T 0409/05 28-07-2009

Summary of Facts and Submissions

I. Mention of the grant of European patent No. 0 721 742 in respect of European patent application No. 96200047.7 in the name of SOCIETE DES PRODUITS NESTLE S.A., which had been filed on 10 January 1996 claiming a US priority of 13 January 1995 (US 372558), was announced on 26 June 2002 (Bulletin 2002/26). The patent, entitled "Nutrition for elderly patients", was granted with nine claims, which correspond to the Main Request dealt with in this decision. Independent Claims 1 and 5 read as follows:

"1. Use of a nutritional composition in the manufacture of a medicament for the treatment or prevention of protein-energy malnutrition in an elderly patient wherein the nutritional composition comprises a protein source for providing at least 18% of the total calories of the composition, a carbohydrate source; a source of dietary fibre having a soluble fibre to insoluble fibre ratio of 1:4 to 4:1, and a lipid source including a mixture of medium and long chain triglycerides."

"5. A nutritional composition for providing nutrition to an elderly patient; the composition comprising: caseinate in an amount to provide at least 18% of the total calories of the composition;

a carbohydrate source in an amount to provide 48% to 55% of the total calories of the composition and which includes a source of dietary fibre having a soluble fibre to insoluble fibre ratio of 1:4 to 4:1; and

a lipid source in an amount to provide 26% to 36% of the total calories of the composition and including a mixture of medium and long chain triglycerides;

2 to 10 mg/l of beta-carotene; and

vitamins and minerals to meet or exceed the US RDA;

the composition having an energy density of 5 kJ/ml (1.2 kcal/ml)."

II. Notices of Opposition were filed against the patent by Fresenius Kabi Deutschland GmbH (Opponent 1) on 17 March 2003 and by Numico Research B.V. (Opponent 2) on 26 March 2003. Both Opponents requested the revocation of the patent in its full scope, relying on Article 100(a) EPC (lack of novelty and lack of inventive step) and Article 100(b) (that the European patent did not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art).

III. The oppositions were inter alia supported by the following documents:

D11: WO 94/27628

D12: Fredstrom S B et al, "Determination of the Fiber Content of Enteral Feedings", Journal of Parenteral and Enteral Nutrition, 1991, 14(4), pp 450-453

D13: Belitz H-D and Grosch W, Lehrbuch der Lebensmittelchemie, 1992, pp 275, 276, 296 and 297

D14: Pak N et al, "A rapid and simultaneous determination of soluble and insoluble dietary fibre", Nutrition Reports International, 1989, 40(3), pp 551-565

D15: Technical Information for the product SUPPORTAN®

D16: Heimburger D C et al, "The Role of Protein in Nutrition, with Particular Reference to the Composition and Use of Enteral Feeding Formulas. A Consensus Report", Journal of Parenteral and Enteral Nutrition, 1986, 10(4), pp 425-430

D21: WO 93/00019

D24: EP 0 564 804

D25: Campbell W W et al, "Increased protein requirements in elderly people: new data and retrospective reassessments", Am J Clin Nutr, 1994, 60, pp 501-509

D28: Internet extract on protein energy malnutrition http://www.ehendrick.org/healthy/001109.htm of 16 November 2004

The following document was filed by the Patent Proprietor:

D31: Internet extract of the Merck Manual of Diagnosis and Therapy on Protein Energy Malnutrition http://www.merck.com/pubs/mmanual/section1/chapter2/2c.htm of 9 October 2003

IV. By its decision announced orally at the oral proceedings of 16 December 2004 and issued in writing on 8 February 2005 the Opposition Division rejected the oppositions. The Opposition Division held that the claimed subject-matter was disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, and that it was novel and not obvious over the cited state of the art.

With regard to the issue of sufficiency it held that the skilled person on the basis of his common general knowledge and the information provided in the patent would have no difficulties in understanding the contested terms "medicament", "protein-energy- malnutrition" and "elderly patients".

With regard to the issue of novelty of Claim 1 it held that none of the cited documents D11, D15, D21 or D24 referred to protein-energy malnutrition (in the following PEM) in an elderly patient. Similarly the subject-matter of Claim 5 was novel over D11, D15 and D21, which did not disclose the claimed amount of caseinate in the nutritional composition.

With regard to the issue of inventive step for both Claims 1 and 5, the Opposition Division considered D16 to represent the closest state of the art because it referred to the use of a composition for the treatment or prevention of PEM in an elderly patient. As regards particularly Claim 1 it argued that the skilled person looking for a composition for that use would not combine the composition of any of D11, D15, D21 or D24 with D16 as he would not find any incentive in those documents to do so. Particularly, as regards Claim 5 it reasoned that the skilled person would not find in any of the cited documents the claimed amount of caseinate and would therefore not arrive in an obvious manner at the claimed solution of the problem.

