`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`EDGE ENDO, LLC,
`Petitioner
`
`v.
`
`MICHAEL SCIANAMBLO,
`Patent Owner
`____________________
`
`Case No. IPR2018-01320
`U.S. Patent No. 8,882,504
`____________________
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`Submitted Electronically via the PTAB E2E System
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`
`
`Page
`
`EXHIBIT LIST .......................................................................................................... v
`
`I.
`
`MANDATORY NOTICES (37 C.F.R. §42.8) ................................................ 1
`
`A.
`
`Real Party in Interest (37 C.F.R. §42.8(b)(1)) ...................................... 1
`
`B.
`
`C.
`
`Related Matters (37 C.F.R. §42.8(b)(2)) ............................................... 1
`
`Lead and Back-Up Counsel (37 C.F.R. §42.8(b)(3)) and Service
`Information (37 C.F.R. §42.8(b)(4)) ..................................................... 2
`
`II.
`
`PAYMENT OF FEES (37 C.F.R. §42.103) .................................................... 2
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW (37 C.F.R.
`§42.104) ........................................................................................................... 3
`
`A. Grounds for Standing (37 C.F.R. §42.104(a)) ...................................... 3
`
`B.
`
`Identification of Challenge (37 C.F.R. §42.104(b)(1)-(2)) and
`Relief Requested (37 C.F.R. §42.22(a)(1)) ........................................... 3
`
`IV. BACKGROUND AND SUMMARY OF THE '504 PATENT ...................... 5
`
`A. Overview of the '504 Patent .................................................................. 5
`
`B.
`
`Prosecution History of the '504 Patent .................................................. 6
`
`V.
`
`LEVEL OF ORDINARY SKILL IN THE ART ........................................... 11
`
`VI. CLAIM CONSTRUCTION (37 C.F.R. §42.104(b)(3)) ................................ 12
`
`A.
`
`"swagger"/"swaggers" ......................................................................... 12
`
`B.
`
`"polygonal shape" ................................................................................ 13
`
`VII. DETAILED EXPLANATION OF UNPATENTABILITY
`GROUNDS .................................................................................................... 14
`
`A. Overview of the Prior Art .................................................................... 14
`
`1. McSpadden ................................................................................ 14
`
`i
`
`

`

`
`
`2.
`
`3.
`
`4.
`
`Rouiller ...................................................................................... 15
`
`Badoz......................................................................................... 17
`
`Garman ...................................................................................... 18
`
`B.
`
`Ground 1: Claims 1-4, 7-9, and 14 are Anticipated by
`McSpadden .......................................................................................... 19
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Independent claim 1 .................................................................. 19
`
`Dependent claims 2 and 3 ......................................................... 31
`
`Dependent claim 4 .................................................................... 31
`
`Dependent claim 7 .................................................................... 32
`
`Dependent claims 8 and 9 ......................................................... 33
`
`Dependent claim 14 .................................................................. 34
`
`C.
`
`Ground 2: Dependent Claims 6, 10, and 11 are Obvious Over
`McSpadden in View of Garman .......................................................... 34
`
`D. Ground 3: Claims 1, 4, 7-9, and 14 are Anticipated By Rouiller;
`Ground 4: Claims 1, 4, 7-9, and 14 are Obvious Over Rouiller ......... 37
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Independent claim 1 .................................................................. 37
`
`Dependent claim 4 .................................................................... 44
`
`Dependent claim 7 .................................................................... 44
`
`Dependent claims 8 and 9 ......................................................... 45
`
`Dependent claim 14 .................................................................. 46
`
`E.
`
`Ground 5: Dependent Claims 2, 3, 6, 10, and 11 are Obvious
`Over Rouiller in View of Garman ....................................................... 46
`
`1.
`
`2.
`
`Dependent claims 2 and 3 ......................................................... 46
`
`Dependent claims 6, 10, and 11 ................................................ 47
`
`F.
`
`Ground 6: Claims 1, 4, 7-9, and 14 are Obvious Over Badoz ............ 48
`
`ii
`
`

