UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`ABBOTT DIABETES CARE INC.,
`Petitioner
`
`v.
`
`DEXCOM, INC.,
`Patent Owner.
`_________
`
`Case: IPR2022-00917
`
`Patent 10,980,452
`_________
`
`DECLARATION OF JOHN L. SMITH, PH.D. IN SUPPORT OF PETITION
`FOR INTER PARTES REVIEW OF U.S. PAT. NO. 10,980,452
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`TABLE OF CONTENTS
`
` 
`
` 
`
`V. 
`
`
`INTRODUCTION ........................................................................................... 1 
`I. 
`QUALIFICATIONS ........................................................................................ 2 
`II. 
`III.  UNDERSTANDING OF APPLICABLE LEGAL STANDARDS ................ 5 
`IV.  TECHNOLOGY BACKGROUND ................................................................. 7 
`Background of Continuous Glucose Monitor Sensors .......................... 8 
` 
`Electrochemistry Background ............................................................. 10 
`Calibration Background ...................................................................... 12 
` 
`THE 452 PATENT ........................................................................................ 13 
`Calibration Using Reference Measurements ....................................... 13 
` 
`Priority Claims and Prosecution History ............................................. 14 
` 
`VI.  LEVEL OF ORDINARY SKILL IN THE ART ........................................... 14 
`VII.  OTHER OPINIONS RELIED ON ................................................................ 16 
`VIII.  PRIOR ART RELIED ON IN PETITION .................................................... 16 
`References Relied on by Mr. Leinsing ................................................ 16 
` 
`Gross (EX1024) ................................................................................... 20 
`The Subject Prior Art Is Analogous .................................................... 28 
` 
`  A POSITA’s Knowledge of Using Predictive Relationships Between
`In Vitro and In Vivo Sensor Sensitivities to Calibrate Sensor Data as
`Disclosed by Gross .............................................................................. 29 
`IX.  CLAIM CONSTRUCTION .......................................................................... 30 
`X. 
`THE PREDICTIVE RELATIONSHIP ELEMENT OF DEPENDENT
`CLAIM 18 WOULD HAVE BEEN OBVIOUS TO A POSITA .................. 31 
`Petitioned Grounds and Claim 18 ....................................................... 31 
` 
`  Motivation to Combine with Gross ..................................................... 33 
`Gross Teaches the Predictive Relationship Element of Claim 18 ...... 36 
` 
`XI.  SECONDARY CONSIDERATIONS ........................................................... 41 
`XII.  CONCLUSION .............................................................................................. 41 
`
`
`i
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`I.
`
`INTRODUCTION
`
`I submit this declaration in support of a Petition for Inter Partes Review
`
`of U.S. Patent No. 10,980,452 (the “452 Patent”), owned by DexCom, Inc.
`
`(“DexCom”). I have been retained in this matter by counsel for Abbott Diabetes Care
`
`Inc. (“Petitioner”).
`
`
`
`Although I am being compensated for my time at my customary rate of
`
`$400 per hour in preparing this declaration, the opinions herein are my own, and I
`
`have no stake in the outcome of the review proceedings. My compensation does not
`
`depend in any way on the outcome of the Petition.
`
`
`
`The materials I considered in forming my opinions herein have
`
`included at least the 452 Patent (Exhibit 1001) and its prosecution history (Exhibit
`
`1002), as well as certain other exhibits submitted with IPR2022-00917, including
`
`the following:
`
` Exhibit 1001: U.S. Patent No. 10,980,542 (“452 Patent”)
`
` Exhibit 1003: Declaration of Karl R. Leinsing, MSME, PE in Support
`of Inter Partes Review of U.S. Patent No. 10,980,452
`
` Exhibit 1002: Prosecution File History of the 452 Patent
`
` Exhibit 1024: U.S. Patent No. 6,275,717 (“Gross”)
`
` Exhibit 1030: Spichiger-Keller, Ursula E., CHEMICAL SENSORS AND
`BIOSENSORS FOR MEDICAL AND BIOLOGICAL APPLICATIONS, Chapter 20,
`In vivo chemical sensors and biosensors in clinical medicine, by Denzil
`J. Claremont and John C. Pickup (pp. 356-376) (1998) (“Spichiger-
`Keller”)
`
`1
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`
`
`I also relied on my considerable experience with glucose monitoring
`
`systems and devices.
