T 1689/10 (Retinoid-containing compositions/JOHNSON & JOHNSON) 11-07-2013

Reasons for the Decision

1. The appeal is admissible.

2. Inventive Step

Main request

2.1 The Board considers, in agreement with the Examining Division and the Appellant, that the closest prior art is the disclosure of document (3).

Document (3) discloses topical skin compositions (see claim 1) which may contain retinoids such as retinol (see paragraph [0055]). It teaches that retinoids tend to irritate the skin such that irritancy mitigants such as oat extract may be incorporated into the composition to assist in preventing undue discomfort to the user (see paragraph [0056]).

2.2 In view of this state of the art, the Appellant defined the problem underlying the present application as the provision of alternative compositions comprising retinol which counteract the skin irritation caused by said retinol.

2.3 As the solution to this problem, the main request proposes a composition as defined in claim 1, characterised in that it contains avenanthramide or an avenanthramide derivative.

2.4 Having regard to the test results given in Examples 1 to 4 of the present application, the Board is satisfied that the technical problem as defined in point 2.2 above has been successfully solved by the claimed compositions.

2.5 Finally, it remains to decide whether or not the proposed solution to the problem underlying the application is obvious in view of the state of the art.

2.5.1 When starting from a composition comprising retinol known from document (3), it is a matter of course that the person skilled in the art seeking to provide an alternative composition wherein the skin irritation known to be caused by the retinol is reduced, would turn his attention to that prior art addressing compounds for use in compositions which treat skin irritation, for example, document (7). Said document (see claims 10 to 14) teaches that an oat extract containing avenanthramide may be used for the preparation of a topical dermatological composition for treating inter alia inflammations and irritations affecting the skin. Document (7) thus gives a clear incentive on how to solve the problem underlying the application in suit of providing merely alternative compositions comprising retinol which counteract the skin irritation caused by the retinol, namely by incorporating avenanthramide into the retinol-containing compositions of document (3). Thus by combining the teachings of documents (3) and (7), the person skilled in the art would arrive at the subject-matter of claim 1 of the main request without exercising an inventive step.

2.6 For the following reasons, the Board is not convinced by the Appellant's submissions in support of the presence of an inventive step.

2.6.1 The Appellant argued that the compositions were inventive over document (3), since the focus of said document was on the mandatory ingredients of the compositions described therein, namely an anti-superoxide component, an anti-hydrogen peroxide and/or an anti-peroxyl radical component, and an anti-hydroxyl radical component. Retinoids such as retinol were merely one of many optional ingredients.

However, present claim 1 is not directed to compositions containing only retinol and avenanthramide or a derivative thereof, but rather to compositions comprising these ingredients, such they may contain any other additional components including, for example, the mandatory ingredients of document (3). Thus, the compositions of present claim 1 do not differ from those of document (3) in this respect and the Appellant's argument is thus not pertinent.

2.6.2 The Appellant further argued that document (7) taught that apart from avenanthramide, the carbohydrates and protein in oat derivatives also had beneficial effects on the skin, such that avenanthramide had to be chosen from other active ingredients disclosed in this document. Indeed, the combination of avenanthramide together with the treatment of skin irritation from the list of other skin ailments disclosed in document (7) and retinol from document (3) was only obvious with the benefit of hindsight.

However, the starting point for assessing inventive step is the composition containing retinol according to document (3) (see point 2.1 above). The fact that the skilled person had several alternatives at his disposition when looking for an alternative irritancy mitigant for incorporation into the retinol-containing compositions of document (3) has no impact on the assessment of inventive step, since a mere choice from a host of possible solutions does not in itself involve inventive ingenuity (see decision T 939/92, OJ EPO 1996, 309, points 2.5.2 and 2.5.3 of the reasons). Indeed there is in fact a specific motivation to choose avenanthramide from within document (7), since the claims of said document are directed specifically to compositions containing this active ingredient, carbohydrates and protein for soothing the skin being mentioned merely in the description of the background art (see page 2, lines 1 to 3).

