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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`DEXCOM, INC.,
`Petitioner,
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`v.
`
`WAVEFORM TECHNOLOGIES, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01051
`Patent 7,529,574 B2
`____________
`
`Record of Oral Hearing
`Held: July 13, 2018
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`Before BENJAMIN D. M. WOOD, JON B. TORNQUIST, and
`ELIZABETH M. ROESEL, Administrative Patent Judges.
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`Case IPR2017-01051
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`MATTHEW W. JOHNSON, ESQ.
`Jones Day
`500 Grant Street, Suite 4500
`Pittsburgh, Pennsylvania 15219-2514
`
`CALVIN P. GRIFFITH, ESQ.
`Jones Day
`901 Lakeside Ave.
`Cleveland, Ohio 44114
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`SCOTT D. EADS, ESQ.
`NICHOLAS F. ALDRICH, JR., ESQ.
`KARRI K. BRADLEY, J.D., Ph.D., ESQ.
`Schwabe Williamson & Wyatt, P.C.
`Pacwest Center
`1211 Southwest 5th Avenue, Suite 1900
`Portland, Oregon 97204
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`
`
`The above-entitled matter came on for hearing on Friday, July 13,
`2018, commencing at 1:30 p.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
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`P R O C E E D I N G S
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`JUDGE ROESEL: Good afternoon, you may be seated. Give us
`just a minute here to set up.
`We will now hear argument in Case Number IPR2017-01051,
`Dexcom, Inc. versus WaveForm Technologies, Inc., concerning U.S. Patent
`Number 7,529,574.
`Counsel, please introduce yourselves, starting with Petitioner.
`MR. GRIFFITH: Your Honor, Calvin Griffith on behalf of the
`Petitioner Dexcom, Inc. With me is Matthew Johnson, who is also on the
`papers. Good afternoon. Thank you for the opportunity to be here.
`JUDGE ROESEL: Good afternoon.
`Patent Owner?
`MR. ALDRICH: Your Honor, Nika Aldrich of Schwabe
`Williamson & Wyatt on behalf of the Patent Owner, WaveForm
`Technologies, Inc. I am joined by Karri Bradley and Scott Eads is lead
`attorney on the case.
`JUDGE ROESEL: Thank you. So, according to our June 27th
`order, each party will have one hour to present its arguments today.
`Petitioner will argue first and may reserve rebuttal time, which may be used
`to respond to Patent Owner's arguments on issues for which Petitioner has
`the burden of persuasion. Patent Owner will argue second, and may also
`reserve rebuttal time and that rebuttal time can be used to respond to
`Petitioner's arguments on which Patent Owner bears the burden of
`persuasion.
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`The parties are reminded that this hearing is open to the public, and
`a full transcript of it will become part of the record. Patent Owner has filed
`objections to certain demonstratives of Petitioner, so the panel has
`considered these objections and they are overruled. The panel determines
`that path B, as used in Petitioner's slides, was fairly raised by the petition;
`for example, at page 52 of the petition.
`Each party may use its demonstratives as a visual aid in presenting
`its arguments; however, the demonstratives themselves will not become part
`of the record. To aid the court reporter in preparing the accurate transcript,
`counsel are requested to please identify the slide numbers as you present
`them. As a courtesy, counsel should please refrain from objecting during the
`other side's argument. Any objections can be raised during your own
`argument time.
`And with that, Petitioner may begin.
`MR. GRIFFITH: Your Honor, may I hand up a copy of our slide
`presentation for the Board? Would that be convenient, or we have a paper
`copy if you would find that helpful.
`JUDGE ROESEL: Yes, please. Thank you.
`MR. GRIFFITH: Sure.
`JUDGE ROESEL: Would you like to reserve rebuttal time,
`Petitioner?
`MR. GRIFFITH: I would, Your Honor. I intend to reserve 15
`minutes.
`JUDGE ROESEL: Okay. Hold on just one second, please.
