T 0292/17 (Whey-leucine composition/NUTRICIA) 07-06-2022

1. The appeal is admissible. It meets the requirements of Articles 106 to 108 and Rule 99(2) EPC.

2. The party as of right did not attend the oral proceedings before the board, as announced with its letter dated 20 May 2022. In view of this and in accordance with Rule 115(2) EPC and Article 15(3) RPBA, the board decided to continue the proceedings in the absence of this party.

The party as of right had not filed any submissions or requests in writing during the appeal proceedings although it had had ample opportunity to do so.

Therefore, the board was in a position to announce a decision at the conclusion of the oral proceedings, in accordance with Article 113(1) EPC and Article 15(6) RPBA 2020.

3. Admittance of new novelty objection and documents D37 and D38

3.1 In the statement of grounds of appeal, the appellant contested the novelty of the subject-matter of claim 1 as granted in light of example 3 of D1a. Subsequently, by letter dated 25 October 2018 (point 1.1.1), it introduced a new novelty objection based on the product MegaWhey**(TM) disclosed in paragraph [0007] of D1a. The admittance of this new objection is to be assessed under Article 13(1) RPBA 2020 (see also Articles 24 and 25 RPBA 2020), which establishes that any amendment to a party's appeal case after it has filed its grounds of appeal or reply is subject to the party's justification for the amendment and may be admitted only at the discretion of the board.

In its preliminary opinion (point 13.1), the board noted that the new objection was substantiated by a long discussion which included calculations and the consideration of additional prior-art documents. It also noted that the appellant had not provided the justification required by Article 13(1) RPBA 2020. Therefore, the board was minded to not admit the objection.

At the oral proceedings before the board, the appellant did not wish to make any further comment on the admittance of the objection. Therefore, there was no justification for admitting the objection, which added complexity to the case at an advanced stage of the proceedings to the detriment of procedural economy. Thus, the board decided not to admit the objection into the proceedings pursuant to Article 13(1) RPBA 2020.

3.2 In addition, the board decided not to admit documents D37 and D38 either. These documents were filed with the statement of grounds of appeal to support the appellant's inventive step arguments. In view of the board's conclusions on inventive step and the outcome of the appeal proceedings, the decision not to admit documents D37 and D38 into the proceedings pursuant to Article 12(4) RPBA 2007 needs no further reasoning.

4. Inventive step - claim 1 of the main request (patent as granted)

4.1 The patent (paragraph [0001]) concerns low-caloric high-protein nutritional compositions suitable for stimulating muscle protein synthesis in a mammal. The proteinaceous material of the nutritional compositions consists essentially of whey and some free leucine. The patent explains (paragraphs [0003] to [0005]) that the principle underlying the invention is the prior knowledge that muscle protein synthesis is stimulated by high blood levels of essential amino acids, especially leucine, and that whey protein contains higher level of leucine than casein protein. Via the clinical study disclosed in the patent, the inventors found that a nutritional composition as defined in claim 1 produces high serum concentration peaks of leucine and essential amino acids. Therefore, the nutritional composition of the invention is believed to be suitable for promoting muscle protein synthesis and preventing or treating diseases and conditions which involve muscle decline.

4.2 Document D1a (paragraph [0001]) is directed to the preparation of compositions for inducing the generation of muscle tissue. Like the patent, D1a (paragraph [0020]) relies on the principle that the availability to muscle cells of high amounts of essential amino acids and leucine stimulates the synthesis of muscle proteins. Preferably, the proteinaceous material in the compositions is mainly composed of whey and leucine (paragraph [0028] and examples). Although D1a focuses on inducing muscle protein synthesis in healthy subjects (paragraph [0005]), it also contemplates the use of its compositions for preventing loss of large amounts of muscular mass in patients recovering from surgery, who are often restricted in their food intake (paragraph [0032]).

4.3 The similarity of the compositions of D1a with those in the patent and their use for inducing muscle protein synthesis make D1a a suitable starting point for the assessment of inventive step. The appellant started from the powder in Example 2 of D1a, which contains 22.0 g whey protein concentrate and 4.4 g leucine. The board agrees that this is a suitable starting point.

The respondent contended that the starting point should be Example 6 of D1a because its composition was closer to the invention than that of Example 2. However, in accordance with the established case law of the boards, when two or more pieces of prior art may reasonably be used as the starting point for the assessment of inventive step, a conclusion that the subject-matter claimed is inventive can only be reached after assessing this requirement starting from all the possible closest prior art. Therefore, the respondent cannot argue against assessing inventive step starting from Example 2 of D1a.

