`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`____________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`EDGE ENDO, LLC,
`Petitioner
`
`v.
`
`MICHAEL SCIANAMBLO,
`Patent Owner
`____________________
`
`Case No. IPR2018-01322
`U.S. Patent No. 9,351,803
`____________________
`
`
`
`
`
`
`
`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.
`
`Related Matters (37 C.F.R. §42.8(b)(2)) ............................................... 1
`
`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)) ..................................................... 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 '803 PATENT ...................... 5
`
`A. Overview of the '803 Patent .................................................................. 5
`
`B.
`
`Prosecution History of the '803 Patent .................................................. 6
`
`V.
`
`LEVEL OF ORDINARY SKILL IN THE ART ............................................. 9
`
`VI. CLAIM CONSTRUCTION (37 C.F.R. §42.104(B)(3)) ................................. 9
`
`A.
`
`"asymmetrical" .................................................................................... 10
`
`B.
`
`"polygonal shape" ................................................................................ 12
`
`VII. DETAILED EXPLANATION OF UNPATENTABILITY GROUNDS ..... 12
`
`A. Overview of the Prior Art .................................................................... 12
`
`1. McSpadden ................................................................................. 12
`
`2. Rouiller ....................................................................................... 14
`
`
`
`i
`
`

`

`3. Badoz .......................................................................................... 15
`
`4. Garman ....................................................................................... 16
`
`B. Ground 1: Claims 1, 3-6, 10-12, 15-17, and 21 are Anticipated by
`McSpadden Ground 2: Claim 10 is Obvious over McSpadden .......... 18
`
`1.
`
`Independent claim 1 ................................................................... 18
`
`2. Dependent claim 3 ...................................................................... 28
`
`3. Dependent claim 4 ...................................................................... 30
`
`4. Dependent claims 5, 6, 17, and 21 ............................................. 30
`
`5. Dependent claim 10 .................................................................... 31
`
`6. Dependent claim 11 .................................................................... 32
`
`7. Dependent claim 12 .................................................................... 33
`
`8. Dependent claim 15 .................................................................... 33
`
`9. Dependent claim 16 .................................................................... 34
`
`C. Ground 3: Dependent Claims 13, 14, and 20 are Rendered Obvious
`Over McSpadden in View of Garman ................................................. 35
`
`D. Ground 4: Claims 1, 3-6, 10-11, 16, 17, and 21 are Anticipated by
`Rouiller Ground 5: Claim 10 is Obvious over Rouiller ...................... 38
`
`1.
`
`Independent claim 1 ................................................................... 38
`
`2. Dependent claim 3 ...................................................................... 43
`
`3. Dependent claim 4 ...................................................................... 45
`
`4. Dependent claims 5, 6, 17, 21 .................................................... 45
`
`5. Dependent claim 10 .................................................................... 46
`
`6. Dependent claim 11 .................................................................... 47
`
`7. Dependent claim 16 .................................................................... 47
`
`
`
`ii
`
`

