throbber
Paper 11
`Entered: August 15, 2013
`
`Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`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
`_______________
`
`Before SALLY C. MEDLEY, SCOTT R. BOALICK, and SCOTT E. KAMHOLZ,
`Administrative Patent Judges.
`
`
`
`KAMHOLZ, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
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`Case IPR2013-00247
`Patent 7,250,105
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`I.
`
`INTRODUCTION
`
`A. Background
`
`Pharmatech Solutions, Inc. (“Pharmatech”) filed a petition (Paper 1, “Pet.”)
`requesting an inter partes review of claims 1-3 (the “challenged claims”) of
`U.S. Patent 7,250,105 (Ex. 1001, “the  ’105 patent”). Patent Owner LifeScan
`Scotland Ltd. (“LifeScan”) filed a preliminary response (Paper 10,
`“Prelim. Resp.”). The standard for instituting an inter partes review is set forth in
`35 U.S.C. § 314(a), which provides as follows:
`THRESHOLD.—The Director may not authorize an inter
`partes review to be instituted unless the Director
`determines that the information presented in the petition
`filed under section 311 and any response filed under
`section 313 shows that there is a reasonable likelihood
`that the petitioner would prevail with respect to at least 1
`of the claims challenged in the petition.
`
`Upon consideration of the petition and patent owner preliminary response,
`we conclude that Pharmatech has established a reasonable likelihood that it would
`prevail with respect to claims 1-3 of the ’105 patent. Accordingly, we grant the
`petition and institute an inter partes review of claims 1-3 of the ’105 patent.
`
`B. Related Proceedings
`
`Pharmatech indicates that the ’105 patent is involved in a civil action
`captioned LifeScan, Inc. v. Shasta Techs., LLC, No. 5:11-CV-04494-EJD
`(N.D.Cal). Pet. 2. Pharmatech is a co-defendant in that action. Id. LifeScan
`indicates that a preliminary injunction, issued in that action, has been stayed
`pending Pharmatech’s appeal to the U.S. Court of Appeals for the Federal Circuit,
`where the case is now under consideration. Prelim. Resp. 10-11.
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`Patent 77,250,105
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`C. The ’1055 Patent
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`C T
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` s
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`The ’105 paatent relatees to monittoring the llevel of a ssubstance iin a liquid,
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`particullarly the levvel of gluccose in bloood. Ex. 10002, 1:7-100. A glucoose assay is
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`
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`performmed by inseerting a test strip intoo a meter annd then appplying a drrop of bloood to
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`
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`the test strip. Id. 55:14-25. TThe test str
`ip is made
`
`
`
` from layeers of varioous materiaals,
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`
`
`built upp on a plasttic base andd capped wwith a coveer. Id. 4:355-5:14. Figgure 2 is
`
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`
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`reproduuced beloww:
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`
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`s arbon ink isattern of cawhich a past strip, in wr of the tesFigure 22 illustrates one layer
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` Id. 4:23-224. The caarbon ink fforms threee
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`screen-pprinted ontto the test sstrip base.
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`tracks 44, 6 (not labbeled), andd 8 (not labbeled), alonng the stripp, as well aas a
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`connectting bridgee 10. Id. 4::44-51. Eaach track hhas a conneecting termminal 4a, 6aa, 8a
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`at one eend of the sstrip and ann electrodee 4b, 6b, 8bb at the othher end. Idd. A layer
`of
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`glucosee oxidase (““GOx”) is printed onn the electroodes. Id. 44:65-66. VVarious othher
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`of
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`layers aare depositeed to definne the rest oof the struccture, suchh as the preecise sizes
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`the elecctrodes andd a flow patth for the bblood. Id.
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`4:54–5:144.
