T 0188/18 (Preparation of hydrolysed whole grain flour/QUAKER OATS) 18-09-2020

Reasons for the Decision

1. The appeal is admissible.

2. Admission of document D27

Document D27 was filed by the respondent at a late stage in the appeal proceedings. The appellant did not object to its admission since it aided its case. The board had no reason to reject this document either. Accordingly, document D27 was admitted into the appeal proceedings (Article 13(1) RPBA 2020).

Main request

3. Sufficiency of disclosure

3.1 According to established case law of the boards of appeal, an invention is sufficiently disclosed if it can be performed by the person skilled in the art without undue burden in the whole area claimed, using common general knowledge and taking into account further information provided in the description of a patent or patent application. An invention is in principle sufficiently disclosed if at least one way is clearly indicated enabling the person skilled in the art to carry out the invention.

3.2 Claim 1 of the main request is directed to a method for the production of a highly dispersible whole grain flour comprising the steps a) to d) (see point IV above). According to step a), a whole grain flour is hydrolysed using alpha-amylase, the alpha-amylase hydrolyses the whole grain flour while maintaining the integrity of the whole grain; the hydrolysed whole grain flour is heated in a cooking extruder and gelatinised by mechanical action to form a whole grain flour dough, whereby the mixture resides in the extruder for a time sufficient to gelatinise and cook the starch, generally at least one minute, wherein prior to exiting the extruder, the hydrolysed whole grain flour dough is heated to 121 to 149 **(o)C to deactivate the alpha-amylase.

3.3 The board agrees with the opposition division that for compliance with the requirement of sufficiency of disclosure, it must have been possible for the skilled person to reproduce the claimed process and obtain the desired product, which is a highly dispersible whole grain flour. The board also agrees with the opposition division that step a) resulting in the formation of a hydrolysed whole grain flour dough is crucial for the maintenance of the whole grain status in the final product. The skilled person would understand that after the deactivation of the alpha-amylase at the end of step a), no further significant hydrolysis occurs in the subsequent pelletising, milling and agglomeration steps.

3.4 It is undisputed that the outcome of the hydrolysis step can be influenced by a variety of process parameters including, for example, the type of alpha-amylase and its concentration, reaction time, temperature or pressure, pH, etc. It is equally undisputed that the patent in suit contains no working example in which a specific starting material, a specific intermediate product according to step a) and a specific final product is disclosed in combination with a set of specific process parameters for the conversion of the starting material into the desired product.

3.5 The appellant essentially argued that the patent in suit clearly discloses the nature and properties of the starting material, the hydrolysed intermediate product and the final product and contains sufficiently detailed information on the process parameters for the person skilled in the art to have carried out the claimed process. Process parameters which were not explicitly disclosed could easily have been supplemented by the person skilled in the art based on their common general knowledge and their clear knowledge of the intended product.

3.6 As regards the nature and properties of the starting material and the desired product, the appellant relied on paragraphs [0004], [0007], [0010] to [0012], Table 1, and Figures 1 and 2 of the patent in suit.

3.7 Paragraph [0004] characterises the product according to the invention as "hydrolysed whole grain flour that maintains its whole grain structure and nutritional value and is highly dispersible". A similar wording can be found in paragraph [0007], which states that "an enzyme hydrolyzes the whole grain flour while maintaining the integrity of the whole grain". In paragraph [0010], the desired product is defined as "hydrolysed whole grain flour that maintains its whole grain status throughout processing and is highly dispersible in liquid and semi-solid media". This is followed by the statements that, "[T]he whole grain may be any suitable cereal grain such as oat, wheat, corn (maize), rice, barley, rye, quinoa, sorghum, millet, triticale or combination thereof". Subsequently, paragraph [0010] defines the expressions "whole grain status", "whole grain standard of identity", "standard of identity of the whole grain" or "maintaining the integrity of the whole grain", which "shall mean whole grains consisting of the intact, ground, cracked or flaked caryopsis, whose principal anatomical components - the starchy endosperm, germ and bran - are present in the same relative proportion as they exist in the intact caryopsis".

Paragraph [0011] of the patent in suit explains that the (whole grain) flour is hydrolysed using an enzyme that "allows the whole grain flour to maintain its standard of identity as whole grain", for example, alpha-amylase. The enzyme "hydrolyzes the alpha 1-4 bonds on the amylopectin molecules that makes up the starch portion of the whole grain". Furthermore, it is stated that "[T]esting and analysis of whole grain flours, such as wheat flour and oat flour using the method set forth herein has verified and validated that the starch molecules are maintained through processing. The results of such testing are reflected in Figures 1 and 2 and table 1 below". It is also stated in paragraph [0011] that any change of the food constituents is negligible at best.

According to paragraph [0012] "the nutritional backbone of the whole grain flour is maintained throughout processing" and the hydrolysed whole grain flour "provides the same nutritional benefits as un-hydrolysed whole grain flour". No further information regarding the nutritional backbone or benefits are provided.

