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Our next case is CARE DX and Board of Trustees of Stanford versus Natira and Eurofins, 2022, 1027, and 1028.

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Good morning.

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Mr. Reinus.

[00:00:24] Speaker 04:
Good morning, Your Honors, and good to be here live.

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I'm representing CARE DX in Stanford University in this matter.

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I'd like to start with the error of the district court in applying step one, which resulted in the, we believe, erroneous invalidation of the three Stanford patents.

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In step one, a critical aspect of Mr. Reinus did

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Did your clients invent detecting rejection of transplant by the presence of self-free donor DNA?

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No.

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That's a natural law.

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Right.

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Well, not the detection of it.

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Detection of it.

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And that's what the claims are.

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Detection of it.

[00:01:09] Speaker 04:
No.

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Actually, the claims are the quantification.

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Every single claim has quantification as a critical element to it.

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So it's really the measuring of it.

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It's obviously implicit in

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Measuring is detection.

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So the claims don't read that way.

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Yes, they all do.

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It's not a method for measuring.

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It is.

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It is.

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Each one has the word detected.

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Well, some of them have that in the preamble.

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One doesn't have that in the preamble at all.

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But if you look at each of the claims, you'll see the 652 in step D by determining a quantity.

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If you look at the 497 patent,

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you will see in step D, determining an amount.

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And if you look at the 607 patent, there's an entire step, step F, dedicated to quantifying.

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So it's measuring.

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And the invention here, the claimed advance, is not detecting.

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In fact, others did detect it, right?

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So in fact, I think I misspoke because I didn't hear your point about detection.

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The natural law is not invented, and the patent's clear about that.

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There are references.

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throughout the prior, Zhang, Vinomalova, Baxter, Lowe, Liu, and Lowe, that all did detect the presence of cell-free DNA of the donor and could make a call, presumably, about organ rejection.

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But what's the inventive aspect here?

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Use of PCR?

[00:02:46] Speaker 04:
Well, no.

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PCR wouldn't be within the scope of the claims.

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One of the claims, one of the patents, refers to digital PCR, which was invented in 2006 time frame.

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At least that's the record we have here.

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But that's an amplification system, isn't it?

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It's an advanced amplification system that was certainly not routine at the time in terms of its application here.

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But I just want to be very clear about this, that the invention here is people were trying to measure the natural law.

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They were doing it in insufficient ways.

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Your assumption, Your Honor, you're a pro in this area, so I'm humbled.

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People in the art did not identify the measurement system that's claimed here.

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So it's well and good for us in 2022, and your honor knows this from all your work, to go back and say, OK, well, of course people would have used SNP detection through high throughput sequencing with selective amplification of more than 1,000.

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Of course, no one saying each one of those things was unknown to anybody.

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What we're saying and what I think screams out of the record is that the patent, so this isn't like someone throwing elbows with an expert declaration, the patent documents the failures for a decade to try and measure, quantify these things.

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All that prior art detects it.

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So to answer your question, we never said we'd invent a detection of it.

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It would be silly, because then we have column seven and column eight going through this.

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They detected it this way.

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These people used AHLA antigens to do it, which is another strategy someone might choose.

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The priority was littered for 10 years of people trying to do this, significant groups.

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And no one discovered this measurement method.

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It's the furthest thing from a natural law.

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It's a little hard for me to think that after looking at the patent, one wouldn't just see this.

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And the district court didn't even purport to do the analysis of the claimed advance.

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which is how I think this case got messed up.

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He never used the word claimed advance.

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Everyone agrees that that's an important part of step one and a distinguishing characteristic of step one.

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What is the advance?

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It's not the results, but the means.

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The advance is coming up with measurement methods that a decade of workers working in the field could not come up with to come up with a good way of quantifying

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the cell-free DNA.

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And what is the method here?

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Well, I mean, they're each of the claims.

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So one of them is use of SNPs with high throughput sequencing.

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I mean, that's, you know, I don't want to, you know, these are long names.

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Those aren't conventional methods?

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Absolutely not.

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High throughput sequencing was a cutting edge thing.

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And point here.

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Wait, but are you saying you invented that?

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Of course not.

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But the thing is, this is such complex technology that even today, for certain uses, different applications, high throughput sequencing is bleeding edge.

