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 RESPONSE TO PATENT OWNER'S
`OBSERVATIONS ON CROSS-EXAMINATION
`
`
`
`

`
`
`
`TABLE OF CONTENTS
`TABLE OF CONTENTS
`
`PAGE
`1
`
`INTRODUCTION ..................................................................................................... 1
`INTRODUCTION ................................................................................................... .. 1
`
`RESPONSES TO OBSERVATIONS ....................................................................... 2
`RESPONSES TO OBSERVATIONS ..................................................................... ..2
`
`I.
`I.
`
`OBSERVATION NO. 1 .................................................................................. 2
`OBSERVATION NO. 1 ................................................................................ ..2
`
`II.
`II.
`
`OBSERVATION NO. 2 .................................................................................. 2
`OBSERVATION NO. 2 ................................................................................ ..2
`
`III. OBSERVATION NO. 3 .................................................................................. 3
`III. OBSERVATION NO. 3 ................................................................................ ..3
`
`IV. OBSERVATION NO. 4 .................................................................................. 5
`IV. OBSERVATION NO. 4 ................................................................................ ..5
`
`V. OBSERVATION NO. 5 .................................................................................. 6
`V.
`OBSERVATION NO. 5 ................................................................................ ..6
`
`VI. OBSERVATION NO. 6 .................................................................................. 7
`VI. OBSERVATION NO. 6 ................................................................................ ..7
`
`VII. OBSERVATION NO. 7 .................................................................................. 8
`VII. OBSERVATION NO. 7 ................................................................................ .. 8
`
`VIII. OBSERVATION NO. 8 .................................................................................. 8
`VIII. OBSERVATION NO. 8 ................................................................................ ..8
`
`IX. OBSERVATION NO. 9 .................................................................................. 9
`IX. OBSERVATION NO. 9 ................................................................................ ..9
`
`X. OBSERVATION NO. 10 ................................................................................ 9
`X.
`OBSERVATION NO. 10 .............................................................................. ..9
`
`XI. OBSERVATION NO. 11 .............................................................................. 10
`XI. OBSERVATION NO. 11 ............................................................................ .. 10
`
`XII. OBSERVATION NO. 12 .............................................................................. 11
`XII. OBSERVATION NO. 12 ............................................................................ .. 11
`
`XIII. OBSERVATION NO. 13 .............................................................................. 12
`XIII. OBSERVATION NO. 13 ............................................................................ .. 12
`
`CONCLUSION ........................................................................................................ 13
`CONCLUSION ...................................................................................................... .. 13
`
`
`
`
`
`i
`
`

`
`
`
`Petitioner US Endodontics, LLC submits this Response to Patent Owner's
`
`Observations on Cross-Examination concerning the testimony of Petitioner's
`
`expert, Dr. A. Jon Goldberg, in Exhibit 2047.
`
`INTRODUCTION
`
`Since each of Patent Owner's observations improperly raises new issues, re-
`
`argues issues, does not contradict Dr. Goldberg's or Petitioner's positions,
`
`mischaracterizes Dr. Goldberg's testimony, and/or is not relevant to this
`
`proceeding, the Board should accord the observations no weight. See Medtronic,
`
`Inc. v. Nuvasive, Inc., IPR2013-00506, Paper 37, pp. 3-4 (P.T.A.B. Oct. 15, 2014)
`
`("An observation is not an opportunity to raise new issues, to re-argue issues, or to
`
`pursue objections.").
`
`Further, Patent Owner's Observation Nos. 2-7 and 13 rely upon cross-
`
`examination testimony that is the subject of Petitioner's Motion to Exclude
`
`Evidence Under 37 C.F.R. § 42.64(c), see Paper 40, pp. 6-8, for exceeding the
`
`scope of direct testimony in the Supplemental Declaration of A. Jon Goldberg,
`
`Ph.D. (Ex. 1042, hereinafter "Dr. Goldberg's Supplemental Declaration"), in
`
`violation of 37 C.F.R. § 42.53(d)(5)(ii), which requires "the scope of the [cross-
`
`examination to be] limited to the scope of the direct testimony." Accordingly, to
`
`the extent the Board grants Petitioner's motion to exclude such cross-examination
`
`testimony, it should deny Patent Owner's motion for observations of the same.
`
`1
`
`

