[00:00:00] Speaker 03:
Good morning, everyone.

[00:00:02] Speaker 03:
The first argued case this morning is number 172508, Athena Diagnostics Incorporated against Mayo Collaborative Services.

[00:00:13] Speaker 03:
Mr. Gov.

[00:00:14] Speaker 00:
Good morning.

[00:00:15] Speaker 00:
I'm Adam Gatton.

[00:00:16] Speaker 00:
I'm here this morning on behalf of Athena and Oxford and the Max Planck Institute.

[00:00:23] Speaker 00:
The district court got the Mayo-Alice 101 analysis

[00:00:28] Speaker 00:
wrong at step one and step two for the same fundamental reason.

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And that is that the court oversimplified the claims and massively oversimplified the specification.

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And then procedurally, the court sort of set Athena up to respond to a motion for summary judgment and to provide evidence and then refuse to allow it to

[00:00:56] Speaker 00:
And people rely on that evidence, again, taking a view of the specification and the claims.

[00:01:02] Speaker 00:
That was as if viewing it through a straw.

[00:01:04] Speaker 00:
Now, at step one, this oversimplification.

[00:01:06] Speaker 02:
Counsel, these claims are awfully simple.

[00:01:10] Speaker 02:
It doesn't seem to be a lot to them.

[00:01:12] Speaker 02:
And it's not clear to me how they differ from the other natal case.

[00:01:18] Speaker 02:
You're taking musk and you're combining it with a bodily fluid.

[00:01:26] Speaker 02:
There doesn't seem to be a lot to that.

[00:01:32] Speaker 02:
And then you get an antibody, a musc antibody complex, which surely is due to natural law.

[00:01:44] Speaker 02:
And then when immunoprecipitates,

[00:01:50] Speaker 02:
with a label wherein appear mental, it indicates whether the person is suffering from one of these muscular diseases.

[00:02:06] Speaker 02:
And that is seemingly a natural relationship, too.

[00:02:11] Speaker 02:
So how do we get around a basic law given to us by the Supreme Court in the earlier Mayo case?

[00:02:19] Speaker 00:
What you just described, after all, is a process that requires a person to do certain things, right?

[00:02:26] Speaker 00:
And so when you have a method as a process, and processes are categorically eligible under Section 101, they are only ineligible when the process or the method sort of wholly embodies nothing but a natural law, and dear... Inordinary physical processes.

[00:02:44] Speaker 02:
That's what the earlier

[00:02:47] Speaker 00:
But here we certainly don't have an ordinary physical process, right?

[00:02:52] Speaker 00:
The first step, right, contacting a bodily fluid with a labeled mosque or epitope or androgenic determinant, those are absolutely novel, non-natural, synthetic, labeled fragments of proteins that never anywhere exist naturally in bodily serum or plasma or whatever the sample might be.

[00:03:16] Speaker 00:
The specification goes into great detail about how the inventors found the binding sites on this very complex, enormous transmembrane protein, and how they developed the fragments that would allow the binding portion, the epitope or antigenic determinant, to be in bodily fluid, to be detectable, and still permit for specific binding of the antibodies.

[00:03:44] Speaker 02:
I didn't see that in the claims.

[00:03:46] Speaker 00:
Well, the claims require the use of those man-made fragments and epitopes, antigenic determinants, in the first step of the process.

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You can't do this process without labeled musk or one of these absolutely novel and non-natural fragments.

[00:04:08] Speaker 04:
How do you respond to the point made by the district court

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your adversary about how your specification suggests that the technique for labeling the musk and other steps in the claim are just conventional steps?

[00:04:26] Speaker 00:
Well, I think you have to look specifically at what the specification says.

[00:04:30] Speaker 00:
And my response is, as I said at the beginning, that's very much looking at the claims and the specification through a straw, right?

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The statement to which you're referring and on which the district court overly relied

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is that immunoprecipitation and iodination are standard techniques in the art.

[00:04:50] Speaker 00:
Now, it might be the case that immunoprecipitation, that is how one gets some antibody antigen complex out of the solution, out of serum, that might have been known.

