[00:00:00] Speaker 04:
The case this morning is 2018-1295 Natural Alternatives versus Creative Compounds.

[00:00:10] Speaker 04:
Mr. Bell, please proceed.

[00:00:11] Speaker 03:
Good morning, may it please the Court.

[00:00:20] Speaker 03:
My name is Kevin Bell.

[00:00:21] Speaker 03:
I represent Natural Alternatives, the appellant in this matter.

[00:00:25] Speaker 02:
In the gray brief, I'm just housekeeping, really, in the gray brief,

[00:00:30] Speaker 02:
23 note 4, page 23 note 4, you argue the 947 patent is part of this appeal because, quote, creative brought the eligibility of that patent into question.

[00:00:41] Speaker 02:
But in your complaint, you didn't assert the 947 against any of the defendants involved.

[00:00:46] Speaker 02:
It's only in a different civil action, right?

[00:00:50] Speaker 03:
Your Honor, the 947 patent was asserted in an earlier filed case against a company called All Max Nutrition.

[00:00:56] Speaker 03:
It is in this opinion because it was asserted against the other defendant high-tech pharmaceuticals and their related entities.

[00:01:07] Speaker 02:
So it's part of this appeal?

[00:01:09] Speaker 02:
Well, yeah.

[00:01:11] Speaker 03:
As I said, this is a housekeeping question.

[00:01:14] Speaker 03:
And a fine question, I believe.

[00:01:16] Speaker 03:
It is not a patent that was asserted against Creative Compounds, the equity in this case.

[00:01:21] Speaker 03:
By virtue of the fact that we appealed the district court's order and it was incorporated, it's been argued.

[00:01:26] Speaker 03:
In this appeal, whether or not you have to pass judgment on it, I think is a decision that the court can make.

[00:01:35] Speaker 03:
But it is not a patent that was inserted against creative compounds.

[00:01:38] Speaker 02:
So the district court's judgment said all of the claims against all of the parties in this action has been resolved.

[00:01:45] Speaker 02:
So isn't it proper to read that the judgment is not invalidating the claims of the 947 patent?

[00:01:54] Speaker 03:
Well, the 947 patent was asserted against the other defendant in another case, but it was the motions were argued on the same day and issued one opinion.

[00:02:05] Speaker 04:
So the one opinion addressed both defendants and all of the patents?

[00:02:09] Speaker 03:
That's correct, Your Honor.

[00:02:10] Speaker 03:
What's the status of the high-tech litigation?

[00:02:13] Speaker 03:
The high-tech litigation originally there were other claims involved in that case, so it proceeded on other claims.

[00:02:22] Speaker 03:
However,

[00:02:23] Speaker 03:
The owner of the company in that case came under federal indictment by the FDA for selling adulterated products, and the government seized all of his records.

[00:02:33] Speaker 03:
So that gave us a convenient way to stay the case for a period of time, I guess, because he had nothing to produce a discovery.

[00:02:39] Speaker 03:
That case is currently, we've been having status, had had status governments with Judge Huff in that.

[00:02:44] Speaker 03:
We eventually reached a point where she was encouraging us to try to dismiss the case, but there's a dismissal with the right to readdress

[00:02:52] Speaker 03:
to bring that case back.

[00:02:53] Speaker 03:
So it was dismissed.

[00:02:55] Speaker 03:
It has been dismissed, but it has conditions upon being able to come back.

[00:03:00] Speaker 04:
Not dismissed with prejudice.

[00:03:02] Speaker 03:
Yeah, that is correct.

[00:03:03] Speaker 03:
I see.

[00:03:03] Speaker 03:
Yeah, it's an interesting set of facts that outside the question.

[00:03:07] Speaker 03:
We didn't have to argue about electronic discovery, which was a plus.

[00:03:16] Speaker 03:
Natural Alternates believes that really this case can turn upon

[00:03:20] Speaker 03:
a discussion of step one of the Alice Mayo analysis.

[00:03:24] Speaker 03:
We believe there were meaningful limitations, at least about five, ignored by the district court.

[00:03:29] Speaker 03:
And any of these meaningful limitations, and certainly the multiple ones that were ignored by the district court, would have ended the analysis under step one.

[00:03:42] Speaker 03:
I can provide you with those limitations and discuss them, so I think that would be beneficial.

[00:03:46] Speaker 03:
Because what we believe is that the district court really

[00:03:50] Speaker 03:
decided to say the focus is on beta alanine.

[00:03:55] Speaker 03:
But what we don't believe is that she looked at the focus on the claim as a whole.

