[00:01:14] Speaker 04:
You're reserving four minutes?

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

[00:01:17] Speaker 04:
Again, I'll let you know when you run up on it.

[00:01:25] Speaker 01:
May it please the court.

[00:01:27] Speaker 01:
This case concerns the broadest reasonable interpretation of Claim 2 of the 086 patents.

[00:01:33] Speaker 03:
Speak up, sir.

[00:01:35] Speaker 01:
The other four claims of the 086 patent were held invalid by the board below, and they're not being challenged here on appeal.

[00:01:43] Speaker 01:
Dartmouth originally filed a cross appeal and then later dismissed that cross appeal.

[00:01:49] Speaker 01:
And so that ruling that the other four claims are anticipated is final and uncontestable.

[00:01:56] Speaker 01:
Claim two of the 086 patent is a dependent claim, which depends from claim one.

[00:02:01] Speaker 01:
Claim one is drawn to a pharmaceutical composition comprising nicotinamide riboside, which the parties refer to as NR, in admixture with a carrier, wherein the composition is formulated for oral administration.

[00:02:15] Speaker 04:
Dartmouth says that under your preferred construction of isolated, if one milks a cow or if one skims fat off whole milk, that one has isolated NR.

[00:02:30] Speaker 04:
Is that a fair characterization of your proposed construction?

[00:02:32] Speaker 01:
Yes, Your Honor.

[00:02:33] Speaker 01:
We do believe that skim milk falls within the scope of Claim 2, that it's covered by it.

[00:02:39] Speaker 04:
And milk coming out of a cow has been isolated.

[00:02:43] Speaker 01:
It certainly could be, Your Honor.

[00:02:45] Speaker 01:
We are not pressing that argument on appeal, and I don't think that the court needs to get there in order to resolve this issue.

[00:02:52] Speaker 01:
But I do think I'd like to make two points.

[00:02:54] Speaker 04:
It's not a question of needing to get there.

[00:02:56] Speaker 04:
If we're there, I think that's problematic.

[00:03:03] Speaker 01:
Your Honor, let me make two responses to that.

[00:03:05] Speaker 01:
The first is that, as I mentioned, it is now uncontestable that the administration of skim milk or the administration of buttermilk anticipates claim one.

[00:03:16] Speaker 01:
So we know that claim one

[00:03:19] Speaker 01:
reads on or is covered by, anticipated by skim milk and buttermilk.

[00:03:24] Speaker 00:
It all comes down to the meaning of isolated.

[00:03:27] Speaker 00:
And as I understand it, you're relying on the breadth of a broad definition that says something to the effect of as used herein in this specification, the word isolated means, and it's broad.

[00:03:42] Speaker 00:
And that's what you're relying on.

[00:03:44] Speaker 00:
And you think we should not consider anything else in this specification

[00:03:49] Speaker 00:
including the repeated examples, which say that the NR can be isolated from milk.

[00:03:56] Speaker 01:
Well, I don't think that there's anything in the specification that is inconsistent with our position.

[00:04:03] Speaker 01:
But first, let me just state that claim two, what claim two is doing is it is adding a source limitation to claim one.

[00:04:10] Speaker 01:
So the specification says that there are three sources.

[00:04:13] Speaker 00:
That's your interpretation of it, right?

[00:04:14] Speaker 00:
Yes.

[00:04:15] Speaker 00:
You're saying it can come from a natural source, a synthetic source,

[00:04:19] Speaker 00:
But why shouldn't an isolated be given some meaning?

[00:04:23] Speaker 00:
I think your argument for why it should be given a meaning that's inconsistent with this plain and ordinary meaning is that you think the patent owner here chose to be its own lexicographer, right?

[00:04:33] Speaker 01:
Yes, Your Honor.

[00:04:33] Speaker 01:
And the way that it chose to define isolated is not strange, given the time in which this patent was drafted and prosecuted.

[00:04:41] Speaker 01:
This is the pre-Maria days, where the word isolated was frequently inserted into claims in order to address potential 101 rejections.

[00:04:51] Speaker 01:
And so you would isolate DNA by cutting the DNA out of a cell.

