T 1335/05 (Universal test system/DADE BEHRING) 23-01-2008

Reasons for the Decision

1. The appeal is admissible.

Admission of the appellant's submissions dated 28 December 2006 into the proceedings

2. The submissions filed by the appellant with letter of 28 December 2006 constitute a mere response of the appellant to the reply of the respondent to the statement of the grounds of appeal. The response is not complex and does not complicate the proceedings, it was filed before the board summoned the oral proceedings, does not request the introduction of new evidence into the procedure and is considered to contribute, rather than hamper, the procedural economy of the case. Accordingly, the board applies its discretion to admit this submission into the proceedings pursuant to Article 13 of the Rules of Procedure of the Boards of Appeal (OJ EPO 2007, 536).

Interpretation of claim 1 of the new main request

3. In accordance with established principles, the skilled person, when considering a claim, should rule out interpretations which are illogical or which do not make technical sense. He should try, to arrive at an interpretation of the claim which is technically sensible and takes into account the whole disclosure of the patent (see Case Law of the Boards of Appeal of the European Patent Office, 5th edition, 2006, page 205).

4. Amended claim 1 requires that the claimed test system is capable of identifying a microorganism in a sample, wherein the test system is capable of identifying that microorganism from groups of widely divergent microorganisms, comprising yeast and all of anaerobic bacteria, enteric bacteria, the gram positive group of bacteria, neisseria and Haemophilus and fastidious bacteria.

5. The respondent has argued that claim 1 needs to be interpreted as merely requiring the test system to be capable to identify at least one microorganism (to the species).

6. The board considers, however, that the skilled person commonly understands the feature "capable of identifying that microorganism from groups of widely divergent microorganisms, comprising yeast and all of anaerobic bacteria, enteric bacteria, the gram positive group of bacteria, neisseria and Haemophilus and fastidious bacteria" as requiring the test system to identify a microorganism from each of the referred to groups of microorganisms, i.e. the claimed test system has the desired universal capability of not being restricted to any group or groups of microorganisms. It can identify microorganisms whatever group they may belong to.

7. The board notes that the claim construction of the board finds confirmation in paragraph [0040] of the patent in suit which states that "[t]he number of tests disposed on a universal test panel of the present invention is sufficient to identify a single microorganism in a sample belonging to any one of a number of widely divergent groups" (emphasis added).

8. The board therefore concludes that, in the light of the description, the skilled person would not interpret claim 1 in the manner as advocated by the respondents.

Articles 84, 123(2) and 123(3) EPC

9. Since the requirements of Article 84 EPC are not a ground of opposition and the ground of opposition under Article 100(c) EPC has not been invoked within the framework of the present opposition proceedings, the examination of the requirements of Articles 84 and 123(2) EPC of the claims of the appellant's request is restricted to amendments made over the patent in its granted form (see also T 503/03 of 29 November 2005, point 11 and T 936/02 of 21 December 2006, point 3). Also in the context of Article 123(3) EPC, the claims of the requests need comparison to the claims as granted.

10. Independent claims 1 and 18 and dependent claim 19 of the appellant's request differ from the two independent claims 1 and 27 and dependent claim 28 as granted in two aspects.

Firstly in the preamble of the claims the feature that the test system (or a method) is capable of identifying the microorganism from (among) groups of widely divergent microorganisms, comprising yeast and at least one of the five specifically cited groups of microorganisms is amended to the extent that the test system is now capable of identifying that microorganism from (among) groups of widely divergent microorganisms, comprising yeast and all of the same five specifically cited groups of microorganisms. The board judges that the subject-matter as now defined is clearly and unambiguously derivable from claims 1 and 27 and dependent claim 28 as granted seeing that the amended feature relates to one of the possible groups of widely divergent microorganisms enumerated in these claims, i.e. at least one also discloses all.

Secondly, the amendment in the independent claims that the identification is "to the species" finds a basis in claim 2 as granted and page 19, lines 17 to 20 of the application as filed.

11. From the finding above it follows that the amendments to the preamble of the claims and the amendments that the identification is "to the species" restrict the protection provided by the claims as amended as compared to the protection provided by the patent in suit.

12. The respondent has argued that in view of paragraph [0040] of the patent in suit, the amendment concerning the extension of the group of widely divergent microorganisms to all of the six groups and the identification to the species inevitably lead to a change of the number (increase) of predetermined combination of non-redundant biochemical tests in the test system. However, rather than providing an indication that the protection provided by claims as amended was extended as compared to the protection provided by the patent in suit, the board considers this argument in fact to support the restriction of the provided protection.

13. In view of the above considerations the claims of the appellant's request comply with the requirements of Articles 84, 123(2) and 123(3) EPC.

