[00:00:05] Speaker 01:
Good morning, everyone.

[00:00:07] Speaker 01:
The first argued case this morning is number 15-1218, Hemopet against Hills Pet Nutrition.

[00:00:16] Speaker 01:
Ms.

[00:00:16] Speaker 01:
Heemlouis.

[00:00:20] Speaker 02:
Good morning, Your Honors.

[00:00:21] Speaker 02:
May I proceed?

[00:00:22] Speaker 02:
Please.

[00:00:23] Speaker 02:
My name is Frances Lewis, and today I will be arguing for the appellant, Hemopet.

[00:00:28] Speaker 02:
The Hemopet patent passed the Supreme Court's two-part test for identifying patent-eligible subject matter.

[00:00:35] Speaker 02:
They are not directed to abstract concepts, laws of nature, or natural phenomena.

[00:00:40] Speaker 02:
And the claims teach a physical process for making and formulating pet nutritional products based on an analysis of genomic data.

[00:00:49] Speaker 04:
Can I ask just about that physical process point?

[00:00:53] Speaker 04:
I thought that some of the claims end with language about making a product, but a bunch of them don't, just formulating a diet, which is

[00:01:05] Speaker 04:
you know, writing down something maybe.

[00:01:08] Speaker 04:
Is that, there is some difference, is that right or not?

[00:01:10] Speaker 02:
You are correct that there are different limitations at the end of the claim, some end in formulating, some end in preparing.

[00:01:16] Speaker 02:
The district court construed the preparing term to mean making the actual nutritional composition, but I would disagree that the characterization of formulating is simply writing down the information.

[00:01:26] Speaker 02:
The district court construed those terms to mean actually designing and developing, depending on the claim, the nutritional diet or diet product.

[00:01:35] Speaker 02:
And those terms are construed to mean a particular nutrient or caloric composition.

[00:01:40] Speaker 02:
So even the claims that end with the term of a formulating limitation are directed toward the physical process.

[00:01:46] Speaker 02:
And certainly, the analysis that's part of the claim, I think, also is directed to part of the physical process, even though it is computer-driven.

[00:01:53] Speaker 02:
But today, I'd actually like to focus my argument on three points.

[00:01:56] Speaker 02:
I want to discuss the seminal case of diamond versus deer and discuss how the hemopet patents do resemble the industrial process deemed eligible in deer.

[00:02:05] Speaker 02:
I want to address this court's holding in class and immunotherapies and why the hemopet patents resemble the claims that were held eligible in that opinion, which is still good law.

[00:02:15] Speaker 02:
And finally, if there's time at the end, I want to address some of the more recent life sciences opinions in the area of 101, such as Mayo, Inri Braka, and Ariosa, to show how even though those claims were ineligible, the differences between the hemopet patents and the patents in those cases counsel the finding of eligibility here.

[00:02:33] Speaker 01:
Okay, proceed.

[00:02:35] Speaker 02:
With respect to Diamond vs. Deere, this is one of the Supreme Court's seminal holdings of eligibility in a patent case.

[00:02:42] Speaker 02:
It's an older opinion, but in the last four Supreme Court opinions on Section 101 from this decade, the Supreme Court has gone out of its way to analyze and affirm the holding in Diamond vs. Deere.

[00:02:54] Speaker 02:
In Deere, we had a patent that took the Arrhenius equation, which had been used previously in the process of tearing rubber,

[00:03:01] Speaker 02:
And the patents claimed an innovative way of repeatedly applying that equation throughout the process of curing rubber to figure out the appropriate time and temperature, excuse me, the appropriate time based on the temperature for which to open the press.

[00:03:16] Speaker 02:
But the press, in that case, these were not innovative tools.

[00:03:20] Speaker 02:
You were using the same instrumentation that had been used before.

[00:03:23] Speaker 02:
You were using the same technology that had been used before.

