Ormco Corporation, et al. v. Align Technology, Inc.

Secondary Considerations Only Relevant to Obviousness If There’s a Nexus Between the Claimed Invention and the Secondary Considerations. 

(Fed. Cir. 2006, 05-1426)

Ormco appealed from the judgment of the U.S. District Court (C.D. Cal.) finding claims of Align’s U.S. Patent Nos. 6,554,611 (the 611 patent) and 6,398,548 (the 548 patent) valid and infringed.  On appeal, the CAFC reversed and found that all claims at issue are obvious and invalid under 35 U.S.C. Section 103(a).

The technology at issue relates to orthodontic devices for moving teeth from an initial configuration to a final configuration, e.g. retainers.  Claim 1 of the 611 patent recites all of the limitations at issue, and is simply stated as follows:

     1. A system for repositioning teeth from an initial tooth arrangement to a final tooth arrangement, said system comprising
     a plurality of dental incremental position adjustment appliances . . . ; and
     instructions which set forth that the patient is to wear the individual appliances in a predetermined order . . . , [and]
     a package . . . wherein the appliances are provided in a single package to the patient. 

Ormco argued that the orthodontic practices and instructions sheets of one Dr. Truax rendered the Align patent claims obvious.  Align argued that the Truax art did not disclose the “single package” or “instructions” limitations of the claims, that the Truax art teaches away from providing all appliance at once, and that the claims were nonobvious in light of certain objective secondary considerations. 

The CAFC held that these limitations were not novel or patentable features.  Packaging items in a manner most convenient to the purchaser is a well-known practice.   Also, statutes and regulations generally require instructions for such medical devices.  Thus, the  “single package” or “instructions” limitations of the claims did not render the claims nonobvious.  The CAFC also found the “teaches away” argument unpersuasive based on its analysis of the express disclosure of the Truax instructions.   

In reaching these conclusions, it is worth noting that the CAFC reiterated the “TSM” test for obviousness (presently on the Supreme Court chopping block in KSR v. Teleflex).  Additionally, the court articulated the analysis for implicit TSM showings.  “A suggestion, teaching or motivation to combine the relevant prior art teachings does not have to be found explicitly in the prior art, but may be implicit.”  “The test for an implicit showing is what the combined teachings, knowledge of one of skill in the art, and the nature of the problem to be solved as a whole would have suggested to one of skill in the art.” 

In considering the Graham secondary considerations for rebutting a prima facie case of obviousness, the CAFC also stated that evidence of commercial success or other secondary considerations is only significant if there is a nexus between the claimed invention and the commercial success.  Here, even though the Align product was commercially successful, the success was related to other factors such as aesthetics and improved comfort, and not the features claimed novel by Align.