[00:00:01] Speaker 00:
Our next case is 22-1889 Actilian Pharmaceuticals Limited versus MyLymph Pharmaceuticals.

[00:00:11] Speaker 00:
Counselor, we're linear.

[00:00:13] Speaker 00:
Is that correct?

[00:00:14] Speaker 00:
Yes, sir.

[00:00:14] Speaker 00:
All right.

[00:00:15] Speaker 00:
You got three minutes to vote on.

[00:00:17] Speaker 00:
Is that right?

[00:00:17] Speaker 04:
Yes, that's correct.

[00:00:18] Speaker 00:
OK.

[00:00:19] Speaker 04:
We're ready when you want.

[00:00:20] Speaker 04:
All right.

[00:00:21] Speaker 04:
Thank you, Judge, right now.

[00:00:21] Speaker 04:
And may it piece the court.

[00:00:23] Speaker 04:
This case is about the construction of the phrase a pH of 13 or higher in the context of the 802 and the 227 patents.

[00:00:32] Speaker 04:
It is not about the meaning of the number 13 in the abstract.

[00:00:36] Speaker 04:
The claim range here sets a precise floor at 13 that does not encompass lower values that might round up to 13.

[00:00:45] Speaker 04:
And each piece of the intrinsic record supports this.

[00:00:49] Speaker 02:
You emphasized a pH of 13 versus the number 13.

[00:00:55] Speaker 02:
Could you elaborate on that?

[00:00:57] Speaker 02:
Why do you think pH would have a different meaning?

[00:00:59] Speaker 02:
A pH of 13 would be different than 13 when it comes to the issue here, which is what are the significant digits, right?

[00:01:06] Speaker 04:
Well, it's because we're dealing, we're talking about the number 13.

[00:01:10] Speaker 04:
That's just an abstract number.

[00:01:12] Speaker 04:
when we're talking about pH of 13, and specifically a pH of 13 or higher, and I want to stress that point, that we're talking about the entirety of the claim term as a range.

[00:01:20] Speaker 04:
That's the context of what we're dealing with here in the patent, and that's what the skilled artisan is going to be reading in terms of figuring out the claim construction.

[00:01:30] Speaker 04:
So in terms of pH, yes, pH is sensitive, and if you actually go into the specification, you see that the inventor measured pH down to the tenth, if not to the hundredth of the unit.

[00:01:40] Speaker 04:
And that was particularly important for the purposes of this invention, given the variances that you could see with pH.

[00:01:48] Speaker 04:
pH was the key factor for this invention.

[00:01:52] Speaker 04:
So when you look at 13 and you say, oh, there's two significant digits that might round, I think the most important fact there is that

[00:02:00] Speaker 04:
That runs afoul of this court's decision in AstraZeneca, which says we don't look at numbers on the abstract to determine their meaning.

[00:02:06] Speaker 04:
And then it's just running afoul of basic principles of claim construction, where you're supposed to read it in the context of the intrinsic record.

[00:02:15] Speaker 02:
I thought maybe you were going to talk about the emphasis on pH.

[00:02:20] Speaker 02:
There are some textbooks in the appendix that I believe were cited before us and were cited before the district court below that say things like,

[00:02:28] Speaker 02:
How do you determine the number of significant digits in a pH?

[00:02:32] Speaker 02:
You count only the digits to the right of the decimal point.

[00:02:35] Speaker 02:
And that's like at page A339.

[00:02:41] Speaker 02:
What do we do with that in terms of, it doesn't seem that the district court really talked about it, but what do we do with that kind of disclosure?

[00:02:49] Speaker 02:
When we think about how a person of ordinary scale in New York would understand the plain language, a pH of 13.

[00:02:55] Speaker 04:
Well, I guess I have two responses to that, Judge Stoll.

[00:02:58] Speaker 04:
The first is that the textbooks are extrinsic evidence.

[00:03:01] Speaker 04:
And I think that the first place that the court needs to be looking under Phillips is to the intrinsic record.

[00:03:07] Speaker 04:
And when you look at the intrinsic record, I do not think there is anything here that would support reading and rounding into this term.

[00:03:14] Speaker 04:
And if I may, I'd like to start with the claim text.

[00:03:16] Speaker 03:
Can I just ask you before we move on to significant digits in a pH term?

[00:03:22] Speaker 03:
Is there anything in the intrinsic evidence that tells us how to figure out how many significant digits or significant figures there are in a pH term?

[00:03:30] Speaker 03:
Or do we have to get to the extrinsic evidence, if that's our question?

[00:03:34] Speaker 04:
Well, I think what the court's decision in AstraZeneca helps out here.

[00:03:38] Speaker 04:
And it says, look at the specification to determine the precision with which the inventor measured the variable.

[00:03:44] Speaker 04:
And as I mentioned at the top, that if you look at the examples in the specification, you see that the inventor did measure pH down to the 10th and even the 100th of the unit.

[00:03:58] Speaker 04:
And it simply wouldn't make sense to round away that level of precision by saying, oh, well, 13.

[00:04:03] Speaker 04:
There's only two significant digits there.

