Trials@uspto.gov Paper 26
`571-272-7822 Entered: June 17, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PHARMATECH SOLUTIONS, INC.,
`Petitioner,
`
`v.
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`LIFESCAN SCOTLAND LTD.,
`Patent Owner.
`____________
`
`Case IPR2013-00247
`Patent 7,250,105
`____________
`
`Held: May 14, 2014
`____________
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`
`
`
`
`Before: SALLY C. MEDLEY, SCOTT KAMHOLZ, and SHERIDAN
`SNEDDEN, Administrative Patent Judges.
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`
`
`APPEARANCES:
`ON BEHALF OF THE PETITIONER:
`
`
`A. JUSTIN POPLIN, ESQ.
`
`
`Lathrop & Gage LLP
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`
`10851 Mastin Boulevard
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`Building 82, Suite 1000
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`Overland Park, Kansas 66210-1669
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`
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`571-272-7822 Entered: June 17, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PHARMATECH SOLUTIONS, INC.,
`Petitioner,
`
`v.
`
`LIFESCAN SCOTLAND LTD.,
`Patent Owner.
`____________
`
`Case IPR2013-00247
`Patent 7,250,105
`____________
`
`Held: May 14, 2014
`____________
`
`
`
`
`
`Before: SALLY C. MEDLEY, SCOTT KAMHOLZ, and SHERIDAN
`SNEDDEN, Administrative Patent Judges.
`
`
`
`APPEARANCES:
`ON BEHALF OF THE PETITIONER:
`
`
`A. JUSTIN POPLIN, ESQ.
`
`
`Lathrop & Gage LLP
`
`
`10851 Mastin Boulevard
`
`
`Building 82, Suite 1000
`
`
`Overland Park, Kansas 66210-1669
`
`
`
`
`
`Case No. IPR2013-00247
`Patent No.7,250,105
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`
`
`ON BEHALF OF PATENT OWNER:
`
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`DIANNE ELDERKIN, ESQ.
`
`
`STEVEN D. MASLOWSKI, ESQ.
`
`
`Akin Gump Strauss Hauer & Feld LLP
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`
`Two Commerce Square
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`
`2001 Market Street, Suite 4100
`
`
`Philadelphia, Pennsylvania 19103-7013
`
`
`
`The above-entitled matter came on for hearing on Wednesday,
`May 14, 2014, commencing at 10:00 a.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 MEDLEY: Good morning. Please be seated.
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`Good morning, this is the hearing for IPR2013-00247 between
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`Petitioner Pharmatech Solutions and Patent Owner LifeScan Scotland.
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`Before we begin, we would like the parties to please introduce
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`themselves, beginning with Petitioner.
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`MR. POPLIN: Justin Poplin of Lathrop & Gage,
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`Petitioner, Judge.
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`JUDGE MEDLEY: Thank you. And for Patent Owner?
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`MS. ELDERKIN: Good morning, Diane Elderkin from
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`Akin Gump for LifeScan, and with me I have my partner Steve
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`Maslowski.
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`JUDGE: Thank you. As you know from the order we
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`sent out, each party will have 30 minutes of total time to present their
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`arguments. Petitioner, you will begin with the presentation of your
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`case with regard to the challenged claims on which base the Board
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`instituted the trial and thereafter the Patent Owner, you will respond to
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`Petitioner's presentation, and then, Petitioner, you may reserve
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`rebuttal time to respond to the Patent Owner's presentation.
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`So, Petitioner, you may begin, counsel, and would you
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`like to reserve rebuttal time?
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`MR. POPLIN: Yes, Judge, I would. I would like to
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`shoot for 15 minutes, please.
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`JUDGE MEDLEY: Fifteen minutes, okay, great. You
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`may begin.
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`MR. POPLIN: Would you like copies of the
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`presentation?
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`JUDGE MEDLEY: Yes, you may approach the Bench.
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`Before you get started, just a reminder to refer to the slide that you're
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`discussing so that it will be clear for the record.