[00:04:00] Speaker 03:
She looked at the focus on the claim as a whole, as is required.

[00:04:04] Speaker 03:
We believe that the other limitations and steps involved in this family of patents would have resulted in a different result.

[00:04:16] Speaker 03:
We also have a claim destruction here that's been stipulated to, and while the judge said she adopted it, it doesn't appear it was applied.

[00:04:23] Speaker 03:
But in any event, we feel that this court failed to adequately consider at least five meaningful claim elements.

[00:04:29] Speaker 02:
Would you explain something to me?

[00:04:30] Speaker 02:
Yes.

[00:04:31] Speaker 02:
In the 596 patent, Table 7 depicts a chart of maximal voluntary isometric contraction.

[00:04:40] Speaker 02:
What is maximal voluntary isometric contraction force, and how does it measure

[00:04:45] Speaker 02:
Caroncine synthesis.

[00:04:50] Speaker 03:
Your Honor, I'm going to plead this to you right now.

[00:04:53] Speaker 03:
You've picked the one person that is the political science major to answer that question.

[00:04:58] Speaker 04:
No, your client did.

[00:05:02] Speaker 03:
Correct.

[00:05:03] Speaker 03:
So you're going to explain it to me, right?

[00:05:05] Speaker 03:
I will find a way to more accurately explain that definition, if I can, Your Honor, to you, if I could, in just a bit.

[00:05:14] Speaker 03:
You can do it on your response.

[00:05:20] Speaker 03:
Thank you.

[00:05:20] Speaker 03:
Yeah.

[00:05:21] Speaker 03:
The effective or the meaningful claim elements that we distinguish were not considered by the district court are the following.

[00:05:31] Speaker 03:
The fact that this is a supplement that is provided to humans, not other mammals.

[00:05:36] Speaker 03:
It is a dietary supplement in the form that is given to humans, giving them effective amounts of things

[00:05:44] Speaker 03:
which would involve various doses.

[00:05:46] Speaker 00:
Well, let's look at claim one of the 08-4 patent.

[00:05:52] Speaker 00:
And the question is, what are the claims directed to?

[00:05:57] Speaker 03:
So claim one of the 08-4 patent would be a human dietary supplement.

[00:06:03] Speaker 03:
So it's a supplement taken by humans.

[00:06:06] Speaker 03:
It provides a dosage regimen to be taken with a range of programs.

[00:06:12] Speaker 00:
So you have the supplement.

[00:06:14] Speaker 00:
And it comprises of beta-alanine.

[00:06:18] Speaker 00:
And I think we can pretty much say that that's a natural substance, correct?

[00:06:24] Speaker 03:
I think we can say that that is a substance that may naturally occur in the body and in the liver.

[00:06:31] Speaker 00:
Okay, good.

[00:06:31] Speaker 00:
So it's a natural substance.

[00:06:33] Speaker 00:
It occurs in the body and the liver.

[00:06:36] Speaker 00:
Then we have a unit dosage of this natural substance.

[00:06:40] Speaker 00:
It's between 0.4 grams and 16 grams.

[00:06:44] Speaker 00:
which seems to be a pretty widespread.

[00:06:48] Speaker 00:
There's no specificity there, but it's a widespread.

[00:06:52] Speaker 00:
But either way, whether you have 0.0001 grams or you have 1,000 grams of this substance, it's still a natural substance.

[00:07:03] Speaker 03:
Well, beta-aluminum is really the natural supplement, if you will, here.

[00:07:07] Speaker 03:
It's really the development of carnosine.

[00:07:09] Speaker 00:
Beta-aluminum is... But we're looking at claim.

[00:07:13] Speaker 00:
We're looking at the claim.

[00:07:14] Speaker 00:
Okay.

[00:07:15] Speaker 00:
So, so far, and you're with me, that this is a natural substance and you have either a handful of .4 grams or you have 16 grams of it.

[00:07:27] Speaker 00:
It's still a natural substance.

[00:07:30] Speaker 00:
Nothing's changed.

[00:07:31] Speaker 00:
We're in the supplement provides a unit dosage of the substance.

[00:07:37] Speaker 04:
Just out of curiosity, I definitely want you to answer Judge Raina's question.

[00:07:41] Speaker 04:
But does a human liver, a single person's human, does any human being have 0.4 grams of beta-alanine in their liver?

[00:07:47] Speaker 04:
I believe so, Your Honor.

[00:07:48] Speaker 04:
No, the answer is actually no.

[00:07:50] Speaker 04:
No political sciences.