[00:05:02] Speaker 00:
But the claims, right, immunoprecipitation is just one part of it.

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To get immunoprecipitation to work in this assay, right, which is a novel assay and the first assay of any kind,

[00:05:14] Speaker 00:
for detecting musk autoantibodies, you must have these non-natural synthesized fragments labeled with histidines possibly, or epitope tags as the specification describes, and then further labeled with radioactive iodine.

[00:05:34] Speaker 04:
Is that all special for musk?

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I mean, is that the things you're referring to?

[00:05:39] Speaker 04:
Or is that something that would only

[00:05:42] Speaker 04:
apply because we're talking about musk, or would that apply to any protein?

[00:05:47] Speaker 00:
Well, I think one thing that the DiTomaso declaration covers in great depth, and there's certainly nothing in the record to suggest otherwise, even without the declaration, is that these transmembrane proteins, right, or proteins in general, are massive, complex molecules.

[00:06:06] Speaker 00:
They're not like DNA that always works the same way, that just has the four base pairs and the same backbone and all the rest of it.

[00:06:12] Speaker 00:
So how you determine where an antibody binds a protein, and that's sort of shown in Figure 1 in the patent and described later on, is different for every protein, right?

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You've got to find a specific binding site.

[00:06:25] Speaker 00:
And then in order to make a protein like musk, which is a muscular

[00:06:31] Speaker 00:
and doesn't exist in serum or in the blood.

[00:06:34] Speaker 00:
In order to get it to work in an assay like this, you've got to sort of chop it up and make sure that you've got the right epitope, that is, the portion of it to which the antibody specifically binds, so that it can be detected and so that you don't interfere with the specific binding, and that will be different for every protein.

[00:06:54] Speaker 04:
I see how that's discussed in detail in your declaration, the expert's declaration.

[00:07:00] Speaker 04:
Where can I find that in the specification?

[00:07:03] Speaker 00:
Sure.

[00:07:03] Speaker 00:
So, figure one of the specification, and find that appendix 37 for now.

[00:07:15] Speaker 00:
Figure 1A sort of represents the work the inventors did to figure out which portion of the

[00:07:23] Speaker 00:
of the transmembrane proteins, so the part below the horizontal line there is within the cell, and then the IgG regions, which are extracellular, they're outside the cell, and they discovered, as discussed later in the specification, I'll certainly find it, that the antibody of interest, the autoantibody to musk, bound specifically at the IgG1 to 2 region.

[00:07:50] Speaker 00:
Without that discovery, and then without

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the work that the inventors put in to find and make the fragments, which is also discussed in the specifications.

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I'm happy to direct you to the relevant portions.

[00:08:03] Speaker 00:
You couldn't do this in all those assets.

[00:08:05] Speaker 02:
You're really talking about enablement, aren't you?

[00:08:08] Speaker 02:
All these steps to find the right location, those aren't in the claims.

[00:08:14] Speaker 00:
Well, the claims require the use of these fragments in the method.

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So a person of ordinary skill in the art

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would understand and would know to go to the spec to see what had to go into making this method possible.

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So I think it is an eligibility.

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It might also be an enablement question when we get there.

[00:08:33] Speaker 00:
But I think it's an eligibility question because the issue, right, is, is this an off-the-shelf, anyone knows how to do an assay such as you had?

[00:08:42] Speaker 00:
is certainly all the earlier DNA cases, and in many other... How does this immunoprecipitation work?

[00:08:48] Speaker 02:
Does it result from the formation of the complex that just drops out, or does one have to add some precipitating agent?

[00:08:58] Speaker 00:
In this method, there's a second antibody that's added to cause the first complex to precipitate out.

[00:09:03] Speaker 00:
But what makes these claims eligible

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in contrast to all the DNA cases and to the Mayo case with biopurine and the Cleveland Clinic case with MPO is that this assay, right, did not exist before.

[00:09:18] Speaker 00:
There was no, there was no Musk assay whatsoever of any kind before this one.

