[00:00:00] Speaker 01:
1547, Eli Lilly and Company against Los Angeles Biomedical.

[00:00:07] Speaker 00:
On this appeal, Your Honors, there are three reasons why the PTAB

[00:00:18] Speaker 00:
should be reversed to find that Whitaker is anticipatory.

[00:00:22] Speaker 00:
Firstly, if you look at the complaint and the other judicial admissions from LA Biomed and the related district court case, there's no space between those allegations of LA Biomed and what Whitaker teaches.

[00:00:36] Speaker 00:
And if you take those as admissions of a party opponent, those admissions that one's daily

[00:00:44] Speaker 00:
arrest and regress fibrosis means likewise that Whitaker's identical teaching of the same one step, take it daily, necessarily anticipates.

[00:00:54] Speaker 00:
The second reason is that the board recognized that the disclosure of Whitaker of a period as long as the patient suffers from erectile dysfunction, they recognized the meaning of that as being months if not longer.

[00:01:07] Speaker 00:
And they made a legal error though by taking that separate teaching of

[00:01:13] Speaker 00:
as long as the patient suffers, and bundling it together with multiple other embodiments, three-day and example six, to ask the question of inherency.

[00:01:21] Speaker 00:
Is there inherent teaching of greater than 45 days?

[00:01:25] Speaker 00:
When the record shows that as long as the patient suffers is an express teaching of that, and you can't undermine one express teaching by pointing to other teachings that may or may not be anticipatory.

[00:01:36] Speaker 00:
And so that was legal error by the board.

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The third reason is that if, as LA Biomint asserts,

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the PTAB didn't really find that as long as the patient suffers means months, then the final written decision would lack substantial evidence because there's one and only one meaning on the record of what as long as the patient suffers means.

[00:02:00] Speaker 00:
So regarding the first point on the judicial admissions, what LA Biomement asserted in its complaint in the related district court case at appendix page 5807, they asserted that

[00:02:12] Speaker 00:
by instructing physicians in the quote, once daily, close quote, use of Cialis to treat ED, really has been and is currently actively inducing and encouraging infringement of at least one claim of the 903 patent.

[00:02:26] Speaker 00:
So instructing someone to take Chidallophilus, the active ingredient Cialis, is, according to LA Biomed, an active infringement, or results in an active infringement.

[00:02:37] Speaker 00:
Whitaker, as we know, as Judge Bryson pointed out,

[00:02:42] Speaker 00:
repeatedly said on, now we're in different appendix number, but Whitaker, page 7, appendix 748, repeatedly teaches daily treatment.

[00:02:53] Speaker 00:
And so taking what they said as true for this case, that daily Tidalofil, daily Cialis, results in infringement, Whitaker's identical teaching of daily Tidalofil must be anticipatory.

[00:03:11] Speaker 00:
As far as the duration, what LA Biomed asserted at appendix page 7763 in their infringement contentions is they recognize that the Cialis label also doesn't say not less than 45 days.

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It just says take daily without any other statement about the duration.

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And so what they said is that the Cialis label does not state any limitation on the duration of the administration.

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of Cialis for once daily use for erectile dysfunction.

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And they relied on the absence of an endpoint as evidence of infringing at least 45 days.

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They likewise relied on disclosure on the Cialis label, again, page 7763, that there were long-term clinical trials greater than 45 days.

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And they relied on that piece of evidence of long-term clinical trials

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as evidence that Cialis once daily is taught for an extended period of time.

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But as we saw from example six of Whitaker, Whitaker also supports his teachings with long-term clinical trials.

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And so there's no way for L.A.

[00:04:24] Speaker 00:
Biomem to be able to assert, as they have, that once daily Tadalafel without a specific end time is infringing without it also being anticipatory.

[00:04:39] Speaker 03:
Let's try and go through this.

[00:04:41] Speaker 03:
So on the page of Whitaker where it suggests day or daily, it says still more preferably one time for 24-hour period.

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I think that's clearly daily.

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But then it says preferably for three or more days.

[00:04:56] Speaker 03:
That suggests a relatively short period of time.

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And then in that same sentence, it says and still more preferably daily as long as the patient suffers from erectile dysfunction in the absence of therapy.

[00:05:09] Speaker 03:
The board looked at this and it concluded, and I have to review for substantial evidence, that this did not disclose daily, continuously, every day for 45 days.

[00:05:21] Speaker 00:
What they concluded is that it was not an inherent teaching of at least 45 days.

