T 2384/18 17-11-2022

1. The invention

The invention relates to a remote workstation for the control of percutaneous intervention devices provided at multiple remote lab units. The workstation comprises a control system, a graphical user interface, a measurement module and a selection device.

The control system is configured to remotely and independently control at least two percutaneous intervention devices, e.g. a guide wire and a working catheter. The graphical user interface is configured to display a set of icons representative of the operational status of the two percutaneous devices. The selection device enables the user to select the lab unit that the workstation is currently controlling.

The measurement module is configured to allow the user to measure the length of a structure (e.g. a vascular lesion) by measuring the distance moved by a controlled percutaneous device as it traverses the length of the structure (see Figure 7 of the patent specification reproduced below, the reference signs in parentheses corresponding to this embodiment). This is done by first aligning the distal tip (150) of the percutaneous device (guide wire 142) with the distal end (152) of the structure (lesion 140). The measurement module (66) is then activated by the user. The distal tip (150) is then withdrawn until it is aligned with the proximal end (154) of the structure (140). The user indicates this alignment and then the measurement module (66) calculates the distance that the percutaneous device (142) was withdrawn and displays it on a display device.

FORMULA/TABLE/GRAPHIC

Figure 7 of the patent specification.

2. Main request - Amendments

2.1 One percutaneous device in each lab unit

The control system in claim 1 is "configured to remotely and independently control at least two percutaneous intervention devices", without any indication in claim 1 that it is configured to simultaneously control the at least two devices. Hence, claim 1 encompasses also the sequential control of the two devices. Such sequential control by selecting which device to control each time is also described in paragraphs [0024], [0060] and [0075] of the application as filed and the corresponding passages of the granted description. There are thus no reasons to interpret claim 1 as limited to a system where the two controlled devices belong to the same currently controlled lab unit.

The selection of the "currently" controlled lab unit in the last feature of claim 1 does not imply that the at least two percutaneous intervention devices that the control system is configured to control must be provided in the same lab unit. Claim 1 encompasses for example a workstation which allows to currently control a lab unit with only one percutaneous device and to sequentially control a further lab unit with another percutaneous device.

It is undisputed that the application as filed does not disclose controlling a lab unit with a single percutaneous device but requires the at least two percutaneous devices to be provided in the same lab unit (see for example paragraph [0019] in view of paragraph [0034] as well as claims 28 and 31). Hence, claim 1 comprises subject-matter extending beyond the content of the application as filed.

2.2 It follows that the main request is not allowable because it contravenes Article 123(2) EPC.

3. Auxiliary request 1a - Admittance

Auxiliary request 1a was filed within the period specified by the Board in its invitation under Rule 100(2) EPC (point 5 of the communication dated 7 July 2022) and its claims address specifically the two issues highlighted in the Board's invitation. Its admittance into the proceedings is thus subject to Article 13(1) RPBA.

The amendment prima facie overcomes the issue of added subject-matter present in claim 1 of the main request by defining that the at least two percutaneous intervention devices are "of a selected lab unit (11) of the multiple remote lab units". The amendment prima facie does not give rise to new objections nor is it detrimental to procedural economy.

The appellant's argument that the respondent had already filed 7 auxiliary requests with its reply to the appeal is no valid reason in this case to not admit the new request. The Board notes in this regard that those auxiliary requests addressed inventive step objections which had been partly raised for the first time with the statement of grounds of appeal.

It is correct that claim 1 of auxiliary request 1a comprises amendments addressing both issues highlighted in the Board's invitation under Rule 100(2) EPC and not only the issue eventually found to be convincing. This cannot be used against the request's admittance but is rather a sign of the respondent's will to overcome the issues without unnecessarily increasing the number of requests.

The Board thus used its discretion under Article 13(1) RPBA to admit auxiliary request 1a.

4. Auxiliary request 1a - Amendments

4.1 The amendments to claim 1 of auxiliary request 1a as compared to claim 1 of the main request find support in paragraphs [0024], [0034], [0060] and [0066] of the application as filed.

