Case5:11-cv-04494-EJD Document215-1 Filed02/15/13 Page1 of 52
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`Gregory L. Diskant (admitted pro hac vice)
`Eugene M. Gelernter (admitted pro hac vice)
`Sean Marshall (admitted pro hac vice)
`PATTERSON BELKNAP WEBB & TYLER LLP
`1133 Avenue of the Americas
`New York, NY 10036
`Telephone: (212) 336-2000
`Facsimile: (212) 336-2222
`E-mail: gldiskant@pbwt.com
`emgelernter@pbwt.com
`smarshall@pbwt.com
`
`Richard Goetz (S.B. #115666)
`O'MELVENY & MYERS LLP
`400 South Hope Street
`Los Angeles, CA 90071-2899
`Telephone: (213) 430-6000
`Facsimile: (213) 430-6407
`E-Mail: rgoetz@omm.com
`
`Susan Roeder (S.B. #160897)
`O'MELVENY & MYERS LLP
`2765 Sand Hill Road
`Menlo Park, CA 94025
`Telephone: (650) 473-2600
`Facsimile: (650) 473-2601
`E-Mail: sroeder@omm.com
`
`Attorneys for Plaintiffs LIFESCAN, INC.
`and LIFESCAN SCOTLAND, LTD.
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`SAN JOSE
`
`LIFESCAN, INC. and
`LIFESCAN SCOTLAND, LTD.,
`
`v.
`
`Plaintiffs,
`
`SHASTA TECHNOLOGIES, LLC,
`DECISION DIAGNOSTICS CORP.,
`PHARMATECH SOLUTIONS, INC., and
`CONDUCTIVE TECHNOLOGIES, INC.,
`
`Defendants.
`
`Case No. 11-04494-EJD (PSG)
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`SUPPLEMENTAL DECLARATION
`OF MARK E. MEYERHOFF IN
`SUPPORT OF PLAINTIFFS'
`MOTION FOR A PRELIMINARY
`INJUNCTION
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`SUPP. DEC. OF MARK MEYERHOFF
`IN SUPPORT OF PI MOTION
`CASE NO. 11-04494-EJD (PSG)
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`LIFESCAN SCOTLAND LTD. EXHIBIT 2001
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`

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`Case5:11-cv-04494-EJD Document215-1 Filed02/15/13 Page2 of 52
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`Mark E. Meyerhoff, Ph.D., declares as follows:
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`1.
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`I am the Philip J. Elving Professor of Chemistry at the University of Michigan. I
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`have been retained by Plaintiffs LifeScan, Inc. and LifeScan Scotland, Ltd. as an expert on the
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`technical issues concerning the infringement and validity of U.S. Patent No. 7,250,105 (the '105
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`patent).
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`2.
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`I previously submitted a Declaration in this case, dated December 10, 2012, in
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`support of LifeScan's motion for a preliminary injunction. See D.E. 176-2. My earlier Declaration
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`discusses my qualifications (at ¶¶1-3). My curriculum vitae is attached to that Declaration as
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`Exhibit A.
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`3.
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`I submit this supplemental declaration to respond to assertions in the Declaration of
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`Defendants' expert, Dr. Joseph Wang, concerning the validity of claim 3 of the '105 patent and
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`concerning the infringement of that claim by the intended use of Defendants' GenStrip product with
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`LifeScan's OneTouch® Ultra® meters. As discussed below, it is my opinion that:
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`a)
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`the method described in claim 3 of the '105 patent would not have been
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`obvious at the time of the invention to persons of ordinary skill in the
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`relevant art;
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`b)
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`the specification of the '105 enables one of ordinary skill in the art to
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`practice the invention of claim 3 without undue experimentation, and the
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`invention of claim 3 has utility; and
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`c)
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`the electric current measured at each working sensor of the GenStrip is
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`"proportional to the concentration of [glucose] in the sample liquid," as that
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`phrase is used in the '105 patent.
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`SUPP. DEC. OF MARK MEYERHOFF
`IN SUPPORT OF PI MOTION
`CASE NO. 11-04494-EJD (PSG)
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`Case5:11-cv-04494-EJD Document215-1 Filed02/15/13 Page3 of 52
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`I.
