PRIVILEGED AND CONFIDENTIAL
`ATTORNEY WORK PRODUCT
`
`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.
`
`A.
`
`B.
`
`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
`GIBB5FK D; F9A9J5CH H97=CDAD<K 5C8 n),+ E5H9CH .........3
`A.
`Overview Of Interventional Cardiology Procedures ............................3
`B.
`8R‘P_V]aV\[ DS HUR 5YYRTRQ >[cR[aV\[ DS HUR n),+ ENaR[a..................4
`C.
`GbZZN_f \S aUR E_\‘RPbaV\[ =V‘a\_f \S aUR n),+ ENaR[a ......................6
`IV. REQUIREMENTS FOR INTER PARTES REVIEW ....................................9
`A.
`Grounds for Standing Under 37 C.F.R. § 42.104(a)...........................10
`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 ............................................14
`1.
`l_NVY ‘a_bPab_R dVaU\ba N YbZR[m................................................15
`2.
`lV[aR_cR[aV\[NY PN_QV\Y\Tf QRcVPR$‘%m.......................................16
`3.
`la\ _RPRVcR N[ V[aR_cR[aV\[NY PN_QV\Y\Tf QRcVPR V[a\ aUR
`coaxial lumen while the proximal portion remains within the
`YbZR[ \S aUR TbVQR PNaURaR_m ( lNQN]aRQ a\ _RPRVcR N[
`interventional cardiology device passed through continuous
`lumen of the guide catheter and into the coaxial lumen while
`aUR QRcVPR V‘ V[‘R_aRQ V[a\ aUR P\[aV[b\b‘ YbZR[m ....................17
`lNQN]aRQ a\ OR ReaR[QRQ beyond the distal end of the guide
`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
`QV‘Y\QTR aUR TbVQR PNaURaR_ S_\Z aUR O_N[PU N_aR_fm.............19
`The Prior Art References.....................................................................20
`1.
`Mihara .......................................................................................21
`2.
`Takahashi ..................................................................................22
`
`TABLE OF CONTENTS
`
`Page
`
`4.
`
`ii
`
`

`
`How The Construed Claim(s) Are Unpatentable................................23
`C.
`Supporting Evidence Under 37 C.F.R. § 42.104(b)(5) .......................23
`D.
`VII. DETAILED EXPLANATION OF PERTINENCE AND MANNER OF
`APPLYING CITED PRIOR ART TO EVERY CLAIM FOR WHICH
`REVIEW IS REQUESTED UNDER 37 C.F.R. § 42.104(b) (4)..................23
`A.
`Claims 1, 2, 3, 4, 11, and 13 Are Anticipated Under 35 U.S.C.
`§102(b) By Mihara..............................................................................24
`1.
`Claim 2......................................................................................31
`2.
`Claims 3, 4, and 13....................................................................32
`3.
`Claim 11....................................................................................34
`Claims 1, 2, 3, 4, 11 And 13 Are Obvious Under 35 U.S.C. §103
`Over Mihara In View of the Knowledge of a Person of Ordinary
`Skill in the Art .....................................................................................50
`Claims 1-4, 8, 11, 13 and 17 Are Obvious Under 35 U.S.C. §103(a)
`Over Mihara In View Of Takahashi....................................................51
`VIII. CONCLUSION..............................................................................................54
`
`B.
`
`C.
`
`iii
`
`

`
`Exhibit List for Inter Partes Review of U.S. Patent No. 8,048,032
`
`Exhibit No.
`1001
`1002
`1003
`
`1004
`1005
`1006
`1007
`1008A
`
`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
`FRcVRd ;VYRQ 7\[Pb__R[aYf Of ERaVaV\[R_ \[ aUR n),+ ENaR[a
`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.
`HNXNUN‘UV Ra NY’& lCRd BRaU\Q a\ >[P_RN‘R N 6NPXb] Gb]]\_a \S N /
`;_R[PU <bVQV[T 7\_\[N_f 7NaURaR_&m 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
`
`

