EXHIBIT 1024:
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`DECLARATION OF DR. JOSEPH WANG DATED 4/9/2013. (“WANG DEC.”)
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`
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`Pharmatech Solutions, Inc.: EXHIBIT 1024
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`
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`DECLARATION OF DR. JOSEPH WANG DATED 4/9/2013. (“WANG DEC.”)
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`
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`Pharmatech Solutions, Inc.: EXHIBIT 1024
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
`
`
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Trial No.:
`In re Patent of:
`U.S. Patent No.:
`Issue Date:
`Serial No.:
`Filing Date:
`Title:
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`to be assigned
`Davies
`7,250,105
`July 31, 2007
`10/431,140
`May 7, 2003
`MEASUREMENT OF SUBSTANCES IN LIQUIDS
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`DECLARATION OF DR. JOSEPH WANG
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`I, Dr. Joseph Wang, declare:
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`1.
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`I am an adult individual and make this Declaration based on personal
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`knowledge.
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`2.
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`I have been retained by Pharmatech Solutions, Inc. (“Petitioner”) to
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`provide analysis regarding U.S. Pat. No. 7,250,105, and I am also serving as an expert
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`for Petitioner in related litigation Lifescan, Inc. v. Shasta Techs., LLC, 5:11-CV-
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`04494-EJD (N.D.Cal). I have personal knowledge of the facts set forth in this
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`Declaration unless otherwise stated. If called as a witness, I could and would
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`competently testify to the facts set forth in this Declaration.
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`________________________________________________________________________________
`DECLARATION OF DR. JOSEPH WANG
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`20128452v1
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`Pharmatech Solutions, Inc: 1024-1
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`Qualifications
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`3.
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`I am a Distinguished Professor in the Department of Nanoengineering at
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`the University of California, San Diego. I was awarded a D. Sc. From the Israel
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`Institute of Technology in 1978. I have authored over 900 research papers, am a
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`named inventor of ten patents, and have written 12 chapters and 9 books, including
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`Analytical Electrochemisty and Electrochemical Sensors, Biosensors And Their
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`Biomedical Applications. I received the American Chemical Society Awards for
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`Chemical Instrumentation and Electrochemistry in both 1999 and 2006. I have also
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`received the Institute for Scientific Information’s ‘Citation Laureate’ Award for being
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`the Most Cited Scientist in Engineering from 1991 to 2001. A copy of my curriculum
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`vitae and a list of selected publications (from over 900 peer reviewed papers) are
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`attached hereto as Exhibits 1 and 2. A copy of my article Electrochemical Glucose
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`Biosensors, 108 Chem Rev. 814 (2008) is attached hereto as Exhibit 3, and fully
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`incorporated by reference herein.
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`4.
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`Recently, I won the 2012 Breyer Medal of the Royal Australian Chemical
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`Institute, and the 2013 Spiers Memorial Award of the UK Royal Society of Chemistry,
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`which are awarded for internationally-recognized contributions in the field of
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`electrochemistry.
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`5.
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`I was named as an Honorary Professor at National University (Cordoba,
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`Argentina) in 2004, an Honorary Doctor Causa from Complutense University (Madrid,
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`Spain) in 2007, an Honorary Member of the Slovenia National Institute of Chemistry
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`_______________________________________________________________________________
`1
`DECLARATION OF DR. JOSEPH WANG
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`Pharmatech Solutions, Inc: 1024-2
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`in 2007, an Honorary Professor from University of Science Technology Beijing
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`(China) in 2011, an Honorary Doctor Causa of Alcala University (Spain) in 2011, and
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`a Nanyang Professor from NTU (Singapore) in 2008. I have served as a Fellow of the
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`American Institute for Medical and Biological Engineers and the Japan Society for the
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`Promotion of Science. In 1995 and 1997, I was the most cited electrochemist in the
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`world, and was recognized as the ISI’s “Most Cited Researchers in Chemistry” from
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`1997 to 2007.
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`Introduction
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`6.
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`Petitioner’s counsel has informed me that claims are construed differently
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`in the Patent Office than in litigation, that construction of a term in litigation has no
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`effect on how the term should be construed in the Patent Office, and vice versa.
