T 2292/14 02-03-2016

1. The appeal is admissible.

2. The invention

The invention as defined in claim 1 of all requests concerns a dialysis system.

According to the description it may relate specifically to automated peritoneal dialysis (APD).

Together with hemodialysis, peritoneal dialysis is a commonly employed therapy to treat loss of kidney function (paragraph [0004]). Peritoneal dialysis utilises a dialysate which is infused via an implanted catheter and then left dwelling in the patient's peritoneal cavity for a certain period of time. There, the dialysate contacts the peritoneal membrane, through which waste, toxins and water from the bloodstream are transferred to the dialysate due to diffusion and osmosis. After the dwelling time the spent dialysate together with the substances transferred to it are drained from the peritoneal cavity and disposed of (paragraph [0005]).

Automated peritoneal dialysis (APD) is a particular kind of peritoneal dialysis in which a dialysis machine automatically performs several drain, fill and dwell cycles overnight, while the patient sleeps. A "last fill" is typically performed at the end of the treatment, such that, when the patient disconnects from the dialysis machine, the dialysate remains in the peritoneal cavity during the day (paragraphs [0008] to [0010]). Automated peritoneal dialysis (APD) is a convenient treatment for the patient who does not have to go to hospital regularly for hemodialysis and does not need to perform the drain, fill and dwell steps manually.

According to the invention, the dialysis system comprises a display device and a controller with software that makes the display device display a plurality of set-up screens requiring an input by a user in order for the user to proceed through those set-up screens, after set-up display a plurality of treatment screens that do not require an input by the user and, after therapy, display a plurality of disconnection screens requiring an input by a user in order for the user to proceed through those disconnection screens.

As a result, a simplified APD system could be provided, which is ergonomically improved and hence easier for the patient to use and operate (paragraph [0011]).

The parts of the patent as granted which are most relevant for the illustration of the claimed invention are paragraphs [0001] to [0011], [0038] to [0051], [0054] to [0059] and [0293] to [0325] of the description, as well as figures 1 to 3B and 30A to 30M.

3. Admissibility of D1''', D3i and D3j

3.1 D1''' is an operating instruction manual for a dialysis machine called "sleep·safe" produced and sold by the appellant. D3i and D3j are affidavits according to which D1''' was made available in a training course on the related dialysis machine, in which members of the public participated.

These documents were filed by the appellant together with the statement of grounds of appeal, and thus well after the period for filing an opposition according to Article 99(1) EPC.

Article 114(2) EPC states that "the European Patent Office may disregard facts or evidence which are not submitted in due time by the parties concerned". Therefore, in the present case, the admission of D1''', D3i and D3j is at the Board's discretion.

Article 12 RPBA provides guidance on how such discretion should be applied. According to Article 12(1) and (4) RPBA, "without prejudice to the power of the Board to hold inadmissible [...] evidence [...] which could have been presented [...] in the first instance proceedings, everything presented by [...the appellant in the statement of grounds of appeal] shall be taken into account by the Board if and to the extent it relates to the case under appeal and meets the requirements in [Article 12(2) RPBA]". As far as the present case is concerned, Article 12(2) RPBA prescribes that the statement of grounds of appeal must contain the appellant's complete case, setting out clearly and concisely the reasons why it is requested that the decision under appeal be reversed and should specify, in particular, all evidence relied on, with the documents referred to to be attached as annexes.

3.2 By filing D1''', D3i and D3j and basing a reasoned novelty objection on them, the appellant fulfilled the requirements of Article 12(2) RPBA.

However, it has to be established whether the appellant could have presented these documents in the first instance proceedings and, if so, whether its failure to do so would lead the Board to hold them inadmissible.

The Board agrees with the respondent that, as a rule, the documents on which an opposition is based should be presented within the time limit for filing the opposition specified in Article 99(1) EPC. However, the Board also notes that appeal proceedings should give the appealing party, adversely affected by a decision at first instance, a fair chance and the means to argue against the findings in that decision. That may include the possibility of filing further relevant evidence, if it is done in reaction to those findings.

The appellant argued that the filing of D1''', D3i and D3j with the statement of grounds of appeal was justified as it constituted a legitimate reaction to the Opposition Division's finding in the impugned decision that D1, D1' and D1'' did not belong to the state of the art. The respondent disputed this.

