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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-life case: You are developing a lipid
composition for enteral nutrition for patients at risk of sepsis.
When filing your application, you draft a broad claim 1, with
several technical parameters and wide ranges. You also add several
application frameworks in a single claim (medicine, functional
food, nutritional product). 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 compared to 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 the parameters of claim 1.
The BoA’s teaching: The Chamber applies a
simple test. If you rely on tests to demonstrate a beneficial
effect linked 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 MCTs.
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 reformulated as
simply providing another “medicament, functional food or
nutritive product,” and the evidence becomes easier to
demonstrate, since adjusting the energy content 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
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.