Admission into the proceedings of documents D6 to D10

14. The respondent filed documents D6 to D10 with letter dated 7 April 2006 in response to the statement of the grounds of appeal. At the oral proceedings, the appellant consented to the introduction of these documents into the proceedings.

15. According to the case law of the Boards of Appeal late filed evidence may only be introduced into the proceedings if particular conditions are met. The later in the procedure the new evidence is filed the stricter it is scrutinised for its relevance. In principle the new material must be prima facie "highly" relevant in the sense that it is likely to prejudice maintenance of the European patent.

16. For the reasons given below the Board considers documents D1, D2 and D4 not to belong to the state of the art pursuant to Article 54(2) EPC. Document D6 is highly relevant in the sense of the case law of the boards of appeal for the assessment thereof (see point 28 below). Furthermore, documents D7 to D10 refer to the same subject-matter as documents D1, D2 and D4 and it is undisputed that they are contained in the prior art. The documents are furthermore highly relevant in the sense of the case law of the boards of appeal. Therefore, the board exercises its discretion provided by Article 114(2) EPC and admits these documents D6 to D10 into the proceedings.

Article 54(2) EPC, state of the art

17. The disclosures in documents D1, D2 and D4 are undisputedly highly relevant for the question of patentability of the claimed subject-matter. Therefore it has to be considered whether they were made available to the public before the priority date of the patent in suit.

18. The respondent asserts that these documents were made available to the public by being inserted in the packaging of the respective API test systems. The appellant contests this and argues that there is no evidence on file that this was so. Both parties accept that such API test systems were on sale before the priority date of the patent in suit.

The opposition division decided that documents D1, D2 and D4 were made available to the public before the priority date. Points 12 and 12.1 of the opposition division's decision state:

"12. The OD considers that there is prima facie no founded reason to doubt that the numbers printed at the bottom of the last pages of D1, D2 and D4, i.e. respectively 86, 89 and 1982 correspond to their date of printing.

12.1 It appears that the test systems relating to D1, D2 and D4 were well known in the art, a fact that has not been denied by P. Moreover, the OD considers that booklets containing the operating instructions of a test system (Instruction Manual) are indeed addressed to the users that had purchased said test system. In addition, other documents, the granted patent in particular [0006], give indications that the test systems disclosed in the booklets were freely available on the market. In the absence of proof of the contrary, the OD considered it reasonable to assume that D1, D2 and D4 which have been printed well before the priority date, have been made available to the public within this period and are therefore comprised in the state of the art in the sense of Article 54(2) EPC".

19. According to the established case law of the boards of appeal, when lack of novelty is alleged the burden of proof lies with the party claiming that the information in question was made available to the public, in this case with the respondent.

The case law of the boards of appeal has developed certain principles on the standard of proof necessary to establish the facts on which a decision is to be based.

In some decisions the boards of appeal have applied the standard of "the balance of probabilities", which means that in relation to, for example, the question of when a document was first made available to the public, the board must decide what is more likely than not to have happened (see for example decisions T 381/87, OJ EPO 1990, 213, T 296/93, OJ EPO 1995, 627, and T 729/91 of 21 November 1994).

In other decisions the boards judged that a fact on which a case against novelty was made had to be proved "beyond reasonable doubt" or "up to the hilt" (see for example decisions T 313/05 of 6 July 2006, T 782/92 of 22 June 1994, T 97/94, OJ EPO 1998, 467, T 848/94 of 3 June 1997, T 472/92, OJ EPO 1998, 161 and, in particular, T 750/94, OJ EPO 1998, 32).

20. Here a case of revocation of a granted European patent is at issue. To base a revocation decision on the mere balancing of probabilities of what might have occurred would be difficult to reconcile with the need for reliability in the decision-making procedures of the EPO, which is of utmost importance for users of the patent system as well as the general public. Thus, the public availability of documents D1, D2 or D4 before the priority date of the patent in suit can only be regarded as established if, in view of the evidence, the board has no reasonable doubt in this respect. Some doubts may be permitted as to whether the opposition division applied this approach. The opposition division stated in paragraph 13 of its decision: "In the absence of proof of the contrary, the OD considered it reasonable to assume that D1, D2 and D4 which have been printed well before the priority date, have been made available to the public...". The opposition's approach of shifting the evidential burden to the proprietor could only apply had further hard evidence been on file to support the public availability of these documents. However there is no such evidence before the board, neither was such evidence before the opposition division. Accordingly, there is no shift of the burden of proof on this issue.