[00:09:25] Speaker 02:
But this isn't a novelty question.

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And discovering something new is not necessarily the answer to the abstract, to the natural processes exclusion.

[00:09:38] Speaker 00:
Well, I didn't mean it to come across as a novelty question.

[00:09:42] Speaker 00:
I was comparing it to those earlier cases because in all of those earlier cases, the courts make the point that with respect to DNA, all these techniques for DNA amplification and so forth were known off-the-shelf techniques.

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In the Mayo case itself, doctors have forever been testing for these thiopurin metabolites for the very reason described

[00:10:02] Speaker 00:
in those claims, and so that was also off the shelf.

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And the same thing was true in the Cleveland Clinic case with respect to testing for the presence of MPO.

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And that was a decision point in those cases.

[00:10:14] Speaker 00:
That's why they were not eligible methods.

[00:10:18] Speaker 00:
In this case, the inventors discovered a correlation, it's true, between myasthenia gravis and the presence of these musk oil antibodies, but it went the next step, as in cells direct

[00:10:29] Speaker 00:
for example, and deer, and came up with a new assay in order to make use of this discovery.

[00:10:37] Speaker 00:
Without the inventors having done the epitope mapping and done the fragmentation, you couldn't have this method.

[00:10:46] Speaker 00:
And it is in the claims, I submit, because the claims require the use of labeled musk or an epitope or an antigenic determinant.

[00:10:56] Speaker 00:
Those terms are

[00:10:59] Speaker 00:
in the claim, and they describe a crucial, essential, that without which not part of this assay, which didn't exist before.

[00:11:09] Speaker 00:
You couldn't just, you know, as in the older cases, you know, pull a machine off the shelf and dial it to musk and have the antibodies precipitate out.

[00:11:18] Speaker 04:
I know what you're saying, but what about the fact that you preamble as directed to a method for diagnosing neurotransmission or developmental disorders?

[00:11:26] Speaker 04:
It's not directed to a new assay.

[00:11:30] Speaker 04:
which is Musk.

[00:11:31] Speaker 00:
Well, but the assay is, I mean, it's a method of diagnosing by doing these things.

[00:11:35] Speaker 00:
I mean, you must do these specific things, right?

[00:11:38] Speaker 00:
And in contrast to the earlier cases, it's not, for example, a method of diagnosis by, you know, to use a language, some of the earlier cases, like Cleveland Clinic, for example, simply determining in whatever manner

[00:11:50] Speaker 00:
the determiner wishes to use or detecting in one of, you know, a litany of known and already in use steps.

[00:11:58] Speaker 00:
You've got to do it this way.

[00:12:00] Speaker 03:
But your broadest claims are not limited to how it's done.

[00:12:05] Speaker 00:
We're not asserting the broadest claims, and that's a good point, right?

[00:12:08] Speaker 00:
So we get down to claims seven, eight, and nine, for example.

[00:12:12] Speaker 00:
This is, these are the claims we're asserting, and you can only do

[00:12:17] Speaker 00:
those methods in that way.

[00:12:18] Speaker 00:
You've got to use these epitopes or these fragments and you've got to do immunoprecipitation.

[00:12:24] Speaker 00:
They're not preemptively broad.

[00:12:26] Speaker 00:
They're not just determining however you wish to determine or detecting however you wish to detect.

[00:12:31] Speaker 00:
You must use these fragments and you must do it only this way and that's all these claims cover.

[00:12:38] Speaker 00:
And I would also, I would further say in response to an earlier question that

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You know, methods of diagnosis, it's true that the preamble of the claim is cast in those terms.

[00:12:48] Speaker 00:
But methods of diagnosis are not a suspect class of invention.

[00:12:53] Speaker 00:
They're still methods.

[00:12:55] Speaker 00:
And as long as there are concrete steps, then the presence of a natural law somewhere within the larger claim does not make the method any less

[00:13:09] Speaker 00:
eligible simply because it's a diagnosis.

[00:13:11] Speaker 04:
I have a housekeeping question for you.

[00:13:13] Speaker 04:
Are you also asserting claim six?