`
`II. QUALIFICATIONS
`
`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.
`
`
`
`I have over 55 years of experience with electrochemical analytical
`
`instruments and systems; 34 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, including for blood glucose meters and test strips,
`
`development of transcutaneous intravascular glucose measurement systems, and
`
`development of noninvasive glucose measurement systems.
`
`
`
`I have consulted for more than 50 companies in the field of blood
`
`glucose monitoring or their investors, including LifeScan, Inc., TheraSense, Insulet,
`
`Masimo Corporation, and Cercacor Laboratories.
`
`
`
`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
`
`2
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`Officer. Prior to that time, I had been employed as a Senior Applications Chemist
`
`and Manager of Product Development for electrochemical instrumentation at
`
`Princeton Applied Research, and as a Staff Systems Engineer and Director of
`
`Decentralized Testing at Technicon Instruments Corporation. Throughout my
`
`career, I have worked closely with numerous technicians, engineers, and scientists
`
`employed at all levels by technical organizations and who were persons of ordinary
`
`skill in the art, as I explain below.
`
`
`
`I hold seventeen issued United States patents (most with foreign
`
`counterparts) and five 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,” 8th
`
`Edition: Revised and Expanded, 2022.
`
` The full details of my education, employment, and consulting history
`
`are in my curriculum vitae, attached hereto as Appendix A (also filed as Exhibit
`
`1044).
`
` As detailed in Appendix A, I have participated as an expert witness in
`
`patent infringement litigation, including consulting, expert reports, depositions and
`
`court testimony in Markman hearings, arbitrations, bench trials, and jury trials in
`
`3
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`separate engagements. In the past four years, I have testified (either orally or by
`
`declaration) as an expert witness in the following cases:
`
` AgaMatrix, Inc. v. DexCom, Inc., Case No. 3:16:00536 (D. Or.);
` DexCom, Inc. v. AgaMatrix, Inc., Case 2:16-cv-05947-SJO-AS (C.D.
`Cal);
` DexCom, Inc. Inter Partes Review of U.S. Patent No. 7,146,202
`(P.T.A.B.);
` DexCom, Inc. Inter Partes Review of U.S. Patent No. 8,187,433
`(P.T.A.B.);
` 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 (D. Nev.);
` DexCom, Inc. Inter Partes Review of U.S. Patent No. 7,529,574
`(P.T.A.B.);
` Certain Electrochemical Glucose Monitoring Systems and
`Components thereof, Investigation No_337_TA_1075, U.S. I.T.C.;
` AgaMatrix Inter Partes Reviews IPR2018-01715 and IPR2018-01716
`of U.S. Patent No. 9,724,045 (P.T.A.B.);
` AgaMatrix Inter Partes Reviews IPR2018-01717 and IPR2018-01718
`of U.S. Patent No. 9,750,460 (P.T.A.B.);
` Arbmetrics, LLC v. DexCom, Inc., Case 3:18-cv-00134-JLS-MSB
`(S.D. Cal.)
` LifeScan, Inc. Inter Partes Review of U.S. Patent No. 8,480,878
`(P.T.A.B.); and
` LifeScan, Inc. Inter Partes Review of U.S. Patent No. 8,349,157
`(P.T.A.B.)
`
`4
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`III. UNDERSTANDING OF APPLICABLE LEGAL STANDARDS
` Although I am not an attorney, I have a general understanding of the
`
`applicable legal standards pertaining to the patentability issues presented in this
`
`proceeding based on my experience with patents and my discussion with counsel.
`
`
`
`I understand that, in this inter partes review, Petitioner has the burden
`
`of proving that each challenged claim is unpatentable by a preponderance of the
`
`evidence.
`
`
`
`I understand that a patent claim is unpatentable if, at the time of the
`
`alleged invention, it would have been obvious to one of ordinary skill in the art to
`
`combine the teachings of the prior art to yield the patent claim. I also understand that
`
`it is not required (although it is acceptable) that each element/limitation of a patent
`
`claim be found in a single reference in order to find a patent claim obvious. For a
`
`patent claim to be found obvious, all the elements/limitations of the patent claim
`
`may be found in a combination of references at which a person of ordinary skill in
`
`the art would have been reasonably expected to arrive. I understand that a proper
`
`analysis of whether an invention is unpatentable for obviousness includes a review
`
`of the scope and content of the prior art, the differences between the patent claims at
`
`issue and the prior art, the level of ordinary skill in the field of the invention at the
`
`time of the alleged invention, and other objective considerations identified below.
