This is an appeal against the revocation of the patent under consideration by the Opposition Division (OD).
The Board found the main request on file not to comply with the requirements of A 123(2) and then examined the auxiliary request claim 1 of which read (the amendments with respect to claim 49 as filed are underlined):
1. Use of daptomycin for the manufacture of a medicament for treating a bacterial infection in a human patient in need thereof, wherein a dose for said treating is 3 to 10 mg/kg of daptomycin, wherein said dose is repeatedly administered in a dosage interval of once every 24 hours.
Amendments (A 100(c) and A 123(2))
 Claim 1 of this request likewise concerns a dosage regime for treating a bacterial infection with the antibiotic daptomycin and differs from claim 1 of the main request in that the alternative “or once every 48 hours” is deleted. The decision under appeal dealt with the same claim 1 which is at issue here.
 Claim 1 includes the feature “wherein said dose is repeatedly administered” which was present in claim 1 as granted and objected to by [opponent 2] under A 123(2) (A 100(c)). The board shares the OD’s view that the introduction of this feature into claim 1 does not contravene A 123(2). Claim 49 as filed discloses that daptomycin is used “at a dosage interval of once every 24 hours” […]. The board considers that from the indication of a “dosage interval” and of “once every 24 hours” the skilled person would understand directly and unambiguously that the dose of daptomycin is administered more than once, in other words, repeatedly. The board is not persuaded by [opponent 2’s] argument that “repeatedly once every 24 hours” can also mean “that a drug is administered once every 24 hours for one week, then the intake of the drug is interrupted for one week followed by another week of taking the drug once every 24 hours. In other words the intake of the drug at a dosage interval of once every 24 hours can be conducted repeatedly, i.e. with intermissions.” First of all the board notes that claim 1 reads: “wherein said dose is repeatedly administered in a dosage interval of once every 24 hours” and does not read “repeatedly once every 24 hours”. Neither the wording of claim 1 nor the skilled person’s common understanding regarding the administration of antibiotics warrant the interpretation advocated by [opponent 2]. The introduction of the feature “wherein said dose is repeatedly administered” therefore does not result in new technical information which was not present in the application as filed.
 According to the decision under appeal claim 1 however contravened A 123(2) because the dose range from “3 to 10 mg/kg of daptomycin” could not be derived directly and unambiguously from the application as filed. The OD held that the principles developed in decisions T 2/81 and T 201/83 were not applicable to the present case […]. The board comes to a different conclusion than the decision under appeal for the reasons set out below.
 Firstly, the board agrees with the [patent proprietor] that the principles developed in decision T 2/81 are of relevance to the present case. In the case underlying decision T 2/81 the application disclosed a range “from 1 ppb to 10 ppm, preferably from 0.05 to 5 ppm”. The question before the then competent board was whether the range from 0.05 to 10 ppm could be regarded as disclosed. The board held (see decision T 2/81 ) as follows:
“The end-points are specifically named, and the two part-ranges of the general [range] lying outside the preferred range would be unequivocally and immediately apparent to the person skilled in the art. The simple sub-combination of these part-ranges of the concentration values as claimed would not merit novelty as “selection”, so that the restriction does not represent any new subject-matter within the meaning of A 123(2).”
As pointed out by the [patent proprietor], the board reached the claimed range of 0.05 to 10 ppm in two steps. In the first step, it considered that the two part-ranges of the general range lying outside the preferred range (i.e. 1 ppb to 0.05 ppm and 5 ppm to 10 ppm) would be unequivocally and immediately apparent to the person skilled in the art. It then considered that no new matter was introduced by combining the preferred range (0.05 to 5 ppm) with the upper part-range (5 ppm to 10 ppm). According to T 2/81 [headnote 2]:
“The disclosure of a quantitative range of values (e.g. for concentrations or temperatures) together with an included preferred narrower range also directly discloses the two possible part-ranges lying within the overall range on either side of the narrower range. Hence a simple combination of the preferred narrower range and one of these part-ranges is also unequivocally derivable and is supported by the disclosure.”
 The [opponents] submitted that the principles developed in decision T 2/81 were not applicable to situations where the range resulted from the combination of the lower limit of the general range with the lower limit of the preferred range, thus excluding the preferred range (see decision T 1170/02 [4.3]).
 However, the board agrees with the [patent proprietor] that only the first step of the analysis carried out in decision T 2/81 is necessary to arrive directly and unambiguously at the range of 3 to 10 mg/kg of daptomycin. In the present case, claim 49 as filed discloses the use of daptomycin for the manufacture of a medicament for treating a bacterial infection in a patient in need thereof, wherein a dose for such use is 3 to 75 mg/kg of daptomycin at a dosage interval of once every 24 hours. According to dependent claim 52 as filed the dose is 10 to 25 mg/kg. Applying the principles of decision T 2/81 to the present case, the two part-ranges lying within the overall range on either side of the narrower range and hence also directly and unambiguously disclosed to the person skilled in the art are i) a dose of 3 to 10 mg/kg of daptomycin and ii) a dose of 25 to 75 mg/kg of daptomycin. Claim 49 in combination with claim 52 as filed thus disclose the following four ranges of daptomycin doses - 3 to 75 mg/kg, 10 to 25 mg/kg, 3 to 10 mg/kg and 25 to 75 mg/kg - at a dosage interval of once every 24 hours for treating a bacterial infection in a patient in need thereof. The board notes that this finding is in line with earlier case law, see e.g. decision T 727/00 [1.1.3, 1.1.4 and 2.1.2].
