T 1579/17 09-05-2022

Reasons for the Decision

1. Admissibility of the appeal

The respondent argued that the appeal was inadmissible because it presented a new case rather than setting out the reasons why the impugned decision should be reversed.

In the statement setting out the grounds of appeal, however, the appellant discusses the opposition division's interpretation of the claim. This interpretation was decisive for the decision to reject the opposition. The corresponding novelty objection based on documents D1a-c, D10 and D13 was raised in the statement setting out the grounds of appeal. This is sufficient for the appeal to be admissible, irrespective of the fact that the appellant filed additional documents and objections.

Moreover, the fact that the appellant presents a new interpretation of details of the Mirena inserter does not per se run counter to the admissibility of the appeal.

Therefore, the statement setting out the grounds of appeal fulfils the requirements of Rule 99(2) EPC and the appeal is considered admissible.

2. Admittance of D18 and D19

Documents D18 and D19 were filed with the statement setting out the grounds of appeal. The respondent requested that these documents not be admitted because they were late-filed and could have been filed earlier, in particular within the opposition period.

However, as set out clearly below, these documents are highly relevant for the outcome of the appeal. Therefore, the board has admitted them under Article 12(4) RPBA 2007.

3. Main Request - novelty

Document D19 discloses (see column 2, line 23 - column 3, line 50):

a1

An inserter,

a2

having a proximal and distal end,

a3

for inserting and positioning an intra-uterine device (IUD) (15) which is attached to a withdrawal string (22), said inserter comprising:

b1

a plunger (needle 1), having a central longitudinal axis,

b2

configured for slidable mounting of a hollow protective tube (sheath 4 with base 16),

b3

the distal end of the plunger being configured for dismountable connection with the IUD,

b4

which protective tube is configured to slidably cover the IUD;

c1

a handle (thumb piece 3) attached to the proximal end of the plunger (1); and

d1

a longitudinal member (moving arm 10) which extends in the distal direction with respect to the plunger,

d3

and the longitudinal member (10) forms part of the handle (3).

Furthermore, D19 discloses the following features:

d2

The longitudinal member (10) of D19 has a projection (11) for locking into openings (17, 17'). When moved between the openings, the projection 11 slides along the inner surface of the base and is biased towards the inner surface by the elastic loop (8). The longitudinal member (10) thus has a friction contact surface at the end of the projection (11) against which the protective tube (inner surface of the base 16) can frictionally engage, as required by Feature d2.

The respondent argued that in D19 the resistance to sliding of the needle relative to the sheath was described as being achieved by the projection (11), which engages by form fit with the openings (17, 17') in order to immobilise the needle in the sheath (column 2, line 54 - column 3, line 18).

However, D19 implicitly discloses that as long as the projection (11) is not engaged in the openings (17, 17') there is some friction between the projection (11) and the inner surface of the base (16) because the loop (8) biases the arm against the inner surface of the base when the thruster (9) of the thumb piece is not pressed.

d4

When the thruster is pressed, the friction is released. It is within the scope of claim 1 of the patent that the manual actuation of the frictional engagement corresponds to a release of the friction (see e.g. the embodiment shown in Figure 3 of the patent). Therefore, in D19 the frictional engagement of the friction contact surface against the protective tube (base 16) is manually actuatable (releasable) as required by Feature d4.

d5

The frictional engagement of the friction contact surface against the protective tube increases the resistance to sliding of the protective tube relative to the plunger (due to the very nature of a frictional force).

The respondent argued that the claimed function could only be derived from D19 using hindsight. The button (9) was only actuated in the situation shown in Figure 3 of D19 when the projection (11) was being released from the opening (17). In the situation shown in Figure 4, there might be some frictional engagement but there was no manual actuation of the button (9). On the contrary, pressing the button in that situation would prevent the projection (11) from entering the opening (17'), thereby preventing the device from functioning as described in column 3, lines 34-39.

However, claim 1 does not define a method of using the inserter. The claim specifies the technical feature according to which "the frictional engagement of the friction contact surface against the protective tube (base 16) is manually actuatable" (Feature d4).

This feature is intrinsically present in the inserter disclosed in D19, even if no frictional engagement is intended to be used when employing the inserter.

Therefore, the subject-matter of claim 1 of the main request lacks novelty over D19.

4. Auxiliary request 1 - novelty

In claim 1 of auxiliary request 1, the feature has been added according to which the frictional engagement is actuatable "in a radial direction relative to the longitudinal axis of the plunger (102)".

The arm (10) in D19 is moved in a radial direction relative to both the complete inserter and the axis of the needle (1) (see Figures 1-4).

Therefore, the subject-matter of claim 1 of auxiliary request 1 is not novel in view of D19 (Article 54(2) EPC).