`

`
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Independent claim 1 .................................................................. 49
`
`Dependent claim 4 .................................................................... 54
`
`Dependent claim 7 .................................................................... 54
`
`Dependent claims 8 and 9 ......................................................... 55
`
`Dependent claim 14 .................................................................. 56
`
`G. Ground 7: Dependent Claims 2, 3, 6, 10, and 11 are Obvious
`Over Badoz in View of Garman .......................................................... 56
`
`1.
`
`2.
`
`Dependent claims 2 and 3 ......................................................... 57
`
`Dependent claims 6, 10, and 11 ................................................ 58
`
`H. No Secondary Considerations of Non-obviousness ............................ 59
`
`VIII. CONCLUSION .............................................................................................. 59
`
`
`
`
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
`
`
` Page(s)
`
`
`
`Cases
`
`Acclarent, Inc. v. Ford Albritton, IV,
`Case IPR2017-00498, slip op. (PTAB July 10, 2017)........................................ 11
`
`Alcon Research, Ltd. v. Apotex Inc.,
`687 F.3d 1362 (Fed. Cir. 2012) ...................................................................passim
`
`Amneal Pharms., LLC v. Supernus Pharms., Inc.,
`IPR2013-00368, slip op. (PTAB Dec. 17, 2013)................................................ 59
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) ........................................................................................ 12
`
`Edwards Lifesciences Corp. v. Boston Scientific Scimed Inc.,
`Case IPR2017-01295, slip op. (PTAB Oct. 25, 2017) ....................................... 11
`
`Google Inc. v. Blackberry Ltd.,
`Case IPR2017-00914, slip op. (PTAB Sept. 11, 2017) ...................................... 11
`
`King Pharms. v. Eon Labs.,
`616 F.3d 1267 (Fed. Cir. 2010) ...................................................................passim
`
`Limelight Networks, Inc. v. Akamai Techs., Inc.,
`Case IPR2016-01711, slip op. (PTAB Mar. 6, 2017)......................................... 11
`
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) ...................................................................passim
`
`
`
`Statutes
`
`35 U.S.C. §102 ....................................................................................................... 3, 4
`
`35 U.S.C. §103 ........................................................................................................... 3
`
`35 U.S.C. §325 ......................................................................................................... 11
`
`iv
`
`

`

`
`
`EXHIBIT LIST
`
`Description
`U.S. Patent No. 8,882,504 to Scianamblo
`File History of U.S. Patent No. 8,882,504
`Declaration of Gary Garman
`U.S. Patent Application No. 2004/0023186 to McSpadden
`U.S. Patent No. 6,299,445 to Garman
`WO 02/065938 to Rouiller et al. – Original French
`English Translation of WO 02/065938 to Rouiller et al. and
`Certification of Jacqueline Yorke
`WO 01/19279 to Badoz – Original French
`English Translation of WO 01/19279 to Badoz and
`Certification of Aurora Landman
`Walia, H., et al., An Initial Investigation of the Bending and
`Torsional Properties of Nitinol Root Canal Files, 14 J.
`Endodontics 346 (1988)
`U.S. Patent No. 5,882,198 to Taylor et al.
`U.S. Patent No. 4,299,571 to McSpadden
`Aliuddin, SK, et al., Historical Milestones in Endodontics: Review
`of Literature, Int. J. Prev. Clin. Dent. Res. 2017;4(1):56-58
`U.S. Patent Application No. 2004/0043357 to Garman
`U.S. Patent No. 5,873,719 to Calas et al.
`U.S. Patent No. 5,975,899 to Badoz et al.
`U.S. Patent Application No. 2006/0228668 to McSpadden
`U.S. Patent Application No. 2004/0131993 to Rouiller et al.
`
`Exhibit No.
`1001
`1002
`1003
`1004
`1005
`1006
`1007
`
`1008
`1009
`
`1010
`
`1011
`1012
`1013
`
`1014
`1015
`1016
`1017
`1018
`
`v
`
`