[00:04:06] Speaker 03:
And that's probably more important than what my question is, but I still would like some help with my question.

[00:04:11] Speaker 03:
The extrinsic evidence

[00:04:13] Speaker 03:
seems to clearly say for a pH value, the only significant figures are those to the right of the decimal point.

[00:04:22] Speaker 03:
That's all the extrinsic evidence you gave us seems to say that.

[00:04:26] Speaker 03:
Do you disagree with that being what the extrinsic evidence you gave us tells us?

[00:04:31] Speaker 04:
Well, we didn't give you extrinsic evidence.

[00:04:34] Speaker 03:
That's exactly right.

[00:04:35] Speaker 03:
I do believe that is a correct representation.

[00:04:37] Speaker 03:
So does it follow that a pH of 13

[00:04:42] Speaker 03:
with no decimal point and no figures to the right of the decimal point, that a pH of 13 has zero significant figures?

[00:04:50] Speaker 04:
I don't necessarily think that's the case, Your Honor.

[00:04:55] Speaker 04:
To have zero significant digits, I think there is still something to the 13, but it has to be read in the context of the claim language and the intrinsic record.

[00:05:06] Speaker 03:
So it seems that the district court expressly said that there are two significant figures in the claim term pH of 13.

[00:05:15] Speaker 03:
Correct.

[00:05:16] Speaker 03:
And it seems like both parties told the district court that as well.

[00:05:21] Speaker 03:
Is that right?

[00:05:24] Speaker 04:
I don't believe we focused on the significant digits as much as we focused on the claim language.

[00:05:32] Speaker 04:
I apologize here if this isn't quite getting at it, but I think the main focus here is that this is stated as a range.

[00:05:39] Speaker 04:
It's not just a pH of 13.

[00:05:40] Speaker 04:
It's a pH of 13 or higher.

[00:05:43] Speaker 03:
Let me ask this, and then I'll stop interrupting you.

[00:05:46] Speaker 03:
I'm here to answer your questions, Judge.

[00:05:49] Speaker 03:
If we have to determine how a person of ordinary skill in the art would understand the claim term pH of 13, do we have to know

[00:05:59] Speaker 03:
How many significant figures a person with a skill in the art would read into pH of 13?

[00:06:04] Speaker 04:
You don't, Your Honor.

[00:06:05] Speaker 04:
And the reason why is because it is a pH of 13 or higher.

[00:06:10] Speaker 04:
And this court has consistently read ranges like this, even when they use integers that sets a hard boundary at the whole number.

[00:06:21] Speaker 04:
So in the context of this claim term, the number to the left of the decimal, the whole number, needs to be 13 or it needs to be 14, which is the end of the pH scale.

[00:06:31] Speaker 04:
That was the upshot of this court's decisions in ticada, in generic, and in cobalt boats.

[00:06:37] Speaker 04:
And that makes sense when you think about it, because the main reason that we look for significant digits when we're measuring something in the chemical arts is we're making up for variances in the instruments, the lack of precision that an instrument might have.

[00:06:50] Speaker 02:
One thing I was going to say is that you're fighting these questions and I don't quite understand it because when I look at your position, for example, in your reply brief, you say that pH meters read to do two decimal places, 13.00, and you emphasize that with the .00 that any rounding that should occur would be at the

[00:07:17] Speaker 02:
What is it?

[00:07:18] Speaker 02:
100's position?

[00:07:19] Speaker 02:
Right.

[00:07:19] Speaker 02:
Round.

[00:07:20] Speaker 04:
Right.

[00:07:21] Speaker 04:
I guess you're, you're rounding away the thousandth, but yes.

[00:07:23] Speaker 02:
I don't, yes, but, but I guess I don't understand why you're fighting the idea that a person who already was killed in the art would only look at significant digits to the right of the decimal point, given your position.

[00:07:32] Speaker 04:
So it's not that I necessarily, I think that would be an alternative position of ours.

[00:07:36] Speaker 04:
And I think the reason I said that, if I may,

[00:07:39] Speaker 04:
is that our frontline position is that there's not a variance to be read into the 13 at all.

[00:07:45] Speaker 04:
I think when we start looking at the significant digit, that does raise the question of, well, what is the variance going to be?

[00:07:52] Speaker 04:
And if that's where we're going to go, Your Honor, then yes, I say there's two significant digits here.

[00:07:57] Speaker 04:
It's 13.00.

[00:07:58] Speaker 04:
That's what you were able to measure it to based upon this intrinsic record.

[00:08:02] Speaker 04:
And that also lines up with the extrinsic evidence.

[00:08:04] Speaker 02:
What if it's 13 with no significant digits?

[00:08:09] Speaker 02:
then I think there is nothing to the right of the decimal.

[00:08:13] Speaker 02:
I mean, that could be what it is too.

[00:08:15] Speaker 02:
I'm not saying, you know, I'm just throwing that out there.

[00:08:17] Speaker 04:
Sure.

[00:08:18] Speaker 04:
And actually, now that I understand it a little bit better, I think I actually do agree with that point because that really lines up with what is our main argument, which is that the 13 sets the barrier at the whole number.

