[00:00:00] Speaker 02:
Case number 20, 1302, Myland Laboratories Limited against Sanofi Mature IP.

[00:00:07] Speaker 02:
Mr. Reed, please proceed.

[00:00:09] Speaker 01:
Thank you, Your Honor, and may it please the Court.

[00:00:13] Speaker 01:
The fundamental question this case presents is whether the Patent Trial and Appeal Board erroneously found that adding an intentional purpose limitation to an otherwise invalid claim

[00:00:26] Speaker 01:
extended Santa Fe's patent monopoly by 10 years.

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The three independent legal errors committed by the board when it extended Santa Fe's patent monopoly are first, the board applied the wrong legal standard for obviousness.

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Second, the board allowed the addition of a purely mental step to a known method to render the claims patentable.

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This is contrary to principles of both inherent obviousness and patent eligibility.

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Third, for public use, the board improperly failed to consider evidence that was published after the priority date, even though that evidence proved what was written down with specificity before the priority date.

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First and foremost, the legal standard for obviousness.

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In early 2019, this court issued a decision in this case holding that the preamble of the amended claims is limiting.

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and requiring that the method be performed with the intentional purpose of increasing survival.

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Unfortunately, on remand, the board took the intent limitation too far, applying an incorrect legal standard and evaluating obviousness.

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And what is your, what do you believe the correct legal standard is?

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The correct legal standard is that in a situation where there's an intentional purpose limitation,

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The question should be whether a person of ordinary skill in the art reasonably could have expected to succeed in having the claimed intent, the claimed mental state in combination with the other overt physical method steps.

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So you're reasonably, you have reasonable expectation of having this intention regardless of whether the intention itself is reasonable.

[00:02:22] Speaker 01:
No, I think that the intention clearly has to be reasonable, but the... Well, isn't that what the board said?

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The board said you have, you undertake these steps with the intent and that you have a reasonable expectation of accomplishing that intent.

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Yes, that reasonable expectation would be that the intentional purpose would be achieved.

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that that result would be achieved.

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Here, the amended claims do not require the result.

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They do not require increasing survival.

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And this highlights the difference between, for instance, for obviousness, what would be required as opposed to invalidity.

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Sanofi insists that Mylan must prove a reasonable expectation of increasing survival.

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achieving that result to show invalidity.

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But at the same time, Sanofi also argues that the survival result is not a claim limitation, meaning survival results would not be necessary to prove infringement.

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Blackwater law requires that the claim elements be the same for purposes of infringement.

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The board did not say that you would necessarily achieve the result of

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of a greater lifespan, but that you would reasonably expect that you might do so.

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I don't understand what it is you're finding to be problematic there.

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I mean, that's essentially what we have said in other cases, including the prior Sanofi case, did we not?

[00:04:11] Speaker 01:
In the Sonnafee v. Watson case, and I think that's the one you were referring to, the standard was that there be a reasonable expectation that the intentional purpose be achieved.

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There's a huge difference between the facts of that case and the facts of this case, however, because in that case, there was an efficacy requirement.

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The effect, the result was actually a claim limitation.

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In the claim language itself, recited that a patient must receive an effective amount of the drug.

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And the district court, Judge Andrews there construed effective amount as, quote, the amount that achieves that goal, end quote, where the goal was the decreasing the risk of hospitalization.

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So there was this requirement in the claims of actually achieving

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a decreased risk of hospitalization, that efficacy result was a claim limitation.

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Here, there is no claim limitation of achieving the result.

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And so this court's decision in intelligent biosystems, that results not required by the claims are not relevant to reasonable expectation of success, control

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success here has to be measured in terms of achieving what is claimed in the patented issue.

[00:05:37] Speaker 02:
Are you saying that we have different claims?

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The claims are the same, are they not?

[00:05:45] Speaker 01:
I'm not sure if I appreciate the claims that you're referring to Judge Newman.

[00:05:50] Speaker 01:
The claims here are different than they were in the first appeal of this case.

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The original 592 claims were held unpatentable by the board.

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And that, that determination was not appealed by Sanofi.

[00:06:05] Speaker 02:
Okay.

[00:06:06] Speaker 02:
Well, the claims were amended, but it's the same patent, isn't it?

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Right.

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It's the same patent.

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And these claims as amended were presented in the first appeal.

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And this court determined the focus of the first appellate decision was whether the preamble was a limitation.

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And this court held that there is a limitation in this preamble.

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It's the intentional purpose limitation.

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So that's one of two differences between the original claims and these amended claims.

