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 NEILL H. LUEBKE, D.D.S., M.S.
`
`GOLD STANDARD EXHIBIT 2027
`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 NEILL H. LUEBKE, D.D.S., M.S.
`
`GOLD STANDARD EXHIBIT 2027
`US ENDODONTICS v. GOLD STANDARD
`CASE IPR2015-00632
`
`
`
`
`
`I, Neill H. Luebke, D.D.S., M.S., affirm and declare as follows:
`
`A.
`
`Education and Experience
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`1.
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`I recently retired as an endodontist with Advanced Dental Specialists
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`in Waukesha, Wisconsin. I have been practicing dentistry since graduating from
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`dental school in 1969 and practicing endodontics since 1980. I became a board
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`certified endodontist on April 17, 1991. During the course of my career, I have
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`performed approximately 40,000 endodontic procedures.
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`2.
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`I attended the University of Iowa College of Dentistry, where I
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`obtained my Doctor of Dental Surgery (“DDS”) on June 6, 1969. I also completed
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`an internship at Denver General Hospital before continuing my education at the
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`University of Iowa Graduate College, where I also earned a Master of Science
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`degree on December 22, 1972. I served on the faculty at the University of Iowa for
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`eight years, where I taught classes in operative dentistry and pharmacology. I then
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`attended the University of Nebraska Medical Center, Lincoln, College of Dentistry,
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`where I earned my certificate in Endodontics on May 10, 1980. While continuing
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`in private practice, I also served as Chairman of endodontics at Marquette
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`University for four years from 1987 to 1991.
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`3.
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`I am active in professional organizations, including the American
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`Dental Association (“ADA”) and the American Association of Endodontics
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`(“AAE”). I have served on several committees, including as a consultant to the
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`2
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`
`
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`Council on Scientific Affairs for the ADA and as the sole representative to the
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`American Dental Association Subcommittee on Dental Products for the AAE. I
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`served as the U.S. expert to the International Organization for Standardization
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`(“ISO”) for Endodontic Materials and Endodontic Instruments, and I am now
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`convener for ISO TC106 SC4 WG9 for Endodontic Instruments and ISO TC106
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`SC1 WG2 Endodontic Materials. I also have Diplomate status with the American
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`Board of Endodontics.
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`4.
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`I have published articles related to the field of dentistry and
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`endodontics in several highly respected peer-reviewed journals, including the
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`Journal of Endodontics, the American Journal of Roentgenography, the Journal of
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`Prosthetic Dentistry, the Journal of Dental Education, the Journal of the American
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`Dental Association, and the Journal of Public Health Dentistry. I also serve on the
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`Scientific Advisory Board for the Journal of Endodontics.
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`5.
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`I am the inventor of five issued U.S. patents:
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`(1) United States Patent No. 8,062,033, entitled “Dental and Medical
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`Instruments Comprising Titanium,” which was filed as PCT application on June 7,
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`2005 and was filed as a national stage application in United States on December 7,
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`2006, and issued on November 22, 2011;
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`(2) United States Patent No. 8,083,873, entitled “Dental and Medical
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`Instruments Comprising Titanium,” which was filed on December 23, 2010 and
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`3
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`
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`issued on December 27, 2011;
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`
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`(3) United States Patent No. 8,562,341, entitled “Dental and Medical
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`Instruments Comprising Titanium,” which was filed on December 23, 2011 and
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`issued on October 22, 2013;
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`(4) United States Patent No. 8,727,773 (the “’773 Patent”), entitled “Dental
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`and Medical Instruments Comprising Titanium,” which was filed on April 25,
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`2012 and issued on May 20, 2014; and
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`(5) United States Patent No. 8,876,991 (the “’991 patent”), entitled “Dental
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`and Medical Instruments Comprising Titanium,” which was filed on January 29,
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`2014 and issued on November 4, 2014.
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`All five of my patents are related, and they each claim priority to the
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`provisional patent application No. 60/578,091 that I filed with the United States
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`Patent and Trademark Office on June 8, 2004.
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`6.
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`I am the President of Gold Standard Instruments, LLC (“Gold
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`Standard”), the assignee of the ’773 patent and the Patent Owner in this
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`proceeding. I submit this declaration in support of the Patent Owner’s Response to
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`the petition for inter partes review of the ’773 patent.
