The patent relates to an age-tailored nutritional composition system.
The system contains two or more nutritional compositions comprising different amounts of human milk oligosaccharides (HMOs).
The idea underlying the invention is to provide the infant with different nutritional compositions which reflect its evolving nutritional needs over time, in particular at different ages.
The patent describes a clinical study showing how the concentration of HMOs in human breast milk varies over time during lactation.
Brief outline of the procedure
For the OD, the new MR filed during opposition and AR 1 contravened Art 123(2), but that AR 2 did not.
The patent was thus maintained by the OD according to AR2.
Opponent 2 appealed the decision.
The board decided that claim 1 as maintained was infringing Art 123(2). The same applied to AR 1-3 in appeal.
The patent was thus revoked by the board.
The case is interesting as it deals with selections from lists.
The proprietor’s argumentation
Amended claim 1 of the MR=as maintained, was based on claims 1, 10, 13 and 14 and Figures 1A and 2 as filed.
For the proprietor once 2′-FL was selected from claim 10, it had to be included in both compositions A and B. The use of different HMOs in these compositions was against the teaching of the application as filed.
The criteria outlined in T 1621/16 for making multiple selections from lists of converging alternatives without violating Art 123(2) were met.
There was a pointer to the claimed combination of features. The application as filed identified the 2′-FL concentrations shown in Figure 1A as preferred. Those of Figure 1B were less preferred.
The 2′-FL concentration ranges in claim 1 were purposefully selected, these being the broadest which included the concentrations of 2′-FL of Figure 1A and 2 but excluded those in Figure 1B.
Claim 1 of AR 1 required all recited HMOs to be present, this being a preferred embodiment of the application as filed. The claimed scope was limited without singling out embodiments. The amounts of HMOs in claim 1 were purposefully selected. They were the broadest which included the preferred HMO concentrations in Figures 1A and 2 and excluded the less preferred ones in Figure 1B.
As in T 350/18, the requirements of Article 123(2) EPC were complied with.
The proprietor submitted that although multiple selections had to be made to arrive at the claimed subject-matter, the teaching of the application as filed taught toward the claimed combination of features.
The board’s position
Claim 1 of the MR differs from claim 1 as filed in at least that:
– the amount of HMOs in composition A exceeds that in composition B
– 2′-Fucosyllactose (2′-FL) is present in both compositions A and B furthermore, in that 2′-FL is present in an amount of:
– 1000 to 2000 mg/L in composition A
– 1000 to 1500 mg/L in composition B
For the board, it is established case law that the content of an application must not be used as a reservoir from which features pertaining to separate embodiments can be combined to artificially create an embodiment.
In the absence of any pointer to the combination, the combined selection of features does not, for the person skilled in the art, emerge clearly and unambiguously from the content of the application as filed (see “Case Law of the Boards of Appeal of the EPO”, II-E.1.6.1 and the decisions cited there).
Decision T 1621/16 does not provide for an exception to this rule. It requires, in fact, that a claim amended on the basis of multiple selections from lists of converging alternatives may only be considered to meet the requirements of Art 123(2) if the application as filed includes a pointer to the combination of features resulting from the multiple selections (see the catchword, point 2).
The board held that, the mere fact that features are described in the application as filed in terms of lists of more or less converging alternatives does not give the proprietor a “carte blanche” for freely combining features selected from a first list with features selected from a second list disclosed in the application as filed.
Any such amendment will only be allowable under Art 123(2) if it complies with the “gold standard” defined in decision G 2/10 (reasons 2.15 of the present decision).
In the current case, the application for the opposed patent was drafted to provide a large reservoir of options and alternatives to be selected and combined to create a vast number of embodiments.
The application as filed describes a clinical study monitoring the concentration of HMOs in human milk during lactation. The results show that the concentrations of HMOs decrease over time.
However, the application was drafted to go far beyond this finding and to encompass age-tailored nutritional systems which can satisfy any foreseeable evolving nutritional need for HMOs, not only their decrease over time.
Claim 1 as filed encompasses any system comprising two compositions A and B, where A is for infants of 0 up to 1 month and B is for infants of 1 to 2 months of age and where the two compositions comprise different amounts of HMOs.
It does not require composition A to contain an excess of HMOs compared to composition B. It does not require compositions A and B to comprise the same HMO/HMOs either.
The proprietor’s argument that when 2′-FL is selected from the various HMOs listed in claim 10 as filed, this compound must necessarily be present in both compositions A and B, otherwise the claims would not make technical sense, does not convince. Accordingly, two selections have already to be made for 2′-FL to be present in both compositions A and B.
Furthermore, the “and/or” structure in passages on pages 35 and 36 and in claim 13 implies that to arrive at the subject-matter of claim 1, additional selections have to be made.
The proprietor submitted that these selections did not create new subject-matter because Figures 1A and 2 as filed pointed to the claimed combination of features. The skilled person would have recognised that the claimed combination of ranges was the most preferred of the application because the selected ranges were the broadest which included the preferred 2′-FL concentrations shown in Figures 1A and 2 which also excluded the less preferred concentrations shown in Figure 1B.
The application as filed describes two examples of systems including age-tailored sets of nutritional compositions comprising variable levels of HMOs (example 1 on pages 54 to 57 and example 2 on pages 57 to 60).
Example 1 uses the HMO values shown in Figures 1A and 2, whereas example 2 uses the HMOs values shown in Figure 1B. Both examples are disclosed as systems according to the invention.
Even assuming that the concentrations in Figure 1A and 2 (used to prepare example 1) represent the more preferred embodiment, there is no teaching in the application to provide a system which encompasses this embodiment but excludes the concentrations in Figure 1B used to prepare example 2.
Thus, the application does not contain a pointer to the combination of ranges defining the 2′-FL concentrations in claim 1 of the main request.
It is indeed nothing new under the sun that in a selection from a plurality of lists, even when they are converging there is the need for a pointer towards the final selection.
Here the proprietor simply claimed that the selection corresponded to the “preferred” embodiments, but at the same time excluded the “less preferred” ones. Only this statement combined with a plurality of and/or statements shows that final selection was far from following a pointer.
On the procedure
We have here a further example, among many, in which the decision of the OD has been set aside by a board. Such an occurrence has become rather frequent.
In the first half of 2023, this is the case for more than 50% of decisions taken by ODs.