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The United States Court of Appeals for the Federal Circuit is now open and in session.

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God save the United States and this honorable court.

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The first case for argument this morning is 191513, Pfizer versus 2Guy Pharmaceuticals.

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We're ready to proceed, Counsel, when you are.

[00:00:22] Speaker 00:
Good morning, Your Honors, and may it please the court.

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This is an appeal from a decision of the Patent Trial and Appeal Board finding that

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Shadel, the only prior reference at issue below, did not meet the molarity limitation in the challenged claims.

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This court should reverse the board's construction of the term molarity and vacate the board's decision which upheld the two patents challenged over the Shadel reference.

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I'd like to start first by addressing standing in the case and then I will turn to the merits.

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Thank you, Your Honor.

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Pfizer has standing in this case and to bring this appeal.

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Pfizer has suffered an injury in fact because there's a substantial risk that ChuGuy will bring an action for patent infringement for a product that Pfizer launched earlier this year.

[00:01:20] Speaker 02:
But you have to establish standing at the time you commenced the appeal.

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That is presumably when you file the notice of appeal.

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And in reading your affidavit, I don't see that that issue is addressed.

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Thank you, Your Honor.

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Standing was self-evident at the time the appeal was initiated.

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The parties here are competitors.

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The ChuGuy, the petitioner, excuse me, the ChuGuy, the patent owner, had identified Genentech

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in its real party and interest statement both before this court and in the record below.

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Pfizer had a patent dispute with Genentech and its parent company Roche who also controls ChuGuy.

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At the time the appeal was initiated, that patent dispute was ongoing and ultimately subsequent to the initiation of the appeal,

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the patent dispute was settled and true guy, neither true guy nor the patents at issue here were included in the settlement.

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So at the time Pfizer initiated the appeal, Pfizer had good reason or Pfizer had no reason to believe this standing was not self evident.

[00:02:46] Speaker 02:
Yeah, but what's missing it seems to me is any information about your plans

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as of January 30, 2019, when the notice of appeal was filed.

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There's information about a planned launch later in October, but I don't see anything addressing the situation as of January 30.

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At that, thank you, Your Honor.

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At that time, the, at that time, the Pfizer had its BLA on file,

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before the FDA, and all the parties in this appeal were aware of this fact.

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As I mentioned, Rose... Where is that in the record?

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It's self-evident from the record, Your Honor, because Pfizer... Well, the product here is rituximab, and the product was identified in the petition, albeit in an email.

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email reflector, ChuGuy obviously knew that the product was involved here because ChuGuy in the record below identified Genentech as a real party in interest.

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So it was self-evident to the parties here that there was a product at issue in this case at the time of the appeal, Your Honor.

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As I mentioned, the product was the subject of a patent dispute between Genentech and Roche, which controls Shugai.

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And as I also mentioned, Shugai identified Genentech as the real party in interest in the record below in the IPR at that appendix 1579.

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The product that was the subject of that dispute, the Rituximab product,

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is made using protein A chromatography.

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And that is the method for purifying protein that's described and claimed in the patents at issue in this case.

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Pfizer settled with Genentech and Roche.

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And as I mentioned, neither Chugai nor the patents at issue here were included in that settlement.

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and ChuGuy is free to assert those patents even today.

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This injury in fact, that is that there's a substantial risk that ChuGuy will bring an action for infringement, is further compounded by the estoppel provisions of 35 USC Section 315E.

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Those provisions could limit Pfizer's invalidity theories in subsequent actions

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including the anticipated infringement action that Pfizer expects from QGuy.

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Turning to the merits of the case, unless the court has any other questions on standing, I'd like to turn to the merits of the case.

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On the merits, the board incorrectly found that the disclosure

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of an acidic 25 millimolar citrate solution in the Shadel reference, which is the only reference at issue below, the court found that that reference did not provide enough information to meet the claimed molarity limitations in these claims.

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And in making this finding, the board erroneously construed the molarity limitation in the claims.

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The board construed the molarity limitation as the overall molarity of the solution and not of any particular solute within the solution.

