Paper No. ___
` Date Filed: July 17, 2013
`
`Filed on behalf of LifeScan Scotland Ltd.
`By: Dianne B. Elderkin (delderkin@akingump.com)
` Steven D. Maslowski (smaslowski@akingump.com)
` AKIN GUMP STRAUSS HAUER & FELD LLP
` Two Commerce Square
` 2001 Market Street, Suite 4100
` Philadelphia, PA 19103
` Tel: (215) 965-1200
` Fax: (215) 965-1210
`
`
`
`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
`________________
`
`
`
`LIFESCAN SCOTLAND LTD.’S PRELIMINARY RESPONSE
`
`
`
`
`
` Date Filed: July 17, 2013
`
`Filed on behalf of LifeScan Scotland Ltd.
`By: Dianne B. Elderkin (delderkin@akingump.com)
` Steven D. Maslowski (smaslowski@akingump.com)
` AKIN GUMP STRAUSS HAUER & FELD LLP
` Two Commerce Square
` 2001 Market Street, Suite 4100
` Philadelphia, PA 19103
` Tel: (215) 965-1200
` Fax: (215) 965-1210
`
`
`
`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
`________________
`
`
`
`LIFESCAN SCOTLAND LTD.’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND ............................................................................................. 2
`
`A.
`
`The Parties ............................................................................................. 2
`
`B. Diabetes/Blood Glucose Monitoring ..................................................... 2
`
`C.
`
`D.
`
`E.
`
`F.
`
`LifeScan’s And Petitioner’s Products ................................................... 5
`
`The ‘105 Patent ..................................................................................... 5
`
`Prosecution Of The ‘105 Patent ............................................................ 8
`
`The District Court Litigation ............................................................... 10
`
`III. CLAIM CONSTRUCTION – “PROPORTIONAL” .................................... 11
`
`IV. PETITIONER HAS NOT SATISFIED THE STATUTORY
`THRESHOLD FOR INSTITUTING INTER PARTES REVIEW ............... 14
`
`A.
`
`B.
`
`Standard For Granting Inter Partes Review ........................................ 14
`
`Petitioner Has Failed To Show A Reasonable Likelihood Of
`Prevailing On Grounds 1-13 ............................................................... 14
`
`1.
`
`Petitioner’s Prior Art ................................................................. 15
`
`a)
`
`Category 1: Nankai and Winarta .................................... 16
`
`(1) Nankai .................................................................. 17
`
`(2) Winarta ................................................................. 19
`
`b)
`
`c)
`
`Category 2: Say, Schulman, and Horii ........................... 23
`
`Category 3: Khazanie and Lichten ................................. 25
`
`2.
`
`Petitioner’s Conclusory Allegations On Obviousness Fail
`To Meet The Standard For Implementing Inter Partes
`Review ...................................................................................... 26
`
`i
`
`
`
`
`
`C.
`
`Petitioner’s Petition Is Based On The Very Same Arguments
`The PTO And A District Court Have Already Rejected ..................... 32
`
`1.
`
`2.
`
`3.
`
`Petitioner’s Test Strip Prior Art Was Considered By The
`Patent Office Or Is, At Best, Cumulative To Prior Art
`Considered By The Patent Office ............................................. 33
`
`Petitioner’s Method Steps Prior Art Was Considered By
`The Patent Office Or Is, At Best, Cumulative To Prior
`Art Considered By The Patent Office ....................................... 34
`
`All Of Petitioner’s Prior Art Was Considered By The
`District Court ............................................................................. 35
`
`V.
`
`CONCLUSION .............................................................................................. 36
`
`
`
`ii
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.107, Patent Owner LifeScan Scotland Ltd.
`
`(“LifeScan”) hereby submits this preliminary response to the Petition filed by
`
`Pharmatech Solutions, Inc. (“Petitioner”) on April 11, 2013 requesting inter partes
`
`review of claims 1-3 of U.S. Patent No. 7,250,105 (“the ‘105 Patent”). LifeScan
`
`requests that the Board deny inter partes review as to all grounds in the Petition
`
`since the Petition fails to demonstrate a reasonable likelihood of proving that any
`
`claim in the ‘105 Patent is unpatentable.
`
`The Petition rests on nothing more than conclusory and unsupported
`
`allegations as to why one of skill in the art would have purportedly combined a
`
`multitude of references (sometimes as many as five) to arrive at the claimed
`
`invention. It does little, if anything, to explain how one of skill in the art would
`
`even arrive at the claimed invention with the references in hand.
