[00:00:00] Speaker 04:
The case for argument is 21-2356, Medtronic vs. Teleflex Innovation.

[00:00:10] Speaker 03:
The board legally aired in finding that Teleflex reduced the practice, the guideline or rapid exchange catheter before the critical date of September 23rd, 2005.

[00:00:27] Speaker 03:
With that error, the board allowed Teleflex to take for itself what the ETO patent put in the public domain first.

[00:00:34] Speaker 03:
Within a slim nine-month window, the board found that Teleflex proved conception, assembly, testing, and that its rapid exchange catheter worked for its intended purpose.

[00:00:45] Speaker 03:
That finding was based on numerous legal errors.

[00:00:48] Speaker 03:
For example, the board made two independent errors regarding testing.

[00:00:52] Speaker 03:
First, the board legally erred in finding that the testing the inventors say was done was legally sufficient to show the device worked for its intended purpose.

[00:01:03] Speaker 03:
Here, the inventors say they did one specific kind of testing, and that was to take a bench top model, feed the rapid exchange catheter through that model, deliver a stent or balloon, and retrieve the device.

[00:01:15] Speaker 03:
Such testing is insufficient to show that the rapid exchange catheter worked for the intended purpose that the board found, which was to improve or increase backup support.

[00:01:26] Speaker 03:
You can see at the board's opinion on 53 and 55 that the board specifically used the words improved and increased to describe the purpose of better backup support for the delivery.

[00:01:39] Speaker 00:
Counsel, that language isn't in the claims.

[00:01:44] Speaker 00:
Claim 25, for example, is to guide extension catheter for use with a guide catheter.

[00:01:51] Speaker 00:
That is the purpose, to be a guide extension catheter.

[00:01:56] Speaker 00:
Isn't that sufficient?

[00:01:58] Speaker 00:
If you have a chemical compound claimed by its structure, you have to have a purpose.

[00:02:04] Speaker 00:
And so you have to show whether it's an antibiotic, a tranquilizer, or whatever.

[00:02:10] Speaker 00:
But with this claim, the claim itself

[00:02:13] Speaker 00:
indicates what the purpose is.

[00:02:15] Speaker 00:
Why is more necessary?

[00:02:17] Speaker 03:
More is necessary, Your Honor.

[00:02:18] Speaker 03:
The purpose the board found of improving or increasing backup support is not challenged on appeal by Teleflex or Medtronic.

[00:02:26] Speaker 03:
We agree with the board that that was at least one of the intended purposes of the device, and the board explained that that was to increase backup support as compared to a guide catheter alone.

[00:02:37] Speaker 03:
The board specifically uses that language at appendix

[00:02:41] Speaker 03:
44, Your Honor.

[00:02:44] Speaker 03:
And so here, there is no comparative testing to say that that purpose, which everyone agrees is a purpose, could actually show the device work.

[00:02:53] Speaker 00:
What do you mean comparative testing?

[00:02:55] Speaker 00:
This isn't an obviousness question.

[00:02:58] Speaker 00:
This is a question of conception and a reduction to practice of a device defined by the claim language

[00:03:10] Speaker 00:
a guide extension catheter.

[00:03:15] Speaker 03:
We may not need comparative tests.

[00:03:16] Speaker 00:
If it works for that purpose, that's sufficient.

[00:03:19] Speaker 03:
We may not need comparative testing if the board had found a different intended purpose, but the board didn't.

[00:03:25] Speaker 03:
They specifically found the intended purpose, which is not challenged on appeal, of increasing backup support as compared to a guide catheter alone.

[00:03:33] Speaker 03:
And we know what that testing would look like because Teleflex had proved to be good record keepers.

[00:03:38] Speaker 03:
They did that specific type of testing for the non-inventive

[00:03:42] Speaker 03:
and non-patented over-the-wire Guideliner device.

[00:03:46] Speaker 03:
We have the notebook of the engineer, Engineer Kaputzman, who specifically... Is this purpose captured in the claim?

[00:03:55] Speaker 03:
I don't have a claim citation for you that uses the exact language that the board cited, but the board's purpose that they found, again, is not challenged on appeal.

[00:04:04] Speaker 03:
We accept that purpose.

[00:04:05] Speaker 04:
It's irrelevant whether anybody's challenging it on appeal.

[00:04:09] Speaker 04:
That's irrelevant.

[00:04:11] Speaker 04:
We have to look at, and this case is all about, whether or not these claims, there was conception for them, there was diligence, there was a reduction of practice.

