T 1218/06 18-02-2010

Reasons for the Decision

1. The appeal is admissible.

2. Late filed documents D24/D25

2.1 D24 is a sworn declaration in Spanish by an employee of Nutricia S.R.L. Madrid, Mr Irzo Asensio. As apparent from the English translation D25, Mr Irzo Asensio declares that he has submitted at least one copy of D15 to an institution/person without any obligation to secrecy during the period prior to 23 June 1997 (the priority date of the opposed patent).

D24 and D25 were filed at a very late stage of the appeal proceedings with letters of 10 and 15 February 2010, ie eight and three days prior to the date of oral proceedings before the board.

2.2 According to Article 12(2) of the Rules of Procedure of the Boards of Appeal, the statement of the grounds of appeal shall contain the appellant's complete case. Furthermore, it is established case law of the boards of appeal that late-filed evidence should only very exceptionally be admitted into the proceedings in the appropriate exercise of the board's discretion under Article 114(2) EPC, if such new material is prima facie highly relevant in the sense that it can reasonably be expected to change the eventual result and is thus highly likely to prejudice maintenance of the European patent (see T 1002/92 (OJ EPO 1995, 605; point 3) as an illustration of this case law).

2.3 In the present case, already during oral proceedings before the opposition division on 9 May 2006, it had been decided that D15 did not form prior art. Consequently, the appellant knew at the latest from that date on that the public availability of D15 had not been sufficiently proven. Therefore, any evidence overcoming this deficiency should have been provided with the statement of grounds of appeal, in accordance with Article 12(2) of the Rules of Procedure of the Boards of Appeal.

2.4 During oral proceedings before the board, the appellant stated that filing D24/D25 only shortly before the date of oral proceedings was due to difficulties in finding a person that could confirm the public availability of D15.

However, this argument is not convincing, because the person who gave the declaration, Mr Irzo Asensio, still is an employee of Nutricia S.R.L., ie the company which issued D15. No reasons were given why an inquiry within said company could not have been made earlier.

2.5 Furthermore, the filing of D24/D25 cannot be considered as a reaction to any of the respondent's replies or the board's communication. On the contrary, as has been set out above, the public availability of D15 has already been an issue in the decision under appeal.

2.6 Thus, the filing of D24 and D25 was not in due time in the sense of Article 114(2) EPC.

2.7 With regard to prima facie relevance of D24/D25, the situation is as follows:

2.7.1 The declaration does not contain any details about the question of who has received copies of D15, but only cites in general terms medical institutions and health professionals. The declaration does also not contain any concrete date at which said copies have been distributed, but only refers in general terms to the time period prior to 23 June 1997. Thus, in the board's view, the declaration lacks corroboration about the exact circumstances at which the alleged events took place.

2.7.2 The appellant held the view that the statements in D24/D25 were corroborated by the expiry date "BEST BEFORE 18-06-97" printed on the product depicted in D15, which was prior to the priority date of the opposed patent, and the market authorisation D6 for this product which was issued equally prior to the priority date of the opposed patent.

However, the appellant's argumentation is not convincing for the following reasons:

The words "BEST BEFORE 18-06-97" are just legible on the photograph of a tube-feeding bag at the top right of the first page of Dl5 (at least on the enlarged view D20). This date presumably means 18 June 1997 which is 5 days before the priority date of the patent in suit. However, the date shown on the bag depicted in D15 does not relate directly to the date of D15 as a document. As pointed out by the respondent, it is merely a date printed on the particular bag that was photographed as the date by which the product should be used but there is no evidence as to whether this photograph shows a real product, a prototype or even a dummy product. Even if the photograph shows a real product from an actual production batch, the significance of the date is very limited in that the only assumption that can be made is that the photograph cannot have been taken before the date on which batches with that "best before" date would have been packaged, but no evidence has been presented as to what that date might have been. The fact that the photograph could not have been taken before a particular date does not mean that it was taken on or near to that date and it could have been taken at any time thereafter, quite possibly well after the priority date. Similarly, and even more importantly, the brochure D15 including the photograph could have been produced at any time after the photograph was taken.