`
`Exhibit Description
`Declaration of HowarQ F\\a >[ Gb]]\_a \S JN‘PbYN_ G\YbaV\[& >[P’o‘
`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,
`>[P’o‘ B\aV\[ S\_ E_RYVZV[N_f >[Wb[PaV\[ SVYRQ V[ 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
`EYNV[aVSSo‘ B\aV\[ S\_ E_RYVZV[N_f >[Wb[PaV\[ SVYRQ V[ Vascular
`Solutions, Inc. v. Boston Scientific Corporation, No. 13-cv-1172
`(JRT-SER) (D. Minn). (December 19, 2013)
`6\‘a\[ GPVR[aVSVP 7\_]\_NaV\[o‘ B\aV\[ S\_ An Interim Stay and
`Stay Pending Appeal, No. 2014-1185 (Fed. Cir). filed December 27,
`2013
`JN‘PbYN_ G\YbaV\[‘& >[P’o‘ D]]\‘VaV\[ a\ 6\‘a\[ GPVR[aVSVP
`7\_]\_NaV\[o‘ B\aV\[ S\_ 5[ >[aR_VZ GaNf N[Q GaNf ER[QV[T 5]]RNY&
`No. 2014-1185 (Fed. Cir). filed January 3, 2014
`6\‘a\[ GPVR[aVSVP 7\_]\_NaV\[o‘ C\[-Confidential Opening Brief,
`No. 2014-1185 (Fed. Cir). filed January 7, 2014
`JN‘PbYN_ G\YbaV\[‘& >[P’o‘ C\[-Confidential Responsive Brief, No.
`2014-1185 (Fed. Cir). filed January 29, 2014
`6\‘a\[ GPVR[aVSVP 7\_]\_NaV\[o‘ FR]Yf 6_VRS& C\’ +)*--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.
`
`Exhibit No.
`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, 17 of
`
`PRIVILEGED AND CONFIDENTIAL
`ATTORNEY WORK PRODUCT
`
`U.S. Patent No. 8,048,032 $laUR n),+ ENaR[am% $9eU’ *))*%’
`
`0&
`
`MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
`
`The following mandatory notices are provided as part of this Petition.
`
`,&
`
`Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
`
`Boston Scientific Corporation and Boston Scientific Scimed,
`
`Inc.
`
`$P\YYRPaVcRYf lERaVaV\[R_m% N_R aUR _RNY ]N_aVR‘-in-interest.
`
`-&
`
`Related Matters (37 C.F.R. § 42.8(b)(2))
`
`HUR n),+ ENaR[a V‘ ]_R‘R[aYf aUR ‘bOWRPa \S YVaVTNaV\[ O_\bTUa Of aUR ENaR[a
`
`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. 13-1172
`
`(JRT/SER) (May 16, 2013). Petitioner is also seeking inter partes review of the
`
`n),+ ENaR[a \[ \aUR_ T_\b[Q‘ V[ N[\aUR_ ]RaVaV\[ a\ OR SVYRQ P\[Pb__R[aYf UR_RdVaU’
`
`Further, Petitioner is filing two separate petitions on non-redundant grounds
`
`seeking inter partes _RcVRd \S I’G’ ENaR[a C\’ 1&+2+&1.) $aUR ln1.) ]NaR[am% N[Q
`
`\[R ]RaVaV\[ ‘RRXV[T _RcVRd \S I’G’ ENaR[a C\’ 1&*-+&-*, $aUR ln-*, ]NaR[am% a\ OR
`
`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 generally to the
`
`‘NZR ‘bOWRPa ZNaaR_’ G]RPVSVPNYYf& aUR n1.) ]NaR[a V‘ N QVcV‘V\[ \S N]]YVcation No.
`
`1
`
`