[00:04:24] Speaker 04:
testing to know it works for its intended purpose, it seems to me the intended purpose is grounded in the claim language, right?

[00:04:30] Speaker 03:
So I agree with you.

[00:04:31] Speaker 03:
The intended purpose is grounded in the claim language.

[00:04:33] Speaker 03:
And on that point, Your Honor, I would direct this court's attention to Demetronic's other argument regarding toughening chronic occlusions.

[00:04:42] Speaker 03:
That language is

[00:04:43] Speaker 03:
throughout the claim language, in the background, in the specification, the board specifically refused to find that the treatment of tougher chronic occlusions was an intended purpose of the device here.

[00:04:56] Speaker 03:
We think it is very clear in reading the patent and leading the claims that it was an intended purpose.

[00:05:01] Speaker 03:
And on that point, there was simply no testing, no inventor declarations, no corroboration that anyone tested the device to see if it worked for the intended purpose of

[00:05:11] Speaker 03:
treating tougher chronic occlusions.

[00:05:14] Speaker 00:
And in fact, the inventors... Which also isn't in the claim either.

[00:05:18] Speaker 00:
I'm sorry, Your Honor?

[00:05:19] Speaker 00:
Which also isn't in the claims either.

[00:05:22] Speaker 03:
The treatment of tougher chronic occlusions?

[00:05:24] Speaker 00:
Right.

[00:05:24] Speaker 03:
Well, there are references in the background of the patent at Appendix 394.

[00:05:29] Speaker 04:
But those are all things that this device can be used for.

[00:05:32] Speaker 04:
But what the device has to establish, what conception and diligence reduction of practice has to be established for is what is claimed.

[00:05:41] Speaker 04:
And so yes, the background has, in many patents, lots and lots of lofty goals for how a device may or may not be used.

[00:05:49] Speaker 04:
But we have to analyze the conception, diligence, and reduction of practice in the claim language, grounded in the claim.

[00:05:56] Speaker 03:
Well, even if you disagree with me on the intended purpose of tougher chronic occlusions, I would say that even the inventors... When you say whether I disagree with you on the intended purpose, the intended purpose has got to be grounded in the claim language, right?

[00:06:10] Speaker 04:
Because, look, we both know that patents can disclose many different inventions, not just one, but it's what this particular claim is directed to.

[00:06:17] Speaker 03:
Understood, Your Honor.

[00:06:19] Speaker 03:
Here the inventors say they tested the device for the purpose of seeing if the rapid exchange catheter could deliver a cardiology device such as a stent or balloon along the rail segment and retrieve the device.

[00:06:34] Speaker 03:
They say they did that testing in a benchtop model.

[00:06:38] Speaker 03:
There is no sufficient independent corroboration in the record to even say that testing, that benchtop model testing, was done before the critical date.

[00:06:48] Speaker 03:
And that last part is really key here.

[00:06:50] Speaker 03:
Medtronic is not saying that reduction to practice never occurred.

[00:06:54] Speaker 03:
The question is whether Teleflex has independent corroboration that occurred before the critical date of September 23rd, and that corroboration is just not there.

[00:07:04] Speaker 02:
Does Teleflex argue that the

[00:07:08] Speaker 02:
purpose is limited to the claim language and that they don't have to show backup support?

[00:07:17] Speaker 02:
Because Teleflex argued that they don't have to show backup support.

[00:07:23] Speaker 03:
Teleflex argues that no testing would be required.

[00:07:28] Speaker 02:
But that's because, according to them, a simple device in the prior art shows that it would achieve that purpose.

[00:07:34] Speaker 02:
If I understand their brief correctly, they don't argue

[00:07:38] Speaker 02:
that you don't look to the specification to determine the purpose.

[00:07:42] Speaker 03:
I agree, Your Honor.

[00:07:43] Speaker 03:
Teleflex says no testing would have been required.

[00:07:45] Speaker 03:
I'll note that in the board's opinion at footnote 22, the board specifically said, we're not going to address that argument that no testing would be required.

[00:07:57] Speaker 03:
What the board said is that the testing the inventors say was done was sufficient to show that it worked for its intended purpose.

[00:08:03] Speaker 03:
And on that point, on the testing point, we say there's no independent corroboration in the record to even say that benchtop testing was done.

[00:08:11] Speaker 03:
The board cited four sources as purported corroboration for the testing the inventors say was done, but if you actually look at what they cite, it doesn't provide that corroboration.

