[00:00:00] Speaker 03:
In 1202, Genetic Technologies Limited versus Muriel LLC.

[00:00:06] Speaker 02:
I'm getting settled.

[00:00:33] Speaker 02:
Mr. Lee?

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

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

[00:00:37] Speaker 04:
Good morning.

[00:00:37] Speaker 04:
May it please the Court.

[00:00:40] Speaker 04:
There are three issues that I hope to address today.

[00:00:43] Speaker 04:
First is a finding that claim one, the exemplary claim in this case, is patent eligible would be irreconcilable with this Court's decisions in AMP 1 and AMP 2, which found that the claim 20 of the myriad patent in that case was patent eligible because it was premised on the use

[00:01:02] Speaker 04:
of a man-made material.

[00:01:05] Speaker 04:
It would also create an exception, I believe.

[00:01:07] Speaker 04:
The AMP is myriad?

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It's the Association for Molecular Pathology line of cases.

[00:01:16] Speaker 04:
And there is a first case, AMP 1, and then a second case, AMP 2, that ultimately went up as myriad, yes.

[00:01:23] Speaker 04:
Oh, OK.

[00:01:23] Speaker 04:
Yes.

[00:01:24] Speaker 04:
It's also going to create an exception to the Supreme Court's guidance in Chakrabarti and in the myriad decision.

[00:01:31] Speaker 04:
which both cases held that manmade compositions are patent eligible.

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And in this case, claim one is premised on the use of a chemically altered, amplified, non-coding DNA.

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Second, when the court treats all of the allegations of GTG's amended complaints in this case as true, as it must under rule 12b6, there's only

[00:01:58] Speaker 04:
one logical conclusion that it can come to, and that is that GTG has plausibly demonstrated that claim one claims an eligible subject matter.

[00:02:07] Speaker 04:
And then thirdly, even if the court goes ahead and applies the Mayo-Alas test fully to claim one at this stage, it passes that test.

[00:02:21] Speaker 04:
The claim is not directed to a patent.

[00:02:24] Speaker 04:
How do you distinguish areas?

[00:02:27] Speaker 04:
I thought you might ask me that.

[00:02:29] Speaker 04:
There's a couple of things that readily distinguish this claim from Ariosa.

[00:02:34] Speaker 04:
Firstly, this claim, this patent was filed eight years earlier.

[00:02:40] Speaker 04:
So whatever the science was that was involved in the Ariosa.

[00:02:43] Speaker 04:
What difference does that make?

[00:02:44] Speaker 04:
Well, because we're measuring whether the use of the techniques in claim one were routine and conventional at the time that the patent was filed.

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in the Ariosa case.

[00:02:57] Speaker 05:
So you're challenging the second step of Mayo and saying they weren't routine and conventional when the patent was filed?

[00:03:04] Speaker 04:
The Ariosa claim, claims one, I believe, 125 and 26, those exemplary claims essentially said, we found a new place where you can find cell-free fetal DNA.

[00:03:17] Speaker 04:
Just go get it.

[00:03:20] Speaker 04:
Claim one in this case.

[00:03:22] Speaker 04:
The discovery is that there's linkage disequilibrium that can exist between a non-coding region and a coding region allele.

[00:03:30] Speaker 04:
And this inventor, Dr. Simons, realized that there is something I can do with this information.

[00:03:36] Speaker 05:
I can actually... I don't understand what the timing has to do with this.

[00:03:40] Speaker 04:
With respect to the amplification step, there was an amplification step in Ariosa.

[00:03:46] Speaker 04:
The issue in the Ariosa claim would have been whether it was routine and conventional to apply the amplification techniques in that claim in 1997 versus in our claim, claim one, that application was filed in 1989.

[00:04:02] Speaker 03:
So are you saying that amplifying was well-known and not inventive in Ariosa?

[00:04:08] Speaker 03:
Correct, Your Honor.

[00:04:08] Speaker 03:
Was inventive in your case?

[00:04:12] Speaker 04:
That's exactly what I'm saying, Your Honor.

[00:04:16] Speaker 04:
What the specification says is that amplification generically is a known technique, but we're applying this in a new way.

[00:04:29] Speaker 06:
I guess it seems to me that the argument that struck me as at the core of your point has nothing to do with timing.

[00:04:36] Speaker 06:
It is rather that Sequinam said

[00:04:39] Speaker 06:
We now know something exists.

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Use conventional techniques.

[00:04:43] Speaker 06:
Find it.

[00:04:43] Speaker 06:
Yours doesn't say that.

