Patent Owner’s Response
`IPR2017-00444
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP.,
`
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-00444
`Patent 6,915,560
`_______________
`
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and STACY B.
`MARGOLIES, Administrative Patent Judges.
`
`PATENT OWNER’S RESPONSE
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`IPR2017-00444
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP.,
`
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-00444
`Patent 6,915,560
`_______________
`
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and STACY B.
`MARGOLIES, Administrative Patent Judges.
`
`PATENT OWNER’S RESPONSE
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`TABLE OF CONTENTS
`
`Patent Owner’s Response
`IPR2017-00444
`
`Page
`
`PATENT OWNER’S LIST OF EXHIBITS ..............................................................v
`
`I.
`
`II.
`
`STATEMENT OF RELIEF REQUESTED ....................................................1
`
`INTRODUCTION ...........................................................................................1
`
`III. BACKGROUND .............................................................................................3
`
`A.
`
`B.
`
`C.
`
`The ’560 Patent .....................................................................................4
`
`The Petitions..........................................................................................8
`
`The Art Upon Which Inter Partes Review Is Instituted .....................10
`
`1.
`
`2.
`
`Yasumi ......................................................................................10
`
`Morales......................................................................................12
`
`IV.
`
`V.
`
`THE OPINIONS OF PETITIONER’S EXPERT ARE
`ENTITLED TO LITTLE OR NO WEIGHT.................................................13
`
`THE CLAIM PREAMBLE “A STENT CRIMPER” IS
`LIMITING .....................................................................................................17
`
`VI. GROUND 1: CLAIMS 1, 2, 6, 8-11, 14, 15, 17-19, 23, 25-28,
`31, 33-35, 37, 39, AND 40 ARE NOT UNPATENTABLE IN
`VIEW OF FIGURE 8 OF YASUMI .............................................................24
`
`A.
`
`Yasumi Does Not Disclose Each Element of The
`Challenged Claims ..............................................................................24
`
`1.
`
`2.
`
`3.
`
`Yasumi Does Not Disclose A “Stent Crimper”........................25
`
`Yasumi Does Not Disclose Dies “Operatively
`Engaged” To A Stationary End-Wall .......................................25
`
`Yasumi Does Not Disclose Dies That Move
`“Inward” Or “Outward” To Change The Size Of
`The Aperture .............................................................................27
`
`i
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`B.
`
`C.
`
`A Skilled Artisan Would Not Have Considered The
`Figure 8 Embodiment Of Yasumi A Stent Crimper Or
`Been Motivated To Modify It To Crimp A Stent ...............................29
`
`Even If A Skilled Artisan Tried To Modify The Figure 8
`Embodiment Of Yasumi, They Would Not Have Had A
`Reasonable Expectation Of Success ...................................................33
`
`VII. GROUND 2: CLAIMS 11, 17, 19, 26, 34, 35, AND 39 ARE
`NOT UNPATENTABLE IN VIEW OF YASUMI FIGURE 8
`AND MORALES...........................................................................................34
`
`A.
`
`B.
`
`Yasumi In View Of Morales Does Not Disclose Each
`Element Of Claim 11, 17, 19, 26, 34, And 35.....................................34
`
`There Would Have Been No Motivation To Combine
`Yasumi with Morales ..........................................................................34
`
`VIII. OBJECTIVE INDICIA OF NON-OBVIOUSNESS
`ESTABLISH THAT THE CHALLENGED CLAIMS ARE
`NOT INVALID .............................................................................................35
`
`A.
`
`B.
`
`C.