`
`Moreover, the ‘105 Patent claims have now been considered twice in view
`
`of the same basic prior art disclosures on which Petitioner now relies. Once was
`
`during prosecution in which the method claims were allowed over prior art
`
`showing test strips with sensors (like Nankai) and continuous measurement
`
`systems (like Schulman and Horii). The patentability of the ‘105 Patent was again
`
`considered recently by a district court in conjunction with a preliminary injunction
`
`motion brought by LifeScan. In opposing that motion, Petitioner relied on the
`
`
`
`
`
`
`
`exact same references and arguments it now proffers, but, coming to the same
`
`conclusion as the Patent Office that the claims define a patentable invention, the
`
`district court granted the preliminary injunction, ruling that Petitioner’s
`
`obviousness arguments were not likely to carry the day.
`
`Because Petitioner has not shown a reasonable likelihood of proving that any
`
`claim in the ‘105 Patent is obvious, its Petition should be denied in its entirety.
`
`II. BACKGROUND
`A. The Parties
`LifeScan Scotland Ltd. is a subsidiary of Diabetes Diagnostics, Inc., which
`
`is a subsidiary of LifeScan, Inc. LifeScan, Inc. is one of five companies that
`
`comprise the Johnson & Johnson Family of Diabetes Companies that provide
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`advanced products and services, professional and community education, and
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`advocacy and support to people living with diabetes and their families. LifeScan,
`
`Inc. is a world leader in blood glucose monitoring for both home and hospital use.
`
`According to its website, Petitioner claims to be a “distributor of
`
`prescription drug, prescription diagnostics, and home testing products in the United
`
`States.” See Pharmatech Solutions, http://www.pharmatechdirect.com/ (last visited
`
`July 17, 2013).
`
`B. Diabetes/Blood Glucose Monitoring
`Diabetes is a disease in which the body is unable to either manufacture or
`
`properly utilize insulin. By monitoring their level of blood glucose, usually
`
`2
`
`
`
`
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`multiple times a day, diabetic patients can determine if their blood glucose level is
`
`too low (hypoglycemia) or too high (hyperglycemia). If the blood glucose level is
`
`not in a satisfactory range, patients can adjust their medication and diet to keep
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`blood glucose fluctuations to a minimum, thereby eliminating the complications
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`associated with the disease.
`
`Blood glucose monitoring systems used by patients at home typically
`
`involve two components, a disposable test strip to which blood is applied and a
`
`meter to read the level of blood glucose from the blood on the test strip. The test
`
`strip has a working sensor (electrode) comprising an enzyme that reacts with
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`glucose in blood to generate a current. The glucose concentration of the blood can
`
`be determined by the meter, which measures the amount of current generated and
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`calculates the glucose concentration from that measurement.
`
`To use such a system, a patient will insert a disposable test strip into the
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`meter. The user will then obtain a small drop of blood, usually from a finger, with
`
`a lancet. That drop of blood will be applied to the strip and the meter will then
`
`determine the blood glucose level in the blood by measuring the electrical current
`
`produced. With a blood glucose reading from the meter in hand, the patient can
`
`then take any necessary actions in view of a level that is too high or too low.
`
`The accuracy of blood glucose monitoring systems is very important since
`
`an inaccurate blood glucose reading could lead to the wrong level of insulin being
`
`3
`
`
`
`
`
`administered, which could be very harmful. Ex. 1002 at col. 1:15-18. The
`
`inventors of the ‘105 Patent recognized issues with such systems that could lead to
`
`inaccurate readings. For one thing, inaccurate results can be obtained if the
`
`working sensor on the test strip is not fully covered with blood. Id. at 1:39-41. If
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`the working sensor is not covered fully, but a current is still measured, the level of
`
`glucose monitored would be falsely low, creating great risk to the patient using the
`
`device. Ex. 2001 at ¶ 44.1 Inaccurate results can also arise from occasional defects
`
`in the production of the disposable test strips, in the area and/or thickness of the
`
`working sensor part and also from accidental damage to the working sensor part,
`
`e.g., by a user. Ex. 1002 at 1:55-60. Since the single-use, disposable test strips
`
`cannot be tested in advance, either by the manufacturer or by the user, the
`
`possibility of defects yielding inaccurate results are real and potentially life
`
`threatening to diabetes patients. Ex. 2001 at ¶ 46.
