[00:00:23] Speaker 02:
Mr. Lombardi, please proceed.

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

[00:00:33] Speaker 00:
May I please record?

[00:00:35] Speaker 00:
This is an obviousness case where all aspects of the claimed invention were taught in the art.

[00:00:43] Speaker 00:
Both major components of the invention, the active ingredient testosterone and the penetration enhancer, were known and taught in the art.

[00:00:53] Speaker 00:
The need to combine testosterone with a penetration enhancer was known in the art.

[00:00:59] Speaker 00:
And the combination of all of these elements together was taught in the art.

[00:01:05] Speaker 06:
Can I just double check something?

[00:01:07] Speaker 06:
Correct me if I'm wrong.

[00:01:09] Speaker 06:
You don't make any argument that even if some of the claims are invalid for obviousness, others are not.

[00:01:17] Speaker 06:
That is, it's a single ball of wax for you on obviousness.

[00:01:21] Speaker 00:
It is.

[00:01:22] Speaker 00:
My opponent in the case calls out two particular claims to focus on other than the whole, and we do argue that those two claims and

[00:01:33] Speaker 00:
for the same reasons.

[00:01:35] Speaker 06:
But for example, you don't say, well, even if claim one is invalid for obviousness, nevertheless, some other ones survive, I'm assuming because you don't get anything out of that with your ANDA.

[00:01:47] Speaker 00:
Correct.

[00:01:48] Speaker 00:
Yes.

[00:01:48] Speaker 00:
And I misunderstood your question, Your Honor.

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

[00:01:51] Speaker 00:
We say that everything is obvious for essentially the same reasons.

[00:01:54] Speaker 00:
And as I say, there's some claims that our opponents treat differently and talk about differently.

[00:01:58] Speaker 00:
And we respond to that, but we think everything is up.

[00:02:01] Speaker 06:
And one other kind of, for me at least, housekeeping matter.

[00:02:04] Speaker 06:
Why does your infringement contention matter?

[00:02:07] Speaker 00:
It's a fair point, Your Honor, because in terms of our and as a practical matter, we have to win on obvious if that is true.

[00:02:14] Speaker 00:
We did think, and we did have this discussion, as you can imagine, we did think that the infringement situation

[00:02:20] Speaker 00:
where, in our view, the district court flipped the burden of proof and put it on us.

[00:02:25] Speaker 06:
Sort of an indication of general wrong-headedness?

[00:02:28] Speaker 00:
Well, no.

[00:02:29] Speaker 00:
It was an indication of something wrong that we thought it would be good to have court precedent on, that we thought it would be good to have this court speak on.

[00:02:39] Speaker 00:
I understand that's something that Your Honors, in your discretion, will decide whether to do or not.

[00:02:43] Speaker 00:
But we felt like it was an important enough issue, and that the district court had gotten it wrong, that we should be addressing it.

[00:02:50] Speaker 00:
The district court finding of obviousness here was made in spite of all those findings, all the findings the district court actually made that the elements are all in the art.

[00:03:02] Speaker 00:
And the district court specifically said, and I'm quoting at paragraph 136, said another way, the court finds that while the pieces of the patent and suit were known, their combinations and especially their specific ratios of the combination were not obvious.

[00:03:19] Speaker 00:
And so the district court wrote

[00:03:21] Speaker 00:
saw what it thought was a gap in the prior art in terms of the ratios of the combinations.

[00:03:26] Speaker 00:
And based on that gap concluded that this was not an obvious invention.

[00:03:32] Speaker 06:
So what, what, what is the best prior art that indicates taking the, since we just agreed, I think that you're doing obviousness as to all the claims as a single ball of wax that shows

[00:03:49] Speaker 06:
the full claimed penetration enhancer with the ranges of whatever the narrowest one is with testosterone I guess would be the best because part of at least the problem I've had here is that there's so much prior art I don't quite know where to look for the single cleanest

[00:04:14] Speaker 00:
Well, Your Honor, there are a few.

[00:04:17] Speaker 00:
And it's because this testosterone gel and penetration enhancers were thoroughly taught in the art.

[00:04:23] Speaker 00:
But in terms of prior art that actually has testosterone with the penetration enhancer, you could look at the specific claim penetration enhancer.

[00:04:34] Speaker 00:
Yes, the three components.

[00:04:36] Speaker 00:
It would be Patel, the 190 Patel reference.

[00:04:39] Speaker 00:
There are two Patel reference, but Patel 190.

[00:04:42] Speaker 00:
It would be Cooper, which was identified as the closest prior art in the patent office.

[00:04:49] Speaker 00:
You would also have, and those are the ones with testosterone specifically taught, but there are also pieces of prior art that have had the exact penetration enhancer that is taught as something that can be used with transdermal gels like this one.

[00:05:06] Speaker 00:
That would include Frank Kerr.

[00:05:08] Speaker 00:
which actually had the exact penetration enhancer, including the amounts in it, that would be Santa's, which had- Including, and when you say the amounts, you're making an assertion again about all of the claims now at issue?

[00:05:25] Speaker 00:
Well, Your Honor, there are claims.

[00:05:26] Speaker 00:
When I say the amounts, I guess to be- The narrowest claim.

[00:05:31] Speaker 00:
I'm sorry.

[00:05:31] Speaker 02:
You mean by the amount, you mean the narrowest claim.

[00:05:34] Speaker 00:
Yes.

[00:05:34] Speaker 02:
Let's be clear.

[00:05:35] Speaker 02:
claim 19 and 20 have no amounts of any kind for any of the penetration enhancers.

[00:05:42] Speaker 02:
It only, and this is of the 913 patent, it only has an amount for testosterone between 0.1 and 2%.

[00:05:46] Speaker 02:
So you can have any amount at any percentage of any of the others.

[00:05:52] Speaker 02:
So those claims, it seemed to me, would be the easiest for you to render obvious.

[00:05:58] Speaker 02:
But since you haven't separately argued them,

[00:06:01] Speaker 02:
Because, again, your ability to practice turns on killing all of them and not just some of them.

[00:06:07] Speaker 02:
You have to focus on, it seems to me, and unless your opposing counsel tells me I'm wrong, claim six of the 913 patent.

[00:06:16] Speaker 02:
Is it 913?

[00:06:17] Speaker 02:
No.

[00:06:18] Speaker 02:
865.

[00:06:19] Speaker 02:
Because that one narrows the oleic acid to between 0.1% and 5%.

[00:06:25] Speaker 02:
But it doesn't otherwise limit any other aspect of the penetration enhancers

[00:06:29] Speaker 02:
So the only limits provided by claim 6, unless I'm mistaken, are, since it depends on claim 1, the amount of testosterone, which would be limited to 0.1% to 2%, and then the amount of oleic acid, which would be 0.1% to 5%.

[00:06:43] Speaker 02:
Now, there is a claim 22.

[00:06:44] Speaker 02:
Now, again, that limits, as far as I can tell, the glycol to 30% to 40% by weight.

[00:06:53] Speaker 02:
That is not dependent on 6%.

[00:06:55] Speaker 02:
So you have claim 6.

[00:06:57] Speaker 02:
which limits only oleic acid and none of the other penetration enhancers.

[00:07:01] Speaker 02:
And you have claim 22, which limits only the amount of glycol and none of the other penetration enhancers.

[00:07:06] Speaker 02:
All those penetration enhancers are utilized in the composition, but there are no specific ranges given for any of them.

[00:07:13] Speaker 02:
Is my understanding of the claims correct?

[00:07:14] Speaker 00:
Yes, I think your understanding is correct, Your Honor.

