UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP.,
`
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-00444
`Patent 6,915,560
`_______________
`
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and STACY B.
`MARGOLIES, Administrative Patent Judges.
`
`PATENT OWNER’S MOTION FOR
`OBSERVATIONS ON CROSS-EXAMINATION
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`1
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP.,
`
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-00444
`Patent 6,915,560
`_______________
`
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and STACY B.
`MARGOLIES, Administrative Patent Judges.
`
`PATENT OWNER’S MOTION FOR
`OBSERVATIONS ON CROSS-EXAMINATION
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`1
`
`
`
`Pursuant to the Case Management and Scheduling Order (Paper No. 10),
`
`Boston Scientific Scimed, Inc. (“Patent Owner”) hereby moves for consideration
`
`of the following observations on cross-examination testimony of Edwards
`
`Lifesciences Corporation’s (“Petitioner’s”) reply witness, Mr. Neil Sheehan. The
`
`transcript of his deposition on January 26, 2018 and his supplemental declaration
`
`have been filed as Exhibits 2052 and 1127, respectively.1 The challenged patent,
`
`U.S. Patent No. 6,915,560 (the ’560 patent), and the principal prior art reference,
`
`U.S. Patent No. 4,454,657 (“Yasumi”), have been filed as Exhibits 1101 and 1103,
`
`respectively.
`
`I.
`
`Observations Regarding Mr. Sheehan’s Expertise
`Observation #1.
`In Exhibit 2052, on page 9, line 17 through page 10, line
`
`25, Mr. Sheehan testified, with respect to paragraph 8 of his supplemental
`
`declaration, that he removed stents from the balloon catheter products about six
`
`years after the relevant time frame of the ’560 patent and that he did not crimp a
`
`stent on a balloon catheter. This testimony is relevant to whether Mr. Sheehan has
`
`the relevant experience. (See Paper No. 15 at 13-14.)
`
`1 Petitioner filed a corrected Exhibit 1127 on January 19, 2018 (which adds only an
`
`under-the-penalty-of-perjury statement at the end).
`
`2
`
`
`
`Observation #2.
`
`In Exhibit 2052, on page 14, line 4 through line 10, Mr.
`
`Sheehan testified, with respect to paragraph 9 of his supplemental declaration, that
`
`he did not crimp a stent on a balloon catheter. This testimony is relevant to
`
`whether Mr. Sheehan has the relevant experience. (See Paper No. 15 at 13-14.)
`
`II.
`
`Observations Regarding Disclosures Relating To Figure 8 Of Yasumi
`
`Observation #3.
`
`In Exhibit 2052, on page 20, line 2 through line 24, Mr.
`
`Sheehan testified, with respect to paragraph 18 of his supplemental declaration,
`
`that Figure 8 does not disclose a pin connector (so that it “can be crimped securely
`
`onto the wire”) and that only Figure 9 of Yasumi relates to a pin connector. (Ex.
`
`1127 at ¶ 18.) This testimony is relevant to whether Figure 8 of Yasumi is a stent
`
`crimper. (See Paper No. 15 at 30.)
`
`Observation #4.
`
`In Exhibit 2052, on page 27, line 20 through line 25, Mr.
`
`Sheehan testified, with respect to paragraph 19 of his supplemental declaration,
`
`that an “electric wire or the like” is the only example given in connection with
`
`Figure 8 of Yasumi. This testimony is relevant to whether Figure 8 of Yasumi is a
`
`stent crimper. (See Paper No. 15 at 30.)
`
`III.
`
`Observations Regarding How Figure 8 Of Yasumi Operates
`
`Observation #5.
`
`In Exhibit 2052, on page 30, line 23 through page 32,
`
`line 16, Mr. Sheehan cannot point to, with respect to the second sentence of
`
`paragraph 23 of his supplemental declaration, any disclosure at column 8, line 1
`
`3
`
`
`
`through 41 of Yasumi showing how the movable handle 37 is coupled to the
`
`setting piece 32. (Ex. 1127 at ¶ 23 (“The …movable handle 37 (purple) and setting
`
`piece 32 (blue) are coupled together in the manner described in the specification,
`
`id., at 8:1-41….”).) This testimony is relevant to whether there is sufficient
`
`disclosure in Yasumi to show how the device of Figure 8 works. (See Exhibit
`
`2016 [Solar Decl.] at ¶¶ 40, 68; Paper No. 15 at 31, 33.)
