T 1100/10 (Detergent Bacillus lentus subtilisin protease egg stains/BASF) 18-03-2014

Admissibility of the Main Request and of Auxiliary Requests 1 to 3

1. The Main Request and Auxiliary Requests 1 to 3 were filed at the beginning of the oral proceedings before the board and thus, outside the time limit set by the board in its communication pursuant to Article 15(1) RPBA, namely one month before the oral proceedings (cf. point VI supra).

2. The filing of these requests represents an amendment of appellant I's case. According to Article 13(1) RPBA, any amendment to a party's case after it has filed its Grounds of Appeal may be admitted and considered at the board's discretion. The Main Request and Auxiliary Requests 1 to 3 are entirely new in the proceedings, none of them has been filed in the procedure before the opposition division, and no convincing reasons have been provided to explain why they could not have been filed at an earlier stage of the proceedings, for instance at the onset of the appeal procedure, or at least in direct response to the board's communication (Article 12(4) RPBA). Thus, the admissibility of these requests into the appeal proceedings is left to the board's discretion as conferred to it by Articles 12(4) and 13(1) RPBA.

3. In the communication pursuant to Article 15(1) RPBA, the board has considered that appellant II's objection under Article 84 EPC, raised against claim 1 of the requests then on file, was relevant (cf. points 26.1 to 26.4 of the board's communication). According to the board's preliminary opinion, the wording "a mutant Bacillus lentus DSM 5483 subtilisin protease" in claim 1 of these requests had to be interpreted broadly and, accordingly, the claim was open to the objections under Articles 54 and 56 EPC (cf. points 31-32 and 34 of the board's communication).

4. Claim 1 of the present Main Request reads "a mutant Bacillus lentus DSM 5483 subtilisin protease", which is "characterized by at least one amino acid alteration" that has a specific effect (reduced positive charge or increased negative charge) in the region of the substrate binding pocket and wherein said amino acid alteration is "L211D according to the counting of SEQ ID NO.22" (cf. point IX supra).

Contrary to appellant I's assertion, the board, as stated in its communication, does not see claim 1 to be limited to the specific alkaline protease from Bacillus lentus DSM 5483 (BLAP) with sequence SEQ ID NO. 22. Rather, SEQ ID NO. 22 is cited in claim 1 as a counting reference only, with the effect that claim 1 embraces other subtilisin proteases from B. lentus DSM 5483. Although according to claim 1 one amino acid alteration must be L211D, neither the absolute number nor the type of "amino acid alterations" that might additionally be present is defined. These alterations do not necessarily have to be substitutions but may be other types of alterations as far as they fulfil the required structural feature, namely to give rise to "a reduced positive charge or an increased negative charge in the region of the substrate binding pocket".

In accordance with the established case law of the Boards of Appeal, there is no reason for the board to interpret claim 1 in a narrow manner (cf. "Case Law of the Boards of Appeal of the EPO", 7th edition 2013, I.C.3.8, page 114). The fact that neither the structure of the subtilisin protease (SEQ ID NO) on which the alterations are performed, nor the number and type of possible additional alterations are clearly defined in claim 1, renders the scope of this claim unclear and ambiguous, which, as stated in the board's communication, has to be considered when examining the requirements of Articles 54 and 56 EPC. The Main Request, filed at the oral proceedings, does not overcome the objections already raised in the board's communication against former requests.

Moreover, a so-called "disclosed disclaimer", i.e. a disclaimer excluding subject-matter which originally was disclosed as part of the invention, has been introduced into claim 1 of the Main Request ("except a mutant described by SEQ ID No. 17 or SEQ ID NO. 18") (cf. point IX supra). This disclaimer is new in the proceedings and its introduction requires the board, for the first time in the procedure, to examine whether the criteria defined in decision G 2/10 (OJ EPO 2012, page 376) are fulfilled. The introduction of the disclaimer clearly represents a new issue and leads to a fresh case.

