Certain Balloon Dilation Devices, Systems, and Components Thereof; Inv. No. 337-TA-1449 (Violation)

ALJ Hines found a violation of section 337 as to all three asserted patents (the 878, 472 and 847 patents). She found asserted claims 1, 14, 20, 22 and 23 of the 878 patent, claim 1 of the 472 patent and claims 1 and 11 of the 847 patent infringed. Fiagon did not prove the claims indefinite, and the domestic industry requirement was met. The ALJ recommends a limited exclusion order against Fiagon's VenSure devices and components, with a certification provision for the Cube Navigation System outside sinus dilation. She also recommends a cease and desist order with carve-outs and a 61 percent bond for the VenSure products and none for the Cube. The Commission will decide whether to review the determination and may modify the recommended remedy. Importation was satisfied by post-issuance imports of components (Y-connector, handle shells, indeflator parts, bending tool, Light Guide, Sensor Carrier, Cube) that are articles that infringe, directly or by induced and contributory infringement. Fiagon failed to prove by clear and convincing evidence that the 847 patent terms 'rigidity' and 'about' (inner diameter and wall thickness ranges) are indefinite. The ALJ also rejected the argument that the 878 patent ports must be integral with the handle. Fiagon's claimed good faith belief of non-infringement was rejected as unreasonable because it rested on movable-shaft theories not found in the claims. The knowledge and intent requirements for indirect infringement were therefore met. The VenSure products infringe the asserted claims, including claim 11 of the 847 patent, and the technical prong was found satisfied for all three patents. The economic prong was found satisfied through significant U.S. plant and equipment and labor or capital investments. The ALJ recommends a limited exclusion order with Cube certification, a cease and desist order against Fiagon because of its component inventory, and a 61 percent bond for VenSure products with no bond for the Cube.