[00:00:00] Speaker 04:
is 21-1038 Morelos versus Equestive Therapeutics.

[00:00:07] Speaker 04:
Ms.

[00:00:08] Speaker 04:
Devine, please proceed when you're ready.

[00:00:12] Speaker 03:
Thank you, Your Honor.

[00:00:27] Speaker 03:
Good morning.

[00:00:28] Speaker 03:
Wendy Devine on behalf of Neuralis Incorporated.

[00:00:31] Speaker 03:
The Board's obviousness findings are based on a legally flawed conclusion regarding priority.

[00:00:37] Speaker 03:
Specifically, the Board's decision should be reversed because the Board erred in two ways.

[00:00:43] Speaker 03:
First, the Board improperly interpreted dependent claims 26-28 and 30-33, which recite Doe-Dessel-Malticide.

[00:00:53] Speaker 03:
The board interpreted those claims as requiring nothing more than the alkylglycoside limitation of independent claim one.

[00:01:02] Speaker 03:
This error led the board to disregard these dependent claims and fail to address the undisputed support for dodecylmalticide in the provisional application.

[00:01:15] Speaker 03:
Second, with respect to the alkylglycoside limitation of the remaining claims, the board failed to apply

[00:01:22] Speaker 03:
the correct legal standard in that it first required a disclosure of a preference for the claimed embodiment as opposed to evidence of possession of the claimed embodiment and then it misapplied the law regarding incorporation by reference resulting in a failure to treat the entirety of the six pages of the Sigma catalog which are indisputedly incorporated into the provisional application as incorporated.

[00:01:51] Speaker 03:
Now I'd like to begin with the first error, which specifically relates to six of the dependent claims.

[00:01:57] Speaker 03:
The board erroneously interpreted the scope of those six claims.

[00:02:01] Speaker 03:
Independent claim one, from which those six claims depend... Before you go into the merits, would you just address the

[00:02:08] Speaker 04:
waiver argument because I understand your opponent to suggest that you didn't make this argument below.

[00:02:15] Speaker 04:
It was made only in a single footnote in passing and not a developed argument.

[00:02:21] Speaker 04:
So can you show us where you made this argument below in a way that alerted the board to the fact that you were separately arguing dependent claims and not just hinging your argument on a representative claim as

[00:02:35] Speaker 04:
lawyers often do in these cases.

[00:02:38] Speaker 03:
Certainly, Your Honor.

[00:02:39] Speaker 03:
If we turn to Appendix 487, and we did make this argument in a footnote.

[00:02:48] Speaker 04:
Page 487.

[00:02:49] Speaker 03:
Appendix 487.

[00:02:59] Speaker 03:
In this footnote, we reference the testimony of petitioner's expert, Dr. Pepes, in his cross-examination, his deposition about his declaration that supported the petition.

[00:03:09] Speaker 03:
And we state, and I quote, Dr. Pepes agreed that the Sigma catalog, that's the document that was incorporated by reference into the provisional application, includes alkylglycoside specifically identifying dodecylmalticide.

[00:03:24] Speaker 03:
And then we further note

[00:03:26] Speaker 03:
that dodecylmalticide is what is claimed in these six claims and is what is disclosed in that sigma catalog entry.

[00:03:34] Speaker 03:
Now for context, Your Honor, at this point in the proceeding it was undisputed that dodecylmalticide was disclosed in the sigma catalog and recognized by a person of skill in the ARC.

[00:03:46] Speaker 03:
Patent owner's expert, Dr. Gesersen, said that it was his opinion that that was the case.

[00:03:51] Speaker 03:
Dr. Pepys,

[00:03:53] Speaker 03:
Petitioner's expert said that he agreed that that was what is disclosed in the Sigma catalog.

[00:03:59] Speaker 03:
Now, notably, petitioner in their petition did not even address the Sigma catalog.

[00:04:04] Speaker 03:
They did not put it in the record.

[00:04:06] Speaker 03:
They did not acknowledge its content.

[00:04:09] Speaker 03:
And they only made a conclusory statement that somehow alkyl glycosides and specifically dodecyl multicide were not disclosed, described, or enabled.

[00:04:20] Speaker 03:
In the institution decision, the board cited a rule of prosecution to state that the incorporation of the Sigma catalog was somehow improper because you cannot incorporate essential material.

[00:04:34] Speaker 03:
That justification that the board provided for the petitioner was abandoned in the final written decision.

[00:04:40] Speaker 04:
So what's the point of that?

[00:04:41] Speaker 04:
The board made a mistake in the institution decision when it said it wasn't incorporated, and then they overcame that mistake in their final decision by treating it as incorporated.

[00:04:51] Speaker 04:
So we all make mistakes.

[00:04:54] Speaker 04:
They were smart enough to recognize it and overcome it.

