[00:00:02] Speaker 02:
First case for argument this morning is 18-218-9 in Ray Thermal Life International.

[00:00:09] Speaker 02:
Mr. Guyarza, good morning.

[00:00:21] Speaker 00:
Thank you, may it please the court.

[00:00:22] Speaker 00:
Robert Guyarza from Latham-Walkins for Thermal Life International.

[00:00:27] Speaker 00:
Claim 6 was already allowed by the PTO, and there's no sound basis in law or fact for the PTO to withdraw that allowance, and there was no sound basis for the board to affirm that rejection.

[00:00:36] Speaker 00:
The board's opinion is affected by legal error and confirmation bias in several ways, but the main way is that it used thermalized inventive disclosure against it.

[00:00:45] Speaker 00:
The board used it when interpreting the prior art disclosure, for example on Apex 22, where they said that we find the amount of guidance provided in the prior art is substantial, particularly as the process described

[00:00:55] Speaker 00:
appear substantially identical to the method taught in the 07-4 pattern.

[00:00:59] Speaker 00:
They did so again on Apex 18 when dismissing the shortcomings of the prior art and expert testimony.

[00:01:04] Speaker 00:
And they said the same second method.

[00:01:08] Speaker 03:
As I understand it, there are two issues.

[00:01:09] Speaker 03:
What did the prior art disclose, and was the prior art enabling?

[00:01:13] Speaker 03:
Which of those two issues do the references by the board to this patent bear on?

[00:01:19] Speaker 00:
On both of them, Your Honor.

[00:01:21] Speaker 00:
So when they were interpreting the prior art disclosures, they said the guidance and the prior art is substantial.

[00:01:25] Speaker 00:
And particularly, for example, when they were saying for enablement, the amount of experimentation

[00:01:31] Speaker 00:
necessary to the mixing method was cited as being substantially identical.

[00:01:35] Speaker 03:
So what the board- Right, but just on enablement, I mean, I had taken it that it is fairly common and legitimate when a patent owner responds to an anticipation rejection by saying that reference is not enabling for the board to say, look,

[00:02:00] Speaker 03:
the teaching of how to make in the prior art reference is really about the same level of detail as what you find in the patent owner's patent.

[00:02:12] Speaker 03:
And that actually counts in favor of the rejection.

[00:02:16] Speaker 03:
So that's not an illegitimate reference.

[00:02:19] Speaker 00:
Not the level of detail, Your Honor.

[00:02:21] Speaker 00:
What they did is they looked to it to confirm what the prior art was saying.

[00:02:24] Speaker 00:
And that's error under this court's case law in Rasmussen and Morse to actually fill in the gaps in the prior art.

[00:02:30] Speaker 00:
Because what we know here is that the specimen, sorry, just to back up one second, is that the board didn't just ask about whether it was the same.

[00:02:38] Speaker 00:
The board erected a higher legal test.

[00:02:40] Speaker 00:
for presumption of enablement because of the supposed substantial identical nature of the thermal life process.

[00:02:49] Speaker 00:
Specifically in Apex 30, they didn't just say that it's identical.

[00:02:52] Speaker 00:
What they said is it has not been shown to be, the thermal life process has not been shown to be quote, substantially different.

[00:02:59] Speaker 00:
And because of that, they have not shown, conclusively shown that the stains mixing process does not produce creatine nitrate.

[00:03:05] Speaker 02:
Do you agree that the burden of proof

[00:03:08] Speaker 02:
would rest with you and your client.

[00:03:13] Speaker 02:
But your argument is that the standard that was applied, the burden of proof, the amount of burden was incorrect.

[00:03:21] Speaker 02:
Do you agree, though, that you had the burden of proof on enablement, at least after the PTO submitted or presented a prima facie case?

[00:03:31] Speaker 00:
If they did present a prima facie case, then yes, but they didn't.

[00:03:35] Speaker 00:
Because DeSanes and Gamelan disclosed a different compound on their face.

[00:03:39] Speaker 00:
It can't be the test that you have a burden to disprove making a different compound.

[00:03:44] Speaker 00:
That flips an inquiry on its head.

[00:03:46] Speaker 02:
But assuming that there was a prima facie case, you would agree that your client had the burden of proof to show enablement.

[00:03:51] Speaker 02:
And then your challenge is more to the language that the board used,

[00:03:56] Speaker 02:
the amount of proof that they required, where they referred to conclusively and other language like that.

[00:04:01] Speaker 00:
Yes, if there was a prima facie case, we would agree with that.

[00:04:04] Speaker 00:
And the board went farther than that, though.

[00:04:06] Speaker 00:
The board specifically said they were looking for clear error.

[00:04:10] Speaker 03:
And I believe on Apex 30, it's... Just to be clear, the clear error statement is in the portion of the board's opinion discussing what the art teaches, not the enablement portion, right?

[00:04:22] Speaker 03:
That's Apex 16 to 17.

[00:04:24] Speaker 03:
I thought we were just talking about the enablement.

[00:04:25] Speaker 00:
They go hand in hand though because you can't enable something if it doesn't disclose the compound.

[00:04:30] Speaker 00:
That's just basic common sense.

