`FOR THE EASTERN DISTRICT OF TENNESSEE
`GREENEVILLE DIVISION
`
`DENTSPLY INTERNATIONAL INC.
`and TULSA DENTAL PRODUCTS LLC
`d/b/a TULSA DENTAL SPECIALTIES
`
`Plaintiffs,
`
`v.
`
`US ENDODONTICS, LLC
`
`Defendant.
`
`Civil Action No. 2:14-cv-00196
`Judge J. Ronnie Greer
`Magistrate Judge Dennis H. Inman
`
`HIGHLY CONFIDENTIAL
`
`EXPERT REPORT OF ROBERT SINCLAIR, PH.D.
`
`I.
`
`INTRODUCTION
`
`1.
`
`I, Robert Sinclair, Ph.D., have been retained by Plaintiffs Dentsply International
`
`Inc. and Tulsa Dental Products LLC d/b/a Tulsa Dental Specialties (collectively "Plaintiffs" or
`
`"Dentsply") to serve as an expe1t witness in the above-captioned matter. I expect to testify
`
`regarding the matters discussed in this repmt as well as any supplemental repmt that I may later
`
`submit and to respond to any testimony that Defendant US Endodontics, LLC ("US Endo") may
`
`offer at the preliminary injunction hearing.
`
`II.
`
`BACKGROUND AND QUALIFICATIONS
`
`2.
`
`I hold a B.A. in Materials Science (1968) and a Ph.D. in Materials Science
`
`(1972), both from Cambridge University. After receiving my Ph.D., I worked from 1973-1977 as
`
`a Postdoctoral Research Engineer at the University of California, Berkeley.
`
`3.
`
`Since 1977, I have been employed at Stanford University in Stanford, California,
`
`where I have successively served as Assistant Professor in Materials Science and Engineering
`
`1
`
`GOLD STANDARD EXHIBIT 2019
`US ENDODONTICS v. GOLD STANDARD
`CASE PGR2015-00019
`
`
`
`(1977-1980), Associate Professor with tenure in Materials Science and Engineering (1980-1984)
`
`and Professor of Materials Science and Engineering (1984 to Present). In 2009, I was appointed
`
`the Charles M. Pigott Professor in the School of Engineering at Stanford University.
`
`4.
`
`Currently I am a Professor in the Materials Science and Engineering Department
`
`at Stanford University. I served as the chair of the Materials Science and Engineering
`
`Department at Stanford University from September 1, 2004 through August 31, 2014. From 2002
`
`to 2013, I was the Director of the Stanford Nanocharacterization Laboratory, and from 2010-
`
`2012, I was the Director of the Bing Overseas Studies Program at Stanford University. I have
`
`had a number of appointments as a Visiting Professor at institutions around the world, including
`
`the HREM Laboratory at Cambridge University in the United Kingdom and Matsushita Electric
`
`Industrial Company in Japan.
`
`5.
`
`I have authored more than 225 scientific research papers, published over 190
`
`articles at national and international scientific meetings, and made over 500 presentations at
`
`conferences, university departments, and research laboratories world-wide. My publications,
`
`which are listed on my curriculum vitae attached hereto as Exhibit A, are in the areas of
`
`materials science, and include investigations on the properties of nickel-titanium alloys. I have
`
`also authored and/or edited several books and book chapters, and I hold two patents.
`
`6.
`
`I have served as a member on the Editorial Board for the Journal of Applied
`
`Physics (1994-1996) and the Journal of Electron Microscopy (1996-present), among other
`
`journals. I routinely review articles for scholarly journals.
`
`7.
`
`I have taught more than 6,000 students in undergraduate and graduate courses,
`
`including, among others, Introduction to Materials Science; Imperfections in Crystalline Solids;
`
`Atomic Arrangements in Solids; Nanostructure and Characterization; X-ray Diffraction
`
`2
`
`
`
`Laboratory; Nano-Characterization of Materials; Transmission Electron Microscopy; and
`
`Microscopic World of Technology.
`
`8.
`
`My current research interests are in the structure-property-processing correlations
`
`in materials, using high-resolution microscopy and diffraction techniques, application to
`
`development of integrated circuit and magnetic recording materials and introduction of in situ
`
`high resolution electron microscopy. This includes their application to understanding phase
`
`transformations and deformation of nitinol alloys, correlated with Differential Scanning
`
`Calorimetry (DSC) analysis.
