[00:00:52] Speaker 05:
Mr. Prugo, please proceed.

[00:01:15] Speaker 02:
Good morning.

[00:01:16] Speaker 02:
If you may please the court.

[00:01:18] Speaker 02:
Philco Prugo on behalf of Genzar.

[00:01:21] Speaker 02:
We're here today with respect to two patents that cover the first and only FDA approved treatments for Pompe disease.

[00:01:30] Speaker 02:
And here we have two institution decisions.

[00:01:34] Speaker 02:
In the very truncated, short amount of time, Genzyme had to respond to those two institution decisions.

[00:01:43] Speaker 02:
It did everything the regulations required of it.

[00:01:49] Speaker 02:
It responded fully.

[00:01:51] Speaker 02:
to the grounds of unpatentability as set forth in those institution decisions.

[00:01:57] Speaker 02:
At the end of the day, in the final written decisions, the board actually agreed with Genzyme.

[00:02:05] Speaker 02:
The board recognized that the grounds of unpatentability set forth in those institution decisions

[00:02:12] Speaker 02:
were insufficient.

[00:02:14] Speaker 05:
I thought that the board said that it was, in fact, making its decision on the exact ground that was instituted.

[00:02:22] Speaker 02:
Well, it's clear that they didn't make a decision on the same grounds as were instituted.

[00:02:27] Speaker 05:
You think just because they referenced another reference, that that means they didn't deny on that ground?

[00:02:35] Speaker 05:
Have you ever read our anticipation law?

[00:02:37] Speaker 05:
Anticipation law, as you probably know,

[00:02:39] Speaker 05:
requires a single prior art to disclose all the claim elements.

[00:02:44] Speaker 05:
What we validated time and time again is you can use another reference to see if the first reference does in fact disclose everything.

[00:02:55] Speaker 05:
Why isn't that what they did here?

[00:02:57] Speaker 05:
You raised the question of reasonable expectation of success of the references that were the basis of the institution decision.

[00:03:03] Speaker 05:
And they used another reference to come along and show why those institution decision references would have been viewed by one of skill in the art of having a reasonable expectation of success.

[00:03:17] Speaker 02:
It's clear that the institution decision references themselves actually could not supply the reasonable expectation of success.

[00:03:26] Speaker 02:
That's very clear, because at best, they reference in vitro data.

[00:03:31] Speaker 02:
And what we have is a recognition at the end of the day that in vitro data is not predictive of what happens in vivo.

[00:03:40] Speaker 02:
It's not predictive of what happens in a human patient.

[00:03:42] Speaker 05:
Did the board find that?

[00:03:43] Speaker 05:
I didn't see a fact finding to that extent.

[00:03:45] Speaker 05:
And it's my understanding that it's your obligation to prove that fact, if true.

[00:03:52] Speaker 02:
Well, the argument that was made in the Pat Nono response was the institution decision only references reference

[00:04:00] Speaker 02:
references that have in vitro data.

[00:04:03] Speaker 02:
The argument was twofold.

[00:04:05] Speaker 02:
One, you haven't in the institution decisions set forth a reasonable expectation of success analysis at all.

[00:04:12] Speaker 02:
Full stop.

[00:04:13] Speaker 02:
Genzyme went further to say, and in any event, if you look in detail

[00:04:17] Speaker 02:
At the references, they only have in vitro data.

[00:04:20] Speaker 05:
But I don't understand.

[00:04:21] Speaker 05:
In vitro data, in many instances, can be predictive of success, even in humans, jump over the step of in vivo.

[00:04:28] Speaker 05:
In some instances, absolutely, it cannot be.

[00:04:32] Speaker 05:
So the patent office presented in the institution decision a conclusion that, by a preponderance, it looked as though, more likely than not, the claims would be invalidated based on these four, which included in vitro data.

[00:04:46] Speaker 05:
You raised a question about whether the in vitro data would be predictive of human success or applicability.

[00:04:56] Speaker 05:
And the Patent Office basically rebutted your concerns.

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

[00:05:03] Speaker 05:
I don't understand why that changes the nature of the grounds of institution.

[00:05:08] Speaker 02:
The Patent Office at the end of the day didn't rebut our concerns.

