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`PROVISIONAL APPLICATION FOR PATENT COVER SHEET
`This is a request for filing a PROVISIONAL APPLICATION FOR PATENT under 37 CFR 1.53(c).
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`Given Name
`Neill H.
`
`Name or Surname
`Luebke
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`Dental and Medical Instruments Comprising Titanium and Dental and Medical Instruments Having a Coating
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`1 of 16
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`IPR2015-00632 - Ex. 1011
`US ENDODONTICS, LLC., Petitioner
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`

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`First Named Inventor Neill H. Luebke
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`210 Extension for reply within second month
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`2001 385
`1001 770
`1002 340
`2002 170
`1003 530
`2003 265
`1004 770
`2004 385
`1005 160
`2005
`80
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`Utility filing fee ~
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`2401
`330
`1401
`2402
`330
`1402
`2403
`290
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`1451 1,510 1451 1,510 Petition to institute a public use proceeding
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`2452
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`110
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`Design filing fee
`Plant filing fee
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`Provisional filing fee
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`1453 1,330 2453
`2. EXTRA CLAIM FEES FOR UTILITY AND REISSUE 1501 1,330 2501
`Fee from
`E~t~~~r bi:ls:a.
`Fee Paid
`1502
`480
`2502
`I 1503
`Total Claims [=:=1 -20* =
`xl
`l~o.oo
`840
`2503
`I 1460
`Independent [=:=1 -3** =
`xl
`l~o.oo
`1460
`130
`Claims
`I 1807
`H
`I
`Multiple Dependent
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`665 Petition to revive - unintentional
`665 Utility issue fee (or reissue)
`240 Design issue fee
`320 Plant issue fee
`130 Petitions to the Commissioner
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`50 Processing fee under 37 CFR 1.17(q)
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`50
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`1807
`
`8021
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`1806
`
`180
`
`8021
`
`40
`
`1809
`
`770
`
`1810
`
`770
`
`1801 770 2801
`1802
`900 1802
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`9 Claims in excess of 20
`18
`2202
`1202
`Independent claims in excess of 3
`43
`1201
`2201
`86
`2203 145 Multiple dependent claim, if not paid
`1203 290
`** Reissue independent claims
`over original patent
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`1204
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`86
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`2204
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`43
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`1205
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`18
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`2205
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`9
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`I<$) 0.00
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`{Complete (if applicable))
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`I Telephone 414-277-5805
`. I RichardT. Roche
`N:.~LA- "'~F 7': • fC,..,.IA_fi2.
`I Date
`I
`1 6-8-2004
`WARNING: Information on this form may become public. Credit card information should not
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`If you need assistance in completing the form, ca/11-800-PT0-9199 and select option 2.
`
`2 of 16
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`IPR2015-00632 - Ex. 1011
`US ENDODONTICS, LLC., Petitioner
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`••
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`Express Mail Label No. EV 375545146 US
`
`Attorney Docket No.: 115207.00002
`
`Dental and Medical Instruments Comprising Titanium and
`Dental and Medical Instruments Having a Coating
`
`CROSS-REFERENCES TO RELATED APPLICATIONS
`
`[0001]
`
`Not Applicable.
`
`STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
`
`[0002]
`
`Not Applicable.
`
`- 5
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`BACKGROUND OF THE INVENTION
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`1. Field of the Invention
`[0003]
`The invention relates to instruments used in medicine and dentistry.
`
`More particularly, the invention relates to medical and dental instruments such as
`drills, burs and files, and to endodontic instruments such as drills, burs and files
`
`used by dentists.
`2. Description of the Related Art
`Endodontics or root canal therapy is the branch of dentistry that deals
`[0004]
`with diseases of the dental pulp and associated tissues. One aspect of
`
`endodontics comprises the treatment of infected root canals by removal of
`diseased pulp tissues and subsequent filling of the pulp canal (root canal).
`Figure 1 shows a representation of a tooth to provide background. Root
`[0005]
`canal therapy is generally indicated for teeth having sound external structures but
`having diseased, dead or dying pulp tissues. Such teeth will generally possess
`intact enamel 10 and dentin 12, and will be satisfactorily engaged with the bony
`tissue 20, by among other things, healthy periodontal ligaments 18. In such teeth,
`the pulp tissue 14, and excised portions of the root 16, should be replaced by a
`biocompatible substitute. Figure 1 also shows the apical foramen 22 through
`which blood and nerves pass to support the pulp tissues.
`[0006] One method for the preparation of a root canal for filling is represented
`by Figures 2a-2e. A tooth having a basically sound outer structure 24 but
`
`diseased pulp 26, is cut with conventional or coated dental drill 28 creating a
`coronal access opening 30. A broach is used for gross removal of pulp material
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`26 from the root canal through the coronal access opening 30. The void 32
`formed is enlarged as in Figure 2d with reamers and/or files 34, to result in a fully
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`excavated cavity 36. Debris is removed from this cavity by flushing and the cavity
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`cleansed to remove all diseased tissue. The excavated canal is then ready for
`
`filling.
`[0007]
`During this procedure, small endodontic instruments (e.g., files) are
`utilized to clean and enlarge the long narrow tapered root canals. While most files
