UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`BOSTON SCIENTIFIC CORPORATION and
`BOSTON SCIENTIFIC SCIMED, INC.
`Petitioner
`
`v.
`
`VASCULAR SOLUTIONS, INC.
`Patent Owner
`
`________________
`
`Case IPR: Unassigned
`Patent 8,048,032
`
`________________
`
`Attorney Docket No. 0025216-00057
`
`________________
`
`PETITION FOR INTER PARTES REVIEW
`UNDER 37 C.F.R. § 42.100
`
`

`

`I.
`
`II.
`III.
`
`E.
`
`F.
`G.
`H.
`
`MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))......................................1
`A.
`Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) ....................................1
`B.
`Related Matters (37 C.F.R. § 42.8(b)(2))..............................................1
`C.
`Lead And Back-Up Counsel (37 C.F.R. §§ 42.8(b)(3), 42.10(a)) ........2
`D.
`Service Information (37 C.F.R. § 42.8(b)(4)) .......................................2
`PAYMENT OF FEES (37 C.F.R. § 42.103) ...................................................2
`HJCC6GL E< G;B;K6DI I;8>DEBE=L 6D9 o*-, F6I;DI .........3
`A.
`Overview Of Interventional Cardiology Procedures ............................3
`B.
`9SaQ‘W^bW]\ ET IVS 6ZZSUSR ?\dS\bW]\ ET IVS o*-, FObS\b..................4
`C.
`Hc[[O‘g ]T bVS F‘]aSQcbW]\ >Wab]‘g ]T bVS o*-, FObS\b ......................6
`IV. REQUIREMENTS FOR INTER PARTES REVIEW ....................................9
`A.
`Grounds for Standing Under 37 C.F.R. § 42.104(a).............................9
`B.
`Identification of Challenge and Relief Requested ..............................10
`Claims for Which Inter Partes Review Is Requested.........................10
`C.
`D.
`The Specific Art and Statutory Ground(s) on Which the Challenge
`Is Based Under 37 C.F.R. § 42.104(b)(2) ...........................................10
`Construction Of The Challenged Claims ............................................11
`1.
`m‘OWZ ab‘cQbc‘S eWbV]cb O Zc[S\n................................................12
`2.
`mW\bS‘dS\bW]\OZ QO‘RW]Z]Ug RSdWQS%a&n.......................................13
`3.
`mb] ‘SQSWdS O\ W\bS‘dS\bW]\OZ QO‘RW]Z]Ug RSdWQS W\b] bVe
`coaxial lumen while the proximal portion remains within the
`Zc[S\ ]T bVS UcWRS QObVSbS‘n ) mORO^bSR b] ‘SQSWdS O\
`interventional cardiology device passed through continuous
`lumen of the guide catheter and into the coaxial lumen while
`the device is insertSR W\b] bVS Q]\bW\c]ca Zc[S\n ....................14
`mORO^bSR b] PS SfbS\RSR PSg]\R bVS RWabOZ S\R ]T bVS UcWRS
`catheter while a proximal portion remains within the
`lumen of the guide catheter, such that the device assists in
`resisting axial and shear forces exerted by the
`interventional cardiology device passed through and
`beyond the coaxial lumen that would otherwise tend to
`dislodge the guide catVSbS‘ T‘][ bVS P‘O\QV O‘bS‘gn .............16
`Non-Redundancy of Proposed Alternative Grounds ..........................17
`Level of Skill In the Art ......................................................................20
`The Prior Art References.....................................................................20
`
`TABLE OF CONTENTS
`
`Page
`
`4.
`
`ii
`
`

`

`6RO[a o,3,...............................................................................21
`1.
`Klein..........................................................................................22
`2.
`6RO[a o./,...............................................................................22
`3.
`Steinke.......................................................................................23
`4.
`Takahashi ..................................................................................23
`5.
`How The Construed Claim(s) Are Unpatentable................................24
`I.
`SUPPORTING EVIDENCE UNDER 37 C.F.R. § 42.104(B)(5).................24
`V.
`VI. ANTICIPATION OF THE CHALLENGED CLAIMS................................24
`A.
`Claims 1, 2, 8, 11, And 17 Are Anticipated Under 35 U.S.C. §
`+*,%P& 7g 6RO[ap,3,.........................................................................25
`1.
`Claim 1......................................................................................25
`2.
`Claim 2......................................................................................27
`3.
`Claim 11....................................................................................27
`4.
`Claims 8 and 17.........................................................................27
`VII. OBVIOUSNESS OF CHALLENGED CLAIMS .........................................39
`A.
`Claims 1-4, 8, 11, 13 And 17 Are Obvious Under 35 U.S.C. § 103
`EdS‘ 6RO[a o,3, ?\ KWSe ET AZSW\ ...................................................40
`Claims 1-4, 8, 11, 13 And 17 Are Obvious Under 35 U.S.C. § 103
`EdS‘ 6RO[a o,3, ?\ KWSe ET 6RO[a o./, ........................................46
`Claims 1-4, 8, 11, 13 and 17 Are Obvious Under 35 U.S.C. § 103
`EdS‘ 6RO[a o,3, ?\ KWSe ET HbSW\YS................................................51
`Claims 8 And 17 Are Obvious Under 35 U.S.C. § 103 Over Adams
`o,3, ?\ KWSe ET IVS A\]eZSRUS ]T E\S ET HYWZZ ?\ IVS 6‘b............57
`Claims 1, 2. 8, 11 And 17 Are Obvious Under 35 U.S.C. § 103
`Over Adams In View Of Takahashi....................................................58
`VIII. CONCLUSION..............................................................................................60
`
`D.
`
`B.
`
`C.
`
`E.
`
`iii
`
`

