Saffran v. Johnson & Johnson, No. 2010-1426, 712 F.3d 549 (Fed. Cir. Apr. 4, 2013)

Saffron’s U.S. Patent No. 5,653,760 claims a device for treating an injury (such as a fractured bone) by deploying a cellular or molecular treatment layer at the injury site to encourage regeneration of tissue. Saffron sued Cordis, alleging that its medicated Cypher stents infringe the patent. The parties disputed construction of the term “device,” and the E.D. Texas district court held that it was non-limiting preamble language (even though it also appeared in some claims’ bodies). At trial, the jury returned a verdict for Saffron, finding the patent infringed and valid. After adding pre-judgment interest, the Court awarded Saffron damages just under $600 million.

On appeal, Cordis argued that a critical feature of the ‘760 patent was a “device” deploying treatment as a sheet (i.e., layer) at the injury site. Cordis focused on Saffran’s overcoming prior art rejections during prosecution by representing to the examiner that “[t]he device used is a sheet rather than a pre formed chamber.” Mindful its prior holdings that “prosecution disclaimer requires clear and unambiguous disavowal of claim scope” the Federal Circuit nevertheless acknowledged that “applicants rarely submit affirmative disclaimers along the lines of ‘I hereby disclaim the following . . .’ during prosecution and need not do so to meet the applicable standard.” The Court therefore construed “device” as limited to deployment of a sheet, and directed judgment of non-infringement for Cordis because stents are mesh structures and the medicated “layer is akin to paint on a chain link fence, not a continuous sheet wrapped around the mesh.”

The Court also reversed the district court’s ruling on the corresponding structure for a 112 ¶ 6 claim term, holding the structure specifically requires a “hydrolyzable bond” between treatment materials and a device sheet. Because Cordis stents did not use a hydrolyzable bond, the Court directed judgment of non-infringement on these grounds as well.