[00:00:00] Speaker 04:
Our last case this morning is Siegen versus Daiichi in AstraZeneca, 2024, 1878.

[00:00:07] Speaker 04:
Ms.

[00:00:08] Speaker 04:
Horton.

[00:00:13] Speaker 04:
You're on the other side this time.

[00:00:17] Speaker 00:
Change tables.

[00:00:18] Speaker 00:
Good morning again, Your Honors.

[00:00:19] Speaker 00:
May it please the Court, Ms.

[00:00:21] Speaker 00:
Sarah Horton, for appellant and with me again are Mr. Stiles and Mr. Edwards.

[00:00:26] Speaker 00:
First, the board should never have reached the merits of EPOLE's petition because the 039 is not eligible for PGR.

[00:00:33] Speaker 00:
The 039 patent claims priority and shares a specification with pre-AIA application from 2004.

[00:00:40] Speaker 00:
During the prosecution, the examiner identified it as a pre-AIA patent and applied pre-AIA standards.

[00:00:48] Speaker 00:
But Congress only made post-AIA patents eligible for PGR.

[00:00:52] Speaker 00:
The legislative history is clear.

[00:00:54] Speaker 00:
Transitioned patents like the 039 that add new matter are not subject to PGR.

[00:01:02] Speaker 00:
Second, the final written description here, which came nearly three years after the petition was actually submitted by Appellees, and ten months after, the jury verdict applied the wrong legal standards on enablement and written description, which was tied up exclusively with priority.

[00:01:21] Speaker 00:
In order to find a lack of enablement, the board wrongly construed the claims to impose an efficacy requirement where none existed.

[00:01:28] Speaker 00:
And this court has repeatedly rejected such constructions.

[00:01:32] Speaker 00:
The board also improperly applied the Wands Factors by ignoring Siegen's state of the art evidence, which showed that those of skill in the art would use the claimed ADCs without undue experimentation.

[00:01:44] Speaker 00:
With regard to written description and priority, the board misstated the law.

[00:01:49] Speaker 00:
The test is not whether the written description would, quote, allow a person of skill to inherently, necessarily, or immediately envisage a tetrapeptide with only glycine or phenylalanine amino acids.

[00:02:03] Speaker 00:
That is not the standard.

[00:02:05] Speaker 00:
That is what the final written decision stated.

[00:02:08] Speaker 05:
Instead, the question...

[00:02:10] Speaker 05:
Did the board say that in the context of responding or analyzing Dr. Pertosi's statements?

[00:02:19] Speaker 05:
Yes, Your Honor, the board said that after it had gone through a description of... I don't know if two wrongs make a right here, but my understanding of what the board was saying about Dr. Pertosi was Dr. Pertosi was

[00:02:33] Speaker 05:
talking about modifying what was in the disclosure to reach a species that would be covered by the claims.

[00:02:43] Speaker 05:
And the board was trying to say, that's not the correct way to think about a written description analysis.

[00:02:53] Speaker 05:
And there wasn't anything in Dr. Potosi's presentation that really communicated that she believed that the inventor had, in fact, disclosed any compound that fits within the claim, let alone the entire subgenus.

[00:03:13] Speaker 00:
Well, Your Honor, I think that

[00:03:16] Speaker 00:
Regardless of where that statement fell, it is a heightened view of what written description requires.

[00:03:22] Speaker 00:
Written description requires here, according to the case law and area, that the application reasonably convey to one of ordinary skill in the art that the inventors possessed the claimed invention and not that they had to inherently necessarily or immediately envision it.

[00:03:39] Speaker 00:
The board was reviewing her testimony, Dr. Bertozzi's testimony, or the evidence presented through the lens of inherently, necessarily, or immediately envisioned.

[00:03:49] Speaker 00:
Then that is error and was requiring more of a description.

[00:03:54] Speaker 04:
Chemistry is a precise science.

[00:03:57] Speaker 04:
If we're talking about describing a chemical, that test isn't met by describing something else and saying, well, we've reasonably disclosed it.

[00:04:14] Speaker 00:
I think, Your Honor, that the test is that the application would reasonably convey to one of ordinary skill in the art that there was possession.