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`A user begins a glucose measurement by inserting the terminal end of the
`test strip into a meter device; the connecting bridge completes a circuit upon
`insertion to turn on the device. Id. 5:16-18. The device applies a voltage between
`the reference terminal 4a and terminal 6a, and also between the reference terminal
`4a and terminal 8a. Id. 5:19-22. A drop of blood is deposited at the distal end of
`the strip, and the blood is drawn over electrodes 4b, 6b, and 8b by capillary action.
`Id. 5:23-26. The blood thereby comes into contact with the GOx printed on the
`electrodes, and the GOx reacts with glucose in the blood to release electrons. The
`resulting electric currents through carbon tracks 4 and 6 are proportional to both
`the surface area of the electrode covered by GOx and the amount of glucose in the
`blood sample. Id. 1:27-38. Because the GOx surface area is known, the electric
`current is indicative directly of the amount of glucose in the blood. Id. The
`currents are measured by the meter device after a predetermined time. Id. 5:26-27.
`The current measurements are compared to one another, and if they differ by more
`than 10%, an error message is displayed so that the user will know to repeat the
`test. Id. 5:27-30. If they are within 10% of each other, the measured currents are
`summed and converted into a glucose level, which is then displayed. Id. 5:30-33.
`The challenged claims are reproduced below:
`1. A method of measuring the concentration of a
`substance in a sample liquid comprising the steps of:
`providing a measuring device said device comprising:
`a first working sensor part for generating charge
`carriers in proportion to the concentration of
`said substance in the sample liquid;
`a second working sensor part downstream from
`said
`first working sensor part also
`for
`generating charge carriers in proportion to the
`concentration of said substance in the sample
`liquid wherein said first and second working
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`sensor parts are arranged such that, in the
`absence of an error condition, the quantity of
`said charge carriers generated by said first
`working sensors part are substantially identical
`to the quantity of said charge carriers generated
`by said second working sensor part; and
`a reference sensor part upstream from said first and
`second working sensor parts which reference
`sensor part is a common reference for both the
`first and second working sensor parts, said
`reference sensor part and said first and second
`working sensor parts being arranged such that
`the sample
`liquid
`is constrained
`to flow
`substantially
`unidirectionally
`across
`said
`reference sensor part and said first and second
`working sensor parts; wherein said first and
`second working sensor parts and said reference
`sensor part are provided on a disposable test
`strip;
`applying the sample liquid to said measuring device;
`measuring an electric current at each working sensor
`part proportional to the concentration of said
`substance in the sample liquid;
`comparing the electric current from each of the
`working sensor parts to establish a difference
`parameter; and
`giving an indication of an error if said difference
`parameter
`is greater
`than a predetermined
`threshold.
`
`
`
`2. The method as claimed in claim 1 comprising
`measuring the current at each working sensor part after a
`predetermined time following application of the sample.
`
`
`3. The method as claimed in claim 1 wherein the
`substance to be measured is glucose, and each of the
`working sensor parts generates charge carriers
`in
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`proportion to the concentration of glucose in the sample
`liquid.