4.2 The appellant did not raise any objection under Article 123 EPC to auxiliary request 1a. However, several of the appellant's objections to the main request are also applicable to auxiliary request 1a, so that it is appropriate to deal with them. The Board does not find any of the objections convincing for the reasons indicated below.

4.3 "Tip" instead of "distal tip"

Claim 1 refers interchangeably to the "tip" and the "distal tip" of the guide wire. It is clear when reading the claim in a technically sensible manner that both terms refer to the same entity, so that claim 1 is already directed to the "distal tip" and involves no generalisation in this regard.

4.4 "Structure" instead of "lesion"

Paragraph [0066] provides basis for the measurement module being configured to measure the length of a structure. The lesion in paragraph [0067] is a specific structure, and the features of the measurement module described in paragraph [0067] dealing with the tip's alignment are unrelated to whether the measured structure is a lesion or not.

4.5 "Withdraw" instead of "retract"

The Board regards both terms in the context of the invention as synonyms referring to pulling/drawing something back. Reading the term "withdrawing" in claim 1 as encompassing "pushing" goes against its generally accepted meaning and it is not the way the term would be construed by a person skilled in the art.

4.6 "Withdraw tip" instead of "retract guide wire"

The appellant argues by reference to Annex 2 submitted with the statement of grounds of appeal that the tip of the guide wire could be "withdrawn" by pushing the guide wire in case the guide wire was bent. The Board is of the opinion that in the hypothetical situation shown on Figure 2 of Annex 2 the tip would be moved in the proximal direction but it would not be withdrawn. Withdrawing the tip in the context of claim 1 means pulling it back.

4.7 Unallowable inclusion of a function module

Claim 1 requires the measurement module to be configured to allow the user to measure the structure's length, without defining that the measurement module is itself configured to align the tip.

Moreover, the objection raised by the appellant corresponds to an objection against claim 1 as granted but it is not applicable to claim 1 of the main request or of auxiliary request 1a, which recite that the module is to be activated by the user once the tip is aligned with the distal end of the structure. The alignment in claim 1 is thus not done by the - still inactive - measurement module.

4.8 Unallowable combination of two separate embodiments

Paragraph [0066] discloses "measuring the distanced [sic] moved by a percutaneous device as the percutaneous device traverses the length of the structure". This passage corresponds to the wording of claim 1 and thus provides basis for what the appellant refers to as "current distance measurement". Hence, paragraphs [0066]-[0067] disclose what the appellant refers to as "indirect guide wire retracting" combined with the current distance measurement. The support for the measuring method of claim 1 is provided in paragraphs [0066]-[0067], so that there is no unallowable combination with features from claim 41 as originally filed.

4.9 "Percutaneous device" instead of "guide wire"

In claim 1 of auxiliary request 1a, the percutaneous device used for measurement has been restricted to a guide wire, so that this objection to the main request is rendered moot by the amendments.

4.10 In summary, the amendments in auxiliary request 1a do not contravene Article 123(2) EPC.

5. Auxiliary request 1a - Inventive step

The appellant submitted that the subject-matter of claim 1 lacked an inventive step when starting from either of D5 or D2.

5.1 Starting from D5

5.1.1 D5 discloses a remote control catheterization system including a console (34) which can control several percutaneous intervention devices including a guide wire (see column 4, line 57 to column 5, line 15 as well as column 6, lines 41-46).

It is undisputed that D5 does not disclose at least:

(a) the features of claim 1 related to the measurement module

(b) a selection device to enable the user located at the workstation to select which lab unit [of the multiple remote lab units] the workstation is currently controlling (last feature of claim 1).

The groups of features (a) and (b) do not influence each other to interact synergistically. It is thus justified to assess inventive step using partial problems.

5.1.2 The Board has no reason to question the appellant's submission that the group (a) solved the technical problem of providing a further use for the remotely controlled catheter device and that the person skilled in the art would consult D2 faced with that problem.

The crucial issue in this case is whether D2 teaches a measurement module as defined in claim 1.

