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Filed on behalf of:
`Edwards Lifesciences Corporation
`By: Craig S. Summers
`Brenton R. Babcock
`Christy G. Lea
`Joshua Stowell
`Cheryl T. Burgess
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`Email: BoxEdwards-4@knobbe.com
`
`
`
`
`
`
`
`
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. IPR2017-00444
`Patent 6,915,560
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S
`MOTION FOR OBSERVATIONS ON CROSS-EXAMINATION
`
`

`

`IPR2017-00444
`Edwards v. Boston Scientific
`
`Petitioner Edwards Lifesciences Corporation (“Edwards”) submits the
`
`following Response to Patent Owner Boston Scientific Scimed, Inc.’s (“Boston’s”)
`
`Motion for Observations on Cross-Examination (Paper No. 26). As set forth
`
`below, with few exceptions, Boston’s descriptions and characterizations of Mr.
`
`Sheehan’s testimony are either incomplete, inaccurate, or take Mr. Sheehan’s
`
`testimony out of context. Accordingly, Edwards generally disagrees with Boston’s
`
`observations regarding the relevance of Mr. Sheehan’s testimony, and, for certain
`
`observations noted below, Edwards believes such observations are irrelevant.
`
`Response to Observation 1: Edwards does not dispute that Mr. Sheehan testified
`
`that he removed stents from balloon catheters for the matter Medtronic Vascular
`
`Inc. et al. v. Boston Scientific Corp. et al. (E.D. Tex. 2006) in the year 2005 or
`
`2006. Ex. 2052 at 9:17-10:25.
`
`Response to Observation 2: Boston’s description of Mr. Sheehan’s testimony is
`
`incomplete. While Mr. Sheehan testified that he did not crimp the TriReme
`
`“constrained structure on a balloon catheter,” he also testified that he had
`
`personally observed the crimping procedure. Ex. 2052 at 14:4-10.
`
`Response to Observation 3: Boston’s description of Mr. Sheehan’s testimony is
`
`inaccurate and incomplete. Mr. Sheehan did not testify, as Boston contends, that
`
`“only Figure 9 of Yasumi relates to a pin connector.” Mr. Sheehan testified at
`
`length (Ex. 2052 at 15:15-20:1) that Yasumi’s specification discloses the use of the
`
`1
`
`

`

`IPR2017-00444
`Edwards v. Boston Scientific
`
`Figure 8 embodiment with a “linear member,” which a POSITA would understand
`
`to include a pin connector, as well as a number of things. See e.g., id. at 17:21-23
`
`(“let’s say the device in figure 8, you can do the exact same thing in figure 8. You
`
`can crimp a wire onto a pin. That’s crimping.”); id. at 16:11 (“Well, you can do it
`
`in figure 8.”); id. at 18:3-6 (“I know that in the specifications, there are references
`
`to different kinds of linear members, and so that would catch -- the phrase “linear
`
`member,’ that would catch everything.”); id. at 23:10-14 (“So one of ordinary skill
`
`in the art would understand that any reference in this patent to crimping a wire or
`
`shaping a wire is in the context of crimping that wire inside of a pin
`
`connector….”).
`
`Response to Observation 4: Boston’s description of Mr. Sheehan’s testimony is
`
`inaccurate and incomplete. The actual testimony reads:
`
`Q. In that sentence, electric wire is the only example of a linear member
`
`given, correct?
`
`A. Well, it says ‘or the like.’ So the answer to that is no, but it’s the only –
`
`it’s the only object described with absolute specificity. No problem with
`
`that.
`
`Ex. 2052 at 27:20-25.
`
`Response to Observation 5: Boston’s characterization of Mr. Sheehan’s
`
`testimony is inaccurate. Mr. Sheehan pointed to several portions of column 8 that
`
`2
`
`

