`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS
`LIFESCIENCES LLC, AND EDWARDS LIFESCIENCES AG
`
`Petitioners,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`______________
`
`Case IPR2017-00060
`Patent 8,992,608
`______________
`
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and
`ROBERT L. KINDER, 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
`
`
`
`Pursuant to the Scheduling Order, Patent Owner Boston Scientific
`
`Scimed, Inc. (“Patent Owner”) hereby respectfully moves for consideration of the
`
`following observations on cross-examination.
`
`I.
`
`Observations On Cross-Examination Of Petitioner’s Declarant
`Larry Wood
`
`Observation #1. In Exhibit 2096, on page 8 line 25 through page 9 line 23,
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`Mr. Wood testified that he does not have a medical degree or an engineering
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`degree and that he is not an interventional cardiologist or a cardiac or vascular
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`surgeon. This testimony is relevant to establish that Mr. Wood is not a person of
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`ordinary skill in the art (“POSITA”) under either party’s proposed definition of
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`ordinary skill. (See Paper 1 at 45-46; Paper 6 at 7.)
`
`Observation #2. In Exhibit 2096, on page 10 lines 3 through 8, Mr. Wood
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`testified that he is not offering an opinion as to Patent Owner’s efforts to match up
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`the claim elements of the ‘608 patent to the SAPIEN 3 device. This testimony is
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`relevant to whether there is a nexus between the claimed invention and the
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`commercial success of the SAPIEN 3. (See Paper 22 at 50-58; Paper 34 at 19-23;
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`Ex. 1046 at ¶¶ 38-45.)
`
`Observation #3. In Exhibit 2096, on page 10 line 12 through page 11 line 6,
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`Mr. Wood testified that a number of papers, including the PARTNER II S3i study
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`sponsored by Petitioner, have determined an association between paravalvular
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`leakage (“PVL”) and mortality. This testimony is relevant to whether there was a
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`
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`long-felt need for a solution to PVL, such as that disclosed in the ‘608 patent. (See
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`Paper 22 at 63-64; Paper 34 at 26; Ex. 1046 at ¶¶ 29-33.)
`
`Observation #4. In Exhibit 2096, on page 12 line 10 through page 13 line 6,
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`Mr. Wood testified that he was aware of findings by clinicians that moderate to
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`severe PVL was an independent predictor of mortality at one year and two years.
`
`This testimony is relevant to whether there was a long-felt need for a solution to
`
`PVL, such as that disclosed in the ‘608 patent. (See Paper 22 at 63-64; Paper 34 at
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`26; Ex. 1046 at ¶¶ 29-33.)
`
`Observation #5. In Exhibit 2096, on page 54 line 7 through page 56 line 9,
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`Mr. Wood testified that the finding that “the presence of paravalvular or total aortic
`
`regurgitation, mild, moderate or severe versus none or trace, after TAVR was
`
`associated with increased late mortality” in Exhibit 2097—an article discussing
`
`results of the PARTNER trial sponsored by Petitioner—was statistically
`
`significant. This testimony is relevant to whether there was a long-felt need for a
`
`solution to PVL, such as that disclosed in the ‘608 patent. (See Paper 22 at 63-64;
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`Paper 34 at 26; Ex. 1046 at ¶¶ 29-33.)
`
`Observation #6. In Exhibit 2096, on page 16 lines 14 through 19, Mr. Wood
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`testified that he does not think anybody believes that PVL is good for you and that
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`“[e]veryone would rather have less of it than more of it.” This testimony is
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`relevant to whether there was a long-felt need for a solution to PVL, such as that
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`-2-
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`
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`disclosed in the ‘608 patent. (See Paper 22 at 63-64; Paper 34 at 26; Ex. 1046 at
`
`¶¶ 29-33.)
