IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`In the Inter Partes Review of:
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`
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`U.S. Patent No. 6,482,228
`
`Filed: November 14, 2000
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`
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`
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`Trial Number: To Be Assigned
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`Issued: March 25, 2003
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`
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` Attorney Docket No.: 058888-0000014
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`Inventor(s): Norred, Troy R.
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`Assignee: Norred, Troy R.
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`
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`Panel: To Be Assigned
`
`Title: PERCUTANEOUS AORTIC VALVE
`REPLACEMENT
`__________________________________________________________________
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
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`DECLARATION OF THOMAS VASSILIADES, JR., M.D.
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`I, Thomas Vassiliades, Jr., M.D., declare as follows:
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`1.
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`I am over 18 years of age. I make this declaration based on my own
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`personal knowledge, personal experience, and belief. If called upon, I can
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`competently testify to the facts stated in this declaration.
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`2.
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`I am currently the Vice President of Medical Affairs for the Structural
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`Heart Division of Medtronic, Inc. A copy of my curriculum vitae is attached as
`
`Exhibit 1.
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`Page | 1
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1013 - Page 1
`
`
`
`
`In the Inter Partes Review of:
`
`
`
`U.S. Patent No. 6,482,228
`
`Filed: November 14, 2000
`
`
`
`
`
`Trial Number: To Be Assigned
`
`Issued: March 25, 2003
`
`
`
` Attorney Docket No.: 058888-0000014
`
`Inventor(s): Norred, Troy R.
`
`Assignee: Norred, Troy R.
`
`
`
`Panel: To Be Assigned
`
`Title: PERCUTANEOUS AORTIC VALVE
`REPLACEMENT
`__________________________________________________________________
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`DECLARATION OF THOMAS VASSILIADES, JR., M.D.
`
`
`I, Thomas Vassiliades, Jr., M.D., declare as follows:
`
`1.
`
`I am over 18 years of age. I make this declaration based on my own
`
`personal knowledge, personal experience, and belief. If called upon, I can
`
`competently testify to the facts stated in this declaration.
`
`2.
`
`I am currently the Vice President of Medical Affairs for the Structural
`
`Heart Division of Medtronic, Inc. A copy of my curriculum vitae is attached as
`
`Exhibit 1.
`
`
`
`Page | 1
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1013 - Page 1
`
`
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`3.
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`I earned a Bachelor of Arts degree (AB) from Duke University in
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`Durham, North Carolina. I earned a Doctor of Medicine degree (MD) from the
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`University of North Carolina School of Medicine at Chapel Hill, North Carolina.
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`Lastly, I earned a Master of Business Administration degree (MBA) from Emory
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`University’s Goizueta Business School in Atlanta, Georgia.
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`4.
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`I completed my general surgery residency at Emory University
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`Affiliate Hospitals in Atlanta, Georgia. Additionally, I completed my fellowship
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`training in cardiothoracic surgery at the University of Michigan Hospitals in Ann
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`Arbor, Michigan.
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`5.
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`From 1992 to 2003 I worked as a cardiac surgeon, first at Holmes
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`Regional Medical Center in Melbourne, Florida and then at Cardiothoracic
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`Surgical Associates of Northwest Florida in Pensacola, Florida.
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`6.
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`From 1993 to 2003 I also worked as the Founder/Director of Cardiac
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`Surgery at Cardiology Consultants in Pensacola, Florida; the Founder/Director of
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`Cardiac Surgery at Baptist Hospital in Pensacola, Florida; and the Director of
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`Cardiothoracic Surgery at Sacred Heart Hospital in Pensacola, Florida.
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`7.
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`From 2003 to 2005, I served as an Assistant Professor in the
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`Department of Surgery, Division of Cardiothoracic Surgery, at Emory University’s
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`School of Medicine. From 2005 to 2010, I served as an Associate Professor in the
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`Department of Surgery, Division of Cardiothoracic Surgery, at Emory University’s
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`Page | 2
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1013 - Page 2
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`School of Medicine.