`
`There Is A Nexus Between The Commercial Success Of
`Petitioner’s Crimpers And The Merits Of The Claimed
`Invention Of The ’560 Patent..............................................................35
`
`Petitioner Admits That There Was A Long-Felt And
`Unresolved Need For Uniformly Crimping A Stent...........................36
`
`Petitioner Admits Failure Of Others To Solve The Need
`For Uniformly Crimping A Stent........................................................36
`
`IX. CONCLUSION..............................................................................................37
`
`-ii-
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`TABLE OF AUTHORITIES
`
`CASES
`Apple Inc. v. Samsung Electronics Co., Ltd.,
`839 F.3d 1034 (Fed. Cir. 2016) .....................................................................32
`
`Page(s)
`
`Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) .......................................................................18
`
`Circuit Check Inc. v. QXQ Inc.,
`795 F.3d 1331 (Fed. Cir. 2015) .....................................................................32
`
`Corning Glass Works v. Sumitomo Elec. U.S.A., Inc.,
`868 F.2d 1251 (Fed. Cir. 1989) ...................................................15, 16, 17, 18
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litigation,
`676 F.3d 1063 (Fed. Cir. 2012) .....................................................................32
`
`Deere & Co. v. Bush Hog, LLC,
`703 F.3d 1349 (Fed. Cir. 2012) ...............................................................17, 18
`
`Gen. Elec. Co. v. Nintendo Co., Ltd.,
`179 F.3d 1350 (Fed. Cir. 1999) .........................................................16, 17, 18
`
`Karsten Mfg. Corp. v. Cleveland Golf Co.,
`242 F.3d 1376 (Fed. Cir. 2001) ...............................................................16, 18
`
`Oil States Energy Services, LLC v. Greene’s Energy Group, LLC,
`137 S. Ct. 2239 (2017).....................................................................................1
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .....................................................................20
`
`Poly-America, L.P. v. GSE Lining Tech., Inc.,
`383 F.3d 1303 (Fed. Cir. 2004) ...............................................................16, 18
`
`Regents of Univ. of Minn. v. AGA Med. Corp.,
`717 F.3d 929 (Fed. Cir. 2013) .......................................................................19
`
`iii
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`Rexnord Corp. v. Laitram Corp.,
`274 F.3d 1336 (Fed. Cir. 2001) .....................................................................19
`
`DOCKETED CASES
`Bio-Rad Labs., Inc. v. GE Healthcare Bio-sciences AB,
`IPR2015-01826, Paper 39 (P.T.A.B. Feb. 6, 2017) ......................................14
`
`CaptionCall, L.L.C. v. Ultratec, Inc.,
`IPR2015-00636, Paper 97 (P.T.A.B. Sept. 7, 2016) .....................................14
`
`Edwards Lifesciences Corp. v. Boston Scientific Scimed, Inc.,
`IPR2017-00072, Paper No. 1, Ex. 2015. (P.T.A.B. Oct. 13,
`2016) ............................................................................................................7, 8
`
`Microsoft Corp. v. Secure Web Conference Corp.,
`IPR2014-00745 (P.T.A.B. Sept. 29, 2014)....................................................28
`
`Owens Corning v. Fast Felt Corp.,
`IPR2015-00650, Paper 32 (P.T.A.B. Aug. 11, 2016)....................................14
`
`TCL Corp. v. Telefonaktiebolaget LM Ericsson,
`IPR2015-01674, Paper 35 (P.T.A.B. Feb. 13, 2017) ....................................14
`
`STATUTES
`
`37 C.F.R. § 42.65(a).................................................................................................14
`
`37 C.F.R. § 42.120 .....................................................................................................1
`
`35 U.S.C. § 103(a) .....................................................................................................8
`
`35 U.S.C. § 325(d) .....................................................................................................7
`
`-iv-
`
`
`
`PATENT OWNER’S LIST OF EXHIBITS
`
`Description
`
`Exhibit
`No.
`
`Patent Owner’s Response
`IPR2017-00444
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`Handbook of Coronary Stents, 2000 Ed.
`
`U.S. Patent No. 5,437,083 to Williams et al.
`
`U.S. Patent No. 5,626,604 to Cottone, Jr.
`
`U.S. Patent No. 5,725,519 to Penner et al.
`
`U.S. Patent No. 5,746,764 to Green et al.
