`FOR THE EASTERN DISTRICT OF TENNESSEE
`GREENEVILLE DIVISION
`
`
`DENTSPLY INTERNATIONAL INC.
`and TULSA DENTAL PRODUCTS LLC
`d/b/a TULSA DENTAL SPECIALTIES
`
`
`Plaintiffs,
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`v.
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`US ENDODONTICS, LLC
`
`
`Defendant.
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`Civil Action No. 2:14-cv-00196
`Judge J. Ronnie Greer
`Magistrate Judge Dennis H. Inman
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`HIGHLY CONFIDENTIAL
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`
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`
`
`EXPERT REPORT OF ROBERT SINCLAIR, PH.D.
`
`I.
`
`INTRODUCTION
`
`1.
`
`I, Robert Sinclair, Ph.D., have been retained by Plaintiffs Dentsply International
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`Inc. and Tulsa Dental Products LLC d/b/a Tulsa Dental Specialties (collectively “Plaintiffs” or
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`“Dentsply”) to serve as an expert witness in the above-captioned matter. I expect to testify
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`regarding the matters discussed in this report as well as any supplemental report that I may later
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`submit and to respond to any testimony that Defendant US Endodontics, LLC (“US Endo”) may
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`offer at the preliminary injunction hearing.
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`II.
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`BACKGROUND AND QUALIFICATIONS
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`2.
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`I hold a B.A. in Materials Science (1968) and a Ph.D. in Materials Science
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`(1972), both from Cambridge University. After receiving my Ph.D., I worked from 1973-1977 as
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`a Postdoctoral Research Engineer at the University of California, Berkeley.
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`3.
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`Since 1977, I have been employed at Stanford University in Stanford, California,
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`where I have successively served as Assistant Professor in Materials Science and Engineering
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`1 of 7
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`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
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`
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`37.
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`The property imputed to the instrument as a result of step (b) in the ‘773 patent is:
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`“wherein the heat-treated shank has an angle greater than 10 degrees of permanent deformation
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`after torque at 45º flexion when tested in accordance with ISO Standard 3630-1.”
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`C.
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`38.
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`Independent Testing of the EdgeFiles
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`I have reviewed and am familiar with the results of the thermal testing (DSC)
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`conducted on each of the EdgeFiles by Veritas.
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`39.
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`Samples of EdgeFiles were provided to Veritas as unopened packages of 3 or 6
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`files in the form in which they are commercially available. Prior to testing, each file was cut
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`from the tip of the EdgeFiles for each specimen into small segments using a diamond saw.
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`Segments of sample material of approximately 5 mm were found to weigh between 5-15
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`milligrams.
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`40.
`
`The DSC testing performed by Veritas utilized a PerkinElmer DSC6000 with an
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`Intracooler 2 instrument. The instrument was calibrated to the manufacturer’s specifications
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`using indium and zinc standard supplied by the manufacturer. Each sample was placed in the
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`DSC instrument, and that the instrument was cooled to -65 ºC for 1 minute before increasing the
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`temperature at 10 ºC per minute until reaching 100 ºC. Samples of each EdgeFile type (X1, X3,
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`X5, X7, and XR) were tested in triplicate.
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`41.
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`The DSC curves showing the results of the thermal analysis of the EdgeFiles were
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`provided. The table below provides a key to the samples tested and the results. The procedure in
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`the ASTM standard was utilized to calculate the As, Af, Ms, and Mf data points.
