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 8,142,413 B2
`
`________________
`
`Attorney Docket No. 0025216-00057
`
`________________
`
`PETITION FOR INTER PARTES REVIEW
`UNDER 37 C.F.R. § 42.100
`
`
`
`
`
`
`

`

`
`
`TABLE OF CONTENTS
`
`Page
`
`I. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) ...................................... 5
`A.
`Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) .................................... 5
`B.
`Related Matters (37 C.F.R. § 42.8(b)(2)) .............................................. 5
`C.
`Lead And Back-Up Counsel (37 C.F.R. §§ 42.8(b)(3), 42.10(a)) ........ 6
`D.
`Service Information (37 C.F.R. § 42.8(b)(4)) ....................................... 6
`
`II.
`
`PAYMENT OF FEES (37 C.F.R. § 42.103) ................................................... 6
`
`III. SUMMARY OF RELEVANT TECHNOLOGY AND ‘413 PATENT ......... 6
`A. Overview Of Interventional Cardiology Procedures ............................ 7
`B. Description Of The Alleged Invention Of The ‘413 Patent .................. 8
`C.
`Summary of the Prosecution History of the ‘413 Patent ....................10
`
`C.
`D.
`
`E.
`
`IV. REQUIREMENTS FOR INTER PARTES REVIEW ..................................12
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a) ...........................12
`B.
`Identification of Challenge Under 37 C.F.R. § 42.104(b) and Relief
`Requested ............................................................................................12
`Claims for Which Inter Partes Review Is Requested .........................12
`The Specific Art and Statutory Ground(s) on Which the Challenge
`Is Based Under 37 C.F.R. § 42.104(b)(2) ...........................................12
`Construction Of The Challenged Claims ............................................13
`1.
`“rail structure without a lumen” ................................................14
`2.
`“interventional cardiology device(s)” .......................................16
`The Prior Art References .....................................................................16
`1.
`Adams ‘292 ...............................................................................17
`2.
`Klein ..........................................................................................18
`3.
`Adams ‘452 ...............................................................................18
`4. Mihara .......................................................................................19
`5.
`Steinke .......................................................................................19
`6.
`Takahashi ..................................................................................20
`G. How The Construed Claim(s) Are Unpatentable ................................20
`H.
`Supporting Evidence Under 37 C.F.R. § 42.104(b)(5) .......................21
`
`F.
`
`V. 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) ...................21
`A.
`Claims 1 And 13 Are Anticipated Under 35 U.S.C. §102(b) By
`Adams’292 ..........................................................................................21
`1.
`Claim 1 ......................................................................................22
`
`
`
`1
`
`

`

`
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`I.
`
`Claim 13 ....................................................................................24
`2.
`Statement Of Non-Redundancy: Skived Proximal Opening
`Disclosures in Klein, Adams ‘452, Mihara, And Steinke ...................31
`Claims 1, 4, 9, And 10 Are Obvious Under 35 U.S.C. §103 Over
`Adams ‘292 In View Of The Knowledge Of One Of Ordinary Skill
`In The Art ............................................................................................33
`Claims 1, 4, 9, 10 And 13 Are Obvious Under 35 U.S.C. §103 Over
`Adams ‘292 In View Of Klein ............................................................35
`Claims 1, 4, 9, 10 And 13 Are Obvious Under 35 U.S.C. §103 Over
`Adams ‘292 In View Of Adams ‘452 .................................................40
`Claims 1, 4, 9, 10 and 13 Are Obvious Under 35 U.S.C. §103 Over
`Adams ‘292 In View Of Mihara .........................................................45
`Claims 1, 4, 9, 10 and 13 Are Obvious Under 35 U.S.C. §103 Over
`Adams ‘292 In View Of Steinke .........................................................50
`Claim13 Is Obvious Under 35 U.S.C. §103 Over Adams ‘292 In
`View Of The Knowledge Of One Of Ordinary Skill In The Art ........55
`Claims 1 And 13 Are Obvious Under 35 U.S.C. §103 Over Adams
`‘292 In View Of Takahashi .................................................................57
`
`VI. CONCLUSION ..............................................................................................59
`
`
`
`
`2
`
`

