`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`EDGE ENDO, LLC,
`Petitioner
`
`v.
`
`MAILLEFER INSTRUMENTS HOLDING S.A.R.L.
`Patent Owner
`____________________
`
`Case No. IPR2018-01349
`U.S. Patent No. 9,801,696
`____________________
`
`
`
`
`
`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
`
`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. §42.83(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 '696 PATENT ...................... 5
`
`A. Overview of the '696 Patent .................................................................. 5
`
`B.
`
`Prosecution History of the '696 Patent .................................................. 7
`
`V.
`
`LEVEL OF ORDINARY SKILL IN THE ART ........................................... 10
`
`VI. CLAIM CONSTRUCTION (37 C.F.R. §42.104(B)(3)) ............................... 10
`
`A.
`
`"a tapered rod defined by a single continuous taper function" ........... 11
`
`B.
`
`"a polygonal cross-section" ................................................................. 15
`
`VII. DETAILED EXPLANATION OF UNPATENTABILITY GROUNDS ..... 16
`
`A. Overview of the Prior Art .................................................................... 16
`
`1. McSpadden .................................................................................. 16
`
`2. Scianamblo .................................................................................. 19
`
`3. Badoz ........................................................................................... 21
`
`i
`
`

`

`
`
`4. Taylor .......................................................................................... 23
`
`5. Garman ........................................................................................ 24
`
`B.
`
`Ground 1: Claims 1, 2, 5, and 8 are Anticipated by McSpadden;
`Ground 2: Claims 1, 2, 5, 8, and 10 are Obvious Over McSpadden... 28
`
`1.
`
`Independent claim 1 .................................................................... 28
`
`2. Dependent claim 2 ....................................................................... 37
`
`3. Dependent claim 5 ....................................................................... 37
`
`4. Dependent claim 8 ....................................................................... 38
`
`5. Dependent claim 10 ..................................................................... 39
`
`C.
`
`Ground 3: Claim 9 is Obvious Over McSpadden in View of
`Garman ................................................................................................ 40
`
`D. Ground 4: Claims 1, 2, 5, 8, and 10 are Obvious Over Scianamblo ... 43
`
`1.
`
`Independent claim 1 .................................................................... 43
`
`2. Dependent claim 2 ....................................................................... 51
`
`3. Dependent claim 5 ....................................................................... 52
`
`4. Dependent claim 8 ....................................................................... 52
`
`5. Dependent claim 10 ..................................................................... 54
`
`E.
`
`F.
`
`Ground 5: Claim 9 is Obvious Over Scianamblo in View of
`Garman ................................................................................................ 54
`
`Ground 6: Claims 1, 2, 5, and 10 are Obvious Over Badoz in
`View of Taylor .................................................................................... 56
`
`1.
`
`Independent claim 1 .................................................................... 56
`
`2. Dependent claim 2 ....................................................................... 62
`
`3. Dependent claim 5 ....................................................................... 62
`
`4. Dependent claim 10 ..................................................................... 63
`
`ii
`
`

`

`
`
`G. Ground 7: Claims 8 and 9 are Obvious Over Badoz in View
`of Taylor and in Further View of Garman .......................................... 64
`
`1. Dependent claim 8 ....................................................................... 64
`
`2. Dependent claim 9 ....................................................................... 65
`
`H. No Secondary Considerations of Non-obviousness ............................ 67
`
`VIII. CONCLUSION .............................................................................................. 68
`
`
`
`
`
`
`
`
`
`
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
`
`
` Page(s)
`
`Cases
`
`Acclarent, Inc. v. Ford Albritton, IV,
`Case IPR2017-00498, slip op. (PTAB July 10, 2017)........................................ 10
`
`Amneal Pharms., LLC v. Supernus Pharms., Inc.,
`IPR2013-00368, slip op. (PTAB Dec. 17, 2013)................................................ 68
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) ........................................................................................ 10
`
`Edwards Lifesciences Corp. v. Boston Scientific Scimed, Inc.,
`Case IPR2017-01295, slip op. (PTAB Oct. 25, 2017) ....................................... 10
`
`Google, Inc. v. Blackberry Ltd.,
`Case IPR2017-00914, slip op. (PTAB Sept. 11, 2017) ...................................... 10
`
`Limelight Networks, Inc. v. Akamai Techs., Inc.,
`Case IPR2016-01711, slip op. (PTAB Mar. 6, 2017)......................................... 10
`
`Statutes
`
`35 U.S.C. §102 ....................................................................................................... 3, 4
`
`35 U.S.C. §103 ........................................................................................................... 3
`
`35 U.S.C. §325 ........................................................................................................... 9
`
`iv
`
`