[00:08:24] Speaker 03:
The board first cites the inventor's testimony itself.

[00:08:27] Speaker 03:
That is the testimony that needs corroboration, and this court has been clear in Medi-Chem and other cases that

[00:08:34] Speaker 03:
Two inventors cannot corroborate each other.

[00:08:36] Speaker 03:
The second thing the board cites is a photograph.

[00:08:39] Speaker 03:
The photograph is of a separate, over-the-wire device.

[00:08:42] Speaker 03:
It happens to have the same name, but it's an over-the-wire device that's not patented.

[00:08:47] Speaker 00:
These are all fact findings that are subject to a substantial evidence difference.

[00:08:54] Speaker 00:
But let me ask you, which is the weaker ground of decision of the board in your view?

[00:09:02] Speaker 00:
Conception plus diligence to a constructive reduction to practice or actual reduction to practice?

[00:09:10] Speaker 03:
I think the board erred on both, Your Honor.

[00:09:12] Speaker 03:
And I think both findings by the board on actual reduction to practice, what we're talking about here, the testing and the intended purpose, and on the diligence side are both underlined by legal errors.

[00:09:25] Speaker 02:
Could you address the diligence issue?

[00:09:27] Speaker 03:
Yes, I can address diligence, Your Honor.

[00:09:29] Speaker 03:
On diligence,

[00:09:32] Speaker 03:
Pelliflex was required to prove that it was engaged in reasonably continuous work throughout the entire critical period.

[00:09:40] Speaker 03:
That period is from September 23rd to May 3rd.

[00:09:43] Speaker 03:
It's approximately seven and a half months.

[00:09:45] Speaker 03:
Pelliflex did not need to work on the invention every day, but it needed to work on the project at regular intervals.

[00:09:52] Speaker 03:
It did not do so.

[00:09:54] Speaker 03:
Out of that seven and a half month period, there are two long gaps totaling nearly four months with no documented diligence at all.

[00:10:02] Speaker 03:
The first gap is nearly a three month period from September 23rd to December 19th.

[00:10:08] Speaker 03:
And the second gap is the entire month of February in 2006.

[00:10:12] Speaker 03:
Together, that's nearly four months, which is over half the diligence period.

[00:10:18] Speaker 03:
Those gaps should have defeated a finding of diligence.

[00:10:21] Speaker 03:
This court has found no diligence in cases with even shorter delays.

[00:10:25] Speaker 03:
or gaps in what we see here.

[00:10:27] Speaker 03:
I would direct Your Honor's attention to Inray Manufacturing Corporation.

[00:10:32] Speaker 03:
There, there was a four-month diligence period, and the court concluded, quote, that an unexplained gap of just over two months defeated diligence.

[00:10:41] Speaker 03:
And in Gold verse Shallow, there was a five-month diligence period, and the court held that a lapse of activity of nearly two months defeated a finding of diligence.

[00:10:51] Speaker 03:
The board erred by excusing Teleflex's delays.

[00:10:55] Speaker 03:
It said the delays were okay because the over-the-wire device came first because it was easier to commercialize.

[00:11:02] Speaker 03:
Well, the reality is that Teleflex planned for regulatory submissions of the rapid exchange catheter, but it didn't perform any work.

[00:11:12] Speaker 03:
in furtherance of those plans.

[00:11:14] Speaker 03:
Instead, what we see in the documents that we have is Teleflex saying, we're going to plan for the rapid exchange device in early 2006.

[00:11:21] Speaker 03:
And then it pushes it back to mid-2006.

[00:11:24] Speaker 03:
And then we have a document that says, oh, never mind, it's not planned for 2006 at all.

[00:11:30] Speaker 03:
And of course, Teleflex was free to prioritize the over-the-wire device or other products during the diligence period as a business decision, but it ran the risk of losing its priority to an independent inventor.

[00:11:45] Speaker 03:
And that's exactly what happened in Griffin.

[00:11:48] Speaker 03:
The board's decision on diligence is underlined by those two errors.

[00:11:53] Speaker 03:
And we would ask that the board, that this court, reverse the findings of diligence.

[00:12:00] Speaker 03:
I'd be happy to use the remainder of my time for rebuttal, Your Honors.

[00:12:04] Speaker 03:
Mr. Vandenberg?

[00:12:06] Speaker 01:
Thank you, Your Honors.

[00:12:07] Speaker 01:
Good morning.

[00:12:08] Speaker 02:
Mr. Vandenberg, on page 48 of your brief, you say, quote, the purpose of the invention was to provide increased backup support.

