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Providing Retainers in a Single Package with Instructions Did Not Render Patented System Nonobvious

August 30, 2006

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Last Month at the Federal Circuit - September 2006

Judges: Schall, Gajarsa, Dyk (author)

[Appealed from: C.D. Cal., Judge Taylor]

In Ormco Corp. v. Align Technology, Inc., No. 05-1426 (Fed. Cir. Aug. 30, 2006), the Federal Circuit reversed the district court’s grant of SJ that Align Technology, Inc.’s (“Align”) U.S. Patent Nos. 6,554,611 (“the ’611 patent”) and 6,398,548 (“the ’548 patent”) were not invalid. The Federal Circuit held that the asserted claims of those patents would have been obvious in view of the prior art.

Ormco Corporation (“Ormco”) filed suit against Align, alleging infringement of its patents, and Align counterclaimed for infringement of its own patents. Align’s ’611 and ’548 patents are directed to a series of retainers used for aligning teeth that may be switched in and out by a patient. The district court granted SJ of noninfringement and invalidity of Ormco’s patents, but held that certain claims of Align’s ’611 and ’548 patents were infringed and not invalid.

On appeal, Ormco contended that the asserted claims of Align’s ’611 and ’548 patents were invalid because they would have been obvious in view of Dr Truax’s orthodontic practice and an instruction sheet he distributed to orthodontists. Thus, Ormco relied on “knowledge or use by others” that is corroborated by documentary evidence. First, the Federal Circuit determined that Dr. Truax’s system and instruction sheet were sufficiently publicly accessible to qualify as prior art. In reaching this decision, the Court noted that it was undisputed that Dr. Truax promoted his system to other orthodontists through seminars and clinics, and distributed his instruction sheet at those clinics.

Next, the Federal Circuit held that the asserted claims of the ’611 and ’548 patents were obvious in view of Dr. Truax’s system and regulations of the FDA, which generally require the provision of instructions with medical devices. Claim 1 of the ’611 patent 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.

Dr. Truax’s orthodontic system used several clear plastic appliances of different thicknesses that fit over the patient’s teeth. In the district court’s view, the different thicknesses of Dr. Truax’s devices did not qualify as different “geometries,” as required by claim 1. The Federal Circuit disagreed, noting that the specification did not define the term “geometry” and, therefore, it was appropriate to look to dictionary definitions. Based on such definitions, the Court concluded that “geometry” means “configuration” or “shape.” Because objects of different thicknesses plainly have different configurations or shapes, the Court concluded that the Truax devices satisfied the “geometries” limitation of claim 1.

The Federal Circuit also disagreed with the district court’s conclusion that the “single package” limitation of claim 1 of the ’611 patent merely requires that devices be “capable of” being provided to the patient in a single package. The Court concluded that in similar contexts, its cases have rejected claim constructions that would merely require that infringing devices be capable of being modified to conform to a specified claim limitation.

Align further contended that Dr. Truax never provided his patients with several appliances in a single package, and that it would not have been obvious to vary Truax in this respect. Indeed, Align contended that Truax taught away from providing all appliances at one time, because Dr. Truax taught that the treatment was more effective if the orthodontist determined when to change the appliances, rather than providing several appliances to the patient and allowing the patient to change from one appliance to the next. The Federal Circuit rejected Align’s arguments, noting that there was nothing in the claim language that requires the device be substitutable by the patient. Indeed, the specification made clear that the patient may periodically visit the dentist during treatment. Thus, the Court concluded that “[p]roviding 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.” Slip op. at 16.

The Court further concluded that the instructions limitation did not render claim 1 of the ’611 patent nonobvious. The Court noted that Align conceded at oral argument that the general practice of providing instructions on how to use a medical device would have been obvious. Furthermore, FDA statutes and regulations generally require instructions for medical devices. Thus, the Court found ample evidence of a motivation to provide instructions as to how to use the devices.

With respect to a dependent claim that required that at least some of the appliances be marked to indicate their order of use, the Court found that the thicknesses of Truax’s devices served as markings to indicate their order of use, thus rendering the dependent claim obvious in view of Truax.

The Court next turned to Ormco’s argument that claim 17 of the ’548 patent would have been obvious in view of Truax. Claim 17 adds the limitation “wherein the appliances are successively replaced at an interval in the range of 2 days to 20 days.” The Court first rejected the district court’s conclusion that this limitation requires that the devices be “capable of” being replaced within a two- to twenty-day interval. The Court stated that “[m]ethod claims are only infringed when the claimed process is performed, not by the sale of an apparatus that is capable of infringing use.” Id. at 19. Thus, the Court held that the claim requires that the device actually be replaced within the specified period.

The Court then noted that Dr. Truax’s instruction sheet clearly indicated that the appliances are to be replaced every fourteen to twenty-one days, which substantially overlapped the claimed two- to twenty-day interval, and thus there was a presumption of obviousness. Moreover, Align did not rebut that presumption by showing that Truax teaches away from the claimed range or that the claimed range produces new and unexpected results. Thus, the Court held that the claimed range was obvious in view of Truax.

Finally, the Court rejected Align’s contention that secondary considerations supported the district court’s finding of nonobviousness. Although it was undisputed that Align’s Invisalign product was commercially successful, the Court found that the evidence clearly rebutted the presumption that the Invisalign’s success was due to the claimed and novel features. The Court found that, in large part, Align’s witnesses testified that the commercial success was due to unclaimed or non-novel features of the device. Although Align’s witnesses also suggested that the commercial success was due to reduction in time spent in the dentist’s chair, the Court held that “to the extent that such a time savings was the result of the use of multiple appliances (rather than a single device requiring individual adjustment), that feature was not new; Truax had already accomplished this.” Id. at 23. And to the extent that the time savings resulted from the patient’s substitution of a new device without visiting the dentist, that feature was not claimed. Thus, the Court concluded that the evidence did not show that the commercial success was the result of claimed and novel features. The Court thus held that the claims at issue in the ’611 and ’548 patents were invalid as obvious and, therefore, reversed the district court’s finding that the claims were valid.