Unsuccessful Commercial Embodiment Evidences Lack of Enablement

In Ormco Corporation, et al. v. Align Technology, Inc. (August 24, 2007), one of the inventors of the Ormco patents, testified that Ormco had never attempted to create a computerized system that automatically determined tooth positions without human decision making. He also testified that the manual override had been used on all of the approximately forty cases treated using the Insignia product and that, while it was a goal to have the software generate final tooth positions that would not require use of the override, variations in human anatomy had prevented the attainment of that goal. Dr. Andreiko was also unsure if the problems due to variations in human anatomy could be overcome.

According to the opinion by Circuit Judge Lourie:

"If an inventor attempts but fails to enable his invention in a commercial product that purports to be an embodiment of the patented invention, that is strong evidence that the patent specification lacks enablement. Substantial doubt concerning the enablement of the invention was cast by the inventors in this case. The district court so concluded, and we have no reason to disagree. We thus affirm the summary judgment of nonenablement as to claims 1, 9, and 10 of the ’432 patent; claims 1 and 2 of the ’243 patent; claims 1, 3, 4, 9-12, and 16-18 of the ’861 patent; and claims 1-5, 8-36, 41-44, 46-68, and 70-79 of the ’444 patent because clear and convincing evidence establishes 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."

In her dissent, Kathleen O’Malley, District Judge, United States District Court for the Northern District of Ohio, sitting by designation, argued that the enablement analysis should have stuck to the specification rather than considering whether Ormco had perfected a commercially successful version of the invention:

An enablement inquiry turns on whether the specification of a challenged patent: “provide[s] sufficient teaching such that one skilled in the art could make and use the full scope of the invention without undue experimentation.” Warner-Lambert Co. v. Teva Pharm. USA, Inc., 418 F.3d 1326, 1337 (Fed. Cir. 2005) (citations omitted). “Furthermore, ‘[w]hether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.’” Id. (quoting In re Wands, 858 F.2d 731, 737 (Fed. Cir.1988)). “Some of these considerations, commonly referred to as ‘the Wands factors,’ include ‘(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.’" Id. (quoting Wands, 858 F.2d at 737).

Here, however, the district court did not examine the specifications to determine whether one of ordinary skill in the art could make and use the invention without undue experimentation. Indeed, there is no indication that the district court considered any of the factors enumerated in Wands. Ormco Corp. v. Align Tech., Inc., No. 03-cv-00016, slip op. at 3-7 (C.D. Cal. Aug. 23, 2004). Instead, Align only produced, and the district court only focused on, evidence of whether Ormco had perfected a commercially successful version of the invention. Commercial success, however, is not determinative of enablement. See CMFT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1338 (Fed. Cir. 2003) ("Title 35 does not require that a patent disclosure enable one of ordinary skill in the art to make and use a perfected, commercially viable embodiment absent a claim limitation to that effect."). I believe, therefore, that the district court’s limited, improper examination of the enablement issue could not have supported summary judgment in Align’s favor on this issue.