[00:00:00] Speaker 03:
That leads us to our fourth case this morning, which is number 23-11-47, Spett versus Fates.

[00:01:03] Speaker 03:
Okay, Ms.

[00:01:04] Speaker 03:
Ahmadi.

[00:01:10] Speaker 00:
May it please the court.

[00:01:11] Speaker 00:
My name is Brittany Ahmadi and I represent Appellant Speck and Scheller.

[00:01:16] Speaker 00:
The board never should have allowed this interference to proceed for two independent reasons.

[00:01:21] Speaker 00:
First, the baits claims are prohibited by the one-year statutory bar against a party seeking to provoke an interference with an issued patent.

[00:01:30] Speaker 00:
Bates made his claims over five years after Speck's 305 patent issued.

[00:01:35] Speaker 00:
The only question is whether Bates can take advantage of what this court has called a limited exception to the statutory time bar on the ground that Bates' post-critical date claims do not differ from his pre-critical date claims in any material limitation.

[00:01:51] Speaker 02:
What do you think are the material differences between the pre-critical date claims and what I'll refer to as the copy claim?

[00:02:00] Speaker 00:
Thank you, Your Honor.

[00:02:01] Speaker 00:
So as we pointed out in our brief, all of Bates' earlier claims all exclude all containment material or any containment layer that incorporates the drug.

[00:02:10] Speaker 00:
So they relied on three different pre-critical date claims, and these are set forth in our blue brief and page 41.

[00:02:17] Speaker 00:
But in contrast, Bates' later claims, the post-critical date claims, only exclude a containment material atop the drug later.

[00:02:25] Speaker 00:
That means that the later claims are broader because they permit a containment layer

[00:02:29] Speaker 00:
that includes the drug.

[00:02:31] Speaker 00:
This is a material difference for two reasons.

[00:02:34] Speaker 00:
First, as the prosecution history for Bates' earlier claims confirms, during prosecution, Bates added the limitation requiring that the crackler... Okay, so it says that if the limitation is added during prosecution of a pampyri, that means it's material?

[00:02:50] Speaker 00:
So cases such as Adair B. Carter,

[00:02:52] Speaker 00:
and this court's decision in Parks Define say that there's a presumption that the limitation is material where it has been added to address an examiner's rejection.

[00:03:03] Speaker 00:
And we believe those cases apply here with respect to that limitation where Bates during profication stated expressly that the claims require that the Paclitaxel or the drug

[00:03:15] Speaker 00:
need not be incorporated into a containment layer for sufficient adherence for delivery and deployment.

[00:03:20] Speaker 00:
And emphasize that the prior, instead, emphasized containment of its active drug.

[00:03:26] Speaker 00:
And I think there's a second reason here why these differences are material.

[00:03:30] Speaker 00:
And that's because, and this evidence was not disputed before the board, that the difference between excluding a containment layer on top of a drug and excluding all containment layers

[00:03:41] Speaker 00:
actually makes a difference to how the products operate.

[00:03:44] Speaker 00:
As SPEC's expert explained before the board, So that's precisely the issue here.

[00:03:54] Speaker 00:
So Bates' earlier claims were narrower in excluding all containment material.

[00:03:59] Speaker 00:
Bates broadened their claims to exclude only containment material

[00:04:04] Speaker 00:
atop the drug in an attempt to capture Medtronic's commercial product.

[00:04:08] Speaker 00:
So the way that Medtronic's commercial product works here is it includes the drug within an excipient, and the earlier claims excluded, it's undisputed, excluded a containment layer at all, whether it contained the drug or was on top of the drug.

[00:04:22] Speaker 00:
Bates thought these broader claims to exclude a containment layer on top, as opposed to... But if there was one that included the Pacna taxol,

[00:04:32] Speaker 02:
It was either mixed with it.

[00:04:34] Speaker 00:
Correct.

[00:04:34] Speaker 02:
That would infringe one of these sets of claims, I guess the later claims, but not the earlier claims.

[00:04:40] Speaker 00:
That certainly baits his argument here.

[00:04:43] Speaker 01:
What do you do with the language from the Berger case?

[00:04:47] Speaker 01:
I'm referencing page 982 of 279, Fed 3rd.

[00:04:51] Speaker 01:
I'm sure you're familiar with this language.

[00:04:54] Speaker 01:
Talking about if all material limitations of the copied claim are present in or necessarily result from the limitations of the prior claims.

[00:05:02] Speaker 01:
when the copied claim is entitled at the earlier effective date.

[00:05:05] Speaker 01:
That seems to be a one-way test in a way that would indicate that broader claims would not run afoul of 135B.

[00:05:18] Speaker 01:
That's the way I read that language.

[00:05:20] Speaker 01:
How do you deal with that language?

[00:05:22] Speaker 00:
So the Burger Court did use that language, Your Honor, but I think two things are important here.

[00:05:27] Speaker 00:
First, the Burger Court recognized, as prior cases had laid out, like the Sulego case,

[00:05:32] Speaker 00:
the Corbett case and the Sitz case, that a claim, in order to avoid the statutory time bar, the applicant must show that the later file claims, quote, does not differ from an earlier claim in any material limit.

