BSC USP 8,048,032B
`Exhibit 1003
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`Page 1 of 40
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In the Inter Partes Review of:
`U.S. Patent No. 8,048,032
`Filed: May 3, 2006
`Issued:
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`Trial Number: To Be Assigned
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`Attorney Docket No.:
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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. 8,048,032 UNDER 37 C.F.R. § 42.63(a)
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`Exhibit 1003
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`Page 1 of 40
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In the Inter Partes Review of:
`U.S. Patent No. 8,048,032
`Filed: May 3, 2006
`Issued:
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`
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`Trial Number: To Be Assigned
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`Attorney Docket No.:
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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. 8,048,032 UNDER 37 C.F.R. § 42.63(a)
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`I, Ronald Jay Solar, Ph.D., do declare and state as follows:
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`I.
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`Background and Experience
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`1.
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`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.
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`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.
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`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.
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`4.
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`Attached to this declaration is a copy of my curriculum vitae at
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`Appendix A.
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`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.
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`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.
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`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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`and procedures. In preparing my opinions, I have considered the following
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`materials:
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`1010)
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`U.S. Patent No. 8,048,032 to Root, et al. (Exh. 1001 )
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`File History for U.S. Patent No. 8,048,032 (Exh. 1002)
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`U.S. Patent No. 8,292,850 to Root, et al. (Exh. 1004)
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`U.S. Patent No. 8,142,413 to Root, et al. (Exh. 1005)
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`File History for U.S. Patent No. 8,292,850 (Exh. 1006)
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`File History for U.S. Patent No. 8,142,413 (Exh. 1007)
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`U.S. Publication No. 2004/0236215 A1 to Mihara et al. (Exh. 1009)
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`Translation of Japanese Patent Application No. 2003-070808 (Exh.
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`U.S. Patent No. 5,527,292 to Adams et al. (Exh. 1011)
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`U.S. Publication No. 2003/0195546 A1 to Solar, et al. (Exh. 1012)
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`U.S. Patent No. 6,638,268 to Niazi (Exh. 1013)
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`U.S. Publication No. 2005/0004523 A1 to Osborne, et al. (Exh. 1014)
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`U.S. Publication No. 2004/0127927 to Adams (Exh. 1015)
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`U.S. Patent No. 6,338,725 B1 to Hermann et al. (Exh. 1016)
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`U.S. Patent No. 5,776,141 to Klein et al. (Exh. 1017)
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`U.S. Patent No. 7,232,452 to Adams et al. (Exh. 1018)
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`U.S. Patent No. 5,328,472 to Steinke et al. (Exh. 1019)
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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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`Interventions 63:452-456 (2004) (Exh. 1020)
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`U.S. Patent No. 5,690,613 to Verbeek (Exh. 1021)
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`U.S. Patent No. 5,156,594 to Keith (Exh. 1022)
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`U.S. Patent No. 5,102,403 to Alt (Exh. 1023)
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`Kucklick, Theodore R., The Medical Device R&D Handbook (2006)
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`(Exh. 1024)
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`Non-confidential publicly available versions of the following filings
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`and decisions in the ongoing litigation:
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`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. 1025)
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`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. 1026)
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`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. 1027)
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`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. 1028)
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`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. 1029)
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`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. 1030)
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`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. 1031)
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`h. Boston Scientific Corporation’s Non-Confidential Opening Brief, No.
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`2014-1185 (Fed. Cir). filed January 7, 2014 (Exh. 1032)
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`i. Vascular Solutions, Inc.’s Non-Confidential Responsive Brief, No.
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`2014-1185 (Fed. Cir). filed January 29, 2014 (Exh. 1033)
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`j. Boston Scientific Corporation’s Reply Brief, No. 2014-1185 (Fed.
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`Cir). filed February 3, 2014 (Exh. 1034)
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`k. Transcript of Oral Argument Proceedings held on April 8, 2014 (Fed.