[00:04:32] Speaker 00:
And so what the board said is that without sufficient evidence to support a finding of clear error, this is Apex 16 to 17, we're unwilling to find the express teaching of creatine nitrate to be ambiguous.

[00:04:44] Speaker 00:
And they went a step further.

[00:04:45] Speaker 00:
They also did it for enablement on Apex 30.

[00:04:48] Speaker 00:
What they said was it's not just substantially identical.

[00:04:51] Speaker 00:
They said thermolife failed to show that it was, quote, substantially different.

[00:04:55] Speaker 00:
And indeed it is.

[00:04:56] Speaker 00:
The thermolife process is irrefutably different than the mixing process in the same.

[00:05:03] Speaker 00:
Because of the order in which water is added?

[00:05:06] Speaker 00:
Not just the order, Your Honor.

[00:05:07] Speaker 00:
It has a separate step.

[00:05:08] Speaker 00:
And that separate step is not the same as the same.

[00:05:11] Speaker 03:
What is the separate step?

[00:05:13] Speaker 00:
The separate step of water.

[00:05:14] Speaker 00:
It has a separate step of adding water to the mixture

[00:05:17] Speaker 00:
of creatine or amino acid and the acid.

[00:05:20] Speaker 02:
Can you provide a finer point on that?

[00:05:22] Speaker 02:
Exactly what is the difference?

[00:05:24] Speaker 02:
It has a separate step of adding water.

[00:05:25] Speaker 02:
When is that?

[00:05:26] Speaker 02:
How does it compare?

[00:05:28] Speaker 02:
They sound very similar.

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

[00:05:30] Speaker 00:
On Apex 38, column 9, 19 to 21, it's a cost-effective method synthesized creatine nitrate by combining nitric acid and creatine.

[00:05:38] Speaker 00:
That's the first step.

[00:05:40] Speaker 00:
Then mixing with water.

[00:05:41] Speaker 00:
Sorry, the then is not there, but then mixing with water and leaving to crystallize.

[00:05:46] Speaker 00:
There's two differences between that and the prior art.

[00:05:49] Speaker 00:
First is the individual step of mixing with water.

[00:05:52] Speaker 00:
That is not simply dilution, as the board said, as one of ordinary skill in the art would know that if creatine dehydrates, it turns to creatinine, which is important.

[00:06:02] Speaker 00:
And the second difference is to crystallize.

[00:06:05] Speaker 00:
It's not evaporate.

[00:06:06] Speaker 00:
It's crystallize.

[00:06:08] Speaker 00:
And again, why that matters, as one of ordinary skill in the art would know, is if you evaporate, you're going to get

[00:06:15] Speaker 00:
creatinine, which is useless.

[00:06:17] Speaker 00:
You need creatine.

[00:06:19] Speaker 00:
And the crystallization and the evaporation, that's at 3695 of the record.

[00:06:25] Speaker 00:
And it's also in Gamelan at 4158 of the record.

[00:06:27] Speaker 00:
So it's well known.

[00:06:29] Speaker 00:
So the process is different.

[00:06:30] Speaker 00:
And the PTO relied on its assumption that it was the same to ignore the errors in the prior art.

[00:06:37] Speaker 00:
And it also did that for enablement, too.

[00:06:39] Speaker 00:
And there's really four facts, if you look at them, that the board overlooked.

[00:06:45] Speaker 00:
Number one is that gamelan teaches no matter what strength of acid you mix creatine with, it's not going to produce creatine nitrate.

[00:06:54] Speaker 00:
It says on 3158 that if you mix creatine with a strong acid, it's going to create creatinine.

[00:07:04] Speaker 00:
If you mix it with a dilute acid, nothing happens.

[00:07:08] Speaker 00:
So that shows specifically that the mixing method doesn't work.

[00:07:11] Speaker 00:
It wasn't expected to work.

[00:07:13] Speaker 00:
And then in disanes, there's three more.

[00:07:14] Speaker 00:
I promise you four.

[00:07:15] Speaker 00:
Three are for disanes itself.

[00:07:18] Speaker 00:
On 3627 of the record, Dr. Chamberlain expressly showed that the bubbling method, the first method in disanes, cannot work as a matter of accepted science.

[00:07:28] Speaker 00:
That's the equations that he showed.

[00:07:30] Speaker 00:
Any product of that is not creatine nitrate.

[00:07:33] Speaker 00:
And that's irrefutable.

[00:07:33] Speaker 00:
And the board has never addressed it other than the PTO and the appeal.

[00:07:36] Speaker 03:
And the relevance of that to the mixing method?

[00:07:39] Speaker 00:
So it's to disane itself.

[00:07:42] Speaker 00:
It shows that it's not.

[00:07:42] Speaker 00:
And the relevance is by point three, which is disanes also says that what's produced by the bubbling method and what's produced by the mixing method is, quote, the same compound.

[00:07:52] Speaker 00:
So if it's the same compound and you already know that it's not creating nitrate, you know it's not going to be creating nitrate for the mixing method.

[00:07:59] Speaker 00:
But that alone is not enough.

[00:08:01] Speaker 00:
For the mixing method itself, I'm sorry.

[00:08:04] Speaker 00:
I believe I gave you the wrong site.