[00:05:46] Speaker 01:
Well, that's what Corbett and Stalegos say, but I don't know how you can square that with the language that Berger uses here.

[00:05:54] Speaker 01:
How do you explain language that seems to say the opposite?

[00:06:00] Speaker 00:
I think the language that Your Honor was directing me to is best read in the context of the issue in that particular case, where the issue was that the applicant had narrowed the claim during prosecution, and that was sufficient to resolve the issue.

[00:06:14] Speaker 00:
And I think the other question that the Berger Court was dealing with was whether you need to compare the applicant's two sets of claims, so the pre- and post-Critical Day claims, or whether you're comparing the patentee's claim with the applicant's claim.

[00:06:28] Speaker 00:
And the court was making clear that the comparison should be between the pre- and post-critical date claims.

[00:06:35] Speaker 00:
So I think when reading that in context of the particular issues in that case, that explains why the court stated that, because it was sufficient to resolve the issue.

[00:06:43] Speaker 00:
But if you look back at cases like Stilago and SITS, the court is very clear in those cases.

[00:06:50] Speaker 00:
For example, Stilago states, in quote, claims are not for substantially the same subject matter.

[00:06:56] Speaker 00:
if one of them contains one or more material limitations which are not found in the other.

[00:07:01] Speaker 01:
And that is, in your view, the two-way test articulated without reference to the two-way or one-way.

[00:07:07] Speaker 00:
That's correct, Your Honor.

[00:07:08] Speaker 00:
It requires looking at both sets of claims, the pre-critical date claims, to assess are there limitations in the pre-critical date claims not present in the post-critical date claims, and also looking at the post-critical date claims to say are there limitations in those claims not present in the pre-critical date claim.

[00:07:24] Speaker 00:
Both of those analyses are necessary in order to determine whether there's a material difference.

[00:07:30] Speaker 00:
And that makes sense here because you're talking about what it should be a statute of repose to provide patent owners with certainty in their patent rights.

[00:07:38] Speaker 00:
And where you have a statute of repose that bars on its face any claims that are past the one-year bar, it makes sense to look narrowly at whether there are, in fact, differences between those claims that are material whichever way they go.

[00:07:51] Speaker 00:
in order to assess whether that judicial exception to the statutory bar should apply.

[00:07:55] Speaker 00:
And I think this is further bore out in the CCPA's decisions and in Gray-Fitz, as well as in Corbett.

[00:08:04] Speaker 00:
In Sitz, the court held that it's necessary to compare the structures recited specifically in the earlier claim with the broader recitations of the later claim, and ultimately concluded that the two claims were not directed to substantially the same subject matter.

[00:08:20] Speaker 00:
So in essence, the court there applied a two-way test instead of applying the precedent from Stilago.

[00:08:27] Speaker 00:
Similarly in Corbett, there were four sets of different pre-critical date claims.

[00:08:32] Speaker 00:
For the fourth set of claims, the court looked at those claims and it determined that they were materially different because

[00:08:38] Speaker 00:
The earlier claims defined the invention with some particularity, and that was the language that the court used.

[00:08:46] Speaker 00:
In other words, the earlier claims were narrower than the later, broader claims.

[00:08:51] Speaker 00:
So in both of those cases, or all three of those cases, Stalago, Sitz, Corbett require looking at both sets of claims to compare them.

[00:08:58] Speaker 02:
If we were to hold that the 135B1R applied to this interference, should we address the written description issue?

[00:09:06] Speaker 00:
If the 135 B time bar applies, then this interference never should have proceeded in the first place.

[00:09:12] Speaker 00:
And so the court doesn't need to address it.

[00:09:13] Speaker 00:
Well, there are separate motions.

[00:09:14] Speaker 02:
See, this is what I was thinking.

[00:09:15] Speaker 02:
There are separate motions.

[00:09:16] Speaker 02:
One is a motion on written description.

[00:09:18] Speaker 02:
One is a motion under the 135 B1 bar.

[00:09:21] Speaker 02:
Do they both have to be addressed?

[00:09:24] Speaker 02:
It's not entirely clear to me.

[00:09:26] Speaker 00:
So I apologize for that, Your Honor.

[00:09:29] Speaker 00:
So they are separate what the board calls threshold motions.

[00:09:32] Speaker 00:
And so under either motion, if this court were to reverse,

[00:09:35] Speaker 00:
That means that Bates would not have had what the board called standing in the interference, and it should not have proceeded.

[00:09:42] Speaker 00:
And so either issue is sufficient to resolve.

[00:09:45] Speaker 01:
But there's a third option, which is that even under the 135B issue, we could remand.

[00:09:54] Speaker 01:
Presumably, if we were to decide the written description issue, that would be the end of the case.

[00:10:02] Speaker 01:
So there's different possible outcomes.

[00:10:05] Speaker 01:
I think, Your Honor, so this court has said that the 135B comparison of the claims is a legal issue, reviewed de novo, so I think this court could... Right, but in terms of deciding whether or not the application of the two-way test would result in your prevailing, if that were the test that we were to adopt,

[00:10:27] Speaker 01:
It seems to me at least conceivable that that would be a question that would be to a remand.