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`Cir). (Exh. 1035)
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`l. Federal Circuit Order Vacating Preliminary Injunction (April 15,
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`2014) (Exh. 1036)
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`m. 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. 1037)
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`U.S. Patent No. 6,997,908 B2 to Carrillo, Jr., et al. (Exh. 1038)
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`Monorail Piccolino Publication, Introducing the Schneider
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`MONORAIL-GEX Guidewire Exchange Catheter Brochure (Exh. 1039)
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`U.S. Publication No. 2002/0165598 A1 to Wahr et al. (Exh. 1040)
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`U.S. Patent No. 5,267,958 to Buchbinder et al. (Exh. 1041)
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`Manual of Patent Examining Procedure (MPEP) Sections cited herein
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`KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, (2007);
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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
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`A. Overview of the Relevant Technology
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`8.
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`The claims of U.S. Patent No. 8,048,032 (“the ‘032 Patent”) (Exh.
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`1001) are directed to the field of interventional cardiology procedures, such as the
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`treatment of obstructive coronary artery disease. (See Exh. 1001, 1:7-36). During
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`such procedures, physicians deploy thin, flexible treatment devices, such as
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`guidewires, balloon catheters, filters, stents, stent catheters, or other devices to
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`treat a blockage (occlusion) or narrowing (stenosis) in the arteries due to
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`atherosclerotic plaques or other lesions. (Id). The physician introduces the
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`treatment device into the patient’s vascular system through the groin or wrist and
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`advances it to the site of a blockage to perform a procedure—such as the inflation
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`of a balloon or the placement of a stent—to relieve the blockage and restore blood
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`flow. Id. Often, to create a passage for such treatment devices, physicians insert a
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`“guide catheter” earlier in the procedure. (Id). In coronary interventions, this guide
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`catheter typically runs from the groin or wrist to one of the coronary ostia (two
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`openings in the aorta that open into the coronary arteries), but is too wide for
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`advancement beyond either coronary ostium. (Id). The ‘032 patent is directed to an
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`apparatus that is deliverable through a standard guide catheter for extension
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`beyond the ostium to provide back up support—i.e., to prevent the guide catheter
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`from being dislodged during the procedure. (See, e.g., Exh. 1001, 2:45-49).
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`B. Overview of United States Patent No. 8,048,032
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`9.
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`United States Patent No. 8,048,032 (“the ‘032 patent”), filed as U.S.
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`App. Serial No. 11/416,629 on May 3, 2006, is entitled “Coaxial Guide Catheter
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`for Interventional Cardiology Procedures,” and includes 22 device claims (Exh.
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`1001). For the purpose of this declaration only, I have been asked to assume that
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`the priority date of the ‘032 patent is May 3, 2006.
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`10. The specification of the ‘032 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, 1:7-11).
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`11. The full text of independent claim 1 of the ‘032 patent is set forth
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`below:
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`1. A device for use with a standard guide catheter, the standard
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`guide catheter having a continuous lumen extending for a
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`predefined length from a proximal end at a hemostatic valve to a
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`distal end adapted to be placed in a branch artery, the continuous
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`lumen of the guide catheter having a circular cross-sectional
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`inner diameter sized such that interventional cardiology devices
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`are insertable into and through the lumen to the branch artery, the
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`device comprising:
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`a flexible tip portion defining a tubular structure having a
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`circular cross-section and a length that is shorter than the
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`predefined length of the continuous lumen of the guide catheter,
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`the tubular structure having a cross-sectional outer diameter
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`sized to be insertable through the cross-sectional inner diameter
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`of the continuous lumen of the guide catheter and defining a
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`coaxial lumen having a cross-sectional inner diameter through
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`which interventional cardiology devices are insertable; and
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`a substantially rigid portion proximal of and operably connected
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`to, and more rigid along a longitudinal axis than, the flexible tip
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`portion and defining a rail structure without a lumen and having
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`a maximal cross-sectional dimension at a proximal portion that is
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`smaller than the cross-sectional outer diameter of the flexible tip
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`portion and having a length that, when combined with the length
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`of the flexible distal tip portion, defines a total length of the
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`device along the longitudinal axis that is longer than the length
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`of the continuous lumen of the guide catheter,
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`such that when at least a distal portion of the flexible tip portion
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`is extended distally of the distal end of the guide catheter, at least
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`a portion of the proximal portion of the substantially rigid portion
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`extends proximally through the hemostatic valve in common with
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`interventional cardiology devices that are insertable into the
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`guide catheter.
