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Three of five cases on the calendar this morning.

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Two patent cases from district courts, a trademark case from PTO, employee case from the MSPB, and claims case for the federal claims that is being submitted on the briefs and not being argued.

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The first case is Cleveland Clinic versus True Health Diagnostic 2018.

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1218.

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Mr. Rosenberg.

[00:00:52] Speaker 01:
May it please the Court.

[00:00:54] Speaker 01:
Far from being conventional, as the PTO found, the prior art taught away from the claimed laboratory methods in this case.

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The district court ignored that, and its ruling should be reversed for two reasons.

[00:01:07] Speaker 00:
Sounds like 103.

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Well, there's certainly overlap, Judge Luria, as I think a number of judges of this court have noted, between Alice Step 2 and 103 analysis.

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And in this case, the district court committed two errors with regard to Step 2.

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The first was that there were material issues of fact in dispute.

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And under this court's rulings in Berkheimer and Atrix, they should have prevented judgment on the pleadings.

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And so look, the clamor sites are contacting a sample with an antibody.

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Spectrophotometrically detecting, which is not really a transformative step.

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And then comparing, comparing and identifying.

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These sound pretty abstract.

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And they're not much different from the previous case.

[00:02:02] Speaker 01:
Well, I think they are very different, Judge Lurie, from the previous case.

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First and most critically, these are laboratory method claims.

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They do not include a diagnosis or prognosis element like the claims in the Ohio case and like claim, excuse me, example 29, claim two of the PTO guidelines.

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These are like example 29, claim one, that are almost identical to the claim

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in the 065 patent that's at issue.

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But example 29 is maybe your best argument, but that is not binding on us.

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It isn't binding, but what it does deserve is Skidmore deference.

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And the court failed to do that.

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The court, in its analysis, stated that the standard for deference was the standard for Chevron deference, publication in the Federal Register and notice and comment, not the standard for Skidmore deference.

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And we don't believe that the district court gave the guidelines or the PTO's interpretation of the guidelines

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Skidmore deference, and that's particularly relevant with respect to step two of Alice, because the PTO carefully analyzed the guidelines, the prior art, and held that these claims were innovative, were certainly not conventional or routine.

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And the district court virtually entirely ignored that in its opinion.

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The only time it even mentions the prior art is a summary footnote saying that it didn't think the prior art found these things innovative, never analyzed what the PTO had said,

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It never went through the Skidmore analysis of determining how persuasive the PTO's analysis was, why it should or shouldn't be relied upon, and how it applied in this case.

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At least at step two, Judge Laurie, the district court didn't do what it was supposed to do under Skidmore.

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And given that the guidelines are entitled to Skidmore deference, we believe that is a reversible error in and of itself.

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There were plainly material issues of fact about whether this, these laboratory methods used for this purpose were conventional or routine.

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In the blue brief at 56, you say, the methods claimed in the MPO lab method patents do not simply observe or detect a natural law.

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The correlation identified by the court depends upon the techniques used to measure MPO.

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Yes.

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And in the, in the, at 49, you say,

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Whether the detected MPO will be elevated depends on the techniques used to detect it.

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Even when using the prior diagnostic test, do you agree that MPO levels are in fact elevated in a patient at risk of cardiovascular disease, but the prior test simply would be ineffective at detecting?

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No.

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I don't agree with that, Judge Wallack.

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Because what the prior art taught and was so critical here is that you can look at MPO a variety of ways.

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And in most ways you look at it, you're going to find MPO in the blood lower in patients who are having cardiovascular disease or cardiovascular events.

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When you use this technique.

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But it's still up there, right?

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Not necessarily.

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This technique simply gives information that a physician or an ultimate diagnostician can use to try to make treatment plans.

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It's not 100%.

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It's very different from like the DNA cases like Ariosa, where it's either there or it isn't.

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Here, in some patients, MPO never gets elevated, no matter what their risk of cardiovascular disease is.

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It's definitely not an all or nothing thing here.

