The U.S. Court of Appeals for the Federal Circuit affirmed a district court’s summary judgment that Align Technology did not infringe Ormco’s patents protecting custom orthodontic appliances marketed as Invisalign®, deciding that certain claims of the patents were invalid for lack of enablement. Ormco Corp. v. Align Tech., Inc., Case Nos. 06-1240, -1274 (Fed. Cir., Aug. 24, 2007) (Lourie, J.; O’Malley, J. dissenting).
Ormco asserted four patents directed to the computer-aided design and manufacture of custom orthodontic appliances against Align, which counterclaimed by asserting two of its own patents. The trial court not only granted Align’s motion for summary judgment of non-infringement, but also granted Align’s motion for summary judgment of non-enablement three months later. In construing the claims, the district court limited the claims of the Ormco patents to a process in which final treatment positions for teeth are automatically determined. The court then determined that there were no genuine issues of material fact precluding summary judgment.
On appeal, the Federal Circuit found clear and convincing evidence that a person of ordinary skill in the art did not and could not accomplish automatic computer determination of teeth finish positions based upon the Ormco patents’ specification. The Court pointed to inventor testimony that a manual override had been used on all of the approximately forty cases treated using Ormco’s Insignia product and that, while it was a goal to have the Insignia software generate final tooth positions that would not require use of the override, variations in human anatomy had prevented the attainment of that goal. The Ormco inventor had further testified that he was unsure if the problems due to variations in human anatomy could be overcome. The Court concluded that an inventor’s failure to enable his invention in a commercial product that purports to be an embodiment of the patented invention is strong evidence that the patent specification lacks enablement. Thus, relying on the fact that considerable doubt existed with respect to sufficiently enabling disclosure, the Federal Circuit affirmed the trial court’s finding of summary judgment of non-enablement.
In dissent, Judge O’Malley, sitting by designation, disapproved of the majority’s importation of a limitation into the claims by requiring the automatic determination of tooth positions and further criticized the majority and the trial court for failing to address any of the Wands factors.
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