`

`
`
`Exhibit No.
`1001
`1002
`1003
`
`1004
`1005
`1006
`1007
`1008
`1009
`1010
`1011
`1012
`1013
`1014
`1015
`1016
`1017
`
`Exhibit List for Inter Partes Review of U.S. Patent No. 8,142,413
`
`Exhibit Description
`U.S. Patent No. 8,142,413 to Root, et al.
`File History for U.S. Patent No. 8,142,413
`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. 8,048,032 to Root, et al.
`U.S. Patent No. 8,292,850 to Root, et al.
`File History for U.S. Patent No. 8,048,032
`File History for U.S. Patent No. 8,292,850
`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. 5,527,292 to Adams 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.
`Takahashi et al., “New Method to Increase a Backup Support of a 6
`French Guiding Coronary Catheter,” Catherization and
`Cardiovascular Interventions 63:452-456 (2004)
`U.S. Patent No. 5,690,613 to Verbeek
`U.S. Patent No. 5,156,594 to Keith
`U.S. Patent No. 5,102,403 to Alt
`Kucklick, Theodore R., The Medical Device R&D Handbook (2006)
`Amended Complaint filed by Vascular Solutions, Inc. in Vascular
`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)
`Declaration of Howard Root In Support of Vascular Solution, Inc.’s
`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)
`
`1018
`1019
`1020
`1021
`1022
`
`1023
`
`1024
`
`
`
`3
`
`

`

`
`
`Exhibit Description
`Boston Scientific Corporation Opposition to Vascular Solutions,
`Inc.’s Motion for Preliminary Injunction filed in 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
`Plaintiff’s Motion for Preliminary Injunction filed in Vascular
`Solutions, Inc. v. Boston Scientific Corporation, No. 13-cv-1172
`(JRT-SER) (D. Minn.) (December 19, 2013)
`Boston Scientific Corporation’s Motion for An Interim Stay and
`Stay Pending Appeal, No. 2014-1185 (Fed. Cir.) filed December 27,
`2013
`Vascular Solutions, Inc.’s Opposition to Boston Scientific
`Corporation’s Motion for An Interim Stay and Stay Pending Appeal,
`No. 2014-1185 (Fed. Cir.) filed January 3, 2014
`Boston Scientific Corporation’s Non-Confidential Opening Brief,
`No. 2014-1185 (Fed. Cir.) filed January 7, 2014
`Vascular Solutions, Inc.’s Non-Confidential Responsive Brief, No.
`2014-1185 (Fed. Cir.) filed January 29, 2014
`Declaration of Anthony Vrba In Support of Boston Scientific
`Opposition to Motion for Preliminary Injunction filed in Vascular
`Solutions, Inc. v. Boston Scientific Corporation, No. 13-cv-1172
`(JRT-SER) (D. Minn.) (July 8, 2013)
`Boston Scientific Corporation’s Reply Brief, No. 2014-1185
`(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.
`U.S. Publication No. 2004/0236215 A1 to Mihara et al.
`
`
`
`
`4
`
`Exhibit No.
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`1037
`
`1038
`1039
`1040
`
`

`

`
`
`
`
`Inter partes review is respectfully requested for claims 1, 4, 9, 10, and 13 of
`
`U.S. Patent No. 8,142,413 B2 (“the ‘413 Patent”) (Exh. 1001).
`
`I. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
`
`The following mandatory notices are provided as part of this Petition.
`
`A. Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
`
`Boston Scientific Corporation and Boston Scientific Scimed,
`
`Inc.
`
`(collectively “Petitioner”) are the real parties-in-interest.
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2))
`
`The ‘413 Patent is presently the 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. 12-1172
`
`(JRT/SER) (May 16, 2013). Petitioner is also seeking inter partes review of U.S.
`
`Patent No. 8,048,032 B2 (the “‘032 patent”) and U.S. Patent No. 8,292,850 (the
`
`“‘850 patent”) in four petitions being filed concurrently herewith. Petitioner
`
`requests that all of these petitions be assigned to the same Board for administrative
`
`efficiency, as all three patents are closely related and directed generally to the same
`
`subject matter. The ‘850 patent is a divisional of application No. 12/824,734,
`
`which issued as the ‘413 patent, and the ‘413 patent is a divisional of application
`
`No. 11/416,629, which issued as the ‘032 patent. The claims challenged in the
`
`
`
`5
`
`

