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We have six cases on the calendar this morning.

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Three patent cases, one from the district court and two from the Patent Office.

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Two cases from the Court of Federal Claims and one from the Merit Systems Protection Board.

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The last one and one of the claims cases are being submitted on the briefs and will not be argued.

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Our first case is

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Cleveland Clinic versus True Health Diagnostics, 2016-1766.

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Mr. Rosenberg.

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May you please report.

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The district court below failed to undertake several necessary steps in this case, and the legal analysis it did perform was erroneous.

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This court should reverse for three independent reasons.

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First, in this case, it was necessary to undertake claim construction, to look at the claims individually, to look at factual development, and to fully consider the prosecution history.

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And the court's failure to do that below was reversible error.

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Second.

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But look, we review decisions, not opinions.

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And when I look at, say, claim 11 of 552, it's a method of assessing the risk of cardiovascular disease comprising comparing, which is a mental step, comparing the level of myeloperoxidase with control subjects wherein this is a result, wherein the levels of myeloperoxidase

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relative to comparable body sample samples are indicative.

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I mean, how is that different from Mayo?

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So it's different from Mayo in a number of respects.

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First of all, in Mayo, the discovery at issue was really not a discovery.

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The idea of using these thio-curing drugs for treating antiimmune disorders was known in the art.

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Everyone in the art knew that if you gave too little of the drug,

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it was going to be ineffective, and too much of the drug you were going to have side effects.

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So we look at claims, rather than what's behind them, whether one was a discovery and one was not.

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Right.

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If there was a discovery here, then perhaps it could have been claimed as a new method of determining something involving physical steps, but it wasn't.

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But it is, because the determining facets here

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include using conventional methods for an entirely new purpose.

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Nobody in the art knew that you could use any of the techniques claimed, and many of them are specifically claimed in the dependent claims.

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No one knew you could use an immunological technique like an ELISA, flow cytometry, or mononuclear antibodies to measure MPO mass activity or oxidation products in the blood for the purpose of diagnosing CVD.

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This is very much like the rapid litigation case.

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In that case, there was a discovery that liver cells could be repeatedly frozen.

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And the inventors applied that by using conventional freezing techniques, but doing it in a new way to preserve the liver cells.

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That is exactly what we have here, a new discovery that MPO in the blood can be used for the purpose of diagnosing CVD and taking laboratory methods that nobody were able to use for this purpose.

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Let me start with step one.

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You argue instances where you say CCS stated that claims are directed to that eligible subject matter.

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Correct.

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But there's no reasoning accompanying those assertions.

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And we've stated that skeletal or undeveloped arguments are waived on appeal.

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So show me in the record where CCS made an argument that was more than skeletal or undeveloped.

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So in the brief below, if you look at appendix 3349 to 50, in the introduction to the brief below, the lawyers, it's appendix 3349 to 50.

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And let me just read you the key passage.

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It says, the MPO testing patents

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claim a non-routine way of measuring and using MPO to achieve a new and useful result.

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Contrary to True Health's arguments, these patents are not merely a discovery of a law of nature.

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The USPTO found on multiple occasions that the MPO testing patents innovatively cover non-routine techniques for seeing, measuring, and applying MPO.

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The claims of the patents combine determining, comparing, and measuring.

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Levels of MPO activity, MPO mass, or both

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with the use of results and predetermined values to predict risk of cardiovascular disease.

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This was a marked improvement over the then state-of-the-art methods measuring MPO.

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Simply put, Cleveland Clinic invented a specific way to see MPO and a specific way to use the new result.

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None of this existed naturally, and no one had invented it before the Cleveland Clinic.

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While it isn't labeled step one, that is plainly a step one argument.

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And as this court has repeatedly said,

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Step one and step two, particularly before the most recent cases from this court, like Rapid Litigation and McGraw, were often conflated.

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There was very limited proceedings in the district court below.

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There was a single brief that was 30 pages long.

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And the lawyers below did, in fact, say they were arguing step one and step two.

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But in the introduction, they explained the reasoning for the step one argument.

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This is not.

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Counsel, when I look at the claims,

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And I ask myself, what are the claims directed to?

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I just can't get away from the fact that it seems to me that the claims are directed towards the use of MPO in human samples in order to predict cardiovascular disease.