D2 deals with a device for measuring distances within a lumen, such as a guide wire for measuring the length of a stenosis. This is done in D2 by aligning a distal marker of the guide wire at an end of a lesion, repositioning the guide wire so that the distal marker is at the other end of the lesion, and determining the length of the lesion by measuring the extracorporeal movement of the guide wire (see column 2, lines 12-31).

The appellant's submission is directed specifically to the embodiments of Figures 7 and 8 of D2.

5.1.3 Embodiment of Figure 7 of D2

The embodiment of Figure 7 is described in column 4, lines 52-65. However, it is appropriate to have a broader look at D2 to understand the disclosure of this embodiment. Underlining has been added by the Board to some passages to emphasise certain aspects.

Starting on column 4, lines 18-22 it is described that the proximal portion of the guide wire (which extends out of the patient) is provided with ruler-like indicia to allow the operator to visually "detect how far the guide wire is axially moved with respect to a reference point such as the proximal end of an adapter 23". This enables noting the distances "L2" and "L3" shown when the guide wire's distal marker is positioned at the proximal and distal ends of the lesion. The lesion's length "L1" can then "be determined by subtracting the distance 'L2' from the distance 'L3' shown at the proximal portion" (see column 4, lines 39-42 referring to Figure 5).

The embodiment of Figure 6 uses a "wheeled distance measuring device 40 ... fixed with respect to a reference point, e.g. the adapter on the proximal end of a guiding catheter" (column 4, lines 43-47). The embodiment of Figure 7 uses this wheel 40 which "rotates when the guide wire 10 is moved to locate the radiopaque marker 21 at the ends 32 and 33 of the lesion 30". This rotational movement is related to the distance the guide wire moves and is sensed by a sensor. The sensor generates a signal representing the distance, signal which is transmitted to a display unit (column 4, lines 57-65).

The embodiment of Figure 7 is thus directed to transmitting to the display the distance that the guide wire has been moved, similarly as provided by the ruler-like indicia in the embodiment of Figure 5. It is then still up to the user to note the two distances displayed at each of the lesion's ends and to determine the lesion's length by subtracting both distances.

This is confirmed by other passages of D2. In the summary of the invention, the wheel is presented as an alternative to the ruler-like indicia to determine the distance traveled by the guide wire (column 2, lines 32-37 and 53-60). Column 2, line 63 to column 3, line 1 then states that "[t]hese distance measuring systems must be referenced to a suitable substrate, e.g. the adapter on the proximal end of the guiding catheter, so that the axial movement of the guidewire can be properly detected. To ensure that the distal position of the guidewire is not lost, it is preferred to ...", supporting that the distance/movement is measured with respect to a reference point, i.e. it is not a distance between two positions of the guide wire while in use. Also the independent method claims (see in particular steps c., e. and f. of claims 9 and 12) define a method comprising "noting" two positions and then determining the distance between both.

For these reasons, the embodiment of Figure 7 does not disclose that the measurement module "enables the user to indicate when the tip is aligned with the proximal end of the structure, and the measurement module is configured to calculate the distance that the guide wire was withdrawn as the measured length on the display device" as defined in claim 1. D2 teaches instead in the embodiments of Figure 7 displaying the distance traveled by the guide wire at each moment, i.e. its distance with respect to a predefined reference point, so that the operator can note the relevant distances and do the necessary calculations.

5.1.4 Embodiment of Figure 8 of D2

In the embodiment of Figure 8, the proximal shaft is provided with equally spaced surface disruptions. Light is emitted onto its surface and the reflected light is received by a sensor. The disturbance caused by the surface disruptions is detected as a series of peaks or valleys which can be counted and displayed as a distance (see column 4, line 66 to column 5, line 17).

Similarly as explained for the embodiment of Figure 7, also in this embodiment it would be up to the user to note the distances at each of the two relevant positions and to subtract the two distances to obtain the lesion's length. This is again confirmed by the reference to the electro-optical system in the same passage of the summary of the invention of D2 (see column 2, 60-66).