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`8.
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`I have extensive experience in treating heart valve disease. During my
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`clinical practice career, I performed and participated in approximately 5,000 heart
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`procedures of which approximately 1,000 of these were heart valve operations,
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`consisting of valve repair and replacement of all four heart valves.
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`9.
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`I am a member of the American Board of Surgery and the American
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`Board of Thoracic Surgery.
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`10. From 1995 to 2001 I served as the Executive Councilor of the Florida
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`Society of Thoracic and Cardiovascular Surgeons.
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`11.
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`In 2003 I joined the American Society for Thoracic Surgery and the
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`Society of Thoracic Surgeons (“AATS/STS”) joint Work Force on the Evaluation
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`of New Technology. From 2004 to 2005 I served as the Co-Chair of the
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`AATS/STS Joint Task Force on Percutaneous Valve Technology. In 2008 I joined
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`the AATS/STS Tech-Con Workforce, which focuses on novel therapies in cardiac
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`and general thoracic surgery. In 2009 I joined the Society of Thoracic Surgeons’
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`Program Committee and began serving as the Tech-Con Co-Director.
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`12. From 2005-2007 I was a member of the Heart Valve Society of
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`America’s Therapeutic Interventions Council.
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`13.
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`In 2005 I was appointed to the Circulatory Devices Panel of the
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`Medical Devices Advisory Committee of the Center for Device and Radiological
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`Page | 3
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1013 - Page 3
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`
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`Health of the Food and Drug Administration in Washington, DC.
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`14.
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`In 2007 I joined the Executive Committee and Board of Directors for
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`the International Society for Minimally Invasive Cardiothoracic Surgery.
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`15. My research includes heart valves and replacement heart valves,
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`including serving as an investigator on the following: “The Partner Trial:
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`Placement of Aortic Transcatheter Valves: Edwards SAPIEN Transcatheter Heart
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`Valve” (co-investigator); “Development of a Set of Devices and Techniques for the
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`Minimally Invasive Treatment of Aortic Stenosis” (co-principle investigator); and
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`“EVEREST Percutaneous Mitral Valve Repair” (local principle investigator).
`
`16.
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`I have participated in lectures, seminars, and visiting professorships
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`concerning heart valves and replacement heart valves, including speaking on
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`“Percutaneous Heart Valve Technology” at the 21st Annual Cardiovascular
`
`Conference in Hawaii on February 16, 2008 in Kona, Hawaii and “Valve
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`Replacement” at the American Heart Association, Local Chapter Meeting on
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`January 26, 1994 in Pensacola, Florida.
`
`17.
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`I have authored articles and book chapters on heart valve and
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`replacement heart valves,
`
`including:
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`“Percutaneous Pulmonary Valve
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`Replacement: 3-Month Evaluation of Self-Expanding Valved Stents” (Invited
`
`Commentary, Ann Thorac Surg 2006; 82:708-713); “The Clinical Development of
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`Percutaneous Heart Valve Technology: a Position Statement of the Society of
`
`
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`Page | 4
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1013 - Page 4
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`
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`Thoracic Surgeons (STS), the American Association for Thoracic Surgery
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`(AATS), and the Society of Cardiovascular Angiography and Intervention (SCAI)”
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`(J. Thoracic Cardiovascular Surgery 2005; 129(5):970-6; J. Am. Coll. Cardiol.
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`2005; 45(9):1554-60; Ann. Thorac. Surg. 2005; 79(5):1812-8; and Catheter
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`Cardiovasc.
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`Interv. 2005; 65(1):73-79); “Fixing broken heart valves
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`percutaneously: the shape of things to come?” (Expert Review of Cardiovascular
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`Therapy 2006; 4(1):1-3); “Percutaneous Heart Valve Technology: As I See It.”
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`(Cardiothoracic Surgery Network, October, 2005); and “Percutaneous valve
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`technologies for aortic valve replacement” (Advances and Controversies in Adult
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`Heart Valve Surgery, Termedia, 2007).
