[00:00:05] Speaker 04:
Okay the next case before the court, 172038 in Ray Marquez.

[00:00:13] Speaker 04:
It is another appeal from the Patent Trial and Appeal Board.

[00:00:34] Speaker 04:
This time from an examiner's rejection of an initial application or affirming an examiner's rejection of initial application.

[00:00:45] Speaker 04:
Mr. Dowd, you want three minutes?

[00:00:48] Speaker 01:
Yes, Your Honor.

[00:00:49] Speaker 04:
OK.

[00:00:49] Speaker 04:
All right.

[00:00:53] Speaker 01:
Thank you, Your Honor.

[00:00:54] Speaker 01:
May it please the court.

[00:00:54] Speaker 01:
My name is Matthew Dowd.

[00:00:56] Speaker 01:
I represent the appellants who are the inventors of the patent application at issue.

[00:01:02] Speaker 01:
I'd like to start off, although there are several issues raised in our appeal brief, I'd like to start off with three, I think, what are fundamental errors that the PTO and the board committed here.

[00:01:11] Speaker 02:
And one was raised in the PTO's... Your primary arguments are directed at claim construction.

[00:01:17] Speaker 02:
Correct, yes.

[00:01:18] Speaker 02:
If we reject your claim construction arguments, do we necessarily affirm each of the PTAS rejections?

[00:01:25] Speaker 01:
I think that's a fair position, Your Honor.

[00:01:27] Speaker 01:
I mean, our position really is that

[00:01:30] Speaker 01:
Although there are 101, 102, 103, 112 rejections, at the end of the day, they all fundamentally come down to the boards and the PTO's misconstruction of several key claim terms.

[00:01:42] Speaker 01:
Would you say enablement is the key issue?

[00:01:45] Speaker 01:
Enablement is a key issue for two reasons, Your Honor.

[00:01:49] Speaker 01:
One, because the PTO brings up the issue of whether we waive that, trying to come over those rejections.

[00:01:56] Speaker 01:
And then second,

[00:01:58] Speaker 01:
But fundamentally, the enablement rejection also goes back to the claim construction.

[00:02:04] Speaker 01:
And if I could turn to that for a minute.

[00:02:05] Speaker 02:
Yeah, let me just take you somewhere.

[00:02:08] Speaker 02:
Yes.

[00:02:08] Speaker 02:
That is, in the red brief at 15, the PTO says, the PTAB adopted Marquez's pro-offer construction of the claims relevant to the enablement requirement.

[00:02:20] Speaker 02:
Did they do that?

[00:02:22] Speaker 01:
Judge Wallach, I don't think so.

[00:02:23] Speaker 01:
There's no indication that

[00:02:25] Speaker 01:
either the examiner or the board ever accepted marquez's constructions of the claims and for example well was there something that in the record where marquez proposed a construction that the p tab rejected absolutely your honor okay where's that in the record yeah i mean it's throughout the record but let me let me turn to a specific claim for example claim term uh... claim term i'm talking about enablement enablement before we do that let me figure out which claims are at issue here

[00:02:53] Speaker 04:
You say that we should equitably waive waiver and that a lot more than claims 33 and 34 are here.

[00:03:03] Speaker 04:
But you admit that unless we reach that equitable conclusion that you will allow you to overcome your waiver as to all of the other claims, that we're limiting ourselves to the enablement and other conclusions on claims 33 and 34.

[00:03:19] Speaker 01:
Correct, Judge O'Malley.

[00:03:20] Speaker 01:
So if the court finds that,

[00:03:24] Speaker 01:
We did, in fact, waive the enablement rejections for all but claims 33 and 34.

[00:03:31] Speaker 01:
All of the rest of the arguments with respect to 101, 102, and 103 are rendered moot.

[00:03:37] Speaker 01:
So we accept that.

[00:03:38] Speaker 01:
But we also take the position.

[00:03:39] Speaker 04:
But only rendered moot if we agree with the board that they got the enablement rejection right on 33 and 34.

[00:03:48] Speaker 04:
In other words, if we ruled in your favor on enablement, then we would

[00:03:53] Speaker 04:
have to look at the 101 rejection as it relates to 33 and 34.