[00:08:30] Speaker 04:
So 13.1 is fine.

[00:08:31] Speaker 04:
13.2 is fine.

[00:08:33] Speaker 04:
13.5 is fine.

[00:08:34] Speaker 04:
But that number on the left side has to be the 13.

[00:08:38] Speaker 03:
Is that what it would mean to say there are no significant figures in quote pH of 13?

[00:08:45] Speaker 04:
Um, I, I, I, I believe, I guess it could be your honor.

[00:08:48] Speaker 03:
I confess that we don't have anything in the record on that, do we?

[00:08:51] Speaker 04:
We don't, and I don't have a position on it, your honor, because our position is that we're reading the range, we're reading the totality of the claim term.

[00:08:58] Speaker 04:
And it sets that hard barrier at the whole number, which is what, uh, which is what happened to Cata.

[00:09:04] Speaker 04:
It's happened at what happened in generic and in cobalt.

[00:09:06] Speaker 02:
So in AstraZeneca, I think you referenced that case earlier.

[00:09:10] Speaker 02:
Yes.

[00:09:10] Speaker 02:
If there was rounding that had occurred, there was something in the specification that said there'd be a difference in stability within the range.

[00:09:22] Speaker 02:
So if you had the rounding, the bottom of the range would have

[00:09:26] Speaker 02:
would be almost excluded from the specifications.

[00:09:29] Speaker 02:
The specifications said that that bottom of the range at the rounding was less stable.

[00:09:35] Speaker 02:
There isn't anything like that in this case, is there?

[00:09:39] Speaker 04:
Well, I think, so to directly answer your question, no.

[00:09:42] Speaker 04:
There is no testing on values between 12.5 and 12.9, which is the value that my friend is trying to capture with his claim interpretation.

[00:09:51] Speaker 04:
It's at 12.0 and 13.0.

[00:09:55] Speaker 04:
And the patent makes the point that the testing that the samples at 12.0 performed had far less stability than the samples at 13.0.

[00:10:06] Speaker 02:
Does it actually say far less stability?

[00:10:08] Speaker 04:
Far less stability might be my gloss on it, but it did say that it performed worse.

[00:10:15] Speaker 04:
And that is at, I believe it is at appendix page 33.

[00:10:20] Speaker 04:
I know where it is.

[00:10:27] Speaker 04:
I can see it.

[00:10:28] Speaker 02:
I see where it says most preferably 13.

[00:10:35] Speaker 04:
So yes, so this is column 14, it's on appendix page 37 and I'm citing to the 802 patent here.

[00:10:44] Speaker 04:
Either the triosol or mannitol formulations with arginine at lower pH conditions.

[00:10:50] Speaker 02:
What lines are you at?

[00:10:51] Speaker 04:
My apologies, I am looking at lines, the sentence I'm quoting starts at line 31 and it goes down to line 33.

[00:11:03] Speaker 04:
And it says that either the triolose, I apologize if I'm mispronouncing that, or mannitol formulations with arginine at lower pH conditions, this is speaking less than 13.0, are less stable at 40 degrees compared to the pH 13 formulations.

[00:11:19] Speaker 04:
And I understand there that it is using the whole number, but it's important to point out that we're dealing with example four here.

[00:11:27] Speaker 04:
And that example is prefaced with the following sentence.

[00:11:35] Speaker 04:
The pH of the bulk solution for lyophilization is adjusted between 10.5 and 13.0.

[00:11:41] Speaker 04:
And that tells the skilled artisan that we are looking at these samples.

[00:11:46] Speaker 04:
We're measuring down to the 10th of the unit.

[00:11:47] Speaker 04:
We're capping it off at 13.0.

[00:11:50] Speaker 03:
Your friends on the other side contend that your position is that every number in the patents here that is not preceded by terms of approximation, like about or around or approximately, is a precise number with no rounding.

[00:12:03] Speaker 03:
Is that your position?

[00:12:05] Speaker 04:
I think that is the strong suggestion when you have an instance like this where some limitations have that language and other limitations do not.

[00:12:13] Speaker 04:
I'm not saying that is a per se rule, but it makes sense that when you use a word in some limitations and you don't use it in others, those without it lack that limitation.

[00:12:22] Speaker 03:
So if the contention is you are asking us to essentially read the word exactly or precisely into the plain language where it says a pH of 13, that you're essentially inviting us to read in the word exactly.

[00:12:34] Speaker 03:
to 13, you would say yes, that is essentially our position.

[00:12:39] Speaker 04:
I disagree with a little bit with reading in exactly

[00:12:45] Speaker 04:
And instead, I would rather phrase that, Your Honor, as we're not going to read in about or approximately, because those words are used explicitly elsewhere in the claim limitations.

[00:12:54] Speaker 02:
Is there a proposition that there can never be rounding unless the word about is included before the numerical number in a claim?

[00:13:02] Speaker 04:
No, Judge, still that is not our position.

[00:13:03] Speaker 04:
But our position is that when you use words approximation for some limitations and not others, that distinction has to mean something.

