Opinion Issued: July 5, 2019 [*]
Appeals from the United States District Court for the
District of Delaware in Nos. 1:12-cv-00106-LPS,
1:12-cv-00274-LPS, 1:12-cv-00275-LPS, 1:13-cv-00225-LPS,
Chief Judge Leonard P. Stark.
P.D. Wilcox, Desmarais LLP, New York, NY, argued for
plaintiff-appellant. Also represented by John M. Desmarais;
Peter Curtis Magic, San Francisco, CA.
Matthew Wolf, Arnold & Porter Kaye Scholer LLP,
Washington, DC, argued for defendants-appellees Roche
Molecular Systems, Inc., Roche Diagnostics Corporation, Roche
Diagnostics Operations, Inc., Roche NimbleGen, Inc., Becton,
Dickinson and Company, Becton Dickinson Diagnostics Inc.,
GeneOhm Sciences Inc.
C. O'Quinn, Kirkland & Ellis LLP, Washington, DC,
argued for defendants-appellees Abbott Laboratories, Abbott
Molecular, Inc. Also represented by Michael Pearson, Jason M.
Wilcox; James F. Hurst, Amanda J. Hollis, Chicago, IL;
Benjamin Adam Lasky, New York, NY.
Khan, Wilmer Cutler Pickering Hale and Dorr LLP, New York,
NY, for defendants-appellees Roche Molecular Systems, Inc.,
Roche Diagnostics Corporation, Roche Diagnostics Operations,
Inc., Roche NimbleGen, Inc., Becton Dickinson and Company,
Becton Dickinson Diagnostics Inc., GeneOhm Sciences Inc. Also
represented by Robert J. Gunther, Jr., Christopher R. Noyes;
William G. McElwain, Thomas Saunders, Washington, DC.
Prost, Chief Judge, Reyna and Wallach, Circuit Judges.
Life Sciences, Inc. ("Enzo") appeals the decision
of the U.S. District Court for the District of Delaware
granting summary judgment against Enzo and holding that the
asserted claims are invalid for lack of enablement.
affirm as to non-enablement and do not reach the other issues
presented on appeal.
acid ("DNA") and ribonucleic acid ("RNA")
are nucleic acids. They are made of a series of building
blocks, called nucleotides, linked together in a chain. A
single nucleotide is made up of a sugar, a phosphate, and a
nitrogenous base. DNA nucleotides have one of four
nitrogenous bases: adenine (A); guanine (G); cyto-sine (C);
and thymine (T). RNA has the same bases, except it uses
uracil (U) instead of thymine (T).
polynucleotide refers to multiple nucleotides linked together
in a chain. The nucleotides located at each end of a
polynucleotide chain are referred to as terminal
nucle-otides. All other nucleotides in a polynucleotide chain
are referred to as internal nucleotides.
strands of polynucleotides can pair with each other, i.e.,
hybridize, through hydrogen bonding between the bases on each
polynucleotide strand. The bases T and U pair with A, while G
pairs with C. This is referred to as complementary base
pairing or "Watson-Crick base pairing," and this
pairing is how the now-familiar double helix shape is formed.
Two polynucleotide strands will hybridize if the arrangement
of nucleotides in each strand is such that enough bases can
pair with each other. For example, whether two strands will
hybridize depends in part on the number of complementary base
pairs that exist between the two polynucleotides.
techniques are used to detect the presence of certain nucleic
acid sequences of interest, i.e., target sequences, such as
genetic alterations. In such procedures, scientists use a
hybridization "probe"-i.e., a labeled
poly-nucleotide that is hybridizable and remains detectable
after hybridization occurs-that is sufficiently complementary
to the target sequence. The probe will hybridize with the
target sequence if the target sequence is present, and the
label on the probe then allows scientists to detect the
acid hybridization was well understood by June 1982, which is
the claimed priority date of the patents at issue in this
appeal. The prevailing method of labeling probes at that time
was via radioactive labeling. Radioactive labeling generally
involved replacing certain atoms in the nucleotide sequence
with corresponding radioactive isotopes.
labeling was just developing at the time of the claimed
inventions. In 1981, Dr. David Ward and others at Yale
University successfully developed a non-radioactive probe by
attaching a label to a polynucleotide via a chemical linker
at a base position of a nucleotide. See J.A. 4129-33
(publication by Dr. Ward and others titled "Enzymatic
synthesis of biotin-labeled polynucleotides: Novel nucleic
acid affinity probes"). Dr. Ward demonstrated that
attaching labels at certain positions of the nu-cleotide
("the Ward positions") would not disrupt the
polynucleotide's ability to hybridize and be detected
December 1981, Enzo licensed the exclusive rights to the
patent portfolio covering Dr. Ward's discovery.
See J.A. 4258-75. Shortly thereafter, in June 1982,
Enzo filed a patent application covering non-radioactive
labeling at additional positions on a nucleotide. The two
patents in this appeal issued from applications filed in 1995
that claim priority from this 1982 application.
patents in this appeal generally relate to the use of
non-radioactively labeled polynucleotides in nucleic acid
hybridization and detection applications. The patents share