Case No. IP-2019-000196

82.Hamilton alleged that claims 1 and 45 lack novelty and inventive step over Anderson.83.Anderson discloses a closed-loop mechanical ventilator. It is stated to be based on well-established protocols to maintain appropriate levels of PEEP and FiO2 in patients with ARDS. It uses a PaO2 sensor coupled to a Mac computer that continuously controls PEEP and FiO2 settings. The system is shown diagrammatically in Figure 2: 84.There are two separate PID controllers, one for each of PEEP and FiO2. Five look-up tables are used to determine whether PEEP or FiO2 is to be changed, which happens if the two are outside approved combinations. Novelty 85.Professor Tehrani advanced two differences between the Anderson system and that of the Patent. The first was that Anderson does not disclose an adjustment of PEEP or FiO2 for the next breath of the patient. That is correct, but I have found that the term “a next breath” in claims 1 and 45 of the Patent covers a breath other than the breath immediately following the determination of FiO2 and PEEP.86.The second difference suggested was that Anderson does not disclose the notion of a prescribed range of PEEP/ FiO2 ratios. In disputing this, Professor Rees drew attention to Figure 3 of Anderson. Figure 3 shows one of the look-up tables, that for a “threatening” set of conditions. There are 6 columns, each one for a different PEEP pressure ranging between 5 and 25 mmHg. There are 8 rows for FiO2 values running from 40 to 100%. Each of the 48 units is marked either “F” for increasing FiO2, “P” for increasing PEEP, “B” for increasing both or “N” for increasing neither. Thus there is a prescribed action (including inaction) for each combination of the 6 PEEP values and 8 FiO2 values. 87.Professor Rees said this in his first report:“213. Anderson discloses a system that determines whether PEEP, FiO2, both or neither should be adjusted based on their relationship to one another as illustrated by the tables in Figure 3 of Anderson. The look-up tables illustrated in Figure 3 are arranged such that change in PEEP moves the settings within a clinically acceptable range towards preferred combinations of PEEP and FiO2 values and therefore the ratio between them. The spread of ratios that would trigger a change in PEEP and FiO2 is quite broad in the table for ‘Threatening’ status; this makes sense as the adjustment is designed to get the patient ‘out of trouble’ and hence it is appropriate that adjustment of both parameters takes place in the majority of cases.”88.In Anderson’s system PEEP and FiO2 are independently controlled. I agree with Professor Rees that Figure 3 indicates that each will be adjusted according to their relationship to one another. I do not, however, accept Hamilton’s argument that this constitutes a clear and unambiguous disclosure of determining PEEP to keep the PEEP/FiO2 ratio within a prescribed range. Nothing in the way of a prescribed range is disclosed.89.Neither claim 1 nor claim 45 lacks novelty over Anderson. Inventive step 90.Professor Rees gave no evidence as to whether, and if so why, the skilled person would contemplate an adjustment to the Anderson system to include a prescribed range of PEEP/FiO2 ratios or how any such adjustment would be approached. In argument Anderson appeared to be treated as prior art only relevant to the novelty of claims 1 and 45. I therefore find that neither claim 1 nor claim 45 lacks inventive step over Anderson.