Trials@uspto.gov
`571-272-7822
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`Paper 52
`Entered: July 27, 2020
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALERE INC.,
`Petitioner,
`
`v.
`
`REMBRANDT DIAGNOSTICS, LP,
`Patent Owner.
`____________
`
`IPR2016-01502
`Patent 6,548,019 B1
`____________
`
`Record of Oral Hearing
`Held: June 22, 2020
`____________
`
`Before CHRISTOPHER J. CRUMBLEY, JON B. TORNQUIST, and
`KIMBERLY MCGRAW, Administrative Patent Judges.
`
`
`
`
`571-272-7822
`
`
`
`
`
`Paper 52
`Entered: July 27, 2020
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALERE INC.,
`Petitioner,
`
`v.
`
`REMBRANDT DIAGNOSTICS, LP,
`Patent Owner.
`____________
`
`IPR2016-01502
`Patent 6,548,019 B1
`____________
`
`Record of Oral Hearing
`Held: June 22, 2020
`____________
`
`Before CHRISTOPHER J. CRUMBLEY, JON B. TORNQUIST, and
`KIMBERLY MCGRAW, Administrative Patent Judges.
`
`
`
`
`
`IPR2016-01502
`Patent 6,548,019 B1
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
` AMANDA HOLLIS, ESQUIRE
` KOURTNEY BALTZER, ESQUIRE
` DANIEL GROSS, ESQUIRE
` Kirkland and Ellis LLP
` 300 North LaSalle
` Chicago, Illinois 60654
`
`ALSO APPEARING:
`
`
`JENNIFER EMBRY, ESQUIRE
`Senior Counsel Abbott Laboratories
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`JOSEPH JENNINGS, ESQUIRE
`JARED BUNKER, ESQUIRE
`Knobbe Martens Olson and Bear
`2040 Main Street
`Irvine, California 92614
`
`
`
`
`The above-entitled matter came on for hearing on Monday, June 22,
`2020, commencing at 1:00 p.m., EDT, by video/by telephone.
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`IPR2016-01502
`Patent 6,548,019 B1
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`
`P R O C E E D I N G S
`- - - - -
`JUDGE TORNQUIST: Good afternoon. This is a video hearing for
`IPR 2016-1502, Alere Inc. v. Rembrandt Diagnostics. Who do we have
`from Petitioner today?
`MS. HOLLIS: Good afternoon. You have Amanda Hollis from
`Kirkland and Ellis. I'm joined on the phone by my colleague, Kourtney
`Baltzer and Daniel Gross also from Kirkland and Ellis; and we also have
`Jennifer Embry, Senior Counsel at Abbot Laboratories which now also
`(inaudible).
`JUDGE TORNQUIST: Okay, welcome; and Patent Owner?
`MR. BUNKER: Good afternoon, Your Honors. Jared Bunker, for the
`Patent Owner, backup attorney. With me in the room is Joseph Jennings,
`lead attorney. We're trying to be socially distant. So, he's off the camera.
`JUDGE TORNQUIST: Okay, perfect. Per our hearing order, each
`side will have one hour of total argument time today. Petitioner, bearing the
`burden of proof, you'll go first and reserve time for rebuttal. And we'll hear
`from Patent Owner. You can also reserve a short period of time for sur-
`rebuttal. As we're on video here today, there's going to be a short lag
`between the Judges' questions coming on line, so if you hear us coming on
`line just pause a second, listen to the question, and make sure that it's
`finished before you answer.
`If you have any difficulty seeing, but especially hearing, please let us
`know and we'll get with the technical staff and make sure everyone can hear
`the hearing going forward. All right, with that, Petitioner, when you're
`ready.
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`MS. HOLLIS: Thank you, Your Honor. One question -- I do not see
`the Judges any more on the screen. They were present when the -- there we
`go, okay.
`JUDGE TORNQUIST: Okay.
`MS. HOLLIS: Okay; thank you.
`JUDGE TORNQUIST: And do you want to reserve any rebuttal
`
`time?
`
`MS. HOLLIS: Yes, Your Honor. I'm going to reserve approximately
`10 minutes, if that's okay. Will I get a notice or should I keep my own
`clock?
`JUDGE TORNQUIST: I'll give you a notice about 1 minute before
`your 10 minutes is about to hit.
