[00:00:00] Speaker 04:
The next case for argument is 22-1116, Chromadex vs. Oseum Health.

[00:00:09] Speaker 04:
Take your time.

[00:00:09] Speaker 04:
We're trying to keep everybody distance.

[00:00:13] Speaker 04:
Mr. Medlick, whenever you're ready.

[00:00:15] Speaker 04:
We are.

[00:00:17] Speaker 01:
Good morning, Your Honor.

[00:00:22] Speaker 01:
William Medlick with Lerner David Littenberg, Krumholz and Medlick, Cranford, New Jersey.

[00:00:27] Speaker 01:
here for Dartmouth College and Chromadex, along with my colleagues Russell Feigenberg of my firm and Jason Fowler of Covington.

[00:00:38] Speaker 01:
This case arises from a decision by the district court finding patent ineligibility for claims to compositions formulated for oral administration to treat various disorders to promote health and welfare based on

[00:00:57] Speaker 01:
of fundamental misunderstanding, error, from the district court, which couldn't be more clear than if your honors would refer to the district court's opinion at page 8 in appendix 37.

[00:01:13] Speaker 01:
In there, the court says, it is undisputed that NR, that's nicotinamide riboside, in milk, nicotinamide riboside in milk is a naturally occurring substance,

[00:01:27] Speaker 01:
improves health and well-being, and enhances what's known as NAD plus biosynthesis.

[00:01:34] Speaker 01:
And thus, those characteristics do not distinguish isolated NR, claim calls for isolated NR, which is critical, and the claim composition from NR found in milk.

[00:01:49] Speaker 01:
That statement by the district court was fundamentally wrong.

[00:01:55] Speaker 01:
Elysium's own expert acknowledges that it's wrong.

[00:01:59] Speaker 01:
Elysium itself is very careful.

[00:02:01] Speaker 03:
Can I ask you just to make sure I understand?

[00:02:04] Speaker 03:
You're saying that the NR in milk accomplishes that objective, that that statement is wrong, that it increases NAD plus biosynthesis, right?

[00:02:15] Speaker 01:
NR, yes, your honor.

[00:02:16] Speaker 01:
NR, as it exists in nature, can't do it.

[00:02:19] Speaker 03:
But what does do it is milk as a composition.

[00:02:23] Speaker 03:
Milk is undisputed based on the undisputed facts.

[00:02:27] Speaker 01:
It is undisputed that milk as a complete composition can do it, and it's pretty well known that it is the tryptophan component of milk that is responsible for that.

[00:02:40] Speaker 03:
Your claims, though, as I read them, say that it's the composition that increases Nan plus biosynthesis, right?

[00:02:48] Speaker 03:
It's the composition

[00:02:51] Speaker 03:
Not the isolated NR.

[00:02:54] Speaker 01:
The claim is directed to the composition as a whole.

[00:02:58] Speaker 01:
It does not attribute, nor in our view does it have to contribute, the increase in the NAD plus biosynthesis to a particular component.

[00:03:09] Speaker 01:
The reality is that we have two limitations in the claim which are critical.

[00:03:17] Speaker 01:
One is that the NR must be isolated.

[00:03:19] Speaker 01:
And everyone agrees, and I think in particular, Elysium touts the fact in its advertising, its entire business predicated on any deep, I'm sorry, an NR containing formulations is predicated on the phenomenon discovered by Dr. Brennan that isolated NR is what gives it to you.

[00:03:41] Speaker 03:
The claim doesn't need to say.

[00:03:43] Speaker 03:
Is what gives it to you.

[00:03:44] Speaker 01:
Gives you the increase in the biosynthesis.

[00:03:46] Speaker 03:
I understand, but that's not what your claim requires.

[00:03:49] Speaker 01:
The claim requires that the composition do it.

[00:03:53] Speaker 01:
That's right.

[00:03:54] Speaker 01:
The claim doesn't have to attribute that function to any particular component of the function.

[00:04:01] Speaker 01:
It's a fundamental principle of patent law that there is no essence or heart of an invention.

[00:04:04] Speaker 03:
Let me tell you what I'm concerned about, and then you can address it.

[00:04:07] Speaker 03:
Sure.

[00:04:07] Speaker 03:
Your concern primarily is that I agree, you do have isolated NR, and that differs from MIL.

