[00:00:00] Speaker 00:
171257, Inray Jansen, BioTech.

[00:00:28] Speaker 00:
Let's make sure we're all ready.

[00:00:48] Speaker 00:
Okay, so this is going to sound familiar, I guess, but why don't you proceed.

[00:00:53] Speaker 04:
May it please the court.

[00:00:55] Speaker 04:
The board's denial of safe harbor protection should be reversed because it is premised on two fundamental errors that drastically shrink eligibility for the safe harbor and distort this court's constant test.

[00:01:12] Speaker 04:
First, the board erred in creating its divisional as filed test, even though that requirement

[00:01:21] Speaker 03:
At what precise point in time do you assert that the 471 patent transformed from being CIP application of 413 and 406 applications to instead a divisional in substance application?

[00:01:37] Speaker 03:
What specific time?

[00:01:39] Speaker 04:
There were two specific actions during the prosecution where Jansen... Is it May or December?

[00:01:48] Speaker 04:
Well, in the preliminary amendment, they certainly signaled that because they told the examiner that they were proceeding out of deference to the restriction requirement in the 413 parent, they were deleting the claims

[00:02:12] Speaker 04:
that were directed to the methods of treatment.

[00:02:15] Speaker 04:
The methods of treatment, of course, were the group four claims that were elected in the parent and the reference patents.

[00:02:23] Speaker 04:
So in the preliminary amendment, they took out those claims.

[00:02:31] Speaker 04:
And then in the election of species requirement, of course, they took out the claims that were solely supported by the 406 patent.

[00:02:42] Speaker 04:
Most critically, in the amendment, the Section 129 amendment, they came back and they explained that they were entitled to Section 121 safe harbor protection because they had canceled the relevant claims in the 093 application and they had canceled in the other application.

[00:03:08] Speaker 03:
So is it December 95 then?

[00:03:11] Speaker 04:
Well, it's a combination of those, Your Honor.

[00:03:14] Speaker 04:
They could... That has to be a date.

[00:03:17] Speaker 04:
Well, certainly by December 95, they had done that.

[00:03:21] Speaker 04:
And it was those two... Or excuse me, by December 1994, the preliminary amendment signaled that.

[00:03:30] Speaker 04:
And then in May 8, 1997, that amendment signaled it again.

[00:03:34] Speaker 04:
And at that point, there was no question that they were entitled to that

[00:03:40] Speaker 04:
safe harbor protection because the examiner granted them that protection consistent with the practice at the time.

[00:03:50] Speaker 04:
Remember, we showed that evidence

[00:03:52] Speaker 04:
that there were many patents where the patent office had treated applications as both CIPs and divisionals.

[00:04:00] Speaker 04:
We showed 34 examples of that.

[00:04:03] Speaker 04:
And we showed the MarTech re-examination, where the patent office had treated an application as a CIP application as a divisional.

[00:04:13] Speaker 04:
In fact, the re-examination had re-designated it as a divisional, in frank and safe order protection.

[00:04:20] Speaker 04:
That was the practice at the time.

[00:04:22] Speaker 04:
But what the argument has been is that no, that was not the practice at the time.

[00:04:27] Speaker 04:
And my colleague had cited an official gazette notice that said one shouldn't treat a CIP as a divisional, but that was years after, or 18 months after at least,

[00:04:42] Speaker 04:
In that case, the grant of the 471 patent, where both Jansen and the examiner, consistent with the practice at the time, had treated that application as both a continuation in part and a divisional.

[00:04:56] Speaker 04:
And it was he that Jansen respected that divisional treatment by not claiming the added subject matter that was in there that made it a CIP.

[00:05:09] Speaker 01:
Was that undertaken solely for procedural purposes?

[00:05:14] Speaker 04:
No, they were giving that added disclosure to the public without claiming it.

[00:05:22] Speaker 04:
Now, when on the day that patent application was filed, there were claims to that additional subject matter.

[00:05:29] Speaker 04:
But Jansen deleted those claims during prosecution before it requested to save our protection.

