T 0688/14 - The normal tasks of the skilled person and expectation of success

Key points

• In this opposition appeal, the Board concludes that the claim at issue is obvious. 
• The Board: “although the case law defines the skilled person as being cautious and having a conservative attitude [...], it also acknowledges that furthering the existing state of art belongs to the normal tasks of the skilled person and that routine adaptations or trials as well as the use of known alternatives do not go beyond what may be normally expected from an average person skilled in the art”
• “The question whether a skilled person would do something may be answered by assessing first whether there was any motivation or incentive for the skilled person to do it and, if this question is answered in the positive, to assess then the expectations of the skilled person for doing it.” (emphasis added). 
• This approach makes sense to me.
• As regards the expectations of the person skilled in the art, the board considers that they are always directly associated with the intended purpose and thus, intrinsically linked to the formulated technical problem.
  When the intended purpose or the technical problem are formulated in very ambitious terms, such as the achievement of a significant improvement or a surprisingly advantageous effect over the prior art, the expectations of the skilled person to succeed are correspondingly more difficult to be fulfilled.
  The expectations to succeed are certainly much greater, when the intended purpose or the technical problem are formulated in less ambitious terms, such as in the present case, namely the provision of a simple alternative to the method known from the prior art.
• About try-and-see: “the case law acknowledges that, in certain cases, a skilled person may adopt a "try and see" attitude and, in these cases, there is not need to have any sort of expectation” .

EPO T 0688/14 - link

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25. The question whether a skilled person would do something may be answered by assessing first whether there was any motivation or incentive for the skilled person to do it and, if this question is answered in the positive, to assess then the expectations of the skilled person for doing it.

25.1 As regards the first question, although the case law defines the skilled person as being cautious and having a conservative attitude (cf. "Case Law", supra, I.D.8.1.3, 191), it also acknowledges that furthering the existing state of art belongs to the normal tasks of the skilled person and that routine adaptations or trials as well as the use of known alternatives do not go beyond what may be normally expected from an average person skilled in the art (cf. inter alia, T 455/91, OJ EPO 1995, 684, point 5.1.3.3 of the Reasons; T 659/00 of 1 July 2003, points 8 and 9 of the Reasons; T 769/03 of 23 September 2004, point 6 of the Reasons; T 1439/04 of 22 June 2006, point 3 of the Reasons).

In the present case, the skilled person was well aware of the commercial relevance of human factor VIII as reflected by the widespread interest for its industrial production (cf. document (3)). Thus, there is no doubt that a skilled person would be highly motivated to seek appropriate modifications, changes and alternatives to the methods for production described in the art.

In the present case, the proposed solution is part of the common general knowledge of the skilled person; it does not require the skilled person to turn to a particular prior art document, the combination of teachings from different technical fields, etc. Moreover, it neither takes incalculable risks nor goes against any prejudice, on the contrary, it relies on a basic technique that was widespread in the relevant technical field and, as put forward by  [opponent], was known to every undergraduate student.

25.2 As regards the expectations of the person skilled in the art, the board considers that they are always directly associated with the intended purpose and thus, intrinsically linked to the formulated technical problem. When the intended purpose or the technical problem are formulated in very ambitious terms, such as the achievement of a significant improvement or a surprisingly advantageous effect over the prior art, the expectations of the skilled person to succeed are correspondingly more difficult to be fulfilled. The expectations to succeed are certainly much greater, when the intended purpose or the technical problem are formulated in less ambitious terms, such as in the present case, namely the provision of a simple alternative to the method known from the prior art.

25.3 It is also worth noting the case law dealing with the assessment of an expectation of success for what in this case law has been called a "try and see" situation. According thereto, there is a difference between the expectation to succeed and the certainty to success, the latter not being required for deciding on a lack of inventive step (cf. "Case Law", supra, I.D.7.1, 185). Indeed, the case law acknowledges that, in certain cases, a skilled person may adopt a "try and see" attitude and, in these cases, there is not need to have any sort of expectation (cf. "Case Law", supra, I.D.7.2, 187). Whilst  [opponent] argues that this situation applies to the present case,  [patentee] argues that, in the present case, the skilled person would have adopted a sceptical attitude and not a "try-and-see" attitude.