`

`
`
`concurrently filed petitions are apparatus (‘032 patent) and system (‘850 patent)
`
`versions of the method claims of the ‘413 patent challenged herein.
`
`C. Lead And Back-Up Counsel (37 C.F.R. §§ 42.8(b)(3), 42.10(a))
`
`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
`
`Back-Up 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
`
`
`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
`
`D.
`
`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.
`
`II.
`
`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
`
`any additional fees that might be due in connection with this Petition to be charged
`
`to the above-referenced Deposit Account.
`
`III. SUMMARY OF RELEVANT TECHNOLOGY AND ‘413 PATENT
`
`
`
`6
`
`

`

`
`
`A. Overview Of Interventional Cardiology Procedures
`
`The claims of the ‘413 patent are directed to the field of interventional
`
`cardiology procedures, such as the treatment of obstructive coronary artery disease.
`
`(See Exh. 1001, 1:21-44). 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
`
`Ronald Jay Solar, Ph.D. (“Solar Declaration”) ¶ 8 (Exh. 1003)). The physician
`
`introduces the treatment device into the patient’s vascular system through the groin
`
`or wrist and advances it to the site of a blockage to perform a procedure—such as
`
`the inflation of a balloon or the placement of a stent—to relieve the blockage and
`
`restore blood flow. (Id.) Often, to create a passage for such treatment devices,
`
`physicians insert a “guide catheter” earlier in the procedure. (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.) The ‘413 patent is directed to
`
`methods for delivering an apparatus through a standard guide
`
` catheter, extending beyond the ostium, to provide back up support—i.e., to
`
`prevent the guide catheter from being dislodged during the procedure. (See, e.g.,
`
`Exh. 1001, 2:51-55).
`
`
`
`7
`
`

`

`
`
`B. Description Of The Alleged Invention Of The ‘413 Patent
`
`The ‘413 Patent contains 14 method claims, including one independent
`
`claim (claim 1). The specification of the ‘413 patent states that it relates “generally
`
`to catheters used
`
`in
`
`interventional cardiology procedures,” and “[m]ore
`
`particularly, ... methods … for increasing backup support for catheters inserted into
`
`the coronary arteries of the aorta.” (Exh. 1001, 1:13-17).
`
`The challenged claims of the ‘413 patent are not straightforward; they are
`
`replete ambiguous structural limitations that are unsupported by either the
`
`specification or knowledge in the art at the time of the claimed invention.
`
`Independent claim 1 of the ‘413 patent recites:
`
`1. A method of providing backup support for an interventional
`
`cardiology device for use
`
`in
`
`the coronary vasculature,
`
`the
`
`interventional cardiology device being adapted to be passed through 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, the
`
`method comprising:
`
`inserting the standard guide catheter into a first artery over a
`
`guidewire, the standard guide catheter having a distal end;
`
`positioning the distal end of the standard guide catheter in a branch
`
`artery that branches off from the first artery;
`
`
`
`8
`
`