[00:05:37] Speaker 04:
So throughout the prosecution, Jansen and the examiner both treated this effectively as... Let's go back a little bit.

[00:05:47] Speaker 01:
You say throughout the prosecution.

[00:05:50] Speaker 01:
But I don't think there's any dispute that the 471 panel is filed as a continuation in part, correct?

[00:05:56] Speaker 04:
That's correct.

[00:05:58] Speaker 01:
Okay.

[00:05:58] Speaker 01:
And there's no dispute either that the 471 pan contained new disclosures in a new manner that was not found in the 413th pan.

[00:06:08] Speaker 04:
That's correct.

[00:06:09] Speaker 01:
So, the formate substance, you're looking at a division.

[00:06:14] Speaker 04:
In substance, we're looking at both because it was originally truly in substance a continuation in part, but then Jansen came in in those two events, first in December 1994 in the preliminary amendment, they cut out all of the claims

[00:06:32] Speaker 04:
that were not constant, all the method of treatment claims.

[00:06:35] Speaker 04:
And then, in the May 8, 1997 amendment, when previously all of the claims that were not supported by the 413 parent had been removed, they came in and said, we are entitled to the safe harbor protection.

[00:06:52] Speaker 04:
At that point,

[00:06:53] Speaker 04:
It was effectively a divisional.

[00:06:56] Speaker 04:
The examiner recognized that by granting the safe harbor protection.

[00:07:00] Speaker 04:
The examiner cited the fact that the claims were now distinct between the 093 application and the 799 application that issued as the 195.

[00:07:12] Speaker 04:
So truly, throughout the prosecution, Jansen was making it clear both to the examiner and to the public that this was a divisional.

[00:07:21] Speaker 04:
So in reexamination, when they changed the designation from CIP to divisional, they were changing the fundamental nature of the application.

[00:07:33] Speaker 04:
They were simply correcting the designation.

[00:07:36] Speaker 03:
In the red brief, the USPTO at 34 and 35 says,

[00:07:40] Speaker 03:
that you mischaracterized the PTAP's 2013 re-exam decision when you stated the examiner authorized Janssen's amendment, authorized in quotes, and thus, quote, the amendments have effectively designated the 093 application a divisional of the parent application, close quote.

[00:08:06] Speaker 04:
Was this a misrepresentation?

[00:08:13] Speaker 03:
Where in the JA can you show us the PTO expressly referring to 093 or 471 as divisional?

[00:08:22] Speaker 04:
Well, when the office directed the entry of these amendments.

[00:08:29] Speaker 04:
I mean, there is no question that Jansen petitioned for the entry of the amendments, and the office granted those amendments.

[00:08:41] Speaker 04:
What the examiner is doing is raising a red herring.

[00:08:44] Speaker 04:
What they're saying is there's no dispute about that at the office granting the petition.

[00:08:50] Speaker 04:
The dispute is about what the effect is of that.

[00:08:54] Speaker 04:
Their argument is really that the order granting the petition did not resolve the substantive issue of whether such amendment would be effective to alter the nature of the patent under reexamination.

[00:09:07] Speaker 04:
So in other words, what the examiners are saying is the director granted the petition but that doesn't resolve the issue.

[00:09:17] Speaker 04:
It doesn't resolve the issue of whether your amendment to

[00:09:22] Speaker 04:
to designate this officially a divisional answers the question.

[00:09:27] Speaker 04:
And really what they're looking at there is not compliance with the statute, because we convinced the director that we were complying with the statute.

[00:09:39] Speaker 04:
Their argument there was that this court's cases, like Searle, prevented that from being effective, when that's just simply not the case.

[00:09:49] Speaker 04:
Your Honor, you asked for a specific JA site, and that site would be really the order granting the petition, and I'll find that for you.

[00:10:06] Speaker 04:
You don't have to.

[00:10:09] Speaker 04:
OK.

[00:10:10] Speaker 04:
Then it's 1117 through 1134.

[00:10:14] Speaker 04:
So what's the argument there?

[00:10:15] Speaker 04:
And we believe it's a red.

[00:10:17] Speaker 03:
Is 413 the parent application?