`

`
`
`Exhibit No.
`1001
`1002
`1003
`1004
`1005
`1006
`1007
`1008
`
`1009
`1010
`1011
`1012
`1013
`
`1014
`1015
`1016
`
`EXHIBIT LIST
`
`Description
`U.S. Pat. No. 9,801,696 to Rota et al.
`File History of U.S. Patent No. 9,801,696
`Declaration of Gary Garman
`U.S. Pat. Appl. No. 2004/0023186 to McSpadden
`U.S. Pat. No. 6,299,445 to Garman
`U.S. Pat. Appl. No. 2006/0228669 to Scianamblo
`WO 01/19279 to Badoz – Original French
`English Translation of WO 01/19279 to Badoz and
`Certification of Aurora Landman
`U.S. Pat. No. 5,882,198 to Taylor et al.
`U.S. Pat. Appl. No. 2006/0228668 to McSpadden
`U.S. Pat. No. 4,299,571 to McSpadden
`U.S. Pat. No. 4,850,867 to Senia et al.
`Aliuddin, SK, et al., Historical Milestones in Endodontics: Review
`of Literature, Int. J. Prev. Clin. Dent. Res. 2017; 4(1):56-58
`McSpadden, J.T., Mastering Endodontic Instrumentation (2007)
`WO 02/065938 to Rouiller et al. – Original French
`English Translation of WO 02/065938 to Rouiller et al. and
`Certification of Jacqueline Yorke
`
`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, 2, 5, and 8-10 ("the challenged claims") of U.S. Patent No. 9,801,696 (Ex. 1001,
`
`"the '696 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, LLC 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.
`
`B. Related Matters (37 C.F.R. §42.8(b)(2))
`
`The '696 patent is asserted in Dentsply Sirona, Inc., et al. v. Edge Endo,
`
`LLC, et al., No. 1:17-CV-01041 (D.N.M.). Patent Owner, Maillefer Instruments
`
`Holding S.a.r.l., has a related pending patent application that might be affected by
`
`this proceeding: U.S. Pat. Appl. Ser. No. 15/710,869. Petitioner has also filed IPR
`
`petitions for the other three patents at issue in the district court case. See Case Nos.
`
`IPR2018-001320, -01321, and -01322. While such patents are not in the same
`
`1
`
`

`

`
`
`family as the '696 patent, the subject matter is similar and Petitioner relies on
`
`common prior art references in support of its unpatentability positions. 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. §42.83(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 '696 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 '696 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, 2, 5, and 8-10 of the '696 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. No. 2004/0023186 to
`McSpadden ("McSpadden," Ex. 1004)
`
`
`Ground 2
`Obviousness over McSpadden
`
`
`Ground 3
`Obviousness over McSpadden in view of U.S. Pat. No.
`6,299,445 to Garman ("Garman," Ex. 1005)
`
`
`Ground 4
`Obviousness over U.S. Pat. Appl. No. 2006/0228669 to
`Scianamblo ("Scianamblo," Ex. 1006)
`
`
`Ground 5
`Obviousness over Scianamblo in view of Garman
`
`
`
`Challenged Claims
`
`1, 2, 5, 8
`
`
`
`1, 2, 5, 8, 10
`
`Challenged Claims
`
`9
`
`Challenged Claims
`
`1, 2, 5, 8, 10
`
`Challenged Claim
`
`9
`
`3
`
`