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There are thousands and probably more than thousands, tens of thousands of people working trying to figure out how can we apply it this way and that way.

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So it's the application of it.

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It's superficial to treat it as though it either exists or it's either routine or not.

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Cell-free DNA, the record is undisputed because it was an admission by Dr. Quackenbush on the other side, is non-random because it's the dead DNA outside the cell.

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It's not intact DNA.

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It's non-random.

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It's small amounts.

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It's short sequences.

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And it's in tiny amounts when you're trying to measure the DNA within the recipient's body.

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And that was imposing.

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And their own expert admits this at A273 of the record at 138 through 141.

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All of the challenges that people would see, you know, that they would perceive anyway, about trying to do cell-free DNA with these emergent techniques.

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these techniques were emerging.

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We didn't invent them, but if they're just, for example, digital PCR is three years old, that doesn't mean you know everything you can do with it.

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This is a very specific application of it.

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And if it was so obvious...

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struggling is, you haven't, like all these techniques, even if they are very new novel techniques, you're not saying you invented any of these techniques.

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That's true.

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You're saying you've taken these techniques and used them in a way to measure the presence of a natural phenomenon.

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Why isn't that the same analogy to the original invention of DNA sequencing and using it to detect the BRCA gene?

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And so certainly DNA sequencing was very novel, and there were lots of ways to use it.

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People were discovering how to use it.

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But didn't the Supreme Court say that that's just not enough?

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No, not in the bracket case.

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I mean, Mayo would be the closest analogy.

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That's the one people have used.

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You could look at Mayo.

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You could look at Athena.

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You could look at Cleveland Clinic.

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All those cases.

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And you're right.

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There is a line of authority that says...

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I have mushed together a Myriad and a Mayo in my mind.

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We all know what we're talking about.

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But that's the point.

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Even if it's a novel laboratory technique, you can get a patent on the novel laboratory technique if you're the ones that have been in it.

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But if you then take that and use that in a new way to just measure a natural phenomena or a law of nature or something, isn't the whole thrust of the Supreme Court and our precedent that that's just not eligible?

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Whether that should be changed or not is a different story, but isn't that the threat?

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No, I've vociferously agreed.

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I don't see how that could, to me that's not looking at the record.

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Here the patent documents

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that people did not see.

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We're saying, is there human invention here?

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That's got to be the inquiry at some level.

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Is there human invention in the measurement development?

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That's what you've all written in all your cases.

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And finding a measurement method that worked for this when group after group was trying to find it and no one could discover it is human invention.

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So in none of those cases was there a record where there was failed attempts to say, OK, there's the BRCA gene.

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Oh, we can't detect it.

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We tried this.

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We couldn't detect it.

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We tried this.

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We couldn't detect it.

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We tried this.

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We couldn't.

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Oh, Stanford came up with a way to detect it.

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Oh, those are test tubes.

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Those are old.

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But no one was doing this, that, and the other to find it.

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It's proven.

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So in other words, you may believe at the end of it.

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What do you think's the closest case from either the Supreme Court or us on this point that helps you?

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I think that both cells direct and the Illumina case are examples of where laboratory techniques that are known.

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I argued the Illumina case in front of Judge Laurie.

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It was simple separation techniques for length of DNA.

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was old techniques there was nothing.

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That was a method of manufacturing.

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The labeling system, that's where this case is going to get decided wrong if this keeps up, which is the labeling of these things is descriptive, not prescriptive.

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So just because you put it in the bucket of detecting, even though it says quantifying, doesn't mean that there can't be human invention in the process of how it was measured.

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And the real point is

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that that's the claimed event.

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You may come up and people may say, okay, all those methods are obvious, right?

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It was known high throughput sequencing.

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That's one thing, but that's a different inquiry.

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The inquiry here is, what did you claim you invented?

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We claim we invented a measurement technique.

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At least in 652 and 497, you claimed a method of detecting, which you have agreed you didn't invent.

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Well, yeah, we definitely didn't invent just detecting, because it's in the prior art.

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It's method of quantifying, and that's step F. Every single one of them has quantification in it.

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It's not true to say it's mere detection.

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607 is a method of quantifying, yes.

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All of them have a step of quantifying.

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But the other point that I want to make, and this really just destroys the point that once you get to Athena and all those cases, there's never a measurement case of a natural law that can ever be impatented.