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`12. The other claims at issue in this proceeding that depend from claim 1
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`include claim 2 which effectively describes a functional use for the device of claim
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`1, without reciting any additional structural components. Specifically, claim 2
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`recites: “that the device assists in resisting axial and shear forces exerted by the
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`interventional cardiology device passed through and beyond the coaxial lumen that
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`would otherwise tend to dislodge the guide catheter from the branch artery.”
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`13. Claim 3 (which depends from claims 1 and 2) adds the element of a
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`“proximal side opening ... extending for a distance along the longitudinal axis” and
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`“transverse to the longitudinal axis”, and claim 4 (which depends from claims 1, 2,
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`and 3) adds the elements of a “structure defining a full circumference portion and
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`structure defining a partially cylindrical portion.”
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`14. Claim 8 (which depends from claim 1) adds the element that the “the
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`cross-sectional inner diameter of the coaxial lumen of the tubular structure is not
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`more than one French smaller than the cross-sectional inner diameter of the guide
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`catheter.”
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`15. The elements of independent claim 11 of the ‘032 patent include all
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`the limitations of claim 1. In addition to the limitations of claim 1, claim 11 also
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`includes the additional limitation of “a reinforced portion proximal to the flexible
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`tip portion.”
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`16.
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` Claim 13 (which depends from claim 11) adds the element of “the
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`substantially rigid portion further includ[ing] a partially cylindrical portion
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`defining an opening extending for a distance along a side thereof defined
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`transverse to a longitudinal axis ... the opening extending substantially along at
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`least a portion of a length of the substantially rigid portion.”
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`17. Claim 17 (which depends from claim 11) adds the element (identical
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`to claim 8) that the “the cross-sectional inner diameter of the coaxial lumen of the
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`tubular structure is not more than one French smaller than the cross-sectional inner
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`diameter of the guide catheter.”
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`C. Background of Art
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`18. 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, 1:7-11). The specification of the ‘032 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 ‘032 patent. Moreover, by the filing
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`date of ‘032 patent, existing catheter technology routinely employed shortened
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`flexible distal tubes for the receipt of an interventional cardiology device known as
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`a guidewire. The design of the proximal opening in such catheters was angled or
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`“skived.”
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`19. 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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`20.
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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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`(absent the annotations in red) were used in the declaration of named inventor
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`Howard Root that was submitted on behalf of the Patent Owner in the pending
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`litigation (Exh. 1027, 11-12).
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`Guidewire
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`21.
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`In using over the wire catheters, physicians have to rely on an
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`assistant to help them deliver the guidewire—since it must be long enough to run
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`the entire length of both catheters. Rapid exchange catheters were, therefore,
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`considered advantageous because their shortened guidewire lumen permitted the
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`use of shorter guidewires for more efficient delivery and exchange.
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`22. 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 given the prevalence of
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`such teachings in the art of rapid exchange balloon catheter patents and
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`publications. A few prior art disclosures that are demonstrative of the
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`pervasiveness of such teachings in the art include: U.S. Patent No. 5,690,613
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`(“Verbeek”) (Exh. 1021) directed to “a shaft transition section for a rapid exchange
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`high pressure balloon catheter” wherein the proximal portion of the guidewire
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`lumen is skived at an angle. Verbeek expressly teaches to: “Skive 95 the proximal
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`end of the inner lumen tubing 70 at an angle of approximately 10 degrees for a
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`length of 2mm.” (Exh. 1021, 1:6-9, 6:9-11).
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`23.
