Paper No. ____
`
` Date filed: May 6, 2016
`
`Joseph A. Hynds, Lead Counsel
`Steven Lieberman, Pro Hac Vice
`R. Elizabeth Brenner-Leifer, Back-up Counsel
`C. Nichole Gifford, Back-up Counsel
`Derek F. Dahlgren, Pro Hac Vice
`Jason M. Nolan, Back-up Counsel
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040; Facsimile: 202-783-6031
`Emails: jhynds@rothwellfigg.com
` slieberman@rothwellfigg.com
` ebrenner@rothwellfigg.com
` ngifford@rothwellfigg.com
` ddahlgren@rothwellfigg.com
` jnolan@rothwellfigg.com
`
`Filed on behalf of: Gold Standard Instruments, LLC
`
`By:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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 PGR2015-00019
`Patent 8,876,991 B2
`_______________
`
`PATENT OWNER’S RESPONSE
`TO PETITION FOR POST-GRANT REVIEW
`
`

`
`TABLE OF CONTENTS
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`TABLE OF AUTHORITIES ................................................................................... iv 
`TABLE OF ABBREVIATIONS ............................................................................. vi 
`EXHIBIT LIST ...................................................................................................... viii 
`I. 
`INTRODUCTION ........................................................................................... 1 
`II. 
`THE ʼ991 PATENT ......................................................................................... 6 
`A.  General Background of the ʼ991 Patent ............................................... 6 
`1. 
`How Endodontic Files are Used ................................................. 6 
`2. 
`Dr. Luebke’s Invention ............................................................. 11 
`Claims 12-16 ...................................................................................... 14 
`B. 
`III.  Claim Construction ........................................................................................ 16 
`IV.  Claims 12-16 Are Enabled By The ʼ991 Patent And Earlier Related
`Applications ................................................................................................... 17 
`A. 
`Petitioner’s Argument that the Claims Contain Inoperable
`Embodiments is Wrong and is Insufficient as a Matter of Law ........ 17 
`Petitioner has Not Established that any Experimentation
`would be Undue .................................................................................. 24 
`Claims 12-16 of the ʼ991 Patent Have Adequate Written Description
`Support ........................................................................................................... 33 
`VI.  Because All of the Challenged Patent Claims are Entitled to an
`Effective Filing Date of June 7, 2005, the ’991 Patent is Ineligible
`for PGR and the Review Should be Terminated ........................................... 39 
`VII.  As Demonstrated Above, Claims 12-16 are Entitled to at Least the June
`7, 2005 PCT Filing Date and Therefore Luebke 2008 does Not
`Constitute Prior Art........................................................................................ 40 
`VIII.  Kuhn Does not Anticipate Claims 12-14 or 16, Nor Does it Render
`Claim 15 Obvious Either Alone or in View of Heath or the 1992 ISO ........ 41 
`A.  Kuhn Does Not Anticipate Claims 12-14 or 16 ................................. 41 
`1. 
`Kuhn States that the File Specimens Recovered
`Their Original State after Bending, which was
`Confirmed by Patent Owner’s Experiments .................. 41 
`
`V. 
`
`B. 
`
`ii
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`None of Kuhn’s Heat-Treated Shank Pieces
`Demonstrate at Least 10 Degrees of Permanent
`Deformation in the ISO Test ......................................... 45 
`i. 
`Kuhn does not identify the bend test used ........... 45 
`ii. 
`Kuhn Discloses Annealing Heat Treatments,
`Which Further Supports the Statement that
`the heat-treated shank pieces recovered their
`original shape ....................................................... 48 
`iii.  Kuhn’s 2001 companion article—which Dr.
`Goldberg never reviewed—confirms that the
`heat-treated specimens discussed in Kuhn are
`superelastic ........................................................... 50 
`The Fig. 4A DSC thermograms do not show
`that the heat-treated specimens would have at
`least 10 degrees of permanent deformation in
`the ISO Standard 3630-1 test ............................... 51 
`Kuhn, Either Alone or in Combination with Heath or the 1992
`ISO, Does Not Render Claim 15 Obvious (Ground 7) ...................... 57 
`IX.  CONCLUSION .............................................................................................. 58 
`
`iv. 
