Filed on behalf of: Gold Standard Instruments, LLC
`
`By:
`
`
`
` Paper No. ____
`
`
`
`
`
`
`
` Date filed: November 19, 2015
`
`Joseph A. Hynds, Lead Counsel
`R. Elizabeth Brenner-Leifer, Back-up Counsel
`Jason M. Nolan, Back-up Counsel
`C. Nichole Gifford, Back-up Counsel
`Steven Lieberman, Pro Hac Vice (admission pending)
`Derek F. Dahlgren, Pro Hac Vice (admission pending)
`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
` ebrenner@rothwellfigg.com
` ngifford@rothwellfigg.com
` slieberman@rothwellfigg.com
` jnolan@rothwellfigg.com
` ddahlgren@rothwellfigg.com
`
`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 PRELIMINARY RESPONSE
`TO PETITION FOR POST-GRANT REVIEW
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`ii
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`TABLE OF CONTENTS
`
`III. 
`
`2. 
`
`TABLE OF AUTHORITIES ................................................................................... vi 
`TABLE OF ABBREVIATIONS ............................................................................. ix 
`EXHIBIT LIST ........................................................................................................ xi 
`I. 
`INTRODUCTION ........................................................................................... 1 
`II. 
`THE ʼ991 PATENT ......................................................................................... 3 
`A.  General Background of the ʼ991 Patent ............................................... 3 
`1. 
`How Endodontic Files are Used ................................................. 3 
`2. 
`Dr. Luebke’s Invention ............................................................... 6 
`Claims 12-16 ........................................................................................ 8 
`B. 
`Claim Construction ............................................................................ 12 
`C. 
`SPECIFIC REASONS WHY NO PGR SHOULD BE INSTITUTED ......... 16 
`A.  Ground 1 should Not be Instituted Because Petitioner has Not
`Presented a Prima Facie Case that the Claims are Not Enabled ....... 16 
`1. 
`Petitioner’s Argument that the Claims Contain
`Inoperable Embodiments is Insufficient as a Matter of
`Law ............................................................................................ 17 
`Petitioner has Not Conducted a Wands Analysis, Nor
`Established that any Experimentation would be Undue ........... 19 
`Ground 2 should Not be Instituted Because Petitioner has Not
`Presented a Prima Facie case that the Claims Lack Written
`Description Support ............................................................................ 25 
`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 Remaining Grounds should be Denied ................... 31 
`D.  Grounds 3 and 4 should Not be Instituted Because they Each Rely
`on Luebke 2008, which does Not Constitute Prior Art ...................... 31 
`Ground 5 should Not be Instituted Because it Relies on Matsutani,
`which does Not Constitute Prior Art under the Applicable Pre-
`AIA Provisions of 35 U.S.C. § 102 .................................................... 32 
`
`B. 
`
`C. 
`
`E. 
`
`iii
`
`

`
`F. 
`
`PGR2015-00019
`Patent 8,876,991
`
`b. 
`
`c. 
`
`Grounds 6-8 should Not be Instituted Because Petitioner has Not
`shown that the Claims are Either Prima Facie Anticipated by
`Kuhn under § 102, or Prima Facie Obvious under § 103 over
`Kuhn, Alone or in View of Heath or the 1992 ISO ........................... 33 
`1. 
`Kuhn Does Not Anticipate Claims 12-14 and 16 (Ground
`6) ............................................................................................... 34 
`a. 
`Kuhn does Not Teach or Suggest Making a
`Permanently Deformable File and does Not show
`the Specific Level of Deformation Required by the
`Claims ............................................................................ 34 
`Kuhn Nowhere Teaches or Suggests Heat-Treating
`the Entire Shank ............................................................. 36 
`None of Kuhn’s Heat-Treated Shank Pieces
`Demonstrate at Least 10 Degrees of Permanent
`Deformation in the ISO Test ......................................... 39 
`i. 
`Kuhn does not identify the bend test used ........... 39 
`ii. 
`Kuhn also explicitly states that the heat-
`treated shank pieces recovered their original
`shape ..................................................................... 41 
`The Figure 6A bending curves show heat-
`treated shanks that maintained their
`superelasticity ....................................................... 42 
`iv.  Kuhn’s 2001 companion article—which Dr.
