Filed on behalf of: Gold Standard Instruments, LLC
`
`By:
`
`
`
`
`
`Joseph A. Hynds, Lead Counsel
`R. Elizabeth Brenner-Leifer, Back-up Counsel
`Jason M. Nolan, Back-up Counsel
`Steven Lieberman, Pro Hac Vice
` Derek F. Dahlgren, Pro Hac Vice
` 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
` 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 IPR2015-01476
`Patent 8,727,773 B2
`_______________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`TO PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`
`
` Paper No. ____
`
` Date filed: July 30, 2015
`
`
`
`
`
`
`
`
`
`

`
`Case IPR2015-01476
`Patent 8,727,773
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`

`
`Case IPR2015-01476
`Patent 8,727,773
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES .................................................................................... ii 
`TABLE OF ABBREVIATIONS ............................................................................. vi 
`EXHIBIT LIST ....................................................................................................... vii 
`I. 
`INTRODUCTION ........................................................................................... 1 
`II. 
`THE ʼ773 PATENT ......................................................................................... 3 
`A. 
`The patent claims. .................................................................................. 3 
`B. 
`Background ........................................................................................... 5 
`C. 
`Claim Construction ............................................................................. 10 
`1. 
`“Heat-treating” and “heat-treated” ............................................ 10 
`2. 
`The “permanent deformation” wherein clause. ........................ 10 
`PETITIONER’S ARGUMENT THAT THE ʼ773 PATENT CLAIMS
`ARE NOT ENTITLED TO THE FILING DATE OF
`PCT/US2005/019947 IS AN IMPROPER REPLY TO SUPPORT ITS
`FIRST IPR PETITION AND, MOREOVER, IS WRONG. ......................... 18 
`IV.  GROUNDS 1 AND 2 ARE WITHOUT MERIT AND SHOULD NOT
`BE INSTITUTED .......................................................................................... 21 
`A. 
`Legal standards for obviousness ......................................................... 21 
`B. 
`Ground 1 (Endo, in combination with Tripi and McSpadden)
`should not be instituted. ...................................................................... 24 
`Ground 2 (Endo, in combination with Tripi, McSpadden, and the
`1992 ISO) should not be instituted. ..................................................... 31 
`Petitioner fails to explain why grounds 1 and 2 are not redundant
`with grounds raised in its first IPR petition. ....................................... 31 
`CONCLUSION .............................................................................................. 33 
`
`III. 
`
`V. 
`
`C. 
`
`D. 
`
`i
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`Case IPR2015-01476
`Patent 8,727,773
`
`TABLE OF AUTHORITIES
`
`
`Cases 
`
`AIA Eng’g Ltd. v. Magotteaux Int’l S/A,
`657 F.3d 1264 (Fed. Cir. 2011) ............................................................................ 16
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) ..................................................................... 20, 21
`
`Berk-Tek LLC v. Belden Techs Inc.,
`IPR2013-00057, slip op. (PTAB May 14, 2013) (Paper 21) ................................. 3
`
`Butamax Advanced Biofuels LLC v. Gevo, Inc.,
`IPR2014-00581, slip op. (PTAB Oct. 14, 2014) (Paper 8) .................................. 33
`
`Circuit Check Inc. v. QXQ, Inc.,
`C.A. No. 2015-115, slip op. (Fed. Cir. July 28, 2015) ............................. 2, 22, 25
`
`Dawson v. Dawson,
`Interference No. 105,719, slip op. (BPAI Nov. 25, 2011) (Paper 196), aff’d-in-
`part, 710 F.3d 1347 (Fed. Cir. 2013) ................................................................... 16
`
`Falkner v. Inglis,
`448 F.3d 1357 (Fed. Cir. 2006) ............................................................................ 19
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................................. 21
`
`Griffin v. Bertina,
`285 F.3d 1029 (Fed. Cir. 2002) ............................................................................ 17
`
`Heart Failure Techs., LLC v. Cardiokinetix, Inc.,
`IPR2013-00183, slip op. (PTAB July 31, 2013) (Paper 12) ................................ 22
`
`Hoffer v. Microsoft Corp.,
`405 F.3d 1326 (Fed. Cir. 2005) ............................................................................ 17
`
`In re Berger,
`279 F.3d 975 (Fed. Cir. 2002) .............................................................................. 14
`
`ii
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`Case IPR2015-01476
`Patent 8,727,773
`
`In re Clay,
