[00:00:04] Speaker 02:
Well, first, for what is likely the most enjoyable part of the morning, I turn to Judge Moore for a motion.

[00:00:10] Speaker 04:
I would like to move the admission of my law clerk.

[00:00:14] Speaker 04:
Please stand up, Reba.

[00:00:16] Speaker 04:
I move the admission of Rebecca L. Rabenstein, who is a member of the bar and is in good standing with the highest court of New York.

[00:00:24] Speaker 04:
I have knowledge of her credentials.

[00:00:26] Speaker 04:
I'm satisfied she possesses the necessary qualifications.

[00:00:30] Speaker 04:
Reba has been my clerk for more than a year.

[00:00:33] Speaker 04:
She came to me from a firm life, many years of experience with a Ph.D.

[00:00:39] Speaker 04:
in chemistry, and she has been a joy to work with for me and all of her co-clerks, as well as brought a wealth of knowledge and experience to my chambers.

[00:00:48] Speaker 04:
So I've been very fortunate to have her.

[00:00:50] Speaker 04:
I have no doubt that she's going to make an excellent new member of our bar.

[00:00:54] Speaker 04:
So Reba, if my motion is granted, I'll ask you to turn to the Admiral.

[00:00:58] Speaker 04:
Is it granted?

[00:00:59] Speaker 04:
Yes.

[00:00:59] Speaker 04:
Okay, very good.

[00:01:02] Speaker 01:
I do.

[00:01:14] Speaker 02:
Congratulations.

[00:01:15] Speaker 02:
Welcome to the bar.

[00:01:18] Speaker 03:
All right.

[00:01:18] Speaker 02:
First case this morning is 151570, Rapid Litigation Management versus Self-Direct Incorporated.

[00:01:26] Speaker 02:
Mr. Pintas, whenever you're ready.

[00:01:32] Speaker 01:
Thank you, your honor, and may it please the court.

[00:01:34] Speaker 01:
The question in this case is whether the 929 patent is invalid under section 101 on the ground that it's directed to a law of nature.

[00:01:45] Speaker 01:
Our submission is that it qualifies as patentable under both steps of the Mayo-Alice analysis.

[00:01:49] Speaker 01:
Turning first to step one, this patent is fundamentally different from the ones at issue in Mayo and Sequinon.

[00:01:56] Speaker 01:
Those patents were directed to a phenomenon occurring in nature

[00:02:00] Speaker 01:
that the inventor had observed, and they claimed processes to detect the naturally occurring phenomena and to explain the consequences of it.

[00:02:09] Speaker 02:
But I think among the things that your friend on the other side would say is this capacity for the cells to survive the second freezing is really an inherent property, and therefore it falls under male myriad, et cetera.

[00:02:22] Speaker 02:
Why is that wrong?

[00:02:23] Speaker 01:
I think that proves too much, Your Honor, because anything that

[00:02:28] Speaker 01:
non-natural human treatment of naturally occurring objects, the results of that non-natural treatment is according to a natural law by definition.

[00:02:38] Speaker 01:
When iron ore is placed in a high temperature and carbon is added, steel is produced.

[00:02:44] Speaker 01:
That's all as a result of natural laws, but no one would say that that's not a patentable process.

[00:02:49] Speaker 01:
So I think there's a fundamental difference between a patent that's directed to observing something that occurs in nature and one that's directed

[00:02:58] Speaker 01:
to not detecting something that occurs naturally, but employing processes that do not occur in nature, which is what happens here.

[00:03:06] Speaker 01:
There's no multiple freezing in nature.

[00:03:08] Speaker 02:
So if we had a claim that took the isolated DNA of myriad and said, we're freezing that, that's the method claimed, would that be patentable in your view?

[00:03:17] Speaker 02:
Would the Supreme Court think that would have made it patentable?

[00:03:20] Speaker 01:
Well, I think there are two things that happen here.

[00:03:23] Speaker 01:
One is subjecting it to a non-natural process.

[00:03:26] Speaker 01:
The second is that the product is something that doesn't occur in nature.

[00:03:32] Speaker 01:
Here, the frozen collection of multiple pooled cells that has a longer shelf life and that is useful.