[00:03:58] Speaker 01:
I agree, Judge.

[00:04:00] Speaker 01:
And let me just turn to a couple of points I want to make before I get into more substance.

[00:04:05] Speaker 01:
And one was an issue that the PTO raised in its red brief.

[00:04:08] Speaker 01:
And the PTO takes the position that the evidence wasn't properly before the board because it relies on 37 CFR 41.67.

[00:04:16] Speaker 01:
That is an error on the PTO's part.

[00:04:21] Speaker 01:
But it's important because if that is still the PTO's position, then that alone is enough to reverse or vacate and remand because the PTO is taking the position that all of this evidence in the file history, the board didn't consider.

[00:04:34] Speaker 01:
And that would be an improper way to decide the appeal.

[00:04:38] Speaker 01:
But more fundamentally, in terms of the claim construction issues, one error was the PTO has always taken the position that these are product by process limitations.

[00:04:49] Speaker 01:
And that's fundamentally wrong.

[00:04:51] Speaker 01:
when we apply this court's precedent.

[00:04:54] Speaker 01:
And a recent case, Inray-Nort development that came out in February of this year, goes through and provides a two-step process of how we look at a claim and whether it's a product by process claim.

[00:05:05] Speaker 01:
And in that case, the invention was directed to an injection molded knee brace.

[00:05:13] Speaker 01:
And the PTO took the position that the term injection molded was product by process.

[00:05:18] Speaker 01:
This court rejected that, citing numerous cases,

[00:05:21] Speaker 01:
And that has always been our position here.

[00:05:23] Speaker 01:
So the term assembled, the PTM has always looked at that term assembled as to be a process limitation, meaning that there's no patentable weight given to it.

[00:05:35] Speaker 01:
But during prosecution from the very first office action, the examiner took the position that, well, this is a product by process limitation.

[00:05:43] Speaker 01:
Therefore, it has no patentable weight.

[00:05:45] Speaker 01:
But if you look at the specification, which you have to do,

[00:05:49] Speaker 01:
when you're looking at claim terms and trying to determine whether they are product by process limitation, it's clear that the term assembled refers to the characteristics of this non-natural construct.

[00:06:01] Speaker 01:
There is no dispute that these are non-natural constructs in terms of what's described in the application.

[00:06:09] Speaker 01:
They're individual cells that are first taken separately, and then they are assembled into a particular construct

[00:06:18] Speaker 01:
that uses electrostatic forces or hydrophobic forces, energy minimization forces, to create these novel constructs.

[00:06:27] Speaker 01:
And that's what the term assembled means.

[00:06:29] Speaker 01:
And so it's been always our position that regardless of whether you look at the 101, 102, 103, 112 rejections, the examiner has always been off base, the PTO, the board has always been off base because they've misunderstood the invention.

[00:06:46] Speaker 04:
agree with you that it's not a product by process claim.

[00:06:51] Speaker 04:
There are still other reasons for the enablement rejection upon which the PTO relied, aren't there?

[00:06:59] Speaker 01:
Correct, Your Honor, but that brings up another error that the PTO committed in terms of its enablement analysis.

[00:07:06] Speaker 01:
And this again pervades the prosecution history from the very first enablement rejection.

[00:07:13] Speaker 01:
And the examiner took the position that the applicant here had to enable in vivo uses of these artificial constructs.

[00:07:22] Speaker 01:
And I will readily admit to the court that there is some question about whether the specification as drafted and all the articles and evidence that are submitted as part of the prosecution history adequately enable in vivo uses.

[00:07:36] Speaker 01:
So for example, one of the uses of these constructs is to help in terms of organ reconstruction.

[00:07:42] Speaker 01:
There's no working example of that.

[00:07:44] Speaker 01:
There is no article that describes that being successfully done.

[00:07:48] Speaker 01:
So that's questionable.

[00:07:49] Speaker 01:
But it's also black letter law that in terms of claiming a composition of matter, it's sufficient to enable one use, to enable the claim to that composition of matter.

