T 0576/19 20-12-2022

Reasons for the Decision

1. Admissibility of the appeal

The appeal complies with Articles 106 to 108 EPC and Rule 99 EPC; it is admissible.

2. Inventive step - main request

Patent in suit

2.1 As acknowledged in the patent in suit, rose hip formulations, including formulations prepared from rose hip shells as described in prior-art document D2, were known to alleviate symptoms associated with inflammation and arthritis (see paragraphs [0003] to [0009] of the patent specification). The patent in suit seeks to provide a process for preparing a composition comprising dried rose hip with anti-inflammatory properties that is improved in the concentration of active ingredients (see paragraphs [0001] and [0010] of the patent specification). This is expected to improve patient compliance, as the same amount of active ingredients can be administered in a lower volume of material, i.e. with fewer tablets or capsules.

2.2 The process defined in claim 1 as granted involves grinding dried and chopped rose hip shells and applying cooling during the grinding process so that the grinding is performed at a constant temperature below 40°C.

The drying and chopping may be performed in any order suitable (see paragraph [0050] of the patent specification).

Starting point in the prior art

2.3 It was common ground that document D2 (cited in the application as filed) represents the closest prior art.

2.4 Like the patent in suit, D2 discloses a process for the preparation of rose hip powder from dried rose hip shells (see D2: claim 20 and column 3, lines 18 to 44). The process according to claim 20 of D2 involves:

- obtaining a plurality of rose hips

- fracturing the rose hips into pieces

- separating the flesh portion of the rose hips from other matter

- drying the flesh portion of the rose hips at temperatures below 50°C to a water content of about 5%

- grinding the dried flesh portion of the rose hips to produce a powder

- providing the powder in a physiologically acceptable form.

It was not in dispute that the term "flesh portion" refers to the rose hip shell.

According to the description (D2: column 3, lines 18 to 44) the drying step may be carried out before the separation step.

2.5 With this process, a powder or granular material having a particle size of below 1 mm, preferably 0.1 to 0.5 mm, can be obtained (see D2: column 3, lines 42 to 43).

Distinguishing technical feature

2.6 Claim 1 as granted differs from the disclosure in D2 by the specification that cooling is applied so that the grinding of the rose hip shells is performed at a constant temperature below 40°C.

Objective technical problem and solution

2.7 The alleged technical effect of the claimed process in comparison with the process disclosed in D2 is that, because milder process conditions help avoid the degradation of active substances, a higher content of active substances in the ground rose hip shell material may be attained. Thus, the appellant based its reasoning in support of inventive step on an alleged improvement.

2.8 The board considers that the alleged technical effect has not been rendered credible, for the reasons set out below.

2.8.1 According to the jurisprudence of the EPO, the nature of the comparison with the closest prior art must be such that the alleged technical effect is convincingly shown to have its origin in the distinguishing technical feature (see, for instance, T 197/86, OJ 1989, 371). The alleged technical effect must also be credibly attainable over the whole of the claimed scope.

2.8.2 Contrary to the appellant's view, the association of the alleged technical effect with the distinguishing technical feature is a necessary requirement. If it were not known which technical features were responsible for the technical effect(s) observed in a comparative test, it would not be possible to infer that the claimed subject-matter indeed provides a specific technical effect in comparison with the closest prior art.

2.8.3 A comparison meeting the criteria:

(a) comparison with the closest prior art

(b) alleged technical effect linked to the distinguishing technical feature

(c) technical effect attainable across scope claimed

was provided neither in the patent in suit (or the corresponding passages of the application as filed) nor with the appellant's submissions.

2.8.4 In support of the alleged technical effect, the appellant relied, in one approach, on a comparison of statements about dosing found in the prior art and in the patent in suit. While the powder prepared according to D2 was to be administered in an amount of at least 20 g per day (as stated in D2, column 2, lines 41 to 42), the powder prepared according to the patent in suit could be administered in an amount of 4.5 g or even just 2.25 g per day (see Example 2 of the patent in suit).

However, comparing statements about dosing in D2 and in the patent in suit does not constitute a direct comparison between powders obtained from the same batch of raw material and with process conditions that only differ by applying, or not applying, the cooling defined in claim 1. This means that the difference in dosing cannot be conclusively attributed to the distinguishing technical feature (criterion (b)). Other parameters relating to raw materials, equipment and process conditions may have differed that could have affected the content of active substances in the rose hip shell powders on which the dosing recommendations were based.

