UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioners
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner
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`Case No. IPR2017-00444
`Patent 6,915,560
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`SUPPLEMENTAL DECLARATION OF NEIL SHEEHAN IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,915,560
`
`
`
`
`
`
`EDWARDS LIFESCIENCES EX. 1127
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00444
`
`
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioners
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. IPR2017-00444
`Patent 6,915,560
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`SUPPLEMENTAL DECLARATION OF NEIL SHEEHAN IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,915,560
`
`
`
`
`
`
`EDWARDS LIFESCIENCES EX. 1127
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00444
`
`
`
`
`
`I. INTRODUCTION
`
`A. Qualifications
`1.
`Patent Owner states that my opinions are entitled to little or no weight
`
`because I do not have experience designing stents or stent crimpers. Paper 15 at 2,
`
`13-15. Dr. Solar also questions whether my experience is sufficient to render
`
`opinions on whether Yasumi could be used to crimp a stent. Ex. 2016 at ¶ 61.
`
`2.
`
`I am more than qualified to render an opinion in this case. My
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`qualifications are summarized in my original declaration, Exhibit 1105 at ¶ 1-8,
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`and included in my Curriculum Vitae, Exhibit 1106. I provide a brief summary of
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`relevant portions herein.
`
`3.
`
`I have a degree in mechanical engineering from Villanova University.
`
`I also engaged in graduate studies at Harvard University in the Department of
`
`Engineering and Applied Physics.
`
`4.
`
`I have nearly 50 years of engineering experience, over 40 of which are
`
`in the medical device field. Over the course of my medical device career, I have
`
`worked at seven different medical device companies. I have held numerous
`
`positions, ranging from Product Development Engineer to Vice President of
`
`Engineering and Manufacturing.
`
`5.
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`For the past 25 years I have been working as a consulting engineer
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`and expert witness. In this capacity, I provide consulting engineering services both
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`-1-
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`
`
`
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`in a litigation context as well as in a product design and development context. I
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`specialize in medical device product design and development, and estimate that
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`over 95% of my consulting work over the years has been related to medical
`
`devices. All my expert witness work over the years has been related to medical
`
`devices.
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`6.
`
`I have forty two issued patents, forty of which are related to medical
`
`devices. More than half of my patents result from work I performed while a
`
`consultant, as opposed to work I performed while an employee or officer of a
`
`company.
`
`7.
`
`Although Patent Owner suggests that I have no experience with stents
`
`or stent crimping, Paper 15 at 13, during my deposition I noted that two of my
`
`previous expert witness engagements involved balloon catheters and stents. Ex.
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`2017 at 84:3-24, 85:11-23; see also id. at 81:17-23.
`
`8.
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`In particular, I was previously retained by the plaintiff in the patent
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`infringement matter Medtronic Vascular Inc. et al. v. Boston Scientific Corp. et al.
`
`(E.D. Tex. 2006). The technology at issue included balloon catheter devices for
`
`use with delivering stents. In the course of rendering my opinions in that case, I
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`was called upon to remove hundreds of stents from the balloon catheter products in
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`order to test the balloons.
`
`-2-
`
`
`
`
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`9.
`
`I also served as an expert for the defendant in the patent infringement
`
`matter Angioscore v. TriReme Medical (N.D.Cal. 2012). The technology at issue
`
`involved an angioplasty balloon catheter including a non-deployable stent adapted
`
`to be secured to the balloon. In the course of rendering my opinions in that case, I
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`spent considerable time investigating how the accused TriReme Chocolate® brand
`
`percutaneous transluminal angioplasty catheter was made. In fact, I tested many of
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`them. Through this investigation and testing I gained experience regarding how
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`the stent portion was put on the balloon portion and reduced in size (i.e., crimped).
`
`10.
`
`Finally, I have been retained by Petitioner to serve as an expert in the
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`district court litigation related to the present IPR proceeding. In that capacity, I
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`have reviewed design and engineering documents related to Petitioner’s accused
`
`heart valve crimpers. I have also inspected or reviewed photographs of several
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`crimpers involved in the district court litigation.
`
`11.
