A Dose of Reality Can Treat Infectious Hindsight

In Ivera Medical Corp. v. Hospira, Inc., [2014-1613, 2014-1614] (September 8, 2015), the Federal Circuit reversed the district court’s summary judgment of invalidity of U.S. Patent Nos. 7,780,794, 7,985,302, and 8,206,514, directed to a medical implement cleaning device.  One embodiment of the device was a threaded cap containing a cleaning material that contained a cleaning agent.  The invention as a vent in the cap “to allow evaporation of the cleaning agent from the inner cavity and to inhibit a buildup of pressure in the cap when the cleaning material is compressed.”  The district court said that a person of ordinary skill would not “need the benefit of hindsight to realize that adding a vent would relieve possible pressure on the inside of the cap.”  The district court found that a person of ordinary skill would recognize the benefits of adding a vent as allegedly taught in the prior art.  The district court concluded that there was no triable issue of material fact on obviousness for the asserted claims of the patents-in-suit.


The Federal Circuit summarized the role of motivation to the obviousness determination:

“A party seeking to invalidate a patent on obviousness grounds must demonstrate by clear and convincing evidence that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.”

The Federal Circuit explained that determining “motivation” is a flexible inquiry, and the motivation is not required to be found in any particular prior art reference.  While Hospira pointed to benefits of venting described in the prior art,  and in the written description of the patents in suit, Ivera pointed to evidence (Declarations from the inventors of the prior art patents)  that the conventional wisdom among those skilled in the art was that disinfecting caps should be fluid tight.  The Federal Circuit agreed that record evidence establishes a genuine dispute over whether a person of ordinary skill would be motivated to add a vent to a prior art disinfecting caps.

Ivera succeeded in creating a factual dispute by showing what members of the prior art actually believed at the time of the invention, providing declarations from the named inventors of two of the prior art references, both of whom explained that their goal was to provide a fluid tight seal, not venting.  Although the statements of an inventor are not controlling as to the content of a patent application, Hospira did not challenge that the inventor was a person of ordinary skill in the art.

Ivera shows the value of presenting an accurate picture of the state of the art, and those of ordinary skill working in it, to combat the tendency of hindsight to make simple inventions appear to be inevitable.