[00:00:05] Speaker 04:
Okay.

[00:00:07] Speaker 04:
The first argued case this morning is number 18-2232, Kaken Pharmaceutical Company against Ayanuku.

[00:00:15] Speaker 04:
Mr. Livingston.

[00:00:28] Speaker 00:
Good morning, Your Honors, and may it please the Court.

[00:00:31] Speaker 00:
The critical issue before the court is the board's erroneous construction of the claim term onycomycosis to include infections of just skin and visible mucosa.

[00:00:44] Speaker 00:
That construction was pervasive throughout the final written decision and is wrong for at least three reasons.

[00:00:50] Speaker 00:
First, it's at direct odds with the specification.

[00:00:53] Speaker 00:
Second, it's at direct odds with the prosecution history.

[00:00:56] Speaker 00:
And third, it is contradicted by the petitioner's own expert admissions.

[00:01:03] Speaker 00:
Let me begin in the specification.

[00:01:05] Speaker 00:
The term onychomycosis is stated in the, or described in the specification as an infection of the nail.

[00:01:12] Speaker 00:
And in term, the term nail is defined as the nail plate, the nail bed, the nail matrix, and further, these other things that surround it.

[00:01:23] Speaker 02:
Can I ask you a question?

[00:01:24] Speaker 02:
Is the nail bed considered skin?

[00:01:30] Speaker 00:
I believe the nail bed would be considered a skin type organism.

[00:01:35] Speaker 02:
But there's nothing either in the patent or the record of this case that answers that question one way or the other?

[00:01:43] Speaker 00:
I don't believe so, Your Honor.

[00:01:45] Speaker 00:
So the specification doesn't say that onychomycosis is an infection of every single part of the nail, and it doesn't say that onychomycosis is an infection of any single part of the nail in isolation.

[00:01:57] Speaker 05:
The claim uses the term onychomycosis broadly, right?

[00:02:01] Speaker 05:
It doesn't say some subset of onychomycosis.

[00:02:04] Speaker 00:
It does not.

[00:02:05] Speaker 00:
It does not.

[00:02:06] Speaker 05:
And then you define nail to include all of these things, and so how can you then say,

[00:02:13] Speaker 05:
Well, it's an infection of only a portion of the nail.

[00:02:16] Speaker 00:
Well, because the nail is not, you can't conflate the terms nail on onychomycosis.

[00:02:20] Speaker 00:
And the nail, while it is a structure that has many different elements, throughout the specification, throughout the prosecution history, and as understood by those of ordinary skill in the art, onychomycosis must include more than just an infection of a piece of skin.

[00:02:33] Speaker 00:
It must include infections of the nail plate and nail bed.

[00:02:36] Speaker 00:
And that's pervasive throughout the prior art.

[00:02:38] Speaker 05:
Yeah.

[00:02:39] Speaker 05:
The part is the part that, I mean, clearly you have to penetrate the nail, right?

[00:02:47] Speaker 05:
With whatever topical treatment you're using, but.

[00:02:51] Speaker 05:
Couldn't that penetration then be for purposes of treating some other portion of the nail?

[00:02:56] Speaker 00:
Well, I think there's a couple different things here.

[00:03:00] Speaker 00:
Some onychomycosis exists in the nail plate.

[00:03:02] Speaker 00:
So you need to permeate the nail plate just to identify and treat the infection there.

[00:03:06] Speaker 00:
But the more tougher parts of onychomycosis or types of onychomycosis also exist in the nail bed.

[00:03:11] Speaker 00:
And to get there, you have to penetrate through the nail plate to eradicate the infection at the site of disease, which is really the conversation we had with the patent office during prosecution.

[00:03:20] Speaker 05:
Well, I saw that portion that you're citing as the prosecution history that you say is important.

[00:03:26] Speaker 05:
But the only thing that I gleaned from that is that you explained to the examiner and the examiner accepted the proposition that you have to actually go through the nail.

[00:03:40] Speaker 05:
You have to actually be able to penetrate the nail.

[00:03:43] Speaker 05:
But there's nothing in that discussion that says that the only reason you're penetrating the nail is to get to the nail bed.

[00:03:51] Speaker 00:
Well, it's not just to get to the nail bed.

[00:03:52] Speaker 00:
It's also to treat the infection in the nail plate where it sometimes resides.

[00:03:56] Speaker 00:
And a part of that discussion is looking at prior art where there were topical formulations for treating mycosis generally, which is just skin disease, athlete's foot, ringworm.

[00:04:05] Speaker 00:
And the examiner admits this treatment for onychomycosis is different because it permeates the nail bed.

[00:04:11] Speaker 00:
It gets to the nail plate and it can eradicate the infection.

[00:04:14] Speaker 00:
And why would permeation be

[00:04:16] Speaker 00:
important if it was just simply related to a skin structure on the side of the nail.

[00:04:21] Speaker 00:
Permeation would make no difference.

[00:04:23] Speaker 00:
And if you look at the specification throughout, there's a differentiation between skin and nail.

[00:04:28] Speaker 02:
Start though with a portion of the specification.

[00:04:31] Speaker 02:
If we're trying to figure out what anechomycosis is, we start with

[00:04:36] Speaker 02:
column nine, where it says it means something, it means a kind of the above mentioned superficial mycosis.

[00:04:43] Speaker 02:
And then if you go to column five, line 20, mycosis means

[00:04:49] Speaker 02:
a disease which is caused by the invading and proliferating in the tissue of humans or animals.

[00:04:55] Speaker 02:
Usually, mycosis is broadly divided into superficial mycosis, so that's the one that we just said onychomyosis is a subset of, where the seat of the disease lies in the skin or visible mucosa.

