throbber
Trials@uspto.gov
`571-272-7822
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` Paper 9
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`Date: March 23, 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 IPR2017-00172
`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
`
`
`
`
`

`

`IPR2017-00172
`Patent 7,064,197 B1
`
`I.
`
`INTRODUCTION
`
`Becton, Dickinson, and Company, (“Petitioner” or “Becton”) filed a
`Petition to institute an inter partes review of claims 1, 6, 8, 9, 12–16, 27,
`31–34, 38, 41, 61–64, 68–70, 72–74, 78, 79, 100, 101, 191–195, 212, 213,
`218, 219, 222, 225–227, 230, 233, and 236 of U.S. Patent No. 7,064,197 B1
`(Ex. 1001, “the ’197 patent”) pursuant to 35 U.S.C. § 311(a). Paper 2
`(“Pet.”). Petitioner also filed a Motion for Joinder (“Motion”) with Hologic
`Inc. v. Enzo Life Sciences, Inc., IPR2016-00820 (the “Hologic IPR”).
`Paper 3 (“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 has filed an additional petition to institute an inter partes
`review of the ’197 patent in which it challenges other claims of the patent.
`See IPR2017-00181. Also, 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
`
`

`

`IPR2017-00172
`Patent 7,064,197 B1
`
`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
`
`

`

`IPR2017-00172
`Patent 7,064,197 B1
`
`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 1, 6, 8, 9, 12–16, 27, 31–34, 38, 41, 61–
`64, 68–70, 72–74, 78, 79, 100, 101, 191–195, 212, 213, 218, 219, 222, 225–
`227, 230, 233, and 236. Pet. 1. Of the challenged claims, claims 1, 6, 8, 9,
`12–15, and 27 are independent. The remainder of the challenged claims all
`depend directly from at least one of the challenged independent claims, with
`several of them in multiple dependent form.
`
`Claim 1 is illustrative and reproduced below.
`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).
`
`4
`
`

`

`IPR2017-00172
`Patent 7,064,197 B1
`
`D. Asserted Grounds of Unpatentability
`
`Petitioner asserts the following grounds of unpatentability:
`Basis1
`References
`Claims Challenged
`Fish (Ex. 1006)2
`§ 102(b)
`1, 6, 8, 9, 12–16, 27, 32–34, 41,
`61–63, 69, 70, 72–74, 79, 100,
`191, 193, 194, 212, 213, 219,
`222, 225–227, 230, 233, and 236
`31, 64, 68, 101, 192, and 195
`38, 78, and 218
`
`§ 103(a)
`§ 103(a)
`
`Fish
`Fish and Gilham
`(Ex. 1019)3
`VPK (Ex. 1008)4 § 102(a)
`and (b)
`
`1, 6, 8, 9, 12–15, 27, 31, 32, 34,
`61–63, 68–70, 72, 74, 79, 100,
`191–193, 194, 213, 219, 226,
`227, and 236
`33, 41, 73, 212, 225, and 233
`
`VPK and Metzgar
`(Ex. 1009)5
`
`§ 103(a)
`
`
`1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29,
`which was enacted September 16, 2011, made amendments to 35 U.S.C.
`§§ 102 and 103. AIA § 3(b)–(c). Those amendments became effective
`eighteen months later on March 16, 2013. Id. at § 3(n). Because the
`application from which the ’197 patent issued was filed before March 16,
`2013, our citations to 35 U.S.C. §§ 102 and 103 are to their pre-AIA
`versions.
`2 Falk Fish, et al., “A Sensitive Solid Phase Microradioimmunoassay For
`Anti-Double Stranded DNA Antibodies,” Arthritis and Rheumatism,
`Vol. 24, No. 3, 534–43 (March 1981).
`3 P. T. Gilham, “Immobilized Polynucleotides and Nucleic Acids,”
`Immobilized Biochemicals and Affinity Chromatography, 173–85 (1974).
`
`4 A. C. Van Prooijen-Knegt, et al. “In Situ Hybridization of DNA Sequences
`in Human Metaphase Chromosomes Visualized by an Indirect Fluorescent
`Immunocytochemical Procedure,” Experimental Cell Research, Vol. 141,
`397–407 (Oct. 1982).
`
`5
`
`