[00:13:12] Speaker 04:
And the court really made that point in generic.

[00:13:15] Speaker 02:
What, what about, you know, what if it meant the rounding like here, 12.5 to 13.4 and a little more when you say if you had about in front of it.

[00:13:26] Speaker 04:
Well, I think, and I apologize.

[00:13:28] Speaker 04:
I do see I'm starting to run into my.

[00:13:30] Speaker 04:
time, but I do want to quickly answer this question.

[00:13:33] Speaker 04:
I think that really does back into AstraZeneca, where we don't presume that the number itself rounds, and instead we have to find the evidence in the intrinsic record that rounding was intended.

[00:13:45] Speaker 04:
And I submit to you that on this intrinsic record, there is no such evidence.

[00:13:49] Speaker 00:
What about where the court refers to the specification

[00:13:54] Speaker 00:
of lesser preferable embodiments at about 12.5 and 13.5.

[00:13:59] Speaker 00:
And there's other references also to those numbers.

[00:14:04] Speaker 04:
So two responses to that, Your Honor.

[00:14:06] Speaker 04:
In most instances, they are referring back to ranges, which I think comes back to my point about how we read the ranges using the integers.

[00:14:13] Speaker 04:
And then I think the other important point is to recognize that this specification was written when Actilian was seeking a much broader claim pH limitation than what they actually got.

[00:14:25] Speaker 04:
The examiner conclusively rejected that broader claim limitation.

[00:14:34] Speaker 04:
and only allowed these patents under a showing of unexpected results using data at 13.0, and she specifically forced Actillion to trim back their pH limitation to match that data.

[00:14:47] Speaker 00:
So what are you saying?

[00:14:47] Speaker 00:
This is the language that was supposed to have been cleaned up or wasn't?

[00:14:52] Speaker 04:
That could very well be the case, yes.

[00:14:54] Speaker 04:
And in fact, we saw that in AstraZeneca.

[00:14:56] Speaker 04:
The court noted that, where we have a patent that goes through various iterations

[00:15:01] Speaker 04:
at the examiner's office, the limitation is forced to be carried back and just the inventor did not clean up the specification to eliminate those references to embodiments that were denied.

[00:15:14] Speaker 04:
So if the report doesn't have any other questions, I will reserve the remainder of my time.

[00:15:19] Speaker 00:
You don't have any time left.

[00:15:21] Speaker 04:
Thank you, your honor.

[00:15:28] Speaker 00:
All right.

[00:15:30] Speaker ?:
Yes.

[00:15:31] Speaker 01:
Thank you, Your Honor.

[00:15:36] Speaker 01:
May it please the court.

[00:15:38] Speaker 01:
The district court faithfully followed AstraZeneca.

[00:15:42] Speaker 01:
It properly started with the plain language and then looked to other intrinsic evidence to determine whether that ordinary meaning applied.

[00:15:51] Speaker 01:
And Phillips teaches that courts could consider sources in any sequence.

[00:15:57] Speaker 01:
And that would include starting with scientific conventions that a post-it would understand without explication in the patent.

[00:16:06] Speaker 01:
Indeed, Phillips itself began with a generic meaning of the claim term baffles and found that the intrinsic evidence confirmed that usage.

[00:16:16] Speaker 01:
So the district court did not presume that the ordinary meaning of pH of 13 was controlling absent disproof lexicography or disclaimer, as Mylan suggests.

[00:16:28] Speaker 02:
Given some of the textbooks that we were talking about earlier in the record and say that when you're looking at a pH and thinking about significant digits, you should only look at the numerals to the right of the decimal point.

[00:16:42] Speaker 02:
Yes, I saw that.

[00:16:43] Speaker 02:
Doesn't that inform this ordinary meaning that you're talking about?

[00:16:46] Speaker 01:
I think it does, Your Honor.

[00:16:47] Speaker 01:
There's also, I would note that that was not a disputed issue.

[00:16:52] Speaker 01:
It wasn't contested on appeal that there was any error in the district court's interpretation

[00:16:58] Speaker 01:
uh... significant figures uh... but an appendix four seven nine it does talk about how that is handled in the middle of uh... of page four seven nine it says uh... and this is talking about generally uh... with if you have three point nine four five times ten to the third you take the log of the answer you get ten point nine dot nine uh... five nine six and the order of magnitude is ten

[00:17:28] Speaker 01:
So that's where the pH is basically an order of magnitude.

[00:17:32] Speaker 01:
And there are a whole number of increments, because it's the negative log.

[00:17:37] Speaker 01:
But I think the key part is in terms of what did the inventor understand by saying a pH of 13, he did not say 13.0, which is a figure that would have 10 times the greater precision, and certainly didn't say exactly 13, which is not

[00:17:58] Speaker 01:
scientifically possible in the context of pH, because you're talking about measurement of billions of ions in a liter of water, of hydrogen ions, and determining their concentration.

[00:18:09] Speaker 01:
So they haven't offered an ordinary construction.

[00:18:12] Speaker 00:
But let's say 13.

[00:18:13] Speaker 00:
That's a pretty exact statement.