`MS. HOLLIS: Okay; thank you, Your Honor. So, before I get into
`the merits of our challenges, I'd like to address one procedural question, and
`that question is whether the Board should be revisiting its decision that
`claims 3 through 5 were not obvious over our ground 2 challenge, the
`challenge based on Cipkowski and McKay, now that we're here back on
`remand. And the answer to that question, I submit, yeah, there should be a
`revisiting of that. And it is because of the following: First, we are on a
`remand from the Federal Circuit. As I show in my slide 2, the instruction
`here from the Federal Circuit is that they vacated the remainder of the
`Board's final written decision. So, everything except for the claim
`construction, the (inaudible) is now vacated. That, of course, would include
`the final written official decision, its conclusion on that ground; and remand
`for the Board to review all claims and grounds included in the Petition; and
`to issue a complete final written decision.
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`Also, the record has changed. It never (inaudible) on the Rembrandt
`side since that 2018 final written decision. Remember, that final written
`decision in 2018 cited an expert declaration from Rembrandt. That expert
`declaration did conclude, or opine, that the challenge was not enough to
`render the claims not obvious. But he made a few preliminary findings that
`have since been rejected, and now Rembrandt has no expert standing by it
`when it's arguing to you that despite all this happen, those claims are still
`somehow not obvious.
`And one of those preliminary findings by that expert was, for
`example, he believed all of the elements of claim 1 were not present in the
`McKay reference. Well, that was rejected. He also opined that the claim
`required things like a single-step device and a single, unitary structure. And
`those are very important to his opinion because, remember, when he
`discusses the advantages of the patent claims over the prior art combination,
`that's what he's relying on, the single-step and the single-unitary structure.
`Now that those theories and arguments like Rembrandt's have been
`rejected, there is no expert standing by Rembrandt's side and, so, for that
`reason alone, we do think that the Board should be taking another look at
`that ground.
`JUDGE TORNQUIST: Okay. Let me ask you a question on that
`then. This is Judge Tornquist. Would you agree though that the Petitioner
`had a full and fair opportunity to address, in that first trial, the question of
`whether claims 3 through 5 were obvious over Cipkowski and McKay?
`MS. HOLLIS: Well, we did have a trial; we had the briefing; we had
`the argument. What we didn't emphasize or focus on as much back then
`because Rembrandt would have argued it wouldn't matter, was how the
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`combination device, Rembrandt's vision of the McKay/Cipkowski combo,
`it's still capable of needing that wherein clause allowing liquid to enter the
`container for reasons like the holder can be removed. It can be assembled in
`a way that Rembrandt is not assuming. So, we did have an opportunity, but
`things have changed, and what we're doing now is pointing out the flaws in
`Rembrandt's argument.
`JUDGE TORNQUIST: I understand. I guess the question, though, is
`the claim construction question was front and center between the parties
`during that first trial. So, the question of what would happen if the
`construction went against Petitioner was there and Petitioner didn't, at least
`what we found, didn't address it appropriately. So, why have an extra
`chance at it?
`MS. HOLLIS: Your Honor, it's not really an extra chance because
`what we're doing now we're addressing this ground in the context of the
`current record, which, of course, if this goes on appeal, the Federal Circuit
`will do; but we believe the Board should look at the current record and look
`at that challenge through the current record just like the Federal Circuit will.
`So, it's not a redo in that sense, but looking at the current record.
`And, again, what I'm pointing out here is first of all, we're not doing
`anything impermissible as Rembrandt argued. Rembrandt argued that you
`guys should be ignoring our explanation for why the Rembrandt vision of
`the McKay/Cipkowski combination is flawed. Why their arguments around
`that is flawed. So, the waiver cases that they cite are nowhere close to this
`case. And, really, unless we are in a waiver circumstance, I'm not
`understanding, or seeing, the legal basis to just ignore what we are saying
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`now, particularly in view of a new record. And I can explain what I mean
`about those cases.
`Those cases were the Intelligent Biosystems case and the Henny Penny
`case. And, presumably, Rembrandt picked the closes cases that they can
`find to this one? And, like I said, they are nowhere near. In Intelligent
`Biosystems one was the one where they injected new references; okay, new
`non-patent literature references. They were relying on new references.
`We're not doing that at all. We're relying on the same references. And the
`Henny Penny case, that's the other one that they rely on, the Petitioner
`switched from saying that you should look at the combination of references
`to flipping and saying everything was present in one prior art reference.
`We're doing nothing of the sort. So, that's another reason why I think the
`Board should be taking a look at that ground again.
`JUDGE CRUMBLEY: Counsel, you keep saying that things have
`changed. And I'm going to sort of pin you down on exactly what you're
`going to argue. Are you referencing the new declaration that we have? Is
`that what's changed now?
