[00:00:00] Speaker 00:
1-019-INO Therapeutics versus Praxair.

[00:00:04] Speaker 00:
Mr. Waxman, good morning.

[00:00:12] Speaker 03:
Good morning.

[00:00:12] Speaker 03:
May it please the court?

[00:00:15] Speaker 03:
Malancrot's method of treatment claims are directed to a new and improved protocol for treating gravely ill neonates.

[00:00:24] Speaker 00:
Well, let me just be clear.

[00:00:25] Speaker 00:
I understand.

[00:00:26] Speaker 00:
I'm sorry to interrupt.

[00:00:27] Speaker 00:
The method of treatment is no treatment.

[00:00:30] Speaker 03:
No, the method of treatment is an integrated step, is a series of integrated diagnostic and treatment steps in which a neonates with hypoxic respiratory failure are given a specific diagnostic test to determine whether they have preexisting left ventricular dysfunction.

[00:00:50] Speaker 03:
And depending on the outcome of that diagnostic test are given one of two specifically specified treatment protocols.

[00:00:59] Speaker 03:
One is the administration of, in addition to other things that are done for these gravely ill children, to give them 20 parts per million of inhaled nitric oxide.

[00:01:10] Speaker 03:
And that was in the prior arc, right?

[00:01:11] Speaker 03:
That was in the prior arc.

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And the discovery in this case that came out of the INOD 22 study was that neonates with hypoxic respiratory failure that

[00:01:25] Speaker 03:
have pre-existing left ventricle disorder are gravely at risk for pulmonary oedema if they are administered this as part of their regimen.

[00:01:34] Speaker 02:
Suppose the claims here had said, consider whether to treat these children with LVD.

[00:01:50] Speaker 03:
Yes, Your Honor.

[00:01:51] Speaker 02:
Would that have been patent eligible?

[00:01:53] Speaker 03:
No, that would have been non-patent eligible under Mayo, because as Justice Breyer explained for the court in Mayo, diagnostic claims that merely, quote, inform the audience about certain laws of nature while, quote, trusting the audience to use those laws appropriately are directed to the law of nature.

[00:02:16] Speaker 03:
But the opinion goes on to say, a patent claiming a treatment method

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quote, such as a new way of using an existing drug, remains patentable.

[00:02:28] Speaker 02:
So the difference- So do you agree that it has to be a new way of using a drug?

[00:02:32] Speaker 03:
It has, well, the, a new way of using a drug, which I think would include- Does have to be a new way.

[00:02:41] Speaker 03:
Well, it has to be a new, it has to achieve a new and useful end under the,

[00:02:49] Speaker 03:
section not only under 102 and 103, but under the case law that is built up under Mayo and Myriad and Alice.

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That is, it has to.

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In other words, the difference between your honors hypothetical and this one is the fundamental difference that this court has repeatedly recognized between a patent claim that recites a discovery and trusts the relevant

[00:03:18] Speaker 03:
person of ordinary skill in the art to use the knowledge, the information conveyed in the claim in the best appropriate way, and patent claims that go further and that apply the discovery for a new and useful end.

[00:03:34] Speaker 02:
And the difference- So what does that mean, then, that in MAYA itself, if the claims, instead of saying consider altering the treatment, it said instead alter the treatment

[00:03:46] Speaker 02:
to give more or less depending on the blood levels that that would then have been patent eligible?

[00:03:53] Speaker 03:
I think that would have been patent eligible.

[00:03:55] Speaker 03:
This is a stronger case because this involves an affirmative proactive step that is the testing for pre-existing LVD that didn't exist in Mayo where everybody was being treated with thiopurine.

[00:04:10] Speaker 03:
But I do think that the import

[00:04:13] Speaker 03:
Justice Breyer's opinion in Mayo, in which he makes clear that he is not addressing the latter situation.

[00:04:20] Speaker 02:
That wouldn't leave much of Mayo, would it?