[00:04:57] Speaker 04:
So how does that help you?

[00:04:58] Speaker 04:
What's the point?

[00:04:59] Speaker 03:
When we filed this patent owner response, the context of that was what was laid out.

[00:05:04] Speaker 03:
The issue that was identified by the petitioner

[00:05:08] Speaker 03:
with a lack of disclosure of alkyl glycosides and specifically dodecyl malticide that did not acknowledge, analyze, or discuss a document that at this point in the proceeding is indisputably incorporated by reference into the provisional disclosure.

[00:05:25] Speaker 03:
So when we were filing this response, there was no discussion that that

[00:05:31] Speaker 03:
disclosure that literal disclosure of dodecyl malticide was somehow insufficient to provide written description for a claim that claims dodecyl malticide.

[00:05:41] Speaker 04:
Well, but the problem for me, and I struggle with this, it's a consisting of claim.

[00:05:46] Speaker 04:
It's not a comprising claim.

[00:05:48] Speaker 04:
So you have a disclosure that's incorporated by a reference that discloses, I don't know, 150 different

[00:05:56] Speaker 04:
things.

[00:05:57] Speaker 04:
How many does it disclose?

[00:05:58] Speaker 04:
200?

[00:05:58] Speaker 04:
I don't know how many.

[00:06:00] Speaker 03:
There are a number of compounds.

[00:06:01] Speaker 03:
I believe it's over 100, but they are categorized.

[00:06:04] Speaker 04:
In the sigma, in that sigma document, I think it's over 150, isn't it?

[00:06:09] Speaker 04:
Something like that.

[00:06:10] Speaker 03:
I think that's about right.

[00:06:11] Speaker 04:
Okay.

[00:06:11] Speaker 04:
So it discloses 150 different possible

[00:06:15] Speaker 04:
Are these compounds?

[00:06:17] Speaker 03:
Compounds, yes.

[00:06:17] Speaker 04:
Okay.

[00:06:18] Speaker 04:
I'm sorry.

[00:06:19] Speaker 04:
I'm doing my best here.

[00:06:20] Speaker 04:
So 150 different compounds.

[00:06:22] Speaker 04:
Then you have this consisting of claim, which means this and only this.

[00:06:28] Speaker 04:
How does a disclosure of 150 random compounds satisfy the need to show possession of this and only this?

[00:06:41] Speaker 03:
So to begin with, that disclosure of all of those compounds are categorized, and that disclosure must be read from the perspective of a person of skill in the art.

[00:06:49] Speaker 03:
And when the incorporation by reference appears in the provisional catalog, what it says is you can have these certain agents, some of them are surface acting agents, which are surfactants,

[00:07:02] Speaker 03:
and preferably non-ionic versions of those.

[00:07:06] Speaker 03:
Then it goes on to say, also, these biological detergents that are disclosed in the six pages of the Sigma catalog.

[00:07:13] Speaker 03:
Now, biological detergents are surface acting agents.

[00:07:15] Speaker 03:
They're surfactants.

[00:07:16] Speaker 03:
That's not disputed in the record.

[00:07:19] Speaker 03:
Petitioner's expert said so at deposition.

[00:07:23] Speaker 03:
What it's pointing you to is the sigma catalog and saying, look at the biological detergents here, and in particular, look at the non-ionic ones.

[00:07:30] Speaker 03:
And if you turn to the first page of the sigma catalog.

[00:07:33] Speaker 00:
One way or the other, isn't it the specification itself that's got to show possession and not extraneous documents?

[00:07:41] Speaker 03:
The Sigma catalog is incorporated by reference and at this point it is undisputed.

[00:07:45] Speaker 03:
The board accepted that it is incorporated by reference into the provisional application.

[00:07:51] Speaker 03:
So what that means is it has to be taken in its entirety with all that it discloses and placed inside the specification.

[00:07:59] Speaker 03:
So it's not an extraneous document, it is part of the specification.

[00:08:04] Speaker 03:
So we can look at the pages of the Sigma catalog and say, this is the specification of the provisional disclosure.

[00:08:11] Speaker 03:
And if I may direct your honors to the appendix where that sigma catalog appears, appendix 10705.

[00:08:23] Speaker 03:
This page in particular exemplifies our point.

[00:08:26] Speaker 03:
So here you have selected detergents, biological detergents.

[00:08:31] Speaker 03:
The specification has told you these biological detergents are part of the inventor's invention.

[00:08:36] Speaker 03:
And they pointed you specifically to the non-ionic ones.

[00:08:40] Speaker 03:
And within these selected detergents, if you look towards the bottom, the non-ionic compounds listed, there's ten of them.

[00:08:46] Speaker 03:
Seven of them are alkyl glycosides.

[00:08:49] Speaker 03:
And Petitioner's own expert readily recognized them as alkyl glycosides at his deposition, without hesitation.