`
`2. 
`
`B. 
`
`iii
`
`

`
`TABLE OF AUTHORITIES
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`Cases 
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) ..................................................................... 35, 39
`
`Capon v. Eshar,
`418 F.3d 1349 (Fed. Cir. 2005) ............................................................................ 20
`
`Cephalon, Inc. v. Watson Pharms., Inc.,
`707 F.3d 1330 (Fed. Cir. 2013) ..................................................................... 26, 28
`
`Ex Parte Jackson,
`217 U.S.P.Q.2d 804 (B.P.A.I. 1982) .................................................................... 26
`
`In re Angstadt,
`537 F.2d 498 (C.C.P.A. 1976) ............................................................................. 19
`
`In re Cook,
`439 F.2d 730 (C.C.P.A. 1971) ............................................................................. 20
`
`In re Corkill,
`771 F.2d 1496 (Fed. Cir. 1985) ............................................................................ 20
`
`In re Rasmussen,
`650 F.2d 1212 (C.C.P.A. 1981) ........................................................................... 35
`
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988) ...................................................................... passim
`
`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) ...................................................................... 36, 37
`
`Johns Hopkins Univ. v. CellPro, Inc.,
`152 F.3d 1342 (Fed. Cir. 1998) ............................................................................ 26
`
`LizardTech, Inc. v. Earth Res. Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) ............................................................................ 35
`
`Martek Biosciences Corp. v. Nutrinova, Inc.,
`579 F.3d 1363 (Fed. Cir. 2009) ............................................................................ 35
`
`iv
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) .............................................................................. 5
`
`PPG Indus. v. Guardian Indus. Corp.,
`75 F.3d 1558 (Fed. Cir. 1996) .............................................................................. 26
`
`Reiffin v. Microsoft Corp.,
`214 F.3d 1342 (Fed. Cir. 2000) ............................................................................ 34
`
`Union Oil of Cal. v. Atl. Richfield Co.,
`208 F.3d 989 (Fed. Cir. 2000) ....................................................................... 38, 39
`
`Statutes 
`
`35 U.S.C. § 102 .......................................................................................................... 1
`
`35 U.S.C. § 103 .......................................................................................................... 1
`
`35 U.S.C. § 112(a) ..................................................................................................... 1
`
`Other Authorities 
`
`37 C.F.R. § 42.65(a) ................................................................................................. 29
`
`MPEP § 2164.08 ...................................................................................................... 20
`
`MPEP § 2164.08(b).................................................................................................. 20
`
`
`
`v
`
`

`
`Patent Owner
`Petitioner
`
`GSI
`
`
`Edge Endo
`Pet.
`
`
`Board
`
`PTO
`
`PGR
`
`IPR
`
`
`’632 IPR
`
`’991 patent
`ʼ773 patent
`AIA
`
`
`MPEP
`
`ISO
`
`
`1992 ISO
`
`2008 ISO
`Luebke 2008
`Heath
`
`Kuhn
`
`Kuhn 2001
`Matsutani
`
`McSpadden
`Pelton
`
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`TABLE OF ABBREVIATIONS
`
`Gold Standard Instruments, LLC
`US Endodontics, LLC
`Gold Standard Instruments, LLC
`Edge Endo, LLC
`Petition for Post-Grant Review
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`Post-Grant Review
`Inter Partes Review
`IPR2015-00632, US Endodontics, LLC v. Gold Standard
`Instruments, LLC
`U.S. Patent 8,876,991 (Ex. 1001)
`U.S. Patent 8,727,773 (Ex. 1011)
`Leahy-Smith America Invents Act, Public Law 112-29 (Sept.
`16, 2011)
`Manual of Patent Examination Procedure
`International Organization for Standardization
`International Standard ISO 3630-1 (1st ed. 1992) (Ex. 1023)
`International Standard ISO 3630-1 (2d ed. 2008) Ex. 1014)
`U.S. Patent App. Pub. 2008/0032260 A1 (Ex. 1012)
`U.S. Patent 5,628,674 (Ex. 1024)
`Kuhn et al., 28 J. Endodontics 716 (2002) (Ex. 1030)
`Kuhn et al., 27 J. Endodontics 516 (2001) (Ex. 2017)
`Japanese Patent App. Pub. No. 2006-0115786 (Ex. 1025)
`U.S. Patent App. Pub. No. 2002/0137008 A1 (Ex. 1031)
`Pelton et al., 9 Minimally Invasive Therapies and Allied Techs.
