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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ABS GLOBAL, INC.,
`Petitioner,
`
`v.
`
`CYTONOME/ST, LLC,
`Patent Owner.
`____________
`
`Case IPR2017-02097 (Patent 8,529,161 B2)
`Case IPR2017-02162 (Patent 9,446,912 B2)
`____________
`
`Record of Oral Hearing
`Held: January 9, 2019
`___________
`
`
`
`
`Before SCOTT A. DANIELS, BEVERLY M. BUNTING, and
`TIMOTHY J. GOODSON, Administrative Patent Judges.
`
`
`
`
`
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`
`
`
`
`
`
`Case IPR2017-02097 (Patent 8,529,161 B2)
`Case IPR2017-02162 (Patent 9,446,912 B2)
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`JEFFREY P. KUSHAN, ESQUIRE
`FITZ B. COLLINGS, ESQUIRE
`Sidley Austin, LLP
`1501 K STREET, N.W.
`Washington, D.C. 20005
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`THOMAS W. LANDERS, IV, ESQUIRE
`Akin Gump Strauss Hauer & Feld, LLP
`1111 Louisiana Street, 44th Floor
`Houston, Texas 77002-5200
`
`and
`
`DANIEL L. MOFFETT, ESQUIRE
`Akin Gump Strauss Hauer & Feld, LLP
`112 East Pecan Street, Suite 1010
`San Antonio, Texas 78205-1512
`
`
`
`
`The above-entitled matter came on for hearing on Wednesday, January
`
`9, 2019, commencing at 9:59 a.m., at the Silicon Valley U.S. Patent &
`Trademark Office, 26 S 4th Street, San Jose, California, 95112.
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`Case IPR2017-02097 (Patent 8,529,161 B2)
`Case IPR2017-02162 (Patent 9,446,912 B2)
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`
`P R O C E E D I N G S
`- - - - -
` JUDGE GOODSON: Good morning, and welcome to the
`Patent Trial and Appeal Board.
` This is the hearing for two proceedings between
`petitioner ABS Global, Inc. and patent owner Cytonome/ST,
`LLC.
` Case IPR2017-02097, involving patent
`number 8,529,161, and case IPR2017-02162, involving patent
`number 9,446,912.
` I'm Judge Goodson, and Judges Daniels and Bunting
` are appearing remotely by video link. You can see them on the
` screen up here.
` Judge Daniels, are you able to see and hear us?
` JUDGE DANIELS: I can hear you just fine. How about
`me?
` JUDGE GOODSON: Great.
` Judge Bunting?
` JUDGE BUNTING: Yes, I can see and hear you both.
` JUDGE GOODSON: Great. Okay.
` Let's have counsel introduce themselves, starting
`with counsel for petitioner, please.
` MR. KUSHAN: Good morning, Your Honor. Jeff Kushan
`from Sidley Austin on behalf of petitioner. And with me is
`Fitz Collings, also with Sidley Austin.
` JUDGE GOODSON: Thank you. And Mr. Kushan, are you
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`going to be doing the presentation today?
` MR. KUSHAN: So today I'll be doing the presentation
`on the '161 patent, and Mr. Collings will be handling the
`argument on the '912 patent.
` JUDGE GOODSON: Okay. And who do we have for patent
`owner?
` MR. MOFFETT: Good morning, Your Honors. Daniel
`Moffett with the law firm Akin Gump, here on behalf of patent
`owner. With me is Thomas Landers with the same firm.
` We're going to do a similar split; I'll be arguing
`with respect to the '161, and Mr. Landers will be arguing
`with respect to the '912.
` JUDGE GOODSON: Great.
` Okay. By way of reminder, because Judges Daniels
` and Bunting are participating remotely, please indicate the
` slide number or page number from the record that you're
` referring to during your presentations so that they can
` follow along easily.
` The Trial Hearing Order of November 14th sets out
` the procedures that we'll follow today. Each party has 60
` minutes total for its arguments addressing both the 2097 and
` the 2162 IPRs. The parties can allocate their time between
` the cases as they choose.
` Would the petitioner like to reserve any of its time
` for rebuttal?
` MR. KUSHAN: Yes, Your Honor. We'd like to reserve
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`15 minutes for rebuttal.