`
`
`
`RESPONSES TO OBSERVATIONS
`
`I.
`
`OBSERVATION NO. 1
`
`This observation should be accorded no weight because it: (1) raises a new
`
`issue, and (2) does not contradict Dr. Goldberg's position that undue
`
`experimentation is needed to practice the claims of the '991 patent. Patent Owner
`
`raises a new argument that bears no relation to the direct testimony in Dr.
`
`Goldberg's Supplemental Declaration, and that Patent Owner could have, but failed
`
`to, raise in its Response. Further, in the portion of Exhibit 2047 that immediately
`
`follows the portion identified by Patent Owner, Dr. Goldberg testified that
`
`numerous variables can influence whether a bend-test would result in the claimed
`
`deformation. See Ex. 2047, 24:20-25:11. Thus, Dr. Goldberg's alleged "admission"
`
`in Exhibit 2047 at 23:24-24:19 is entirely consistent with the testimony in his
`
`declaration submitted with the Petition. See Ex. 1002, ¶¶ 111-125; Paper 31, pp.
`
`11-15.
`
`II. OBSERVATION NO. 2
`
`This observation should be accorded no weight because it: (1) re-argues an
`
`issue; (2) raises a new argument; (3) mischaracterizes Dr. Goldberg's testimony;
`
`and (4) is not relevant to this proceeding. Patent Owner already argued this issue in
`
`its Response. See Paper 27, pp. 29-30. In citing Dr. Goldberg's testimony in
`
`Exhibit 2047 at 49:9-17, Patent Owner also raises a new argument based on a
`
`2
`
`

`
`
`
`document – Exhibit 2043 : that (1) was available to Patent Owner at the time it
`
`submitted its Response, but not raised therein; (2) Dr. Goldberg had never seen
`
`prior to his cross-examination, see Ex. 2047, 46:23-47:7; and (3) bears no relation
`
`to the direct testimony in Dr. Goldberg's Supplemental Declaration. Further, this
`
`observation is based on portions of Exhibit 2043 that Patent Owner's counsel read
`
`into the record. See Ex. 2047, 48:6-18. Dr. Goldberg did not "concede[] that a
`
`nickel titanium alloy can remain superelastic below its austenite finish
`
`temperature." Rather, Dr. Goldberg testified that one can determine the crystal
`
`structure based on the Af temperature as long as one is not "totally in a void"
`
`regarding "how [the sample has] been used." Id. at 49:18-25; 58:3-5. Dr. Goldberg
`
`further testified that information regarding whether the sample was being cooled or
`
`whether it was being heated to arrive at the current temperature is generally
`
`encompassed in "how [the sample] is being used." Id. at 57:6-17. In the prior art at
`
`issue in this proceeding, Dr. Goldberg explained, "it's either been directly
`
`described or implied what the situation was." Id. at 58:13-15. Thus, Dr. Goldberg's
`
`testimony cited by Patent Owner is not relevant to, and does not detract from, his
`
`opinions that the prior art renders the claims of the '991 patent unpatentable.
`
`III. OBSERVATION NO. 3
`
`This observation should be accorded no weight because it: (1) raises a new
`
`issue; (2) mischaracterizes Dr. Goldberg's testimony; and (3) is not relevant to this
`
`3
`
`

`
`
`
`proceeding. Patent Owner raises a new argument that bears no relation to the direct
`
`testimony in Dr. Goldberg's Supplemental Declaration, and that Patent Owner
`
`could have, but failed to, raise in its Response. Patent Owner also asserts
`
`incorrectly that Petitioner's and Dr. Goldberg's position is that Exhibit 1031
`
`("McSpadden") alone renders the claims of the '991 patent obvious. Further, the
`
`fact that the prior art discloses that nickel titanium ("Ni-Ti") endodontic
`
`instruments having certain compositions and subjected to certain heat-treatments
`
`may exhibit the claimed permanent deformation does not mean that the '991 patent
`
`specification's disclosure of a single heat-treatment temperature of 500°C for a
`
`single heat-treatment time of 75 minutes to obtain the claimed deformation enables
`
`the broad scope of the claims, which claim heat-treatment temperatures of from
`
`above 25°C and from 300°C, without the need for undue experimentation.
`
`Additionally, the standards and burdens relating to enablement differ under 35
`
`U.S.C. § 112 and 35 U.S.C. § 103. See, e.g., Symbol Techs., Inc. v. Opticon, Inc.,
`
`935 F.2d 1569, 1578 (Fed. Cir. 1991) ("[A] non-enabling reference may qualify as
`
`prior art for the purpose of determining obviousness under § 103."); Beckman
`
`Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989)
`
`("Even if a reference discloses an inoperative device, it is prior art for all that it
`
`teaches."). Thus, Dr. Goldberg's testimony cited by Patent Owner is not relevant to,
`
`4
`
`