`
`*+(1+-&0,-& dUVPU V‘‘bRQ N‘ aUR n-*, ]NaR[a& N[Q aUR n-*, ]NaR[a V‘ N QVcV‘V\[ \S
`
`N]]YVPNaV\[ C\’ **(-*/&/+2& dUVPU V‘‘bRQ N‘ aUR n),+ ]NaR[a’ HUR PYNVZ‘
`
`PUNYYR[TRQ aUR_RV[ N_R ZRaU\Q $n-*, ]NaR[a% N[Q ‘f‘aRZ $n1.) ]NaR[a% cR_‘V\[‘ \S
`
`the apparaab‘ PYNVZ‘ \S aUR n),+ ]NaR[a PUNYYR[TRQ UR_RV[’
`
`.&
`
`Lead And Back-Up Counsel (37 C.F.R. §§ 42.8(b)(3), +)&(’#3$)
`
`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
`
`/&
`
`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.
`
`00&
`
`PAYMENT OF FEES (37 C.F.R. § 42.103)
`
`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.
`
`000&
`
`SUMMARY 81 ;050>-7= =0.378582? -7/ X(+* 9-=07=
`
`,&
`
`Overview Of Interventional Cardiology Procedures
`
`HUR PYNVZ‘ \S aUR n),+ ]NaR[a N_R QV_RPaRQ a\ aUR SVRYQ \S V[aR_cR[aV\[NY
`
`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 guide wires, 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
`
`F\[NYQ ?Nf G\YN_& EU’8’ $lG\YN_ 8RPYN_NaV\[m% (Exh. 1003, ¶ 8)). The physician
`
`V[a_\QbPR‘ aUR a_RNaZR[a QRcVPR V[a\ aUR ]NaVR[ao‘ cN‘PbYN_ ‘f‘aRZ aU_\bTU aUR T_\V[
`
`or wrist and advances it to the site of a blockage to perform a procedureksuch as
`
`the inflation of a balloon or the placement of a stentkto relieve the blockage and
`
`restore blood flow. (Id).. Often, to create a passage for such treatment devices,
`
`]Uf‘VPVN[‘ V[‘R_a N lTbVQR PNaURaR_m RN_YVR_ V[ aUR ]_\PRQb_R’ 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’ HUR n),+ ]NaR[a V‘ QV_RPaRQ a\
`
`an apparatus that is deliverable through a standard guide catheter for extension
`
`3
`
`

`
`beyond the ostium to provide back up supportki.e., to prevent the guide catheter
`
`from being dislodged during the procedure. See, e.g., (Exh. 1001, 2:45-49).
`
`-&
`
`/DOBNHMPHLK 8E =GD -IIDFDC 4KRDKPHLK 8E =GD X(+* 9@PDKP
`
`HUR n),+ ENaR[a $9eU’ *))*% P\[aNV[‘ ++ QRcVPR PYNVZ‘& V[PYbQV[T ad\
`
`V[QR]R[QR[a PYNVZ‘ $PYNVZ‘ * N[Q **%’ HUR ‘]RPVSVPNaV\[ \S aUR n),+ ]NaR[a ‘aNaR‘
`
`that it relates lTR[R_NYYf a\ PNaURaR_‘ b‘RQ V[ V[aR_cR[aV\[NY PN_QV\Y\Tf ]_\PRQb_R‘&m
`
`N[Q lLZM\_R ]N_aVPbYN_Yf ’’’ N]]N_Nab‘ S\_ V[P_RN‘V[T ONPXb] ‘b]]\_a S\_ PNaURaR_‘
`
`V[‘R_aRQ V[a\ aUR P\_\[N_f N_aR_VR‘ S_\Z aUR N\_aN’m $9eU’ *))*& *30-11).
`
`The challenged claims of thR n),+ ]NaR[a N_R [\a ‘a_NVTUaS\_dN_Q’ I[YVXR
`
`af]VPNY N]]N_Nab‘ PYNVZ‘&
`
`aUR n),+ ]NaR[a PYNVZ‘ N_R _R]YRaR dVaU Sb[PaV\[NY
`
`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
`
`\S aUR n),+ ]NaR[a V‘ _R]_R‘R[aNaVcR \S aUR V[QR]R[QR[a PYNVZ‘3
`
`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.
`8R]R[QR[a PYNVZ + \S aUR n),+ ]NaR[a QR]R[Q‘ S_\Z independent claim 1 and
`
`_R^bV_R‘ lthat 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 catheter from the bra[PU N_aR_f’m $Id.,
`
`claim 2).
`
`5
`
`