`
`9.
`
`Throughout the course of my career, I have received various honors and awards,
`
`as described in detail my curriculum vitae. Some of the awards I have received include the
`
`Robert Lansing Hardy Gold Metal from the Metallurgical Society of AIME in 1976, the Alfred
`
`P. Sloan Foundation Fellowship in 1979, the Distinguished Scientist Award (Physical Sciences)
`
`from the Microscopy Society of America in 2009, and the David M. Turnbull Lectureship Award
`
`from the Materials Research Society in 2012.
`
`10.
`
`Based on my experience and qualifications, I am qualified to render opinions in
`
`the field of nickel-titanium alloys. I am an expert in the field of materials science and
`
`engineering, particularly in electron microscopy and material structure and phase
`
`transformations, with several well-cited articles on the behavior of nitinol alloys.
`
`11.
`
`I have been retained by Rothwell, Figg, Ernst & Manbeck, P.C. as an expert
`
`witness in this litigation. I am being compensated at my regular consulting rate of $600 per hour
`
`for time spent consulting, plus expenses. My compensation is not dependent on the opinions
`
`expressed or the outcome of this litigation. In addition, I am an independent consultant and am
`
`not connected in any way to the parties involved in this litigation.
`
`3
`
`
`
`12.
`
`I have not provided any expert testimony in the last four years.
`
`III. MATERIALS REVIEWED
`
`13.
`
`The opinions expressed herein are based on data, documents, and information
`
`currently available to and reviewed by me. In forming my opinions, I have considered the
`
`documents and information cited herein and listed in Exhibit B, attached hereto. I have also
`
`relied on my education, background, and experience.
`
`IV.
`
`LEGAL STANDARDS
`
`14. My opinions are based on the legal standards provided to me by Counsel. I
`
`understand that the following legal standards apply with respect to assessing patent infringement.
`
`15.
`
`It is my understanding that the question of infringement must be considered on a
`
`claim by claim basis, that is, each claim must be considered individually, and that a patent claim
`
`may be directly infringed in two ways, either literally or under the doctrine of equivalents.
`
`16.
`
`It is my understanding that to literally infringe a patent claim, an accused process
`
`or product must meet every element and limitation of the asserted patent claim.
`
`17.
`
`It is my understanding that if a patent claim is not literally infringed because not
`
`every element and limitation is met, a patent claim may be infringed under the doctrine of
`
`equivalents if, for each and every claim element or limitation that is not literally present in the
`
`accused process or product, the accused process or product has an equivalent element or
`
`limitation. In order for an element to be deemed equivalent, a person having ordinary skill in the
`
`art must consider it to be insubstantially different from the claimed element. Two elements are
`
`deemed equivalent when (1) perform substantially the same function; (2) in substantially the
`
`same way; and (3) achieve substantially the same result.
`
`4
`
`
`
`18.
`
`I understand that certain determinations are to be analyzed from the perspective of
`
`a “person having ordinary skill in the art,” and that such a person would be involved with the
`
`technology at issue at the time of the claimed invention. Based on my review of the ‘033 patent
`
`and the ‘773 patent, my review of the materials relied on to prepare this report, and my own
`
`research and academic experience, I believe that a person of ordinary skill in the art would have
`
`a high-level understanding of nickel titanium alloys. Such a person would likely have a material
`
`science, metallurgy, or related BS or MS degree and several years of experience; or, a PhD or
`
`related advanced degree and a couple years of experience so as to understand the structural,
`
`chemical and mechanical properties that can be manipulated in nickel titanium alloy materials.
`
`19.
`
`I understand that a person having ordinary skill in the art at the time of invention
`
`relates to the period of when the first patent application was filed. As applied to this case, I
`
`understand that the ‘341 patent and the ‘773 patent claim benefit to an application filed in 2004,
`
`making that the relevant period for understanding what a person having ordinary skill in the art
`
`would have known.
`
`V.
`
`OPINIONS AND BASES THEREFOR
`
`20.
`
`I understand that an action for patent infringement has been filed against US Endo
`
`for the unlawful use of a process claimed in the ‘341 and ‘773 patents.
`
`A.
`
`21.