[00:05:11] Speaker 02:
They went around them.

[00:05:14] Speaker 02:
and added to the in vitro data in vivo data.

[00:05:17] Speaker 05:
No, they've demonstrated that in this case, the in vitro data is predictive of in vivo data, which is predictive of human application.

[00:05:26] Speaker 02:
I don't believe there's a fact finding that says in vitro data is predictive of in vivo results.

[00:05:31] Speaker 02:
There is simply not in the institution decision, in the final rate decisions, that finding.

[00:05:35] Speaker 02:
Quite the opposite.

[00:05:36] Speaker 02:
What you have

[00:05:37] Speaker 02:
in both final written decisions.

[00:05:39] Speaker 05:
Do you have any fact-finding by the PTO that says that the in vitro data is not predictive of in vivo results?

[00:05:48] Speaker 02:
Well, that's self-evident from their analysis.

[00:05:51] Speaker 02:
At the end of the day, when they describe the scope and the content of the prior art, they bulleted out in both decisions, both final written decisions, they bulleted out one, two, three, four.

[00:06:02] Speaker 02:
They define what is the scope and the content of the prior art.

[00:06:05] Speaker 02:
They include in vitro data, and then they include in vivo data.

[00:06:09] Speaker 02:
They don't say that in vitro data is predictive of what happens in vivo.

[00:06:14] Speaker 02:
They redefine the scope and the content of the prior art using in vivo data, and then conclude that based on that information, there is a reasonable expectation of success.

[00:06:26] Speaker 02:
Nowhere did they say that in vitro is predictive of what happens in vivo, and quite the opposite.

[00:06:32] Speaker 02:
If they believe that, there would have been no reason at all to add or rely on new references.

[00:06:40] Speaker 02:
And let's not forget, one of the new references is a 102A reference.

[00:06:44] Speaker 02:
It's the Kikuchi reference, to which genzyme, had it been given proper notice, could have swore behind.

[00:06:51] Speaker 03:
Is my understanding correct that you didn't object to the use of the in vivo data?

[00:06:57] Speaker 02:
We actually, in our Patent Owner response, made it very clear that we should win because the institution decision does not set forth a reasonable expectation of success and at best only contains in vitro data which is insufficient.

[00:07:14] Speaker 02:
And at that point we also said

[00:07:16] Speaker 02:
according to the APA, according to this court's Rambus decision.

[00:07:20] Speaker 03:
I saw that one.

[00:07:21] Speaker 03:
Did you move to exclude that evidence once it was submitted?

[00:07:25] Speaker 02:
We didn't feel it was necessary to move to exclude the evidence, because the case had been set forth by the Patent Office as it's required to do.

[00:07:33] Speaker 02:
This court's Belledon decision makes it very clear.

[00:07:36] Speaker 02:
It is the PTO in the institution decisions that has to set forth the facts and the law that the patent owner has to meet.

[00:07:43] Speaker 02:
That's exactly what Jensheim did.

[00:07:46] Speaker 02:
Biomeran or any other petitioner cannot change that notice unilaterally.

[00:07:51] Speaker 02:
It is up to the agency to provide the requisite notice.

[00:07:55] Speaker 02:
And it's that notice that patent owners respond to.

[00:07:58] Speaker 02:
And once you respond, let's remember, once the patent owner puts its stake in the ground, if you will, that is your case.

[00:08:07] Speaker 02:
Your complete case has gone in at the patent owner response stage.

[00:08:16] Speaker 02:
So in this case, in the final written decisions, it's very clear that, in fact, the board agreed with Genzyme that in vitro data was insufficient.

[00:08:27] Speaker 02:
There's no other reason to have to rely on the in vivo data.

[00:08:31] Speaker 02:
They relied on in vivo data from new references, not at all mentioned in the institution decision, including, as I mentioned before, the Kikuchi reference.

[00:08:43] Speaker 02:
Of course, had Genzyme been given notice of that case, had Genzyme been told this is the case you had to meet, they would have fully met that case, including swearing behind the Kikuchi reference.

[00:08:57] Speaker 02:
That's precisely why this court in the Belden decision said the Patent Office can't just change theories midstream without giving notice.