[00:04:55] Speaker 01:
But that word was not intended to, it was really just, that's the slightest hand of man, so that the claim would get over a 101 problem.

[00:05:04] Speaker 00:
But it wasn't intended, certainly, certainly- We shouldn't be thinking about that though, right?

[00:05:09] Speaker 00:
We should just be focusing on the intrinsic evidence here.

[00:05:13] Speaker 01:
Yes, Your Honor, but I think it explains why, I think it explains why isolated was defined the way it was, and why it was defined as broadly as it was, because the applicant,

[00:05:22] Speaker 01:
Intended for that word to be extremely broad really as broad as possible to exclude only okay, but setting that aside your Interpretation what they you think they were thinking.

[00:05:34] Speaker 00:
Why don't you really just focus on the intrinsic evidence?

[00:05:37] Speaker 01:
Okay, so the We think if we begin with the claim so the specification Clearly states that there are three sources of Nr.

[00:05:45] Speaker 01:
That's undisputed Dartmouth agrees with that and the specification says that there are three sources there are natural sources and

[00:05:51] Speaker 01:
there are synthetic sources, and then there's chemical synthesis.

[00:05:55] Speaker 01:
And so what Claim 2 is doing, it is narrowing the scope of Claim 1 to exclude chemical synthesis.

[00:06:01] Speaker 01:
And it is saying, while Claim 1 can include NR that was made with chemical synthesis, Claim 2 cannot.

[00:06:08] Speaker 01:
It can only have NR that is drawn from a natural or synthetic source.

[00:06:13] Speaker 00:
Why is the board wrong in its conclusion

[00:06:18] Speaker 00:
Reading the specification as a whole, a person of ordinary scale in New York would not interpret isolated to be as broad as you're arguing.

[00:06:29] Speaker 01:
Because there is no support for that finding.

[00:06:32] Speaker 01:
There's no expert testimony to support that argument.

[00:06:36] Speaker 01:
Dartmouth's expert did comment on claim construction in his declaration, but he didn't comment on claim two.

[00:06:41] Speaker 01:
And he certainly didn't disagree with Elysium's proposed construction or offer any expert testimony to support the board's construction.

[00:06:48] Speaker 00:
There's a couple places, as I mentioned before, in the specification that say the NR is isolated from milk.

[00:06:55] Speaker 00:
Why doesn't that support the proposition that whatever isolated means, it surely doesn't mean just having milk?

[00:07:02] Speaker 01:
Well, I think what the specification says is that the milk can be a source of NR.

[00:07:08] Speaker 01:
And that is exactly what the prior art disclosed.

[00:07:15] Speaker 00:
So you don't think, I mean, for example, in column 26, lines 32 through 34, it says the NR is isolated from deproteinized whey fraction of cow's milk.

[00:07:28] Speaker 00:
And there's other places, too, and they use the word isolated.

[00:07:32] Speaker 00:
They're not just saying, there are places, I guess, where the patent specification says that the NR could be, the source of the NR could be milk.

[00:07:40] Speaker 00:
But what I just read to you uses the word isolated.

[00:07:43] Speaker 01:
Yes, your honor.

[00:07:44] Speaker 01:
And so our response to that is that is exactly what is going on in the prior art.

[00:07:49] Speaker 01:
Both pieces of prior art involved processed milk products, skim milk and buttermilk, where whole milk is being processed to create a new product that is different from the whole milk and where the NR has been isolated.

[00:08:06] Speaker 00:
I understand.

[00:08:06] Speaker 00:
I understand what the prior art teaches.

[00:08:09] Speaker 00:
I'm asking you why the specification with its example of saying that

[00:08:13] Speaker 00:
and are as isolated from milk, why that doesn't support the board's conclusion that it can't just be skim milk or butter milk, as was the case in one of the references.

[00:08:28] Speaker 01:
OK.

[00:08:28] Speaker 01:
I have two responses to that.

[00:08:29] Speaker 01:
The first is that the statement that you just referred to is not inconsistent with the broad definition.