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And that is the Supreme Court statement in Deer.

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It is now commonplace that an application of a law in nature

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or mathematical formula to a known structure process may well be deserving of patent prosecution, repeated in Bilski, repeated in Mayo.

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It is not true that taking a known process and applying it to a natural law is per se unpatentable.

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That's what the Supreme Court said.

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They say it's routine that you can do it.

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The issue is, what did we claim to have invented?

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Did we claim to have invented that we detected it, like all of those other cases that have been listed?

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No, we did not.

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We claimed we have a measurement method that a decade of failures weren't able to find.

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And I'm happy to answer any questions on that.

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I don't see where the logic fails at all there.

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The difference between step two and step one is, what are they saying they invented?

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We don't have to believe them that it's invented, because there's other measurements of that.

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They're saying they invented a measurement method, which is a human thing.

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Oh, we're skeptical because this PCR was known, whatever.

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That's 102, 103.

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We're not saying that the discovery was the invention.

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We're saying that the method was invented.

[00:12:47] Speaker 00:
Mr. Reinus, I think we have your point.

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Shall we save your rebuttal time?

[00:12:52] Speaker 04:
Please do.

[00:12:54] Speaker 00:
Mr. Jay, you are splitting your time with Mr. Bell.

[00:13:00] Speaker 03:
That's correct, Your Honor.

[00:13:01] Speaker 03:
I represent Eurofins.

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Mr. Bell represents Natara.

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We're both prepared to address all of the issues on the common patent 652.

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To the extent there's any difference on the two patents that are asserted only against Natara, Mr. Bell will address those.

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But with the court's permission, I'd like to start.

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right where Mr. Renish left off, which is what is this patent directed to?

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And based on the claims and the specification, this is a patent that's directed to observing the natural phenomenon.

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If you look at the end of that last step of the 652 patent, you'll see that any increase in the quantity of the donor's cell-free DNA over any amount of time

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That's the claim result that is detected.

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That's why it's a method of detecting.

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That's why it is an attempt to claim the observation of the natural phenomenon.

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One of the patents recites a method of quantifying.

[00:14:03] Speaker 03:
I think that's right.

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I mean, that's one of the other patterns.

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That's not your issue.

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Not your problem.

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I think Mr. Bell, I'm sure, is going to have a lot to say about that.

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And I don't want to get out in front of him on that.

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But I do think that Mr. Reines says that they're all about quantifying.

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And certainly, for this pattern,

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The quantification is not about determining the number at which the technology works or identifying a level that represents an innovative application of the natural phenomenon.

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It just claims the increase in the quantity being indicative of transplant rejection.

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And that is the natural phenomenon.

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And I think that that's backed up by the first paragraph of the summary of the invention in column two, where it synthesizes

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the claimed method into about three steps, and you don't see the measurement technique being discussed there at all.

[00:15:02] Speaker 03:
It's just about the diagnostic result, that the increase in the donor's DNA in the recipient system over time is an indication that the organ may be failing.

[00:15:12] Speaker 01:
But isn't that a form of measuring?

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If you assess that there is an increase, haven't you measured, at least in the crude sense?

[00:15:20] Speaker 03:
Well, let me just say at the outset that I don't think that even if we agreed that this is a claim directed to measurement in the raw sense, or as you say, in the crude sense, I don't think that would make it patent eligible.

[00:15:34] Speaker 03:
I don't think it would make it directed to anything other than what this court has described as the observation of the natural phenomenon.

[00:15:39] Speaker 01:
So you're saying that at least at that form of rough

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That's just observation that doesn't cross the line into measurement.

[00:15:50] Speaker 03:
It's because it's just it's just observing an increase.

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That's right.

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And the the whole the natural phenomenon at issue is not that there might be donor DNA in a recipient system.

[00:16:04] Speaker 03:
The natural phenomenon is that if the organ is failing, the organ may generate more, may release more of the donor's DNA than it was before, and that may be that indication.

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That is the natural phenomenon, and I take that to be common ground.

