For the whole decision click here: o40510
Summary
This application relates to a method to quantify the amount of a harmful bacterium in samples taken from humans in a rapid manner using the reaction between the bacterium and a bacteriophage that is specific for this bacterium. The method can be used to determine the initial amount of bacteria in a sample or to determine if this amount of bacteria is above a known threshold level.
The applicant has discovered that if a prescribed amount of parent bacteriophage specific to a bacterium is added to a sample that includes the target bacterium, the time taken to develop an amplified level of progeny phage (or a biological marker associated with the progeny phage) can be correlated quantitatively with the initial quantity of target bacteria in the sample. For a given amount of parent phage added to a sample, the time it takes to develop a characteristic phage (or related marker) level depends on the initial bacterial concentration in the sample. Thus, the concentration of bacteria that was present initially can be deduced from the concentration of phage measured at a specific time.
The Hearing Officer identified the skilled person as a team of a team of microbiologists comprising bacteriologists and virologists with knowledge of the kinetics of the interaction between bacteria and bacteriophage. He held that it was obvious, in light of the prior art and the common general knowledge of the skilled person, to use a calibration curve to determine the amount of initial bacterium in a sample based on a detected amount of progeny phage produced via phage amplification following infection of the bacteria.
The Hearing Officer did not consider that any of the proposed amendments would render the claims inventive. The application was refused for lacking an inventive step.