`
`U.S. Patent No. 5,810,873 to Morales
`
`U.S. Patent No. 6,051,002 to Morales
`
`U.S. Patent No. 5,951,540 to Verbeek
`
`U.S. Patent No. 6,364,870 to Pinchasik
`
`File History Of U.S. Patent No. 6,360,577
`
`Boston Scientific’s Interrogatory Responses served on August 4, 2016
`
`September 30, 2016 Letter From Wallace Wu to Brian Horne
`
`U.S. Patent No. 6,360,577 to Austin
`
`U.S. Patent No. 6,823,576 to Austin
`
`Petition for Inter Partes Review of U.S. Patent No. 6,915,560, Case
`No. IPR2017-00072
`
`Declaration of Ronald J. Solar, Ph.D. (including Appendices A-D)
`
`September 14, 2017 Deposition Transcript of Neil Sheehan
`
`Neil Sheehan :: JurisPro Expert Witness Directory :: California
`(https://www.jurispro.com/expert/neil-sheehan-249)
`
`v
`
`
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`Patent Owner’s Response
`IPR2017-00444
`Neil Sheehan, Consulting Engineer _ Biomedical Engineering &
`Medical Devices (https://www.lexvisio.com/expert-witness/neil-
`sheehan-consulting-engineer)
`
`Neil Sheehan MEDICINE & HEALTH - Medic Expert Witness
`(http://www.morelaw.com/experts/expert.asp?f=Neil&l=Sheehan&i=3
`2263&z=94027&s=CA)
`
`U.S. Patent No. 5,810,838 to Solar
`
`U.S. Patent No. 5,971,992 to Solar
`
`Coronary Stenting Current Perspectives, Chapter 1, Historical
`Overview (1999)
`
`Boston Scientific Corporation’s and Boston Scientific Scimed, Inc.’s
`Supplemental Objections and Responses to Edwards’s Interrogatory
`Nos. 1-16 served on August 25, 2017
`
`U.S. Patent No. 5,836,952 to Davis et al.
`
`U.S. Patent No. 5,920,975 to Morales
`
`U.S. Patent No. 5,992,000 to Humphrey et al.
`
`U.S. Patent No. 6,096,027 to Layne
`
`U.S. Patent No. 6,361,637 to Martin et al.
`
`U.S. Patent No. 5,776,162 to Kleshinski
`
`Edwards Lifesciences Reports Second Quarter Results
`(http://www.edwards.com/ns20170726)
`
`Instructions For Use For Edwards Sapien 3
`
`U.S. Patent No. 7,530,253 to Spenser et al.
`
`U.S. Patent Publication No. US2009/0093876 to Nitzan et al.
`
`U.S. Patent Publication No. US2013/0310929 to Dove et al.
`
`U.S. Patent No. 7,895,876 to Spenser et al.
`
`vi
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
`
`U.S. Patent No. 5,672,169 to Verbeek
`
`U.S. Patent No. 5,911,752 to Dustrude et al.
`
`U.S. Patent No. 5,911,452 to Yan
`
`U.S. Patent No. 5,860,966 to Tower
`
`U.S. Patent No. 5,972,016 to Morales
`
`U.S. Patent No. 6,167,605 to Morales
`
`U.S. Patent No. 5,931,851 to Morales
`
`U.S. Patent No. 5,972,028 to Rabenau et al.
`
`U.S. Patent No. 6,024,737 to Morales
`
`U.S. Patent No. 6,082,990 to Jackson et al.
`
`U.S. Patent No. 6,202,272 to Jackson
`
`U.S. Patent No. 6,009,614 to Morales
`
`U.S. Patent No. 6,141,855 to Morales
`
`U.S. Patent No. 5,974,652 to Kimes et al.
`
`U.S. Patent No. 6,092,273 to Villareal
`
`vii
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`I.
`
`STATEMENT OF RELIEF REQUESTED
`On December 7, 2016, Edwards Lifesciences Corporation (“Petitioner”)
`
`submitted a Petition for Inter Partes Review (the “Petition” or “Pet.”) challenging
`
`claims 1, 2, 6, 8-11, 14, 15, 17-19, 23, 25-28, 31, 33-35, 37, 39, and 40 of U.S.
`
`Patent No. 6,915,560 (“the ’560 patent”). On June 29, 2017, the Patent Trials and
`
`Appeal Board (the “Board”) instituted Inter Partes Review of all challenged claims
`
`on two of the six grounds asserted in the Petition. Pursuant to 37 C.F.R. § 42.120,
`
`Boston Scientific Scimed, Inc. (“Patent Owner”) submits this Response to the
`
`Petition. As shown herein, Petitioner has failed to carry its burden of proving by a
`preponderance of the evidence that the challenged claims are unpatentable.1
`Patent Owner submits herewith the declaration of Ronald J. Solar, Ph.D., an
`
`engineer with extensive experience in the development of stents and stent
`
`crimpers.
`
`II.