[00:16:18] Speaker 03:
So all of this

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uh... the focus on snips on single nucleotide polymorphisms that's just about how do you what are you looking for what let what dna landmark in the strands of donor dna that's uh... or if it's very interesting dna that's floating around in the bloodstream cell free uh... that to tell that it's the donors rather than the recipients you know you could look at it and it was tried in the prior looking for white chromosomes

[00:16:48] Speaker 03:
if it's a female recipient and a male donor.

[00:16:51] Speaker 03:
So what we're talking about is not the technology, but just essentially what landmark do you point the telescope at?

[00:16:59] Speaker 03:
But the claim is just adding together the natural phenomenon, conventional technology for observing it, and claiming the result, which is that once you've identified the donor's DNA floating in the plasma, that an increase is indicative of organ failure.

[00:17:17] Speaker 03:
I think that really is the key point on step one.

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What is this claim directed to?

[00:17:32] Speaker 03:
The district court got step one wrong and also, of course, step two.

[00:17:38] Speaker 03:
But I think really on step one, this court in Athena pointed out that when the claim is directed to nothing but the observation of a natural phenomenon using conventional technology, that that is directed to the natural phenomenon itself.

[00:17:56] Speaker 00:
But can measurement of a natural phenomenon

[00:18:01] Speaker 00:
never be patent eligible?

[00:18:04] Speaker 03:
I wouldn't say that, Your Honor, and certainly at step one, this court has cases, not just from the life sciences, but this case has, sorry, this court has precedents in which an innovation is directed to an improvement in the way that a process works, and I suppose that could be

[00:18:26] Speaker 03:
and improvement in the measurement.

[00:18:28] Speaker 03:
Now, in Illumina and in CellsDirect, the two cases that my friend mentioned, I mean, the court, of course, said in Illumina that this is not a diagnostic case.

[00:18:38] Speaker 03:
It is a method of preparation case.

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And so to the extent that the method of preparation facilitates the observation, then this court said that the method of preparation can absolutely be patent eligible.

[00:18:50] Speaker 03:
But it has to be directed to how are you preparing the cells for observation?

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rather than a means of going about the observation itself and then claiming the result, the natural phenomenon, at the end of the process.

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And I think that really is the difference.

[00:19:05] Speaker 03:
And really, CellsDirect is no different, and this court has had the opportunity to distinguish CellsDirect on exactly that basis in a number of cases, including Roche and Cleveland Clinic, saying that that was a new and useful laboratory technique.

[00:19:20] Speaker 03:
Just quantification doesn't sound like the development of a laboratory technique.

[00:19:24] Speaker 03:
I think that it would take something more than saying to use typical quantification to make something innovative.

[00:19:34] Speaker 03:
And this specification says the opposite.

[00:19:35] Speaker 03:
When it's discussing quantifying, it says at column 18, at the bottom of column 18 up to the top of column 19, that quantifying can be done through a variety of means well known in the art.

[00:19:47] Speaker 03:
So I think that's the

[00:19:49] Speaker 00:
Mr. Reiner said these are not well known means for this purpose.

[00:19:55] Speaker 03:
Well, so I guess it depends on what that means, but under this court's cases, for example, in Ariosa,

[00:20:04] Speaker 03:
You know, the technology had never been used to measure that particular type of DNA in Roche.

[00:20:10] Speaker 03:
The technology had never been used to look for that particular type of bacterial DNA.

[00:20:15] Speaker 03:
But the point is that the technology itself was well established.

[00:20:19] Speaker 03:
And I think that's recited in the claim, sorry, in the specification.

[00:20:23] Speaker 03:
in quite some detail.

[00:20:26] Speaker 03:
And I think that really the telling point is that in the examples, example two and then again at columns 16 to 17, you see that they're not saying use our method, they're saying use the Illumina sequencer.

[00:20:38] Speaker 03:
This is an example of off-the-shelf technology to do the sequencing.

[00:20:41] Speaker 03:
And as far as the quantification goes, I mean I pointed the court to the bottom of column 18, methods for quantifying nucleic acids are known in the art and include high throughput genotyping.

[00:20:53] Speaker 03:
So I think as far as quantification goes, that's just an application of ordinary computing power.

[00:21:00] Speaker 03:
Really, it's just doing the comparison.

[00:21:02] Speaker 03:
Is this the donor's DNA or the recipient's DNA?

[00:21:06] Speaker 03:
And as the patent says at column 21, line 5, determining the presence or absence can be done through any suitable method known in the art.

