Filed on behalf of:
`Edwards Lifesciences Corporation
`By: Craig S. Summers
`Brenton R. Babcock
`Christy G. Lea
`Cheryl T. Burgess
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`Email: BoxEdwards-4@knobbe.com
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner
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`Case No. IPR2017-00444
`Patent 6,915,560
`
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`PETITIONER’S REPLY IN SUPPORT OF PETITION FOR INTER
`PARTES REVIEW OF U.S. PATENT NO. 6,915,560
`
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`
`Edwards Lifesciences Corporation
`By: Craig S. Summers
`Brenton R. Babcock
`Christy G. Lea
`Cheryl T. Burgess
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`Email: BoxEdwards-4@knobbe.com
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner
`
`
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`Case No. IPR2017-00444
`Patent 6,915,560
`
`
`
`
`
`
`
`
`PETITIONER’S REPLY IN SUPPORT OF PETITION FOR INTER
`PARTES REVIEW OF U.S. PATENT NO. 6,915,560
`
`
`
`
`
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`
`
`TABLE OF CONTENTS
`
`
`Page No.
`
`
`INTRODUCTION ........................................................................................... 1
`
`I.
`
`II. ARGUMENT ................................................................................................... 3
`
`A. Mr. Sheehan Is Well-Qualified To Express Opinions In This
`Case ....................................................................................................... 3
`
`B.
`
`The Preamble “A stent crimper” Is Not Limiting ................................. 6
`
`C. Ground 1: Yasumi Discloses Each Claim Limitation .......................... 9
`
`1.
`
`2.
`
`3.
`
`Yasumi discloses dies operatively engaged to a stationary
`end-wall ....................................................................................... 9
`
`Yasumi discloses dies that move inward and outward to
`change the size of the aperture .................................................. 15
`
`If necessary, a POSITA would have been motivated to use
`Yasumi’s press tool as a stent crimper ...................................... 18
`
`D. Ground 2: A POSITA Would Have Been Motivated To Combine
`Yasumi With Morales ......................................................................... 23
`
`E.
`
`There Are No Secondary Considerations That Support
`Nonobviousness ................................................................................... 23
`
`1.
`
`2.
`
`There is no evidence of commercial success ............................ 23
`
`There is no evidence of a long-felt but unresolved need or
`failure of others ......................................................................... 25
`
`III. CONCLUSION .............................................................................................. 26
`
`
`
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`
`Page No(s).
`
`
`
`Apple Inc. v. Samsung Elecs. Co.
`839 F.3d 1034, 1057 (Fed. Cir. 2016) ................................................................ 25
`
`B/E Aerospace, Inc. v. MAG Aerospace Indust., LLC,
`IPR2014-01511, Paper 104, 2016 ......................................................................... 4
`
`Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) .............................................................................. 8
`
`Circuit Check Inc. v. QXQ INC.,
`795 F.3d 1331 (Fed. Cir. 2015) .......................................................................... 26
`
`In re Cyclobenzaprine Hydrochloride,
`676 F.3d 1063 (Fed. Cir. 2012) .................................................................... 25, 26
`
`Deere & Co. v. Bush Hog, LLC,
`703 F.3d 1349 (Fed. Cir. 2012) ........................................................................ 7, 8
`
`Georgetown Rail Equip. Co. v. Holland LP,
`867 F.3d 1229 (Fed. Cir. 2017) ........................................................................ 8, 9
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 18
`
`In re Kubin,
`561 F.3d 1351 (Fed. Cir. 2009) .......................................................................... 20
`
`Ex Parte Mick J Perez-Cruet,
`2010-007447, 2012 WL 32279 (B.P.A.I. Jan. 3, 2012)........................................ 8
`
`SEB S.A. v. Montgomery Ward & Co. Inc.,
`594 F.3d 1360 (Fed. Cir. 2010) ............................................................................ 4
`
`
`
`ii
`
`
`
`IPR2017-00444
`Edwards v. Boston Scientific
`Exhibit No.