`
`Dependent claim 3 (depending from independent claim 1 and dependent
`
`claim 2), and dependent claim 13 (depending from independent claim 11), are
`
`QV_RPaRQ a\ N l]_\eVZNY ‘VQR \]R[V[T’’’ReaR[QV[T S\_ N QV‘aN[PR NY\[T aUR
`
`longitudi[NY NeV‘m N[Q la_N[‘cR_‘R Li.e’& Na N[ N[TYRM a\ aUR Y\[TVabQV[NY NeV‘’m
`
`8R]R[QR[a PYNVZ - QR]R[Q‘ S_\Z PYNVZ , N[Q _R^bV_R‘ N l‘a_bPab_R QRSV[V[T N
`
`SbYY PV_PbZSR_R[PR ]\_aV\[ N[Q ‘a_bPab_R QRSV[V[T N ]N_aVNYYf PfYV[Q_VPNY ]\_aV\[&m N‘
`
`would result from a abOR ORV[T ‘XVcRQ Na N[ N[TYR S\_ ]N_a \S Va‘ YR[TaU’ HUR‘R n‘VQR
`
`\]R[V[T PYNVZ‘o N_R QV_RPaRQ a\ aUNa dUVPU dN‘ dRYY X[\d[ V[ aUR N_a dUR[ aUR n),+
`
`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
`
`$QR]R[QV[T S_\Z V[QR]R[QR[a PYNVZ **% _R^bV_R aUNa laUR P_\‘‘-sectional inner
`
`diameter of the coaxial lumen of the tubular structure is not more than one French
`
`smaller than the cross-‘RPaV\[NY V[[R_ QVNZRaR_ \S aUR TbVQR PNaURaR_’m $Id., claim
`
`8).
`
`.&
`
`<QJJ@NU LE PGD 9NLODBQPHLK 3HOPLNU LE PGD X(+* 9@PDKP
`
`HUR n),+ ]NaR[a dN‘ SVYRQ N‘ I’G’ 5]]YVPNaV\[ GR_VNY C\’ **(-*/&/+2 N[Q
`
`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)).
`
`6
`
`

`
`Claims 9 and 12-*. $P\__R‘]\[QV[T TR[R_NYYf a\ PYNVZ‘ * N[Q ** \S aUR n),+
`
`patent) were rejecaRQ N‘ \OcV\b‘ \cR_ I’G’ ENaR[a /&/,1&+/1 $lCVNgVm% $9eU’ *)*,%
`
`in view of U.S. Patent Application Publication No. 2003/0195546 to Solar et al.,
`
`$lG\YN_m% $9eU’ *)*+%’ HUR 9eNZV[R_ S\b[Q aUNa CVNgV QV‘PY\‘RQ NYY Oba laUR
`
`elongate structure with a substantially rigid portion proximal to the reinforced
`
`portion, including a cylindrical portion defining an opening along a side thereof,
`
`aUR YR[TaU \S aUR _VTVQ ]\_aV\[’m $C\[ ;V[NY DSSVPR 5PaV\[ $lC;D5m% $8RP’ .&
`
`2008) at 3 (Exh. 1002 at 351)). The element missing from Niazi was, however,
`
`QV‘PY\‘RQ V[ G\YN_3 lN[ RY\[TNaR QRcVPR P\Z]_V‘V[T N ]b‘UV[T ZRZOR_ . N[Q
`
`a_NPXV[T ZRZOR_ 0 j’m $Id). While the rejection refers to claims 9 and 12-15,
`
`claim 8 is specifically discussed and treated as rejected. (Id. at 2 (Exh. 1002 at
`
`350)).
`
`Claims 9-11, 16, and 21 (corresponding generally to claims 1, 8, 11, and 17
`
`\S aUR n),+ ]NaR[a% dR_R _RWRPaRQ \cR_ aUR ‘NZR P\ZOV[NaV\[ N[Q NQQVaV\[NYYf V[
`
`view of U.S. Patent Application Publication No. 2004/0127927 to Adams, et al.
`
`$l5QNZ‘ n2+0m% $9eU’ *)*.% N[Q I’G’ ENaR[a C\ /&,,1&0+. a\ =R_ZN[[& et al.,
`
`$l=R_ZN[[m% $9eU’ *)*/%’ HUR 9eNZV[R_ S\b[Q aUNa lG\YN_ QV‘PY\‘R‘ N QRP_RN‘V[T
`
`_VTVQVaf NY\[T aUR QRcVPR N‘ \[R a_NcRY‘ QV‘aNYYf’ 5QNZ‘ n2+0 QV‘PY\‘R‘ _RYVRS Pba‘ N‘
`
`a method of forming a non-rigid bendable section in an otherwise straight
`
`ZRZOR_j’m
`
`$Id. at 5 (Exh. 1002 at 353)). The Examiner also found that
`
`7
`
`

