`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`v.
`
`GOLD STANDARD INSTRUMENTS, LLC
`Patent Owner.
`
`
`
`
`
`Case IPR2015-00632
`Patent 8,727,773 B2
`
`
`PETITIONER’S OPPOSITION
`TO PATENT OWNER’S MOTION TO EXCLUDE
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`
`
`
`
`
`
`TABLE OF CONTENTS
`TABLE OF CONTENTS
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`PAGE
`1
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`I.
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`EXHIBIT 1005 IS ADMISSIBLE ................................................................... 1
`EXHIBIT 1005 IS ADMISSIBLE ................................................................. ..1
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`II.
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`EXHIBIT 1014 IS ADMISSIBLE ................................................................... 3
`EXHIBIT 1014 IS ADMISSIBLE ................................................................. ..3
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`III. EXHIBIT 1037 IS ADMISSIBLE ................................................................... 5
`III.
`EXHIBIT 1037 IS ADMISSIBLE ................................................................. ..5
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`IV. THE OBJECTED-TO PORTIONS OF EXHIBITS 1038, 2045,
`IV.
`THE OBJECTED—TO PORTIONS OF EXHIBITS 1038, 2045,
`AND 2046 ARE ADMISSIBLE ..................................................................... 7
`AND 2046 ARE ADMISSIBLE ................................................................... ..7
`
`V.
`
`CONCLUSION .............................................................................................. 15
`CONCLUSION ............................................................................................ .. 15
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`
`
`
`
`i
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`
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`Petitioner US Endodontics, LLC opposes Patent Owner’s motion to exclude:
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`Exhibits 1005, 1014, and 1037; a portion of Petitioner’s Reply (Paper 57) that
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`relies on such exhibits; and Exhibits 1038, 2045 and 2046 at 154:12-155:2, 157:20-
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`158:15, 161:21-163:5, 66:18-67:14, and 68:3-17. Paper 63. For the reasons
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`discussed herein, Patent Owner’s motion should be denied in its entirety.
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`I.
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`EXHIBIT 1005 IS ADMISSIBLE
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`Exhibit 1005 is a Ph.D. thesis from 2006 authored by Satish B. Alapati and
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`entitled, “An investigation of phase transformation mechanisms for nickel-titanium
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`rotary endodontic instruments” (“Alapati”).
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`As an initial matter, Alapati was introduced during the cross-examination of
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`Patent Owner’s expert, Dr. Sinclair, and Patent Owner did not move to exclude
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`such testimony. See Ex. 1040, 134:19-140:7. Patent Owner argues that since
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`Alapati “is not prior art, it is not relevant to any ground upon which trial has been
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`instituted.” See Paper 63, p. 3. Patent Owner is wrong. Petitioner relies on Alapati
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`as additional evidence that: (i) a skilled artisan would look beyond the endodontic
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`field for useful nickel titanium (“Ni-Ti”) art; (ii) Ni-Ti will be superelastic when in
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`the austenite phase, i.e., when the Ni-Ti alloy is in an environment where the
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`ambient temperature is above the alloy’s austenite finish (Af) (i.e., shape recovery)
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`temperature; and (iii) equates raising the Af (shape recovery) temperature of a Ni-
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`Ti alloy to above body temperature with decreasing superelasticity such that the
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`1
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`
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`Ni-Ti alloy will exhibit permanent deformation when bent. See Paper 2, pp. 3-4,
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`46; Paper 57, p. 10. See also Ex. 1002, ¶ 66. Such information further rebuts the
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`arguments from Patent Owner and its expert, Dr. Sinclair, that the combination of
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`Matsutani and Pelton would not result in “permanent deformation as required.”
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`Paper 44, p. 52-54. See also Ex. 2026, ¶¶ 49-50, 179. For example, in the portion
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`cited by Petitioner in its Reply brief, see Paper 57, p. 10, Alapati states:
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`“Heat treatment of NiTi rotary instruments between 400° and 600°C
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`increases the austenite-finish (Af) transformation temperature from
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`approximately 25°C for as-received instruments to 50°C, which
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`results in the loss of shape memory in the oral environment
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`(Brantley, 2001).”