[00:05:26] Speaker 03:
Well, they also concluded it wasn't an express teaching.

[00:05:28] Speaker 00:
I don't think so, Your Honor.

[00:05:29] Speaker 03:
Really?

[00:05:29] Speaker 03:
Because how in the world could they conclude there's no anticipation here if I don't read their opinion as concluding there's no express teaching?

[00:05:35] Speaker 00:
Because they literally said

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Therefore, there's no inherent anticipation.

[00:05:41] Speaker 00:
They literally only addressed inherent anticipation, Your Honor.

[00:05:44] Speaker 03:
No, they said, you argue, and they quote from your brief, that as long as the patient suffers, means daily dosing for 45 days.

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And then they say at the end of the paragraph, we are not persuaded.

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So they expressly quote from the petitioner's brief and then say, we are not persuaded.

[00:06:06] Speaker 03:
I think that looks to me like they're concluding it's not expressly, because the part they quote from you is Whitaker expressly teaches a much longer treatment period.

[00:06:17] Speaker 03:
This is your brief that they're quoting from and then they end by saying we're not persuaded.

[00:06:21] Speaker 00:
Right.

[00:06:21] Speaker 00:
And then the analysis they go through on appendix page nine in the middle of the page, they say although the ordinary artisan may have understood that patients may suffer from rectal dysfunction for months if not longer, that best is an obviousness argument.

[00:06:36] Speaker 00:
That argument, the argument relying on as long as, is not sufficient to demonstrate by ponderance of the evidence an inherent description of a continuous administration for at least 45 days.

[00:06:47] Speaker 03:
Where are you reading from now?

[00:06:48] Speaker 00:
In the middle of appendix page 9, Your Honor.

[00:06:52] Speaker 00:
It says just almost exactly at the middle on the right-hand side.

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After the we are not persuaded part.

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This is the next paragraph after they said we are not persuaded.

[00:07:02] Speaker 00:
Correct.

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And their legal analysis is a lack of inherency.

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And they say it's not an inherent description, especially in view of Whitaker's teaching that a therapeuticly effective period may be as short as three days.

[00:07:14] Speaker 00:
They're considering the teachings together for inherency, and it's the only thing they evaluated it for.

[00:07:20] Speaker 03:
At the end of that paragraph, it says, therefore, we determine petitioner is not demonstrated by preponderance the evidence that Whitaker anticipates claim one.

[00:07:28] Speaker 03:
Are you really of the belief that the board misunderstands whether they're supposed to look at whether the reference expressly discloses an element, that that is somehow something that the Patent Office fails to appreciate about their job?

[00:07:43] Speaker 03:
Even though you say it expressly teaches it and they say we are not persuaded, I should not read that as them finding it doesn't expressly teaching and then the next paragraph reaching whether it nonetheless inherently teaches, I shouldn't read the opinion that way.

[00:07:58] Speaker 03:
I should instead read it as they misunderstood that their job was to decide whether it expressly teaches it or not.

[00:08:04] Speaker 00:
Your Honor, the only analysis they provide, you're right they say we're not persuaded, the only analysis they provide

[00:08:09] Speaker 00:
is an inherency analysis.

[00:08:11] Speaker 03:
They say we're not persuaded right after expressed, noting that you are arguing it's expressly taught by the very language that you're telling us it is.

[00:08:17] Speaker 00:
And the reason they indicate for not being persuaded is a lack of inherent disclosure.

[00:08:21] Speaker 03:
OK.

[00:08:21] Speaker 03:
So suppose that I actually read the board's opinion as a fact finding that it doesn't expressly teach that.

[00:08:28] Speaker 03:
Why don't you start from that point?

[00:08:29] Speaker 03:
Because I don't think you're going to get me.

[00:08:31] Speaker 03:
That's fine.

[00:08:33] Speaker 03:
That doesn't end your argument, so let's go there.

[00:08:38] Speaker 03:
Nothing probably does, I'm sure, but go ahead.

[00:08:42] Speaker 00:
The duration from Whitaker, there's only one meaning on the record for what as long as the patient suffers means.

[00:08:51] Speaker 00:
And the only meaning on the record for what as long as the patient suffers means is that it's months.

[00:08:59] Speaker 00:
There's testimony from Dr. Bivalakwa on that point.

[00:09:03] Speaker 00:
Well, no.

[00:09:03] Speaker 04:
Your poser counsel quarreled with your reading of Dr. Bivalakwa's testimony on the ground that he wasn't talking about this issue.