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`In 1990, U.S. Patent No. 5,102,403 (“Alt”) (Exh. 1023) also disclosed
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`a catheter “of the type riding on a guide wire only at a short distal end portion”
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`(Exh. 1023, 2:63-65), including an express disclosure and clear depiction of a
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`proximal side opening having both full circumference and hemicylindrical portions
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`through which a guidewire is received. (Id. at Figs. 4, 7). Alt was directed to a
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`catheter that includes an outer wall that changes gradually while passing through
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`successive configurations at the more distal end. The substantially cylindrical outer
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`wall 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
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`wire before becoming cylindrical to surround the guide wire. (Exh. 1023, 3:10-14;
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`4:36-51).
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`24. 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. 1022) 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
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`spring. (Exh. 1022, 3:59-4:52).
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`25. 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
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`‘032 patent as standard features of rapid exchange catheters. See also, Carillo Jr
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`(Exh. 1038, 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. 1039, Figure
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`depicts side opening), Wahr et al. (Exh. 1040, [105] (“The distal and proximal
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`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:
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`an elongated tube defining an evacuation lumen having open proximal and distal
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`ends . . .wherein the open proximal end of the evacuation lumen is angled.”), and
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`Buchbinder et al. (Exh. 1041, Fig. 4 shows a catheter with a proximal opening of
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`the guide wire lumen cut at an angle or skived).
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`26. 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
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`likely to occur. See, e.g., Kucklick, Theodore R., Medical Device R & D
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`Handbook (Nov. 21, 2005) (Exh. 1024, at p. 117).
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`III. One of Ordinary Skill in the Art
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`27.
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`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.
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`28.
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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 would have been someone with at
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`least the equivalent of a medical degree from an accredited institution (usually
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`denoted in this country as a M.D. degree) or someone with the equivalent of a
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`masters degree from an accredited institution (usually denoted in this country as an
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`M.S. degree) in biomedical engineering. The person must have at least three years
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`of experience working as an interventional cardiologist, interventional radiologist,
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`cardiothoracic surgeon, interventionalist, or biomedical engineer or biomedical
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`device designer and/or manufacturer. Extensive experience and technical training
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`might substitute for educational requirements, while advanced degrees might
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`substitute for experience.
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`29. 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.
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`30.
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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
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`31.
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`I have evaluated references in connection with this proceeding that
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`address the elements of the claims of the ‘032 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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`1:39-43), 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. U.S. Pub. No.
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`2004/0236215 (“Mihara”) (Exh. 1009) is an application published on
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`November 25, 2004, prior to the earliest filing date the benefit of which is claimed
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`by the ‘032 patent and, thus, qualifies as prior art under § 102(b). The Mihara
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`publication discloses a “catheter for penetrating a stenotic lesion occurred in a
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`lumen in a human body, including: a linear wire; and a tubular body placed on a
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`distal end side of the wire and allowing a guide wire to be inserted through its
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`hollow portion.” (Exh. 1009, Abstract).
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`32. Takahashi, New Method to Increase Backup Support of a 6 French
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`Guiding Coronary Catheter, Catheterization and Cardiovascular Interventions
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`63:452-456 (2004) (“Takahashi”) (Exh. 1020) is directed to a method for deep-
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`Page 16 of 40
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`seating a guide catheter beyond the ostium for purposes of providing backup
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`support during interventional cardiology procedures. I have been informed by
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`counsel that Takahashi is prior art to the ‘032 patent under §102(b) because it was
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`published more than one year prior to the May 6, 2006 filing date of the ‘032
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`patent. The method disclosed by Takahashi involves the insertion of a 5 French
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`guide catheter extension through a 6 French guide catheter, whereby the resulting
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`difference in diameters is not more than one French. Accordingly, this disclosure
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`of Takahashi is within the claimed range of dependent claims 8 and 17.
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`V.
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`Summary of Opinions
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`33. A number of prior art references, including those discussed below,
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`show that the various claim elements of the ‘032 patent were well known both
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`individually and in combination in the prior art. To the extent that any of the claim
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`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.
