1. Admission of the ground of opposition based on Article 83 EPC
1.1 Pursuant to Article 12(1), (2) RPBA, the ground of opposition based on Article 83 EPC is admitted into the appeal proceedings. The Board takes the view that the statement of grounds of appeal can not be read as being limited to Article 56 EPC.
1.2 The respondent (patent proprietor) is of the opinion that in the statement of grounds of appeal, the appellant (opponent) explicitly excluded the ground of insufficiency of disclosure under Article 83 EPC.
1.3 The board does not agree. Contrary to the respondent's (patent proprietor's) opinion the sentence in the statement of grounds of appeal that "it may be left aside whether the appealed decision has applied appropriate criteria when finding the amended patent to satisfy the sufficiency of disclosure requirement (A. 83 EPC) or not" cannot be understood as excluding Article 83 EPC from the appeal proceedings. Seen in the context of the whole paragraph it is clear that the main objection of the appellant (opponent) is that the opposition division allegedly did not apply the same level of competence to the skilled person in the reasoning under Article 83 EPC and under Article 56 EPC (points 15.4 and 21.3 of the impugned decision). The statement of grounds of appeal thus refers to both grounds.
1.4 Furthermore in point 1.a. of the statement of grounds of appeal, the appellant (opponent) obviously disagrees with the opposition division's findings under point 15.4 of the impugned decision:
Contrary to the opposition division's opinion that the exemplary disclosure of a one-way ratchet would be sufficient, the appellant (opponent) argues that such a one-way ratchet could not implement the function as described in paragraph [0016] of the patent in suit. This argument is substantiated at least by stating that "the one-way ratchet lacks any ability to switch" and that in an expelling operation, "the dial button will be dragged backward by the one-way ratchet", instead of being released from the scale drum.
Thus, as the statement of grounds of appeal includes substantiated arguments, the situation described in T 1488/08, referred to by the respondent (patent proprietor), in which no substantiation for some of the mentioned grounds for opposition was provided in the statement of grounds for appeal, does not apply to this case.
1.5 Hence, the ground of opposition under Article 83 EPC was invoked in the statement of grounds of appeal and is to be taken into consideration.
2. Sufficiency of disclosure
2.1 The patent in suit does not disclose the subject-matter of claim 1 of the main request in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.
2.2 It is noted that the board's conclusion is based on the statement of grounds of appeal and the appellant's (opponent's) explanations given during oral proceedings based thereupon. The appellant's (opponent's) submissions filed with letter dated 16 August 2022 were not taken into consideration.
2.3 Claim 1 of the main request incorporates the features of granted claim 7 that requires that "the dose dial button (10) is releasable coupled to scale drum (20)" (feature 1.13). Granted claim 7 was objected under Article 83 EPC during opposition proceedings and dealt with in the contested decision under point 15.4. The respondent (patent proprietor) agreed with the opposition division that the concept of a releasable coupling was well known in the art and that the exemplary disclosure of a one-way ratchet (paragraph [0016]) was sufficient to enable a skilled person to put the invention into practice.
2.4 The board does not agree for the following reasons.
2.4.1 The releasable coupling is only mentioned in paragraphs [0016] and [0031] of the patent in suit. Paragraph [0031] of the patent in suit discloses that "The connection between the dial button 10 and the scale drum 20 can be made through a releasable coupling such that when the set dose is injected, the dial button 10 does not necessarily rotate back with the scale drum 20.". In the context of a dial button that does not rotate back with the scale drum during dose injection, paragraph [0016] discloses that "in one embodiment this coupling can be made such that they [the scale drum and the dial button] only rotate together when a dose is set where after the dose dial button remains in its position when the scale drum rotate back to its initial position. Such coupling could be any kind of one-way ratchet mechanism which allows the scale drum to rotate in one direction independently of the dose dial button."
2.4.2 It is undisputed by the parties that to implement a one-way ratchet in such a manner that the dial button 10 does not rotate back with the scale drum 20 during dose injection, at least one of the cooperating components of a one-way ratchet has to be axially moved to get disengaged from the other component of the one-way ratchet.
2.4.3 The respondent's (patent proprietor's) argumentation that a skilled person reading the disclosure of the patent would understand that such an axial movement would be necessary and that they would obviously find means to implement it, e.g. by providing a separate connector and an additional lever for moving the connector in and out of engagement, is not convincing.
2.4.4 The only hint in the patent about how to realize feature 1.13 is by means of any kind of one-way ratchet mechanism (paragraph [0016]). However this general disclosure of a releasable coupling does not specify how the desired functionality might be obtained, in particular as neither the dial button nor the scale drum moves axially (paragraph [0010] of the patent in suit). As brought forward by the appellant (opponent), there is no inherent releasable coupling in the sense of an axial disengagement in a one-way ratchet mechanism. Additionally, the patent in suit does not comprise any instruction regarding the provision of a releasable coupling with the intended function in combination with a one-way ratchet. Neither an additional connector nor any kind of lever is mentioned.
