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`By:
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` Paper ____
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` Date filed: Oct. 3, 2016
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`Joseph A. Hynds, Lead Counsel
`Steven Lieberman, Back-up Counsel, Pro Hac Vice
`C. Nichole Gifford, Back-up Counsel
`R. Elizabeth Brenner-Leifer, Back-up Counsel
`Derek F. Dahlgren, Back-up Counsel, Pro Hac Vice
`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
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` slieberman@rothwellfigg.com
` ngifford@rothwellfigg.com
` ebrenner@rothwellfigg.com
` ddahlgren@rothwellfigg.com
` jnolan@rothwellfigg.com
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
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`US ENDODONTICS, LLC,
`Petitioner,
`
`v.
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`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`_______________
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`_______________
`
` PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE
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`
`
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`I.
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`Introduction
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`Patent Owner opposes Petitioner’s Motion to Exclude Evidence (Paper 40).
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`Petitioner has not met its burden of establishing that it is entitled to the requested
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`relief. 37 C.F.R. §§ 42.20(c), 42.62(a). Petitioner’s motion to exclude Ex. 2034,
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`Ex. 2035, Ex. 2036, Ex. 2038, and portions of Ex. 2047 should be denied for the
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`reasons that follow.
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`II. Exhibit 2034
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`Ex. 2034 is a copy of the prosecution history for U.S. Patent Application
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`Serial No. 14/522,013 (now U.S. Patent No. 9,314,316). Petitioner argues that
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`Ex. 2034 contains inadmissible hearsay and lacks authentication. (Paper 40 at 1–3.)
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`Regarding authentication, Ex. 2034 is a record of the United States Patent
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`and Trademark Office (PTO). As such, Ex. 2034 certification is not a requirement
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`for admissibility. 37 C.F.R. § 42.61(b). Ex. 2034 is admissible in its entirety,
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`including the documents filed on March 3, 2016 (Applicant’s request for continued
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`examination, amendments to the claims, and a declaration executed by Dr. Neill H.
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`Luebke). Ex. 2034 at 372–405. Applicant’s submission refers to an Office action
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`mailed on September 4, 2015. Id. at 372. The Office action mailed on September 4,
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`2015 bears the seal of the PTO. Id. at 302. The Notice of Allowance, mailed by the
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`Case PGR2015-00019
`Patent 8,876,991 B2
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`PTO on March 14, 2016, refers to the documents filed on March 3, 2016. Id. at
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`410. It also bears the seal of the PTO. Id. at 445. Accordingly, the appearance,
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`contents, substance, internal patterns, and/or other distinctive characteristics of
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`Ex. 2034, taken together with all the circumstances, support a finding that it is
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`what Patent Owner claims it is. As such, Ex. 2034 is also admissible under Fed. R.
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`Evid. 901(a), 901(b)(4), and 902(1)(A).
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`Petitioner argues that Exhibit A to Dr. Luebke’s declaration is inadmissible
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`because there is no sworn testimony showing that Exhibit A is a true and correct
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`copy of a report prepared by Knight Mechanical Testing (KMT). (Paper 40 at 2.)
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`But testimony is not required. See Fed. R. Evid. 901 (listing testimony as one
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`example). Rule 901 also states that distinctive characteristics and the like may
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`satisfy the requirement of authenticating evidence. Exhibit A was signed by Nick
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`Chadd and Nolan Knight on March 2, 2016. Ex. 2034 at 384. Exhibit A bears KMT
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`Report No. TR1139-001 and is titled Gold Standard Nitinol Files ISO 3630-1
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`Section 7.5 Stiffness Testing Final Report. Id. Exhibit A is consecutively paginated
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`from 1/10 to 10/10. Id. at 384–393. Each page is printed on corporate letterhead,
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`which contains on the top of the page, the name Knight Mechanical Testing, the
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`stylized trade logo KMT, and the address, telephone, and fax number. Because
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`Exhibit A is signed and contains inscription affixed during the normal course of
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`business, there is no doubt as to the origin, ownership, and control of the
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`Case PGR2015-00019
`Patent 8,876,991 B2
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`document. And Petitioner has not pointed to any discrepancies or articulated any
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`reason for questioning whether Exhibit A is what it purports to be. Therefore,
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`Exhibit A is self-authenticating under Fed. R. Evid. 902(7). See, e.g., Alexander v.