[00:04:23] Speaker 02:
And wouldn't it be quite different than Mayo structure would be quite different from the Alice structure under those circumstances?

[00:04:31] Speaker 03:
I don't really think so, because the first test in Mayo is, I mean, I think for two reasons.

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Hope I don't forget the second one.

[00:04:41] Speaker 03:
Well, the first reason is there's a huge difference in preemptive scope.

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The main concern that Mayo was concerned about is patenting the discovery, patenting the observation, preempts anybody from coming up with further treatments, other, for example, other metabolite levels to take the actual example in Mayo.

[00:05:05] Speaker 03:
In this case, if all that was being patented was the observation,

[00:05:11] Speaker 03:
of the law that do these steps to observe whether the neonate with hypoxic respiratory failure has pre-existing LVD, any scientist, any physician who did that in an attempt to come up with a different or more efficacious treatment regimen would be infringing the patent, whereas here and in all

[00:05:38] Speaker 03:
claims that add specific treatment steps, there is nothing whatsoever that prevents the scientific community with coming up with other ways of helping neonates with hypoxic respiratory failure and LVD.

[00:05:54] Speaker 00:
But just so I understand it, you're not contending that you invented a new way of detecting LVD?

[00:06:04] Speaker 03:
No.

[00:06:04] Speaker 03:
That is, the patent itself recites that there were pre-existing ways, including echocardiography, to determine whether somebody has left ventricle dysfunction.

[00:06:15] Speaker 03:
What the patent claims that is novel is the importance, indeed necessity, of conducting this proactive test before administering INO, which was not in the prior art.

[00:06:27] Speaker 03:
The prior art was, if you have a neonate, if the neonate has hypoxic respiratory failure,

[00:06:33] Speaker 03:
administer this.

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And this is what was novel here is a form of, Judge Dyke, what you were describing in a 103 context in Prometheus Labs versus Roxanne.

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That is, quote, singling out a particular subset of patients for treatment may reflect a new and useful invention that is patent eligible despite the existence

[00:07:00] Speaker 03:
of prior art or prior art patent disclosing the treatment method to patients generally.

[00:07:05] Speaker 04:
Well, just to pursue this thought, are you suggesting that the line is drawn depending on whether that specificity is in the claim rather than in the disclosure, that it's insufficient if it's in the specification in general?

[00:07:29] Speaker 04:
but that if it's moved into the claim, we then cross the barrier, solve the Section 101 problem, and move only into 103?

[00:07:41] Speaker 04:
I'm trying to understand.

[00:07:44] Speaker 03:
There are lines to be drawn.

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Our position is this.

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And I think this is embedded in the Supreme Court's cases going at least back to Funk Brothers.

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That is, there is a fundamental difference for 101 purposes.

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between a claim that recites a new discovery and leaves it to the discretion of practitioners how to apply that discovery and a claim that applies that new discovery for a specific new and useful end.

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For example?

[00:08:20] Speaker 02:
I think it's hard to read Mayo that way because Mayo itself and Myriad and Alice later on made clear

[00:08:28] Speaker 02:
that merely telling someone to apply the discovery, it doesn't make it patent eligible.

[00:08:35] Speaker 02:
And in a way, that seems as though that's what this situation is.

[00:08:40] Speaker 03:
Well, I think you've identified the crux of the issue.

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It was the crux of the dispute between the majority and the dissent in the recent Vanda decision.

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I think that my understanding of Mayo, and frankly, I think this circuit's understanding of Mayo now,

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is that there is a difference between doing the here is a new discovery, go ahead and apply it, which Justice Breyer explained is like Einstein telling the operators of a nuclear acceleration lab.

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Here is my theory of special relativity.

[00:09:17] Speaker 03:
Keep that in mind when you conduct your functions.

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As opposed to here is a theory of the theory of special relativity.

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do the following, x, y, and z. The scope of preemption between those two things is vastly different.

[00:09:35] Speaker 03:
And the nature of the claim, that is, what this court has said over and over again, looking at Mayo is, in all of its diagnostic cases, says, look, the beginning and the end of the process here is the same.