[00:08:56] Speaker 02:
To be absolutely clear, when were the claims to the species that we seem to be concerned with, the dodecal multicide, when were those claims added?

[00:09:08] Speaker 02:
I gather they were not in the provisional, is that right?

[00:09:11] Speaker 03:
That's correct.

[00:09:12] Speaker 03:
They were in the utility application that followed the provisional, which claims priority to the provisional.

[00:09:18] Speaker ?:
OK.

[00:09:19] Speaker 03:
So there is literal support for the dodecylmalticide limitation.

[00:09:24] Speaker 03:
There can be no doubt about that if you are actually accepting the incorporation by reference, which is not in dispute.

[00:09:31] Speaker 03:
Moving to the alkylglydecine.

[00:09:33] Speaker 04:
When you say there's literal support, I mean the problem is even if I were to agree, which the board did not, the board did not agree that

[00:09:42] Speaker 04:
as a factual matter, you had pointed people to using, in particular, non-ionic detergents.

[00:09:50] Speaker 04:
As a factual matter, I'd have to say there's no substantial evidence for that board of fact-finding to get there.

[00:09:55] Speaker 04:
But there are, I think, in excess of 60 non-ionic detergents listed, only a handful of which are alkyl glycosides and only one of which is dodecyl malticide.

[00:10:10] Speaker 04:
So you have

[00:10:12] Speaker 04:
and incorporated by reference disclosure with 150 compounds in it, 60 under the header non-ionic detergent.

[00:10:21] Speaker 04:
How did the inventor show possession of this and only this because of the consisting of language?

[00:10:28] Speaker 04:
So to the exclusion of the other 59 non-ionic detergents that are listed.

[00:10:33] Speaker 03:
So the consisting of language does not change the legal standard, which requires only that the inventor show that they possessed what was claimed in the priority document.

[00:10:43] Speaker 03:
It does not mean that the priority document must be restricted to and only describe that one embodiment.

[00:10:49] Speaker 03:
The inventor was in possession of all of the embodiments.

[00:10:52] Speaker 04:
The only question to be asked is... How can you say the inventor was in possession of all of the embodiments?

[00:11:01] Speaker 04:
There are all kinds of compounds in here that wouldn't satisfy these claims or even the goal of these claims.

[00:11:10] Speaker 04:
You're telling me the inventor is in possession of all 150 possible compounds listed in the sigma reference, even though many of them would absolutely not function as a method for treating a patient with this disorder?

[00:11:26] Speaker 03:
Yes, and my response to that is that the specification, the priority disclosure, and the claims do not need to be coextensive.

[00:11:34] Speaker 03:
The inventor is entitled to claim one of the embodiments that is disclosed in the specification and to disclose other embodiments that may be claimed later or may not be.

[00:11:45] Speaker 03:
The question to be asked on whether there is written description support in the provisional application is not whether there is pointing to this and only this embodiment in the provisional application.

[00:11:56] Speaker 03:
The question to be asked is, a person of skill in the art reading this disclosure, do they readily recognize that the inventor was in possession of what they are claiming at the time that the provisional was filed?

[00:12:08] Speaker 03:
And the answer here is yes.

[00:12:10] Speaker 03:
Does it show that the inventor was in possession of other embodiments of the invention?

[00:12:14] Speaker 03:
Yes.

[00:12:15] Speaker 03:
But it does not require that it be limited only to a disclosure of the particular claimed embodiment.

[00:12:23] Speaker 04:
When you say, does it show the inventor was in possession of other embodiments, I see no evidence in this patent or otherwise that other than the alkyl glycosides, the other 143 different compounds listed in the sigma reference would have worked at all.

[00:12:45] Speaker 04:
So what we have is an inventor who threw out 150 compounds

[00:12:50] Speaker 04:
in a provisional.

[00:12:52] Speaker 04:
These provisional applications get filed before inventors have really honed in on what their precise invention is.

[00:13:00] Speaker 04:
He or she threw out a provisional, which incorporated by reference all of these compounds, but then later determined only a small handful of them

[00:13:11] Speaker 04:
actually worked or were worth claiming or what?

[00:13:15] Speaker 04:
I don't know.

[00:13:15] Speaker 04:
And that's why, how are we supposed to figure out the inventor possessed as of the date of the provisional, the fact that these particular ones would have worked?

[00:13:28] Speaker 03:
So I agree with Your Honor that if the inventor is going to claim something, there has to be both written description and enablement.

[00:13:34] Speaker 03:
The person of skill in the art has to be able to practice the invention.

[00:13:37] Speaker 03:
But the question at issue here for priority is not the enablement.

[00:13:41] Speaker 03:
It is the written description.

[00:13:43] Speaker 03:
And did the inventor convey that this was part of their invention at the time of the filing of the provisional?