`
`B.
`
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`Background of the ’773 Patent
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`7.
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`Endodontics is a branch of dentistry concerned with the diagnosis and
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`treatment of diseases of the pulp—the soft, inner tissue of the tooth containing
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`4
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`
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`nerve and blood vessels within the center of a tooth. See Exhibit 1001 at col. 1, ll.
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`31-35. The graphic below depicts the general anatomy of a tooth.
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`
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`8.
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`During a root canal procedure, which is a form of endodontic therapy,
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`the root canal of the tooth is cleaned and cleared of all diseased or decayed
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`material. The canal is then shaped and is filled with an inert material such as gutta
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`percha. The filled canal is then sealed in order to preserve the tooth. The graphic
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`below generally depicts the steps of a root canal procedure.
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`5
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`
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`9.
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`Dentists or endodontists (a dentist with additional specialized
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`education and training in endodontics) use small metal instruments known as
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`endodontic files to remove the damaged pulp and shape the root canal. In some
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`cases, a single file may be used, and in other cases, the dentist or endodontist will
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`use a series of files, which may vary in diameter, shape or length during the
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`endodontic procedure. The graphic below generally depicts an endodontic file of
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`the type described in the prior art.
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`6
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`10. Prior to the 1990s, endodontic files were generally made from
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`stainless steel and were mostly manually operated hand files. In 1988, Walia et al.
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`published one of the first articles on the use of a nickel titanium (“NiTi”) alloy for
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`the fabrication of endodontic files. See Ex. 1003 at 346. Several different NiTi
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`endodontic files were commercially available only a few years later. Ex. 2029 at
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`239.
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`11. Some root canals are straight and accessed easily, particularly in the
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`teeth located in the front (or anterior) portion of the mouth. However, teeth located
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`in the back (or posterior) portion of the mouth, typically have more curved root
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`canals that are more difficult to access, clean, and obturate.
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`12. One of the challenges faced by endodontists is that the naturally
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`curved shape of the root canal makes it difficult to navigate a long, curved canal
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`with a straight endodontic file. Ex. 1001 at 1:58–2:23.
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`13. During the cleaning process, the forces exerted against the canal by
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`the file can lead to endodontic “mishaps” known as zipping, ledging and
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`transportation causing an apical perforation. The graphic below on the far left
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`generally illustrates a curved root canal. The graphics in the center and on the far
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`right illustrate the forces exerted between the curved canal and the file.
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`7
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`
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`14. Ledging is an issue similar to one observed when drilling a hole in a
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`wooden dowel. Sometimes, a drill bit does not drill a straight hole in the dowel.
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`Further attempts to correct the path by making a “new” hole in the dowel are
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`difficult because the bit will want to follow the original path. The image set out
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`below illustrates this in the context of a root canal. An endodontic file has gone to
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`the right of the hole and created a ledge. Additional attempts to clean and shape
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`the canal may result in the file getting caught in the ledge, and as a result, the file
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`may not make it through the canal to the apex of the tooth for proper obturation or
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`filling. The graphic below generally depicts ledging, which can be an obstruction
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`when filing a canal. Ex. 2005, Fig 2B.
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`
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`8
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`
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`15. Zipping of a root canal is the result of the tendency of the instrument
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`to straighten inside a curved root canal or at the apex causing a perforation. The
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`graphic below generally depicts zipping. Ex. 2005, Fig 2D and 2E (below).
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`
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`16. Transportation means that the periapex, the area around the bottom of
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`the tooth has been violated or perforated by the file. Perforations are associated
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`with destruction of the root cementum and irritation and/or infection of the
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`periodontal ligament and are difficult to seal. The graphic below generally depicts
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`transportation with a resultant perforation. Ex. 2005, Fig 2C (below).
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`17.
`
`In the early 1990s, NiTi alloys succeeded stainless steel as the
`
`material of choice for endodontic files because of their balance of flexibility and
`
`
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`9
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`
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`
`
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`strength as compared to stainless steel. That is, NiTi was sufficiently strong for use
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`as an endodontic file, while being more flexible than stainless steel, but not to the
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`point of feeling like a “wet noodle” when one attempts to negotiate sclerotic
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`canals. Ex. 1025 at 211. Endodontists also preferred the superelastic behavior of
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`NiTi, and viewed it as an improvement to stiff stainless steel files. By superelastic,
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`I mean that if the files are bent, such as in the root canal of a tooth, they can
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`“spring back” to their original shape or close thereto when released.
