T 0480/11 11-07-2013

Reasons for the Decision

1. Admissibility of appeal

1.1 The respondent requested that the appeal be rejected as inadmissible.

The respondent argued that the appeal was inadmissible since the claim requests were all mutually exclusive in the sense that the patent could not be maintained simultaneously on the basis of the main and any of the auxiliary requests.

It is, however, common practice before the European Patent Office that main and auxiliary requests are submitted as alternative requests and it is therefore self-evident in the statement of grounds of appeal that the requests contained therein are alternative requests rather than requests of equal standing.

Therefore, the board decided that the appeal was admissible.

Auxiliary request 1 (highest-ranking request)

2. Admissibility

2.1 The respondent requested that auxiliary request 1 should not be admitted into the proceedings.

The respondent argued that the claims of auxiliary request 1 were almost identical to the claims of auxiliary request 3, which was filed with the proprietor's letter of 13 September 2010 (hereinafter: "previous auxiliary request 3") and later withdrawn during the oral proceedings before the opposition division. Auxiliary request 1 should not be admitted into the proceedings pursuant to Article 12(4) RPBA since by first withdrawing this request and later re-filing it during appeal, the appellant had tried to prevent the taking of a decision by the opposition division on this request.

2.2 The board does not find the respondent's argument persuasive. Firstly, previous auxiliary request 3 was not identical to auxiliary request 1 since independent claim 15 of this previous request is not present in auxiliary request 1. This means that the withdrawal of previous auxiliary request 3 does not prove that the opponent tried to prevent the taking of a decision on auxiliary request 1. Secondly, the claims of auxiliary request 1 are an assembly of claims already decided upon by the opposition division, namely claims 1 to 8 of the then auxiliary request 1 and claims 9 to 14 of the then main request. Thus the appellant has not prevented the taking of a decision on these claims.

2.3 The respondent furthermore argued that the function of appeal proceedings was to review the opposition division's decision, so the appellant could not start the appeal proceedings with a "brand new" auxiliary request 1.

As set out above (point 2.2) however, auxiliary request 1 is not entirely new but simply an assembly of claims from the main request along with auxiliary request 1 decided upon by the opposition division.

2.4 The respondent finally argued that the appellant had constantly filed and withdrawn requests during the opposition and appeal proceedings and that this constant shifting of requests constituted an abuse of proceedings.

The board did not concur however: while the appellant may not have presented its claim requests in the most efficient way in terms of procedural economy, this in itself cannot be considered to represent a procedural abuse.

2.5 The board therefore decided to admit auxiliary request 1 into the proceedings.

3. Sufficiency of disclosure

3.1 Claim 1 refers to a culturally modified lactic acid bacterial cell selected from the group consisting of Lactococcus spp. and Leuconostoc spp. that contains at least 0.1 ppm on a dry matter basis of cytochrome d (for the exact wording of claim 1, see point X above).

3.1.1 As set out on page 3, line 53 to page 4, line 8 of the opposed patent, the expression "culturally modified lactic acid bacterial cell" in claim 1 relates to a cell of a lactic acid bacterium which has been cultured by fermentation in an appropriate nutrient medium in which an effective amount of at least one porphyrin compound is present. According to page 4, lines 35 to 46 of the opposed patent, it is due to this presence of a porphyrin compound during the culturing that the cells contain at least 0.1 ppm of cytochrome d.

3.1.2 The respondent argued on the basis of D11 and D12 that not all strains of the genera of claim 1 (Lactococcus spp. or Leuconostoc spp.), which have been cultured in the presence of a porphyrin compound, contained the required amount of cytochrome d.

D11 describes the cultivation of eight different strains in the presence of haemin (a porphyrin compound), the eight strains including two Lactococcus strains, namely Lactococcus lactis HP and CHCC373 and one Leuconostoc strain, namely Leuconostoc mesenteroides DSM20848. D12 refers to an analysis in which the cytochrome d amount present in the thus-cultured strains was determined.

It follows from D12 that after the culturing in the presence of haemin, one of the two lactococcus strains, namely Lactococcus lactis HP, and the only Leuconostoc strain, namely Leuconostoc mesenteroides DSM20848 did not contain any cytochrome d, not even the minimum amount of cytochrome d as required by claim 1. This was not disputed by the appellant.

These experimental results thus prove that not all strains falling under the bacterial genera Lactococcus spp. and Leuconostoc spp. of claim 1 can produce the required amount of cytochrome d when cultured in the presence of a porphyrin compound. For the invention underlying claim 1 to be sufficiently disclosed, the skilled person must therefore be able to select without undue burden suitable strains out of the strains belonging to the genera of claim 1 that produce the required cytochrome d amount when cultured in the presence of a porphyrin compound.

3.2 There is no evidence that the skilled person is able to do so on the basis of his common general knowledge.

3.3 It must therefore be examined whether there is any guidance in the opposed patent on the basis of which the skilled person is able to identify suitable strains without undue burden.