[00:09:12] Speaker 04:
OK.

[00:09:12] Speaker 04:
Well, I think that... I haven't read the entire context.

[00:09:16] Speaker 04:
In fact, I don't think the appendix contained the entire context of Dr. Bivalakwa's statement.

[00:09:20] Speaker 04:
But could you fill us in on that?

[00:09:22] Speaker 00:
Sure.

[00:09:23] Speaker 00:
So we asked Dr. Bivalakwa how long it would take to resolve erectile dysfunction.

[00:09:28] Speaker 00:
And he said,

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And I'm paraphrasing, not quoting, but he said, through exercise, et cetera, or lifestyle changes, it would take at least months.

[00:09:37] Speaker 00:
Now, L.A.

[00:09:38] Speaker 00:
Bobbin... He wasn't talking about drug therapy.

[00:09:41] Speaker 00:
Well, I'm going to address that.

[00:09:42] Speaker 00:
Go ahead.

[00:09:43] Speaker 00:
L.A.

[00:09:43] Speaker 00:
Bobbin is coming back and saying that he wasn't addressing drug therapy.

[00:09:48] Speaker 00:
He didn't expressly address drug therapy.

[00:09:50] Speaker 00:
It's true.

[00:09:51] Speaker 00:
But their arguments kind of run into themselves here.

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If you look at page 16 of their brief in this case,

[00:09:58] Speaker 00:
They are arguing that Whitaker does not teach and would not be understood to be a therapeutic treatment of erectile dysfunction.

[00:10:06] Speaker 00:
They say Whitaker simply teaches relief from erectile dysfunction symptoms.

[00:10:11] Speaker 00:
And so what LA Biomement is elsewhere arguing is that you pick up Whitaker and you read it as pure symptomatic treatment.

[00:10:19] Speaker 00:
Now they want to say that there could have been pharmaceutical intervention.

[00:10:22] Speaker 00:
There was no treatment.

[00:10:24] Speaker 00:
They're claiming to be the first treatment that is curing erectile dysfunction.

[00:10:28] Speaker 00:
And so if you read Whitaker as symptomatic relief only, then the earliest, as long as the patient suffers from erectile dysfunction could be, is months, if not longer, due to lifestyle changes.

[00:10:42] Speaker 00:
Because there is, according to LA Biomed, in the prior art, no teaching and no disclosure anywhere of a curative treatment.

[00:10:54] Speaker 00:
So if the board didn't find, as

[00:10:58] Speaker 00:
long as the patient suffers from rectal dysfunction to be an inherent disclosure.

[00:11:03] Speaker 00:
As we said, that lacks substantial evidence, because there's only one meaning in the record.

[00:11:08] Speaker 00:
There's no meaning.

[00:11:09] Speaker 00:
There's no meaning from Dr. Bivalakos saying it means something else.

[00:11:11] Speaker 00:
They're putting a qualifier on it.

[00:11:13] Speaker 00:
The qualifier doesn't really hold water.

[00:11:15] Speaker 00:
But there's no meaning to someone other than that it would be months.

[00:11:20] Speaker 00:
And the testimony, for example, from Dr. Goldstein in the appendix, page 7207, is reading Whitaker, he says,

[00:11:29] Speaker 00:
I would write a prescription for daily Tadalafel to cover six months.

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And that's what he would do.

[00:11:35] Speaker 00:
And then at appendix page 7204, in the middle of paragraph 114, Whitaker's treatment for these patients would likewise be at least months, if not years, or daily as long as the patient suffers from erectile dysfunction.

[00:11:57] Speaker 00:
7204 to 7205 in paragraph 115.

[00:12:01] Speaker 00:
Dr. Goldstein again explains why it would be at least months if not longer.

[00:12:05] Speaker 00:
Dr. Bivalakwa's testimony where he says, I would expect it to take months is on page 7527.

[00:12:14] Speaker 00:
And so there's only one meaning to what as long as can mean on the record.

[00:12:19] Speaker 00:
And that meaning of months

[00:12:22] Speaker 00:
falls within the scope of not less than 45 days.

[00:12:25] Speaker 00:
So that's why that's taught.

[00:12:26] Speaker 00:
And if the board either didn't recognize that or didn't make that finding, it erred.

[00:12:55] Speaker 04:
Unless there are other questions.

[00:12:56] Speaker 04:
I have a question.

[00:13:01] Speaker 04:
Suppose you have, here's what's troubling me about the anticipation argument.