`MS. HOLLIS: I'm referencing the new non-existence of a supportive
`expert declaration on Rembrandt's side. Before 2018's final written decision,
`there was an expert willing to say these claims are non-obvious. Rembrandt
`had that, and the Board cited that in reaching a final written decision. Now,
`there's no expert that they cite and there's no expert declaration supporting
`their view that these claims are still non-obvious despite these changes in
`claim construction theories that have happened. That's what I'm saying.
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`JUDGE CRUMBLEY: I mean, you're not contending that they have
`withdrawn their prior declaration. I mean it's still in the record. It's still
`evidence in this case.
`MS. HOLLIS: Well, it's still in the record. They don't cite it, and for
`good reason. It doesn't actually provide any expert opinion that the claims
`are non-obvious in light of the new decided constructions that went against
`Rembrandt -- the single-step construction, the single-unitary piece
`construction -- those theories, those construction theories, were rejected by
`the Board. And that expert used those theories to get to his opinion in the
`first trial that the claims were non-obvious. (Inaudible).
`JUDGE CRUMBLEY: Well, but I, you know, I remember
`Rembrandt correctly, and please tell me if I'm wrong. On remand, we said
`the parties shouldn't address the instituted grounds, that they should address
`non-instituted grounds. But what I think I'm hearing you say is that you're
`faulting the Patent Owner for not submitting a declaration as to, against two
`of your grounds which would be in violation of our order, wouldn't it?
`MS. HOLLIS: No, Your Honor. First of all, Rembrandt didn't
`interpret that order to preclude argument on the ground 2 challenge to claims
`3 through 5. They're the ones that went first and they not only identified that
`as a disputed ground, they briefed it in their new brief. So, it's actually not
`fair to them to (inaudible).
`JUDGE CRUMBLEY: I'm sorry, putting aside what you think
`Rembrandt did, what did we order? My understanding was that we said
`we're having a trial now to address the obviousness to your claims that are
`now back to us on remand because of the SAS issue. And that's what we
`ordered the parties to do. Are you saying that my understanding of that
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`order is incorrect, that the parties should have been addressing the instituted
`grounds or not?
`MS. HOLLIS: I'm not, Your Honor. But it doesn't matter because
`what the Federal Circuit would review later if it's appealed would be the
`complete record. There is an instruction in the Federal Circuit's opinion that
`all claims and grounds be reviewed, and the record is now fuller than it was
`in 2018. (inaudible).
`JUDGE CRUMBLEY: Did anything in the Federal Circuit's decision
`reach the issue of grounds 3 through 5 on (inaudible)?
`MS. HOLLIS: No. And it didn't say that the Board's decision on that
`was correct in any way.
`JUDGE CRUMBLEY: Right. They didn't examine it at all, right.
`So, their choices were to affirm, reverse or, since they weren't going to touch
`it, vacate, right. And that's what they did. They vacated it, which doesn't
`signal to me anything that we can't correct. It just signals that they weren't
`reaching those issues, correct?
`MS. HOLLIS: You're correct, Your Honor, you're correct.
`JUDGE CRUMBLEY: So, I guess my question to you is why
`shouldn't we then at that point rely on what we did before? We've already
`heard the parties argue these issues. We reasoned with the issues and
`decided the case on those issues. And the Federal Circuit hasn't disturbed
`that in any way. It tells us it (inaudible). So, it almost seems like a law of
`case-type situation, well, why are we going back to something we've done
`before?
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`MS. HOLLIS: It is well established that a vacated decision is not
`going over the case. That's a Supreme Court Johnson decision that
`(inaudible).
`JUDGE CRUMBLEY: Sure. But I'm saying in terms of judicial
`efficiency purposes, why should we be going back and refiling those
`grounds if the Federal Circuit's decision didn't disturb the prior reasoning in
`any way?
`MS. HOLLIS: Well, it did vacate that. So, if what you're saying is, is
`there anything wrong with just saying well, we decided this before and we're
`going to repeat that again? I do think there would be something legally
`incorrect about saying that you must; but also I just think you have to,
`according to the Federal Circuit, address the claims and grounds. And if you
`just ignore the record, I don't see how that's going to be a correct review of
`all the claims and grounds, Your Honor, despite what the briefing order said,
`which I don't disagree with your opinion, Your Honor, but at the end of the
`day, the Board does have to reach a final written decision, a complete final
`written decision, including this one. It could (inaudible), I suppose, what it
`did before. I actually don't think that would be the correct result.