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The two differences being the intentional purpose limitation and then a pretreatment regimen.

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And I think the pretreatment regimen is kind of the tail wagging the dog if we focus on that too much.

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The real question here is focused on the intentional purpose limitation.

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So with this court's guidance that that is a limitation, the question then becomes what is required to establish obviousness?

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And it should be the same thing that would be required to prove infringement.

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And Sanofi argues that... So let me go back to the Sanofi Watson case.

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In there we said,

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that you had to have a reasonable expectation of achieving the result.

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But we didn't say that required actually achieving that result, right?

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So for instance there, if you had a reasonable expectation of a decrease in hospitalization rates from an effective amount of the drug, it would still infringe if in a particular case that didn't happen, right?

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Maybe.

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That may be the case.

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And I think that case and even the claims in this case highlight the uncertainty surrounding what happens in an individual patient.

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In an individual patient, when you administer the drug, it's virtually impossible to tell whether that drug achieved the goal of decreasing the risk of hospitalization because you can't compare the two scenarios where you do and where you don't administer the drug.

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And that highlights what Sanofi here is trying to do with the population study results.

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Here, Sanofi is attempting to say that without the population study results, it would be impossible to know, sorry, to reasonably expect an increase in survival and that what's required is phase three clinical trial results.

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Sanse is effectively seeking a determination that phase three trial results were the only thing that could justify a reasonable expectation.

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And that position is contradicted by this court's prior case law, where for instance... Is that what your own expert said, that before that tropic study, those phase three results, no one would have expected this?

[00:09:05] Speaker 01:
I don't think so.

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I think that the expert that we presented testimony from testified that before the results, persons of ordinary school in the art were expecting the trial to be successful.

[00:09:18] Speaker 03:
No, that's not what he said.

[00:09:21] Speaker 03:
That's not what he said.

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Dr. Sepp was very pretty adamant that he made a strong distinction between hoping that something would happen and expecting something to happen.

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And in fact, he kept correcting

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the questioner during his deposition to make sure that that clarification was made.

[00:09:42] Speaker 01:
That's true.

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And in fact plaintiff's expert, patent owner's expert here, Sanofi's expert, similarly testified that when you're looking at treating a patient with chemotherapy like basitaxel, both back in 2008 before the priority date of this patent and today,

[00:10:05] Speaker 01:
a physician would only have a hope of prolonging survival.

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And based on this testimony, if a hope is not sufficient to reasonably expect that the intentional purpose claim limitation will be met, it wouldn't be enough to practice the claim and no doctor could practice the amended claims even today.

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Now that is an illogical outcome.

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The board specifically addressed that testimony and

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totally disagreed with your interpretation of it and said that Dr. Seth's testimony was very equivocal and did not agree with your characterization of Sanofi's expert testimony.

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So these are fact findings.

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These are fact findings, but they were arrived out in context of what we submit is the wrong legal standard for determining obviousness.

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The legal standard for obviousness has to be commensurate with what would be held, what Sanofi will be held to improving infringement.

[00:11:09] Speaker 01:
It's two sides of the same coin.

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And if a doctor in administering a drug can only hope that administering that drug will actually treat the patient effectively, will achieve

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the intentional purpose, then that physician couldn't, that is exactly what would be required to prove invalidity.

[00:11:36] Speaker 01:
And this highlights, I think, the board's misunderstanding that in this art, in treating cancer patients with chemotherapy, hope for an individual patient was as reasonable an expectation of success as the patent itself provides.

[00:11:53] Speaker 01:
There's no guarantee.

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There's no certainty.

[00:11:57] Speaker 03:
Well, the board was very specific that there's no guarantee for any particular patient.

[00:12:01] Speaker 03:
But after the tropic study, there was a reasonable expectation of achieving that prolonged survival for the patient population with this particular illness, right?

[00:12:17] Speaker 01:
Yes.

[00:12:17] Speaker 01:
Yes, that's right.

[00:12:19] Speaker 01:
So the holding there then is that

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If I could just finish my thought, the holding is that the physician has to have this mental state informed by the phase three clinical trial results.

[00:12:36] Speaker 01:
And only once they have those results can they form the mental state, which highlights the idea that there is,

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a patent ineligible subject matter here, because the only addition to the claims is this mental state from what was previously held invalid.

[00:12:56] Speaker 01:
Unless the court has further questions at this point, I'd like to reserve the remainder of my time for rebuttal.

[00:13:01] Speaker 02:
All right.