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`SUMMARY OF OPINIONS
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`A.
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`Claim 3 of the '105 Patent Would Not Have Been Obvious
`I have reviewed Dr. Wang's Declaration. At the highest level, Dr. Wang asserts that
`4.
`it would have been obvious to combine one of two references (Winarta '2291 or Nankai '420) with a
`hodgepodge of other references in order to create the invention of the claims of the '105 patent.
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`5. Dr. Wang's analysis wholly fails to show that the invention of claim 3 of the '105
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`patent would have been obvious to a person of ordinary skill in the art. His Declaration ignores the
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`primary problems addressed by the '105 patent, ignores the level of ordinary skill in the relevant art,
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`relies completely on hindsight to puzzle together the cited references, ignores that the solutions
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`taught in the prior art to the problems addressed by the '105 patent differ significantly to the solution
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`claimed in the '105 patent, provides no reason why a person of ordinary skill in the art would have
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`combined the cited references, ignores that the PTO considered and rejected his arguments on
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`obviousness, and ignores "secondary considerations," which I understand to be crucial to the
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`analysis.
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`6. The claims of the '105 patent offer a simple, yet elegant solution to the existing
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`problems associated with reliability in glucose measurements using single-use disposable glucose
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`test strips at the time the patent was filed. Given the implications of inaccurate glucose readings
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`(i.e., for diabetics taking insulin, when they should not and vice versa), assurance of the reliability of
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`measurements in disposable glucose test strips is of critical importance.
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`7. The '105 patent sought to achieve greater reliability in disposable glucose test strip
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`measurements by providing a way to (1) ensure that an adequate volume of blood was covering the
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`entirety of the working electrode of a test strip and (2) ensure the electrodes were not defective either
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`due to manufacturing irregularities or user error, while (3) not increasing the volume of blood
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`required for testing. See ¶¶39-50, infra
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`1 Throughout this declaration, it is my convention to refer to a given patent by its first named author and the last 3 digits
`of the patent number.
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`2
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`SUPP. DEC. OF MARK MEYERHOFF
`IN SUPPORT OF PI MOTION
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`Case5:11-cv-04494-EJD Document215-1 Filed02/15/13 Page4 of 52
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`8. The '105 patent accomplished all three of these goals by providing a test strip where
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`the working electrode of the strip is divided into two working sensor parts. These parts are arranged
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`such that when blood is introduced to the test strip, the blood first traverses a reference electrode,
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`then traverses a first working sensor part and only then ultimately traverses a second working sensor
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`part. By utilizing this construction, there will not be a current generated on the second working
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`sensor part until after the blood has traversed the first working electrode. The patent then provides
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`for a method of comparing the current at the first sensor part with the current at the second sensor
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`part to see if those currents are substantially the same. If not, an indication of an error is given. See
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`Ex. 1, ('105 Patent) at Claim 1.
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`9. This solves the problem of ensuring that the working electrode is completely covered
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`because the only realistic way the current measured at the two working sensor parts would be the
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`same is if they are both completely covered. This is because the two electrodes have effectively the
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`same conductive areas. This also solves the problem of working electrode defects, because the only
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`realistic way the currents would be the same is if there was not something wrong with one or both of
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`the sensor parts. This is of utmost importance when relying on values of glucose concentration from
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`a single-use device, such as disposable glucose test strips, that cannot be checked by classical quality
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`control methods to ensure proper functionality prior to their use, as can be accomplished with
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`conventional, fully reversible, enzyme electrodes. And, finally, by splitting the working electrode
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`part into two, the amount of blood required for the measurement does not change. This simple
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`modification results in an innovative disposable test strip and measurement system that substantially
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`enhances the reliability of the system's measurements.