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`Petitioner’s counsel has asked me to construe “proportion(al)” in the claims of the ‘105
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`Patent as “correlated to”, and the analysis and conclusions set forth herein use that
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`construction.
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`7.
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`At least for the reasons discussed below, I believe it is clear that claims 1-
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`3 of U.S. Patent No. 7,250,105 (“‘105 Patent”) are invalid as obvious under 35 U.S.C.
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`§ 103. For the sake of convenience, a copy of the ‘105 Patent is attached as Exhibit 4.
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`8.
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`In the early 1990’s, following the rising incidence of diabetes, disposable
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`glucose test strips were well developed. In simplified terms, test strips included an
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`electrode and a chemical composition that reacts with blood. When blood is
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`_______________________________________________________________________________
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`DECLARATION OF DR. JOSEPH WANG
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`20128452v1
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`Pharmatech Solutions, Inc: 1024-3
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`introduced to the strip, a chemical reaction occurs, causing current to pass from the
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`electrode through an electrical circuit. The amount of current can then be used to
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`calculate the concentration of glucose in the blood. To improve the test results, some
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`test strips used multiple electrodes and averaged readings together to obtain better
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`measurements of current. Some of the history of disposable test strips is described in
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`U.S. Patent No. U.S. Pat. No. 5,120,420 to Nankai (hereinafter “Nankai (‘420)”), a
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`copy of which is attached hereto as Exhibit 7.
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`The ‘105 Patent
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`9.
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`The ‘105 Patent, entitled “Measurement of Substances in Liquids” was
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`filed May 7, 2003, was issued July 31, 2007, and lists Oliver W. H. Davies as the first
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`named inventor. See Exhibit 4. It is a continuation of application 09/521,163 filed
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`March 8, 2000, which was later issued as U.S. Patent No. 6,733,655 (“‘655 Patent”).
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`A copy of the ‘655 Patent is attached hereto as Exhibit 5. I have reviewed the ‘105
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`Patent, the ‘655 Patent, the U.S. Patent & Trademark Office (“USPTO”) file for the
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`‘105 Patent, and the USPTO file for the ‘655 Patent.
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`10.
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`The ‘105 Patent claims are directed to a method for using a blood glucose
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`test strip with a test strip meter. After the ‘105 Patent was allowed (but before it was
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`issued), Lifescan filed a continuation patent application with the USPTO in an attempt
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`to expand the coverage of the ‘105 Patent. That continuation application was assigned
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`DECLARATION OF DR. JOSEPH WANG
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`20128452v1
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`Pharmatech Solutions, Inc: 1024-4
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`application number 11/772,714 (“the ‘714 Application”). A copy of relevant portions
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`of the USPTO file for the ‘714 Application is attached hereto as Exhibit 6.
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`11.
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`The ‘714 Application claimed the test strip from the ‘105 Patent, without
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`the associated method steps, and was rejected: (a) for “obviousness-type” double
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`patenting based on the ‘105 Patent; (b) as being both anticipated by and obvious in
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`view of U.S. Pat. No. 6,258,229 to Winarta (“Winarta (‘229)”), a copy of which is
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`attached hereto as Exhibit 8; and (c) as obvious in view of Nankai (‘420). See Exhibit
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`6, Oct. 2, 2009 Office Action, Non-Final Rejection.
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`12. Upon receiving these rejections, Lifescan abandoned the ‘714
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`Application. See Exhibit 6, May 5, 2010, Notice of Abandonment.
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`13. Consistent with the glucose test strips that came before it, the ‘105 Patent
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`notes that glucose measuring devices function by measuring electric current between at
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`least two sensor parts (working and reference sensor parts) of a given test strip. And
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`consistent with the prior devices, the working sensor part in the ‘105 Patent includes a
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`layer of enzyme reagent and a mediator such that reaction between the blood and
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`reagent causes a current to be generated at the electrode. I do not find anything that
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`suggests Lifescan considered these things to be new when the application was filed,
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`and I agree that this was well known long before the ‘105 Patent was filed. In fact, I
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`agree with the USPTO’s decision in the ‘714 Application that the entire test strip
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`disclosed in the ‘105 Patent and appearing in its claims is not patentable.
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`_______________________________________________________________________________
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`DECLARATION OF DR. JOSEPH WANG
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`20128452v1
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`Pharmatech Solutions, Inc: 1024-5
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`14.
