Wednesday, 11 February 2015

T 2540/12 - extrapolation of disclosure closest prior art



This appeal lies from a decision of the Opposition Division filed by the opponent. The Opposition Division maintained the patent as granted and the opponent (Appelant) filed the appeal. In this appeal there was an interesting discussion about inventive step. The subject of the discussion was whether the skilled person would extrapolate results of a scientific study presented in the closest prior art such that he arrives at an embodiment falling within the scope of the main claim of the main request. The study addressed the effects of an early diet of infants on their later life. One has to realize that the effect of the main claim is not really different from the effect of the disclosure of the closest prior art. Another interesting point of this decision is the admissibility of an auxiliary request introduced at the end of the oral proceedings while the same request was withdrawn earlier during the same oral proceedings.

Summary of Facts and Submissions
 

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III. The opposition division's decision was based on the claims as granted, of which claim 1 reads as follows:"1. Use of nutrient in the manufacture of a feeding formula for feeding to human infants in the period up to 2 months of age to avoid long-term adverse health effects consequent upon excessive weight gain in that period, wherein said feeding formula comprises 0.5 to 1.00 grams of protein and 25-50 kilocalories per 100 ml."

The subject-matter of claim 1 differed from the closest prior art document D1 in that a feeding formula was used comprising 0.5 to 1.00 grams of protein and 25 to 50 kilocalories per 100 ml. The objective technical problem was seen as how to find a feeding routine for early postnatal nutrition that reduced the risk of long-term adverse health effects consequent upon excessive weight gain caused by using infant formulae. It was credible that the technical effect of reducing long-term adverse health effects upon excessive weight gain was achieved by the feeding formula as required in granted claim 1. D1 acknowledged a relationship between nutrient-enriched diets given to neonates and obesity in later life. There was however no teaching in D1 to modify existing feeding formulae according to claim 1. D1 merely suggested that breastfeeding was preferable for obtaining the long-term benefit on adiposity. The opponent's argument that the experimental data in D1 would lead the skilled person in an obvious way to the claimed solution in the same way as the experimental data of the opposed patent was not considered to be convincing as this reasoning would be based on hindsight knowledge of the invention. The subject-matter of claim 1, formulated as a plausible prediction on the basis of the experimental data in the contested patent, indeed appeared logical a posteriori. However in the absence of a pointer in D1 to reconsider the energy and protein requirements of commercial feeding formulae in order to solve the above-mentioned objective technical problem, the skilled person would not have arrived at the claimed solution in an obvious way.

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XII. So far as relevant to the present decision, the appellant's arguments can be summarised as follows:
- Main request
The claims of the main request were not based on the application as filed and the invention defined in these claims was not sufficiently disclosed.
Furthermore, the subject-matter of claim 1 was not inventive in view of D1 as the closest prior art. The formula of claim 1 differed from those disclosed in D1 in that the protein and energy content was slightly lower. No data were contained in the opposed patent as to the claimed formula and no effect had been attributed to the slight reduction in protein and energy content. Hence it had to be assumed that the formula of D1 provided the same effect as that of claim 1. Therefore the objective technical problem solved in the light of D1 was the provision of an alternative composition to achieve the same therapeutic effect. D1 already pointed at lowering the protein and energy content since lower protein and energy contents let to lower leptin concentrations and hence less risk of obesity in later life. In this respect, trial 2 of D1 was relevant, in which the use of a non-enriched standard term formula instead of the preterm formula led to a reduction in the leptin concentration of 29%. In view of the respondent's arguments made during the discussion of sufficiency of disclosure (see point 2.5 below), it had to be assumed that the skilled person would extrapolate the trend observed in this trial towards even lower protein and energy contents, such that he would arrive at the subject-matter of claim 1.

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XIII. So far as relevant to the present decision, the respondent's arguments can be summarised as follows:- Main request
D1 was the closest prior art, from which the claimed formula differed in terms of the protein and energy content. The objective technical problem was how to avoid in formula-fed infants the risk of creating long-term adverse health effects. There was no significant difference in D1 between formula-fed infants and infants that had received breast milk, and between infants having received the preterm formula and those having been fed banked breast milk. The skilled person would thus not have been motivated to change the composition of the preterm and term formulae in D1. Furthermore, it was commonly known that breast milk was the "gold standard". Therefore, the fact that the preterm formula in D1 was less beneficial than mother's own expressed breast milk would not induce the skilled person to modify the preterm formula. Also the authors of D22 had realised that formula-fed infants had a higher fasting insulin concentration than breastfed infants but had not suggested modifying the formulae. Finally, there was nothing about insulin resistance in D1 and the skilled person would thus not have been motivated to choose the claimed formula to avoid insulin resistance.

