[00:00:09] Speaker 00:
We have five cases on our calendar this morning.

[00:00:13] Speaker 00:
Three patent cases, one from the PTAB, two from district courts, trademark case, and a case from the Court of Federal Claims that is being submitted on the briefs and will not be argued.

[00:00:29] Speaker 00:
Our first case is Apotex et al.

[00:00:33] Speaker 00:
versus Novartis.

[00:00:37] Speaker 00:
18-22-09 and others.

[00:00:42] Speaker 00:
Ms.

[00:00:42] Speaker 00:
Ray.

[00:00:46] Speaker 01:
Thank you, Your Honors.

[00:00:47] Speaker 01:
It's a pleasure to be before you this morning.

[00:00:50] Speaker 01:
This is a rather simple, straightforward case.

[00:00:52] Speaker 01:
At the very beginning, I'd like to emphasize that when I speak about Fingolamid throughout this argument, I'm referring to the 0.5 milligram dose, because that's the dose that's of greatest commercial interest for this drug.

[00:01:04] Speaker 01:
OK, this is a simple, straightforward case.

[00:01:06] Speaker 01:
In the orange book is currently listed two patents.

[00:01:09] Speaker 01:
One is the 229 patent.

[00:01:11] Speaker 01:
It just expired in August.

[00:01:13] Speaker 01:
It was the active pharmaceutical ingredient.

[00:01:15] Speaker 01:
It got a full sum 17 years after Issue Life with five years of new chemical entity exclusivity.

[00:01:23] Speaker 01:
So today what we have is the 405 is the sole remaining patent in the Orange Book.

[00:01:28] Speaker 01:
It expires in 2027, and there are six total claims.

[00:01:32] Speaker 01:
And that's the only thing standing between allowing generic Fingola Bid to get on the market.

[00:01:38] Speaker 01:
Now we've removed the 103.

[00:01:39] Speaker 01:
Those are jury arguments.

[00:01:42] Speaker 00:
We're really talking about claims, right?

[00:01:44] Speaker 01:
I am.

[00:01:45] Speaker 01:
I am.

[00:01:45] Speaker 01:
And entitlement.

[00:01:46] Speaker 01:
Correct.

[00:01:47] Speaker 01:
Correct.

[00:01:47] Speaker 01:
I am indeed, Your Honor.

[00:01:49] Speaker 01:
All right.

[00:01:49] Speaker 01:
I'm focusing just on the claims of the 405 patent.

[00:01:52] Speaker 01:
So there's one anticipation issue before the court.

[00:01:55] Speaker 01:
We removed the obviousness rejections to make this as clear and as simple as possible.

[00:02:01] Speaker 01:
So there's three independent claims.

[00:02:03] Speaker 01:
And all three of those independent claims have this negative limitation.

[00:02:08] Speaker 01:
And what the argument is today is should the 405 patent be, or the 504 patent, be awarded the benefit of its earliest British priority date, which is in 2006.

[00:02:22] Speaker 01:
There's an intervening piece of prior art, CAPOS 2010.

[00:02:26] Speaker 04:
And right now, our position is because that negative... Haven't we held before that in the context of PTAD proceedings, assessing whether a patent's entitled to a priority date is not a decision on written description.

[00:02:39] Speaker 04:
It's a deciding priority date, which is necessary in order to resolve whether the prior art asserted is correctly prior art.

[00:02:48] Speaker 04:
So the British... Haven't we held that before?

[00:02:51] Speaker 04:
I'm not asking you about your facts.

[00:02:54] Speaker 04:
I'm saying haven't we held before that it's fair game within the PTAB to have them look at whether there is written description support when somebody is claiming priority to an earlier filing date.

[00:03:07] Speaker 01:
Absolutely.

[00:03:08] Speaker 04:
So that's not a question of written description.

[00:03:11] Speaker 04:
It's a question of priority entitlement.

[00:03:13] Speaker 04:
That's correct.

[00:03:15] Speaker 04:
I can't see any reason why that should matter just because this is a continuation as opposed to a CIP.

[00:03:22] Speaker 01:
That's correct.

[00:03:23] Speaker 01:
It shouldn't make any difference because you don't always call a CIP a CIP and that's totally correct.

