[00:00:00] Speaker 04:
Number 20, 1158, N. Ray Samarin, Mr. Powell.

[00:00:08] Speaker 03:
Thank you, Your Honor.

[00:00:09] Speaker 03:
May it please the court?

[00:00:10] Speaker 03:
The first thing we should probably turn to is docket number 20.

[00:00:17] Speaker 03:
We have an unresolved motion to strike.

[00:00:22] Speaker 03:
We have a pair file from the Patent Office, the record of the

[00:00:29] Speaker 03:
before the agency below is 1,336 pages documentation.

[00:00:37] Speaker 03:
Here on appeal, the solicitor has tried to introduce 100 pages of new evidence that was not of record before the agency below.

[00:00:46] Speaker 03:
It does not appear anywhere in the electronic file.

[00:00:54] Speaker 03:
And so I've moved to strike that.

[00:00:57] Speaker 03:
Opposing counsel has

[00:01:00] Speaker 03:
So that's the first thing we should do is resolve whether we're going to grant or deny that motion to strike.

[00:01:11] Speaker 01:
Well, the opposition is predicated on the fact that the information was disclosed even if copies were not provided.

[00:01:19] Speaker 01:
Isn't that the argument on the other side?

[00:01:23] Speaker 03:
The opposition is premised on the idea that if a

[00:01:29] Speaker 03:
if an examiner after appeal to the board, if the examiner merely provides a citation to a reference, that that makes the reference of record.

[00:01:41] Speaker 03:
And there's a couple sort of problems that raises.

[00:01:45] Speaker 03:
One is if the examiner here, the examiner at the Board of Appeal withdrew all of the existing rejections and then on appeal after closing the record to new evidence, the examiner

[00:01:59] Speaker 03:
cited these new documents, that I could go on the internet, for example, and find those documents.

[00:02:07] Speaker 03:
But neither the examiner nor the board allows me to, at the board, introduce new evidence to rebut those.

[00:02:18] Speaker 04:
Wait a moment, Mr. Paul.

[00:02:20] Speaker 04:
As I understand the regulations under 41.39,

[00:02:26] Speaker 04:
the examiner can enter a new ground of rejection relying on new evidence.

[00:02:32] Speaker 04:
And then you have two options.

[00:02:34] Speaker 04:
You can elect to reopen prosecution or to maintain the appeal.

[00:02:39] Speaker 04:
And in this case, you elected not to reopen prosecution, which would have allowed you to introduce additional evidence.

[00:02:47] Speaker 04:
Instead, you decided to maintain the appeal.

[00:02:49] Speaker 04:
That's correct, right?

[00:02:52] Speaker 03:
That is procedurally correct.

[00:02:55] Speaker 03:
with a footnote that the regulation, 41.39, allows the examiner to make a new grounds of rejection on the evidence that's already of record but does not allow the examiner to introduce new evidence into the record on appeal.

[00:03:12] Speaker 04:
Well, that's just not correct.

[00:03:14] Speaker 04:
The regulation specifically contemplates new evidence being relied on on appeal by the examiner.

[00:03:22] Speaker 04:
That's why you're given the option to reopen.

[00:03:25] Speaker 04:
And the MPEP specifically talks about relying on new prior art that wasn't relied on before.

[00:03:34] Speaker 04:
And the examiner is permitted to do that, but it allows you to reopen prosecution if you wish to.

[00:03:39] Speaker 03:
And the problem with reopening prosecution is that if the office,

[00:03:55] Speaker 03:
reopens prosecution.

[00:03:57] Speaker 03:
Remember we had a delay between, we had a perhaps two years of delay between the time the examiner made a final office action and closed the record and the time the examiner raised this newly raised evidence.

[00:04:08] Speaker 03:
That's about roughly a two year delay.

[00:04:11] Speaker 03:
If the office at the Board of Appeals says we're sorry we perhaps made a mistake here, we at the office will reopen prosecution.

[00:04:22] Speaker 03:
I get that two years of

[00:04:23] Speaker 03:
delay added on to my client's patent term.

[00:04:26] Speaker 03:
So I haven't really, my client hasn't really lost anything.

