T 2329/15 08-09-2020

Reasons for the Decision

1. The invention

The application relates to a biopsy cavity marker device comprising two nonabsorbable marker elements, one detectable by X-ray, the other by ultrasound. Such a marker device helps to identify a biopsy site in a subsequent examination of the site, in particular the location and orientation of the cavity (page 2, paragraph 2). The use of nonabsorbable marker elements allows to permanently mark the location of the cavity (page 3, paragraphs 4 and 5).

Claim 1 defines the ultrasound detectable second marker element as comprising a nonabsorbable polymer and the X-ray detectable first marker element as comprising a metal and to wrap around a portion of the second marker element (see Figures 1D-1G; page 8, lines 6 to 9; page 9, paragraph 2).

2. Main request

2.1 Document D6 is addressed at intraluminal stents or grafts suited for treatment of aneurysms and diseased blood vessels and other bodily lumen needing such a prosthesis (column 1, lines 57 to 60). D6 discloses in Figure 1A a stent having a polymeric tubing (102) ("second marker element" of the claim) (column 3, lines 1 to 5) and a radiopaque metal marker (110) ("first marker element" of the claim) wrapped around a portion of the former (column 3, lines 12 to 17; Figure 1A). The polymeric tubing may comprise polypropylene (column 3, lines 25 to 28). It results from common general knowledge that the polymeric tubing (102) will be detectable by ultrasound depending, inter alia, on the acoustical impedance of the tissue surrounding the stent, and that the radiopaque metal marker (10) is detectable by X-ray.

The appellant asserted that D6 did not disclose a nonabsorbable polymer marker. While this property is indeed not explicitly mentioned in D6, it is inherent to the polypropylene stent tubing disclosed (in column 3, lines 25 to 28), since the application describes polypropylene as a nonabsorbable polymer (page 9, third paragraph, first sentence). Moreover, dependent claim 9 of the main request specifies polypropylene as a preferred embodiment of the nonabsorbable polymeric marker defined in claim 1.

2.2 Claim 1 is addressed at a "biopsy cavity marking device". Hence, the claim defines a device that is suitable for marking a cavity which may have originated from a biopsy.

It is established jurisprudence that a formulation such as "apparatus for" is to be interpreted as meaning an apparatus which is suitable for the stated use (Case Law of the Boards of Appeal, 9**(th) edition, 2019, I.C.8.1.5). Any prior art apparatus which, in addition to features expressly mentioned in the claim also possesses these implicit physical features and can thus reasonably be used for the stated purpose, will then take away novelty of the claimed apparatus. This is irrespective of whether or not the prior art mentions the stated use or purpose or whether the stated use is obvious or not. This is because the claim is directed at the apparatus, not its use. Nor can stating a use that is new and not-obvious render an apparatus which is already known novel and inventive.

2.3 As indicated above, D6 is addressed at intraluminal stents or grafts suited for treatment of aneurysms and diseased blood vessels and other bodily lumen needing such a prosthesis. Given the physical properties of the stent depicted in Figure 1A of D6, the Board considers that it is likewise suited to be used for marking a cavity which may have originated from a biopsy, even if D6 does not mention this purpose or use.

2.4 None of the reasons presented by the appellant convinced the Board that it was not reasonable to consider the stent of D6 as being suitable for the claimed purpose.

2.4.1 The Board finds it undisputable that the stent of Figure 1A of D6, comprising two radiopaque metal markers (110), is designed for radiographically marking its position in the vasculature. If the stent was inserted into any other cavity of the body, the markers would still allow to determine its position. The appellant's argument that the stent would not allow marking the center of a biopsy cavity, as explained on page 2, paragraphs 2 and 3 of the application, is not relevant since this purpose is not defined in claim 1. Even if it was, it is noted that the two markers at each end of the stent would also allow to determine a center point between the markers.

2.4.2 The appellant argued, moreover, that no medical practitioner would consider using a stent for marking a biopsy cavity. It was argued that after release of the compressive forces applied during breast biopsy procedures, the flexible, hollow tubular stent of Figure 1A of D6 would deform or move, so that the orientation and location of the margins of the cavity would be lost. Furthermore, placement of a hollow tubular stent in a biopsy cavity would hinder the regrowth of tissue within the cavity.

