Trials@uspto.gov
`571-272-7822
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`Paper 9
`Date: April 5, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BECTON, DICKINSON AND COMPANY,
`Petitioner,
`
`v.
`
`ENZO LIFE SCIENCES, INC.,
`Patent Owner.
`
`
`
`Case IPR2017-00181
`Patent 7,064,197 B1
`
`
`
`
`Before MICHAEL J. FITZPATRICK, ZHENYU YANG, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`
`
`FITZPATRICK, Administrative Patent Judge.
`
`
`DECISION
`Granting Joinder; Denying Inter Partes Review
`37 C.F.R. §§ 42.108, 42.122
`
`
`
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`571-272-7822
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`Paper 9
`Date: April 5, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BECTON, DICKINSON AND COMPANY,
`Petitioner,
`
`v.
`
`ENZO LIFE SCIENCES, INC.,
`Patent Owner.
`
`
`
`Case IPR2017-00181
`Patent 7,064,197 B1
`
`
`
`
`Before MICHAEL J. FITZPATRICK, ZHENYU YANG, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`
`
`FITZPATRICK, Administrative Patent Judge.
`
`
`DECISION
`Granting Joinder; Denying Inter Partes Review
`37 C.F.R. §§ 42.108, 42.122
`
`
`
`
`
`
`IPR2017-00181
`Patent 7,064,197
`
`I.
`
`INTRODUCTION
`
`Becton, Dickinson and Company (“Petitioner” or “Becton”) filed a
`Petition to institute an inter partes review of claims 17, 19, 25, 105, 106,
`113, 114, 116, 119, 120, 128–131, 150–152, 154, 178, 180, 185–187, and
`189 of U.S. Patent No. 7,064,197 B1 (Ex. 1001, “the ’197 patent”) pursuant
`to 35 U.S.C. § 311(a). Paper 3 (“Pet.”). Petitioner also filed a Motion for
`Joinder (“Motion”) with Hologic Inc. v. Enzo Life Sciences, Inc., IPR2016-
`00822 (the “Hologic IPR”). Paper 2 (“Mot.”).
`
`Patent Owner, Enzo Life Sciences, Inc., filed a Preliminary Response
`pursuant to 35 U.S.C. § 313 (Paper 8, “Prelim. Resp.”) and a Response to
`Petitioner’s Motion for Joinder (Paper 7, “Joinder Resp.”).
`
`For reasons explained below, we grant joinder and deny the Petition.
`
`A. Related Matters
`Petitioner filed an additional petition to institute an inter partes review
`of the ’197 patent in which it challenged other claims of the patent. See
`IPR2017-00172. That petition was denied. However, two inter partes
`reviews of claims of the ’197 patent are pending. See IPR2016-00820;
`IPR2016-00822.
`
`The parties identify the following lawsuits as involving the ’197
`patent: Enzo Life Sciences, Inc. v. Hologic, Inc., No. 1:15-cv-271 (D. Del.);
`Enzo Life Sciences, Inc. v. Siemens Healthcare Diagnostics, Inc., No. 1:12-
`cv-505 (D. Del.); Enzo Life Sciences, Inc. v. Affymetrix, Inc., No. 1:12-cv-
`433 (D. Del.); Enzo Life Sciences, Inc. v. Agilent Technologies Inc., No.
`1:12-cv-434 (D. Del.); Enzo Life Sciences, Inc. v. Illumina Inc., No. 1:12-cv-
`
`2
`
`
`
`IPR2017-00181
`Patent 7,064,197
`
`435 (D. Del.); Enzo Life Sciences, Inc. v. Abbott Laboratories et al., No.
`1:12-cv-274 (D. Del.); Enzo Life Sciences, Inc. v. Becton Dickinson and
`Company et al., No. 1:12-cv-275 (D. Del.); Enzo Life Sciences, Inc. v. Life
`Technologies Corp., No. 1:12-cv-105 (D. Del.); and Enzo Life Sciences, Inc.
`v. Roche Molecular Systems Inc. et al., No. 1:12-cv-106 (D. Del.). Pet. 2–3;
`Paper 6, 1–2.
`
`B. The ’197 Patent
`
`The ’197 patent relates generally to the detection of genetic material
`by polynucleotide probes. Ex. 1001, 1:23–24. The ’197 patent refers to the
`material to be detected as an analyte. Id. at 1:37–39. An analyte may be
`present in a biological sample such as a clinical sample of blood, urine,
`saliva, etc. Id. at 5:47–50. If an analyte of interest is present in a biological
`sample, it is fixed, according to the invention of the ’197 patent, in
`hybridizable form to a solid support. Id. at 5:58–60. The ’197 patent states
`that it is preferred, and all of the challenged claims require, that the solid
`support be non-porous. Id. at 6:2–6; e.g., id. at 15:51–53 (claim 17 reciting
`a “non-porous solid support”).