`
`
`Consistent with the Board’s recent ruling in Anova Food, LLC. v. Leo
`1
`
`Sandau et al., IPR2013-00114 (PTAB June 25, 2013) (declaration testimony
`
`submitted in prior district court proceeding is not “new” testimony barred by 37
`
`C.F.R. § 42.107(c)), LifeScan submits with this Statement declaration testimony of
`
`Mark E. Meyerhoff (Ex. 2001) and Peter Menziuso (Ex. 2002), previously filed in
`
`the district court preliminary injunction proceedings.
`
`4
`
`
`
`
`
`C. LifeScan’s and Petitioner’s Products
`LifeScan, Inc. sells the OneTouch® Ultra® system of meters and specially
`
`designed, disposable test strips. It is the market-leading blood glucose monitoring
`
`system in the United States. Ex. 2002 at ¶¶ 5, 7. An important feature of the
`
`OneTouch® Ultra® system is that it checks each blood sample twice to promote
`
`accuracy in blood glucose measurements. LifeScan refers to this feature in
`
`promotional materials and on its website as its “DoubleSure™ Technology.” Id. at
`
`¶ 8. Use of the LifeScan Ultra® meter with LifeScan Ultra® test strips practices at
`
`least claims 1 and 3 of the ‘105 Patent challenged in the Petition. Ex. 2001 at ¶
`
`140.
`
`Petitioner offers a disposable test strip, called the GenStrip, for use with
`
`LifeScan’s OneTouch® Ultra® meters. Ex. 2002 at ¶¶ 17-20. A district court
`
`determined that the GenStrip is a “near exact” copy of the test strip from
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`LifeScan’s commercial OneTouch® Ultra® system. Ex. 2003 at 2-3, 15, 24-25;
`
`see also Ex. 2004 at 56:20-22 (Petitioner’s counsel: “If you want to have a strip
`
`that is going to work with the OneTouch Ultra system, you have to copy it.”).
`
`D. The ‘105 Patent
`
`Glucose monitoring systems using disposable, single-use test strips can
`
`provide inaccurate results if the sensors used for measurement are not completely
`
`covered with blood or if the test strips are damaged during manufacture or use. Ex.
`
`5
`
`
`
`
`
`1002 at col. 1:39-60. The inventors of the ‘105 Patent, recognizing that the
`
`industry needed better solutions to these problems, discovered a new and improved
`
`method for increasing the accuracy of such measurements.
`
`The ‘105 Patent addresses the problem of inaccurate readings by providing
`
`an innovative disposable test strip design and measurement method combination.
`
`The test strip design, the inner workings of which are shown in Figure 2 below,
`
`involves a reference sensor (4b) and two working sensors (6b and 8b), with the
`
`second working sensor (8b) downstream of the first working sensor (6b).
`
`
`
`
`
`Id. at Fig. 2 (labels and arrow added).
`
`Once a drop of blood is applied to the top of the strip, the blood will flow
`
`unidirectionally over the first working sensor 6b and then over the second working
`
`sensor 8b. Id. at col. 3:40-49. The working sensors will each generate an electric
`
`6
`
`
`
`
`
`current that “is proportional to both the area of the sensor part and also the
`
`concentration of glucose in the test sample.” Id. at col. 1:33-35. When the two
`
`working sensors are substantially identical (in material and size), the current
`
`generated by each should be substantially identical when both working sensors are
`
`fully covered with blood. Id. at col. 3:25-35.
`
`Measurements of the currents at the working sensor parts may then be taken
`
`and compared to one another. Id. at col. 3:31-35 & col. 5:26-33. If the difference
`
`in the measurements is below a pre-determined limit, both working sensors are
`
`operating properly and are covered by blood. Id. If the difference between the
`
`currents measured at the two working sensors is above a predetermined limit, an
`
`error message is displayed on the measuring device, the test strip is discarded, and
`
`the test must be repeated using an un-used test strip. Id.