[00:03:40] Speaker 01:
So I think to some extent, the inquiries under step one and step two merge.

[00:03:44] Speaker 01:
But I think our submission under step one is that if that discovery were to subjecting that

[00:03:56] Speaker 01:
a naturally occurring object to a non-natural process yields something that doesn't occur in nature, then yes, that would be satisfying.

[00:04:02] Speaker 04:
But then the Supreme Court dealt with this in Myriad already.

[00:04:06] Speaker 04:
I don't even understand why you're hinging your argument on this.

[00:04:09] Speaker 04:
I don't think you need it in order to prevail, given that these are method claims.

[00:04:14] Speaker 04:
And I thought, aren't these claims just directed to a method of preserving cells by freezing them in the environment?

[00:04:21] Speaker 04:
where the prior art suggested very much not to do that?

[00:04:24] Speaker 04:
Isn't this just a method of preservation?

[00:04:27] Speaker 04:
And if so, why isn't it necessarily patent eligible for that reason?

[00:04:30] Speaker 04:
Why do you need to make all this argument about the parasite cells and whether they're found in nature or not?

[00:04:35] Speaker 01:
Well, I think we have a very strong argument under step two of the approach, as Your Honor suggests, because as this court observed in its prior decision in this case... No, this is not step two.

[00:04:46] Speaker 04:
My point is that under Myriad, where the Supreme Court went extensively to lengths to say, we're not addressing method claims here.

[00:04:55] Speaker 04:
And they made it very, very clear.

[00:04:56] Speaker 04:
It's important to note what is not implicated by this decision.

[00:04:59] Speaker 04:
There are no method claims before this court.

[00:05:01] Speaker 04:
That's what they said.

[00:05:03] Speaker 04:
These are a method of preserving cells, right?

[00:05:07] Speaker 04:
Isn't that what this claim is directed to?

[00:05:09] Speaker 01:
Absolutely.

[00:05:10] Speaker 04:
How can any claim directed to a method of preserving cells be patented and eligible?

[00:05:16] Speaker 01:
We're very happy to agree with Your Honor on that, absolutely on that point.

[00:05:21] Speaker 01:
There have been some thought in some of the cases that the type of patent method versus not wasn't dispositive.

[00:05:30] Speaker 04:
We think the fact that this is... Well, because Prometheus was a method claim, but that's different.

[00:05:33] Speaker 04:
It was a method of detecting an inherent trait.

[00:05:36] Speaker 04:
This isn't a method of detecting anything about their survivability in

[00:05:41] Speaker 04:
in frozen, it's a method of actually freezing them and then having a group of usable cells afterwards, right?

[00:05:47] Speaker 01:
That is exactly the point that I was making probably not as clearly as your honor, that Prometheus was about detection and this is about a method of acting upon the cells to put them in a different state and that that's fundamentally different because it's subjecting them to this

[00:06:04] Speaker 01:
Non-natural process.

[00:06:05] Speaker 01:
Okay, stop.

[00:06:06] Speaker 04:
See, this is where you've lost me.

[00:06:07] Speaker 01:
Okay.

[00:06:07] Speaker 04:
You're again going into the argument, which I will not agree with you on because Myriad has foreclosed it.

[00:06:12] Speaker 04:
When you extract and isolate DNA, you have done something to remove it from its naturally occurring state.

[00:06:19] Speaker 04:
Just like when you freeze these cells, you've done something to remove them from their naturally occurring state, but that doesn't change their underlying nature according to the Supreme Court and make them patent eligible.

[00:06:30] Speaker 04:
So I don't know that you could get me to go with you on the cells if these were cell claims.

[00:06:36] Speaker 04:
But the key is they're not.

[00:06:39] Speaker 01:
No, we're not trying to.

[00:06:40] Speaker 01:
And we're very happy to rest on the fact that this is a method.

[00:06:43] Speaker 01:
And it is not a method for detection.

[00:06:45] Speaker 01:
And that takes it out of Mayo.

[00:06:47] Speaker 01:
And we think for that reason, we pass muster under step one.

[00:06:51] Speaker 01:
And if there was any doubt about that, turning to step two,

[00:06:55] Speaker 01:
We think that the process is anything, it certainly doesn't meet the quite low standard of conventional or routine or industry standard.