`

`Exhibit List for Inter Partes Review of U.S. Patent No. 8,048,032
`
`Exhibit No.
`1001
`1002
`1003
`
`1004
`1005
`1006
`1007
`1008
`
`Exhibit Description
`U.S. Patent No. 8,048,032 to Root, et al.
`File History for U.S. Patent No. 8,048,032
`Declaration of Ronald Jay Solar, Ph.D., with attached Appendix1:
`Curriculum Vitae of Ronald Jay Solar, Ph.D. and attached Appendix
`2: Prior Expert Testimony of Ronald Jay Solar, Ph.D
`U.S. Patent No. 8,292,850 to Root, et al.
`U.S. Patent No. 8,142,413 to Root, et al.
`File History for U.S. Patent No. 8,292,850
`File History for U.S. Patent No. 8,142,413
`Copy of a Second Petition (excluding exhibits) for Inter Partes
`GSdWSe <WZSR 8]\Qc‘‘S\bZg Pg FSbWbW]\S‘ ]\ bVS o*-, FObS\b
`U.S. Publication No. 2004/0236215 A1 to Mihara et al.
`Translation of Japanese Patent Application No. 2003-070808
`U.S. Patent No. 5,527,292 to Adams et al.
`U.S. Publication No. 2003/0195546 A1 to Solar, et al.
`U.S. Patent No. 6,638,268 to Niazi
`U.S. Publication No. 2005/0004523 A1 to Osborne, et al.
`U.S. Publication No. 2004/0127927 to Adams
`U.S. Patent No. 6,338,725 B1 to Hermann et al.
`U.S. Patent No. 5,776,141 to Klein et al.
`U.S. Patent No. 7,232,452 to Adams et al.
`U.S. Patent No. 5,328,472 to Steinke et al.
`IOYOVOaVW Sb OZ(’ mDSe CSbV]R b] ?\Q‘SOaS O 7OQYc^ Hc^^]‘b ]T O 0
`<‘S\QV =cWRW\U 8]‘]\O‘g 8ObVSbS‘’n Catherization and
`Cardiovascular Interventions 63:452-456 (2004)
`1021
`U.S. Patent No. 5,690,613 to Verbeek
`1022
`U.S. Patent No. 5,156,594 to Keith
`1023
`U.S. Patent No. 5,102,403 to Alt
`Kucklick, Theodore R., The Medical Device R&D Handbook (2006) 1024
`Amended Complaint filed by Vascular Solutions, Inc. in Vascular
`1025
`Solutions, Inc. v. Boston Scientific Corporation, No. 13-cv-1172
`(JRT-SER) (D. Minn.) (May 28, 2013)
`Memorandum In Support of Motion for Preliminary Injunction filed
`by Vascular Solutions, Inc. in Vascular Solutions, Inc. v. Boston
`Scientific Corporation, No. 13-cv-1172 (JRT-SER) (D. Minn.)
`(June 10, 2013)
`
`1009
`1010
`1011
`1012
`1013
`1014
`1015
`1016
`1017
`1018
`1019
`1020
`
`1026
`
`iv
`
`

`

`9SQZO‘ObW]\ ]T >]eO‘R G]]b ?\ Hc^^]‘b ]T KOaQcZO‘ H]ZcbW]\’ ?\Q(pa
`Motion for Preliminary Injunction with Non-Confidential Exhibits
`filed in Vascular Solutions, Inc. v. Boston Scientific Corporation,
`No. 13-cv-1172 (JRT-SER) (D. Minn.) (June 10, 2013)
`Boston Scientific Corporation Opposition to Vascular Solutions,
`?\Q(pa C]bW]\ T]‘ F‘SZW[W\O‘g ?\Xc\QbW]\ TWZSR W\ Vascular Solutions,
`Inc. v. Boston Scientific Corporation, No. 13-cv-1172 (JRT-SER)
`(D. Minn.) (July 28, 2013)
`Non-Confidential Memorandum Opinion and Order Granting In Part
`FZOW\bWTTpa C]bW]\ T]‘ F‘SZW[W\O‘g ?\Xc\QbW]\ TWZSR W\ Vascular
`Solutions, Inc. v. Boston Scientific Corporation, No. 13-cv-1172
`(JRT-SER) (D. Minn.) (December 19, 2013)
`7]ab]\ HQWS\bWTWQ 8]‘^]‘ObW]\pa C]bW]\ T]‘ 6\ ?\bS‘W[ HbOg O\R
`Stay Pending Appeal, No. 2014-1185 (Fed. Cir.) filed December 27,
`2013
`KOaQcZO‘ H]ZcbW]\a’ ?\Q(pa Opposition to Boston Scientific
`8]‘^]‘ObW]\pa C]bW]\ T]‘ 6\ ?\bS‘W[ HbOg O\R HbOg FS\RW\U 6^^SOZ’
`No. 2014-1185 (Fed. Cir.) filed January 3, 2014
`7]ab]\ HQWS\bWTWQ 8]‘^]‘ObW]\pa D]\-Confidential Opening Brief,
`No. 2014-1185 (Fed. Cir.) filed January 7, 2014
`KOaQcZO‘ H]ZcbW]\a’ ?\Q(pa D]\-Confidential Responsive Brief, No.
`2014-1185 (Fed. Cir.) filed January 29, 2014
`7]ab]\ HQWS\bWTWQ 8]‘^]‘ObW]\pa GS^Zg 7‘WST’ D]( ,*+.-1185
`(Fed. Cir.) filed February 3, 2014
`Transcript of Oral Argument Proceedings held on April 8, 2014
`(Fed. Cir.)
`Federal Circuit Order Vacating Preliminary Injunction (April 15,
`2014)
`Joint Claim Construction Statement filed in Vascular Solutions, Inc.
`v. Boston Scientific Corporation, No. 13-cv-1172 (JRT-SER)
`(D. Minn.) (February 21, 2014)
`U.S. Patent No. 6,997,908 B2 to Carrillo, Jr., et al.
`Monorail Piccolino Publication, Introducing the Schneider
`MONORAIL-GEX# Guidewire Exchange Catheter Brochure
`U.S. Publication No. 2002/0165598 A1 to Wahr et al.
`U.S. Patent No. 5,267,958 to Buchbinder et al.
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`1039
`
`1040
`1041
`
`v
`
`