[00:08:35] Speaker 01:
It falls well within the scope of what isolated means as defined in the specification.

[00:08:41] Speaker 01:
It may be more isolated than what is

[00:08:43] Speaker 01:
defined in the specification, but it's not inconsistent with it.

[00:08:46] Speaker 01:
The second thing, and this perhaps is even more important, there's nothing in the specification, certainly nothing in that statement, that gets you to a 25% purity requirement, which is what the board held.

[00:08:57] Speaker 00:
Right.

[00:08:57] Speaker 00:
And so there, the board would say, and the board held, I guess, that a person boarding an area scale in the yard would not limit the language in column 9, lines 10 through 12

[00:09:13] Speaker 01:
to a polypeptide.

[00:09:27] Speaker 01:
Here's what isolated molecule means.

[00:09:29] Speaker 01:
And it defines it broadly to include things like DNA and cDNA and polypeptides.

[00:09:34] Speaker 01:
And then in the next sentence, it says, when the isolated molecule is a polypeptide.

[00:09:41] Speaker 01:
And if that sentence is to make sense, it must mean only when the isolated molecule is a polypeptide.

[00:09:47] Speaker 01:
Otherwise, those words wouldn't appear in the sentence.

[00:09:51] Speaker 01:
And so they've taken something that by its plain terms applies only to polypeptides and said that it applies to all isolated molecules.

[00:10:00] Speaker 00:
It applies to... So the patent justification talks about NRK as well as NR... NRK is not plain, right?

[00:10:12] Speaker 00:
Correct.

[00:10:14] Speaker 00:
Is NRK something that can be made as a pharmaceutical composition?

[00:10:19] Speaker 01:
I don't know the answer to that.

[00:10:20] Speaker 01:
The specifications.

[00:10:22] Speaker 00:
How do you tell me I don't have this kind of technical background?

[00:10:26] Speaker 00:
Tell me what happens to the NR and how it becomes NRK.

[00:10:32] Speaker 01:
Well, so the NRK, the discussion of NRK and the specification really, I think, is talking about a different invention altogether than the one that is claimed in the patent.

[00:10:43] Speaker 01:
As I understand it, the enzyme is metabolizing nicotinamide riboside

[00:10:48] Speaker 01:
along a pathway in order to increase NAD+.

[00:10:59] Speaker 01:
So I guess just to reiterate a couple of the arguments.

[00:11:05] Speaker 01:
We think that there's really no way to square the grammatical language of column 9, the definition, to impose a 25% purity requirement on any isolated molecule.

[00:11:18] Speaker 01:
It's just not what the specification says.

[00:11:21] Speaker 01:
And it certainly was not putting the public on notice that Claim 2 carries with it a 25% purity requirement.

[00:11:27] Speaker 01:
Notably, Dartmouth itself, the patent owner, the party that filed this patent application, prosecuted it, and now owns it,

[00:11:33] Speaker 04:
The PTAB in its anticipation analysis concluded that it didn't even need the 25% purity requirement to find not anticipated because of Goldberg.

[00:11:43] Speaker 01:
Correct, Your Honor.

[00:11:44] Speaker 01:
So what the board did in sort of its fallback position is it said, OK, if there's no purity requirement, then the NR must be isolated from all of the components of the natural source, all of the fats, all of the carbohydrates, all of the salts.

[00:12:03] Speaker 01:
So they said, here's our second possible claim construction in just a two paragraph section of its opinion.

[00:12:09] Speaker 01:
And so that construction is wrong as well, because there's nothing in the specification that says that the NR has to be 100% isolated from its source.

[00:12:18] Speaker 01:
Even in the fractionated whey protein example that was referenced earlier, it's not completely separated from the NR.

[00:12:27] Speaker 04:
But that leads me to- You're in your response line.

[00:12:30] Speaker 04:
Please keep going.

[00:12:31] Speaker 04:
It's up to you.

[00:12:33] Speaker 01:
OK, I'll reserve my time.

[00:12:34] Speaker 01:
Thank you.

[00:12:50] Speaker 02:
May it please the Court.