[00:08:02] Speaker 01:
And that's been our argument from day one during prosecution to the board and to this court.

[00:08:07] Speaker 01:
So what's the use?

[00:08:09] Speaker 01:
The use is for a

[00:08:10] Speaker 01:
an effective controlled release of some substance.

[00:08:15] Speaker 01:
It's similar to a controlled drug delivery device, whether it's in vitro, in a lab dish, or some sort of construct like that, whether it is in a body where it's controlled release of a substance.

[00:08:27] Speaker 01:
And that doesn't necessarily require that you have particular efficacy or particular safety.

[00:08:32] Speaker 01:
And there's one point in the final office action by the examiner in 2014

[00:08:38] Speaker 01:
where the examiner rejects the invention for enablement basically because the examiner takes the position that these uses aren't satisfactorily safe or effective.

[00:08:51] Speaker 04:
So all of that ignores a complete... Well, I think there's a difference between saying there has to be a use to which it could be put and something that's truly useful within the bounds of patent law.

[00:09:03] Speaker 01:
Correct, Judge O'Malley.

[00:09:05] Speaker 01:
But I think that brings us to

[00:09:07] Speaker 01:
another error in the board's reasoning.

[00:09:10] Speaker 01:
And it was my understanding that the PTO has now given up on this position with respect to the utility requirement, because it was clear from my reading of the board's decision that the PTO, the board was taking the position that these claims aren't enabled because they don't provide a specific utility under 112, inside the in-rate Fisher, which is a classic 112 utility requirement.

[00:09:31] Speaker 01:
Before this court, as I read the red brief, the PTO doesn't stand by that position.

[00:09:35] Speaker 01:
But it also undermines the entire analysis of whether there is a satisfactorily enabled use.

[00:09:42] Speaker 01:
And you're right.

[00:09:43] Speaker 04:
But the PTO specifically found that there was no mechanism described in the spec for this release that you're talking about.

[00:09:50] Speaker 04:
So where is it?

[00:09:53] Speaker 01:
No, you are not.

[00:09:54] Speaker 01:
No, I disagree with that in terms that there's no mechanism for the release.

[00:09:57] Speaker 04:
Well, you disagree with that, but that's what the PTO found, right?

[00:10:00] Speaker 04:
Well, I think... Well, tell me where in the spec you think there's a mechanism for the release.

[00:10:07] Speaker 01:
One moment, Your Honor.

[00:10:15] Speaker 01:
There is absolutely description of a mechanism for release.

[00:10:19] Speaker 01:
And in addition, if you look at the specification in connection with the numerous articles that were submitted and part of the file history, the idea of using these constructs

[00:10:34] Speaker 01:
to release a substance that's contained within the construct is not necessarily novel.

[00:10:40] Speaker 01:
And there's no dispute about how the process works.

[00:10:44] Speaker 01:
What's novel and non-obvious about this invention is instead of using chemicals such as polymers to create these colloidal zones, the inventors here for the first time use living cells to create the same structure and the same construct.

[00:11:02] Speaker 01:
They're held together by the same fundamental physical and chemical properties.

[00:11:07] Speaker 01:
And there's an expectation, a reasonable expectation that they would operate under the same manner.

[00:11:12] Speaker 01:
Now the examiner, and this has been our position also during prosecution and before this court, is that the examiner and the board never identified any scientific explanation or cited to any article that disputed the explanation and the rationale that's provided in the specification.

[00:11:30] Speaker 01:
that explains how these constructs work.

[00:11:37] Speaker 04:
All right.

[00:11:37] Speaker 04:
Well, can you point me to something specific where you think you described this mechanism of release?

[00:11:43] Speaker 04:
Somewhere in this appendix.

[00:11:45] Speaker 01:
All right.

[00:11:46] Speaker 01:
One minute, Your Honor.

[00:11:47] Speaker 01:
Thank you for your indulgence.

[00:11:53] Speaker 01:
And there are numerous examples.

[00:11:55] Speaker 01:
Let me turn to at least one working example.

[00:12:00] Speaker 01:
is the example that uses red blood cells.

[00:12:05] Speaker 02:
Give us a site, please.