5. Claim 1 of Auxiliary Request 1 differs from claim 1 of the Main Request by the deletion of the terms "at least". The disclaimer of the Main Request is not present (cf. point X supra). The term "at least", defining the number of alterations contained in the claimed mutants, has been present in all claim requests that had been on file so far through the entire procedure.

If the deletion is understood as limiting the scope of claim 1 to a specific mutant of the B. lentus DSM 5483 subtilisin protease (BLAP, SEQ ID NO. 22) characterized by a single mutation or amino acid alteration in the region of the substrate binding pocket (L211D), then there exists a clear contradiction with claim 2, which defines the subtilisin protease mutant of claim 1 as being described by SEQ ID NO. 16. Sequence SEQ ID NO. 16 characterizes the subtilisin protease mutant F49 which, apart from the amino acid alteration L211D, contains five other mutations (S3T+V4I+A188P+V193M+V199I) that distinguish the M131 BLAP mutant from the wild type BLAP enzyme (cf. page 13, Table 2 of the patent).

If the deletion of the terms "at least" is not understood as limiting the scope of claim 1 to a specific mutant of the B. lentus DSM 5483 subtilisin protease (BLAP, SEQ ID NO. 22), then this deletion is completely irrelevant and claim 1 still has to be interpreted broadly (i.e. the claimed mutants are not limited to those having, only and exclusively, the amino acid alteration indicated in claim 1). This would have the effect, that the scope of claim 1, like the scope of claim 1 of the Main Request, remains ambiguous and unclear (cf. point 4 supra).

Thus, also the amendment present in claim 1 of Auxiliary Request 1 does not overcome the objections raised against former requests on file, introduces further ambiguity and raises new issues not considered so far in the proceedings.

6. Contrary to the Main Request, to Auxiliary Request 1 and to former requests on file, the "mutated subtilisin protease" comprised in the detergent composition of claim 1 in Auxiliary Request 2 is not defined as "a mutant Bacillus lentus DSM 5483 subtilisin protease" (cf. point XI supra). In line with the broad interpretation of the claim (cf. point 4 supra), claim 1 requires the mutated subtilisin protease to contain the specific amino acid alteration (L211D), but is not limited in any other way, neither with regard to the source of the subtilisin protease nor to the number and type of alterations additionally present in this mutant.

The introduction of the feature "for removal of egg stains from fabrics" has to be understood as limiting the claimed detergents to those having a composition suitable for this indented use.

Thus, in the light of the conclusions drawn by the board with regard to the Main Request and Auxiliary Request 1, also the amendments introduced into claim 1 of Auxiliary Request 2 do not overcome the objections raised against former requests on file.

7. Claim 1 of Auxiliary Request 3 is limited to a detergent composition for removal of egg stains from fabrics comprising at least one surfactant and the specific mutated subtilisin protease F49 encoded by SEQ ID NO. 16, for which an advantageous effect is shown in the patent. The limitation of the claimed subject-mater to a detergent composition comprising the mutant F49 and to a method for washing fabrics for removing egg stains using this detergent composition is clearly intended to overcome objections raised with regard to former requests on file and does not give rise to new issues not considered in earlier stages of the proceedings.

8. In view of the above considerations, following the provisions of Article 114(2) EPC, saying that the European Patent Office may disregard facts or evidence which are not submitted in due time, the board exercises the discretion conferred to it by Articles 12(4) and 13(1) of the RPBA and decides not to admit the Main Request and Auxiliary Requests 1 and 2 into the appeal proceedings and to admit Auxiliary Request 3 into these proceedings.

Referral of questions to the Enlarged Board of Appeal

9. In the light of the board's decision not to admit the Main request and Auxiliary Requests 1 and 2 into the proceedings, appellant I raised a point of law with regard to the legal basis and the legality of the RPBA and requested the referral of four questions to the Enlarged Board of Appeal (EBA) according to Article 112 EPC. These questions have been submitted at the oral proceedings in the German language (cf. point XIV supra).

10. It is evident from the file that this argument has been presented by appellant I for the first time at the oral proceedings. No reasons have been given why it has not been submitted earlier, so it is for the board to establish the chronological circumstances that led to this argument.