`

`Edge Endo, LLC ("Edge Endo" or "Petitioner") respectfully requests inter
`
`partes review ("IPR") under 35 U.S.C. §§311-319 and 37 C.F.R., Part 42 of claims
`
`1-4, 6-11, and 14 ("the challenged claims") of U.S. Patent No. 8,882,504 (Ex.
`
`1001, "the '504 patent"). There is a reasonable likelihood that Petitioner will
`
`prevail with respect to at least one challenged claim.
`
`I.
`
`MANDATORY NOTICES (37 C.F.R. §42.8)
`
`A.
`
`Real Party in Interest (37 C.F.R. §42.8(b)(1))
`
`Petitioner Edge Endo, LLC, as well as US Endodontics, LLC, Charles
`
`Goodis, Bobby Bennett, Edge Holdings, LLC and Guidance Endodontics, LLC are
`
`real parties-in-interest. Petitioner does not believe that any other entity is a real
`
`party-in-interest, but nonetheless identifies that Edge Endo and US Endodontics,
`
`LLC are owned by Edge Holdings, LLC, which is majority owned by Peter
`
`Brasseler Holdings, LLC, which is majority owned by SG Healthcare Corp., which
`
`is owned by Henry Schein, Inc.
`
`Related Matters (37 C.F.R. §42.8(b)(2))
`B.
`The '504 patent is asserted in Dentsply Sirona Inc., et al. v. Edge Endo, LLC,
`
`et al., No. 1:17-CV-01041 (D.N.M.). Petitioner has also filed petitions for IPR of
`
`related U.S. Patent Nos. 8,932,056 (Case No. IPR2018-01321) and 9,351,803
`
`(Case No. IPR2018-01322), which are asserted in the district court litigation.
`
`Patent Owner, Michael Scianamblo, has a related pending patent application that
`
`might be affected by this proceeding: U.S. Pat. Appl. Ser. No. 15/607,066.
`
`1
`
`

`

`Petitioner is not aware of any other pending administrative matter or litigation that
`
`would affect, or be affected by, a decision in this proceeding.
`
`C.
`
`Lead and Back-Up Counsel (37 C.F.R. §42.8(b)(3)) and Service
`Information (37 C.F.R. §42.8(b)(4))
`
`Lead Counsel:
`
`Jeffrey S. Ginsberg
`(Reg. No. 36,148)
`Patterson Belknap Webb & Tyler LLP
`1133 Avenue of the Americas
`New York, NY 10036
`jginsberg@pbwt.com
`(212) 336-2630
`
`Back-Up Counsel: Abhishek Bapna
`(Reg. No. 64,049)
`Patterson Belknap Webb & Tyler LLP
`1133 Avenue of the Americas
`New York, NY 10036
`abapna@pbwt.com
`(212) 336-2617
`
`Pursuant to 37 C.F.R. §42.8(b)(4), counsel agrees to service by mail, and to
`
`electronic service by e-mail. Pursuant to 37 C.F.R. §42.10(b), a Power of Attorney
`
`accompanies this Petition.
`
`II.
`
`PAYMENT OF FEES (37 C.F.R. §42.103)
`
`In accordance with 37 C.F.R. §§42.15(a) and 42.103, Petitioner authorizes
`
`the Commissioner to charge all fees due to Attorney Deposit Account No. 506642.
`
`2
`
`

`

`
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW (37 C.F.R. §42.104)
`
`A. Grounds for Standing (37 C.F.R. §42.104(a))
`
`Petitioner certifies that the '504 patent is available for IPR. This Petition has
`
`been filed less than one year after the date on which Petitioner was served with a
`
`complaint alleging infringement of the '504 patent. Petitioner is not barred or
`
`estopped from requesting IPR on the grounds identified herein.
`
`B.
`
`Identification of Challenge (37 C.F.R. §42.104(b)(1)-(2)) and
`Relief Requested (37 C.F.R. §42.22(a)(1))
`
`Petitioner requests that claims 1-4, 6-11, and 14 of the '504 patent (Ex. 1001)
`
`be cancelled as unpatentable because they are anticipated under 35 U.S.C. §102
`
`and/or obvious under 35 U.S.C. §103 in view of prior art on the following grounds:
`
`Ground 1
`Anticipation by U.S. Pat. Appl. Pub. No. 2004/0023186
`("McSpadden," Ex. 1004)
`Ground 2
`Obviousness over McSpadden in view of U.S. Pat. No.
`6,299,445 ("Garman," Ex. 1005)
`Ground 3
`Anticipation by WO 02/065938 ("Rouiller," Exs. 1006,
`1007)1
`
`Ground 4
`Obviousness over Rouiller
`
`Challenged Claims
`
`1-4, 7-9, 14
`
`Challenged Claims
`
`6, 10-11
`
`Challenged Claims
`
`1, 4, 7-9, 14
`
`Challenged Claims
`1, 4, 7-9, 14
`
`
`
`1 Exhibits 1006 and 1008 are the original references in the French language.
`
`Exhibit 1007 and 1009 are the respective certified translations. Citations herein are
`
`to the latter.
`
`3
`
`