[00:12:17] Speaker 02:
You agree that that's the purpose of the invention?

[00:12:21] Speaker 01:
Yes, Your Honor.

[00:12:21] Speaker 01:
Now, as has been pointed out today, that particular limitation is not in the claims, which is relevant to the analysis.

[00:12:31] Speaker 01:
Where do you say in your brief that the fact that it's not in the claims is relevant to the analysis?

[00:12:35] Speaker 01:
I don't believe we did, Your Honor, because we have no problem with the issue of backup support.

[00:12:43] Speaker 01:
And it's for the reason that Your Honor said

[00:12:47] Speaker 01:
which is the law is clear.

[00:12:50] Speaker 01:
You don't need to do testing to prove that the invention will do things that are already known to occur with structures like this.

[00:13:01] Speaker 02:
But your problem there is that at A57, the board specifically states that it's not deciding that question.

[00:13:09] Speaker 02:
So you're making an argument to support the board's decision on a ground that they didn't reach.

[00:13:14] Speaker 01:
That is incorrect, Your Honor.

[00:13:16] Speaker 01:
What's incorrect about it?

[00:13:17] Speaker 01:
They're making a bait and switch here.

[00:13:19] Speaker 01:
The board found that they rejected the idea that there was no testing required whatsoever.

[00:13:26] Speaker 01:
But in the course of doing so, they explained what testing was required and in doing that, rejected the idea that you needed to test for the presence of increased backup support.

[00:13:42] Speaker 01:
So it's on pages, if you go on to pages 58 and 59 of the board's opinion, that's where they discuss what testing needs to be performed.

[00:13:52] Speaker 01:
And they agree with both the inventor and with our expert, who independently testified what testing would be required.

[00:14:01] Speaker 01:
They cite at the sentence that bridges pages 58 and 59, they cite exhibit 2123, which is the Keith

[00:14:11] Speaker 01:
declaration, our expert, pages 21 through 22.

[00:14:16] Speaker 01:
And that's where he states, you don't need to test backup support because relative to that feature, the invention operates just like the known mother and child invention.

[00:14:30] Speaker 01:
So you agree that some testing was required there.

[00:14:33] Speaker 01:
The board found that some testing was required.

[00:14:37] Speaker 02:
Our position was that no testing whatsoever was required.

[00:14:40] Speaker 02:
Your experts testified in sort of a very conclusory and unclear way that some testing was conducted.

[00:14:47] Speaker 02:
But I don't see any corroboration for that testing, which you admit was required.

[00:14:53] Speaker 01:
So what Mr. Keith testified, and I take issue with it being conclusory, he explained in detail why you would need to test certain

[00:15:02] Speaker 02:
What about the corroboration?

[00:15:03] Speaker 02:
I don't see any.

[00:15:04] Speaker 02:
What's the corroboration?

[00:15:05] Speaker 01:
Relative to corroboration, the key issue there is this court has repeatedly recognized you don't need direct evidence to corroborate the invention.

[00:15:16] Speaker 01:
You just need enough even circumstantial evidence.

[00:15:19] Speaker 02:
Wait, don't interrupt me, please.

[00:15:21] Speaker 02:
I'm allowed to interrupt you.

[00:15:23] Speaker 02:
You are not allowed to interrupt me.

[00:15:25] Speaker 02:
What's the corroboration for the testing that your experts said occurred?

[00:15:31] Speaker 01:
First of all,

[00:15:32] Speaker 01:
we have the fact that in the April to July timeframe, we had two sets of prototypes that were built for the purpose of testing.

[00:15:41] Speaker 01:
This court has acknowledged that merely ordering prototypes inferentially supports the idea that testing is done.

[00:15:51] Speaker 01:
The other thing we have, and it's very important, there are, for example, the Laurel Fairchild case relies on the fact that

[00:16:00] Speaker 01:
materials were purchased.

[00:16:03] Speaker 02:
If materials were purchased, it supports assembly.

[00:16:06] Speaker 02:
I don't see the cases as saying the purchase of a component shows that testing occurred.

[00:16:12] Speaker 01:
But the same inference you draw for why it's relevant to assembly is also relevant to testing.

[00:16:18] Speaker 01:
You buy parts to build a device.

[00:16:20] Speaker 02:
Our cases didn't make that.

[00:16:21] Speaker 02:
Don't interrupt me please.

[00:16:25] Speaker 02:
Our cases don't say that purchasing material shows that testing was done.