[00:03:26] Speaker 04:
But I didn't dare say, and maybe Alice picked up on this,

[00:03:30] Speaker 04:
the patentee or applicant, I guess, in Deere said, our key advance is the constant monitoring of the temperature.

[00:03:42] Speaker 02:
Yes, that is correct.

[00:03:43] Speaker 04:
But what I would note is that... That's a new physical thing, right?

[00:03:46] Speaker 02:
It actually was not a new physical thing.

[00:03:48] Speaker 02:
The existence of thermocouples had been around, and it's something that Justice Stevens pointed out.

[00:03:52] Speaker 04:
No, no, not a measuring device that wasn't new, but Deere itself describes

[00:03:59] Speaker 04:
the applicant as characterizing its advance as using this thing to measure the temperature inside the press constantly?

[00:04:11] Speaker 02:
That is correct, but I would qualify that by saying that it wasn't just the measuring constantly, it was the application of the Arrhenius equation to constantly re-evaluate the temperature in order to determine the optimal time to open it.

[00:04:25] Speaker 02:
without the computerized technology of the Arrhenius equation and the ability to use through a computer the repeated calculations, there would have been not much difference between what had been done before with the measurement of the temperature in the press and the time at which to open it using the Arrhenius equation.

[00:04:41] Speaker 02:
So I agree with that characterization, but I do think part of the innovation in that case was the method in which they applied the computerized technology and specifically the Arrhenius equation in order to determine when to open the press.

[00:04:53] Speaker 02:
And if you look at the hemopet patents, for example, they too claim a physical process.

[00:04:57] Speaker 02:
It's a little bit broader in that it's not just limited to industrial applications.

[00:05:01] Speaker 02:
It can be a smaller sample size, for example, of mixing ingredients in a smaller situation.

[00:05:07] Speaker 02:
But it's the same idea that you're looking at coming up with new inputs to a calculation.

[00:05:11] Speaker 02:
In our case, if you look at claims.

[00:05:13] Speaker 00:
That's not anything more than an idea, is it?

[00:05:17] Speaker 00:
That's what hasn't been implemented, at least

[00:05:20] Speaker 00:
the patent doesn't give any examples of the implementation of the idea, right?

[00:05:25] Speaker 02:
I would agree that it doesn't give a specific example of the implementation and specification, but I would disagree that the claims are somehow limited to an idea.

[00:05:33] Speaker 02:
The claims themselves are the scope of the language of the patent, and they're what we turn to first to understand what the claims cover.

[00:05:40] Speaker 02:
And in the claims, they outline the specific inputs that are going to be used to actually apply the ideas

[00:05:48] Speaker 02:
that are part of the invention.

[00:05:49] Speaker 02:
You look at claims one and two of the 343, the first limitations describe the specific data inputs that you need.

[00:05:56] Speaker 02:
You're going to have to have genomic data relating to a physiological condition from bodily tissue samples or from bodily fluid samples.

[00:06:04] Speaker 02:
They then describe the process for having data relating to the effect of nutrition on the genomic data.

[00:06:11] Speaker 02:
And then through that process, and I do think that the figures in the patent outline the analysis

[00:06:16] Speaker 02:
you use that information to analyze the genomic data and then based on that combination, you've been able to determine in a way that had not been done before at the time, which ingredients are likely to have an influence on the genomic data of an animal.

[00:06:33] Speaker 02:
And in conclusion from that, patents don't end there, you do something with that data.

[00:06:38] Speaker 02:
You either formulate or prepare a nutritional diet or diet product, which again the court construed is actually designing and developing

[00:06:45] Speaker 02:
the particular nutrient or caloric composition.

[00:06:48] Speaker 02:
And that's what these claim languages cover.

[00:06:51] Speaker 02:
And this is similar to the process in deer.

[00:06:53] Speaker 02:
The patent in deer, for example.

[00:06:55] Speaker 04:
Can you just clarify something, which is what I asked you at the beginning, and maybe it's the usage that I'm stuck on.

