[00:00:02] Speaker 05:
The next case for argument is 17-2354, Enzo Life Sciences versus Gen Pro.

[00:00:08] Speaker 05:
Mr. Wilcox, whenever you're ready.

[00:00:18] Speaker 00:
Good morning, Your Honor, and may it please the Court.

[00:00:20] Speaker 00:
Justin Wilcox, and Damaris LLP, on behalf of Appellant Enzo.

[00:00:24] Speaker 00:
The District Court committed two fundamental errors in grading summary judgment of nominating land.

[00:00:30] Speaker 00:
the district court erroneously resolved factual disputes in summary judgment.

[00:00:35] Speaker 00:
It incorrectly found that no dispute of material fact existed as to the specification did not disclose phosphate-labeled polynucleotides that would maintain hybridizability and detectability, despite the fact that defendant's experts admitted just the opposite, that any labeled polynucleotide would be hybridizable and detectable.

[00:00:56] Speaker 00:
And despite the fact that the district court in its own written description

[00:01:00] Speaker 00:
analysis found a fact dispute as to whether this classification disclosed phosphate-labeled polynucleotides that were capable of hybridization detection.

[00:01:13] Speaker 00:
On this point alone, the court should have denied summary judgment.

[00:01:17] Speaker 02:
Abbott says in the red brief that example five offers an untested labeled polynucleotide that you to this day have never confirmed remains hybridizable.

[00:01:30] Speaker 02:
and detectable.

[00:01:31] Speaker 02:
Not even your own experts saw any evidence that they did such testing.

[00:01:35] Speaker 02:
They have that in quotes.

[00:01:38] Speaker 02:
Is that true?

[00:01:41] Speaker 00:
We would disagree with Abbott's characterization.

[00:01:45] Speaker 00:
There's proof in the record that example five.

[00:01:47] Speaker 02:
So where is that record proof?

[00:01:49] Speaker 00:
Your Honor, we have the testimony of inventor Dr. Stavrianopoulos that example five taught internal phosphate labeling.

[00:01:59] Speaker 00:
That's at appendix 7006.

[00:02:00] Speaker 00:
That's cited on our reply brief at page seven.

[00:02:06] Speaker 00:
He also testified it would not be difficult to label with example five and that example five would 100% work as a hybridization probe.

[00:02:15] Speaker 00:
And that's at appendix 5298.

[00:02:18] Speaker 05:
Is that the question that the parties debated about whether this was a paper example or a working example?

[00:02:24] Speaker 05:
Because the other side cites the inventor testimony.

[00:02:27] Speaker 05:
where the inventor said, or maybe you relied on it, where he suggests that maybe he did perform it.

[00:02:34] Speaker 05:
It might have been around 1982.

[00:02:36] Speaker 05:
I don't remember that now.

[00:02:38] Speaker 05:
So the other side comes back and says, no, no, no, no.

[00:02:40] Speaker 05:
There's not enough specificity in that.

[00:02:42] Speaker 05:
Is that what we're talking about?

[00:02:43] Speaker 05:
Or is there another statement by the inventor you're talking about?

[00:02:46] Speaker 00:
Your Honor, this would be that statement.

[00:02:49] Speaker 00:
I think this shows that there is a classical fact dispute that should have precluded summary judgment.

[00:02:53] Speaker 00:
the digit coordinates written description analysis found a disputed fact as to whether... Wait, it's a disputed fact that requires a trial when the inventor comes up.

[00:03:01] Speaker 05:
You want him to say, I did a work, even assuming that the end broke out.

[00:03:06] Speaker 05:
And he says, I don't remember that.

[00:03:08] Speaker 05:
We have to have a trial.

[00:03:09] Speaker 05:
Why?

[00:03:10] Speaker 05:
To try to make him to remember that?

[00:03:12] Speaker 00:
Your Honor, we came forward with evidence and the inventor, Dr. Savonov, has testified that he used the example five chemistry to label

[00:03:21] Speaker 00:
of a phosphate label of polynucleotide probe.

[00:03:25] Speaker 00:
There is testimony to that fact from Dr. Stavrinopoulos.

[00:03:30] Speaker 00:
Now, in terms of, I think this goes to the argument that the defendants made about whether there's actual evidence of using this probe in an actual experiment.