[00:13:06] Speaker 04:
And I give it to you in the form of an example.

[00:13:09] Speaker 04:
Suppose you have Sudafed, which is treatment for the symptoms of a common cold, which can last anywhere from a few days up to, let's say, three weeks.

[00:13:20] Speaker 04:
And someone discovers that a treatment

[00:13:25] Speaker 04:
of the amount of pseudodefinite, which I guess is the active ingredient, given daily for 18 days or more will actually cure pneumonia discovered.

[00:13:42] Speaker 04:
Is that invention anticipated by the label on pseudofed that says you can take it for as long as the cold lasts?

[00:13:52] Speaker 00:
No, it wouldn't be because you don't have the right population.

[00:13:55] Speaker 00:
You don't have a population that necessarily has pneumonia.

[00:13:58] Speaker 00:
But in Whitaker, to follow your analogy, the Whitaker patients have pneumonia.

[00:14:03] Speaker 04:
The Whitaker patients do, but not necessarily all the people that would be covered if you assume that the patent covers anybody with ED.

[00:14:14] Speaker 00:
Right.

[00:14:14] Speaker 00:
But Whitaker is more specific to, in your example, pneumonia.

[00:14:19] Speaker 00:
than the label.

[00:14:20] Speaker 00:
The label says a cold generally or cough generally, IED.

[00:14:24] Speaker 00:
Whitaker is narrower and more specific to the population, that it's a population that has circulatory dysfunction due to atherosclerosis, et cetera.

[00:14:33] Speaker 00:
And so the anticipation is even more clear in view of their admissions in the district court case, because Whitaker teaches a specific patient population, IE patients with ED due to circulatory dysfunction resulting from

[00:14:49] Speaker 00:
catheter sclerosis or diabetes.

[00:14:52] Speaker 01:
So are you saying the answer to Judge Bryson's question depends on how it's claimed?

[00:14:58] Speaker 01:
If you say I have a method of curing pneumonia by treatment with something that hasn't previously been used to cure pneumonia, that's limited to curing pneumonia and would not capture the other uses of Sudafed.

[00:15:15] Speaker 01:
One of the things that seems to be troubling here

[00:15:19] Speaker 01:
is that it does look as if something has been discovered about fibrosis for ailments other than ED, but that the claims are not specific.

[00:15:34] Speaker 01:
And in your raising the issues of anticipation as well, we have claims that are sufficiently broad, perhaps, that on the standard criteria, that to anticipate

[00:15:48] Speaker 01:
You have to do everything that's in the claim.

[00:15:52] Speaker 01:
And here the claims are broad enough intentionally to affect fibrosis from any cause.

[00:16:02] Speaker 01:
So this perhaps is, whether it's a matter of claim drafting or whether it's something that can't be avoided, is something that I've been wrestling with.

[00:16:14] Speaker 01:
There's no way of writing a claim that's directed specifically

[00:16:19] Speaker 01:
to, let's say, atherosclerosis or something for which these products haven't previously been used.

[00:16:26] Speaker 01:
I think that's easy, but I gather that's not the question before us.

[00:16:30] Speaker 00:
I believe the question before us is, is Whittaker's treatment of patients with fibrosis, with ED due to circulatory dysfunction on a daily basis, not as long as the patient suffers, is that a species within what they're trying to claim?

[00:16:49] Speaker 00:
And it is.

[00:16:50] Speaker 00:
And we know that because that's what they assert below.

[00:16:53] Speaker 00:
They assert that a much broader activity of merely prescribing Cialis without any specific population would be infringing.

[00:17:02] Speaker 00:
Here we have Whitaker teaching to a specific fibrotic population.

[00:17:08] Speaker 00:
And we dispute the idea that there was any invention here at all, because Whitaker taught, take it daily to provide a continuous level near plasma of the drug

[00:17:18] Speaker 00:
to provide more than just symptomatic relief.

[00:17:20] Speaker 00:
He expressly distinguished it from on-demand therapy, which is one of LA Biomed's big theories, that they're the only ones to distinguish between on-demand therapy.

[00:17:30] Speaker 00:
Whitaker expressly teaches that as well.

[00:17:33] Speaker 00:
And Whitaker, likewise, we know is going to result in the arresting or regressing, because LA Biomed said that the same lower doses of Tadalafel will do that.

[00:17:43] Speaker 00:
And where in Whitaker, again,

[00:17:46] Speaker 04:
bring us back to Whitaker.