[00:10:19] Speaker 04:
Yes.

[00:10:20] Speaker 03:
What about 406?

[00:10:21] Speaker 04:
The 406 was a parent application, and it was a parent application with respect to the added matter, or what DeGrader referred to as the new matter.

[00:10:33] Speaker 04:
So the 406 was a parent application for the added matter.

[00:10:38] Speaker 04:
That added matter was never claimed.

[00:10:40] Speaker 04:
in the 417 patent and the added matter was removed and the priority claim was removed in the re-examination to the 416 patent.

[00:10:55] Speaker 04:
So the assertion by the examiners is really kind of nitpicking there.

[00:11:03] Speaker 04:
What they're saying is, despite the entry of that amendment, that it doesn't take effect until the certificate issues.

[00:11:15] Speaker 04:
And we've heard that from our colleague in the previous argument.

[00:11:19] Speaker 04:
But it's very clear in the statute

[00:11:21] Speaker 04:
that the office is to treat that, or excuse me, it's clear in the regulation that the office is to treat that as if it had been entered.

[00:11:30] Speaker 04:
And so in this appeal, we are proceeding as if that amendment had been entered.

[00:11:36] Speaker 04:
And this, in fact, has been re-designated as a divisional.

[00:11:41] Speaker 04:
But returning to your original question, Judge Wallach,

[00:11:45] Speaker 04:
Jansen's belief is its signal to the examiner, to the public, early and throughout the original examination that this was being treated as a divisional, entitled to the state harbor.

[00:11:58] Speaker 04:
And that simply, in reexamination, Jansen simply redesignated that to formally designate that as a divisional.

[00:12:09] Speaker 04:
But what I was pointing out originally is that there are two fundamental errors that the board made.

[00:12:16] Speaker 04:
And the first was in this divisional as filed requirement.

[00:12:19] Speaker 04:
There is no basis for that requirement in section 121.

[00:12:24] Speaker 04:
And that requirement flatly contradicts, flatly conflicts with the PTO's practice under section 120, allowing an applicant to file

[00:12:35] Speaker 04:
a continuation and then come in and amend that to divisional status.

[00:12:42] Speaker 04:
We have never heard from the board or from the PTO how they could be making this divisional as filed argument, which is a completely new rule, not supported by the statute of this court's case law.

[00:12:55] Speaker 04:
When it flies in the face of that practice,

[00:12:58] Speaker 04:
For decades, patentees have been filing applications as continuations and later coming in and re-designating those as divisionals.

[00:13:10] Speaker 04:
And there's no more.

[00:13:12] Speaker 00:
When you say continuations, you mean continuations in part?

[00:13:14] Speaker 00:
Or continuations.

[00:13:15] Speaker 04:
Or continuations in part.

[00:13:16] Speaker 00:
And coming in and- So your statement is for years, they've designated them as continuations in part and then changed them to divisionals.

[00:13:26] Speaker 04:
office is accepted that i'm i'm saying two things that one for years they filed them as continuations and later changed them as divisionals and then for years they filed them as continuations and designated them as continuations in part and divisionals in other words there are there are both but the practice that's very common is filing continuations

[00:13:51] Speaker 04:
and later coming in.

[00:13:53] Speaker 00:
Okay, I was still a little confused.

[00:13:55] Speaker 00:
My question is, is there a practice of filing them as continuations in part and then allowing people to come in and recast them as divisionals?

[00:14:05] Speaker 04:
Yes, the 34 patents that we have shown have been designated as both continuations in part and divisionals.

[00:14:15] Speaker 04:
But the practice that I was referring to is the one that's very common of simply filing continuation with the same disclosure and later complying with the requirement that they be called divisionals.

[00:14:32] Speaker 04:
And so what that shows is that the divisional as filed requirement isn't something that's consistent with PTO practice.

[00:14:44] Speaker 04:
And so it goes back to Judge Warneman's policy argument from the last case, where he was asking about what is the policy, here's the policy unjustified extension.

