[00:00:01] Speaker 04:
The third case this morning is number 23, 1795, Dexcom, Inc.

[00:00:06] Speaker 04:
versus Abbott Diabetes Care, Inc.

[00:00:43] Speaker 04:
I'm sorry.

[00:00:45] Speaker 04:
23-15-40 as a Rudy Pharmaceuticals in versus Ikeen Laboratories.

[00:00:51] Speaker 04:
Mr. Kong?

[00:00:55] Speaker 00:
Correct, Your Honor.

[00:00:56] Speaker ?:
Okay.

[00:00:58] Speaker 00:
Thank you.

[00:00:59] Speaker 00:
Good morning, Your Honors, and may it please the Court.

[00:01:01] Speaker 00:
I heard reference to Dr. Constantinides in the previous case, and I thought for a moment I was late for my argument because he was one of the experts in our case as well.

[00:01:08] Speaker 00:
So we'll be hearing a lot about Dr. Constantinides during our argument today.

[00:01:12] Speaker 00:
So to start, the district court's determination of obviousness and lack of written description

[00:01:17] Speaker 00:
is erroneous for multiple reasons and we respectfully ask that it should be reversed.

[00:01:23] Speaker 00:
I'm going to start with written description.

[00:01:25] Speaker 00:
The district court committed a legal error by misinterpreting this court's prior authority regarding functional language that covers genus compounds.

[00:01:35] Speaker 00:
In those cases the concern is that the functional language covers thousands or millions or billions of compounds

[00:01:42] Speaker 00:
in part because those compounds have not been discovered and there's no adequate written description for those compounds in the specification.

[00:01:50] Speaker 00:
That's far afield from the narrow formulation claim that's at issue in this case.

[00:01:55] Speaker 00:
Here, the claims present no such concern.

[00:01:59] Speaker 00:
There is no chemical compound or undiscovered chemical compound that's perhaps within the grasp of the functional language that's at issue here.

[00:02:07] Speaker 00:
If we were to try to apply this genus species notion to our case, it seems that the species here would be parabens.

[00:02:15] Speaker 00:
And I'm going to start with what was known in the art about parabens and then turn up the specification.

[00:02:19] Speaker 01:
Can I ask you a couple of preliminary questions?

[00:02:21] Speaker 01:
I apologize, because you've already kind of jumped in.

[00:02:23] Speaker 01:
But I noticed your opening brief didn't have a summary of the argument as required by our rules.

[00:02:28] Speaker 01:
Is there a particular reason why it doesn't have?

[00:02:30] Speaker 00:
I apologize for that, Your Honor.

[00:02:32] Speaker 00:
You're right.

[00:02:33] Speaker 00:
In our mind, we thought that the introduction and the other aspects covered the summary of the argument.

[00:02:37] Speaker 00:
But upon reading the rules, I agree with Your Honor.

[00:02:39] Speaker 00:
It should have included a summary of the argument.

[00:02:41] Speaker 01:
But what it's worth, I find those very helpful often when I'm preparing.

[00:02:44] Speaker 00:
I apologize for that, Your Honor.

[00:02:45] Speaker 01:
The other thing is, on the bottom of the blue brief at page 14, there's a sentence that I don't think is accurate.

[00:02:53] Speaker 01:
And I just want to ask you about it.

[00:02:55] Speaker 01:
It says, the 747 patent claims required me in a tall.

[00:02:59] Speaker 01:
which the patent described as a stabilizing agent at least 50 times.

[00:03:04] Speaker 01:
I don't see it in there more than twice.

[00:03:06] Speaker 01:
And so I'm just wondering why it was stated that it was in there at least 50 times.

[00:03:11] Speaker 00:
I didn't prepare for that, Your Honor.

[00:03:14] Speaker 00:
I apologize.

[00:03:14] Speaker 00:
I trust your reading.

[00:03:15] Speaker 00:
If it's not in there 50 times, it's in there at least twice.

[00:03:18] Speaker 00:
And the important place where it's in there is the conclusion where it says that the use of Manitol as a stabilizing agent had produced better stability than the other stabilizing agents that were tested against it.

[00:03:32] Speaker 01:
Okay.

[00:03:34] Speaker 01:
Go ahead and proceed.

[00:03:35] Speaker 00:
Thank you.

[00:03:35] Speaker 00:
So turning back to the genus-species analysis, I think if I'm applying this correctly, the district court had in mind that here parabens are the species, and so in the prior art parabens were known.