`

`IPR2017-00444
`Edwards v. Boston Scientific
`
`explain how Yasumi’s movable handle 37 is coupled to the setting piece 32. Ex.
`
`2052 at 28:6-32:16. For example, Mr. Sheehan specifically identified portions of
`
`Yasumi’s specification beginning at column 8, lines 10, 12, and 22. Id. at 30:4-10,
`
`31:25-32:16. Mr. Sheehan also identified column 8, line 41 where Yasumi’s
`
`specification expressly states that “the fixed handle 26, the movable handle 37, and
`
`the setting piece 32 are coupled together.”1 Id. at 31:10-19.
`
`Response to Observation 6: Boston’s description of Mr. Sheehan’s testimony is
`
`incomplete and takes Mr. Sheehan’s testimony out of context. In the course of
`
`explaining how the movable handle 37 and setting piece 32 interact, Mr. Sheehan
`
`testified that “32 is shown to be a relatively thin plate . . . [s]o they would kind of
`
`flex. I’d expect them to flex a little bit to allow for any movement. But do they
`
`touch each other? I would say the proper answer is yes.” Ex. 2052 at 32:22-33:16.
`
`Edwards disagrees with Boston’s observation that this “testimony is relevant to
`
`whether there is sufficient disclosure in Yasumi to show how the device of Figure
`
`8 works and whether it could be used to crimp a stent.”
`
`
`1 Edwards objects to Boston’s Observations 5-13 because Boston improperly
`argues that Mr. Sheehan’s testimony is “relevant to whether there is sufficient
`disclosure in Yasumi to show how the device of Figure 8 works.” The Federal
`Circuit, however, has consistently held that enablement of a prior art reference is
`irrelevant to obviousness. See e.g. ABT Systems, LLC v. Emerson Elec. Co., 115
`U.S.P.Q.2d , 2015 WL 4924160, *8 n.2 (Fed. Cir. 2015). Rather than filing a
`motion to exclude, Petitioner understands that the Board will accord Observations
`5-13 with the appropriate weight.
`
`3
`
`

`

`IPR2017-00444
`Edwards v. Boston Scientific
`
`Response to Observation 7: Mr. Sheehan testified, consistent with his
`
`declarations, that Yasumi discloses that the movable handle 37 does not move
`
`independently of the setting piece 32 before the setting piece 32 hits the adjust cam
`
`because the pins run through everything. Ex. 2052 at 38:8-18; Ex. 1105 (Sheehan
`
`Decl.) at ¶¶102-104; Ex. 1127 (Sheehan Supp. Decl.) at ¶23.
`
`Response to Observation 8: Mr. Sheehan testified, consistent with his
`
`declarations, that when the movable handle 37 and the setting piece 32 are turning
`
`together, the pins 45 also rotate (“Everybody rotates.”). Ex. 2052 at 40:5-15; Ex.
`
`1105 (Sheehan Decl.) at ¶¶102-104; Ex. 1127 (Sheehan Supp. Decl.) at ¶23.
`
`Response to Observations 9A-C: Boston’s observation 9A is irrelevant given
`
`that Mr. Sheehan voluntarily acknowledged on his own that he misspoke during his
`
`earlier testimony and then promptly corrected his testimony as the questioning
`
`continued in real-time. Consistent with observations 9B and 9C and his
`
`declarations, Mr. Sheehan testified that before the setting piece 32 hits the adjust
`
`cam, the movable pieces rotate with the other components but the aperture does not
`
`necessarily change in size. Ex. 2052 at 43:11-44:18, 45:18-46:11; Ex. 1105
`
`(Sheehan Decl.) at ¶¶102-104; Ex. 1127 (Sheehan Supp. Decl.) at ¶23.
`
`Response to Observation 10: Boston’s description of Mr. Sheehan’s testimony is
`
`inaccurate and vague in its reference to “certain operation.” The phrase “certain
`
`4
`
`