The Board shares the appellant's view. In essence, D1''' has the same technical content as D1, D1' and D1'' and relates to the same series of "sleep·safe" dialysis systems commercialised by the appellant. It can reasonably be assumed that, at first instance, the appellant expected that the Opposition Division would conclude that at least one of D1, D1' and D1'' belonged to the state of the art, so that there was no need to provide yet further evidence concerning the same series of dialysis systems. However, the Opposition Division decided otherwise, on the ground that the evidence on file was not sufficient to establish beyond any reasonable doubt that the subject-matter of these documents had been made available to the public before the priority date of the patent. The filing of D3i and D3j is an appellant's attempt to address this ground, as they are affidavits aiming at establishing the public availability of, in essence, the same subject-matter. It follows that, from a procedural point of view, the filing of D1''', D3i and D3j with the statement of grounds is justified, and the appellant could not reasonably have been expected to file them at first instance.

3.3 As argued by the respondent in the present case and held in decision T 1002/92, a further requisite for late-filed evidence to be admitted is its prima facie relevance, in the sense that it could reasonably be expected that such evidence would change the final outcome of the case, i.e. that it is likely to prejudice the maintenance of the patent.

The Board notes that, in the present case, such relevance is to be assessed from two different perspectives. The first concerns establishing the public availability of D1''', while the second relates to the relevance of its technical content with respect to the subject-matter claimed in the patent.

3.3.1 As regards establishing the public availability of D1''', the Board notes that D3i and D3j are affidavits, in which the declarants swore under oath that the statements made were true and correct to the best of their knowledge. The Board considers that such statements should be given a high probative value, unless other evidence casts doubts on them. As argued by the appellant, in D3i Mr Jung precisely identified D1''' as the document shown and used as a basis of a training course, which took place before the priority date of the patent, on the related "sleep·safe"dialysis system, delivered to a hospital in Nuremberg, Germany, on 3 January 2002. In D3j Ms Oberdorf, Ms Merten, and Ms Zweschper confirmed that they participated in that training. It is not disputed that these three persons belonged to the public. The alleged contradictions with D3e and D3h, according to which no delivery of a "sleep·safe" dialysis system was made to anyone on 3 January 2002, do not arise, since these documents relate to deliveries outside Germany, as the appellant convincingly argued. It follows that, on a prima facie assessment of this evidence, the availability to the public of D1''' before the priority date of the patent might be established.

As far as the respondent's argument that the appellant did not provide any order, checklist, invoice or delivery/shipping note itemising D1''', the Board notes that such documents do not constitute an exhaustive list of evidence which would be needed to prove the public availability of devices or documents. The appellant is free to provide the evidence at its disposal which may serve that purpose.

As far as decision J 5/11 is concerned, the Board notes that it related to the admissibility of new evidence from within the private sphere of the appellant, submitted during appeal proceedings in the context of an application for re-establishment of rights under Article 122 EPC. The present opposition case is clearly different. Moreover, contrary to the respondent's assertion, it cannot be affirmed that D3j is derived from the private sphere of the appellant, since it was produced by three persons with no apparent relationship with the appellant. It follows that the conclusions in decision J 5/11 are not relevant for the present case.

3.3.2 As regards the technical content of D1''', the Board shares the appellant's view that it is prima facie highly relevant for the subject-matter claimed, since it clearly relates to a dialysis system of the same kind, with a display device showing a plurality of dialysis therapy set-up procedure screens (chapter 2.4), a plurality of dialysis treatment screens (chapter 3.3) and a plurality of dialysis therapy disconnection screens (chapter 4.1), as defined in claim 1 of all requests.

3.4 For these reasons, the Board's decision is to admit D1''', D3i and D3j into the proceedings.

4. Remittal to the Opposition Division

The respondent requested that the case be remitted to the Opposition Division if D1''' is admitted.

According to Article 111(1) EPC, for the examination of the appeal, "the Board of Appeal may either exercise any power within the competence of the department which was responsible for the decision appealed or remit the case to that department for further prosecution".

The respondent argued that the case should be remitted in order for the parties to have two degrees of jurisdiction. However, the Board notes that, according to that article, a party has no absolute right to have two degrees of jurisdiction. Rather, a decision to remit the case is within the Board's discretion.