 Claim 1 under consideration is directed to a dosage regime based on one of these four ranges for treating a human patient. The [opponents] submitted that the range of 3 to 10 mg/kg daptomycin was not directly and unambiguously disclosed in combination with human patients.
 [… T]he relevant question to be addressed is whether or not restricting the dosage regime to human patients results in the skilled person being presented with technical information which is not clearly and unambiguously set out in the application as filed. The present invention addresses the problem of skeletal muscle toxicity at high doses of daptomycin […] and discloses that once-daily dosing can minimize daptomycin muscle toxicity, while potentially optimizing its antimicrobial efficacy […]. The disclosed methods can be used for human patients in clinical applications and in veterinary applications […]. The skilled person learns from the application as filed […] that in a preferred embodiment daptomycin is administered to a human patient in a dose of 3 to 12 mg/kg every 24 to 48 hours and in an even more preferred embodiment, daptomycin is administered at a dose of 3, 4, 5, 6, 7, 8, 9, 10 or 12 mg/kg once every 24 hours. Furthermore, according to example 4 daptomycin is administered to human subjects at a dose of 4 mg/kg every 24 hours or at a dose of 6 mg/kg every 24 hours without any signs of muscle toxicity. The application as filed therefore points the skilled person to the use of a dose of 3 to 10 mg/kg of daptomycin for the treatment of a bacterial infection in human patients. The board concludes therefrom that the subject-matter of claim 1 does not present the skilled person with technical information which could not be derived clearly and unambiguously from the application as filed.
 Secondly, the board agrees with the [patent proprietor] that also the line of reasoning developed in decision T 201/83 is of relevance to the present case. According to T 201/83 
“(…) an amendment of a concentration range in a claim for a mixture, such as an alloy, is allowable on the basis of a particular value described in a specific example, provided the skilled man could have readily recognised this value as not so closely associated with the other features of the example as to determine the effect of that embodiment of the invention as a whole in a unique manner and to a significant degree”.
 In the case underlying decision T 201/83 the fact that the value was disclosed in an example was insofar of relevance as the board had first to establish that the value disclosed in the context of an example could be considered separately from the other features disclosed in the example. This board cannot however derive from decision T 201/83 the requirement that the value on which a sub-range is to be based has necessarily to be disclosed in an example. Rather it appears that what is required is that for the skilled person the value has to be recognisable as a singularity, as in decision T 201/83 within or at the end of a range of possibilities which may mark an end-point for a particular sub-range (cf. decision T 201/83 [8-9]).
 In the present case […] the description as filed discloses that:
“In a more preferred embodiment, daptomycin is administered to a human patient in a dose of 3 to 12 mg/kg every 24 to 48 hours.”
Furthermore, […] the application as filed discloses that
“In an even more preferred embodiment, daptomycin is administered in a dose of 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 mg/kg once every 24 hours.”
The board considers that this latter disclosure makes the dose of 10 mg/kg of daptomycin every 24 hours recognisable as a point within several possibilities. Therefore, in view of the observations above […] it can be used as the end-point to define a sub-range. From the following paragraph […] it is moreover clear that the dosage regime applies to the treatment of a bacterial infection.
 The [opponents] assert that the extraction of the value 10 mg/kg of daptomycin would correspond to a qualitative choice. However, a qualitative choice would require a selection from a variety of several possibilities wherein the selected possibility is qualitatively distinct from the other possibilities. In the present case the dose range of 3 to 12 mg/kg of daptomycin, each of the doses of the list of doses of 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 mg/kg of daptomycin and hence also the dose of 10 mg/kg of daptomycin have been disclosed in connection with a dosing interval of 24 hours for the treatment of a bacterial infection in humans. Thus the range to be amended, i.e. 3 to 12 mg/kg of daptomycin, the value used for restricting the original range, i.e. 10 mg/kg of daptomycin, and the amended range, i.e. 3 to 10 mg/kg of daptomycin are all qualitatively identical. Therefore the restriction of the dose range from 3 to 12 mg/kg of daptomycin every 24 to 48 hours to 3 to 10 mg/kg of daptomycin every 24 hours is in the present case to be considered as a quantitative rather than a qualitative limitation of a dose range, i.e. it is a limitation that is directly and unambiguously derivable from the application as filed and that does not represent the skilled person with new technical information. Thus, the board concludes that […] the description as filed also provides a basis for claim 1 of the auxiliary request.
 For the reasons indicated above […] the board decides that the auxiliary request complies with the requirements of A 123(2) (A 100(c)).
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