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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________
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`EDWARDS LIFESCIENCES CORPORATION, EDWARDS LIFESCIENCES
`LLC, AND EDWARDS LIFESCIENCES AG
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`Petitioners
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`v .
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`BOSTON SCIENTIFIC SCIMED, INC.
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`Patent Owner
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`_______________
`
`Case IPR2017-0060
`Patent 8,992,608
`_______________
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`PETITIONERS’ RESPONSE TO PATENT OWNER’S MOTION FOR
`OBSERVATIONS ON CROSS-EXAMINATION
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`Petitioners hereby respond to Patent Owner’s observations on the cross-
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`examinations of Larry Wood and Nigel P. Buller, M.D. (Paper No. 39).
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`I.
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`Responses to Observations on Cross-Examination of Larry Wood
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`Response to Observation #1. PO’s Observation is irrelevant and
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`misleading. Mr. Wood offered testimony with respect to secondary considerations
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`of nonobviousness based on his decades of experience in, inter alia, research and
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`development, operations, clinical development, commercialization and marketing
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`in the medical device industry and his more than 20 years of such experience in
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`prosthetic heart valves. E.g., Ex. 1046, ¶¶ 5–8. Mr. Wood does not need to meet
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`the definition of a person of ordinary skill in the art (“POSITA”) in the subject
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`matter of the ’608 Patent to have pertinent knowledge and expertise relevant to the
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`failure of others, long-felt but unmet need, copying, industry praise, unexpected
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`results, and commercial success in the prosthetic heart valve industry.
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`Response to Observation #2. PO’s Observation is irrelevant and
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`mischaracterizes the testimony. Consistent with his declaration testimony,
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`Mr. Wood confirmed in the testimony cited by PO that he is not offering “an
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`opinion regarding Boston Scientific’s efforts to match up the claim elements of the
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`’608 patent to the Sapien 3 device” but added “My understanding was Nigel Buller
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`was doing that” and that he deferred to Dr. Buller on that issue. Ex. 2096 at 10:3–
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`10; see also Ex. 1046, ¶ 9 (“I am aware that . . . Dr. Nigel Buller[] is also
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`1
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`submitting a declaration . . . which I understand includes an analysis rebutting
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`Patent Owner’s unsupported allegation that S3 infringes Claims 1-3 of the ’608
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`patent. I do not attempt to address the subjects covered by Dr. Buller.”). That Mr.
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`Wood is not also offering such an opinion has no relevance to PO’s failure to
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`establish a nexus between the claimed invention and the commercial success of the
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`SAPIEN 3.
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`Response to Observations #3–#19. Petitioners offer specific responses to
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`each of the Observations or Groups of Observations below. All of Observations
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`#3–#19, however, relate to PO’s purported evidence of secondary considerations of
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`non-obviousness based on Petitioners’ Sapien 3 product. All of these Observations
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`are irrelevant because, as Dr. Buller has explained, PO has failed to establish the
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`required nexus between Petitioners’ Sapien 3 and claims 1–4 of the ’608 Patent.
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`E.g. Ex. 1045 at ¶¶ 11-16.
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`Response to Observations #3, #4 & #5. PO’s Observations are incomplete,
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`misleading, and irrelevant to whether there was a long-felt but unmet need for a
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`solution to PVL. For example, PO takes Mr. Wood’s testimony and the underlying
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`documents out of context, and omits portions of Mr. Wood’s testimony where he
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`explains, inter alia, that “[Ex. 2019] also points out that patients that got the
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`[transapical] approach tend to have less paravalvular leak, but they had higher one-
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`year mortality. . . . So even though the [transapical] group had lower rates of
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`2
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`paravalvular leak, they still had a higher one-year mortality rate. So I think what
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`this paper points out is there’s a lot of confounding factors that aren’t related
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`necessarily to valve design, that have to do with imaging, that have to do with
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`baseline patient characteristics, and even have to do with the insertion approach”
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`(Ex. 2096 at 14:18-15:4) and “you’ll see [in Ex. 2100] the comparisons of TAVR
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`versus surgery. It’s been recorded in this paper that surgical valves had very little,
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`if not any, significant paravalvular leakage. So while there’s this purported
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`association with paravalvular leak and survival, you’ll notice at all time points
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`TAVR is equal or better than surgery, at all time points. . . . And so if paravalvular
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`leak were the end-all/be-all for mortality, then you would expect to see TAVR
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`have a much higher mortality than surgery, because we have PV leak and surgery
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`does not, but that’s just not shown in the data” (id. at 56:11-57:11). Further, PO
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`omits that the consideration is “long-felt but unmet need.” Mr. Wood’s testimony
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`is consistent with his opinion that there were already solutions for paravalvular
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`leak in 2004. See, e.g., Ex. 1046, ¶¶ 29–33.