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`The remainder of the ‘105 Patent is generally directed to a method of
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`measuring glucose concentration using the test strip that was found to be unpatentable
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`in the subsequent ‘714 Application.
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`The Claims of the ‘105 Patent are Invalid for Being Obvious
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`15.
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`Petitioner’s counsel has explained to me that a patent claim is invalid for
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`obviousness under 35 U.S.C. § 103 if the differences between the subject matter
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`sought to be patented and the prior art are such that the subject matter as a whole
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`would have been obvious at the time the invention was made to a person having
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`ordinary skill in the art to which said subject matter pertains.
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`16.
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`I have also been informed that various rationales may be used to find a
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`patent claim obvious. For example, a combination of familiar elements according to
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`known methods is likely to be obvious when it does no more than yield predictable
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`results. And when a work is available in one field, design incentives and other market
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`forces can prompt variations of it, either in the same field or in another. Rearranging
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`parts in a manner that does not change operation of the device is also not a patentable
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`improvement. And still further, where a skilled artisan merely pursues known options
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`from a finite number of identified, predictable solutions, the result was merely obvious
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`to try. Obviousness also exists when a claimed improvement is but a predictable use
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`of prior art elements according to their established functions.
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`17.
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`I have been further informed that to determine whether there was an
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`apparent reason to combine the known elements in the way a patent claims, it is often
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`_______________________________________________________________________________
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`DECLARATION OF DR. JOSEPH WANG
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`Pharmatech Solutions, Inc: 1024-6
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`necessary to look to interrelated teachings of multiple patents; to the effects of
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`demands known to the design community or present in the marketplace; and to the
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`background knowledge possessed by a person having ordinary skill in the art. In
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`addition, I understand that a validity analysis need not seek out precise teachings
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`directed to the specific subject matter of the challenged claim, as the inferences and
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`creative steps that a person of ordinary skill in the art would employ can be
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`recognized, and that the legal determination of obviousness may include recourse to
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`logic, judgment, and common sense.
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`18. As I describe in more detail below, it is my opinion that Claims 1, 2, and
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`3 of the ‘105 Patent are invalid as obvious.
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`Obviousness Ground 1
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`19.
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`It is my opinion that claim 1 is invalid under 35 U.S.C. § 103 as obvious
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`over Nankai (‘420) in view of U.S. Pat. No. 6,175,752 to Say (hereinafter, “Say
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`(‘752)”), a copy of which is attached hereto as Exhibit 9.
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`20. Nankai (‘420) discloses a test strip (or “measuring device”) that includes
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`all of the features of the measuring device of claim 1, except it does not explicitly
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`place the reference sensor upstream of the working sensor parts, as set forth in the
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`claim chart below. However, such configuration is merely an unpatentable
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`rearrangement of parts. According to the ‘105 Patent, the sensor parts may be
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`arranged in various configurations “as convenient”, and no benefit or unexpected
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`_______________________________________________________________________________
`6
`DECLARATION OF DR. JOSEPH WANG
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`20128452v1
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`Pharmatech Solutions, Inc: 1024-7
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`result is set forth for placing the reference sensor upstream of both working sensor
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`parts. See ‘105 Patent at col. 3, lines 36-58. Further, Nankai (‘420) specifically
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`teaches that the shape and arrangement of the sensors may vary. See Exhibit 7, Nankai
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`at col. 8, lines 47-52. So in any case, the claimed arrangement would be one of a finite
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`number of identified, predictable solutions having a reasonable expectation of success
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`(and thus obvious to try).
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`21. Nankai (‘420) also discloses applying the sample liquid to the measuring
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`device. See Exhibit 7, Nankai (‘420) at col. 8, lines 25-30. And Nankai further
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`teaches that multiple measurements should be taken and averaged together. Id. at col.
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`8, lines 11-14 and 30-46.
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`22.