`Chemically-labeled probes are then brought into
`contact with the fixed single-stranded analytes
`under hybridizing conditions. The probe
`is
`characterized by having covalently attached to it a
`chemical label which consists of a signalling moiety
`capable of generating a soluble signal. Desirably,
`the polynucleotide or oligonucleotide probe
`provides sufficient number of nucleotides in its
`sequence, e.g., at least about 25, to allow stable
`hybridization with the complementary nucleotides
`of the analyte. The hybridization of the probe to the
`single-stranded analyte with the resulting formation
`3
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`IPR2017-00181
`Patent 7,064,197
`
`of a double-stranded or duplex hybrid is then
`detectable by means of the signalling moiety of the
`chemical label which is attached to the probe
`portion of the resulting hybrid. Generation of the
`soluble signal provides simple and rapid visual
`detection of the presence of the analyte and also
`provides a quantifiable report of the relative amount
`of
`analyte
`present,
`as measured
`by
`a
`spectrophotometer or the like.
`Id. at 6:15–32.
`
`C. The Challenged Claims
`
`Petitioner challenges claims 17, 19, 25, 105, 106, 113, 114, 116, 119,
`120, 128–131, 150–152, 154, 178, 180, 185–187, and 189. Pet. 1. Of the
`challenged claims, claims 17, 19, and 25 are independent. They are
`illustrative and reproduced below.
`17. An array comprising various single-stranded
`nucleic acids fixed or immobilized in hybridizable form to a
`non-porous solid support.
`19. An array comprising single-stranded nucleic acids
`fixed or immobilized in hybridizable form to a non-porous solid
`support.
`25. An array comprising various single-stranded
`nucleic acids fixed or immobilized in hybridizable form to a
`non-porous solid support having wells or depressions.
`
`4
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`
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`IPR2017-00181
`Patent 7,064,197
`
`D. Asserted Grounds of Unpatentability
`
`Petitioner asserts the following grounds of unpatentability:
`Basis1
`References
`Claims Challenged
`Fish (Ex. 1006)2
`§ 102(b) 17, 19, 25, 105, 106, 114,
`116, 119, 128, 129, 150,
`152, 178, 180, 186, and 187
`§ 103(a) 130, 131, 151, and 154
`§ 103(a) 120 and 189
`
`Fish
`Fish, Metzgar (Ex. 1009),3
`and Sato (Ex. 1034)4
`Fish and Gilham
`(Ex. 1019)5
`VPK (Ex. 1008)6 and
`Metzgar
`
`§ 103(a) 113 and 185
`
`§ 103(a) 17, 19, 25, 105, 106, 114,
`119, 120, 128, 129, 131,
`150–152, 178, 180, 186,
`and 189
`
`
`1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284 (September 16, 2011), took effect on March 18, 2013. Because the
`application from which the ’197 patent issued was filed before that date, our
`citations to 35 U.S.C. §§ 102 and 103 are to their pre-AIA version.
`2 Falk Fish & Morris Ziff, “A Sensitive Solid Phase
`Microradioimmunoassay For Anti-Double Stranded DNA Antibodies,”
`24(3) Arthritis and Rheumatism 534–43 (March 1981).
`3 U.S. Patent No. 3,572,892, issued to Don P. Metzgar and James V.
`Sorrentino on Mar. 30, 1971.
`4 Sato et al., “Cell Surface Charge and Cell Division in Escherichia coli
`after X irradiation,” 87 Radiation Research 646–56 (1981).
`5 P. T. Gilham, “Immobilized Polynucleotides and Nucleic Acids,”
`Immobilized Biochemicals and Affinity Chromatography 173–85 (R. Bruce
`Dunlap, ed., Plenum Press 1974).
`
`6 A. C. Van Prooijen-Knegt, et al. “In Situ Hybridization of DNA Sequences
`in Human Metaphase Chromosomes Visualized by an Indirect Fluorescent
`Immunocytochemical Procedure,” 141(2) Experimental Cell Research 397–
`
`5
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`IPR2017-00181
`Patent 7,064,197
`
`Basis1
`Claims Challenged
`§ 103(a) 113, 116, 130, 154, 185,
`and 187
`
`References
`Noyes (Ex. 1007),7 VPK,
`Metzgar, and
`Ramachandran (Ex. 1028)8
`Pet. 7, 16–31.9 These grounds are the same as those on which trial was
`instituted in the Hologic IPR. See Mot. 1 (Becton “asserts the same grounds
`on the same claims as those in the Hologic 822 IPR”); Id. at 9 (Becton “does
`not raise any issues that are not already before the Board [in the Hologic
`IPR].”); IPR2016-00822, Paper 8.