`MR. GRIFFITH: Your Honor, Calvin Griffith on behalf of
`Petitioner Dexcom, Inc.
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`There are a number of grounds that are at issue today, both for the
`existing claims and for contingent amended claims. My comments and my
`opening remarks will be directed mostly to the first ground, Hagiwara 103,
`both as to the original claims and the contingent amended claims. And I
`expect to comment, nevertheless, on Wilson and some of the other
`references, but for the most part, I think my discussion is going to be largely
`Hagiwara-focused.
`The Hagiwara -- I'm on slide 4 -- the Hagiwara -- the combination
`of Hagiwara 1A and 1D renders all of the existing claims obvious. And one
`striking thing about this obviousness combination is that it involves a
`combination of embodiments in a single reference. So this case is a lot like
`the Boston Scientific case cited in the briefs and which I will come to later.
`Second, in regard to the Wilson grounds, first we will note that
`Wilson is not limited to Teflon insulation, but regardless, since that ground
`of unpatentability and the other related grounds with it were opened
`following the SAS decision, we've introduced evidence that shows that the
`member -- the cellulose acetate membrane does remain on the Teflon layer.
`And that's significant because that was the primary reason for not instituting
`on Wilson.
`And then third, as to the Patent Owner's contingent amended
`claims, they only add limitations that were well known in the prior art, as the
`Patent Owner admits. And, indeed, the specification states that those
`limitations are described in Wilson, which was issued 10 years before the
`'574 patent, and here, Hagiwara meets those added limitations by itself, or
`alternatively, in combination with references that disclose these well-known
`prior art features used for their intended prior art purposes and functions in
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`achieving predictable results. So this is a -- fits squarely within KSR and the
`contingent amended claims are unpatentable as well.
`Now, if I may go back to slide 3, briefly, this is Claim 1 of the '574
`patent. So about five million patents ago, this one issued, and like all other
`existing claims in the patent, Claim 1 is not specific to the analyte to be
`tested. It is not specific to the component or components or the number of
`layers to have in the membrane system, other than it has to have an enzyme
`in it, any enzyme. Not any particular enzyme. And it does not specify
`where the sensor is to be placed. It could be intravenously, it could be
`subcutaneously, or anyplace else, as long as it's indwelling. And again,
`these are points I'm going to come back to when we're discussing the Patent
`Owner's attempts to distinguish the claims over Hagiwara.
`Now, in the specification of the '574 patent, the actual invention is
`described as being the use of two nubs of dielectric material to support an
`enzyme layer. And the '574 patent accomplishes this with its annular nubs
`22, shown in blue in this reproduction of Figure 2 from the patent.
`Now, the patent states that because of nubs 22, a greater quantity
`of viscous fluid will adhere than would occur without the presence of nubs
`22, or they're also called plates 22. The patent never describes that any
`improvement would occur without nubs 22 and if one just had dielectric 14
`on the sides of that sensing cavity, that sensing window. And that's
`significant because that -- what's brought us here today is the claim
`construction in co-pending litigation in District Court where the Patent
`Owner argued that nubs in the claim were not limited to nubs 22 or nubs
`within a sensing cavity, but rather extend to the -- the term "nubs" extends to
`dielectric on the sides of a sensing window.
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`And then we've depicted that structure sort of modifying Figure 2
`from the patent to remove the blue nubs 22 and to show just the dielectric on
`the sides with a sensing cavity within it.
`JUDGE ROESEL: Counsel, here on slide 6, you use the term
`"plate nubs" 22. Does Petitioner agree that the term "plate" has a narrower
`meaning than the term "nubs" in the '574 patent?
`MR. GRIFFITH: We do, Your Honor. Yes.
`JUDGE ROESEL: So does Petitioner agree with Patent Owner's
`claim construction for the term "plate" as being a flat disk-shaped object that
`is wider in its diameter than it is thick?
