[00:00:00] Speaker 01:
Okay, the next argued case this morning, December 21, 2063, INSEP-DLLC against Paladin Life Sciences Incorporated.

[00:00:11] Speaker 01:
Mr. Grappott.

[00:00:14] Speaker 03:
Good morning.

[00:00:14] Speaker 03:
Thank you, Your Honors.

[00:00:15] Speaker 03:
May it please the Court.

[00:00:18] Speaker 03:
INSEP respectfully submits that the Board committed multiple errors in this case in its analysis of the 723 and the 913 patents and that they require reversal and remand.

[00:00:27] Speaker 03:
I want to focus on

[00:00:29] Speaker 03:
The two main issues, the board's decision on anticipation with respect to various claims of the 723 patent, in particular claim one, and then the board's decision on obviousness with respect to some other claims in the 723 patent and then all the claims of the 913 patent.

[00:00:46] Speaker 03:
So starting with anticipation, the board's decision here was based on an improper legal framework for assessing anticipation by the Wallace reference.

[00:00:58] Speaker 03:
As we explained in our brief, the board, you know, what they resorted to is picking and choosing, selecting different sections of the Wallace reference rather than applying the framework of looking for a disclosure of not only just the limitations in the reference, but all the limitations arranged in the same way as claimed by, in this case, claim one of the 723 patent.

[00:01:19] Speaker 03:
And under that analysis, the Wallace reference, there's no substantial evidence that would show the Wallace reference discloses

[00:01:26] Speaker 03:
the invention of claim one as arranged in that claim.

[00:01:29] Speaker 03:
The Wallace references, as we explain, it discloses millions, potentially billions of potential compositions for wide ranging applications, tissue augmentation, sealants, drug delivery systems, wide ranging applications.

[00:01:43] Speaker 03:
And there's one sentence that refers to a potential application as a large space filling device.

[00:01:50] Speaker 03:
But there's no identification of what composition would be used for that device, let alone the properties of that composition or how they'd be arranged in the same manner as in claim one.

[00:02:01] Speaker 01:
And everyone is against it.

[00:02:03] Speaker 01:
Council, to move things along, let's assume, for the sake of this morning's argument, that there is a strong point to be made that the technical criteria of anticipation may not have been met.

[00:02:19] Speaker 01:
How about obviousness?

[00:02:22] Speaker 03:
Yes, Your Honor.

[00:02:22] Speaker 03:
On obviousness, so there's claim 16 would be the dependent claim of the 723 patent that is just obvious based on Wallace.

[00:02:31] Speaker 03:
And then all of the claims of the 913 patent are based on obviousness.

[00:02:36] Speaker 03:
And that anticipation analysis absolutely infected

[00:02:40] Speaker 03:
The anticipation analysis infected the obviousness analysis because the board, reading the decision, was viewing Wallace as anticipating and did not explain which limitations would have been missing from Wallace, how the gap filling would have been there.

[00:02:55] Speaker 03:
So it was a very, on the gram factor analysis, the scope and content of the prior art, as we explained, we believe that was skewed, if you will, by the improper anticipation analysis.

[00:03:06] Speaker 03:
So that's on just the reading of Wallace's scope and content of the prior art.

[00:03:10] Speaker 03:
And Wallace, as we talk about, also talks about how it's not readily degradable, essentially non-degradable.

[00:03:17] Speaker 03:
Wallace isn't disclosing this key limitation of removable by biodegradation.

[00:03:22] Speaker 03:
What the experts keep talking about and what the board pointed to, what Pallett's expert was referring to and the board pointed to was that Wallace refers to the option of including biodegradable segments or blocks in the composition, but it doesn't describe

[00:03:40] Speaker 03:
a composition that's removable by biodegradation.

[00:03:43] Speaker 03:
It just says there's this option of including some type of segment that's biodegradable.

[00:03:47] Speaker 03:
But there's no disclosure of how that results in removable by biodegradation, your honor.

[00:03:52] Speaker 03:
And then in addition, as we explained, the board made a fundamental error in not considering the evidence of commercial success, the secondary factors of commercial success, which INCEPT presented significant evidence of commercial success.