`
`D. Prior Art Relied Upon in the Petition
`
`Pharmatech relies upon the following references, as well as the declaration
`of Professor Joseph Wang, D.Sc. (Ex. 1024):
`
`Horii
`Ex. 1011
`Apr. 2, 1991
`US 5,004,998
`Ex. 1003
`Jun. 9, 1992
`US 5,120,420
`Nankai
`Sep. 30, 1997 Ex. 1006
`US 5,672,256
`Yee
`Aug. 11, 1998 Ex. 1007
`Schulman US 5,791,344
`Jan. 16, 2001
`Ex. 1004
`US 6,175,752
`Say
`Jul. 10, 2001
`Ex. 1005
`US 6,258,229
`Winarta
`Apr. 1, 2003
`Ex. 1010
`Stewart
`US 6,540,891
`Khazanie Statistics in a World of Applications 1997
`Ex. 1008
`Data and Error Analysis in the
`Lichten
`1996
`Ex. 1009
`Introductory Physics Laboratory
`
`
`
`
`E. The Asserted Grounds of Unpatentability
`
`Pharmatech asserts that the challenged claims are unpatentable based on the
`following grounds (Pet. 4-5):
`1. Claim 1 is unpatentable under 35 U.S.C. § 103(a) over Nankai and Say; or
`over Nankai, Say, and Winarta; or over Nankai, Say, and Yee; or over
`Nankai, Say, Winarta, and Yee;
`2. Claim 1 is unpatentable under 35 U.S.C. § 103(a) over Nankai and
`Schulman; or over Nankai, Schulman, and Winarta; or over Nankai,
`Schulman, and Yee; or over Nankai, Schulman, Winarta, and Yee;
`
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`3. Claim 1 is unpatentable under 35 U.S.C. § 103(a) over Nankai and
`Khazanie; or over Nankai, Khazanie, and Winarta; or over Nankai,
`Khazanie, and Yee; or over Nankai, Khazanie, Winarta, and Yee;
`4. Claim 1 is unpatentable under 35 U.S.C. § 103(a) over Nankai and
`Lichten; or over Nankai, Lichten, and Winarta; or over Nankai, Lichten,
`and Yee; or over Nankai, Lichten, Winarta, and Yee;
`5. Claim 1 is unpatentable under 35 U.S.C. § 103(a) over any of the
`combinations listed in 1–4 above, in further combination with Stewart;
`6. Claim 1 is unpatentable over any of the combinations listed in 1–4 above,
`in further combination with Horii;
`7. Claim 1 is unpatentable under 35 U.S.C. § 103(a) over Winarta and Say;
`8. Claim 1 is unpatentable under 35 U.S.C. § 103(a) over Winarta and Horii;
`9. Claim 1 is unpatentable under 35 U.S.C. § 103(a) over Winarta and
`Schulman;
`10. Claim 1 is unpatentable under 35 U.S.C. § 103(a) over Winarta, Yee, and
`Khazanie;
`11. Claim 1 is unpatentable under 35 U.S.C. § 103(a) over Winarta and
`Lichten;
`12. Claim 2 is unpatentable under 35 U.S.C. § 103(a) over any combination
`listed in 1-11 above; and
`13. Claim 3 is unpatentable under 35 U.S.C. § 103(a) over any combination
`listed in 1-11 above.
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`II. DISCUSSION
`
`A. Claim Construction
`
`In an inter partes review, claim terms in an unexpired patent are interpreted
`according to their broadest reasonable construction in light of the specification of
`the patent in which they appear. 37 C.F.R. § 42.100(b); Office Patent Trial
`Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012). Also, claim terms are
`given their ordinary and customary meaning as would be understood by one of
`ordinary skill in the art in the context of the entire disclosure. In re Translogic
`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definition for a
`claim term must be set forth in the specification with reasonable clarity,
`deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`1. “Proportion” and “proportional to”
`Pharmatech and LifeScan agree that the terms “proportion” and
`“proportional to” in the claims should be construed as “correlated to.” Pet. 5-6;
`Prelim. Resp. 11-14. Upon consideration of the record, the agreed-upon
`construction of the terms “proportion” and “proportional to” to mean “correlated
`to” is consistent with the plain and ordinary meaning in the context of the
`specification. We adopt the agreed upon construction.
`2. “Downstream”
`According to LifeScan, a first working sensor part is not “downstream” of a
`second working sensor part unless the first part is covered completely before the
`second part begins to be covered, thereby avoiding any possibility that insufficient
`sample is applied to cover both working sensor parts. Prelim. Resp. 17-18 (citing
`Ex. 1002, 3:43-50).
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`We do not agree. The cited passage of the ’105 patent describes certain
`properties and benefits that result from the particular downstream arrangement the
`patent discloses. The term “downstream” itself indicates that the position of one
`item is further along a stream from the source of the stream than is another item.
`Accordingly, for purposes of this decision, we construe “downstream” to mean
`“further along a stream from its source.”
