely to be fetal than maternal?

[00:20:17] Speaker 00:
You're not.

[00:20:17] Speaker 01:
You're impressive in your knowledge of this technology.

[00:20:19] Speaker 00:
Is that a different kind of selective enrichment?

[00:20:20] Speaker 01:
It's completely different.

[00:20:21] Speaker 01:
That is, the old, there's so many big gulfs in these different approaches, right?

[00:20:27] Speaker 01:
Sell versus sell free.

[00:20:29] Speaker 01:
It's huge, different bodies.

[00:20:31] Speaker 01:
People have been trying to sell approach forever.

[00:20:34] Speaker 01:
In the 1990s, in a case that's before this court on the 101 issue, Dennis Lowe came up with the idea of looking to sell free region.

[00:20:40] Speaker 01:
That's the 101 issue that's big on that case.

[00:20:43] Speaker 01:
So he came up with, let's look in the cell-free.

[00:20:45] Speaker 01:
That's a huge two-body divide there.

[00:20:49] Speaker 01:
Then within looking at the cell-free region, they spent 10 years just trying to get looking at the fetal and separating the fetal out with no success at all.

[00:20:58] Speaker 01:
And they continue, people continue to try to distinguish, because if you can just get the fetal DNA, look how efficient it would be.

[00:21:04] Speaker 01:
So the selective enrichment that you're recalling is the kind of the allele

[00:21:09] Speaker 01:
in the cell-based, in Shoemaker, where you're just trying to get just the fetal DNA.

[00:21:14] Speaker 01:
It's completely different than saying, I'm going to consider the maternal and the fetal.

[00:21:20] Speaker 01:
And I think the beginning and the end of their prior art theory is in Morton's deposition.

[00:21:25] Speaker 01:
It's not even a deposition.

[00:21:26] Speaker 01:
In her report, it was one of those things, I'm not sure it was the wisest thing for them to put in from a tactical perspective, but she said,

[00:21:33] Speaker 01:
Grouping the maternal and fetal DNA together and trying to figure it out from there is a completely different problem from all the art that she just described, including their own art.

[00:21:42] Speaker 01:
And the board relied on that.

[00:21:43] Speaker 01:
This combination of priorities is terrible.

[00:21:45] Speaker 01:
I mean, they've got one person doing cell.

[00:21:48] Speaker 01:
They've got Dolin, which are trying to minimize DNA sequencing.

[00:21:52] Speaker 01:
What Dolin wants to do is say, don't do a lot of DNA sequencing.

[00:21:56] Speaker 01:
So why would you go to massive DNA sequencing like they're trying?

[00:21:59] Speaker 01:
So and then, no, I don't.

[00:22:01] Speaker 00:
But Mr. Lemley says, and tell me if this is wrong, that when you look to see what concrete problem of combination the board identified as not sufficiently established,

[00:22:23] Speaker 00:
The only one it talked about was the use of some of the amplification techniques.

[00:22:31] Speaker 00:
And that's a problem if, as the board did, it gave, you know, on page 819, gave short shrift, a highly informal term, to exhibit 1010, the aluminum brochure.

[00:22:48] Speaker 00:
Why do we not take the board's decision on its own terms?

[00:22:52] Speaker 00:
that it didn't identify with much concreteness or at all any other reasons to be uncertain about the picking and choosing of elements from these pieces of priority?

[00:23:06] Speaker 01:
I think the frustration they had, which Your Honor described earlier, of how would you even begin to pick and choose?

[00:23:12] Speaker 01:
Even in this motivation, this four lines, its conclusory, it says you take techniques from one and techniques from the other.

[00:23:19] Speaker 01:
What techniques from them?

[00:23:20] Speaker 01:
It doesn't describe anything about the techniques.

[00:23:22] Speaker 01:
With respect to 1010, the thing I want to add about 1010, because I think this is important, is with respect to 1010, they mentioned 1010 once in their discussion of the art to state that the Patent Office had granted over 1010.

[00:23:40] Speaker 01:
This is on page 179.

[00:23:42] Speaker 01:
The only reference is that the four lines from the bottom is that the Patent Office considered it and rejected it.

[00:23:47] Speaker 01:
That's their reference to 1010.

[00:23:49] Speaker 01:
Importantly, and there's an important point of procedure here, to even begin to think to remand this, because the board did an exemplary version.

[00:23:56] Speaker 01:
They said, you've given no theory how you pick from these disparate, conflicting references and put it together.

[00:24:03] Speaker 01:
How could that burden possibly be shifted to the board?

[00:24:06] Speaker 01:
That would just be unkind.

[00:24:08] Speaker 00:
But if you go to 174, what they say- I don't remember that provision of the APA.

[00:24:13] Speaker 01:
No, but just, I mean, common sense.