`
`Background of the Technology
`
`Nickel titanium alloys containing an approximately 50:50 atomic ratio of nickel to
`
`titanium (known as “nitinol”) were first discovered at the Naval Ordnance Laboratory in 1959. In
`
`the 1970s, the first reports of using nitinol in dentistry appeared. See, e.g., Andreasen et al., A
`
`use hypothesis for 55 nitinol wire for orthodontics. Angle Orthod. 1972, 42(2), 172-177;
`
`Andreasen et al., Laboratory and clinical analysis of nitinol wire. Am. J. Orthod. 1978, 73(2),
`
`5
`
`
`
`142-151. There were several years before reports of using nitinol in endodontic hand files
`
`appeared in 1988. See, e.g., Walia et al., An initial investigation of the bending and torsional
`
`properties of Nitinol root canal files. J. Endod. 1988, 14, 346-351. Following the work of Walia
`
`et al., engine-driven rotary endo files were introduced and “achieved widespread popularity.”
`
`Brantley et al., Differential Scanning Calorimetric Studies of Nickel Titanium Rotary Endodontic
`
`Instruments, J. Endo. 2002, 28(8), 567-572.
`
`22.
`
`Despite the improved properties shown by nitinol files as compared to other
`
`materials, such as stainless steel, a well-documented problem reported in the literature was the
`
`fracture of nitinol files within the root canal during use. See, e.g., Alapati et al., SEM
`
`observations of nickel-titanium rotary endodontic instruments that fractured during clinical use,
`
`J. Endod. 2005, 31(1), 40-43; Parashos et al., Rotary NiTi instrument fracture and its
`
`consequences, J. Endod. 2006, 32(11), 1031-1043. Broken file fragments can be difficult to
`
`retrieve. Id. at 1031. The ‘341 and ‘773 patents provide that heat treating endodontic files after
`
`manufacturing will reduce the occurrence of fracturing.
`
`23.
`
`It is known in the art that near equi-atomic nickel-titanium alloys have different
`
`crystal structures depending on temperatures close to room temperature. These crystal structures
`
`are known as austenite and martensite, and the transition from one to the other is reversible
`
`because the transformation occurs by a shear, martensitic reaction. See, e.g., Pelton et al., Effects
`
`of thermal cycling on microstructure and properties in Nitinol, Mater. Sci. Eng. A, 2012, 532,
`
`130-138. At high temperatures, nickel-titanium alloys assume a “cubic” crystal structure
`
`(austenite). At low temperature, nickel-titanium alloys spontaneously transform to a more
`
`complicated “monoclinic” crystal structure (martensite).
`
`6
`
`
`
`24.
`
`In some compositions and heat treatments, there is an additional intermediate
`
`phase occurring between the austenite and martensite, known as the R-phase (rhombohedral).
`
`The R-phase is recognized in the art as a form of martensite. See, e.g., Otsuka et al., Science and
`
`Technology of Shape-Memory Alloys: New Developments, MRS Bulletin, Feb. 2002, 91-100, 95
`
`(explaining that R-phase is one of three forms of martensitic nickel titanium alloy). Thus, when
`
`nickel-titanium alloys are in the R-phase the material is “martensitic.”
`
`25.
`
`The thermal energy absorbed or given off during the transformation between
`
`austenite (cubic), the intermediate R-phase (rhombohedral), and martensite (monoclinic) crystal
`
`structures can be measured using DSC. It is established in the scientific literature that thermal
`
`analysis by DSC is a scientifically accurate and reliable tool for determining the transformation
`
`temperatures in nickel titanium alloys.
`
`26.
`
`Upon heating from below room temperature, the crystal structure of nitinol
`
`transforms from martensite to austenite, meaning that the alloy progresses from about 0%
`
`austenite and 100% martensite to about 100% austenite and 0% martensite. The end of the
`
`transition—the point at which the material reaches about 100% austenite—is the austenite finish
`
`temperature (Af). For nickel titanium alloys, the important data points on a DSC curve during the
`
`heating cycle are the austenite start temperature (As) and the austenite finish temperature (Af).
`
`Depending on the composition and prior thermal or mechanical treatment, the austenite finish
`
`temperature can be between 0-60 ºC. Similarly, the important data points during the cooling
`
`cycle are the martensite start temperature (Ms) and the martensitic finish temperature (Mf).