[00:12:52] Speaker 02:
Your Honors, much of the discussion today, this morning, has been about the board's construction.

[00:12:58] Speaker 02:
But what I'd like to start with is probably the most simple path to affirming the board's decision.

[00:13:03] Speaker 04:
Let me ask you a question.

[00:13:04] Speaker 04:
On page 20 of the blue brief, Elysium says you, quote, never even attempted to submit evidence to support the PTABS construction.

[00:13:14] Speaker 04:
And separately, you never, quote, never opined that the PTABS construction was correct or that Elysium's profit construction was incorrect.

[00:13:24] Speaker 04:
We asked about expert.

[00:13:26] Speaker 04:
Is it true?

[00:13:27] Speaker 04:
Is what they're saying true?

[00:13:28] Speaker 04:
Did you make that argument, and where is it in the record?

[00:13:30] Speaker 02:
What they're saying is not true.

[00:13:32] Speaker 02:
We certainly have plenty of evidence to support the PTABS construction.

[00:13:35] Speaker 02:
There is no expert testimony on really either side that talks about this 25% purity limitation.

[00:13:42] Speaker 02:
What we have is expert testimony from Elysium, where they just quote the definition and apply it.

[00:13:48] Speaker 02:
They take this broad grammatical reading.

[00:13:50] Speaker 00:
But the point is, the question is, did you present any argument in support of the board's construction?

[00:13:56] Speaker 02:
Absolutely, yes, we did so they in support of the board's construction first We have this notion that it isn't possible to read this definition the way that Elysium was in the record is what's okay sure so the definition in a vacuum is that column nine of the path and

[00:14:25] Speaker 02:
Isolated means a molecule separated or substantially free from at least some of the other components of the naturally occurring organism What line are you on sorry line five six and seven okay?

[00:14:39] Speaker 02:
And so what Elysium wants to do is take that definition read it in a vacuum and say okay well if we pull a single molecule out of the naturally occurring organism the cow and

[00:14:52] Speaker 02:
We have isolated an R. How do we know that that's unreasonable?

[00:14:58] Speaker 02:
How do we know that that can't make sense?

[00:15:00] Speaker 02:
Well, I would like to turn you to column 27 of the patent.

[00:15:10] Speaker 02:
Actually, the last line of column 26, the last word, natural,

[00:15:18] Speaker 02:
Bridging over to column 27, this is the portion of the specification that identifies what the natural sources of NR are.

[00:15:28] Speaker 02:
And the natural sources of NR from which you can isolate something is a list of foods.

[00:15:35] Speaker 02:
This is a list of food items from which you can isolate NR.

[00:15:39] Speaker 02:
And that list says cow's milk, serum, meats, eggs, fruits, and cereals.

[00:15:46] Speaker 02:
It is impossible to read a claim that calls for isolated NR, NR that's isolated from a natural source, on the source itself, from which you isolate the NR.

[00:15:59] Speaker 02:
There's the long line of cases, SIMED, that says, well, they want you to read it onto the cow.

[00:16:07] Speaker 02:
Well, it's interesting, your honor, because if you look at their reply brief, we made this argument that there's no way you can read this on milk that comes from a cow.

[00:16:15] Speaker 02:
And their response in their reply brief is no, no, no, we're not talking about whole cow's milk.

[00:16:20] Speaker 02:
We're talking about processed milk here.

[00:16:22] Speaker 02:
They're trying to draw a line between cow's milk and processed milk.

[00:16:26] Speaker 02:
Why?

[00:16:26] Speaker 02:
Because they say the prior art is skim milk and buttermilk.

[00:16:31] Speaker 02:
That's processed milk.

[00:16:32] Speaker 02:
But today,

[00:16:33] Speaker 02:
You heard a response where they were waffling a little bit about whether or not isolated NR would cover actual whole milk coming from a cow.

[00:16:43] Speaker 02:
I don't think that waffle, it was conceded.

[00:16:46] Speaker 02:
Okay.

[00:16:47] Speaker 02:
And so now where they want to draw the line is between processed and unprocessed milk.