[00:04:29] Speaker 03:
We've got some delay in issuing the patent, but we haven't actually had any of our 20 years of patent term waived.

[00:04:37] Speaker 03:
On the other hand, if I reopen prosecution, the rule is you get your patent term extended if the office makes a mistake.

[00:04:47] Speaker 03:
You don't get it extended if the applicant makes a mistake.

[00:04:51] Speaker 03:
And so if I reopen prosecution, one could argue, well, Mr. Pol, that means that you admitted that you made a mistake.

[00:04:59] Speaker 03:
And so you don't get the two years of delay added onto your patent term.

[00:05:05] Speaker 04:
Yeah, but there's no argument in this case about whether the patent term was correctly calculated.

[00:05:12] Speaker 03:
Exactly.

[00:05:17] Speaker 03:
I believe, sir, that your question behind the question is, why didn't I just reopen prosecution?

[00:05:26] Speaker 04:
Well, it's not a question of why you didn't.

[00:05:28] Speaker 04:
You had the opportunity to do that.

[00:05:30] Speaker 04:
And under the circumstances, the rules are clear that the examiner can rely on new prior art.

[00:05:39] Speaker 04:
And your choice, then, is to maintain the appeal or to reopen prosecution.

[00:05:44] Speaker 04:
You chose to maintain the appeal.

[00:05:47] Speaker 04:
So I don't understand how you can complain that he relied on new prior art.

[00:05:57] Speaker 03:
Because he's not allowed to introduce new evidence of record after closing prosecution.

[00:06:05] Speaker 03:
37 CFR 41.33 says you can't.

[00:06:12] Speaker 03:
There actually is.

[00:06:14] Speaker 03:
37 CFR 41.33.

[00:06:17] Speaker 03:
technically does allow new evidence after appeal, but only if the examiner finds that it resolves all of the rejections on appeal and allows the case to be allowed.

[00:06:40] Speaker 05:
So counselor, I don't understand your argument.

[00:06:44] Speaker 05:
You were at a point where you had an option

[00:06:47] Speaker 05:
you had a choice to make, and you're saying that you did not, you chose to not reopen the examination on the basis that you would lose out on your patent term.

[00:06:58] Speaker 05:
Is that correct?

[00:06:59] Speaker 03:
Exactly, sir.

[00:07:00] Speaker 03:
Thank you.

[00:07:13] Speaker 05:
Judge Dye, can we take this under advisement

[00:07:19] Speaker 04:
The motion to strike?

[00:07:21] Speaker 05:
Yes.

[00:07:22] Speaker 04:
Yes, that's what we should do.

[00:07:30] Speaker 03:
Okay.

[00:07:30] Speaker 03:
Okay, and then moving on to the merits, even assuming that Belmaceda, Ulysov, and all these, the prior artists that was not of record,

[00:07:49] Speaker 03:
during prosecution, even assuming that the court has jurisdiction to look at that.

[00:07:56] Speaker 03:
Taking the board at its word, and this is something that I tried to sort of be kind of clear in my writing is, I haven't actually quoted Balmaceda or Olasov.

[00:08:10] Speaker 03:
I've only quoted the board's, you would say, description of Balmaceda and Olasov.

[00:08:16] Speaker 03:
Taking the board at its word,

[00:08:19] Speaker 03:
Neither Balmaseeda nor Ulasav teaches a trans gene.

[00:08:22] Speaker 03:
A trans gene is, as the name, trans means different.

[00:08:26] Speaker 03:
Gene is something that expresses a protein.

[00:08:31] Speaker 03:
A trans gene is an RN gene, a gene taken from one organism and put into a different organism.

[00:08:37] Speaker 03:
The board says that Balmaseeda doesn't teach a trans gene, but Ulasav does.

[00:08:43] Speaker 03:
Ulasav, however, according to the board, Ulasav teaches

[00:08:47] Speaker 03:
getting an adenovirus, taking the E1A gene out of the adenovirus, placing a promoter onto it, and putting the E1A gene right back into the adenovirus right where you got it from in the first place.

[00:08:59] Speaker 03:
And so that is not a foreign gene in the adenovirus.

[00:09:04] Speaker 03:
That's an adenovirus gene put right back in the adenoviral genome where it first came from.