[00:13:15] Speaker 00:
We are asserting claim six.

[00:13:20] Speaker 00:
We asserted it.

[00:13:21] Speaker 00:
The district court did not address it.

[00:13:24] Speaker 00:
To the extent the district court did address it, it's just sort of lumped it in with claims seven to nine.

[00:13:31] Speaker 00:
And the court's reasoning with respect to claim seven to nine simply doesn't apply.

[00:13:37] Speaker 04:
There are some statements in the record to the effect of plaintiffs need additional discovery to determine whether defense are infringing claim six.

[00:13:46] Speaker 04:
Athena will focus on claims seven through nine and to a lesser extent claim six.

[00:13:51] Speaker 04:
So your point is that you don't really know what the status is of claim six, but it's still in play right now.

[00:13:57] Speaker 00:
That's right.

[00:13:57] Speaker 00:
And Mayo itself treated Claim Six separately in its briefing.

[00:14:02] Speaker 00:
So there's no question that all the parties understand that these are different technologies.

[00:14:08] Speaker 00:
And the district court should have rendered a separate decision with respect to Claim Six, but did not.

[00:14:16] Speaker 03:
Let's hear from the other side.

[00:14:17] Speaker 03:
We'll save you rebuttal time.

[00:14:19] Speaker 00:
Thank you very much.

[00:14:25] Speaker 03:
Mr. Senior.

[00:14:27] Speaker 01:
Good morning.

[00:14:28] Speaker 01:
May it please the court?

[00:14:29] Speaker 01:
Jonathan Singer for the Mayo parties.

[00:14:33] Speaker 01:
Council said that the inventors came up with a, quote, new assay.

[00:14:38] Speaker 01:
But the novelty here rests, to the extent the novelty is relevant, in the natural relationship that was discovered.

[00:14:45] Speaker 01:
And what the patent states about the new assay that was allegedly discovered is as following.

[00:14:51] Speaker 01:
And I'm quoting at column three, lines 33 to 37, appendix 44.

[00:14:57] Speaker 01:
It says that the actual steps of detecting autoantibodies in a sample of bodily fluids may be performed in accordance with immunological assay techniques known, per se, in the art.

[00:15:13] Speaker 01:
And then, in respect to iodination, it talks about it being a standard technique in the art, the details of which may be found in references four and six.

[00:15:23] Speaker 04:
I hear your adversary to be saying that

[00:15:26] Speaker 04:
This is talking about general principles.

[00:15:29] Speaker 04:
But then when the inventors actually went to implement these techniques, there was something more to it, something more.

[00:15:38] Speaker 01:
And I understand that's their argument as well.

[00:15:41] Speaker 01:
First off, I'll point out that that isn't in the claims, as the court below found, that the complexity described by their expert, for example, is not in the claims.

[00:15:51] Speaker 01:
The claims simply require these generalized steps.

[00:15:55] Speaker 01:
And this most specific that they get is the iodination.

[00:15:59] Speaker 01:
That is the most specific step, the narrowest step, if you will, Judge Stull.

[00:16:04] Speaker 01:
But the actual complexity is not in the claims.

[00:16:08] Speaker 01:
Moreover, just to be fair, the claims aren't limited to the complexity described, even if you were to somehow read it in.

[00:16:16] Speaker 01:
The claims permit the use of full musk.

[00:16:18] Speaker 01:
So this whole thing of chopping it up into fragments, if you will, and epitopes,

[00:16:23] Speaker 01:
The claims cover musk, epitote, or any antigenic determinant thereof.

[00:16:27] Speaker 01:
So essentially, anything that will bind musk.

[00:16:30] Speaker 01:
So the complexity is not stated in the claims.

[00:16:34] Speaker 01:
It's also not fair to characterize the claims as somehow applying to a fragment of musk only.

[00:16:39] Speaker 01:
But even if that were the case, the fact that there's a non-natural fragment in there, this court and other courts have been through this, the use of, I've been before this court arguing,

[00:16:52] Speaker 01:
that the use of a non-natural material made something patentable.