[00:07:52] Speaker 04:
Sorry.

[00:07:52] Speaker 04:
Anyway, keep going.

[00:07:59] Speaker 03:
I'm sorry, Your Honor.

[00:08:00] Speaker 00:
So wouldn't you say, I mean, just looking at that, that this particular claim is directed to a natural substance?

[00:08:08] Speaker 00:
That's all it is.

[00:08:08] Speaker 03:
No, Your Honor, I believe these claims are directed toward... No, claim one.

[00:08:14] Speaker 03:
I understand.

[00:08:14] Speaker 03:
Okay, claim one.

[00:08:15] Speaker 03:
I believe this is, claim one is directed to a dietary supplement that includes the precursor... It doesn't say that.

[00:08:23] Speaker 00:
It's a dietary supplement comprising the whole thing is a beta-alanine, which we say is a natural substance.

[00:08:32] Speaker 00:
And again, whether you have a pound of it or 50 pounds of it, that doesn't matter.

[00:08:36] Speaker 00:
It's still

[00:08:38] Speaker 00:
the natural substance.

[00:08:40] Speaker 03:
Well, that would not be a natural substance in an effective amount to create the... This doesn't talk about... Claim 1 does not talk about an effective amount.

[00:08:50] Speaker 03:
It doesn't talk about... No, Your Honor, but I believe you have to read the claim in light of the specification.

[00:08:55] Speaker 03:
So, I mean, I think when you talk about how you take these and what effective amounts are, if you look at the specification, you're going to find in there places where one of the ordinators is going to

[00:09:05] Speaker 00:
Well, you know, I realize that the specification comes into play, but step one of ALICE is that what is the claim directed to?

[00:09:14] Speaker 00:
And here it's directed to beta-alanine.

[00:09:18] Speaker 03:
It is directed to a dietary supplement provided to humans instead of other mammals or animals or other things.

[00:09:25] Speaker 03:
And it is something that is put into a product as a dietary supplement.

[00:09:28] Speaker 00:
It doesn't say any of that here.

[00:09:32] Speaker 03:
I don't think it has to say that in the actual claim language as to what the form of a dietary supplement is.

[00:09:38] Speaker 03:
It is an ingredient in a dietary supplement that, when taken and adjusted, then goes into the body and mixes with all histidine to create carnosine.

[00:09:50] Speaker 04:
Can I question something?

[00:09:52] Speaker 04:
The word effectively is in there.

[00:09:54] Speaker 04:
You asserted a definition for what effectively meant, which is that it has to increase carnosine content in the muscle.

[00:10:01] Speaker 04:
consistent with the specification.

[00:10:03] Speaker 04:
And the district court in this case said, unless I'm mistaken, that she would accept all of plaintiff's claim constructions for purposes of analyzing.

[00:10:11] Speaker 04:
So I think at this stage, whether I agree with that claim construction or not, the district court's decision is based on that as well as your asserted construction of dietary supplement, right?

[00:10:23] Speaker 04:
So all those limitations are in this claim as

[00:10:26] Speaker 04:
decided by the district court below, whether I would agree they should be or not, that's not the issue.

[00:10:30] Speaker 03:
That is correct.

[00:10:31] Speaker 04:
Everybody agreed that these are the limitations to be applied for purposes of this motion.

[00:10:36] Speaker 03:
That is absolutely correct, Your Honor.

[00:10:45] Speaker 04:
Do you want to save the rest of your time for rebuttal?

[00:10:49] Speaker 03:
Well, I'll just point out the additional limitations that were in the claims

[00:10:56] Speaker 03:
It's provided to humans in the form of dietary supplement.

[00:10:59] Speaker 03:
It is an effective amount that must naturally require doses.

[00:11:03] Speaker 03:
An effective amount has to require a certain amount over a period of time.

[00:11:08] Speaker 03:
And I think those are the most relevant limitations that you have here.

[00:11:11] Speaker 04:
Well, and in the 376 claim, you add glycine, and there's testimony in articles that glycine in combination with an amino acid like beta-alanine increases efficacy.

[00:11:23] Speaker 04:
Isn't there in this record?

[00:11:24] Speaker 03:
Yes.

[00:11:25] Speaker 04:
So that's another limitation of a different.

[00:11:27] Speaker 04:
I mean, we were talking mainly about what is, quite frankly, your hardest claim, the 084.

[00:11:31] Speaker 04:
But there are other claims at issue here in front of us that have more detailed and narrow limitations.

[00:11:36] Speaker 03:
That's what I'm trying to.

