UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`v.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`
`Case IPR2015-00632
`Patent 8, 727,773 B2
`
`DECLARATION OF ROBERT SINCLAIR, PH.D.
`
`1
`
`GOLD STANDARD EXHIBIT 2026
`US ENDODONTICS v. GOLD STANDARD
`CASE IPR2015-00632
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`v.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`
`Case IPR2015-00632
`Patent 8, 727,773 B2
`
`DECLARATION OF ROBERT SINCLAIR, PH.D.
`
`1
`
`GOLD STANDARD EXHIBIT 2026
`US ENDODONTICS v. GOLD STANDARD
`CASE IPR2015-00632
`
`
`
`I, Robert Sinclair, Ph.D., hereby declare and state that:
`
`1.
`
`I make the following declaration based on my knowledge and belief.
`
`Education and Professional Background
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`2.
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`I received a B.A. in Materials Science in 1968 and a Ph.D. in Materials
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`Science in 1972, both from Cambridge University. After receiving my Ph.D., I
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`worked from 1973-1977 as a Postdoctoral Research Engineer at the University of
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`California, Berkeley.
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`3.
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`Since 1977, I have been employed at Stanford University in Stanford,
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`California, where I have successively served as Assistant Professor in Materials
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`Science and Engineering (1977-1980), Associate Professor with tenure in
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`Materials Science and Engineering (1980-1984) and Professor of Materials Science
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`and Engineering (1984 to Present). In 2009, I was appointed the Charles M. Pigott
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`Professor in the School of Engineering at Stanford University.
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`4.
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`From 2004-2014, I served as the chair of the Materials Science and
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`Engineering Department at Stanford University. From 2002 to 2013, I was the
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`Director of the Stanford Nanocharacterization Laboratory, and from 2010-2012, I
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`was the Director of the Bing Overseas Studies Program at Stanford University. I
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`have had a number of appointments as a Visiting Professor at institutions around
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`the world, including the HREM Laboratory at Cambridge University in the United
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`Kingdom and Matsushita Electric Industrial Company in Japan.
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`2
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`5.
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`I have authored more than 240 scientific research papers, published over
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`200 articles at national and international scientific meetings, and made over 500
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`presentations at conferences, university departments, and research laboratories
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`world-wide. My publications, which are listed on my curriculum vitae attached
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`hereto as Exhibit A, are in the areas of materials science, and include investigations
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`on the properties of nickel-titanium alloys. I have also authored and/or edited
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`several books and book chapters, and I hold two patents.
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`6.
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`I have served as a member on the Editorial Board for the Journal of
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`Applied Physics (1994-1996) and the Journal of Electron Microscopy (1996-
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`present), among other journals. I routinely review articles for scholarly journals.
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`7.
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`I have taught more than 6,000 students in undergraduate and graduate
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`courses, including, among others, Introduction to Materials Science; Imperfections
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`in Crystalline Solids; Atomic Arrangements in Solids; Nanostructure and
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`Characterization; X-ray Diffraction Laboratory; Nano-Characterization of
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`Materials; Transmission Electron Microscopy; and Microscopic World of
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`Technology.
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`8. My current research interests are in the structure-property-processing
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`correlations in materials, using high-resolution microscopy and diffraction
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`techniques, application to development of integrated circuit and magnetic
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`recording materials and introduction of in situ high resolution electron microscopy.
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`3
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`This includes their application to understanding phase transformations and
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`deformation of nitinol alloys, correlated with Differential Scanning Calorimetry
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`(DSC) analysis.
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`9.
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`Throughout the course of my career, I have received various honors and
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`awards, as described in detail in my curriculum vitae. Some of the awards I have
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`received include the Robert Lansing Hardy Gold Metal from the Metallurgical
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`Society of AIME in 1976, the Alfred P. Sloan Foundation Fellowship in 1979, the
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`Distinguished Scientist Award (Physical Sciences) from the Microscopy Society of
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`America in 2009, and the David M. Turnbull Lectureship Award from the
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`Materials Research Society in 2012.
