Filed on behalf of: Gold Standard Instruments, LLC Paper ____
`
`By:
`
` Date filed: Feb. 12, 2016
`
`
`
`Joseph A. Hynds, Lead Counsel
`Steven Lieberman, Back-up Counsel
`C. Nichole Gifford, Back-up Counsel
`R. Elizabeth Brenner-Leifer, Back-up Counsel
`Derek F. Dahlgren, Back-up Counsel
`Jason M. Nolan, Back-up Counsel
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040
`Facsimile: 202-783-6031
`Emails: jhynds@rothwellfigg.com
` slieberman@rothwellfigg.com
` ngifford@rothwellfigg.com
` ebrenner@rothwellfigg.com
` ddahlgren@rothwellfigg.com
` jnolan@rothwellfigg.com
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`v.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`_______________
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`_______________
`
`PATENT OWNER’S OBJECTIONS TO PETITIONER’S EVIDENCE
`
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`
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`

`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Gold Standard
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`Instruments, LLC, objects to the following evidence submitted by Petitioner with
`
`its Petition for Post Grant Review of U.S. Patent No. 8,876,991 B2 (Paper No. 1).1
`
`Evidence Submitted by Petitioner
`Ex. 1002 (Declaration of A. Jon
`Goldberg)
`
`Ex. 1004 (Fujio Miura et al., The
`super-elastic property of the Japanese
`NiTi alloy wire for use in orthodontics,
`90 AM. J. ORTHODONTICS &
`DENTOFACIAL ORTHOPEDICS 1
`(1986))
`Ex. 1005 (Satish B. Alapati, “An
`investigation of phase transformation
`mechanisms for nickel-titanium rotary
`endodontic instruments,” PhD thesis,
`2006)
`
`Patent Owner’s Objections
`Paragraph 104 is objected to as improper
`hearsay for which Petitioner has not
`established any exception (FRE 801) and
`is further objected to as lacking
`foundation, assuming facts not in
`evidence, containing testimony on
`matters in which the witness lacks
`personal knowledge, and/or for being
`conclusory (FRE 602, 702, 703, & 705).
`
`Paragraphs 103 and 105-107 are objected
`to for lack of authentication (FRE 901).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403), as improper
`hearsay for which Petitioner has not
`established any exception (FRE 801),
`and for lack of authentication (FRE 901).
`
`
`1 References to the Federal Rules of Evidence are denoted as “FRE.”
`2
`
`

`
`Evidence Submitted by Petitioner
`Ex. 1006 (Alan R. Pelton et al.,
`Optimisation of Processing and
`Properties of Medical-Grade Nitinol
`Wire, 9 Minimally Invasive Therapies
`& Allied Techs. 107 (2000))
`
`Ex. 1007 (U.S. Patent No. 5,697,906 to
`Ariola et al.)
`
`Ex. 1008 (Prosecution history of U.S.
`Patent No. 8,727,773)
`
`Ex. 1009 (Prosecution history of U.S.
`Patent No. 8,083,873)
`
`Ex. 1010 (Prosecution history of U.S.
`Patent No. 8,062,033)
`
`Ex. 1011 (U.S. Patent No. 8,727,773)
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`Patent Owner’s Objections
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`
`3
`
`

`
`Evidence Submitted by Petitioner
`Ex. 1012 (Prosecution history of
`European Patent Application No.
`05756629.1)
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`Ex. 1014 (International Standard ISO
`3630-1, 2nd ed. (2008))
`
`Ex. 1013 (Transcript of Motion
`Hearing, Nov. 25, 2014, Dentsply
`International, Inc. v. US Endodontics,
`LLC, Docket No. CV-2-14-196 (E.D.
`Tenn.) (excerpts))
`
`Patent Owner’s Objections
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403), as improper
`hearsay for which Petitioner has not
`established any exception (FRE 801),
`and as incomplete (FRE 106).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`Ex. 1015 (Declaration of Walter Zanes) This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`
`Ex. 1016 (Edgar Schäfer et al.,
`Bending Properties of Rotary Nickel-
`Titanium Instruments, 96 ORAL
`SURGERY ORAL MEDICINE ORAL
`PATHOLOGY 757 (2003))
`
`Ex. 1017 (Luca Testarelli et al.,
`Bending Properties of a New Nickel-
`Titanium Alloy with a Lower Percent
`by Weight of Nickel, 37 J.
`ENDODONTICS 1293 (2011))
`
`4
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`Ex. 1020 (Alan R. Pelton et al., The
`Physical Metallurgy of Nitinol for
`Medical Applications, 55 J.METALS 33-
`37 (May 2003))
`
`Ex. 1021 (S. Miyazaki et al.,
`Characteristics of Deformation and
`Transformation Pseudoelasticity in Ti-
`Ni Alloys, 43 J. PHYSIQUE
`COLLOQUES C4-255 (1982))
`
`Ex. 1025 (U.S. Patent Application
`Publication No. US 2006/0115786 A1
`to Matsutani et al.)
`
`Ex. 1019 (Excerpts of Expert Report of
`Robert Sinclair, Ph.D., Dentsply
`International, Inc. v. US Endodontics,
`LLC, Docket No. CV-2-14-196
`(E.D. Tenn.))
`
`Patent Owner’s Objections
`Evidence Submitted by Petitioner
`Ex. 1018 (Declaration of Adam Kozak) This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403), as improper
`hearsay for which Petitioner has not
`established any exception (FRE 801),
`and for lack of authentication (FRE 901).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403), as improper
`hearsay for which Petitioner has not
`established any exception (FRE 801),
`and as incomplete (FRE 106).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`
`Ex. 1026 (Japanese Unexamined Patent
`Application Publication No. 2006-
`149675, Matsutani et al.)
`
`5
`
`