[00:13:49] Speaker 03:
And the inventor did point to dodecylmalticide.

[00:13:52] Speaker 03:
There is literal support in the written description for that claim limitation.

[00:13:58] Speaker 03:
That is just a matter of fact that cannot be disputed.

[00:14:01] Speaker 04:
You say there's literal support in the written description.

[00:14:04] Speaker 04:
You mean because dodecylmulticide is one of 150 different compounds articulated in the sigma reference.

[00:14:14] Speaker 03:
So because dodecylmulticide appears in the specification, yes, as part of that incorporation.

[00:14:21] Speaker 04:
It appears in the specification by virtue of the incorporation.

[00:14:25] Speaker 04:
Correct.

[00:14:25] Speaker 04:
Not separately.

[00:14:27] Speaker 04:
Correct.

[00:14:28] Speaker 04:
So did the inventor, just out of curiosity, possess claim one, but without an alkyl glycoside, suppose instead we added lithium salt, which is one of the anionic detergents listed in the sigma reference.

[00:14:43] Speaker 04:
Did the inventor possess this method of treating a patient

[00:14:48] Speaker 04:
with this disorder, so a method of treating a patient assumes as part of the construction that it would actually treat the patient, right?

[00:14:57] Speaker 04:
Is that fair?

[00:14:58] Speaker 04:
Correct.

[00:14:58] Speaker 04:
Yeah.

[00:14:59] Speaker 04:
So did this inventor possess this method precisely, instead of except for the words and an alcohol glycoside, we stick in lithium salt?

[00:15:08] Speaker 04:
Did he possess that compound, that particular method?

[00:15:11] Speaker 03:
That would have to be assessed from the perspective of a person of skill in the art and if that was the claim at issue.

[00:15:16] Speaker 04:
But you're telling me the fact that he incorporated by reference something with 150 compounds means he possessed all 150.

[00:15:26] Speaker 03:
It's not a laundry list of 150 compounds to begin with.

[00:15:30] Speaker 03:
It is a categorized disclosure of different compounds.

[00:15:33] Speaker 03:
And the specification does specifically call out that non-ionic is what is important.

[00:15:38] Speaker 04:
The board disagreed with you on that as a factual matter.

[00:15:42] Speaker 04:
The board did not agree that the sigma reference was limited to the 60 compounds listed as non-ionic detergent.

[00:15:51] Speaker 03:
Yes, but the board did not disagree that the biological detergents that are disclosed in these six pages are incorporated into the specification.

[00:15:59] Speaker 04:
So that's 150.

[00:16:01] Speaker 04:
So 150 things are incorporated into the specification, most of which probably don't work to treat somebody with this condition.

[00:16:14] Speaker 03:
So Your Honor, that's a question of enablement on a claim that's not an issue.

[00:16:18] Speaker 03:
Enablement was not an issue.

[00:16:20] Speaker 04:
You're asking me to conclude that a fact finding the board made about what the inventor possessed at a very early time, the provisional application, whether to overturn a fact finding about what an inventor possessed.

[00:16:32] Speaker 04:
And you're doing it based simply on a large scale disclosure of 150 compounds.

[00:16:40] Speaker 03:
So the board did not make a finding based on possession.

[00:16:44] Speaker 03:
They made a finding based on preference, which was their legal error.

[00:16:47] Speaker 03:
That is not the standard.

[00:16:49] Speaker 03:
The specification does not need to show a preference for the dodecylmalticide.

[00:16:53] Speaker 03:
It need only show possession.

[00:16:56] Speaker 03:
So that is where the board got it wrong.

[00:16:59] Speaker 03:
They applied the incorrect legal standard

[00:17:02] Speaker 03:
to the facts.

[00:17:03] Speaker 03:
And what the facts show, the only testimony of record are from patent owner's expert and petitioner's initial expert that they readily recognize alkyl glycosides as a subgenus and dodecyl multicide specifically in the specification of the provisional document.

[00:17:20] Speaker 00:
So what's your strongest evidence or position on the alkyl glycosides in the provisional?

[00:17:25] Speaker 03:
It's the Sigma catalog, and for dodecylmalticide in particular, it's part of the specification.

[00:17:31] Speaker 03:
That compound appears in the specification as part of the written description.

[00:17:36] Speaker 03:
That is what the inventor said, this is what I've invented, this is my invention, when they filed their provisional application.

[00:17:43] Speaker 04:
Okay, well you've used all of your time and all of your rebuttal time, so why don't we hear from Mr. Scola, please?

[00:17:49] Speaker 04:
Thank you, Your Honor.

[00:18:10] Speaker 01:
Good morning.

[00:18:11] Speaker 01:
May it please the court?

[00:18:13] Speaker 01:
The board's decision was based on substantial evidence, based on the testimony of requestive experts, that there was no written description for apoglycosides or dodecylmalticide.