As regards D6, this document purports to be a marketing authorisation regarding "Pentaset Fibra" (ie the product referred to in D15) issued by the Ministry of Health and Consumer Affairs (Ministerio de Sanidad y Consumo) in Spain. However, a marketing authorisation does not prove that anything was ever marketed, and even if this were to be the case, it still cannot possibly provide evidence that brochures apparently relating to the product were part of the state of the art before the priority date of the patent in suit.

2.7.3 In summary, D24 and D25 cannot be considered to be prima facie highly relevant according to the established case law (see T 1002/92 mentioned above).

2.8 In view of the above, the board exercised its discretion not to admit D24 and D25 into the proceedings (Article 114(2) EPC).

Main request

3. Amendments

3.1 Claim 1 of the main request differs from Claim 1 as granted in that

(a) the wording "a viscous soluble fibre selected from the group comprising" has been replaced by the wording "a viscous soluble fibre selected from the group consisting of", and

(b) the percentages of energy provided by the protein, lipid and carbohydrate source have been added into the claim.

3.2 Amendment (a) of Claim 1 of the main request is based on page 3, lines 26-30 of the application as filed.

Amendment (b) is based on the passage on page 4, line 34 to page 5, line 31 of the application as filed.

3.3 Since, furthermore, the amendments do not extend the scope of granted Claim 1 and are clear, no objections under Articles 84, 123(2) or 123(3) EPC arise against Claim 1 of the main request. Nor was any objection raised by the appellant in this context.

4. Sufficiency of disclosure

4.1 The feature "viscous soluble fibre" in Claim 1

Claim 1 of the main request contains the term "viscous soluble fibre". The appellant argued that the claimed invention could not be carried out with pectin, which was one of the viscous soluble fibres cited in Claim 1. According to D12, viscous soluble fibres such as pectin and psyllium had little or no effect on the glucose rise after glucose ingestion ('Mechanism of Action' on page 505 of D12, right hand column). Thus, pectin was not suitable for the preparation of a liquid composition for the nutritional management of diabetes.

However, the passage in D12 relied upon by the appellant refers expressis verbis to "little or no effect". Thus, the passage itself cannot provide incontestable proof for the appellant's allegation that pectin would be unsuitable for the preparation of a liquid composition for the nutritional management of diabetes. Furthermore, it is apparent from Table 2 of D12 that various other antithetic results are reported on the efficiency of pectin. More in particular, Holt et al. reported a reduction of glucose rise caused by pectin fibres while the opposite was found by other authors. In view of the above, D12 cannot support the appellant's allegation that pectin has no beneficial effect at all and would therefore be not suitable for the claimed use. Hence, no evidence is available that the invention cannot be carried out with pectin as viscous soluble fibre. In the absence of any evidence and in view of the fact that the burden of proof in opposition proceedings rests on the opponent (T 182/89, OJ EPO 1991, 391; headnote), the term "viscous soluble fibre" in Claim 1 does not give rise to any objection under Article 83 EPC.

4.2 The feature "for the nutritional management of diabetes" in Claim 1

The appellant argued that it was unclear to the skilled person what had to be understood by the term "for the nutritional management of diabetes" in Claim 1.

However, contrary to the position of the appellant, the term in question is quite clear. For example, the patent in suit states at paragraph [0002] that:

"Diabetes is a general term for a group of metabolic disorders which are characterised by the inability to properly metabolise glucose. …, if untreated, the inability leads to hyperglycaemia and its complications of morbidity and mortality."

This could not be clearer and, in any event, any person with experience in the field knows that diabetes is all about blood sugar level; many diabetics monitor this level themselves daily or even several times daily. Management of diabetes is thus management of blood sugar level and particularly managing post-prandial glycaemia. This in turn will manage the other physical manifestations of diabetes and the complications referred to in the passage quoted above. The word "nutritional" makes it clear that management takes place by adjusting the diet of the patient and not by administration of exogenous insulin or antihyperglycaemic drugs.