[00:03:29] Speaker 01:
But what was done here essentially was a CIP and new information was added to the patent specification.

[00:03:35] Speaker 04:
So very quickly with this issue, what Novartis has tried to do is... You're not basing your argument on new information, right?

[00:03:43] Speaker 04:
You're basing your argument on the fact that at no point in time was this negative limitation disclosed.

[00:03:49] Speaker 01:
That's correct.

[00:03:50] Speaker 01:
Well, until it was introduced into the claims in the amendment in this particular patent that was filed in 2014.

[00:03:58] Speaker 01:
So it could be considered a CIP, I guess.

[00:04:01] Speaker 01:
And so you give it the benefit of that negative limitation could get the benefit of the 2014 date.

[00:04:06] Speaker 01:
That's correct.

[00:04:08] Speaker 00:
But your argument is that it doesn't appear in the 2006 application.

[00:04:16] Speaker 00:
And therefore, they don't get entitled to the 2006 application date.

[00:04:23] Speaker 01:
In very short terms, I totally agree with that.

[00:04:25] Speaker 01:
And therefore, that cap host anticipates?

[00:04:29] Speaker 01:
That's correct.

[00:04:30] Speaker 01:
And there's nothing in the specification that alludes to, suggests, mentions remotely loading doses never mentioned in this patent.

[00:04:39] Speaker 01:
What about the testimony?

[00:04:41] Speaker 00:
The expert who said that's fairly clear from the 2006 application.

[00:04:47] Speaker 01:
So Novartis does try to remedy that.

[00:04:50] Speaker 01:
They try to look at the patent specification.

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They have two experts that have provided testimony.

[00:04:56] Speaker 01:
But frankly, you could have as many experts as you want that say what a POSA would glean from the specification.

[00:05:03] Speaker 01:
But the bottom line is there's nothing in the patent specification for them to address.

[00:05:08] Speaker 01:
There's no hook for them there.

[00:05:11] Speaker 00:
Is it your point that that's a question of patent law, entitlement to an earlier date, rather than something suitable for expert testimony?

[00:05:19] Speaker 01:
That's correct.

[00:05:21] Speaker 01:
I don't think expert testimony was effective in this case, because there wasn't language in the patent specification for them to assist us understanding how a poser would have read it.

[00:05:36] Speaker 01:
All right, so CAPOS, we assume, is

[00:05:39] Speaker 01:
We have the position that CAPOS 2010 is indeed intervening prior.

[00:05:44] Speaker 00:
You say you have a position, but the board said Patent Owner does not dispute that CAPOS discloses each element of the claims.

[00:05:56] Speaker 01:
They never tried to distinguish CAPOS 2010 throughout any of their documents, Your Honor.

[00:06:01] Speaker 00:
Well, we'll hear what they have to say.

[00:06:03] Speaker 01:
We'll hear what they have to say.

[00:06:06] Speaker 01:
So then what Novartis did is they filed a contingent motion to amend before the PTAB.

[00:06:12] Speaker 01:
It wasn't fully considered.

[00:06:13] Speaker 01:
It was considered to be moot.

[00:06:14] Speaker 04:
And what they did is at the very bottom of the- I'm struggling to understand how the amendment is any different.

[00:06:22] Speaker 04:
I'm probably- this is what you would call a friendly question.

[00:06:25] Speaker 04:
I'm struggling to understand how the amendment is any different.

[00:06:29] Speaker 04:
than the claim.

[00:06:30] Speaker 04:
In fact, if anything, it's even broader than the claim that's under consideration.

[00:06:36] Speaker 04:
So I don't know that you have to spend much time on that.

[00:06:41] Speaker 01:
To the extent it's not impermissibly broadening, they back right into the very same prior art they were trying to avoid.

[00:06:49] Speaker 01:
So that is indeed our position.

[00:06:52] Speaker 04:
And I mean, I know that the office hasn't actually ruled on the motion to amend.

[00:06:58] Speaker 04:
Is it your view that should we agree with you completely all the way through and believe this is a reversal and a remand?

[00:07:07] Speaker 04:
And I don't mean a vacate and remand, I mean a reversal and a remand.