`
`Additional DSC data points, known as the R-phase start temperature (Rs) and the R-phase finish
`
`temperature (Rf) may exist in both heating and cooling cycles if the alloy transitions through the
`
`intermediate R-phase.
`
`7
`
`
`
`27.
`
`The applicable ASTM Standard, ASTF2004 -05(2010) Standard Test Method for
`
`Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis (“ASTM
`
`Standard”), explains how to determine the data points of the DSC curve (i.e., As, Af, Ms, Mf). In
`
`particular, Section 11.2 of the ASTM Standard states: “Draw the tangents to the cooling and
`
`heating spikes through the infliction points as shown in Fig. 1.” Section 11.3 states: “Obtain Ms,
`
`Mf, As, and Af as the graphical intersection of the baseline with the extension of the line of
`
`maximum inclination of the appropriate peak of the curve as shown in Fig. 1.” Figure 1 is
`
`provided below.
`
`
`
`28.
`
`Consistent with the ASTM Standard, researchers generally report DSC data points
`
`in the manner described above. See, e.g., Brantley and Alapati, Heat Treatment of Dental Alloys:
`
`A Review, Chapter 1, 2012, at 10 (“The austenite-finish (Af) temperature for completion of the
`
`transformation from martensite to austenite on heating is determined by the intersection with the
`
`adjacent baseline of a tangent line to the peak for the final transformation to austenite.”)
`
`(Available at http:/dx.doi.org/10.577252398).
`
`8
`
`
`
`29.
`
`The austenite finish temperature for a nickel titanium file having superelastic
`
`properties, which has not been heat treated, is approximately 25 ºC. See, e.g., Brantley et al., J.
`
`Endo. 2002, 28(8), 567-572 at 572. However, for nitinol files of the right composition that have
`
`undergone some specific heat treatment, the austenite finish temperature can be between 35-60
`
`ºC. Brantley et al., Heat Treatment of Dental Alloys: A Review, 2012, InTech Chapter 1.
`
`30.
`
`Traditionally, endodontic files have been prepared using near equi-atomic
`
`amounts of nickel and titanium (about 55% by weight of nickel and 45% by weight of titanium),
`
`taking advantage of the composition’s superelastic properties. See, e.g., Brantley et al., J. Endo.
`
`2002, 28(8), 567-572 at 567. Studies on heat treating nitinol alloys have demonstrated that the
`
`useful range for heat treatment is between 350-600 ºC. See, e.g., M.H. Wu, Fabrication of
`
`Nitinol Materials and Components, Proceedings of the Int’l Conference on Shape Memory and
`
`Superelastic Technologies, Kunming, China, 2001, 285-292; Frick et al., Thermal Processing of
`
`Polycrystalline NiTi Shape Memory Alloys, Mater. Res. Soc. Symp. Proc. 2004, Vol. 855E,
`
`W1.9.1-W.1.9.6.
`
`31.
`
`Nitinol materials are typically heat treated in the vicinity of 500 ºC. Wu, supra at
`
`285-292. When heat treatment is performed over 600 ºC, homogenization of the nitinol occurs
`
`with properties reverting to its natural state (i.e., having the As and Af temperatures as they
`
`existed prior to heat treatment). Nickel-titanium wires and files that have not been heat treated
`
`have different thermal characteristics (e.g., the ability to absorb and/or give off heat energy) from
`
`those of wires and files that have been heat-treated. Additionally, the temperature of the phase
`
`transformations from austenite to martensite or vice versa generally is determined by the
`
`temperature range to which the files were likely heated.
`
`
`
`9
`
`
`
`B.
`
`32.
`
`The ‘773 Patent
`
`I understand that Plaintiffs have asserted both the ‘341 and ‘773 patents, however,
`
`for purposes of this report, I have been asked to focus my analysis on claim 1 of the ‘773 patent.
`
`That said, the same analysis may apply to claims in the ‘341 patent. I reserve the right to address
`
`additional claims in the future if necessary.
`
`33.
`
`I have been informed that the ‘773 patent issued from patent application Serial
`
`No. 13/455,841, filed April 25, 2012; which is a continuation of 13/336,579, filed on
`
`December 23, 2011; which was a continuation of application Serial No. 12/977,625, filed on
`
`December 23, 2010; which is a division of application Serial No. 11/628,933, filed on
`
`December 7, 2006; which is a national stage application of PCT/US05/19947, filed June 7, 2005;
`
`which claims benefit of application Serial No. 60/578,091, filed June 8, 2004.