[00:16:55] Speaker 01:
And that argument was rejected in the Brackett case, where the probes were non-natural fragments of the DNA at issue.

[00:17:03] Speaker 01:
That simply doesn't get you over the hurdle.

[00:17:06] Speaker 03:
So it seems it's not disputed that they have made a contribution beyond what was already known.

[00:17:13] Speaker 03:
So what is the problem with construing their most specific description apparently is?

[00:17:22] Speaker 03:
precisely what's being done, is it not?

[00:17:25] Speaker 01:
The contribution that wasn't known, Your Honor, is the natural correlation that they found.

[00:17:34] Speaker 01:
The specific step, the iodination, if you will, is described by the patent specification as a standard technique in the art.

[00:17:44] Speaker 01:
And Judge Cohen, responding to the point about it being complex,

[00:17:47] Speaker 01:
if you will, the patent specification identifies the admonition as being done in, I think, two lines in column 10.

[00:17:58] Speaker 01:
And where you look at column 10, line 50 to 55, it simply says, and they're talking about the ELISA assay, which is claim six, the ELISA assay used as identified in the above example is difficult to standardize.

[00:18:14] Speaker 01:
And we have tested an alternative assay using immunoprecipitation of I-125 musk.

[00:18:21] Speaker 01:
For this test, the purified extracellular domain of musk is iodinated using I-125.

[00:18:27] Speaker 02:
Is it your view that the correlation between musk and the incidence of these muscular disorders is the natural law, natural relationship?

[00:18:42] Speaker 01:
The correlation of the autoantibody, Judge, yes, absolutely.

[00:18:45] Speaker 01:
That is correct.

[00:18:46] Speaker 02:
And all this adds is the label and immunoprecipitation.

[00:18:52] Speaker 01:
That is correct.

[00:18:53] Speaker 01:
That is all the claims add.

[00:18:54] Speaker 01:
And it's admitted by the specification that these are claims that these are additions, if you will, that are standard or known per se.

[00:19:04] Speaker 02:
So how does one protect the discovery of the relationship between the musk antibody complex and the disease, other than with a Nobel Prize?

[00:19:18] Speaker 01:
The relationship, Your Honor, is not protectable.

[00:19:20] Speaker 01:
That's the answer.

[00:19:21] Speaker 01:
If they want to have a claim to their special method of iodination, they're free to try to get one.

[00:19:28] Speaker 01:
And if there's something special about iodinating or something special,

[00:19:34] Speaker 01:
that requires human intervention in doing this test, they can go get a claim to that and try to articulate it.

[00:19:41] Speaker 01:
But what the law prevents, as it currently stands, is a claim that is directed to a natural law that uses conventional steps to elucidate or observe, if you will, that natural law.

[00:19:56] Speaker 01:
And that's what this claim absolutely does.

[00:19:59] Speaker 03:
Well, they do make, I think, a powerful point

[00:20:03] Speaker 03:
who essentially, because this goes beyond precedent, where it was known what the product was in the blood.

[00:20:14] Speaker 03:
Here to discover the antibodies and the relationship and how to treat it is an advance in the science over precedent.

[00:20:26] Speaker 03:
But you're saying because these are natural products, that ends it.

[00:20:30] Speaker 03:
Why would anyone do this research?

[00:20:32] Speaker 03:
In that case?

[00:20:34] Speaker 01:
Well, Your Honor, in the Ariosa case, the discovery of the fetal DNA was a remarkable discovery from discarded materials.

[00:20:43] Speaker 01:
If you remember from that case, the sera of the mother was typically thrown away.

[00:20:47] Speaker 01:
And the discovery of that fetal DNA was a great discovery.

[00:20:52] Speaker 01:
The patent system has an incentive effect.

[00:20:56] Speaker 01:
There's no doubt about it.

[00:20:57] Speaker 01:
But at the same time, the Supreme Court has cautioned that that incentive effect

[00:21:02] Speaker 01:
We shouldn't tie up the basic tools of scientific research purely for that incentive effect.

