T 1779/17 22-02-2022

Reasons for the Decision

1. Admissibility of the opposition

1.1 The formal requirements for filing a notice of opposition are set out in Article 99(1) EPC and Rule 76 EPC. It is stipulated in Rule 76(2)(a) EPC in view of Rule 41(2)(c) EPC that a notice of opposition must contain, among other things, the name of the opponent.

1.2 In the notice of opposition as originally filed, prior to its correction, the two different opponent names indicated in Form 2300E and in the accompanying letter do cast doubt as to the identity of the opponent.

1.3 The opponent requested a correction of the opponent's name and filed supporting evidence in the Annex of 15 December 2016 before the opposition division. The opposition division allowed the request and admitted the supporting evidence, holding that it was prima facie relevant (point 11.1 of the impugned decision). Hence, the request and the supporting evidence are to be considered by the board of appeal (Article 12(2) RPBA 2020).

1.4 Mistakes in any document filed with the European Patent Office may be corrected on request pursuant to Rule 139, first sentence, EPC. An allowable correction pursuant to Rule 139 EPC must introduce what was originally intended, must be filed without delay and must have retrospective effect, as set out in point 37 of the Reasons of G 1/12, which summarises the principles applying to corrections pursuant to Rule 139, first sentence, EPC. These principles likewise apply when assessing whether a correction of the opponent's name pursuant to Rule 139, first sentence, EPC is allowable.

1.5 For the reasons presented below, the board shares the opposition division's findings as regards the request for correction.

1.5.1 The original intention was not immediately apparent, and therefore the opponent as the requester bore the burden of proof.

Part of the evidence submitted on 15 December 2016 in support of the request for correction, namely the e-mails, letters and invoices dated between 5 August 2014 and 12 January 2015, reflects an exchange between Vetter Pharma-Fertigung GmbH & Co. KG and Gleiss & Große relating to surveillance of the impugned patent and searches for relevant prior art in preparation for an opposition. This part of the evidence confirms that Vetter Pharma-Fertigung GmbH & Co. KG instructed Gleiss & Große to carry out those tasks.

More importantly, the minutes of a telephone conversation between Ms. Nusseleit from Vetter Pharma-Fertigung GmbH & Co. KG and Gleiss & Große at 12:45 on 5 February 2015, containing in the first line "N: file opposition" ("N: Einspruch einlegen" in the filed version in German), together with the subsequent letter and invoice from Gleiss & Große to Ms. Nusseleit of Vetter Pharma-Fertigung GmbH & Co. KG dated 16 February 2015 including, among other things, the line item "Preparation of a notice of opposition and filing with the European Patent Office" ("Ausarbeitung eines Einspruchsschriftsatzes und Einreichung beim Europäischen Patentamt" in the filed version in German), confirm that Gleiss & Große prepared and filed the opposition on the instructions of Vetter Pharma-Fertigung GmbH & Co. KG.

This evidence, together with the indication at the beginning of the letter accompanying the notice of opposition that the opposition was filed in the name of and on behalf of Vetter Pharma-Fertigung GmbH & Co. KG ("Namens und im Auftrag der Vetter Pharma-Fertigung GmbH & Co. KG" in the filed version in German), confirms to the board's satisfaction that the true intention was to file the opposition in the name of Vetter Pharma-Fertigung GmbH & Co. KG.

1.5.2 At the oral proceedings before the opposition division, the opponent submitted auxiliary requests to have both opponents registered or just "MAPAL Fabrik für Präzisionswerkzeuge Dr. Kress KG" (point 2.1 of the minutes of the oral proceedings before the opposition division).

These auxiliary requests constituted fallback positions in the event the opposition division did not grant the opponent's main request for correction. They do not cast any doubt on the conclusion above regarding the true intention when the notice of opposition was filed.

1.5.3 Furthermore, the request for correction and the supporting evidence were filed on the day before the oral proceedings before the opposition division. This does not represent an undue delay because it was only on this day that the EPO informed the opponent of the mismatch in the opponent's names in the notice of opposition. No doubts as regards the identity of the opponent had been raised before. The request for correction was thus filed without delay.

1.5.4 Under these circumstances, it is irrelevant whether the error in Form 2300E may have had consequences on strategic decisions made by the proprietor.

1.5.5 In summary, it was possible to establish which party intended to file the opposition before the expiry of the opposition period. The request for correction pursuant to Rule 139, first sentence, EPC is thus allowable as it complies with the principles as set out in G 1/12, Reasons 37.