For the above reasons, the objection that the European patent does not provide sufficient disclosure of what is meant by nutritional management of diabetes for the person skilled in the art to put the invention into practice is clearly without foundation.

Irrespective of the above, it appears that the appellant's objection relates to lack of clarity rather than sufficiency of disclosure. No evidence has been provided by the appellant that, due to the alleged unclarity, the feature covers types of management that could not be achieved with the teaching of the opposed patent. Also for this reason, the appellant's objection must fail.

4.3 The viscosity in Claim 2

4.3.1 Dependent Claim 2 of the main request reads as follows:

"The use according to claim 1, wherein the liquid nutritional composition has a viscosity, when measured at room temperature, of 0.015 to 0.03 kg/ms."

4.3.2 The appellant held the view that the European patent did not provide sufficient information as to how viscosity was measured to put the invention into effect. In particular, it was not indicated which shear stress and shear rate had to be applied in the viscosity measurement. However, the patent in suit does, in fact, teach the person skilled in the art exactly how viscosity is to be measured. In paragraph [0054] the patent in suit says in the context of Example 3 that:

"The viscosity of each composition is determined at 25ºC using a Contraves Rheomat according to the manufacturer's instructions".

4.3.3 As pointed out by the respondent, the Contraves Rheomat is a commonly used rheometer with which the person skilled in the art would be likely to be familiar, but in case of any doubt reference could be made to the manufacturer's instructions that come with this piece of equipment. No evidence was provided by the appellant that said instructions were insufficient (in particular with respect to shear stress and shear rate) to carry out the viscosity measurement. For this reason alone, the appellant's argument is not convincing.

Consequently, the viscosity cited in Claim 2 cannot lead to any insufficiency of disclosure.

4.4 In summary, the main request meets the requirements of Article 83 EPC.

5. Novelty

5.1 The appellant cited D15 as novelty-destroying. A precondition for a document to be novelty-destroying is its public availability before the filing date and the priority date, respectively, of the opposed patent. According to the appellant, said public availability was proven by the expiry date printed on the product shown in D15 and by the market authorisation D6.

As has been set out in point 2.7.2, above, said expiry date and market authorisation D6 are per se unsuitable to prove the public availability of D15 before the priority date of the opposed patent. Hence, no valid proof for the public availability of D15 is available. D15 is therefore not state of the art within the meaning of Article 54 EPC. Consequently, novelty of the subject-matter of the main request over D15 is acknowledged.

5.2 The public prior use having allegedly occurred in connection with "Pentaset Fibra", ie the product shown in D15, was not pursued by the appellant during oral proceedings. Since, furthermore, said alleged public prior use has not been sufficiently substantiated in the written submissions, novelty in view of this alleged public prior use has to be acknowledged.

6. Inventive step

6.1 Selection of the closest prior art

The object of the claimed subject-matter is the provision of a liquid nutritional composition suitable for diabetic patients and having good flow characteristics so that it can be used in tube-feeding (page 2, lines 34, 46 - 47 and 56 - 57 of the patent specification).

D1, D9 and D12, though related to the therapeutic benefits of fibres in diabetes, do not address the problem of flow characteristics and tube-feeding.

D7 refers to a method of lowering the viscosity of food compositions. The nutritional management of diabetes in the widest sense is mentioned on page 1, lines 10 - 14. However, this passage only refers to prior art uses of dietary fibres in general and does not represent an object of D7 itself.

On the other hand, D10 is directed to liquid nutritional compositions comprising a lipid fraction, a protein fraction and a specific combination of glucides useful as dietetics and therapeutics for diabetic patients. The compositions have good flow characteristics which allow an optional administration by digestive probe (column 1, lines 38 - 49, column 3, lines 12 - 20 and column 4, lines 39 - 45). Further, Example 1 of D10 describes the preparation of a dietary and/or therapeutic liquid composition for oral or enteral use for administration by digestive probe. Thus, D10, and in particular Example 1 of D10, has to be considered to represent the closest prior art.

