UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
`
`AGAMATRIX, INC.
`Petitioner
`
`v.
`
`
`DEXCOM, INC.
`Patent Owner
`
`________________________
`
`
`U.S. PATENT NO. 9,724,045
`
`SYSTEMS AND METHODS FOR REPLACING SIGNAL ARTIFACTS
`IN A GLUCOSE SENSOR DATA STREAM
`
`Case Nos. IPR2018-01715 & IPR2018-01716
`________________________
`
`DECLARATION OF JOHN L. SMITH, PH.D.
`
`TITLE:
`
`
`
`
`
`Main Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
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`AGAMATRIX, INC. EXHIBIT NO. 1003
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`Declaration of John L. Smith, Ph.D.
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`TABLE OF CONTENTS
`
`Page
`INTRODUCTION ........................................................................................... 1
`I.
`BACKGROUND AND QUALIFICATIONS ................................................. 2
`II.
`SUMMARY OF OPINION ............................................................................. 5
`III.
`IV. LEGAL STANDARDS ................................................................................... 5
`A.
`Priority Date .......................................................................................... 6
`B.
`Claim Construction ............................................................................... 6
`C.
`Anticipation ........................................................................................... 7
`D. Obviousness ........................................................................................... 8
`LEVEL OF ORDINARY SKILL IN THE ART ........................................... 13
`V.
`VI. KNOWLEDGE IN THE ART AT THE TIME OF THE ʼ045
`PATENT’S ALLEGED INVENTION .......................................................... 14
`A.
`Electrochemical Glucose Measurement .............................................. 14
`B.
`Cottrell Equation ................................................................................. 21
`C.
`Error-Detection & Error-Rejection in Signal Processing ................... 22
`VII. THE ʼ045 PATENT ....................................................................................... 24
`A. Overview of the ʼ045 Patent ................................................................ 24
`B.
`Independent Claims of the ʼ045 Patent ............................................... 32
`VIII. CLAIM CONSTRUCTION .......................................................................... 37
`IX. OVERVIEW OF THE PRIOR ART ............................................................. 38
`1.
`Berner ........................................................................................ 39
`2. White ......................................................................................... 43
`3.
`Beaty ......................................................................................... 46
`4.
`Schulman ................................................................................... 49
`X. ANALYSIS OF CHALLENGED CLAIMS OF THE ’045
`Patent IN LIGHT OF THE PRIOR ART ...................................................... 51
`
`
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`Declaration of John L. Smith, Ph.D.
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`iii.
`
`iv.
`
`A. Obviousness of Claims 16-21 and 23-25 in view of
`Berner. ................................................................................................. 51
`1.
`Independent Claim 16 ............................................................... 52
`i.
`Preamble. ........................................................................ 52
`ii.
`“an electrochemical glucose sensor
`configured to be in contact with a biological
`sample for measuring a glucose
`concentration, wherein the electrochemical
`glucose sensor comprises a first electrode, a
`second electrode, and an enzyme-containing
`film” (Element [16.a]). ................................................... 52
`“sensor electronics comprising a processor
`for executing a computer program code
`stored in a memory to cause the sensor
`electronics to [perform the recited
`functions].” (Element [16.b]). ......................................... 61
`“apply a voltage to the electrochemical
`glucose sensor at a first setting” (Element
`[16.c]). ............................................................................. 63
`“switch the voltage applied to the
`electrochemical sensor to a different setting”
`(Element [16.d]). ............................................................. 65
`“measure a signal response of the
`electrochemical glucose sensor responsive to
`the switching” (Element [16.e])...................................... 68
`“evaluate a severity associated with a signal
`artifact based on the measured signal
`response of the electrochemical glucose
`sensor to the switching, wherein the signal
`artifact is associated with a non-glucose rate
`limiting phenomenon” (Element [16.f]). ........................ 72
`viii. “generate an estimated glucose
`concentration value when the severity
`associated with the signal artifact is
`evaluated to be under a predetermined
`
`v.