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And all this is doing, and I acknowledge this is not a method of treatment claim like the Vanda case, but it's similar, because this is not an all or nothing proposition.

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And what these laboratory patents do, unlike the Ohio patents, which have the diagnosis element, these simply give physicians the information

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They need, along with a whole lot of other information about an individual patient, whether to prescribe diet and exercise, medication, invasive procedures.

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I'm not sure your argument helps you in getting away from laboratory techniques of the previous patent and saying this provides information.

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Yeah.

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That's hardly helpful when the issue is abstract idea or law of nature.

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Well, it is helpful because the technique itself is innovative for this purpose.

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It's very much like the exergen case, we believe.

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In the exergen case, there was... You say the technique is innovative.

[00:06:22] Speaker 04:
I don't see how it's innovative.

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This is just the same technique that's been used for a million other diagnostic kits.

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You just figured out that it's useful in determining elevated MPO, right?

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With respect, that's not quite true, Judge Moore.

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So what is it?

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spectrophotometric detection that's innovative?

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Where is the inventive portion of the process?

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So a lot of it's in the specification.

[00:06:52] Speaker 04:
No, in the claim.

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In the claim, it's the combination of the elements.

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And the combination of the elements, when you look at even the detecting the antibody and contacting it, when you look at the specification, it talks about the way the ELISA, which this relates to, was done.

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At page 1751 of the appendix, for example, there are statements in the provisional application.

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Doesn't the spec say MPO activity may be determined by any of a variety of standard methods known in the art?

[00:07:24] Speaker 01:
In the summary of invention, yes, but that doesn't relate to the specific lab method claims at issue here.

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And in the Ohio case, you didn't have specific lab method claims like these.

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These are much more detailed, have step by steps analysis of the method.

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The point is,

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The ELISA in this case was custom-made after many months of research.

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And the only reason that isn't clearly established in the record is because there was no factual development.

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But it explains that in the provisional application.

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There's more statements about that in the specification.

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I'm sorry.

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What's the language in the claim that you, either of the 065 or the 597, that you're claiming is this innovative aspect?

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Because this just seems

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on all fours for me with whether it's Ariosa or Mayo.

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I mean, this is just a diagnostic kit, and I don't see anything different.

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And your spec itself says you're using standard prior art methods to do these things.

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So I really don't see anything.

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Tell me precise language in the claim and why that is really pointing to something that is innovative apart from the abstract idea itself, which can't be the innovative.

[00:08:35] Speaker 01:
Right.

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So first of all, in the 065 patent, it's the steps

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of obtaining the plasma sample, detecting elevated NPO.

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Give us a reference.

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Sorry.

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So I'm talking about claim one of the O6Y patent, right?

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So claim one talks about obtaining the plasma sample from the human patient having arteriosclerotic CBD.

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That itself is something that was taught away from in the prior art.

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The prior art said that's going to be worthless.

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Then you detect an elevated NPO mass in the plasma sample.

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That also, taught away from by the prior art,

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And then you have the control methodology to control against the general population or apparently healthy subjects.

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And the spec explains that that control methodology, in example one of the specification, is done through this iterative process.

[00:09:23] Speaker 04:
I'm sorry, where is the control methodology in claim one?

[00:09:26] Speaker 04:
I don't see that.

[00:09:27] Speaker 01:
It's in claim one B. It talks about as compared to a control MPO mass level.

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And that control MPO mass level is discussed in the specification in example one.

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And the methodology in example one uses this iterative process where you take, in this case, thousands of samples analyzed through this lab method to create a control curve.

[00:09:50] Speaker 04:
Aren't you just detecting whether something's elevated by comparing it to a control?

[00:09:54] Speaker 04:
What am I missing?

[00:09:55] Speaker 01:
No.

[00:09:56] Speaker 04:
It looks like you've just chosen a control level and you're comparing it

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the sample you have to decide if it's more higher than the control.

[00:10:03] Speaker 01:
Yeah, but the control methodology is explained in detail in the specification.

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And the way it has to be done to be effective is to actually use a very significant number of samples with this particular lab methodology to create the control curve.