`
`I consider my work as an expert witness to be part of my engineering
`
`consulting activities. Both product design and development consulting and expert
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`witness consulting require me to engage my engineering skills to address the
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`technology at issue. Therefore, I am more than familiar with the design and
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`operation of stents and stent crimpers through my consulting work, including my
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`expert witness consulting.
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`-3-
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`
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`12.
`
`It is true that I have not crimped a stent using a mechanical device like
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`the one described in the ’560 patent. I also note that Dr. Solar does not indicate
`
`that he has ever used a mechanical device like the one described in the ’560 patent
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`to crimp a stent. Nevertheless, I am able to understand the operation of the
`
`invention and to determine what a POSITA would have understood at the time of
`
`the invention in view of the available prior art. The ’560 patent is a relatively
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`straightforward mechanical system for reducing the size of a tubular object, and I
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`have been working with mechanical devices my entire career.
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`13.
`
`Patent Owner also alleges that I rely on unsupported, conclusory
`
`assertions to support my opinions. Paper 15 at 16. To the contrary, my original
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`declaration, Exhibit 1105, includes an extensive discussion of the ’560 patent, the
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`prior art to the ’560 patent, and what a POSITA would have understood based on
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`the disclosures of each document. This provides credible evidence that supports
`
`my opinions.
`
`14.
`
`Patent Owner alleges that I advertise my expert witness services
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`through three online services. Paper 15 at 15. I do advertise my expert witness
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`services using JurisPro. See Ex. 2018. I do not have a relationship with the other
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`two online services. See Exs. 2019-20. I am not familiar with these services and
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`have never contacted or been contacted by them regarding posting my expert
`
`qualifications. To the extent they have information about my expert witness
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`-4-
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`
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`qualifications and experience, they appear to have gathered that information
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`independently from publicly available sources. For example, I can confirm that the
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`picture used in Exhibit 2019 was taken from my LinkedIn profile. It is not a
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`picture I personally would have selected for an expert directory. The picture I
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`would have selected is shown in Exhibit 2018, which shows my JurisPro profile
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`and selected picture.
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`15.
`
`Patent Owner alleges that my income from 2014-2016 was derived
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`solely from my expert witness work. Paper 15 at 15 n.2. This is misleading for
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`two reasons. First, it ignores 2017. A significant portion of my income in 2017
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`came from a consulting engagement unrelated to litigation. Second, it suggests
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`that the only work I performed in 2014-2016 was expert witness work. This is not
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`true. I undertake a significant amount of consulting work outside the expert
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`witness field advising young entrepreneurs with start-up companies. I perform this
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`consulting work pro bono. My pro bono work has been increasing steadily over
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`the past few years. As I approach full retirement, I find that I still enjoy consulting
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`and particularly enjoy guiding younger people, but they need their money more
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`than I do. Patent Owner’s attempt to capitalize on my charitable nature to malign
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`my credibility is disappointing.
`
`B. Operation Of Yasumi Figure 8 Embodiment
`16.
`Dr. Solar misunderstands several aspects of the Yasumi disclosure.
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`-5-
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`
`
`
`17.
`
`Dr. Solar ties the utility of the Yasumi invention to changing the size
`
`of an electric wire. For example, Dr. Solar states that Yasumi “is directed to an
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`aperture setting device that could be used with a drawing die, a chuck, a press tool
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`(or the like) to change the polygonal size of an electric wire or the like. . . . There
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`was a need to change the size of a polygonal configuration of an electric wire.” Ex.
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`2016 at ¶ 35. Dr. Solar’s summary and characterization of Yasumi are inaccurate.
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`18.
`
`A POSITA would not have read the Yasumi disclosure in this manner.
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`As I noted in my original expert declaration, Yasumi is broadly directed to an
`
`aperture setting device. Ex. 1105 at ¶ 96. This is the basic function of Yasumi,
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`repeatedly stated throughout the specification. See Ex. 1103 at Abstract, 1:8-13,
`
`1:40-43, 4:58-60. Yasumi explains that such a device would be useful in a number
`
`of applications, and provides examples of “a chuck, a press tool, an electric wire
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`guide device, a drawing die, a control valve and so forth.” Id. at 1:35-39. None of
`
`these examples relate to forming or shaping an electric wire. Although one
`
`example does refer to an electric wire (i.e., an electric wire guide device), id. at
`
`9:35-37, such a device is used to guide a threaded wire into a pin connector so the
`
`connector can be crimped securely onto the wire. It is not used to change the size
`
`or shape of the wire itself.