`966 F.2d 656 (Fed. Cir. 1992) .............................................................................. 25
`
`In re Cuozzo Speed Techs., LLC.,
`778 F.3d 1271 (Fed. Cir. 2015) ............................................................................ 10
`
`In re Gurley,
`27 F.3d 551 (Fed. Cir. 1994) ................................................................................ 23
`
`Innogenetics, N.V., v. Abbott Labs.,
`512 F.3d 1363 (Fed. Cir. 2008) ............................................................................ 31
`
`InTouch Techs., Inc. v. VGo Commc’ns.,
`751 F.3d 1327 (Fed. Cir. 2014) ............................................................................ 24
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 22, 23
`
`LG Elecs., Inc. v. Cypress Semiconductor Corp.,
`IPR 2014-01343, slip op. (PTAB Feb. 9, 2015) (Paper 7) .................................. 10
`
`Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co.,
`CBM2012-00003, slip op. (PTAB Oct. 25, 2012) (Paper 7) ........................ 32, 33
`
`LizardTech, Inc. v. Earth Res. Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) ............................................................... 19, 20, 21
`
`Minton v. NASD, Inc.,
`336 F.3d 1373 (Fed. Cir. 2003) ..................................................................... 16, 17
`
`Oracle Corp. v. Clouding IP, LLC,
`IPR2013-00088, slip op. (PTAB June 13, 2013) (Paper 13) ............................... 32
`
`Par Pharm., Inc. v. TWi Pharms., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) ............................................................................ 27
`
`Parks v. Fine,
`773 F.2d 1577 (Fed. Cir. 1985) ............................................................................ 15
`
`Perfect Web Techs., Inc. v. Infousa, Inc.,
`587 F.3d 1324 (Fed. Cir. 2009) ..................................................................... 28, 29
`
`iii
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`Case IPR2015-01476
`Patent 8,727,773
`
`Samsung Elecs. Co. v. Surpass Tech Innovation LLC,
`PR2015-00885, slip op. (PTAB July 6, 2015) (Paper 7) ................................ 1, 18
`
`Tec Air, Inc. v. Denso Mfg. Mich. Inc.,
`192 F.3d 1353 (Fed. Cir. 1999) ............................................................................ 30
`
`U.S. v. Adams,
`383 U.S. 39 (1966) ............................................................................................... 22
`
`Veeam Software Corp. v. Symantec Corp.,
`IPR2013-00145, slip op. (PTAB Aug. 7, 2013) (Paper 12) ................................ 22
`
`W.L. Gore & Assocs., Inc. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983) ............................................................................ 23
`
`Wang Labs., Inc. v. Toshiba Corp.,
`993 F.2d 858 (Fed. Cir. 1993) ................................................................................ 3
`
`Wowza Media Sys., LLC v. Adobe Sys. Inc.,
`IPR2013-00054, slip op. (PTAB Apr. 8, 2013) (Paper 12) ................................. 22
`
`Wright Medical Tech., Inc. v. Orthophoenix, LLC,
`IPR2014-00912, slip op. (PTAB Dec. 16, 2014) (Paper 9) ................................. 29
`
`Statutes 
`
`35 U.S.C. § 103 ................................................................................................... 2, 24
`
`35 U.S.C. § 112 ................................................................................................... 1, 19
`
`35 U.S.C. § 314(a) ..................................................................................................... 3
`
`35 U.S.C. § 325(d) ............................................................................................ 31, 33
`
`Other Authorities 
`
`37 C.F.R. § 42.1 ....................................................................................................... 33
`
`37 C.F.R. § 42.100(b) .............................................................................................. 10
`
`37 C.F.R. § 42.107(a) ................................................................................................. 5
`
`37 C.F.R. § 42.108 ................................................................................................... 31
`
`iv
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`

`
`37 C.F.R. § 42.12(a)(7) ............................................................................. 1, 2, 11, 19
`
`37 C.F.R. § 42.20(c) ................................................................................................... 3
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`v
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`Case IPR2015-01476
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`TABLE OF ABBREVIATIONS
`
` Gold Standard Instruments, LLC
`Patent Owner
` US Endodontics, LLC
`Petitioner
`
` Edge Endo, LLC
`Edge Endo
` Guidance Endodontics, LLC
`Guidance
`
` Petition for Inter Partes Review
`Pet.