10.1 The statement setting out the Grounds of Appeal and the reply to appellant II's Grounds of Appeal were filed by appellant I on 7 July 2010 and 26 November 2010, respectively, under the name of the former patent proprietor Henkel AG & Co. KGaA. No submissions were filed by appellant I in reply to appellant II's letter of 4 February 2011 in which further experimental data were reported. In order to submit these experimental data, appellant II had previously requested the board for an extension of the time limit for replying to appellant I's statement of Grounds of Appeal. This request was granted by the board on 29 November 2010 with explicit reference to the RPBA, in particular to Article 12(5) RPBA (cf. points IV and V supra).

10.2 On 2 July 2013, the proprietor, Henkel AG & Co. KGaA, informed the EPO of the transfer and assignment of the patent-in-suit to the new proprietor BASF SE. A confirmation letter from the new proprietor was received at the EPO on 10 July 2013 and communications of amended entries concerning the transfer and the new representative were issued by the EPO on 15 July 2013. In a communication issued on 31 July 2013, the Registrar of the board informed the parties of all these amendments. No submissions were filed by the new proprietor at this point of the proceedings, neither with regard to appellant II's request for the extension of the time period, nor with regard to the board's decision to grant of this request or with regard to the admissibility of new experimental data, let alone with regard to the legality of the RPBA in general or with regard to specific Articles of the RPBA on which both this request and their grant were based.

10.3 On 7 November 2013, the board submitted summons for oral proceedings to the parties under Rule 115(1) EPC which, as an Annex, comprised a communication pursuant to Article 15(1) RPBA. In this communication, the board referred, inter alia, to Article 12(4) RPBA when informing of its intention not to admit some of the claim requests filed by the patent proprietor/appellant I and to admit the new experimental evidence filed by appellant II (cf. points 9 to 19 of the board's communication). The board also set a date for the parties to file observations and to make further submissions at one month before the scheduled oral proceedings (cf. point VI supra). Although in February 2014 both appellants announced their presence at these oral proceedings, none of them filed any substantive submission and no objections were raised in particular concerning the procedural rules governing the appeal procedure as such (cf. point VII supra).

10.4 In view of all these facts, the board is convinced that the new patent proprietor/appellant I had ample time and opportunities to address the point of law earlier in the procedure. Instead, it decided to present this fresh case only at the oral proceedings before the board, which would give the board the discretion to decide whether it is late filed and thus not admissible (Article 114(2) EPC and Articles 12(4) and 13(1) RPBA).

11. In the board's view, Articles 13(1) and 12(4) RPBA directly derive from inter alia Article 114(2) EPC and Rule 116(1) EPC, which enshrine the well-established procedural principle requiring the filing of the parties' facts, evidence and arguments at early stages of the proceedings. Furthermore, the board considers the RPBA to codify also the case law of the Boards of Appeal on established procedural practice (cf. inter alia, T 349/09 of 26 February 2010, point 9 of the Reasons and T 214/05 of 19 January 2007, point 1.3 of the Reasons). However, the board is aware that a decision on the referral of questions to the EBA concerning the legitimacy of the RPBA, which decision itself would rely also on the application of specific Articles of these RPBA, is not meaningful. Therefore, the board refrains from taking such decision.

12. As for appeal proceedings in general, Article 112(1)(a) EPC stipulates that the Board of Appeal, following a request from a party to the appeal, shall refer any question to the EBA if it considers that a decision is required in order to ensure uniform application of the law, or if an important point of law arises.

12.1 The questions drafted by appellant I do not relate to the aim of uniform application of the law. The RPBA are applied by all Boards of Appeal of the EPO and, in particular, the discretion given to the Boards of Appeal by Articles 12(4) and 13(1) RPBA is exercised by all Boards of Appeal for deciding on the admissibility or non-admissibility of facts, evidence or requests filed in appeal proceedings and/or on the amendment of a party's case in appeal proceedings.

