It is “not enough that the only embodiments, or all of the embodiments, contain a particular limitation to limit a claim term beyond its ordinary meaning.” Even if a specification has only one embodiment, its claims will not be confined to that example “unless the patentee has demonstrated a clear intention to limit the claim scope using words or expression of manifest exclusion or restriction.” Further, although last in their list of evidence, it is perhaps noteworthy here that the court highlighted what can only be classified as a boilerplate disclaimer in the specification: “Instead of a clear intention to limit the claims to the embodiments in the examples, here the specification states that the examples ‘do not in any way limit the scope of the invention.’”
Background / Facts: The patent here is directed to a less invasive method for identifying fetal genetic defects by analyzing maternal fluid that had commonly been discarded as medical waste – the maternal plasma or serum. These new tests present fewer risks and provide a more dependable rate of abnormality detection. In this regard, the claims recite detecting fetal genetic characteristics by analyzing cffDNA obtained from a maternal blood sample to look for certain “paternally inherited nucleic acids.”
Issue(s): Whether the claimed “paternally inherited nucleic acid” sequence needs to be known in advance to have been received only from the father and not possessed by the mother, such that infringement can only occur after a user knows the father’s gene sequence (for example, through genotyping).
Holding(s): No. “At the outset, the claim language recites only the term ‘paternally inherited nucleic acid.’ This term does not incorporate any inherent meaning about the timing or method of detecting the paternal characteristic. Rather this claim term states only the origin of that particular nucleic acid however or whenever it may be identified. This language does not require pretesting knowledge of the father’s genetic sequence. The phrase ‘paternally inherited nucleic acid of fetal origin’ connotes only nucleic acid that originates from the fetus and is inherited from the father. Had the applicant wanted to limit the claim to those nucleic acids known in advance to have come from the father, it easily could have done so, as the district court’s insertion of the ‘known in advance’ requirement shows. The applicant, however, did not limit the term in the claim.”