[00:18:25] Speaker 04:
Just as a matter of housekeeping, you agree that the board's original conclusion in the petition that this wasn't incorporated by reference was modified in the final decision and the sigma disclosure, these six pages, are considered incorporated by reference to the material?

[00:18:43] Speaker 01:
Yes, certainly.

[00:18:44] Speaker 04:
Just as a housekeeping matter, I just wanted to do that.

[00:18:46] Speaker 01:
Yes.

[00:18:46] Speaker 01:
Go ahead.

[00:18:48] Speaker 01:
The board also found substantial evidence for the motivation to combine the references.

[00:18:52] Speaker 01:
And when those references were combined,

[00:18:55] Speaker 01:
There was a preponderance of evidence that led to the uncontinability of all the claims.

[00:19:04] Speaker 01:
I would like to address a couple of points before I get into written description.

[00:19:09] Speaker 01:
The first is Norellis' argument that with respect that there was not proper notice given in respect to the Sigma catalog and written description.

[00:19:19] Speaker 01:
Under dynamic drinkware, Equesta fulfilled its burden of production when it asserted invalidating prior art against the 876 claims.

[00:19:29] Speaker 01:
It was not required to recite the Sigma catalog.

[00:19:33] Speaker 01:
Once that invalidating prior art was cited, the burden of production shifted to Nivalis.

[00:19:38] Speaker 01:
That's all that's required under dynamic drinkware.

[00:19:43] Speaker 01:
In the petition, we did go a step further.

[00:19:46] Speaker 01:
And we did give notice that was no written description with respect to alcohol glycosides and no decimalicide.

[00:19:54] Speaker 01:
We did that in the appendix at 225.

[00:20:01] Speaker 01:
The point about the waiver of the dependent claims, during oral argument, Judge Turnquist

[00:20:12] Speaker 01:
asked the following, and I quote, Council, this is Judge Turnquist.

[00:20:16] Speaker 04:
What page are you reading from in the appendix?

[00:20:18] Speaker 01:
803 in the appendix.

[00:20:20] Speaker 01:
That's when the question was asked.

[00:20:23] Speaker 01:
And then the next page is 829.

[00:20:26] Speaker 01:
That's when it was answered.

[00:20:30] Speaker 01:
Judge Turnquist.

[00:20:32] Speaker 01:
Council, this is Judge Turnquist.

[00:20:34] Speaker 01:
I have maybe a follow-up question.

[00:20:36] Speaker 01:
Where in the patent owner response do you address the claim, the claims as a whole for written description support?

[00:20:43] Speaker 01:
Council's answer was, regarding your honor's questions regarding whether we laid out in our papers the provisional support for each and every limitation of the claims, it's not explicitly here.

[00:20:55] Speaker 01:
And that's the waiver of the dependent claims, your honors.

[00:20:59] Speaker 01:
Now, I would like to say that also that the board

[00:21:03] Speaker 01:
Expressly.

[00:21:04] Speaker 04:
I'm sorry, where were you reading from?

[00:21:06] Speaker 04:
I see counsel.

[00:21:07] Speaker 01:
In 829.

[00:21:08] Speaker 04:
Judge Turnquist, I have a follow-up question.

[00:21:10] Speaker 04:
Where in the patent under response do you address the claims?

[00:21:13] Speaker 01:
Yes.

[00:21:13] Speaker 04:
The claims as a whole for written description?

[00:21:15] Speaker 01:
Yes, and then there's a, on the next page, 829 of the appendix.

[00:21:22] Speaker 01:
829?

[00:21:23] Speaker 01:
829, yes.

[00:21:25] Speaker 02:
Okay.

[00:21:29] Speaker 01:
I think it's towards the middle of the page, Your Honor.

[00:21:35] Speaker 01:
It starts regarding Your Honor's questions, regarding whether we laid out our papers.

[00:21:42] Speaker 04:
Well, Counselor, they asked a question, and then there's 26 pages of testimony that you didn't give me, and an ambiguous answer regarding Your Honor's questions regarding whether we laid out in our papers the provisional support for each and every limitation of the claims.

[00:22:01] Speaker 04:
It's not explicitly there.

[00:22:03] Speaker 04:
Each and every limitation, I don't know what limitations they're talking about.

[00:22:07] Speaker 04:
I mean, respectfully, I don't see how that helps you at all.

[00:22:12] Speaker 01:
Yes, there are.

[00:22:15] Speaker 01:
When they first asked the question, opposing counsel said that she would answer this on rebuttal.

[00:22:21] Speaker 01:
And so that's why there is all this intermediate discussion that went on.

[00:22:25] Speaker 01:
And then they asked for written description support of all the claims, and that was the answer.

[00:22:30] Speaker 04:
That doesn't mean that she's admitting that there's no written description support for dodecyl maldecide.