[00:04:13] Speaker 03:
But it doesn't differ from milk in that milk, it's undisputed that milk increases NAD plus biosynthesis.

[00:04:19] Speaker 03:
And your claim is pretty broad.

[00:04:22] Speaker 03:
Had your claim said, well, your claim is broad, so therefore the only difference, as I understand it, from your claim and the natural product of milk is that your claim requires isolated NR.

[00:04:36] Speaker 01:
It's not the only difference with due respect, Your Honor.

[00:04:38] Speaker 01:
We also have a product formulated for oral administration.

[00:04:43] Speaker 01:
a compound formulated for oral administration.

[00:04:47] Speaker 01:
You can't take the NOR out of the milk.

[00:04:49] Speaker 03:
So where do you have compound, I guess you're thinking of?

[00:04:51] Speaker 03:
I'm looking at claim one of the 807 patent.

[00:04:54] Speaker 02:
But milk is something that everybody consumes and consumes orally.

[00:05:01] Speaker 01:
Correct, Your Honor.

[00:05:02] Speaker 02:
So it's a food.

[00:05:04] Speaker 01:
But we know from Elysium itself that I believe the quote is, you can't consume enough of anything.

[00:05:13] Speaker 01:
that includes the naturally occurring NOR.

[00:05:17] Speaker 02:
That's true, but milk, as we know, has tryptophan.

[00:05:20] Speaker 02:
And as we all know, the tryptophan increases NAD plus biosynthesis.

[00:05:26] Speaker 02:
On some level.

[00:05:27] Speaker 02:
That's right.

[00:05:29] Speaker 03:
Your claim doesn't specify the amount.

[00:05:31] Speaker 03:
I'm sorry for interrupting.

[00:05:33] Speaker 03:
Where in your claim do you say that you have to have so much of this or that?

[00:05:39] Speaker 03:
My concern is that your claim is really broad.

[00:05:41] Speaker 03:
There's no amount

[00:05:42] Speaker 03:
of the isolated NR.

[00:05:44] Speaker 03:
There's no amount of any other component.

[00:05:46] Speaker 03:
It just says that the composition is a whole, and it doesn't say how much you have to have.

[00:05:50] Speaker 01:
That's correct, Your Honor.

[00:05:51] Speaker 03:
Increases add plus biosynthesis.

[00:05:53] Speaker 01:
But we do know from both the National Alternatives case, which relies on the decision in Vanda, that in order to determine the meaning of certain claim phrases, we could look at the specification.

[00:06:05] Speaker 01:
If we look at the specification here, there is nothing in the specification that addresses anything

[00:06:10] Speaker 01:
but isolated NOR as being responsible for the biosynthesis, the NAD plus biosynthesis.

[00:06:20] Speaker 01:
And the claim most clearly says it is formulated for oral administration and increases.

[00:06:27] Speaker 01:
Milk can't do that.

[00:06:29] Speaker 01:
Milk just cannot do that under any circumstances.

[00:06:32] Speaker 02:
Milk can't increase NAD plus biosynthesis?

[00:06:36] Speaker 02:
Not.

[00:06:39] Speaker 02:
Milk can increase.

[00:06:40] Speaker 02:
NAD plus biosynthesis.

[00:06:43] Speaker 01:
But not in a way, Your Honor, that it's not a formulated product.

[00:06:49] Speaker 01:
The NAD, I'm sorry, the NR in milk can't.

[00:06:52] Speaker 01:
And that is what the judge predicated his decision on.

[00:06:55] Speaker 01:
He said it's a naturally occurring phenomenon.

[00:06:58] Speaker 04:
Can you just explain a little your answer?

[00:07:01] Speaker 01:
Sure.

[00:07:02] Speaker 01:
I'm sorry.

[00:07:03] Speaker 01:
The NR, as it exists in milk, is natural.

[00:07:09] Speaker 01:
The isolated NR,

[00:07:11] Speaker 01:
called for by the claim is not a naturally occurring substance.

[00:07:15] Speaker 01:
The NR as it exists in milk, yes, milk as a whole can arguably increase biosynthesis.

[00:07:22] Speaker 01:
But that's not the claim.

[00:07:24] Speaker 01:
The claim is a formulation for oral administration that can increase NAD plus by 5%.

[00:07:31] Speaker 02:
But the claim also recites the elements of milk to the degree that it does

[00:07:39] Speaker 02:
like milk have NR.