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`Ex. 1005, p. 59-60 of 76 (emphasis added). This contradicts Patent Owner’s and
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`Dr. Sinclair’s assertions that the combination of Matsutani and Pelton does not
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`“teach or suggest a heat-treated NiTi file that would exhibit at least 10 degrees of
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`permanent deformation in the ISO Standard 3630-1 bend test.” Paper 44, pp. 52-
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`53. See also Ex. 2026, ¶¶ 49-50, 179. Indeed, the quoted passage evidences the
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`knowledge of a skilled artisan at least as of the earliest effective filing date of the
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`’773 patent, as it cites to a published article from 2001. Ex. 1005, pp. 59-60, 70 of
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`76 (citing “Brantley WA (2001). Orthodontic wires. In: Brantley WA, Eliades T,
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`editors. Orthodontic Materials: Scientific and Clinical Aspects. Stuttgart: Thieme,
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`pp. 77-103.”) Thus, Alapati is relevant, under FRE 401, because it has a tendency
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`2
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`
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`to make it more probable that, on this issue, Patent Owner and its expert are
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`incorrect, and Petitioner’s position is the correct one.
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`Patent Owner also argues that Alapati is hearsay. See Paper 63, p. 3.
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`However, even if the Board determines it is hearsay, which Petitioner disputes,
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`Alapati is still admissible under FRE 703. Petitioner’s expert, Dr. Goldberg,
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`reasonably relied on Alapati in further support of his opinion that one of skill in the
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`art would have looked to Ni-Ti art beyond the endodontic field when trying to
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`solve problems within the endodontic field. See Ex. 1002, ¶ 66; Paper 2, p. 46.
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`Thus, Alapati is admissible under FRE 703 as it served as a basis for Petitioner’s
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`expert’s opinions.
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`
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`Accordingly, Exhibit 1005 is admissible and should not be excluded.
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`II. EXHIBIT 1014 IS ADMISSIBLE
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`Exhibit 1014 is U.S. Patent Application Publication No. 2011/0271529 A1,
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`Gao et al. (“Gao”), which is assigned to Dentsply International Inc. (“Dentsply”), a
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`real party-in-interest in this proceeding.
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`Again, as an initial matter, Gao was introduced during the cross-examination
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`of Patent Owner’s expert and Patent Owner did not move to exclude such
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`testimony. See Ex. 1040, 140:8-144:1. Patent Owner argues, as it did for Exhibit
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`1005, that Gao is not relevant because it is not prior art to the ’773 patent. See
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`Paper 63, p. 4. In view of the Board’s decision regarding the effective filing date of
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`3
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`
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`the ’773 patent, Petitioner does not rely upon Gao as a prior art reference that
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`renders the claims of the ’773 patent unpatentable. Instead, Petitioner relies on Gao
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`as further evidence that equates raising the Af (shape recovery) temperature of a
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`Ni-Ti alloy to above body temperature with decreasing superelasticity such that the
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`Ni-Ti alloy will exhibit permanent deformation when bent. See Paper 57, p. 10; Ex.
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`1002, ¶ 112. Again, this rebuts Patent Owner’s and its expert’s arguments that the
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`combination of the Matsutani and Pelton prior art references would not meet the
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`claimed permanent deformation limitation. See Paper 44, pp. 52-54; Ex. 2026, ¶¶
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`49-50, 179. Specifically, in the portions cited by Petitioner in its Reply brief, see
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`Paper 57, p. 10, Gao states:
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`“Due to higher austenite finish temperature, the present invention
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`instrument would not return to the original complete straight state
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`after being bent or deflected; in contrast, most standard superelastic
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`NiTi rotary instruments can return to the original straight form via
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`reverse
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`phase
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`transformation
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`(martensite-to-austenite)
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`upon
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`unloading.”
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`Ex. 1014, ¶ 25 (emphasis added).
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`“A method for manufacturing a non-superelastic rotary file
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`comprising . . . heating the superelastic rotary file to a temperature of
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`at least about 300° C. for a time period of at least about 5 minutes to
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`alter the austenite finish temperature thereby forming the non-
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`superelastic rotary file; wherein
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`the altered austenite finish
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`4
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`
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`temperature of the non-superelastic rotary file is greater than about
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`25° C.”