[00:03:46] Speaker 00:
They were known to be a preservative.

[00:03:48] Speaker 00:
They were known to be used in liquid and alkyl formulations as a preservative.

[00:03:52] Speaker 00:
There was no concern presented about the use of them in that regard at all in the prior art.

[00:03:56] Speaker 00:
Turning to the specification, the specification identifies parabens specifically as an exemplary preservative.

[00:04:03] Speaker 00:
That's column 10 and columns 6 and 12.

[00:04:05] Speaker 00:
It identifies a paraben or a mixture of parabens as an embodiment of the invention.

[00:04:12] Speaker 00:
Columns 12 and 13 disclose exemplary amounts and concentrations of parabens.

[00:04:18] Speaker 00:
The examples use a paraben or a mixture of parabens as a preservative.

[00:04:24] Speaker 00:
And so based on what was known by the skilled reader, when the skilled reader reads this specification, they would see a correlation between the content, the expressed content of the specification and what appears in the claims themselves.

[00:04:39] Speaker 00:
And so there is adequate written description here.

[00:04:41] Speaker 00:
And what's frustrating about the district court's use of, for example, the Ariad case, which said specific examples are not required.

[00:04:50] Speaker 00:
the court used language from area to then draw the conclusion that we needed to disclose more we need to disclose a paraben example with data and that's exactly contrary to what this court found in area what about

[00:05:06] Speaker 00:
turning to obviousness.

[00:05:07] Speaker 00:
So I'm going to start with the buffer concentration limitation, Your Honor.

[00:05:11] Speaker 00:
And so the buffer concentration limitation, it was agreed at trial, Dr. Constantinides admitted, that in the prior art formulations regarding analepril,

[00:05:21] Speaker 00:
Buffer concentration was not disclosed.

[00:05:23] Speaker 00:
It was never discussed as being meaningful to stability.

[00:05:26] Speaker 00:
So to fill that hole in the evidence, what he said is he pointed to the de Villiers reference.

[00:05:31] Speaker 00:
De Villiers reference has nothing to do with enalapril.

[00:05:34] Speaker 00:
It just discusses how to create a buffer of a certain pH.

[00:05:39] Speaker 00:
And what Dr. Constantine said is when you take those buffer amounts, you just do calculations to arrive at what the claimed buffer concentration is.

[00:05:47] Speaker 00:
But when we look at davilier, what it says is the amounts of ingredients that it's suggesting 1L-skilling are used produce a buffer concentration that is 15 times higher

[00:05:59] Speaker 00:
than what is claimed in the history points so because of that there must be some evidence in the record that would motivate one of skill near to go from that highly elevated concentration down to the claim the buffer concentration and reduces fifteen fold there is no testimony on that whatsoever there's only testimony of continuity saying that would be an easy task will be routine if you if you know

[00:06:25] Speaker 04:
what the pH is that you're looking for.

[00:06:28] Speaker 04:
The testimony is that you could calculate the buffer concentration, correct?

[00:06:34] Speaker 00:
Correct.

[00:06:35] Speaker 00:
And you can calculate the buffer concentration.

[00:06:38] Speaker 00:
And indeed, de Villiers did that on the face of the reference.

[00:06:41] Speaker 00:
And it said the buffer concentration they're recommending is 15 times higher than what is claimed.

[00:06:47] Speaker 00:
So there must be motivation to move from what is in that reference

[00:06:52] Speaker 00:
to the claimed buffer concentration range.

[00:06:55] Speaker 00:
And generalized testimony, conclusory testimony regarding it's an easy task, or you just calculate it, or it's routine.

[00:07:02] Speaker 00:
It doesn't provide an articulated rationale behind that motivation.

[00:07:06] Speaker 00:
It doesn't provide any facts regarding why one of Skilner would be motivated to move to the claimed buffer concentration range.

[00:07:14] Speaker 04:
There's plenty of testimony from relying on Alan

[00:07:18] Speaker 04:
and El Amory about getting a pH range of about three, right?

[00:07:28] Speaker 00:
So that's pH range, not buffer concentration, your honor.

[00:07:30] Speaker 00:
Those are two separate limitations.

[00:07:31] Speaker 04:
OK, the buffer concentration and pH range are directly related, right?

[00:07:36] Speaker 00:
So to have a pH within a certain range, you need to have a certain buffer concentration.

[00:07:42] Speaker 00:
Yes, but it is a wide range of concentrations, of which we only claim a very small part of.