`
`vi
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`
`
`
`Tripi
`
`DSC
`
`PVD
`
`NiTi
`Af
`
`
`As
`
`
`Mf
`
`
`Ms
`
`
`
`§ 102
`
`§ 103
`
`§ 112
`
`§ 120
`
`§ 324(a)
`
`§ 325(d)
`Rule 42.207(a)
`Rule 42.207(c)
`Rule 42.208(c)
`Rule 42.65(a)
`
`107 (2000) (Ex. 1006)
`Tripi et al., 29 J. Endodontics 132 (2003) (Ex. 1032)
`differential scanning calorimetry
`physical vapor deposition
`nickel titanium
`austenite finish temperature
`austenite start temperature
`martensite finish temperature
`martensite start temperature
`35 U.S.C. § 102
`35 U.S.C. § 103
`35 U.S.C. § 112
`35 U.S.C. § 120
`35 U.S.C. § 324(a)
`35 U.S.C. § 325(d)
`37 C.F.R. § 42.207(a)
`37 C.F.R. § 42.207(c)
`37 C.F.R. § 42.208(c)
`37 C.F.R. § 42.65(a)
`
`vii
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`EXHIBIT LIST
`
`Preliminary Injunction Hearing Transcript, Vol. I (public version),
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, (E.D. Tenn. Nov.
`25, 2014).
`
`Preliminary Injunction Hearing Transcript, Vol. II, Dentsply Int’l Inc.
`and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental Specialties v.
`US Endodontics, LLC, No. 2:14-196, (E.D. Tenn. Nov. 26, 2014).
`
`PCT application publication WO 2005/122942 (filed June 7, 2005),
`Neill H. Luebke.
`
`Ex. 2001
`
`
`Ex. 2002
`
`
`Ex. 2003
`
`
`Ex. 2004 Deposition Transcript of Neill H. Luebke, D.D.S., M.S. (redacted),
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, (E.D. Tenn. Oct. 8,
`2014); and errata sheet (E.D. Tenn. Nov. 12, 2014).
`
`
`Ex. 2005 Guhring, Inc., Guhring Coating Services, 2003.
`
`Ex. 2006 Declaration of John Voskuil, Dentsply Int’l Inc. and Tulsa Dental
`Prods. LLC d/b/a/ Tulsa Dental Specialties v. US Endodontics, LLC,
`No. 2:14-196, (E.D. Tenn. July 9, 2014).
`
`
`Ex. 2007
`
`Edge Endo, LLC’s product information for the EdgeFile (Oct. 30,
`2014), printed from <http://edgeendo.com/products/edgefile/>.
`
`
`Ex. 2008 US Endodontics, LLC’s Counter-Designations to Plaintiffs’
`Designations of Bobby Bennett Deposition Testimony and Redacted
`Public Version of the Designated Transcript, Dentsply Int’l Inc. and
`Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental Specialties v. US
`Endodontics, LLC, No. 2:14-196, (E.D. Tenn. Dec. 12, 2014), pp. 1,
`29-32, 36, 58-61, 65, 67, 68, 71, 79, 80, 93, 98, 99, 145, 149, 150,
`187, 195, 196, 200, 221-224, and 229.
`
`
`Ex. 2009
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,727,773,
`US Endodontics, LLC v. Gold Standard Instruments, LLC, IPR2015-
`00632, (Jan. 30, 2015) (Paper 2).
`
`viii
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`Ex. 2010 Declaration of A. Jon Goldberg, Ph.D., US Endodontics, LLC v. Gold
`Standard Instruments, LLC, IPR2015-00632, (Jan. 30, 2015) (Ex.
`1002).
`
`
`Ex. 2011
`
`PowerPoint slides presented by Petitioner’s Expert Dr. Jeffrey Stec,
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, (E.D. Tenn. Nov.
