8 Jan 2018

T 1252/13 - Not a disclaimer but still violating Art 123(2)

Key points
  • In this case, the claim was amended to include the feature " wherein said at least one type of collagen alpha chain and said human P4H are devoid of an ER retention sequence". This is a negative feature, but not a disclaimer. The application as filed disclosed that "the at least one type of a collagen alpha chain is devoid of an ER targeting or retention sequence". Following G 1/16, this is a negative feature ([12]) and not a disclaimer ([13]) because it "contributes to the technical teaching". 
  • The Board finds the claim as amended to lack basis, because the negative feature is combined with other features in such a way that the combination adds subject-matter. In particular, in the examples, the ER targeting sequence was removed and nothing was said about the ER retention sequence. The patentee's argument that the gene at issue is "is naturally devoid of an ER retention sequence", is found not convincing because the application discloses that  " the at least one type of a collagen alpha chain is devoid of an ER targeting or retention sequence". 

EPO T 1252/13 - link

VII. Oral proceedings before the board took place on 4 and 5 July 2017. In the course of the oral proceedings appellant I withdrew all pending claim requests except for auxiliary request 32.
Claim 1 of auxiliary request 32 reads:
"1. A genetically modified plant or isolated plant cell comprising an exogenous polynucleotide sequence encoding at least one type of a collagen alpha chain and an exogenous polynucleotide sequence encoding human P4H, each of said at least one type of collagen alpha chain and said human P4H being attached to a vacuole transit peptide, wherein said at least one type of collagen alpha chain and said human P4H are devoid of an ER retention sequence and wherein said at least one type of collagen alpha chain is accumulated in a vacuole devoid of endogenous P4H activity."
Reasons for the Decision
Auxiliary request 32 (sole claim request)
Article 123(2) EPC - claim 1
1. The subject-matter of claim 1 is directed to a genetically modified plant or isolated plant cell comprising an exogenous polynucleotide sequence encoding at least one type of a collagen alpha chain and an exogenous polynucleotide sequence encoding human prolyl-4-hydroxylase (P4H), wherein the collagen and human P4H are each attached to a vacuole transit peptide and are devoid of an endoplasmic reticulum (ER) retention sequence.
2. It is undisputed between the parties that the claimed combination of features - that the collagen and human P4H are each attached to a vacuole transit peptide and are devoid of an ER retention sequence - is not explicitly disclosed in the application as filed.
3. At issue is thus whether or not the claimed combination of features can be derived directly and unambiguously, using common general knowledge, from what is explicitly disclosed in the application as filed, i.e. whether the combination is implicitly disclosed.
4. Appellant I indicated a basis in the application as filed for the modifications of the collagen alpha chain, i.e. attached to a vacuole transit peptide and devoid of an ER retention sequence, and submitted that the application as filed disclosed that the same modifications were to be made to both the collagen and the P4H protein (see section VIII above). Therefore, in the following analysis the board will focus first on the modifications in the context of the collagen alpha chain.
"attached to a vacuole transit peptide"
5. The present invention aims at expressing at least one type of a collagen alpha chain and exogenous P4H in a plant so as to enable accumulation of the collagen alpha chain and exogenous P4H in a subcellular plant compartment devoid of endogenous P4H activity (see page 3, fourth paragraph of the application as filed).
[...]