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`Say (‘752) discloses that when readings are taken from multiple
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`electrodes, they should be compared to one another to identify errors. See Exhibit 9,
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`Say (‘752) at col. 39, lines 26-46; col. 40, lines 11 and 14-16. Incorporating this into
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`Nankai (‘420) would be nothing more than the use of a known technique to improve
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`similar devices/methods in the same way, and the results would be predictable. When
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`the comparison in Say (‘752) reveals that the difference in readings is outside a
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`predetermined threshold level, the patient is alerted that the sensor is defective. See
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`Exhibit 9, Say (‘752) at col. 39, lines 26-46 and col. 40, line 11. Alerting users of the
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`Nankai (‘420) device of defects would have been obvious in light of the teachings of
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`Say (‘752). This would nothing more than the use of a known technique to improve
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`similar devices/methods in the same way, and the results would be predictable.
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`_______________________________________________________________________________
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`DECLARATION OF DR. JOSEPH WANG
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`23. A claim chart showing application of Nankai (‘420) and Say (‘752) to
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`claim 1 is attached hereto as Exhibit 16, and is incorporated fully as if set forth herein.
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`Obviousness Ground 2
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`24.
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`It is my opinion that claim 1 is invalid under 35 U.S.C. § 103 as obvious
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`over Nankai (‘420) in view of U.S. Pat. No. 5,791,344 to Schulman (“Shulman
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`(‘344)”), a copy of which is attached hereto as Exhibit 10.
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`25. Nankai (‘420) discloses a test strip (or “measuring device”) that includes
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`all of the features of the measuring device of claim 1, except it does not explicitly
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`place the reference sensor upstream of the working sensor parts, as set forth in the
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`claim chart below. However, such configuration is merely an unpatentable
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`rearrangement of parts. According to the ‘105 Patent, the sensor parts may be
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`arranged in various configurations “as convenient”, and no benefit or unexpected
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`result is set forth for placing the reference sensor upstream of both working sensor
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`parts. See ‘105 Patent at col. 3, lines 36-58. Further, Nankai (‘420) specifically
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`teaches that the shape and arrangement of the sensors may vary. See Exhibit 7, Nankai
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`at col. 8, lines 47-52. So in any case, the claimed arrangement would be one of a finite
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`number of identified, predictable solutions having a reasonable expectation of success
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`(and thus obvious to try).
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`26. Nankai (‘420) also discloses applying the sample liquid to the measuring
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`device. See Exhibit 7, Nankai (‘420) at col. 8, lines 25-30. And Nankai further
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`_______________________________________________________________________________
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`DECLARATION OF DR. JOSEPH WANG
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`20128452v1
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`Pharmatech Solutions, Inc: 1024-9
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`teaches that multiple measurements should be taken and averaged together. Id. at col.
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`8, lines 11-14 and 30-46.
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`27.
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`Schulman (‘344) teaches that multiple measurements should be taken to
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`identify errors. See Exhibit 10, Schulman (‘344) at col. 3, lines 17-28. Incorporating
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`this into Nankai (‘420) would be nothing more than the use of a known technique to
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`improve similar devices/methods in the same way, and the results would be
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`predictable. Schulman (‘344) further discloses comparing the measurements to
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`establish a difference parameter, and then giving an indication of an error if the
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`difference parameter is greater than a predetermined threshold. See Exhibit 10,
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`Schulman (‘344) at col. 3, lines 17-28. This would also be nothing more than the use
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`of a known technique to improve similar devices/methods in the same way, and the
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`results would be predictable.
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`28. A claim chart showing application of Nankai (‘420) and Schulman (‘344)
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`to claim 1 is attached hereto as Exhibit 17, and is incorporated fully as if set forth
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`herein.
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`Obviousness Ground 3
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`29.
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`It is my opinion that claim 1 is invalid under 35 U.S.C. § 103 as obvious
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`over Nankai (‘420) in view of Ramakant Khazanie, Statistics in a World of
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`Applications (1997) (“Khazanie”), Exhibit 11.
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`_______________________________________________________________________________
`9
`DECLARATION OF DR. JOSEPH WANG
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`20128452v1
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`Pharmatech Solutions, Inc: 1024-10
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`30. Nankai (‘420) discloses a test strip (or “measuring device”) that includes
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`all of the features of the measuring device of claim 1, except it does not explicitly
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`place the reference sensor upstream of the working sensor parts. However, such
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`configuration is merely an unpatentable rearrangement of parts. According to the ‘105
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`Patent, the sensor parts may be arranged in various configurations “as convenient”,
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`and no benefit or unexpected result is set forth for placing the reference sensor
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`upstream of both working sensor parts. See ‘105 Patent at col. 3, lines 36-58. Further,
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`Nankai (‘420) specifically teaches that the shape and arrangement of the sensors may
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`vary. See Exhibit 7, Nankai (‘420) at col. 8, lines 47-52. So in any case, the claimed
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`arrangement would be one of a finite number of identified, predictable solutions
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`having a reasonable expectation of success (and thus obvious to try).
