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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INSTRUMENTATION LABORATORY COMPANY,
`Petitioner,
`
`v.
`
`HEMOSONICS LLC,
`Patent Owner.
`____________
`
`Case IPR2017-00852 (Patent 9,272,280 B2)
`Case IPR2017-00855 (Patent 9,410,971 B2)
`____________
`
`Record of Oral Hearing
`Held: June 12, 2018
`____________
`
`Before JO-ANNE M. KOKOSKI, KRISTINA M. KALAN, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges.
`
`
`
`5
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INSTRUMENTATION LABORATORY COMPANY,
`Petitioner,
`
`v.
`
`HEMOSONICS LLC,
`Patent Owner.
`____________
`
`Case IPR2017-00852 (Patent 9,272,280 B2)
`Case IPR2017-00855 (Patent 9,410,971 B2)
`____________
`
`Record of Oral Hearing
`Held: June 12, 2018
`____________
`
`Before JO-ANNE M. KOKOSKI, KRISTINA M. KALAN, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges.
`
`
`
`Case IPR2017-00852 (Patent 9,272,280 B2)
`Case IPR2017-00855 (Patent 9,410,971 B2)
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`STEPHEN Y. CHOW, ESQ.
`Hsuanyeh Law Group, PC
`11 Beacon Street, Suite 900
`Boston, Massachusetts 02108
`
` and
`
`GABRIEL GOLDMAN, ESQ.
`RONDA P. MOORE, D.V.M., ESQ.
`Burns & Levinson LLP
`125 Summer Street
`Boston, Massachusetts 02110
`
`ON BEHALF OF PATENT OWNER:
`
`BRIAN W. NOLAN, ESQ.
`YING-ZI YANG, ESQ.
`Mayer Brown LLP
`1221 Avenue of the Americas
`New York, New York 10020-1001
`
`The above-entitled matter came on for hearing on Tuesday,
`June 12, 2018, commencing at 1:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`Case IPR2017-00852 (Patent 9,272,280 B2)
`Case IPR2017-00855 (Patent 9,410,971 B2)
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`P R O C E E D I N G S
`- - - - -
`JUDGE ABRAHAM: Good afternoon. This is the
`consolidated oral hearing for IPR2017-00852 and 2017-00855.
`The 852 IPR relates to U.S. Patent Number 9,272,280 and the 855
`IPR relates to U.S. Patent Number 9,410,971.
`I am Judge Abraham, joined with me in the hearing
`room by Judge Kokoski, and Judge Kalan is with us in the
`Denver office. As you can see, she is joining us remotely, so you
`do have microphones in front of you, but I think it's best when
`you're speaking to make sure you're speaking into the microphone
`at the lectern, that way she will definitely be able to hear you.
`Also, she cannot see the screen that's in the room, but she does
`have your slides, so during your arguments, please refer to the
`slides by slide number to ensure that she can follow along.
`Okay, with that, I'm going to invite counsel for
`Petitioner to the lectern to introduce yourselves.
`MR. CHOW: Yes, for the Petitioner, lead counsel
`Stephen Chow of the Hsuanyeh Law Group of Boston,
`Massachusetts, and with me are Gabriel Goldman and Ronda
`Moore of the firm Burns & Levinson of Boston. We reserve 15
`minutes for rebuttal.
`JUDGE ABRAHAM: Okay. Thank you. I'm going to
`ask for appearances now from Patent Owner.
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`MR. NOLAN: Good afternoon, Your Honors, Brian
`Nolan of Mayer Brown for Patent Owner. With me is Ying-Zi
`Yang also from Mayer Brown for Patent Owner. We have extra
`copies of our slides, would you or your colleagues need those
`versions, or are you all set for the hearing?
`JUDGE ABRAHAM: We're okay. Have you provided
`one to our court reporter?
`MR. NOLAN: We have, Your Honor.
