Key points
- Application filed in 2021, appeal decision on the grant on 08.01.2024. Things could be improving.
- "Claim 1 of the main request related to:
"A trace element solution, which comprises at least the following metals: (a) zinc in a concentration of at least 60mg/ml; (b) manganese in a concentration of at least 10mg/ml; (c) selenium in a concentration of at least 5mg/ml; and (d) copper in a concentration of at least 15mg/ml; and which comprises a concentration of the metals of at least 90 mg/ml."
"The application relates to a solution containing trace elements useful for administration to mineral deficient animals such as livestock. It seeks to address the problem of low concentrations of the minerals in injectable solutions, leading to the injection of large quantities, which causes tissue damage and abscesses at the site of injection. The invention aims at providing solutions with suitable composition with high enough concentrations and sufficient ratios and sufficient concentrations of the various metals"
The application discloses a rather specific method of making the solution, by adding various salts in a particular order to water, and also adding EDTA in a specific step.
The closest prior art D1 (see example 6) shows a trace element solution
The desirability of a higher metal concentration and the ensuing advantages upon injection are known from D1 (see page 1) and are as such obvious. However, it is apparent that, at the date of filing of the application, there was no obvious way to produce a solution as claimed with a metal concentration of at least 90 mg/ml.
As a quick test, what is the decision you need in such a case?
"the increased concentration of trace elements in solution is obtained [in the application] in particular by a specific order of adding EDTA. The prior art does not allow the skilled person to anticipate that this particular order of addition would lead to the claimed higher concentrations, nor does it appear to suggest any obvious way leading to such high concentrations."
"According to established case law, a product which can be envisaged as such with all characteristics determining its identity including its properties in use, i.e. an otherwise obvious entity, might nevertheless become non-obvious and claimable as such, if there is no known way or applicable (analogous) method in the art for making it and the claimed methods for its preparation are therefore the first to achieve this and do so in an inventive manner "
See T 0595/90 Kawasaki Steel
- These criteria are met.
- "The examining division however found that the criteria of Article 84 EPC were not met"
- "The examining division argued that it was the process of manufacturing, and in particular the specific order of adding EDTA, that provided the trace element in solution.
As a preliminary remark, claim 1 relates to a product per se. Additionally defining this product in terms of the process used for its preparation, i.e. by a product-by-process feature, could only further characterise the composition insofar as this process gives rise to a distinct and identifiable characteristic of the product. In this sense, the steps of the process cannot themselves be regarded as essential features of the product: at most the technical features imparted by this process to the resulting product could represent such essential features."
"The Board understands the examining division's conclusions to be motivated by the finding that the preparation of a trace elements solution with the claimed high concentration could not be achieved in the prior art and was part of the problem to be solved mentioned in the application, and that the process disclosed in the application was the first process to allow such a preparation (as explained above, see 3.2). However this situation does not justify that each and every feature imparted by the process shown in the example to the resulting composition be seen as an essential feature. As explained in T 242/92, the mere fact that only one way of carrying out the invention is indicated does not in itself offer grounds for considering that the application is not entitled to broader claims (see point 3 of the reasons). A lack of support would only arise if there are well-founded reasons for believing that the skilled person would be unable to extend the particular teaching of the description to the whole of the field claimed by using routine methods. The Board sees no such reasons in the present case. In particular, the absence of reference in claim 1 to the EDTA used in the example does not lead to a lack of support, considering that the description mentions EDDS as an alternative, and considering the absence of an indication that the skilled person could not use other chelants."
"For the reasons given above (see 4.1.3), even if, according to the description, the invention aims at providing a highly concentrated trace element solution, and provides for the first time a process allowing the preparation of such a highly concentrated solution, this does not mean that the claims should be limited to that particular process or to a solution defined in terms of that particular process for them to comply with Article 84 EPC."