`

`Inter partes review is respectfully requested for claims 1-4, 8, 11, 13, and 17
`
`PRIVILEGED AND CONFIDENTIAL
`ATTORNEY WORK PRODUCT
`
`of U.S. Patent No. 8,048,032 %mbVS o*-, FObS\bn& %;fV( +**+&(
`
`7&
`
`MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
`
`The following mandatory notices are provided as part of this Petition.
`
`/&
`
`Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
`
`Boston Scientific Corporation and Boston Scientific Scimed,
`
`Inc.
`
`%Q]ZZSQbWdSZg mFSbWbW]\S‘n& O‘S bVS ‘SOZ ^O‘bWSa-in-interest.
`
`0&
`
`Related Matters (37 C.F.R. § 42.8(b)(2))
`
`IVS o*-, FObS\b Wa ^‘SaS\bZg bVe subject of litigation brought by the Patent
`
`Owner against Petitioner in the U.S. District Court for the District of Minnesota in
`
`a case titled Vascular Solutions, Inc. v. Boston Scientific Corp., No. 1:13-cv-1172
`
`(JRT/SER) (May 16, 2013). Petitioner is also seeking inter partes review of the
`
`o*-, FObS\b ]\ ]bVS‘ U‘]c\Ra W\ O\]bVS‘ ^SbWbW]\ b] PS TWZSR Q]\Qc‘‘S\bZg VS‘SeWbV(
`
`Further, Petitioner is filing two separate petitions on non-redundant grounds
`
`seeking inter partes review of U.S. Patent No. 8,292,8/* %bVS mo2/* ^ObS\bn& O\R
`
`one petition seeking review of U.S. Patent No. 2’+.,’.+- %bVS mo.+- ^ObS\bn %;fV(
`
`1005)) to be filed concurrently herewith.
`
`In all, five petitions will be filed.
`
`Petitioner requests that all of these petitions be assigned to the same Board for
`
`administrative efficiency, as all three patents are closely related and are directed
`
`US\S‘OZZg b] bVS aO[S acPXSQb [ObbS‘( H^SQWTWQOZZg’ bVS o2/* ^ObS\b %;fV( +**.& Wa O
`
`1
`
`

`

`RWdWaW]\ ]T O^^ZWQObW]\ D]( +,)2,.’1-.’ eVWQV WaacSR Oa bVS o.+- ^ObS\t (Exh.
`
`+**/&’ O\R bVS o.+- ^ObS\b Wa O RWdWaW]\ ]T O^^ZWQObW]\ D]( ++).+0’0,3’ eVWQV
`
`WaacSR Oa bVS o*-, ^ObS\b( IVS QZOW[a QVOZZS\USR bVS‘SW\ O‘S [SbV]R %o.+- ^ObS\b&
`
`O\R agabS[ %o2/* ^ObS\b& dS‘aW]\a ]T bVS O^^O‘Obca QZOW[a ]T bVS o*-, ^ObS\b
`
`challenged herein.
`
`1&
`
`Lead And Back-Up Counsel (37 C.F.R. §§ 42.8(b)(3), +)&(’#D$)
`
`Petitioners designate undersigned David R. Marsh (Reg. No. 41,408) of
`
`Arnold & Porter LLP as lead counsel and Kristan L. Lansbery (Reg. No. 53,183),
`
`also of Arnold & Porter LLP, as back-up counsel.
`
`Lead Counsel
`David R. Marsh (Reg. No. 41,408)
`ARNOLD & PORTER LLP
`555 Twelfth Street, NW
`Washington, DC 20004-1206
`Telephone: 202.942.5068
`Facsimile: 202.942.5999
`Email: david.marsh@aporter.com
`
`Back-Up Counsel
`Kristan L. Lansbery (Reg. No. 53,183)
`ARNOLD & PORTER LLP
`555 Twelfth Street, NW
`Washington, DC 20004-1206
`Telephone: 202.942.5186
`Facsimile: 202.942.5999
`Email: kristan.lansbery@aporter.com
`
`2&
`
`Service Information (37 C.F.R. § 42.8(b)(4))
`
`Petitioner consents to service by email
`
`to lead and backup counsel at
`
`xBSC_VSI_IPRService@aporter.com.
`
`77&
`
`=/C93;@ <4 433? #*- 1&4&>& Y +)&(’*$
`
`The undersigned authorizes the Office to charge Deposit Account No. 50-
`
`2387 the fee set forth in 37 C.F.R. § 42.15(a), or any other applicable fees, for this
`
`Petition for inter partes review. The undersigned further authorizes payment for
`
`2
`
`

`

`any additional fees that might be due in connection with this Petition to be charged
`
`to the above-referenced Deposit Account.
`
`777&
`
`SUMM/?C =4 ?393B/<A A316<=9=5C /<2 ](+* >/A3<A
`
`/&
`
`Overview Of Interventional Cardiology Procedures
`
`IVS QZOW[a ]T bVS o*-, ^ObS\b O‘S RW‘SQbSR b] bVS TWSZR ]T W\bS‘dS\bW]\OZ
`
`cardiology procedures, such as the treatment of obstructive coronary artery disease.
`
`(See Exh. 1001, 1:7-36.) During such procedures, physicians deploy thin, flexible
`
`treatment devices, such as guidewires, balloon catheters, filters, stents, stent
`
`catheters, or other devices to treat a blockage (occlusion) or narrowing (stenosis) in
`
`the arteries due to atherosclerotic plaques or other lesions. (Id.; see Declaration of
`
`G]\OZR @Og H]ZO‘’ FV(9( %mH]ZO‘ 9SQZO‘ObW]\n& (Exh. 1003, ¶ 8).) The physician
`
`W\b‘]RcQSa bVS b‘SOb[S\b RSdWQS W\b] bVS ^ObWS\bpa dOaQcZO‘ agabS[ bV‘]cUV bVS U‘]W\
`
`or wrist and advances it to the site of a blockage to perform a procedurelsuch as
`
`the inflation of a balloon or the placement of a stentlto relieve the blockage and
`
`restore blood flow. (Id.) Often, to create a passage for such treatment devices,
`
`^VgaWQWO\a W\aS‘b O mUcWRS QObVSbS‘n SO‘ZWS‘ W\ bVS ^‘]QSRc‘S( %Id.) In coronary
`
`interventions, this guide catheter typically runs from the groin or wrist to one of the
`
`coronary ostia (two openings in the aorta that open into the coronary arteries), but
`
`is too wide for advancement beyond the ostium. (Id(& IVS o*-, ^ObS\b Wa RW‘SQbSR b]
`
`an apparatus that is deliverable through a standard guide catheter for extension
`
`3
`
`