`
`
`
` Patent Trial and Appeal Board
`Board
`
`
` United States Patent and Trademark Office
`PTO
`
`
`Inter Partes Review
`
`IPR
`
`
`
` U.S. Patent 8,727,773 (Ex. 1101)
`ʼ773 patent
`
`International Standard ISO 3630-1 (1st ed. 1992) (Ex. 1113)
`1992 ISO
`
` Endo et al., 13 Dental Materials Journal 228 (1994) (Ex. 1108)
`Endo
`
`
` Kuhn et al., 28 J. Endodontics 716 (2002) (Ex. 2021)
`Kuhn
`
`
` U.S. Patent App. Pub. No. 2002/0137008 A1 (Ex. 1111)
`McSpadden
` Tripi et al., 29 J. Endodontics 132 (2003) (Ex. 1110)
`Tripi
`
`
` Pelton et al., 9 Minimally Invasive Therapies and Allied Techs.
`Pelton
`
`
`
`107 (2000) (Ex. 2022)
`
`
`
`
`
`
`35 U.S.C. § 103
`§ 103
`
`
`
`35 U.S.C. § 112
`§ 112
`
`
`
`35 U.S.C. § 314(a)
`§ 314(a)
`
`
`35 U.S.C. § 325(d)
`§ 325(d)
`
`
`37 C.F.R. § 42.1
`Rule 42.1
`
`Rule 42.12(a)(7) 37 C.F.R. § 42.12(a)(7)
`Rule 42.12(b)(3) 37 C.F.R. § 42.12(b)(3)
`Rule 42.20(c)
`
`37 C.F.R. § 42.20(c)
`Rule 42.100(b)
`37 C.F.R. § 42.100(b)
`Rule 42.107(a))
`37 C.F.R. § 42.107(a)
`Rule 42.108
`
`37 C.F.R. § 42.108
`
`vi
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`EXHIBIT LIST
`Ex. 2001 Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Preliminary
`Injunction Hearing Transcript, Volume I, dated Nov. 25, 2014 (E.D.
`Tenn.), pp. 1, 2, 11, 12, 15, 19, 20, 27-30, 32-59, 76-78, 141, 243,
`249, and 301 (index).
`Ex. 2002 Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Preliminary
`Injunction Hearing Transcript, Volume II, dated Nov. 26, 2014 (E.D.
`Tenn.), pp. 1, 2, 51, 104, 105, 129, 159, 172-74, and 197 (index).
`Exhibit number not used.
`Ex. 2003
`Ex. 2004 Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Deposition
`Transcript of Neill H. Luebke, dated Oct. 8, 2014 (E.D. Tenn.), pp. 1
`and 108-113.
`Ex. 2005 U.S. Patent No. 4,850,867 (filed Feb. 5, 1988), Figure 2 and column
`3.
`Ex. 2006 Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Declaration of
`John Voskuil, filed July 9, 2014 (E.D. Tenn.).
`Prosecution history of Edge Endo, LLC’s U.S. Trademark Reg. No.
`4,638,335 (as of May 5, 2015), pages showing attorney of record and
`owner.
`Exhibit number not used.
`Exhibit number not used.
