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
`
`
`PETITIONER’S OPPOSITION
`TO PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
`
`
`
`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
`
`
`PETITIONER’S OPPOSITION
`TO PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`TABLE OF CONTENTS
`
`PAGE
`1
`
`I.
`I.
`
`EXHIBIT 1005 IS ADMISSIBLE ................................................................... 1
`EXHIBIT 1005 IS ADMISSIBLE ................................................................. ..1
`
`II.
`II.
`
`EXHIBIT 1006 IS ADMISSIBLE ................................................................... 3
`EXHIBIT 1006 IS ADMISSIBLE ................................................................. ..3
`
`III. EXHIBITS 1016 AND 1017 ARE ADMISSIBLE ......................................... 4
`III.
`EXHIBITS 1016 AND 1017 ARE ADMISSIBLE ....................................... ..4
`
`IV. EXHIBITS 1020 AND 1021 ARE ADMISSIBLE ......................................... 5
`IV.
`EXHIBITS 1020 AND 1021 ARE ADMISSIBLE ....................................... ..5
`
`V.
`V.
`
`EXHIBIT 1025 IS ADMISSIBLE ................................................................... 6
`EXHIBIT 1025 IS ADMISSIBLE ................................................................. ..6
`
`VI. EXHIBITS 1034 AND 1038 ARE ADMISSIBLE ......................................... 7
`VI.
`EXHIBITS 1034 AND 1038 ARE ADMISSIBLE ....................................... ..7
`
`VII. EXHIBIT 1036 IS ADMISSIBLE ................................................................... 9
`VII. EXHIBIT 1036 IS ADMISSIBLE ................................................................. ..9
`
`VIII. CONCLUSION .............................................................................................. 10
`VIII. CONCLUSION ............................................................................................ .. 10
`
`
`
`
`
`i
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`
`
`
`
`Petitioner US Endodontics, LLC opposes Patent Owner’s motion to exclude
`
`Exhibits 1005, 1006, 1016, 1017, 1020, 1021, 1025, 1034, 1036, and 1038. For the
`
`reasons discussed herein, Patent Owner’s motion should be denied in its entirety.
`
`I.
`
`EXHIBIT 1005 IS ADMISSIBLE
`
`Exhibit 1005 is a Ph.D. thesis completed in 2006, authored by Satish B.
`
`Alapati, and entitled, “An investigation of phase transformation mechanisms for
`
`nickel-titanium rotary endodontic instruments” (“Alapati”). Patent Owner argues
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`that Alapati is irrelevant to the proceeding because it is “not part of any instituted
`
`ground.” Paper 36, p. 2. Patent Owner also argues that Alapati is “not prior art to
`
`[the ’991 patent].” Id. Patent Owner is wrong on both counts.
`
`As an initial matter, Patent Owner provides no explanation for its assertion
`
`that Alapati is “not prior art” to the ’991 patent. To the contrary, Alapati is prior art
`
`to the ’991 patent since it is a thesis that was catalogued in an Ohio State
`
`University library on June 22, 2006, see Ex. 1005, p. 77—well before the January
`
`29, 2014 effective filing date of the claims 12-16 of the ’991 patent. See Paper 17,
`
`p. 21.
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`Alapati is relevant to several instituted grounds in this proceeding as
`
`exemplary prior art indicating that a person having ordinary skill in the art as of the
`
`January 29, 2014 effective filing date would know that martensite occurs at lower
`
`temperatures and austenite occurs at higher temperatures. See Paper 1, pp. 5-6. It
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`1
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`also serves as evidence that: (i) a skilled artisan would look beyond the endodontic
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`field for useful nickel titanium (“Ni-Ti”) art; and (ii) a skilled artisan would
`
`understand that raising the austenite finish (Af or shape recovery) temperature of a
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`Ni-Ti alloy to above body temperature equates to decreasing its superelasticity
`
`such it will exhibit permanent deformation when bent. See Ex. 1002, ¶ 79; Paper
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`31, p. 10.
`
`Patent Owner also argues that Alapati is hearsay. See Paper 36, p. 2.
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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. A. Jon Goldberg,
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`reasonably relied on Alapati in further support of his opinion that one of ordinary
`
`skill in the art would have looked to Ni-Ti art beyond the endodontic field when
`
`trying to solve problems within the endodontic field. See Ex. 1002, ¶ 79. Thus,
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`Alapati is admissible under FRE 703 as it served as a basis for Petitioner’s expert’s
`
`opinions.
