UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`MAKO SURGICAL CORP.,
`Petitioner,
`
`v.
`
`BLUE BELT TECHNOLOGIES, INC. and
`CARNEGIE MELLON UNIVERSITY,
`Exclusive Licensee and Patent Owner.
`_____________________
`
`
`
`IPR2015-00630
`
`U.S. Patent No. 6,205,411 B1
`
`_____________________
`
`MOTION TO EXCLUDE EVIDENCE
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`MAKO SURGICAL CORP.,
`Petitioner,
`
`v.
`
`BLUE BELT TECHNOLOGIES, INC. and
`CARNEGIE MELLON UNIVERSITY,
`Exclusive Licensee and Patent Owner.
`_____________________
`
`
`
`IPR2015-00630
`
`U.S. Patent No. 6,205,411 B1
`
`_____________________
`
`MOTION TO EXCLUDE EVIDENCE
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`SUMMARY OF RELEVANT FACTS ........................................................... 1
`
`III. ARGUMENT ................................................................................................... 4
`
`IV. CONCLUSION AND RELIEF REQUESTED ............................................... 8
`
`
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`
`Ariosa Diagnostics v. Verinata Health, Inc.,
`805 F.3d 1359, 1367 (Fed. Cir. 2015) .................................................................. 5
`
`Baxter Healthcare Corp. v. Millennium Biologix, LLC,
`IPR2013-00582, Paper No. 32 (Oct. 13, 2014) ................................................ 5, 7
`
`Medtronic, Inc. v. Norred,
`IPR2014-00110, Paper No. 24 (Oct. 9, 2014) ...................................................... 5
`
`
`
`Treatises
`28 Charles Alan Wright et al., Fed. Prac. & Proc. Evid. § 6165 (2nd
`ed. 1987) ............................................................................................................... 5
`
`
`
`Regulations
`
`37 C.F.R. § 42.23(b) .................................................................................................. 5
`
`37 C.F.R. § 42.53(d)(5)(ii) ................................................................................. 1, 5, 7
`
`37 C.F.R. § 42.104(b)(5) ............................................................................................ 5
`
`
`
`ii
`
`
`
`
`
`I.
`
`Introduction
`
`Patent Owner Carnegie Mellon University and Exclusive Licensee Blue Belt
`
`Technologies, Inc. (collectively, “PO”) move to exclude the redirect testimony of
`
`Petitioner Mako Surgical Corp.’s expert, Dr. Howe. Deposition Transcript of
`
`Dr. Robert Howe, Ex. 2006 (“Howe Dep.”) at 86:22–91:3. Dr. Howe’s redirect
`
`testimony introduces, for the first time, concepts that could have been included in
`
`the Petition and/or Dr. Howe’s Declaration. But having limited the Petition and
`
`Dr. Howe’s Declaration to conclusory allegations, Petitioner cannot now overhaul
`
`its original obviousness rationale via redirect testimony from Dr. Howe.1 Rather,
`
`the scope of Dr. Howe’s redirect testimony exceeds that of his cross-examination,
`
`which was limited to Dr. Howe’s Declaration, and thus should be excluded as
`
`outside the permissible scope under 37 C.F.R. § 42.53(d)(5)(ii).
`
`II. Summary of Relevant Facts
`Independent claims 1 and 10 of U.S. Patent No. 6,205,411 (“the ’411
`
`Patent”) recite that “the pre-operative kinematic biomechanical simulator outputs a
`
`position for implantation of the artificial component.” In ¶ 38 of his Declaration,
`
`
`
` 1 Patent Owner does not concede that Dr. Howe’s redirect testimony, which is
`
`also conclusory, establishes obviousness.
`
`1
`
`
`
`
`
`Dr. Howe alleged the following to support his argument that it would have been
`
`obvious to modify DiGioia2 to meet this limitation:
`
`Claims 1 and 10 require the use of feedback from a simulator to
`output a position for implantation of the artificial component.
`Similarly, claim 7 requires the simulator to be responsive to the
`geometric model and output an implant position. The DiGioia system
`discloses that feedback from the simulator can aid the surgeon in
`determining optimal implant placement. (Ex. 1005 at 2.) It would
`have been obvious to one of skill in the art to utilize the feedback as
`suggested by DiGioia, re-run the simulation to determine optimal
`positioning of the component, and have the simulator output that
`position. In fact, this is suggested by Figure 3 in DiGioia, which
`depicts bi-directional communication between the pre-operative
`planner and the range of motion simulator.
`
`Declaration of Robert D. Howe, Ex. 1004 (“Howe Decl.”), ¶ 38. On cross-
`
`examination, PO asked Dr. Howe questions relating to the following topics:
`
`• Whether DiGioia explicitly describes a system that outputs an implant
`
`location (Howe Dep. at 56:4–10, 64:4–65:12);
`
`
` 2 A.M. DiGioia et al., HipNav: Pre-operative Planning and Intraoperative
`
`Navigational Guidance for Acetabular Implant Placement in Total Hip
`
`Replacement Surgery, 2nd CAOS Symposium, 1996, Ex. 1005.