` JUDGE GOODSON: Okay. And patent owner?
` MR. MOFFETT: Your Honor, if we do get into our
`motion to exclude, we would want to reserve one minute. I
`think that would depend on -- on the arguments presented.
` JUDGE GOODSON: Okay. All right. With that, we'll
`turn it over to -- to you, Mr. Kushan. You can just begin
`whenever you're ready.
` JUDGE DANIELS: Judge Goodson -- oh, thank you. I
`was just going to say, I needed a -- as much as it's nice to
`see you, I couldn’t see the attorneys, which I now can.
`Thank you.
` MR. KUSHAN: Thank you, Your Honors.
` As I mentioned, I'll be covering the proceeding
`involving the '161 patent. In that, the '097 proceeding, you
`found that we met our burden to establish anticipation of
`Claims 1, 4, 8, 9, 12, 16 to 20 over Wada, but that we did
`not meet our burden to do so for anticipation for Claims 2 to
`3, 5 to 7, 10 to 11, and 13 to 15. You also -- you found
`that we did not meet our burden on obviousness for all the
`claims.
` At a high level, the disputes in this proceeding
` focus on whether the claims require or don't require certain
` things, and really focus on what is going on with the Wada
` system. So that's my -- I'm going to start with the claims
` and then deal with Wada.
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` Claims 1 and 9 -- if you could put up Slide 3.
` Claims 1 and 9 are the independent claims. They're
` parallel. One is an apparatus, one is a method.
` You can see that they use open language
` "comprising". So microfluidic device comprising.
` Then there is a primary flow channel. That's the
` first element.
` There are then two adjustments regions within the
` primary flow channel; an upstream and a downstream.
` The adjustments, as the claim specifier made, by
` adding more suspension medium via an inlet that intersects
` the primary flow channel. And it's important to note that
` no other structural features of the flow channel is really
` focused on the added sheath fluid.
` The second region has to adjust the sample in a
` direction that's opposite of the direction that the sample's
` adjusted in the first region.
` It's also important to recognize, when they speak of
` sample, the claims actually tell you what that is. It's a
` sample that comprises of at least one particle. That's what
` the language of the claim states.
` And there's also no other attribute defined in the
` claims for the identity of the sample. So it could be
` 100 percent of one kind of particle, they could be mixed
` particles, it doesn't matter. That's the claim breadth.
` Now, the first dispute centers on the term
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` "adjusting", and we believe, in your Institution decision,
` you've correctly found that adjusting means "to move".
` That's the --
` JUDGE DANIELS: Counsel, let me --
` MR. KUSHAN: Yes.
` JUDGE DANIELS: -- let me interrupt you for just a
`second before we leave -- before we totally leave your
`Slide 3.
` MR. KUSHAN: Mm-hmm.
` JUDGE DANIELS: I know the claims are fairly similar
`here across -- across the patents to an extent.
` And they're interesting because we currently have a
`method claim here that's Claim 9. And -- in the '161 patent
`I'm talking about -- and we also have Claim 1, which is a
`system.
` The system claim here, though, seems to sort of be a
`combination of method and apparatus claims as opposed to a
`straight-up apparatus claim.
` Is there something that we should be considering
`here as far as the functional language being more limiting
`here than perhaps it might be in the '912 patent?
` I just wanted to make sure that -- but that we
`were -- when we look at these claims, we sort of know what
`we're looking at and why they're different.
` MR. KUSHAN: So that's a good question, Your Honor.
` What you see in the device or the system claim here
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` is essentially a functional attribute of each element. So
` the element has to presumably do or deliver that functional
` capability.
` There's nothing beyond the introduction of the
` additional suspension fluid that they identify in the claim
` language to achieve that function. And that's important
` because there are a lot of parameters about these devices
` that influence how they behave, such as their geometry, the
` parameters of flow, things like that. None of those
` parameters are set forth in the claim, they just go to
` the -- kind of the bottom line of what all of those
` parameters might deliver as a functional result.
` And that's important because it means those
` claims -- that system claim is very broad in its
` characteristics about what it covers between its comprising
` language and because of that functionally defined character
` of the elements. It's a very broad claim.