[00:09:50] Speaker 03:
It's information.

[00:09:51] Speaker 03:
It's, as Your Honor said, in the,

[00:09:56] Speaker 03:
genetic technologies versus Myriad case, quote, the product of the method of the claim is information, close quote.

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It was not a new and useful way of applying the information.

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Similarly, in the Bracca case of this court, the court said, quote, the claim recites nothing more than the abstract mental steps necessary to compare two different nucleotide sequences.

[00:10:23] Speaker 03:
element of the claim, there was no aspect of the invention that said, now go ahead and apply this in this new and useful way.

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And that, I understand, is the distinction in the law.

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And I think it's the distinction that has to be drawn.

[00:10:38] Speaker 02:
But the problem then is what's left of Mayo if the claims would have been patent eligible if they had said,

[00:10:48] Speaker 02:
take this into account and increase or decrease the dosage depending on the natural law.

[00:10:55] Speaker 02:
And if it had done nothing more than that, your view is that it would have made it patent eligible.

[00:11:03] Speaker 03:
Well, and I think your honor keeps phrasing it as what would be left of Mayo?

[00:11:09] Speaker 03:
There would be nothing more.

[00:11:10] Speaker 03:
The point that the Supreme Court was making in Mayo was to- It would just depend on how you drafted the claims.

[00:11:15] Speaker 02:
You could get around Mayo.

[00:11:17] Speaker 02:
by drafting the claims the right way and yet Mayo charges us not to let it turn on the draftsman's art.

[00:11:25] Speaker 03:
Well, it is true that you can't let something turn on the draftsman's art and a treatment step at a sufficient level of generality

[00:11:36] Speaker 03:
You could say that Mayo was, this court has said that Mayo involved a diagnostic claim, but you could also say it involved a treatment, a method of treatment in which the specified method was articulated at such a high level of generality that it is not patent eligible.

[00:11:55] Speaker 03:
But I think if one thinks about the concern, the reason for the judge made doctrine limiting the broad scope of 101,

[00:12:04] Speaker 03:
is a concern about preemption, about preempting further discovery.

[00:12:10] Speaker 03:
And the difference between a claim that says here is an observed law of nature that may have consequences in the real world, apply it accordingly, is categorically different than a claim that says here is a new law of nature.

[00:12:28] Speaker 03:
And with that new law of nature, you need to do the following integrated things.

[00:12:33] Speaker 03:
You need to find this population.

[00:12:35] Speaker 03:
You need to test this population in this way.

[00:12:38] Speaker 03:
And then you need to selectively administer a treatment protocol.

[00:12:43] Speaker 02:
The consequence of... Yeah, if there were a new treatment protocol, and you said, well, if you discover this blood level, give this level of treatment.

[00:12:54] Speaker 02:
If you discover another level, give that

[00:12:57] Speaker 02:
level of treatment, that might be different.

[00:13:00] Speaker 02:
But just to say, take it into account and adjust the level of treatment, depending on what you find, that seems to be hard to say that that would be patent eligible.

[00:13:13] Speaker 03:
Let me answer this question and aspire to save some time for rebuttal.

[00:13:18] Speaker 03:
The only difference with respect between the claimant issue in this case and the claim that was held patent eligible subject matter in

[00:13:26] Speaker 03:
is that in Vanda, the differential treatment involved with respect to a particular select subsection of the population, the administration of a lower dose depending on the observation.

[00:13:39] Speaker 02:
Which was found to be novel and not conventional and to be itself a discovery.

[00:13:45] Speaker 02:
So two points here.

[00:13:46] Speaker 03:
There is nothing conventional, utterly nothing conventional

[00:13:52] Speaker 03:
about withholding one of the few lifesaving therapies from a neonate with hypoxic respiratory failure.

[00:14:03] Speaker 03:
More conventional would be what was claimed and held patentable in Vanda, which is give them a lower dose.