[00:10:31] Speaker 01:
Your brief seems to recognize that fact because you say you will reverse a remand.

[00:10:36] Speaker 02:
That's correct.

[00:10:37] Speaker 01:
That is an option as well.

[00:10:39] Speaker 02:
It also seems to me that you might want to have consideration of this written description issue.

[00:10:44] Speaker 02:
Am I wrong?

[00:10:45] Speaker 02:
Why would you not want to have that considered?

[00:10:47] Speaker 02:
I mean, you're still going to have an application, right?

[00:10:53] Speaker 00:
So the posture is that Bates's application is not an issued patent.

[00:10:59] Speaker 00:
And so if this court could resolve the issue on either grounds, however, if the court elects to determine the written description issue, even if it determines that the claims were time barred, we certainly would not oppose that result.

[00:11:15] Speaker 01:
On the written description issue, I take it that that is not a de novo issue.

[00:11:20] Speaker 01:
That's a factual question on which

[00:11:23] Speaker 01:
the board is entitled to a substantial evidence review.

[00:11:27] Speaker 01:
Would you agree?

[00:11:29] Speaker 01:
That's correct.

[00:11:31] Speaker 01:
And so the question then is, is there enough in the application, the Bates application, to suggest that there is written description for the smooth surface embodiment, for lack of a better term.

[00:11:47] Speaker 01:
And I would wonder,

[00:11:51] Speaker 01:
Moving, for example, to I think it's paragraph 19, I guess it is, the end of paragraph 19 talking about the balloon, again, to call it embodiment, suggests having a smooth or slippery surface.

[00:12:12] Speaker 01:
Why isn't that some indication?

[00:12:14] Speaker 01:
Admittedly, it's a long application.

[00:12:16] Speaker 01:
There are not a lot of references to smooth in it, but that's one of them.

[00:12:20] Speaker 01:
Why isn't that enough?

[00:12:22] Speaker 01:
Even with the word seized on that and found that that was enough to constitute written description, why isn't that enough?

[00:12:28] Speaker 00:
So I think when you read the specification as a whole and in context, it's very clear that that is a reference to the balloon before it has been roughened, which is described throughout the specification as

[00:12:39] Speaker 00:
the present invention and the specific improvement of the present invention?

[00:12:44] Speaker 01:
Where is the best place in the specification?

[00:12:47] Speaker 01:
I understand that argument.

[00:12:48] Speaker 01:
You made it in your brief.

[00:12:50] Speaker 01:
But what was not clear to me is whether the reference to the balloon as smooth of the substance from which the balloon is made, as smooth and slippery, was necessarily before the roughening.

[00:13:08] Speaker 01:
Where is the best reference?

[00:13:09] Speaker 01:
in the application to the roughening being a step that's taken after the construction of the smooth surface balloon.

[00:13:21] Speaker 00:
So I would direct, Your Honor, to a couple of places in the specification.

[00:13:25] Speaker 00:
If you take a look at, and this is Appendix 6060, Paragraph 68 of the specification, it states that the initial surface of the base material prior to roughening... Paragraph 60... Oh, I'm sorry, Your Honor.

[00:13:38] Speaker 00:
Paragraph 68.

[00:13:38] Speaker 00:
Yeah.

[00:13:39] Speaker 00:
It is a 68.

[00:13:40] Speaker 00:
68, yes, at Appendix 6060.

[00:13:46] Speaker 00:
The specification makes clear where it states

[00:13:49] Speaker 00:
the initial surface of the base material prior to roughening or texturing may be smoother than the desired surface roughness.

[00:13:57] Speaker 00:
So there's an acknowledgement there that the starting out surface may be smooth and then it's roughened.

[00:14:03] Speaker 00:
And then I would also direct your honor to paragraph 19 and reading that in conjunction with paragraph 14 and this is at appendix 6041 and 6039.

[00:14:14] Speaker 00:
At paragraph 19 it states

[00:14:16] Speaker 00:
the balloon material is treated, and that's the important language here, so as to be capable of delivering the bioactive material to the treatment site.

[00:14:25] Speaker 00:
And if you take a look at paragraph 14, where it discusses treatment of the medical device,

[00:14:30] Speaker 00:
It states very clearly that you're attaining a desired surface roughness or texturing on the surface of the device by whatever treatment of the surface.

[00:14:39] Speaker 00:
And it goes on to say that the degree of surface treatment is controlled to provide sufficient adhesion of the bioactive material to the surface device.

[00:14:48] Speaker 02:
Some of the techniques that are described in this application for roughening make sense to me.

[00:15:00] Speaker 02:
not a person who knows family art.

[00:15:03] Speaker 02:
So I'm going to give that caveat.

[00:15:04] Speaker 02:
But they make sense to me with respect to a metal surface, say, for a step.

[00:15:08] Speaker 02:
But they might not necessarily make sense with respect to a blow of the materials described in paragraph 19.

[00:15:18] Speaker 02:
For example, the abrading, the etching, the abrasive grit.

[00:15:25] Speaker 00:
Is there anything to help explain that?

[00:15:30] Speaker 00:
So I think throughout the specification, I believe it's paragraphs, I think it's 61 through 64, where it discusses the various processes by which the surface can be roughened.