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`10. Based on my experience and qualifications, I am qualified to render
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`opinions in the field of nickel-titanium alloys. I am an expert in the field of
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`materials science and engineering, particularly in electron microscopy and material
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`structure and phase transformations, with several well-cited articles on the
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`behavior of nitinol alloys.
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`My understanding of the Proceeding
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`11.
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`I have been retained in this matter by Rothwell, Figg, Ernst & Manbeck,
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`P.C. of Washington, D.C., the attorneys representing the Patent Owner in this
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`proceeding. I am being compensated at my regular consulting rate of $600 per
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`hour for time spent consulting, plus expenses.
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`4
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`12.
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`I understand that the real parties in interest for the Patent Owner are Gold
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`Standard Instruments, LLC; Dentsply International Inc.; and Tulsa Dental Products
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`LLC d/b/a Tulsa Dental Specialties.
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`13.
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`I do not have a financial interest in any of the real parties in interest or in
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`the outcome of this proceeding.
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`14. My opinions provided in this declaration are as an independent expert
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`witness.
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`15. Prior to my involvement in this matter, my previous personal contact
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`with the real parties in interest was as an independent expert witness for related
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`litigation in federal district court. That litigation is styled under the caption
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`Dentsply International, Inc. and Tulsa Dental Products LLC d/b/a Tulsa Dental
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`Specialties v. US Endodontics, LLC, Case No. 2:14-cv-00196-JRG (E.D. Tenn.).
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`16.
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`I am informed that an inter partes review proceeding involving claims 1-
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`17 of U.S. Patent No. 8,727,773 B2 (the “’773 patent”) has been instituted by the
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`Patent Trial and Appeal Board at the United States Patent and Trademark Office.
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`17.
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`I am informed that the ’773 patent issued from U.S. patent application
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`serial no. 13/455,841, filed Apr. 24, 2012, which is a continuation of application
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`serial no. 13/336,579, filed Dec. 23, 2011, which is a continuation of application
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`serial no. 12/977,625, filed Dec. 23, 2010, which is a division of application serial
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`no. 11/628,933, filed Dec. 7, 2006, which is a national stage entry of international
`
`
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`5
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`
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`application no. PCT/US05/19947, filed Jun. 7, 2005, which claims benefit of
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`application serial no.60/578,091, filed Jun. 8, 2004.
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`18.
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`In forming my opinions set forth in this declaration, I relied on my
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`experience, education, knowledge, and the materials discussed or cited in my
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`declaration.
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`My understanding of the legal standards
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`19.
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`I have been informed that for a prior art reference to anticipate a patent
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`claim, the reference must disclose all of the limitations, either expressly or
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`inherently, arranged in the same way as in the claim. I have been informed that
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`express anticipation means that each and every limitation of a claim is expressly
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`disclosed in the prior art reference. I have also been informed that inherent
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`anticipation requires that a person of ordinary skill in the art would recognize that a
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`missing descriptive feature of the claim is necessarily present in the prior art
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`reference.
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`20.
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`I have been informed that a determination of obviousness requires
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`consideration of: (1) the scope and content of the prior art; (2) the differences
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`between the prior art and the claims at issue; (3) the level of ordinary skill in the
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`art; and (4) objective evidence of nonobviousness, if any.
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`21.
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`I have also been informed that when combining references in an
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`obviousness analysis it is important to identify a reason and rationale that would
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`6
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`have prompted a person of ordinary skill in the art to combine the teachings of
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`different prior art references to achieve the claimed invention. I have been
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`informed that obviousness cannot be based on the hindsight selection of elements
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`of the claimed invention from among the disclosures of prior art references. I have
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`also been informed that a prior art must be considered as a whole, including
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`portions that would teach away from the claimed invention. I have been informed
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`that a reference may teach away from a particular combination when the prior art
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`reference criticizes, discredits, or disparages such a combination, or otherwise
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`suggests taking a path that is divergent from that path leading to the claimed
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`invention. I understand that it is improper to pick and choose from different
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`portions of references.