The respondent also argued that Example 2 of D1a was not a suitable starting point because its composition was not disclosed for direct consumption. Rather than a final product, the composition in Example 2 was an intermediate to be admixed with further components to produce a product such as the food bar in Example 6. This argument is not convincing. As noted by the appellant, all the examples in D1a illustrate its invention. There is no basis in D1a to derive that some examples disclose intermediate products rather than final products. Therefore, the powder in Example 2 is a composition for promoting muscle protein synthesis according to D1a.

4.4 The respondent identified four distinguishing features between the composition of claim 1 and the one in Example 2 of D1a:

(i) at least about 80 wt.% of the proteinaceous matter in the composition is whey protein

(ii) the composition contains fat and digestible carbohydrates

(iii) it is used for the prevention or treatment of a disease or condition involving muscle decline

(iv) it is administered as one to two servings daily, each serving comprising between 80 and 200 kcal

4.4.1 It was common ground that feature (i) was indeed a distinguishing feature. Claim 1 requires that at least about 80 wt.% of the proteinaceous material be whey protein, with "about" meaning a deviation of up to 5% of that value. The parties agreed that this meant that the content of whey in the proteinaceous material of claim 1 was at least 76 wt.%.

The powder in Example 2 of D1a contains 22.0 g whey protein concentrate (WPC), which provides 17.6 g whey protein and 4.4 g leucine. According to the parties' calculations, this gave an amount of whey of approximately 70 wt.% of the proteinaceous material (statement of grounds of appeal, point 8.2.1.1; reply to the statement of grounds of appeal, page 21, last paragraph). So the proteinaceous material of the nutritional composition of claim 1 has a higher proportion of whey.

4.4.2 Regarding feature (ii), the board agrees with the appellant (statement of grounds of appeal, point 8.2.1.1.) that it is not a distinguishing feature.

The powder in Example 2 of D1a was prepared from 22.0 g of a WPC, which provided 17.6 g whey protein. This means that 80 wt.% of the WPC was whey and the remaining 20 wt.% was made of other components.

D2 is a handbook on dairy ingredients which represents common general knowledge on the priority date of the patent. This was not disputed. According to D2 (page 43), a WPC is a final dry product containing at least 25% protein. It is obtained by removing lactose, minerals and other materials from milk by ultrafiltration. Thus, the more concentrated the WPC, the lower the content of materials other than whey. The typical composition of WPC is the following (D2, page 43, upper table and page 44, right-hand column):

FORMULA/TABLE/GRAPHIC

It is apparent from this table that increasing the protein content of the WPC from 33 to 77% reduces the lactose from 52 to 9% while fat remains at 4 to 6%. D2 also refers (pages 45 and 46) to whey protein isolates, which are highly purified WPCs. They contain typically 89 to 93% protein, 2 to 3% lactose and 1% fat. Thus, a WPC having a protein concentration as high as 90% still contains some fat and lactose. Therefore, the board concludes that the only technically sensible interpretation of Example 2 of D1a is that its WPC, which contains 80 wt.% whey, also contains some amounts of fat and lactose. Therefore, the respondent's interpretation that the powder in Example 2 does not contain any fat and digestible carbohydrate (e.g. lactose) has to be rejected.

4.4.3 As to feature (iii), even though D1a mentions the possibility of using its compositions for preventing muscle decline in patients undergoing surgery, the main focus of D1a is on non-therapeutic indications (see point 4.2 above). Example 2 is not disclosed in connection with any purpose, let alone with the aim of treating a disease or condition involving muscle decline. Accordingly, the board agrees with the respondent that feature (iii) is a distinguishing feature.

4.4.4 Similarly, there is no disclosure in D1a that the composition of Example 2 is administered to a subject in one to two servings of 80 to 200 kcal each. So feature (iv) is also a distinguishing feature.

4.5 In view of the above, the board concludes that the features distinguishing the subject-matter of claim 1 from Example 2 of D1a are (i), (iii) and (iv).

4.6 The next step in the problem and solution approach is to establish the effect that these distinguishing features bring about. For this, the respondent referred to the clinical study in the patent (paragraph [0080]). This study shows the serum levels of amino acids, essential amino acids and leucine produced by four nutritional compositions, namely a high whey-protein, low-caloric composition according to claim 1 ("Active"); a high casein-protein, low-caloric composition (Control 1); a high casein-protein, high-caloric composition (Control 2) and a high whey-protein, high-caloric composition (Control 3). According to the respondent, a comparison of the serum amino acid concentrations produced by Active and Control 3 demonstrated that reducing the caloric content of a high whey-protein composition has an advantageous effect. This proved that the composition of claim 1 was more suitable for inducing muscle protein synthesis than that in Example 2 of D1a.

