[00:00:08] Speaker 05:
The first case for argument this morning is 181933, Genentex versus Hispira.

[00:00:14] Speaker 05:
Mr. Fletcher, good morning.

[00:00:29] Speaker 03:
Good morning, Your Honors.

[00:00:30] Speaker 03:
Thomas Fletcher for Appellant Genentex.

[00:00:35] Speaker 03:
The board's first two mistakes in this inter partes review concerned its analysis of anticipation.

[00:00:42] Speaker 03:
And the same theme pervades both mistakes, the theme of failure to follow this court's precedence.

[00:00:49] Speaker 03:
The first failure to follow this court's precedent concerns the court's construction of the term about 18 degrees Celsius in the claimed methods.

[00:01:01] Speaker 05:
I'm sorry to interrupt and I'll let you pick up where you are, but just a sort of technical housekeeping question in connection with this and your other arguments, which is you've got eight grounds here.

[00:01:13] Speaker 03:
Correct.

[00:01:14] Speaker 05:
And five of those, at least, implicate claim one, which is the major representative claim here.

[00:01:22] Speaker 05:
So I'm just trying to figure out how many.

[00:01:26] Speaker 05:
I mean, let's assume that the claim construction, you're right on the claim construction.

[00:01:31] Speaker 05:
And we agree with that.

[00:01:32] Speaker 05:
We've got a lot to overcome, right?

[00:01:37] Speaker 05:
So can you, when you're talking about claim construction, can you be more precise in terms of which of the grounds that would affect and not affect, and then make sure you reach the ones, even if we agree with you, that are implicated here?

[00:01:50] Speaker 03:
Thank you.

[00:01:50] Speaker 03:
Certainly, Your Honor.

[00:01:51] Speaker 03:
Yes.

[00:01:52] Speaker 03:
I think the Court's final written decision can be analyzed under four headings.

[00:01:58] Speaker 03:
And the Court's

[00:02:02] Speaker 03:
The PTAB had two anticipation grounds, and one of those is completely disposed of by the about dispute.

[00:02:11] Speaker 03:
That's anticipation.

[00:02:12] Speaker 05:
But not the other.

[00:02:14] Speaker 05:
The W0389 isn't affected by the flame construction, am I right?

[00:02:18] Speaker 03:
It's implicated, but anticipation doesn't resolve that issue.

[00:02:24] Speaker 03:
Your Honor is correct.

[00:02:25] Speaker 03:
There, power chunk.

[00:02:27] Speaker 04:
If we were to affirm the W0389, that would end the case completely, right?

[00:02:34] Speaker 04:
And we wouldn't have to confront the claim construction question you're leading with.

[00:02:38] Speaker 03:
Is that right?

[00:02:40] Speaker 03:
It would take care of the anticipation grounds.

[00:02:42] Speaker 03:
You'd then need to get to the obviousness analysis.

[00:02:46] Speaker 03:
For some of the dependent claims?

[00:02:47] Speaker 03:
For some of the dependent claims, yes.

[00:02:49] Speaker 03:
OK.

[00:02:51] Speaker 03:
So maybe I'll move on to the problem with W0389 and the anticipation issue there.

[00:02:56] Speaker 03:
And I think the problem is an inappropriate interpretation of this court's Kenamettle decision.

[00:03:05] Speaker 03:
I think this court's Kenamettle decision has already been recognized to have been misunderstood by the PTAB.

[00:03:11] Speaker 03:
And this court in Nidek Motor

[00:03:14] Speaker 03:
pointed out that the PTAB was not interpreting it correctly.

[00:03:18] Speaker 03:
And so to read from Nidek Motor, this court said, Kenna Metal does not stand for the proposition that a reference missing a limitation can anticipate a claim if a skilled artisan viewing the reference would at once envisage the missing limitation.