`

`E.
`
`Ground 6: Dependent claims 12-15 and 20 are Rendered Obvious
`by Rouiller in View of Garman ........................................................... 48
`
`1. Dependent claims 12-14 and 20 ................................................. 48
`
`2. Dependent claim 15 .................................................................... 50
`
`F.
`
`Ground 7: Claims 1, 3-4, 10-12, and 16-17 are Obvious Over
`Badoz ................................................................................................... 50
`
`1.
`
`Independent claim 1 ................................................................... 51
`
`2. Dependent claim 3 ...................................................................... 56
`
`3. Dependent claim 4 ...................................................................... 57
`
`4. Dependent claim 10 .................................................................... 58
`
`5. Dependent claim 11 .................................................................... 59
`
`6. Dependent claims 12 and 17 ...................................................... 59
`
`7. Dependent claim 16 .................................................................... 60
`
`G. Ground 8: Dependent claims 5-6, 13-15, and 20-21 are Rendered
`Obvious by Badoz in View of Garman ............................................... 60
`
`1. Dependent claims 5, 6, and 21 ................................................... 61
`
`2. Dependent claims 13, 14, and 20 ............................................... 62
`
`3. Dependent claim 15 .................................................................... 63
`
`H. No Secondary Considerations of Non-obviousness ............................ 64
`
`VIII. CONCLUSION .............................................................................................. 64
`
`
`
`
`
`
`
`
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`Acclarent, Inc. v. Ford Albritton, IV,
`Case IPR2017-00498, slip op. (PTAB July 10, 2017).......................................... 8
`
`Alcon Research, Ltd. v. Apotex Inc.,
`687 F.3d 1362 (Fed. Cir. 2012) .......................................................................... 56
`
`Amneal Pharms., LLC v. Supernus Pharms., Inc.,
`IPR2013-00368, slip op. (P.T.A.B. Dec. 17, 2013) ........................................... 64
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .......................................................................................... 9
`
`Edwards Lifesciences Corp. v. Boston Scientific Scimed Inc.,
`Case IPR2017-01295, slip op. (PTAB Oct. 25, 2017) ......................................... 9
`
`Google Inc. v. Blackberry Ltd.,
`Case IPR2017-00914, slip op. (PTAB Sept. 11, 2017) ........................................ 9
`
`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)........................................... 8
`
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) .......................................................................... 57
`
`Statutes
`
`35 U.S.C. §102 ....................................................................................................... 3-5
`
`35 U.S.C. §103 ........................................................................................................... 3
`
`35 U.S.C. §325 ........................................................................................................... 8
`
`
`
`iv
`
`

`

`Exhibit No.
`1001
`1002
`1003
`1004
`1005
`1006
`1007
`
`1008
`1009
`
`1010
`
`1011
`1012
`1013
`
`1014
`1015
`1016
`1017
`
`EXHIBIT LIST
`
`Description
`U.S. Patent No. 9,351,803 to Scianamblo
`File History of U.S. Patent No. 9,351,803
`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.
`The Concise Oxford Dictionary of Mathematics (4th ed.) (excerpt)
`
`
`
`
`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, 3-6, 10-17, and 20-21 ("the challenged claims") of U.S. Patent No. 9,351,803
`
`(Ex. 1001, "the '803 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 '803 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. 8,882,504 (Case No. IPR2018-01320) and 8,932,056
`
`(Case No. IPR2018-01321), 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 '803 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 '803 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, 3-6, 10-17, and 20-21 of the '803 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
`Ground 3
`Obviousness over McSpadden in view of U.S. Pat. No.
`6,299,445 ("Garman," Ex. 1005)
`Ground 4
`Anticipation by WO 02/065938 ("Rouiller," Exs. 1006,
`
`Challenged Claims
`1, 3-6, 10-12, 15-17,
`21
`Challenged Claim
`10
`Challenged Claims
`
`13-14, 20
`
`Challenged Claims
`1, 3-6, 10-11, 16, 17,
`
`3
`
`

`

`1007)1
`
`Ground 5
`Obviousness over Rouiller
`Ground 6
`Obviousness over Rouiller in view of Garman
`Ground 7
`Obviousness over WO 01/19279 ("Badoz," Exs. 1008,
`1009)1
`
`21
`Challenged Claim
`10
`Challenged Claims
`12-15, 20
`Challenged Claims
`1, 3-4, 10-12, 16-17
`
`Ground 8
`Obviousness over Badoz in view of Garman
`
`For purposes of this proceeding only, Petitioner assumes that the earliest
`
`Challenged Claims
`5-6, 13-15, 20-21
`
`effective filing date of the '803 patent is April 8, 2005, which is the filing date for
`
`U.S. Provisional Application No. 60/669,409, to which the '803 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).
`
`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).
`
`
`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.
`
`4
`
`