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The final written decision below also refers to this as the total solute or total molarity.

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And Pfizer's position is that the board's construction is inconsistent with the intrinsic evidence for several reasons.

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First, the specification nowhere describes or calculates the overall molarity for either the acidic aqueous solutions described in the specification or the neutralized LUA described in the specification.

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In addition, the prosecution history describes the molarity of acidic aqueous solutions in the prior art.

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solely by reference to the components identified in those solutions, rather than by the total molarity construction that the board adopted.

[00:07:47] Speaker 03:
Your Honor, we believe that... But you, I mean, I know, I know Fairgate referring us to the intrinsic record of the specification of the prosecution history, but it seems to me that the plain language of the claims seems to refer to a concentration of the solution as a whole, not a single solute.

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And I think that's pretty persuasive in supporting the board's claim construction here.

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I'd also just sort of, you could address that, but also the fact that you had a shifting claim construction, right?

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You all have been changing your position on the correct claim construction during this proceeding.

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Am I correct about that as well?

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Well, to answer the questions in order, Your Honor, we think that the,

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The claim term acidic aqueous solution is focusing on the identified components, the molarity of the identified components that make the solution acidic.

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We think that the total molarity construction that the board has adopted is just unworkable because it requires knowledge of how the particular solution was prepared.

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As you can imagine, these solutions are prepared in different fashions and they often contain unknowable, unidentified, unidentifiable solutes in the solution.

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It's a construction that while the claim says solution, looking at the claim language alone and saying that

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You have to look at all known and unknown solutes in the solution is just an unworkable construction.

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And that's supported or that our position is supported by the fact that when you look at the specification of the patent, for example, when you look at the acidic aqueous solutions that the patent describes, it follows exactly the approach that Shadel found.

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The specification identifies the solutions by the molarity of the aqueous component.

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And secondly, we did not shift constructions.

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By giving solute in our construction, we meant the identified solutes.

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Your Honor, I'd just like to take another minute or two into my rebuttal time, if that's okay.

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address the SHADL reference and that's if that's okay.

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That's to say that the SHADL, you know, the board erroneously found that the SHADL reference requires, you know, a showing of how the, excuse me, determination of molarity of the SHADL reference requires a determination of how the reference was made.

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And that simply goes beyond the board's construction and beyond the specification.

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And most importantly, the European, ChuGuy in the European Patent Office characterized the SHADO reference and characterized the citrate solution of the SHADO reference as a 25 millimolar solution.

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ChuGuy itself in Europe did not use the board's total molarity construction.

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I'll finish your honor and reserve the rest of the time for rebuttal.

[00:11:32] Speaker 03:
Let me ask you a quick question about, and this just goes to the anticipation question.

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It is correct, is it not, that before the board, at least until you got into your reply, you had not raised the Inherency Theory of Anticipation relying on the disclosure in Shadle.

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Am I right about that?

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That's correct, Your Honor.

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Okay.

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and therefore the other side didn't have an opportunity to respond.

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Isn't that problematic for you, for us to reach that issue on appeal?

[00:12:07] Speaker 00:
Your Honor, we believe the other side did have the opportunity to respond.

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The inherency evidence was or the evidence underlying our reply was supplied

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before the deposition of our expert, the other side was able to depose that expert before its patent owner response.

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Well, isn't there a difference?

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Even if assuming you're correct, in other words, that the evidence is the same, and I'm not a thousand percent clear on that, but it's still up to you to make the argument.

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Why are they, how are they unnoticed that you're making an inherency argument, not withstanding, but the evidence that you're now using may have already been in the record?

[00:12:58] Speaker 00:
Your Honor, we made the argument in the reply as, you know, based on the evolving construction here, but at bottom, we believe that the evidence shows that the plain term is expressly met, so the inherency issue

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It takes lesser priority in our view than the fact that Shadel expressly anticipates the claim under either our construction or the board's construction.

[00:13:28] Speaker 02:
How did their expert affidavit addressing the inherency question get into the record?

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Thank you, Your Honor.

