UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`PHARMATECH SOLUTIONS, INC.
`Petitioners
`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.
`
`ORAL HEARING
`Petitioner’s Demonstratives
`
`1
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`PHARMATECH SOLUTIONS, INC.
`Petitioners
`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.
`
`ORAL HEARING
`Petitioner’s Demonstratives
`
`1
`
`
`
`Claims 1-3 are invalid under§103(a)
`as obvious over Nankai and Schulman
`
`Claims 1-3 are invalid under§103(a)
`as obvious over Winarta and Schulman
`
`LifeScan does not address claims 2 & 3 with
`separate specific arguments
`
`Decision – Institution of Inter Partes Review (Paper 11), Page 19
`Reply to Patent Owner’s Response (Paper 17), Page 2
`
`2
`
`
`
`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 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.
`
`Claim 1 of ‘105 Patent, 1002-7
`
`3
`
`
`
`LifeScan repeatedly tried
`
`— and failed —
`
`to patent the test strip disclosed and claimed in the ‘105 Patent
`
`Parent Patent 6,733,655
`
`-claim 23 (pending 4/22/2002) was substantially identical to strip
`
`-rejected as anticipated
`
`-withdrawn 5/6/2003
`
`Application for ‘105 Patent
`
`-claim 17 (pending 6/9/2006) was substantially identical to strip
`
`-rejected as anticipated
`
`-withdrawn 1/10/2007
`
`Child Application 11/772,714
`
`-claim 17 (pending 7/2/2007) was substantially identical to strip
`
`-rejected as anticipated by Winarta
`
`-rejected as obvious in view of Nankai
`
`-application abandoned 4/2/2010
`
`Request for Inter Partes Review (Paper 1), Pages 7-8
`
`4
`
`
`
`Collateral estoppel
`
`LifeScan argued to the District Court and to the Federal Circuit that:
`
`“[E]xhaustion is inapplicable [to transfers of the meter alone]…
`because the meters do not embody the essential features of the
`‘105 Patent.”
`
`-LifeScan Scotland Ltd. v. Shasta Technologies LLC, 734 F.3d 1361, 1377 (Fed. Cir. 2013)
`
`Reply (Paper 17), Pages 8-11
`
`5
`
`
`
`Collateral estoppel
`
`The Federal Circuit found that exhaustion applies, rejecting LifeScan’s argument
`that the strips were the “inventive features” of the claims, and noted:
`
`“a biosensor with multiple electrodes was known in the prior art, as LifeScan’s own expert
`admitted.”
`
`-LifeScan, 734 F.3d at 1369.
`
`“Here, strips with two working electrodes were disclosed by the prior art. The fact that the
`prior art strips might have required some reconfiguration to use with LifeScan’s meters is
`irrelevant. There is no suggestion that prior art strips with two working electrodes could not
`be easily configured to work with meters performing a comparing function.”
`
`-LifeScan, 734 F.3d at 1372-73.
`
`LifeScan repeatedly tried (and failed) to patent the strips alone (as discussed above), and
`“[h]aving accepted the rejection of its claims drawn to the strips themselves by abandoning
`those claims in both its original and continuation applications, LifeScan cannot now argue
`that the strips themselves were the invention.”
`
`-LifeScan, 734 F.3d at 1371.
`
`Reply (Paper 17), Pages 8-11
`
`6
`
`
`
`Collateral estoppel
`
`The Federal Circuit necessarily found that the test strip elements of the
`‘105 patent were in the prior art when it “conclude[d] that Shasta has
`established a patent exhaustion defense as a matter of law”
`
`-Lifescan, 734 F.3d at 1367
`
`The Federal Circuit rejected LifeScan argument that “exhaustion is
`inapplicable [to transfers of the meter alone]…because the meters do
`not embody the essential features of the ‘105 Patent.”
`
`-LifeScan, 734 F.3d at 1377
`
`The Federal Circuit did not need to reach the validity issue before the
`USPTO
`
`•
`
`“Because we conclude that Shasta has established a patent exhaustion defense
`as a matter of law, we reverse the grant of a preliminary injunction without
`reaching other issues in this case.” LifeScan, 734 F.3d at 1367
`
`Reply (Paper 17), Pages 8-11
`
`7
`
`
`
`Nankai – measuring device
`
`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 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;
`
`Claim 1 of ‘105 Patent, 1002-7
`Nankai, 1003-11
`
`8
`
`
`
`Nankai – measuring device
`
`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
`
`“downstream” has been properly construed to mean
`“further along a stream from its source”
`
`-supported by Wang declaration (1024-9 at ¶25)
`(“Nankai…discloses a test strip…that includes
`all of the features of the measuring device of
`claim 1, except it does not explicitly place the
`reference sensor upstream of the working
`sensor parts”)
`
`Request for Inter Partes Review (Paper 1), Page 16
`Decision – Institution of Inter Partes Review (Paper 11), Pages 9-10
`Nankai, 1003-11
`
`9
`
`
`
`Nankai – measuring device
`
`a reference sensor part upstream from said first and
`second working sensor parts
`
`repositioning was “obvious to try”
`
`-Wang declaration (1024-9 at ¶25)
`
`“…the shape of the space is not limited to those
`shown in the figures, likewise the shape or
`arrangement of the electrode systems.”