`
`The claimed invention in the ‘105 Patent as described above directly
`
`addresses the problems that the prior art left unsolved. For example, with regard to
`
`inadequate sample size, the unidirectional flow of the test strip defined in the ‘105
`
`Patent claims ensures that, for a sample to provide a non-error result to the user,
`
`the sample must be large enough so that it covers the first working sensor followed
`
`by covering the second working sensor. In addition, the method of comparing the
`
`separate measurements taken from the first and second working sensors described
`
`in the claim ensures that both working sensors are equally covered with blood and
`
`7
`
`
`
`
`
`that they are functioning properly because, if they are not, the measurements from
`
`the two working sensors will be sufficiently dissimilar that an error message will
`
`result. As such, the unique and novel blood glucose monitoring system described
`
`in the ‘105 Patent provides enhanced accuracy and reliability in determining blood
`
`glucose levels in a patient.
`
`E.
`
`Prosecution of the ‘105 Patent
`
`The ‘105 Patent application was filed on May 7, 2003 as a continuation of
`
`application No. 09/521,163, filed on March 8, 2000, which is now Patent No.
`
`6,733,655. The ‘105 Patent issued on July 31, 2007 with three method claims.2
`
`During prosecution, the Examiner provided extensive discussion of the prior
`
`art. For example, the Examiner rejected claims 33-35, which were dependent on
`
`claim 17 and which later issued as claims 1-3, as obvious over Nankai in view of
`
`Horii. Ex. 2005 at 18-19; Ex. 1017 at 16-17. The Examiner’s rejection was
`
`essentially the same argument that Petitioner now sets out – that it would have
`
`Petitioner’s arguments about the prosecution of test strip claims (Petition at
`2
`
`7-9) are irrelevant as the claims in the ‘105 Patent at issue here are directed to
`
`methods, not test strips, and include, inter alia, steps of using specially configured
`
`test strips. Moreover, the prior art relied upon by the USPTO in rejecting test strip
`
`claims is deficient for rendering the allowed method claims obvious, for reasons
`
`described below. See also Ex. 2001 at ¶¶ 76-83.
`
`8
`
`
`
`
`
`been obvious to combine prior art disposable blood glucose test strip systems with
`
`disclosures from continuous-monitoring systems like Horii (and Say and
`
`Schulman) to arrive at the claimed invention. In this regard, the Examiner stated:
`
`Nankai discloses a device as set forth in claim 17. . . .
`
`Horii discloses a measurement device comprising several of the
`same electrochemical sensors. Horii further discloses using an
`average value of the measurement values from these sensors for
`computing the concentration of the substance of interest and also
`comprising [sic: comparing] the measurement values from the sensors
`to judge whether any of the sensors are abnormal. See the abstract
`and Figures 1 and 2. It would have been obvious to also compare the
`measured values from the sensor parts of Nankai to see if they are too
`different because this will indicate whether one of the sensor parts is
`not function [sic] correctly and so whether its measurement value
`should be excluded from the calculation of the substance
`concentration.
`
`
`Id.
`
`Following amendments to claim 17 to further distinguish the test strip
`
`configuration from the configuration shown in Nankai, the Examiner dropped the
`
`pending rejection of claims 33-35 in view of Nankai and Horii. Ex. 1019 at 8-9.
`
`The Examiner also provided a “statement of reasons for the indication of allowable
`
`subject matter” explaining how U.S. Patent No. 6,287,451 to Winarta (“Winarta
`
`‘451”), which discloses a test strip similar in structure to the Winarta patent
`
`discussed in Section IV.B.1(a) below, teaches away from claims 33-35:
`
`9
`
`
`
`
`
`Winarta [451] teaches away from having the working sensors
`arranged such that, in the absence of an error condition, the quantity
`of charge carriers generated by a first of the working sensor parts are
`substantially identical to the quantity of charge carriers generated by a
`second of the working sensor parts because the first working sensor
`part does not comprise an enzyme as does the second working sensor
`part and in fact the current response from the first working sensor part
`is subtracted from the current response from the second working
`sensor part to give a more accurate analyte measurement. See col.
`6:3-34
`
`Id. Applicants then canceled all claims other than 33-35 and the patent proceeded
`
`to issuance.
`
`F.
`
`The District Court Litigation
`
`Petitioner is one of four entities that LifeScan sued in the U.S. District Court
`
`for the Northern District of California for infringement of three LifeScan patents,
`
`including the ‘105 Patent. LifeScan added the ‘105 Patent to the litigation in
`
`December 2012 and immediately sought a preliminary injunction to prevent
`
`Petitioner and the other defendants from infringing the ‘105 Patent through their
`
`manufacture and sale of the generic GenStrip, intended for use with LifeScan’s
`
`OneTouch® Ultra® meters.