[00:18:16] Speaker 01:
That's right.

[00:18:18] Speaker 01:
But it has, I think, an ordinary meaning of including the rounding principles

[00:18:28] Speaker 01:
based on the choice of significant figures.

[00:18:30] Speaker 01:
And that's what's exact.

[00:18:32] Speaker 01:
It's a choice of two significant figures.

[00:18:35] Speaker 03:
So if it's based on the choice of significant figures, aren't we stuck with having to figure out how many significant figures are in, quote, pH of 13?

[00:18:42] Speaker 01:
Well, I think the pH scale, once it's converted into the logarithm, I think you can treat it as an ordinary number.

[00:18:48] Speaker 01:
And then round, as opposed to 13.0 or 13.00.

[00:18:55] Speaker 03:
I guess I'm confused because you put this extrinsic evidence in the record, and I certainly agree that often claim construction can be done without the extrinsic evidence, but here you put the extrinsic evidence in and it seems to, but help me if I'm wrong, it seems to indisputably say that the only figures that are significant for a pH are those to the right of the decimal, and there are none to the right of the decimal in your claim, right?

[00:19:21] Speaker 03:
That is true.

[00:19:21] Speaker 03:
So it follows, it seems to me, if we look at the extrinsic evidence, there are zero significant figures.

[00:19:27] Speaker 03:
Is that right as well?

[00:19:28] Speaker 01:
Well, I think in terms of when you have a particular calculation, you would treat it as the significant figures being from the ones to the right of the decimal place.

[00:19:43] Speaker 01:
But when you're talking about an invention that's described simply based on the pH scale, the question is if you had measurements that were to the right or to the left of that, because you're never going to get exactly 13.

[00:19:57] Speaker 01:
And I think if you look at what the specification teaches, it does identify the most preferred embodiment as a pH of 13.

[00:20:08] Speaker 01:
which is a whole number, and would have the ordinary meaning of a whole number.

[00:20:12] Speaker 01:
It then identifies the preferred range as being 12 and a half to 13 and a half.

[00:20:19] Speaker 01:
And so Mylan's construction would properly exclude a large part of the preferred embodiment.

[00:20:27] Speaker 01:
And the inventor uses whole numbers throughout the specifications to describe the pH values of the invention.

[00:20:35] Speaker 03:
How do we know that a person's skill in the art

[00:20:38] Speaker 03:
would round the whole number of 13 when it's a pH of 13.

[00:20:44] Speaker 03:
I don't mean 13 generally, I mean pH of 13.

[00:20:47] Speaker 03:
On what basis do we know that there would be rounding as a person of skill in the art would read that?

[00:20:54] Speaker 01:
Well, I think that one can infer that from the fact that you can't have exactly 13.

[00:21:02] Speaker 01:
That's not a determination.

[00:21:03] Speaker 03:
Well, first of all, is there any evidence to support that statement?

[00:21:07] Speaker 03:
It makes total sense to me that when you're dealing with small particles in the billions, you can't get an exact number.

[00:21:12] Speaker 03:
But I didn't see any evidence of that in our record, is there?

[00:21:16] Speaker 01:
Well, I think that's just a basic mathematical principle that an exact number is a countable number, a defined number.

[00:21:23] Speaker 01:
They're presumed to have infinite significant figures who really can't treat this as an exact number.

[00:21:30] Speaker 01:
And it did not use 13.0.

[00:21:33] Speaker 01:
He always used whole numbers, and that's true in the prosecution history.

[00:21:37] Speaker 01:
And the prior art was clear that for lyophilized compositions, the highest value of the prior art was 11.6.

[00:21:46] Speaker 01:
Uh, and the, uh, the examiner said in the prosecution history that was did not teach lyophilized composition, uh, beyond, uh, 12 or higher.

[00:21:59] Speaker 01:
And so I think that, that the, what was understood was that if it's with treated as a whole number of 13, you would do ordinary 13, uh, whole number rounding.

[00:22:13] Speaker 01:
And that's true, even though I do acknowledge your honor, the extrinsic evidence does say when you're actually converting the calculation pH, you treat the numbers to the right of the decimal place.

[00:22:27] Speaker 02:
I have a question for you.

[00:22:30] Speaker 02:
Like Judge Stark, I don't know what to do with this, because it is in the record.

[00:22:33] Speaker 02:
It was presented to the district court.

[00:22:35] Speaker 02:
It was part of the considerations.

[00:22:36] Speaker 02:
But I don't see where the district court analyzed it, grappled it, or even took it into consideration when reaching or claiming the charges.

[00:22:46] Speaker 01:
I think that's true, Your Honor.

[00:22:49] Speaker 01:
I think both parties treated the number 13 as having two significant figures.

[00:22:57] Speaker 01:
So that particular.

[00:22:59] Speaker 01:
part of the extrinsic evidence was not discussed by the district court.

[00:23:03] Speaker 02:
But it was introduced to the district court.

[00:23:05] Speaker 01:
It was introduced to the district court.

[00:23:06] Speaker 02:
That's correct.

[00:23:07] Speaker 02:
As part of the claim construction.