[00:09:09] Speaker 03:
So the artisan would not consider

[00:09:13] Speaker 03:
will solve as E1A to be a trans gene.

[00:09:17] Speaker 03:
They would consider it simply a gene.

[00:09:20] Speaker 03:
And we have a lot of the evidence, which is a record, that was a record during the prosecution, shows that.

[00:09:30] Speaker 03:
In response, the office has called.

[00:09:33] Speaker 04:
So why isn't this within the broadest reasonable interpretation of trans gene?

[00:09:41] Speaker 03:
I'm sorry again, Your Honor.

[00:09:43] Speaker 03:
Could you repeat?

[00:09:44] Speaker 04:
Why is this prior art not within the broadest reasonable interpretation of transgene?

[00:09:51] Speaker 03:
Because the prior art teaches a gene.

[00:09:55] Speaker 03:
It does not teach a transgene, a foreign gene put into a foreign organism.

[00:10:03] Speaker 04:
Yeah, but you're not addressing the claim construction.

[00:10:06] Speaker 03:
The claim requires a transgene.

[00:10:11] Speaker 03:
It doesn't simply require a gene.

[00:10:17] Speaker 03:
It requires a trans gene, a certain kind of a gene.

[00:10:21] Speaker 03:
A trans gene, the artisan knows is a, the artisan understands the term trans gene to be foreign.

[00:10:30] Speaker 03:
That's what the prefix trans means.

[00:10:39] Speaker 03:
the examiner in interpreting the claim term transgene to simply mean gene, that it aligns the prefix.

[00:10:54] Speaker 03:
And the artisan would not do that.

[00:11:01] Speaker 05:
This is Judge Rain.

[00:11:02] Speaker 05:
Your time may have run out, but I'd like for you real quickly to answer the question regarding

[00:11:07] Speaker 05:
teaching away and why you feel that the board did not get that correct?

[00:11:15] Speaker 03:
I don't know why the board didn't agree with it.

[00:11:26] Speaker 03:
Raynov is a record.

[00:11:29] Speaker 03:
I made a record in an information disclosure statement.

[00:11:32] Speaker 03:
Raynov has

[00:11:34] Speaker 03:
Very interesting article.

[00:11:35] Speaker 03:
He started out, he said, I'm going to see if there's any synergy between a... Let me get a little bit more specific with my question, counselor.

[00:11:46] Speaker 05:
It seems to me that you're arguing that the board didn't dispute the points that you raised with respect to teaching away.

[00:11:53] Speaker 03:
Correct.

[00:11:55] Speaker 05:
So you're saying that the board's silence on this particular issue was

[00:12:00] Speaker 05:
is there that we should accept your argument on that basis?

[00:12:07] Speaker 03:
You could accept my argument on that basis.

[00:12:10] Speaker 03:
Or if you want to be a little more thorough, you can actually read Raynhoff, because it is a record.

[00:12:15] Speaker 03:
And Raynhoff has two parts.

[00:12:18] Speaker 03:
The first part is in vitro testing of cells.

[00:12:22] Speaker 03:
And Raynhoff finds that in vitro, certain in vitro cell testing shows synergy, which would be

[00:12:28] Speaker 03:
you know, a good, a reasonable expectation.

[00:12:31] Speaker 05:
But not in vivo.

[00:12:34] Speaker 03:
Exactly.

[00:12:35] Speaker 03:
And that's sort of the trick of Raynov, is he did the in vitro, found there was synergy, then he did in vivo, and found that there was none.

[00:12:45] Speaker 03:
And so, you know, these skilled artists.

[00:12:49] Speaker 01:
Did he really find that there was none?

[00:12:51] Speaker 03:
Yeah, because he used the wrong kind of mice.

[00:12:55] Speaker 03:
The way that you get synergy here is,

[00:12:58] Speaker 03:
to have an active immune system.

[00:13:00] Speaker 03:
It's actually not the hemotherapeutic that's killing the cancer cells.

[00:13:03] Speaker 03:
It's the patient's killer T cells.

[00:13:06] Speaker 03:
And Raynov used nude mice that don't have killer T cells.

[00:13:13] Speaker 03:
So he didn't realize that the immune system was important to get synergy.