[00:07:41] Speaker 02:
I grant you that your claim says the NR is isolated, but also the claim goes on further recites tryptophan, it recites a sugar.

[00:07:48] Speaker 02:
These are things that are all part of milk, and then ultimately wherein the composition increases NAD plus biosynthesis.

[00:07:56] Speaker 02:
We've already agreed that milk increases NAD plus biosynthesis.

[00:08:00] Speaker 02:
So what I'm trying to understand is

[00:08:04] Speaker 02:
it appears that this claim is reciting elements of milk.

[00:08:10] Speaker 02:
And the only difference between the elements recited here in this claim compared to milk is that your NR is isolated compared to milk which doesn't have its NR isolated.

[00:08:25] Speaker 01:
That is correct.

[00:08:26] Speaker 02:
And then the next question is,

[00:08:27] Speaker 02:
What are the markedly different characteristics between your claim composition and milk?

[00:08:33] Speaker 02:
And if you're telling me it's because, well, our NR is isolated, whereas the NR milk is not isolated, I don't know why that is either structurally a markedly different characteristic or functionally a markedly different characteristic.

[00:08:53] Speaker 01:
Well, by having the composition formulated for oral administration, including

[00:08:57] Speaker 01:
isolated NR, not a naturally occurring substance.

[00:09:00] Speaker 01:
The health benefits, the ability to treat or address.

[00:09:06] Speaker 02:
We've already set up and agreed that milk increases NAD plus biosynthesis.

[00:09:13] Speaker 02:
Milk does it in a way that does it.

[00:09:15] Speaker 02:
Milk does it through tryptophan.

[00:09:17] Speaker 02:
You want to say your claim composition does it through the isolated NR.

[00:09:23] Speaker 02:
But your claim construction for isolated NR doesn't have anything in the construction that connects the term isolated NR to any improved health benefits per se.

[00:09:37] Speaker 02:
The claim construction is nothing more than NR that is separated or substantially free from at least some of the other components associated with the source of NR.

[00:09:47] Speaker 02:
In other words,

[00:09:48] Speaker 02:
You could take milk, cow's milk.

[00:09:51] Speaker 02:
You could separate one or two components from milk, as it exists in nature.

[00:09:56] Speaker 02:
And you will have isolated NR under this claim construction.

[00:10:02] Speaker 02:
I don't agree with that, Your Honor.

[00:10:04] Speaker 02:
I don't see, first of all.

[00:10:05] Speaker 02:
Why wouldn't this claim construction permit a reading of isolated NR that entails taking cow's milk

[00:10:15] Speaker 02:
removing a sugar and removing tryptophan, and then that qualifies under this construction for isolated NR.

[00:10:23] Speaker 02:
Because the milk... I just separated two components associated with milk from the NR that's in milk.

[00:10:34] Speaker 02:
Why doesn't that just fit this claim construction cleanly?

[00:10:37] Speaker 01:
Because the NR, as it then continues to exist in milk,

[00:10:42] Speaker 01:
is inextricably bound to the whey protein.

[00:10:45] Speaker 02:
And I do not see anything in your claim construction.

[00:10:49] Speaker 02:
that requires the NR as it exists in milk to be separated from the protein.

[00:10:56] Speaker 02:
All it says is something much more broadly and generically that it has to be separated from at least some of the components.

[00:11:04] Speaker 02:
And there are many, many components of milk, including lactose, including sugar, including tryptophan.

[00:11:10] Speaker 02:
And so I'm at a loss to why I have to, I must read this claim construction

[00:11:16] Speaker 02:
as requiring the NR in milk to be separated from the whey protein?

[00:11:22] Speaker 01:
Let me respond with two answers, Judge Shin.

[00:11:26] Speaker 01:
Number one, even if we accept what you are suggesting, and I do not accept it as a matter of fact under these circumstances, the best we're going to ask different characteristics, which is one of the requirements that we look at in the natural alternatives case,

[00:11:47] Speaker 01:
The claim composition has far different characteristics than milk in terms of its ability, particularly when read because of the bioavailability that isolated NARC gives you, which it does not give you for milk.

[00:12:01] Speaker 01:
But the best we get if we go that route, we have actually two things that happen.

[00:12:05] Speaker 01:
One is you at least have an issue of fact, which some rejudgment should not have been granted.

