[00:00:00] Speaker 03:
Our next case is Illumina in Secrinom versus Ariosa Diagnostics and Roche Sequencing, 2019-14-19.

[00:00:11] Speaker 03:
Mr. Reinus.

[00:00:15] Speaker 00:
May it please the Court, Your Honor.

[00:00:17] Speaker 00:
The District Court improperly found patent-ineligible an innovative method to create an unnatural preparation of enriched fetal DNA.

[00:00:27] Speaker 00:
using human-engineered size filtering that balances competing considerations.

[00:00:33] Speaker 00:
And the problem with the district court's analysis is that the claims are directed clearly to those thresholds.

[00:00:44] Speaker 00:
That's clearly what's innovative in the claims, and it's clearly what the inventions are about.

[00:00:51] Speaker 04:
When is it that you say the claims are directed to?

[00:00:54] Speaker 00:
To my analysis, Your Honor, they're directed to the filtering thresholds for creating an enriched DNA preparation.

[00:01:05] Speaker 04:
Field clean thresholds.

[00:01:07] Speaker 04:
Is that in the panel?

[00:01:09] Speaker 00:
Yes, the claim would be to the step of selectively eliminating above 500 in the case of the 751 patent, 500 base pairs are greater, or in the case of the 93 patent, 300 base pairs are greater.

[00:01:27] Speaker 04:
a mixture of DNA and then... Is it directed to the process of that separation?

[00:01:33] Speaker 04:
It's a method, yes, clearly a method and it's a... That's what you're saying the claims are directed to, the method of separation.

[00:01:42] Speaker 00:
The method of taking a mixed sample and separating, not separating, but selectively, it's not really a separation in my mind, it's selectively removing.

[00:01:50] Speaker 04:
Mixed sample is a sample of blood from a pregnant woman.

[00:01:53] Speaker 00:
It would include fetal and maternal DNA.

[00:01:55] Speaker 04:
Right, so that's your sample.

[00:01:57] Speaker 04:
And you're saying that the claims are directed to separating from their fragments of DNA that are less or greater than 500 base pairs?

[00:02:08] Speaker 00:
Separating isn't the clearest way to say it.

[00:02:09] Speaker 00:
I think it's really removing.

[00:02:11] Speaker 00:
Removing.

[00:02:11] Speaker 00:
Because you're not then doing something with it.

[00:02:13] Speaker 04:
So basically you're removing out of that sample all of the- Larger.

[00:02:17] Speaker 04:
Maternal.

[00:02:18] Speaker 00:
No, that's the point.

[00:02:20] Speaker 00:
The point here is that there is no one point of size where if it's greater than 500, it's all maternal.

[00:02:29] Speaker 00:
If it's less than 500, it's all fetal.

[00:02:31] Speaker 00:
It's not that simplistic.

[00:02:32] Speaker 03:
Mr. Reines, isn't your point that this is a method of manufacture?

[00:02:38] Speaker 00:
It is manufacturing a preparation.

[00:02:39] Speaker 03:
The claim itself says it's a method of preparing a DNA fraction.

[00:02:43] Speaker 00:
Yes.

[00:02:44] Speaker 00:
Yes, Your Honor.

[00:02:45] Speaker 01:
and and and the point is that your claim is properly described as directed to a method of creating a tool which could later be used in a diagnostic process but the claim itself is directed to creating a tool like a spectographer or anything else that might be used in a process I think you're right your honor and that tool apparently is a fraction right the tool is a method is a preparation of enriched

[00:03:15] Speaker 00:
DNA that contains more fetal.

[00:03:17] Speaker 00:
But the point I want to make, because I want to address something that Judge Raina, you made a good point, which is, is 500 the dividing line between everything above 500 is the maternal DNA and everything below 500 is the fetal DNA?

[00:03:28] Speaker 00:
And that's not the case.

[00:03:30] Speaker 00:
As table one shows, there's dramatically different ratios.

[00:03:35] Speaker 04:
Let me direct your attention to the appendix.

[00:03:40] Speaker 04:
It's 31.

[00:03:46] Speaker 04:
and column one around line 55.

[00:03:51] Speaker 04:
So we're looking there and it's talking about this surprising discovery, correct?

[00:03:56] Speaker 00:
That's correct, Your Honor.

[00:03:57] Speaker 04:
And it goes on and it refers to fetal DNA and it refers to the size, 500 base pairs or less, whereas it goes on and talks about greater than or less than the 500 base pairs

[00:04:10] Speaker 04:
And maternal circulation has been found to be smaller.

[00:04:14] Speaker 04:
There again, we're talking about the maternal.

[00:04:17] Speaker 04:
It keeps going on to column two.

[00:04:19] Speaker 04:
And it says, so far, that's not your discovery.

[00:04:24] Speaker 00:
Well, it's identifying thresholds.

[00:04:27] Speaker 00:
So I mean, I don't know.

[00:04:29] Speaker 04:
OK, if it's identifying thresholds, then I'll come back to that.

[00:04:32] Speaker 04:
Let's look on to the following column.

[00:04:36] Speaker 04:
It says, is this surprising finding

[00:04:38] Speaker 04:
which I agree, it's a great finding, it's a great discovery there.

[00:04:45] Speaker 04:
But let's see now if that discovery is worthy of pending.

[00:04:50] Speaker 04:
It says, it forms the basis of the present invention.

[00:04:55] Speaker 04:
So I take it that what I've read before is the basis of the present invention.

[00:05:03] Speaker 00:
You read a whole paragraph that's a lot of sentences, but yes.