[00:07:10] Speaker 04:
Do we need to nonetheless have to remand it so that the board can consider the amended claim?

[00:07:17] Speaker 01:
That is indeed my position, Your Honor.

[00:07:19] Speaker 01:
I think this case is so... Really?

[00:07:20] Speaker 04:
Because I would have gone further for you.

[00:07:22] Speaker 04:
I just said you don't have to remand for the amended claim because the amended claim is non-substantially different from the claim they're seeking and thus... So no remand is necessary.

[00:07:33] Speaker 04:
Sorry.

[00:07:34] Speaker 04:
That's what I would have said, but you've argued to the contrary and I'm not going to let you switch positions now.

[00:07:38] Speaker 01:
OK, sorry if I misspoke.

[00:07:41] Speaker 04:
You didn't misspeak.

[00:07:42] Speaker 04:
You said your position clearly.

[00:07:44] Speaker 04:
It was the position I understood you took from your briefing.

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But I probably would have been willing to go further.

[00:07:50] Speaker 01:
So at this point, we say we do not believe there is a reason for a remand because the claim, I do think, is broadening and just walks right back into the same prior art.

[00:08:00] Speaker 01:
We also have a standing issue before us that we don't think you necessarily need to address because the standing issue is only directed to our gentem.

[00:08:08] Speaker 01:
Apotex's standing has not been challenged.

[00:08:11] Speaker 01:
So the standing issue we don't believe has to be addressed.

[00:08:14] Speaker 01:
The threat of imminent harm, if I could just historically look at this case, once the PTAB wrote the final written decision in this case and it published, within a matter of days, Navard has filed over 20 lawsuits.

[00:08:27] Speaker 01:
So the threat of imminent harm to our gentem is very real in this case.

[00:08:32] Speaker 01:
And we believe that all the elements of standing, even as to our gentem, are met should the court want to

[00:08:39] Speaker 01:
address our gentleman standing in this manner.

[00:08:46] Speaker 00:
We can save the rest of your time for rebuttal if you like.

[00:08:50] Speaker 00:
Thank you so much, Your Honors.

[00:08:52] Speaker 00:
Ms.

[00:08:52] Speaker 00:
Love.

[00:09:01] Speaker 03:
May it please the Court.

[00:09:02] Speaker 03:
Pellants say the board failed to apply a heightened written description standard, but Santeros is a case specific ruling.

[00:09:10] Speaker 03:
and Nike and Infi make clear no higher standard is required.

[00:09:15] Speaker 03:
The test for sufficient written description is whether the disclosure of an application reasonably conveys to those skilled in the art that the inventor had possession of the invention as of the filing date.

[00:09:26] Speaker 00:
But this is a claim limitation, and it isn't found in the 2006 application.

[00:09:33] Speaker 00:
It's not a question of heightened or lowered.

[00:09:36] Speaker 00:
It's just not there.

[00:09:37] Speaker 03:
Well, literal support isn't required under the law in the specification.

[00:09:43] Speaker 03:
And Ariad sets out the well-set of law that the test is how a person of skill would perceive the description that's offered by the application itself in view of the state of the art.

[00:09:54] Speaker 03:
And we have undisputed evidence below from two experts on Appalee's side that's actually in harmony with Dr. Geiser, appellant's expert, that the state of the art as well as the application teaches that no loading dose would be the message to the person of skill.

[00:10:16] Speaker 02:
But wouldn't you say that even the negative limitation has to find support in the specification?

[00:10:22] Speaker 03:
Well, Your Honor,

[00:10:24] Speaker 03:
I believe that it needs to find support in the specification as perceived by the person of skill.

[00:10:30] Speaker 03:
And here, there are, you know, my colleague talked about there being no hook in the specification.

[00:10:37] Speaker 03:
That's not in the briefing, but was just argued.

[00:10:40] Speaker 03:
And I disagree.

[00:10:41] Speaker 03:
There are many hooks in the specification, for example.

[00:10:44] Speaker 03:
The word daily, daily dosing regimen, is one of the key aspects of the invention here.

[00:10:50] Speaker 03:
And a person of skill in this art would immediately recognize that that would exclude a loading dose.

[00:10:56] Speaker 03:
There's specific evidence even using the word exclude from Dr. Steinman on that exact point as well as Dr. Jesko.