21. The evidence on the public availability of documents D1, D2 and D4 is as follows:

- the numbers printed at the bottom of the last pages of each of documents D1, D2 and D4;

- the reference to various API test systems at paragraph [0006] of the patent in suit;

- the references to various API test systems in documents D7 to D10; and

- the declaration of Mrs Picon, including two annexes.

22. For the evaluation of the evidence it is at this point useful to recall that document D1 is the instruction manual for a "RAPIDEC ur" test system, D2 is the instruction manual for an "API 20E" test system, and D4 is the instruction manual for an "API 20B" test system. All of these test systems were manufactured by API System of France.

23. The respondent argued, and the opposition division accepted, that the numbers printed at the bottom of the last pages of each of documents D1, D2 and D4 were the dates of printing of these documents. These dates were all before the priority date. However, the actual date of printing of these documents is not material to the board reaching a decision on their public availability. What has to be proven is whether the printed documents ever reached the public domain.

24. Paragraph [0006] of the patent in suit refers to the fact that since the 1960s commercial bacterial identification kits have been available and lists the family specific kits sold by the IDS company, apparently under the reference "RapID" plus a suffix indicating the relevant bacterial family, and the family specific kits sold by the API System company, apparently under the reference "API 20" plus a letter indicating the relevant bacterial family. Paragraph [0006] specifically refers to the "API 20 E" test system that is the subject of document D2, that is referred to in document D8, and that is mentioned in Mrs Picon's declaration.

25. Document D7 refers to the use of a RAPIDEC ur test system produced by API System of France. Document D8 refers to the use of an API 20E system. Document D9 refers to the use of the API ZYM system, the API 20 B system and the API 20 NE system, all produced by API System S.A. of France. Document D10 refers to the use of an API 20 E system.

26. The declaration of Mrs Picon (document D6 in the appeal proceedings) states that she works for the subsidiary of the respondent that at one time was known as API System. Mrs Picon started working for API System in 1973. Mrs Picon states that she took part in the production and preparation of the "RAPIDEC ur" and "API 20 E" test systems. She states that the instruction manuals were included in the packages of the test systems that were to be sold. The annexes to the declaration appear to be check lists for enclosures for the packaging of a RAPIDEC ur and API 20 E test system. These check lists indicate that instruction manuals were included in such packaging, however, these check lists are not evidence that the particular systems to which they refer were in fact sold.

27. The above evidence suggests, and the appellant has not contested, that test systems bearing the names "RAPIDEC ur", "API 20 E" and "API 20 B" were on sale before the priority date of the patent in suit. What the respondent needs to prove beyond reasonable doubt is, however, that such a test system was accompanied by a document with the same contents as documents D1, D2 or D4. On this point the evidence put forward by the respondent is circumstantial and does not meet the high standard of proof required by the case law of the boards of appeal.

28. In the oral proceeding before the board the respondent argued that there was an overlap between the tests disclosed in document D7 and those disclosed in document D1, the inference being that document D1 was the instruction manual to which the authors of document D7 referred in order to carry out the tests that formed the subject of their article. Again this overlap between document D1 and document D7 does not provide a basis for concluding beyond reasonable doubt that a document with the same contents as document D1 was in the possession of the authors of document D7.

29. Hence, from the evidence on file it cannot be established with the necessary certainty that all or any of documents D1, D2 or D4 were made available to the public before the priority date of the patent in suit.

Novelty

30. In view of the findings above the documents cited contained in the state of the art pursuant to Article 54(2) EPC are documents D3, D5 and D7 to D10.

31. It has not been disputed by the respondent that none of these documents disclose a test system or related method which, as the test system and related method as subject-matter of claims 1 and 18, is capable of identifying a microorganism from groups of widely divergent microorganisms, comprising yeast and all of anaerobic bacteria, enteric bacteria, the gram positive group of bacteria, neisseria and Haemophilus and fastidious bacteria, i.e. which can identify microorganisms whatever indicated group it may belong to. In particular, by way of example it is noted that none of the above referred to documents disclose a test system and related method which is capable of identifying a microorganism from the group of fastidious bacteria.

32. In view of the above considerations the subject matter of the claims of the appellant's request are novel.

Remittal to the first instance for further prosecution

33. The patent is suit had been revoked by the opposition division on grounds of lack of compliance with the requirements of Articles 54 and 123 EPC, no examination having been made as to whether or not the claimed subject-matter, before the opposition division or as now formulated in the request before the board, involves an inventive step. In order to ensure that the parties have the opportunity of having the question of inventive step of the amended claims decided by the opposition division, with the possibility of a further appeal remaining open, the board considers it appropriate to make use of the power granted to it under Article 111(1) EPC to remit the case to the first instance for further examination.