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
`
` Paper No. ___
` Date Filed: Nov. 15, 2013
`
`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 PATENT OWNER RESPONSE
`PURSUANT TO 37 C.F.R. § 42.120
`
`
`
`
`
`
`
`
`
`
`
`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
`
` Paper No. ___
` Date Filed: Nov. 15, 2013
`
`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 PATENT OWNER RESPONSE
`PURSUANT TO 37 C.F.R. § 42.120
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION ........................................................................................... 1
`
`OVERVIEW OF THE ‘105 PATENT ............................................................ 2
`
`A. Diabetes/Blood Glucose Monitoring ..................................................... 2
`
`B.
`
`C.
`
`D.
`
`Electrochemical Reactions On The Test Strip ...................................... 3
`
`The Invention Claimed In The ‘105 Patent ........................................... 6
`
`Claims 1-3 of The ‘105 Patent ............................................................ 10
`
`III. THE BOARD DECISION INSTITUTING INTER PARTES REVIEW ....... 13
`
`IV. PERSON OF ORDINARY SKILL IN THE ART ........................................ 13
`
`V.
`
`SUMMARY OF ARGUMENT ..................................................................... 14
`
`VI. THE PRIOR ART RELIED ON BY PHARMATECH FAILS TO
`TEACH ALL OF THE CLAIM ELEMENTS .............................................. 17
`
`A. Nankai Fails To Teach Or Suggest The Test Strip Configuration
`And The Method Steps Called For By The ‘105 Patent Claims ......... 17
`
`1.
`
`2.
`
`3.
`
`Nankai does not place a reference sensor part upstream
`from the working sensor parts ................................................... 17
`
`Nankai does not disclose making multiple measurements
`and comparing them to a difference threshold .......................... 18
`
`Nankai fails to address the issue of inadequate sample
`size ............................................................................................. 19
`
`B. Winarta Fails To Teach Or Suggest A Second Working Sensor
`Part/Electrode For Measuring A Substance ........................................ 21
`
`1. Winarta’s teaching of using W0 as a counter electrode in
`a three-electrode system in no way suggests using it as a
`working electrode ...................................................................... 22
`
`
`
`
`
`2. Winarta’s teaching of using W0 to measure sample
`resistance does not teach using it as a working electrode ......... 24
`
`3. Winarta’s teaching of W0 as a trigger does not teach
`using it as a working electrode.................................................. 24
`
`4.
`
`One of ordinary skill in the art would not have been
`motivated to modify W0 to make glucose measurements ......... 25
`Schulman Fails To Teach Or Suggest A Method for
`Determining Blood Glucose Concentration As Claimed in the
`‘105 Patent ........................................................................................... 26
`
`C.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`Overview of implantable, continuous monitoring devices
`as disclosed in Schulman .......................................................... 26
`
`Schulman uses the term “sensor” differently than the way
`it is used in the ‘105 Patent ....................................................... 28
`
`Schulman does not use a disposable test strip to which
`liquid sample is applied. ........................................................... 30
`
`Schulman does not use the same “fundamental
`technique” as Nankai ................................................................ 30
`
`Schulman does not use a single measuring device
`comprising first and second working sensors (electrodes)
`each of which generates charge carriers in proportion to
`the concentration of substance in the liquid sample. ................ 31
`
`Schulman does not teach a second working electrode to
`make a second, independent measurement of glucose ............. 32
`
`Schulman does not teach comparing the electric current
`from W1 and W2 because each electrode measures
`something different ................................................................... 34
`
`Schulman fails to teach a “measuring device” with
`multiple “sensor parts” as that term is used in the ‘105
`Patent ......................................................................................... 34
`
`
`
`ii
`
`
`
`VII. THE BOARD SHOULD FIND THE ‘105 PATENT CLAIMS
`PATENTABLE IN VIEW OF PHARMATECH’S CHALLENGES ........... 36
`
`A.
`
`B.
`
`Petitioner’s Burden Of Proof ............................................................... 36
`
`Pharmatech Has Not Met Its Burden Of Proving That The
`Claims Are Obvious In View Of Nankai And Schulman ................... 36
`
`1.