`
`Description
`
`1101
`
`1102
`
`1103
`
`1104
`
`1105
`
`1106
`
`1107
`
`1108
`
`1109
`
`1110
`
`1111
`
`1112
`
`1113
`
`1114
`
`1115
`
`1116
`
`1117
`
`1118
`
`U.S. Patent No. 6,915,560 (“the ’560 patent”)
`
`U.S. Patent No. 6,915,560 File History Excerpts
`
`U.S. Patent No. 4,454,657 (“Yasumi”)
`
`U.S. Patent No. 5,893,852 (“Morales”)
`
`Declaration of Neil Sheehan in Support of Petition for Inter Partes
`Review of U.S. Patent No. 6,915,560
`
`Curriculum Vitae of Neil Sheehan
`
`Materials Considered by Neil Sheehan
`
`German Patent No. DE9034 (“Nix”)
`
`Certified Translation of Nix
`
`U.S. Patent No. 2,664,996 (“Andrews”)
`
`U.S. Patent No. 4,308,744 (“Baker”)
`
`International Patent Publication No. WO1994014573 A1
`(“Hartley”)
`
`U.S. Patent No. 5,918,511 (“Sabbaghian”)
`
`U.S. Patent No. 6,364,870 (“Pinchasik”)
`
`U.S. Patent No. 5,261,263 (“Whitesell”)
`
`U.S. Patent No. 3,695,087 (“Tuberman”)
`
`U.S. Patent No. 6,176,116 (“Wilhelm”)
`
`U.S. Patent No. 6,051,002 (“Morales 2”)
`
`Exhibit List, Page 1
`
`
`
`IPR2017-00444
`Edwards v. Boston Scientific
`Exhibit No.
`
`Description
`
`1119
`
`1120
`
`1121
`
`1122
`
`1123
`
`1124
`
`1125
`
`1126
`
`1127
`
`1128
`
`1129
`
`
`
`U.S. Patent No. 5,951,540 (“Verbeek”)
`
`U.S. Patent No. 7,892,201 (“Laguna”)
`
`U.S. Patent No. 6,125,523 (“Brown”)
`
`U.S. Patent No. 3,370,451(“Schuetz”)
`
`U.S. Patent No. 3,154,978 (“Baker 2”)
`
`U.S. Patent No. 3,417,598 (“Valente”)
`
`U.S. Patent No. 6,074,381 (“Dinh”)
`
`November 27, 2017 Deposition of Dr. Ronald. J Solar PhD.
`
`Supplemental Declaration of Neil Sheehan in Support of Petition
`for Inter Partes Review of U.S. Patent No. 6,915,560
`
`Invention Disclosure (Ex. 2112) (AEO)
`
`7/24/2017 Supplemental Response to BSC’s Interrogatory No. 8
`
`Exhibit List, Page 2
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`Boston’s opening argument attacks the qualifications of Edwards’ expert,
`
`Neil Sheehan, a highly experienced mechanical engineer with over 40 years of
`
`experience in the medical device industry. Mr. Sheehan is fully qualified to opine
`
`regarding what a POSITA would know about the structure and operation of tools to
`
`crimp stents and other objects. In contrast, Boston’s expert, Ronald Solar, has
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`degrees in metallurgy, materials science, and biomaterials. In his deposition, Dr.
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`Solar admitted that he does not know how the Yasumi tool operates.
`
`Boston’s arguments on the merits are no more compelling. Boston argues
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`that the preamble is limiting and that Yasumi does not disclose a “stent crimper.”
`
`The Board has already considered and rejected these arguments. Boston does not
`
`dispute that the claims recite structurally complete inventions in the absence of the
`
`preamble. Nor does Boston deny that the specification describes other uses for the
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`“inventive apparatus,” such as a crimper for other medical devices and a balloon
`
`mold, which are structurally identical to the disclosed stent crimper. Nothing
`
`suggests that Boston intended to exclude these other uses from the claims. Far
`
`from “breathing life and meaning” into the claims, the preamble merely identifies
`
`one preferred use of the invention.
`
`Boston next argues that Yasumi fails to disclose dies “operatively engaged”
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`to a stationary end-wall because the movable pieces are not directly engaged or
`
`1
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`
`
`
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`“affixed” to a side plate. Yet, the claims do not require dies directly engaged or
`
`affixed to a stationary end-wall. They require only dies “operatively engaged” to a
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`stationary end-wall. Yasumi discloses an operative engagement between the
`
`movable pieces (dies) and the side plates (stationary end-walls) via a connection of
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`multiple components, just like the crimper disclosed in the ’560 patent.