"devoid of an ER retention sequence"
10. As regards the combination of the collagen alpha chain with the absence of ER sequences, the application as filed discloses consistently two alternatives as follows: "the at least one type of a collagen alpha chain is devoid of an ER targeting or retention sequence" (see page 5, sixth paragraph, page 6, penultimate paragraph, and claim 4).
11. Accordingly, the choice to combine the collagen alpha chain with the feature "devoid of an ER retention sequence" represents a further selection. In the board's view, there is likewise no pointer to this particular selection in the application as filed, for the following reasons.
12. The application as filed discloses that "collagen alpha chains natively include an ER targeting sequence which directs expressed collagen into the ER where it is post-translationally modified (including incorrect hydroxylation). Thus, removal of the ER targeting sequence will lead to cytoplasmic accumulation of collagen chains which are devoid of post translational modification including any hydroxylations. Example 1 of the Examples section which follows describes generation of collagen sequences which are devoid of ER sequences" (see page 14, third paragraph).
13. The examples section discloses that the ER targeting sequence was removed from the polynucleotide sequences encoding the collagen alpha chain, thus disclosing the collagen chain as being devoid of its endogenous ER targeting sequence whilst being silent about the collagen being devoid of an ER retention signal (see Examples 1 and 2 and Table 1).
14. Even if the board were to accept that the skilled person is aware of the fact that collagen is naturally devoid of an ER retention sequence, the application as filed directs the skilled person either to the combination of the collagen alpha chain with the feature "devoid of ER targeting sequence" or to the combination with the feature devoid of both the ER targeting and retention sequences, but not to a combination with the feature "devoid of ER retention sequence" only.
Combination of the features "attached to a vacuole transit peptide" and "devoid of an ER retention sequence"
15. According to established case law, the content of an application is not to be considered to be a reservoir from which features pertaining to separate embodiments of the application can be combined in order to artificially create a particular embodiment. In the absence of any pointer to that particular combination, this combined selection of features does not, for the person skilled in the art, emerge clearly and unambiguously from the content of the application as filed (see Case Law of the Boards of Appeal, 8th edition, 2016, section II.E.1.4 and decisions cited therein).
16. As stated above, the application does not direct the skilled person to combine the feature "exogenous polynucleotide sequence encoding at least one type of a collagen alpha chain" with either the feature "attached to a vacuole transit peptide" or the feature "devoid of an ER retention sequence". The claimed combination of features is therefore not directly and unambiguously disclosed in the application as filed.
17. Appellant I submitted that each of the features "attached to a vacuole transit peptide" and "devoid of an ER retention sequence" was individually disclosed in the application as filed and that the claimed combination of the features was understood by the skilled person to be a technical prerequisite to achieve targeting of the collagen alpha chain to the vacuole and was thus unambiguously and directly disclosed for the skilled person.
18. The board does not find this line of argument persuasive for the following reasons.
19. The application as filed explicitly discloses a different combination of technical features to achieve targeting of the collagen alpha chain to the vacuole. Thus, according to the application as filed, the ER targeting sequence normally present in collagen alpha chains is removed such that the collagen alpha chain is then devoid of an ER targeting sequence (see page 14, lines 10 to 16, examples 1 and 2, Table 1). To this collagen sequence - devoid of the native ER targeting sequence - the vacuole transit peptide sequence is fused (see also Figure 2). In other words, for vacuole targeting of the collagen alpha chain the explicit teaching of the application as filed is "devoid of an ER targeting sequence" not "devoid of an ER retention sequence".
20. Appellant I gave no reasons why the skilled person would ignore this explicit teaching in the application as filed and would understand that the collagen chain needed to be devoid of an ER retention sequence whilst the ER targeting sequence was maintained, when the explicit teaching in the application as filed was that the native ER targeting sequence in the collagen alpha chain was removed.
21. Contrary to the submissions by appellant I, the subject-matter of claim 1 therefore does also not correspond to the examples. The claim is directed to constructs with the native ER targeting signal present, while according to the examples these sequences are deleted from the collagen alpha chain (see point 19 above).
22. As regards a basis for the combination of the features "attached to a vacuole transit peptide" and "devoid of an ER retention sequence" in respect of P4H, appellant I indicated the disclosure of the same features in relation to the collagen alpha chain and submitted that in the light of the passage on page 15, fourth paragraph the same modifications were to be made to both the collagen and the P4H protein.
23. However, since the board could not find a basis in the application as filed for the combination of the features "attached to a vacuole transit peptide" and "devoid of an ER retention sequence" with the collagen alpha chain, appellant I's argument cannot succeed, regardless of whether or not the skilled person would have understood from the passage on page 15 of the application as filed that the same modifications were to be made to both the collagen alpha chain and to P4H.
24. The board notes that in any case, also for P4H, the explicit teaching of the application as filed is to remove the ER targeting signal from both P4H subunits and - in addition - to remove the ER retention signal from the P4H alpha subunit (see Example 1 and Table 1). Thus, removal of the ER targeting sequence, or of both the ER targeting and ER retention sequences, is disclosed in the application as filed in the context of P4H, but not removal of only the ER retention sequence.
25. The board concludes from the above that the subject-matter of claim 1 of auxiliary request 32 does not meet the requirements of Article 123(2) EPC. The sole claim request is thus not allowable.
26. In the absence of an allowable claim request the patent has to be revoked.
Order
For these reasons it is decided that:
1. The decision under appeal is set aside.
2. The patent is revoked.

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