[00:11:03] Speaker 03:
So that's one hook.

[00:11:05] Speaker 03:
Another hook is the indication here, RRMS, multiple sclerosis.

[00:11:09] Speaker 03:
That's not the only indication in the art that Fingolimod was used for.

[00:11:13] Speaker 03:
Fingolimod was used in transplant, and indeed with a loading dose.

[00:11:17] Speaker 03:
And that would be well known to the person of skill in this art.

[00:11:20] Speaker 02:
And the message from this application would be... In the case of centauris, we say that negative claim limitations are adequately supported when the specification describes a reason to exclude.

[00:11:31] Speaker 02:
Is there a reason to exclude here?

[00:11:32] Speaker 03:
Yes, Your Honor.

[00:11:33] Speaker 02:
In the specification?

[00:11:36] Speaker 03:
Yes, Your Honor.

[00:11:36] Speaker 03:
The daily dosing description will and has told a person of skill that there should be no loading dose, that a loading dose is to be excluded.

[00:11:47] Speaker 02:
Does it give a reason for that exclusion?

[00:11:49] Speaker 03:
A reason would be known to a person of skill in the art because of the adverse effect, bradycardia, which is a slowing of the heart rate.

[00:11:57] Speaker 03:
It's known to people of skill that Fingolimud causes that adverse effect.

[00:12:02] Speaker 03:
Just as in Santerus, there were adverse effects from that compound.

[00:12:07] Speaker 03:
It would be known to a person, and there's testimony undisputed, way beyond substantial evidence below, that that would be known.

[00:12:20] Speaker 03:
Santeros is a case that's decided on its own facts, and it does not set out a higher standard.

[00:12:28] Speaker 03:
Nike and Infi explicitly say so.

[00:12:31] Speaker 03:
Written description is determined in a case-by-case, application-by-application way.

[00:12:36] Speaker 03:
And negative limitations are no different.

[00:12:39] Speaker 03:
Santeros merely identifies one way negative limitations can be supported and appellants briefs quote pieces of Santeros and the sentence your honor just quoted but link those pieces together with imperative language like must and require but no such commandments are evident in Santeros and Nike and Infi echo that that that

[00:13:01] Speaker 03:
requirement isn't a requirement that the well-settled law in area of written description is what the standard is.

[00:13:10] Speaker 03:
As I mentioned the evidence below from Dr. Steinman and Jesco is unrebutted and Dr. Geiser's testimony is in harmony.

[00:13:21] Speaker 03:
Even if the law required a reason to exclude, which we believe it does not, the board actually did analyze this question below.

[00:13:29] Speaker 03:
Indeed, the word exclude is used by Dr. Steinman several times.

[00:13:34] Speaker 03:
For example, at A 3269.

[00:13:35] Speaker 02:
So is it your argument that the reason to exclude can be inherent in the specification?

[00:13:42] Speaker 03:
No, Your Honor.

[00:13:43] Speaker 03:
Our position is that the reason to exclude

[00:13:47] Speaker 03:
is assessed by looking at how a person of skill perceives the application disclosure.

[00:13:54] Speaker 03:
And it could be inherent.

[00:13:57] Speaker 02:
Doesn't that leave a person of skill in the art guessing and just searching for the needle in the haystack?

[00:14:05] Speaker 03:
No, Your Honor.

[00:14:05] Speaker 03:
It would mean that the person of skill in the art reads the specification and would immediately understand the message.

[00:14:12] Speaker 03:
And here,

[00:14:13] Speaker 03:
that the experts undisputably read the specification and immediately know it's a daily dose.

[00:14:19] Speaker 03:
We know it's Fingolimud.

[00:14:21] Speaker 03:
We know about bradycardia.

[00:14:22] Speaker 03:
No loading dose here.

[00:14:24] Speaker 03:
It's an immediate understanding, just as one would read the words on the page.

[00:14:28] Speaker 03:
But because of their background, they have the benefit of the backdrop of the state of the art in their mind.

[00:14:35] Speaker 03:
And they read it, and it's their perception that is the test.