`
`Becton’s claim construction and unpatentability arguments for these
`grounds are the same as those presented by Hologic in the Hologic IPR.
`Compare Pet. 12–58, with IPR2016-00822, Paper 3, 11–57; see also Mot. 1
`(Becton’s Petition “is identical to the Hologic 822 IPR in all substantive
`respects: [it] asserts the same grounds on the same claims as those in the
`Hologic 822 IPR and includes identical exhibits to those in the Hologic 822
`IPR.”). Becton relies on the same declarant, Norman Nelson, Ph.D., and
`even the same declaration testimony, as Hologic. Mot. 7; compare
`Ex. 1002, with IPR2016-00822, Ex. 1002.
`
`
`407 (Oct. 1982).
`7 Barbara E. Noyes & George R. Stark, “Nucleic Acid Hybridization Using
`DNA Covalently Coupled to Cellulose,” 5 Cell 301–10 (July 1975).
`8 K. B. Ramachandran & D. D. Perlmutter, “Effects of Immobilization on
`the Kinetics of Enzyme-Catalyzed Reactions. I. Glucose Oxidase in a
`Recirculation Reactor System,” XVIII Biotechnology and Bioengineering
`669–84 (1976).
`9 In a chart, Petitioner lists claim 131 as also being challenged as anticipated
`by Fish. Pet. 7. In its analysis, however, it does not address claim 131 as
`being anticipated by Fish. See Pet. 16–31.
`6
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`IPR2017-00181
`Patent 7,064,197
`
`II.
`
`JOINDER
`
`Becton’s Motion is timely because it was filed on November 3, 2016,
`within one month of our October 4, 2016, institution of the Hologic IPR.
`See 37 C.F.R. § 42.122(b) (“Any request for joinder must be filed, as a
`motion under § 42.22, no later than one month after the institution date of
`any inter partes review for which joinder is requested.”).
`
`The Motion, on its face, seeks joinder of Becton’s “petition” and its
`“IPR” with the pending Hologic IPR. Mot. 1. The statutory sub-section
`under which Becton seeks relief, 35 U.S.C. § 315(c), does not refer to
`joining a petition or inter partes review to another inter partes review. Id.;
`but cf. id. § 315(d) (referring to “consolidation” of a pending inter partes
`review and “another proceeding or matter involving the patent”). Section
`315(c) refers to joining, rather, a “person” “as a party” to an instituted inter
`partes review. It states the following:
`
`(c) JOINDER.—If the Director institutes an inter partes review,
`the Director, in his or her discretion, may join as a party to that
`inter partes review any person who properly files a petition under
`section 311 that the Director, after receiving a preliminary
`response under section 313 or the expiration of the time for filing
`such a response, determines warrants the institution of an inter
`partes review under section 314.
`35 U.S.C. § 315(c) (emphasis added). Hence, we consider Becton’s Motion
`as seeking joinder under 35 U.S.C. § 315(c) of Becton as a party to the
`Hologic IPR and consolidation under 35 U.S.C. § 315(d) of its petitioned-for
`inter partes review with the Hologic IPR.
`
`There is no right to joinder. It is relief that we grant or deny in our
`discretion. 35 U.S.C. § 315(c). The statute, however, does require that the
`7
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`IPR2017-00181
`Patent 7,064,197
`
`person to be joined must properly file a petition that warrants the institution
`of an inter partes review under 35 U.S.C. § 314. 35 U.S.C. § 315(c).
`Becton has done this; we have already determined that identical challenges
`to the same claims warranted institution in the Hologic IPR. Accordingly, in
`our discretion, we may grant joinder of Becton as a party to the Hologic IPR.
`
`Becton represents that, so long as Hologic remains a party in the
`Hologic IPR, Hologic “will maintain the lead role” and Becton “agrees not
`to advance any arguments separate from those advanced by Hologic.”
`Mot. 7. Likewise, so long as Hologic remains a party in the Hologic IPR,
`Becton will allow Hologic’s counsel alone to conduct any cross-examination
`or redirect of any witness. Id. Becton “is willing to adhere to the schedule
`already established for the Hologic 822 IPR.” Id. at 9.
