T 0888/18 26-03-2021
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A URINARY CATHETER
Novelty - main request (yes)
Inventive step - main request (yes)
Amendment after summons - exceptional circumstances (no)
Amendment after summons - taken into account (no)
I. The appeal was filed by the opponent (appellant) against the opposition division's decision to reject the opposition.
II. Oral proceedings were held by videoconference before the Board on 26 March 2021.
III. The appellant (opponent) requested that the decision under appeal be set aside and that the patent be revoked.
The respondent (patent proprietor) requested that the appeal be dismissed or, alternatively, that the patent be maintained on the basis of one of the auxiliary requests A, B or C filed with the letter of 12 October 2018.
IV. The following evidence is used:
D1: EP 0 384 476 B1
D6: US 2005/033237 A1
D10: GB 2 230 702 A
D11: US 4 750 877
D12: "Plastics Engineering Handbook" of the Society of the Plastics Industry, Inc., fourth edition, 1976, ISBN: 0-442-22469-0, pages 653-654
V. Independent claim 1 of the patent as granted reads as follows (with feature denominations following the appealed decision):
"(A1) A urinary catheter (1, 20, 40, 50, 60, 70) comprising:
(A2) - a tube part (2, 21, 41, 51, 61, 71) having a proximal end (6, 22, 43) and a distal end (4, 23, 44) and having a wall defining an inner lumen (12) of the tube portion,
(A3) - a tip part (3, 24) having a proximal end (8) and a distal end (7)
(A4) where the proximal end (8) of the tip part is the most proximal part of the urinary catheter and
(A5) the distal end (7) of the tip part abuts the proximal end (6, 22, 43) of the tube part, , [sic]
(A6) where the tip part closes off the proximal end of the tube part
(A7) - at least one through-going opening (9, 10, 25, 26)
(A8) where the through-going opening (9, 10, 25, 26) is positioned in the wall of the tube part
(A9) distal to the proximal end of the tube part,
characterized in that
(A10) the tube part (2, 21, 41, 51, 61, 71), at its proximal end (6, 22, 43), has a first outer diameter (i) that is smaller than a second outer diameter (j) at the distal end (4, 23, 44) of the tube part,
(A11) and the outer diameter of the tube part increases constantly along the entire length of the tube part from its proximal first outer diameter end to its distal second outer diameter where the outer surface is at an angle alpha in relations [sic] to the central longitudinal axis of the tube part."
VI. The appellant's arguments can be summarised as follows.
(a) Novelty in view of D1
It was common ground that D1 disclosed Features A1-A7, A9 and A10.
Claim 1 did not define the length of the tip part or where it abutted the tube part. Therefore, the ball-shaped enlargement ("kugelförmige Verdickung" 8, Figure 2) of the catheter tip ("Spitze" 4) from D1 could be considered the "tip part" from claim 1. The remaining portion of the tip 4 comprised a section with a tapered outer surface which could be understood to represent the "tube part" from claim 1. With this feature subsumption, the outer diameter of the "tube part" increased constantly along the entire length of the "tube part". Accordingly, D1 also disclosed Feature A11.
D1 disclosed on page 3, lines 43-44 that the through-going openings ("Augen" 5) could be located at different positions on the catheter. Accordingly, D1 disclosed embodiments in which a through-going opening was positioned in the tapered tip representing the "tube part", thus disclosing Feature A8.
Hence, D1 disclosed all the features of claim 1.
(b) Novelty in view of D10
D10 undisputedly disclosed a urinary catheter with Features A1-A5 and A7.
D10 stated that "the tip could be open or closed" (page 2, line 1). Therefore, Feature A6 was also disclosed.
The "tapered cylindrical portion" 2 from D10 represented the "tube part" from claim 1, fulfilling Features A10 and A11.
However, as claim 1 did not define the length of the tip part or where it abutted the tube part, the "tube part" in D10 could be considered to also include the section of the catheter comprising the through holes or "eyes" (5), and therefore Features A8 and A9 were also disclosed.
Accordingly, D10 disclosed all the features of claim 1.