[00:09:07] Speaker 02:
That's why this court in Biderman and other cases has said,

[00:09:11] Speaker 02:
you have to stick with the thrust of the rejection.

[00:09:14] Speaker 02:
There's been a clear change in the theory.

[00:09:17] Speaker 02:
There's been a clear change in the thrust of the rejection here.

[00:09:22] Speaker 02:
There's no question about that.

[00:09:23] Speaker 02:
You have an institution decision that doesn't delineate at all the reasonable expectation of success, that at best relies on in vitro data.

[00:09:32] Speaker 02:
And that's Genzyme looking at the references blindly, without a case before it, saying at best you have in vitro data.

[00:09:40] Speaker 02:
And the board, at the end of the day, completely changing its analysis.

[00:09:44] Speaker 02:
It extracts from the references in the institution decision new facts, new rationales, and then relies on new references and new data in vivo data from two references not at all referred to in the institution decisions defined against genocide.

[00:10:02] Speaker 04:
What, if any, would you say, under your theory of the case,

[00:10:08] Speaker 04:
that the board could in, not just in this case, but in general, what new references could the board rely on in the course of the trial and for what purposes?

[00:10:23] Speaker 02:
As long as the, this court has already set out a flexible test that we can apply, and that is has the thrust of the rejection changed?

[00:10:34] Speaker 02:
So to the extent you rely on a new reference or new information or new arguments, as long as you haven't changed the thrust of that rejection, as long as you haven't changed your theory of the case, it's okay.

[00:10:48] Speaker 02:
But when you have a situation where you don't discuss reasonable expectation of success at all, let alone the importance of in vivo data, and then in the final written decision,

[00:10:59] Speaker 02:
Define the scope and the content of the prior art, and you bullet it out, and you include in vivo data, including a 102A reference that could have been sworn behind.

[00:11:08] Speaker 02:
That's clearly changing the thrust of the rejection.

[00:11:12] Speaker 02:
It's clearly changing the theory of the case.

[00:11:15] Speaker 04:
What about a case in which the patent owner comes in with a defense or an assertion of fact or law that goes beyond in the sense of raising

[00:11:28] Speaker 04:
a new issue that wasn't anticipated in the institution decision, doesn't that give the board an authority to bring in more material to respond?

[00:11:42] Speaker 02:
I guess it would be a very fact-dependent analysis.

[00:11:45] Speaker 02:
But to that, I would say this.

[00:11:47] Speaker 02:
If you have a situation, such as the case before you today, where the board doesn't set forth a prima facie case

[00:11:56] Speaker 02:
of obviousness in its institution decisions.

[00:11:59] Speaker 02:
It didn't do that.

[00:12:00] Speaker 02:
It didn't do that because it didn't even discuss reasonable expectation of success.

[00:12:05] Speaker 02:
When the patent owner raises that issue, if indeed the board hasn't raised the prima facie case, the patent owner should in that case prevail.

[00:12:20] Speaker 02:
Now, to the extent the board recognizes there's an error, there's an opportunity

[00:12:25] Speaker 02:
to say, yes, I'll give you notice, and you have a full opportunity to respond.

[00:12:31] Speaker 02:
If that's what the board did, we wouldn't be here.

[00:12:34] Speaker 02:
But you have to give the patent owner that full and fair opportunity to respond to whatever it is the board wants to explore at the end of the day.

[00:12:42] Speaker 02:
Now, the opposite extreme is if the patent owner raises an issue, and that issue isn't important to the ultimate conclusion, the board can simply ignore it.

[00:12:51] Speaker 02:
You move forward and you say, that doesn't affect our analysis.

[00:12:55] Speaker 05:
Do you want to reserve the remainder of your time for rebuttal?

[00:13:00] Speaker 05:
Sure, Your Honor.

[00:13:04] Speaker 05:
Mr. Murphy?

[00:13:15] Speaker 01:
I'd like to talk about what this case is really all about.

[00:13:20] Speaker 01:
And in this case, the board instituted an inter-parties review proceeding against two patents on certain grounds.

[00:13:28] Speaker 01:
And I guess one of the issues is, what is a ground?

[00:13:32] Speaker 01:
And the institution decision identified the grounds for the 410 patent, for example, as ground one was claim one is obvious over, or I'll just read it directly,

[00:13:49] Speaker 01:
Ground one, claim one under 35 USC 103 as obvious over the combination of the Duke press release 1997, Barton and Vanderploeg.