[00:03:38] Speaker 03:
But if we go to the PTAB's final written decision at appendix page 17,

[00:03:43] Speaker 03:
The PTAB is citing Kenamodel for precisely that proposition, that it can find anticipation based on what the person of ordinary skill would envisage based on reading the record.

[00:03:54] Speaker 05:
Well, let me ask you.

[00:03:55] Speaker 05:
Kenamodel, I mean, that's a quote out of Kenamodel.

[00:03:59] Speaker 05:
At once envisage a subsequent panel opinion can't overrule a prior opinion, right?

[00:04:06] Speaker 03:
So we can't ignore Ken metal just because some subsequent panel may have said well You're correct that subsequent panel cannot overturn a first panel but I think a subsequent panel can explain the context for the prior panels holding and

[00:04:25] Speaker 03:
And in Kennemetal, there is a very small group of elements from column A and a very small group of elements from column B in the dispute concerned whether that reference disclosed the combination of a particular item from small group A and a particular item from small group B. And this court said, these are very short lists.

[00:04:46] Speaker 03:
All of those combinations are disclosed because that's what the substance of that disclosure meant.

[00:04:54] Speaker 04:
So we understand Kenamettle and the whole principle of can one have ordinary skill in the art of reading a reference that once envisaged the invention that is claimed.

[00:05:04] Speaker 04:
Can we take that now to your case?

[00:05:06] Speaker 04:
What happened that went wrong here with your case?

[00:05:09] Speaker 04:
Certainly.

[00:05:10] Speaker 04:
The reference says you do this protein A affinity chromatography step.

[00:05:20] Speaker 04:
at about 10 degrees Celsius to about 18 degrees Celsius, right?

[00:05:25] Speaker 04:
And then we've got W0389 that says, let's do this protein A affinity chromatography at room temperature, 18 degrees Celsius to 25 degrees Celsius.

[00:05:39] Speaker 04:
So then W0389 says all the steps are being done at that temperature.

[00:05:49] Speaker 04:
So then the board interpreted that as, aha, we've got the 18 degrees overlapping in the prior reference in the claimed invention.

[00:06:00] Speaker 04:
And so therefore,

[00:06:04] Speaker 03:
here we have anticipation yes and i think uh... your honor the flaw in the analysis there was that allegedly anticipating reference W-389 says all steps carried out at room temperature and gives this range for what it considered room temperature a very chilly room

[00:06:23] Speaker 03:
The problem lies in the fact that as the board recognized at appendix page 20, that's not a disclosure of the temperature of the fluid that's being put onto the column.

[00:06:37] Speaker 03:
It's undisputed amongst the experts and nobody distinguished or...

[00:06:44] Speaker 04:
board had two rationales.

[00:06:46] Speaker 04:
One was this reference says all the steps in W0389 are being performed at 18 degrees to 25 degrees Celsius.

[00:06:57] Speaker 04:
And so therefore that means, as supported by the petitioner's expert, that every single component

[00:07:04] Speaker 04:
of the technique is going to be done at 18 degrees Celsius, including the HCCF composition that's, you know, flowing through the column.

[00:07:17] Speaker 04:
And so that's theory number one.

[00:07:19] Speaker 04:
Theory number two is even if that HCCF formulation is at initially a warmer temperature than, like, say, 37 degrees Celsius, by the time it gets poured through the column, during the

[00:07:34] Speaker 04:
chromatography process, it's going to cool down because everything else is at anything between 18 to 25 and so it will equibrate down to the very temperature that's being discussed.

[00:07:50] Speaker 04:
So those are really two different theories.

[00:07:51] Speaker 04:
One is based on

[00:07:53] Speaker 04:
reading the reference expressly, and then the second one is perhaps more of an inherency theory that inherently the HCCF is going to go down and increase lawsuits.

[00:08:04] Speaker 03:
Yes, Your Honor.

[00:08:05] Speaker 03:
They did have those two headings in there.

[00:08:07] Speaker 04:
So what's wrong with the first one?