[00:15:43] Speaker 00:
It does describe that there's various ways that this can be accomplished, and so there's not one particular, I think the one you referenced, that would be necessary to obtain the roughening.

[00:15:53] Speaker 00:
But I think what's important here is that throughout the specification, there is a discussion of the present invention

[00:16:00] Speaker 00:
involving applying a roughening to the device surface before the drug is being applied.

[00:16:06] Speaker 03:
Doesn't it also suggest that that roughening could be to the stent rather than to the balloon?

[00:16:14] Speaker 00:
There is a discussion of both the balloon and the stent, but I think if you look at the specification, it is agnostic as to whether or not it's the balloon or the stent.

[00:16:24] Speaker 00:
So there's language in the specification.

[00:16:26] Speaker 00:
describing it as the medical device broadly, and it goes on to explain that that could be a balloon or a stent, but the medical device is what has a roughened or textured surface in the specification.

[00:16:39] Speaker 00:
And so I think if you look at the specification as a whole, particularly looking at the description of the prior and the fact that there was a containment layer and what they were trying to do to overcome that, which is described in paragraph 14,

[00:16:56] Speaker 00:
as the specific improvement of the present invention is to attain a desired surface roughness or texturing in order to approve adhesion of the drug as an alternative to using a containment layer.

[00:17:08] Speaker 00:
And that's described in the background of the invention as well as in the summary of the invention.

[00:17:12] Speaker 02:
So you've got a little bit of that difficult battle here because of the substantial evidence.

[00:17:18] Speaker 02:
And even if the evidence is an equipoise on this new blue surface, what do you think is your strongest evidence for saying the board's reading just no reasonable person could interpret it the way the board did?

[00:17:30] Speaker 00:
I think the strongest evidence here is if you take a look at paragraph 10 and paragraph 11 of the specification, which describes the

[00:17:38] Speaker 00:
issues that were present in the prior art and the issues specifically with using containment material and the problems there.

[00:17:45] Speaker 00:
And then you take a look at paragraph 14 in the language, the specific improvement of the present invention entails attaining a desired surface roughness or texturing and then applying the drug to that textured surface.

[00:17:59] Speaker 00:
Both of those in conjunction make very clear that the invention that the patentee was seeking to protect here was an invention

[00:18:06] Speaker 00:
of applying the drug to a rough-and-detection surface as an alternative to using what came before, which was using a containment material.

[00:18:17] Speaker 00:
And I see that I am into my rebuttal time.

[00:18:20] Speaker 03:
You have two minutes for rebuttal.

[00:18:21] Speaker 00:
Thank you, Your Honor.

[00:18:25] Speaker 03:
Mr. Hartz.

[00:18:30] Speaker 04:
Good morning, Your Honors, and may it please the Court.

[00:18:32] Speaker 04:
I'm Blake Hartz here for Bates.

[00:18:34] Speaker 04:
I want to talk about 135B first a little bit.

[00:18:39] Speaker 04:
But before I do that, both of these are essentially factual questions, whether the differences are material and whether there's written description support.

[00:18:46] Speaker 04:
And the record before the board provides a chance of evidence.

[00:18:49] Speaker 03:
That's not quite true.

[00:18:50] Speaker 03:
I mean, in terms of whether we apply a one-way test or a two-way test, that's a legal issue, right?

[00:18:56] Speaker 04:
how to apply the test could be a legal issue, but whether those differences are material or not is a factual statement.

[00:19:03] Speaker 04:
That's our position.

[00:19:05] Speaker 03:
Okay, but the first question is whether you apply a one-way test or a two-way test.

[00:19:11] Speaker 03:
And there seems to be some pretty strong support in the earlier cases for applying a two-way test.

[00:19:21] Speaker 03:
And that would seem to make sense

[00:19:23] Speaker 03:
In terms of the policy here, why should an amended claim be broader when the window comparison is a two-way test itself?

[00:19:35] Speaker 03:
So what's the rationale for applying a one-way test?

[00:19:41] Speaker 04:
Well, I'll push back on what these older cases say.

[00:19:44] Speaker 03:
If you look at the Stilego case, some of the... No, but we'll get to that.

[00:19:50] Speaker 03:
I'm first asking in terms of the policy of the statute, after all this exception to the time bar is a judicially created exception, right?

[00:20:00] Speaker 03:
And so it's based on policy considerations.

[00:20:04] Speaker 03:
And what's the policy consideration that suggests we shouldn't be applying the two-way test to the filings outside the window?

[00:20:12] Speaker 03:
That seems on its face not to be very sensible.

[00:20:16] Speaker 04:
Your Honor, I would suggest that it's not a judicially created exception.

[00:20:19] Speaker 04:
It's in the statute.

[00:20:20] Speaker 04:
You can have a claim for substantially the same subject matter.

[00:20:23] Speaker 02:
But if it's substantially the same subject matter, that should require you to look at all the differences between the claims, including elements that have been added to the claim and elements that have been

[00:20:33] Speaker 02:
that have been subtracted from the claim, right?

[00:20:35] Speaker 02:
It's a different way of stating the two-way test.