[00:13:59] Speaker 01:
And then ground two, claim one under 35 USC 103 as obvious over the combination of Racer, Barton, and Vanderploeg.

[00:14:07] Speaker 01:
Joint appendix A164 and joint appendix 167.

[00:14:14] Speaker 01:
The final written decisions for this patent, and we have a parallel

[00:14:19] Speaker 01:
Rulings in the other patent broke out those same two grounds in their final written opinion, joint appendix A11 through 18 for ground one, joint appendix A18 to 21 for ground two.

[00:14:34] Speaker 01:
Getting to the notice issue under the APA, and that's guided mainly by the APA and also by case law, the notice of the grounds comes from the board.

[00:14:46] Speaker 01:
The board didn't vary from the grounds.

[00:14:49] Speaker 01:
remain the same from the institution decisions to the final written decision.

[00:14:57] Speaker 01:
In addition to the grounds, the formal grounds, quote, grounds, there's also issues, quote, issues and facts that arise during a trial.

[00:15:06] Speaker 01:
Both parties, there's certain issues that the board is always going to look at.

[00:15:10] Speaker 01:
Reasonable expectation of success would be one, state of the art.

[00:15:14] Speaker 01:
There's certain things under KSR.

[00:15:17] Speaker 01:
There's just certain things you always look at in an obviousness analysis.

[00:15:20] Speaker 05:
If in an obviousness analysis it was the case that after the institution decision the board realized that one of the elements was actually missing from the references.

[00:15:32] Speaker 05:
In which case?

[00:15:34] Speaker 05:
It was the case that the board realized that one of the elements of the claim was actually not in any of the pieces of prior art that were argued to render it obvious.

[00:15:48] Speaker 05:
Is it your argument that the board would be permitted then, in its final decision, and to say the patentee pointed this out in its response?

[00:15:57] Speaker 05:
Is it your argument that the board would be permitted then in its final decision to add another reference to the ground to supply the missing element?

[00:16:08] Speaker 01:
I think that there's case law that suggests they would not be able to do that in certain circumstances.

[00:16:13] Speaker 01:
Without notice, right?

[00:16:15] Speaker 01:
Without notice.

[00:16:15] Speaker 01:
Well, sure.

[00:16:16] Speaker 01:
If they gave notice, sure.

[00:16:17] Speaker 01:
If they gave notice, they could do that.

[00:16:19] Speaker 01:
If they didn't give notice.

[00:16:21] Speaker 01:
I'm sorry.

[00:16:21] Speaker 04:
And an opportunity to respond.

[00:16:23] Speaker 04:
Right.

[00:16:25] Speaker 01:
Yes.

[00:16:26] Speaker 05:
So your argument isn't that the board is free to add additional references, even if those references were somewhere in your petition, but not the basis upon which grounds were granted.

[00:16:43] Speaker 05:
Just the fact that those references may appear in other grounds that you alleged, which the board denied, that still wouldn't make it sufficient for the board to pull one of those in for a missing element to be supplied.

[00:16:56] Speaker 01:
Well, in this case, I think... I don't want to know about this case.

[00:16:59] Speaker 05:
I want to know about my case that I just don't know about.

[00:17:02] Speaker 01:
If they were pulling in for a missing element, they would have to give the other party notice.

[00:17:05] Speaker 05:
An opportunity to respond.

[00:17:06] Speaker 01:
Yes, notice, opportunity to respond.

[00:17:07] Speaker 05:
Because otherwise, it's a different grounds.

[00:17:10] Speaker 01:
Yes, I think you could argue that.

[00:17:11] Speaker 01:
You could argue that.

[00:17:12] Speaker 05:
Yeah, okay.

[00:17:12] Speaker 05:
But you think this is sufficiently different from that because in this case, the board is only trying to explain what these four references actually teach one of skill and the art at that time in the field.

[00:17:24] Speaker 01:
Yes, that's exactly our position, yes.

[00:17:29] Speaker 01:
I would like to talk about the Belden case that was cited in the reply.

[00:17:37] Speaker 01:
We had already filed all our filings by that time.

