[00:00:00] Speaker 04:
Our next case is Sage Products, LLC versus Brent.

[00:00:04] Speaker 04:
Docket number 23-60-03.

[00:00:06] Speaker 04:
Councillor Franzen, did I pronounce your name correctly?

[00:00:13] Speaker 04:
Yes, sir.

[00:00:13] Speaker 04:
Okay.

[00:00:14] Speaker 04:
And you have three minutes reserved for rebuttal.

[00:00:16] Speaker 04:
Is that correct?

[00:00:17] Speaker 04:
Yes, sir.

[00:00:18] Speaker 04:
Okay.

[00:00:19] Speaker 04:
We're ready when you are.

[00:00:22] Speaker 03:
May it please the court, Sandra Franzen, on behalf of the appellant, Director Sage Products.

[00:00:29] Speaker 03:
The panel trial and appeal board committed legal error by repeatedly exceeding its authority in the two underlying IPRs, violating the APA.

[00:00:38] Speaker 03:
For each of the three grounds, the board either disregarded or even outright rejected the petitioner's arguments, the grounds that were actually articulated in the petition, and found the claims unpatentable under their own grounds.

[00:00:52] Speaker 03:
As the Supreme Court has in the SAS case, it's the petition, not the director of the PTO, that governs the proceedings of an IPR.

[00:01:03] Speaker 03:
So the board did legally err when it made up its own grounds.

[00:01:07] Speaker 03:
And let me start with ground one, the independent claims, because on that particular ground, the final run decision actually rejected the petitioned argument, agreed with us, yet we still somehow lost that ground.

[00:01:22] Speaker 03:
So...

[00:01:24] Speaker 03:
And those errors in ground one permeate and are incorporated into all the other grounds.

[00:01:29] Speaker 03:
So in ground one, the petitioner's argument was relatively simple.

[00:01:32] Speaker 03:
Ground one was presented as a pure claim construction argument where the petitioner lodged the independent claims were anticipated by the PAR, the UK Public Assessment Report, because the term sterilized, whether a sterilized product, article, or composition, simply meant being in a sterile condition.

[00:01:54] Speaker 03:
They basically said PARR anticipates because the road sterile means that it's sterilized and that's all that's reported by the claims.

[00:02:03] Speaker 03:
The position never argued that the PARR disclosed that any product article composition had been sterilized or was subjected to validated sterility processing.

[00:02:16] Speaker 03:
It was just not relevant to the Gwangan argument.

[00:02:19] Speaker 03:
Now, in response to that petitioned argument, SAGE sent pages arguing why sterilized and sterile were two different terms.

[00:02:28] Speaker 03:
And that wrote that they were not the same.

[00:02:30] Speaker 03:
In our argument, we argued that validated sterility processing was required, consistent with the spec.

[00:02:38] Speaker 01:
Do you also know that ecoviral application is used to ensure the content of the package will remain sterile?

[00:02:47] Speaker 03:
Pardon me, I didn't hear the first part of your question.

[00:02:49] Speaker 03:
I think that the record evidence did say that there was evidence in the record that that was something about ethyl vinyl acetate, but there was nothing in the PAR that said that the ethyl vinyl acetate had been terminally sterilized.

[00:03:17] Speaker 03:
And in round one in particular, they never argued that it had to be sterilized.

[00:03:22] Speaker 03:
That was not their argument.

[00:03:24] Speaker 03:
And it was a claim construction argument.

[00:03:27] Speaker 03:
And Sage won that argument in the final ring decision.

[00:03:30] Speaker 03:
The board adopted our claim.

[00:03:31] Speaker 00:
Because I understand what happened here.

[00:03:33] Speaker 00:
The petition said, in the PAR, the word sterile would be understood by one of skill in the art.

[00:03:41] Speaker 00:
to mean sterilized, consistent with the clay construction through a process, et cetera, et cetera.