[00:21:17] Speaker 00:
Thank you, Mr. Jay, Mr. Bell.

[00:21:19] Speaker 00:
Thank you.

[00:21:21] Speaker 05:
Good morning, your honor.

[00:21:22] Speaker 05:
May it please the court.

[00:21:24] Speaker 05:
Abril Bell for Natara.

[00:21:26] Speaker 05:
I'd like to start where my colleague left off and some of the questions that were raised for Mr. Reines and look specifically at some of those additional things that he says constitute an advance in the technology.

[00:21:38] Speaker 05:
And I think when you look at those, you'll find that they're nothing of the sort.

[00:21:41] Speaker 05:
And instead, the specification at every turn admits that what you're doing is using conventional existing technology to observe a natural phenomenon, whether you

[00:21:51] Speaker 05:
couch that as quantifying it or whether you couch it as diagnosing it or simply observing it, it all amounts to the same thing.

[00:21:59] Speaker 05:
The patent from the second word, the second word of the title, is diagnosing.

[00:22:04] Speaker 05:
In the summary of the invention, it talks about diagnosing these conditions.

[00:22:09] Speaker 05:
And so when you look at the actual plane limitations, and I'll focus on

[00:22:14] Speaker 05:
the two patents that are certain only against Nutera, while noting that they have the same specification, they're continuations of each other, and we think they all are of the same piece.

[00:22:25] Speaker 05:
Mr. Reines mentioned a couple of things, digital PCR, for example, and I think we can see how this is not the purported advance in at least two or three ways.

[00:22:35] Speaker 05:
First, the only claim that it's mentioned in is the 497 patent.

[00:22:40] Speaker 05:
Claim one of the 497, which is representative of those,

[00:22:43] Speaker 05:
There's no dispute about that in this proceeding.

[00:22:46] Speaker 05:
It's only mentioned once and very much in passing.

[00:22:49] Speaker 05:
It said you can use multiplex sequencing or DPCR.

[00:22:54] Speaker 05:
It's a purely optional limitation, and that's consistent with how the specification has treated all of these existing technological tools.

[00:23:02] Speaker 05:
It lists a litany of different PCR techniques that you could use, for example, at Column

[00:23:07] Speaker 05:
One of those is DPCR, but it mentions it as an existing technology, going back at least as far as 2006.

[00:23:16] Speaker 05:
In other words, it's not the purported advance.

[00:23:19] Speaker 05:
The claims don't recite it as the purported advance and don't tell you any details on how to use it in this context.

[00:23:26] Speaker 05:
To the extent there were challenges, and I don't think the specification suggests there were any particular challenges of applying it, but to the extent there were challenges,

[00:23:35] Speaker 05:
A patentee, in order to overcome the 101 eligibility hurdle, has to tell you how to make that adaptation.

[00:23:41] Speaker 05:
I think we see that, for example, in Athena.

[00:23:43] Speaker 05:
You can't just say, take this off-the-shelf technology and apply it in this new context.

[00:23:48] Speaker 05:
There, it was a brand-newly-discovered natural law.

[00:23:52] Speaker 05:
And here, we don't even have that.

[00:23:53] Speaker 00:
Mr. Reines says it took 10 years and thousands of people.

[00:23:59] Speaker 00:
Is all that irrelevant?

[00:24:01] Speaker 05:
It is, Your Honor.

[00:24:02] Speaker 05:
It is.

[00:24:02] Speaker 05:
When the face of the patent, when the face of the patent doesn't say anything about those challenges, the things that the patent talks about were attempts to observe other things that weren't quite as useful.

[00:24:14] Speaker 05:
For example, a Y chromosome appearing in the recipient.

[00:24:19] Speaker 05:
That's useful if the donor is male and the recipient is female.

[00:24:24] Speaker 05:
It's not useful if that's not the situation.

[00:24:26] Speaker 05:
And there are other drawbacks of that that weren't related to the technological measurement facilities or techniques available, but simply inherent in you're looking for the Y chromosome.

[00:24:37] Speaker 05:
And the HLALLs was another thing mentioned in the specification as being not quite as useful.

[00:24:44] Speaker 05:
Well, that's because those are often the same among multiple people, so it doesn't help you distinguish between recipient and donor.