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Their expert team responded to our arguments that

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We provided the evidence before.

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When did they submit their expert declaration on the subject of inherency?

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They submitted it with their patent owner response.

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So were they addressing the issue of inherency in the patent owner response?

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The patent owner response was addressing the calculations that our expert provided

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which our expert provided to show that the claim was met even under the board's total solute construction.

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So after the institution, petitioner provided an expert updated calculations to show that even under the board's construction, the claim terms would nevertheless be met.

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And petitioner, excuse me, patent owner, its patent owner response came back with Dr. Cramer's declaration

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which addressed those calculations and said that in addition to the four methods that our petitioner's expert provided, there was an additional fifth method which patent owner's expert said was purportedly available.

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And we disagree with that for the reasons we stated in the record, Your Honor.

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Okay.

[00:15:06] Speaker 03:
The other side.

[00:15:09] Speaker 03:
Thank you.

[00:15:16] Speaker 01:
Good morning, Your Honor.

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May it please the Court?

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There are a couple issues that have not been raised, and I'm happy to address the issues that were discussed.

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If the Court has questions on the other issues, I'm happy to address those as well.

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As to standing, there is no evidence sufficient to support Pfizer's assertion of injury in fact here, not at the beginning of the appeal and not now.

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Just a few corrections of the statements

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made by Mr. Scheibler.

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There is no showing here that Chewguy and Pfizer are competitors, as we addressed in our papers.

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The identification of the real party in interest here and below was out of an abundance of caution.

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in Appendix 1579, we stated we didn't believe Genentech would actually be considered a real party in interest below.

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And here, as we indicated, we included them for purposes of screening case conflicts in terms of... Well, what do we... I'm sorry to interrupt, but what do we make of that?

[00:16:20] Speaker 03:
I mean, you know, the other side kept talking about, using the phrase, it was self-evident.

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You can tell us now that we put in a real party of interest and we really didn't mean it.

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But if we're supposed to conclude that it was self-evident, don't we take it as a given that you identified them as a real party of interest in your case?

[00:16:42] Speaker 01:
Your Honor, we did identify them as a real party of interest.

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That is not sufficient to show that Pfizer had standing here.

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The parties to the dispute did not include QGuy.

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We did not receive an ABLA from Pfizer.

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We are addressing patents here that are not specific to Rituximab, which is the product that Pfizer and Genentech had a dispute about.

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And Genentech is not licensed on these patents.

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So to suggest it's simply because Pfizer included the word Rituximab in the email service address in its petition.

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And that as a result of that, we identified Genentech because they sell Rituximab in the United States.

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So that makes Pfizer standing with injury and factor yourself evident, I think, is not supported by the record.

[00:17:37] Speaker 01:
as to the assertion regarding protein chromatography and that that being sufficient to us that we're standing now, the only evidence we have from Pfizer about supposed injury is that Pfizer says GIC has a process that involves use of protein A chromatography, that's appendix 6325 paragraph 10, and that the patents somehow relate to protein A chromatography.

[00:18:02] Speaker 01:
The problem with this argument is that protein achromatography was well known and widely used long before these patents, the final written decision.

[00:18:11] Speaker 02:
They say that they think there's a risk that they would get sick.

[00:18:17] Speaker 01:
They say may... I'm sorry, Your Honor.

[00:18:19] Speaker 01:
Yes.

[00:18:19] Speaker 01:
Judge, like they say may, they may be sued and they don't explain why.

[00:18:24] Speaker 01:
It's their burden to show that their actions are likely to cause a suit, not that someone may bring a suit.

[00:18:31] Speaker 01:
Anyone can assert may bring a suit.

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And that removes Article 3 as the floor that this court has confirmed it is.

[00:18:38] Speaker 03:
Well, what about you?

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I mean, are you... should we...

[00:18:42] Speaker 03:
And how would we suggest to you if you represent whether or not you will bring the suit?

[00:18:49] Speaker 01:
Your Honor, I'm not aware of any concrete plans to bring a suit, but there's nothing in the record from Pfizer on this.