[00:08:09] Speaker 04:
Why isn't that supported by substantial evidence?

[00:08:11] Speaker 04:
We have a reference.

[00:08:13] Speaker 04:
It could be clearer, but then they have expert testimony explaining that no person of ordinary skill in the art

[00:08:19] Speaker 04:
understanding that they have to do this experiment according to W0389 at a particular temperature is going to throw in some kind of formulation at a super hot temperature to throw off the entire requirements of what the temperature should be for the technique to occur.

[00:08:42] Speaker 03:
And the problem with that, Your Honor, and why it's not supported by substantial evidence goes to, I think, the fact that the board is just quoting from the petitioner's expert's reply declaration.

[00:08:55] Speaker 03:
In fact when he was actually cross-examined prior to submitting his reply declaration.

[00:09:00] Speaker 03:
He conceded that there's no Guarantee that any of this material has cooled to room temperature that makes sense given that the point of these industrial processes is to keep this moving take this material that could be getting degraded or breaking down and get it purified and it starts warm and then gets purified and

[00:09:22] Speaker 03:
So he testified under cross-examination that it's not inevitable that it would be cooled down and then submits contradictory reply declaration testimony.

[00:09:32] Speaker 03:
Now, I suppose the board could have chosen to credit the reply declaration testimony, but it needs to grapple with the fact that when the man was actually put under oath to testify in response to our questions, he agreed with us.

[00:09:49] Speaker 03:
And I think that's a proposition that flows from your in-rate COTSAB case, that you can weigh the evidence and come out on one side or the other, but you have to actually do the weighing.

[00:10:01] Speaker 03:
And I think it's particularly problematic to credit an expert's reply declaration over their cross-examination testimony without even so much as an acknowledgment of the contradiction.

[00:10:15] Speaker 04:
What about the 103s?

[00:10:18] Speaker 03:
Certainly.

[00:10:19] Speaker 03:
So switching to the 103 analyses, your honor.

[00:10:21] Speaker 04:
Was it known in the art that proteolysis was temperature dependent?

[00:10:26] Speaker 03:
That, I think, is not a finding that we are challenging on appeal.

[00:10:32] Speaker 03:
We challenged it below, but they made that finding.

[00:10:34] Speaker 04:
So then the board found that it was therefore known in the art that temperature was a result-effective variable.

[00:10:41] Speaker 03:
Yes.

[00:10:41] Speaker 03:
And so I'd like to address that, because there are two different obviousness rationales.

[00:10:45] Speaker 03:
Both of them fall under this invocation of, oh, this would all be routine.

[00:10:49] Speaker 03:
And so they did it based on temperature, and they did it based on another variable called binding capacity.

[00:10:56] Speaker 03:
I'll start with temperature.

[00:10:58] Speaker 03:
With temperature, the problem is one of incompatible findings.

[00:11:02] Speaker 03:
So yes, they found that temperature affects proteolysis.

[00:11:08] Speaker 03:
They also found that leaching is undesirable because it generates this very small amount of a antigen

[00:11:20] Speaker 03:
that would be bad for humans if you inject it.

[00:11:23] Speaker 03:
And they also found that at laboratory scale, you can control the temperature of these solutions readily.

[00:11:29] Speaker 03:
The problem is, you can't take all of these individual findings, put them together, and form an ultimate conclusion of obviousness.

[00:11:37] Speaker 03:
Because it was unrefuted that, in fact, controlling temperature at the scale of industrial purification was an extremely burdensome task that nobody was doing.

[00:11:50] Speaker 03:
And so when you try and piece the board's findings together, they don't actually add up.

[00:11:58] Speaker 03:
And that's what's wrong with that temperature analysis.

[00:12:01] Speaker 04:
I mean, I don't recall seeing your patent specification talk in these terms about how difficult it is to control temperature.