`
`Under these circumstances, it is likely that joining Becton as a party to
`the Hologic IPR will not unduly delay or detrimentally affect the Hologic
`IPR. Also, Patent Owner does not oppose joinder. Joinder Resp. 1.10
`Accordingly, we exercise our discretion to join Becton as a party to the
`Hologic IPR; the Motion is granted-in-part.11
`
`
`10 Patent Owner “conditionally” opposed joinder if either: (1) IPR2016-
`00822 were terminated pursuant to Patent Owner’s request for rehearing of
`the institution decision; or (2) we were to determine the instant Petition does
`not warrant institution. Joinder Resp. 1. Neither condition exists.
`11 The Motion is dismissed-in-part as moot to the extent Becton seeks
`consolidation under 35 U.S.C. § 315(d). As explained below, we are not
`granting the instant Petition. Thus, there will be no additional inter partes
`review that could be consolidated with the Hologic IPR.
`8
`
`
`
`IPR2017-00181
`Patent 7,064,197
`
`III. BECTON’S PETITION
`
`As discussed above, Becton’s Petition presents the same grounds
`against the same claims on which we instituted the Hologic IPR, and it does
`so by making the same arguments and presenting the same evidence.
`Consistent with our October 4, 2016, decision to institute in the Hologic
`IPR, there is a reasonable likelihood that Becton would prevail with respect
`to at least 1 of the claims challenged in its Petition. Hence, the Petition
`warrants institution of an inter partes review under 35 U.S.C. § 314.
`
`However, there is no right to an inter partes review. See 35 U.S.C.
`§ 314 (governing institution of inter partes reviews but not mandating
`institution under any circumstances). Also, in determining whether to
`institute an inter partes review, we “may take into account whether, and
`reject the petition . . . because, the same or substantially the same prior art or
`arguments previously were presented to the Office.” 35 U.S.C. § 325(d).12
`
`The identical art and unpatentability arguments have been raised in
`the Hologic IPR, to which Becton is being joined.13 Granting the instant
`
`
`12 Although § 325(d) refers only to determinations by “the Director,” the
`Director has delegated institution authority to the Board. See 37 C.F.R.
`§ 42.4(a).
`13 In its Preliminary Response here, Patent Owner presents “arguments [it]
`did not include in its optional preliminary response in Case IPR2016-00822
`in order to show that the Petition does not establish a reasonable likelihood
`of prevailing as to any claim, and thus does not warrant institution.” Joinder
`Resp. 1. The additional arguments, however, largely are repeats of Patent
`Owner’s prior claim construction arguments (see, e.g., Prelim. Resp. 8–20
`(regarding the limitation “hybridizable form”)) or based on Patent Owner’s
`characterizations of Dr. Nelson’s testimony taken during cross-examination
`
`9
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`IPR2017-00181
`Patent 7,064,197
`
`Petition and conducting a separate proceeding would be a waste of time and
`resources for all involved. Granting the instant Petition and consolidating
`the resulting proceeding with the Hologic IPR would complicate the latter
`proceeding with a second set of papers that would be duplicative in
`substance of the papers already of record in the latter proceeding.
`
`Accordingly, in light of Becton joining as a party to the Hologic IPR
`and to effect more efficient administration of the patentability challenges, we
`deny the Petition.
`
`IV. ORDER
`
`It is
`
`ORDERED that the Motion for Joinder is granted-in-part and
`dismissed-in-part as moot;
`
`FURTHER ORDERED that Becton, Dickinson and Company is
`joined as a party, on the petitioner side, to IPR2016-00822;14 and
`
`FURTHER ORDERED that the Petition is denied.
`
`
`in the Hologic IPR to which neither Becton nor Hologic has yet to respond.
`See, e.g., id. at 4–7. The additional arguments do not alter our determination
`that there is a reasonable likelihood that Becton would prevail with respect
`to at least 1 of the claims challenged in the petition. See 35 U.S.C. § 314(a).
`14 An Order reflecting the same will be entered in IPR2016-00822.
`10
`
`
`
`IPR2017-00181
`Patent 7,064,197
`
`For Petitioner:
`Jamie T. Wisz
`Heather Petruzzi
`WILMER CUTLER PICKERING HALE AND DORR LLP
`Jamie.Wisz@WilmerHale.com
`Heather.Petruzzi@WilmerHale.com
`
`
`
`For Patent Owner:
`
`Kevin K. McNish
`DESMARAIS LLP
`kmcnish@desmaraisllp.com
`
`
`11
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