`

`Badoz published on March 22, 2001, and thus qualifies as prior art under
`
`pre-AIA 35 U.S.C. §102(b).
`
`IV. BACKGROUND AND SUMMARY OF THE '803 PATENT
`
`A. Overview of the '803 Patent
`
`The '803 patent relates to endodontic instruments, and specifically,
`
`endodontic instruments that "have at least a section with a center of mass offset
`
`from an axis of rotation." Ex. 1001, Abstract. The '803 patent specification
`
`describes "methods and apparatus for providing swaggering endodontic
`
`instruments for preparing an endodontic cavity space." Ex. 1001, 1:20, 3:57-59;
`
`Ex. 1003, ¶¶30-35.2
`
`Used throughout the patent specification but not recited in the claims,
`
`"swagger" is not a conventional term in the relevant art. See infra Section VI.A.
`
`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, 18:48-50; Ex. 1003, ¶35. The '803 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, 18:51-54; Ex.
`
`
`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
`
`

`

`1003, ¶35. A wave pulse would travel along the length of the rope, and the
`
`amplitude of the wave would vary sinusoidally. Ex. 1001, 18:56-19:3; Ex. 1003,
`
`¶¶35-36.
`
`The '803 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
`
`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, ¶¶37-44.
`
`According to the '803 patent, since these instruments have fewer cutting
`
`edges in contact with the endodontic cavity wall at any given time, they are less
`
`susceptible to certain problems encountered during use of endodontic instruments
`
`in endodontic procedures, such as binding with the endodontic cavity wall and
`
`breakage caused by heavy torque loading. See, e.g., Ex. 1001, 6:4-7, 7:19-24, 8:63-
`
`67, 9:49-51; Ex. 1003, ¶¶25, 27, 33.
`
`B.
`
`Prosecution History of the '803 Patent
`
`While McSpadden was discussed during prosecution of the application that
`
`resulted in the issuance of the '803 patent, U.S. Pat. Appl. Ser. No. 14/632,930
`
`("the '930 application"), key disclosures appear to have been overlooked. And,
`
`6
`
`

`

`while Garman and references related to Rouiller and Badoz were identified, Ex.
`
`1001, p. 2, none of these references was discussed.3 As set forth below, this
`
`Petition is based on critical disclosures in the identified prior art references, and
`
`presents arguments and supporting expert testimony not previously considered by
`
`the United States Patent and Trademark Office ("PTO").
`
`In a non-final rejection dated September 30, 2015, the examiner rejected
`
`claims 2-7, 10, 12, 16-18, and 21 of the '930 application under 35 U.S.C. §102 as
`
`anticipated by McSpadden. Ex. 1002, pp. 159-161. The examiner also rejected
`
`claim 3 under 35 U.S.C. §103 as rendered obvious over two references not at issue
`
`here—Lovaas (U.S. Patent No. 4,889,487) and Wagner (U.S. Patent No.
`
`6,890,134)—in view of McSpadden's disclosure of a reverse helix. Ex. 1002, p.
`
`164. Against these claims, the examiner cited Figures 3A, 3C, 3D, 4D, 4I, 5A, 5B,
`
`and paragraphs 45, 47, 48, 52, of McSpadden. Ex. 1002, pp. 159-161, 164.
`
`Notably, the examiner did not refer to key disclosures from McSpadden upon
`
`which Petitioner relies herein, e.g., Ex. 1004, ¶¶49, 50-51, 53, 58, 59, 60-61, and
`
`63-64, and which are discussed in detail below. See infra Section VII.B.1.
`
`After an interview with the examiner, Ex. 1002, p. 184, in a December 17,
`
`3 Garman and the related Rouiller and Badoz references were identified in a
`
`February 26, 2015 Information Disclosure Statement along with 69 other
`
`references. Ex. 1002, pp. 102-104.
`
`7
`
`

`

`2015 response, applicant amended the claims, by merely replacing "revolves" with
`
`"spirals" and specifying that the center of math path spirals around the first axis
`
`(i.e., axis of rotation) "along a length of the first axis." Ex. 1002, p. 190. Applicant
`
`argued tersely that McSpadden does not disclose "wherein at least a portion of the
`
`center of mass path between the tip end and the shank end spirals around the first
`
`axis along a length of the first axis" and instead discloses "a center of mass path
`
`that 'follows a periodic or repeating function, such as a sine function, cosine
`
`function or the like.'" Ex. 1002, pp. 194-196. In so doing, applicant ignored the
`
`clear teachings of this reference, which, as discussed below (see infra Section
`
`VII.B.1.vi), disclose this claimed limitation.
`
`For 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 and/or combinations that have never been addressed by the
`
`PTO and are accompanied by new evidence, including the declaration of
`
`Petitioner's expert, Gary Garman, which 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 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,
`
`8
`
`