[00:05:16] Speaker 02:
What do you do with that?

[00:05:18] Speaker 00:
Well, I think there's a couple pieces there.

[00:05:20] Speaker 00:
First, you rightly note that superficial micosa is an umbrella term that includes, within it, onychomycosis.

[00:05:27] Speaker 00:
The board found differently.

[00:05:28] Speaker 00:
The board found that onychomycosis was the umbrella term that include all superficial micosa.

[00:05:33] Speaker 00:
And that's, I think, objectively incorrect.

[00:05:35] Speaker 05:
But did that finding really matter to their ultimate conclusion?

[00:05:38] Speaker 00:
I think it did.

[00:05:38] Speaker 00:
The final written decision probably mentions 10 times that it dismisses art of record, arguments of record based expressly on its claim construction.

[00:05:48] Speaker 00:
And that's very clear in the final decision.

[00:05:51] Speaker 02:
At the level of the question, there's onychomyosis.

[00:05:57] Speaker 02:
Can that be a fungal infection only of skin?

[00:06:02] Speaker 00:
No.

[00:06:03] Speaker 00:
Why?

[00:06:06] Speaker 02:
And I'd like you to start with the very sequence of definitions that I just asked you about, which ties into my earlier question about whether the bed is a skin.

[00:06:17] Speaker 02:
Because that would be an answer.

[00:06:18] Speaker 02:
for you.

[00:06:20] Speaker 00:
So onycomycosis is defined as a kind of superficial mycosis that infects the nail.

[00:06:26] Speaker 00:
The nail is defined as a number of different structures.

[00:06:29] Speaker 00:
If one of ordinary skill in the art doesn't look at that and think it must be all of the structures and they don't think that it must be a single structure.

[00:06:36] Speaker 00:
And so where are they left?

[00:06:38] Speaker 02:
So let me just try to be, to my mind is a little bit more precise.

[00:06:44] Speaker 02:
The column nine sentence on onychomyosis says two things.

[00:06:49] Speaker 02:
It means a kind of the above-mentioned superficial mycosis.

[00:06:55] Speaker 02:
So that's one thing.

[00:06:57] Speaker 02:
Then it says, in other words, I'm translating here a little bit, a disease which is caused by invading and proliferating in the nail of human or animal.

[00:07:08] Speaker 02:
That seems to me to direct us, the first clause directs us to the mycosis.

[00:07:13] Speaker 02:
superficial mycosis definition.

[00:07:16] Speaker 02:
The second clause directs us to the nail definition.

[00:07:20] Speaker 02:
Can you tell me something about the first clause before talking about the nail definition?

[00:07:25] Speaker 00:
Only that onycomycosis is a subset of superficial mycosis.

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

[00:07:30] Speaker 00:
Superficial mycosis includes anything on the outside.

[00:07:33] Speaker 02:
Skin.

[00:07:33] Speaker 02:
Well, it says expressly in column 5.

[00:07:35] Speaker 02:
Skin.

[00:07:35] Speaker 02:
Skin or.

[00:07:36] Speaker 00:
Visible mucosa, which would be your mouth or nostrils, right?

[00:07:39] Speaker 00:
Right.

[00:07:39] Speaker 00:
And I think it's clear that onycomycosis does not include infections of your mouth or nostril.

[00:07:44] Speaker 02:
Does it involve.

[00:07:46] Speaker 02:
the nail bed, I'm going to, nail plate or nail bed?

[00:07:50] Speaker 00:
Is a nail plate skin?

[00:07:52] Speaker 00:
If you, a nail plate includes keratin, but it's extremely different from the keratin composition in skin.

[00:07:58] Speaker 00:
It's not, it's not called skin.

[00:08:01] Speaker 00:
Nail bed, I'm not sure the composition of the nail bed is in the record, but nail bed is certainly a seat of infection in an onychomycotic model.

[00:08:09] Speaker 00:
It's why they continually talk about penetrating the nail plate to get to the nail bed, because that's where infection results.

[00:08:16] Speaker 05:
Is that the only portion of the nail that can ever get infected?

[00:08:19] Speaker 00:
Of course not, not.

[00:08:21] Speaker 00:
In very bad cases of onychomycosis, every portion of the nail.

[00:08:25] Speaker 00:
can be infected.

[00:08:25] Speaker 00:
And we're not saying that our claim construction excludes those, but a single portion on the outside of the nail, hyponechium for instance, as the only thing being infected, is a term by doctors called paranechia.

[00:08:39] Speaker 00:
It's an entirely different disease.

[00:08:40] Speaker 05:
Paranechia is a subset of onychomycosis.

[00:08:43] Speaker 00:
No, it's not.

[00:08:44] Speaker 00:
It's a totally different disease.

[00:08:45] Speaker 05:
There's at least expert testimony to that effect, right?

[00:08:47] Speaker 00:
I don't believe so.

[00:08:51] Speaker 00:
All the testimony has been that paranechia is a separate disease state.

[00:08:54] Speaker 00:
When you come in to a physician and you say, I've got, you know, infection around my nail, they say that's a paranechia, they treat that one way.

[00:09:00] Speaker 00:
When you have an infection that includes the nail plate, as described in the prior art and as seen by physicians, that's an onychomycotic infection.

[00:09:08] Speaker 04:
So is it correct?

[00:09:09] Speaker 04:
Is this the aspect of the claim construction that you propose to resolve by reissue, by a narrowing reissue?

[00:09:19] Speaker 00:
That is part of it, yes.