`perform entirely satisfactorily when cleaning and enlarging a straight root canal,
`problems have been encountered when using certain files to clean and enlarge a
`curved root canal. As will be understood by those skilled in the art, a very large
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`5
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`portion of the root canals encountered by a practicing dentist and/or endodontist
`are of the curved variety, and thus this problem is a significant one for the
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`10
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`profession.
`[0008] When performing an operation on a curved root canal with a smaller
`diameter file, the file can easily be inserted into the curved canal and will easily
`bend to fit the curved shape of the canal due to the flexibility of the small diameter
`
`file. However, with increasingly larger sizes of files, the file becomes significantly
`less flexible and becomes more and more difficult·to insert through the curved
`portion of the canal. In some cases, the relatively inflexible file will cut only on the
`
`outside of the curve and will not cut on the inside of the curvature of the root
`canal. Thus, the problems which occur during the therapy of a root canal are
`
`often the result of the basic stiffness of the files, particularly with the respect to the
`instruments of larger diameter.
`[0009]
`Various solutions have been proposed to limit the problems
`encountered when cleaning and enlarging a curved root canal with a file. For
`example, U.S. Patent No. 4,443,193 describes a shaped endodontic instrument
`that is said to solve this problem. U.S. Patent No. 5,464,362 describes an
`
`endodontic instrument of a titanium alloy that is machined under certain specific
`
`operating parameters to produce an instrument having high flexibility, high
`resistance to torsion breakage, and sharp cutting edges. U.S. Patent No.
`6,315,558 proposes the use of superelastic alloys such as nickel titanium that can
`withstand several times more strain than conventional materials without becoming
`plastically deformed.
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`[0010]
`It has also been proposed to manufacture orthodontic appliances from
`beta-titanium. However, it is believed that this material has not been proposed for
`
`endodontic instruments. For background on beta-titanium, see U.S. Patent Nos.
`4, 197,643; 4,892,479; 4,952,236; 5, 156,807; 5,232,361; 5,264,055; 5,358,586;
`5,947,723; 6, 132,209; and 6,258,182.
`[0011]
`In spite of the aforementioned advances, there remains a need for
`medical and dental instruments, and particularly endodontic instruments, such as
`
`drills, burs and files, that have high flexibility, have high resistance to torsion
`breakage, maintain shape upon fracture, can withstand increased strain, and can
`hold sharp cutting edges.
`
`SUMMARY OF THE INVENTION
`
`The present invention overcomes the problems encountered when
`
`[0012]
`cleaning and enlarging a curved root canal. In one aspect, the invention provides
`endodontic instruments fabricated from beta-titanium. These instruments have
`
`improved sharpness, cutting ability, and instrument longevity compared to
`instruments fabricated from nickel-titanium. Also, beta-titanium is superior
`because it is harder and hence will hold an edge better and still maintains near the
`flexibility of nickel-titanium to negotiate curved canals. Thus, endodontic
`instruments fabricated from beta-titanium according to the invention limit the
`problems encountered when cleaning and enlarging a curved root canal.
`[0013]
`In another aspect, the invention provides for coating and/or heat-
`treating instruments including coatings to maintain and/or improve their
`
`sharpness, cutting ability, and/or instrument longevity and heat treatment(s) that
`improve their sharpness, cutting ability, and/or instrument longevity. Thus,
`endodontic instruments fabricated with such coating and/or heat treatment
`according to the invention limit the problems encountered when cleaning and
`enlarging a curved root canal. In one embodiment, the instrument includes a
`nickel-titanium substrate, and a coating on the substrate wherein the coating
`
`comprises a material selected from the group consisting of titanium nitride,
`titanium carbonitride, titanium aluminum nitride, aluminum titanium nitride, and
`mixtures thereof.
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`These and other features, aspects, and advantages of the present
`
`[0014]
`invention will become better understood upon consideration of the following
`detailed description, drawings, and appended claims.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Figure 1 is a cross-sectional view of a tooth.
`Figures 2a-2e represent a prior art procedure for preparing a tooth for
`
`[0015]
`[0016]
`endodontic restoration.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0017]
`
`In one aspect, the present invention relates to medical and dental
`
`instruments fabricated from beta-titanium, an alloy of titanium that includes a
`stabilizing amount of a metal selected from the group consisting of molybdenum,
`columbium, tantalum, vanadium, zirconium, and niobium; a eutectoid beta
`stabilizer selected from the group consisting of chromium, cobalt, nickel,
`manganese or iron; and at least one metallic alpha stabilizer selected from the
`
`group consisting of aluminum and lanthanum. These instruments have improved
`sharpness, cutting ability, and instrument longevity than instruments fabricated
`from nickel-titanium. Beta-titanium is superior because it is harder and hence will
`hold an edge better and still maintains near the flexibility of nickel-titanium to
`negotiate curved canals. These beta-titanium instruments may include medical,
`dental and endodontic instruments (both hand and engine driven), cutting burs
`(drills), and enlarging instruments including hand, mechanical and rotary.
`[0018]
`Present medical and dental practice entails cutting of hard tissues such
`
`as bone or teeth with instruments manufactured of carbide steel, stainless steel
`and nickel-titanium. Present endodontic practice entails the preparation, cleaning,
`and shaping of root canals in teeth utilizing carbide steel, stainless steel and
`nickel-titanium instruments for hand, mechanical and rotary applications. This
`invention would use the metal alloy beta-titanium to fabricate these instruments. It
`may be coated (as described below) or uncoated. Today a growing number of
`physicians and dentists (endodontists) are utilizing engine driven drills and files