[00:07:16] Speaker 00:
And so focusing on that, the amounts of oleic acid are clearly taught in Cooper.

[00:07:24] Speaker 06:
Which Cooper?

[00:07:24] Speaker 00:
In Cooper 934.

[00:07:27] Speaker 00:
And I'm referring to various examples, Your Honor, 11, 14, and 15, and also example 26.

[00:07:37] Speaker 02:
Now, because there was so much prior art, I have to admit to not having a perfect mastery of all of it, although I think I have Patel down really well.

[00:07:44] Speaker 02:
But my Patel was 970, so I was really surprised when you thought 190 was better.

[00:07:48] Speaker 02:
But nonetheless, 11, 14, and 15, you said it has the concentrations of oleic acid

[00:07:56] Speaker 02:
Does it also have, and it doesn't matter what amount, because the claims don't require what amount, but does it also include glycol?

[00:08:03] Speaker 02:
And does it also include an alcohol?

[00:08:06] Speaker 00:
I'm sorry, I missed which reference you were talking about.

[00:08:08] Speaker 00:
Cooper.

[00:08:08] Speaker 02:
You said Cooper 934, examples 11, 14, and 15 have the amount of oleic acid in the claimed range, 0.1% to 5%.

[00:08:17] Speaker 02:
My question to you is, do those examples employ the other two aspects of the penetration enhancer as well?

[00:08:23] Speaker 00:
It employs the aspects, but not the specific amount.

[00:08:25] Speaker 02:
So for instance, there is no specific amount specified by the claim.

[00:08:28] Speaker 00:
Well, in claim 22, if you're talking about claim 6, you're on your correct.

[00:08:34] Speaker 02:
Claim 6.

[00:08:34] Speaker 02:
Let's start with claim 6.

[00:08:35] Speaker 00:
Yes.

[00:08:35] Speaker 02:
So you're telling me Cooper has between 0.1% and 5% of oleic acid.

[00:08:40] Speaker 02:
It also employs alcohol and glycol.

[00:08:43] Speaker 02:
It doesn't matter what percentage, because for claim 6, that's irrelevant.

[00:08:46] Speaker 00:
That's correct, yeah.

[00:08:47] Speaker 02:
And the problem with Cooper, though, according to the district court, was it just lists male sex hormone in a long list of 50 different potential ailments slash active ingredients.

[00:09:00] Speaker 02:
And the district court's problem, as I understand it, was the predictability of choosing this particular

[00:09:06] Speaker 02:
composition of penetration enhancers and plugging it back into a given active ingredient.

[00:09:11] Speaker 02:
Is that right?

[00:09:12] Speaker 00:
That's correct and specifically the district court found that disclosing male sex hormone does not disclose testosterone.

[00:09:18] Speaker 02:
That's really curious to me because I'm a woman so maybe I'm a little daft when it comes to this.

[00:09:23] Speaker 02:
How many male sex hormones do people have?

[00:09:26] Speaker 00:
I can't tell you the amount but I can tell you that as a matter of record in this case testosterone is the most important and the primary male sex hormone.

[00:09:35] Speaker 00:
And I found that curious as well, Your Honor, because the entire argument or most of the argument related.

[00:09:40] Speaker 02:
OK, but so it's almost irrelevant, though, because even if I agreed with you that it's clearly erroneous for him to find that, which I don't know that I can on this record, because I don't see evidence that proves that male sex hormone is dispositively testosterone.

[00:09:55] Speaker 02:
But putting that aside, he gave a second reason, which is you can't just cherry pick one from this column and these from these columns.

[00:10:03] Speaker 02:
put them together, there's unpredictability in this art, we don't know it'll work.

[00:10:07] Speaker 02:
So what is your response?

[00:10:09] Speaker 00:
Well, my answer to that, Your Honor, is that there is art that teaches testosterone with the components of the penetration enhancer.

[00:10:16] Speaker 00:
When we get into the amounts of the penetration enhancer, our position is that as a matter of law, the court erred there.

[00:10:23] Speaker 00:
Because the patent teaches that a person of skill in the art

[00:10:26] Speaker 00:
could determine the appropriate amounts.

[00:10:28] Speaker 00:
The district court completely ignored that part of the patent.

[00:10:31] Speaker 00:
Our opponents never addressed it, and they haven't even addressed it in this appeal.

[00:10:35] Speaker 00:
So the patent says at column, I'm talking about the 913 patent right now, column three, line 63, the appropriate amounts or concentrations of the active agent, in this case testosterone, will be readily apparent to the skilled physician or the formulator preparing the formulation.

[00:10:54] Speaker 02:
As to the parts of the...

[00:10:56] Speaker 02:
I don't know that I've heard any dispute by anybody or even the district court about the range of the testosterone to be utilized.

[00:11:06] Speaker 02:
Am I mistaken on that?

[00:11:08] Speaker 00:
No, I don't think there is any dispute.

[00:11:10] Speaker 02:
So why don't you focus on where the dispute is.

[00:11:11] Speaker 00:
Then I'll take you to the same patent, the 913 patent, column 5, lines 31 to 34, which says the amount of the penetration enhancers will be readily apparent to those skilled in the arts.

[00:11:23] Speaker 00:
since the total amount of penetration enhancers will be approximately the same as those of the prior art.

[00:11:29] Speaker 00:
That's in the patent.

[00:11:30] Speaker 00:
And when a patentee makes assertions about the state of the art in a patent, they are binding on the patentee.

[00:11:37] Speaker 00:
And we cite Pharma STEM in other cases for that proposition.

[00:11:41] Speaker 00:
As I say, the district court never considered that.

[00:11:44] Speaker 05:
And so while the amounts- Is your view that there's a single reference that teaches the penetration enhancers

[00:11:51] Speaker 05:
putting aside amounts, because I think you're arguing that that's really irrelevant, with testosterone.

[00:11:58] Speaker 00:
Yes.

[00:11:59] Speaker 00:
Patel.

[00:12:01] Speaker 05:
If that's the case, why did you argue seven different references for obviousness?

[00:12:06] Speaker 05:
Why weren't you just arguing Patel?

[00:12:09] Speaker 00:
Well, Your Honor, because our attempt was to show that this is a very full art, and that this is not just taught just once.

[00:12:18] Speaker 00:
In obviousness cases, we frequently run into the idea

[00:12:21] Speaker 00:
that there's not that much in the art.

[00:12:25] Speaker 05:
This is an art where there is... It sure makes it seem less obvious to me if I have to look at seven different references instead of one or two.

[00:12:33] Speaker 00:
And I understand that, Your Honor.

[00:12:35] Speaker 00:
But I would say Patel 190 teaches all the elements.

[00:12:40] Speaker 00:
that Cooper teaches the elements and understanding Judge Moore's statement about the testosterone, that was an issue in the court.

[00:12:48] Speaker 00:
Frank Kerr teaches the precise penetration enhancer.

[00:12:52] Speaker 00:
It's a patent that goes to penetration enhancer.

[00:12:55] Speaker 00:
It teaches the precise penetration enhancers in the precise amounts in example 15.

[00:13:01] Speaker 00:
The only combination necessary was... But it's a different active ingredient.

[00:13:04] Speaker 00:
It was no active ingredient.

[00:13:06] Speaker 00:
In fact, I mean, in that example, there was a different active ingredient, but the gist of the patent was to penetration enhancer.

[00:13:12] Speaker 00:
And yes, there wasn't a teaching of testosterone specifically, but testosterone was taught to be a transdermal formulation that needed penetration enhancers.