[00:16:52] Speaker 02:
But there's no support in the specification for that.

[00:16:54] Speaker 02:
There's several

[00:16:55] Speaker 02:
portions of the specification that talk about milk being a source of NR.

[00:16:58] Speaker 02:
It never says unprocessed whole milk.

[00:17:01] Speaker 02:
And then if you look at this list of sources, these foods, it shows that this line that they're trying to draw between processed and unprocessed is just silly.

[00:17:11] Speaker 02:
Presumably under their logic.

[00:17:13] Speaker 00:
He might have even admitted today that in his view unprocessed milk would satisfy this claim.

[00:17:20] Speaker 00:
I believe that he admitted that.

[00:17:22] Speaker 00:
I think he did say that today, but in their reply brief... But even setting that aside, as I understand your argument, is that no matter what you think the claim construction is, it can include milk.

[00:17:34] Speaker 02:
No matter what the claim construction is, it can't include milk, certainly, but it also can include skim milk or buttermilk.

[00:17:41] Speaker 02:
Right?

[00:17:42] Speaker 02:
Because they're trying to draw this line between whole milk and skim milk or buttermilk.

[00:17:46] Speaker 02:
But there isn't a line in this list of natural sources between processed and unprocessed foods.

[00:17:52] Speaker 02:
Under their proposed line drawing, if you pick a banana off a tree, you've got yourself a natural source of NR, but you peel that banana, and it's no longer a natural source.

[00:18:04] Speaker 02:
One of the examples is eggs.

[00:18:06] Speaker 02:
Whole eggs from a chicken.

[00:18:07] Speaker 02:
Well, you crack those eggs, you remove the shell, and all of a sudden that's processed and it's not a source.

[00:18:14] Speaker 02:
Meats is another one.

[00:18:15] Speaker 02:
Presumably, under their construction, any sort of butchering of the meat... You're beating this horse to death.

[00:18:22] Speaker 02:
Okay.

[00:18:23] Speaker 02:
But the reason that I'm beating... Whether it's skinned or not.

[00:18:28] Speaker 02:
Right.

[00:18:28] Speaker 02:
But the reason I'm beating this horse to death is that, and this goes to the point that

[00:18:33] Speaker 02:
Your Honor's made about what the appellants have called the alternate construction.

[00:18:39] Speaker 02:
And what I think the appellants have kind of mischaracterized this alternate construction, because what the board said was, OK, if you don't like the 25% limitation,

[00:18:51] Speaker 02:
We still have no anticipation.

[00:18:53] Speaker 02:
Why is that?

[00:18:54] Speaker 02:
What you heard appellant say was, well, there's a portion in the specification that says, when you're going to isolate milk, you got to get rid of all these other components.

[00:19:02] Speaker 02:
So that means it has to have a high purity level.

[00:19:04] Speaker 02:
But that's not what the board said in its alternate construction.

[00:19:08] Speaker 02:
What the board said, and I'm quoting from appendix page 27 and 38, they say,

[00:19:19] Speaker 02:
regardless of whether the claims require a minimum percentage of NR.

[00:19:24] Speaker 02:
We find that the NR present in skim milk is not isolated because significant amounts of other components remain after the fat is removed.

[00:19:34] Speaker 02:
So what the board is saying is that if you don't like the 25%, we know that there has to be something more than an insignificant amount.

[00:19:45] Speaker 02:
And there's no evidence that the prior art has anything more than an insignificant amount.

[00:19:52] Speaker 02:
How do we know that?

[00:19:54] Speaker 02:
Well, Dartmouth submitted evidence in its brief at pages 34 and 37 that whole milk has 0.0001097% NR.

[00:20:09] Speaker 02:
And skim milk has 0.0001143% NR.

[00:20:15] Speaker 02:
And those numbers are not challenged by appellants in this case.

[00:20:22] Speaker 02:
And so when we look at the definition of isolated in column nine of the patent,

[00:20:36] Speaker 02:
It has the definitional phrase, but immediately after that, it talks about the polypeptides, and it lists a number of purities, where 25% is the lowest purity for the polypeptides.