[00:12:06] Speaker 02:
Sure.

[00:12:23] Speaker 01:
So an appendix page 100.

[00:12:30] Speaker 01:
OK.

[00:12:30] Speaker 01:
is example one, and this is another actual example that was constructed.

[00:12:35] Speaker 01:
So it's an actual working example, and I use yeast cells.

[00:12:42] Speaker 01:
And in addition to the description in the application itself, also part of the file history are publications that were published by the inventors confirming both the method of making this particular construct

[00:12:58] Speaker 01:
and also a method of using them in a controlled release function.

[00:13:05] Speaker 04:
And if I could turn you to that, I think that- I don't see anything in what you just cited to me that describes the mechanism of release.

[00:13:12] Speaker 04:
It describes how it's made.

[00:13:14] Speaker 04:
So you're saying we just need to extrapolate from that and say, because we could just assume that because it uses some natural cells, we'll just assume it will operate the same way?

[00:13:24] Speaker 01:
Not assume, Your Honor.

[00:13:27] Speaker 01:
It's a reasonable inference.

[00:13:28] Speaker 01:
But I think that brings us to an important point about an error that the examiner made and the PTO made throughout this whole process.

[00:13:34] Speaker 01:
They took the term artificial gland to require that these constructs had to function like a gland.

[00:13:43] Speaker 01:
There is no limitation.

[00:13:44] Speaker 01:
There's no requirement in the claim that they actually provide controlled release in the same fashion as an artificial gland.

[00:13:53] Speaker 01:
And looking back on it, this may be an instance where

[00:13:57] Speaker 01:
Instead of using artificial gland, another terminology should have been used.

[00:14:01] Speaker 01:
So I think in terms of your question, Judge O'Malley, it gets to the examiner's error in understanding the invention as requiring an actual characteristic or function that is similar to an artificial gland.

[00:14:15] Speaker 01:
That's not what these are.

[00:14:16] Speaker 01:
These are similar to colloidal zones that are made of chemicals.

[00:14:20] Speaker 01:
And there's no doubt based on the literature that's cited that those constructs, colloidal zones,

[00:14:26] Speaker 01:
provide some sort of release of the substance that's contained in them.

[00:14:31] Speaker 04:
Do you agree that if we don't wave the waiver, that we're looking at claims 33 and 34?

[00:14:52] Speaker 04:
That is correct.

[00:14:53] Speaker 04:
That is exactly my position.

[00:14:55] Speaker 04:
And if we were to agree with you on enablement, we don't need to look at all the other rejections.

[00:14:59] Speaker 03:
That is exactly correct.

[00:15:00] Speaker 02:
OK.

[00:15:01] Speaker 02:
I'd appreciate it if you'd start with your statement at 15 of the red brief that the board adopted Marquez's pro-offered construction of the claims requiring the cellular components to be isolated or separated from the cells and not located within the cells, which is your

[00:15:22] Speaker 02:
basically saying that you accepted their enablement construction.

[00:15:26] Speaker 03:
Well, it had to do with the fact that the examiner had construed 33 and 34 at one point to mean that the cell components could be.

[00:15:36] Speaker 02:
They disagreed.

[00:15:36] Speaker 02:
They agreed with the appellant instead.

[00:15:39] Speaker 03:
But that had to do with the prior art rejections and the eligibility rejections.

[00:15:45] Speaker 03:
And what the examiner had said initially is that for the purposes of those rejections,

[00:15:51] Speaker 03:
I construe this claim to not be limited to cell components by themselves, isolated, separated from cells.

[00:15:58] Speaker 03:
And therefore, they read on the prior art, which had complete cells.

[00:16:02] Speaker 03:
The board overturned that and reversed in terms of the prior art and the eligibility rejections.

[00:16:09] Speaker 03:
And therefore, those claims are not affirmed on eligibility or prior art rejections.

[00:16:14] Speaker 03:
But that doesn't change the enablement issue.

[00:16:16] Speaker 03:
And if I can turn to the enablement issue, I think it would be helpful to walk through what was going on here.

[00:16:21] Speaker 03:
Effectively, all of the claims were upheld on enablement grounds.