[00:24:15] Speaker 01:
But if you go to 174, which is their

[00:24:17] Speaker 01:
the beginning of their description and their petition that they control with their high-powered legal team and all that good stuff.

[00:24:22] Speaker 00:
What page did you cite, Senator?

[00:24:25] Speaker 00:
A174.

[00:24:25] Speaker 00:
174, yeah.

[00:24:26] Speaker 01:
They cite the regulation of the board at the last sentence, and they say the exhibit numbers of the supporting evidence relied upon to support the challenges and the relevance of the evidence that the challenge is raised, including identifying specific portions of the evidence that support the challenges are provided in Section 7 below.

[00:24:47] Speaker 01:
which is not the discussion of in section 5.

[00:24:51] Speaker 01:
And even in section 5, 1010 isn't even cited by exhibit number.

[00:24:56] Speaker 01:
It's just they say, oh, during prosecution history, it was granted over a 2008 aluminum publication, which happens to be it.

[00:25:04] Speaker 01:
And this picks up on what Judge Wallach said is, well, the first time they really raised 1010 was in the IPR reply.

[00:25:11] Speaker 01:
Wrong.

[00:25:12] Speaker 01:
That's what everyone on the team thought.

[00:25:13] Speaker 01:
I read the IPR reply.

[00:25:15] Speaker 01:
It's not in there.

[00:25:17] Speaker 01:
They doubled down on this three-ring circus of Dahlin, Bin Laden, and Schumacher in the IPR reply.

[00:25:27] Speaker 01:
They don't say, oh, wait, we've got 1010.

[00:25:29] Speaker 01:
You're forgetting 1010.

[00:25:30] Speaker 01:
How can you expect the board to take that kind of thing seriously?

[00:25:32] Speaker 01:
Now, on top of all that, the statement that they didn't consider 1010 is wrong.

[00:25:38] Speaker 01:
Professor Lemley didn't get that quite right.

[00:25:41] Speaker 01:
What they said is they were not going to tolerate

[00:25:44] Speaker 01:
a reply declaration after we put in all our submissions that attempted to substitute 1010 for Dahlin, or for whatever they were trying to substitute it for.

[00:26:00] Speaker 01:
And all they said is there's only two paragraphs of the Morton reply declaration that they weren't going to consider.

[00:26:06] Speaker 01:
That's all they said.

[00:26:07] Speaker 01:
They did not say they weren't considering 1010.

[00:26:09] Speaker 01:
This is completely different from the Randall case about which you know everything because you wrote it.

[00:26:14] Speaker 01:
Because in that case, one of the conclusions was it wasn't gonna be inconsistent with the combination.

[00:26:22] Speaker 01:
Keep in mind, let's not give the board, you know, it's a long opinion and it's well reasoned that the multiplexing that's referred to is bin Laden.

[00:26:32] Speaker 01:
They say bin Laden's the state of the art.

[00:26:35] Speaker 01:
Now they wanna say 1010, but they said, time and again, bin Laden is the best art reference on multiplexing for tagging.

[00:26:42] Speaker 01:
It would not work.

[00:26:44] Speaker 01:
with any of our approaches because it's five prime tagging.

[00:26:47] Speaker 01:
So is Shoemaker.

[00:26:49] Speaker 01:
In their reply brief, they're trying to say, well, there's no specific rejection of Shoemaker.

[00:26:52] Speaker 01:
Shoemaker works the same way.

[00:26:53] Speaker 01:
They label it the five prime end.

[00:26:55] Speaker 01:
That wouldn't work.

[00:26:57] Speaker 01:
It's another clash between their references.

[00:27:01] Speaker 00:
I mean, I guess I take it that the gist of the criticism of the board's treatment of 1010 and the general issue is something like this.

[00:27:17] Speaker 00:
The only specific thing that the board focused on as missing from the explanation, as opposed to the general characterization, you just haven't really given us much explanation about how to combine these things, is about the amplification techniques, including the whole set of amplification techniques,

[00:27:45] Speaker 00:
including the indexing and from using multiple sources and whatnot.

[00:27:50] Speaker 00:
And that really is a matter of background knowledge by the time January 2010 comes.

[00:27:59] Speaker 00:
There's really no dispute about that.

[00:28:03] Speaker 00:
I'm characterizing my understanding of their argument.

[00:28:06] Speaker 00:
There's really no dispute about that.

[00:28:08] Speaker 00:
A variety of these sources, including the petition, mention a variety of amplification techniques.

[00:28:14] Speaker 00:
There's at least indirect reference to the Illumina system using multiple sources doing it with the multiplexing.

[00:28:23] Speaker 00:
And that just wasn't taken seriously by the board when the only specific omission that the board focused on was all about that.