`

`IPR2017-00172
`Patent 7,064,197 B1
`
`Pet. 5 n.2, 7–8.6 These grounds are the same as those on which trial was
`instituted in the Hologic IPR. Pet. 5 n.2 (“Petitioner is only requesting
`institution of the Grounds already instituted in the Hologic IPR.”); IPR2016-
`00820, Paper 10.
`
`Becton’s claim construction and unpatentability arguments for these
`grounds are the same as those presented by Hologic in the Hologic IPR.
`Compare Pet. 13–59, with IPR2016-00820, Paper 1, 12–66; see also Mot. 1
`(“Petitioner’s IPR . . . is identical to the Hologic 820 IPR in all substantive
`respects: Petitioner’s IPR asserts the same grounds on the same claims as
`those in the Hologic 820 IPR and includes identical exhibits to those in the
`Hologic 820 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 IPR2016-00820, Ex. 1002.
`
`
`
`
`5 U.S. Patent No. 3,572,892, issued Mar. 30, 1971.
`6 On pages 7 to 8 and 33 of the Petition, Petitioner asserts that claims 31, 68,
`and 192 are also anticipated by Fish. Hologic did the same in its petition. In
`the Hologic IPR, we denied institution on those three claims as anticipated
`by Fish, although we instituted on those claims on other grounds. It seems
`that Becton did not intend to challenge these three claims as anticipated by
`Fish in light of its multiple statements stressing the identity of its challenges
`with those instituted in the Hologic IPR. See Pet. 5 n. 2, (Becton “is only
`requesting institution of the Grounds already instituted in the Hologic
`IPR.”); Mot. 7 (“Petitioner’s IPR proposes institution of trial on the same
`grounds as those instituted by the Board in the Hologic 820 IPR.”), 9
`(“Petitioner does not raise any issues that are not already before the Board
`[in the Hologic IPR].”).
`
`6
`
`

`

`IPR2017-00172
`Patent 7,064,197 B1
`
`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 (“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
`
`

`

`IPR2017-00172
`Patent 7,064,197 B1
`
`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. at 7–8. Becton “is willing to adhere to the
`schedule already established for the Hologic 820 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. 1.7
`Accordingly, we exercise our discretion to join Becton as a party to the
`Hologic IPR. Accordingly, the Motion is granted-in-part.8
`
`
`7 Patent Owner “conditionally” opposed joinder if either: (1) IPR2016-
`00820 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.
`8 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
`
`

`

`IPR2017-00172
`Patent 7,064,197 B1
`
`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).9
`
`The identical art and unpatentability arguments have been raised in
`
`
`9 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).
`
`9
`
`

`

`IPR2017-00172
`Patent 7,064,197 B1
`
`the Hologic IPR, to which Becton is being joined.10 Granting the instant
`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.
`
`
`
`
`
`10 In its Preliminary Response here, Patent Owner presents “arguments Enzo
`[Patent Owner] did not include in its optional preliminary response in Case
`IPR2016-00820 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. 9–22 (regarding the limitation “hybridizable form”))
`or based on Patent Owner’s characterizations of Dr. Nelson’s testimony
`taken during cross-examination in the Hologic IPR to which neither Becton
`nor Hologic has yet to respond. See, e.g., id. at 4–8. 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).
`10
`
`

`

`IPR2017-00172
`Patent 7,064,197 B1
`
`It is
`
`IV. ORDER
`
`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 IPR2016-00820;11 and
`
`FURTHER ORDERED that the Petition is denied.
`
`
`11 An Order reflecting the same will be entered in IPR2016-00820.
`11
`
`

`

`IPR2017-00172
`Patent 7,064,197 B1
`
`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
`
`
`
`
`
`
`
`12
`
`

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