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`Ex. 1014, ¶ 62 (emphasis added). These quoted portions of Gao directly contradict
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`Patent Owner’s and Dr. Sinclair’s assertions that the combination of Matsutani and
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`Pelton would not result in a Ni-Ti shank that would meet the permanent
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`deformation limitation of the claims of the ’773 patent. Moreover, the statements
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`in Gao, which has been assigned to real party-in-interest Dentsply and were made
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`by Dentsply representatives, are party admissions. FRE 801(d)(2). Thus, Gao is
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`relevant, under FRE 401, because it has a tendency to make it more probable that,
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`on this issue, Patent Owner and its expert are incorrect, and Petitioner’s position is
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`the correct one.
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`
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`Accordingly, Exhibit 1014 is admissible and should not be excluded.
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`III. EXHIBIT 1037 IS ADMISSIBLE
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`Exhibit 1037 is U.S. Patent No. 6,149,501 to Farzin-Nia (“Farzin-Nia”).
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`Petitioner relies on Farzin-Nia as further rebuttal to Patent Owner’s and its
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`expert’s arguments that the combination of the Matsutani and Pelton prior art
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`references would not meet the claimed permanent deformation limitation. Paper
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`44, pp. 52-54. See also Ex. 2026, ¶¶ 49-50, 179. In the portion cited in Petitioner’s
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`Reply brief, see Paper 57, p. 10, Farzin-Nia states:
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`“Superelastic alloys are in the martensitic phase when they are below
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`the austenitic transformation temperature Af, i.e., the temperature at
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`5
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`
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`which the material is about 100% austenite. These alloys retain their
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`deformed shape when subjected to stress in the martensitic phase.”
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`Ex. 1037, 4:12-16.
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`Once again, Exhibit 1037 was introduced during the cross-examination of
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`Patent Owner’s expert, Dr. Sinclair, and Patent Owner did not move to exclude
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`such testimony. See Ex. 1040, 133:2-134:18. Patent Owner does not argue that
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`Farzin-Nia is irrelevant. Rather, it argues that Farzin-Nia is hearsay not subject to
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`any exception. See Paper 63, p. 4. This is incorrect. A patent issued by the U.S.
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`Patent & Trademark Office (“USPTO”) falls under the hearsay exception for
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`public records. Under FRE 803(8)(A), Farzin-Nia is a “public record,” i.e., an
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`issued patent, reflecting an “activit[y]” of the USPTO, i.e., issuing patents. Under
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`FRE 803(8)(B), neither the source of Farzin-Nia, i.e., the USPTO, nor other
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`circumstances, indicate a lack of trustworthiness.
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`Indeed, Patent Owner has failed to carry its burden of “show[ing] that the
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`source of information or other circumstances indicate a lack of trustworthiness.”
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`See Fresenius Med. Care Holdings, Inc. v. Baxter Int’l, Inc., No. 03-1431, 2006
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`WL 1330003, at *2-3 (N.D. Cal. May 15, 2006) (“With respect to public records,
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`the presumption is one of trustworthiness, and the burden of establishing
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`untrustworthiness falls on the opponent of the evidence. A party opposing the
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`introduction of a public record bears the burden of coming forward with enough
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`negative factors to persuade a court that a report should not be
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`6
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`admitted. The [USPTO] is an agency of the United States, within the Department
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`of Commerce, and thus falls squarely within the ‘public offices or agencies’
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`requirement of Rule 803(8).”) (internal citations omitted).
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`
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`Accordingly, Exhibit 1037 is admissible and should not be excluded.
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`IV. THE OBJECTED-TO PORTIONS OF EXHIBITS 1038, 2045, AND
`2046 ARE ADMISSIBLE
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`Exhibit 1038 is Deposition Transcript of Neill H. Luebke, D.D.S., M.S.,
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`dated December 9, 2015 (Public/Redacted Version). Exhibit 2045 is identical to
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`Exhibit 1038 but for its inclusion of a cover page. Exhibit 2046 is identical to
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`Exhibits 1038 and 2045 but for its lack of redactions. Patent Owner moves to strike
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`the following portions of the transcript of Dr. Luebke’s cross-examination: 154:12-
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`155:2, 157:20-158:15, 161:21-163:5, 66:18-67:14, and 68:3-17. Contrary to Patent
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`Owner’s objections, this testimony is within the scope of Dr. Luebke’s direct
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`testimony in this proceeding.