V. The Opponents appealed the decision of the Opposition Division: Appellant 1 (Opponent 1) on 5 April 2005 paying the appeal fee on the same day and Appellant 2 (Opponent 2) on 7 April 2005 paying the appeal fee on the same day.

VI. The respective Statements setting out the Grounds of Appeal were submitted on 20 June 2005 (Appellant 1) and 17 June 2005 (Appellant 2).

The Appellants maintained their objections of insufficient disclosure, lack of novelty and inventive step.

In support of their arguments Appellant 1 submitted inter alia documents D113 to D118 and Appellant 2 inter alia documents D41 to D43:

D113: Clinical Nutrition, Enteral and Tube Feeding, 2nd ed., 1990, p 392

D114: Parnes H L et al, "Protein Calorie Malnutrition and Cancer Therapy", Drug Safety, 1992, 7(6), pp 404-416

D115: Liebermann M D et al, "Comparison of Acute and Chronic Protein-Energy Malnutrition on Host Antitumor Immune Mechanisms", Journal of Parenteral and Enteral Nutrition, 1991, 15(1), p 15

D116: Nixon D W et al, "Protein-Calorie Undernutrition in Hospitalized Cancer Patients", The American Journal of Medicine, 1980, 68, p 683

D117: Cederholm T, "Protein-Energy Malnutrition in Chronic Disease", The Department of Medicine Stockholm Söder Hospital, Karolinska Institute, Stockholm, Sweden, (1994), abstract and pp 16, 23, 37 and 39

D118: Slavin J, "Nutritional Benefits of Soy Protein and Soy Fiber", Journal of the American Dietetic Association, 1991, 9(7), pp 816-819

D41: Holmes S et al, "Malignant disease: nutritional implications of disease and treatment", Cancer Metastasis Rev, 1987, 6(3), abstract

D42: Parnes H L et al, "Protein calorie malnutrition cancer therapy", Drug Saf, 1992, 7(6), abstract

D43: Rivadeneira D E et al, "Nutritional support of the cancer patient", CA Cancer J Clin, 1998, 48(2), abstract

Within the context of insufficient disclosure, beside the arguments already put forward, Appellant 1 raised the issue of the uncertainty of the ratio of the soluble and insoluble dietary fibres.

The lack of novelty objection against the subject-matter of Claim 1 was maintained in view of the disclosure of D11, D15, D21 and D24. That against the subject-matter of Claim 5 was maintained in view of the disclosure of D11. The main argument was that PEM accompanied cancer and other serious illnesses with the consequence that any cancer-oriented nutrition was at the same time directed towards PEM.

Concerning the objection of lack of inventive step, it was argued that the skilled person starting from D16 as closest state of the art, and looking for a further composition to address PEM would find the solution in any of D11, D15, D21 or D24 as regards Claim 1 and in any of D11 or D21 as regards Claim 5. He would thus arrive at the claimed subject-matter without exercising any inventive skill. Additionally the Appellants argued that apart from D16 any of D11, D15, D21 or D24 could also be considered to represent the closest state of the art. In that case the technical problem to be solved would be either to find a further use for the disclosed nutritional composition (Claim 1) or to improve the composition itself (Claim 5). The solution of the first problem was obvious in view of the prior art document itself or in view of D16 while that of the second was obvious in view of the lack of criticality of the alleged improvement, with the consequence that the claimed limiting parameters must be considered as relating to arbitrary modifications within the general common knowledge of the skilled person in the art.

VII. The Respondent (Patent Proprietor) essentially agreed with the reasoning of the Opposition Division and contested the arguments of the Appellants. In support of its arguments the following documents were submitted:

D32: The Merck Manual of Geriatrics, Section 8, Chapter 61, Protein-Energy Malnutrition, http://www.merck.com/mrkshared/mmg/sec8/ch61/ch61a.jsp of 14 December 2005

D33: Visvanathan R, "Under-Nutrition in Older People: A Serious and Growing Global Problem!", J Postgrad Med, 2003, 49(4), pp 352-360 http://www.jpgmonline.com/article.asp?issn=0022-3859; year=2003;volume=49;issue... of 14 December 2005

Exhibit A: Vahlquist Bo, "A Two-Century Perspective of some major Nutritional Deficiency Diseases in Childhood", Acta Paediadr Scand 64, 1975, pp 161-171

Exhibit B: Bulletin de terminologie Nº 28/F, Terminologie de l'alimentation et de la nutrition, FAO, 1976, pp 24-27

VIII. On 28 July 2009 oral proceedings were held before the Board. At those oral proceedings the Respondent filed as Auxiliary Request a set of claims which was based on granted Claims 5 to 9 with the necessary adjustment of the claims dependency.

IX. Both Appellants (Opponents) requested that the decision under appeal be set aside and that the European patent No. 0 7210742 be revoked.