[00:13:22] Speaker 00:
This penetration enhancer was called the most preferred in various pieces of art, more than one piece of art, in Santos,

[00:13:31] Speaker 00:
and in Frank Kerr.

[00:13:32] Speaker 02:
And so this- Why are you hung up on Patel 190 and not focusing on Patel 970?

[00:13:38] Speaker 02:
I'm confused about why you're so wedded to 190.

[00:13:44] Speaker 02:
You've got a clear error effect problem to overcome, which is what does GLY equal?

[00:13:50] Speaker 02:
And your expert said one thing, and what he said is apparently scientifically inaccurate.

[00:13:54] Speaker 02:
And the district court came out the other way on you on what it is.

[00:13:57] Speaker 02:
And that seems like something I'd have a hard time saying.

[00:14:00] Speaker 02:
It's clearly erroneous.

[00:14:01] Speaker 02:
So why?

[00:14:02] Speaker 02:
I mean, 970 doesn't have that problem.

[00:14:03] Speaker 02:
So why are you so focused on 190?

[00:14:05] Speaker 02:
What's so great about it?

[00:14:06] Speaker 00:
No, no, we can look at the 192.

[00:14:08] Speaker 00:
But may I just address the, sorry, Your Honor, the 970.

[00:14:12] Speaker 00:
But may I address the 190?

[00:14:14] Speaker 00:
The only evidence.

[00:14:15] Speaker 02:
You seem like it's a good use of your time, since your time is up.

[00:14:18] Speaker 02:
But I really need to.

[00:14:19] Speaker 02:
Go ahead.

[00:14:19] Speaker 00:
Well, the 970 gets you there, too, Your Honor.

[00:14:22] Speaker 00:
And the only thing to keep in mind with the 970

[00:14:25] Speaker 00:
The exact amounts aren't taught in the 970, but there is a teaching of a penetration enhancer that has probably... Wait, what do you mean the exact amounts aren't taught?

[00:14:36] Speaker 02:
Column 12 of the 970 says 5% oleic acid.

[00:14:40] Speaker 02:
and 95% glycol.

[00:14:43] Speaker 02:
That's the example in column 12.

[00:14:45] Speaker 02:
I mean, that seems to teach the amounts that fall right within the claim.

[00:14:48] Speaker 00:
That's not the same amount of propylene glycol as exists in the claim, for instance, claim 22.

[00:14:54] Speaker 02:
But that's a different claim.

[00:14:55] Speaker 02:
I'm talking about claim 6.

[00:14:56] Speaker 02:
The only claim that has an amount listed for oleic acid is claim 6.

[00:15:00] Speaker 02:
Claim 22 does not import that limitation in, correct?

[00:15:03] Speaker 00:
Correct.

[00:15:04] Speaker 02:
And for claim 6, why doesn't it die

[00:15:07] Speaker 02:
in light of the example in column 11.

[00:15:08] Speaker 00:
It does, Your Honor.

[00:15:09] Speaker 00:
And I'm sorry, I misunderstood the gist of your question.

[00:15:11] Speaker 06:
Which example precisely?

[00:15:13] Speaker 00:
The example in the 970 is at column 11, example Roman 2.

[00:15:21] Speaker 06:
Right, and it's at various test numbers.

[00:15:22] Speaker 06:
Which test number are you referring to?

[00:15:24] Speaker 00:
It's 2-D is the one that talks about PG is propylene glycol and OA is oleic acid.

[00:15:31] Speaker 02:
Well, even better than that one, what about the one in example 3, which also has oleic acid and the glycol?

[00:15:37] Speaker 02:
also at 5% and it is expressly utilizing testosterone as it says in the paragraph at the bottom.

[00:15:43] Speaker 02:
I don't know, the one in example two, it doesn't seem clear to me what the active ingredient is, but... 2D doesn't have ethanol in it, does it?

[00:15:51] Speaker 00:
2D does not recite ethanol.

[00:15:53] Speaker 06:
Okay, so it's not the same.

[00:15:55] Speaker 00:
Well, it's the same amount of oleic acid, which is what I understood Judge Moore to be asking about.

[00:15:59] Speaker 06:
Right, but this is not the, you know,

[00:16:02] Speaker 06:
Trifecta combination?

[00:16:03] Speaker 00:
No.

[00:16:04] Speaker 06:
Is the trifecta combination in one of these examples?

[00:16:07] Speaker 00:
The trifecta combination is not in Patel 970, but it is in Patel 190.

[00:16:14] Speaker 01:
Why would you say that?

[00:16:15] Speaker 01:
Did you not read the claims?

[00:16:17] Speaker 01:
Claim 39 is the trifecta.

[00:16:19] Speaker 00:
I'm sorry, Your Honor.

[00:16:20] Speaker 00:
I understood Judge Toronto to be asking me a different question, which is for the three elements.

[00:16:25] Speaker 00:
All three is what I understand.

[00:16:26] Speaker 01:
It's in the claims of Patel.

[00:16:29] Speaker 06:
You didn't point, unfortunately, as far as I can tell, to claim 39 in your brief, which is dependent on claim one to actually have the trifecta.

[00:16:43] Speaker 00:
Your Honor, I don't know if I have any time to reserve, but I will sit down and take a look at that and be prepared to respond.

[00:16:50] Speaker 00:
Thank you, Your Honor.

[00:16:51] Speaker 02:
All righty.

[00:16:53] Speaker 02:
Mr. Golov?

[00:16:55] Speaker 02:
Am I saying your name right?

[00:16:56] Speaker 02:
Golov.

[00:16:57] Speaker 02:
Thank you.

[00:16:58] Speaker 02:
Mr. Golub, please proceed.

[00:17:04] Speaker 03:
Well, Your Honor, if we turn to their obviousness case, this is the first time in three years we're hearing about any particular combination or any particular reference.

[00:17:15] Speaker 03:
All we've heard from them is that there is this bundle of prior art, and it's actually 10 references that they list.

[00:17:22] Speaker 03:
And they put testosterone in a specific

[00:17:26] Speaker 03:
combination with the penetration enhancers.

[00:17:30] Speaker 03:
But what they're saying is everything individually was known.

[00:17:32] Speaker 03:
They pointed to no prior art that had either testosterone with any kind of penetration enhancers.

[00:17:42] Speaker 03:
At the same time, this is a two-tiered analysis.

[00:17:46] Speaker 03:
The patent makes clear that when you're dealing with transdermal formulations for penetration enhancement, you have to consider irritation.

[00:17:55] Speaker 03:
The patent says it all through there and also... But the claims don't say it.

[00:17:59] Speaker 02:
The claim... And the claims, in fact, if you were to look at claim one of either patent, it has absolutely no limits at all on the concentrations of any of the penetration enhancing ingredients, does it?

[00:18:11] Speaker 03:
It does not.

[00:18:12] Speaker 02:
So how would that control for skin irritation?

[00:18:15] Speaker 02:
You don't have a limitation like a wherein clause, wherein the amounts are limited to avoid skin irritation that would cabin in the percentages even if you don't specifically list them.

[00:18:25] Speaker 02:
So how can you justify the non-obviousness of claim one?

[00:18:29] Speaker 03:
Well, the Supreme Court said in Adams that you are permitted to consider the objectives of the claimed invention from the specification to assess the prior art.

[00:18:41] Speaker 03:
This court did the same thing in DuPont in 1988 and held that Adams is proper when you are considering rebuttal to an obviousness assertion.

[00:18:51] Speaker 03:
So the court is permitted, which is what the district court did,

[00:18:54] Speaker 03:
is take into account that all through the patent, it relates to penetration and skin irritation.