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`Response to Observation #6. PO’s Observation is incomplete, misleading,
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`omits relevant testimony, and is not “relevant to whether there was a long-felt [but
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`unmet] need for a solution to PVL,” as PO asserts (Paper No. 39 at 2-3). Although
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`Mr. Wood testified that, in the abstract, “[e]veryone would rather have less [PVL]
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`than more [PVL],” in response to PO’s next question (“And if you can have less
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`3
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`paravalvular leak rather than more, that’s a positive, correct?”), Mr. Wood further
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`testified that, “Assuming there aren’t other tradeoffs. If my risk of stroke was
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`higher and my risk of paravalvular leak was less, I wouldn’t prefer to have stroke
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`over paravalvular leak.” Ex. 2096 at 16:17-25. Mr. Wood also testified that
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`paravalvular leak is not the “end-all/be-all for mortality.” Id. at 56:11-57:11; see
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`also id.at 14:18-15:4. Further, PO omits that the consideration is “long-felt but
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`unmet need.” Mr. Wood’s testimony is consistent with his opinion that there were
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`already solutions for paravalvular leak in 2004. See, e.g., Ex. 1046, ¶¶ 29–33.
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`Response to Observations #7, #8 & #9. PO’s Observations are incomplete,
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`misleading, confusing, and irrelevant. PO cites out of context Mr. Wood’s
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`statement that “Sapien 3 has less paravalvular leakage than XT at some level” (Ex.
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`2096 at 30:14-15). In fact, Mr. Wood explained at 30:14-31:10: “I believe Sapien
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`3 has less paravalvular leakage than XT at some level. Whether it’s statistically
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`significant or whether it’s just numerical, I couldn’t say for certain. . . . So it’s just
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`hard for me to be definitive about the degree of difference, given that we don’t
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`have a randomized trial between the two valves to make that assessment.” PO also
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`omits Mr. Wood’s testimony that: “I don’t know your definition of significant.
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`They [experienced] numerically less. But I believe, if you look at the PARTNER
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`II trial with Sapien XT and Sapien 3 in the PARTNER II trial, both looking at
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`intermediate-risk patients, there is a numerically lower rate, but I don’t believe
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`4
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`there’s a statistically significant lower rate of paravalvular leak with Sapien 3
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`versus XT in that study” (id. at 18:16-19:2); “And if you look at study limitations
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`[in Ex. 2059], they list a number of limitations with this study. And you’ll note the
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`sample sizes are relatively small. So I’m not refuting the findings of the paper, but
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`they have to be kept in context, if there’s 61 patients in the Sapien 3 group and 92
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`patients in the XT group, and it’s a retrospective assessment of patients that were
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`implanted over different time intervals, which indicates there could also be a
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`difference in clinical practice. So it’s an interesting paper, but it’s also a limited
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`paper” (id. at 22:7-20); see also id. at 21:1-15; Ex. 1046, ¶ 32. With respect to
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`oversizing to reduce paravalvular leak and that Ex. 2059 noted that less aggressive
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`oversizing is employed with Sapien 3, PO omits Mr. Wood’s testimony (consistent
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`with his declaration testimony (Ex. 1046, ¶¶ 29–30)) regarding the history of
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`oversizing and the role that improvements in imaging technology have played in
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`reducing the need for oversizing. Ex. 2096 at 26:6-27:22 (“In the beginning, we
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`used transthoracic echo to size the valves. Transthoracic echo is a 2D
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`measurement. It only measures really in one plane, so it makes a fundamental
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`assumption that the annulus is round. . . . So in a patient that’s 23 by 26, if you
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`measured in the 23 axis, you might decide on one valve; if you measured in the 26
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`axis, you might decide on a different size valve. And that’s why a lot of the
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`historical stuff around PV leak and around sizing was very imprecise. When we
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`5
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`moved to CT sizing, we would start to get area measurements which were more
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`precise, but it still requires the CT person to decide what landmarks they’re going
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`to utilize . . . . But in general, when we moved to CT sizing, now, whether it’s an
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`oval or whether it’s round, you [measure] the area of that annulus, however you
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`chose to mark it, and then you can measure the area of a fully deployed valve and
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`then decide which valve to choose.”). See also Ex. 1046, ¶ 30 (“Another way in
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`which PVL was successfully addressed prior to S3 was through ensuring that the
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`valves were placed correctly, as correct placement acts to reduce PVL. (P.O. Ex.