`Goldberg never reviewed—confirms that the
`heat-treated shanks discussed in Kuhn are
`superelastic ........................................................... 45 
`The Fig. 4A DSC thermograms do not show
`that the heat-treated shanks would have at
`least 10 degrees of permanent deformation in
`the ISO Standard 3630-1 test ............................... 47 
`vi.  Kuhn affirmatively teaches that
`superelasticity of NiTi files is a good thing
`and thus expressly teaches away from the
`claimed invention ................................................. 51 
`
`iii. 
`
`v. 
`
`iv
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`2. 
`
`2. 
`
`3. 
`
`4. 
`
`3. 
`
`Kuhn, Either Alone or in Combination with Heath or the
`1992 ISO, Does Not Render Claim 15 Obvious (Ground
`7) ............................................................................................... 52 
`Kuhn, Either Alone or in Combination with Heath or the
`1992 ISO, Does Not Render Claims 12-16 Obvious
`(Ground 8) ................................................................................. 53 
`G.  Grounds 9 and 10 should Not be Instituted Because Petitioner has
`Not Shown that the Claims are Prima Facie Obvious under § 103
`over Pelton and McSpadden in View of Kuhn, Heath or the 1992
`ISO ...................................................................................................... 55 
`1.  McSpadden Seeks to Make a Stiffer NiTi file, Not a
`Permanently Deformable File ................................................... 57 
`Pelton Seeks to Optimize Superelasticity and Nowhere
`Teaches or Suggests Making a Permanently Deformable
`File ............................................................................................. 62 
`The Combination of McSpadden, Pelton, and Kuhn
`would Not Result in the Claimed Invention ............................. 63 
`Heath and the 1992 ISO Do Not Bridge the Gap Between
`Claim 15 and the Claimed Invention ........................................ 66 
`H.  Grounds 11 and 12 should Not be Instituted for the Same Reasons
`the Board Denied Institution of Petitioner’s Second Petition for
`IPR of the ’773 Patent ........................................................................ 68 
`1. 
`Grounds 11 and 12 should Not be Instituted Because they
`are Redundant to Grounds 9 and 10 .......................................... 68 
`Neither Tripi or McSpadden Teach or Disclose All of the
`Limitations of Claims 12-14 and 16 ......................................... 69 
`One of Skill in the Art Would Not Be Motivated to
`Combine Tripi with McSpadden to Make Softer,
`Deformable Files and Minimize or Remove
`Superelasticity ........................................................................... 73 
`Ground 12 Should Not Be Instituted Because Heath and
`the 1992 ISO Do Not Bridge the Critical Gaps Between
`the Tripi and McSpadden and the Claimed Invention .............. 75 
`IV.  CONCLUSION .............................................................................................. 76 
`
`2. 
`
`3. 
`
`4. 
`
`v
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`TABLE OF AUTHORITIES
`
`Cases 
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) ............................................................................ 26
`
`Capon v. Eshar,
`418 F.3d 1349 (Fed. Cir. 2005) ............................................................................ 17
`
`Cephalon, Inc. v. Watson Pharms., Inc.,
`707 F.3d 1330 (Fed. Cir. 2013) ..................................................................... 23, 24
`
`Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) ............................................................................ 61
`
`Ex Parte Jackson,
`217 U.S.P.Q.2d 804 (BPAI 1982) ........................................................................ 23
`
`In re Angstadt,
`537 F.2d 498 (CCPA 1976) ................................................................................. 17
`
`In re Berger,
`279 F.3d 975 (Fed. Cir. 2002) .............................................................................. 14
`
`In re Cook,
`439 F.2d 730 (CCPA 1971) ................................................................................. 18
`
`In re Corkill,
`771 F.2d 1496 (Fed. Cir. 1985) ............................................................................ 18
`
`In re Hilmer,
`359 F.2d 859 (CCPA 1966) ................................................................................. 33
`
`In re Rasmussen,
`650 F.2d 1212 (C.C.P.A. 1981) ........................................................................... 27
`
`In re Rosenberger,
`386 F.2d 1015 (C.C.P.A. 1967) ........................................................................... 60
`
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988) ........................................................... 19, 20, 22, 23
`
`vi
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) ...................................................................... 28, 29
`
`Innogenetics, N.V., v. Abbott Labs.,
`512 F.3d 1363 (Fed. Cir. 2008) ............................................................................ 75
`
`Johns Hopkins Univ. v. CellPro, Inc.,