[00:17:49] Speaker 01:
The Belden case at 1080.

[00:17:55] Speaker 01:
indicates that for formal adjudications, the Administrative Procedure Act requires the PTO to give certain notice.

[00:18:04] Speaker 01:
And this is a sentence that was quoted by Genzyme.

[00:18:07] Speaker 01:
But if you read the rest of the sentence, and permits a party to submit rebuttal evidence and to conduct such cross-examination as may be required for a full and true disclosure of the facts.

[00:18:20] Speaker 01:
So the Administrative Procedure Act

[00:18:24] Speaker 01:
allows Biomerin to respond to any issues raised during the proceeding and to submit rebuttal evidence.

[00:18:34] Speaker 01:
The essential question is whether Genzyme had a full and fair opportunity to respond to the issue of reasonable expectation of success.

[00:18:42] Speaker 01:
Genzyme interjected or raised that issue in its patent owner response, and they came at it from all different angles.

[00:18:51] Speaker 01:
In addition to Genzyme raising it in their patent-owner response, we've cited in our brief the pages where they dealt with reasonable expectation of success.

[00:19:00] Speaker 01:
Our witness, Dr. Pastores, covered that in great detail in his brief.

[00:19:05] Speaker 01:
And those citations are in his declaration.

[00:19:08] Speaker 01:
And we covered reasonable expectation of success in great detail in our petition.

[00:19:14] Speaker 01:
So this was not a surprising issue

[00:19:17] Speaker 01:
You can't make an issue go away by ignoring it.

[00:19:20] Speaker 01:
I think what Genzyme is trying to do is we have a case.

[00:19:23] Speaker 01:
We raised reasonable expectation of success in our petition.

[00:19:26] Speaker 01:
We talked about in vivo data.

[00:19:28] Speaker 01:
We talked about in vitro data.

[00:19:30] Speaker 01:
Our witness testified from the state of the art a year before the filing date.

[00:19:36] Speaker 01:
And then he confirmed his opinion that it would be the same right before the filing date when he discussed those intervening references.

[00:19:44] Speaker 01:
Genzyme chose to go with the

[00:19:48] Speaker 01:
date of December 1998 as the date to have their witnesses testify from.

[00:19:53] Speaker 01:
So both parties submitted testimony as to the state of the art as of December 1998.

[00:20:01] Speaker 01:
So it's hard to understand how you can say that this is the critical date and that the prior art has to be viewed from an art position.

[00:20:15] Speaker 01:
And there's case law.

[00:20:17] Speaker 01:
that I'll direct the board's attention to custom accessories, that it is presumed that an inventor has knowledge of all relevant art.

[00:20:26] Speaker 01:
So the grounds have all the elements.

[00:20:27] Speaker 01:
The grounds have motivation.

[00:20:29] Speaker 01:
And we took a position that it was a reasonable expectation of success.

[00:20:34] Speaker 01:
Genzyme said there's no expectation of success.

[00:20:36] Speaker 01:
That was fully litigated.

[00:20:38] Speaker 01:
They raised it.

[00:20:38] Speaker 01:
We raised it.

[00:20:40] Speaker 01:
Everybody argued it.

[00:20:41] Speaker 01:
And the board found that the

[00:20:43] Speaker 01:
grounds that were instituted, there was a reasonable expectation of success.

[00:20:47] Speaker 01:
They found that once in the institution decision, and they found it again in the final written decision.

[00:20:54] Speaker 01:
And in the final written decision, they relied primarily on the references in the ground.

[00:20:59] Speaker 01:
And then, by the way, there's this other prior art that also shows there's a reasonable expectation of success.

[00:21:08] Speaker 05:
I didn't see anywhere where the board made a fact finding that in vitro data in this case is not predictive of in vivo results or anything like that.

[00:21:20] Speaker 05:
Was there a determination either way on this?

[00:21:23] Speaker 01:
There was no expressed finding that I'm not aware either where the board said in vivo is predictive by itself.

[00:21:31] Speaker 01:
But you have to, but I think it's certainly implicit

[00:21:35] Speaker 04:
You mean in vitro?

[00:21:36] Speaker 01:
Yeah.

[00:21:36] Speaker 01:
I meant in vitro.