`
`Evidence Submitted by Petitioner
`Ex. 1027 (English translation of
`Japanese Unexamined Patent
`Application Publication No. 2006-
`149675, Matsutani et al.)
`
`Ex. 1028 (Transmittal from prosecution
`history of U.S. Patent Application
`Serial No. 11/287,771, enclosing
`Japanese Patent Application No. 2004-
`344717 to Matsutani et al.)
`
`Ex. 1029 (Transmittal from prosecution
`history of U.S. Patent Application
`Serial No. 11/287,771, with English
`translation of enclosed Japanese Patent
`Application No. 2004-344717 to
`Matsutani et al.)
`Ex. 1031 (U.S. Patent App. Pub. No.
`2002/0137008 A1, McSpadden et al.)
`
`Ex. 1032 (Teresa Roberta Tripi et al.,
`“Fabrication of Hard Coatings on NiTi
`Instruments,” 29 J. ENDODONTICS 132
`(2003))
`
`Ex. 1033 (Harmeet Walia et al., An
`Initial Investigation of the Bending and
`Torsional Properties of Nitinol Root
`Canal Files, 14 J. ENDODONTICS
`346 (1988))
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`Patent Owner’s Objections
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403), as improper
`hearsay for which Petitioner has not
`established any exception (FRE 801),
`and for lack of authentication (FRE 901).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403), as improper
`hearsay for which Petitioner has not
`established any exception (FRE 801),
`and as incomplete (FRE 106).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403), as improper
`hearsay for which Petitioner has not
`established any exception (FRE 801),
`and as incomplete (FRE 106).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`
`6
`
`

`
`Evidence Submitted by Petitioner
`Ex. 1034 (M. G. A. Bahia, Fatigue
`Behaviour of Nickel–Titanium
`Superelastic Wires and Endodontic
`Instruments, FATIGUE & FRACTURE
`OF ENG’G MATS. & STRUCTURES
`29, 518–523 (2006))
`Ex. 1035 (Printout of the webpage:
`http://www.tulsadentalspecialties.com/
`default/endodontics/RotaryFiles/ProFil
`eISO.aspx, accessed on July 22, 2015,
`and Safety Data Sheet for Nickel
`Titanium Wire: NITINOL 55, linked on
`that webpage.)
`Ex. 1036 (Masao J. Drexel et al., The
`Effects of Cold Work and Heat
`Treatment on the Properties of Nitinol
`Wire, Proc. Int’l Conference on Shape
`Memory & Superelastic Techs., SMST-
`2006, pp. 447-454 (2008))
`Ex. 1037 (Prosecution history of U.S.
`Patent No. 8,562,341)
`
`Ex. 1038 (W.A. Brantley et al.,
`Differential Scanning Calorimetric
`Studies of Nickel Titanium Rotary
`Endodontic Instruments, 28 J.
`ENDODONTICS 567 (2002))
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`Patent Owner’s Objections
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403), as improper
`hearsay for which Petitioner has not
`established any exception (FRE 801),
`and for lack of authentication (FRE 901).
`
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`This exhibit is objected to as irrelevant to
`the grounds upon which trial has been
`instituted (FRE 401-403) and as
`improper hearsay for which Petitioner
`has not established any exception
`(FRE 801).
`
`
`
`
`The foregoing objections are made within 10 business days of the institution
`
`of the trial in accordance with 37 C.F.R. § 42.64(b)(1).
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`7
`
`

`
`Dated: February 12, 2016
`
`
`
`
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
` By: /Joseph A. Hynds /
`
`Joseph A. Hynds, Reg. No. 34,627
`ROTHWELL, FIGG, ERNST &
`MANBECK, P.C.
`607 14th St., N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040
`Facsimile: 202-783-6031
`
`Counsel for Patent Owner
`Gold Standard Instruments, LLC
`
`8
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`

`
`CERTIFICATE OF SERVICE
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`I hereby certify that on this 12th day of February 2016, a true and correct
`
`copy of the foregoing PATENT OWNER’S OBJECTIONS TO PETITIONER’S
`
`EVIDENCE was served, via electronic mail upon the following counsel for
`
`Petitioner US Endodontics, LLC:
`
`Jeffrey S. Ginsberg, Esq.
`Abhishek Bapna, Esq.
`Patterson Belknap Webb & Tyler LLP
`1133 Avenue of the Americas
`New York, NY 10036-6710
`Phone: 212-336-2630
`Facsimile: 212-336-1270
`Emails: jginsberg@pbwt.com
`abapna@pbwt.com
`
`
`
`
`
`
`
`
`/ Nasri V. Hage /
`Nasri V. Hage
`Rothwell, Figg, Ernst & Manbeck, P.C.
`
`
`
`
`
`
`
`1