IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE VOLCANO CORPORATION, Plaintiff, v. ST.

JUDE MEDICAL, CARDIOVASCULAR AND ABLATION TECHNOLOGIES DIVISION, INC.; ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.; ST. JUDE MEDICAL, U.S. DIVISION; ST. JUDE MEDICAL S.C., INC.; and ST. JUDE MEDICAL SYSTEMS AB, Defendants. C. A. No. JURY TRIAL DEMANDED

COMPLAINT FOR PATENT INFRINGEMENT Plaintiff Volcano Corporation brings this Complaint against defendants, St. Jude Medical, Cardiovascular and Ablation Technologies Division, Inc.; St. Jude Medical, Cardiovascular Division, Inc.; St. Jude Medical, U.S. Division; St. Jude Medical S.C.; and St. Jude Medical Systems AB (collectively, St. Jude), demands trial by jury, and alleges as follows: NATURE OF THE ACTION 1. This is a civil action arising out of St. Judes infringement of two United States

Patents in violation of the Patent Laws of the United States, 35 U.S.C. 271 and 281-285. PARTIES 2. Plaintiff Volcano Corporation is a Delaware corporation, and has its principal

place of business at 3661 Valley Centre Drive, Suite 200, San Diego, California 92130. Volcano manufactures, offers for sale and sells functional measurement guide wires, including the 1

Primewire Prestige Plus Pressure Guide Wire, Primewire Prestige Pressure Guide Wire, and Combowire XT Guide Wire. Volcanos guide wires are used for analyzing pressure and flow parameters from inside the blood vessels, including the blood vessels of the heart. Volcanos guide wires produce a simple, reproducible measurement, and are used in conjunction with angiography. The measurement obtained using Volcanos guide wires provides physicians with clinical guidance to aid appropriate treatment. Volcanos guide wires are used with Volcanos ComboMap Pressure and Flow System, SmartMap Pressure Instrument, s5 Imaging System and s5i Imaging System. 3. Defendant St. Jude Medical, Cardiovascular and Ablation Technologies Division,

Inc. (SJMCATD) has its principal place of business at 5050 Nathan Lane North, Plymouth, Minnesota 55442. SJMCATD resulted from the combination of St. Jude Medical Atrial Fibrillation Division, Inc. and St. Jude Medical, Cardiovascular Division, Inc., a Delaware corporation, in 2012. On information and belief, SJMCATD is a subsidiary of St. Jude Medical, Inc. 4. Defendant St. Jude Medical, Cardiology Division, Inc., (SJMCVD) is a

Delaware corporation, and has its principal place of business at 177 East County Road B, St. Paul, Minnesota 55117. On information and belief, SJMCVD is a subsidiary of St. Jude Medical, Inc. 5. Defendant St. Jude Medical, U.S. Division (SJMUSD) has its principal place of

business at 6300 Bee Cave Road, Building 2, Suite 100, Austin, Texas 78746. On information and belief, SJMUSD is a subsidiary of St. Jude Medical, Inc.

6.

Defendant St. Jude Medical S.C., Inc. (SJMSC) is a Minnesota corporation, and

has its principal place of business at 6300 Bee Cave Road, Building 2, Suite 100, Austin, Texas 78746. On information and belief, SJMSC is a subsidiary of St. Jude Medical, Inc. 7. Defendant St. Jude Medical Systems AB (SJMAB) is a Swedish corporation,

and has its principal place of business at Palmbladsgatan 10, SE-751 35, Uppsala, Sweden. In December 2008, St. Jude Medical Inc. bought Radi Medical Systems AB from Radi Medical AB. In November, 2009, the name of Radi Medical Systems AB was changed to SJMAB. On information and belief, SJMAB is a subsidiary of St. Jude Medical, Inc. JURISDICTION AND VENUE 8. This is a civil action arising under the Patent Laws of the United States, 35 U.S.C.

271 and 281-285. 9. This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.

1331 and 1338(a). 10. St. Jude makes, uses, offers for sale, sells and imports into the United States

cardiac pressure sensing guide wires, including the PressureWire Certus and PressureWire Aeris (the Accused Guide Wires). 11. In combination with the RadiAnalyzer Xpress Measurement System or

Ilumien PCI Optimization System, the PressureWire Certus is sold as the PressureWire Certus FFR Measurement System. 12. In combination with the RadiAnalyzer Xpress Measurement System, Ilumien

PCI Optimization System or the Quantien Integrated FFR Platform, the PressureWire Aeris is sold as the PressureWire Aeris FFR Measurement System.