[00:28:33] Speaker 01:
I mean, I have so many problems with that because what the board focused on was their own admission that the difference, that the technical challenge presented by this is different than the references.

[00:28:45] Speaker 01:
Morton made that admission.

[00:28:47] Speaker 01:
There's no reason you'd do all these combinations.

[00:28:49] Speaker 01:
How does the board have, the board's saying, what are we supposed to knock down?

[00:28:52] Speaker 01:
What are you taking from Schumacher?

[00:28:54] Speaker 01:
What are you dropping?

[00:28:55] Speaker 01:
The point, Your Honor, you know that.

[00:28:57] Speaker 01:
You asked the question originally.

[00:28:59] Speaker 01:
What is, what do you actually, even in their reply brief, in their appeal, they still never tell you where do you get in selective enrichment that you're only picking, you're only sequencing two chromosomes or you're doing a chromosome comparison.

[00:29:10] Speaker 01:
Where do you even get that?

[00:29:11] Speaker 01:
And with respect to multiplexing, Dahlin eschews multiplexing.

[00:29:15] Speaker 01:
By the way, the idea that they made this as a tactical decision

[00:29:20] Speaker 01:
through craftiness because they wanted to avoid cytoprioradolin, the serential reference on fetal aneuploidy analysis, is cited right on the cover of the patent.

[00:29:29] Speaker 01:
And there's a version of Schumacher that's on there, too, for even more.

[00:29:33] Speaker 01:
So that doesn't work.

[00:29:34] Speaker 00:
So can you just get back to something I think I interrupted your answer to?

[00:29:38] Speaker 00:
What's missing from the two CHU references?

[00:29:42] Speaker 01:
In CHU, what you're doing is you're taking, you're sequencing everything in the genome.

[00:29:47] Speaker 01:
all the chromosomes.

[00:29:48] Speaker 00:
Really, there's no focus on either particular chromosomes or particular chromosomes?

[00:29:53] Speaker 00:
I'm not sure what that means, I'm sorry.

[00:29:55] Speaker 01:
This goes back to the explanation I had before, which is you go through the sequencing process, you get all the information, and then compare it against the whole genome in the sequencing alignment.

[00:30:09] Speaker 01:
And this, you do 20 less.

[00:30:12] Speaker 01:
You're feeling bad that you might be letting an invalid patent slip through, I don't think should be any concern.

[00:30:18] Speaker 01:
This patent is incredibly different.

[00:30:19] Speaker 01:
It pulls together disparate concepts.

[00:30:23] Speaker 01:
The prior art is so different because there's not good prior art out there.

[00:30:29] Speaker 01:
I mean, that's what this shows.

[00:30:31] Speaker 01:
And to blame the board for saying, we don't even know what they're saying.

[00:30:34] Speaker 01:
And in fact, I mean, their whole statement of motivation is one sentence.

[00:30:40] Speaker 01:
in their petition that's superficial and doesn't tell you.

[00:30:42] Speaker 01:
It says, well, you can combine these techniques from these three references.

[00:30:46] Speaker 01:
What techniques?

[00:30:47] Speaker 01:
And to expect the board to like parse that down.

[00:30:50] Speaker 01:
And with respect to your statement, your honor, Bin Laden was selected purely for saying how you do the tagging.

[00:30:57] Speaker 01:
I think we can all agree with that.

[00:30:59] Speaker 01:
There's no room to wiggle around.

[00:31:01] Speaker 01:
How can you replace that with some kind of background knowledge about a general concept?

[00:31:08] Speaker 01:
and say, OK, we're going to push out that whole current state of the art, their selected reference, by something that's background knowledge with no real analysis as to why people would pick that.

[00:31:19] Speaker 01:
Dahlin is trying to minimize sequencing.

[00:31:22] Speaker 01:
He's not moving to massively parallel sequencing.

[00:31:28] Speaker 01:
And more to the point, when you add tags, that's more sequence.

[00:31:35] Speaker 01:
Dahlin wants to sequence one nucleotide, right, a SNP, a polymorphism, so he can figure out, is it mother, is it father, do we have an extra, you know, a second one, right?

[00:31:46] Speaker 01:
He wants to minimize that.

[00:31:47] Speaker 01:
He's going to all these troubles.

[00:31:48] Speaker 01:
Why would he add a 12-base tag and massively increase the amount of sequence he has to do when he's trying to reduce sequencing?

[00:32:00] Speaker 01:
It's a terrible combination that had no rationale up through their appeal brief of what you're pulling from where to get there.

[00:32:07] Speaker 01:
The board acknowledged that.

[00:32:08] Speaker 01:
And with the tagging, it's like, and your tagging argument's terrible because it wouldn't work with the invention.

[00:32:15] Speaker 01:
Because in order to do the DNA test that you're suggesting for Dolan, you'd have to chop off the tag.