`

`
`
`Ground 6
`Obviousness over WO 01/19279 to Badoz ("Badoz," Exs.
`1007 and 1008)1 in View of U.S. Pat. No. 5,882,198 to
`Taylor et al. ("Taylor," Ex. 1009)
`
`
`Ground 7
`Obviousness over Badoz in view of Taylor and in further
`view of Garman
`
`
`Challenged Claims
`
`1, 2, 5, 10
`
`Challenged Claims
`
`8, 9
`
`
`For purposes of this IPR only, Petitioner assumes that the earliest effective
`
`filing date of the '696 patent is January 30, 2013, which is the filing date for
`
`PCT/IB2013/000108, to which the '696 patent claims priority. 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).
`
`Scianamblo published on October 12, 2006, 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).
`
`Taylor issued on March 16, 1999, 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).
`
`1 Exhibit 1007 is the original references in the French language. Exhibit 1008 is the
`
`certified translation. Citations herein are to the latter.
`
`4
`
`

`

`
`
`IV. BACKGROUND AND SUMMARY OF THE '696 PATENT
`
`A. Overview of the '696 Patent
`
`The '696 patent relates to an instrument for drilling dental root canals. Ex.
`
`1001, 2:15-16; Ex. 1003, ¶¶33.2 The '696 patent identifies two drawbacks with a
`
`conventional instrument. Ex. 1001, 1:25-33; Ex. 1003, ¶33. First, it "may have a
`
`tendency to screw itself into the canal." Ex. 1001, 1:25-26; Ex. 1003, ¶33. Second,
`
`it is either too flexible, resulting in bending or breaking of the instrument, or too
`
`rigid, resulting in difficulty in the instrument following the curvature of the root
`
`canal. Ex. 1001, 1:29-33; Ex. 1003, ¶33.
`
`The '696 patent attempts to address the alleged drawbacks associated with
`
`instruments for drilling dental root canals. Ex. 1003, ¶¶34, 35. In one embodiment,
`
`it describes an instrument comprising a rod fitted with a handle that permits
`
`actuation of the instrument either manually or in a hand-held device that drives the
`
`instrument. Ex. 1001, 2:56-62; Ex. 1003, ¶36. The rod has an active part that is
`
`preferably tapered and conical, narrowing to a point. Ex. 1001, 2:63-67; Ex. 1003,
`
`¶36. The active part has a square cross-section forming four cutting edges. Ex.
`
`1001, 3:1-7; Ex. 1003, ¶36. The active part is defined by an envelope that is
`
`substantially tapered and has its longitudinal axis coinciding with the instrument's
`
`
`2 Citations are to the column and line number for patents, and either paragraph
`
`number or page and line numbers for other patent publications.
`
`5
`
`

`

`
`
`rotational axis. Ex. 1001, 3:7-10; Ex. 1003, ¶36.
`
`
`
`As illustrated in Figures 1-4 (reproduced below), the "active part 1b has a
`
`first portion 1c extending from the point 3 towards the rear of the active part 1b
`
`and of which the centre of mass is located on the axis of rotation R of the
`
`instrument and a second portion 1d extending from the end of the first portion 1c to
`
`the rear of the active part 1b and of which at least one cross-section has a centre of
`
`mass which is not located on the axis of rotation R of the instrument but is offset
`
`with respect to said axis R." Ex. 1001, 3:11-48; Ex. 1003, ¶¶37-38. Preferably, for
`
`any cross-section 4b of the second portion 1d, a single cutting edge is 5a located on
`
`the envelope 7, while the other cutting edges 5b, 5c and 5d are located inside the
`
`envelope 7. Ex. 1001, 3:37-42; Ex. 1003, ¶38.
`
`
`
`6
`
`