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`10. A strip that enabled such a comparison is not disclosed in any prior art reference
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`relied on by Dr. Wang or in any prior art reference that I have reviewed. See ¶¶57-83, infra. This is
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`fatal to Dr Wang's analysis because, in order to perform the method of the claims of the '105 patent,
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`one needs a test strip that has the design described in the claims of the '105 patent. Moreover, none
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`3
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`SUPP. DEC. OF MARK MEYERHOFF
`IN SUPPORT OF PI MOTION
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`Case5:11-cv-04494-EJD Document215-1 Filed02/15/13 Page5 of 52
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`of the prior art references in the disposable test strip art that Dr. Wang relies on provides the method
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`of electrode comparison. Indeed, none of the prior art identifies the specific problems that the '105
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`patent describes and addresses via an innovative approach. This is especially true in the context of
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`single-use glucose test strips that cannot be factory tested, or tested for functionality immediately
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`prior to patient use of the device.
`11. Dr. Wang's analysis does not consider whether a person of ordinary skill in the art2
`would have appreciated the problem of reliability that the inventors of the '105 patent recognized and
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`does not consider whether a person of ordinary skill in the art would have come to the innovative
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`solution claimed by the '105 patent. Instead, Dr. Wang's analysis focuses on whether persons with
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`an unidentified level of skill in the art could have located references that separately have elements of
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`the claims of the '105 patent and then pieced them together to create the invention claimed by the
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`'105 patent, while having the claims of the '105 patent with them to guide them along their way. See
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`¶¶84-95, infra. Dr. Wang's analysis considers whether one of skill in the art would have been
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`capable of creating the strip described in the methods of the '105 patent and performing the
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`comparison claimed by the '105 patent. This is, at core, a hindsight analysis and a different question
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`from whether it would have been obvious for a person of ordinary skill in the art to do so at the time
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`the ‘105 patent was filed.
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`12. Dr. Wang's analysis further fails to acknowledge that the solutions that the disposable
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`test strip art taught for improving reliability were different from the solution claimed by the '105
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`patent. There is nothing in the prior art that suggests that there are any problems with those earlier
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`solutions as to provide a motivation for a better solution. Rather, only the '105 patent's novel
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`approach of dealing with multiple problems provided the solution claimed in the '105 patent.
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`2 As set forth below in ¶33, in my opinion, a person of ordinary skill in the art of the '105 patent would have a bachelors
`degree in chemistry or electrical engineering, or an equivalent degree in the sciences/engineering fields (e.g., physics or
`chemical engineering), and have experience working in the field of electrochemical glucose sensors for at least five
`years.
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`SUPP. DEC. OF MARK MEYERHOFF
`IN SUPPORT OF PI MOTION
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`Case5:11-cv-04494-EJD Document215-1 Filed02/15/13 Page6 of 52
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`13. For example, the common approach to dealing with electrode coverage/adequate
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`blood sample volume was using a simple "trigger" that would identify when a blood sample had
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`reached a certain portion of the test strip. See ¶¶97-101, infra. This solution was viewed as
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`satisfactory in the art and thus did not create a motivation for a better solution. However, it could
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`not ensure the electrode was, in fact, entirely covered (just that it was covered in some amount) and
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`also provided no protection against defects in the electrode during manufacturing or shipment.
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`Further, this method wasted both test strip "real estate" (because the trigger needed to be placed
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`somewhere) and blood from the sample (because blood was needed to reach the trigger but that
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`blood was not used in the measurement).
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`14. Meanwhile, the common approach to dealing with improving measurement precision
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`from strip to strip was to add more and more electrodes to the strip and then average the results of
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`the plurality of electrodes. See ¶¶102-103, infra. Again this solution was viewed as satisfactory in
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`the art and thus did not create a motivation for a better solution. However, it did not account for
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`whether all of the electrodes were covered with adequate blood volume and additionally required
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`larger blood samples in order to cover all of the electrodes. Further, this "averaging" approach also
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`ran the risk that the measurement provided would be based in part on inaccurate data, if, for
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`example, one of the multiple electrodes was insufficiently covered by sample or was damaged in
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`some way.
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`15. The solution provided by the claims of the '105 patent is an improvement over the
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`prior art that balances the desire to use a small blood sample with the desire to increase reliability in
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`measurements.