[00:17:48] Speaker 04:
Where does it disclose that the treatment is limited to this patient population, the fibrotic, aging, diabetic population?

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

[00:18:04] Speaker 00:
On page, Whitaker page 13, which is appendix 6754, they're explaining their understanding of why

[00:18:12] Speaker 00:
they see this vascular conditioning effect.

[00:18:14] Speaker 00:
And they're explaining why do we see this vascular conditioning effect.

[00:18:18] Speaker 00:
And they say we think it's because there's reversal of penile circulatory dysfunction that arose from atherosclerosis or diabetes.

[00:18:27] Speaker 00:
And so what that means is that if you want to apply Whitaker, you're not going to apply it to a patient who has ED due to some injury, some traumatic injury.

[00:18:38] Speaker 00:
You're going to apply it to a patient who has ED due to

[00:18:41] Speaker 00:
atherosclerosis or diabetes.

[00:18:43] Speaker 04:
So you're reading in effect backwards from this description of the hypothesized biology of the operation of this treatment to the patient group

[00:18:56] Speaker 04:
that is the subject, ultimately, of this method of treatment.

[00:19:00] Speaker 00:
Right.

[00:19:00] Speaker 00:
Their teaching is that it's working in these patients.

[00:19:03] Speaker 00:
Here's why it's working in these patients.

[00:19:05] Speaker 00:
So that's clearly the type of patients you want to administer it to, not some other category of patients who have ED due to psychological reasons or something else.

[00:19:14] Speaker 04:
And you say that that lines up well with the definition of the patient group in the claim.

[00:19:21] Speaker 00:
It includes this CBOD, this cavernosal

[00:19:27] Speaker 00:
fibrosis that is included in the same thing.

[00:19:30] Speaker 00:
Exactly.

[00:19:32] Speaker 00:
Exactly the same thing.

[00:19:35] Speaker 01:
Let's hear from the other side and we'll save you rebuttal time.

[00:19:37] Speaker 00:
Thank you.

[00:19:48] Speaker 01:
Ms.

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

[00:19:56] Speaker 02:
May it please the court, the board correctly determined that Whitaker does not anticipate the claims of the 903 patent.

[00:20:03] Speaker 02:
The board's decision has a single basis, namely that Whitaker does not teach a treatment duration of at least 45 days.

[00:20:11] Speaker 02:
That is correct.

[00:20:12] Speaker 02:
Whitaker also does not teach the remaining claim limitations, administering a PD-5 inhibitor according to a continuous long-term regimen to individuals with penile fibrosis,

[00:20:24] Speaker 02:
under arresting or regressing that fibrosis.

[00:20:27] Speaker 02:
So council has made two main arguments here today regarding why the board's ruling should be overturned based on Whitaker's teaching that administration be daily for as long as a patient suffers from erectile dysfunction and also that LA biomed's infringement positions are somehow an admission of anticipation.

[00:20:51] Speaker 02:
Turning first to what happened in district court.

[00:20:55] Speaker 02:
So LA Biomed accuses Lilly of inducing infringement of the 903 patent by instructing on the use of a drug called once daily Cialis.

[00:21:06] Speaker 02:
Those instructions are not prior art and arguments about infringement based on those instructions for use of once daily Cialis are not admissions for the purpose of Whitaker, which is a different reference.

[00:21:21] Speaker 02:
So the principle of that which would literally infringe if later in time anticipates it earlier applies when you have the exact same product or method being accused of infringement also being publicly available before the invention date.

[00:21:37] Speaker 02:
The once daily Cialis product label and Whitaker are not coextensive.

[00:21:43] Speaker 02:
So Whitaker discloses chronic administration of a family of PDE5 inhibitors

[00:21:48] Speaker 02:
It indicates that their full benefit is available after three days.

[00:21:54] Speaker 02:
For once daily Cialis, however, Lilly instructs users to take one tablet of Tadalafel specifically at approximately the same time every day.

[00:22:04] Speaker 02:
And unlike Whitaker, those instructions for once daily Cialis also contemplate that it will be administered to patients with penile fibrosis

[00:22:14] Speaker 02:
including specifically those with cavernosal fibrosis or Peyronie's disease.

[00:22:22] Speaker 02:
Nor is there any inconsistency between LA Biomed's claim construction positions for validity and infringement.

[00:22:29] Speaker 02:
Both require that the PDE5 inhibitor be administered for at least 45 days and that there also be arrest or regression of penile fibrosis.