`
`5
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`
`
`I understand that a showing of obviousness requires some articulated
`
`reasoning with a rational underpinning to support the combination of the references.
`
`I understand that in consideration of the issue of obviousness it is important to
`
`identify whether a reason existed at the time of the alleged invention that would have
`
`led a person of ordinary skill in the pertinent art to combine elements of the
`
`references in a way that yields the claimed invention. I also understand that there
`
`must have been a reasonable expectation of success in combining the references.
`
`
`
`I understand that a claim may be considered unpatentable for
`
`obviousness for various reasons. I have been informed that the following exemplary
`
`rationales may support a finding of obviousness:
`
`(A) combining prior art elements according to known methods to yield
`predictable results;
`(B) simply substituting one known element for another to obtain predictable
`results;
`(C) use of a known technique to improve similar devices in the same way;
`(D) applying a known technique to a known device ready for improvement
`to yield predictable results;
`(E) choosing from a finite number of identified, predictable solutions with a
`reasonable expectation of success;
`(F) known work in a field that prompts variations in the work in the same or
`a different field that leads to predictable results; and
`(G) some teaching, suggestion, or motivation in the prior art that would have
`led a person of ordinary skill in the art to modify a prior art reference or
`combine multiple prior art references or teachings to arrive at the
`claimed invention.
`
`6
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`
`
`I understand that various objective or “real world” factors may be
`
`indicative of non-obviousness. I understand that such factors include:
`
`(A)
`(B)
`
`the commercial success of the claimed invention;
`the existence of a long-felt, unresolved need for a solution to the
`problem solved by the claimed invention;
`(C) failed attempts to solve the problem solved by the claimed invention;
`(D) copying of the claimed invention;
`(E) unexpected results of the claimed invention;
`(F) praise for the claimed invention by others in the relevant field; and
`(G) willingness of others to accept a license under the patent because of the
`merits of the claimed invention.
`I am unaware of any information that would provide secondary
`
`
`
`considerations of non-obviousness for claim 18 of the 452 Patent. However, to the
`
`extent that DexCom (or its expert) provides opinions and/or analysis with respect to
`
`this topic, I reserve the right to supplement my opinions and analyses on this topic.
`
`IV. TECHNOLOGY BACKGROUND
` The 452 Patent relates generally to systems and methods for measuring
`
`an analyte in a host. EX1001 at Abstract. The 452 Patent describes an “analyte” as
`
`“a substance or chemical constituent in a biological fluid … that can be analyzed”
`
`(id. at 12:43-45) and spends much of its disclosure focused on glucose sensors (see,
`
`e.g., id. at 22:60-64) including some discussion regarding calibration (see, e.g., id.
`
`at 82:6-11).
`
`7
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
` For purposes of illustration, I provide brief backgrounds on continuous
`
`glucose monitors (“CGMs”), electrochemistry, and calibration in the context of
`
`analyte sensors below, from the perspective of a person of ordinary skill in the art
`
`(“POSITA”) (which I define below in Section VI and the state of the art as it existed
`
`prior to (the earliest date to which the ’452 Patent claims priority) February 22, 2006.
`
` Background of Continuous Glucose Monitor Sensors
` Periodic measurement of the amount of glucose in the blood is
`
`important for people with diabetes to avoid complications of excessively low or high
`
`blood glucose and to control their glucose levels. Historically, single-use test strips
`
`were used to monitor glucose levels of patients, using a process generally referred
`
`to as blood glucose measurement (“BGM”).1 Using these test strips, the patient
`
`would insert a test strip into a device reader, prick his or her finger (referred to as a
`
`“finger prick” or “finger stick”), draw a drop of blood onto the test strip, and read
`
`the glucose results from the blood sample on a screen of the device reader. Patients
`
`would repeat these steps multiple times per day to monitor their blood glucose levels.
`
`
`1 Glucose concentrations are generally expressed either in milligrams per deciliter
`
`(mg/dL), with normal values of about 70-100 mg/dL, or in millimoles per liter
`
`(mmol/L), with normal levels of about 4-6 mmol/L. 1 mmol/L is equal to 18 mg/dL.
`
`8
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`If needed, the patient would take oral medications or receive insulin injections as
`
`necessary to control glucose levels and to address any glucose excess.