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You're using MPO to predict cardiovascular.

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And you're saying that, well, what's novel here is that we get a better result.

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No.

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What's novel here is that nobody knew to even do this beforehand.

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and they didn't know how to do it.

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The prior Terlitz-Sky method, which was the only thing that ever looked at MPO in the blood for purposes of CVD, twadaway.

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Terlitz-Sky said if you had heart attacks, your MPO levels would be lower than healthy subjects, because they used a different method for analyzing MPO.

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So let's assume that being able to see the MPO is a groundbreaking discovery.

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How does this get you past ARIOSA?

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It gets us past it because it's not just being able to see it.

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It's using techniques that were not known in the art for doing it.

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In Ariosa... You're taking me to step two.

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No, okay.

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In step one, I'm sorry.

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Yeah, what are the claims directed?

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Because it's directed to an application.

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It's like rapid litigation.

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It's not directed to simply observing the natural phenomenon.

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It's directed to a new method, a new laboratory method.

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That's what using these techniques, the ELISA, the flow cytometry, the mononuclear antibody tests,

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These are all tests defined in the specification and in the dependent claims that the district court never looked at that specifically say these are techniques you can use to do this.

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That's why it's like rapid litigation.

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And then you add to that, Judge Reyna, the whole comparing methodology.

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I would submit there is no case that this court or the Supreme Court has ever said fails 101 with anything like the comparing methodology you have here.

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This was a methodology that had to be fully derived using.

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Isn't comparing a mental step?

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if all you do is look at A and B. But here, you have to develop through experimentation the control methodology.

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Here, you have to, I mean, the inventors looked at thousands upon thousands of samples to initially determine what could be a comparison level.

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And then as the specification teaches, they dynamically adjust those levels when new data is obtained.

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It's not just looking at DNA strand number one and DNA strand number two.

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It's a completely new method.

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One critical point here.

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Hang on a minute.

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Back about four pages in the transcript, you seemed to be saying that the district court erred by not addressing certain claims.

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Correct.

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So in effect, that it erred by treating certain claims as representative.

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Correct.

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And you make that argument and you're blue-braided.

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But CCF only made a general objection to the selection of representative claims.

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It basically said the claims, it said the claims are not representative, and you had to look at the dependent claims, and then it used a couple of for-examples, and it used the claim that specifically talks about an immunological technique.

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How are the ones that aren't addressed not waived on the claim?

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They're not waived because it was a general objection to using representative claims, and it says each dependent claim has to be reviewed.

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And then it just said a for example.

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I mean, part of the problem was, and this is what I was getting at, there's only a single life sciences case where this court or the Supreme Court has ever upheld a dismissal on a 12b6.

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And that was the Muriel case.

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And in Muriel, there was a single claim at issue that the parties had stipulated to and no claim construction dispute whatsoever.

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Here below, we argued, number one, these claims were not representative.

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You had to look at the dependent claims.

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and that there were several critical claim terms that had to be construed, including comparing, determining, and predetermined value.

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And what I was getting at with the control group, that is all in the definition and the specification for predetermined value.

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That is a critical part of this invention that is entirely human made.

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Human beings have to figure out how to do the methods for this control group.

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They chose statistical methods that are set forth in the specification

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They use these statistical methods in evaluating thousands of samples in years of research.

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That is entirely human ingenuity.

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That is all in the patent under predetermined value description.

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And in the examples, for example, example one, in the 552 patent, none of that was examined by the district court.

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And all of that was implied by the arguments that were made below.

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You have to look at the claims individually.

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You have to construe the claims.

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Where in the record did

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CCF proposed a construction that the district court did not adopt?

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They did not propose specific constructions below.

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And I think it is very difficult to force a party at the pleading stage to develop an entire claim construction.

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That's why we do markman hearings.

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That's why we have a claim construction process.

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What they did do was identify the terms that needed construing and explain in the brief, admittedly not the greatest detail because of the limited scope of the briefing, but they did explain

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that, for example, comparing includes this control group analysis.

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And if the court had- Did you propose any constructions?

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We did not propose specific constructions below.

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No.

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And I think that's the problem with doing this.

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Doesn't that leave the court at its discretion to pick which claim is representative and to proceed with the 101 analysis?