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`CareSource, 576 F.3d 551, 561 (6th Cir. 2009) (job description on a company
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`letterhead was self-authenticating under Fed. R. Evid. 902(7) because it contained
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`a trade inscription indicating the source of origin of the document); Reitz v. Mt.
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`Juliet, No. 3:08-cv-0728, 2009 WL 5170200, at *5 n.7 (M.D. Tenn. Dec. 18, 2009)
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`(stating that letters and memorandum on letterhead are self-authenticating under
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`Fed. R. Evid. 902(7)).
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`Petitioner also argues that the identification, authenticity, and chain of
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`custody of the endodontic file samples tested by KMT have not been confirmed.
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`(Paper 40 at 3.) This argument ignores the record. Dr. Luebke testified that he
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`obtained nickel titanium files and instructed Bodycote Thermal Processing of
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`Sturtevant, Wisconsin to heat treat them in a furnace at 300C for 24 hours. See
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`Ex. 2034 at 382 (Luebke decl. ¶4). After the heat treatment, the files were sent to
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`KMT for testing according to ISO 3630-1. See id. (Luebke decl. ¶5). Exhibit A
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`confirms that the file samples tested by KMT were provided by Bodycote Thermal
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`Processing of Sturtevant, WI. See id. at 387 (Ex. A §3.1). Exhibit A includes photos
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`of the file samples after testing and reports the angle of permanent deformation for
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`each of the tested files. See id. at 390 (test results) and 392 (photo).
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`Case PGR2015-00019
`Patent 8,876,991 B2
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`Regarding hearsay, Petitioner argues that Dr. Luebke’s declaration, including
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`Exhibit A, is inadmissible because it was not submitted with testimony in this trial.
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`(Paper 40 at 2.) First, the statements in Dr. Luebke’s declaration were based on his
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`personal knowledge, and sworn to be true with the knowledge that willful false
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`statements would be punishable under the law. See Ex. 2034 at 383 (¶7). Second,
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`Exhibit A was signed by Nick Chadd and Nolan Knight in the ordinary course of
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`business at the time the report was released. See Ex. 2034 at 384–85. Third,
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`Petitioner cross-examined Dr. Luebke about this declaration. See Ex. 1044.
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`Although that deposition was for the related district court litigation, Petitioner
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`never requested Patent Owner to make Dr. Luebke, or any declarants, available for
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`deposition in this trial. Therefore, even assuming arguendo that the statements in
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`Ex. 2034 are hearsay, they are admissible under Fed. R. Evid. 807 because: (1)
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`there are circumstantial guarantees of trustworthiness associated with submitting a
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`declaration with the PTO; (2) the declaration was offered as evidence of a material
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`fact; and (3) the declaration is more probative for showing that “Dr. Luebke
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`submitted information to the Patent Office demonstrating that a heat-treatment at
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`300°C resulted in a file that satisfies the permanent deformation of the ‘wherein’
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`clause,” than any other evidence. Accordingly, the interests of justice and the
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`purposes of the hearsay rule will be best served by denying Petitioner’s motion.
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`III. Exhibit 2035
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`Case PGR2015-00019
`Patent 8,876,991 B2
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`Ex. 2035 is a copy of Kowalski Heat Treating Company Certification, dated
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`January 15, 2016. Petitioner argues that Ex. 2035 contains inadmissible hearsay
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`and lacks authentication. (Paper 40 at 3–4.)
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`Regarding authentication, Ex. 2035 is a signed certification attesting to the
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`heat treatment of certain endodontic files (Part No. PIT042025) in a molten salt
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`bath at 400°C for 10 minutes. The signed certification was printed on an
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`“O.C.T.A.®2000 Certification Form” with the name Kowalski Heat Treating
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`Company and its trade logo on the top of the page. The signed certification
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`contains the address, telephone, and fax number for Kowalski Heat Treating
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`Company on the bottom of the page. Because the signed certification contains
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`inscription affixed during the normal course of business, there is no doubt as to the
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`origin, ownership, and control of the document. And Petitioner has not pointed to
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`any discrepancies or articulated any reason for questioning whether Ex. 2035 is
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`what it purports to be. Thus, Ex. 2035 is a self-authenticating document under Fed.