[00:14:44] Speaker 00:
The reason to exclude may have been pertinent to the cases in which it was talked about, but that's obviously not a criterion for whether there is written description or support to gain entitlement in an early date.

[00:15:04] Speaker 03:
Yes, Your Honor, exactly.

[00:15:05] Speaker 03:
In Santeros, the parties actually

[00:15:09] Speaker 03:
framed up their argument in terms of a reason to exclude.

[00:15:15] Speaker 03:
And the court below made a decision based on a reason to exclude.

[00:15:19] Speaker 03:
And therefore, the Federal Circuit addressed that direct question.

[00:15:23] Speaker 03:
And that is why the Santeros case is written in terms of a reason to exclude.

[00:15:27] Speaker 03:
It's a case-specific issue to Santeros.

[00:15:30] Speaker 03:
Nike and Infi recognized that later in time.

[00:15:33] Speaker 04:
and they address that and put it back into the context of a fact-specific case.

[00:15:49] Speaker 04:
that indicated when the word daily dosing is used what that means, but the board cited Dr. Trisco and his testimony that the recitation and the patent of the daily dose would be understood as clear and complete by APOSA and the absence of any preceding loading dose being mentioned would be understood.

[00:16:10] Speaker 04:
You know, I'm, so is it your view that because of all of those

[00:16:20] Speaker 04:
I guess I'm just not following exactly what you're arguing.

[00:16:24] Speaker 04:
Can you explain it?

[00:16:26] Speaker 03:
Sure, Your Honor.

[00:16:27] Speaker 03:
Our argument is that the well-settled test for written description as set out by Ariad is from the perspective of a person of ordinary skill in the art.

[00:16:39] Speaker 03:
And below, we have all three experts, experts from both sides, in harmony, showing that a person of skill would understand for several reasons

[00:16:49] Speaker 03:
Reading the specification that there should be no loading dose that the loading dose should be excluded One reason is there were specific complete dosing regimens provided for in the application It's the heart of the invention the 0.5 milligram dosing regimen and they would take from that that there should be no loading dose They would also know from the art because they're a person of skill that bradycardia was a risk now bradycardia was a risk for transplant patients, but still a loading dose was given and

[00:17:19] Speaker 04:
here in multiple sclerosis.

[00:17:33] Speaker 04:
exclude mentioned in the spec and you're saying no there doesn't have to be that in centaurus they said when there is a reason to exclude mentioned that's good enough but they didn't say there always has to be and i understand your point on that but but the other point is there has to be some hook in the specification there has to be

[00:17:50] Speaker 04:
something in the spec that would lead a skilled arbiter to understand that this excludes a loading dose.

[00:17:58] Speaker 04:
And I don't see any of the experts, Dr. Jusko or Dr. Steinman, pointing to any spec language that does that.

[00:18:08] Speaker 04:
And those are two different points.

[00:18:10] Speaker 04:
You've blended them all together, which is why I'm kind of confused, but I feel like they're different points.

[00:18:15] Speaker 03:
Well, Your Honor, the experts do point to specific aspects of the specification.

[00:18:20] Speaker 03:
The disclosure of daily dosing as the complete regimen for giving the 0.5 dose is in the specification.

[00:18:28] Speaker 03:
There are two examples in the specification.

[00:18:31] Speaker 03:
One is a human example of dosing.

[00:18:33] Speaker 04:
Where do the experts point to the spec, and which portions of the spec in particular do you think they're relying on?

[00:18:40] Speaker 03:
At A3269, Dr. Steinman says, the dosing schedule necessarily excludes a loading dose.

[00:18:46] Speaker 04:
Where is that?

[00:18:47] Speaker 04:
3269, Dr. Steinman's declaration.

[00:18:51] Speaker 04:
What paragraph?

[00:18:53] Speaker 04:
I have Dr. Steinman's declaration at 3347, but you must be referring to something else.

[00:18:59] Speaker 04:
Where are you telling me to look?

[00:19:06] Speaker 04:
32, what?

[00:19:09] Speaker 03:
32, 69.

[00:19:10] Speaker 04:
Okay, there we go.

[00:19:13] Speaker 04:
Got it.

[00:19:13] Speaker 04:
Yeah, what paragraph?

[00:19:20] Speaker 03:
183, Your Honor.

