BSC USP 8,142,413
`Exhibit 1003
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`Page 1 of 57
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`Attorney Docket No.:
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`In the Inter Partes Review of:
`Trial Number: To Be Assigned
`U.S. Patent No. 8,142,413
`Filed: May 3, 2006
`Issued:
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`Inventors: Howard Root, Greg Sutton,
`Jeffrey M. Welch, Jason M. Garrity
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`Assignee: Vascular Solutions, Inc.
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`Title: Coaxial Guide Catheter For
`Interventional Cardiology Procedures
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`DECLARATION BY RONALD SOLAR, PH.D. REGARDING U.S.
`PATENT NO. 8,142,413 UNDER 37 C.F.R. § 42.63(a)
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`1
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`Exhibit 1003
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`Page 1 of 57
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`Attorney Docket No.:
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`In the Inter Partes Review of:
`Trial Number: To Be Assigned
`U.S. Patent No. 8,142,413
`Filed: May 3, 2006
`Issued:
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`
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`Inventors: Howard Root, Greg Sutton,
`Jeffrey M. Welch, Jason M. Garrity
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`Assignee: Vascular Solutions, Inc.
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`Title: Coaxial Guide Catheter For
`Interventional Cardiology Procedures
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`DECLARATION BY RONALD SOLAR, PH.D. REGARDING U.S.
`PATENT NO. 8,142,413 UNDER 37 C.F.R. § 42.63(a)
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`Page 2 of 57
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`I, Ronald Jay Solar, Ph.D., do declare and state as follows:
`I.
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`Background and Experience
`1.
`I received my B.S. in Metallurgy and Materials Science from
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`Pennsylvania State University in 1972, and my Ph.D. in Metallurgy, Materials
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`Science and Biomaterials from University of Pennsylvania in 1976. My studies
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`focused on surgical implants.
`2.
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`Since graduation, virtually all of my experience has involved working
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`with various companies on the design, development, and testing of medical
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`devices, the vast majority of which have been in the field of interventional
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`cardiology.
`3.
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`Combined, I have over thirty-seven years of academic and industry
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`experience in all aspects of design, research, development, clinical testing,
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`regulation, patenting, manufacture, production, quality control and assurance,
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`marketing, and sales of medical devices. The predominant focus of my work in the
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`medical device industry has been in the design and development of interventional
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`cardiology devices within the peripheral and coronary vascular marketplace. I am a
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`named inventor of fifty U.S. patents on diagnostic and therapeutic catheters,
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`guidewires, vascular stents, and stent delivery systems, and I have extensive
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`experience with the design and functionality of such devices.
`4.
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`Attached to this declaration is a copy of my curriculum vitae at
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`Appendix A.
`5.
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`I am presently the President and Founder of Renaissance Biomedical,
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`Inc., which is a consulting firm focusing on all aspects of the medical device
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`industry, including research, design, technical, marketing, patent, clinical, and
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`regulatory issues.
`6.
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`I am not employed by, nor receiving grant support from, Boston
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`Scientific Corporation or its subsidiary, Boston Scientific Scimed, Inc. I am
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`receiving compensation for my involvement in this matter based on my standard
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`hourly consulting fees. I have no financial interest in the outcome of this case. A
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`listing of testimony that I have provided in prior proceedings and my compensation
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`is attached hereto as Appendix B.
`7.
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`I am competent to make this declaration based upon my personal
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`knowledge and technical expertise in the area of interventional cardiology devices
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`In preparing my opinions, I have considered the following materials:
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`U.S. Patent No. 8,142,413 (Exh. 1001 )
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`File History for U.S. Patent No. 8,142,413 (Exh. 1002)
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`U.S. Patent No. 8,048,032 (Exh. 1004)
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`U.S. Patent No. 8,292,850 (Exh. 1005)
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`and procedures.