[00:19:02] Speaker 03:
And when you look at Patel, the Patel that he's talking about, the 970, you see that when you just put two of them together.

[00:19:10] Speaker 02:
But claim one, yes, they might be talking about reducing skin irritation, but claim one, which has absolutely no limits of any kind on any percentages of any of the ingredients but for the testosterone, how in the world

[00:19:24] Speaker 02:
Does that claim, I mean, do you think this specification contains a disclaimer that indicates that only amounts that will result in a reduction in skin irritation, for example, ought to be read into this claim?

[00:19:36] Speaker 02:
Is there a disclaimer somewhere in there?

[00:19:38] Speaker 03:
No, there's not a disclaimer in there.

[00:19:40] Speaker 02:
Oh, so there's no disclaimer.

[00:19:41] Speaker 02:
There's nothing in the claim that requires a reduction in skin irritation.

[00:19:46] Speaker 02:
It's not even mentioned.

[00:19:47] Speaker 02:
And the claim contains no percentages of any kind.

[00:19:51] Speaker 03:
That's correct, Your Honor, but as I said,

[00:19:53] Speaker 02:
How is that claim not rendered obvious?

[00:19:56] Speaker 03:
Because there's nowhere when you're looking at penetration for a transdermal product, you must consider irritation.

[00:20:04] Speaker 03:
And all of the art that they are showing you tells you when you're putting these types of penetration enhancers together that our inventors chose, they would cause severe irritation.

[00:20:17] Speaker 02:
No, actually that's not correct at all, in fact.

[00:20:20] Speaker 02:
When you look at

[00:20:21] Speaker 02:
I believe it's called Foc here.

[00:20:23] Speaker 02:
I may be getting the name right.

[00:20:24] Speaker 02:
Francor.

[00:20:25] Speaker 02:
It teaches all three penetration enhancers and expressly says you should, and I'll quote, reduce the oleic acid concentration to 0.1 to 1% weight by volume for reasons of efficiency and lack of irritation.

[00:20:40] Speaker 02:
So we have one reference that doesn't disclose testosterone, mind you, but it expressly teaches

[00:20:46] Speaker 02:
a reduction in oleic acid in order to eliminate skin irritation.

[00:20:51] Speaker 02:
And it's not, in fact, the only reference that teaches that.

[00:20:54] Speaker 02:
There are other references that teach the same thing.

[00:20:56] Speaker 02:
So I'm confused.

[00:20:58] Speaker 02:
How in the world do you conclude claim one is not obvious?

[00:21:02] Speaker 03:
We don't disagree with the fact that lowering your concentration of oleic acid will benefit in some level of skin irritation.

[00:21:10] Speaker 03:
But this is a balancing situation.

[00:21:12] Speaker 03:
That's not the only

[00:21:14] Speaker 02:
Not your claim.

[00:21:14] Speaker 02:
Your claim is no balancing.

[00:21:15] Speaker 02:
Your claim has no limits to any ingredients at all.

[00:21:19] Speaker 02:
So how is it balancing anything?

[00:21:21] Speaker 03:
But the claim has three different.

[00:21:22] Speaker 02:
Unbounded.

[00:21:23] Speaker 02:
Completely unbounded.

[00:21:25] Speaker 03:
The claim has three different components to that.

[00:21:28] Speaker 03:
It has a mixed alcohol.

[00:21:30] Speaker 02:
And all three of those are disclosed in Frankor's 548 patent to be utilized together as a penetration enhancer.

[00:21:35] Speaker 02:
All three of them.

[00:21:36] Speaker 02:
None of them are missing.

[00:21:37] Speaker 03:
Well, but Frankor is not testosterone at all, and Frankor

[00:21:43] Speaker 03:
The court specifically made factual findings that you couldn't just take a penetration enhancer from here and flip a new active in there.

[00:21:53] Speaker 03:
The prior art taught you, you could not do that.

[00:21:55] Speaker 06:
What's the most specific piece of prior art that says the same penetration enhancer might produce quite different results depending on the active ingredient?

[00:22:05] Speaker 03:
2e2 tells you what happened in 2e2 is they took

[00:22:11] Speaker 03:
the three components and they tested it with two different actives and they got markedly different results.

[00:22:18] Speaker 03:
Markedly different results as far as the ability to penetrate.

[00:22:21] Speaker 03:
And so 2e2 said, and I will try to quote it for you, they tested two different actives and in that transdermal formula the 2e2 people said that because there were such divergent results when you change the active that

[00:22:39] Speaker 03:
When you're considering transdermal formulations, you must consider a three-part situation.

[00:22:46] Speaker 03:
What active are you using?

[00:22:48] Speaker 03:
What penetration enhancers are you using?

[00:22:51] Speaker 03:
And what part of the skin you are going to be using?

[00:22:53] Speaker 03:
2E2 is clear on that, that you can't do that.

[00:22:57] Speaker 03:
In addition to that, the Cooper reference, the 934 that you have talked about as well, that reference told you, don't, first of all, that was a two,

[00:23:08] Speaker 03:
combination, not a three.

[00:23:10] Speaker 03:
And it said don't use oleic acid.

[00:23:13] Speaker 03:
It said use azone.

[00:23:15] Speaker 03:
It also said once you're moving to systemic transdermal formulations, they are complicated and unpredictable.

[00:23:25] Speaker 02:
And with Cooper... And the district court clearly agreed with you and made a fact finding to that extent.

[00:23:34] Speaker 02:
However,

[00:23:39] Speaker 02:
Patel clearly discloses using testosterone and in one example using two of the three penetration enhancers, in another example using the one that wasn't used before, alcohol, and again the oleic acid.

[00:23:55] Speaker 02:
And then in the claims, claim 39, it actually discloses using all three together in combination against the active ingredient.

[00:24:04] Speaker 02:
And it discloses all of this in exasperative detail

[00:24:08] Speaker 02:
with testosterone in the relevant percentages.

[00:24:12] Speaker 02:
And it says it works as a penetration enhancer effectively with testosterone.

[00:24:19] Speaker 02:
So I don't understand.

[00:24:22] Speaker 02:
What am I missing?

[00:24:23] Speaker 03:
Well, Patel.

[00:24:25] Speaker 02:
How is there unpredictability about whether these three ingredients will work as a penetration enhancer with testosterone?

[00:24:32] Speaker 03:
Because again, as the PTO found and as the court found,

[00:24:37] Speaker 03:
This is a two-part determination.

[00:24:39] Speaker 03:
When you're looking at penetration enhancers, you must consider skin irritation.

[00:24:43] Speaker 03:
And what Patel 970 tells you is, first of all, they had either propylene glycol and ethanol or propylene glycol and oleic acid.

[00:24:52] Speaker 03:
And they say when you combine propylene glycol and oleic acid in the percentages that are here, 5%, you get severe irritation.

[00:25:04] Speaker 06:
So nobody would be looking to that because you're trying to solve a problem of... Why, I mean, did you disagree with the apparent reading of claim 39 that they actually claimed the three-part combination?

[00:25:22] Speaker 02:
Well, this is the first I've heard about it because they didn't argue it below, but... But the reference was given to the court as part of the prior art he was considering.

[00:25:31] Speaker 03:
Absolutely.

[00:25:32] Speaker 03:
My first look here today would say that these are not used as penetration enhancers.

[00:25:39] Speaker 03:
It says they're inner dilutants.

[00:25:42] Speaker 06:
That's the claim one, I think, defines that as part of the penetration enhancer, if I remember right.

[00:25:53] Speaker 06:
Yes, it does.