`
`Boston also argues that Yasumi’s movable pieces do not move “inward” and
`
`“outward” to change the size of the aperture. This argument lacks merit given
`
`Yasumi’s disclosure regarding how the movable pieces move to open and close the
`
`aperture, which is only possible if the pieces move “inward” and “outward.” To
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`the extent Boston suggests that the claimed die movement must be “linear,” Boston
`
`improperly imports a limitation from the specification into the claims.
`
`Boston further argues that a POSITA would not be motivated to use Yasumi
`
`as a stent crimper. Boston incorrectly presumes that the preamble is limiting.
`
`Boston also ignores abundant evidence that persons of ordinary skill were using
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`hand-operated tools (like pliers) to crimp stents. This evidence, combined with the
`
`well-known desire to crimp a stent uniformly, provides ample motivation to utilize
`
`Yasumi—a press tool designed to uniformly compress an object from all sides—to
`
`crimp a stent.
`
`Boston also challenges obviousness based on alleged secondary
`
`considerations of nonobviousness. Yet, Boston offers only conclusory arguments
`
`2
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`
`
`
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`and fails to provide evidence which ties the patented features to any secondary
`
`considerations. For example, Boston offers no evidence of a nexus between the
`
`commercial success of Edwards’ heart valve crimpers and the challenged claims,
`
`nor is there any evidence of a long-felt but unresolved need or failure of others.
`
`II. ARGUMENT
`
`A. Mr. Sheehan Is Well-Qualified To Express Opinions In This Case
`Boston does not dispute that a POSITA would have had, among other things,
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`a Bachelor of Science in mechanical engineering or equivalent work experience,
`
`and five to ten years of experience in the design or development of medical
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`devices. Paper 1 at 30-31. As a mechanical engineer with nearly 50 years of
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`engineering experience (over 40 in the medical device field), Neil Sheehan is well-
`
`qualified to testify in this matter.
`
`Mr. Sheehan’s formal education
`
`includes a degree
`
`in mechanical
`
`engineering from Villanova, and graduate studies in the Engineering and Applied
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`Physics department at Harvard. His work experience includes high-level positions
`
`at seven different medical devices companies. He has worked for the past 25 years
`
`as a consulting engineer and expert witness, specializing almost exclusively in
`
`medical device products. Mr. Sheehan is also familiar with the design and
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`operation of stents and stent crimpers
`
`through previous expert witness
`
`3
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`
`
`
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`engagements involving balloon catheters and stents. Ex. 1127 ¶¶ 1-12; Exhibit
`
`1105 ¶ 1-8; Ex. 1106; Ex. 2017 at 81:17-23, 84:3-24, 85:11-23.
`
`Boston ignores these qualifications, choosing instead to rely on out-of-
`
`context sound bites from Mr. Sheehan’s deposition to attack his fitness to serve as
`
`an expert. Mr. Sheehan need not have designed or used a stent or a stent crimper
`
`to qualify as an expert. SEB S.A. v. Montgomery Ward & Co. Inc., 594 F.3d 1360,
`
`1373 (Fed. Cir. 2010) (expert was qualified even though he himself was not skilled
`
`in designing deep fryers); B/E Aerospace, Inc. v. MAG Aerospace Indust., LLC,
`
`IPR2014-01511, Paper 104, 2016 Pat. App. LEXIS 7579, *21-23 (Mar. 18, 2016)
`
`(hands-on experience is not necessary as long as the expert’s qualifications
`
`sufficiently align with the challenged subject matter).
`
`As a highly experienced mechanical engineer and medical device consultant,
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`mechanical devices like the patented crimper and Yasumi press tool are squarely
`
`within Mr. Sheehan’s area of expertise. Mr. Sheehan’s education, training, and
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`experience make him well-qualified to give testimony on the operation of the ’560
`
`patent and the prior art, and what would have been known and obvious to a
`
`POSITA.1
`
`
`1 Patent Owner’s “evidence” to denigrate Mr. Sheehan’s qualifications is
`misleading. Paper 15 at 2, 15 n.2, 30. Mr. Sheehan advertises his expert witness
`services on JurisPro, but has no relationship with the other identified sites. His
`income in recent years, including 2017, is not solely from expert witness work, but
`includes non-litigation consulting work and guiding entrepreneurs and start-ups on
`
`4
`
`
`
`
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`Boston’s assertion that Mr. Sheehan’s opinions are conclusory and
`
`unsupported is incorrect. Mr. Sheehan’s declaration included a discussion of
`
`stents, stent crimpers, the ’560 patent, and the prior art. Ex. 1105. This, along
`
`with Mr. Sheehan’s expertise, provides support for his opinions. Ex. 1127 ¶ 13.