[00:11:40] Speaker 03:
OK.

[00:11:41] Speaker 03:
Thank you.

[00:11:41] Speaker 03:
I will reserve this for my time.

[00:11:42] Speaker 03:
I actually don't want to waive any arguments, which I think are already in the briefs.

[00:11:45] Speaker 04:
You can't waive arguments in oral argument.

[00:11:47] Speaker 04:
Don't worry about it unless you affirmatively waive them.

[00:11:50] Speaker 04:
OK, Mr. Roche.

[00:11:59] Speaker 01:
Good morning, Your Honor.

[00:12:00] Speaker 01:
May it please the Court?

[00:12:03] Speaker 01:
All of the claims at issue here begin and end with Beta Alame.

[00:12:06] Speaker 02:
In the red break at 44, you argue that this Court has never granted Skidmore deference to the PTO's guidance document.

[00:12:15] Speaker 02:
There's no reason to start doing so now.

[00:12:17] Speaker 02:
Yes, sir.

[00:12:18] Speaker 02:
In Christensen v. Harris County, the Supreme Court explained

[00:12:22] Speaker 02:
that Skidmore differences applied to, quote, interpretations contained in policy statements, agency manuals, and enforcement guidelines, all of which lack enforcement law.

[00:12:32] Speaker 02:
Why aren't the eligibility, why are the eligibility guidelines different from those interpretive documents that are afforded difference?

[00:12:44] Speaker 01:
I think that certain documents from the PTO, eligibility documents, may be

[00:12:50] Speaker 01:
subject to Skidmore deference, I think certain decisions or directions.

[00:12:56] Speaker 01:
They put it out to the public.

[00:12:58] Speaker 01:
They do.

[00:12:59] Speaker 01:
Again, they put it out to folks who draft patent claims like myself, and they put it out to the examiners as well.

[00:13:05] Speaker 01:
However, I think that these particular guidelines, and again, they change, of course, over time.

[00:13:10] Speaker 01:
Most recently, the PTO issued new guidance based upon this court's vanity decision from last year, for example.

[00:13:17] Speaker 01:
Very recently, in 2019,

[00:13:19] Speaker 01:
guidance came out, and that is, I daresay, fairly different in this particular context.

[00:13:25] Speaker 01:
And that's, I think, part of it.

[00:13:26] Speaker 02:
What about Carnegie Mellon v. Hoffman-LaRocque?

[00:13:30] Speaker 02:
We don't cite Skidmore, but we help PTO guidance on 112's written description requirements or persuasive authority.

[00:13:38] Speaker 01:
Certainly persuasive.

[00:13:39] Speaker 01:
Yes, Your Honor.

[00:13:40] Speaker 01:
And again, it's not something to be ignored.

[00:13:42] Speaker 02:
And Skidmore is the power to persuade.

[00:13:45] Speaker 01:
I think it's more than the power to persuade and in fairness, Your Honor.

[00:13:48] Speaker 01:
I think any deference, I'll just give more deference, is perhaps heightened persuasion, let's say, for lack of a better way to say it.

[00:13:54] Speaker 01:
And obviously, I have surprise, Your Honor, and I don't think that you agree with me, and I understand that.

[00:13:59] Speaker 02:
Nevertheless, I think that the deference spoken of... To paraphrase Justice Holmes, the power to persuade is the power to destroy.

[00:14:09] Speaker 01:
Well said, of course, Your Honor.

[00:14:12] Speaker 01:
Not looking to destroy anything here.

[00:14:14] Speaker 01:
Nevertheless, I think that these particular guidances, this particular guidance is subject in this context that we have before us, is particularly problematic for several reasons.

[00:14:27] Speaker 01:
First, of course, we know that the PTO applies far less reasonable interpretation, whereas the court, such as the district court here, blow does not.

[00:14:35] Speaker 02:
Why doesn't, why in your, in step one,

[00:14:38] Speaker 02:
Yes, sir.

[00:14:39] Speaker 02:
Why didn't the red brief discuss Vanda Pharmaceuticals?

[00:14:43] Speaker 02:
It was decided a couple of months before you filed the red brief.

[00:14:47] Speaker 01:
Your Honor, I wrote the red brief and I will stand here and tell you I didn't.

[00:14:52] Speaker 02:
Are you familiar with it now?

[00:14:53] Speaker 02:
I am.

[00:14:56] Speaker 02:
Okay.

[00:14:56] Speaker 02:
What do you have to say about it?

[00:14:57] Speaker 02:
I think that... Why doesn't Vanda control the outcome here?