[00:07:02] Speaker 04:
So formulating a diet or formulating a diet composition or something seems to me to at least be ambiguous between deciding

[00:07:15] Speaker 04:
what foods to give and constructing the food item.

[00:07:24] Speaker 04:
Which is it?

[00:07:25] Speaker 04:
And what did the district court construe the claim language to mean actual, the physical creation of something the dog could put in its mouth?

[00:07:34] Speaker 02:
Yes, that's our understanding of the claim construction order.

[00:07:37] Speaker 02:
Part of what Hills had proposed as part of the construction of the phrase, formulating a nutritional diet or diet product,

[00:07:42] Speaker 02:
was the idea of simply coming up with a formula or a recipe.

[00:07:46] Speaker 02:
And the district court rejected that construction and used the terms designing and developing for the verb formulate.

[00:07:52] Speaker 02:
And then for the object of the claim, the nutritional diet or diet product, as the claim may be, the district court construed those terms to mean a particular nutrient or caloric composition.

[00:08:03] Speaker 02:
So our understanding of the district court's order is that it was concluded that there was a physical process even for part of the formulating claim.

[00:08:10] Speaker 02:
And as Your Honor had noted earlier, there are certainly different types of claims in this case, and we recognize that there is a difference between the formulating claim one, for example, and the preparing claims.

[00:08:22] Speaker 02:
And we certainly recognize that it's maybe more a closer call in the formulating claims, but certainly with respect to the preparing claims, which the district court construed meant making this actual product.

[00:08:33] Speaker 02:
using definitions such as things, combining ingredients or mixing ingredients.

[00:08:38] Speaker 01:
Part of their objection is that your claims aren't limited to what you're now telling us, but that in their breadth, and it's the breadth that really seems to be the basis for their argument, that the limitations, the specificities, the advances are not in the claims.

[00:08:59] Speaker 02:
So we would disagree with their assertion that these claims are overly broad or somehow not limited in their application.

[00:09:04] Speaker 02:
I think we pointed out several examples in our briefing of ways in which you could use genomic analysis in a manner that would not be covered by these claims.

[00:09:12] Speaker 02:
For example, in the designing of a pharmaceutical product.

[00:09:15] Speaker 00:
Yeah, but it covers all genomic diets, right, for animals, for canines, right?

[00:09:24] Speaker 02:
No, it would only cover genomic diets that were prepared

[00:09:28] Speaker 02:
specifically following the analysis done by the claims.

[00:09:32] Speaker 02:
We certainly agree that our way of doing it is likely the best way of doing it.

[00:09:35] Speaker 02:
It's part of why it's had such success in terms of Hill's own use of it.

[00:09:39] Speaker 02:
But we don't think that this is the only way to take genomic information about an animal and use it in the application, in a nutritional application.

[00:09:48] Speaker 02:
The claim set forth a very specific way of looking at the data and analyzing that data.

[00:09:53] Speaker 02:
and then of coming up with a nutritional product as a result.

[00:09:57] Speaker 04:
What would be some other way of using recognized connections between nutrients and the expression of physiological feature producing genes that's not covered here?

[00:10:19] Speaker 02:
Certainly if you use that information and came up with a pharmaceutical product,

[00:10:22] Speaker 02:
That would be one example of how you would not be taking... But for an animal diet.

[00:10:28] Speaker 02:
If you're preparing a particular nutrient or caloric composition for the animal, and you've gone through the data analysis steps of comparing the first set to the second set in the way described by the claims, I can certainly imagine a way, I don't think it would be as good, of taking just, for example, one of the data sets that looks at the effect of nutrition on the expression of genomic data, and then maybe comparing that to the literature, for example,

[00:10:51] Speaker 02:
and saying, you know, I see that fish oil seems to have an impact on certain genomic data.

[00:10:58] Speaker 02:
And I've read an article that shows that those similar genomic data are associated with arthritis, for example.

[00:11:04] Speaker 02:
That could be one way of applying the information that's not covered by the claim.