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`2059 at 463.) And finally, improvements in imaging allowed for both better
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`determination of the size of the patient’s anatomy and better visualization of the
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`placement of the device, leading to reduced PVL.”).
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`Response to Observation #10. PO’s Observation is confusing, incomplete,
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`and misleading because, inter alia, it omits Mr. Wood’s testimony regarding the
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`“environment” in question (the implantation site), in which he explains (Ex. 2096
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`at 34:10-23, 26:17-28:2) about the improvements in imaging techniques that have
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`enabled better evaluations of the dimensions of the annulus (which is more oval
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`than round), improving the ability to properly size devices: “As I talked about
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`earlier today, the use of 2D sizing and only looking at one plane, I think, was one
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`of the challenges, that we didn't fully understand why some valves leaked more
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`6
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`than others when we thought they were the same-size valve.” This is consistent
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`with Mr. Wood’s declaration testimony. Ex. 1046, ¶ 30.
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`Response to Observation #11. PO’s Observation is irrelevant to whether
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`Petitioners had independently conceived of using an outer seal as claimed in the
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`’608 Patent. Mr. Wood testified that a consideration in Petitioners’ decision not to
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`pursue an outer skirt in their previous commercial designs was an increase in crimp
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`profile. Ex. 2096 at 36:16–24. But Petitioners’ decision not to commercialize
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`their designs with outer skirts earlier than Sapien 3 has no bearing on whether or
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`not they independently conceived of an outer skirt before the ’608 Patent (Ex.
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`1046, ¶¶ 21–26). This testimony also does not show (as PO argues) “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” because, inter alia, changes in frame design in
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`the Sapien 3 reduced the profile in the delivery configuration over the Sapien XT,
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`as Mr. Wood has testified. See, e.g., Ex. 1046, ¶ 39.
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`Response to Observation #12. PO’s Observation is not relevant to
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`“whether Petitioner had independently conceived of the ‘608 patent,” as PO asserts
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`(Paper No. 39 at 5). Whether or not Petitioners pursued FDA approval or
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`commercialization of particular prototypes or design ideas is not relevant to
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`whether Petitioners independently conceived of those designs. Among other
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`7
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`things, as Mr. Wood explained in his declaration testimony, commercializing any
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`medical device is a long, complicated process. Ex. 1046, ¶ 26.
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`Response to Observation #13.
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` PO’s Observation
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`is
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`incomplete,
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`misleading, and mischaracterizes Mr. Wood’s testimony. For example, PO omits
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`the portion of Mr. Wood’s testimony regarding the tube valve prototype, where he
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`stated that “On the tube valve, if you’ll note, there’s a suture line. If you note the
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`skirt at the bottom, there’s a suture line that goes about halfway up the skirt, and
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`there’s no suture line along the top. So that top part of that skirt can actually fold
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`out somewhat. It’s not sewn down tightly, so that part of it is somewhat loose.”
