Quake v. Lo

The Patent Trial and Appeal Board found four claims of Quake’s patent and Claim 25 of its Patent Application unpatentable for lack of written description, 35 U.S.C. 112. The claims cover a method of determining the presence of a chromosomal abnormality in fetuses by using massively parallel sequencing (MPS) technology to sequence DNA fragments from a sample of the mother’s blood that contains both maternal and fetal DNA, identifying what chromosomes those DNA fragments come from based on their sequences, and determining if the test chromosome is over- or under-represented in the sample as compared to a reference chromosome. The claims recite a random MPS method for the detection step--all of the DNA in the sample is sequenced, as opposed to sequencing specific, targeted sequences. The Federal Circuit affirmed. The written description requirement prevents an applicant from later asserting that he invented that which he did not; it is particularly important when, as here, claims are added later during prosecution in response to developments by others. The first time Quake tried to cover random MPS with this specification was after the publication of another patent application directed to random MPS: Quake then canceled all his pending claims and replaced them with claims covering random MPS, creating a mismatch between the claims and the originally filed specification. The Board did not abuse its discretion in declining to reopen the record to admit expert testimony from another proceeding. View "Quake v. Lo" on Justia Law