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`2 of 7
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`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
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`
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`Product
`
`Size Length
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`EdgeFile X1 25.06 25 mm
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`EdgeFile X3
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`N2
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`25 mm
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`R-Phase
`start
`temp
`(Rs)
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`martensite
`start temp
`(Ms)
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`R-Phase
`finish
`temp
`(Rf)3
`
`martensite
`finish
`temp (Mf)4
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`28 °C
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`28 °C
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`27 °C
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`29 °C
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`29 °C
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`28 °C
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`28 °C
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`-17 °C
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`-18 °C
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`-18 °C
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`-37 °C
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`-37 °C
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`-38 °C
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`-20 °C
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`-19 °C
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`21 °C
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`22 °C
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`21 °C
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`21 °C
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`19 °C
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`20 °C
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`22 °C
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`22 °C
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`-35 °C
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`-36 °C
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`-36 °C
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`-51 °C
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`-58 °C
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`-51 °C
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`-39 °C
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`-39 °C
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`DSC
`Curve2
`22714011
`Sample 1
`22714011
`Sample 2
`22714011
`Sample 3
`20614010
`Sample 1
`20614010
`Sample 2
`20614010
`Sample 3
`81913031
`Sample 1
`81913031
`Sample 2
`81913031
`Sample 3
`31014023
`Sample 1
`31014023
`Sample 2
`31014023
`Sample 3
`22714092
`Sample 1
`22714092
`Sample 2
`22714092
`Sample 3
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`EdgeFile X5 40.04 25 mm
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`EdgeFile X7 35.06 25 mm
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`EdgeFile XR
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`R4
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`23 mm
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`27 °C
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`27 °C
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`29 °C
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`28 °C
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`29 °C
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`-19 °C
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`-19 °C
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`-19 °C
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`-20 °C
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`3 °C
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`0 °C
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`1 °C
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`22 °C
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`23 °C
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`22 °C
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`22 °C
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`-38 °C
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`-37 °C
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`-37 °C
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`-36 °C
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`-38 °C
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`-45 °C
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`-42 °C
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`42.
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`Veritas also provided a supplemental analysis in which one DCS curve from each
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`file tested was reproduced with the austenite finish temperature determination included. The
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`2 The number corresponds to the Lot number on the packaging.
`3 This value was calculated by hand.
`4 This value was calculated by hand.
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`3 of 7
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`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
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`
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`table below provides a key to the supplemental DSC curves. The procedure in the ASTM
`
`standard was utilized to calculate the As, Af, Ms, and Mf data points.
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`Product
`
`Size
`
`Length
`
`Lot
`
`EdgeFile X1
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`25.06
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`EdgeFile X3
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`N2
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`EdgeFile X5
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`EdgeFile X7
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`40.04
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`35.06
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`EdgeFile XR
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`R4
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`25 mm
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`25 mm
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`25 mm
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`25 mm
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`23 mm
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`22714011
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`20614010
`
`81913031
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`31014023
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`22714092
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`DSC Curve
`22714011
`Sample 1
`20614010
`Sample 3
`81913031
`Sample 2
`31014023
`Sample 3
`22714092
`Sample 1
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`Austenite
`finish temp
`(Af)
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`39 °C
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`35 °C
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`37 °C
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`41 °C
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`4 °C
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`43.
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`I have reviewed and am familiar with mechanical testing conducted on each of the
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`EdgeFiles by Knight Mechanical. A report on the mechanical bend testing performed by Knight
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`Mechanical in accordance with ISO Standard 3630-1 was provided. Samples of the EdgeFiles
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`were provided to Knight Mechanical as unopened packages of 3 or 6 files in the form in which
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`they are commercially available.
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`44.
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`A device was assembled in accordance with ISO Standard 3630-1 and a stiffness
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`test was conducted in accordance with Section 7.5. After the stiffness test was completed, the
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`files were measured for any angle of permanent deformation. The table below provides a key to
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`the samples tested and the results.
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`Size Length Sample
`Product
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`X1_S1
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`EdgeFile X1 25.06
`25 mm X1_S2
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`
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`X1_S3
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`X3_S1
`EdgeFile X3 N2
`25 mm X3_S2
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`Torque at 45°
`Angular
`Displacement
`(mN·m)
`3.60
`3.53
`3.35
`0.93
`0.91
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`Post-testing Permanent
`Deformation Angle
`(degrees)
`23.75
`27.00
`27.33
`1.83
`3.58
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`4 of 7
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`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
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`EdgeFile X5 40.04
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`EdgeFile X7 35.06
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`EdgeFile XR R4
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`X3_S3
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`X5_S1
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`25 mm X5_S2
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`X5_S3
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`X7_S1
`25 mm X7_S2
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`X7_S3
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`XR_S1
`23 mm XR_S2
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`XR_S3
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`1.35
`5.46
`4.85
`4.98
`6.49
`7.43
`7.44
`3.76
`3.43
`4.24
`
`2.17
`13.50
`11.75
`19.83
`29.00
`29.08
`26.67
`1.00
`0.25
`0.42
`
`D.