`JUDGE CRUMBLEY: Okay; thank you.
`MS. HOLLIS: Yes. Let me begin with a brief overview of the '019
`Patent, and then I'm going to go straight into the grounds, starting with the
`McKay ground combining the Charm and May references. So, the '019
`Patent (inaudible), and I'm on my slide 4, is directed to a device that does
`both testing and collecting of biological fluid. These could be pee cups,
`things that employers use to test urine for drug use, for example.
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`And if you go to my slide 5, these devices can be described as
`reference to claim 1. They have a number of flow-control channels, that's
`shown in blue in the example figures on the right. It's got the assay test
`strips that flow within the flow-control channel. It has the sample fluid
`container with the base, the opened mouth, and the walls connecting the base
`to the mouth. That's shown in the orange on figure 6. And it has these
`wherein features that's highlighted in green and yellow --
`COURT REPORTER: Ms. Hollis, I'm having a hard time hearing
`you. Can you move closer to your speaker or the screen, please?
`MS. HOLLIS: Yes, I am very close to my speaker. Can you hear me
`
`now?
`
`COURT REPORTER: Much better. Thank you.
`MS. HOLLIS: Sure. So, it has these wherein features, as well. The
`green one is the one that the Federal Circuit construed and affirmed; and that
`one, as construed, remember, is a structural capability requirement. It
`requires a structural capability to allow liquids into the container when the
`flow-control channel is disclosed inside the container and that liquid should
`also be able to go directly to the assay test strips sample loading zone in the
`channel.
`The Federal Circuit was clear there are no method steps in these
`claims; there are no temporal steps in this claim, or requirements in this
`claim. It's a structural capability. If you see, for example, on that figure 6,
`which Mr. Jennings identified as a complete embodiment of the invention
`last time we were here at the oral argument, that container has the structural
`capability -- you know, you can remove that cap and liquid can enter the
`container while the flow-control channel dispose therein.
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`The claim also has a pressure element, and what's interesting about
`that one is during the original prosecution of this patent, the Applicants
`relied on the pressure feature of the claim and the lack of an intermediate
`structure. That is what they were relying on, or was arguing in the first
`instance, that there was something inventive here. Now, however,
`Rembrandt doesn't rely on those features. They're not arguing that those are
`the ones that supports (phonetic) the prior art; and we've shown that they
`existed already in references like McKay and Lee-Own. And also
`Rembrandt has disclaimed the claims that recite them, including the sole
`independent claim 1. What's left, as you turn to my next slide, are the
`dependent claims. This is slide 6.
`The dependent claims are the ones we're challenging, and these add-
`on features that were always in the prior art and they're being used for things
`in the invention for which they were already known in the prior art. For
`example, claim 3. That one adds the liquid impervious backing and the
`holder fittable inside. That word is going to be important later, fittable. The
`fluid sample container and holder of having at least one slot, one therein, to
`receive the backing. All of that is undisputed. It's already in the Tydings
`reference. When we get to that you're going to see the pictures and the
`descriptions are exactly the same. It uses the same stories contained on the
`next slide with claims 4 through 6. This is slide 7. Four through six, 4 adds
`the curved shape of the container, the holder that follows the curvature.
`Claim 5 adds the cup, and claim 6 adds the watertight cap. These things are
`things that were known in the prior art but Applicants were using for things
`that were already known to the prior art. And, I -- let's just finish this off,
`and I'm going to get to my common point here.
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`Claim 10, that's the last thing that we're challenging. That depends on
`claim 9, which depends on claim 1. That one adds this idea of having
`multiple analyte test strips to detect the presence or absence of multiple
`things in a sample fluid container; and that those have to be in a single flow
`control channel. I'm going to get to this. Both Charm and May disclose that
`already; but look at what the '019 Patent itself says about this. I got that
`excerpted on the bottom of this slide. They say, in view of the foregoing
`teaching in the '019 Patent concerning the roll of ambient pressure
`equilibrium in flow rate control, those of ordinary skill in the art will
`appreciate that flow restriction could also be provided by alternative flow
`control channel design, e.g., flow control channel 34 may be continuous in
`width so all the test strips are disclosed within the same air pocket defined
`by the flow control channel. They're the same, right there. Once you
`understand the teaching about the role of ambient pressure in the flow
`control channel might be reading a flow, you will appreciate, as one of skill
`in the art the idea for a single channel holding all the strips. And, remember,
`Rembrandt doesn't dispute that its (inaudible) invention in that feature was
`known in the prior art, like the McKay reference.
