• Jul 10 2019
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  • Category: CAFC Updates

The Patent Trial and Appeal Board found claims of Quake’s Patent and pending Application unpatentable for lack of written description under 35 U.S.C. § 112 as part of three interference proceedings. The claims cover a method of determining the presence of aneuploidy (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. The claims recite a random MPS method for the detection step, meaning that all the DNA in the sample is sequenced, as opposed to sequencing specific, targeted sequences. Quake’s specification, however, only expressly describes detection of target sequences in its thirty-plus column specification.  The primary issue on appeal is whether the patent specification shared by Quake’s patent and application sufficiently describes using random MPS to determine fetal aneuploidy, such that it meets the requirements of § 112. The CAFC notes that given the specification’s repeated discussion of targeted sequencing, a bare citation to a reference which provides some disclosure of MPS of DNA fragments selected randomly, and use of the phrase “about 30 bp of random sequence in-formation are needed to identify a sequence” in the context of this patent would be a highly elliptical, cryptic way to communicate possession of a second method of sequencing to determine fetal aneuploidy. The CAFC concludes that substantial evidence supports the Board’s finding that those two items together are not adequate to convey using random MPS to determine fetal aneuploidy as claimed and thus affirms the Board’s three interference decisions.

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