[00:20:39] Speaker 02:
You can't just look at whether the things in the new claim actually had support in the old claim.

[00:20:45] Speaker 02:
You have to look at whether there's also things in the new claim that are missing from the old claim.

[00:20:51] Speaker 02:
Why wouldn't you have to do that?

[00:20:53] Speaker 02:
When the statute says substantially the same invention,

[00:20:58] Speaker 04:
Well, Your Honor, the material differences test gets at that issue, but it doesn't say you have to explicitly walk through this in a two-way comparison.

[00:21:10] Speaker 04:
I mean, they just say, look at the point.

[00:21:11] Speaker 02:
OK, so one question that was different.

[00:21:12] Speaker 02:
I want to go back to George Dike's question.

[00:21:14] Speaker 02:
What is the policy reason why we would only apply a one-way test, given the language of the statute?

[00:21:22] Speaker 04:
The policy reason?

[00:21:25] Speaker 04:
Yeah.

[00:21:30] Speaker 04:
I guess it would be that there's always been this equitable notion, even before the statute existed, that allows you to look to a prior claim.

[00:21:39] Speaker 04:
And they may not have been as specific about reading the prior claim forward and requiring support in that way.

[00:21:46] Speaker 04:
But I just think the historical practice has always permitted this.

[00:21:51] Speaker 02:
Are you aware of any cases where claims were

[00:21:59] Speaker 02:
broadened to copy the count in interference, and there wasn't a two-way test applied when Section 135B was invoked.

[00:22:13] Speaker 04:
Sorry, what was the first part of that question?

[00:22:17] Speaker 02:
So my question was, are you aware of any cases that have facts like this one?

[00:22:21] Speaker 02:
What makes this case different than some of the prior cases is that the later claim

[00:22:27] Speaker 02:
the post-critical date claim is broader than the pre-critical date claim.

[00:22:32] Speaker 02:
Are you aware of any cases that involve those facts and only apply one-way tests?

[00:22:37] Speaker 04:
Well, you could look at Stalego.

[00:22:38] Speaker 04:
There's three items in Stalego's claim that aren't in the count, and then they find that that's essentially the same.

[00:22:46] Speaker 04:
They say that's the essence.

[00:22:48] Speaker 01:
But on materiality, as I recall, Stalego, right?

[00:22:52] Speaker 01:
In other words, they weren't saying that you could have a material expansion of the later claim.

[00:23:00] Speaker 01:
And that would be OK, which would be true if you had a one-way test.

[00:23:08] Speaker 01:
I have the same question that Judge Dyke and Judge Still have, which is, would the one-way test that you're advocating result in having no bounds

[00:23:19] Speaker 01:
on how expansive the later claim could be.

[00:23:24] Speaker 01:
No, I don't think it would go that far.

[00:23:26] Speaker 01:
What would be the way you would address that question?

[00:23:31] Speaker 01:
If you say that the one-way test is the correct test for determining whether there's a material difference.

[00:23:39] Speaker 04:
Well, a lot of the older cases focus on whether there are patentable distinctions between the two sets of claims.

[00:23:45] Speaker 04:
And I don't know that fellow circuit cases have gone that far, but the older CCPA cases, they talk about whether this is a distinct invention from a patentability perspective.

[00:23:55] Speaker 04:
So that would be one way to look at that.

[00:23:58] Speaker 04:
And if you apply that kind of situation here, the later claims of baits involved in the interference and terminal disclaimers entered over

[00:24:07] Speaker 04:
these very same claims from the 149 patent that we're relying on as providing pre-critical date support.

[00:24:14] Speaker 04:
So if that's a way to get, put some more meaning into what materiality means in the context of what this test has been discussed as, that would be one way to get there.

[00:24:30] Speaker 02:
If we think that the two-way test should apply and that's the

[00:24:34] Speaker 02:
our case law has applied because it's looking at all material differences.

[00:24:38] Speaker 02:
Why aren't the differences between the claims here material?

[00:24:44] Speaker 04:
Well, we put evidence in from expert testimony who looked at them and said, I don't think that these are substantial differences.

[00:24:51] Speaker 04:
These are essentially the same.

[00:24:54] Speaker 04:
evidence they pointed to, this commercial embodiment that they say is covered by one set and not the other, we don't agree with that position.

[00:25:02] Speaker 02:
We think that what they're... What about holdings, if it's in there, that if a claim is modified to overcomparer that the, you know, by adding a particular limitation, as was the case here, that is a material limitation.

[00:25:22] Speaker 04:
Yeah, the cases that I've seen, none of them are doing that when they're looking at the pre-critical date claim.

[00:25:28] Speaker 04:
And we went through that in the briefing.

[00:25:31] Speaker 04:
as defining that as material.

[00:25:34] Speaker 04:
If you look at a case like Wetmore, it had a narrower limitation in the pre-critical date claim.

[00:25:40] Speaker 04:
And then in the later claims or in the count, that limitation of fusible is no longer included.

[00:25:47] Speaker 04:
And so that supports this broadening concept that there can be, it's not a material difference necessarily to have a broader claim later.

[00:25:56] Speaker 03:
Did the board say that applying the two-way test there's a lack of materiality?