`with various names and applications. This aspect of the present invention pertains
`to the fabrication of these cutting instruments such as drills and files from beta(cid:173)
`titanium to produce a sharper cutting edge that should provide for be.tter cutting or
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`..
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`a smooth finished surface. This includes instrumentation that will facilitate the
`cleaning and sealing of the root canal system. In addition, a coating or heat
`treatment may relieve stress in the instrument to allow it to withstand more torque,
`rotate through a larger angle of deflection, change the handling properties, or
`visually exhibit a near failure of the instrument. This aspect of the invention
`relates to all drills, burs, files, and instruments used in medicine and dentistry.
`[0019]
`In another aspect, the present invention provides for coating and/or
`heat-treating instruments including coatings to maintain and/or improve their
`sharpness, cutting ability, and/or instrument longevity and heat treatment(s) that
`improve their sharpness, cutting ability, and/or instrument longevity. Such an
`instrument may be manufactured from nickel-titanium, beta-titanium (as described
`
`above), stainless steel, carbide steel, as well as other materials. These
`instruments may be electropolished before or after coating or heat treating. These
`
`instruments will include medical, dental and endodontic instruments (both hand
`and engine driven), cutting burs (drills), and enlarging instruments including hand,
`
`mechanical and rotary.
`[0020]
`The coating processes may include the following processes: composite
`electroless plating (see, e.g., U.S. Patent Nos. 4,820,547; 4,997,686; 5, 145,517;
`
`5
`
`1 0
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`15
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`5,300,330; 5,863,616; and 6,306,466); chemical vapor deposition (see, e.g., U.S.
`Patent No. 4,814,294); microwave deposition (see, e.g., U.S. Patent No.
`
`20
`
`4,859,493); laser ablation process (see, e.g., U.S. Patent No. 5,299,937); ion
`beam assisted deposition (see, e.g., U.S. Patent No. 5,725,573); physical vapor
`deposition (see, e.g., U.S. Patent Nos. 4,670,024, 4,776,863, 4,984,940, and
`5,545,490); electropolishing; coatings including titanium nitride and titanium
`
`aluminum nitride commercially available under the trademark Firex™; coatings
`such as titanium nitride (TiN), titanium carbonitride (TiCN), titanium aluminum
`nitride (TiAIN), aluminum titanium nitride (AITiN); or multiple coatings or
`combinations of coatings.
`[0021]
`As detailed above, present medical and dental practice entails cutting of
`hard tissues such as bone or teeth with instruments manufactured of carbide
`steel, stainless steel and nickel-titanium. Present endodontic practice entails the
`preparation, cleaning, and shaping of root canals in teeth utilizing carbide steel,
`
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`5
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`10
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`15
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`20
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`25
`
`stainless steel and nickel-titanium. These can be manufactured as hand,
`mechanical and rotary instruments. Today a growing number of physicians and
`dentists (endodontists) are utilizing engine driven drills and files with various
`
`names and applications. This aspect of the present invention pertains to the
`application of coatings and/or heat treatment to cutting instruments such as drills
`and files to produce a sharper cutting edge and .a higher resistance to heat
`degradation that should provide for better cutting, a smooth surface and/or
`different metallurgical properties than the material from which it was
`manufactured. This includes instrumentation that will facilitate the cleaning and
`sealing of the root eanal system. In addition, a heat treatment separately applied
`
`or as utilized in the coating process may relieve stress in the instrument which
`should allow for more instrument longevity by the ability to withstand more torque,
`
`rotate through a larger angle of deflection, change the handling properties, or
`visually exhibit a near failure of the instrument. This aspect of the invention
`
`relates to all drills, burs, files, and instruments used in medicine and dentistry.
`[0022] One example process of this aspect of the present invention for such
`instruments is a titanium nitride coating. This coating process is done with
`physical vapor deposition with an inherent heat treatment. Another process is a
`
`multilayer process utilizing a titanium nitride coating and then a titanium aluminum
`nitride coating. This last coating process is commercially available under the
`trademark FIREX™.
`Another example process of this aspect of the present invention for
`[0023]
`such instruments is a metal or metal alloy coating incorporating particulate matter.
`One process to produce such a coating to an instrument includes contacting the
`surface of the instrument with a stable electroless metallizing bath comprising a
`metal salt, an electroless reducing agent, a complexing agent, an electroless
`plating stabilizer, a quantity of particulate matter which is essentially insoluble or
`sparingly soluble in the metallizing bath, and a particulate matter stabilizer, and
`maintaining the particulate matter in suspension in the metallizing bath during the
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`30
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`metallizing of the instrument for a time sufficient to produce a metallic coating with
`the particulate matter dispersed.
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`US ENDODONTICS, LLC., Petitioner
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`Although the present invention has been described in considerable
`
`[0024]
`detail with reference to certain embodiments, one skilled in the art will appreciate
`that the present invention can be practiced by other than the described
`embodiments, which have been presented for purposes of illustration and not of
`limitation. For example, while the present invention finds particular utility in the
`field of endodontic instruments, the invention is also useful in other medical and
`dental instruments used in creating or enlarging an opening. Therefore, the scope
`of the appended claims should not be limited to the description of the
`
`embodiments contained herein.
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`