[00:12:11] Speaker 01:
Number one, but more importantly.

[00:12:13] Speaker 04:
What's the issue of fact?

[00:12:14] Speaker 01:
The issue of fact is.

[00:12:16] Speaker 01:
What is the different characteristics of the claim composition versus milk and its ability to treat diseases?

[00:12:24] Speaker 01:
They're not the same thing.

[00:12:27] Speaker 01:
But again, more importantly, let's get to step two of the Alice analysis.

[00:12:31] Speaker 01:
If we get to step two, step two informs that we have to look for an inventive concept.

[00:12:39] Speaker 01:
No one knew before Dr. Brenner's work that NR,

[00:12:45] Speaker 01:
had the capability, the potential to increase biosynthesis.

[00:12:50] Speaker 01:
We all agree, and there's no dispute.

[00:12:53] Speaker 02:
Does Dartmouth or Chromadex have any patent claims in their respective portfolios that connects isolated NR to the desirable health benefit of increasing NAD plus biosynthesis?

[00:13:09] Speaker 02:
Take it for granted.

[00:13:11] Speaker 02:
based on that hypothetical question that I don't think your claims in this patent connect up isolated NR directly to improved NID plus biosynthesis?

[00:13:24] Speaker 01:
Well, I accept, Your Honor, saying that you don't see that they connect up.

[00:13:32] Speaker 01:
I do not know.

[00:13:33] Speaker 01:
To me, the 807 patent does what you just said.

[00:13:37] Speaker 01:
There's nothing in the 807 patent that attributes the bioavailability and the increase in biosynthesis to anything.

[00:13:47] Speaker 01:
But there is a passage in the patent that says some of the other components maybe can kick it up a little bit more.

[00:13:54] Speaker 01:
But when fairly read in light of the specification, which I do submit,

[00:13:57] Speaker 01:
this court has found in natural alternatives in Vanda.

[00:14:00] Speaker 01:
I think we're a stronger case than either Vanda, where patent eligibility was found, and certainly the natural alternatives.

[00:14:08] Speaker 02:
Again, if I could get back to the claim construction, the isolated NR as construed isn't construed to be an NR separated from its natural source and formulated in a super concentrated amount.

[00:14:27] Speaker 03:
And I would just add that you're not disputing that claim construction on appeal, right?

[00:14:32] Speaker 01:
You're not disputing that claim construction.

[00:14:33] Speaker 03:
Not that aspect of it.

[00:14:35] Speaker 01:
Not that aspect of it.

[00:14:36] Speaker 01:
But realistically, realistically.

[00:14:39] Speaker 03:
But answer Judge Chen's question.

[00:14:40] Speaker 01:
Yes.

[00:14:40] Speaker 01:
If you're going to isolate the NR, NR itself is water soluble.

[00:14:47] Speaker 01:
You can't pull it out of there, out of the milk.

[00:14:50] Speaker 01:
You have to do something to it.

[00:14:52] Speaker 01:
And that was the inventive concept here.

[00:14:53] Speaker 01:
We had to do something to it to concentrate it

[00:14:57] Speaker 01:
So saying that the NR need not be fully separated and it can have perhaps other amounts.

[00:15:04] Speaker 01:
If you do that, the overall composition is not going to increase biosynthesis the way the claim calls for and the way the specification informs.

[00:15:13] Speaker 03:
I'd like to ask you a question about the standing issue and there's some temporary time period

[00:15:18] Speaker 03:
where there's an argument that Comodex lacks standing, right?

[00:15:23] Speaker 03:
But I'm just a little confused about that issue, because of course, the patent owner, Dartmouth, was in the case from the very beginning.

[00:15:32] Speaker 03:
So why is nobody talking about that?

[00:15:34] Speaker 03:
I mean, there is standing.

[00:15:36] Speaker 03:
Somebody has standing.

[00:15:37] Speaker 03:
So I don't understand why this issue was even presented.

[00:15:45] Speaker 01:
issue is really in our appeal because we're preserving a damages issue for hopefully down the road.

[00:15:52] Speaker 03:
So it's not that this case should have been dismissed.

[00:15:56] Speaker 03:
Instead, it was an argument that for some time period, Chromadex wouldn't be titled to lost profits.

[00:16:04] Speaker 01:
Correct.

[00:16:04] Speaker 01:
Yes.

