Wednesday, 9 May 2018

T 2070/13 - When is routine work an experimental programme?

An experimental programme

Claim 1 in this opposition appeal requires a combination of  a viscoelastant material and an anti-adherent material. A large number of possibilities for the anti-adherent material is claimed, while the anti-adherent property is not very well defined. The Board found that this is too much for the skilled person. Reasons 1.11 discusses where the burden of proof lies in this case. 
"A topical viscoelastic fluid modifying composition for topical application to the skin and hair in the perianal and/or labial areas comprising at least one viscoelastant material and an anti-adherent material, wherein the composition comprises between 0.01% to 25% by weight of the viscoelastant material and between 0.01% and 25% by weight of an anti-adherent material; wherein the viscoelastant material comprises a material selected from the group consisting of enzymes, linked enzymes, alkyl polyglycosides having 8-10 carbon atoms in the alkyl chain, bovine lipid extract surfactant, dextrans and dextran derivative; and wherein the anti-adherent material comprises a material selected from the group consisting of casein, farnesol, flavones, fucans, galactolipid, kininogen, inulin, iridoid glycosides, perlecan, poloxamer 407, sulphated exopolysaccharides, and combinations thereof."

Reasons for the Decision
1. Main request - Article 83 EPC 1973
1.1 The invention according to claim 1 is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.
1.2 It is firstly noted that materials known to exhibit adherent rather than anti-adherent properties are included within the listed anti-adherent materials in claim 1 (e.g. casein is used as a binder in paints).
1.3 The skilled person is thus in the position of having to establish, without any guidance from the patent, which composition(s) in the defined group of the listed materials exhibit(s) anti-adherence. Not only are 12 materials listed as members of the group, but combinations of these are claimed and, moreover, many of the materials (in particular flavones, fucans, galactolipid, iridoid glycosides, sulphated exopolysaccharides) describe large families of compounds which still further extends the potential materials for inclusion in the claimed composition. In the absence of a test method in the patent for determining the anti-adherence of a material, the skilled person is unable to establish, even qualitatively, suitable materials from the extensive group of materials listed in claim 1 which will meet the claimed anti-adherence.
1.4 Still further, claim 1 does not limit the amount of anti-adherent material to be included in the composition such that this can range from a fraction of 1% to approaching 100%, this adding another level of complexity to the skilled person identifying a suitable anti-adherent material. The skilled person would thus be faced with an experimental programme of unreasonable proportion in order to establish which materials of the claimed group satisfied the claimed anti-adherence.
1.5 The respondent's argument that solely a qualitative, rather than a quantitative, measure of anti-adherence was being claimed could not change the Board's finding. The patent in suit fails to indicate how (qualitatively or quantitatively) or in relation to which test materials and test conditions (humidity, temperature, support structure, test fluid etc.) any degree of anti-adherence can be established. No standard procedure is disclosed in the patent in suit and none was referred to during the whole proceedings.
1.6 The respondent's contention that the visual inspection indicated in D10 of applying a specific fluorescence method would suffice in determining the anti-adherent properties of a material does not overcome the fundamental hindrance faced by the skilled person in having to select appropriate anti-adherent materials from the extensive list of materials in claim 1. The ability to recognise anti-adherent properties per se (in relation to defined conditions concerning material, humidity, temperature) is not questioned, rather it is the number of materials, including families of materials, and at weight percentages of less than 1% to approaching 100% that provides the skilled person with an unacceptable burden when trying to carry out the invention.
1.7 The respondent's further argument that the skilled person could carry out the invention by way of routine optimisation using standard procedures is not convincing. Even if a specific model test procedure were used to determine the anti-adherence, this does not significantly reduce the extent of the experimental programme required to identify the appropriate anti-adherent materials. As indicated above, the sheer number of materials listed in claim 1 for which anti-adherence would have to be determined would necessitate an experimental programme to be set up and performed by the skilled person, irrespective of how the anti-adherence is actually measured. Accordingly, establishing which materials would and which would not satisfy the invention is what leads to the finding that the requirements of Article 83 EPC are not met.
1.8 The same conclusion is reached regarding the 'model systems' of D17, D18 and D19 argued by the respondent as being able to provide an assessment of anti-adherent materials. These 'model systems' were not related to anti-adherence tests concerning the claimed environment (viscoelastic fluid modifying compositions and application to the skin and hair in the perianal and/or labial areas) but were related to the adherence of bacteria to wounds (D17) or to the adherence of yeast to porcine or human skin (D18, D19).
1.9 D16 also fails to provide any guidance as to how anti-adherence may be determined. Firstly, the document was post-published with respect to the patent in suit and its disclosure is thus of no relevance to the sufficiency of disclosure thereof. Even if it were prior art, D16 is only concerned with the inhibition of Pseudomonas aeroginosa attachment and thus discloses no general reference to anti-adherence relevant to the opposed patent.
1.10 Hence, the skilled person is unable to identify suitable materials displaying anti-adherence due to the large number of potential materials listed, several of these listed materials also describing large families of compounds; the skilled person would be faced with an experimental programme in order to establish which of the listed materials satisfied the claimed criterion of anti-adherence. This is particularly the case since the patent also lacks a single example which could be regarded as guidance to the skilled person of a composition satisfying the invention.
1.11 Burden of proof
The board had already indicated in its preliminary opinion that an adequate test method was lacking and that no suitable compounds were defined within the claimed families of compounds. Accordingly, serious doubts were set out concerning whether the skilled person's common general knowledge would be sufficient to enable him to carry out the invention. As a consequence, the burden of proof - which in a first attempt to attack the underlying requirement of the EPC in opposition lies with the opponent - had shifted to the patentee who could rebut these arguments by providing appropriate information and evidence. The mere assumption that anti-adherence of the claimed groups of compounds was known, and the reference to post-published D16 referring to a particular bacterial non-adhesion, is not convincing evidence that could discharge the respondent from its burden of proof with regard to the subject-matter claimed. Also the reference to D10 could not overcome this issue in that D10 - also being a patent specification - fails to disclose a standard test method but rather sets out a very specific test procedure, the relevance of which to the present measurement of anti-adherence cannot be assessed.
1.12 In summary therefore the invention according to claim 1 is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, contrary to the requirements of Article 83 EPC 1973. The main request is thus not allowable.
This decision T 2070/13  (pdf) has European Case Law Identifier: ECLI:EP:BA:2018:T207013.20180412.
The file wrapper can be found here. Photo  by Gerd Altmann (Geraltobtained via PixaBay under a CC0 license (no changes made).

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