`
`vi.
`
`vii.
`
`
`
`
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`Declaration of John L. Smith, Ph.D.
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`ix.
`
`threshold, wherein the estimated glucose
`concentration value accounts for the severity
`associated with the signal artifact” (Element
`[16.g]). ............................................................................ 77
`“a user interface configured to display the
`estimated glucose concentration value”
`(Element [16.h]). ............................................................. 83
`Dependent Claim 17 ................................................................. 85
`2.
`Dependent Claim 18 ................................................................. 88
`3.
`Dependent Claim 19 ................................................................. 89
`4.
`Dependent Claim 20 ................................................................. 90
`5.
`Dependent Claim 21 ................................................................. 91
`6.
`Dependent Claim 23 ................................................................. 91
`7.
`Dependent Claim 24 ................................................................. 93
`8.
`Dependent Claim 25 ................................................................. 96
`9.
`Obviousness of Claims 37-39 and 41-43 in view of
`Berner and Schulman .......................................................................... 97
`1.
`Independent Claim 37 ............................................................... 97
`i.
`“Wherein the measured signal response is a
`time-varying voltage response of the
`electrochemical glucose sensor” ..................................... 98
`The “User Interface” Limitations ................................... 99
`ii.
`iii. Motivation To Combine Schulman with
`Berner. .......................................................................... 104
`Dependent Claims 38-39 and 41-43 ....................................... 108
`2.
`Obviousness of Claims 16-20 and 23-25 in view of White
`and Beaty ........................................................................................... 108
`1.
`The Combination of White and Beaty Teaches All
`The Elements of Independent Claim 16 ................................. 109
`i.
`Preamble. ...................................................................... 109
`
`B.
`
`C.
`
`
`
`
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`Declaration of John L. Smith, Ph.D.
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`ii.
`
`iii.
`
`iv.
`
`“an electrochemical glucose sensor
`configured to be in contact with a biological
`sample for measuring a glucose
`concentration, wherein the electrochemical
`glucose sensor comprises a first electrode, a
`second electrode, and an enzyme-containing
`film” (Element [16.a]). ................................................. 109
`“sensor electronics comprising a processor
`for executing a computer program code
`stored in a memory to cause the sensor
`electronics to [perform the recited
`functions].” (Element [16.b]). ....................................... 113
`“apply a voltage to the electrochemical
`glucose sensor at a first setting” (Element
`[16.c]). ........................................................................... 115
`“switch the voltage applied to the
`electrochemical sensor to a different setting”
`(Element [16.d]). ........................................................... 119
`“measure a signal response of the
`electrochemical glucose sensor responsive to
`the switching” (Element [16.e]).................................... 120
`“evaluate a severity associated with a signal
`artifact based on the measured signal
`response of the electrochemical glucose
`sensor to the switching, wherein the signal
`artifact is associated with a non-glucose rate
`limiting phenomenon” (Element [16.f]). ...................... 123
`viii. “generate an estimated glucose
`concentration value when the severity
`associated with the signal artifact is
`evaluated to be under a predetermined
`threshold, wherein the estimated glucose
`concentration value accounts for the severity
`associated with the signal artifact” (Element
`[16.g]). .......................................................................... 126
`
`v.
`
`vi.
`
`vii.
`
`
`
`
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`Declaration of John L. Smith, Ph.D.
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`ix.
`
`“a user interface configured to display the
`estimated glucose concentration value”
`(Element [16.h]). ........................................................... 129
`2. Motivation To Combine White and Beaty. ............................. 130
`3.
`Dependent Claim 17 ............................................................... 133
`4.
`Dependent Claim 18 ............................................................... 134
`5.
`Dependent Claim 19 ............................................................... 135
`6.
`Dependent Claim 20 ............................................................... 136
`7.
`Dependent Claim 23 ............................................................... 137
`8.
`Dependent Claim 24 ............................................................... 138
`9.