[00:16:04] Speaker 01:
The way the decision reads, Chromadex would be denied the opportunity to get damages for the period following

[00:16:15] Speaker 01:
between the restated agreement, third agreement, and later on.

[00:16:19] Speaker 01:
It's a damages issue, Your Honor.

[00:16:21] Speaker 01:
But we do contend that the Crobodex has that standing predicated on the arguments.

[00:16:26] Speaker 01:
Now, I would note that if we do look at it, I would see my time is up.

[00:16:29] Speaker 01:
Well, your time is up.

[00:16:30] Speaker 04:
Yeah.

[00:16:31] Speaker 04:
Your time is up.

[00:16:31] Speaker 01:
So why don't we have a little course of rebuttal.

[00:16:32] Speaker 01:
I'll save this for rebuttal.

[00:16:33] Speaker 01:
Thank you.

[00:16:35] Speaker 00:
Mr. Young, good morning.

[00:16:37] Speaker 00:
Good morning, Your Honors.

[00:16:38] Speaker 00:
And may it please the Court.

[00:16:40] Speaker 00:
The claims on appeal are not patentable under section 101 because of the stipulated construction below.

[00:16:47] Speaker 02:
Do you agree?

[00:16:48] Speaker 02:
Your opposing counsel led off with a particular statement made by the district court at 837.

[00:16:54] Speaker 02:
Do you agree that that's a misstatement?

[00:16:57] Speaker 02:
I mean, maybe you'll want to argue that that misstatement doesn't make a difference.

[00:17:04] Speaker 02:
But at page 837,

[00:17:07] Speaker 02:
the district court in the lower half said, quote, it is undisputed that NR and milk improves health and well-being and enhances NID plus biosynthesis.

[00:17:19] Speaker 02:
Do you agree that that was a misstatement?

[00:17:23] Speaker 02:
Because it's the tryptophan, of course, in milk that improves NAD plus biosynthesis, not the amounts of NR, which are bound up in whey protein as it exists in milk.

[00:17:38] Speaker 02:
So I think that... So you agree that it's a misstatement?

[00:17:41] Speaker 00:
Well, I don't agree that... How is it not a misstatement?

[00:17:45] Speaker 00:
We do not agree that the NR in milk does not lead to NAD... What about the undisputed part of that sentence?

[00:17:53] Speaker 00:
Yes.

[00:17:54] Speaker 00:
I take your point.

[00:17:55] Speaker 00:
I think that the bigger point, though, is that it is not required.

[00:18:01] Speaker 02:
But let's just get all on the same playing field.

[00:18:04] Speaker 02:
I'm hearing you say you agree that this is not a correct statement.

[00:18:08] Speaker 00:
I believe that Dartmouth and Chromadexta disputed that the NR in milk

[00:18:17] Speaker 00:
leads to NAD plus biosynthesis.

[00:18:19] Speaker 00:
I think it is... What does your side think?

[00:18:22] Speaker 02:
Does your side dispute that?

[00:18:25] Speaker 00:
Yes, Your Honor.

[00:18:27] Speaker 02:
Your expert believes that NR, as it exists in milk, improves NAD plus biosynthesis when you consume milk.

[00:18:36] Speaker 00:
Yes, Your Honor.

[00:18:36] Speaker 00:
I think that there's some argument in the briefs that I think are misleading and don't tell the full story, but ultimately I think that

[00:18:44] Speaker 00:
That question is not relevant because the issue is, as has been pointed out repeatedly this morning, does the composition increase NAD plus biosynthesis?

[00:18:53] Speaker 00:
And they have admitted that the composition increases NAD plus biosynthesis.

[00:18:57] Speaker 00:
So the question of whether or not the NR in the composition increases NAD plus biosynthesis is not relevant.

[00:19:05] Speaker 03:
Do you agree that certain arguments that are made, had they been

[00:19:10] Speaker 03:
like if the claim did say that it's the isolated NNR that provides the NAD plus increase and NAD plus biosynthesis that maybe this could be a totally, that this could be an eligible claim.

[00:19:22] Speaker 00:
I think that natural alternatives provides the roadmap for that kind of a claim, Your Honor, so that if a patent applicant comes forward with evidence that a particular dosage forum with a particular high amount of natural product produces a

[00:19:37] Speaker 00:
unnatural results, you know, possibly using synergies between natural products, then under natural alternatives, that kind of a claim could be patentable.