[00:16:29] Speaker 01:
I believe if you read those cases, they are talking about both of those things together.

[00:16:34] Speaker 01:
In addition though, and let me again talk about other evidence, we have the July 2005 PowerPoint that shows an over the wire guidelines inside a test apparatus with a balloon catheter being delivered in it.

[00:16:51] Speaker 02:
So how does testing of another device, which is not the invention, show that the invention here was tested?

[00:16:58] Speaker 01:
because again, the board is allowed to draw inferences from circumstantial evidence.

[00:17:05] Speaker 01:
You've got overlapping timing at the exact same time that we know from that PowerPoint that they are testing the over-the-wire version, and the inventor's testimony is that we were doing both concurrently at this point.

[00:17:20] Speaker 01:
So at the same time that you're testing the over-the-wire, you're also ordering

[00:17:26] Speaker 01:
20, not just one component, but 20 components in April, 20 components again in July.

[00:17:35] Speaker 01:
It is a completely reasonable inference that you don't purchase that many sets of components

[00:17:43] Speaker 01:
certainly to look at them apart, but even to assemble them.

[00:17:47] Speaker 01:
It's just two parts that need to come together and be assembled.

[00:17:50] Speaker 01:
It's reasonable that you don't need 20 of them just to look at it.

[00:17:54] Speaker 01:
That's the corroboration?

[00:17:56] Speaker 01:
Yes, Your Honor.

[00:17:57] Speaker 01:
It is corroboration.

[00:17:59] Speaker 01:
In addition, we also have the testimony from Ms.

[00:18:02] Speaker 01:
Schmalz, who testified that, first of all, she really said at least two things that are important to that corroboration on testing.

[00:18:12] Speaker 01:
One is that

[00:18:14] Speaker 01:
there was this August 24th products requirements document that she testified as her role as head of regulatory is a document we don't create at Vascular Solutions until there has been sufficient testing to know that the concept of the product is going to work.

[00:18:36] Speaker 01:
And so she testified the fact that that document exists corroborates

[00:18:43] Speaker 01:
that there was testing performed.

[00:18:45] Speaker 01:
The other thing that she testified is that she had a specific recollection prior to August 24, 2005 that prototypes of the Rapid Exchange Guideline had been tested and worked.

[00:19:02] Speaker 02:
Is that it?

[00:19:03] Speaker 01:
That's it on that issue, Your Honor.

[00:19:06] Speaker 01:
So could you turn to diligence?

[00:19:09] Speaker 01:
Yes.

[00:19:09] Speaker 01:
Let me talk about diligence just briefly.

[00:19:11] Speaker 01:
And of course, my first point on diligence is that it is an alternative basis to support the board's decision.

[00:19:20] Speaker 01:
If this board concludes there was actual reduction to practice prior to September 23rd, you don't need to reach the issue of diligence.

[00:19:27] Speaker 01:
Okay.

[00:19:27] Speaker 02:
So here you have two periods of time, February, where you agree nothing happened and the September to December period where

[00:19:36] Speaker 02:
it appears that the only thing that happened was one engineering drawing.

[00:19:44] Speaker 02:
Those two periods constitute a majority of the relevant period, right?

[00:19:49] Speaker 01:
First of all, they are not the majority of the period, but I also would disagree with you.

[00:19:56] Speaker 01:
How are they not the majority of the period?

[00:19:59] Speaker 01:
The period runs from September to May.

[00:20:02] Speaker 02:
Yeah.

[00:20:03] Speaker 01:
So I believe we're talking about a couple of roughly one month periods.

[00:20:08] Speaker 02:
No, it's September 20 or September 23 to December 19, something like that.

[00:20:17] Speaker 01:
There is a document from before that time that shows, again, another example of the prototype drawings.

[00:20:27] Speaker 01:
But I want to make a more fundamental point here.

[00:20:31] Speaker 01:
which is that idea that, well, if we only have something dated this date and another piece of corroboration dated this date, that there's no evidence that anything happened in between.

[00:20:43] Speaker 02:
Well, sure, you could have a document that happens after the period that describes work that was done during the period.

[00:20:51] Speaker 02:
Obviously, that's true, but the problem is there aren't any such documents here.

[00:20:55] Speaker 01:
But, for example, take the drawing from, I believe, November of yet another

[00:21:01] Speaker 01:
prototype sent to spectralytics to be made.

[00:21:05] Speaker 01:
That doesn't reflect work just on the date of that drawing.