`
`-Nankai (1003-18 at 8:50-52)(emphasis added)
`
`“The two working sensor parts may be arranged as
`convenient within the device…”
`
`-‘105 Patent (1002-5 at 3:36-37)
`
`Request for Inter Partes Review (Paper 1), Page 16
`‘105 Patent, 1002-5
`Nankai, 1003-11, 18
`
`10
`
`
`
`Nankai – measuring device
`
`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;
`
`“substantially unidirectionally” properly construed
`to not require a single path
`
`-supported by Wang declaration (1024-9 at ¶25
`and Wang exhibit 17)
`
`Request for Inter Partes Review (Paper 1), Page 16
`Decision – Institution of Inter Partes Review (Paper 11), Page 9
`Nankai, 1003-11
`
`11
`
`
`
`Nankai – applying and measuring
`
`applying the sample liquid to said measuring device;
`
`-Nankai (1003-18 at 8:25-30)
`
`measuring an electric current at each working sensor part proportional to
`the concentration of said substance in the sample liquid;
`
`-Nankai (1003-18 at 8:11-14, 8:30-46)
`
`Request for Inter Partes Review (Paper 1), Page 20
`Decision – Institution of Inter Partes Review (Paper 11), Pages 9-10
`Nankai, 1003-18
`
`12
`
`
`
`Schulman —
`compare and give error indication
`
`comparing the electric current from each of the
`working sensor parts to establish a difference
`parameter; and
`
`-Schulman (1007-15, 23 at 3:17-28, 20:36-54)
`
`giving an indication of an error if said difference
`parameter is greater than a predetermined
`threshold.
`
`-Schulman (1007-15, 23 at 3:17-28, 20:62-64)
`
`Request for Inter Partes Review (Paper 1), Page 16
`Reply (Paper 17), Page 7
`Schulman, 1007-15, 23
`
`13
`
`
`
`Winarta — measuring device
`
`Winarta
`
`‘105 Patent
`
`excerpt from FIG. 2
`
`‘105 Patent, 1002-2
`Winarta, 1005-3
`
`19
`
`
`
`Winarta — measuring device
`
`a second working sensor part…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;
`
`Winarta’s first and second sensor parts W, Wo are
`constructed in the same manner, include the same
`reagent, and are arguably the same size
`
`-Winarta (1005-3, 10, 11, 12 at 5:37-54, 7:11-42,
`9:4-12, FIG. 2)
`
`Even if W and Wo are not the same size, one of
`ordinary skill in the art would have altered the sizing
`to arrive at a uniform size. Why? Because Wo is
`capable of taking the same measurement as W, and
`one would want to take advantage of the Schulman
`disclosure of taking multiple measurements and
`performing comparison functions.
`
`-Wang declaration (1024-20, 21 at ¶61, 63, 65)
`
`excerpt from FIG. 2
`
`Request for Inter Partes Review (Paper 1), Pages 43-45
`Winarta, 1005-3, 10, 11, 12
`
`20
`
`
`
`PATENT
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Phannatech Solutions, Inc.
`
`Petitioners
`
`V.
`
`Lifescan Scotland Ltd.
`
`Patent Owner
`
`Case IPRZOI3-00247
`
`Patent 7,250,105
`
`CERTIFICATE OF SERVICE UNDER 37 C.F.R. § 42.6(e)(3)
`
`1of2
`
`
`
`The undersigned certifies that on May 12, 2014, a copy of the Oral
`
`Hearing Petitioner’s Demonstratives, and Certificate of Service Under 37
`
`C.F.R. § 42.6(e)(3) were mailed by Express Mail bearing sufficient postage
`
`to:
`
`Dianne Elderkin
`
`Steven Maslowski
`
`Akin Gump Strauss Hauer & Feld, LLP
`Two Commerce Square, 415‘ Floor
`2001 Market Street
`
`Philadelphia, PA 19103
`
`Respectfully Submitted,
`
`By
`
`
`
`\
`.
`._
`A. Justin Poplin, Reg. No. 53,476
`LATHROP & GAGE LLP
`
`2345 Grand Boulevard, Suite 2400
`
`Kansas City, Missouri 64108
`Tel: (913)451-5130
`Fax: (813) 292-2001
`
`2of2
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