`

`
`
`Ground 5
`Obviousness over Rouiller in view of Garman
`Ground 6
`Obviousness over WO 01/19279 ("Badoz," Exs. 1008,
`1009)1
`
`Ground 7
`Obviousness over Badoz in view of Garman
`
`
`Challenged Claims
`2-3, 6, 10-11
`Challenged Claims
`1, 4, 7-9, 14
`
`Challenged Claims
`2-3, 6, 10-11
`
`For purposes of this proceeding only, Petitioner assumes that the earliest
`
`effective filing date of the '504 patent is April 8, 2005, which is the filing date for
`
`U.S. Provisional Application No. 60/669,409, to which the '504 patent claims
`
`priority.2 Ex. 1001, p. 1.
`
`McSpadden published on February 5, 2004, and thus qualifies as prior art
`
`under pre-AIA 35 U.S.C. §102(b).
`
`Rouiller published on August 29, 2002, and thus qualifies as prior art under
`
`pre-AIA 35 U.S.C. §102(b).
`
`Garman issued on October 9, 2001, and thus qualifies as prior art under pre-
`
`AIA 35 U.S.C. §102(b).
`
`Badoz published on March 22, 2001, and thus qualifies as prior art under
`
`pre-AIA 35 U.S.C. §102(b).
`
`
`2 The detail on the face of the '504 patent providing that U.S. Provisional
`
`Application No. 60/669,409 was filed on April 8, 2004 is a typographical error. Ex.
`
`1001, p. 56 (Certificate of Correction).
`
`4
`
`

`

`
`
`IV. BACKGROUND AND SUMMARY OF THE '504 PATENT
`
`A. Overview of the '504 Patent
`
`The '504 patent relates to endodontic instruments, and specifically, "methods
`
`and apparatus for providing swaggering endodontic instruments for preparing an
`
`endodontic cavity space." Ex. 1001, 1:16, 3:52-54; Ex. 1003, ¶¶30-35.3 "Swagger"
`
`is not a conventional term in the relevant art. See infra Section VI.A.; Ex. 1003,
`
`¶48. Rather, it appears to be a term provided by the applicant, which, "[a]s applied
`
`to an endodontic file or reamer," "is viewed as a transverse mechanical wave,
`
`which can be modified." Ex. 1001, 18:46-48; Ex. 1003, ¶35. The '504 patent
`
`describes this wave as comparable to a transverse wave that can be generated by
`
`tying the loose end of a long rope to a fixed point, stretching the rope horizontally,
`
`and then giving the end being held a back-and-forth transverse motion. Ex. 1001,
`
`18:48-52; Ex. 1003, ¶¶35-36. A wave pulse would travel along the length of the
`
`rope, and the amplitude of the wave would vary sinusoidally. Ex. 1001, 18:53-67;
`
`Ex. 1003, ¶¶35-36.
`
`The '504 patent further explains that "when the center of mass of the system
`
`corresponds to the axis [of] rotation, the system is in equilibrium and the
`
`instrument turns evenly around the axis." Ex. 1001, 20:32-34; Ex. 1003, ¶36. On
`
`
`3 Citations are to the column and line number for patents, and either paragraph
`
`number or page and line numbers for other patent publications.
`
`5
`
`