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`18. The availability of superelastic NiTi also led to the development of
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`rotary endodontic files (i.e., electric drills known as dental hand pieces), which was
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`seen by many as a revolution in the industry.
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`19. Although NiTi files began to be used and were a significant
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`improvement over stainless steel hand files, dentists and endodontists widely
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`recognized at the time that the superelastic NiTi rotary files tended to fracture
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`during use. The tendency to fracture was caused in part by the lateral stresses
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`placed on the file in a tooth’s curved root canal, particularly when being used in a
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`rotary hand piece (also sometimes referred to as a drill). It was also well known at
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`the time that the superelastic NiTi rotary files still caused zipping, ledging, and
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`perforation problems, similar to those caused by stainless steel hand files.
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`20. When a file breaks, a broken file piece often remains in the patient’s
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`tooth, and a dentist or endodontist must then try to remove the broken file piece.
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`10
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`
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`The graphics below illustrate a file fracture.
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`
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`21. General dentists, who are not specially certified as endodontists,
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`perform approximately 70 to 80 percent of root canals. If a general dentist
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`separates (or fractures) a file in the tooth, then the patient usually is referred to an
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`endodontist, who will try to remove the broken file from the tooth. In some cases,
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`it is not possible to remove the file without destroying the tooth. In such cases, the
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`endodontist will attempt to first file around the separated file piece and if
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`unsuccessful, will then fill around the broken file and check for a radiolucency
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`over a period of time. If a radiolucency develops or changes, then one option to
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`save the tooth would be a surgical procedure to repair the root.
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`22. The industry recognized the problem and attempted to address the
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`fracture of superelastic NiTi files. The problem was attributed to a lack of strength
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`in the files. Some manufacturers increased the diameter of the core of the files, but
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`this failed to solve the problem. Others tried to solve the fracture problem by
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`11
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`
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`increasing the taper of the file from the standard 2 percent taper up to 4 percent,
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`then 6 percent, then 8 percent and even up to 10 percent taper, resulting in thicker
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`files, but this also failed to solve the fracture problem. The larger files and
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`increased taper created stiffer files and created an additional problem because the
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`files removed more tooth structure, which then could compromise the tooth.
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`23. Through my own education and experience as an endodontist, I
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`became aware and observed that NiTi rotary files were prone to fracture inside
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`teeth. As I was not comfortable using NiTi rotary instruments, I only used hand
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`NiTi instruments to lessen the possibility of fracture of a file in a patient's tooth.
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`24. However, I began thinking of ideas and conducting research on ways
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`to address the shortcomings of existing NiTi endodontic files and to attempt to
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`solve the fracture problem, which was well recognized at the time. Ultimately, my
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`research led to the inventive process of heat-treating a completed, post-machined,
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`superelastic NiTi endodontic file as described in the ’773 patent to lessen the file’s
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`superelasticity and make it deformable to fit the shape of a canal.
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`C.
`
`The Invention of the ’773 Patent
`
`25.
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`I first began researching a way to address the fracture issue of NiTi
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`endodontic instruments in 1995. I conducted experiments and performed testing on
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`different ways to make the files more fracture resistant or resilient. I invested a
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`substantial amount of time and money conducting research on ways to improve
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`12
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`
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`existing superelastic NiTi files.
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`
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`26.
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`Initially, I considered the possibility of making a sharper file. My
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`earliest experiments were designed to coat the NiTi files in a manner that would
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`increase their cutting ability. I researched and investigated making files with a
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`diamond coating, but determined that such a process was not workable.
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`27.
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`In March 2004, I had Guhring Coating Services (a local company) add
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`a titanium nitride (TiN) coating to superelastic NiTi files. Their method applies a
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`coating using physical vapor deposition at 500°C and results in a harder material.
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`Ex. 2035 at 3. I then tested the TiN coated files using the testing methods in ISO
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`3630-1, Dentistry—Root-Canal Instruments—Part 1: General Requirements (“ISO
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`Standard 3630-1”). I was encouraged by these results.