[00:20:49] Speaker 02:
So that follows the definitional phrase.

[00:20:50] Speaker 02:
So we know at the very least that an isolated molecule has to have some minimum level of purity.

[00:20:58] Speaker 02:
A reader is going to understand that from the specification.

[00:21:01] Speaker 02:
So what is that minimum level of purity for NR in this case?

[00:21:05] Speaker 02:
Appellants would say that for the polypeptides, that minimum level is 25%.

[00:21:10] Speaker 02:
But for every other molecule, it's completely de minimis.

[00:21:15] Speaker 02:
It would cover the tiny amounts in milk.

[00:21:19] Speaker 02:
And there's no way that you can read this claim on milk.

[00:21:23] Speaker 02:
We know that can't be possible.

[00:21:26] Speaker 02:
So we know that this broad grammatical reading of this single sentence in column 9 can't be right.

[00:21:35] Speaker 02:
We know it can't be right.

[00:21:37] Speaker 02:
So the question is, is where do you set that purity level?

[00:21:41] Speaker 02:
And what the board found was, well, we think it's 25%.

[00:21:45] Speaker 02:
We think there's enough information in the specification to put it at 25%.

[00:21:49] Speaker 02:
But even if there isn't, we know it's got to be more than de minimis.

[00:21:53] Speaker 02:
It's got to be more have some significance to it and there is no evidence in the present any expert Testimony support that that oppose are reading this specification We think that it has to be at least 25% At least 25 or whatever not the 25% but there is evidence in truth the intrinsic evidence shows that

[00:22:14] Speaker 00:
I understand.

[00:22:15] Speaker 00:
Maybe you can say, I don't think we needed it.

[00:22:18] Speaker 00:
Yeah, certainly, I don't think we needed it.

[00:22:20] Speaker 02:
But there's certainly evidence in the record in terms of the percentages of NR that are actually in milk.

[00:22:26] Speaker 02:
And these are the sources of milk.

[00:22:28] Speaker 00:
Don't you think that it's kind of weird for the court to, I mean, it is true.

[00:22:33] Speaker 00:
They have an argument that that reference to 25%, 50%, and all those other percentages does say it's limited to a polypeptide, right?

[00:22:43] Speaker 02:
Well, that sentence surely does talk about the polypeptides.

[00:22:47] Speaker 00:
It does.

[00:22:48] Speaker 00:
With respect to polypeptides, isolation requires this level of purification.

[00:22:54] Speaker 02:
Sure.

[00:22:54] Speaker 02:
And so the question is, how can you anchor the NR to that 25% number if you're going to support the 25% number?

[00:23:00] Speaker 00:
Especially when there's disclosure of NRK in the specification.

[00:23:03] Speaker 02:
Sure.

[00:23:03] Speaker 02:
And to answer your question that you asked of Appellant's Council, your Honor, can NRK be a molecule that's isolated for therapeutic administration?

[00:23:12] Speaker 02:
The answer to that question is yes.

[00:23:14] Speaker 02:
That's in column

[00:23:16] Speaker 02:
19 of the patent and This gets to the issue of of and I think part of the reason why you were asking that question your honor is

[00:23:25] Speaker 02:
is that what do we know about the polypeptides?

[00:23:28] Speaker 02:
This talks about therapeutic administration of the NRK polypeptides can be purified.

[00:23:34] Speaker 02:
And then it goes on to talk about the isolation techniques that you use for the polypeptides.

[00:23:40] Speaker 02:
And those are centrifuging.

[00:23:42] Speaker 02:
And you're ripping out the cellular debris.

[00:23:45] Speaker 02:
And then you go to the fractionation techniques that are identified for isolating NR.

[00:23:51] Speaker 00:
And those are in- Does this discussion help your claim construction?

[00:23:54] Speaker 02:
I think so, yes.

[00:23:55] Speaker 00:
Because the separation... I read all of this.

[00:23:58] Speaker 02:
Okay, sure.

[00:23:59] Speaker 02:
So the techniques for isolating NRK, the polypeptide, are the same as the techniques that are used for isolating NR.