[00:09:20] Speaker 00:
We have proposed claims in the reissue to avoid any of these issues under the claim construction of the board.

[00:09:28] Speaker 00:
Exactly.

[00:09:29] Speaker 04:
And so had that reissue been entered as you requested, would we have this question before us?

[00:09:38] Speaker 00:
I think we would.

[00:09:39] Speaker 00:
I think we would, because we're entitled to the broader scope of our claims.

[00:09:43] Speaker 00:
And while those claims are more narrow, we consider the board's claim construction to include just skin infections as hopelessly broad and not grounded in the specification, the intrinsic evidence, and the other art of record.

[00:09:57] Speaker 00:
And I think when you're looking at the patent and you wonder, how does one of ordinary skill in the art look at the patent?

[00:10:01] Speaker 00:
Because that's really the question, right?

[00:10:03] Speaker 00:
Under the Phillips, you have to look at the patent through one of ordinary skill in the art.

[00:10:07] Speaker 00:
The best evidence is probably the petitioner's own expert.

[00:10:10] Speaker 00:
For this proceeding, looking at the 506 patent with the eyes on, you know, filing an IPR, that expert said the disclosure of superficial mycosis in the patent does not describe treating on-income mycosis.

[00:10:25] Speaker 00:
That expert looked at the comparative examples in the specification that relate to skin treatment and said those don't relate to the treatment of on-income mycosis.

[00:10:34] Speaker 00:
That's at AP1031.

[00:10:35] Speaker 02:
So you said an expert said that anechomyosis is not a kind of superficial mycosis?

[00:10:47] Speaker 00:
I apologize if I said that.

[00:10:47] Speaker 00:
That's not what I meant.

[00:10:49] Speaker 00:
It's clear that onychomycosis is a subset of superficial mycosis, not the other way around.

[00:10:54] Speaker 00:
And that's what the board did.

[00:10:55] Speaker 00:
They construed the claim such that onychomycosis includes superficial mycosis, which would include things like visible mucosa, which is mouth and nostrils, and things that clearly aren't related to the nail.

[00:11:05] Speaker 05:
Didn't your own experts say that onychomycosis generally begins in the skin structures around the nail?

[00:11:13] Speaker 00:
Yes, typically in a patient, they get athlete's foot, they don't treat it, and it can invade and proliferate into the nail bed or through the nail plate and become onychomycosis.

[00:11:24] Speaker 05:
Okay.

[00:11:26] Speaker 05:
So you're saying that it's not actually onychomycosis until it goes through the nail plate.

[00:11:32] Speaker 00:
That's right, and I think that's consistent with both what our expert said and what Dr. Walters said.

[00:11:36] Speaker 00:
He said you can have an infection of the hyponychium that can become onychomycosis, but until it gets into the nail plate or nail bed, it's paronychia.

[00:11:45] Speaker 00:
It's a different disease state.

[00:11:48] Speaker 00:
Another admission by Dr. Walters related to killing destruction is that he looked at

[00:11:53] Speaker 00:
the skin examples in the patent.

[00:11:56] Speaker 00:
And he said, those treatments of skin don't relate to onychomycosis.

[00:12:00] Speaker 00:
And that's one of ordinary skill in the art, looking at the patent objectively in this proceeding and saying skin doesn't relate to nail.

[00:12:06] Speaker 00:
They're just not the same.

[00:12:08] Speaker 00:
And that's why we proposed the construction that's consistent with both the desire to permeate the nail plate to get to the nail bed and eradicate the infection where it resides, which is a penetrating infection of both the nail plate and or nail bed.

[00:12:23] Speaker 05:
Let me that last point that in briefing below, you said now play and now then.

[00:12:31] Speaker 05:
And then.

[00:12:32] Speaker 05:
In our briefing, you have the and or language.

[00:12:35] Speaker 05:
Is that a meaningful difference?

[00:12:37] Speaker 00:
I think it is, because there are instances of onychomycosis.

[00:12:43] Speaker 00:
Almost every single one involves the nail plate.

[00:12:45] Speaker 00:
But there are other more difficult to treat portions that our claim should cover that also involve the nail bed.

[00:12:51] Speaker 00:
And there are instances.

[00:12:52] Speaker 05:
Wasn't your claim construction based on the fact that you needed both?

[00:12:58] Speaker 00:
I don't think you have to have both.

[00:12:59] Speaker 00:
I don't think you have to have both.

[00:13:01] Speaker 00:
There are types of onychomycosis that are just involved in nail plate.

[00:13:05] Speaker 05:
OK.

[00:13:06] Speaker 05:
And then what else do they involve?

[00:13:08] Speaker 05:
Just the plate?

[00:13:09] Speaker 00:
Almost.

[00:13:10] Speaker 00:
So if you look at our expert, Dr. Lusky, in 1999 wrote a review article on onychomycosis.

[00:13:15] Speaker 00:
She's the only expert of record that had done that.

[00:13:17] Speaker 00:
And she defines all types of onychomycosis.

[00:13:19] Speaker 00:
And each definition includes at least a nail plate.

[00:13:23] Speaker 00:
Some include a nail plate and or a nail bed.

[00:13:30] Speaker 00:
So with my remaining time, I'd like to go to the substantial evidence question.

[00:13:36] Speaker 04:
Do you want to save your time for rebuttal or something you need to show us?

[00:13:39] Speaker 00:
I've got two minutes left, Your Honor, if you'll permit me, in my opening.

[00:13:46] Speaker 02:
OK.

[00:13:46] Speaker 00:
Do I not?

[00:13:49] Speaker 02:
Is this clock including the rebuttal time?