`
`
`
`and does not detract from, his opinions regarding the lack of enablement of the
`
`claims of the '991 patent. See Ex. 1002, ¶¶ 99-125.
`
`IV. OBSERVATION NO. 4
`
`This observation should be accorded no weight because it: (1) raises a new
`
`issue; (2) mischaracterizes Dr. Goldberg's testimony; and (3) is not relevant to this
`
`proceeding. Patent Owner raises a new argument that bears no relation to the direct
`
`testimony in Dr. Goldberg's Supplemental Declaration, and that Patent Owner
`
`could have, but failed to, raise in its Response. Notably, Petitioner does not rely on
`
`Exhibit 2044 ("the '815 Matsutani patent") in its Petition. Patent Owner also asserts
`
`incorrectly that Petitioner's and Dr. Goldberg's position in IPR2015-00632 was that
`
`the '815 Matsutani patent alone renders the claims of U.S. Patent No. 8,727,773
`
`patent ("the '773 patent") obvious.
`
`Further, the fact that the prior art discloses that Ni-Ti endodontic instruments
`
`having certain compositions and subjected to certain heat-treatments may exhibit
`
`the claimed permanent deformation does not mean that the '991 patent
`
`specification's disclosure of a single heat-treatment temperature of 500°C for a
`
`single heat-treatment time of 75 minutes to obtain the claimed deformation enables
`
`the broad scope of the claims, which claim heat-treatment temperatures of from
`
`above 25°C and from 300°C, without the need for undue experimentation.
`
`Additionally, the standards and burdens relating to enablement differ under 35
`
`5
`
`

`
`
`
`U.S.C. § 112 and 35 U.S.C. § 103. See, e.g., Symbol Techs., 935 F.2d at 1578;
`
`Beckman, 892 F.2d at 1551. Thus, Dr. Goldberg's "admission" is not relevant to,
`
`and does not detract from, his opinions regarding the lack of enablement of the
`
`claims of the '991 patent. See Ex. 1002, ¶¶ 99-125.
`
`V. OBSERVATION NO. 5
`
`This observation should be accorded no weight because it: (1) raises a new
`
`issue, and (2) is not relevant to this proceeding. Patent Owner raises a new
`
`argument that bears no relation to the direct testimony in Dr. Goldberg's
`
`Supplemental Declaration, and that Patent Owner could have, but failed to, raise in
`
`its Response. Further, whether a person of ordinary skill in the art would know that
`
`there are temperatures at which one could heat a Ni-Ti endodontic file to eliminate
`
`superelasticity or to make a file that deforms to some unspecified extent does not
`
`mean that the '991 patent specification's disclosure of a single heat-treatment time
`
`of 500°C for a single heat-treatment time of 75 minutes to obtain the claimed
`
`deformation enables the broad scope of the claims, which claim heat-treatment
`
`temperatures from above 25°C and from 300°C, without the need for undue
`
`experimentation. Thus, Dr. Goldberg's testimony cited by Patent Owner is not
`
`relevant to, and does not detract from, his opinions regarding the lack of
`
`enablement of the claims of the '991 patent. See Ex. 1002, ¶¶ 99-125.
`
`6
`
`

`
`
`
`VI. OBSERVATION NO. 6
`
`This observation should be accorded no weight because it: (1) raises a new
`
`issue; (2) mischaracterizes Dr. Goldberg's testimony; and (3) is not relevant to this
`
`proceeding. Patent Owner raises a new argument that bears no relation to the direct
`
`testimony in Dr. Goldberg's Supplemental Declaration, and that Patent Owner
`
`could have, but failed to, raise in its Response. Petitioner does not rely on the '815
`
`Matsutani patent in its Petition in this proceeding. Patent Owner also asserts
`
`incorrectly that Petitioner's and Dr. Goldberg's position in IPR2015-00632 is that
`
`the '815 Matsutani patent alone renders the claims of U.S. Patent No. 8,727,773
`
`patent ("the '773 patent") obvious. Further, the fact that the prior art discloses that
`
`Ni-Ti endodontic instruments having certain compositions and subjected to certain
`
`heat-treatments may exhibit the claimed permanent deformation does not mean
`
`that the '991 patent specification's disclosure of a single heat-treatment temperature
`
`of 500°C for a single heat-treatment time of 75 minutes to obtain the claimed
`
`deformation enables the broad scope of the claims, which claim heat-treatment
`
`temperatures of from above 25°C and from 300°C, without the need for undue
`
`experimentation. Additionally, the standards and burdens relating to enablement
`
`differ under 35 U.S.C. § 112 and 35 U.S.C. § 103. See, e.g., Symbol Techs., 935
`
`F.2d at 1578; Beckman, 892 F.2d at 1551. Thus, Dr. Goldberg's testimony cited by
`
`7
`
`

