EP 3 331 921 B1 relates to an inulin product.
Brief outline of the procedure
The patent was revoked by the OD for lack of sufficiency as the subject-matter of claims 1 and 7 of all requests was characterized by an amount of chains of fructose units with a terminal glucose of formula GFn with n>=10 which could not be measured.
During the OP the proprietor withdrew their MR=as granted, as well as AR I-VIII and only kept AR IX. AR IX also mentions an amount of GFn>=10.
The board confirmed the revocation.
The contentious point
Inulin compounds having a degree of polymerisation (DP) ranging from 2 to 10 are defined as oligofructoses.
It was necessary to decide whether in order to carry out the invention, the skilled person could determine the amount of sucrose GFn>=10 in the hydrolysed inulin, in particular whether for this purpose the fructose fraction Fm>=11 was negligible, so that the measured amount of compounds having a DP of at least 11 amounted to a measure of the amount of GFn>=10.
The proprietor’s point of view
The proprietor acknowledged that the specification does not describe a method for measuring the amount of GFn>=10 as such.
The proprietor submitted that it was common knowledge, shown in D5 and D23, that the fructose fraction Fm>=11 was negligible, not only for native inulin, but also for the partially hydrolysed product obtained therefrom by action of an endo-inulinase.
The proprietor submitted during OP that it would be also common general knowledge that the commercially available endo-inulinase would only result in the generation of short Fm chains.
In the proprietor’s opinion, the issue of sufficiency of disclosure which hinges on whether the amount of Fm>=11 is negligible is a question about the accuracy of the measuring method and therefore a hidden clarity objection against claim 1.
The proprietor submitted that in such case, for concluding an insufficiency arising out of ambiguity, it is not enough to show that an ambiguity exists, e.g. at the edges of the claims, but it will normally be necessary to show that the ambiguity deprives the person skilled in the art of the promise of the invention.
The board’s decision
The process of claim 1 corresponds to that of granted claim 7. The product obtained is required to have a L value in the range of from 2.20 to 3.0, while achieving an amount of GFn>=10 comprised between 3 and 20 wt.% on the total carbohydrates of the inulin product.
The need to control the hydrolysis of the inulin raw material requires that the skilled person has at their disposal an adequate method for analysing the hydrolysed product, in particular with respect to the amount of GFn>=10.
There are two methods available, for compounds having a DP of 11 or higher, the amount of the mixture of compounds GFn>=10 and Fm>=11 can be determined by
- high-temperature capillary gas chromatography (HGC), or
- (ii) by high pressure anion exchange chromatography in pulsed amperometric detection mode (HPAEC-PAD).
According to the evidence brought forward, these two methods do not separate the GFn from the Fm fractions over the complete DP range, but accepts that a distinction can be made only in the lower DP region <9.
It has not been shown that the partially hydrolysed product obtained from native inulin by action of an endo-inulinase would contain Fm>=11 in a negligible amount compared to the amount of GFn>=10.
The board thus held that the skilled person would be left in the dark as to when to stop the hydrolysis reaction in order to adjust the amount of GFn>=10 over the entire breadth of claim 1.
The amount of GFn>=10 is a structural feature whose meaning is clear and therefore not an unclear parameter. The absence of a reliable measuring method has to be differentiated from the absence of indication for measuring conditions of a reliable method.
The absence of a definition for measuring conditions for a reliable method does not necessarily means that the invention cannot be put into practice.
In such a case, the question to be answered is whether taking the measuring conditions which are conventional in the art for said reliable method, the skilled person is still able to prepare what is claimed taking into consideration that various usual measuring conditions might influence the parametric values measured and therefore the definition of the product to be prepared.
Instead in the present case, at the date of filing no reliable measuring method was available for the skilled person to determine when the amount of GFn>=10 required by the terms of claim 1 has been obtained.
Comments
If one looks at the case law of the boards, there are a number of decisions according to which an unclear parameter, e.g. due to the lack of a measurement method for the parameter amounts to an insufficient disclosure of the invention under Art 83, cf. T 2161/17, or T 1188/15.
If a well-known method exists for measuring a parameter, then sufficiency is given, as common general knowledge can contribute to the missing information.
Looking at another group of decisions of the boards, it appears that an unclear parameter, e.g. due to the lack of a measurement method for the parameter, only amounts to a mere lack of clarity under Art 84, which may not be discussed in opposition proceedings in view of G 3/14, cf. T 1260/16 or T 1627/17. It appears that often G 3/14 is taken as a pretext not to look into the matter.
A good criterion to prima facie distinguish between sufficiency and clarity is whether, in order to overcome the objection, information is contained or not in the original disclosure.
If supplementary information needs to be brought in, then the objection is an objection of lack of sufficiency as the only way to overcome it would be to add matter.
If supplementary information, for instance essential features, is disclosed in the original documents, then objection is an objection of lack of clarity.
In the present case, achieving an amount of GFn>=10, no method was disclosed allowing to know when hydrolysis had to stop.
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