[00:07:04] Speaker 02:
This is something that as the court... What if we thought this was construed as being a product by process claim?

[00:07:10] Speaker 02:
Would that change the analysis, the difference between that, construing it as that versus a method claim?

[00:07:18] Speaker 01:
Well, I think A, it clearly is a method claim, but I think the fact that we are not

[00:07:25] Speaker 01:
I think then we would have to put more weight on where Judge Moore doesn't want to go and to look at what's going on here and I think we would still say that what comes out at the end is something that is different.

[00:07:36] Speaker 01:
But I don't think the court has to go there because this is quite clearly a method claim.

[00:07:40] Speaker 03:
You mentioned multi-pooled earlier and when you were describing the claims.

[00:07:46] Speaker 03:
Is that in claim one or is that really in claim five?

[00:07:48] Speaker 03:
Yes.

[00:07:52] Speaker 01:
So just to elaborate on the step two point, I think even if we somehow were to flunk step one, we don't think we do for the reasons we've discussed.

[00:08:03] Speaker 01:
But step two requires only something that's not conventional and not routine.

[00:08:09] Speaker 01:
And we think we have that here.

[00:08:12] Speaker 01:
The district court, we think, made a couple of errors in law in applying that test.

[00:08:16] Speaker 01:
First of all, it set the bar too high.

[00:08:19] Speaker 01:
It seemed to set the bar much closer to novelty

[00:08:23] Speaker 01:
Second of all, it didn't evaluate the steps as a group.

[00:08:25] Speaker 01:
It dissected them.

[00:08:26] Speaker 04:
Just to be curious, you started by saying they made a couple of errors of law.

[00:08:29] Speaker 04:
Aren't these factual questions, not legal questions?

[00:08:32] Speaker 04:
So wouldn't these be problematic under, because aren't these facts?

[00:08:39] Speaker 04:
Isn't whether or not cryopreserving is a non-obvious step to

[00:08:46] Speaker 04:
factual question, or shouldn't it be?

[00:08:48] Speaker 04:
Have we necessarily resolved that it's a question of law?

[00:08:52] Speaker 01:
I don't think the court has necessarily resolved it.

[00:08:53] Speaker 01:
We think it's an ultimate question of law, but even if it weren't an ultimate question of law... No, you mean the 101 question is ultimately a question of law?

[00:09:00] Speaker 04:
Yes.

[00:09:00] Speaker 04:
Or do you mean whether or not cryopreserving adds a novel element

[00:09:08] Speaker 04:
to the claim.

[00:09:09] Speaker 04:
Do you think that's a questionable?

[00:09:10] Speaker 01:
I think it's probably a mixed question of law and fact, Your Honor.

[00:09:13] Speaker 01:
I think there obviously are subsidiary questions that are wholly factual.

[00:09:17] Speaker 01:
What was the prior art?

[00:09:18] Speaker 01:
What was the teaching?

[00:09:20] Speaker 04:
But I think ultimately... Because novelty, you know, novelty anticipation is itself a question of fact, right?

[00:09:25] Speaker 04:
So if I'm looking at this claim to see if any of the elements add a novel aspect, why wouldn't that be a question of fact?

[00:09:32] Speaker 01:
Well, a couple of things.

[00:09:34] Speaker 01:
I think I don't want to quarrel too much with the

[00:09:38] Speaker 01:
underlying point of your honor's question, but I think it's important to recognize and I think this is a case where the court could make clear that the step two inquiry here is not anticipation or novelty.

[00:09:49] Speaker 01:
It's something that puts much less of a burden on the patentee.

[00:09:52] Speaker 02:
Can I ask you just a general question of what's going on in this litigation?

[00:09:56] Speaker 02:
Because this was previously the subject of a preliminary injunction, right?

[00:10:00] Speaker 02:
What's the status of the injunction?

[00:10:01] Speaker 02:
So the injunction has been dissolved, presumably.

[00:10:03] Speaker 01:
Well, the defendant has designed around the injunction, and that design around has been held not to infringe the patent.

[00:10:13] Speaker 02:
So what remains of this litigation?

[00:10:15] Speaker 01:
There are damages.

[00:10:17] Speaker 01:
There's retrospective liability.