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`Patent Owner also argues that Alapati should be excluded for lack of
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`authentication because Petitioner has not presented any evidence of public
`
`availability, such as “evidence of cataloguing or other indexing.” Patent Owner is
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`wrong. The last two pages of Exhibit 1005 is a library record that shows Alapati
`
`was catalogued in an Ohio State University library on June 22, 2006.
`
`
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`Accordingly, Exhibit 1005 is admissible and should not be excluded.
`
`2
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`
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`
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`II. EXHIBIT 1006 IS ADMISSIBLE
`
`Exhibit 1006 is an article published in 2000, authored by Alan R. Pelton et
`
`al., and entitled, “Optimisation of Processing and Properties of Medical-Grade
`
`Nitinol Wire” (“Pelton”). Patent Owner’s statement that “Petitioner relied on Ex.
`
`1006 on pages 6, 10, 42, 65, 68, and 71 of its Petition (Paper 1) and on page 10 of
`
`its Reply (Paper 31)” omits a number of pages in Petitioner’s papers that contain a
`
`discussion of Pelton, including pages 43-45, 66-67, 69-70, 72, 78, and 79 of the
`
`Petition and pages 11, 13, and 14 of the Reply.
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`Patent Owner argues that Pelton is irrelevant to the instituted grounds
`
`because “no ground relies upon” it. Paper 36, p. 3. Patent Owner is wrong. Pelton
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`is relevant to at least the ground of lack of enablement of claims 12-16 of the ’991
`
`patent, on which the Board instituted this proceeding. See, e.g., Paper 1, pp. 42-45;
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`Ex. 1002, ¶¶ 102, 113-121, 125, and 130; Paper 31, pp. 13-14.
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`Pelton discloses that the transformation temperature of a NiTi alloy did not
`
`change significantly with a treatment temperature of 300°C, and reached only 25°C
`
`after three hours of heat-treatment. See, e.g., Paper 1, pp. 42-43; Ex. 1002, ¶ 102.
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`Additionally, Dr. Goldberg’s testimony on the issue of undue experimentation
`
`includes extensive discussion of Pelton. See Ex. 1002, ¶¶ 114-121, 125; see also
`
`Paper 31, p. 13-14. Since Dr. Goldberg reasonably relied upon Pelton in forming
`
`his opinions, Pelton is additionally admissible under FRE 703.
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`3
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`
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`Accordingly, Exhibit 1006 is admissible and should not be excluded.
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`III. EXHIBITS 1016 AND 1017 ARE ADMISSIBLE
`
`Exhibit 1016 is an article published in 2003, authored by Edgar Schӓfer et
`
`al., and entitled, “Bending Properties of Rotary Nickel-Titanium Instruments”
`
`(“Schӓfer”). Exhibit 1017 is an article published in 2011, authored by Luca
`
`Testarelli et al., and entitled, “Bending Properties of a New Nickel-Titanium Alloy
`
`with a Lower Percent by Weight of Nickel” (“Testarelli”).
`
`Patent Owner argues that Schӓfer and Testarelli are irrelevant to the
`
`instituted grounds because they are “not part of any instituted ground.” Paper 36,
`
`pp. 3-4. Patent Owner also argues that Testarelli is “not prior art to the ’991
`
`patent.” Id. at 4. Patent Owner is wrong on both counts.
`
`As an initial matter, Patent Owner provides no explanation for its assertion
`
`that Testarelli is “not prior art” to the ’991 patent. To the contrary, Testarelli is
`
`prior art to the ’991 patent since it is an article that was published in the Journal of
`
`Endodontics in 2011—well before the January 29, 2014 effective filing date of the
`
`claims 12-16 of the ’991 patent. See Paper 17, p. 21.
`
`Schӓfer and Testarelli are relevant to the ground of lack of enablement of
`
`claims 12-16 of the ’991 patent, on which the Board instituted this proceeding. See
`
`Paper 1, p. 36. Schӓfer and Testarelli each discloses that the ProFile brand Ni-Ti
`
`endodontic files, on which Petitioner commissioned testing to support its position
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`4
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`
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`that the claims at issue in this proceeding are not enabled, have a composition that
`
`is within the scope of the composition range recited in claim 16 of the ’991 patent.
