In a post-KSR world, one of ordinary skill in the art is more clever than he used to be. This case is a reminder that motivation to combine or modify a reference, while required to show obviousness, need not be found expressly in the cited art. Any rational motivation to arrive at the claimed invention is probably sufficient, and will be tough to attack directly. (For more chemical inventions, there is also some good language against obviousness rationales that attempt to apply specific concentrations of one active ingredient to another active ingredient: “[A] person of ordinary skill in the art would have known that one could not simply substitute one active ingredient for another without adjusting the concentration.”)
Background / Facts: The patent at issue is directed to a method for treating allergic eye disease in humans comprising stabilizing conjunctival mast cells by topically administering an olopatadine composition. The specification explains that the discovery that olopatadine can treat human eye allergies through this mechanism of action – stabilizing mast cells in the human eye – is the novel aspect of the patent. Despite similar uses of olopatadine on animals in the prior art, the district court upheld the claims as nonobvious because the prior art did not teach that olopatadine would stabilize conjunctival mast cells in humans.
Issue(s): Whether there was motivation to adapt the formulation disclosed in the primary reference, which was tested in guinea pigs, for use in treating allergic eye disease in humans.
Holding(s): Yes. The motivation to adapt the primary reference’s formulation for human use is that it is an effective antihistamine in guinea pigs and that animal models are (as the district court expressly found) predictive of antihistaminic efficacy in humans. The district court’s fact finding that the prior art did not teach that olopatadine would stabilize human conjunctival mast cells, and indeed taught away from using olopatadine for this purpose, is not clearly erroneous. It is, however, not the only motivation to arrive at the claimed invention. A person of ordinary skill in the art at the time of invention would have been motivated to use olopatadine to treat human eye allergies as claimed for its established antihistaminic efficacy.