## Facts

- Align owned two patents covering orthodontic treatment systems using a series of incremental tooth-positioning appliances with differing shapes for progressive movement.
- Ormco sold a competing incremental appliance system (“Red, White & Blue”), which Align alleged infringed claims in both patents.
- Align sued for infringement in the Central District of California; Ormco asserted invalidity, principally obviousness based on prior art orthodontic practices of Drs. Truax and Rains.
- The district court granted summary judgment that the asserted claims were not invalid, found infringement, rejected inequitable conduct, and entered a permanent injunction.
- Ormco appealed, challenging the validity ruling; the appeal centered on whether the asserted claims were obvious in view of the prior art.

## Issues

1. Whether the asserted claims of Align’s patents were invalid as obvious under 35 U.S.C. § 103(a) in light of prior art incremental orthodontic appliance systems (including Truax and Rains).
2. Whether claimed features such as appliances with different “geometries,” provision of multiple appliances in a “single package,” and inclusion of instructions and change “intervals” were sufficient to render the claims nonobvious.

## Decision

- The Federal Circuit reversed the summary judgment of non-invalidity and held the asserted claims invalid for obviousness under § 103(a).
- The court concluded the prior art taught incremental orthodontic treatment using multiple appliances with differing physical characteristics and similar replacement timing.
- “Single package” limitations were treated as routine packaging choices lacking patentable significance absent a new functional result.
- Instructions limitations were held obvious because medical-device regulations required providing instructions, supplying motivation to include them.
- Overlapping replacement-interval ranges disclosed in the prior art supported obviousness absent evidence of unexpected results.
- Because the claims were invalid, the court did not reach infringement or inequitable conduct.

## Legal Principles

- A claim is unpatentable under § 103(a) if, at the time of invention, its differences from the prior art would have been obvious to a person of ordinary skill in the art.
- Prior art that teaches the core functional concept of the claimed invention can render claims obvious even if the patentee characterizes claim terms (e.g., “geometries”) as more specialized.
- Packaging or distribution choices (e.g., providing components together in one package) generally do not confer patentability without a new functional interaction or result.
- Compliance-driven elements may be obvious where regulatory requirements supply motivation to include the claimed feature (e.g., instructions for use for medical devices).
- Overlapping or closely adjacent numerical ranges disclosed in the prior art strongly support obviousness unless the patentee shows unexpected results for the claimed range.
- Secondary considerations such as commercial success require a demonstrated nexus to the claimed features; success attributable to unclaimed or non-novel aspects carries little weight.

## Conclusion

The Federal Circuit held Align’s asserted orthodontic appliance claims obvious because the prior art already disclosed incremental appliance therapy with comparable appliance variation and change timing, while claimed packaging and instruction features were routine or regulation-driven and Align’s secondary-considerations evidence lacked a nexus to the claimed limitations.


Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299 (Fed. Cir. 2006)