Key points
- This is a case about sufficiency.
- "The claim is directed to a method for the identification of microbial and non-microbial infectious pathogens in whole blood by mass spectrometry. The pathogens are cultured in the whole blood by incubation and afterwards are centrifuged into pellets and subjected to mass spectrometric identification. In order to remove the particles contained in the body fluid, i.e. in the whole blood, the method further includes "additional steps in order to destroy and remove the body fluid particles". These steps are not further defined in the claim.
8. In order to carry out the claimed method, the skilled person must hence know, inter alia, with which additional steps the recited destruction and removal of the blood particles can be achieved such that an identification of any microbial and non-microbial infectious pathogen possibly present in the whole blood by mass spectrometry can be achieved."
"[the application] contains a single hypothetical example in which the sample is whole blood infected by microbes (paragraph [63] of the earliest application). There, it is proposed to destroy and remove the blood particles by firstly separating the pathogens together with the blood particles by centrifugation and then dissolving the pellet in distilled water to destroy the blood particles by osmosis while leaving the microbes intact.
"However, this method does not work, as evident from document D9, which discusses, in paragraphs [19] to [22], the teaching in the earliest application.
"paragraph [22] of D9 [mentions that] "experiments carried out in the applicant's laboratory with this method of adding distilled water did not succeed in providing sufficiently clean centrifuge deposits, even when the washing and centrifuging processes were repeated a few times. Even if the deposits did not retain a slightly reddish color, superimpositions with human protein signals always interfered with the microbial protein signals from these deposits to such an extent that an identification becomes uncertain" (paragraph [22] of D9)."
"Therefore document D9 is evidence that the single hypothetical example described for the claimed method in paragraph [63] of the earliest application is unsuitable to identify microbes in infected whole blood, let alone any microbial and non-microbial pathogens in a whole blood sample. In view of this and in the absence of any evidence that the skilled person could have remedied this deficiency by common general knowledge, it must be concluded that the skilled person could not carry out the claimed method without undue burden at the effective filing date of the application."
D9 is a post published patent application. The proprietor of the patent in suit is the same as the applicant of D9.
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