[00:16:33] Speaker 03:
And Marquez failed to make any arguments with respect to any claims except 33 and 34.

[00:16:41] Speaker 03:
And therefore, the board properly held those were waived and affirmed those rejections, and then soundly

[00:16:50] Speaker 03:
affirmed that examiner's rejections with respect to 33 and 34.

[00:16:54] Speaker 04:
Do you agree with your friend on the other side that the problem is that what the board was crying is they weren't understanding that the gland that was claimed, the artificial gland that was claimed, would have a use separate and apart from an in vitro use?

[00:17:12] Speaker 03:
No, that's not at all what was going on.

[00:17:15] Speaker 03:
And I'd be happy to walk through kind of what's in the specification just briefly, and then what the examiner did in their rejection.

[00:17:22] Speaker 03:
In the specification, and I think in the blue brief, Marquez has acknowledged that there are prophetic examples and non-prophetic.

[00:17:32] Speaker 03:
And principally, they point to example seven, which is what we were just looking at.

[00:17:37] Speaker 03:
Figure seven, I'm sorry, which he was just pointing to.

[00:17:41] Speaker 03:
the non-prophetic example.

[00:17:44] Speaker 03:
And all that's shown there, if I could just walk you through that, it's 168 of the record.

[00:17:57] Speaker 03:
All that's shown here in the top figure is they take, and this is explained at pages 97 to 100 of the record.

[00:18:07] Speaker 03:
What they do here is they have a microchannel, which is pictured at 710.

[00:18:11] Speaker 03:
They have an aqueous solution, which they explain includes cells, includes a gel precursor, and some other components like a buffer, et cetera.

[00:18:24] Speaker 03:
Then introducing oil, which is at 712.

[00:18:26] Speaker 03:
And then effectively, you get these droplets appearing at 713, which is a droplet, an aqueous solution containing cells.

[00:18:33] Speaker 03:
That's also shown in 72, the droplets.

[00:18:36] Speaker 03:
Then at 73, they add an acid.

[00:18:38] Speaker 03:
They lower the pH.

[00:18:40] Speaker 03:
The gel then solidifies in the center.

[00:18:42] Speaker 03:
And the cells migrate to the outside.

[00:18:44] Speaker 03:
So you have a gel surrounded by cells.

[00:18:48] Speaker 03:
And that's what's pictured on 74.

[00:18:50] Speaker 03:
So that is effectively most of what's in the specification.

[00:18:55] Speaker 03:
There's also example one, which I think the council

[00:18:59] Speaker 03:
My opposing counsel mentioned that is using yeast cells, but it's essentially doing the same thing.

[00:19:05] Speaker 03:
So what is not enabled?

[00:19:07] Speaker 03:
So beyond what the examiner then said, and they had a list of issues, and that is, sorry.

[00:19:22] Speaker 04:
Clearly these have to be man-made, right?

[00:19:25] Speaker 03:
These are man-made, but they don't look anything different than

[00:19:31] Speaker 03:
At the examiner's rejection, which is at pages 950.

[00:19:35] Speaker 04:
They don't look anything different.

[00:19:36] Speaker 04:
I mean, are you saying that if we get an artificial pancreas or an artificial anything else, that somehow, because it works the same, it's not patentable, even though it is not a product of nature?

[00:19:50] Speaker 04:
It's a product of man?

[00:19:51] Speaker 03:
This goes to the eligibility and the prior art rejections.

[00:19:55] Speaker 03:
I'll be happy to talk about this, but I wanted to finish with the enablement

[00:19:59] Speaker 04:
But I'm still having a hard time understanding what's not enabled.

[00:20:03] Speaker 04:
So what is it that you say?

[00:20:04] Speaker 03:
So that's where we can turn to the examiner's rejection, which is initially at 793 to 799.

[00:20:10] Speaker 03:
I'm sorry, at 950 to 953 of the reject of the record, but then was reiterated in the examiner's answer at 793 to 797.

[00:20:19] Speaker 03:
And they had a list of things.

[00:20:20] Speaker 03:
And the one was, of course, the fact that gland has a well-known meaning in the art.