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I don't think so, Judge Raina, because they specifically objected to both of those.

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They specifically said below, you can't look at the claims as representative.

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because the dependent claims have new inventions, different inventions.

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And they said, these are the terms that require construction.

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And they put enough meat in the bone in that brief to explain why it was significant.

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What requires construction?

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These claims are in plain English.

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Comparing, wherein, leading to describing results.

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Well, so if you look at the predetermined value portion of these patents, it goes through in laborious detail the statistical methods

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that are being used.

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I would direct the court's attention just for a minute.

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If you turn to the 581 patent, which is on Appendix 86, if you just take a look at Claim 5 of that patent, and I'm sorry to turn the court's attention to this, but if you look at this, you see both determining and comparing, but you have all of this additional detail

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and a list of these several oxidation products of MPO that can be measured and accounted for, which, by the way, no one in the prior art even ever thought about looking at.

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This is stuff.

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This needs to be construed.

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I mean, you're talking about determining, and you've got this list of oxidation products, and you have to figure out how those things dovetail.

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That's why construction was so important.

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You, Judge Luriet, may be plain English.

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Everybody else, not so much.

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So I think it has to be.

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It has to be reviewed, and it has to be looked at carefully.

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I say I'm into my rebuttal time.

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Just one final point.

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Independently, the 260 inducement and contributory negligence claim should not have been dismissed.

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And certainly, leave to amend should have been freely given.

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The court gave no reason not for leave to amend.

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And in the opposition to the motion to dismiss, the lawyers below specifically said we've got infringement contentions.

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that we're attaching.

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And if you have any problems with the complaint, let us amend the complaint to add the infringement contentions.

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Judge Rainer has a question.

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Sir.

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Just very quickly, Counselor.

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I'd like for you to address step two of the Ellis inquiry, especially because it seems to me that what we're dealing with here are well-known existing conventional steps.

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So if you get to step two,

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Number one, you've got the ordered combination of new steps.

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You've got the detecting and measuring methods that I talked about before.

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Those are conventional.

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The detecting and the measuring are conventional.

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But not for this purpose.

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It's just like rapid litigation.

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They were used for other purposes.

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They were not used for this purpose.

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No one in New York ever thought to use them for this purpose.

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But then you add that whole comparing methodology.

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That's not conventional.

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That's a derived comparison, analysis, and critically judgment.

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But if you're using, let's say, conventional steps for a conventional purpose, how can you say that they're being used for a new purpose?

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Step for detection or step for detection?

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Right, but nobody thought to detect MPO for the purpose of CVD.

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That may be true, but the steps you're talking about are conventional.

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But they're adapted.

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I mean, all the steps almost involve something different.

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They're detecting something different.

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Blood, serum, organisms.

[00:15:20] Speaker 04:
Yeah, but those specific tests, whether it's the ELISA, whether it's flow cytometry, they were used for other purposes.

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They were not used for these purposes.

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And they were adapted.

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In the specification, they tell you how to use these tests adapted for this particular purpose.

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And then you add the comparing methodology, the protocol, which requires you to use these methods to derive the values you use as the control.

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If you use the Terlett-Skyler method to derive the control values, it will be completely inaccurate.

[00:15:49] Speaker 04:
Thank you, Your Honor.

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Counsel, we'll give you two minutes for rebuttal time.

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I appreciate it.

[00:15:55] Speaker 03:
Thank you.

[00:15:55] Speaker 00:
Mr. Machwick.

[00:15:57] Speaker 03:
Good morning, Your Honor.

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Just speak.

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You addressed rapid litigation in footnote two of your brief.

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But speak to that first.

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Yes, Your Honor.

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Rapid litigation was an application of a natural phenomenon.

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And that's the important distinction.

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Rapid litigation was decided at step one.

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What the court said was not every claim that recites or includes a natural phenomenon is absolutely ineligible.

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But importantly, there must be a transformation of the natural law into

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that ineligible subject matter.

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Now, the court gave two examples.

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There can be a new assay, a new measurement technique employed that can be in the event of step, or there can be a treatment, a method of treatment, an application of the natural phenomenon.

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And that is where the court landed with respect to cells threat.

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In step one, it was not merely reciting that primary liver cells can be frozen and thawed multiple cycles.