[00:11:08] Speaker 04:
Even if the articles were in the database?

[00:11:11] Speaker 02:
Well, you took the article and then you put it into a database and such that that data comprised the

[00:11:16] Speaker 02:
genetic descriptor genomic data on the effect of a physiological condition, then you would likely be running into the way the claims are structured.

[00:11:23] Speaker 02:
But that would certainly be an improvement on the process that I just described.

[00:11:27] Speaker 02:
And it would be different from what the claims cover.

[00:11:30] Speaker 01:
Let's hear from the other side.

[00:11:32] Speaker 00:
Ms.

[00:11:32] Speaker 00:
Willis, before you sit down, your brief is noncompliant with the federal rules because the spacing is not correct.

[00:11:39] Speaker 00:
It has to be double spaced.

[00:11:41] Speaker 00:
It's 1.5 spaced.

[00:11:43] Speaker 02:
I apologize, Your Honor.

[00:11:45] Speaker 02:
I thought we had ensured that it was exactly 24-point font, but I... The font is correct.

[00:11:49] Speaker 00:
The spacing is wrong.

[00:11:52] Speaker 02:
I understand, Your Honor.

[00:11:53] Speaker 02:
I apologize.

[00:11:54] Speaker 02:
Would you like for us to correct the brief and resubmit it?

[00:11:59] Speaker 01:
If we need to correct the brief, we will let you know.

[00:12:01] Speaker 02:
Thank you.

[00:12:11] Speaker 01:
Mr. Hales.

[00:12:13] Speaker 03:
Thank you, your honor, and may it please the court, Brian Hales on behalf of Hill's Pet Nutrition.

[00:12:18] Speaker 03:
I think if I can pick up just on where we left off for a moment on deer, I think one of the things that's telling about Hemopet's argument is that they want to talk about deer first and almost only deer and only get to the more recent developments in this area of law at the end, if there's time.

[00:12:38] Speaker 03:
But we all know that the recent developments in this area, beginning with Mayo and then Myriad

[00:12:42] Speaker 04:
The structure of almost any argument in this area now is we still have deer, we have these other things.

[00:12:50] Speaker 04:
An argument is your side says we're closer to this and their side says we're closer to that.

[00:12:55] Speaker 04:
It's not a bad strategy to say here's why we're pretty close to the one that actually rejects the 101 challenge.

[00:13:03] Speaker 03:
That's fair, your honor.

[00:13:04] Speaker 03:
But the fact is that if you look at the later cases, the claims don't pass muster.

[00:13:08] Speaker 03:
And if you look at deer, which I'll get to now, deer is distinguishable.

[00:13:12] Speaker 03:
Because deer does recite, very specific.

[00:13:14] Speaker 01:
But where are you going with that?

[00:13:16] Speaker 01:
All of those later cases cite deer, rely on deer as providing the foundation for drawing the lines that are drawn in the later case.

[00:13:26] Speaker 01:
And so what about, where is this case on the wrong side of the line, as counsel has told us?

[00:13:35] Speaker 01:
There are certain measurements that are performed, as in deer, which

[00:13:41] Speaker 01:
bring out information not previously available, as in deer.

[00:13:45] Speaker 01:
It may very well be, as I had asked counsel, that there seems to be a bit of overreaching in saying any genetic analysis will take us where we are.

[00:13:57] Speaker 01:
But I haven't seen that response.

[00:14:01] Speaker 03:
Well, how these claims go across the line, Your Honor, is that they don't do anything other than recite the natural correlations between

[00:14:09] Speaker 03:
the genes and their relationship to disease and nutrients and their effect on gene expression.

[00:14:16] Speaker 03:
Those are clearly natural correlations.

[00:14:18] Speaker 01:
But if you discover a natural correlation, it's quite different from as in Mayo where the natural correlation was known.

[00:14:27] Speaker 03:
Well, no, Your Honor.