[00:07:47] Speaker 00:
So there must be some motivation for one of skill in the art to move from the de Villiers reference and the concentration there 15 fold down to what is in our claims in terms of buffer concentration.

[00:07:59] Speaker 00:
And that's just motivation, your honor, turning to reasonable expectation of success.

[00:08:03] Speaker 00:
Again, there must be some articulated reason why one of skill and the art would combine the claim buffer concentration with the remaining structural limitations in the claim and think that achieving the claim stability was reasonable.

[00:08:17] Speaker 00:
But there's no testimony.

[00:08:19] Speaker 00:
All there is is Constantinides saying it's an easy task, it's routine.

[00:08:23] Speaker 00:
And again, that generalized testimony is not sufficient

[00:08:27] Speaker 00:
in terms of obvious is there has to be an articulated rationale what else is wrong so i would then turn to even if we were set aside uh... it all the factual errors report out everything

[00:08:41] Speaker 00:
The district court summed up the evidence on obviousness as being, as providing a possibility that long-term stability could be achieved in an analog-pro formulation.

[00:08:52] Speaker 00:
So the sum of the evidence is at best a possibility or other place that the district court says it could be achieved.

[00:08:58] Speaker 00:
One of the skill networks thought it could be achieved.

[00:09:01] Speaker 00:
Elsewhere in the opinion, the district court uses the word hope.

[00:09:03] Speaker 00:
One of skill now would hope, based on the prior art, that this could be achieved.

[00:09:08] Speaker 04:
You would do this because it could produce a useful result.

[00:09:12] Speaker 04:
You have a reasonable expectation.

[00:09:15] Speaker 00:
Could and possible and hope is not a reasonable expectation.

[00:09:19] Speaker 00:
A possibility is not a reasonable expectation, your honor.

[00:09:22] Speaker 00:
I respectfully submit that's discussed in some of the prior cases where if you're talking about possibilities that doesn't rise to the level

[00:09:29] Speaker 00:
of an expectation of success.

[00:09:30] Speaker 04:
But the district court found reasonable expectation, right?

[00:09:35] Speaker 00:
In words, yes, but not in evidence.

[00:09:37] Speaker 00:
The evidence stacks up.

[00:09:38] Speaker 00:
The word could was used three or four or five times.

[00:09:41] Speaker 00:
The word possible was used.

[00:09:42] Speaker 00:
The word hope was used.

[00:09:43] Speaker 00:
That was the summation of the evidence by the district court.

[00:09:46] Speaker 00:
That does not rise the level of the reasonable expectation of success.

[00:09:50] Speaker 04:
Could you show me the language that you're objecting to?

[00:10:10] Speaker 00:
So I would start with Appendix 27.

[00:10:14] Speaker 00:
Well, let me skip ahead.

[00:10:19] Speaker 00:
The word could appears in the bottom paragraph of 27.

[00:10:21] Speaker 00:
But I'll start at 20, Appendix 30.

[00:10:23] Speaker 00:
And it's a follow-on sentence.

[00:10:25] Speaker 00:
And it says, Dr. Constantini is replying that these studies would have given a post of confidence that long-term stability was possible.

[00:10:35] Speaker 00:
Not that it was reasonably expected, but that it was only possible.

[00:10:38] Speaker 00:
Then we go to the next paragraph on Appendix 30.

[00:10:41] Speaker 00:
That's where the word hope appears.

[00:10:42] Speaker 00:
It's four lines down on the left.

[00:10:44] Speaker 00:
It says, it would give a post a hope that a high level of stability required by the claims could be achieved.

[00:10:51] Speaker 00:
So hope and could and possible, and there are other instances of could on the next page.

[00:10:56] Speaker 00:
On Appendix 31, it says, believing that long-term stability was achievable.

[00:11:01] Speaker 00:
Believing that it was achievable.

[00:11:03] Speaker 00:
That doesn't give a reasonable expectation of success.

[00:11:07] Speaker 00:
Believing something to be achievable, thinking something is possible.

[00:11:10] Speaker 02:
You're not arguing that he's applying a wrong legal standard.

[00:11:13] Speaker 00:
No, he applied the correct legal standard.

[00:11:15] Speaker 02:
What I'm saying is that the evidence... You're just fiddling with his work choice of... If he had put expectation in every time he said, oh, then it would be okay.

[00:11:26] Speaker 00:
I think that's right, yeah.

[00:11:28] Speaker 00:
But he chose the word.

[00:11:29] Speaker 02:
But that sounds like a legal argument, not a factual argument.