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It was an application to create a preparation of cells that can be reused.

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With respect to step two, the court did go on to analyze step two.

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And what the court said was the conventional technique at the time was applying a single freeze-thaw cycle.

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So the techniques were standard, but they were only used once.

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And with respect to self-derest, those techniques were used in two cycles, twice.

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And that was different than the conventional techniques.

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Those facts, that analysis does not apply to this case.

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The claims here, the inventive contribution, was the discovery of natural phenomenon.

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And whether it was an important discovery, it was the discovery of a correlation between a blood enzyme, MPO, and the risk of having or developing cardiovascular disease.

[00:17:40] Speaker 01:
Do you believe Arioso applies in this particular case?

[00:17:43] Speaker 02:
I believe Arioso applies to me.

[00:17:45] Speaker 01:
OK, explain why.

[00:17:48] Speaker 02:
Mr. Rosenberger, at the end of his discussion, brought up step two and the position that

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Prior to this discovery, these techniques had never been used previously to measure NPO in blood and to predict atherosclerotic cardiovascular disease.

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As Ariosa showed, step two removes the discovery from the analysis.

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And so the question at step two is whether the techniques apart from the discovery are against the conventional wisdom or non-routine.

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Here the techniques, using immunological techniques or paradox

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Assays to measure activity were conventional and known.

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Creating control groups, which is not a claim limitation.

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No claim of the MPO testing patents requires creating.

[00:18:35] Speaker 01:
Your opponent says it may have been conventional, well, no, but they hadn't been used for the purposes asserted under step one.

[00:18:44] Speaker 02:
They had not been used for purposes of that discovery.

[00:18:47] Speaker 02:
That was the same issue.

[00:18:47] Speaker 01:
For seeing, yeah, the MPO.

[00:18:50] Speaker 02:
The technologies described in the specification.

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For example, measuring MPO by immunological technique had been used for MPO.

[00:19:00] Speaker 02:
And the inventors acknowledged that in the specification at the 552 patent, column 9, lines 30 through 33, where they say there were commercial kits available to quantify MPO in the blood.

[00:19:11] Speaker 01:
I guess I'm asking more just from a legal perspective.

[00:19:15] Speaker 01:
If we determine that steps or methods are conventional, well known,

[00:19:21] Speaker 01:
Does the fact that they're used in a different way, like step one, for the detection to see the MPO in this case, does that mean that they're no longer conventional or well-known, that they pass step two?

[00:19:37] Speaker 02:
No, it does not, your honor.

[00:19:38] Speaker 02:
Consistent with this court's decisions in Ariosa, in genetic technologies, step two looks at the detecting

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the comparing steps apart from the natural correlation, apart from the discovery.

[00:19:51] Speaker 02:
Those techniques were conventional.

[00:19:53] Speaker 01:
Well, still do we say, well, OK, you did make it past step one.

[00:19:57] Speaker 01:
So what can you tell me now about the invention that's innovative, that's different, the inventive concept?

[00:20:04] Speaker 01:
So it seems to me that there could be a time when conventional and well-known steps are used in a way that is innovative.

[00:20:14] Speaker 01:
Yes, yes.

[00:20:14] Speaker 01:
Yes.

[00:20:16] Speaker 02:
And I think CellsDirect was an example of that.

[00:20:17] Speaker 02:
What the court said in CellsDirect in step two was, while the individual... Well, why isn't it in this case?

[00:20:23] Speaker 02:
Because the techniques are being applied as they were applied to any other biomarker.

[00:20:28] Speaker 02:
The inventors, for example, cited to and incorporated a prior art patent looking at C-reactive protein into the specification of the 552 patent.

[00:20:37] Speaker 02:
It applied the same technique.

[00:20:38] Speaker 02:
C-reactive protein was a marker of inflammation of the arterial wall.

[00:20:43] Speaker 02:
Elevated levels were used to predict the risk of cardiovascular disease.

[00:20:48] Speaker 02:
The framework of the claims are the same.

[00:20:51] Speaker 00:
Well, there have been a patentable invention here, if it had been claimed differently, such as a method of determining the existence of cardiovascular disease by carrying out a certain procedure to determine the myeloperoxidase level.

[00:21:12] Speaker 02:
I think there could have been if the steps to detect MPO were unconventional.

