How the Printed Matter Doctrine Sees Through X-Ray Markers
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How the Printed Matter Doctrine Sees Through X-Ray Markers
"The Federal Circuit's first decision in the long-running C.R. Bard v. AngioDynamics litigation had held that the informational content conveyed by radiographic markers on vascular access ports constitutes printed matter not entitled to patentable weight, but that the structural requirement of a radiographically discernible marker could still distinguish the claims from prior art. C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372 (Fed. Cir. 2020)."
"The patents at issue claim assemblies and methods for identifying "power injectable" vascular access ports. These are devices implanted beneath a patient's skin that allow medical providers to inject fluids directly into the veins. Power injection involves high-pressure, high-flow-rate delivery of contrast agents during CT imaging. Following a 2005 FDA warning about port failures during power injection, Bard developed ports with radiographic markers (the letters "CT" etched in titanium foil) that would appear on x-ray scout scans, allowing clinicians to confirm the port was rated for power injection before use."
Federal Circuit affirmed anticipation-based invalidity of patent claims covering vascular access ports marked with radiographic "CT" indicators. The radiographic letters were treated as printed matter, which carries no patentable weight for the informational content. Only the structural requirement of a radiographically discernible marker could serve to distinguish claims from prior art. After retrial and post-trial judgment, the appeals court concluded that once the informational content is stripped away, the remaining claimed structural features were anticipated. The ports were created to help clinicians confirm suitability for high-pressure CT contrast injection following a 2005 FDA warning.
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