`

`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 '803 patent relates is the field of endodontic
`
`instruments. Ex. 1001, 1:20. A person of ordinary skill in the art as of April 2005
`
`(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. Ex. 1003, ¶¶57-58.
`
`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 provides below, for the purposes of this
`
`proceeding only, the construction of two claim terms applying this standard.4
`
`
`4 Petitioner may seek additional and/or alternate claim constructions in the related
`
`district court litigation. 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 to the prior art as described herein.
`
`9
`
`

`

`A.
`
`"asymmetrical"
`
`Claim 12 recites that "the plurality of transverse cross-sections includes a
`
`transverse cross-section that is asymmetrical." There are various possible standards
`
`of symmetry. For example, a cross-section could be: singly-symmetric (i.e.,
`
`symmetric about the x-axis or y-axis); doubly-symmetric (i.e., symmetric about
`
`both axes); or rotationally symmetric (i.e., the figure will appear the same after
`
`some rotation about its center of less than 360 degrees). Ex. 1003, ¶49. As
`
`discussed below, based on a categorization of asymmetrical and symmetrical cross-
`
`sections applied to various examples in the '803 patent specification, a POSITA
`
`would understand claim 12's recitation of "asymmetrical" to mean "not rotationally
`
`symmetric."
`
`The '803 patent explains that "an endodontic instrument with a square, or
`
`doubly symmetric cross-section rotating in the ECS [endodontic cavity space],
`
`appears to have little, if any deviation from the axis of rotation," whereas "[a]n
`
`instrument with a singly symmetric (trapezoidal or triangular) cross section" acts
`
`like a rope with an excitation force or forces applied along the y and z-axes, or one
`
`with an excitation force along the y-axis and a lateral force applied somewhere
`
`along its length." Ex. 1001, 19:19-26; Ex. 1003, ¶49. The '803 patent further
`
`explains that an endodontic instrument of singly symmetric cross section "is out of
`
`equilibrium and will tend to swagger." Ex. 1001, 20:34-38; Ex. 1003, ¶49.
`
`10
`
`

`

`The '803 patent then provides comparisons of symmetrical and asymmetrical
`
`cross-sections: a square (symmetrical) and a triangle (which may be asymmetrical),
`
`Ex. 1001, 30:6-11; an equilateral triangle (symmetrical) and an isosceles triangle
`
`(asymmetrical), id. at 36:9-42; a square (symmetrical) and trapezoid
`
`(asymmetrical), id.; and a rectangle (symmetrical) and a triangular (which may be
`
`asymmetrical), id. at 36:43-57. Ex. 1003, ¶50.
`
`In sum, the specification identifies three shapes as symmetrical: a square, a
`
`rectangle, and an equilateral triangle. Ex. 1001, 30:6-11, 36:9-42, 36:43-57; Ex.
`
`1003, ¶51. Since an equilateral triangle is not doubly-symmetric, double-symmetry
`
`does not appear to be the standard the '803 patent is using. Ex. 1003, ¶51. The
`
`specification also identifies three shapes as asymmetrical: a trapezoid, a triangle
`
`(presumably, one that is not equilateral), and an isosceles triangle. Ex. 1001, 30:6-
`
`11, 36:9-42, 36:43-57; Ex. 1003, ¶51. Since these shapes are generally singly-
`
`symmetric, single-symmetry also does not appear to be the symmetry standard the
`
`'803 patent is using. Ex. 1003, ¶51. The standard of symmetry that is consistent
`
`with these categorizations is that of rotational symmetry. Id. Under this standard: a
`
`square and a rectangle are symmetric, a trapezoid is not, and a triangle may or may
`
`not be symmetric (an equilateral triangle is, but an isosceles triangle is not). Id.
`
`Accordingly, "asymmetrical" should be construed as "not rotationally
`
`symmetric." Ex. 1003, ¶¶48-52.
`
`11
`
`