[00:22:38] Speaker 01:
Well, with respect, Your Honor, if they say it's explicitly not there.

[00:22:45] Speaker 01:
I mean, written description.

[00:22:46] Speaker 04:
Who says it's explicitly not there?

[00:22:47] Speaker 01:
If her answer is, with respect to written description of each and every limitation of the claims, it's not explicitly there.

[00:22:54] Speaker 04:
For each and every limitation.

[00:22:55] Speaker 04:
She's not saying no claim limitations are supported.

[00:22:59] Speaker 04:
She says maybe there's some that aren't supported.

[00:23:03] Speaker 04:
When she says each and every limitation, it's not explicitly there.

[00:23:08] Speaker 04:
I'm sorry, but with all due respect, I don't have any clue what limitation she's talking about at that point.

[00:23:13] Speaker 04:
Perhaps the 26 intervening pages would have lent some clarity between the question and the answer you want me to assume is an answer to a particular question.

[00:23:22] Speaker 01:
I understand, Your Honor.

[00:23:24] Speaker 01:
Those pages do not provide any additional information, however.

[00:23:29] Speaker 01:
I do want to state also, however, that the board did expressly address do-delta multicell.

[00:23:40] Speaker 01:
They did this in the appendix, page 19 at the beginning, when they said that after they have incorporated, by reference, the 12-alpaglycoside species, there was no written description

[00:23:54] Speaker 01:
for the 12-alkylglycoside species, which of course includes the species dodecylmalticide.

[00:24:00] Speaker 01:
Now I will also mention that the term alkylglycosides appears nowhere in the SIGMA catalog or in the 558 provisional.

[00:24:08] Speaker 01:
That was the term cobbled together.

[00:24:09] Speaker 04:
The board did not specifically address anywhere the dodecylmalticide, did they?

[00:24:16] Speaker 01:
I think it does because when they address the 12-alpha glycosides, it has to include dodecylmalticide.

[00:24:24] Speaker 01:
And they also addressed it later on when it dealt specifically with the dodecylmalticide-dependent claims.

[00:24:36] Speaker 01:
It had to.

[00:24:37] Speaker 04:
Where is that?

[00:24:37] Speaker 04:
What page can I find that?

[00:24:39] Speaker 01:
One moment, Your Honor.

[00:24:48] Speaker 01:
pages 33 to 35 of the appendix.

[00:25:04] Speaker 04:
And where do you say they address whether or not there's support for the dodecyl melticide?

[00:25:13] Speaker 04:
This looks like it's just articulating the arguments.

[00:25:15] Speaker 04:
Am I missing something?

[00:25:16] Speaker 01:
Yes.

[00:25:17] Speaker 01:
And the appendix on page 19, at the top of that page, they expressly

[00:25:28] Speaker 04:
They expressly talk about dodecyl malteside?

[00:25:30] Speaker 01:
They talk about when they incorporated the 12-alkylglycoside species, once that was incorporated, there was no written description for the 12-alkylglycoside species.

[00:25:47] Speaker 04:
Well, okay, but it's saying there's nothing that leads someone to alkylglycosides in the stigma catalog, but is that

[00:25:58] Speaker 04:
different from whether there's something that leads somebody specifically to dodecyl malticide?

[00:26:04] Speaker 01:
Well, Your Honor, that was just a truncated way of listing the 12 albumglycoside species.

[00:26:12] Speaker 01:
I'm not sure that the board recognized all 12.

[00:26:17] Speaker 01:
They know there's 12 there because our experts recited 12.

[00:26:21] Speaker 01:
But dodecyl malticide certainly is one of the 12 species.

[00:26:25] Speaker 01:
And if they're saying that there's

[00:26:27] Speaker 01:
written description for the 12-alkylglycoside species, that certainly means that there's no written description for each of them, including dodecylmalticide.

[00:26:39] Speaker 04:
So why?

[00:26:39] Speaker 04:
I'm confused.

[00:26:41] Speaker 04:
If this patent had listed 150 compounds right in the specification, wasn't even incorporated by reference, 150 compounds, why doesn't that satisfy the possession requirement?

[00:26:57] Speaker 01:
I don't think it's a question of numbers, Your Honor.

[00:26:59] Speaker 01:
It's a question of whether there's direction enough to show that they had possession.

[00:27:05] Speaker 01:
I think it's instructive to look at the totality of the 558 provisional.

[00:27:11] Speaker 01:
What Norellis is arguing, basically, is that they're focusing on one page of the Sigma catalog, which is six pages.

[00:27:22] Speaker 01:
and to the exclusion of those six pages and all the rest of the enhancer paragraphs in 558.

[00:27:30] Speaker 01:
And if you would like to turn to pages, page eight of the red brief, it's quite instructive because it gives you paragraphs 150 to 152.