[00:32:22] Speaker 01:
And the fact that they have a reference in there that's still trying to do cell-based analysis tells you how far afield they had to go.

[00:32:31] Speaker 04:
Final thought?

[00:32:34] Speaker 01:
Thank you for traveling to Boston and allowing the law schools to see these kind of arguments.

[00:32:38] Speaker 01:
And I very much appreciate your consideration of the matter.

[00:32:55] Speaker 00:
Does CHU do front-end selection of particular chromosome regions to do sequencing on, or does it do some much larger scale sequencing?

[00:33:09] Speaker 00:
I don't know the answer to that.

[00:33:09] Speaker 00:
Or what's wrong with that question?

[00:33:10] Speaker 02:
I don't know the answer.

[00:33:12] Speaker 02:
Well, what's wrong with the question, frankly, is that it's not something that was before the board.

[00:33:16] Speaker 02:
And let me actually bring that.

[00:33:19] Speaker 02:
I actually meant something.

[00:33:20] Speaker 00:
whether there was something technically wrong with it.

[00:33:22] Speaker 02:
No, no.

[00:33:24] Speaker 02:
So I will say the claim is a little ambiguous.

[00:33:26] Speaker 02:
Claim one is a little ambiguous on whether it is limited to a particular chromosome.

[00:33:30] Speaker 02:
It makes reference to a single chromosome and a reference chromosome, but it also uses the word comprising.

[00:33:36] Speaker 02:
So even if Chu covers the entire genome rather than one chromosome, it's not obvious that the claim is limited in a way that would distinguish it from Chu.

[00:33:45] Speaker 02:
But let me focus, though, on the language from power integrations that I cited earlier, right?

[00:33:54] Speaker 02:
We have no warrant, this court said, to accept appellate counsel's post-hoc rationalizations for agency action.

[00:34:00] Speaker 02:
You heard a lot of discussion of the science and Mr. Reinus's theory that this was a bad combination of references and the science is different in various respects.

[00:34:09] Speaker 02:
You will find none of that in the board's opinion, none.

[00:34:12] Speaker 02:
his new theory on this argument that selective enrichment wasn't taught anywhere.

[00:34:16] Speaker 02:
That's wrong.

[00:34:17] Speaker 02:
The board, in its initiation decision, found that Schumacher taught selective enrichment.

[00:34:23] Speaker 02:
That's A-71.

[00:34:24] Speaker 02:
Bin Laden taught selective enrichment.

[00:34:26] Speaker 02:
That's A-1359.

[00:34:28] Speaker 02:
But more importantly, it's irrelevant.

[00:34:30] Speaker 02:
The board did not make any of the conclusions that Mr. Reinus is now offering.

[00:34:35] Speaker 02:
The argument that he makes is replete with references to things that the board simply didn't find, and that's not appropriate under Chenery.

[00:34:46] Speaker 02:
And I think the appropriate thing for this court to do is to remand and to say, if you are in fact persuaded that this is a bad combination of references and it can't teach us what we need, give us a set of findings that shows us that.

[00:35:02] Speaker 02:
But what they have done now is not to pay any attention to the evidence of skill in the art.

[00:35:09] Speaker 02:
The Nussbaum declaration was quite clear upfront at the initiation of the petition that, quote, multiplexing was so widespread as a technique that the company Illumina offered a commercially available kit for production and analysis of index libraries.

[00:35:24] Speaker 02:
This kit enabled the sequencing of 96 different samples on a single flow cell and was designed to be used with their multiplex sequencing platform, the Illumina Genome Analyzer.

[00:35:34] Speaker 02:
This is in the record at 876.

[00:35:35] Speaker 02:
So as a molecular geneticist in 2008, I would have had the ability to order a commercially available kit for the production of these libraries, which I could have analyzed on a commercially available massively parallel sequencing platform sold by the same vendor.

[00:35:50] Speaker 02:
Now, it is simply not the case that this wasn't before the board.

[00:35:54] Speaker 02:
It was before the board in the petition.

[00:35:56] Speaker 02:
It was before the board because it was cited in their own patent.

[00:35:59] Speaker 02:
It was before the board because in their initiation decision, they make affirmative reference to it.

[00:36:04] Speaker 02:
To suggest that they can somehow ignore Illumina after the fact by saying it was discussed only in the reply, I think, is frankly, improper.

[00:36:14] Speaker 04:
Thank you.

[00:36:15] Speaker 04:
Thank you, Your Honor.

[00:36:15] Speaker 04:
We thank both counsel.

[00:36:16] Speaker 04:
The case is submitted.

[00:36:18] Speaker 04:
And that concludes our proceedings for this morning.

[00:36:22] Speaker ?:
All rise.

[00:36:48] Speaker 04:
The Honorable Court is adjourned until this afternoon at 2 p.m.