T 0031/84 (Test device) of 4.5.1985

Summary of Facts and Submissions

I. European patent application No. 80 102 614.7, which had been filed on 12.05.80, claiming USA priority of 21.05.79, was granted as European patent No. 19 253 on 12.05.82, with nine claims. Claim 1 reads : "An enzymatic method for determining the amount of tri glycerides present in an aqueous fluid by hydrolysis of the triglycerides and then by determination of the amount of triglycerides present based on the amount of glycerol produced, characterised in contacting the fluid with a mixture of a lipase and cholesterol esterase for a time sufficient to hydrolyze the triglyceride to glycerol and free fatty acids."

II. On 11.02.83, the Opponents (Respondents) lodged opposition against the patent granted, requesting complete revocation thereof, for lack of novelty and inventive step, based on the following documents : (1) Biochim. Biophys. Acta 231 (1971), 15-22; ... (3) DE-C-2 229 849; (5) DE-C-2 315 501; ...

III. By a decision of 01.12.83, the Opposition Division revoked the patent. It considered the invention claimed in Claim 1 novel because, in its view, none of the citations described the use of a mixture of lipase and cholesterol esterase for a triglyceride determination. However, it held that Claim 1 lacked inventive step, because it was known from citation (5), dealing with cholesterol determination, that Candida cylindracea, widely used in industry for its lipase activity, contains not only a lipase, but also a cholesterol esterase. Having thus learned that it is such an enzyme mixture which makes this micro-organism so useful, it would be obvious for the expert to use such a mixture for triglyceride determination. ...

IV. A notice of appeal was filed by the Appellants against the decision of the Opposition Division on 26.01.84. The fee for appeal was paid. The Statement of Grounds for appeal submitted on 31.03.84 argued essentially as follows: Citation (5) relates to a cholesterol assay only, without suggesting use of its techniques for a triglyceride assay. It is to be emphasized that this citation does not disclose any additive or synergistic effect of the two enzymes contained in C. cylindracea. In response to a communication from this Board suggesting that, as proven by (5), citation (1) would appear to destroy the novelty of the patent, the Appellants contend that (1) teaches nothing concerning triglyceride assays; does not mention involvement of cholesterol esterase, but suggests presence of an isomerase; and is absolutely worthless to an expert for providing a rapid and economical method of triglyceride determination.

The Respondents have contested the Appellants' arguments. They have pointed out that (1), as evidenced by the first paragraph of section "Quantitative Determination of Esters and Acids", describes quantitative colorimetric determination of glycerol liberated by enzymatic hydrolysis of triglycerides, utilizing as an enzyme the trade product "Lipase MY", which is explicitly referred to as unpurified (page 16, section "Lipase Sources") and must therefore have contained cholesterol esterase. Citation (5) utilizes the same "Lipase MY". ...

VI. In the Oral Proceedings of 04.06.85, the Appellants have submitted a fresh set of Claims 1 to 7. New Claim 1 reads as follows: :.p. "An enzymatic method for determining the amount of tri glycerides present in an aqueous fluid by hydrolysis of the triglycerides and then by determination of the amount of triglycerides present based on the amount of glycerol produced characterised in contacting the fluid with a mixture of a lipase and cholesterol esterase for a time sufficient to hydrolyze the triglyceride to glycerol and free fatty acids, wherein the lipase is produced from a microorganism selected from the group consisting of Rhizopus delemar, Rhizopus arrhizus and Chromobacterium viscosum and the cholesterol esterase is obtained from the microorganism Pseudomonas aeruginosa or from beef pancreas, and 0,01 to 5 U cholesterol esterase per 10 U lipase are present." The Appellants (Patentees) request that the decision under appeal be set aside and the patent be maintained in an amended form on the basis of the new claims.

The Respondents, in turn, request dismissal of the appeal.

Reasons for the Decision

1. The appeal is in accordance with Articles 106 to 108 and Rule 64 EPC; it is thus admissible.

2. There can be no formal objection to the new claims, because they do not extend the scope of the patent as granted (Art. 123, para. 3, EPC). ...

3. While Claim 1 as granted could be considered to have been anticipated by citation (1), as proven by citation (5), it is undisputed, and thus requires no lengthy explanations, that new Claim 1 does possess novelty : the combination of lipase from one of the three sources mentioned therein, with cholesterol esterase of one of the two sources set forth in the new Claim 1, has not been disclosed by any of the cited documents, nor has the ratio of cholesterol esterase to lipase defined in the new Claim 1 been so disclosed.

4. Final conclusions as to inventive step are not possible without further substantive examination and, perhaps evidence. ...

ORDER

For these reasons, it is decided that :

1. The Decision of the Opposition Division is set aside.

2. The case is remitted to the Opposition Division for further substantive examination on the basis of Claims 1 to 7 and description as submitted during the Oral Proceedings.