Notice of References Cited
`
`Application/Control No.
`
`13/455,841
`
`Examiner
`
`MATTHEW NELSON
`
`U.S. PATENT DOCUMENTS
`
`Applicant(s)/Patent Under
`Reexamination
`LUEBKE, NEILL HAMIL TON
`
`Art Unit
`
`3776
`
`Page 1 of 2
`
`Document Number
`Country Code-Number-Kind Code
`
`A US-4,490, 112 A
`
`US-5,080,584 A
`B
`c US-5,380,200 A
`D US-5,653,590 A
`E US-5,775,902 A
`US-6,206,695 81
`
`F
`
`US-6,375,458 81
`
`G
`H US-6,431 ,863 81
`US-6,428,634 81
`
`*
`*
`*
`*
`*
`*
`*
`*
`*
`*
`*
`*
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`US-2004/0129352 A 1
`L
`* M US-2004/0193246 A 1
`
`I
`
`J
`
`K
`
`US-2002/0191878 A 1
`
`US-2004/0121283 A 1
`
`Date
`MM-YYYY
`
`12-1984
`
`Tanaka et al.
`
`01-1992
`
`Karabin, Roger J.
`
`01-1995
`
`Heath et al.
`
`08-1997
`
`Heath et al.
`
`07-1998
`
`Matsutani et al.
`
`03-2001
`
`Wong et al.
`
`04-2002
`
`Moorleghem et al.
`
`08-2002
`
`Sachdeva et al.
`
`08-2002
`
`Bessel ink et al.
`
`12-2002
`
`Ueda et al.
`
`06-2004
`
`Mason, Robert M.
`
`07-2004
`
`Shiota, Hiroyuki
`
`09-2004
`
`Ferrera, David A.
`
`Name
`
`Classification
`
`433/20
`
`433/20
`
`433/102
`
`433/102
`
`433/102
`
`433/102
`
`433/2
`
`433/102
`
`148/421
`
`384/492
`
`433/102
`
`148/527
`
`623/001.15
`
`*
`
`Document Number
`Country Code-Number-Kind Code
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`Country
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`Name
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`
`FOREIGN PATENT DOCUMENTS
`
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
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`
`U.S. Patent and Trademark Office
`PT0-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20130110
`
`

`
`Applicant(s)/Patent Under
`Reexamination
`LUEBKE, NEILL HAMIL TON
`
`Art Unit
`
`3776
`
`Page 2 of 2
`
`Classification
`
`606/151
`
`433/102
`
`*
`*
`*
`
`Notice of References Cited
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`Document Number
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`Date
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`Application/Control No.
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`13/455,841
`
`Examiner
`
`MATTHEW NELSON
`
`U.S. PATENT DOCUMENTS
`
`Name
`
`A
`
`US-2005/0090844 A 1
`
`04-2005
`
`Patel et al.
`
`11-2006
`
`Matsutani et al.
`
`US-7,137,815 82
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`Country
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`Name
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`
`FOREIGN PATENT DOCUMENTS
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`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`*
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`PT0-892 (Rev. 01-2001)
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`PTO/SB/08a (04-07)
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`Copy of International Search Report corresponding to PCT/US2005/019947, under date
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`·····--·············- ·······-··t---·-----------·--- ----------------
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`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant:
`Filed:
`For:
`
`Neill H. Luebke
`Herewith
`Dental and Medical Instruments Comprising Titanium
`
`INFORMATION DISCLOSURE STATEMENT
`
`Commissioner For Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`Pursuant to 37 CFR 1.97-1.98, Applicants are submitting herewith a listing of
`
`documents on an Information Disclosure Statement.
`
`The references cited on the attached Information Disclosure Statement have
`
`already been cited and submitted by the Applicants or Examiner in U.S. Patent
`
`Application No. 13/455,841
`
`from which
`
`the present application claims priority.
`
`Therefore, Applicants are not submitting copies with this submission.
`
`The submission of the listed documents is not intended as an admission that any
`
`such document constitutes prior art against the claims of the present application.
