Key points
- The method of claim 1 specifies (after claim construction) as step a) diluting a fermentation broth that comprises subtilisin crystals and/or subtilisin precipitate. The opponent submits that the patent provides no enabling disclosure of providing such a fermentation broth.
- The Board: “the provision of a fermentation broth comprising subtilisin crystals and/or subtilisin precipitate is a feature of the claim that has to be taken into consideration when assessing whether or not the claimed invention is sufficiently disclosed. The board considers it irrelevant in this context that the claim does not explicitly require the provision of such a fermentation broth, since such requirement is a necessary consequence of the express language of the claim and thus implied.”
- Accordingly, the patentee's argument “that it was enough for sufficiency of disclosure that the skilled person could determine whether or not crystals were present in the fermentation broth and that the claimed invention started at the point where the skilled person was faced with the recovery of subtilisin from a fermentation broth in which it was present in crystalline or precipitated form must fail.”
- “ The board concludes from the above that it is a verifiable fact that neither the patent nor the state of the art cited therein provide any guidance for the skilled person with respect to the technical measures to be applied in the fermentation process of subtilisin proteases to achieve such high yields that subtilisin crystallises spontaneously in the fermentation broth during fermentation.”
- “The board concurs with the appellant that it can be inferred from paragraph [0002] of the patent that the claimed method is to be applied in particular in circumstances in which the presence of subtilisin crystals in the fermentation broth is the result of a "dramatic" increase in the fermentation yield.”
- “Notably, the [patentee] had themselves submitted that the "dramatic" increases referred to in paragraph [0002] of the patent "had arisen as a result of years of optimisation and improvement in the production process and production microorganism". However, evidence that the skilled person was aware of the concrete measures of optimisation and improvement to be taken to reliably reach such high yields in fermentation resulting in subtilisin crystals had not been provided by the respondent.”
- As a comment, we are talking about fermentation, so quite likely the patentee, as well as the opponent, has a few closely guarded trade secrets. Quite possibly every industrial company in the field of fermentation production of the compound at issue is able to achieve highly concentrated fermentation broths, but the various secret tricks (and microorganisms) used by them are nowhere to be found in the prior art.
T 0518/17 -
https://www.epo.org/law-practice/case-law-appeals/recent/t170518eu1.html
Main request (patent as granted) - claim 1
Claimed invention - claim construction
11. The claim is directed to a method of solubilising subtilisin crystals and/or subtilisin precipitate in a fermentation broth. The method comprises three explicit steps, denoted a), b) and c). In step a), the fermentation broth is diluted 100-2000% (w/w).
12. The fermentation broth is not characterised further in the claim. However, the parties concurred that, as a consequence of the purpose indicated in the claim ("solubilizing protease crystals and/or protease precipitate ... wherein the protease is a subtilisin") the skilled person will understand that the fermentation broth referred to in method step a) has to comprise subtilisin crystals and/or subtilisin precipitate. The board concurs with this claim construction. Accordingly, the claimed method comprises as step a) diluting a fermentation broth that comprises subtilisin crystals and/or subtilisin precipitate.
Sufficiency of disclosure (Article 100(b) EPC)
13. In the decision under appeal, the opposition division had held that "the formation of crystals and/or precipitates cannot be considered as a technical step of the method claimed, and thus the points raised by the O's [appellant] in respect of the alleged inability to obtain at least such crystals are of no relevance to sufficiency of disclosure, since these steps do not have to be carried out as part of the claimed invention."
source http://justpatentlaw.blogspot.com/2021/09/t-051817-solubilising-subtilisin.html