[00:10:19] Speaker 02:
And all of the other validity challenges have been disposed of?

[00:10:23] Speaker 01:
No, they haven't been addressed.

[00:10:24] Speaker 01:
This is where we are in the litigation.

[00:10:27] Speaker 03:
Am I correct in understanding that the design around with respect to the density gradient fractionization?

[00:10:34] Speaker 01:
Yes, Your Honor.

[00:10:35] Speaker 01:
It's respect to that.

[00:10:37] Speaker 01:
But just turning back to step two, I think there certainly are legal questions, whether the ultimate question is one, a fact or law, or a mixed question, a fact or law, on whether the steps are conventional or routine or not.

[00:10:53] Speaker 01:
There certainly are a couple of questions.

[00:10:55] Speaker 01:
First of all, what is the standard for non-conventional and non-routine?

[00:10:58] Speaker 01:
We think it's, as I said, a low standard.

[00:11:01] Speaker 01:
It's basically, is there something other than the industry, something that was standard in the industry here?

[00:11:06] Speaker 01:
There's a legal question about whether, as the district court did, you look at the steps one by one and dissect them, or whether, as Deer says, you have to look at them as a group.

[00:11:14] Speaker 01:
We think that's a legal question.

[00:11:16] Speaker 01:
And the district court also seemed to take the position that

[00:11:20] Speaker 01:
a step was conventional if it turned on something that was the result of an act of nature, the results of freezing.

[00:11:27] Speaker 01:
That can't possibly be right, because that would mean that no step in this area where everything depends on the consequences of a law of nature in a non-natural environment.

[00:11:38] Speaker 01:
That can't possibly be right.

[00:11:40] Speaker 01:
And finally, there has to be something in the record.

[00:11:43] Speaker 01:
The district court here seemed to really make a sort of a gut decision on, gee, this seems conventional.

[00:11:49] Speaker 01:
without looking at the facts in terms of the prior art and other factual evidence, and that seems clearly wrong.

[00:11:57] Speaker 01:
Okay, why don't we hear from the other side?

[00:11:58] Speaker 01:
Thank you.

[00:11:59] Speaker 02:
Thank you.

[00:12:05] Speaker 00:
Mr. Mangum, good morning.

[00:12:06] Speaker 00:
Good morning.

[00:12:07] Speaker 00:
May it please the court, David Mangum for Cells Direct.

[00:12:11] Speaker 00:
The 929 patent claims here are ineligible under the two-part Mayo and Alice test because they are directed to a law of nature, a phenomenon of nature, the natural ability of some hepatocyte cells to survive multiple freeze-thaw cycles.

[00:12:27] Speaker 02:
But what's happening here is through the intervention of a person, right?

[00:12:32] Speaker 02:
This is not occurring without the intervention of a person.

[00:12:35] Speaker 00:
Correct.

[00:12:35] Speaker 00:
But also in Mayo, the application required the intervention of a human to prescribe and provide the drug.

[00:12:44] Speaker 00:
And then the reaction that took place within the body was the natural reaction here.

[00:12:49] Speaker 00:
And really here, the claims themselves call out a natural phenomenon.

[00:12:56] Speaker 02:
Well, cells don't by themselves live indefinitely.

[00:13:00] Speaker 02:
They're not viable indefinitely in the absence of this method being performed on them, right?

[00:13:06] Speaker 00:
They do not, unless they are cryopreserved.

[00:13:08] Speaker 00:
And then when they are used, of course, they are then thawed and put back in and performed in exactly the same way they did before.

[00:13:16] Speaker 00:
And I would submit that this claim is directed to detection just the same way as the claims in myriad.

[00:13:24] Speaker 00:
What you have here is detecting the ability of these cells, the ones that are capable of being frozen and thawed multiple times.

[00:13:33] Speaker 00:
In myriad and in sequinom, you detect the presence by amplifying the number of cells, so there's a multiplication process.

[00:13:45] Speaker 00:
Here, you detect

[00:13:47] Speaker 00:
those cells that are capable of surviving the multiple freeze-thaw cycle through subtraction.

[00:13:52] Speaker 00:
You isolate the ones that are capable of surviving from those that aren't capable of surviving, and therefore detect their presence.