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`Applicants do not waive any rights to take any action that would be appropriate to
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`antedate or otherwise remove any listed document as a competent reference against the
`
`claims of the present application.
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`Applicants respectfully request that the listed documents be considered by the
`
`Examiner, be made of record in the present application and that an initialed copy of the
`
`Information Disclosure Statement by Applicant be returned in accordance with MPEP §
`
`609.
`
`Date: January 29, 2014
`
`Respectfully submitted,
`
`/Richard T. Roche/
`Richard T. Roche, Reg. No. 38,599
`Attorney for Applicant
`Quarles & Brady LLP
`411 E. Wisconsin Ave.
`Milwaukee, WI 53202
`414-277-5805
`
`QB\115207.00011 \24859216.1
`
`

`
`Dental and Medical Instruments Comprising Titanium
`
`Docket No.: 115207.00011
`
`CROSS-REFERENCES TO RELATED APPLICATIONS
`
`[0001]
`
`This application is a continuation of U.S. Patent Application No. 13/455,841
`
`filed April 25, 2012, which is a continuation of U.S. Patent Application No. 13/336,579
`
`filed December 23, 2011, now U.S. Patent No. 8,562,341, which is a continuation of
`
`5
`
`U.S. Patent Application No. 12/977,625 filed December 23, 2010, now U.S. Patent
`
`No. 8,083,873, which is a divisional application of U.S. Patent Application No.
`
`11/628,933, now U.S. Patent No. 8,062,033, filed December 7, 2006 which is a 371
`
`of PCT/US05/19947 filed June 7, 2005 which claims priority from United States
`
`Patent Application No. 60/578,091 filed June 8, 2004.
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`10
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`STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
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`[0002]
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`Not Applicable.
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`15
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`1. Field of the Invention
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`BACKGROUND OF THE INVENTION
`
`[0003]
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`The invention relates to instruments used in medicine and dentistry. More
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`particularly, the invention relates to medical and dental instruments such as drills,
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`burs and files, and to endodontic instruments such as drills, burs and files used by
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`dentists.
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`20
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`2. Description of the Related Art
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`[0004]
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`Endodontics or root canal therapy is the branch of dentistry that deals with
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`diseases of the dental pulp and associated tissues. One aspect of endodontics
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`comprises the treatment of infected root canals by removal of diseased pulp tissues
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`and subsequent filling.
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`25
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`[0005]
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`Figure 1 shows a representation of a tooth to provide background. Root
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`canal therapy is generally indicated for teeth having sound external structures but
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`having diseased, dead or dying pulp tissues. Such teeth will generally possess intact
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`enamel 1 0 and dentin 12, and will be satisfactorily engaged with the bony tissue 20,
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`by among other things, healthy periodontal ligaments 18. In such teeth, the pulp
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`tissue 14, and excised portions of the root 16, should be replaced by a biocompatible
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`substitute. Figure 1 also shows the apical foramen 22 through which blood and
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`nerves pass to support the pulp tissues.
`[0006] One method for the preparation of a root canal for filling is represented by
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`5
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`Figures 2a-2e. A tooth having a basically sound outer structure 24 but diseased pulp
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`26, is cut with conventional or coated dental drill 28 creating a coronal access
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`opening 30. A broach is used for gross removal of pulp material 26 from the root
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`canal through the coronal access opening 30. The void 32 formed is enlarged as in
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`10
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`Figure 2d with file 34, to result in a fully excavated cavity 36. Debris is removed from
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`this cavity by flushing and the cavity cleansed to remove all diseased tissue. The
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`excavated canal is then ready for filling.
`[0007]
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`During this procedure, small endodontic instruments (e.g., file 34) are
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`utilized to clean and enlarge the long narrow tapered root canals. While most files
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`15
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`perform entirely satisfactorily when cleaning and enlarging a straight root canal,
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`problems have been encountered when using certain files to clean and enlarge a
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`curved root canal. As will be understood by those skilled in the art, a very large
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`portion of the root canals encountered by a practicing dentist and/or endodontist are
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`of the curved variety, and thus this problem is a significant one for the profession.