`Dependent Claim 25 ............................................................... 140
`D. Obviousness of Claims 37-38 and 41-43 in view of
`White, Beaty, and Schulman ............................................................. 141
`1.
`Independent Claim 37 ............................................................. 141
`i.
`“Wherein the measured signal response is a
`time-varying voltage response of the
`electrochemical glucose sensor” ................................... 142
`The “User Interface” Limitations ................................. 143
`ii.
`iii. Motivation To Combine Schulman with
`White-Beaty. ................................................................. 149
`Dependent Claims 38 and 41-43 ............................................. 154
`2.
`XI. CONCLUDING STATEMENTS ................................................................ 154
`
`
`
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`I.
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`Declaration of John L. Smith, Ph.D.
`
`DECLARATION OF JOHN L. SMITH, PH.D.
`
`I, John L. Smith, declare as follows:
`
`INTRODUCTION
`1.
`
`I have been retained by AgaMatrix, Inc. (“AgaMatrix” or
`
`“Petitioner”), through its counsel, as a technical expert witness in connection with
`
`the above-captioned petitions for inter partes review. The petitions for inter partes
`
`review involve U.S. Patent No. 9,724,045 (“the ʼ045 patent”) (Ex. 1001).
`
`2.
`
`I have been asked by Petitioner to offer opinions regarding the ʼ045
`
`patent, including the patentability of certain claims in view of prior art. This
`
`declaration sets forth the opinions I have reached to date regarding these matters.
`
`3.
`
`In preparing this declaration, I have reviewed the ʼ045 patent, its
`
`prosecution history, and each of the documents I reference here. In reaching my
`
`opinions, I have relied upon my experience in the field of electrochemistry and
`
`have also considered the viewpoint of a person of ordinary skill in the art at the
`
`time of the ʼ045 patent’s priority date. As explained below, I am familiar with the
`
`level of skill of a person of ordinary skill in the art regarding the technology at
`
`issue as of that time frame.
`
`4.
`
`I am being compensated at my normal rate of $400 per hour in
`
`connection with this matter. My compensation is not contingent on the outcome of
`
`this matter or on the substance of my opinions.
`
`1
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`II. BACKGROUND AND QUALIFICATIONS
`5. My qualifications for forming the opinions set forth in this
`
`Declaration of John L. Smith, Ph.D.
`
`Declaration are summarized here and explained in more detail in my curriculum
`
`vitae, which is attached as Exhibit 1004.
`
`6.
`
`I am a consultant in the areas of analytical chemistry, clinical
`
`chemistry, blood glucose monitoring, and non-invasive blood measurements. I
`
`hold a Bachelor of Science degree in chemistry from Butler University and a Ph.D.
`
`in analytical chemistry from the University of Illinois.
`
`7.
`
`I have over 55 years of experience in electrochemical analytical
`
`instruments and systems; 30 of those years have been spent in the blood glucose
`
`monitoring field. My work includes development of novel electrochemical
`
`instrumentation, development of automated clinical laboratory instrumentation,
`
`research and development of blood glucose meters and test strips, development of
`
`intravascular glucose measurement systems, and development of noninvasive
`
`glucose measurement systems.
`
`8.
`
`At the LifeScan division of Johnson & Johnson, I was employed for
`
`twelve years in the positions of Vice President of Research, Development, and
`
`Engineering (R, D & E), Worldwide Vice President of R, D & E, and Chief
`
`Scientific Officer. Prior to that time, I had been employed as a Senior Applications
`
`Chemist and Manager of Product Development for electrochemical
`
`2
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`instrumentation at Princeton Applied Research, and as a Staff Systems Engineer
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`Declaration of John L. Smith, Ph.D.
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`and Director of Decentralized Testing at Technicon Instruments Corporation.
`
`9.
`
`Since my retirement from Johnson & Johnson, I have consulted for
`
`more than 40 blood glucose companies or their investors, including LifeScan, Inc.,
`
`TheraSense, Insulet, Masimo Corporation and Cercacor Laboratories.