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`16. Because of the failure of the disposable test strip art to provide the solution claimed
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`in the '105 patent and because Dr. Wang ignores the problems the '105 patent sought to solve, his
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`analysis also relies on art from fields a person of ordinary skill in the art would have never
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`considered. Specifically, Dr. Wang relies heavily on references relating to continuous-monitoring
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`SUPP. DEC. OF MARK MEYERHOFF
`IN SUPPORT OF PI MOTION
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`Case5:11-cv-04494-EJD Document215-1 Filed02/15/13 Page7 of 52
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`sensors. Continuous-monitoring sensors presented very different problems than those posed by
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`disposable strip sensors, and in particular, presented none of the problems that the '105 patent sought
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`to solve. See, ¶¶109-117, infra.
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`17. For example, because continuous-monitoring sensors are actually immersed fully in
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`the sample they are measuring (e.g., in the blood stream or in the subcutaneous fluid), they did not
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`present problems related to having a sufficient sample size. For the same reason, continuous-
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`monitoring sensors did not present any reason to deal with the constraint of a requiring an adequate,
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`albeit tiny, blood sample size that disposable test strips need to handle. Indeed, pricking one’s finger
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`can frequently not provide the minimal blood volume required to obtain accurate blood glucose
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`concentrations from disposable test strip devices. Therefore, there would not have been any reason
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`for a person of ordinary skill in the art to look to the continuous-monitoring sensor art to solve a
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`problem related to sample size adequacy when developing new single-use test strip devices.
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`18. Similarly, because continuous-monitoring sensors are reusable, they can be tested for
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`reliability beforehand, whereas disposable test strips are no longer useful once used, and therefore
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`testing beforehand is not feasible. Any reliability testing related to continuous-monitoring sensors is
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`done for a different reason - to identify when a given sensor's useful life has ended. Thus, there
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`would not have been any reason to look at continuous-monitoring sensor art to solve a problem
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`related to initial sensor integrity.
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`19. Even if a person of ordinary skill in the art were to have consulted these references,
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`or any of the references identified by Dr. Wang, the combination of those references would not result
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`in the invention of the '105 patent. See, ¶¶118-129, infra. At its simplest, no art provides any reason
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`to construct a strip that enabled the comparison of signals from two nearly-identical working sensor
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`parts of the '105 patent.
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`20. In addition, Dr. Wang's arguments are cumulative of those that were presented to the
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`Patent Office during the '105 patent's prosecution. Five of the ten references identified by Dr. Wang
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`SUPP. DEC. OF MARK MEYERHOFF
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`Case5:11-cv-04494-EJD Document215-1 Filed02/15/13 Page8 of 52
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`were already considered by the Patent Office. With respect to the other five references, Dr. Wang's
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`assertions are no different than those already considered by the Patent Office. See ¶¶130-135, infra.
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`21. Finally, Dr. Wang completely ignores secondary considerations of nonobviousness.
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`Such considerations provide real-world objective evidence of nonobviousness and are especially
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`relevant where, as here, an accused infringer makes arguments based on hindsight. In this case,
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`secondary considerations such as the extraordinary commercial success of products practicing the
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`'105 patent and Defendants' decision to capitalize upon that success by exactly copying the invention
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`claimed in the '105 patent strongly support my opinion that these claims are not obvious. See ¶¶136-
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`145, infra.
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`22. In sum, it is my opinion that the invention claimed in the '105 patent would not have
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`been obvious to a person of ordinary skill in the relevant art. None of the references identified by
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`Dr. Wang teaches or would have rendered it obvious to a person of ordinary skill to construct a strip
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`that enables the comparison of signals from two nearly-identical working sensors, as claimed by the
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`'105 patent. No reference teaches or would have rendered it obvious to a person of ordinary skill to
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`perform such a comparison in order to detect defective electrodes and insufficient sample size
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`problems. As a result, the method of the '105 patent would not have been obvious to a person of
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`ordinary skill in the art.
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`B.