[00:22:43] Speaker 02:
Turning to

[00:22:45] Speaker 02:
45 days, and the statement in Whitaker that a PD-5 inhibitor should be preferably administered daily for as long as the patient suffers from erectile dysfunction in the absence of therapy, Lilly argues on appeal that that is an explicit disclosure of treatment for at least 45 days.

[00:23:03] Speaker 02:
So Lilly does not argue that the limitation is inherently disclosed, and its argument for explicit disclosure fails for both substantive and procedural reasons.

[00:23:14] Speaker 02:
So substantively, there are a number of holes in Lily's argument.

[00:23:19] Speaker 02:
First, there simply was no finding of fact by the board that this statement in Whitaker means months were longer.

[00:23:26] Speaker 02:
The board simply summarized Lily's argument and then indicated it was not persuaded on pages eight and nine of the board's decision.

[00:23:37] Speaker 02:
Nor would such a finding have been supported by substantial evidence.

[00:23:42] Speaker 02:
Daily for as long as the patient suffers for erectile dysfunction teaches nothing about the duration of treatment for penile fibrosis.

[00:23:50] Speaker 02:
It simply means take the drug for as long as you need it.

[00:23:54] Speaker 02:
And that's not a teaching of a specific time period.

[00:23:59] Speaker 02:
Nor does that reference to daily somehow teach duration.

[00:24:04] Speaker 02:
Again, daily is an interval.

[00:24:07] Speaker 02:
It's not how many times and how long.

[00:24:11] Speaker 04:
But what about the argument that evidence such as Dr. Goldstein's testimony would indicate that a person with skill in the art would understand that as long as you need it for a patient in this patient class would be for a period of months, if not years.

[00:24:31] Speaker 02:
Right.

[00:24:31] Speaker 02:
So Dr. Goldstein has offered only his own unsupported testimony.

[00:24:36] Speaker 02:
He doesn't cite... He's an expert in the field.

[00:24:38] Speaker 02:
He is an expert in the field, but he also admitted that Whitaker's findings are new, that they had never been found before, and that there's no underlying data in Whitaker to support them.

[00:24:52] Speaker 02:
And so there's nothing for him to base his assessment of duration on.

[00:24:57] Speaker 02:
So the only thing, other thing he refers to was Dr. Bibulakwa's testimony during deposition.

[00:25:04] Speaker 02:
And again, Dr. Bivalakwa was asked how long it would take to resolve ED through things like diet or exercise or quitting smoking.

[00:25:13] Speaker 02:
And that simply bears no relevance to how long Whitaker's administration would take.

[00:25:26] Speaker 02:
Procedurally, Lilly also failed to point to this portion of Whitaker daily as long as the patient suffers from erectile dysfunction in its petition.

[00:25:35] Speaker 02:
And as the petitioner, it was required by 35 USC 312A3 to cite the specific portions of Whitaker that it alleges teach the claim limitations.

[00:25:49] Speaker 02:
It wasn't until LA Biomed pointed to, I apologize,

[00:25:54] Speaker 02:
What Lilly relied on in its petition, exclusively, was example six for the teaching of 45 days or more.

[00:26:00] Speaker 02:
And so it wasn't until after LA Biomed pointed to the flaws in example six in its patent owner response that Lilly came back on reply, changed its argument, and pointed now to this different portion of Whitaker.

[00:26:12] Speaker 02:
And having not identified that teaching in Whitaker in its petition, it was foreclosed from using it in the reply.

[00:26:20] Speaker 02:
And therefore, it should not be a basis for reversal on appeal either.

[00:26:26] Speaker 02:
As for example six, the board's finding that this portion of Whitaker does not teach at least 45 days is supported by substantial evidence.

[00:26:36] Speaker 02:
The trials described in example six were of eight or 12 weeks.

[00:26:40] Speaker 02:
But there's simply no evidence that any of the study subjects in those trials took the study drug for 45 consecutive days.

[00:26:49] Speaker 02:
Example 6 even puts daily in quote marks, acknowledging that the patients in that example were not dosing the drugs every single day, and nor has Lily argued on appeal that example 6 teaches 45 days.

[00:27:17] Speaker 02:
There was also a question earlier about the patient population that Whitaker teaches.

[00:27:22] Speaker 02:
Again, properly construed, an individual with at least one of a penile tunical fibrosis and corporal tissue fibrosis requires that an individual actually have penile fibrosis.

[00:27:33] Speaker 02:
But that's not the population that Whitaker teaches giving PDE-5 inhibitors to.