[00:08:05] Speaker 00:
The equations is 42.12 for Dr. Chamberlain.

[00:08:08] Speaker 00:
But on 3627, Dr. Chamberlain looked at the mixing method, and he said, as an irrefutable matter of just simple math and chemistry, the mixing method did not create creatine nitrate.

[00:08:20] Speaker 00:
If you assume in favor of the sayings that he was using the exact amounts of creatine, 1.057 grams, and that it was equimolar amounts, and somehow he did that back then, the result would be 1.556 grams of creatine nitrate.

[00:08:35] Speaker 02:
Now, talking about creatine nitrate, you said that the formula in Desans is different.

[00:08:40] Speaker 02:
I agree that the formula in Gamlin seems different.

[00:08:44] Speaker 02:
But Desans is just two moles.

[00:08:47] Speaker 02:
And the board explained that it was, I think they used the word converted to the same formula of one mole of creatine nitrate.

[00:08:56] Speaker 02:
They had the right formula just doubled for creatine.

[00:09:00] Speaker 02:
And the doubled formula for creatine nitrate, two moles versus one mole.

[00:09:05] Speaker 02:
Why should I not credit that fact finding by the board that it converts, it's the same formula, one is just one mole versus two moles?

[00:09:16] Speaker 00:
For three reasons.

[00:09:17] Speaker 00:
First, that's just hindsight based on what we now know about creatine.

[00:09:20] Speaker 00:
Second, it's not science.

[00:09:21] Speaker 00:
You can't simply divide by two.

[00:09:23] Speaker 00:
And three, DeSane's didn't just- How do I know it's not science?

[00:09:27] Speaker 00:
My third point is that DeSane specifically says that it determined the formulas

[00:09:31] Speaker 00:
based on the weights, the percentage of 32.8% that Dr. Chamberlain was talking about.

[00:09:37] Speaker 00:
And he specifically explained how those weights don't add up.

[00:09:41] Speaker 00:
That's at 42.13 of the record.

[00:09:43] Speaker 00:
He said, even if you assume that, even if you take that at face value, it still makes no sense.

[00:09:48] Speaker 00:
It can't be just dividing by 2, because he got the formula by percentages.

[00:09:52] Speaker 02:
So is it your position that there's your expert's testimony on this point versus the board's

[00:09:59] Speaker 02:
Assumption is there any evidence at all to support the board's fact-finding?

[00:10:04] Speaker 02:
No, there's nothing but to say so that it's the skill of one of ordinary skill in the art just to mix it That's the same argument that they made about the formula you said just to mix it, but I meant about that the formula it wanted what that the formula for creating nitrate and descends converts

[00:10:22] Speaker 02:
to one mole of the formula in the patented invention.

[00:10:25] Speaker 00:
I apologize, Your Honor.

[00:10:25] Speaker 00:
There is no evidence for that either.

[00:10:27] Speaker 00:
The only evidence in the record is Dr. Chamberlain saying that that's not the right conversion because of the percentages and how that formula was calculated.

[00:10:34] Speaker 00:
You can't just divide by two.

[00:10:36] Speaker 00:
It's not that simple.

[00:10:37] Speaker 03:
How is a procedural matter in a ex-party proceeding in the board?

[00:10:43] Speaker 03:
Does evidence get developed contrary to the applicant, or in this case, patent owner's evidence?

[00:10:51] Speaker 00:
I believe the examiner would search for it, Your Honor.

[00:10:54] Speaker 00:
And they would bring up the prior art references that they would have.

[00:10:57] Speaker 03:
But the examiner, at least as an ordinary matter, doesn't get to hire an expert.

[00:11:04] Speaker 00:
Not that I'm aware of, no.

[00:11:06] Speaker 00:
But here, that's exactly what the examiner did, which is what is so remarkable.

[00:11:10] Speaker 00:
The examiner and the board and the PTO didn't just have to say so.

[00:11:14] Speaker 00:
They had all these modern references before it to support the idea that it's simple mixing.

[00:11:19] Speaker 00:
They had all of them.

[00:11:20] Speaker 00:
Indeed, when claim six was denied or sorry, when the rejected, when the allowance was pulled back, they added Terzian to make that exact point that according to modern science, you can just mix it.

[00:11:32] Speaker 00:
That's exactly what they said.

[00:11:33] Speaker 00:
And yet, Thermolife has traversed every single one of those modern references, including by the co-author of Terzian, Dr. Petrazian, who said that's unreasonable to just believe that.

[00:11:43] Speaker 00:
There's no expectation of success in that.

[00:11:45] Speaker 00:
And you can't just get that from mixing.

[00:11:47] Speaker 00:
And all of that evidence is unrebutted.

[00:11:50] Speaker 00:
But you still have the four points.

[00:11:52] Speaker 00:
Gamelan teaches away.

[00:11:53] Speaker 00:
It's irrefutable.

[00:11:55] Speaker 00:
The bubbling method of disanes we know does not work.

[00:11:58] Speaker 00:
And we also know that the mixing method could not have created creatine nitrate.

[00:12:01] Speaker 00:
All of those points are unrebutted in the record.

[00:12:04] Speaker 00:
All of that is substantial evidence that it's not enabling.