`JUDGE ABRAHAM: Okay. Welcome, everyone. Just
`a little bit of procedural matters. Petitioner, you will go first. You
`will have 30 minutes, I understand you want to reserve 15
`minutes. So we will start with that. Patent Owner, you will
`follow and you have 30 minutes for your arguments. And then,
`Petitioner, you have whatever rebuttal time you have left.
`We did receive the objections to the Patent Owner's
`slides. At the moment we're going to overrule those objections.
`Those demonstratives are just that, they are not evidence, they are
`just demonstratives. That said, if at any time during the
`arguments today you feel one side or the other has raised new
`arguments, you are free to bring that up at the lectern. I am not
`inviting interruptions during the other party's arguments, but if
`you feel a party has crossed the line and made new arguments,
`you are permitted to bring that to our attention when it is your
`time at the lectern, okay?
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`With that, I will invite Petitioner to the podium and you
`may begin.
`MR. CHOW: May it please the Board. The Board
`instituted review of grounds 1 of the 852 and 855 petitions to
`invalidate both claims of the '280 patent and claims 1, 2, 6, 7, 15
`and 16 of the '971 patent. For this presentation, I will refer to the
`common disclosure of the patents as Viola.
`Petitioner demonstrated in its petition claim charts that
`the Baugh patent discloses the limitations of the claims
`challenged on ground 1 of the 852 and 855 petitions. These
`claims are overbroad and not limited to assessing any specific
`aspect of the hemostasis process. Patent Owner now seeks to
`rewrite radically and impermissibly the meaning of those claim
`limitations in an attempt to avoid Baugh.
`In its preliminary responses, Patent Owner offered
`constructions for the following claim limitations. Referring to
`slide 2, one of these was "configured to be interrogated to
`determine a hemostatic parameter," which is required for each
`chamber of a multi-chamber device, and is claimed in both the
`'280 and '971 patents. And then looking at slide 5, "an
`interrogation device that measures at least one viscoelastic
`property of the test sample," which is claimed only in the '971
`patent.
`
`For this presentation, I will refer to the first limitation as
`the hemostatic parameter limitation and the second limitation as
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`the viscoelastic property limitation. Now, looking at slide 10, for
`the hemostatic parameter limitation, Patent Owner did not
`specify -- specifically construe the claim -- term "hemostatic
`parameter," rather, it allowed the plain meaning of the term to
`apply. Patent Owner's preliminary response construction for the
`"hemostatic parameter" limitation can be seen at the middle
`column of slide 10.
`JUDGE KOKOSKI: Counsel, why does it matter what
`they argued in the preliminary response? I mean, it was just that,
`it was preliminary. So they -- they were free to come back in
`their Patent Owner response and make a different argument.
`MR. CHOW: Yes.
`JUDGE KOKOSKI: If they so please.
`MR. CHOW: As far as the argument, Judge Kokoski,
`they are bringing up no new issues with respect to -- we contend
`that their new responses are improper because the original
`construction really was adequate. So that's one reason why we
`raise what was presented, and what the -- what the panel decided
`on was consistent with the -- with the -- with the specification and
`no new -- new presentation was necessary. That's the reason.
`JUDGE KOKOSKI: Okay.
`MR. CHOW: For this presentation -- so, looking at
`slide 10 again, for the hemostatic parameter, Patent Owner did
`not specifically construe the term "hemostatic parameter," but
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`rather allowed the plain meaning to apply. Patent Owner's
`preliminary response for the hemostatic parameter can be seen.
`Turning to the viscoelastic property limitation in slide
`20, Patent Owner offered that a viscoelastic property is to be
`construed as a property of a material that exhibits behavior that
`incorporates both elastic and viscous responses. Patent Owner's
`preliminary response construction for the viscoelastic property
`limitation can be seen in the middle column of slide 20.
`With respect to the viscoelastic property limitation,
`Patent Owner argued that Baugh did not disclose measurements
`of a viscoelastic property because Baugh's method of
`interrogation of the sample allegedly measures only viscosity.
`Patent Owner did not raise arguments with respect to the
`hemostatic limitation -- parameter limitation in either of its
`preliminary responses.