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`Ex. 2096 at 38:16–24. This is consistent with Mr. Wood’s testimony that
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`Petitioners had previously independently conceived of the purported invention.
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`See, e.g., Ex. 1046, ¶¶ 21–23.
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`Response to Observation #14.
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` PO’s Observations are irrelevant,
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`misleading and mischaracterize Mr. Wood’s testimony. For example, when asked
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`about Ex. 2063, consistent with his declaration testimony (Ex. 1046, ¶ 37),
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`Mr. Wood stated repeatedly that “I really don’t know what this is” (Ex. 2096 at
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`40:8), “I was unfamiliar with it. I remain unfamiliar with it” (id. at 40:10–11),
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`“[A]gain, I don’t know what it is. I can’t comment any more than that” (id. at
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`40:23–24). Because, inter alia, this testimony does not authenticate the document
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`8
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`in question, contrary to PO’s statement it does not establish that the document is
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`evidence of unexpected results.
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`Response to Observation #15. PO’s Observation and Mr. Wood’s
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`testimony is not relevant to “whether the SAPIEN 3 received industry praise
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`directed specifically to its fabric seal” (Paper No. 39 at 6). That “some doctors”
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`attribute “some of the improved PVL data for the Sapien 3 to the skirt” (Ex. 2096
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`at 41:6-9) or that may be “a common belief, that the skirt contributes to reduction
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`of paravalvular leak” (id. at 42:21-22) is not “praise” or relevant to industry praise.
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`As Mr. Wood testified in his declaration, Sapien 3 has received praise for
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`improvements that have “nothing to do with S3’s outer skirt,” and Sapien 3 has
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`received criticism, as well. Ex. 1046, ¶ 36.
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`Response to Observations # 16 & #17. PO’s Observations are incomplete,
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`misleading, irrelevant, and mischaracterize Mr. Wood’s testimony. For example,
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`PO omits the portions of Mr. Wood’s testimony where he makes clear, consistent
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`with his declaration testimony on the importance of stroke and mortality outcomes
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`(Ex. 1046, ¶¶ 39–42) that “The main driver, I believe, that’s driven the popularity
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`of Sapien 3 is the fact that we have a 1 percent mortality rate and 1 percent
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`disabling stroke rate, which are far and away the best in class that anyone’s ever
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`seen with a transcatheter heart valve, in addition to having a pretty lower
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`pacemaker rate and low rates of other complications, including paravalvular leak.
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`9
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`But those 30-day outcomes, which are markedly different than all of the other
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`products that are out there. We have a four-times-lower mortality rate and a four-
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`times-lower stroke rate when compared to cardiac surgery in a matched patient
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`population. I believe that is the driver. And the difference in 30-day outcomes has
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`absolutely nothing to do with the skirt complications.” Ex. 2096 at 47:21–48:17;
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`see also id. at 49:2–7. In addition, contrary to the suggestion in PO’s observation,
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`the cited testimony does not refer to the fabric skirt of the Sapien 3 as the sole
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`reason for its popularity or success. For example, PO’s Observation omits Mr.
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`Wood’s testimony confirming his declaration testimony that that “it is not accurate
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`to attribute S3’s success simply to the outer skirt.” Ex. 2096 at 49:2-7; see also Ex.
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`1046, ¶¶ 39–42.
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`Response to Observation #18. PO’s Observation is misleading and
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`mischaracterizes Mr. Wood’s testimony. For example, Mr. Wood explained that
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`“We oftentimes see a spike in market growth when we launch a new product” (Ex.
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`2096 at 51:12-13) and that they also saw a spike when they “went from Sapien to
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`Sapien XT” (id. at 51:16-23). Further, Mr. Wood explained that the switch
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`“almost entirely from XT to Sapien 3” (Paper No. 39 at 7) was driven by
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`Petitioners’
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`intentional removal of
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`the previous generation product from
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`customers’ inventory (and that the volume of the switch was driven by Petitioners’
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`capacity) and not due to customer buying decision. .Exhibit 2096 at 52:3–23
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`10
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`(“What we do is we don’t want customers to have dual inventory on their shelf.