`
`2.
`
`The Combination of Nankai and Schulman Does Not
`Suggest Every Element of the ‘105 Patent Claims ................... 37
`
`One of ordinary skill in the art would not have been led
`to combine Nankai and Schulman ............................................ 38
`
`C.
`
`Pharmatech Has Not Met Its Burden Of Proving That The
`Claims Are Obvious In View Of Winarta And Schulman .................. 43
`
`1.
`
`2.
`
`The combination of Winarta and Schulman fails to teach
`all the elements of the ‘105 Patent claims ................................ 44
`
`One of ordinary skill in the art would not have been led
`to combine Winarta and Schulman ........................................... 45
`
`VIII. SECONDARY CONSIDERATIONS ALSO SHOW THAT THE ‘105
`PATENT CLAIMS ARE NOT OBVIOUS ................................................... 45
`
`IX. SUMMARY ................................................................................................... 49
`
`X.
`
`CONCLUSION .............................................................................................. 52
`
`
`
`Appendix – List of Exhibits
`
`Certificate of Service
`
`
`
`iii
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`
`CASES
`
`Advanced Display Sys., Inc. v. Kent State Univ.,
`212 F.3d 1272 (Fed. Cir. 2000) .......................................................................... 46
`
`Bausch & Lomb, Inc. v. Barnes-Hind/Hydrocurve, Inc.,
`796 F.2d 443 (Fed. Cir. 1986) ............................................................................ 39
`
`Graham v. John Deere Co. of Kan. City,
`383 U.S. 1 (1966) ................................................................................................ 52
`
`Jazz Photo Corp. v. United States,
`439 F.3d 1344 (Fed. Cir. 2006) .......................................................................... 36
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 39, 52
`
`Leo Pharm. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) .......................................................................... 46
`
`Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH,
`139 F.3d 877 (Fed. Cir. 1998) ............................................................................ 39
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .......................................................................... 46
`
`Ruiz v. A.B. Chance Co.,
`234 F.3d 654 (Fed. Cir. 2000) ............................................................................ 46
`
`Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd.,
`492 F.3d 1350 (Fed. Cir. 2007) .......................................................................... 39
`
`STATUTES
`
`35 U.S.C. § 316 ........................................................................................................ 36
`
`iv
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`Pharmatech Solutions, Inc.’s (“Pharmatech”) Petition fails to establish that
`
`claims 1-3 of LifeScan Scotland Ltd.’s (“LifeScan”) U.S. Patent No. 7,250,105
`
`(“the ‘105 Patent,” Ex. 1002) are obvious. Accordingly, claims 1-3 should be
`
`deemed patentable over the cited art and the grounds instituted by the Patent Trial
`
`and Appeal Board in its August 15, 2013 Decision.
`
`The invention claimed in the ‘105 Patent is directed to a novel, innovative
`
`combination of a disposable test strip design and measurement method that
`
`addresses the long-known problem of insuring accuracy in blood glucose
`
`measurements. In addressing this problem, the ‘105 Patent discloses a disposable
`
`test strip having two working electrodes at which measurements of electric current,
`
`proportional to the concentration of glucose in a blood sample, are made. Those
`
`measurements are then compared to establish a difference parameter and, if that
`
`difference parameter is less than a predetermined difference, the glucose
`
`measurement is displayed to the user.
`
`Claims 1-3 of the ‘105 Patent claim this invention. The claims are not
`
`obvious over the combination of Nankai (Ex. 1003) and Schulman (Ex. 1007) or
`
`the combination of Winarta (Ex. 1005) and Schulman for several reasons. As
`
`explained below, and in the accompanying Declaration of John L. Smith (Ex.
`
`2008), each prior art combination fails to disclose or suggest at least one of the
`
`
`
`
`
`
`
`elements of the claims of the ‘105 Patent, and a prima facie case of obviousness
`
`has not been made. Moreover, even if one of ordinary skill in the art would have
`
`been motivated to modify the prior art to provide the missing elements (which they
`
`would not have been), there was no reason to combine the teachings of Schulman
`
`with either Nankai or Winarta. In the end, Pharmatech cannot meet its burden of
`
`showing that a person of ordinary skill in the art would have found the claimed
`
`invention obvious.