[00:13:51] Speaker 00:
It usually does.

[00:13:53] Speaker 00:
OK, then I will save it.

[00:13:57] Speaker 00:
Thank you, Your Honor.

[00:14:05] Speaker 01:
Good morning and may it please the court.

[00:14:19] Speaker 01:
As plainly set forth in the specification, Katkin's claims cover treatment of the skin surrounding the nail with efekonazole.

[00:14:26] Speaker 01:
Efekonazole was known to be effective against skin infections and thus the claims are obvious.

[00:14:32] Speaker 04:
Let me ask you, what claim

[00:14:35] Speaker 04:
Do you want us to review on appeal the narrowed claim that they have been trying to enter into this case through reissue, or what?

[00:14:46] Speaker 01:
No, Your Honor.

[00:14:47] Speaker 01:
I think it has to be the claims that were at issue in the IPR.

[00:14:50] Speaker 01:
So as we said in our 28J, the office has just begun examination of the reissue claim.

[00:14:57] Speaker 04:
Yes, you want an advisory opinion from this court on the broader claim.

[00:15:02] Speaker 04:
after which the office will decide whether to proceed with a narrowed claim, which they're entitled to narrow as of right?

[00:15:12] Speaker 01:
So, Your Honor, I don't think it would be an advisory opinion, because as my colleague on the other side said, they are still seeking these claims.

[00:15:19] Speaker 01:
But would be.

[00:15:20] Speaker 04:
They're entitled to a reissue.

[00:15:22] Speaker 04:
The statute says the director shall reissue.

[00:15:27] Speaker 04:
It's not permissive.

[00:15:28] Speaker 04:
So they're entitled to the reissue.

[00:15:32] Speaker 04:
You have refused to permit them to do that in a timely way.

[00:15:37] Speaker 01:
No, Your Honor.

[00:15:38] Speaker 01:
I mean, they may be entitled to the reissue if their claims are patentable, but that's, of course, what the examination proceeding... I don't see any such if in the statute.

[00:15:47] Speaker 04:
The statute is crystal clear that you pay the fee, you meet the requirements, and the director shall reissue the patent, not if we feel like it, not if some other tribunal

[00:16:01] Speaker 04:
decides it's inconvenient.

[00:16:06] Speaker 01:
To be sure, Your Honor, if the claims are patentable, then they would be entitled to the reissue.

[00:16:12] Speaker 04:
So why are you asking us to decide a claim that they have the right to change?

[00:16:20] Speaker 01:
So, Your Honor, they still believe they're entitled to the claims that are before the court today.

[00:16:26] Speaker 01:
We do not believe they are entitled to those claims.

[00:16:29] Speaker 04:
They had no choice.

[00:16:30] Speaker 04:
go forward with a reissue until, according to what you wrote to us two days ago?

[00:16:36] Speaker 01:
Well, Your Honor, I understand that they would still want these claims even if we were to potentially grant the reissue.

[00:16:44] Speaker 01:
So I don't know that that's necessarily the case, Your Honor.

[00:16:51] Speaker 01:
And we are proceeding with the reissue.

[00:16:53] Speaker 01:
The reason for the delay was simply the office's workload, and it doesn't make sense.

[00:17:01] Speaker 04:
The statute doesn't say that if you're busy, you can refuse to proceed with a reissue.

[00:17:08] Speaker 04:
I can't find that in the statute.

[00:17:09] Speaker 04:
I just looked.

[00:17:10] Speaker 01:
Well, Your Honor, I don't think the office was refusing to proceed with reissue.

[00:17:16] Speaker 01:
fairly well-established principle of administrative law that agencies can sort of decide when they act on particular... They actually put a stay on.

[00:17:24] Speaker 05:
That's different than not getting to it.

[00:17:26] Speaker 01:
Well, they put the stay on it out of concerns for workflow.

[00:17:34] Speaker 01:
So if this court were to decide that they were entitled to the claims at issue today, then that would obviously inform the course of

[00:17:42] Speaker 01:
The reissue and there are other applicants that are the examiners are working on their applications right now and it's a question of are they going to focus on this application which may become moot depending upon what this appeal is or the examination proceedings would go differently depending upon the outcome of this appeal or are they going to work on the applications of

[00:18:01] Speaker 01:
the other applicants before the office.

[00:18:04] Speaker 01:
So I don't think it's a question of us refusing to.

[00:18:07] Speaker 01:
I think it's a question of efficient allocation of resources.

[00:18:09] Speaker 04:
The refusal is crystal clear.

[00:18:11] Speaker 04:
You say we stay.

[00:18:14] Speaker 04:
Did you refund their filing fee for the reissue?

[00:18:18] Speaker 01:
Not to my knowledge, Your Honor, but of course we are proceeding with the examination.

[00:18:22] Speaker 01:
As the Federal Register notice lays out, it's a matter of

[00:18:27] Speaker 01:
efficiency, and then we give applicants the opportunity.

[00:18:30] Speaker 04:
Notice is contrary to the statute.

[00:18:32] Speaker 04:
Statute doesn't say if you feel like it on a three-page notice of contingencies.

[00:18:40] Speaker 04:
It says shall reissue.

[00:18:43] Speaker 01:
Yes, Your Honor, shall, but it's a question.

[00:18:45] Speaker 04:
Shall process the reissue if it complies with the statute.

[00:18:49] Speaker 04:
A narrowing reissue is what I gather they're asking for because of the breadth of the claim construction.

[00:18:57] Speaker 01:
Yes, Your Honor, but of course it's a question of whether or not those claims are in fact narrow or whether or not there's some other problem with patentability.

