T 0485/11 - Identification code: technical

Key points

• Claim 1 is directed to a method for data management in an analytical laboratory. The distinguishing feature at issue is that an identification code is placed on a container at the time of production or packaging of said container, and not thereafter. The opposition division took the view that the labelling of a sample container at the stage of production or packaging was merely an administrative measure devoid of any technical aspects and should thus not be taken into consideration in assessing inventive step. The Board however finds that this feature is "a technical feature solving the technical problem of avoiding label misplacement with respect to the kind of container to be used for a given type of analysis". The Board acknowledges inventive step.

EPO T 0485/11 - link

IX. Claim 1 of the main request reads as follows:

"A method for data management in an analytical laboratory,
comprising the steps of:
- providing a plurality of containers for the laboratory analysis of biological specimens, each container being associated with a unique identification
code, placed on the container at the time of the production or packaging thereof;
- by means of a central computer, associating a patient code with a patient to be subjected to analysis;
- for each container used for said patient, generating in a data processing system a combination of said patient code and said identification code of
the corresponding container;
- carrying out, by means of at least one analyzer, at least one analysis on the container or containers used for said patient, the analyzer entering the
results of said analysis, combined with the identification code of the container or containers, into the data processing system,
wherein said identification code contains additional data relating to the type of analysis for which said container is intended, and wherein the analyzer
receiving a container reads the identification code and checks that the type of analysis for which the container is intended corresponds to the analysis which
the analyzer is to carry out."

Reasons for the Decision

1. The appeal is admissible.

2. Main request - Article 56 EPC

2.1 It was common ground in the written and oral submissions of both the appellant and the respondent that E1 represents the closest prior art to the subject-matter of the granted claims. Both parties also agreed that, as stated in the decision under appeal, the subject-matter of claim 1 differs in substance from the disclosure of E1 in that:

1) the identification code is placed on each container at the time of production or packaging of said container,

2) said identification code is composed of two fields,

3) the first field represents an identifier of the container and the second field represents additional data relating to the type of analysis for which said container is intended, said data being read by an analyser receiving said container to check that the type of analysis for which the container is intended corresponds to the analysis which the analyser is to carry out.

2.2 Technical character of feature 1)

The opposition division took the view that the labelling of a sample container at the stage of production or packaging was merely an administrative measure devoid of any technical aspects and should thus not be taken into consideration in assessing inventive step, because this feature did not solve the technical problem of avoiding label misplacement. The respondent also challenged the technical character of feature 1) since it was irrelevant when the identification code was applied to the container as long as it was applied before it was filled with the biological material that was to be analysed.

The board however notes that, since the identification code contains data relating to the type of analysis for which the container is intended, placing it at the time of production or packaging can prevent a medical operator at the time of use from choosing a container which could be inappropriate for the intended analysis of a patient sample. Therefore, at least for this reason, feature 1) can be considered as a technical feature solving the technical problem of avoiding label misplacement with respect to the kind of container to be used for a given type of analysis. The appellant has also plausibly argued that placing a unique code on a container at the time of production may prevent the same identification code from being assigned to two different containers due to a failure in the medical laboratory information system or an error by a medical operator. Further, the appellant has stressed that having a unique identification code from the time of production enables containers to be uniquely identifiable on a large geographical basis and not solely within a single medical laboratory.

For these reasons, the board judges that feature 1) has technical character in the context of the application.

2.3 Prior art

[]

2.4 The technical effects of the distinguishing features of claim 1 identified in point 2.1 with respect to E1 as closest prior art are that:

- the container identification code is unique to each container and not defined by the laboratory information system,

- the type of analysis for which the container is intended may be checked by the analyser as well as by the medical operator who selected the container.

It was common ground during the oral proceedings that there is no synergistic effect between the distinguishing features of claim 1 relating on the one hand to the uniqueness of the identification code placed at the time of production, leading to the first technical effect, and on the other hand to the indication of the type of analysis contained in the identification code, leading to the second technical effect. Therefore, two partial technical problems can be formulated:

- how to generate a unique patient/container association which has high reliability,

- and how to avoid performing a wrong analysis on the content of a given container.

The respondent has argued, and the board agrees, that E4 addresses the first partial problem (see page 1, lines 22 to 24 and page 3, lines 1 to 3) and discloses the same solution as claim 1, i.e. placing a unique identification code on the container at the time of production (see page 3, lines 4 to 14, page 4, lines 14 to 19 and page 7, lines 4 to 6). Therefore, the feature of placing a unique identification code at the time of production of the container cannot contribute to inventive step of the subject-matter of claim 1.

As to the second partial problem, the respondent has presented two alternative lines of argumentation, one based on E1 alone, the other based on a combination of E1 with E2.

First, according to the respondent, document E1 itself discloses at column 14, lines 15 to 23 a check of the type of analysis ("tests to be performed") by the analyser, based on a combined patient's identity/container's identity code ("bulk quantity identity"). Further, the passage at column 3, lines 33 to 37 teaches that the code could be placed on the container before the sample is put inside. The board however is not convinced by these argument since the "tests to be performed" mentioned in E1 do not simply represent a type of analysis in the sense of claim 1. In E1, it is the medical operator which decides to use a particular container for a particular type of analysis, and the labelling of the container with an identification code indicating the type of analysis to be performed reflects the choice of the medical operator in that respect, not the type of analysis for which the container is intended. The skilled person would thus not find in E1 a solution as defined in claim 1 for solving the second partial problem.

Secondly, the respondent has pointed out that the passages from page 3, line 27 to page 4, line 1, from page 8, line 24 to page 9, line 2 and from page 9, line 27 to page 10, line 2 in E2 indicate that the analyser checks which test is to be performed based on a bar-code label previously placed on the container. The respondent then argued that the skilled person would find in these passages of E2 a hint to code the type of analysis at the time of production of the container. However, in the board's view there is no disclosure in E2 that the bar-code label is placed at the time of production or packaging of the container. More importantly, the whole disclosure of E2 (see in particular page 2, lines 7 to 10, page 6, lines 1 to 3, page 15, lines 18 to 21, page 18, lines 22 to 26, claim 7) is directed to the manufacturing of containers suitable for labelling by the user, i.e. the medical operator, using standard bar-code labels. The mere fact that a bar-code label identifies both the test sample and the test to be performed shows that it is issued when the container is used, not when it is produced. Therefore, a combination of E1 and E2 would not lead the skilled person to the solution of claim 1 for the second partial technical problem.

Thus, the board judges that the subject-matter of claim 1 as granted, and of corresponding independent system claim 12, involves an inventive step having regard to the disclosure of E1, E2 and E4.

3. Since the appellant's main request is allowable, there is no need for the board to consider the appellant's auxiliary request.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is maintained unamended.