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`22.
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`I understand that certain determinations are to be analyzed from the
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`perspective of a “person having ordinary skill in the art,” and that such a person
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`would be involved with the technology at issue at the time of the claimed
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`invention. Based on my review of the ’773 patent, my review of the materials
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`relied on in the petition for inter partes review, and my own research and academic
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`experience, I believe that a person of ordinary skill in the art would have had
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`familiarity with nickel titanium alloys and would likely have at least a B.S. degree
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`in material science, metallurgy, or related field and several years of experience in
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`metallurgy and nickel titanium alloys in particular. Alternatively, a person of
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`
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`7
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`
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`ordinary skill in the art could have a higher level of education and less experience
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`or vice-versa. The relevant experience could be in industry, academia, government,
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`private practice, a clinic or any other setting so as to provide an understanding of
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`the structural or mechanical properties of nickel titanium endodontic instruments.
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`23.
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`In forming my opinions I considered the level of skill for a person of
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`ordinary skill in the art and the scope and content of the prior art in the time period
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`of around June 8, 2004, the claimed priority date of the ’773 patent.
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`Background relating to nickel-titanium files
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`24. Special properties of nickel titanium alloys containing an approximately
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`50:50 atomic ratio of nickel to titanium (known as “nitinol”) were first discovered
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`at the Naval Ordnance Laboratory in 1959. Those properties are known as
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`superelasticity and shape memory. Almost thirty years passed before reports of
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`using nitinol in endodontic hand files appeared. See, e.g., Walia et al., An initial
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`investigation of the bending and torsional properties of Nitinol root canal files. J.
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`Endod. 1988, 14, 346-351 (Ex. 1003).
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`25. Near equi-atomic nickel-titanium alloys have different crystal structures
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`depending on temperature. At high temperatures, nickel-titanium alloys assume a
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`“cubic” crystal structure (austenite). At low temperature, nickel-titanium alloys
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`spontaneously transform to a more complicated “monoclinic” crystal structure
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`(martensite). A “rhombohedral” crystal structure is sometimes observed between
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`
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`8
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`
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`the austenitic and martensitic phases in some nickel-titanium compositions (R-
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`phase). The reversible transition from austenite to martensite occurs through a
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`shear, martensitic reaction. The martensitic transformation may be temperature-
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`induced or stress-induced.
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`26. The thermal energy absorbed or given off during the transformation
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`between austenite (cubic), the intermediate R-phase (rhombohedral), and
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`martensite (monoclinic) crystal structures can be measured using differential
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`scanning calorimetry (DSC). It is established in the scientific literature that
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`thermal analysis by DSC is a scientifically accurate and reliable tool for
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`determining the transformation temperatures in nickel titanium alloys.
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`27. Upon heating from a very low temperature, the crystal structure of nickel
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`titanium transforms from martensite to austenite, meaning that the alloy progresses
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`from about 0% austenite and 100% martensite to about 100% austenite and 0%
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`martensite. The end of the transition—the point at which the material reaches
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`about 100% austenite—is the austenite finish temperature (Af). For nickel titanium
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`alloys, the important data points on a DSC curve during the heating cycle are the
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`austenite start temperature (As) and the austenite finish temperature (Af). Upon
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`cooling from a high temperature, the crystal structure of nickel titanium transforms
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`from austenite to martensite, and the important DSC data points are the martensite
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`start temperature (Ms) and the martensitic finish temperature (Mf). Additional
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`9
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`
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`DSC data points, known as the R-phase start temperature (Rs) and the R-phase
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`finish temperature (Rf) may be observed during the heating and/or cooling cycles if
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`the alloy transitions through the intermediate R-phase.