[00:15:03] Speaker 01:
I think this case is closer to Mayo and in particular Ariosa than it is to Vanda.

[00:15:08] Speaker 02:
What if we had the same patents we have here, okay?

[00:15:17] Speaker 02:
But the discovery was that beta-alamine supplementation inhibits growth of cancer cells.

[00:15:23] Speaker 02:
Wouldn't that be patentable?

[00:15:31] Speaker 01:
I know this isn't going to be a popular answer, Your Honor, but I'm going to have to say I don't believe it would be.

[00:15:37] Speaker 00:
In that example, would that dosage be administered to somebody other than a cancer patient?

[00:15:46] Speaker 01:
So I want to make sure I understand your question, Your Honor, if I may.

[00:15:49] Speaker 01:
So if, for example, it hadn't said dose 16 grams of beta-alanine to a patient who is not suffering from cancer, by the way, we happen to know that this would cure cancer.

[00:16:03] Speaker 01:
Is that a fair?

[00:16:04] Speaker 00:
No, no.

[00:16:05] Speaker 00:
It's just that in Vanda, the medication was directed to a specific individual, somebody suffering from schizophrenia.

[00:16:13] Speaker 00:
Here, there's nothing here that I can see, or am I correct about this?

[00:16:19] Speaker 00:
This applies to any human.

[00:16:23] Speaker 01:
That is correct, Your Honor.

[00:16:23] Speaker 00:
So it's not a specific patient or a correct?

[00:16:29] Speaker 01:
You are absolutely correct, Your Honor, where

[00:16:32] Speaker 01:
the Vanda majority distinguished Mayo on the specific point that it is, quote, that the claims in Vanda are, quote, directed to a novel method of treating a disease.

[00:16:44] Speaker 01:
Again, a specific human suffering a specific condition.

[00:16:48] Speaker 04:
Whereas in Mayo... But wait a minute.

[00:16:50] Speaker 04:
On page 28, spanning 29 of your red brief, you clearly say that even if it was discovered that beta-alanine could cure Alzheimer's, such a discovery

[00:16:59] Speaker 04:
would not be eligible according to you.

[00:17:03] Speaker 01:
Yes, Your Honor.

[00:17:04] Speaker 04:
So your answer to Judge Raina's question, I think, as I understand it, would be even if it was discovered that beta-alanine could inhibit tumors in cancerous patients, it would not be eligible.

[00:17:13] Speaker 04:
Is that right?

[00:17:15] Speaker 01:
Unless there was something more to it.

[00:17:16] Speaker 04:
Yes or no?

[00:17:17] Speaker 01:
No, it would not, Your Honor.

[00:17:18] Speaker 01:
Just that no, it would not.

[00:17:19] Speaker 04:
No, that would not be eligible.

[00:17:20] Speaker 04:
You could not write a claim that says inhibiting tumor growth in

[00:17:26] Speaker 04:
cancer patients using beta-alanine, you would say that's not eligible.

[00:17:30] Speaker 01:
That is correct, and that's what I would say.

[00:17:34] Speaker 04:
Possibly a step too far.

[00:17:37] Speaker 01:
I think that if we look at the cells direct case, we can get some guidance here.

[00:17:41] Speaker 04:
You want us to go a lot further than Mayo went, and to disregard Vanda, to get to where you want us to go.

[00:17:48] Speaker 04:
Your case isn't decided by Mayo.

[00:17:50] Speaker 04:
You want us to go a little further down the Mayo road, and you want us to distinguish Vanda.

[00:17:56] Speaker 04:
Is that fair?

[00:17:58] Speaker 01:
Yes.

[00:17:58] Speaker 01:
Well, I think the second part is fair, Your Honor.

[00:18:00] Speaker 01:
I think the case does not, I'm not looking to go further than Supreme Court went in Mayo.

[00:18:06] Speaker 01:
I think that Vanda is distinguishable.

[00:18:08] Speaker 00:
Okay, so distinguish it.

[00:18:10] Speaker 01:
Okay.

[00:18:11] Speaker 01:
The case in Vanda, it was directed to a new use as the court there, as the majority there said, it was directed to, the claims were directed to a new way of using an existing drug.

[00:18:22] Speaker 01:
Whereas Mayo, according to the Vanda court,

[00:18:26] Speaker 01:
would optimize an existing natural phenomenon.

[00:18:29] Speaker 01:
That's what we have here, Your Honor.

[00:18:30] Speaker 01:
We are optimizing an existing natural phenomenon.