The opposed patent discloses only one specific bacterial strain, namely Lactococcus lactis CHCC373, and does not contain any information on what other strains could be used to obtain the required amount of cytochrome d.

As set out by the respondent during the oral proceedings, hundreds of different strains fall under the genera of claim 1. Hence, the skilled person has to take each of these hundreds of strains, except for the one CHCC373 strain exemplified in the patent, and check which, if any, amount of cytochrome d each of these strains produces when cultured in the presence of a porphyrin compound. To do so, hundreds of experiments must be performed. In each of these experiments, a fermentation medium must be inoculated with the cells of one particular strain, a porphyrin compound must be added, the cells must be grown in the fermentation medium, the cytochrome d must be isolated in a multiple reslurrying-centrifugation sequence and after the last centrifugation step, the obtained supernatant must be analysed by means of a spectrophotometer to determine the amount of cytochrome d contained therein (page 9, lines 47 to 51 and page 13, line 14 to page 14, line 24 of the opposed patent).

All that the opposed patent thus provides is an invitation to carry out a research programme and to find out by trial and error in hundreds of laborious experiments which strains provide the required cytochrome d amount. This represents an undue burden, so the requirement of sufficiency of disclosure is not fulfilled (see for instance T 1063/06; OJ 2009, 516; headnote II and T 809/07 of 15 April 2010, not published in OJ EPO, headnote).

3.4 The appellant did not dispute that trial and error experiments would be necessary in order to identify suitable strains. According to the appellant, the necessity of such trial and error experiments does however not amount to an undue burden and hence does not lead to insufficiency of disclosure, in particular in the field of biotechnology.

The board acknowledges that the need for some trial and error as such does not necessarily imply insufficiency of disclosure if the patent provides adequate information leading directly to success through the evaluation of initial failures and, therefore, only a few attempts are required to transform failure into success (see T 326/04 of 12 December 2006, not published in OJ EPO, point 1.3). It is however exactly this information that is missing in the opposed patent, which is why the skilled person must test, by way of trial and error, each and every one of the hundreds of available strains falling under the genera of claim 1 (except for the one strain Lactococcus lactis CHCC373 exemplified in the patent).

Furthermore, the issue of sufficiency of disclosure is a question of fact that has to be decided on a case-by-case basis (see T 694/92; OJ EPO 1997, 408; point 5) and on no account does the need for trial and error experiments automatically lead to insufficiency of disclosure in the field of biotechnology. Yet the boards have deemed there to be insufficiency of disclosure in certain biotechnology cases where trial and error experimentation was needed. Reference is made to T 1456/06 of 31 March 2011 (not published in OJ EPO), where, in relation to a claim directed to the use of an immunogenic fragment in the preparation of a certain vaccine, it was considered that "identifying immunogenic fragments of the telomerase protein suitable for the manufacture of a vaccine by a trial and error procedure constitutes an undue burden to a person skilled in the art" and that the requirement of sufficiency of disclosure was therefore not fulfilled (point 39, emphasis added).

3.5 The appellant further argued that the burden of proof as regards sufficiency of disclosure was on the respondent rather than the appellant and that the respondent had "cherry-picked" in its experiments those strains that did not work.

However, by submitting the experimental data D11 and D12, the respondent had discharged his burden of proof, so that it was up to the appellant to present refuting evidence and arguments. The appellant has however not commented at all in the present written appeal proceedings on the respondent's insufficiency objections and has not provided any experimental counter-evidence to support its allegation of cherry-picking. The only "evidence" referred to by the appellant when discussing auxiliary request 1 during the oral proceedings was the prior art document D4 that allegedly showed the possibility of producing the required amount of cytochrome d with culturally modified Lactococcus and Leuconostoc strains. However, this allegation runs counter to the appellant's own statement on page 5 of the statement of grounds of appeal that the cells in D4 "are not culturally modified cells, since the hemin is added after the culturing phase" and that "a quantification of cytochrome d is not derivable from D4".

3.6 In view of the above, the requirement of sufficiency of disclosure of the invention underlying claim 1 is not fulfilled. Auxiliary request 1 is therefore not allowable.

New auxiliary request 2

4. Request to hear Mr Johansen

4.1 Claim 1 of new auxiliary request 2 differs from the claim 1 of auxiliary request 1 in that the cell is now restricted to the species Lactococcus lactis (for the exact wording of claim 1 of new auxiliary request 2, see point X above).

4.2 During the discussion of the admissibility of new auxiliary request 2, the appellant requested that Mr Johansen be allowed to speak about "their experience of repeating the claimed invention with other strains of Lactococcus lactis and their observed success rate in providing Lactococcus strains fulfilling the requirements of claim 1 of the newly presented auxiliary request 2".