[00:19:45] Speaker 03:
So had there been a claim that's had an amount of the isolated NR and had the increased function as a result of that amount, then that could have been something that you would agree would be eligible under natural alternatives.

[00:19:58] Speaker 00:
If they can show that it has different characteristics from the natural product.

[00:20:01] Speaker 04:
Well, natural alternatives, all they did was, natural alternatives just rejected a 12b6

[00:20:05] Speaker 04:
dismissal.

[00:20:06] Speaker 04:
So there was a long way to go between that and the conclusion of patent eligibility.

[00:20:11] Speaker 00:
That's correct.

[00:20:12] Speaker 00:
And that was hugely important to the decision because as natural alternatives came up to this court, there had been no claim construction.

[00:20:18] Speaker 00:
And so the court said, we need to review these claims under the patentees' claim construction.

[00:20:25] Speaker 00:
And the patentees' claim construction included things like non-natural effects.

[00:20:30] Speaker 00:
And the court said, under this kind of a claim construction,

[00:20:35] Speaker 00:
the district court judge erred in granting the 12b6 and remanded.

[00:20:39] Speaker 00:
And as the concurring opinion notes, on remand under a correct claim construction, the district court could invalidate the claims under 101.

[00:20:46] Speaker 00:
So the claims of natural alternatives are fundamentally different from the claims at issue in this case, Your Honors.

[00:20:53] Speaker 02:
Under Supreme Court precedent, why were these claims

[00:20:57] Speaker 02:
for determining whether this composition is from a product of nature examined under the Alice Mayo two-step framework, when it should have been examined under the Myriad Inquiry for Composition Claims, which really looked solely at the Diamond v. Chakrabarti markedly different characteristics framework for whether a composition is for a product of nature.

[00:21:24] Speaker 00:
Yes, Your Honor.

[00:21:25] Speaker 00:
Those two lines kind of are happening.

[00:21:28] Speaker 02:
I didn't see the Supreme Court's Myriad opinion, which issued a year after the Mayo opinion, as applying the two-step framework in the Myriad case and examining what the isolated DNA

[00:21:43] Speaker 02:
qualifies under section 101.

[00:21:46] Speaker 00:
Yeah.

[00:21:46] Speaker 00:
Well, I think under either, if you accept the idea that there are differences between those tests, under either test these claims are unpatentable, and Judge Connolly below did cite Myriad and talked about how the fact that you merely isolating a natural product is not enough to establish patentability.

[00:22:01] Speaker 00:
I will note that in natural alternatives, the court did apply an ALICE two-step test, although the court also brought in

[00:22:09] Speaker 00:
the markedly different concept from Diamond vs. Chakrabarti as part of Alice Step 1, so there's a bit of a melding that was happening in that case.

[00:22:17] Speaker 02:
Well, do you think that was correct under the Supreme Court caseload?

[00:22:21] Speaker 00:
I think that... I guess I don't think that Alice... I don't believe that the Alice two-step test was intended to apply to a subset of inventions.

[00:22:33] Speaker 02:
The product of nature type of inquiries.

[00:22:38] Speaker 02:
in alice of course we had there was an abstract idea uh... issue and i don't think that the the alice two-step test applies only to abstract ideas uh... and supreme court president of the lives in there yes and can also applied to structured claims to but we're just talking about one of their subsets when we're trying to ask ourselves whether a claim is directed to a product of nature or not so that was a lot of debt and reach out to party

[00:23:06] Speaker 02:
allowed Marriott, at least for the composition claims.

[00:23:10] Speaker 00:
I guess I still believe that the Alice two-step test applies here, that at step one, there still has to be a fundamental question of what is the focus of this claim, and is it directed to a natural product, and is there anything else in the claim that would allow for an inventive concept?

[00:23:26] Speaker 00:
Arguably, all of those same concerns are addressed in the market lead

[00:23:29] Speaker 00:
different, the test of Diamond versus Chakrabarti.

[00:23:33] Speaker 00:
But again, I think either, and I believe that Judge Connelly below considered both of those things because he specifically cited Myriad.

[00:23:40] Speaker 00:
And under either, these claims are unpatentable.

[00:23:45] Speaker 03:
Do you have anything to add on the standing question?