`
`In opposing LifeScan’s preliminary injunction motion at the District Court,
`
`Petitioner advanced the exact same invalidity arguments through the same expert,
`
`Dr. Wang, as now relied on in its Petition. More precisely, Petitioner argued that
`
`the ‘105 Patent claims were invalid based on various combinations of Nankai, Say,
`
`Winarta, Schulman, Yee, Khazanie, Lichten, Stewart, and Horii.
`
`10
`
`
`
`
`
`On March 19, 2013, the district court granted LifeScan’s preliminary
`
`injunction motion finding, inter alia, that LifeScan had shown a likelihood of
`
`overcoming the obviousness challenges to the ‘105 Patent. The court stated:
`
`Plaintiffs have rebutted Defendants’ obviousness evidence with
`compelling evidence and argument showing that the patent examiner
`considered many of the references cited by Defendants, that one of
`skill in the art would not necessarily have had reason to combine the
`known elements, that the prior art does not cover each and every
`limitation of Claim 3, and that Defendants improperly used hindsight.
`
`Ex. 2003 at 22. On April 29, 2013, the Court of Appeals for the Federal Circuit
`
`stayed the injunction pending Petitioner’s appeal to that court. The appeal was
`
`argued at the Federal Circuit on June 6, 2013.
`
`
`
`III. CLAIM CONSTRUCTION – “PROPORTIONAL”
`Petitioner has proposed that the claim terms “proportion” and “proportional”
`
`be construed to mean “correlated to.” LifeScan agrees.
`
`“Proportion” is used twice, and “proportional” once, in claim 1 of the ‘105
`
`Patent as highlighted below:
`
`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;
`
`
`
`11
`
`
`
`
`
`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 . . .
`
`
`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.
`
`Ex. 1002 at col. 6:52-col. 8:4. In addition, claim 3 uses the term “proportion” in a
`
`similar fashion as claim 1.
`
`According to the plain language of the claim, “proportion(al)” is used to
`
`describe the relationship that was known in the prior art between “the
`
`concentration of a substance [e.g., glucose] in the sample liquid” and: (a) “the
`
`charge carriers generated at [a] working sensor,” and (b) “the current measured at
`
`each working sensor part.” Id. In the context of the patent, “proportion(al)” refers
`
`to the known correlation between the concentration of a substance in the sample
`
`and the number of charge carriers that are generated and measured. Accordingly,
`
`the term should be construed as “correlated to.”
`
`The parties’ proposed construction of “proportion(al)” as “correlated to” is
`
`consistent with art in the glucose monitoring area. As analogous art, as well as art
`
`12
`
`
`
`
`
`that was cited during prosecution of the ‘105 Patent, these reference disclosures are
`
`relevant for claim construction. See In re Cortright, 165 F.3d 1353, 1359 (Fed.
`
`Cir. 1999) (using disclosures from analogous art to confirm claim construction);
`
`Powell v. The Home Depot, Inc., 663 F.3d 1221, 1231 (Fed. Cir. 2011) (prior art
`
`cited in a patent or cited in the prosecution history of the patent constitutes intrinsic
`
`evidence).
`
`For example, the specification of the ‘105 Patent discusses prior art
`
`disclosing “[k]nown glucose measuring devices,” including U.S. Patent No.
`
`5,582,697 to Ikeda. See id. at col. 1:25-44; Ex. 2006. Ikeda uses the term
`
`“proportion(al)” in the same sense as the ‘105 Patent – i.e., to mean “correlated to”
`
`– when it states that “[t]he obtained [i.e., measured] current value is in proportion
`
`to the concentration of the substrate in the sample liquid.” Ex. 2006 at col. 8:9-19.
`
`Similarly, U.S. Patent No. 5,820,551 to Hill is another prior art patent that
`
`shows the understanding of the plain and ordinary meaning of the term
`
`“proportion(al)” by persons skilled in the art. Like Ikeda, Hill uses
`
`“proportion(al)” as meaning a response that can be correlated with glucose
`
`concentration. See Ex. 2007 at col. 8:56-57. Thus, these prior art disclosures
`
`confirm the parties’ proposed construction.
`
`13
`
`
`
`
`
`Consistent with the ordinary meaning of “proportion(al)” and its use in the
`
`specification, the term “proportion(al)” in the ‘105 Patent should be construed to
`
`mean “correlated (to).”