[00:12:11] Speaker 03:
I think we put in the expert testimony on that, and it's not a matter of that we had to invent new ways of refrigerating, it's that it's extremely expensive and it adds time and equipment to the process that isn't normally there if you just proceed to purify warm cell culture fluid.

[00:12:31] Speaker 04:
Is that true also for laboratory scale?

[00:12:34] Speaker 04:
usages of this claimed invention?

[00:12:37] Speaker 03:
And this is where the purpose of the motivation is so critical.

[00:12:41] Speaker 03:
At laboratory scale, you're not making a human therapeutic.

[00:12:44] Speaker 03:
You don't care about leached protein A. The amount of leached protein A in the solution that comes out at the bottom is, as we said, literally measured in nanograms.

[00:12:53] Speaker 03:
The only reason it is of any concern is if you're going to turn around and inject it into a patient.

[00:12:59] Speaker 03:
But if you're just performing laboratory bench top analysis, the presence of that leached protein A is irrelevant to you.

[00:13:07] Speaker 03:
That also wasn't refuted in the record.

[00:13:10] Speaker 03:
So that's the problem with the temperature-based routine optimization rationale.

[00:13:15] Speaker 03:
If I could just briefly address the second routine optimization rationale.

[00:13:21] Speaker 03:
Here, they relied on a single paper from a decade before the priority date, suggesting that temperature could also affect how much the column could bind.

[00:13:32] Speaker 03:
That's what I'm asking.

[00:13:33] Speaker 03:
Are we talking about band summary?

[00:13:34] Speaker 03:
That's correct.

[00:13:35] Speaker 03:
This is the obviousness over van Sommert.

[00:13:38] Speaker 03:
And the problem there was that obviousness must be analyzed as of the time of the invention.

[00:13:43] Speaker 03:
That's clear from the statute.

[00:13:45] Speaker 03:
In that intervening decade, there were multiple publications explaining how to optimize the protein A process.

[00:13:55] Speaker 03:
And several of them acknowledged the fact that this Van Sommeren paper was out there and proceeded to say, that's a bad idea.

[00:14:02] Speaker 03:
Changing the temperature can affect product quality.

[00:14:05] Speaker 03:
Here are the parameters along which you should optimize your protein A process.

[00:14:09] Speaker 03:
And these are the parameters that will result in a good protein A process.

[00:14:14] Speaker 03:
And I think the fact that over the intervening decade, you find no examples even hinting at the idea of optimizing on temperature goes to show that this is a hindsight-infected rationale, just like the kind that this court called out in the Leo Pharma case.

[00:14:33] Speaker 03:
The fact that there's so much time between the purported disclosure, the motivation that would make this all obvious and routine, and the actual invention, goes to show that you can only go back and look at that earlier reference and say, oh, it's also clear and routine through the use of hindsight.

[00:14:50] Speaker 05:
OK.

[00:14:50] Speaker 05:
You're entering bubbles.

[00:14:51] Speaker 05:
Yes, I see that.

[00:14:52] Speaker 05:
I'm going to sit down, and we'll restore some of that.

[00:14:54] Speaker 03:
Thank you, Your Honor.

[00:14:59] Speaker 05:
Mr. Mallory?

[00:15:04] Speaker 02:
Good morning, Your Honor.

[00:15:06] Speaker 02:
May it please the Court, Thomas Meloro, for the appellee, Jaspira.

[00:15:11] Speaker 02:
The judgment of the board was grounded on multiple independent bases.

[00:15:17] Speaker 02:
There were two different anticipation references with two different sets of issues surrounding them.

[00:15:23] Speaker 02:
There were also obviousness determinations on multiple grounds.

[00:15:27] Speaker 02:
And those obviousness determinations have several independent bases to them.

[00:15:32] Speaker 02:
One is an obviousness determination based on the control of temperature for improving proteolysis.

[00:15:39] Speaker 02:
Second is the motivation to improve binding capacity.

[00:15:43] Speaker 02:
And third is obviousness that comes from the fact that there is no criticality to the claimed range.

