EP 3 752 838 B1 relates to a method for determining the total histamine degradation capacity in biological samples
Original Fig. 6
Brief outline the case
During examination the ED has apparently considered that the complete removal of the y-axis label “Absolute histamine degradation capacity [%]” in the original Figure 6 complied with the requirements of Art123(2) and R 139.
The OD agreed with the ED and rejected the opposition. The opponent appealed.
During the OP before the board, first were discussed the patent as granted (as well as AR1-4). The board held that removal of the y-axis label in Fig.6 infringed Art 123(2).
The proprietor then filed corresponding requests in which Fig. 6 was amended. The original requests were then withdrawn and a new MR was filed, as well corresponding requests in which either Fig 6 was amended or deleted. Those requests were not admitted under Art 13(2) RPBA.
The proprietor’s request to enlarge the board and an objection under R 106 were dismissed.
The patent was thus revoked.
We will concentrate on the removal of the y-axis label in Fig 6.
The OD’s decision
There would be no doubt that it would be immediately apparent to a skilled person that the axis labelling in Figure 6 of the application as filed was incorrect.
Furthermore, in the opinion of the OD, it was immediately apparent to a skilled person what correction should be made, namely deletion without replacement.
This is because the description relative to Fig 6, page 19, line 36 – page 20, line 10, already indicates that a correct diagnosis of a suspected HIT condition is represented by a percentage specificity. The remaining percentage figure thus corresponds to the correct correction. It is not necessary to spell out in Figure 6 what this percentage represents, as the relevant passage in the description mentioned above already provides this information. The OD further found that the parts of the application relevant to Figure 6, as filed, were not contradictory.
The proprietor’s point of view
The proprietor did not argue that the correction of an obvious error constituted grounds under Art 123(2), but essentially contended that the deletion of the ordinate label in Figure 6 of the patent during the grant procedure had not altered the claimed method. Nor, it argued, had any new technical teaching been introduced.
Taking into account the disclosure of the originally filed application in its entirety, as a skilled person would understand by drawing on CGK, that it was beyond doubt that Figure 6 depicts the “percentage specificity of the method according to the invention in comparison with clinical practice”.
The proprietor argued that it was initially unclear which technical teaching outside the original disclosure was being challenged as an inadmissible extension. According to T 1269/06, it was in fact incumbent on the opponent to set out which technical teaching had not been originally disclosed. The subject-matter of the original application was its technical teaching, in this case a chemical detection method with defined procedural steps.
Referring to the original description, pages 1 to 3, the proprietor explained the technical background and the methods referred to in Figure 6 in the prior art.
The opponent’s point of view
The opponent argued that in diagnostic procedures, a distinction is made between specificity and sensitivity as separate values. There is no combined value or layman’s description. No distinction is made in the description of the figures. The percentage figures make no sense in the context of diagnostics. The original axis label, namely “percentage of total histamine degradation capacity”, was not unreasonable in itself, but would portray the THAK test as unreliable.
In any event, the amendment concerned the subject-matter of the invention within the meaning of Art 123(2), as the content of Figure 6 was relevant to IS and was relied upon by the proprietor.
A change to Figure 6 did therefore relate to the subject-matter of the invention and was not allowable under Art 123(2). The proprietor itself had conceded in its submissions that the values in Figure 6 made sense following the deletion, whilst the figure had been misleading due to the original axis labelling. The subject-matter of the invention was therefore clearly affected.
The board’s decision
From the minutes of the OP before the board, it appears that the board pointed out that, in accordance with G 3/89, Reasons 1.3 and 1.6, Art 123(2) does not distinguish between amendments by way of correction and other amendments, and also covers the former.
A correction under Rule 139 EPC thus constitutes a special case of an amendment under Art 123(2), and any infringement of the prohibition of added matter under Art 123(2) constitutes grounds for opposition under Art 100(c). An amendment made during the examination phase under R 139 EPC could therefore be reviewed in opposition or opposition appeal proceedings; see also decisions T 0965/21 and T 0117/19.
Following deliberation, the chairman informed the parties of the board’s view that the main claim did not satisfy the requirements of Art 100(c).
In the Board’s preliminary view, the objections under Art 100(c) EPC raised in respect of the main claim would also apply to auxiliary claims 1 to 4.
In response to the proprietor’s question as to what technical teaching had been added, the chairman replied that, first of all, the conditions for a correction had not been met. As a result of the correction to the axis labelling, ambiguous interpretations of Figure 6 were possible, some of which were also contradictory. This gave rise to two problems. The correction thus led to an inadmissible extension.
Comments
In view of the withdrawal of the original requests and the filing of new requests which were not admitted under Art 13(2) RPBA, we will not really know what were the two problems mentioned by the board.
One thing is nevertheless clear, merely removing the y-axis label in a figure may introduce added matter.
The amendment to Fig 6 was introduced in reply to observations of a third party, the later opponent. In the reply to those, the proprietor explained that in Figure 6, the y-axis label has been removed, as it was in fact incorrect. It is not the “absolute histamine degradation capacity” that is shown, but rather the percentage diagnostic allocation (sensitivity and specificity) of the relevant diagnostic test systems within the patient cohorts depicted.
In a further observation of a third party, the later opponent, the latter made clear that “It is not possible to correct Fig. 6 by changing the description of the abscissa.” The ED nevertheless proceeded to grant.
The amendments carried out on Fig 6 were thus suspect from the day of the amendment.
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