[00:04:08] Speaker 03:
And what the board found on that issue was that INCEPT had not met its burden of production and never considered that in the context of a proper gram analysis.

[00:04:18] Speaker 03:
The board said INCEPT had not met its burden of production and then stopped the analysis right there.

[00:04:25] Speaker 03:
And in fact, the board never shifted the burden on secondary factors.

[00:04:31] Speaker 03:
from INCEP.

[00:04:32] Speaker 03:
The board even said that it did not reach the issue of Nexus, for example, because INCEP had not met its burden of production and commercial success.

[00:04:40] Speaker 03:
So the board kept the burden.

[00:04:42] Speaker 00:
Can I just ask, can one read the board's decision as saying, we have some real difficulty with some of the details of the submission on commercial success, that it wasn't maybe new patients as opposed to

[00:05:00] Speaker 00:
returning patients, that the use of a one-third rate figure from a British study didn't really seem to be right.

[00:05:08] Speaker 00:
But in any event, the prior art component of the analysis is so very strong.

[00:05:17] Speaker 00:
And the recency of Wallace makes any commercial success here just not a basis for inference of

[00:05:30] Speaker 00:
of non-obviousness because Wallace is what, less than a year or something ahead of the priority date here.

[00:05:39] Speaker 00:
And the fact that there wasn't a commercial product out there in the marketplace based on that prior art doesn't really tell you that when the next art, namely this comes along, that the fact that it is successful means that it wasn't obvious in light of Wallace.

[00:06:01] Speaker 03:
Your honor, respectfully, I don't think you can read the board's decision that way.

[00:06:05] Speaker 03:
The board did not make those findings.

[00:06:07] Speaker 03:
So the board did not do an analysis where it said... But those are legal components, right?

[00:06:13] Speaker 00:
I mean, the relationship in the overall analysis of the prior artifacts and the secondary consideration facts, that goes into what is now a legal hopper.

[00:06:24] Speaker 03:
The legal conclusion on obviousness.

[00:06:26] Speaker 03:
Yes, your honor, absolutely.

[00:06:27] Speaker 03:
The board didn't get there, though.

[00:06:30] Speaker 03:
The board was there.

[00:06:30] Speaker 03:
Well, we can do that.

[00:06:36] Speaker 03:
On obviousness, we do think on anticipation that could be reversed.

[00:06:39] Speaker 03:
On obviousness.

[00:06:41] Speaker 00:
Right.

[00:06:41] Speaker 00:
Anticipation becomes a material if obviousness is accepted.

[00:06:45] Speaker 03:
Yeah.

[00:06:45] Speaker 03:
In our view, Your Honor, the proper course would be remanding that to the board since the board was clear that it didn't reach the issue of commercial success because we hadn't met our

[00:06:58] Speaker 03:
burden of production was what the board found.

[00:06:59] Speaker 03:
And then the board also said it didn't even get to the issue of Nexus, which we certainly believe there's sufficient evidence of Nexus between the space or product and the claims.

[00:07:10] Speaker 03:
But the board never reached that issue.

[00:07:12] Speaker 03:
So we've been viewing this as the proper course would be a remand.

[00:07:17] Speaker 03:
And the board never did reach those conclusions to your earlier question, Your Honor.

[00:07:22] Speaker 03:
The board never

[00:07:24] Speaker 03:
said that the commercial never reached this analysis.

[00:07:27] Speaker 03:
We're weighing the commercial success.

[00:07:28] Speaker 03:
The board just found that INCEPT had not met its burden.

[00:07:31] Speaker 03:
And we maintain that INCEPT produced substantial evidence of commercial success.

[00:07:37] Speaker 03:
This product was approved by the FDA in 2015 and then was immediately met with significant success.

[00:07:45] Speaker 03:
First, AugmentX between 2015 and 2017 showed doubling of sales volume.

[00:07:50] Speaker 03:
Boston Scientific acquired

[00:07:52] Speaker 03:
Augmentics based on this product for $500 million with milestones and it continued to be very successful.