`152 F.3d 1342 (Fed. Cir. 1998) ............................................................................ 23
`
`Liberty Mutual Inc. Co. v. Progressive Casualty Ins. Co.,
`CBM2012-00003, slip op. (PTAB Oct. 25, 2012) (Paper 8) ............................... 69
`
`LizardTech, Inc. v. Earth Res. Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) ............................................................................ 27
`
`Martek Biosciences Corp. v. Nutrinova, Inc.,
`579 F.3d 1363 (Fed. Cir. 2009) ............................................................................ 26
`
`Par Pharm., Inc. v. TWi Pharms., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) ............................................................................ 71
`
`Perfect Web Techs., Inc. v. Infousa, Inc.,
`587 F.3d 1324 (Fed. Cir. 2009) ............................................................................ 71
`
`PPG Indus. v. Guardian Indus. Corp.,
`75 F.3d 1558 (Fed. Cir. 1996) .............................................................................. 23
`
`Reiffin v. Microsoft Corp.,
`214 F.3d 1342 (Fed. Cir. 2000) ............................................................................ 26
`
`Tec Air, Inc. v. Denso Mfg. Mich. Inc.,
`192 F.3d 1353 (Fed. Cir. 1999) ............................................................................ 74
`
`Union Oil of Cal. v. Atl. Richfield Co.,
`208 F.3d 989 (Fed. Cir. 2000) .............................................................................. 30
`
`Wright Med. Tech., Inc. v. Orthophoenix, LLC,
`IPR2014-00912, slip op. (PTAB Dec. 16, 2014) (Paper 9) ................................. 74
`
`Statutes 
`
`35 U.S.C. § 102 ............................................................................................. 2, 32, 33
`
`vii
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`35 U.S.C. § 102(a)(2) ............................................................................................... 33
`
`35 U.S.C. § 102(d)(2)............................................................................................... 33
`
`35 U.S.C. § 103 ................................................................................................ passim
`
`35 U.S.C. § 112 ................................................................................................ passim
`
`35 U.S.C. § 120 ........................................................................................................ 13
`
`35 U.S.C. § 324(a) ..................................................................................................... 1
`
`35 U.S.C. § 325(d) ................................................................................................... 69
`
`Rules 
`
`37 C.F.R. § 42.207(a) ................................................................................................. 5
`
`37 C.F.R. § 42.208(a) ............................................................................................... 69
`
`37 C.F.R. § 42.208(c) ................................................................................................. 1
`
`37 C.F.R. § 42.65(a) ................................................................................................. 24
`
`37C.F.R. § 42.65(a) .................................................................................................. 24
`
`MPEP § 2164.08 ...................................................................................................... 17
`
`MPEP § 706.02(f)(1)................................................................................................ 33
`
`Regulations 
`
`Patent Trial Practice Guide,
`77 Fed. Reg. 48756 (Aug. 14, 2012) .................................................................... 34
`
`Legislative Materials 
`
`Leahy-Smith America Invents Act,
`Pub. L. No. 112-29, sec. 3(n)(1)(A), 6(f)(2) .......................................................... 1
`
`viii
`
`

`
`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
`
`
`
`
`Tripi
`
`Coltene
`
`DSC
`
`PVD
`
`NiTi
`
`Af
`
`
`As
`
`
`Mf
`
`
`Ms
`
`
`§ 102
`
`
`PGR2015-00019
`Patent 8,876,991
`
`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.
`107 (2000) (Ex. 1006)
`Tripi et al., 29 J. Endodontics 132 (2003) (Ex. 1032)
`Coltene/Whaledent, GmbH
`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
`
`ix
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`
`§ 103
`
`§ 112
`
`§ 120
`
`§ 324(a)
`
`§ 325(d)
`Rule 42.207(a)
`Rule 42.207(c)
`Rule 42.208(c)
`Rule 42.65(a)
`
`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)
`
`x
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`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).
`
`Ex. 2001
`
`
`Ex. 2002
`
`Ex. 2003
`
`
`Ex. 2007
`
`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. 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).
`
`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).
`
`xi
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`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 Jun. 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).
`
`xii
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`
`Ex. 2020
`
`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).
`
`xiii
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`I.
