The patent relates to a feed composition for fish, comprising n-3 fatty acids, for use in the treatment and prevention of some diseases indicated in the claim.
Brief outline of the case
The opponent appealed the rejection of his opposition.
The OD considered that the disclosure was sufficient and the claim drafted as second medical use claim under Art 54(5) was novel and inventive over the available prior art.
The board also considered the disclosure sufficient as it was plausible that the claimed feed composition was suitable for treating the diseases indicated in the claim.
The opponent argued that the claimed subject-matter lacked novelty over the alleged public prior oral disclosure by Mr A Marthinussen during the MonAqua conference held on 2 November 2005, i.e. before the priority date.
The board held that the documents submitted to support the allegation did not provide convincing evidence that the claimed subject-matter was directly and unambiguously disclosed during the conference.
The opponent argued further that the subject-matter lacks novelty over an alleged instance of public prior use substantiated by several documents.
The board held that these documents did not provide convincing evidence that the claimed subject-matter was directly and unambiguously disclosed before the relevant date, regardless of the standard of proof applied.
The opponent argued lack of inventive step on the basis of a first PhD dissertation (D1, D2) supported by written evidence, some of it being late filed. The late filed proof was not admitted under Art 12(4) RPBA07 as it should have been filed earlier.
For the board, it could not be established whether the technical content of D1 (abstract) and D2 (dissertation as such) were made available to the public before the expiry of the embargo period, i.e. before 15 December 2013. Thus, neither D1 nor D2 were part of the state of the art.
The board concluded that the subject-matter of claim 1 as granted, as well as that of the following claims, which is narrower in scope, involves an inventive step over a second PhD dissertation (D5) taken as CPA.
The board thus confirmed the rejection of the opposition.
The alleged lack of inventive step
Definition of the CPA
D5 is a thesis of Mr Gerrit Timmerhaus, available in printed form from 13.03.2012.
D5 describes a study “aimed at increasing the general knowledge” regarding host-virus responses in Atlantic salmon, in particular responses to the virus causing cardiomyopathy syndrome (CMS). Piscine myocarditis virus (PMCV) is considered the most likely causative agent of CMS.
D5 is considered to provide a comprehensive picture of the state of the art in the relevant field. Since it was published on 13 March 2012, a few months before the priority date of the patent.
D5 represents the common general knowledge in the field on the date of priority. D5 was thus considered as CPA.
The opponent’s argumentation
The opponent submitted that the use of the claimed composition for treating CMS was obvious over a combination of D5 with D3=WO2011/031166 and D9=B.B. Jensen et al., “Diseases of aquatic organisms”, 2013, vol. 107, pp. 141-150.
The opponent selected D5 as the closest prior art as it was the “most promising springboard” towards the claimed invention.
The opponent considered that the subject-matter of claim 1 differed from that of D5 in that it related to a feed composition for fish in which more than 20% of the total fatty acids were n-3 fatty acids.
The opponent also submitted that the opposed patent at best provided evidence that the claimed composition reduced the symptoms of CMS, specifically inflammation of the atrium and the ventricle. Thus, the problem to solve was “the provision of a food composition for fish which reduces inflammation in the atrium and the ventricle”.
Its solution, namely the use of the claimed feed composition, was obvious in view of D3, which disclosed the beneficial effects of the same composition on heart and liver inflammation in fish affected by HSMI, a viral infection related to CMS.
The opponent mentioned decision T 1028/05. This decision related to a patent claiming the treatment of chronic obstructive pulmonary disease (COPD) with a combination of formoterol, a bronchodilator and budesonide, a steroid. This treatment was considered to lack an IS over a document disclosing the same drug combination for treating asthma, a respiratory disease related to COPD. According to the opponent, analogous conclusions should be drawn in the present case.
The board’s position
The board agreed that D5 was the CPA and that the difference was indeed that the feed contained more than 20% of the total fatty acids in form of n-3 fatty acids.
However, for the board, it cannot be overlooked that, while thoroughly describing the aetiology and pathophysiology of CMS, D5 is very speculative when discussing the possible therapeutic options for preventing and treating CMS.
In order to treat CMS, D5 mentioned vaccines or different feeding strategies and specific feed composition for treating viral diseases. The board noted that PMCV and diseases caused by it, e.g. CMS, are not even mentioned.
For the board D5 does not disclose any specific nutritional composition for treating CMS caused by PMCV either. It merely speculates on the possibility of conducting further studies aimed at the development of new strategies for controlling PMCV outbreaks.
The board concluded that the objective technical problem has to be formulated as the provision of a therapy for treating and preventing diseases caused by PMCV, in particular CMS and liver steatosis.
D5 shows that no therapy was known for treating and preventing diseases caused by PMCV in fish at the time of priority. Furthermore, it shows that the field of clinical nutrition of salmon was still in its infancy and that the therapeutic utility of feed compositions for fish could only be speculated upon. This means that at the time of priority the skilled person could, at most, have had a tenuous hope that a fish feed composition for treating the claimed diseases would be developed in the future.
For these reasons, the skilled person starting from D5 would barely have considered the teaching of D3. Even if they had, they would not have considered the idea of using the composition of D3 to treat and prevent diseases caused by PMCV, in particular CMS, to have a reasonable expectation of success. Therefore, they would not have endeavoured to test the utility of this composition for these therapeutic uses.
For the board, the alleged springboard represented by D5 was too short to allow the skilled person to reach out to D3 and to overcome the considerable gap separating the closest prior art from the subject-matter defined in claim 1.
As far as T 1028/05 is concerned, the board held that evidence was available showing that the use of anti-asthma drugs, including combinations of steroids and bronchodilators, for treating COPD was widespread before the relevant date. Furthermore, it showed that there was a strong opinion in the field that combinations of steroids and bronchodilators were effective for treating COPD. Since the circumstances were completely different, T 1028/05 was not relevant to the present case.
The case is interesting in various aspects.
Public oral disclosure
If the public prior use is not from the opponent himself, even on the balance of probabilities, a public oral disclosure has to be correctly confirmed.
In T 1212/97, the board held that the information content made publicly available by a lecture cannot be put beyond reasonable doubt by any evidence of the lecturer alone, as the lecturer is in a quite different position to a member of the audience, see point 3 ff.
PhD dissertations are not part of the standard search files of the EPO, but are in general public. It is for the opponent using a dissertation in order to support grounds of opposition to provide the exact date at which it became available to the public.
In lot of cases a thesis may be public from the day it is defended. It becomes public at the latest when it is shelved in a public library. But the onus of proof lies with the opponent.
Promise of success – best springboard
The board was satisfied to say that the springboard represented by D5 was way too short to cover the gap between it and D3. In other words, the combination of D5 and D3 boiled down to an ex-post facto argumentation. In the present case a link between D5 and D3 would have been needed.
The combination of D5 and D3 did not have a reasonable expectation of success.
On the contrary, in T 2506/12, the board held that a reasonable expectation of success would allow to deny the required IS. A comparable result is to be found in T 1683/17 which relates to feeding compositions for neonatal infants.
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