`MR. GRIFFITH: That is not the way we construed it, but if this
`Court were to construe the -- the plates to be so limited, that would be
`consistent with the nubs 22 shown in the figure. Now, I don't think the
`specification is so clear on that claim construction point, and so I think under
`BRI, one would ordinarily construe it more broadly than that, but if the
`claim is so limited, and so for the nubs that are within the cavity, they have
`to be a plate-like structure that Your Honor described, that would have an
`impact, I think, on some of the validity issues in this case. Some of the
`unpatentability issues. But we don't -- for the purposes of this proceeding,
`we have not construed the term as narrowly as the Patent Owner has.
`JUDGE ROESEL: But the Petitioner does not oppose that
`construction, the one proposed by Patent Owner?
`MR. GRIFFITH: I would say we don't oppose it vigorously, Your
`Honor, yes.
`Now, as the Court can see from Figure 6 -- I'm sorry, slide 6, the
`accusation against our accused project involves some -- something that
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`doesn't have plates as nubs and it doesn't have certainly anything in the
`nature of nubs within the sensing window. It only has dielectric at the sides
`of the sensing window. If contended that meets the limitations of this claim
`of nubs, and as I said, that's essentially how we wound up here, because that
`makes prior art such as Wilson and -- and I'm on to slide 7 -- prior art such
`as Hagiwara and Wilson relevant, even though neither has nubs 22 within a
`sensing cavity.
`So like Dexcom's accused product, they have a cavity with
`insulating material, dielectric material on either side of the cavity, but they
`don't have those nubs 22 that are the sole source of the asserted
`improvement brought about by the '574 invention. So this broadened claim
`scope encompasses the prior art.
`I'm on to slide 8, which shows some illustrations from Hagiwara,
`and Hagiwara is a strong showing that the '574 claims contain nothing
`inventive when the claims are construed as they are in this IPR proceeding.
`Hagiwara shows one embodiment, 1D, in which a membrane system that
`includes an enzyme layer extends over a sensor cavity, or electrochemically
`active region, and on to the insulation at the end of the sensor wire. It
`surrounds and covers the electrochemically active sensing window, and the
`dielectric or insulation material around that sensing window.
`There was nothing inventive about having a membrane system,
`including an enzyme, and this 1D embodiment includes an enzyme,
`surrounding a sensing window, and the insulation material around that
`window.
`JUDGE ROESEL: The Petitioner agrees that Hagiwara does not
`expressly disclose an enzyme layer surrounding nubs.
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`MR. GRIFFITH: Yes, Your Honor, we do, and that's -- you know,
`we're not asserting anticipation here. So one could call the structure in
`1D -- one could call the dielectric there a nub, but it's not plural, it's one, and
`it does project from the wire, but it's just one. And we're not asserting that
`that is an anticipation in any event.
`But Hagiwara also has another embodiment, 1A, in which a
`sensing wire has a side-facing sensing window. So side-facing sensing
`windows were well-known designs for sensing wires at the time of this
`patent, back in 2003. Hagiwara discloses them. And there was a sensing
`cavity with what are now defined as nubs at the side of that cavity. And that
`it has a membrane system that covers that electrochemically active cavity,
`and the dielectric around it, the nubs around it.
`Now, that membrane system doesn't have an enzyme in it, but
`structurally, it is the same structure that one sees in this broadened
`construction of Claim 1 that we're operating with. So there was nothing
`inventive back in 2003 of having a membrane system that surrounded both
`an electrochemically active reaction surface, and the insulation material or
`dielectric around that, the nubs on either side of that.
`JUDGE ROESEL: So stepping back, under a Graham v. Deere
`analysis, how would you characterize the difference between Hagiwara and
`the claim?
`MR. GRIFFITH: Hagiwara has everything in it except the
`enzyme. So Hagiwara 1A has everything in it except the enzyme. Equally,
`one could say Hagiwara 1D has everything in it except the side-facing
`sensor window with two nubs surrounding it. So you can look at it either
`way, but I think it's easiest, Your Honor, to think of it under Graham v. John
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`Deere, Hagiwara has everything except the enzyme in the membrane system
`that surrounds that cavity and the dielectric around it. It has nubs, it has a
`membrane system surrounding and covering the dielectric and the cavity, but
`that membrane system doesn't have enzyme in it.