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`We don’t want them switching back and forth between two platforms. There’s a
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`chance they could get confused. And the techniques are different from valve to
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`valve, and the accessories are different valve to valve. So what we do is we go in
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`and we take back all of their old inventory and give them all new inventory of the
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`new product. So we try to swap everybody out as fast as we can, and it’s really
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`just driven by how much capacity we have at any given point in time. So you’ll
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`see we switched almost entirely from Sapien to Sapien XT, and then we switched
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`almost entirely from XT to Sapien 3. And I’ve never done a price increase from
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`one platform to the next. So the customer has every incentive to want the new
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`product, not to keep the old product, because there’s no advantage to them to have
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`the old product.”).
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`Response to Observation #19.
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` PO’s Observation
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`is
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`incomplete,
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`misleading, and irrelevant. PO cites out of context a statement regarding increase
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`in Sapien 3’s market share as “relevant to whether the Sapien 3 enjoyed
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`commercial success.” Paper No. 39 at 7. Even if PO had established a nexus
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`between Sapien 3 and claims 1-4 of the ’608 Patent, the “commercial success” of
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`Sapien 3 would only be relevant if it could be attributed to the purportedly
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`inventive sealing element. As Mr. Wood explained (consistent with his declaration
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`testimony (Ex. 1046, ¶¶ 39–42)), but PO omits, “The main driver, I believe, that’s
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`11
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`
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`driven the popularity of Sapien 3 is the fact that we have a 1 percent mortality rate
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`and 1 percent disabling stroke rate, which are far and away the best in class that
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`anyone’s ever seen with a transcatheter heart valve, in addition to having a pretty
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`lower pacemaker rate and low rates of other complications, including paravalvular
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`leak.” Ex. 2096 at 47:21–48:17; see also id. at 49:2–7; Ex. 1046, ¶ 39 (“The Patent
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`Owner’s attempt to argue, instead, that all of the success and popularity of S3 is
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`due only to the reductions we have seen in PVL is therefore contradicted by a
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`significant body of evidence—for example, the reduction in vascular complications
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`has been very important to physicians who implant TAVR devices. And
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`meaningful differences in mortality at 30 days, stroke, and vascular complications
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`cannot be attributed to a reduction in PVL.” (emphasis in original)), ¶ 40 (“[T]hat
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`the 23 mm and 26mm S3 valves can be delivered in a 14F sheath (as opposed to a
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`larger sheath) has directly
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`increased
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`the number of S3s
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`implanted. . . .
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`Additionally, because both Edwards and the SAPIEN line of valves had built up a
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`positive reputation with physicians, physicians felt comfortable immediately
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`switching to the new model, such that S3 was able to use the success of SAPIEN
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`and XT as a springboard.”).
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`II. Responses to Observations on Cross-Examination of Nigel P. Buller,
`M.D.
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`Response to Observation #20. PO’s Observation is misleading and
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`irrelevant. Dr. Buller previously opined (e.g., Ex. 1045, ¶¶ 9-16) and testified
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`12
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`again at his deposition (e.g., Ex. 2094 at 71:12-72:24, 75:1-76:6, 78:1-5, 78:16-
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`79:1) that PO failed to establish the required nexus between Petitioners’ Sapien 3
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`device and claims 1-4 of the ’608 Patent. Once Dr. Buller thus determined there
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`was no nexus between any of PO’s alleged secondary considerations and the
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`Challenged Claims (which applies to all of PO’s secondary considerations
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`arguments), there was no need for him to further address any specific secondary
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`considerations alleged by PO. Demaco Corp. v. F. Von Langsdorr Licensing Ltd.,
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`851 F.2d 1387, 1392 (Fed. Cir. 1988) (defining “nexus” as “a legally and factually
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`sufficient connection between the [secondary consideration] and the patented
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`invention”); Gnosis S.P.A. v. S. Ala. Med. Sci. Found., IPR 2013-116, Paper No. 68
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`at 38 (PTAB June 20, 2014) (“All types of objective evidence of nonobviousness
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`must be shown to have a nexus.”).