13.

St. Jude makes, uses, offers for sale, sells and imports into the United States the

PressureWire Certus FFR Measurement System and the PressureWire Aeris FFR Measurement System (the Systems). 14. St. Jude Medical, Inc. advertises and promotes the Accused Guide Wires and the

Systems to medical professionals on its Internet website at www.sjmprofessional.com. 15. Sweden. 16. Thailand. 17. Rica. 18. SJMCATD. 19. SJMCVD. 20. SJMAB. 21. On information and belief, the Accused Guide Wires are imported into the United On information and belief, the Accused Guide Wires are manufactured by On information and belief, the Accused Guide Wires are manufactured by On information and belief, the Accused Guide Wires are manufactured by On information and belief, the Accused Guide Wires are manufactured in Costa On information and belief, the Accused Guide Wires are manufactured in On information and belief, the Accused Guide Wires are manufactured in

States by SJMCATD. 22. On information and belief, the Accused Guide Wires are imported into the United

States by SJMCVD. 23. On information and belief, the Accused Guide Wires are imported into the United

States by SJMSC.

24.

On information and belief, the Accused Guide Wires are offered for sale and sold

in the United States by SJMCATD. 25. On information and belief, the Accused Guide Wires are offered for sale and sold

in the United States by SJMUSD. 26. On information and belief, the Accused Guide Wires are offered for sale and sold

in the United States by SJMCVD. 27. On information and belief, the Accused Guide Wires are offered for sale and sold

in the United States by SJMSC. 28. 29. 30. 31. 32. SJMSC. 33. On information and belief, the Systems are offered for sale and sold in the United On information and belief, the Systems are manufactured in Sweden. On information and belief, the Systems are manufactured in Thailand. On information and belief, the Systems are manufactured in Costa Rica. On information and belief, the Systems are manufactured by SJMAB. On information and belief, the Systems are imported into the United States by

States by SJMUSD. 34. On information and belief, the Systems are offered for sale and sold in the United

States by SJMSC. 35. On information and belief, the Court has personal jurisdiction over SJMCATD

and SJMCVD because each is a corporation incorporated in the State of Delaware. 36. The Court has personal jurisdiction over SJMCATD, SJMCVD, SJMUSD, and

SJMSC because each conducts business in this judicial district and because each has participated in infringing activities within this judicial district.

37.

Venue is proper in this judicial district pursuant to 28 U.S.C. 1391. VOLCANOS PATENTED INVENTIONS

38.

Dr. Douglas Corl, Robert Obara and John Ortiz, researchers at Volcanos

predecessor, Cardiometrics, Inc. (Cardiometrics), were the first to invent a pressure sensing guide wire that uses a solid state pressure sensor. 39. Cardiometrics solid state pressure sensing guide wire invention has an

approximately uniform diameter from its proximal portion to its distal portion. Previous pressure sensing probes included a permanently affixed large opto-electronic component at their proximal end. Unlike those probes, Cardiometrics solid state pressure sensing guide wire could be used with over-the-guide wire catheters in the same manner as those catheters were used with traditional or main-line cardiac guide wires. 40. To isolate the solid state pressure sensor from mechanical forces and to enable

their solid state pressure sensing guide wire to be inserted into very narrow cardiac vessels, the Cardiometrics inventors provided their guide wire with a sensor housing surrounded both proximally and distally with flexible regions. This design provided their guide wire invention with a flexible floppy tip portion. 41. Cardiometrics sold its inventive solid state pressure sensing guide wire as the

WaveWire. Cardiometrics sold its display analyzer, known as the WaveMap, for use with the WaveWire. Cardiometrics demonstrated its WaveWire and WaveMap at the Rotterdam Stent Course on December 11, 1996. On information and belief, 1,200 cardiologists from around the world attended this conference. The demonstration of the WaveWire System was performed on a live human patient. The demonstration was viewed via video transmission by

attendees of the Rotterdam Stent Course. Since at least 1996, employees of and consultants to Radi Medical AB and SJMAB have known of Cardiometrics WaveWire. FIRST CLAIM FOR RELIEF Infringement of United States Patent No. 8,419,648 42. here in full. 43. United States Patent No. 8,419,648 (the 648 Patent), a copy of which is Volcano incorporates by reference the allegation of paragraphs 1-41 as if repeated