[00:11:32] Speaker 02:
He knows what legal standard he has to make, and he's making factual findings that presumably he intends to satisfy this legal standard.

[00:11:42] Speaker 00:
Possibly that was the intent here.

[00:11:44] Speaker 00:
The legal standard, I agree, is set forth correctly in the opinion.

[00:11:47] Speaker 00:
The factual findings, summarized by the district court as could and possible and achievable, that does not meet the required standard of reasonable expectation of success.

[00:11:57] Speaker 02:
It just feels like you're quibbling with his word choice because I guarantee you, if we sent this back and said, hope is not good enough, he's going to issue an opinion that replaces every word, one of those words with reasonable expectation.

[00:12:12] Speaker 00:
And that might be true, your honor.

[00:12:14] Speaker 00:
And that's why I think remand here is appropriate because as I pointed out on buffer concentration, there is no articulated reason on motivation or reasonable expectation when it comes to buffer concentration.

[00:12:24] Speaker 00:
And so you're right, remand for that might just get bounced back here, and I'll be making the same argument using different terms.

[00:12:29] Speaker 00:
But there is a clear hole in the evidence when it comes to obviousness.

[00:12:33] Speaker 00:
And the buffer concentration limitation is one of those places where it is very, very clear that Constantinides did not provide any facts, any reasoned articulation that would motivate one of skill in the R or lead them to expect success with the claim buffer concentration.

[00:12:49] Speaker 04:
OK, so what else is wrong with the district?

[00:12:51] Speaker 00:
So the other thing that stands out, Your Honor, is the district court's use of the Al-Omari document as prior art.

[00:13:00] Speaker 00:
That document was never identified by any party as being relevant to obviousness.

[00:13:04] Speaker 00:
It was not identified as prior art.

[00:13:05] Speaker 00:
It did not appear on a Section 282 notice.

[00:13:08] Speaker 00:
The only time that we as Ernie were aware that Al-Omari was being used as a prior art reference was in the post-trial opinion.

[00:13:16] Speaker 00:
That's the very first time it was ever used as a prior art reference.

[00:13:20] Speaker 00:
So there's notice issues, there's prejudice issues.

[00:13:22] Speaker 00:
And I think it's a pretty remarkable thing for the court to do, especially when at the pretrial conference, I did make a point to make sure that the prior art references discussed in the expert reports were the only ones we were dealing with.

[00:13:34] Speaker 00:
And the district court agreed with me.

[00:13:36] Speaker 04:
The district court relied on Allen, right?

[00:13:38] Speaker 00:
The district court did rely on Allen as well for the statement regarding pH?

[00:13:42] Speaker 00:
Is that where your honor's going?

[00:13:43] Speaker 04:
Yeah.

[00:13:44] Speaker 00:
So the statement regarding pH?

[00:13:46] Speaker 00:
Yes, that statement appears in Allen.

[00:13:47] Speaker 00:
There's a footnote associated with it.

[00:13:50] Speaker 04:
The district court interpreted that reference to the Merck index as not having to do with pH.

[00:13:58] Speaker 00:
And one of Skill in the Art, and this is testified to by Dr. Constantinides, one of Skill in the Art, when they see that statement in Allen, would confirm it by looking at the footnoted reference.

[00:14:09] Speaker 00:
and when it meant it was going to have looked at mark incisive seeing nothing in there about the issue court said it wasn't the reference wasn't about the age and i think that's the problem wants to know what corroboration for that statement and i'll get out and study that subject so without any collaboration reference other ph studies right this just relying on the work index for whatever it's wrong for that statement regarding the maximum stability of an hour pro

[00:14:39] Speaker 00:
at a pH of about three, that was citing to the Merck index, very clearly.

[00:14:43] Speaker 04:
It was not the only site, right?

[00:14:45] Speaker 00:
No, that was the only site.

[00:14:47] Speaker 00:
For that sentence, that's the only footnote, Your Honor.

[00:14:53] Speaker 04:
In the following pages, it refers to other pH studies.

[00:14:57] Speaker 00:
There are sentences that discuss other studies that are not footnoted.

[00:15:02] Speaker 00:
A discussion of other studies, yes, some of those studies involved smaller amounts of enalpril, but no details regarding the formulation at all.

[00:15:11] Speaker 04:
Okay.

[00:15:12] Speaker 04:
You want to save the rest of your time?

[00:15:13] Speaker 04:
Certainly, your honor.