`
`19.
`
`Additionally, Figure 8 of the Yasumi patent relates to a press tool.
`
`The specification explains that a “linear member” is placed in the hole and formed,
`
`-6-
`
`
`
`
`
`and identifies an electric wire as one exemplary “linear member.” Id. at 9:22-34.
`
`However, a POSITA would not focus on forming an electric wire as the only, or
`
`even the primary, utility of the tool. The specification’s use of the broader term
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`“linear member” suggests any generally straight object. It would have been clear
`
`to a POSITA that an electric wire is just an example of a linear member. Thus, Dr.
`
`Solar’s repeated suggestion that Yasumi is limited to forming an electric wire is
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`simply not how a POSITA would read the specification.
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`20.
`
`Dr. Solar states that the Figure 8 disclosure lacks sufficient detail or
`
`clarity to indicate how the Figure 8 embodiment would operate to achieve its
`
`intended purpose. Ex. 2016 at ¶ 38. I disagree.
`
`21.
`
`As an initial matter, I explained the operation of Figure 8 in my
`
`original declaration. Ex. 1105 at ¶¶103-04. Dr. Solar does not address my
`
`explanation in his response or suggest that it is inaccurate.
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`22.
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`Dr. Solar’s confusion appears to stem from his inability to understand
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`the operation of the setting piece in relation to the movable handle. See Ex. 1105
`
`at ¶ 40; Ex. 1126 at 43:3-44:19. Dr. Solar appears perplexed by the disclosure in
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`Yasumi that (1) by rotating the movable handle 37 closer to the fixed handle 26,
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`the setting piece 32 also turns; (2) the setting piece butts against the fixed handle
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`when a set angle is reached, thereby limiting further rotation of the setting piece
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`-7-
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`
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`and fixing the pins, and (3) after the setting piece is fixed, the movable handle 37
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`continues to move closer to the fixed handle 26. Id.
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`23.
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`What Dr. Solar fails to appreciate is that the setting piece 32 (blue)
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`and the movable handle 37 (purple) at times rotate together, and at other times do
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`not. Ex. 1103 at 8:42-54. The fixed handle 26 (blue), movable handle 37 (purple),
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`and setting piece 32 (blue) are coupled together in the manner described in the
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`specification, id. at 8:1-41, such that the movable handle is rotatable relative to the
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`fixed handle, id. at 8:42-45. When the movable handle 37 (purple) is first moved
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`towards the fixed handle 26 (blue), the setting piece 32 (blue) will also move. Id.
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`at 8:45-47. This coordinated movement of the movable handle 37 (purple) and the
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`setting piece 32 (blue) stops once the setting piece butts against the adjust cam 31
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`on the fixed handle 26 (blue), thereby fixing the drive pins 45 (blue). At this point,
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`further rotation of the setting piece is stopped by the adjust cam 31, but the
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`movable handle 37 (purple) can still rotate because it does not butt against the
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`adjust cam 31. Id. at 8:46-50. Accordingly, the continued rotation of the movable
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`handle 37 (purple) towards the fixed handle 26 (blue) turns the circular frame 20
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`(purple) relative to the now fixed drive pins 45 (blue), and results in movement of
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`the movable pieces. Id. at 8:46-50. The drive pins 45 (blue) no longer move,
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`imposing a force on the movable pieces as the movable handle continues to rotate
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`that causes the movable pieces to move inward or outward. Id. at 8:50-54.
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`-8-
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`24.
`
`This is really no different from the Figure 3 embodiment, which Dr.
`
`Solar appears to understand. See Ex. 2016 ¶¶ 38-39. In Figure 3, the movable
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`pieces 12-19 (green) move along the guide grooves 39 of the frame 20 (purple)
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`when the guide base 21 (blue) turns relative to the frame 20 (purple). Ex. 1103 at
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`5:39-6:13.
