T 2253/14 26-01-2018

Main request

1. Admission

1.1 During the oral proceedings the board reiterated its objection that in claim 1 of the then pending main request the mycotoxin was narrowly defined, i.e. as a trichothecene mycotoxin, in the context of the intended use, whereas it was more generally defined, i.e. as a mycotoxin, when it was to be taken up by a Saccharomyces yeast. A similar discrepancy was present in claim 13 as regards the treatment of a disease caused by a mycotoxin.

1.2 The appellant then filed a new main request in which the subject-matter of claims 1 and 13 was amended such that the term "mycotoxin" was replaced by the term "trichothecene mycotoxin" (see point VIII above). As suggested by the respondent, claim 8 too was amended accordingly.

1.3 The respondent did not raise any objection to the admission of the new main request into the appeal proceedings, and the board had no reasons not to admit it, in particular as the clarity objection against claim 13 only emerged during the discussion in the oral proceedings.

2. Article 123(2) EPC - amendments

2.1 The respondent's objection as to added matter was directed to the amendment of granted claim 1, namely the insertion of the intended use "for reducing the toxicity of a trichothecene mycotoxin". Thus, this objection is an objection under Article 123(2) EPC and not under Article 100(c), as originally argued by the respondent.

2.2 However, the limitation of the mycotoxin class to trichothecene mycotoxin clearly and unambiguously derives from the application as filed. Reference is made to page 11, lines 1-2, which discloses:

"The mycotoxin can be any mycotoxin. Preferred mycotoxins include ... , a tricothene such as Deoxynivalenol ...".

2.2.1 The board acknowledges that this passage discloses the term "tricothene" and not "trichothecene". However, as the opposition division correctly noted, the reference to "tricothene" is an obvious mistake because Deoxynivalenol, which in the cited passage is disclosed as an example of a tricothene mycotoxin, in fact belongs to the class of trichothecene mycotoxins. In this context, reference is made to D12 (page 8, table 1-1, and page 15, table 1-4), D19 (page 380, right column, line 8 from the bottom, and page 382, table I) and D21 (page 699, right column, lines 4-5 from the bottom). The board confirms that the correction offered by the appellant under Rule 139 EPC and accepted by the opposition division is indeed the only possibility available to the skilled person when considering common general knowledge. This is indeed in conformity with the stringent condition to be applied when examining the correction of an obvious error, as mentioned in T 581/91 (Reasons 3, penultimate paragraph), and not in contradiction with that decision as alleged by the respondent. In the present case the correction under Rule 139 EPC was allowed not on the balance of probabilities - the circumstances of which had been criticised in T 581/91 - but on a more rigorous standard, i.e. the obviousness of the correction in the sense that it is immediately evident that nothing else would have been intended than what is offered as the correction.

2.2.2 The respondent argued that, even if the correction offered by the appellant were accepted, this resulted in an intermediate generalisation because the application as filed referred only to Deoxynivalenol. The board does not agree. The application as filed discloses Deoxynivalenol as an example of the wrongly cited class tricothene/trichothene mycotoxins (page 1, lines 20 and 31; page 6, lines 32-33; page 11, line 2). The error is clearly not limited to this example only, but relates to the class in general. Thus the amendment is not the result of an intermediate generalisation.

2.3 The intended use of the claimed composition directly and unambiguously derives from the application as filed. Reference is made to page 10, lines 8-9, which discloses that the composition seeks to reduce mycotoxin levels, and to page 10, line 33, which discloses that the method seeks to reduce mycotoxin toxicity. It is therefore obvious that in the context of the composition too, the reduction of mycotoxin toxicity is sought.

2.4 In conclusion, the subject-matter of claim 1 of the main request complies with the requirements of Article 123(2) EPC. The same applies mutatis mutandis to amended claims 8 and 13 of this request, against which the respondent did not raise any objection under Article 123(2) EPC.

3. Article 123(3) EPC - amendments

The subject-matter of the claims of the main request corresponds to a limitation of the subject-matter of the claims as granted and therefore complies with the requirements of Article 123(3) EPC.

4. Article 54 EPC - novelty

4.1 The respondent argued that the disclosure of D9 anticipated the subject-matter of claim 1 of the main request.

4.1.1 D9 discloses a composition for the deactivation of a mycotoxin, which comprises an enzyme preparation manufactured from an inactivated extract of Saccharomyces yeast (claims 1-3; page 4, lines 1-13; page 5, lines 9-20). Deactivation of a trichothecene mycotoxin is achieved when a specific Saccharomyces yeast is used, namely Saccharomyces telluris (page 5, lines 20-25).

4.1.2 The respondent argued that the inactivated cells of the yeast extract in the enzyme preparation of D9 obviously contained enzymes, since the yeast was defined therein as an enzyme-producing (micro)organism (claim 1). Furthermore, it argued that these cells operated as mycotoxin-binding agents and were capable of taking up a trichothecene mycotoxin, since D9 disclosed that they were able to adsorb and partially decompose trichothecene mycotoxins (page 3, lines 6-13).

The respondent argued that since the patent did not provide any definition of the term "taking up", this term should be given its broadest meaning, which ultimately encompassed the "adsorption" of a trichothecene mycotoxin on the cell membrane. The result of this adsorption was that the cell on the one hand took up the mycotoxin and on the other hand bound it and thus also functioned as a mycotoxin-binding agent.

4.2 The appellant did not challenge the respondent's position that the enzyme, the mycotoxin-binding agent and the Saccharomyces yeast were not necessarily present as three separate components in the composition of claim 1. However, it argued that the inactivated cells of the yeast extract in the enzyme preparation of D9 were not capable of taking up a trichothecene mycotoxin as required by claim 1. According to the appellant, this feature rendered the subject-matter of claim 1 novel over the disclosure of D9.