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It's not something that exists out there.

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It's not a pre-printed reference.

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It's not a standard reference.

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And it varies through time.

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As you get more and more samples,

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the control methodology changes.

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And example one in the spec explains all of that.

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So just there, each of the different elements may in isolation be conventional, but the combination and using it for this purpose was distinctly taught away from by the prior art.

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And so in that case, it's not routine and conventional.

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And explaining Judge Moore or understanding each of these elements, how they fit together, and what an ordinarily skilled artist would understand

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is why factual development was necessary.

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Maybe this is a case that could have been disposed of at summary judgment after there was expert testimony and there was a full record that was developed.

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But this was done at the pleading stage.

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And it was done because the district court misinterpreted this court's decision in the Ohio case as resolving any and all issues.

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But these are lab method claims.

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They are different.

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As the court in the Ohio case specifically said, that lab method claims may be treated differently from diagnosis and prognosis claims.

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The PTO guidelines do the same thing in example 29.

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They treat claim one and claim two very differently.

[00:11:32] Speaker 04:
I guess I'm struggling to understand or appreciate what about claim one of the 065 patent is somehow a lab method claim as opposed to simply a diagnostic kit type claim.

[00:11:46] Speaker 01:
Because there's no diagnosis element to it, and because the step- Wait, wait, wait.

[00:11:50] Speaker 04:
Aren't you diagnosing an elevated MPO mass?

[00:11:53] Speaker 01:
No.

[00:11:53] Speaker 04:
Isn't that what you're diagnosing?

[00:11:54] Speaker 01:
No, you're detecting an elevated MPO mass in patients that already have been diagnosed as having CVD.

[00:12:01] Speaker 01:
There's no diagnosis element here.

[00:12:03] Speaker 04:
I fail to appreciate the difference between detecting and diagnosing.

[00:12:08] Speaker 04:
I don't.

[00:12:09] Speaker 04:
detecting elevated MPO mass because you found that correlates to something important.

[00:12:14] Speaker 01:
You're detecting MPO mass because it gives information to the physician that the physician can use for treatment, but it's not diagnosing a condition.

[00:12:22] Speaker 01:
It's not saying you have CVD because of this.

[00:12:26] Speaker 04:
When you are diagnosing pregnancy in a woman, you're detecting an elevated level of a certain hormone.

[00:12:31] Speaker 04:
That's the way the claims are drafted for diagnosing pregnancy in a woman elevated

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level of a particular hormone.

[00:12:37] Speaker 04:
Why isn't that exactly on all fours with this?

[00:12:40] Speaker 04:
You're not technically diagnosing pregnancy.

[00:12:42] Speaker 04:
In fact, the claims don't say that.

[00:12:43] Speaker 04:
The claims say diagnosing an elevated level of, I don't remember the name of the hormone, but a particular hormone.

[00:12:48] Speaker 04:
Why isn't that on all fours with this?

[00:12:50] Speaker 01:
Because in that circumstance, if you're using the hormone to diagnose the condition that exists, here the condition already exists.

[00:12:59] Speaker 01:
Every patient that's tested already has CVD.

[00:13:03] Speaker 04:
And every patient that's pregnant already has an elevated level of hormone.

[00:13:07] Speaker 01:
Yes, but the purpose of those claims is to figure out if the patient is pregnant or not.

[00:13:11] Speaker 01:
The purpose here is not to determine if you have CVD or not.

[00:13:15] Speaker 01:
It's to determine what the level is so the physician can decide the treatment.

[00:13:19] Speaker 01:
It's fundamentally different.

[00:13:20] Speaker 01:
And I really urge the court, if you look at example 29 in the PTO guidelines, the differences between claim one and claim two

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very clear.

[00:13:30] Speaker 01:
If it doesn't have the diagnosis or prognosis element, it's not directed to a patent-ineligible subject.

[00:13:37] Speaker 02:
I want to get a quick housekeeping question in.

[00:13:40] Speaker 02:
Yeah.