`

`
`
`the other hand, "when the center of mass or the centroid [of] the system is at a
`
`distance from the center of rotation, similar to an endodontic instrument of singly
`
`symmetric cross section, the system is out of equilibrium and will tend to
`
`swagger." Ex. 1001, 20:34-38; Ex. 1003, ¶36; see also Ex. 1003, ¶¶37-43.
`
`Instruments designed to swagger undulate within the endodontic cavity
`
`space ("ECS") to cut away material. Ex. 1001, 37:55-57; Ex. 1003, ¶43. As a result
`
`of this undulation, fewer cutting edges are in contact with the endodontic cavity
`
`wall at any given time. Ex. 1001, 29:64-66; Ex. 1003, ¶43. And, according to the
`
`'504 patent, endodontic instruments having fewer cutting edges in contact with the
`
`cavity wall are less susceptible to certain problems, such as binding with the
`
`endodontic cavity wall and breakage caused by heavy torque loading, and can
`
`more uniformly clean the ECS. See, e.g., Ex. 1001, 5:66-6:11, 7:19-24, 9:3-7, 9:53-
`
`58; Ex. 1003, ¶¶25, 27, 33.
`
`B.
`
`Prosecution History of the '504 Patent
`
`Though neither McSpadden nor Rouiller was discussed during prosecution
`
`of the application that resulted in the issuance of the '504 patent, U.S. Pat. Appl.
`
`Ser. No. 13/804,084 ("the '084 application"), references related to McSpadden and
`
`Rouiller were discussed. But key disclosures in these references appear to have
`
`been overlooked. And, while Garman and a reference related to Badoz were
`
`6
`
`

`

`
`
`identified, they were not discussed during prosecution.4 As set forth below, this
`
`Petition is based on critical disclosures in these references, and presents arguments
`
`and supporting expert testimony not previously considered by the United States
`
`Patent and Trademark Office ("PTO").
`
`In a non-final office action, dated November 4, 2013, then-pending claims 1-
`
`3, 23-25, and 27-28 were rejected under, among other grounds, 35 U.S.C. §102(e)
`
`as anticipated by U.S. Pat. Appl. Pub. No. 2006/0228668 ("the related McSpadden
`
`reference," Ex. 1017),5 and then-pending claim 26 was rejected under 35 U.S.C.
`
`§103(a) as rendered obvious by the related McSpadden reference. Ex. 1002, pp.
`
`144-146, 149. These initially-rejected claims each incorporated the limitation:
`
`"centers of mass of transverse cross sections of the body [of the endodontic
`
`instrument] defining a mass path, wherein at least a portion of the mass path is off
`
`the axis of rotation." Ex. 1002, p. 59. Against this limitation, the examiner
`
`referenced Figures 3A and 3C and paragraphs 46-49 of the related McSpadden
`
`
`4 Garman and the related Badoz reference were identified in a March 3, 2014
`
`Information Disclosure Statement along with 52 other references. Ex. 1002, pp.
`
`176-179.
`
`5 The related McSpadden reference is a continuation-in-part of, and in substantial
`
`part includes the disclosures of, McSpadden. Compare Ex. 1017 with Ex. 1004.
`
`7
`
`

`

`
`
`reference.6 Ex. 1002, pp. 144-45.
`
`In a March 3, 2014 response, Patent Owner argued that the endodontic
`
`instrument described in the related McSpadden reference "has a segment of its
`
`working portion offset from the axis of rotation while the majority of its working
`
`portion is centered with the axis of rotation." Ex. 1002, p. 171. In so doing, Patent
`
`Owner ignored the clear teachings of this reference, including Figures 3A and C
`
`(reproduced below with annotations in red), showing a wave-like offset from the
`
`axis of rotation along the entire length of working portion.
`
`
`6 The cited figures and paragraphs correspond to Figures 3A and 3C and
`
`
`
`paragraphs 49-52, respectively, of McSpadden.
`
`8
`
`

`

`
`
`Ex. 1004, Figs. 3A and 3C; see also Ex. 1003, ¶83.
`
`The only other instance during prosecution in which the related McSpadden
`
`reference was discussed was in connection with a final office action dated June 12,
`
`2014. Ex. 1002, pp. 204, 215-16. In that office action, the related McSpadden
`
`reference was relied on only in connection with an obviousness rejection of then-
`
`pending dependent claim 32, which included the limitation "wherein the body has
`
`at least three regions of different rates of diametrical taper." Id. at 189, 194. Claim
`
`32 was later cancelled, id. at 285, 289, and the cancelled limitation does not appear
`
`in the issued claims of the '504 patent.
`
`After further amendment, claim 1 was allowed. Ex. 1002, pp. 249, 266.
`
`Patent Owner's cumulative amendments, however, do not distinguish claim 1 of the
`
`'504 patent over the related McSpadden reference. Notably, in addition to not
`
`appreciating the relevance of Figures 3A and 3C, the examiner did not cite or refer
`
`to key disclosures from the related McSpadden reference that correspond to those
`
`of McSpadden upon which Petitioner relies in this Petition, e.g., Ex. 1004, ¶¶53,
`
`58-63, which are discussed in detail below. See infra Section VII.B. (Ground 1).
`
`A key disclosure in Rouiller was also overlooked during prosecution. The
`
`November 4, 2013 office action discussed above also included a rejection of then-
`
`pending claims 1, 4-6, and 8 under 35 U.S.C. §102(b) as anticipated by U.S. Pat.
`
`Appl. Pub. No. 2004/0131993 to Rouiller ("the related Rouiller reference," Ex.
`
`9
`
`