`
`INTRODUCTION
`The inventor of the ’560 patent discovered an Iris-like device with a unique
`
`blade shape, connectivity, and movement design that would be remarkably
`
`1 Patent Owner reserves the right to argue that, in the event that Federal Circuit
`precedent is overturned and the Supreme Court determines that the Board lacks the
`authority to invalidate patents in Oil States Energy Services, LLC v. Greene’s
`Energy Group, LLC, 137 S. Ct. 2239 (2017), the decision in Oil States applies to
`
`the present proceeding.
`
`1
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`effective in uniformly crimping a stent (i.e., reducing the diameter of a stent). The
`
`invention solved the long-standing problem of uneven stent crimping.
`Petitioner’s primary obviousness reference (“Yasumi”) discloses an
`industrial tool for shaping and aligning an electric wire that lacks many elements
`
`required in the challenged claims of the ’560 patent. There is no suggestion
`
`whatsoever in Yasumi that the industrial tool could be used in a medical
`
`application, let alone as a stent crimper. Indeed, the disclosure of Yasumi is so
`
`deficient that it calls into question whether it would work even for its expressly
`
`intended purpose. Not surprisingly, in 30 U.S. patents on stent crimping filed after
`
`the issuance of Yasumi and before the filing of the ’560 patent, no one had ever
`
`mentioned using Yasumi for stent crimping purposes.
`
`Apparently recognizing these fatal deficiencies in its obviousness position,
`
`Petitioner resorts to the opinions of a professional expert, Mr. Neil Sheehan. Mr.
`
`Sheehan, however, merely repeats Petitioner’s arguments nearly verbatim—
`
`without citing any documents that support his opinions. During his deposition, it
`
`was revealed that Mr. Sheehan has no experience in stents or stent crimping; in
`fact, he has never crimped a stent. In absence of any evidentiary support or
`
`relevant experience, Mr. Sheehan’s opinions lack probative value.
`
`There are also strong objective indicia of the non-obviousness of the claimed
`
`inventions of the ’560 patent. Specifically, in its Petition, Petitioner admits the
`
`long-felt need for and the failure of others to achieve uniform stent crimping.
`
`For these reasons, as discussed in more detail below, the claimed inventions
`
`of the ’560 patent are not unpatentable.
`
`2
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`III. BACKGROUND
`A stent is a mesh-like tube that is placed in a body lumen to keep the lumen
`
`open. (Ex. 1101 at 1:25-31; Ex. 2016 at ¶ 23.) A stent may be delivered to the
`body lumen by mounting it on a balloon catheter. (Id.) Once the stent is delivered
`
`to the treatment site, it is expanded to the diameter of the lumen by the expansion
`
`of the balloon; the balloon catheter is thereafter withdrawn from the lumen. (Id.)
`
`The ’560 patent relates to an apparatus for crimping a stent so that it could be
`
`tightly mounted on a balloon catheter. (Ex. 1101 at 2:36-38.)
`
`The first successful human procedure using a balloon catheter to deliver a
`
`stent occurred in the late 1980s. (Ex. 2016 at ¶ 24.) At its early stages, stents were
`
`hand-crimped onto balloon catheters by physicians or clinicians, which “often
`
`result[ed] in the application of undesired uneven forces to the stent.” (Ex. 1101
`
`at 48-50.) It was (and still is) critically important to minimize distortion of the
`
`stent during the crimping process to ensure secure retention of the stent on the
`
`balloon catheter. (Id. at 1:38-43.) A poorly crimped stent may slip and be either
`lost in the body or deployed in the wrong location. (Id. at 1:44-45.) A poorly
`
`crimped stent can also cause abrasion or trauma to vessel walls and damage the
`
`balloon on which it is mounted. (Id. at 1:44-47.)
`
`Since the early 1990s, many medical device companies in the stent field
`
`devoted considerable resources in developing methods and devices for uniformly
`
`crimping a stent. (Ex. 2016 at ¶¶ 81-82, Appendix D.) Among those companies
`
`was Patent Owner (including its predecessor Scimed Life Systems, Inc.), which,
`
`since the 1990s, introduced a series of innovative and successful stent products
`
`3
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`crimped on balloon catheters (such as the NIR , Express, Taxus, Liberte, Promus,
`
`and Synergy products). (Ex. 2101 at 281-293; Ex. 2016 at ¶ 25.)