[00:13:42] Speaker 02:
True Health argues that CCF never proposed a specific or concrete claim construction.

[00:13:48] Speaker 02:
In the gray brief at Node 8, you say you did.

[00:13:53] Speaker 02:
But when I look to what you cited, I don't have specifics.

[00:13:57] Speaker 02:
What claim terms did you identify as needing construction, and where in the record?

[00:14:02] Speaker 01:
Right.

[00:14:03] Speaker 01:
So we identified a number of terms as needing construction, and in pages 35 and 36 of our blue brief, and I believe in the footnote there, we explained some of the terms that do.

[00:14:13] Speaker 01:
Okay.

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And they were also raised to the trial court in the briefs in the trial court.

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And the point there was we never got to claim construction.

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So we didn't propose an elaborate construction of the claims.

[00:14:26] Speaker 01:
We said these claims require construction in the context of this case to understand what a skilled artisan would understand.

[00:14:33] Speaker 01:
And the district court never got to that point.

[00:14:35] Speaker 00:
You wanted to save some time, and it's almost exhausted.

[00:14:39] Speaker 00:
I'll give you two minutes for a bottle.

[00:14:40] Speaker 02:
Thank you, Your Honor.

[00:14:43] Speaker 02:
Thanks for the answer.

[00:14:44] Speaker 02:
I'm sorry for eating your time, but I wanted to know.

[00:14:46] Speaker 00:
Thank you.

[00:14:48] Speaker 00:
Mr. Matric.

[00:14:49] Speaker 02:
May I please the court?

[00:14:54] Speaker 03:
I think it would be appropriate to pick up on Your Honor's question regarding the claim construction issue and whether the claim construction issue was raised.

[00:15:01] Speaker 03:
There were claims cited in broad statements made that claim construction was required, no different than the first appeal in this case.

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And in this Court's decision in the first appeal, it was made very clear that simply invoking claim construction or identifying terms without proposing a claim construction and explaining how it may lead to a different conclusion is insufficient.

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Here, on this record, the claims aren't even identified.

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It's boiled down to the basic proposition that as long as the terms claim construction or expert testimony are interjected at the district court stage.

[00:15:33] Speaker 02:
I want to ask you some Skidmore questions.

[00:15:34] Speaker 02:
Yes.

[00:15:36] Speaker 02:
In the red brief at 42, you say that any failure by the district court to recognize that the guidelines may warrant Skidmore different is harmless error.

[00:15:48] Speaker 02:
Is it your position that the eligible

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eligibility guidelines are not afforded Skidmore difference, or are you only arguing that example 29 lacks persuasive force?

[00:16:00] Speaker 03:
Both, and I don't think the result changes.

[00:16:03] Speaker 03:
I think whether they're, you know, in this instance, it's not statutory construction of an ambiguous statute.

[00:16:10] Speaker 02:
Well, whether it changes or not, I want to get to whether we, the Court aired below by not providing it.

[00:16:18] Speaker 02:
If you're, and you say,

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both, so it seems to me you're challenging Skidmore.

[00:16:23] Speaker 03:
No, no.

[00:16:25] Speaker 03:
Given that the statute, given that the exclusions, the exceptions, abstract idea, natural law, natural phenomenon are not in the statute, they're judicial creations, given that the two-part test for determining patent eligibility is based on Supreme Court precedent, it doesn't neatly fit into the Skidmore dynamic where the idea behind Skidmore is that when an agency is charged with administering a statutory regime and the statute is

[00:16:50] Speaker 03:
ambiguous their construction of the statute.

[00:16:53] Speaker 02:
What about Carnegie Mellon versus Hoffman LaRoche?

[00:16:58] Speaker 02:
We didn't cite Skidmore, but we held similar guidelines were persuasive authority.

[00:17:03] Speaker 03:
Yeah, this court has treated the guidelines by providing notice and reviewing the examples, making a determination in some instances that the examples are analogous and some instances they are not.