[00:24:07] Speaker 02:
These are laboratory techniques.

[00:24:09] Speaker 02:
for ripping out a small molecule from a bunch of other small molecules done at a molecular and subcellular level.

[00:24:15] Speaker 02:
It's talking about ripping out these small molecules from cellular debris.

[00:24:20] Speaker 02:
It's not skimming the fat off milk.

[00:24:22] Speaker 03:
If we conclude that the PTAB's claim construction is not supportable because they incorporated the 25% from an inappropriate part of the written description, can we still

[00:24:39] Speaker 03:
find that they were correct on their anticipation ruling, and if so, how?

[00:24:45] Speaker 02:
Absolutely.

[00:24:46] Speaker 02:
Two different ways.

[00:24:47] Speaker 02:
One is the notion that regardless of what the definition is, regardless of the claim construction,

[00:24:55] Speaker 02:
That's this claim to cannot read on the prior art as a matter of law under Simon and all of the cases that say that when the patent specification makes it clear that a particular feature isn't covered by the invention, then it is improper to construe claims to cover that feature.

[00:25:12] Speaker 02:
And what we're doing or what the pounds are trying to do in this case is read

[00:25:16] Speaker 02:
the claims on the sources from which you isolate NR.

[00:25:20] Speaker 02:
The second way that you could affirm the board's decision is through this alternate construction.

[00:25:25] Speaker 02:
The alternate construction is if we don't like the 25 percent.

[00:25:30] Speaker 02:
We know that number.

[00:25:31] Speaker 03:
Do you like the 25%?

[00:25:32] Speaker 03:
What's that?

[00:25:33] Speaker 03:
Do you like the 25%?

[00:25:34] Speaker 02:
I think the 25% is a reasonable construction in light of the specification.

[00:25:39] Speaker 02:
I think the broadest construction that we're hearing from appellants is unreasonable and not supportable.

[00:25:44] Speaker 02:
Let's assume we don't like the 25%.

[00:25:47] Speaker 02:
Go with your second point.

[00:25:49] Speaker 02:
The second point is the board's alternate construction.

[00:25:53] Speaker 02:
And that is we know there has to be some minimum level of purity.

[00:25:56] Speaker 02:
We don't know what that number is, but we do know

[00:25:59] Speaker 02:
It has to be more than insignificant.

[00:26:02] Speaker 02:
And we don't have an exact number for that, but we don't know how much NR is in the prior art.

[00:26:07] Speaker 02:
What we do know is that in the prior art, these are milk sources.

[00:26:12] Speaker 02:
These are the sources from which you isolate.

[00:26:15] Speaker 02:
And so there's no evidence that there's anything more than de minimis amounts of NR in the prior art.

[00:26:22] Speaker 03:
If we don't like the claim construction, don't we have to send it back to the PTAB and say, your claim construction doesn't work, rethink it?

[00:26:33] Speaker 03:
Or can we just go ahead and adopt their anticipation ruling?

[00:26:39] Speaker 02:
You can adopt their anticipation ruling for those two reasons that I just said.

[00:26:43] Speaker 02:
You don't need a construction.

[00:26:45] Speaker 02:
of isolated in order to affirm the board's decision.

[00:26:49] Speaker 02:
Because regardless of the construction, there's no way to read that claim on buttermilk and skim milk.

[00:26:55] Speaker 02:
OK.

[00:26:56] Speaker 02:
That's the Goldberg problem.

[00:27:00] Speaker 02:
Thank you, yours.

[00:27:08] Speaker 01:
I'd like to begin by addressing this question of whether, regardless of the claim construction, the claim is anticipated.

[00:27:14] Speaker 01:
That is a disavowal argument.

[00:27:16] Speaker 01:
There is no disavowal here.

[00:27:18] Speaker 01:
The rules for disavowal are strict, and they are not met here.

[00:27:21] Speaker 01:
Nowhere in the specification does the applicant say, our pharmaceutical composition is not skim milk, is not buttermilk.

[00:27:33] Speaker 01:
They simply talk about milk as being the source of NR.