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`28. After working with the TiN coated files, I became concerned that the
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`coating may wear off. I conducted further experiments and determined that heat-
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`treating a machined NiTi endodontic file without a coating was preferable.1 I then
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`traveled to the Maillefer facility in Switzerland in August 2004 to test these heat-
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`1 All of my heat-treatment experiments were conducted on machined NiTi
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`endodontic instruments; i.e., endodontic files with a cutting surface. At times in
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`this declaration I use the term “post-heat-treated” or “post-heat treatment” to
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`denote that the files were finished products.
`
`13
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`
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`
`
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`treated NiTi instruments according to ISO Standard 3630-1. I had obtained a non-
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`disclosure agreement with Maillefer by that time.2
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`29. The results of my laboratory testing showed that heat treatment of the
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`machined files made the files more flexible and more resilient. As a result, the files
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`were less likely to fracture during use. I also found that post-heat treatment
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`reduced the superelasticity of NiTi, making the files more easily deformable. In
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`other words, the files that had been post-heat-treated did not spring back to their
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`original shape or close thereto when released like conventional, non-heat-treated
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`superelastic NiTi files. Instead, my post-heat-treated NiTi files remained
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`substantially bent at room temperature.
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`30.
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`I performed additional testing on the post-heat-treated NiTi files using
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`model systems (e.g., clear acrylic blocks designed to give user feedback) that are
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`commonly used to evaluate endodontic files. During that testing, I observed a
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`profound difference in the performance of post-heat-treated NiTi files as compared
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`to non-heat-treated NiTi files. In particular, I unexpectedly discovered that with the
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`post-heat-treated NiTi files, it was much more difficult, if not impossible, to create
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`a ledge on the tooth’s inner surface—an undesirable feature that can occur with
`
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`2 Maillefer Instruments Holding Sarl (“Maillefer”) was a wholly owned Dentsply
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`International Inc. entity at this time.
`
`14
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`
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`untreated NiTi files. As discussed above, ledging is caused by the forces exerted
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`between the curved canal and the file. The superelastic properties of NiTi cause the
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`files to spring back against the curved canal. The post-heat-treated NiTi files do
`
`not have that property. To me, this was a “eureka” moment.
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`31. Provided below are images from a “ledge test” conducted on acrylic
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`blocks. Two ledges were created by a NiTi rotary file. The size of those ledges was
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`determined to be 0.08 mm and 0.03 mm. Only one ledge of 0.01 mm was created
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`by the post-heat-treated NiTi rotary file.
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`Ledges created by a NiTi rotary file
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`15
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`Ledges created by a post-heat-treated NiTi rotary file
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`32.
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`I performed additional testing and determined that the NiTi
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`endodontic files treated above 400°C in accordance with my claimed invention can
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`maintain at least 10 degrees of deformation upon bending to 45 degrees, using the
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`bend test in ISO Standard 3630-1. The post heat-treating process changes the shape
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`memory characteristic of the NiTi file so that the file bends easily and can retain its
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`bent shape, even at body temperature. This is an important and useful characteristic
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`for practitioners because it allows the file to follow the natural curvature of the root
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`and not create a ledge. The practitioner can remove the tissue and limit the amount
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`of tooth structure removed which is vital to maintaining the integrity of the tooth.
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`This yields a better and safer outcome for the patient.
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`33.
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`In June 2005, I filed a PCT patent application.
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`D.
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`The Claims of the ’773 Patent
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`34. Claims 1 and 13 are the only independent claims of the ’773 patent.
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`16
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`
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`Claim 1 reads as follows:
`
`
`
`A method for manufacturing or modifying an endodontic
`instrument for use in performing root canal therapy on a tooth, the
`method comprising:
`(a) providing an elongate shank having a cutting edge extending
`from a distal end of the shank along an axial length of the shank, the
`shank comprising a superelastic nickel titanium alloy, and
`(b) after step (a), heat-treating the entire shank at a temperature
`from 400 °C. up to but not equal to the melting point of the
`superelastic nickel titanium alloy,
`wherein the heat treated shank has an angle greater than 10
`degrees of permanent deformation after torque at 45 degrees of
`flexion when tested in accordance with ISO Standard 3630-1.
