IP Law Daily PTAB relied on improper evidence in invalidating Stanford’s fetal DNA testing methods
Tuesday, June 27, 2017

PTAB relied on improper evidence in invalidating Stanford’s fetal DNA testing methods

By Thomas Long, J.D

Decisions by the Patent Trial and Appeal Board in three interference proceedings between Stanford University and the Chinese University of Hong Kong ("CUHK")—in which the Board found that methods of testing for fetal aneuploidies in DNA samples drawn from maternal blood were unpatentable for lack of written description—have been vacated by the U.S. Court of Appeals for the Federal Circuit. The Board relied on improper evidence to support its key findings and did not cite to other substantial evidence to support its findings, the Federal Circuit held (Board of Trustees of Leland Stanford Junior University v. Chinese University of Hong Kong, June 27, 2017, O’Malley, K.).

Stanford technology. The technology at issue concerned testing methods for fetal aneuploidies, conditions in which a fetus either has an abnormally high number of chromosomes (such as Down’s syndrome) or an abnormally low number of chromosomes (such as Turner’s syndrome). Competing inventors—Stanford professor Stephen Quake and CUHK professor Dennis Lo—developed methods for diagnosing aneuploidies using cell-free fetal DNA ("cff-DNA") from maternal blood samples. The technology required the development of means to detect and screen out maternal DNA from the fetal DNA in the blood sample. Quake filed a patent application outlining the steps of a testing method using the technology he developed, which issued as U.S. Patent No. 7,888,017 ("the ’017 patent"). Quake filed a continuation application that issued as U.S. Patent No. 8,008,018 ("the ’018 patent"), the patent at issue in this appeal. The two patents shared the same specification. Key to the patented method was a limitation calling for "conducting massively parallel DNA sequencing of DNA fragments randomly selected from the mixture of fetal and maternal genomic DNA" to determine the sequence of the DNA fragments (emphasis added).

CUHK technology. The method developed by Lo also involved "random sequencing," but it used random massively parallel sequencing ("MPS") and did not require the detection of specific target sequences. Lo filed an application describing the "random sequencing" method. When Quake discovered that CUHK had claimed the random sequencing method, Quake cancelled the original claims in the application that later became the ’018 patent and added new claims that, for the first time, explicitly covered random MPS methods. CUHK claimed that Quake’s application copied claims from Lo. Stanford contended that random MPS was disclosed in the specification and supported the later-filed claims.

Interferences. Quake and Lo requested interferences to determine who invented the random sequencing method, and when. The USPTO declared three interferences between Quake’s patents and applications and Lo’s patents and applications. In each proceeding, Lo attacked the Quake ’018 patent and a later-filed application ("the ’833 application") as unpatentable for lack of written description. The Board granted CUHK’s written description motion in all three interferences and found that Quake’s claims were unpatentable. Specifically, the Board found that the specification disclosed "targeted" rather than "random" sequencing, and the specification would not have indicated to one of ordinary skill in the art that Quake was in possession of the claimed random MPS method. Stanford appealed to the federal district court for the Northern District of California. After discovery was conducted in the district court case, the case was transferred to the Federal Circuit under jurisdictional provisions set forth by the America Invents Act, which abolished the right of parties to bring civil actions in district court under 35 U.S.C. §146 for review of Board decisions in interferences declared on or after September 16, 2012.

Role of district court discovery. Stanford argued that the information elicited during discovery in the district court materially altered what the Board understood in reaching its decisions. However, in the court’s view, Stanford’s attempt to include evidence elicited during the district court proceedings was inappropriate because the activities in the district court were a nullity when the district court lacked subject matter jurisdiction to consider a matter. Federal Circuit review of a Board decision had to be confined to the "four corners" of the record before the Board.

Written description. The question of whether a patent claim satisfied the written description requirement of 35 U.S.C. §112, paragraph 1, depended on whether the description "clearly allow[ed] persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed." The test required an objective inquiry into the specification as it would have been understood at the time of filing. The court noted that substantial evidence supported a finding that the specification satisfied the written description requirement when "the essence of the original disclosure" conveyed the necessary information—"regardless of how it" conveyed such information, and even when the disclosure’s words were open to different interpretations.

In this case, the parties disputed whether the Board correctly determined that the ’018 patent did not disclose the random massively parallel sequencing of nucleic acid sequences claimed in the later-added claims, such that a person of skill in the art would have concluded that the Quake inventors were in possession of the method claimed. The parties disagreed as to whether references to certain products made by Illumina, Inc., adequately disclosed random MPS.

The Board relied on expert witness testimony to conclude that the ’018 patent lacked sufficient written support. The expert’s testimony that the Illumina platform taught only targeted, not random, sequencing purportedly was supported by documents related to a certain DNA sequencer ("Roche 454 sequencer") and other "published references." According to the Federal Circuit, the Board erred in relying on the expert’s testimony that was based on those references. Both the expert and the Board failed to cite evidence of targeted or random sequencing on the Illumina platform prior to Quake’s filing date. Although the expert pointed to two post-dated references that discussed the use of targeted sequencing methods on the Illumina platforms, the Board did not cite to or rely upon these references to support its decision. Several other references cited by the expert did not discuss the Illumina platform. The expert and CUHK did not explain why the evidence related to the Roche 454 sequencer—a first-generation MPS platform that differed from the Illumina platform—said anything about the Illumina platform’s sequencing capabilities. In addition, the expert’s testimony did not preclude the possibility that a person of skill at the relevant time could have understood the discussion of MPS in the ’018 patent to refer to either targeted or random sequencing.

Accordingly, the Board’s decisions were vacated, and interferences were remanded for the Board to reconsider whether Quake’s patents and applications satisfied the written description requirement.

The case is No. 2015-2011.

Attorneys: Edward R. Reines (Weil, Gotshal & Manges LLP) for Board of Trustees of the Leland Stanford Junior University. Charles E. Lipsey (Finnegan, Henderson, Farabow, Garrett & Dunner LLP) for The Chinese University of Hong Kong.

Companies: The Chinese University of Hong Kong; Board of Trustees of the Leland Stanford Junior University

MainStory: TopStory Patent FedCirNews

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