`

`beyond the ostium to provide back up supportli.e., to prevent the guide catheter
`
`from being dislodged during the procedure. (See, e.g., Exh. 1001, 2:45-49.)
`
`0&
`
`(3?1>7=@7<; ,4 /63 ’883532 *;B3;@7<; ,4 /63 D$&% -0@3;@
`
`IVS o*-, FObS\b %;fV( +**+& Q]\bOW\a ,, RSdWQS QZOW[a’ W\QZcRW\U be]
`
`W\RS^S\RS\b QZOW[a %QZOW[a + O\R ++&( IVS a^SQWTWQObW]\ ]T bVS o*-, ^ObS\b abObSa
`
`that Wb ‘SZObSa mUS\S‘OZZg b] QObVSbS‘a caSR W\ W\bS‘dS\bW]\OZ QO‘RW]Z]Ug ^‘]QSRc‘San
`
`O\R mM[N]‘S ^O‘bWQcZO‘Zg ((( O^^O‘Obca T]‘ W\Q‘SOaW\U POQYc^ ac^^]‘b T]‘ QObVSbS‘a
`
`W\aS‘bSR W\b] bVS Q]‘]\O‘g O‘bS‘WSa T‘][ bVS O]‘bO(n %;fV( +**+’ +41-11.)
`
`The challenged clOW[a ]T bVS o*-, ^ObS\b O‘S \]b ab‘OWUVbT]‘eO‘R( J\ZWYS
`
`bg^WQOZ O^^O‘Obca QZOW[a’
`
`bVS o*-, ^ObS\b QZOW[a O‘S ‘S^ZSbS eWbV Tc\QbW]\OZ
`
`language and ambiguous structural limitations that are unsupported by either the
`
`specification or knowledge in the art at the time of the claimed invention. Claim 1
`
`]T bVS o*-, ^ObS\b Wa ‘S^‘SaS\bObWdS ]T bVS W\RS^S\RS\b QZOW[a4
`
`1. A device for use with a standard guide catheter, the standard
`guide catheter having a continuous lumen extending for a predefined
`length from a proximal end at a hemostatic valve to a distal end
`adapted to be placed in a branch artery, the continuous lumen of the
`guide catheter having a circular cross-sectional inner diameter sized
`such that interventional cardiology devices are insertable into and
`through the lumen to the branch artery, the device comprising:
`a flexible tip portion defining a tubular structure having a circular
`cross-section and a length that is shorter than the predefined length of
`the continuous lumen of the guide catheter, the tubular structure
`
`4
`
`

`

`having a cross-sectional outer diameter sized to be insertable through
`the cross-sectional inner diameter of the continuous lumen of the
`guide catheter and defining a coaxial lumen having a cross-sectional
`inner diameter through which interventional cardiology devices are
`insertable; and
`a substantially rigid portion proximal of and operably connected to,
`and more rigid along a longitudinal axis than, the flexible tip portion
`and defining a rail structure without a lumen and having a maximal
`cross-sectional dimension at a proximal portion that is smaller than
`the cross-sectional outer diameter of the flexible tip portion and
`having a length that, when combined with the length of the flexible
`distal
`tip portion, defines a total
`length of the device along the
`longitudinal axis that is longer than the length of the continuous
`lumen of the guide catheter,
`such that when at least a distal portion of the flexible tip portion is
`extended distally of the distal end of the guide catheter, at least a
`portion of the proximal portion of the substantially rigid portion
`extends proximally through the hemostatic valve in common with
`interventional cardiology devices that are insertable into the guide
`catheter.
`(Id., claim 1.)
`
`9S^S\RS\b QZOW[ , ]T bVS o*-, ^ObS\b RS^S\Ra T‘][ W\RS^S\RS\b QZOW[ + O\R
`
`‘S_cW‘Sa mthat the device assists in resisting axial and shear forces exerted by the
`
`interventional cardiology device passed through and beyond the coaxial lumen that
`
`5
`
`

`

`e]cZR ]bVS‘eWaS bS\R b] RWaZ]RUS bVS UcWRS QObVSbS‘ T‘][ bVS P‘O\QV O‘bS‘g(n %Id.,
`
`claim 2.)
`
`Dependent claim 3 (depending from independent claim 1 and dependent
`
`claim 2), and dependent claim 13 (depending from independent claim 11), are
`
`RW‘SQbSR b] O m^‘]fW[OZ aWRS ]^S\W\U ((( SfbS\RW\U T]‘ O RWabO\QS OZ]\U bVS
`
`Z]\UWbcRW\OZ OfWan O\R mb‘O\adS‘aS Mi.e(’ Ob O\ O\UZSN b] bVS Z]\UWbcRW\OZ OfWa(n %Id.,
`
`claim 13.)
`
`Dependent claim 4 depends from claim - O\R ‘S_cW‘Sa O mab‘cQbc‘S RSTW\W\U O
`
`TcZZ QW‘Qc[TS‘S\QS ^]‘bW]\ O\R ab‘cQbc‘S RSTW\W\U O ^O‘bWOZZg QgZW\R‘WQOZ ^]‘bW]\’n Oa
`
`e]cZR ‘SacZb T‘][ O bcPS PSW\U aYWdSR Ob O\ O\UZS T]‘ ^O‘b ]T Wba ZS\UbV( IVSaS oaWRS
`
`o^S\W\U QZOW[ap O‘S RW‘SQbSR b] bVOb eVWQV eOa eSZZ Y\]e\ W\ bVS O‘b eVS\ bVS o*-,
`
`patent was filed: that the entryway to a lumen for the delivery of intravascular
`
`cardiology devices may be skived, or cut at an angle. (Id., claim 4.)
`
`Dependent claims 8 (depending from independent claim 1) and 17
`
`%RS^S\RW\U T‘][ W\RS^S\RS\b QZOW[ ++& ‘S_cW‘S bVOb mbVS Q‘]aa-sectional inner
`
`diameter of the coaxial lumen of the tubular structure is not more than one French
`
`smaller than the cross-sectional inner diameter of the UcWRS QObVSbS‘(n %Id., claim
`
`8.)
`
`1&
`
`.A990>C <4 @63 -><?31A@7<; )7?@<>C <4 @63 D$&% -0@3;@
`
`6
`
`