The Board agrees with the respondent that, in principle, it may be appropriate to allow the parties to have their case examined at two instances. However, this is not the only criterion to be considered when deciding upon remittal. In the present case, as noted above, the technical content of D1''' was available to the parties well before the appeal proceedings started through similar documents already cited in the proceedings. As pointed out by the respondent, its relevance was even assessed by the Opposition Division, albeit preliminarily, in the communication accompanying the summons to oral proceedings at first instance. Moreover, the present case relates to a patent derived from a divisional application with a priority dating back to May 2002, i.e. almost 14 years ago. In view of the present workload at the EPO, a remittal, which may even be followed by a further appeal, will likely result in a further delay of several years, before a final decision is taken. That will lead to an undesirably long time before legal certainty is eventually established.

For these reasons the Board's decision is not to remit the case.

5. Availability to the public of D1'''

As observed in paragraph 3.3.1 above, Mr Jung's sworn statement in D3i precisely identifies D1''', since it clearly refers to a user manual of a "sleep·safe" dialysis system with the Article No. 677 804 1 and the Software Version 1.0, Status 2/10.00, which corresponds to D1'''. According to D3i in conjunction with D3j, D1''' was made available before the priority date of the patent at least to Ms Oberdorf, Ms Merten, and Ms Zweschper, who undisputedly belonged to the public.

The Board is satisfied that this evidence is sufficient to establish that D1''' belongs to the state of the art for the purpose of assessing the novelty and inventive step of the subject-matter claimed in the patent.

6. Patent as granted

D1''' discloses a dialysis system for a user to run a dialysis therapy over a therapy session (page 1-3, chapter 1.1.1). The system comprises a display device included in a touch screen (3 in the figure on page 1-8). It was not disputed that such a display device implies the presence of a suitable controller including a processor, a memory device and software for operating the display device. The latter is operated to display a plurality of dialysis therapy set-up procedure screens (chapter 2.4, starting on page 2-8) and to require an input by the user to proceed through the dialysis therapy set-up procedure screens (by pressing the virtual button "->" on the dialysis therapy set-up procedure screens). After the dialysis therapy set-up procedure is complete, the controller is operable with the display device to display a plurality of dialysis treatment screens that graphically illustrate steps in the dialysis therapy and that do not require an input by the user to proceed through the dialysis treatment screens (chapter 3.3 starting on page 3-18). After the therapy session is complete, the controller is operable with the display device to display a plurality of dialysis therapy disconnection screens (chapter 4.1 starting on page 4-3) and to require an input by the user to proceed through the dialysis therapy disconnection screens (by pressing the virtual button "->" on the dialysis therapy disconnection screens).

Concerning the respondent's argument that D1''' failed to disclose the display of a plurality of dialysis treatment screens that do not require an input by the user to proceed through them, the Board notes that, on page 3-18, first sentence, D1''' explicitly mentions that each treatment cycle is displayed during the treatment:

"Jeder Behandlungszyklus wird während der Behandlung auf dem Bildschirm angezeigt."

Since there is no specific mention that any action is needed from the user for such a display to take place, the skilled person, in the specific context of a treatment consisting of a sequence of cycles, can only conclude that such a display will take place sequentially, cycle after cycle. The Board agrees with the appellant that the author of D1''' would have explicitly mentioned the requirement of a user action only if such an action had been needed.

If follows that D1''' discloses all the features of claim 1 of the patent as granted. As a consequence, the subject-matter of the claim is not novel.

Hence, the ground for opposition according to Article 100(a) EPC in conjunction with Articles 52(1) and 54 EPC prejudices the maintenance of the patent as granted.

7. Auxiliary request 1

D1''' further discloses an input device of the dialysis system, included in touch screen 3 as virtual button "?" on the dialysis therapy set-up procedure screens (chapter 2.3), that operates to stop proceeding through the dialysis therapy set-up procedure screens (as explained on page 2-7), and an input device of the dialysis system, included in touch screen 3 as virtual button "<-" on successive dialysis therapy set-up procedure screens (chapter 2.4), that operates to cause a display of a previously displayed screen of the dialysis therapy set-up procedure screens (as explained for example on page 2-10).