[00:14:27] Speaker 03:
I think if you look at cases like Mayo, Myriad, and even Ariosa recently,

[00:14:33] Speaker 03:
the discovery of natural correlations doesn't give a party the right to claim those natural correlations and tie them up from future use.

[00:14:41] Speaker 01:
It depends.

[00:14:41] Speaker 01:
Every invention is a discovery of something that's there.

[00:14:49] Speaker 03:
Certainly, Your Honor, but in cases like Myriad, the Supreme Court has said that even seminal, fundamental, very, very important revolutionary discoveries, if the claims are

[00:15:01] Speaker 03:
too closely tied to just the natural law itself.

[00:15:05] Speaker 03:
One's not entitled to a patent on that.

[00:15:06] Speaker 03:
That's the basis.

[00:15:07] Speaker 00:
Yeah, but I think maybe you're going too far in that.

[00:15:10] Speaker 00:
If what they'd claimed is a discovery that a combination of calcium and a couple of other minerals as a result of this process prevented hip dysplasia in dogs or something like that, I mean, that might well be patentable if that was novel.

[00:15:31] Speaker 00:
The problem here is not so much that it's a natural law as the abstractness and breadth of it.

[00:15:38] Speaker 03:
I agree, Your Honor, and that's what I was getting to next, because the question under the Alice-Mail framework is, once we know that there are natural relationships recited, is there something that transforms it?

[00:15:49] Speaker 03:
And the only other elements we have are generic computer elements, which are rejected under Alice as transforming something into patentable subject matter.

[00:15:58] Speaker 03:
and analyze or determine the relationship step.

[00:16:01] Speaker 00:
It's just a patent on a method of analysis, rather than coming up with a particular product which does something useful.

[00:16:11] Speaker 03:
That's right.

[00:16:12] Speaker 03:
And these claims, at the end, the final step, which is where they spend the most of their effort, it's the prepare, formulate, or determine a composition claim, which they argue is tangible.

[00:16:24] Speaker 03:
There's not actually any tangible thing recited to be clear in any of these claims.

[00:16:28] Speaker 03:
It's a suggestion to go make something in the best case scenario for them.

[00:16:33] Speaker 03:
I think that Toronto is right that there's ambiguity in what some of the other terms mean.

[00:16:37] Speaker 03:
But even in the best case scenario for them where it says make, if it says make a food or make a composition, it's still abstract.

[00:16:46] Speaker 03:
It's still abstract.

[00:16:47] Speaker 04:
There's nothing abstract about the thing that's going to go into the dog's mouth.

[00:16:51] Speaker 03:
But the claims don't recite the thing that's going to go into the document.

[00:16:54] Speaker 04:
Food product.

[00:16:54] Speaker 04:
It's not specific.

[00:16:55] Speaker 04:
I thought there was at least one claim that talked about actually making a food product.

[00:17:01] Speaker 03:
Is that wrong?

[00:17:02] Speaker 03:
That's a direction or suggestion that based on analysis that was done of the natural correlations that somebody make a food product.

[00:17:12] Speaker 03:
But there's no claim to a composition anywhere in here that says,

[00:17:16] Speaker 03:
the composition of food for dogs or cats reciting the following ingredient.

[00:17:20] Speaker 04:
Can I just switch back to one thing and clarify this?

[00:17:26] Speaker 04:
Is it right that all of these claims, the searching of databases, the analysis of the information you get out of the database, would cover situations in which everything in the database was old and well known and not any new discovery at all?

[00:17:45] Speaker 03:
I think it would, Your Honor.

[00:17:47] Speaker 03:
Absolutely.

[00:17:47] Speaker 03:
In fact, these claims are, they don't specify anything to be known versus unknown.

[00:17:54] Speaker 03:
They cover all of the correlations and as I think was discussed.

[00:17:58] Speaker 04:
So unlike even in Mayo, these patents don't involve the finding of even a new natural phenomenon, just checking information

[00:18:08] Speaker 04:
that is on a certain subject, even if that information is old.