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`31. Nankai (‘420) also discloses applying the sample liquid to the measuring
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`device. See Exhibit 7, Nankai (‘420) at col. 8, lines 25-30. And Nankai further
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`teaches that multiple measurements should be taken and averaged together. Id. at col.
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`8, lines 11-14 and 30-46.
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`32. Khazanie teaches that simply averaging the values of collected data
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`without doing more is an undesirable practice. For example, Khazanie says that
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`“Variability of values in data collected is a very common phenomenon, and its
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`importance should be acknowledged.” Exhibit 11, Khazanie at p. 101. To obtain a
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`better understanding of the collected data, either the mean deviation—or even more
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`preferably the standard deviation—should be computed. Id. at pp. 103-105. Thus,
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`Pharmatech Solutions, Inc: 1024-11
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`when considered in view of Nankai (‘420), Khazanie teaches that the electric current
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`from each of the working sensor parts should be compared to establish a difference
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`parameter (i.e., a mean deviation or a standard deviation). This would be nothing
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`more than the combination of prior art elements according to known methods to yield
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`predictable results, and Khazanie’s teaching further would have led one of ordinary
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`skill to modify Nankai (‘420) to include this step.
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`33. Because Nankai (‘420) teaches that it is important to obtain accurate
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`glucose readings, see Exhibit 7, Nankai (‘420) at col. 1, lines 18-19, col. 2, line 64, col.
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`4, lines 1-2, and col. 8, line 43, it would have been obvious to indicate that an error has
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`occurred if the difference parameter is greater than a predetermined threshold (i.e., if
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`the readings are not sufficiently accurate, meaning that the error is impermissible).
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`One of ordinary skill in the art would have been motivated to provide the indication of
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`an error based on the teachings of Nankai (‘420) and common sense.
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`34. A claim chart showing application of Nankai (‘420) and Khazanie to
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`claim 1 is attached hereto as Exhibit 18, and is incorporated fully as if set forth herein.
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`Obviousness Ground 4
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`35.
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`It is my opinion that claim 1 is invalid under 35 U.S.C. § 103 as obvious
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`over Nankai (‘420) in view of William Lichten, Data and Error Analysis in the
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`Introductory Physics Laboratory (1996) (“Lichten”), Exhibit 12.
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`_______________________________________________________________________________
`11
`DECLARATION OF DR. JOSEPH WANG
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`20128452v1
`
`Pharmatech Solutions, Inc: 1024-12
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
`
`
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`36. Nankai (‘420) discloses a test strip (or “measuring device”) that includes
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`all of the features of the measuring device of claim 1, except it does not explicitly
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`place the reference sensor upstream of the working sensor parts, as set forth in the
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`claim chart below. However, such configuration is merely an unpatentable
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`rearrangement of parts. According to the ‘105 Patent, the sensor parts may be
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`arranged in various configurations “as convenient”, and no benefit or unexpected
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`result is set forth for placing the reference sensor upstream of both working sensor
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`parts. See ‘105 Patent at col. 3, lines 36-58. Further, Nankai (‘420) specifically
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`teaches that the shape and arrangement of the sensors may vary. See Exhibit 7, Nankai
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`at col. 8, lines 47-52. So in any case, the claimed arrangement would be one of a finite
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`number of identified, predictable solutions having a reasonable expectation of success
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`(and thus obvious to try).
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`37. Nankai (‘420) also discloses applying the sample liquid to the measuring
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`device. See Exhibit 7, Nankai (‘420) at col. 8, lines 25-30. And Nankai further
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`teaches that multiple measurements should be taken and averaged together. Id. at col.
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`8, lines 11-14 and 30-46.
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`38.