[00:04:45] Speaker 06:
Yours says we want to find A, the exons, the actual genes.

[00:04:49] Speaker 06:
And our clever idea is we're going to look for B. That's not, at least according to anything I see in the spec or the complaint or the district court opinion, proven for motion to dismiss purposes to be utterly conventional.

[00:05:07] Speaker 06:
If you want to find B, the allele, the last words of the claim are, in order to find the allele, look for something not the allele.

[00:05:17] Speaker 06:
Why is that not an inventive concept, which has nothing to do with timing?

[00:05:22] Speaker 04:
It is an inventive concept.

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And there's a couple of different ways to look at the inventive concept.

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But the timing issues, we're measuring when something is routine and conventional at the time that the patent is filed.

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So what might have become routine and conventional by the time that the areas of claim was filed?

[00:05:37] Speaker 05:
is completely different than that.

[00:05:39] Speaker 05:
Are you arguing that it's step two of Mayo that amplification wasn't routine and conventional when this patent was filed?

[00:05:49] Speaker 04:
It was not, Your Honor.

[00:05:50] Speaker 04:
And let me go back to what was happening at that point in time.

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So the two, one of the patents that's cited in the 179 application and in the patent is the Kerry Mullis patent on PCR amplification.

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Those patents, there was two actually and one of them cited in the 179 patent.

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Those patents didn't even issue until 1987 and they weren't licensed until 1989 for the first time.

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And that's the same year that the parent application for the 179 patent was brought.

[00:06:21] Speaker 06:
Were the techniques being practiced during all of the time that the application was pending before it was issued and licensed?

[00:06:28] Speaker 04:
The abstract technique of DNA amplification was being practiced at the time and the patent recognizes that and says, we are using this technique in a new way.

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Those of skill in the art would know how to implement this this way, but it's a new way to do it that nobody's ever thought of.

[00:06:47] Speaker 04:
And that was a

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an implementation that would... The problem is, I'm not sure, at least with me, you're going to make any progress on saying that amplification as described here as prior art and background is something new.

[00:07:06] Speaker 06:
But if the question is, is there a difference of legal significance between sequinom and this, the only thing that I can see is even a possibility

[00:07:18] Speaker 06:
is that the sequinom claim says, now that we know something exists, use the technique everybody would use to find it.

[00:07:27] Speaker 06:
This doesn't say that.

[00:07:29] Speaker 06:
This says, now that we know there's a link between A and B, we don't care about A for its own sake.

[00:07:36] Speaker 06:
We care about B. Find A in order to find B. That was Dr. Simon's

[00:07:43] Speaker 04:
observation as to how he could use his discovery that there was something existing, you know, there was a link between A and B to use your nomenclature.

[00:07:52] Speaker 04:
There is an inventive concept on top of what you're talking about.

[00:07:56] Speaker 04:
Which is what?

[00:07:57] Speaker 04:
It is no one had ever before amplified one region of DNA, created an amplified material, so this is now a man-made material that is chemically different, and

[00:08:10] Speaker 04:
and analyze that material in order to find a different location of DNA, regardless of whether those two locations of DNA is non-coding and coding.

[00:08:23] Speaker 04:
So just the technique of looking one place in DNA and amplifying it.

[00:08:27] Speaker 06:
I looked in the spec and the complaint, and at least my eyes were not picking up anything to the contrary of what you just said, that is,

[00:08:38] Speaker 06:
And this is why I'm fastening onto what I guess are the last words of the claim in order to find the allele, look for something else.

[00:08:47] Speaker 06:
I can't find the basis for saying, oh, everybody knows that once you know there's a linkage between A and B in this area, you can and indeed should look for A in order to find B.

[00:09:06] Speaker 06:
Regardless of what A and B are, as I think you just said.

[00:09:09] Speaker 04:
Correct.

[00:09:09] Speaker 04:
And that observation that one could look in one location to find another location was Dr. Simon's observation that was enabled by his discovery that these things did exist together.

[00:09:20] Speaker 04:
Nobody knew that.

[00:09:21] Speaker 05:
Yeah, but that's step one.

[00:09:23] Speaker 04:
Well, it is the discovery.

[00:09:25] Speaker 04:
And you're talking about the directed to.

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And so the question is, is the claim directed to?

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the discovery, and our position is that it's not.

[00:09:34] Speaker 04:
It doesn't recite the discovery.

[00:09:35] Speaker 04:
It doesn't claim it.

[00:09:37] Speaker 04:
And then the other issue, though, as some of this panel recognized in the BRCA1 case, is this directed to an abstract idea of using one thing to find another, where you know the two things are linked together.