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`-9-
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`
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`Circular Frame 20
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`Movable Pieces 12-19
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`Drive Pins 22-1 - 22-8
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`
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`25.
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`The same principles apply to Figure 8. Ex. 1103 at 5:39-40, 7:33-38.
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`Figure 8 simply adds the ability to set the opening of the aperture using the setting
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`piece 32 (blue). Id. at 8:10-11, 9:3-15. However, once the setting piece 32 (blue)
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`engages the adjust cam 31 to set the size of the aperture, the operation of the Figure
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`8 embodiment closely mirrors that of Figure 3. The setting piece 32 will remain
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`stationary along with the fixed handle 26, drive pins 45, screws 46, and support
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`discs 41 and 42 (all depicted in blue). Id. at 8:1-54. These blue components serve
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`the same function as the guide base in Figure 3.
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`26.
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`Movable handle 37 (purple) continues to turn frame 20 (purple)
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`relative to the now blue “guide base” components. This has the same result as
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`-10-
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`
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`
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`turning the frame relative to the guide base in Figure 3. The movable pieces 12-17
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`(green) move along the guide grooves 39 of the frame 20 (purple). Id.
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`27.
`
`As I mentioned in my initial declaration, a POSITA would have had at
`
`least a Bachelor of Science degree in mechanical engineering, industrial design,
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`biomedical engineering or equivalent work experience. Ex. 1105 at ¶ 66.
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`Someone with this background would have no trouble understanding the operation
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`of Figure 8.
`
`C. Yasumi Discloses Limitations Relating To At Least One Stationary
`End-Wall “Operatively Engaged” To The Dies “At Distinct Connection
`Locations”
`28.
`
`Dr. Solar disputes that Yasumi discloses movable pieces “operatively
`
`engaged” with either side plate 27-1 or 27-2. Ex. 2016 at ¶ 48-50. I disagree.
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`29.
`
`I explained the operative engagement between the movable pieces and
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`the side plates in detail in my opening declaration. Ex. 1105 at ¶¶ 95-104, 126 (at
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`pp. 68-69).
`
`30.
`
`The movable pieces 12 to 17 (green) are operatively engaged to
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`support discs 41 and 42 (blue) and setting piece 32 (blue) via drive pins 45 (blue).
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`The drive pins 45 (blue) extend through elongated holes (23-1 to 23-6) in the
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`moveable pieces (green), as well as through holes (36-21 to 36-26) in the support
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`-11-
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`
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`
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`disc 41 (blue), holes (36-31 to 36-36) in the support disc 42 (blue), and holes (36-
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`11 to 36-16) in the setting piece 32 (blue). Ex. 1103 at 8:27-34.1
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`31.
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`The movable pieces 12 to 17 (green), support discs 41 and 42 (blue),
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`and setting piece 32 (blue) are in turn are operatively engaged to side plates 27-1
`
`and 27-2 (blue) of the fixed handle 26 (blue). Specifically, support disc 42 (blue)
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`is operatively engaged to side plate 27-2 (blue) via a larger outer flange 70 that
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`rests against the outside of side plate 27-2, and a smaller inner portion that passes
`
`through side plate 27-2. Id. at 8:1-9. Support disc 41 (blue) is operatively engaged
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`to fixed handle side plate 27-1 (blue) by resting against the outside of the side plate
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`27-1. Id. at 8:23-27. Setting piece 32 (blue) is operatively engaged to fixed handle
`
`side plates 27-1 and 27-2 (blue) where it butts against adjust cam 31 on fixed
`
`handle 26 (blue). Id. at 8:45-50; see also id. at 9:26-30.
`
`
`1 Dr. Solar admits that the movable pieces 12 to 17 are operatively engaged to
`support discs 41 and 42 via drive pins 45. Ex. 2016 at ¶¶ 49, 52; Ex. 1126 at
`52:25-53:7. Oddly, he does not address whether the movable pieces 12 to 17 are
`similarly operatively engaged to the setting piece 32 via drive pins 45, despite the
`fact that the drive pins 45 extend through holes in each of the support discs 41 and
`42 and the setting piece 32.
`
`-12-
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`
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`
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`32.