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`Observation #7. In Exhibit 2096, on page 18 lines 9 through 15, Mr. Wood
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`testified that the SAPIEN XT and the SAPIEN 3 were offered in the same sizes
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`and, on page 30 lines 14 through 15, Mr. Wood testified that the “SAPIEN 3 has
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`less paravalvular leakage than XT at some level.” This testimony is relevant to
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`whether the problem of PVL had been solved before the ‘608 patent and, in
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`particular, whether proper valve sizing was a complete solution to PVL. (See
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`Ex. 1046 ¶ 29.)
`
`Observation #8. In Exhibit 2096, on page 22 line 25 through page 23
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`line 10, Mr. Wood testified that “[t]here are certain risks to oversizing” and that
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`“[i]f you oversize too much, you can actually tear the tissue or rupture the
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`annulus.” This testimony is relevant to whether the problem of PVL had been
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`solved before the ‘608 patent and, in particular, whether oversizing was a complete
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`solution to PVL. (See Ex. 1046 ¶ 30.)
`
`Observation #9. In Exhibit 2096, on page 24 line 13 through page 25
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`line 22, Mr. Wood testified that the author of Exhibit 2059, which Mr. Wood cites
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`in his declaration (Ex. 1046 ¶ 30), believes that “you don’t have to oversize as
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`aggressively with the Sapien 3 to achieve paravalvular leak reduction” and “if you
`
`do less oversizing, could reduce your risk of annular rupture.” This testimony is
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`-3-
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`
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`relevant to whether the problem of PVL had been solved before the ‘608 patent
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`and, in particular, whether oversizing was a complete solution to PVL.
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`(See Ex. 1046 ¶ 30.)
`
`Observation #10. In Exhibit 2096, on page 33 line 14 through page 36
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`line 15, Mr. Wood testified that, in the 2006 time frame, “the most challenging
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`thing about paravalvular leak was we were still trying to solve something we didn’t
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`fully understand” and “we had this PV leak problem, but we didn’t really
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`understand the source of the problem because we didn’t understand the
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`fundamental environment we were working in.” This testimony is relevant to
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`whether the problem of PVL had been solved before the ‘608 patent.
`
`(See Ex. 1046 ¶¶ 18-28.)
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`Observation #11. In Exhibit 2096, on page 36 lines 16 through 24,
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`Mr. Wood testified that “a primary consideration” in Petitioner’s decision not to
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`add an outer skirt to the first two generations of its TAVR valve, the SAPIEN and
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`SAPIEN XT, was “concern about vascular complications due to an increase in
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`crimp profile” and that, in the SAPIEN 3, Petitioner was able to add a skirt without
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`compromising crimp profile. This testimony is relevant to whether Petitioner had
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`independently conceived of the invention of the ‘608 patent, which shows how the
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`fabric seal has a greater impact on profile in the deployed configuration than it
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`does in the delivery configuration. (See Ex. 1046 ¶ 25; Ex. 1001 FIGS. 32, 33.)
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`-4-
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`
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`Observation #12. In Exhibit 2096, on page 38 lines 2 through 15, Mr. Wood
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`testified that Petitioner never conducted live human studies with the valves from its
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`Patriot project, never filed for approval to start a clinical trial of the valves from
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`the Patriot project, and never submitted data in support of commercial approval for
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`such valves. This testimony is relevant to whether Petitioner had independently
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`conceived of the invention of the ‘608 patent. (See Ex. 1046 ¶¶ 22, 23.)
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`Observation #13. In Exhibit 2096, on page 38 line 25 through page 39
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`line 6, Mr. Wood testified that the cloth on the crown valve from Petitioner’s
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`Patriot project was “not puffy” and was “pretty much sewn everywhere.” This
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`testimony is relevant to whether Petitioner had independently conceived of the
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`invention of the ‘608 patent and, in particular, whether the crown valve would
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`form “flaps” and “pockets” as claimed in the ‘608 patent. (See Ex. 1046 ¶¶ 22, 23;
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`Ex. 1001 col. 22:21-46.)