`
`II. OVERVIEW OF THE ‘105 PATENT
`A. Diabetes/Blood Glucose Monitoring
`Diabetes is a disease in which the body is unable to either manufacture or
`
`properly utilize insulin (Ex. 2008, Smith Decl. at ¶ 33). People with diabetes need
`
`to make frequent measurements of the amount of glucose in their blood to prevent
`
`both the chronic complications of high glucose levels (“hyperglycemia”) and the
`
`acute danger of low glucose levels (“hypoglycemia”) (id.). A variety of
`
`commercial blood glucose measurement systems, based on disposable test strips
`
`and the electronic meters with which they work, are available to make those
`
`measurements (id.). Obtaining accurate glucose measurements with these systems
`
`is critical because patients adjust one or both of their food intake and insulin doses
`
`based on the measurements (id.). Inaccurate measurements can have dire results
`
`for patients (id.).
`
`2
`
`
`
`
`
`In meter and test strip systems using electrochemical methods, the test strips
`
`contain chemical components that react with glucose in a blood sample to produce
`
`a current at an electrode and that current is proportional to the glucose
`
`concentration (id. at ¶ 21). The chemical components include an enzyme,
`
`frequently one called glucose oxidase, and a mediator that transfers electrons from
`
`the enzyme to the electrode (id.).
`
`To use such a system, a patient inserts a disposable test strip into the meter.
`
`The user then obtains a small drop of blood, usually from a finger, with a lancet.
`
`That drop of blood is applied to the strip, and the meter then determines the blood
`
`glucose level in the blood by measuring the electrical current produced. Other
`
`electronic circuitry and computer chips in the meter convert this current to a
`
`glucose value that is displayed to the user.
`
`Electrochemical Reactions On The Test Strip
`
`B.
`There are a number of reactions that occur on an electrochemical test strip,
`
`which may be summarized by the following figure from Dr. Smith’s expert
`
`declaration (id. at ¶ 23):
`
`
`
`3
`
`
`
`
`
`
`
`As depicted in the reactions across the top of Figure E at the working
`
`electrode, the glucose in the blood sample is oxidized to form gluconic acid by the
`
`enzyme glucose oxidase (id. at ¶ 24). As that is occurring, electrons are transferred
`
`from glucose to the enzyme and the enzyme is converted to a reduced form (id.).
`
`The reduced form of the enzyme then transfers electrons to the oxidized form of
`
`the mediator, converting it to the reduced form while the enzyme is simultaneously
`
`converted back to its oxidized form (id.). The reduced form of the mediator is then
`
`oxidized at the working electrode as it transfers electrons to the working electrode
`
`surface, causing current to flow in an external circuit (id.). As a result of the
`
`4
`
`
`
`
`
`sequence of reactions, the amount of current flowing in the external circuit is
`
`proportional to the glucose concentration (id.).
`
`There is also a complementary reaction that occurs at the counter (or
`
`counter/reference) electrode on the test strip. As shown in the bottom reaction on
`
`Figure E, electrons are transferred to oxidized mediator molecules, converting
`
`them to a reduced from of the mediator and completing the circuit (id. at ¶ 25).
`
`Thus, as the reduced mediator produced by the oxidation of glucose is oxidized at
`
`the working electrode, oxidized mediator is reduced at the reference (or counter)
`
`electrode, providing the complementary electrochemical reaction at the other
`
`electrode to complete the circuit (id. at ¶ 26). Both the enzyme and the mediator
`
`participate in the reaction at the working electrode as catalysts—materials that
`
`assist in carrying out a chemical reaction, but which are continuously recycled and
`
`not consumed in the reaction (id.). In contrast, glucose is consumed in the reaction
`
`(id.).
`
`In order to cause the electrochemical reaction to occur, a voltage that is
`
`specific to the substance being measured must be applied to the electrode (id. at ¶
`
`17). The reference electrode is configured to establish a reference point against
`
`which the voltage applied at the working electrode can be determined (id.). When
`
`the proper voltage is applied, current will flow in the circuit which is proportional
`
`to the concentration of the substance being measured (id.).