`

`
`
`1018),7 Ex. 1002, pp. 143-44, and a rejection of then-pending claim 13 under 35
`
`U.S.C. §103(a) as rendered obvious by the related Rouiller reference in
`
`combination with two other references not at issue in this proceeding, id. at 148-
`
`49. However, the examiner did not cite or refer to a key passage in the related
`
`Rouiller reference (paragraph 30), which also appears in Rouiller (Ex. 1007, 7:11-
`
`17) and upon which Petitioner relies herein. See infra Section VII.D. (Ground 3).
`
`Further, at the time of the rejection over the related Rouiller reference, the then-
`
`pending claims did not include the following limitation that was later added in
`
`response to the examiner's rejections over the prior art: "[wherein the swagger
`
`results in], along an entire length of the working surface, one or more edges of the
`
`multiple cutting edges being out of [contact with] a wall of [the endodontic cavity
`
`space]." Compare Ex. 1002, pp. 59-62 with id. at 189-90.
`
`Additionally, in this Petition, for certain dependent claims, Petitioner relies
`
`on McSpadden, Rouiller, and Badoz as obviousness references in combination
`
`with Garman—combinations not identified during the prosecution of the '084
`
`application.
`
`For the foregoing reasons, none of the grounds in this Petition raises
`
`"substantially the same" arguments previously considered by the PTO. The
`
`
`7 The related Rouiller reference is the U.S. counterpart of, and has disclosures in
`
`common with, Rouiller. Compare Ex. 1018 with Ex. 1007.
`
`10
`
`