(c) Inventive step starting from D1
In its written submission the appellant had submitted that the subject-matter of claim 1 lacked an inventive step over D1 and the common general knowledge in view of the technical problem of easier insertion of the catheter by gradually opening up or expanding the urethra (paragraph [0012] of the patent).
At the oral proceedings, the appellant argued that the distinguishing Feature A11 did not solve this problem. In view of the less ambitious problem of providing an alternative catheter, the subject-matter of claim 1 did not involve an inventive step with respect to a combination of D1 with D6.
The appellant submitted that this objection was not an amendment to its appeal case because:
it formed part of the decision under appeal (section 11, ninth paragraph),
it was used in the grounds of appeal against claim 8 (page 7/7), and
it was addressed by the respondent in its letter of 26 February 2021 (section 2.5).
Accordingly, the objection based on D1+D6 was part of the appellant's appeal case and its admittance was not subject to the Board's discretion.
(d) Inventive step starting from D10
The distinguishing Feature A11 did not solve the objective technical problem of "easier insertion" of the catheter reported in the patent (paragraph [0012]).
According to paragraph [0017] of the patent, easier insertion was achieved by varying the wall thickness along the length of the catheter; however, this feature was already known from D10 (page 2, lines 5-6; figure). The stated problem was thus already solved in the closest prior art.
Furthermore, claim 1 did not define the size and shape of the tip part. According to paragraph [0013] it encompassed tip parts with a substantially spherical end, which, according to D1 (page 2, lines 27-31), was detrimental to gentle insertion. Hence, the problem of "easier insertion" was not solved across the full scope of claim 1.
Instead, it was known in the art (cf. D12) that a slight draft angle was necessary for injection moulding for removing the finished product from the mould. The same was also disclosed for the manufacture of catheters in D6 (paragraphs [0130], [0058] and [0063]) and D11. Accordingly, the tapering defined by the distinguishing Feature A11 solved the objective technical problem of providing a catheter suitable for injection moulding.
In view of the common general knowledge or D6, the skilled person would have solved this problem by providing a slight draft angle along the entire catheter assembly, i.e. also along the "cylindrical tubular portion" 3 from D10 comprising the "eyes" 5. In doing so, the skilled person would have arrived at the subject-matter of claim 1 in an obvious way.
The same held true even if the submitted problem regarding injection moulding could not be followed. The objective technical problem would then have to be reformulated in a less ambitious manner as that of providing an alternative catheter. Even when merely looking for alternative catheter designs, D6 would have prompted the skilled person to provide a slight taper along the entire catheter assembly.
Accordingly, the subject-matter of claim 1 did not involve an inventive step with respect to D10 in combination with the common general knowledge or D6.
VII. The respondent's arguments can be summarised as follows.
(a) Novelty in view of D1
D1 disclosed a two-part structure matching that found in the patent. The tip part from claim 1 was to be equated with the "tip" (4) from D1, and the "tube part" was represented by the catheter shaft ("Katheterschaft" 2). With this understanding, D1 did not disclose Feature A11, because it could not be derived from D1 that the catheter shaft was tapered.
On page 3, lines 43-44, D1 merely disclosed that the eyes (5) could be arranged at different positions on the catheter shaft (2), not on the tip (4). Even when following the alternative feature subsumption presented by the appellant, D1 thus did not disclose Feature A8.
(b) Novelty in view of D10
D10 disclosed through-going openings (5) only in the "cylindrical tubular portion" (3) of the catheter. Either the "tube part" did not comprise the openings (Features A8 and A9) or it comprised a cylindrical section, and therefore its outer diameter did not increase constantly along its entire length (Feature A11). D10 thus did not disclose all the features of claim 1.
(c) Inventive step starting from D1
The appellant's attack based on D1+D6 and the formulation of the technical problem as that of providing an alternative catheter in view of D1 were submitted in the appeal proceedings for the first time at the oral proceedings, thus representing an amendment to the appellant's appeal case which was not to be admitted under Article 13(2) RPBA 2020.