`
`5
`
`
`
`
`
`C. The Invention Claimed In The ‘105 Patent
`The ‘105 Patent is directed, generally, to the measurement of a substance,
`
`such as glucose, in a sample applied to a disposable test strip used in an
`
`electrochemical system as discussed above. Electric current is measured between a
`
`working electrode and a reference electrode, which the patent calls a “working
`
`sensor part” and a “reference sensor part” (Ex. 1002, ‘070 Patent at col. 1, lns. 27-
`
`29). The working sensor part comprises a layer of enzyme reagent, the current
`
`being generated by the transfer of electrons from the enzyme substrate, via the
`
`enzyme and an electron mediator compound, to the surface of a conductive
`
`electrode (id. at col. 1, lns. 29-33). The current generated is proportional to the
`
`concentration of glucose in the test sample (id. at col. 1, lns. 33-35; Ex. 2008,
`
`Smith Decl. at ¶ 34).
`
`The inventors of the ‘105 Patent recognized that inaccurate results can be
`
`obtained if the working sensor part is not fully covered with blood or if there is a
`
`manufacturing defect in, or damage has occurred to, the working sensor part (Ex.
`
`1002, ‘070 Patent at col. 1, lns. 39-64; Ex. 2008, Smith Decl. at ¶ 35). They also
`
`recognized the need to minimize the sample volume required for an accurate test
`
`(Ex. 1002, ‘070 Patent at col. 2, lns. 51-56; Ex. 2008, Smith Decl. at ¶ 35). With
`
`their invention, the inventors sought to achieve greater reliability and accuracy in
`
`glucose measurements by providing a way to (1) ensure that an adequate volume of
`
`6
`
`
`
`
`
`blood had been introduced to cover the entirety of the working sensor part of a test
`
`strip, and (2) ensure the working sensor parts were not defective due to
`
`manufacturing irregularities, while (3) not increasing the volume of blood required
`
`for testing (Ex. 1002, ‘070 Patent at col. 2, lns. 49-60; Ex. 2008, Smith Decl. at ¶
`
`35).
`
`The inventors achieved these goals, in material part, by providing on each
`
`disposable test strip two independent working sensor parts at which two separate
`
`current measurements could be carried out, placing a common reference electrode
`
`upstream of each of the two working sensor parts, and also placing the independent
`
`working sensor parts along the flow of the blood sample so that one of the working
`
`sensor parts can be completely covered before the other begins to be covered (Ex.
`
`2008, Smith Decl. at ¶ 35). In addition, they developed a method for using these
`
`strips in which the electric current measured at each of the working sensor parts is
`
`compared to establish a difference parameter, and an error is indicated if the
`
`difference parameter exceeds a predetermined threshold (id.).
`
`
`
`7
`
`
`
`
`
`An exemplary embodiment of the disposable test strip design that is used in
`
`the claimed method is depicted in Figure 2 of the ‘105 Patent below. Shown are
`
`the reference sensor part/ (on Element 4b) referred to as a “counter/reference
`
`sensor part” (Ex. 1002, ‘070 Patent at col. 4, ln. 45) and two working sensor parts
`
`where current measurements are made (on Elements 6b and 8b). Each of the
`
`working sensor parts is connected through conducting connectors (Elements 6a and
`
`8a) to separate current measuring circuits in a blood glucose meter (Ex. 2008,
`
`Smith Decl. at ¶ 36).
`
`
`
`
`
`
`
`
`
`Figure G
`
`8
`
`
`
`
`
`In Figure H (an enlargement of the top part of Figure 2), the conductive
`
`paths shown in Figure 2 are overlaid first with the insulating mask material shown
`
`as Element 12 in Figure 3. The insulating
`
`mask material (Element 12, shown in gray)
`
`is placed over the conductive traces in
`
`Figure H and coated with a layer of glucose
`
`oxidase enzyme (Element 14 from Fig. 4,
`
`shown in orange in Figure H) (id. at ¶ 37).
