T 2233/15 20-04-2021

Reasons for the Decision

1. Admissibility of E25

1.1 Document E25 was cited for the first time in the grounds of appeal. The board shares the opinion expressed in T 1002/92, referred to by the respondent, that new material should only very exceptionally be admitted into the proceedings since the essential purpose of the appeal procedure inter partes is to give the losing party the possibility of challenging the decision of the first instance rather than to repeat the opposition proceedings.

In that respect, the appeal proceedings are not about bringing an entirely fresh case to the board. This means that a party is not at liberty to bring about the shifting of its case to the appeal proceedings as it pleases, and so compel the board either to give a first ruling on the critical issues or to remit the case to the opposition division. Conceding such freedom to a party would run counter to orderly and efficient appeal proceedings. In effect, it would allow a kind of "forum shopping" which would jeopardise the proper distribution of functions between the departments of first instance and the boards of appeal and would be absolutely unacceptable for procedural economy generally (G 9/91, OJ EPO 1993, 408, point 6 and 18; T 1705/07, not published, point 8.4 of the reasons; T 1067/08, not published, points 7.1 to 7.2).

1.2 In the present case, the attacks based on E25 are completely new. Therefore, their admittance would necessitate either examination of new objections or remittance to the first instance for further prosecution (see for example T 611/90) as requested by the respondent.

1.3 In view of the case-law mentioned above, E25 is not admitted into the proceedings (Article 12(4) RPBA 2007).

Hence, the respondent's request to remit the case to the opposition division should E25 be admitted into the proceedings is moot.

2. Added subject-matter

2.1 In comparison with claim 1 as granted, the subject-matter of claim 1 comprises the supplemental feature according to which:

"said first apparatus (14) is in fluid communication with apparatus (40) including a storage tank adapted for containing media, buffer, reactants and/or other fluids, and including a collapsible plastic bag for containing a liquid".

2.2 This feature is based on paragraph [0062] of the patent application as published which states:

"Optionally, in some embodiments apparatus 14 is in fluid communication with one or more apparatuses 40. For instance, liquid may be transferred 42 continuously or periodically from apparatus 40 to apparatus 14. Apparatus 40 may include, for example, a vessel such as a storage tank adapted for containing media, buffer, reactants, and/or other fluids. A plurality of apparatuses 40 may each contain different media, buffer reactants, and/or other liquids to be transferred to apparatus 14. One or more apparatuses 40 may include disposable components such as a collapsible bad adapted for containing a liquid, the collapsible bag optionally being supported and contained by a reusable support structure."

2.3 Contrary to the opinion of the appellant, it is apparent from this paragraph that the designation of the different media, buffer, reactants, and/or other liquids as being "to be transferred to apparatus 14" is optional since it is stated that "For instance, liquid maybe transferred 42 continuously or periodically from apparatus 40 to apparatus 14". The terms "For instance" and "may be" used in this sentence both indicate the optional nature of this specification.

2.4 Therefore, the requirement in the first sentence that "in some embodiments apparatus 14 is in fluid communication with one or more apparatuses 40" is not inextricably linked to the designation of the liquids as being "to be transferred to apparatus 14.

2.5 Consequently, the subject-matter of claim 1 does not comprise added subject-matter and meets the requirement of Article 123(2) EPC.

3. Inventive step, claim 1

3.1 The Board agrees with the appellant that E6 is a realistic starting out point for assessing the inventive step of claim 1 since it also relates to a system for containing and manipulating fluid substances in a biological process (see E6, abstract).

3.2 The Board agrees with the parties that E6 fails to disclose at least:

(i) a first collapsible bag; and

(ii) a first reusable support structure, adapted for surrounding and supporting the first collapsible bag; and

(iii) an apparatus which is in fluid communication with the first apparatus and which includes a storage tank adapted for containing media, buffer, reactants and/or other fluids, and including a collapsible plastic bag for containing a liquid.

3.3 The technical effect of these distinguishing features is to provide a system which can be set up quickly, without the need for sterilisation and certification of the standard stainless steel or glass bioreactors.

3.4 Therefore, the objective technical problem can be seen as one of how to increase efficiency of a system for containing and manipulating fluid substances in a biological process. Notwithstanding the fact that it would not be related to the technical effects, any attempt to define the technical problem more narrowly by referring to replacing stainless steel or glass containers would be inappropriate since it gives a hint to the solution.