[00:18:12] Speaker 03:
That's right, and that's true for each of the steps, right?

[00:18:15] Speaker 01:
But 20 years ago, you're not telling us all this was known for the first filings?

[00:18:22] Speaker 03:
The idea that nutrients could affect health has been known for generations, and the idea that nutrients could affect gene expression was absolutely known before these patents were filed.

[00:18:33] Speaker 03:
which is shown by our submission for an alternative basis to uphold the finding on three of the patents under PCT Guy, which recite exactly these things.

[00:18:43] Speaker 03:
And PCT Guy, nearly verbatim, says that we can study how nutrients affect the expression of genes and study which genes are related to disease conditions or health conditions.

[00:18:54] Speaker 04:
So I guess I was just trying to pick up on, I think, what Judge Dyke was referring to,

[00:19:00] Speaker 04:
The core of the 101 problem here is not so much that it's about natural phenomena.

[00:19:06] Speaker 04:
It is that it is about reading and analyzing information at quite high level of generality.

[00:19:16] Speaker 04:
Wherever the information may have originated 20 years ago or two days ago.

[00:19:23] Speaker 03:
I think that's right and the third and fourth steps, the first two steps are clearly referred to national information and the third and fourth steps which are the only steps left that could transform this claim are wholly generic, wholly abstract and recited just as the district court said at such a high level as to not be sufficient to transform the claims.

[00:19:42] Speaker 03:
Mayo is actually very instructive on this point because one of the things that the Supreme Court in Mayo said about the claims at issue there was that they

[00:19:51] Speaker 03:
They told doctors about a natural law and suggested that doctors take it into account when treating their patients.

[00:19:58] Speaker 03:
And they went on to state it slightly differently, which is important.

[00:20:02] Speaker 03:
The claims were characterized there as telling the relevant audience about natural laws and entrusting them to use the laws appropriately where relevant to their decision making.

[00:20:14] Speaker 03:
And that was the reason.

[00:20:15] Speaker 01:
That's really an overstatement.

[00:20:17] Speaker 01:
They were dealing with a specific product

[00:20:20] Speaker 01:
with a known metabolite that was known to exist in the blood.

[00:20:24] Speaker 01:
It was a narrow set of facts that took the court to make some important statements based on situations such as that.

[00:20:37] Speaker 01:
Here we have, and perhaps it's a legitimate criticism of this case, of the breadth with which it's presented.

[00:20:45] Speaker 01:
But again, you do have to look back at the time this invention was made.

[00:20:50] Speaker 01:
20 years ago, you couldn't just push a button and have the entire genome, whether of dog or cat or of any of us, appear.

[00:21:01] Speaker 03:
Right.

[00:21:01] Speaker 03:
But I think, as I said, with respect to PCT guy that we have in the submission, Your Honor, these steps were known.

[00:21:06] Speaker 03:
I think one important point is that these claims are not limited to analyses of the whole genome.

[00:21:12] Speaker 01:
Yeah, that's a fair criticism.

[00:21:14] Speaker 01:
But some of them are quite specific.

[00:21:19] Speaker 01:
Well, some are quite broad.

[00:21:22] Speaker 03:
I think I disagree.

[00:21:22] Speaker 03:
I think they're actually all very broad.

[00:21:24] Speaker 03:
None of these claims recite anything more specific than just the general recitation of looking at these natural correlations, the natural genes related to disease and how nutrients affect gene expression.

[00:21:38] Speaker 03:
And then a generic recitation of analyzing that information or determining the relationships.

[00:21:44] Speaker 03:
No claim is more specific than that.

[00:21:46] Speaker 03:
And then finally, formulating or preparing

[00:21:49] Speaker 03:
or determining a food composition.

[00:21:52] Speaker 03:
Nothing is more specific than that.

[00:21:54] Speaker 03:
And so although Hemopet wants to focus on the notion of high throughput genomics and vast volumes of data and rich amounts of data, the claims don't recite or require that.