[00:03:48] Speaker 00:
And you disputed that, and the board made a fact finding as to what one of Skilmy Art would read into the word sterile in the context of the UK park.

[00:04:00] Speaker 00:
Isn't that what happened?

[00:04:02] Speaker 03:
Your honor, I disagree with that.

[00:04:03] Speaker 03:
In ground one, they presented it under their claim construction that sterile meant in a sterile condition and not subject to sterility processing.

[00:04:12] Speaker 03:
In ground two and three, they presented it under our claim construction.

[00:04:16] Speaker 00:
But once the board and the institution decision had an initial construction, the petitioners allowed to try to prove anticipation under the board's

[00:04:27] Speaker 00:
initial and instituted construction, are they not?

[00:04:31] Speaker 03:
Well, Your Honor, I think the way that was presented was that they proved obviousness based on, or they tried to prove obviousness based on power loan under the board's construction in ground two.

[00:04:42] Speaker 03:
Obviousness.

[00:04:43] Speaker 00:
They tried to prove anticipation under the board's construction in ground one.

[00:04:48] Speaker 03:
They did that after the fact.

[00:04:50] Speaker 00:
In their original petition, they presented ground one as a claim construction under their... Again, are you saying we have case law that says if the petitioner's proposed construction is not accepted, they per se lose on that ground?

[00:05:07] Speaker 03:
I'm not saying that that's a general rule.

[00:05:09] Speaker 03:
I'm just saying for this particular petition, how it was presented was anticipation under their construction in ground one and obviousness under our construction in ground two.

[00:05:19] Speaker 03:
And with regard to ground one, the petitioner never argued and the petitioner never argued in the independent claims that the UK standards were relevant at all.

[00:05:31] Speaker 03:
It was just never brought up.

[00:05:33] Speaker 03:
They just said the word sterile means sterilized.

[00:05:36] Speaker 03:
And in ground two, they did argue that the UK standards, a person would understand and it would render obvious that under all construction, but that was their ground two argument, obviousness.

[00:05:50] Speaker 03:
They basically implicitly conceded that it was not anticipated under their construction, which was ground one.

[00:05:59] Speaker 03:
In our view, we should have won ground one as we actually did in the institution decision.

[00:06:04] Speaker 03:
The board in the institution decision found in our favor that sterile didn't mean sterilized.

[00:06:10] Speaker 03:
It meant sterilized as we define the term, not as BD did.

[00:06:14] Speaker 03:
But then what happened was that's not what happened in the final written decision.

[00:06:20] Speaker 03:
Instead, the board invented two new theories in the final written decision to find the independent claims anticipated.

[00:06:29] Speaker 03:
And the first new theory, which was never presented in the petition, was that posers, by definition, would understand the term sterile to, they would know that the UK, they would know the UK regulatory standards for the UK.

[00:06:43] Speaker 04:
And your main objection is the definition for the up-person ordinary skill in this case.

[00:06:49] Speaker 03:
That is a major objection because that definition where they incorporated knowledge of right

[00:06:56] Speaker 03:
standards the UK chloro-pep product is subject to, permeated as all the grounds.

[00:07:02] Speaker 04:
For example, you argue that a person with an ordinary skill would not be aware of the UK regulations concerning sterilize and sterile, the difference in those terms.

[00:07:13] Speaker 03:
I think that we more pointedly argued that the persons on their scale on the art did not know that the UK regulatory standards as they applied to the chloro-prep product.

[00:07:27] Speaker 03:
And recall at the time there was

[00:07:31] Speaker 03:
I'm certainly in the area because antiseptics are sterile.

[00:07:37] Speaker 01:
They're sterilizing.

[00:07:40] Speaker 01:
What are you saying though that a person of ordinary skin would generally know about the UK standards?

[00:07:43] Speaker 01:
Are you admitting that?

[00:07:44] Speaker 03:
Yeah, you would know about standards generally, and I think people knew about standards.