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`A. Background
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`Dr. Luebke is the named inventor on the ’773 patent, of which real party-in-
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`interest Dentsply is the exclusive licensee. In this proceeding, Dr. Luebke
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`submitted a 29-page declaration concurrently with Patent Owner’s Response. See
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`Ex. 2027. The declaration contains the following topical headings: “Background of
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`the ’773 Patent”; “The Invention of the ’773 Patent”; “The Claims of the ’773
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`7
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`Patent”; “The Invention of the ’773 Patent Initially Met with Skepticism”; “Efforts
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`to Commercialize the Invention of the ’773 Patent”; “The Invention of the ’773
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`Patent is Commercially Successful”; and “Prosecution History of the ’991 Patent.”
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`As previously explained to the Board, see Ex. 1038, 34:21-36:22, in the
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`related district court proceeding, Dr. Luebke served as a technical expert for
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`Plaintiff Dentsply, and testified at length on validity issues. Patent Owner has
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`relied on Dr. Luebke’s testimony from the district court case to support its
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`arguments in this proceeding relating to several prior art references at issue,
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`including the Kuhn and McSpadden references (Exs. 1019 and 1022). See, e.g.,
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`Paper 9, pp. 30-31 (citing Ex. 2001, pp. 65-66 regarding the Kuhn reference);
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`Paper 44, p. 40 (citing Ex. 2001, pp. 163-165 regarding the McSpadden reference).
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`It would be unfair to allow Patent Owner to rely on Dr. Luebke’s district court
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`testimony regarding the prior art at issue in this proceeding, and at the same time to
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`foreclose Petitioner’s reliance on Dr. Luebke’s admissions in this proceeding
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`regarding the same.
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`B.
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`The Objected-To Cross-Examination Testimony Should Not Be
`Stricken
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`Patent Owner moves to strike Exhibit 1038, 154:12-155:2, in which Dr.
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`Luebke testified regarding the meaning of “shape memory” as recited in Matsutani:
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`Q Now, in Column 4, going back to Matsutani, that's Exhibit 1023,
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`Matsutani says that subjecting a portion of this superelastic
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`8
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`endodontic file to heat treatment results in a shape memory portion to
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`allow the dentist to be able to precurve the file. Correct?
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`A That's what it says.
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`MR. DAHLGREN: Objection. Scope.
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`Q That means when the dentist bends the file, it will stay in its bent
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`curved shape after the bending force is removed. Correct?
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`MR. DAHLGREN: Objection. Scope.
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`A I presume that's what they're saying.
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`This cross-examination testimony is squarely within the scope of Dr. Luebke’s
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`direct testimony regarding the meaning of “shape memory”:
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`“The post heat-treating process changes the shape memory
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`characteristic of the NiTi file so that the file bends easily and can
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`retain its bent shape, even at body temperature. This is an important
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`and useful characteristic for practitioners because it allows the file
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`to follow the natural curvature of the root and not create a ledge.”
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`Ex. 2027, ¶ 32 (emphasis added). Further, the referenced portion of Matsutani
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`discusses what the “shape memory” trait “allow[s] the dentist to be able to” do,
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`which is also within the scope of the testimony from Dr. Luebke (who himself was
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`an endodontist) regarding shape memory being “an important and useful
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`characteristic for practitioners.” Id. The cross-examination testimony regarding
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`Matsutani, Ex. 1023, also shows that Dr. Luebke was not the first to recognize the
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`effects of heat-treating nickel-titanium files, and undermines his statements that the
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`’773 patent met with skepticism.
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`9
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`Patent Owner also moves to strike Exhibit 1038, 157:20-158:15, in which
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`Dr. Luebke testified regarding file characteristics that resulted from Matsutani’s
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`disclosed heat-treatment:
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`Q Going back to the Matsutani reference, which is Exhibit 1023.
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`Matsutani states that the precurving of the shape memory portion
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`enables the tip of the shape memory portion to follow the root canal
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`with high fidelity at the time of inserting the tip into the root canal and
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`performing treatment of the root canal. Do you see that?
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`A I do.
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`MR. DAHLGREN: Objection. Scope.
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`Q Matsutani, at Lines 58 to 62, specifically discloses that the heat-
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`treated portion retains its shape when bent and has a high flexibility.
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`Correct?
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`MR. DAHLGREN: Objection. Scope.
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`A At 58?
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`Q Yes. Column 4, Lines 58 to 62.
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`A It says, high flexibility and high fatigue resistance characteristic.