3.8 Considering the disclosure of the paragraphs mentioned in point 3.7 above, it is the board's view that the person skilled in the art would have been confronted with contradictory requirements. On the one hand, the relative proportions of germ, bran and starchy endosperm are to be maintained to keep the whole grain status, which in the board's and the appellant's view requires that the starch portion is maintained. This is consistent with the statement in paragraph [0011] of the patent that the starch molecules are maintained, i.e. not changed, throughout processing. On the other hand, hydrolysis of alpha 1-4 bonds with alpha-amylase takes place. This breaks down the starch molecules and consequently changes the starch molecules and the starch properties. No information as to the nature of the change is provided in the patent specification.

3.9 According to the appellant, the skilled person would have understood from the disclosure of the patent in suit that the hydrolysis step a) according to the invention breaks down the starch molecules into smaller starch molecules but does not go so far as to convert the starch molecules into smaller molecules, such as oligomers or reducing sugars.

3.10 Although this may be a reasonable assumption to make for the person skilled in the art to reconcile the contradictory requirements of maintaining and hydrolysing, i.e. degrading, the starch molecules, it immediately raises the question as to the degree of change permitted without affecting the integrity of the starch. The board notes that the patent in suit is completely silent in this respect. No criteria are provided in the patent that would have allowed the skilled person to determine if and when the integrity of the starch, and consequently the integrity of the whole grain, was maintained. There is no information on the degree of depolymerisation or the chain length of the hydrolysed starch molecules and no information on any other property based on which the skilled person could have established that the integrity of the starch and therefore the integrity of the whole grain had been maintained.

3.11 Table 1 on which the appellant relied is not helpful in this context. It lists the "%" - the board assumes weight percent - of various components, including starch, of a whole oat flour and a hydrolysed oat flour. However, the disclosure in Table 1 does not allow any conclusion as to the difference between the starch component in the "whole oat flour" (i.e. the unhydrolysed starting material) and the "hydrolysed oat flour". Indeed, in accepting the appellant's argument that the small changes between the whole oat flour and the hydrolysed oat flower observed in Table 1 are within the experimental error of the tests and analysis that had been carried out, the only objective conclusion that can be drawn from Table 1 is that no change in the starch has occurred and therefore no hydrolysis had taken place. This contradicts the disclosure of the patent in suit (see paragraph [0014] and claim 1). Table 1 provides no answer as to the extent of the chemical change permitted without compromising the integrity of the starch and consequently the integrity of the whole grain.

3.12 Figures 1 and 2 of the patent in suit do not disclose anything more than Table 1 as regards the hydrolysed product. Figure 1 provides the "% starch" of corn and wheat flour pre- and post-extrusion. No information on the method for the determination of these values is disclosed. Nor is it possible to determine the change in the starch which occurred during the hydrolysis. The same applies to Figure 2, which also merely provides the "% starch" of whole oat flour after extrusion or extrusion/hydrolysis. The board is not convinced by the appellant's argument that Figure 2 reflects acceptable margins for the starch degradation. The value 2sigma is a commonly used statistical value (2 standard deviation) which reflects the area in which almost all the values of a data set can be found. In the case at hand, this is the data set which led to the determination of the mean value (i.e. 53.66) of the starch content for the pre-processed whole oat flour. No conclusion as to the degree of depolymerisation or the nature of the starch molecules and therefore to any margin of starch degradation can be drawn from Figure 2.

3.13 Furthermore, as already explained in point 3.4 above, the patent in suit does not contain any information on the preparation of the products in Table 1 or Figures 1 and 2. The skilled person could not have reproduced and analysed them to obtain at least some guidance as to the degree of degradation permissible without jeopardising the integrity of the whole grain.

3.14 The board also agrees with the opposition division and the respondent that the information on the process parameters in step a) is scarce and those parameters specified are certainly not narrow as argued by the appellant. In this context, the board notes that according to the patent specification, a hydrolysis step takes place before the hydrolysed whole grain flour is transferred to the extruder in which the hydrolysis and breakdown of the whole grain flour continues (see claim 1 and paragraph [00014], first sentence). No information at all is provided regarding the process parameters of this pre-extrusion hydrolysis, e.g. the type of amylase, its concentration, the temperature and pressure of reaction mixture, etc., all of which significantly influence the outcome of the hydrolysis (see point 3.4 above). The appellant's argument that the pre-extrusion hydrolysis was not relevant is therefore not convincing. Moreover, the alleged insignificance is not derivable from the patent in suit.

3.15 According to paragraph [0014] of the patent, the hydrolysis continues in the extrusion step. Similar to the pre-extrusion hydrolysis, most of the process parameters in the extrusion step, such as type and concentration of amylase, temperature and pressure, are not disclosed. Paragraph [0014] states that the material in the extruder is heated from an initial inlet temperature to a final exit temperature. The allegedly narrow temperature range to which the appellant referred in this context is the temperature range for the enzyme destruction and at best refers to a temperature range for the exit temperature. The same applies to the pressure, which is the pressure at the exit of the extruder.