`
`Observation #14. In Exhibit 2096, on page 39 line 7 through page 40
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`line 24, Mr. Wood testified that he did not have any reason to believe that
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`Exhibit 2063 was not created in connection with Petitioner’s business or
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`maintained in Petitioner’s files. This testimony is relevant to whether
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`Exhibit 2063, in which the designers of the SAPIEN 3 state that
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`invention of the ‘608 patent yielded unexpected results. (See Ex. 1046 ¶ 37.)
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`is evidence that the
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`-5-
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`
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`Observation #15. In Exhibit 2096, on page 40 line 25 through page 42
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`line 22, Mr. Wood testified that “TAVR doctors are well aware of the outer skirt
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`on Sapien 3,” “some doctors certainly attribute some of the improved PVL data for
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`Sapien 3 to the skirt,” and that there is “a common belief that the skirt contributes
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`to the reduction of paravalvular leak.” This testimony is relevant to whether the
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`SAPIEN 3 received industry praise directed specifically to its fabric seal.
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`(See Ex. 1046 ¶ 36.)
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`Observation #16. In Exhibit 2096, on page 48 lines 18 through 25,
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`Mr. Wood testified that some of the success and popularity of Petitioner’s
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`SAPIEN 3 valve is due to reductions in PVL. This testimony is relevant to
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`whether the SAPIEN 3 enjoyed commercial success as a result of its fabric seal.
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`(See Ex. 1046 at ¶¶ 38-45.)
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`Observation #17. In Exhibit 2096, on page 49 lines 10 through 18,
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`Mr. Wood testified that all of the features of Petitioner’s SAPIEN 3 product,
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`including the outer skirt, contributed to its success. This testimony is relevant to
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`whether the SAPIEN 3 enjoyed commercial success as a result of its fabric seal.
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`(See Ex. 1046 at ¶¶ 38-45.)
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`Observation #18. In Exhibit 2096, on page 49 line 24 through page 52
`
`line 23, Mr. Wood testified that Exhibit 2099 showed
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`-6-
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`
`
`(Ex. 2099 at 26.) This testimony is relevant to whether the SAPIEN 3 enjoyed
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`commercial success. (See Ex. 1046 at ¶¶ 38-45.)
`
`Observation #19. In Exhibit 2096, on page 52 line 24 through page 53
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`line 25, Mr. Wood explained the statement in Exhibit 2099 that
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`relevant to whether the SAPIEN 3 enjoyed commercial success. (See Ex. 1046 at
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`This testimony is
`
`¶¶ 38-45.)
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`-7-
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`
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`II. Observations On Cross-Examination Of Petitioner’s Declarant
`Nigel Buller, M.D.
`
`Observation #20. In Exhibit 2094, on page 52 lines 1 through 5, Dr. Buller
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`testified that he did not consider any secondary considerations of non-obviousness
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`regarding the ‘608 patent other than copying. This testimony is relevant to
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`determining the probative value of Dr. Buller’s opinions regarding obviousness of
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`the ‘608 patent. (See generally Exs. 1007, 1045.)
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`Observation #21. In Exhibit 2094, on page 11 lines 6 through 18, Dr. Buller
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`testified that he has only implanted two stent grafts in the aorta during his entire
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`career, neither of which was an abdominal aortic aneurysm (“AAA”) stent graft as
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`found in the prior art at issue here. This testimony is relevant to determining the
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`probative value of Dr. Buller’s opinions regarding obviousness of the ‘608 patent
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`relative to those of Drs. Manganaro and Brecker. (See generally Exs. 1007, 1045.)
`
`Observation #22. In Exhibit 2094, on page 16 lines 12 through 20,
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`Dr. Buller testified that he has never performed a surgical cut down of the aorta,
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`which results in direct observation of the aorta’s anatomy. (Id.) This testimony is
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`relevant to determining the probative value of Dr. Buller’s opinions regarding
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`obviousness of the ‘608 patent. (See generally Exs. 1007, 1045.)
