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Filed on behalf of: Gold Standard Instruments, LLC
`
`By:
`
` Paper ____
`
`
`
`
`
`
`
`
`
`
`
`
`
` Date filed: Oct. 7, 2016
`
`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
`
` slieberman@rothwellfigg.com
` ngifford@rothwellfigg.com
` ebrenner@rothwellfigg.com
` ddahlgren@rothwellfigg.com
` jnolan@rothwellfigg.com
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`v.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`_______________
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`_______________
`
`PATENT OWNER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE
`
`
`

`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`ii
`
`

`
`I.
`
`Introduction
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`Patent Owner Gold Standard Instruments, LLC (“GSI”), moved to exclude
`
`Exhibits 1005, 1006, 1016, 1017, 1020, 1021, 1025, 1034, 1036, and 1038 in Paper
`
`36. GSI hereby replies to Petitioner’s opposition (Paper 44).
`
`II. Exhibit 1005 is inadmissible hearsay
`
`
`Petitioner neither explains why Ex. 1005 is not hearsay, nor denies that it is
`
`relied on for the truth of the matter asserted. Nor does Petitioner allege any
`
`exception. Instead, Petitioner argues that Dr. Goldberg’s reference to Ex. 1005
`
`makes it admissible. Not so. Fed. R. Evid. 703 does not make the hearsay itself
`
`admissible. See Advisory Committee Notes—2000 Amendments (“Rule 703 has
`
`been amended to emphasize that when an expert reasonably relies on inadmissible
`
`information to form an opinion or inference, the underlying information is not
`
`admissible simply because the opinion or inference is admitted.”). Because Fed. R.
`
`Evid. 703 was not intended to be a vehicle for evading the prohibition against
`
`hearsay, Ex. 1005 should be excluded.
`
`Petitioner also argues that even if Ex. 1005 is hearsay, it was relied on to
`
`show that a person having ordinary skill in the art would look beyond the nickel
`
`titanium endodontic field when solving problems with endodontic instruments. But
`
`even assuming as much, whether a reference is “analogous art” is not an issue in
`
`this trial. Therefore, Ex. 1005 has no probative value in helping the Board evaluate
`1
`
`

`
`Dr. Goldberg’s opinions. The exhibit should be excluded.
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`III. Exhibits 1005, 1017, 1025, 1034, and 1036 are not prior art, and are not
`relevant
`
`Exhibits 1005, 1017, 1025, 1034, and 1036 are not prior art. Petitioner
`
`argues that GSI has not explained why Exs.1005, 1017, 1025, 1034, and 1036 are
`
`not prior art to US 8,876,991 (“the ’991 patent”). Petitioner is incorrect. As
`
`explained in Patent Owner’s Preliminary Response (Paper 14 at 31) and Patent
`
`Owner’s Response (Paper 27 at 39–40), the ’991 patent is entitled to an effective
`
`filing date of at least June 7, 2005. Because Exs.1005, 1017, 1025, 1034, and 1036
`
`were published after June 7, 2005, they are not prior art.
`
`The claimed invention must be viewed from the perspective of a person of
`
`ordinary skill in the art at the time of the invention or filing. See, e.g., Allergan, Inc.
`
`v. Sandoz Inc., 796 F.3d 1293, 1304 (Fed. Cir. 2015) (obviousness); id. at 1308
`
`(written description); Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1254 (Fed.
`
`Cir. 2004) (enablement). Petitioner has not alleged any exception to this rule. Thus,
`
`Exs.1005, 1017, 1025, 1034, and 1036 are not relevant to any instituted ground.
`
`Further, because Dr. Goldberg allegedly relied on these post-filing references in
`
`forming his opinions, his opinions are from the perspective of a person after the
`
`time of invention and/or filing. That is, Dr. Goldberg’s opinions are based on
`
`improper hindsight, which renders the exhibits prejudicial to GSI. Thus, these
`
`2
`
`

`
`exhibits should be excluded.
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`IV. Exhibits 1005, 1006, 1016, 1017, 1020, 1021, 1025, 1034, 1036, and 1038
`are not part of any instituted grounds, nor relevant
`
`Petitioner argues that Ex. 1005 is relevant to the knowledge of a person of
`
`
`
`skill in the art. Specifically, Petitioner argues that Ex. 1005 is relevant to its theory
`
`that a file with an elevated austenitic finish (Af) temperature will exhibit permanent
`
`deformation after bending. Petitioner’s argument lacks merit for three reasons.
`
`First, it ignores the Board’s finding that the relationship between Af temperature
`
`and permanent deformation is “too attenuated.” Paper 17 at 24. Second, it also
`
`ignores the fact that none of the claims in the ’991 patent refer to Af temperature.
`
`Indeed, Af temperature is not mentioned anywhere in the ’991 patent. Third,
`
`Dr. Goldberg conceded that the correlation Petitioner attempts to draw between Af
`
`temperature, crystal structure, and permanent deformation is overstated. See Paper
`
`37, ¶2 (citing, e.g., Ex. 2047 at 49:9–17 (“Q. And so the question was is it fair to
`
`say that Exhibit 2043 at column 1, lines 22 to 30 stating that a nickel titanium alloy
`
`can be austenitic when it is below its A sub F, so long as it is above the martensitic
`
`start temperature? . . . A. Yes.”)). Ex. 1005 is not relevant and should be excluded.
`
`Petitioner also argues that Exs. 1006, 1016, 1017, 1020, 1021, and 1036 are
`
`relevant to enablement. However, except for a small portion of Dr. Goldberg’s
`
`declaration citing Ex. 1006 (Paper 17 at 14), the Board did not rely on Exs. 1006,
`
`3
`
`