[00:19:05] Speaker 01:
That's what the... Precisely.

[00:19:06] Speaker 04:
They're entitled to an examination of the reissue.

[00:19:10] Speaker 04:
There are no safeguards of this sort.

[00:19:15] Speaker 04:
There are no contingencies in that statute.

[00:19:18] Speaker 04:
Shall reissue and yet twice you've stated... Yes, Your Honor, but of course it's... Forcing them to proceed with this appeal on

[00:19:26] Speaker 04:
claims, broad claims, that they have been trying to narrow for how long a year.

[00:19:36] Speaker 01:
I believe they filed the reissue application in 2017.

[00:19:41] Speaker 01:
But of course, Your Honor, the fact that they're entitled to a, the fact that they may be entitled to a reissue, a reissue patent doesn't mean that the office is obliged to or even could act immediately upon every application.

[00:19:56] Speaker 05:
Of course, we would- How does the board have authority to state it?

[00:20:00] Speaker 05:
So- I could see where the director might say, you guys are too busy, so we're not going to do this, this, or that.

[00:20:05] Speaker 05:
But the board doesn't have any authority to tell the examiners not to act according to the statute?

[00:20:11] Speaker 01:
Under 315, Your Honor, I believe the board does have the authority to stay when there's a... It's not in the statute?

[00:20:19] Speaker 04:
It says the director shall on the surrender of such patent.

[00:20:22] Speaker 04:
and the payment of the fee required by law, reissue the patent.

[00:20:27] Speaker 04:
It doesn't say if the board feels like it.

[00:20:30] Speaker 02:
No, Your Honor, but three... Were you talking about one of the IPR provisions in 315?

[00:20:34] Speaker 01:
Yes, Your Honor, I'm talking about in 315.

[00:20:36] Speaker 01:
Not in the reissue provision.

[00:20:38] Speaker 04:
It doesn't say if it happens to be under IPR review.

[00:20:46] Speaker 04:
That statute was not amended to provide all that.

[00:20:50] Speaker 01:
I would point your honors to Section 315D, multiple proceedings, which says that notwithstanding various other sections, including, I believe, the reissue proceeding, during the pendency of an inter partes review, if another proceeding or matter involving the patent is before the office, the director may determine the manner in which the inter partes review or other proceeding may proceed, including providing for a stay, transfer, or consolidation.

[00:21:18] Speaker 01:
So that is, and I believe that authority of the director has been delegated to the board, which is why they issued the stay.

[00:21:25] Speaker 01:
And then when it came back to patents for their own workflow reasons, they put on the suspension.

[00:21:32] Speaker 05:
But the IPR is not pending once the final written decision is issued, right?

[00:21:38] Speaker 01:
No, Your Honor, that is their argument.

[00:21:41] Speaker 01:
I don't think that's right because, of course, after a final written decision issues, there could be a pop panel afterwards for the director to review the case.

[00:21:53] Speaker 01:
There could also be an appeal to this court.

[00:21:57] Speaker 01:
But more importantly, I think that issue was moot because, of course, the state, the suspension that they were complaining of in their reply was issued by patents.

[00:22:06] Speaker 01:
which has nothing to do with the pendency of the IPR necessarily.

[00:22:11] Speaker 01:
And then, of course, that has been lifted and the re-examination is going to proceed.

[00:22:16] Speaker 04:
So why was this reissue application stayed twice?

[00:22:20] Speaker 01:
I your honor I believe it was because of the workload of the office as the board was of the view that Look, we're adjudicating these claims If we decide that they these claims are patentable then that could moot the reissue application and obviate the need for further examination and expenditure of those resources and Then when patents got it they felt the same way of course under the federal register notice it does provide applicants a way to

[00:22:50] Speaker 01:
to petition the office to say that, look, our claims are colorably different than the ones that are proposed reissued claims are colorably different than the ones that are at issue in the IPR proceeding.

[00:23:01] Speaker 01:
And so we request that you proceed with the examination.

[00:23:05] Speaker 01:
But they did petition, did they not?

[00:23:07] Speaker 04:
And they were denied.

[00:23:08] Speaker 01:
No.

[00:23:09] Speaker 01:
So they petitioned in September.

[00:23:11] Speaker 01:
And the lifting of the suspension that occurred last week was the decision on that petition.

[00:23:18] Speaker 04:
So it's expeditious processing in the time limits that the entire policy here is that there will be some sort of expediency in the way the office handles applicants.

[00:23:34] Speaker 01:
Yes, Your Honor.

[00:23:35] Speaker 01:
And the stay was originally put on for six months, I think,

[00:23:39] Speaker 01:
precisely so that it would pop up again and the examiner would have to relook at it and of course this happened in less than that time frame.

[00:23:46] Speaker 01:
Admittedly it would be good if we could get to applications even faster than that but this was them acting on the petition.

[00:23:58] Speaker 01:
Provision that relates to re issues it doesn't does it I'm to be honest I said I'm not sure your honor I think it does but I'd have to look up the other provisions that are cited there and it's To be honest with you your honor I am not positive it cites 251 I

[00:24:18] Speaker 01:
which actually is reissued, yes.

[00:24:21] Speaker 01:
So your honor, it says not withstanding sections 251 and then 251 is the section dealing with reissue.

[00:24:31] Speaker 02:
Can I ask you, can we turn to the?

[00:24:34] Speaker 02:
Yes.

[00:24:35] Speaker 02:
Okay.