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`Response to Observations #21 & #22. PO’s Observations are confusing,
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`misleading, incomplete, irrelevant, and constitute improper attorney argument that
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`should be ignored. For example, the cited testimony about particular procedures
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`performed by Dr. Buller, does not contradict Dr. Buller’s extensive experience
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`relevant to the subject matter of the ’608 Patent, which has been the subject of
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`substantial testimony from Dr. Buller that is omitted from PO’s observation. Ex.
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`1007, ¶¶ 5–26 & Ex. A; Ex. 1035, ¶¶ 4–6; Ex. 2028 at 39:9–40:21, 48:17–58:16;
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`Ex. 2094 at 7:24–9:22, 9:23–12:21; 16:21–17:5.
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`13
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`Response to Observation #23. PO’s Observation is confusing and
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`mischaracterizes Dr. Buller’s testimony. Dr. Buller testified that Spenser (Ex.
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`1004) references both the stability of the construction of the valve and preventing
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`migration. Ex. 2094 at 20:4-14 (“[Y]es, it says stability. But it goes on to say, to
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`reduce migration, or words to that effect. . . . [I]t makes it clear what context it’s
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`using stability.”); 20:15-24 (“Again, it specifically says to reduce the risk of
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`movement or migration, or words to that effect, without looking at the passage. So
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`it makes it clear what it’s meaning in the context.”); 21:1-21 (“[Y]ou can talk about
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`stability, and people do and this patent does, stability of joining components
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`together. . . . And then there is the separate thing, there is stability for implantation
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`as a means to reduce the risk or prevent migration, for instance, and that sort of
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`stability. This PCT also talks about and makes it very clear when it’s talking about
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`that type of stability, because it talks about reducing migration.”). This testimony
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`is consistent with Dr. Buller’s opinion that it was known in the art that an outer
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`seal can prevent THV migration and that this was improperly ignored by Patent
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`Owner and its experts in interpreting the Spenser reference. Ex. 1045, ¶¶ 28-30.
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`Response to Observation #24.
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` PO’s Observation mis-states and
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`mischaracterizes Dr. Buller’s testimony and is not relevant to “whether a POSITA
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`would have combined Spenser’s valve with the AAA stent grafts’ skirts,” as PO
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`asserts (Paper No. 39 at 9). Dr. Buller does not state that the seal is “tightly
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`14
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`wrapped” around the stent, as PO argues (id.). See, e.g., Ex. 2094 at 22:14-24 (“In
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`the figures of the preferred embodiment, I think that's true; there's no -- there's no
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`space or if there is space, its filled in by another structure. Because there's some
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`cross-sections, like Figure 16, where it's not really labeled, it's not clear, but there
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`are multiple concentric circles, so there's -- appears there's something there rather
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`than space, but it's not really labeled.”). Moreover, Dr. Buller’s testimony is
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`consistent with his opinion that Bergheim teaches the use of an external skirt or
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`cuff “create[s] a seal between the valve structure and the aorta [and] prevents
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`perivalvular leak” and “may also prevent migration of the valve as the friction
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`between the valve device and the surrounding is increased.” Ex. 1045, ¶ 30.
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`Response to Observation #25.
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` PO’s Observation
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`is
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`incomplete,
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`misleading, and constitutes improper attorney argument that should be expunged or
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`disregarded. PO argues that the problem solved by the ’608 Patent is “PVL in
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`calcified diseased valves specifically” not “PVL generally.” To the extent it is
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`considered, PO omits, inter alia, Dr. Buller’s testimony at 37:6-38:8 (“[T]here are
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`lots of different sorts of diseased heart valves. There are calcified ones and
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`noncalcified ones . . . . [T]here are lots of conditions, there are lots of different
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`valves, four different valves in the heart, and the patent applies to treating all of
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`them. And the claim, particularly, is broad and applies to replacing a heart valve.