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`File History for U.S. Patent No. 8,048,032 (Exh. 1006)
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`File History for U.S. Patent No. 8,292,850 (Exh. 1007)
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`U.S. Publication No. 2003/0195546 A1 to Solar, et al. (Exh. 1008)
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`U.S. Patent No. 6,638,2168 to Niazi (Exh. 1009)
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`U.S. Publication No. 2005/0004523 A1 to Osborne, et al. (Exh. 1010)
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`U.S. Publication No. 2004/0127927 to Adams (Exh. 1011)
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`U.S. Patent No. 6,338,725 B1 to Hermann et al. (Exh. 1012)
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`U.S. Patent No. 7,232,452 to Adams et al. (Exh. 1013)
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`U.S. Patent No. 5,776,141 to Klein et al. (Exh. 1014)
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`U.S. Patent No. 7,232,452 to Adams et al. (Exh. 1015)
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`U.S. Patent No. 5,328,472 to Steinke et al. (Exh. 1016)
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`Takahashi et al., “New Method to Increase a Backup Support of a 6
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`French Guiding Coronary Catheter,” Catherization and Cardiovascular
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`U.S. Patent No. 5,690,613 to Verbeek (Exh. 1018)
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`U.S. Patent No. 5,156,594 to Keith (Exh. 1019)
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`U.S. Patent No. 5,102,403 to Alt (Exh. 1020)
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`Interventions 63:452-456 (2004) (Exh. 1017)
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`Kucklick, Theodore R., The Medical Device R&D Handbook (2006)
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`(Exh. 1021)
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`Non-confidential publicly available versions of the following filings
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`and decisions in the ongoing District Court litigation:
`a. Amended Complaint filed by Vascular Solutions, Inc. in Vascular
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`Solutions, Inc. v. Boston Scientific Corporation, No. 13-cv-1172
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`(JRT-SER) (D. Minn.) (May 28, 2013) (Exh. 1022)
`b. Memorandum In Support of Motion for Preliminary Injunction filed
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`by Vascular Solutions, Inc. in Vascular Solutions, Inc. v. Boston
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`Scientific Corporation, No. 13-cv-1172 (JRT-SER) (D. Minn.)
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`(June 10, 2013) (Exh. 1023)
`c. Declaration of Howard Root In Support of Vascular Solution, Inc.’s
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`Motion for Preliminary Injunction with Non-Confidential Exhibits
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`filed in Vascular Solutions, Inc. v. Boston Scientific Corporation, No.
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`13-cv-1172 (JRT-SER) (D. Minn.) (June 10, 2013) (Exh. 1024)
`d. Boston Scientific Corporation Opposition to Vascular Solutions,
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`Inc.’s Motion for Preliminary Injunction filed in Vascular Solutions,
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`Inc. v. Boston Scientific Corporation, No. 13-cv-1172 (JRT-SER) (D.
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`Minn.) (July 28, 2013) (Exh. 1025)
`e. Non-Confidential Memorandum Opinion and Order Granting In Part
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`Plaintiff’s Motion for Preliminary Injunction filed in Vascular
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`Solutions, Inc. v. Boston Scientific Corporation, No. 13-cv-1172
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`(JRT-SER) (D. Minn.) (December 19, 2013) (Exh. 1026)
`f. Boston Scientific Corporation’s Motion for An Interim Stay and Stay
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`Pending Appeal, No. 2014-1185 (Fed. Cir.) filed December 27, 2013
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`(Exh. 1027)
`g. Vascular Solutions, Inc.’s Opposition to Boston Scientific
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`Corporation’s Motion for An Interim Stay and Stay Pending Appeal,
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`No. 2014-1185 (Fed. Cir.) filed January 3, 2014 (Exh. 1028)
`h. Boston Scientific Corporation’s Non-Confidential Opening Brief, No.
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`2014-1185 (Fed. Cir.) filed January 7, 2014 (Exh. 1029)
`i. Vascular Solutions, Inc.’s Non-Confidential Responsive Brief, No.
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`2014-1185 (Fed. Cir.) filed January 29, 2014 (Exh. 1030)
`j. Declaration of Anthony Vrba In Support of Boston Scientific
`Opposition to Motion for Preliminary Injunction filed in Vascular
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`Solutions, Inc. v. Boston Scientific Corporation, No. 13-cv-1172
`(JRT-SER) (D. Minn.) (July 8, 2013) (Exh. 1031)
`k. Boston Scientific Corporation’s Reply Brief, No. 2014-1185 (Fed.
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`Cir.) filed February 3, 2014 (Exh. 1032)
`l. Transcript of Oral Argument Proceedings held on April 8, 2014 (Fed.