[00:09:50] Speaker 04:
And our response to that is, there's an event of concept on top of that.

[00:09:56] Speaker 04:
and that is that no one had ever amplified one region of DNA before and examined that amplified material to detect a different location of DNA.

[00:10:08] Speaker 04:
That by itself is an inventive concept.

[00:10:12] Speaker 04:
That is enough to pass through that coarse 101 filter to be subject to a 102 and a 103 analysis.

[00:10:25] Speaker 04:
But I want to go back to claim 20 of the myriad patents and to show you why this claim one is identical to the claim 20 in that case.

[00:10:34] Speaker 04:
So in claim 20 of the myriad patent and the AMP1 and AMP2 decisions, that claim had three parts.

[00:10:43] Speaker 04:
It was growing two host cells, one in the presence of a cancer therapeutic, and then determining the growth rates and then comparing those growth rates.

[00:10:53] Speaker 04:
The determining and comparing steps were just abstract.

[00:10:56] Speaker 04:
There was no citation of any particular technique to do, to make the comparison, the determination.

[00:11:05] Speaker 04:
The growing of the cells, growing of cells, two different cells, a control and then a variable, and then comparing those two things together, scientists have been doing that for a long, long time.

[00:11:15] Speaker 04:
Doing those three steps together with cells, that had been being done.

[00:11:20] Speaker 04:
The only difference was in this claim

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What was claimed was the presence of an altered host cell that had the BRCA1 gene put into the cell.

[00:11:34] Speaker 04:
So that cell, though, exactly mimicked a naturally occurring cell.

[00:11:40] Speaker 04:
It was growing.

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It was meant to mimic what was happening in the human body, because in that claim, you're testing a cancer therapeutic.

[00:11:47] Speaker 04:
So that cell needs to be working just like a human cell.

[00:11:53] Speaker 04:
the man-made cell is created, it's identical in all aspects to a human cell that has the BRCA1 gene in it.

[00:12:03] Speaker 04:
And the court in that case held just the presence of this man-made cell and the fact that these claim steps are premised on the use of that cell conferred patent eligibility to that claim.

[00:12:16] Speaker 04:
And here in claim one,

[00:12:18] Speaker 04:
We have the same situation.

[00:12:19] Speaker 04:
If you look carefully at the claim limitations, the first limitation says that you amplify a non-coding, a genomic non-coding DNA sequence.

[00:12:28] Speaker 04:
So what I mean by genomic is that it's naturally occurring DNA to create a amplified non-coding sequence.

[00:12:38] Speaker 04:
And the word that's used in the claim is sequence.

[00:12:40] Speaker 04:
So we've created a multiple man-made copies of a sequence of DNA.

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And those copies are chemically different than the naturally occurring DNA.

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And the reason why is because in naturally occurring DNA, the cytosine is methylated.

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So you'll see a nitrogen-hydrogen group and a methylation group.

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And then there's an oxygen group.

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And then this would be the center.

[00:13:07] Speaker 04:
If I charted this molecule for you, it would look kind of like this.

[00:13:13] Speaker 04:
When you amplify DNA,

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The same cytosine or methylcytosine becomes cytosine, and it looks like this.

[00:13:19] Speaker 04:
So this methylation or atom is gone.

[00:13:25] Speaker 06:
And every nucleotide?

[00:13:28] Speaker 04:
It is lost in any methylated cytosine when it's amplified.

[00:13:32] Speaker 04:
It looks like this.

[00:13:33] Speaker 04:
It goes from this to this.

[00:13:36] Speaker 04:
So it is, in fact, chemically different.

[00:13:39] Speaker 04:
This is a factual... That's part of the amplification stuff.

[00:13:43] Speaker 04:
It happens during the amplification step, and the change in the chemical status is alleged in detail.

[00:13:50] Speaker 04:
What kind of amplification step couldn't be patentable if it were novel?

[00:13:54] Speaker 04:
The problem is it isn't.

[00:13:57] Speaker 04:
Amplification in of itself is not novel, but what our claim one does is it requires the practitioner to create amplified DNA, which is a man-made material that is chemically different, which we allege in our complaint.

[00:14:10] Speaker 04:
is chemically different in great detail, the methylation status.

[00:14:14] Speaker 04:
And so this is something that the court has to deem as true on Rule 12b6 motion.

[00:14:19] Speaker 04:
And then in the second step of the claim, it says you have to analyze that amplified non-coding DNA sequence, that man-made material.