[00:26:06] Speaker 04:
They said that they applied the test from Berger.

[00:26:11] Speaker 03:
Okay, but we raised questions as to whether the statement of the Berger test is really a statement in a different context than here.

[00:26:20] Speaker 03:
Let's assume for the moment that

[00:26:23] Speaker 03:
we're past the point and that we hold in accordance with prior cases and the policy that there's a two-way test here.

[00:26:31] Speaker 03:
What my question is on that assumption, did the board address the question of materiality?

[00:26:42] Speaker 04:
They looked at the evidence presented to it and they said these differences are not material.

[00:26:48] Speaker 03:
That doesn't answer my question.

[00:26:51] Speaker 03:
My question is, did they say, applying a two-way test, which they rejected, that there was a lack of materiality?

[00:26:59] Speaker 04:
They did not explicitly apply a two-way test, Your Honor.

[00:27:02] Speaker 03:
OK.

[00:27:02] Speaker 04:
Yeah.

[00:27:04] Speaker 04:
And this relates to a point you asked Judge Bryson about, whether remand would be appropriate.

[00:27:11] Speaker 04:
I think if you were to decide that two-way test applies, I think it'd be

[00:27:17] Speaker 04:
in the board's position to make that decision based on the facts in front of it in the first place.

[00:27:22] Speaker 04:
So if you were going to change the law or, I guess, restate the law here for them, it'd probably be their place to address that in the first instance.

[00:27:33] Speaker 03:
And then another point... What's the argument as to why there's a lack of materiality here applying a two-way test?

[00:27:40] Speaker 04:
Because they're substantially the same.

[00:27:44] Speaker 04:
I mean, that's the testimony that

[00:27:46] Speaker 04:
that's before the board in Dr. Burns' declaration.

[00:27:51] Speaker 04:
He said, you know, a lot of these deal with excluding containment materials or in certain layers.

[00:27:56] Speaker 04:
It's basically the same subject matter.

[00:27:59] Speaker 04:
I don't think that that is just a standing difference.

[00:28:01] Speaker 04:
The subject matter, where is that testimony?

[00:28:05] Speaker 04:
Dr. Burns, appendix 3781 to 85, that's where he gets into it.

[00:28:14] Speaker 03:
3781.

[00:28:15] Speaker 03:
Which specific page?

[00:28:35] Speaker 04:
So if you look at 84 to 85, so you have 24 of Dr. Byrne's declaration, he says, I understand SPEC is continuing.

[00:28:45] Speaker 04:
Difference, I don't think that's material.

[00:28:47] Speaker 04:
I'm sorry, which paragraph?

[00:28:49] Speaker 02:
Paragraph 24.

[00:28:49] Speaker 02:
And I apologize, which page of the appendix are you on?

[00:28:52] Speaker 04:
Yeah, 3784.

[00:28:54] Speaker 02:
Thank you.

[00:28:55] Speaker 04:
It's 42.

[00:29:08] Speaker 04:
And he talks about the emphasis of the limitations is excluding containment materials or layers, and that's substantially the same in both sets of claims.

[00:29:17] Speaker 04:
And if you look at language from cases like Stolago, it talks about the ultimate question is whether the specific differences of material, and you decide that on the facts of each case.

[00:29:32] Speaker 04:
And they talk about the essence of the claim subject matter.

[00:29:36] Speaker 04:
The same sort of thing is in Thompson.

[00:29:40] Speaker 04:
Substantially the same mechanism, substantially the same result.

[00:29:44] Speaker 04:
And so those are the types of standards to use even if you're looking at how to treat this materiality question.

[00:29:53] Speaker 04:
A couple points to make on written description.

[00:29:59] Speaker 01:
What do you think is the best source for your argument on written description in the application?

[00:30:06] Speaker 01:
What should we focus on as the best indication that the smooth surface was in fact contemplated?

[00:30:15] Speaker 01:
Paragraphs 13, 14, and 19.

[00:30:17] Speaker 01:
Okay, now 14, I guess it is, is the one that says the present invention and talks about roughening.

[00:30:23] Speaker 01:
So that is not helpful to you.

[00:30:24] Speaker 01:
Was it the person at the end of that paragraph that talks about the components having smoother slippery surfaces?

[00:30:33] Speaker 04:
Well, the beginning of 14 says the present invention such as a balloon is coated with the drug.

[00:30:41] Speaker 04:
And it has this whole page where it doesn't talk about anything about the texturing.

[00:30:49] Speaker 04:
So none of that is tied to having a texture on the balloon surface.

[00:30:53] Speaker 04:
And then it talks about a roughening

[00:30:57] Speaker 01:
as part of what's going on here.

[00:30:59] Speaker 01:
I said 14.

[00:31:01] Speaker 01:
I meant 19.

[00:31:01] Speaker 01:
The end of 19 has the language that struck me as being most problematic for you.

[00:31:11] Speaker 04:
Problematic?

[00:31:12] Speaker 01:
Yeah.

[00:31:15] Speaker 04:
I think 19 supports us.

[00:31:16] Speaker 04:
It says, maybe made of material of a smoothest quality.