`
`Observation #6.
`
`In Exhibit 2052, on page 33, line 13 through line 16, Mr.
`
`Sheehan testified, with respect to paragraph 23 of his supplemental declaration,
`
`that the setting piece 32 “would kind of flex” and “flex a little bit to allow for any
`
`movement.” 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. (See Exhibit 2016 [Solar Decl.] at ¶¶ 40, 68; Paper No. 15 at 30,
`
`31.)
`
`Observation #7.
`
`In Exhibit 2052, on page 38, line 15 through line 18, Mr.
`
`Sheehan testified, with respect to paragraph 23 of his supplemental declaration,
`
`that the movable handle 37 can’t move independently of the setting piece 32 before
`
`the setting piece 32 hits the adjust cam because “the pins run through everything”
`
`and “they are all held together.” This testimony is relevant to how the pins 45 “are
`
`fixed” in Figure 8 of Yasumi and whether there is sufficient disclosure in Yasumi
`
`4
`
`
`
`to show how the device of Figure 8 works. (See Exhibit 1103 at 8:50; Exhibit
`
`2016 [Solar Decl.] at ¶¶ 40, 68; Paper No. 15 at 31, 33.)
`
`Observation #8.
`
`In Exhibit 2052, on page 40, line 5 through line 7, Mr.
`
`Sheehan testified, with respect to paragraph 23 of his supplemental declaration,
`
`that when the movable handle 37 and the setting piece 32 are turning together, the
`
`pins 45 move also and “everybody rotates.” 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. (See Exhibit 1103 at 8:50;
`
`Exhibit 2016 [Solar Decl.] at ¶¶ 40, 68; Paper No. 15 at 31, 33.)
`
`Observation #9A. In Exhibit 2052, on page 40, line 11 through page 41,
`
`line 18, Mr. Sheehan testified, with respect to paragraph 23 of his supplemental
`
`declaration, that when the movable handle 37 and the setting piece 32 are moving
`
`together before the setting piece 32 hits the adjust cam, the movable pieces also
`
`move and the aperture gets “smaller” and “pre-size[s].” This testimony is relevant
`
`to whether there is sufficient disclosure in Yasumi to show how the device of
`
`Figure 8 works. (See Exhibit 2016 [Solar Decl.] at ¶¶ 40, 68; Paper No. 15 at 31,
`
`33.)
`
`Observation #9B. In Exhibit 2052, on page 43, line 11 through page 44,
`
`line 2, Mr. Sheehan testified, with respect to paragraph 23 of his supplemental
`
`declaration, that when the movable handle 37 and the setting piece 32 are moving
`
`5
`
`
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`together before the setting piece 32 hits the adjust cam, the movable pieces “don’t
`
`necessarily move until you hit the setting piece” and the aperture does not change.
`
`This testimony is relevant to whether there is sufficient disclosure in Yasumi to
`
`show how the device of Figure 8 works. (See Exhibit 2016 [Solar Decl.] at ¶¶ 40,
`
`68; Paper No. 15 at 31, 33.)
`
`Observation #9C. In Exhibit 2052, on page 44, line 6 through line 15, Mr.
`
`Sheehan testified, with respect to paragraph 23 of his supplemental declaration,
`
`that when the movable handle 37 and the setting piece 32 are moving together
`
`before the setting piece 32 hits the adjust cam, the movable pieces move together
`
`with everything else, but the aperture does not change. This testimony is relevant
`
`to whether there is sufficient disclosure in Yasumi to show how the device of
`
`Figure 8 works. (See Exhibit 2016 [Solar Decl.] at ¶¶ 40, 68; Paper No. 15 at 31,
`
`33.)
`
`Observation #10. In Exhibit 2052, on page 45, line 14 through line 16, Mr.
`
`Sheehan testified, with respect to paragraph 23 of his supplemental declaration,
`
`that Figure 3 of Yasumi does not describe certain operation of Figure 8 of Yasumi.
`
`This testimony is relevant to whether there is sufficient disclosure in Yasumi to
`
`show how the device of Figure 8 works. (See Exhibit 2016 [Solar Decl.] at ¶¶ 40,
`
`68; Paper No. 15 at 31, 33.)
`
`6
`
`
`
`Observation #11. In Exhibit 2052, on page 45, line 18 through line 25, Mr.