`

`
`
`
`
`inserting a flexible tip portion of a coaxial guide catheter 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
`
`standard guide catheter, into the continuous lumen of the standard
`
`guide catheter, and,
`
`further inserting a substantially rigid portion that is proximal of,
`
`operably connected to, and more rigid along a longitudinal axis
`
`than the flexible tip portion, into the continuous lumen of the
`
`standard guide catheter, the substantially rigid portion 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;
`
`advancing a distal portion of the flexible tip portion distally beyond
`
`the distal end of the standard guide catheter and into the second
`
`artery such that the distal portion extends into the second artery
`
`and such that at least a portion of the proximal portion of the
`
`substantially rigid portion extends proximally
`
`through
`
`the
`
`hemostatic valve; and
`
`inserting the interventional cardiology device into and through the
`
`continuous lumen of the standard guide catheter alongside of the
`
`substantially rigid portion and advancing the interventional
`
`cardiology device through and beyond a lumen of the flexible tip
`
`portion into contact with or past a lesion in the second artery.
`
`9
`
`

`

`
`
`Dependent claim 4 of the ‘413 patent depends from independent claim 1 and
`
`recites a method “further comprising selecting the substantially rigid portion of the
`
`coaxial guide catheter such that it comprises a cylindrical portion and a partially
`
`cylindrical portion defining an opening along a side thereof.”
`
`Dependent claim 9 of the ‘413 patent depends from independent claim 1 and
`
`recites a method “further comprising extending the interventional cardiology
`
`device through a proximal side opening defined by the proximal portion of the
`
`tubular structure and extending for a distance along the longitudinal axis of the
`
`proximal portion of the tubular structure while the proximal portion remains within
`
`the lumen of the guide catheter.”
`
`Dependent claim 10 of the ‘413 patent (depending from claim 9) recites a
`
`method “further comprising extending the interventional cardiology device through
`
`the proximal side opening; advancing the interventional cardiology device through
`
`structure defining a full circumference portion; and advancing the interventional
`
`cardiology device through structure defining a partially cylindrical portion.”
`
`Dependent claim 13 of the ‘413 patent depends from independent claim 1
`
`and recites a method “further comprising selecting the cross-sectional inner
`
`diameter of the coaxial lumen of the tubular structure to be not more than one
`
`French smaller than the cross-sectional inner diameter of the guide catheter.”
`
`C.
`
`Summary of the Prosecution History of the ‘413 Patent
`
`
`
`10
`
`

`

`
`
`The ‘413 Patent was filed as U.S. App. Serial No. 12/824,734 on June 28,
`
`2010 (see Exh. 1002, paper 1) and claims priority to application No. 11/416,629,
`
`filed on May 3, 2006, which issued as the ‘032 patent.
`
`Claims 1-7 were rejected as obvious over U.S. Patent 6,638,268 (“Niazi”) in
`
`view of U.S. Patent Application Publication No. 2005/0004523 to Osborne, et al.,
`
`(“Osborne”). The Examiner found that Niazi disclosed all but “a rigid portion
`
`proximal to the reinforced portion and at least a portion of the reinforced portion
`
`extending out of the distal end of the guide catheter and into the second blood
`
`vessel.” (Non Final Office Action (Aug. 1, 2011) at 3-4 (Exh. 1002, at 70-71). The
`
`element missing from Niazi was, however, disclosed by Osborne: “a reinforcing
`
`portion 52 and a stiffening cannula 50 within inner cannula 20 to avoid kinking
`
`(Paragraph 36) and provide stiffening (Paragraph 35). Therefore, it would have
`
`been obvious ... to include a reinforcing portion and stiffening portion as taught by
`
`Osborne to the device of Niazi to provide kind resistance and stiffening.” (Id. at 4.)
`
`Regarding claim 4, the Examiner asserted that “[a] side port exists in the
`
`side of catheter 52 for contrast media (5:25-28). The part of the catheter along the
`
`same longitudinal length as the side port is partially cylindrical and the
`
`surrounding areas are fully cylindrical.” (Id. at 4).
`
`In response, Applicant amended claims 1-3, 5, and 7 (corresponding to
`
`claims 1-6 of the ‘413 patent) and cancelled claim 6.
`
`
`
`11
`
`

