Case No. IP-2019-000196

91.Waisel is relied on by Hamilton to allege that claim 1 lacks novelty, or failing that inventive step.92.Waisel describes a system using a closed-loop, computer controlled, algorithm that allows automated changes to PEEP and FiO2. The system is referred to by the acronym PEFIOS.93.The therapy adjustments to PEEP and/or FiO2 are based on the condition of the patient and are done by reference to a look-up table. The table has four therapy levels: rapidly and slowly increasing, and rapidly and slowly decreasing. Novelty 94.Professor Tehrani argued that the attack of novelty fails for the same two reasons advanced against Anderson: no disclosure of adjustments to PEEP and FiO2 for each breath of the patient and no disclosure of keeping the PEEP FiO2 ratio within a prescribed range.95.The first point does not succeed because claims 1 and 45 cover the circumstance of adjusting PEEP and FiO2 at greater intervals than every breath. It is not necessary for me to decide whether the control signals in Waisel are sent to the ventilator sufficiently frequently to set PEEP and FiO2 for each breath, although on my reading of Waisel that may well be the case.96.The look-up table for each of the four alternative tiers of therapy in Waisel contain instructions on how PEEP and/or FiO2 should be adjusted depending on (a) the patient’s oxygen saturation, (b) the current FiO2 and (c) the current PEEP.97.Figure 2 shows graphically the spread of PEEP and FiO2 combinations which are acceptable to the system, what Waisel calls the “therapy continuum”. 98.The PEFIOS system ensures that the PEEP/FiO2 ratio is maintained within, or brought within that range of ratios defined by the therapy continuum. Counsel for Hamilton made this more explicit by annotating Figure 2 to show ratios which can be derived from Figure 2: 99.In my view, the skilled person would understand that Figure 2 of Waisel is clearly and unambiguously presenting a prescribed range of PEEP/FiO2 ratios within which the ascertained PEEP and FiO2 values will be kept, or within which they will be brought.100.Figure 2 states that the therapy continuum shown relates to the quickly decreasing therapy level. The small plus sign shows where the patient is located in the continuum, so this may mean that there is a single continuum for all four therapies and depending on where the patient is located by reference to their condition, one of the four therapy levels will apply. On the other hand, it is not made clear that the same continuum would apply for all four other therapy levels. But at least when the PEFIOS system is being used for quickly decreasing therapy it falls within claim 1 of the Patent.101.Claim 1 lacks novelty over Waisel.