`26, 2014).
`
`
`Ex. 2012 US Endodontics, LLC v. Gold Standard Instruments, LLC, IPR2015-
`00632, Decision - Institution of Inter Partes Review - 37 CFR
`§ 42.108 (PTAB Aug. 5, 2015) (Paper 29).
`
`
`Ex. 2013
`
`Petitioner’s Motion to Submit Supplemental Information Pursuant to
`37 C.F.R. § 42.123(a), US Endodontics, LLC v. Gold Standard
`Instruments, LLC, IPR2015-00632, (Aug. 28, 2015) (Paper 37).
`
`
`Ex. 2014 Deposition Transcript of A. Jon Goldberg, Ph.D., Dentsply Int’l Inc.
`and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental Specialties v.
`US Endodontics, LLC, No. 2:14-196, (E.D. Tenn. Sept. 30, 2014).
`
`
`Ex. 2015 U.S. Patent No. 5,843,244 (filed June 13, 1966).
`
`Ex. 2016
`
`Petitioner’s Request for Partial Rehearing of the Board’s Decision
`Instituting Inter Partes Review, US Endodontics, LLC v. Gold
`Standard Instruments, LLC, IPR2015-00632, (Aug. 19, 2015) (Paper
`32).
`
`
`Ex. 2017 Kuhn et al., “Influence of Structure on Nickel-Titanium Endodontic
`Instruments Failure,” Journal of Endodontics, 27(8), 516-20 (Aug.
`2001).
`
`
`Ex. 2018 ASTM International, F2004-05 (2010), Standard Test Method for
`Transformation Temperature of Nickel-Titanium Alloys by Thermal
`Analysis.
`
`
`Ex. 2019
`
`
`
`Expert Report of Robert Sinclair, Ph.D., Dentsply Int’l Inc. and Tulsa
`Dental Prods. LLC d/b/a/ Tulsa Dental Specialties v. US Endodontics,
`LLC, No. 2:14-196, (E.D. Tenn. Sept. 12, 2014).
`
`ix
`
`

`
`Ex. 2020
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`Petition for Inter Partes Review of U.S. Patent No. 8,727,773,
`US Endodontics, LLC v. Gold Standard Instruments, LLC, IPR2015-
`01476, (June 25, 2015) (Paper 1).
`
`
`Ex. 2021 US Endodontics, LLC v. Gold Standard Instruments, LLC, IPR2015-
`00632, Decision - Petitioner’s Request for Rehearing - 37 CFR
`§ 42.108, (PTAB Sept. 29, 2015) (Paper 41).
`
`
`Ex. 2022 US Endodontics, LLC v. Gold Standard Instruments, LLC, IPR2015-
`01476, Denying Institution of Inter Partes Review, 35 U.S.C.
`§ 325(d) and 37 CFR § 42.108, (PTAB Oct. 26, 2015) (Paper 13).
`
`
`Ex. 2023
`
`
`Ex. 2024
`
`
`Ex. 2025
`
`
`Ex. 2026
`
`
`Ex. 2027
`
`
`
`x
`
`Patent Owner Gold Standard Instruments, LLC's Notice of Cross-
`Examination of Walter Zanes, filed on April 6, 2016.
`
`Patent Owner Gold Standard Instruments, LLC's Notice of Cross-
`Examination of Adam Kozak, filed on April 6, 2016.
`
`ISO 3630-1, “Dentistry - Root-canal instruments - Part 1: General
`requirements and test methods,” International Organization for
`Standardization, Second Edition (Feb. 1, 2008).
`
`
`ISO 3630-1, “Dental root-canal instruments - Part 1: Files, reamers,
`barbed broaches, rasps, paste carriers, explorers and cotton
`broaches,” International Organization for Standardization, First
`Edition (Dec. 15, 1992).
`
`ISO/CD 3630-1, “Dentistry - Root-canal instruments - Part 1:
`General requirements,” International Organization for
`Standardization, First Edition (June 30, 2004).