`
` However, it is well established that glucose levels change based on food
`
`intake and other effects. These effects take time to manifest, and thus, may not be
`
`reflected in a patient’s blood glucose measurement. This lag in the timing of the
`
`glucose reading can cause patients to inject themselves with more or less insulin than
`
`is necessary. For this reason, the potential benefits of being able to continuously
`
`monitor a patient’s glucose levels have been recognized for a long time.
`
` Around the late 1990s, a commercial version of a continuous glucose
`
`monitor (“CGM”) became available. Until about 2004, these devices collected blood
`
`glucose information from the patient for review by a medical professional.
`
` CGMs generally work by placing an electrochemical sensor through the
`
`skin and into the interstitial fluid under a patient’s skin. The sensor extends out
`
`through the skin and is connected to an electronic device adhered to the surface of
`
`the skin. The sensor produces an electrical current that varies depending on changes
`
`in the patient’s glucose concentration within a range of interest. Because the amount
`
`of current generated by the sensor is not itself meaningful to a patient, the sensor
`
`current is converted to an estimated glucose concentration, which is then displayed
`
`to the patient.
`
`9
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
` Typically, in these sensors, a voltage is applied between two specially
`
`configured conductive electrodes (as I explain in more detail below), and the amount
`
`of current flowing between the electrodes is proportional to glucose concentration.
`
`The current is converted into typical units of conventional glucose concentrations,
`
`such as mg/dL and mmol/L. As such, CGMs can be used for diabetes management
`
`purposes by monitoring a patient’s glucose concentration and comparing it to target
`
`values.
`
`
`
`Electrochemistry Background
` To measure a substance using electrochemical techniques, two
`
`electrodes (an anode and a cathode) are placed in a conductive medium with one
`
`electrode operating as a “working electrode” and one electrode operating as a
`
`“reference electrode.” In some electrochemical measurements, three electrodes are
`
`used, and the third electrode is referred to as a “counter electrode.” Depending upon
`
`the analyte to be measured, the working electrode can be an anode (such as for
`
`measurement of blood glucose), which has a positive voltage applied to it, and a
`
`substance in the solution is oxidized at that electrode to create the measured current.
`
`Alternatively, the working electrode can be a cathode, which has a negative voltage
`
`applied to it, and a substance in the solution is reduced at that electrode to create the
`
`measured current. The current is generally measured in amperes (usually expressed
`
`10
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`as “microamps” or “nanoamps”), but some systems use an analog-to-digital
`
`converter that transforms the current signal into digital “counts.”
`
`
`
`In electrochemical measurements, no current flows until the potential
`
`applied to the working electrode reaches a value characteristic of a material in
`
`solution to be measured (the “analyte”), which is known as the “oxidation potential”
`
`for an anode working electrode or the “reduction potential” for a cathode working
`
`electrode. At that potential (and at reasonably higher potentials), the amount of
`
`current generated depends on the amount of material that reaches the electrode
`
`surface and reacts there to transfer electrons. Thus, the generated current is
`
`proportional to the concentration of the analyte in solution being oxidized or
`
`reduced.
`
`
`
`In some cases, a second material can also undergo reaction at the same
`
`potential as the analyte and generate current that is not related to the concentration
`
`of the analyte. This second material is considered an “interferent,” and is generally
`
`determined (or its effect eliminated) by making a “baseline” measurement with the
`
`analyte absent, or at another potential.
`
` One method of using the sensors to measure glucose in body fluid
`
`requires a two step-process. First, an enzyme, such as glucose oxidase, catalyzes a
`
`reaction with glucose, oxygen, and water to form an equivalent amount of hydrogen
`
`peroxide. Second, the hydrogen peroxide formed is measured electrochemically—it
`
`11
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
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`

`

`
`
`is oxidized to oxygen, releasing electrons to the electrode that result in a flow of
`
`current. The resulting current correlates to the concentration of glucose that was
`
`present in the fluid as the hydrogen peroxide generated is directly related to the
`
`concentration of glucose.