`
`10.
`
`I hold seventeen issued United States patents (most with foreign
`
`counterparts) and many additional published United States patent applications.
`
`Eleven of the aforementioned issued patents relate to glucose monitoring, four
`
`relate to clinical laboratory instrumentation, and two relate to novel
`
`electrochemical instrumentation. I have authored publications in refereed journals
`
`and a manuscript entitled “The Pursuit of Noninvasive Glucose: Hunting the
`
`Deceitful Turkey,” 6th Edition: Revised and Expanded,” 2018.
`
`11.
`
`In the past four years, I have served as an expert witness for patent
`
`infringement litigation (or arbitrations) or PTAB proceedings in the following
`
`cases:
`
`• Becton Dickenson and Company v. Insulet, United States District Court,
`District of New Jersey, Case# 10-04371-PGS –ES.
`• Medtronic, et al. v. Insulet, United States District Court for Central
`California, Case No. 2:12-CV-8048-PA-CWx.
`• Masimo Corp. v. Philips Electronics North American Corporation and
`Philips Medizin Systeme Böblingen GmbH, United States District Court for
`the District of Delaware, Case No. 1:09-cv-00080-JJF-MPT.
`
`3
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`Declaration of John L. Smith, Ph.D.
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`• Masimo Corporation and Cercacor Laboratories, Inc. arbitration against
`Nova Biomedical Corporation, JAMS Reference # 1220045324.
`• Pharmatech Solutions, Inc. v. Lifescan Scotland Ltd., IPR2013-00247Inter
`Partes Review of U.S. Patent No. 7,250,105.
`• Dominion Assets, LLC, v. Masimo Corporation and Cercacor Laboratories,
`United States District Court for the Northern District of California, Case CV
`12-2773.
`• LifeScan Scotland, Ltd v. Pharmatech Solutions, Inc., United States District
`Court for the Northern District of California, Case CV 11-04494 MEJ.
`• Dominion Assets, LLC v. Masimo Corporation and Cercacor Laboratories,
`United States District Court for the Northern District of California, Case 14-
`cv-03002-BLF.
`• LifeScan, Inc. v. Unistrip Technologies, LLC., United States District Court
`for the Western District Of North Carolina, Charlotte Division, Case 3:14-
`CV-00274.
`• WaveForm, Inc. v. Dexcom, Inc., United States District Court for the District
`of Oregon, Case No. 3:16-cv-00536-MO.
`• Dexcom, Inc. U.S. Patent and Trial Appeal Board Inter Partes Review 2016-
`01679 of U.S. Patent No. 7,146,202.
`• Dexcom, Inc. U.S. Patent and Trial Appeal Board Inter Partes Review 2016-
`01680 of U.S. Patent No. 8,187,433.
`• Pharma Tech Solutions, Inc. and Decision IT Corp. v. LifeScan, Inc,
`LifeScan Scotland, Ltd, and Johnson and Johnson, Case No. 2:16-cv-00564-
`RFB-PAL, United States District Court for the District of Nevada.
`• Dexcom, Inc. U.S. Patent and Trial Appeal Board Inter Partes Review 2017-
`01051 of U.S. Patent No. 7,529,574.
`
`4
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`Declaration of John L. Smith, Ph.D.
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`• Dexcom, Inc. v. AgaMatrix, Inc., United States District Court for the Central
`District of California, Case No. 2:16-cv-5497 (SJO) (ASx).
`• Certain Electrochemical Glucose Monitoring Systems And Components
`Thereof, United States International Trade Commission, Investigation No.
`337-TA-1075.
`
`III. SUMMARY OF OPINION
`12. As set forth in more detail herein, all the elements of the claims
`
`challenged in the corresponding petitions for inter partes review were either well
`
`known or would have been obvious to a person of ordinary skill in the art before
`
`the ʼ045 patent’s priority date.
`
`13.