`
`l=R_ZN[[ QV‘PY\‘R‘ N ZRaNY P\VY VZORQQRQ V[ N SYReVOYR ‘URNaU a\ Nc\VQ XV[XV[T
`
`N[Q P\YYN]‘R Qb_V[T b‘Rm N[Q lG\YN_ QV‘PY\‘R‘ b‘V[T N Tuidewire 9 to allow the
`
`‘f‘aRZ a\ NQcN[PR RN‘VYf a\ N QR‘V_RQ Y\PNaV\[ dVaUV[ N ]NaVR[ao‘ O\Qf’m $Id. At.5- 6
`
`(Exh. 1002, 353-54)).
`
`Further,
`
`in an Office Action dated November 19, 2009,
`
`the Examiner
`
`maintained the rejection of then-claims 66, 69, and 74 (corresponding generally to
`
`PYNVZ‘ , N[Q - \S aUR n),+ ]NaR[a%& PVaV[T I’G’ ENaR[a C\’ .&00/&*-* a\ @YRV[& et al.,
`
`$l@YRV[m% $9eU’ *)*0%’ G]RPVSVPNYYf& aUR 9eNZV[R_ S\b[Q aUNa3
`
`@YRV[ QV‘PY\‘R‘ N j a_NPXV[T ZRZOR_(‘URNaU j aUNa P\cR_‘ N QRYVcR_f
`catheter j’ 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
`
`j a_NPXV[T ZRZOR_ $V[PYbQV[T aUR PfYV[Q_VPNY ‘UN]R% N‘ aNbTUa Of
`
`@YRV[j’
`(NFOA (Nov. 19, 2009) at 3 (Exh. 1002 at 271) (emphasis added)).
`
`Despite six amendments, the revised claims remained rejected over Niazi in
`
`view of Solar. Moreover, the claim amendments resulted in additional rejections as
`
`the newly presented claims lacked a written description for multiple negative
`
`YVZVaNaV\[‘& V[PYbQV[T aUR TR[b‘ l[\[-abObYN_’m $C;D5 $?bYf ,)& +)*)% Na + $Exh.
`
`1002 at 185); Final Action (Dec. 21, 2010) at 2 (Exh. 1002 at 142)). Applicants
`
`attempted to overcome the written description by asserting, without specific
`
`8
`
`

`
`PVaNaV\[ a\ aUR ‘]RPVSVPNaV\[& aUNa lLaMUR N]]YVPNaV\[ N‘ SVYRQ PYRN_Yf QR‘P_VOR‘ N[Q
`
`differentiates circular, cylindrical tubular shapes from those that are partially
`
`circumferential, non-circular or non-abObYN_’m $FR‘]\[‘R a\ ;V[NY 5PaV\[ $8RP’ +*&
`
`2010) at 11 (Exh. 1002 at 125)).
`
`C\[R \S aUR 5]]YVPN[a‘o N_TbZR[a‘ \_ NZR[QZR[a‘ dR_R ‘bSSVPVR[a4 aUR
`
`PYNVZ‘ dR_R NYY\dRQ \[Yf NSaR_ N[ 9eNZV[R_o‘ NZR[QZR[a following an interview.
`
`lC\[-abObYN_m dN‘ QRYRaRQ S_\Z aUR QR‘P_V]aV\[ \S aUR ‘bO‘aN[aVNYYf _VTVQ ]\_aV\[ V[
`
`aUR V[QR]R[QR[a PYNVZ‘ N[Q aUR 9eNZV[R_ ‘bO‘aVabaRQ lrail structure without a
`
`lumen’m $C\aVPR \S 5YY\dNOVYVaf $C\c’ ,& +)**% $Exh. 1002 at 94)). Only after the
`
`Applicants accepted the addition of that limitation to each independent claim that
`
`any of the claims were allowed. (Neither the Applicants nor the Examiner cited
`
`any support for the substitution).
`
`Thus,
`
`the Examiner never considered the side opening limitations of
`
`QR]R[QR[a PYNVZ‘ ,& -& N[Q *, \_ aUR l\[R ;_R[PUm YVZVaNaV\[ \S QR]R[QR[a PYNVZ 1
`
`to be inventive features standing alone. A Notice of Allowance was mailed August
`
`,& +)**& N[Q aUR n),+ ENaR[a V‘‘bRQ \[ C\cRZOR_ *& +)** $9eU’ *))+%
`
`02& REQUIREMENTS FOR INTER PARTES REVIEW
`
`As set forth below and pursuant to 37 C.F.R. § 42.104, each requirement for
`
`inter partes _RcVRd \S aUR n),+ ENaR[a V‘ ‘NaV‘SVRQ’
`
`9
`
`

`
`Grounds for Standing Under 37 C.F.R. § 42.104(a)
`,&
`ERaVaV\[R_ PR_aVSVR‘ aUNa aUR n),+ ]NaR[a (Ex. 1001), is available for 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.
`
`-&
`
`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--& 1& **& *,& N[Q *0 \S aUR n),+ ENaR[a OR S\b[Q b[]NaR[aNOYR’
`
`Claims for Which Inter Partes Review Is Requested
`.&
`Pursuant to 37 CFR § 42.104(b)(1), Petitioner requests inter partes review
`
`of claims 1--& 1& **& *,& N[Q *0 \S aUR n),+ ENaR[a’
`
`/&
`
`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
`
`V[ aUR n),+ ERaVaV\[ N[Q V‘ V[ NT_RRZR[a dVaU aUR T_\b[Q‘ \S V[cNYVQVaf N[Q aUR
`
`evidentiary support set forth therein. (See Exh. 1003 ¶ 81). Inter partes review is
`
`10
`
`

`
`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 1-4, 11, and 13 are anticipated by U.S. Pub. No. 2004/0236215 to
`Mihara, et. al.
`Claims 1-4, 11, and 13 are obvious over Mihara in view of the Knowledge
`of One of Skill in the Art
`7YNVZ‘ 1 N[Q ** N_R \OcV\b‘ \cR_ BVUN_N V[ cVRd \S lCRd BRaU\Q a\
`>[P_RN‘R N 6NPXb] Gb]]\_a \S N / ;_R[PU <bVQV[T 7\_\[N_f 7NaURaR_&m
`Catherization and Cardiovascular Interventions 63:452-456 (2004),
`HNXNUN‘UV D[YV[R 5_aVPYR $lHNXNUN‘UVm% $9eUVOVa *)+)%
`
`Petitioner reserves the right
`
`to present new arguments and prior art
`
`references if the Patent Owner moves to amend the challenged claims.
`
`2&
`
`Non-Redundancy of Proposed Alternative Grounds
`
`Petitioner urges the Board to adopt each ground of unpatentability raised
`
`with respect to claims 1--& 1& **& *, N[Q *0 \S aUR n),+ ]NaR[a S\_ Na YRN‘a aUR
`
`following reasons. The proposed grounds for institution presented in the present
`
`ERaVaV\[ $lERaVaV\[ 6m% N_R [\a _RQb[QN[a \cR_ RNPU \aUR_& \_ \cR_ aUR T_\b[Q‘ \S
`
`rejection presented in the concurrently filed parallel Petition for inter partes review
`
`\S aUR PUNYYR[TRQ PYNVZ‘ \S aUR n),+ ]NaR[a& $lERaVaV\[ 5m $9eU’ *))1%%& ORPNb‘R
`
`several differences exist between the applied prior art and their respective grounds
`
`for unpatenaNOVYVaf’ ;\_ ReNZ]YR& aUR ]_VZN_f ]_V\_ N_a _RSR_R[PR $l5QNZ‘ n+2+m%
`
`(Exh. 1011) in parallel Petition A differs from the primary prior art reference
`
`_NV‘RQ UR_RV[ $lBVUN_Nm% $9eU’ *))2%’ BVUN_N N[aVPV]NaR‘ N QVSSR_R[a ‘Ra \S
`
`11
`
`

`
`dependent claims (claims 3, 4, and 13) through its disclosure of a skived proximal
`
`side opening in Figures 1-,’ 5QNZ‘ n+2+ N[aVPV]NaR‘ aUR PYNVZRQ QVSSR_R[PR V[
`
`diameter between the inner diameter of the device and the inner diameter of the
`
`‘aN[QN_Q TbVQR PNaURaR_ \S l[\a Z\_R aUN[ \[R ;_R[PUm $PYNVZ‘ 1 N[Q *0%’ 5‘ N
`
`result, during the course of this proceeding, if instituted, Patent Owner could
`
`amend the claims to be limited to just one of these claimed embodiments that is not
`
`P\cR_RQ Of N[aVPV]NaV\[ V[ cVRd \S 5QNZ‘ n+2+ $ERaVaV\[ 5% or Mihara (Petition B)
`
`NY\[R’ 5PP\_QV[TYf& NYY T_\b[Q‘ ON‘RQ \[ O\aU 5QNZ‘ n+2+ N[Q BVUN_N N_R [RRQRQ
`
`to cover all of the embodiments encompassed by claims 1, 2, and 12, and, as such,
`
`N_R [\a _RQb[QN[a’ >[QRRQ& ORPNb‘R \S aUR ENaR[a Dd[R_o‘ b[_RN‘\[NOYf Sunctional
`
`and broad claims, it is imperative that each ground of unpatentability be adopted so
`
`that the Patent Owner will be forced to address the differences in the underlying
`
`structures of the systems in the cited references, and so that Petitioner may address
`
`any arguments by the Patent Owner regarding the ability of structures in the prior
`
`art to perform the various functions recited in each of the challenged claims.
`
`For similar reasons, the grounds of unpatentability raised in the present
`
`Petition regarding the obviousness of the side-opening limitations of claims 3, 4,
`
`and 14 are not redundant given that the far reaching functional language of such
`
`PYNVZ‘ [RPR‘‘VaNaR ERaVaV\[R_o‘ NYaR_[NaVcR ]_\]\‘RQ T_\b[Q‘ \S b[]NaR[aNOVYVaf \[
`
`12
`
`

`
`the basis of both anticipation in view of Mihara and obviousness over Mihara in
`
`view of the knowledge of one of skill in the art.
`
`If the PTAB disagrees and determines that the grounds raised herein are
`
`redundant of those raised in Petition A, and will institute only on the grounds of
`
`one Petition, Petitioner respectfully requests institution on the basis of Petition A.
`
`Moreover, if the PTAB determines that there is redundancy with respect to the
`
`grounds raised herein regarding anticipation in view of Mihara and obviousness of
`
`claims 3, 4, and 14 over Mihara in combination with the knowledge of one of skill
`
`in the art, Petitioner suggests institution on the grounds of Mihara in view of the
`
`knowledge of one of skill in the art.
`
`20& Level of Skill In the Art
`
`A person of ordinary ‘XVYY V[ aUR N_a $lEDG5m% Na aUR aVZR \S aUR NYYRTRQ
`
`V[cR[aV\[ \S aUR n),+ ]NaR[a d\bYQ UNcR ORR[ ‘\ZR\[R dVaU Na YRN‘a aUR R^bVcNYR[a
`
`of a medical degree from an accredited institution (usually denoted in this country
`
`as a M.D. degree) or someone with the equivalent of a masters degree from an
`
`accredited institution (usually denoted in this country as an M.S. degree) in
`
`biomedical engineering. The person must have at least three years of experience
`
`working as an interventional cardiologist, interventional radiologist, cardiothoracic
`
`surgeon, interventionalist, or biomedical engineer or biomedical device designer
`
`and/or manufacturer. Extensive experience and technical training might substitute
`
`13
`
`

`
`for educational
`
`requirements, while advanced degrees might substitute for
`
`experience. (Exh. 1003 ¶ 28).
`
`Construction Of The Challenged Claims
`,&
`Pursuant to 37 C.F.R. § 42.100(b), the claims subject to inter partes review
`
`‘UNYY _RPRVcR aUR lO_\NQR‘a _RN‘\[NOYR P\[‘a_bPaV\[ V[ YVTUa \S aUR ‘]RPVSVPNaV\[ \S
`
`the patent in whVPU LaURfM N]]RN_LM’mSee 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 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
`
`_RN‘\[NOYR V[aR_]_RaNaV\[ $l6F>m% V[ light of the patent specification, including
`
`14
`
`