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`Cir.) (Exh. 1033)
`m. Federal Circuit Order Vacating Preliminary Injunction (April 15,
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`2014) (Exh. 1034)
`n. Joint Claim Construction Statement filed in Vascular Solutions, Inc. v.
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`Boston Scientific Corporation, No. 13-cv-1172 (JRT-SER) (D. Minn.)
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`(February 21, 2014) (Exh. 1035)
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`U.S. Patent No. 6,997,908 B2 to Carrillo, Jr., et al. (Exh. 1036)
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`Monorail Piccolino Publication, Introducing the Schneider
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`U.S. Publication No. 2002/0165598 A1 to Wahr et al. (Exh. 1038)
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`U.S. Patent No. 5,267,958 to Buchbinder et al. (Exh. 1039)
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`MONORAIL-GEX Guidewire Exchange Catheter Brochure (Exh. 1037)
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`U.S. Publication No.2004/0236215 A1to Mihara et al. (Exh. 1040)
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`portions of the Manual of Patent Examining Procedure (MPEP),
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`including Sections 2131, 2141-2145;
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`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), and the MPEP
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`sections cited therein.
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`The documents I have reviewed are reflected in my analysis.
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`II.
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`Summary of Patent, Prior Art, and Analysis
`A. Overview of the Relevant Technology
`8.
`The claims of U.S. Patent No. 8,142,413 (“the ‘413 patent”)
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`(Exh. 1001) are directed to the field of interventional cardiology procedures, such
`as the treatment of obstructive coronary artery disease. (Id., 1:7-36.) During such
`procedures, physicians deploy thin, flexible treatment devices, such as guidewires,
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`balloon catheters, filters, stents, stent catheters, or other devices to treat a blockage
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`(occlusion) or narrowing (stenosis) in the arteries due to atherosclerotic plaques or
`other lesions. (Id.) 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
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`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
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`open into the coronary arteries), but is too wide for advancement beyond either
`coronary ostium. (Id.) The ‘413 patent is directed to methods for delivering an
`apparatus through a standard guide catheter for extension beyond the ostium to
`provide back up support—i.e., to prevent the guide catheter from being dislodged
`during the procedure. (See id., 2:45-49.)
`B. Overview of United States Patent No. 8,142,413
`9.
`The ‘413 patent, filed as U.S. App. Serial No. 12/824,734 on May 3,
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`2006, is entitled “Coaxial Guide Catheter for Interventional Cardiology
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`Procedures,” and includes 14 method claims (Exh. 1001). For purposes of this
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`declaration only, I have been asked to assume that the priority date of the ‘413
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`patent is May 3, 2006, the filing date of the ‘032 patent.
`10. The specification of the ‘413 patent describes it as relating “generally
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`to catheters used in interventional cardiology procedures,” and “[m]ore
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`particularly, ... apparatus for increasing backup support for catheters inserted into
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`the coronary arteries of the aorta.” (Exh. 1001, 1:13-17.)
`11. The full text of independent claim 1 of the ‘413 patent is set forth
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`below:
`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:
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`inserting the standard guide catheter into a first artery over a
`guidewire, the standard guide catheter having a distal end;
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`positioning the distal end of the standard guide catheter in a
`branch artery that branches off from the first artery;
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`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,
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`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;
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`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
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`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
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`cardiology device through and beyond a lumen of the flexible tip
`portion into contact with or past a lesion in the second artery.
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`12. Claim 4 (which depends from claim 1) adds the step of “selecting the
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`substantially rigid portion of the coaxial guide catheter such that it comprises a
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`cylindrical portion and a partially cylindrical portion defining an opening along a
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`side thereof.”
`13. Claim 9 (which depends from claim 1) adds the step of “extending the
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`interventional cardiology device through a proximal side opening defined by the
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`proximal portion of the tubular structure and extending for a distance along the
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`longitudinal axis of the proximal portion of the tubular structure while the
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`proximal portion remains within the lumen of the guide catheter.”
`14. Claim 10 (which depends from claim 9) adds the steps of “extending
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`the interventional cardiology device through the proximal side opening; advancing
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`the interventional cardiology device through structure defining a full circumference
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`portion; and advancing the interventional cardiology device through structure
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`defining a partially cylindrical portion.”
