Enzo Life Sciences, Inc. v. Becton, Dickinson and Co., 081619 FEDFED, 2018-1232
|Docket Nº:||2018-1232, 2018-1233|
|Opinion Judge:||Lourie, Circuit Judge.|
|Party Name:||ENZO LIFE SCIENCES, INC., Appellant v. BECTON, DICKINSON AND COMPANY, Appellee UNITED STATES, Intervenor|
|Attorney:||Justin P.D. Wilcox, Desmarais LLP, New York, NY, argued for appellant. Also represented by Kerri-Ann Limbeek, Kevin Kent McNish. Thomas Saunders, Wilmer Cutler Pickering Hale and Dorr LLP, Washington, DC, argued for appellee. Also represented by William G. McElwain, Heather M. Petruzzi Nancy Schr...|
|Judge Panel:||Before Lourie, O'Malley, and Chen, Circuit Judges.|
|Case Date:||August 16, 2019|
|Court:||United States Courts of Appeals, Court of Appeals for the Federal Circuit|
This disposition is nonprecedential.
Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2016-00820, IPR2016-00822.
Justin P.D. Wilcox, Desmarais LLP, New York, NY, argued for appellant. Also represented by Kerri-Ann Limbeek, Kevin Kent McNish.
Thomas Saunders, Wilmer Cutler Pickering Hale and Dorr LLP, Washington, DC, argued for appellee. Also represented by William G. McElwain, Heather M. Petruzzi Nancy Schroeder, Los Angeles, CA; Omar Khan, New York, NY.
Dennis Fan, Appellate Staff, Civil Division, United States Department of Justice, Washington, DC, argued for intervenor. Also represented by Katherine Twomey Allen, Scott R. McIntosh, Joseph H. Hunt; Thomas W. Krause, Joseph Matal, Farheena Yasmeen Rasheed, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA.
Before Lourie, O'Malley, and Chen, Circuit Judges.
Lourie, Circuit Judge.
Enzo Life Sciences, Inc. appeals from two final written decisions of the United States Patent and Trademark Office ("PTO") Patent Trial and Appeal Board ("the Board") holding various claims of U.S. Patent 7, 064, 197 ("the '197 patent") unpatentable as anticipated or obvious. See Ho-logic, Inc. v. Enzo Life Scis., Inc., No. IPR2016-00820, 2017 WL 4339646 (P.T.A.B. Sept. 28, 2017) ("'820 Decision"); Ho-logic, Inc. v. Enzo Life Scis., Inc., No. IPR2016-00822, 2017 WL 4407743 (P.T.A.B. Oct. 2, 2017) ("'822 Decision"). The PTO intervened to defend the constitutionality challenge to inter partes review ("IPR") proceedings as applied to patents issued before the enactment of the America Invents Act ("AIA"), Pub. L. No. 112-29, 125 Stat. 284 (2011). For the following reasons, we affirm.
Deoxyribonucleic acid ("DNA") and ribonucleic acid ("RNA") are nucleic acids made of a series of nucleotides. A nucleotide is composed of a sugar, a phosphate, and a nitrogenous base. DNA has four nitrogenous bases: ade-nine (A), guanine (G), cytosine (C), and thymine (T). RNA also has the bases adenine (A), guanine (G), and cyto-sine (C), but contains uracil (U) instead of thymine (T). A polynucleotide refers to multiple nucleotides linked together in a chain. Two strands of polynucleotides can bind to one another, i.e., hybridize, through hydrogen bonding between complementary nucleotides known as Watson-Crick base pairing: bases T or U pair with A, and G pairs with C. A strand of nucleotides that is not hybridized to another strand is said to be single-stranded, while two strands hybridized to each other are said to be double-stranded.
Enzo owns the '197 patent directed to "the detection of genetic material by polynucleotide probes." '197 patent col. 1 ll. 23-24. The invention leverages hybridization techniques to detect the presence of an analyte, which may be "a DNA or RNA molecule," "a molecular complex," or "a biological system containing nucleic acids, such as a virus, a cell, or group of cells." Id. col. 1 ll. 39-42. A polynucleo-tide probe that is complementary to a target analyte will hybridize with it and is thereby used to detect that ana-lyte's presence. See id. col. 2 ll. 37-63. According to the invention, the analytes to be detected are "fixed . . . in hy-bridizable form to [a] non-porous solid support." Id. col. 13 ll. 63-67; see also id. col. 5 ll. 58-60. The specification also discloses that a "technique for improving the fixing or uniformity of the plastic surface for fixing DNA involves treatment of the surface with polylysine." Id. col. 11 ll. 37-39.
Independent claim 1 is representative of the claims challenged in IPR2016-00820 ("the '820 IPR") and independent claim 17 is representative of the claims challenged in IPR2016-00822 ("the '822 IPR"): 1. A non-porous solid support comprising one or more amine(s), hydroxyl(s) or epoxide(s) thereon, wherein at least one single-stranded nucleic acid is fixed or immobilized in hybridizable form to said non-porous solid support via said one or more amine(s), hydroxyl(s) or epoxide(s).
Id. col. 13 ll. 63-67 (emphases added).
17. An array comprising various single-stranded nucleic acids fixed or immobilized in hybridizable form to a non-porous solid support.
Id. col. 15 ll. 51-53 (emphases added).
Hologic, Inc. filed two petitions for IPR of the '197 patent. During both proceedings, Becton, Dickinson, & Company ("Becton") moved to join as a co-petitioner, and the Board granted the motions. See Joinder Order at 2, Ho-logic, Inc. v. Enzo Life Scis., Inc., No. IPR2016-00820 (P.T.A.B. Mar. 27, 2017), Paper No. 32; Joinder Order at 2, Hologic, Inc. v. Enzo Life Scis., Inc., No. IPR2016-00822 (P.T.A.B. Apr. 5, 2017), Paper No. 31. The Board instituted trial on all eight grounds of unpatentability across the two IPRs, which all rely on Fish1 or VPK2 as the primary reference.
The Board determined that all the challenged claims were unpatentable as anticipated by Fish or rendered obvious by Fish alone or in combination with other prior art references. '820 Decision, 2017 WL 4339646, at *11-15; '822 Decision, 2017 WL 4407743, at *10-15. The Board next determined that VPK qualified as a prior art reference. '820 Decision, 2017 WL 4339646, at *15-18; '822 Decision, 2017 WL 4407743, at *15-18. The Board found that the '197 patent could not claim priority from its original parent application's filing date of January 27, 1983, because that application did not provide written description support for the claimed "non-porous solid support." See, e.g., '197 patent col. 13 l. 63. Instead, the Board determined that the '197 patent could only claim priority from the 1983 application's child continuation-in-part application, which was filed on May 9, 1985. VPK was publicly available as of October 1982, more than a year before the critical date of May 9, 1985, and thus qualified as prior art. See 35 U.S.C. § 102(b) (2006). The Board then concluded that all the challenged claims were anticipated by VPK or would have been obvious over VPK in combination with other prior art references. '820...
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