2.8.5 The examples described in the patent in suit do not focus on the distinguishing technical feature and (as conceded by the appellant) do not provide a direct comparison of the claimed process with that of the closest prior art D2.

- Example 1 relates to two preparations that "were prepared according to the present invention and differed only by the type of rose hips used." The example has no comparative embodiment representing the closest prior art (criterion (a)).

- Example 2 relates to a clinical study in patients with osteoarthritis of the knee, in which rose hip powder according to the patent in suit was compared to a commercially available product of the prior art - in other words, a product manufactured from a different batch of raw material under unknown process conditions. For that reason alone, it cannot be acknowledged that Example 2 provides a correct comparison focused on effects linked to the distinguishing technical feature (criterion (b)).

Furthermore, contrary to the statement in paragraph [0076] of the patent in suit, it also appears that the comparative sample was not a powder according to D2. It was uncontested that document D1 relates to the same clinical study that is also the subject of Example 2 of the patent in suit. According to D1 (see the abstract and page 268, left column, second paragraph), the comparative product was manufactured from whole rose hips and included material from rose hip seeds. Thus, Example 2 does not provide a comparison with the closest prior art D2 (criterion (a)).

The appellant argued that, in light of the teaching of the prior art (e.g. in D3 or D5), rose hip powder containing seeds, such as the comparative sample in Example 2, would in any case have been expected to have a higher potency than rose hip powder prepared from shells only, and therefore this choice of comparative sample would not have influenced the outcome in favour of the "inventive" sample. However, this argument remains speculative, since nothing is known about the content of seed material in the comparative sample or about the qualitative and quantitative content of active components in either sample. The appellant's argument, in any case, does not overcome the objection relating to criterion (b).

- Examples 3 and 4 relate to samples of rose hip powder which were "manufactured by conventional processes" that are not defined in detail (Samples A and C), and samples "manufactured according to the process of the present invention", also not defined in detail (Samples B and D). All of the samples were manufactured from rose hips of the species Rosa canina, Rosa moschata and Rosa rubiginosa (see paragraph [0082]). It cannot be inferred from the information provided that all of the samples were produced from the same batch of rose hips or even from rose hips of the same species. Thus, it is unknown also in this case which parameters differed in the preparation of the four powder samples, and it would not be possible to conclude that any observed difference in the content of active ingredients had its origin in the distinguishing technical feature (criterion (b)).

The main difference between these samples was the content of triacylglycerols and fatty acids, highest in Samples A and C. This was attributed to the presence of seeds in Samples A and C (see paragraph [0097]). Hence, it is evident that the comparative samples do not represent the closest prior art D2 (criterion (a)).

2.8.6 The appellant's experiment described in Annex 1 does provide a comparison carried out with rose hip shell material from the same batch. A powder obtained by a process according to the patent in suit and a powder obtained by a comparative process were compared with respect to their effect on levels of the pro-inflammatory cytokine TNF-alpha in an in vitro cell culture experiment.

However, the comparative process in Annex 1 is not the process according to D2. Annex 1 states, instead, that rose hip shell powder prepared as described in the patent in suit, i.e. ground at a controlled temperature below 40°C, was split into two batches. One was not subjected to heat and one was subjected to 50°C for five minutes, in order to model heat exposure of the powder during grinding. Thus, rather than directly reproducing the prior-art process by grinding the rose hip shells in the same apparatus without cooling, the appellant made an assumption about heat exposure in the prior-art process and then implemented a process step involving heat exposure subsequent to grinding, to model this assumption.

No technical basis is given for the assumption regarding heat exposure, which must, therefore, be regarded as speculative. There is no evidence that without cooling, the heat exposure of the material during the grinding step might indeed be equivalent to five minutes' exposure to 50°C, in any mill that could have been used to implement the grinding step required in D2:

- The appellant's Annex 1 does not describe the apparatus and process parameters used for the grinding step, apart from stating that grinding was carried out at a controlled temperature below 40°C. The time required for grinding is not mentioned.

- In document D13 (Experiment 2), the respondent reports that "less than a few seconds" were required for grinding the rose hip shell material under specified process conditions, and the temperature of the powder immediately upon leaving the mill was 30°C.

In conclusion, it cannot be confirmed on the basis of the available information that the comparison in Annex 1 adequately represents a comparison with the closest prior art D2 (criterion (a)).