`On the record of the challenged patents and on Baugh,
`and the parties' arguments, this panel is to review based on a
`likelihood of success of grounds one. In doing so, the panel
`correctly determined that it was not necessary to construe
`formally the hemostatic parameter or viscoelastic property
`limitations. Even on the Patent Owner's then-proposed
`construction, these limitations were met by Baugh.
`On slide 3, the panel correctly adopted Petitioner's
`readings of Baugh that it discloses an -- that it discloses each of
`the limitations of claim 1 of the '280 patent, including a plunger
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`assembly used to measure the coagulation properties, thereby
`meeting the unconstrued limitation of determination of a
`hemostatic parameter.
`Slide 6 shows the panel correctly adopted Petitioner's
`readings of Baugh that it discloses each of the limitations of claim
`1 of the '971 patent, including one, the hemostatic parameter
`limitation, just discussed, and a plunger assembly that measures
`changes in the property of a fluid in a reaction chamber as a result
`of the onset or occurrence of a coagulation related activity,
`thereby meeting the Patent Owner's construed limitation of
`measuring a property of a material that exhibits behavior that
`incorporates both elastic and viscous responses.
`Now, the relevant record, which is the challenged
`patents, and Baugh, have not changed. Instead, as detailed in
`Petitioner's replies, Patent Owner proposes new constructions of
`hemostatic parameter and viscoelastic property, tailored from the
`selective citation of inconsistent and non-exhaustive lists of
`indices and of parameters from the specification.
`Recognizing these inconsistencies, Patent Owner adds
`extrinsic references to specialized tests, and in biofluidics
`academics, they spoke synthesis of other terms not even
`appearing in the specification into a convoluted substitute for the
`terms "hemostatic parameter" and "viscoelastic property."
`Putting up slide 10 again, Patent Owner's new
`construction for the hemostatic parameter limitation is on the
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`right side -- the right column of slide 10, and it includes a
`conjuring of new elements not recited in the claim or the
`specification, including requiring a measurement that relies on
`multiple components of hemostasis.
`And then slide 20, Patent Owner's new construction for
`the viscoelastic property limitation is on the right side, right
`column of slide 20, and again, it includes conjuring of new
`elements not recited in the claim or specifications, including
`requiring taking into account at least some metric of the viscous
`component and some metric of the elastic component to provide a
`characteristic of the test sample.
`As detailed in Petitioner's replies, this wholesale
`rewriting of the claims is impermissible. Patent Owner has not
`shown how the panel's application in the institution decisions of
`the claim terms is inconsistent with or unreasonable in view of
`the Viola specification, thus Patent Owner has not demonstrated
`that further construction is necessary or proper.
`With respect to the hemostatic parameter limitation,
`Patent Owner's newly proposed construction is impermissible
`under the BRI standard, and is inconsistent with the specification.
`Looking at slide 13. An ordinary reading of a parameter is a
`characteristic behavior of something, and a hemostatic parameter
`is a characteristic of some aspect of a hemostatic process. Patent
`Owner's proposed rewriting of hemostatic parameter to require
`multiple unspecified components of the process is not based on
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`ordinary meaning or even consistent special usage in the
`specifications, but simply posits that a hemostatic parameter
`means characterization of more than one component of the
`hemostasis process.
`Slide 14. Furthermore, shown on slide 14, Patent
`Owner's newly proposed construction of the hemostatic parameter
`limitation is inconsistent with the Viola specification. Viola states
`a general purpose of providing in vitro quantification of
`hemostatic dysfunction that may not necessarily include the full
`hemostatic process. The claims explicitly require that each
`individual chamber be configured to be interrogated to determine
`a hemostatic parameter.
`Viola does not, however, measure the complete
`hemostasis process, or even multiple components of the
`hemostasis process in each chamber. Rather, in some chambers,
`platelet activity is suppressed.