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`R. Evid. 902(7). See, e.g., Alexander, 576 F.3d at 561; Reitz, 2009 WL 5170200, at
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`*5 n.7. Additionally, Petitioner is in possession of Substitute Ex. 2051 in IPR2015-
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`00632—a declaration from David Lorenz attaching Exhibit A (a certified work
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`order signed by Mr. Lorenz). Said Exhibit A is identical to Ex. 2035. Petitioner
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`possesses documents that belie its assertion that Ex. 2035 contains an illegible
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`Case PGR2015-00019
`Patent 8,876,991 B2
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`signature from an unidentified individual.
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`Regarding hearsay, Petitioner argues that no exceptions to the rule against
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`hearsay are applicable to the statements in Ex. 2035. The certification states: “The
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`above stated parts were annealed by immersing them in a molten salt bath at (400
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`C) 752 F +- 5F for 10 minutes and subsequently water quenched.”1 Petitioner
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`never requested that Patent Owner make the declarant, David Lorenz, available for
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`deposition. And even assuming arguendo that Mr. Lorenz’s statements are hearsay,
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`Ex. 2035 is admissible under Fed. R. Evid. 807 because: (1) there are
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`circumstantial guarantees of trustworthiness associated with submitting documents
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`with the Board under Rule 42.11; (2) the signed certification was offered as
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`evidence of a material fact; and (3) the signed certification is more probative for
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`showing that “Patent Owner replicated the process described in Kuhn and heated
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`the same file specimens as set forth in Kuhn” than any other evidence.
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`Accordingly, the interests of justice and the purposes of the hearsay rule will be
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`best served by denying Petitioner’s motion.
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`IV. Exhibit 2036
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`1 The remaining sentence, “Process instructions were supplied by Jason Nolan,”
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`does not detract from the admissibility of the previous statement.
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`7
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`Ex. 2036 is a copy of KMT ProFile Rotary File ISO 3630-1 Section 7.5
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`Case PGR2015-00019
`Patent 8,876,991 B2
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`Stiffness Testing Final Report, dated January 18, 2016. Petitioner argues that
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`Ex. 2036 contains inadmissible hearsay and lacks authentication. (Paper 40 at 4–5.)
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`Petitioner argues that Ex. 2036 is inadmissible because there is no sworn
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`testimony showing that Ex. 2036 is a true and correct copy of a report prepared by
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`KMT. (Paper 40 at 5.) But, as noted above, testimony is not required. See Fed. R.
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`Evid. 901 (listing testimony as one example). Rule 901 states that distinctive
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`characteristics and the like may satisfy the requirement of authenticating evidence.
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`Ex. 2036 was signed by Nick Chadd and Nolan Knight on January 18, 2016.
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`Ex. 2036 at 1/12. Ex. 2036 bears KMT Report No. TR1114-001 and is titled
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`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report. Id.
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`Ex. 2036 is consecutively paginated from 1/12 to 12/12. Id. Each page is printed on
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`corporate letterhead, which contains on the top of the page, the name Knight
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`Mechanical Testing, the stylized trade logo KMT, and the address, telephone, and
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`fax number. Because Ex. 2036 is signed and contains inscription affixed during the
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`normal course of business, there is no doubt as to the origin, ownership, and
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`control of the document. And Petitioner has not pointed to any discrepancies or
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`articulated any reason for questioning whether Ex. 2036 is what it purports to be.
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`Therefore, Ex. 2036 is self-authenticating under Fed. R. Evid. 902(7). See, e.g.,
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`Alexander, 576 F.3d at 561; Reitz, 2009 WL 5170200, at *5 n.7.
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`Petitioner also argues that the identification, authenticity, and chain of
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`Case PGR2015-00019
`Patent 8,876,991 B2
`
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`custody of the endodontic file samples tested by KMT have not been confirmed.