[00:21:37] Speaker 01:
Sorry.

[00:21:38] Speaker 01:
In vitro isn't predictive.

[00:21:40] Speaker 01:
I don't think you can find a quote where they said in vitro is predictive or is not predictive by itself.

[00:21:45] Speaker 01:
But it's implicit that since they're looking at the state of the art from December of 1998, according to both parties, you look at the in vitro data.

[00:21:57] Speaker 01:
And then you also look, what's the state of the art at the time?

[00:21:59] Speaker 01:
The state of the art, there was all kinds of prior art talking about that this was likely to get to

[00:22:04] Speaker 01:
likely to be a successful therapy.

[00:22:06] Speaker 01:
And I can pull out the Duke press release, for example, and there's a quote.

[00:22:11] Speaker 01:
I'll just quote it.

[00:22:17] Speaker 01:
I've got it here.

[00:22:18] Speaker 05:
That's OK.

[00:22:18] Speaker 05:
We have it.

[00:22:19] Speaker 01:
Anyhow, that it was likely to reach skeletal muscles.

[00:22:22] Speaker 01:
That's one of the references relied on in the grounds.

[00:22:25] Speaker 01:
It's only a two-page document.

[00:22:28] Speaker 01:
That was a press release.

[00:22:29] Speaker 01:
There's also other

[00:22:30] Speaker 01:
prior art, and we discussed that in our briefs, that people were excited.

[00:22:34] Speaker 01:
People thought this was going to work.

[00:22:36] Speaker 01:
Now, nobody could predict for sure that it was going to work.

[00:22:41] Speaker 01:
So the board properly found all you need is a reasonable expectation of success.

[00:22:44] Speaker 01:
You don't need a guarantee.

[00:22:45] Speaker 01:
You don't need to run clinical trials.

[00:22:47] Speaker 01:
All you need is a reasonable expectation of success.

[00:22:50] Speaker 01:
That's based on everything in the art, including the grounds of invalidation.

[00:22:55] Speaker 05:
Thank you.

[00:22:57] Speaker 05:
Do you have anything further?

[00:22:57] Speaker 05:
You seem like you were concluding.

[00:22:59] Speaker 01:
I've come concluded.

[00:23:01] Speaker 01:
Very good.

[00:23:01] Speaker 05:
Okay.

[00:23:02] Speaker 05:
Thank you.

[00:23:03] Speaker 05:
Mr. Hickman.

[00:23:04] Speaker 00:
Good morning.

[00:23:13] Speaker 00:
May it please the court.

[00:23:14] Speaker 00:
I have nothing further to add this morning.

[00:23:17] Speaker 00:
I would simply echo the arguments that Biomaren made, unless there are particular questions.

[00:23:21] Speaker 05:
So do you agree with Biomaren's response to my hypothetical, which is

[00:23:26] Speaker 05:
if rather than simply proving what these references do in fact disclose, if the PTO was seeking to add a reference in order to provide a missing element, that that would constitute a new ground and it wouldn't be appropriate for the board to do that without notice and comment.

[00:23:46] Speaker 00:
Well, I agree that

[00:23:49] Speaker 00:
Notice and comment would be necessary to ensure that the patent owner is apprised as to what the element is and to provide the patent owner with an opportunity to address it.

[00:23:59] Speaker 00:
I would disagree that it would be a new ground in the sense, I disagree that the new grounds of rejection doctrine would apply to the IPR context.

[00:24:15] Speaker 05:
Wait, so you mean all of the case law from the board, even in the MPEP, which discusses when something constitutes a new ground of rejection if made by the board for the first time in a normal prosecution outside of IPR context, that that constitutes a new grounds of rejection, which it clearly would under the board's own law and the PTO's own procedure.

[00:24:41] Speaker 05:
adding a new reference for the purpose of supplying a missing element has always been recognized as constituting a new ground of rejection by the board itself, as well as by this court.

[00:24:53] Speaker 05:
And it requires notice.

[00:24:54] Speaker 05:
I said notice and comment, but I meant notice and opportunity to be heard.

[00:24:58] Speaker 05:
You're saying that's not applicable here?

[00:25:01] Speaker 05:
I guess I misunderstood your last comment.