[00:20:25] Speaker 03:
One understands a gland to be things like pituitary,

[00:20:28] Speaker 03:
and adrenaline and so forth.

[00:20:30] Speaker 03:
And you've not shown that these things act like a gland that produces a substance that then has activity elsewhere.

[00:20:36] Speaker 03:
So that was one.

[00:20:37] Speaker 03:
But they also said other issues.

[00:20:40] Speaker 03:
They talked about the fact that the reservoir in the specification is described as being a gas, a liquid, or a gel.

[00:20:47] Speaker 03:
They said you've provided no evidence on how a gas could be effective and work in the same way that a gel can.

[00:20:54] Speaker 03:
The examiner also said that there's no guidance in terms of drug delivery.

[00:20:58] Speaker 03:
So you have absolutely none of these.

[00:21:01] Speaker 03:
Most of this is prophetic.

[00:21:02] Speaker 03:
And if you look, in fact, examples 7 to 21 is basically a wish list of how this could be used.

[00:21:09] Speaker 04:
Well, are you saying that the word artificial doesn't modify the word gland at all?

[00:21:16] Speaker 04:
So you agree that what basically the examiner said is you can't be enabled unless you work exactly like a human gland.

[00:21:26] Speaker 03:
That was one issue, OK?

[00:21:28] Speaker 03:
the bulk of the examiner's rejection.

[00:21:31] Speaker 03:
One issue is that you're using a term that's well established in the art.

[00:21:33] Speaker 03:
You haven't separately defined it in the specification.

[00:21:36] Speaker 03:
And therefore, that's just one issue.

[00:21:37] Speaker 03:
But there are a multitude of issues that the examiner raised that I'm going through.

[00:21:40] Speaker 02:
It seems what the examiner is saying that it's not an abler unless it works, leaving aside exactly like.

[00:21:52] Speaker 03:
One issue is it doesn't work like a gland.

[00:21:54] Speaker 03:
The other issues is that you haven't shown how to do this with something like a gas.

[00:21:59] Speaker 03:
The other issues is that you haven't shown any guidance on drug delivery, which is one of the principle things that you say you could be used for.

[00:22:07] Speaker 03:
There's absolutely no guidance in terms of tissue or organ regeneration.

[00:22:11] Speaker 03:
That's a very unpredictable art.

[00:22:13] Speaker 03:
There's really nothing known or not been much success in that area.

[00:22:18] Speaker 03:
So the examiner raised a host of issues.

[00:22:20] Speaker 04:
I guess what I'm trying to understand is it seems like the examiner said,

[00:22:23] Speaker 04:
well, OK, you've come up with this cool invention, but I think you should have come up with a cooler invention that covers a lot more stuff.

[00:22:33] Speaker 04:
And so isn't the examiner asking that more be enabled than actually is being claimed?

[00:22:39] Speaker 03:
No, what the examiner is saying is that, yes, we grant you that you have this very limited example, and you've developed this sort of structure, but you haven't shown in any way how to use it

[00:22:53] Speaker 03:
In particular, in claims 33 and 34, using cell components, which is very different.

[00:22:59] Speaker 03:
And you haven't shown how to use any of these things.

[00:23:02] Speaker 03:
So like we said, with respect to all these arguments that the examiner made, in response, in the appeal brief before the board, Marquez, at pages 730 to 733 of the record, only argued claims 33 and 34.

[00:23:18] Speaker 03:
They waived all the other issues.

[00:23:21] Speaker 04:
All right, we agree with the waiving, or I am for purposes of this argument.

[00:23:27] Speaker 04:
So are you saying that if they claimed less, I mean, if they discussed less in the specification about where this might take us in the future, that then it would be more enabled?

[00:23:37] Speaker 03:
No.

[00:23:39] Speaker 04:
I'm really having a hard time following this argument.

[00:23:41] Speaker 03:
There are two parts of it, the two parts.

[00:23:43] Speaker 03:
One is how to make, and one is how to use.

[00:23:45] Speaker 03:
And let's focus on claims 33 and 34, because those are the principal ones that were not waived.