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`If I may add, the focus by Boston and Boston’s experts on calcification seems
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`15
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`extraordinary to me, because calcification just isn’t in the claim and it’s not in the
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`specification. There’s no teaching of calcification in the entire specification of the
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`’608 patent.”), 36:7-20 (“The ‘condition’ meaning the underlying diagnosis. They
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`might have aortic stenosis, they might have aortic regurgitation, they might have
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`pulmonary regurgitation. The teaching is of a heart valve to replace a heart valve.
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`And the specific teaching of using a seal is to prevent paravalvular regurgitation,
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`wherever it’s put and for whatever clinical condition it’s used.”), and 34:7-23
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`(“And, clearly, the claims we’re dealing with are not limited to aortic valve. The
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`claims apply as much to pulmonary valves that wouldn’t necessarily be
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`calcified . . . [T]hey certainly aren’t limited to the aortic valve, they’re not limited
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`to calcific valve, they’re not limited to elderly patients, and they’re certainly not
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`limited to senile calcific aortic stenosis. That is just a subset of patients to which
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`the claim applies.”). PO’s Observation also mis-characterizes Dr. Buller’s
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`declaration testimony, which directly address PO’s arguments attempting to limit
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`the challenged claims of the ’608 Patent to calcified valves. See, e.g., Ex. 1045,
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`¶¶ 40–47.
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`Response to Observation #26. PO’s Observation is confusing, incomplete,
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`misleading, and mischaracterizes Dr. Buller’s testimony, and is irrelevant to, inter
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`alia, Dr. Buller’s opinion that the claims of the ’608 Patent are not limited to
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`severely calcified aortic valves (Ex. 1045, ¶ 40). Dr. Buller testified: “Yes. They
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`would want to design it to work in a calcified environment. They may also want to
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`design it to work in a noncalcified environment, because they may want to design
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`it to use in conditions where the valve is not calcified. Both exist.” Ex. 2094 at
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`39:2-8; see also id. at 34:7-23, 36:7-20, 37:6-38:8.
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`Response to Observations #27, #28, & #29. PO’s Observations are
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`incorrect, incomplete, misleading, and irrelevant. Contrary to PO’s assertion, Dr.
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`Buller does not agree with Dr. Manganaro’s opinion that the nature of diseased
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`aortic annulus calcifications is fundamentally different that the nature of aortic
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`calcifications where stent grafts are implanted. PO omits, for example, the portion
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`of Dr. Buller’s testimony where he explains (consistent with his declaration
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`testimony (Ex. 1045, ¶¶ 40–47)) that “The only point that I’m making is that aortic
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`calcification is very common. People like Thornton, from the Thornton patent,
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`specifically considered it and talked about how it could interact with a stent graft
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`and particularly designed features of seals to address the problems of calcification
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`in the aorta that could occur when it’s present. The calcification is very common
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`in the aorta, and it interferes with the sealing function of stent grafts in the aorta.
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`And, therefore, designs such as Thornton were made to create the seal. And that is
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`the same sort of problem that can occur with a TAVR device.” Ex. 2094 at 45:1-
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`18; Ex. 1045, ¶ 43 (“Thornton, in discussing its Figure 20B embodiment, notes that
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`‘when apex strut (716) is anchored into the wall of abdominal aortic artery
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`17
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`(752) . . . it has been observed that the portion of main body (700) at and adjacent
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`to the apex strut (716) can be forced away from the artery wall particularly in case
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`of calcified tissue.’” (emphasis in Ex. 1045)), ¶ 44 (“Elliot provides that ‘Type I
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`endoleaks are also caused when circular prostheses are implanted in non-circular
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`aortic lumens, which may be caused by irregular vessel formation and/or calcified
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`topography of the lumen of the aorta AA.’” (emphasis in Ex. 1045)), ¶ 45 (“Thus,
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`both Thornton and Elliot confirm that in, e.g., aortic aneurysms, the landing zones
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`for stent graft prostheses may be calcified, in turn contradicting any suggestion that
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`reference to ‘healthy’ tissue in these publications means tissue free of calcification.
