T 0950/16 25-09-2020

1. Novelty

1.1 Document D14 undisputedly discloses:

(M1.1) A medical device system, including:

(M1.2) a delivery system (for endoluminal devices, paragraph [0001]) comprising a housing ("casing", paragraph [0013]; 502 in Figure 5, paragraph [0053]) disposed external to a subject (in view of the hand-operated elements in Figures 2 and 5),

(M1.3) wherein the housing comprises an actuator (e.g. handle 122, slide 46 (Figure 2B), dial 48 or crank 49 (Figures 3A and 3B); paragraph [0039]).

1.2 D14 further discloses two delivery system components (outer sheath 28 and pusher 27) connected to respective racks (34, 36) linked by pinions (38, 39) to be simultaneously movable (Figures 2A-2C). Undisputedly, such a movement is not independent.

However, D14 further discloses two mechanisms to temporarily disengage the linkage between the racks and pinions. This renders both components mutually independently movable.

1.2.1 Figure 5 discloses a "clutch mechanism" to "push both pinions out of engagement with the racks" (paragraph [0053]). Claim 49 relates to this clutch mechanism and discloses "a second member movable to engage one or more of the pinions". However, contrary to the appellant's submission, claim 49 further describes that the second member acts to "disengage the pinions [plural] from the racks". Hence, claim 49 does not disclose an independent disengagement of only one of the pinions. Therefore, the clutch mechanism of Figure 5 discloses that either both or none of the pinions is engaged with the racks.

1.2.2 Figure 6 discloses a "lag system" in which rack 634 of the sheath is provided with a portion (602) without teeth to prevent the linkage between the two delivery system components. D14 explicitly discloses in paragraph [0055] referring to Figure 6 that, "when rack 634 attached to outer sheath 28 is retracted over portion 602, [...] neither pinion 39 or 38 rotate", so that the pusher remains stationary.

1.2.3 Accordingly, in both embodiments of Figures 5 and 6, the delivery system of D14 is configured and arranged such that the actuator (handle 122, Figure 2B) is adapted to move a first delivery system component (outer sheath 28) independently of a second delivery system component (pusher 27), thus disclosing feature M1.4.

1.3 It is correct that, in both embodiments, at the same time the second component (pusher 27) is also movable independently of the first component (outer sheath 28). However, feature M1.5 does not only require an independent movement of both components but also that these independent movements are executable by "the [same] actuator".

In fact, none of the actuators in D14 is adapted to move both components mutually independently of each other when the linkage between the racks is disabled. Handle 122 and slider 46 (Figure 2B), which are attached to one of the racks, respectively, can only move the component attached to the respective rack. Dial 48 and crank 49 can only move the component whose rack is engaged with the pinions. According to Figure 5, where both pinions are disengaged from both racks, the dial and crank cannot move any of the components. In the embodiment of Figure 6, they can only actuate the pusher.

1.4 The embodiments of Figures 5 and 6 are presented as separate alternatives in D14 (see, for example, paragraphs [0015] and [0056]). They are thus not directly and unambiguously disclosed in combination. However, for the same reasons as in 1.3, not even a combination of the mechanisms of Figures 5 and 6 would disclose the same actuator adapted to move both components independently.

1.5 Accordingly, the invention defined in claim 1 is novel over the delivery system of document D14.

2. Inventive step

2.1 The subject-matter of claim 1 differs from the delivery system of Figure 6 of D14 by feature M1.5. This feature does not only foresee a movement of the second delivery system independently of the first but also that one and the same actuator is adapted to move the first and second delivery system components independently of each other.

2.2 This difference solves the problem of simplifying the actuation of the deployment procedure (see [0004] of the patent in suit).

2.3 D14 does not disclose the solution of using the same actuator for different independent movements (see point 1.3 above). It is thus not apparent how D14 could have led the skilled person to the subject-matter of claim 1.

2.4 The appellant suggests that the skilled person while adapting the delivery system to different implants and their specific deployment procedures would have modified the embodiment of Figure 6 by providing a further portion without teeth on rack 36 connected with the pusher. In this way, the dial 48 or crank 49 shown in Figures 3A and 3B would be adapted to actuate movement of the outer sheath 28 and of the pusher 27 independently of each other.