[00:05:07] Speaker 04:
OK, good.

[00:05:09] Speaker 04:
Then it goes on, and it deals with a selective enrichment.

[00:05:14] Speaker 04:
And it goes to the point I'm coming to.

[00:05:17] Speaker 04:
It just leads to a fraction, which is largely constituted.

[00:05:22] Speaker 04:
And it's getting to that point that is what you call

[00:05:30] Speaker 04:
adjusting the pool or finding my size, this particular DNA.

[00:05:35] Speaker 04:
This is a fraction of the pool of the mother sample, of the original sample.

[00:05:41] Speaker 04:
Yes.

[00:05:42] Speaker 04:
You're getting to a fraction of that.

[00:05:44] Speaker 04:
So what is it that the claims are directed to?

[00:05:46] Speaker 04:
The process to get to the fraction?

[00:05:48] Speaker 00:
Well, I mean, there's been different articulations, and I embrace those.

[00:05:52] Speaker 04:
The articulation I'm pointing to is in the frame itself.

[00:05:56] Speaker 00:
I think it's clearly directed to selecting a size point

[00:06:02] Speaker 00:
and uses the language and the claims.

[00:06:03] Speaker 00:
I'm not re-changing that, but let's say, for example, 500 uses approximately.

[00:06:08] Speaker 00:
And it's saying that's a good point from a human engineering, there's a human engineering judgment made that that's the point where you keep enough fetal, you increase the fetal enough, but you're not eliminating so much DNA that you don't have anything left.

[00:06:23] Speaker 03:
And how is it done, Mr. Reines?

[00:06:25] Speaker 03:
How is it done?

[00:06:27] Speaker 03:
This is a method.

[00:06:29] Speaker 03:
What does the method consist of?

[00:06:31] Speaker 03:
Not just the result, but the steps.

[00:06:35] Speaker 00:
The steps are obviously laid out in the claim, but they include taking the original sample, extracting the DNA,

[00:06:43] Speaker 00:
producing the faction by size, discrimination, and a selective removal step, which can be done any number of ways.

[00:06:49] Speaker 00:
One of the ways of doing this, by the way, is through a microarray that's claim 11 of the 931 patent that has never been done, the evidence in the record.

[00:07:00] Speaker 00:
So there's summary judgment problems with that.

[00:07:02] Speaker 03:
What does microarray consist of?

[00:07:06] Speaker 00:
Is that a process?

[00:07:07] Speaker 00:
It's a tool that's used in a process.

[00:07:12] Speaker 03:
I'm looking at claim seven, and that to me comprises a process, centrifugation.

[00:07:21] Speaker 03:
Maybe that is how you separate these and make and prepare this fraction of DNA.

[00:07:30] Speaker 00:
That's one way to do it, yes.

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

[00:07:33] Speaker 04:
But the point I want to make... Just to be clear, you didn't invent that process.

[00:07:40] Speaker 00:
Yeah, one claim step isn't the invention.

[00:07:43] Speaker 00:
The invention is the overall.

[00:07:45] Speaker 04:
That particular claim step was not invented.

[00:07:47] Speaker 04:
That's not your invention.

[00:07:49] Speaker 00:
You said refuges are not the invention.

[00:07:51] Speaker 04:
In fact, the pen teaches us that that's kind of well known.

[00:07:54] Speaker 00:
Well, applied to cell-free DNA, the record is to the contrary as to some of the steps, and for example, the microarray.

[00:08:02] Speaker 00:
The microarray, cell-free DNA tends to be smaller, and using a microarray was unknown at the time.

[00:08:08] Speaker 00:
And there's Dr. Stachowski testified to that, and that's set out in my briefs and not disputed.

[00:08:14] Speaker 00:
So yes, with respect to some of the steps, clearly it's innovative to have applied particular tools to the sample in the way that they did.

[00:08:21] Speaker 04:
But I do want, Judge Rein, I... When you discriminate amongst the DNA.

[00:08:28] Speaker 00:
Right.

[00:08:29] Speaker 04:
In order to get the size sample that you want of the prenatal DNA.

[00:08:38] Speaker 04:
What, how do you do that?

[00:08:40] Speaker 04:
How do you get to that?

[00:08:41] Speaker 00:
You can do that in different ways.

[00:08:43] Speaker 00:
You can use electrophoresis.

[00:08:45] Speaker 00:
You can use a centrifuge.

[00:08:47] Speaker 00:
There's different techniques that can be used that haven't been applied necessarily to cell-free DNA.

[00:08:51] Speaker 00:
This was the infancy.

[00:08:53] Speaker 04:
But your claim or your invention, the claims are not directed to centrifuging or those other steps.

[00:09:02] Speaker 00:
Well, I think that's incorrect in terms of inventive contribution for certain dependent claims.

[00:09:08] Speaker 04:
I'm not saying that your claims don't mention it.

[00:09:10] Speaker 04:
I said your claims are not directed to that.

[00:09:12] Speaker 04:
That's not what you mean.

[00:09:14] Speaker 00:
But there's a dependent claim that adds the concept, for example, of using a microarray with respect to cell-free DNA, for which there's no precedent.

[00:09:22] Speaker 00:
Which claim is that?

[00:09:24] Speaker 00:
That is claim 11 of the 931 patent.

[00:09:28] Speaker 00:
And the evidence that that was unknown is at 263.

[00:09:45] Speaker 03:
Mr. Reinus, it's not determined, of course, but do these patents derive from the earlier sycmanome patent that was the subject of a major decision?