[00:15:51] Speaker 02:
That is something that Genentech has conceded on appeal.

[00:15:54] Speaker 02:
There's absolutely no criticality to the claimed range.

[00:15:56] Speaker 04:
Could you respond to some of the arguments that we heard today?

[00:15:58] Speaker 04:
For example, on the W0389, the other side's talking about how your expert was saying contradictory things.

[00:16:06] Speaker 04:
And so therefore, we can't find that there's substantial evidence to conclude that

[00:16:14] Speaker 04:
all of the steps in W0389 would in fact be performed at 18 degrees Celsius.

[00:16:22] Speaker 02:
Yes, on W0389 the board found

[00:16:27] Speaker 02:
that there was substantial evidence on two different bases.

[00:16:30] Speaker 02:
One is the reference itself says all steps carried out at 18 to 25 degrees C. The other aspect of the board's decision is where counsel, I think, is relying on the testimony from Dr. Probitzian.

[00:16:46] Speaker 02:
And Dr. Probitzian's testimony was that, in fact, the temperature of all of the components would equilibrate

[00:16:55] Speaker 02:
over time to that 18 to 25 degrees C, even if one were to assume that you didn't start with fluid at 18 to 25 degrees C. So on the first round of the board's decision, Dr. Prabitsian testified, and it was adopted by the board,

[00:17:14] Speaker 02:
that no one would ignore that direction from the reference to operate at 18 to 25 degrees C and do what Genentech speculates that the reference might be allowing, which is starting with composition that's not at 18 to 25 degrees C. In fact, Genentech's expert, Dr. Kramer, testified that he was unaware of any commercial process in which one did what Genentech

[00:17:42] Speaker 02:
postulates that the reference might be teaching here, which is starting with warm HCCF that's not been equilibrated.

[00:17:50] Speaker 01:
To run it at 18, don't you always need some sort of external cooling, particularly on this theory of equilibrating the 25?

[00:18:00] Speaker 02:
Well, it depends, I guess, on the temperature of the surroundings, and perhaps in Washington, DC.

[00:18:06] Speaker 01:
These are not on control.

[00:18:08] Speaker 01:
These are industrial processes in a structure where the temperature of the surrounding is controlled.

[00:18:17] Speaker 01:
But even so, to run it at 18, wouldn't you have to assure that there is some mechanism for cooling the ambient temperature?

[00:18:29] Speaker 02:
If the ambient temperature were higher than 18, then there would have to be a cooling mechanism.

[00:18:34] Speaker 02:
And Dr. Prabitsian testified that those cooling mechanisms were in fact known in the art.

[00:18:41] Speaker 02:
And Dr. Kramer acknowledged that those cooling mechanisms were known in the arts.

[00:18:46] Speaker 02:
So there were steps that could be carried out conventionally.

[00:18:50] Speaker 02:
And in fact, the patent itself, Your Honor, the specification at certain points says to carry out at 15 degrees.

[00:18:58] Speaker 02:
And there's absolutely no mention of any special cooling equipment.

[00:19:02] Speaker 02:
that would be used because, in fact, it was conventional.

[00:19:06] Speaker 01:
Does it have to be mentioned?

[00:19:07] Speaker 01:
15 degrees is obviously below the normal environmental ambient temperature.

[00:19:15] Speaker 02:
And at 15 degrees, the cooling, if there were something that was unconventional about how one would do the cooling, the patent would be expected to say what you need to do.

[00:19:25] Speaker 02:
But because it's conventional to be able to cool to temperatures in this range, the patent doesn't mention it.

[00:19:32] Speaker 02:
And likewise, one skilled in the art wishing to follow the reference W0389,

[00:19:37] Speaker 02:
would also understand how to operate at 18 degrees.

[00:19:41] Speaker 02:
That's just simply something one's going to do.