`Exhibit number not used.
`Exhibit number not used.
`Edge Endo, LLC’s product information for the EdgeFile (Oct. 30,
`2014), printed from <http://edgeendo.com/products/edgefile/>.
`Exhibit number not used.
`Ex. 2013
`Ex. 2014 Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, US Endodontics,
`LLC’s Counter-Designations to Plaintiffs’ Designations of Bobby
`
`Ex. 2008
`Ex. 2009
`Ex. 2010
`Ex. 2011
`Ex. 2012
`
`Ex. 2007
`
`vii
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`Ex. 2015
`Ex. 2016
`Ex. 2017
`
`Bennett Deposition Testimony and Redacted Public Version of the
`Designated Transcript, dated Dec. 12, 2014 (E.D. Tenn.), pp. 1, 60,
`98, and 99.
`Exhibit number not used.
`Exhibit number not used.
`Edge Endo, LLC’s testing study for the EdgeFile (Apr. 14, 2014),
`printed from <http://edgeendo.com/resources/testing/>.
`Exhibit number not used.
`Ex. 2018
`Ex. 2019 Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Plaintiff’s Motion
`for a Preliminary Injunction, filed July 9, 2014 (E.D. Tenn.).
`Ex. 2020 Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Defendant’s
`Preliminary Injunction Hearing Demonstratives by Dr. Jeffery A.
`Stec, Nov. 26, 2014 (E.D. Tenn.), pp. 1 and 8.
`Ex. 2021 Kuhn et al., 28 J. Endodontics 716 (2002).
`Ex. 2022 Pelton et al., 9 Minimally Invasive Therapies and Allied Techs.
`107 (2000).
`Ex. 2023 US Endodontics, LLC v. Gold Standard Instruments, LLC, IPR2015-
`00632, Petition For Inter Partes Review (PTAB Jan. 30, 2015) (Paper
`2), pp. 16, 32.
`Exhibit number not used.
`Ex. 2024
`Ex. 2025 Guhring, Inc., Guhring Coating Services 2003.
`
`viii
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`I.
`
`INTRODUCTION
`This is the second petition for Inter Partes Review of U.S. Patent 8,727,773
`
`(the ’773 patent) filed by US Endodontics, LLC. As discussed below, the two
`
`grounds raised in this second IPR petition are without merit and seem to be merely
`
`a pretense for Petitioner to file an improper reply to Patent Owner’s Preliminary
`
`Response to Petitioner’s first IPR petition. For example, although the references
`
`upon which Petitioner relies in this second petition predate the PCT application to
`
`which the ’773 patent claims priority, Petitioner devotes the first five pages of this
`
`petition trying to buttress the arguments in its first petition that the PCT application
`
`does not provide § 112 written description support for the patent claims and that
`
`the claims are invalid over intervening art. Pet. 1-5, 8, 17-18. Petitioner’s improper
`
`reply arguments have no place in this second petition. Petitioner is abusing the IPR
`
`process by filing this second petition in order to file improper reply arguments in
`
`support of its first petition. Rule 42.12(a)(7); Samsung Elecs. Co. v. Surpass Tech
`
`Innovation LLC, IPR2015-00885, slip op. at 3 (PTAB July 6, 2015) (Paper 7)
`
`(“Generally, a petitioner is not authorized to file a reply to a patent owner
`
`preliminary response.”). See Section III.
`
`As another example, Petitioner argued in its first petition that the Board
`
`should read the “greater than 10 degrees of permanent deformation in the ISO
`
`3630-1 test” limitation out of the patent claims. Pet. 1. As discussed in Patent
`
`1
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`Owner’s preliminary response to that first petition, this clause constitutes a
`
`material limitation of the claimed method. In its second petition, Petitioner seeks to
`
`further supplement its argument by relying upon additional prosecution history that
`
`it could have discussed in its first petition, but did not. Its new arguments
`
`constitute an unauthorized and thus improper reply brief. See Rule 42.12(a)(7);
`
`Rule 42.12(b)(3). In any case, the additional prosecution history upon which
`
`Petitioner relies supports Patent Owner’s position, not Petitioner’s. See Section
`
`II.C.