[00:04:23] Speaker 00:
And with regard to the actual... I won't be passing you what I asked you earlier.

[00:04:31] Speaker 00:
Okay.

[00:04:32] Speaker 00:
So the specification here does, as I was speaking earlier, does specify the general chemical formula.

[00:04:40] Speaker 00:
Does it specify the peptide link or maybe a tetrapeptide?

[00:04:44] Speaker 00:
does disclose glycine and phenylalanine as two of the 39 amino acids that could be used in the tetrapeptide linker.

[00:04:52] Speaker 00:
Dr. Botozzi explained the specification would have pointed the person of ordinary skill in the art to a glycine-phenylalanine-only tetrapeptide at appendix 12-12-004-2006.

[00:05:08] Speaker 00:
Setting aside the heightened and erroneous inherently necessarily or immediately envisioned legal standard used by the board to view the evidence, Appley failed to show that the disclosure did not reasonably convey to a person of ordinary skill in the art that the inventors had possession of the claimed subject matter.

[00:05:26] Speaker 00:
Appellees argue that seigen inventors had not made or tested the ADCs with a glycine or phenylalanine tetrapeptide prior to the filing, and that there are no working examples.

[00:05:38] Speaker 00:
But, of course, neither of those are required to satisfy the written description, as we've seen in this report.

[00:05:45] Speaker 00:
A case law in the Allergan case and in the Union Oil case, Allergan, in fact, states that no rigid requirement, that the disclosure contained either examples or reduction to practice.

[00:05:59] Speaker 05:
So then blaze marks are needed.

[00:06:01] Speaker 00:
Excuse me?

[00:06:01] Speaker 05:
So then blaze marks are needed.

[00:06:03] Speaker 00:
Correct.

[00:06:04] Speaker 00:
And there was evidence of blaze marks from Dr. Bertozzi, which the court declined to credit based on its-

[00:06:13] Speaker 05:
A21 quotes Dr. Bertosi in a block quote.

[00:06:21] Speaker 05:
And the last sentence of that block quote says, the patent's disclosure would have motivated the POSA to re-evaluate art that used tetrapeptide motifs, such as glyphi-lu-gly, including the use of such motifs in drug drugs, which is where glyphi-lu-gly first appeared in the literature.

[00:06:43] Speaker 05:
To me, that reads like Dr. Bertozzi relying on a motivation to modify GFLG to make GFFG.

[00:07:00] Speaker 00:
So, Your Honor, I think there where the board was... What was she getting at when she used the word motivated?

[00:07:06] Speaker 00:
I think what she's getting at is that she opined that the glyphi-only tetrapeptides were included within the scope of the disclosure and that the patent contained blaze marks pointing to that embodiment, and the post would understand that the Siegen inventors possessed that claim at the time of filing.

[00:07:25] Speaker 00:
She discussed at

[00:07:27] Speaker 00:
Apex 1212062 that the 039 patent and its priority non-provisional applications all include within their disclosures a description of a tetrapeptide that consists of amino acids with R19 groups of either hydrogen, glycine, or benzyl phenylalanine.

[00:07:49] Speaker 00:
She further discussed at 1212065 that the specifications description

[00:07:56] Speaker 00:
of the amino acid units plainly includes the tetrapeptides consisting of glycine or phenylalanine as part of the invention.

[00:08:04] Speaker 00:
She further discussed at 12066 that APOSA would have understood, therefore, that the invention included these ADCs with the glyphi-only tetrapeptides.

[00:08:16] Speaker 00:
The court did not substantively grapple with that testimony, and instead the board used this heightened legal standard to view it

[00:08:25] Speaker 00:
which we think was inappropriate and error by the board.

[00:08:30] Speaker 03:
What do we do with the interplay between this case and the district court case?

[00:08:36] Speaker 03:
We have different decisions involving the same claims.

[00:08:40] Speaker 03:
What should we do about that?

[00:08:42] Speaker 00:
Well, of course, our view is that the PGR never should have been instituted.

[00:08:48] Speaker 00:
and that the PGR of a transitional patent where no new matter is added was inappropriate, and there that the court should remand the PGR with instructions to dismiss it because there was never standing to hear it in the first place.