`
` Calibration Background
` A CGM’s sensor must first be calibrated to measure glucose levels. As
`
`noted by the ’452 Patent, sensor calibration is “the process of determining the
`
`relationship between the sensor data and the corresponding reference data, which
`
`can be used to convert sensor data into meaningful values substantially equivalent
`
`to the reference data.” EX1001 at 18:37-44. This relationship is often referred to as
`
`a “conversion” or a “calibration” function. A conversion function includes various
`
`calibration parameters such (1) a “sensitivity” which relates a change in sensor
`
`signal (such as current) to a change in glucose concentration, and (2) a “baseline”
`
`(also known as “background,” “noise,” or “offset”) that accounts for any baseline
`
`current generated by the sensor when no glucose is detected.2
`
` A conversion function that accounts for sensitivity and baseline for a
`
`glucose sensor can take the form of a basic linear equation:
`
`
`2 The noise and sensitivity can differ among sensors, causing each sensor to produce
`
`a different electrical output for the same glucose concentration of a patient.
`
`12
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

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`
`
`y = mx + b
`
`where:
`
`
`
`
`
`
`
`
`
`y is the sensor signal (in units such as amps or digital “counts”);
`
`x is the estimated glucose concentration (in units such as mg/dL);
`
`m is the sensor’s sensitivity to glucose; and
`
`b is the baseline signal.
`
`Other conversion functions (such as non-linear functions) can be used, depending
`
`on the particular sensor, and conversion functions can account for additional or other
`
`parameters (such as, for example, temperature).
`
`V. The 452 Patent
` The 452 Patent, entitled “Analyte Sensor,” “relates generally to systems
`
`and methods for measuring an analyte in a host” and describes various embodiments
`
`for calibrating a glucose sensor. EX1001 at 1:30-33, 81:63-90:12, 1:49-51.
`
` Calibration Using Reference Measurements
` The 452 Patent describes embodiments for performing sensor
`
`calibration. Id. at 98:4-22, 84:6-30. However, the patent’s description of how to
`
`calibrate did not go beyond that which was already well-known to those skilled in
`
`the art. By 2005, a POSITA already would have known various calibration methods,
`
`including (1) determining a “conversion function” based on the relationship between
`
`13
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
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`the sensor signal and certain “reference” measurements and (2) using prior
`
`calibration information and predictive relationships to calibrate sensors.
`
`
`
`
`
`Priority Claims and Prosecution History
`I understand that the application that issued as the 452 Patent was filed
`
`as Application No. 17/088,396 (the “396 Application”) on November 3, 2020.
`
`EX1001 at p. 1 (21) & (22). The 452 Patent claims priority to what I understand are
`
`seven earlier-filed applications. See id. at p. 1. I understand that the earliest priority
`
`claim is to Application No. 11/360,262, which was filed on February 22, 2006. See
`
`id.
`
`
`
`I have reviewed the analysis of the Leinsing declaration regarding the
`
`file history of the 452 Patent.
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART
`
`I understand that the content of a patent (including its claims) and prior
`
`art should be interpreted the way a person of ordinary skill in the art (or “POSITA”)
`
`would have interpreted the material at the time of the alleged invention.
`
` For the purposes of this declaration, I will assume that February 22,
`
`2006 is the appropriate priority date and “time of the alleged invention” when
`
`discussing the knowledge of a POSITA, unless otherwise indicated.
`
`14
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
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`

`

`
`
` With respect to the relevant art, the “Background of the Invention”
`
`section (EX1001 at 1:35-2:17) disclosed in the challenged 452 Patent provides
`
`examples of the state of the art as of the 452 Patent’s priority date.
`
`
`
`I have reviewed the Leinsing Declaration and understand and agree that
`
`a POSITA as of the claimed priority date would have had a Bachelor’s degree in
`
`biomedical engineering, mechanical engineering, chemical engineering, or materials
`
`science and engineering (or a related or equivalent field), and two or more years of
`
`experience researching, developing, designing, and/or evaluating (or supervising the
`
`same) medical devices for measuring analyte levels, e.g., analyte sensors, or
`
`equivalent experience. A person with less or different education but more relevant
`
`practical experience, or vice versa, may also meet this standard. EX1003, ¶¶17-21.
`
`The prior art also evidences the level of skill in the art.
`
` A POSITA may be part of an interdisciplinary team with others having
`
`the relevant experience set forth above and/or with clinicians involved in diagnosis,
`
`treatment, and patient management relevant to the use of medical devices for
`
`measuring analyte levels, e.g., analyte sensors. Id.
