definiens: means ( a ) passive, diffusion - mediated delivery of one or more therapeutic or prophylactic agents into or through the skin from a Microprojection System, which Microprojection System is coated with such therapeutic or prophylactic agents ; or ( b ) diffusion­mediated delivery of one or more therapeutic or prophylactic agents into or through the skin by way of pathways formed by a Microprojection System . For clarity, the Field does not include any other applications of Microprojection Systems, such as ( i ) delivery of therapeutic or prophylactic agents into or through the skin utilizing a Microprojection System in combination with any delivery system that utilizes a driving source ( including, but not limited to, delivery systems that utilize one or more driving sources such as electrical potential gradients, sound waves, heating systems, laser energy, hydraulic systems or radio waves ), other than as provided by the microprojections, the therapeutic or prophylactic agent itself or chemical permeation enhancers, or ( ii ) the use of a Microprojection System for sampling or sensing