[00:19:43] Speaker 04:
Your point is the prior art reference encompasses performing all these steps at 18 degrees Celsius.

[00:19:49] Speaker 02:
It explicitly teaches that.

[00:19:50] Speaker 02:
That's correct, Your Honor.

[00:19:53] Speaker 02:
And as to the point of Dr. Probitzian's testimony that was cited, Dr. Probitzian made quite clear, and this is at A946, that all materials would be equilibrated

[00:20:07] Speaker 02:
so that you would obtain robust data and in the end the reference explicitly teaches 18 to 25 and if the reference were in fact telling you to do something different which is no indication that it is.

[00:20:22] Speaker 02:
then everything would equilibrate, as the board found.

[00:20:26] Speaker 02:
There are, as was pointed out, three different wash steps that the reference teaches after you pour the fluid in.

[00:20:33] Speaker 02:
Before you actually elude out the purified material, there were three washes.

[00:20:38] Speaker 02:
So it's not as though the reference was teaching something that was instantaneous.

[00:20:43] Speaker 02:
As far as the obviousness is concerned, the motivations were well supported by the findings of the board.

[00:20:52] Speaker 02:
reduction of proteolysis there were teaching specifically in the prior art that protein A leakage in this sort of chromatography process was known and that decreasing temperature decreases proteolysis and that was at the pottier reference at appendix 592 and specifically at 594 to 95

[00:21:15] Speaker 02:
Dr. Prabitsian testified that one skilled in the art would know to balance the benefits of improving proteolysis against the costs that might be associated if cooling needed to occur.

[00:21:29] Speaker 02:
And the board credited Dr. Prabitsian's testimony on this point, on all of these points, at appendix 36 to 37 and also at appendix 30.

[00:21:39] Speaker 02:
There was some mention of a commercial process being the process where you might care more about controlling proteolysis.

[00:21:50] Speaker 02:
The claims themselves are not limited to a commercial process, of course.

[00:21:54] Speaker 02:
They're open to protein A chromatography generally.

[00:21:58] Speaker 02:
But there also was evidence at appendix 977 in particular that it was conventional and routine optimization to, in fact,

[00:22:07] Speaker 02:
cool in these larger processes.

[00:22:11] Speaker 01:
You think it would make a difference if the claims included a reference to the scale of the process?

[00:22:20] Speaker 02:
It would not in this case, Your Honor, because of the fact that it was not.

[00:22:24] Speaker 01:
Then why are you telling us you just said that it did, that the claims still cover a commercial process?

[00:22:30] Speaker 02:
The claims cover a commercial process, Your Honor, but they're not limited to a commercial process.

[00:22:35] Speaker 02:
And if the claim were limited... I wonder why that makes a difference.

[00:22:40] Speaker 02:
Because the claim covers both a lab scale process and a commercial process.

[00:22:46] Speaker 02:
Council's argument for non-obviousness, Your Honor, is directed to a commercial process itself.

[00:22:52] Speaker 02:
But in fact, the subject matter covers the non-commercial process.

[00:22:56] Speaker 02:
In fact, the board found that even in the commercial process, it was routine to do the cooling and specifically identified refrigeration of the fluid, jacket cooling, water baths, and cold rooms, and that's at appendix 977, which was credited by the board at appendix 39.

[00:23:17] Speaker 02:
Dr. Kramer, Genentech's expert, admitted that these techniques were in fact available in the art at Appendix 1080 and acknowledged that patent doesn't provide any specialized teaching of cooling because in fact that is something that is conventional even on a commercial scale process.

[00:23:34] Speaker 02:
And that's at Appendix 1081.

[00:23:37] Speaker 02:
On improving the binding capacity, the Van Someren reference teaches improving binding capacity by controlling temperature.

[00:23:47] Speaker 02:
board credits that testimony, and the argument from counsel is that there were later papers from Farner in 1999 and 2001 that somehow discredit

[00:24:02] Speaker 02:
the Van Someren teaching.