[00:25:07] Speaker 00:
Well, I guess let me try to illustrate.

[00:25:10] Speaker 00:
In your honor's hypothetical, I agree that the board would be required probably to issue something that would probably some sort of order coming from the board that actually notifies the parties as to what this new reference, this core reference part of the combination that's now in play basically

[00:25:37] Speaker 00:
to clarify what the board's institution decision was.

[00:25:41] Speaker 00:
I think why I say the new grounds cases from the examination context would not directly apply is because we don't have an examiner involved.

[00:25:53] Speaker 00:
We don't have the rejection and response format.

[00:25:56] Speaker 00:
And so the way there are many different permutations throughout an IPR trial as to how a new issue

[00:26:06] Speaker 00:
that might require notice might come up and how the board might satisfy it.

[00:26:11] Speaker 00:
And so, for instance, if there were something that if the patent owner were to raise in the patent owner's response that showed the board that it should actually reconsider what the grounds are that are under consideration during trial, I wouldn't rule out the possibility that the board, even at a later stage, could still

[00:26:35] Speaker 00:
provide adequate notice, and still provide the patent owner a fair opportunity to respond.

[00:26:43] Speaker 00:
It could happen by issuing an order.

[00:26:49] Speaker 00:
I wouldn't rule out that it couldn't happen at an oral hearing.

[00:26:57] Speaker 00:
It would depend on sort of what happened through the course of discovery and through the briefing.

[00:27:05] Speaker 00:
My answer is a yes, that notice and an opportunity to respond would be required.

[00:27:10] Speaker 00:
But there are different ways that that could be satisfied.

[00:27:15] Speaker 04:
Does it, if I could just ask one further question, does it strike you as clear that there's a shock line dividing references that would be deemed to be new references for purposes of invalidation versus references relied on as

[00:27:34] Speaker 04:
providing evidence of the state of the art.

[00:27:38] Speaker 04:
My instinct is that there's some significant risk of swap over between the two, but I wonder if the PTO has a position on that.

[00:27:47] Speaker 00:
I think typically it's pretty clear because the board's practice in the institution decisions is to actually set forth the combinations and the grounds of unpatentability that are going to proceed to trial and the combination of those references

[00:28:04] Speaker 00:
that make up the grounds.

[00:28:06] Speaker 00:
And as here, there are many other references that were cited to prove the state of the art.

[00:28:13] Speaker 04:
Right.

[00:28:14] Speaker 04:
But suppose one of those references were offered to prove the state of the art was a particularly telling reference, which was actually stronger in the sense that it gave the board more comfort with the ultimate outcome in the case than one of the cited references.

[00:28:32] Speaker 04:
become something other than merely a reference to tell you what the state of the art is?

[00:28:36] Speaker 04:
Because, of course, all references tell you what the state of the art is, because they're all prior art.

[00:28:42] Speaker 00:
And it is quite possible that it's plausible that it could, as trial goes on, that it becomes apparent that that reference is even more important.

[00:28:51] Speaker 00:
And it's also possible that the parties would have clear notice of that because of the way the litigation develops.

[00:29:01] Speaker 00:
So yes, notice and an opportunity to respond would be required.

[00:29:07] Speaker 00:
Could the board do it?

[00:29:07] Speaker 00:
Yes.

[00:29:08] Speaker 00:
But would the board have to do it every time?

[00:29:10] Speaker 00:
I don't think so.

[00:29:11] Speaker 00:
And I think it's Judge Bryson.

[00:29:12] Speaker 05:
Thank you.

[00:29:16] Speaker 05:
All right.

[00:29:17] Speaker 05:
Thank you.

[00:29:17] Speaker 05:
Mr. Hickman.

[00:29:17] Speaker 05:
Thank you.

[00:29:18] Speaker 05:
Mr. Pruko, some rebuttal time.

[00:29:27] Speaker 02:
Your Honors, I'd like to step back for a minute.

[00:29:30] Speaker 02:
And think about how this process works.

[00:29:32] Speaker 02:
The PTO gets a petition.

[00:29:35] Speaker 02:
And pursuant to 314 sub-A of the Patent Act, there's a threshold requirement.

[00:29:40] Speaker 02:
The threshold requirement can only be answered by the PTO.