With regard to D1, the distinguishing Feature A11 solved the problem of easier insertion of the catheter stated in the patent (paragraph [0012]) because it allowed more gentle, gradual expansion of the urethra over a greater length. This problem was not addressed in the remaining prior art. Furthermore, throughout the prior art, side openings were only positioned in cylindrical portions of the catheter. Therefore, neither the prior art nor the common general knowledge suggested positioning side openings in a tapered portion of a catheter or providing a taper to the catheter portion where the side openings were positioned.
Therefore, the subject-matter of claim 1 involved an inventive step with respect to D1.
(d) Inventive step starting from D10
The distinguishing Feature A11 solved the problem of easier insertion of the catheter (paragraph [0012] of the patent).
The fact that claim 1 did not specify all the details of the tip part did not mean that it was justified to assume properties that were detrimental to the solution to the problem stated in the patent. Claim 1 did not encompass such embodiments.
D10 already disclosed urinary catheters suitable for injection moulding (page 1, lines 14-16; page 3, lines 4-6). Accordingly, the problem of providing a catheter suitable for injection moulding submitted by the appellant did not arise in view of D10. Furthermore, D10 explicitly disclosed a cylindrical portion of constant outer diameter (page 3, lines 1-3) in an injection-moulded catheter. D6, too, disclosed that a draft angle of 0° was sufficient. Therefore, a draft angle was not necessary for injection moulding and did not solve the problem submitted by the appellant.
D6 did not relate to urinary catheters or to easier insertion. It thus would not have been considered by the skilled person.
Even if the skilled person had consulted paragraph [130] of D6, they would have selected a draft angle of 0° as disclosed therein because this would have maintained the structure from D10, which was specifically designed for urinary catheterisation.
As none of the prior art documents disclosed a tapered portion containing side holes, the skilled person would not have arrived at the subject-matter of claim 1 in an obvious way. Accordingly, the subject-matter of claim 1 involved an inventive step when starting from D10.
1. Novelty in view of D1
1.1 D1 discloses a urinary catheter (1) with a closed proximal tip ("Spitze" 4, Figure 2) and a separate catheter shaft ("Katheterschaft" 2). The catheter shaft has a wall defining an inner lumen and through-going openings ("Augen" 5 in Figures 1 and 3, "für die Harnableitung", page 1, lines 6-7) positioned in the wall.
If the catheter shaft 2 is equated with the "tube part" from claim 1, D1 discloses Features A1-A9; however, D1 at least does not unambiguously disclose that the outer diameter of the catheter shaft increases constantly along its entire length (Feature A11).
1.2 As submitted by the appellant, claim 1 does not define the length of the "tip part" and where it abuts the "tube part". The term "part" in claim 1 is understood to be a mere denomination for different portions of the catheter (see the alternative wording "tube portion" in claim 1), and not to define structurally distinct pieces. Although D1 discloses two separate pieces (2 and 4), these thus do not necessarily have to be equated with the "tube part" and "tip part" from claim 1. Therefore, a different feature subsumption is possible, as argued by the appellant.
The "ball-shaped enlargement" (8, Figure 2) up to the neck-shaped section (7) in D1 could be regarded as the "tip part" from claim 1 of the patent. The "tube part" from claim 1 could then be seen in the remaining "straight and conically tapered" (claim 1 of D1) portion of the tip (4) from D1.
With this understanding, the outer diameter of the "tube part" increases constantly along its entire length, disclosing Features A10 and A11; however, the through-going openings ("Augen" 5) are not positioned in the wall of the tube part (Feature A8). The passage on page 3, lines 43-44, also merely discloses that the openings could be positioned at different positions on the catheter shaft ("Katheterschaft" 2), not in the tapered tip (4).
1.3 Finally, if the "tube part" was considered to extend further distally to include the through-going openings, it would no longer exhibit an outer diameter which increases "constantly along its entire length" (Feature A11).
1.4 Accordingly, irrespective of which feature subsumption is used, D1 does not disclose all the features of claim 1 of the patent as granted. Hence, the subject-matter of claim 1 is novel with respect to D1.
2. Novelty in view of D10
2.1 D10 discloses a urinary catheter with a proximal "cylindrical tubular portion" (3) including "through holes" (5) in its wall (page 1, lines 19-21) and a more distal "tapered tubular portion" (2; page 1, lines 17-18). D10 thus undisputedly discloses Features A1-A5 and A7.