[00:14:29] Speaker 04:
And it's a section of material, OK?

[00:14:33] Speaker 04:
Then from that analysis step, you have to detect the coding region.

[00:14:38] Speaker 04:
So it's a whole process.

[00:14:40] Speaker 04:
It's not just like an area somewhere.

[00:14:42] Speaker 05:
What you're suggesting is that if at the second step there's something that could be patentable, if it were novel, is that that takes us out of MAYA.

[00:14:52] Speaker 05:
That's right.

[00:14:53] Speaker 05:
Well, that's a hard sell.

[00:14:55] Speaker 04:
Well, but it's not just the fact that we're amplifying the location.

[00:14:59] Speaker 04:
Because once you amplify it, you actually have to do something else to it in order to detect the allele.

[00:15:04] Speaker 04:
So you're not only creating a man-made material, which this court has held, if the claim is premised on the use of a man-made material that's not naturally existing, and which claim one is, that confers patent eligibility in of itself.

[00:15:19] Speaker 04:
And the AMP decision actually says, even if all the steps that you're performing on that ineligible material are routine and conventional, and as they were in the Claim 20 case.

[00:15:31] Speaker 04:
So under the AMP decisions,

[00:15:34] Speaker 04:
Claim one is patent-eligible.

[00:15:36] Speaker 04:
Following the Mayo-Alice protocol, applying that test, we think it's also patent-eligible because, firstly, we don't think it's directed to either the discovery, Dr. Simon's discovery of the linkage disequilibrium, or his observation of how one could generally use that.

[00:15:55] Speaker 04:
And there are other ways that one can use his observation, using the non-coding to find the coding that are alleged in our complaint.

[00:16:03] Speaker 04:
and not contested by the other side.

[00:16:06] Speaker 04:
And then there's this inventive concept on top of that, which is that no one had ever amplified one location of DNA before, taken that, analyzed it to find something else.

[00:16:18] Speaker 03:
We are into your rebuttal, so you can sign it.

[00:16:22] Speaker 03:
We'll restore three minutes.

[00:16:25] Speaker 02:
Thank you.

[00:16:40] Speaker 00:
Good morning, Your Honor, and may it please the Court.

[00:16:43] Speaker 00:
In our view, Judge Dyck-Ariosa does control this case.

[00:16:47] Speaker 00:
The distinctions that have been offered here are distinctions that were already dealt with and rejected in the Ariosa case, and I think I can go through those in relatively short order.

[00:16:55] Speaker 06:
Can you focus on the one that I guess I'm fastening onto, which I guess is to use

[00:17:01] Speaker 06:
the expression just given, nobody had ever amplified region A to find region B before.

[00:17:05] Speaker 06:
That's certainly not the case in Sequenon, so on the facts it would be different.

[00:17:09] Speaker 06:
Well, unless you misunderstood it, and second, how do we know on this record on a motion to dismiss that that adds nothing to the scientific regularity of nature that region A and region B travel together in generations?

[00:17:25] Speaker 00:
Sure, well, so to start with the first part of your question,

[00:17:29] Speaker 00:
In the sequin on decision there was a discovery it was a new discovery No one knew about it before the fact that there was cell free fetal DNA floating in the mother's blood and plasma That's and the claims said find it and the and the claims said this thing is here go find it and That's no it's really no different than what we've got here exactly this does this is different because the last words of the claims say

[00:17:59] Speaker 06:
Find a in order to find b right but that find a in order to find b is the natural correlation That is the same natural that is the same natural phenomenon that is not finding something is not Is not is only one thing you can do with the fact that a and b are correlated Maybe maybe nobody would think if I want to find the order

[00:18:24] Speaker 06:
Maybe everybody would think, if I want to find B, look for B. Why would I bother to look for A?

[00:18:29] Speaker 06:
Because somebody had an idea that says A might be easier to find.

[00:18:33] Speaker 00:
OK, so I think what's happening here is that my friend on the other side has tried to divorce, rather artificially, the discovery and the observation.

[00:18:46] Speaker 00:
And what you're suggesting to me is that the observation is what?

[00:18:49] Speaker 06:
Put aside his terminology.

[00:18:52] Speaker 06:
I'm just, look, I mean, we are in, to put it mildly, uncharted and unclear territory here.

[00:18:58] Speaker 06:
And I'm trying to figure out where this goes.

[00:19:03] Speaker 06:
At some point, as the Supreme Court recognized, every single thing in biology is about identifying what's going on in the natural world, in human bodies.

[00:19:12] Speaker 06:
At some point, there are techniques for making use of that that must be on the patent-eligible side of the line.