25.4 The board agrees with   [patentee] that document (8) discloses that vWF not only overcomes the tendency of the recombinant factor VIII to associate with the CHO membrane but also to stabilize and protect it from proteolysis by acting, in the words of [patentee],  as a blanket or chaperone (cf. page S10, left-hand column, last full paragraph of document (8)). However, contrary to [patentee], the board does not consider that, in view of the effects of vWF, there were reasons for a skilled person to adopt a sceptical attitude when looking for a method for the production of recombinant human factor VIII without co-expression of vWF.

In the board's view, document (8) not only informs the skilled person of the presence of several problems when trying such a method but it also provides means and measures to overcome them, such as the selection of available host cell lines with low proteolytic activity. Indeed, these problems were already known in the art and means and measures to solve them were also provided therein, such as the use of protease inhibitors in document (22). None of these means and measures is excluded from the scope of claim 1 of the auxiliary requests. There was no reason for a person skilled in the art to ignore all the information at hand and to select the worst possible known system or method when facing a "try-and-see" situation. It is worth noting here that, in the present case, the skilled person was not looking for an improvement or a surprisingly advantageous effect, but only for an alternative method.

26. It follows from the above that the person skilled in the art could and, in the board's view, would have modified the system described in document (8) by applying conditions of high ionic strength, i.e. increasing the concentration of at least one of the ionic substances listed in claim 1.

27. As a further argument to support inventive step, [patentee] referred to document (18) as providing an alternative for replacing the vWF in the method disclosed in document (8) which was much closer to the co-expression system disclosed in document (8), namely a co-expression of human factor VIII with the antibody BO2C11 whose binding site for factor VIII includes or overlaps the factor VIII binding site for vWF. The board does not agree and considers that, as stated in the case law, "the mere fact that it is possible to imagine other, more or less obvious solutions does not necessarily imply that an invention involves an inventive step, or can be regarded as an inventive selection" (cf. T 214/01 of 7 March 2003, point 3.11 of the Reasons; T 190/03 of 29 March 2006, point 14 of the Reasons). In the present case, the alleged presence of another possible obvious solution is not relevant and does not change the findings of obviousness for the proposed solution, i.e. the method of claim 1.

28. [Patentee] has also referred to what has been called in the case law "secondary indicia" for supporting an inventive step (cf. "Case Law", supra, I.D.10, 243). The board is however not able to follow this argumentation.

28.1 Although the case law acknowledges that, in certain situations, a simple solution may be indicative of inventive step (cf. "Case Law", supra, I.D.10.7, 249), this is not always the case. In the decisions dealing with this situation, the simple solution did not lower the yield of the method and/or the quality of a product known in the art; the product being of commercial interest and produced in industrial settings. Moreover, in most cases, the simple solution brought about a surprising (functional) improvement and/or resulted in an improved effect. However, even though the commercial interest of human factor VIII was well-known (inter alia, document (3)) and reference is made in the patent to 10 L bioreactors (cf. paragraphs [0076] and [0150]; see also page 24, Example 11 of the patent), the claimed method is neither limited to the large-scale production in an industrial setting nor does it require to achieve any surprising effect or improvement at all.

28.2 [Patentee] has also referred to what has been called in the case law the "time factor", namely the time lapsed between the publication of the closest prior art (document (8), 1994) and the filing date of the patent (2006), as an additional indication of inventive step. Again, even though the case law acknowledges that the time factor may in certain cases be indicative of inventive step (cf. "Case Law", supra, I.D.10.3, 246), this is not always the case. The failure to adopt an obvious solution has been associated with a variety of possible causes, in particular, those related to commercial reasons such as the avoidance of investment costs involved in the adoption of a new technique on an industrial scale (cf. T 123/97 of 10 September 1998, point 2.4.5 of the Reasons; T 516/08 of 16 December 2009, point 10 of the Reasons). Moreover, in the present case, the time lapsed between the publication date of the industrial production of recombinant human factor VIII in serum-free conditions (mid- or in the late nineties; cf. documents (3) and (8)) and the priority date of the patent (early 2005) does not compare with the time lapsed in most of the cases underlying the relevant decisions referred to in the case law (over 20, 60, up to 100 years).

29. In view of all these considerations, the board arrives at the conclusion that the auxiliary request does not fulfil the requirements of Article 56 EPC.

Conclusion

30. In the absence of a request that fulfils the requirements of the EPC, the patent must be revoked.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.