`3. “Substantially unidirectionally”
`LifeScan contends that “substantially unidirectionally” in the context of the
`flow of a liquid means substantially unidirectionally along a single path, not along
`multiple, parallel paths. Prelim. Resp. 17-18 (citing Ex. 1002, 3:43-50).
`Again, we do not agree. Nothing in the passage LifeScan cites indicates that
`a unidirectional flow must be along a single path. Accordingly, for purposes of
`this decision, we construe “substantially unidirectionally” to mean “along, or
`nearly along, one direction.”
`
`B. Obviousness over Nankai and Schulman
`
`Pharmatech argues that claims 1-3 are unpatentable under 35 U.S.C. § 103(a)
`over Nankai in various combinations with other references. See section I.D, supra.
`Upon consideration of the parties’ arguments and evidence, we are persuaded that
`Pharmatech has demonstrated a reasonable likelihood that claims 1-3 are
`unpatentable as obvious over Nankai and Schulman. We deny as redundant all
`other challenges based on Nankai.
`1. Overview of Nankai
`Nankai describes disposable biosensors for measuring, e.g., glucose
`concentration in blood. Ex. 1003, 3:65-68. Figure 12 of Nankai is reproduced
`below:
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`d 1 on whichh is formed
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`FFigure 12 shhows a gluucose sensoor having bbase plate
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`lead 3 aand correspponding coounter electtrode 5, annd leads 21
`
`, 22, and 223, and
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`correspoonding meeasurementt electrodess 41, 42, annd 43. Id.
`pacer 7
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`8:5-10. S
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`the spacerr provides aa conduit ffor a
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`overliess the base pplate, and sspace 8 cutt out from
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`blood saample to fllow from inntroducingg port 10 too the meas
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`urement annd counterr
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`electroddes. Id. Abbstr., 8:15-18. Coverr 9 providees dischargge ports 11,, 12, and 1
`3,
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`throughh which air leaves spaace 8 as it iis displaceed by the fllowing blo
`od. The
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`
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`measureement elecctrodes are coated witth GOx. Idd. 5:1, 8:1
`ood
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`1-14. Duriing use, bl
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`enters thhrough thee introducinng port andd flows aloong the maain conduitt of space 88,
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`with portions of thhe sample entering suuccessive bbranches aalong the mmain conduuit.
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`Id. 8:255-27. A current meassurement iss made at eeach senso
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`r, and the mmeasuremeents
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`are averraged to give a final rresult. Id. 8:42-46.
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`2. Overview of Schulman
`Schulman describes an implantable sensor used to monitor blood glucose
`continuously by GOx-mediated current measurements. Ex. 1007, 3:17-28,
`4:20-30, 7:35-37. Two or more sensors may be used to confirm the correctness of
`the measurement. Id. 4:46-50. The readings from two sensors are compared, and
`if they are not within 10% of one another, the system requests sensor recalibration
`(id. 11:16-22, 20:50-54), and issues an error message advising the user to check the
`sensors. Id. 21:9-13.
`3. Analysis
`Pharmatech argues that Nankai discloses all limitations of claim 1 except (a)
`the position of the reference sensor part “upstream” of the first and second working
`sensor parts, (b) the step of comparing the electric current from each of the
`working sensor parts to establish a difference parameter; and (c) the step of giving
`an indication of an error if the difference parameter is greater than a predetermined
`threshold. Pet. 16-21.
`With regard to limitation (a), Pharmatech argues that while Nankai positions
`the reference sensor part (i.e., counter electrode 5) downstream of the working
`sensor parts 43, 42, a person of ordinary skill in the art would have known that
`there was a finite number of ways to arrange a reference sensor part in relation to a
`working sensor part and that repositioning the reference sensor part upstream from
`the working sensor parts, as opposed to downstream from the working sensor parts,
`would have been obvious to try. Id. at 16, 19 (citing Ex. 1024 (Wang Decl.) ¶ 25).