2.2 Although the catheter is disclosed with an open proximal end in the detailed description (page 2, lines 18-24) and in the figure, D10 discloses more generally that "the tip may be open or closed" (page 2, line 1). Hence, Feature A6 is also disclosed.
2.3 With the same considerations as above (point 1.2 of the Reasons), the section of the "cylindrical tubular portion" comprising the through-going openings may be considered to form part of the "tube part" of claim 1. Hence, Features A8 and A9 are also known.
2.4 However, the section comprising the through-going openings is "cylindrical" and thus does not exhibit an outer diameter increasing constantly along its entire length (Feature A11).
2.5 Accordingly, the subject-matter of claim 1 is also novel with respect to D10.
3. Inventive step starting from D1
3.1 D1+D6
At the oral proceedings, the appellant argued that claim 1 did not involve an inventive step in view of D1 in combination with D6. With regard to D1, the objective technical problem was to be considered that of providing an alternative catheter, and the skilled person would have considered the tapering along the entire length of the catheter as disclosed in D6 to be a suitable alternative, which they would obviously have implemented.
3.1.1 Admittance
In the decision under appeal the opposition division decided that the technical problem starting from D1 was the easier insertion of the catheter and it only briefly mentioned D6 in this context.
In the statement setting out its grounds of appeal, which must contain a party's complete appeal case pursuant to Article 12(3) RPBA 2020, the appellant agreed with this problem and argued lack of inventive step starting from D1 only in view of the common general knowledge. D6 was only used in combination with D10. In addition, D6 was briefly mentioned with regard to claim 8, but without any substantiation. Accordingly, the objection of lack of inventive step starting from D1 in combination with D6 for solving the problem of providing an alternative catheter was not part of the appellant's appeal case under Article 12(3) RPBA 2020.
It is true that D6 was referred to by the respondent in its letter of 26 February 2021 (section 2.5), but only in reply to the appellant's objection starting from D10.
Hence, the objection based on D1 in combination with D6 in order to provide an alternative catheter presented during the oral proceedings for the very first time represents an amendment to the appellant's appeal case made after notification of a summons to oral proceedings.
According to Article 13(2) RPBA 2020, this objection may be disregarded, subject to the Board's discretion, and will, in principle, not be taken into account at such a late stage unless there are exceptional circumstances which have been justified with cogent reasons by the party concerned.
In this case, the appellant did not invoke exceptional circumstances and did not submit a justification for the amendment of its case at this stage. The Board thus exercised its discretion to disregard the new objection starting from D1 presented at the oral proceedings.
3.2 In view of D1 alone
In the written proceedings the appellant had set out an objection of lack of inventive step in view of D1 alone and the technical problem of easier insertion of the catheter as stated in the patent (paragraph [0012]).
In a communication under Article 15(1) RPBA 2020 the Board had set out its preliminary opinion with reasons why it considered that the subject-matter of claim 1 involved an inventive step with respect to D1 (point 3.4 of the communication).
Briefly, D1 already concerns the problem of easier insertion (page 2, lines 47-48). The solution it discloses resides in a particular shape of a separately manufactured (page 3, lines 1-5; page 3, lines 42-43) tip ("Spitze" 4) including a conical section (page 2, lines 49-53). It thus would not have been obvious to the skilled person to modify the other separately manufactured piece by providing a further taper to the catheter shaft ("Katheterschaft" 2). Furthermore, D1 points to the risk of injuries due to the sharp edges of the lateral "eyes" (page 2, lines 32-37). Providing these openings on a tapered surface (or a taper in the section of the openings) would have worsened this effect. It was thus not obvious to the skilled person to modify the catheter from D1 so as to arrive at the subject-matter of claim 1.
This line of attack was not pursued any further during the oral proceedings, and the Board does not see any reason to deviate from its preliminary opinion.