[00:15:15] Speaker 04:
Mr. Prats.

[00:15:22] Speaker ?:
Thank you.

[00:15:24] Speaker 03:
Take one more sip of water.

[00:15:30] Speaker 03:
I haven't spoken in a while.

[00:15:33] Speaker 03:
May it please the court.

[00:15:35] Speaker 03:
I'd like to start first with the written description.

[00:15:39] Speaker 03:
I think that

[00:15:40] Speaker 03:
Mr. Kong gives a pretty short shrift description of one of the cases and tries to describe the case as requiring some sort of genus species analysis.

[00:15:53] Speaker 03:
And that's just not the laws that's developed in the federal circuit.

[00:15:57] Speaker 01:
Can I start by asking you a written description question, actually, on this topic?

[00:16:00] Speaker 01:
Because I'm having a hard time.

[00:16:02] Speaker 01:
I'm looking at column 18, line 64, to column 19, line 2.

[00:16:08] Speaker 01:
and I'm having a hard time understanding why that isn't providing sufficient written description support.

[00:16:14] Speaker 03:
And the reason is because the claims are functional claims.

[00:16:19] Speaker 01:
The claims are not just... If you look at the part that I was citing to, I mean, that part I'm citing to refers, addresses the functional limitation in the claim.

[00:16:33] Speaker 01:
And so I'm having a hard time understanding why it's not satisfied.

[00:16:37] Speaker 01:
It says, it talks about stability for at least 12 months.

[00:16:42] Speaker 01:
It says that the liquid formulations described herein are stable for at least 12 months.

[00:16:50] Speaker 03:
With respect to the paraben formulations, they have nothing.

[00:16:57] Speaker 01:
So if you don't think that the specification when it says oral liquid formulation is described herein, it's not including the paraben formulations, why not?

[00:17:06] Speaker 03:
It doesn't, for two reasons.

[00:17:08] Speaker 01:
One is they didn't do anything to confirm that the paraben formulations could have any stability whatsoever, because they didn't possess... Okay, you're saying there's no examples, but now there's case law that very clearly says, Ariad, says you don't have to have examples.

[00:17:25] Speaker 01:
You're just looking at a written description.

[00:17:27] Speaker 01:
It seems to me you're arguing enablement.

[00:17:30] Speaker 01:
You're arguing that it wouldn't be capable of satisfying the functional limitation.

[00:17:37] Speaker 01:
No, actually, I think they... Don't interrupt me, please.

[00:17:41] Speaker 01:
I apologize.

[00:17:42] Speaker 01:
before corners of the document doesn't say that it does though.

[00:17:46] Speaker 01:
Those are two different things.

[00:17:48] Speaker 01:
And I'm giving you my question because I want to hear your best response.

[00:17:51] Speaker 03:
I think they can improve enablement.

[00:17:53] Speaker 03:
I don't think they have written description for the reason that they did not possess the invention that involved parabens.

[00:18:02] Speaker 03:
They actually disclaimed it.

[00:18:04] Speaker 03:
And because they don't have any statements in there that a paraben formulation could meet those functional claims.

[00:18:12] Speaker 01:
So in your view, it's not sufficient that it says, the formulations described herein are stable four and then in the refrigerated condition.

[00:18:23] Speaker 01:
that somehow I'm supposed to read that as meaning only some of the formulations satisfy or intended to satisfy the functional language.

[00:18:32] Speaker 03:
Because that's all they really invented.

[00:18:33] Speaker 01:
Because there's no example.

[00:18:35] Speaker 01:
What is your argument besides the fact that there's no example?

[00:18:39] Speaker 03:
There could be other things in there.

[00:18:41] Speaker 03:
I don't know, but they don't have anything.

[00:18:44] Speaker 03:
And with the inventor testimony, which is relevant to distinguish what isn't invented, under the Nouveau Farms case,

[00:18:53] Speaker 03:
They expressly said they didn't do it.

[00:18:56] Speaker 01:
I thought that what he said was that in regards to enablement, a person of ordinary skill in the art would be able to perform the stability tests with the paraben formulation and show that it satisfied the 12 months.

[00:19:12] Speaker 01:
I thought that's what he said, and I think that's an admission that there's no written description, which presents a completely different question.

[00:19:20] Speaker 03:
says that there's no written description, where he says, I don't possess this invention.

[00:19:25] Speaker 03:
He says that they didn't.

[00:19:27] Speaker 01:
Where does he say, I don't possess this invention?