`
`EXHIBIT NUMBER NOT USED
`
`EXHIBIT NUMBER NOT USED
`
`
`Ex. 2028
`
`Ex. 2029
`
`Ex. 2030 U.S. Patent No. 7,967,605 (filed June 28, 2011).
`
`Ex. 2031 U.S. Provisional Patent Application Serial No. 61/263,192, filed on
`Nov. 11, 2009.
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`Ex. 2032 U.S. Patent Application Publication No. 2002/0137008.
`
`Ex. 2033
`
`Franklin S. Weine, ENDODONTIC THERAPY, 6th Ed., 2004, Chapter 5
`(“Weine”).
`
`File History for U.S. Patent Application Serial No. 14/522,013.
`
`
`Ex. 2034
`
`Ex. 2035 Kowalski Heat Treating Company Certification, date Jan. 15, 2016.
`
`Ex. 2036 KMT ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing
`Final Report, dated Jan 18, 2016.
`
`
`Ex. 2037
`
`
`Ex. 2038
`
`Thompson, S.A., An Overview of Nickel-Titanium Alloys Used in
`Dentistry, Int’l Endodontic Journal, 33, 297-310 (2000).
`
`Email communications between Dr. Neill H. Luebke and Bobby
`Bennett, dated June 27, 2010 and July 6, 2010.
`
`
`Ex. 2039 Goldberg Deposition Transcript, taken on April 20, 2016.
`
`Ex. 2040
`
`Ex. 2041 Kozak Deposition Transcript, taken on April 13, 2016.
`
`Ex. 2042
`
`Zanes Deposition Transcript, taken on April 11, 2016.
`
`Lopez et al., “Bending characteristics of nitinol wire,” Am. J. Orthod.,
`75(5):569-575 (May 1979).
`
`xi
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`Based on a preliminary record, the Board instituted post-grant review of the
`
`ʼ991 patent on six grounds: (i) claims 1-12 under § 112(a) for alleged lack of
`
`enablement; (ii) claims 12-16 under § 112(a) for alleged lack of written description
`
`support; (iii) claims 12-16 under § 102 based on Luebke 2008; (iv) claim 15 under
`
`§ 103 over Luebke 2008 alone or in view of Heath or ISO 3630-1; (v) claims 12-14
`
`and 16 under § 102 based on Kuhn; and (vi) claim 15 under § 103 over Kuhn alone
`
`or in view of Heath or ISO 3630-1. Pursuant to Rule 42.220, Patent Owner, Gold
`
`Standard Instruments, LLC (“GSI”), submits this Patent Owner Response.
`
`I.
`
`INTRODUCTION
`
`Claims 12-16 of the ʼ991 patent are directed to a method of heat treating a
`
`superelastic NiTi endodontic instrument (e.g., a file), whereby the entire shank is
`
`heat-treated to minimize its superelastic properties and make the shank more
`
`flexible and permanently deformable. Ex. 1001. To this end, claims 12-16 of the
`
`ʼ991 patent expressly require that the entire shank of the endodontic instrument be
`
`heated and that the heat treatment result in a shank that will exhibit greater than 10
`
`degrees of permanent deformation after torque at 45 degrees of flexion when tested
`
`in accordance with ISO 3630-1. In its Institution Decision, the Board correctly held
`
`that the “wherein” clause, which sets forth the permanent deformation requirement,
`
`is a material limitation:
`
`the “wherein” clause provides a means of assessing the efficacy of the
`act of heat-treating a shank to determine if the resulting physical
`
`1
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`transformation of the shank places the heat treating process within the
`scope of claim 12.
`
`Paper 17 at 23. Thus, as the Board concluded, the claimed heat treatment process is
`
`limited to those that result in a shank which will exhibit greater than 10 degrees of
`
`permanent deformation when tested according to ISO 3630-1. Any heat treatments
`
`that do not result in such a file are not within the scope of the claims.
`
`Dr. Neill Luebke, the inventor of the ’991 patent and a practicing
`
`endodontist, was the first person to heat-treat the entire shank of a superelastic
`
`NiTi file for this purpose. The conventional wisdom at the time of Dr. Luebke’s
`
`invention was that NiTi’s superelasticity was advantageous and that softer files
`
`such as those that result from Dr. Luebke’s innovative process would not work. Ex.