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Reasons for the Decision
 

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2. Inventive step

2.1 The invention underlying the opposed patent relates to the use of infant formulae to avoid long-term adverse health effects consequent upon excessive weight gain (paragraphs [0006], [0007] and [0010] and claim 1 of the patent).

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2.2 D1 is a scientific paper published by a group of authors including the two inventors of the opposed patent. In the same way as in the patent, this paper is dealing with the effects of early diet on later life. The study described in D1 is exactly that disclosed in the patent, i.e. the infant group, study design and formulae (a) to (d) applied in the study of the patent are used in D1 as well (as regards infants and study design of feeding the infants, see paragraph bridging left- and right-hand column on page 994; as regards formulae, see the first full paragraph on the right-hand column of page 994; as regards the study design of the follow up, see the first paragraph on the left-hand column on page 995). The only difference between the study in D1 and that in the opposed patent is that in D1 the relative leptin concentrations indicative for obesity in later life are measured in the follow up (abstract on page 993 and conclusions on page 998), rather than the 32-33 split proinsulin concentration and the flow-mediated endothelial dependent dilation (FMD) in the patent.
D1 is thus in the same technical field and aims at the same objective as the opposed patent. As acknowledged by both parties, D1 therefore can be considered to represent the closest prior art.
In the same way as the diets used for the examples in the opposed patent, the diets used in D1 are different from the formula defined in claim 1 of the opposed patent in that the protein and energy contents in D1 are slightly higher than those of the formula according to claim 1.

2.3 According to the respondent, the problem solved by the patent was how to avoid, in the case of formula-fed infants, the risk of creating long-term adverse health effects.

2.4 As a solution to this problem, the patent proposes the use according to claim 1, characterised in that an infant formula is applied with a slightly lower protein and energy content than that present in the term formula of D1, namely 0.5-1.00 g/100ml of protein and 25-50 kcal/100ml.

2.5 It needs to be examined whether this problem has been credibly solved by the claimed subject-matter, i.e. by the lower protein and energy contents required by claim 1.
During the discussion of sufficiency of disclosure during the oral proceedings before the board, the respondent explained that the skilled person looking at the experiments in the study described in the opposed patent would have reasonably expected that the trend observed in this study, namely that lower protein and energy contents led to lower insulin resistance and endothelial dysfunction, could be extrapolated to the even lower protein and energy contents required by claim 1. In other words, the skilled person would have expected that at these even lower protein and energy contents, insulin resistance and endothelial dysfunction would be avoided.
The board accepts this argument and therefore considers it to be credible that the above problem (point 2.3) is solved by the subject-matter of claim 1. This problem thus represents the objective technical problem.

2.6 It needs finally to be examined whether in view of this problem, the claimed solution is obvious.

2.6.1 In trial 2 of D1, children fed the term formula were compared to children fed the preterm formula (figure 1 on page 994). It was found that children who had received the term formula (with a lower protein and energy content, see point 2.1.1 above) had a leptin concentration at the age of 13 to 16 years that was 29.0% lower than children who had received the preterm formula (trial 2 in table 3 on page 997 and lines 10 to 16 of the left-hand column on page 998 of D1), and this correlated to a lower risk of obesity in later life (lines 4 to 6 of the right-hand column on page 997 of D1).
Hence, exactly the same trend is described in D1 as in the patent, namely that a lower protein and energy content of the term formula reduces adverse health effects in later life (obesity in D1 and insulin resistance and endothelial dysfunction in the opposed patent).

2.6.2 Accepting the respondent's argument that in the patent this trend can be extrapolated to lower protein and energy contents as required by claim 1, which the board does (point 2.5 above), the same must be assumed for D1. More specifically, in the same way as for the study described in the patent, it must be assumed that the skilled person reading D1 would expect that by reducing the protein and energy content of the term formula in D1 even further, the risk of obesity in later life would be avoided. The skilled person seeking to achieve this avoidance would thus reduce the protein and energy content of the term formula of D1 and would thereby arrive at the subject-matter of claim 1. This subject-matter is therefore obvious in view of D1.