`
`1016, 1017, 1020, 1021, and 1036 when it instituted the ground directed to
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`enablement. See Paper 17 at 5–6. Presumably, this was because Petitioner’s
`
`nonenablement argument focused on the alleged range of temperatures at which
`
`the heat treatment occurs, the testing results in Ex. 1018, and Dr. Goldberg’s
`
`conclusory statements with respect to alleged undue experimentation. Id. at 13–15.
`
`Further, none of these exhibits disclose the heat treatment of a superelastic nickel
`
`titanium endodontic file, subsequent bending according to the stiffness/flexibility
`
`test described in ISO 3630-1, and the measurement of an angle of permanent
`
`deformation. According, none of Exs. 1006, 1016, 1017, 1020, 1021, and 1036 are
`
`probative of alleged undue experimentation with respect to the ’991 patent.
`
`Petitioner argues that Ex. 1025 is relevant to written description and cites to
`
`the following sentence in Dr. Goldberg’s declaration: “Viewed alone, the
`
`permanent deformability embodied in the ‘wherein’ clause existed in the prior art.”
`
`Ex. 1002, ¶127 (emphasis added). Petitioner, however, fails to explain why
`
`Dr. Goldberg’s fragmented analysis and reference to Ex. 1025 is relevant to
`
`whether Dr. Luebke was in possession of the claimed invention on or before June
`
`7, 2005. See Paper at 16 (“As Patent Owner correctly notes, “the written
`
`description requirement of § 112 is a ‘possession’ test.”) (citing Paper 27, p. 35).
`
`Ex. 1025 is not relevant to the test for written description, which “requires an
`
`objective inquiry into the four corners of the specification from the perspective of a
`4
`
`

`
`person of ordinary skill in the art,” and should be excluded. Ariad Pharm. Inc., v.
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).
`
`Petitioner argues that Exs. 1034 and 1038 are relevant to anticipation and
`
`obviousness. This argument also lacks merit because Exs. 1034 and 1038 were not
`
`included in any ground alleging anticipation or obviousness. See Paper 17 at 5–6.
`
`Finally, Petitioner argues that Dr. Goldberg’s reliance on Exs. 1005, 1006,
`
`1016, 1017, 1020, 1021, 1025, 1034, 1036, and 1038 in his declaration makes the
`
`exhibits relevant to the issues in the instituted grounds. As explained above,
`
`however, Fed. R. Evid. 703 was amended “to emphasize that when an expert
`
`reasonably relies on inadmissible information to form an opinion or inference, the
`
`underlying information is not admissible simply because the opinion or inference is
`
`admitted.” Advisory Committee Notes—2000 Amendments. Because the
`
`admissibility of these exhibits is distinct from the admissibility of Dr. Goldberg’s
`
`opinions, Petitioner’s argument should be rejected.
`
`V. Conclusion
`
`Based on the foregoing, the Board should exclude Exhibits 1005, 1006,
`
`1016, 1017, 1020, 1021, 1025, 1034, 1036, and 1038.
`
`5
`
`
`
`

`
`
`
`
`
`
`
`Dated: Oct. 7, 2016
`
`
`
`
`
`
`
`
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`Respectfully submitted,
`
`
`
`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
`
`6
`
`

`
`CERTIFICATE OF SERVICE
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`I hereby certify that on this 7th day of October 2016, a true and correct copy
`
`of the foregoing PATENT OWNER’S REPLY IN SUPPORT OF ITS MOTION TO
`
`EXCLUDE was served, via electronic mail upon the following counsel for
`
`Petitioner US Endodontics, LLC:
`
`Jeffrey S. Ginsberg, Esq.
`Abhishek Bapna, Esq.
`Patterson Belknap Webb & Tyler LLP
`1133 Avenue of the Americas
`New York, NY 10036-6710
`Phone: 212-336-2630
`Facsimile: 212-336-1270
`Emails: jginsberg@pbwt.com
`abapna@pbwt.com
`
`
`
`
`/ Erik van Leeuwen /
`Erik van Leeuwen
`Litigation Operations Coordinator
`Rothwell, Figg, Ernst & Manbeck, P.C.
`
`
`
`
`
`1

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