[00:09:06] Speaker 00:
Of course, the jury verdict is on a different standard here, right?

[00:09:10] Speaker 00:
The jury verdict,

[00:09:12] Speaker 00:
our issues of substantial evidence and whether or not the jury heard evidence that would allow it to come to the verdict that it did.

[00:09:20] Speaker 03:
And of course, in our papers, and as I was talking about earlier, we think that- We're not, by necessity, facing a moot issue.

[00:09:32] Speaker 00:
A moot issue?

[00:09:33] Speaker 03:
Yes.

[00:09:34] Speaker 03:
Does one render the other one moot?

[00:09:38] Speaker 00:
I'm sorry, I didn't hear the last question.

[00:09:39] Speaker 03:
Does one of the cases render the other case moot, the board decision?

[00:09:44] Speaker 00:
I think a little bit of that, Your Honor, depends on timing.

[00:09:48] Speaker 00:
So the jury verdict occurred 10 months before the final written decision in the PGR.

[00:09:57] Speaker 00:
And these cases are here today as companion appeals, so we are arguing them here today together.

[00:10:05] Speaker 00:
So if the timing is such that, for example, the... If I could just follow up.

[00:10:11] Speaker 05:
If we were to reverse the district court appeal, finding the patent invalid for some reason, then would that moot this PGR appeal?

[00:10:22] Speaker 05:
And likewise, if we were to affirm the PGR appeal, would that moot the district court appeal?

[00:10:32] Speaker 00:
I'm not sure about the exact terminology moot, but I will tell you that if this court were to reverse and hold the patent invalid in the jury verdict in the Texas appeal that came first, which, of course, we would disagree with, if that happened, there would be no judgment to collect and no judgment going forward, subject to other appeal rights, of course, such that the outcome of the PGR appeal

[00:11:01] Speaker 00:
might not matter.

[00:11:03] Speaker 00:
Conversely, if this court, for example, affirmed the PGR appeal, then depending on the timing of that, that might have an impact on the district court appeal as well, even if this court affirmed the district court appeal.

[00:11:23] Speaker 00:
Does that make sense?

[00:11:24] Speaker 00:
I'm trying to figure out if I've answered your moot question.

[00:11:26] Speaker 05:
I guess the question is, would this court need to even do anything with the second case?

[00:11:34] Speaker 05:
I mean, the patent would, in effect, be gone.

[00:11:37] Speaker 05:
And so therefore, there's no need for this court to go further and write a second opinion on the merits for the second appeal.

[00:11:45] Speaker 00:
I don't want to prejudge whether or not the court feels like it needs to write an opinion on an issue, of course.

[00:11:54] Speaker 00:
But practically speaking,

[00:11:56] Speaker 00:
If this court invalidates the patent on either appeal, depending on the timing, then the case would be over.

[00:12:04] Speaker 00:
I see a meeting into my appeal, my rebuttal time.

[00:12:06] Speaker 04:
We will save it for you.

[00:12:08] Speaker 00:
Thank you.

[00:12:25] Speaker 01:
Good morning, Your Honors.

[00:12:26] Speaker 01:
May it please the Court.

[00:12:28] Speaker 01:
This case arises in the highly complex field of biotechnology, where a technically trained PTAT board was tasked with carefully evaluating an extensive amount of evidence.

[00:12:41] Speaker 01:
The board did exactly that.

[00:12:43] Speaker 01:
It analyzed the patent specification in detail.

[00:12:47] Speaker 01:
It made credibility determinations of the party's expert witnesses and weighed the evidence.

[00:12:54] Speaker 01:
And it correctly applied to law to arrive at findings supported by substantial evidence.

[00:13:01] Speaker 03:
I don't want to spend too much time on this, but I want to know very quickly, why was the PTAB so indecisive in the initiation here?

[00:13:13] Speaker 01:
Your Honor, I think when you look back at the record, what we see is that there were more than just the claims we have at issue in play here.

[00:13:23] Speaker 01:
So it wasn't a question, I'd say, from the board being indecisive as to the merits, because they were consistent

[00:13:31] Speaker 01:
on the merits, that there was at least more than one claim likely to be found unpatentable.

