EP 2 513 134 B1 relates to a wash solution and a method for affinity chromatography.
Brief outline of the case
The OD maintained the patent according to a new MR.
Claim 1 of the MR relates to a method of producing certain purified proteins of interest, using an affinity chromatography (AC) matrix to which one of the proteins of interest is bound, the method comprising washing the AC matrix with a specific wash solution.
In the impugned decision, the OD concluded that claim 1 of the MR complied with the requirements of Art 123(2).
Out of the four opponents, opponents 1 and 2 appealed this decision.
The board held that the MR offended Art 123(2).
During OP, the proprietor only upheld AR26, which was also considered infringing Art 123(2).
The patent was thus revoked.
The opponent’s point of view
Claim 1 of the MR comprises at least the following multiple selections deriving from the disclosure of the application as filed:
- the protein to be purified being an antibody, antibody fragment, or Fc fusion protein,
- the concentration of arginine or arginine derivative in the wash solution,
- the concentration of the non-buffering salt in the wash solution, and
- the pH of the wash solution being greater than 8.0.
The board’s decision
Firstly, regarding the selection of the protein to be purified being an antibody, antibody fragment, or Fc fusion protein, it is necessary to combine two selections of the antibody, antibody fragment, or Fc fusion protein, from two lists. There is, however, nothing in the original disclosure that points to any preference for making the combination of these selections.
Secondly, with regard to the concentration of arginine or arginine derivative in the wash solution, the concentration range of “between 0.05 and 0.85 M” was selected in favour of the general and broadest range of “between 0.05 and 2.0 M and the most preferred range of “between 0.1 and 0.5 M”
It follows that the concentration of arginine or arginine derivative in the wash solution of claim 1 of the main request (0.05 to 0.85 M) represents the preferred range, but not the most preferred range. This is not changed by the fact that the chosen range of between 0.05 and 0.85 M is followed by the wording “which is the upper solubility of arginine in water at 20 C”.
The fact remains that, after this wording, an even narrower range of between 0.1 and 0.5 M is disclosed as the most preferred range, which – unmistakably – puts the chosen range at only an intermediate level of preference.
As regards the concentration of the non-buffering salt in the wash solution, the range of “between 0.1 and 2.0 M” was selected, while concentrations in a range “between 0.5 M and 1.5 M” and “between 1 M and 2 M”, whereby both these ranges being narrower than – and lying completely within – the selected range. The selected range thus represents the selection of the broadest range out of the list of ranges originally disclosed.
This conclusion is not changed by the fact that this broadest range is preceded by the adverb “typically“. Firstly, the sentence containing “typically” encompasses the three ranges “between 0.1 M and 2.0 M”, “between 0.5 M and 1.5 M”, and “between 1 M and 2 M”.
It follows that the term “typically“ applies to each of the three ranges. In any case, the board does not see why the term “typically”, even if referring only to the chosen range of between 0.1 M and 2.0 M, should confer a preference for the chosen range. The fact remains that the ranges that are subsequently cited in this original sentence are narrower than the chosen range. Hence, these two narrower ranges are preferred over the chosen broadest range of “between 0.1 M and 2.0 M”.
With regard to the pH of the wash solution, the pH of greater than 8.0 is the broadest range for the pH originally, and it does not constitute a preferred embodiment.
While the original passages refer to a pH of the wash solution of greater than 8.0, they should be considered in the context of the whole original disclosure. The pH of greater than 8.0 thus does not represent the preferred range disclosed in the combination of original claims 11 to 13.
Furthermore, looking at the examples of the application as filed, nothing can be seen that points to all selections made in claim 1 of the MR.
The original examples do not point to the combination of features resulting from the selections of at least the concentration of arginine or arginine derivative and the concentration of the non-buffering salt in the wash solution.
The board concluded that the combination of the features relating to the specification of the protein to be purified, the concentration of arginine or arginine derivative in the wash solution, the concentration of the non-buffering salt in the wash solution and the pH of the wash solution is based on multiple selections at different levels of preference without any pointer being present in the application as filed for these selections.
The skilled person reading the application as filed would thus find no guidance as to which of the preferred features they should start with and which of the other features are then to be combined.
Comments
The present decision reminds us that multiple selections made at different levels of preference end up in added matter, and that the examples of the application as filed cannot serve as a pointer.
The board reminded that the content of the application as filed must not be considered to be a reservoir from which features pertaining to separate embodiments are taken and combined to artificially create a particular embodiment without the presence of a pointer to combine the features of the separate embodiments. See for instance T 1334/09, Reasons 3.3.1, T 296/96, Reasons 3.1 or T 776/16, Reasons 3 or T 1251/19, Reasons 2.4.
The most used criterion when assessing added matter is what is “directly and unambiguously derivable” from the original application/patent, see G 2/10, and numerous decisions relying on G 2/10.
Case law has also developed two further criteria for assessing added matter
- the original application/patent is not a reservoir of features combinable at will, see above
- the allowability of an amendment should be beyond any reasonable doubt, see T 1006/03, Reasons 2.2, T 465/07, Reasons 3.10.1, T 299/99, Reasons 2.7.4. All those decisions refer to T 383/88, Reasons 2.2.2.1.
Some decisions even combine the concept of the reservoir and require in case of combination of features a pointer towards a given combination in order to decide whether a feature is derivable directly and unambiguously from the original specification.
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