`So, like I said, there's a common theme here. The Applicants in these
`claims were adding pieces that were already known and was being used to
`the same things that they were being used for in the art. And I agree that lots
`of inventions, most inventions, are at some level using pieces or combining
`pieces that were known before, but there has to be something inventive
`about that combination. There has to be something non-obvious about that
`combination.
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`Usually, when patent owner patents their challenge, they're bringing
`new evidence; they're bringing new arguments as to why when they combine
`these old things, something unexpected happens, something new was
`achieved. And you actually don't hear any story like that (inaudible).
`With that introduction, I'm going to go into my ground 4 challenge.
`That begins on my slide 35. And that challenge is to claim 10. It's obvious
`over the McKay reference in view of the Charm and May references.
`JUDGE TORNQUIST: So, before we go into this ground, can I ask
`one preliminary question for this? There's a parallel district court action,
`what claims were at issue in the parallel district court action?
`MS. HOLLIS: Claim 10. If you're talking about through the entire
`district court action, claim 10. Other claims fell out, like claims 3 through 5.
`The only one that the parties (inaudible).
`JUDGE TORNQUIST: Okay. Are there any findings or conclusions
`from the district court, or the jury in that case, that are relevant to our
`analysis of claim 10?
`MS. HOLLIS: Certainly not on the combination of McKay and
`Charm or May, this ground.
`JUDGE TORNQUIST: Okay. Our record is incomplete. So, we
`don't know exactly what is happening in that other case. I just wanted to
`make sure I understood what was being argued there with respect to claim
`10.
`
`MS. HOLLIS: Okay. I mean we obviously argued that claim was
`invalid, but we weren't using the set of grounds that are before you, by any
`means, and certainly not this ground, ground 4. And we also, you know,
`Rembrandt is taking inconsistent position for its infringement (phonetic) and
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`its invalidity case. So, in that district court action, we did rely on the
`Guirguis reference, I believe; but I don't think that's even in this one. And it
`was sort of if you don't find this infringed, you must find its invalid over
`that. I'm sure Mr. Bunker will correct me if he's remembering anything
`helps.
`JUDGE TORNQUIST: Okay; thank you.
`MS. HOLLIS: So, claim 10, remember that's the one that has the
`multiple test strips in the single flow control channel, depends on claim 9,
`which depends on claim 1. I'm turning to my slide 36. This is a direct quote
`from the Board's final written decision in 2018, "McKay discloses every
`limitation of claim 1." So, that was already addressed. And then you
`wonder why Rembrandt's not disputing that again. Everything that's in their
`claim 1, that Rembrandt would allege about claim 1, is there.
`If you turn to my next slide 38, there's also no dispute that the idea for
`multiple strips being used simultaneously to test for the presence of multiple
`analytes in sample was in both the Charm and the May references. But to
`combine either of those you'd get that; and that's shown in the excerpts on
`the left of this slide. And here's the decision and the institution about that
`which Rembrandt doesn't challenge. Although the embodiments of Charm
`and May are shown with a single test strip disposed within their respective
`housing, those references disclose that multiple test strips may be used to
`test the multiple analytes and urine sample.
`And there's also no dispute that there's a motivation to combine
`McKay with the idea for a multi-test strip design. That's shown in my slide
`45. And, again, I can quote from the Institution Decision (inaudible) for
`this. It said on this record, Petitioner identified sufficiently where McKay,
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`and May, or Charm disclose the subject matter of claims 9 and 14, and
`provide the sufficient explanation as to why one of ordinary skill in the art
`would have a thought to incorporate multiple test strips in McKay in view of
`the disclosures of Charm and May. And they don't dispute today that there
`was a motivation -- I mean this is why people were doing it. You want
`multiple strips to make a more efficient device.
`So, what's the question? And I do mean a question because they don't
`have evidence on their side disputing our evidence in the form of expert
`testimony that all of the elements in claim 10, and claim 9, and claim 1 are
`obvious of the prior art. What's the question that Rembrandt is raising here?
`Well, they say that the Charm and May references could be talking about a
`multi-strip design where each strip is in its own housing, like the Tydings
`reference, as opposed to each of the multiple strips, or all the multiple strips,
`seen in the single housing. But let's look at what May and Charm actually
`say about that.
`If you look at slide 39, there is May, and on the right I've
`reproducedMay's depiction of the device and the channel. The channels in
`May are either called hollow casings or housing. So, in May, it says a
`typical embodiment of the invention is an analytical test device comprising a
`hollow casing. Then they say a device according to the invention can
`incorporate two or more discrete bodies invented for multiple strips. So, the
`text of May discloses really one idea: A single device, a single hollowed
`casing, multiple strips.