[00:19:29] Speaker 01:
There's no written description.

[00:19:31] Speaker 03:
He quite clearly says it with respect to the single-paraben formulation, which is claimed in those claims.

[00:19:37] Speaker 01:
Well, you want to give me an appendix, say?

[00:19:39] Speaker 04:
Yeah.

[00:19:42] Speaker 04:
You're just saying one parabens isn't enough.

[00:19:45] Speaker 04:
He says that I don't think it would work using a single-paraben.

[00:19:49] Speaker 01:
Yeah.

[00:19:50] Speaker 01:
But that's not what's claimed, right?

[00:19:51] Speaker 03:
So I didn't do it.

[00:19:53] Speaker 03:
And that was his explanation for not doing it.

[00:19:56] Speaker 03:
But yet they claim it.

[00:19:58] Speaker 03:
They quite clearly claim a single paraben formulation.

[00:20:01] Speaker 03:
He says that...

[00:20:31] Speaker 03:
It's Appendix 2986, where he says that he would not do it.

[00:20:38] Speaker 03:
He had no expectation that pyrimine could be substituted for sodium benzoate.

[00:20:44] Speaker 03:
Now, they invented the sodium benzoate formulation.

[00:20:47] Speaker 03:
They probably enabled

[00:20:48] Speaker 03:
other formulations because it is a matter of routine experimentation.

[00:20:52] Speaker 03:
It is a matter of ultimately what ultimately becomes obvious to be able to do this.

[00:20:58] Speaker 03:
You just tinker with it and you come up with it.

[00:21:00] Speaker 03:
But they didn't do it with single paraben, yet they claim it all.

[00:21:03] Speaker 03:
And that's what the problem that the court had with this is that they did not claim or they're claiming too much.

[00:21:10] Speaker 03:
They don't practice this invention, these claims.

[00:21:13] Speaker 03:
They never invented it.

[00:21:15] Speaker 03:
They never put it together.

[00:21:16] Speaker 03:
They never

[00:21:17] Speaker 03:
Uh, never tested it.

[00:21:18] Speaker 04:
Don't have any information.

[00:21:23] Speaker 04:
Let's move on to obviousness.

[00:21:26] Speaker 04:
Okay.

[00:21:26] Speaker 04:
And you've heard.

[00:21:27] Speaker 03:
There's a scattered shot.

[00:21:29] Speaker 04:
Mr. Conn's three or four points about the opinion.

[00:21:35] Speaker 04:
Could you address those points?

[00:21:36] Speaker 03:
I'll address each one as we talk about it.

[00:21:38] Speaker 03:
It's from a broad observation standpoint.

[00:21:41] Speaker 03:
I want to say that the judge absolutely knew... Let's skip the broad observations and go on to the specific objection.

[00:21:49] Speaker 03:
Okay.

[00:21:50] Speaker 03:
So the buffer concentration, he relies on Dr. Little or Dr. Konstantinidis, who testified that this is a matter of routine experimentation.

[00:21:59] Speaker 03:
It could be optimized quite easily.

[00:22:01] Speaker 03:
Dr. Constantinitis refers to deviliers as an example of this ability to testify.

[00:22:09] Speaker 03:
There's some tables in deviliers that they take issues to, but deviliers itself also says you could dilute it.

[00:22:16] Speaker 03:
And so it's a matter of simply figuring out what to do.

[00:22:19] Speaker 03:
Importantly, Dr. Little, their experts, says nothing about buffer concentration.

[00:22:24] Speaker 03:
They're not talking about this as a novel part of this invention at all.

[00:22:28] Speaker 03:
They just said, well, you didn't check off that box, but we did.

[00:22:33] Speaker 03:
And the court

[00:22:35] Speaker 03:
applying the correct standards, listened to Dr. Constantinitis, and believed it.

[00:22:40] Speaker 03:
They don't like that that's what happened here.

[00:22:43] Speaker 03:
And the credibility determinations between these two experts is such that Judge Goldberg agreed with our expert that this was a matter of routine experimentation and it would be easily done.

[00:22:55] Speaker 03:
And that's a common theme.

[00:22:57] Speaker 03:
That's why I wanted to start with a common theme.

[00:22:58] Speaker 03:
But particularly with respect to the buffer concentration, you don't have to find the specific thing in the art.

[00:23:06] Speaker 03:
All of these things, all of the ingredients, the functionality of this invention are all found in the prior art.

[00:23:12] Speaker 03:
It's all agreed to.