`

`IVS o*-, ^ObS\b eOa TWZSR Oa J(H( 6^^ZWQObW]\ HS‘WOZ D]( ++).+0’0,3 O\R
`
`issued on November 1, 2011. The original claims were restricted and the Applicant
`
`elected device claims. (Response to Restriction Requirement dated October 1,
`
`2008, at 11 (Exh. 1002, at 378).)
`
`Claims 1 and 12-15 were rejected as obvious over U.S. Patent 6,638,268
`
`%mDWOhWn& %;fV( +*+-& W\ dWSe ]T J(H( FObS\b 6^^ZWQObW]\ FcPZWQObW]\ D](
`
`2003/0195546 to H]ZO‘ %mH]ZO‘n& %;fV( +*+,&( 6QQ]‘RW\U b] bVS ;fO[W\S‘’ DWOhW
`
`RWaQZ]aSR OZZ Pcb mbVS SZ]\UObS ab‘cQbc‘S eWbV O acPabO\bWOZZg ‘WUWR ^]‘bW]\ ^‘]fW[OZ
`
`to the reinforced portion, including a cylindrical portion defining an opening along
`
`a side thereof, the opening extending at least a portion of the length of the rigid
`
`^]‘bW]\(n %;fV( +**,’ Ob -/+(& IVOb eVWQV eOa [WaaW\U T‘][ DWOhW eOa ^‘SaS\b W\
`
`H]ZO‘’ eVWQV RWaQZ]aSR mO\ SZ]\UObS RSdWQS Q][^‘WaW\U O ^caVW\U [S[PS‘ / O\R
`
`b‘OQYW\U [S[PS‘ 1 k(n %Id.) While the rejection refers to claims 9 and 12-15,
`
`claim 8 is specifically discussed and treated as rejected. (Exh. 1002, at 350.)
`
`Moreover, claims 9-11, 16, and 21 were rejected over the same combination
`
`and further in view of U.S. Patent Application Publication No. 2004/0127927 to
`
`Adams, et al(’ %m6RO[a o3,1n& %;fV( +*+/& O\R J(H( FObS\b 0’--2’1,/ b] >S‘[O\\’
`
`et al(’ %m>S‘[O\\n& %;fV( +*+0&( H^SQWTWQOZZg’ bVS ;fO[W\S‘ ]PaS‘dSR bVOb mH]ZO‘
`
`discloses a decreasing rigidity along the device as one travels distally. Adams
`
`discloses relief cuts as a method of forming a non-rigid bendable section in an
`
`7
`
`

`

`]bVS‘eWaS ab‘OWUVb [S[PS‘((((n %Exh. 1002, at 353.) The Examiner further noted
`
`bVOb m>S‘[O\\ RWaQZ]aSa O [SbOZ Q]WZ W[PSRRSR W\ O TZSfWPZS aVSObV b] Od]WR
`
`kinking and collapsS Rc‘W\U caS’n O\R mH]ZO‘ RWaQZ]aSa caW\U O UcWRSeW‘S 3 b] OZZ]e
`
`bVS agabS[ b] ORdO\QS SOaWZg b] O RSaW‘SR Z]QObW]\ eWbVW\ O ^ObWS\b$a P]Rg(n %Exh.
`
`1002, 353-354).)
`
`In an Office Action dated November 19, 2009, the Examiner maintained the
`
`rejection of then-claims 66, 69, and 74 (corresponding to claims 3 and 4 of the
`
`o*-, ^ObS\b& O\R OZa] QWbSR J(H( FObS\b D]( /’110’+.+ b] AZSW\’ et al(’ %mAZSW\n&
`
`(Exh. 1017.) Specifically, the Examiner observed that
`
`AZSW\ RWaQZ]aSa O k b‘OQYW\U [S[PS‘)aVSObV k bVOb Q]dS‘a O delivery
`catheter k( The sheath of Klein has a slant that gives it both fully
`cylindrical and partial cylindrical portions. Therefore, it would have
`been obvious to one of ordinary skill in the art at the time the
`invention was made to modify the elongate structure of Niazi with
`a k b‘OQYW\U [S[PS‘ %W\QZcRW\U bVS QgZW\R‘WQOZ aVO^S& Oa bOcUVb Pg
`
`AZSW\k(%;fV( +**,’ Ob ,1+& %S[^VOaWa ORRSR&(&
`Despite six attempts, multiple amendments, and an interview where the
`
`6^^ZWQO\bpa ‘S^‘SaS\bObWdS P‘]cUVb mO RSdWQS’n bhe revised claims remained
`
`rejected over Niazi in view of Solar until the final Examiner amendment. In
`
`addition, the claim amendments had resulted in additional rejections as the claims
`
`lacked written description for multiple negative limitations, including the genus
`
`m\]\-bcPcZO‘(n %Exh. 1002 at 185) and (Exh. 1002, at 142). Patentee attempted to
`
`8
`
`