1.6 It follows that the opposition is admissible as it complies with Article 99(1) EPC and Rule 76 EPC.

1.7 In view of this conclusion, there is no need to consider the conditional request by the opponent regarding questions to be referred to the Enlarged Board of Appeal pursuant to Article 112(1) EPC.

2. Third-party observations

The third-party observations were only filed in the appeal proceedings. Third parties cannot be granted rights extending beyond those of the parties to the proceedings (see Case Law of the Boards of Appeal, 9th edition 2019, III.N.4.4.1).

The opponent explicitly endorsed the third-party observations. The proprietor objected to their admittance into the appeal proceedings. Rather than deciding on the admittance of the third-party observations in their entirety, admittance is separately addressed in the following sections for each of the issues raised in the third-party observations.

3. Main request - patent as granted

3.1 Article 100(b) EPC

In the third-party observations it was submitted that the patent did not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (Article 100(b) EPC).

No ground for opposition according to Article 100(b) EPC had previously been raised. The proprietor did not agree with the introduction of this new ground for opposition. Pursuant to G 9/91, Reasons 18, this ground cannot be introduced into the appeal proceedings.

3.2 Novelty

The objection of lack of novelty of the subject-matter of claim 1 as granted over GG6, submitted by the third party, is admitted into the appeal proceedings because it relates to an issue decided upon by the opposition division and substantiates why the opposition division allegedly erred in its decision.

Paragraph [0093] of GG6 discloses "means for detecting shaking movements", without further specifying the means. Contrary to the third party's view, it is conceivable for means other than an inertial sensor to be used for this purpose, e.g. an image sensor detecting shaking movements by image analysis. Moreover, the meaning of "inertial sensor" in claim 1 is not affected by whether the preferred inertial sensor indicated in the patent specification is able to carry out the function defined in claim 1. Hence, GG6 does not disclose an "inertial sensor" as required by claim 1 and therefore the subject-matter of claim 1 is novel over GG6 for this reason alone.

3.3 Inventive step

3.3.1 The background of the invention as described in paragraph [0001] of the patent specification indicates that insulin pens for insulin users are convenient and easy to use. When a user manually shakes an insulin pen, the actual motion of the pen will not be exclusively along the longitudinal axis but will include some rotational or lateral components. The interpretation submitted by the proprietor that the detection in claims 1 and 7 was restricted to a purely linear motion along the longitudinal axis would result in practice in virtually no shaking movement "along the longitudinal axis" being detected. This argument therefore cannot be accepted because it is not technically sensible and it does not take the disclosure of the patent into account.

3.3.2 The proprietor contested the opposition division's finding that the subject-matter of claim 1 was not inventive over GG6 in view of common general knowledge.

3.3.3 Document GG6 discloses a modular medication delivery device such as a pen injector ([0010]-[0011]). Among the replaceable modules which can be part of the medication delivery device, GG6 describes in each of paragraphs [0041] and [0093] a replaceable module containing "means for detecting shaking movements of the medication delivery device and means for providing an alarm signal indicating that a certain amount of shaking movements has been performed to ensure a proper mixing of the constituents of the medication cartridge". Document GG6 likewise discloses processing means (paragraph [0024]) disposed in the housing and operatively connected to a power source and memory (paragraph [0024], see also Figures 3-4 and paragraphs [0076]-[0078]).

3.3.4 Claim 1 is novel over GG6 in that GG6 does not disclose that:

1) the sensor is an inertial sensor and the microprocessor is able to perform the determination from output signals of the inertial sensor; and

2) a predetermined number of shaking movements back and forth along the longitudinal axis can be determined by the microprocessor.

3.3.5 The first distinguishing feature has the effect of providing a specific technical implementation of the means for detecting the shaking movements in GG6. The second distinguishing feature has the technical effect of restricting the counting to the shaking movements along the direction which contributes most to the mixing of the drugs.

3.3.6 The proprietor argued that it was the relationship between the microprocessor and the inertial sensor which enabled the technical effects and which addressed the problem of how to improve the reliability of the mixing of the medicament to ensure a more effective drug delivery.

The board has a different view. The determination by the microprocessor from output signals of a sensor as defined in claim 1 could likewise occur with signals of a sensor other than an inertial sensor, e.g. with an image sensor as referred to within the novelty analysis. Thus, the distinguishing features have no synergistic effect and it has to be established which problem is solved by each feature and whether each feature is separately obvious in the light of the prior art, using so-called "partial problems".