`So looking at slide 15. As shown in table 1 of Viola,
`reproduced on slide 15, example wells 2 and 3 include abciximab,
`inclusion of a platelet inhibitor such as abciximab results in an
`isolation of a specific component of hemostasis. Thus, as taught
`in Viola, determining a hemostasis parameter in each chamber
`does not require reliance on multiple components of hemostasis
`in each chamber.
`Looking at slide 23. Patent Owner's new constructions
`also fail because they are vague and unanchored to any relevant
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`basis or consistent terms in the Viola specification. For example,
`with respect to the viscoelastic property limitation, the term
`"metric" is not mentioned in the specification. And the term
`"account" occurs once in the specification in the context of
`proteins and not in the context of the metrics of viscosity or
`elasticity.
`And slide 18. Even were the panel to adopt the newly
`proposed constructions as set forth in the replies, Baugh's explicit
`description of its operation in column 9, lines 34 to 43, of the '971
`patent, and this is the first sentence of which is reproduced here
`on the screen on slide 18. This meets Patent Owner's proposed
`limitations. "As the plunger assembly 72 descends through the
`fluid it is resisted by a property of the fluid in the reaction
`chamber 94, such as the viscosity, which changes as a result of
`the onset or occurrence of a coagulation-related activity, e.g.,
`platelet activation and aggravation followed by coagulation
`resulting in fibrin formation.
`JUDGE KOKOSKI: Counsel, what other properties of
`the fluid could that be referring to in Baugh besides the viscosity?
`I mean, they call out viscosity, I see they use "such as," but is
`there something else that viscosity is measuring?
`MR. CHOW: Well, as stated in both -- both Baugh and
`in the testimony on cross examination of Petitioner's expert, the
`property is really the resistance to the force, resistance of plunger,
`or resistance to an acoustic measure. The viscosity is actually
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`backed out from those measurements. Both the viscosity and
`elasticity are backed out using -- in Viola it's using a model that's
`several models for using springs and dashpots. And in -- in
`Baugh, essentially the -- the plunger is resisted by forces that may
`be both viscosity and things that relate to viscoelastic property
`that is the -- the coagulation formed from the fibrin formation.
`So it's a combination of things that are ultimately split
`out into viscosity and elasticity, but it's the viscoelastic property.
`For example, when the plunger drops, eventually it stops, because
`enough fibrin is formed that a mesh is there. So these properties
`generally are related to the resistive force. So viscosity is one of
`the resistive forces.
`JUDGE ABRAHAM: How does this statement in
`column 9, though, relate to the description in Baugh that there's
`heparin?
`MR. CHOW: We can get to that as well, the -- heparin
`is not something that completely stops fibrin formation, it slows
`down fibrin formation. And there's testimony we have that
`addresses that, that eventually even in the Baugh test, there is
`fibrin formation. And this is what -- this intrinsic evidence says
`specifically that that's what happens in Baugh. Here it says the
`fibrin formation does occur, even if there's heparin.
`And that's -- you know, I think the panel got it correctly
`in the institution decision, that this is a process of the onset or
`occurrence of the coagulation-related activity. It may be slower,
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`but it nonetheless happens, and when it does completely happen,
`the plunger stops.
`So just to finish up here. So contrary to the Patent
`Owner's expert and consistent with the testimony of Petitioner's
`expert, and I can refer to the Mize deposition in Exhibit 2005,
`page 190, lines 2 to 16; page 199, 11 through page 221; and 208
`from line 23, through 211, line 13.
`Baugh explicitly discloses even in the presence of
`heparin, measurement of the property of coagulating blood,
`which is a viscoelastic material, and which includes fibrin
`formation, even if it's partly suppressed. Since fibrin is formed,
`multiple components of hemostasis, fibrin formation, and platelet
`activity are taking place. It is clear that the property measured by
`Baugh is the force resisting the fall of the dropped plunger, which
`changes with the coagulation-related activity, including fibrin
`formation.