[00:13:38] Speaker 01:
It was questions and issues related to other considerations, such as fintiff considerations at the time.

[00:13:44] Speaker 01:
And there was also a situation where Siegen took an adverse judgment because it disclaimed some claims.

[00:13:51] Speaker 01:
So that's why you're on.

[00:13:52] Speaker 01:
And Your Honors, Siegen has said a lot about the merits, so I want to start there.

[00:13:58] Speaker 01:
Because when you look at the merits as to lack of enablement and lack of written description, it's easy to see why the board arrived at its decision.

[00:14:07] Speaker 01:
So Your Honors, as to lack of enablement, the board considered the wands factors and then found, by preponderance of the evidence, supported that there was undue experimentation to make and use the claimed ADCs.

[00:14:21] Speaker 01:
Now, what is this substantial evidence?

[00:14:25] Speaker 01:
Well, as to the factor of the breadth of the claims, we can look in the board's decision at page 48.

[00:14:30] Speaker 01:
The board found the claims extremely broad.

[00:14:35] Speaker 01:
Based on our expert, Dr. Lambert's testimony, who explained that the drug money limitation is not limited.

[00:14:43] Speaker 01:
It covers any compound, and it claims

[00:14:47] Speaker 01:
cover a vast genus of structurally and functionally disparate ABCs.

[00:14:55] Speaker 01:
As to the factor working examples, looking at the board's decision page 49 to 50, the board credited Dr. Lambert his testimony where he explained that the working examples are all limited to these dolastatin, arastatin drug moieties, which the patent is centered on.

[00:15:14] Speaker 01:
And again, Your Honors, what we're talking about is just two drug moieties in the vast universe of drug moieties encompassed by the claimed ADCs.

[00:15:24] Speaker 01:
How vast is it?

[00:15:26] Speaker 01:
Your Honor, a number of- 50?

[00:15:28] Speaker 05:
Is it 500?

[00:15:29] Speaker 01:
Is it 5 million?

[00:15:30] Speaker 01:
It's nearly limitless.

[00:15:32] Speaker 01:
It's countless.

[00:15:33] Speaker 01:
No one has even really attempted to put a number on it, Your Honor, because there are so many drug moieties.

[00:15:38] Speaker 04:
The position's drug reference, which lists all drugs, is this thick.

[00:15:42] Speaker 04:
probably tens of thousands.

[00:15:46] Speaker 01:
At least many millions, Your Honor, of drug commodities.

[00:15:50] Speaker 01:
And the board also noted this again at pages 49 and 50, that Siegen's expert was part of the substantial evidence, did not identify any working examples for what's in the claims.

[00:16:04] Speaker 01:
And they noted that the testimony of the four main inventors showed that they did not include any working examples.

[00:16:13] Speaker 01:
As to the other factor.

[00:16:15] Speaker 05:
Is the board's analysis perhaps infected by a non-claimed requirement of treating cancer?

[00:16:26] Speaker 05:
It seemed to want more than just inter-cellular cleaving in a patient.

[00:16:33] Speaker 05:
It wanted inter-cellular cleaving in a patient that would actually treat cancer or some other disease.

[00:16:42] Speaker 05:
Is that going too far because the claim doesn't call for that?

[00:16:45] Speaker 01:
Your Honor, that would be going too far, but that's not what the board did.

[00:16:49] Speaker 01:
That's an argument that Siegen made about the board's analysis.

[00:16:53] Speaker 01:
When you look at the board's analysis, Your Honor, and when it talks about the intracellular cleavage limitation in a patient,

[00:17:01] Speaker 01:
They say that that is a limitation, and it's a limitation such that it can actually work in an ADC.

[00:17:09] Speaker 01:
But for Intercellular Cleavage, all it meant was internalizing into the cell.

[00:17:14] Speaker 01:
And we know that this is really a distraction and a red herring, Your Honor, because when we look at the enablement

[00:17:21] Speaker 01:
analysis that the board made in its decision, and we look at, for example, factors such as the amount and direction or guidance presented.

[00:17:30] Speaker 01:
That was focused heavily on whether or not there were drug moieties other than these dolastatin and arastatin moieties that the patent was centered on.