`

`
`
`Ex. 1001, Figs. 1-4.
`
`The '696 patent discloses a second embodiment, which is similar to the first,
`
`Ex. 1001, 4:22-50, except that for any cross-section of the second portion, two
`
`cutting edges are located on the envelope, and two cutting edges are located inside
`
`the envelope, Ex. 1001, 4:50-55; Ex. 1003, ¶¶40-41.
`
`In a third disclosed embodiment, the active part has cross-sections of a
`
`parallelogram shape, and the second portion of the active part has an alternating
`
`arrangement of zones that have off-center cross-sectional centers of mass and
`
`zones that have centered cross-sectional centers of mass. Ex. 1001, 4:62-5:32,
`
`6:46-59; Ex. 1003, ¶¶42-44. Preferably, the off-center zones have one cutting edge
`
`on the envelope, while the centered zones have two cutting edges on the envelope.
`
`Ex. 1001, 5:38-51; Ex. 1003, ¶44.
`
`B.
`
`Prosecution History of the '696 Patent
`
`While McSpadden, Scianamblo and Badoz were identified in an Information
`
`Disclosure Statement submitted during prosecution of the application that resulted
`
`in issuance of the '696 patent, U.S. Pat. Appl. Ser. No. 14/651,677 (the '677
`
`application"), they were never discussed.3 A reference related to McSpadden,
`
`
`3 Notably, McSpadden, Scianamblo, and Badoz were disclosed in an Information
`
`Disclosure Statement that identified 46 references and that was submitted after an
`
`original notice of allowance had already issued. Ex. 1002, pp. 321-325, 350-356.
`
`7
`
`

`

`
`
`however, was discussed during prosecution. But, as noted below, key disclosures
`
`in that reference appear to have been overlooked. Grounds 1-3 of this Petition are
`
`based on these critical disclosures and present arguments and supporting testimony
`
`not previously considered by the United States Patent and Trademark Office
`
`("PTO").
`
`In a non-final office action, dated January 30, 2017, the examiner rejected
`
`then-pending claims 1-7, 9, and 10 under 35 U.S.C. §102(b) as anticipated by U.S.
`
`Pat. Appl. Pub. No. 2006/0228668 (Ex. 1010, "the related McSpadden reference")4
`
`and then-pending claim 8 as rendered obvious by the related McSpadden reference.
`
`Ex. 1002, pp. 245-249. The examiner referenced portions of the related
`
`McSpadden reference that correspond to Figures 3A, 3C, 3D, and 4A-4I and
`
`Paragraph 58 of McSpadden, Ex. 1002, pp. 245-247, 249, but did not cite or refer
`
`to several key disclosures that correspond to those of McSpadden upon which
`
`Petitioner relies in this Petition, e.g., Ex. 1004, ¶¶36, 49, 51-53, 59, and 60, which
`
`are discussed in detail below. See infra Sections VII.B. and VII.C. (Grounds 1-3).
`
`In an April 26, 2017 response, the applicants argued that "McSpadden does
`
`not disclose or suggest that an active part terminates by a point and is defined by
`
`an envelope of a cylindrical or conical shape along its entire length" and that
`
`
`4 The related McSpadden reference is a continuation-in-part of, and in substantial
`
`part includes the disclosures of, McSpadden. Compare Ex. 1004 with Ex. 1010.
`
`8
`
`