3.3 Accordingly, the subject-matter of claim 1 involves an inventive step with respect to D1 as the closest prior art.
4. Inventive step starting from D10
4.1 Claim 1 differs from the urinary catheter of D10 on account of Feature A11. It specifies that "the outer diameter of the tube part increases constantly along the entire length of the tube part from its proximal first outer diameter end to its distal second outer diameter where the outer surface is at an angle alpha in relations [sic] to the central longitudinal axis of the tube part."
4.2 The patent defines that the term "constantly increasing" means a linear increase at a constant ratio resulting in an inclination of the outer surface of the tube part at a predefined angle with respect to a central longitudinal axis of the tube part along its entire length (paragraph [0009]).
Claim 1 does not explicitly mention "linear", a "constant rate of increase", or that the entire outer surface of the tube part (other than at its "distal second outer diameter") must be at a predefined angle with respect to the central longitudinal axis of the tube part. According to the established case law (Case Law of the Boards of Appeal of the European Patent Office, 9th edition, 2019, II.A.6.3.4), it is not permissible, for the purposes of judging novelty and inventive step, to read into the claim restrictive features not suggested by the explicit wording of the claim.
In this case, however, agreeing with the respondent, the Board concedes that the claimed feature "the outer diameter increases constantly along the entire length of the tube part" by itself must be interpreted such that the increase of the outer diameter is constant with respect to length, i.e. its rate of increase is constant along the entire length of the tube part.
4.3 According to paragraph [0012] of the patent, a "conically shaped" catheter tube, i.e. a tube part with a constant, linear increase in the outer diameter along its entire length as defined in claim 1 (see preceding point), allows easier insertion because it more gently, gradually expands the urethra upon gradual insertion of the catheter. The respondent thus submitted that Feature A11 solved the problem of allowing "easier insertion".
4.4 The appellant's counter-arguments are considered in the following.
4.4.1 Problem already solved by D10
The appellant submitted that the problem of easier insertion indicated in the patent (paragraph [0012]) was already solved by D10, which also disclosed varying wall thicknesses along the length of the catheter (page 2, lines 5-6; figure).
However, the problem of easier insertion is a relative one. The fact that a certain advantage with respect to ease of insertion is achieved in the prior art does not mean that the skilled person would not look for further improvements in this regard.
Furthermore, the appellant's counter-argument relates to the effect of additional features (paragraph [0017]) not specified in claim 1, and not to the effect of the conical tube part reported in paragraph [0012].
Accordingly, the Board does not see a reason why the problem of allowing "easier insertion" could not be invoked by the respondent.
4.4.2 Problem not solved across the full claimed scope
The appellant submitted that claim 1 encompassed embodiments which did not achieve easier insertion. In particular, it argued that the patent suggested that the end of the tip part could have a rounded spherical shape (paragraph [0013]). Such a tip shape was, according to D1 (page 2, lines 27-31), disadvantageous for the gentle insertion of the catheter. As claim 1 did not specify the shape of the tip part, it encompassed embodiments which made insertion more difficult and did not solve the problem of easier insertion.
The Nélaton and Mercier catheters referred to in D1 and described as disadvantageous indeed have a similar spherically rounded tip shape to that shown in the patent. However, in these catheters the tip and the tube part have the same diameter and the spherical rounding is the only region of increasing diameter. The expansion of the urethra thus takes place over the short length of the spherically rounded tip and with higher pressure. In contrast thereto, the catheter from claim 1 comprises a tapering tube part which assumes the function of gradually and gently expanding the urethra. The proximal tip may thus be of smaller diameter and therefore does not exhibit the disadvantages mentioned in D1.
It is true that claim 1 does not specify how small the tip is, how long the tube part is, and how shallow its taper is, but a claim must be interpreted from the perspective of the skilled person, who would not fill gaps in the claimed subject-matter with features contradicting the intended purpose.
For these reasons, it is considered that the distinguishing Feature A11 solves the problem of easier insertion in the sense of a more gentle and gradual expansion of the urethra essentially across its full claimed scope.
4.4.3 Alternative problem regarding injection moulding
The appellant submitted that Feature A11 objectively
exhibited a different technical effect (and solved a different problem) unrelated to that disclosed in the patent. Such a situation, and a corresponding objection of lack of inventive step, is possible in principle.