[00:13:02] Speaker 02:
Anything else for Mr. Reed at the moment?

[00:13:05] Speaker 00:
No, not now.

[00:13:06] Speaker 02:
We'll save you rebuttal time.

[00:13:09] Speaker 02:
Okay.

[00:13:09] Speaker 02:
Mr. Minion.

[00:13:11] Speaker 00:
Thank you, Your Honor.

[00:13:12] Speaker 00:
May it please the court

[00:13:14] Speaker 00:
One thing I think is important to make clear, Your Honors, Mr. Reed, my colleague, asserted that Sanofi was using a different standard for invalidity and infringement.

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And in Mylan's reply brief, there are places where Mylan asserts that Sanofi agrees that increasing survival is not a claim limitation or that the claims do not require increasing survival.

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which they in turn assert distinguishes the claims here from those in, for example, the Sanofi v. Watson case.

[00:13:49] Speaker 00:
That's not true.

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Sanofi's position is that increasing survival is a part of the claims.

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It's a limitation.

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And so as part of any infringement analysis, it will be Sanofi's burden to prove, among other things, that the use of kibazotaxel according to the claims methods

[00:14:11] Speaker 00:
is life prolonging, right?

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And that will be, burden will be met by primarily looking at the results of the tropics study that show, in fact, the claimed methods do increase survival over the prior therapy.

[00:14:33] Speaker 00:
What the claims do not require, Your Honor,

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nor did they require in the prior cases, is that at each cycle of administration, so cabazotaxel is infused in these patients every three weeks.

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So what the claims do not require is that at each cycle, a physician make a specific determination in an individual patient that that patient would not be alive were it not for the cabazotaxel treatment.

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Now, a physician can make that determination.

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We have from, for example, Dr. Safe, you know, these are patients who have failed all treatment options.

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They're terminally ill with this prostate cancer that's metastatic.

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And as Dr. Safe says, if he has a patient who's living after five cycles of cabazotaxel,

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He says it's safe to say that they're living longer as a result of the therapy.

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Mylan says in their reply brief that, in fact, it's so obvious to tell when a patient is having their life belonged that it's impossible to keep it a secret.

[00:15:50] Speaker 00:
But, you know, that does not mean that at cycles, for example, one, two, or three, the first time to have a tax was given or when it's given three weeks later,

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that the physician is not practicing the claim methods.

[00:16:05] Speaker 00:
They are.

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By virtue of the tropic results, a physician knows that tabasco, according to the claim methods, increases survival in the patient.

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And so by doing so with the requisite intent, they are practicing the claims just as they would from the first cycle to the fifth cycle for however long they do.

[00:16:27] Speaker 00:
That does not mean that they have to guarantee

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that the patient is going to have their survival increase that they're going to live longer or be able to predict.

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And that's why these claims are framed in the way they are.

[00:16:45] Speaker 03:
Do you agree that with your friend on the other side, with respect to his characterization of Dr. Sartor's testimony saying that all he could say was that he hoped

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that the patient's lives would be extended?

[00:17:02] Speaker 00:
I do not agree with that, Your Honor.

[00:17:05] Speaker 00:
And I think, as Your Honor pointed out, that the board looked at that testimony very closely and concluded that that was not Dr. Sartor's position.

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What Dr. Sartor said was, prior to the results of Tropic, yes, as an investigator in the study, he hoped

[00:17:26] Speaker 00:
that it would provide uh... increased survival with the results would show increased overall survival uh... but that after the result of the party he then had an expectation he now have an expectation uh... of increasing survival in these patients and therefore can not only now have the requisite intent of increasing survival uh... you know the the the myelin

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reference to intelligent biosystems.

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And that's the case that the board cited to set forth the legal standard for obviousness here, I think is instructive.

[00:18:07] Speaker 03:
And it has a nice... The point really that the board made is that you always only hope with respect to each individual patient that the results that

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that most of the population in the Tropic Study achieved would be achieved for that particular patient.

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But that doesn't mean that you don't reasonably expect, given the Tropic Studies results, that with respect to the broad base of the population, that any given one would have that chance.

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Any given patient would really have that chance.

[00:18:47] Speaker 00:
I think there, I think, Your Honor, there is area between hope and guarantee.

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And where the mind frame of a person of ordinary skill in the art, considering kebasa tassel treatment and its potential benefit to a patient, where that line falls between hoping and guaranteeing or predicting moves dramatically from the results of tropics.

[00:19:18] Speaker 00:
So having an expectation, which Dr. Sartre

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said he had and the board agreed, that is prerequisite to having the intent of increasing survival of these patients.