The first problem can be regarded as how to implement the means for detecting the shaking movements of GG6. The second problem can be regarded as how to determine whether the constituents of the medication cartridge in the drug delivery pen have been properly mixed.

3.3.7 The person skilled in the art starting from GG6 and faced with the first problem needs to choose a specific technical implementation of the "means for detecting shaking movements" disclosed in paragraph [0093], an issue which necessarily arises when carrying out the teaching of GG6.

It is well known that electronic inertial sensors can be used to detect movements such as shaking movements, allowing the subsequent counting thereof before the triggering of an alarm as described in paragraph [0093] of GG6. Moreover, if the use of other types of sensors is conceivable, an electronic inertial sensor would represent an obvious choice for the implementation, which would be used in GG6 by the person skilled in the art without inventive effort. In this regard, reference is made by way of example to GG9 (page 3, lines 29-30; page 4, lines 11-14; and page 6, lines 7-10).

3.3.8 As regards the second problem, the drug delivery pen of GG6 has a longitudinal housing and a longitudinal, cylindrical medication cartridge (see cartridge 12 in Figure 2 and [0074]); their respective longitudinal axes are parallel to each other.

It is part of common general knowledge that mixing the constituents of an elongated component such as the medication cartridge of the pen of GG6 is mainly achieved by back and forth shaking movements along its longitudinal axis. In turn, shaking movements in a transverse direction provide only a minor contribution to the mixing.

In order to improve the determination as to whether the constituents of the medication cartridge in the drug delivery pen of GG6 have been properly mixed, the person skilled in the art using their common general knowledge would thus implement the determination of the number of shaking movements of GG6, focusing on those shaking movements which substantially contribute to the mixing, i.e. those along the longitudinal axis of the medication cartridge and thus also of the housing, since they are parallel to each other.

3.3.9 In summary, the person skilled in the art starting from GG6 and faced with the problems above would arrive, using their common general knowledge, at a drug delivery pen anticipating the subject-matter of claim 1 without using inventive skill.

3.4 It follows that the main request is not allowable for lack of inventive step of the subject-matter of claim 1 (Article 56 EPC).

4. Auxiliary request 1

4.1 Inventive step over GG7 and common general knowledge

In the third-party observations, an objection of lack of inventive step of the subject-matter of claim 1 in view of GG7 and common general knowledge was raised.

Auxiliary request 1 corresponds to the version maintained by the opposition division which was filed on 16 November 2016, i.e. one month prior to the oral proceedings before the opposition division. This inventive-step objection defines a new line of attack not raised during the opposition proceedings and not addressed in the impugned decision. The board has decided not to admit this objection into the proceedings under Article 12(4) RPBA 2007.

4.2 Inventive step over GG6 and GG4

4.2.1 The opponent submitted that claims 1 and 7 did not require the same inertial sensor to be used to determine whether the housing had been shaken back and forth a predetermined number of times along the longitudinal axis and to determine whether the housing was oriented topmost and generally vertically with respect to the ground in a priming position. The opponent also alleged that a German court in infringement proceedings would most likely regard a pen device with two different inertial sensors carrying out the different functions as falling under the scope of protection of claims 1 and 7.

The board notes that claims 1 and 7 respectively introduce "an inertial sensor" and subsequently refer to it by using a definite article before the term "inertial sensor" (e.g. "from output signals of the inertial sensor"). Hence, each of the independent claims 1 and 7 defines a single inertial sensor which serves two different purposes. The board additionally notes that this conclusion is also supported by the description of the patent specification: the first few words of paragraph [0046], namely "The inertial sensor is also utilized to ..." (underlining added by the board), make it clear that the same inertial sensor is used for both functions.

The submission by the opponent about how a German court in infringement proceedings would interpret the claim relates to an issue which is not at stake in the present case. Infringement proceedings are different from opposition appeal proceedings before the EPO concerned with the patentability of the subject-matter of a claim in view of the prior art.

The opponent submitted that the wording used in the independent claims did not require a microprocessor configured to determine "whether the housing has been shaken ...", but rather merely a processor which could be programmed to carry out such a determination, i.e. any programmable microprocessor.

The fact that the microprocessor in claim 1 "is able to determine ..." defines a functional feature of the microprocessor. In the context of a data processing function carried out by an entity such as a microprocessor, this functional feature is construed as the microprocessor not just being able to carry out the function but being adapted to carry it out as is, in agreement with established EPO practice when assessing means-plus-function features (see T 410/96, Reasons 5-10, and T 96/12, Reasons 4; see also Guidelines for Examination in the EPO, F-IV, 4.13.2, 3rd paragraph, as well as F-IV, 3.9.1). For the same reasons, claim 7 is likewise construed as requiring the necessary configuration to carry out the determination described.