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`45.
`
`Defendant US Endo’s Heat Treatment Process
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`In his August 1, 2014 declaration, Mr. Bobby Bennett states that US Endo
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`receives fluted, nickel titanium endodontic files from a third-party supplier, and then heat-treats
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`the files in an industrial oven for the manufacture of EdgeFiles X1, X35, X5, and X7. (Bennett
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`Declaration signed August 1, 2014 at ¶¶ 7, 8, 12, 13).
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`46.
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`Documents produced by US Endo outline the processing steps for the heat
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`treatment of the EdgeFiles in more detail. First, the oven is warmed to a “proprietary
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`temperature.” See, e.g., USENDO0000006 (Sequence # 4); USENDO0000011 (Sequence # 7).
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`Next, the files are loaded into a metal tubes (USENDO0000006 (Sequence # 5)), and the tubes
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`are loaded into the oven. USENDO0000007 (Sequence # 6). The oven door is shut and the tubes
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`containing the entire files are heated for a period of time, which is recorded on a corresponding
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`product router document. USENDO0000007 (Sequence # 7-9). The date, tube number, and time
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`log for each heat treatment is recorded in the US Endo Heat Treat Log. See USENDO0000129-
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`USENDO0000179. The quantities of files that are heat-treated, as well as the time of the day in
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`which the tubes containing the files are loaded into and taken out of the oven, are recorded on
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`US Endo Product Router documents. See, e.g., USENDO0000201.
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`5 Mr. Bennett states that there is one type of the X3 EdgeFile having a specific taper that is not
`heat-treated; however, he admits that other X3 EdgeFiles are heat-treated.
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`5 of 7
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`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
`
`
`
`E.
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`Comparison of the EdgeFiles with Claim 1 of the ‘773 Patent
`
`Step 1: “providing”
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`51.
`
`According to the declaration of Mr. Bobby Bennett of August 1, 2014, EdgeFiles
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`X1, X5, and X7 are fluted, nickel titanium files that are heat-treated, whereas EdgeFile XR is a
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`fluted, nickel-titanium file that is not treat-treated.
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`52.
`
`As shown by the mechanical bend testing results, the EdgeFile XR does not
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`demonstrate permanent deformation when subjected to the testing in standard ISO 3630-1. See
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`supra at 54. In other words, when a bending force is applied to EdgeFile XR and subsequently
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`released, the file will spring back straight rather than remain permanently deformed. Thus, the
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`EdgeFile XR is superelastic. It follows that EdgeFiles X1, X5, and X7—which are fluted, nickel
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`titanium files when received by US Endo—are also superelastic.
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`53.
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`Accordingly, it follows that US Endo’s process for manufacturing the EdgeFiles,
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`or at least the EdgeFiles X1, X5, and X7, includes the first step in the ‘773 patent: “(a) providing
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`an elongate shank having a cutting edge extending from a distal end of the shank along an axial
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`length of the shank, comprising a superelastic nickel titanium alloy.” In other words, before heat
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`treatment, the EdgeFiles have a cutting edge and comprise a superelastic nickel titanium alloy.
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`Step 2: “heat-treating”
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`54.
`
`The product packaging for Edge Endo’s EdgeFiles X1, X5 and X7 indicate that
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`the products are “HEAT TREATED NiTi FILES.”
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`55.
`
`The August 1, 2014 declaration submitted by Mr. Bobby Bennett states that the
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`EdgeFiles are prepared by heat-treating nickel titanium files.
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`56.
`
`The procedure outlined in the US Endo documents call for the following steps:
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`load the files into tubes; load the tubes into the oven; and close the oven door. See
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`6 of 7
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`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
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`
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`7 of 7
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`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner