September 16, 2016

Substantial Evidence Supported Infringement of Limitations That Did Not Need Construction

By Bryan K. Wheelock, Principal

In Lifenet Health v. Lifecell Corporation, [2015-1549](September 16, 2016) the Federal Circuit affirmed the district court’s judgment that the claims of U.S. Patent No. 6,569,200 on plasticized soft tissue grafts suitable for transplantation into humans were not invalid and were infringed.

At issue was the claim language that the “one or more plasticizers are not removed
from said internal matrix of said plasticized soft tissue graft prior to transplantation into a human.”  This language was added during prosecution to distinguish over prior art where the introduced plasticizers were removed before implantation.  The accused product instructed users to soak the grafts in saline which would remove as much as 50% of the plasticizers.

The district court found that no further claim construction was needed.  Lifecell argued that the district court failed to resolve a legal dispute regarding the scope of the claim, however the Federal Circuit found that Lifecell did not properly raise the issue.  Lifecell wanted the jury to be instructed that removal of any plasticizer from any part of the graft was enough to avoid infringement, which the Federal Circuit found was not only an argument about degree of removal, but also an argument about from where the plasticizer is not to be removed.  Regarding degree, Lifecell did get the interpretation  and instruction it wanted.  Regarding location, Lifecell failed to properly raise an issue of what “internal matrix” meant.

Examining the record, the Federal Circuit found that there was substantial evidence to support the jury’s determination that plasticizer is not removed “from the internal matrix” of the accused tissue grafts before transplantation.

The Federal Circuit went on to reject Lifecell’s arguments based on joint infringement, finding that the limitations were not steps that needed to be performed, but limitations on the structure.  Similarly, the Federal Circuit rejected the argument that the claim contained mixed method and apparatus limitations.