[00:17:15] Speaker 03:
This court has addressed the guidelines in the context of 101 utility, patent eligibility,

[00:17:19] Speaker 03:
and 112 written description.

[00:17:21] Speaker 03:
That's precisely what the district court did here.

[00:17:23] Speaker 03:
The allegation has been made that the district court ignored the guidelines or ignored the prosecution history.

[00:17:29] Speaker 03:
But in the court's order, it specifically discussed the examples that are part of the guideline.

[00:17:35] Speaker 03:
It states in the footnote where it describes where it cites Christianson and cites Skidmore that it disagreed with the patent examiner's analogy.

[00:17:43] Speaker 03:
And then it goes on to explain why it disagreed with the analogy.

[00:17:46] Speaker 03:
The district court rightly found that example one

[00:17:49] Speaker 03:
or example 29, claim one was inapt.

[00:17:51] Speaker 03:
That claim is directed to simply detecting a protein in a sample.

[00:17:57] Speaker 03:
Now these claims, there was an attempt to draft the claims here in light of the first case, Cleveland Clinic One, on example one, but they couldn't get there because in the specification there are admissions that there were techniques already available and used in the field to detect MVO plasma or activity in blood

[00:18:18] Speaker 03:
So they couldn't draft the claims directly on the example.

[00:18:21] Speaker 03:
These claims are analogous.

[00:18:24] Speaker 03:
These claims are methods to detect elevated levels in the blood of patients having atherosclerotic cardiovascular disease.

[00:18:32] Speaker 03:
They're attempts to observe, or they are claims to observe, the natural law.

[00:18:36] Speaker 03:
Whether they're nominally drafted as laboratory methods, which we disagree with, laboratory methods as we understand them, as was described in this court's opinion in the first appeal, are

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spectrophotometric testing or immunoassay testing using antibodies.

[00:18:52] Speaker 03:
What's the natural law?

[00:18:53] Speaker 03:
The correlation between elevated MPO levels in the bloodstream and cardiovascular disease.

[00:19:00] Speaker 02:
So whenever there's CVD, there's always elevated MPO?

[00:19:05] Speaker 02:
Because that seems to fly in the face of the conventional wisdom.

[00:19:10] Speaker 03:
It may be that conventional wisdom taught away from the discovery.

[00:19:15] Speaker 03:
But that the discovery of the natural law is that elevated MPO levels in the bloodstream, free circulating in the bloodstream correlate the CBD.

[00:19:23] Speaker 03:
There's been some discussion here about the prior art teaching away.

[00:19:26] Speaker 02:
Well, there were attempts to look at other- Because you're directly contradicting opposing counsel and my memory, do they always correlate with

[00:19:41] Speaker 03:
CVD?

[00:19:41] Speaker 03:
There were attempts looking at other bodily samples, measuring in tissue, measuring indirectly intracellular levels where the prior art may have suggested that the correlation was less clear.

[00:19:53] Speaker 03:
There are references in the briefs that the patentees were the first to see the correlation.

[00:19:58] Speaker 03:
Well, what they did was they started with certain bodily samples and tests and through an iterative process they arrived at, if we focus on free circulating MPO in blood and we measure mass or activity,

[00:20:10] Speaker 03:
That's the correlation.

[00:20:11] Speaker 03:
That's the correlation that's discovered.

[00:20:12] Speaker 03:
That's how you see the correlation.

[00:20:14] Speaker 03:
That's the same iterative process that's involved trial and error in any scientific discovery.

[00:20:19] Speaker 03:
It's the same arguments that were rejected in Myriad where the patentees attempted to argue in the iterative scientific discovery process into the claims when it's not part of the analysis.

[00:20:31] Speaker 02:
So correct me if I'm wrong, but what you're saying is it's always elevated in

[00:20:38] Speaker 02:
persons with cardiovascular disease just wasn't determined.

[00:20:44] Speaker 03:
It had not been discovered that patients with cardiovascular disease had elevated pre-circulating MPO levels.