2.6.3 Finally, the Appellant argued that it could be seen from Table 2 of the present application that a composition comprising avenanthramide was more effective in reducing interleukin-8 release than a composition comprising oat straw, such that the selection of this specific active ingredient from an oat extract provided an unexpected effect vis-à-vis the teaching of document (3).

However, according to established jurisprudence, in the case where comparative tests are chosen to demonstrate an inventive step with an improved effect, the nature of the comparison with the closest state of the art must be such that the effect is convincingly shown to have its origin in the feature differentiating the invention from this prior art (see T 197/86, OJ EPO 1989, 371, points 6.1.2 and 6.1.3 of the reasons).

In the present case, and as acknowledged by the Appellant at the oral proceedings before the Board, the amounts of the various active ingredients given in Table 2 for purposes of comparison are not the same. More particularly, the two test products according to the invention contain Dragocalm® "at concentrations of 1.5 wt.% and 3.5 wt.% (0.0001 to 0.00035 wt.% of active matter)" (see page 8, penultimate two lines), said active ingredient being avenanthramide (see page 4, lines 1 to 2), whereas the test product referred to by the Appellant for comparison contains oat straw at a concentration of 0.1 wt.% as well as willow herb at the same concentration. Thus, any effect shown may in fact be merely due to these differing amounts and not necessarily to the nature of the active ingredient. In addition, it has not been shown that oat straw does not itself contain avenanthramide. Thus no unexpected effect has been shown by the Appellant which might support the presence of an inventive step.

2.7 As a result, the Appellant's main request is not allowable as the subject-matter of claim 1 thereof lacks inventive step pursuant to Article 56 EPC.

Auxiliary requests I to V

3. Claim 1 according to the auxiliary requests I to V has been amended vis-à-vis claim 1 of the main request in that component (a), namely retinol, is specified as being present in an amount of 0.001 to 1 wt.-% (auxiliary request II) or 0.075 wt.-% (auxiliary request IV) and component (b), namely avenanthramide or a derivative thereof, is specified as being present in an amount of 0.0001 to 0.00035 weight-% (auxiliary request I, II, IV and V) or 0.0005 weight-% or less (auxiliary request III). The wording of claim 1 of auxiliary request V differs additionally from claim 1 of auxiliary request I in that component (a) is defined as being at least one retinoid.

3.1 No unexpected effect has been shown to be associated with the particular weight amounts of avenanthramide or a derivative thereof and of retinol specified in claim 1 of these auxiliary requests. The act of picking out at random a range or particular value for the amounts of avenanthramide or a derivative thereof and of retinol is within the routine activity of the skilled person faced with the mere problem of providing alternative compositions comprising retinol which counteract the skin irritation caused by the retinol. In the present case, the skilled person is all the more guided to pick out the amounts claimed, since topical skin compositions comprising retinoids in an amount of 0.01 to 5% by weight are preferred in document (3) (see paragraph [0057]) and compositions for treatment of skin comprising avenanthramide in a concentration of 0.01 to 150 ppm, which corresponds to 0.000001 to 0.0150 wt.-%, are described in document (7) (see claim 1). Therefore, the arbitrary choice of amounts falling under those already taught in the state of the art cannot provide the claimed composition with any inventive ingenuity. In addition, the replacement of the feature "retinol" by "at least one retinoid" in claim 1 of auxiliary request V cannot contribute to inventive step, since the generic term "retinoid" embraces the specific compound "retinol", such that all argumentation and conclusions of the Board herein regarding the inventiveness of compositions containing retinol apply equally to compositions containing retinoids.

3.2 The Appellant argued that the amounts of active ingredients specified in the auxiliary requests were those specific amounts which led to a high reduction in interleukin-8 production, as shown in the Examples of the application in suit, and were much narrower ranges and much smaller amounts than those disclosed in documents (3) and (7).

However, so long as no unexpected effect has been shown to be associated with the particular weight amounts claimed, they may only be regarded as arbitrary, the "high" reduction in interleukin-8 production shown in the Examples of the application in suit not having been compared with that obtained with amounts outside the claimed ranges.

3.3 Thus, the auxiliary requests I to V are also not allowable, since the subject-matter of claim 1 of each request lacks an inventive step pursuant to Article 56 EPC.