[00:23:08] Speaker 02:
Yes.

[00:23:08] Speaker 02:
Should the district court have considered it?

[00:23:11] Speaker 01:
I think the district court was certainly entitled to consider all the extrinsic evidence.

[00:23:17] Speaker 01:
But I think the district court's general approach in terms of what the specification and prosecution history would teach, because it is critical that the

[00:23:29] Speaker 01:
inventor did use whole number values even when recorded measurements were sometimes in two, three or four or significant figures with two decimal places.

[00:23:42] Speaker 02:
Do you agree that, you know, a person of ordinary is filming art would understand that the significant digits for a pH value are to the right of the decimal point?

[00:23:53] Speaker 03:
Yes, I would.

[00:23:57] Speaker 03:
Okay.

[00:23:57] Speaker 03:
And do you know

[00:23:59] Speaker 03:
If we were to say there are zero significant figures in the term pH of 13, what would that mean for rounding?

[00:24:06] Speaker 01:
I think we would say there is zero if you're talking about taking the actual measurement.

[00:24:13] Speaker 01:
But when you're talking about how many, once you're on the pH scale,

[00:24:17] Speaker 01:
there would be two significant figures.

[00:24:20] Speaker 03:
You treat it as a whole number.

[00:24:23] Speaker 03:
If it's possible to have zero significant figures in a number, which it seems logically it is from this extrinsic evidence, I just don't know what that means in terms of is there rounding, is there not rounding, and if there's rounding, what range would we round to?

[00:24:40] Speaker 03:
If we were to hold pH of 13 has zero significant figures, does that have any implication for rounding?

[00:24:48] Speaker 01:
Well, Your Honor, I think that number would be the order of magnitude.

[00:24:55] Speaker 01:
And therefore, as I pointed out, the order of magnitude is not trying to identify a point value.

[00:25:02] Speaker 01:
So you're trying to identify a range of values that are in that order of magnitude.

[00:25:09] Speaker 01:
And that's why I think the proper approach would be to treat pH scale as whole numbers around it.

[00:25:19] Speaker 01:
Your honor, I think the AstraZeneca is a very different decision from this case, because in AstraZeneca there was specific evidence, intrinsic evidence, that would say that the ordinary scientific conventions would not apply and that the inventor intended a narrower meaning, the excluded values within the rounding range.

[00:25:49] Speaker 01:
And those were essentially four points.

[00:25:53] Speaker 01:
One, that there was evidence that stability was altered in the fourth decimal place, not true here.

[00:26:00] Speaker 01:
Secondly, one of the values, 0.005%, was actually found to be among the least stable solutions.

[00:26:09] Speaker 01:
Third, the inventor particularly sparaged 0.005% as inferior.

[00:26:17] Speaker 01:
to the claim term 0.001%.

[00:26:20] Speaker 01:
And also, abandoned claims or amended claims to eliminate 0.005%.

[00:26:28] Speaker 01:
So there's no evidence here that would exclude the ordinary meaning of 13.

[00:26:35] Speaker 01:
And because it is a whole number, the examiner understood that the applicant only talked about amendments and allowability in terms of 13.

[00:26:47] Speaker 01:
And the showing was that there was unexpected results versus a pH of 12 or lower.

[00:26:57] Speaker 01:
So he never surrendered any values that would round up to 13.

[00:27:03] Speaker 03:
There are various places where the patentee says about or approximately.

[00:27:08] Speaker 03:
Your argument seems to be that we should read the word about or approximately or around into the claim term, which

[00:27:18] Speaker 03:
clearly does not expressly include those words.

[00:27:22] Speaker 03:
Why should we do that?

[00:27:23] Speaker 03:
Isn't the strong implication that the patentee knew how to say that and would have said it if he or she wanted to?

[00:27:28] Speaker 01:
No, Your Honor.

[00:27:30] Speaker 01:
Language of approximation like about serves a very different function.

[00:27:34] Speaker 01:
It allows contextual variation from an identified value.

[00:27:40] Speaker 01:
And it does so based on the nature of the technology, the patent, the knowledge of one's skill in the art.

[00:27:47] Speaker 01:
Rounding conventions

[00:27:49] Speaker 01:
are to determine what the expressed value means and what it encompasses, not variation from it.

[00:27:55] Speaker 01:
So all of those numbers are to a certain number of significant figures, that number.

[00:28:02] Speaker 01:
So it's 13 at two significant figures.

[00:28:06] Speaker 01:
uh... so they're very different and i think this court is also in in number of cases stacy uh... u s philips uh... adams respiratory has recognized that the claim terms as one it doesn't mean one point oh and one could encompass for example one point one so you're rounding as part of the meaning of the term and just different from about and so when in the in the blue brief uh... for example page five the

[00:28:35] Speaker 03:
Appellant says the district court's approach, which you're advocating, of course, would threaten to transform any integer and any patent into a broad range of values, even without words of approximation.

[00:28:47] Speaker 03:
And to that you say yes.

[00:28:48] Speaker 03:
That's exactly our position.

[00:28:51] Speaker 01:
No, Your Honor.