`

`B.
`
`"polygonal shape"
`
`Claim 17 recites that "each transverse cross-section of the body is defined by
`
`a polygonal shape." Claim 20 recites that "a ratio of lengths of sides of the
`
`polygonal shape vary along the length of the body." The specification describes
`
`cross-sections of an endodontic instrument having one of various multi-sided
`
`shapes, including, among others, triangular and rectangular. Ex. 1001, 31:38-55,
`
`31:63-65, 33:18-20, 34:41-43, 36:17-25, 36:48-59. Numerous figures in the '803
`
`patent depict a cross-sectional shape without straight sides. Ex. 1001, Fig. 7D, 8B,
`
`9H, 21D, 21E, 22A-22D, 23D, 24D, 24E, 25D, 25E, 27A-27C, 28A, 28B, 29A,
`
`29B. Ex. 1003, ¶53. Further, the specification states: "The term polygon
`
`approximates the shape and is not meant to indicate that the sides necessarily are
`
`linear." Ex. 1001, 36:57-59; Ex. 1003, ¶53. Accordingly, "polygonal shape" should
`
`be construed as "a shape approximating a polygon with sides that are not
`
`necessarily linear." Ex. 1003, ¶53.
`
`VII. DETAILED EXPLANATION OF UNPATENTABILITY GROUNDS
`
`The challenged claims are unpatentable in view of the prior art for the
`
`reasons discussed below.
`
`A. Overview of the Prior Art
`
`1. McSpadden
`
`McSpadden discloses that a problematic aspect of conventional endodontic
`
`files having twisting or helically spiraling cutting edges is that they often bind
`
`12
`
`

`

`with, or burrow into, the root canal, potentially causing the file to inadvertently
`
`drive deep into the root canal, to puncture the apical seal of the canal, and to
`
`otherwise transport through the canal wall. Ex. 1004, ¶¶8, 33; Ex. 1003, ¶61.
`
`Another prevalent problem described in McSpadden is heavy torque loading
`
`caused by inefficient cutting or high surface area engagement of the file with the
`
`inner canal wall, leading to "catastrophic failure." Ex. 1004, ¶8; Ex. 1003, ¶61.
`
`McSpadden discloses an endodontic file designed to alleviate the problems
`
`associated with conventional endodontic files. Ex. 1004, ¶¶60, 61;Ex. 1003, ¶61.
`
`These are the same problems that are stated to be solved by the alleged invention
`
`described in the '803 patent. See supra Section IV.A.; Ex. 1003, ¶¶25, 61.
`
`McSpadden discloses an endodontic instrument formed from a shaft having
`
`a generally twisted or fluted prismatic shape defined by three or more side surfaces
`
`and three or more interposed corners. Ex. 1004, ¶11; Ex. 1003, ¶62. The shaft
`
`includes a working portion having one or more helical cutting edges, the working
`
`portion tapered along its length in accordance with a first predetermined taper
`
`function and further tapered in accordance with a second taper function. Ex. 1004,
`
`¶11; Ex. 1003, ¶63. In one embodiment, the corners of the shaft assume a helical or
`
`spiraling shape. Ex. 1004, ¶13; Ex. 1003, ¶63. McSpadden teaches that, in this
`
`embodiment, the second taper function modulates the center axis of the polygonal
`
`(e.g., triangular or square) cross-section relative to the central axis of the
`
`13
`
`