[00:20:50] Speaker 03:
I haven't seen scientific studies that indicate it's always or with the degree of cardio, but as stated in the specification, the discovery was that patients with coronary artery disease, CADs, cardiovascular disease had elevated MPO levels in their blood.

[00:21:07] Speaker 03:
compared to apparently healthy patients, normal patients.

[00:21:10] Speaker 00:
Your biggest problem, I think, is example 29.

[00:21:14] Speaker 03:
I would disagree, Your Honor.

[00:21:18] Speaker 00:
I think that the district court... If detecting, comprising, obtaining a sample and detecting whether there's a binding there, that's these claims, right?

[00:21:33] Speaker 03:
No, I would disagree, Your Honor.

[00:21:35] Speaker 03:
I believe that these claims are

[00:21:37] Speaker 03:
directed to detecting the natural law.

[00:21:40] Speaker 03:
Example one, 29 claim one is a basic laboratory technique.

[00:21:45] Speaker 03:
You're detecting a protein in a bodily sample.

[00:21:48] Speaker 03:
That's where it begins, that's where it ends.

[00:21:50] Speaker 03:
Those types of claims are directed to the underlying assay.

[00:21:53] Speaker 03:
They may be sufficiently inventive to pass through the 101 analysis at step one.

[00:22:01] Speaker 03:
Again, based on what existed in the art, those types of basic laboratory techniques could not be claimed.

[00:22:07] Speaker 03:
What was claimed instead is a method to observe the natural law.

[00:22:11] Speaker 03:
Upon physical inspection, practitioners can't predict or determine if a patient with cardiovascular disease has elevated levels.

[00:22:18] Speaker 03:
So these are the basic antecedent steps that are necessary to observe the natural law.

[00:22:22] Speaker 03:
And this court has routinely stated that claims which merely recite, observe, or state a natural law without an application are

[00:22:31] Speaker 03:
fail to satisfy the 101 test.

[00:22:33] Speaker 03:
That's what we have here.

[00:22:35] Speaker 03:
If the claims were limited to detecting MPO in the blood, they may be analogous to the example.

[00:22:42] Speaker 03:
But the district court was right in distinguishing the example from these claims.

[00:22:47] Speaker 03:
The district court owed no, was not bound by the examiner's determination.

[00:22:54] Speaker 03:
Deference to the patent office's analysis of the examples is captured by the presumption of validity under section 282.

[00:23:00] Speaker 03:
And again, the district court treated the guidelines as this court has treated the guidelines, gave them notice, analyzed the PTO's interpretation, analyzed the examiner's analysis, and found it was unpersuasive and an inappropriate analogy.

[00:23:20] Speaker 03:
And the guidelines themselves state

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And this is at appendix 1151 and 1153.

[00:23:28] Speaker 03:
These are illustrative.

[00:23:31] Speaker 03:
They are general examples that they are specific to the facts of those examples and that other claims need to be interpreted independently.

[00:23:40] Speaker 03:
And that's what happened here.

[00:23:43] Speaker 00:
So you're not challenging the lawfulness of example 29 as a guideline to interpret

[00:23:53] Speaker 00:
Section 101 under Supreme Court precedent.

[00:23:57] Speaker 03:
I think that there are serious questions or there are questions about how much deference to give the guidelines, given that the case law is being developed by the Supreme Court and this Court.

[00:24:08] Speaker 03:
The most recent guidelines published by the PTO, which I believe came out this week, make very clear that the guidelines are PQ interpretations of

[00:24:17] Speaker 03:
Supreme Court and Federal Circuit precedent.

[00:24:20] Speaker 03:
They're following the case law development.

[00:24:22] Speaker 03:
So I think that puts the guidelines in sort of a gray area, how much deference should be afforded them, given that ultimately this is a court created doctrine and the courts are interpreted how to apply 101.

[00:24:35] Speaker 03:
But nonetheless, in this case, the court went through the necessary process of taking notice of the guidelines, analyzing the guidelines and distinguishing them and explaining why they're distinguishable.