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`(Paper 40 at 5.) This argument ignores the record. After the heat treatment, the
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`Kowalski Heat Treating Company sent the ProFiles to KMT for testing according
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`to ISO 3630-1. See Ex. 2036 at 4/12 (§3.1). Ex. 2036 includes photos of the file
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`samples after testing and reports the angle of permanent deformation for each of
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`the tested files. See id. at 7/12 (test results) and 9–11 (photos). Additionally,
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`Petitioner is in possession of Substitute Ex. 2052 in IPR2015-00632—a declaration
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`from Nolan Knight and Exhibit A (a testing report for materials provided by
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`Kowalski Heat Treating Company). Said Exhibit A is identical to Ex. 2036.
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`Regarding hearsay, Petitioner argues that no exceptions to the rule against
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`hearsay are applicable to the statements in Ex. 2036. Petitioner never requested
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`that Patent Owner make the declarants, Nick Chadd and Nolan Knight, available
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`for deposition. And even assuming arguendo that their statements are hearsay,
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`Ex. 2036 is admissible under Fed. R. Evid. 807 because: (1) there are
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`circumstantial guarantees of trustworthiness associated with submitting documents
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`with the Board under Rule 42.11; (2) the signed report was offered as evidence of a
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`material fact; and (3) the signed report is more probative for showing that “Patent
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`Owner replicated the process described in Kuhn” and that the files “did not exhibit
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`greater than 10 degrees of permanent deformation as required by the claims of the
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`’991 patent,” than any other evidence. Accordingly, the interests of justice and the
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`Case PGR2015-00019
`Patent 8,876,991 B2
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`purposes of the hearsay rule will be best served by denying Petitioner’s motion.
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`V. Exhibit 2038
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`Ex. 2038 is a copy of email communications between Dr. Neill H. Luebke
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`and Bobby Bennett, dated June 27, 2010 and July 6, 2010. Petitioner incorrectly
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`argues that the email contains hearsay statements from Dr. Luebke and
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`Mr. Bennett. But Mr. Bennett is a real party in interest in this proceeding.
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`Petitioner is owned in part by Mr. Bennett. Therefore, Mr. Bennett’s statements in
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`the email are not hearsay under FRE 801(d)(2) because they are offered against a
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`party opponent. And if they were hearsay, then they should remain in the record
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`because of the circumstantial indicia of trustworthiness. Mr. Bennett’s statements
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`in the email were made by a real party in interest, are contemporaneous with the
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`date of the email, and avoid any of the dangers associated with hearsay, such as
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`perception, memory, narration, and sincerity.
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`Further, Petitioner had an opportunity to cross-examine Dr. Luebke on his
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`statements in Ex. 2038, but declined to do so. A copy of the same document was
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`used as an exhibit during Dr. Luebke’s December 9, 2015 deposition in IPR2015-
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`00632. See IPR2015-00632 Ex. 2044 and Ex. 2046 at 196. Counsel for Petitioner
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`questioned Dr. Luebke for 35 minutes on re-cross, but chose not to ask any
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`questions about Ex. 2044. See IPR2015-00632 Ex. 2046 at 237–262. Therefore,
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`assuming arguendo that his statements are hearsay, Ex. 2038 is admissible under
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`Case PGR2015-00019
`Patent 8,876,991 B2
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`Fed. R. Evid. 807 because: (1) there are circumstantial guarantees of
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`trustworthiness associated with Petitioner’s opportunity to cross-examine Dr.
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`Luebke; (2) the email communications were offered as evidence of a material fact;
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`and (3) the email communications are more probative for showing that “Mr.
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`Bennett engaged in licensing discussions with Luebke and sent Luebke a proposal
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`for licensing his invention,” than any other evidence. The interests of justice and
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`the purposes of the hearsay rule will be best served by denying Petitioner’s motion.