attached as Exhibit A to this complaint, is entitled Ultra Miniature Pressure Sensor and issued on April 16, 2013. Volcano is the owner by assignment of the 648 Patent. 44. 45. 46. 47. The Accused Guide Wires practice at least one of the claims of the 648 Patent. St. Jude directly infringes at least one of the claims of the 648 Patent. Each Accused Guide Wire is a pressure sensor apparatus. The Accused Guide Wires include a long proximal hypotube having an outside

diameter of less than 0.018 inches. 48. The Accused Guide Wires include a first flexible element disposed distal of the

long proximal hypotube. a. b. c. The first flexible element has a length of approximately 27 centimeters. The first flexible element is formed of a plastic material. The first flexible element has an increased flexibility relative to the long proximal hypotube. 49. The Accused Guide Wires include a short hypotube sensor housing disposed

distal of the distal extremity of the first flexible element.

a.

The short hypotube sensor housing has a cylindrical wall with an outer diameter of less than 0.018 inches and a length between 1 millimeter and 5 millimeters.

b. 50.

The short hypotube sensor housing has a cutout in the cylindrical wall.

The Accused Guide Wires include a second flexible element disposed distally

from the short hypotube sensor housing. 51. The second flexible element has an outer diameter of less than 0.018 inches. a. The second flexible element has an increased flexibility relative to the long proximal hypotube. b. The second flexible element comprises a radiopaque material.

52.

c. The second flexible element has a length of approximately 3 centimeters. The Accused Guide Wires include an end cap disposed distally of the second

flexible element. a. 53. The Accused Guide Wires include a rounded end cap.

The Accused Guide Wires include a core wire extending from a proximal

extremity of the long proximal hypotube, through the sensor housing, and to a distal extremity of the second flexible element. a. The core wire tapers from a larger diameter to a smaller diameter as the core wire extends distally within the first flexible element. 54. The Accused Guide Wires include a solid state pressure sensor. a. The solid state pressure sensor is mounted within the short hypotube sensor housing.

b.

The solid state pressure sensor is secured within the short hypotube sensor housing by an adhesive.

c.

The solid state pressure sensor is mounted such that a pressure sensitive region of the solid state pressure sensor is exposed to ambient via the cutout.

d.

The pressure sensitive region of the solid state pressure sensor includes a diaphragm structure.

e.

The pressure sensitive region of the solid state pressure sensor includes a base plate.

f.

The solid state pressure sensor includes at least one resistive element responsive to changes in pressure.

55.

The Accused Guide Wires include electrical conductors extending from a

proximal extremity of the long proximal hypotube to the solid state pressure sensor. a. The electrical conductors are coupled to the solid state pressure sensor within the short hypotube sensor housing. b. The electrical conductors are coupled to conducting sleeves at the proximal extremity of the long proximal hypotube. 56. St. Judes infringement of the 648 Patent is and continues to be without

permission, consent, authorization, or license from Volcano. 57. 58. St. Judes infringement of the 648 Patent is causing Volcano substantial damage. St. Judes infringement has injured Volcano. As a result, Volcano is entitled to

recover damages adequate to compensate for such infringement, including a recovery of lost

profits and in no event less than a reasonable royalty for St. Judes improper use of Volcanos invention. 59. deliberate. 60. The 648 Patent issued from patent application serial number 11/303,249. On St. Judes infringement of the 648 Patent is and continues to be willful and

information and belief, St. Jude monitors the prosecution of Volcanos pending patent applications. On information and belief, St. Jude knew prior to the issuance of the 648 Patent that the claims of the 648 Patent were allowed by the USPTO. The claims of the 648 Patent were allowed by the USPTO on March 5, 2013. On information and belief, and despite knowing that the allowed claims of the 648 Patent would issue to Volcano in due course, St. Jude continued to make, use, offer for sale, sell and import into the United States the Accused Guide Wires. 61. St. Jude continues to willfully infringe the 648 Patent knowing its Accused

Guide Wires directly infringe Volcanos patent rights and has done so since the day the 648 Patent issued. St. Jude has acted in an objectively reckless fashion by continuing to make, use, sell, offer for sale, and import the Accused Products with knowledge of the claims of the 648 Patent. SECOND CLAIM FOR RELIEF Infringement of United States Patent No. 8,419,647 62. Volcano incorporates by reference the allegations of paragraphs 1-61 as if

repeated here in full. 63. United States Patent No. 8,419,647 (the 647 Patent), a copy of which is

attached as Exhibit B to this complaint, is entitled Ultra Miniature Pressure Sensor and issued on April 16, 2013. Volcano is the owner by assignment of the 647 Patent.

10

64.