[00:03:41] Speaker 00:
There's no evidence of that, but there is absolutely no evidence that this would not work for its intended purpose to be used as a probe.

[00:03:49] Speaker 00:
And defendants had the burden

[00:03:51] Speaker 00:
to come forward, because it's their burner proof on non-enabling, to show that some claimed embodiment would not work.

[00:03:59] Speaker 00:
But they haven't provided any evidence of that.

[00:04:01] Speaker 00:
And that's why we would say the court's second fundamental legal error was to shift the burden to ENSO to prove that these claimed inventions would work, especially absent no evidence to the contrary.

[00:04:13] Speaker 05:
So you say, I'm claiming a million probes, and the functionality of them is that they all result in

[00:04:20] Speaker 05:
I hate to say this word, hybridization and degradation.

[00:04:25] Speaker 05:
And the burden is on them to show that some of the million don't work for that.

[00:04:29] Speaker 05:
Is that your analysis of how we apply enablement?

[00:04:34] Speaker 00:
Your Honor, it's their burden, yes, to come forward if they're claiming non-enablement and show that there's some non-working embodiment.

[00:04:43] Speaker 00:
And that's been the case law.

[00:04:44] Speaker 00:
That's in the outcome of our case.

[00:04:45] Speaker 05:
Well, what have you disclosed?

[00:04:46] Speaker 05:
The question is, what have you disclosed

[00:04:49] Speaker 05:
in the specification to support the fact that you've enabled the hybridization and degradation of millions of probes.

[00:04:59] Speaker 02:
Yeah, and let me add to that, because it's the same question.

[00:05:04] Speaker 02:
At 42 and 43 of the RedBerry, Abbott says, it's undisputed that the specification nowhere discloses how to achieve those properties for any, much less every combination of label linker and labeling position.

[00:05:17] Speaker 02:
nor guidance on which combinations are likely to have those features.

[00:05:22] Speaker 00:
Your Honor, that's what was quoted.

[00:05:24] Speaker 00:
I would first say that one, the defense didn't come forward with any specific examples.

[00:05:28] Speaker 00:
If this was so obvious that something wouldn't work, they should have come forward with an example of non-working embodiment.

[00:05:35] Speaker 00:
But the test on enablement is whether a skilled artist could make and use the claim to mention.

[00:05:41] Speaker 02:
Where in the record does the specification show how to achieve what they're talking about in the red brief?

[00:05:47] Speaker 00:
Your Honor, first, the specification discloses in example five a specific chemistry for labeling any RNA or DNA sequence with any of the labels that are identified in the patent.

[00:06:01] Speaker 00:
That's the first thing.

[00:06:02] Speaker 00:
So that teaches a skilled artisan how to create the claimed phosphate-labeled polynucleotide.

[00:06:09] Speaker 00:
Then an artisan would look at the remainder of the specification, and in particular, column 54,

[00:06:16] Speaker 00:
18 through 45, where there's a discussion of how to also other design considerations, like the length, the number of nucleotides, that it's preferably 12 nucleotides would be possible to identify any disease date.

[00:06:33] Speaker 00:
And then we take that along with the specification that talks about the use of these probes for hybridization.

[00:06:39] Speaker 00:
At this point in 1982, hybridization was well known.

[00:06:44] Speaker 00:
Skilled artisans have been doing hybridization for years.

[00:06:47] Speaker 00:
In the patent in column 17, it talks about the northern and the southern hybridization techniques.

[00:06:55] Speaker 00:
It talks about in situ hybridization techniques.

[00:06:58] Speaker 00:
So fundamentally, what the defendants argued, what the district court did was really shrink down the frame of reference just to these phosphate labeled polynucleotides, which are the claimed event of improvement in saying, well, you have to ignore

[00:07:14] Speaker 00:
all of the other understanding and the art up until that time, which was just wrong.

[00:07:19] Speaker 00:
Because once the technology and the understanding is taught about how to make these probes, then the use of the probes in standard hybridization.

[00:07:29] Speaker 05:
When you say make these probes, what are you talking about?

[00:07:32] Speaker 05:
Are you talking about the functionality that you've claimed here, which I guess makes this an invention versus a non-invention, which is we're doing these and they achieve hybridization and detection?

[00:07:44] Speaker 05:
That wasn't known in the art, right?