`
`
`
`In addition to my testimony as an expert, I am prepared to testify as
`
`someone who actually practiced in the field for 30 years, who actually possessed at
`
`least the knowledge of a POSITA within that time period, and who actually worked
`
`with others possessing at least the knowledge of a POSITA within that time period.
`
`15
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`
`
`I understand that the POSITA is a hypothetical person who is assumed
`
`to be aware of all pertinent information that qualifies as prior art. In addition, a
`
`POSITA makes inferences and uses ordinary creativity. Based on my education,
`
`knowledge and experience, I meet this definition of a POSITA.
`
`VII. OTHER OPINIONS RELIED ON
`
`It is my opinion that experts in this field reasonably rely on opinions of
`
`other members of their interdisciplinary teams in forming their own opinions on this
`
`subject. Accordingly, I have relied on the opinions set forth in the Leinsing
`
`Declaration in forming my opinions herein.
`
`VIII. PRIOR ART RELIED ON IN PETITION
` References Relied on by Mr. Leinsing
`
`I understand that Mr. Leinsing has relied on the following references in
`
`forming his opinions:
`
` Cheney (EX1005)
`
` Lord (EX1006)
`
` Gross (EX1024)
`
` Shah (EX1019)
`
` Taniguchi (EX1007)
`
` Funderburk (EX1016)
`
` Z-Carbon (EX1009)
`
`16
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
` Zebra References (see table below)
`
`Exhibit
`1009
`
`1010
`
`1011
`
`1034
`
`1051
`
`Title
`Z-Carbon
`Connector (“Carbon
`Connector
`Publication”)
`
`Z-Silver Connector
`(“Silver Connector
`Publication”)
`
`Fuji Polymer Indus.
`Co., New High
`Performance Silver
`ZEBRA®
`Connector, Data
`Sheet No. FPDS 01-
`34/Version 5 (Jan.
`9, 2007)
`
`Fujipoly®,
`ZEBRA®
`Elastomeric
`Connectors, Carbon
`(Copyright 2003)
`
`Fuji Polymer Indus.
`Co., New High
`Performance Silver
`ZEBRA®
`Connector, Data
`Sheet No. FPDS 01-
`34/Version 2
`(January 31, 2002)
`
`Pub. Date
`December
`11, 2004
`
`Disclosure
`p. 1 (conductive layer
`durometer value is 60 Shore A,
`non-conductive layer
`durometer is 50 Shore A)
`
`July 9, 2004
`
`p. 1 (same as EX1009)
`
`January 9,
`2007
`
`
`Table 8 (describing “ZEBRA®
`Connector” having a silicone
`based conductive layer (i.e.,
`electrical contact) with Shore
`A hardness of 80, non-
`conductive layer Shore A
`hardness of 30)
`
`March 14,
`2005
`
`p. 1 (Zebra connector
`insulating barrier durometer
`hardness 30)
`
`Version Date
`January 31,
`2002;
`January 31,
`2002
`
`
`Table 8 (describing “ZEBRA®
`Connector” having a silicone
`based conductive layer (i.e.,
`electrical contact) with Shore
`A hardness of 80, non-
`conductive layer Shore A
`hardness of 30)
`
`1052
`
`Fuji Polymer Indus.
`Co., New High
`Performance Silver
`
`Version Date
`January 16,
`2006;
`
`Table 8 (describing “ZEBRA®
`Connector” having a silicone
`based conductive layer (i.e.,
`
`17
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`January 16,
`2006
`
`ZEBRA®
`Connector, Data
`Sheet No. FPDS 01-
`34/Version 5
`(January 16, 2006)
`
`electrical contact) with Shore
`A hardness of 80, non-
`conductive layer Shore A
`hardness of 30)
`
` Durometer Hardness Properties of Elastomeric Materials (see
`
`
`
`Exhibit
`1008
`
`table below)
`
`Citation
`Kreith, Frank, “The
`CRC Handbook of
`Mechanical
`Engineering
`Handbook” (1997)
`
`Pub. Date
`March 27,
`1998
`
`Disclosure
`pp. 12-33 (40-85 Shore
`hardness for polysulfide
`rubbers; 35-100 Shore
`hardness for polyurethane
`rubbers; 30-90 Shore A
`hardness for Silicone rubbers;
`40-80 hardness for
`fluorosilicone rubbers)
`
`pp. 319-321 (Tables 4.8, 4.9,
`and 4.10 disclosing various
`silicone elastomers within the
`claimed range)
`
`pp. 41, 92 (“Silicone” seals –
`which are elastomers – have a
`“Hardness (Shore A): 25 to 80
`[±5]”; “Silicone ... Key Uses:
`... Seals for medical devices,
`compatible with FDA
`regulations ... Hardness (Shore
`A): 25 to 80”)
`
`July 9, 1998
`
`June 24,
`2003
`
`1012
`
`1013
`
`1014
`
`HANDBOOK OF
`BIOMATERIAL
`PROPERTIES
`319─322 (Hastings
`& Black Eds., 1998)
`
`Apple Rubber
`Citation to Apple
`Rubber Products,
`Seal Design Guide,
`https://www.appleru
`bber.com/sdc
`(1999) (accessed via
`archive.org May 5,
`2021)
`
`SILASTIC®
`MDX4-4210 DOW
`CORNING
`
`August 8,
`2005
`
`p. 1 (“Durometer Hardness -
`Shore A 30”) [silicone])
`
`18
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`November
`30, 1999
`
`p. 3 (“Silicone rubbers have ...