Moreover, the experiment described in Annex 1 cannot render the attainment of the alleged technical effect credible across the temperature range claimed (criterion (c)), since the document does not reveal the temperature at which the material was maintained during the grinding step. It could have been close to the upper limit of 40°C but it could also have been much lower (preferred temperatures according to claim 1 are "below 20°C"). If the milling temperature in the experiment had been, for instance, 10°C, the same result (in terms of the efficacy of the "inventive" sample) could not necessarily be expected with a milling temperature of 39°C, which is still within the scope claimed.

For these reasons, the results reported in Annex 1 do not show conclusively that the alleged technical effect is linked to the distinguishing technical feature and is attained over the whole scope claimed.

2.9 As the alleged technical effect was not rendered credible, it cannot be taken into account in the formulation of the objective technical problem.

2.10 Thus, the objective technical problem is to provide an alternative process for preparing a dry powder from rose hip shells.

2.11 It was not in dispute that the process defined in claim 1 as granted solves this problem.

Obviousness of the solution

2.12 Seeking to solve the objective technical problem, the person skilled in the art would routinely have considered modifying the process conditions, in particular with the intention of ensuring mild process conditions.

2.13 Plant materials typically contain components which are sensitive to heat and susceptible to thermal degradation. Rose hip is a plant material known to contain such components, such as vitamin C and other vitamins. The presence of vitamin C in food and drug products has, moreover, been known to be advantageous as a nutrient and as a pharmaceutically acceptable antioxidant and stabiliser. While vitamins may not be the active ingredients that bring about the composition's anti-inflammatory effect, their presence may still be desirable. Furthermore, it cannot be ruled out that other relevant rose hip components may be susceptible to thermal degradation.

2.14 D2 recommends drying the rose hip shells at temperatures below 50°C in order to preserve their vitamin content, since above that temperature notable deterioration in vitamin content is possible (see D2: column 3, lines 29 to 37). In a similar context, D5 (see page 303, right-hand column) describes a process for drying material from both shells and seeds, wherein the temperature never exceeds 40°C.

2.15 Hence, it was clear that gentle process conditions were desirable for processing the rose hip material. The person skilled in the art would furthermore have been aware that grinding requires the input of mechanical energy and generates heat. The grinding step might, therefore, expose the material to thermal stress.

2.16 It would thus have been an obvious precautionary measure to implement cooling as defined in claim 1 during the grinding step, in order to ensure gentle process conditions and protect any heat-sensitive components.

2.17 This would have been enough of an incentive, in the absence of a technical prejudice against doing so.

2.17.1 The appellant argued that the prior art only restricted the drying temperature and did not mention grinding as problematic. Still according to the appellant, as drying takes much longer than grinding, the person skilled in the art would not have been concerned about heat exposure during the comparatively short time the material spent in the grinder.

2.17.2 This argument is not necessarily correct, as it considers only the length of time and not the potentially heightened energy input mentioned in point 2.15. In any case, such general speculations do not amount to evidence of a technical prejudice which would have prevented the skilled person from implementing the process modification in question as an obvious precaution.

2.18 For these reasons, the subject-matter of claim 1 as granted does not involve an inventive step within the meaning of Article 56 EPC.

3. Inventive step - auxiliary request 1

3.1 Claim 1 of auxiliary request 1 differs from claim 1 of the main request solely in the requirement that the cooling applied is air cooling.

3.2 Air cooling is a common mode of cooling. This technical feature has not been associated with any particular technical effect or advantage, and accordingly it does not change the objective technical problem or the board's conclusion on obviousness.

3.3 As a consequence, the subject-matter of claim 1 of auxiliary request 1 does not involve an inventive step within the meaning of Article 56 EPC, for the same reasons as set out above with respect to claim 1 of the main request.

4. Inventive step - auxiliary requests 2 and 3

4.1 Claim 1 of auxiliary request 2 differs from claim 1 of the main request, and claim 1 of auxiliary request 3 differs from claim 1 of auxiliary request 1, by the additional process step of mixing the ground powder with 30 mg to 80 mg vitamin C per g rose hip powder. It is not specified what the content of vitamin C should be in the final product.

4.2 The technical effect achieved is that of increasing the content of vitamin C in the ground rose hip shell powder.

4.2.1 No direct comparison with the process and powder according to D2 was provided.

4.2.2 D2 describes its rose hip shell powder as containing a high content of vitamin C, especially when drying was conducted at temperatures below 50°C (see D2: claims 1 and 20; column 3, lines 29 to 37; Table 1). A typical content mentioned in D2 is 560 mg vitamin C per 100 g powder, i.e. 5.6 mg/g.

