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`Filed on behalf of: Gold Standard Instruments, LLC Paper ____
`
`
`
`
` Date filed: September 20, 2016
`By:
`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@rfem.com
`
` slieberman@rfem.com
`
` ngifford@rfem.com
` ebrenner@rothwellfigg.com
` ddahlgren@rfem.com
` jnolan@rfem.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 OBSERVATIONS ON CROSS-EXAMINATION
`
`
`
`
`
`Observations Regarding Goldberg
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`1.
`
`At Ex. 2047, 23:24–24:19, Dr. Goldberg admitted that his opinion
`
`regarding alleged undue experimentation being needed to practice the claims of the
`
`ʼ991 patent is based on the volume of testing that would be allegedly required.
`
`This is relevant to Dr. Goldberg and Petitioner’s assertion that undue
`
`experimentation is needed to practice the claims of the ʼ991 patent. See, e.g.,
`
`Petitioner’s Reply in Support of Post-Grant Review at 10–15.
`
`
`
`2.
`
`At Ex. 2047, 45:24–46:15, Dr. Goldberg initially stated that one can
`
`predict crystal structure based on the austenite finish temperature. However, at Ex.
`
`2047, 49:9–17 Dr. Goldberg conceded that a nickel titanium alloy can remain
`
`superelastic below its austenite finish temperature and at Ex. 2047, 51:18–52:2 and
`
`57:18–58:5, Dr. Goldberg stated that you cannot use the austenite finish
`
`temperature by itself to determine the crystal structure of a nickel titanium alloy.
`
`See also Ex. 2047, 53:8–18 (noting that crystal structure will depend on whether
`
`the sample was cooled or heated to its present temperature where there is a
`
`hysteresis between the martensite and austenite transition temperatures) and 55:13–
`
`56:2 (austenite finish temperature not sufficient by itself to predict crystal
`
`structure). This is relevant to Dr. Goldberg’s credibility, and because of Dr.
`
`Goldberg’s and Petitioner’s proposed claim construction that the “wherein clause”
`
`
`
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`
`
`
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`of the claims of the ʼ991 patent is allegedly satisfied by having an austenite finish
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`Case PGR2015-00019
`Patent 8,876,991 B2
`
`temperature greater than 37 °C. See, e.g., Ex. 1002, ¶¶ 34, 39.
`
`
`
`3.
`
`At Ex. 2047, 153:16–155:6, Dr. Goldberg states that U.S. Patent
`
`Application Publication No. 2002/0137008 to McSpadden (Ex. 1031) does not
`
`disclose times or temperatures for heating, but nonetheless provides enough
`
`information to allow one skilled in the art to make a file that is capable of being
`
`precurved without resorting to difficult experimentation.1 This is relevant because
`
`Dr. Goldberg and Petitioner have taken the position that Ex. 1031 renders the
`
`claims of the ʼ991 patent obvious—impliedly conceding that Ex. 1031 is
`
`enabling—while also arguing that the claims of the ʼ991 patent are not enabled.
`
`See, e.g., Petitioner’s Reply in Support of Post-Grant Review at 10–15.
`
`
`
`4.
`
`At Ex. 2047, 127:20–129:20, Dr. Goldberg admitted that Ex. 2044—
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`U.S. Patent No. 7,137,815 to Matsutani et al. (“Matsutani”)—does not disclose
`
`specific times or temperatures for heat treatments to remove superelasticity from a
`
`
`1 Patent Owner’s position is that the reference to shape setting in Ex. 1031 is
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`different than the claimed heat treatments in the ʼ991 patent; however, Petitioner
`
`has taken the position that Ex. 1031’s reference to setting a “pre-curved” shape is
`
`relevant to the ʼ991 patent’s claims. See, e.g., Ex. 1002, ¶¶83, 180 and Petition at
`
`66–67.