`[0008] When performing an operation on a curved root canal with a smaller
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`20
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`diameter file, the file can easily be inserted into the curved canal and will easily bend
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`to fit the curved shape of the canal due to the flexibility of the small diameter file. In
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`Figure 1 a, there is shown the file 34 of Figure 2d in a bent position. The file 34 has a
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`shank 42 mounted at its proximate end 47 to a handle 43. The shank 42 may include
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`25
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`calibrated depth markings 45 and further includes a distal end 48. The shank 42
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`includes two continuous helical flutes 51 as shown in Figure 1 b that extend along its
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`lower portion. The flutes 51 define a cutting edge. A helical land 53 is positioned
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`between axially adjacent flutes as shown in Figure 1 b.
`[0009] While file 34 can easily bend to fit the curved shape of a canal due to the
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`30
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`flexibility of the small diameter shank 42, with increasingly larger sizes of files, the file
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`- 2-
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`becomes significantly less flexible and becomes more and more difficult to insert
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`through the curved portion of the canal. In some cases, the relatively inflexible file
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`will cut only on the inside of the curve and will not cut on the outside of the curvature
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`of the root canal. Thus, the problems, which occur during the therapy of a root canal,
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`5
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`are often the result of the basic stiffness of the files, particularly with the respect to
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`the instruments of larger diameter.
`[0010]
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`Various solutions have been proposed to limit the problems encountered
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`when cleaning and enlarging a curved root canal with a file. For example, U.S.
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`Patent No. 4,443,193 describes a shaped endodontic instrument that is said to solve
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`10
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`this problem. U.S. Patent No. 5,380,200 describes an endodontic instrument having
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`an inner core and an outer shell wherein one of the cores or shell is a nickel-titanium
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`alloy and the other core or shell is selected from stainless steel, titanium alpha alloy,
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`titanium beta alloy, and titanium alpha beta alloy. (For background on beta-titanium,
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`see U.S. Patent Nos. 4,197,643; 4,892,479; 4,952,236; 5,156,807; 5,232,361;
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`15
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`5,264,055; 5,358,586; 5,947,723; 6,132,209; and 6,258,182.) U.S. Patent No.
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`5,464,362 describes an endodontic instrument of a titanium alloy that is machined
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`under certain specific operating parameters to produce an instrument having high
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`flexibility, high resistance to torsion breakage, and sharp cutting edges. U.S. Patent
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`No. 6,315,558 proposes the use of superelastic alloys such as nickel-titanium that
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`20
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`can withstand several times more strain than conventional materials without
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`becoming plastically deformed. This property is termed shape memory, which allows
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`the superelastic alloy to revert back to a straight configuration even after clinical use,
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`testing or fracture (separation).
`[0011]
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`In spite of the aforementioned advances, there remains a need for medical
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`25
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`and dental instruments, and particularly endodontic instruments, such as drills, burs
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`and files, that have high flexibility, have high resistance to torsion breakage, maintain
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`shape upon fracture, can withstand increased strain, and can hold sharp cutting
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`edges.
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`30
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`- 3 -
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`

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`SUMMARY OF THE INVENTION
`
`[0012]
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`The present invention overcomes the problems encountered when
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`cleaning and enlarging a curved root canal. In one aspect, the invention provides an
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`endodontic instrument for use in performing root canal therapy on a tooth. The
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`5
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`instrument includes an elongate shank having a cutting edge extending from a distal
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`end of the shank along an axial length of the shank. The shank comprises a titanium
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`alloy, and the shank is prepared by heat-treating the shank at a temperature above
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`25°C in an atmosphere consisting essentially of a gas unreactive with the shank.
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`The shank has high flexibility, high resistance to torsion breakage, maintains shape
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`10
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`upon fracture, can withstand increased strain, and can hold sharp cutting edges.