[00:27:40] Speaker 01:
There, you can see that there's a discussion of the enhancers.

[00:27:48] Speaker 01:
And in those paragraphs,

[00:27:50] Speaker 01:
there's 15 classes that are provided of enhancers.

[00:27:57] Speaker 01:
And in fact, in paragraph 151, you can see that there are preferences.

[00:28:03] Speaker 01:
Two classes are preferred, the lysophospholipids and the acylcarnitines, with some preferred species of each.

[00:28:12] Speaker 01:
Then as you go down to paragraph 152, you see additional classes that are listed.

[00:28:19] Speaker 01:
One of them is surface active agents.

[00:28:22] Speaker 01:
And in parentheses, it says especially non-ionics.

[00:28:25] Speaker 01:
And then additional listings.

[00:28:27] Speaker 04:
I just have a curiosity.

[00:28:28] Speaker 04:
Since it says surface active agents, especially non-ionic materials, why wouldn't that, as opposing counsel suggested, take you to page 10705 of the SIGMA reference, which is incorporated by reference, which has a category non-ionic

[00:28:47] Speaker 04:
And it lists 10 things, seven of which are alkyl glycosides.

[00:28:52] Speaker 04:
So why wouldn't that show possession to a skilled artisan?

[00:28:58] Speaker 01:
We have two comments to make with respect to that question, Your Honor.

[00:29:02] Speaker 01:
The first is that we have agreeing testimony from experts on both sides that says that the term non-ionics as it relates to surface active agents

[00:29:12] Speaker 01:
is not in any way linked or connected to the class of biological detergents.

[00:29:17] Speaker 01:
And in fact, even a layman looking at it would see that they are distinct classes.

[00:29:22] Speaker 01:
However, the questives expert took this a step further and said, well, what if a pose that was prompted by non-ionics?

[00:29:32] Speaker 01:
Then you go to the Sigma catalog, which was incorporated, all six pages by reference.

[00:29:40] Speaker 01:
And when you see the six pages, and that's helpful to look at, the six pages, not just focus on one, that can be found at 10.705 of the appendix to 10.710.

[00:29:50] Speaker 01:
When you look at the entirety of that, you see that there are four subclasses, anionics, cationics, zwitterionics, and nonionics.

[00:30:00] Speaker 01:
And the questions experts said, even if you oppose it, we're prompted by non-ionics.

[00:30:05] Speaker 01:
There's 150 biological detergents that you have to sift through.

[00:30:10] Speaker 01:
And then when you get to the non-ionic class, there's 100 non-ionics there, 100 non-ionics, among which there are sprinkle 12-alkylglycoside species.

[00:30:20] Speaker 01:
Again, the term alkylglycosides was in the claims, but it's nowhere to be found in any of the SIGMA catalog or the 558 provisional.

[00:30:30] Speaker 01:
That was cobbled together in order to make a class of alkylglycosides.

[00:30:34] Speaker 01:
But there's testimony from Dr. Wermeling that says that nothing points to, nothing provides direction, and it's not immediately discernible that you would know that apoglycosides or dodecylmaltoside is part of the invention by going to this catalog, this pricing catalog.

[00:30:56] Speaker 04:
So is part of the invention not every one of these 150?

[00:31:01] Speaker 01:
What we know is that

[00:31:04] Speaker 01:
There are some preferred ones, and we can certainly say those are part of the invention.

[00:31:10] Speaker 01:
But what we also know is that there's substantial evidence that points to lack of written description with respect to alpha glycosides and the species dodecyl malticide.

[00:31:22] Speaker 04:
Even though dodecyl malticide is expressly listed as one of the 150?

[00:31:27] Speaker 01:
Yes, Your Honor, the mere recitation is insufficient.

[00:31:31] Speaker 01:
Unless there's something that shows that the inventor had possession at the time, there's got to be some direction to that species, not just the recitation.

[00:31:40] Speaker 01:
And that's what the board said.

[00:31:41] Speaker 01:
The board relied on the incorporation of those 12 species and then said, notwithstanding the recitation, there was substantial evidence that a person of ordinary skill in the art would not know that alkylglycosides or dodecymaltoside was part of the invention.

[00:31:58] Speaker 04:
What was that substantial evidence?

[00:32:01] Speaker 04:
A lot of times in cases like this, you have literally hundreds upon hundreds of hundreds of possibilities, and it turns out only a couple of them worked, and there wasn't evidence showing you men are possessed those particular ones.

[00:32:15] Speaker 04:
In the Juneau case, it was literally billions.

[00:32:18] Speaker 04:
Here, we're talking about a list of 150, and I have no idea how many work, but they're claiming 12.

[00:32:25] Speaker 04:
If you were to look at page one of the reference,

[00:32:28] Speaker 04:
7 of 10 under the header non-inomic are included.