`

`
`
`A Notice of Allowance was mailed January 17, 2012, and the ‘413 Patent
`
`issued on March 27, 2012.
`
`IV. REQUIREMENTS FOR INTER PARTES REVIEW
`
`As set forth below and pursuant to 37 C.F.R. § 42.104, each requirement for
`
`inter partes review of the ‘032 Patent is satisfied.
`
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`
`Petitioner certifies that the ‘413 patent (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.
`
`B.
`
`Identification of Challenge Under 37 C.F.R. § 42.104(b) and Relief
`Requested
`
`The precise relief requested by Petitioner is that claims 1, 4, 9, 10, and 13 of
`
`the ‘413 Patent be found unpatentable.
`
`C. Claims for Which Inter Partes Review Is Requested
`
`Pursuant to 37 C.F.R. § 42.104(b)(1), Petitioner requests inter partes review
`
`of claims 1, 4, 9, 10, and 13 of the ‘413 Patent.
`
`D. 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 (Ex. 1003), 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.
`
`
`
`12
`
`

`

`
`
`§ 314(a). Inter partes review is requested in view of the following references and
`
`specific grounds for rejection under 35 U.S.C. §§ 102 and 103.
`
`Grounds
`Claims 1 and 13 are anticipated by US 5,527,292 (“Adams ‘292”)
`Claims 1, 4, 9, 10 and 13 are obvious over Adams ‘292 in view of
`knowledge of one of ordinary skill in the art
`Claims 1, 4, 9, 10 and 13 are obvious over Adams ‘292 in view of US
`5,776,141 (“Klein”)
`Claims 1, 4, 9, 10 and 13 are obvious over Adams ‘292 in view of US
`7,232,452 (“Adams ‘452”)
`Claims 1, 4, 9, 10 and 13 are obvious over Adams ‘292 in view of US Pub.
`2004/0236215 (“Mihara”)
`Claims 1, 4, 9, 10 and 13 are obvious over Adams ‘292 in view of US
`5,328,472 (“Steinke”)
`Claim 13 is obvious over Adams ‘292 in view of knowledge of one
`ordinary skill in the art
`Claim 13 is obvious over Adams ‘292 in view of “New Method to
`Increase a Backup Support of a 6 French Guiding Coronary Catheter,”
`2004, Takahashi Online Article (“Takahashi”)
`
`No.
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`
`
`Petitioner reserves the right to present new arguments and prior art
`
`references if the Patent Owner moves to amend the challenged claims.
`
`E. Construction Of The Challenged Claims
`
`Pursuant to 37 C.F.R. § 42.100(b), the claims subject to inter partes review shall
`
`receive the “broadest reasonable construction in light of the specification of the
`
`patent in which [they] appear[].” See 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
`
`
`
`13
`
`