`

`IPR2017-00444
`Edwards v. Boston Scientific
`
`operation” does not appear in the cited testimony, and Boston does not explain
`
`what it means by the phrase “certain operation.”
`
`Response to Observation 11: Edwards does not dispute that Mr. Sheehan
`
`testified, consistent with his declarations, that the movable pieces move together
`
`with the movable handle 37 and setting piece 32 until the setting piece 32 hits the
`
`adjust cam. Ex. 2052 at 45:18-25; Ex. 1105 (Sheehan Decl.) at ¶¶102-104; Ex.
`
`1127 (Sheehan Supp. Decl.) at ¶23. Edwards also does not dispute that Mr.
`
`Sheehan testified that the pins 45 become “fixed” once the setting piece 32 hits the
`
`adjust cam. Id. at 46:1-11.
`
`Response to Observation 12: Boston’s description of Mr. Sheehan’s testimony is
`
`incomplete. Boston crops a single phrase from a much longer, and more
`
`comprehensive, response. To understand Mr. Sheehan’s testimony and its
`
`relevance, the full response must be read. Ex. 2052 at 45:18-46:11.
`
`Response to Observation 13: Boston’s description of Mr. Sheehan’s testimony is
`
`incomplete. Boston cites a small portion of a much longer line of questions and
`
`answers. To understand Mr. Sheehan’s testimony and its relevance, the full set of
`
`questions and answers must be read. Ex. 2052 at 58:11-61:9. Edwards disagrees
`
`with Boston’s observation that this testimony is relevant to “how the pins 45 ‘are
`
`fixed’ in Figure 8 of Yasumi and whether there is sufficient disclosure in Yasumi
`
`to show how the device of Figure 8 works.”
`
`5
`
`

`

`IPR2017-00444
`Edwards v. Boston Scientific
`
`Response to Observation 14: Boston’s description of Mr. Sheehan’s testimony is
`
`incomplete. Mr. Sheehan testified:
`
`Q. Disc 42 can turn independently of side plate 27-2, correct?
`
`A. Can turn independently of it. At times, yes, it can. Turns within it, sure.
`
`But it’s still connected to it.
`
`Ex. 2052 at 63:15-19.
`
`Response to Observation 15: Boston’s description of Mr. Sheehan’s testimony is
`
`incomplete. Boston cites a small portion of a much longer line of questions and
`
`answers. To understand Mr. Sheehan’s testimony and its relevance, the full set of
`
`questions and answers must be read. Ex. 2052 at 70:2-71:25.
`
`Response to Observation 16: Boston’s description of Mr. Sheehan’s testimony is
`
`incomplete. Edwards does not dispute that Mr. Sheehan testified there are no
`
`“distinct connection locations” between the support discs and the side plates, as the
`
`term “distinct connection locations” is used in the ’560 patent. Ex. 2052 at 76:21-
`
`77:3. However, Mr. Sheehan also testified that the support discs are connected to
`
`the side plates. For example, Mr. Sheehan testified:
`
`Q. And you believe that support disc 41 is somehow connected to sideplate
`
`27-1?
`
`A. I would take the word ‘somehow’ out. Yes, of course its connected to it.
`
`It’s screwed down to it. It’s clamped to it. It’s urged against it.
`
`6
`
`

`

`IPR2017-00444
`Edwards v. Boston Scientific
`
`Ex. 2052 at 68:22-69:1. Edwards disagrees with Boston’s observation that this
`
`“testimony is relevant to whether the element of ‘distinct connection locations’ is
`
`met.”
`
`Response to Observation 17: Boston’s description of Mr. Sheehan’s testimony is
`
`inaccurate and misleading. First, in the cited testimony, Mr. Sheehan is discussing
`
`small “d” in Figure 3, not big “D” in Figure 8. Ex. 2052 at 82:17-20. Second,
`
`Boston cites a small portion of a much longer line of questions and answers. To
`
`understand the relevance of Mr. Sheehan’s testimony, the full set of questions and
`
`answers must be read. Ex. 2052 at 82:8-84:12. For example, Mr. Sheehan testified
`
`that the movement of the dies has “an inward component and an outward
`
`component.” Id. at 83:20-21.
`
`Response to Observation 18: Boston’s description of Mr. Sheehan’s testimony
`
`misstates the testimony. Mr. Sheehan testified that some of the references in the
`
`list were cited by the Examiner, not by the applicant in an IDS. Ex. 2052 at 94:13-
`
`23. Mr. Sheehan also testified that he did not know if any of the patent
`
`applications were cited before September 1999 because he did not have all of the
`
`documents in front of him. Ex. 2052 at 95:11-16. Edwards disagrees with
`
`Boston’s observation that this “testimony is relevant to whether there was a long-
`
`felt need and failure of others in uniform stent crimping.”
`
`7
`
`