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`Independent claim 13 is narrower than claim 1 in four respects: first, step (a)
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`requires a shank having helical flutes; second, step (a) requires that the instrument
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`conform to ISO Standard 3630-1; third, step (a) requires the shank to consist
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`essentially of a superelastic nickel titanium alloy; and fourth, step (b) requires heat
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`treatment at 475-525°C.
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`Dependent claims 2, 6, 7, 10, 11, and 14-17 narrow the temperature range of
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`the heat treatment (475-525°C, 500°C, or 400-525°C). Dependent claims 3, 6, 7,
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`and 14 require a 1-2 hour heat treatment. Dependent claims 4-6 and 16 specify the
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`atmosphere for the heat treatment (unreactive, ambient, or any other acceptable
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`17
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`
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`heat treatment process). Dependent claim 8 requires a 0.5-1.6 mm diameter
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`instrument. Dependent claims 9 and 15 require heat treatment at a single
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`temperature. Dependent claims 7, 12, and 17 require that the superelastic nickel
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`titanium alloy be composed of 54-57% nickel and 43-46% titanium (by weight).
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`35. Each claim of the ’773 patent includes a limitation specifying that a
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`shank, once heated as described in the claim, will exhibit a particular level of
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`permanent deformation (an angle of greater than 10 degrees) after being subjected
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`to a particular level of torque (45 degrees of flexion) when tested according to the
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`procedure provided in ISO Standard 3630-1.
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`36. The Examples in the ’773 patent refer to the ISO Standard 3630-1
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`General requirements and to ANSI/ADA Specification No. 28, Endodontic files
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`and reamers. The procedure for the bend test in the international standard is the
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`same as the procedure for the bend test in the American standard.
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`E.
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`The Invention of the ’773 Patent Initially Met with Skepticism
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`37. The conventional wisdom at the time of my invention was that the
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`superelasticity of NiTi was advantageous and that softer, flexible files such as
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`those that result from my process were undesirable and in fact unsuitable. Indeed,
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`my invention was initially met with skepticism and doubt from others in the
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`industry. For example, I had a good relationship with Pierre-Luc Maillefer, the
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`General Manager of Maillefer, and Jean-Charles Giachetto, the Head of Laboratory
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`18
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`Testing at Maillefer. I requested that they commercialize my files. However, Mr.
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`Maillefer told me that the files were too soft. Despite that skepticism, he agreed to
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`organize a focus group to evaluate my heat-treated NiTi files. Maillefer selected a
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`group of practitioners and provided them with the treated and untreated files to
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`evaluate. The results from the focus group indicated that the practitioners thought
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`the files were not strong enough, and there was concern that they were too soft and
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`would easily unwind. Moreover, the practitioners in the focus group did not view
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`the ability to follow the canal as a significant benefit. After the focus group results
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`came back, Maillefer decided that it did not want to commercialize the files.
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`38.
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`I also showed my heat-treated NiTi files to two colleagues, with
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`whom I had NDAs, in our endodontic study group in Chicago and solicited their
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`feedback. Their reactions were also disappointing – one of them said he did not
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`like the files and the other said he thought the files were “just okay.” Despite the
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`lackluster responses and criticism I initially encountered from others, I knew that I
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`had made an important innovation.
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`F.
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`Efforts to Commercialize the Invention of the ’773 Patent
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`39. Having filed a PCT application in 2005, I attempted to market my
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`invention to several dental companies. As an individual endodontist, it took some
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`time to find a company to manufacture files for me (completed, post-machined
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`superelastic NiTi rotary files) that I could then heat-treat according to my
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`19
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`invention. Once I did that, I began again the efforts to commercialize my files. I
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`talked to a number of different companies, including Coltene/Whaledent
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`(“Coltene”), D&S Dental, and others about my invention, but I was repeatedly told
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`that my files were too soft. Being repeatedly rebuffed, I investigated having the
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`files manufactured for me and then heat-treating them myself.
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`40.
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`In February 2009, I met with representatives from Coltene, a large
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`dental company, and at that time, it seemed very interested. We signed a secrecy
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`agreement and I met with them in Chicago, Illinois, in August 2010. Coltene was
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`still very interested in my files at that time and it asked that I provide a sample,
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`which I did, in accordance with the terms of the non-disclosure agreement. A copy
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`of the NDA is attached as Exhibit 2039. Discussions continued and I met with
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`Coltene representatives in Cuyahoga Falls, Ohio in November 2010; Chicago in
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`February 2011; and then again at the Greater New York Dental Meeting in
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`November 2011 (after I received my first patent). Ultimately, we were unable to
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`reach an agreement and did not pursue commercialization of my files.