4.2.2 It is common ground that the feature added to claims 1 and 7 of auxiliary request 1, i.e. the microprocessor being configured to determine from output signals of the inertial sensor whether the pen housing including the cartridge is oriented topmost and generally vertically with respect to the ground in a priming position, is not disclosed in document GG6 and thus constitutes an additional distinguishing feature.

4.2.3 It was submitted both by the opponent and by the third party that the features distinguishing the subject-matter of claims 1 and 7 from GG6 each solved the partial problems of proper mixing and proper priming position detection and that GG4 taught in column 3, lines 13-17, a priming detection facility using an accelerometer (i.e. an inertial sensor), and therefore the feature added to claims 1 and 7 could not lead to an inventive step either. The board has reached a different conclusion, for the reasons presented below.

4.2.4 GG6 uses a modular design. The idea in GG6 is that key components, such as injection mechanics, processor, memory, battery, etc., are provided in a basis module in order to avoid duplication of key components (see paragraphs [0016]-[0018], [0050]-[0051], [0057] and [0074]-[0078]). The basis module is then combined with one or more replaceable modules from a collection of replaceable modules in order to provide an individual pen tailored to the functions needed by a user (see e.g. paragraphs [0009], [0012]

and [0053]-[0054]). Each replaceable module in the collection of replaceable modules is adapted to cooperate with the basis module to provide a specific function (see paragraphs [0010] and [0052] of GG6).

4.2.5 The teaching in paragraph [0016] of GG6 that the device is to be customised while avoiding the duplication of key components refers to the provision of a basis module containing common resources, as indicated above. It does not imply that an identical sub-component - such as an inertial sensor - cannot be present in two different replaceable modules. This is confirmed by the list of replaceable modules disclosed in GG6, in which different modules include, e.g., a loudspeaker (see paragraphs [0035]-[0036]) or means for providing an alarm (see paragraphs [0040]-[0041]).

4.2.6 The arguments that a module combining proper mixing detection and priming detection would also be considered and that the replaceable modules disclosed in paragraphs [0037]-[0042] of GG6 show different functionalities being provided in the same replaceable module are not convincing.

GG6 explicitly describes in paragraphs [0010] and [0052] each module being adapted to provide a specific function. Each of the replaceable modules disclosed in paragraphs [0029]-[0047] deals with a specific function which is presented in the corresponding paragraphs [0081]-[0099]. For example, "monitoring and controlling the temperature of the medication cartridge and its contents" refers to a single function, namely "ascertaining that the currently loaded medication is usable, irrespective of the temperature that the device experiences" (see paragraph [0090]). The modules of paragraphs [0040]-[0041] also serve only to ensure a proper mixing of the constituents of the medication cartridge, even if sub-components for counting the number of shaking movements and for providing an alarm signal are needed for this function.

Medication mixing and pen priming are two different functions relating to two different preparatory steps of the drug delivery pen, and therefore providing both in the same replaceable module would go against the teaching of GG6 of having each module adapted to provide a specific function.

4.2.7 Hence, the person skilled in the art starting from the modular pen injector of GG6, even if faced with the partial problems mentioned above and a desire to implement a priming detection facility following the teaching of GG4, would have provided separate replaceable modules for proper mixing detection and for priming detection. That is, the two functionalities would not have been provided in the modular pen injector of GG6 in the same replaceable module using the same inertial sensor, and therefore the person skilled in the art would not have arrived at a device anticipating the subject-matter of claims 1 or 7.

4.2.8 Document E1 was filed to support the ground of opposition of insufficient disclosure and was referred to in the third-party arguments against inventive step. More specifically, it was argued that an accelerometer such as the one shown in E1 would be an inertial sensor. Such a sensor could be used for sensing proper priming. However, this argument does not address the issue of why the person skilled in the art should use the same module for both functionalities.

4.2.9 It follows that the objection of lack of inventive step (Article 56 EPC) over GG6 and GG4 does not prejudice the maintenance of the patent on the basis of auxiliary request 1.

4.3 There were no further objections against auxiliary request 1. Since auxiliary request 1 corresponds to the request found to meet the requirements of the EPC by the opposition division in the appealed decision, there is no reason to set aside that decision.