`
`The above-described engagements are an operative engagement
`
`because each is necessary for the Yasumi press tool to operate. The parties did not
`
`seek a construction of “operatively engaged,” so I have applied the ordinary and
`
`customary meaning, as would be understood by one of ordinary skill in the art in
`
`the context of the specification. Operatively engaged simply means engaged in a
`
`way that furthers the operation, or that the engagement produces the intended
`
`effect.
`
`33.
`
`Support discs 41 and 42 (blue) are designed to rotate around a central
`
`axis that goes through the hole 43. A POSITA skilled in mechanical engineering
`
`would understand that without the engagement between the support discs 41 and
`
`-13-
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`
`
`
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`42 (blue) and the side plates 27-1 and 27-2, stable rotation along the central axis
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`would not be possible. Additionally, a POSITA skilled in mechanical engineering
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`would understand that the movable pieces can’t move until the pins are fixed, and
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`this only happens when the setting piece 32 (blue) butts against the fixed handle
`
`adjust cam 31, thus fixing the pins in place. Before the setting piece butts against
`
`the adjust cam 31, the pins are not fixed. Rotating the movable handle 37 (purple)
`
`will rotate the circular frame 20 (purple) along with the movable pieces fitted
`
`within the frame. The movable pieces in turn will rotate the drive pins 45 (blue),
`
`along with the support disks 41 and 42 (blue) and setting piece 32 (blue) which are
`
`not fixed in place yet. Accordingly, the engagement between the movable pieces
`
`(green), drive pins 45 (blue), support disks 41 and 42 (blue), and setting piece 32
`
`(blue) constitutes an operative engagement with the side plates 27-1 and 27-2
`
`(blue) because the engagement is necessary to operate the tool.
`
`34.
`
`To better understand the operative engagement, it is helpful to first
`
`review the simpler embodiment disclosed in Figure 3. In Figure 3, the movable
`
`pieces 12-19 (green) are operatively engaged to the guide base 21 (blue). This is
`
`because the guide base 21 (blue) has drive pins 22-1 to 22-8 (blue) that extend
`
`through holes 23-1 to 23-8 in the movable pieces 12-19 (green), thereby engaging
`
`the movable pieces. Id. at 5:57-6:7. In operation, the drive pins 22-1 to 22-8
`
`-14-
`
`
`
`
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`(blue) move the pieces 12-19 (green) along the frame 20 (purple) the distance “d”
`
`when the frame 20 (purple) rotates relative to the guide base 21 (blue). Id. at 6:1-8.
`
`
`
`
`
`Guide Base 21
`
`Circular Frame 20
`
`Movable Pieces 12-19
`
`Drive Pins 22-1 - 22-8
`
`
`
`35.
`
`The operative engagement between movable pieces 12-17 (green) and
`
`side plates 27-1 and 27-2 (blue) in Figure 8 mirrors that in Figure 3. The
`
`combination of the support discs 41 and 42 (blue), the setting piece 32 (blue), and
`
`the side plates 27-1 and 27-2 (blue) in Figure 8 act together as the guide base 21
`
`(blue) in Figure 3. Once the setting piece butts against the fixed handle 26 (blue),
`
`the setting piece 32 (blue), the drive pins 45 and screws 46 (blue), the support discs
`
`-15-
`
`
`
`
`
`41 and 42 (blue), and the fixed handle 26 (blue) remain stationary. Ex. 1103 at
`
`8:47-50. Upon further movement of the movable handle 37 (purple) toward fixed
`
`handle 26, the drive pins 45 (blue) move the pieces 12-17 (green) along the frame
`
`20 (purple) the distance “D” when the frame 20 (purple) rotates relative to the
`
`stationary components (blue). Id. at 7:46-52.
`
`
`
`36.
`
`This constitutes an operative engagement between the movable pieces
`
`12-17 (green) and the side plates 27-1 and 27-2 (blue). Without the fixed side
`
`plates 27-1 and 27-2 (blue) to stop rotation of the setting piece 32 (blue), the drive
`
`
`
`-16-
`
`
`
`
`
`pins 45 (blue), and the support discs 41 and 42 (blue), the movable pieces 12-17
`
`(green) would not move. The press tool would not operate.
`
`37.