6.2 Distinguishing features

The liquid dietary and/or therapeutic composition of Example 1 of D10 is obtained from

- 11 g glucides (corresponding to the carbohydrate source cited in Claim 1) including

- pectin (corresponding to the viscous soluble fibre cited in Claim 1),

- 2.67 g lipids (corresponding to the lipid source as cited in Claim 1), and

- 3 g proteins (corresponding to the protein source as cited in Claim 1).

In a clinical study, the product of Example 1 was consumed daily by six diabetics of type II (paragraph bridging columns 6 and 7), corresponding to a nutritional management of diabetes as cited in Claim 1.

The subject-matter of Claim 1 of the main request differs from Example 1 of D10 in that

- inulin or a hydrolysate thereof (in the following, the term "inulin" is used for "inulin or a hydrolysate thereof") is additionally present in the composition to be used and

- the energy contributions of the carbohydrate, lipid and protein source are not specified.

6.3 Objective technical problem

6.3.1 The problem relied upon by the respondent in the assessment of inventive step was the problem stated in the opposed patent, namely the provision of a nutritional composition that has an adequately reduced glycaemic response while having good flow characteristics, ie low viscosity, so that it can be used in tube feeding (page 2, lines 34, 46 - 47 and 56 - 57).

With regard to the achievement of good flow characteristics / lower viscosity, the respondent saw this effect demonstrated by a comparison of Product Example 1 in the opposed patent with

(a) Example 1 of D10 and

(b) the commercial product Fresubin DFN Plus, which is a comparative example in the opposed patent.

6.3.2 With regard to comparison (a), the respondent argued that the inulin-free composition of Example 1 of D10 was not used for tube feeding but was applied as oral sip feed in the clinical study of D10. A sip feed would have a higher viscosity than a digestive probe. On the other hand, the inulin-containing Product Example 1 in the opposed patent had the desired low viscosity. Thus, the low viscosity was caused by the distinguishing feature with regard to D10, namely the presence of inulin.

However, even if the product of Example 1 of D10 were applied to the patients as a sip feed, there is nothing in D10 suggesting a high viscosity of the product used in the clinical study of D10, ie the product of Example 1. On the contrary, the liquid composition of Example 1 of D10 is explicitly described as being suitable "for oral or enteral use for administration by digestive probe" (column 5, lines 32 - 33), which, as acknowledged by the respondent during oral proceedings, is tantamount to tube feeding. In addition it is stated in column 3, lines 15 - 20 that "Compositions which have retained a viscosity of less than 0.02 kgm**(-1-1)… and which allow an optional administration by digestive probe, are also preferred". In the absence of any evidence, respondent's remarks appear to be rather an assertion than a convincing line of argumentation. If any assumption concerning the viscosity of the composition of Example 1 of D10 can be made, it is the assumption that the composition has a viscosity of less than 0.02 kgm**(-1-1)as indicated in the text of D10. Since, furthermore, the respondent's line of argument is not supported by any evidence, a comparison of Product Example 1 with Example 1 of D10 can never demonstrate that the presence of inulin would induce good flow characteristics / low viscosity to a composition.

6.3.3 With regard to comparison (b) (Product Example 1 versus commercial product Fresubin DFN Plus), the respondent referred to the first table on page 7 of the opposed patent. This table shows that the inulin-containing composition of Product Example 1 has a viscosity of 0.23 kgm**(-1-1), which is significantly lower than the viscosity for the inulin-free Fresubin DFN Plus (0.035 kgm**(-1-1)), and that the flow rate for Product Example 1 is significantly improved compared to Fresubin DFN Plus (60 and 66 min/500 ml versus 129 and 158 min/500 ml). In the respondent's view, this comparison demonstrated the beneficial effect of inulin on flow rate / viscosity.