The Respondent (Patent Proprietor) requested that the appeals be dismissed or the European patent be maintained on the basis of the claims of the Auxiliary Request of 28 July 2009.

X. The arguments put forward by the Appellants (Opponents) in their written submissions and at the oral proceedings can be summarized as follows:

Main Request

- The claimed invention was not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.

- The opposed patent was silent about the way a medicament could be obtained from the disclosed nutritional composition. Should the Respondent consider that the term "medicament" meant something different than a nutritional composition, the subject-matter of Claim 1 would not be clearly and fully disclosed.

- Neither the opposed patent nor the state of the art gave a clear definition of PEM and it was impossible to conclude which conditions were covered by that term and which were not. Under those circumstances the patent did not instruct the skilled person as to the conditions under which the claimed nutritional composition should be used.

- The patent referred to "protein depletion" which might be corrected by high protein intake; this term might also correlate to conditions such as immunological deficiencies, skin breakdown and decrease of body protein stores caused from age; however, that was not a definition of PEM and age could not be considered a disease.

- Furthermore there was no agreed definition in the state of the art for the term PEM when applied to elderly persons; in the state of the art PEM was essentially related to the severe symptoms caused by protein deficiency in undernourished young people, especially sucklings/infants, in the third world.

- To the extent that Exhibits A and B submitted by the Respondent referred to pathological conditions of PEM in general, such conditions were not specified.

- Furthermore, the claim concerned not only the treatment but also the prevention of PEM; therefore it did not necessarily address a pathological condition.

- In conclusion, in the absence of a clear and unequivocal definition of PEM, and in view of the very broad variation in its interpretation in the art, this essential feature was not sufficiently disclosed for the reproduction of the invention across its claimed scope.

- The opposed patent did not disclose the method according to which the ratio of soluble/insoluble fibre was measured. In fact D118 and D119 disclosed various methods providing very different results.

- Contrary to the allegation of the Respondent, in the absence of evidence the skilled person would not automatically consider that the method according to AOAC was the established method.

- Furthermore the subject-matter of Claim 1 lacked novelty over the disclosures of D11, D15, D21 and D24. These documents disclosed both a nutritional composition and its use according to Claim 1.

- For the comparison of the claimed subject-matter with the disclosure of those documents, the unclear terms "prevention of PEM" and "elderly patients" were to be given the broadest interpretation.

- Contrary to the allegation of the Respondent the cited documents disclosed nutritional compositions which were implicitly disclosed to be suitable for the prevention or treatment of PEM. Such an implicit disclosure was supported by D113-D117, according to which PEM was a secondary condition related to a primary disease, such as cancer and gastrointestinal problems.

- Thus according to D11, a person afflicted with cancer would implicitly suffer or be at risk of suffering from PEM. It was important in this context that D11 did not concern the treatment of cancer but the treatment of patients suffering from cancer. The conditions of such patients included PEM or pre-PEM conditions. The limitation of the group of patients to elderly people according to the patent in suit was not a genuine selection since statistically the majority of people suffering from cancer were elderly people.

- According to D15 patients treated for cancer suffered also from inadequate protein supply.

- As regards D21 it explicitly disclosed elderly patients who were unable to chew and swallow food and risked PEM. The way of feeding the liquid nutritional product to those patients did not distinguish the claimed subject-matter from the disclosure of D21 because also the patent (see paragraph [14]) disclosed a nutritional diet for tube use.

- Finally D24 disclosed patients suffering from depletion of lean body mass whose specific metabolic needs were met by a liquid nutritional product. D24 made specific reference to extremely malnourished patients and even explicitly mentioned protein-energy malnutrition.

- In view of the cited state of the art the skilled person would be aware that there was an overlap between on the one hand patients suffering from cancer (D11 and D15), unable to chew and swallow (D21) or suffering from slow wound healing (D24) and on the other hand those who suffered or risked suffering from PEM.

- In all those documents a deficit in proteins was disclosed, which was obviously related to PEM. All the more, these documents disclosed the treatment with a nutritional composition comprising a high level of proteins which in view of the comparable amount of protein in the claimed subject-matter would be understood to mean treatment of PEM.

- Beside the claimed use the claimed nutritional composition was also disclosed in D11, D15, D21 and D24.

- Contrary to the argument of the Respondent, D11 disclosed the claimed ratio of soluble/insoluble fibres (bottom of page 3; Table 6; claim 7).

- This ratio was not explicitly disclosed in D24. It could, however, be derived from the use of soy polysaccharide as source of dietary fibre because soy polysaccharide was always a mixture of soluble and insoluble dietary fibres; that the claimed ratio was indeed met could be inferred from the information in D118 which enabled the determination of this ratio.

