[00:00:09] Speaker 03:
Our next case for today is 2019-1163, Pharmatech Solutions versus LifeScan.

[00:00:38] Speaker 02:
May I please report John Schaefer on behalf of Pharmatech and Decision Diagnostics.

[00:00:43] Speaker 02:
This case suggests a new norm for prosecution history estoppel, both argument-based and amendment-based.

[00:00:51] Speaker 02:
With respect to amendment-based estoppel, the proposition is that if a limitation added by amendment is already found in the prior art to be overcome,

[00:01:01] Speaker 02:
then one knowledgeable in the art would know that the reason why the entire amendment overcame the prior art, its rationale, is only tangentially related to the equivalent of the added limitation that is contained in the prior art.

[00:01:18] Speaker 02:
Because the reason for adding a limitation was not motivated in that instance, adding that limitation was not motivated by any patentability concerns.

[00:01:29] Speaker 02:
With respect to argument basis, you have the same thing.

[00:01:33] Speaker 03:
So why do you argue the multiple measurements?

[00:01:39] Speaker 03:
Why do you argue it was added then?

[00:01:42] Speaker 02:
It's not the multiple measurements limitation.

[00:01:44] Speaker 02:
The limitation that we're arguing exists in the prior art is the converting limitation.

[00:01:50] Speaker 02:
There were three pieces to the amendment that's at issue.

[00:01:56] Speaker 02:
There was taking multiple measurements at different times, there was converting, and then there was comparing those measurements against each other.

[00:02:07] Speaker 02:
The one that's at issue here that the doctrine of equivalence would apply to is only the converting limitation, because there's no dispute that the accused device... Okay, so why was... Your argument basically is we should assume it wasn't added for patentability purposes.

[00:02:28] Speaker 03:
because if I understand your argument, we should assume it wasn't added for patentability purposes because the problem had already been overcome in the prior art, so therefore it must have been added for some other reason.

[00:02:37] Speaker 03:
What was the other reason?

[00:02:38] Speaker 02:
No, the reason converting was added is that in order for an electric current to

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disclose a analyte or to represent an analyte to be proportional to an analyte, you have to convert it.

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Electro biosensors exist because we know there's a known correlation between electric currents generated and an analyte.

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So converting is a necessary underlying element to any electrical chemical biosensor.

[00:03:11] Speaker 02:
And both the Zivinsky prior reference that was cited in connection with the amendments, prior to the amendments, and the White reference, they both specifically disclose converting.

[00:03:25] Speaker 02:
In fact, White itself talks about converting electrical currents and then summing those together and comparing them with an expected.

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So the whole idea of converting was known in the art.

[00:03:38] Speaker 02:
So you can't overcome it.

[00:03:40] Speaker 02:
It's obvious you can't overcome a prior art reference by citing something in that reference.

[00:03:47] Speaker 02:
You have to cite something new, different, or unique, and converting was in there.

[00:03:52] Speaker 03:
I guess I still don't understand.

[00:03:53] Speaker 03:
Why was the limitation added then?

[00:03:55] Speaker 02:
The limitation was added because in order to compare, what you have is you have a diffusion-limited reaction here.

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And over time, you can't simply compare them because a current measured at one time, at time A,

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and a current measured at time B, you're not going to know whether or not those are pointing to the same analyte reference unless you do the conversion.

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because the diffusion limited will show you that as time passes at the initial phase of the cut trail current.

[00:04:34] Speaker 04:
It sounds like you still thought it was important, an important thing that had to be in the claim, even with your explanation that you're providing.

[00:04:42] Speaker 02:
Yes, it's important because if you want to be able to compare

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measurements throughout the entire reaction period, you have to convert.

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But what the accused device does that's interesting is at the end of that reaction, there is no real difference anymore between the current being measured and the glucose measured in time.

[00:05:07] Speaker 04:
They directly correlate.

[00:05:10] Speaker 04:
Let me just tell you one of the problems I'm having with your argument.