`15. Claim 13 (which depends from claim 1) adds the step of “selecting the
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`cross-sectional inner diameter of the coaxial lumen of the tubular structure to be
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`not more than one French smaller than the cross-sectional inner diameter of the
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`guide catheter.”
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`C. Background of Art
`16. The Field of the Invention “relates generally to catheters used in
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`interventional cardiology procedures,” and “[m]ore particularly ... apparatus for
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`increasing backup support for catheters inserted into the coronary arteries from the
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`aorta.” (Exh. 1001, 1:13-17.) The specification of the ‘413 patent admits that
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`inserting an inner guide catheter device within and through a standard guide
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`catheter (coaxially) to provide backup support during interventional cardiology
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`procedures was not new at the time of the ‘413 patent. Moreover, by the filing date
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`of ‘032 patent, the priority date of the ‘413 patent, existing catheter technology
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`routinely employed shortened flexible distal tubes for the receipt of an
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`interventional cardiology device known as a guidewire. The design of the proximal
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`opening in such catheters was angled or “skived.”
`17. Broadly speaking, there were two basic catheter designs available by
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`2006: “over the wire” catheters and “rapid exchange” (or “monorail”) catheters. In
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`an over the wire catheter, the guide wire remains inside the catheter for the entire
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`length of the catheter as depicted in the image below:
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`Guidewire
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`18.
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`In contrast, a rapid exchange catheter is delivered over a guidewire,
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`but the flexible tube that defines the device’s guidewire lumen is shorter than the
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`full length of the catheter and passes over only part of the wire. The below image
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`depicts a rapid exchange catheter, showing the guidewire inside the catheter for
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`only a portion of the catheter’s length. I understand that both of these illustrations
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`were used in the declaration of named inventor Howard Root that was submitted
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`on behalf of the Patent Owner in the pending litigation. (Exh. 1024, 11-12.)
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`Guidewire
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`19.
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`In using over the wire catheters, physicians must rely on an assistant
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`to help them deliver the guidewire—since it must be long enough to run the entire
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`length of both catheters. Rapid exchange catheters were, therefore, considered
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`advantageous because their shortened guidewire lumen permitted the use of shorter
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`guidewires for more efficient delivery and exchange.
`20. There were countless disclosures of skived proximal openings existing
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`in the art prior to the filing of the ‘032 patent, particularly due to the prevalence of
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`such teachings in rapid exchange balloon catheter patents and publications. A few
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`prior art disclosures that are demonstrative of the pervasiveness of such teachings
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`in the art include: U.S. Patent No. 5,690,613 (“Verbeek”) (Exh. 1018) directed to
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`“a shaft transition section for a rapid exchange high pressure balloon catheter”
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`wherein the proximal portion of the guidewire lumen is skived at an angle.
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`Verbeek expressly teaches to: “Skive 95 the proximal end of the inner lumen
`tubing 70 at an angle of approximately 10 degrees for a length of 2mm.” (Id., 1:6-
`9, 6:9-11.)
`21.
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`In 1990, U.S. Patent No. 5,102,403 (“Alt”) (Exh. 1020) also disclosed
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`a catheter “of the type riding on a guide wire only at a short distal end portion”
`(Id., 2:63-65), including an express disclosure and clear depiction of a proximal
`side opening having both full circumference and hemicylindrical portions through
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`which a guidewire is received. (Id. at Figs. 4, 7.) Alt was directed to a catheter that
`includes an outer wall that changes gradually while passing through successive
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`configurations at the more distal end. The substantially cylindrical outer wall
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`becomes grooved to guide a guide wire alongside toward the interior of the
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`catheter without any significant bending of the wire. This groove becomes a
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`crescent-shaped wall-lumina configuration which partially encompasses the guide
`wire before becoming cylindrical to surround the guide wire. (Id.)
`22. A similarly gradual guidewire transition design was also described in
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`1990 by Keith (U.S. Patent No. 5,156,594) (Exh. 1019), which incorporated
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`hypodermic needle tubing to improve pushing forces. The Keith patent focused on
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`improving the transition zone at the proximal guide wire lumen opening by
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`incorporating a metallic tube formed into a crescent shape connected to a metallic
`spring. (Id., 3:59-4:52.)
`23.