[00:07:58] Speaker 03:
Dr. Shulwater, our expert, looked at the market.

[00:08:01] Speaker 03:
Even though market share is not a requirement, as we talked about in our brief, Dr. Shulwater looked at the market and concluded that there's approximately 55%.

[00:08:11] Speaker 00:
The success didn't occur until 2014.

[00:08:15] Speaker 00:
years or something after or 12 years or something after the priority date.

[00:08:20] Speaker 00:
Why doesn't that tell you that the non market presence after Wallace, which is 2001 and this one's 2003 is just not very significant.

[00:08:34] Speaker 00:
It took your people a dozen years to get into the market.

[00:08:38] Speaker 03:
Well, it took AugmentX a while to get into the market, for sure, and then to do the testing and getting FDA approval.

[00:08:46] Speaker 03:
We do believe, Your Honor, that Wallace issued in 2003, and the fact that no one else was releasing a product like this, setting aside the prior date of the patents.

[00:08:57] Speaker 03:
But the fact that no one else was rushing to market with us after 2003 is a classic example of how it's not obvious.

[00:09:05] Speaker 03:
If it would have been so obvious based on Wallace,

[00:09:08] Speaker 03:
so straightforward based on Wallace, why wouldn't someone else have done it?

[00:09:12] Speaker 03:
Why was no one else coming to the market with this product?

[00:09:17] Speaker 03:
And so we do think this is a situation where the commercial success is highly relevant and goes to this question of, well, if it was so obvious, why didn't anybody else do it?

[00:09:28] Speaker 03:
And the commercial success evidence, it was simply not considered

[00:09:32] Speaker 03:
not considered by the board, according to the board's decision, because we did not meet our burden of production, and we believe we clearly did.

[00:09:40] Speaker 03:
On the dependent claims as well, on the question of obviousness, this would be, in particular, claim 16 on the 723 patent and claim six on the 9113 patent.

[00:09:51] Speaker 03:
These dependent claims get into more details of the specific time for the removability by biodegradation, with claim 16 talking about three to 12 months

[00:10:01] Speaker 03:
Claim 6 being less than approximately 90 days.

[00:10:04] Speaker 03:
And this further highlights the board's errors in analyzing Wallace, where Wallace does not disclose these time frames for biodegradation.

[00:10:14] Speaker 03:
And again, all Wallace says is there's an option of including biodegradable segments.

[00:10:19] Speaker 03:
Doesn't provide any more details on that.

[00:10:22] Speaker 03:
And it certainly doesn't talk about removing something by biodegradation within these time frames.

[00:10:27] Speaker 03:
And so on dependent claims 16 and 6,

[00:10:31] Speaker 03:
We submit that these are further instances where the board committed independent errors in its analysis of Wallace.

[00:10:38] Speaker 02:
What about claims two through five?

[00:10:41] Speaker 02:
Are they also?

[00:10:41] Speaker 03:
Two through five, your honor, of the 723?

[00:10:47] Speaker 03:
Yes.

[00:10:50] Speaker 03:
Claims two through five, your honor, that would be on obviousness.

[00:10:57] Speaker 03:
And with claims two through five, those are really

[00:11:01] Speaker 03:
The heirs are one and the same with claim one of the 723, with the misreading Wallace and not considering the secondary factors.

[00:11:09] Speaker 03:
We don't, on those claims, have an independent argument for non-obviousness.

[00:11:15] Speaker 03:
If there are further questions, I'll reserve my time.

[00:11:19] Speaker 01:
We'll save the rest of your time for rebuttal.

[00:11:22] Speaker 01:
Let's hear from the other side.

[00:11:26] Speaker 02:
Mr. Kong, good morning, Your Honors.

[00:11:28] Speaker 02:
May it please the Court.

[00:11:29] Speaker 02:
Substantial evidence supports the Board's findings that a skilled artisan would understand Wallace either alone or in combination with other references to disclose or render obvious all claims of the 723 patent and all claims of the 913 patent.

[00:11:45] Speaker 02:
Substantial evidence also supports the Board's finding that Wallace anticipates certain claims of the 723 patent.