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`Thus, it solves the problems encountered when cleaning and enlarging a curved root
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`canal.
`[0013]
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`In another aspect, the invention provides an endodontic instrument for use
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`in performing root canal therapy on a tooth. The instrument has an elongate shank
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`15
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`having a cutting edge extending from a distal end of the shank along an axial length
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`20
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`25
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`of the shank. The shank consists essentially of a titanium alloy selected from alpha(cid:173)
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`titanium alloys, beta-titanium alloys, and alpha-beta-titanium alloys. The shank
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`avoids the use of complex two material systems that are expensive to produce and
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`are prone to delamination of the materials. This version of the invention also solves
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`the problems encountered when cleaning and enlarging a curved root canal.
`[0014]
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`These and other features, aspects, and advantages of the present
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`invention will become better understood upon consideration of the following detailed
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`description, drawings, and appended claims.
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`[0015]
`[0016]
`[0017]
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`Figure 1 is a cross-sectional view of a tooth.
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`Figure 1 a is a side elevational view of an endodontic instrument.
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`Figure 1 b is a partial detailed view of the shank of the endodontic
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`instrument shown in Figure 1 a.
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`[0018]
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`Figures 2a-2e represent a prior art procedure for preparing a tooth for
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`endodontic restoration.
`[0019]
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`Figure 3 is a graph showing the results of a study of torsion (Mt) reported in
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`g,:,cm performed in accordance with "ISO Standard 3630-1 Dentistry- Root-canal
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`5
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`instruments- Part 1: General requirements and ANSI/ADA Specification No. 28,
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`Endodontic files and reamers" for untreated (Control) files, heat-treated files (TT),
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`and titanium nitride coated files (Ti-N).
`[0020]
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`Figure 4 is a graph showing the results of a study of torsion (At) reported in
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`degrees of deflection performed in accordance with "ISO Standard 3630-1 Dentistry-
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`10
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`Root-canal instruments- Part 1: General requirements and ANSI/ADA Specification
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`No. 28, Endodontic files and reamers" for untreated (Control) files, heat-treated files
`
`(TT), and titanium nitride coated files (Ti-N).
`[0021]
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`Figure 5 is a graph showing the results of a study of maximum torque at
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`45° of flexion (Mf) reported in g,:,cm performed in accordance with "ISO Standard
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`15
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`3630-1 Dentistry- Root-canal instruments- Part 1: General requirements and
`
`ANSI/ADA Specification No. 28, Endodontic files and reamers" for untreated (Control)
`
`files, heat-treated files (TT), and titanium nitride coated files (Ti-N).
`
`[0022]
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`Figure 6 is a graph showing the results of a study of angle of permanent
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`deformation after the flexion test (ADP) reported in degrees of deflection performed in
`
`20
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`accordance with "ISO Standard 3630-1 Dentistry- Root-canal instruments- Part 1:
`
`General requirements and ANSI/ADA Specification No. 28, Endodontic files and
`
`reamers" for untreated (Control) files, heat-treated files (TT), and titanium nitride
`
`coated files (Ti-N).
`[0023]
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`Figure 7 is a graph showing the results of a study of fatigue reported in
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`25
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`cycles (revolutions) to failure for untreated (Control) files, heat-treated files (TT), and
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`titanium nitride coated files (Ti-N). This study was performed in accordance with the
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`ISO Standard 3630-2 Dental root-canal instruments- Part 2: Enlargers and
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`ANSI/ADA Specification No. 95, for Root canal enlargers".
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`

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`DETAILED DESCRIPTION OF THE INVENTION
`
`[0024] One embodiment of the invention provides an improved endodontic
`
`instrument for use in performing root canal therapy on a tooth. This embodiment of
`
`the invention is an endodontic instrument as shown in Figure 1 a that includes an
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`5
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`elongate shank 42 mounted at its proximate end 47 to a handle 43. The shank 42
`
`may be about 30 millimeters long. The proximate end 47 may have a diameter of
`
`about 0.5 to about 1.6 millimeters. The shank 42 may include calibrated depth
`
`markings 45 and further includes a distal end 48. The shank 42 includes two
`
`continuous helical flutes 51 as shown in Figure 1 b that extend along its lower portion.