`
`The exposed areas that are defined by the
`
`opening in the insulating mask over the
`
`conductive material, and that are coated
`
`with the glucose oxidase enzyme, become
`
`Figure H. Enlarged top portion
`of ‘105 Patent Fig. 2, showing
`
`the two working sensor parts (shown as red rectangles in Figure H) where glucose
`
`is measured (id.). The reference sensor part area on element 4b is shown in blue in
`
`Figure H (id.).
`
`When a drop of blood is applied to the distal end (at the top of the
`
`rectangular strip as depicted in Figure H above), it flows along the channel in the
`
`strip, flowing across, in order, the sensor parts on elements 4b, 6b, and 8b (i.e., the
`
`reference sensor part and the two working sensor parts) (id. at ¶ 38). After a
`
`predetermined delay, the amount of current flowing in the two circuits connected
`
`9
`
`
`
`
`
`to the two sensor parts is measured and compared, and if the difference between
`
`the two currents is greater than a threshold difference parameter, the system reports
`
`an error condition (id.). A difference greater than the threshold could indicate (1)
`
`that not enough blood was introduced into the strip to completely cover the second
`
`working electrode, (2) that the two sensor parts were not of identical area, or (3)
`
`that there was a defect in or debris on one of the sensor parts that produced a
`
`difference in current (id.). Regardless of the cause, a test made in which the
`
`current difference between the two working sensor parts is greater than the
`
`threshold percentage is considered erroneous, and instead of a glucose
`
`concentration value, indication of an error is displayed to the user (id.). If the
`
`difference between the currents measured from the two working sensor parts is less
`
`than the predetermined threshold, the sum of the currents or the mean value of the
`
`currents may be converted to a glucose level by the measuring device (id.; Ex.
`
`1002, ‘070 Patent at col. 4, lns. 7-13 & col. 5, lns. 26-33).
`
`D. Claims 1-3 Of The ‘105 Patent
`Claims 1-3 of the ‘105 Patent (Ex. 1002) are as follows:
`
`1. The three claims in the ‘105 Patent are as follows:
`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:
`
`10
`
`
`
`
`
`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;
`
`11
`
`
`
`
`
`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 proportion to the concentration of
`glucose in the sample liquid.
`
`Although Claims 1-3 are method claims, the “providing” step recites a
`
`“measuring device” – specifically including, as recited in the last subpart of the
`
`“providing” step, a disposable test strip – having specific elements in a specific
`
`configuration. For the purpose of this submission, those claim elements may be
`
`referred to as the “test strip elements.”
`
`12
`
`
`
`
`
`III. THE BOARD DECISION INSTITUTING INTER PARTES
`REVIEW
`
`The Board granted review of claims 1-3 of the ‘105 Patent based on the
`
`following two grounds:
`
`• Alleged unpatentability of claims 1-3 under 35 U.S.C. §103 as obvious
`
`over Nankai (Ex. 1003) and Schulman (Ex. 1007); and
`
`• Alleged unpatentability of claims 1-3 under 35 U.S.C. §103 as obvious
`
`over Winarta (Ex. 1005) and Schulman.
`
`As explained below, neither of these two combinations of references
`
`discloses or suggests all of the elements recited in the ‘105 Patent claims and,
`
`moreover, one of ordinary skill in the art would not have been led to combine these
`
`prior art references. Accordingly, the patentability of claims 1-3 of the ‘105 Patent
`
`should be confirmed.
`
`IV. PERSON OF ORDINARY SKILL IN THE ART
`Neither Petitioner nor the Board offered a definition of the level of ordinary
`
`skill in the art.
`
`LifeScan’s Declarant, Dr. Smith, states that a person of ordinary skill in the
`
`art of the ‘105 Patent would have a bachelor degree in chemistry or electrical
`
`engineering, or an equivalent degree in the sciences or engineering fields (e.g.,
`
`physics or chemical engineering), and have experience working in the field of
`
`electrochemical glucose sensors for at least five years (Ex. 2008, Smith Decl. at ¶
`
`13
`
`
`
`
`
`13). Dr. Smith qualifies as a person of ordinary skill in the art and provided his
`
`opinions based on that perspective.