[00:07:46] Speaker 00:
Your Honor.

[00:07:48] Speaker 05:
Can you just answer my question first, and then you can explain it?

[00:07:50] Speaker 00:
Yes, Your Honor.

[00:07:51] Speaker 00:
The invention here was the phosphate labeling of the probe and the use of this phosphate labeled probe to be able to be detectable after hybridization.

[00:08:01] Speaker 00:
Those are the claimed inventions.

[00:08:03] Speaker 00:
And that wasn't known in the art?

[00:08:05] Speaker 00:
That was not known in the art.

[00:08:07] Speaker 00:
OK.

[00:08:07] Speaker 00:
So we come forward with example five that teaches the precise chemistry for attaching a label

[00:08:14] Speaker 01:
to the phosphate.

[00:08:16] Speaker 01:
Does it teach where in the base the attachment is to occur?

[00:08:20] Speaker 00:
Yes, it does.

[00:08:21] Speaker 00:
It does, Your Honor.

[00:08:22] Speaker 00:
If we turn to column 54, 18 through 45.

[00:08:29] Speaker 01:
What's the page number of the appendix?

[00:08:36] Speaker 00:
That would be appendix 456, Your Honor.

[00:08:39] Speaker 05:
We're turning up the 180 here, right?

[00:08:41] Speaker 00:
Correct, Your Honor.

[00:08:45] Speaker 00:
First, in that section, this gives guidance on.

[00:08:49] Speaker 05:
I'm sorry, can you tell us where we're looking again?

[00:08:52] Speaker 05:
I lost track.

[00:08:53] Speaker 00:
So that would be appendix site 456.

[00:08:56] Speaker 00:
Yes, which column?

[00:08:57] Speaker 00:
And that would be column 54, lines 18 through 45.

[00:09:03] Speaker 00:
And that passage right there, first of all, it teaches how to pick a sequence.

[00:09:08] Speaker 00:
I mean, that was already probe 101 that one would pick a sequence complementary to the type of disease date sequence you're trying to locate.

[00:09:15] Speaker 00:
But it teaches that specifically right there.

[00:09:18] Speaker 00:
Then it goes on to discuss how to decide the length.

[00:09:21] Speaker 00:
It recommends a length of between 5 and 500 nucleotides.

[00:09:24] Speaker 00:
It also teaches that, quote, 12 matching, preferably consecutive, nucleotide units would be sufficient to affect identification of most DNA or RNA material to be investigator identified.

[00:09:36] Speaker 02:
Would you agree that the claims require attaching a label without interfering with the polynucleotides ability to hybridize or the labels

[00:09:46] Speaker 02:
detectability upon hybridization.

[00:09:49] Speaker 00:
That's correct, Your Honor.

[00:09:51] Speaker 02:
OK.

[00:09:52] Speaker 02:
And that's the preceding sentence to what I read you before, which is, it's undisputed that the specification nowhere discloses how to achieve those properties for any much less every combination of label.

[00:10:07] Speaker 02:
Where does it do that?

[00:10:09] Speaker 00:
Your Honor, the chemistry in example five teaches skilled artisan

[00:10:14] Speaker 00:
how to phosphate label

[00:10:35] Speaker 00:
are what come together with another sequence to bind.

[00:10:38] Speaker 00:
So the labeling on the phosphate is outside of these.

[00:10:40] Speaker 05:
But even if a person skilled in the art could create this full range of structures covered by the claim, where's the guarantee that each of the structures would be hybridizable and detectable?

[00:10:53] Speaker 00:
Yes, Your Honor.

[00:10:54] Speaker 00:
See, that's the issue here.

[00:10:56] Speaker 00:
The test of enablement is not to guarantee that every embodiment works or that the claimed invention would work.

[00:11:03] Speaker 02:
Or any embodiment.

[00:11:04] Speaker 00:
So pardon me, Your Honor, let me rephrase.

[00:11:06] Speaker 00:
The test is not to guarantee that the claim eventually work.

[00:11:09] Speaker 00:
And the courts recited that in the Alcom V. Bar case.

[00:11:12] Speaker 00:
What it's doing here is it's supposed to teach one to make and use without undue experimentation.

[00:11:18] Speaker 00:
So we have the chemistry.

