EP 3 456 844 B1 relates resolving genome fractions using polyphormism counts in order to detect chromosomal abnormality, aneuploidy, and aberration from blood samples in free floating foetal DNA.
EP 3 456 844 B1 is a divisional of EP 3 078 752 and of EP 2 697 392.
Brief outline of the case
The opposition was rejected and the opponent appealed.
The opponent contested priority, N and IS.
Contrary to the OD, the bord decided that the priority was not valid. The status of an interfering application, D9, changed from PA under Art 54(3) to PA under Art 54(2).
Claim 1 as granted was therefore lacking IS.
As the AR were not properly substantiated, the patent was revoked.
The method at stake comprises, inter alia, two steps:
(a) extracting DNA from a sample of the bodily fluid
(b) sequencing the extracted DNA
The OD’s decision
The OD held that the notions “collecting DNA from a sample of bodily fluid” and “extracting DNA from a sample of bodily fluid” were technically equivalent and thus interchangeable.
The OD concluded therefore that the priority was valid and that D9 could only be considered as PA under Art 54(3).
The board’s decision
The board considered that the disclosure referenced by the OD and the proprietor in the priority document broadly referred to the technical step of “collecting” or “obtaining” DNA.
Such a technical step does not have the same technical informational content as a technical step of “extracting” DNA.
Indeed, the expression “extracting DNA” implies that DNA of a maternal and foetal genome is isolated from a sample, i.e. is separated from other components of the sample, such as proteins, lipids, etc., thus involving separation.
By contrast, the expressions “collecting DNA” and “DNA obtained from” do not necessarily imply such isolation or separation.
These expressions are thus indeed not technically equivalent and interchangeable.
Consequently, the skilled person would not directly and unambiguously derive the feature “extracting DNA from a sample of bodily fluid” from the disclosure of the notion “collecting DNA from a sample of bodily fluid”.
The feature of extracting DNA from a sample of a bodily fluid cannot be interpreted as an implicit technical requirement for the subsequent sequencing step (b), i.e. “sequencing the extracted DNA with a nucleic acid sequencer under conditions that produce DNA segment sequences containing one or more polymorphisms”.
The board added that, for example, a PCR may be performed directly on the sample to amplify the DNA contained in it for sequencing. Whilst the quality of the PCR may improve if the template DNA is extracted before the PCR, such an extraction step is not technically mandatory.
The board concluded that the skilled person would not directly and unambiguously derive step (a) of claim 1 from the disclosure of the priority document.
Consequently, the subject-matter of claim 1 was not entitled to claim the priority date as the effective date of the claim.
Comments
Collecting a blood sample from a person, which manifestly contains DNA, does by no means imply that the DNA is necessarily extracted from the sample.
On the procedure
D9=WO 2012/019200 is classified in IPC C12Q1/68 and in CPC C12Q1/6809 (US); C12Q1/6827 (EP, US); C12Q1/6862 (EP, US).
EP 3 456 844 B1 is classified in IPC C12Q1/68, C12Q1/6809, C12Q1/6827 and in CPC C12Q1/6809, C12Q1/6827, C12Q1/6876.
There is thus no apparent reason why D9 was not mentioned in the ESR as E document, whereby the ESR metions only 3 A documents.
The first divisional, EP 3 078 752 was revoked by an OD, without subsequent appeal.
D9=WO 2012/019200 was mentioned as D13 in those proceedings in which the OD considered the priority was valid and D9=D13 PA under Art 54(3).
The parent application EP 2 697 392, was not opposed.
A change of status of PA from Art 54(3) to Art 54(2) is a favourite game in Paper C at the EQE.
It is much less frequent in real life.
Comments
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