The Accused Guide Wires and at least one System are used to practice at least one

claim of the 647 Patent. 65. a patient. 66. The pressure sensor assembly of the Accused Guide Wires is used to obtain a The Accused Guide Wires and at least one System are used to evaluate a vessel of

pressure measurement from within the vessel. 67. The pressure sensor assembly of the Accused Guide Wires is used to obtain a

pressure measurement from within the vessel distal of a stenosis. 68. The pressure sensor assembly of the Accused Guide Wires is used to perform an

angioplasty procedure where an angioplasty catheter is advanced over the Accused Guide Wire. 69. The pressure sensor assembly of the Accused Guide Wires is used to perform an

angioplasty procedure that includes inflating a balloon of an angioplasty catheter to dilate the stenosis of the vessel. 70. The Accused Guide Wires include a long tubular member having an outer

diameter of less than 0.018 inches. a. The long tubular member has a proximal portion and an opposing distal portion. 71. The Accused Guide Wires include a core wire that extends within the long tubular

member from the proximal portion to the distal portion. a. b. The core wire has a tapered distal section. The core wire has a tapered distal section that tapers from a larger diameter to a smaller diameter as the core wire extends distally.

11

72.

The Accused Guide Wires include a flexible element coupled to the distal portion

of the elongate tubular member a. b. The flexible element has an outer diameter of less than 0.018 inches. The flexible element has an increased flexibility compared to the long tubular member. c. 73. element. a. b. The sensor housing has an outer diameter of less than 0.018 inches. The sensor housing has a length of between 1 millimeter and 5 millimeters. c. d. The sensor housing has an external wall. The sensor housing has an external wall thickness of between 0.001 inches and 0.002 inches. e. f. The sensor housing has a lumen. The sensor housing has an opening extending through a portion of the external wall to the lumen. 74. The Accused Guide Wires include a pressure sensor assembly. a. b. The pressure sensor assembly is disposed within the sensor housing. The pressure sensor assembly is in fluid communication with the opening of the sensor housing. c. The pressure sensor assembly is secured to the sensor housing by an adhesive. The flexible element has a length of approximately 27 centimeters.

The Accused Guide Wires include a sensor housing coupled to the flexible

12

75.

The Accused Guide Wires include three electrical conductors electrically coupled

to the pressure sensor assembly. 76. The Accused Guide Wires include three electrical conductors extending from the

pressure sensor assembly to the proximal portion of the long tubular member. 77. The Accused Guide Wires include a flexible structure coupled to and extending

distally from the sensor housing. a. b. c. 78. The flexible structure is made of a radiopaque material. The flexible structure has an outer diameter of less than 0.018 inches. The flexible structure has a length of approximately 3 centimeters.

St. Jude is inducing and continues to induce direct infringement of the 647 Patent

in violation of 35 U.S.C. 271(b). St. Jude is taking and continues to actively take steps to facilitate the purchase and distribution of the Accused Guide Wires and Systems with knowledge that their use infringes one or more claims of the 647 Patent. St. Judes sale of the Accused Guide Wires and Systems is done with the specific intent to induce direct infringement by the users of the Accused Guide Wires and Systems. 79. St. Jude is and continues to promote, teach, instruct, and train cardiologists to use

the Accused Guide Wires and Systems. St. Jude provides instructions for use of the Accused Guide Wires and Systems to cardiologists through its Internet website, in writing and through training courses. 80. Following St. Judes instructions, cardiologists use and continue to use the

Accused Guide Wires and Systems in diagnostic cardiac procedures. The use of the Accused Guide Wires and Systems by cardiologists constitutes direct infringement of at least one claim of the 647 Patent.

13

81.

On information and belief, St. Jude is and continues to act with specific intent to

induce direct infringement of the 647 Patent by importing, offering for sale, selling and supporting and instructing cardiologists to use the Accused Guide Wires with the Systems with knowledge of the 647 Patent. 82. St. Jude is and continues to contribute to the infringement of the 647 Patent in

violation of 35 U.S.C. 271(c) by offering for sale, selling, importing into the United States, promoting, teaching, and encouraging the use of the Accused Guide Wires and Systems. St. Jude markets the Accused Guide Wires as especially made or especially adapted for use in measuring pressure inside the vessels. The Accused Guide Wires are not staple articles of commerce suitable for substantial non-infringing use. The Accused Guide Wires are cleared by the FDA only for the intended use of providing pressure signals from the coronary and peripheral vessels and to guide the positioning of interventional devices. 83. St. Judes infringement of the 647 Patent has been without permission, consent,

authorization, or license from Volcano. 84. St. Judes infringement of the 647 Patent is and continues to cause Volcano

substantial damage. 85. St. Judes infringement has injured Volcano. As a result, Volcano is entitled to

recover damages adequate to compensate for such infringement, including a recovery of lost profits and no event less than a reasonable royalty for St. Judes improper use of Volcanos invention. 86. deliberate. St. Judes infringement of the 647 Patent is and continues to be willful and

14

87.