`
`34.
`
`The ‘773 patent claims a process that requires two steps and includes a wherein
`
`clause that links a distinguishing mechanical property to the second step.
`
`35.
`
`The first step in the ‘773 patent is: “(a) providing an elongate shank having a
`
`cutting edge extending from the distal end of the shank along an axial length of the shank, the
`
`shank comprising a superelastic nickel titanium alloy.”
`
`36.
`
`The second step in the ‘773 patent is a post-manufacturing/machining heat-
`
`treatment step. It recites: “(b) after step (a), heat-treating the entire shank at a temperature from
`
`400º C up to but not equal to the melting point1 of the superelastic nickel titanium alloy.”
`
`
`1 The temperature range of “from 400º C up to but not equal to the melting point” includes
`500 ºC, which I understand is the temperature used by US Endo for heat treating at least its X1,
`X5 and X7 EdgeFiles based on US Endo’s response to Plaintiffs’ Interrogatory No. 1.
`
`10
`
`
`
`37.
`
`The property imputed to the instrument as a result of step (b) in the ‘773 patent is:
`
`“wherein the heat-treated shank has an angle greater than 10 degrees of permanent deformation
`
`after torque at 45º flexion when tested in accordance with ISO Standard 3630-1.”
`
`C.
`
`38.
`
`Independent Testing of the EdgeFiles
`
`I have reviewed and am familiar with the results of the thermal testing (DSC)
`
`conducted on each of the EdgeFiles by Veritas.
`
`39.
`
`Samples of EdgeFiles were provided to Veritas as unopened packages of 3 or 6
`
`files in the form in which they are commercially available. Prior to testing, each file was cut
`
`from the tip of the EdgeFiles for each specimen into small segments using a diamond saw.
`
`Segments of sample material of approximately 5 mm were found to weigh between 5-15
`
`milligrams.
`
`40.
`
`The DSC testing performed by Veritas utilized a PerkinElmer DSC6000 with an
`
`Intracooler 2 instrument. The instrument was calibrated to the manufacturer’s specifications
`
`using indium and zinc standard supplied by the manufacturer. Each sample was placed in the
`
`DSC instrument, and that the instrument was cooled to -65 ºC for 1 minute before increasing the
`
`temperature at 10 ºC per minute until reaching 100 ºC. Samples of each EdgeFile type (X1, X3,
`
`X5, X7, and XR) were tested in triplicate.
`
`41.
`
`The DSC curves showing the results of the thermal analysis of the EdgeFiles were
`
`provided. The table below provides a key to the samples tested and the results. The procedure in
`
`the ASTM standard was utilized to calculate the As, Af, Ms, and Mf data points.
`
`11
`
`
`
`Product
`
`Size Length
`
`
`
`
`
`
`
`EdgeFile X1 25.06 25 mm
`
`
`
`
`
`
`
`
`
`
`
`
`
`EdgeFile X3
`
`N2
`
`25 mm
`
`
`
`
`
`
`
`
`
`
`
`
`
`R-Phase
`start
`temp
`(Rs)
`
`martensite
`start temp
`(Ms)
`
`R-Phase
`finish
`temp
`(Rf)3
`
`martensite
`finish
`temp (Mf)4
`
`28 °C
`
`28 °C
`
`27 °C
`
`29 °C
`
`29 °C
`
`28 °C
`
`28 °C
`
`-17 °C
`
`-18 °C
`
`-18 °C
`
`-37 °C
`
`-37 °C
`
`-38 °C
`
`-20 °C
`
`-19 °C
`
`21 °C
`
`22 °C
`
`21 °C
`
`21 °C
`
`19 °C
`
`20 °C
`
`22 °C
`
`22 °C
`
`-35 °C
`
`-36 °C
`
`-36 °C
`
`-51 °C
`
`-58 °C
`
`-51 °C
`
`-39 °C
`
`-39 °C
`
`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
`
`EdgeFile X5 40.04 25 mm
`
`
`
`
`
`
`
`
`
`
`
`
`
`EdgeFile X7 35.06 25 mm
`
`
`
`
`
`
`
`
`
`
`
`
`
`EdgeFile XR
`
`R4
`
`23 mm
`
`
`
`
`
`
`
`
`
`27 °C
`
`27 °C
`
`29 °C
`
`28 °C
`
`29 °C
`
`
`
`
`
`
`
`-19 °C
`
`-19 °C
`
`-19 °C
`
`-20 °C
`
`3 °C
`
`0 °C
`
`1 °C
`
`22 °C
`
`23 °C
`
`22 °C
`
`22 °C
`
`
`
`
`
`
`
`-38 °C
`
`-37 °C
`
`-37 °C
`
`-36 °C
`
`-38 °C
`
`-45 °C
`
`-42 °C
`
`42.