[00:12:07] Speaker 00:
And the board simply looked at Thermal Life's method and said, because it's substantially identical and you haven't shown it to be substantially different, which was a wrong assumption, then it doesn't overcome the presumption of enablement, which they also had the higher level of clear error conclusive and necessary.

[00:12:28] Speaker 02:
You're into your envelope.

[00:12:28] Speaker 02:
I don't hear from the other side.

[00:12:39] Speaker 01:
May it please the court?

[00:12:43] Speaker 01:
Because this court needs to only affirm one ground of rejection, because claim six is rejected on three separate grounds, I'm going to focus on Barger.

[00:12:51] Speaker 01:
And Barger unambiguously discloses creatine nitrate, its correct chemical formula, and compares its solubility to other salts.

[00:13:00] Speaker 01:
DeSane and Gamelin both disclose a mixing method to make creatine nitrate.

[00:13:05] Speaker 01:
It's a very simple one-step method.

[00:13:07] Speaker 01:
Crystalline creatine is dissolved in nitric acid and the solution is evaporated Thermolife chose not to make the mixing method they chose not to have they have four experts none of them tried to replicate the mixing method Instead they spent a lot of time talking about the bubbling method But the board didn't rely on the bubbling method and it's not really relevant here Do you think that they had to replicate the mixing method in order to be able to prevail in this case?

[00:13:35] Speaker 01:
I think

[00:13:36] Speaker 01:
Yes, or they had to have some better evidence.

[00:13:40] Speaker 01:
What they have is just conjecture that the mixing method wouldn't work.

[00:13:44] Speaker 01:
There's an express disclosure that D'Sane's made creatine nitrate using the mixing method.

[00:13:51] Speaker 01:
So they had to do something to resolve that.

[00:13:53] Speaker 02:
When you say D'Sane's made creatine nitrate, is it because of the words creatine nitrate, or is it because of the formula, which was double the formula in the claimed invention?

[00:14:05] Speaker 01:
Both.

[00:14:06] Speaker 01:
I mean, Desain's had the double formula, but I want to, I want to.

[00:14:11] Speaker 02:
Yeah.

[00:14:11] Speaker 02:
And I also want to ask you a question about that double formula.

[00:14:14] Speaker 01:
Okay.

[00:14:15] Speaker 01:
But first I want to point you to 3927, which is a declaration by Mr. Dr. Chamberlain, who is their expert.

[00:14:24] Speaker 01:
And he says.

[00:14:26] Speaker 01:
Let me catch up with you.

[00:14:27] Speaker 02:
Okay.

[00:14:28] Speaker 01:
Thank you.

[00:14:37] Speaker 01:
It's paragraph 23.

[00:14:39] Speaker 01:
So nitric acid is NH03.

[00:14:42] Speaker 01:
But in the third sentence, when he's talking about disange, he says, one would assume that N2H2O6 would be two equivalents of nitric acid.

[00:14:52] Speaker 01:
So he's doing the same thing that the board did.

[00:14:55] Speaker 01:
And this is their expert.

[00:14:59] Speaker 03:
What about the point about the numbers in grams, the weight numbers not really jiving?

[00:15:07] Speaker 01:
So I think that is really almost irrelevant here, because the question is whether a person of ordinary skill in the art in 2007 could follow the instructions in disange and make creatine nitrate.

[00:15:22] Speaker 01:
Whether or not disange's numbers actually matched up using chemistry from 150 years ago, I think doesn't really matter.

[00:15:31] Speaker 01:
What you want to know is if somebody in 2007

[00:15:34] Speaker 01:
could read that one sentence dissolved 1.057 grams of crystallized creatine in nitric acid containing 0.447 grams of N2H2O6 and evaporated 86 degrees Fahrenheit.

[00:15:47] Speaker 01:
The question is whether somebody could do that and make creatine nitrate.

[00:15:52] Speaker 03:
And that's... This is going to be a slightly confused question, but one of the things that's been a little bit hard to keep straight here is the way

[00:16:02] Speaker 03:
in which, at least on Thermalife's side, the question of what was disclosed seems to bleed into how to make.

[00:16:10] Speaker 03:
And I guess increasingly have the feeling that there may not be such an independent how to make point being made on the other side as much as we really, there really wasn't substantial evidence to conclude that what is taught

[00:16:31] Speaker 03:
in terms of the compound, not how to make it in the three prior art references, is actually the same thing.

[00:16:38] Speaker 01:
Correct.

[00:16:38] Speaker 01:
And I think they mix the tests.

[00:16:40] Speaker 01:
Often in their brief, they say ambiguously enables.

[00:16:45] Speaker 01:
So they're kind of mixing whether or not a reference is ambiguous to whether or not.

[00:16:52] Speaker 03:
But I think Mr. Garris's point, and he can correct me if I'm wrong about this,

[00:16:58] Speaker 03:
One of the points he made this morning is that if you look at the weights, the gram measurements, that's a very good reason, particularly with his expert having so testified, to think that what was actually being disclosed there is not the same thing at all.

[00:17:17] Speaker 01:
But again, I don't think that's the right test.