`
`The ’560 Patent
`A.
`Claiming priority to a September 22, 1999 patent application, the ’560 patent
`
`relates to an innovative Iris-like stent crimper. It adopts a unique design of blade
`
`shape, connectivity, and movement that applies even forces to the stent while
`
`minimizing the distortion of the stent. (Ex. 1101 at 2:26-29, 2:56-65.) An
`
`exemplary stent crimper design is shown in Figure 4A of the ’560 patent:
`
`In Figure 4A, the stent crimper comprises eight coupled blades 106 (orange)
`
`disposed about a reference circle 114 (green) to form an aperture 118, in which the
`
`4
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`stent is disposed. (Id. at 4:64-5:12, 5:46-62.) Each blade 106 includes a radial
`
`point 122 (yellow), which lies on a radial line 126 (blue) of the reference circle
`
`114.
`
`One of the unique features of the stent crimpers of the ’560 patent is that
`
`each blade (106) may move only in a direction parallel to the radial line 126. (Id.
`
`at 4:66-5:3.) This linear motion of the blades is effectuated by the rotation of the
`actuation plate. (Id. at 5:46-47 (“[T]he clockwise motion of the actuation plate is
`translated into linear motion of” each blade) (emphasis added).) Thus, when all
`
`the blades move simultaneously inward (via a linear motion), the aperture closes.
`(Id. at 5:46-62.) Conversely, when all the blades move simultaneously outward
`
`(via a linear motion), the aperture opens. (Id.)
`
`Another feature of the claimed inventions of the ’560 patent is the presence
`
`of multiple stationary plates enclosing the blades. For example, Figure 8a depicts
`
`two stationary plates 156 (green) surrounding the blades 106 of a stent crimper:
`
`5
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`A stationary plate can be operatively engaged with the blades at distinct connection
`locations. (Id. at 7:16-21 (“The presence of the second non-rotating plate 156b,
`
`linear slide 154b and connecting link 130b is optional but contributes to providing
`
`a rigid frame upon which the connecting links and associated slides may slide
`
`without misalignment relative to the reference circle.”).)
`
`Claims 1, 10, and 39 of the ’560 patent are representative independent
`
`claims among the challenged claims. They read as follows, with the relevant
`
`features of the claimed inventions highlighted in bold:
`
`1. A stent crimper comprising:
`a plurality of movable dies arranged to form an iris having a
`longitudinal axis, the iris defining an aperture, the dies disposed
`about the aperture and between stationary end-walls which are
`
`6
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`disposed about the longitudinal axis, at least one of the stationary
`end-walls operatively engaged to the dies at distinct connection
`locations such that the number of distinct connection locations and
`the number of dies are the same;
`each die having a first straight side and a second straight side, the first
`straight side and the second straight side conver[g]ing to form a
`tip; wherein a portion of the first straight side of each die faces the
`aperture, each first straight side parallel to the second side of an
`adjacent die.
`
`10. A stent crimper comprising:
`a plurality of movable dies arranged to form an iris, the dies disposed
`about an aperture, the aperture having a longitudinal axis and a
`substantially regular polygonal shape, each of the dies having an
`inward facing straight side which faces the longitudinal axis of the
`aperture, both when the dies move to maximize the aperture and
`when the dies move to minimize the aperture, the dies between two
`stationary end-walls disposed about the longitudinal axis, the
`longitudinal axis passing through a point substantially centered on
`the end-walls,
`a rotatable actuation device coupled to the dies, rotation of the
`actuation device causing the inward facing straight sides of the
`dies to move inward and reduce the size of the aperture or outward
`so as to increase the size of the aperture.
`
`39. A stent crimper comprising:
`a plurality of movable dies arranged to form an iris disposed about an
`
`7
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`aperture, the aperture having a center and a first opening and a
`second opening, the dies constructed and arranged to have a length
`exceeding the length of a stent with a longitudinal axis passing
`through both the first opening and the second opening, each die in
`communication with an actuation device, the actuation device
`constructed and arranged such that rotational motion of the
`actuation device opens or closes the aperture; each die having a
`first straight side and a second straight side, the first straight side
`and the second straight side converging to form a tip; wherein a
`portion of the first straight side of each die faces the aperture, each
`first straight side parallel to the second side of an adjacent die.
`
`The Petitions
`B.