`
`Veritas also provided a supplemental analysis in which one DCS curve from each
`
`file tested was reproduced with the austenite finish temperature determination included. The
`
`
`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.
`
`12
`
`
`
`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.
`
`Product
`
`Size
`
`Length
`
`Lot
`
`EdgeFile X1
`
`25.06
`
`EdgeFile X3
`
`N2
`
`EdgeFile X5
`
`EdgeFile X7
`
`40.04
`
`35.06
`
`EdgeFile XR
`
`R4
`
`
`
`25 mm
`
`25 mm
`
`25 mm
`
`25 mm
`
`23 mm
`
`22714011
`
`20614010
`
`81913031
`
`31014023
`
`22714092
`
`DSC Curve
`22714011
`Sample 1
`20614010
`Sample 3
`81913031
`Sample 2
`31014023
`Sample 3
`22714092
`Sample 1
`
`Austenite
`finish temp
`(Af)
`
`39 °C
`
`35 °C
`
`37 °C
`
`41 °C
`
`4 °C
`
`43.
`
`I have reviewed and am familiar with mechanical testing conducted on each of the
`
`EdgeFiles by Knight Mechanical. A report on the mechanical bend testing performed by Knight
`
`Mechanical in accordance with ISO Standard 3630-1 was provided. Samples of the EdgeFiles
`
`were provided to Knight Mechanical as unopened packages of 3 or 6 files in the form in which
`
`they are commercially available.
`
`44.
`
`A device was assembled in accordance with ISO Standard 3630-1 and a stiffness
`
`test was conducted in accordance with Section 7.5. After the stiffness test was completed, the
`
`files were measured for any angle of permanent deformation. The table below provides a key to
`
`the samples tested and the results.
`
`Size Length Sample
`Product
`
`
`X1_S1
`
`EdgeFile X1 25.06
`25 mm X1_S2
`
`
`
`X1_S3
`
`
`
`X3_S1
`EdgeFile X3 N2
`25 mm X3_S2
`
`Torque at 45°
`Angular
`Displacement
`(mN·m)
`3.60
`3.53
`3.35
`0.93
`0.91
`
`13
`
`Post-testing Permanent
`Deformation Angle
`(degrees)
`23.75
`27.00
`27.33
`1.83
`3.58
`
`
`
`
`
`
`
`EdgeFile X5 40.04
`
`
`
`
`EdgeFile X7 35.06
`
`
`
`
`EdgeFile XR R4
`
`
`
`
`X3_S3
`
`X5_S1
`
`25 mm X5_S2
`
`X5_S3
`
`X7_S1
`25 mm X7_S2
`
`X7_S3
`
`XR_S1
`23 mm XR_S2
`
`XR_S3
`
`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.
`
`45.
`
`Defendant US Endo’s Heat Treatment Process
`
`In his August 1, 2014 declaration, Mr. Bobby Bennett states that US Endo
`
`receives fluted, nickel titanium endodontic files from a third-party supplier, and then heat-treats
`
`the files in an industrial oven for the manufacture of EdgeFiles X1, X35, X5, and X7. (Bennett
`
`Declaration signed August 1, 2014 at ¶¶ 7, 8, 12, 13).
`
`46.
`
`Documents produced by US Endo outline the processing steps for the heat
`
`treatment of the EdgeFiles in more detail. First, the oven is warmed to a “proprietary
`
`temperature.” See, e.g., USENDO0000006 (Sequence # 4); USENDO0000011 (Sequence # 7).