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`MR. POPLIN: Yes, Judge.
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`JUDGE MEDLEY: Thank you.
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`MR. POPLIN: May I begin?
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`JUDGE MEDLEY: Yes, please.
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`MR. POPLIN: In this case, we have three claims, and we
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`have two grounds of rejections. The first ground is that Claims 1
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`through 3 are obvious in view of Nankai and Schulman, and the
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`second ground is that Claims 1 through 3 are obvious in view of
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`Winarta and Schulman. Dependent Claims 2 and 3 have not been
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`argued as patentable separately, so if Claim 1 falls, they all fall.
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`Here's Claim 1. It can be broken into two parts. The first
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`part being the structure of the test strip, and then the second part being
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`what is done with the test strip. So, they're providing a measuring
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`device, all those limitations are really the test strip limitations, and
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`everything else is what you do with it.
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`JUDGE KAMHOLZ: Mr. Poplin, do you contest any of
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`the claim constructions that were set out in our decision to institute?
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`MR. POPLIN: No, Judge, I believe those claim
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`constructions were all appropriate.
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`Starting with the test strip, LifeScan repeatedly tried and
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`failed to patent the test strip alone. They tried to patent the test strip
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`in the parent application, they tried to patent the test strip in the '105 --
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`in what became the '105 patent, and they also tried to patent the test
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`strip in a continuation application that became abandoned. Each time
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`they failed. There is not a patent on the electrical components of the
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`test strip owned by LifeScan without the method steps.
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`Not only has the patent office said that the strips are not
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`patentable, however, the Federal Circuit also in the context of an
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`exhaustion analysis said that the strips are not inventive. The issue
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`decided by the Federal Circuit was whether the transfer of the meter
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`alone, without the strips, exhausted the patent rights. LifeScan argued
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`to both the District Court and the Federal Circuit that exhaustion does
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`not apply to transfers of something alone, because the meters do not
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`embody the central features of the '105 patent.
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`So, here, the focus at District Court and in the Federal
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`Circuit, since the exhaustion focus was on the meter, the issue was
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`whether or not the strip was inventive, or not inventive. The Federal
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`Circuit found that exhaustion does apply. Excuse me, I'm on slide 6,
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`Judge.
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`The Federal Circuit found that exhaustion does apply,
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`rejecting their argument that the strips were the inventive features. In
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`doing so, the Federal Circuit noted that a biosensor with multiple
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`electrodes was not in the art. Strips with two working electrodes were
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`disclosed in the art, and that LifeScan repeatedly tried and failed to
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`patent the strip alone.
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`According to the Federal Circuit, and I quote, "Having
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`accepted the rejection of its claims drawn to the strips themselves, by
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`abandoning those claims in both its original and continuation
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`applications, LifeScan cannot now argue that the strips themselves
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`were the invention."
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`So, the Federal Circuit necessarily found that the test
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`strip elements were in the prior art when it decided that exhaustion
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`applied. The Federal Circuit admittedly did not reach the validity
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`issue that's in front of you today. It didn't need to. And that has no
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`effect at all on my collateral estoppel argument. I'm arguing collateral
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`estoppel, or issued conclusion. I am not arguing res judicata or claim
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`preclusion.
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`If it were the exact same claim, the invalidity claim, then
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`res judicata would apply, and that's not what we have here. We have
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`the same issue, and the issue is whether the test strips were inventive,
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`and the decision on that issue should carry over through issue
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`preclusion, or collateral estoppel.
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`JUDGE KAMHOLZ: I'm sorry, are you saying we are
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`bound to hold these claims unpatentable?
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`MR. POPLIN: You are bound to find -- I believe, Judge,
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`that through collateral estoppel, you cannot find that the test strips are
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`inventive. That issue was decided by the Federal Circuit in the
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`exhaustion context and that issue is necessarily decided by the Federal
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`Circuit. So, through collateral estoppel, we cannot come to a different
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`conclusion and we really shouldn't even be looking at the issue today.