12.2 The second alternative according to Article 112(1)(a) EPC concerns the possibility of questions to be referred to the EBA in case there exists an important point of law.

The questions formulated by appellant I rely on the assumption that the Administrative Council of the EPO has entitled the Presidium of the Boards of Appeal to legislate the RPBA, whereas the Administrative Council by itself can only accept the provisions as drafted by the Presidium.

This assumption of appellant I is neither well founded nor in line with the provisions laid down in Article 23(4) EPC which reads: "(t)he Rules of Procedure of the Boards of Appeal and the Enlarged Board of Appeal shall be adopted in accordance with the Implementing Regulations. They shall be subject to the approval of the Administrative Council", in combination with Rule 12(3) EPC which reads: "(t)he Presidium shall adopt the Rules of Procedure of the Boards of Appeal". Thus, it is clearly in the power of the Presidium to draft the RPBA and to adopt a version of these rules to be proposed to the approval of the Administrative Council. Eventually, this is not the result of any illegal delegation of the legislative competence of the Administrative Council, as wrongly submitted by appellant I.

It is the Administrative Council of the European Patent Organisation which decides, with respect of the requirements of Article 23(4) EPC and Article 35(1) EPC, to approve the RPBA which only thereby have the force of law and subsequently can be applied by the Boards of Appeal. Any further amendment of the RPBA shall also be approved under the same conditions by the Administrative Council. It is furthermore evident from the decision of the Administrative Council published in the Official Journal of the EPO, on pages 34 and 43 of the "Supplementary publication - Official Journal EPO 1/2014" under the heading "Information from the Boards of Appeal", that it is only and exclusively after the decision of the Administrative Council of the European Patent Organisation to approve the RPBA that they become part of the legal procedural system of the EPO. Thus, the legislative power is still unambiguously at the Administrative Council.

13. According to established case law of the Boards of Appeal questions based on unsubstantiated assumptions and hypothetical considerations are not suitable for a referral to the Enlarged Board of Appeal (cf. T 1213/05 of 27 September 2007, points 37 to 41 of the Reasons, and T 118/89 of 19 September 1990, point 5 of the Reasons). Therefore, appellant I's request for referral of questions to the Enlarged Board of Appeal is refused.

14. In the light of this decision, appellant I's considerations concerning the alleged incorrect and undemocratic composition of the Presidium of the Boards of Appeal do not have to be further investigated (cf. point XIV supra).

Auxiliary Request 3

Articles 123(2),(3) EPC

15. The subject-matter of Auxiliary Request 3 has been limited to embodiments related, only and exclusively, to the mutant F49 of sequence SEQ ID NO. 16. The scope of the claims of this request is thus narrower than the scope of the granted claims (Article 123(3) EPC) and there is ample basis for this subject-matter in the application as filed (Article 123(2) EPC). No objections have been raised by appellant II under these Articles and the board sees no reason to raise any of its own motion.

Article 84 EPC

16. In line with the case law of the Boards of Appeal, the purpose-related feature introduced into claim 1 of Auxiliary Request 3 requires the claimed detergent composition to be suitable for that purpose and excludes compositions not suitable for the removal of egg stains from fabrics (cf. point XII supra). No ambiguity arises from the introduction of this feature.

17. The K/C activity ratio of the subtilisin protease mutant F49 is disclosed in Example 14 of the patent as being 0.63. This ratio has been obtained using the method described in previous examples of the patent, in particular by using the liquid enzymatic detergent composition described in Example 13 (cf. pages 19 and 20 of the patent). Alterations in the specific composition and/or in the washing conditions used may result in a different K/C activity ratio. The board does not see a contradiction between claim 1, requiring the presence of a specific subtilisin protease mutant F49 in the claimed detergent composition, and the indication of a range for the K/C activity ratio in dependent claim 2 ("wherein said protease has a keratinase/caseinase activity ratio (K/C ratio) of less than 0.80, preferably less than 0.70.").