`

`
`
`"McSpadden does not disclose or suggest a tapered rod having a single continuous
`
`taper function." Ex. 1002, pp. 315-316. Thereafter, the claims were allowed.
`
`In advancing these arguments, the applicants misunderstood and/or
`
`misrepresented the teachings of the related McSpadden reference. Notably, the
`
`applicants discussed and attempted to distinguish only the embodiment depicted in
`
`Figures 2A and 2C of the related McSpadden reference, while ignoring the
`
`remainder of the reference, including Figures 3A and 3C (which correspond to
`
`Figures 3A and 3C of McSpadden) and the descriptions of the embodiment
`
`depicted therein. With respect to that embodiment, as discussed in detail below,
`
`McSpadden clearly discloses "a tapered rod defined by a single continuous taper
`
`function," as well as an "active part terminating by a point and being defined by an
`
`envelope of a cylindrical or conical shape along its entire length." See infra
`
`Sections VI.A. and VII.B.1.
`
`For at least the foregoing reasons, none of the grounds in this Petition raises
`
`"substantially the same" arguments previously considered by the PTO. The
`
`unpatentability arguments presented in this Petition are based on disclosures in the
`
`identified references that have never been addressed by the PTO, and are
`
`accompanied by new evidence, including the declaration of Gary Garman, that
`
`confirms the unpatentability of the challenged claims. Accordingly, the Board
`
`should decline to exercise its discretion under 35 U.S.C. §325(d), and should
`
`9
`
`

`

`
`
`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.
`
`at 27 (PTAB Oct. 25, 2017) (Paper 9).
`
`V. LEVEL OF ORDINARY SKILL IN THE ART
`
`The art to which the '696 patent relates is the field of endodontic
`
`instruments. Ex. 1001, 1:7-8, 2:15-16. A person of ordinary skill in the art as of
`
`January 2013 (a "POSITA") would have had at least a Bachelor's degree in
`
`mechanical engineering or a related field, and at least two years of work
`
`experience in the design and/or operation of endodontic instruments so as to
`
`understand the characteristics of the same. Ex. 1003, ¶¶65-66.
`
`VI. CLAIM CONSTRUCTION (37 C.F.R. §42.104(B)(3))
`
`A claim subject to IPR is to be given its broadest reasonable construction in
`
`light of the specification. 37 C.F.R. §42.100(b); Cuozzo Speed Techs., LLC v. Lee,
`
`136 S. Ct. 2131 (2016). Petitioner submits, for the purposes of this proceeding
`
`only, the following claim constructions.5
`
`
`5 Petitioner may seek additional and/or alternate claim constructions in district
`
`10
`
`

