Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

The Board of Trustees of Leland Stanford Junior University v. The Chinese University of Hong Kong

United States Court of Appeals, Federal Circuit

June 27, 2017


         Appeal from the United States District Court for the Northern District of California in No. 3:12-cv-00865-SI, Judge Susan Y. Illston.

          Edward R. Reines, Weil, Gotshal & Manges LLP, Redwood Shores, CA, argued for plaintiff-appellant. Also represented by DEREK C. WALTER, MlCHELE Gauger.

          Charles E. Lipsey, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Reston, VA, argued for defendant-appellee. Also represented by Steven O'Connor; Jennifer Swan, Robert F. McCauley, Jeffrey Daniel Smyth, Lily Lim, Palo Alto, CA; Howard Warren Levine, Washington, DC.

          Before O'MALLEY, Reyna, and Chen, Circuit Judges.

          O'MALLEY, Circuit Judge.

         The Board of Trustees of the Leland Stanford Junior University ("Stanford") appeals from orders of the Patent Trial and Appeal Board ("Board") in three interference proceedings between Stanford and the Chinese University of Hong Kong ("CUHK"). In all of these proceedings, the Board found that Stanford's claims were unpatentable for lack of written description. See Quake v. Lo, No. 105, 920 (P.T.A.B. Apr. 7, 2014); Lo v. Quake, No. 105, 923 (P.T.A.B. Apr. 7, 2014); Lo v. Quake, No. 105, 924 (P.T.A.B. Apr. 7, 2014).[1] Because we conclude that the Board relied on improper evidence to support its key findings and did not cite to other substantial evidence to support its findings, we vacate the Board's interference decisions and remand for further proceedings.

         I. Background

         A. Technology and Patents

         This appeal concerns testing methods for fetal aneu-ploidies, conditions in which a fetus either has an abnormally high number of chromosomes (e.g., Down's syndrome, a result of trisomy 21) or an abnormally low number of chromosomes (e.g., Turner's syndrome, a result of a missing copy of an X chromosome). Prior to the methods developed by the inventors involved in this appeal, physicians typically diagnosed fetal aneuploidies using invasive amniocentesis or chorionic villus sampling procedures. Doctors used less invasive testing methods for identifying aneuploidies, such as ultrasonography and biochemical marker detection, but these methods had suboptimal diagnostic accuracy.

         The two competing inventors in the underlying interferences on appeal-Stanford professor Stephen Quake and CUHK professor Dennis Lo-both developed methods for diagnosing aneuploidies using cell-free fetal DNA ("cff-DNA") from maternal blood samples. In 1997, Lo and a colleague discovered that cff-DNA circulates in maternal blood in small amounts. This discovery made possible new prenatal screening techniques for chromosomal and other abnormalities, but researchers developing techniques for assaying cff-DNA had to overcome interference from maternal DNA in the maternal blood sample.

         In 2006, Quake developed a "digital analysis" method to detect small changes in the quantity of an aneuploid chromosome relative to the quantity of one or more normal chromosomes, without distinguishing between maternal and fetal DNA. '018 patent, col. 1, 11. 46-60; col. 2, 11. 7-9; col. 7, 11. 46-61. Quake describes "a method of differential detection of target sequences in a mixture of maternal and fetal genetic material." Id. col. 4, 11. 43-45. The '018 specification explains that the approach "involves the separation of the extracted genomic material into discrete units so that the detection of a target sequence (e.g., chromosome 21) may be simply quantified as binary (0, 1) or simple multiples, 2, 3, etc." Id. col. 1, 11. 49-52.

         Quake's specification outlines the four steps in his method: (1) obtaining a maternal tissue sample, preferably blood; (2) distributing single DNA molecules from this sample to a number of discrete reaction samples; (3) "[d]etecting the presence of the target in the DNA in a large number of reaction samples"; and (4) performing "[quantitative analysis of the detection of the maternal and fetal target sequences." Id. col. 8, 1. 35-col. 9, 1. 6. The method requires a large number of samples, as only a small amount of cff-DNA is present in a maternal sample. The specification clarifies that the digital PCR technique, in which a known target DNA sequence in a reaction well is amplified by target-specific primers, is the preferred embodiment for amplifying and detecting target sequences.

         The capabilities of second-generation massively parallel sequencing ("MPS") are useful for performing Quake's method, as this method can process large numbers of DNA samples simultaneously. Quake's specification discloses that second-generation MPS can be used for counting chromosomes through DNA sequencing using the Illumina sequencing platform. Id., col. 19, 1. 59-col. 20, 1. 3. MPS can be performed by "random" or "targeted" methods. In the random format, all DNA in a sample is linked to a leader sequence and amplified using a primer complementary to the leader. Appellee Br. 10. In the targeted format, the target sequence is specifically amplified, and then sequenced.

         Quake claimed his method in an application filed on February 2, 2007; this application issued as U.S. Patent No. 7, 888, 017 ("the '017 patent"). Quake filed continuation application no. 12/393, 803 ("the '803 application") in February 2009. This continuation application issued as the '018 patent at issue in this appeal. The '017 and '018 patents share the same specification.

          The original claims of Quake's '803 application explicitly recited methods that required the detection of "target sequences." For example, claim 1 of the '803 application read:

1. A method of differential detection of target sequences in a mixture of maternal and fetal genetic material, comprising the steps of:
a) obtaining maternal tissue containing both maternal and fetal genetic material;
b) distributing the genetic material into discrete samples, each sample containing on average not more than about one target sequence per sample;
c) measuring the presence of different target sequences in the discrete samples; and
d) analyzing a number of the discrete samples sufficient to obtain results distinguishing different target sequences.

J.A. 3253 (emphasis added).

         In 2011, Quake cancelled all pending claims in the application which later issued as the '018 patent, and added new claims.[2] A representative later-added claim from the '018 patent states:

1. A method for determining presence or absence of fetal aneuploidy in a maternal tissue sample comprising fetal and maternal genomic DNA, wherein the method comprises:
a. obtaining a mixture of fetal and maternal genomic DNA from said maternal tissue sample;
b. conducting massively parallel DNA sequencing of DNA fragments randomly selected from the mixture of fetal and maternal genomic DNA of step a) to determine ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.