[00:27:39] Speaker 02:
Whitaker describes itself as useful for the treatment of sexual dysfunction.

[00:27:44] Speaker 02:
and especially erectile dysfunction.

[00:27:46] Speaker 02:
You can find that in the abstract.

[00:27:49] Speaker 02:
The examples in Whitaker describe men who have mild to moderate ED with little or no restriction as to the etiology.

[00:27:58] Speaker 02:
Whitaker does not even use the word fibrosis.

[00:28:07] Speaker 02:
Council pointed to the teaching in Whitaker of vascular conditioning.

[00:28:13] Speaker 02:
But even the Whitaker inventors don't rely on that teaching.

[00:28:17] Speaker 02:
They say it's theorized but not relied on.

[00:28:21] Speaker 02:
Under star scientific, that is not a teaching for the purpose of obviousness.

[00:28:27] Speaker 02:
And even Dr. Goldstein, Lilly's expert, has admitted that a person of skill in the art would not know what vascular conditioning is, and again, that Whitaker has no data to support it.

[00:28:46] Speaker 02:
The other argument that Lilly made in briefing for reversal was that the board failed to consider all of the evidence.

[00:28:54] Speaker 02:
To put that into context, Lilly had filed more than 40 entirely new exhibits in conjunction with its reply brief.

[00:29:02] Speaker 02:
And LA Biomed had sought to exclude about 21 of those and portions of Dr. Goldstein's reply declaration and Dr. Bivalakwa's deposition testimony.

[00:29:14] Speaker 02:
And the board ultimately denied that motion as moot because it indicated that it did not rely on the challenged evidence in its final written decision.

[00:29:26] Speaker 02:
Of the challenged exhibits, however, Lilly only relied on two for the 45-day issue, which is the only issue addressed by the board in its final written decision.

[00:29:37] Speaker 02:
And those two exhibits were four paragraphs from Dr. Goldstein's reply declaration and

[00:29:43] Speaker 02:
a small portion of Dr. Bivalakwa's deposition testimony.

[00:29:47] Speaker 02:
And remand to consider that evidence is only appropriate if there's prejudice to Lily, and here there is none.

[00:29:55] Speaker 02:
So that evidence relates to the same issue we've been discussing, which is the statement in Whitaker, as long as the patient suffers from erectile dysfunction.

[00:30:05] Speaker 02:
The board indicated that even if it were to accept that argument, it was not persuaded.

[00:30:09] Speaker 02:
It's an issue that Lily waived.

[00:30:12] Speaker 02:
And it's duplicative of testimony that Dr. Goldstein gave in deposition that was otherwise before the board.

[00:30:21] Speaker 02:
And the only other evidence that Lilly has raised as improperly excluded is Dr. Bivalakwa's testimony regarding what makes the claims novel.

[00:30:31] Speaker 02:
So Lilly argues that Dr. Bivalakwa conceded anticipation because he stated that the only point of novelty in the claims was the biological mechanism.

[00:30:41] Speaker 02:
And clearly, that's not what the claims are drafted to.

[00:30:44] Speaker 02:
And it's also not what Dr. Bivalok would testify if you look at that passage.

[00:30:50] Speaker 02:
He says something very different.

[00:30:54] Speaker 02:
Are there any further questions?

[00:30:57] Speaker 02:
No questions.

[00:30:58] Speaker 01:
Thank you.

[00:31:00] Speaker 01:
We'll hear from Mr. Feldman.

[00:31:09] Speaker 00:
So starting

[00:31:11] Speaker 00:
with one of the points that Ellie Bywood's counsel just made about that there's no prejudice to Lilly.

[00:31:18] Speaker 00:
If the board found by excluding evidence that Lilly had proffered in favor of anticipation, if the board found in our favor but didn't rely on all of our evidence, that of course would not be prejudicial to us.

[00:31:30] Speaker 00:
But what they did is they found against Lilly without relying on Lilly's evidence, without disputing Lilly's evidence, without addressing all of Lilly's evidence.

[00:31:39] Speaker 00:
And so especially if you read the board's decision, as LA Biomed does, that there was not a finding that as long as the patient suffers means months, then Lilly was clearly prejudiced because there's voluminous evidence in that record that that is the meaning of that as long as the patient suffers means at least months.

[00:32:01] Speaker 00:
And so by not making a finding, as LA Biomed contends,

[00:32:06] Speaker 00:
that as long as the patient suffers means months, and also not considering our evidence, that was prejudicial error by the board in ignoring evidence that supports our position.