[00:09:57] Speaker 00:
No, it's a different family.

[00:09:59] Speaker 00:
But the point I want to make, Judge Reina, that I really don't think I've communicated effectively yet, is in Table 1,

[00:10:07] Speaker 00:
The mixture as to what's fetal and what's maternal, every sample is seemingly different.

[00:10:13] Speaker 00:
So, for example, on table one, it says that in one sample, it was below 300 base pairs was 22% fetal DNA.

[00:10:23] Speaker 00:
For another sample, it was 87% fetal DNA.

[00:10:28] Speaker 01:
So Mr. Reinus, are you saying, I'm sorry, I'm going to jump ahead.

[00:10:33] Speaker 01:
I should let you finish.

[00:10:33] Speaker 00:
That's okay.

[00:10:34] Speaker 00:
No, please.

[00:10:35] Speaker 01:
I think what I understand you to be saying is this claim might be different if it just said separate out all maternal DNA from fetal DNA, setrefusion, whatever.

[00:10:46] Speaker 01:
But there was actually a point of innovation in selecting the number 300 and the number 500.

[00:10:53] Speaker 01:
And the reason that point of innovation is not just flow from the idea that maternal strands are longer, it also incorporated a lot of back and forth testing in advance to assess how do we maximize the amount of fetal DNA in a given sample.

[00:11:12] Speaker 01:
Every sample is different and there are a lot of factors that go into it.

[00:11:14] Speaker 01:
And so from an engineering standpoint, how do we pick a number that's not necessarily all fetal DNA, but keeps us with a sample big enough to actually then later allow for diagnostic tools to figure out what they want?

[00:11:27] Speaker 00:
That's correct.

[00:11:28] Speaker 01:
So it's not the correlation between longer and shorter.

[00:11:32] Speaker 01:
It's the engineering of keeping in mind that correlation.

[00:11:36] Speaker 01:
How do we choose sort of a perfect number that is going to work the best with diagnostic tests that people need because they've got to have a big enough sample that includes enough of the fetal DNA?

[00:11:46] Speaker 00:
That is very articulately put.

[00:11:48] Speaker 01:
Because there's surely fetal DNA that exceeds 300 base pairs.

[00:11:51] Speaker 01:
And there's surely maternal DNA that's less than 300 base pairs.

[00:11:54] Speaker 00:
It's totally overlapping, and it's different sample to sample, and it's different application to application.

[00:12:01] Speaker 04:
And that's the startling discovery that's mentioned in the panel.

[00:12:07] Speaker 04:
No.

[00:12:08] Speaker 04:
i don't think that you know i believe the startling bit with the startling thing you just mentioned i find to be to be uh... disclosed in the summary of invention portion what you and i walked away through their india there it describes the different sizes of the strength no because those are not the point is that those that the three hundred five hundred are not any kind of natural law

[00:12:34] Speaker 00:
They're a human engineering judgment.

[00:12:36] Speaker 04:
The stunning discovery... The human did not engineer those different sizes.

[00:12:40] Speaker 04:
Those different sizes already exist.

[00:12:42] Speaker 04:
You just found them.

[00:12:43] Speaker 00:
No, that's where it's so untrue.

[00:12:46] Speaker 00:
That is not correct, Judge Randall.

[00:12:47] Speaker 00:
Let me just have a minute to express that.

[00:12:49] Speaker 00:
The discovery, and I think this is undisputed, is that in general, maternal DNA is larger than fetal DNA.

[00:12:58] Speaker 00:
That's, I don't think there's ambiguity.

[00:13:00] Speaker 04:
It actually uses the size, 500 greater than, less than.

[00:13:04] Speaker 00:
Because you could pick any, you could pick different ranges or different points to say, okay, we want to get, keep some of the fetal DNA, but we don't, and make it more enriched, but we don't want to make our sample so small.

[00:13:17] Speaker 00:
So there's engineering decisions that need to be made depending on your nature of your test.

[00:13:24] Speaker 04:
That's human judgment.

[00:13:25] Speaker 04:
I want to focus on this engineering because

[00:13:27] Speaker 04:
I want to make sure you're not claiming that somebody engineered these sizes or the size differences.

[00:13:36] Speaker 04:
That is already naturally occurring.

[00:13:38] Speaker 00:
They're varied from person to person, no.

[00:13:41] Speaker 00:
But what the good point is to use across all samples.

[00:13:44] Speaker 04:
Nobody invented those size differences.

[00:13:49] Speaker 00:
Nobody invented that there's a tendency.

[00:13:52] Speaker 00:
But what the number is to divide it at is a human judgment as to where you want to make the breakpoint to balance competing considerations in different contexts, it may be different.

[00:14:04] Speaker 00:
That's the point.

[00:14:05] Speaker 00:
Their own witness, Dr. Stotowski said, well, where you set that number depends on what you're doing and how you want to do it.

[00:14:12] Speaker 00:
longer DNA for some purpose.

[00:14:13] Speaker 00:
So you may want to just make it 700 or 1,000, or you may want to get rid of so much of the maternal DNA because you're crazy to get rid of it all.

[00:14:22] Speaker 00:
And you make it one or 10.

[00:14:24] Speaker 00:
So there's judgments that are just part of the process.

[00:14:27] Speaker 00:
And they're not a natural law.

[00:14:29] Speaker 00:
They are not.

[00:14:30] Speaker 03:
Counsel, you're just about to run your time.