`

`
`
`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 reasonable
`
`interpretation (“BRI”) in light of the patent specification, including their plain and
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`ordinary meaning to the extent such a meaning could be determined by a skilled
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`artisan.1
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`1.
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`“rail structure without a lumen”
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`Because the ‘413 patent does not disclose any structure for the “rail structure
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`without a lumen” limitation of independent claim 1, it is invalid under 35 U.S.C.
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`§ 112, ¶ 2. The word “rail” appears in the specification of the ‘413 patent only
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`twice. First, the Summary of the Invention refers to a “guidewire rail segment,”
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`defined as “permit[ing] delivery without blocking the use of the guide catheter.”
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`(Exh. 1001, 2:62). Second, Fig. 17 is described as “a plan view of a coaxial guide
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`catheter having a longer rail segment,” without any guidance as to which portion(s)
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`of Figure 17 constitute the “rail segment.” Neither of these references discloses any
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`1 Petitioner reserves the right to challenge the validity of the ‘413 patent claims
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`based on a failure to comply with § 112 ¶¶ 1, 2, and 6, in any proceeding.
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`meaning for “rail” in the claim term “rail structure without a lumen.” (Exh. 1003,
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`¶ 67). Moreover, nothing in the specification suggests that the rail structure
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`consists of the “tapered inner catheter,” “full circumference portion,” “cutout
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`potion,”
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`“reinforced portion,”
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`“hemicylindrical portion,”
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`“second
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`full
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`circumference portion,” “arcuate portion,” “braid or coil reinforcement,” “most
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`proximal portion of braid or coil reinforcement,” “relief cut,” “hemi-tube portion,”
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`“single cuts,” “double cuts,” “connector hub,” “funnel portion,” “grip portion,” to
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`name a few, nor would be so read by a POSA. (Id.)
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`However, 35 U.S.C. § 311(b) prevents Petitioner from challenging the
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`validity of an original claim based on a failure to comply with 35 U.S.C. § 112 in
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`this Petition. Accordingly, solely for the purpose of challenging the patentability of
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`independent claim 1 under 35 U.S.C. §§ 102 and 1032, and claims 4, 9, 10, and 13
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`depending therefrom, Petitioner submits that, a POSA would understand “rail
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`structure” to refer to a pushing or advancement structure. “Monorail” or rapid
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`exchange catheters are characterized by a relatively guide wire lumen; this cannot
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`be the “rail structure” for purposes of the claim, however, because the claimed
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`structure must be “without a lumen.” (Exh. 1003 ¶ 68). A POSA would therefore
`
`
`2 All references to 35 U.S.C. §§ 102 and 103 are to the pre-AIA version of the
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`United States Code, in accordance with the filing dates of the patents at issue.
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`15
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`understand the “rail structure” to be the other feature of rapid exchange catheters, a
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`stiffening element that makes the catheter sufficiently pushable to advance (even
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`though it is not being advanced over a guide wire throughout its entire length). (Id.
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`¶ 69). Accordingly, the term “rail structure without a lumen” can be construed for
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`purposes of this Petition to mean a “pushing or advancement structure without a
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`lumen.” (Id.)
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`2.
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`“interventional cardiology device(s)”
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`The specification of
`
`the ‘413 patent expressly defines
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`the
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`term
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`“interventional cardiology devices”: “For the purposes of this application, the term
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`‘interventional cardiology devices is to be understood to include but not be limited
`
`to guidewires, balloon catheters, stents and stent catheters.” (Exh. 1001, 1:23-26).
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`A person of ordinary skill in the art would understand the term “interventional
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`cardiology devices” to include other thin, flexible treatment devices used in
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`treating a blockages (occlusions) or narrowing (stenosis) in the arteries due to
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`atherosclerotic plaques or other lesions, such as embolic protection devices, such
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`as filters. (Exh. 1003 ¶ 70).
`
`F.
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`The Prior Art References
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`
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`16
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`As set forth below, the references upon which Petitioner relies all constitute
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`prior art to the ‘032 patent under §102(b), some of which also constitute prior art
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`under §102(a), as set forth below.3
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`
`
`1.