[00:25:54] Speaker 03:
B3.

[00:25:56] Speaker 03:
Well, the other thing is there's about

[00:25:59] Speaker 03:
eight or nine or ten of them here, and what would lead somebody to say, we'll only use these three and just these three.

[00:26:08] Speaker 03:
So this Claim 39 is no different than Patel 190, which although they had testosterone, it has five different penetration enhancers in there.

[00:26:20] Speaker 03:
What's the motivation to go to just these three, when especially the earlier Patel tells you when you go to these two,

[00:26:28] Speaker 03:
you're going to get severe irritation in the amounts that the patent describes.

[00:26:34] Speaker 06:
I may be missing something really obvious, I guess, to use the word.

[00:26:39] Speaker 06:
But if Patel 190 is understood to describe, among many other things, the combination of testosterone and this penetration enhancer within the ranges covered by the 835 and 913,

[00:26:58] Speaker 06:
What's missing from an obviousness case?

[00:27:01] Speaker 03:
Well, Patel 190 doesn't disclose these three by themselves.

[00:27:05] Speaker 03:
It discloses five of them.

[00:27:07] Speaker 03:
And it discloses Patel 190... You say five of them?

[00:27:10] Speaker 06:
I don't know what that is.

[00:27:11] Speaker 06:
Five different penetration enhancers of which the three in this... Right, but is one of the things that Patel 190 discloses the three-part combination that make up the claimed penetration enhancer in the claims that issue before us?

[00:27:28] Speaker 03:
It doesn't disclose three and only three.

[00:27:30] Speaker 03:
It discloses five together.

[00:27:32] Speaker 03:
It doesn't disclose... Never the three alone?

[00:27:35] Speaker 03:
Never the three alone.

[00:27:36] Speaker 03:
Ah, okay.

[00:27:37] Speaker 03:
It discloses five and there's no reason you would go to the three.

[00:27:41] Speaker 03:
Additionally, as you probably understand, the Patel 190 is Theratech.

[00:27:47] Speaker 03:
That is the Andraderm patch.

[00:27:50] Speaker 03:
That is the prior art that our inventors were trying to get around.

[00:27:54] Speaker 03:
So they knew and everybody knows and

[00:27:58] Speaker 03:
the defendants will not dispute, that that patch caused severe irritation.

[00:28:06] Speaker 03:
Unbelievable.

[00:28:07] Speaker 03:
There are pictures with welts from trial and all of this.

[00:28:10] Speaker 03:
So that is why would somebody be looking there when it doesn't have the three, it has the five.

[00:28:16] Speaker 03:
And that's the very art that's causing the severe irritation that you're trying to get away from.

[00:28:22] Speaker 02:
But first off, to be clear,

[00:28:26] Speaker 02:
Patel doesn't say anything about severe irritation.

[00:28:28] Speaker 02:
Patel says, does not possess the skin irritation properties.

[00:28:33] Speaker 02:
That's all it says.

[00:28:35] Speaker 02:
I don't see the words.

[00:28:35] Speaker 03:
If I can look at A621?

[00:28:38] Speaker 02:
That's where I am, yes.

[00:28:40] Speaker 02:
It says it does not possess.

[00:28:41] Speaker 03:
Last paragraph on the bottom.

[00:28:43] Speaker 03:
However, this combination of oleic acid and propylene glycol causes severe skin irritation.

[00:28:48] Speaker 04:
Where are you?

[00:28:49] Speaker 03:
Line 63 on column 11.

[00:28:54] Speaker 03:
This combination of oleic acid and propylene glycol causes severe skin irritation.

[00:28:59] Speaker 03:
Not only did the court think this taught away, but the patent office thought it taught away, too.

[00:29:03] Speaker 03:
All this art that we're talking about is in front of the court.

[00:29:05] Speaker 02:
So this combination causes severe skin irritation.

[00:29:09] Speaker 02:
But then you have Auguste, Francour, and other references which disclosed the trifecta to be used for penetration enhancement purposes expressly indicate

[00:29:24] Speaker 02:
that you can eliminate or reduce the skin irritation problem by simply reducing the amount of oleic acid to be utilized.

[00:29:33] Speaker 02:
Why doesn't that solve the problem?

[00:29:35] Speaker 02:
So Patel discloses everything.

[00:29:37] Speaker 02:
In fact, claim 39 claims all three in use with testosterone.

[00:29:42] Speaker 02:
And Patel gives two examples.

[00:29:43] Speaker 02:
And the only drawback it tells you is skin irritation.

[00:29:47] Speaker 02:
Then you have at least two references which clearly on their face expressly address the skin irritation problem.

[00:29:53] Speaker 02:
Both references are the trifecta of ingredients for a penetration enhancer.

[00:29:58] Speaker 02:
And both references say you can reduce the skin irritation by reducing the concentration of the oleic acid.

[00:30:05] Speaker 02:
Why doesn't that get you there?

[00:30:06] Speaker 02:
Why isn't that the whole ball of wax?

[00:30:08] Speaker 03:
Well, first, claim 39 has a lot more than three, as I discussed earlier.

[00:30:12] Speaker 03:
And let me talk about Onxt.

[00:30:14] Speaker 03:
Onxt references, when they tested propylene glycol and oleic acid against all of the other penetration enhancers,

[00:30:23] Speaker 03:
They found that that combination was the worst at penetration enhancing and the second worst at irritation.

[00:30:34] Speaker 03:
It was triple the next one.

[00:30:37] Speaker 03:
So angst is not telling you to use oleic acid and propylene glycol.

[00:30:41] Speaker 03:
It's telling you to use anything else.

[00:30:43] Speaker 02:
Hold on.

[00:30:44] Speaker 02:
It says it has minor or no, and these are quotes from it, irritation at concentrations below 5%.

[00:30:49] Speaker 02:
And I didn't remember that example, which is at A, 1339, suggesting it didn't function as a penetration enhancer.

[00:30:58] Speaker 03:
If I could just have a second.

[00:30:59] Speaker 03:
It's on 1339.

[00:31:02] Speaker 02:
That's the part I'm reading from.

[00:31:03] Speaker 03:
There's two tables in there.

[00:31:05] Speaker 03:
I don't have the exact page in front of me, but there's two tables.

[00:31:08] Speaker 03:
And the tables show you the penetration enhancing.

[00:31:11] Speaker 03:
I believe it is at 1354.

[00:31:14] Speaker 02:
I'm reading from 1339.

[00:31:17] Speaker 02:
Why don't you turn to that?

[00:31:19] Speaker 02:
Because there are two different angst references.

[00:31:21] Speaker 02:
One of them is not so good for them, but one of them is good for them.

[00:31:25] Speaker 03:
Well, the one that you're reading from says, the major task in successfully using fatty acids for delivering drugs through the skin will be in avoiding skin irritation.

[00:31:34] Speaker 03:
That's at 1340 for that one.

[00:31:45] Speaker 03:
Right.

[00:31:47] Speaker 03:
So if we're looking at 1339, it tells you about 10% here.

[00:31:55] Speaker 03:
It does tell you that the lower you go, the better it will be.

[00:31:59] Speaker 03:
But the problem is that once you go lower with oleic acid, you have to balance, especially according to 2E2 and the other references.

[00:32:09] Speaker 03:
This is a three-part analysis.

[00:32:11] Speaker 03:
You have to look at where you're putting it on the skin.

[00:32:13] Speaker 03:
You have to look at the

[00:32:15] Speaker 02:
So the claims don't limit where it's being placed on the skin?

[00:32:18] Speaker 03:
No, the claims do not.

