The FoodTech Series #1 | Medicament, functional food, nutritive product in the same claim 1: when your own examples no longer support the “improvement”

The Boards of Appeal of the EPO (BoA) are the appeal body that reviews EPO decisions; in this case, they ruled on an opposition appeal relating to a clinical nutrition invention for septic patients.

The real case: You are developing a lipid composition for enteral nutrition for patients at risk of sepsis. At the time of filing, you want “one-time” protection in claim 1: medicament, functional food, or nutritive product, for treatment or prevention. Your argument for inventive step is based on an improvement over the closest prior art.

Claim 1:
“1. Use of a composition comprising at least one lipid which provides between 35% and 75% of the total energy of the composition, the lipid comprising 25% to 70% by weight of total lipid of MCT (medium chain triglycerides), n-6 and n-3 fatty acids in a ratio n-6/n-3 between 2/1 and 7/1, for the manufacture of a medicament, a functional food or a nutritive product for the treatment or prevention of sepsis or inflammatory shock.”

The beginning of the story: The key technical difference from the closest prior art was mainly a higher lipid energy fraction. The patent attempted to substantiate a beneficial effect by means of examples, but these examples did not correspond in practice to claim 1.

The BoA’s teaching: The Board applies a very simple test. If you rely on tests to demonstrate a beneficial effect related to the distinctive feature, the compositions tested must correspond to what is claimed. Here, this was not the case.
Example 1 had an n-6/n-3 ratio of 11.25 and did not contain MCT. Example 2 had a lipid content of 15% of total energy. Example 3 corresponded to claim 1, but had not been tested. In conclusion, no example demonstrated an improvement over the closest prior art.
The alleged improvement is therefore not accepted, the technical problem is therefore reformulated as the simple provision of another drug, functional food, or nutritive product, and the evidence becomes more easily demonstrable, on the basis that adjusting the energy intake of a nutritional composition by increasing lipids is a routine practice.

Practical drafting tip: The broader claim 1 is at the time of filing, the greater the risk of forced limitation during the procedure and the greater the risk that a key parameter of your best example will be excluded from the claim after limitation during the procedure. Before filing, carefully check your key examples, parameter by parameter, against all the characteristics of claim 1. Then do the same check on your preferred fallback positions. This will prevent you from unintentionally excluding the only tested embodiments that supported the improvement if you later have to limit claim 1 to exclude a prior art document.

Disclaimer: This is not legal advice; it is merely practical guidance to be incorporated early on in the filing strategy.

Source: ECLI:EP:BA:2010:T025407.20101129