` And I don't think -- when you selected Claim 1 as a
` representative claim, we agree with that because there's no
` real consequence, there's no -- I don't know if the parties
` have identified any practical consequence between Claim 9
` and Claim 1 relative to its comparison to the prior art or
` meaning.
` JUDGE DANIELS: So Claim 1 here then -- it sounds
`like what you're saying is Claim 1 is more along the lines of
`apparatus claim and that these -- although I --
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` Let me back up and ask this question.
` MR. KUSHAN: Sure.
` JUDGE DANIELS: We agree that functional language
`can be a limitation in certain cases -- whether or not it is
`here or not we can decide later, but --
` MR. KUSHAN: I mean, at least conceptually, if
`function compels a configuration, then that, I think you
`could argue, would -- within the context of the meaning and
`interpretation of the claims, particularly in a court setting
`could give meaning to the attribute that you're speaking of.
` This is still under the broadest reasonable
`interpretation standard, and for a number of these elements,
`there is no real dispute about whether there is something
`adding in from either preamble or context and intended use,
`prosecution history has only relevance to one question about
`focusing, and we have a dispute about that, but I think this
`is kind of a classical instance of a very broadly
`characterized apparatus that has defined its elements in
`functional terms, meaning they cover essentially anything
`that would deliver that functional outcome.
` Does that answer your question?
` JUDGE DANIELS: So you would argue -- so you would
`argue that in the system claim, that the functional language
`here does not dictate or compel, I think was the word you
`used, the structural arrangement of the system.
` MR. KUSHAN: Correct. And there are a couple
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`specific elements that I'll focus on to get into that in a
`minute. And maybe I can -- I can dive into that, and if you
`have questions, I'm happy to tease that out further.
` JUDGE DANIELS: No. Just keep going with what
`you're doing. I just wanted to -- just to thank you. That
`was helpful to understanding your position on the -- in this
`Claim 1. Thanks.
` MR. KUSHAN: Okay. So the first dispute is focusing
`on this adjusting language in the independent claims. And
`you found that meant to move the sample in a particular
`direction, and we feel like that is the most logical reading
`of the claim.
` First, there's no preamble as I mentioned, there's
`no kind of context that is infused by some preambular
`language for this device claim.
` Second, there isn't any prosecution history that's
`been alleged to influence what it means relating to these
`claims.
` So -- and if -- the third thing is just, when you
` look at this in the context with the dependent claims, this
` language "adjust" has to accomplish a variety of actions
` which, in -- at their heart, involve moving the particle or
` the sample. So we think your construction here was correct.
` And patent owner doesn't really raise any prior art
` issues. All of their arguments are around claim
` construction. So we think your finding of anticipation of
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` these claims was correct based on your interpretation of
` "adjusting".
` Just a couple of points on what our -- what patent
` owner has said about these claims.
` Patent owner argues that one aspect of adjusting
` means that you have to use essentially a sample which has a
` particular character, such as it either has a multiplicity
` of particles, and that you're acting on all of the particles
` in the sample, or that its position has a characteristic
` within the sample layer of the device that it's flowing.
` Those all kind of fall away when you appreciate that
` a sample can consist of a single particle.
` The language of the claims controls what the claims
` cover here, and without any other limiting attribute, it's
` really improper to read these kind of requirements into the
` claim.
` JUDGE GOODSON: So the sample can be one particle,
`but in the instance when the sample is more than one
`particle, how do we know that simply moving one of the
`particles is sufficient to have moved the sample?
` MR. KUSHAN: Well, the way to think about it is that
`the particles in these kind of microfluidic systems are not
`moving kind of independently of the two streams that are --
`that constitute the laminar flow. You have a sample stream,
`and then the particle is going to move with the sample stream
`based on what kind of flow you're creating.
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` So when we're speaking of a sample, it's really
` focusing on the movement of that sample layer which contains
` the particles in it, and then that, of course, the particles
` can change their position within that sample layer as it's
` moving through the device.
` Now, I also noted that the claims are comprising
` claims. So that means you can have elements that are not
` recited, such as if you look at our primary case with Wada,
` we used an illustration of a device in Figure 3 that has two
` regions that are focusing regions, and then has also a thing
` called a collection unit which is where the cells or
` particles end up. That is captured by the claim language,
` even though that's not part of the focusing -- you know,
` those collecting units are not part of the focusing regions.