[00:13:19] Speaker 03:
So he used the wrong kind of mice.

[00:13:21] Speaker 01:
Is synergy even a limitation in the claim?

[00:13:24] Speaker 01:
I'm sorry?

[00:13:25] Speaker 01:
Is synergy even required by the claim?

[00:13:27] Speaker 03:
Synergy is not required by the claims, but synergy would be required for having an artisan read Reinoff and get a reasonable expectation of success to use that combination in humans.

[00:13:42] Speaker 04:
Yeah, except that the cases are very clear that the reasonable expectation of success is only addressed to claim limitation.

[00:13:49] Speaker 04:
So synergy is not a claim limitation, as you admit, then it's not part of the reasonable expectation of success.

[00:13:57] Speaker 03:
Well, the claim limitation that is in there is human.

[00:14:01] Speaker 03:
And that, of course, is in vivo.

[00:14:04] Speaker 03:
And so we do need to have a reasonable expectation of success for humans.

[00:14:12] Speaker 01:
Are you contending that you always have to have in vivo testing before you could have a reasonable expectation of success in humans?

[00:14:25] Speaker 03:
Frankly, it's even worse than that.

[00:14:28] Speaker 03:
The field of cancer research, we are banging our heads against the wall with mouse models that don't accurately reflect what goes on in the human.

[00:14:39] Speaker 03:
We spend all this money testing in mice.

[00:14:41] Speaker 03:
Works fine in mice.

[00:14:42] Speaker 03:
We try it in people.

[00:14:44] Speaker 03:
It fails.

[00:14:45] Speaker 03:
And so even more to the point,

[00:14:49] Speaker 03:
In the real world, and this I'm not sure that I'm talking in a legal concept so much as like what I see on a day-to-day basis in research laboratories and drug companies is scientists are just very frustrated because we have animal models that don't really reflect human reality.

[00:15:11] Speaker 04:
Yeah, but there's no evidence about that that you put in the record, right?

[00:15:15] Speaker 03:
No, no, no.

[00:15:15] Speaker 03:
That's one question, sir.

[00:15:21] Speaker 03:
The evidence we do have, however, says that for Raynov, specifically and for this specific combination, Raynov says this specific combination does not work in vivo.

[00:15:36] Speaker 04:
This is only concerns claim three, right?

[00:15:38] Speaker 04:
Because it's the only claim that talks about this combination there.

[00:15:42] Speaker 03:
Correct, sir, yes.

[00:15:46] Speaker 04:
OK, any further questions?

[00:15:51] Speaker 04:
Okay.

[00:15:52] Speaker 04:
Thank you, Mr. Powell.

[00:15:53] Speaker 04:
We'll give you two minutes for rebuttal.

[00:15:55] Speaker 04:
Ms.

[00:15:55] Speaker 04:
Nelson?

[00:15:57] Speaker 02:
Good morning, Your Honors.

[00:15:58] Speaker 02:
May it please the Court?

[00:15:59] Speaker 02:
I'll pick up first with the issue of the references not being of record, and let me just give a little background as to what happened here.

[00:16:06] Speaker 02:
The examiners did issue new grounds of rejections as she is entitled to do under Rule 41.39, and that is because the applicants introduced new evidence in the appeal brief, and so that

[00:16:21] Speaker 02:
that provision is in there for that very reason and i think that's exactly what happened here in fact there was a one thirty one declaration that was submitted to indicate one of the key references and that uh... is why i think that that uh... ten eighty of the record uh... and that's why the examiner issued the new grounds when the cameras should the new grounds at that point the appellant had a choice and as you've indicated they had a choice to either reopen prosecution order for to head with the appeal before the board and that's a choice they made

[00:16:51] Speaker 02:
and they did go forward with the board at the board and so they are limited to some extent in terms of what evidence they can present.

[00:17:02] Speaker 01:
That was a lot of new evidence though that the examiner put in, was it not?

[00:17:08] Speaker 02:
It was new grounds of rejection and in 2004 this rule came into place, 41.39 and the actual reason for that was that applicants

[00:17:18] Speaker 02:
oftentimes, not oftentimes, but sometimes, add new arguments or new evidence in their appeal brief, and then the examiner has no recourse to sort of address that, and at times they weren't even addressing it.

[00:17:34] Speaker 02:
And the important point is it gives the choice back to the applicant.

[00:17:39] Speaker 02:
So in this case, there was a 131 declaration that was submitted.

[00:17:43] Speaker 02:
They swore behind one of the key references, which then basically undid the grounds of rejection at play.

[00:17:49] Speaker 02:
The examiner then introduced new grounds.

[00:17:51] Speaker 02:
And of course, then the choice is for the applicant at that point.

[00:17:56] Speaker 02:
And so they chose to go forward with the board.

[00:17:58] Speaker 02:
They could have gone back examiner and done anything.

[00:18:03] Speaker 05:
Excuse me?

[00:18:04] Speaker 05:
This is Judge Raina.

[00:18:05] Speaker 05:
Do you agree that had they gone back to the examiner, that they would have been docked on their PTA?

[00:18:13] Speaker 02:
You know, I think the PTA, I don't know exactly the provisions.

[00:18:16] Speaker 02:
I don't have them.

[00:18:18] Speaker 02:
I don't know them by heart, but I believe if they prevail before the board, ultimately, then they would get some of that time back for the time that they were waiting before the board.

[00:18:30] Speaker 02:
So I don't think that's exactly accurate.

[00:18:33] Speaker 02:
But in any event, these references were of record by, as the board said, Hedgie, which is the only reference that was challenged

[00:18:43] Speaker 02:
before the board.

[00:18:45] Speaker 02:
The board properly found that the examiner, by making a full citation to it, complying with rule 104, that made that reference of record.

[00:18:54] Speaker 02:
And notably, U.S.

[00:18:55] Speaker 02:
patents to publish applications are not actually put into the file or provided to the applicant.

[00:19:00] Speaker 02:
They're still a record because they're part of the rejection.

[00:19:03] Speaker 02:
And to the extent that they didn't have access, which there's no indication that they didn't have access, there was a mechanism in the MPP for them to contact the examiner.

[00:19:11] Speaker 02:
The examiner could provide the reference

[00:19:13] Speaker 02:
and then reset the time period for reply.

[00:19:16] Speaker 02:
And obviously, with respect to the other references, their argument is waived and fails for the very same reason.

[00:19:25] Speaker 02:
If there's no question until then, I'll move on to the transgene issue.

[00:19:29] Speaker 02:
So with respect to the transgene, here what we have is a limitation that is not defined in the specification.

[00:19:36] Speaker 05:
Let's go back just real quickly back to that, to the other issue.

[00:19:42] Speaker 05:
Okay.

[00:19:43] Speaker 05:
Yeah.

[00:19:43] Speaker 05:
The government's position with respect to patent term adjustment where the entity is facing new grounds and a slew of new evidence like they have in this case.

[00:19:56] Speaker 05:
And now we're being told that if they say, well, we're going to seek to reopen the exam in order to address everything, then that's going to have an adverse impact on

[00:20:08] Speaker 05:
on the patent term because they're going to be viewed as having delayed the process.

[00:20:16] Speaker 05:
What's the government's position on that?

[00:20:18] Speaker 05:
If the government introduces a new grounds and new evidence, why should that have an adverse impact on the patent term?

[00:20:29] Speaker 02:
It doesn't have an adverse impact on the patent term.

[00:20:34] Speaker 02:
The examiner made the rejection

[00:20:37] Speaker 02:
within the time period that's allowed, then the applicant has its time period to respond.

[00:20:42] Speaker 02:
And assuming they stay within their time period, there's going to be no effect on patent term at the end of the day.

[00:20:48] Speaker 02:
But more importantly here, it's about choices and about getting the record ready for appeal.

[00:20:55] Speaker 02:
And here we have a situation where evidence, in fact, the applicant themselves brought in new evidence in their appeal brief.

[00:21:02] Speaker 02:
And so it really wasn't a closed record at that point.

[00:21:05] Speaker 02:
So the examiner had needed to respond to that, and they did.

[00:21:09] Speaker 02:
And at that point, the applicant had a choice to continue with prosecution to write a response to that rejection and get the record ready for appeal.