[00:07:48] Speaker 01:
So that's not the issue.

[00:07:50] Speaker 01:
But you're talking about the UK standards, right?

[00:07:51] Speaker 03:
Even the UK had standards that were similar to the FDA standards.

[00:07:55] Speaker 03:
It's just that

[00:07:57] Speaker 03:
There was more knowledge in the art and no POSA that actually knew that, for example, UK standards were used to sterilize chlorhexidine products, and the UK standards never mentioned sterilizing chlorhexidine products.

[00:08:12] Speaker 03:
That was something that was never shown anywhere.

[00:08:15] Speaker 03:
Just the two employees said that those standards applied.

[00:08:18] Speaker 00:
The board considered all of the evidence on these points and disagreed with you.

[00:08:22] Speaker 00:
They said, first of all,

[00:08:24] Speaker 00:
And you saying no person of skill in the art said these things, that's rejecting their expert, who the board specifically said would be a person of skill in the art, and that you never moved to exclude them.

[00:08:36] Speaker 00:
So it just seems like all of this is substantial evidence questions.

[00:08:40] Speaker 00:
And I understand the procedural arguments, but putting them aside, it seems like there's substantial evidence to support what the board found on all of these disputes you're raising.

[00:08:50] Speaker 03:
Well, I do think the clear legal error in the board going off the rails with its own theories using a new person of ordinary scale standard, and they also made up this terminal sterilization theory standard with the ethylene oxide, which was just a completely new theory in ground one.

[00:09:08] Speaker 03:
I do think that was a clear legal error because it was on the petition.

[00:09:12] Speaker 04:
What do you mean by a new standard for a person of ordinary scale?

[00:09:15] Speaker 04:
You're arguing that the board established a whole new standard for a person of ordinary

[00:09:20] Speaker 04:
personal or no skill or that the definition that the board ascribed to a personal or no skill in this case was there.

[00:09:28] Speaker 03:
Yes.

[00:09:28] Speaker 03:
Yes.

[00:09:29] Speaker 04:
The ladder.

[00:09:30] Speaker 03:
The ladder.

[00:09:31] Speaker 00:
So I understood they adopted your proposed construction of a person of skill in the art.

[00:09:36] Speaker 03:
They did adopt our construction.

[00:09:39] Speaker 03:
However, when they actually applied the term, they required the personnel of Ordinary Skilled in the Art to have knowledge of the UK standards, specifically the 556 standard, as it applied to the chloro-prep product.

[00:09:56] Speaker 00:
They made a finding that under your definition of person skilled in the art, having four years of experience, which was something your expert added to the definition,

[00:10:05] Speaker 00:
So not in dispute by you that that person would know of these UK standards and would know how they differ from the US standards.

[00:10:13] Speaker 00:
So finding a fact that they made about what a person of skill in the art who you defined would know, I don't see what's wrong with that.

[00:10:20] Speaker 03:
Well, the way that you're framing it, it does sound reasonable, but it's the specific point, not just, did they know about UK standards, like the UK has standards.

[00:10:30] Speaker 03:
It's how the standards apply to chloroprep in particular.

[00:10:35] Speaker 03:
Chloroprep, the medicinal product, the antiseptic, chlorhexidine products.

[00:10:40] Speaker 01:
There was, there was, there actually... Didn't the invader of the fiscal 2010 actually admit to having four double zero arms?

[00:10:49] Speaker 03:
There was testimony on the record that they had heard of it, but no one knew about the sterility processing.

[00:10:58] Speaker 03:
So it was kind of consistent with no one knew how to sterilize CHE at the FDA hearings.

[00:11:06] Speaker 03:
And telling Lee, Becton Dickinson was at the FDA hearings and didn't say, hey, we're manufacturing a sterilized product in Europe.

[00:11:15] Speaker 03:
No one knew about a sterilized product.