`
`INTRODUCTION
`
`Patent Owner, Gold Standard Instruments, LLC (“GSI”), respectfully
`
`requests that the Board deny Petitioner’s petition for PGR of claims 12-16 of
`
`the ʼ991 patent. The petition should be denied because the ʼ991 patent claims the
`
`benefit of, and is entitled to, the June 7, 2005 filing date of related PCT application
`
`PCT/US2005/019947 (the “2005 PCT”) and, thus, is ineligible for PGR. The ʼ991
`
`patent does not contain, and never contained, a claim with an effective filing date
`
`after June 7, 2005, much less March 16, 2013. See Leahy-Smith America Invents
`
`Act, Pub. L. No. 112-29, sec. 3(n)(1)(A), 6(f)(2). Therefore, because all the claims
`
`are entitled to the June 7, 2005 filing date, the ʼ991 patent is not eligible for PGR.
`
`Id. Furthermore, as described below, each of the twelve grounds in the petition
`
`should also be denied because Petitioner has not met its burden of proving that it is
`
`more likely than not that at least one of the challenged claims is unpatentable.
`
`See § 324(a); Rule 42.208(c).
`
`Grounds 1 and 2 should not be instituted because the patent specification
`
`meets the written description and enablement requirements of § 112. Petitioner has
`
`not presented a prima facie case that the patent does not demonstrate Dr. Luebke’s
`
`possession of the claimed inventions, or that one of ordinary skill could not make
`
`and use the claimed inventions based on the disclosure without undue
`
`experimentation. See Sections III(A) and (B). For the same reason, all the claims of
`
`1
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`the ʼ991 patent are entitled to at least the June 7, 2005 PCT filing date.
`
`Grounds 3 and 4 should not be instituted because they both rely on Luebke
`
`2008, which is not prior art. See Section III(D).
`
`Ground 5 should not be instituted because it relies on Matsutani, which
`
`does not constitute prior art under the applicable pre-AIA provisions of § 102. See
`
`Section III(E).
`
`Grounds 6-8 should not be instituted because Petitioner has not shown that
`
`the claims are either prima facie anticipated by Kuhn under § 102, or obvious
`
`under § 103 over Kuhn, alone or in view of Heath or the 1992 ISO.1 See Section
`
`III(F).
`
`Grounds 9 and 10 should not be instituted because Petitioner has not shown
`
`that claims 12-14 and 16 are prima facie obvious under § 103 over Pelton,
`
`McSpadden and Kuhn, or that claim 15 is prima facie obvious further in view of
`
`Heath or the 1992 ISO. See Section III(G).
`
`
`1 Petitioner refers to “ISO 3630-1” generally yet included parallel cites to two ISO
`
`Standards, one published in 1992 (“1992 ISO”; Ex. 1023) and one published in
`
`2008 (“2008 ISO”; Ex. 1014), as exhibits. Because the 2008 ISO is not prior art to
`
`the ʼ991 patent, GSI refers only to the 1992 ISO. However, GSI’s arguments
`
`would apply equally in the event the 2008 ISO applied.
`
`2
`
`

`
`PGR2015-00019
`Patent 8,876,991
`
`
`
`Grounds 11 and 12 should not be instituted for the same reasons the Board
`
`denied institution of Petitioner’s second petition for IPR of the ’773 patent—these
`
`grounds are redundant with grounds 9 and 10. Even if the Board determines these
`
`grounds are not redundant, they should not be instituted because Petitioner has not
`
`shown that claims 12-14 and 16 are prima facie obvious under § 103 over Tripi
`
`and McSpadden, or that claim 15 is prima facie obvious over those references
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`alone or further in view of Heath or the 1992 ISO. See Section III(H).
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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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`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 of the type described in the
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`prior art.
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`Prior to the 1990s, endodontic files were generally hand-held (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. The forces exerted against the canal by the
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`file can lead to mishaps known as zipping, ledging, transportation (or perforation),
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`and file separation (fracture). Ex. 1001, 2:17-23.
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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, 27-28.2 That is,
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`2 The exclusive licensees of the ʼ991 patent brought a patent infringement action
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`against Petitioner and moved for a preliminary injunction. This Preliminary
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`Response relies in part on testimony provided by Mr. Bennett (Petitioner’s Co-
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`founder), and Dr. Goldberg (Petitioner’s expert in both the litigation and in this
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`matter) in connection with a preliminary injunction hearing in the litigation. This
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`testimony constitutes admissions of a party opponent under Fed. R. Evid.
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`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. Superelasticity allows files to “spring back”
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`after being bent in a root canal. Id. at 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). Id., 28-29, 32.