[00:29:45] Speaker 02:
That's sub-B.

[00:29:46] Speaker 02:
And sub-C says they issue a decision.

[00:29:49] Speaker 02:
And that decision is issued by the PTO.

[00:29:53] Speaker 02:
That's the institution decision.

[00:29:55] Speaker 02:
557 sub-C sub-3 of the APA

[00:30:01] Speaker 02:
says for every decision rendered by an agency, everyone, that would include this institution decision, you have to set forth your reasons, your reasons why that threshold requirement is met, and all, not some subset.

[00:30:14] Speaker 02:
The statutory provision doesn't talk about subset, skeleton, ideas.

[00:30:18] Speaker 02:
It says all, all facts and all law that are relevant.

[00:30:22] Speaker 02:
So to the extent there is an in vivo reference that's necessary to interpret in vitro data, that's material.

[00:30:29] Speaker 02:
That's clearly material.

[00:30:31] Speaker 02:
And it's clearly mandated by the APA that it be set forth in that institution decision.

[00:30:37] Speaker 02:
And that just makes sense.

[00:30:39] Speaker 02:
The patent owner shouldn't be left to guess what is material in terms of interpreting whatever it is that is in the grounds.

[00:30:46] Speaker 02:
The APA demands, demands notice of all the facts and all the law.

[00:30:51] Speaker 03:
If at that point in the litigation, you're seeing the reference morphing from

[00:30:57] Speaker 03:
one that informs in the field in the art to one that's going to be the primary reference.

[00:31:06] Speaker 03:
Why don't you object at that time?

[00:31:11] Speaker 03:
Why don't you move to exclude that evidence and say, board, you're morphing this reference now from one that informs in the field in the art to something else?

[00:31:21] Speaker 02:
Your Honor, that's because you don't know that they're actually going to take that path.

[00:31:24] Speaker 02:
And we weren't told that they were going to take that path until the final written decisions.

[00:31:28] Speaker 02:
Here, we were given notice of the case as they were supposed to give us notice.

[00:31:33] Speaker 02:
No other notice was provided by the board.

[00:31:37] Speaker 02:
They didn't say you have to deal with any other case.

[00:31:40] Speaker 02:
They said, deal with our institution decisions.

[00:31:42] Speaker 02:
We did that.

[00:31:43] Speaker 02:
It's clear what is in the institution decisions are insufficient for the purposes of finding unpatentability here.

[00:31:50] Speaker 02:
And Judge Bryson, to your earlier point, can the board respond to Genzyme without it being a new ground?

[00:31:56] Speaker 02:
Well, if we look at this court's Biederman decision,

[00:31:59] Speaker 02:
A new ground of rejection is not negated by the fact that the board is responding to an appellant's argument.

[00:32:06] Speaker 02:
Full stop.

[00:32:08] Speaker 02:
You have to give notice.

[00:32:09] Speaker 02:
And you have to give a full and fair opportunity for the patent owner here to respond.

[00:32:13] Speaker 04:
Well, that's a little different from saying that any time the board responds to the patent owner's argument that it is a new ground of rejection.

[00:32:22] Speaker 04:
That means that's just that you can't have a new ground of rejection.

[00:32:25] Speaker 04:
simply by virtue of the fact.

[00:32:27] Speaker 02:
True.

[00:32:27] Speaker 02:
And again, that goes back to the thrust of the rejection.

[00:32:30] Speaker 02:
Has it changed?

[00:32:31] Speaker 02:
Has it fundamentally changed as it has here?

[00:32:33] Speaker 02:
We move from no reasonable expectation of success analysis to extracting new facts from the same references, which Biederman considered to be new grounds.

[00:32:43] Speaker 02:
And then the board went beyond just extracting new facts from the same references.

[00:32:47] Speaker 02:
They added references not discussed in the institution decisions at all, including a one on two way reference.

[00:32:53] Speaker 02:
providing Genzyme with absolutely no notice and absolutely no opportunity to respond, including swearing behind that reference, and that's the Kikuchi reference.

[00:33:07] Speaker 05:
Thank you Mr. Perko.

[00:33:08] Speaker 05:
The case is taken under submission.

[00:33:10] Speaker 02:
Thank you Your Honor.