[00:21:09] Speaker 03:
But they're not doing that.

[00:21:10] Speaker 03:
This is highly specific.

[00:21:13] Speaker 01:
Well, Your Honor, I beg, I disagree with you in the sense that what they have done is discovered the natural relationship between autoantibodies to musk and myasthenia gravis and preempted and claimed a known method for looking.

[00:21:31] Speaker 01:
at that natural phenomenon, or observing that natural phenomenon.

[00:21:36] Speaker 01:
And that violates the standards elucidated in the... For the diagnosis of a highly specific disease.

[00:21:43] Speaker 01:
That's correct.

[00:21:45] Speaker 01:
And that's the natural association we're talking about.

[00:21:48] Speaker 01:
And to tie that up with a known test violates the strictures of Mayo and the AMP case, as well as this court's authorities in

[00:21:59] Speaker 01:
at Cleveland Clinic, for example, as well.

[00:22:03] Speaker 02:
You're saying this is medical research, not product development.

[00:22:07] Speaker 01:
Fair enough.

[00:22:08] Speaker 01:
I think that's one way of phrasing it, Judge Lurie.

[00:22:12] Speaker 01:
And I think that I'm not going to comment.

[00:22:16] Speaker 01:
I'm not going to opine about incentives one way or the other, whether the incentives in our society exist enough to do medical research versus patents.

[00:22:24] Speaker 01:
They both have their role.

[00:22:25] Speaker 01:
Which one is better?

[00:22:26] Speaker 01:
They both have their role.

[00:22:27] Speaker 02:
I would simply... Now, if this had been claimed as a kit containing musk and immunoprecipitating agent with instructions to add this to bodily fluid and combine them, that would be an article of manufacture, perhaps based on this discovery.

[00:22:55] Speaker 01:
it would be an article of manufacture.

[00:22:57] Speaker 02:
And that would be patent-eligible.

[00:22:58] Speaker 01:
Well, you know, I don't know.

[00:23:00] Speaker 01:
I would have to, to be honest, think about that further.

[00:23:03] Speaker 01:
But I think that comes close to the line of, again, applying a conventional test, if conventional technology to this.

[00:23:12] Speaker 01:
If, Judge Lurie, the steps were related to the difficulties they claim, which the patent doesn't support, but to the extent that there are difficulties in doing this and the kit

[00:23:24] Speaker 01:
solve those difficulties, then I think I would agree with you.

[00:23:28] Speaker 01:
But simply a kit that has a standard assay in it for detecting?

[00:23:34] Speaker 02:
Yeah, but the musk is new.

[00:23:36] Speaker 01:
No, no, no.

[00:23:37] Speaker 01:
Musk is not new.

[00:23:39] Speaker 01:
That is a little confusing.

[00:23:41] Speaker 01:
But the autoantibody is for this purpose.

[00:23:44] Speaker 01:
Agreed.

[00:23:45] Speaker 01:
Agreed.

[00:23:45] Speaker 01:
That it's new for this purpose.

[00:23:47] Speaker 04:
The musk antibodies are new.

[00:23:49] Speaker 01:
The musk autoantibodies are new.

[00:23:50] Speaker 01:
That's correct.

[00:23:51] Speaker 01:
Sorry, sorry.

[00:23:52] Speaker 01:
Just being just being a type or technical there.

[00:23:54] Speaker 01:
Sorry about that.

[00:23:54] Speaker 04:
It's good for you to be.

[00:23:57] Speaker 04:
It seems to me that the dispute here is whether the claims are directed to one aspect which is the natural law of the correlation between MG and the musk antibodies or whether it's also it's possible you agree of course that a patent could have multiple different

[00:24:21] Speaker 04:
things to which it's directed, like if in fact the claims were directed not only to the natural law, but also to something else, for example, the technique of creating this musk autoantibody.

[00:24:37] Speaker 01:
The claims could certainly have multiple purposes.

[00:24:40] Speaker 01:
I think in fairness to the lower court judge, the specification, I think, tells us what these claims are directed to.