[00:32:19] Speaker 02:
So then why do I need to look at where it's being put on the skin to decide whether these claims are anticipated or rendered obvious?

[00:32:25] Speaker 03:
Again, because this is a transdermal formulation, according to the specification, takes all of these things into account when you're deciding how you're going to come up with your possible penetration enhancers.

[00:32:39] Speaker 06:
Hey, can I ask you just a minute, I guess a couple of very focused things.

[00:32:43] Speaker 06:
So we were looking at 1340, I think you actually read something from that.

[00:32:47] Speaker 06:
Yes.

[00:32:47] Speaker 06:
There's a sentence almost exactly in the middle in the paragraph just before summary.

[00:32:55] Speaker 06:
It was claimed that an oleic acid, PG is that?

[00:33:01] Speaker 03:
Problinc glycol.

[00:33:01] Speaker 06:
Problinc glycol, glycerin.

[00:33:04] Speaker 06:
I see, that's missing the alcohol, I see.

[00:33:07] Speaker 06:
Right.

[00:33:07] Speaker 06:
Okay.

[00:33:09] Speaker 06:
turned back to Patel 970, 621, you noted the sentence, this combination of oleic acid and propylene glycol causes severe skin irritations.

[00:33:20] Speaker 03:
Yes.

[00:33:21] Speaker 06:
That's a sentence that again is about test 2D, which doesn't include the alcohol.

[00:33:27] Speaker 03:
It doesn't include the alcohol, and it also would apply equally to example three because it's the same percentages of oleic acid as well.

[00:33:36] Speaker 06:
Well, how do we know that?

[00:33:37] Speaker 06:
I mean, example 3A is the one that has the three-part penetration enhancer, right, oleic acid?

[00:33:48] Speaker 06:
I think it was example C. Is glycerol dilate the same?

[00:33:55] Speaker 06:
Is that covered by the glycol in the claims as defined by the spec or not?

[00:34:03] Speaker 06:
No.

[00:34:04] Speaker 06:
OK.

[00:34:05] Speaker 06:
So which is the example in example three that has the three-part combination?

[00:34:11] Speaker 03:
Three, you see the 95-propylene glycol.

[00:34:15] Speaker 03:
I think it's C and the 5% oleic acid.

[00:34:22] Speaker 06:
But no alcohol.

[00:34:23] Speaker 03:
But no alcohol.

[00:34:25] Speaker 03:
Well, there's ethanol, but no mixture.

[00:34:27] Speaker 03:
No mixture.

[00:34:28] Speaker 03:
Okay.

[00:34:29] Speaker 03:
So the mixture isn't disclosed.

[00:34:30] Speaker 02:
The alcohol is disclosed in the following example, right?

[00:34:33] Speaker 02:
Example 4, where you have oleic acid and the alcohol.

[00:34:40] Speaker 02:
Is that right?

[00:34:40] Speaker 02:
In example 4F, alcohol plus oleic acid and testosterone.

[00:34:46] Speaker 03:
Right, but does that one have propylene glycol in it as well?

[00:34:52] Speaker 02:
No, it doesn't.

[00:34:53] Speaker 03:
So it's missing some of the components.

[00:34:55] Speaker 02:
Right.

[00:34:56] Speaker 02:
So carpline, glycol, and oleic acid are in example three.

[00:34:59] Speaker 02:
Right.

[00:34:59] Speaker 02:
And oleic acid and alcohol are in example four.

[00:35:02] Speaker 02:
Right.

[00:35:03] Speaker 02:
And the claim covers all three.

[00:35:04] Speaker 04:
Correct.

[00:35:05] Speaker 02:
And your question is, you claim we have to focus on skin irritation, even though most of the claims have no boundaries whatsoever for any of the ingredients.

[00:35:14] Speaker 02:
And we know that at various concentrations, these will cause skin irritation.

[00:35:19] Speaker 02:
And your claims are unbounded.

[00:35:20] Speaker 02:
But what you never dealt with, what I'd like you to focus on, is page 1339 and the sentence in particular that I read to you before, which says oleic acid at 0.5 and 1% concentration causes no change or only minor damage to skinny pig skin, but these concentrations are still effective at enhancing transdermal absorption.

[00:35:44] Speaker 02:
So you claimed to me before that one of the flaws was they may say reducing oleic acid, but they don't talk about it still being effective as a penetration enhancer.

[00:35:52] Speaker 02:
But this actually expressly says it reduces it and is still effective as a penetration enhancer.

[00:35:59] Speaker 02:
So go ahead, consult for a second.

[00:36:09] Speaker 03:
Yes.

[00:36:10] Speaker 03:
So that discussion is with guinea pigs versus

[00:36:13] Speaker 02:
humans, and that's a distinction that's made here in terms of... I didn't see the district court make any fact findings anywhere that suggested that the results shown on guinea pigs would not predictably translate into humans.

[00:36:27] Speaker 02:
Did he make any finding along those lines?

[00:36:29] Speaker 03:
No, but he made a general finding that this art in general is totally unpredictable and changing the slightest thing will make it you don't know what's going to happen.

[00:36:39] Speaker 02:
No, he made that finding with respect to picking

[00:36:42] Speaker 02:
active ingredients and penetration enhancers and making those combinations.

[00:36:47] Speaker 02:
I never saw any suggestion or discussion anywhere in the idea that because this was shown to work on guinea pigs, there's some question about its predictable use.

[00:36:55] Speaker 03:
No, he did not make that.

[00:36:56] Speaker 03:
He made a more general one that it was unpredictable in terms of just putting the penetration enhancers together and then putting them with a certain active.

[00:37:08] Speaker 03:
He made it general.

[00:37:09] Speaker 03:
If I could address the

[00:37:12] Speaker 03:
onks that you were talking about for just one minute and I know I'm over.

[00:37:17] Speaker 03:
If we look at A1356, you'll see the chart down at the bottom and you'll see oleic acid's enhancement factor.

[00:37:26] Speaker 03:
This is the second onks.

[00:37:27] Speaker 02:
That's not the same reference that I was just reading from.

[00:37:32] Speaker 02:
I don't have any disagreement with you or the district court's finding about one of the two onks references.

[00:37:38] Speaker 02:
It's the first one that is problematic, which is why I was reading

[00:37:42] Speaker 06:
And you were looking at this 1357, is there text or is this the... This is the chart on 1356.

[00:37:48] Speaker 06:
The table or the... The table, I'm sorry.

[00:37:51] Speaker 06:
Not the diagram, because the diagram has a counterpart.

[00:37:53] Speaker 03:
Right, at the bottom, in the middle, the table, it shows you that oleic acid's enhancement factor is 14, which is the worst of all of them.

[00:38:02] Speaker 03:
And interestingly, to show you how

[00:38:05] Speaker 03:
A small difference can make a huge difference.

[00:38:07] Speaker 06:
I'm sorry.

[00:38:08] Speaker 06:
I've lost my place now.

[00:38:09] Speaker 03:
What page?

[00:38:10] Speaker 03:
1356.

[00:38:11] Speaker 06:
There's a chart down here at the bottom.

[00:38:14] Speaker 03:
Right here?

[00:38:14] Speaker 03:
Yeah.

[00:38:15] Speaker 03:
So if you look, you see the enhancement factor for oleic acid is 14.

[00:38:20] Speaker 03:
And yet you see the one below, elatic acid, which is an isomer of oleic acid, has almost doubled the enhancement factor.

[00:38:31] Speaker 03:
And then when you go to the next page, 1357,

[00:38:34] Speaker 03:
you see that oleic acid, the skin irritation index is 2.3, which is triple the isomer that's G below at 0.7.

