Filed on behalf of: Gold Standard Instruments, LLC Paper ____
`
`
`
`
` Date filed: March 23, 2016
`
`By:
`Joseph A. Hynds, Lead Counsel
`R. Elizabeth Brenner-Leifer, Back-up Counsel
`Steven Lieberman, Back-up Counsel
`Jason M. Nolan, Back-up Counsel
`Derek F. Dahlgren, Back-up Counsel
`C. Nichole Gifford, 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
` ebrenner@rothwellfigg.com
` slieberman@rothwellfigg.com
` jnolan@rothwellfigg.com
` ddahlgren@rothwellfigg.com
` ngifford@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 IPR2015-00632
`Patent 8,727,773 B2
`_______________
`
`PATENT OWNER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE
`
`
`
`
`
`
` Date filed: March 23, 2016
`
`By:
`Joseph A. Hynds, Lead Counsel
`R. Elizabeth Brenner-Leifer, Back-up Counsel
`Steven Lieberman, Back-up Counsel
`Jason M. Nolan, Back-up Counsel
`Derek F. Dahlgren, Back-up Counsel
`C. Nichole Gifford, 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
` ebrenner@rothwellfigg.com
` slieberman@rothwellfigg.com
` jnolan@rothwellfigg.com
` ddahlgren@rothwellfigg.com
` ngifford@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 IPR2015-00632
`Patent 8,727,773 B2
`_______________
`
`PATENT OWNER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE
`
`
`
`Case IPR2015-00632
`Patent 8,727,773 B2
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`I.
`
`Introduction
`
`Case IPR2015-00632
`Patent 8,727,773 B2
`
`
`Pursuant to 37 C.F.R. § 42.64(c), Patent Owner moved to: (1) exclude
`
`Exhibits 1005, 1014 and 1037; (2) strike Exhibits 1038, 2045 and 2046 at 154:12-
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`155:2; 157:20-158:15; 161:21-163:5; 66:18-67:14; and 68:3-17; and (3) strike the
`
`first paragraph on page 10 in Paper 57. (Paper 63) Petitioner opposed. (Paper 67)
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`Patent Owner hereby replies to Petitioner’s opposition.
`
`II. Exhibit 1005
`
`First, Ex. 1005 is inadmissible hearsay. Petitioner neither explains why it is
`
`not hearsay, nor alleges any exception. Instead, Petitioner argues that Dr.
`
`Goldberg’s reference to Ex. 1005 makes it admissible. Not so. While Dr. Goldberg
`
`may base his opinions on hearsay, FRE 703 does not make the hearsay itself
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`admissible. Advisory Committee Notes - 2000 Amendments (“Rule 703 has been
`
`amended to emphasize that when an expert reasonably relies on inadmissible
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`information to form an opinion or inference, the underlying information is not
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`admissible simply because the opinion or inference is admitted.”).
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`Second, Ex. 1005 is not relevant. Petitioner argues that Ex. 1005 is relevant
`
`to the knowledge of a person in the art. But differences between the cited
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`references and the claimed invention must be viewed through the lens of a person
`
`of ordinary skill in the art at the time of the invention. 35 U.S.C. § 103. Ex. 1005 is
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`dated two years after the effective priority date of the ’773 patent. It is not prior art
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`1
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`
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`and Dr. Goldberg’s reliance on Ex. 1005 highlights the improper hindsight in his
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`Case IPR2015-00632
`Patent 8,727,773 B2
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`analysis. Petitioner’s argument that a citation to an earlier Brantley 2001 article
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`makes Ex. 1005 relevant must also fail because that article is not at issue here.
`
`III. Exhibit 1014
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`Ex. 1014—which was published in 2011 and which Petitioner concedes is
`
`not prior art (Paper 67, 4)—is not relevant. Petitioner argues Ex. 1014 is relevant to
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`its theory that a file with an elevated Af temperature will exhibit permanent
`
`deformation after bending. As explained in Patent Owner’s response, Petitioner’s
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`theory is wrong, and Dr. Sinclair has explained why the theory is scientifically
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`unsound. Ex. 2026, ¶¶72-123 (Kuhn’s heat-treated files have an elevated Af and
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`exhibit minimal, if any, deformation). And evidence disproves that theory. Exs.
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`2051-2052 (files heat treated per Kuhn’s process have less than 1° of permanent
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`deformation). Further, the ’773 patent does not claim an increase in Af as
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`Petitioner erroneously argues. Petitioner also argues Ex. 1014 is relevant to
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`Matsutani and Pelton. But Ex. 1014 does not disclose heating only a tip portion of
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`a file, like Matsutani. And Pelton, which expressly aims to optimize the
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`superelasticity of NiTi wire, is not concerned with reducing superelasticity in files
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`to allow for over 10 degrees of permanent deformation after bending.
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`IV. Exhibit 1037
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`Ex. 1037 is hearsay and Petitioner does not deny that it relies on Ex. 1037
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`2
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`Case IPR2015-00632
`Patent 8,727,773 B2
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`for the truth of the matter asserted. Petitioner provides no authority establishing the
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`applicability of FRE 803(8). Even if Ex. 1037 were admissible, it is not discussed
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`in any expert declaration. So Petitioner’s discussion of Ex. 1037 in Paper 57 is
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`unsupported attorney argument that is entitled no weight. To the extent Ex. 1037 is
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`relevant, it contradicts Petitioner’s reason for modifying Matsutani, as it shows that
`
`partial heat-treatments are easy and well-known. Ex. 1037, 8:54–9:11.