[00:11:19] Speaker 00:
Well, to make and use in a way that works.

[00:11:21] Speaker 00:
Make and use in a way that works.

[00:11:22] Speaker 01:
Yes, Your Honor.

[00:11:22] Speaker 01:
And the full scope of the claim, too.

[00:11:24] Speaker 00:
Yes, Your Honor.

[00:11:25] Speaker 00:
And so we have the full scope of making, through example five, being able to label any RNA or DNA sequence along with any label that's described here.

[00:11:34] Speaker 00:
And then the hybridizability aspect, one would use these in typical hybridization experiments as it's laid out in the specification.

[00:11:44] Speaker 05:
And maybe they'll work for their intended purpose, and maybe they won't?

[00:11:47] Speaker 00:
Well, Your Honor, I think that's the problem.

[00:11:48] Speaker 05:
And it's up to them then to show that they don't out of these millions of probes?

[00:11:52] Speaker 00:
Your Honor, well, I think that's part of the skepticism here.

[00:11:55] Speaker 00:
Anytime there's always skepticism about the utility

[00:11:59] Speaker 00:
of some kind of new improvement.

[00:12:02] Speaker 00:
And here, it's undisputed there is skepticism about labeling outside of certain base positions that that would even work.

[00:12:09] Speaker 00:
But the test enablement is not to dispel this skepticism.

[00:12:14] Speaker 00:
It's to teach one to make and use.

[00:12:16] Speaker 00:
And there's no evidence in the record that using example five and running a hybridization assay, that any claim to embodiment would not work.

[00:12:24] Speaker 00:
And I think that's the fundamental issue here.

[00:12:26] Speaker 00:
We've set forth

[00:12:28] Speaker 00:
disclosure of the specification, how to make, how to use.

[00:12:32] Speaker 00:
And then the district court then went on to say, well, we would have to prove that a vast number of these embodiments.

[00:12:39] Speaker 05:
OK, we're into rebuttal, so I want to hear from the other side.

[00:12:41] Speaker 05:
Thank you.

[00:12:44] Speaker 05:
Now, you're dividing your argument?

[00:12:47] Speaker 05:
Yes, Your Honor.

[00:12:48] Speaker 05:
Is there a method to this?

[00:12:49] Speaker 05:
I mean, are you arguing one thing and your friend the other?

[00:12:52] Speaker 03:
Yes, Your Honor, there's a little rhyme and reason.

[00:12:54] Speaker 03:
Matthew Wolf, for the non-abict defendants, I'm going to argue,

[00:12:58] Speaker 03:
Enablement of the 180 patent, which we were just discussing.

[00:13:00] Speaker 03:
And also, if your honors are interested, the indefiniteness issues related to the 180.

[00:13:05] Speaker 03:
And then my friend will argue written description and then the 405 issues to the extent there are questions about that.

[00:13:13] Speaker 05:
Can you start with what your friend ended with, which was what the test is for enablement and who's got the burden to show what?

[00:13:20] Speaker 05:
Do you agree with his assessment of that?

[00:13:23] Speaker 03:
I don't, your honor.

[00:13:24] Speaker 03:
The point of enablement, of course, as Judge Raina suggested,

[00:13:28] Speaker 03:
Have you established that you have instructed, educated those of skill in the art to make and use the full scope of the invention?

[00:13:36] Speaker 03:
At best, example five teaches you how to make one part of one species of one example of the invention.

[00:13:46] Speaker 03:
Talking, Your Honor, Judge Wallach, you asked about what was admitted or stated regarding example five.

[00:13:51] Speaker 03:
Dr. Stavronopoulos, the same inventor.

[00:13:55] Speaker 02:
Yeah, you say that his statement is entirely Ipsi-Dixit.

[00:14:00] Speaker 03:
It's worse than that because it was directly contradicts what was sworn to the Patent Office in 1987.

[00:14:05] Speaker 03:
This is at A4703 where they said, quote, it was determined that it was a paper rather than working example.

[00:14:12] Speaker 03:
And they go so far as to apologize that the language suggests it was actually performed.

[00:14:17] Speaker 03:
They call it, quote, an inadvertent misstatement.

[00:14:19] Speaker 03:
This is, again,

[00:14:20] Speaker 03:
A4703.