3.16 The board accepts that some information on the duration of the hydrolysis steps is derivable in the patent in suit (see paragraph [0015]). However, this information concerning a single parameter is not sufficient in a situation where the outcome of a reaction, in the case at hand, the hydrolysis before and during the extrusion, depends to a significant extent on a number of other parameters, which are not defined or are only insufficiently defined.

3.17 At the oral proceedings, document D27 was extensively discussed and relied on by both parties. According to the appellant, D27 showed that the selection of appropriate reaction conditions is a purely routine task if the skilled person knows what they want to achieve.

3.18 D27 is a datasheet for a commercially available alpha-amylase, namely "Validase BAA 1000L". The document explains, inter alia, the functionality, activity and usage of the enzyme and provides information on certain parameters that can influence the performance of the enzyme (amount, pH and temperature). According to D27, Validase BAA 1000L selectively and efficiently breaks down starch and starch fragments. It reduces their size, shape and chain length; breaks down interior alpha-1,4-glycosidic bonds; and liberates dextrins and oligosaccharides (see first page, left-hand column, second and third paragraph). It can be used to liquefy starch and readily hydrolyses starch into dextrins, maltose and glucose (see first page, right-hand column, third paragraph; second page, left-hand column, last paragraph). At a dose of 0.035 to 0.070% based on starch weight and under optimal processing conditions, it adequately liquefies a 30 to 35% starch slurry in 15 to 30 minutes (see first page, right-hand column, fifth paragraph). D27 also provides information as to the effective and optimum range of certain parameters such as pH and temperature (see first page, left-hand column, fifth paragraph; second page, sections regarding the effect of pH and temperature).

In sum, D27 provides important information regarding the use of Validase - a representative for alpha-amylase in general - in the liquefaction of starch, i.e. the degradation of starch into a spectrum of dextrins, oligosaccharides and maltose, the exact opposite of what the patent wants to achieve. The routine tests to which the appellant referred (see D27, first page, right-hand column, first paragraph) are tests to find the optimum conditions for the liquefaction, for which there is sufficient guidance in D27 (e.g. amount of enzyme, effective and optimal pH and temperature). However, no guidance is provided as to how to control the hydrolysis in such a way that the starch molecules are essentially maintained while at the same time the formation of low molecular molecules, such as dextrins and maltose, is avoided.

Moreover, the board is convinced that the routine selection of appropriate process parameters for the hydrolysis with the help of Validase or any other alpha-amylase is only possible if the desired product is clearly defined, for example, in terms of a permissible degree of breakdown or depolymerisation or any other clearly defined property that would have allowed the skilled person to conclude that the hydrolysis had not changed the starch to such a degree as to compromise its integrity and therefore the integrity of the whole grain. Precisely this information is missing in the patent in suit (see point 3.10 above).

3.19 For the aforementioned reasons, the board concludes that the patent in suit neither sufficiently defines the hydrolysed intermediate or final product nor clearly discloses at least one way of obtaining such a product. Contrary to the appellant's opinion, the lack of this information is not merely a clarity issue. Rather, it concerns the very essence of the invention, the preparation of a hydrolysed whole grain flour product in which the integrity of the whole grain is maintained.

3.20 The appellant also argued that the respondent had not discharged its burden of proof because it had not provided any experimental evidence to support its objection of lack of sufficiency of disclosure (i.e. it had not tried to carry out the invention).

3.21 The board agrees with the appellant that the burden of proof of insufficiency rests as a general rule with the opponent.

However, as explained in points 3.4 and 3.10 to 3.18 above, the patent in suit does not contain instructions (e.g. specific protocol or working example) which are sufficiently complete and detailed enough for the skilled person to rework the invention and to obtain the intended, functionally defined product. In these circumstances, it is sufficient for the opponent to raise serious doubts as to whether the skilled person can carry out the invention by showing that there are gaps in the disclosure which the skilled person cannot close using their common general knowledge. If a patent lacks a complete and detailed disclosure in relation to a functional feature, the opponent cannot be expected to compensate for the lack of information and to close existing gaps in an inventive manner.

In the case at hand, the board judges that the opponent has discharged its burden of proof. It was then up to the patent proprietor to rebut the opponent's argument and to explain why there are no gaps and why the information provided in the patent in suit in combination with common general knowledge is sufficient for the skilled person to carry out the invention and to obtain a whole grain flour, which maintains the integrity of the whole grain. For the reasons set out in points 3.8 to 3.19 above, the appellant's arguments in favour of sufficiency of disclosure do not convince the board.

3.22 Hence, the board concludes that the subject-matter of claim 1 of the main request does not comply with the requirement of sufficiency of disclosure. The main request is therefore not allowable for non-compliance with Article 83 EPC.

First to fifth auxiliary request

4. Sufficiency of disclosure

In claim 1 of each of the auxiliary requests, the hydrolysis step a) is identical to the hydrolysis step a) of the main request. Thus, the same observations and conclusion under Article 83 EPC apply mutatis mutandis to the subject-matter of claim 1 of the first to fifth auxiliary request. Therefore, these requests are not allowable either.