`
`Observation #23. In Exhibit 2094, on page 19 line 16 through page 21
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`line 21, Dr. Buller testified that the term “stability” in WO 03/047468 (Ex. 1004,
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`“Spenser”) refers to reducing migration and that this term means different things in
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`-8-
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`
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`different contexts of Spenser. This testimony is relevant to whether a POSITA
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`would have combined Spenser’s valve with the AAA stent grafts’ skirts and, in
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`particular, to disprove Petitioner’s contention (Paper 34 at 4) and Dr. Buller’s
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`opinion (Ex. 1045 ¶ 28) that Spenser’s reference to “stability” refers to the valve’s
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`construction rather than valve migration.
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`Observation #24. In Exhibit 2094, on page 22 lines 10 through 24,
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`Dr. Buller testified that the seal in WO 05/102015 (Ex. 1059, “Bergheim”) is
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`tightly wrapped around the stent—i.e., it does not include excess material. This
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`testimony is relevant to whether a POSITA would have combined Spenser’s valve
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`with the AAA stent grafts’ skirts and, in particular, to disprove Petitioner’s
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`contention (Paper 34 at 4-5) and Dr. Buller’s opinion (Ex. 1045 ¶ 30) that
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`Bergheim demonstrates that excess material around a valve may improve stability
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`of the device and prevent migration.
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`Observation #25. In Exhibit 2094, on page 35 lines 1 through page 36
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`line 6, Dr. Buller testified that the ‘608 patent solved the problem of PVL
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`generally, not PVL in calcified diseased valves specifically. This testimony is
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`relevant to whether a POSITA would have combined Spenser’s valve with the
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`AAA stent grafts’ skirts and, in particular, to demonstrate Petitioner’s and Dr.
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`Buller’s misunderstanding of the ‘608 patent, which specifically teaches that it
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`solves the problem of PVL in “diseased aortic valve[s]” with “irregular” surfaces,
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`-9-
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`
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`such as those afflicted with calcification. (Ex. 1001 col. 12:19-27, col. 14:21-29,
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`FIGS. 13, 32-34.)
`
`Observation #26. In Exhibit 2094, on page 38 line 10 through page 39
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`line 8, Dr. Buller testified that a POSITA would want to design a transcatheter
`
`aortic valve replacement (“TAVR”) device that worked in a calcified environment.
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`This testimony is relevant to whether a POSITA would have combined Spenser’s
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`valve with the AAA stent grafts’ skirts and, in particular, to disprove Petitioner’s
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`contention (Paper 34 at 6-7) and Dr. Buller’s opinion (Ex. 1045 ¶ 40) that a
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`POSITA would not have considered aortic calcification when designing a PVL
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`solution.
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`Observation #27. In Exhibit 2094, on page 43 line 15 through page 44
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`line 24 and on page 45 line 24 through page 46 line 4, Dr. Buller did not dispute
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`Dr. Manganaro’s opinion (Ex. 2079 ¶¶ 68-72) that the nature of diseased aortic
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`annulus calcifications (where TAVR devices are implanted) is fundamentally
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`different than the nature of aortic calcifications (where stent grafts are implanted),
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`and admitted that he did not opine on this matter in his declarations. This
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`testimony is relevant to whether a POSITA would have combined Spenser’s valve
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`with the AAA stent grafts’ skirts and, in particular, to disprove Petitioner’s
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`contention (Paper 34 at 6-7, 13-17) and Dr. Buller’s opinion (Ex. 1045 ¶¶ 40-47)
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`
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`that AAA stent grafts were designed to seal leaks caused by calcifications like
`
`those found in the aortic annulus.