[00:22:08] Speaker 03:
These claims are broad enough to encompass looking at a single gene, looking at a single nutrient, and making the mere decision whether to add that nutrient

[00:22:18] Speaker 03:
to a food or diet product if it's good for health or remove it if it's bad for health or not use it if it's bad for health.

[00:22:25] Speaker 03:
And that we submit is absolutely the type of mental process that has been routinely rejected by the Supreme Court and this court in the recent jurisprudence.

[00:22:35] Speaker 03:
It's just too vague and too abstract.

[00:22:38] Speaker 03:
It's purely post-solution conventional activity because people have known for generations, right,

[00:22:48] Speaker 03:
to when we find something that's good for our health, make a food out of it or add it to food.

[00:22:53] Speaker 03:
And we find something that's bad for our health or an animal's health, we remove it from food or try to make a food without it.

[00:22:59] Speaker 03:
That's the only reference that exists at the end of these claims is to, based on what we saw before or what we saw in the natural correlations, make a decision whether or not to add something good or remove something that's bad.

[00:23:13] Speaker 03:
There are pet food products out there that are offered as good for

[00:23:18] Speaker 03:
the health of your animal's teeth and gums.

[00:23:23] Speaker 03:
It's purely conventional and insignificant post-solution activity, the third and even the fourth step of their process, because those things have been done forever in various contexts.

[00:23:35] Speaker 03:
The only thing different, reciting these claims, is the input.

[00:23:39] Speaker 03:
Instead of talking about adding protein or removing fat or putting vitamins into a diet, we have a different set of inputs, but those inputs are

[00:23:48] Speaker 03:
the natural relationships between genes and nutrition, or sorry, nutrients and the expression of genes and genes and their relation to disease.

[00:23:57] Speaker 00:
That's the only difference.

[00:23:58] Speaker 00:
Well, but the point is it was well known to look to that relationship.

[00:24:02] Speaker 00:
I'm sorry, Your Honor?

[00:24:02] Speaker 00:
It was well known to look to that relationship before this patent was the priority date.

[00:24:09] Speaker 03:
I think it's both conventional because that's the most natural and logical thing to do with information that you glean about how nutrients affect

[00:24:17] Speaker 03:
the body or effect gene expression, and it was also known to do it this way because it had been done before in VCT guide.

[00:24:26] Speaker 03:
So I think if I go back to the point about the scope of the claims, this decision under section 101 is based on what the claims are, how they're written, and what they cover, not a narrow selective example of a high throughput scenario that hemopet would like to focus on.

[00:24:45] Speaker 03:
Unless there are more questions, I think I covered the points that I wanted to emphasize today.

[00:24:48] Speaker 01:
Any more questions?

[00:24:52] Speaker 01:
More questions?

[00:24:53] Speaker 01:
Okay.

[00:24:53] Speaker 01:
Thank you, Mr. Hayes.

[00:24:54] Speaker 01:
Ms.

[00:24:54] Speaker 01:
Rubius.

[00:25:00] Speaker 02:
May I proceed?

[00:25:01] Speaker 02:
Yes, please.

[00:25:02] Speaker 02:
I want to start on this last point, the idea that somehow genomic information has been understood and known for a long time with respect to formulating nutrition.

[00:25:10] Speaker 02:
That's not the case.

[00:25:12] Speaker 02:
Certainly any life science field is an evolutionary process, and we don't dispute that.

[00:25:16] Speaker 02:
The idea of nutrients affecting the expression of single genes was around for a while, but genomic data is a new animal, pardon the pun.

[00:25:26] Speaker 02:
It's a new way of looking at information that wasn't around at the time of these patents that Hills themselves was not using in formulating their own diets until around 2003 and later.

[00:25:35] Speaker 04:
Since all of your claims talk quite generically about databases,

[00:25:41] Speaker 04:
Why isn't a tiny little computer library with one gene recited in it about which, as you say, it was understood that nutrition could affect the degree of expression of that gene?