`On April 19, 2016, Patent Owner brought suit in the U.S. District Court for
`
`the Central District of California against Petitioner alleging, inter alia, that
`
`Petitioner’s crimpers infringe the ’560 patent. See Boston Scientific Corp. et al. v.
`Edwards Lifesciences Corp., No. 8:16-cv-00730 (C.D. Cal.). On October 14,
`
`2016, Petitioner filed its first Inter Partes Review petition against claims 1, 2, 6, 8-
`
`11, 14, 15, 17-19, 23, 25-28, 31, 33-35, 37, 39, and 40 of the ’560 patent, asserting
`four grounds of invalidity (the “First Petition”). (Edwards Lifesciences Corp. v.
`
`Boston Scientific Scimed, Inc., IPR2017-00072, Paper No. 1, Ex. 2015.) Patent
`
`Owner submitted its preliminary response to the First Petition on January 25, 2017.
`
`(IPR2017-00072, Paper No. 7.) On April 21, 2017, the Board denied institution of
`
`the First Petition, in its entirety, under 35 U.S.C. § 325(d). (IPR2017-00072, Paper
`
`8.) Specifically, the Board held that the alleged Applicant Admitted Prior Art and
`
`8
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`Morales were previously previous presented to the Office and that Petitioner’s
`
`other arguments are the same or substantially the same as those already considered
`
`during the prosecution of the ‘560 patent. (Id. at 11.) On May 22, 2017, Petitioner
`
`filed a motion for reconsideration, which the Board denied on September 5, 2017.
`
`(IPR2017-00072, Paper 10.)
`
`On December 7, 2016, Petitioner filed a second Petition (the “Second
`
`Petition”) against the same challenged claims of the ’560 patent. On April 4, 2017,
`
`Patent Owner filed its preliminary response to the Second Petition. On June 29,
`
`2017, the Board instituted Inter Partes Review of the ’560 patent on two of the six
`
`asserted grounds of unpatentability, as set forth below:
`
`(1)
`
`(2)
`
`Claims 1, 2, 6, 8-11, 14, 15, 17-19, 23, 25-28, 31, 33-35, 37, 39,
`and 40 as obvious over Yasumi, as taught in the embodiment of
`Figure 8, under 35 U.S.C. § 103(a); and
`
`Claims 11, 17, 19, 26, 34, 35, and 39 as obvious over Yasumi,
`as taught in the embodiment of Figure 8, and Morales under 35
`U.S.C. § 103(a).
`
`(Paper 9 at 25.) With respect to other asserted grounds, the Board held that
`
`Petitioner fails to provide any explanation of the relationship between Figure 8 and
`
`Figure 9(a) of Yasumi and that certain other grounds are duplicative to the two
`
`instituted grounds. (Id. at 8, 23-24.) Patent Owner hereby submits its Response to
`
`the Second Petition with respect to the instituted two grounds.
`
`9
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`On April 19, 2017, Petitioner filed a third Petition (the “Third Petition”)
`
`against the same challenged claims of the ’560 patent. (Edwards Lifesciences
`
`Corp. v. Boston Scientific Scimed, Inc., IPR2017-01301, Paper 1.) On August 9,
`
`2017, Patent Owner submitted its preliminary response to the Third Petition.
`
`(IPR2017-01301, Paper 6.) As of this filing, the Board has not determined whether
`
`to institute the Third Petition.
`
`C.
`
`The Art Upon Which Inter Partes Review Is Instituted
`1.
`Yasumi
`Yasumi claims priority to an application filed in July 1980. It sought to
`
`solve a then-existing problem relating to a guide device having a conical, unitary
`
`structure that was used for guiding an electrical wire into a predetermined position;
`
`previously, such a task required one to locate and use a guide device having a size
`
`that corresponded to the thickness of the electrical wire. (Ex. 1103 at 1:14-21.)
`
`Yasumi also sought to solve a problem relating to a chuck having three or four
`
`clicks, which was used for clamping an article; previously, the articles to be
`
`clamped could get between clicks, depending on the size of the article, resulting in
`
`a state in which an axis of the article was not in agreement with an axis of the
`chuck. (Id. at 1:21-31.) Yasumi purports to address those problems by way of an
`
`“aperture setting device.”