` It's also important to recognize that there's no
` reason for doing these steps recited in the claim. So
` particularly for the system claim, these are just a -- this
` is a device that can be used for any kind of focusing or
` preparation of a sample.
` And there's no basis for reading things such as
` patent owner proposes, that you have to kind of end up after
` this to adjustment device with a sample that's ready for
` focusing, or particularly aligned or prepared for focusing.
` There's no focusing requirement -- I'm sorry -- there's no
` sorting requirement in the claims.
` And, in fact, at page 16 of their patent owner
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` response, the patent owners emphasize that, "The invention
` does not claim any sorting or detecting mechanisms or
` methods." So to read a requirement that this all has to be
` done to prepare a sample for sorting seems to be at odds
` with both the language and also how they represent their
` claims.
` JUDGE DANIELS: Counsel, can I -- can we jump -- can
`you just jump real quickly, because we're starting to talk
`about sorting --
` MR. KUSHAN: Yes.
` JUDGE DANIELS: -- to your -- your Slide 20 -- let's
`just go to 23. I think you talk about this -- I wanted to
`just make sure that the panel -- we were discussing this
`during or conference -- that there appears to be -- and you
`may be getting to this at some point, but I wanted to ask
`about -- there seems to be a dispute between testimony from
`Dr. Kapur -- if I'm saying that right -- and Dr. DiCarlo with
`respect to this sorting aspect, which is, I think, what
`you -- what you're talking about now.
` And I want to make sure I understand both parties
` and both of the experts, the declarants here. And if I'm
` understanding it correctly, your position is that the
` sorting that's going on here does -- that these particles,
` whether it's one or many, would remain in a -- they remain
` in their -- I guess their core flow, they are not pushed out
` into a sheath fluid, and that they remain that way until
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` they are finally sorted, I guess.
` Is that a -- if you can explain it better, please
` do.
` MR. KUSHAN: Sure. I'd be happy to.
` That is -- you had it generally correct. The thing
` you were -- the words I think you were looking for were the
` "laminar flow". And laminar flow is a particular type of
` flow that occurs in a microfluidic device where you have
` such as in Figure 23, you have a primary flow channel, which
` is 2300, that's where the sample starts, it comes in that
` sample layer, and then you're introducing sheath fluid in
` these two inlets, 2302 and 20 -- that are both set one after
` the other.
` When you introduced sheath fluid into a microfluidic
` structure in this manner, what you do is you envelope the
` sample fluid with the sheath fluid. That phenomenon creates
` something called laminar flow where you keep the two layers
` segregated. The particles are in the sample layer, and they
` won't leave the sample until the two layers ultimately mix
` together in the collection unit 2312.
` We know that that is true because, until you get
` into a configuration where you're no longer -- the
` structure, the geometry of the channel plus the movement of
` the fluids maintains laminar flow, they're going to stay in
` their own layers.
` You have the laminar flow means sheath fluid on the
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` outside, it's moving faster than the layer that's the sample
` layer. And that phenomenon of faster outside, slower
` inside, exerting force on the sample layer, that a force is
` what causes the sample layer to constrict, narrow, and
` focus. And that ultimately is going to stay intact, it's
` not going to change until you change the geometry, which
` occurs not until 2310, which is the -- or 2312 where you see
` the collection unit.
` Now, we know that Dr. DiCarlo and Dr. Kapur disagree
` about what's happening. I think part of it stems -- kind of
` two reasons that I can see. One is, what is it that we are
` representing are the two adjustment regions? And we've been
` very clear that the two adjustment regions are the two that
` we've highlighted in the two colors; blue and green. You
` see we don't label the 2312 or 2310 region as part of the
` adjustment region.
` The claims, as you know, comprise of claims, they
` only require the two adjustment regions, and that maps to
` those two colors.
` Within the two colored regions, you have a fixed
` structure. The 2300 is the primary flow channel. You have
` the same design, 2302, those two inlets are -- that's the
` same structure and process of introducing sheath fluid at
` each place.