`

`IPR2017-00444
`Edwards v. Boston Scientific
`
`Response to Observation 19: Boston’s description of Mr. Sheehan’s testimony is
`
`inaccurate and misleading. Mr. Sheehan testified that he used Edwards’ proposed
`
`Phillips claim constructions from the district court litigation for analyzing whether
`
`Edwards’ crimpers infringe any of the instituted claims. Ex. 2052 at 99:9-22; Ex.
`
`1127 (Sheehan Supp. Decl.) at ¶¶84-85.
`
`Response to Observation 20: Boston’s description of Mr. Sheehan’s testimony is
`
`inaccurate and misleading. Mr. Sheehan did not testify, as Boston contends, that
`
`“each of Petitioner’s products is commercially successful.” Instead, Mr. Sheehan
`
`testified that he had no problem characterizing Edwards’ Sapien heart valves as
`
`“commercially successful.” Ex. 2052 at 112:21-113:6.
`
`Response to Observation 21: Boston’s observation is attorney argument and
`
`irrelevant. Whether the existence of an “alternative design” precludes a finding of
`
`“nexus” between the claimed invention and the commercial success is legal
`
`question. Petitioner understands the Board will accord Boston’s attorney argument
`
`with the appropriate weight.
`
`Response to Observation 22: Boston’s description of Mr. Sheehan’s testimony is
`
`incomplete, misleading and unhelpful because it takes Mr. Sheehan’s testimony
`
`out of context and the underlying question called for Mr. Sheehan to speculate.
`
`Boston asked “why didn’t any of these patents cite Yasumi as a suitable device for
`
`crimping a stent?” Ex. 2052 at 98:23-25. Mr. Sheehan made clear that his
`
`8
`
`

`

`IPR2017-00444
`Edwards v. Boston Scientific
`
`response was speculative: “I mean, you’re asking me what was in the mind of a
`
`whole bunch of lawyers, and I have no idea what was in their mind.” Id. at 99:1-3.
`
`Response to Observation 23: Boston’s observation is improper attorney
`
`argument and irrelevant. Edwards understands the Board will accord Boston’s
`
`attorney argument with the appropriate weight. Regardless, Mr. Sheehan has made
`
`consistent statements regarding the state of the art in uniform stent crimping as of
`
`September 1999. See e.g., Ex. 1105 (Sheehan Decl.) at ¶¶81-92 (describing the
`
`field of endeavor); Ex. 1127 (Sheehan Supp. Decl.) at ¶¶54-77 (describing state of
`
`art).
`
`Dated: February 23, 2018
`
`
`
`
`
`Respectfully Submitted,
`
`By: /Craig S. Summers/
`Craig S. Summers (Reg. No. 31,430)
`Brenton R. Babcock (Reg. No. 39,592)
`Christy G. Lea (Reg. No. 51,754)
`Joshua Stowell (Reg. No. 64,096)
`Cheryl T. Burgess (Reg No. 55,030)
`Customer No. 20,995
`
`Attorneys for Petitioner
`EDWARDS LIFESCIENCES CORP.
`
`
`
`9
`
`

`

`
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that a true and correct copy of PETITIONER’S
`
`RESPONSE TO PATENT OWNER’S MOTION FOR OBSERVATIONS ON
`
`CROSS-EXAMINATION is being served on February 23, 2018, via electronic
`
`mail pursuant to 37 C.F.R. § 42.6(e) and with the consent of Patent Owner’s
`
`counsel, to counsel for Patent Owner’s at the addresses below:
`
`
`
`Nicholas M. Nyemah
`Nicholas.Nyemah@aporter.com
`ARNOLD & PORTER LLP
`601 Massachusetts Avenue, NW
`Washington, DC 20001
`
`
`Wallace Wu
`Wallace.Wu@aporter.com
`Jennifer A. Sklenar
`Jennifer.Sklenar@aporter.com
`xEDW_BSC_IPR201700444@aporter.com
`ARNOLD & PORTER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`
`
`
`Dated: February 23, 2018
`
`
`
`
`
`By: /Craig S. Summers/
`Craig S. Summers (Reg. No. 31,430)
`Brenton R. Babcock (Reg. No. 39,592)
`Christy G. Lea (Reg. No. 51,754)
`Joshua Stowell (Reg. No. 64,096)
`Cheryl T. Burgess (Reg No. 55,030)
`Customer No. 20,995
`
`Attorneys for Petitioner
`EDWARDS LIFESCIENCES CORP.
`
`27592284
`
`1
`
`

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