`

`
`
`unpatentability arguments presented in this Petition are based on disclosures in the
`
`identified references and/or combinations that have never been addressed by the
`
`PTO and are accompanied by new evidence, including the declaration of Gary
`
`Garman, which confirm the unpatentability of the challenged claims. Accordingly,
`
`the Board should decline to exercise its discretion under 35 U.S.C. §325(d), and
`
`should institute review on all grounds presented. See, e.g., Limelight Networks, Inc.
`
`v. Akamai Techs., Inc., Case IPR2016-01711, slip op. at 21-22 (PTAB Mar. 6,
`
`2017) (Paper 10); Acclarent, Inc. v. Ford Albritton, IV, Case IPR2017-00498, slip
`
`op. at 5-6 (PTAB July 10, 2017) (Paper 12); Google Inc. v. Blackberry Ltd., Case
`
`IPR2017-00914, slip op. at 21(PTAB Sept. 11, 2017) (Paper 7); Edwards
`
`Lifesciences Corp. v. Boston Scientific Scimed Inc., Case IPR2017-01295, slip op.
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`at 27 (PTAB Oct. 25, 2017) (Paper 9).
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`V. LEVEL OF ORDINARY SKILL IN THE ART
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`The art to which the '504 patent relates is the field of endodontic
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`instruments. Ex. 1001, 1:16. A person of ordinary skill in the art as of April 2005
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`(a "POSITA") would have had at least a Bachelor's degree in mechanical
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`engineering or a related field, and at least two years of work experience in the
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`design and/or operation of endodontic instruments. Ex. 1003, ¶¶54-55.
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`VI. CLAIM CONSTRUCTION (37 C.F.R. §42.104(b)(3))
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`A claim subject to IPR is to be given its broadest reasonable construction in
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`light of the specification. 37 C.F.R. §42.100(b); Cuozzo Speed Techs., LLC v. Lee,
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`136 S. Ct. 2131 (2016). Petitioner provides below, for the purposes of this
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`proceeding only, the construction of several terms applying this standard.8
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`A.
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`"swagger"/"swaggers"
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`Claim 1 recites that "the working surface of the body swaggers when the
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`instrument is rotated about the axis of rotation at a speed appropriate for preparing
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`the endodontic cavity space, wherein the swagger results in, along an entire length
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`of the working surface, one or more cutting edges of the multiple cutting edges
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`being out of contact with a wall of the endodontic cavity space" (emphasis added).
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`Claims 15 and 18, which are not at issue in this IPR, also recite "swagger."
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`Relatedly, challenged claims 8 and 9 together require that when the instrument of
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`claim 1 is rotated, the body forms one or more half-waves of a sinusoid.
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`The term "swagger" does not have an ordinary and customary meaning such
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`that a POSITA would necessarily know what it means without referring to the '504
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`8 Petitioner may seek additional and/or alternate claim constructions in district
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`court. Further, Petitioner does not concede that the challenged claims are definite,
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`but only that the scope of the claims, as asserted by Patent Owner, extends at least
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`to the prior art as described herein.
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`patent for context. Ex. 1003, ¶48. As mentioned above, "swagger" is a term
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`provided by the listed inventor to describe the phenomenon, with respect to an
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`endodontic instrument, of "a transverse mechanical wave." See supra Section
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`IV.A.; Ex. 1001, 18:46-67; Ex. 1003, ¶¶48-49. Accordingly, "swagger" should be
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`construed as "wave-like movement," and "swaggers" should be construed as
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`"moves in a wave-like manner." Ex. 1003, ¶¶48-49.9
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`B.
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`"polygonal shape"
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`Claim 1 recites that "the plurality of transverse cross-sections are defined by
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`a polygonal shape that rotates about the axis of rotation from the shank end to the
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`tip end." Challenged claims 4 and 6, as well as claim 5, which is not at issue in this
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`proceeding, also recite "polygonal shape." The specification describes cross-
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`sections of an endodontic instrument having one of various multi-sided shapes,
`
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`9 In the related district court action, Patent Owner's licensees advanced the
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`following claim construction for the term swagger: "deflection which occurs
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`during use of the instrument when it is rotated at a speed appropriate for preparing
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`an endodontic cavity space." While Petitioner disputes that this is the proper
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`interpretation for "swagger" under the broadest reasonable standard or otherwise, if
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`adopted, the primary prior art references in each of the asserted grounds of
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`unpatentability would still disclose the "swagger" limitations. See, e.g., Ex. 1003,
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`¶88, n.4, ¶127, n.5 and ¶159, n.6.
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`including, among others, triangular and rectangular. Ex. 1001, 31:35-52, 32:9-11,
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`33:32-34, 34:55-57, 36:31-39, 36:62-37:4. Numerous figures included in the '504
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`patent depict a cross-sectional shape without straight sides. Ex. 1001, Fig. 7D, 8B,
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`9H, 21D, 21E, 22A-22D, 23D, 24D, 24E, 25D, 25E, 27A-27C, 28A, 28B, 29A,
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`29B. Further, the specification states: "The term polygon approximates the shape
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`and is not meant to indicate that the sides necessarily are linear." Ex. 1001, 37:4-6.
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`Accordingly, "polygonal shape" should be construed as "a shape approximating a
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`polygon with sides that are not necessarily linear." Ex. 1003, ¶50.
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`VII. DETAILED EXPLANATION OF UNPATENTABILITY GROUNDS