2.7 The respondent's arguments made as regards inventive step are in this respect not convincing:

2.7.1 The respondent argued that there was no significant difference in D1 between formula-fed infants and infants that had received breast milk and between infants having received the preterm formula and those having been fed banked breast milk. The skilled person would thus not have been motivated to change the composition of the preterm or term formulae in D1.
However, this argument is not relevant since D1 contains a comparison of infants fed with a term formula and those fed with a preterm formula and since, as has been set out above, in view of this comparison the claimed subject-matter is obvious.

2.7.2 The respondent also argued that it was commonly known that breast milk was the "gold standard". Therefore, the fact that the preterm formula in D1 was less beneficial than mother's own expressed breast milk would not induce the skilled person to modify the preterm formula. Also the authors of D22 had realised that formula-fed infants had a higher fasting insulin concentration than breastfed infants but did not suggest modifying the formula.
However, in the same way as for the respondent's first argument, this argument disregards the fact that D1 contains a comparison between a preterm and a term formula and that, on the basis of this comparison, the claimed subject-matter is obvious.

2.7.3 The respondent further argued that there was nothing about insulin resistance in D1.
This argument is not relevant either since claim 1 is not restricted to the avoidance of insulin resistance but covers the avoidance of adverse health effects in general.

2.8 The subject-matter of claim 1 therefore lacks inventive step in view of D1.

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Auxiliary request

4. Admissibility

4.1 The auxiliary request (hereinafter "new auxiliary request") was filed at approximately 2.50 pm during the oral proceedings before the board. Pursuant to Article 13(1) RPBA, it is at the board's discretion to admit or not to admit the new auxiliary request. This discretion shall be exercised in view of inter alia the need for procedural economy. When exercising this discretion, the board has to take into account the respondent's behaviour during the oral proceedings (T 1790/06, point 16). To decide on the admissibility of the new auxiliary request, it is therefore necessary to reiterate the course of the present oral proceedings, including the respondent's latest written submissions.

4.2 With letter dated 17 December 2014, the respondent had filed two auxiliary requests, namely an AUXILIARY REQUEST and an AUXILIARY REQUEST 2 (see point IX above). Oral proceedings were held on 13 January 2015 and started with the discussion of the respondent's main request. After the board had announced its opinion that the main request was not inventive, the respondent withdrew its AUXILIARY REQUEST filed with letter of 17 December 2014. Subsequently, the admissibility of AUXILIARY REQUEST 2 was discussed, focusing on problems arising due to the amendment of the time period defined in claim 1. This AUXILIARY REQUEST 2 was again withdrawn and new auxiliary requests 2 and 3 were filed. The admissibility of these two requests was then discussed, again focusing on problems concerning the now differently amended time period in claim 1. Also these auxiliary requests were subsequently withdrawn and at approximately 2.50 pm the new auxiliary request was filed.
The new auxiliary request is in essence identical to the AUXILIARY REQUEST filed with letter of 17 December 2014 but then withdrawn in the oral proceedings. The filing of the new auxiliary request thus essentially represents a re-introduction of the withdrawn AUXILIARY REQUEST, after several hours of discussion on several other also later withdrawn auxiliary requests. Because of the way in which the requests were filed and later withdrawn, the discussion during the oral proceedings went in circles, such that the conduct of the oral proceedings became very inefficient. The respondent thereby did not comply with its duty as regards the efficient conduct of the oral proceedings (T 1790/06, point 16).

4.3 The respondent argued that proceedings before the boards of appeal were about giving justice to all parties and the oral proceedings should therefore be conducted so as to find out whether the new auxiliary request was allowable.
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The board accepts that the way the respondent acted during the oral proceedings did not entail any devious intent. Nevertheless, as set out above, the respondent's behaviour impaired the efficient conduct of the oral proceedings and this in itself was sufficient reason not to admit the new auxiliary request.

4.4 The board therefore decided not to admit the new auxiliary request into the proceedings.

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Order

For these reasons it is decided that:
1. The decision under appeal is set aside.
2. The patent is revoked.



This decision has European Case Law Identifier: ECLI:EP:BA:2015:T254012.20150113. The whole decision can be found here. The file wrapper can be found here. Comic obtained from xkcd.

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