`
`Sheehan testified, with respect to paragraph 23 of his supplemental declaration,
`
`that when the movable handle 37 and the setting piece 32 are moving together
`
`before the setting piece 32 hits the adjust cam, the movable pieces rotate with
`
`“everybody.” 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. (See Exhibit 1103 at 8:50; Exhibit 2016 [Solar Decl.] at
`
`¶¶ 40, 68; Paper No. 15 at 31, 33.)
`
`Observation #12. In Exhibit 2052, on page 46, line 8 through line 9, Mr.
`
`Sheehan testified, with respect to paragraph 23 of his supplemental declaration,
`
`that when the movable handle 37 and the setting piece 32 are moving separately
`
`after the setting piece 32 hits the adjust cam, “the blue part is held still, which
`
`holds the pins.” This testimony is relevant to how the pins 45 “move in the
`
`elongated holes 23-1 to 23-6” in Figure 8 of Yasumi and whether there is sufficient
`
`disclosure in Yasumi to show how the device of Figure 8 works. (See Exhibit
`
`1103 at 8:52-53; Exhibit 2016 [Solar Decl.] at ¶¶ 40, 68; Paper No. 15 at 31, 33.)
`
`Observation #13. In Exhibit 2052, on page 58, line 14 through page 59,
`
`line 22, Mr. Sheehan testified, with respect to paragraph 23 of his supplemental
`
`declaration, that in Figure 3 of Yasumi, the pins are press-fit and, in Figure 8, the
`
`components colored blue on page 9 of his supplemental declaration perform the
`
`7
`
`
`
`same function as the guide base of Figure 3 but without pins “sticking out of it.”
`
`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. (See Exhibit 1103 at 8:50; Exhibit 2016 [Solar Decl.] at ¶¶ 40, 68;
`
`Paper No. 15 at 31, 33.)
`
`IV.
`
`Observations Regarding The “Operatively Engaged” Element
`
`Observation #14. In Exhibit 2052, on page 63, line 17 through line 19, Mr.
`
`Sheehan testified that disc 42 can turn independently of side plate 27-2. This
`
`testimony is relevant to whether support disc 42 is operatively engaged to side
`
`plate 27-2. (See Paper No. 15 at 26-27.)
`
`Observation #15. In Exhibit 2052, on page 70, line 2 through line 14, Mr.
`
`Sheehan testified that (1) support disc 41 is larger in diameter than the hole in side
`
`plate 27-1, (2) there are no discrete pinholes on side plate 27-1, and (3) support
`
`disc 41 can turn independently of side plate 27-1. This testimony is relevant to
`
`whether support disc 41 is operatively engaged to side plate 27-1. (See Paper No.
`
`15 at 26-27.)
`
`V.
`
`Observations Regarding The “Distinct Connection Locations” Element
`
`Observation #16. In Exhibit 2052, on page 76, line 21 through page 77,
`
`line 3, Mr. Sheehan testified that there is no factual dispute that there are no
`
`distinct connection locations between support disc 41 and side plate 27-1 or
`
`8
`
`
`
`between support disc 42 and side plate 27-2. This testimony is relevant to whether
`
`the element of “distinct connection locations” is met. (See Paper No. 15 at 26-27.)
`
`VI.
`
`Observations Regarding Moving “Inward” And “Outward” Elements
`
`Observation #17. In Exhibit 2052, on page 83, line 4 through line 9 and
`
`line 22 through line 24, Mr. Sheehan testified that the “D” direction of the movable
`
`pieces in Figure 8 of Yasumi is at an angle to the guide base and has a “lateral
`
`component.” This testimony is relevant to whether the elements of moving
`
`“inward” and “outward” are met and whether the apparent mechanism of action of
`
`Figure 8 of Yasumi would impose a shear force on a stent. (See Paper No. 15 at
`
`27-28, 31.)
`
`VII.
`
`Observations Regarding Secondary Factors
`
`Observation #18. In Exhibit 2052, on page 94, line 13 through page 95,
`
`line 16, Mr. Sheehan testified, with respect to the table in paragraph 76 of his
`
`supplemental declaration, that the patents and patent applications he listed in the
`
`table only cited Yasumi in Information Disclosure Statements of these patents or
`
`patent applications after the priority date of the ’560 patent (September 1999).