`

`overcome the written description rejection by stating, without specific citation to
`
`bVS a^SQWTWQObW]\’ bVOb mMbNVS O^^ZWQObW]\ Oa TWZSR QZSO‘Zg RSaQ‘WPSa O\R RWTTSrentiates
`
`circular, cylindrical tubular shapes from those that are partially circumferential,
`
`non-circular or non-bcPcZO‘(n %Exh. 1002 at 125.) The application was allowed,
`
`V]eSdS‘’ ]\Zg OTbS‘ O\ ;fO[W\S‘pa O[S\R[S\b W\ eVWQV bVS ;fO[W\S‘ RSZSbSR
`
`m\]\-tubuZO‘n O\R acPabWbcbSR eWbV m‘OWZ ab‘cQbc‘S eWbV]cb O Zc[S\(n %Exh. 1002 at
`
`94.) E\Zg OTbS‘ bVS FObS\b Ee\S‘ OQQS^bSR bVS ;fO[W\S‘pa O[S\R[S\b’ ORRW\U m‘OWZ
`
`ab‘cQbc‘S eWbV]cb O Zc[S\n b] each independent claim, were any of the claims
`
`allowed. Thus, the Examiner never considered the side opening limitations of
`
`dependent claims 3, 4, and 13 to be inventive features standing alone. Neither the
`
`Patentee nor the Examiner cited any support for the substitution. A Notice of
`
`Allowance was mailed August 3, 2011, and tVS o*-, FObS\b WaacSR ]\ D]dS[PS‘ +’
`
`2011. (Exh. 1002 at 89-95.)
`
`7B& REQUIREMENTS FOR INTER PARTES REVIEW
`
`As set forth below and pursuant to 37 C.F.R. § 42.104, each requirement for
`
`inter partes ‘SdWSe ]T bVS o*-, FObS\b Wa aObWaTWSR(
`
`Grounds for Standing Under 37 C.F.R. § 42.104(a)
`/&
`FSbWbW]\S‘ QS‘bWTg bVOb bVS p*-, ^ObS\b %;f( +**+&’ Wa OdOWZOPZS T]‘ inter partes
`
`review and that Petitioner is not barred or estopped from requesting an inter partes
`
`review challenging the claims on the grounds identified in this petition.
`
`9
`
`

`

`0&
`
`Identification of Challenge and Relief Requested
`
`Pursuant to 37 C.F.R. § 42.104(b), the precise relief requested by Petitioner
`
`is that claims 1-.’ 2’ ++’ +-’ O\R +1 ]T bVS o*-, FObS\b PS T]c\R c\^ObS\bOPZS(
`
`Claims for Which Inter Partes Review Is Requested
`1&
`Pursuant to 37 CFR § 42.104(b)(1), Petitioner requests inter partes review
`
`of claims 1-.’ 2’ ++’ +-’ O\R +1 ]T bVS o*-, FObS\b(
`
`2&
`
`The Specific Art and Statutory Ground(s) on Which the
`Challenge Is Based Under 37 C.F.R. § 42.104(b)(2)
`
`This Petition, supported by the grounds set forth below and the Solar
`
`Declaration, demonstrates a reasonable likelihood that Petitioner will prevail with
`
`respect to at least one of the challenged claims and that each of the challenged
`
`claims is unpatentable for the reasons cited herein. See 35 U.S.C. § 314(a). Dr.
`
`Solar, an expert with thirty-seven years of academic and industry experience in the
`
`field of interventional cardiology devices has reviewed the claim charts submitted
`
`W\ bVS o*-, FSbWbW]\ O\R Wa Wn agreement with the grounds of invalidity and the
`
`evidentiary support set forth therein. (See Exh. 1003 ¶ 81.) Inter partes review is
`
`requested in view of the following references and specific grounds for rejection
`
`under 35 U.S.C. §§ 102 and 103.
`
`No.
`1
`2
`3
`
`Grounds
`Claims 1-,’ 2’ ++’ +1 O‘S O\bWQW^ObSR Pg JH /’/,1’,3, %m6RO[a o,3,n&
`Claims 1-.’ 2’ ++’ +- O\R +1 O‘S ]PdW]ca ]dS‘ 6RO[a o,3, W\ dWSe ]T JH
`/’110’+.+ %mAZSW\n&
`Claims 1-.’ 2’ ++’ +- O\R +1 O‘S ]PdW]ca ]dS‘ 6RO[a o,3, W\ dWSe ]T JH
`
`10
`
`

`

`4
`
`5
`
`6
`
`7,232,452 %m6RO[a o./,pn&
`Claims 1-.’ 2’ ++’+-’ O\R +1 O‘S ]PdW]ca ]dS‘ 6RO[a o,3, W\ dWSe ]T JH
`/’-,2’.1, %mHbSW\YSn&
`8ZOW[a +’ ,’2’ ++’ O\R +1 O‘S ]PdW]ca ]dS‘ 6RO[a o,3, W\ dWSe ]T
`Knowledge of One of Skill in the Art
`Claims 1, 2, 8, 11, and 17 are ]PdW]ca ]dS‘ 6RO[a o,3, W\ dWSe ]T mDSe
`Method to Increase a Backup Support of a 6 French Guiding Coronary
`8ObVSbS‘’n ,**.’ IOYOVOaVW E\ZW\S 6‘bWQZS %mIOYOVOaVWn&
`
`Petitioner reserves the right
`
`to present new arguments and prior art
`
`references if the Patent Owner moves to amend the challenged claims.
`
`Construction Of The Challenged Claims
`3&
`Pursuant to 37 C.F.R. § 42.100(b), the claims subject to inter partes review
`
`aVOZZ ‘SQSWdS bVS mP‘]ORSab ‘SOa]\OPZS Q]\ab‘cQbW]\ W\ ZWUVb ]T bVS a^SQWTWQObW]\ ]T
`
`the pate\b W\ eVWQV MbVSgN O^^SO‘MN(nSee 37 C.F.R. § 42.100 (b); see also, In re
`
`Swanson, 540 F.3d 1368, 1377-78 (Fed. Cir. 2008); In re Trans Texas Holding
`
`Corp., 498 F.3d 1290, 1298 (Fed. Cir. 2007) (citing In re Yamamoto, 740 F.2d
`
`1569, 1571 (Fed. Cir. 1984). Because the standards of claim interpretation used by
`
`the Courts in patent litigation differ from those used by the Office in inter partes
`
`review proceedings, claim interpretations submitted herein to demonstrate a
`
`Reasonable Likelihood of Prevailing are not binding upon Petitioner in any
`
`litigation and may not correspond to claim constructions under the legal standards
`
`that govern court proceedings. All claim terms not specifically addressed below
`
`have been accorded their broadest reasonable interpretation %m7G?n& W\ ZWUVb ]T bVS
`
`11
`
`