[00:18:34] Speaker 01:
Beta-alanine, in the existing nature, we've all agreed to that.

[00:18:39] Speaker 01:
It naturally creates kernison.

[00:18:42] Speaker 01:
It naturally obviates tiredness when you're working out.

[00:18:49] Speaker 01:
No one disagrees with any of that.

[00:18:50] Speaker 01:
That's all a natural process.

[00:18:53] Speaker 01:
All that the inventors here discovered was,

[00:18:55] Speaker 01:
If I simply give you more beta-alanine, it turns out that your body will not suffer homeostasis as it does in many situations, in many contexts, with many drugs and with many other natural compounds.

[00:19:12] Speaker 01:
But instead, it turns out, we've discovered, your body goes past homeostasis.

[00:19:17] Speaker 01:
Now, that's not a unique, entirely unique condition.

[00:19:23] Speaker 01:
compounds caused the body to go beyond homeostasis.

[00:19:28] Speaker 01:
And all that they have said was, oh, it turns out we discovered that this is one of those compounds that does that.

[00:19:32] Speaker 01:
Well, that's a natural phenomenon, your honor.

[00:19:35] Speaker 01:
And that's exactly, and that's all this is, is dosing and optimizing much like they did in Mayo, or the claims in Mayo, excuse me.

[00:19:42] Speaker 01:
So as the majority said, in Vanda, where Mayo is an optimization case, Vanda is a new way of using an existing drug.

[00:19:54] Speaker 00:
We are an optimization case.

[00:19:56] Speaker 00:
But the core event was very clear to that.

[00:19:57] Speaker 00:
It involved sampling, genotyping essays, and then specific dosages that depend on the genotype of a patient.

[00:20:07] Speaker 01:
Yes.

[00:20:08] Speaker 01:
All that was in the claims.

[00:20:09] Speaker 00:
Do any of the claims here depend on the genotype of a patient or any specific characteristic of a patient?

[00:20:18] Speaker 00:
Maybe a patient that wants to have a little bit more strength in their muscles

[00:20:23] Speaker 01:
But I think it's a patient who would like to offset fatigue.

[00:20:29] Speaker 01:
So I might say it's a slightly different way, but I agree, Your Honor.

[00:20:33] Speaker 01:
Any one of us can take Carnicin.

[00:20:35] Speaker 01:
Anyone in the room can take Carnicin.

[00:20:37] Speaker 01:
And we're going to have the exact same effect because it happens the same way in human beings.

[00:20:42] Speaker 01:
There's nothing unique.

[00:20:43] Speaker 01:
And there's certainly nothing directed to your point, Your Honor.

[00:20:46] Speaker 01:
There's nothing in the claims directed

[00:20:48] Speaker 01:
Or the specification, I might point out, because of course we should look to the written description in the context of the step one of the analysis.

[00:20:55] Speaker 01:
There's nothing in the written description either that says a specific human suffering from a specific condition, unlike in cases like Vanda, for example, where it was very specific.

[00:21:05] Speaker 01:
Again, CellsDirect is another case that I think is easily distinguishable, where this court found that there was not a one-on-one ineligibility.

[00:21:13] Speaker 01:
Because in CellsDirect, while they did discover a natural phenomenon,

[00:21:18] Speaker 01:
They used that discovery to create a brand new laboratory technique.

[00:21:22] Speaker 01:
And that was the basis itself, Director, for finding that the claims were not patent analogy.

[00:21:27] Speaker 02:
In the red brief at 41, you say that the dietary supplement with beta alanine to increase the levels in muscle tissue only uses admittedly conventional activity.

[00:21:42] Speaker 02:
Yes, sir.

[00:21:43] Speaker 02:
And you cite to the 610 patent at column 1, lines 41 to 44,

[00:21:48] Speaker 02:
which says natural food supplements are typically designed to compensate for reduced levels of nutrients in the modern human and animal diet.

[00:21:57] Speaker 02:
In particular, useful supplements increase the function of tissues when consumed.

[00:22:04] Speaker 02:
What part of that language do you think admits that the patents in suit employ only conventional activity?

[00:22:10] Speaker 02:
If I may, just a moment, your honor.

[00:22:12] Speaker 01:
Yes, sure.

[00:22:14] Speaker 01:
Thank you.

[00:22:15] Speaker 01:
That's why I read it to you.

[00:22:17] Speaker 01:
And that was helpful, Your Honor.

[00:22:19] Speaker 01:
I don't want to deny that, but it's always nice to have it.

[00:22:31] Speaker 01:
Well, I think that is the typically designed language there.