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`VI. Exhibit 2047
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`Exhibit 2047 is the deposition transcript of Dr. A. Jon Goldberg. Petitioner
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`argues that a substantial portion of the transcript should be excluded as falling
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`outside the scope of Dr. Goldberg’s supplemental declaration. Specifically,
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`Petitioner moves to exclude 16:17–19:5; 27:21–31:22; 33:19–41:8; 41:15–59:10;
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`70:3–106:2; and 127:17–186:10. Petitioner does not argue that those portions of
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`the transcript are not relevant to one or more issues in this trial. And Petitioner
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`does not argue that those portions of the transcript are not relevant to
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`Dr. Goldberg’s direct testimony. Petitioner therefore concedes that the testimony in
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`those portions of the transcript is relevant to the issues of this trial.
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`Petitioner has not met its burden of establishing that any of the questions and
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`answers in 16:17–19:5; 27:21–31:22; 33:19–41:8; 41:15–59:10; 70:3–106:2; and
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`127:17–186:10 are beyond the scope of Dr. Goldberg’s direct testimony. Petitioner
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`Case PGR2015-00019
`Patent 8,876,991 B2
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`neither describes the substance of the testimony in 16:17–19:5; 27:21–31:22;
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`33:19–41:8; 41:15–59:10; 70:3–106:2, nor explains why it is beyond the scope of
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`Dr. Goldberg’s direct testimony. Rule 42.64(c) requires a motion to “explain the
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`objections.” Here, Petitioner’s bare assertion that such testimony is beyond the
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`scope of Dr. Goldberg’s direct testimony is a conclusion, not an explanation.
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`Assuming arguendo that Petitioner will explain the basis for its objection in
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`its Reply to this Opposition, and that the Board will consider such an untimely
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`explanation, the exclusion of the testimony would still be an improper remedy.
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`Petitioner does not move to exclude other portions of the transcript, such as: 8:23–
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`9:13, where Dr. Goldberg testified to having been paid over $225,000 by counsel
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`for Petitioner; 12:9–16:16, where Dr. Goldberg testified as to whether the ISO
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`3630-1 bend testing required in the claims of the ’991 patent is “unusual,”
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`“ordinary,” or “routine”; 23:9–27:20, where Dr. Goldberg testified that Petitioner’s
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`supplemental testing supports his opinions in his original declaration (Ex. 1002),
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`and that he is familiar with articles discussing the heat treatment of nickel titanium
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`alloys; or 69:6–70:2, where Dr. Goldberg testified that he was unaware of any heat
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`treatments done by Petitioner at 400°C, 500°C, 600°C, 700°C, or 800°C. As such,
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`questions addressing Dr. Goldberg’s bias and credibility, and questions addressing
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`the basis for his opinion that the claimed invention is allegedly not enabled, are not
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`outside the scope of Dr. Goldberg’s testimony. See, e.g., Apple Inc. v. Smartflash,
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`Case PGR2015-00019
`Patent 8,876,991 B2
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`LLC, Case No. CBM2014-00102, slip op. at 41 (Paper 52 Sept. 25, 2015)
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`(discussing the admissibility of deposition testimony in Ex. 1031). The testimony
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`in 16:17–19:5; 27:21–31:22; 33:19–41:8; 41:15–59:10; 70:3–106:2; and 127:17–
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`186:10 cannot be excluded merely because the questions did not mention the data
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`in Ex. 1041. Id. The interests of justice will be best served by denying Petitioner’s
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`motion.
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`VII. Conclusion
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`Based on the foregoing, the Board should deny Petitioner’s motion to
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`exclude Ex. 2034, Ex. 2035, Ex. 2036, Ex. 2038, and portions of Ex. 2047.
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`Dated: October 3, 2016
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`Respectfully submitted,
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`By: / Jason M. Nolan /
`
`Jason M. Nolan, Reg. No. 72427
`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
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`CERTIFICATE OF SERVICE
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`Case PGR2015-00019
`Patent 8,876,991 B2
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`I hereby certify that on this 3rd day of October 2016, a true and correct copy
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`of the foregoing PATENT OWNER’S OPPOSITION TO PETITIONER’S
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`MOTION TO EXCLUDE was served, via electronic mail upon the following
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`counsel for Petitioner US Endodontics, LLC:
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`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
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`
`
`
`/ Erik van Leeuwen /
`Erik van Leeuwen
`Litigation Operations Coordinator
`Rothwell, Figg, Ernst & Manbeck, P.C.
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`1