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`This cross-examination testimony is squarely within the scope of Dr. Luebke’s
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`direct testimony in Exhibit 2027, ¶ 32 (“shape memory”), discussed above, as well
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`as his direct testimony in Exhibit 2027, ¶¶ 12 (challenges faced by endodontists of
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`navigating root canals), 17 (desirability of nickel-titanium due to its flexibility and
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`strength), 19 (tendency of superelastic nickel-titanium files to fracture during use),
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`22 (same), 29 (results of Dr. Luebke’s alleged laboratory testing showing that heat
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`10
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`
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`treatment made files more flexible and more resilient), 30 (Dr. Luebke’s “eureka
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`moment”), 37 (alleged skepticism that the ’773 patent met with for resulting in
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`files that were softer and flexible), and 39 (same). The cross-examination
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`testimony regarding Matsutani also shows that Dr. Luebke was not the first to
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`recognize the effects of heat-treating nickel-titanium files, and undermines his
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`statements that the ’773 patent met with skepticism.
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`Patent Owner also moves to strike Exhibit 1038, 161:21-163:5, in which Dr.
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`Luebke testified that the bending test described in Matsutani is substantially similar
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`to the test described in ISO Standard 3630-1. This cross-examination testimony is
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`squarely within the scope of Dr. Luebke’s direct testimony regarding his alleged
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`experience in conducting bend tests on files, including bend tests he allegedly
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`performed in accordance with ISO Standard 3630-1. Ex. 2027, ¶¶ 27, 28, 32, 50,
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`51, 54, 55. The cross-examination testimony also shows that Dr. Luebke was not
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`the first to perform the claimed bend testing to measure permanent deformation of
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`heat-treated nickel-titanium files.
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`Patent Owner also moves to strike Exhibit 1038, 66:18-67:14, in which Dr.
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`Luebke testified regarding the state of the prior art and the endodontic file market,
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`as well as ISO Standard 3630-1:
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`Q The ProFile files that are disclosed in Kuhn were available in sizes
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`that were described in ISO Standard 3630-1. Correct?
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`MR. DAHLGREN: Objection. Scope.
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`11
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`
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`A In the -- in the current -- let me -- let me step back one. The 1992
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`ISO standard did not have taper. So the answer is, yes, they were to
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`the current ISO standard that was -- that was being -- everybody saw.
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`So the answer to that is yes.
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`Q The current standard that everybody saw at the time that you filed
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`your 2004 application was the ISO standard that was in effect in 1992.
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`Correct? That was the first edition?
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`MR. DAHLGREN: Objection. Form.
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`A No. We already went through that. The two thousand -- in 2001, the
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`standards changed. So Kuhn's files would have fallen under that ISO
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`standard.
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`Patent Owner moves to strike this entire testimony based on separate objections to
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`scope and form. However, during the cross-examination, Patent Owner did not
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`object to the first question based on form, or to the second question based on
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`scope. Thus, Patent Owner waived any objection to the first question as to form,
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`and any objection to the second question as to scope. See 37 C.F.R. § 42.53(f)(8)
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`(“Any objection to the content, form, or manner of taking the deposition . . . is
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`waived unless made on the record during the deposition . . . .”).
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`The first cross-examination question above is squarely within the scope of
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`Dr. Luebke’s direct testimony regarding the state of the prior art and the
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`endodontic file market, see Ex. 2027, ¶¶ 17-20, including testimony regarding the
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`sizes of files the industry offered:
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`12
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`
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`“The industry recognized the problem and attempted to address the
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`fracture of superelastic NiTi files. The problem was attributed to a
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`lack of strength in the files. Some manufacturers increased the
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`diameter of the core of the files, but this failed to solve the problem.
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`Others tried to solve the fracture problem by increasing the taper of
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`the file from the standard 2 percent taper up to 4 percent, then 6
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`percent, then 8 percent and even up to 10 percent taper, resulting in
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`thicker files, but this also failed to solve the fracture problem. The
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`larger files and increased taper created stiffer files and created an
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`additional problem because the files removed more tooth structure,
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`which then could compromise the tooth.”
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`Ex. 2027, ¶ 22. Dr. Luebke’s cross-examination testimony also shows that he was
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`not the first to provide nickel-titanium endodontic files in sizes in accordance with
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`ISO Standard 3630-1.