The Board does not consider that the stent of D6 would necessarily deform or move when inserted into a cavity. Stents are designed to be fixedly positioned and secured within the vasculature and will normally not move once inserted. The application and release of compressive forces mentioned by the appellant in the particular context of breast biopsies is no general prerequisite for placing a marker in a biopsy cavity. The appellant's assertion that tissue would be hindered to regrow within the lumen of the stent does not appear to be a proven reason deterring the skilled person from using the stent within a cavity.

2.5 The Board therefore concludes that the device of claim 1 lacks novelty within the meaning of Article 54 EPC.

3. Third auxiliary request

3.1 In claim 1 of the third auxiliary request, the second marker element detectable by ultrasound is further specified as being "not detectable by X-ray". The request was filed about one week prior to the oral proceedings. As the substance of the request corresponds to that of the second auxiliary request, the Board admitted it into the proceedings.

3.2 As explained in the application on page 7, paragraph 3, the expression "not detectable" means that there is no significant visualisation of the second marker element by X-ray. The expression provides therefore a rather unspecific, qualitative indication about the insignificant visualisation of the second marker element using an (unspecified) X-ray detection system.

D6 discloses that tubing 102 (the "second marker element") is made of polypropylene (column 3, lines 25 to 28), one of the polymers listed in dependent claim 9 of the third auxiliary request as examples of a marker "not detectable by X-ray". Consequently, also the polypropylene tubing in D6 will be hardly visualised by X-ray (depending on the X-ray imaging modality), and therefore, "not detectable by X-ray".

3.3 The device of claim 1 of the third auxiliary request therefore lacks novelty.

4. New second auxiliary request

4.1 The appellant explained that in order to remedy the raised novelty objection, amended claim 1 filed during oral proceedings was formulated as a purpose-related product claim in the sense of Article 54(5) EPC specifying a medical use otherwise excluded from patentability under Article 53(c) EPC. Claim 1 was no longer addressed at a device, but at a "composition" of first and second marker elements for use in a biopsy cavity marking device for identifying a subcutaneous biopsy cavity and for long-term follow-up of the subcutaneous biopsy cavity.

4.2 Article 13(2) RPBA 2020 specifies that any amendment to a party's case filed after notification of a summons to oral proceedings "shall, in principle, not be taken into account unless there are exceptional circumstances, which have been justified with cogent reasons by the party concerned".

4.3 When queried about the reasons justifying the late filing of the request during oral proceedings, the representatives explained that the request was filed in response to the novelty objections raised in the communication accompanying the summons to oral proceedings. It had not been possible to file it earlier since the representatives had been unable to contact the appellant for months.

4.4 The Board disagrees. The appellant's lack of involvement in the prosecution of the present case, as unusual as it may be, can in the current case not be regarded as "exceptional circumstances" which may lead the Board to admit the filing of the new second auxiliary request after notification of the summons to oral proceedings. "Exceptional circumstances" generally concern new or unforeseen developments of the appeal proceedings themselves, such as new objections raised by the Board (or another party). In the present case, however, the novelty objection in view of D6 had already been raised by the Examining Division and formed part of the reasons for the impugned decision. Thus, whether or not the appellant's representatives were unable to liaise with their clients in the period between notification of the summons and the oral proceedings is of no relevance to the issue of admittance of the request into the proceedings.

4.5 The Board, therefore, exercised its discretion under Article 13(2) RPBA 2020 not to admit the new second auxiliary request.

5. First and second auxiliary requests

5.1 Claim 1 of the first and second auxiliary requests corresponds to claim 1 of the main and third auxiliary requests, respectively, with the following amendment: "the first marker element wraps around [deleted: a portion of][deleted: ]the second marker element".

5.2 The subject-matter of claim 1 of the first and second auxiliary requests is thus a generalisation of the subject-matter of claim 1 of the main and third auxiliary requests, respectively.

5.3 As a consequence, the aforementioned objection of lack of novelty applies likewise to the first and second auxiliary requests.