[00:14:00] Speaker 00:
And what's claimed here is expressly a method of producing a desired preparation of multi-crow preserved hepatocytes, said hepatocytes being capable of being frozen and thawed at least two times.

[00:14:14] Speaker 00:
So I think what would distinguish this

[00:14:16] Speaker 00:
patent in this claim from others is that right in the patent itself, you call out the natural phenomenon.

[00:14:25] Speaker 00:
The ability, the capability of a subpopulation of these cells to survive multiple freeze-thaw cycles is expressly stated in the claim.

[00:14:34] Speaker 00:
Now, it may very well be that someone could draft a claim for processes, including processes of crowd preservation,

[00:14:43] Speaker 00:
that would survive a 101 analysis.

[00:14:46] Speaker 00:
But here, the way this claim is drafted, it expressly calls out the very law of nature, the very natural phenomenon that is precluded by 101.

[00:14:58] Speaker 03:
How do you respond to the point made in Bio's brief that these cells aren't frozen twice in nature?

[00:15:05] Speaker 03:
That's not something that occurs naturally.

[00:15:08] Speaker 00:
Well, and DNA is not subjected to

[00:15:13] Speaker 00:
high temperatures to break their covalent bonds and then spliced into to create primers with regard to that.

[00:15:21] Speaker 03:
But that wasn't a method claim.

[00:15:22] Speaker 03:
And as Judge Moore pointed out, that is not a method.

[00:15:27] Speaker 03:
That case did not involve a method claim.

[00:15:29] Speaker 03:
And here you've got a method claim with a very specific process where even one of the steps has been able to be designed around.

[00:15:38] Speaker 00:
Right.

[00:15:38] Speaker 00:
But the process itself is directed at detecting

[00:15:43] Speaker 00:
just as in Mayo and just as in Ariosa and Sequanon, detecting the presence, detecting the capability of these cells to survive multiple free-slot cycles.

[00:15:54] Speaker 03:
And just as in Sequanon... I thought it was producing, not detecting.

[00:15:59] Speaker 00:
Well, yes, but you're producing a preparation that consists of the subpopulation of cells that are capable of surviving multiple free-slot cycles.

[00:16:09] Speaker 00:
So I submit that it's equivalent to

[00:16:12] Speaker 00:
to identifying, if you will, those cells that are capable of surviving the multiple freeze-thaw cycle.

[00:16:19] Speaker 00:
And then you are now isolating those cells that are capable of surviving from those that aren't capable of surviving.

[00:16:28] Speaker 00:
And now you are continuing on with a product that consists entirely of cells that exist exactly like they did

[00:16:39] Speaker 00:
in nature, they have the same properties.

[00:16:41] Speaker 03:
So the individual cells exist like they did in nature, even if the collection as a whole didn't exist as it did in nature.

[00:16:48] Speaker 00:
Well, all of the cells that end up in the ultimate product also existed at the start.

[00:16:56] Speaker 00:
There's no replication, amplification of those.

[00:17:00] Speaker 03:
Even for claim five?

[00:17:02] Speaker 00:
Well, for claim five, yes.

[00:17:04] Speaker 00:
All of those cells started at the front.

[00:17:06] Speaker 00:
All you've done in claim five is put together

[00:17:09] Speaker 00:
cells that came from different donor livers together in the same preparation.

[00:17:15] Speaker 00:
So just as in Funk Brothers, what you end up with is a combination of those individual cells that exist in nature, and they operate exactly the way that they did in nature once you applied them.

[00:17:29] Speaker 03:
But you would agree that there are different methods by which you could achieve that.

[00:17:33] Speaker 03:
I mean, it is a method claim, and the steps in the method claim

[00:17:38] Speaker 03:
need not be followed in order to produce the twice preserved hepatocytes that you end up with.

[00:17:49] Speaker 00:
Well, if I understand your honor's question, there may be alternative methods that you could use at different steps in terms of cell separation, but these claims purport to cover every

[00:18:03] Speaker 00:
aspect of which you could perform a second cryopreservation.

[00:18:07] Speaker 00:
There's no limitation with regard to the step that applies the natural phenomenon here.

[00:18:13] Speaker 00:
You take these cells and any way that you subject them to a second cryopreservation so that they'll... You have to look at all the steps as a whole, right?