[00:14:11] Speaker 03:
The point here is that the difference between something that says if you do this test and if you find a particular result

[00:14:20] Speaker 03:
you administer between 12 milligrams and below, or if you find this, you do something more dramatic and don't administer at all, suggests that if the claim in this case had said, if you find pre-existing LVD, administer a dosage of INO of 0.001%, that can't be the law.

[00:14:42] Speaker 03:
I see after a second.

[00:14:43] Speaker 00:
Your time is running out, but why don't you spend a couple minutes talking about the other issue in this case with the DISR patents?

[00:14:49] Speaker 03:
Sure.

[00:14:50] Speaker 03:
In large part, we're happy to rely on the briefing in this case.

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But on infringement, our fundamental position is that the court interpreted the DSIR claims in a way that contradicts their plain meaning and the specification, and importantly, wouldn't even read on our own commercial embodiment.

[00:15:09] Speaker 03:
The claim refers to, quote, a memory to store gas, close quote.

[00:15:15] Speaker 03:
And then it recites other components, quote, in communication with the memory that receives signals and, quote, verifies one or more of gas identification, gas concentration, and that the gas has not expired.

[00:15:30] Speaker 03:
The claim language, and this relates to the construction of verification, the claim language is about verifying the gas that is stored in the memory.

[00:15:40] Speaker 03:
It does not require, and indeed,

[00:15:42] Speaker 03:
To my knowledge and my client's knowledge, there is no actual way of verifying in real time the gas that is actually in the cylinder.

[00:15:53] Speaker 00:
Thank you.

[00:15:54] Speaker 00:
Thank you.

[00:15:54] Speaker 00:
We'll restore some of the bubble time.

[00:16:04] Speaker 00:
Good morning.

[00:16:13] Speaker 01:
Your Honor, these patents do not claim a new method of using an existing drug.

[00:16:25] Speaker 01:
They simply claim not treating a subset of patients with that drug.

[00:16:30] Speaker 00:
Why isn't that a legitimate discovery if you conclude that these patients should not be taking the drug?

[00:16:36] Speaker 00:
Is that any different than if you conclude

[00:16:38] Speaker 00:
these patients react badly, so we should give them a smaller dosage than we give other people.

[00:16:44] Speaker 01:
Yes, Your Honor.

[00:16:45] Speaker 01:
The distinction is absolutely critical.

[00:16:48] Speaker 01:
And let me start with the Mayo framework, which is, Mayo holds that to transform an unpatentable law of nature into a patent-eligible application, a patent must do more than simply state the law of nature while adding the words, apply it.

[00:17:03] Speaker 01:
I don't believe that Mayo can be read to hold that applications of laws of nature in treatment

[00:17:09] Speaker 01:
are eligible for patent protection unless they are accompanied by an inventive concept that transforms that law of nature.

[00:17:17] Speaker 02:
I guess maybe the difference between the two situations is that in one, the treatment decision that is not to treat flows necessarily from the law of nature, whereas in the second situation, the particular dosage doesn't perhaps necessarily flow from the law of nature.

[00:17:36] Speaker 01:
Yes, your honor and Chief Judge, that was the answer I was about to give to your question.

[00:17:41] Speaker 01:
I was not trying to avoid it.

[00:17:42] Speaker 01:
We don't believe that instruction not to treat patients would be an inventive concept that transforms that law of nature.

[00:17:51] Speaker 01:
The contrast here with the claims in Vanda is truly striking.

[00:17:56] Speaker 01:
Like the patentee in this case.

[00:17:57] Speaker 02:
But I guess the problem is that the particular dosage

[00:18:01] Speaker 02:
might also be said to, in your hypothetical, might also be said to flow from the law of nature.

[00:18:08] Speaker 02:
The law of nature says, shows you that one dose is okay and another dose is not okay.

[00:18:15] Speaker 02:
So is that really a distinction from the treat, don't treat situation?

[00:18:21] Speaker 01:
Yes, Roman, I believe it is.