4.3 The board is aware that the appellant referred to Mr Johansen as a technical expert in its letter of 13 June 2013 and requested that Mr Johansen be allowed to provide comments on any technical issue relating to the claimed invention that might come up during the hearing. However, the subject on which Mr Johansen intended to speak according to the appellant's request as specified during the oral proceedings was not simply a technical issue but in fact an event in the past, namely the performance of experiments and the results obtained thereby, which had taken place at the appellant's laboratory. So the appellant's request was actually directed to hearing Mr Johansen as a witness rather than as a technical expert.

4.4 The appellant argued that the proprietor had made a statement during the opposition proceedings similar to the one which Mr Johansen was going to present in appeal. The appellant referred to the passage of the opposition division's decision in the second part of the fifth paragraph on page 8 of the decision, which reads as follows

"... P argued that the majority of the strain produced by Chr. Hansen and tested in the laboratory produced cytochrome d, and although some trial and error might be necessary to select the suitable strains, no undue burden was left to the skilled person as the results obtained - with producing and non-producing strains - were repeatable."

The proprietor's statement referred to in the opposition division's decision that the majority of strains produce cytochrome d had been challenged by the respondent in its response to the statement of grounds of appeal (letter of 9 September 2011). In this letter the respondent had specifically stated that "[H]owever, none of the other strains/species tested produced cytochrome d. Notably, even the other strain of Lactococcus lactis tested, namely strain HP, did NOT produce cytochrome d."

So at the latest upon receipt of this letter, the appellant must have been aware that its statement during the opposition proceedings may not be sufficient to prove that the majority of strains lead to the required cytochrome d amount, and that thus more evidence would be required as regards the success rate obtained with these strains. Nevertheless, the appellant chose to wait until the latest possible point in time during the present appeal proceedings to offer further evidence in the form of a "witness statement".

If the witness had been allowed to speak, the respondent would have had to be given sufficient opportunity to challenge the witness statement and it would have been necessary to adjourn the oral proceedings. Therefore, the board decided not to allow the appellant's request to hear Mr Johansen, pursuant to Article 13(3) RPBA.

5. Admittance of new auxiliary request 2

5.1 New auxiliary request 2 was filed during the oral proceedings before the board. The appellant requested that this request be admitted into the proceedings because it had been confronted with new case law during the oral proceedings before the board and that the filing of new auxiliary request 2 had become necessary as a reaction thereto. Furthermore the restriction of the bacterial cells to the Lactococcus lactis species clearly overcame the insufficiency objection raised with regard to auxiliary request 1 such that new auxiliary request 2 was clearly allowable.

5.2 The board does not share the appellant's view that the appellant has been confronted with "new case law". On the contrary, the requirement applied by the board that sufficient guidance must be available to enable the skilled person to obtain the claimed subject-matter without undue burden is a well-established criterion as regards sufficiency of disclosure and certainly does not constitute "new case law" (see the decisions cited in point 3.3 above). Furthermore, even if, for the sake of argument, this requirement were to be considered to be "new case law", the possibility that this "new case law" would be applied must have been apparent to the appellant at the latest upon receipt of the respondent's letter of 9 September 2011, where the respondent on page 36 explicitly referred to this requirement when quoting the Guidelines for Examination. Furthermore, this requirement was even reiterated in the board's communication of 21 December 2012 where it was stated that "[I]t has to be discussed whether the required cytochrome d amount can be obtained with any starter culture organisms as covered by claim 1 and if not, whether the skilled person is able to select, without undue burden, those starter culture organisms that result in the required cytochrome d amount." So, this allegedly "new case law" cannot have come as a surprise to the appellant.

It is also not true that due to the restriction of the bacterial cells to the Lactococcus lactis species, the previous insufficiency objection has been clearly overcome. More specifically, as has been set out above (point 3.1.2), the respondent's experiments prove that one out of two tested Lactococcus lactis strains does not have the ability to produce the required cytochrome d amount. It is thus doubtful whether due to the restriction of the cells in claim 1 to the Lactococcus lactis species, undue burden would no longer be required to determine appropriate lactococcus lactis strains.

Finally, the parties would have had to be given an opportunity to address the question of whether an undue burden would still be required to carry out the invention underlying restricted claim 1 and, if needed, to file further evidence in this regard. The necessity for such opportunity is in fact underlined by the respondent's request to hear Mr Johansen. This is thus not only a change of the appellant's case, but it would also not have been possible to come to a final decision without adjourning the oral proceedings.

Therefore the board decided not to admit new auxiliary request 2 into the proceedings (Article 13(1) and (3) RPBA).

Auxiliary requests 2 to 5

6. Sufficiency of disclosure

In the same way as auxiliary request 1, each of auxiliary requests 2 to 5 contains a claim 1 in which the bacterial cell is a bacterial species selected from the group consisting of Lactococcus spp. and Leuconostoc spp. and which stipulates that the cell must contain at least 0.1 ppm on a dry matter basis of cytochrome d (see point X above). Therefore the insufficiency objection raised with regard to auxiliary request 1 equally applies to each of auxiliary requests 2 to 5. These requests are thus not allowable either.