[00:11:17] Speaker 03:
At the time, everyone thought it was impossible.

[00:11:20] Speaker 03:
And kind of, more importantly, how it applied to chloroplasts in particular

[00:11:26] Speaker 03:
in the UK was not something even persons of ordinary stormy art knew about.

[00:11:31] Speaker 03:
Their expert in particular had no experience of chlorprop prior to the case.

[00:11:35] Speaker 03:
He did not know about the standards at the time.

[00:11:38] Speaker 03:
So, and our expert, who was an expert on chlorhexidine, didn't know about it either.

[00:11:44] Speaker 03:
The only two people that were able to get up and say that the 556 standard supposedly applied to ChloroPrep were their two employees that had confidential information in their possession.

[00:11:55] Speaker 01:
So by what... I know a lot of data that goes through some, I think they're defending the judge's trust, but I thought that there was something actually in the decision making that sort of finding.

[00:12:08] Speaker 01:
Isn't that on, is it Appendix 41?

[00:12:17] Speaker 03:
I apologize, Your Honor.

[00:12:27] Speaker 01:
Making the finding that... I think one of the final written decisions takes the threat off the page that I was talking about in terms of knowledge about the curative afterwards, and in particular, what was going on with the POC project.

[00:12:45] Speaker 01:
And I thought that was actually a decision made by the board.

[00:12:47] Speaker 01:
for that.

[00:12:53] Speaker 03:
I'm looking at page 41, Your Honor.

[00:12:56] Speaker 00:
How about this at 42?

[00:12:57] Speaker 00:
We find it implausible that someone with four years of experience with sterilization processes for medical products and their components would lack familiarity with regulatory regimes that set the conditions under which those products work.

[00:13:10] Speaker 03:
Yes, and I started that.

[00:13:11] Speaker 00:
Because no one argued that that was a, to the definition... Is there not substantial evidence to support that finding after considering all the evidence on both sides?

[00:13:22] Speaker 03:
Your Honor, the finding of how it would apply to a UK chloro-prep product, no, there's not.

[00:13:27] Speaker 03:
The only people that were able to say how it would apply to the UK chloro-prep product, and then, remember, we're talking about a prior document, the PAR, not the product itself.

[00:13:38] Speaker 03:
This is a document and how a person of ordinary skill would view that.

[00:13:43] Speaker 03:
Their expert in particular had no prior experience with the UK chloro-prep.

[00:13:48] Speaker 03:
the first time he knew about it was the case.

[00:13:51] Speaker 03:
That's why in reply they brought in their two employees and that was beyond the scope of what ground one was to begin with.

[00:14:00] Speaker 03:
So those UK standards which were never argued as relevant to ground one in the independent claims

[00:14:07] Speaker 03:
were imported and basically modified the par, which said nothing about the UK standard, which said nothing about sterilizing the product.

[00:14:17] Speaker 03:
And basically, all this disclosure was being imported to beef up the par.

[00:14:24] Speaker 04:
OK.

[00:14:25] Speaker 04:
You're into rebuttal time.

[00:14:28] Speaker 04:
Oh, OK.

[00:14:30] Speaker 04:
Any questions?

[00:14:37] Speaker 03:
Thank you.

[00:14:45] Speaker 04:
Yes.

[00:14:50] Speaker 04:
Council, your last name is pronounced Wynne or Wynne?

[00:14:54] Speaker 02:
It could be either, depending on where you are, Your Honor, but in the U.S.

[00:14:58] Speaker 02:
I go by Wynne.

[00:14:59] Speaker 02:
Okay.

[00:15:04] Speaker 02:
Good morning, Your Honors, and may it please the Court.

[00:15:09] Speaker 02:
The board correctly found the challenge claims of Sage's patents unpatentable based on three separate grounds.