[00:31:21] Speaker 01:
Yes, you're right.

[00:31:21] Speaker 01:
You're right.

[00:31:22] Speaker 01:
It is 14 that is a problem again.

[00:31:25] Speaker 01:
But the language, the specific improvement of the present invention, the breadth of that sentence seems to be problematic.

[00:31:34] Speaker 01:
Yes, you're right.

[00:31:34] Speaker 01:
The snooze reference is the most helpful.

[00:31:38] Speaker 04:
This application uses the present invention in a number of different ways.

[00:31:42] Speaker 04:
It's not always in reference to roughening.

[00:31:44] Speaker 04:
If you look at the beginning of 14, it says the present invention is a balloon coated.

[00:31:49] Speaker 04:
If you look at the second sentence of the summary, which is on Appendix 60 or 37, paragraph 13, in one embodiment, it's an expandable balloon to which a bioactive material is applied.

[00:32:04] Speaker 04:
There are other aspects where the invention is talking about a method of treatment.

[00:32:08] Speaker 04:
The invention is a method of making something.

[00:32:11] Speaker 04:
So just using the present invention is not limiting to one specific embodiment or configuration in this case.

[00:32:21] Speaker 01:
And what is the distinction that you think, reading the application as a whole, that the application is drawing between what needs to be roughened and what can be smoothed?

[00:32:35] Speaker 01:
Are they talking about the stamp versus

[00:32:38] Speaker 01:
the balloon, or how would you divide the universe of what's rough and what can be smooth?

[00:32:43] Speaker 04:
Yeah, the explicit examples where there's roughening are all talking about stents in the application.

[00:32:50] Speaker 04:
None of the detailed examples talk about roughening the balloon surface.

[00:32:57] Speaker 04:
So if you look at drawing the line that way, they're talking about different ways of having the material in the device.

[00:33:05] Speaker 03:
Well, and they suggest that roughening the stent

[00:33:07] Speaker 03:
surface would be sufficient.

[00:33:12] Speaker 03:
It suggests that ruffling of the stint surface alone would be sufficient, right?

[00:33:20] Speaker 04:
Yes, for those embodiments.

[00:33:22] Speaker 04:
The claims we're dealing with here aren't actually two stints.

[00:33:25] Speaker 04:
It's all about balloon devices.

[00:33:31] Speaker 03:
And then one more thing on what you... I'm sorry.

[00:33:36] Speaker 03:
Could you explain that last comment?

[00:33:37] Speaker 03:
Because I'm not sure that I understood that.

[00:33:40] Speaker 03:
The claims that we're talking about here.

[00:33:41] Speaker 04:
The involved claims talk about a balloon catheter device.

[00:33:48] Speaker 04:
They don't talk about a stent.

[00:33:51] Speaker 03:
I mean, there might be some dependents... They don't have a stent in addition to the balloon, is what you're saying?

[00:33:55] Speaker 04:
There may be a few dependent claims that talk about a stent.

[00:33:58] Speaker 04:
stent mounted, but the main independent claims we're talking about are all balloon catheter.

[00:34:03] Speaker 02:
Well, usually there's a phrase, balloon catheter, that automatically means to a person where there's filming art that there's no stent.

[00:34:11] Speaker 02:
Is that what you're saying?

[00:34:13] Speaker 02:
I understand what you're saying.

[00:34:16] Speaker 02:
I'm going back to looking at the claim.

[00:34:19] Speaker 02:
The preamble says balloon catheter medical device.

[00:34:22] Speaker 02:
So does a person who has a medical device understand that to not include a stent?

[00:34:28] Speaker 01:
I had always thought, you can correct me if I'm wrong, but from previous cases I thought that the catheter, even a balloon catheter, would go through the vein or artery and then the balloon would expand and sometimes there would be an expandable stent around the balloon which would be placed by expanding the balloon and then you reduce the balloon again and the stent stays placed.

[00:34:53] Speaker 04:
That is a common procedure, Your Honor.

[00:34:55] Speaker 04:
You can also have a procedure where the balloon is inflated

[00:34:58] Speaker 04:
and then removed and no stent is placed.

[00:35:01] Speaker 01:
Right.

[00:35:01] Speaker 01:
The fact that it says balloon catheter doesn't necessarily mean and no stent.

[00:35:09] Speaker 03:
Right.

[00:35:10] Speaker 03:
But in these claims that talk about the balloon without mentioning the stent, to the extent that we read the specification saying some part of the structure has to be roughened, in those claims that would seem to mean the balloon since there's no specific mention of the stent.

[00:35:27] Speaker 03:
Is that fair?

[00:35:33] Speaker 04:
I think so, but I wouldn't agree with you that you should read the specification of the claims that way.

[00:35:38] Speaker 04:
But if you were going to say it needs to be roughened, I don't think that there's another way to get there.

[00:35:43] Speaker 04:
Some of the independent claims just have a balloon listed.

[00:35:49] Speaker 04:
And the only other thing I was going to mention is if you were inclined to remand or

[00:35:56] Speaker 04:
do something on the written description other than affirm, I'll point out that the board denied the motion on written description without us having a chance to respond.

[00:36:08] Speaker 04:
So I don't think you could outright reverse.