`
`2030, 9:50-53 (“Thus, in a preferred embodiment, the nitinol is configured to be
`
`the austenite phase, and to thereby exhibit maximum shape memory and elasticity,
`
`when operated within a human body . . . .”)1; Ex. 2031, ¶17 (“This property of
`
`NiTi and other similar alloys is sometimes referred to in part as superelasticity or
`
`pseudoelasticity and is often lauded as a unique and beneficial characteristic of
`
`
`1 Ex. 2030 is a patent naming Dr. Charles Goodis as an inventor. Dr. Goodis is also
`
`named as one of Petitioner’s real parties in interest and thus the statements in his
`
`patent constitute admissions of a party opponent under Fed. R. Evid. 801(d)(2).
`
`2
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`endodontic files made from NiTi.”) 2; cf. Ex. 2032, ¶43 (“Another significant
`
`drawback is reduced manipulation control due to reduced stiffness and extreme
`
`torsional flexibility of presently available NiTi endodontic files as compared with
`
`stainless steel files.”); Ex. 2033, 211(“When flexible files were used in an attempt
`
`to traverse such canals, many would buckle, just like a wet noodle, particularly
`
`when the small sizes (nos. 08 and 10) were used.”). Dr. Luebke discovered not
`
`only that the conventional wisdom was wrong, but that his process resulted in a
`
`superior file. Indeed, Dr. Luebke’s deformable files exhibit two major
`
`improvements over prior art files: (1) they fracture less often during use; and (2)
`
`they better negotiate the root canal without damaging the tooth. Ex. 1001 at 9:19-
`
`30.
`
`The Board instituted post-grant review based, in part, on alleged lack of
`
`enablement and written description. Regarding enablement, the Board
`
`preliminarily held that Petitioner had shown that temperatures allegedly recited in
`
`the claimed range did not provide the requisite amount of permanent deformation
`
`after being subjected to the ISO 3630-1 bend test, and that this demonstrated there
`
`2 Ex. 2031 is a provisional patent application naming Mr. Bobby Bennett as an
`
`inventor. Mr. Bennett is also named as one of Petitioner’s real parties in interest
`
`and thus the statements in his patent constitute admissions of a party opponent
`
`under Fed. R. Evid. 801(d)(2).
`
`3
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`was not a “generally operable invention.” Paper 17 at 19. Regarding written
`
`description, the Board preliminarily held that the ʼ991 patent did not demonstrate
`
`that Dr. Luebke was in possession of a method for heating a file at all temperatures
`
`above 25ºC that result in the claimed permanent deformation. Id. at 26.
`
`The Board’s preliminary decisions were based on an incorrect interpretation
`
`of the claims and relied on Petitioner’s and Dr. Goldberg’s blinkered view of the
`
`knowledge of a person of skill in the art. As explained below, the alleged
`
`inoperative embodiments are not within the scope of claims 12-16. See infra pp.
`
`17-19.
`
`Further, in a related proceeding Dr. Goldberg has contradicted his testimony
`
`in this proceeding that undue experimentation would be needed to practice the
`
`claims, and he also admitted during cross examination that he was not sure whether
`
`the volume of testing would be undue. See infra pp. 27-29.
`
`Moreover, during the prosecution of a related patent, Dr. Luebke submitted
`
`information to the Patent Office demonstrating that a heat-treatment at 300ºC
`
`resulted in a file that satisfies the permanent deformation limitation of the
`
`“wherein” clause. Ex. 2034, 43-64. See infra pp. 23-24 below. The results
`
`submitted by Dr. Luebke stand in stark contrast to the testing submitted by
`
`Petitioner and relied on by the Board in the preliminary Institution Decision.
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`For each of these reasons, Petitioner’s enablement and written description
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`challenges fall short.
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`For the same reasons, the ʼ991 patent is entitled to at least the June 7, 2005
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`filing date and does not qualify for post-grant review. Here, Petitioner concedes
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`that the 2005 PCT application contains essentially the same disclosure as the ʼ991
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`patent. Those disclosures provide support for claims 12-16 of the ʼ991 patent. For
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`that reason, the Board should resolve the present review with a final decision in
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`Patent Owner’s favor. Additionally, for the same reasons, Luebke 2008 does not
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`qualify as prior art and therefore cannot anticipate claims 12-16.
