Ormco v. Align Technology (Fed. Cir. 2006).
Align owns a couple of patents covering a system of using a series of sequential orthodontic retainers. Each retainer in the series is used to shift the teeth a bit. Claim 1 is typical and, according to the CAFC:
essentially requires (a) three or more appliances with geometries selected to progressively reposition teeth; (b) instructions regarding order of use; and (c) provision of the appliances in a single package to the patient.
On summary judgment, the patent was found not invalid and infringed. The defendant appealed on obviousness and won.
The opinion is interesting because the court gives only lip-service to the requirement of proof of motivation to modify the the teaching of prior art to achieve the claimed invention. The prior art reference taught the progressive retainers, but did not teach the single package provisioning limitation. The only motivation modify provided by the court is as follows:
Under these circumstances, we do not think that the single package limitation makes the device of the ‘611 patent claims patentably distinct. Providing the devices to the patient in one package, as opposed to two packages or three packages is not a novel or patentable feature in the light of the well-known practice of packaging items in the manner most convenient to the purchaser.
The prior art reference actually appeared to teach away from the single package provisioning by stating that each subsequent retainer should be applied by a professional in an office visit. Here the court dismissed that argument because the supposed teaching away of the prior art (requiring a professional visit for installation) does not necessarily mean that all of the retainers cannot be all packaged together. Although not explicit, this decision appears to diverge from the traditional thought of teaching away as a “suggestion” or implication and moves it to a world where the teaching away is explicitly and definite.
Regarding the instruction limitation — that limitation will never make an invention patentable in the medical field:
statutes and regulations promulgated under the Food, Drug, and Cosmetic Act ("FDCA") generally require instructions for medical devices. Whether or not these regulations apply to the specific orthodontic devices involved here, they supply ample evidence of a motivation to provide instructions as to how to use the devices.
Note: The timing of this case is exceptional. As the respondent and oppositional amici in KSR are preparing their briefs, this decision appears showing the flexibility of the modification test and its ability to allow the court to bend over backwards to achieve the right results. . . .