[00:11:51] Speaker 02:
Now, INCEP's appeal implicates the substantial evidence standard, but INCEP's arguments focus on isolated excerpts from Wallace rather than on the totality of the record as a whole.

[00:12:02] Speaker 02:
Now, here the record as a whole includes the four corners of Wallace.

[00:12:06] Speaker 02:
It includes expert testimony provided by our experts regarding the content of Wallace.

[00:12:10] Speaker 02:
And it also includes the board's determination that the credibility of INCEP's experts who testified about the content of Wallace was just not there.

[00:12:18] Speaker 02:
I think the words they used were,

[00:12:20] Speaker 02:
We do not assign persuasive weight to their testimony, and every time in the final written decision the court addresses their testimony, it discredits it.

[00:12:29] Speaker 02:
So when that record is viewed as a whole, as required under the substantial evidence standard, INCEF's arguments fall short of it.

[00:12:37] Speaker 02:
In addition, INCEF's appeal attempts to raise a number of factual issues that were not disputed below, including a new argument that Wallace teaches away from a biodegradable filler

[00:12:48] Speaker 02:
A new argument that Wallace's disclosure of its compositions as a space filler for organ displacement used during radiation therapy somehow does not map to the claims at issue here.

[00:12:59] Speaker 02:
And new arguments regarding dependent claims that were not separately argued below.

[00:13:03] Speaker 02:
Your Honor just pointed out claims two through five.

[00:13:06] Speaker 02:
Those claims were not identified at all in the opening brief.

[00:13:09] Speaker 02:
The only place they come up is in the reply.

[00:13:11] Speaker 02:
And under this court's precedent, if it's not in the opening brief, it doesn't count.

[00:13:15] Speaker 00:
It's not on the seal.

[00:13:16] Speaker 00:
But 6 and 16, respectively, were argued separately below?

[00:13:20] Speaker 02:
6 and 16 had separate arguments regarding that.

[00:13:22] Speaker 00:
So what's your answer to that?

[00:13:26] Speaker 00:
to insect's criticism of the board's treatment of those?

[00:13:31] Speaker 02:
The board relied on the totality of the Wallace reference, which discloses biodegradability in numerous places, including an extensive discussion of the topic in columns, I believe it's 19 and 20.

[00:13:42] Speaker 02:
It credits the testimony of Dr. Dicker, our expert, who testified that one of skill in the art who reads those disclosures, and those disclosures talk about not only biodegradability, but also the rate of biodegradability.

[00:13:56] Speaker 02:
And specifically, they compare collagen to another form of collagen and say that this other form of collagen will biodegrade at a faster rate.

[00:14:04] Speaker 02:
It may be ideal for certain purposes.

[00:14:06] Speaker 02:
So the idea of the time at which something will biodegrade is discussed in Wallace.

[00:14:11] Speaker 02:
And Dr. Dicker testified that want to skill in the art reading that would understand how to tune.

[00:14:16] Speaker 00:
Does Wallace?

[00:14:17] Speaker 00:
ever talk about biodegradation of the entirety of an insert, as opposed to components, which is, I think, what I understood your friend on the other side to research.

[00:14:29] Speaker 02:
So that issue came up in the briefing for the first time, this notion of entirely removable by biodegradation.

[00:14:35] Speaker 02:
So first of all, the word entirely is not in the claim.

[00:14:38] Speaker 02:
It's just removable by biodegradation.

[00:14:40] Speaker 02:
So we're not sure where that argument's coming from.

[00:14:42] Speaker 00:
What is it in the claim that's removable by biodegradation?

[00:14:46] Speaker 02:
The filler.

[00:14:47] Speaker 00:
The filler.

[00:14:48] Speaker 00:
That sounds like the filler.

[00:14:50] Speaker 00:
The whole thing.

[00:14:52] Speaker 02:
The whole thing by biodegradation, correct.

[00:14:54] Speaker 00:
So I thought I was hearing your friend on the other side this morning say Wallace refers to biodegradation but never as to the entirety of the filler.

[00:15:06] Speaker 02:
Right, so removable via biodegradation.