[00:17:22] Speaker 01:
I think the test is whether or not a person could read the instructions on how to make it.

[00:17:27] Speaker 01:
and make it.

[00:17:29] Speaker 01:
That's what we're trying to figure out.

[00:17:31] Speaker 02:
But the thing that really puzzles me about that statement you've got is that you're saying how to make it.

[00:17:37] Speaker 02:
What if it isn't the same thing as what it's claimed?

[00:17:40] Speaker 02:
Then why are those instructions on how to make it even relevant?

[00:17:46] Speaker 01:
Because it's an express disclosure.

[00:17:48] Speaker 01:
It expressly says this is how you make creatine nitrate.

[00:17:51] Speaker 01:
And in order to rebut an express disclosure, you can't just have conjecture and say,

[00:17:55] Speaker 01:
Well, when I figured out the grant.

[00:17:57] Speaker 02:
But it's not just conjecture.

[00:17:58] Speaker 02:
The point is that what it's making might not be the same thing as what's in the claim.

[00:18:04] Speaker 01:
Right.

[00:18:04] Speaker 01:
But they never tried to make it to see if a person of skill could make it using this.

[00:18:10] Speaker 01:
Right?

[00:18:10] Speaker 01:
That's the test, whether in 2007.

[00:18:12] Speaker 01:
The test isn't whether actually or not DeSange made it.

[00:18:15] Speaker 01:
It's whether DeSange doesn't.

[00:18:16] Speaker 02:
What would they be trying to make?

[00:18:18] Speaker 02:
Would they be trying to make the formula that's disclosed in DeSange?

[00:18:21] Speaker 02:
Or would they be trying to make what's in the claim?

[00:18:24] Speaker 01:
So they would be trying to make creatine nitrate, which is what's in the claim, which is what Barger unambiguously discloses, both its name and its formula.

[00:18:36] Speaker 01:
And so that's the question, whether in 2007 someone could read these instructions and make it.

[00:18:41] Speaker 01:
It's not to go through disange and try and say, well, I see a discrepancy here because in the 1850s, whatever.

[00:18:53] Speaker 01:
He also says that gamelan teaches a way but gamelan also specifically teaches how to make creatine nitrate.

[00:19:03] Speaker 01:
Although in one place it does say if you use strong acid you get creatinine and if you use weak acid it's unaltered.

[00:19:10] Speaker 01:
He also has specific instructions how to make creatine nitrate

[00:19:14] Speaker 01:
using nitric acid.

[00:19:16] Speaker 03:
Just to be clear, on the Barger, did you point, Barger is it or Barger?

[00:19:21] Speaker 03:
I don't know.

[00:19:23] Speaker 03:
We can't ask.

[00:19:24] Speaker 03:
Barger, you say, expressly identifies the correct creatine nitrate.

[00:19:31] Speaker 03:
And this is by a combination of two things.

[00:19:34] Speaker 03:
One is the page 60 structure of creatine, which the examiner cited, I think, six times.

[00:19:44] Speaker 03:
as the structure for creatine.

[00:19:46] Speaker 03:
And I think in their August 2012 amendment expressly conceded was, in fact, the structure of creatine disclosed on page 60.

[00:19:58] Speaker 03:
And then you combine that with page 160 with the .8 NOH3.

[00:20:08] Speaker 01:
A couple things.

[00:20:09] Speaker 01:
So for creatine nitrate, it names it.

[00:20:12] Speaker 01:
it gives its correct formula.

[00:20:14] Speaker 03:
That's on the page 160, the C, blah, blah, blah.

[00:20:17] Speaker 03:
Right, it compares itself.

[00:20:18] Speaker 03:
And they made a point, I forget whether they make it here or just below, about the dot is used in Barger to refer to covalent bonds, not ionic bonds.

[00:20:28] Speaker 03:
And the examiner said, I don't think so, because a salt is always an ionic bond.

[00:20:32] Speaker 01:
Exactly.

[00:20:32] Speaker 01:
They don't make that in the reply, but they made that in their initial brief.

[00:20:35] Speaker 01:
Right, so Barger, we have

[00:20:36] Speaker 01:
Those three things, comparing its solubility, its formula, its name, and then also the structure of creatine is correct in Barker itself.

[00:20:45] Speaker 01:
The board copied the wrong structure.

[00:20:47] Speaker 03:
And so what you think is that the only thing that's left is how to make?

[00:20:50] Speaker 01:
It's how to make it.

[00:20:51] Speaker 01:
And we think to saints, this one sentence tells you how to make it.

[00:20:55] Speaker 03:
And that it may not be dispositive, but that it counts that they didn't try.

[00:21:02] Speaker 01:
I think it is dispositive because I think what they put forward is only conjecture and supposition as to what was going on.

[00:21:10] Speaker 03:
Did they have one of their experts who said, I'm just not remembering the record well enough, did they have somebody who said, well I didn't but I had a colleague

[00:21:21] Speaker 03:
who tried to do something quite like it, but you say it wasn't quite the same thing?

[00:21:25] Speaker 01:
Right, that was for the gas bubbling.

[00:21:26] Speaker 01:
Can you elaborate on that a little bit?

[00:21:28] Speaker 01:
So Desange has two different ways of making it.