However, as acknowledged by both parties, Product Example 1 and the commercial product Fresubin DFN Plus differ not only in the presence of inulin but also in the type of (further) fibres used. More in particular, Product Example 1 uses pectin whereas the commercial product uses soy fibres. As apparent from D7 and D10, this further difference has an influence on the viscosity of the composition.

D7 discloses that "soy fiber when used in tube feeding nutritional products can cause a viscosity increase to the extent such that undesirably low flow rates can occur, or the tubes can even clog in extreme situations" (sentence bridging pages 1 and 2). D10, which aims at low viscosities (as set out in points 6.1 and 6.3.2, above), refers to pectin as preferred soluble fibre (column 5, line 23).

In view of the cited prior art, it must be assumed, that, as pointed out by the appellant, pectin fibres are superior to soy fibres in terms of flow rate / impact on viscosity. Consequently, it is not possible to attribute any improvement in flow rate /reduced viscosity of Product Example 1 of the opposed patent over the commercial product Fresubin DFN Plus to the presence of inulin.

6.3.4 In summary, the comparative data referred to by the respondent cannot constitute any proof that good flow rates / low viscosities are obtained by the distinguishing feature with regard to closest prior art document D10, namely the presence of inulin.

In other words, the comparisons relied upon by the respondent are not a fair comparison with the closest prior art as they do not meet the criterion set out in decision T 197/86 (OJ EPO 1989, 371; point 6.1.3): "… in the case where comparative tests are chosen to demonstrate an inventive step with an improved effect over a claimed area, 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 distinguishing feature of the invention.".

6.3.5 As regards the second distinguishing feature of the claimed subject-matter over the closest prior art, ie the energy distribution specified for the carbohydrate, lipid and protein source, this feature does not lead to any tangible, technical effect, and in particular not to good flow characteristics or low viscosity.

6.3.6 For the above reasons, the achievement of a good flow rate / low of viscosity cannot be taken into account when formulating the objective technical problem. In fact, the problem referred to by the respondent and cited in the opposed patent has to be re-formulated in a less ambitious manner as the provision of a further nutritional composition that has an adequately reduced glycaemic response.

6.4 Obviousness of solution

6.4.1 A person skilled in the art starting from Example 1 of D10 as the closest prior art and faced with the problem of providing alternative nutritional compositions having an adequately reduced glycaemic response would immediately contemplate the addition of inulin to the composition of Example 1 of D10 in view of the first paragraph of page 1 of D2 (English translation of D1) where it reads:

"… inulin - has a stabilising action on the content of glucose in the blood of patients with diabetes mellitus ... Its effect increases in combination with other organic components of Jerusalem artichoke tubers, such as pectins..." (emphasis added by the board).

In view of this explicit teaching of D1, the respondent's argument that a skilled person would not use a combination of inulin and pectin must fail.

Consequently, the presence of inulin cannot contribute to inventive step in view of D10 in combination with D1.

6.4.2 The energy contributions provided by the carbohydrate, lipid and protein source represent an arbitrary selection out of the ranges given for the energy contributions in column 3, lines 52 - 61 of D10 (protein source: 10 - 17% energy intake, lipid source: 20 - 40% energy intake, carbohydrate source: remaining energy intake). Such an arbitrary selection is a matter of routine experimentation. Consequently, as not disputed by the respondent, the energy contributions provided by the carbohydrate, lipid and protein source cited in Claim 1 cannot contribute to inventive step either.

6.5 In summary, the subject-matter of Claim 1 of the main request is obvious over a combination of D10 with D1. Consequently, the main request has to be refused.

7. It may be appropriate to recall at this point that auxiliary request 1 has been withdrawn at the oral proceedings before the board.