[00:15:09] Speaker 02:
So the body's processes can remove that filler

[00:15:12] Speaker 02:
via biodegradation.

[00:15:13] Speaker 02:
It doesn't say obliterate, reduce it to its atoms.

[00:15:15] Speaker 02:
It just says remove it from its place in the body.

[00:15:18] Speaker 02:
For example, Devon Villiers' space.

[00:15:20] Speaker 02:
Remove it from that space.

[00:15:22] Speaker 02:
So Wallace doesn't say it will entirely remove from the space, but the concept of biodegradation clearly contemplates that it will degrade and the body's processes will remove it from that place and flush it out of the body.

[00:15:36] Speaker 02:
And again, the testimony of Dr. Dicker regarding the timing of biodegradation was credited by the board.

[00:15:42] Speaker 02:
He said that one could tune biodegradation to hit those time points.

[00:15:46] Speaker 02:
And the testimony against that offered by Dr. Winnick, I believe, on the other side, was discredited by the board.

[00:15:53] Speaker 02:
So substantial evidence supports the board's findings regarding both of those claims.

[00:15:57] Speaker 00:
Can you address the commercial success analysis, which was fairly limited

[00:16:04] Speaker 02:
uh... or it's so incepts uh... there's the burden of production that was assigned correctly to people all the cards and i think you know so it's not a district court action i can't discovery from them regarding commercial success they all the cards they produce whatever they want to produce here they produced a single card and i was a sliver of information regarding units shipped units that left the door of insect and went out to the world

[00:16:33] Speaker 02:
The testimony of Ms.

[00:16:34] Speaker 02:
Ray, whose witness testified about this data, said that that's only unit shipped.

[00:16:41] Speaker 02:
And unit shipped includes three things, units sold, samples, which are free, and also replacement parts, which aren't sold.

[00:16:48] Speaker 02:
They're replacements.

[00:16:50] Speaker 02:
Because they relied on units shipped and because Ms.

[00:16:53] Speaker 02:
Ray testified that unit shipped is not unit sold, the board couldn't decipher what to do with the unit shipped information and said that's not, that doesn't meet your burden of production on commercial success because unit shipped doesn't tell us anything about success.

[00:17:08] Speaker 02:
It tells us how many products left the door and that's it.

[00:17:13] Speaker 02:
So the other problem here was that

[00:17:15] Speaker 02:
We heard some testimony about, or some argument about market share in this 55% market share figure that NCEP is throwing around.

[00:17:23] Speaker 02:
Well, there's two problems with that.

[00:17:24] Speaker 02:
The first is that it relies on units shipped.

[00:17:27] Speaker 02:
So not units sold, but units shipped.

[00:17:30] Speaker 02:
That's the numerator of the equation.

[00:17:31] Speaker 02:
The denominator of that equation is a number, it's about 170,000, which they say are the new cases in 2019.

[00:17:41] Speaker 02:
So there were 170,000 new cases of prostate cancer in 2017.

[00:17:45] Speaker 02:
They adjust that number by one third, deciding to the UK study, which Your Honor pointed out.

[00:17:51] Speaker 02:
One thing Your Honor did not point out is that that UK study, it was designed to randomize the about 1,000 patients into one of three treatment groups, one of which was radiation.

[00:18:04] Speaker 02:
So by design, one third of those patients ended up in the radiation treatment group.

[00:18:10] Speaker 02:
Yet NCIP takes that design element of a clinical study and applies it more generally to the entire patient population in the United States and says, oh, well, if it was one third in this one study, it's gotta be one third in the US.

[00:18:22] Speaker 02:
But there's no basis for them to extrapolate that one third figure in that matter.

[00:18:27] Speaker 02:
So both the numerator and the denominator of this 55% market share estimation they provide have serious questions and the board pointed out all of those questions.

[00:18:36] Speaker 02:
And they did so reasonably.

[00:18:38] Speaker 02:
And that's, I'm emphasizing that.

[00:18:40] Speaker 00:
Can you remind me, and your evidence on the topic of commercial success was what?