[00:15:00] Speaker 04:
know that Congress trumped that policy with Section 121 when it looked at fairness to the patentee that had been forced to prosecute applications on different inventions in separate applications.

[00:15:16] Speaker 04:
And that's what happened here.

[00:15:18] Speaker 04:
There's no question there was a restriction requirement in the parent.

[00:15:22] Speaker 04:
And Congress said in that case, we have section 121.

[00:15:28] Speaker 04:
And this was an instance that implicates another policy that we pointed out.

[00:15:33] Speaker 01:
Let's go back to the question I asked you about whether

[00:15:35] Speaker 01:
the amendment that you rely on, if that was procedural informed, because it seems to me that it is.

[00:15:43] Speaker 01:
And if it is, then I think that you lose.

[00:15:46] Speaker 01:
I don't see that the PTO took the action that you say that it did, that it granted the motion to amend for purposes of what ultimately resulted to be a divisional patent.

[00:16:03] Speaker 01:
They granted a

[00:16:06] Speaker 01:
the motion for a direct entry of amendments and they did it for re-examination purposes only so that they could send the patent back or the re-exam back to the office for final action, correct?

[00:16:19] Speaker 01:
So I don't see this

[00:16:26] Speaker 01:
character changing the event that took place with respect to the amendment.

[00:16:31] Speaker 01:
Can you just briefly focus on that?

[00:16:33] Speaker 04:
Sure.

[00:16:35] Speaker 04:
We're not saying that that petition resolved, that the grant of that petition resolved all the issues.

[00:16:42] Speaker 04:
What we're saying is the director in granting that petition recognized that Janssen had complied with the statutes and regulations that allowed it to, in this reexamination, formally designate as a divisional an application

[00:17:00] Speaker 04:
that both Jansen and the examiner throughout the original prosecution had treated as a divisional and that that was consistent with the practice of the time and as a result Jansen had an expectation

[00:17:16] Speaker 04:
that of the kind that the Supreme Court in Festa said, this court should not be creating bright line rules that destroy the expectations of patentees.

[00:17:26] Speaker 01:
But you were not granted an amendment, you were not granted a motion to amend, to redesignate the patent.

[00:17:33] Speaker 04:
We were granted a petition to enter amendments, one of many amendments.

[00:17:40] Speaker 01:
But you were not granted a motion to redesignate the patent.

[00:17:44] Speaker 04:
If it wasn't a motion, it was a petition.

[00:17:46] Speaker 01:
Or a petition.

[00:17:47] Speaker 04:
And the petition was to amend the application.

[00:17:51] Speaker 01:
Okay, I get that.

[00:17:52] Speaker 01:
But again, you are not granted a petition to redesignate the patent.

[00:17:58] Speaker 04:
I think we're, I'm missing the point of that.

[00:18:04] Speaker 01:
Well, I recognize the point that this amendment process took place.

[00:18:08] Speaker 01:
I just don't see the basis for it that you argue with.

[00:18:13] Speaker 01:
I see that what happened was pretty procedurally informed and did not have the effect of redesignating the patent.

[00:18:23] Speaker 04:
Well, it has had the effect of amending the patent application, so it is now a divisional.

[00:18:32] Speaker 04:
And the question is, what is the effect of that?

[00:18:35] Speaker 04:
And the question is, is that effective in this case to allow application of the safe harbor protection?

[00:18:45] Speaker 04:
So I think we might be missing each other on terminology.

[00:18:50] Speaker 04:
And I think the answer is that the grand entry of the amendments, the grand petition, was a recognition that Janus complies with the statute of consulence.

[00:19:05] Speaker 04:
I see my time is up.

[00:19:06] Speaker 00:
Well, why don't you stay here, because Judge Rayna had a question, or perhaps even more.

[00:19:09] Speaker 01:
Can you address briefly the issue of consulence?

[00:19:13] Speaker 04:
Yes, the consonants, certainly.

[00:19:27] Speaker 04:
The board cared in holding that the 471 and one of the records patents violated consonants.

[00:19:36] Speaker 04:
The CTO is arguing here now that all three of the patents violated consonants because the claims were not limited to TNF alpha.