`

`patent specification, including their plain and ordinary meaning to the extent such a
`
`meaning could be determined by a skilled artisan.1
`
`(&
`
`[SDLN TUSVFUVSH XLUKQVU D NVOHP\
`
`7SQOcaS bVS o*-, ^ObS\b R]Sa \]b RWaQZ]aS O\g ab‘cQbc‘S T]‘ bVS m‘OWZ ab‘cQbc‘S
`
`eWbV]cb O Zc[S\n ZW[WbObW]\ ]T W\RS^S\RS\b QZOW[a + O\R ++’ Wb Wa W\dOZWR c\RS‘ -/
`
`J(H(8( i++,’ j,( IVS e]‘R m‘OWZn O^^SO‘a W\ bVS a^SQWTWQObW]\ ]T bVS o*-, ^ObS\b
`
`only twice. First’ bVS Hc[[O‘g ]T bVS ?\dS\bW]\ ‘STS‘a b] O mUcWRSeW‘S ‘Oil
`
`aSU[S\b’n RSTW\SR Oa m^S‘[WbMW\UN RSZWdS‘g eWbV]cb PZ]QYW\U bVS caS ]T bVS UcWRS
`
`QObVSbS‘(n %;fV( 1001, 2:55-56.) Second, <WU( +1 Wa RSaQ‘WPSR Oa mO ^ZO\ dWSe ]T O
`
`Q]OfWOZ UcWRS QObVSbS‘ VOdW\U O Z]\US‘ ‘OWZ aSU[S\b’n eWbV]cb O\g UcWRO\QS Oa b]
`
`which po‘bW]\%a& ]T <WUc‘S +1 Q]\abWbcbS bVS m‘OWZ aSU[S\b(n %Id., 5:57-59.) Neither
`
`]T bVSaS ‘STS‘S\QSa RWaQZ]aSa O\g [SO\W\U T]‘ m‘OWZn W\ bVS QZOW[ bS‘[ m‘OWZ
`
`ab‘cQbc‘S eWbV]cb O Zc[S\(n %;fV( +**- j 63.) Moreover, nothing in the
`
`specification suggests that the ‘OWZ ab‘cQbc‘S Q]\aWaba ]T bVS mbO^S‘SR W\\S‘ QObVSbS‘’n
`
`mTcZZ
`
`QW‘Qc[TS‘S\QS
`
`^]‘bW]\’n
`
`mQcb]cb
`
`^]‘bW]\’n
`
`m‘SW\T]‘QSR
`
`^]‘bW]\’n
`
`mVS[WQgZW\R‘WQOZ ^]‘bW]\’n maSQ]\R TcZZ QW‘Qc[TS‘S\QS ^]‘bW]\’n mO‘QcObS ^]‘bW]\’n
`
`mP‘OWR ]‘ Q]WZ
`
`‘SW\T]‘QS[S\b’n m[]ab ^‘]fW[OZ portion of braid or coil
`
`1
`
`FSbWbW]\S‘ ‘SaS‘dSa bVS ‘WUVb b] QVOZZS\US bVS dOZWRWbg ]T bVS o*-, ^ObS\b QZOW[a
`
`based on a failure to comply with § 112 ¶¶ 1, 2, and 6, in any proceeding.
`
`12
`
`

`

`‘SW\T]‘QS[S\b’n m‘SZWST Qcb’n mVS[W-bcPS ^]‘bW]\’n maW\UZS Qcba’n mR]cPZS Qcba’n
`
`mQ]\\SQb]‘ VcP’n mTc\\SZ ^]‘bW]\’n mU‘W^ ^]‘bW]\’n b] \O[S O TSe’ \]‘ e]cZR PS a]
`
`read by a POSA. (Id.)
`
`However, 35 U.S.C. § 311(b) prevents Petitioner from challenging the
`
`validity of an original claim based on a failure to comply with 35 U.S.C. § 112 in
`
`this Petition. Accordingly, solely for the purpose of challenging the patentability of
`
`independent apparatus claims 1 and 11 under 35 U.S.C. §§ 102 and 103, and
`
`claims 2, 3, 4, 8, 13, and 17 depending therefrom, Petitioner submits that a POSA
`
`e]cZR c\RS‘abO\R m‘OWZ ab‘cQbc‘Sn b] ‘STS‘ b] O ^caVW\U ]‘ ORdO\QS[S\b ab‘cQbc‘S(
`
`mC]\]‘OWZn ]‘ ‘O^WR SfQVO\US QObVSbS‘a O‘S QVO‘OQbS‘WhSR Pg O ‘SZObWdSZg aV]‘b
`
`gcWRS eW‘S Zc[S\ Ob bVS RWabOZ S\R5 bVWa QO\\]b PS bVS m‘OWZ ab‘cQbc‘Sn T]‘ ^c‘^]aSa
`
`]T bVS QZOW[’ V]eSdS‘’ PSQOcaS bVS QZOW[SR ab‘cQbc‘S [cab PS meWbV]cb O Zc[S\(n
`
`(Exh. 1003 ¶¶ 63-0/(& 6 FEH6 e]cZR bVS‘ST]‘S c\RS‘abO\R bVS m‘OWZ ab‘cQbc‘Sn b]
`
`be the other feature of rapid exchange catheters, a stiffening element that makes
`
`the catheter sufficiently pushable to advance (even though it is not being advanced
`
`over a guide wire throughout its entire length). (Id., ¶¶ 63-65) Accordingly, the
`
`bS‘[ m‘OWZ ab‘cQbc‘S eWbV]cb O Zc[S\n QO\ PS Q]\ab‘cSR T]‘ ^c‘^]aSa ]T bVWa FSbWbW]\
`
`b] [SO\ O m^caVW\U ]‘ ORdO\QS[S\b ab‘cQbc‘S eWbV]cb O Zc[S\(n
`
`)&
`
`[LPUHSWHPULQPDN FDSGLQNQJZ GHWLFH$T%\
`
`13
`
`