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`Again, this is collateral estoppel and not res judicata,
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`which would be claim preclusion, that the exact same overall claim
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`invalidity was decided.
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`If we do, however, look past collateral estoppel, and look
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`to the structure of the test strip, we can look first to Nankai. Figure 12
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`from Nankai is shown on the slides, and this is slide 8, and in this
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`slide, figure, or elements 42 and 43 are the working sensors, element 5
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`will be the reference. When this is assembled, blood is inserted
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`through opening 10, it flows down the track, and then down through
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`slots 8.
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`The Patent Owner to date has made three claims, or three
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`arguments against Nankai, and we'll go through each in detail. The
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`first is whether or not the second working sensor part is downstream
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`from the first. As this hearing started today, there has already been a
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`claim construction on downstream, and it's been construed to mean
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`"further along a stream from its source." And Petitioner believes that
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`that construction is completely appropriate, and proper. And, if you
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`look at working sensor 42, it's further downstream. You have to go
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`down the horizontal stream before it branches off into what's on the
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`figure, which would go down -- down the channel 8. So, it's further
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`downstream than working sensor 43.
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`The second issue is whether the reference sensor part is
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`upstream from the working sensor parts. Petitioner acknowledges that
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`there's no explicit figure in Nankai that shows that. But that's okay.
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`According to Nankai, and I quote again, "The space of the shape is not
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`limited to those shown in the figures, likewise the shape or
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`arrangement of the electrode systems." Nankai tells us that the
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`sensors can be placed in different -- in different arrangements.
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`JUDGE KAMHOLZ: Isn't that with reference to the
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`working sensors?
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`MR. POPLIN: It is, Judge, but when you move the
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`working sensors, that's going to be relative to everything else, and that
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`would include being relative to the reference sensor.
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`JUDGE KAMHOLZ: But the disclosure in the '105
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`patent that you're relying on for that position, is at column 3, lines 36
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`through 58.
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`MR. POPLIN: That's actually in the Nankai patent,
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`Judge. I just quoted the Nankai disclosure, which is the second on the
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`JUDGE KAMHOLZ: Yes, I understand, but your
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`'105 patent that there is no criticality in the arrangement of the
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`MR. POPLIN: They go together, Judge. And that's
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`correct, the '105 also discloses that it's not critical, the arrangement,
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`but Nankai tells us that you can rearrange, also. So, not only does the
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`'105 patent tell us that you can rearrange, but Nankai tells us that we
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`can rearrange.
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`JUDGE KAMHOLZ: Where does the '105 patent
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`suggest that you could move the reference sensor relative to the
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`working sensors?
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`MR. POPLIN: If you're going to be moving the working
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`sensor, Judge, then that's necessarily relative to the reference sensor.
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`JUDGE KAMHOLZ: No, I'm sorry, where does the '105
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`patent suggest that it is possible to put the reference sensor upstream?
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`MR. POPLIN: In the '105 patent, Judge, the reference
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`sensor is claimed as being upstream.
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`JUDGE KAMHOLZ: The reference sensor is -- I'm
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`sorry, the reference sensor is claimed as being upstream. Where does
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`it suggest that the arrangement could be reversed?
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`MR. POPLIN: By indicating that the sensor parts may be
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`arranged as convenient within the device --
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`JUDGE KAMHOLZ: That's the working sensors.
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`MR. POPLIN: Yes, Judge, but it's also --
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`JUDGE KAMHOLZ: That disclosure doesn't address the
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`reference sensor.
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`MR. POPLIN: Judge, they're all within the device,
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`respectively. So, by rearranging them within the device, they are
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`necessarily being rearranged relative to the reference sensor.
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`JUDGE KAMHOLZ: Not necessarily. Not necessarily.
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`MR. POPLIN: Any time one would be moved and the
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`other would stay put, it would have to be moved relative to the other.
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`Now, the '105 patent does not specifically say, or at least I do not
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`believe that it says that the reference should be downstream, but it
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`tells us that the working sensors can be rearranged as convenient,
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`within the entire device, which would also include the reference.