`JUDGE ROESEL: Well, wouldn't it be more accurate to say, well,
`what's missing from Hagiwara is the enzyme layer surrounding the nubs?
`MR. GRIFFITH: Yes, and, Your Honor, one could put it that way,
`but the point is that structurally, this -- this structure in 1A is very, very
`similar to the Claim 1 structure of the '574 patent, in that, you know, the
`inclusion or noninclusion of the enzyme doesn't change the structure of that.
`It changes what you're sensing for. That's what it changes. It changes what
`you are sensing for. The analyte you are seeking. But the structure isn't any
`different.
`But yes, Your Honor, you could say that it lacks the
`enzyme-containing membrane system. It has a membrane system, it just
`doesn't have the enzyme in it. And if I could, Your Honor, I'm going to stick
`with Hagiwara and get into this a little bit further here.
`So I think Your Honor's question nicely dovetails with what I
`wanted to talk about in this next slide, which is slide 10. And that is
`Hagiwara path A that has been referred to somewhat as path A, and that's
`where we submit that it would have been obvious to modify Hagiwara's 1A
`design or combine it with 1A -- combine that with 1D, and starting with the
`1A design, it's a general design for a sensor wire with a side-facing sensor
`and two nubs around the window, and a membrane system -- it doesn't have
`an enzyme -- but a membrane system surrounding the window and the two
`nubs on adjacent either end.
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`Now, 1D is a design for a sensor wire with an end-facing sensor, it
`has an enzyme-containing membrane system, and it surrounds or covers not
`just the reaction surface, not just the platinum, but also the dielectric around
`that platinum surface. If you think of the end of a pencil, before it's been
`sharpened, so the wood at the end of the pencil would be the dielectric. It
`covers that whole end, and then it covers further down onto the rest of the
`pencil, to the rest of the dielectric.
`And what we're saying is, it would have been obvious to use an
`enzyme-coating membrane system from 1D in the 1A sensor. If you could
`imagine taking that membrane system that you see in 1D and putting it on
`top of the 1A sensor, you have what is described in Claim 1 and the other
`original claims.
`Now, you could look at it either way, and I'm not going to get into
`path B so much today, just for the time that I have, I think it's easier to focus
`on the path A, but you could look at it as start with the 1D sensor, and
`modify it to have a side-facing sensor, and the motivation to do that is the
`side-facing sensor would have a reduced risk of damage and that sort of
`thing in use, when inserting or in use.
`JUDGE ROESEL: Well, counsel, I'm concerned that path A
`doesn't accurately reflect the difference between Hagiwara and the claim,
`because path A, you're focusing on motivation to combine the enzyme with
`Figure 1A, but the enzyme is not the end of the story, because you need the
`enzyme layer to surround the nubs to get to the claimed invention, right?
`MR. GRIFFITH: Correct.
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`JUDGE ROESEL: And if you focus solely on the motivation to
`include an enzyme layer, you're not addressing motivation to combine the
`enzyme layer such that it surrounds the nubs.
`MR. GRIFFITH: And let's talk about that, Your Honor. In that
`regard, so the ultimate question here is would it have been obvious to
`combine these two things, and let me go back to 1A, and we'll just follow
`the logic and go through the steps here. And I think there's a very strong
`logic and step-wise explanation really from Hagiwara how to get the 1A
`sensor to have an enzyme in it.
`So, again, we're here at the Figure 1A sensor, the side-facing
`window. It's one of the three generic designs that are described in Hagiwara
`to use to sensitize oxidizing substances or reducing substances. So with the
`glucose, you're creating a reducing substance, hydrogen peroxide. And it
`has the side-facing window, it has the cavity, it has the nubs, it has the
`membrane system that surrounds all of those things.