[00:14:21] Speaker 03:
But even with all that, Dr. Stavronopoulos saying, I have some vague recollection.

[00:14:26] Speaker 03:
I might have done this in 82.

[00:14:27] Speaker 03:
He then said, well, yes, but quote, we never make a probe out of it.

[00:14:31] Speaker 03:
That's an A5293.

[00:14:33] Speaker 03:
So even if you accept that they did something with the Halloran chemistry, that's the article, the 1966 article that somehow has become the bedrock of this entire invention, was this 25-year-old chemistry.

[00:14:45] Speaker 03:
Even if you accept they did something with it, their own inventor, the linchpin of their

[00:14:49] Speaker 03:
There must be a fact issue here.

[00:14:51] Speaker 03:
Argument says, we never made a probe out of it, let alone figure out whether it's hybridizable or detectable when hybridized, let alone actually disclose it within the four corners of the patent, which is, of course, the test.

[00:15:03] Speaker 03:
And in fact, there's an interesting shift that occurred here.

[00:15:06] Speaker 03:
At the district court below, the bulk of the argument, the gist, any fair reading of what they said is, the one of ordinary skill would know how to do that.

[00:15:14] Speaker 03:
And Judge Stark threw up his hands and said, that's not the test.

[00:15:17] Speaker 03:
The test is, did you teach it?

[00:15:19] Speaker 03:
Now they've shifted gears on appeal and said, well, it's really all about example five.

[00:15:23] Speaker 03:
But example five, as I said, at best teaches a small part of one species of making the probe.

[00:15:31] Speaker 03:
And there's really three things that have to happen here for it to be enabled.

[00:15:34] Speaker 03:
First, they have to make a probe.

[00:15:36] Speaker 03:
Then they have to figure out whether it's hybridizable.

[00:15:38] Speaker 03:
Then they have to figure out whether it's detected when it's hybridized.

[00:15:41] Speaker 03:
And I don't want to belabor this, but Dr. Klein, one of the inventors, admitted at 84249 and 6494

[00:15:48] Speaker 03:
that individual experiments need to see if the label or the linker impacts hybridization.

[00:15:56] Speaker 03:
We were pointed to a specific paragraph in the patent.

[00:15:59] Speaker 03:
That didn't say anything about what linkers would work and what that would mean for hybridization detection.

[00:16:03] Speaker 03:
Well, I asked that question repeatedly.

[00:16:06] Speaker 03:
Yeah.

[00:16:06] Speaker 03:
And certainly didn't say which of the hundreds of, I mean, I think the admission is hundreds of thousands of potential labels alone.

[00:16:13] Speaker 03:
That's what Dr. Klein said.

[00:16:15] Speaker 03:
And they admitted that some labels do or do not get detected.

[00:16:21] Speaker 03:
Some labels do or do not interfere with hybridization.

[00:16:25] Speaker 03:
And that requires, quote, case-by-case experimentation.

[00:16:28] Speaker 01:
This is a good point for me to ask this particular question, because I think you said you were also going to address indefinite.

[00:16:34] Speaker 01:
Yes, Your Honor.

[00:16:35] Speaker 01:
All right.

[00:16:35] Speaker 01:
So it seems to me that what these patents cover, it recognizes the word patents.

[00:16:42] Speaker 01:
Yes, Your Honor.

[00:16:43] Speaker 01:
And it seems to me that in some way, the pens say, and we cover everything else.

[00:16:48] Speaker 03:
Yes, Your Honor, that's exactly right.

[00:16:51] Speaker 03:
So Dr. Ward spent, his colleagues at Yale spent eight years, six in the lab, eight years overall.

[00:16:57] Speaker 01:
And why is that?

[00:16:58] Speaker 01:
Is it because the pens don't teach where the attachment to the basis to occur?

[00:17:03] Speaker 03:
The Ward patents, the ones that were incorporated wholesale are the 30 columns of Warden.

[00:17:08] Speaker 03:
And Dr. Ward got his own patents on what are called the Ward positions now.

[00:17:11] Speaker 03:
I mean, this is legendary chemistry he did.

[00:17:14] Speaker 03:
But Dr. Ward figured out three specific places with three specific labels out of everything else that would actually work on the base.

[00:17:23] Speaker 03:
And then Enzo took a license to that.