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`The Invention of Claim 3 is Enabled by the Specification and Has Utility
`23. Contrary to Defendants' arguments, the claim limitation "measuring an electric
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`current at each working sensor part proportional to the concentration of [glucose] in the sample
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`liquid," is accurate, operable, and easily understood by one skilled in the art. The '105 patent's
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`specification describes the general principle that measured current is proportional to the amount of
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`glucose in the sample and cites prior art patents standing for the same proposition. The scientific
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`literature describes, frequently, the same principle using the same terminology as the '105 patent. I
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`believe the claims of the '105 patent are enabled and useful, meeting the validity requirements of 35
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`7
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`U.S.C. §§ 101 and 112 as they have been described to me by LifeScan's attorneys. See ¶¶146-159,
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`infra.
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`C.
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`Use of the GenStrip With a OneTouch® Ultra® Meter Infringes Claim 3
`24. As described in my previous declaration in support of LifeScan's motion for a
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`preliminary injunction, use of the GenStrip with a OneTouch® Ultra® Meter infringes claim 3 of the
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`'105 patent by meeting each and every claim limitation.
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`25. In response, Defendants only challenge one of the claim elements: they contend that
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`the electric current measured at each working sensor of the GenStrip is not "proportional to the
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`concentration of [glucose] in the sample liquid." Defendants' argument is based on a strictly
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`mathematical reading of the words "measured" and "proportional" that is inconsistent with the
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`specification of the '105 patent and the ordinary understanding of these terms in the field. See ¶¶16-
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`165.
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`26. In addition, Defendants essentially admit to meeting this claim limitation in their own
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`documents. The GenStrip's Instructions For Use state the following:
`TEST PRINCIPAL [sic]
`Glucose in blood combines with an enzyme in the test strip. This
`produces an electric current in the Meter in proportion to the glucose
`level. The Meter converts the current flow into a glucose reading on
`the Meter. The GenStrip test strip gives results calibrated to plasma.
`This allows direct comparison with laboratory results. Ex. 2 at
`PHARM0005237 (emphasis added).
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`II.
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`PRINCIPLES OF VALIDITY
`27. To the extent that I rely upon legal standards for the purposes of rendering the
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`opinions set forth herein or in my earlier declaration, I do so based on information from counsel for
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`LifeScan regarding such standards. I have been informed by counsel for LifeScan that independent
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`claims are read separately to determine their scope. Dependent claims include the limitations of the
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`claim from which they depend (e.g., another independent or dependent claim). To determine the
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`scope of a dependent claim, it must be read together with the claim or claims upon which it depends.
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`Case5:11-cv-04494-EJD Document215-1 Filed02/15/13 Page10 of 52
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`A.
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`Anticipation
`28. I have been informed that a patent claim must be novel under 35 U.S.C. § 102. I
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`have been informed that anticipation (lack of novelty) is established only when a single prior art
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`reference clearly and convincingly discloses each and every element of the claimed invention. I
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`have also been informed that under the principle of "inherency," anticipation by inherent disclosure
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`is appropriate only when a single prior art reference discloses subject matter that must necessarily
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`include the unstated limitation.
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`29. It is my understanding that Defendants do not allege that any single piece of prior art
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`discloses every limitation of any claim of the '105 patent, i.e., Defendants do not contend that any
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`single prior art reference anticipates any claim of the '105 patent. Defendants thus agree with my
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`assessment that the invention of the '105 patent is novel in the art.
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`B.
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`Nonobviousness
`30. I have been informed that the defense of obviousness is established only when it is
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`clearly and convincingly shown that "the subject matter as a whole would have been obvious at the
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`time the invention was made to a person having ordinary skill in the art." 35 U.S.C. § 103. I have
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`been informed that the determination of obviousness is based on four inquiries: (a) the scope and
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`content of the prior art; (b) the differences between the prior art and the claims at issue; (c) the level
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`of ordinary skill in the pertinent art; and (d) objective evidence of secondary considerations. I have
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`also been informed that examples of such secondary considerations of nonobviousness can include
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`the following: (1) commercial success; (2) long felt but unmet needs; (3) the failure of others; (4)
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`skepticism by those in the field; (5) praise for the invention; (6) recognition of a problem; (7)
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`copying of the invention; (8) commercial acquiescence; (9) other relevant factors. I have been
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`informed that there must be a nexus between the secondary consideration(s) of nonobviousness and
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`the claimed invention.