[00:18:21] Speaker 03:
Correct.

[00:18:22] Speaker 03:
And do I understand correctly that your client no longer performs step A?

[00:18:29] Speaker 00:
Well, yes.

[00:18:30] Speaker 00:
My client uses a different technique for cell separation.

[00:18:34] Speaker 00:
It doesn't require the density of the cell to distinguish between them.

[00:18:39] Speaker 00:
But in terms of what's preempted here and in terms of its application, I think you have to look at the aspect of the claim that deals with the natural phenomenon at issue.

[00:18:51] Speaker 03:
So you wouldn't look at the entire claim?

[00:18:55] Speaker 00:
You look at the entire claim to determine its application and for determining

[00:19:00] Speaker 00:
infringement, but with regard to this process, this method purports to cover, in terms of the cryopreservation step, any type of cryopreservation that's performed on these cells that have been subjected to a prior freeze-thaw, and then after you have identified those that are capable of surviving the second freeze-thaw cycle.

[00:19:24] Speaker 00:
So just as in Ariosa and Sequinon, the process here

[00:19:29] Speaker 00:
begins and ends with a product of nature, a natural phenomenon.

[00:19:35] Speaker 00:
And because of that, it's directed to it.

[00:19:37] Speaker 00:
And in fact, it expressly calls out here the natural phenomenon.

[00:19:42] Speaker 04:
Marriott, I read from it before when it says, it's important to know what is not implicated by this decision.

[00:19:47] Speaker 04:
First, there are no method claims before this court.

[00:19:50] Speaker 04:
The next sentence is even more interesting.

[00:19:52] Speaker 04:
How will you contend with this?

[00:19:53] Speaker 04:
Because it goes on to say,

[00:19:55] Speaker 04:
Had Myriad created an innovative method for manipulating the genes while searching for BRCA1, it could possibly have sought a method patent.

[00:20:03] Speaker 04:
Why isn't this an innovative method of manipulating hepatocyte cells?

[00:20:10] Speaker 00:
Well, it's admitted in this record that the process of separating the viable cells from the non-viable cells is conventional and well understood.

[00:20:23] Speaker 00:
And here, the only aspect of this method that is new is the application of a conventional cryopreservation step using conventional methods to cells that had been previously frozen.

[00:20:38] Speaker 04:
Except that while the notion of cryopreservation is absolutely conventional, it was counter-indicated with regard to hepatocyte cells because they didn't generally

[00:20:53] Speaker 04:
survive.

[00:20:54] Speaker 04:
And so here we have this method of separating out the ones most likely to survive and subjecting them to these, you know, there's multiple freezes, I guess, freezing them first, separating out the ones most likely to survive, freezing them again.

[00:21:06] Speaker 04:
So they've come up with an innovative way of selecting from the pool of all hepatocyte cells, those cells likely to be able to survive cryopreservation.

[00:21:16] Speaker 04:
Why isn't that innovative in light of the state of the art?

[00:21:19] Speaker 00:
Well, and I think what the response is there

[00:21:23] Speaker 00:
All that they are doing is identifying those cells which exhibit the natural phenomenon.

[00:21:29] Speaker 04:
Can you say all they're doing is identifying?

[00:21:31] Speaker 04:
No, no.

[00:21:31] Speaker 04:
They're actually submitting them.

[00:21:33] Speaker 04:
They're freezing them.

[00:21:34] Speaker 04:
They're thawing them, submitting them to a density gradient.

[00:21:37] Speaker 04:
Then they're separating them.

[00:21:38] Speaker 04:
Then they're freezing them again.

[00:21:40] Speaker 04:
That's what these steps are.

[00:21:41] Speaker 04:
Correct.

[00:21:41] Speaker 04:
These steps have nothing to do with identification.

[00:21:43] Speaker 04:
It has to do with a series of steps being performed and a winnowing of cells in that process.

[00:21:52] Speaker 04:
I don't see why this is an identification.

[00:21:54] Speaker 00:
Well, you are isolating the ones that exhibit the natural phenomenon of being able to survive multiple freeze-thaw cycles.

[00:22:05] Speaker 00:
So you're taking those and then freezing them, subjecting them, which is coextensive with the natural phenomenon that you're claiming.