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`The challenged claims are unpatentable in view of the prior art for the
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`reasons discussed below.
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`A. Overview of the Prior Art
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`1. McSpadden
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`McSpadden discloses that a problematic aspect of conventional endodontic
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`files having twisting or helically spiraling cutting edges is that they often bind
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`with, or burrow into, the root canal, potentially causing the file to inadvertently
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`drive deep into the root canal, to puncture the apical seal of the canal, and to
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`otherwise transport through the canal wall. Ex. 1004, ¶¶8, 33; Ex. 1003, ¶58.
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`Another prevalent problem described in McSpadden is heavy torque loading
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`caused by inefficient cutting or high surface area engagement of the file with the
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`inner canal wall, leading to "catastrophic failure." Id. McSpadden discloses an
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`endodontic file designed to alleviate the problems associated with conventional
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`endodontic files. Ex. 1004, ¶¶60, 61; Ex. 1003, ¶58. These are the same problems
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`that are stated to be solved by the alleged invention described in the '504 patent.
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`See supra Section IV.A.; Ex. 1003, ¶¶25, 58.
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`McSpadden discloses an endodontic instrument formed from a shaft having
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`a generally twisted or fluted prismatic shape defined by three or more side surfaces
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`and three or more interposed corners. Ex. 1004, ¶11; Ex. 1003, ¶59. The shaft
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`includes a working portion having one or more helical cutting edges, the working
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`portion tapered along its length in accordance with a first predetermined taper
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`function and further tapered in accordance with a second taper function. Ex. 1004,
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`¶11; Ex. 1003, ¶60. In one embodiment, the corners of the shaft assume a helical or
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`spiraling shape. Ex. 1004, ¶13; Ex. 1003, ¶60. McSpadden teaches that, in this
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`embodiment, the second taper function modulates the center axis of the polygonal
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`(e.g., triangular or square) cross-section relative to the central axis of the
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`instrument such that the cross-section of the instrument winds "cork-screw-like"
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`from the proximal end to the distal end within an envelope defined by the first and
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`second taper functions. Ex. 1004, ¶¶52, 59, 61, 63; Ex. 1003, ¶60.
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`2.
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`Rouiller
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`Rouiller identifies, and sets out to solve, the same problems encountered
`
`with then-existing endodontic files as those discussed above that are described in
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`
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`McSpadden and the '504 patent. See supra Sections IV.A. and VII.A.1; Ex. 1003,
`
`¶61. Specifically, Rouiller explains that with conventional endodontic files, the
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`friction between the cutting edges and the walls of the canal causes significant
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`torque applied on the file, which may cause it to break, and that conventional files
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`are more likely to bind with the endodontic cavity wall. Ex. 1007, 1:25-26, 2:6-8,
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`3:6-8, 3:12-15, 8:5-14; Ex. 1003, ¶61.
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`Rouiller discloses an endodontic instrument having a base (i.e., a shank), a
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`cutting section (i.e., a working portion), and a guiding section (i.e., a tip). Ex.
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`1007, 5:22-23; Ex. 1003, ¶¶62-63. The instrument is either cylindrical or tapered
`
`and has a circular or polygonal (e.g., triangular or square) cross-section. Ex. 1007,
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`5:23-30; Ex. 1003, ¶¶62-63. Rouiller teaches that a triangular cross-section has
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`sharp edges that define three flutes helicoidal in shape and placed within an
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`envelope. Ex. 1007, 6:4-8; Ex. 1003, ¶64. Rouiller also teaches that the axis of the
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`envelope is moved a distance from the axis of the cutting section, such that one or
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`more edges are set back within the envelope, and that the axis of the cutting section
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`is helicoidal and is wound up into a helix around the axis of the envelope. Ex.
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`1007, 7:11-17; Ex. 1003, ¶65. Rouiller further explains that this design makes it
`
`possible to deepen the clearance zones and to make them more effective for
`
`carrying material during treatment. Ex. 1007, 7:15-17; Ex. 1003, ¶65.
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`3.
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`Badoz
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`Badoz attempts to solve the same problems as the '504 patent, McSpadden,
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`and Rouiller, where "the forces applied during the preparation of the canal are no
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`longer balanced and the trajectory of the instrument may deviate with respect to the
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`axis of the root canal," which can have "very serious consequences, since it can
`
`lead to the creation of a directional mishap or even a perforation of the canal." Ex.
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`1009, 1:15-19; Ex. 1003, ¶66. Badoz describes an endodontic instrument that
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`alleviates these concerns by "intentionally breaking the circular symmetry of the
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`instrument, so that the tip of the instrument is able to search for the root canal and
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`penetrate it naturally, since the bending resistance of the blade is no longer the
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`same in all directions." Ex. 1009, 1:21-24; Ex. 1003, ¶66.
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`The endodontic instrument disclosed in Badoz is "of the root-canal reamer
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`type, comprising a working section (10) including three flutes (20, 21, 22) forming
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`three cutting lips (30, 31, 32). It is characterize