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`What is claimed is:
`
`CLAIMS
`
`1.
`
`A dental or medical instrument for use in creating or enlarging an
`
`opening, the instrument comprising:
`an alloy of titanium that includes
`a stabilizing amount of a metal selected from the group consisting of
`molybdenum, columbium, tantalum, vanadium, zirconium, and niobium;
`a eutectoid beta stabilizer selected from the group consisting of
`
`chromium, cobalt, nickel, manganese or iron; and
`at least one metallic alpha stabilizer selected from the group
`
`consisting of aluminum and lanthanum.
`
`2.
`
`The instrument of claim 1 wherein the instrument is an endodontic
`
`instrument for use in performing root canal therapy on a tooth.
`
`3.
`
`A dental or medical instrument for use in creating or enlarging an
`
`opening, the instrument comprising:
`
`a substrate; and
`a coating on the substrate, the coating comprising a material selected from
`
`the group consisting of titanium nitride, titanium carbonitride, titanium aluminum
`nitride, aluminum titanium nitride, and mixtures thereof.
`
`4.
`
`The instrument-of claim 3 wherein the substrate comprises a
`
`material is selected from nickel-titanium, beta-titanium, stainless steel and carbide
`
`steel.
`
`The instrument of claim 4 wherein the instrument is an endodontic
`5.
`instrument for use in performing root canal therapy on a tooth.
`
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`10 of 16
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`IPR2015-00632 - Ex. 1011
`US ENDODONTICS, LLC., Petitioner
`
`