[00:32:17] Speaker 00:
And the question of substantial evidence, there is only one meaning on the record of what as long as the patient suffers means.

[00:32:25] Speaker 00:
As Your Honor Judge Bryson pointed out, Dr. Goldstein testifies extensively on what it means, and that is undisputed.

[00:32:35] Speaker 00:
They didn't cross him to say that's not what it means.

[00:32:38] Speaker 00:
Dr. Vivalakwa didn't offer a different meaning.

[00:32:40] Speaker 00:
In fact, his meaning is consistent with it.

[00:32:43] Speaker 00:
And so you need to look at what a reference means through the eyes of a person of ordinary skill.

[00:32:48] Speaker 00:
There's only one meaning on the record.

[00:32:51] Speaker 00:
Any conclusion that there was no finding that as long as the patient suffers, it means at least months, could not be supported by substantial evidence, because there's only one meaning on the record.

[00:33:03] Speaker 00:
LA Biomed.

[00:33:05] Speaker 00:
argues that we shouldn't even be arguing about this, because Lily somehow waived that portion of Whitaker.

[00:33:12] Speaker 00:
And so, of course, the petition in this case relied on anticipation by Whitaker.

[00:33:18] Speaker 00:
It wasn't limited to example six.

[00:33:21] Speaker 00:
And Dr. Goldstein's petition, so for example, appendix page 251, the petition straightforwardly says that Whitaker anticipates.

[00:33:30] Speaker 00:
In appendix page 5042, which is the Goldstein declaration filed with the petition, he relies on example six, but he says Whitaker including example six.

[00:33:39] Speaker 00:
He's never limited to example six.

[00:33:42] Speaker 00:
The standard just after briefing was completed, perhaps the day after briefing was completed in this case, this court's opinion in genzyme therapeutic products versus biomerin, 825, F3RD,

[00:33:55] Speaker 00:
1360 came out, and it addressed the idea of when is a party below in the PTAB prejudiced by not being able to respond to an argument.

[00:34:04] Speaker 00:
And what Genzyme says is that if you had actual notice of the argument and opportunity to respond, then you're not prejudiced.

[00:34:13] Speaker 00:
And that's what happened here.

[00:34:14] Speaker 00:
Not only did that happen here, but L.A.

[00:34:17] Speaker 00:
Bauman made no express dispute before the board about this argument about

[00:34:24] Speaker 00:
as long as the patient suffers.

[00:34:26] Speaker 00:
And so they don't have a live dispute to maintain at the board, on appeal.

[00:34:32] Speaker 00:
And moreover, they did expressly address as long as.

[00:34:37] Speaker 00:
If you look in their patent owner response, which is appendix page 585, they specifically address the quote of daily as long as the patient suffers.

[00:34:46] Speaker 00:
In the Bivalock with declaration that was filed with their patent owner response, appendix page 8460

[00:34:53] Speaker 00:
Vivalaqua refers to daily as long as the patient suffers.

[00:34:57] Speaker 00:
And they admit that they questioned Dr. Goldstein at his deposition about it.

[00:35:03] Speaker 00:
They had actual notice and actually responded on the question of Whitaker's disclosure of daily as long as the patient suffers.

[00:35:12] Speaker 00:
And so there's no argument about Lilly having waved.

[00:35:16] Speaker 00:
The issue in fact is that LA Biomed doesn't have a live dispute before this board.

[00:35:21] Speaker 00:
that they were prejudiced by the board allowing that argument in.

[00:35:30] Speaker 00:
They refer to a bunch of Dr. Lee, LA biome.

[00:35:34] Speaker 00:
It refers to some deposition testimony from Dr. Goldstein that the exact meaning of vascular conditioning isn't specified and that there's no express data to support what vascular condition you're getting.

[00:35:47] Speaker 00:
And they provided that in argument

[00:35:50] Speaker 00:
in response to the question of what is as long as the patient suffers means.

[00:35:55] Speaker 00:
That's a complete non-secretary to refer to what is the meaning of vascular conditioning when the question is, what does a person understand daily as long as the patient suffers to mean?

[00:36:06] Speaker 00:
And again, there's only one meaning on the record.

[00:36:12] Speaker 00:
Thank you, Your Honor.

[00:36:13] Speaker 01:
Thank you.

[00:36:14] Speaker 01:
Thank you.

[00:36:14] Speaker 01:
Thank you both.

[00:36:15] Speaker 01:
We will take both of these cases under submission.