[00:22:15] Speaker 00:
You say, I'm going to start with a group of cells

[00:22:18] Speaker 00:
some of which are capable of being frozen and thawed more than once.

[00:22:23] Speaker 04:
But if this is your argument, then nobody could ever, even the very first person to have done it, could ever get a method claim on cryopreservation of any cells.

[00:22:36] Speaker 04:
Because your argument is that your method of cryopreserving cells, even though it is a method of preservation,

[00:22:44] Speaker 04:
is not eligible for patentability because it's acting on underlying cells?

[00:22:50] Speaker 00:
If someone came up with a novel approach of cryopreserving hepatocyte cells that was providing an enhanced ability of those cells to survive through the cryopreservation techniques, here it's acknowledged that

[00:23:10] Speaker 00:
that all of the cryopreservation techniques, that you can use any of them, that they're all conventional, that they're all well understood in routine and the art.

[00:23:18] Speaker 00:
The only difference between the cryopreservation steps here and those that have been practiced for 30 years at the time is that you're applying it to cells that have the natural capability of surviving that second freeze process, which is coextensive

[00:23:36] Speaker 00:
with the natural phenomenon.

[00:23:37] Speaker 00:
It's called out expressly.

[00:23:39] Speaker 04:
Is your argument though, so suppose that I come up with the concept of cryopreservation and I really am the first to have come up with that and I cryopreserve a particular cell line.

[00:23:52] Speaker 04:
Is it really your argument then that the next scientist that realizes and has the light bulb go off, oh my goodness, not only can her cryopreservation technique work on these cells, it'll work on all these other cells as well and that

[00:24:06] Speaker 04:
he or she then patents the process of cryopreserving different cell lines, which I had not anticipated.

[00:24:14] Speaker 04:
I had not disclosed.

[00:24:15] Speaker 04:
I had not thought of.

[00:24:17] Speaker 04:
Are they really not entitled to that patent?

[00:24:19] Speaker 00:
Well, I don't think that's the case here.

[00:24:22] Speaker 00:
Yes, you could.

[00:24:23] Speaker 04:
But that is the case here, because the argument, it seemed to me, till a large extent, boiled down to whether or not it was obvious

[00:24:31] Speaker 04:
to cryopreserve the cells based on the likelihood of their survivability?

[00:24:37] Speaker 00:
Really, what was acknowledged here is that there's a certain number of these cells that's discovered that certain of these cells, and you don't know which ones they are when you start the process, have the capability of surviving multiple freeze-thaw cycles.

[00:24:52] Speaker 00:
So what do you do?

[00:24:53] Speaker 00:
You take hepatocytes that are isolated from the liver.

[00:24:56] Speaker 00:
You subject them to the first freeze, which was a conventional step.

[00:25:01] Speaker 00:
You thaw them, which was a conventional step.

[00:25:04] Speaker 00:
You perform a density gradient fractionation on them to separate out the cells that survived the first freeze thaw from those that didn't, conventional step.

[00:25:15] Speaker 00:
You can cool those, conventional step.

[00:25:18] Speaker 00:
That was being done in the ARC.

[00:25:19] Speaker 00:
People were making their own pools and then immediately going on to test them in the pharmaceutical industry.

[00:25:26] Speaker 00:
The only thing that wasn't done before was taking those cells that had been

[00:25:31] Speaker 00:
previously frozen and thawed, and then freezing them again, which is the very thing which was the discovered natural phenomenon.

[00:25:38] Speaker 04:
But this is a method claim, and you're talking about patent eligibility.

[00:25:42] Speaker 04:
I just don't understand your logic, because if these are a series of steps, every method, every series of steps in every method, each of those steps individually has been done by someone before.

[00:25:53] Speaker 04:
It's like taking a chemical composition.

[00:25:55] Speaker 04:
Every one of the elements that's added preexisted.

[00:25:58] Speaker 04:
It's the combination that is new.

[00:26:00] Speaker 04:
If this combination is new, these steps were not previously performed in this series in the past, then why isn't it patent eligible?

[00:26:11] Speaker 00:
I think the reason is because the way this claim is drafted, this claim specifically calls out the discovered natural phenomenon.