The 647 Patent issued from patent application serial number 13/169,174. On

information and belief, St. Jude has monitored and continues to monitor the prosecution of Volcanos pending patent applications. On information and belief, St. Jude knew prior to the issuance of the 647 Patent that the claims of the 647 Patent were allowed by the USPTO. The USPTO allowed the claims of the 647 Patent on March 5, 2013. On information and belief, and despite knowing that the allowed claims of the 647 Patent would issue to Volcano in due course, St. Jude continued to make, use, offer for sale, sell and import into the United States the Accused Guide Wires and Systems. 88. St. Judes willful acts of infringement are and continue to be committed with

knowledge that the use of the Accused Guide Wires and Systems by its customers constitute direct infringement of Volcanos patent rights beginning on the day the 647 Patent issued. St. Jude has acted in an objectively reckless fashion by continuing to make, use, sell, offer for sale, and import the Accused Products and Systems with knowledge of the claims of the 647 Patent. PRAYER FOR RELIEF WHEREFORE, Volcano respectfully requests this Court enter judgment and provide the following relief: A. B. C. That St. Jude has infringed the 648 Patent; That St. Jude has infringed the 647 Patent; That St. Jude and its officers, agents, servants, employees, attorneys, and those

persons in active concert or participation with them who receive actual notice of the Order, be enjoined from committing further acts of infringement of the 648 Patent, including by inducing or contributing to that infringement;

15

D.

That St. Jude and its officers, agents, servants, employees, attorneys, and those

persons in active concert or participation with them who receive actual notice of the Order, be enjoined from committing further acts of infringement of the647 Patent, including by inducing or contributing to that infringement; E. That St. Jude pay to Volcano the damages resulting from its infringement of the

648 Patent in an amount equivalent to Volcanos lost profits, and no less than a reasonable royalty; F. That St. Jude pay to Volcano the damages resulting from its infringement of the

647 Patent in an amount equivalent to Volcanos lost profits, and no less than a reasonable royalty; G. That St. Jude be ordered to account for additional damages for any and all periods

of infringement not included in the damages awarded by the Court or jury, including specifically any time periods between any order or verdict awarding damages and entry of final judgment; H. I. J. K. Patent; L. Patent; M. That this case be found exceptional within the meaning of 35 U.S.C. 285, and That St. Jude be declared a willful infringer of one or more claims of the 647 That Volcano be awarded increased damages under 28 U.S.C. 284; That Volcano be awarded prejudgment interest from the date infringement began; That Volcano be awarded post judgment interest; That St. Jude be declared a willful infringer of one or more claims of the 648

Volcano awarded its reasonable attorney fees and expenses; N. That Volcano be awarded its costs of suit; and

16

O. to Volcano.

That such other and further relief as this Court deems proper and just be awarded

JURY DEMAND Pursuant to Fed. R. Civ. P. 38(b), Volcano demands a trial by a jury on all issues properly tried to a jury. Dated: April 16, 2013 FISH & RICHARDSON P.C. By: /s/ Thomas L. Halkowski Thomas L. Halkowski (No. 4099) A. Martina Tyreus Hufnal (No. 4771) 222 Delaware Avenue, 17th Floor P. O. Box 1114 Wilmington, DE 19899-1114 Emails: halkowski@fr.com; hufnal@fr.com Telephone: (302) 652-5070 Frank E. Scherkenbach, pro hac vice One Marina Park Drive Boston, MA 02210-1878 Email: scherkenbach@fr.com Telephone: (617) 542-5070 Todd G. Miller, pro hac vice Michael M. Rosen, pro hac vice 12390 El Camino Real San Diego, CA 92130 Emails: miller@fr.com; rosen@fr.com Telephone: (858) 678-5070 Corrin N. Drakulich, pro hac vice Christina Brown-Marshall, pro hac vice 500 Arguello Street, Suite 500 Redwood City, CA 94063 Email: drakulich@fr.com; brown-marshall@fr.com Telephone: (650) 839-5070 Facsimile: (650) 839-5071 ATTORNEYS FOR PLAINTIFF
VOLCANO CORPORATION

17