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`JUDGE KAMHOLZ: Column 3, line 56 through 58, I
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`quote, "It is also preferred that both working sensor parts are
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`downstream of the reference sensor part." Maybe I misunderstand
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`your argument, but I understood at least in part it's based on the
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`assertion of the '105 patent that there's no criticality in the
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`arrangement of the sensors. This is argument, in fact, that Nankai
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`suggests the rearrangement.
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`MR. POPLIN: It is actually both, Judge. I believe that
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`based on Nankai that it tells us that you can rearrange these parts.
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`Now, that's a buttress by the '105, which says it's preferred, but it
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`doesn't say it's necessary, or it's required, or it must be upstream.
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`JUDGE KAMHOLZ: But what about the -- what about
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`LifeScan's arguments that there are advantages to that position?
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`MR. POPLIN: Those advantages, Judge, only come into
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`play if timing were an issue, which it's not. There are no time
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`limitations in the claims. It doesn't say you have to take a
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`measurement immediately upon the blood being applied to the strip,
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`or it must be done within two seconds. Those advantages are only
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`time sensitive. If you provide time for that blood to flow, there's no --
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`there's no advantage anymore. And those are not claimed properties.
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`We further have an expert declaration in the record that
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`indicates that the repositions was obvious to try. So, in addition to,
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`again, both Nankai and the '105 patent indicating that these parts can
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`be rearranged, we have an expert declaration in the record indicating
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`the same. And that it would be arduous to do so.
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`JUDGE KAMHOLZ: I'm sorry, that's paragraph 25?
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`MR. POPLIN: Yes, Judge.
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`JUDGE KAMHOLZ: Of the Wang declaration?
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`MR. POPLIN: Of the Wang declaration, Exhibit 1024,
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`page 9 at paragraph 25.
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`The third argument that's been made by Patent Owner is
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`in regard to flow being substantially unidirectionally across the
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`reference and the working sensor parts. Here flow is unidirectional.
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`When it comes in, before it goes across the working sensor parts, it's
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`all going in one direction. In this slide, it's going from top to bottom.
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`There's no requirement in the claims that it has to be a single path, as
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`Patent Owner has argued. That's not in the claims.
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`This flow doesn't go back up the channels, it doesn't
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`zig-zag through the channels, it flows in one direction. It flows from
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`the top down past the working sensors and the reference sensor.
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`Those are the test strip limitations with Nankai.
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`Now we start on the steps that indicate what's done with
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`the test strip. The first two applying the liquid and measuring current
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`at each of the parts has not been disputed. Nankai clearly shows
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`those. The final two steps, the comparison and the error indication
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`steps are both met based on a combination with Schulman.
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`The '105 patent requires comparing the electric current
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`from each of the working sensor parts to establish a difference
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`parameter, and requires giving an indication of an error if the
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`difference parameter is greater than a predetermined threshold. That
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`comes right out of the Schulman disclosure. And, in fact, part of
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`Schulman is reproduced on slide 13. It says, "In accordance with one
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`aspect of the invention, a plurality of glucose or other sensors, e.g. at
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`least two sensors, are inserted into a vein or other appropriate location
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`of the patient, and are coupled to the monitor with a concentration
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`measurement being provided by each sensor. A prescribed degree of
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`correlation must exist between the readings from each sensor in order
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`to validate the correctness of the concentration measurement that is
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`made. If the prescribed degree of correlation does not exist, then the
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`monitor automatically indicates that a recalibration and/or new
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`sensors is required."
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`That's exactly the steps that are claimed in the '105
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`patent. It's also claimed in Claim 15 of Schulman.
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`To sum up Petitioner's position regarding the comparison
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`and error indication steps, the steps are measuring electric currents,
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`comparing them and getting an indication of error if they differ by a
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`given amount are not something that was new or innovative at the
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`time of the invention of the '105 patent. Systems that use redundancy
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`as a reliability check have existed for a long time.