[00:14:33] Speaker 03:
We'll give you two minutes for rebuttal.

[00:14:36] Speaker 03:
Thank you, sir.

[00:14:36] Speaker 03:
Ms.

[00:14:36] Speaker 03:
Drury?

[00:14:39] Speaker 02:
Thank you, Your Honors, and may it please the Court, Daryl and Dury, for appellees.

[00:14:44] Speaker 02:
The specification here describes the invention as being directed to the supposed discovery of this size variation in DNA fragments.

[00:14:54] Speaker 02:
And if we take a look at Claim 1 of the 9-3 patent at Appendix 42, it is a method

[00:15:02] Speaker 02:
comprising, extracting DNA, producing a fraction, selectively removing longer fragments, and then analyzing the DNA fragments that remain in the fraction.

[00:15:15] Speaker 03:
But it recites a method of preparing a DNA fraction.

[00:15:19] Speaker 03:
Now, whether it's obvious or not,

[00:15:24] Speaker 03:
or whether it's well supported in 112 cents.

[00:15:28] Speaker 03:
The question here is 101.

[00:15:30] Speaker 03:
Correct.

[00:15:31] Speaker 03:
Is it the type of claim, type of subject matter that falls within eligible classes of subject matter?

[00:15:41] Speaker 03:
Now, this is a process, right?

[00:15:43] Speaker 03:
It doesn't claim in the natural law.

[00:15:46] Speaker 02:
It is a process in precisely the same way that the claim in Ariosa versus Sequinome was a process.

[00:15:54] Speaker 03:
Well, that was simply amplifying and analyzing.

[00:15:57] Speaker 02:
It was obtaining a fraction, amplifying certain of the DNA in that fraction to change... Well, obtaining a fraction is sort of a useless kind of...

[00:16:08] Speaker 03:
step in a method claim.

[00:16:10] Speaker 03:
It simply is equivalent to starting with something.

[00:16:13] Speaker 02:
Correct.

[00:16:14] Speaker 03:
And then the steps are amplifying and analyzing.

[00:16:18] Speaker 02:
Right.

[00:16:18] Speaker 02:
And here, the only difference is that instead of amplifying, we have separating.

[00:16:24] Speaker 02:
That's a step.

[00:16:26] Speaker 03:
That's a physical step.

[00:16:28] Speaker 02:
So amplifying is a physical step.

[00:16:30] Speaker 02:
It changes the composition of the pool of DNA.

[00:16:35] Speaker 02:
Separating is a physical step.

[00:16:37] Speaker 02:
It likewise changes the composition of that pool by removing certain things from it.

[00:16:42] Speaker 02:
But there's a long line of precedent that simply removing one natural material from its environment and then analyzing it is not patent eligible.

[00:16:51] Speaker 02:
And that's all that is claimed here.

[00:16:54] Speaker 02:
Now, we heard a lot about the supposed human ingenuity in identifying these 300 base pair and 500 base pair numbers that appear here.

[00:17:02] Speaker 03:
Well, that's sort of puffery.

[00:17:04] Speaker 03:
We're not really talking about non-obviousness.

[00:17:07] Speaker 03:
The question here is eligibility.

[00:17:10] Speaker 02:
That's right, and Illumina is trying to rest on the supposed human ingenuity in those 300 and 500 numbers as giving rise to eligibility.

[00:17:22] Speaker 02:
And I just want to make clear, nothing in the specification suggests that those numbers result from human ingenuity.

[00:17:29] Speaker 02:
They result from the conventional technology that was used to perform

[00:17:34] Speaker 02:
the original test itself.

[00:17:37] Speaker 02:
This is appendix 41, column 5 of the 931 patent.

[00:17:42] Speaker 02:
What we see is that the ladders that were used to analyze the size of the DNA fragments cut off at 300 and cut off at 500 because of the conventional technology that was used.

[00:17:53] Speaker 02:
All the patent then says is, if you want a sample that is enriched for fetal DNA, you're going to choose the fraction that is smaller than 300 or the fraction that is smaller than 500.

[00:18:04] Speaker 02:
because in the results that are set forth in Table 1, as a matter of the natural phenomenon, those are the fractions that have more fetal DNA in them.

[00:18:14] Speaker 02:
What our witness said in her deposition was, of course, depending on what you want to do, you might choose a different fraction.

[00:18:20] Speaker 02:
If you're enriching from maternal DNA, for example, you would choose a larger one.

[00:18:24] Speaker 02:
That doesn't detract, Adrena, from your point that the amount of fetal versus maternal DNA in any given fraction simply is the natural phenomenon that the inventors here purport to have discovered as the basis for their invention.

[00:18:38] Speaker 02:
There is no description of any human ingenuity whatsoever in arriving at any special way to take advantage of that phenomenon.

[00:18:47] Speaker 02:
Instead, what there is are concededly routine steps to do nothing more than analyze the DNA that's in that sample having removed some of it.

[00:18:57] Speaker 03:
Once again, we're talking about eligibility.

[00:18:59] Speaker 03:
Correct.

[00:19:00] Speaker 03:
Most chemical process steps are routine.

[00:19:03] Speaker 03:
There are very few and rare new process steps.

[00:19:09] Speaker 03:
The method of making a material consists of old process steps.

[00:19:18] Speaker 03:
And they may not be non-obvious.

[00:19:21] Speaker 03:
They may not be well supported under 112.

[00:19:24] Speaker 03:
But once again, they are physical, tangible steps.

[00:19:29] Speaker 03:
And we're talking about eligibility.