`
`
`
`2
`
`
`
`
`portion of a nickel titanium shank, does not disclose compositions for nickel
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`titanium alloys aside from a general reference to superelastic nickel titanium, and
`
`does not disclose how heat treatments should be varied depending on variations in
`
`compositions or prior processing of the files. See also Ex. 2047, 99:25–101:5,
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`101:19–103:2, 103:18–104:14. At Ex. 2047, 138:4–139:11, Dr. Goldberg stated
`
`that the ʼ991 patent provided more information regarding heating times and
`
`temperatures, as well as nickel titanium compositions, than Matsutani. This is
`
`relevant because Dr. Goldberg and Petitioner have taken the position that
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`Matsutani renders claims of Dr. Luebke’s related U.S. Patent No. 8,727,773
`
`obvious in IPR2015-00632, which was adopted by this same Panel—impliedly
`
`conceding that Matsutani is enabling—yet Dr. Goldberg and Petitioner are also
`
`arguing that the claims of the ʼ991 patent are not enabled. See, e.g., Petitioner’s
`
`Reply in Support of Post-Grant Review at 10–15.
`
`5.
`
`At Ex. 2047, 144:2–20, Dr. Goldberg stated that a person of skill in
`
`the art would know that there are temperatures that one could use for nickel
`
`titanium endodontic files to eliminate superelasticity. See also Ex. 2047, 148:15–
`
`150:3 (Dr. Goldberg agreeing that Matsutani, which discloses no heat treatment
`
`temperatures or times, composition information or prior processing history,
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`nonetheless provides enough guidance to a person of skill in the art to make a
`
`
`
`3
`
`
`
`
`deformable file with only limited experimentation), 152:17–153:15 (same and
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`Case PGR2015-00019
`Patent 8,876,991 B2
`
`noting that was the case as of 2004), and 155:7–18 (same and noting any
`
`experimentation would not be difficult). This is relevant because Dr. Goldberg and
`
`Petitioner are arguing that the claims of the ʼ991 patent are not enabled based on
`
`the disclosure of the ʼ991 patent and the knowledge of one skilled in the art, and
`
`that undue experimentation would be needed to practice the claims. See, e.g.,
`
`Petitioner’s Reply in Support of Post-Grant Review at 10–15.
`
`6.
`
`At Ex. 2047, 103:23–24, Dr. Goldberg stated that Matsutani just
`
`specifies a desired outcome. See also Ex. 2047, 104:10–14. At Ex. 2047, 104:15–
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`21, Dr. Goldberg also stated that the ʼ991 patent states a desired outcome of
`
`achieving greater than 10 degrees of permanent deformation. At Ex. 2047, 138:4–
`
`139:11, Dr. Goldberg stated that the ʼ991 patent provided more information
`
`regarding heating times and temperatures, as well as nickel titanium compositions,
`
`than Matsutani. This is relevant because Dr. Goldberg and Petitioner have taken
`
`the position in IPR2015-00632 that Matsutani renders the claims in related U.S.
`
`Patent No. 8,727,773 obvious—again, impliedly conceding that Matsutani is
`
`enabling—while arguing in this proceeding that the claims of the ʼ991 patent are
`
`not enabled. See, e.g., Petitioner’s Reply in Support of Post-Grant Review at 10–
`
`15.
`
`
`
`4
`
`
`
`7.
`
`At Ex. 2047, 78:2–20, Dr. Goldberg admitted that only a narrow range
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`
`of nickel titanium alloys exhibit superelastic behavior and that the claims of the
`
`ʼ991 patent require superelastic nickel titanium alloy. This is relevant because Dr.
`
`Goldberg and Petitioner are asserting that the claims are not enabled due to the
`
`range of compositions covered by the claims. See, e.g., Petitioner’s Reply in
`
`Support of Post-Grant Review at 10–15.
`
`8.
`
`At Ex. 2047, 20:13–22, Dr. Goldberg admitted that he did not choose
`
`the times and temperatures used for Petitioner’s supplemental testing conducted by
`
`Innovative Test Solutions LLC (“ITS”) and did not know if a metallurgist had
`
`selected the heating parameters. This is relevant because Petitioner has presented
`
`no evidence that a person of skill in the art selected the parameters used for its heat
`
`treatment experiments and it is using those experiments to support its arguments
`
`concerning alleged lack of enablement of the claims of the ʼ991 patent. See, e.g.,
`
`Petitioner’s Reply in Support of Post-Grant Review at 7, 10.