`
`Boston asserts that Dr. Solar is more qualified and that his opinions should
`
`be given more weight. Paper 15 at 15. Upon closer inspection, however, Dr.
`
`Solar’s experience is not as advertised.
`
`Dr. Solar’s education is in metallurgy, materials science, and biomaterials,
`
`disciplines that focus on the study of material properties. Ex. 1126 at 13:16-15:7.
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`He does not have a degree in mechanical engineering, industrial design, or
`
`biomedical engineering, as would the agreed-upon POSITA.
`
`Boston highlights Dr. Solar’s two crimper patents to buttress his experience.
`
`Yet, these two patents relate to a single crimping device, which never made it
`
`beyond the prototype stage, and that uses a fluid compressed bladder to crimp a
`
`stent. Ex. 1126 at 20:5-22:15. This technology is nothing like the ’560 crimper or
`
`the Yasumi press tool.
`
`
`a pro bono basis. Ex. 1127 ¶¶ 14-15; Ex. 2017 at 8:20-10:5. There is nothing
`wrong or unsavory about how Mr. Sheehan spends his time working as an expert,
`consultant, and volunteer as he approaches the end of a long and distinguished
`career (he is currently 71).
`
`
`5
`
`
`
`
`
`Given Dr. Solar’s background, it is no surprise that he has admitted that he
`
`does not understand how the Yasumi press tool operates. Ex. 2016 ¶¶ 40, 68; Ex.
`
`1126 at 43:3-44:19, 54:2-57:2. In the end, Dr. Solar misunderstands important
`
`features regarding the operation of Yasumi relevant to the obviousness analysis.
`
`Ex. 1127 ¶¶ 16-27, 50-53. If any expert’s opinion is entitled to more weight, the
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`Board should credit Mr. Sheehan, who understands the references underlying the
`
`Petition.
`
`B.
`
`The Preamble “A stent crimper” Is Not Limiting
`
`Boston’s arguments that the preamble is limiting are a repeat of those the
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`Board previously found unpersuasive at the institution stage. Paper 9 at 9-10.
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`Boston claims the preamble “breathes life and meaning” into the claims
`
`because the patent contains disclosure directed to solving the problem of uneven
`
`stent crimping. Paper 15 at 18-20. In making this argument, Boston all but
`
`ignores the extensive disclosure in the specification directed to substantial other
`
`uses for the “inventive apparatus.” They include using the device: (1) to
`
`manipulate other, non-stent medical devices; and (2) as a balloon mold. Ex. 1101
`
`at 2:48-55, 3:20-22, 8:65-9:62, Figs. 12-13.
`
`Boston’s response to these substantial other uses is relegated to a single
`
`conclusory sentence buried in a footnote: “[T]he specification’s acknowledgement
`
`of other uses of a stent crimper does not alter the fact that the ’560 patent was
`
`6
`
`
`
`
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`directed to the particular problem of stent crimping.” Paper 15 at 23, fn. 4
`
`(emphasis added).
`
`Boston’s characterization of the specification is incorrect. The specification
`
`does not acknowledge other uses of a “stent crimper.” It broadly teaches that the
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`“inventive apparatus”—not a stent crimper—finds utility “in crimping” and “in
`
`reducing the diameter of a medical device such as those mentioned above,” and
`
`that it “may also be used as a variable size balloon mold.” See e.g., Ex. 1101 at
`
`3:14-22, 3:36-37, 8:65-67.
`
`Boston does not dispute that the claims recite structurally complete
`
`inventions in the absence of the preamble. Nor has Boston identified any evidence
`
`of an intent to exclude the substantial other uses discussed above from the claims.
`
`Indeed, the fact that Boston has asserted infringement of the ’560 patent by
`
`Edwards’ heart valve crimper, which is not a stent crimper, contradicts its position
`
`that the claims are limited to “a stent crimper.”