`

`instrument such that the cross-section of the instrument winds "cork-screw-like"
`
`from the proximal end to the distal end within an envelope defined by the first and
`
`second taper functions. Ex. 1004, ¶¶52, 59, 61, 63; Ex. 1003, ¶63. The cross-
`
`sectional centers of mass of such instrument are offset from the axis of rotation.
`
`Ex. 1003, ¶63.
`
`2.
`
`Rouiller
`
`Rouiller identifies, and sets out to solve, the same problems encountered
`
`with then-existing endodontic files as those discussed above that are described in
`
`McSpadden and the '803 patent. See supra Sections IV.A. and VII.A.1; Ex. 1003,
`
`¶64. Specifically, Rouiller explains that with conventional endodontic files, the
`
`friction between the cutting edges and the walls of the canal causes significant
`
`torque applied on the file, which may cause it to break, and that conventional files
`
`are more likely to bind with the endodontic cavity wall. Ex. 1007, 1:25-26, 2:6-8,
`
`3:6-8, 3:12-15, 8:5-14; Ex. 1003, ¶64.
`
`Rouiller discloses an endodontic instrument having a base (i.e., a shank), a
`
`cutting section (i.e., a working portion), and a guiding section (i.e., a tip). Ex.
`
`1007, 5:22-23; Ex. 1003, ¶¶65-66. The instrument is either cylindrical or tapered
`
`and has a circular or polygonal (e.g., triangular or square) cross-section. Ex. 1007,
`
`5:23-30; Ex. 1003, ¶¶65-66. Rouiller teaches that an instrument with a triangular
`
`cross-section has three cutting edges defining three flutes, and that an instrument
`
`14
`
`

`

`with a square cross-section has four cutting edges defining four flutes. Ex. 1007,
`
`6:4-8, 7:18-21; Ex. 1003, ¶67. Rouiller also teaches that the axis of the envelope is
`
`moved a distance from the axis of the cutting section, such that one or more edges
`
`are set back within the envelope, and that the axis of the cutting section is
`
`helicoidal and is would up into a helix around the axis of the envelope. Ex. 1007,
`
`7:11-17; Ex. 1003, ¶68. The cross-sectional centers of mass of such instrument are
`
`offset from the axis of rotation. Ex. 1003, ¶68. 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, ¶68.
`
`3.
`
`Badoz
`
`Badoz attempts to solve the same problems as the '803 patent, McSpadden,
`
`and Rouiller, where "the forces applied during the preparation of the canal are no
`
`longer balanced and the trajectory of the instrument may deviate with respect to the
`
`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.
`
`1009, 1:15-19; Ex. 1003, ¶69. Badoz describes an endodontic instrument that
`
`alleviates these concerns by "intentionally breaking the circular symmetry of the
`
`instrument, so that the tip of the instrument is able to search for the root canal and
`
`penetrate it naturally, since the bending resistance of the blade is no longer the
`
`same in all directions." Ex. 1009, 1:21-24; Ex. 1003, ¶69.
`
`15
`
`

`

`The endodontic instrument disclosed in Badoz is "of the root-canal reamer
`
`type, comprising a working section (10) including three flutes (20, 21, 22) forming
`
`three cutting lips (30, 31, 32). It is characterized by the fact that the three cutting
`
`lips (30, 31, 32) are located at the apices of an isosceles triangle." Ex. 1009, 2:12-
`
`15; Ex. 1003, ¶¶70-71. The instrument in Badoz, "possesses a working section
`
`(10), also known as a 'blade,' whose active part is obtained by grinding and has a
`
`conical shape also obtained by grinding. Ex. 1009, 2:16-18; Ex. 1003, ¶71.
`
`4. Garman
`
`Garman, a patent granted to Petitioner's expert, teaches that conventional
`
`endodontic instruments have a tapered major diameter or cross-sectional dimension
`
`and a tapered minor diameter or cross-sectional dimension along their working
`
`portion. Ex. 1005, 1:30-52. In such instruments, the tapers of these two dimensions
`
`are generally the same, with the minor diameter being purely a function of the
`
`major diameter. Id.; Ex. 1003, ¶72. For instruments that have a greater taper along
`
`the working portion, Garman teaches that the undesirable consequences of this
`
`type of design become significant. Ex. 1005, 1:52-55; Ex. 1003, ¶72. Such
`
`instruments become much stiffer toward the proximal end of th