[00:19:31] Speaker 02:
as was the case in Ariosa, as was the case in Cleveland Clinic, as was the case in a number of this court's precedents addressing the eligibility of method claims.

[00:19:43] Speaker 02:
Here, we start with a composition of natural material.

[00:19:47] Speaker 02:
We end with a composition of natural material.

[00:19:50] Speaker 02:
All that we do in between is separate some of it from the other and analyze it in this entirely unspecified fashion.

[00:19:58] Speaker 02:
So at the level of step one, what are the claims directed to?

[00:20:02] Speaker 02:
They are directed to nothing more than the size variation within the pool of DNA.

[00:20:07] Speaker 02:
At the level of step two, are there any innovative techniques or new and non-conventional techniques that are being used in that method?

[00:20:16] Speaker 02:
The answer to that question is no.

[00:20:18] Speaker 02:
The only thing that we heard specific reference to was the use of these nucleic acid arrays.

[00:20:25] Speaker 02:
That is described in column three of the 931 patent, beginning around line 35.

[00:20:32] Speaker 02:
All that the patent says about the use of these arrays is that the determination of fetal genetic traits can be affected by methods such as, for example,

[00:20:42] Speaker 02:
PCR technology, ligase chain reaction, probe hybridization, nucleic acid arrays, and the like.

[00:20:50] Speaker 02:
There is no suggestion in the specification that that's not simply routine and conventional technology, and very notably here because this was summary judgment and not a motion to dismiss.

[00:21:01] Speaker 02:
Illumina had the opportunity to put in expert testimony contesting the proposition that that is routine and conventional technology and elected not to do so.

[00:21:11] Speaker 02:
We had shifted the burden to them by pointing to that disclosure in the specification.

[00:21:16] Speaker 02:
There's simply no evidence in the record to support the proposition that that's not routine.

[00:21:21] Speaker 02:
All our witness said was she was unaware of the use of that technology specifically in this technological context to look at cell-free DNA.

[00:21:29] Speaker 02:
But that's not the right question.

[00:21:30] Speaker 02:
The question is, is it routine more generally in the context of DNA analysis?

[00:21:34] Speaker 04:
Another question could be, is there an improvement

[00:21:37] Speaker 04:
on those routine or conventional steps?

[00:21:40] Speaker 04:
And does this patent show that there's any type of improvement?

[00:21:44] Speaker 02:
And the answer to that question is no.

[00:21:45] Speaker 02:
There is nothing in the patent specification that suggests that this improves over conventional technology.

[00:21:51] Speaker 02:
What it says is that it makes use of conventional technology.

[00:21:54] Speaker 02:
The only thing that is different is that it is using that conventional technology to analyze this DNA sample based on size differences.

[00:22:04] Speaker 02:
Now, we can test that that's new, but even if it is, that's the natural phenomenon at issue.

[00:22:10] Speaker 02:
And this court's precedent and the Supreme Court's precedent is clear that you can't import into step two alleged novelty from the supposed natural phenomenon itself.

[00:22:20] Speaker 03:
What if this claim read a method

[00:22:24] Speaker 03:
of separating DNA so that base pairs are greater than 500 from those that are less, consisting of centrifuging them.

[00:22:36] Speaker 03:
Would that pass muster under 101?

[00:22:39] Speaker 02:
No, Your Honor.

[00:22:40] Speaker 02:
And that's because what matters for purposes of 101 in step one is the substantive gist of what the claim is directed to and not merely the language that is used to describe that substance.

[00:22:52] Speaker 03:
But that's what

[00:22:54] Speaker 03:
Patent law is all about.

[00:22:55] Speaker 02:
So I would suggest language matters a great deal in patent law, but it matters to the extent that it describes salient differences.

[00:23:04] Speaker 02:
And in Cleveland Clinic, this court was presented with that linguistic question and said, that distinction is too superficial.

[00:23:12] Speaker 02:
This is not merely a task of looking at the words.

[00:23:15] Speaker 02:
It is a task of looking at the words mean.

[00:23:18] Speaker 03:
What was involved in Cleveland Clinic?

[00:23:22] Speaker 03:
Detecting a natural material?

[00:23:25] Speaker 02:
So that's right.

[00:23:25] Speaker 02:
Exactly what is at issue here, analyzing a natural material, which pursuant to Claim 12 includes detection as one potential form of analysis.

[00:23:35] Speaker 02:
So all in substance the claim here is directed to is natural material, get rid of some of it, look at what remains, where detection is one permissible form of analysis.

[00:23:47] Speaker 03:
But if you have a mixture of things, which because it's a mixture is not practically useful.

[00:23:55] Speaker 03:
and you separate the mixture into two portions, which makes one of them practically useful.

[00:24:02] Speaker 03:
That doesn't pass 101, must it?

[00:24:06] Speaker 02:
It does not.

[00:24:07] Speaker 02:
If you present me with a pond with material floating in it, and I strain the pond in order to extract the material, the natural material that is sitting there and is useful,

[00:24:18] Speaker 02:
Unless there is something novel about my practice of extraction, the answer to that question is no.

[00:24:23] Speaker 02:
As the court had on Marriott, simply removing something from its natural environment does not confer 101 eligibility.

[00:24:32] Speaker 02:
And that is the only thing that's happening here.

[00:24:33] Speaker 02:
Notably, those are the identical steps that Illumina undertook.

[00:24:38] Speaker 01:
Didn't Marriott, the Supreme Court, make it clear they weren't deciding whether it applied to process claims?