[00:17:39] Speaker 01:
If we look at, for example, the factors state of the art and unpredictability of the art, right there before our eyes on page 71, the board found that Dr. Lambert was more persuasive in demonstrating significant unpredictability in attaching drugs in their linkers.

[00:17:58] Speaker 01:
And the board even found that several of the references cited by Siegen's expert, Dr. Bertozzi, actually supported unpredictability of linking drugs.

[00:18:09] Speaker 01:
And that this unpredictability was highlighted by comparative art that she cited, where it showed that attaching linkers to an antibody was very different from attaching linkers to a drug mold.

[00:18:24] Speaker 01:
And even, Your Honor, on the quantity of experimentation,

[00:18:28] Speaker 01:
And this is at page 74 of the board's decision.

[00:18:33] Speaker 01:
They found Dr. Lambert to be more persuasive in demonstrating the large quantity of experimentation required to create a particular ABC while retaining intracellular cleavage as required by the claims.

[00:18:46] Speaker 01:
And that's on page 74.

[00:18:48] Speaker 01:
And, Your Honor, when we look at the decision, there's nothing showing that the board was having some requirement that intracellular cleavage would create some particular thing

[00:18:57] Speaker 01:
for therapeutic efficacy in the patient.

[00:19:01] Speaker 01:
So when you look at the wands factors in total in the board's actual analysis, as I went through, Your Honor,

[00:19:07] Speaker 01:
It is focused so much on this unpredictability because the drug moiety is incredibly broad.

[00:19:13] Speaker 01:
Your honor, this case from an enablement perspective is very much like the Amgen case.

[00:19:19] Speaker 01:
And even in the Amgen case, that was a situation where you had 11 examples that were within the scope of the claims.

[00:19:27] Speaker 01:
Here, we have zero examples within the scope.

[00:19:31] Speaker 01:
Now, Your Honor, I want to just get to the lack of written description analysis.

[00:19:37] Speaker 01:
And the board began this analysis on page 14 of its decision.

[00:19:42] Speaker 01:
And it showed that the board applied the correct standard.

[00:19:46] Speaker 01:
What did it do, Your Honor?

[00:19:47] Speaker 01:
It explained this court's decision in the area and found that both the petitioner and Dr. Lambert proved by preponderance of evidence that the 2004 priority applications lack written description support for this tetrapeptide unit that was claimed in 2019.

[00:20:06] Speaker 01:
Now again, what is this substantial evidence supporting the board's decision?

[00:20:13] Speaker 01:
Well, the board noted Dr. Lambert, how he explained that this 81-member tetrapeptide subgenus is not disclosed in the broader genus of amino acid units.

[00:20:26] Speaker 01:
And even if you limited the amino acid units to tetrapeptides and those covered by the claim, you would cover over 47 million species.

[00:20:36] Speaker 01:
In Siegen's expert, Dr. Brattosi, she didn't disagree with that.

[00:20:39] Speaker 01:
That's in the board's decision, pages 24 to 25.

[00:20:42] Speaker 01:
In Siegen's expert, he even acknowledged that the provisional applications do not disclose an example of tetrapeptide with only glycine or phenylamine amino acids.

[00:20:54] Speaker 01:
And one of the other pieces of substantial evidence that the board focused on, and this is at page 20 of its decision, is how Dr. Lambert pointed out the testimony of the named inventors, showing a complete lack of possession of ADCs with this claimed tetrapeptide, and showing that there was no blaze marks, for example.

[00:21:16] Speaker 01:
And Your Honors, this court's precedent has explained that for the written description requirement, inventor testimony can illuminate the absence of written description.

[00:21:28] Speaker 01:
And that's, for example, in the Neuville Farms versus Dr. Reddy's case.

[00:21:32] Speaker 01:
And just completely separate from that, Your Honors, and it was mentioned early, Dr. Bertosi's analysis, the board at page 24, it looked at that analysis after

[00:21:45] Speaker 01:
just considering everything in its totality.

[00:21:48] Speaker 01:
And when it looked at Dr. Bortosi's analysis solely, and the board walks through this in pages 24 through 29,

[00:21:56] Speaker 01:
It was really the board saying that it was Dr. Bertozzi who was trying to give this impression of what a person of oriented skill would understand from the specification.