[00:18:46] Speaker 02:
We didn't produce any evidence.

[00:18:48] Speaker 02:
We don't hold any of those cards.

[00:18:51] Speaker 02:
So, they hold all the cards.

[00:18:53] Speaker 02:
We couldn't seek discovery.

[00:18:54] Speaker 02:
They produced a sliver of evidence that we criticized.

[00:18:57] Speaker 02:
But that's the sum of them.

[00:18:57] Speaker 00:
And you criticized, lawyer criticized or expert criticized?

[00:19:00] Speaker 02:
We had an expert criticize that as well.

[00:19:02] Speaker 02:
It was Dr. McDuff.

[00:19:04] Speaker 02:
So the sum total of commercial success is units shipped without any information in 2018 or 2019 regarding how many of those units were actual sales, how many were samples, how many were replacement parts.

[00:19:16] Speaker 02:
And that's notable here because in 2018, that's when Boston Scientific took over the product.

[00:19:22] Speaker 02:
So did they change the marketing practices?

[00:19:24] Speaker 02:
Did they offer more pre-samples?

[00:19:27] Speaker 00:
What's a replacement part for a product that's designed to biodegrade and disappear after some months?

[00:19:36] Speaker 02:
So if it breaks during shipping, or if a doctor doesn't apply it correctly.

[00:19:40] Speaker 02:
Replacement pre-insertion.

[00:19:42] Speaker 02:
Right.

[00:19:42] Speaker 00:
Replacement pre-insertion.

[00:19:45] Speaker 02:
I don't know the details.

[00:19:46] Speaker 02:
I would assume that it's pre-insertion.

[00:19:48] Speaker 02:
If the doctor screws it up, I don't know if they get the right of return or not.

[00:19:51] Speaker 02:
But the board actually went further.

[00:19:54] Speaker 02:
My friend on the other side here said the board did not consider the issue of commercial success.

[00:19:58] Speaker 02:
The board actually did.

[00:19:59] Speaker 02:
They said even if we consider units shipped to be units sold, which is what they asked, even if they were to make that step, which they didn't want to make, but even if they were, that information in isolation isn't helpful.

[00:20:12] Speaker 02:
The number of units sold in a given year doesn't tell you how much money came in the door, how many discounts were given, was that product bundled with another product.

[00:20:20] Speaker 02:
So that number of sales standing by itself does not provide evidence of commercial success.

[00:20:25] Speaker 02:
And that's what the board found.

[00:20:26] Speaker 02:
So on the issue of commercial success, there is one sliver of evidence units shipped.

[00:20:33] Speaker 02:
Incept truly had a product that was so market dominant, they would be flush with information they could produce on that topic.

[00:20:40] Speaker 02:
But they produced none of it.

[00:20:41] Speaker 02:
They produced units shipped.

[00:20:46] Speaker 01:
Thank you.

[00:20:47] Speaker 01:
Thank you, Your Honor.

[00:20:50] Speaker 03:
Yes, thank you, Your Honor.

[00:20:53] Speaker 03:
On the topic of Wallace, Wallace does not talk about removing by biodegradation.

[00:20:58] Speaker 03:
Again, it has, it's in column 19, it talks about an option of including biodegradable segments or blocks.

[00:21:05] Speaker 03:
It also talks in the patent about using that so you could release drugs, for example, from a composition.

[00:21:10] Speaker 03:
You could have a portion of the polymer degrade so a drug is released.

[00:21:14] Speaker 03:
But it's talking about an option of including these biodegradable segments.

[00:21:17] Speaker 03:
And it just doesn't talk about removing composition by having it degrade.

[00:21:23] Speaker 03:
And so that gets back to our point earlier about how no one's talking about inherency.

[00:21:28] Speaker 03:
The board didn't rely on inherency.

[00:21:30] Speaker 03:
The question is, does Wallace expressly disclose the same composition, the same arranged as claimed in claim one of the 723 patent?

[00:21:38] Speaker 03:
And we don't believe the evidence supports such a finding here.