[00:19:45] Speaker 04:
That's not clear that that was the board decision, but let's talk about

[00:19:51] Speaker 04:
was the simple fact that there is no dispute that this court's confidence test is whether the issued claims, the issued claims of these three patents crossed the line of demarcation that was set out in the parent application's restriction requirement.

[00:20:06] Speaker 04:
That line of demarcation was between the group, four claims,

[00:20:11] Speaker 04:
that the parent and the reference patents prosecuted.

[00:20:17] Speaker 04:
That's the method of treatment claims.

[00:20:19] Speaker 04:
And here we have the antibody and assay claims, what have been referred to as the antibody claims of group one.

[00:20:27] Speaker 04:
It's very clear that all of the claims of the 471 are Group 1 claims.

[00:20:36] Speaker 04:
There's no treatment method claims.

[00:20:38] Speaker 04:
Those were cancelled in the preliminary amendment.

[00:20:41] Speaker 04:
And it's likewise very clear that all of the claims in the reference patents are method of treatment claims.

[00:20:47] Speaker 04:
Under this court's test,

[00:20:50] Speaker 04:
That is the end of the analysis of consonants.

[00:20:54] Speaker 04:
We don't look for consonants at claims that may have been during the prosecution.

[00:20:59] Speaker 04:
And we don't look at the claims that were pending in the period at the time that may have referred to TNF alpha.

[00:21:08] Speaker 04:
And that's the argument that we're seeing here is that they're not consonant because they don't specifically require TNF alpha.

[00:21:17] Speaker 01:
So the continence ground, that was an alternative ground by the board, right?

[00:21:23] Speaker 01:
So if we affirm on the safe harbor issue, we don't have to reach this particular issue.

[00:21:29] Speaker 04:
You do not have to reach continence because the board relied on its divisional as filed requirement to say on the date of filing,

[00:21:42] Speaker 04:
The description has to be divisional.

[00:21:46] Speaker 04:
The claims have to be...

[00:21:48] Speaker 04:
consonant and the written description has to be based solely on that of the parent.

[00:21:57] Speaker 04:
And that is a requirement that finds no basis in the statute and flat out conflicts with the PAC office's policy under Section 120.

[00:22:09] Speaker 00:
Thank you.

[00:22:09] Speaker 00:
We'll restore two minutes of rebuttal and let's hear from the government.

[00:22:18] Speaker 02:
Can you try to speak into the microphone?

[00:22:29] Speaker 00:
I'm sorry.

[00:22:30] Speaker 02:
In 1994, Janssen made the inevitable choice to file the O-9 Korea application as a CIP application.

[00:22:39] Speaker 02:
They told the USPTO in three separate papers that it was filing it as a CIP application.

[00:22:46] Speaker 02:
By choosing to do so, Janssen chose to forego falling under the safe harbor, and nothing that the examiner or Janssen did during the prosecution.

[00:22:54] Speaker 01:
Counsel, is this really a broad-line test that we should adopt?

[00:22:58] Speaker 01:
that if you file your application and it's designated as such as a CIP, that nothing can ever happen in the course of the proceedings to change it into a division.

[00:23:13] Speaker 02:
I think it is a bright line of the room, Your Honor.

[00:23:16] Speaker 02:
And if you look at your case law, it's based on statutory construction that it has to be a divisional as filed.

[00:23:23] Speaker 02:
And Janssen here tries to make equity arguments.

[00:23:25] Speaker 02:
It tries to talk about it.

[00:23:26] Speaker 00:
But don't they also, and maybe you can clarify for me, because I wasn't really understanding it thoroughly, that representation was made that it's the office's practice to allow one to change from continuations to divisional.

[00:23:39] Speaker 00:
and some suggestion that that includes CIPs under certain circumstances.

[00:23:44] Speaker 00:
Can you explain if that is their policy?

[00:23:47] Speaker 03:
And while you're betting cleanup, I was going to ask your opposing counsel about Amgen and Searle and why it didn't just blow them out.

[00:23:54] Speaker 02:
You've got three people to respond to.