`
`In particular, various combinations of the Berner, White, Beaty, and
`
`Schulman references render obvious each of claims 16-21, 23-25, 37-39, 41-43
`
`(“challenged claims”). As such, in my opinion, these claims should be found
`
`unpatentable.
`
`14.
`
`I reserve the right to supplement my opinions in the future to respond
`
`to any arguments or positions Patent Owner may raise, taking account of new
`
`information as it becomes available to me.
`
`IV. LEGAL STANDARDS
`15.
`I am not a lawyer. Therefore, in formulating my opinions and
`
`conclusions in this proceeding, I have been provided with an understanding of the
`
`prevailing principles of U.S. patent law that govern the issues of patent validity.
`
`5
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`A.
`16.
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`Declaration of John L. Smith, Ph.D.
`
`Priority Date
`
`I understand that the prior art to the ʼ045 patent includes patents and
`
`printed publications in the relevant art that predate the ʼ045 patent’s priority date.
`
`17.
`
`I have been asked to use August 22, 2003, the filing date of the
`
`earliest U.S. application to which the ʼ045 patent claims priority, as the earliest
`
`possible priority date for the purpose of my analysis and this declaration. I am not
`
`offering any opinion as to whether the ’045 patent is actually entitled to the August
`
`22, 2003 priority date.
`
`B. Claim Construction
`18.
`I am informed and understand that it is a basic principle of patent law
`
`that assessing the validity of a patent claim involves a two-step analysis. In the
`
`first step, the claim language must be properly construed to determine its scope and
`
`meaning. In the second step, the claim as properly construed must be compared to
`
`the alleged prior art to determine whether the claim is valid.
`
`19.
`
`I am informed and understand that the standard used by the Patent
`
`Office to construe patent claims during an IPR proceeding differs from the
`
`standard used in district court litigation proceedings.
`
`20.
`
`I am informed and understand the law and PTAB rules require that a
`
`patent claim in an unexpired patent must be given its broadest reasonable
`
`interpretation (“BRI”) in light of the specification of the patent in which it appears.
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`6
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`I also understand that, under the BRI standard, a claim term should be given its
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`Declaration of John L. Smith, Ph.D.
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`plain meaning consistent with how those skilled in the art would interpret it, unless
`
`such meaning is inconsistent with the specification and prosecution history.
`
`C. Anticipation
`21.
`I am informed and understand that to anticipate a patent claim under
`
`35 U.S.C. § 102, a single asserted prior art reference must disclose each and every
`
`element of the claimed invention, either explicitly or inherently, to a person of
`
`ordinary skill in the art. There must be no difference between the claimed
`
`invention and the disclosure of the alleged prior art reference as viewed from the
`
`perspective of the person of ordinary skill in the art. Also, I understand that in
`
`order for a reference to be an anticipating reference, it must describe the claimed
`
`subject matter with sufficient clarity to establish that the subject matter existed and
`
`that its existence was recognized by persons of ordinary skill in the field of the
`
`invention. In addition, I am informed and understand that in order to establish that
`
`an element of a claim is “inherent” in the disclosure of an asserted prior art
`
`reference, the extrinsic evidence (or the evidence outside the four corners of the
`
`asserted prior art reference) must make clear that the missing element is the
`
`inevitable outcome of the process and/or thing that is explicitly described in the
`
`asserted prior art reference, and that it would be recognized as necessarily present
`
`by persons of ordinary skill in the relevant field.
`
`7
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`Declaration of John L. Smith, Ph.D.
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`D. Obviousness
`22.
`I am also informed and understand that even though a prior art
`
`reference does not fully anticipate a claim of a patent, a claim may, nonetheless, be
`
`rendered obvious to a person of ordinary skill in the art if the differences between
`
`the subject matter set forth in the patent claim and the prior art are such that the
`
`subject matter as a whole of the claim would have been obvious at the time the
`
`claimed invention was made.
`
`23.