`
`Id. Further, Dr. Goldberg’s testimony on the issue of undue experimentation
`
`includes discussion of Schӓfer and Testarelli. See Ex. 1002, ¶ 104. Since Dr.
`
`Goldberg reasonably relied upon Schӓfer and Testarelli in forming his opinions,
`
`Schӓfer and Testarelli are additionally admissible under FRE 703.
`
`
`
`Accordingly, Exhibits 1016 and 1017 are admissible and should not be
`
`excluded.
`
`IV. EXHIBITS 1020 AND 1021 ARE ADMISSIBLE
`
`Exhibit 1020 is an article published in 2003, authored by Alan R. Pelton et
`
`al., and entitled, “The Physical Metallurgy of Nitinol for Medical Applications”
`
`(“Pelton II”). Exhibit 1021 is an article published in 1982, authored by S. Miyazaki
`
`et al., and entitled, “Characteristics of Deformation and Transformation
`
`Pseudoelasticity in Ti-Ti Alloys” (“Miyazaki”).
`
`Patent Owner argues that Pelton II and Miyazaki are irrelevant to the
`
`instituted grounds because they are “not part of any instituted ground.” Paper 36,
`
`pp. 4-5. Patent Owner is wrong.
`
`Pelton II and Miyazaki are relevant to the ground of lack of enablement of
`
`claims 12-16 of the ’991 patent, on which the Board instituted this proceeding. See
`
`Paper 1, p. 44. Pelton II and Miyazaki each support the fact that the Af (shape
`
`5
`
`
`
`
`
`recovery) temperature of an alloy may vary by 100°C due to even a 1% change in
`
`nickel content within the composition range recited in claim 16 of the ’991 patent.
`
`Id. Further, Dr. Goldberg’s testimony on the issue of undue experimentation
`
`includes discussion of Pelton II and Mizayaki. See Ex. 1002, ¶¶ 113, 120, 122; see
`
`also Paper 31, p. 13-14. Since Dr. Goldberg reasonably relied upon Pelton II and
`
`Mizayaki in forming his opinions, Pelton II and Mizayaki are additionally
`
`admissible under FRE 703.
`
`
`
`Accordingly, Exhibits 1020 and 1021 are admissible and should not be
`
`excluded.
`
`V. EXHIBIT 1025 IS ADMISSIBLE
`
`Exhibit 1025 is U.S. Patent Application Publication No. 2006/0115786 A1
`
`to Matsutani (“Matsutani”), which published on June 1, 2006.
`
`Patent Owner argues that Matsutani is irrelevant to the proceeding because it
`
`is not “part of any instituted ground.” Paper 36, p. 5. Patent Owner also argues that
`
`Matsutani is “not prior art to the ’991 patent.” Id. Patent Owner is wrong on both
`
`counts.
`
`As an initial matter, Patent Owner provides no explanation for its assertion
`
`that Matsutani is “not prior art” to the ’991 patent. To the contrary, Matsutani is
`
`prior art to the ’991 patent since it was published in 2006—well before the January
`
`6
`
`
`
`
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`29, 2014 effective filing date of the claims 12-16 of the ’991 patent. See Paper 17,
`
`p. 21.
`
`Matsutani is relevant to the ground of lack of written description of claims
`
`12-16 of the ’991 patent, on which the Board instituted this proceeding. Matsutani
`
`is exemplary prior art that discloses the “permanent deformability embodied in the
`
`‘wherein’ clause” of the claims of the ’991 patent. Ex. 1002, ¶ 127. Specifically,
`
`Dr. Goldberg noted that Matsutani “disclosed Ni-Ti files that could be pre-curved
`
`by an endodontist and that the heat-treated portion of such file (the needle or
`
`shank), after a bending stress is applied and then removed, ‘keeps a bent shape.’”
`
`Id. Since Dr. Goldberg relied upon such disclosure in Matsutani in forming his
`
`opinions on the lack of written description of claims 12-16 of the ’991 patent, see
`
`id., Matsutani is additionally admissible under FRE 703.
`
`Accordingly, Exhibit 1025 is admissible and should not be excluded.
`
`VI. EXHIBITS 1034 AND 1038 ARE ADMISSIBLE
`
`Exhibit 1034 is an article published in 2006, authored by M. G. A. Bahia,
`
`and entitled, “Fatigue Behaviour of Nickel–Titanium Superelastic Wires and
`
`Endodontic Instruments” (“Bahia”). Exhibit 1038 is an article published in 2002,
`
`authored by W.A. Brantley et al., and entitled, “Differential Scanning Calorimetric
`
`Studies of Nickel Titanium Rotary Endodontic Instruments” (“Brantley”).