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I'd like you to point me to evidence in the record, specifically in the prosecution history,

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When you look at the prosecution history, it looks like this was purposefully added to the claims.

[00:05:33] Speaker 02:
It was purposely added to the claims, but not to overcome the prior art.

[00:05:39] Speaker 04:
Show me how the prosecution history shows that this was added not to overcome the prior art.

[00:05:45] Speaker 02:
Well, if you look at page 66 of our blue brief, which is the opening brief, I'm showing you the... Okay, so you're going to show me references to the appendix that are in your blue brief.

[00:05:58] Speaker 02:
Exactly.

[00:05:59] Speaker 02:
What I'm showing you is a reference to white and the graphic in white.

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where White specifically takes multiple measurements, multiple glucose concentration measurements and compares them against an expected.

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So by us adding a converting limitation to our path to adding that limitation as an amendment, it could not have overcome the prior art.

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Can we look at page 307 and 308 of the appendix?

[00:06:33] Speaker 03:
Yes.

[00:06:35] Speaker 03:
Your patentee argued in remarks, I think, that it in fact overcomes Pullman.

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What am I missing?

[00:06:48] Speaker 02:
Because Pullman ultimately converts as well.

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You have Pullman, and you have Saminsky and Cohen.

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Pullman likewise does not suggest the present claimed means for comparing the concentration derived from the first measurement and at least one additional

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concentration derived from an additional measurement to verify the results.

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All claims now pending have been amended to include this additional feature.

[00:07:13] Speaker 02:
You're absolutely right.

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But the distinction in Pullman and Kohn and Zaminski is they were not taking multiple measurements over time and comparing them to determine whether or not there's an error.

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And the only way you can do that throughout the entire reaction period is to convert.

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if you just want to compare the currents, because if you compare currents at an earlier period of time,

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Those currents are going to be different, but you're not going to know if that difference is the result of the reaction or is the result that you're getting different analyte measurements.

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So you're absolutely right.

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Yes.

[00:07:52] Speaker 01:
So you added the comparing limitation in order to create a real-time comparison.

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A real-time comparison of measurements against each other.

[00:08:02] Speaker 01:
The Comcast device does not have a real-time comparison.

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And that's why you added this limitation, correct?

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The prior art did not compare measurements with each other.

[00:08:13] Speaker 01:
The only reference cited in the prosecution... You said before that the prior art did have comparing limitations.

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But they didn't have real-time comparison, and that's why you amended your claim.

[00:08:26] Speaker 02:
You're almost correct, Adrian.

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The distinction is the prior art, in particular white, took multiple measurements at different times, but used those measurements and compared them against an expected

[00:08:40] Speaker 02:
Cottrell curve so they weren't comparing the measurements with each other they were comparing them with an Expected and they do that both recurrence in white and they do that with glucose measurements they look at glucose measurements over different times and they compare them against the Expected and what we're saying here is no we're different we compare with each other and

[00:09:01] Speaker 01:
But in order to compare with each other, and this goes to Judge Stone's point... Not just compare with each other, we compare in real time.

[00:09:08] Speaker 01:
We compare in real time.

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And that's what you were seeking to achieve through your amendment.

[00:09:13] Speaker 02:
Comparing against each other in real time.

[00:09:15] Speaker 01:
In real time.

[00:09:15] Speaker 01:
No one else does that.

[00:09:16] Speaker 01:
And the Comcast device does not compare in real time.

[00:09:19] Speaker 02:
The LifeScan device compares in real time.

[00:09:24] Speaker 02:
What LifeScan is saying is we compare currents, not glucose concentrations.

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And the reality is those aren't the equivalent with each other until you get to the end.

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You cannot compare currents with each other during the early portion of the reaction, because you're not going to know if your difference is due to time or due to differences in analytics.

[00:09:50] Speaker 02:
You're absolutely right.

[00:09:52] Speaker 04:
Yes.