[00:19:22] Speaker 04:
Paragraph number 183 does not appear on page 32, 69.

[00:19:25] Speaker 03:
Um, 33, 48.

[00:19:31] Speaker 03:
Apologies.

[00:19:35] Speaker 03:
Okay, paragraph what?

[00:19:39] Speaker 03:
183 and 184.

[00:19:40] Speaker 04:
Okay, this just says, the patent mentions daily dose and nothing in the patent says use a loading dose.

[00:19:56] Speaker 04:
How is, I don't see that that gets you where you need to go.

[00:20:01] Speaker 00:
But what you're talking about is testimony that relates to a medical opinion, rather than a patent law question, whether claim limitation is in a particular application.

[00:20:16] Speaker 00:
That's a different story.

[00:20:18] Speaker 00:
Well, Your Honor, I'm- It may be the best you could have done, but it's different.

[00:20:22] Speaker 03:
Well, Your Honor, I believe that, first of all, the person of skill here is a medical doctor.

[00:20:31] Speaker 03:
And therefore, their understanding of what the specification is telling them is really the evidence, the facts upon which the legal determination will be made.

[00:20:42] Speaker 03:
And here, all three medical doctors are seeing the same facts.

[00:20:46] Speaker 03:
Number one, that a daily dose tells them to exclude a loading dose.

[00:20:51] Speaker 03:
And number two, that bradycardia is known and therefore is a risk, and that also in RRMS.

[00:20:58] Speaker 02:
But what it doesn't say is the reason to exclude.

[00:21:00] Speaker 02:
A proposal may apply that medical planning would lead one to exclude, but don't we require that there be some sort of description?

[00:21:13] Speaker 02:
In the case of Enfee that followed the other case, and Terrace that we're talking about, in that case we said,

[00:21:22] Speaker 02:
that whether a specification of the challenge pan provides a person to exclude is sufficient to satisfy the description.

[00:21:30] Speaker 02:
So it's talking about describing the reason to exclude.

[00:21:34] Speaker 02:
And it doesn't describe me something other than the absence or something that's inherent

[00:21:43] Speaker 03:
Well, I think that the law is clear that there does not need to be literal, in hot-verbal, support for a limitation in a claim.

[00:21:56] Speaker 03:
And I also believe that here, Nike and Infi both make clear that the standard is the Ariad standard.

[00:22:06] Speaker 03:
And the Ariad standard takes into account the person of skills perspective.

[00:22:11] Speaker 03:
In this case, there's no dispute about the person of skills perspective.

[00:22:15] Speaker 04:
It is that- The dispute is, there's no dispute that these people understand daily dose to mean a daily dose.

[00:22:24] Speaker 04:
not necessarily to include a loading dose.

[00:22:28] Speaker 04:
In fact, at the end of 184, which you pointed me to, his conclusion is a person of skill would read neither to call for a loading dose.

[00:22:38] Speaker 04:
But there's a difference between whether the word daily dose implies the existence of a loading dose

[00:22:45] Speaker 04:
And whether daily dose excludes the possibility of a loading dose in addition.

[00:22:51] Speaker 04:
And that's a really big difference.

[00:22:54] Speaker 03:
Well, there is a difference.

[00:22:58] Speaker 03:
And a daily dose to the person of skill means that you're giving 0.5 daily each day.

[00:23:04] Speaker 04:
But it doesn't mean you're not giving anything else.

[00:23:06] Speaker 04:
I think in this claim- That's what the testimony doesn't seem to say to me.

[00:23:10] Speaker 04:
What the testimony says is, when they say daily dose, this is how I understand it.

[00:23:14] Speaker 04:
But that doesn't mean the person's not taking anything else, it seems.

[00:23:19] Speaker 03:
I believe Dr. Jesco said, a person of skill would know not to add in any other features to the prescribed dosing regimen, which- But he didn't cite the spec at all.

[00:23:31] Speaker 03:
Well, I believe in his declaration this is all about how he would be reading the specification.

[00:23:36] Speaker 04:
Your time is almost up.

[00:23:37] Speaker 04:
Do you mind if I move you from this to some of the questions I was asking opposing counsel about if we were to disagree with this assessment of priority, what should happen in this case?