[00:27:37] Speaker 01:
And that is exactly what is in the prior art.

[00:27:40] Speaker 01:
The other thing is that they have already admitted

[00:27:43] Speaker 01:
It is incontestable that the prior art, buttermilk and skim milk, infringe or anticipate all of the other claims of this patent.

[00:27:53] Speaker 01:
And there is no reason to think that claim two alone should survive because of the few references to milk in the specification.

[00:28:02] Speaker 01:
With respect to the alternate construction, there needs to be a claim construction before any tribunal can address the anticipation question.

[00:28:11] Speaker 01:
Dartmouth wants to say, let's not do claim construction.

[00:28:14] Speaker 01:
Let's just get to no anticipation.

[00:28:16] Speaker 00:
It's as if they have a negative limitation, right?

[00:28:20] Speaker 00:
In a sense, whatever this claim construction is, whether it's the broader construction of isolated, you know, the definition in the specification,

[00:28:30] Speaker 00:
Specification also lets you know that it's not milk.

[00:28:34] Speaker 00:
So it would be isolated, but not the natural source itself.

[00:28:40] Speaker 01:
But the specification never says, our pharmaceutical composition comprising NR isolated from a natural source, that is not milk.

[00:28:46] Speaker 01:
The specification barely talks about pharmaceutical compositions.

[00:28:50] Speaker 00:
But it's a word isolated, we should be focusing on.

[00:28:53] Speaker 01:
OK, and so if we can just talk about the CLEEM 2627 NR detection method for a minute.

[00:29:01] Speaker 01:
And so that is a laboratory test to determine whether or not a potential source of NR, your fruit or your meat, has or does not have NR.

[00:29:11] Speaker 01:
And the specification says the first thing you can do is prepare a sample.

[00:29:16] Speaker 01:
an isolated extract of the source to see whether or not it has NR or doesn't have NR.

[00:29:21] Speaker 01:
So you prepare your sample, you test it, it has NR or it doesn't have NR.

[00:29:27] Speaker 01:
If it has NR, you can further fractionate it.

[00:29:29] Speaker 01:
If it doesn't have NR, the purity of NR is zero.

[00:29:33] Speaker 01:
There's no connection between the NR detection method description and a 25% purity limitation.

[00:29:41] Speaker 01:
And their argument that we need to look to column 26 and 27 to impose this stringent requirement on isolated is flatly inconsistent with the express definition of the word.

[00:29:54] Speaker 01:
I mean, the public and people out there in marketplace should be able to read a specification and see they have expressly defined this.

[00:30:01] Speaker 01:
They use the word an isolate molecule means x.

[00:30:05] Speaker 01:
And they should be taken at their word.

[00:30:07] Speaker 01:
And we shouldn't have the claims dramatically rewritten, dramatically narrowed in an IPR so that they can avoid the prior art.

[00:30:14] Speaker 03:
Your view is they've milked that for all it's worth.

[00:30:19] Speaker 01:
Excuse me?

[00:30:22] Speaker 01:
Skin milk, Your Honor.

[00:30:23] Speaker 01:
Skin milk and buttermilk.

[00:30:36] Speaker 01:
I also say that there is a fundamental difference between a purity requirement and a source requirement.

[00:30:43] Speaker 01:
And Dartmouth wants to begin with the assumption that there must be a purity requirement in this claim.

[00:30:48] Speaker 01:
Why?

[00:30:49] Speaker 01:
The claim adds a source limitation.

[00:30:51] Speaker 01:
If the applicants wanted a purity limitation, they could have easily said, wherein the NRs constitutes at least 25% of the product.

[00:31:00] Speaker 01:
And they elected not to do that.

[00:31:01] Speaker 01:
They've enjoyed these broad claims for years.

[00:31:05] Speaker 01:
Thank you, Your Honor.

[00:31:07] Speaker 04:
I would commend counsel.

[00:31:09] Speaker 04:
I don't know if you're familiar, but I would commend you both to the actual history of Dr. Goldberger.

[00:31:14] Speaker 04:
He's a fascinating character.

[00:31:16] Speaker 01:
Thank you.