[00:21:20] Speaker 03:
So supposing I determine that blue eyes are a predictor and that the intensity of blueness is in fact that predictor and there's a standard intensity of blueness chart and I simply say take a look and you'll be able to determine.

[00:21:42] Speaker 03:
Patentable or not?

[00:21:44] Speaker 02:
In light of Perkin-Elmer, Your Honor, I do not believe it's patentable.

[00:21:46] Speaker 02:
Perkin-Elmer was looking at markers of genetic defects, comparing those to standard ranges or standard values.

[00:21:54] Speaker 02:
And that comparison was ineligible for her.

[00:21:57] Speaker 03:
What could I do with that chart that would make it patentable?

[00:22:01] Speaker 02:
Claussen gives an example, another case decided by this court, where there were immunization schedules.

[00:22:07] Speaker 02:
And there was an application step of following a specific schedule based on what was detected.

[00:22:14] Speaker 02:
Here, there could, for example, be application steps once observing the natural phenomenon, which is all the current claims recite.

[00:22:21] Speaker 02:
Is there an application?

[00:22:23] Speaker 02:
Is there a method of treatment step added to those claims that could pass the 101 threshold, could be a transformative application?

[00:22:32] Speaker 02:
But even there, not all applications necessarily are transformative.

[00:22:36] Speaker 02:
It must transform the natural law into patent-eligible subject matter.

[00:22:39] Speaker 02:
So these claims, as this court has noted, as the Supreme Court has noted, once the inventors discovered the natural phenomenon, they were in a position to recite claims that provided an application of that natural law.

[00:22:53] Speaker 02:
But they stopped at reciting the natural law or observing the natural law.

[00:22:56] Speaker 02:
The wearing clause simply instructs artisans to observe the natural phenomenon

[00:23:01] Speaker 02:
And there's nothing left to do.

[00:23:03] Speaker 03:
So when I come up with my blueness intensity detector, I may have some combined.

[00:23:12] Speaker 02:
Combined with additional application steps, yes, Your Honor.

[00:23:15] Speaker 02:
Yeah.

[00:23:15] Speaker 02:
But the law does not say, and we have not taken the position, that again, every claim which recites or relies on in some capacity a natural phenomenon is absolutely ineligible.

[00:23:26] Speaker 02:
But just reciting the natural law isn't enough.

[00:23:29] Speaker 02:
There must be an application to transform the law into patent-eligible subject matter.

[00:23:33] Speaker 02:
And that's what was lacking here.

[00:23:34] Speaker 02:
And that's why the lower court correctly ruled.

[00:23:37] Speaker 00:
Now, method of treatment claims transform that which is treated with the treatment.

[00:23:50] Speaker 00:
But diagnostic claims,

[00:23:56] Speaker 00:
examine what is there, what exists.

[00:24:01] Speaker 00:
Is it your view that diagnostic claims can never pass muster because they are determining the existence of a natural phenomenon?

[00:24:12] Speaker 02:
No, Your Honor, but diagnostic claims that use conventional techniques to observe a correlation

[00:24:18] Speaker 02:
and do not apply that correlation or do not have.

[00:24:21] Speaker 00:
So you're saying the use of non-conventional techniques renders a diagnostic claim patent eligible?

[00:24:28] Speaker 02:
No, Your Honor.

[00:24:29] Speaker 02:
The use of non-conventional techniques.

[00:24:31] Speaker 02:
Non-conventional.

[00:24:31] Speaker 02:
Non-conventional techniques.

[00:24:33] Speaker 02:
This, Your Honor, may render diagnostic claims patent eligible.

[00:24:36] Speaker 02:
And again, in CellsDirect, this court went on to step two and identified an example of an uncommon combination

[00:24:44] Speaker 02:
So whether a combination is reversed or whether steps are performed twice when the prior art teachers only perform them once, that could be a sufficient inventive concept for a diagnostic claim to pass the 101 filter.

[00:24:57] Speaker 02:
The patent office, which understandably is not binding, provides examples in the instructions they give to examiners of using a assay that historically had been used in the veterinary sciences and applying it to human subjects or developing a new man-made

[00:25:15] Speaker 02:
antibody to detect the natural phenomenon.