[00:23:52] Speaker 03:
Well, the appellants, if they are held to their papers, the panel should affirm the board.

[00:24:06] Speaker 04:
I don't understand that.

[00:24:07] Speaker 04:
If we determine that there is, in fact, no priority and thus this reference should be considered for anticipation, what happens?

[00:24:17] Speaker 03:
Well, if the panel is of that view, then there should be a remand.

[00:24:23] Speaker 03:
We have a motion to amend that should be addressed below by the board.

[00:24:28] Speaker 00:
But you didn't question whether CAPOS is in anticipation.

[00:24:34] Speaker 00:
You seem to have conceded it earlier.

[00:24:37] Speaker 00:
The board said you did.

[00:24:38] Speaker 00:
Do you disagree with that?

[00:24:41] Speaker 03:
I believe that the claims in the motion to amend were not something that was assessed by the board.

[00:24:48] Speaker 04:
But answer Judge Laurie's question directly, not with regard to the amended claims.

[00:24:53] Speaker 04:
The board found in two places, both the institution decision and the final decision, that you did not dispute that CAPOS 2010 did, in fact, anticipate your claims if it was a reference that could be used.

[00:25:05] Speaker 04:
and you didn't respond to any of those comments.

[00:25:07] Speaker 03:
CAPOS 2010 is the publication of the full clinical trial.

[00:25:11] Speaker 03:
There's pretty much no question in it.

[00:25:14] Speaker 03:
So we would need to focus on other aspects.

[00:25:17] Speaker 04:
So what you think because you amended, but I guess my problem is

[00:25:21] Speaker 04:
that your amended claim is not substantially different from the exact same argument you're making on appeal.

[00:25:28] Speaker 04:
All you did was take out the negative limitation, but add in consisting of, which actually narrows the claim even further.

[00:25:36] Speaker 04:
It narrows the claim in exactly this way, the same way, which isn't supported.

[00:25:41] Speaker 04:
So if I conclude you don't have support for narrowing your claim to eliminate the possibility of a loading dose,

[00:25:47] Speaker 04:
and you eliminate not just the possibility of a loading dose, but the possibility of a loading dose or anything else, you still won't have support for it.

[00:25:55] Speaker 03:
Well, Your Honor, we are limiting the claim even more.

[00:25:57] Speaker 03:
So the idea of an up-titration is also excluded in the amended claim.

[00:26:03] Speaker 04:
Yes, but if you don't have support for one of the things you're trying to exclude, it doesn't matter that you're limiting it even more, right?

[00:26:10] Speaker 03:
Yeah, but our view is that we do have support and the recitation of daily and.

[00:26:18] Speaker 04:
But yes, but I'm saying if we don't agree with you on that, if we don't agree with you on that, it's hard for me to understand how there's any daylight between that and your amended claim, what there would be for the board to

[00:26:30] Speaker 04:
need to think about on remand?

[00:26:32] Speaker 03:
The claim would be even narrower and the board would need to make a new assessment on this narrow, narrowed claim.

[00:26:40] Speaker 03:
I understand that if the premise here, which we don't agree with, is that the claim as written would be not supported, the board would need to make a new determination based on an even narrower claim.

[00:26:51] Speaker 00:
Thank you, Ms.

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

[00:26:52] Speaker 00:
Your time has been exceeded and we have your position.

[00:26:57] Speaker 03:
Thank you, Your Honors.

[00:27:10] Speaker 01:
Thank you, Your Honors.

[00:27:11] Speaker 01:
As I indicated, this is a simple case.

[00:27:15] Speaker 01:
And I don't agree with or acquiesce with much of what was just said before.

[00:27:20] Speaker 01:
But I don't see any reason to go through it in detail.

[00:27:23] Speaker 01:
But essentially, Santorus and INFI are the law.

[00:27:26] Speaker 01:
They set the standard.

[00:27:28] Speaker 00:
Well, they don't set the law as to whether a limitation is met in a prior application or not.

[00:27:37] Speaker 00:
They just dealt with the circumstances of those cases.

[00:27:41] Speaker 01:
That's correct.

[00:27:42] Speaker 01:
And our position is that the board erred, though, in not properly applying Santaris and INVI and applying the standards set forth therein.