`
`The cases cited by Boston do not support its position either. In each of those
`
`cases, the specification described a single, specific application of the invention.
`
`For example, in Deere & Co. v. Bush Hog, LLC, the specification repeatedly
`
`referred to the “present invention” as a “rotary cutter deck” and the title, summary
`
`of the invention, and every drawing described the invention as a rotary cutter deck.
`
`7
`
`
`
`
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`703 F.3d 1349, 1358 (Fed. Cir. 2012). This led the court to conclude that the
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`preamble “rotary cutter deck” was limiting. Id.
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`In contrast, where the specification provides broad disclosure of multiple
`
`alternative applications for the invention, as here, the case law holds that the
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`preamble is not limiting. For example, in Ex Parte Mick J Perez-Cruet, the Board
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`held that the preamble was not limiting because “the Specification makes it clear
`
`that the device is open to other uses.” Appeal 2010-007447, 2012 WL 32279 at 4
`
`(B.P.A.I. Jan. 3, 2012). In Georgetown Rail Equip. Co. v. Holland LP, the Federal
`
`Circuit held that the preamble “mounted on a vehicle for movement along the
`
`railroad track” was not limiting because the specification discussed alternatives to
`
`affixing the processing device to a vehicle. 867 F.3d 1229, 1236-37 (Fed. Cir.
`
`2017).
`
`Boston’s argument that the Claim 36 preamble is limiting because it
`
`provides antecedent basis for that claim, and hence all preambles should be treated
`
`as limiting, is misplaced. Dependence on a phrase for antecedent basis “may limit
`
`claim scope.” Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d
`
`801, 808-09 (Fed. Cir. 2002) (emphasis in original). There is no rule that it must
`
`do so. Moreover, even if the preamble were limiting in Claim 36, it does not
`
`follow that the other claim preambles are too. Id. at 810-11 (preamble limiting
`
`where it appeared in both the preamble and body of a single claim, but not limiting
`
`8
`
`
`
`
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`for remaining claims where it appeared in preamble alone). If anything, Claim 36
`
`demonstrates that Boston knew how to include a limitation to a stent crimper in the
`
`body of the claims, yet chose not to do so for all but Claim 36.
`
`Boston has not provided any persuasive reasoning to depart from the general
`
`rule that claim preambles are not limiting. Georgetown Rail, 867 F.3d at 1236.
`
`Accordingly, the Board should maintain its previous determination that the
`
`preamble “a stent crimper” is not limiting.
`
`C. Ground 1: Yasumi Discloses Each Claim Limitation
`
`Boston contends that Yasumi does not disclose the preamble, a “stent
`
`crimper.” Because the preamble is not limiting, Yasumi need not disclose this
`
`intended use. If the Board finds the preamble limiting, it would have been obvious
`
`to use Yasumi as a stent crimper. See Section II.C.3.
`
`The only other claim limitations that Boston contends are missing are (1)
`
`dies “operatively engaged” to a stationary end-wall, and (2) dies that move
`
`“inward” and “outward” to change the size of the aperture.
`
`1.
`
`Yasumi discloses dies operatively engaged to a stationary
`end-wall
`
`The “operative engagement” between the movable pieces 12-17 (dies) and
`
`the fixed handle side plates 27-1 and 27-2 (stationary end-walls) was explained in
`
`detail in the Petition (Paper 1 at 38-43, 55-56) and in Mr. Sheehan’s declaration
`
`(Ex. 1105 ¶¶ 95-104, 122, 126). See also Ex. 1127 ¶¶ 20-37.
`
`9
`
`
`
`
`
`Specifically, the movable pieces 12-17 (green) are held within frame 20
`
`(purple) by projections 40 (red) that fit within guide grooves 39 in the frame. The
`
`movable pieces 12-17 are operatively engaged to the setting piece 32 (blue) and the
`
`support discs 41 and 42 (blue) via drive pins 45 (blue). These drive pins 45 extend
`
`through elongated holes in the moveable pieces, as well as through corresponding
`
`holes in the setting piece 32, support disc 41, and support disc 42. Ex. 1103 at
`
`8:27-32.
`
`The support discs 41 and 42 (blue) and setting piece 32 (blue) are, in turn,
`
`operatively engaged to side plates 27-1 and 27-2 of the fixed handle 26 (blue).