[00:23:12] Speaker 03:
And the question is, how easy would it be to put together?

[00:23:16] Speaker 03:
And Dr. Kentzitz and I is quite clearly testified.

[00:23:20] Speaker 03:
And the court quite clearly absorbed the fact that this would be something that would be easy.

[00:23:24] Speaker 03:
Easy to do.

[00:23:25] Speaker 03:
And in fact, they rely on that for enablement because this isn't part of the invention.

[00:23:30] Speaker 03:
This isn't what they did.

[00:23:32] Speaker 03:
What about the reliance on Al Amari?

[00:23:35] Speaker 03:
Al Amari, first of all, was entered into evidence without any objection whatsoever.

[00:23:39] Speaker 03:
It was introduced during our case on non-infringement.

[00:23:45] Speaker 03:
It was described and it was introduced on non-infringement.

[00:23:49] Speaker 03:
The court does refer to Alamari in the obviousness section.

[00:23:54] Speaker 03:
It is prior art.

[00:23:56] Speaker 03:
It was produced to them in the case, so their idea that they're surprised by this is unavailing.

[00:24:03] Speaker 03:
And the fact is that it wasn't the only reference that was used to put the point.

[00:24:08] Speaker 03:
because Alan was used in the pH, and Dr. Kinsettinitis testified in general with respect to the art, and also with respect to the court picked up with what Alamari talked about.

[00:24:21] Speaker 03:
And it's not an error to use this as an unobjected piece of prior art.

[00:24:28] Speaker 03:
And if you look at where the court referred to Alamari, time and again, he's talking about background art, what was generally understood by a person with ordinary skill in art.

[00:24:38] Speaker 03:
So there's not air for them to accept this as evidence.

[00:24:41] Speaker 03:
It was introduced as evidence without objection.

[00:24:43] Speaker 03:
It's not air for them, for the court, to refer to Alamari as part of the fabric of what was known because Dr. Kancitonitis quite clearly testified as to what was known in the art and how easy it would be to put together.

[00:24:58] Speaker 03:
Okay, how about the footnote to the Merck reference?

[00:25:02] Speaker 03:
So, that's with respect to the Allen reference.

[00:25:05] Speaker 03:
The Allen reference states that the Antilapril is most stable at the particular pH level, but the sentence contained other pieces of information about Antilapril.

[00:25:18] Speaker 03:
The footnote, which referenced the Merck index, was referenced for the other pieces of information in that sentence.

[00:25:27] Speaker 03:
And so it's not an error to cite the footnote.

[00:25:31] Speaker 03:
So it wasn't a typographical error, it wasn't an error, but it's a statement that was in the Allen reference as to the stability of the drug at the particular pH.

[00:25:42] Speaker 03:
Allen is a peer-reviewed article and it was admitted into evidence and it was relied upon by all of the experts in this case.

[00:25:51] Speaker 03:
The court can refer to the body of the thing.

[00:25:55] Speaker 03:
They're trying to impose some sort of standard that it has to be supported by the footnote, where it just doesn't.

[00:26:01] Speaker 03:
The fact is that that Allen reference says that it was most stable at 3.2, and Dr. Kansenides testified as to what would have posed to do with that.

[00:26:12] Speaker 03:
And so they would say, I'd target 3.2.

[00:26:14] Speaker 03:
Well, that's a pretty obvious thing to do.

[00:26:16] Speaker 03:
And the fact that it was easy to do goes on and on, and it makes the invention.

[00:26:21] Speaker 03:
But the fact is that the Merck index doesn't support that particular part of the sentence, and this is what Goldberg explained, so this wasn't something that he misunderstood.

[00:26:32] Speaker 03:
He quite clearly understood that the footnote doesn't refer to the 3.2, it refers to other parts.

[00:26:39] Speaker 03:
of the sentence.

[00:26:40] Speaker 03:
This is like little pieces that they try to pick apart in what Judge Goldberg did overall.

[00:26:47] Speaker 03:
What he did overall was look, he did what you're supposed to do.

[00:26:50] Speaker 03:
You look at all of the art, look at for all of its teachings, and you look at the combinations of the art and to find out if this would be easy to do or not.

[00:27:00] Speaker 03:
And the fact is that time and again, Judge Goldberg

[00:27:03] Speaker 03:
believed Dr. Tancitinitis over Dr. Little, who was found to overemphasize certain things and to put too much emphasis on something else, and was ultimately discredited with respect to the balancing that is being done at the trial court level as to whether or not there's going to be a reasonable expectation of success that you're going to end up with this invention.