`
`As will be discussed in Section IV, grounds 1 and 2 of this second petition
`
`are without merit and should not be instituted. The two new references upon which
`
`Petitioner relies under § 103 are even further afield than the references upon which
`
`it relied in its first petition. Petitioner’s primary reference, Endo, is not even
`
`analogous art—it relates to biocompatible surgical implants, not endodontic
`
`instruments. Endo is not in the same field of endeavor and it is not pertinent to the
`
`fracture problem Dr. Luebke was trying to solve. Indeed, Petitioner’s declarant
`
`offers no opinion at all on the references, let alone that Endo constitutes analogous
`
`art. Petitioner has thus failed to establish that Endo constitutes prior art for an
`
`obviousness analysis, and its obviousness case fails for this reason alone. Circuit
`
`Check Inc. v. QXQ, Inc., C.A. No. 2015-115, slip op. at 6 (Fed. Cir. July 28, 2015)
`
`(“To be considered within the prior art for purposes of the obviousness analysis, a
`
`2
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`Case IPR2015-01476
`Patent 8,727,773
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`reference must be analogous.”); Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858,
`
`864 (Fed. Cir. 1993) (same). Moreover, even if Endo did constitute prior art,
`
`Petitioner still has not met its burden of proving in its second petition a reasonable
`
`likelihood that it would prevail with respect to any of the claims. Petitioner’s
`
`assertion that a person of ordinary skill would have found the claims obvious
`
`constitutes nothing more than unsupported, hindsight-driven attorney argument.
`
`Petitioner also has not explained why these grounds are not redundant with
`
`grounds raised in its first petition. See § 314(a); Rule 42.20(c); Berk-Tek LLC v.
`
`Belden Tech.s Inc., IPR2013-00057, slip op. at 3 (PTAB May 14, 2013) (Paper
`
`21). See Section IV.
`
`II. THE ʼ773 PATENT1
`A. The patent claims.
`The ʼ773 patent relates to a method of heat-treating a superelastic nickel
`
`titanium endodontic instrument, e.g., a file, whereby the entire instrument shank is
`
`heat-treated to cause the shank to lose its superelastic properties and become
`
`permanently deformable when bent. Ex. 1101. The claims require that the heat
`
`
`1 Patent Owner is obliged to repeat portions of its Preliminary Response to
`
`Petitioner’s first IPR petition in order to provide the Board with a complete
`
`response to Petitioner’s second petition.
`
`3
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`treatment be sufficient to produce a shank that exhibits greater than 10 degrees of
`
`permanent deformation when tested in accordance with the bend test for dental
`
`root canal instruments set forth in International Standard ISO 3630-1. The resulting
`
`shank exhibits two major improvements over the prior art shanks: (1) it fractures
`
`less often during use; and (2) it better negotiates the root canal without damaging
`
`the tooth. Id. at 9:19-30.
`
`Independent claim 1 reads as follows:
`
`A method for manufacturing or modifying an endodontic
`
`instrument for use in performing root canal therapy on a tooth, the
`
`method comprising:
`
`(a) providing an elongate shank having a cutting edge extending
`
`from a distal end of the shank along an axial length of the shank, the
`
`shank comprising a superelastic nickel titanium alloy, and
`
`(b) after step (a), heat-treating the entire shank at a temperature
`
`from 400 °C. up to but not equal to the melting point of the
`
`superelastic nickel titanium alloy,
`
`wherein the heat treated shank has an angle greater than 10
`
`degrees of permanent deformation after torque at 45 degrees of
`
`flexion when tested in accordance with ISO Standard 3630-1.