[00:27:51] Speaker 01:
And also, we do not believe that a remand is necessary.

[00:27:55] Speaker 04:
Well, why for the amended claim?

[00:27:57] Speaker 04:
I don't know what to do about that amended claim.

[00:28:01] Speaker 04:
So the amended claim... That's the words consisting of, which substantially narrows the claim to eliminate more than just the loading dose.

[00:28:10] Speaker 04:
And in our brief, adding the words consisting of narrow the claim more than just by eliminating the no loading dose.

[00:28:24] Speaker 04:
Consisting of means this and nothing but this, right?

[00:28:26] Speaker 01:
That's correct.

[00:28:27] Speaker 01:
But that only relates to the very last clause of that daily dosing regimen of the claim.

[00:28:33] Speaker 01:
you still had the comprising language much earlier in the claim, the linking language that left a lot open.

[00:28:39] Speaker 01:
And in our brief, our corrected final brief, we did put a hypothetical claim seven there where we put in two different dosage regimens.

[00:28:49] Speaker 01:
We hypothetically added another one because the comprising linking language affords the opportunity of even more steps in the process or in the method of treatment.

[00:29:00] Speaker 04:
The comprising was there before.

[00:29:02] Speaker 01:
That's correct.

[00:29:03] Speaker 04:
So I don't understand how you think that broadens the amended claim.

[00:29:07] Speaker 04:
The word comprising was there last time and it's there now.

[00:29:09] Speaker 04:
Right.

[00:29:11] Speaker 01:
So it's always been very open because the comprising language, there can always be additional steps in the method of treatment claims.

[00:29:17] Speaker 01:
And that comprising language was not changed.

[00:29:20] Speaker 01:
It didn't become consisting of

[00:29:22] Speaker 01:
consisting of only related to the very end of the claim, the very bottom part that related to the daily dose of 0.5 milligram.

[00:29:30] Speaker 01:
It wasn't the main linking phrase that was converted from comprising to consisting of.

[00:29:34] Speaker 00:
In which claim does consisting of appear?

[00:29:42] Speaker 01:
In the contingent motion to amend.

[00:29:45] Speaker 01:
It's in claims 1, 3, and 5, I believe.

[00:29:49] Speaker 04:
Tell me where that is in the spec or in the appendix.

[00:30:07] Speaker 04:
Okay, it's on page 910.

[00:30:09] Speaker 04:
I'll help you.

[00:30:10] Speaker 04:
Page 910 is the amended claim, proposed substitute claim seven to replace original claim one.

[00:30:20] Speaker 04:
So.

[00:30:27] Speaker 00:
And what was the contingency?

[00:30:31] Speaker 01:
The contingency was to remove the negative limitation and to introduce the word consisting of.

[00:30:37] Speaker 01:
There never was a comprising in the claim.

[00:30:42] Speaker 04:
Well, there was a comprising in the claim.

[00:30:44] Speaker 04:
That's not correct.

[00:30:44] Speaker 04:
There always has been a comprising in the claim.

[00:30:47] Speaker 01:
The comprising was the original linking phrase at the very top.

[00:30:50] Speaker 04:
And it's still there?

[00:30:51] Speaker 01:
And it's still there, correct.

[00:30:53] Speaker 04:
But how does, when you change this to consisting of, the dosing regimen consisting of, their argument is that this narrows the claim more than just eliminating a loading dose.

[00:31:09] Speaker 04:
It eliminates other things.

[00:31:12] Speaker 01:
but it still has the comprising at earlier, the earlier step in the method of treatment claim, and that open-ended comprising language still gives the opportunity to introduce a loading dose before administering the daily dose.

[00:31:30] Speaker 00:
Anything further, Ms.

[00:31:31] Speaker 00:
Ray?

[00:31:32] Speaker 00:
I'm sorry?

[00:31:32] Speaker 00:
Anything further?

[00:31:33] Speaker 00:
No.

[00:31:34] Speaker 00:
No, Your Honor.

[00:31:35] Speaker 00:
Thank you so much.

[00:31:37] Speaker 00:
We will take the case under advisement.

[00:31:38] Speaker 00:
Thank you.