`
`Next, the files are loaded into a metal tubes (USENDO0000006 (Sequence # 5)), and the tubes
`
`are loaded into the oven. USENDO0000007 (Sequence # 6). The oven door is shut and the tubes
`
`containing the entire files are heated for a period of time, which is recorded on a corresponding
`
`product router document. USENDO0000007 (Sequence # 7-9). The date, tube number, and time
`
`log for each heat treatment is recorded in the US Endo Heat Treat Log. See USENDO0000129-
`
`USENDO0000179. The quantities of files that are heat-treated, as well as the time of the day in
`
`which the tubes containing the files are loaded into and taken out of the oven, are recorded on
`
`US Endo Product Router documents. See, e.g., USENDO0000201.
`
`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.
`
`14
`
`
`
`47.
`
` Documents produced by US Endo show that the period of time used for the heat-
`
`treatment process can be 1, 2 or 4 hours. See, e.g., USENDO 0000129-USENDO0000179 (a
`
`“Heat Treat Log” showing various durations for the heat treatment including 2 hours).
`
`48.
`
`I understand that Mr. Bennett’s August 1, 2014 declaration states that the
`
`“EdgeFilesTM X1, X3, X5, X7 and XR are sold in several different blade diameters, lengths and
`
`degrees of taper.” Mr. Bennett’s Declaration further states that “the nickel titanium blades of the
`
`EdgeFilesTM X1, X5, X7 files are heat-treated,” and that “[e]xcept for one X3 file size (having 12
`
`degrees of taper), the nickel titanium blades of the X3 files are heat treated.”
`
`49.
`
`I understand that Plaintiffs requested the temperature used in the heat treatment
`
`referenced in Mr. Bennett’s August 1, 2014 declaration in Plaintiffs’ Interrogatory No. 1.
`
`Specifically, in Interrogatory No. 1, Plaintiffs requested that US Endo identify the specific
`
`temperature(s) used by US Endo to heat-treat the nickel titanium blades of each of the X1, X3,
`
`X5, and X7 EdgeFiles referenced in Mr. Bennett’s declaration.
`
`50.
`
`I understand that US Endo responded to Interrogatory No. 1 on September 10,
`
`2014. In response to Plaintiffs’ Interrogatory No. 1, US Endo stated, in pertinent part, that “it
`
`heat-treats the nickel titanium blades of each of the X1, X5, and X7 EdgeFiles referenced in
`
`Mr. Bennett’s declaration at a temperature of approximately 932 degrees Fahrenheit.” That
`
`temperature corresponds to 500 degrees Celsius. Thus, my understanding is that Defendant has
`
`confirmed that it heat treats the blades (i.e., shanks) of its X1, X5 and X7 EdgeFiles at a
`
`temperature recited in the claims of the ‘773 patent.
`
`
`
`15
`
`
`
`E.
`
`Comparison of the EdgeFiles with Claim 1 of the ‘773 Patent
`
`Step 1: “providing”
`
`51.
`
`According to the declaration of Mr. Bobby Bennett of August 1, 2014, EdgeFiles
`
`X1, X5, and X7 are fluted, nickel titanium files that are heat-treated, whereas EdgeFile XR is a
`
`fluted, nickel-titanium file that is not treat-treated.
`
`52.
`
`As shown by the mechanical bend testing results, the EdgeFile XR does not
`
`demonstrate permanent deformation when subjected to the testing in standard ISO 3630-1. See
`
`supra at 54. In other words, when a bending force is applied to EdgeFile XR and subsequently
`
`released, the file will spring back straight rather than remain permanently deformed. Thus, the
`
`EdgeFile XR is superelastic. It follows that EdgeFiles X1, X5, and X7—which are fluted, nickel
`
`titanium files when received by US Endo—are also superelastic.
`
`53.
`
`Accordingly, it follows that US Endo’s process for manufacturing the EdgeFiles,
`
`or at least the EdgeFiles X1, X5, and X7, includes the first step in the ‘773 patent: “(a) providing
`
`an elongate shank having a cutting edge extending from a distal end of the shank along an axial
`
`length of the shank, comprising a superelastic nickel titanium alloy.” In other words, before heat
`
`treatment, the EdgeFiles have a cutting edge and comprise a superelastic nickel titanium alloy.
`
`Step 2: “heat-treating”
`
`54.
`
`The product packaging for Edge Endo’s EdgeFiles X1, X5 and X7 indicate that
`
`the products are “HEAT TREATED NiTi FILES.”