[00:21:23] Speaker 02:
Typically, things should be sealed up and closed before they go on appeal.

[00:21:27] Speaker 02:
And here what we had was some lingering issues that hadn't been resolved.

[00:21:30] Speaker 02:
And it was perfectly appropriate for the examiner to open

[00:21:33] Speaker 02:
not open, I mean, to issue the new grounds in response to the new issues that were raised in the appeal brief.

[00:21:41] Speaker 01:
Council, can we turn to Reduction Number 3 and Reinoff?

[00:21:47] Speaker 01:
As I see the board, the board addresses the question of teaching away, but never proceeds to say, even if it doesn't completely teach away,

[00:22:00] Speaker 01:
that it doesn't completely teach away, and it also provides a reasonable expectation of success from the combination.

[00:22:11] Speaker 01:
It's the latter part of the analysis that seems completely missing from the board's opinion.

[00:22:20] Speaker 02:
I mean, I understand what the board was saying here.

[00:22:23] Speaker 02:
Let me just pull to the relevant section.

[00:22:25] Speaker 01:
All it really says is that Raynoff

[00:22:30] Speaker 01:
says that the combination would justify further investigation?

[00:22:37] Speaker 02:
Right.

[00:22:38] Speaker 02:
Well, Raynov says a number of things.

[00:22:40] Speaker 02:
If I can first just sort of briefly say what Raynov teaches.

[00:22:43] Speaker 02:
And first, it does show synergy in Table 1.

[00:22:48] Speaker 04:
Just one second.

[00:22:49] Speaker 04:
Before we go on that, this only applies to Claim 3, because only Claim 3 involves this combination therapy, right?

[00:22:57] Speaker 02:
I believe Claim, I think Claim

[00:22:59] Speaker 02:
42 might as well.

[00:23:02] Speaker 02:
I know it's Rejection 3, but let me... It's Rejection 3.

[00:23:06] Speaker 02:
There's several counts.

[00:23:07] Speaker 02:
There's several.

[00:23:07] Speaker 04:
It's... No, but it's only Claim 3.

[00:23:09] Speaker 02:
It was Claim 3 as a combination.

[00:23:15] Speaker 02:
Yes, it's only Claim 3.

[00:23:17] Speaker 02:
You're correct.

[00:23:19] Speaker 02:
Yeah, there were several... There were multiple claims in the rejection, but with respect to the combination, it only affects Claim 3.

[00:23:28] Speaker 02:
And what Raynoff does, it teaches several things.

[00:23:31] Speaker 02:
It teaches first in vitro that there is synergy between the GCV and TMZ, and that's in Table 1.

[00:23:39] Speaker 02:
And then in vitro, it looks at tumor size and tumor weight, and this is in Figures 2 and 3.

[00:23:45] Speaker 02:
And it shows that each of the treatments, TMZ alone, GCV, or the combination all have effect in reducing tumor size and tumor weight.

[00:23:53] Speaker 02:
it actually showed a statistically significant difference between TMZ and the combination.

[00:23:58] Speaker 02:
Well, that's interesting, but the board doesn't say any of that, does it?

[00:24:02] Speaker 02:
The board just basically went ahead and acknowledged what they had said, which is the key point that I think the appellants were making, was that there was no significant difference disclosed between TMZ and the combination.

[00:24:17] Speaker 02:
And so the board's response to that was, yeah, okay, so even if

[00:24:21] Speaker 02:
even if they haven't disclosed synergy in the combination as compared to TMG, they still teach other benefits, and that's where they point to page 299 of the record, where Reinoff talks about other benefits, clinical implications of the combination, which include reduced toxicity towards the host and decreased impact of acquired drug resistance.

[00:24:45] Speaker 02:
So the board says even that alone would direct one to

[00:24:51] Speaker 02:
to pursue the combination.

[00:24:53] Speaker 02:
And notably, I mean, this isn't a case where it's criticizing or discouraging or otherwise discrediting use of the combination.

[00:25:00] Speaker 02:
In fact, the final paragraph does suggest it summarizes the data and talks about the demonstration of synergy between the combination and talks about it as an enhanced therapeutic concept for future studies in human malignant glioma.