`Indeed, as early as 1987, in an article by Dr. Tasilo Bonzel—
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`submitted by Patent Owner in the ongoing litigation as an exhibit to the
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`Declaration of Howard Root (a named inventor of the ‘413 patent)—there is a clear
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`depiction of a skived proximal opening to a lumen for the receipt of a guidewire.
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`(Exh. 1024 at Exhibit 1 thereto.)
`24. As such, replacing the use of a full length catheter with a skived short
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`distal guidewire lumen tube segment was well known in the art well before the
`‘413 patent as a standard feature of rapid exchange catheters. See also, Carillo Jr.
`(Exh. 1036, at least Figures 1A-E show a catheter having proximal side opening
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`defining a full circumference portion and a partially cylindrical portion );
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`Schneider, Inc., Product Brochure for Monorail® GEXTM (Exh. 1037, Figure
`depicts side opening), Wahr et al. (Exh. 1038, [105] (“The distal and proximal
`ends of the expanded evacuation head 232 may be angled relative to its
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`longitudinal axis...”);; Claim 145 (“An evacuation sheath assembly, comprising: an
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`elongated tube defining an evacuation lumen having open proximal and distal ends
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`...wherein the open proximal end of the evacuation lumen is angled.”), and
`Buchbinder et al. (Exh. 1041, Fig. 4 shows a catheter with a proximal opening of
`the guide wire lumen cut at an angle or skived.)
`25. Even outside of rapid exchange, skiving was well known in the art as,
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`from a manufacturing standpoint, one of the most basic and efficient designs for
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`crafting an opening in the lumen of a catheter, and a common technique for
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`controlling the flexibility of a device in areas where breakage or kinking were
`likely to occur. See, e.g., Kucklick, Theodore R., Medical Device R and D
`Handbook (Nov. 21, 2005) (Exh. 1021, at p. 117).
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`III. One of Ordinary Skill in the Art
`26.
`I understand that the factors considered in determining the ordinary
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`level of skill in the art include the level of education and experience of persons
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`working in the field; the types of problems encountered in the field; and the
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`sophistication of the technology.
`27.
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`In my opinion, a person of ordinary skill in the art (“POSA”) at the
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`time of the alleged invention of the ‘032 patent, the priority date of the ‘413 patent
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`would have been someone with at least the equivalent of a medical degree from an
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`accredited institution (usually denoted in this country as a M.D. degree) or
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`someone with the equivalent of a masters degree from an accredited institution
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`(usually denoted in this country as an M.S. degree) in biomedical engineering. The
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`person must have at least three years of experience working as an interventional
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`cardiologist, interventional radiologist, cardiothoracic surgeon, interventionalist, or
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`biomedical engineer or biomedical device designer and/or manufacturer. Extensive
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`experience and technical training might substitute for educational requirements,
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`while advanced degrees might substitute for experience.
`28. A POSA would have a detailed understanding of the prior art, would
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`have been able to draw inferences from the prior art, and would have had the
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`ability to identify optimal combinations of device shapes and configurations found
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`in the prior art for a particular application.
`29.
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`In 2006, I would have exceeded the level of skill required, and I am in
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`a position to opine on the understanding of a person of ordinary skill in the art.
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`IV. Summary of Prior Art References
`30.
`I have evaluated references in connection with this proceeding that
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`address the elements of the claims of the ‘413 patent. All cited references fall in
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`the field of art of the invention (interventional cardiology procedures) (Exh. 1001,
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`1:44-49), or are reasonably pertinent to such art. They are also directed to the same
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`problems that the elements of the claimed invention address. A summary of the
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`references and the elements to which the references apply follows.
`31. U.S. Patent No. 5,527,292 to Adams (“Adams ‘292”) (Exh. 1013) is
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`directed to “the structure and use of a distal extension (intravascular device) for a
`guide catheter,” (Exh. 1013, 4:35-38), and discloses, inter alia: “[a]n intravascular
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`device having an elongated flexible tube sized for insertion into a coronary vessel
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`beyond a distal end of a guide catheter. In use, the flexible tube has its proximal
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`end within a guide 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 proximal end of
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`the flexible tube to facilitate placement of the flexible tube within the coronary
`artery requiring treatment.” (Id., Abstract.) Adams ‘292 describes that a benefit of
`its disclosed device is the ability to extend the flexible tube beyond the distal tip of
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`the guide catheter so that it is seated deep enough beyond the ostium to anchor the
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`position of the guide catheter during treatment: “A proximal end of the flexible
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`tube 32 is advanced so that a significant portion of the flexible tube 32 extends into
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`the artery 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 device into the
`arteries beyond….” (Id., 9:12-24.)