` You found that 2302, in the first instance in blue,
` does cause focusing, and that's consistent with the physics
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` of how this works. And it also is happening in the second
` region because the same thing is happening; you're
` introducing the sheath flow at a higher rate, and it's
` further refining, further focusing the sheath fluid
` JUDGE DANIELS: Dr. Kapur's testimony in his
`declaration had some -- and I'm sure patent owner will
`address this when it's his turn -- but there is some -- you
`know, I found it to be interesting, and credible to some
`extent, that it seemed like, if you pulse in the second
`region, if you're pulsing in a sheath fluid to sort these,
`that it would knock them to one side or the other and out of
`the sheath fluid, or out of its core, the core flow. So --
`but you're --
` But DiCarlo's testimony is the opposite saying that
`it does not do that, it just forces the core to one side or
`the other.
` MR. KUSHAN: Yeah. So -- and we actually provided
`additional evidence during the proceeding to help demonstrate
`that laminar flow is being maintained -- and you should
`really think about this -- is laminar flow being maintained,
`are the two layers being maintained as separate layers, or
`are they mixing?
` You're going -- the phenomenon that Dr. Kapur is
`referring to would happen if there were not maintenance of
`the laminar flow. You need something that's going to disrupt
`or get the particles out of that interior layer.
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` I like to think of this as like a garden hose, if
`you can imagine it, in the green area, it's the garden hose
`is tilting one way or the other where the exterior of the
`hose is the sheath layer and the interior is the sample
`layer. It's not going to punch a hole through the walls of
`the garden hose particularly because of the geometry and the
`physics of a microfluidic structure.
` Now, there's a way --
` JUDGE GOODSON: You're saying that laminar flow is
`maintained throughout both the blue and the green regions as
`we look at it in Slide 23?
` MR. KUSHAN: That is correct, Your Honor.
` And we -- in our reply, Dr. DiCarlo -- there's
`actually ways of knowing whether laminar flow is being
`preserved. When we saw Dr. Kapur allege that laminar flow is
`not being maintained and that these things were mixing in
`this region, Dr. DiCarlo did the math. He basically went and
`analyzed the flow structure, he analyzed the parameters of
`the flow that's being described in Wada, and he found that
`it's maintaining laminar flow.
` He cites in particular in paragraph 73 of his reply
`declaration, he gives an explanation of why laminar flow is
`being maintained. That's also reflected in paragraph 65 of
`his declaration. He explains that this is -- the laminar
`flow is causing that -- a sample layer to get compressed and
`narrowed.
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`Case IPR2017-02097 (Patent 8,529,161 B2)
`Case IPR2017-02162 (Patent 9,446,912 B2)
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` He also gave his scientific basis for that
`conclusion at paragraphs 82 to 84 of his report as applied to
`Wada where he walks through what's happening in each of these
`two regions.
` He points out in the first region, you have a
`certain amount of compression caused by the focusing that
`occurs there of the sample layer, and then you have
`additional focusing of that sample layer where the additional
`added sheath fluid is flowing in.
` There's a principle of conservation of mass which is
`why this happens. You have a fixed amount of space, you have
`a certain amount of space occupied by the fluid, you add
`fluid, it's going to compress the interior fluid. You can't
`lose mass.
` What that does is two things. One, it makes it
`smaller, makes the sample layer smaller, but it also is going
`to accelerate both the interior and the exterior fluids, the
`sheath (inaudible), in this configuration (inaudible).
` That's also going to naturally cause an alignment of
`the particles within that sample layer because the sample
`layer is now smaller and there's just less space for the
`particles to move around in.
` Now, Dr. DiCarlo also did some math. There's a
` techniques or a factor called the Reynolds number. That's
` calculations that can be performed when you analyze the flow
` structure and look at all the parameters, and if you have a
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` number that's below 2000, it indicates that laminar flow is
` present. If it's above, then you've lost laminar flow.
` What Dr. DiCarlo calculated was that the laminar
` flow for the blue region was around 230, and the laminar
` flow -- which you can go to Slide 28, please. This is his
` explanation for the calculation on the first blue region.
` And then Slide 29, he calculated the Reynolds number
` for the green region to be 455, well blow that laminar flow
` threshold.
` So we believe, as you sit here now, there is a
` fairly robust amount of evidence in front of you to
` demonstrate that what Dr. DiCarlo said is happening in the
` blue and green regions is actually true.