5. Auxiliary request 2 - amendments

In auxiliary request 2, Feature d5 has been amended to state that the frictional engagement "prevents" sliding of the protective tube relative to the plunger instead of "increas[ing] the resistance".

As a basis for the added feature the respondent cited page 15, lines 1-8 of the application as originally filed.

This passage describes the advantages of the invention. Among other things it states that "since the invention uses frictional engagement rather than discrete stops, the protective tube (110) can be prevented from sliding relative to the plunger (102) at any desired position".

The fact that the protective tube can be prevented from sliding at any desired position has been omitted when introducing the amendment into claim 1 of auxiliary request 2. The amended claim therefore includes embodiments where the protective tube is prevented from sliding at discrete stops only and not at any desired position. This, however, is explicitly excluded by the cited passage of the description.

Therefore, the subject-matter of claim 1 of auxiliary request 2 extends beyond the content of the application as filed and contravenes Article 123(2) EPC.

6. Auxiliary request 3 - novelty

6.1 Claim 1 of auxiliary request 3 contains two alternative embodiments of the longitudinal members, which formally represent two independent claims. Neither of them is novel (Article 54(2) EPC).

6.2 Second alternative- movable longitudinal member

Compared with auxiliary request 1, the second alternative of claim 1 comprises the additional features according to which "the longitudinal member (150) is configured for radial movement relative to the central longitudinal axis of the plunger (102) and for the application of a force to the protective tube (110) upon manual actuation of the longitudinal member (150)".

In D19, the arm (10) which provides the frictional engagement with the inner surface of the base (16) is configured for radial movement relative to the central longitudinal axis of the needle 1 (Figure 3). Upon release of the force (26) shown in Figure 3 of D19, the arm moves radially outwards and engages the inner surface of the base (16) (Figure 4). Since the base is part of the protective tube, this corresponds to a force being applied to the protective tube. As the release of the manually applied force represents a form of actuating the arm (10), this function falls under the definition of the second alternative of claim 1 of auxiliary request 3.

The respondent argued that in D19 the force was applied only when the arm was released, not when it was actuated.

The term "actuatable" is, however, already used in feature 4d of claim 1, where its meaning includes both the application and release of the frictional engagement (see the discussion regarding the main request). There is no reason to construe the "actuation" of the longitudinal member in the feature added to auxiliary request 3 any differently. Hence "actuation" of the longitudinal member includes the application and the release of a force to the longitudinal member.

Therefore, the second alternative of auxiliary request 3 is not novel in view of D19.

6.3 First alternative - fixed longitudinal member

Compared with auxiliary request 1, the first alternative of claim 1 of auxiliary request 3 comprises the feature according to which "the longitudinal member (150) is in essentially fixed relation to the plunger (102), and is configured to receive a force in an essentially radial direction relative to the central longitudinal axis of the plunger (102), wherein the force is applied by the protective tube (110) upon manual actuation of the protective tube (110)".

Document D18 discloses (see columns 5-8 and Figures 7-10):

a1

an inserter (10),

a2

having a proximal and distal end,

a3

for inserting and positioning an intra-uterine device (IUD) (50) which is attached to a withdrawal string (column 7, line 15), said inserter comprising:

b1

a plunger (rod 31), having a central longitudinal axis,

b2

configured for slidable mounting of a hollow protective tube (11),

b3

the distal end of the plunger being configured for dismountable connection with the IUD (receptacle section 32),

b4

which protective tube is configured to slidably cover the IUD (Figures 9-10);

c1

a handle (33) attached to the proximal end of the plunger; and

d1

a longitudinal member (stems 35) which extends in the distal direction with respect to the plunger and

d3

the longitudinal member (stems 35) forms part of the handle (33).

To release the IUD in D18, the stems (17) of the outer tube are pressed together in a radial direction towards the axis of the plunger (rod 31) (Figures 7-10). Therefore, they can enter the cut-out area (34) between the stems (35), and the tube slides proximally relative to the plunger. The stems (17) are moved from one abutment (36) to another abutment (the bottom of the cut-out area 34). Even though no friction is described between the stems (17) with edges (20) on one side and the stems (35) with edges (37) on the other side, it is inevitably present between the surfaces of these components when the stems (17) are released.

Therefore, D18 also discloses that:

d2

the longitudinal member (stem 35) contains a friction contact surface against which the protective tube (via the stems 17) can frictionally engage,

and that,

d4

the frictional engagement of the friction contact surface against the protective tube (11) is manually actuatable (releasable) in a radial direction relative to the longitudinal axis of the plunger (31) and

d5

wherein the frictional engagement of the friction contact surface against the protective tube (11) increases resistance to sliding of the protective tube (11) relative to the plunger (31).