[00:24:42] Speaker 01:
They were only deciding that it applied to actual substance claims?

[00:24:46] Speaker 01:
So I agree that the claims at issue in the Supreme Court's decision in Myriad were — No, and don't you agree that the Supreme Court expressly said they're not speaking to what would happen with regard to process claims?

[00:24:56] Speaker 02:
I agree.

[00:24:57] Speaker 02:
But there is no logical distinction between a composition of matter claim directed to that thing which has been extracted and a method claim that encompasses as a step the extraction if there is no novelty that is associated with that method.

[00:25:14] Speaker 01:
Certainly, as the Court and Marriott said... I feel like you're turning 101 into a novelty assessment.

[00:25:22] Speaker 01:
I don't understand.

[00:25:23] Speaker 01:
101 is 101.

[00:25:24] Speaker 01:
It's not an assessment of what the... I mean, you're saying if the gist of the invention isn't novel.

[00:25:30] Speaker 01:
I mean, gosh darn, that was the rejected old 103 via Hotchkiss.

[00:25:34] Speaker 01:
But now you want to import what Compass expressly rejected as part of the patent system into 101 and give it new life.

[00:25:43] Speaker 02:
No.

[00:25:44] Speaker 02:
What I want to do, Your Honor, is focus at step one on what is the gist of the invention.

[00:25:50] Speaker 02:
And in cases like Ariosa, this Court has- What is the gist of the invention?

[00:25:53] Speaker 01:
I thought it's what is-

[00:25:55] Speaker 02:
The claim directed to.

[00:25:57] Speaker 02:
Correct.

[00:25:58] Speaker 02:
That is not what is the gist of the invention.

[00:26:01] Speaker 02:
What is the claim directed to?

[00:26:02] Speaker 02:
In Ariosa, where the claim was a method claim.

[00:26:06] Speaker 02:
It was a diagnostic claim.

[00:26:08] Speaker 01:
It was a method for... Was it a diagnostic claim?

[00:26:11] Speaker 02:
It was a method for performing a diagnosis.

[00:26:13] Speaker 01:
Yes or no?

[00:26:13] Speaker 01:
Was it a diagnostic claim?

[00:26:15] Speaker 02:
Yes.

[00:26:16] Speaker 02:
Are these diagnostic claims?

[00:26:17] Speaker 02:
So this is simply a method.

[00:26:20] Speaker 02:
unspecified.

[00:26:22] Speaker 01:
So if we take a look at claim... I'll accept that as a no, this is not a diagnostic claim.

[00:26:27] Speaker 02:
Well, I would suggest the fact that in ARIOSA it said a method for performing a prenatal diagnosis and here in the 931 patent it simply says a method comprising

[00:26:37] Speaker 02:
is not a substantial difference.

[00:26:39] Speaker 02:
The claim in Arioso was more specific.

[00:26:41] Speaker 02:
I agree.

[00:26:42] Speaker 02:
The claim at issue here is more general.

[00:26:45] Speaker 02:
But the steps of that method claim are indistinguishable as between the two.

[00:26:50] Speaker 02:
Taney?

[00:26:51] Speaker 04:
Let's get away from the jest of the claims.

[00:26:56] Speaker 04:
Instead, go back and look at what this court has consistently

[00:27:05] Speaker 04:
asked in terms of step one of the 101 inquiry, and that is, what is the focus – and I'd like for Mr. Ryan to answer this question – what is the focus of the claimed advance for the priority?

[00:27:18] Speaker 04:
That's something that we have said in a number of cases, at least eight that I know of, that is to answer the question, what are the claims directed to?

[00:27:30] Speaker 02:
That is right.

[00:27:30] Speaker 02:
This court has consistently looked at the patent specification in order to answer that question.

[00:27:36] Speaker 02:
And here, the patent specification says that the invention is predicated on the surprising discovery of the difference in size of fragments of maternal and fetal DNA.

[00:27:46] Speaker 02:
There is nothing else that is described in the patent specification.

[00:27:50] Speaker 01:
I don't understand how a claim to 300 base pairs and a claim to 500 base pairs can both be covering the, quote, natural law.

[00:27:57] Speaker 02:
Because the natural law is the size distribution of fragments.

[00:28:01] Speaker 02:
As a matter of the natural phenomenon, some fragments are lower than 300, and some fragments are lower than 500.

[00:28:08] Speaker 02:
And when Illumina used conventional technology to cut the DNA up into chunks of various sizes, some of those sizes were under 300, some were between 300 and 500, and it evaluated that.

[00:28:21] Speaker 02:
That is simply an evaluation of the range of fragment sizes that appear

[00:28:26] Speaker 02:
in the human body.

[00:28:28] Speaker 02:
There is then, obviously, a question of... The natural law is what?

[00:28:33] Speaker 02:
State it for me.

[00:28:34] Speaker 02:
The natural phenomenon is the size distribution of maternal and fetal DNA fragments.

[00:28:41] Speaker 01:
Okay, well, size distribution isn't a natural phenomenon.

[00:28:45] Speaker 01:
That actually doesn't say anything.

[00:28:47] Speaker 01:
That's nonsense words.

[00:28:49] Speaker 01:
What is the natural phenomenon?

[00:28:51] Speaker 01:
The natural phenomenon is that this is bigger than this.

[00:28:54] Speaker 02:
What is the natural phenomenon?

[00:28:56] Speaker 01:
The size distribution tells me nothing.

[00:28:59] Speaker 02:
Then table one of the patent.