`
`Although Dr. Solar also admits that the first support disc (42 in Fig. 8)
`
`is fitted into a circular recess of side plate 27-2, he does not concede that they are
`
`engaged, never mind operatively engaged. Ex. 2016 at ¶ 49. His opinion is based
`
`on the alleged lack of an explicit disclosure in Yasumi that there is an engagement
`
`between the support disk and the side plate. Ex. 1126 at 52:25-57:2; 60:2-61:7.
`
`But a POSITA applying basic engineering principles would understand that the
`
`components are operatively engaged for the reasons discussed above. Although Dr.
`
`Solar’s background may not be sufficient to understand Yasumi, to claim that a
`
`POSITA cannot tell from Yasumi whether the support disc and the side plate are
`
`engaged ignores the technical acumen a POSITA would bring to the table when
`
`reading Yasumi.
`
`38.
`
`Dr. Solar seems to suggest that the claimed “operative engagement”
`
`requires a direct connection between the movable pieces and the side plates, such
`
`as the direct connection that would occur if the side plate(s) had holes that were
`
`connected via drive pins to the corresponding holes in the movable pieces. Ex.
`
`2016 at ¶ 50; Ex. 1126 at 59:11-15. I disagree.
`
`39.
`
`There is nothing in the claims stating that operative engagement
`
`means a direct connection. Such an interpretation is not supported by the
`
`-17-
`
`
`
`
`
`specification either. Indeed, each of the preferred embodiments in the specification
`
`depicts an indirect operative engagement between the dies and the stationary end
`
`walls via multiple components.
`
`Non-rotating Plate 156
`
`Linear Slide
`
`Bearing Block 212
`
`Actuation Plate 142
`
`Cam Follower Bearing 150
`
`Slot 146
`
`Connecting Link 130
`
`Blade 106
`
`
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`For example, as depicted in FIG. 4c, the blade 106 (green) is connected to a
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`connecting link 130 (red), which in turn is connected to a bearing block 212, which
`
`in turn is connected to a linear slide (yellow), which finally is connected to the
`
`non-rotating plate 156 (blue). Ex. 1101 at 5:33-41. Dr. Solar admitted as much
`
`during his deposition. Ex. 1126 at 52:2-12.
`
`40.
`
`Dr. Solar disputes that there can be an indirect operative engagement
`
`by way of the support discs 41 and 42 because “there is no disclosure that any
`
`operative engagement occurs between any support disc and a side plate.” Ex. 2016
`
`at ¶ 51. I disagree. For the reasons discussed above, there is an operative
`
`-18-
`
`
`
`
`
`engagement between the support discs 41 and 42 (blue) and the side plates 27-1
`
`and 27-2 (blue).
`
`41.
`
`Dr. Solar seems to suggest that the claimed “operative engagement”
`
`requires that the support discs be fixed to, and not moving relative to, the side
`
`plates. Ex. 2016 at ¶ 51. I disagree.
`
`42.
`
`There is nothing in the claims stating that operative engagement
`
`means fixed to, and no requirement that the components remain stationary. This
`
`interpretation is not supported by the specification either. Indeed, in each of the
`
`preferred embodiments there are moving components in the operative engagement.
`
`For example, as depicted in FIG. 4c, the blade 106 (green) is engaged to the non-
`
`rotating plate 156 in part via a connecting link 130 (red) and a bearing block 212.
`
`In operation, the connecting link 130 (red) and bearing block 212 will slide along a
`
`linear slide on the non-rotating plate 156. Thus, the components that make up the
`
`operative engagement are not all stationary with respect to the non-rotating plate
`
`156.
`
`43.
`
`Nevertheless, although there is no claim limitation requiring the
`
`support discs 41 and 42 (blue) to be fixed to, and not moving relative to, the side
`
`plates 27-1 and 27-2 (blue) in order to be “operatively engaged,” Yasumi discloses
`
`this feature. As previously explained, and the support discs 41 and 42 (blue) are
`
`fixed relative to, and remain stationary relative to, the side plates 27-1 and 27-2
`
`-19-
`
`
`
`
`
`(blue) once the setting piece 32 (blue) butts against the fixed handle adjust cam 31.
`
`Ex. 1101 at 8:27-50.