`Pharmatech also argues that there is no criticality in arranging the reference
`electrode upstream and points to disclosure in the ’105 patent indicating that the
`working sensors may be “arranged as convenient.” Id. (citing Ex. 1024 ¶ 25 and
`Ex. 1002, 3:36-58).
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`Pharmatech’s rationale that it would have been obvious to reposition the
`reference sensor part to be upstream of the working sensor parts is reasonable and
`supported by record evidence. LifeScan has not demonstrated otherwise.
`With regard to limitations (b) and (c), Pharmatech argues that Schulman
`discloses them and that modifying Nankai to include these steps would have been
`nothing more than the application of a known technique to improve a similar
`device with predictable results. Id. at 16-17, 21; Ex. 1024 ¶¶ 27-28.
`LifeScan argues that Schulman is concerned with “continuous
`measurement” of glucose, not periodic measurements made with disposable strips,
`and that Pharmatech has not explained why one of ordinary skill would have
`looked to such a reference when considering modifications to Nankai. Id. at 23-24,
`27-29. According to LifeScan, “continuous measurement” art, such as Schulman,
`is non-analogous to the single-use, disposable subject matter claimed in the ’105
`patent, because each faces problems the other does not. Prelim. Resp. 28; Ex. 2001
`¶¶ 116-117.1 LifeScan argues that the combination of Nankai and Schulman is
`based, therefore, on hindsight reasoning. Id. LifeScan also argues that Dr. Wang’s
`statements regarding obviousness of the combination are conclusory assertions that
`should be given no weight, while those of Dr. Meyerhoff are not conclusory and
`should be given weight. Prelim. Resp. 28-29.
`We are unpersuaded by LifeScan’s arguments. Dr. Wang’s opinion
`testimony is unnecessary to support Pharmatech’s argument that one of ordinary
`skill would have considered Schulman. Schulman, Nankai, and the ’105 patent
`
`1 Exhibit 2001 is a declaration by Dr. Mark E. Meyerhoff, a professor of chemistry
`at the University of Michigan. Ex. 2001 ¶ 1. It was submitted in evidence by
`LifeScan in the civil action identified in section I.B, supra.
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`each are concerned with measuring blood glucose, and each uses the same
`fundamental technique of measuring GOx-mediated electrical current. LifeScan’s
`arguments and expert testimony ignore this fundamental common theme among
`the ’105 patent and the cited art and instead place undue emphasis on differences
`between the “continuous” and “single-use” settings in which this common
`technology is used. Schulman’s descriptions of how to interpret current signals
`from its blood glucose sensors are relevant to other blood glucose sensor systems
`that generate like signals, regardless of the particular setting in which the sensors
`are used. Schulman is thus not non-analogous to the ’105 patent or to disposable
`single-use test strips more generally.
`Pharmatech relies on Schulman for disclosure of a particular way in which
`multiple measurements from a single blood sample are compared and used to alert
`the user to an unreliable test; that Schulman happens to disclose this method in the
`context of continuous monitoring by an implanted electrode instead of intermittent
`monitoring by a disposable electrode is of no moment.
`LifeScan argues further that Nankai’s second working sensor part is
`positioned parallel to the first working sensor part, not (d) downstream of the first
`working sensor part. Prelim. Resp. 17 (citing Ex. 2001 ¶¶ 72-74). LifeScan also
`argues that Nankai’s sensor parts are not (e) arranged such that the sample liquid is
`constrained to flow substantially unidirectionally across them. Id. at 17-18 (citing
`Ex. 2001 ¶ 74).
`LifeScan’s arguments concerning limitations (d) and (e) do not persuade us
`that Pharmatech’s reliance on Nankai is misplaced. As to limitation (d), sensor 42
`is “downstream” of sensor 43 in the sense that it is further along space 8 from
`introducing port 10 than is sensor 43. See section II.A.2, supra. The branch for
`sensor 42 takes off from the main conduit of space 8 at a point further along the
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`direction of flow than does the branch for sensor 43. We discern no limitation that
`excludes Nankai’s parallel branch structure from the scope of claim 1.