Auxiliary Request

- That request should not be admitted because it was filed at a very late stage and was not obviously novel and inventive.

- The subject-matter of Claim 1 (corresponding to granted Claim 5) lacked novelty over the disclosure of D11. Table 6 disclosed less than 18% of the total calories of the composition originating from caseinate; however, D11 taken as a whole, encompassed the possibility of an at least 18% contribution of caseinate. In particular Tables 1 and 2 disclosed that the total protein contribution was about 19% [page 9, lines 9-11 together with claim 6 disclosed values of more than 18%].

- The preciseness of the caloric contribution measurement in D11 could not be criticized because also according to the sole example of the opposed patent (table of page 6) the calculated caloric protein contribution was 17,9% ie below the claimed minimum value of 18%; the latter value was therefore not to be understood as a numerically exact limit.

- Nor could a distinction be made over D11 on the basis of its use as protein source of a combination of soy protein isolate and sodium caseinate because - due to the term "comprising" in present Claim 1 - the presence of eg soy protein isolate in addition to caseinate was not excluded.

- Additionally the subject-matter of Claim 1 lacked an inventive step in view of the disclosure of D11 considered alone or in combination with the general technical knowledge of the person skilled in the art.

- The technical difference of the claimed subject-matter from the disclosure of D11 was the amount of caseinate in the nutritional composition which provided at least 18% of the total calories of the composition. Even on the assumption that D11's disclosure failed to disclose exactly an amount of caseinate meeting this requirement, this feature could not contribute an inventive step because it set an arbitrary limit that was uncritical in the absence of any evidence exhibiting a surprising effect or property of the nutritional composition related to the increase of the caseinate in the protein composition.

XI. The Respondent (Patent Proprietor) essentially argued as follows:

Main Request

- The new documents submitted by the Appellants, namely D113 to D118 and D41 to D44, should not be admitted into the proceedings as they were late filed and not sufficiently relevant to prejudice the maintenance of the opposed patent.

- Contrary to the objections raised by the Appellants, the claimed invention was disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, the claimed subject-matter was novel and involved an inventive step.

- In the context of the present invention the meaning of the term "medicament" as used in Claim 1 was the same as "nutritional composition"; this term could not therefore be construed to give rise to any lack of sufficiency.

- As regards PEM there was no universally agreed definition because PEM might arise as a complication of various different diseases. However, there was no doubt that this was an accepted and recognised medical condition (see Exhibits A and B). PEM was a body condition indicating too low an availability of proteins. Exhibits A and B confirmed that PEM was defined by certain pathological conditions and thus corresponded to a pathological status. In the medical profession PEM was understood to relate to protein deficient persons, whose health was already affected or particularly at risk if, being elderly, they fell ill (see D41).

- Even if in the state of the art PEM was especially related to infants and children, it was obvious that it could also relate to elderly people.

- As regards the method used for establishing the ratio of soluble/insoluble fibres it was admitted that this was not provided in the opposed patent. Nonetheless, it was obvious that the skilled person would apply the method according to AOAC, which was the established method for that type of measurement.

- Concerning the novelty of the subject-matter of Claim 1, none of D11, D15, D21 and D24 disclosed the claimed use. In none of these documents were the primary diseases linked to PEM. Though PEM could be associated with cancer, the fact that it concerned a different condition established a distinction. Furthermore, the Appellants were wrong to assert that the great majority of cancer patients were elderly people.

- Concerning the claimed nutritional composition, it was admitted that D21 disclosed such a composition having all the features disclosed in Claim 1. The same conclusion could not be drawn with regard to D11 because this document failed to identify the claimed ratio of soluble/insoluble fibres.

Auxiliary Request

- The Auxiliary Request should be admitted, since it corresponded to claims which formed part of the Main Request and could not surprise the Appellants. Furthermore the Appellants had already raised objections against the patentability of this subject-matter.

- The nutritional composition of Claim 1 (corresponding to granted claim 5) was novel over the disclosure of D11 for the reasons set out above, namely because this document failed to disclose (i) a caloric contribution of at least 18% of caseinate and (ii) the claimed ratio of soluble/insoluble fibres.

- The subject-matter of Claim 1 was also not obvious in view of the disclosure of D11, contrary to the allegations of the Appellants.

- The technical problem to be solved was to provide a nutritional composition for elderly patients. The solution could not be found in the state of the art. D11 itself disclosed a maximum of 15% of total calories from caseinate.

- Moreover, D11 taught away from the claimed invention as it focused on the fat profile of the composition and did not specifically concern the elderly. In addition to that it disclosed that the soy protein isolate was an important constituent of the nutritional composition which could not be neglected as the protein source and could not be fully replaced by protein from caseinate.

- The Appellants' arguments were based on an arbitrary mosaicing of features found in D11 and the other cited state of the art. Such a combination was based on hindsight.