`

`Interventional cardiology devices are thin, flexible treatment devices, such
`
`as guidewires, balloon catheters, filters, stents, stent catheters, or other devices to
`
`treat a blockage (occlusion) or narrowing (stenosis) in the arteries due to
`
`atherosclerotic plaques or other lesions. (Id( j 00& IVS a^SQWTWQObW]\ ]T bVS o*-,
`
`patent expressly definSa bVS bS‘[ mW\bS‘dS\bW]\OZ QO‘RW]Z]Ug RSdWQSan Q]\aWabS\bZg
`
`with this construction. (Exh. 1001, 1:19-,+ %m<]‘ bVS ^c‘^]aSa ]T bVWa O^^ZWQObW]\’
`
`bVS bS‘[ oW\bS‘dS\bW]\OZ QO‘RW]Z]Ug RSdWQSa Wa b] PS c\RS‘ab]]R b] W\QZcRS Pcb \]b
`
`be limited to guidewires, baZZ]]\ QObVSbS‘a’ abS\ba O\R abS\b QObVSbS‘an&(&
`
`*&
`
`[UQ SHFHLWH DP LPUHSWHPULQPDN FDSGLQNQJZ GHWLFH LPUQ UKH
`coaxial lumen while the proximal portion remains within
`UKH NVOHP QI UKH JVLGH FDUKHUHS\ ’ [DGDRUHG UQ SHFHLWH DP
`interventional cardiology device passed through continuous
`lumen of the guide catheter and into the coaxial lumen
`XKLNH UKH GHWLFH LT LPTHSUHG LPUQ UKH FQPULPVQVT NVOHP\
`
`Dependent claim 3 recites that the structure of the proximal side opening is
`
`mb] ‘SQSWdS O\ W\bS‘dS\bW]\OZ QO‘RW]Z]Ug RSdWQS W\b] bVS Q]OfWOZ Zc[S\ eVWZS bVS
`
`^‘]fW[OZ ^]‘bW]\ ‘S[OW\a eWbVW\ bVS Zc[S\ ]T bVS UcWRS QObVSbS‘(n 9S^S\RS\b QZOW[
`
`13 similarly recites O\ ]^S\W\U mORO^bSR b] ‘SQSWdS O\ W\bS‘dS\bW]\OZ QO‘RW]Z]Ug
`
`device passed through continuous lumen of the guide catheter and into the coaxial
`
`Zc[S\ eVWZS bVS RSdWQS Wa W\aS‘bSR W\b] bVS Q]\bW\c]ca Zc[S\(n (Exh. 1001, claim
`
`3). This language merely indicates the intended use of the claimed proximal
`
`opening (to receive an interventional cardiology device), and the device itself (for
`
`use within a guide catheter) as well as the order in which such intended uses may
`
`14
`
`

`

`]QQc‘ %‘SQSWdW\U bVS RSdWQS mW\b] bVS Q]Oxial lumen while the proximal portion
`
`‘S[OW\a eWbVW\ bVS Zc[S\ ]T bVS UcWRS QObVSbS‘n&( %Id., 11:1-3.) Accordingly, such
`
`language should not be read as positive limitations on apparatus claims 3 or 13 of
`
`bVS o*-, ^ObS\b( I] bVS SfbS\b bVOb bVS‘S Wa O\g _cSstion as to whether such
`
`language constitutes statements of intended use, the question should be resolved in
`
`favor of the BRI of the claims such that only the structural limitation(s) of claims 3
`
`and 13 (namely, a skived proximal opening) are accorded patentable weight. The
`
`Federal Circuit has made clear that the validity of an apparatus claim depends
`
`solely m]\ bVS QZOW[SR ab‘cQbc‘S MO\RN \]b ]\ bVS caS ]‘ ^c‘^]aS ]T bVOb ab‘cQbc‘S(
`
`Catalina Mktg. Int'l Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir.
`
`2002).
`
`7SQOcaS bVS o*-, ^ObS\b QZOW[a O‘S O^^O‘Obca QZOW[a’
`
`bVS ‘S_cWaWbS
`
`invalidity analysis turns on a direct comparison of the claimed structures to
`
`prior art structures% 399 -6BA?=@6 1>C<% /@CF?$ (+, .%)8 6C +’& %mI] V]ZR
`
`otherwise would effectively impose a method limitation on an apparatus claim
`
`eWbV]cb XcabWTWQObW]\n&5 In re Shreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
`
`The functional statements in claims 3 and 13 are not structural because the entire
`
`structure of the proximal side opening is described elsewhere in the claim;
`
`deletion of the functional phrases from claims 3 and 13 would not affect the
`
`structure of the claimed proximal opening. At most, the language requires a
`
`15
`
`

`

`proximal opening large enough to allow passage of an interventional cardiology
`
`device.
`
`Petitioner has, nevertheless, included sufficient evidence such that, even
`
`if the Board were to construe these functional statements of intended use as
`
`positive limitations of claims 3 and 13, the grounds for unpatentability set forth
`
`below still render the challenged claims invalid in view of the cited art.
`
`+&
`
`[DGDRUHG UQ EH HYUHPGHG EHZQPG UKH GLTUDN HPG