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`28. The applicable ASTM Standard, F2004 -05 (2010) Standard Test Method
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`for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
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`(“ASTM Standard”) (Ex. 2032), explains how to perform a DSC test, determine
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`the data points of the DSC curve (i.e., As, Af, Ms, Mf), and interpret the data. To
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`determine the data points, section 11.2 states: “Draw the tangents to the cooling
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`and heating spikes through the inflection points as shown in Fig. 1.” Ex. 2032 at 2.
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`Section 11.3 states: “Obtain Ms, Mf, As, and Af as the graphical intersection of the
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`baseline with the extension of the line of maximum inclination of the appropriate
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`peak of the curve as shown in Fig. 1.” Id. Figure 1 is below.
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`
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`10
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`
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`Thus, per the ASTM, Ms and Mf are obtained from the cooling curve (top curve in
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`the above figure) and As and Af are obtained from the heating curve (bottom curve
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`in the above figure). The Rs and Rf temperatures, when present, are typically
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`obtained in the same manner.
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`29. Superelastic nickel-titanium endodontic rotary files were well-known and
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`popular files prior to the invention of the ’773 patent. Ex. 2028, ¶¶ 22-32;
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`Ex. 1002, ¶ 25. The applicable international standard was ISO 3630-1, entitled
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`Dental Root-Canal Instruments—Part 1: Files, reamers, barbed broaches, rasps,
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`paste carriers, explorers and cotton broaches (“ISO 3630”).1 Ex. 1016. This first
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`edition of the international standard was published in 1992 before nickel-titanium
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`endodontic files were common and thus only discusses stainless steel endodontic
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`files. Id. at 2 (section 4.1.1). ISO 3630 includes information and requirements
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`related to the sizes, materials, and dimensions of endodontic instruments. Ex. 1016
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`at 1-11. It also includes testing specifications. Id. at 12-15.
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`30. The bending test is in section 6.4. Id. at 13-14. The test requires the
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`removal of the handle at the point where the handle is attached to the instrument
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`shaft. Id. at 13. The tip of the test piece (file) is then set 3 mm into a chuck on a
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`torque-measuring device such that the test piece is perpendicular to the axis of the
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`1 ISO (the International Organization for Standardization) is a worldwide
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`federation of national standards bodies. Ex. 1017 at iv.
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`
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`11
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`
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`motor. Id. The testing apparatus is set to stop the angular deflection at 45°. Id. A
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`catch pin is mounted on the motor shaft of the device, and upon activation of the
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`device, the catch pin will press against the shaft end of the instrument to bend the
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`test piece (file) until it reaches an angular deflection of 45°. Id. The force is then
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`recorded. Id.
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`31. One may measure the degree of permanent deformation; i.e., the
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`permanent deformation resulting from the ISO 3630 bend test. Some devices
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`allow one to measure the permanent deformation angle directly from the testing
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`apparatus. Ex. 2029 at 240. Alternatively, a calibrated protractor can be used to
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`determine the degree of permanent deformation after testing in accordance with the
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`ISO 3630 bend test. Ex. 2030 (Ex. A at 2).
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`The ’773 patent
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`32. The ’773 patent discloses an improved process for manufacturing or
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`modifying dental instruments used in performing root canal therapy on a tooth.
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`Ex. 1001 at 2:56 - 3:16.
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`33. The ’773 patent discusses problems encountered when performing a root
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`canal therapy on a curved root canal. Ex. 1001 at 2:13-23. For example, stiffer
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`files are difficult to insert through the curved portion of a canal, and in some cases
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`will cut only on the inside of the curve. Id.
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`34. The ’773 patent discusses, in one embodiment, a method of modifying
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`
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`12
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`
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`nickel titanium endodontic files by heat-treating the shank at a temperature above
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`25°C. Ex. 1001 at 4:12-25. The ’773 patent states that the heat treatment can be
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`conducted at a temperature from 400°C up to but not equal to the melting point of
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`the alloy. Id. The ’773 patent states that the heat treatment temperature can be
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`from 475-525°C or 500°C. Id. The ’773 patent states that other temperatures are
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`suitable, as they are dependent on the time period selected for heat exposure. Id.