[00:21:41] Speaker 03:
And the board's decision at the end

[00:21:44] Speaker 03:
Pendix 19, for example, even talks about in Wallace adapting compositions for different uses.

[00:21:49] Speaker 03:
In adapting, you're changing things in some way.

[00:21:51] Speaker 03:
And again, it's really an obvious analysis with Wallace that the board relied on and not an anticipation analysis.

[00:22:01] Speaker 03:
The claim 16, claim 6, we squarely raise those separately for why they're not obvious based on yesterday.

[00:22:10] Speaker 00:
Can I just be clear?

[00:22:11] Speaker 00:
So in the Wallace discussion of segments and blocks, we're not talking about

[00:22:16] Speaker 00:
Like, uh, I mean, an engine with big chunks that are segments.

[00:22:21] Speaker 00:
We're talking about, um, essentially molecule level segments, which if they biodegrade, the rest falls apart.

[00:22:31] Speaker 00:
So you are actually talking about the whole thing, um, disappearing.

[00:22:37] Speaker 03:
Well, Wallace refers, your honor, it is talking about molecules and it's the polymer may include biodegradable segments and blocks.

[00:22:44] Speaker 03:
And that's the level of detail it's at.

[00:22:47] Speaker 03:
And it talks about applications where, for example, a segment could degrade to release a drug.

[00:22:53] Speaker 03:
That would not be the entire molecule, the entire polymer, necessarily degrading.

[00:22:58] Speaker 03:
That would be a portion of it.

[00:23:00] Speaker 03:
And so that gets back to the point I was making about how Wallace just doesn't talk about removing something through biodegradation.

[00:23:07] Speaker 03:
It talks about having sections degrade and perhaps to release a drug.

[00:23:11] Speaker 03:
some other molecule for some other purpose, but it just doesn't talk about removing a composition by biodegradation.

[00:23:20] Speaker 03:
And then that's the example that we've highlighted for why the board's anticipation analysis was so flawed, that that's just not disclosed in Wallace.

[00:23:30] Speaker 03:
The board didn't rely on inherency, and Wallace doesn't talk about that.

[00:23:34] Speaker 03:
It doesn't disclose removing by biodegradation.

[00:23:37] Speaker 03:
And then on commercial success,

[00:23:39] Speaker 03:
touch on those points as well.

[00:23:42] Speaker 03:
There absolutely was evidence of actual sales.

[00:23:45] Speaker 03:
Incept did produce the evidence they relied because it was consistent throughout the records, was unit shipped.

[00:23:50] Speaker 03:
But in Ms.

[00:23:51] Speaker 03:
Ray's declaration that we submitted,

[00:23:53] Speaker 03:
She explains that, for example, in 2015, there was a little over a thousand units shipped, 914 of those are regular sales.

[00:23:59] Speaker 03:
2016, about 3,900 units shipped, about 3,700 of those were regular sales, 7,100 units and chains in 2017, and about 6,800 of those are regular sales.

[00:24:13] Speaker 03:
That's in her declaration.

[00:24:15] Speaker 03:
And so that's when she's talking about how

[00:24:17] Speaker 03:
We're talking about replacement units and samples.

[00:24:20] Speaker 03:
That's a small portion of the unit shipped.

[00:24:22] Speaker 03:
The bulk of the unit shipped are sales.

[00:24:25] Speaker 03:
And the other factors, too, the fact that Boston Scientific acquired Incept, that this reached commercial success so quickly.

[00:24:32] Speaker 03:
Dr. Shoalwater talked about it.

[00:24:33] Speaker 03:
He hadn't seen anything like this and how successful it was in his practice and how helpful it was in his practice.

[00:24:39] Speaker 03:
All of these, the totality of them, show evidence of commercial success that the board should have considered.

[00:24:45] Speaker 03:
And for that reason, on obviousness, we believe that we ask the court to respectfully remand the decision.

[00:24:52] Speaker 01:
Anything else?

[00:24:54] Speaker 01:
Any more questions?

[00:24:55] Speaker 01:
Thank you.

[00:24:56] Speaker 01:
Thanks to both counsel.

[00:24:57] Speaker 01:
Thank you.