`
`55.
`
`The August 1, 2014 declaration submitted by Mr. Bobby Bennett states that the
`
`EdgeFiles are prepared by heat-treating nickel titanium files.
`
`56.
`
`The procedure outlined in the US Endo documents call for the following steps:
`
`load the files into tubes; load the tubes into the oven; and close the oven door. See
`
`16
`
`
`
`USENDO0000006 and USENDO0000007. Therefore, the entire file is heat-treated, according to
`
`step (b) of the ‘773 patent: “after step (a), heat-treating the entire shank.”
`
`57.
`
`The documents and Interrogatory response provided by US Endo confirm that the
`
`X1, X5 and X7 EdgeFiles are heat treated at a temperature of “932 degrees F.” In Celsius, that
`
`temperature is 500 degrees.
`
`58.
`
`Therefore, it is my opinion that US Endo performs the process according to
`
`step (b) in claim 1 of the ‘773 patent, which recites: “(b) after step (a), heat-treating the entire
`
`shank at a temperature from 400º C up to but not equal to the melting point of the superelastic
`
`nickel titanium alloy.”
`
`59.
`
`This information is consistent with my earlier opinions prior to discovery, which
`
`were based only on the independent testing conducted by Veritas and Knight Mechanical, which
`
`utilized DSC for thermal analysis and bend testing for measuring permanent deformation.
`
`60.
`
`It is established in the scientific literature that thermal analysis by DSC is a
`
`scientifically accurate and reliable tool for determining the transformation temperatures in
`
`nitinol. The thermal energy absorbed or given off during the transformation between austenite
`
`(cubic), the intermediate R-phase (rhombohedral), and/or martensite (monoclinic) crystal
`
`structures can be measured using DSC. Nickel-titanium wires and files that have not been heat
`
`treated have different thermal characteristics (e.g., the ability to absorb and/or give off heat
`
`energy) from those of wires and files that have been heat treated.
`
`61.
`
`Based on the results of the DSC testing, the austenite finish temperature (Af) for
`
`the EdgeFile X1 is approximately 39 ºC; the Af for the EdgeFile X3 is approximately 35 ºC; the
`
`Af for the EdgeFile X5 is approximately 37 ºC; and the Af for the EdgeFile X7 is approximately
`
`17
`
`
`
`41 ºC. These Af results are distinguishable from the EdgeFile XR, which is not marketed as
`
`being heat treated, having an Af of approximately 3 ºC.
`
`62.
`
`As explained in the background section above, a low austenite finish temperature
`
`is indicative that the material is in its austenite form at room temperature and that it has likely not
`
`been heat treated, whereas a high austenite finish temperature (that is, greater than 25°C (room
`
`temperature)) is indicative that the material is in its martensite form at room temperature and that
`
`it has likely been heat treated. Accordingly, the testing results indicate that the EdgeFiles X1,
`
`X5, and X7 are in their martensite state at room temperature and the EdgeFile XR is in its
`
`austenite state at room temperature.
`
`63.
`
`Based on the testing results and a review of the relevant literature, it was my
`
`opinion that the Edge Endo EdgeFiles X1, X5, and X7 have been manufactured by a process that
`
`likely includes the step of heat treating the device at a temperature between 350 ºC and 600 ºC.
`
`The additional information provided by US Endo concerning the manufacturing process and
`
`temperature used has confirmed my earlier analysis and opinion, and demonstrates that US Endo
`
`uses a temperature of approximately 932 ºF, which corresponds to 500 ºC. Thus, it is my opinion
`
`that US Endo practices this claim element.
`
`Step 3 (Wherein Clause): “deformation properties”
`
`64.
`
`The claims of the ‘773 patent specifically require the use of International Standard
`
`ISO 3630-1 Dentistry – Root-canal instruments – Part 1: General requirements and test
`
`methods, was used for mechanical testing. According to this protocol, the permanent deflection
`
`angle for an endodontic file can be measured after bending the file at a 45 degree angle.
`
`65.
`
`This testing is helpful because a superelastic nickel titanium file that has not been
`
`heat treated will return to its original, straight alignment after bending at a 45 degree angle and
`
`18
`
`
`
`releasing the stress. On the other hand, a post-machining, nicke