[00:24:51] Speaker 01:
with respect to its statement at column, let me find it for you, column two, which really just depicts claim one.

[00:25:03] Speaker 01:
And it's claim two, excuse me, specification column two, line 61 to 65, which is essentially claim one of the patent.

[00:25:12] Speaker 01:
And there is provided by a first aspect of the present invention, and that first aspect is what's ultimately claimed.

[00:25:19] Speaker 01:
a method of diagnosing neurotransmission disorders in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of the muscle-specific tyrone kinase musk.

[00:25:33] Speaker 01:
So that's what the claims are directed to, a method of diagnosing the neurotransmission disorder based on the presence of the autoantibody to musk.

[00:25:43] Speaker 01:
That's what these claims are directed to, and that's what the district court so found.

[00:25:49] Speaker 01:
Unless there are further questions, I can address very briefly claim six.

[00:25:53] Speaker 01:
We raised it, Your Honor, Your Honors.

[00:25:57] Speaker 01:
They said it sort of wasn't at issue with respect to they wanted further discovery to see whether or not they would assert it, which from my client's perspective means it's at issue.

[00:26:08] Speaker 01:
It was briefed by us.

[00:26:11] Speaker 01:
They did not raise arguments in response with respect to claim six.

[00:26:16] Speaker 01:
So I think the district court

[00:26:19] Speaker 01:
was within its power to say that that claim was invalid as well.

[00:26:25] Speaker 01:
I think also in the first briefing, I hopefully can provide the appendix site.

[00:26:34] Speaker 01:
In the first briefing, they said that many of the arguments with respect to claim seven through nine applied to claim six as well.

[00:26:44] Speaker 01:
In the first set of briefing, which is where they actually said something about it,

[00:26:48] Speaker 01:
And then in the second set of briefings, they said nothing at all about it.

[00:26:52] Speaker 01:
So they responded, if you will, to Mayo's arguments the first time around, and then didn't respond at all the second time around.

[00:27:01] Speaker 01:
And so I think the district court was proper to assume that that's all they had to say, and that the order with respect to Claim 6 is proper as well.

[00:27:13] Speaker 03:
Any more questions?

[00:27:14] Speaker 03:
Any further questions?

[00:27:17] Speaker 03:
Thank you, Mr. Senior.

[00:27:18] Speaker 01:
Thank you, Your Honor.

[00:27:27] Speaker 00:
So to find that these claims are directed to the relationship between myasthenia gravis and the presence of musk autoantibodies in serum is really to violate exactly the oversimplification concern in deer, cells direct, and macro, and vanda.

[00:27:48] Speaker 00:
It's in there, right?

[00:27:49] Speaker 00:
I mean, the inventors discovered a correlation between

[00:27:52] Speaker 00:
myasthenia gravis, and these autoantibodies.

[00:27:56] Speaker 00:
And that's a good thing, because now a whole population of previously undiagnosable patients can be diagnosed, and fortunately, in the case of MG, treated.

[00:28:05] Speaker 00:
But just because there's a natural law in a claim doesn't mean that the entire claim is directed to the natural law.

[00:28:12] Speaker 00:
And just as in Cells Direct, in which the inventors discovered that these liver cells, these hepatocytes, could survive a second round of freezing

[00:28:22] Speaker 00:
and thawing.

[00:28:24] Speaker 00:
And then they applied that invention to a method that was freezing and thawing the cells a second time.

[00:28:30] Speaker 00:
But this court found those claims eligible because they applied a natural law.

[00:28:34] Speaker 00:
Same thing in Deere, right?

[00:28:36] Speaker 00:
And Deere said, you can't claim the Arrhenius equation on its own.

[00:28:40] Speaker 00:
But if you're using that equation in some new and useful method, then that doesn't disqualify the claim from eligibility.

[00:28:50] Speaker 00:
And here, the inventors discovered that correlation

[00:28:53] Speaker 00:
and came up with the very first musk autoantibody detection method known.

[00:29:01] Speaker 00:
And in order to get there, they have to figure out where the antibodies bound and how to make these fragments in those cases in which fragments are used so that they can be in serum where musk would never naturally be so that they can be detected and so that there's no interference with the specific binding.

