T 181/08 – Coverage

Both the patent proprietor and two of the three opponents filed an appeal against the decision of the Opposition Division to maintain the opposed patent in amended form.

The Board found the requests on file not to comply with A 123(2):

[2.1] Claims 1 of all these requests contain differing or additional features with respect to claim 1 as granted and with respect to claim 1 as originally filed.

[2.2] Claims 1 of all requests concern an oral pharmaceutical multiple unit tableted dosage form comprising

• an enteric coating layer having a thickness of more than 20 μm and said layer
• comprising a plasticizer in an amount of 15-50 % by weight of the enteric coating layer polymer.

Both features are not contained in claim 1 as originally filed. They are derived from the description as originally filed, namely page 15, lines 18 to 23 and lines 10 to 12:

Claim 1 of the second auxiliary request contains a further feature which is also taken from the description as originally filed, i.e. page 16, lines 29 to 30:

As can be seen with regard to this further feature as an example, there are even more parameters in the description than thickness of the enteric coating layer or amount of plasticizer referring to multiple values and characterised by being “usual”, “preferred” or “more preferred”

Under these circumstances, the person skilled in the art reading this description firstly finds no guidance with which of the preferred features to start and secondly which of the other features to combine.

[2.3] Therefore, the combination of the two features “thickness of enteric coating layer of more than 20 μm” and “an amount of 15-50 % by weight of the enteric coating layer” is not directly and unambiguously disclosed in the application as originally filed and claims 1 of all requests containing this combination are in breach of A 123(2).

[3] In addition to the arguments and conclusions set out under point [2] above which lead to the consequence under point [2.3], for the sake of taking account of all arguments presented by the appellant (patent proprietor), the following remarks are added:

[3.1] As a supporting argument, it was mentioned that all the examples covered the “20 μm” and “15-50 % by weight” combination of features.

This remark could put the case close to that of cited decision T 330/05 in asserting that “coverage” by all the examples at least put particular weight on an embodiment carrying one of these features and that this weight would enable the skilled person to directly and unambiguously derive the combination of these features by starting at the particularly weighted embodiment und adding the further feature directly by selecting it from a single list.

However, there is neither particular reference to the amount of plasticizer being in the range of “15-50 % by weight” in each of the examples (the values even have to be figured out by the reader himself and are not indicated as such and, in addition, at least also lie above 10%, one of the other alternatives on page 15 of the description) nor is there any mention of the thickness of the enteric coating layer in any of the examples, except example 15, and there, the thickness is not defined as representing “more than 20 μm” but only corresponding to “approx. 20 μm” which usually also includes a thickness slightly less than 20 μm.

Thus, the appellant (patent proprietor)’s argument that – following the language in T 330/05 – a “most preferred embodiment” based on

• either the enteric coating layer having a thickness of more than 20 μm or
• said layer comprising a plasticizer in an amount of 15-50 % by weight of the enteric coating layer polymer

could be derived from the examples to start with and then simply the second feature had to be added, cannot be followed.

[3.2] The argument that there was no selection from lists leading to totally different embodiments for each item as selected also cannot hold.

Narrowing down parameters or percentages of ingredients of compositions as used in current claims 1 does not in fact result in different products in terms of chemical structure. In any case, however, it results in products carrying different characteristics that, in case of doubt, create a difference with respect to products of the state of the art - which is usually precisely why such “narrowing down” of parameters and percentages is introduced into claims.

[4] Thus, amended claims 1 of the main request and of the first to third auxiliary requests represent subject-matter extending beyond the content of the application as originally filed (A 123(2)).

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