[00:27:27] Speaker 03:
And the fact is they don't like the result.

[00:27:30] Speaker 03:
But the fact is Judge Goldberg did exactly what he's supposed to do.

[00:27:33] Speaker 03:
But he also judged the credibility of the witnesses.

[00:27:37] Speaker 03:
He listened to all the testimony.

[00:27:39] Speaker 03:
He read all of the documents in this case.

[00:27:43] Speaker 03:
And he did the analysis he was supposed to do.

[00:27:46] Speaker 03:
And they take issue with it because they don't like the result.

[00:27:48] Speaker 03:
But the fact is, there wasn't any legal error to be involved here.

[00:27:52] Speaker 03:
And to substitute, at this stage, the credibility determinations, the factual determinations that Judge Goldberg brought to the trial and did this now, that would be uncalled for.

[00:28:08] Speaker 03:
I think that covered all of the different pieces that he had.

[00:28:11] Speaker 03:
The briefs have, I have a stack of like eight or nine different things, and he went to a few of them.

[00:28:17] Speaker 03:
I think I've covered them all, but if the court has any further questions.

[00:28:23] Speaker 03:
Thank you.

[00:28:23] Speaker 03:
Thank you.

[00:28:27] Speaker 04:
Just give me about a couple of minutes.

[00:28:29] Speaker 00:
Thank you, Your Honor.

[00:28:30] Speaker 00:
I'll be quick.

[00:28:31] Speaker 00:
On inventor testimony and written description, the testimony that counsel refers to had to do... You should have two minutes.

[00:28:38] Speaker 00:
has to do with the question, if you swapped out the preservative in the brand name eponet product with a single paraben, would it pass an AET test, which is an FDA test that they impose for approval?

[00:28:49] Speaker 00:
That was the question.

[00:28:49] Speaker 00:
It had nothing to do with the written description.

[00:28:51] Speaker 00:
It had nothing to do with can you use it for purposes of this invention?

[00:28:53] Speaker 00:
It was focused on the brand product.

[00:28:55] Speaker 00:
I want to go back to your honor's point about Alan and the discussion of the Merck reference.

[00:29:00] Speaker 00:
So let's accept the statement in Alan on his face that a pH of three is where an Alpril is maximally stable.

[00:29:05] Speaker 00:
When you look at the data in ALLEN, it actually contradicts it, because Dr. Constantinides said that the pH 4.7 and 4.8 formulation had better stability than the pH 3.7 in ALLEN itself.

[00:29:18] Speaker 00:
And there's other examples of that in the ARC.

[00:29:20] Speaker 00:
Look at the CASAS reference.

[00:29:21] Speaker 00:
A pH of 3 there led the formulation to crash in stability at 90 days.

[00:29:26] Speaker 00:
You compare that with the NAHATA reference, which put enalpril in water, pH 7.1, the stability of that formulation is actually better than the CASAS formulation.

[00:29:35] Speaker 00:
So even if there's that one statement, unsupported statement in ALLEN, there's data all over the prior ARP that teaches against it that says that pH, it might be important, but there's other things going on here as well.

[00:29:48] Speaker 00:
Now I want to refer the report to tables A and B in the specification.

[00:29:52] Speaker 00:
This is where the patent shows that buffer concentration is indeed meaningful and important to stability.

[00:29:58] Speaker 00:
It compares different buffer concentrations at similar pHs, and it shows that buffer concentrations within the claimed range have better

[00:30:05] Speaker 00:
stability.

[00:30:06] Speaker 00:
So the court's point about how a pH of three would be the north star for any formula they're looking at that completely misses that point and ignores the buffer concentration limitation, which is important here as explained in the patent and is explained by Dr. Little at trial.

[00:30:23] Speaker 00:
He said that Dr. Little didn't have anything to say about buffer concentration.

[00:30:27] Speaker 00:
That's because Dr. Constantinides didn't provide any actual, sensitive testimony about it.

[00:30:33] Speaker 00:
He just, again, said, calculated reasonable, I'm sorry, routine experimentation.

[00:30:39] Speaker 00:
Those generalities and conclusions, there's no evidence, there's no rationale regarding either motivation or reasonable expectation when it comes to buffer concentration.

[00:30:48] Speaker 04:
Thank you, Mr. Hunter.

[00:30:49] Speaker 04:
Thank you, counsel.

[00:30:50] Speaker 04:
The case is submitted.