` There is a maintenance of laminar flow. The
` phenomenon that Dr. Kapur might have been referring to might
` have happened at the collection units, and some of his
` testimony seems a bit fuzzy at times about whether it's
` referring to the event occurring at the collection unit or
` upstream, but as a matter of science, it is not going to
` happen if you inject only fluid in the green region of the
` flow channel, that you will push the particles out of the
` laminar flow. That just won't happen. And we've
` demonstrated that and proven it with additional evidence.
` JUDGE GOODSON: So how is he able to calculate the
`Reynolds number for this figure? Is that based on the ratios
`that are shown in the figure?
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` MR. KUSHAN: I will confess, I'm not -- I can't tell
`you with a lot of detail, but what we had Dr. DiCarlo do was
`look at the parameters described in Wada, adopt very
`conservative estimates for the size of the channel, for the
`flow rates, things like that. Those are the numbers of the
`attributes that he needed to do the Reynolds number
`calculation.
` We had him do that in a fairly conservative manner,
`and he ended up with these numbers.
` He provided that in his reply declaration to support
`his original conclusion that laminar flow is being
`maintained. And what we -- there wasn't really testing of
`that by the other side.
` And I think it's fair to say, these are relatively
`well-established principles of microfluidic, so it's not
`surprising that there's not a dispute about whether there's
`laminar flow in the two regions.
` JUDGE GOODSON: Okay.
` JUDGE DANIELS: So we didn't have -- so what
`Dr. DiCarlo -- so he wasn't deposed on this?
` MR. KUSHAN: Dr. DiCarlo was deposed, but I don't
`think any of the testimony was -- detracted in any way from
`his analysis, they didn't show any defects in the analysis.
` And I don't think there's been anything really
`identified in our explanation of the design of these two
`regions that would suggest that the phenomenon that he
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`suggests is occurring is actually occurring. Those particles
`don't come out of a sample layer.
` JUDGE GOODSON: Was Dr. DiCarlo deposed after his
`second declaration?
` MR. KUSHAN: Yes. And they also had a surreply, as
`you'll recall.
` JUDGE DANIELS: And none of his testimony, from what
`I remember, none of his testimony in either of these cases is
`part of a motion to exclude, at least in this case. I think
`it's only the prior -- the litigation in the prior District
`Court litigation that's being excluded.
` MR. KUSHAN: I think there are objections to some of
`his testimony in one of his depositions, but, you know,
`patent owner counsel, I think, can address that.
` JUDGE DANIELS: Yup.
` MR. KUSHAN: Again, I think the proper way to think
`about this is that our expert analyzed Wada, found that
`laminar flow and focusing is occurring in both of those
`regions, explained his basis, we've presented that as our
`argument in our petition, and then they came forward and
`argued that it wasn't occurring.
` So this is a classic case where it's proper to put
`in a rebuttal to that assertion that the thing we said is
`happening is not, and then we provided our answers and
`explanations why that is -- why our expert was true.
` So what I'd like to do, and I want to be sensitive
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` to time, if I could go back for a moment to a claim
` construction issue around focusing. And the reason I want
` to do that is that we -- the Board instituted -- when they
` instituted (inaudible), they set forth kind of their own
` construction for focusing which took parts of each side's
` constructions.
` And I think we can -- we're comfortable with the
` general -- with most of the construction you adopted, but
` there are a couple terms that we think were not appropriate.
` Now, when you go into a classical process for claim
` construction of a term like "focusing", which is in only
` some of the claims, "focusing", you first found, was not
` defined to have a special meaning in the patent, and we
` agree. So you revert to the ordinary meaning of "focusing".
` The '161 patent gives a description of the device,
` which we think is consistent with that ordinary meaning as
` is shown in the prior art.
` If you go to Slide 8, please.
` Slide 8. This is just an excerpt, and it's just
` kind of illustrating what's happening in the device that is
` portrayed as the invention in the '161 patent. And you see
` the concepts of sheath fluid envelope and pinch a sample
` fluid that contains a number of particles, that flow sheath
` fluid containing particles, suspended, may be narrowed.
` That's the consequence of that higher speed, higher velocity
` sheath fluid exerting force on the sample layer.
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