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`A. Claims 1, 2, 3, 4, 11 and 13 are anticipated in view of Mihara
`under § 102(b).
`
`34.
`
`It is my opinion that each of independent claims 1 and 11 and
`
`dependent claims 2, 3, 4, and 13 are invalid as anticipated under § 102(b) over
`
`Mihara. I address each element of those claims in Paragraphs 63-89 of this
`
`Declaration.
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`Page 17 of 40
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`35. The Mihara reference is analogous art to the ‘032 patent at least
`
`because it is within the same field of endeavor as the invention of the ‘032 patent.
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`Further, the Mihara is reasonably pertinent to the problem addressed in the ‘032
`
`patent claims. I address the issue of analogous art in Paragraphs 54-55.
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`B. Claims 1, 2, 3, 4, 11, and 13 are rendered obvious under § 103(a)
`over Mihara in view of the knowledge of one of skill in the art.
`
`36.
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`It is my opinion that each of claims 8 and 17 are invalid as obvious
`
`under § 103(a) over Mihara in further view of the knowledge of one of skill in the
`
`art at the time of the claimed invention. I address each element of those claims in
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`Paragraphs 33 and 61-62 of this Declaration.
`
`37. One of ordinary skill in the art would have been motivated to modify
`
`Mihara in view of what was well known in the art to achieve the alleged inventions
`
`of the ‘032 patent. The issue of motivation to modify is addressed in Paragraphs
`
`61-62 and 90. I address the relevant level of skill in the art at Paragraphs 27-30.
`
`C. Claims 8 and 17 are rendered obvious under § 103(a) over Mihara
`in view of the Takahashi article.
`
`38.
`
`It is my opinion that each of claims 8 and 17 are invalid as obvious
`
`under § 103(a) over Mihara in further view of the Takahashi article. I address each
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`element of those claims in Paragraphs 91-95 of this Declaration.
`
`39. The Takahashi article publication is analogous art to the ‘032 patent in
`
`that it falls within the same field of endeavor as the invention of the ‘032 patent.
`
`Further, the reference is reasonably pertinent to the alleged problem addressed by
`
`the ‘032 patent. I address the issue of analogous art in Paragraphs 56-58.
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` 17
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`Page 18 of 40
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`40. One of ordinary skill in the art would have been motivated to modify
`
`Mihara with the teachings of Takahashi to achieve the alleged inventions of the
`
`‘032 patent. The issue of combinability is addressed in Paragraphs 33, 61-62 and
`
`91-95.
`
`VI. Legal Principles Used In Analysis
`
`41.
`
`I understand that my analysis requires an understanding of the scope
`
`of the ‘032 claims. I understand that claims subject to inter partes review are given
`
`the “broadest reasonable construction in light of the specification of the patent in
`
`which it appears.” 42 C.F.R. § 42.100(b).
`
`42.
`
`I understand that a claim is invalid if it is anticipated or obvious. I
`
`understand that anticipation of a claim requires that every element of a claim is
`
`expressly or inherently disclosed in a single prior art reference.
`
`43.
`
`I understand that obviousness analysis involves comparing a claim to
`
`the prior art to determine whether the claimed invention would have been obvious
`
`to a person of ordinary skill in the art in view of the prior art and in light of the
`
`general knowledge in the art. I also understand when a person of ordinary skill in
`
`the art would have reached the claimed invention through routine experimentation,
`
`the invention may be deemed obvious.
`
`44.
`
`I also understand that obviousness can be established by combining or
`
`modifying the teachings of the prior art. Specific teachings, suggestions, or
`
`motivations to combine any first or primary prior art reference with a second prior
`
`art reference can be explicit or implicit, but must have existed before the ‘032
`
`patent was filed. I understand that the references themselves may be one source of
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` 18
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`Page 19 of 40
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`
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`a specific teaching or suggestion to combine features of the prior art, but that such
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`suggestions or motivations to combine art may come from other sources as well.