[00:25:57] Speaker 04:
Why wouldn't all of your claims read on that?

[00:26:00] Speaker 02:
Because that would not qualify under the construction of the terms genomic map data and genomic data, which can include, as part of the data point, the expression of genes.

[00:26:10] Speaker 02:
But it's the relationship, it's not just the way one gene expresses itself, it's data on the relationship between those genes and the other genomic information.

[00:26:18] Speaker 02:
That's what's new about this data.

[00:26:20] Speaker 02:
And it's actually very similar to how this court ruled in the Klassen opinion, which was a few years ago and was also part of the more recent Life Sciences opinion, which as far as we understand is still good law, and Hill has not made any effort to distinguish our claims from the claims held eligible in Klassen, aside from to suggest that Klassen is no longer valid.

[00:26:40] Speaker 02:
But these claims, which to look at the Klassen opinion, there were three separate claims in that case, one of which was held ineligible as merely an example of looking at an immunization schedule and determining an immunization schedule based on literature.

[00:26:56] Speaker 02:
And that was held ineligible.

[00:26:58] Speaker 02:
But the two claims that were held eligible in Klassen took that information, took that process of analysis.

[00:27:04] Speaker 02:
and then apply it by going out and immunizing pursuant to that schedule.

[00:27:08] Speaker 04:
Can I just return to the subject of my last question?

[00:27:13] Speaker 04:
What aspect of the claim construction would read some term?

[00:27:18] Speaker 04:
I think you were focusing on one of the bits of language about genomic map data as requiring something more than

[00:27:31] Speaker 04:
a nucleotide sequence that would amount to one gene.

[00:27:35] Speaker 04:
I mean, as I'm reading the claim construction, genomic map is map of part of the DNA sequence of an organism.

[00:27:41] Speaker 04:
That's not a lot.

[00:27:44] Speaker 02:
So I would direct your attention to the part of the judge's opinion.

[00:27:47] Speaker 02:
It's actually the earlier section where she construed genomic data.

[00:27:50] Speaker 04:
In the claim construction?

[00:27:51] Speaker 02:
In the claim construction order.

[00:27:52] Speaker 02:
Part of Hilda's challenge had been with respect to whether or not genomic data could include gene expression data at all.

[00:27:59] Speaker 02:
And they had tried to suggest that there was... Gene expression data.

[00:28:02] Speaker 04:
I'm just talking about nucleotide sequences here.

[00:28:06] Speaker 04:
Are we talking about different things?

[00:28:08] Speaker 02:
So I guess if we're just talking about nucleotide sequences, I don't think that's part of the court's construction of genomic data or genomic map data.

[00:28:14] Speaker 02:
I thought you were referring to the way the gene would then go and express itself.

[00:28:18] Speaker 02:
But I don't think within the construction of genomic map data, which the court construed as a portion of the genomic map, which are the sets of genes, that you would be able to qualify for that with just a string of nucleotides.

[00:28:32] Speaker 02:
But to conclude, I just want to point out that these claims are absolutely directed to a physical process.

[00:28:38] Speaker 02:
And whether or not they want to make an indefiniteness challenge about them at a later date, if they have that ability, that's a different question than whether or not they're directed to patent-eligible subject matter.

[00:28:48] Speaker 02:
And as this court held in Klassen and as this Supreme Court held in Deer, claims that are directed to a physical process, even if they take conventional steps and even if they consider relationships that in a vacuum might be considered

[00:29:02] Speaker 02:
abstract or laws of nature, that the specific application of that technology in a specific way, as the hemopet claims does, makes them eligible under 101.

[00:29:11] Speaker 02:
So unless there are further questions, I thank you for your time.

[00:29:16] Speaker 01:
Okay.

[00:29:16] Speaker 01:
Okay.

[00:29:17] Speaker 01:
Thank you, Ms.

[00:29:17] Speaker 01:
Lewis.

[00:29:17] Speaker 01:
Mr. Hales, the case is taken under submission.