The board disagrees. The powder in Example 2 of D1a is not a high-caloric composition. On the contrary, it contains only small amounts of fat and digestible carbohydrates, and, like the composition in claim 1, it is a high whey-protein, low-caloric composition. Therefore, a comparison of the effects brought about by the compositions Active and Control 3 does not allow drawing any conclusion on the powder in Example 2 of D1a. A comparison with Control 1 or Control 2 would not be suitable to show any effect either since they are based on a different protein. Consequently, the clinical tests in the patent do not show any advantageous effect of the composition of claim 1 over the powder in Example 2 of D1a. The technical effect of the distinguishing features is merely that a composition is provided for the treatment or prevention of the specified diseases.

4.7 Therefore, the objective technical problem has to be formulated as the provision of a composition for preventing or treating a disease or condition involving muscle decline in a mammal.

4.8 The board is satisfied that the solution proposed in claim 1 solves this problem. The clinical study in the patent demonstrates that a composition according to claim 1 (Active) produces high serum concentrations of leucine and essential amino acids. The common general knowledge referred to in the patent (paragraphs [0003] to [0005]) that high serum levels of essential amino acids, especially leucine, induce muscle protein synthesis, has not been contested. Therefore, the evidence in the patent makes it credible that the nutritional composition of claim 1 is suitable for promoting muscle protein synthesis and that it can be used for preventing or treating diseases and conditions which involve muscle decline.

4.9 However, for the following reasons, the solution proposed in claim 1 was obvious.

4.9.1 D1a teaches (paragraph [0028]) that the proteinaceous matter in a formulation according to its invention comprises preferably more than 90 wt.% of intact proteins or peptides, whey being the most preferred protein source. Hence, there is a clear motivation in D1a for the skilled person to increase the whey content of the composition of Example 2 beyond 80 wt.% of the proteinaceous material to provide an alternative composition that promotes muscle protein synthesis. So feature (i) does not contribute to inventive step.

4.9.2 As to feature (iii), the compositions of D1a produce high serum levels of essential amino acids and leucine (see point 4.2). Like the patent, D1a relies on the common general knowledge that high serum levels of essential amino acids and leucine stimulate muscle protein synthesis. Although D1a focuses on the promotion of muscle protein synthesis for aesthetic purposes, in paragraph [0032] it suggests the use of its compositions for preventing an important loss of muscular mass in patients recovering from surgery, who are often restricted in their food intake. Therefore, it was obvious to the skilled person that the compositions of D1a are also suitable for preventing or treating diseases or conditions involving muscle decline.

4.9.3 Regarding feature (iv), D1a suggests (paragraphs [0018] and [0021]) serving doses of 25 g, which is essentially the weight of the composition disclosed in Example 2. The appellant calculated the caloric content of such a serving dose, which resulted to be slightly above 100 kcal (statement of grounds of appeal, point 8.2.1.1 and letter of 27 April 2022). This calculation was not contested by the respondent. Thus, D1a suggests serving doses as defined in claim 1. In addition, a serving frequency of once or twice daily appears to be customary in the field of nutritional compositions and there is no evidence on file that it is associated with any technical effect. Accordingly, feature (iv) cannot contribute to inventive step either.

4.9.4 The respondent argued that the skilled person had no motivation to combine all the distinguishing features. Therefore, they would not have arrived at the subject-matter of claim 1.

This argument cannot succeed. In a case such as this in which the distinguishing features do not interact with each other to produce a combined or synergistic effect but merely constitute a juxtaposition of independent modifications of the starting point, there is no need to find a motivation for combining all the distinguishing features; a motivation to arrive at each of these features independently when intending to solve the problem posed suffices. The board has explained that the skilled person would have considered the composition in Example 2 of D1a suitable for preventing or treating diseases involving muscle decline. It has also explained that a composition containing higher amounts of whey was not only a feasible but even a preferable alternative; that the composition had a preferred serving size of 25 g, which amounts to approximately 100 kcal; and that administration once or twice daily was a customary measure for nutritional compositions. Therefore, the board holds that the skilled person would have arrived at the subject-matter of claim 1 in an obvious manner.

4.10 Consequently, the subject-matter of claim 1 does not involve an inventive step (Article 56 EPC), and the ground for opposition of Article 100(a) EPC prejudices the maintenance of the patent as granted.