`
`V. Exhibits 1038, 2045, and 2046
`
`The questions in Ex. 1038 at 66:18-67:14; 68:3-17; 154:12-155:2; 157:20-
`
`158:15; and 161:21-163:5 are outside the scope of Dr. Luebke’s direct testimony
`
`(Ex. 2027) and are inadmissible under Rule 42.53(d)(5)(D)(ii). Ex. 2027 is a
`
`factual declaration, setting out Dr. Luebke’s discovery of the claimed invention,
`
`his attempts to license and commercialize the technology, and his clarification of
`
`certain remarks made in the prosecution of a different patent. Dr. Luebke did not
`
`opine about the prior art or explain why the patents and publications cited in the
`
`Petition fail to anticipate or render obvious the invention claimed in the ’773 patent
`
`in Ex. 2027. Indeed, Petitioner’s summary of the topical headings of Dr. Luebke’s
`
`declaration (Paper 67, 7-8) do not refer to the references or patentability.
`
`Petitioner’s attempt to associate its improper questions with Dr. Luebke’s
`
`direct testimony falls short. Regarding 154:12–155:2, Petitioner argues that
`
`Matsutani “undermines [Dr. Luebke’s] statements that the ’773 patent [was] met
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`3
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`
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`with skepticism.” Paper 67, 9. That makes no sense. The skepticism expressed by
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`Case IPR2015-00632
`Patent 8,727,773 B2
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`other practitioners had nothing to do with Ex. 1023. In 2004, those doctors used
`
`conventional, superelastic files; and when they tried files made according to Dr.
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`Luebke’s claimed process, they characterized the files as “too soft” and “too
`
`weak.” Ex. 2027, ¶¶37-38. If anything, Matsutani supports the skepticism that Dr.
`
`Luebke faced because Matsutani expressly warns that heating more than a portion
`
`of the working portion of the file may lead to problems. Ex. 1023, 5:37-42.
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`Regarding 157:20-158:15, Petitioner asked Dr. Luebke about Matsutani, not shape
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`memory or root canals generally. Petitioner erroneously argues that its questions
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`show Dr. Luebke was not the first to recognize the effects of heat-treating a file.
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`But the facts are clear: Matsutani did not heat treat the entire shank. In fact,
`
`Matsutani expressly states that heating more than ¾ of the working portion may
`
`cause problems. See Ex. 1023, 5:37-42 (emphasis added):
`
`Moreover, if the length of the shape memory portion 6 is larger than
`¾ of the work portion, at the time of inserting the tip 3 into the root
`canal and rotating it, a problem may occur in that the position of a
`rotational axis is not fixed, but is made eccentric to make it
`difficult to cut the root canal well.
`Matsutani emphasizes that other than the tip, the file is superelastic. See Ex. 1023,
`
`4:65–5:6 (emphasis added):
`
`The superelastic portion 7 memorizes the shape of a straight needle
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`4
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`Case IPR2015-00632
`Patent 8,727,773 B2
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`and keeps a state where a memory shape is formed in the shape of the
`straight needle in the range of room temperature. This superelastic
`portion 7 has extremely high flexibility and high restorability. That is,
`the superelastic portion 7 is easily deformed (bent) in response to an
`external force applied thereto, but is easily restored to an original
`shape when the application of the external force is removed.
`
`Regarding 161:21–163:5, Petitioner again asked Dr. Luebke about
`
`Matsutani, which is beyond the scope of direct. Those questions had nothing to do
`
`with Dr. Luebke’s experience testing files according to the ISO. Further, Petitioner
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`now argues for the first time that Dr. Luebke was not the first to perform the ISO
`
`bend test and measure permanent deformation. But Petitioner previously
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`characterized the claimed wherein clause as an “unorthodox” metric (Pet., 9).
`
`Regarding 66:18–67:14 and 66:3-17, Petitioner’s questions concerned Kuhn,
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`not Ex. 2027, ¶¶17-20 and 22 as now alleged. Patent Owner did not waive its
`
`objection to the questions in 66:3-17. E.g. Ex. 1038, 69:17-18. Questions about
`
`Kuhn are beyond the scope of direct and Petitioner’s mischaracterization of the
`
`questions as being to the “state of the prior art” is disingenuous. Also, Petitioner’s
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`statement that Dr. Luebke was not the first to provide a NiTi file in accordance
`
`with ISO standards is beside the point. The claims relate to a process, not files.
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`VI. Conclusion
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`In sum, the Board should grant Patent Owner’s motion (Paper 63).
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`5
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`Respectfully submitted,
`
`
`
`
`
`/ Joseph A. Hynds /
`By:
`
`Date: March 23, 2016
`Joseph A. Hynds, Reg. No. 34,627
`
`
`
`
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`ROTHWELL, FIGG, ERNST &
`
`
`
`
`
`
` MANBECK, P.C.
`607 14th Street, 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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`Case IPR2015-00632
`Patent 8,727,773 B2
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`6
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`
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`CERTIFICATE OF SERVICE
`
`I hereby certify that on this 23rd day of March 2016, a true and correct copy
`
`Case IPR2015-00632
`Patent 8,727,773 B2
`
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`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.
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`
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`
`
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