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`35. The ’773 patent includes representative methods of modifying
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`endodontic instruments using heat treatment, and the heat-treated files maintain a
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`deformed shape after bend testing. Ex. 1001 at 8:32-59 (Example 4). Thirty files
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`for each of six different sizes were used to study the angle of permanent
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`deformation after testing in accordance with ISO 3630. The files comprised 54-57
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`weight percent nickel and 43-46 weight percent titanium. For each of the six
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`different files, ten were heat-treated at 500°C for 75 minutes (TT), ten of each kind
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`were coated with titanium nitride with inherent heat-treatment (Ti-N), and ten of
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`each kind were not heat treated (Control). The results of the bend testing are
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`shown in Figure 6. Id. Figure 6 is set out below.
`
`
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`13
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`
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`36. The ’773 patent shows that TT files maintained about 28-30 degrees of
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`permanent deformation after testing in accordance with ISO 3630. Ex. 1001,
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`Figure 6. The Ti-N coated files maintained about 15-24 degrees of permanent
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`deformation after testing in accordance with ISO 3630. Id. The unheated,
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`superelastic Control files maintained about 2-4 degrees of permanent deformation
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`after testing in accordance with ISO 3630. Id. Thus, a person of ordinary skill in
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`the art would understand that in this patent a superelastic file is meant to
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`encompass files with a de minimis amount of residual bend after the ISO 3630
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`bend test. A person of ordinary skill in the art also would understand that the
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`claimed invention requires that the heat treated instrument must have significant
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`deformation of greater than 10 degrees after the ISO 3630 bend test.
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`14
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`37.
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`I disagree with Dr. Goldberg’s statement that superelastic files must
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`recover 100% of their original shape after undergoing the bend test. This is
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`contrary to the teaching of the ’773 patent, as well as my own experience with
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`nickel titanium. During his cross examination, Dr. Goldberg stated that he was
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`applying Dr. Sinclair’s definition of superelasticity. Ex. 2034 at 20:8 - 25:8. That
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`is not true. I do not define superelasticity as requiring 100% recovery after
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`deformation.2 During my deposition, I explained multiple times that superelasticity
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`allows for some residual deformation. Ex. 2037 at 136:8 - 138:3; 143:4-14.
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`Further, when I testified in Court at the hearing regarding a preliminary injunction,
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`I made clear that my understanding of superelasticity, including how that term is
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`used in the context of the ʼ773 patent, allowed for a small amount of residual
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`deformation (i.e., up to ~3 %) after the bend test. Ex. 2001 (Second Substitute) at
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`294:22 - 297:12.
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`2 It appears that Petitioner and Dr. Goldberg are attributing this definition to me
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`because they have misinterpreted a general comment I made during my deposition
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`in the related litigation about an object recovering its complete original state
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`(Ex. 2037 at 105:23 - 106:5) and because of a similar statement in my expert report
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`indicating that a superelastic file will return to its “original straight alignment”
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`(Ex. 2038 at ¶ 65). Neither of those statements, however, was meant to exclude a
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`de minimis amount of deformation.
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`
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`15
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`
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`38.
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` It is well known in the art that superelastic materials can exhibit residual
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`plastic strain called “permanent set.” For example, Pelton Figures 4 and 5 display a
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`number of good examples of permanent set. Ex. 1006 at 111-12. Pelton even
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`refers to the “superelastic flags” and notes that “the permanent set also increases
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`with temperature.” Id. at 111.
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`39. The fact that Dr. Goldberg is taking the position that superelasticity
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`requires 100% recovery of a file’s original shape makes me doubtful of his
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`knowledge and experience in this area. I am not aware of anyone in the art
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`defining superelasticity as requiring 100% recovery after undergoing a bend test.