[00:38:46] Speaker 03:
So you can see making a small change to an isomer of an oleic acid has a profound effect on what's happening.

[00:38:54] Speaker 03:
So there is no way to predict that this penetration enhancer, when you put these three together,

[00:39:01] Speaker 03:
they're going to work no matter what the percentages are.

[00:39:03] Speaker 03:
Whether you lower one, you might have to up another one, and it's just totally unpredictable.

[00:39:10] Speaker 02:
But your patent doesn't claim any of those percentages.

[00:39:12] Speaker 02:
That's the part that's still driving me crazy.

[00:39:15] Speaker 03:
Well, I didn't write it, but I apologize.

[00:39:16] Speaker 03:
But it does claim, in claim six and in claim 22, there are specific ranges.

[00:39:20] Speaker 02:
Which are not dependent on each other.

[00:39:21] Speaker 02:
So claim six gives you a range for oleic acid only and allows any range for glycol and for, what's the third one?

[00:39:30] Speaker 03:
Ethanol.

[00:39:31] Speaker 02:
Ethanol.

[00:39:31] Speaker 03:
A mixed alcohol.

[00:39:32] Speaker 02:
Right?

[00:39:33] Speaker 02:
Right.

[00:39:33] Speaker 02:
So any percentages.

[00:39:35] Speaker 02:
Correct.

[00:39:35] Speaker 02:
And they claim 22 has a percentage range for glycol, 30 to 40, I think, if I remember right.

[00:39:40] Speaker 03:
Right.

[00:39:40] Speaker 02:
And no limits on the amount of oleic acid or on the amount of alcohol.

[00:39:45] Speaker 03:
Right.

[00:39:46] Speaker 03:
But Frank, the reference you were talking about says when you use more than 10% of propylene glycol, you get severe irritation.

[00:39:52] Speaker 03:
So again, all of these references.

[00:39:55] Speaker 02:
And so that would help you on claim 22.

[00:39:58] Speaker 03:
Correct.

[00:39:58] Speaker 02:
But it would be of no value to you on any other claim in the patent, because no other claim on the patent has a limit on the amount of glycol.

[00:40:06] Speaker 03:
Correct?

[00:40:07] Speaker 03:
No other claim that we're asserting has a limit.

[00:40:08] Speaker 02:
In either patent.

[00:40:09] Speaker 03:
Right.

[00:40:10] Speaker 02:
They are being asserted.

[00:40:11] Speaker 02:
Fair characterization.

[00:40:12] Speaker 03:
That we're asserting.

[00:40:13] Speaker 03:
That's correct.

[00:40:14] Speaker 03:
But again, the problem is this is a two-part test.

[00:40:18] Speaker 03:
Most of this art that you're talking about

[00:40:20] Speaker 03:
was before the Patent Office.

[00:40:22] Speaker 03:
The Patent Office made a determination that both Patels teach away.

[00:40:27] Speaker 03:
The district court made that same finding.

[00:40:30] Speaker 03:
It wasn't clear error.

[00:40:31] Speaker 03:
The Patel 970 that you talked again, it was only two.

[00:40:34] Speaker 03:
That claim 39 listed about eight of them, or nine of them.

[00:40:39] Speaker 03:
There's no reason to take three.

[00:40:40] Speaker 02:
Eight of nine that could be used for glycol.

[00:40:42] Speaker 02:
Oleic acid was fixed in claim one, and the alcohol was fixed in claim one.

[00:40:48] Speaker 02:
And then claim 39 added a third penetration enhancing ingredient to be selected from a list of eight or so.

[00:40:56] Speaker 03:
Right.

[00:40:56] Speaker 03:
So why would you pick one versus the other when there's so much art out there that tells you that oleic acid with propylene glycol is going to cause severe irritation?

[00:41:09] Speaker 03:
So why would you pick a mixed alcohol from claim 39?

[00:41:12] Speaker 03:
There's no teaching or anything that would teach you

[00:41:17] Speaker 03:
to find a mixed alcohol.

[00:41:18] Speaker 03:
And when you're looking at the oleic acid that they're talking about, again, it's causing severe irritation at the examples that they're giving.

[00:41:27] Speaker 02:
One more thing.

[00:41:28] Speaker 02:
You say there's nothing to teach you that, but Francor actually does.

[00:41:30] Speaker 02:
Francor teaches you to use the three, as does the Onks reference that I read from.

[00:41:35] Speaker 02:
And both of those two references, both of them, do teach those three exact combinations as penetration enhancers.

[00:41:43] Speaker 02:
And both of them expressly address

[00:41:46] Speaker 02:
the skin irritability problem being solved by reducing oleic acid.

[00:41:51] Speaker 02:
And so those don't pertain to testosterone.

[00:41:54] Speaker 02:
Grant you that.

[00:41:55] Speaker 02:
But don't both of them do that?

[00:41:57] Speaker 03:
Both of them tell you, and it's well known in the art, that if you reduce the oleic acid, you would get less skin irritation.

[00:42:03] Speaker 02:
And in this exact trifecta combination, correct?

[00:42:08] Speaker 03:
No.

[00:42:08] Speaker 02:
Falkir does not disclose the trifecta combination for penetration enhancer.

[00:42:12] Speaker 03:
It does, but it says once you use propylene glycol above 10%, which you would have to do if you use 0.1% oleic acid, now you've got Francour telling you that that's irritating and don't do that.

[00:42:27] Speaker 03:
And Francour, again, was before the patent office and was also before the court.

[00:42:31] Speaker 03:
And the district court made these findings that that taught away because of the excess glycol.

[00:42:37] Speaker 03:
And again, Francour

[00:42:38] Speaker 03:
is not testosterone.

[00:42:40] Speaker 03:
The only one that's testosterone is Patel, and it teaches you severe irritation, or it teaches you, this is the patch that we want to get over, and here are five different possible ones you could use, and why would you pick these particular three?

[00:42:56] Speaker 03:
All the other art was before the Patel.

[00:42:57] Speaker 06:
Can you process one question?

[00:42:59] Speaker 06:
Sure.

[00:42:59] Speaker 06:
I'm looking at 190.

[00:43:02] Speaker 06:
You said earlier,

[00:43:06] Speaker 06:
This is page 6, 12, and 13 of the appendix, the Patel 190 patent.

[00:43:14] Speaker 06:
And you said that the 190 never teaches the 3-oleic acid, ethanol, propylene glycol, and a mixture alone.

[00:43:29] Speaker 06:
And that's because every example has the methylchlorate part of it?

[00:43:34] Speaker 03:
Yes.

[00:43:37] Speaker 02:
OK, thank you very much.

[00:43:40] Speaker 03:
Thank you very much, Your Honor.

[00:43:42] Speaker 02:
Mr. Lombardi, I'll give you two minutes of rebuttal time if there are questions that may end up going a little longer.

[00:43:50] Speaker 00:
Thank you.

[00:43:50] Speaker 06:
Have you found a reference to Claim 39?

[00:43:52] Speaker 00:
I did, Your Honor, and I agree with Your Honor's reading of Claim 39.

[00:43:56] Speaker 06:
No, no, no, I'm sorry.

[00:43:59] Speaker 06:
A reference in your briefing or submission to the distant court about it.

[00:44:03] Speaker 00:
No, Your Honor.

[00:44:04] Speaker 00:
OK.

[00:44:04] Speaker 00:
And Your Honor, to go back to Francour and the statement

[00:44:08] Speaker 00:
It teaches away in terms of the amount of propylene glycol.