[00:19:20] Speaker 06:
Why is it not on the patent eligible side of the line to say, now that I know that A and B occur together with a regularity, that if I'm interested in B, I'll think about finding A. That doesn't seem like the same thing as the fact that there is this regularity.

[00:19:41] Speaker 00:
Well, if it isn't the same thing, it's awfully close to the same thing.

[00:19:44] Speaker 00:
And how do you get to the same thing?

[00:19:46] Speaker 00:
You get to the same thing through the exact same

[00:19:49] Speaker 00:
routine and conventional steps that were set forth not only in this patent specification itself.

[00:19:54] Speaker 06:
But once you decide that it's a good idea to look for A to find B, it may be that the steps are routine and conventional.

[00:20:02] Speaker 06:
But so what?

[00:20:03] Speaker 06:
Why is that enough?

[00:20:06] Speaker 00:
Why is that enough?

[00:20:06] Speaker 00:
Because what you're doing, it's exactly Mayo and it's exactly Arioso.

[00:20:10] Speaker 00:
You are starting with a natural law, a natural phenomenon.

[00:20:14] Speaker 06:
Sequinon is written not in terms of natural laws, but natural phenomena, namely the thing itself, the self-free fetal DNA.

[00:20:22] Speaker 00:
Right.

[00:20:23] Speaker 00:
And this is no different than that.

[00:20:24] Speaker 00:
This is the thing itself.

[00:20:26] Speaker 00:
This is that there is a correlation between this non-coding region and this coding region.

[00:20:30] Speaker 06:
Well, it seems to me we've moved from natural phenomenon to law of nature.

[00:20:34] Speaker 00:
I think the terminologies have been used interchangeably, but the phenomenon

[00:20:39] Speaker 00:
uh... is probably a way to look to suggest that we're talking about the observation versus the discovery of the natural law in that case we have the admission of the other side that even that observation is an abstract idea and so what we what we've got here is is either at the start of the claim a natural law or natural phenomenon followed by an abstract idea combined with routine conventional steps i would actually say to you your honor that this case is even farther away from that

[00:21:08] Speaker 00:
that mythical line of patent eligibility that Ariosa is.

[00:21:13] Speaker 00:
Ariosa, at least you had this very specific application that this is going to be a great opportunity to not have to put a big needle into the fetus or into the placenta in order to get the sample to detect any abnormalities in the fetus of a pregnant woman.

[00:21:33] Speaker 00:
you have just a very generic claim.

[00:21:35] Speaker 00:
It's a generic instruction to analyze some DNA in some way and using techniques which are conventional and routine and set forth as such in the patent, in the complaint, and in the prosecution history, which is part of the 12b6 record here.

[00:21:50] Speaker 00:
Now that takes me to the other question that you've asked me, which is why is this record appropriate for disposition on 12b6 instead of, say, summary judgment?

[00:22:01] Speaker 00:
Ariosa, in part, can answer that, because yes, that was a summary judgment decision.

[00:22:05] Speaker 00:
But look at what was relied on.

[00:22:06] Speaker 00:
Look what was necessary to the decision.

[00:22:09] Speaker 00:
There is only one reference to some deposition testimony in there.

[00:22:12] Speaker 00:
Everything else is claims and specification.

[00:22:15] Speaker 00:
Claims and specification, and also one reference there to prosecution history.

[00:22:20] Speaker 00:
Your decisions from this court in Ultramershal on remand, the 772F3rd version of it, the content extraction decision,

[00:22:30] Speaker 00:
the OIP Technologies case, and in judgment on the pleadings, BySafe versus Google, which I think there's a lot of overlap between the members of this panel, but those are all presidential decisions of this court.

[00:22:41] Speaker 00:
And they all recognize that this 101 issue is appropriate for Rule 12b6 determination.

[00:22:46] Speaker 06:
Sure.

[00:22:47] Speaker 06:
And there can't be any doubt that sometimes it's appropriate.

[00:22:50] Speaker 06:
It depends on whether the knowledge necessary to decide if anything beyond

[00:22:57] Speaker 06:
the underlying ineligible matter, whether it's abstract idea or regularity of nature, is, I guess, in Mayo's language, but not Alice's language, routine, conventional, and whatnot.

[00:23:11] Speaker 06:
As to this case, I guess I'm struggling to understand.

[00:23:16] Speaker 06:
It seems to me if I say everybody would know that once you notice there's a correlation

[00:23:24] Speaker 06:
between A and B, if you want to find B, look for A, I would be saying to myself, I'm just making that up.