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`40. The ’773 patent also discusses other studies that measure torsion
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`(reported in g·cm), maximum torque at 45° of flexion (reported in g·cm), and
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`fatigue (reported in cycles to failure). Ex. 1001 at 7:18-43 (Example 1); 7:45 - 8:2
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`(Example 2); 8:61 - 9:18 (Example 5). In each study, thirty files for each of six
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`different sizes were used. The files comprised 54-57 weight percent nickel and 43-
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`46 weight percent titanium. For each of the six different files, ten were heat-
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`treated at 500°C for 75 minutes (TT), ten of each kind were coated with titanium
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`nitride with inherent heat-treatment (Ti-N), and ten of each kind were not heat
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`treated (Control). The results of the testing are shown in Figures 3-5 and 7. Id.
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`41. The ’773 patent summarizes these studies and states that the files heat-
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`treated at 500°C for 75 minutes exhibited a higher resistance to torsion breakage,
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`16
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`
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`can withstand increased strain, have higher flexibility, have increased fatigue life,
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`and maintain any acquired shape upon fracture better when compared to untreated
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`files. Ex. 1001 at 9:19-23. The ’773 patent states that the files prepared according
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`to the invention overcome the problems encountered when cleaning and enlarging
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`curved root canals during root canal therapy. Ex. 1001 at 9:23-30.
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`42. The ’773 patent claims are directed to methods for manufacturing or
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`modifying an endodontic instrument for use in performing root canal therapy on a
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`tooth. Ex. 1001 at 9:43 - 10:57. Each of the methods requires: (a) providing an
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`elongate shank having a cutting edge extending from a distal end of the shank
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`along an axial length of the shank, the shank comprising a superelastic nickel
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`titanium alloy; and (b) after step (a), heat-treating the entire shank at a temperature
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`from 400°C up to but not equal to the melting point of the superelastic nickel
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`titanium alloy, wherein the heat treated shank has an angle greater than 10 degrees
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`of permanent deformation after torque at 45 degrees of flexion when tested in
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`accordance with ISO Standard 3630.1. Id.
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`43. The ’773 patent claims, therefore, require that a superelastic nickel
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`titanium shank be heat treated over 400°C, and that the resulting shank must
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`maintain an angle greater than 10 degrees of permanent deformation after torque at
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`45 degrees of flexion when tested in accordance with ISO 3630.
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`44.
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`I disagree with Dr. Goldberg’s statement that the “wherein” clause in
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`
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`17
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`
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`the ’773 patent claims (“wherein the heat treated shank has an angle greater than
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`10 degrees of permanent deformation after torque at 45 degrees of flexion when
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`tested in accordance with ISO Standard 3630.1”) can be satisfied if the prior art
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`teaches heat-treated nickel titanium endodontic instruments that are permanently
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`deformable or have austenite finish temperatures above body temperature.
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`Ex. 1002 at 39.
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`45. First, the claims require a particular amount of permanent deformation:
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`an angle greater than 10 degrees of permanent deformation after torque at 45
`
`degrees of flexion. As noted above, a de minimis amount of permanent set is
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`observed when superelastic endodontic files are subjected to the ISO 3630 bend
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`test. Accordingly, a finding that “endodontic instruments are permanently
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`deformable” is not sufficient to satisfy the claim limitation.
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`46. Second, the claims do not refer to austenite finish temperatures. The
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`’773 patent does not mention austenite finish temperature. And, as will be further
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`explained below, the austenite finish temperature does not always correlate with
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`mechanical bending properties. Accordingly, a finding that “endodontic
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`instruments have austenite finish temperatures above body temperature” is not
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`sufficient to satisfy the claim limitation. Dr. Goldberg’s interpretation of the
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`wherein clause is not reasonable.
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`47.
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`I understand that Dr. Goldberg has considered the prosecution history of
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`18
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`
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`the ’773 patent in forming his opinions. Dr. Goldberg relies on a document
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`attached to an “Applicant Initiated Interview Request Form” that was submitted to
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`the Patent Office on July 24, 2013. Ex. 1002, ¶¶ 33-34 (citing Ex. 1008 at 144-60).