`As to limitation (e), LifeScan argues that the flow is not substantially
`unidirectional because it is divided into multiple, parallel flow paths with only one
`working sensor part per path. Prelim. Resp. 17-18 (citing Ex. 2001 ¶ 74). But
`claim 1 does not require that the sample liquid be constrained to flow substantially
`unidirectionally across all three sensor parts in a single path. See section II.A.3,
`supra. Within each branch, the sample liquid flows along, or nearly along, one
`direction over one working electrode and then over the common counter electrode.
`Id. Moreover, the direction of flow in each branch is the same: toward the front
`edge of the strip, as shown in Figure 12. Thus, the sample liquid flows
`substantially unidirectionally across each electrode.
`We agree as well with Pharmatech that Nankai discloses the limitations of
`claims 2 and 3, and that those claims would have been obvious over Nankai and
`Schulman for reasons similar to those given above. LifeScan’s arguments are
`directed to claim 1, and LifeScan does not address claims 2 and 3 with separate
`specific arguments. See, e.g., Prelim. Resp. 17-18.
`For these reasons, Pharmatech has demonstrated a reasonable likelihood of
`prevailing on the ground of unpatentability of claims 1-3 as obvious over Nankai
`and Schulman.
`
`C. Obviousness over Winarta
`
`Pharmatech argues that claims 1-3 are unpatentable under 35 U.S.C. § 103(a)
`over Winarta in various combinations with other references. See section I.D,
`supra. Upon consideration of the parties’ arguments and evidence, we determine
`that Pharmatech has demonstrated a reasonable likelihood that claims 1-3 are
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`and Schulmman. We
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`deny as re
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`Patent 77,250,105
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`unpatenntable as obbvious oveer Winarta
`
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`other chhallenges bbased on WWinarta.
`
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`1. OOverview off Winarta
`
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`
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`WWinarta desscribes a disposable GGOx-coateed electrodde test stripp used to
`
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`7:11-42.
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`calculatte glucose in a blood sample byy measurin
`g current.
`Ex. 1005,
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`Detail ffrom Figuree 2 of Winnarta is reprroduced beelow:
`
`
`
`dundant alll
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`
`de R, . Referencce electrod
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`TThe detail ffrom Figurre 2 shows
`the tip of aa test strip
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`trode ned in electre positionworkingg electrodee W, and psseudo-worrking electrrode W0 ar
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`area 26.. Id. 8:63-67. All thrree electroodes are co
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`ated with aa reagent mmix that
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`
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`
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`includess GOx. Idd. 7:25-26, 28, 41-42. A fluid chhannel runns over the
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`electrodess,
`
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`
`
`
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`m the open and the electrodess are arrangged in the oorder R–WW–W0 from
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`end, so thaat
`n W0. Id. 5
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`
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`fluid enntering the strip flowss first over R, then WW, and then
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`5:59-62. Fllow
`
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`easuremennt. Id. 5:644-65.
`
`
`
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`a meter to at triggers acurrent thaonto W00 causes a
`begin a m
`
`
`measuremments may bbe taken
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`
`
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`trode, and ounter electsed as a coW0 alsoo may be us
`W0. Id. 6:1-
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`betweenn R and W
`10.
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`2. Annalysis
`
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`PPharmatechh argues that Winartaa discloses
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`
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`all limitatiions of claaim 1 exceppt
`
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`
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`(a) meaasuring an eelectric currrent at a ssecond worrking sensoor part, (b)) comparinng
`
`
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`
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`the elecctric currennt from eacch of the working sennsor parts tto establishh a differennce
`
`
`
`
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`
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`parametter; and (c)) giving ann indicationn of an erroor if the diffference paarameter iss
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`15
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`Case IPR2013-00247
`Patent 7,250,105
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`greater than a predetermined threshold. Pet. 42-46. Pharmatech argues that
`Schulman discloses all three missing limitations. Id. at 43, 45-46. With particular
`reference to the claim requirement that the first and second working sensor
`generate “substantially identical” quantities of charge carriers in the absence of an
`error condition, Pharmatech argues that Winarta Figure 2 shows that W and W0 are
`the same size, but that, even if they are not, it would have been obvious to make
`them the same size in order to take advantage of Schulman’s comparisons based on
`multiple measurements. Id. at 44-45 (citing Ex. 1024 ¶ 61).