[00:09:53] Speaker 04:
Can I ask you a separate question, which is on page A398 of the appendix, this is with respect to walling.

[00:10:03] Speaker 04:
And here, you make the argument, those teaching in walling

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We'll utilize multiple measurements together to determine our proper analyte concentration.

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That operation in walling does not convert two different control current readings to first and second analyte concentration measurements and then compare the first and second analyte concentration measurements to each other.

[00:10:26] Speaker 04:
Why isn't this showing that you expressly distinguished walling based on this very limitation that you're saying you didn't add for purposes of distinguishing prior?

[00:10:36] Speaker 02:
Because walling takes multiple measurements and then gets a single measurement.

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It never compares measurements at different times.

[00:10:44] Speaker 02:
Walling converts.

[00:10:46] Speaker 02:
Walling absolutely has to convert those current measurements to get an analyte reading.

[00:10:51] Speaker 02:
What the patient wants to know is what is their glucose level?

[00:10:55] Speaker 02:
They don't want to know what current was generated.

[00:10:58] Speaker 03:
I don't understand.

[00:10:59] Speaker 03:
At page 398, what you said was the operation of walling does not convert to different control current readings.

[00:11:05] Speaker 03:
So what am I missing?

[00:11:06] Speaker 02:
You have to read the whole sentence.

[00:11:08] Speaker 02:
Because if you read the whole sentence,

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and compare them with each other.

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And the only way you could compare them with each other is to convert.

[00:11:18] Speaker 02:
And if you looked at the patent and suit, claim four, the way that claim is written is you get two, you take a current reading at time one, you take a current reading at time two, you then convert and you compare.

[00:11:33] Speaker 02:
So the equivalent we're talking about here is converting.

[00:11:38] Speaker 02:
And in order to be able to compare measurements taken at different times with each other, you need to... See, I've gone over my time, because I need to save something for rebuttal.

[00:11:50] Speaker 03:
Compare concentration measurements derived from a first measurement and at least one additional concentration derived from an additional measurement to verify the results.

[00:11:58] Speaker 02:
The accused product compares currents, but at a time when there is no distinction between currents at time and glucose measurements at time.

[00:12:09] Speaker 02:
So it's the equivalent.

[00:12:11] Speaker 03:
OK.

[00:12:13] Speaker 03:
All right.

[00:12:13] Speaker 03:
Save remainder of your time for rebuttal.

[00:12:16] Speaker 03:
Tell me how to save your last name.

[00:12:18] Speaker 00:
Good morning, Your Honor.

[00:12:20] Speaker 00:
We submit that this is a textbook case for prosecution history to stop it.

[00:12:25] Speaker 00:
There's no literal infringement in this case because LifeScan's system does not meet two limitations that were added to the claim by amendment for reasons of patentability.

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The limitations require converting separate current measurements to separate concentration measurements

[00:12:43] Speaker 00:
and then comparing those separate concentration measurements.

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Life scan system does not do any of that.

[00:12:50] Speaker 00:
Life scan system compares current rather than concentrations.

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If the two current measurements were sufficiently close to each other, it then creates a single concentration measurement which is not compared to any other concentration measurement.

[00:13:06] Speaker 00:
So there's no literal infringement.

[00:13:09] Speaker 00:
Pharmatech recognized that when it stipulated to dismiss its claims of literal infringement with prejudice.

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Pharmatech initially had disclaimed any intention to rely on the doctrine of equivalence, but after stipulating to dismiss its claims of literal infringement, then resurrected a doctrine of equivalence claim.

[00:13:27] Speaker 00:
The district court was correct in dismissing that claim.

[00:13:30] Speaker 04:
on summary judgment and concluding that any doctrine of equivalence claim is far better response to some of the positions taking here today about there being a distinction somehow because I'm not even sure if I can explain it properly but but there being a distinction how these statements about walling for example are not relevant in

[00:13:54] Speaker 04:
because we really should be focusing on the second clause that Walling doesn't convert to current readings and then compare the first and second analyte concentration measurements.