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`Observation #28. In Exhibit 2094, on page 42 lines 6 through 11, Dr. Buller
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`testified that the article published in 2005 by R.W. Jayalath et al. titled “Aortic
`
`Calcification (Ex. 1060, “Jayalath Article”) does not indicate whether aortic
`
`calcification is relevant to treating aortic aneurysms with stent grafts. This
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`testimony is relevant to whether a POSITA would have combined Spenser’s valve
`
`with the AAA stent grafts’ skirts and, in particular, to disprove Petitioner’s
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`contention (Paper 34 at 6-7) and Dr. Buller’s opinion (Ex. 1045 ¶¶ 46-47) that the
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`Jayalath Article is evidence that AAA stent grafts were designed to seal leaks
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`caused by calcifications like those found in the aortic annulus.
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`Observation #29. In Exhibit 2094, on page 41 line 23 through page 42
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`line 5, Dr. Buller testified that the Jayalath Article does not correlate aortic
`
`calcification with diseased aortic annulus calcification. This testimony is relevant
`
`to whether a POSITA would have combined Spenser’s valve with the AAA stent
`
`grafts’ skirts and, in particular, to disprove Petitioner’s contention (Paper 34 at 6-7)
`
`and Dr. Buller’s opinion (Ex. 1045 ¶¶ 46-47) that the Jayalath Article is evidence
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`that AAA stent grafts were designed to seal leaks caused by calcifications like
`
`those found in the aortic annulus.
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`
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`Observation #30. In Exhibit 2094, on page 52 lines 1 through 5, Dr. Buller
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`testified that participation in the Reaven and Sacks study cited in the Jayalath
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`Article (cited as evidence of the prominence of aortic calcifications) was limited to
`
`Hispanics with type 2 diabetes, which Dr. Buller admitted are not representative of
`
`all patients. This testimony is relevant to whether a POSITA would have
`
`combined Spenser’s valve with the AAA stent grafts’ skirts and, in particular, to
`
`disprove Petitioner’s contention (Paper 34 at 6-7) and Dr. Buller’s opinion
`
`(Ex. 1045 ¶¶ 46-47) that the Jayalath Article and Reaven and Sacks study are
`
`evidence that AAA stent grafts were designed to seal leaks caused by calcifications
`
`like those found in the aortic annulus.
`
`Observation #31. In Exhibit 2094, on page 62 line 17 through page 63
`
`line 7, Dr. Buller testified that he could not state that a TAVR device featuring an
`
`inner and outer skirt made of two pieces of the same material (Ex. 2095, Ex. A to
`
`Dr. Buller’s deposition) would not infringe the ‘608 patent. This testimony is
`
`relevant to whether there is a nexus between the claimed invention and the
`
`secondary considerations of non-obviousness regarding the SAPIEN 3 and, in
`
`particular, to disprove Petitioner’s contention (Paper 34 at 19-22) and Dr. Buller’s
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`opinion (Ex. 1045 ¶¶ 11-14) that the SAPIEN 3 does not include a fabric seal as
`
`claimed in the ‘608 patent.
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`-12-
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`
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`Observation #32. In Exhibit 2094, on page 68 lines 3 through 14, Dr. Buller
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`testified that he could not state that Figure 32 of the ‘608 patent would infringe the
`
`‘608 patent if the skirt were made of two pieces of material, rather than a single
`
`piece of material as shown. This testimony is relevant to whether there is a nexus
`
`between the claimed invention and the secondary considerations of non-
`
`obviousness regarding the SAPIEN 3 and, in particular, to demonstrate that Dr.
`
`Buller is confused by his own interpretation of “fabric seal,” as explained in
`
`Observation # 31.
`
`Observation #33. In Exhibit 2094, on page 68 line 15 through page 69
`
`line 17, Dr. Buller testified that the combination of the SAPIEN 3’s inner and outer
`
`skirts meets the claim elements of the ‘608 patent. This testimony is relevant to
`
`whether there is a nexus between the claimed invention and the secondary
`
`considerations of non-obviousness regarding the SAPIEN 3 and, in particular, to
`
`disprove Petitioner’s contention (Paper 34 at 17-22) and Dr. Buller’s opinion
`
`(Ex. 1045 ¶¶ 11-14) that the SAPIEN 3 does not include a fabric seal as claimed in
`
`the ‘608 patent.