`With regard to limitation (a), Pharmatech argues that, because Winarta
`describes W0 as capable of being used to take measurements, it would have been
`obvious to modify Winarta to do so in view of Schulman’s disclosure to use two or
`more sensors to confirm reliability of a measurement. Id. at 43, 45 (citing Wang
`Decl. ¶ 63). With regard to limitations (b) and (c), Pharmatech argues, as it did in
`the Nankai/Schulman challenge, that modifying Winarta to include these steps
`would have been nothing more than the application of a known technique to
`improve a similar device with predictable results. Id.
`LifeScan argues that Winarta uses W0 as nothing more than a trigger and in
`no way suggests using W0 to make a glucose measurement. Prelim. Resp. 20-22.
`LifeScan’s litigation expert states that a current measured from W0 at the trigger
`time point would not be proportional to glucose due to an “initial charging current”
`that occurs when the circuit through W0 is closed by the encroaching sample.
`Ex. 2001 ¶ 62.
`LifeScan also disputes Pharmatech’s argument that W and W0 are the same
`size. Prelim. Resp. 22 (citing Ex. 2001 ¶ 61, 64). LifeScan submits an annotated
`version of Winarta’s Figure 3, which is reproduced below:
`
`
`16
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`Case IPPR2013-002247
`
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`
`Patent 77,250,105
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`
`
`
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`
`
`
`LifeScaan’s annotaated versionn of Winarrta’s Figurre 3 purporrts to indicaate that W
`
`
`
`
`
`
`
`
`d the ine 27 and en scribe linds betweeextends between sscribe liness 27 and 288, W0 exten
`
`
`
`W. Id. LifeeScan arguues
`
`
`
`
`ller than Wright ennd of middlle layer 30, and that WW0 is smal
`ies
`
`
`
`
`
`sors would e two sensthan W, theis smaller tthat, beccause W0 i
`
`not generaate quantit
`as
`
`
`cal” in the absence oof an error
`condition,
`
`
`
`of chargge carriers “substantiially identi
`
`
`
`requiredd by the claaim. Id. LLifeScan allso argues
`
`skill in thee art
`
`
`that one off ordinary
`anted, con
`
`
`
`
`would nnot have coonsidered SSchulman bbecause it
`is an impla
`ntinuous
`
`
`monitorr. Id. at 233, 27-29.
`that W0 is
` capable o
`
`
`
`
`
`RRegarding llimitation ((a), we agrree with Phharmatech
`f
`that Wina
`
`
`
`
`being used to makke a glucosse measurement, and
`
`
`arta is sugggestive of thhis
`
`use in sttating that
`
`
`
`
`can be usetrode and counter electW0 can serrve as a co
`d in
`
`
`See Ex. 10005, 6:1-100. We agr
`
`
`
`
`measureements relaative to refference eleectrode R.