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`10
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`The flutes 51 define a cutting edge. A helical land 53 is positioned between axially
`
`adjacent flutes as shown in Figure 1 b.
`[0025]
`
`The shank 42 comprises a titanium alloy, and is prepared by heat-treating
`
`the shank at a temperature above 25°C in an atmosphere consisting essentially of a
`
`gas unreactive with the shank. Preferably, the temperature is from 400oc up to but
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`15
`
`not equal to the melting point of the titanium alloy, and most preferably, the
`
`temperature is from 475°C to 525°C. Preferably, the gas is selected from the group
`
`consisting of helium, neon, argon, krypton, xenon, and radon. Most preferably, the
`
`gas is argon. In one example embodiment, the shank is heat-treated for
`
`approximately 1 to 2 hours. In another example embodiment, the shank is heat-
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`20
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`treated at 500oc for 75 minutes. However, other temperatures are suitable as they
`
`are dependent on the time period selected for heat exposure.
`[0026]
`
`The titanium alloy may be selected from alpha-titanium alloys, beta-
`
`titanium alloys, alpha-beta-titanium alloys, and nickel-titanium alloys. Non-limiting
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`examples of alpha-titanium alloys, beta-titanium alloys, alpha-beta-titanium alloys for
`
`25
`
`use in this embodiment of the invention are: Ti-5AI-2.5Sn alpha alloy; Ti-5AI-2.5Sn(cid:173)
`ELI (low 0 2) alpha alloy; Ti-3AI-2.5V alpha alloy; Ti-5AI-5Zr-5Sn alpha alloy; Ti-6AI-
`2Cb-1Ta-0.8Mo alpha alloy; Ti-5AI-5Sn-2Zr-2Mo-0.25Si near alpha alloy; Ti-6AI-2Nb-
`
`1Ta-1Mo near alpha alloy; Ti-8AI-1Mo-1V near alpha alloy; Ti-6AI-2Sn-4Zr-2Mo near
`
`alpha alloy; Ti-6AI-2Sn-1.5Zr-1 Mo-0.35Bi-0.1 Si near alpha alloy; Ti-2.25-AI-11 Sn-
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`30
`
`5Zr-1 Mo-0.2Si near alpha alloy; Ti-3AI-2.5V alpha-beta alloy; Ti-1 OV-2Fe-3AI alpha-
`
`- 6-
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`

`
`beta alloy; Ti-5AI-2Sn-2Zr-4Mo-4Cr alpha-beta alloy; Ti-6AI-2Sn-4Zr-6Mo alpha-beta
`
`alloy; Ti-4AI-4Mn alpha-beta alloy; Ti-6AI-2Sn-2Zr-2Mo-2Cr-0.25Si alpha-beta alloy;
`
`Ti-4AI-3Mo-1V alpha-beta alloy; Ti-6AI-2Sn-4Zr-6Mo alpha-beta alloy; Ti-11 Sn-5Zr-
`
`2AI-1 Mo alpha-beta alloy; Ti-6AI-4V alpha-beta alloy; Ti-6AI-4V-ELI (low 02) alpha-
`
`5
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`beta alloy; Ti-6AI-6V-2Sn-0.75Cu alpha-beta alloy; Ti-7AI-4Mo alpha-beta alloy; Ti-
`
`6AI-2Sn-4Zr-2Mo alpha-beta alloy; Ti-5AI-1.5Fe-1.5Cr-1.5Mo alpha-beta alloy; Ti-
`
`8Mn alpha-beta alloy; Ti-8Mo-8V-2Fe-3AI beta alloy; Ti-11.5Mo-6Zr-4.5Sn beta alloy;
`
`Ti-3AI-8V-6Cr-4Mo-4Zr