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`Adams ‘292
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`U.S. Patent No. 5,527,292 to Adams, et al. (“Adams ‘292”) (Exh. 1013)
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`matured from an application filed on September 9, 1994, prior to the earliest filing
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`date the benefit of which is claimed by the ‘032 patent and is therefore available as
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`prior art to the ‘032 patent under 35 U.S.C. § 102(b). Adams ‘292 describes a
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`guide catheter extension: “The invention is directed to the structure and use of a
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`distal extension (intravascular device) for a guide catheter” (Exh. 1013, 4:35-38;
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`Exh. 1003 ¶ 72), and discloses, inter alia:
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`An intravascular device having an elongated flexible tube sized for
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`insertion into a coronary vessel beyond a distal end of a guide
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`catheter. In use, the flexible tube has its proximal end within a guide
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`catheter and has its distal end extending to a treatment site in a
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`coronary artery. The device also including a push rod attached to a
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`proximal end of the flexible tube to facilitate placement of the flexible
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`tube within the coronary artery requiring treatment.
`
`
`3 All references to 35 U.S.C. §§ 102 and 103 are to the pre-AIA version of the
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`United States Code, in accordance with the filing date of the patent at issue.
`
`
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`17
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`(Exh. 1013 at Abstract). A benefit of the device disclosed in Adams ‘292 is the
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`ability to extend the flexible tube beyond the distal tip of the guide catheter so that
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`it is deep-seated beyond the ostium to anchor the guide catheter during treatment:
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`A proximal end of the flexible tube 32 is advanced so that a
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`significant portion of the flexible tube 32 extends into the artery
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`beyond the distal end of the guide catheter 12 to secure the guide
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`catheter 12 at the coronary ostium for guiding a coronary treatment
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`device into the arteries beyond….
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`(Exh. 1013, 9:12-24; see Exh. 1003 ¶¶ 31 and 72).
`
`2. Klein
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`U.S. Patent No. 5,776,141 to Klein (“Klein”) (Exh. 1005) matured from an
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`application filed on August 26, 1996, prior to the earliest filing date the benefit of
`
`which is claimed by the ‘032 patent and, thus, qualifies as prior art under §102(b).
`
`Klein discloses a delivery catheter having a tubular catheter body with a skived
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`proximal opening sized to receive a balloon catheter and a proximal shaft attached
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`to the proximal end of the tubular catheter body. (Exh. 1003 ¶ ¶ 33 and 75).
`
`3.
`
`Adams ‘452
`
`U.S. Patent No. 7,232,452 to Adams (“Adams ‘452”) (Exh. 1015) matured
`
`from an application filed on July 12, 2002, prior to the earliest filing date the
`
`benefit of which is claimed by the ‘032 patent, and thus qualifies as prior art under
`
`§ 102(b). The Adams ‘452 patent discloses a guide seal that “comprises an
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`elongate body defining an interior cavity which, when deployed in a vessel, is large
`
`
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`18
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`enough to allow passage of a catheter used to deliver … an expandable filter or
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`balloon.” (Exh. 1015, 8:47-50; Exh. 1003 ¶¶ 34 and 78). Adams ‘452 further
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`discloses “A proximal wire or other control means….” (Exh. 1013, 8:27-30). The
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`proximal opening of the guide seal 20 is skived or cut at an angle, forming an
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`opening that extends for a distance along the longitudinal axis and which is
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`accessible from a side transverse to the longitudinal axis. (Exh. 1003 ¶ 78). The
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`guide seal 20 receives an interventional device (the delivery catheter 17) while the
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`proximal portion of the guide seal 20 remains within the lumen of the guide
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`catheter 10. (Id. ¶ 34).
`
`4. Mihara
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`Patent Application Publication No. US 2004/0236215 A1 to Mihara, et al.
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`(“Mihara”) (Ex. 1040) was filed on March 12, 2004, prior to the earliest filing date
`
`the benefit of which is claimed by the ‘413 patent and, thus, qualifies as prior art
`
`under § 102(b). Mihara discloses “a linear wire” and “a tubular body placed on a
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`distal end side of the wire allowing a guide wire to be inserted through its hollow
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`portion.” (Exh.1040, ¶¶ [0013], [0014]). The proximal opening to the hollow tube
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`is skived or cut at an angle. (Id., FIG. 2).
`
`5.
`
`Steinke
`
`U.S. Patent No. 5,328,472 to Steinke (“Steinke”) (Ex. 1016) matured from
`
`an application filed on July 27, 1992, prior to the earliest filing date the benefit of
`
`
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`19
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`
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`which is claimed by the ‘032 patent and, thus, qualifies as prior art under § 102(b).
`
`Steinke discloses “a catheter which allows rapid exchange” where the proximal
`
`end of the inner lumen tubing is skived at an angle, forming an opening that
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`extends for a distance along the longitudinal axis and which is accessible from a
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`side transverse to the longitudinal axis. (Exh. 1016, 3:1-2; Exh. 1003, ¶ 35)
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`6.
`
`Takahashi
`
`Takahashi, New Method to Increase Back