[00:18:23] Speaker 01:
Because the law, there are two different ways that a law of nature can operate.

[00:18:27] Speaker 01:
There's obviously all patents, as the Supreme Court has recognized, depend on the operation of laws of nature.

[00:18:35] Speaker 01:
Mechanical devices depend on physical forces such as friction.

[00:18:38] Speaker 01:
Any type of method of treatment relies on a fundamental level of the physical reaction of the body to certain doses.

[00:18:46] Speaker 01:
But this law of nature here that these claims are directed to isn't this mechanical

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law of nature that's used to accomplish a result.

[00:18:55] Speaker 01:
The law of nature is the observation of a risk, the purportedly novel recognition of the link between left ventricular dysfunction and pulmonary edema.

[00:19:04] Speaker 01:
Now, the patentees in Vanda identified a similar risk.

[00:19:08] Speaker 01:
They identified a risk condition for cardiac problems for patients who were poor metabolizers.

[00:19:16] Speaker 01:
But what they didn't, Vanda, is not stop there.

[00:19:20] Speaker 01:
What they went on to do was develop a specific treatment for those poor metabolizers based on the risk.

[00:19:26] Speaker 01:
As the court said, the claims in Vanda were directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.

[00:19:38] Speaker 01:
And when you look at what the inventor in Vanda believed that they invented, I'd urge you to look at the Vanda-Appalese brief where they discuss what the inventive concept was.

[00:19:48] Speaker 01:
And what they said is,

[00:19:49] Speaker 01:
very consistent with what I'm saying today.

[00:19:52] Speaker 01:
They said, yes, they recognized the risk.

[00:19:54] Speaker 01:
But the inventive concept was determining the resultant dosages that could safely and efficaciously treat these poor metabolizers and in claiming the specific administration of those dosages.

[00:20:05] Speaker 01:
It was the specific method of treatment that the claims in Vanda were directed to.

[00:20:10] Speaker 01:
And that specific method of treatment was the inventive concept that those inventors added to the natural law of the risk that they recognized.

[00:20:19] Speaker 01:
And Chief Judge Prost will also say the difference between treatment and non-treatment is also critical for the preemptive effect of these claims.

[00:20:28] Speaker 01:
My friend suggested that these claims would not hinder the development of additional treatments.

[00:20:33] Speaker 01:
But imagine that a company like Brexair took the risk that mal and fraud identified, the link between LVD and pulmonary edema, and decided to go

[00:20:43] Speaker 01:
and invest money and invent a new treatment for these patients.

[00:20:47] Speaker 01:
Treatment with a brand new drug, perhaps treatment with pure oxygen, perhaps treatment with Tylenol, a completely new treatment that doesn't rely on inhaled nitric oxide, that new treatment would practice the claims here because those patients are being excluded from treatment with inhaled nitric oxide.

[00:21:05] Speaker 01:
And the claim says,

[00:21:06] Speaker 01:
exclude them from treatment with inhaled nitric oxide.

[00:21:09] Speaker 01:
What it's truly covering is any treatment other than nitric oxide.

[00:21:13] Speaker 02:
Oh, I think we might fix that problem by interpreting the claims so it wouldn't cover the new content.

[00:21:21] Speaker 01:
Perhaps you are, although I think it's unusual to claim inaction, to claim not doing a particular step rather than doing a particular step.

[00:21:30] Speaker 01:
With respect to the relationship of the excluding step and the natural law,

[00:21:34] Speaker 01:
I think it's worth looking at the district court's finding here, that excluding these patients is no different than stating the law of nature and adding the words applied.

[00:21:43] Speaker 01:
You see that on appendix page 27.

[00:21:45] Speaker 01:
And I think you have to recognize that in light of the record that was in front of the judge's slate.

[00:21:51] Speaker 01:
Now, as you'll recall, this is an ande case, an abbreviated new drug application.