[00:25:18] Speaker 02:
Those are examples too where that may provide sufficient inventive concept to allow for diagnostic claims to pass the one-on-one threshold.

[00:25:26] Speaker 00:
You mean a test used for veterinary subjects becomes patent eligible if it is used for human subjects?

[00:25:37] Speaker 02:
It could be unconventional to the extent that no one previously had used an assay.

[00:25:42] Speaker 02:
an antibody that was used, a porcine assay, in the veterinary sciences.

[00:25:45] Speaker 00:
Every human drug is tested on animals.

[00:25:48] Speaker 02:
Well, it's an example that, given the right facts, it could be an example of unconventional steps that are appended to or applied to a natural phenomenon that could pass step two of the Alice Mayo test.

[00:26:04] Speaker 02:
I'm happy to answer any additional questions that the court may have.

[00:26:08] Speaker 02:
But I thank the court for the time this morning.

[00:26:11] Speaker 00:
Thank you, Mr. Marcher.

[00:26:12] Speaker 00:
Mr. Rosenberg has two minutes.

[00:26:22] Speaker 04:
Thank you.

[00:26:23] Speaker 04:
I think that what my worthy opponent just said effectively concedes the case.

[00:26:27] Speaker 04:
He says if you use unconventional methods for a new purpose, now his example was porcine or animal, but that's exactly what you have here.

[00:26:34] Speaker 04:
You have using these methods like flow cytometry that nobody ever thought to use for MPO analysis

[00:26:41] Speaker 04:
And they applied it to a new purpose here, a new use.

[00:26:44] Speaker 04:
That's exactly what happened in the detecting steps.

[00:26:47] Speaker 04:
My opponent mentioned the C-reactive protein stuff.

[00:26:50] Speaker 04:
They didn't use techniques that were these techniques at all.

[00:26:53] Speaker 04:
They certainly didn't use flow cytometry.

[00:26:55] Speaker 04:
They didn't use mononuclear antibody analysis.

[00:26:58] Speaker 04:
He said, oh, if you use a man-made antibody, well, that's what this does in some of the claims.

[00:27:03] Speaker 04:
It uses man-made mononuclear antibodies to do the analysis.

[00:27:07] Speaker 04:
I mean, the dependent claims, that's why it's so critical.

[00:27:10] Speaker 04:
to look at these dependent claims individually.

[00:27:13] Speaker 04:
And that's what the district court didn't do.

[00:27:15] Speaker 03:
A determining step tells the doctor to determine the level of the relevant metabolites through whatever process the doctor or the lab wishes to use.

[00:27:26] Speaker 04:
Right.

[00:27:26] Speaker 04:
But then the dependent claims claim specific methods.

[00:27:30] Speaker 04:
And if you look back at the specification, they define the methods that are suitable.

[00:27:34] Speaker 04:
And so if there had been claim construction of determinant,

[00:27:37] Speaker 04:
One of the constructions, even of that broad independent claim, may have been determining by using a method such as flow cytometry, mononuclear antibody, or something similar.

[00:27:48] Speaker 04:
It would dramatically limit, it would dramatically reduce the possibilities.

[00:27:52] Speaker 04:
It wouldn't read a limitation into the claims, but it would instruct the physicians how to do it in a way that would actually work.

[00:27:58] Speaker 04:
That's why this is so different.

[00:28:00] Speaker 04:
My opponent mentioned kits, but in the specification here, there were specifically new kits that were developed

[00:28:07] Speaker 04:
that were suggested to be used by the physicians in performing this analysis.

[00:28:12] Speaker 04:
Finally, you asked about rapid litigation in Ariosa.

[00:28:16] Speaker 04:
As I said before, this case is very much like rapid litigation because it is using conventional methods for a new purpose.

[00:28:23] Speaker 04:
The freezing methods in rapid litigation were not new.

[00:28:26] Speaker 04:
They were just used for a new purpose.

[00:28:29] Speaker 00:
Thank you.

[00:28:29] Speaker 00:
Thank you, Mr. Rosenberg.

[00:28:30] Speaker 00:
Let's hopefully all have the right MPO levels.

[00:28:34] Speaker 04:
We'll be happy to provide testing services.

[00:28:37] Speaker 00:
We'll take the case under advisement.