`
`
`
`Patent Owner is not relevant to, and does not detract from, his opinions regarding
`
`the lack of enablement of the claims of the '991 patent. See Ex. 1002, ¶¶ 99-125.
`
`VII. OBSERVATION NO. 7
`
`This observation should be accorded no weight because it: (1) raises a new
`
`issue, and (2) is not relevant to this proceeding. Patent Owner raises a new
`
`argument that bears no relation to the direct testimony in Dr. Goldberg's
`
`Supplemental Declaration, and that Patent Owner could have, but failed to, raise in
`
`its Response. Further, in Exhibit 2047 at 78:2-20, cited by Patent Owner, Dr.
`
`Goldberg testified, in a general sense, that it was fair to consider the composition
`
`range of Ni-Ti alloys that exhibit superelastic behavior narrow. Such general
`
`statement do not contradict Dr. Goldberg's opinion that small changes to
`
`composition even within the claimed range can profoundly affect the properties of
`
`Ni-Ti, and that the '991 patent specification provides no guidance in that regard.
`
`See Ex. 1002, ¶¶ 111-113. Thus, Dr. Goldberg's "admission" in Exhibit 2047 at
`
`78:2-20 is not relevant to, and does not detract from, his opinions regarding the
`
`lack of enablement of the claims of the '991 patent. See Ex. 1002, ¶¶ 99-125.
`
`VIII. OBSERVATION NO. 8
`
`This observation should be accorded no weight because it is not relevant to
`
`this proceeding. Petitioner's original testing and supplemental testing each
`
`separately confirm that heat-treatments of various duration and temperature
`
`8
`
`

`
`
`
`combinations across a significant portion of the claimed ranges fail to achieve the
`
`claimed deformation of a Ni-Ti endodontic instrument. See Paper 31, pp. 5-8. The
`
`heat-treatment parameters were dictated by the claimed parameters, and are
`
`indisputably within the claimed range. Id. at 7. Thus, Dr. Goldberg's "admission"
`
`in Exhibit 2047 at 20:13-22 is not relevant to, and does not detract from, his
`
`opinions regarding the lack of enablement of the claims of the '991 patent. See Ex.
`
`1002, ¶¶ 99-125.
`
`IX. OBSERVATION NO. 9
`
`This observation should be accorded no weight because it: (1) raises a new
`
`issue, and (2) is not relevant to this proceeding. Patent Owner raises a new
`
`argument that it could have, but failed to, raise in its Response. Further, Petitioner's
`
`original testing and supplemental testing each separately confirm that heat-
`
`treatments of various duration and temperature combinations across a significant
`
`portion of the claimed ranges fail to achieve the claimed deformation of a Ni-Ti
`
`endodontic file. See Paper 31, pp. 5-8. Thus, Dr. Goldberg's "admission" in Exhibit
`
`2047 at 68:22-69:23 does not detract from his opinions regarding the lack of
`
`enablement of the claims of the '991 patent. See Ex. 1002, ¶¶ 99-125.
`
`X. OBSERVATION NO. 10
`
`This observation should be accorded no weight because it is not relevant to
`
`this proceeding. As an initial matter, neither the ISO Standard 3630-1 (2008) nor
`
`9
`
`

`
`
`
`the '991 patent identifies the temperature at which the bend-testing should be
`
`conducted. In any event, the report from Innovative Test Solutions, Inc. ("ITS")
`
`states, "After heat treating and prior to bend testing, the samples were allowed to
`
`cool completely." Ex. 1041, p. 11 of 46. Further still, the question Dr. Goldberg
`
`was actually asked was whether he would agree that if the bend test was conducted
`
`at the elevated temperature of 40°C (104°F), one could get different results than if
`
`the bend test was conducted at 23°C (73°F or room temperature). Ex. 2014, 32:11-
`
`18. The ITS report makes clear that the samples that were heat-treated at both 40°C
`
`and 300°C were allowed to cool completely before testing. Ex. 1041, p. 11 of 46.
`
`Thus, the portions of Exhibit 2047 cited by Patent Owner are not relevant to, and
`
`do not detract from, Dr. Goldberg's opinions regarding the supplemental testing
`
`commissioned by Petitioner. See Ex. 1042.
`
`XI. OBSERVATION NO. 11
`
`This observation should be accorded no weight because it: (1)
`
`mischaracterizes Dr. Goldberg's testimony, and (2) is not relevant to this
`
`proceeding. Neither party has proposed a construction for "superelastic" in this
`
`proceeding. In Exhibit 2047 at 60:19-61:7, cited by Patent Owner in this
`
`observation, Dr. Goldberg was questioned regarding an opinion he provided in a
`
`district court action involving U.S. Patent No. 8,562,341 ("the '341 patent") and the
`
`'773 patent in which the construction of the term "superelastic" was disputed. The
`
`10
`
`