The appellant argued that D10 concerned the manufacture of a urinary catheter in one piece in a single forming step, preferably by injection moulding (page 1, lines 14-16). In this context, it was also necessary to provide the "cylindrical tubular portion" (3) comprising the through-going openings with a slight taper for removing the finished product from the mould. Feature A11 thus solved the problem of providing a catheter suitable for injection moulding.
However, D10 already discloses a catheter formed by injection moulding (page 3, lines 4-6), yet explicitly comprising a "cylindrical" portion 3 of constant outer diameter (page 2, line 25 - page 3, line 3). The problem formulated by the appellant is thus already completely solved in the closest prior art.
The appellant's problem could, however, be reformulated more generally as "easier" injection moulding. Such a statement of the problem could be justified if feature A11 provided beneficial effects for injection moulding that were clearly recognisable and credible for the skilled person. The appellant submitted some evidence to that end.
D12 discloses (page 653, "Taper or Draft" section) that a draft or taper "should" be provided, but also that "straight-sided" parts can be removed with stronger pull forces. "Draft will also vary", inter alia, "according to [...] the particular plastic being moulded". In the preceding section on page 653, D12 even discloses that it may be possible to snap or strip undercuts from the mould depending on the product's ability to stretch. It may thus be concluded from D12 that a draft or taper is not always required, and whether it provides noticeable advantages strongly depends on the material properties of the product, inter alia.
D6 discloses that the surfaces of an indwelling intravascular or parenteral catheter "may" include a slight draft angle which may be varied to aid in production steps, including removal from the mould (paragraphs [0058] and [0063]). Paragraph [0130] suggests a draft angle "on the order of 0.125°", but adds that the catheter could, alternatively, be moulded with a draft angle of 0°. The teaching of D6 regarding actual advantages of a draft angle is thus quite vague. In view of the different structural and mechanical requirements on indwelling catheters (as in D6) compared with urinary catheters, it cannot be derived from D6 that a draft angle provides noticeable advantages for the urinary catheter of D10.
D11 was only briefly mentioned by the appellant, but without substantiating specific facts.
In summary, on the one hand, D10 discloses a catheter suitable for injection moulding with a section that is explicitly disclosed without a taper. On the other hand, the evidence submitted by the appellant does not prove that a tapered tube part provides a recognisable advantage with respect to injection moulding of the catheter of D10. Hence, the alternative problem of Feature A11 regarding injection moulding submitted by the appellant is not justified.
4.4.4 Problem of providing an alternative catheter
At the oral proceedings the appellant also submitted the less ambitious problem of providing an alternative catheter, should the Board not be convinced by the problem regarding injection moulding; however, as Feature A11 solves the more specific objective technical problem of allowing "easier insertion" submitted by the respondent (see point 4.4.2 of the Reasons), there is no scope for a less ambitious problem.
4.4.5 Consequently, the objective technical problem of Feature A11 is that of allowing easier insertion.
4.5 As set out above in point 3.2 of the Reasons, D1 is concerned with the same problem and the solution it discloses resides in a particularly shaped, separately manufactured tip proximal to the side openings (5).
The catheter design from D1 (two pieces, tapered tip, cylindrical tube) differs considerably from that from D10 (single piece, cylindrical tip, tapered tube), and therefore it is questionable whether the skilled person would have considered applying the tip from D1 to the catheter from D10 at all.
If they had done this, however, the tip would have been provided proximally to the side openings, in accordance with the teaching of D1 and for the same reasons as argued in point 3.2 of the Reasons. The through holes 5 from D10 would thus still be positioned in a cylindrical section of the catheter. Therefore, the skilled person would not have arrived at the subject-matter of claim 1.
4.6 D6 is not concerned with easier insertion of a urinary catheter, and thus would not have prompted the skilled person to modify the catheter from D10. In addition, none of the available prior art documents discloses through holes in a tapered portion of the catheter.
4.7 Hence, the subject-matter of claim 1 also involves an inventive step when starting from D10.
5. For the above reasons, none of the grounds for opposition considered in the appeal proceedings prejudices the maintenance of the patent as granted.
For these reasons it is decided that:
The appeal is dismissed.