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`With respect to the second cross-examination question above, Patent Owner
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`chose to object not to the scope of the question, but rather, to the form. However,
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`Patent Owner’s motion fails to provide any explanation for its objection to the
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`form of the question, and therefore, its motion to strike the second question and
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`responsive testimony should be denied. Further, regarding scope, the question is
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`squarely within the scope of Dr. Luebke’s direct testimony regarding his alleged
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`experience in conducting bend tests on files, including bend tests he allegedly
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`performed in accordance with ISO Standard 3630-1. Ex. 2027, ¶¶ 27, 28, 32, 50,
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`51, 54, 55.
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`13
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`
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`Patent Owner also moves to strike Exhibit 1038, 68:3-17, in which Dr.
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`Luebke testified regarding the state of the prior art and the endodontic file market:
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`Q I'll ask the question again. The ProFile files that are disclosed in
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`Kuhn, which is Exhibit 1019 in this proceeding, were available in
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`sizes disclosed in ISO Standard 3630-1. Correct?
`
`A Yes.
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`Q The ProFile files were at the time being sold by, is it Maillefer?
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`A Maillefer in Switzerland? Yes.
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`Q Dentsply, your licensee, eventually acquired Maillefer. Is that
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`correct?
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`A I don't know the details, but that's correct.
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`Q The Kuhn reference that we've been discussing, I'm handing you a
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`copy of. That's Exhibit 1019.
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`Patent Owner failed to raise any objections to this questioning by Petitioner,
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`thereby waiving any objection that it now belatedly attempts to lodge. See 37
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`C.F.R. § 42.53(f)(8). For this reason, Patent Owner’s motion to strike these
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`questions and responsive testimony should be denied. Further, the questioning
`
`above is squarely within the scope of Dr. Luebke’s direct testimony regarding the
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`state of the prior art and the endodontic file market, see Ex. 2027, ¶¶ 17-20,
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`including testimony regarding the sizes of files the industry offered, see id. at ¶ 22,
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`as well as his direct testimony regarding Maillefer, see id. at fn. 2 (“Maillefer
`
`Instruments Holding Sarl (‘Maillefer’) was a wholly owned Dentsply International
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`14
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`
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`
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`Inc. entity at this time.”). Such cross-examination testimony from Dr. Luebke
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`further shows that he was not the first to provide nickel-titanium endodontic files
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`in sizes in accordance with ISO Standard 3630-1.
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`
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`Accordingly, the objected-to portions of Exhibits 1038, 2045, and 2046 are
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`admissible and should not be excluded.
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`V. CONCLUSION
`
`For the foregoing reasons, Exhibits 1005, 1014, and 1037, the portion of
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`Petitioner Reply (Paper 57) that relies on such exhibits, and Exhibits 1038, 2045
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`and 2046 at 154:12-155:2, 157:20-158:15, 161:21-163:5, 66:18-67:14, and 68:3-
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`17, are admissible, and should not be excluded.
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`Respectfully submitted,
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`Dated: March 16, 2016
`
`/Jeffrey S. Ginsberg/
`Jeffrey S. Ginsberg (Reg. No. 36,148)
`Lead counsel for Petitioner US Endodontics, LLC
`
`Abhishek Bapna (Reg. No. 64,049)
`Back-up counsel for Petitioner US Endodontics, LLC
`
`Patterson Belknap Webb & Tyler LLP
`1133 Avenue of the Americas
`New York, NY 10036-6710
`Tel.: (212) 336-2000
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`15
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on March 16,
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`2016, the foregoing PETITIONER’S OPPOSITION TO PATENT OWNER’S
`
`MOTION TO EXCLUDE was served via electronic mail on the following
`
`counsel of record for the Patent Owner:
`
`Joseph A. Hynds
`(jhynds@rothwellfigg.com)
`R. Elizabeth Brenner-Leifer
`(ebrenner@rothwellfigg.com)
`Steven Lieberman
`(slieberman@rothwellfigg.com)
`Jason M. Nolan
`(jnolan@rothwellfigg.com)
`Derek F. Dahlgren
`(ddahlgren@rothwellfigg.com)
`C. Nichole Gifford
`(ngifford@rothwellfigg.com)
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th Street, N.W., Ste. 800
`Washington, DC 20005
`
`/Abhishek Bapna/
`Abhishek Bapna (Reg. No. 64,049)