[00:28:51] Speaker 01:
I'm saying that that is generally the ordinary meaning of a number.

[00:28:56] Speaker 01:
That it's a measured value would include the scientific convention depending on the number of

[00:29:01] Speaker 01:
of significant figures.

[00:29:03] Speaker 03:
I think the implication of your position is the only way out of that is for the patentee to say we mean exactly or precisely the following integer.

[00:29:12] Speaker 01:
No, Your Honor, I think you would look to the context.

[00:29:14] Speaker 01:
For example, in the Viscese case, where it was below about 0.91 grams per cubic centimeter, the court said ordinarily that the scientific invention would apply

[00:29:31] Speaker 01:
But the prior art through the line at .910, those were not considered very low density copolymers.

[00:29:39] Speaker 01:
They were just low density copolymers.

[00:29:41] Speaker 01:
So there you didn't apply the convention.

[00:29:43] Speaker 01:
So you have to look at the usage

[00:29:46] Speaker 01:
in the patent to determine if it applies.

[00:29:49] Speaker 01:
But if you take their position, which is essentially if you use about anywhere, you can't have any rounding.

[00:29:55] Speaker 01:
Everything has to be an exact measured value, even where it's scientifically impossible, as in the case of pH.

[00:30:02] Speaker 00:
So what would a lexiographer do if he wanted the pH value to be 13 and nothing else and wants to prevent rounding up or consideration of significant figures?

[00:30:14] Speaker 00:
Is there something that

[00:30:16] Speaker 01:
what do you say what what is it in your view that could have been done if that's what the lecturer wanted to do well certainly they could make an indication that this is not to be a rounded value they could also you know use a more precise term like 13.0 or 13.0 that would have to be in 00 that would have to be in the claims they could do those type of things but generally that that's the ordinary meaning and so they have to disclaim the application of rounding up or

[00:30:46] Speaker 00:
consideration of the significant figure regime?

[00:30:53] Speaker 01:
No, I think you'd look to the overall context.

[00:30:55] Speaker 01:
You'd look to what the prior art disclosed, for example.

[00:30:59] Speaker 01:
And that's the difference between Viscasi and this case.

[00:31:01] Speaker 01:
Here, the prior art stopped at 11.6 for lyophilized compositions.

[00:31:07] Speaker 01:
And so there was no question of going to the prior art.

[00:31:11] Speaker 01:
So I think generally, the ordinary meaning would be the rounding convention.

[00:31:16] Speaker 01:
You can have lexicography, you could have disclaimer.

[00:31:20] Speaker 00:
In all cases or in cases just like this one involving pH values?

[00:31:27] Speaker 00:
Well, I think... I have a fear and I think to start referring to this, but I have a fear that your argument creeps into all our patent cases to a certain degree anytime that some sort of value is expressed.

[00:31:44] Speaker 01:
Well, Your Honor, I think, again, you would look at context.

[00:31:46] Speaker 01:
I think the court only has to decide the context of what does a measured value of pH mean when you're talking about tens of billions.

[00:31:55] Speaker 01:
I think that was at issue in AstraZeneca where the court recognized, at least in the abstract, when you're talking about measurement of very tiny particles,

[00:32:06] Speaker 01:
You know, the ordinary meaning would suggest... Council, I had a question.

[00:32:10] Speaker 02:
I want to ask you, I mean, your argument about claim destruction, everything about, you know, rounding of a number, that rests on the idea that as a matter of a plain meaning, a numerical value includes rounding, right?

[00:32:25] Speaker 02:
I mean, that is your argument.

[00:32:26] Speaker 02:
You're relying on the plain meaning of the numerical value 13.

[00:32:30] Speaker 01:
We rely on the fact that the ordinary meaning is 13, and that that's confirmed by the specifications used.

[00:32:39] Speaker 02:
For example, in the... Your starting point is the plain meaning, right?

[00:32:43] Speaker 02:
Starting point is the plain meaning, but it's also... And how a person of ordinary is filming art would understand the word 13.

[00:32:48] Speaker 02:
Yes.

[00:32:49] Speaker 02:
So that would apply in other cases where numerals are used, right?

[00:32:53] Speaker 01:
That's right.

[00:32:53] Speaker 01:
And I think it may be a fair point.

[00:32:56] Speaker 01:
The court may want to instruct the patent office to make a real determination about what are the significant figures here?

[00:33:05] Speaker 01:
What is actually the inventor entitled to?

[00:33:08] Speaker 01:
But I think that is what occurred here, that the examiner understood that the preferred embodiment was 12.5 and 13.5.

[00:33:19] Speaker 01:
would have understood that the term 13 would incorporate.

[00:33:23] Speaker 02:
I understand what you're saying.

[00:33:24] Speaker 02:
My concern is, I think you already know, is that I think it's not just 13.

[00:33:28] Speaker 02:
It's a pH of 13.

[00:33:30] Speaker 02:
And I have a concern that maybe where you start with the plain or with the ordinary meaning is a little bit different when the pH of 13 as opposed to the number 13.

[00:33:38] Speaker 03:
Right.