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`The process of measuring and comparing signals and
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`giving an indication of error was widely known and not inventive as
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`of the time of the '105 patent. If the Patent Owner disagrees with that
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`summary, it should specifically say so today.
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`So, in ground one, there's nothing new about the strip, or
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`the test or the steps performed by the meter, and use of the two in
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`Claim 1 is not patentable. The combination was the use of a known
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`technique of Schulman, to improve the Nankai device in the same
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`way, with predictable results.
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`Turning quickly now to the second ground of rejection
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`based on Winarta, the Schulman -- the use of Schulman is the same.
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`So, we're just looking at a different test strip configuration. The same
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`configuration, but a different prior art reference to meet the test strip
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`claim limitations. In Winarta, what we have is we have a reference
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`sensor that's upstream of two working sensors W and WO. Blood is
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`Patent No.7,250,105
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`inserted at the tip, and flows downstream. So, from the top of the
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`page to the bottom, in slide 14.
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`The only real argument that Patent Owner has made here
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`is based on the second working sensor part. The claim requires the
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`quantity of charge carriers generated by the second working sensor
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`part to be substantially identical to those generated by the first.
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`Winarta's first and second working sensor parts are constructed in the
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`same way, they include the exact same reagent, and they're arguably
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`the same size.
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`Even if they're not the same size, however, one of
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`ordinary skill in the art, when combining Winarta with Schulman,
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`would make them the same size. Why? Because Schulman tells us to
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`take multiple samples to compare them, and to give an error indication
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`if it's over a difference threshold. If these results are too different,
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`they output an error. So, one of skill in the art would make these the
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`same size, based on the Schulman reference.
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`As with the first ground of rejection, there's nothing new
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`with the strip. There's nothing new about the steps being done with
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`the strip. And the combination is not patentable. Again, we're using
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`the Schulman teachings to improve a prior art strip, Winarta, in the
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`exact same way as Schulman teaches. And we're obtaining
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`predictable results.
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`With that, Judges, unless there are any other questions, I
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`would reserve the remainder of my time.
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`JUDGE MEDLEY: Okay, thank you, you have about ten
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`minutes remaining.
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`MR. POPLIN: Thank you.
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`MS. ELDERKIN: If we may approach with copies of
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`our slides?
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`JUDGE MEDLEY: Yes, thank you.
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`MS. ELDERKIN: Good morning. The '105 patent at
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`issue here is a commercially valuable patent, it was allowed by the
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`Patent Office after consideration of two of the three references that are
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`now before the Board, Schulman and Nankai, and it addresses a
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`problem with disposable test strips and the accuracy of those test
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`strips due to manufacturing defects or insufficient blood sample.
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`Now, in this proceeding, Petitioner has the burden,
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`Petitioner has the burden of proving by a preponderance of the
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`evidence that Claims 1 to 3 are not patentable and should not have
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`been issued. Petitioner's case is built upon conclusory expert
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`statements and attorney argument, and their argument suggests that
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`every element of the claims is found in the combination of references,
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`and that those skilled in art at the time, looking at the disposable test
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`strips inventions, would have been motivated to combine those
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`references.
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`I'm going to, in my time today, I'm going to go through
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`three main points why Petitioner has not met their burden. First, that
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`all of the elements in the claim are not found in either the combination
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`of references, and second, that somebody skilled in the art would not
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`Patent No.7,250,105
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`have been motivated to look to Schulman, which relates to a
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`fundamentally different technology, for addressing the problems with
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`disposable test strips. And third, that there is also objective evidence
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`of nonobviousness here in terms of copying.
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`Finally, I will address briefly the collateral estoppel
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`argument that Petitioner has made. I won't spend a lot of time on this
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`because I think counsel already covered this, that this lengthy patent
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`claim, Claim 1, is has elements that we've sort of broken down into
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`test strip elements and method strip measurements, but here on slide
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`2, we've highlighted the portions of the test strip elements that really
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`are key for the arguments that we're making today.