[00:22:36] Speaker 01:
I think there may probably, in fairness, be better citations elsewhere in the sixth century.

[00:22:43] Speaker 02:
So without further factual, based on what you cited me,

[00:22:46] Speaker 02:
Without further factual development of the record, how do we know whether the doses claimed are enough to create an unnatural increase?

[00:22:55] Speaker 02:
Keronocene.

[00:22:57] Speaker 02:
Keronocene, I believe.

[00:22:58] Speaker 02:
Keronocene synthesis.

[00:23:00] Speaker 02:
Do we have any evidence of what is an overloading dose of beta-alanine?

[00:23:07] Speaker 01:
We don't have any evidence outside of what I've put in here and what is in the district court's decision, of course.

[00:23:15] Speaker 01:
regarding what is a quote unquote unnatural, specifically, is it point four, for example, in the claim that's discussed in the opening argument, or is it 16, or is it somewhere in there?

[00:23:26] Speaker 01:
There's nothing specific to that, Your Honor.

[00:23:29] Speaker 01:
While we certainly, at this stage, we're not discussing indefiniteness issues, there is nothing specific to that, or what is a quote unquote effective basis.

[00:23:37] Speaker 01:
Nevertheless, although I think Your Honor may want to follow up.

[00:23:42] Speaker 02:
Well, again, on facts, and that is,

[00:23:45] Speaker 02:
At 39 in the red brief, you say the fact that there's a direct link between karenicine concentration levels on the one hand and the amount of beta alanine administered and the amount of time over which the administration, on the other hand, confirms this is a natural phenomenon.

[00:24:07] Speaker 02:
What evidence supports that assertion?

[00:24:09] Speaker 02:
Why wouldn't you need a fact witness to support that sort of assertion?

[00:24:15] Speaker 01:
Because I think that the patent specification, and it's a shared specification for the most part, and certainly in the substantive context.

[00:24:24] Speaker 01:
So I'll say the patent specification addresses this to a great extent.

[00:24:29] Speaker 01:
And for example, the 596 patents, yeah, count five lines four to 35, which is appendix 659.

[00:24:41] Speaker 01:
So lines which?

[00:24:43] Speaker 01:
It was lines, column five, lines four to 35.

[00:24:49] Speaker 01:
And I've been bringing myself there as well.

[00:24:52] Speaker 01:
There's a long discussion here of how the beta-F-alanine histidine dipeptides are synthesized within the body and goes down into, for example, at line 27, the synthesis and accumulation

[00:25:11] Speaker 01:
in a human or animal body can be increased with an increase in the content within the body of creatine, goes on in the next period of blood plasma concentrations, can be increased by ingestion or infusion of beta-alanine, L-histonine, creatine, or active derivatives thereof.

[00:25:29] Speaker 01:
So I think that the patents themselves, and quite frankly, and I don't think there's any significant dispute here about this amongst anyone, amongst the parties even,

[00:25:40] Speaker 01:
If you ingest beta-alanine, Carnicin is the natural result.

[00:25:46] Speaker 04:
But if you add glycine, the carnagen increases even more, doesn't it?

[00:25:50] Speaker 01:
That's my understanding, yes, Your Honor.

[00:25:51] Speaker 04:
So why wouldn't that take us outside of Parker v. Fluke?

[00:25:54] Speaker 04:
Because you have a combination of drugs that is together causing a greater reaction than any one of them could have caused individually.

[00:26:02] Speaker 04:
So unlike Parker, I think it's Parker v. Fluke, am I remembering?

[00:26:05] Speaker 04:
Not Parker v. Fluke.

[00:26:07] Speaker 04:
Just say it out loud.

[00:26:07] Speaker 04:
Funk Brothers, thank you.

[00:26:09] Speaker 04:
Funk brothers, unlike funk brothers where you just took two bacteria and stuck them together and the only invention was they could be given together in one shot, here you have two different products, both of which are going to act together to cause a result that is greater than they could otherwise.

[00:26:23] Speaker 04:
So why doesn't this take us outside the parameters of funk brothers?

[00:26:26] Speaker 01:
Well, I don't think we have evidence that if I took... Let's look at JA 1063.

[00:26:33] Speaker 04:
I'll call it the Balcom reference, which was attached to the Hoffman declaration.

[00:26:37] Speaker 04:
which expressly says the addition of glycine increases and other kinds of insulin increases the effectiveness of amino acids and it expressly says including beta-alanine.