[00:21:08] Speaker 01:
That document had to be drawn.

[00:21:11] Speaker 01:
That takes some time.

[00:21:13] Speaker 01:
It's sent to spectralytics.

[00:21:15] Speaker 01:
They then need to build a prototype.

[00:21:17] Speaker 02:
There's no testimony that they worked on the drawing earlier.

[00:21:21] Speaker 01:
Your Honor, we're talking about activities

[00:21:25] Speaker 01:
that happened 15 years ago for somebody to say today exactly what happened is unrealistic.

[00:21:30] Speaker 02:
You still have to have corroboration.

[00:21:32] Speaker 02:
The problem is that nothing happened here for long periods of time as far as the documentary record is concerned.

[00:21:41] Speaker 01:
But again, diligence like actual reduction to practice doesn't need to be proven with corroborating evidence.

[00:21:52] Speaker 01:
We just need

[00:21:53] Speaker 01:
enough corroborating evidence to show that the inventor's testimony is credible.

[00:22:01] Speaker 01:
The inventors testified that the work that happened throughout that period was continuous.

[00:22:07] Speaker 01:
It was never set aside.

[00:22:09] Speaker 01:
It was never abandoned.

[00:22:11] Speaker 01:
And even the two non-inventor witnesses, Urb and Schmaltz,

[00:22:17] Speaker 01:
both corroborate that.

[00:22:18] Speaker 01:
They both say this was an important project that work continued throughout.

[00:22:22] Speaker 01:
So that's the evidence of diligence.

[00:22:25] Speaker 01:
The question then becomes corroboration.

[00:22:28] Speaker 01:
Obviously, for the documents, they are spaced out in time, but the board went through them in detail and explained why those corroborate the inventor's testimony

[00:22:42] Speaker 01:
Not that there's continuous work, but that there was reasonably continuous work, that the product was never abandoned, it was never put on the shelf.

[00:22:56] Speaker 01:
Your Honor, I do want to, if I could, go back briefly to... How do you just stick with the corroboration for diligence for a second?

[00:23:06] Speaker 04:
What is the precise evidence

[00:23:09] Speaker 04:
that is corroborating the inventor's testimony of diligence, say between September 23rd and the end of November.

[00:23:17] Speaker 04:
What are the exact pieces of evidence that you rely upon?

[00:23:21] Speaker 01:
Yes, your honor.

[00:23:24] Speaker 01:
So for example, the board goes through this month by month and they say in 2005, I'm on page 64 of the appendix.

[00:23:35] Speaker 01:
October, Mr. Root refers to a business update

[00:23:38] Speaker 01:
presented to the board where they're talking about presenting the guidelines to physician advisors.

[00:23:47] Speaker 01:
He provided an update on their intentions to file and talks about the work done relative to the patent application.

[00:23:54] Speaker 04:
That's all testimony of the inventor.

[00:23:57] Speaker 04:
I understand that your argument is that the inventor testimony

[00:24:01] Speaker 04:
establishes the diligence, but you have to have corroboration of that testimony.

[00:24:05] Speaker 04:
So where is the corroboration?

[00:24:06] Speaker 01:
So in that paragraph, for example, they're citing a document.

[00:24:10] Speaker 01:
Exhibit 2041.

[00:24:11] Speaker 01:
Then in... Do you have that document?

[00:24:15] Speaker 01:
Yes, we do, Your Honor.

[00:24:16] Speaker 04:
Where is it?

[00:24:18] Speaker 01:
Oh, boy.

[00:24:20] Speaker 01:
I might have difficulty identifying that exact document on the fly.

[00:24:27] Speaker 01:
I did annotate my notebook fairly well.

[00:24:32] Speaker 02:
This is the business update presentation in October, is that what you're talking about?

[00:24:39] Speaker 02:
Correct, correct.

[00:24:41] Speaker 02:
That's exhibit 2041.

[00:24:42] Speaker 01:
Okay.

[00:24:43] Speaker 01:
And it's a... Yeah, it's exhibit 2041.

[00:24:46] Speaker 02:
It's a nice, late exhibit.

[00:24:47] Speaker 02:
It's at 9889.

[00:24:47] Speaker 02:
Thank you, Your Honor.

[00:24:50] Speaker 02:
Then, for November... But it doesn't say, this document doesn't say anything about work during the October period.

[00:24:59] Speaker 02:
what he's saying is that this is important.

[00:25:01] Speaker 02:
But Plants doesn't say what had been done during this period.