[00:19:35] Speaker 00:
So whether the obviousness analysis as to reasonable expectation of success is rooted in reasonable expectation of success itself or in the motivation to combine, at the bottom line,

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the board found, one cannot have an intent to increase survival in these patients without that requisite reasonable expectation that it will.

[00:20:02] Speaker 00:
And that's particularly true here, same as in the OSI, the Apotex case, that you have an entirely unpredictable arc.

[00:20:14] Speaker 00:
You have many failures.

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These are patients who have failed all therapies, including dosataxel,

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which is a taxane similar to cabazitaxel.

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The board noted the skepticism in the arc as to the tropic study.

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The board noted the unexpected results.

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The board again credited Dr. Sartre's testimony that prior treatment methods that had shown to have anti-cancer activity in these patients ultimately failed

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to provide any life extension to these patients when studied in phase three.

[00:20:57] Speaker 00:
One of the things I'd like to address from Mr. Reed is characterizing Sanofi's position that it's only after the results of a phase three study

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that you can render obvious a method of treatment claim.

[00:21:22] Speaker 00:
That's not our position.

[00:21:23] Speaker 00:
That's what our position is here, that there was so minimal information regarding Tabasco's use and potential benefit in light of what I discussed earlier as the unpredictability of the art.

[00:21:38] Speaker 00:
In this particular case,

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that evidence was not sufficient to provide a reasonable expectation of success, which is consistent with the board's findings.

[00:21:50] Speaker 00:
So in that case, yes, it could have been a different scenario where you had a phase two study or you had a teaching in the prior ARV that showed that if you decrease PSA levels in these particular patients or if you

[00:22:11] Speaker 00:
decreased tumor size in these patients, that that would translate into increased survival.

[00:22:18] Speaker 00:
But of course, that's not the case, and that's not what the board found here.

[00:22:23] Speaker 03:
The board found that... Well, the board specifically found that that's not the case, right?

[00:22:27] Speaker 03:
And Dr. Seth, or Seth, I don't know how to pronounce it, but he specifically said that that's not the case, right?

[00:22:35] Speaker 00:
That's correct, Your Honor.

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that those were not surrogates for increase in survival.

[00:22:40] Speaker 00:
Those are very different metrics.

[00:22:42] Speaker 00:
And that is borne out and highlighted very well in the prior art in those studies where in phase two or phase one studies, a particular therapy was found to have anti-cancer activity in terms of partial responses, tumor responses, PSA reductions, but again,

[00:23:06] Speaker 00:
those methods were not found to increase survival.

[00:23:11] Speaker 00:
On the issue of reasonable expectation of success, Your Honor, there's an assertion by Mylan that the board found that, quote, some poses had the intent to increase survival as of the time of the patent.

[00:23:31] Speaker 00:
That's incorrect.

[00:23:32] Speaker 00:
What the board did is they looked at the totality of the evidence and put the evidence in the three different buckets.

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First was the evidence that the board cast as neutral with respect to a finding of reasonable expectation of increased survival.

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Evidence supporting such a finding and then the third bucket evidence opposing such a finding.

[00:23:58] Speaker 00:
On the neutral evidence, the board found that the mere existence of the phase three trial was neutral, that it didn't give an indication that the drug was going to be successful or not.

[00:24:11] Speaker 00:
As this court has held before, a hypothesis does not mean that the outcome is expected.

[00:24:22] Speaker 00:
For the evidence that the board cited for supporting

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a finding of reasonable expectation of increased survival.

[00:24:31] Speaker 00:
The board did cite Mylan's expert Dr. Safe's opinion that he believed the tropic study would succeed at the time and said to the extent he resembled the POSA, which he of course is not the hypothetical person of ordinary skill in the art, the board said that would support a finding of obviousness.

[00:24:51] Speaker 00:
But as Judge O'Malley pointed out, the board found that evidence equivocal

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and weighed that against what the board noted was significant evidence that supported a finding that a post-it would not have expected the claim treatment method to have resulted in increased survival.

[00:25:15] Speaker 00:
On the issues of inherency and public use and the abstract idea

[00:25:26] Speaker 00:
As my colleague Mr. Reed used the phrase that applied to both, that when you're dealing with a known method or in Myland's brief, they refer to, you know, prior art method or a method in the public domain.

[00:25:46] Speaker 00:
And I just wanted to reiterate that the claims at issue here, the steps of the claims,

[00:25:54] Speaker 00:
were not a prior art method.