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`31. I have also been informed that in order for prior art references to be combined to
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`render a patent claim obvious, there needs to be some showing of the reason why a person of
`9
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`SUPP. DEC. OF MARK MEYERHOFF
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`CASE NO. 11-04494-EJD (PSG)
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`ordinary skill in the art would have combined the references in the manner asserted. I have also
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`been informed that hindsight alone is not sufficient to render the combination of two prior art
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`references obvious. Further, I have been informed that an infringer asserting invalidity cannot
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`simply use hindsight gleaned from the patent to pick and choose among individual parts of assorted
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`prior art to piece together the claimed invention. Additionally, I have been informed that the inquiry
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`on obviousness must be made from the perspective of a hypothetical person having ordinary skill in
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`the relevant art.
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`C.
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`Enablement and Utility
`32. I have been informed that patent claims must be "enabled" under 35 U.S.C. § 112,
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`such that the patent's specification adequately discloses to one skilled in the relevant art how to carry
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`out the claimed invention without undue experimentation. I have also been informed that 35 U.S.C.
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`§ 101 mandates that any patentable invention be useful, and according to the subject matter of the
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`claim, be operable. When an impossible limitation, such as a nonsensical method of operation, is
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`embodied within the claim, the claimed invention is invalid under 35 U.S.C. §§ 101 and 112. I have
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`also been informed that it is defendants' burden to show that patent claims are invalid under 35
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`U.S.C. §§ 101 or 112 by clear and convincing evidence.
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`III.
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`THE LEVEL OF ORDINARY SKILL IN THE ART
`33. In my opinion, a person of ordinary skill in the art of the '105 patent would have a
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`bachelors degree in chemistry or electrical engineering, or an equivalent degree in the
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`sciences/engineering fields (e.g., physics or chemical engineering), and have experience working in
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`the field of electrochemical glucose sensors for at least five years.
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`IV.
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`CLAIM CONSTRUCTION
`34. I have been informed that the claims of the '105 patent have still not yet been
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`construed, but that the parties have exchanged proposed constructions for certain terms and phrases
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`of the '105 patent claims.
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`CASE NO. 11-04494-EJD (PSG)
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`35. I understand that Defendants contend that the phrase "in proportion to the
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`concentration of said substance in the sample liquid" should be construed to mean "in a fixed ratio to
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`the concentration of the substance in the sample liquid." Ex. 3 at 8. And, that they contend that the
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`phrase "measuring an electric current at each working sensor part proportional to the concentration
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`of said substance in the sample liquid" should be construed to mean "the electric current measured at
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`each working electrode is in a fixed ratio to the concentration of the substance in the sample liquid."
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`Id. at 14.
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`36. As I describe more fully below (¶¶146-159), Defendants' contention provides a
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`strictly mathematical definition for the terms "in proportion" and "proportional." That definition is
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`unconventionally narrow as those terms would be used in the field; and so I disagree with their
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`proposed definition. My opinions herein and those set forth in my previous declaration rely on a
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`definition of "in proportion" and "proportional" as those terms are conventionally used in the art and
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`in many references regarding known glucometers.
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`37. I further understand that Defendants contend that the definitions "measuring device"
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`and "sensor" include "a device which applies an electrical current." Ex. 3 at 4-5. I assume that is an
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`error because all devices in the field apply an electric voltage, not an electrical current; I, therefore,
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`disagree with their proposed definition. My opinions herein and those set forth in my previous
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`declaration rely on an understanding of "measuring device" consistent with how that term would be
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`interpreted in the art, such as "a device for measuring." My opinions herein and those set forth in my
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`previous declaration rely on an understanding of "sensor" consistent with how that term is used in
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`the patent (see, Ex. 1, ('105 Patent) at 1:29-38) and would be interpreted in the art, such as
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`"conductive electrode with an overlayer of enzyme reagent rendering it suitable for electrochemical
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`measurement."