[00:33:40] Speaker 03:
Yes, I understand.

[00:33:41] Speaker 03:
Just one more.

[00:33:42] Speaker 03:
If we were to agree with the district court that pH of 13 is two significant figures,

[00:33:48] Speaker 03:
What does that mean for rounding?

[00:33:49] Speaker 03:
What does a pH of 13 with two significant figures round to, if anything?

[00:33:54] Speaker 01:
Well, it would be round from 12.5 to 13.4.

[00:33:57] Speaker 01:
OK.

[00:33:57] Speaker 01:
Thank you.

[00:34:00] Speaker 01:
And we think that is the plain meaning.

[00:34:03] Speaker 01:
And I would point out, for example, that the examiner relied on the stability of the reconstituted solutions.

[00:34:11] Speaker 01:
Those were from batches that were only described as adjusted to 13, not 13.0.

[00:34:17] Speaker 01:
And so that indicates that to the extent he had more precise values that he measured, he conceived of the invention as a matter of scientific inference as broader and stated his invention in those terms.

[00:34:31] Speaker 01:
And that should be the meaning that controls.

[00:34:34] Speaker 01:
Thank you.

[00:34:37] Speaker 00:
Thank you, Mr. Chancellor.

[00:34:42] Speaker 00:
Mr. Rehling, do you have three minutes?

[00:34:47] Speaker 03:
I just want to start just to see if we have agreement on a factual point.

[00:34:51] Speaker 03:
If we were to agree with the district court that PH of 13 is two significant figures, do you agree with your friend on the other side that that would mean we would round from 12.5 to 13.4?

[00:35:03] Speaker 04:
I do not agree with that because if we're talking about two significant digits on the right side of the decimal place, we are talking 13.00 and your rounding principle there would be down to 12.995, which is a point that we make in our reply brief.

[00:35:20] Speaker 03:
Well, you make it in terms of 13.00, but do you ever say the district court erred in saying that it's two significant figures in pH of 13?

[00:35:31] Speaker 04:
I don't think we said it in quite those terms, but I think where we disagreed with the district court is that insofar as there's rounding to be read into 13 at all, that it would be 12.5 to 13.4.

[00:35:43] Speaker 04:
We absolutely disagree with that point.

[00:35:46] Speaker 03:
But you never said, hey, district court, the only significant figures in pH of 13 would be to the right of the decimal point, and all the rounding would be to the right of the decimal point.

[00:36:00] Speaker 03:
You just let the district court say, PH of 13, that phrase in full is two significant figures, and you don't even point out on appeal that that was an error.

[00:36:11] Speaker 03:
So that's not really before us, is it?

[00:36:14] Speaker 04:
Again, I'm trying to be careful in answering your question, Judge Start.

[00:36:18] Speaker 04:
We did point out to the district court, I believe there was a supplemental brief that came down after this court's decision in AstraZeneca, where we said that if we are going to round this term, our main line was position is no rounding, period.

[00:36:31] Speaker 04:
But if there was going to be rounding, it's 13.00 and therefore the lowest value it's going to go down to is 12.995.

[00:36:38] Speaker 04:
We were very clear on that point.

[00:36:40] Speaker 04:
We included the pictures of the pH meters from the extrinsic record in order to make that point.

[00:36:47] Speaker 02:
And that points in your reply brief as well?

[00:36:49] Speaker 04:
That is in our reply brief to this court as well.

[00:36:51] Speaker 04:
And Your Honor, with my remaining time, one point I really want to hit on is that my friend acknowledged that at the core of his argument is the suggestion that the ordinary meaning of the number 13 includes rounding, just as an abstract principle.

[00:37:06] Speaker 04:
And I think that's exactly what this court rejected in AstraZeneca at 19F4, pages 1329 to 1330.

[00:37:14] Speaker 04:
It said that we do not.

[00:37:16] Speaker 04:
read rounding in as an abstract matter.

[00:37:18] Speaker 04:
And instead we look at the record to determine what the number means in the context of the full claim term and in the context of the specification.

[00:37:27] Speaker 04:
And that dovetails into my second point.

[00:37:29] Speaker 04:
The claim term that we're dealing with here isn't just APH of 13.

[00:37:33] Speaker 04:
It is APH of 13 or higher.

[00:37:35] Speaker 04:
So if you vary that down, if we vary that down to 12.5, as my friend is asking to do, you're really vitiating that term.

[00:37:42] Speaker 04:
You're vitiating the fact that it is a range that sets the hard point at 13.

[00:37:46] Speaker 04:
It tells you that there's going to be any variance.

[00:37:49] Speaker 04:
It's going to be upward, which I also think takes care of his point of the issues with measuring 13 with exactness.

[00:37:56] Speaker 04:
And then it also vitiates the fact that this claim term did not use about or proximately or plus or minus, despite the fact that such terms appear

[00:38:05] Speaker 04:
throughout the patent.

[00:38:07] Speaker 04:
With that, I see my time has expired.

[00:38:09] Speaker 00:
So if Mr. Court has any additional questions, we ask you to reverse and remand.