Hence, also the embodiment of Figure 8 does not disclose the features of claim 1 defining the measurement module quoted when discussing the embodiment of Figure 7 above.

5.1.5 When starting from the workstation of D5 and consulting the embodiments of Figures 7 or 8 of D2, the person skilled in the art would thus not provide the workstation with a measurement module as defined by claim 1.

The further references to either of D11 or common general knowledge in the inventive step objections starting from D5 address the second partial problem and are unrelated to the measurement module.

It follows that the objections of lack of inventive step starting from D5 are not convincing.

5.2 Starting from D2

5.2.1 The appellant submitted that the subject-matter of claim 1 was not inventive over D2 in combination with D5 and either of D11 or common general knowledge (as exemplified by D12 and D13).

D12 and D13 were submitted as examples of telemedicine devices for controlling multiple medical devices. D12 discloses on pages 6-8 remote patient monitoring but not any selective control of multiple remote devices. D13 discloses a mobile surgical facility which can be remotely operated. The appellant referred to D13 as a whole, but at first sight there is no disclosure of any selection of the specific surgical facility being remotely controlled. Hence, D12 and D13 do not prove common general knowledge supporting that it was obvious to select which lab unit to control from multiple lab units. The Board thus decided not to admit them under Article 12(4) RPBA 2007.

5.2.2 As indicated above for the objection starting from D5, D2 does not disclose a measurement module as required by claim 1. There are however further reasons why the objections of inventive step starting from D2 are not convincing.

5.2.3 First of all, it is questionable whether D2, which relates to a guide wire, could be a suitable starting point for arriving at a workstation for the remote control of percutaneous intervention devices provided at multiple lab units. In other words it is questionable whether the person skilled in the art without knowledge of the present invention would have tried to modify the guide wire of D2 to obtain such a workstation in an obvious way. Indeed, as explained hereafter, the objection formulated by the appellant is based on hindsight.

5.2.4 It is undisputed that D2 does not disclose at least the features of:

(a) a control system as defined by claim 1

(b) a graphical user interface as defined by claim 1

(c) a selection device as defined by claim 1

The appellant submitted that features (a) and (b) together solved the technical problem of improving control of the percutaneous device, while feature (c) solved the technical problem of improving efficiency of lab units.

5.2.5 When assessing inventive step using partial problems, the problems are to be determined in view of the technical effects achieved by the invention when compared with the starting point. The starting point is defined in this case by the device of Figs. 7 or 8 of D2.

This is not the approach underlying the appellant's submission. D2 deals with a guide wire facilitating the measurement of distances; it is thus directed to a single percutaneous device and its use. D2 does not disclose any kind of electronic or computer-aided control of the guide wire, let alone a workstation for the control of devices provided at multiple lab units. D2 does not deal with lab units either. This is why the technical problem allegedly solved by feature (c) of improving efficiency of lab units (or improving efficiency of the workstation as submitted by the respondent and supported by paragraph [0034] of the application as filed) could only become apparent once the teaching of documents D2 and D5 were combined.

The appellant is in fact applying the problem and solution approach twice in a sequential manner. The first time starting from D2 and the second time starting from the device obtained from combining D2 and D5.

This sequential approach does not reflect a stepwise improvement that the person skilled in the art was always wanting to make, as argued by the appellant. Instead, it goes well beyond the way that the problem and solution approach is to be applied when assessing inventive step. The sequential approach is an indicator of hindsight, with the problem including the lab units and thus an unallowable pointer to the solution. It also highlights, as submitted by the respondent, that at least features (a) and (c) interact with each. Both contribute to providing an efficient workstation for the remote control of percutaneous devices.

5.2.6 Hence, the objections of lack of inventive step starting from D2 are not convincing.

6. None of the appellant's objections prejudices maintenance of the patent on the basis of auxiliary request 1a.

The respondent provided a description adapted to the claims of auxiliary request 1a, in particular a new paragraph [0054] to replace the corresponding paragraph from the version which was found allowable by the appealed decision. The appellant had no objections to this amendment. The Board does not have any objections either.