[00:24:11] Speaker 02:
are completely different, right?

[00:24:13] Speaker 00:
And when you file a CIP... So you're saying to Judge Raina, there is a bright line?

[00:24:17] Speaker 02:
Yes, for CIP, definitely.

[00:24:20] Speaker 02:
And, you know, there are practices where you can amend and change your benefit plan, but I am not aware of the office ever allowing anyone to change a CIP into a division.

[00:24:33] Speaker 01:
I know the office hasn't allowed it.

[00:24:35] Speaker 01:
The question is whether we should allow it.

[00:24:37] Speaker 01:
And whether we should actually adopt a bright-line test.

[00:24:41] Speaker 01:
We're kind of leery right now of bright-line tests.

[00:24:44] Speaker 01:
You may have heard.

[00:24:45] Speaker 01:
But they serve the purpose.

[00:24:49] Speaker 01:
And this may be one of them.

[00:24:51] Speaker 01:
And so that's why I asked you for your argument on that.

[00:24:54] Speaker 02:
Right.

[00:24:55] Speaker 02:
And so as this court held, it was a statutory construction of 121 that it meant divisional as filed.

[00:25:03] Speaker 02:
And you said it in three different cases.

[00:25:05] Speaker 02:
You said it in Pfizer.

[00:25:06] Speaker 02:
You said it in Amgen.

[00:25:07] Speaker 02:
And you said it in Searle, saying you can't go back and retroactively change it as filed.

[00:25:13] Speaker 02:
You know, there are certain things in prosecution you can fix.

[00:25:16] Speaker 02:
There are other things in prosecution you can't fix.

[00:25:19] Speaker 02:
And if you made a choice, and there's no suggestion that this was a mistake, they, unequivocally, made the choice to file the CIP.

[00:25:28] Speaker 02:
And according to the peaceful, that's the end of the story.

[00:25:32] Speaker 00:
And what's the policy behind that?

[00:25:35] Speaker 00:
Why?

[00:25:36] Speaker 00:
Why shouldn't they be able to, at some point, change course?

[00:25:42] Speaker 02:
First of all, when you file an application, you're putting the public on notice of what that type of application is so there's a notice function.

[00:25:50] Speaker 02:
You're also telling the office something.

[00:25:52] Speaker 02:
If you file a CIP, you're informing the office that there's additional matter, that your claims may go to that additional matter, that all of those claims might not have supported the priority application.

[00:26:03] Speaker 02:
So there's a lot of notice function to both the public and to the office in order to make the office's job more efficient.

[00:26:11] Speaker 00:
If they amend it, then there's notice given by the amendment.

[00:26:15] Speaker 02:
There's notice given by the amendment, but according to 121, it has to be a divisionless file.

[00:26:20] Speaker 02:
It's very clear that changing it after the case doesn't really

[00:26:32] Speaker 02:
I think there's no reason to allow someone to do that.

[00:26:34] Speaker 02:
If Jansen had wanted to file a divisional, they could have filed a divisional as a separate application.

[00:26:40] Speaker 02:
They could have done that before those other records patented and issued, and they chose not to do so.

[00:26:46] Speaker 02:
Instead, they prosecuted this as a CIP alter prosecution.

[00:26:49] Speaker 01:
So if they have an easy way out, if there is a way of doing it outside by initiating the application, then why go through all that trouble?

[00:26:58] Speaker 01:
Why not recognize that there may be a point in time

[00:27:01] Speaker 01:
in the application process that a continuation in part can turn divisional.

[00:27:10] Speaker 01:
Okay, you may not have heard.

[00:27:13] Speaker 01:
It seems to me that you're saying that they could have taken action at a later time, but filed them as a divisional.

[00:27:20] Speaker 01:
A separate application.

[00:27:24] Speaker 01:
So if there's a way out, and that's a way out to do this, then why have a broad-line test?

[00:27:30] Speaker 01:
Why not create or recognize that there's a point in the proceeding

[00:27:35] Speaker 01:
in the application process that a CIP can turn divisional.

[00:27:42] Speaker 02:
Because a CIP is filed as a CIP and has all this extra subject matter in it.