`
`IV. PETITIONER HAS NOT SATISFIED THE STATUTORY
`THRESHOLD FOR INSTITUTING INTER PARTES REVIEW
`A.
`The Board’s authority to institute inter partes review is limited to only those
`
`Standard For Granting Inter Partes Review
`
`circumstances in which “the information presented in the petition . . . and any
`
`response . . . 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.” 35
`
`U.S.C. § 314(a); see also 37 C.F.R. § 42.108(c). The burden of showing that this
`
`statutory threshold has been met falls on Petitioner. See, e.g., Office Patent Trial
`
`Practice Guide, 77 Fed. Reg. 48,756 (Aug. 14, 2012) (“The Board . . . may institute
`
`a trial where the petitioner establishes that the standards for instituting the
`
`requested trial are met . . . .”). Petitioner has not met that burden.
`
`B.
`
`Petitioner Has Failed To Show A Reasonable Likelihood Of
`Prevailing On Grounds 1-13
`
`Petitioner fails to demonstrate that there is a reasonable likelihood that it will
`
`prevail with respect to at least one of the claims challenged in its Petition. Instead,
`
`Petitioner does nothing more than describe a multitude of prior art references and
`
`provide conclusory and unsupported allegations as to why the ‘105 Patent claims
`
`are allegedly obvious in view of various combinations of those references.
`
`14
`
`
`
`
`
`Because the Petition does not meet the necessary standard for implementing inter
`
`partes review, it should be denied in its entirety.
`
`Petitioner’s Prior Art
`
`1.
`The ‘105 Patent claims methods for measuring the concentration of a
`
`substance in a sample liquid in which the first step is providing a measuring
`
`device, such as a disposable test strip, having a specified structure and
`
`configuration. The remaining steps are method steps reciting applying the sample
`
`liquid to the measuring device, measuring electric current generated in the
`
`measuring device, and manipulating the current readings.
`
`Petitioner relies on three basic categories of prior art in its Petition. As the
`
`primary reference in each of its asserted grounds of invalidity, it relies on a
`
`reference from the first category – either Nankai or Winarta – in an attempt to
`
`show that the structure and configuration of the disposable test strips recited in the
`
`patent claims was known or obvious (“test strip prior art”).
`
`As secondary references, Petitioner relies on prior art from categories two
`
`and three in an attempt to show that the method steps recited in the patent claims
`
`were known or obvious (“method steps prior art”). The second category includes
`
`three references – Say, Schulman, and Horii – which do not relate to blood glucose
`
`monitoring through single use, disposable test strips, but instead are directed to
`
`devices used to continuously monitor substances such as blood glucose or ions in a
`
`15
`
`
`
`
`
`sample. The third category of prior art includes Khazanie and Lichten which are
`
`statistics textbooks.3
`
`Not only do the primary references fail to disclose the individual elements of
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`the disposable test strips recited in the ‘105 Patent claims, Petitioner offers no
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`evidence that a person of ordinary skill in the art to which the invention pertains
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`would have combined the test strip prior art with the method steps prior art to
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`arrive at the claimed invention.
`
`a)
`Nankai and Winarta relate to single-use, disposable test strips. Neither one,
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`Category 1: Nankai and Winarta
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`however, discloses the configuration of sensors provided for in the claims of the
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`‘105 Patent; nor do they disclose the method of comparing readings from such
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`sensors to improve accuracy (a fact as much as conceded by Petitioner by the fact
`
`
`3
`Petitioner relies on two other references, Yee and Stewart, in some of its
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`various combinations. With no explanation, Petitioner relies on Yee to purportedly
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`teach that “the arrangement of electrodes does not affect their characteristics,” and
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`Stewart to purportedly teach that “glucose meters typically used with disposable
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`test strips have electronic features designed to detect invalid test results and report
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`an error condition.” See, e.g., Pet. at 18, 33. Neither one is relied on by Petitioner
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`to teach any of the deficiencies pointed out in this paper.
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`16
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`
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`that it relies on secondary references in an attempt to show that those method steps
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`would have been obvious).
`
`(1) Nankai
`Nankai, relied upon as the primary reference in Petitioner’s Grounds 1-6,
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`describes its invention as a “disposable biosensor” that can be used to measure the
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`concentration of a substrate, such as glucose, in blood “rapidly in a simple
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`operation.” Ex. 1003 at col. 3:65-col. 4:4.