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`In my opinion, ‘healthy’ tissue refers, instead, only to the fact that it is tissue that is
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`not part of the aneurysmal sac.”). PO’s Observation is also irrelevant because, inter
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`alia, the claims are not limited to a calcified aortic annulus or even an aortic
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`annulus, as Dr. Buller testified. See, e.g., Ex. 2094 at 34:7-23 (“And, clearly, the
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`claims we’re dealing with are not limited to aortic valve. The claims apply as
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`much to pulmonary valves that wouldn’t necessarily be calcified . . . . [T]hey
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`certainly aren’t limited to the aortic valve, they’re not limited to calcific valve,
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`they’re not limited to elderly patients, and they’re certainly not limited to senile
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`calcific aortic stenosis. That is just a subset of patients to which the claim
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`applies.”); Ex. 1045, ¶ 40 (“[the challenged] Claims do not require native tissue
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`(i.e., native valve leaflets) with any degree of calcification, let alone severe
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`18
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`calcification. Nor, in my opinion, do these claims limit the purported invention to
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`the aortic valve”).
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`Response to Observation #30. Petitioners repeat, and adopt, their response
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`to Observations #27, #28, & #29 and further add that PO’s Observation here is also
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`confusing, misleading, and irrelevant. For example, the testimony cited by PO
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`(Ex. 2094, page 52, lines 1 through 5) says nothing about the Reaven and Sacks
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`study cited in the Jayalath Article. Further, as Dr. Buller explained in his
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`declaration testimony (Ex. 1045 at ¶¶ 46-47 (describing the Jayalath article as a
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`“review article . . . summariz[ing] 30 papers”)) and as he testified at deposition in
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`testimony omitted by PO, see Ex. 2094, page 39:22-40:5 (“[I]t’s a review of many
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`publications extending back over ten or more years before. So its relevance to me
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`is that it is a review article, it’s not itself original research, and it is just
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`summarizing lots of work that had been done in the field through the preceding
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`years.”), the Jayalath article is a review article collecting results from many
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`studies. That one underlying study group consisted of Hispanics with type 2
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`diabetes (as PO notes (Paper No. 39 at 12)) is not inconsistent with Dr. Buller’s
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`opinions (e.g., Ex. 1045, ¶¶ 40-47).
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`Response to Observations #31 & #32. PO’s Observations are incomplete
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`and misleading, mischaracterizes Dr. Buller’s testimony, lack proper context, and
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`are irrelevant to the issues in this proceeding. PO asserts secondary considerations
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`19
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`based on Petitioners’ Sapien 3, which features two skirts where the inner and outer
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`skirts are different. As Dr. Buller unequivocally opined (Ex. 1045, ¶¶ 11–14) and
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`testified on cross-examination (Ex. 2094 at, e.g., 52:20-24, 53:22-58:1, 60:11-
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`62:7), such a device does not infringe the ’608 Patent. E.g. Ex. 1045, ¶ 11 (“In my
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`opinion, SAPIEN 3 does not include the claim element ‘wherein a distal end of the
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`replacement valve leaflet is attached to the fabric seal and when the expandable
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`anchor is in the collapsed delivery configuration, the fabric seal extends from the
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`distal end of the replacement valve leaflet and back proximally over the
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`expandable anchor’ because SAPIEN 3 uses separate inner and outer skirts that
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`have different characteristics that are sewn together at the distal end of the device
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`(when implanted in the retrograde direction.”) (internal citation omitted)); ¶ 13
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`(“the skirt attached to the replacement valve leaflet (the inner skirt) does NOT
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`‘extend distally from the distal end of the replacement valve leaflet and back
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`proximally over the expandable anchor’ and is clearly not the same skirt that
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`purportedly forms flaps and prevents blood flow between the fabric seal and the
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`heart tissue, which is the outer skirt in SAPIEN 3 according to Patent Owner’s
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`allegations”); ¶ 14 (“Furthermore, in my opinion, the difference between SAPIEN
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`3’s two-skirt design and the ’608 Patent’s one-skirt design is significant.”)
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`(discussing the different functions of the different thread orientations in the inner
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`and outer skirts)); Ex. 2094 at, e.g., 52:20-24 (“Q. In your reply declaration, you
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`as
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