[00:15:15] Speaker 02:
Now, this court would only agree with the board's conclusion on one ground to affirm, but here it can affirm on all three, because substantial evidence supports the board's findings that the UKCLAW of the PAR document discloses every element of the challenge claims,

[00:15:30] Speaker 02:
that the term STER in a regulatory document such as the PAR would have had a specific meaning to a personal skill in the art, and in any event, a personal skill in the art would have been motivated to combine the PAR with the DAGALA reference with a reasonable expectation of success.

[00:15:45] Speaker 04:
So what's your best argument to the argument that the other side is making that a person of ordinary skill in the art would have been aware of the sterilization requirements under UK regulations?

[00:15:57] Speaker 02:
So Your Honor, the Board looked to, and within my answer, I'd like to address a little bit of counsel's arguments about ground one independent claims not including the reference to the standard.

[00:16:10] Speaker 02:
So the Board looked to the petition ground, which for claim one, referenced the testimony of Dr. Dabba, who said that validation and certification would be required by UCARE regulatory authorities.

[00:16:23] Speaker 02:
and for the product part of the claim, and then for the composition part of the claim, reference module five of the PAR, which again talks about validation of manufacturing.

[00:16:35] Speaker 02:
And said, the petition said, this further confirms the validated sterility of the device and the solution.

[00:16:43] Speaker 02:
The board looked to the disclosures of the PAR and looked to the testimony of Dr. Daba to conclude that

[00:16:51] Speaker 02:
and Dr. Daba's testimony that using the term sterile in a regulatory approval document means something and means sterilized as construed here.

[00:17:02] Speaker 02:
So where the specific UK standard comes in was through the dependent claims, and the board considered all of this evidence together.

[00:17:12] Speaker 02:
Again, for that specific UK standard, the board credited the testimony of Dr. Daba.

[00:17:18] Speaker 04:
Let me ask the question a different way.

[00:17:21] Speaker 04:
Shouldn't the board have included in the definition of a person of ordinary skill knowledge of foreign-based regulatory standards?

[00:17:35] Speaker 04:
Where are we being led to here as to what a person of ordinary skill and knowledge should know?

[00:17:41] Speaker 04:
There seems to be a leap here, and I want to know if that leap is substantiated.

[00:17:47] Speaker 02:
So this goes back to the discussion you were having with council about the definition of personal skill in art with which Sage's expert agreed.

[00:17:56] Speaker 02:
And in fact, the requirement that this person have four years of relevant experience was proposed by Sage's expert and the board adopted that.

[00:18:05] Speaker 02:
And the board made the finding that someone with four years of experience in the relevant space would understand

[00:18:15] Speaker 02:
the regulations that would apply.

[00:18:20] Speaker 00:
But if that is something a person of ordinary skill and the art would know, shouldn't that be accounted for in the actual definition of who the person of ordinary skill and the art is?

[00:18:33] Speaker 00:
And if not, doesn't this create a hole in which the board could potentially pour a lot of substance by simply saying, oh, it's something one of skill and the art would know?

[00:18:43] Speaker 02:
So I disagree with that characterization, Your Honor, because we have to think about how this debate about UK standard versus US standard came into the proceeding.

[00:18:53] Speaker 02:
The board made its finding about what a personal skill in the art would have known.

[00:18:57] Speaker 02:
And then Sage argued that the term sterile would have a questionable meaning based on what was happening in the U.S.

[00:19:06] Speaker 02:
There was evidence in the record that in the U.K.

[00:19:09] Speaker 02:
a different standard would apply, that in the U.K.

[00:19:12] Speaker 02:
sterilization was in fact required.

[00:19:15] Speaker 02:
And those were the arguments that the board was responding to when it made its finding that knowledge of U.K.

[00:19:21] Speaker 02:
versus U.S.

[00:19:22] Speaker 02:
would be within

[00:19:23] Speaker 02:
This would be within the knowledge of a person of skill in the art.

[00:19:29] Speaker 04:
And again, as to... And then based that definition on the rest of the testimony of Dr. Daba, right?