`
`7
`
`
`
`
`
`Patent Owner argues that Bahia and Brantley are irrelevant to the instituted
`
`grounds because they are “not part of any instituted ground.” Paper 36, pp. 5-6.
`
`Patent Owner also argues that Bahia is “not prior art to the ’991 patent.” Id. at 5.
`
`Patent Owner is wrong on both counts.
`
`As an initial matter, Patent Owner provides no explanation for its assertion
`
`that Bahia is “not prior art” to the ’991 patent. To the contrary, Bahia is prior art to
`
`the ’991 patent since it is an article that was published by Blackwell Publishing
`
`Ltd. in 2006—well before the January 29, 2014 effective filing date of the claims
`
`12-16 of the ’991 patent. See Paper 17, p. 21.
`
`Bahia and Brantley are relevant to the grounds of anticipation by Kuhn of
`
`claims 12-14 and 16 of the ’991 patent, and obviousness of claim 15 of the ’991
`
`patent by Kuhn alone or Kuhn in view of Heath or ISO 3630-1, on which the
`
`Board instituted this proceeding. See Paper 1, p. 60. Bahia and Brantley each
`
`support the fact that the ProFile instruments discussed in Kuhn are described in the
`
`art to be superelastic (prior to heat-treatment). Id. Further, Dr. Goldberg’s
`
`testimony regarding these grounds of unpatentability includes discussion of Bahia
`
`and Brantley. See Ex. 1002, ¶ 161. Since Dr. Goldberg reasonably relied upon
`
`Bahia and Brantley in forming his opinions, Bahia and Brantley are admissible
`
`under FRE 703.
`
`8
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`
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`Accordingly, Exhibits 1034 and 1038 are admissible and should not be
`
`excluded.
`
`VII. EXHIBIT 1036 IS ADMISSIBLE
`
`Exhibit 1036 is an article published in 2008, authored by M.J. Drexel et al.,
`
`and entitled, “The Effects of Cold Work and Heat Treatment on the Properties of
`
`Nitinol Wire” (“Drexel”).
`
`Patent Owner argues that Drexel is irrelevant to the proceeding because it is
`
`“not part of any instituted ground.” Paper 36, p. 6. Patent Owner also argues that
`
`Drexel is “not prior art to the ’991 patent.” Id. Patent Owner is wrong on both
`
`counts. As an initial matter, Patent Owner provides no explanation for its assertion
`
`that Drexel is “not prior art” to the ’991 patent. To the contrary, Drexel is prior art
`
`to the ’991 patent since it was published in 2008—well before the January 29,
`
`2014 effective filing date of the claims 12-16 of the ’991 patent. See Paper 17, p.
`
`21.
`
`Drexel is relevant to the ground of lack of enablement of claims 12-16 of the
`
`’991 patent, on which the Board instituted this proceeding. Specifically, Drexel
`
`discloses an example that shows that the thermal history of a Ni-Ti endodontic
`
`instrument impacts its relevant properties. See Ex. 1002, ¶ 124; see also Paper 31,
`
`p. 13-14. Since Dr. Goldberg relied upon such disclosure in Drexel in forming his
`
`9
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`
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`opinions on the necessity of undue experimentation in practicing the claims 12-16
`
`of the ’991 patent, see id., Drexel is admissible under FRE 703.
`
`Accordingly, Exhibit 1036 is admissible and should not be excluded.
`
`VIII. CONCLUSION
`
`For the foregoing reasons, Exhibits 1005, 1006, 1016, 1017, 1020, 1021,
`
`1025, 1034, 1036, and 1038 are admissible, and should not be excluded.
`
`
`
`
`
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`
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` Respectfully submitted,
`
`
`
`Dated: October 3, 2016
`
`
`
`/Jeffrey S. Ginsberg/
`
`
`Jeffrey S. Ginsberg (Reg. No. 36,148)
`Lead counsel
`
`Abhishek Bapna (Reg. No. 64,049)
`Back-up counsel
`
`Patterson Belknap Webb & Tyler LLP
`1133 Avenue of the Americas
`New York, NY 10036-6710
`Telephone: (212) 336-2000
`
`Attorneys for Petitioner US Endodontics, LLC
`
`10
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on October 3,
`
`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)
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