[00:27:47] Speaker 02:
Like I'm saying, if they wanted a divisional application, not a separate application that they could have filed.

[00:27:54] Speaker 02:
But the office, as far as I'm aware, and they haven't pointed to any instances, we do not change CIPs during prosecution into divisionals as a matter

[00:28:04] Speaker 01:
What about your opponent's argument that you didn't cause a change to happen when you granted their petition for amendment?

[00:28:13] Speaker 02:
So that was a great petition.

[00:28:16] Speaker 02:
And so the office entered petition, you know, granted the petition for formal reasons to allow the issue to come to the board.

[00:28:25] Speaker 02:
And what the examiner did in the advisory action, which is at 862 to 863, is he says, even in light of the petition being granted, I am still maintaining my Augustus-type double packing projection so we could go to the board and all.

[00:28:45] Speaker 01:
The examiner said that, and the board approved that.

[00:28:49] Speaker 02:
And so then it went to the board, and then the board was able to address the merits of the issue.

[00:28:57] Speaker 02:
So the amendments aren't final until a re-exam certificate is issued.

[00:29:04] Speaker 01:
So your view seems to be consistent with mine that the petition process at the moment that we're talking about, that that was for procedural purposes only?

[00:29:11] Speaker 02:
Correct.

[00:29:13] Speaker 02:
It was to allow the issue to be raised in on the merits to the board.

[00:29:19] Speaker 00:
And what about Judge Rainer raised the issue of consonants?

[00:29:24] Speaker 00:
in fact, an alternative ground.

[00:29:25] Speaker 00:
So if we were hypothetically to agree with what you've said thus far about the CIPs and divisionals, do we reach the issue of consonants?

[00:29:33] Speaker 02:
We do not have to reach the issue of consonants.

[00:29:35] Speaker 02:
In order for Janssen to get out of the safe harbor, they would have to show both that the application they filed was a divisional and the divisional CIP argument works in their favor and that there was consonants.

[00:29:48] Speaker 02:
So if you find with the office on the divisional,

[00:29:52] Speaker 01:
There's an argument that an application changes from a CIP to division, that argument.

[00:30:01] Speaker 01:
Doesn't that blind the face of an argument that consonance is maintained?

[00:30:11] Speaker 02:
So I guess what they're saying is because they got rid of all their additional subject matter, that they were able to still show consonance with the original application where the restriction requirement was made.

[00:30:24] Speaker 02:
And what the office said, and the board does say this at age 25 I think,

[00:30:31] Speaker 02:
So if you look at the 195 application, those claims aren't limited to TNF alpha.

[00:30:37] Speaker 02:
And because the restriction requirement was made in the application that was limited to TNF alpha, it's not consonant with the application that was made.

[00:30:53] Speaker 00:
If there's no further questions, thank you.

[00:30:54] Speaker 00:
Thank you.

[00:30:56] Speaker 02:
Oh, and let me just say, because I've been saying that the office had no practice about the CIA.

[00:31:03] Speaker 02:
There was one instance where they re-examined the MarTech re-exam, and that was before the CIRC report.

[00:31:12] Speaker 02:
And it's cited in every inaugural where during re-examination,

[00:31:18] Speaker 02:
The office did allow an application to change from a CIP to a divisional.

[00:31:29] Speaker 02:
And that is the one instance that I'm aware of.

[00:31:31] Speaker 02:
And it was in the re-exam context.

[00:31:33] Speaker 02:
It was before this, so things came out.

[00:31:36] Speaker 02:
It didn't go to the board.

[00:31:38] Speaker 02:
It was just an exam and a re-exam and they made that decision.

[00:31:43] Speaker 00:
OK.

[00:31:43] Speaker 00:
Thank you.

[00:31:46] Speaker 01:
Council, before you sit down, thank you for pointing that out.

[00:31:49] Speaker 01:
I mean, I was aware of that case and that's an example of a citation that may not go in your favor.

[00:31:56] Speaker 01:
I mean, it doesn't matter in this instance, but thank you for bringing out that type of citation.