`
`Specifically, the support disc 41, which is larger than the hole 28-1, is placed on
`
`
`
`10
`
`
`
`
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`the outside of the side plate 27-1 to cover the hole 28-1. The support disc 42 is
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`fitted into the hole 28-2 of the side plate 27-2, and has a flange 70 that is urged
`
`against the outside of the side plate 27-2. Ex. 1103 at 8:1-9, 8:23-27.2
`
`Once the drive pins 45 are inserted through the holes in the movable pieces,
`
`the support discs and the setting piece, the screws 46 are screwed into the drive
`
`pins. This connection urges the support discs 41 and 42 against the side plates 27-
`
`1 and 27-2 and connects the fixed handle 26 (blue), the movable handle 37 (purple)
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`and the setting piece 32 (blue). Ex. 1103 at 8:32-45.
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`To crimp an object within the aperture formed by the movable pieces 12-17,
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`the movable handle 37 (purple) is rotated toward the fixed handle 26 (blue).
`
`Initially, when bringing the movable handle 37 (purple) closer to the fixed handle
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`26 (blue), the setting piece 32 (blue) also turns. Id. at 8:42-47. As the setting piece
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`32 (blue) turns, so must the drive pins 45 (blue) and the support discs 41 and 42
`
`(blue): the support disc 41 rotates relative to the outer surface of the side plate 27-
`
`1, and the support disc 42 rotates within the hole 28-2 of the side plate 27-2. Ex.
`
`1127 ¶ 33.
`
`
`2 During his deposition, Dr. Solar refused to agree that this constituted an
`engagement at all, let alone an operative engagement. He claimed that Yasumi’s
`disclosure is insufficient, arguing that it “doesn’t state that it’s engaged.” Dr. Solar
`even went so far as to say: “There’s no written description that gives me any
`information on how that’s connected. It’s just there.” Ex. 1126 at 54:2-57:2. Dr.
`Solar’s positions are not credible and ignore the technical acumen that would be
`possessed by a POSITA when reading Yasumi. Ex. 1127 ¶ 37.
`
`11
`
`
`
`
`
`Once a set angle is reached, the setting piece 32 (blue) butts against the
`
`adjust cam 31 on the fixed handle 26 (blue). At that point, further rotation of the
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`setting piece 32 is halted. Further movement of the drive pins 45 and support discs
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`41 and 42 (all depicted in blue) is also halted, causing the drive pins 45 to remain
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`stationary relative to the fixed handle 26. Id. at 8:1-54. These blue components
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`thereafter act like the guide base in Figure 3.
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`Continued movement of the movable handle 37 (purple) toward the fixed
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`handle 26 (blue) turns the frame 20 (purple) relative to the now fixed blue
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`components, including the now fixed drive pins 45. This movement causes the
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`drive pins (positioned within the elongated holes 23-1 to 23-6) to move the
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`movable pieces along the guide grooves 39 of the frame to close the aperture. Id.
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`Despite this detailed disclosure, Boston contends there is no operative
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`engagement between Yasumi’s movable pieces 12-17 and the side plates 27-1 and
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`27-2 for two reasons.
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`First, Boston argues that the movable pieces 12-17 are not operatively
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`engaged to the side plates 27-1 and 27-2 because the movable pieces are connected
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`to the support discs 41 and 42 and not the side plates. Boston admits that the
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`support discs 41 and 42 are operatively engaged to the movable pieces 12-17 at
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`distinct connection locations, but contends that the side plates 27-1 and 27-2 are
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`not so engaged. Paper 15 at 27. To the extent Boston is arguing that the movable
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`12
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`
`
`
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`pieces must be engaged with the side plates without any intervening components,
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`Boston is incorrect.
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`Every embodiment in the ’560 patent shows the dies engaged to the
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`stationary end-walls through multiple components. Ex. 1127 ¶¶ 38-39. For
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`example, Figure 4c shows the blades (dies) 106 connected to a non-rotating plate
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`(stationary end-wall) 156 via three separate components: (1) a connecting link 130
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`(red), (2) a linear bearing block 212 (red), and (3) a linear slide (yellow) (identified
`
`as reference number 154 in other figures).