`So as I said before, Figure 1A has all of the structure that's
`described in the claim, except it doesn't have the enzyme layer. And that's
`why we're not arguing anticipation. But adding an enzyme to this membrane
`system would have been obvious, there was a motivation to do it, and
`Hagiwara -- you know, was there a motivation to do that and result in a
`structure that has, as Your Honor said, an enzyme layer surrounding the
`nubs.
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`Hagiwara answers that question with a robust disclosure of the
`benefits of enzymes to expand the functionality of this sensor.
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`JUDGE ROESEL: Yeah, I don't doubt that, but I think that, you
`know, is there something in the record about a motivation to combine the
`side sensor window with an enzyme layer?
`MR. GRIFFITH: Yes. Yes.
`JUDGE ROESEL: What is that?
`MR. GRIFFITH: Page 3 of Hagiwara, most notably. So this is on
`slide 14, page 3 of Hagiwara sets forth general information about how to
`tailor sensing electrodes to measure the substance of interest. It describes
`the bias voltage for sensing oxygen or for sensing hydrogen. So reducing
`substances or oxidizing substances.
`It also explains that such sensing electrodes can be used to measure
`substances other than oxygen or hydrogen. So it's saying, you can use these
`sensors to measure things not just hydrogen, not just oxygen, but other
`analytes, and it explains that the concentrations of substances that can be
`measured using an enzyme layer, using an enzyme layer among the fourth
`bullet here, on the reaction surface, should be on the reaction surface and in
`the vicinity of the reaction surface. So on the reaction surface and on the
`dielectric around it.
`And it describes, for example, that glucose concentration can be
`measured with an enzyme layer, namely glucose oxidase, and it gives
`examples of other substances -- other analytes that you could -- and enzymes
`you could use, ascorbic acid, uric acid, that sort of thing.
`Now, this description of what can be detected by the polarography
`sensors of Hagiwara is generic. It is not specific to 1A, 1B or 1C. Now,
`there is no statement -- there is no statement in this reference that the sensing
`of analytes other than oxygen or hydrogen can only be done using an
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`end-facing sensor cavity or window, not with a side-facing sensor cavity or
`window.
`Now, we have further detail, again, this is from page 3 of
`Hagiwara, about detecting glucose. It explains details about the reaction, the
`glucose oxidase reaction. It emphasizes -- and again, this is not specific to
`whether you're using side-facing sensor or end-facing sensor, it explains that
`you could fix the enzyme on the active surface of the sensing window and in
`the vicinity thereof. And in every instance, every instance where this patent
`application, this published patent application, talks about fixing a membrane
`or fixing an enzyme on a sensing window, it always says, "and in the
`vicinity thereof," without exception.
`So the layers that Hagiwara are put onto his sensors always
`covered both the sensing region, the electrochemically active surface, and
`the dielectric around it. There is no exception to that. None.
`In fact, the Board noted in its institution decision that -- and I think
`this was at page 12 -- that Claim 7 of Hagiwara describes the enzyme layers.
`So that was the claim on the enzyme layers, it describes the enzyme layers as
`covering the electrode reaction surface and the insulation layer. So that was
`in -- that was in Claim 7. As this -- as the Board noted in the institution
`decision.
`JUDGE ROESEL: So why is Petitioner de-emphasizing path B
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`today?
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`MR. GRIFFITH: Well, I didn't intend to do that. I think that it's
`not -- I think you'd come to the same result either way, and I will get into --
`JUDGE ROESEL: Is there some weakness in path B?
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`MR. GRIFFITH: No, Your Honor, not at all. It's just that I think
`we reach the same result either way, and while I hadn't planned to talk about
`path B as much, I am going to get into path B, in view of Your Honor's
`comments, but we reach the exact same result, and there really is -- I mean,
`it's the combination of these two things that yields this result.
`If we could go to slide 16. So these are the two electrodes, 1A,
`1D, and as I said at the outset, if you simply take the membrane system of
`1D -- and by the way, these are the Patent Owner's reproductions of what 1A
`and 1D in Hagiwara show. So their expert showed these to give a better
`visual, if you will, of Hagiwara 1A and 1D, Figure 1A and 1D.