[00:24:36] Speaker 02:
So your brief in this case seemed to me to make a case for the correctness of the unpatentability ruling

[00:24:48] Speaker 02:
barely dependent on this claim construction, to make an argument that I think downplayed would be an accurate word.

[00:25:02] Speaker 02:
It seems to me that the board relied on its claim construction in a pretty pervasive way and hasn't really made

[00:25:14] Speaker 02:
a determination of unpatentability independent of the claim construction.

[00:25:20] Speaker 02:
And just on that assumption, it seems to me, therefore, the case comes down to the claim construction, which I'm not sure you directly defended in your brief.

[00:25:32] Speaker 02:
What do I make of that?

[00:25:35] Speaker 01:
Well, Your Honor, to be sure, our brief did not include a separate heading for claim construction.

[00:25:40] Speaker 01:
But pages 33 through 35 of our brief

[00:25:45] Speaker 01:
make the claim construction argument.

[00:25:47] Speaker 01:
And I think the claim construction is actually not terribly difficult.

[00:25:52] Speaker 01:
Because I would point the court to where the court was before column nine.

[00:26:03] Speaker 01:
It says that anechomocosis is a kind of mycosis proliferating in the nail.

[00:26:09] Speaker 02:
And so what you just did was to skip the first clause.

[00:26:14] Speaker 02:
Everybody, nobody wants to talk about the first clause.

[00:26:16] Speaker 02:
Why?

[00:26:18] Speaker 01:
Well, I think the first clause is helpful.

[00:26:20] Speaker 01:
I think the second clause is even stronger.

[00:26:23] Speaker 01:
But if your honor would, if it would be helpful, I'm happy to talk about the first clause because the first clause talks, it says it's a type of superficial mycosis.

[00:26:31] Speaker 02:
The reason I guess I'm focused on that is it seems to me it's relatively easy textually.

[00:26:37] Speaker 02:
to take the second clause and say it proliferates in the nail.

[00:26:42] Speaker 02:
That doesn't mean it proliferates in every component that was in the nail.

[00:26:47] Speaker 02:
So that doesn't seem to me to compellingly say it covers even certain kind of fungal things in the skin.

[00:26:56] Speaker 02:
The first one, though, seems to say it is a kind of skin mycosis.

[00:27:03] Speaker 01:
I think it's both, Your Honor.

[00:27:05] Speaker 01:
It does say skin mycosis.

[00:27:08] Speaker 01:
And superficial is skin or mucus, right?

[00:27:11] Speaker 01:
Precisely.

[00:27:12] Speaker 01:
But then I think it's also important to look at the definition of nail.

[00:27:15] Speaker 01:
So if you look at page four, I'm sorry, column four of the patent, appendix 64, it lists, among other things, eponychium and hyponychium.

[00:27:25] Speaker 01:
And on page nine of their brief, they concede

[00:27:29] Speaker 01:
that those are skin structures and their expert made the same concession.

[00:27:34] Speaker 01:
The other thing I would... Let me see if I can convey this.

[00:27:38] Speaker 02:
If I say a disease invades the nail, that language by itself doesn't mean anything more necessarily than it invades some portion of the nail.

[00:27:52] Speaker 02:
And so this may be a plate-only disease.

[00:27:55] Speaker 02:
I'd still say it invades the nail, where it may be a matrix only.

[00:28:01] Speaker 02:
It doesn't mean, that language by itself, that any component that is part of the nail is one that this disease invades.

[00:28:12] Speaker 01:
Well, I think, Your Honor, you need to look at the definition of nail in the specification.

[00:28:18] Speaker 01:
That might be true in ordinary parlance.

[00:28:21] Speaker 01:
If you said, I have an infection in my nail, an ordinary person on the street might think of nail plate.

[00:28:28] Speaker 01:
But here, when the definition in the specification describes particular structures that include, by patent owner's admission, skin structures, and then you have evidence in the record

[00:28:42] Speaker 01:
that it would have been obvious to treat this, to treat a skin infection with the claimed compound, I think that gets you there.

[00:28:51] Speaker 01:
The other thing that I think it's important that I don't want to forget is if you look at appendix 40, which is in the decision, the board references their expert's admission that superficial white onychomocosis would have been easy to treat

[00:29:08] Speaker 01:
with any antifungal compound.

[00:29:11] Speaker 01:
And even if you accept their definition of plate, the superficial white onychomycosis is part of the plate.

[00:29:18] Speaker 05:
What do you do about the fact that the board clearly aired when it said onychomycosis includes superficial

[00:29:27] Speaker 01:
I think it would have been better if the board was clearer.

[00:29:32] Speaker 01:
I think when you read the board's decision in context, that's not what they were saying.

[00:29:38] Speaker 05:
Well, it's clear it's the other way around.

[00:29:40] Speaker 01:
Absolutely, Your Honor.

[00:29:41] Speaker 01:
Onychomycosis is a subset of superficial mycosis.

[00:29:44] Speaker 05:
They said it more than once.

[00:29:46] Speaker 01:
I agree that they did get it backwards more than once, but I think when you read the full context of the opinion, that's not what the board was saying.

[00:29:57] Speaker 05:
Your friend on the other side said that the expert testimony was that while this onychomycosis, the infection can begin

[00:30:06] Speaker 05:
in the skin structure surrounding the nail, but it doesn't really become onychomycosis until it invades the nail plate.

[00:30:12] Speaker 01:
He's relying on extrinsic evidence to reach that conclusion, and I think in light of the definition of nail here, which of course Philip says you have to look at the specification definition first, that that would supersede it, because the definition of nail, onychomycosis is

[00:30:28] Speaker 01:
Mycosis affecting the nail nail here includes strength skin structure.

