T 0099/13 - Parameter and basis

Key points

• Claim 1 is amended to specify the measurement temperature for the viscosity range mentioned in the claim (i.e. adding "at 25 °C").
• The Board: "[It] is important to recall, in line with the case law [], that the assessment of the requirements of Article 123(2) EPC should be done on the same basis as for all other patentability issues (e.g. novelty and inventive step), namely from the standpoint of the skilled person on a technical and reasonable basis avoiding artificial and semantic constructions." 
• The value could be based on the examples wherein it was mentioned that the viscosity measurements were accomplished at 25°C.

T 0099/13 - link 

Main request - amendments

2. With regard to claim 1 of the main request, the disputed point is whether the specification of the temperature for the viscosity condition ("at 25°C") is directly and unambiguously derivable from the application as filed.

2.1 Firstly, the Board sees no reason to consider the condition in claim 1 as originally filed in which no temperature is present ("having a kinematic viscosity of 50 cs or less") as a defective one which needs to be corrected. While it is known that viscosity is strongly dependent on temperature, so that a condition without the specification of the temperature may be unclear, the absence of a temperature cannot be seen as a manifest mistake which must be corrected.

2.2 The case law relating to correction of errors does not therefore apply, so that it is not relevant to establish whether the skilled person would rule out any other interpretation of original claim 1 than the one in which the specification "at 25°C" is added. The fact that that there is no standard temperature in the art for the viscosity measurement, as shown by the respondents with reference to several cited documents, is for the same reason not relevant.

2.3 Secondly, with regard to the present issue as well as to the following ones concerning further amendments, it is important to recall, in line with the case law (see e.g. T 667/08 of 20 April 2012, point 4.1.4; T 1269/06 of 20 September 2007, point 2), that the assessment of the requirements of Article 123(2) EPC should be done on the same basis as for all other patentability issues (e.g. novelty and inventive step), namely from the standpoint of the skilled person on a technical and reasonable basis avoiding artificial and semantic constructions.

2.4 The skilled person, reading claim 1 as originally filed from the standpoint of a technician working in the field, would read the broad condition expressed therein with regard to the viscosity measurement as a condition to be met at the temperature of use of the claimed formulation and would turn to the description to find further information in this respect.

2.5 In the description the skilled person would first find clear statements which confirm this technical reading. In the description of the prior art, when the problems of the prior art are analysed, it is said that "Highly viscous formulations are difficult to manufacture, draw into a syringe and inject subcutaneously" (page 2, lines 4 and 5), clearly indicating that high viscosity values are problematic in the conditions of manufacture and use. Immediately after this analysis, when the scope of the invention is identified, it is said that "The present invention is directed to providing a high concentration protein formulation with reduced viscosity, which is easy to handle and is suitable for subcutaneous administration" (page 3, lines 4 to 6), which specifies that the reduced viscosity is to be achieved in the conditions of handling and use of the formulation.

2.6 When it comes to actual disclosure of temperature values for handling and using the formulation and to the measurement of viscosity, it is specified that the preferred temperature of reconstitution is 25°C (page 37, lines 5 and 6) and the viscosity measurement is accomplished at 25°C in examples 1 to 4, 6 and 7 and at 6°C in example 5 (pages 39 to 42).

2.7 While this information alone is sufficient to conclude that 25°C is the preferred temperature in the application as originally filed at which it is desired that the viscosity condition is met, it is further noted that the only example in which a different temperature is used (example 5 on page 41) is an example which does not fall under claim 1 as originally filed, as the concentration of the protein (rhuMAb E25) of 21 mg/ml is well below the lower value of the range indicated in original claim 1 ("at least about 80 mg/ml").

2.8 On that basis it is concluded that the amended viscosity condition with the specification of the temperature of measurement "at 25°C" is directly and unambiguously derivable from the application as filed.

2.9 None of the additional arguments of the respondents is able to change this conclusion.

2.9.1 The question of which may be the reasons why the measurement is done at 6°C in example 5 is indeed not relevant, as the example does not fall under original claim 1 and as all other examples together with the information in the general part of the description give a basis for the measurement at 25°C.

2.9.2 Further, there is no technical basis for considering the temperature of the viscosity measurement as inextricably linked to other features of the examples. Firstly, the temperature used in the examples is to be read, as analysed above, in conjunction with the general teaching of the application as originally filed. Secondly, there is no technical reason, nor any indication in the application as filed that the desired reduction in viscosity may be dependent on the protein used, so that according to which antibody is chosen, a different temperature of measurement may be required. Finally, with regard to the specific viscometer used in the examples, the fact that different instruments are suitable in different viscosity ranges and have different accuracy (as shown e.g. by D140, D141 and D125) may be relevant, if at all, to the question of clarity and sufficiency, but not to the issue of added matter.

2.9.3 The fact that the temperature of 25°C is not literally disclosed in the context of a cut-off value of 50 mm**(2)/s or less, as the viscosity values in the examples are well below this limit, is also of no relevance in view of the general disclosure of the viscosity condition in the claims and in the description and in view of the disclosure of 25°C as the preferred temperature of use and of measurement of viscosity.

2.9.4 Finally, it is true that by the addition of the temperature a much more limited class of formulations is defined, but this is perfectly acceptable, if, as shown above, a basis for the limitation can be found.

2.10 The conclusion reached for claim 1 of the main request is equally valid for the other claims (claims 7 and 23) in which the specification "at 25°C" is added to the viscosity condition.

[...]

Remittal

4. Although the EPC does not guarantee the parties an absolute right to have all the issues in the case considered by two instances, it is well recognised that any party may be given the opportunity of two readings of the important elements of a case. The essential function of an appeal is to consider whether the decision issued by the first-instance department is correct. Hence, a case is normally referred back if essential questions regarding the patentability of the claimed subject-matter have not yet been examined and decided by the department of first instance.

4.1 In particular, remittal is considered by the boards in cases where a first-instance department issues a decision against a party solely upon some issues which are decisive for the case, and leaves other essential issues outstanding. If, following appeal proceedings, the appeal on the particular issues is allowed, the case is normally remitted to the first-instance department for consideration of the undecided issues (Article 111(1) EPC).

4.2 The observations made above apply in full to the present case. The opposition division decided that the claimed subject-matter did not meet the requirements of

Article 123 EPC, but did not consider further issues, including sufficiency, novelty and inventive step. These issues, however, formed inter alia the basis for the request that the patent be revoked in its entirety and must therefore be considered as essential substantive issues in the present case.

4.3 The respondents who were not in favour of a remittal simply mentioned general circumstances, which normally apply (avoiding prolongation of the period of legal uncertainty, grounds discussed at lengh in writing during opposition) and did not invoke any specific reasons which could be considered by the Board strong enough to justify a deviation from the principles mentioned above.

5. Thus, the Board has reached the conclusion that, in the circumstances of the present case, it is appropriate to remit the case to the opposition division for further prosecution on the basis of the claims of the main request.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The case is remitted to the opposition division for further prosecution.