[00:44:11] Speaker 00:
I don't believe that's accurate.

[00:44:13] Speaker 00:
If you look at column 19 of front core, which is at appendix 1266, it has the oleic acid is referenced in the paragraph above the table and then the remainder of the penetration enhancer is below.

[00:44:32] Speaker 00:
And you can see there are several examples where propylene glycol is used in the percentages that are claimed in Claim 21.

[00:44:40] Speaker 02:
So... Walk through that a little slower.

[00:44:42] Speaker 00:
I'm sorry, Your Honor.

[00:44:44] Speaker 00:
So we're at example 15 of Francois.

[00:44:48] Speaker 00:
And at line 38 talks about 0.25% of oleic acid.

[00:44:57] Speaker 00:
That's within the claims.

[00:44:59] Speaker 00:
And then if you look at the table,

[00:45:01] Speaker 00:
It talks about ethanol, that's the alcohol, and PG, which is the propylene glycol.

[00:45:06] Speaker 00:
And so with the slashes there, the ethanol is first and the propylene glycol is second.

[00:45:12] Speaker 00:
And so specifically, if you look, for instance, at the second, 33 slash 33 indicates that that has 33% of the propylene glycol.

[00:45:21] Speaker 02:
The one below it has... That would fall right within claim 22.

[00:45:24] Speaker 00:
That's correct, Your Honor.

[00:45:26] Speaker 00:
And the reference to propylene glycol is allegedly being... These things have a third slash.

[00:45:37] Speaker 00:
What's the third slash?

[00:45:40] Speaker 00:
The third slash is the Tris buffer solution.

[00:45:44] Speaker 02:
Does that matter?

[00:45:46] Speaker 00:
No.

[00:45:47] Speaker 05:
This is my problem.

[00:45:54] Speaker 05:
How do I know that doesn't matter?

[00:45:56] Speaker 05:
In this case, we talked about minute passages in about a dozen different references to show why or why not this is obvious.

[00:46:04] Speaker 05:
The district court made a lot of factual findings, and we're disputing whether they're right or not.

[00:46:09] Speaker 05:
And you just said something that I haven't heard about doesn't matter.

[00:46:13] Speaker 05:
How can I reverse the district court based upon something that wasn't ever told to me before?

[00:46:18] Speaker 00:
Well, I can say this, Your Honor.

[00:46:20] Speaker 00:
It was never an issue in the district court.

[00:46:21] Speaker 00:
It wasn't raised by the other side as an issue in the district court.

[00:46:24] Speaker 00:
And this was a reference that was fiscal.

[00:46:26] Speaker 05:
But you're the one that has to show me error, not them.

[00:46:29] Speaker 00:
Correct, Your Honor.

[00:46:31] Speaker 00:
And what I'm saying is that this was presented to the district court.

[00:46:34] Speaker 00:
If it did matter, we could anticipate that it would have been raised by the other side.

[00:46:38] Speaker 00:
And it was not

[00:46:39] Speaker 02:
One of the examples in the third example is zero, right?

[00:46:42] Speaker 02:
Like in the third example that you just pointed me to, it's actually zero in the third pile.

[00:46:45] Speaker 00:
And that's correct as well.

[00:46:46] Speaker 02:
So that one's not.

[00:46:47] Speaker 02:
That one example wouldn't even matter whether if they argued the tris made a difference, whatever the heck that is.

[00:46:54] Speaker 02:
The third example shows it at zero.

[00:46:56] Speaker 00:
That's correct, Your Honor.

[00:46:58] Speaker 00:
And I know I have very little time here.

[00:47:01] Speaker 00:
So I will just comment that Your Honor is exactly right on the skin irritation point not being claimed, which I think is a key factor in this entire case.

[00:47:10] Speaker 00:
The district court, I think, based a lot of its ruling on the fact that it felt that any reference to irritation in a reference and a prior art reference taught a way

[00:47:21] Speaker 00:
But the fact is that there's no claim to reduce skin irritation.

[00:47:25] Speaker 00:
There's no quantification of reduced skin irritation.

[00:47:27] Speaker 00:
And it was known in the art that skin irritation was caused by penetration enhancers and that you reduce that skin irritation by reducing the amount of the penetration enhancers.

[00:47:39] Speaker 00:
So the skin irritation, I think, was an example.

[00:47:42] Speaker 00:
The emphasis on the skin irritation was an example of the court misconceiving the teaching away inquiry in this case because it was not the invention.

[00:47:50] Speaker 00:
And the arts specifically taught skin irritation and how to deal with skin irritation.

[00:47:54] Speaker 02:
I know that Judge Hughes kind of said this a second ago.

[00:47:59] Speaker 02:
And I guess I want to echo it because I think that you have some good points buried within a morass of issues that you appealed.

[00:48:10] Speaker 02:
I think that it's possible the district court clearly aired a number of different fact findings.

[00:48:15] Speaker 02:
But some of those are almost irrelevant to whether you can prevail or not.

[00:48:20] Speaker 02:
And the difficulty is you didn't narrow down or focus your issues on appeal for us to allow you to thoroughly and thoughtfully address particular references or particular combinations.

[00:48:33] Speaker 02:
You literally threw 12 references at us.

[00:48:35] Speaker 02:
And I don't see in your brief much of an attempt to say, this plus this renders this claim invalid.

[00:48:43] Speaker 02:
This plus this renders this claim invalid.

[00:48:45] Speaker 02:
Like I said to my law clerks, OK, listen, before you even get started on this,

[00:48:49] Speaker 02:
Make a chart, claims, their elements, references across the top, boxes with little x's in them, where you see them.

[00:48:56] Speaker 02:
I mean, I don't know.

[00:48:59] Speaker 02:
The shotgun approach you may have felt like was good before the district court, but it didn't serve you as well before us, to be honest with you.

[00:49:06] Speaker 02:
And this is a complicated case, and I think

[00:49:10] Speaker 02:
You've made some good arguments, but unfortunately, they aren't as flushed out as I wish they were, given especially the complexity of the technology.

[00:49:19] Speaker 02:
We've got a room full of people.

[00:49:20] Speaker 02:
I feel like you're all here for this case.

[00:49:22] Speaker 02:
So I'm not just speaking to you.

[00:49:23] Speaker 02:
I'm speaking to the entire room full of people, because you want us to understand and master this kind of stuff, 12 references without identifying particular combinations and linking them up for what they teach to particular claim elements and everything else.

[00:49:40] Speaker 02:
You're kind of putting a lot of the burden on us, and it doesn't serve as well in terms of your ability to persuade, especially when you're appellant in particular, obviously.

[00:49:52] Speaker 02:
So in the future, it would really probably help us if you tried to synthesize your case into maybe fewer and more detailed arguments instead of quite so many.

[00:50:03] Speaker 02:
I'm hoping that there's in-house counsel here as well, because I know that you don't make all the decisions on exactly what issues are appealed and everything.

[00:50:10] Speaker 02:
But hopefully you can take this back to them the next time, if they fight you on how many issues to appeal, you can say, look at this transcript.

[00:50:19] Speaker 02:
So anyway, that's it.

[00:50:21] Speaker 02:
But I have to conclude the argument.

[00:50:23] Speaker 02:
And I want to say, you both did a fabulous job.

[00:50:25] Speaker 02:
I appreciate all the effort, the hard work, and the thorough understanding of an enormous amount of material.

[00:50:31] Speaker 02:
It was helpful to me.

[00:50:32] Speaker 02:
So thank you both.

[00:50:34] Speaker 00:
And I appreciate your comments Your Honor.

[00:50:35] Speaker 00:
Thank you.