[00:24:51] Speaker 05:
Nowhere in there does it say, here is why it was hard to apply, for example, DPCA, here's why it was hard to do

[00:25:00] Speaker 05:
a thousand amplifications, nowhere do you see that anywhere.

[00:25:04] Speaker 05:
Because to the contrary, it was saying, just use off-the-shelf technology.

[00:25:09] Speaker 05:
For example, the amplification of those thousand snips.

[00:25:14] Speaker 05:
I know my friend has mentioned that briefly, and that wasn't really the focus of the argument below in the summary judgment papers.

[00:25:22] Speaker 05:
It seems to become more of a focus now, but that thousand was just an arbitrary number.

[00:25:28] Speaker 05:
In other words, do more of it.

[00:25:30] Speaker 05:
If you look, for example, at column 11.

[00:25:33] Speaker 01:
Well, it doesn't have to be hard as such, right, in order to be inventive.

[00:25:38] Speaker 01:
I mean, you can just stumble over something that's actually quite easy and turns out to revolutionize an industry just because no one else had previously discovered or implemented that relatively easy step.

[00:25:54] Speaker 01:
So I don't know.

[00:25:57] Speaker 01:
Let me ask the question this way.

[00:26:00] Speaker 01:
Suppose that no one had previously ascertained that if you keep doing these procedures over and over again, you can actually increase the sensitivity of the testing to the point that you can actually come up with a quantification.

[00:26:18] Speaker 01:
Why wouldn't that be patentable?

[00:26:22] Speaker 05:
Because that wasn't what they purported to do here.

[00:26:25] Speaker 01:
Well, OK.

[00:26:25] Speaker 01:
But take my hypothetical, and we'll work backwards into this case.

[00:26:29] Speaker 01:
Would you agree that that might well be patentable?

[00:26:32] Speaker 05:
It could be.

[00:26:33] Speaker 05:
For example, in the Cells Direct case, there you had something freezing the hepatocytes that was not done multiple times because- Right.

[00:26:41] Speaker 01:
But as Judge Lurie pointed out, that was a method of preparation.

[00:26:45] Speaker 05:
I agree.

[00:26:45] Speaker 05:
And it's distinguishable on that basis as well.

[00:26:47] Speaker 05:
But I was trying to find a case that fit your honor's hypothetical that, in that case,

[00:26:53] Speaker 05:
the discovery was, and there it was, that, hey, you could actually do this multiple times and get some benefits that we didn't know about before, in fact, that we thought we couldn't do before because it would destroy the hepatocytes.

[00:27:05] Speaker 05:
So that might be around where there could be something patent-eligible.

[00:27:09] Speaker 05:
And I think in the computer context, you'll find some cases like that as well.

[00:27:13] Speaker 05:
But the important point here is the patent says, for example, that that higher sensitivity

[00:27:18] Speaker 05:
That's kind of a bucket of things that includes the various limitations like the .03 donor composition, the 1.5 error rate, the 1,000 SNPs are all getting at, let's have a better result.

[00:27:30] Speaker 05:
But the higher sensitivity, the patent says, was simply by sequencing more.

[00:27:35] Speaker 05:
And you could do it using a commercial Illumina genome analyzer.

[00:27:38] Speaker 05:
That's at column 17.

[00:27:40] Speaker 05:
And the expert admitted in this case, Care DX's expert admitted, that the fact of doing it more to get better results was, quote, known and accepted in the art.

[00:27:52] Speaker 05:
I don't think it applies here because they don't purport to have invented the notion that doing it more will get you better results or sequencing error to get the error rate down to, for example, 1.5%.

[00:28:05] Speaker 01:
Well, I think they are saying if you do it more, you get better results, right?

[00:28:10] Speaker 05:
Well, they're saying do all of these things together and do more of it ultimately creates a better process.

[00:28:17] Speaker 05:
But I don't think they will say that they came up with the notion.

[00:28:21] Speaker 01:
Well, it's a different question.

[00:28:22] Speaker 05:
Right.

[00:28:23] Speaker 05:
Right.

[00:28:23] Speaker 05:
Yes.

[00:28:24] Speaker 05:
And I see the amount of my time, but I'm happy to answer any additional questions if the court has it.

[00:28:29] Speaker 05:
We think the decision should be affirmed.