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`First, that there have to be first and second working
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`sensor parts, and the sensor parts are electrodes. Sensor part and
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`electrode are used interchangeably for this purpose. And it's
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`important to note that the sensor part is required by the claims to
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`generate charge carriers, in other words electrons, current, in
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`proportion to the concentration of the substance being measured, i.e.
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`the glucose in the blood sample. So, first and second electrodes that
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`make measurements of the sample.
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`And then a reference sensor that is upstream from both of
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`those electrodes. Those are the key test strip elements that we're
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`talking about.
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`Then in slide 3 are the applying, measuring, comparing,
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`giving an indication steps. These are the steps for which they rely on
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`the Schulman reference, or disclosure.
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`Case No. IPR2013-00247
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`JUDGE KAMHOLZ: Do you contest any of the claim
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`constructions made in the decision to institute?
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`MS. ELDERKIN: We did, Your Honor, we proposed
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`different constructions, both for downstream or upstream, and I
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`apologize, I forget which term it was, and also for unidirectional;
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`however, for the purpose of the evidence that we've put in, for the
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`purpose of the argument today, we are applying the Board's
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`construction. Even under the Board's construction, we believe that the
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`Petitioner has not met their burden of proving that these claims are not
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`patentable.
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`JUDGE KAMHOLZ: You proposed other constructions
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`in the preliminary response?
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`MS. ELDERKIN: Correct.
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`JUDGE KAMHOLZ: Have you maintained those in the
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`Patent Owner response?
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`MS. ELDERKIN: We did not say anything in the Patent
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`Owner response about those constructions.
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`JUDGE KAMHOLZ: So, are you in agreement with the
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`Board's construction?
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`MS. ELDERKIN: We did not dispute them in our Patent
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`Owner's response.
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`On slide 4, again, it just breaks down that the Winarta
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`and the Nankai references are the references on which Petitioner relies
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`for the test strip elements, Schulman for the measuring, comparing,
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`error detection steps.
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`So, let me talk about reason number one why Pharmatech
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`has or Petitioner has not met its burden, and that has to do with the
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`fact that the combination of references simply do not disclose all of
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`the claimed elements. And let me focus first on the Nankai plus
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`Schulman combination, or specifically Nankai. Nankai, as you heard
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`earlier, discloses a biosensor for measuring blood glucose, it does
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`have first and second electrodes and a reference electrode, and the
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`measurements in Nankai from the two electrodes are averaged with
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`one another, so they are not addressing the same issue as the '105
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`patent. And that is why Petitioner relies on a different reference for
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`the measuring, comparing, error indication.
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`But the key for the purpose of our argument today, the
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`key element that is not disclosed by Nankai is the fact that the
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`reference sensor part must be upstream from the first and second
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`working sensor parts. There is no dispute about that. Dr. Wang,
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`Petitioner's declarant, says as much, he agrees, there's no disclosure of
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`this in Nankai.
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`But Pharmatech in their argument, Petitioner brushes this
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`off. They say, well, there's no criticality in arranging the electrodes as
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`is required by the '105 patent claims. Nothing critical about placing
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`the reference electrode upstream of the working electrodes.
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`But that's not the case. The only evidence on this is the
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`evidence submitted by Patent Owner in the declaration of Dr. Smith,
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`Exhibit 2008, where he explains that there is criticality in arranging
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`the reference -- the reference electrode upstream. And this is in
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`Patent No.7,250,105
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`paragraph 43 of his declaration. And he explains that since the
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`reference electrode in Nankai is placed downstream of the working
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`electrodes, that that could cause a problem for accuracy, because if
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`insufficient blood is supplied, and not enough blood gets to that
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`downstream reference electrode to completely cover it, that electrode
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`then is completely -- not completely covered, and would not serve its
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`purpose of acting as a reference electrode. It could cause a higher
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`than normal current density to flow from the covered part of the
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`reference electrode and that would alter the ability of the reference
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`electrode to provide a staple potential against which the working
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`electrodes could be established. And this could potentially cause
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`inaccuracies.