`
`
`
`2
`
`
`
`
`
`• Whether Dr. Howe believes it would have been obvious to modify
`
`DiGioia’s system so that it outputs an implant location (id. at 56:11–14);
`
`• What evidentiary support, if any, Dr. Howe relied on to support his
`
`conclusion in ¶ 38 (id. at 56:15–59:21);
`
`• Whether Figure 3 of DiGioia shows “bidirectional communication” (id.
`
`at 59:22–63:21);
`
`• Whether Dr. Howe’s proposed modifications would require numerous
`
`software changes (id. at 63:22–64:3) (Dr. Howe did not substantively
`
`answer this question, see id at 64:3);
`
`• Whether a surgeon’s input is important in determining an implant
`
`location (id. at 65:13–66:3);
`
`• Whether human surgeons exercise better judgment and are better at
`
`qualitative analysis than computers (id. at 66:4–69:24); and
`
`• Whether Dr. Howe’s paper Robotics for Surgery3 described the system of
`
`DiGioia as outputting an implant location or suggested such a
`
`modification (id. at 69:25–74:14).
`
`
`
` 3 Robert D. Howe & Yoky Matsuoka, Robotics for Surgery, Annu. Rev. Biomed
`
`Eng., 212–40 (1999), Ex. 2001.
`
`
`
`3
`
`
`
`
`
`On redirect, Dr. Howe was asked:
`
`• “Can you explain why you believe it would have been obvious for the
`
`system to suggest an optimum implant location?” (id. at 87:11–88:8);
`
`• “What do you mean by a low-dimensional space?” (id. at 88:9–24);
`
`• “And what do you mean by high-quality objective functioning?” (id. at
`
`88:25–89:13);
`
`• “And I believe you mentioned well-known optimization techniques. Can
`
`you explain what well-known optimization techniques one of skill in the
`
`art could bring to bear on this problem?” (id. at 89:14–90:14); and
`
`• “And were those techniques known in the 1996, ’97 time frame?” (id. at
`
`90:15–91:2).
`
`On re-cross, Dr. Howe stated that his explanation on redirect was not included in
`
`his Declaration. Id. at 91:6–9. PO objected to Dr. Howe’s redirect testimony as
`
`being beyond the scope of the cross-examination during Dr. Howe’s deposition.
`
`Id. at 88:11–12, 89:3, 89:18, 90:18. Petitioner nevertheless relied on Dr. Howe’s
`
`redirect testimony in support of its obviousness arguments in its Reply.
`
`Petitioner’s Reply, Paper No. 23 (Feb. 19, 2016) at 17–18.
`
`III. Argument
`Dr. Howe’s redirect testimony does not rebut or clarify from his cross-
`
`examination, but rather impermissibly raises new issues to this proceeding, bearing
`
`
`
`4
`
`
`
`
`
`on the rational underpinning for Petitioner’s obviousness ground. Baxter
`
`Healthcare Corp. v. Millennium Biologix, LLC, IPR2013-00582, Paper No. 32 at
`
`6–7 (Oct. 13, 2014) (“Baxter Healthcare”); see also Ariosa Diagnostics v.
`
`Verinata Health, Inc., 805 F.3d 1359, 1367 (Fed. Cir. 2015) (“the challenger [is]
`
`obliged to make an adequate case in its Petition.” (citing 37 C.F.R.
`
`§§ 42.104(b)(5), 42.23(b))). Thus, Dr. Howe’s redirect testimony should be
`
`excluded as exceeding the scope of the cross-examination, which was limited to
`
`Dr. Howe’s Declaration. See 37 C.F.R. § 42.53(d)(5)(ii).4
`
`Paragraph 38 of Dr. Howe’s Declaration provides conclusory allegations
`
`insufficient to establish that it would have been obvious to modify DiGioia’s
`
`system. PO’s questions on cross-examination were specifically targeted to these
`
`allegations. For example, the third sentence of ¶ 38 characterizes DiGioia’s
`
`
`
` 4 Like Fed. R. Evid. 611(b), § 42.53(d)(5)(ii) explicitly refers to the scope of
`
`cross-examination. But courts have applied Fed. R. Evid. 611 to limit the scope
`
`of redirect testimony as well, and § 42.53(d)(5)(ii) should be applied similarly.
`
`28 Charles Alan Wright et al., Fed. Prac. & Proc. Evid. § 6165 (2nd ed. 1987);
`
`see also Medtronic, Inc. v. Norred, IPR2014-00110, Paper No. 24 at 3 (Oct. 9,
`
`2014) (limiting the scope of redirect testimony to that of cross-examination).