`

`A dental or medical instrument for use in creating or enlarging an
`6.
`opening, the instrument comprising:
`a nickel-titanium substrate; and
`a coating on the substrate, the coating comprising a material selected from
`the group consisting of titanium nitride, titanium carbonitride, titanium aluminum
`nitride, aluminum titanium nitride, and mixtures thereof.
`
`7.
`
`The instrument of claim 6 wherein the coating comprises titanium
`
`nitride and titanium aluminum nitride.
`
`8.
`The instrument of claim 6 wherein the instrument is an endodontic
`instrument for use in performing root canal therapy on a tooth.
`
`A dental or medical instrument for use in creating or enlarging an
`9.
`opening, the instrument comprising:
`a substrate; and
`
`a coating on the substrate, the coating comprising a metal or metal alloy
`incorporating particulate matter.
`
`The instrument of claim 9 wherein the substrate comprises a
`1 0.
`material selected from nickel-titanium, beta-titanium, stainless steel and carbide
`steel.
`
`The instrument of claim 9 wherein the instrument is an endodontic
`11.
`instrument for use in performing root canal therapy on a tooth.
`
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`IPR2015-00632 - Ex. 1011
`US ENDODONTICS, LLC., Petitioner
`
`

`

`A method for creating or enlarging an opening in a patient
`12.
`undergoing a medical or dental procedure, the method comprising:
`creating or enlarging the opening using an instrument comprising an alloy
`of titanium that includes
`
`a stabilizing amount of a metal selected from the group consisting of
`molybdenum, columbium, tantalum, vanadium, zirconium, and niobium;
`
`a eutectoid beta stabilizer selected from the group consisting of
`chromium, cobalt, nickel, manganese or iron; and
`
`at least one metallic alpha stabilizer selected from the group
`consisting of aluminum and lanthanum.
`
`13.
`
`The method of claim 12 wherein the procedure is root canal therapy.
`
`A method for creating or enlarging an opening in a patient
`14.
`undergoing a medical or dental procedure, the method comprising:
`
`creating or enlarging the opening using an instrument comprising
`a substrate; and
`a coating on the substrate, the coating comprising a material
`selected from the group consisting of titanium nitride, titanium carbonitride,
`titanium aluminum nitride, aluminum titanium nitride, and mixtures thereof.
`
`15.
`
`The method of claim 14 wherein the procedure is root canal therapy.
`
`A method for creating or enlarging an opening in a patient
`16.
`undergoing a medical or dental procedure, the method comprising:
`creating or enlarging the opening using an instrument comprising
`
`a nickel-titanium substrate; and
`a coating on the substrate, the coating comprising a material
`
`selected from the group consisting of titanium nitride, titanium carbonitride,
`titanium aluminum nitride, aluminum titanium nitride, and mixtures thereof.
`
`17.
`
`The method of claim 16 wherein the procedure is root canal therapy.
`
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`12 of 16
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`IPR2015-00632 - Ex. 1011
`US ENDODONTICS, LLC., Petitioner
`
`

`

`A method for creating or enlarging an opening in a patient
`18.
`undergoing a medical or dental procedure, the method comprising:
`
`creating or enlarging the opening using an instrument comprising
`a substrate; and
`
`a coating on the substrate, the coating comprising a metal or metal
`alloy incorporating particulate matter.
`
`19.
`
`The method of claim 18 wherein the procedure is root canal therapy.
`
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`13 of 16
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`IPR2015-00632 - Ex. 1011
`US ENDODONTICS, LLC., Petitioner
`
`

`

`ABSTRACT OF THE DISCLOSURE
`Medical and dental instruments, such as drills, burs and files, and
`endodontic instruments, such as drills, burs and files, used by dentists are
`described.
`
`5
`
`5586566v2
`
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`14 of 16
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`IPR2015-00632 - Ex. 1011
`US ENDODONTICS, LLC., Petitioner
`
`

`

`FIG. I
`
`26
`
`FIG.2
`
`c
`
`15 of 16
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`IPR2015-00632 - Ex. 1011
`US ENDODONTICS, LLC., Petitioner
`
`

`

`PATENT APPLICATION SERIAL NO . - - - - - - - -
`
`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`FEE RECORD SHEET
`
`06/10/2004 AADOF01 00000097 170055
`01 FC:2005
`80.00 DA
`
`60578091
`
`PT0-1556
`(5/87)
`
`·u.s. Government Prtnang Olllce: 2002- 488-2e7/e8033
`
`16 of 16
`
`IPR2015-00632 - Ex. 1011
`US ENDODONTICS, LLC., Petitioner
`
`