`
`Figure 3 of Yasumi depicts the “principles of the aperture setting device”
`disclosed in the Figure 8 embodiment of Yasumi. (Id. at 5:39-40.) Such aperture
`
`setting device includes movable pieces 12 to 19 disposed in a frame 20, such that
`
`the movable pieces form an aperture 11. Each movable piece 12 to 19 includes an
`
`10
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`integrally formed elongated projection 40 that moves within a guide groove 39 of
`
`the frame 20. The movable pieces 12 to 19 and frame 20 are mounted on a guide
`
`base 21 having drive pins 22-1 to 22-8, each drive pin 22-1 to 22-8 inserted into an
`
`elongated hole 23-1 to 23-8 of a movable piece 12 to 19. When the guide base 21
`
`turns relative to the frame 20, the projections 40 move along the guide grooves 39,
`
`such that the aperture 11 increases or decreases in size. (Id. at 5:39-6:8.)
`
`Figure 8 of Yasumi incorporates the aperture setting device depicted in
`Figure 3 into a “manual forming and pressing tool.” (Id. at 7:33-35.) The tool
`
`includes a fixed handle 26 composed of parallel side plates 27-1 and 27-2. A
`
`movable handle 37 includes a frame 20, in which movable pieces 12 to 17 are
`
`disposed. The tool further includes a setting piece 32. Drive pins 45 and screws
`
`46 pass through holes 36-31 to 36-36, 36-21 to 36-26, and 36-11 to 36-16 in
`
`support discs 42 and 43, and the setting tool 32, as well as through elongated holes
`
`11
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`23-1 to 23-6 in the movable pieces 12 to 17. While (1) the size of the aperture
`
`purportedly changes when the movable handle 37 and fixed handle 26 are moved
`
`toward or away from each other and (2) the setting piece 32 can be used in
`
`conjunction with an adjust disc 30 to set a desired aperture size (Ex. 1103 at 9:7-
`
`15), the Figure 8 embodiment does not contain sufficient detail to teach a person of
`
`ordinary skill in the art how these features actually work together, if they do.
`
`(Ex. 2016 at ¶¶ 38-40.)
`
`2. Morales
`Morales, filed in 1998, relates to a tool for crimping a stent onto a balloon
`
`catheter. Petitioner relies on Morales only to the extent that it discloses a stent
`
`12
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`disposed about a medical balloon on a catheter, and that the tool is capable of
`
`accommodating the entire length of a stent. (Pet. at 89-90.)
`
`IV. THE OPINIONS OF PETITIONER’S EXPERT ARE ENTITLED TO
`LITTLE OR NO WEIGHT
`The declaration of Petitioner’s expert, Neil Sheehan, is entitled to little or no
`
`weight because he lacks experience in the relevant technologies. While Mr.
`
`Sheehan claims to have “over 40 years of experience in medical device design and
`
`development” (Ex. 1105 at ¶ 5), he readily admits that he has never developed a
`
`stent:
`
`Q: Now, have you designed any stents in your career?
`
`A: Have I designed a stent? I think the answer is no. . . .
`
`(Ex. 2017 at 81:15-18.)
`
`Q: Have you been on a patent that’s directed to a stent?
`
`A: No.
`
`(Id. at 82:3-9.) He has no relevant publications:
`
`Q: Looking at your resume, you didn’t list any publications.
`Have you had any publications in a peer-reviewed journal?
`
`A: No.
`
`Q: Have you authored, co-authored, any books or book
`chapters?
`
`A: No.
`
`(Id. at 81:7-14.)
`
`13
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`Nor does Mr. Sheehan have any relevant experience in stent crimping, the
`
`subject matter of the ‘560 patent:
`
`Q: Have you ever designed a stent crimper in your career?
`
`A: No.
`
`Q: Have you ever built a stent crimper in your career?
`
`A: No. . . .
`
`(Id. at 66:21-67:3.) In fact, Mr. Sheehan has never crimped a stent:
`
`Q: … Have you been on, an inventor of a patent that’s directed
`to a stent crimper?
`
`A: No.
`
`Q: When was the last time that you used a pressing tool to
`crimp a stent?
`
`A: Oh, to crimp a stent.
`
`Q: Yes.
`
`A. For me crimping a stent?
`
`Q: Yeah.