`Such coagulation-related activity is agreed to
`characterize changes in the viscoelastic properties of the
`coagulating blood. Since the measurement takes place after the
`onset of coagulation related activity, as this panel saw, the plunger
`is necessarily resisted by both viscous and elastic forces of the
`coagulating blood. Thus, the teaching in Baugh that the sample is
`interrogated after the onset of coagulation-related activity,
`including fibrin formation, meets both Patent Owner's new
`constructions for determining hemostatic parameter, in measuring
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`multiple components of hemostasis, and for measuring
`viscoelastic property, as taking into account some metric of both
`viscosity and elasticity.
`JUDGE KALAN: And is this metric the same as you
`stated in your reply, you were saying that the metric, if we're
`looking at Patent Owner's proposed construction, is the resistive
`force?
`
`MR. CHOW: No, I -- the term "metric" doesn't appear
`in the Viola specification. What we can -- what we see that -- I
`think that what they're referring to is some metric that's backed
`out from using the model. So what the forces that are measured
`are the resistive forces, then using the model, they backed out
`things like indices -- I don't know what metrics. I mean, these --
`one could say that viscosity after it's been backed out is a metric,
`or that elasticity, if backed out, was a metric.
`And, in fact, Baugh meets the claim construction
`proposed because it shows a change in the viscoelastic property,
`that it's even the onset of viscoelastic properties is enough. So
`that's looking at the actual claim language rather than the
`rewritten claim language.
`Now, Patent Owner has served some 45 slides, largely
`reframing the arguments in their responses. I will address these
`in my rebuttal time -- address such of those arguments that Patent
`Owner presents to the panel today, but otherwise rely on the
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`petitions and the replies, which I think really set forth all the
`arguments necessary.
`Of course, I would be happy to answer any questions --
`further questions in my remaining time for this beginning 15
`minutes.
`JUDGE ABRAHAM: Any questions, Judge Kalan?
`JUDGE KALAN: No.
`JUDGE ABRAHAM: Judge Kokoski?
`JUDGE KOKOSKI: No.
`JUDGE ABRAHAM: I have you at about 18 minutes,
`you have about 12 left for your rebuttal.
`MR. CHOW: Okay.
`MR. NOLAN: May I proceed?
`JUDGE ABRAHAM: Absolutely.
`MR. NOLAN: Good afternoon, Board. Thank you for
`the time to speak to you today.
`A few points. Just one thing that is clear is that
`Petitioner wants to rely upon this Board's decision to institute,
`and that is under a different standard and now it has the burden of
`showing by preponderance of the evidence that these claims are
`not patentable.
`My opposing counsel referenced that the record has not
`changed. I would suggest to you that the record has changed
`dramatically. The Board did not have the opportunity to see all
`the admissions that Patent Owner was able to get from Dr. Mize,
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`did not have the opportunity to review the testimony of Dr.
`Diamond, and if you look at even the slide presentations, you'll
`see they're starkly different. Patent Owner's is grounded in
`evidence, Petitioner's is grounded in attorney argument.
`If you look through their reply declaration, their reply
`petition, it is all attorney argument. They did not put in a reply
`declaration to rebut any of the arguments that Patent Owner has
`presented, and they did not meaningfully cross examine Dr.
`Diamond on almost the entirety of his opinion.
`A perfect example of the absence of evidence is there
`was a statement that was made that said, "the plunger in Baugh
`stops because fibrin formation has continued so far to become a
`mesh." There is absolutely no support in Baugh, or in the
`testimony from Dr. Mize that that happens.
`When Baugh gets stopped is they have a predetermined
`time that it's going to take the plunger to drop. A predetermined
`viscosity that they're trying to measure. And when they get to
`that predetermined time that it takes Baugh for the plunger to
`drop, they say that's a clot time. It has no characterization of
`whether a clot is actually formed. Baugh is all about assessing
`platelet activity and platelet activation.
`JUDGE ABRAHAM: What about the portion in
`column 9 that talks about coagulation activity where there's
`platelet activation and aggregation followed by coagulation
`resulting in fibrin formation?