Auxiliary request 2

8. Amendments - Article 123(2) and (3) EPC

8.1 Claim 1 of auxiliary request 2 differs from Claim 1 of the main request in that

(a) the amount of energy provided by the protein source has been restricted to 12 to 18% of the energy of the nutritional composition,

(b) the composition has a viscosity, when measured at room temperature, of 0.015 to 0.03 kg/ms,

(c) the fibre mixture further includes a source of insoluble dietary fibre

(d) in a certain ratio of soluble to insoluble fibre.

8.2 Amendment (a) finds its basis on page 5, line 1 of the application as filed. Amendments (b) - (d) are based on granted Claim 2 (corresponding to Claim 3 as filed) granted Claim 3 (corresponding to Claim 5 as filed) and granted Claim 5 (corresponding to Claim 7 as filed). These amendments further limit the scope of the only independent Claim 1.

As not disputed by the appellant, these amendments thus meet the requirements of Article 123(2) and (3) EPC.

9. Amendments - Article 84 EPC

The appellant argued that the viscosity now cited in Claim 1 was unclear, because it was not indicated in the patent in suit which shear stress and shear rate had to be applied in the viscosity measurement. This unclarity had been introduced into Claim 1 by way of amendment and was thus open to an objection under Article 84 EPC. However, as set out in point 4.3, above, the patent in suit provides information about the viscosity measurement, and it has not been shown by the appellant that this information with regard to the measurement of the viscosity was insufficient and/or unclear. Consequently, for this reasons alone, the appellant's argument must fail.

10. Sufficiency of disclosure and novelty

For the reasons given with regard to the main request, also the subject-matter of auxiliary request 2 is sufficiently disclosed and novel.

11. Inventive step

11.1 Claim 1 of auxiliary request 2 contains further restrictions over Claim 1 of the main request. However, none of the further limiting features appears suitable to overcome the inventive step objection against Claim 1 of the main request.

As not disputed by the respondent, the further restriction in energy percentage (amendment (a), above) does not give rise to any technical effect. Said restriction hence cannot add any inventive subject-matter to the subject-matter of Claim 1 of auxiliary request 2.

No technical effect has been attributed by the respondent to the further distinguishing features, namely the restricted viscosity, the presence of soluble and insoluble fibres, or the ratio thereof (amendments (b) - (d), above). Nor is any technical effect associated with these features apparent from the opposed patent.

11.2 Consequently, D10, and in particular Example 1 of D10, remain the closest prior art for the subject-matter of Claim 1 of auxiliary request 2. Since the further limiting features introduced into Claim 1 do not provide any technical effect, the objective technical problem to be solved over the closest prior art remains the provision of a further nutritional composition that has an adequately reduced glycaemic response.

11.3 As set out for the main request, the addition of inulin is obvious from D1 and the energy distribution obvious from the closest prior art itself, namely D10. Without providing any technical effect, the further restriction in the energy provided by the protein source is merely an arbitrary selection from the known broader range.

D10 also discloses a preferred viscosity of less than 0.02 kgm**(-1-1)for nutritional compositions allowing an optional administration by digestive probe (see point 6.3.2, above). Thus, D10 suggests viscosities which fall within the range now required in Claim 1 of auxiliary request 2, ie 0.015 to 0.03 kg/ms.

The presence of soluble and insoluble fibres is recommended for diabetic diets in D9 (point 4 of "CONCLUSIONS" on page 462). Said presence is therefore a commonly known feature, which cannot, in the absence of any technical effect, contribute to inventive step. As regards the ratio of soluble to insoluble fibre in Claim 1 of the main request, said ratio is, in the absence of any technical effect achieved thereby, an arbitrary selection of the fibre amounts. The latter is a matter of routine experimentation that cannot contribute to inventive step.

In the end, amendments (a) - (d) in Claim 1 of auxiliary request 2 are a mere collocation of generally known and/or arbitrarily selected features which cannot alter the finding on inventive step reached with regard to the subject-matter of Claim 1 of the main request.

11.4 In summary, the subject-matter of Claim 1 of auxiliary request 2 is obvious in view of D10 in combination with D1 and D9.