3.5 The respondent submitted that the skilled person would not combine the teachings of E6 and E3 because E6 refers to large scale fermentation whereas E3 is concerned with smaller scale operations. However, this is not persuasive since the apparatus of E3 can also be dimensioned for large scale operations (see E3, paragraph [0031] "The design may also be scalable down to small bench bioreactors volumes and up in excess of 1000 L working volumes").

3.6 Further, the respondent's reasoning that the skilled person would also be dissuaded from combining the teachings of E6 and E3 since the aim of E6 is to provide an environmentally friendly system which runs counter to the idea behind E3 of using disposable items such as plastic bags is not convincing. Whether something is "environmentally friendly" is open to debate. In some circumstances cleaning out tanks and creating waste water and/or solvents is less desirable than using containers which can be safely disposed of and/or recycled.

3.7 The respondent also suggested that since the system of E6 does not require stringent sterilisation there would be no point in modifying the system by employing disposable bags as used in the apparatus of E3. However, the system of E3 is also suitable for non-sterile applications (see E3, paragraph [0009]). Further, as submitted by the appellant the porous filtration element 401 of E3 is optional (see paragraph [0050]).

3.8 Therefore, faced with the above objective problem the skilled person would have consulted E3 and combined its teachings with E6 since it lies in the same technical area of processing biological materials (see paragraph [0002]) .

3.9 E3 also relates to bioreactors comprising a collapsible bag and a reusable support structure, adapted for surrounding and supporting the first collapsible bag (see paragraph [0028], figure 2 and claims 1 and 2). However, although both E6 and E3 indicate that there is a feed line to the system (see E6, figure 1, "Media" line m; and E3, paragraph [0032] "connections" 101e, figure 1B), neither discloses any detail concerning the construction of the apparatus with which the feed line is in fluid communication.

3.10 The appellant submitted that the inclusion of a storage tank comprising a collapsible plastic bag for containing liquid in fluid communication with the first apparatus, as shown for example in E1 (see E1, figure 4, feed container 32), is merely common general knowledge. However, this argument is not persuasive since patent documents cannot normally be used as evidence of common general knowledge and E1 does not in any case disclose the nature of the feed container 32.

3.11 Therefore, the combination of E6 with E3, even taking into account the teaching of E1, does not lead to the subject-matter of claim 1 in an obvious manner.

3.12 E7 like E3, see point 3.9 above, does not disclose any detail concerning the construction of the apparatus which is in fluid communication with the first apparatus (feature (iii)). Hence, for the same reasons the combination of E6 with E7 does not lead to the subject-matter of claim 1 in an obvious manner.

3.13 In conclusion, the subject-matter of claim 1 meets the requirement of Article 56 EPC.

4. Inventive step, method claim 13

4.1 The introductory part of claim 13 reads:

"A method of recovering and recycling solutes or cells from a bioreactor comprising the first collapsible bag (118) of the system (10) of any of claims 1 to 12 while maintaining a substantially constant volume of fluid in the bioreactor,......"

4.2 The appellant submitted that the claim is directed at a method employing any bioreactor comprising the first collapsible bag of any of the systems according to claims 1 to 12. The respondent on the other hand, argued during the oral proceedings, that the skilled person would immediately understand that the claim is for a method in which a system comprising all the features of any of claims 1 to 12 is used.

4.3 As evidenced by the parties' submissions, the introductory part of claim 1 could have perhaps been couched in clearer terms. However, since the wording of claim 13 is identical to claim 15 as granted, an objection of lack of clarity cannot be made (see G 3/14). Therefore, a technically sensible construction of the claim as a whole needs to be reached.

4.4 As argued by the respondent, it appears to the Board that the claim only makes technical sense if all the features of the system according to claim 1 are comprised in the claim. In particular, this is borne out by the use of the definite article when specifying the first apparatus and the second apparatus in the following features:

"allowing a portion of the fluid medium..... into the second inlet of the second external apparatus (18) ..... or through the second internal separation device to the outlet of the first apparatus (14; 66; 100); and

"allowing the separation device of the second apparatus (18) to separate out...........".

4.5 Thus, the skilled person interpreting claim 13 would set aside any purely grammatical construction of the introductory portion and understand that the claim comprises all the features of the system of any of claims 1 to 12 - and not only the first collapsible bag of these systems. In the oral proceedings before the Board, the respondent explicitly confirmed that in their view claim 13 had to be interpreted this way.

4.6 Accordingly, claim 13 also involves an inventive step.