[00:28:31] Speaker 00:
It's not.

[00:28:32] Speaker 00:
Mr. Reinus has a couple of minutes, and we'd appreciate it if you didn't shout at us as you did earlier.

[00:28:39] Speaker 04:
I will refrain from doing so, Your Honor.

[00:28:41] Speaker 04:
Sorry about that.

[00:28:42] Speaker 04:
I'm energized.

[00:28:43] Speaker 04:
Apologize.

[00:28:45] Speaker 04:
With respect to the 652 patent, the 56%

[00:28:51] Speaker 04:
sensitivity is a statistic that requires a certain amount of quantification.

[00:28:55] Speaker 04:
These are methods of quantification, not simple detection.

[00:28:59] Speaker 04:
And Judge Laurie, you were on it with, does the 10 years of failed efforts to try and detect the CFDN and A in a way that you could quantify it for purposes of this invention, is that relevant or not?

[00:29:13] Speaker 04:
And I really want you to think about that, and everyone should think about it.

[00:29:16] Speaker 04:
It is not irrelevant.

[00:29:18] Speaker 04:
It cannot be irrelevant.

[00:29:20] Speaker 04:
The, as Judge Bryson pointed out, sometimes the strategy, and we heard that in the prior cases, of how you go about solving a problem is as important as the technical difficulty.

[00:29:30] Speaker 04:
And this was a strategy that no group did for 10 years.

[00:29:34] Speaker 00:
Everyone wanted to find... That relates to obviousness.

[00:29:38] Speaker 04:
If the point is, if it's not obvious because of human invention, then it's certainly not unpatentable subject matter.

[00:29:47] Speaker 04:
Also, on the question of are these new techniques or not, the district court itself denied summary judgment, identifying all the evidence that the different techniques that we've been talking about were in their infancy at this point in time.

[00:30:06] Speaker 04:
You know, it's your rule 36 and ignore all this, right?

[00:30:10] Speaker 04:
That happened.

[00:30:10] Speaker 04:
That's A66 and 67.

[00:30:12] Speaker 04:
So, you know, even the evidence shows that this was, that these techniques were cutting edge.

[00:30:18] Speaker 04:
Even if you look at it on a step two basis,

[00:30:21] Speaker 04:
you don't get there.

[00:30:22] Speaker 04:
And then the other point is magistrate Judge Burke, who did the original decision, nailed it.

[00:30:27] Speaker 04:
Which is, it's not what did you actually meet obviousness and other requirements.

[00:30:33] Speaker 04:
It's what did you claim you did?

[00:30:35] Speaker 04:
And what they claim they did was they came up with the human innovation of a strategy for measuring the amount of DNA that would get to the specific thresholds that are in the claims or otherwise.

[00:30:46] Speaker 04:
that no one else had been able to do for 10 years and that one author at about the same time, Viamata Love, said was impractical to use cell-free DNA for this measurement.

[00:30:56] Speaker 04:
If this was like, and I'll finish on this point, if this was like the Ariosa case, in Ariosa, which I was involved with, no one argued that the PCR could just detect cell-free DNA at all, that that was a challenge, that people had been trying, they knew cell-free DNA was there, they just couldn't come up with a good way to detect it or measure it.

[00:31:16] Speaker 04:
This case is wholly different.

[00:31:19] Speaker 04:
All that we're asking is that it be recognized that the claimed advance here, which was never analyzed by the district court because he didn't believe there was a step one.

[00:31:26] Speaker 04:
that the claimed advance is this improved measurement method.

[00:31:30] Speaker 04:
It may be that it's obvious.

[00:31:32] Speaker 04:
We don't think so obviously.

[00:31:33] Speaker 04:
That is obvious.

[00:31:35] Speaker 04:
But this can't be just dumped in the bucket with Athena and Cleveland Clinic and other places where there really wasn't a genuine debate as to whether the method of measurement or detection was innovative itself from a human perspective.

[00:31:49] Speaker 04:
And I really appreciate it.

[00:31:50] Speaker 04:
If I was a bit loud before I apologize, this is an important one to me.

[00:31:53] Speaker 00:
Thank you, Mr. Reines.

[00:31:54] Speaker 00:
So the case is submitted.

[00:31:56] Speaker 00:
And that concludes our arguments for this morning.