`
`
`
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`
`
`
`further wwith Pharmmatech thatt, given thaat Winartaa has two seensors cappable of
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`
`
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`making glucose mmeasuremennts, it would have beeen obviouss to make tthem the s
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`
`
`
`
`
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`size andd to use theem in the mmanner Schhulman disscloses in oorder to coonfirm
`
`uments thaat a
`
`
`
`
`
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`reliabiliity of a measurementt. We are uunpersuadeed by LifeSScan’s arg
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`
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`combination of WWinarta andd Schulmann would bee based on
`
`
` for hindsight rreasoning,
`
`
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`
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`the reassons explaiined abovee with referrence to thee combinatation of Nannkai and
`
`
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`
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`Schulmman. Dr. MMeyerhoff’ss statementt that a currrrent measuurement froom W0 at
`
`
`
`
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`
`
`
`
`ee
`
`ame
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`trigger ttime wouldd not be prroportionall to glucosee is irrelevvant; Winarrta disclosees
`
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`17
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`Case IPR2013-00247
`Patent 7,250,105
`
`taking measurements after a twenty-second delay, not immediately upon the
`trigger. See Ex. 1005, 3:67-4:4.
`We are not persuaded by LifeScan’s argument and its annotated Winarta
`Figure 3 that W and W0 are different sizes. Patent drawings generally are not to be
`relied upon for precise proportions of elements unless indicated as being to scale.
`In re Wright, 569 F.2d 1124, 1127 (CCPA 1977). Winarta’s Figure 3 is not
`indicated as being to scale, so it neither supports nor contradicts size equality.
`We agree as well with Pharmatech that Winarta discloses the limitations of
`claims 2 and 3, and that those claims would have been obvious over Winarta and
`Schulman for reasons similar to those given above. LifeScan’s arguments are
`directed to claim 1, and LifeScan does not address claims 2 and 3 with separate
`specific arguments. See, e.g. Prelim. Resp. 23, 27-29.
`For these reasons, Pharmatech has demonstrated a reasonable likelihood of
`prevailing on the ground of unpatentability of claims 1-3 as obvious over Winarta
`and Schulman.
`
`D. Remaining Grounds of Unpatentability
`
`Pharmatech alleges multiple alternative grounds of unpatentability in
`addition to those discussed above in detail. See list, supra at 6. Upon review of
`those alternative grounds, we conclude that they are redundant in light of the
`grounds on the basis of which we institute review.
`
`III. CONCLUSION
`
`For the foregoing reasons, we determine that Pharmatech has demonstrated
`that there is a reasonable likelihood of its proving unpatentability of claims 1-3 of
`the ’105 patent by a preponderance of the evidence.
`
`
`18
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`Case IPR2013-00247
`Patent 7,250,105
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`IV. ORDER
`
`For the reasons given, it is
`ORDERED that the Petition is granted as to claims 1-3 with respect to the
`
`following grounds:
`1. Unpatentability of claims 1-3 under 35 U.S.C. § 103(a) for
`obviousness over Nankai and Schulman; and
`2. Unpatentability of claims 1-3 under 35 U.S.C. § 103(a) for
`obviousness over Winarta and Schulman;
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter partes
`
`review of the ʼ105 patent is hereby instituted commencing on the entry date of this
`Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is hereby
`given of the institution of a trial;
`FURTHER ORDERED that all other grounds presented in Pharmatech’s
`
`petition are denied, and no ground other than those specifically granted above is
`authorized for the inter partes review as to claims 1-3; and
`FURTHER ORDERED that an initial conference call with the Board is
`
`scheduled for 1 PM Eastern Time on September 12, 2013. The parties are directed
`to the Office Trial Practice Guide, 77 Fed. Reg. 48756, 48765-66 (Aug. 14, 2012)
`for guidance in preparing for the initial conference call, and should come prepared
`to discuss any proposed changes to the Scheduling Order entered herewith and any
`motions the parties anticipate filing during the trial.
`
`
`
`
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`19
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`
`Case IPR2013-00247
`Patent 7,250,105
`
`FOR PETITIONER:
`
`William A. Rudy
`A. Justin Poplin
`LATHROP & GAGE LLP
`
`
`
`FOR PATENT OWNER:
`
`Dianne B. Elderkin
`Steven Maslowski
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`
`Gregory L. Diskant
`Kathleen M. Crotty
`PATTERSON BELKNAP WEBB &
`TYLER, LLP
`
`
`20

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