[00:17:26] Speaker 03:
And this is admitted, and this is in the record.

[00:17:27] Speaker 03:
And they said, well, we're concerned that people are going to design around this.

[00:17:31] Speaker 03:
And it's hard work.

[00:17:33] Speaker 03:
So we're going to just do a paper patent that says everything else, everywhere else on the bases, everywhere on the phosphate moiety, everywhere on the sugar moiety.

[00:17:42] Speaker 03:
We're just going to claim that.

[00:17:44] Speaker 01:
Does it really say that everywhere else on any part of the bases?

[00:17:48] Speaker 01:
Or is there a failure to state where on the base the attachedness occurred in order to be able to hybridize?

[00:17:54] Speaker 03:
Yes, Your Honor, it is conceded.

[00:17:56] Speaker 03:
These particular patents, the 180 patent is dealing with the phosphate moiety.

[00:18:00] Speaker 03:
My colleague will talk about other positions that are relevant uniquely to his client.

[00:18:06] Speaker 03:
But this particular patent is, at least the claims at issue are, attached anything to the phosphate.

[00:18:12] Speaker 03:
Remember, Dr. Ward spent years trying to figure out how to do the base.

[00:18:15] Speaker 03:
We're going to do the phosphate.

[00:18:17] Speaker 03:
And the state of the art at the time, I think this is undisputed.

[00:18:20] Speaker 03:
It was a holy molecule.

[00:18:22] Speaker 03:
This is Dr. Rabbani, the CEO.

[00:18:25] Speaker 03:
They thought anything you did to modify it

[00:18:29] Speaker 03:
would risk retaining its attributes.

[00:18:31] Speaker 03:
It was, quote, dogma that phosphate labeling would be disruptive to how it behaved.

[00:18:36] Speaker 03:
That's an A6465.

[00:18:38] Speaker 03:
So to this day, I mean, Dr. Stavronopoulos acknowledged, to this day, it's hard to label phosphates.

[00:18:46] Speaker 03:
Another fight we had at the district court that did not go well for plaintiffs was internal versus terminal phosphate labeling.

[00:18:58] Speaker 03:
nucleotide-long polynucleotide.

[00:19:00] Speaker 03:
There are two terminal phosphates.

[00:19:03] Speaker 03:
Halorin, example five, says here's how you can label at the ends, and he wasn't even talking about labeling, he was talking about tying to a protein, but here's the chemistry to attach something to the ends.

[00:19:14] Speaker 03:
There's nothing about the 99 internal phosphates, and that's where the admission is that when you get to internal phosphates, that's what disrupts hybridization.

[00:19:23] Speaker 03:
That's what causes hydrolysis,

[00:19:25] Speaker 03:
They said at the time you couldn't even synthetically make more than 15 of these, yet they claim up to 100,000.

[00:19:31] Speaker 03:
I'm belaboring this and the horse is being beaten, but I'm not sure, unless there are any other questions, I'll give Mr. Quinn my time.

[00:19:38] Speaker 03:
Do you want to say a word?

[00:19:39] Speaker 05:
I thought you were going to ask about indefiniteness.

[00:19:41] Speaker 03:
I did.

[00:19:41] Speaker 03:
Okay.

[00:19:42] Speaker 03:
With that, Your Honors, unless there's anything else, I'll turn it over to Mr. Quinn.

[00:19:45] Speaker 03:
Thank you.

[00:19:52] Speaker 04:
Thank you, Chief Judge Prost.

[00:19:54] Speaker 04:
May I please the court, John O'Quinn, on behalf of Abbott.

[00:19:57] Speaker 04:
Judge Raina, the point that you made a moment ago, the Ward patent claims a specific label on three of the base positions.

[00:20:06] Speaker 04:
In the 405 patent, they attempt to claim everything else, every other position, every other base position, every sugar position, every phosphate position, whether it's a monophosphate, a diphosphate, a triphosphate,

[00:20:20] Speaker 04:
And they try to claim it all without ever doing a single test to show hybridization and detectability.

[00:20:28] Speaker 04:
And that's conceded by their experts at appendix 6441, 8468, 8552.

[00:20:33] Speaker 04:
And the only testing that my friend referred to was the suggestion by Dr. Stavrianopoulos, one of the inventors, that they may have labeled

[00:20:47] Speaker 04:
back in 1982 using example five, but as my colleague Mr. Wolf pointed out, there's no evidence that beyond labeling with example five, they actually did any testing of example five.