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`MR. NOLAN: Yes, and, Your Honor, I would suggest
`that I will take you through the concept of what happens in
`hemostasis, but fibrin formation is just the initial step. Fibrin
`formation is when fibrinogen is converted to fibrin. If you look at
`the evidence in the record, that fibrin then must polymerize and
`must cross-link, and the evidence that we have from Dr. Mize
`where he says, "the fibrin clot is necessary for hemostasis to
`occur," the evidence that we will -- I could show you in our
`slides, for example, in slide 9, of our exhibit, if you read the
`bottom, it says -- actually, if you look at the top, it says,
`"viscoelastic properties are among the most sensitive measures of
`fibrin polymerization. Fibrin polymerization is the second step
`after fibrin is formed, and then it can cross-link. Once it
`cross-links, it becomes this fibrin mesh that platelets can grab
`onto and can form the viscoelastic solid."
`And if you look at the bottom of this, the key point in
`the context of blood coagulation is that the blood clot is required
`to perform a hemostatic function and the properties of a
`viscoelastic solid are necessary. It's not till you get to the fibrin
`polymerization and the fibrin cross-linking and the platelets
`interacting with that that you get to a viscoelastic solid that can be
`measured.
`JUDGE ABRAHAM: Why are you saying that you
`don't get to a viscoelastic solid until you get this step that's shown
`here in your slide 9? Baugh is saying that there's coagulation,
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`that there's platelet activation and aggregation followed by
`coagulation. Why isn't that enough to say there's some sense of
`elasticity going on there?
`MR. NOLAN: Why isn't it enough? Because Baugh
`says that it's measuring the property of a fluid. A fluid is different
`than a viscoelastic solid. And so if you --
`JUDGE ABRAHAM: I agree, but there's testimony
`from both sides, and I think from your declarant, that says
`viscoelastic materials can be fluids.
`MR. NOLAN: But if you look at the evidence from Dr.
`Mize, he even says that there is -- what we're talking about, if you
`look at slide 21 of our presentation, when we're asking him, when
`we're talking about the aspect of viscoelastic property, what are
`we trying to measure? It says, "And when we talk about
`viscoelastic properties related to hemostasis, are we talking about
`properties associated with the blood clotting that occurs during
`hemostasis?" And it says, "Yes."
`If you have blood clotting, you're not measuring the
`property of a fluid, because a clot is not a fluid. So he even
`acknowledges, Dr. Mize, at this testimony in Exhibit 2005, page
`90, 9 to 19, he says, "it has to be a fluid."
`He also acknowledges on our slide 25 that talking about
`Baugh, "but there is nothing in this patent that talks about
`viscoelasticity, correct, sir?
`"That's true."
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`And it says that the property is what -- the property is
`what alters the speed of the plunger as it goes through the fluid
`sample; right?
`"Yes.
`"And that's what it's described as the fluid sample,
`correct, sir?
`"Yes."
`So their own expert acknowledges, Baugh doesn't talk
`about viscoelasticity, Baugh is always talking about a fluid being
`measured, and from this they want to extrapolate, well, there may
`be some viscoelastic material in it, but if you look at what Baugh
`says, if you look at what it's trying to do, it says that it has to
`foreclose the latter half of the coagulation cascade. It needs to do
`that because it wants to measure the concept of what platelets are
`doing.
`
`And so if I could direct you to -- if you just give me one
`moment. Slide 21. Excuse me, so, if slide 21 takes us to the '971,
`and you see the '971 is distinguishing between there is a viscous
`fluid state, similar to what Baugh has at the initiation. It says, as
`coagulation activity and fibrin is cross-linked into fibrin strands,
`it behaves as a viscoelastic solid. And then when the fibrin mesh
`is destroyed, or the fibrinolysis happens, it becomes a viscous
`fluid.