[00:21:31] Speaker 01:
It has the gas bubbling and the mixing method.

[00:21:33] Speaker 01:
The board only relied on the mixing method.

[00:21:35] Speaker 01:
They never tried to make the mixing method.

[00:21:38] Speaker 01:
At all?

[00:21:38] Speaker 01:
At all.

[00:21:39] Speaker 01:
Oh, okay.

[00:21:41] Speaker 01:
He asked one of his colleagues to do the gas bubbling method.

[00:21:44] Speaker 01:
There's really no details.

[00:21:45] Speaker 03:
He just said... Okay, I was somehow misremembering that the colleague did a version of the mixing method.

[00:21:51] Speaker 01:
Right.

[00:21:52] Speaker 03:
That's not right?

[00:21:53] Speaker 01:
That's not right.

[00:21:53] Speaker 01:
The colleague only tried the bubbling method, and that's what most of their declaration is about.

[00:21:58] Speaker 01:
What they say about the mixing method is very, very minor.

[00:22:03] Speaker 01:
The other thing is the office did not use their

[00:22:08] Speaker 01:
disclosure to fill in gaps in the art, we basically, the board used their disclosure simply to explain, because one of their arguments is there's not a lot of detail for the mixing method.

[00:22:19] Speaker 01:
They don't have the concentrate, well, actually, Desaintes does have a concentration, but they say it doesn't talk about the ionic forms of creatine, how long you mix.

[00:22:28] Speaker 01:
And so what the board did was it looked to their patent specification to show that in 2007, those details weren't needed.

[00:22:36] Speaker 01:
Because actually, when you compare their patent specification to dis-ange and gamelan, they have less disclosure about how to make creatine nitrate.

[00:22:44] Speaker 03:
Can I ask you a question about some of the language that the board used in the two different places on what the prior references taught and then later on enabling words like clear error and conclusively and necessarily?

[00:23:00] Speaker 03:
Do you simply have to say that's all harmless error because

[00:23:06] Speaker 03:
The conclusions are sufficiently clear that, um, that, um, and it's perfectly clear the board would have drawn the same conclusion had it not used that language or how do you deal with that language, which doesn't seem quite right.

[00:23:22] Speaker 01:
So on a PPX 29, the board says twice that it's using preponderance of the evidence.

[00:23:29] Speaker 03:
Right.

[00:23:29] Speaker 03:
But it, but it, but it also says conclusively and necessarily.

[00:23:33] Speaker 03:
So you wonder a little bit about.

[00:23:34] Speaker 03:
what those words are doing there if they weren't actually part of the board's... Right.

[00:23:39] Speaker 01:
And so it is our position that because they're only putting forward speculation and conjecture, they would lose under any standard.

[00:23:48] Speaker 01:
So the fact that in one sentence they may have used the word conclusively, and maybe that wasn't an apt word to use, they didn't make their showing under the preponderance.

[00:23:59] Speaker 03:
What about the earlier references in the what

[00:24:02] Speaker 03:
the references taught part of the board's discussion.

[00:24:05] Speaker 03:
That's where I think the phrase clear error comes up at one point.

[00:24:09] Speaker 03:
Correct.

[00:24:11] Speaker 03:
It's just kind of a standard of review rather than an upbringing persuasion language.

[00:24:16] Speaker 01:
And I think that was simply saying that the reference taught something expressly, and they did not rebut that.

[00:24:28] Speaker 01:
That said, APPX 16 to 17.

[00:24:33] Speaker 01:
So what the patent owner was trying to say was the prior art on its face is factually incorrect.

[00:24:40] Speaker 01:
And what the board said in response to that is without sufficient evidence to support a finding of clear error.

[00:24:47] Speaker 01:
And I don't know that clear error is the right standard, but they have to show something to rebut an express factual statement in a reference.

[00:24:59] Speaker 01:
And that's got to be some kind of standard.

[00:25:01] Speaker 01:
Maybe Claire isn't the correct one, but.

[00:25:04] Speaker 02:
Can I ask you about a barger and the board's opinion about barger for a minute?

[00:25:08] Speaker 02:
Sure.

[00:25:09] Speaker 02:
In the board's opinion, they identified the incorrect structure for barger.

[00:25:16] Speaker 02:
Correct.

[00:25:16] Speaker 02:
And in your brief, you refer to the correct disclosures, which was cited by the examiner, I guess, in the examiner's answer before it went to the board.

[00:25:27] Speaker 02:
Maybe was it in the examiner's answer, I think, before the board's

[00:25:31] Speaker 02:
First opinion, I believe, is what you were citing.

[00:25:34] Speaker 01:
It's in the examiners.

[00:25:37] Speaker 01:
There's at least five times the examiners cited that.

[00:25:40] Speaker 03:
In the final rejection before the first.

[00:25:42] Speaker 01:
In the final rejection.

[00:25:43] Speaker 02:
Not the answer.

[00:25:45] Speaker 02:
Oh, thank you.

[00:25:46] Speaker 01:
And also.

[00:25:47] Speaker 02:
So my question is this, is that in the reply brief, one of the points that Thermal Life makes is that it would be improper for the B-tab

[00:25:59] Speaker 02:
you know, have relied on the examiner.

