G 2/10 and Selections from Lists: T 0201/24 on Added Matter in Divisional Applications
In T 0201/24, the EPO Technical Board of Appeal clarified that applying the gold standard of G 2/10 does not preclude assessing added matter through selections from lists. The decision highlights the strict requirements for combining component ranges.
The doctrinal relationship between the gold standard for added matter articulated in G 2/10 and the traditional approach of assessing selections from multiple lists has frequently shaped opposition proceedings. In T 0201/24, the Technical Board of Appeal addressed this exact tension, clarifying that applying the gold standard does not preclude an analysis based on selections from lists when evaluating amendments to a divisional application under Article 76(1) EPC.
Why did the appellant argue against the list-based assessment?
The patent proprietor argued that the opposition division had incorrectly focused on whether the claimed features were taken from lists, rather than applying the gold standard. According to the appellant, a proper technical assessment of the overall circumstances would show that the skilled person was not presented with new technical information. Specifically, the appellant contended that the earlier application as filed taught no interrelation between the encoded betacoronavirus antigen and the specific composition of the lipid nanoparticle. The appellant argued that what was relevant for the composition was its use for delivering a polyanionic molecule, not the sequence of amino acids encoded. Consequently, combining the spike protein with the specific lipid ranges in claim 1 allegedly did not constitute an arbitrary selection.
How did the Board reconcile G 2/10 with the selection from lists?
The Board rejected the premise that the list-based approach contradicts the gold standard. Citing T 1462/24, the Board noted that assessing whether claimed subject-matter amounts to combinations from selections made from several lists remains a valid analytical tool (reasons 6). This approach is simply a means of evaluating the amendments against the earlier application as filed, serving the ultimate purpose of applying the gold standard. Consequently, the Board proceeded to examine whether the specific combination of the antigen and the four lipid component ranges was directly and unambiguously derivable from the earlier application as filed.
Why did the specific lipid nanoparticle composition lack a valid pointer?
Claim 1 defined the lipid nanoparticle by four specific component ranges: 40–60% cationic lipid, 5–15% non-cationic lipid, 1–2% PEG lipid, and 30–50% cholesterol. While the earlier application as filed placed great emphasis on formulating mRNA in lipid nanoparticles, it disclosed a wide variety of compositions. These included particles with a single lipid, three components, or four components present in multiple different percentage ranges. The Board found that it was not apparent which combination of component classes or ranges was preferred (reasons 8).
Furthermore, although Example 20 disclosed a specific formulation falling within the broad definition of claim 1, this experiment had not been carried out. The Board observed that Example 20 did not contain any technical information other than the concept of delivering mRNA encoding the S protein or its S1 and S2 subunits formulated in a lipid nanoparticle (reasons 9.4). It provided no guidance on why its specific composition was suitable, nor did it offer criteria for extrapolating those specific percentages to the broader ranges claimed.
What must practitioners change when combining ranges and targets after this decision?
For European patent attorneys prosecuting or defending divisional applications, this decision reinforces the strict requirements for combining specific component ranges with specific active agents. When an application discloses multiple overlapping ranges and various component classes, pointing to a single example that falls within a newly claimed broader range is insufficient to establish a direct and unambiguous disclosure. Practitioners cannot rely on a general assertion that two features lack a functional interrelation to justify combining them. Instead, the application as filed must contain a clear pointer to the specific combination of ranges and components. If the original text lacks guidance on how to extrapolate from a specific example to a broader claimed range, that combination is unlikely to satisfy the gold standard under Article 76(1) EPC.