`
`44.
`
`Dr. Solar states that “claims 1-2, 6, and 8-9 require operative
`
`engagement between the dies and a stationary end-wall at distinct connection
`
`locations.” Ex. 2016 at ¶ 47 (emphasis omitted). Dr. Solar further states that my
`
`declaration cited no disclosure in Yasumi showing that “the movable pieces are
`
`operatively engaged with either plate at ‘distinct connection locations.’” Id. at 48.
`
`I disagree.
`
`45.
`
`As an initial matter, Dr. Solar has reversed the language used in the
`
`claims, which impacts the meaning of the claim limitation. Claim 1 and its
`
`dependents require “at least one of the stationary end-walls operatively engaged to
`
`the dies at distinct connection locations.” Thus, the recited “distinct connection
`
`locations” are on the dies, not on the stationary end-walls. Dr. Solar acknowledged
`
`this during his deposition. Ex. 1126 at 46:6-47:7. I identified in my declaration
`
`the elongated hole on each movable piece as the “distinct connection locations”
`
`ultimately operatively engaging the movable piece to the side plates 27-1 or 27-2
`
`(blue). This is all that is required by the claim limitation.
`
`-20-
`
`
`
`
`
`D. Yasumi Discloses Limitations Relating To Inward and Outward
`Movement of the Dies
`46.
`
`Dr. Solar states that Yasumi does not disclose the limitations directed
`
`to inward or outward movement of the dies. Ex. 2016 at ¶¶ 54-56. Dr. Solar’s
`
`analysis is in error for two reasons.
`
`47.
`
`First, Dr. Solar describes the “linear” movement of the dies according
`
`to a preferred embodiment described in the ’560 patent, Ex. 2016 at ¶¶ 31-32, and
`
`then suggests (without stating it explicitly) that the claims require this same
`
`“linear” motion, id. at ¶¶ 53-56. I do not read the claims this narrowly. Nor would
`
`a POSITA.
`
`48.
`
`The claim language does not explicitly recite “linear” movement.
`
`Although some the preferred embodiments move in a manner that could be
`
`described as linear, I don’t see any language in the specification that would suggest
`
`to a POSITA that linear motion is required. It appears that Patent Owner did
`
`originally include such limitations in the originally filed claims. See e.g., Ex. 1102
`
`at 149 (including limitations directed to “wherein each blade includes a single
`
`radial point which a) lies on a radial line of the reference circle prior to movement
`
`of the blade, and b) may be moved only along the radial line of the reference circle
`
`on movement of the blade” and “each blade is mounted to a linear slide device,
`
`each linear slide device movable along an axis parallel to the radius on which the
`
`radial point of the blade lies.”) Patent Owner cancelled the original claims after
`
`-21-
`
`
`
`
`
`receiving a restriction requirement and submitted a new set of claims. This new set
`
`of claims did not include the “linear” motion limitations. Id. at 93-96. Moreover,
`
`Patent Owner never referenced “linear” motion to distinguish any of the prior art
`
`during prosecution. For example, the Examiner relied on Whitesell as teaching
`
`dies that move inward to reduce the size of the aperture and outward to increase the
`
`size of the aperture. Ex. 1102 at 73. Whitesell has dies that pivot to increase or
`
`decrease the size of the aperture. Ex. 1115. Whitesell touts its invention as an
`
`improvement over “linear motion devices.” Id. at Abstract. Yet Patent Owner
`
`never tried to distinguish Whitesell as not disclosing linear inward and outward
`
`movement of the dies. For these reasons, a POSITA would not understand the
`
`claimed inward or outward motion to require “linear” motion.
`
`49.
`
`Under the plain language of the claims, the movable pieces in Yasumi
`
`move inward or outward as discussed in my original Declaration. Ex. 1105 at ¶¶
`
`95-104, 127-129, 136 (at pp. 84-85). Dr. Solar does not appear to dispute that the
`
`pieces move inward or outward according to the plain meaning of those terms. Ex.
`
`1126 at 65:8-66:13.
`
`50.