`32.
`I have been informed by counsel that Adams ‘292 is prior art to the
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`ʼ413 patent under §102(b) because it was published and patented more than one
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`year prior to the May 6, 2006 filing date of the ʼ032 patent, the earliest priority
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`date of the ‘413 patent. Adams ‘292 teaches all of the elements of independent
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`claim 1 and dependent claim 13, as well as portions of dependent claims 4, 9, and
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`10. Adams ‘292 also provides substantial disclosure of the “not more than one
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`French” range limitations of dependent claim 13.
`33. U.S. Patent No. 5,776,141 to Klein (“Klein”) (Exh. 1014) is directed
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`to a delivery catheter having a tubular catheter body with a skived proximal
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`opening sized to receive a balloon catheter. I have been informed by counsel that
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`Klein is prior art to the ʼ413 patent under §102(b) because it was published and
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`patented more than one year prior to the May 6, 2006 filing date of the ʼ032 patent,
`
`the earliest priority date of the ‘413 patent. Klein generally teaches the proximal
`
`side opening elements of challenged dependent claims 4, and 10, as well as
`
`portions of each of the other elements of independent claim 1.
`34. U.S. Patent No. 7,232,452 to Adams (“Adams ‘452”) (Exh. 1015) is
`
`directed to a guide seal that “comprises an elongate body defining an interior
`
`cavity which, when deployed in a vessel, is large enough to allow passage of a
`catheter used to deliver … an expandable filter or balloon.” (Id., 8:47-50.) The
`proximal opening of the guide seal 20 is skived or cut at an angle, forming an
`
`opening that extends for a distance along the longitudinal axis and which is
`
`accessible from a side transverse to the longitudinal axis. The guide seal 20
`
`receives an interventional device (the delivery catheter 17 while the proximal
`portion of the guide seal 20 remains within the lumen of the guide catheter 10. (Id.,
`Id., Fig. 2C.) I have been informed by counsel that Adams ‘452 is prior art to the
`ʼ413 patent under §102(b) because it was published and patented more than one
`
`year prior to the May 6, 2006 filing date of the ʼ032 patent, the earliest priority
`
`date of the ‘413 patent. Adams ‘452 generally teaches the proximal side opening
`
`elements of challenged dependent claims 4 and 10, as well as portions of each of
`
`the other elements of independent claim 1.
`35. U.S. Patent No. 5,328,472 to Steinke (“Steinke”) (Exh. 1016) is
`
`directed to “a catheter which allows rapid exchange” where the proximal end of the
`
`inner lumen tubing is skived at an angle, forming an opening that extends for a
`
` 17
`
`
`
`Page 18 of 57
`
`distance along the longitudinal axis and which is accessible from a side transverse
`to the longitudinal axis. (Id., 3:1-2.) I have been informed by counsel that Steinke
`is prior art to the ʼ413 patent under §102(b) because it was published and patented
`
`more than one year prior to the May 6, 2006 filing date of the ʼ032 patent, the
`
`earliest priority date of the ‘413 patent. Steinke generally teaches the proximal side
`
`opening elements of challenged dependent claims 4 and 10, as well as portions of
`
`each of the other elements of independent claim 1.
`36. Takahashi, New Method to Increase Backup Support of a 6 French
`
`Guiding Coronary Catheter, Catheterization and Cardiovascular Interventions
`
`63:452-456 (2004) (“Takahashi”) (Ex. 1017) is directed to a method for deep-
`
`seating a guide catheter beyond the ostium for purposes of providing backup
`
`support during interventional cardiology procedures. I have been informed by
`
`counsel that Takahashi is prior art to the ʼ032 patent under §102(b) because it was
`
`published more than one year prior to the May 6, 2006 filing date of the ʼ032
`
`patent, the earliest priority date of the ‘413 patent. The method disclosed by
`
`Takahashi involves the insertion of a 5 French guide catheter extension through a 6
`
`French guide catheter, whereby the resulting difference in diameters is not more
`
`than one French. Accordingly, this disclosure of Takahashi is within the claimed
`
`range of dependent claim 13.