4.2.3 Thus, it would appear that the process according to auxiliary requests 2 and 3 involves adding relatively high amounts of vitamin C to the ground powder.

4.3 As pointed out by the appellant, the patent in suit, in paragraphs [0018] to [0020], makes the following statements in relation to added vitamin C:

(1) The presence of vitamin C is believed to facilitate the uptake in a subject of the active ingredients of the rose hip complex.

(2) The added vitamin C is also believed to provide for improved stability of the composition, thus improving the shelf life of the product.

(3) In a preferred embodiment, the added vitamin C is a synthetic vitamin as naturally occurring vitamin C in rose hip has shown to degrade too fast. In other words, added vitamin C compensates for vitamin C that was lost in processing the rose hip shells.

4.4 Thus, it has to be determined whether any of these effects attributed to added vitamin C constitutes a reason to modify the objective technical problem, or to formulate an additional technical problem to be solved.

4.5 As to the first effect, no evidence was provided to show that added vitamin C indeed facilitates the uptake of the relevant active ingredients (and ultimately improves the therapeutic efficacy of the powder).

4.6 As to the second effect, the appellant did not provide any evidence in comparison with the closest prior art regarding the effect of added vitamin C on shelf life.

4.7 In connection with the third point, the appellant did not provide any evidence regarding the degradation of vitamin C and whether this occurred faster in the claimed process than in the process according to D2. On the basis of the available information, it is not possible to say under which conditions, and to what extent, it would be necessary to compensate for loss of vitamin C during processing.

4.8 As alleged but unsupported advantages cannot be taken into consideration when determining the objective technical problem, the objective technical problem remains the same as for claim 1 of the main request, namely to provide an alternative process for preparing a dry powder from rose hip shells.

4.9 As an additional observation, the alleged technical effect of vitamin C acting as a stabiliser (see point 4.5 above), if acknowledged, would be plausible owing to the commonly-known properties of vitamin C, but for the same reason it would also not have been surprising and therefore could not contribute to inventive step.

4.10 With regard to the technical feature of temperature control during the grinding step, the same reasoning regarding obviousness applies as set out for claim 1 of the main request.

4.11 With regard to the process step of adding vitamin C to the ground powder, the following considerations are relevant:

4.11.1 As set out in section 2.13 above, the person skilled in the art would have been aware that vitamin C, a natural component of rose hips, had desirable properties as a nutrient and antioxidant/stabiliser, and that it was susceptible to degradation. Accordingly, it would have been logical to attribute some relevance to vitamin C content. In this context, it would have been a routine measure to check the vitamin C content of the processed material and to adjust as needed to the content desired in the final product (as argued by the appellant itself in a different context, see section XIV. above, on page 8, second paragraph). If indeed the degradation of the vitamin were unusually fast in the claimed process, this would have been detected and compensated for in the course of the routine activity of the skilled person.

4.12 For these reasons, the subject-matter of claim 1 of auxiliary requests 1 to 3 does not involve an inventive step within the meaning of Article 56 EPC.

5. Inventive step - auxiliary requests 5 to 8

5.1 Document D2 discloses a range of 0.1 to 0.5 mm, i.e. 100 to 500 mym, as the preferred particle size (see section 2.5 above).

5.2 Hence, the requirement in claim 1 of auxiliary requests 5 to 8 that the particle size of the ground rose hip shells must not exceed 550 mym is not a distinguishing technical feature relative to the disclosure of D2 and cannot contribute to inventive step.

5.3 With regard to the assessment of inventive step, the same reasoning and conclusions apply to auxiliary requests 5 to 8 as set out above for the main request and auxiliary requests 1 to 3.

5.4 The argument that more heat will be generated when milling to a smaller particle size does not overcome the objection that the alleged technical effect has not been rendered credible for any particle size. As set out in detail in section 2.8 above, no conclusive evidence was provided that the claimed process results in a different product on account of cooling the material to a temperature below 40°C during the grinding step. In addition, since the particle size is not mentioned in the examples of the patent in suit or in Annex 1, it cannot be confirmed that any of the samples tested was in conformity with the claims of auxiliary requests 5 to 8.

5.5 For these reasons, the subject-matter of claim 1 of auxiliary requests 5 to 8 does not involve an inventive step within the meaning of Article 56 EPC.