`Rembrandt thought that when someone's reading this they may also
`think of a structure where each strip is in individual flow control channels,
`or individual casings, that's a fine idea and that might also be obvious
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`(inaudible), but that is not the idea that is discussed in May; and the same is
`true of Charm. If you take a look at slide 40 --
`JUDGE TORNQUIST: Counselor, may I ask you a question? Why
`does the disclosure of a hollow casing suggest that it's only one channel?
`Couldn't you just simply have a plastic strip up the middle of your hollow
`casing that separated two channels?
`MS. HOLLIS: That is nowhere discussed though in May or Charm.
`So, this kind of goes to the point; you could think of ways, I suppose, other
`new ways, other alternatives, but that's not the way that the May and Charm
`text is describing. They only (inaudible).
`JUDGE TORNQUIST: They don't describe any, they describe
`multiple -- let me give you my understanding. They describe multiple strips,
`but they just leave it at that. They don't say how you're going to do it. Your
`proof for us is that there is a hollow casing. And what I'm saying is it's your
`burden, why does that evidence get you where you need to go or make it
`proper support for what your expert's saying?
`MS. HOLLIS: Because it's not just in a vacuum multiple strips. It
`says right here a device according to the invention can incorporate two or
`more discrete strips on its device, according to the invention. The only
`device according to the invention that's portrayed is a device that's right
`above, a device comprising a hollow casing. That's the invention.
`And Charm is similar. On slide 40, it says in this drawing, 1 through
`6, it shows the analyte test device which includes an elongated molded
`housing. And that whole paragraph is very specific about singular things
`and housing of one-piece, injection-molded, transparent styrene polymer
`device and elongated cavity, and open end. And then below where they talk
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`about the multiple strips, it says the test device may employ one or more test
`strips.
`This notion that it's suggesting other ways, including ways that
`wouldn't have all these strips in a single channel, it's not there. It's not there.
`And just because there might be other ideas that are obvious, by no means
`makes the ones expressly disclosed non-obvious. And, Your Honors, there's
`no evidence on Rembrandt's side that disagrees with our evidence showing
`how one skilled in the art would read this. Our evidence is undisputed.
`What are they bringing? That's on my slide 48. They're saying things
`like well, there are some things in McKay that talk about specific structures
`like support to position the strip away from the wall of the holder. It talks
`about inner dimensions of the holder tailored to the size and shape of the test
`strips and the conviction of events. They're pointing to structural
`descriptions in McKay, some details in there, and saying because those
`details are there, someone would not have an expectation of success. There's
`not enough structural description for how to do a single flow control panel
`design. But there's actually no logic or evidence saying why these pose an
`obstacle, and they're misinterpreting the law of obviousness on this.
`Slide 81, Your Honor, I have a quote here from the Federal Circuit
`decision in 2018, PGS decision. “That argument relies on the presumption
`that one of skill in the art would blindly incorporate the prior art’s exact
`methodology into another reference. But the Board properly did not view
`the proposed combination to be so limited.” You also don't rely on the
`preferred embodiment of the prior art and look only at that, and that's what
`they're doing. It's very hypocriticalof them to be demanding more structural
`descriptions for a single flow control channel having multiple strips in it.
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`Look at my slide 51 and what they say in their own patent. They're
`claiming the universe (phonetic) of single flow control channel devices.
`There are no structural limitations on that in the claims. They're claiming
`the universe.. And their own patent says nothing more about the structural
`way they accomplished it. They just talk about the function, the same thing
`that the prior art does, as I've shown.
`With that, Your Honors, I'm going to move on to ground 5, which is
`our challenge to claims 3 through 6 as anticipated by the Lee-Own reference.
`Slide 57 shows the only elements that Rembrandt contends are missing from
`the Lee-Own reference, and that's a part of claim 3, the holder fittable inside
`the container with at least one slot formed therein to receive the backing; and
`claim 4's requirement that both the holder and the fluid sample container are
`curved in shape, and the curvature of the holder follows the curvature of the
`inner diameter of the fluid sample container.
`Just to orient everyone, I have on slide 60, a figure from Lee-Own, on
`the lower right-hand corner. That shows the Lee-Own sample fluid
`container. It shows the flow control channel, the undisputed flow control
`channel, inside the sample fluid container with the assay test strip. And so
`again, that flow control channel is not defying gravity there. There's
`s
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