`
`V.
`
`Summary of Opinions
`37. A number of prior art references, including those discussed below,
`
`show that the various claim elements of the ‘413 patent were well known both
`
`individually and in combination in the prior art. To the extent that any of the claim
`
` 18
`
`
`
`Page 19 of 57
`
`limitations are not explicitly disclosed in one reference, such limitations could be
`
`found by one of ordinary skill in one or more of the other references. As such, in
`
`my opinion, the asserted claims would have been in the possession of or obvious to
`
`one of ordinary skill in the art from the disclosures in one or more of certain prior
`art references.
`A. Claims 1 and 13 are anticipated in view of Adams ‘292 under
`§ 102(b)
`It is my opinion that each of independent claim 1 and dependent
`
`38.
`
`claim 13 are invalid as anticipated under § 102(b) over Adams ‘292. I address each
`
`element of those claims in Paragraphs 92-108 of this Declaration.
`39. The Adams ‘292 reference is analogous art to the ‘413 patent at least
`
`because it is within the same field of endeavor as the invention of the ‘413 patent
`
`or was acknowledged by the Patent Owner to be in an analogous field. Further, the
`
`Adams ‘292 is reasonably pertinent to the problem addressed in the ‘413 patent
`
`claims. I address the issue of analogous art in Paragraphs 71-72.
`
`B. Claims 1, 4, 9 and 10 obvious over Adams ‘292 In View Of The
`Knowledge of One of Skill In The Art
`It is my opinion that each of claims 1,4, 9, and 10 are invalid as
`
`40.
`
`obvious under § 103(a) over Adams ‘292 in further view of Klein. I address each
`
`element of those claims in Paragraphs 109-110 of this Declaration..
`41. One of ordinary skill in the art would have been motivated to modify
`
`Adams ‘292 in view of that which was well known in the art to achieve the alleged
`
` 19
`
`
`
`Page 20 of 57
`
`inventions of the ‘413 patent. The issue of motivation is addressed in Paragraphs
`
`89-91 and 109-10. I address the relevant level of skill in Paragraphs 27-29.
`
`C. Claims1, 4, 9, 10 and 13 are rendered obvious under § 103(a) over
`Adams ‘292 in view of Klein
`It is my opinion that each of claims 1,4, 9, 10 and 13 are invalid as
`
`42.
`
`obvious under § 103(a) over Adams ‘292 in further view of Klein. I address each
`
`element of those claims in Paragraphs 111-114 of this Declaration.
`43. The Klein reference is analogous art to the ‘413 patent in that it falls
`
`within the same field of endeavor as the invention of the ‘413 patent. Further, the
`
`reference is reasonably pertinent to the alleged problem addressed by the ‘413
`
`patent. I address the issue of analogous art in Paragraphs 75-77.
`44. One of ordinary skill in the art would have been motivated to modify
`
`Adams ‘292 with the teachings of Klein to achieve the alleged inventions of the
`
`‘413 patent. The issue of combinability is addressed in Paragraphs 89-91 and 109-
`
`10.
`
`D. Claims 1, 4, 9, 10 and 13 are rendered obvious under § 103(a) over
`Adams ‘292 in view of Adams ‘452
`It is my opinion that each of claims 1, 4, 9, 10 and 13 are invalid as
`
`45.
`
`obvious under § 103(a) over Adams ‘292 in further view of Adams ‘452. I address
`
`each element of those claims in Paragraphs 115-18 of this Declaration.
`46. The Adams ‘452 reference is analogous art to the ‘413 patent in that it
`
`falls within the same field of endeavor as the invention of the ‘413 patent. Further,
`
` 20
`
`
`
`Page 21 of 57
`
`the reference is reasonably pertinent to the alleged problem addressed by the ‘413
`
`patent. I address the issue of analogous art in Paragraphs 78-79.
`47. One of ordinary skill in the art would have been motivated to modify
`
`Adams ‘292 with the teachings of Adams ‘452 to achieve the alleged inventions of
`
`the ‘413 patent. The issue of combinability is addressed in Paragraphs 89-91 and
`
`109-10.
`
`E. Claims 1, 4, 9, 10 and 13 Are Obvious Under 35 U.S.C. §103 Over
`Adams ‘292 In Vi
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