Intellectual Property Directions

In drafting your claims it is so tempting to take that extra bite out of the apple. You know you want to get a patent issued to stake out market territory and you know what your product goals are. With a public release date looming your patent attorney says you’ve got to file now. Surely it will all be working soon. So what do you file: an application for what you have or an application for what you plan to have?

A Court of Appeals for the Federal Circuit decision from last summer confirmed what you already knew: an invention without enablement is not a [patentable] invention. Align Technologies, the company behind Invisalign® braces, was sued by Ormco Corp. for allegedly infringing a series of patents relating to computer-aided design and manufacture of custom orthodontic appliances.

Ormco’s patent claims seemed to cover the Invisalign system. However, during claim construction (a determination by the judge of exactly what the claims mean) Ormco was told that their claims only covered a process in which final treatment positions are automatically determined (viz., by computer software) whereas the Invisalign system uses “skilled operators” to determine the final positions of the teeth. The judge issued a summary judgement of non-infringement. If that were not bad enough for Ormco, the patent was also declared invalid for lack of enablement.

 How did Ormco wind up with no infringer to sue and no valid patent? Trying to reconstruct the back story, I think this is what happened. Ormco was trying to develop a fully automated system but had a market-ready orthodontic system even without that final computerized step. Anticipating success, they applied for their patent.

At the same time their patent attorneys were doing what is generally accepted to be the best strategy – they filed the broadest claims possible, claims that did not include the limitation of the computerized step. Claims that were ultimately allowed.

Once Ormco was successfully in the marketplace I suspect they gave up on, or at least greatly reduced, their efforts to get the computerized aspect of the system working; after all, dentists were probably just as happy to see a system that required their skilled intervention.

All was well until the Court looked at the specification and the prosecution history and determined that the broad allowed claims must actually be construed as narrowed by requiring a fully automatic process. Apparently, in the specification and history, it was clear that the inventors’ primary basis for distinguishing their invention from the prior art was its high level of automation.

Then, when one of the inventors testified that:

• Ormco had never attempted to create a computerized system that automatically determined tooth positions without human decision making;
• The manual override had been used on all of the approximately forty cases treated using the Insignia product;
• It was a goal to have the software generate final tooth positions that would not require use of the override, [but] variations in human anatomy had prevented the attainment of that goal; and
• [He] was also unsure if the problems due to variations in human anatomy could be overcome,

the invalidity for lack of enablement case was sealed. As the court concluded:

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.

So if you are still making adjustments in your invention when your patent gets filed, be aware that your lack of enablement may let your infringers take a bite out of your market.

This entry was posted on Thursday, February 14th, 2008 at 5:58 pm and is filed under claims, Enablement, Patent Quality. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.