[00:32:02] Speaker 02:
Yeah, I'm sorry, but I was thinking those were just a classification.

[00:32:05] Speaker 03:
That is, that's the level I expect from the United States and I'm always glad to see it.

[00:32:16] Speaker 04:
There were a lot of questions that were raised, and I'll try and address all of them as efficiently as I can.

[00:32:22] Speaker 04:
What we heard was that by filing a CIP, Janssen chose to forego the safe harbor protection.

[00:32:31] Speaker 04:
But I also heard a concession that applicants are allowed to change applications, both their designation from a CIP or a continuation

[00:32:44] Speaker 04:
a divisional during the original examination.

[00:32:48] Speaker 04:
Applicants are allowed to amend a specification by deleting added subject matter.

[00:32:55] Speaker 04:
Applicants are allowed to amend claims.

[00:32:58] Speaker 04:
Applicants are allowed to do all these things, and there is no statute or regulation that says that they cannot.

[00:33:06] Speaker 04:
So the basis for

[00:33:08] Speaker 04:
This assertion that by filing a CIP Jansen forever gave up the chance to turn that into a divisional is based solely on their reading of this court's case law.

[00:33:26] Speaker 03:
And perhaps we ought to... And the statute.

[00:33:29] Speaker 04:
Well, there is nothing in Section 121 that requires that to be a divisional on the day it is filed.

[00:33:38] Speaker 04:
In fact, Section 121 incorporates Section 120.

[00:33:43] Speaker 01:
In Section 120... Doesn't 121 require that for the safe harbor to apply that it must be filed as a divisional?

[00:33:51] Speaker 04:
Absolutely not.

[00:33:52] Speaker 04:
What he calls a divisional application in distinction to the preceding application.

[00:33:59] Speaker 04:
It doesn't say this has to be a divisional on the day of filing.

[00:34:04] Speaker 04:
But what it does is it incorporates or refers back to the requirements of Section 120.

[00:34:09] Speaker 04:
Section 120 clearly says that an application can be designated with a priority claim or amended.

[00:34:17] Speaker 04:
To have a priority plan.

[00:34:18] Speaker 03:
On its face, 121 only applies to division.

[00:34:22] Speaker 03:
I'm sorry?

[00:34:23] Speaker 03:
On its face.

[00:34:24] Speaker 03:
section 121 only applies to division.

[00:34:27] Speaker 04:
That's correct.

[00:34:28] Speaker 04:
That's correct.

[00:34:29] Speaker 04:
And it's talking about divisional patents or what are protected there.

[00:34:35] Speaker 04:
And so what it's doing is it's incorporating that section 120 standard and the Pat offices practice under section 120 has been to allow applicants

[00:34:49] Speaker 04:
to change the designation, the claims, and the written description, so that by the time the patent issues, it is a divisional, it's based on a divisional application, and it's called a divisional patent.

[00:35:04] Speaker 04:
The court, I see my time is up.

[00:35:07] Speaker 00:
You can make one more point.

[00:35:08] Speaker 04:
Make one more point.

[00:35:10] Speaker 04:
Yes.

[00:35:10] Speaker 04:
That was it.

[00:35:12] Speaker 04:
OK.

[00:35:13] Speaker 04:
The petition to grant.

[00:35:16] Speaker 04:
The order granting the petition to enter the amendment shows that the 471 patent claims were supported by the 413 parent alone at that time.

[00:35:34] Speaker 04:
And the issued claims of that patent were supported by the parent alone.

[00:35:39] Speaker 04:
That is the hallmark of a divisional as opposed to a CIP.

[00:35:45] Speaker 04:
And that's what it was during prosecution, and that's what it became.

[00:35:50] Speaker 04:
So in conclusion, then, we would ask, because there is no divisional as filed requirement, because the changes apply to the statutes and the regulations, and the claims are consonant, those claims should be entitled to the safe harbor protection, and the board's decision should be reversed.

[00:36:08] Speaker 00:
Thank you.

[00:36:09] Speaker 00:
We thank both sides, and the case is submitted.