[00:29:21] Speaker 00:
None of that existed before.

[00:29:23] Speaker 00:
unlike the earlier cases like Cleveland and Mayo and so forth, where all the methods for doing the so-called steps were not only known, but in use for those particular reasons already, which is why they were claimed at this very high level of generality that bordered on an abstraction.

[00:29:40] Speaker 00:
That is, determine whether there's MPO or determine

[00:29:46] Speaker 00:
whether there are these thiopurine metabolites.

[00:29:48] Speaker 00:
And I'm not going to tell you how, because I didn't come up with a method for it.

[00:29:52] Speaker 00:
What I came up with is the correlation.

[00:29:53] Speaker 00:
You find out, and then guess what?

[00:29:55] Speaker 00:
Apply my correlation.

[00:29:56] Speaker 00:
That's not eligible.

[00:29:58] Speaker 02:
You mentioned Claim 6.

[00:30:02] Speaker 02:
The way I read Claim 6 is all it has in it is a whereby clause.

[00:30:07] Speaker 02:
And it's dependent upon claim three, which is detection.

[00:30:19] Speaker 00:
Right.

[00:30:19] Speaker 00:
And then it goes back to claim two, which requires these antigenic determinants.

[00:30:24] Speaker 00:
Right.

[00:30:25] Speaker 00:
And so that's the key to claim six.

[00:30:26] Speaker 00:
I do want to respond also to this question about whether the presence of a man-made element

[00:30:34] Speaker 00:
changes what might otherwise be an ineligible claim to an eligible one.

[00:30:39] Speaker 00:
And Mayo says, well, BRCA, the BRCA case, the Ambry case took care of that because they already had this synthetic DNA and it was ineligible.

[00:30:48] Speaker 00:
But the synthetic DNA in that case mirrored exactly the natural sequence.

[00:30:54] Speaker 00:
When you have something non-natural, as we do here, either labeled musk or a whole step beyond that, these musk fragments,

[00:31:03] Speaker 00:
Then you were in this Court's AMP 1 decision, 689, 1303, and I think it's worth quoting.

[00:31:15] Speaker 00:
By definition, operations, even known types of steps on transformed subject matter, is the stuff of which most process or method invention consists.

[00:31:25] Speaker 00:
Applying various known types of procedures to transformed subject matter is not merely applying conventional steps to law of nature.

[00:31:35] Speaker 00:
And that's what we have here.

[00:31:36] Speaker 00:
You can't, you know, as far as man-made goes, we are in AMP1 and not in AMPRE because there's nothing natural about what we have synthesized.

[00:31:48] Speaker 00:
And Judge Stoll, you asked earlier whether our method works only for

[00:31:54] Speaker 00:
for musk, and that's interesting because the court relies in part on the references in the patent that describe the previous MG diagnostic method for acetylcholine receptors.

[00:32:06] Speaker 00:
And we know from Dr. DiTomasso's declaration, which the court invited and then ignored, that the acetylcholine test, also immunoprecipitation, also from iustinia gravis, cannot be modified to work for musk.

[00:32:21] Speaker 00:
It won't pick up the musk autoantibodies.

[00:32:24] Speaker 00:
And they use a snake venom toxin for the label to bind to the receptor of interest.

[00:32:32] Speaker 00:
And we don't.

[00:32:33] Speaker 00:
There's no toxin.

[00:32:34] Speaker 00:
It won't work that way.

[00:32:35] Speaker 00:
So the answer to your question, in short, does not work.

[00:32:38] Speaker 00:
It does work only for musk.

[00:32:40] Speaker 00:
It's new and useful.

[00:32:43] Speaker 03:
Thank you.

[00:32:43] Speaker 03:
Any more questions?

[00:32:45] Speaker 03:
More questions?

[00:32:46] Speaker 00:
Thank you very much.

[00:32:47] Speaker 03:
Thank you both.

[00:32:47] Speaker 03:
The case is taken under submission.