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`18. This declaration is submitted in support of the petition for inter partes
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`review to be filed by Medtronic, Inc. in respect to U.S. Patent No. 6,482,228 to
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`Norred, issued November 19, 2002 and titled “Percutaneous aortic valve
`
`replacement.” (“the ‘228 Patent”).
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`19.
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`In preparing this statement, I studied the ‘228 Patent and six
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`references, namely: a German article titled “A Foldable, Artificial Heart Valve,”
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`published by Spiegel Online (“Spiegel”); German Patent Application No. 195 46
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`692 (“Figulla”); German Patent Application No. 198 57 887 A1 (“Fraunhofer”);
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`U.S. Patent No. 6,454,799 (“Schreck”); U.S. Patent No. 6,425,916 (“Garrison”);
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`and U.S. Patent No. 3,657,744 (“Ersek”) (collectively, the “Prior Art References”).
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`Page | 5
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1013 - Page 5
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`
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`I understand that the Prior Art References form the basis for the grounds of
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`rejections set forth in the Petition for Inter Partes Review of the ‘228 Patent.
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`20.
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`I have been asked to provide my insight on the operation of prosthetic
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`heart valves and specifically the heart valves disclosed in the Prior Art References
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`that form the basis for the grounds of rejections set forth in the Petition for Inter
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`Partes Review of the ‘228 Patent.
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`21. During each cardiac cycle, the natural heart valves alternatively open
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`to allow blood to flow through them and then close to block blood flow. During
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`systole, the aortic and pulmonary valves open to allow blood flow into the aorta
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`and pulmonary arteries. Conversely, during diastole, the aortic and pulmonary
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`valves close to prevent reverse blood flow from the aorta and pulmonary arteries
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`into the ventricle.
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`22. Natural heart valves open and close passively in response to blood
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`pressure changes operating against the valves’ leaflet structure. Specifically, the
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`valve leaflets open when the forward pressure gradient urges blood flow forward
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`and close when the forward pressure gradient reverses and urges blood flow
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`backward.
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`23. A prosthetic heart valve must necessarily function in the same manner
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`as the natural heart valve it replaces. Thus, passive prosthetic valves, both of
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`mechanical and tissue design (including prosthetic tissue heart valves that
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`Page | 6
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1013 - Page 6
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`
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`incorporate pig heart valves), utilize the pressure gradient created during systole
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`and diastole to open and close the prosthetic valve such that the blood flow
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`controlling function of the natural valve is replaced.
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`24. The Prior Art References disclose prosthetic heart valves that replace
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`the function of natural heart valves in controlling the flow of blood. Therefore, it is
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`readily apparent that the prosthetic heart valves of the Prior Art References must
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`necessarily control the flow of blood by moving between open and closed positions
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`in response to pressure differential changes caused by the heart during diastole and
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`systole.
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`25.
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`In order to control the flow of blood, it is necessary that the leaflets of
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`the prosthetic valves disclosed in the Prior Art References must necessarily move
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`between a closed position and an open position in response to pressure changes in
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`the aorta.
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`26. Specifically, in order to control the flow of blood, it is necessary that
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`the leaflets of the prosthetic valves disclosed in the Prior Art References move to
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`an open position in response to systolic ejection of blood from the left ventricle.
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`27. Specifically, in order to control the flow of blood, it is necessary that
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`the leaflets of the prosthetic valves disclosed in the Prior Art References move to a
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`closed position in response to diastolic filling of the left ventricle.
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`Page | 7
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1013 - Page 7
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`28. One of ordinary skill in the art would understand the above described
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`functionality to necessarily exist in each of the prosthetic heart valves of the Prior
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`Art References.
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`I declare under penalty of perjury under the laws of the United States of
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`America that the foregoing is true and correct.
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`Executed this L%ay of October, 2013 in Minneapolis, Minnesota, United
`States.
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`Thomas Vassiliades! Jr., M.D.
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`Page I B
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1013 - Page 8
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