[00:36:11] Speaker 04:
We would need to have an opportunity to present our case to the board on that.

[00:36:17] Speaker 03:
Okay.

[00:36:17] Speaker 03:
Yep.

[00:36:17] Speaker 03:
All right.

[00:36:17] Speaker 03:
Thank you.

[00:36:20] Speaker 03:
Ms.

[00:36:21] Speaker 03:
Amani, you have two minutes.

[00:36:25] Speaker 03:
Could you address the remand question, particularly the last point that Mr. Hartz made and also his reference to the expert testimony in paragraph 24 beginning on 3784?

[00:36:41] Speaker 00:
Yes, Your Honor.

[00:36:42] Speaker 00:
With respect to the written description issue, I'll start with the expert testimony.

[00:36:46] Speaker 00:
If you take a look at paragraph 24, which counsel pointed, Your Honor, to, I think there's two things that are notable about that paragraph.

[00:36:54] Speaker 00:
It is wholly conclusory in the conclusion.

[00:36:57] Speaker 00:
All the experts stated was, I do not see a material difference between these phrases.

[00:37:02] Speaker 00:
That was the extent of the analysis.

[00:37:04] Speaker 00:
And then the second piece is that the end of that paragraph is essentially applying the one-way test, which we think is erroneous.

[00:37:12] Speaker 00:
And so I don't believe that that expert testimony is sufficient to address this particular issue that council has raised with respect to a remand.

[00:37:24] Speaker 00:
I think if you look in contrast to our expert's declaration, which is at appendix 6578 and 6579, there's detailed information about the differences between including the drug within a containment layer and including the containment layer atop the drug.

[00:37:49] Speaker 00:
And the expert explains why those are material differences in terms of

[00:37:54] Speaker 00:
how the product operates, including how Medtronic's commercial product operates.

[00:37:58] Speaker 00:
And there was no response to that detailed testimony.

[00:38:02] Speaker 02:
Does your materiality argument require reliance on your expert, or do you have a separate argument based on the prosecution history?

[00:38:10] Speaker 00:
That's correct, Johnna.

[00:38:11] Speaker 00:
We think either argument shows that these claims are materially different.

[00:38:15] Speaker 00:
And Bates' own statements during the prosecution history indicate that there is a material distinction between the pre-critical date claims here and the post-critical date claim.

[00:38:25] Speaker 03:
What about Mr. Hartz's suggestion that they didn't have an opportunity to respond to the motion?

[00:38:30] Speaker 00:
That's correct, Your Honor.

[00:38:31] Speaker 00:
The board did address written description without receiving full briefing on that issue.

[00:38:38] Speaker 00:
The other point I would just like to make in my rebuttal here is with respect to the policy considerations in particular that the court raised.

[00:38:47] Speaker 00:
If there were only a one-way test and an applicant were allowed to essentially broaden their claims, it would allow for the exact type of gamesmanship that we have here where an applicant can materially broaden the claims and seek to capture subject matter that they didn't originally invent.

[00:39:03] Speaker 03:
And here, the applicant- I believe it after the critical day.

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

[00:39:08] Speaker 00:
That's correct, Your Honor.

[00:39:09] Speaker 00:
And the last point that I'll make, and I see that I'm almost out of time, the last point that I'll make is that everywhere where the patent discusses, and this is on the written description issue, discusses the manufacture of the device as opposed to its placement or insertion into a patient.

[00:39:26] Speaker 00:
it describes it as applying the drug to a roughened or textured surface.

[00:39:31] Speaker 00:
So there may be other descriptions in the patent that don't refer to the surface of the device because it's talking about insertion into a patient, but everywhere where the patent describes the manufacturer and how the drug is ultimately applied to the device, it describes it as being applied to a roughened surface.

[00:39:49] Speaker 00:
And with respect to the distinction between the stent and the balloon, if you take a look at paragraph 16,

[00:39:55] Speaker 00:
the paragraph is broad in that it states the medical device of the present invention, and it includes roughening.

[00:40:03] Speaker 00:
So whether it's the balloon or the stent, and I think Judge Dyke, Your Honor, pointed out that if the claims here are only to a balloon, then it's that device that's at issue and must have a reference for this.

[00:40:13] Speaker 02:
Do you think the claims are only to a balloon?

[00:40:16] Speaker 02:
Do you think the claims are only to a balloon?

[00:40:18] Speaker 02:
But they're comprising claims.

[00:40:20] Speaker 02:
They don't mention the stent, but they are comprising claims.

[00:40:24] Speaker 00:
So I will say, Your Honor, that my understanding is that has been Bates's position.

[00:40:29] Speaker 00:
That's been what?

[00:40:30] Speaker 00:
Bates's position.

[00:40:31] Speaker 00:
But we, of course, reserve the right to disagree to the extent that this patent is ultimately issued.

[00:40:38] Speaker 00:
Unless Your Honors have further questions, thank you.

[00:40:42] Speaker 03:
Thank you.

[00:40:42] Speaker 03:
Thank both counsel.

[00:40:43] Speaker 03:
The case is submitted.

[00:40:44] Speaker 03:
That concludes our session for this morning.