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`Finally, Petitioner’s prior art challenge based on Kuhn also fails on the
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`merits. Dr. Luebke discovered a particular problem with a characteristic that had
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`generally been accepted as a beneficial property of nickel titanium files:
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`superelasticity. Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1377 (Fed. Cir.
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`2012) (“Often the inventive contribution lies in defining the problem in a new
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`revelatory way.”). Dr. Luebke created a process for minimizing the superelasticity
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`of NiTi files.
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`That is not what Kuhn accomplished. Indeed, to demonstrate that the
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`annealing process described in Kuhn would not result in files that satisfy the
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`permanent deformation limitation of the ‘991 patent, Patent Owner replicated the
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`process described by Kuhn and heated the same file specimens as set forth in
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`Kuhn. Ex. 2035; Ex. 2036. After heating, these files were tested according to the
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`ISO 3630-1 bend test and they did not exhibit greater than 10 degrees of permanent
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`deformation as required by the claims of the ʼ991 patent. Ex. 2036, p. 7. Rather,
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`the files behaved superelastically. Id. This is consistent with Kuhn’s own statement
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`in the article itself that the files returned to their original state after being bent.
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`Tellingly, Petitioner has presented no evidence that the process disclosed in Kuhn
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`results in a permanently deformable file that would satisfy the “wherein” clause
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`aside from Dr. Goldberg’s conclusory statements. Regardless, as shown by Patent
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`Owner, Kuhn does not disclose or suggest a permanently deformable file, and
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`neither Heath nor the 1992 ISO 3630-1 cure that deficiency.
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`
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`For the foregoing reasons, and as set forth in more detail below, Petitioner
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`has failed to meet its burden to prove unpatentability by a preponderance of the
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`evidence and the Board should confirm that patentability of claims 12-16.
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`II. THE ʼ991 PATENT
`A. General Background of the ʼ991 Patent
`1.
`How Endodontic Files are Used
`Endodontics is the branch of dentistry concerned with disease of the soft
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`
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`inner tissue of the tooth, known as pulp, which is made up of nerves, blood, and
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`connective tissue. During a root canal (endodontic therapy), the diseased or
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`decayed material is removed, then the canal is shaped, filled with an inert material,
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`and sealed in order to preserve the tooth. To remove the pulp and shape the root
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`canal, an endodontist uses a small instrument known as an endodontic file. The
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`graphic below generally depicts an endodontic file (hand file) of the type described
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`in the prior art.
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`.
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`Prior to the 1990s, endodontic files were generally hand-held (i.e., manually
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`operated) files made of stainless steel. One of the challenges faced by endodontists
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`is that a significant number of the root canals are naturally curved, making it
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`difficult for the endodontist to navigate a long, curved canal with a straight
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`endodontic file. Ex. 1001, 1:63–2:23. As shown in the figure below, the forces
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`exerted against the canal by the file can lead to mishaps known as ledging (2),
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`zipping (3), or transportation (or perforation) (4), and file separation (i.e., fracture).
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`Ex. 1001, 2:17-23.
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`These problems are real and significant. File failure, or failure during the root canal
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`procedure (e.g., transportation) can result in the loss of the tooth.
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`
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`In the early 1990s, superelastic nickel titanium (“NiTi”) succeeded stainless
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`steel as the material of choice for endodontic files because of its balance of
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`flexibility and strength as compared to stainless steel. Ex. 2001, 27:23-28:2.3 That
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`is, NiTi was sufficiently strong for use as an endodontic file, while being more
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`flexible than stainless steel but not to the point of feeling like a “wet noodle.”