[00:25:07] Speaker 00:
The board's opinion says Mr. Root declares this update included extremely favorable reviews of the guideline from physician advisors.

[00:25:19] Speaker 02:
Never tells you when those reviews occurred or whether they occurred during this period.

[00:25:26] Speaker 01:
Your Honor, you would expect they'd be

[00:25:30] Speaker 01:
happened shortly before that.

[00:25:31] Speaker 01:
And in fact, if you look at the Schmal's declaration, she talks about the same document.

[00:25:37] Speaker 01:
She does say that what that document shows is that the work perhaps was done earlier.

[00:25:43] Speaker 01:
and corroborates her recollection that reduction of practice.

[00:25:47] Speaker 04:
Well, whether you're right or wrong, that this document corroborates.

[00:25:49] Speaker 04:
What other?

[00:25:50] Speaker 04:
I just wanted to make sure you have an opportunity to put on the oral argument right here.

[00:25:54] Speaker 04:
All of the evidence that you believe corroborates the inventor's testimony, which establishes diligence.

[00:26:00] Speaker 01:
Yes, Your Honor.

[00:26:00] Speaker 04:
What else do you have?

[00:26:01] Speaker 01:
Moving on to November, the board cites the document I mentioned before, which is another one of the prototype

[00:26:11] Speaker 01:
proximal pieces supplied to Spectrolytics, citing exhibit 2115.

[00:26:17] Speaker 01:
That's the one that... They agree that that was activity during the period.

[00:26:21] Speaker 02:
That's the one thing in this period.

[00:26:23] Speaker 01:
Yes.

[00:26:23] Speaker 01:
But again, my point there is that it's reasonable to infer that that document isn't one days of work, that that reflects work that happened before it and work that happened after it.

[00:26:37] Speaker 01:
For December,

[00:26:39] Speaker 01:
They talk about... The document is dated when?

[00:26:44] Speaker 01:
I don't have the exact date.

[00:26:46] Speaker 01:
November 11th.

[00:26:47] Speaker 01:
Thank you.

[00:26:50] Speaker 04:
So right in the middle of the period for which there is no alleged diligence, there is inventor testimony of diligence and a document that is... What is the nature of that document?

[00:27:02] Speaker 01:
It is another drawing of the proximal portion of the device, the cut down hypotube as we call it.

[00:27:09] Speaker 01:
which was sent out to Spectrolytics to cut, finish, and then provide back to VSI so that they could mate it up with that distal tubular portion for testing.

[00:27:26] Speaker 04:
Okay, now can you explain that in English?

[00:27:28] Speaker 04:
Was it, you know, it's a schematic?

[00:27:30] Speaker 04:
Like it's a drawing of the thing that people are going to use to make it?

[00:27:34] Speaker 01:
It is an engineering drawing used to make the part.

[00:27:37] Speaker 01:
If you look at it, you will see it is essentially identical to what is shown in figures 10 through 12 of the Pattinson suit.

[00:27:46] Speaker 01:
So it includes a top view of a cut down hypotube saying exactly what the dimensions should be, how they're to form it.

[00:27:57] Speaker 04:
And then is the idea it was then turned over to someone for production or something?

[00:28:02] Speaker 01:
It would be turned over to mate to a distal tubular portion for testing.

[00:28:10] Speaker 04:
Okay, is there anything else?

[00:28:10] Speaker 04:
Because you're out of time.

[00:28:11] Speaker 01:
Your Honor, I just point the Court's attention to pages 64 to 66.

[00:28:15] Speaker 01:
I'll also reiterate that the Board's finding on actual reduction to practice here was full and complete and fulsome, and there's no reason to even reach the diligence issue if you agree with the Board on actual reduction to practice.

[00:28:31] Speaker 04:
Okay, thank you.

[00:28:34] Speaker 03:
Thank you, Your Honours.

[00:28:36] Speaker 03:
Judge Laurie, if I could go back to your earlier question about the intended purpose in the claim language, I would direct Your Honour to the case Berry v. Medtronic, which the Court discusses finding the intended purpose within the background and specification of the device, and I believe that is what the Board did here.

[00:28:52] Speaker 03:
On the issue of corroboration, both for actual and constructive reduction to practice, I would say that everything that Mr. Vandenberg just pointed to is vague and speculative and even taken together or individually.

[00:29:06] Speaker 03:
November 11th document is speculative?

[00:29:09] Speaker 03:
I'm sorry, Your Honor, which document did you refer to?

[00:29:11] Speaker 03:
November 11th, 2115.