[00:23:48] Speaker 03:
Why didn't anybody stand up and say, hey, Dartmouth is in the case, so why are we wasting all this time on standing?

[00:23:58] Speaker 03:
I mean, if it's a damages issue, then it's a damages issue to be addressed at the time the damage is raised, not to be addressed as a question of whether the case should be dismissed.

[00:24:08] Speaker 00:
Yes, Your Honor.

[00:24:08] Speaker 00:
So the standing issue was not an issue of should the whole case be dismissed.

[00:24:14] Speaker 00:
The standing issue was really late breaking.

[00:24:16] Speaker 00:
It was a year into the case when Chromadex and Dartmouth amended their license in order to attempt to bring in another company, HealthSpan,

[00:24:27] Speaker 00:
So that health span could make a loss profits argument.

[00:24:30] Speaker 00:
That's a hundred percent what was going on.

[00:24:32] Speaker 00:
And so at that point, again, a year into the case, we opposed a motion to amend the complaint, to bring in health span and simultaneously move to dismiss Chromadex in view of this new license.

[00:24:45] Speaker 03:
Why would Chromadex have to be removed when the patent owner is already in the case with Chromadex?

[00:24:52] Speaker 00:
Well, I mean, Chromadex had to be removed because it didn't have constitutional standing.

[00:24:56] Speaker 00:
But if the question is, well, how does it matter?

[00:24:58] Speaker 00:
It matters mostly to damages.

[00:25:00] Speaker 00:
Because Dartmouth, of course, is an academic institution.

[00:25:02] Speaker 00:
It was seeking a reasonable royalty.

[00:25:05] Speaker 00:
Whereas HealthSpan is making a dietary supplement.

[00:25:09] Speaker 00:
And so they had a lost profits claim.

[00:25:11] Speaker 00:
And Chromadex was trying to piggyback on that and make a lost profits claim itself.

[00:25:17] Speaker 00:
So it was really a damages issue.

[00:25:21] Speaker 00:
The effect of the standing ruling was not to end the case.

[00:25:25] Speaker 00:
The effect of the standing ruling was to say that Chromadex and HealthSpan are not in the case and it continues as to Dartmouth.

[00:25:33] Speaker 03:
It was interesting because I noticed that the district court didn't quite analyze the question of whether Chromadex with HealthSpan together would have standing.

[00:25:44] Speaker 03:
Am I missing that?

[00:25:45] Speaker 03:
Do you think that the court did analyze that?

[00:25:48] Speaker 03:
I believe that the court... I think it looked at them separately, but never together.

[00:25:52] Speaker 00:
Well, I think that the court, I mean, the issue came up in the context of a motion to amend.

[00:25:58] Speaker 00:
And so the question before the court was, should HealthSpan be added to this case?

[00:26:03] Speaker 03:
But once a determination is made that Chromadex alone doesn't have standing, shouldn't the answer be yes?

[00:26:09] Speaker 00:
No, because those questions really go hand in hand.

[00:26:11] Speaker 00:
Whether or not Chromadex has standing and whether or not HealthSpan has standing.

[00:26:15] Speaker 03:
But what if they have standing together?

[00:26:17] Speaker 00:
Well, so I don't think that they can have standing together, Your Honor, because... Who has standing then?

[00:26:23] Speaker 00:
Dartmouth has standing.

[00:26:25] Speaker 00:
And if there was a true exclusive licensee under the case law, that entity could also have standing.

[00:26:34] Speaker 00:
But neither Chromadex nor HealthSpan met the characteristics of that sort of an exclusive licensee.

[00:26:41] Speaker 00:
Therefore, there was no constitutional standing for them to be plaintiffs in this case.

[00:26:46] Speaker 04:
Thank you.

[00:26:47] Speaker 04:
Thank you.

[00:26:48] Speaker 04:
Mr. Mintleck, you exhausted your time.

[00:26:50] Speaker 04:
We'll restore two minutes of rebuttal.

[00:26:52] Speaker 04:
Thank you very much.

[00:26:53] Speaker 04:
Appreciate it.

[00:26:54] Speaker 02:
Just to confirm, and before your time begins, if we were to affirm on the 101, then we need not reach the standing issue.

[00:27:03] Speaker 01:
That's correct, Your Honor.

[00:27:04] Speaker 01:
If you affirm a 101, we're out of court.

[00:27:07] Speaker 01:
Got it.