[00:14:09] Speaker 00:
What's your response to that?

[00:14:10] Speaker 00:
I think it's just a total misreading of what the applicants are telling the public.

[00:14:16] Speaker 00:
Your Honor asked opposing counsel about pages 398 to 399.

[00:14:21] Speaker 00:
The applicants are distinguishing the prior art there, and more importantly, they're telling the public what their present invention is.

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And they're saying loud and clear that their present invention is a system that converts two current measurements into concentration and then compares concentration, compares those two concentration measurements derived from the current measurements.

[00:14:44] Speaker 00:
That's what the invention is.

[00:14:45] Speaker 00:
They distinguish art that doesn't do both of those things.

[00:14:49] Speaker 00:
And that distinction is equally applicable to a life scan system, which does neither of them.

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So they're explaining what the reason for the amendment is.

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And that reason to define their present invention and distinguish the prior art is equally applicable to life scan system.

[00:15:06] Speaker 00:
It's interesting, Your Honor, if you look at what preceded the interchange of 398 and 399,

[00:15:12] Speaker 00:
At page 384 of the appendix, there's a discussion of White.

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And White, Pharmatech had tried to distinguish White in response to an earlier rejection by arguing that White is different from the present invention because White uses a complicated mathematical ratio and that complicated mathematical ratio is different from the straightforward system that Pharmatech's invention uses, that the applicant's invention uses.

[00:15:42] Speaker 00:
And at page 384, the examiner considered that argument and said it's unpersuasive.

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And the examiner then goes on to say,

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that while white compares readings using this mathematical ratio, white nevertheless compares the current readings to determine whether it's proper.

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So the examiner is saying that white compares current.

[00:16:08] Speaker 00:
The applicants respond to that at 398 and 399 by saying that white is completely different from their invention because the present invention compares concentration rather than current.

[00:16:22] Speaker 04:
That's you're pointing to like the fifth line from the bottom on page 398.

[00:16:30] Speaker 00:
The whole last paragraph.

[00:16:32] Speaker 00:
Continuing over to 399.

[00:16:35] Speaker 00:
And in fact, if you look at page 398, if you look at the argument, the applicant's argument starting at the bottom of page, the last line on 397, and then continuing over to the middle of 399,

[00:16:49] Speaker 00:
In those two pages, the applicants 12 times tell the public that their present invention is a system that converts current to concentration and then compares the actual concentration measurements.

[00:17:04] Speaker 00:
They do that eight times in two pages.

[00:17:09] Speaker 00:
If you look at page 378 and 379, they do that four times in two pages.

[00:17:15] Speaker 00:
And those statements are telling the public in the clearest possible terms that this invention is a system that converts separate current measurements to separate concentration measurements

[00:17:31] Speaker 00:
and then compares the separate concentration measurements.

[00:17:34] Speaker 00:
They're telling the public what the invention is and they're telling the public what the invention is not.

[00:17:38] Speaker 03:
Yeah, but that argument is almost like saying there is no tangentiality exception.

[00:17:42] Speaker 03:
I mean, the tangentiality exception presupposes that the sentence would otherwise be an estoppel.

[00:17:51] Speaker 00:
I beg to differ with that, Your Honor, and what makes this different.

[00:17:55] Speaker 03:
What case would you point me to that says that's not the case?

[00:17:59] Speaker 00:
What I point you to, Your Honor, is that the statements that we're talking about at 378 and 379 and 398 and 99 make this case the polar opposite of the case that this court decided in August in Eli Lilly.

[00:18:13] Speaker 00:
In Eli Lilly, what the court did is look to see what the present invention was.

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and it found that the invention did not exclude the accused device.

[00:18:28] Speaker 00:
Here you have a statement that the limitations added by amendment aren't just distinctions, they are actually defining the present invention.

[00:18:39] Speaker 00:
And that's very, very different.

[00:18:41] Speaker 00:
What it does, Your Honor, it makes this a stronger case for prosecution history estoppel than any other case that this Court has ever considered.