The longitudinal members (35) in D18 are not movable when the inserter is in use, so they are "in an essentially fixed relation to the plunger 31". Furthermore, the force of the arms (17) is applied to the longitudinal members (35) radially outwardly, so the longitudinal members are "configured to receive a force in an essentially radial direction relative to the longitudinal axis of the plunger". Moreover, when the arms (17) are released, i.e. when the arms forming part of the protective tube are manually actuated, the arms (17) apply the force to the longitudinal members (35).

The respondent referred to the interlocking function of the edges (20) and (37) which carried out the main control function in the inserter in D18. However, this does not exclude the presence of the friction between the components.

Therefore, the subject-matter of the first alternative of claim 1 of auxiliary request 3 is not novel in view of D18.

7. Auxiliary request 3a - novelty

Claim 1 of auxiliary request 3a is identical to the first alternative of claim 1 of auxiliary request 3, which lacks novelty over D18 (see above).

Therefore, the subject-matter of claim 1 of auxiliary request 3a is not novel (Article 54(2) EPC).

8. Auxiliary request 3b - admittance

Auxiliary request 3b was filed on 10 February 2022, i.e. after the summons to oral proceedings.

Compared with claim 1 of auxiliary request 3, the feature has been added according to which "the protective tube (110) can be prevented from sliding relative to the plunger (102) at any desired position".

These additional features represent an amendment to the appellant's case, so the admission of this request is subject to Article 13(2) RPBA 2020. Any such amendments may only be taken into consideration if there are exceptional circumstances, which have been justified with cogent reasons.

According to the respondent, the amendment was a reaction to the Board's preliminary opinion. However, since the Board did not raise any new issues in its preliminary opinion, the opinion did not create any exceptional circumstances which might justify an amendment at this late stage of the proceedings.

Therefore, auxiliary request 3b was not admitted into the proceedings pursuant to Article 13(2) RPBA 2020.

9. Auxiliary request 4 - novelty

9.1 Second alternative

The second alternative of claim 1 of auxiliary request 4 differs from the second alternative of claim 1 of auxiliary request 3 in that it comprises the feature according to which

"the protective tube (110) [has] a central lumen, through which the plunger (102) is disposed, wherein the distal (30) end of the protective tube (110) is configured for receiving the intra-uterine device (IUD) (120)".

This feature is disclosed in D19 where the protective tube (sheath 4) has a central lumen (Figure 1) and the plunger (needle 1) is introduced into the sheath. The distal end (14) of the sheath (4) receives the IUD (15) (column 2, lines 37-40).

The respondent did not provide any concrete arguments to support its assertion that the prior art did not disclose any alternative arrangements for the longitudinal member.

Therefore, the subject-matter of the second alternative of claim 1 of auxiliary request 4 is not novel in view of D19 (Article 54(2) EPC).

9.2 First alternative

The first alternative of claim 1 of auxiliary request 4 differs from the first alternative of claim 1 of auxiliary request 3 in that it comprises the features according to which

a) "the protective tube (110) [has] a central lumen, through which the plunger (102) is disposed, wherein the distal (30) end of the protective tube (110) is configured for receiving the intra-uterine device (IUD) (120)" and

b) "the protective tube further comprises a cuff (116) disposed and fixed at a point along the outside surface of the protective tube (110)".

D18, which discloses all the features of the first alternative of auxiliary request 3, further describes in column 5, lines 20-23 that the instrument "comprises an inserter tube (11) and a coacting rod (31) telescopically positioned in the tube and having mounted therein an intrauterine device (50)" (as shown in Figure 9). This corresponds to the added feature a).

D18 further discloses a "handle (15)" which is disposed and fixed outside the surface of the protective tube (11) (Figures 7 and 8) and therefore corresponds to the cuff as described in feature b).

According to the respondent, the "handle (15)" was only a handle, not a cuff. Technically, however, the "handle (15)" corresponds to the cuff according to claim 1 of auxiliary request 4, which is fixed at a point along the outside surface of the tube.

The respondent did not provide any concrete arguments to support its assertion that the prior art did not disclose any alternative arrangements for the longitudinal member.

Therefore, the subject-matter of the first alternative of claim 1 of auxiliary request 4 is not novel in view of D18 (Article 54(2) EPC).

10. Auxiliary request 5 - novelty

Claim 1 of auxiliary request 5 has been restricted to the second alternative of claim 1 of auxiliary request 4.

Therefore, the subject-matter of claim 1 of auxiliary request 5 is not novel in view of D19 (Article 54(2) EPC).

11. Auxiliary request 6 - novelty

Claim 1 of auxiliary request 6 has been restricted to the first alternative of claim 1 of auxiliary request 4.

Therefore, the subject-matter of claim 1 of auxiliary request 6 is not novel in view of D18 (Article 54(2) EPC).

12. Auxiliary requests 7 and 8 - support by the description

12.1 The independent claims of auxiliary requests 7 and 8 are directed to "method[s] for priming for insertion into the cervical canal an inserter assembly". They include the features of granted dependent claims 5, 7 and 14 as well as 15 or 16, respectively.