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`Specifically, the source may include logic, judgment, and common sense available
`
`to a person of ordinary skill rather than explicit statements in the prior art. I
`
`understand that it is not proper to combine references when there is a teaching
`
`away of such a combination. However, a reference’s mere disclosure of more than
`
`one alternative does not constitute teaching away from any of these alternatives.
`
`45.
`
`I further understand that whether there is a reasonable expectation of
`
`success from combining references in a particular way is also relevant to the
`
`analysis. I understand there may be a number of rationales that may support a
`
`conclusion of obviousness, including:
`
` Combining prior art elements according to known methods to yield
`
`predictable results;
`
` Substitution of one known element for another to obtain
`
`predictable results;
`
` Use of known technique to improve similar devices (methods, or
`
`products) in the same way;
`
` Applying a known technique to a known device (method, or
`
`product) ready for improvement to yield predictable results;
`
` “Obvious to try”—choosing from a finite number of identified,
`
`predictable solutions, with a reasonable expectation of success;
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` Known work in one field of endeavor may prompt variations of it
`
`for use in either the same field or a different one based on design
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`Page 20 of 40
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`incentives or other market forces if the variations are predictable to
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`one of ordinary skill in the art; or
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` Some teaching, suggestion, or motivation in the prior art that
`
`would have led one of ordinary skill to modify the prior art
`
`reference or to combine prior art teachings to arrive at the claimed
`
`invention.
`
`46.
`
`I understand that it is not proper to use hindsight in analyzing
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`combinations. My analysis of the prior art is determined at the time the invention
`
`was made.
`
`47.
`
`I understand that, for a reference to be used to show a claim is
`
`obvious, the reference can, as here, be analogous art to the claimed invention. See
`
`In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004); KSR Int’l Co. v. Teleflex Inc.,
`
`550 U.S. 398, 420 (2007). I understand that a reference is analogous to the claimed
`
`invention if the reference is from the same field of endeavor as the claimed
`
`invention, even if it addresses a different problem, or the reference is reasonably
`
`pertinent to the problem faced by the inventor, even if it is not in the same field of
`
`endeavor as the claimed invention. I understand that a reference is reasonably
`
`pertinent based on the problem faced by the inventor as reflected in the
`
`specification, either explicitly or implicitly.
`
`VII. Claim Terms
`
`48. Based on my review of the ‘032 patent, there are certain terms used in
`
`that patent that are used in the interventional cardiology device field and have
`
`particular meaning in that field. I applied such constructions where applicable, and
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`Page 21 of 40
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`in all other instances I used what I believe to be the broadest reasonable
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`construction of the claim terms, read in the context of the patent.
`
`1.
`
`“rail structure without a lumen”
`
`49.
`
`I agree with the statements made in the Petition that the term “rail
`
`structure without a lumen.” The word “rail” only appears in the specification of the
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`‘032 patent twice. The first reference appears in the Summary of the Invention
`
`regarding a “guidewire rail segment” which is defined as “permit[ing] delivery
`
`without blocking the use of the guide catheter.” (Id., 2:65-66). The other reference
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`to “rail” appears in the description of Fig. 17 as being “a plan view of a coaxial
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`guide catheter having a longer rail segment.” This description fails to offer any
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`further explanation as to which portion(s) of Figure 17 constitute the “rail
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`segment,” or what it is that the “rail segment” is “longer” than. Moreover, I agree
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`that under the broadest reasonable standard no support exists for the “rail without a
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`lumen” to be any particular structure. For example, the 032 specification does not
`
`specify that the rail portion should be the “tapered inner catheter,” “full
`
`circumference portion,” “cutout potion,” “reinforced portion,” “hemicylindrical
`
`portion,” “second full circumference portion”, “arcuate portion,” “braid or coil
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`reinforcement,” “most proximal portion of braid or coil reinforcement,” “relief
`
`cut,” “hemi-tube portion,” “single cuts,” “double cuts,” “connector hub,” “funnel
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`portion,” or “grip portion,” to name a few.
`
`50. Given this lack of clarity, a
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