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`Nankai does not disclose an arrangement of working sensors, as recited in
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`the ‘105 Patent claims, where two working sensors are positioned downstream
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`from a reference sensor, where the second working sensor is positioned
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`downstream from the first working sensor, and wherein the liquid sample is
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`constrained to flow substantially unidirectionally across the reference sensor and
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`the first and second working sensors. Instead, Nankai teaches working sensors
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`(electrodes) that are parallel to one another and in which blood flows across
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`multiple, parallel systems. Ex. 2001 at ¶¶ 72-74; Ex. 1003 at Figs. 12 and 13. As
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`shown in Fig. 12 of the Nankai patent below (annotated with red lines indicating
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`direction of blood flow), the sample first passes over working electrodes 43, 42 and
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`41, each in a different parallel sample fluid path, and then reaches the
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`reference/counter electrode 5 last.
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`17
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`
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`Ex. 2001 at ¶ 74 (red arrows added). Since the Nankai sensor configuration does
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`not provide the unidirectional flow required by the ‘105 Patent claims, it does not
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`provide the advantage of the patented invention of ensuring that one of the sensor
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`parts will always be completely covered before the other sensor begins to be
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`covered, thereby avoiding the possibility that insufficient sample is applied to
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`cover both sensor parts. Ex. 1002 at col. 3:43-50.
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`Nor does Nankai disclose or suggest comparing multiple sensor readings to
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`determine a difference parameter, as the claims of the ‘105 Patent require. Pet. at
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`11. Instead, Nankai teaches a very different, and much less effective, way for
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`insuring accuracy. Nankai teaches that higher accuracy can be obtained by
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`“providing a plurality of electrode systems for the same sensor and obtaining a
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`mean value of the response levels.” Ex. 1003 at col. 8:42-46. In other words,
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`18
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`
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`Nankai teaches that multiple readings may be taken from the same sample on the
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`strip and, for increased accuracy, the mean or average of those readings should be
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`used to determine the blood glucose value displayed to the user. But averaging
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`multiple readings is an unsatisfactory solution to the problem of variable blood
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`glucose readings caused by either inadequate blood sample or manufacturing
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`defects, as averaging does not alert the user to one or more bad readings. Rather,
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`the bad readings are averaged with other readings, possibly leading to inaccurate
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`results.
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`Nankai neither discloses nor suggests the test strip configuration recited in
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`the ‘105 Patent claims, nor offers solutions to the problems of insufficient sample
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`and test strip defects that can lead to inaccurate results.
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`(2) Winarta
`Winarta, relied upon as the primary reference in Petitioner’s Grounds 7-11,
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`describes as its invention a “disposable electrode strip for testing a fluid sample.”
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`Ex. 1005 at [57]. Winarta, like Nankai, fails to teach the test strip configuration
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`and method steps set out in the ‘105 Patent claims.
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`With no explanation or support, Petitioner contends that “Winarta (‘229)
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`discloses placing the reference sensor part R upstream from the working sensor
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`parts, W, Wo and unidirectional flow . . . .” See, e.g., Pet. at 12. This overstates
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`Winarta’s disclosure. Winarta discloses only one working electrode (W) for
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`19
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`
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`measuring glucose. It discloses a “pseudo-working” electrode (Wo) that merely
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`“triggers the reading meter to start the measurement” which occurs at the single
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`working electrode. Ex. 2001 at ¶¶ 62-65; Ex. 1005 at col. 5:63-66.
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`The Winarta “trigger” embodiment is depicted in Figure 2:
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`
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`Ex. 1005 at Fig. 2. In use, the three layers of the test strip depicted above are
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`joined together and a drop of blood is placed at the tip of the test strip where the
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`channel cutout 32 begins. Referring to the figure in the bottom right hand corner
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`above, the test strip is designed such that blood is intended to flow in a direction
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`where it covers the reference electrode (R) first, then the working electrode (W)
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`which will ultimately make the blood glucose reading, and then the “trigger,”
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`referred to as the “pseudo-working electrode” (Wo) in the Winarta patent. Id. at
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`col. 5:59-62. Once contacted by the blood, the pseudo-working electrode in
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`20
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`Winarta “triggers the reading meter to start the measurement and analyte
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`concentration determination process.” Id. at col. 5:63-66. According to Winarta,
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`“[s]uch an arrangement obviates reliability and accuracy problems due to an
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`insufficient sample fluid si
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