`
`I am informed and understand that obviousness is a determination of
`
`law based on various underlying determinations of fact. In particular, these
`
`underlying factual determinations include (1) the scope and content of the prior art;
`
`(2) the level of ordinary skill in the art at the time the claimed invention was made;
`
`(3) the differences between the claimed invention and the prior art; and (4) the
`
`extent of any proffered objective indicia of nonobviousness. I understand that the
`
`objective indicia which may be considered in such an analysis include commercial
`
`success of the patented invention (including evidence of industry recognition or
`
`awards), whether the invention fills a long-felt but unsolved need in the field, the
`
`failure of others to arrive at the invention, industry acquiescence and recognition,
`
`initial skepticism of others in the field, whether the inventors proceeded in a
`
`direction contrary to the accepted wisdom of those of ordinary skill in the art, and
`
`the taking of licenses under the patent by others, among other factors.
`
`8
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`Declaration of John L. Smith, Ph.D.
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`24. To ascertain the scope and content of the prior art, it is necessary to
`
`first examine the field of the inventor’s endeavor and the particular problem for
`
`which the invention was made. The relevant prior art includes prior art in the field
`
`of the invention, and also prior art from other fields that a person of ordinary skill
`
`in the art would look to when attempting to solve the problem.
`
`25.
`
`I am informed and understand that a determination of obviousness
`
`cannot be based on the hindsight combination of components selectively culled
`
`from the prior art to fit the parameters of the patented invention. Instead, it is my
`
`understanding that in order to render a patent claim invalid as being obvious from a
`
`combination of references, there must be some evidence within the prior art as a
`
`whole to suggest the desirability, and thus the obviousness, of making the
`
`combination in a way that would produce the patented invention.
`
`26.
`
`I am further informed and understand that in an obviousness analysis,
`
`neither the motivation nor the purpose of the patentee dictates. What is important is
`
`whether there existed at the time of the invention a known problem for which there
`
`was an obvious solution encompassed by the patent’s claims.
`
`27.
`
`In addition, it is my understanding that in order to find a patent claim
`
`invalid for obviousness, there must be a finding that each element in each
`
`limitation of the patent claim is disclosed, taught, or suggested by the asserted
`
`combination of prior art references or elsewhere in the relevant prior art. I
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`9
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`understand, however, that a patent claim composed of several elements is not
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`Declaration of John L. Smith, Ph.D.
`
`proved obvious merely by demonstrating that each of its elements was,
`
`independently, known in the prior art. But multiple prior art references or elements
`
`may, in some circumstances, be combined to render a patent claim obvious. I
`
`understand that I should consider whether there is an “apparent reason” or
`
`motivation to combine the prior art references or elements in the way the patent
`
`claims. To determine whether such an “apparent reason” or motivation exists to
`
`combine the prior art references or elements in the way a patent claims, it will
`
`often be necessary to look to the interrelated teaching of multiple prior art
`
`references, to the effects of demands known to the design community or present in
`
`the marketplace, and to the background knowledge possessed by a person of
`
`ordinary skill in the art.
`
`28.
`
`I also understand that when the prior art “teaches away” from
`
`combining prior art references or certain known elements, discovery of a
`
`successful means of combining them is more likely to be nonobvious. A prior art
`
`reference may be said to “teach away” from a patent when a person of ordinary
`
`skill in the art, upon reading the reference, would be discouraged from following
`
`the path set out in the patent or would be led in a direction divergent from the path
`
`that was taken by the patent. Additionally, a prior art reference may “teach away”
`
`from a claimed invention when substituting an element within that prior art
`
`10
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`reference for a claim element would render the claimed invention inoperable.
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`Declaration of John L. Smith, Ph.D.
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`29.
`
`I am informed and understand that a patent for a combination which
`
`only recites old elements with no change in their respective functions withdraws
`
`what is already known into the field of its monopoly and diminishes the resources
`
`available to person of ordinary skill in the field. When a patent claims a structure
`
`already known in the prior art that is altered by mere substitution of one element
`
`for another known in the field, the combination must do more than yield a
`
`predictable result. I am informed and understand that the corollary to this principle
`
`is that when the prior art teaches away from combining known elements, discovery
`
`of a successful means of combining them is more likely to be nonobvious. Thus,
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`the question to be answered is whether someone reading the prior art would be
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`discouraged from following the path taken by the inventor.