`
`This testimony is relevant to whether there was a long-felt need and failure of
`
`others in uniform stent crimping. (See Exhibit 2016 [Solar Decl.] at ¶ 83; Paper
`
`No. 15 at 36-37.)
`
`9
`
`
`
`Observation #19. In Exhibit 2052, on page 99, line 9 through line 22, Mr.
`
`Sheehan testified, with respect to the table in paragraph 85 of his supplemental
`
`declaration, that the claim construction positions he used were Petitioner’s
`
`constructions, not his constructions, and that he performed no analysis of
`
`Petitioner’s constructions. This testimony is relevant to whether Mr. Sheehan used
`
`the proper claim constructions to dispute Dr. Solar’s analysis of Petitioner’s
`
`products in view of the ’560 patent. (See Exhibit 2016 [Solar Decl.] at Appendix
`
`C.)
`
`Observation #20. In Exhibit 2052, on page 112, line 21 through page 113,
`
`line 6, Mr. Sheehan testified that he does not dispute that each of Petitioner’s
`
`products is commercially successful. This testimony is relevant to whether there
`
`was commercial success associated with Petitioner’s products. (See Exhibit 2016
`
`[Solar Decl.] at ¶ 76.)
`
`Observation #21. In Exhibit 2052, on page 115, line 20 through line 24,
`
`Mr. Sheehan testified that the presence of alternative design does not preclude a
`
`finding of a nexus between the claimed invention and the commercial success of a
`
`product. This testimony is relevant to whether there was nexus between the
`
`claimed invention and the commercial success of Petitioner’s products. (See
`
`Exhibit 2016 [Solar Decl.] at ¶ 77.)
`
`VIII.
`
`Observations Regarding Figure 8 Of Yasumi As Stent Crimper And
`Motivation To Modify It To Crimp A Stent
`
`10
`
`
`
`Observation #22. In Exhibit 2052, on page 98, line 23 through page 99,
`
`line 3, Mr. Sheehan testified, with respect to the table in paragraph 76 of his
`
`supplemental declaration, that the applicants in the patents and patent applications
`
`he cited in the table “had no reason” to cite Yasumi as a suitable device for
`
`crimping a stent. This testimony is relevant to whether a skilled artisan would
`
`have considered Figure 8 of Yasumi a stent crimper or would have been motivated
`
`to modify it to crimp a stent. (See Paper No. 15 at 29-30.)
`
`IX.
`
`Observations Regarding Mr. Sheehan’s Earlier Declaration
`
`Observation #23. In Exhibit 2052, on page 116, line 8 through line 12, Mr.
`
`Sheehan testified that he stands by everything he said in his earlier declaration (Ex.
`
`1105). This testimony is relevant to whether Mr. Sheehan has changed his earlier
`
`statements regarding the state of the art in uniform stent crimping as of September
`
`1999, the priority date of the ’560 patent. (See Paper No. 15 at 36-37.)
`
`Dated: February 9, 2018
`
`Respectfully submitted,
`
`/s/ Wallace Wu
`Wallace Wu (Reg. No. 45,380)
`Jennifer A. Sklenar (Reg. No. 40,205)
`ARNOLD & PORTER KAYE
`SCHOLER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel: (213) 243-4000
`Fax: (213) 243-4199
`
`Nicholas M. Nyemah (Reg. No. 67,788)
`
`11
`
`
`
`ARNOLD & PORTER KAYE
`SCHOLER LLP
`601 Massachusetts Avenue, NW
`Washington, DC 20001
`Telephone: (202) 942-5000
`Fax: (202) 942-5999
`
`Attorneys for Patent Owner Boston
`Scientific Scimed, Inc
`
`12
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Patent Owner’s
`Observations on Cross-Examination was served on February 9, 2018 to the
`following Counsel for Petitioner via e-mail:
`
`Craig S. Summers
`Brenton R. Babcock
`Christy G. Lea
`Cheryl T. Burgess
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`2css@knobbe.com
`2brb@knobbe.com
`2cgl@knobbe.com
`2ctb@knobbe.com
`BoxEdwards@knobbe.com
`
`Attorneys for Petitioner Edwards Lifesciences Corp.
`
`/s/ Wallace Wu
`Wallace Wu (Reg. No. 45,380)
`ARNOLD & PORTER KAYE
`SCHOLER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel: (213) 243-4000
`Fax: (213) 243-4199
`
`-13-
`
`
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