[00:18:50] Speaker 00:
I'm not aware of any case where an applicant amended his claims and then specifically pointed to the language of the amendment to say the language that I've added by amendment

[00:19:00] Speaker 00:
That's my invention.

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And that's exactly what the applicants did here.

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It's extremely unusual for an applicant to add limitations and then say, what I've added is my invention.

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And having said that to the public,

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I don't think the applicants can then escape what they're telling the public without doing notice to the public notice function in the prosecution history.

[00:19:22] Speaker 00:
The public's entitled to rely on what the applicants are telling the public in the prosecution when they say, my invention is a system that does this.

[00:19:32] Speaker 00:
When you tell the public, my system, my invention is a system that converts separate currents into concentrations and then compares the separate concentrations.

[00:19:42] Speaker 00:
After you tell the public that, you then can't turn around and try to recapture through equivalence what you've disclaimed.

[00:19:49] Speaker 00:
And this case is on all fours.

[00:19:52] Speaker 00:
The clearest case, you know, the clearest case would be Judge Dyke's decision in pods where the applicants repeatedly said, my invention is

[00:20:03] Speaker 00:
a rectangular structure.

[00:20:06] Speaker 00:
And if a structure is not rectangular, then it's not my invention.

[00:20:10] Speaker 00:
And then the applicants tried to turn around and assert their claim against a non-rectangular structure.

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And this court said, no, you can't do that.

[00:20:18] Speaker 00:
You've told the public that your invention is a rectangular structure.

[00:20:20] Speaker 00:
You can't then turn around and assert your claims against a U-shaped structure.

[00:20:26] Speaker 00:
And that's exactly what they're trying to do here.

[00:20:28] Speaker 00:
They say loud and clear that their invention is a system that converts current to concentration, then compares concentration.

[00:20:37] Speaker 00:
The public's entitled to rely on that, and they then can't turn around and seek to reclaim what they've disclaimed.

[00:20:45] Speaker 00:
I think that's the real essence of...

[00:20:50] Speaker 00:
of what we have here, and that is what they're trying to do, I think.

[00:20:55] Speaker 00:
These statements at 398 and 399 in particular tell the public loud and clear what the rationale for the invention is.

[00:21:04] Speaker 00:
The rationale is to tell the public what the applicants actually invented, a system that compares, that converts two separate currents to two separate concentrations and then compares the concentrations.

[00:21:16] Speaker 00:
and to distinguish references that don't do that, references like white and like life scan system that compare current rather than concentration.

[00:21:31] Speaker 00:
And for the same reasons, again, as in pods, those same statements create an argument-based estable that bar the applicants from seeking to recapture what they surrendered during prosecution.

[00:21:44] Speaker 00:
I'm happy to answer any other questions that the court may have.

[00:21:47] Speaker 00:
But otherwise, we'll rest on what we have in our papers.

[00:21:51] Speaker 03:
Thank you, counsel.

[00:21:52] Speaker 03:
Mr. Schaefer, you have some rebuttal time.

[00:21:56] Speaker 02:
I noticed that Erskine didn't respond to the basic premise of this argument here, which is the converting element is in Siminski and in White.

[00:22:07] Speaker 02:
Councilman spoke when he said White compared currents with each other.

[00:22:11] Speaker 02:
It doesn't.

[00:22:12] Speaker 02:
White takes multiple currents at different times and compares them with an expected.

[00:22:17] Speaker 02:
White also takes multiple current measurements, converts them to glucose measurements, and compares them to an accepted.

[00:22:26] Speaker 02:
It doesn't matter what the public thinks when they read this.

[00:22:29] Speaker 02:
It matters what a person of ordinary skill in the art would think.

[00:22:33] Speaker 02:
And everyone in the art knows you must convert.

[00:22:37] Speaker 02:
The converting element when you look at the chart is a necessary element to be able to compare measurements over time.

[00:22:46] Speaker 02:
So it had to be in there.