[00:30:33] Speaker 05:
Well, what about the prosecution history?

[00:30:34] Speaker 01:
That's pretty limiting isn't it was so the prosecution history issue was not raised before the board and Moreover, I would also say that Phillips still says you look to the specification definition first I mean it would I think I remember right your brief did not discuss the prosecution history

[00:30:51] Speaker 01:
I don't believe it did, Your Honor.

[00:30:54] Speaker 02:
I searched for 1589, 1607, 1609 prosecution.

[00:30:57] Speaker 02:
None of those came up.

[00:30:59] Speaker 01:
No, I don't think so.

[00:31:00] Speaker 01:
But again, Your Honor, Philip says you must look to the definition of the specification before you get even to prosecution history, let alone the extrinsic evidence.

[00:31:08] Speaker 02:
But suppose I thought, for textual reasons, that the specification was a bit of a mixed bag.

[00:31:17] Speaker 02:
I would be inclined, I think, to find the prosecution history in this matter extremely strong for Kaken.

[00:31:25] Speaker 02:
Kaken or Kaken?

[00:31:28] Speaker 01:
Kaken.

[00:31:28] Speaker 01:
Of course.

[00:31:31] Speaker 01:
I looked for a pronunciation guide online.

[00:31:33] Speaker 01:
I couldn't find it.

[00:31:34] Speaker 01:
I would say a couple of things about that.

[00:31:39] Speaker 01:
I don't think we're denying that it would be a good thing to be able to penetrate the nail.

[00:31:46] Speaker 02:
But this was the ground for distinguishing, was it the 944, the earlier patent which was asserted in support of an obviousness type double patenting claim.

[00:32:03] Speaker 02:
They came back and said, the difference is that ours actually penetrates the nail.

[00:32:09] Speaker 02:
And then the examiner came back and said, oh, now I allow it.

[00:32:12] Speaker 02:
And he referenced the reasons for allowance.

[00:32:16] Speaker 02:
which, I don't know, three times said, the thing that's persuading me here is we are talking about a claim that involves penetrating of the nail, of the nail plate, sorry.

[00:32:27] Speaker 01:
I think another trouble with that, Your Honor, is that they even admit that superficial white onychomycosis is a type of mycosis, and that that shouldn't require, that doesn't require penetration of the nail.

[00:32:38] Speaker 01:
So even on their own, by their own inclusion of that... Is it a type of onychome?

[00:32:43] Speaker 01:
Yes, superficial white onychomocosis is a type of onychomocosis that does not require penetration of the nail per their expert submission, appendix 40.

[00:32:53] Speaker 02:
Is that because time has not, enough time hasn't passed that it hasn't yet started digging in?

[00:33:01] Speaker 01:
Potentially, Your Honor, I don't think there's anything in the record about

[00:33:04] Speaker 01:
how likely superficial white is to proliferate elsewhere into the nail.

[00:33:09] Speaker 01:
There may be a number of factors.

[00:33:11] Speaker 01:
I don't think that's a question of record, but nevertheless, that is squarely within the definition of onychomocosis.

[00:33:17] Speaker 01:
They concede that on their brief at page 15, note 2.

[00:33:24] Speaker 01:
Given that, you don't need to penetrate the nail because of its superficiality.

[00:33:31] Speaker 01:
So when you take

[00:33:31] Speaker 01:
the broad definition of nail that includes things that they admit are skin structures.

[00:33:37] Speaker 01:
And also at reply six, they're not conceding, they're not appealing the definition of nail.

[00:33:45] Speaker 01:
And then when you also look to the superficial white, I think all of that would outweigh whatever they have in the prosecution history.

[00:33:52] Speaker 04:
So what are we to make of this?

[00:33:53] Speaker 04:
You tell us of their concessions.

[00:33:56] Speaker 04:
You have agreed that there is a clear error.

[00:33:59] Speaker 04:
in the board's decision, which you correct an oral argument in the federal circuit, is remain in silence otherwise.

[00:34:11] Speaker 04:
And this is, it's important that we make sure that this system, this new system under the American Vents Act operates as it's intended.

[00:34:25] Speaker 04:
not as a game between protagonists.

[00:34:30] Speaker 04:
And I'm concerned, as you can see, as to the role of the office and of the board in seeing that this public policy is fulfilled.

[00:34:43] Speaker 01:
Your Honor, I also share your concern with making sure that the statute functions as intended.

[00:34:50] Speaker 01:
I think that's why it's

[00:34:51] Speaker 01:
Also important to focus on the text of the specification because I think it would be quite unfortunate for patent owners if you know extrinsic evidence about what you know doctors may or may not have thought controlled the definition as opposed to what is squarely in the specification because you know as Philip says and as makes sense.

[00:35:11] Speaker 01:
You want a person of skill and the art to be able to read the specification and understand the invention and the scope of the claims.

[00:35:18] Speaker 01:
And if you have to go digging through, when something is as crystal clear as this, and you have to go digging through the prosecution history or even worse, extrinsic evidence to figure it out when there's a plain on-its-face definition that includes skin structures, I think that would be... That's where the reissue comes in.

[00:35:36] Speaker 01:
And yes, Your Honor, and we are proceeding with the reissue.

[00:35:40] Speaker 01:
And as the office's decision said, they have colorable arguments that there may be something patentable there.

[00:35:50] Speaker 01:
And we're going to proceed with the reissue application expeditiously.

[00:35:54] Speaker 01:
And we've lifted the stay and are going to proceed with it.

[00:36:00] Speaker 04:
Thank you.