[00:26:23] Speaker 04:
You mean the wherein clause.

[00:26:26] Speaker 04:
Right?

[00:26:26] Speaker 04:
This claim could have easily stopped before the wear-in clause, where in greater than 70% survive.

[00:26:32] Speaker 04:
So if this claim is stopped before the wear-in clause, then you think it would be patent-eligible, but because it actually has the wear-in clause, you think it's not?

[00:26:39] Speaker 00:
Well, the claim itself, right in the preamble, says that it's a method of producing this preparation, said hepatocytes being capable of being frozen and thawed at least two times.

[00:26:53] Speaker 04:
That's just a method of intended purpose for these method steps.

[00:26:57] Speaker 04:
The only thing in the body of the claim, it seems to me, that goes to the natural phenomenon that you're claiming is the wear-in clause.

[00:27:03] Speaker 04:
Wear-in greater than 70% are viable after the first thaw, right?

[00:27:07] Speaker 04:
Nothing else in the body of the claim supports what you're saying.

[00:27:11] Speaker 00:
Well, in the body of the claim in step C that you're pointing to, Judge Moore, it talks about said hepatocytes.

[00:27:18] Speaker 00:
So there is express reference

[00:27:22] Speaker 00:
that the antecedent basis for the said hepatocytes is the statement in the preamble.

[00:27:28] Speaker 03:
Why isn't it the statement in part A?

[00:27:30] Speaker 04:
Yeah, in part A, subjecting hepatocytes.

[00:27:34] Speaker 04:
The said hepatocytes in C gets its antecedent basis from A, not from the preamble.

[00:27:38] Speaker 00:
I think, well, in terms of the wearing clause in reference to its ability to survive, it's coming from the capability of those claim, of those hepatocytes to survive

[00:27:50] Speaker 00:
I see I've exhausted my time.

[00:27:53] Speaker 00:
Is there more follow-up?

[00:27:57] Speaker 00:
Thank you.

[00:28:05] Speaker 01:
Just a couple of brief points, Your Honor.

[00:28:08] Speaker 01:
My colleague referred to Funk Brothers, but there, too, the Supreme Court expressly said that it wasn't dealing with a method patent.

[00:28:17] Speaker 01:
And also,

[00:28:19] Speaker 01:
relevant to the step two analysis, if the court reaches it, said that it was a simple step to mix the various naturally occurring substances.

[00:28:30] Speaker 01:
And here, as we've discussed, our contention is that the steps here are not industry standard or routine for the reasons that the court has pointed out and that I've discussed.

[00:28:43] Speaker 01:
In response to Judge Stoll's question, I think

[00:28:48] Speaker 01:
What exists in nature is individual hepatocytes from individual separate donors that have a very short lifespan.

[00:29:00] Speaker 01:
And what this method is designed to do, as Judge Moore said, is to both preserve them

[00:29:05] Speaker 01:
but also to provide a mechanism by which they can be pooled because in nature it is rare that there are multiple donors available at the same time to create initially a pooled sample.

[00:29:18] Speaker 01:
So what happens here is after the first freeze, when the

[00:29:23] Speaker 01:
they are thought, then it is possible to mix them together from different donors and have something at the end that not only is preserved, but also has this characteristic of being a group of cells from different donors.

[00:29:36] Speaker 04:
And does that have advantages?

[00:29:38] Speaker 01:
That has significant advantages for the testing process as the patent lays out.

[00:29:43] Speaker 04:
And no combination of cells from different donors would exist in nature?

[00:29:47] Speaker 04:
So even if I had a problem with your claim one argument, vis-a-vis the cells themselves and the myriad point I made, you would distinguish that claim five, on the other hand, creates a composition of cells that absolutely is not found in nature?

[00:30:03] Speaker 01:
Absolutely, Your Honor.

[00:30:04] Speaker 04:
OK.

[00:30:04] Speaker 04:
I just want to make sure I understand.

[00:30:05] Speaker 04:
Yes.

[00:30:07] Speaker 01:
Unless the court has any further questions.

[00:30:09] Speaker 01:
Thank you.

[00:30:09] Speaker 04:
We thank both counsel.

[00:30:09] Speaker 04:
The case is submitted.