[00:32:31] Speaker 04:
How do we know?

[00:32:33] Speaker 04:
What is the evidence at the board?

[00:32:34] Speaker 04:
It's a fact question, so what specifically is the substantial evidence?

[00:32:38] Speaker 04:
that supports the board's finding that this disclosure wouldn't have led a skilled artisan to appreciate that this inventor possessed alcohol glycosides in particular.

[00:32:49] Speaker 01:
Yes, but the board relied on the testimony of a questions expert, which said that Opposa, even being directed to this class of non-ionics in the Sigma catalog, still would not know which non-ionic to select, because there's simply no direction

[00:33:07] Speaker 01:
as to which of these species would work, which is important.

[00:33:11] Speaker 01:
Did the inventor include all of these 150 biological detergents?

[00:33:16] Speaker 01:
I mean, after all, this is a pharmaceutical which is intended to go into the body.

[00:33:20] Speaker 01:
We don't know which ones work.

[00:33:22] Speaker 01:
And there's just simply no direction, no blaze marks that points to dodecymaltisol among 150 biological detergents.

[00:33:32] Speaker 01:
And then the substantial evidence was that this testimony of Dr. Wormley

[00:33:36] Speaker 01:
who is a questives expert, and upon which the board properly relied.

[00:33:41] Speaker 00:
Counsel, it seems to me that your friend on the other side is arguing that the manner in which the reference is categorized and the categorization of the different non-ionic detergents that are listed here is a sufficient blaze mark.

[00:33:59] Speaker 00:
What's your response to that?

[00:34:01] Speaker 01:
Well, we know from the testimony of Equestib's expert that even given that as a blaze mark, he even posed that as a blaze mark.

[00:34:10] Speaker 01:
If that were to prompt someone who is a posa to go to the sigma catalog and look under non-ionics, still no direction as to which one points to dodecylmalticide.

[00:34:21] Speaker 01:
And there is no alpha-glycoside class to point to.

[00:34:24] Speaker 01:
There's no sub-sub class.

[00:34:30] Speaker 04:
Okay, Council, I think your time is up.

[00:34:33] Speaker 01:
Thank you, Your Honor.

[00:34:34] Speaker 01:
Any further, I would press on the briefs if there's any further.

[00:34:37] Speaker 01:
Thank you.

[00:34:38] Speaker 04:
Ms.

[00:34:38] Speaker 04:
Devine will give you two minutes of rebuttal time.

[00:34:48] Speaker 03:
Thank you, Your Honor.

[00:34:49] Speaker 03:
I appreciate it.

[00:34:49] Speaker 03:
I will be brief.

[00:34:51] Speaker 03:
A couple of notes.

[00:34:52] Speaker 03:
The enablement argument, whether it would work, and the consisting of argument were not raised below.

[00:34:59] Speaker 03:
Those are new arguments raised by petitioner in their briefing here.

[00:35:03] Speaker 03:
and we would submit that under Bivings v. U.S.

[00:35:05] Speaker 03:
Department of Agriculture, that's 205 F3 1331 Federal Circuit 2002, this court cannot affirm based on an argument that was not raised below.

[00:35:18] Speaker 03:
The second point I'd like to make is that

[00:35:22] Speaker 03:
My friend on the other side continues to espouse a preference argument, and it is not a preference for dodecylmalticide that must be shown in order to show possession.

[00:35:33] Speaker 03:
And there is no evidence of record that says that a person of skill in the art opening the specification and seeing the words dodecylmalticide

[00:35:41] Speaker 03:
would not readily understand that the inventor was in possession of dodecylmalticide as stated there.

[00:35:48] Speaker 02:
So just to be clear, you're arguing that the species would be separately patentable whether or not the reference is prior art listing the 150?

[00:36:01] Speaker 03:
Let me clarify, Your Honor.

[00:36:02] Speaker 03:
So we're arguing that the species is patentable because the specification discloses the species.

[00:36:08] Speaker 03:
The reference Watts that was the basis for all of the obviousness findings, if we are entitled to that priority date, is not prior art.

[00:36:18] Speaker 03:
So the obviousness findings cannot stand so long as we are entitled to that priority date, which we are entitled to, at least with respect to the Doe Dessel Multicide Claims, which are literally supported in the provisional application.

[00:36:32] Speaker 03:
Did that answer your question, Your Honor?

[00:36:35] Speaker 02:
Well, I really was hoping to draw

[00:36:37] Speaker 02:
More precise line, when I said whether or not they're entitled to the filing date, the provisional date.

[00:36:46] Speaker 03:
So the support is in the provisional, so we would need to be entitled to the provisional date, which we are.

[00:36:53] Speaker 03:
And I see that my time is up.

[00:36:55] Speaker 04:
OK, thanks.

[00:36:56] Speaker 04:
Both counsel, this case is taken under submission.