`
`4
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`Dependent claims 4 and 5 specify the atmosphere for the heat treatment
`
`(unreactive, ambient, or any other acceptable heat treatment process). Dependent
`
`claim 8 requires a 0.5-1.6 mm diameter instrument. Dependent claim 9 requires
`
`heat treatment at a single temperature. And dependent claim 12 requires that the
`
`superelastic nickel titanium alloy be composed of 54-57% nickel and 43-46%
`
`titanium (by weight).
`
`Background
`
`B.
`Prior to the 1990s, endodontic hand files generally were made from stainless
`
`steel. Superelastic nickel titanium succeeded stainless steel as the material of
`
`choice for endodontic files in the early 1990s because of its increased flexibility
`
`and strength as compared to stainless steel. Ex. 2001, 27-28.2 Due to its
`
`superelasticity, a conventional nickel titanium file springs back to its original shape
`
`
`2 The exclusive licensees of the ʼ773 patent brought a patent infringement action
`
`against Petitioner in the United States District Court for the Eastern District of
`
`Tennessee, and moved for a preliminary injunction against Petitioner. This
`
`Preliminary Response relies in part on court testimony provided on November 25-
`
`26, 2014, as well as deposition testimony provided earlier. This testimony is
`
`properly considered by the Board under Rule 42.107(a). The preliminary
`
`injunction motion is still under consideration.
`
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`when bent. Id. at 15, 30, 249. The availability of superelastic nickel titanium also
`
`led to the development of the first endodontic rotary files (i.e., electric drills known
`
`as dental handpieces). Id. at 28-29, 32.
`
`Although superelastic nickel titanium files became commonly used,
`
`endodontists widely recognized that such files had a tendency to fracture during
`
`use, due to the lateral stresses placed on the files when rotated (particularly when
`
`used in a rotary handpiece) in a tooth’s curved root canal. Id. at 33. When a file
`
`breaks, a broken file piece often remains in the patient’s tooth. An endodontist or
`
`dentist then must try to remove the broken file piece. Id. at 33-36.
`
`The industry attempted to address this fracture problem by increasing file
`
`size and taper, but this did not solve the fracture problem. Ex. 2001, 36. Not only
`
`that, a larger diameter file removes more tooth structure during the root canal
`
`procedure, which compromises the integrity of the tooth. Id. Superelastic nickel
`
`titanium rotary files also damage the tooth by causing problems known as zipping,
`
`ledging, and perforation—problems that were also encountered with prior art
`
`stainless steel hand files. Id. at 37.
`
`
`
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`zipping
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ledging
`
`
`
`
`
`
`
`Ex. 2005, Fig. 2, 3:53-68.
`
`Dr. Neill Luebke, then a practicing, board-certified endodontist, recognized
`
`these problems and, beginning in 1995, spent substantial time and personal funds
`
`researching how to improve nickel titanium files. Ex. 2001, 19-20, 38. Dr. Luebke
`
`initially considered making a sharper file, evaluating both a diamond coating and a
`
`titanium-nitride coating. Id. at 38-39. He made titanium-nitride-coated files by
`
`heat-treating superelastic nickel titanium files in nitrogen gas and titanium. Id. at
`
`39, 141; Ex. 2004. He then tried heat-treating files without any coating. Ex. 2001,
`
`39-44. Dr. Luebke found that heat treatment made the files more flexible and less
`
`likely to fracture during use. Id. at 40-41. He also found that heat treatment
`
`lessened the nickel titanium’s superelasticity, making the files softer and more
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`easily deformable. Id. at 40. His heat-treated files stayed bent, instead of springing
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`back like conventional, non-heat-treated superelastic nickel titanium files do. Ex.
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`1101, 8:34-59. Dr. Luebke’s heat-treated nickel titanium files maintained greater
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`than 10 degrees of permanent deformation when tested in accordance with the ISO
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`bend test, whereas non-heat-treated superelastic files demonstrated only a de
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`minimis amount of permanent deformation. Id. at Fig. 6. Unlike the prior art nickel
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`titanium files, Dr. Luebke’s invention results in a more flexible file, which allows
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`the file to rotate in the root canal without damaging the tooth. Ex. 2001, 40-41.