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`30.
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`I am further informed and understand that when an element is
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`available in one field of endeavor, design incentives and other market forces can
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`prompt variations of it, either in the same field or a different one. If a person of
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`ordinary skill in the art can implement a predictable variation of that available
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`element, Section 103 likely renders the invention obvious. For the same reason, I
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`am informed and understand that if a technique has been used to improve one
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`device or process, and a person of ordinary skill in the art would recognize that
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`such technique would improve similar devices or processes in the same way, using
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`the technique is obvious unless its actual application is beyond his or her skill.
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`Declaration of John L. Smith, Ph.D.
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`Following these principles often requires one to look to interrelated teachings of
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`multiple patents; the effects of demands known to the design community present in
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`the marketplace; and the background knowledge possessed by a person having
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`ordinary skill in the art, all in order to determine whether there was an apparent
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`reason to combine the known element in the manner claimed by the patent at issue.
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`I am further informed and understand that the analysis need not seek out precise
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`teachings directed to the specific subject matter of the challenged claim, because
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`one can take account of the inferences and creative steps that a person of ordinary
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`skill in the art would employ.
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`31.
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`I am further informed and understand that although the use of the
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`“teaching, suggestion or motivation” test for combining references has not been
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`completely rejected, the obviousness analysis cannot be confined by a formalistic
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`conception of the words teaching, suggestion, and motivation, or by overemphasis
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`on the importance of published articles and the explicit content of issued patents. I
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`am informed and understand that in many fields there is little discussion of obvious
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`techniques or combinations, and it is often the case that market demand, rather than
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`scientific literature, drive design trends. Under the correct analysis, any need or
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`problem known in the field of endeavor at the time of the invention and addressed
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`by the patent can provide a reason for combining the elements in the manner
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`claimed. Finally, I am informed and understand that common sense teaches that
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`Declaration of John L. Smith, Ph.D.
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`familiar items may have obvious uses beyond their primary purposes and, in many
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`cases, a person of ordinary skill in the art will be able to fit the teachings of
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`multiple patents together like pieces of a puzzle.
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`32. Therefore, I will analyze the prior art applied in Petitioner’s proposed
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`grounds using this framework.
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`V. LEVEL OF ORDINARY SKILL IN THE ART
`33.
`I am informed and understand that the claims of a patent are judged
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`from the perspective of a hypothetical construct involving a “person of ordinary
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`skill in the art.” The “art” is the field of technology to which the patent is related.
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`I understand that the purpose of using the viewpoint of a person of ordinary skill in
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`the art is for objectivity. I understand that a person of ordinary skill in the art is
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`presumed to know and be familiar with all of the relevant art in the field at the time
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`of invention and is also presumed to possess an average level of creativity.
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`34.
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`I was also asked to provide an opinion regarding the skill level of a
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`person of ordinary skill in the art of the ʼ045 patent. I considered several factors,
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`including the types of problems encountered in the art, the solutions to those
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`problems, the pace of innovation in the field, the sophistication of the technology,
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`and the education level of active workers in the field.
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`Declaration of John L. Smith, Ph.D.
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`35.
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`It is my opinion that a person of ordinary skill in the art (i.e., a skilled
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`artisan, or “POSITA”) at the time of the ʼ045 patent’s invention would have the
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`equivalent of either (i) a bachelor’s or master’s degree in biology, chemistry,
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`physics, electrical engineering, or related fields, and at least five years of
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`experience developing glucose sensors or other biosensensors; or (ii) a Ph.D. with
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`at least two years of experience in the same fields. Additional graduate education
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`could substitute for professional experience, and significant work experience could
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`substitute for formal education.
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`36.
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`I am qualified as a person of at least ordinary skill in