2.4.5 Therefore the skilled person, armed with the disclosure of the patent and common general knowledge, is not in a position to configure without undue burden an injection device comprising the feature 1.13 of claim 1 of the main request, i.e. a device in which the dose dial button does not rotate back with the scale drum 20 during dose injection by means of a releasable coupling between it and the scale drum.
3. Admission of auxiliary request I
3.1 The Board admitted into the appeal proceedings auxiliary request I, filed during oral proceedings before the board.
3.2 Article 13(2) RPBA 2020 applies. While in principle, any amendment to a party's appeal case made after notification of a summons to oral proceedings shall not be taken into account, the Board takes the view that there are exceptional circumstances in the present case which justify the admission of the auxiliary request I.
3.3 In the statement of grounds of appeal some aspects why a one-way ratchet would not be suitable as a releasable coupling, were raised but worded in such a manner that their intended meaning only became fully clear with the explanations given by the appellant (opponent) during oral proceedings. In particular the meaning of the argument that a "one-way ratchet lacks any ability to switch" and the necessity of such a "switching" function to prevent that "in an expelling operation, [...], the dial button will be dragged backwards by the one-way ratchet" (see point 1.a. of the statement of grounds of appeal) was fully clarified only during oral proceedings before the board.
3.4 Accordingly, it is fair to say that the respondent (patent proprietor) only became fully aware of the arguments of the appellant (opponent) at the oral proceedings. Under these exceptional circumstances, the Board takes the view that the respondent (patent proprietor) should be given a possibility to react by submitting the new auxiliary request I during oral proceedings.
3.5 Furthermore auxiliary request I is based on auxiliary request IV, filed for the first time during oral proceedings before the opposition division. Even if its admissibility was not decided upon in the first instance proceedings, it was maintained by the respondent (patent proprietor) by filing it again as auxiliary request II with the statement of grounds of appeal. Claim 1 of auxiliary request I filed during oral proceedings differs from claim 1 of the main request essentially by the deletion of feature 1.13 and by the additional amendments made in accordance with auxiliary request II. The latter amendments were thus not surprising for the appellant (opponent).
4. Reformatio in peius
4.1 The appellant (opponent) submitted that the deletion of feature 1.13 in claim 1 of the auxiliary request I was not allowable in view of the prohibition of the reformatio in peius.
4.2 By deleting feature 1.13, claim 1 no longer requires a releasable coupling between the dial button and the scale drum as in claim 1 maintained by the opposition division.
4.3 It is noted that the amendment is within the limits of Article 123(3) EPC as the deleted feature 1.13 was added only in opposition proceedings.
4.4 In principle, an amended claim, which would put the opponent and sole appellant in a worse situation than if it had not appealed, must be rejected. However, G 1/99 (see headnote) allows an exception to this principle in order to meet an objection put forward by the opponent/appellant during the appeal proceedings, in circumstances where the patent as maintained in amended form would otherwise have to be revoked as a direct consequence of an inadmissible amendment held allowable by the opposition division in its interlocutory decision.
4.5 In the present case, it is undisputedly not possible to restrict feature 1.13 by introducing one or more originally disclosed limiting features in order to overcome the lack of sufficient disclosure. The board thus takes the view that the deletion of feature 1.13 is the only possibility for the respondent (proprietor) to overcome the deficiency due to the amendment introduced into the version of the patent as maintained by the opposition division but which does not comply with the requirements of the EPC (see G 1/99, point 15).
4.6 Hence the Board considers the amendment made in accordance with auxiliary request I is appropriate and necessary even if, as a result, the situation of the appellant (opponent) is worsened.
5. Remittal
5.1 According to Article 11, first sentence, RPBA 2020, the board remits the case for further prosecution as special reasons present themselves for doing so.
5.2 The opposition division maintained the patent in amended form according to the main request underlying this decision. The reasoning for the maintenance of the patent was based on feature 1.13 added to granted claim 1 during opposition proceedings.
5.3 Feature 1.13 is no longer present in claim 1 of auxiliary request I and the latter is further amended by introducing other features.
5.4 This leads to a substantially different situation as compared to the one underlying the decision under appeal.
5.5 Moreover, the remittal was requested by the appellant (opponent) and not objected to by the respondent (patent proprietor).
5.6 Under these circumstances, the Board considers that there are special reasons in the sense of Article 11 RPBA for remitting the case to the opposition division.
6. Third party observations (Article 115 EPC)
In view of the above, and considering that the third party's observations only deal with the issue of inventive step of the subject-matter of claim 1 as maintained by the opposition division, they are irrelevant to the present decision such that there is no need to discuss them.
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