[00:23:50] Speaker 03:
Respect to claims 33 and 34.

[00:23:53] Speaker 03:
And I just wanted to raise that as a backdrop, that there were a lot of issues going on, and much of which was not argued, was not disputed before the board by Marquez.

[00:24:02] Speaker 03:
So those arguments were waived.

[00:24:04] Speaker 03:
With respect to claims 33 and 34, what the examiner said is that the only guidance with respect to cell components, and that's at paragraph 59 in the specification,

[00:24:21] Speaker 03:
which is largely just a recitation of various things that could be used, various cellular components that could be used, everything from enzymes to growth factors to antibodies to organelles within the cell, things like mitochondria and endoplastic reticulum, chloroplasts, DNA, RNA, everything under the sun, essentially.

[00:24:43] Speaker 03:
And the examiner said, you have not provided guidance on how in the world you would make some kind of a

[00:24:50] Speaker 03:
what they call a gland, using these things.

[00:24:52] Speaker 00:
So it's a list of ingredients without any instructions on how to put them together.

[00:24:56] Speaker 00:
Right.

[00:24:57] Speaker 00:
And the only examples in the specification use cells, not cell components.

[00:25:02] Speaker 03:
Exactly.

[00:25:03] Speaker 03:
And in fact, the examiner even said, it's well known that cells naturally adhere to one another.

[00:25:09] Speaker 03:
There's no evidence that these sorts of things would do that and would operate similarly.

[00:25:12] Speaker 00:
Is there any evidence in the record that cell components would just operate in the same way that cells do, that a skilled partisan would understand

[00:25:20] Speaker 00:
that this is just basic science?

[00:25:23] Speaker 03:
No.

[00:25:23] Speaker 03:
And that's exactly what the examiner and the board said, that there is nothing in the prior art.

[00:25:27] Speaker 03:
And this is the board's decision at pages 30 to 31 of the record and the examiner's decision at 812 to 815.

[00:25:38] Speaker 03:
They basically said there is nothing other than this paragraph 59.

[00:25:42] Speaker 03:
There is no teaching about cellular components.

[00:25:45] Speaker 03:
There is no citation to prior art that would

[00:25:48] Speaker 03:
provide guidance in terms of how you would assemble cellular components.

[00:25:52] Speaker 03:
And given that, there is really not enough in the specification to guide a person's skill in the art to construct some kind of glands using cellular components.

[00:26:07] Speaker 03:
And furthermore, they said there's no teaching about how to make, but also similarly, like with the ones with cells, there's no teaching about how to use.

[00:26:15] Speaker 03:
And if I may, like they examined

[00:26:18] Speaker 03:
board recognized, for example, that the introduction of the specification describes potential uses being stem cell engineering, organ and tissue repair and replacement, a lot of big ideas.

[00:26:37] Speaker 03:
What about the yeast example?

[00:26:39] Speaker 03:
Doesn't that seem to be enabled?

[00:26:42] Speaker 03:
They teach you how to make, again, all that is taught.

[00:26:45] Speaker 03:
And it's very much like what we just looked at in Figure 7.

[00:26:47] Speaker 03:
is a gel with yeast around it.

[00:26:50] Speaker 03:
But in terms of how to use that, in terms of drug delivery, they actually have no examples in here of putting something in the middle and getting successful delivery of a drug, administering to a human and getting drug delivery, or even in vitro drug delivery.

[00:27:05] Speaker 03:
So they don't have any sort of examples of drug delivery, certainly no examples of getting tissue regeneration, doing tissue repair or replacement.

[00:27:17] Speaker 03:
And examples 7 to 21 have a whole host of things.

[00:27:21] Speaker 03:
They talk about treating diabetes and cystic fibrosis, lung disease.

[00:27:26] Speaker 04:
But again, those are just prophetic that someday it might be helpful.

[00:27:29] Speaker 04:
Do we have any case law that says if you say something like that, that you therefore have to enable every one of those things?

[00:27:35] Speaker 04:
You don't have to enable any of those, especially if you're not claiming that.

[00:27:38] Speaker 03:
But you have to enable something.

[00:27:38] Speaker 03:
And here we have basically no enabled use.