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`41.
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`In May of 2010, I was contacted by a company called D&S Dental
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`(“D&S”), a company located in Johnson City, Tennessee. D&S manufactures and
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`sells dental instruments. The person from D&S who contacted me directly was
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`Mr. Bobby Bennett, now one of the real parties in interest in this proceeding.
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`Mr. Bennett now is also a co-owner of Petitioner, US Endodontics, LLC (“US
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`20
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`
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`Endo”).
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`42.
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`In May 2010, Mr. Bennett was the vice president and general manager
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`at D&S. He invited me come to D&S facility in Tennessee for a meeting and
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`discussed the need for an NDA. Prior to my visit, during a telephone conversation,
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`Mr. Bennett told me that he had received one of my files from Coltene and that
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`D&S was interested in the technology. I was quite disappointed to learn that
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`Coltene had given my file to its supplier/competitor and thereby violated the NDA
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`that I had with them. D&S confirmed in writing that the purpose of the meeting
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`would be to “negotiate a licensing and royalty agreement for the assignment of the
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`intellectual property” that I had developed, “or a similar structure that will lead to
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`commercialization,” as shown in the email attached as Exhibit 2040.
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`43. Discussions with Mr. Bennett continued, and as early as July 2010, he
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`indicated that D&S intended to negotiate an agreement with my company whereby
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`D&S would purchase the rights to my inventions and would pay me a royalty on
`
`the products it sold that use my technology. It is my understanding that Mr.
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`Bennett was relieved of his duties in October 2010. After Mr. Bennett left D&S, I
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`had one final discussion with one of the D&S owners, Mr. Derek Heath in
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`November 2011 at the Greater New York Dental Meeting. No further discussions
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`were conducted with D&S and I did not enter into any formal license agreement
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`with D&S.
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`21
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`44. After my first patent issued in November 2011, I contacted a number
`
`of companies at the Greater New York Dental Meeting. I continued efforts to
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`commercialize my invention and had discussions with other companies, including
`
`Brasseler, Integra Miltex, Sybron, and Dentsply. Then, in 2014, Dentsply
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`International Inc. and its subsidiary, Tulsa Dental Products LLC (collectively
`
`“Dentsply”) “pulled the trigger” and entered into a licensing agreement with Gold
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`Standard for my patents, including the ’773 patent. This was nearly ten years after
`
`I first produced my heat-heated files.
`
`G. The Invention of the ’773 Patent is Commercially Successful
`
`45. Dentsply manufactures and sells a post-heat-treated NiTi file known
`
`as Vortex Blue®, which I understand is made using a process that is covered by the
`
`claims of the ’773 patent. Ex. 2006, ¶ 9. The Vortex Blue® file appears to be a
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`commercially successful product, as it is still remains on the market.
`
`46. Moreover, a number of companies, including US Endo (Petitioner),
`
`Edge Endo LLC (Petitioner’s sister company and distributor), D&S, and Coltene
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`have all introduced commercial products that are heat-treated NiTi rotary files.
`
`Exs. 2012, 2042.
`
`H.
`
`Prosecution History of the ’991 Patent
`
`47.
`
`I understand that Petitioner in this matter has argued that the
`
`“wherein” clause of claims 1 and 13 of the ’773 patent can be met “by a heat
`
`22
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`
`
`
`treated file with an austenite finish temperature (Af) above mouth temperature.”3 I
`
`disagree with Petitioner’s incorrect interpretation of the claims. The wherein clause
`
`of the ’773 patent requires that the NiTi files be heat-treated according to the
`
`claimed method must have “an angle of greater than 10 degrees of permanent
`
`deformation” when tested in accordance the bend test described in ISO Standard
`
`3630-1. The claims do not refer to the austenite finish temperature of the treated
`
`files, nor do they define the invention based on the crystalline structure of the
`
`treated files.
`
`48.
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`I understand that Petitioner is relying on statements contained in the
`
`prosecution history of the ’991 patent as a basis for its incorrect interpretation.
