CABINET CHAILLOT

T1251/16

Article 83 EPC

The opposition division decided that the claim sets according to the main request (claims as granted), in particular claim 9, contravened Article 123(2) EPC and that the claim sets according to the auxiliary requests (first to seventh) contravened Article 83 EPC.
The opposition division revoked the patent.

Claim 1 :
“1. A method of increasing the serum half-life of a protein, comprising:
fusing said protein with one or more unstructured recombinant polymers (URPs), wherein the URP comprises at least about 200 contiguous amino acids, and wherein
(a) the sum of glycine (G), aspartate (D), alanine (A), serine (S), threonine (T), glutamate (E) and proline (P) residues contained in the URP, constitutes more than about 80% of the total amino acids of the URP; and
(b) at least 50% of the amino acids of the URP are not present in secondary structure as determined by Chou-Fasman algorithm; and wherein said URP is substantially incapable of non-specific binding to a serum protein; and
(c) the URP has a Tepitope score equal to or less than -4.”

Main request:
Claim 9 as granted reads as follows:
"9. The method of claim 1, wherein said URP contains only 3, 4, 5, or 6 different types of amino acids selected from the group consisting of glycine (G), aspartate (D), alanine (A), serine (S), threonine (T), glutamate (E) and proline (P)."
The board agrees with the conclusions of the opposition division that claim 9 of the main request adds subject-matter contrary to the requirements of Article 123(2) EPC. In particular, there is no basis for the feature "wherein the URP contains only 3, 4, 5, or 6 different amino acids selected from the group consisting of ... [GADSTEP]".
The appellant indicated paragraph [0121] "in combination with the rest of the application" or possibly paragraph [0113] of the application as filed as constituting a basis for this feature. The relevant passage in paragraph [0121] reads "URPs or the repeats inside URPs often contain only 1, 2, 3, 4, 5 or 6 different types of amino acids". It does not refer to any group of amino acids from which to select the different types of amino acids, and it is therefore interpreted as referring to any possible amino acid. Paragraph [0113], on the other hand, discloses that "Where desired, URPs can be designed to contain (...) sometimes only a few types of amino acid, e.g., two to five types of amino acids (e.g., selected from G, E, D, S, T, A and P)". This passage, while referring to the GADSTEP group, only envisages the use of two to five, rather than three to six (as in the claim), types of amino acids from this group. Hence, the two passages do not provide an adequate basis for the disputed feature.
While the board agrees with the appellant's argument that literal support is not necessarily required for the purposes of Article 123(2) EPC, this does not mean that different passages of the originally filed documents can be freely combined to come up with a teaching that is not unambiguously derivable from the application as filed.
The board thus comes to the conclusion that claim 9 of the main request adds subject-matter contrary to Article 123(2) EPC. The main request is thus not allowable.

Auxiliary request 1
The first auxiliary request differs from the main request in that claim 9 has been deleted.
Being a method claim, the purpose of the method, which is increasing the serum half-life of a protein, is a limiting feature of the claim. Hence, only embodiments that achieve this effect are part of the claim. For the purposes of sufficiency of disclosure, the application must thus provide an enabling disclosure of the URPs as claimed and must also show or at least render it plausible that use of these URPs in a method as claimed achieves the effect of increasing the serum half-life of a protein.
In the board's view, the patent fulfils both conditions. It discloses how to produce URPs with the features as claimed, and it also describes the technical basis for the half-life extension of a protein when using a URP as claimed, thus rendering it plausible that such a URP can be successfully used in a method for increasing serum protein half-life as claimed. Post-published data in documents D32 and D33 confirm that this effect is achieved for two fusion proteins comprising pharmaceutical proteins and a URP according to the invention.

The opposition division reached a decision on Article 123(2) and 83 EPC but did not discuss, let alone decide on, any other of the remaining opponents' objections, namely under Articles 54 and 56 EPC.
Therefore, the case is remitted to the opposition division for further prosecution.

 

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