[00:24:03] Speaker 02:
In fact, those two papers do not discredit the Van Someren teaching.

[00:24:08] Speaker 02:
They specifically say that temperature control is one way of improving binding capacity.

[00:24:15] Speaker 02:
And that's at appendix 1294 and appendix 1312.

[00:24:20] Speaker 02:
And in fact, both of those papers cite the Van Someren paper approvingly.

[00:24:25] Speaker 02:
There's no criticism of the Van Sommeren teaching in these later papers.

[00:24:29] Speaker 02:
And so while obviousness must be measured, of course, at the time of the invention, at the time of the invention, what we had was a situation where Van Sommeren taught that temperature could improve binding capacity.

[00:24:42] Speaker 02:
And that was approvingly cited by the two Farner papers, which also listed other variables that could be controlled.

[00:24:50] Speaker 02:
And this court has made clear that simply listing multiple variables without criticizing any one particular approach does not constitute a teaching away.

[00:25:00] Speaker 02:
And so while there were multiple ways that one could improve binding capacity, the board was perfectly appropriately identifying that, in fact, binding capacity was something that could be improved and one skilled in the art would have been motivated to do so.

[00:25:15] Speaker 01:
You're not defending the plus or minus three degrees limitation construction, are you?

[00:25:25] Speaker 02:
On the plus or minus three degrees on the anticipation by Van Sommeren, the board's ruling was in fact correct.

[00:25:32] Speaker 02:
That's a very reasonable construction.

[00:25:34] Speaker 02:
And the board based that construction on the intrinsic evidence primarily.

[00:25:38] Speaker 02:
The board cited to the specification, which when controlling at 15 degrees, specifically cited plus or minus three degrees.

[00:25:48] Speaker 02:
And then the intrinsic prosecution history, there were amendments where the claim originally recited about 20 as the upper limit.

[00:25:57] Speaker 02:
There was a rejection over prior art reference that taught about 22.

[00:26:02] Speaker 02:
And ultimately, the claim was amended to the upper limit of about 18.

[00:26:06] Speaker 02:
And that was deemed to distinguish the reference.

[00:26:10] Speaker 02:
And in fact, in the European counterpart,

[00:26:13] Speaker 02:
patent application, the explicit statement was made that the reference to about 18 did not capture 22.

[00:26:24] Speaker 02:
And so the plus or minus 3 was both supported by the specification and the context of the prosecution history and certainly under a broadest reasonable construction standard ought to be affirmed here.

[00:26:39] Speaker 02:
I see that I've exceeded my time.

[00:26:41] Speaker 02:
Are there any other questions?

[00:26:43] Speaker 02:
Thank you.

[00:26:54] Speaker 00:
Thank you.

[00:26:55] Speaker 00:
Good morning.

[00:26:56] Speaker 05:
Will you hear from the PTO, and you're here to argue the retroactivity question?

[00:27:01] Speaker 00:
Yes, Your Honor.

[00:27:01] Speaker 00:
Of course, this court's.

[00:27:02] Speaker 05:
Which wasn't really raised.

[00:27:04] Speaker 00:
No, Your Honor.

[00:27:04] Speaker 00:
And of course, this court's opinion last week in Celgene forecloses of the Takings Clause challenge.

[00:27:09] Speaker 00:
This court held that retroactive IPRs is not an unconstitutional taking.

[00:27:13] Speaker 00:
The brief suggests, but does not really develop a separate argument under the due process clause.

[00:27:17] Speaker 00:
Of course, as Your Honor mentioned, they have not pressed that here today.

[00:27:20] Speaker 00:
To the extent that they do make a separate argument under the due process clause, Selden's discussion reasoning demonstrates why that argument is incorrect.

[00:27:28] Speaker 00:
Congress had a rational basis to apply IPRs to all patents in existence at the time.

[00:27:32] Speaker 00:
And that's all that's required to satisfy the due process clause.