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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. Ex. 2001, 33. When a
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`file breaks, a broken file piece often remains in the patient’s tooth. An endodontist
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`801(d)(2). The Preliminary Response also relies in part on the prior declarations
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`and testimony of Dr. Luebke (the inventor) and Dr. Sinclair (the exclusive
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`licensees’ expert in the litigation and an earlier IPR proceeding). All of this
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`testimony is properly considered by the Board under Rule 42.207(a) since it does
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`not constitute “new testimony evidence” under Rule 42.207(c). The preliminary
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`injunction motion is currently sub judice.
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`or dentist then must try to remove the broken file piece. Id., 33-36. While
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`superelastic NiTi reduced the frequency of ledging, perforation, and other
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`problems encountered with stainless steel files, those problems still occurred with
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`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 better navigates the root canal and solved the
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`fracture problem seen with superelastic NiTi files. Ex. 1001, 2:59–3:5.
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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 NiTi files. Ex. 2001, 19-20, 38. Dr. Luebke first considered making a
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`sharper file, evaluating both a diamond coating and a titanium-nitride coating. Id.,
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`38-39. He made titanium-nitride-coated files by heat-treating machined
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`superelastic NiTi files in nitrogen gas and titanium. Id., 39, 141; Ex. 2004, 108-
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`113; Ex. 2005.
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`Then Dr. Luebke heat-treated machined files without those coatings and had
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`a “eureka” moment. Ex. 2001, 39-44. Dr. Luebke found that heat-treatment
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`lessened 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-heat-treated superelastic NiTi files. Id.;
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`Ex. 1001, 8:37-63. Dr. Luebke’s post-machined heat-treated NiTi files exhibited
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`greater than 10 degrees of permanent deformation when tested in accordance with
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`the ISO Standard 3630-1 bend test, whereas non-heat-treated superelastic files
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`demonstrated only a de minimis amount of permanent deformation after this test.
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`Ex. 1001, Fig. 6, 8:37-63. Unlike the prior art NiTi files, Dr. Luebke’s invention
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`resulted in a softer, more deformable file, which allowed it to navigate the root
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`canal’s curvature without damaging the tooth. Ex. 2001, 40-41. Also, this reduced
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`the occurrence of file fracture, zipping, ledging, and perforation.
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`After he filed the 2005 PCT, Dr. Luebke attempted to market his invention
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`to endodontic manufacturers. Id., 42-58. The conventional wisdom at that time was
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`that NiTi’s superelasticity was advantageous and that a soft, permanently
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`deformable file, like that created by Dr. Luebke’s inventive process, was neither
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`desirable nor suitable. Ex. 2002, 105. For years, Dr. Luebke’s invention was met
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`with skepticism by others in the industry. Ex. 2001, 41-44, 58. Dr. Luebke met
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`with several different companies. Id., 58. Finally, in 2014, Dr. Luebke’s company,
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`GSI, licensed his patents to Dentsply International Inc. and its subsidiary, Tulsa
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`Dental Products LLC (collectively “Dentsply”). Id. Dentsply manufactures and
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`sells a post-machined heat-treated NiTi file called the Vortex Blue® that is made
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`by the patented method and has enjoyed commercial success. Ex. 2006, ¶ 9.
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`Once files made using Dr. Luebke’s post-machined heat treatment process
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`were introduced, the industry recognized the benefits, and many practitioners
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`switched over to these softer files. Several other companies have since copied
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`Dr. Luebke’s invention, including Petitioner, its sister company Edge Endo, and
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`Coltene. These companies now sell heat-treated NiTi rotary files. Ex. 2001, 59, 76.
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`In fact, Mr. Bobby Bennett, Petitioner’s Chief Operating Officer, testified that he
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`was told by his co-owner, Dr. Goodis, that the “primary purpose” of heat treating
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`the machined files that are accused of infringing the related ’773 patent was to
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`make a product that could “actually compete in the marketplace.” Ex. 2002, 174.
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`Indeed, Petitioner has testified that heat treatment resulted in “superior” files, and
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`Petitioner’s sister company Edge Endo advertises the files made using claimed heat
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`treatment process as being “revolutionary.” Ex. 2002, 172; Ex. 2008, 60; Ex. 2007.
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`B. Claims 12-16
`The ʼ991 patent relates to a method of heat-treating a machined superelastic
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`NiTi endodontic instrument (e.g., a file) whereby the entire shank of the instrument
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`is heat-treated to cause the shank to lose its superelastic properties and become
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`permanently deformable when bent. Ex. 1001. The claims require that the heat
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`treatmen