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Case Title

Inter Partes Review of U.S. Pat. 7,250,105

Docket Number

IPR2013-00247

Court

Patent Trial and Appeal Board

Document Title

Institution Decision 11: Decision 42108

Date Filed

08/15/2013
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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









Case IPR2013-00247
Patent 7,250,105


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.

2







Case IPPR2013-002247




Patent 77,250,105



C. The ’1055 Patent

C T

s







The ’105 paatent relatees to monittoring the llevel of a ssubstance iin a liquid,







particullarly the levvel of gluccose in bloood. Ex. 10002, 1:7-100. A glucoose assay is









performmed by inseerting a test strip intoo a meter annd then appplying a drrop of bloood to



the test strip. Id. 55:14-25. TThe test str
ip is made



from layeers of varioous materiaals,



built upp on a plasttic base andd capped wwith a coveer. Id. 4:355-5:14. Figgure 2 is






reproduuced beloww:



s arbon ink isattern of cawhich a past strip, in wr of the tesFigure 22 illustrates one layer












Id. 4:23-224. The caarbon ink fforms threee



screen-pprinted ontto the test sstrip base.







tracks 44, 6 (not labbeled), andd 8 (not labbeled), alonng the stripp, as well aas a







connectting bridgee 10. Id. 4::44-51. Eaach track hhas a conneecting termminal 4a, 6aa, 8a





at one eend of the sstrip and ann electrodee 4b, 6b, 8bb at the othher end. Idd. A layer
of







glucosee oxidase (““GOx”) is printed onn the electroodes. Id. 44:65-66. VVarious othher




of







layers aare depositeed to definne the rest oof the struccture, suchh as the preecise sizes

the elecctrodes andd a flow patth for the bblood. Id.




4:54–5:144.

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Case IPR2013-00247
Patent 7,250,105

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

4







Case IPR2013-00247
Patent 7,250,105


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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Case IPR2013-00247
Patent 7,250,105


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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Case IPR2013-00247
Patent 7,250,105

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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Case IPR2013-00247
Patent 7,250,105

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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Case IPR2013-00247
Patent 7,250,105

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:

9







Case IPPR2013-002247




Patent 77,250,105


d 1 on whichh is formed








FFigure 12 shhows a gluucose sensoor having bbase plate






lead 3 aand correspponding coounter electtrode 5, annd leads 21

, 22, and 223, and

correspoonding meeasurementt electrodess 41, 42, annd 43. Id.
pacer 7




8:5-10. S



the spacerr provides aa conduit ffor a




overliess the base pplate, and sspace 8 cutt out from





blood saample to fllow from inntroducingg port 10 too the meas


urement annd counterr







electroddes. Id. Abbstr., 8:15-18. Coverr 9 providees dischargge ports 11,, 12, and 1
3,





throughh which air leaves spaace 8 as it iis displaceed by the fllowing blo
od. The



measureement elecctrodes are coated witth GOx. Idd. 5:1, 8:1
ood

1-14. Duriing use, bl











enters thhrough thee introducinng port andd flows aloong the maain conduitt of space 88,








with portions of thhe sample entering suuccessive bbranches aalong the mmain conduuit.





Id. 8:255-27. A current meassurement iss made at eeach senso


r, and the mmeasuremeents


are averraged to give a final rresult. Id. 8:42-46.




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Case IPR2013-00247
Patent 7,250,105


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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Case IPR2013-00247
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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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Case IPR2013-00247
Patent 7,250,105

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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Case IPR2013-00247
Patent 7,250,105

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


14





Case IPPR2013-002247



and Schulmman. We

deny as re




Patent 77,250,105




unpatenntable as obbvious oveer Winarta



other chhallenges bbased on WWinarta.


1. OOverview off Winarta





WWinarta desscribes a disposable GGOx-coateed electrodde test stripp used to


7:11-42.




calculatte glucose in a blood sample byy measurin
g current.
Ex. 1005,





Detail ffrom Figuree 2 of Winnarta is reprroduced beelow:



dundant alll


de R, . Referencce electrod




TThe detail ffrom Figurre 2 shows
the tip of aa test strip










trode ned in electre positionworkingg electrodee W, and psseudo-worrking electrrode W0 ar




area 26.. Id. 8:63-67. All thrree electroodes are co


ated with aa reagent mmix that






includess GOx. Idd. 7:25-26, 28, 41-42. A fluid chhannel runns over the

electrodess,






m the open and the electrodess are arrangged in the oorder R–WW–W0 from

end, so thaat
n W0. Id. 5





fluid enntering the strip flowss first over R, then WW, and then

5:59-62. Fllow


easuremennt. Id. 5:644-65.




a meter to at triggers acurrent thaonto W00 causes a
begin a m


measuremments may bbe taken




trode, and ounter electsed as a coW0 alsoo may be us
W0. Id. 6:1-

betweenn R and W
10.

2. Annalysis


PPharmatechh argues that Winartaa discloses





all limitatiions of claaim 1 exceppt








(a) meaasuring an eelectric currrent at a ssecond worrking sensoor part, (b)) comparinng








the elecctric currennt from eacch of the working sennsor parts tto establishh a differennce








parametter; and (c)) giving ann indicationn of an erroor if the diffference paarameter iss


15





Case IPR2013-00247
Patent 7,250,105

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





Case IPPR2013-002247




Patent 77,250,105










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.







further wwith Pharmmatech thatt, given thaat Winartaa has two seensors cappable of







making glucose mmeasuremennts, it would have beeen obviouss to make tthem the s







size andd to use theem in the mmanner Schhulman disscloses in oorder to coonfirm

uments thaat a






reliabiliity of a measurementt. We are uunpersuadeed by LifeSScan’s arg





combination of WWinarta andd Schulmann would bee based on


for hindsight rreasoning,







the reassons explaiined abovee with referrence to thee combinatation of Nannkai and







Schulmman. Dr. MMeyerhoff’ss statementt that a currrrent measuurement froom W0 at









ee

ame

trigger ttime wouldd not be prroportionall to glucosee is irrelevvant; Winarrta disclosees


17





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





Case IPR2013-00247
Patent 7,250,105

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.






19





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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