`
`their plain and ordinary meaning to the extent such a meaning could be determined
`
`by a skilled artisan.1
`
`(&
`
`VN@HI OPNQBPQND SHPGLQP @ IQJDKW
`
`6RPNb‘R aUR n),+ ]NaR[a Q\R‘ [\a QV‘PY\‘R N[f ‘a_bPab_R S\_ aUR l_NVY ‘a_bPab_R
`
`dVaU\ba N YbZR[m YVZVaNaV\[ \S V[QR]R[QR[a PYNVZ‘ * N[Q **& Va V‘ V[cNYVQ b[QR_ ,.
`
`I’G’7’ h**+& i+’ HUR d\_Q l_NVYm N]]RN_‘ V[ aUR ‘]RPVSVPNaV\[ \S aUR n),+ ]NaR[a
`
`only twice. First& aUR GbZZN_f \S aUR >[cR[aV\[ _RSR_‘ a\ N lTbVQRdV_R _NVY
`
`‘RTZR[a&m QRSV[RQ N‘ l]R_ZVaLV[TM QRYVcR_f dVaU\ba OY\PXV[T aUR b‘R \S aUR TbVQR
`
`PNaURaR_’m $9eU’ 1001, 2:55-56). Second, ;VT’ *0 V‘ QR‘P_VORQ N‘ lN ]YN[ cVRd \S N
`
`coaxial guide catheter havinT N Y\[TR_ _NVY ‘RTZR[a&m dVaU\ba N[f TbVQN[PR N‘ a\
`
`dUVPU ]\_aV\[$‘% \S ;VTb_R *0 P\[‘aVabaR aUR l_NVY ‘RTZR[a’m $Id., 5:57-59). Neither
`
`\S aUR‘R _RSR_R[PR‘ QV‘PY\‘R‘ N[f ZRN[V[T S\_ l_NVYm V[ aUR PYNVZ aR_Z l_NVY
`
`‘a_bPab_R dVaU\ba N YbZR[’m $9eU’ *)), i 63). Moreover, nothing in the
`
`‘]RPVSVPNaV\[ ‘bTTR‘a‘ aUNa aUR _NVY ‘a_bPab_R P\[‘V‘a‘ \S aUR laN]R_RQ V[[R_ PNaURaR_&m
`
`lSbYY
`
`PV_PbZSR_R[PR
`
`]\_aV\[&m
`
`lPba\ba
`
`]\_aV\[&m
`
`l_RV[S\_PRQ
`
`]\_aV\[&m
`
`lURZVPfYV[Q_VPNY ]\_aV\[&m l‘RP\[Q SbYY PV_PbZSR_R[PR ]\_aV\[&m lN_PbNaR ]\_aV\[&m
`
`lO_NVQ \_ P\VY
`
`_RV[S\_PRZR[a&m lZ\‘a ]_\eVZNY ]\_aV\[ \S O_NVQ \_ P\VY
`
`1
`
`ERaVaV\[R_ _R‘R_cR‘ aUR _VTUa a\ PUNYYR[TR aUR cNYVQVaf \S aUR n),2 patent claims
`
`based on a failure to comply with § 112 ¶¶ 1, 2, and 6, in any proceeding.
`
`15
`
`

`
`_RV[S\_PRZR[a&m l_RYVRS Pba&m lURZV-abOR ]\_aV\[&m l‘V[TYR Pba‘&m lQ\bOYR Pba‘&m
`
`lP\[[RPa\_ UbO&m lSb[[RY ]\_aV\[&m lT_V] ]\_aV\[&m a\ [NZR N SRd& [\_ d\bYQ OR ‘\
`
`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
`
`d\bYQ b[QR_‘aN[Q l_NVY ‘a_bPab_Rm a\ _RSR_ a\ N ]b‘UV[T \_ NQcN[PRZR[a ‘a_bPab_R’
`
`lB\[\_NVYm \_ _N]VQ exchange catheters are characterized by a relatively short
`
`QV‘aNY TbVQR dV_R YbZR[4 aUV‘ PN[[\a OR aUR l_NVY ‘a_bPab_Rm S\_ ]b_]\‘R‘ \S aUR
`
`PYNVZ& U\dRcR_& ORPNb‘R aUR PYNVZRQ ‘a_bPab_R Zb‘a OR ldVaU\ba N YbZR[’m $9eU’
`
`1003 ¶¶ 63-65). A POSA would therefo_R b[QR_‘aN[Q aUR l_NVY ‘a_bPab_Rm a\ OR aUR
`
`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
`
`aR_Z l_NVY ‘a_bPab_R dVaU\ba N YbZR[m PN[ OR P\[‘a_bRQ S\_ ]b_]\‘R‘ \S aUV‘ ERaVaV\[
`
`a\ ZRN[ N l]b‘UV[T \_ NQcN[PRZR[a ‘a_bPab_R dVaU\ba N YbZR[’m
`
`)&
`
`VHKPDNRDKPHLK@I B@NCHLILFU CDRHBD$O%W
`
`16
`
`

`
`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. ¶ 66). TUR ‘]RPVSVPNaV\[ \S aUR n),+
`
`]NaR[a Re]_R‘‘Yf QRSV[R‘ aUR aR_Z lV[aR_cR[aV\[NY PN_QV\Y\Tf QRcVPR‘m P\[‘V‘aR[aYf
`
`dVaU aU