`
`
`
`construction of this term is not at issue in this proceeding, and Dr. Goldberg did
`
`not provide an opinion regarding the same. Further, the "broadest reasonable
`
`interpretation" standard for claim construction used in this proceeding is different
`
`than the Phillips standard used in district courts. See PPC Broadband, Inc. v.
`
`Corning Optical Commc'ns RF, LLC, 815 F.3d 747, 756.
`
`Moreover, the passages cited by Patent Owner do not support its assertion
`
`that Dr. Goldberg stated that the files tested in the supplemental report "are outside
`
`the scope of the claims of the '991patent." Dr. Goldberg testified that ProFile files
`
`are described as being superelastic. See Ex. 2047, 66:17-67:15; see also Ex. 1002,
`
`¶ 104. Notably, real party-in-interest and manufacturer of the ProFile files, Tulsa
`
`Dental Products LLC, markets its ProFile files as being comprised of Nitnol 55
`
`nickel titanium wire, Ex. 1002, ¶104 (citing Ex. 1035), which the applicant claimed
`
`in the '991 patent as being superelastic. See Ex. 1001, col. 4:56-59 and claim 16.
`
`Thus, the portions of Exhibit 2047 cited by Patent Owner are not relevant to, and
`
`do not detract from, Dr. Goldberg's opinions regarding the supplemental testing
`
`commissioned by Petitioner. See Ex. 1042.
`
`XII. OBSERVATION NO. 12
`
`This observation should be accorded no weight because it: (1) raises a new
`
`issue, and (2) is not relevant to this proceeding. Patent Owner raises a new
`
`argument that it could have, but failed to, raise in its Response. Further, Petitioner
`
`11
`
`

`
`
`
`has not suggested that any complexity of the bend-test recited in the claims of the
`
`'991 patent contributes to the lack of enablement of the claims or the necessity of
`
`undue experimentation. Thus, such "admission" by Dr. Goldberg is not relevant to
`
`his opinions regarding the lack of enablement of the claims of the '991 patent. See
`
`Ex. 1002, ¶¶ 99-125.
`
`XIII. OBSERVATION NO. 13
`
`This observation should be accorded no weight because it raises a new issue.
`
`Dr. Goldberg's qualifications as an expert and definition of a person of ordinary
`
`skill in the art were provided in his declaration submitted with the Petition in this
`
`proceeding. See Ex. 1002, ¶¶ 1-7, 75. Patent Owner could have, but failed to, raise
`
`an argument regarding Dr. Goldberg's qualifications and definition of a person of
`
`skill in the art in its Response. Further, in IPR2015-00632, which involved
`
`Luebke's related '773 patent, Patent Owner's expert, Dr. Robert Sinclair, opined:
`
`"I believe that a person of ordinary skill in the art would have had
`
`familiarity with nickel titanium alloys and would likely have at least a
`
`B.S. degree in material science, metallurgy, or related field and
`
`several years of experience in metallurgy and nickel titanium alloys in
`
`particular. Alternatively, a person of ordinary skill in the art could
`
`have a higher level of education and less experience or vice-versa.
`
`The relevant experience could be in industry, academia, government,
`
`private practice, a clinic or any other setting so as to provide an
`
`12
`
`

`
`
`
`understanding of the structural or mechanical properties of nickel
`
`titanium endodontic instruments."
`
`IPR2015-00632, Ex. 2026, ¶ 22. Thus, Dr. Goldberg's "admission[s]" in Exhibit
`
`2047 at 15:8-13, 18:25-19:5, and 39:18-41:8 are not relevant to, and do not detract
`
`from, his qualifications as an expert witness in this proceeding.
`
`CONCLUSION
`
`For the foregoing reasons, the Board should deny Patent Owner's motion for
`
`observations.
`
`Dated: October 3, 2016
`
`Respectfully submitted,
`
`
`
`/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
`
`13
`
`

`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on October 3,
`
`2016, the foregoing PETITIONER'S RESPONSE TO PATENT OWNER'S
`
`OBSERVATIONS ON CROSS-EXAMINATION 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)