5. Inventive step - claim 1 of auxiliary request I

Compared to claim 1 as granted, claim 1 of auxiliary request I additionally requires that the composition contains fats and carbohydrates in such an amount that their sum provides 10 to 60% of the total energy of the composition. At the oral proceedings before the board, the parties agreed that this limitation constituted an additional difference: the contribution of fats and carbohydrates to the total energy of the powder in Example 2 of D1a was below 10%. The respondent submitted that this difference produces an increase in the production of muscle protein. However, there is no evidence on file supporting such an allegation. Therefore, the objective technical problem to be solved remains the same as for the main request.

On obviousness, the respondent argued that the subject-matter of claim 1 was now inventive because the skilled person had no reason to add fats or carbohydrates to the composition of Example 2 up to the claimed level and at the same time maintain the ranges of the other features of the claim, since this would increase the serving size. However, the board agrees with the appellant that this feature is just an arbitrary modification that cannot render the claimed subject-matter inventive. The addition of fats and carbohydrates to a certain extent without modifying the amount of other ingredients falls within the obvious modifications the skilled person would carry out to the teaching of D1a. Therefore, the subject-matter of claim 1 of auxiliary request I does not involve an inventive step, contrary to Article 56 EPC.

6. Inventive step - claim 1 of auxiliary request II

This claim is identical to claim 1 as granted. Therefore, for the reasons put forward for the main request, the subject-matter of claim 1 of auxiliary request II does not involve an inventive step either (Article 56 EPC).

7. Inventive step - claim 1 of auxiliary request III

Claim 1 of auxiliary request III differs from claim 1 as granted in that it specifies that the nutritional composition is liquid. Apart from the obvious differences in properties between a powder and a liquid composition, the limitation to liquid compositions does not provide any effect over the powder in Example 2 of D1a. Therefore, the objective technical problem to be solved remains the same as for the main request.

D1a suggests in paragraph [0030] that its compositions may have the form of a beverage, a powder, a pudding-like product, a snack or a bar. Formulating the composition as a liquid (beverage) was merely one of the obvious alternatives proposed by D1a. The appellant's argument that the powder of Example 2 would not be expected to exert its technical effect if it were administered in liquid form is once again an unsupported allegation. Therefore, the subject-matter of claim 1 of auxiliary request III does not involve an inventive step (Article 56 EPC).

8. Inventive step - claim 1 of auxiliary request IV

This claim is identical to claim 1 of auxiliary request III. Therefore, for the reasons put forward for the latter, the subject-matter of claim 1 of auxiliary request IV does not involve an inventive step (Article 56 EPC).

9. Inventive step - claim 1 of auxiliary requests VI and VII

This claim is identical to claim 1 of auxiliary request I. Therefore, for the reasons put forward for auxiliary request I, the subject-matter of claim 1 of auxiliary requests VI and VII does not involve and inventive step (Article 56 EPC).

10. Admittance of auxiliary requests VIII to XIV

10.1 Auxiliary requests VIII to XIV were filed by the respondent after its reply to the statement of grounds of appeal. Therefore, their admittance is to be assessed under Article 13(1) RPBA 2020 (see also Articles 24 and 25 RPBA 2020).

10.2 For auxiliary requests VIII to X, the respondent submitted (letter dated 6 November 2018, page 14, lines 20 to 22) that they had been filed "in view of the objections to AR III and AR IV, which are directed to liquid compositions". This vague statement cannot qualify as the justification required by Article 13(1) RPBA 2020 on why the requests should be admitted.

At oral proceedings, the board gave the respondent the opportunity to comment on the admittance of these requests. However, the respondent declined making any further submissions on this matter.

10.3 With regard to auxiliary requests XI to XIV, the board noted in its preliminary opinion (point 16) that the respondent had filed them to overcome the novelty objection based on the product MegaWhey**(TM), filed by the appellant in its letter of 25 October 2018 (respondent's letters of 4 March 2019, page 16, lines 8 to 10 and 5 December 2019, page 19, lines 16 to 25, page 21, lines 3 to 6 and page 22, lines 9 to 18). Therefore, the admittance of auxiliary requests XI to XIV was bound to the admittance of this new objection.

At oral proceedings, the board decided not to admit the objection into the proceedings. Furthermore, inventive step was discussed only for the subject-matter involving therapeutic uses, i.e. the new interpretation of claim 1 was not taken into account either. Therefore, the board saw no reason for admitting auxiliary requests XI to XIV. Moreover, at the oral proceedings, the respondent declined the board's invitation to comment on the admittance of auxiliary requests XI to XIV.

10.4 Consequently, the board did not admit any of auxiliary requests VIII to XIV into the appeal proceedings (Article 13(1) RPBA 2020).