`

`
`
`A.
`
`"a tapered rod defined by a single continuous taper function"
`
`Claim 1 recites that the claimed instrument has "a tapered rod defined by a
`
`single continuous taper function." To a POSITA, "taper" generally means the
`
`change of the diameter of an instrument per unit length of the file. Ex. 1003, ¶49.
`
`A typical endodontic instrument has, across the length of its tapered portion, a
`
`gradual decrease in the diameter of the instrument, i.e., a continuous taper. Ex.
`
`1003, ¶50.This gives such an instrument a uniform, conical shape from a profile
`
`view. Id.
`
`The '696 patent specification does not discuss the concept of "a single
`
`continuous taper function." In fact, this phrase is not even mentioned in the
`
`specification. As noted above, see supra Section IV.B., during prosecution of the
`
`'677 application, the examiner rejected then-pending claims 1-7, 9, and 10 under 35
`
`U.S.C. §102(b) as anticipated by the related McSpadden reference, Ex. 1002, pp.
`
`245-247, and rejected then-pending claim 8 as rendered obvious by the related
`
`McSpadden reference, Ex. 1002, 249. In response, the applicant added the words
`
`"defined by a single continuous taper function" to claim 1 in an attempt to
`
`distinguish it from the embodiment depicted in Figures 2A and 2C of the related
`
`
`court. Further, Petitioner does not concede that the challenged claims are definite,
`
`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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`11
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`McSpadden reference. In that embodiment, the diameter of the instrument gets
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`smaller, but the contours of the instrument are defined by an undulating shape that
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`bulges inward and outward. Ex. 1010, Figs. 2A-2B; Ex. 1003, ¶¶51-52.
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`The related McSpadden reference explains that in such embodiment the
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`envelope is defined by a "a second taper function—different from the first—that
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`preferably varies from a positive taper angle (α2) to negative taper angle (α3)." Ex.
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`1010, ¶34; Ex. 1003, ¶53. This results in an instrument that has a diameter that
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`"alternatingly expands and contracts from the proximal end 107 to the distal end
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`108 within an envelope defined by the first and second taper functions while
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`remaining essentially concentric with the central axis 115 of the instruments 00."
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`Ex. 1010, ¶40; Ex. 1003, ¶53. As shown in Figures 2A and 2C of the related
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`McSpadden reference (reproduced below with annotations in red), the instrument's
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`diameter alternatingly contracts and expands towards the tip end.
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`12
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`Ex. 1003, ¶53. The taper of this embodiment is therefore not defined by a single
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`function that tapers continuously, as the taper is disrupted by portions of the
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`instrument that bulge outward. Id.
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`In contrast, the embodiment depicted in Figures 3A and 3C of the related
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`McSpadden reference, has a diameter that tapers substantially continuously from
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`one end of the working portion toward the tip end:
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`13
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`Ex. 1003, ¶¶54-56. Therefore, Figures 3A and C depict a "tapered rod defined by a
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`single continuous taper function," notwithstanding that the related McSpadden
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`reference describes this embodiment as having a second taper function (which
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`defines its "cork-screw-like shape"). Ex. 1010, ¶¶48-54, 56; Ex. 1003, ¶¶54-56.
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`"A tapered rod defined by a single continuous taper function" would not, to
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`a POSITA, mean simply that the entire shape of the instrument is defined by only a
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`single taper function. Ex. 1003, ¶¶57-58. An endodontic instrument defined
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`entirely by a single taper function would be flat and simply narrow to a point,
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`similar to a nail or toothpick. Ex. 1003, ¶57. However, the embodiments described
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`in the '696 patent have a decreasing taper, a polygonal cross-sectional shape and,
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`14
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`just like in Figures 3A and 3C of the related McSpadden reference, a corkscrew
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`shape that winds in a sinusoidal manner across the length of the active part of the
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`instrument. Id. at ¶59.
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`
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` Ex. 1001, Fig. 1.
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`
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` Ex. 1010, Ex. 3A.
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`Accordingly, the term "a tapered rod defined by a single continuous taper
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`function" should be construed as "a rod having a diameter that gets gradually
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`smaller toward one end." Ex. 1003, ¶60.
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`B.
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`"a polygonal cross-section"
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`Claim 1 further recites that the tapered rod has "over at least an active part of
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`15
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`its length a polygonal cross-section forming at least two cutting edges." The
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`specification states: "The embodiments presented above describe polygonal cross-
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`section with straight sides. It is clear that said sides could be curved. Consequently,
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`the term 'polygonal' should be understood in its general sense meaning 'which has a
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`plurality of sides' and covering equally a geometric shape with straight or curved
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`sides." Ex. 1001, 6:65-7:3; Ex. 1003, ¶61. Thus, "a polygonal cross-section" should
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`be construed as "a cross-section having a geometric shape with a plurality of
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`straight or curved sides." Id.
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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 attempts to solve the same problems identified in the '696 patent