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`Lichten teaches that simply averaging the values of collected data without
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`doing more is incomplete. Instead, an estimate of error in the measurement should be
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`obtained. See Exhibit 12, Lichten at p. 3. According to Lichten, a “handy measure” of
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`the error is the average deviation from the mean. Id. Thus, when considered in view
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`of Nankai (‘420), Lichten teaches that the electric current from each of the working
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`_______________________________________________________________________________
`12
`DECLARATION OF DR. JOSEPH WANG
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`20128452v1
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`Pharmatech Solutions, Inc: 1024-13
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`sensor parts should be compared to establish a difference parameter (i.e., the average
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`deviation). This would be nothing more than the combination of prior art elements
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`according to known methods to yield predictable results, and Lichten’s teaching
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`further would have led one of ordinary skill to modify Nankai (‘420) to include this
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`step.
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`39. Because Nankai (‘420) teaches that it is important to obtain accurate
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`glucose readings, see Exhibit 7, Nankai (‘420) at col. 1, lines 18-19, col. 2, line 64, col.
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`4, lines 1-2, and col. 8, line 43, it would have been obvious to indicate that an error has
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`occurred if the difference parameter is greater than a predetermined threshold (i.e., if
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`the readings are not sufficiently accurate, meaning that the error is impermissible).
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`One of ordinary skill in the art would have been motivated to provide the indication of
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`an error based on the teachings of Nankai (‘420) and common sense.
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`A claim chart showing application of Nankai (‘420) and Lichten to claim 1 is
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`attached hereto as Exhibit 19, and is incorporated fully as if set forth herein.
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`Obviousness Ground 5
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`40.
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`It is my opinion that claim 1 is invalid under 35 U.S.C. § 103 as set forth
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`in Obviousness Grounds 1-4 above, further in view of Winarta (‘229). Winarta (‘229)
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`discloses placing the reference sensor part R upstream from the working sensor parts
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`W, Wo and unidirectional flow as claimed. See Exhibit 8, Winarta (‘229) at col. 5,
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`line 59 to col. 6, line 10; col. 7, lines 23-25; FIG. 2. Incorporating this into Nankai
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`_______________________________________________________________________________
`13
`DECLARATION OF DR. JOSEPH WANG
`
`20128452v1
`
`Pharmatech Solutions, Inc: 1024-14
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`(‘420) would be nothing more than the use of a known technique to improve similar
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`devices/methods in the same way, and the results would be predictable.
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`41. A partial claim chart showing this application of Winarta (‘229) to claim
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`1 is attached hereto as Exhibit 20, and is incorporated fully as if set forth herein. This
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`claim chart supplements the charts associated with Obviousness Grounds 1-4 above.
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`Obviousness Ground 6
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`42.
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`It is my opinion that claim 1 is invalid under 35 U.S.C. § 103 as set forth
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`in Obviousness Grounds 1-5 above, further in view of U.S. Pat. No. 5,672,256 to Yee
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`(“Yee (‘256)”), a copy of which is attached hereto as Exhibit 13. Yee (‘256) discloses
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`that the arrangement of electrodes does not affect their characteristics. See Exhibit 13,
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`Yee (‘256) at col. 2, lines 11-13. This further confirms that it would be obvious to
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`place the reference sensor upstream of the working sensor parts, as set forth in claim 1.
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`43. A partial claim chart showing this application of Yee (‘256) to claim 1 is
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`attached hereto as Exhibit 21, and is incorporated fully as if set forth herein. This
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`claim chart supplements the charts associated with Obviousness Grounds 1-5 above.
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`Obviousness Ground 7
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`44.
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`It is my opinion that claim 1 is invalid under 35 U.S.C. § 103 as set forth
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`in Obviousness Grounds 1-6 above, further in view of U.S. Pat. No. 6,540,891 to
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`Stewart (“Stewart (‘891)”), a copy of which is attached hereto as Exhibit 14. Stewart
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`_______________________________________________________________________________
`14
`DECLARATION OF DR. JOSEPH WANG
`
`20128452v1
`
`Pharmatech Solutions, Inc: 1024-15
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`(‘891) discloses that the glucose meters typically used with disposable test strips have
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`electronic features designed to detect invalid test results and report an error condition.
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`See Exhibit 14, Stewart (‘891) at col. 11, lines 18-23. Incorporating this feature from
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`Stewart (‘891) would be nothing more than the use of a known technique to improve
`
`similar devices/methods in the same way, and the results would be predictable.
