Ivera Medical Corporation v. Hospira, Inc.


Docket No. 2014-1613, 2014-1614

NEWMAN, REYNA, TARANTO
September 8, 2015

Brief Summary: DC grant of SJ that the disputed patents are invalid for obviousness reversed as “Ivera established a genuine dispute over whether one of ordinary skill in the art would have been motivated to add a vent to the disinfecting cap described in” the prior art.

Summary: Ivera appealed DC grant of SJ that US 7,780,794; 7,985,302; and 8,206,514 related to cleaning devices (i.e., caps containing cleaning materials) for medical implements such as catheters were invalid for obviousness. Typically, catheters and the like are swabbed prior to use with cotton gauze soaked in a cleaning agent such as isoproplyl alcohol, packaged in foil to prevent evaporation. The claimed invention of the patents relate to caps “include a ‘second opening’, ‘aperture’ or ‘means for venting’ that inhibit pressure buildup and allow for evaporation” (representative claim 13 of the ‘794 patent). The DC construed these terms (including first opening), defining “means for venting” under 35 USC § 112, para. 6; these definitions were not challenged. In granting SJ, the DC concluded the “patents-in-suit contain the same elements that perform the same functions they had been known to perform in the prior art”, the “arrangement of elements in the asserted claims do[es] not yield anything other than predictable results”, “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”, and that any secondary considerations were not persuasive. The FC panel agreed with Ivera that the “record evidence establishes a genuine dispute over whether a person of ordinary skill would have been motivated to add a vent to [the prior art’s] disinfecting cap” (including expert declarations and an inventor declaration not considered during prosecution but raised at the SJ stage without objection by Hospira (while “statements of an inventor are not controlling as to the content of a patent application”, Hospira did not challenge inventor’s assertion that he is a person of ordinary skill)). The opinion also explains that the interpretation of certain prior art references is disputed, “neither side points to any other evidence favoring one interpretation”, and this factual dispute must be resolved in Ivera’s favor at the SJ stage (Plantronics, FC 2013). The FC panel concluded “Ivera established a genuine dispute over whether one of ordinary skill in the art would have been motivated to add a vent to the disinfecting cap described in” the prior art, and therefore reversed the DC grant of SJ.

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