[00:25:14] Speaker 02:
It's really directing one of skill and the art to that combination.

[00:25:18] Speaker 02:
And as the panelists have indicated, the claims don't actually require synergy, and nor does the application actually disclose synergy.

[00:25:26] Speaker 02:
The only disclosure is on page 69 of the record.

[00:25:30] Speaker 02:
And there's one example which describes really in text that it talks about one group having the biggest decrease in tumor size and other group having, with the combination, having the longest survival rate.

[00:25:43] Speaker 02:
There's no comparison to either of them alone, GCV or TMZ alone.

[00:25:48] Speaker 02:
And no numbers, no data.

[00:25:51] Speaker 04:
On the combination therapy in claim three, is it not the case that Rubinoff shows that the combination therapy in vivo is superior to the placebo?

[00:26:14] Speaker 02:
Yes, compared to the placebo, yes.

[00:26:22] Speaker 02:
If that's what you're, yeah.

[00:26:29] Speaker 04:
OK, are there further questions?

[00:26:34] Speaker 02:
No.

[00:26:35] Speaker 04:
OK.

[00:26:36] Speaker 02:
And if you, I'd be happy to address transgene if you have any issues on that.

[00:26:42] Speaker 04:
Do my colleagues have any transgene questions?

[00:26:45] Speaker 02:
No.

[00:26:48] Speaker 02:
Okay.

[00:26:48] Speaker 02:
Then I'm happy to see the remainder of my time.

[00:26:51] Speaker 02:
I ask that you affirm the board's decision.

[00:26:53] Speaker 04:
Thank you, Ms.

[00:26:54] Speaker 04:
Nelson.

[00:26:55] Speaker 04:
Mr. Paul, you have two minutes.

[00:26:58] Speaker 03:
In closing, the... Assuming that I could have reopened prosecution or assuming that the examiner could have reopened prosecution at the board,

[00:27:18] Speaker 03:
That's one issue.

[00:27:20] Speaker 03:
Another issue that this court has got to consider is 35 USC section 144, which I believe defines the jurisdiction of this court.

[00:27:31] Speaker 03:
And so regardless of whether the examiner or I elect to reopen prosecution or not, I think the jurisdiction of this court is limited to the

[00:27:42] Speaker 03:
record before the Patent and Trademark Office.

[00:27:45] Speaker 03:
And I think everyone here agrees that the 100 pages of new evidence that opposing counsel has presented to this court do not appear in the record before the agency.

[00:27:58] Speaker 05:
Counselor, this is Judge Graydon.

[00:27:59] Speaker 05:
That may be true, but the examiner did give full scientific citation for each one of those references.

[00:28:07] Speaker 00:
Correct.

[00:28:07] Speaker 05:
And the way to do this, I think that

[00:28:09] Speaker 05:
That gave you a sufficient basis.

[00:28:12] Speaker 05:
That gave you notice as to what you seek to respond to the new objection.

[00:28:21] Speaker 05:
I don't know that it seems to me that the ball was in your court.

[00:28:30] Speaker 05:
And you chose to not follow the regulations and even our case law in this regard.

[00:28:40] Speaker 05:
We did state the reasons and we didn't follow up, so.

[00:28:47] Speaker 03:
Not to follow the regulations.

[00:28:55] Speaker 03:
Such as?

[00:28:56] Speaker 03:
I'm curious.

[00:28:59] Speaker 05:
Well, look at CFR 1.104D1.

[00:29:05] Speaker 05:
And I imagine we're going to respond to this in more detail.

[00:29:11] Speaker 03:
Okay.

[00:29:21] Speaker 03:
All right.

[00:29:22] Speaker 03:
If there are no further questions, then I'll rest.

[00:29:30] Speaker 04:
Okay.

[00:29:30] Speaker 04:
Hearing no further questions, thank you, Mr. Paul.

[00:29:33] Speaker 04:
Thank you, Ms.

[00:29:33] Speaker 04:
Nelson.

[00:29:34] Speaker 04:
The case is submitted.

[00:29:36] Speaker 03:
Thank you.

[00:29:40] Speaker 02:
The honorable court is adjourned until tomorrow morning at 10 a.m.