[00:21:00] Speaker 04:
These patents are the epitome of attempting to preempt the future before it arrives.

[00:21:08] Speaker 04:
At most, they both disclosed that some combination of labels, linkers, location, and nucleotides

[00:21:16] Speaker 04:
might be able to be used as a probe that would both hybridize and remain detectable, but nothing in the patents told a skilled artisan in 1982 which ones would and which ones wouldn't, much less how to determine that except through trial and error.

[00:21:34] Speaker 04:
And that is why this case is very analogous to Wythe, because as the inventors and both of Enzo's experts ultimately admit,

[00:21:44] Speaker 04:
you couldn't know ahead of time whether a particular labeled polyonucleotide would actually be hybridizable and detectable.

[00:21:52] Speaker 04:
For example, Dr. Sherman, one of ENSO's experts with respect to the 405 patent, at appendix 8455 said, quote, for any given probe labeled at a non-ward position with any particular linker or label, one skilled in the art would need to make

[00:22:10] Speaker 04:
and test it to be able to predict whether it would actually hybridize."

[00:22:14] Speaker 04:
He said there was no ability to predict.

[00:22:17] Speaker 04:
One of the inventors, Dr. Klein, said the same thing.

[00:22:20] Speaker 04:
Dr. Backman, one of their experts at Appendix 6451,

[00:22:26] Speaker 04:
said you could not, quote, predetermine which label would significantly affect the hybridization property.

[00:22:32] Speaker 04:
And that was for labeling at the phosphates.

[00:22:33] Speaker 04:
Of course, the 180 pattern only involves.

[00:22:35] Speaker 05:
But of course, that doesn't answer the question that your friend posed, which the question before us is whether or not there's enough of a factual dispute to get us to trial.

[00:22:45] Speaker 05:
Sure.

[00:22:46] Speaker 05:
So all of what you said is maybe correct, but kind of conclusory.

[00:22:50] Speaker 05:
So what do you say to the arguments your friend makes with regard to

[00:22:54] Speaker 05:
at least being a factual dispute.

[00:22:56] Speaker 04:
Well, I think, Chief Judge Prost, there's not any factual dispute that there's no evidence of any testing whatsoever with respect to hybridization and detectability.

[00:23:06] Speaker 04:
There is nothing in the patent itself that will teach a person of ordinary skill in the art how to make one of these and know that it will be hybridizable and detectable.

[00:23:18] Speaker 04:
It's not enough to teach, and we dispute that they do this, but it's not enough to teach labeling

[00:23:23] Speaker 04:
You've got to teach labeling of a polynucleotide that will hybridize and be detectable.

[00:23:29] Speaker 04:
And when every single expert, and this is what I was just, the list that I was rattling off, and there are more.

[00:23:34] Speaker 04:
I mean, Dr. Waldrop, for example, who was part of the word group, he said, quote, we're doing the groundbreaking work of figuring out what does and doesn't work, and it's trial and error.

[00:23:43] Speaker 04:
That's appendix 6509.

[00:23:45] Speaker 04:
When every single inventor, when ENSO's consultants, when ENSO's experts tell you that the only way to know is to make it and then test it, then

[00:23:53] Speaker 04:
That falls in the heartland of this Court's decision in Wyeth, because it is undisputed.

[00:23:58] Speaker 04:
There are millions of possibilities here.

[00:24:00] Speaker 04:
I mean, there are thousands of fluorescent labels alone, and you would have to go through, in order to know whether or not it would actually be hybridizable and detectable, you'd have to go through and test it.

[00:24:11] Speaker 04:
And that is the epitome of undue experimentation, both under the Wands Factors and under this Court's decision

[00:24:19] Speaker 04:
in Weiss, and I think this court's decision, and also, of course, Weiss was decided on summary judgment because precisely because there were no facts that were relevant.

[00:24:30] Speaker 04:
I mean, sure, I don't agree that there is actually a dispute vis-a-vis labeling, but even if you assume that there were, that's not enough for them in order to create a material issue of fact with respect to whether or not these patents are actually enabled.

[00:24:49] Speaker 04:
If the court has no further questions.