[00:21:56] Speaker 01:
Malancroth's theory of infringement at the trial court was, as it had to be,

[00:22:01] Speaker 01:
that by selling a generic version of inhaled nitric oxide, Praxair was inducing doctors to practice these method claims, including the excluding step.

[00:22:11] Speaker 01:
But when you look at the label that would be sold with Praxair's version of inhaled nitric oxide, notably you don't see the instruction to exclude.

[00:22:21] Speaker 01:
What you see there is the label informing doctors about the link between left ventricular dysfunction and pulmonary edema.

[00:22:29] Speaker 01:
Malincrot's arguments to the district court

[00:22:31] Speaker 01:
was that by telling doctors about that link, doctors would necessarily begin excluding these patients from treatment.

[00:22:38] Speaker 01:
Their expert, Dr. Rosenthal, testified that this exclusion was implicit in telling doctors about the natural law.

[00:22:46] Speaker 01:
Similarly, in trying to establish that this link between LVD and pulmonary edema was non-obvious, their expert, one of their witnesses, sorry, Dr. Wessel, who was involved in the I-022 study,

[00:22:57] Speaker 01:
said, well, of course we didn't know about this link between LBD and pulmonary edema.

[00:23:03] Speaker 01:
If we had known about this link, we would have been negligently or intentionally harming children, not to exclude them.

[00:23:10] Speaker 01:
Malin Kraut's case at trial involved arguments that doctors that knew about the link between LBD and pulmonary edema would exclude these patients.

[00:23:21] Speaker 01:
The district court, I don't think, are in finding that,

[00:23:27] Speaker 01:
excluding these neonates from treatment was nothing more than telling doctors to apply this natural law in the course of their treatment.

[00:23:35] Speaker 01:
And there's certainly no suggestion here there was anything inventive about it.

[00:23:38] Speaker 01:
I'd actually encourage you to look at the inventor's testimony about the source of the exclusion step.

[00:23:43] Speaker 01:
You'll see this on appendix pages 1497 to 1499.

[00:23:48] Speaker 01:
There's a fairly long discussion of recognizing the link between

[00:23:53] Speaker 01:
left ventricular dysfunction, pulmonary edema, and other serious adverse events.

[00:23:58] Speaker 01:
But what you won't see is any sort of analysis, any sort of invention goes into, we have recognized this link.

[00:24:05] Speaker 01:
What should we do next?

[00:24:07] Speaker 01:
The inventor simply says, well, we recognize this risk.

[00:24:10] Speaker 01:
So of course we exclude them.

[00:24:12] Speaker 01:
One is left with the sense, what else could we do?

[00:24:15] Speaker 01:
Unless the panel has further questions about the 101 issues.

[00:24:18] Speaker 00:
No, but before you move on, if you're going to move on to the infringement question, can I just ask you a housekeeping question, which is the breadth of the district court's judgment here to cover all of the patents as opposed to identifying the claims that were actually asserted in dispute?

[00:24:34] Speaker 00:
Are we all in agreement that that was overbroad?

[00:24:38] Speaker 00:
It may have been, certainly it was inadvertent, but that that's a problem.

[00:24:43] Speaker 01:
Your Honor will certainly leave to the panel's discretion whether to render a judgment limited to the assertive claims.

[00:24:50] Speaker 02:
Well, the only basis for sustaining the judgment would be that there's a race-judicata effect on these other claims, which would seem to be an issue for a later case and not for this case.

[00:25:00] Speaker 01:
Certainly, Your Honor.

[00:25:00] Speaker 01:
Chief Judge Prost, I cannot seriously dispute that.

[00:25:03] Speaker 01:
We set forth with the erratable basis in the briefing.

[00:25:06] Speaker 01:
With respect to the device claims,

[00:25:08] Speaker 01:
I don't actually believe there's any need to address my friend's verification arguments.

[00:25:13] Speaker 01:
With respect to the cylinders, the district court held that the cylinders that we sold were not reasonably capable of infringing the claims at the time of sale.

[00:25:27] Speaker 01:
That was not challenged on appeal.