[00:18:55] Speaker 01:
And as the court has noted, they need to show standing for the entirety of these appeals.

[00:19:02] Speaker 04:
But you're not prepared to make a representation to the court at this point that no such suit will be brought.

[00:19:09] Speaker 04:
I take it from your answer.

[00:19:11] Speaker 01:
Judge Bryson, no, I'm not in a position to make that representation.

[00:19:15] Speaker 01:
But I think, again, that's the kind of thing that would remove Article III as a floor.

[00:19:19] Speaker 01:
If every appellee were asked, well, will you covenant out to sue standing here today?

[00:19:24] Speaker 01:
That could be asked by consumer watchdog, by phygenics, by all the appellants that have been found not to have standing here.

[00:19:36] Speaker 02:
Could you address the merits

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here if my colleagues have other questions about sanding.

[00:19:44] Speaker 02:
We have a record here where if you make the product using four methods, the anticipatory product using four methods, there's anticipation but not under a fifth method.

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And their expert says that the four methods were

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the normal, unusual way of doing it, and the fitness is not.

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And I look at your expert declaration.

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I don't see that he really contradicts that.

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And then I look at the board decision, and when I read the board decision, I see them paying lip service to the normal, unusual standards, but the language that they use

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really in places seems to suggest that a mere possibility or that was reasonable to use a fifth method is sufficient to defeat anticipation.

[00:20:44] Speaker 02:
Could you address that?

[00:20:47] Speaker 01:
Yes, Judge, thank you for asking.

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So first, I think the language normal and usual is being brought in for a different purpose.

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I don't think it's actually the standard here.

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We're looking at available methods to a person of ordinary skill.

[00:20:59] Speaker 02:
Why isn't that the standard, you know, going all the way back to the Carnegie case in the Supreme Court and we have King and we have other cases which says that's the standard.

[00:21:09] Speaker 02:
That's not the standard?

[00:21:10] Speaker 01:
Your Honor, those cases are about what happens when you know, say, the inputs to a process.

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What is the normal and usual result of those inputs?

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What would they result in?

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And that is not the situation we have here.

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Here, we are looking at, for example, the acidic aqueous solution.

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That's not the result of two things that are known.

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And all of a sudden, you end up with the acidic aqueous solution.

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That's one of the inputs here.

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So if in King, for example, if you take two things together and you have proof that those happen, you get the result.

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But here we don't have the impetus.

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There is no proof.

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that SHADL actually met the molarity limitation for its acidic aqueous solution.

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So that function of those cases is not about what would be known to a person of skill as available.

[00:22:06] Speaker 01:
It's an attempt to fill a gap in what is disclosed in SHADL.

[00:22:11] Speaker 02:
Well, let's suppose hypothetically that we were to conclude that the normal neutral standard does apply here.

[00:22:19] Speaker 02:
What's your response to the fact that their expert said that the FIS method was not a normal usual method, that your expert didn't say that it was, and that the board seems to have applied a different standard?

[00:22:37] Speaker 01:
Your Honor, the testimony here, and it's on pages 21 and 22 of the appendix, shows that Dr. Cramer testified it was

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a well-known, readily available, and reasonable choice to a person of ordinary skill in the arts.

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And the board credited that.

[00:22:55] Speaker 02:
That's not the same as normal and usual, is it?

[00:22:59] Speaker 01:
Your Honor, I'm not sure there's a meaningful difference there.

[00:23:03] Speaker 01:
The test is not what is the most popular choice.

[00:23:08] Speaker 01:
It's like saying, because chocolate, strawberry, and vanilla are the most popular choices,

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that chocolate chip is not a reasonable choice, is not normal.

[00:23:18] Speaker 01:
That's really the analysis we're getting from Dr. Prisvichyan and Pfizer.

[00:23:23] Speaker 01:
What the testimony here shows is that this was a readily available choice, and Dr. Kramer explained the reasons a person of ordinary skill would use this choice based on the reagents that were available, preferences, the level of experience, and so forth.

[00:23:38] Speaker 01:
He showed an example.