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`48.
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`I have reviewed Exhibit 1008, including the document attached to the
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`Interview Request Form. Ex. 1008 at 144-60. In my opinion, nothing in that
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`document makes Dr. Goldberg’s interpretation of the “wherein” clause reasonable.
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`The wherein clause of the ’773 patent requires that the files heated according to the
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`claimed method must have “an angle of greater than 10 degrees of permanent
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`deformation” when tested in accordance the bending test described in ISO 3630. It
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`is my understanding that Dr. Luebke was distinguishing his invention, which is a
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`method for making a deformable nickel titanium endodontic file for use in
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`performing root canal therapy, from the prior art reference, which disclosed a
`
`superelastic Nitinol wire, ribbon, sheet, or tubing. Id. at 104. As can be seen from
`
`the examiner’s summary of the interview with Dr. Luebke, the prior art conducted
`
`heat treatments for annealing and shape setting purposes to arrive at a superelastic
`
`device, whereas Dr. Luebke’s claimed invention pertained to heat treatments on a
`
`superelastic device (file) that resulted in a permanently deformable file. Id. at 163.
`
`49.
`
`I understand that Petitioner also intends to rely on statements made
`
`during the prosecution history of a related patent, U.S. Patent No. 8,876,991 (the
`
`“ʼ991 patent”), which it asserts support an interpretation that an Af above body
`
`
`
`19
`
`
`
`temperature will satisfy the claimed permanent deformation requirement. I
`
`disagree. During prosecution of the patent application, Dr. Luebke submitted a
`
`declaration in which he stated:
`
`5. The DSC of the endodontic instruments heat-treated at 375°C,
`400°C, and 500°C all showed that the endodontic instruments were in
`the martensitic phase. These DSC results are attached as Exhibits A
`and B and C. This indicates that the endodontic instruments heat
`treated at 375°C, 400°C and 500ºC will all have an angle greater than
`10 degrees of permanent deformation after torque at 45° of flexion
`when tested in accordance with ISO Standard 3630-1 as recited in
`pending independent claims 1, 6 and 11 of my patent application.
`
`Ex. 1030 at 125-132. As an initial matter, where the Af is above body temperature,
`
`it does not follow that the nickel titanium will be martensitic at room temperature.
`
`Depending on the other transition temperatures, such as As, Ms and Mf (and Rs and
`
`Rf), the nickel titanium can be biphasic. Biphasic nickel titanium can have
`
`superelastic properties. Ex. 2033 at 2:24-29. Therefore, I do not believe Dr.
`
`Luebke’s statement provides any support for asserting that a file is permanently
`
`deformable, as recited in the claims, where the Af is above body temperature.
`
`50. Additionally, without adequate testing to establish correlations for
`
`specific nickel titanium alloys, one cannot predict mechanical behavior based
`
`solely on crystal structure. Dr. Goldberg agreed to as much during his deposition
`
`in the district court litigation. Ex. 2025 at 87:3 - 88:4; 112:20 - 114:24; 123:21 -
`
`
`
`20
`
`
`
`124:14; 176:6-20. I understand Dr. Luebke has a great deal of experience testing
`
`his particular files. I also understand that he performed informal bend tests after
`
`conducting the heat treatments referred to in his declaration in Exhibit 1030.
`
`Ex. 2027 at ¶¶ 51-60. Based on his experience with prior tests (both DSC and
`
`bend tests), and his informal inspection and testing of the files, I believe he was
`
`reasonably able to predict the behavior of those files. But it is my opinion,
`
`consistent with Dr. Goldberg’s original deposition testimony in the related
`
`litigation, that one cannot make an accurate prediction regarding mechanical
`
`behavior based on DSC testing alone without such additional testing.