[00:23:29] Speaker 06:
Maybe it's true, maybe it's not true.

[00:23:31] Speaker 06:
I mean, I'm not Dr. Toronto with a PhD in biology.

[00:23:36] Speaker 06:
How do I know this?

[00:23:37] Speaker 00:
Well, Judge Toronto, I think that the answer is that if there's a correlation, if when you see A, B appears,

[00:23:45] Speaker 00:
then it is, in the words of Mayo, well understood and routine and obvious.

[00:23:53] Speaker 06:
How do I know that?

[00:23:55] Speaker 06:
I know it in Mayo because, in fact, the physical steps at issue were, in fact, undisputedly all being done.

[00:24:03] Speaker 06:
The particular drug was being given to patients, and blood was being drawn to get the metabolites.

[00:24:11] Speaker 06:
And the only thing that was new was, look at the number.

[00:24:15] Speaker 06:
That's all.

[00:24:16] Speaker 06:
But here we have new physical steps.

[00:24:20] Speaker 06:
When you're looking for B, look for A. I'm truly at a loss to understand how I am, without being presumptuous, to say everybody knows that that would be a really good idea.

[00:24:38] Speaker 00:
Well, I'm having a hard time with all respect, Your Honor, and I don't want to be presumptuous as the advocate standing in front of the judges.

[00:24:44] Speaker 00:
I'm having a hard time understanding how that isn't just another way of phrasing the natural law or, putting in my friend's terms, the abstract idea.

[00:24:54] Speaker 00:
That is the relationship between A and B, as we've been discussing here.

[00:24:57] Speaker 06:
Suppose, for example, that the allele differences, the number of nucleotide differences between alleles was not a single one, but say was 17,000, and the number of

[00:25:13] Speaker 06:
nucleotide differences in the associated introns was two.

[00:25:20] Speaker 06:
You probably wouldn't go look for the intron difference because they'd be a lot harder to find.

[00:25:27] Speaker 06:
Now, how do I know that it's a good idea to look for the intron difference in order to find the exon difference when you could just look for the exon difference?

[00:25:36] Speaker 00:
I think you've just assumed away the natural law that we all know doesn't count.

[00:25:40] Speaker 06:
No, but the natural law that's described is that there are certain associated introns and exons.

[00:25:46] Speaker 06:
Right?

[00:25:46] Speaker 06:
That's right.

[00:25:48] Speaker 06:
Why would you look for the introns if you're ultimately interested only in finding the exons?

[00:25:55] Speaker 00:
Because now that you have the natural law in front of you, which is part of the general understanding, part of what belongs to everybody, now you know that when you have A, you're going to have B. And ultimately, I want to make sure that in my time here, I am addressing not only your questions, but the arguments made by my friend.

[00:26:15] Speaker 00:
Ariosa, back to Ariosa for a second.

[00:26:19] Speaker 00:
If you look at section 5, the beginning of section 5 of the opinion, the part that begins for completeness,

[00:26:24] Speaker 00:
The same argument that's being made here, which is that no one was using the plasma or serum of pregnant mothers to amplify and detect paternally inherited CFF DNA, was made and rejected by the panel in that case.

[00:26:37] Speaker 00:
That's after the denial of rehearing.

[00:26:40] Speaker 00:
That's the law of the circuit.

[00:26:43] Speaker 00:
Judge Dyke's proposed approach in Ariosa, I think, also makes this case fit comfortably within

[00:26:49] Speaker 00:
the cases that are patented ineligible.

[00:26:51] Speaker 00:
This is not a narrow in scope application.

[00:26:53] Speaker 00:
It is a very broad in scope application.

[00:26:56] Speaker 00:
When you contrast that to the myriad claims that my friend brought up, I think he said claim 20, you had a transformation into an entirely different material, which was starting at the beginning of that case.

[00:27:09] Speaker 00:
You were growing two host cells.

[00:27:11] Speaker 00:
This case, you're simply amplifying.

[00:27:14] Speaker 00:
And if there's any dispute about what amplifying means,

[00:27:17] Speaker 00:
the answer could be found in the fairly large definition sections of this patent.

[00:27:22] Speaker 00:
And it says at column 5, line 55, the term amplified DNA sequence refers to DNA sequences which are copies of a portion of a DNA sequence in its complementary sequence, which copies correspond in nucleotide sequence to the original DNA sequence in its complementary sequence.

