Brief Fact Summary. Align Technology, Inc. (Plaintiff) sued Ormco Corp. (Defendant) for infringing on its patent ‘611 regarding orthodontic devices.Â Plaintiff developed a series of retainer-like devices to straighten teeth.Â Defendant argued the ‘611 claims would have been obvious and were therefore invalid due to prior art references of another orthodontist having developed a similar system without providing the devices in one package to the patient.Â Plaintiff was granted summary judgment by the district court who found that the patent claims were valid and Defendant was liable for infringement upon those claims.
Synopsis of Rule of Law. Sections 102(a) and 103(a) prohibit patents on claims that would be obvious or anticipated from prior art references unless the patent applicant disproves the finding of obviousness by demonstrating an idea or reason to modify the teachings of the prior art, or secondary considerations, such as commercial success.
Issue. Â Do Â§Â§ 102(a) and 103(a) prohibit patents on claims that would be obvious or anticipated from prior art references unless the patent applicant disproves the finding of obviousness by demonstrating an idea or reason to modify the teachings of the prior art, or secondary considerations, such as commercial success?
Held. (Dyk, J.)Â Yes.Â Sections 102(a) and 103(a) prohibit patents on claims that would be obvious or anticipated from prior art references unless the patent applicant disproves the finding of obviousness by demonstrating an idea or reason to modify the teachings of the prior art, or secondary considerations, such as commercial success.Â Defendant argues that due to prior art references, the ‘611 patent claims were obvious in accordance with Â§Â§ 102(a) and 103(a).Â The first reference is from Dr. Truax, an orthodontist, who developed a system of taking a mold of a patient’s teeth, creating a device to move the teeth to a desired position, and then continuing to mold and move the teeth by using a series of such devices.Â Dr. Truax provided only one appliance at a time, and the thinner appliance was applied before the thicker.Â The second reference is from another orthodontist, Dr. Rains, who practiced a technique that was similar by using a series of three retainers to move a patient’s teeth.Â For the art to be recognized as prior art, it must be accessible to the public.Â Plaintiff argued that Dr. Truax’s materials were only distributed to orthodontists and therefore were not available to the general public.Â However, his instruction sheet was distributed through seminars and clinics to promote the method, and therefore the prior art was sufficiently available to the general public.Â Dr. Truax’s system used different thicknesses instead of different “geometries.”Â The patent specification does not define the term “geometry,” so the dictionary definition will be used, which defines “geometry” as “configuration” or “shape.”Â The Truax devices fit the “geometries” limitation of Claim 1 as differing thicknesses fall within the dictionary definition.Â The court also disagrees with the district court’s finding that the devices are only capable of being provided in a single package.Â Claim 1 requires the devices are provided in a single package.Â Plaintiff claims providing the devices in a single package would not have been obvious from Dr. Truax’s reference.Â The suggestion, motivation, or teaching in the prior art does not have to be found clearly within the prior art.Â However, the prior art cannot “teach away” from the modification to the prior art.Â Plaintiff argues Dr. Truax’s reference does teach away from the single package because he requires the patient have an appointment in order to determine progress and the appropriate time to move to the next thickness.Â In this case, the patient can simply use the next device in the series without requiring a dentist or orthodontist to make adjustments to the devices.Â However, just as Truax taught, the claim references periodic visits to the treating practitioner to ensure proper adjustment.Â Also, while the parties argue whether Dr. Truax provided his patients with instructions, that limitation does not render Claim 1 nonobvious because the Food, Drug, and Cosmetic Act requires that instructions be provided with medical devices.Â Finally, Plaintiff also argues the secondary considerations support a finding of nonobviousness.Â Among other indications, secondary considerations may consist of commercial success, long-felt but unsolved needs, or failure of others.Â While it is true that Plaintiff’s product, Invisalign, has enjoyed great commercial success, even the Plaintiff acknowledges the success is only partly due to the claimed features of its patent.Â Truax had accomplished each of the claimed features before the introduction of Invisalign.Â Similarly, the long-felt but unsolved needs and the failure of others were not resolved or addressed by the claimed features.Â Due to obviousness, Claim 1 and its dependant claims are invalid.Â The finding of infringement does not need to be addressed by the court.Â Reversed.
Discussion. The court is flexible in its application of the modification test, which is different from prior opinions.Â Plaintiff did actually modify the prior teaching of Dr. Truax by providing the three devices to the patient in one package.Â Also, the court did not find that the FDCA specifically required instructions be provided with these particular medical devices, so that was also a potential modification from the prior art