`
`V.
`
`SUMMARY OF ARGUMENT
`
`Claims 1-3 are not obvious over the combination of Nankai with Schulman
`
`or over the combination of Winarta with Schulman for several, independent
`
`reasons.
`
`As LifeScan understands the Board’s Decision, Nankai and Winarta are
`
`relied upon as allegedly relevant to the test strip claim elements, and Schulman is
`
`relied upon as allegedly relevant to the method step claim elements. But as
`
`explained below, and in the Smith Declaration (Ex. 2008), a person of ordinary
`
`skill in the art would not have found the claimed invention obvious over either of
`
`these two combinations of references.
`
`First, the cited references, even in combination, do not disclose each of the
`
`elements recited in the ‘105 Patent claims. Neither Nankai nor Winarta discloses
`
`or renders obvious a disposable test strip having all of the test strip elements
`
`recited in the ‘105 Patent claims:
`
`• Nankai does not disclose or suggest a test strip in which a reference
`
`sensor part is upstream of two working sensor parts.
`
`• Winarta does not disclose or suggest a test strip having two working
`
`sensor parts, and, accordingly, also does not disclose a test strip in
`
`14
`
`
`
`
`
`which a reference sensor part is upstream of two working sensor
`
`parts.
`
`Nor does either of Nankai or Winarta disclose or suggest the method steps
`
`required by the patent claims. Pharmatech and the Board appear to have
`
`appreciated this deficiency in Nankai and Winarta as each combined either Nankai
`
`or Winarta with an additional reference, Schulman, to try to show that the patent
`
`claims are obvious. But Schulman fails to disclose or suggest the method step
`
`elements missing in either Nankai or Winarta. Schulman’s continuous
`
`measurement system does not compare electric current readings from each of two
`
`working sensor parts to establish a difference parameter, or give an error indication
`
`if the difference parameter is greater than a predetermined threshold. In fact,
`
`current measurements made at the two working electrodes in the Schulman
`
`apparatus cannot be compared to one another because the two working electrodes
`
`do not measure the same thing ‒ one measures oxygen depletion caused by
`
`reaction of glucose with glucose oxidase and the other measures background
`
`oxygen.
`
` Second, even if the test strip claim elements could be found in the cited
`
`reference combinations (and they cannot), one of ordinary skilled in the art would
`
`not have been motivated to combine either Nankai or Winarta with Schulman to
`
`arrive at the claimed invention. The Board concluded that it would have been
`
`15
`
`
`
`
`
`obvious to combine Schulman with Nankai or Winarta because they all “are
`
`concerned with measuring blood glucose, and each uses the same fundamental
`
`technique of measuring GOx-mediated electrical current” (Decision at 13, 17). But
`
`as described below, Schulman does not use the “same fundamental technique” as
`
`Nankai or Winarta. Schulman teaches a method of measuring the consumption of
`
`oxygen during a reaction, and the method it uses to do so would be understood by
`
`one of ordinary skill in the art to be less accurate than anything taught in Nankai or
`
`Winarta. Thus, there would simply be no reason that one of ordinary skill in the
`
`art working in this area would have combined Schulman with either Nankai or
`
`Winarta absent the impermissible benefit of hindsight. Without a reason to
`
`combine the prior art, a claimed invention cannot be deemed obvious.
`
`Third, there is strong objective evidence of nonobviousness – namely,
`
`Pharmatech’s blatant copying of the test strips disclosed in and embodied by the
`
`‘105 Patent, for use in the method recited in the patent claims. Counsel for
`
`Pharmatech has admitted that the company copied the test strip design in
`
`LifeScan’s ‘105 Patent claims so that Pharmatech’s test strip can be used to
`
`practice the method steps of those claims in LifeScan’s One Touch® Ultra® meter.
`
`The Board should find that Pharmatech has failed to prove that claims 1-3 of
`
`LifeScan’s ‘105 Patent would have been obvious to one of ordinary skill in the art.