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`Non-rotating Plate 156
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`Linear Slide
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`Bearing Block 212
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`Actuation Plate 142
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`Cam Follower Bearing 150
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`Slot 146
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`Connecting Link 130
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`Blade 106
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`
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`In his deposition, Dr. Solar begrudgingly admitted each of these multiple-
`
`component connections after first speculating that “it could be made in one piece.”
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`Ex. 1126 at 50:18-52:12. That it takes several components to operatively engage
`
`the blades and the non-rotating plates in the ’560 patent contradicts Boston’s
`
`13
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`
`
`
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`argument that there must be a more direct connection between the movable pieces
`
`and side plates in Yasumi. Indeed, if Yasumi’s movable pieces were not
`
`operatively engaged with the side plates, the Yasumi device would not work. Ex.
`
`1127 ¶¶ 28-37.
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`Second, Boston argues that the claims require the movable pieces, support
`
`discs, and setting piece to be affixed to the side plates. Paper 15 at 26-27 (“[T]here
`
`is no evidence that the movable pieces, the support discs, or the setting piece is
`
`affixed to any side plate (for example by drive pins or screws).”). Boston also
`
`seems to argue that there must be “distinct connection locations” on the side plates
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`of Yasumi, such as holes, drive pins, or screws, in order to operatively engage the
`
`movable pieces. Id. Boston provides an illustration to make its point:
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`Boston’s arguments are confusing and reflect a misunderstanding of
`
`Yasumi. First, the “distinct connection locations” recited in the claims are
`
`locations on the dies, not the stationary end-walls. Ex. 1126 at 46:10-47:7; Ex.
`
`
`
`14
`
`
`
`
`
`1127 ¶¶ 44-45. Indeed, Boston has admitted that Yasumi discloses this claim
`
`limitation (“the support discs 41 and 42 of Yasumi are operatively engaged to
`
`movable pieces 12 to 17 (and at distinct connection locations) . . . .)” Paper 15 at
`
`27. Accordingly, Boston’s argument that Yasumi’s side plates lack distinct
`
`connection locations is irrelevant.
`
`Second, if the movable pieces were “affixed to any side plate (for example
`
`by drive pins or screws),” as Boston suggests, the movable pieces would not be
`
`“movable” and, thus, could not open and close the aperture. To the extent Boston
`
`argues that the setting piece 32 and support discs 41 and 42 must be “affixed” to
`
`the side plates, there is no requirement in the claims that anything be “affixed.”
`
`But, as explained above, the setting piece 32 and support discs 41 and 42 are held
`
`stationary relative to the side plates when the setting piece butts against the adjust
`
`cam 31.
`
`2.
`
`Yasumi discloses dies that move inward and outward to
`change the size of the aperture
`
`Edwards detailed how Yasumi’s movable pieces 12-17 (dies) move
`
`“inward” to close the aperture and “outward” to open the aperture in its Petition
`
`(Paper 1 at 38-43, 61, 72, 80) and Mr. Sheehan’s declaration (Ex. 1105 ¶¶ 95-104,
`
`127-129, 136, 140, 150-151).
`
`Generally, Yasumi discloses an aperture setting device that can change the
`
`size of a polygonal aperture. Ex. 1103 at 1:8-13, Abstract, 1:40-43. To do so, the
`
`15
`
`
`
`
`
`movable pieces are moved either closer to or farther from the center of the
`
`aperture. Id. at 6:7-8, 7:46-57, 8:50-54. Nothing more is required by the plain
`
`words of the claims. See Ex. 1126 at 65:8-66:13.
`
`To the extent Boston argues that Yasumi does not disclose these limitations
`
`because Yasumi’s movable pieces do not move in a “linear” fashion, Boston’s
`
`argument improperly imports a limitation from the specification into the claims.
`
`Ex. 1127 ¶¶ 46-49.
`
`“Linear” die motion is not explicitly recited in any claim. Likewise, the
`
`plain and ordinary meaning of the words “inward” and “outward” does not
`
`implicitly require “linear” motion. In fact, Boston originally sought, but then
`
`dropped, claims to linear die motion. Ex. 1102 at 93-96, 149.
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`Moreover, although not required, Yasumi does disclose the same linear
`
`motion described in the ’560 patent, not the “circumferential” or “windmill like”
`
`motion Boston suggests. Yasumi refers to a “windmill-like outer peripheral
`
`configuration” to describe the configuration of the movable pieces in the frame 20,
`
`not the motion of those pieces. Ex. 1127 ¶ 51. The movable pieces are confined to
`
`move along the inner surface of the frame 20 the distance “d” in Figure 3 and the
`
`distance “D” in Figure 8. Ex. 1103 at 3:12-23, 5:48-51, 6:7-8, 7:48-52, 8:50-54.