[00:25:58] Speaker 00:
They were not in the public domain.

[00:26:01] Speaker 00:
And what makes that very clear is there's a chart in pages 36 to 39 of Milan's opening brief that shows where all of the elements are found in the prior art.

[00:26:18] Speaker 00:
And Milan needs no fewer than five different references

[00:26:23] Speaker 00:
to find each of the claim limitations, and that doesn't even get to, of course, the intent limitation.

[00:26:33] Speaker 00:
So this is not an inherency case, and this is not a case where the prior ART had a, or there was a method in the public domain, and there was just an addition of a mental step, as Mylan asserts.

[00:27:00] Speaker 00:
And I think if there are no questions for me, further, Sanofi respectfully requests that the court affirm the board's decision to grant Sanofi's motion to amend.

[00:27:12] Speaker 02:
Anything else for Mr. Minion?

[00:27:14] Speaker 00:
Not for me.

[00:27:16] Speaker 02:
No.

[00:27:17] Speaker 02:
Okay.

[00:27:17] Speaker 02:
Thank you.

[00:27:18] Speaker 02:
And Mr. Reed, you have your last word.

[00:27:19] Speaker 01:
Thank you very much, Judge Newman.

[00:27:22] Speaker 01:
I'd like to focus on what Mr. Minion ended on, and that is the question of inherency.

[00:27:27] Speaker 01:
And whether it's okay for Sanofi to get a patent on the natural result of a public domain method.

[00:27:35] Speaker 01:
Mr. Minion suggested that the method was not in the public, that it was not part of the priority.

[00:27:41] Speaker 01:
When in fact, the result of the original PTAB proceeding in the 2017 final written decision was the board finding that the original claims of the 592 patent were unpatentable.

[00:27:57] Speaker 01:
In other words, they were obvious.

[00:28:00] Speaker 01:
And so we have to look at what is different between what was found unpatentable previously and what was added.

[00:28:10] Speaker 01:
What was added was the intentional purpose limitation and pretreatment regimen.

[00:28:14] Speaker 01:
Those two aspects of the claims are what are different.

[00:28:19] Speaker 01:
And with respect to the preambles limitation, the intentional purpose requirement, the intent to increase survival,

[00:28:26] Speaker 01:
Increased survival is inherent in performance of the administration of cabazotaxile, regardless of what mental state the person administering the cabazotaxile has, and that means that these claims are obvious.

[00:28:42] Speaker 03:
Also... But didn't Dr. Seth specifically say that one would still not have used the specific combination of treatment elements here?

[00:28:56] Speaker 01:
Well, when in deposition, yes, he was asked about whether he would use all three and he said, I think I'd use this one.

[00:29:02] Speaker 01:
But regarding that pretreatment medication regimen, the three components, two points.

[00:29:07] Speaker 01:
First, there's no evidence that those components increase survival in any respect.

[00:29:13] Speaker 01:
Those are side effect alleviators that prevent or control nausea and vomiting and allergic reactions.

[00:29:20] Speaker 01:
And second, the board's 2017 final written decision that was up on appeal before addressed very clearly that pretreatment regimen and held that Milan established that that pretreatment regimen was common.

[00:29:35] Speaker 01:
It was obvious.

[00:29:36] Speaker 01:
So it can't render the claims patentable.

[00:29:39] Speaker 01:
Um, and certainly these claims here are different than the Vanda case where in the Vanda case, the mental state of the physician changed what the physician did.

[00:29:50] Speaker 01:
depending on the results of the determinative step, the manipulative steps, where to either give a high or a low dose of the schizophrenia drug.

[00:29:59] Speaker 01:
Here, the mental state doesn't impact what you do next at all.

[00:30:04] Speaker 01:
It is a purely mental process step.

[00:30:07] Speaker 01:
And the addition of a purely mental process to a prior method is not something that is patent eligible.

[00:30:15] Speaker 01:
I think my time has expired, so unless the court has further questions, we respectfully request

[00:30:20] Speaker 01:
reversal or alternatively vacate and remand for a new decision.

[00:30:25] Speaker 02:
Okay.

[00:30:25] Speaker 02:
Any further questions for Mr. Reed?

[00:30:27] Speaker 02:
Hearing none, the case is taken under submission with thanks to both counsel.

[00:30:37] Speaker 00:
Thank you, your honors.

[00:30:38] Speaker 00:
Thank you, your honor.

[00:30:41] Speaker 03:
The honorable court is adjourned until tomorrow morning at 10 a.m.