[00:27:39] Speaker 00:
Under BRCA1 and the Dolly the Sheep Roslyn Institute case, copies aren't enough in the same way that having

[00:27:47] Speaker 00:
Different bonds at the end of the isolated DNA weren't enough to make the composition claims to naturally occurring DNA in the Myriad case eligible for a patent according to the Supreme Court.

[00:27:58] Speaker 00:
So with that, unless the Court has further questions for me, I'll cede the remainder of my time to Ms.

[00:28:04] Speaker 00:
Wigmore.

[00:28:05] Speaker 00:
Thank you.

[00:28:12] Speaker 01:
Good morning and may it please the Court.

[00:28:14] Speaker 01:
I would just like to briefly address Judge Toronto's question about the Ariosa case.

[00:28:19] Speaker 01:
In fact, the claim in that case is nearly identical to the claim here in the sense that the idea was to detect DNA of fetal origin by looking at the paternal DNA and the maternal sample.

[00:28:32] Speaker 01:
So there was this natural law that those were correlated

[00:28:36] Speaker 01:
And again, you're looking at a sample of paternal DNA in the maternal blood to detect something about the fetal.

[00:28:43] Speaker 06:
So clarify this for me.

[00:28:46] Speaker 06:
And this will confirm my comparative ignorance of the biology.

[00:28:52] Speaker 06:
Is the paternal DNA part of the fetal DNA?

[00:28:56] Speaker 01:
It is DNA of paternal origin that's found in the maternal sample.

[00:28:59] Speaker 01:
That's found in the fetal DNA.

[00:29:01] Speaker 01:
And it indicates something about the fetal DNA.

[00:29:03] Speaker 06:
It's a part of the fetal DNA.

[00:29:05] Speaker 01:
The paternal DNA?

[00:29:07] Speaker 06:
Yes.

[00:29:08] Speaker 06:
Is it?

[00:29:08] Speaker 01:
It's referred to in the claim as... It's just various sequences.

[00:29:13] Speaker 06:
I mean, you've got the fetal DNA.

[00:29:16] Speaker 06:
Some parts of it are coming from the mother and sometimes some from the father, and you're looking for the father ones because the mother's ones are not going to distinguish between the maternal

[00:29:24] Speaker 06:
DNA in the fetal.

[00:29:25] Speaker 06:
That the paternal is, in fact, the fetal DNA.

[00:29:28] Speaker 01:
Yes.

[00:29:28] Speaker 01:
And the discovery was that if you identify that paternal DNA in the blood, that will tell you something about the fetus.

[00:29:35] Speaker 01:
So that is analogous to the claim in this case, where you have a known natural law that correlates the non-coding DNA with the coding DNA.

[00:29:46] Speaker 01:
And what the claim does is basically say, amplify to determine the non-coding DNA and analyze that to determine

[00:29:54] Speaker 01:
if there's a correlation.

[00:29:55] Speaker 01:
There's nothing specific in the claims about a particular application.

[00:29:59] Speaker 01:
It simply says, as in Mayo, amplify using routine conventional steps, analyze using routine and conventional steps, and use that information as you see fit based on this natural law of the correlation.

[00:30:13] Speaker 01:
So it's simply applying a natural law using routine and conventional steps.

[00:30:20] Speaker 01:
Thank you.

[00:30:25] Speaker 04:
A couple of things I'd like to address firstly.

[00:30:28] Speaker 04:
The claim one is not simply when you find A, you've found B. If you look at the claim limitations, it requires that you create an amplified DNA sequence.

[00:30:38] Speaker 04:
And then you have to analyze that.

[00:30:40] Speaker 04:
And you may not find A. And therefore, you don't find B. So you don't automatically in this claim, as the other side suggests, is once you amplify the region of interest, you've essentially, the whole thing collapses into you've found B.

[00:30:54] Speaker 04:
there's an additional step that's required, and that's the analysis step.

[00:30:57] Speaker 05:
And then when that step is performed, you detect B. Is it fair to say that these claims cover any comparison for any purpose?

[00:31:10] Speaker 04:
You can use the technique wherever there is, in fact, linkage disequilibrium that exists between a non-coding region and a coding region.

[00:31:19] Speaker 04:
As long as you can, as long as you know that that exists, then the technique would work.

[00:31:25] Speaker 04:
Pretty broad.

[00:31:26] Speaker 04:
It's widely applicable.

[00:31:27] Speaker 04:
I wouldn't say it's broad.

[00:31:29] Speaker 04:
It's just like DNA amplification.

[00:31:30] Speaker 04:
It works on all DNA, not just one little area of DNA.