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`Endodontists also preferred NiTi’s superelastic behavior, which was viewed as a
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`benefit over prior stainless steel files. Ex. 2030, 9:33-55; Ex. 2031, ¶17 (“This
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`property of NiTi and other similar alloys is sometimes referred to in part as
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`superelasticity or pseudoelasticity and is often lauded as a unique and beneficial
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`characteristic of endodontic files made from NiTi.”). Indeed, an article from 2000
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`stated
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`The super-elastic behavior of Nitinol wires means that on unloading
`they return to their original shape following deformation. These
`properties are of interest in endodontology as they allow construction
`of root canal instruments that utilize these favourable characteristics
`to provide an advantage when preparing curved canals.
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`3 The exclusive licensees of the ʼ991 patent brought a patent infringement action
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`against Petitioner and moved for a preliminary injunction based on related patents.
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`This Patent Owner Response relies in part on testimony provided by Mr. Bennett
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`(Petitioner’s Co-founder), and Dr. Goldberg (Petitioner’s expert in both the
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`litigation and in this matter) in connection with a preliminary injunction hearing in
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`the litigation. This testimony constitutes admissions of a party opponent under Fed.
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`R. Evid. 801(d)(2).
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`...
`As the alloy has greater strength and a lower modulus of elasticity
`compared with stainless steel . . . there may be an advantage in the use
`of NiTi instruments during the preparation of curved root canals,
`because the files will not be permanently deformed as easily as would
`happen with traditional alloys.
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`Ex. 2037, 297. As stated above, superelasticity allows files to “spring back” after
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`being bent in a root canal. Ex. 2001, 15, 30, 249. The availability of superelastic
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`NiTi also led to the use of endodontic rotary files (i.e., electric drills known as
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`dental handpieces). Ex. 2001, 28-29, 32.
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`
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`Although superelastic NiTi files, when introduced in the early 1990s, were
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`viewed as an improvement over the earlier stainless steel hand files, endodontists
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`recognized at the time that the superelastic NiTi rotary files had a tendency to
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`fracture during use due to the lateral stresses placed on the file (particularly when
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`used in a rotary hand piece) in a tooth’s curved root canal. When a file breaks, a
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`broken file piece often remains in the patient’s tooth. An endodontist or dentist
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`then must try to remove the broken file piece. While superelastic NiTi reduced the
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`frequency of ledging, perforation, and other problems encountered with stainless
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`steel files, those problems still occurred with the superelastic NiTi rotary files.
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`For a period of more than 10 years, the industry tried to fix this problem in
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`many ways—without success. For example, the dental industry increased the size
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`and taper of the file, but this failed to solve the problem. Larger files also created
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`another problem because they removed more tooth structure, compromising the
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`tooth. The ’991 patent is directed to a process for making an improved, post-
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`machined heat-treated NiTi file that minimizes its superelastic properties, resulting
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`in a more flexible, deformable file that better navigates the root canal and solved
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`the fracture problem seen with superelastic NiTi files. Ex. 1001, 2:59–3:5. This
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`was contrary to the conventional wisdom at the time that superelasticity was a
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`desirable property and that softer files, such as those resulting from Dr. Luebke’s
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`invention, would not work.
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`Dr. Luebke’s Invention
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`2.
`Starting in 1995, Dr. Luebke—then a practicing endodontist—recognized
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`these problems and spent substantial time and personal funds researching how to
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`improve superelastic NiTi files. Dr. Luebke first considered making a sharper file,
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`evaluating both a diamond coating and a titanium-nitride (TiN) coating. He made
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`TiN coated files by heat-treating machined superelastic NiTi files in nitrogen gas
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`and titanium. Ex. 2001, 39, 141; Ex. 2004, 108-113; Ex. 2005. Dr. Luebke
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`conducted experiments on those files and was pleased with the results, recognizing
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`that his files had improved properties over conventional, superelastic NiTi files and
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`that they were capable of being deformed, i.e., they no longer behaved
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`superelastically. Dr. Luebke was concerned, however, that the coating might flake
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`off and cause complications during root canal procedures.
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`Next, Dr. Luebke heat-treated machined files without those coatings.
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`Ex. 2001, 39-44. Dr. Luebke found that heat-treatment without the coatings further
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`decreased the NiTi’s superelasticity, making the files softer and more easily
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`deformable. Id. at 40-41. The heat-treated NiTi files stayed bent, instead of
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`springing back like conventional, non-he