[00:27:09] Speaker 01:
Now, I think what has been really made clear here

[00:27:15] Speaker 01:
and perhaps we've lost sight of it, is that the issue here is, is the asserted claim or the asserted claims directed to a product of nature?

[00:27:26] Speaker 01:
It's not.

[00:27:27] Speaker 01:
If you want to argue that milk could potentially be prior art that anticipates or renders obvious the claim composition which requires isolated NOR, we're not talking patent eligibility.

[00:27:44] Speaker 01:
there can be no doubt whatsoever that isolated NR is not a product of nature.

[00:27:51] Speaker 01:
So if we get to, and according to the specification, your honor asked, well, where does it tell you that you have enough of this to make the composition

[00:28:04] Speaker 01:
something that will increase NAD plus biosynthesis.

[00:28:07] Speaker 01:
Well, if you read what isolated, through the claim construction, permits isolated NR to be bound up possibly, let's call it some impurities or some of what's left in milk.

[00:28:19] Speaker 01:
But the disclosure, which again I submit both natural alternatives, the specification, both natural alternatives and Vanda permits us and endorses looking to, tells us

[00:28:32] Speaker 01:
a concentration for isolated NR in the composition.

[00:28:36] Speaker 01:
That's one tenth of one percent.

[00:28:38] Speaker 01:
That's a thousand times greater than NR, which is not bioavailable, and there is just no question.

[00:28:46] Speaker 01:
There can be no argument whatsoever as to whether naturally occurring NR, as it appears in milk, is bioavailable.

[00:28:56] Speaker 01:
It's not, to the extent Judge Connolly decided it was, it was wrong.

[00:29:03] Speaker 01:
As to, let's go to step two, if we might.

[00:29:08] Speaker 01:
In Judge Connolly's opinion on page 12, he quotes our expert that the inventive concept is the pioneering decision to create a composition comprising isolated and R-formulated for oral administration.

[00:29:22] Speaker 01:
It's not well understood, and on and on.

[00:29:25] Speaker 01:
Now, what does Judge Connolly say?

[00:29:26] Speaker 01:
Judge Connolly says that all Chromadex did, all Dartmouth did, Dr. Brenner did, was uncover that.

[00:29:34] Speaker 01:
But that wasn't a principle of nature.

[00:29:37] Speaker 01:
It was not a principle of nature that isolated NR could have these characteristics.

[00:29:43] Speaker 01:
So to characterize, if you get past step one, which we still contend we should win at step one, excuse me, and you get to step two, to suggest that there's no inventive concept here, when what Dr. Brenner did here was recognize it, recognize the benefits of it, and create a product

[00:30:04] Speaker 01:
that has capabilities and potential for significant utility which you can't get from anything in the prior art, certainly not milk.

[00:30:15] Speaker 02:
Just to confirm, your argument hinges on us looking at the term isolated NR as it's used in this claim, and to think about that term as requiring not only separation of NR from other elements in milk,

[00:30:34] Speaker 02:
but also to think about how it also has a concentrated amount of NR as it exists in milk.

[00:30:45] Speaker 02:
We need to think about both of those things when we're looking at this term in this claim.

[00:30:49] Speaker 01:
To some extent, Your Honor, yes.

[00:30:52] Speaker 01:
The only way I would modify that is that I can understand and appreciate the suggestion that the claim is so broad because it doesn't give you a concentration.

[00:31:01] Speaker 01:
But again, if you look

[00:31:04] Speaker 01:
If we had NR in milk, it's not an isolated, not a natural product.

[00:31:09] Speaker 01:
Concentration has to have the potential for significant utility.

[00:31:14] Speaker 01:
It has to do something different.

[00:31:16] Speaker 01:
That's what was recognized that did not exist in any prior product before Dr. Brenner's work.

[00:31:24] Speaker 01:
So in that sense, we are saying that if you evaluate the claim and look at it

[00:31:32] Speaker 01:
as requiring the composition as a whole, requiring increased NAD plus synthesis, and you look at it in light of the specification, you could only get that with the claim formulation, not milk.

[00:31:46] Speaker 01:
If you want to get to 102, 103, different story.

[00:31:50] Speaker 01:
Thank you, Your Honors.

[00:31:51] Speaker 04:
Appreciate it.

[00:31:52] Speaker 01:
Appreciate the indulgence of the time.