[00:19:39] Speaker 02:
So the board made the definition based on... Sage didn't propose a definition.

[00:19:48] Speaker 02:
The board in the institution decision

[00:19:53] Speaker 02:
came up with the definition, and Sage's expert agreed with that.

[00:19:57] Speaker 02:
And then in the final written decision, the board added Sage's expert's comment that four years of relevant experience would be required.

[00:20:14] Speaker 02:
Yes, Your Honor.

[00:20:15] Speaker 02:
And so you can see the board's findings regarding Dr. Daba specifically on Appendix 18.

[00:20:22] Speaker 02:
The board properly found that Dr. Daba had four years of experience with sterilization processes for medical products, that he had familiarity with antiseptics, that he was involved in steam and ethanol oxide sterilization for several products, including medical devices, and credited his educational background and his familiarity with antiseptics.

[00:20:45] Speaker 02:
I'm so glad this is the fact finding.

[00:20:46] Speaker 02:
I'm that that's it is now disagreeing with.

[00:20:50] Speaker 02:
But the board did consider Dr. Dapa and credited him his experience and credited him as the as an expert whose testimony would be credited.

[00:21:00] Speaker 00:
On ground one I believe Ms.

[00:21:02] Speaker 00:
Franzen told us that the petition only sought.

[00:21:08] Speaker 00:
Invalidation based on anticipation under the

[00:21:19] Speaker 00:
of anticipation under any other construction.

[00:21:22] Speaker 00:
Is that incorrect?

[00:21:23] Speaker 02:
I wouldn't agree with that, Your Honor, and that's because if you look to the petition, the arguments made at Appendix 604.3 to 405, it references Dr. Dabe's testimony, who talks about validation and certification that was required.

[00:21:39] Speaker 02:
Again, at 6045 to 46, it references confirming the validated sterility of the device and the solution.

[00:21:48] Speaker 02:
So the petition did argue for the independent claims that the UK regulatory requirements apply.

[00:21:55] Speaker 02:
Yes, for the dependent claim it talked about a specific standard, and that's because the dependent claims require a specific sterility level.

[00:22:02] Speaker 02:
So I don't believe that the petition cut itself off.

[00:22:07] Speaker 02:
And in fact, I agree with the question you were posing to Sage's counsel.

[00:22:15] Speaker 02:
The petitioner here attempted to prove anticipation under the board's construction, and the board...

[00:22:31] Speaker 01:
I'll try to speak up a little bit.

[00:22:48] Speaker 02:
Is that better?

[00:22:55] Speaker 02:
So remind me of your question, Your Honor.

[00:22:57] Speaker 02:
I apologize.

[00:22:59] Speaker 01:
So I think Sage's argument, in decent part, is that what's going on here is the board's anticipation determination is based on some documents from the other side of the petition.

[00:23:12] Speaker 01:
I felt like when I was listening to Sage, it was arguing that there were basically some arguments that would be made effectively based on documents from one of the petitions.

[00:23:24] Speaker 02:
So I think at least as to ground one, which I believe is what your question is about, the board looked to Dr. Daba's testimony and the British standard.

[00:23:41] Speaker 02:
And those were both sided, obviously, with the petition.

[00:23:46] Speaker 02:
There was testimony

[00:23:49] Speaker 02:
presented in the reply to counter Sage's specific argument that there's no way this standard could have applied.

[00:23:59] Speaker 02:
And again, the board's findings didn't depend entirely on those witness testimony or those witness declaration that were

[00:24:07] Speaker 02:
presented with the reply, the board looked at all of the evidence and crediting Dr. Dabba, crediting the British standard, concluded that compliance was required with the British standard and looking to Dr. Dabba's, again, presented with the petition, concluded that the use of the term sterile in the strict regulatory context such as the PAR is a term with a precise meaning.