`
`45. A partial claim chart showing application of Stewart (‘891) to claim 1 is
`
`attached hereto as Exhibit 22, and is incorporated fully as if set forth herein. This
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`claim chart supplements the charts associated with Obviousness Grounds 1-6 above.
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`Obviousness Ground 8
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`46.
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`It is my opinion that claim 1 is invalid under 35 U.S.C. § 103 as set forth
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`in Obviousness Grounds 1-6 above, further in view of U.S. Pat. No. 5,004,998 to Horii
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`(“Horii (‘998”), a copy of which is attached hereto as Exhibit 15. Horii (‘998) teaches
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`giving an indication of an error if a difference parameter is greater than a
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`predetermined threshold. See Exhibit 15, Horii (‘998) at Abstract; col. 4, lines 8-16;
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`col. 5, lines 5-9; FIG. 2. Incorporating this feature from Horii (‘998) would be nothing
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`more than the use of a known technique to improve similar devices/methods in the
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`same way, and the results would be predictable.
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`47. A partial claim chart showing application of Horii (‘998) to claim 1 is
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`attached hereto as Exhibit 23, and is incorporated fully as if set forth herein. This
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`claim chart supplements the charts associated with Obviousness Grounds 1-6 above.
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`_______________________________________________________________________________
`15
`DECLARATION OF DR. JOSEPH WANG
`
`20128452v1
`
`Pharmatech Solutions, Inc: 1024-16
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
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`Obviousness Ground 9
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`48.
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`It is my opinion that claim 1 is invalid under 35 U.S.C. § 103 as obvious
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`over Winarta (‘229) in view of Say (‘752).
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`49. Winarta (‘229) discloses a test strip (or “measuring device”) that includes
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`all of the features of the measuring device of claim 1, as set forth in the claim chart
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`referenced below and in the rejection of the ‘714 Application discussed above. The
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`first and second working sensor parts W, Wo in Winarta (‘229) are constructed in the
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`same manner and include the same reagent, and it appears to me that they are the same
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`size. See Exhibit 8, Winarta (‘229) at col. 5, lines 37-54; col. 7, lines 11-42; col. 9,
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`lines 4-14; FIG. 2. Even if W and Wo are not the same size, however, one of ordinary
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`skill in the art would have altered the sizing to arrive at a uniform size to take
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`advantage of the Say (‘752) disclosure of taking multiple measurements and
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`performing averaging and comparison functions.
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`50. Winarta (‘229) also discloses applying the sample liquid to the measuring
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`device. See Exhibit 8, Winarta (‘229) at col. 5, lines 59-62; col. 10, lines 1-67.
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`51.
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`Say (‘752) discloses that readings should be taken from multiple
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`electrodes and compared to one another to identify errors. See Exhibit 9, Say (‘752) at
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`col. 39, lines 26-46; col. 40, lines 11 and 14-16. Because the test strip of Winarta
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`(‘229) is capable of taking multiple measurements (i.e., using the first working sensor
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`part W and the second working sensor part Wo), it would have been obvious to take
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`multiple measurements and obtain an average as taught by Say (‘752). This would be
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`_______________________________________________________________________________
`16
`DECLARATION OF DR. JOSEPH WANG
`
`20128452v1
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`Pharmatech Solutions, Inc: 1024-17
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105
`
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`nothing more than the use of a known technique to improve similar devices/methods in
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`the same way, and the results would be predictable.
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`52. When the comparison in Say (‘752) reveals that the difference in readings
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`is outside a predetermined threshold level, the patient is alerted that the sensor is
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`defective. See Exhibit 9, Say (‘752) at col. 39, lines 26-46 and col. 40, line 11.
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`Alerting users of the Winarta (‘229) device of defects would have been obvious in
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`light of the teachings of Say (‘752). This would nothing more than the use of a known
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`technique to improve similar devices/methods in the same way, and the results would
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`be predictable.
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`53. A claim chart showing application of Winarta (‘229) and Say (‘752) to
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`claim 1 is attached hereto as Exhibit 24, and is incorporated fully as if set forth herein.
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`Obviousness Ground 10
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`54.
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`It is my opinion that claim 1 is invalid under 35 U.S.C. § 103 as obvious
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`over W
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