4.3 Thus the novelty issue boils down to whether the inactivated yeast cells of D9 are capable of taking up a trichothecene mycotoxin.

4.3.1 Although it is true that the patent does not contain any explicit definition of the term "taking up" in relation to a trichothecene mycotoxin, such a definition may be implicit in view of the skilled person's common general knowledge. D21, to which the respondent - in another context - made reference, discloses toxin uptake in yeast (page 699, abstract; page 700, left column, lines 14-15 from the bottom), which means that the term at issue was not invented by the appellant but existed and was used in this technical field. Furthermore, contrary to the respondent's allegations, the patent in suit does provide an explanation of what happens to a trichothecene mycotoxin when it contacts a cell of a Saccharomyces yeast and how it is "taken up" by it. Reference is made to paragraphs [0032] and [0033]:

[0032]

"The purpose of the microorganism is to take up mycotoxins ... Once taken up, the microorganism sequesters the toxin, which cannot then be taken up by the host animal. The microorganism's endogenous enzymes may then breakdown the toxins, although this is not an absolute requirement".

[0033]

"The microorganism has the function of physically taking up the toxin to sequester it within the bacterial or yeast cell. In the case of one toxin at least (DON), the toxin is modified in the cell and analogues are released, which are then able to bind to the binders where further enzyme degradation can take place." (underlining added by the board)

Thus, on the basis of the disclosure of the patent in suit considered in its entirety, "taking up" a trichothecene mycotoxin means that the mycotoxin is transported across the cell membrane into the cell.

4.3.2 In order to explain the significance of this term and to further clarify the difference between the yeast cells of D9 and those of the claimed yeast on the basis of their capacity to take up trichothecene mycotoxins, the appellant stated that only some small uncharged molecules, such as oxygen and carbon dioxide, were able to diffuse easily across the cell membrane. Large/complex molecules, such as those of a trichothecene mycotoxin, could be transported across the cell membrane and into the cell only when the cell was alive. Only in live, physiologically respiring yeast cells could such a "taking up" take place, following either a mechanism which uses an energy source, such as ATP, to achieve uptake against a gradient and therefore increase the intracellular concentration of the trichothecene mycotoxin or a mechanism which binds the mycotoxin to a membrane component or carrier for transportation into the cell. The fundamental principle of these uptake mechanisms was that no large or polar molecules could be taken across a membrane against, or creating, a gradient unless the cell was alive, had its membrane intact and was capable of utilising the energy produced by its active metabolism. Inactivated or non-intact cells could not produce energy or binding proteins and therefore were incapable of producing a gradient across the membrane.

4.3.3 Contrary to the live cells of the claimed composition, D9 discloses that the cells of the extract in the enzyme composition were inactivated in a known manner to obtain the release of enzymes (page 4, lines 6-13). In D30, Dr Mann explained that it would have been necessary to disrupt the cell membrane in order to obtain the enzymes that were previously inside the cell. However, this disruption of the cell membrane would prevent the inactivated cell from rejuvenating and subsequently from taking up larger molecules. That is to say that such cells might be regarded as dead. Thus uptake of a trichothecene mycotoxin cannot occur in the inactivated yeast cells of D9, which are no longer metabolically active and are not capable of producing a gradient across the membrane. This was confirmed in the technical evidence of D31 (Annex 1), according to which the concentration of trichothecene does not decrease in the presence of a Saccharomyces yeast extract, but does decrease in the presence of a live Saccharomyces yeast, this effect being explained by its capability of taking up trichothecene mycotoxin.

4.3.4 As the Saccharomyces yeast of the claimed composition is capable of taking up a trichothecene mycotoxin, this composition is novel over the enzyme preparation of D9.

4.3.5 The respondent argued on the basis of D21 that the taking up of trichothecene mycotoxins was not possible because the cells developed defence mechanisms which did not allow it. The board does not agree. D21 does not disclose that the cells of Saccharomyces cerevisae do not take up mycotoxins. It simply discloses that amino acid alterations in specific genes could play a role in trichothecene resistance in plants (page 699, abstract, last four lines) and that resistance to a toxic compound can be achieved inter alia by reducing net uptake (page 700, left column, lines 14-16 from the bottom). Thus this argument of the respondent is rejected.

4.4 During the oral proceedings the respondent acknowledged that D1 did not disclose a Saccharomyces yeast and consequently that it was not relevant for the novelty of the subject-matter of claim 1 of the main request.

4.5 To conclude, the subject-matter of claim 1 of the main request satisfies the requirements of Article 54 EPC.

5. Other independent claims

The respondent did not raise any objection against the subject-matter of the other independent claims, namely claim 7 (a method claim), claim 11 (a product claim), claim 12 (a first medical use claim) and claim 13 (a second medical use claim). As the subject-matter of all these claims refers to the composition of claim 1, which as set out above is novel over D9, the subject-matter of these claims is also novel over this document.

6. Dependent claims

The subject-matter of dependent claims 2-6 and 8-10 corresponds to preferred embodiments of the subject-matter of independent claims 1 and 7, and thus for the reasons given for the subject-matter of the independent claims the subject-matter of the dependent claims too is novel over D9.

7. D20

As none of the parties relied on D20, the board did not consider it necessary to decide on its admission into the proceedings.

8. Remittal

In view of the request of both parties, the board decided to remit the case to the opposition division for further prosecution, in particular in order to assess sufficiency of disclosure and inventive step. The board notes that it is unusual to treat novelty before sufficiency, but accepts the order the opposition division has chosen to deal with the various objections raised in opposition, in particular since sufficiency of disclosure and inventive step appear to be linked in the present case.