`
`Second, Dr. Solar misunderstands the disclosure in Yasumi regarding
`
`how the movable pieces move. Dr. Solar claims that the movable pieces of Figure
`
`8 move in a circumferential manner, or with some sort of “windmill like” or
`
`-22-
`
`
`
`
`
`rotational movement, as opposed to inward and outward. Ex. 2016 at ¶ 56. Dr.
`
`Solar is wrong.
`
`51.
`
`Yasumi discloses that the “inner peripheral configuration of the frame
`
`20 conforms substantially to a windmill-like outer peripheral configuration formed
`
`by the moveable pieces 12 to 19 as a whole.” Ex. 1103 at 5:45-48. This disclosure
`
`does not indicate that the pieces move like a windmill. Instead, it is directed to the
`
`configuration of the moveable pieces in the frame, not the motion of those pieces.
`
`52.
`
`I explained the motion of the movable pieces in my opening expert
`
`declaration. Ex. 1105 at ¶¶ 95-104, 127-129, 136 (at pp. 84-85). The movable
`
`pieces don’t spin or move like a windmill. They move just like the dies described
`
`in the ’560 patent. Each movable piece is disposed within a circular frame 20
`
`(purple) and the base of the piece can move along the frame a certain distance,
`
`labeled “d” in Fig. 3 and “D” in Figure 10. Ex. 1103 at 5:48-51, 7:48-52, see also
`
`id. at 3:12-23, 8:50-54. In this way “the movable pieces are moved along their
`
`bases to approach the axis 0.” Id. at 6:7-8. Moving the movable pieces towards
`
`the axis 0, which is located at the center of the aperture, constitutes moving them
`
`“inward.” Correspondingly, moving the movable pieces away from the axis 0
`
`constitutes moving them “outward.”
`
`53.
`
`The figures below illustrate the movement of the movable pieces
`
`approximately halfway along the distance “d” in Figure 3. As can be seen,
`
`-23-
`
`
`
`
`
`movement of the bases along “d” translates the movement of the flat side forming
`
`the aperture. Like the dies in the ’560 patent, the tip of each movable piece moves
`
`in and out along a radius of a reference circle centered on the axis 0.
`
`-24-
`
`
`
`
`
`
`
`
`
`
`
`-25-
`
`-25-
`
`
`
`
`
`E.
`
`The Yasumi Press Tool Is A Crimper That Would Be Suitable For
`Crimping A Stent
`54.
`
`Dr. Solar disagrees with my opinion that a POSITA would have
`
`understood the Yasumi press tool to be a crimper. Ex. 2016 at ¶ 60 n.5. Dr. Solar
`
`appears to base his disagreement on the lack of an explicit reference to crimping in
`
`Yasumi. Id.
`
`55.
`
`My opinion that a POSITA would have understood the Yasumi press
`
`tool to be a crimper flows naturally from the description of how the Yasumi press
`
`tool operates (which I discussed in detail in my opening declaration, Ex. 1105 at
`
`¶¶ 95-111), and need not find support in an explicit reference to “crimping.”
`
`56.
`
`Dr. Solar notes that crimping in the context outside of stent
`
`applications involves “affixing an object (such as a connector) to another object
`
`(such as a cable).” Ex. 2016 at ¶ 60 n.5. I agree, and this is precisely why a
`
`POSITA would understand Yasumi to disclose a crimper. The way a crimper
`
`affixes an object to another object is by compressing one onto the other, and
`
`Yasumi teaches a tool for doing just that.
`
`57.
`
`Specifically, Figure 8 is described as “a manual forming and pressing
`
`tool” for compressing a “liner member.” Ex. 1101 at 7:33-35. “A linear member
`
`to be formed, such as an electric wire or the like, is inserted into the hole . . . the
`
`member to be formed is subjected to a sufficiently large pressure by the movable
`
`pieces 12 to 17 and readily formed into a predetermined shape.” Id. at 9:22-34. A
`
`-26-
`
`
`
`
`
`POSITA would understand from this passage that the press tool is a crimper
`
`because it is a tool that can be used to crimp one object onto another by exerting a
`
`“sufficiently large pressure” on the object to be crimped.
`
`58.
`
`Dr. Solar further disagrees with my opinion that the Yasumi press tool
`
`would be suitable for crimping a stent, and again alleges that I failed to support
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