[00:29:02] Speaker 01:
I need you to tell me in words what the natural phenomenon is.

[00:29:05] Speaker 01:
That below 300 base pairs.

[00:29:08] Speaker 01:
Because despite American Exile, I still believe it's important that you can actually identify what it is you think the natural phenomenon is.

[00:29:15] Speaker 02:
Then I'm referring to table one, that at the size of DNA that is below 300 base pairs, approximately 70% of the DNA is fetal and approximately 30% is fetal.

[00:29:27] Speaker 02:
That between 300 and 500, it's roughly 20% and 80%.

[00:29:33] Speaker 02:
And that over 500 base pairs, it is overwhelmingly maternal.

[00:29:36] Speaker 02:
That is the natural phenomena.

[00:29:38] Speaker 03:
And what is the usefulness of that separation, determining at what point approximately you have something that is more useful and more indicative?

[00:29:50] Speaker 02:
There is nothing in the patent specification about that.

[00:29:54] Speaker 02:
All that is in the patent specification is that size distribution and the assertion that depending on what you want to do, you might want to pick a sample that is more or less enriched for fetal DNA.

[00:30:06] Speaker 04:
And that's because at the end of the day, that type of sample facilitates the diagnosis or the additional steps.

[00:30:13] Speaker 04:
Isn't it kind of like, I want to put a brand on some ponies.

[00:30:18] Speaker 04:
I have a corral that's full of horses.

[00:30:21] Speaker 04:
And so now my job is to eliminate or take out, because it's going to facilitate the branding of the ponies, my job is to take out the big horses.

[00:30:30] Speaker 04:
And the only thing that's left in the corral are the little ponies.

[00:30:33] Speaker 04:
and that facilitates my branding.

[00:30:36] Speaker 04:
I didn't invent the size of the horses and I didn't invent the brand.

[00:30:42] Speaker 04:
I just simply am separating them in order to facilitate the process.

[00:30:47] Speaker 02:
That is exactly right.

[00:30:48] Speaker 01:
However, let me build on the horsey analogy.

[00:30:53] Speaker 01:
What if you did discover

[00:30:56] Speaker 01:
that a particular size of horse was a better racer or a particular size of horse was better for some purpose.

[00:31:04] Speaker 01:
So you chose

[00:31:06] Speaker 01:
what size to keep and what size to exclude because you found that that created a better tool.

[00:31:13] Speaker 01:
One of them hooks up much better to the cart you want to pull across your land than the other.

[00:31:17] Speaker 02:
Had Illumina done tests to determine that some particular ratio of maternal and fetal DNA was optimal in order to achieve some particular result?

[00:31:29] Speaker 02:
and claimed that that was somehow unexpected or that there was some particular usefulness associated with that that was not simply a function of the size distribution itself, but was a function of something additional that they appreciated.

[00:31:42] Speaker 01:
But this is summary judgment, and they introduced evidence that demonstrates that the numbers they chose didn't exclude all the big horsies.

[00:31:51] Speaker 01:
or segregate out all just the little worsties.

[00:31:54] Speaker 01:
You lost some of both in the process.

[00:31:57] Speaker 01:
And that the reason they chose those numbers is because it created a sample size that was actually well-suited for types of diagnostic testing that would need to occur and contained enough of what you were looking for.

[00:32:09] Speaker 01:
And that's all evidence.

[00:32:10] Speaker 01:
And this is summary judgment.

[00:32:12] Speaker 01:
How does the district court disregard all of that on summary judgment?

[00:32:16] Speaker 02:
The latter part of that, Your Honor, is incorrect.

[00:32:18] Speaker 02:
That is not in the record.

[00:32:19] Speaker 02:
What is in the record is the amount of maternal and fetal DNA in those samples, and that is it.

[00:32:26] Speaker 02:
Illumina did not put in any expert evidence or any evidence whatsoever that suggests that these particular ranges are optimized for any purpose whatsoever.

[00:32:35] Speaker 02:
The only assertion in the patent, the only evidence of this is in the patent, and the only assertion in the patent is the sentence at column five of the 931 immediately preceding table one.

[00:32:47] Speaker 02:
that says depending on the downstream application, the DNA size chosen for the enrichment of fetal DNA will be smaller than 300 or smaller than 500.

[00:32:56] Speaker 02:
That's it.

[00:32:57] Speaker 02:
There is nothing in here that suggests a judgment as to what is going to be optimal for a particular purpose.

[00:33:04] Speaker 02:
And again, 300 and 500 are numbers.

[00:33:07] Speaker 02:
that do not result from a woman's ingenuity, they result from the commercial ladders that they chose, commercially available, in order to engage in the test that led to this supposed discovery.

[00:33:21] Speaker 02:
a test that itself would, according to Illumina, infringe.

[00:33:24] Speaker 02:
And I think this is an important point.

[00:33:26] Speaker 02:
In arriving at this discovery about the size difference of DNA, Illumina did precisely the thing that they are now claiming is their invention.

[00:33:35] Speaker 02:
They extracted.

[00:33:36] Speaker 03:
Council, these horses have raced past the finish line.

[00:33:41] Speaker 03:
So I think we'll give Mr. Dynas four minutes of rebuttal time.

[00:33:48] Speaker 00:
Thank you, Your Honor.

[00:33:51] Speaker 00:
First of all, I'd like to just correct a misstatement by council that goes to an important point.

[00:33:56] Speaker 00:
In table one, the 73% and the 26% for below 300 base pairs.

