T 1803/09 – Wrong Approach

The applicant filed an appeal against the decision of the Examining Division refusing its application.

Claim 1 of the main request before the Board read:

1. A method for predicting cardiac mortality in a chronic congestive heart failure (CHF) patient, said method comprising the steps of:

(A) assaying for the presence of a cardiac marker of cell injury in a body fluid sample drawn from said patient using:

a first antibody that specifically binds to a cardiac marker of cell injury, wherein said cardiac marker of cell injury is cardiac Troponin-I; and

(B) assaying for the presence of a marker of organ adaptation in a body fluid sample drawn from said patient using:

a second antibody that specifically binds to said marker of organ adaptation, wherein said marker of organ adaptation is selected from the group consisting of ANP, N-terminal ANP, BNP, N-terminal BNP and CNP,

wherein when both said marker of cell injury and said marker of organ adaptation are present in said sample at significantly increased levels as compared to control samples from normal individuals, said patient is predicted to have an increased prognosis of cardiac mortality. (my emphasis)

There was agreement on the fact that the subject-matter of this claim was not explicitly disclosed in the application as filed, but the applicant pointed out that the disclosure was implicit.

The Board won’t have it:

[7] The appellant does not contest the absence of an explicit disclosure of the subject-matter of claim 1 […] in the application as filed, but its argumentation relies on an implicit disclosure of this subject-matter which, in the appellant’s view, is directly and unambiguously derivable from the application as filed when taken as a whole, the specific teachings of the Example assisting the skilled person to understand the general disclosure (T 40/97), and from the fact that said disclosure and teachings would prompt the skilled person to seriously contemplate the use of the claimed combinations of markers in the method of the Main Request or of Auxiliary Requests 1 to 3 in chronic CHF patients (T 187/91 and T 296/96).

[7.1] The board agrees with the appellant that the entire disclosure of the application as filed is focused on the heart as the organ of study and, in particular, on CHF. However, as stated in the application as filed when acknowledging prior art concerned with CHF […], various and different causes may be at the origin of CHF and, although some of them may be shared by both acute and chronic CHF, these two conditions are differentiable and distinguished – albeit, admittedly, broadly defined. Thus, contrary to the appellant’s view, the term “CHF” as used in the application as filed can not always be, only and exclusively, equated to “chronic CHF”. Although the former term includes the latter, it is much broader and includes other conditions, such as “acute CHF”.

[7.2] The board does not share the appellant’s view that the tests and methods disclosed in the application as filed for use in CHF patients are appropriate only for “chronic CHF” and not for “acute CHF”. Early, preliminary diagnosis methods may distinguish and differentiate patients with one of these conditions. Likewise, methods may be developed for monitoring the long-term management (efficacy of therapeutic agents) of each of these two CHF conditions. Indeed, the references in the application as filed to “methods for distinguishing CHF” may be interpreted as referring to methods for distinguishing CHF from other heart failures as well as methods for distinguishing – at an early, preliminary stage – different CHF conditions. If at all, these references are ambiguous. It is worth noting here that not all tests and methods referred to in the application as filed are necessarily concerned with the prediction of CHF mortality. A test for early, preliminary diagnosis for CHF may well inform about the specific type of CHF condition but may be of limited value, or of no value at all, for the prediction of the severity or mortality of this condition.

[7.3] Although the sole method exemplified in the application as filed refers to criteria for selecting markers of cell injury and organ adaptation having elevated levels in CHF patients, it is also explicitly stated that

“(h)owever in patients with chronic heart failure, it is unclear whether there is a relationship between either elevated levels of cTnI alone, or in conjunction with elevated levels of pro-ANP, and survival” (emphasis added by the board) […].

Although this uncertainty is set aside for the specific marker combination disclosed in the Example, the board does not see the results reported in the Example for cTnI and pro-ANP to be directly and unambiguously transferable to all other possible combinations of markers fulfilling said criteria. Indeed and contrary to the appellant’s view, the same uncertainty remains for other markers, their possible combination does not necessarily have to provide similar or identical results to those obtained with cTnI and pro-ANP. If at all, the sentence referred to above is ambiguous.

The results shown in the Example may well render the combination of other markers obvious or, in other words, they may be for the skilled person obvious to try but this is not a criteria to apply under A 123(2). These combinations are not a direct and unambiguous consequence of the results shown in the Example nor a consequence directly and unambiguously derivable from the application as filed when taken as a whole.

[7.4] Thus, not all tissue or organ failures, damages or diseases within the above identified group A) can be directly and unambiguously equated to “chronic CHF” […]. Likewise, not all subject-matter within the above identified group C) can be directly and unambiguously understood as relating to mortality prediction for chronic CHF patients […]. Moreover, on the basis of the results shown in the Example of the application as filed, not all possible marker combinations within the above identified group B) can be seen as being directly and unambiguously interchangeable in the method of that Example […]. The identification of three groups of interrelated subject-matter and the different levels of generalization for each of them is not artificial and inappropriate but it is clearly derivable from the application as filed taken as a whole.

When reading the application as filed, the skilled person would not recognize that the feature “chronic CHF” is equally applicable to “all marker combinations” disclosed in the application, let alone that all marker combinations might be useful “for predicting cardiac mortality” in a patient with this specific CHF condition. This reading can only arise when using the disclosure of the application as filed as a large reservoir from which parts are arbitrarily taken and combined. Such a reading, however, is not allowable under A 123(2) […].

[8] Thus, there is no implicit disclosure in the application as filed of the subject-matter of claim 1 […].

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