Responding perhaps to the briefing now ongoing in the U.S. Supreme Court in the case of KSR International v. Telflex (Case No. 04-1350), the U. S. Court of Appeals for the Federal Circuit has reversed a district court, finding a group of six claims in issue would all have been obvious under 35 U.S.C. § 103. Ormco Corp. v. Align Technology, Inc., Case No. 05-1426 (Fed. Cir., Aug. 30, 2006) (Dyk, J.).
Align Technology is the holder of U.S. Patent No. 6,544,611 (the `611 patent) and U.S. Patent No. 6,398,548 (the `548 patents), which relate to orthodontic devices for moving teeth from an initial configuration to a final configuration. The patents disclose a series of at least three retainers: the first is designed to move a patient’s teeth from an initial position to an intermediate position, the next moves the teeth an additional amount and so on.
The prior art included an orthodontic technique that involved taking a single mold of a patient’s teeth, repositioning the tooth cavities on the mold to their desired positions and making three appliances from the repositioned mold, each with a different thickness. A thinner appliance, which applied less force, was used before a thicker appliance. Patients were given one appliance at a time, with the orthodontist providing instructions to the patients regarding order of use of the appliances. (This is known as the Truax prior art.) A second prior art technique (the Rains prior art) involved the use of a series of three plastic retainers, made one at a time, to incrementally adjust a patient’s teeth. An orthodontist would take a mold of a patient’s teeth and create an appliance based on that mold. The district court ruled on cross motions for summary judgment that the claims of the `611 patent were not invalid in view of the Truax and Rains references. Ormco appealed.
Noting that Dr. Truax promoted his system to other orthodontists through seminars and clinics and distributed his instruction sheet at those clinics, the Federal Circuit agreed that the Truax technique was prior art under § 102(a) (public use), instructing that public use includes "any use of [the claimed] invention by a person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor."
After citing the statutory language of § 103 and the venerable Supreme Court obviousness case, Graham v. John Deere Co., the Court bit through Align’s argument that although Dr. Truax created several appliances at one time, he never provided his patients with all these appliances in a single package and that it would not have been obvious to do so.
The Court noted that a "claim can be obvious even where all of the claim features are not found in a single prior art references, where ‘there is a showing of suggestion or motivation to modify the teachings of [the prior art] to the claim invention.’" Citing its recent decision in In re Kahn, the Federal Circuit explained that the teachings does not have to be found explicitly in the prior art, as "the teaching, motivation, or suggestion may be implicit from the prior art as a whole, rather than expressly stated in the references. … The test for an implicit showing is what the combined teachings, knowledge of one or ordinary skill in the art, and the nature of the problem to be solved as a whole would have suggested to those of ordinary skill in the art."
Align Technology argued that Truax taught away from providing all appliances at one time and that it would not have been obvious to provide all appliances to a patient in a single package. The Federal Circuit, after noting that Truax, like the patented device, avoided the necessity for adjustment by the dentist by the use of multiple appliances that were changed periodically, found nothing in the claim language that required the devices be substitutable by the patient or that precluded visits to the dentist during treatment. In its decision, the Court noted, "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."
As for the "instructions limitation," the Court noted that the Federal Food, Drug and Cosmetic Act (FDCA) generally requires instructions for medical devices and that, "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."
After again paying homage to Graham, the Court chewed up Align Technology’s argument that any prima facie obviousness is negated by the commercial success of its product that practiced the invention. As the Court noted, "[e]vidence of commercial success, or other secondary considerations, is only significant if there is a nexus between the claimed invention and the commercial success." Here, although Align Technology’s product was commercially successful, the Court found that the presumption that the success was due to the claimed and novel features had been rebutted since Align Technology’s own witness testified that commercial success was due to unclaimed or non-novel features of the device — the aesthetic appeal and improved comfort of transparent devices lacking brackets and wire, as well as the computerized design and manufacture of the appliances.
Practice Note
The Federal Circuit cited both the statute (§ 103) and the Supreme Court decision in Graham — and provided a footnote citing five Federal Circuit cases where a claimed invention had been held invalid for obviousness. This may reflect a sensitivity at the Federal Circuit over the ongoing briefing at the Supreme Court in the case of KSR v. Teleflex where the "motivation-suggesting-teaching" requirement, a mainstay of Federal Circuit jurisprudence for 20 years, is under attack as being a non-statutory requirement that is too rigidly applied by the Federal Circuit. In KSR,the Federal Circuit reversed a district court finding directed to the combination of a movable pivot automobile accelerator pedal with a throttle position sensor controlled engine management system based on what it believed to be an insufficient application of the MST requirement.
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