[00:22:48] Speaker 02:
It had to be added, but it did not need to be added for the reasons why the tangential exception doesn't apply.

[00:22:56] Speaker 02:
It was not added to overcome the prior part because it could not overcome the prior part because that limitation was specifically in the

[00:23:07] Speaker 03:
just to be clear when you say everyone in the prior art knows you have to convert first and

[00:23:13] Speaker 03:
Is that something that's in the record, or is that attorney argument?

[00:23:17] Speaker 02:
If anything, it's how electrochemical biosensors work.

[00:23:22] Speaker 03:
According to you, my question was, is it in the record somewhere that everyone in the art knows this is the first step that has to occur?

[00:23:30] Speaker 02:
What I would look at is in our conversion element, when we added the conversion element, the prosecute, the... You purported

[00:23:39] Speaker 03:
to make a statement about what a skilled artisan would know.

[00:23:42] Speaker 03:
And I'm asking, is there record support for that?

[00:23:44] Speaker 02:
Yes.

[00:23:45] Speaker 02:
And what I would refer to is, if you look at appendix 339, in response to the amendment, the examiner repeatedly says, it compares currents.

[00:23:58] Speaker 02:
Because the examiner knows that the conversion element, that no one ever cited the conversion element.

[00:24:05] Speaker 03:
So the examiners say it compares currents.

[00:24:06] Speaker 03:
I'm supposed to subsume for that that that is record evidence to support your statement that every skilled artist knows you have to convert.

[00:24:13] Speaker 02:
And I would look at the prior art because every single one of the prior art references converts.

[00:24:20] Speaker 02:
because in order to get an analyte measurement out of a current measurement, you have to convert.

[00:24:27] Speaker 02:
So you can look at Pullman, you can look at Cohn, you can look at Zeminski at 331, where we specifically say Zeminski converts.

[00:24:35] Speaker 02:
It says specifically on 331.

[00:24:38] Speaker 02:
Zaminski states only that the device measures current at specific time points during the Cottrell current decay and then those current values are used to calculate the analyte concentration, i.e.

[00:24:50] Speaker 02:
convert.

[00:24:51] Speaker 02:
Zeminski converted, so there is no possible way.

[00:24:55] Speaker 02:
So your honor, there's two ways we're looking at this.

[00:24:58] Speaker 02:
One is, was it just a normal, a known feature?

[00:25:03] Speaker 02:
And I refer your honors to your SRI opinion, which we cite in our brief, which says, look, if the element was in the prior art, then it can't happen.

[00:25:15] Speaker 02:
It was a known existing feature in the art.

[00:25:18] Speaker 01:
Yes.

[00:25:21] Speaker 01:
And you left me unsatisfied with the answers when I was asking you about this.

[00:25:27] Speaker 01:
The claim was amended in order to enable this safety check type feature, correct?

[00:25:35] Speaker 01:
Yes.

[00:25:36] Speaker 01:
And what made the patent now different from the priority was that you had a real time comparison.

[00:25:43] Speaker 02:
Absolutely, we had a real-time comparison of two measurements made at different times.

[00:25:47] Speaker 02:
So that allowed you, that gave you some certainty that the measurement you got was right.

[00:25:53] Speaker 02:
And you need to address this.

[00:25:54] Speaker 01:
So you know you disavowed everything except for a real-time comparison.

[00:25:58] Speaker 02:
Exactly.

[00:25:59] Speaker 02:
The real-time comparison is the inventive element.

[00:26:02] Speaker 02:
And while I understand, I think I've gone over my time, while I understand you have to look at each element, our argument is very simple.

[00:26:08] Speaker 02:
If the element added was added for reasons unrelated because it was already in the prior art, it cannot, the equivalent of that cannot be anything but tangential.

[00:26:22] Speaker 02:
Thank you.

[00:26:23] Speaker 03:
OK.

[00:26:23] Speaker 03:
I thank both counsels for cases taken under submission.