[00:24:32] Speaker 01:
I think they should also argue that the board is somehow

[00:24:36] Speaker 01:
adopting arguments on behalf of the petitioner.

[00:24:40] Speaker 01:
What is your response to that?

[00:24:43] Speaker 02:
And I think that goes back to the point I was making earlier, Your Honor.

[00:24:46] Speaker 02:
It's not that the board is adopting arguments on behalf of petitioner.

[00:24:50] Speaker 02:
There's 100 pages of analysis in the board's decision where the board goes through step by step every argument made by SAGE in response to the petition and makes fact findings based on all of the evidence presented.

[00:25:06] Speaker 02:
So if you have a specific question about a specific finding, I'm happy to.

[00:25:11] Speaker 00:
I'll have a specific follow-up.

[00:25:13] Speaker 00:
How about these two declarations from the Bechtin employees and the emails that they're attaching to that?

[00:25:24] Speaker 00:
None of that, I think, is in the petition.

[00:25:26] Speaker 00:
What allows the board in an IPR on anticipation, which should be very narrowly focused, what allows the board to rely on that type of evidence to find anticipation in an IPR?

[00:25:41] Speaker 02:
So two points, Your Honor.

[00:25:43] Speaker 02:
The way the declarations came into the proceedings was because SAGE was contesting that the standard applied at all.

[00:25:53] Speaker 02:
And then second, the board did not base its decision on anticipation solely on

[00:25:59] Speaker 02:
that witness declaration testimony.

[00:26:02] Speaker 02:
It credited Dr. Daba and looked at this.

[00:26:04] Speaker 00:
Certainly not solely, but if it was error, and maybe you don't concede it was error, but if it was error to put any weight on that evidence which was not in the petition,

[00:26:14] Speaker 00:
Wouldn't we have to remand at that point?

[00:26:17] Speaker 02:
No, Your Honor, and if it was error, then it would be harmless error, because again, with just the Dr. Daba's testimony and the standard itself, there is substantial evidence for the board's findings here that a personal ordinary skill in the art would understand the term sterile as used in the plot to mean sterilized as construed.

[00:26:37] Speaker 02:
And that's what we're looking at here.

[00:26:39] Speaker 02:
There's a lot of back and forth in the board's decision because it goes through and addresses each of Sage's arguments, but ultimately the board's conclusion is that the term sterile would mean sterilized to a personal skill in the art.

[00:26:55] Speaker 01:
And it's part of your argument also that if we agree with the board's primary cleaning grant, we wouldn't have to remand because we don't agree with the picture of all grants.

[00:27:06] Speaker 02:
That's correct, Your Honor, because every single ground resolves each of the claims that are challenged.

[00:27:12] Speaker 00:
Can you talk for a second about the confidential nature, though, of that employee evidence?

[00:27:17] Speaker 00:
That would not be prior art, correct, what was just secretly known within Becton Dickinson?

[00:27:23] Speaker 02:
That's correct, Your Honor.

[00:27:24] Speaker 02:
The declarations talked about which standards apply to the product, and some of that information was confidential.

[00:27:34] Speaker 02:
The declarations also talked about how

[00:27:39] Speaker 02:
that was publicizing that there was a difference between the U.K.

[00:27:43] Speaker 02:
and U.S.

[00:27:43] Speaker 02:
product.

[00:27:44] Speaker 02:
Some of that may have been public.

[00:27:46] Speaker 02:
But again, the board's decision does not rest on those two declarations.

[00:27:52] Speaker 02:
The board credited Dr. Daba and the standard and the disclosures of the par itself and resolved all of the factual disputes in petitioner's favor here.

[00:28:05] Speaker 04:
Okay, anything else?

[00:28:07] Speaker 02:
Unless there are any further questions?

[00:28:08] Speaker 04:
Okay, we're fine, thank you.

[00:28:11] Speaker 04:
Thank you, owner.

[00:28:17] Speaker 04:
You have three minutes to rebuttal.