[00:29:14] Speaker 03:
The November 1st CAD drawing that we were just discussing in terms of diligence.

[00:29:19] Speaker 03:
That CAD drawing is a computer aided design.

[00:29:22] Speaker 03:
It is marked preliminary version 1.

[00:29:24] Speaker 03:
There is no testimony as to when it was worked on and no any indication that a later version was ever drawn.

[00:29:31] Speaker 03:
But even if you take that document at face value, that's November 1st.

[00:29:35] Speaker 03:
There would still be a gap from November 1st through the end of December, which is another... I'm confused.

[00:29:41] Speaker 04:
The end of December.

[00:29:42] Speaker 04:
Because in the board's opinion, it talks about two periods particularly alleged to represent a lack of diligence.

[00:29:47] Speaker 04:
It says the first... I'm on page 68 of their opinion so that you can keep track.

[00:29:51] Speaker 04:
It says the first was from September 23rd of 2005 to the end of November.

[00:29:56] Speaker 03:
And I would say, Your Honor, that that diligence actually extends to the end of December because there are no documents within that time period to support diligence during that time.

[00:30:05] Speaker 04:
Well, so are you saying that the board erred?

[00:30:08] Speaker 04:
Did another one of its many errors is that it failed to look at the right time period?

[00:30:12] Speaker 03:
I would say the gap is even longer than what the board said, Your Honor.

[00:30:15] Speaker 03:
Yes.

[00:30:16] Speaker 03:
And on the point that Mr. Vandenberg was talking about, about assuming work in between documents, this court, in the DeMacco case, which we discussed in our reply week, took on that exact argument.

[00:30:28] Speaker 03:
It said you can't infer diligence in between periods.

[00:30:31] Speaker 03:
Diligence has to be proven.

[00:30:33] Speaker 03:
And the court there specifically talked about not generally relying on the rule of reason, but proving diligence.

[00:30:41] Speaker 04:
But that was in a scenario in which you had no actual evidence of diligence.

[00:30:49] Speaker 04:
Here you have the inventor testimony, and we're looking only at corroborating evidence.

[00:30:54] Speaker 04:
So there's a difference between that case and this case, because this case has inventor testimony claiming continuous work.

[00:31:01] Speaker 03:
Well, the inventor testimony, I would say, even on its face is very conclusory and just merely restates the legal principle that we work diligently on this device.

[00:31:09] Speaker 03:
There's no specific even within the inventor testimony as to what they were doing and when.

[00:31:14] Speaker 03:
And in my remaining time, if I can just point briefly to the corroboration that he pointed to on

[00:31:19] Speaker 03:
actual reduction to practice.

[00:31:21] Speaker 03:
He pointed to the testimony of an expert, Heath.

[00:31:23] Speaker 03:
He was an hired expert for the purposes of these proceedings who had no first-hand knowledge and could not possibly corroborate testing.

[00:31:30] Speaker 03:
And he pointed to the over-the-wire photograph.

[00:31:33] Speaker 03:
Again, vague and speculative to look at that photograph and say, okay, we're going to then assume that the rapid exchange device was also tested and it was tested before the critical date and it worked for its intended purpose.

[00:31:45] Speaker 03:
And the third thing I heard him point to is a declaration from Ms.

[00:31:49] Speaker 03:
Schmaltz.

[00:31:50] Speaker 03:
Ms.

[00:31:51] Speaker 03:
Schmaltz's entire declaration is seeking to say

[00:31:54] Speaker 03:
Example documents would not exist unless the device worked for its intended purpose.

[00:32:00] Speaker 03:
She was in the regulatory department.

[00:32:01] Speaker 03:
She had no firsthand knowledge of testing.

[00:32:03] Speaker 03:
She would have to have relied on other people.

[00:32:06] Speaker 03:
But even then, the board found the documents that she's talking about somewhat less probative in finding actual reductive practice and with good reason.

[00:32:15] Speaker 03:
The product requirements document is a prime example.

[00:32:18] Speaker 03:
The 2005 version of that document, which is in the record at 9759, is completely blank as to product specification and testing methods.

[00:32:28] Speaker 03:
If you look at that same document in the 2009 version... Okay, Ms.

[00:32:31] Speaker 04:
Pescahal, I let you run over quite a bit.

[00:32:32] Speaker 04:
We're going to call it at this point.

[00:32:34] Speaker 04:
I thank both counsels.

[00:32:35] Speaker 04:
This case is taken under submission.