The respondent argued that the additional features of claim 1 of auxiliary request 1 implied the capability of the claimed system of stopping and resuming a set-up procedure, which was not possible with the system according to D1'''. However, the Board does not share this view, since in the system according to D1''', by pressing the "?" button a user enters a help mode which interrupts the set-up procedure until the user exits that mode. Hence, with the system according to D1''' the set-up procedure can also be stopped and resumed by the user.

As a consequence, D1''' anticipates the subject-matter of claim 1 of auxiliary request 1 too.

Hence, the patent cannot be maintained on the basis of auxiliary request 1 due to non-compliance with Article 52(1) EPC in conjunction with Article 54 EPC.

8. Auxiliary request 2

As the respondent argued, D1''' fails to disclose that the plurality of dialysis therapy set-up screens have a first coloration and the plurality of dialysis treatment screens have a second coloration.

However, the Board notes that no specific colorations, in particular dependent on day or night conditions, are defined in claim 1 of auxiliary request 2. Hence, the problem of improving the dialysis treatment by minimising disruption of a user's sleep, as formulated by the respondent, is not solved over the whole scope of the claim.

Two arbitrarily chosen different colorations as claimed may at most serve the purpose of somehow differentiating the dialysis therapy set-up screens from the dialysis treatment screens. In D1''' this is already achieved by providing a different layout and different written information (figures in chapters 2.4 and 3.3).

It follows that the problem solved by the differentiating feature of claim 1 of auxiliary request 2 may be seen as an alternative or additional way of identifying the dialysis therapy set-up screens and the dialysis treatment screens.

As the appellant argued, D1''' discloses that touch screen 3 is in colour (page 1-4, second paragraph). The Board also agrees with the appellant that providing different colorations for different screens relating to different processes was commonly done in the field of computer displays. This could even be inferred in D1''', comparing the coloration of the help mode screens in the figures on page 2-7 with the coloration of the dialysis therapy set-up screens and the dialysis treatment screens. The skilled person would therefore implement two different colorations as claimed in the system of D1''' in an obvious way, according to circumstances.

As a consequence, the subject-matter of claim 1 of auxiliary request 2 lacks an inventive step.

Hence, the patent cannot be maintained on the basis of auxiliary request 2 due to non-compliance with Article 52(1) EPC in conjunction with Article 56 EPC.

9. Auxiliary requests 3 and 4

As the appellant argued, D1''' discloses that the controller is operable with the display device to display a selection screen having different parameters available for selection (by pressing the virtual button leading to the menu "Optionen" as disclosed in chapter 3.4 starting on page 3-21) and to allow the user to navigate (second half of page 3-21) between therapy screens (screens reached by pressing virtual buttons "Verweilen Überspringen" and "Behandlung abbrechen") , parameter changes screens (screens reached by pressing virtual buttons "Lautstärke ändern" and "Bildschirmeinstellungen ändern") and log information screens (screens reached by pressing virtual button "Momentane Behandlungsergebnisse anzeigen"), wherein the therapy screens include graphics and text pertaining to at least patient dwell (virtual button "Verweilen Überspringen").

D1''' does not disclose that the parameters available for selection in the selection screen are grouped in categories.

As the respondent submitted, grouping the different parameters in categories available for selection in a category selection screen, as required by claim 1 of auxiliary requests 3 and 4 may be considered to address the problem of providing a more user-friendly system, since the selection of a particular parameter from amongst several could be facilitated.

However, grouping similar parameters in a category and making them accessible by first selecting the specific category is no more than an obvious design measure. This is also taught in D1''' in relation to the display of different log information screens, where a specific screen relating to a certain parameter is displayed by first selecting a more general parameter category (by pressing virtual button "Momentane Behandlungsergebnisse anzeigen") and then selecting the specific parameter (by pressing the related virtual button as explained in chapter 4.2).

As a consequence, the subject-matter of claim 1 of auxiliary requests 3 and 4 lacks an inventive step too.

Hence, the patent cannot be maintained on the basis of auxiliary requests 3 or 4 due to non-compliance with Article 52(1) EPC in conjunction with Article 56 EPC.

10. Since none of the respondent's requests can form a basis for the maintenance of the patent, the patent has to be revoked pursuant to Article 101(2) and (3) EPC.

11. Having reached that conclusion, the Board need not elaborate on further objections raised by the appellant, in particular based on lack of novelty over D1 and on Article 100(c) EPC.