Patent revoked for added matter. (Article 138(1)(c) EPC, Article 65(2) UPCA)
The skilled person does not directly and unambiguously derive from Claim 1, t
hat the claimed method for quantifying an expression level of a target gene refers to a target gene “in a FFPE tissue sample of human breast cancer tissues” and that the endogenous reference gene for the normalisation of the target gene is OAZ1.
Claim 25 refers to a method for quantifying an expression level of a target gene without mentioning that the target gene is “in a FFPE tissue sample of human breast cancer tissues”. Other claims also contain no indication that the method according to claim 25 refers to a method for quantifying an expression level of a target gene “in a FFPE tissue sample of human breast cancer tissues”.
Nor can the person skilled in the art derive directly and unambiguously from the other disclosure content that this belongs to the invention.
The application also does not clearly and unambiguously disclose that OAZ1 is used as the (sole) reference gene for normalizing the expression level of a target gene in a FFPE breast cancer sample.
The disclosure of a feature as such is not sufficient. It is necessary that it be directly and unambiguously disclosed as belonging to the invention.
No implicit disclosure can be assumed .
It is not apparent that the expression stability of OAZ1 required for normalization is a clear and unambiguous consequence of what is explicitly mentioned. Subclaims 2 and 3 also extend beyond the content of the parental application as filed for the same reasons as claim 1.
Application to amend the patent based on Auxiliary Requests 1,2 or 3 refused. (Rule 30 RoP).
Each of these Auxiliary Requests extends beyond the content of the application as filed.
IPPT20251219, UPC CFI, LD Munich, GXB-Bio Corporation v Myriad