`
`Specifically, Petitioner is relying on paragraphs 4-6 of the declaration I submitted
`
`to the Patent Office on July 9, 2014. Paper 37 at 3-4; Ex. 1030 at 125-32.
`
`49. Paragraphs 4-6 of my July 9, 2014 Declaration read as follows:
`
`Paragraph 4
`
`I conducted a study to show that endodontic instruments heat
`4.
`treated at 375°C will 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
`
`
`3 The temperature inside the mouth, or body temperature, varies by individual but
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`is generally considered to be approximately 37°C.
`
`23
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`
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`independent claims 1, 6 and 11 of my present patent application. I
`obtained endodontic instruments in accordance with ISO Standard
`3630-1 made from a titanium alloy comprising 54-57 weight percent
`nickel and 43-46 weight percent titanium and including an elongate
`shank having a cutting edge extending from a distal end of the shank
`along an axial length of the shank. I heat-treated a first batch of these
`instruments in a furnace at 375ºC for 120 minutes. I heat-treated a
`second batch of these instruments in a furnace at 400°C for 120
`minutes. I heat-treated a third batch of these instruments in a furnace
`at 500°C for 90 minutes. I used differential scanning calorimetry
`(DSC) on these heat-treated endodontic instruments to determine the
`phase of these heat treated endodontic instruments.
`
`Paragraph 5
`
`The DSC of the endodontic instruments heat-treated at 375°C,
`5.
`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.
`
`Paragraph 6
`
`The results of my DSC tests corroborate a study that was
`6.
`published after the filing date of my application. Specifically, M.H.
`Elahinia et al. show in Figure 4 (below) of "Manufacturing and
`
`24
`
`
`
`
`
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`processing of NiTi implants: A review", Progress in Materials
`Science, 57: 911-46, June 2012, that instruments heat-treated between
`300°C and 400°C will have a phase such that an angle greater than 10
`degrees of permanent deformation after torque at 45° of flexion when
`tested in accordance with ISO Standard 3630-1 will be achieved.
`
`Ex. 1030 at 126-27.
`
`50. As noted in the declaration, I heat-treated three batches of endodontic
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`files made from a NiTi alloy having the composition described in the ’991 patent.
`
`The heat treatments were conducted in a furnace. I obtained differential scanning
`
`calorimetry (“DSC”) thermograms for the post-heat-treated files. I also conducted
`
`a bend test on the post-heat-treated files. Although I did not perform the ISO
`
`Standard 3630-1 bend test, which requires 45 degrees of flexion, I did perform an
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`“informal” bend test using at least 45 degrees of flexion. I tested files from each of
`
`the three batches by applying a force to the tip of the file.
`
`51.
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`I did not report the informal bend test in my July 9, 2014 declaration
`
`because I did not measure the exact angle of the bend or record the angle of
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`permanent deformation. However, I observed that the files stayed deformed at a
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`substantial angle and did not spring back to their original shape (or close thereto).
`
`52. Furthermore, the files that I tested during this experiment were ISO
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`standard (2% taper) NiTi endodontic files, and are the same files that were
`
`manufactured specifically for me by Integra Miltex. Over a five-year period, I
`
`25
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`conducted extensive research and testing on the files post-heat-treated for me by
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`Integra Miltex. Dentsply now supplies me with post-heat-treated ISO standard
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`NiTi endodontic files. I, therefore, have become familiar with the mechanical
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`behavior of post-heat-treated NiTi files made from different manufacturers. I am
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`also familiar the DSC results obtained after various heat treatments.
`
`53.
`
`I have conducted similar “informal” bend tests to those mentioned
`
`above. For example, I submitted images of a bend test to the Patent Office during
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`the prosecution of the ’773 patent. Ex. 1008 at 115-16. That bend test applied at
`
`least 45 degrees of flexion. Certain images are reproduced below.
`
`Image showing a bending force being applied to a NiTi file (over 45 degrees)
`
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`
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`26
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`
`
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`Image showing a non-heat-treated NiTi file “springing back” to its original
`shape after release of the bending force
`
`
`Image showing a heat-treated NiTi file remaining permanently deformed after
`release of the bending force
`
`
`
`
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`54. Based on my knowledge and personal experience with the post-heat-
`
`treated NiTi files from Integra Miltex and Dentsply, the DSC results from past heat
`
`treatments, and my observations from the “inform
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