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`38. For all other terms, my opinions herein and those set forth in my previous declaration
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`would remain the same under any reasonable interpretation of the claim language.
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`V.
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`THE PROBLEMS SOLVED BY THE '105 PATENT
`39. The '105 patent is entitled "Measurement of Substances in Liquids." The application
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`for the '105 patent was filed on May 7, 2003, and the patent issued on July 31, 2007. It is a
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`continuation of the application that led to U.S. Patent No. 6,733,655, filed on March 8, 2000. Ex. 1,
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`('105 Patent). For purposes of considering obviousness, I have used March 8, 2000 as the relevant
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`date of the invention.
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`40. The '105 patent is directed towards an apparatus and method "for measuring the
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`concentration of a substance in a liquid and particularly, but not exclusively, to apparatus for
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`measuring the concentration of glucose in blood." Id. at 1:7-10.
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`41. The patent states that the accuracy of such devices for measuring glucose "is very
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`important since an inaccurate reading could lead to the wrong level of insulin being administered [to
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`a diabetic patient/individual] which could be harmful." Id. at 1:15-18.
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`42. Because "in all practical blood glucose measuring systems at least part of the device,
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`i.e. that part which comes into contact with the sample blood [a test strip] is disposable … it is
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`particularly important that the cost particularly of any disposable parts [test strips] can be minimised
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`as a user will generally need large numbers of them regularly." Id. at 1:19-24.
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`43. The patent states that glucose measuring devices function by measuring electric
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`current "between two sensor parts [of a given test strip] called the working and reference sensor
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`parts respectively." Id. at 1:28-29. The test strip's "working sensor part comprises a layer of enzyme
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`reagent, the current being generated by the transfer of electrons from the enzyme substrate, via the
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`enzyme and an electron mediator compound to the surface of a conductive electrode." Id. at 1:29-
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`33. The current generated by the test strip's working sensor "is proportional to both the area of the
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`sensor part and also the concentration of glucose in the test sample." Id. at 1:34-35.
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`44. One of the problems in the test strip art that the patent sets out to solve is "that
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`inaccurate results are obtained if the working sensor part is not fully covered with blood since then
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`its effective area is reduced." Id. at 1:39-41. If the working sensor was not covered fully, but
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`electrical connectivity by the sample to the reference electrode still occurred, the level of glucose
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`monitored would be falsely low, creating great risk to the patient using the device. Previous
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`methods of dealing with this problem involved using an electrode downstream of the working sensor
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`part (i.e., a trigger) to detect the presence of the sample liquid. Id. at 1:41-48.
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`45. Another way to solve the problem of incomplete coverage of the working sensor
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`would be simply to reduce the size of the working sensor part. Id. at 1:49-52. This however "tends
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`to give a greater variability in calibrated results." Id. at 1:52-54.
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`46. The inventors of the '105 patent "realised that as well as incomplete coverage of the
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`working sensor part, inaccurate results can also arise from occasional defects in the production of the
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`test strips for such devices, in the area and/or the thickness of the working sensor part and also from
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`accidental damage to the working sensor part e.g. by a user." Id. at 1:55-60. And since these type
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`of sensors cannot be tested in advance, either by the manufacturer, or the user, the possibility of
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`defects yielding inaccurate results are real and potentially life threatening to patients with diabetes.
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`47. The object of the invention described in the '105 patent was to create a test strip and
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`method for analyzing such a test strip that would overcome the problems described in the previous
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`paragraphs. Id. at 1:65-2:27. The solution described in the '105 patent involves the use of a test strip
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`that has two substantially-identical, as much as possible via manufacturing methods, working sensor
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`parts that both generate an electric current in proportion to the concentration of a substance (e.g.
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`glucose) in a liquid (e.g. blood). Id. at 2:21-27. The inventors of the '105 patent recognized that
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`when one uses a test strip with two substantially-identical working sensors, when the blood sample is
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`applied to the test strip, one can compare the difference in the electric current generated at e