[00:28:23] Speaker 03:
Just a couple of quick points.

[00:28:25] Speaker 03:
One, I really want to make the point that it is not accurate.

[00:28:29] Speaker 03:
The petition did not argue in the independent claims and I ask that you look at the record appendix 6043 to 46 that any standards were relevant to invalidity under ground one in the independent claims.

[00:28:46] Speaker 03:
They just didn't argue it.

[00:28:47] Speaker 03:
They said the word sterile was enough to understand it and that sterilized it.

[00:28:51] Speaker 00:
But then you created a fact dispute which they have a right to respond to and the board has a right to make a finding out, correct?

[00:28:58] Speaker 03:
I don't believe we created a fact dispute.

[00:29:00] Speaker 03:
We said there was no anticipation because that claim construction didn't apply.

[00:29:05] Speaker 03:
So ground one, no anticipation.

[00:29:07] Speaker 03:
In ground two, there was an argument of obviousness based on the UK standards because they only alleged obviousness under our construction.

[00:29:17] Speaker 03:
So the board should have denied ground one and moved to ground two and addressed their obviousness argument under our construction.

[00:29:26] Speaker 03:
I don't believe we created a fact dispute.

[00:29:28] Speaker 03:
We said there was no anticipation under the correct construction, move on to ground two.

[00:29:32] Speaker 03:
The other point I just want to make about the standards

[00:29:37] Speaker 03:
The existence of standards that define whether a medical device is sterile or not.

[00:29:43] Speaker 03:
Those standards exist in the UK with, for example, the 556 that they submitted, but they also exist in the US.

[00:29:50] Speaker 03:
There's standards, and they're on the record, 11137, that say define what sterile is in the US.

[00:29:58] Speaker 03:
They're very similar.

[00:30:00] Speaker 03:
That doesn't mean, just because a standard exists,

[00:30:03] Speaker 03:
both in the U.S.

[00:30:04] Speaker 03:
and the U.K., that a person with a preliminary skill in the art knows that chlorhexidine has been sterilized according to that standard.

[00:30:14] Speaker 03:
And that's where I think the distinction and where the anticipation decision was clearly wrong.

[00:30:21] Speaker 03:
Because what the board did was there was literally no evidence that a

[00:30:26] Speaker 03:
chlorhexidine product had been sterilized under a validated procedure in the PAR itself.

[00:30:32] Speaker 03:
And what the board did was it changed the definition of person of primary skill to have all this side knowledge to expand what was in the PAR.

[00:30:42] Speaker 03:
And the existence of a sterility definition in a standard, just like there was at the FDA,

[00:30:49] Speaker 03:
here in the U.S., just like there was in the U.K., does not mean that it was actually sterilized.

[00:30:55] Speaker 03:
In fact, we presented evidence that in the U.S., despite the word sterile being used on chloroprep documents, a regulatory document and having FDA regulations that say sterile, it wasn't sterilized.

[00:31:10] Speaker 03:
So, the Beatty's employees' personal knowledge about that is

[00:31:15] Speaker 03:
I also just want to quickly make a point that the colorant claims and the sterility assurance level claims, there was no evidence of the record of any sterilized colorant or any SAL of a product or article, not a solution, but a product or article comprising a solution in the prior art.

[00:31:37] Speaker 03:
Those were all items that the board made up as part of its grounds that it just invented on its own to fill in the gaps for the petitioner

[00:31:45] Speaker 03:
that I just got from knowledge in the art.

[00:31:48] Speaker 03:
And the POSA definition isn't the place to backdoor all the information that's missing from the art.

[00:31:58] Speaker 03:
So in conclusion, we request that the decisions be reversed.

[00:32:03] Speaker 04:
Thank you, counselor.

[00:32:05] Speaker 04:
We have the arguments of the party.

[00:32:07] Speaker 04:
We thank you for the arguments.