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`This motion, depicted below in reference to Figure 3, is the same linear motion
`
`16
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`
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`
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`disclosed in the ’560 patent. Ex. 1127 ¶¶ 50-53. As depicted below, the tip of
`
`each triangular piece moves linearly towards the axis 0 of the aperture. Id.
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`
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`17
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`
`
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`
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`3.
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`If necessary, a POSITA would have been motivated to use
`Yasumi’s press tool as a stent crimper
`
`Boston argues that a POSITA would not have found it obvious to use
`
`Yasumi as a stent crimper because there is no statement in Yasumi that it can be
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`used as a stent crimper. Boston’s argument is misplaced.
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`Yasumi need not explicitly recite stent crimping to render the challenged
`
`claims obvious. As an initial matter, the preamble is not limiting for the reasons
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`discussed above. Many of the claims are therefore not limited to stent crimping.
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`For the dependent claims that have stent limitations (Claims 11, 17, 19, 26,
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`34, 35, 39), a POSITA would have found it obvious to use Yasumi as a stent
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`crimper. Ex. 1105 ¶¶ 81-92, 155-60; Ex. 1127 ¶¶ 54-81. Under KSR Int’l Co. v.
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`18
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`
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`Teleflex Inc., 550 U.S. 398, 415-421 (2007), the Supreme Court identified a
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`number of alternative rationales that support a conclusion of obviousness here,
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`such as (1) use of known techniques to improve similar devices in the same way,
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`or (2) known work in one field of endeavor that may prompt variations of it for use
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`in either the same field or a different one based on design incentives, or (3)
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`obvious to try.
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`Boston admits that the desire for uniform stent crimping was well-known at
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`the time of the invention. Paper 15 at 36. Boston ignores, however, that it was
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`also well-known to use ordinary pliers and other plier-like tools to crimp stents.
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`Ex. 1105 ¶ 87; Ex. 1127 ¶ 79. Although this common practice was well-known to
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`Boston and Dr. Solar, both failed to mention it or take it into account. Ex. 1126 at
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`73:17-76:17. This common practice provides ample reason for a POSITA to
`
`consider other plier-like tools for crimping stents. Ex. 1105 ¶¶ 81-88; Ex. 1127 ¶
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`80.
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`Yasumi is one such plier-like tool that a POSITA would have recognized as
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`suitable for crimping objects, including stents. Ex. 1105 ¶¶ 155-60; Ex. 1127 ¶ 54-
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`77. Yasumi discloses a press tool that uses a polygonal aperture configured to
`
`reduce in size without changing the aperture shape or orientation, thus applying
`
`uniform compression. A POSITA would have had a reasonable expectation of
`
`success using Yasumi’s uniform compression to provide the sought-after uniform
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`19
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`
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`
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`crimping forces beneficial in stent crimping. See In re Kubin, 561 F.3d 1351, 1360
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`(Fed. Cir. 2009) (reasonable expectation of success does not require that a POSITA
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`know with absolute predictability that an adaptation or combination would work).
`
`Yasumi is a straight-forward mechanical device; there is no “unpredictability” in
`
`how the device will behave. A POSITA would have had confidence that the
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`Yasumi press tool would operate as described in the specification. A POSITA
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`armed with knowledge of Yasumi and the need for uniform stent crimping would
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`have found it obvious to apply the teachings of Yasumi to a stent crimper. Ex.
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`1127 ¶ 81; Ex. 1105 ¶¶ 81-92, 155-60.
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`Boston criticizes the relevance of Yasumi by repeatedly characterizing it as
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`“an industrial tool for shaping and aligning an electric wire.” Paper 15 at 2; see
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`also id. at 25, 30.3 This is an incorrect and overly-narrow characterization of
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`Yasumi, which discloses multiple uses including, among others, a drawing die, a
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`chuck, a press tool, and a control valve. Ex. 1103 at 1:8-14, 1:35-40; Ex. 1127 ¶¶
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`17-19, 69-69. Yasumi is d
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