[00:23:39] Speaker 02:
I'm not sure that under the cases that

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The fact that something is a reasonable or available choice makes it a normal and usual way of doing it.

[00:23:51] Speaker 01:
Your Honor, I'm not sure that, again, that the normal and usual language, which is to talk about what occurs when there's not explicit disclosure of the result, is actually the applicable test here.

[00:24:06] Speaker 01:
I know that the board addressed that as well.

[00:24:11] Speaker 01:
criticisms that Dr. Prisvishyan made about the.

[00:24:18] Speaker 01:
The trisodium citrate option that Dr. Kramer testified about were expressly considered and rejected by the board.

[00:24:27] Speaker 01:
So to his effort to show that it was somehow not normal to use trisodium citrate, the board responded that it was indeed possible to do that.

[00:24:39] Speaker 01:
It was an available choice.

[00:24:40] Speaker 01:
A person could have used it.

[00:24:42] Speaker 01:
It would have been, as I said earlier, well-known, readily available, and a reasonable choice.

[00:24:47] Speaker 01:
that could reasonably be elected by a person of skill.

[00:24:51] Speaker 01:
Two other quick points on this, Judge Dyke.

[00:24:53] Speaker 01:
First, Dr. Kramer, excuse me, Dr. Prisvice did not testify that there were only five methods.

[00:24:59] Speaker 01:
In fact, he said in the record, this is exhibit 2020 at page 157, that there are many methods of preparing the buffers.

[00:25:07] Speaker 01:
The evidence in the record shows that there were more than his four and Dr. Kramer's one.

[00:25:12] Speaker 01:
And what's happening here is that it's their burden to show

[00:25:17] Speaker 01:
The counter example that we've pointed out here simply shows the shortcomings in that.

[00:25:21] Speaker 01:
And that's what the board concluded at page 29 of the appendix.

[00:25:26] Speaker 01:
So we win, for that matter, even if there are only four methods, using wash buffer 2.1 liters with Dr. Prisvicean's formula number one would yield a molarity that's outside the range at 2332 of the appendix.

[00:25:46] Speaker 01:
One other point in response to the comment earlier about the timing of expert declarations, we did not have an opportunity to submit an expert declaration after they put in their reply position on inherency.

[00:26:13] Speaker 01:
And there's certainly no abuse of discretion that's been demonstrated here in the board's decision to find the inherent argument to have been late and improper.

[00:26:26] Speaker 01:
Unless there are further questions, I'm happy to turn my time back to the court.

[00:26:34] Speaker 03:
Colleagues, thank you.

[00:26:37] Speaker 03:
Thank you, Your Honor.

[00:26:43] Speaker 03:
Time for rebuttal.

[00:26:45] Speaker 03:
How much time is remaining, Michael?

[00:26:48] Speaker 03:
Only 18 seconds, Your Honor.

[00:26:50] Speaker 03:
Oh, OK.

[00:26:50] Speaker 03:
Well, we'll restore several minutes on rebuttal.

[00:27:03] Speaker 00:
Mr. Scheibeler?

[00:27:07] Speaker 00:
Thank you, Your Honor.

[00:27:08] Speaker 00:
I apologize.

[00:27:09] Speaker 00:
We agree that the board's decision only, you know, paid lip service to the problems with the two guys' evidence concerning the fifth method espoused by Dr. Cramer.

[00:27:23] Speaker 00:
But more importantly, we think that the evidence below shows clearly here that there is a strong case for express anticipation by the Shadel reference.

[00:27:35] Speaker 00:
If the court would look to pages 16 and 17 of the final written decision, what you'll see is that the final written decision required more from its own claim construction in analyzing the Shadel reference because it said for Shadel to anticipate, one needs to determine how the buffering Shadel was made.

[00:27:59] Speaker 00:
And that goes far beyond the claim construction and it goes far beyond anything that's in the specification of the challenge

[00:28:05] Speaker 00:
patents here.

[00:28:07] Speaker 00:
The fact is that the challenge patents identify its aqueous acidic solutions at the same, to the same level of granularity as Shadel.