[00:26:01] Speaker 02:
The PTAB didn't in any way say it was incorporating anything in the examiner's rejection or anything in its answer.

[00:26:07] Speaker 02:
And so it would be improper for the PTO to now rely on what the examiner said when the board didn't adopt any of that.

[00:26:15] Speaker 01:
Well, first of all, the board also cites to those pages, which, and that's at APPX 9 and APPX 10.

[00:26:22] Speaker 01:
It also cites to Barger 69, which is that page, not for this specific point.

[00:26:27] Speaker 01:
Not for this point.

[00:26:28] Speaker 01:
they did cite to it.

[00:26:30] Speaker 01:
Also, the board is, unless they completely disavow something that the examiner said, it's assumed that that's part of what the board's reasoning is.

[00:26:41] Speaker 01:
Can I ask you this?

[00:26:43] Speaker 03:
In the board's first decision, the 2016 decision, the board does, I think, at 41-32 expressly adopt all the factual findings of the examiner and the final rejection and

[00:26:57] Speaker 03:
the answer, which I think would include all of the six references to page 69 on this specific point.

[00:27:11] Speaker 03:
What happened to the board's first decision after they introduced a new ground of rejection and went back down and came back up?

[00:27:22] Speaker 03:
Did the board's findings in the first decision

[00:27:24] Speaker 03:
remain part of what the board is deciding or did they go poof somehow?

[00:27:31] Speaker 03:
It's not a technical term.

[00:27:38] Speaker 03:
I mean, if they remain part of it, then it seems to me the board did actually adopt the examiner's specific findings about page 69 of Barger as the creatine, which, as I say, I think also the August 2012 amendment by Thermolife expressly conceives.

[00:27:59] Speaker 01:
Correct.

[00:27:59] Speaker 03:
Teaches the correct structure of creatine.

[00:28:01] Speaker 01:
Correct.

[00:28:02] Speaker 01:
And I mean, the board, as far as I know, never vacated that decision.

[00:28:06] Speaker 01:
So I assume that that is still part of it.

[00:28:08] Speaker 03:
Is there some ordinary course that we know what happens?

[00:28:13] Speaker 01:
I mean, I think in some cases, the board vacates an earlier decision.

[00:28:16] Speaker 01:
But they did not do that here, because basically, their analysis lines up.

[00:28:20] Speaker 02:
I mean, I think the term was reopened, right?

[00:28:22] Speaker 01:
Yeah.

[00:28:24] Speaker 01:
And so it's still part of the prosecution history.

[00:28:26] Speaker 01:
I think it's still.

[00:28:29] Speaker 01:
The board can still rely on it.

[00:28:30] Speaker 01:
And like you said, Thermolife agrees that barger itself has the correct chemical structure of creatine.

[00:28:37] Speaker 01:
And remember, that's creatine.

[00:28:39] Speaker 01:
That's the starting material.

[00:28:40] Speaker 01:
That's not creatine nitrate.

[00:28:42] Speaker 01:
So... Does barger disclose the structure for creatine nitrate?

[00:28:46] Speaker 01:
Not the structure.

[00:28:47] Speaker 01:
It doesn't have a diagram.

[00:28:48] Speaker 01:
but it has the formula and it has the name, and that's the unique identifier.

[00:28:52] Speaker 01:
There's no other compound that has both the formula and the name.

[00:28:58] Speaker 01:
So, I'm sorry, I'm over my time.

[00:29:15] Speaker 00:
Your Honor, just to start with the last part, Bartridge does not unambiguously disclose the correct formula for creatine nitrate.

[00:29:22] Speaker 00:
That formula also matches creatinine nitrate monohydrate, which if you look at the facts and the record and the evidence, that's more likely what DeSane produced.

[00:29:29] Speaker 00:
And the reason why he's more likely to produce that is because DeSane, the only one that the board relied on, the mixing method, used evaporation.

[00:29:36] Speaker 00:
And it's uncontested that evaporation dehydrates it and would create creatinine, not creatine.

[00:29:42] Speaker 00:
So that formula matches it.

[00:29:44] Speaker 00:
My friend from the PTO also said that Thermolife chose not to follow the mixing method into the same.

[00:29:51] Speaker 00:
And that's wrong.

[00:29:52] Speaker 03:
Can I just ask, I don't know enough of the chemistry.

[00:29:56] Speaker 03:
If you take as a given, as I think you conceded below, that the page 69 barger actual structure for creatine is shown, would then

[00:30:08] Speaker 03:
using the language creatine nitrate, assuming that the creatine there was a reference to that structure, still allow you to say that creatine nitrate would be covered?

[00:30:22] Speaker 03:
Or would that other piece of the formula have to change?

[00:30:26] Speaker 00:
Under Barger now?

[00:30:28] Speaker 00:
Yes.

[00:30:29] Speaker 00:
Theoretically, you could do that.

[00:30:32] Speaker 00:
And below, what Thermalife pointed out was that that formula still used the dots.

[00:30:36] Speaker 00:
And it also has a parentheses, which is meaningless nowadays.

[00:30:41] Speaker 00:
But what's unequivocal here is that the board did not find that as a fact.

