Single Packaging Not Patenably Distinct

In Ormco Corporation, et al. v. Align Technology, Inc. (August 30, 2006), the Federal Circuit considered whether claim 1 of U.S. Patent No. 6,554,611 claiming

(a) three or more dental appliances with geometries selected to progressively reposition teeth,
(b) instructions regarding order of use, and
(c) a single package for provision of the appliances to the patient

would have been obvious in view of Dr. Truax's practice of preparing multiple appliances along with the regulations of the Food and Drug Administration ("FDA") that generally require the provision of instructions with medical devices. Even though Dr. Truax created several appliances at one time, with the required geometries, Align contended that Dr. Truax never provided his patients with all these appliances in a single package, and that it would not have been obvious to vary Truax in this respect.

According to Circuit Judge Dyk,

A claim can be obvious even where all of the claimed features are not found in specific prior art references, where "there is a showing of a suggestion or motivation to modify the teachings of [the prior art] to the claimed invention." SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1356 (Fed. Cir. 2000) (concluding that patent would have been obvious in light of teachings in prior art which provided motivation and suggestion to modify existing techniques to arrive at method in question). "A suggestion, teaching, or motivation to combine the relevant prior art , 441 F.3d 977, 987-88 (Fed. Cir. 2006) (quoting 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 of 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.’" In re KahnIn re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000)).

However, a reference that "teaches away" from a given combination may negate a motivation to modify the prior art
to meet the claimed invention. See, e.g., Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). "A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction
divergent from the path that was taken by the applicant." In re Kahn, 441 F.3d at 990 (quoting In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994)) (internal quotation marks omitted).

Align points out that Dr. Truax examined each patient’s progress before giving that patient a new appliance, and that the Truax reference thus does not provide a motivation or suggestion to provide the appliances at one time. Indeed, Align contends, the Truax reference teaches away from providing all appliances at one time. When Dr. Truax was asked whether he
ever gave patients more than one appliance at a time, he replied, "No, because we want to manage it . . . . [I]t would be ridiculous" to expect the patient to replace appliances on his own. J.A. at 6365. He explained that he provided patients with one appliance at a time because in his view "[s]omeone that knows what they’re doing [i.e., the orthodontist] . . . can see the [tooth] movements [and determine when to change appliances based on those tooth movements]. . . ," so as to prevent the patient from moving too quickly through appliances. Id. In
other words, Truax taught that the treatment was more effective if the orthodontist determined when to change appliances, rather than providing several appliances to the patient and allowing the patient to change from one appliance to the next.

The patented device here (and Truax) avoided the necessity for adjustment by the dentist by the use of multiple appliances that were changed periodically. Align asserts that there is an important difference between the patented device and Truax in that the patented device avoids a visit to the dentist in order to determine when substitution of the new device is appropriate. But there is nothing in the claim language that requires the devices be substitutable by the patient. In other words, the claims do not require that the device be capable of replacement by the patient rather than the dentist, or preclude visits to the dentist during the treatment regimen. Indeed, the specification makes quite clear that the patient may periodically visit the dentist during treatment. The claim does not preclude returning to the dentist to determine the appropriate time to replace appliances, just as Truax taught.

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.

We also think that adding the instructions limitation does not
render claim 1 of the ‘611 patent non-obvious. The parties dispute whether Dr. Truax provided instructions to his patients regarding the order of use of the appliances. However, Align conceded at oral argument that the general practice of providing instructions on how to use a medical device would have been
obvious. Furthermore, 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.

Claims 2, 3, and 7, which depend from claim 1, are also invalid. These claims simply add further limitations that were met by Dr. Truax’s practice or would have been obvious variations thereof, and the claims including these limitations would have been obvious.