`1D is on the bottom, it has the green. If you were to take that
`membrane system and simply place it on top of the wire above it, which is
`1A, you would have -- you would have an indwelling sensor according to
`Claim 1. You would have an enzyme layer that goes over the dielectric, it
`goes over the sensing window, and it's an indwelling sensor, and the sensing
`window has nubs and it covers the nubs and it covers the cavity in between.
`JUDGE ROESEL: But Petitioner agrees that there are -- the prior
`art teaches various techniques for putting an enzyme layer over a side sensor
`window, correct?
`MR. GRIFFITH: Yes, I think that's correct. So you could
`drop -- you could drop membrane onto it, you could dip coat, that sort of
`thing.
`
`JUDGE ROESEL: And some of those ways you end up with the
`enzyme layer only over the cavity and not over the nubs.
`MR. GRIFFITH: Not in Hagiwara. In Hagiwara --
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`JUDGE ROESEL: Well, Hagiwara doesn't show how to do it,
`
`right?
`
`MR. GRIFFITH: Hagiwara -- well, so the membrane system is dip
`coated. Hagiwara doesn't explicitly say how the enzyme layer is applied, but
`in Hagiwara, he describes that the enzyme layer, just like the membrane
`system, covers the reaction surface, so that's the electrochemically active
`surface, and it extends across in the vicinity thereof, and that's the dielectric.
`JUDGE ROESEL: But just because you dip coat one layer, does
`that mean that all layers are dip coated? I don't understand that.
`MR. GRIFFITH: It would be -- it doesn't necessarily mean that the
`enzyme layer is dip coated in Hagiwara, but that would be logical. I don't
`know why -- you know, why would there be an aversion to dip coating the
`enzyme layer when you can dip coat the cellulose acetate and you can dip
`coat the plastic that goes on that that has the heparin in it. I mean, it would
`be logical, but it doesn't matter, the claim isn't limited to dip coating, Your
`Honor, and the point -- so you don't have to dip coat to be within the scope
`of this claim. So you just have to have an enzyme layer -- membrane system
`that has an enzyme in it that surrounds the reaction surface and the dielectric
`around it. And Hagiwara always has that.
`JUDGE ROESEL: Yeah. I see what you're saying, but I also am
`reading this a bit through the eyes of Wilson, the other reference that you
`brought up.
`MR. GRIFFITH: Right.
`JUDGE ROESEL: And Wilson talks about various ways, right, to
`put the enzyme onto the --
`MR. GRIFFITH: Sure.
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`JUDGE ROESEL: -- side sensor window, including several ways
`that the enzyme ends up in -- well all of the ways, actually, in Wilson, that
`the enzyme ends up only in the cavity. So that's why, you know, when you
`say, oh, it's clear from Hagiwara that you would put -- if you put the enzyme
`layer in Figure 1A, it would always end up over the nubs. I think that's a
`point that doesn't -- hasn't been made very clearly.
`MR. GRIFFITH: Well, what I'm saying is that Hagiwara says,
`don't just put it on the reaction surface, add it in the vicinity thereof, and
`then you see that illustrated. We're not just working from illustrations, Your
`Honor, Hagiwara explicitly says put it on the reaction surface and in the
`vicinity thereof.
`JUDGE TORNQUIST: Do they give a reason for the vicinity
`thereof in Hagiwara?
`MR. GRIFFITH: There is not an explicit reason given, Your
`Honor, but the experts, our expert has testified to the -- you know, the ease
`of dip coating, and so -- and that you would want -- you want to have a
`complete coverage of the reaction surface. And so you don't want -- you
`know, if you stop short of the vicinity of -- or around the dielectric -- I'm
`sorry, around the reaction surface, then you would run the risk of not having
`the whole reaction surface covered with enzyme, and you want to have the
`reaction surface covered with enzyme.
