The opponent filed an appeal after the Opposition Division (OD) had maintained the opposed patent in amended form.
The Board tackles the question of whether the invention is sufficiently disclosed.
[2.1] During the first instance opposition proceedings and after filing the notice of opposition, the [opponent] argued that the invention as defined in claim 1 was not sufficiently disclosed. The objections raised in this context were not admitted into the proceedings by the OD as they constituted a new ground of opposition under A 100(b) that was late-filed and not prima facie relevant. This aspect of the decision was challenged by the [opponent].
[2.2] The contested part of claim 1 of the main request refers to a powdered human milk fortifier comprising
- a protein component in a quantity of 24 wt/wt% to 55 wt/wt% of the powdered human milk fortifier,
- a fat component in a quantity of 1 wt/wt% to 30 wt/wt% of the powdered human milk fortifier,
- a carbohydrate component in a quantity of 15 wt/wt% to 75 wt/wt% of the powdered human milk fortifier,
- and “further comprising at least one additional nutrient consisting of calcium, wherein said calcium source is insoluble”.
[2.3] The [opponent’s] first argument with regard to insufficiency of disclosure was that a fortifier of claim 1 containing 75 wt% carbohydrates could not be reproduced, as such a fortifier would comprise more than 100 wt% of ingredients (75 wt% carbohydrates + the minimum level of 24 wt% protein + the minimum level of 1 wt% fat + insoluble calcium source).
[2.3.1] This alleged deficiency was already present in granted claim 2, which depends on claim 1 and relates to the presence of additional nutrients such as calcium. Hence, the [opponent’s] objection could have been raised in the notice of opposition. Therefore, as stated in the OD’s decision, this objection was indeed late-filed.
[2.3.2] This late-filed objection in fact relates to the question of where the boundaries of claim 1 lie with regard to the upper limit of the carbohydrate content. More particularly, to avoid the components of claim 1 adding up to more than 100 wt%, the skilled person has two possibilities to interpret the claim: (i) the upper limit for the carbohydrate amount is in fact below 75 wt%, based on all the components of the fortifier, or, (ii) the upper limit for the amount of carbohydrate is not based on all the components of the fortifier but only on the macronutrients (carbohydrates, proteins and fats) contained therein. The upper limit of the carbohydrate amount is thus ambiguous.
Although the board accepts that, depending on the circumstances, an ambiguity (or lack of clarity) may lead to an insufficiency objection, it should be borne in mind that, as pointed out in T 608/07 [2.5.2], for an insufficiency objection, it is not enough to show that an ambiguity exists. It would normally be necessary to prove that the ambiguity deprives the skilled person of the promise of the invention by not enabling him to obtain the desired effects.
In the present case, however, the ambiguity exists only at the very edge of the scope of claim 1 (the upper limit of the carbohydrate amount), and does not permeate the whole claim. Therefore, the [opponent’s] objection in effect merely relates to the determination of the exact scope of the claim, which is a matter of A 84 rather than A 83. Consequently, in line with the OD’s decision, the [opponent’s] first objection cannot form a prima facie relevant ground of opposition.
[2.4] The [opponent’s] second argument with regard to insufficiency of disclosure was that it is not clear what is meant by “insoluble calcium” in claim 1.
[2.4.1] Again, this deficiency was already present in granted claim 3. Hence, this objection could have been raised in the notice of opposition. Therefore, as set out in the OD’s decision, this objection was late-filed as well.
[2.4.2] Moreover, in the same way as with regard to the upper limit of the carbohydrate amount, this objection relates to the question of where the boundaries of claim 1 lie, this time with regard to the solubility of the calcium source. No evidence has been provided that this alleged ambiguity prevents the skilled person from obtaining the effects aimed at by the claimed invention. Thus, again, the [opponent’s] objection relates to clarity rather than sufficiency of disclosure and for this reason alone the [opponent’s] second objection cannot form a prima facie relevant ground under A 100(b).
[2.4.3] Moreover, with regard to the insoluble calcium source, the opposed patent defines the term “insoluble calcium” in paragraph [0025] as follows:
“The term “insoluble calcium” refers to food grade calcium sources listed in the CRC Handbook of Chemistry and Physics as sparingly soluble in water.”
From this CRC Handbook (D13), it can be deduced that the solubility of those calcium salts that are described in paragraph [0056] of the opposed patent as insoluble (calcium carbonate, calcium citrate, calcium phosphate dibasic and calcium phosphate tribasic) differs from the solubility of typical soluble calcium salts by several orders of magnitude.
In particular, the solubility (expressed in grams per 100 cc) of calcium carbonate is between 0.0014 and 0.0019 (cold and hot water), that of calcium citrate between 0.085 and 0.096, that of calcium dibasic phosphate between 0.0316 and 0.075 and that of calcium tribasic phosphate is 0.002, while e.g. soluble calcium acetate has a solubility between 29.7 and 34.7. The opposed patent thus provides sufficient guidance to make it possible to differentiate between insoluble and soluble calcium sources. Also for this reason, the [opponent’s] objection with regard to the insoluble calcium source does not constitute a prima facie relevant ground of opposition under A 100(b).
[2.5] As regards the exact scope of claim 1 with respect to “75% wt/wt carbohydrate”, this feature would have to be interpreted broadly if it became decisive to be able to distinguish the claimed subject-matter from the relevant prior art. Since, however, this is not an issue in the present case, there is no need to elaborate further on the interpretation of this feature in claim 1.
[2.6] In summary, the board therefore does not see any reason to overturn the OD’s decision not to admit the new ground under A 100(b).
Should you wish to download the whole decision, just click here.
To have a look at the file wrapper, click here.
0 comments:
Post a Comment