[00:27:36] Speaker 00:
I'm happy to see the rest of my time, unless the Court has any other questions.

[00:27:41] Speaker 00:
Thank you.

[00:27:41] Speaker 00:
Thanks very much.

[00:28:00] Speaker 03:
I'd like to focus on three brief points in rebuttal.

[00:28:04] Speaker 03:
Council for Aspera cited the testimony of Dr. Kramer that he was unaware of any commercial process working in the way that we described the W0389 process.

[00:28:16] Speaker 03:
Of course, there's no discovery in a

[00:28:19] Speaker 03:
PTAB regarding commercial processes.

[00:28:21] Speaker 03:
And so he had no foundation on which to define one way or another.

[00:28:27] Speaker 03:
But we can look to Appendix 1733, which is the presentation that Genentech gave of this research at the American Chemical Society, where

[00:28:37] Speaker 03:
It's stated explicitly that the temperature of the culture fluid was about 25 to 30 degrees when loaded onto the protein A column.

[00:28:48] Speaker 03:
I think that disposes of that point.

[00:28:50] Speaker 03:
The presentation from which that citation comes, I think, looms large over this.

[00:28:57] Speaker 03:
PTAB discredited it, didn't give it much weight because of purported insufficient evidentiary development.

[00:29:05] Speaker 03:
But I think it's really important

[00:29:07] Speaker 03:
when this court considers the ultimate conclusion of obviousness, and specifically the conclusion that this work was routine.

[00:29:16] Speaker 03:
because that's the basis on which all the obviousness grounds rest.

[00:29:20] Speaker 03:
But this work was routine.

[00:29:22] Speaker 03:
The fact that in 2005 the American Chemical Society chose this research for presentation at its national meeting, I think objectively eviscerates that rationale.

[00:29:34] Speaker 03:
The American Chemical Society is not interested in hearing about routine research.

[00:29:40] Speaker 03:
Very briefly, then, the comment from Hasbira that the prior art publications approvingly cited Van Sommeren.

[00:29:52] Speaker 03:
That's not true.

[00:29:53] Speaker 03:
At Appendix 1312, when they cite Van Sommeren,

[00:29:56] Speaker 03:
the review proceeds to say, controlling temperature is a bad idea because it could affect product quality.

[00:30:03] Speaker 03:
So these are the variables to look at.

[00:30:05] Speaker 03:
And then lastly, we heard a citation to Appendix 977.

[00:30:09] Speaker 03:
That's the reply declaration of Hospira's expert.

[00:30:13] Speaker 03:
And I think if you read that paragraph, Hospira's expert disclaims any discussion of industrial scale purification, only talks about the ease of doing it at a lower scale.

[00:30:23] Speaker 03:
Where at 8, 13, 12 does it say?

[00:30:26] Speaker 03:
Stay away from temperature certainly honor 1312 It's the final sentence of the last complete paragraph in the second column it says while changes in pH buffer conductivity or temperature could denature precipitate or otherwise affect the antibody

[00:30:56] Speaker 03:
changing the flow rate and column length to optimize a bioprocess would have little impact on the antibody itself.

[00:31:05] Speaker 03:
The paper then proceeds to talk about optimizing these processes around flow rate and column length.

[00:31:16] Speaker 03:
That last point was simply the

[00:31:19] Speaker 03:
Claims are not limited to a commercial scale, but the motivation of the person of ordinary skill concerns commercial operations.

[00:31:29] Speaker 03:
That's why commercial scale is relevant to the analysis here.

[00:31:33] Speaker 03:
It's not a claim scope issue.

[00:31:35] Speaker 03:
It is all about the conclusion of obviousness and why the purpose of ordinary skill would have purportedly made the claim to mention.

[00:31:46] Speaker 05:
Thank you.

[00:31:46] Speaker 05:
Thank you.

[00:31:56] Speaker 05:
18-2003, Erickson versus TCL.