[00:27:41] Speaker 03:
We're stuck with no enabled use because all the uses are effectively prophetic, and they haven't shown us any uses.

[00:27:47] Speaker 03:
And more importantly, they haven't showed us how to make such structures using cell components.

[00:27:52] Speaker 03:
And as a consequence, there's simply a lack of guidance on the specification, and the invention is not enabled.

[00:28:00] Speaker 02:
Just out of curiosity, in the gray brief, Marquez claims that the PTO concedes the spec satisfies the utility requirement under 112.

[00:28:14] Speaker 02:
Do you concede it, and if you do, does that have any impact on enablement?

[00:28:20] Speaker 03:
I don't think it has any impact.

[00:28:21] Speaker 03:
We did not separately argue the utility.

[00:28:23] Speaker 03:
That was sort of an alternative ground that the board cited through utility and made arguments about utility.

[00:28:29] Speaker 03:
We don't think it's necessary to go there.

[00:28:32] Speaker 03:
We rest on the enablement entirely on enablement, and we think it's completely defensible on that ground.

[00:28:46] Speaker 04:
We have 1.20 for Roberto.

[00:28:48] Speaker 01:
Thank you, Your Honor.

[00:28:55] Speaker 01:
Judge Wallach, to answer your question, I think the case law is clear.

[00:28:57] Speaker 01:
If we raise an argument in our blue brief and the PTO doesn't respond to it in the red brief, it's considered conceded.

[00:29:04] Speaker 01:
Not that it resolves the question here, Your Honor.

[00:29:07] Speaker 01:
But Judge Hughes, to answer your question about whether cell components operate in the same way as cells, I think what the board did

[00:29:16] Speaker 01:
incorrectly here is ignore all the evidence where we have an established field that uses smaller chemical components to make colloidal zones and we have evidence in the specification that uses cells.

[00:29:32] Speaker 01:
We've described that they operate on the same basic scientific principles and the board never responded to that other than a single sentence which is at I believe A33 and they don't provide, the board doesn't provide an explanation of why

[00:29:47] Speaker 01:
it disagrees with the statement in the specification about how these operate.

[00:29:52] Speaker 01:
And under this court's case law, that's not sufficient for the PTO to do.

[00:29:56] Speaker 01:
They have to provide some explanation of why the applicant's explanation of why the invention works the way it does is not reasonably believable by a person of skill in the art.

[00:30:08] Speaker 01:
And I will point as one last point, Your Honor.

[00:30:12] Speaker 04:
You never provided a working example of claims 33 and 34, did you?

[00:30:17] Speaker 01:
No, Your Honor, we did not of the cellular components.

[00:30:22] Speaker 01:
There's no working example of that, but we would point the court to the independent research by the UK group that shows that there is a use that these can be made in terms of the cell constructs, and we find that... Those post-dated the date of application?

[00:30:39] Speaker 01:
Correct, Your Honor, but the law is clear that you can rely on post-filing evidence to confirm

[00:30:45] Speaker 01:
the enablement of a specification that's filed earlier, if you're following what's taught in the specification.

[00:30:50] Speaker 04:
But you don't point out that any in vitro testing was done, right?

[00:30:54] Speaker 04:
I'm sorry, in vivo.

[00:30:56] Speaker 01:
In vivo testing?

[00:30:57] Speaker 01:
Yeah.

[00:30:57] Speaker 01:
Correct, Your Honor.

[00:30:59] Speaker 01:
There's been no in vivo testing.

[00:31:00] Speaker 01:
And our position is that based on the in vitro uses of the similar chemical-based constructs and the working examples that we've shown here, and the absence of any scientifically

[00:31:13] Speaker 01:
based explanation by the board that's sufficient to show that our claimed constructs are enabled.

[00:31:20] Speaker 01:
Unless there are any further questions?

[00:31:22] Speaker 04:
No.

[00:31:22] Speaker 04:
Thank you.

[00:31:23] Speaker 01:
Thank you, Your Honors.

[00:31:26] Speaker 04:
All right.

[00:31:26] Speaker 04:
The next case before the court.