Since the respondent did not file an adapted description, the Board had to use the description as granted when deciding whether the the patent could be maintained in amended form.

The description as granted defines the invention as an inserter assembly and it mentions features as being optional, which are present in the independent claims of auxiliary requests 7 and 8.

In detail, paragraph [0011] states that "the present invention relates to an inserter (100) ..." according to claim 1 as granted. This is in contrast with the claims of auxiliary requests 7 and 8, which are directed to a method of priming an inserter. Paragraphs [0019] and [0020] describe the features of a longitudinal groove in the plunger, and of the tube having a central lumen, as being optional. However, these features form part of the invention according to auxiliary requests 7 and 8. Furthermore, paragraph [0025] describes the T-shaped IUD as being optional, and paragraphs [0053] and [0106] state that the inserter of the invention may be used for a wide range of IUDs.

Yet the independent claims identify a specific (T-shaped) IUD as forming part of the invention.

Due to these contradictions between the claims and the description, the claims of auxiliary requests 7 and 8 are not supported by the description as required by Article 84 EPC.

12.2 Under Article 15(3) RPBA 2020, the Board is not obliged to delay any step in the proceedings, including its decision, by reason only of the absence at the oral proceedings of a duly summoned party, who may then be treated as relying only on its written case.

12.3 The Board also refers to the Headnote of T 986/00, published in the Official Journal 2003, page 554:

"According to Article 113(2) EPC, the European Patent Office shall consider and decide upon a European patent only in the text submitted to it, or agreed, by the proprietor of the patent. A proprietor who chooses not to be represented at oral proceedings should ensure that he has filed all amendments he wishes to be considered before the oral proceedings."

Furthermore, according to established case law summarised in CLB V.A.4.5.3(a): "A patent proprietor who prior to oral proceedings files amended claims but no description adapted thereto, and who is not represented at the oral proceedings, cannot 'rely on' the proceedings being continued in writing or the case being remitted to the department of first instance for adaptation of the description (T 181/02, T 109/02, T 651/08, T 776/05, T 2294/08). Hence, a patent proprietor should make sure, that all the required documents, including a description adapted to the claims, on the basis of which the maintenance of the patent could be ordered are on file, so that a decision can be taken by the board at the end of the oral proceedings if a given request is found allowable (T 986/00, OJ 2003, 554; T 181/02; T 109/02; T 776/05; T 651/08)." The Board agrees with this statement.

12.4 In the case in hand, the independent claims of auxiliary requests 7 and 8 contained substantial amendments compared with the claims as granted. Additionally, the parties knew that at the oral proceedings of 9 May 2022 - which the respondent did not attend - only auxiliary requests 7 and 8 would be dealt with.

It can therefore be assumed that the respondent was aware of the fact that the description would have to be adapted to the amended claims if one of these requests were found to be allowable.

However, the respondent did not file an adapted description for auxiliary requests 7 and 8.

12.5 Since no description was filed in support of the independent claims of auxiliary requests 7 and 8 (Article 84 EPC), the patent cannot be maintained on the basis of the these requests.

12.6 Article 13(2) RPBA 2020

The objection concerning the lack of an adapted description was raised for the first time at the oral proceedings. The objection represents an amendment to the appellant's case, so its admission is governed by Article 13(2) RPBA 2020. Any such amendments may only be taken into account if there are exceptional circumstances, which have been justified with cogent reasons.

12.7 In this respect the Board notes that, according to established practice, if an auxiliary request turns out to be allowable during the oral proceedings before the Boards of appeal, its description is normally amended during the oral proceedings before the Board or in separate proceedings once the case has been remitted to the department of first instance. Furthermore, when amended descriptions for auxiliary requests are filed in advance of oral proceedings, they are usually not discussed until the claims of a specific request are found to be allowable during the oral proceedings.

Thus, in this case, the appellant had no reason to comment on the description on file before the oral proceedings.

12.8 This applies even though the respondent was not present at the oral proceedings before the Board.

The respondent informed the Board that it would not be attending oral proceedings shortly before the scheduled date. Nevertheless, since the respondent did not withdraw its request for oral proceedings, it could still have attended. The appellant did not know for sure that the maintenance of the patent would have to be decided on the basis of one of auxiliary requests 7 or 8 in conjunction with the description of the patent as granted until the very day of the oral proceedings when the respondent was not present. It was under these circumstances that the objection of lack of support in the description was raised.

12.9 The appellant cannot be expected to anticipate this course of proceedings and to react by raising objections in advance. Instead, this represents an exceptional circumstance as per Article 13(2) RPBA 2020 and thus allows for objections on that basis.

Therefore, the Board admitted the appellant's objection under Article 84 EPC into the proceedings.