[00:24:47] Speaker 03:
In the end, at step two, the argument really boils down to, well, all the underlying techniques may be conventional, routine, and well-known.

[00:24:57] Speaker 04:
Are all proteins detectable in the same way?

[00:25:02] Speaker 03:
No, Your Honor.

[00:25:03] Speaker 04:
And in example 29 of the PTO's guidance, isn't it clear that what has been discovered there is a method of detecting a newly discovered protein?

[00:25:15] Speaker 04:
So this is a method of identifying a protein.

[00:25:18] Speaker 04:
Isn't it true that in example 29 of the PTO guidelines, that protein was not known according to the example?

[00:25:23] Speaker 04:
At least I thought that way.

[00:25:24] Speaker 03:
According to the example, according to the limited information.

[00:25:26] Speaker 04:
That's not true here, is it?

[00:25:27] Speaker 03:
No, it is not.

[00:25:28] Speaker 03:
In this case.

[00:25:28] Speaker 03:
And there were already techniques available.

[00:25:30] Speaker 04:
So is it possible that what was being claimed, or what the PTO was saying was eligible in that instance, is when you discover a new protein, if there are many different ways of detecting proteins, and not all of them work and such,

[00:25:41] Speaker 04:
You can figure out that it is possible that it could be eligible method of detecting this protein, which wasn't known before and thus we aren't sure how you could detect it.

[00:25:51] Speaker 04:
So it's the method of detecting that protein because the protein was unknown and there are many different methods, some may work, some may not.

[00:25:59] Speaker 04:
Here we have a known protein and a known method, right?

[00:26:06] Speaker 03:
That's why it's not analogous to claim one.

[00:26:08] Speaker 04:
I'm sorry, I didn't hear you say that before.

[00:26:10] Speaker 04:
That's why I just wanted to ask you whether you agreed with that.

[00:26:13] Speaker 04:
Is that a possibly a basis for distinguishing, even if the PTO is right about example 29, for example, is that a potential basis for distinguishing this case for eligibility purposes from that one?

[00:26:26] Speaker 03:
I think it is.

[00:26:27] Speaker 03:
I think part of the problem with the example is that there's not enough information.

[00:26:30] Speaker 03:
I mean, the step one

[00:26:33] Speaker 04:
Do you think VTO's example number 29 on its face is wrong?

[00:26:37] Speaker 04:
And if we had exactly that case, we should not find, as they suggest, eligibility?

[00:26:44] Speaker 03:
I think that if the only purpose of measuring JUL was its ability to predict gelitis, and there were statements in the specification, for example, that said our contribution to the art, our advancement over what was done previously was this discovery,

[00:26:59] Speaker 03:
and now we're reciting the lab method, that taking all of that into consideration, Claim 1 itself could be problematic under other facts.

[00:27:08] Speaker 03:
Here, as interpreted, it's simply a laboratory assay or method to detect a protein.

[00:27:14] Speaker 03:
It's not interjecting the natural law.

[00:27:16] Speaker 03:
Now, for example, if the claim had been written, a method to detect patients having ulitis by measuring JLO in the bloodstream,

[00:27:29] Speaker 03:
pretty close to what we have here.

[00:27:30] Speaker 03:
I mean, then you're using the detection to observe the natural law.

[00:27:35] Speaker 03:
The natural law is the focus of the claim.

[00:27:37] Speaker 03:
It's not the underlying laboratory technique.

[00:27:39] Speaker 03:
It's we want to observe the natural law.

[00:27:41] Speaker 03:
These are the necessary steps we need to get there.

[00:27:44] Speaker 03:
And at that point, they're focused on the natural law.

[00:27:47] Speaker 03:
And there has to be some application, some integration of the natural law into a method of producing things or into a method of treatment or a novel assay.

[00:27:58] Speaker 03:
a improved anti-MPL antibody that detects or binds to MPL and plasma with greater affinity and detects with greater specificity.

[00:28:09] Speaker 03:
Those are all the potential types of claims that might have been drafted once the inventors discovered the natural correlation here, the natural law, but they stopped at, here are the antecedent steps that need to be taken just to observe it.

