T 0767/12 - Non-therapeutic use

Key points

• In this examination appeal, independent claim 2 is direct to "Use of a composition comprising arachidonic acid ... for the non-therapeutic [...] promoting synchronisation of circadian rhythm". A circadian rhythm is a biological process displaying a 24 hour period. 
• The Board: " the disclaimer in claim 2 of the main request at hand also introduces a lack of clarity, since the methods of the invention are necessarily therapeutic and their exclusion renders the scope of claim 2 void. This conclusion derives from the fact that desynchronisation of circadian or infradian rhythm causes symptoms which are generally recognised as being pathology-related and which produce at best discomfort." 
• The Board: " Whether or not a symptom is of pathological nature cannot be established subjectively on the basis of the symptom intensity perceived by the patient. As the symptoms caused by biorhythm desynchronisation, such as sleep disorder, dizziness or headache, are generally recognised as being pathology-related, their treatment or prevention is necessarily therapeutic. The argument that the patient may be relieved from symptoms merely by resting cannot be accepted as a criterion for classifying a method as being non-therapeutic, since this is also a way of curing a cold, for instance, which is a clear pathological condition."
• The appeal was forwarded to the Board in March 2012 and there was simply no action until 15.06.2018 (summons).

EPO T 0767/12 -  link

VI. With a letter of 4 December 2018, the appellant filed a new main request and auxiliary requests 1 to 4 to replace the previous ones.

Independent claims 1 and 2 of the main request read as follows:

"1. Use of triglyceride comprising arachidonic acid as a part of or all of the constituting fatty acids, or of methyl arachidonate or ethyl arachidonate, as active ingredient in the manufacture of a composition having a normalising action for infradian rhythm and/or a synchronisation promoting action for circadian rhythm, the composition being for therapeutic prevention or alleviation of biorhythm disorder caused by abnormality of infradian rhythm, or by retardation of synchronisation of circadian rhythm.

2. Use of a composition comprising as active ingredient triglyceride comprising arachidonic acid as a part of or all of the constituting fatty acids, or of methyl arachidonate or ethyl arachidonate, for non-therapeutic normalising of infradian rhythm and/or promoting synchronisation of circadian rhythm."

Reasons for the Decision

1. The appeal is admissible.

2. Main request

The disclaimer "non-therapeutic" in claim 2 of the main request was not disclosed in the application as originally filed. Accordingly, its allowability has to be examined in the light of decision G 1/03 (see also G 1/16, Reasons, point 43).

On this issue, the examining division held that it was not possible to distinguish between the therapeutic and non-therapeutic methods of the invention and hence the condition set out in G 1/03, Headnote, item 2.4, that the disclaimer must meet the requirements of clarity and conciseness (Article 84 EPC), was not fulfilled.

In the board's view, the disclaimer in claim 2 of the main request at hand also introduces a lack of clarity, since the methods of the invention are necessarily therapeutic and their exclusion renders the scope of claim 2 void. This conclusion derives from the fact that desynchronisation of circadian or infradian rhythm causes symptoms which are generally recognised as being pathology-related and which produce at best discomfort.

On this issue, the appellant argued that when the symptoms caused by biorhythm desynchronisation merely represent a transient nuisance, such as a slight sleep disorder removable by having some rest, they do not reflect a pathological state and their treatment cannot be considered to be therapeutic.

The board disagrees. Whether or not a symptom is of pathological nature cannot be established subjectively on the basis of the symptom intensity perceived by the patient. As the symptoms caused by biorhythm desynchronisation, such as sleep disorder, dizziness or headache, are generally recognised as being pathology-related, their treatment or prevention is necessarily therapeutic. The argument that the patient may be relieved from symptoms merely by resting cannot be accepted as a criterion for classifying a method as being non-therapeutic, since this is also a way of curing a cold, for instance, which is a clear pathological condition.

In addition, the appellant compared the methods in claim 2 with the treatment of fatigue discussed in the decision T 469/94. In that case, the board acknowledged that reducing the perception of fatigue in a person being about to participate in a major exercise or having completed a major exercise was non-therapeutic for two reasons: i) it was a transitory physiological condition caused by natural circumstances and removable by simple rest, in contraposition to situations where the person is relieved from pain or discomfort (see Reasons, point 4.2); and ii) non-therapeutic and therapeutic treatments could be separated because they involved different groups of persons (see Reasons, point 4.4).

In the board's view, the present case differs from the situation underlying T 469/94 in both of those essential aspects. Firstly, the symptoms treated with the alleged non-therapeutic method are not caused by natural circumstances but rather by an artificial shifting of natural rhythm which puts the person in a situation of at least discomfort and which provokes symptoms that are identified with pathologies, e.g. sleep disorder, dizziness, headache. Secondly, in view of the finding that the symptoms caused by biorhythm desynchronisation are necessarily therapeutic (see point 2, fourth paragraph above), the question of whether or not a therapeutic application can be separated from a non-therapeutic use does not arise.

Similarly to the case of T 469/94, the situations underlying decisions T 144/83 and T 584/88 are not applicable to the present case because in T 144/83 and T 584/88 the board could effectively distinguish between two groups of subjects: those suffering from being slightly overweight and those suffering from obesity (T 144/83), and those suffering from unhealthy snoring and those suffering from disturbing snoring (T 584/88).

In consequence, the disclaimer in claim 2 does not meet the requirements of Article 84 EPC and is therefore unallowable under G 1/03 (see Headnote, point 2.4) and G 1/16 (see Reasons, point 43).

[...]

3. Auxiliary request 1

[claim 2 is deleted]

3.1 Inventive step

The application [claim 1] is directed to the use of triglycerides containing arachidonic acid, methyl arachidonate or ethyl arachidonate as active ingredients for preventing or alleviating biorhythm disorders caused by abnormality of infradian rhythm or by retardation of synchronisation of circadian rhythm.

[...]

3.1.7 In conclusion, none of the cited documents or their combinations suggests the use of an arachidonic acid triglyceride, methyl arachidonate or ethyl arachidonate for the normalisation of biorhythm disorders. Hence, the subject-matter claimed in the only independent claim of auxiliary request 1 is inventive.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The case is remitted to the examining division with the order to grant a patent with the following claims and a description to be adapted thereto:

claims 1 to 15 of auxiliary request 1 filed during the oral proceedings of 13 December 2018.