`
`9.
`
`At Ex. 2047, 68:22–69:23, Dr. Goldberg admitted that he and
`
`Petitioner had not done any testing in this post-grant review on endodontic files
`
`heated at 400ºC, 500ºC, 600ºC, 700ºC, or 800ºC. This is relevant to Dr. Goldberg
`
`and Petitioner’s contention that an allegedly significant portion of the alleged
`
`temperature ranges recited in the claims do not achieve the requisite degree of
`
`
`
`5
`
`
`
`
`permanent deformation, see, e.g., Petitioner’s Reply in Support of Post-Grant
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`Review at 2–3, and to the sufficiency of the testing presented by Dr. Goldberg and
`
`Petitioner.
`
`10.
`
`At Ex. 2047, 32:7–21 and 33:9–13 Dr. Goldberg stated that he did not
`
`recall the temperature conditions used by ITS while conducting the bend testing set
`
`forth in the supplemental report and that varying the temperature conditions could
`
`change the results of the bend testing. See also Ex. 2047, 186:11–21 (Dr.
`
`Goldberg stating that the report by ITS (Ex. 1041) does not state the temperature
`
`conditions under which the bend testing was performed and that variations in those
`
`conditions could affect the results). This is relevant to the weight that should be
`
`given to the supplemental testing relied on by Dr. Goldberg and Petitioner. See,
`
`e.g., Petitioner’s Reply in Support of Post-Grant Review at 5–8.
`
`11.
`
`At Ex. 2047, 60:19–61:7, Dr. Goldberg stated that in his opinion the
`
`term superelastic as recited in the claims of the ʼ991 patent requires 100 percent
`
`recovery, and at 67:19–68:4, Dr. Goldberg stated that the files tested in the
`
`supplemental report by ITS are outside the scope of the claims of the ʼ991 patent
`
`using his construction of the term superelastic. This is relevant to Dr. Goldberg’s
`
`and Petitioner’s reliance on the supplemental testing data in support of their
`
`
`
`6
`
`
`
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`arguments concerning enablement. See, e.g., Petitioner’s Reply in Support of Post-
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`Grant Review at 5–8.
`
`12.
`
`At Ex. 2047, 14:6–14, Dr. Goldberg admitted that the stiffness testing
`
`in Section 7.5 of the ISO Standard 3630-1 is a routine testing method. This is
`
`relevant because Dr. Goldberg and Petitioner are stating that the alleged
`
`experimentation needed to practice the challenged claims of U.S. Patent No.
`
`8,876,991 (the “ʼ991 patent”) would have been undue to a person of skill in the art.
`
`See, e.g., Petitioner’s Reply in Support of Post-Grant Review at 12.
`
`13.
`
`At Ex. 2047, 15:8–13, Dr. Goldberg admitted that he is not
`
`knowledgeable about standard testing procedures used by manufacturers of
`
`endodontic instruments. At Ex. 2047, 18:25–19:5, Dr. Goldberg admitted that he
`
`does not know whether commercially sold endodontic files are required to comply
`
`with ISO Standard 3630-1. At Ex. 2047, 39:18–41:8, Dr. Goldberg admitted that
`
`he has never been involved in flute or taper design for endodontic files, has not
`
`been involved in endodontic file design, and that his experience relates to
`
`orthodontic wire which are used differently than files and have different design
`
`factors. This is relevant to Dr. Goldberg’s qualifications as an alleged person of
`
`skill in the art and the weight that should be accorded to his opinions
`
`
`
`
`
`7
`
`
`
`
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`
`Respectfully submitted,
`
`
`
`
`
`/ Joseph A. Hynds /
`By:
`Date: September 20, 2016
`Joseph A. Hynds, Reg. No. 34,627
`
`
`
`
`
`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
`
`
`
`8
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`I hereby certify that on this 20th day of September, 2016, a true and correct
`
`copy of the foregoing PATENT OWNER GOLD STANDARD
`
`INSTRUMENTS, LLC’S OBSERVATIONS ON CROSS-EXAMINATION
`
`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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`
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