[00:22:07] Speaker 01:
And the board didn't agree with that.

[00:22:08] Speaker 01:
They rejected it.

[00:22:10] Speaker 01:
With that, Your Honor, the PTO has been allotted some time.

[00:22:13] Speaker 01:
So unless Your Honors have any questions.

[00:22:17] Speaker 01:
Fine.

[00:22:17] Speaker 01:
Fine.

[00:22:17] Speaker 01:
I'll see my time.

[00:22:23] Speaker 04:
Thank you.

[00:22:23] Speaker 04:
You can set that for five minutes to give it

[00:22:26] Speaker 04:
for the extra two.

[00:22:33] Speaker 04:
Is it Ms.

[00:22:34] Speaker 04:
Wang?

[00:22:35] Speaker 02:
Yes, Your Honor.

[00:22:43] Speaker 02:
Good morning, Your Honor.

[00:22:45] Speaker 02:
And may it please the court, Shella Wang for the Director of the USPTO.

[00:22:49] Speaker 02:
This court may not review the board's threshold institution-based determination that post-grant review is available for the 039 patent.

[00:22:57] Speaker 02:
That is a final and non-appealable determination under Section 324E, and the court should hold that it lacks jurisdiction to review CIGEN's challenge to PGR eligibility.

[00:23:07] Speaker 04:
In other words, it relates to the decision to institute.

[00:23:10] Speaker 02:
Correct, Your Honor.

[00:23:11] Speaker 02:
And just like this court held in CIPCO,

[00:23:15] Speaker 02:
eligibility determination, be it in the context of CDM eligibility or PGR eligibility determination.

[00:23:21] Speaker 02:
The analysis is the same.

[00:23:22] Speaker 02:
This court may not review such a determination.

[00:23:24] Speaker 03:
What are you doing in a situation like this where the decision to institute is tied up with a question that's a merits question?

[00:23:33] Speaker 02:
So Your Honor, I'd like to acknowledge that there's that tension in this particular case.

[00:23:38] Speaker 02:
But the facts of this case cannot dictate the statutory construction here or the statutory interpretation here.

[00:23:45] Speaker 02:
It's entirely possible for PGRs to proceed, for the board to make a determination of PGR eligibility on, for example, one claim.

[00:23:55] Speaker 02:
and then have the review proceed on the remaining claims.

[00:23:59] Speaker 02:
So there isn't this 100% overlap substantively possible in every single case.

[00:24:05] Speaker 02:
And so the facts of this particular case, where the 2004 specification and the 2019 specification are substantively identical, should not dictate how we construe the PGR eligibility and the application of 324.

[00:24:19] Speaker 03:
You heard the question I asked of your friend about the indecision of the board to institute.

[00:24:24] Speaker 02:
Correct, Your Honor.

[00:24:25] Speaker 03:
I actually meant that for you.

[00:24:26] Speaker 02:
That's fine, Your Honor.

[00:24:28] Speaker 03:
Very quickly.

[00:24:29] Speaker 03:
Just a quick answer.

[00:24:30] Speaker 02:
I anticipated that question, Your Honor.

[00:24:31] Speaker 02:
So I think what happened here, Your Honor, if you look at the procedural history, is that there were decisions to institute or de-institute and serial petitions for rehearing.

[00:24:42] Speaker 02:
At each step,

[00:24:43] Speaker 02:
The district court litigation or a different PGR on a subset of claims of this patent were differently placed.

[00:24:51] Speaker 02:
So the board's analysis and the board's application of its discretion to deny or to institute was different.

[00:24:58] Speaker 02:
The board was merely responding to the changed circumstances and the subsequent rehearing petitions that either side was filing.

[00:25:13] Speaker 02:
If I may just briefly touch on, unless the court has other questions on reviewability, I'll briefly touch on the test that CJIN is proposing.

[00:25:23] Speaker 02:
That test is entirely divorced from the statutory text.

[00:25:26] Speaker 02:
It does not contemplate what the statute says.

[00:25:30] Speaker 02:
The statute defines PGR eligibility

[00:25:32] Speaker 02:
by reference to effective filing date.