`
`
`
`The Kuhn reference does not anticipate the claims of the ’773 patent
`
`51. As an initial matter, I understand from reading Dr. Lemon’s declaration,
`
`that in the period of over 15 years between the publication by Walia in 1988
`
`(referenced above) and the filing of Dr. Luebke’s international patent application
`
`in 2005, nobody thought to heat treat an entire superelastic nickel titanium
`
`endodontic file in order to make a softer, permanently deformable endodontic file.
`
`Ex. 2028, ¶ 33.
`
`52.
`
`I have reviewed the Declaration of A. Jon Goldberg (Ex. 1002) that I
`
`understand to have been submitted by Petitioner US Endodontics, LLC in support
`
`of its petition for inter partes review. I understand that Dr. Goldberg offered an
`
`
`
`21
`
`
`
`opinion that Kuhn et al., 28 J. Endodontics 716 (2002) (Ex. 1019) (“Kuhn”)
`
`discloses all of the elements in claims 1, 2 and 9-12 of the ’773 patent. I disagree
`
`with Dr. Goldberg. In my opinion, Kuhn does not teach or suggest all of the
`
`elements of claims 1, 2, and 9-12 of the ’773 patent. As described in detail below,
`
`Kuhn does not teach or even suggest heat treating an endodontic file to make it
`
`permanently deformable, and certainly does not teach or suggest: (1) heat
`
`treatment of the entire shaft of an instrument; or (2) a method of heat treatment that
`
`generates files having “an angle of greater than 10 degrees of permanent
`
`deformation” when subjected to bend testing in accordance with ISO 3630.
`
`53. Kuhn states that the aim of their study was to show the fatigue
`
`characteristics of superelastic NiTi and the effect of the process history on the
`
`fracture life of endodontic files. Ex. 1019 at 716. In my opinion, one of ordinary
`
`skill in the art would understand that “process history” refers to the thermal cycling
`
`of cold working and/or annealing the nickel titanium alloy during the process of
`
`shaping an ingot into a wire, as well as changes that later occur in a file as a result
`
`of the repeated use in a clinical setting.
`
`54. Kuhn states: “In the present work, fatigue properties of NiTi engine-
`
`driven rotary files have been characterized by using differential scanning
`
`calorimetry (DSC) and mechanical testing (bending).” Ex. 1019 at 716. “The DSC
`
`technique was used to measure precise transformation. The degree of deformation
`
`
`
`22
`
`
`
`by bending was studied with combined DSC and mechanical property
`
`measurements.” Id. “DSC allows the identification of crystallographic phases at
`
`various temperatures.” Id.
`
`55. Kuhn studied instruments from Maillefer (ProFile) and Micro-Mega
`
`(Hero). Id. at 716-17. Some of the files tested by Kuhn were new, some of the
`
`files tested by Kuhn had been used in a clinical setting (described as 10-12 root
`
`canals followed by 5-6 autoclaves), and one of the files (the Profile 04./20) was
`
`subjected to a series of thermal heat treatments. The thermal treatments on the
`
`Profile 04/20 specimens “consisted of anneals at 350°C, 400°C, 450°C, 510°C,
`
`600°C, and 700°C in salt baths for 10 min and at 600°C and 700°C for 15 min with
`
`the same process and subsequent water quench in all cases.” Id.
`
`56. Kuhn states that the “[s]pecimens were cut to separate the working or
`
`active part of the file from the inactive part.” Id. at 717.
`
`57. The transformation temperatures of the files in Kuhn were measured
`
`using DSC. Id. Kuhn cut 5 mm segments from each sample and obtained DSC
`
`thermograms. Id. Kuhn used the following DSC protocol: the cut specimens were
`
`placed in a DSC testing chamber (an aluminum pan) and then put in the DSC
`
`instrument; the DSC environment was warmed to 60°C and then cooled to -120°C
`
`at a cooling rate of 5°C/minute, and then the samples were heated to 60°C using the
`
`same rate. Id. Kuhn states that the start and finish temperatures of each p
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