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`Dr. Luebke applied for a patent in 2004. After he filed his application, Dr.
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`Luebke attempted to market his invention to several endodontic companies. Id. at
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`42-58. The conventional wisdom at that time was that nickel titanium’s
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`superelasticity was advantageous and that a soft, permanently deformable file, like
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`that created by Dr. Luebke’s inventive process, was neither desirable nor suitable.
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`Ex. 2002, 105. Dr. Luebke’s invention was initially met with skepticism. He was
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`repeatedly told that the files were too soft. Ex. 2001, 41-42.
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`Four years passed before any of the companies that Dr. Luebke had
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`approached expressed interest in Dr. Luebke’s invention. Then, in 2008, Coltene-
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`Whaledent, a dental supply company, contacted Dr. Luebke about his invention.
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`Ex. 2001, 43-44. Under the terms of a secrecy agreement, Dr. Luebke met with
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`Coltene representatives twice and also provided them with a sample heat-treated
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`file. Id. at 43. After negotiations with Coltene ended without a license, Dr. Luebke
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`talked to a number of different companies about his invention. Id. at 58. Finally, in
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`2013, Dentsply International Inc. and its subsidiary, Tulsa Dental Products LLC
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`(collectively “Dentsply”) “pulled the trigger” and exclusively licensed Dr.
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`Luebke’s patents. Id. Dentsply’s Vortex Blue®, a heat-treated file made by a
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`process covered by the ’773 patent claims, has enjoyed commercial success. Ex.
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`2006, ¶ 9. Indeed, a number of other companies have since copied Dr. Luebke’s
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`invention, including Petitioner, Petitioner’s sister company and distributor—Edge
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`Endo, and Coltene. All of these companies now sell heat-treated nickel titanium
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`rotary files. Ex. 2001, 59, 76.
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`Petitioner performs no research or development of its own. Ex. 2002, 159.
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`Petitioner only began heat-treating files at the request of its owner, Dr. Charles
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`Goodis, who also owns Edge Endo. Ex. 2007, 3. Dr. Goodis and Edge Endo are
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`real parties in interest to this petition. Dr. Goodis’ interest in heat-treating nickel
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`titanium files “was to have a product that he could actually compete in the
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`marketplace with.” Ex. 2002, 174. Petitioner testified that heat treatment resulted
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`in “superior” files. Ex. 2002, 172; Ex. 2014, 60. Petitioner’s files are marketed by
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`Edge Endo as lower-cost substitutes for the nickel titanium endodontic rotary files
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`offered by Patent Owner Gold Standard Instruments, LLC’s exclusive licensee,
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`Dentsply, and two other market leaders—Sybron and Brasseler. Ex. 2006, ¶¶ 14-
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`15; Ex. 2012, 1-2; Ex. 2017, 2; Ex. 2019, ¶ 8. Petitioner’s files are specifically
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`marketed as having precisely the same advantage that Dr. Luebke found resulted
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`from his patented heat-treatment process. Ex. 2012, 1 (“A broken file is… one of
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`the worst things that can happen during a procedure. Our revolutionary heat treated
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`Fire-Wire™ NiTi yields performance enhancing durability....”).
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`C. Claim Construction
`The claims at issue must be construed in accordance with the broadest
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`reasonable interpretation standard. Rule 42.100(b); In re Cuozzo Speed Techs.,
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`LLC., 778 F.3d 1271, 1282 (Fed. Cir. 2015). “Under the broadest reasonable
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`construction standard, claim terms are given their ordinary and customary
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`meaning, as would be understood by one of ordinary skill in the art in the context
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`of the entire disclosure.” LG Elecs., Inc. v. Cypress Semiconductor Corp.,
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`IPR2014-01343, slip op. at 5 (PTAB Feb. 9, 2015) (Paper 7).
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`“Heat-treating” and “heat-treated”
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`1.