`a durometer range of 5 to 80
`Shore A.”)
`
`App. X1.2 (“generally
`recognized that durometer
`hardness determination below
`20 and above 90 are
`unreliable”); Table X1.1
`(listing “soft vulcanized
`rubber, natural rubber, nitriles,
`thermoplastic elastomers,
`flexible polyacrylics and
`thermosets, wax, felt, and
`leathers” as typical examples
`of A scale materials with a
`durometer hardness between
`20-90 Shore A)
`p. 1045 (“It is apparent that,
`with increasing the amount of
`different blacks, both
`conductivity and hardness of
`the composites increase.”);
`Table II (listing various mix
`shore A hardness values
`ranging from 25-70 Shore A)
`
`¶64 (referencing the use of
`Fujipoly elastomeric zebra
`connectors in an analyte
`sensor)
`
`¶51 (referencing the use of Z-
`axis and Fujipoly elastomeric
`
`1015
`
`1020
`
`Specification Sheet
`(2005)
`
`Heide, Charles,
`Silicone Rubber for
`Medical Device
`Applications (1999)
`
`ASTM
`International,
`“Standard Test
`Method for Rubber
`Property—
`Durometer
`Hardness” (2005)
`
`September
`30, 2005
`
`1022
`
`June 30,
`1998
`
`K. G. Princy et al.,
`Studies on
`Conductive Silicone
`Rubber Compounds,
`69 J. APPLIED
`POLYMER SCI. 1043
`(1998)
`
`1031
`
`1032
`
`U.S. Patent App.
`No. 2006/0011474
`(“Schulein”)
`
`U.S. Patent App.
`No. 2002/0032531
`(“Mansky”)
`
`2006
`
`2002
`
`19
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022-00917
`
`

`

`
`
`zebra connectors in an analyte
`sensor)
`
` Gross (EX1024)
`
`I understand that U.S. Patent No. 6,275,717, entitled “Device and
`
`method of calibrating and testing a sensor for in vivo measurement of an analyte”
`
`and granted to Gross et al. (“Gross”) was filed on June 23, 1998. EX1024. Gross
`
`claims priority to a foreign application filed on June 16, 1997, and Gross issued as a
`
`U.S. patent on August 14, 2001. Id. I understand from counsel that, because Gross
`
`was published more than a year prior to the earliest claimed priority of the 452
`
`Patent, Gross qualifies as prior art to the 452 Patent at least under 35 U.S.C. § 102(b).
`
`
`
`I understand that DexCom included Gross in an Information Disclosure
`
`Statement during prosecution of the 452 Patent with over 3,705 references (see
`
`EX1002 at pp. 306, 270-488), but the Examiner did not cite to Gross to reject the
`
`claims.
`
`
`
`I have reviewed the specification and figures described in Gross. Gross
`
`discloses an analyte monitor device and methods for calibrating the device (and
`
`sensors). EX1024 at 2:33-8:55, 10:60-14:61. Gross notes that the
`
`advantages of having a reliable alternative method of measuring
`glucose in vivo are plain given the number of diabetics for
`whom blood sampling tests several times daily are a fact of life.
`The most common method of blood sampling currently in use
`
`20
`
`Exhibit 1043
`Abbott Diabetes Care Inc. v. Dexcom Inc.
`IPR2022