18. Therefore, Auxiliary Request 3 fulfils the requirements of Article 84 EPC.

Articles 83, 54 and 56 EPC

19. No objections have been raised by appellant II under Article 83 EPC nor does the board see a reason to raise any of its own motion either. The subtilisin protease mutant F49 of sequence SEQ ID NO. 16 is disclosed and fully characterized in the patent-in-suit, which also discloses detergent compositions for removal of egg-soot stains from fabrics comprising said mutant F49, and methods for washing fabrics based on this detergent. Thus, Auxiliary Request 3 fulfils the requirements of Article 83 EPC.

20. None of the prior art documents on file discloses a detergent composition for removal of egg stains from fabrics comprising the subtilisin protease mutant F49 encoded by SEQ ID NO. 16, i.e. the subject-matter of claim 1 of Auxiliary Request 3 (cf. point XII supra).

Document D2, the sole document cited by appellant II under Article 54 EPC in its Grounds of Appeal, discloses the replacement of the amino acid residue tryptophan (Trp) by, inter alia, the amino acid residue aspartic acid (Asp) at position 217 (Y217D) of the subtilisin protease BPN' from B. amyloliquefaciens (see Example 10 on page 98 of document D2). It is agreed by all parties that position 217 of the BPN' subtilisin protease corresponds to position 211 of the mutant F49, of the wild type BLAP and of the M131 mutant subtilisin proteases disclosed in the patent. As shown by the sequence alignment in document D11 and acknowledged in the patent (cf. inter alia, page 2, paragraph [0003] of the patent), the BPN' subtilisin protease has only 60% identity to the wild type BLAP subtilisin protease, and it is thus entirely different from the subtilisin protease mutant F49 disclosed in the patent.

Therefore, Auxiliary Request 3 fulfils the requirements of Article 54 EPC.

21. In line with the decision under appeal and appellant II's Grounds of Appeal (cf. page 21, point 29 and page 25, point 44 of the decision under appeal and page 8, point 7.1 of appellant II's Grounds of Appeal), document D4 is identified as representing the closest prior art.

Document D4 discloses mutants of the serine protease PB92 and of the subtilisin enzyme 309 derived from Bacillus novo sp. PB92 and the Bacillus strain NCIB 10147, respectively (cf. page 2, lines 8 to 15 of document D4). Document D4 further refers to homologues (with at least 70% homology) of these two enzymes.

The preferred group of mutant proteases comprises those which differ from PB92 and 309 by at least one mutation disclosed in the document and which include, among others, the mutation [L211E] (cf. inter alia, page 7, line 15 to page 8, line 5, page 8, lines 20 and 33, page 9, lines 6-7 and 33, page 11, lines 28-29 of document D4). Advantageous properties and washing performance of several mutants, including [L211E] PB92 mutants, are exemplified on page 21, Table II and pages 22 and 23, Table III of document D4. For the washing performance tests, document D4 refers to relevant stains known in standard washing tests, such as the exemplified cacao stains (cf. page 6, lines 11-13, page 14, Table of document D4).

Starting from this document, the objective technical problem to be solved by the present invention is the provision of a detergent composition comprising a subtilisin protease mutant with high efficiency for removal of a specific stain, namely egg stain. For the solution of this problem, the patent proposes the subject-matter of claim 1, a detergent composition comprising the subtilisin protease mutant F49. According to the examples, the technical problem is solved by the subject-matter of claim 1.

Although, as shown in the sequence alignment in document D5, the serine protease PB92 and the subtilisin enzyme 309 are structurally very similar to the BLAP enzyme from which the subtilisin protease mutants M131 and F49 are derived, there is no hint or suggestion in document D4 or in any other prior art document on file, that would have led a skilled person in a straightforward and obvious manner to a detergent composition comprising the mutant F49 with the specific sequence SEQ ID NO. 16, let alone to foresee its advantageous effect for removal of egg stains from fabrics.

No objections have been raised by appellant II under Article 56 EPC and the board, in view of the above considerations, does not see a reason to raise any of its own motion. Therefore, Auxiliary Request 3 fulfils the requirements of Article 56 EPC.