`The parties agree that the broadest reasonable interpretation of the terms
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`“heat-treating” (see claim 1) and “heat-treated” (see claims 1 and 9) is atmosphere-
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`neutral and includes heat treatment in any atmosphere. Pet. 9-10. Limiting “heat-
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`treating” to an unreactive atmosphere—as Petitioner (incorrectly) argued in the
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`related district court litigation—would conflict with dependent claims 4-6, which
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`explicitly encompass heat treatment in an ambient atmosphere. Id.; Ex. 1101.
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`The “permanent deformation” wherein clause.
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`2.
`A quarter of Petitioner’s second petition constitutes an improper reply to
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`support an argument that Petitioner made in its first petition—that the Board
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`should read out of independent claim 1 the “wherein” clause that requires that the
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`heat-treated shank have greater than 10 degrees of permanent deformation in the
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`ISO Standard 3630-1 best test, or rewrite the claim limitation to require only
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`“some degree” of permanent deformation. Pet. 10-16. Petitioner relies upon
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`additional prosecution history that it could have discussed in its first petition, and
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`its arguments should be disregarded as improper. Rule 42.12(a)(7); Rule
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`42.12(b)(3).
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`The Board also should reject Petitioner’s arguments because this clause
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`constitutes a material limitation of the claimed method. It requires that the heat-
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`treatment step be sufficient to transform the nickel titanium alloy from a
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`superelastic material (see claim step 1(a)) to a permanently deformable material
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`that exhibits greater than 10 degrees of permanent deformation after testing in the
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`ISO Standard 3630-1 bend test. Petitioner’s request to read this limitation out of
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`the claims, or to redefine “10 degrees” as “some degrees,” constitutes nothing
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`more than a transparent attempt to overcome the fact that none of the references
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`upon which Petitioner relies to show invalidity (in either its first or its second IPR
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`petition) teaches or suggests these limitations.
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`The “greater than 10 degrees of permanent deformation” wherein clause
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`relates back to and modifies the heat-treating steps in claim 1. In claim 1, step (b)
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`requires: “heat-treating the entire shank at a temperature from 400 °C. up to but not
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`equal to the melting point of the superelastic nickel titanium alloy.” The express
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`language in claim 1 requires that the heat treatment performed in step (b) decrease
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`the superelasticity of the instrument shank and produce a shank that exhibits
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`greater than 10 degrees of permanent deformation after testing in the ISO Standard
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`3630-1 bend test.
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`As was also the case in its first IPR petition, Petitioner’s argument
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`mistakenly presupposes that heat-treating a superelastic nickel titanium shank (step
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`(b)) will always produce a shank that exhibits greater than 10 degrees of permanent
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`deformation after testing in the ISO Standard 3630-1 bend test. Pet. 11 (“[T]he
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`claims merely state that if a particular test is performed on the shank after the
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`claimed method is performed, a certain range of results will be achieved.... The
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`‘wherein’ clause merely recites the result of a known or obvious process.”)
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`(emphasis added). Petitioner provides no factual basis for this incorrect assumption
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`in either of its petitions. Not all heat treatments will necessarily result in a shank
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`having the claimed permanent deformation. In fact, Petitioner admitted in its first
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`petition that the primary reference upon which it relied—Kuhn—describes a heat
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`treatment process performed at a temperature falling within all of the patent
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`claims—510 °C—that did not cause the nickel titanium instrument to lose its
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`superelasticity. Ex. 2023, 32 (“The 510 °C treatment did not produce a
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`transformation temperature above 37 °C, nor did the resulting instrument show
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`significant permanent deformation.”). Kuhn thereby demonstrates that not all heat
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`treatments in the claimed ranges will necessarily produce a permanently
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`deformable shank. This distinction highlights the purpose of the permanent
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`deformation limitations in the patent claims. The patent claims do not encompass a
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`heat treatment process that does not transform the superelastic nickel titanium
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`shank into a shank that then exhibits greater than 10 degrees permanent
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`deformation after testing in the ISO Standard 3630-1 bend test.
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