`JUDGE TORNQUIST: No, I understand what the -- the diagrams
`show it extending well over the insulating layer, but would it necessarily go
`all the way over the nub to surround it?
`MR. GRIFFITH: Yes, Your Honor.
`JUDGE TORNQUIST: Okay.
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`MR. GRIFFITH: That's what he's saying, is that you put that
`sensing -- or I'm sorry, you put the membrane system or you put the enzyme
`layer on the reaction surface and in the vicinity thereof. And I believe that
`the desire for that is so that you don't leave some of the reaction surface
`uncovered. But he's explicit as to that -- his instructions that that's what one
`does.
`
`So the -- and I mean, that's -- and we have that, again, up here on
`page 2 of the patent -- of Hagiwara, lines 36 to 38. It describes that the
`enzyme covers the electrode reaction surface and the insulating outer
`surface. "And the insulating outer surface." And the Board pointed this out
`in its institution decision.
`JUDGE ROESEL: Okay, but stepping back from that, why would
`a person of ordinary skill in the art use the side sensor window with a sensor
`that has enzyme? In other words, a glucose sensor or a lactate sensor or
`something that has to have enzyme in order to work?
`MR. GRIFFITH: Well, or hydrogen or oxygen. But for any of
`these, you --
`JUDGE ROESEL: Those two don't need enzyme, right?
`MR. GRIFFITH: They don't need enzyme, but they have a
`membrane system there. And so by using a side-facing window, Dr. Vachon
`testified that you have a reduced risk of damage to the membrane system,
`and certainly the enzyme layer on the end surface of the sensor.
`So -- and when these go in, they go through -- you know, they go
`through an artery or a blood vessel, and then -- and so he testified that you
`can have damage to the membrane system, including the enzyme, at the end
`surface. The side surface is a little less risk of damage. Now, their expert
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`disagreed and said, no, you don't have to worry about that. And he
`said -- Dr. Smith said that, you know, you put this in with a catheter. You
`put this in with a catheter, so you don't have to worry about that.
`Well, actually, the patented sensor goes in with a catheter, too, but
`it's subcutaneous, but, you know, you use catheters for insertion.
`JUDGE TORNQUIST: But they had a different reason for the side
`sensor with the nubs than you're talking about here with Hagiwara.
`MR. GRIFFITH: That's true, Your Honor, but Wilson has -- I
`mean Hagiwara has a very clear teaching to cover the insulation, not just the
`reaction surface, and that's whether it's side-facing or end surface. Your
`Honor was asking why take that end surface sensor and use it in a
`side-facing direction, as, you know, a well-known alternative, right? So
`these -- the alternative of having -- of placing the sensing window, the '574
`patent does not purport to be the invention of a side-facing sensor window.
`That was well known. That was in Wilson. That was old stuff.
`So it's a known alternative, and our expert believes that one of the
`advantages of that is that you have a reduced risk of damage. And their
`expert said, you know, a side-facing sensor, that might run up against the
`blood vessel wall, and so you get reduced functionality, because you would
`have some of that side surface against the wall, but you would have -- you
`know, the other surface would not be -- opposite -- would not be against it,
`but, you know, you would have reduced functionality.
`But part of the damage that you could have with an end-facing
`sensor is if it goes into the wall or is pushing against the wall, you're not
`going to have any functionality with that end-facing surface. It doesn't
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`have -- it doesn't have like a side-facing surface, the other side, that at least
`would be sensing the analyte in question when it's within the blood vessel.
`So, look, both alternatives were offered up by Hagiwara, and both
`are well-known alternatives.
`JUDGE ROESEL: So let's say we're persuaded that these side
`sensor window and end-facing sensor window are known alternatives, right?
`MR. GRIFFITH: Yes.
`JUDGE ROESEL: Is that enough under the case law for a
`motivation to combine?
`MR. GRIFFITH: Umm --
`JUDGE ROESEL: And can you give me a case cite?
`MR. GRIFFITH: KSR would be my cite, Your Honor, but let me
`
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