[00:36:02] Speaker 04:
Okay, will you enlarge Mr. Levinson's time by the amount we've run over?

[00:36:06] Speaker 04:
I think we've come to eight minutes.

[00:36:10] Speaker 00:
Thank you, Your Honor.

[00:36:12] Speaker 00:
It's very generous of you.

[00:36:14] Speaker 04:
Where is your BRI, right?

[00:36:16] Speaker 04:
What that?

[00:36:17] Speaker 04:
You're stuck with BRI.

[00:36:18] Speaker 00:
I am stuck with BRI.

[00:36:19] Speaker 00:
You're right.

[00:36:20] Speaker 04:
And again, it seems to me that that's where reissue comes in.

[00:36:24] Speaker 04:
It's one way of overcoming this

[00:36:28] Speaker 04:
curious imposition of BRI post-grant?

[00:36:32] Speaker 00:
That is one way, Your Honor, but I think that we submit that BRI still must be reasonable, and the claim construction, I think, as just admitted, is unreasonable in light of the specification.

[00:36:42] Speaker 05:
What do you do with the white superficial comycosis that your expert talked about?

[00:36:47] Speaker 00:
It certainly involves the nail plate, and there has been no factual finding on the record under a correct claim construction that you can go from skin to nail in efficacy.

[00:36:57] Speaker 00:
And that's at Appendix 40.

[00:36:59] Speaker 00:
The board even called that a leap.

[00:37:01] Speaker 00:
They said, requiring one of ordinary skill in the art to make such a leap is unnecessary in light of the breadth of the claims.

[00:37:08] Speaker 00:
There has been no factual findings under a correct claim construction on any of those issues.

[00:37:12] Speaker 00:
That was assumed based on an incorrect and broadly broad claim construction.

[00:37:19] Speaker 00:
You discussed a second ago the prosecution history.

[00:37:22] Speaker 00:
I agree it's pretty clear.

[00:37:24] Speaker 00:
But I would submit that if we were arguing today the opposite, what the director is arguing, that is, we're seeking to prove infringement of a claim that has onychomycosis, and we're seeking for it to cover just an infection of skin, those comments in the prosecution history would be limiting.

[00:37:41] Speaker 00:
They would be seen as limiting our scope of our claim.

[00:37:44] Speaker 05:
Do you think they qualify as a clear and unmistakable disclaimer?

[00:37:48] Speaker 00:
You know, it would be really close.

[00:37:50] Speaker 00:
It would be really close, and I would expect my opponent to argue it, that's for sure.

[00:37:54] Speaker 00:
And so I think that that's got to be part of this claim construction process when you have those statements that clearly define the invention in a very clear and intimate way in terms of penetrating the nail plate, permeating the nail plate, and getting to the seed of the disease at the nail bed.

[00:38:11] Speaker 00:
Going back to the skin question.

[00:38:12] Speaker 05:
Again, you're saying we don't necessarily need the nail bed.

[00:38:14] Speaker 00:
You don't necessarily need to know that.

[00:38:15] Speaker 05:
It does need to penetrate the keratin in the neck.

[00:38:18] Speaker 00:
That's right.

[00:38:19] Speaker 00:
That's right.

[00:38:20] Speaker 00:
Going back to the skin mycosis issue, if you look at column four, which I think is where you were, Judge Toronto, there's a definition of skin.

[00:38:35] Speaker 00:
And it's an overly broad definition, and perhaps it's even more confusing.

[00:38:39] Speaker 00:
This broad term skin is really used to indicate anything on the outer surface of the body.

[00:38:45] Speaker 00:
And it specifically says that it includes pilus, which is hair, nails, glandular species as appendages.

[00:38:55] Speaker 00:
And so when you're talking about superficial mycosis, you're not just talking about skin.

[00:39:00] Speaker 00:
You're talking about any type of infection on the surface of the body as opposed to a deep mycosis that would be internal, you know, in your organs or in your lungs or otherwise.

[00:39:13] Speaker 02:
Can I ask you a question about reissue?

[00:39:17] Speaker 02:
Absolutely.

[00:39:19] Speaker 02:
When you submitted your reissue application, did you say, here are claims that we want to cancel, here are claims that we want to amend, here are claims we want to add, or did the process not get far enough for you to do that, or what?

[00:39:36] Speaker 00:
So we filed our reissue application about a month after the petition was filed.

[00:39:43] Speaker 00:
And in it, we included a preliminary amendment that amended claims and added new claims.

[00:39:50] Speaker 00:
Actually, I'm sorry.

[00:39:50] Speaker 00:
I don't think we amended any claims.

[00:39:51] Speaker 00:
We kept claims one and two.

[00:39:53] Speaker 02:
You kept claims one and two.

[00:39:54] Speaker 02:
So you still want those?

[00:39:56] Speaker 00:
We definitely still want those.

[00:39:57] Speaker 00:
But after the final written decision, we assumed that the reissue would be lifted because every single other order and case in the docket had

[00:40:07] Speaker 00:
we filed a new application or a new preliminary amendment which canceled the two claims to get over the estoppel provisions and added a more narrow set of claims that focused specifically on just the nail plate and the nail bed.

[00:40:21] Speaker 00:
Thanks.

[00:40:23] Speaker 00:
If there are no further questions.

[00:40:24] Speaker 04:
Any more questions?

[00:40:25] Speaker 04:
Any more questions?

[00:40:27] Speaker 04:
Thank you.

[00:40:27] Speaker 04:
Thank you both.

[00:40:28] Speaker 04:
Thank you, Your Honor.

[00:40:29] Speaker 04:
This has taken on your submission.