T 1456/23 - A non-obvious alternative (soft gelatin capsule)

Key points

• "In appeal, the appellant [opponent]  takes the hard gelatin capsule of formulation 9, example 1 of D11 as sole starting point for the assessment of inventive step."
• " The subject-matter of claim 1 differs from formulation 9 of D11 in that the claimed capsule is a soft gelatin capsule with a soft capsule shell as defined in claim 1."
• "The [proprietor] relies, among others, on D5 (Annex III and Annex IV) and D83 (Annex V) as evidence of a technical effect on bioavailability associated with the differentiating feature." "The [opponent] contests that these post-published data can be taken into account in view of G 2/21,"
• "The application as filed mentions the problem of providing immediate release calcifediol solid oral formulations having improved bioavailability. As a solution to this problem, the application as filed proposes, in its broadest disclosure, a soft capsule comprising a further undefined soft capsule shell. The particular soft capsule shell composition of present claim 1 is however disclosed on page 9, lines 24-27 and is embodied by the single soft capsule shell prepared in the examples"
• The Board: " It is not debated that the evidence in the application as filed, comparing soft capsules with ampoules, is not suitable to show an effect over the hard capsules of D11. However, the Board considers that the skilled person, based on the application as originally filed, would derive the effect of improved bioavailability associated with the soft capsule including a soft capsule shell composition of present claim 1 as being encompassed by the technical teaching and embodied by the same originally disclosed invention. Considering the preference for and presence of the specific soft capsule shell of claim 1 in the examples studying bioavailability, the link between bioavailability and not only a soft shell generally but also, as the case may be, the now claimed specific soft shell composition, does not change the nature of the claimed invention."
• As a comment: the remark about "the link between bioavailability and not only a soft shell generally but also, [...]  the now claimed specific soft shell composition,' appears to refer to the "no cross-reliance" part of G 2/21 hn. 2: "would derive said effect as being ... embodied by the same originally disclosed invention." 
• "  the Board concludes that the problem is the provision of soft capsules with improved bioavailability of calcifediol"
• Perhaps the reference to 'soft capsules' is a slip of the pen, because the prior art Formulation 9 is about hard capsules, so 'soft capsules' is part of the claimed solution.
• For the obviousness, it is important that claim 1 is directed to an "An immediate release soft capsule" containing calcifediol. Immediate relese formulations and 'modified release formulations' are two different types of formulations. 
• "The gist of D11 is to provide modified release formulations containing wax, and D11 further mentions as one benefit an improved bioavailability []. While some immediate release formulations are shown in D11, this is for comparative purposes only. 
• The choice of D11 as starting point for the assessment of inventive step defines the framework for further developments. The skilled person, seeking to improve the bioavailability of the formulation, would not do away with the key feature of D11 pertaining to a modified release formulation. 
• In this respect, the results reported in D11 do not point to the claimed formulation. ... the [comparative ]  immediate release formulation 9 of example 1 leads to a lower calcifediol bioavailability than the wax-comprising, modified release formulations 3 and 4 of Example 1 (see table 5 of D11). The skilled person, seeking to provide calcifediol formulations with improved bioavailability, is thus not led to the claimed solution.
  
• As a comment, perhaps the above reasoning would also apply in the case of providing an alternative as the objective technical problem. 

• On the type of evidence ofr the improved bioavailability: "the Board considers that a party filing experimental data is not under the obligation to perform any specific statistical analysis of these data, and that, in establishing whether a certain technical effect alleged by a party has been achieved, the EPO has to apply the general principle of free evaluation of evidence (see T 2717/17, point 4.3.5 of the reasons). The decisions cited by the appellant in this regard were either taken in the particular context of qualitative results in tests with a subjective character (see T 1962/12, point 1.5.1 and 1.5.2 of the reasons; T 275/11, point 3.5.2 of the reasons) or in situations where the data were considered not reliable for various reasons which do not characterise the present case, i.e. not simply on account of the small number of tested individuals (see T 785/07, point 2 of the reasons). In the case at hand, the above data are sufficiently convincing considering the information given on the methodology and the absence of demonstration to the contrary. In addition, these in vivo data in dogs are in line with the in vitro data on file (see 3.3.2(b) above). Under these circumstances, the Board considers that, even taking into account the small group of dogs tested (i.e. 3 dogs) and the alleged high inter-individual variability, the effect of improved bioavailability is shown to a sufficient degree of credibility."

EPO 

The link to the decision can be found after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t231456eu1