[00:31:34] Speaker 04:
It's a process that works everywhere, but where there is this linkage to C-polybrane.

[00:31:41] Speaker 04:
Other point I want to highlight, there is no evidence in this case that the way that Dr. Simon's applied amplification and the other parts of the claim

[00:31:49] Speaker 04:
was routine and conventional at the time that this patent was filed.

[00:31:52] Speaker 04:
The examiner's reasons for allowance, which we cite on page five of our opening brief, specifically said that the Mullis reference, so this is the groundbreaking patent on PCR amplification, does not teach or suggest applying this technique to the non-coding DNA.

[00:32:12] Speaker 04:
The Delayla reference that the other side had.

[00:32:15] Speaker 06:
But that all by itself can't distinguish sequinon.

[00:32:20] Speaker 06:
is about the application of old techniques to a particular molecule that it had never been applied to.

[00:32:26] Speaker 06:
And the court said, nevertheless, that's ineligible under 101, because all the techniques are old.

[00:32:34] Speaker 06:
In Ariosa... Including in combination.

[00:32:37] Speaker 04:
They found a new source for a material that was known.

[00:32:40] Speaker 04:
If you just take the CFDNA out of that claim, which I don't think is a proper analysis, by the way, but if you take that CFDNA out of the claim and you just say,

[00:32:48] Speaker 04:
We found a new source of biological material.

[00:32:51] Speaker 04:
At the time that that claim was filed, it was very well known to use amplification to just go get a DNA sample from a biological source, just the way that it was claimed.

[00:33:04] Speaker 04:
So they just said, go get it.

[00:33:06] Speaker 04:
Don't do anything with it.

[00:33:07] Speaker 04:
They said, go get this material, which we already know about, which we already are using, and go get it.

[00:33:14] Speaker 04:
That's it.

[00:33:14] Speaker 04:
And then some of the dependent claims had performed a test on it, which was also very well known.

[00:33:20] Speaker 04:
Tested to see if it has a particular trait.

[00:33:24] Speaker 04:
And it was just getting the material from a different source that was new.

[00:33:28] Speaker 04:
And that was the discovery.

[00:33:30] Speaker 04:
The last thing I want to talk about is just Dr. Simons.

[00:33:32] Speaker 04:
Put ourselves back in the shoes of Dr. Simons, back when he made his discovery.

[00:33:36] Speaker 04:
Everybody thinks that non-coding DNA is junk.

[00:33:39] Speaker 04:
They literally called it junk.

[00:33:42] Speaker 04:
He realizes that there is a

[00:33:45] Speaker 04:
a correlation between the two that can exist.

[00:33:50] Speaker 04:
One can be in linkage disequilibrium with the other location, but not in the coding region.

[00:33:56] Speaker 04:
And he then thinks, well, what can I do with this now that I know this?

[00:34:01] Speaker 04:
What are some of the other possible things that one might do with the fact that there's this correlation?

[00:34:06] Speaker 04:
Well, you could use B to find A is the first thing.

[00:34:09] Speaker 04:
And we're only claiming using A to find B. What else?

[00:34:15] Speaker 04:
Honestly, I don't know.

[00:34:16] Speaker 04:
I'm not a scientist like yourself.

[00:34:19] Speaker 04:
I'm not a scientist either.

[00:34:21] Speaker 04:
But at least we're only using one A to find B, not B to find A, to the extent that using B to find A might be useful.

[00:34:29] Speaker 04:
That is not precluded at all by the patent.

[00:34:33] Speaker 04:
So Dr. Simons makes his observation.

[00:34:36] Speaker 04:
I can use A to find B. How am I going to practically implement this?

[00:34:42] Speaker 04:
What tools are available to me to do this?

[00:34:46] Speaker 04:
I've just heard about amplification.

[00:34:48] Speaker 04:
This patent's just issued in 1987.

[00:34:50] Speaker 04:
They're not even under license yet.

[00:34:54] Speaker 04:
Maybe I can use that tool as a part of my process.

[00:34:58] Speaker 02:
I will create.

[00:34:59] Speaker 02:
I don't want to cut you off, but you've extended your time if you have one final thought, quick thought.

[00:35:05] Speaker 02:
I'm sorry?

[00:35:05] Speaker 02:
You exceeded your time if you have one final thought.

[00:35:09] Speaker 04:
I've finished.

[00:35:09] Speaker 04:
Thank you.

[00:35:10] Speaker 02:
Thank you.

[00:35:10] Speaker 02:
Goodbye.

[00:35:11] Speaker 02:
We thank all parties, and the case is submitted.