[00:25:35] Speaker 02:
So if Your Honor's reached that decision, which we don't believe the court has the power to, but if the court disagrees with us on reviewability, the correct test is the one that the board applied here.

[00:25:49] Speaker 02:
Unless there are any other questions at all.

[00:25:52] Speaker 04:
Thank you very much.

[00:25:53] Speaker 04:
Thank you, Your Honor.

[00:25:55] Speaker 04:
Ms.

[00:25:55] Speaker 04:
Horton has a little rebuttal time.

[00:25:58] Speaker 00:
Thank you, Your Honors, to pick up right where Ms.

[00:26:02] Speaker 00:
Lynn just left off on the reviewability of the issue on PGR eligibility.

[00:26:10] Speaker 00:
I think she mentioned, as does the intervener's brief, that here there is a tension because the eligibility issue is so tied up with the merits issue.

[00:26:20] Speaker 00:
The history of this proceeding is important.

[00:26:22] Speaker 00:
It was discretionarily denied.

[00:26:24] Speaker 00:
It was instituted.

[00:26:25] Speaker 00:
It was reinstituted.

[00:26:27] Speaker 00:
The resulting final written decision canceling the claims came long after the jury verdict and nearly three years after the petition was filed.

[00:26:36] Speaker 00:
The issue of PGR eligibility came up over and over again in these decisions that led us to the final written decision.

[00:26:44] Speaker 04:
At the institution stage... The question isn't PGR eligibility, it's whether it's appealable.

[00:26:52] Speaker 00:
Right.

[00:26:52] Speaker 00:
To the point of appealability,

[00:26:54] Speaker 00:
Your Honor, at the institution stage, the board's finding was that whether or not there was eligibility here and whether or not there was the transitional application of the 039 harkened back to the earlier pre-AIA non-PGR-able patent was preliminary to be further examined during the trial.

[00:27:17] Speaker 00:
for example, at Apex 595 in the first institution decision that it is more likely than not that petitioner would demonstrate lack of enablement, et cetera, et cetera, and then said, for purposes of this decision, the institution decision, we find

[00:27:34] Speaker 00:
that the 039 patent is eligible for post-grant review.

[00:27:38] Speaker 00:
Then also, before the final written decision, on the same enablement of question at Apex 868, the board later acknowledged the possibility that the entirety of the evidence adduced at trial might lead us to a different conclusion.

[00:27:56] Speaker 00:
So there was no institution decision that was up or down, like the SIPCO case that the intervener

[00:28:02] Speaker 00:
relies on, or like the Thrive or Click to Call.

[00:28:05] Speaker 00:
The issue of INSIPCO where the issue on institution decision was, is this patent CVM reviewable, yes or no?

[00:28:14] Speaker 00:
That was a decision squarely decided for purposes of institution and nothing else.

[00:28:20] Speaker 00:
Here we have this situation

[00:28:22] Speaker 00:
where the merits and the eligibility question rose and fall together and were continued to be litigated after the institution decision and all the way to the final written decision.

[00:28:34] Speaker 00:
We could have been in a situation here, Your Honor, which we think is inappropriate, where the patent owner finds out only after going through an entire trial that the PGR never should have been instituted in the first place because the board lacked jurisdiction or standing to look at the

[00:28:51] Speaker 00:
transitional patent.

[00:28:54] Speaker 00:
I just want to say a few more things with my 19 seconds.

[00:28:56] Speaker 00:
We think that the board erred in its final written decision finding that the non-enablement rests on improper claim construction and erroneous fact findings that impose therapeutic efficacy requirements into the 039 patent claims were nonexist.

[00:29:11] Speaker 00:
The board also erred in finding a lack of written description when it misstated the law and held the siege into a higher standard than this court

[00:29:18] Speaker 00:
requires and demands for written description for the same reasons the 039 patent would satisfy the written description and has priority.

[00:29:26] Speaker 00:
That would mean that the patent is not anticipated then by the later reference as found by the final decision.

[00:29:37] Speaker 00:
Thank you, Your Honor.

[00:29:38] Speaker 04:
Thank you both.

[00:29:40] Speaker 04:
The case was submitted and that concludes today's argument.