`
`That is consistent with what Baugh is saying, because
`when you look at Baugh, Baugh always says it's a fluid, and then
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`Baugh tells you, heparin is necessary to inhibit reactions which
`occur later in the coagulation cascade, or process, and that
`includes factor 10 activating the factor 10A, that includes
`prothrombin, that includes fibrinogen.
`If I can take you to slide 11 of Patent Owner's
`presentation, this is the coagulation cascade. So, you have
`platelets are activated, and Baugh is looking at the top left. It
`wants to see what happens with activated platelets, it wants to see
`what happens when they -- they accumulate and they aggregate.
`And, in fact, what it really wants to see is it wants to see what
`type of medicine, how much medicine or how much of a
`compound you need to prevent that aggregation. But when we
`have heparin in, we inhibit the latter half. That's what Baugh is
`telling us to do. It's telling us, inhibit 10 from activating the 10A.
`It tells us, inhibit prothrombin and thrombin. And thrombin is
`required to turn the fibrin -- fibrinogen into fibrin. And when you
`inhibit all that stuff, what happens? You don't get the stabilized
`cross-linked fibrin clot.
`And their expert acknowledges, hemostasis requires that
`fibrin clot, that viscoelastic clot. And so that's why --
`JUDGE ABRAHAM: But Baugh is measuring
`something, right? It's putting the plunger into the chamber and
`it's measuring something. Wouldn't you agree with that?
`MR. NOLAN: It measures something, but by the same
`token, if I have to measure the area of a rectangle, if I measure
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`the width, does that tell me anything about the area of the
`rectangle? No, I need to understand something about the width,
`and something about the length. And when we're talking about a
`device that can interrogate for a viscoelastic property, I need to
`understand at least something about both components.
`JUDGE ABRAHAM: All right, well, I guess let me go
`back to my first question, because I wasn't quite finished. So
`Baugh is measuring something, I guess my question is, what is it
`measuring? What's happening to that viscous fluid that you say is
`just a fluid, what's happening in that fluid that's providing
`resistance to the plunger?
`MR. NOLAN: And, yeah, you can see, and we talk
`about this on Dr. Diamond exhibit, 2006, I believe, paragraph
`106, but what it's measuring is as these platelets aggregate. So
`platelets are in the blood, and then when they -- when they add in
`an activator, that activator will start the coagulation cascade.
`With the activator that's added, they're also adding in an inhibitor
`or the heparin, an anticoagulant to shut off the bottom half. What
`it's doing is it's causing the activated platelets at the top to start to
`accumulate.
`JUDGE ABRAHAM: What form -- what state of
`matter is that in? Is that a solid?
`MR. NOLAN: It's a solid, but it's not a viscoelastic
`
`solid.
`
`JUDGE ABRAHAM: Why not?
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`MR. NOLAN: Because platelets are not viscoelastic.
`And if you go back to what we were talking about in the
`beginning, on slide 8, the fibrin is the key to viscoelasticity of the
`clot.
`
`JUDGE ABRAHAM: So what is a viscoelastic
`property? The claim says measuring -- I think it's a viscoelastic
`property, which seems to imply that there's more than one
`viscoelastic property that could be measured. Can you give me
`some examples of viscoelastic properties that can be measured?
`MR. NOLAN: Yes. In this patent, what it talks about,
`which is a viscoelastic property, is examples such as TC1, which
`is the coagulation time for formation of fibrin and platelets to
`begin to come together. It talks about TC2, and that stops. It
`talks about clot stiffness S, and the stiffness is clearly a
`viscoelastic property because it takes into the account the viscous
`nature of the blood clot, it takes into account the elastic nature of
`the blood clot to determine a stiffness of that material.
`JUDGE ABRAHAM: Where does it say that those are
`the viscoelastic properties? I thought those were the hemostatic
`parameters you were talking about?
`MR. NOLAN: Well, if you -- if I may, Your Honor,
`when it talks about on column 16, it talks about how it determines
`the viscoelastic properties, and carrying over to column 17 where
`it talks about using the Voigt-Kelvin to characterize the
`viscoelastic properties. And if you look at column 17, starting at
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