`
`A: No, I don’t think I’ve ever had to -- well, let’s think about
`this. Crimp a stent. I think the answer is I haven’t. . . . .
`
`14
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`(Id. at 83:24-84:7 (emphasis added).)2
`By contrast, Patent Owner’s expert, Dr. Solar, has extensive expertise in
`
`stents and stent crimpers. At least 20 of Dr. Solar’s patents, publications, and
`
`presentations specifically relate to stents or stent crimpers. In particular, Dr. Solar
`
`is the sole inventor of two U.S. patents—filed in March 1997, before filing date of
`
`the ’560 patent—directed to a stent crimper. (Exs. 2021, 2022.) The object of
`
`these patents is to provide a device “to facilitate the uniform crimping or
`
`compression of the stent … over the balloon of the delivery catheter” (Ex. 2021 at
`
`3:14-16), which is also the object of the ’560 patent.
`
`Thus, to the extent that there is any disagreement between Mr. Sheehan and
`
`Dr. Solar, the Board should give less or no weight to Mr. Sheehan’s opinions. See
`
`TCL Corp. v. Telefonaktiebolaget LM Ericsson, IPR2015-01674, Paper 35 at 36-37
`
`(P.T.A.B. Feb. 13, 2017) (crediting one party’s expert, who had experience
`
`working on technology in the prior art, over the other party’s expert); CaptionCall,
`
`L.L.C. v. Ultratec, Inc., IPR2015-00636, Paper 97 at 11 (P.T.A.B. Sept. 7, 2016)
`
`(holding that “to the extent [an expert] offers testimony outside her area of
`
`2 In reality, Mr. Sheehan is a professional expert, who advertises his expert service
`
`on multiple websites. (Exs. 2018, 2019, 2020.) He claims to have been retained as
`
`an expert about 120 times. (Ex. 2018 at 2.) From 2014 to 2016, one hundred
`
`percent of Mr. Sheehan’s income was derived from serving as an expert witness.
`
`(Ex. 2017 at 8:20-22, 9:13-17.)
`
`15
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`
`expertise, we have ‘broad discretion to accord those particular statements less
`
`weight’”); Bio-Rad Labs., Inc. v. GE Healthcare Bio-Sciences AB, IPR2015-
`
`01826, Paper 39 at 9 (P.T.A.B. Feb. 6, 2017) (“To the extent that [an expert] is
`
`more familiar with [one aspect of the relevant technology] and less familiar with
`
`[another], we weigh [his] testimony accordingly, taking into account the extent of
`
`his expertise in those areas.”); Owens Corning v. Fast Felt Corp., IPR2015-00650,
`
`Paper 32 at 24 (P.T.A.B. Aug. 11, 2016) (“to the extent an expert is familiar with
`
`one relevant field and not the other, we weigh the expert’s testimony accordingly,
`
`taking into account the extent of the expert’s expertise in the field”).
`
`Additionally, Mr. Sheehan’s declaration is entitled to little or no weight
`
`because he repeatedly relies on unsupported, conclusory assertions—rather than
`
`credible evidence—to support his opinions. See 37 C.F.R. § 42.65(a) (“Expert
`
`testimony that does not disclose the underlying facts or data on which the opinion
`
`is based is entitled to little or no weight”). For example, without any support or
`
`citation, Mr. Sheehan opines that “[a] POSITA would have readily understood that
`
`a press tool is a crimper, and therefore Yasumi is directed to a crimper” and “[a]
`
`POSITA would also have understood that the invention discussed in Yasumi could
`
`be used to crimp any object, including a stent.” (Ex. 1105 at ¶ 109.) Mr.
`
`Sheehan’s conclusory and unsupported opinions are particularly unreliable given
`
`his lack of experience with stents or stent crimpers and given that he has never
`
`even crimped a stent—using a press tool such as that disclosed in Yasumi or
`
`otherwise.
`
`16
`
`
`
`Patent Owner’s Response
`IPR2017-00444
`THE CLAIM PREAMBLE “A STENT CRIMPER” IS LIMITING
`When a preamble breathes “life and meaning” into a claim, it is a necessary
`
`V.
`
`limitation to the claim. Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868
`
`F.2d 1251, 1257 (Fed. Cir. 1989). In a long line of cases, the Federal Circuit has
`
`applied this principle to find claim preambles limiting. The same principle applies
`
`t
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