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`So, this is the testimony of Dr. Smith, Petitioner has no
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`answer to this testimony. They did not dispose Dr. Smith, they did
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`not challenge this testimony, they did not present any expert
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`testimony of their own on this point. This testimony is on the record,
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`it's unrebutted.
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`JUDGE KAMHOLZ: The testimony certainly identifies
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`advantages to positioning the reference electrode upstream.
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`criticality?
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`MS. ELDERKIN: Yes.
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`JUDGE KAMHOLZ: But how does this establish
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`MS. ELDERKIN: It establishes criticality because if the
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`reference electrode is downstream, you would have accuracy
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`problems, and the whole point of the '105 patented invention is to
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`Case No. IPR2013-00247
`Patent No.7,250,105
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`improve the accuracy of test strips. Now, their concern was with
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`incomplete sample, a problem with these -- I don't want to interrupt
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`you, Judge.
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`JUDGE KAMHOLZ: But in the '105 patent, it's
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`discussed that there are risks, and there's always a certain chance that
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`the blood is not going to cover everything it needs to cover evenly.
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`There's always a risk of that. The '105 patent says, column 3, line 50
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`to 51, "If the above-mentioned small risk is deemed anticipatable,
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`then arrangement in accordance with the invention allows a much
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`greater flexibility in the placement of the sensor parts."
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`MS. ELDERKIN: Well, as Your Honor asked earlier, I
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`think you asked counsel whether there was any disclosure in the '105
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`patent about placing the reference sensor anywhere other than
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`upstream, and I would answer that question by saying, no, there is no
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`disclosure of anything other than placing it upstream. And the whole
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`focus of the '105 patent is to minimize the risk attendant to having
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`insufficient sample applied to one of these test strips.
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`If you've ever had a family member or friend who has to
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`deal with these test strips, you know the difficulty of getting a blood
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`sample and pricking your finger or your arm to get a sufficient blood
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`sample. So, that's always a concern of these test strip manufacturers
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`that insufficient sample will be applied, and as a result of that, the
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`patient will get an inaccurate result. And that was a focus of this
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`patent.
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`Case No. IPR2013-00247
`Patent No.7,250,105
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`One of the reasons for putting the reference sensor
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`upstream was to make sure that at least there would be sufficient
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`blood to cover that reference sensor. So that you would always have a
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`good reference potential -- a good potential established between the
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`reference electrode and the working electrodes, so that a measurement
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`could be made -- a realistic measurement could be made of the
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`working electrodes, and then those measurements could be compared,
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`because by the time you get to that last downstream working
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`electrode, there might not be enough blood, and so the readings of the
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`two electrodes might be different enough that the meter would say,
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`hold off, you've got an error here, we've got to do this test again.
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`Did that answer your question, Judge?
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`JUDGE KAMHOLZ: The patent, the '105 patent, as I
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`quoted before, describes positioning the working sensors downstream
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`of the reference sensor as a preference, not as a necessity.
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`MS. ELDERKIN: It does use -- you're right, Your
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`Honor, it does say it is preferred, but there is no disclosure anywhere
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`else of it being upstream. There is that language it is also preferred,
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`but that is the only disclosure, there's no disclosure, there's no
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`drawing, there's no figure, there's no claim, anything to the reference
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`electrode being other than upstream of the working sensors, and that is
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`clearly what is claimed here.
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`JUDGE KAMHOLZ: Doesn't disclosing one
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`embodiment as a preference imply pretty strongly that the opposite
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`embodiment is at least envisioned?
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`Case No. IPR2013-00247
`Patent No.7,250,105
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`MS. ELDERKIN: It -- it might have been envisioned,
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`Your Honor, but it certainly wasn't preferred, and it wasn't --
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`JUDGE KAMHOLZ: Well, I mean, as a person of
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`ordinary skill in the art reading this patent, reading that sentence.
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`MS. ELDERKIN: Well, to the extent that that might be
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`the case that's rebutted by the expert -- the testimony that we have of
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`the only person skilled in the art
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