31 Mar 2016

T 1162/11 - Should or could have been filed earlier

Key points

  • About Article 12(4) RPBA:
    " Since in fact almost every claim request could have been presented before the department of first instance, the question within that context is whether the situation was such that the filing of this request should have taken place already at that stage." 
  • About the effect of lack of experiment results on inventive step in view of D6:
    " While neither in D6, nor in the patent in suit data are available that show an effective reduction in the risk of bearing premature or low birth weight infants (no studies in this respect were done), it is the results presented in D68 (and equally cited in D6 and in the patent) that make it credible in both cases that by treating the periodontal disease a reduction in the risk of bearing premature or low birth weight infants takes place. (...) Under such circumstances and considering the equal credibility of the teaching in D6 and in the patent in suit [], the technical problem is the provision of an alternative treatment."

EPO T 1162/11 - link 


The Main Request reads as follows:
"1. Use of an antimicrobial selected from stannous ion agents; triclosan; [...] bacteriocins; analogs and salts thereof; and mixtures thereof, in the manufacture of a topical oral composition
for reducing the risk of bearing premature and low birth weight infants in humans and other animals,
wherein the composition is in a form selected from a mouthrinse, toothpaste, tooth gel, tooth powder, non-abrasive gel, chewing gum, mouth spray, lozenge, and a pet chew product and comprises a pharmaceutically acceptable oral carrier."
Reasons for the Decision
Admissibility of the appeal
1. Rule 99(1)(c) EPC prescribes that the notice of appeal shall contain a request defining the subject of the appeal. According to the case law this is satisfied if the notice of appeal contains a request to set aside the decision in whole or, (where appropriate) only as to part and it is not necessary in the case of an appeal by a proprietor for the notice of appeal to contain a request for maintenance of the patent in any particular form, which is something which relates to the extent to which the decision is to be amended, and which is therefore a matter for the statement of grounds of appeal under Rule 99(2) EPC (Case Law of the Boards of Appeal of the EPO, 7th edition 2013, IV.E.2.5.2 c), in particular decision T 358/08 of 9 July 2009).
1.1 In the present case the notice of appeal included the explicit request that the decision under appeal be set aside (see point VI, above), which results therefore in the requirements of Rule 99(1)(c) EPC being met.
This fact cannot be changed by a possible decision on the admittance of the requests filed with the statement of grounds which is under the discretion of the Board (Article 12(4) RPBA). Such a decision will influence which requests must be decided upon on the substance, but can have no impact on the admissibility of the appeal, which is not a discretionary decision.
1.3 Accordingly, the requirements of Rule 99(1)(c) EPC are fulfilled. The Board has no doubt that all other formal requirements are met (which has not been contested by the respondents).
1.4 In view of that, the appeal is admissible.
Admittance of the claim requests
2. The main request, as well as the second, third and fifth auxiliary requests, were originally submitted with the statement setting out the grounds of appeal, and were subsequently renumbered with letter of 18 September 2015 after addition of two further requests (first and fourth auxiliary). Thus according to Article 12(1) RPBA, the main request and the second, third and fifth auxiliary requests form part of the basis for appeal proceedings.
2.1 However, the respondents considered that they should not be admitted under Article 12(4) RPBA, which gives the Board the discretion to hold inadmissible requests which could have been presented or were not admitted in the first instance proceedings.
2.2 Since in fact almost every claim request could have been presented before the department of first instance, the question within that context is whether the situation was such that the filing of this request should have taken place already at that stage.
Claim 1 of the main request corresponds to claim 1 of the third auxiliary request decided upon by the opposition division with the limitation of the medical indication to one of the two alternatives (only reducing the risk of bearing premature and low birth weight infants by deleting the reduction of the risk of atherosclerosis) and the deletion of the specification "by treating chronic periodontal infection" (see points IV and IX, above).
2.4 The opposition division found that the third auxiliary request did not involve an inventive step taking position on both alternatives (see point V e), above). The analysis of inventive step of the main request on file is therefore clearly an issue decided upon by the first instance. This is confirmed by the attacks of the respondent which follow the same lines as those before the opposition division and is not changed by the further amendment, which might be discussed under Article 123(2) EPC, but has no impact on inventive step.
2.5 The main request does not result therefore in a fresh case, which has not been examined by the opposition division. Moreover, the limitation to one of the two alternatives appears to be a genuine attempt of the appellant to overcome the objection by restricting the subject-matter to what in its view may be better supported by the evidence on file.
2.6 Consequently the Board considers it appropriate to admit the main request into the proceedings.
[...]

6.9 While neither in D6, nor in the patent in suit data are available that show an effective reduction in the risk of bearing premature or low birth weight infants (no studies in this respect were done), it is the results presented in D68 (and equally cited in D6 and in the patent) that make it credible in both cases that by treating the periodontal disease a reduction in the risk of bearing premature or low birth weight infants takes place. Indeed in D68 a case-control study of 124 pregnant or postpartum mothers was performed and a clear correlation was found between periodontal disease and preterm low birth weight (see abstract and discussion on pages 1110-1112), which makes it credible that by treating periodontal disease (as in D6 or in the patent in suit) a reduction of the risk of bearing premature or low birth weight infants is achieved.
6.10 In other words, the teaching of D6 is as credible (or as speculative) as the teaching in the patent in suit, all the more as no limitation on the quantity of therapeutic agent is given in claim 1 and as toothpicks were even mentioned as alternative to the now claimed forms of composition in the original application from which the patent stems (page 20, last paragraph).
With regard to the identified difference (one of the listed forms instead of a toothpick), no comparative data are available to show that an improvement or an advantage is present for the subject-matter of claim 1 of the main request over the disclosure in D6. Even the post-published study in D63, which has been cited by the appellant as evidence for the formulation of the technical problem, concerns the treatment with an antimicrobial mouth rinse containing cetylpyridinium chloride and its incidence on preterm birth (see objective), but does not provide any comparison with D6.
6.12 Under such circumstances and considering the equal credibility of the teaching in D6 and in the patent in suit (see points 6.9-6.10, above), the technical problem is the provision of an alternative treatment for reducing the risk of bearing premature and low birth weight infants in humans and other animals.
6.13 In view of the teaching in D68 which establishes the link between untreated periodontal disease and an enhancement of the risk of bearing premature or low birth weight infants (see points 6.8-6.9, above), the skilled person, starting from D6, would consider all known ways of treating periodontal diseases as obvious solutions to the posed problem.
6.14 The treatment of periodontal disease by means of topical oral compositions as the ones listed in claim 1 of the main request was undoubtedly known in the art (see e.g. abstracts of D1, D21, D22), which has not been contested by the appellant. The fact that other treatments, such as a mechanical treatment, were also known and possible does not render the treatment by the listed topical oral compositions inventive. On the contrary, it would render obvious also a further alternative treatment.
6.15 On that basis it is concluded that the subject-matter of claim 1 of the main request does not involve an inventive step.

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