`
`
`
`5
`
`
`
`
`
`disclosure, and thus on cross-examination, PO asked Dr. Howe whether DiGioia
`
`explicitly describes outputting an implant location, whether he asserts such a
`
`system would be obvious, and what evidentiary support, in any, he cited for his
`
`assertion in ¶ 38. Howe Dep. at 56:4–59:21, 64:4–65:12. The next sentence of
`
`¶ 38 alleges that it would have been obvious to modify DiGioia, and so PO asked
`
`Dr. Howe about whether such a modification would require numerous changes
`
`(which he did not substantively answer), whether human (e.g., surgeon) input can
`
`be important in determining an implant location, and whether Dr. Howe’s 1999
`
`paper Robotics for Surgery states or suggests that the modification that Dr. Howe
`
`proposes in ¶ 38. Id. at 63:22–64:3, 65:13–74:14. Finally, PO asked Dr. Howe
`
`whether Figure 3 of DiGioia discloses “bidirectional communication” as he alleged
`
`in the last sentence of ¶ 38. Id. at 59:22–63:21
`
`On redirect, Dr. Howe was not asked to comment on or clarify any of his
`
`answers to the questions he was asked on cross-examination. Instead, he was
`
`asked: “Can you explain why you believe it would have been obvious for the
`
`system to suggest an optimum implant location?” Id. at 87:11–13. Dr. Howe’s
`
`answer included numerous topics not mentioned during the cross-examination,
`
`including a “high quality objective function,” id. at 87:25–88:1; a “brute force”
`
`optimization technique, id. at 89:19; and a “gradient descent” optimization
`
`technique, id. at 89:24–25. Indeed, on re-cross, Dr. Howe acknowledged that none
`
`
`
`6
`
`
`
`
`
`of his allegations in his redirect testimony were included in his Declaration. Id. at
`
`91:6–9.
`
`
`
`By choosing to introduce a new obviousness rationale via Dr. Howe’s
`
`redirect testimony, Petitioner prevented PO from introducing evidence, such as a
`
`declaration from its expert Dr. Cleary, to rebut Dr. Howe’s allegations. Dr.
`
`Howe’s redirect testimony also forces PO to expend further resources rebutting a
`
`new obviousness rationale. Baxter Healthcare at 7 (“We believe it is unfair to
`
`Patent Owner, and not in the interests of justice at this late stage of the case to
`
`impose additional time and financial burdens on Patent Owner to respond to
`
`Petitioner’s new evidence.”). On the other hand, Petitioner suffers no prejudice
`
`from being limited to its original obviousness rationale because nothing prevented
`
`Petitioner from including the substance of Dr. Howe’s redirect testimony in the
`
`Petition. Indeed, on re-cross, PO asked Dr. Howe whether there was any reason
`
`why he was “precluded from providing a detailed opinion about obviousness.” Dr.
`
`Howe replied: “Well, succinctness, you know, there’s a premium on providing,
`
`you know, a clear and succinct document.” Howe Dep. 91:10–15. The Board
`
`should thus reject Petitioner’s attempt to rewrite its obviousness rationale at this
`
`stage, and exclude Dr. Howe’s redirect testimony under 37 C.F.R. § 42.53(d)(5)(ii)
`
`as being beyond the scope of the cross-examination.
`
`
`
`
`
`7
`
`
`
`
`
`
`
`IV. Conclusion and Relief Requested
`For the forgoing reasons, PO respectfully requests that the Board exclude
`
`Dr. Howe’s redirect testimony.
`
`Dated: March 9, 2016
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`
`
`
`
`
`By: /Brian M. Buroker/
`
`
`
`Brian M. Buroker (Reg. No. 39,125) (lead)
`GIBSON, DUNN & CRUTCHER LLP
`1050 Connecticut Avenue, N.W.
`Washington, DC 20036-5306
`Telephone: 202.955.8500
`Facsimile: 202.467.0539
`bburoker@gibsondunn.com
`Attorney for Exclusive Licensee Blue Belt
`Technologies, Inc.
`
`8
`
`
`
`
`
`
`
`CERFITICATE OF SERVICE
`
`The undersigned certifies service, pursuant to 37 C.F.R. § 42.6(e), of a copy
`
`of this Motion to Exclude by electronic mail on March 9, 2016 on the counsel of
`
`record of the Petitioner:
`
`Matthew I. Kreeger, mkreeger@mofo.com
`
`Walter Wu, wwu@mofo.com
`
`
`
`Dated: March 9, 2016
`
`
`
`By: /Brian M. Buroker/
`
`
`
`
`
`Brian M. Buroker (Reg. No. 39,125)
`GIBSON, DUNN & CRUTCHER LLP
`1050 Connecticut Avenue, N.W.
`Washington, DC 20036-5306
`Telephone: 202.955.8500
`Facsimile: 202.467.0539
`bburoker@gibsondunn.com
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