[00:28:25] Speaker 03:
And then you stop.

[00:28:27] Speaker 03:
The product of the claims is merely observing the natural law.

[00:28:30] Speaker 03:
And so when we get to step two, the district court accepted the argument that this was the first time these well-known techniques had been applied to this natural law.

[00:28:43] Speaker 03:
But at step two, the natural law has to be divorced from the analysis.

[00:28:46] Speaker 03:
It has to be treated as part of the prior art.

[00:28:48] Speaker 03:
And that argument was rejected by this court, Ariosa.

[00:28:52] Speaker 03:
And it was rejected by this court in genetic technologies.

[00:28:54] Speaker 02:
Do you disagree with your opposing counsel that the changing sample size impacts the discovery?

[00:29:04] Speaker 03:
Or the impacts of the discovery?

[00:29:05] Speaker 03:
No.

[00:29:05] Speaker 03:
This court addressed the statistical techniques cited in the specification and used in the parent patent and used here in its prior decision.

[00:29:13] Speaker 03:
The sampling techniques, the statistical techniques used were conventional.

[00:29:19] Speaker 03:
And to the extent there are arguments being made about a study needs to be sufficiently powered to provide medically relevant data, I mean, that's not part of the claims.

[00:29:29] Speaker 03:
And the underlying techniques they use that this Court previously found, the same techniques claim here are conventional.

[00:29:39] Speaker 00:
Thank you.

[00:29:40] Speaker 00:
There's nothing further than a rebuttal from Mr. Rosenberg.

[00:29:49] Speaker 01:
A few brief points.

[00:29:50] Speaker 01:
First of all, in response to Judge Moore's question, I think the question about whether the protein is new conflates the step one and step two analysis of ALICE.

[00:30:00] Speaker 01:
What the PTO is saying in the guidelines is, is this directed at step one to a natural phenomenon?

[00:30:07] Speaker 01:
And if it's a lab method to detect a protein, it's not.

[00:30:10] Speaker 01:
Whether the protein's new or novel is a step two analysis.

[00:30:13] Speaker 01:
And at step two here, I want to emphasize

[00:30:16] Speaker 01:
The prior art absolutely taught away from this method of analysis.

[00:30:21] Speaker 01:
It taught away from using these lab methods.

[00:30:23] Speaker 01:
It taught away from measuring MPO and blood plasma as being medically significant.

[00:30:29] Speaker 01:
And the district court entirely ignored that.

[00:30:33] Speaker 01:
That leads us into the Skidmore point.

[00:30:35] Speaker 01:
I agree, Judge Lurie, that example 29 is critical here, both at step one and at step two.

[00:30:41] Speaker 01:
And while my opponent is right that the district court did discuss a little bit the guidelines with respect to step one, there was no discussion of what the PTO did with the guidelines or the prior art at step two.

[00:30:52] Speaker 01:
None in the district court's decision.

[00:30:54] Speaker 01:
That's reversible error.

[00:30:56] Speaker 01:
Third, when you actually look at the state of the art, I want to emphasize the specification and if there were factual development, the facts would have shown that there were years and years of research

[00:31:08] Speaker 01:
by the leaders in the field in MPO research before they ever got to these methods.

[00:31:13] Speaker 01:
They tried MPXI for years.

[00:31:15] Speaker 01:
They looked at the prior art references that had looked at blood plasma and found that MPO could not be measured in any way that was significant.

[00:31:23] Speaker 01:
I would emphasize to the court, I'm not aware of any life sciences case where this court has upheld a section 101 dismissal in the pleadings where the prior art taught away from claimed laboratory methods.

[00:31:36] Speaker 01:
And finally, I would just like to mention the PTO guidelines that were issued this week for notice and comment reaffirm their view that their prior analysis in the life sciences area is valid.

[00:31:47] Speaker 01:
Example 29 has not been changed at all since it was promulgated by the PTO.

[00:31:54] Speaker 00:
Thank you very much.