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`Observation #34. In Exhibit 2094, on page 71 line 22 through page 72
`
`line 3, Dr. Buller testified that the SAPIEN 3’s commissure windows do not move
`
`independently of the frame. This testimony is relevant to whether there is a nexus
`
`between the claimed invention and the secondary considerations of
`
`-13-
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`
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`non-obviousness regarding the SAPIEN 3 and, in particular, to demonstrate that
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`Petitioner’s and Dr. Buller’s interpretation of the term “attached” is not the
`
`broadest reasonable interpretation. (See Reply at 19-23.)
`
`Observation #35. In Exhibit 2094, on page 76 line 7 through page 78 line 5,
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`Dr. Buller testified that two pieces welded together are not “attached,” but two
`
`pieces sutured together are “attached.” This testimony is relevant to whether there
`
`is a nexus between the claimed invention and the secondary considerations of
`
`non-obviousness regarding the SAPIEN 3 and, in particular, to demonstrate that
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`Petitioner’s and Dr. Buller’s interpretation of the term “attached” is not the
`
`broadest reasonable interpretation. (See Paper 34 at 19-23.)
`
`Observation #36. In Exhibit 2094, on page 78 line 6 through page 79 line 1,
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`Dr. Buller testified that he could not determine whether two pieces glued together
`
`would be “attached.” This testimony is relevant to whether there is a nexus
`
`between the claimed invention and the secondary considerations of
`
`non-obviousness regarding the SAPIEN 3 and, in particular, to demonstrate that
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`Petitioner’s and Dr. Buller’s interpretation of the term “attached” is not the
`
`broadest reasonable interpretation. (See Paper 34 at 19-23.)
`
`Observation #37. In Exhibit 2094, on page 79 line 15 through page 82
`
`line 18, Dr. Buller testified that the SAPIEN 3 includes a piece of fabric that is
`
`sutured around the frame and supports the commissures of the leaflets. This
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`-14-
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`
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`testimony is relevant to whether there is a nexus between the claimed invention
`
`and the secondary considerations of non-obviousness regarding the SAPIEN 3 and,
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`in particular, to disprove Petitioner’s contention (Paper 34 at 17-22) and
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`Dr. Buller’s opinion (Ex. 1045 ¶ 16) that the SAPIEN 3 does not include “a
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`replacement valve commissure support element attached to the expandable
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`anchor.”
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`Dated: November 3, 2017
`
`Respectfully submitted,
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`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
`
`Attorneys for Patent Owner Boston
`Scientific Scimed, Inc.
`
`-15-
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PATENT OWNER’S
`MOTION FOR OBSERVATIONS ON CROSS-EXAMINATION was served on
`November 3, 2017 to the following Counsel for Petitioner via e-mail:
`
`Gregory S. Cordrey (Reg. No. 44,089)
`Jeffer Mangels Butler & Mitchell, LLP
`3 Park Plaza, Suite 1100
`Irvine, CA 926214
`Email: gcordrey@jmbm.com
`Telephone: 949-623-7200
`Facsimile: 949-623-7201
`
`Brian Egan (Reg. No. 54,866)
`Morris, Nichols, Arsht & Tunnell, LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899-1347
`Email: began@MNAT.com
`Telephone: 302-351-9454
`Facsimile: 302-498-6216
`
`Catherine Nyarardy (Reg. No. 42,042)
`Paul, Weiss, Rifkind, Wharton &
`Garrison, LLP
`1285 Avenue of the Americas
`New York, NY 10019
`Email: cnyarardy@paulweiss.com
`Telephone: 212-373-3532
`Facsimile: 212-492-0532
`
`Attorneys for Petitioners Edwards LifeSciences Corporation, Edwards Lifesciences
`LLC, and Edwards Lifesciences AG
`
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`ARNOLD & PORTER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel:
`(213) 243-4000
`Fax: (213) 243-4199
`
`-i-
`
`