[00:24:51] Speaker 04:
Thank you.

[00:24:51] Speaker 04:
Thank you, Chief Judge Kroest.

[00:25:00] Speaker 00:
Your Honor, what sets this case apart from all the other non-enabling decisions that the defendants rely on and that shows that there is, in fact, dispute is that Abbott's own expert testified

[00:25:12] Speaker 00:
Quote, is it your opinion in connection with your analysis of invalidity in this case that disclosure of a non-radioactively labeled oligonucleotide inherently discloses a non-radioactively labeled oligonucleotide that is detectable and hybridized?

[00:25:28] Speaker 00:
Answer, yes.

[00:25:29] Speaker 00:
And that's on appendix 12138 through 139.

[00:25:34] Speaker 00:
We've cited that in our opposition brief at 26 and 51, pardon me, our opening brief, and our reply brief at 6.

[00:25:40] Speaker 00:
Now right here,

[00:25:41] Speaker 00:
That expert is essentially admitting just the opposite of what the court found, that any labeled polynucleotide would be hybridizable and detectable.

[00:25:51] Speaker 00:
So that's completely contrary to what the defendants are arguing here, that nobody would know that this would work.

[00:25:57] Speaker 00:
This is their expert's testimony of what would be known in the art at the time of the invention.

[00:26:04] Speaker 00:
Just moving on to address some of the alleged evidence of inoperability that my friends talked about.

[00:26:11] Speaker 00:
Those quotes from Dr. Klein, the quotes from Dr. Sherman, those are all relating to base labeling.

[00:26:17] Speaker 00:
Base labeling is involved in the claims of the 405 patent.

[00:26:21] Speaker 00:
It's not involved in the claims of the 180 patent.

[00:26:25] Speaker 00:
So there's no actual evidence of any inoperability.

[00:26:28] Speaker 00:
The defendants have come forward.

[00:26:29] Speaker 00:
They haven't been able to point to any.

[00:26:31] Speaker 00:
And even if there were, there would still be a disputed issue of fact.

[00:26:36] Speaker 00:
But I think what the argument is boiled down to is this issue of skepticism

[00:26:40] Speaker 00:
And I think that they're mistaking skepticism in the art about whether this would work versus predictability.

[00:26:46] Speaker 00:
There was predictability in the art.

[00:26:48] Speaker 00:
Artisans knew how to make hybridizable sequences.

[00:26:52] Speaker 00:
They knew the basic concepts of Watson Creek baseball that had been around since the 1950s.

[00:26:57] Speaker 00:
Overall, there's no requirement in this court's enablement precedent to require somebody to convince a skeptical artisan that the claim dimensions would work.

[00:27:07] Speaker 00:
The artisan's supposed to come forward

[00:27:09] Speaker 00:
with their knowledge of the art and take at face value what's in the patent.

[00:27:12] Speaker 00:
And if we look at that, we take at face value what's in the patent.

[00:27:15] Speaker 00:
We teach how to make a newable number of phosphate-labeled polynucleotides with example five.

[00:27:22] Speaker 00:
We teach how they're supposed to be used in hybridization assays.

[00:27:26] Speaker 00:
Now, this court addressed some similar skepticism in the Allergan v. Sanders case, where the defendant argued that a skilled artist would not accept, quote, without doubt

[00:27:36] Speaker 00:
the asserted utility of the claimed invention without efficacy data.

[00:27:40] Speaker 00:
But the court rejected that argument.

[00:27:42] Speaker 00:
This court said a patent does not need to guarantee the invention works, that efficacy data is generally not required.

[00:27:48] Speaker 00:
So here, Your Honor, we have a case where, in the face of no actual proof that any claim embodiment would work, the district court shifted the burden to ENSO to prove that the claim inventions would work, which is a fundamental error, and also resolved material fact disputes.

[00:28:06] Speaker 00:
against end zone summary judgment, which is contrary to summary judgment principles.

[00:28:11] Speaker 05:
Thank you.

[00:28:11] Speaker 05:
We thank both sides and the case is submitted.

[00:28:14] Speaker 05:
That concludes our proceeding for this month.

[00:28:16] Speaker 03:
All rise.

[00:28:17] Speaker 03:
The Honorable Court is adjourned until tomorrow morning at 10 o'clock AM.