[00:34:02] Speaker 03:
Mr. Woodard, four minutes.

[00:34:04] Speaker 00:
Thank you, Your Honor.

[00:34:06] Speaker 00:
Those are medians, not the average.

[00:34:10] Speaker 00:
The range in the different samples were from 22% in one person to 87%

[00:34:17] Speaker 00:
in another in terms of the percent of fetal when you make this cut.

[00:34:21] Speaker 00:
The reason that's important is there is no constant.

[00:34:23] Speaker 00:
This isn't Ohm's law, this isn't some law of nature that 300 is, you're gonna always have 80% less or 20% less.

[00:34:32] Speaker 01:
It's different in different people and it might be- So to the extent that she hinged her entire natural law claim on table one and her representation that that amounted to an average, there's no way we could possibly accept it because it's actually wrong as a matter of fact.

[00:34:45] Speaker 00:
That's true.

[00:34:48] Speaker 00:
uh... and and so the point there is that there is no constant there is no you're only you know a discovery that at three hundred you're going to get eighty percent this way twenty percent that way or that so it's like if there was a mixture of horses that were all different sizes you said you know what in general we we want to have a large herd because we need to carry a lot of stuff but these are stronger

[00:35:10] Speaker 00:
What we find is that at 600 pounds, or that's probably a bad number, I'm not an equestrian, but at 1,500 pounds, you keep enough strong ones, but you don't lower the herd so much that you have nothing left.

[00:35:25] Speaker 00:
That's human judgment.

[00:35:26] Speaker 00:
That's engineering, Your Honor.

[00:35:28] Speaker 00:
That is not a natural law that says, oh, this is the tipping point.

[00:35:33] Speaker 04:
I would think that engineering is a bit more what Judge Moore was suggesting.

[00:35:38] Speaker 04:
and that's to breed horses for a particular task and to invent a different horse, you know, one that can pull a bigger wagon or something like that.

[00:35:49] Speaker 04:
But that's not what's happening here.

[00:35:51] Speaker 04:
Here, you're just simply separating two different types of DNA so that you drain the water,

[00:35:59] Speaker 04:
And now you're left with the substance that you want to work with.

[00:36:02] Speaker 04:
That's it.

[00:36:03] Speaker 00:
No, it's not the substance you want to work with.

[00:36:04] Speaker 00:
There's maternal DNA.

[00:36:06] Speaker 00:
You want to work with the fetal DNA.

[00:36:08] Speaker 00:
It's not that.

[00:36:09] Speaker 00:
That's not what it is.

[00:36:10] Speaker 00:
You have a mixture still.

[00:36:12] Speaker 00:
You have to make a judgment how much you want that mixture and where it'll blend.

[00:36:16] Speaker 00:
But let me make this point, because I think this is the capstone.

[00:36:20] Speaker 04:
But you didn't invent that mixture.

[00:36:22] Speaker 00:
Just like in cells direct.

[00:36:24] Speaker 04:
No one has invented this mixture.

[00:36:27] Speaker 04:
That mixture already exists.

[00:36:29] Speaker 04:
All you're doing is separating by size.

[00:36:31] Speaker 04:
Correct?

[00:36:33] Speaker 00:
We're making a judgment as to what the right hinge point is for these processes that are laboratory processes that you're using.

[00:36:43] Speaker 00:
But let me say this.

[00:36:44] Speaker 00:
Cells direct, your honor, is nearly on point.

[00:36:48] Speaker 00:
It's nearly directly on point.

[00:36:49] Speaker 00:
That's liver cells.

[00:36:51] Speaker 00:
that you want the ones that can survive freezing.

[00:36:54] Speaker 00:
So you freeze them, which is a trivial step.

[00:36:56] Speaker 00:
Everyone knows you could cryofreeze.

[00:36:58] Speaker 00:
You freeze them and you freeze them again.

[00:37:00] Speaker 00:
And you know what?

[00:37:01] Speaker 00:
You end up with more liver cells from the human body that you want because all you're doing is separating out the liver cells that can survive cold versus the liver cells that can't survive cold.

[00:37:14] Speaker 00:
How is that any different?

[00:37:15] Speaker 00:
It's not.

[00:37:17] Speaker 00:
And we go through this in our briefing.

[00:37:18] Speaker 04:
How do you distinguish this case from Ariosa?

[00:37:21] Speaker 00:
In Ariosa, all you did was you said you're detecting something that's present.

[00:37:26] Speaker 00:
Okay?

[00:37:26] Speaker 00:
You're not making a new preparation.

[00:37:28] Speaker 00:
You're just, the gee whiz there is, there's cell-free DNA in the sample, you can detect it.

[00:37:36] Speaker 00:
This is saying,

[00:37:38] Speaker 00:
There's a principle that, in general, maternal DNA is larger than fetal.

[00:37:43] Speaker 00:
That's a discovery.

[00:37:45] Speaker 00:
And the way we're going to marshal that to a practical laboratory technique for a specific type of test is we're going to do testing and experiments, which some are shown in Table 1.

[00:37:57] Speaker 00:
And we're going to say, OK, if we do it at this number, we keep enough of the good stuff

[00:38:03] Speaker 00:
we don't get rid of too much of the good stuff.

[00:38:05] Speaker 00:
And that's a human judgment that's made based on laboratory analysis, and it's really no different than cells direct.

[00:38:12] Speaker 03:
Thank you, Counsel.

[00:38:13] Speaker 00:
Thank you, Your Honor.

[00:38:14] Speaker 03:
The case is submitted.