[00:25:29] Speaker 01:
That is an independent basis not tied into the verification construction on which there could be no direct infringement.

[00:25:37] Speaker 01:
And as the district court noted with no direct infringement, there can be no indirect infringement.

[00:25:42] Speaker 01:
And then similarly, with respect to the Knox Box I device, the district court not only found that the device did not satisfy the verify limitation, the district court also concluded that there was no communication of the gas data.

[00:25:58] Speaker 01:
You see that on appendix page 41, and I don't believe that's been attacked on appeal either.

[00:26:03] Speaker 01:
With respect to whether there was a verification,

[00:26:05] Speaker 01:
We don't see this as a claim construction issue.

[00:26:07] Speaker 01:
My friend didn't press a construction verify below.

[00:26:12] Speaker 01:
The question was whether district court in a bench trial can conclude that there was no verification under the plain and ordinary meaning of verification.

[00:26:21] Speaker 01:
Here, the alleged verification involved two volumes that had the same source being stored in, excuse me,

[00:26:31] Speaker 01:
being stored in separate places in memory in the Knott's box at the high end.

[00:26:36] Speaker 01:
And those two values being compared against each other, I think the district court as a fact finder didn't clearly err in concluding that there was no verification when a value was simply compared to itself.

[00:26:49] Speaker 01:
Unless the panel has further questions, I'll happily yield.

[00:26:59] Speaker 03:
I just have three points.

[00:27:01] Speaker 03:
One goes directly, I think, to Judge Dite's question to me and first question to my friend, which I think, which I understand, embeds the observation that, well, perhaps if withholding this drug simply flows from the natural law itself.

[00:27:19] Speaker 03:
I want to explain why I think that's not a fair means for distinguishing between patentable and not patentable claims.

[00:27:28] Speaker 03:
And in any event, it's not an accurate characterization of what, in fact, was necessarily discovered.

[00:27:36] Speaker 03:
First of all, if you discover something that helps, you discover that aspirin helps headaches or chemotherapy helps cancer, the most natural thing to do is to apply it.

[00:27:49] Speaker 03:
But we don't deny patent eligibility on the grounds that the discovery of something new, if applied, is the most natural thing to do in light of the discovery.

[00:28:00] Speaker 03:
Second of all, withholding INO, which is one of the few means of treating these gravely ill neonates, is not the most obvious thing to do.

[00:28:15] Speaker 03:
Among the many other ways you could

[00:28:17] Speaker 03:
Assuming the science clears this out, and contrary to my friend's representation, there would be nothing preemptive in this claim from PraxAir figuring out and demonstrating that you can just give a lower dosage.

[00:28:34] Speaker 03:
You can separate out the dosing times.

[00:28:37] Speaker 03:
You can administer the regular dose along with another product, another therapeutic agent that mitigates the risk of LVD.

[00:28:47] Speaker 03:
All of those other things may turn out to be an efficacious way to balance somebody.

[00:28:54] Speaker 03:
It is not the most obvious thing for a physician in the NICU who concludes, if I don't give INO, this baby will die as a certainty in my medical judgment.

[00:29:06] Speaker 03:
And so this is simply not a case in which withholding flows from the natural law itself.

[00:29:14] Speaker 03:
And finally, with respect to my friend's observations about what would or would not amount to infringement of this claim, the district judge didn't address infringement, either direct or contributory or induced infringement with respect to this claim.

[00:29:32] Speaker 03:
And presumably, if this court reverses the determination of under 101, we will have an adjudication about whether or not

[00:29:44] Speaker 03:
If this and a step, there is, in fact, an infringement.

[00:29:47] Speaker 03:
We think there is, but it's not before this court.

[00:29:50] Speaker 03:
Thank you.

[00:29:51] Speaker 03:
Thank you.

[00:29:51] Speaker 00:
We thank both sides, and the case is submitted.

[00:30:00] Speaker 00:
The next case for argument is 18-1172, Sony Corporation versus Yomoku.