[00:26:47] Speaker 04:
So what we have here is at least a fact argument presented in evidence before the judge at this pleading stage that says this combination does more than each thing individually would have done.

[00:26:58] Speaker 04:
Page 1063 of the JDA.

[00:27:07] Speaker 01:
Well, I think, and this is obviously specific to the 376 patent.

[00:27:11] Speaker 04:
Correct.

[00:27:13] Speaker 04:
Of course.

[00:27:13] Speaker 04:
Yes.

[00:27:14] Speaker 04:
But no, it's not because, let's be clear, the 084 patent has lots of defendant claims which add glycine also.

[00:27:21] Speaker 01:
Yes, Your Honor.

[00:27:22] Speaker 01:
Offhand, I can't recall that they were asserted or not.

[00:27:24] Speaker 01:
They were asserted.

[00:27:25] Speaker 01:
I accept that.

[00:27:27] Speaker 04:
For some crazy reason, I will never understand they agreed to go on Representative Claim 1, which made no sense to me, but they did.

[00:27:33] Speaker 04:
So anyway, but there are other claims asserted in this case that involve the combination with glycine as well.

[00:27:38] Speaker 04:
So why doesn't that take you outside of Funk Brothers?

[00:27:41] Speaker 04:
You can't possibly tell me, do you, that Funk Brothers stands for the proposition that even when two things are put together and found to have a greater impact than either one could have individually, they're still ineligible?

[00:27:52] Speaker 01:
I'm not going to say that.

[00:27:53] Speaker 01:
Thank God.

[00:27:57] Speaker 04:
Nevertheless, I do think that we have to focus on... And so isn't there at least factual evidence that that's the case here based on what I just directed you to?

[00:28:04] Speaker 04:
And wouldn't that prevent at least judgment on the pleading with regard to the 376 claim?

[00:28:09] Speaker 01:
There were factual issues there and I do not believe it would direct us away from a judgment on pleading.

[00:28:14] Speaker 01:
Why?

[00:28:14] Speaker 04:
Did you offer any contrary factual evidence or should a judge be deciding facts like that at the pleading stage?

[00:28:19] Speaker 01:
We did not.

[00:28:21] Speaker 01:
And what I think that the judge did do and should do is look to what the claims are directed to.

[00:28:26] Speaker 04:
And looking at the whole thing- Is this claim directed to a combination of glycine and beta-alanine?

[00:28:33] Speaker 04:
Yes, ma'am.

[00:28:33] Speaker 04:
And is there evidence at the pleading stage in this case that that combination results in greater efficacy, vis-a-vis that particular article I directed you to, which is in the appendix and was before the district court?

[00:28:44] Speaker 04:
There is evidence that the natural results, naturally occurring results- Would be greater, would be different, would be affected by putting these things in combination.

[00:28:52] Speaker 01:
Agreed, Your Honor.

[00:28:53] Speaker 01:
However, again, that's naturally occurring results.

[00:28:56] Speaker 04:
If that's your argument, then any two elements put together in any pharmaceutical compound cause the natural result of putting those two elements together in a pharmaceutical compound.

[00:29:07] Speaker 04:
And therefore, all pharmaceuticals are now ineligible, if that's your argument.

[00:29:11] Speaker 01:
No, you're an arbitrator in that argument.

[00:29:12] Speaker 04:
Because when you put two things together and they cause something different than when they would each cause individually, that has to be eligible.

[00:29:20] Speaker 01:
I would generally agree, yes, Your Honor.

[00:29:21] Speaker 01:
With the only caveat being, of course, stuck too.

[00:29:23] Speaker 01:
But yes, I generally agree.

[00:29:25] Speaker 04:
No, I get it.

[00:29:26] Speaker ?:
OK.

[00:29:28] Speaker 04:
Thank you for your argument.

[00:29:32] Speaker 04:
You have some rebuttal time.

[00:29:45] Speaker 03:
Often as the case as to when you try to decide when to lay down your sword and set up on your shield as opposed to stand back up on the rebuttal time.

[00:29:54] Speaker 04:
In other words, you're going to sit down now?

[00:29:57] Speaker 03:
Pretty close.

[00:29:57] Speaker 03:
I wanted to make sure that I gave you your maximal contraction question.

[00:30:04] Speaker 03:
In language terms, it's essentially a person flexing a muscle for a period of time.

[00:30:09] Speaker 03:
Okay, thank you.

[00:30:11] Speaker 04:
Excellent.

[00:30:11] Speaker 04:
Okay, I thank both counsels.

[00:30:12] Speaker 04:
The arguments are taken under submission.