However, the appellant failed to submit which specific implant or deployment procedure would have required or prompted the proposed modification. It is, however, considered that the skilled person would only have undertaken a particular modification based on a specific motivation.

In addition, the proposed modification would have led to a mechanism that did not work properly. While the dial or crank are in theory adapted to move the components independently, when the pinions are engaged with the respective rack, there is no mechanism that brings the racks back into engagement with the pinions once disengaged at a toothless portion of the rack. A further actuator would thus be needed for pulling the racks back into engagement with the pinions and switching between the independent movements. As this is not seen as an improvement but rather as a complication of the actuation, the skilled person would not have considered the proposed modification as a proper solution for adapting the delivery system to a specific deployment procedure.

The skilled person would therefore not have modified the lag mechanism of Figure 6 in the way submitted by the appellant.

2.5 Accordingly, document D14 neither discloses nor suggests the distinguishing feature M1.5 and, starting from this document, the invention of claim 1 thus involves an inventive step.

3. Admittance of documents E1-E6

3.1 Documents E1-E6 were submitted with the appellant's letter of 24 August 2020, only about one month before the date of the oral proceedings.

3.2 Applicable provision of the RPBA

According to the transitional provisions of Article 25(3) RPBA 2020, Article 13 RPBA 2007 is applicable instead of Article 13(2) RPBA 2020 "where the summons to oral proceedings [...] has been notified before the date of the entry into force" of the revised version of the RPBA.

3.2.1 In the case at hand, a first summons to oral proceedings, issued on 16 December 2019, was notified before entry into force of the revised version of the RPBA. However, following a request for postponement, the oral proceedings were cancelled, and a new summons was issued on 7 February 2020.

The Board thus had to establish which of the summonses qualified as "the summons" in Article 25(3) RPBA 2020, to determine whether Article 13(2) RPBA 2020 or Article 13 RPBA 2007 is applicable with respect to the admittance of late filed documents E1-E6. The parties did not wish to comment on this point.

3.2.2 According to the "Explanatory remarks" on Article 25(1) RPBA 2020 (OJ EPO 2020, supplementary publication 2, page 71), the transitional provisions of Article 25 RPBA 2020 intend to protect the "legitimate expectations which parties may have had at the time of filing" their submissions. Indeed, the reasons for a further summons are diverse and not in every case caused by the parties. It would thus be undue to make the applicability of the law dependent on the date of a later summons.

Hence, in the current case, the admittance of documents E1-E6 is not subject to the criteria of Article 13(2) RPBA 2020 but is governed by Article 13 RPBA 2007.

3.3 In exercise of the discretion granted by Article 114(2) EPC and 13(3) RPBA 2007, the Board decided not to admit documents E1-E6 into the proceedings.

The appellant's justifications for the late submission of these documents, namely that these documents were identified from the opposition proceedings against a family member of the patent only after a change of representative in this case, does not excuse their lateness. In addition, as the notice of opposition in the parallel case had been filed in February 2020 and the change of representative took place in May 2020, the reasons given cannot explain the documents being submitted as late as 24 August 2020.

The alleged prima facie high relevance of E2 for the novelty of the subject-matter of claim 1 could not be established.

Figure 12 of E2 shows a rotary actuator (1206) connected to a drum with two guide grooves (1212, 1214). Upon rotation, the pitch of the rotating guide grooves is converted into an axial movement of respective transmission elements (1216, 1218) engaged within the grooves and further transmitted to distal delivery system components. Sections without pitch in one of the grooves would mean that one component remained stationary while the other was moved, i.e. an independent movement of the two components. However, the exact orientation of the guide grooves, in particular a purely vertical, zero pitch alignment, is not unambiguously derivable from the schematic figure. In fact, the middle section of groove 1214 rather appears to be slightly inclined.

From documents E1, E3-E6 and the written submission of 24 August 2020, the Board could also not prima facie

recognise a disclosure of the same actuator adapted to move different delivery system components mutually independently from each other, and the appellant did not wish to further elaborate on this point at the oral proceedings.

E1-E6 are thus not considered to be prima facie highly relevant for the assessment of novelty of the subject-matter of claim 1.

For these reasons, documents E1-E6 are not admitted into the proceedings.

4. In summary, none of the grounds of opposition under Article 100 EPC submitted by the appellant prejudices the maintenance of the patent as granted.