`
`16
`
`
`
`
`
`VI. THE PRIOR ART RELIED ON BY PHARMATECH FAILS TO
`TEACH ALL OF THE CLAIM ELEMENTS
`A. Nankai Fails To Teach Or Suggest The Test Strip
`Configuration And The Method Steps Called For By The
`‘105 Patent Claims
`1.
`
`Nankai does not place a reference sensor part
`upstream from the working sensor parts
`
`Nowhere in Nankai is there described the test strip configuration called for
`
`by the ‘105 Patent claims. The claims require “a reference sensor part upstream
`
`from said first and second working sensor parts . . .,” but Nankai, as Pharmatech
`
`rightfully admits, does not disclose a reference sensor (electrode) that is upstream
`
`from first and second working sensors (electrode) (Ex. 1024, Wang Dec. at ¶ 25).
`
`Pharmatech contends that “such configuration is merely an unpatentable
`
`rearrangement of parts” that provides no “benefit or unexpected result” (id.), and
`
`the Board stated in its Decision that Pharmatech’s position in this regard was
`
`“reasonable and supported by record evidence” (Decision at 12). But LifeScan
`
`respectfully submits that Pharmatech’s position is not reasonable.
`
`As Dr. Smith explains in his Declaration, there is indeed criticality to
`
`arranging the reference electrode upstream of the working electrodes (Ex. 2008,
`
`Smith Decl. at ¶ 43). Because the reference electrode in Nankai is placed
`
`downstream of the working electrodes, if insufficient blood is applied it will be the
`
`reference electrode rather than a working electrode that is incompletely covered
`
`(id.). Coverage of a minor portion of the reference electrode could cause a higher
`
`17
`
`
`
`
`
`than normal current density to flow in the covered part of the electrode, altering the
`
`ability of the reference electrode to provide a stable potential against which the
`
`working electrode could be established and potentially causing inaccurate
`
`measurements of glucose (id.). Nankai would not detect an inaccurate
`
`measurement made at any one of, or all of, the working electrodes; it would merely
`
`average the inaccurate measurement(s) (id.). Thus, Nankai does not recognize the
`
`criticality of placing the reference electrode upstream from the working electrode
`
`for obtaining accurate measurements (id.). Nor do Pharmatech’s Petition, or the
`
`Wang Declaration on which it relies, recognize this important issue.
`
`2.
`
`Nankai does not disclose making multiple
`measurements and comparing them to a difference
`threshold
`
`Another significant distinction between Nankai and the claims of the ‘105
`
`Patent is that Nankai does not teach or suggest the measurement method called for
`
`by the ‘105 Patent claims which includes comparing multiple, independent
`
`readings to an established difference parameter. Instead, Nankai averages the
`
`glucose reading taken from its multiple sensors/electrodes. The differences
`
`between Nankai’s averaging method and the claimed method are significant
`
`because, unlike the claimed method, Nankai’s method does not address the issue of
`
`improving accuracy by ensuring that sample covers the sensors or by dealing with
`
`the problem of potential sensor defects.
`
`18
`
`
`
`
`
` If an insufficient amount of sample is introduced to the Nankai strip, any
`
`one of the multiple electrode areas (shown, for example, in Figure 12) not filling
`
`completely with sample would cause an inaccurate result measured at that
`
`electrode (id. at ¶ 44). Similarly, if one or more of the electrodes in the Nankai
`
`strip suffered from a manufacturing defect or was damaged, an inaccurate result
`
`could be measured at that electrode. The inaccurate reading is not discarded, as it
`
`would be in the method claimed in the ‘105 Patent; it is averaged with the other
`
`readings and the resulting “average” is presented to the user (Ex. 1003, Nankai at
`
`col. 8, lns. 42-46). The resulting average of the three electrodes reported by the
`
`Nankai system would be less accurate than one, completely filled single electrode
`
`(Ex. 2008, Smith Decl. at ¶ 44).
`
`3.
`
`Nankai fails to address the issue of inadequate sample
`size
`
`There is no disclosure in Nankai of making individual measurements at each
`
`of the electrodes/sensors and comparing them
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