[00:30:45] Speaker 00:
They didn't incorporate the examiner's reference as they had to.

[00:30:49] Speaker 00:
And if they wanted to rely on the prior decision, they knew how to do it, and they did it here.

[00:30:52] Speaker 00:
They cite it to the prior decision.

[00:30:54] Speaker 03:
What do you make of the 2016 board decision, which expressly adopts the examiner's findings about the teaching

[00:31:00] Speaker 00:
It shows that they didn't do it now in the opinion that matters because that opinion is essentially like a non-final office action.

[00:31:10] Speaker 00:
It doesn't mean that they expressly adopted it.

[00:31:12] Speaker 00:
They would have to expressly adopt it just like they did in that opinion, but they didn't.

[00:31:17] Speaker 00:
The evidence is not that Thermolife didn't choose to make the mixing method.

[00:31:21] Speaker 00:
Dr. Chamberlain said it was baffling and incomprehensible.

[00:31:24] Speaker 00:
But he also didn't stop there.

[00:31:26] Speaker 00:
He said the weights don't add up.

[00:31:28] Speaker 00:
That's irrefutable evidence.

[00:31:29] Speaker 00:
That's clear science that it doesn't work.

[00:31:32] Speaker 00:
It's irrefutable that the bubbling method doesn't work.

[00:31:34] Speaker 00:
And a posita would know all of this.

[00:31:36] Speaker 00:
And it's irrefutable that it says the same compound.

[00:31:38] Speaker 00:
And that it's known to a posita if you evaporate, if you dehydrate creatine, you're going to get creatinine nitrate, not creatine.

[00:31:45] Speaker 00:
So that, in context, DeSanes probably produced creatinine nitrate monohydrate, which is the same formula in Barger.

[00:31:53] Speaker 00:
But it still doesn't change the fact that there's those four clear points, including the teaching away in Gamelan, which the board still has not.

[00:32:03] Speaker 00:
The PTO now at least acknowledges a clear teaching away.

[00:32:07] Speaker 00:
So you have teaching away in Gamelan that is from Libig.

[00:32:09] Speaker 00:
Gamelan's at a compendium.

[00:32:11] Speaker 00:
That's from Libig, which came after DeSanes.

[00:32:13] Speaker 00:
And it said,

[00:32:15] Speaker 00:
No matter what you mix creatine with, you're not going to get creatine nitrate.

[00:32:18] Speaker 00:
You're going to get either creatine or creatinine nitrate.

[00:32:21] Speaker 03:
This is the weak, strong acid, weak acid point, which obviously there's a world between those two things.

[00:32:28] Speaker 00:
No, this is gummelin, your honor.

[00:32:29] Speaker 00:
So gummelin is teaching away at 4158.

[00:32:31] Speaker 00:
Gummelin is a compendium.

[00:32:33] Speaker 00:
So it recited disanes, and then it looked to Liebig to say that even Liebig disclosed that even if you mix creatine,

[00:32:42] Speaker 00:
with a strong acid, you're going to get creatinine.

[00:32:44] Speaker 00:
What about a weak acid?

[00:32:45] Speaker 00:
If you mix it with a weak acid, as they said in the next sentence, creatine is unaltered.

[00:32:50] Speaker 00:
You don't get a nitrate.

[00:32:51] Speaker 00:
You get nothing.

[00:32:52] Speaker 00:
That was a teaching that came after the saints.

[00:32:54] Speaker 00:
That's what one of Organic Skilling the Art would know.

[00:32:57] Speaker 00:
In addition to that, you have the unequivocal facts that Dr. Chamberlain said about

[00:33:04] Speaker 00:
The bubbling method doesn't work, and the mixing method doesn't work.

[00:33:08] Speaker 00:
And it's not conjecture.

[00:33:09] Speaker 00:
It's clear facts and clear science that the board has never addressed.

[00:33:14] Speaker 00:
Instead, what they said is this is substantially similar to Thermolife's method, but that's not true.

[00:33:19] Speaker 00:
And indeed, one of the most telling things is they say that it's simple high school chemistry.

[00:33:23] Speaker 00:
But nothing in the past 150 years was cited to support that.

[00:33:27] Speaker 00:
Thermalife instead overcame every single one of the modern references that the PTL put forward to show that a posita would simply mix the acid and base to create an amino acid salt.

[00:33:39] Speaker 00:
And that is very clear, and it's undisputed in the record.

[00:33:43] Speaker 00:
So it's undisputed facts and undisputed that there's nothing in 150 years that teaches otherwise.

[00:33:48] Speaker 00:
And the board's opinion is based simply on the say-so and its incorrect interpretation

[00:33:53] Speaker 00:
of Thermolife's method, which was different because of the water, different because of the crystallization.

[00:33:58] Speaker 00:
And indeed, in DeSane's, the only element, the only element, the only mixing method, or sorry, the only method that supposedly caused crystallization without the evaporation was the gas bubbling method, which is another reason why Thermolife focused on it.

[00:34:12] Speaker 00:
But it doesn't work as a matter of irrefutable, unrebutted science.

[00:34:20] Speaker 02:
Thank you.

[00:34:20] Speaker 03:
We thank both sides in the case's support.