[00:28:17] Speaker 00:
I'll give you a quick example.

[00:28:18] Speaker 04:
Shadel says 25... Doesn't Shadel have to disclose what it is about its formula that gets you to under 100 millimoles?

[00:28:33] Speaker 04:
I don't see that Shadel contains enough information to make that determination setting, but just by itself.

[00:28:43] Speaker 00:
Thank you, Your Honor.

[00:28:44] Speaker 00:
By itself, there's nothing in Shadel to lead an artisan to doubt that it shows anything other than a 25 millimolar solution containing citrate and citrate only.

[00:28:58] Speaker 00:
The interesting thing is that the evidence... That depends, does it not, on the acceptance of your claim construction?

[00:29:10] Speaker 00:
We believe it does not, Your Honor, because the evidence below shows that the

[00:29:18] Speaker 00:
Our expert came with four methods to show how the Shadles buffer could be made, the conventional methods, and in fact showed that methods three and four were the most conventional methods used in the industry, and even Dr. Kramer, ChuGuy's expert, used those methods.

[00:29:35] Speaker 00:
Those methods three and four both use citric acid and sodium, and form sodium citrate to create the buffer.

[00:29:42] Speaker 04:
Those two most conventional... That seems like its inherency argument, not the express disclosure argument.

[00:29:49] Speaker 00:
Well, we believe it's expressed, Your Honor, because those two methods, that is methods three and four, which are the most conventional methods, yield

[00:29:59] Speaker 00:
Exactly what Schadl says they yield, a 25 millimolar solution that contains all citrate.

[00:30:06] Speaker 00:
And this is only buttressed by the fact that even the other methods, the other two methods that Dr. Prisbesian testified, yes, they show a molarity higher.

[00:30:16] Speaker 00:
But in both those cases, the molarity of the acidic aqueous solution was 30 and 44, still significantly below the molarity of the claim limitation.

[00:30:27] Speaker 00:
There's no evidence of record here to show that an acidic aqueous solution of Shadel was anything other than 25 millimolar.

[00:30:38] Speaker 00:
And at best, there's certainly no evidence to show that an artisan would make that buffer that could be made over 100 millimolar.

[00:30:49] Speaker 00:
So we think there's a strong case for expressed anticipation here because

[00:30:55] Speaker 00:
Shadel says it's a 25 millimolar solution, and it's citrate, full stop.

[00:31:01] Speaker 00:
That's really how artisans would look at this, and Dr. Prisbesian's evidence shows that.

[00:31:10] Speaker 00:
And if I could just say one word on standing here, Your Honor.

[00:31:16] Speaker 00:
You know, counsel said that Genentech is not licensed under these patents.

[00:31:20] Speaker 00:
That's a new fact that is not in the record below.

[00:31:23] Speaker 00:
And counsel, the court questioned counsel about the willingness to stipulate to infringement.

[00:31:32] Speaker 00:
And I can, the court I believe will know that that kind of question has been asked to counsel in previous cases.

[00:31:41] Speaker 00:
For example, in the Altair case, that was asked of counsel at oral argument.

[00:31:45] Speaker 00:
Counsel refused, and Altair found standing.

[00:31:49] Speaker 00:
So that buttresses our position on standing.

[00:31:54] Speaker 00:
And these parts... Excuse me.

[00:31:57] Speaker 03:
Just one more sentence, because your time has expired.

[00:32:00] Speaker 00:
Okay.

[00:32:00] Speaker 00:
Thank you, Your Honor.

[00:32:01] Speaker 00:
I'll finish there.

[00:32:02] Speaker 03:
Thank you for your time.

[00:32:05] Speaker 03:
Did any of my colleagues have further questions?

[00:32:07] Speaker 03:
I'm sorry.

[00:32:07] Speaker 03:
Did I?

[00:32:10] Speaker 02:
No.

[00:32:10] Speaker 03:
Judge Bryson?

[00:32:11] Speaker 03:
No.

[00:32:12] Speaker 03:
We thank both parties and the case is submitted.

[00:32:16] Speaker 03:
Thank you.