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`and the other prior art references discussed herein. Ex. 1004, ¶33, 60, 61; Ex. 1003,
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`¶69. Endodontic files having twisting or helically spiraling cutting edges 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, 10, 11, 13, 33, 44, 61;
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`Ex. 1003, ¶70. McSpadden and the '696 patent are both concerned with increasing
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`the flexibility of the instrument, without sacrificing overall strength. Ex. 1004,
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`16
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`¶¶44, 60; Ex. 1003, ¶¶71-72. McSpadden additionally identifies the problem of
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`heavy torque loading caused by inefficient cutting or high surface area engagement
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`of the file with the inner canal wall, leading to "catastrophic failure." Ex. 1004, ¶8,
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`10, 44, 60; Ex. 1003, ¶72.
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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, ¶73. 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, ¶73.
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`In one embodiment, depicted in Figures 3A through 3D, the corners of the
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`shaft assume a helical or spiraling shape. Ex. 1004, ¶13; Ex. 1003, ¶74.
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`17
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`Ex. 1004, Fig. 3A.
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`
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`McSpadden explains that the second taper function modulates the center axis
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`of the cross-sectional polygon (e.g., triangular or square) relative to the central axis
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`of the instrument such that the cross-sectional polygon 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; Ex. 1003, ¶74; see also Ex. 1003,
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`¶63.
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`McSpadden further explains that "[t]hose skilled in the art will readily
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`appreciate that a wide variety of alternative taper functions and cross-sections
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`18
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`having various constant or non-constant phase angles, wave lengths and
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`frequencies may be used and combined together to produce any variety of desired
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`performance characteristics." Ex. 1004, ¶64; Ex. 1003, ¶75. McSpadden also
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`teaches that "[t]he tip 150 of the instrument 100 may assume any number of a
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`variety of possible configurations (e.g., chisel, cone, bullet, multifaceted and/or the
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`like), depending upon the preference of the endodontist and manufacturing
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`conveniences." Ex. 1004, ¶42; Ex. 1003, ¶76.
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`2.
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`Scianamblo
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`Scianamblo's goal, similar to that of the '696 patent and the other prior art
`
`references discussed herein, is to create instruments that "can provide more
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`efficient endodontic cleaning which is safer for a patient. An instrument that is
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`both flexible and strong resists breaking and injuring the patient." Ex. 1006, ¶27;
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`Ex. 1003, ¶77; see also Ex. 1006, ¶58.
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`Scianamblo broadly describes endodontic instruments for treatment of root
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`canals, which are known as endodontic cavity spaces, or ECS. Ex. 1006, ¶112; Ex.
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`1003, ¶78. Scianamblo describes a number of variations on the shape and geometry
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`of endodontic instruments that, according to Scianamblo, "swagger," i.e., move in
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`a wave-like manner, when used in an endodontic cavity. Ex. 1006, ¶¶109-112, 199;
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`Ex. 1003, ¶¶78-82. Scianamblo describes the behavior of these files: "[W]hen the
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`center of mass of the system corresponds to the axis [of] rotation, the system is in
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`19
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`
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`equilibrium and the instrument turns evenly around the axis. When the center of
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`mass or the centroid [of] the system is at a distance from the center of rotation,
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`similar to an endodontic instrument of singly symmetric cross section, the system
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`is out of equilibrium and will tend to swagger." Ex. 1006, ¶125; Ex. 1003, ¶80.
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`Figure 31A depicts the endodontic instrument described in Scianamblo "at
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`two different locations at two different points in time while the instrument rotates."
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`Ex. 1006, ¶235; Ex. 1003, ¶¶83-84.
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`Ex. 1006, Fig. 31A. The rotating instrument presents "a mechanical wave 2420, or
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`multiples of a half of a mechanical wave" pattern when the instrument is rotated
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`20
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`that "may appear to form helical waves that propagate up and down within the
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`canal." Ex. 1006, ¶235; Ex. 1003, ¶84. These waves propagate in three dimensions
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`in the ECS. Ex. 1006, ¶235; Ex. 1003, ¶84. "As the wave propagates, different
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`portions of the instrument extend from the axis of rotation varying amounts (not
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`shown) and may appear as a spiraling body to a human viewer when the instrument
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`is rotating very fast." Ex. 1006, ¶235; Ex. 1003, ¶84.
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`Scianamblo's endodontic instruments can be formed with a cutting tip. Ex.
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`1006, Figs. 22A-22D; ¶49; Ex. 1003, ¶85. Figure 27 depicts a file with an offset
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`center of mass. Ex. 1003, ¶85. Scianamblo teaches that the offset center of mass
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`and cutting tip features can be combined. Ex. 1006, ¶233; Ex. 1003, ¶85.
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`Moreover, Scianamblo explains that the instrument shown in Figure 27 can display
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`"a change in cross section geometry" such that the