Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 1 of 21 PageID #: 44748
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE.
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`ENZO LIFE SCIENCES, INC.,
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`Plaintiff.
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`v.
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`ABBOTT LABORATORIES and
`ABBOTT MOLECULAR, INC.,
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`Defendants.
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`C.A. No. 12-274-LPS
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`Brian E. Farnan, FARNAN LLP, Wilmington, DE
`John M. Desmarais, Michael P. Stadnick, Justin P.D. Wilcox, Jordan Malz, Peter C. Magic,
`DESMARAIS LLP, New York, NY
`
`Attorneys for Plaintiff Enzo Life Sciences, Inc.
`
`John C. Phillips, David A. Bilson, PHILLIPS, GOLDMAN, MCLAUGHLIN & HALL LLP,
`Wilmington, DE
`·
`James F. Hurst, Amanda Hollis, KIRKLAND & ELLIS LLP, Chicago, IL
`Benjamin A. Lasky, Stefan M. Miller, KIRKLAND & ELLIS LLP, New York, NY
`Michael A. Pearson, Ji;., Jason M. Wilcox, KIRKLAND & ELLIS LLP, Washington, DC·
`
`Attorneys for Defendants Abbott Laboratories and Abbott Molecular, Inc.
`
`MEMORANDUM OPINION
`
`August 15, 2017
`Wilmington, Delaware
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`

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`Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 2 of 21 PageID #: 44749
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`.
`p ~,~r(J
`ST~U.S. District Jn~
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`Pending before the Court are: (i) Defendants Abbott Laboratories and Abbott Molecular
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`Inc.'s (collectively, "Abbott" or "Defendants") Motion for Summary Judgment of Invalidity of
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`U.S. Patent No. 8,097,405 (the "'405 patent") for Failure to Comply with the Written Description
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`Requirement (D.I. 413 at 6-16), and (ii) Abbott's Motion for Summary Judgment of Invalidity of
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`the '405 Patent for Nonenablement (D.I. 458). For the reasons set forth below, the Court will
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`deny Abbott's motion with respect to written description and will grant Abbott's motion with
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`respect to nonenablement.
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`I.
`
`BACKGROUND
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`PlaintiffEnzo Life Sciences, Inc. ("Enzo" or "Plaintiff') filed this patent infringement
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`action against Abbott, alleging infringement of the '405 patent as well as U.S. Patent No.
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`6,992, 1 $0 ("the '180 patent").
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`The '405 patent, which is the subject of the pending motions, generally pertains to non-
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`radioactive labeling and "relate[s] to nucleic acid[ 1
`] detection technology that relies upon the
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`ability of nucleic acid (DNA or RNA) strands to hybridize - or bind together." (D.I. 430 at 7)
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`(internal quotation marks omitted) While "the prevailing perception in the art [at the time of the
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`invention] was that specific base moieties (the so-called 'Ward' positions) were the only possible
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`positions for labeling," the '405 patent discloses that nucleotides "with non-radioactive labels
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`attached to certain positions of a nucleotide - the phosphate moiety, sugar moiety, or non-Ward
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`positions on the base moiety- could ... be used as detectable nucleic acid probes." (D.I. 423 at
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`1"Nucleic acids (DNA or_RNA) are made up of 'nucleotide[s],' each of which 'typically
`consists of three parts: a base, a sugar, and a phosphate."' (D.I. 430 at 7) (quoting D.I. 431-2 Ex.
`16 at 9)
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`1
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`Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 3 of 21 PageID #: 44750
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`5-6 (emphasis omitted); see also D.l. 427 at A2130)
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`The '405 patent was issued on January 17, 2012 and claims priority to June 23, 1982.
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`· (See D.I. 423 at 6) The asserted claims of the '405 patent "fall into two categories: the in situ
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`hybridization claims and the liquid phase claims." (D.I. 430 at 8) The in situ hybridization
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`claims -claims 63, 64, 65, 94, 103, 128, and 144 - "recite processes for counting or identifying
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`chromosomes through 'specific hybridization' to a 'locus or loci' of a chromosome, using probes
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`labeled at specified positions." (Id.) The liquid phase claims - claims 196 and 198 - "specify
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`permissible Sigs [detectable labels] and detection methods, respectively. "2 (Id. at 9)
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`Abbott moved for summary judgment of invalidity of the '405 patent for lack of written
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`. description on May 12, 2017 (D.I.410 at 6-16; D.I. 413 at 6-16),3 and the parties completed
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`briefing on July 7, 2017 (D.l. 413, 423, 448). On June 28, 2017, while summary judgment
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`briefing was underway, the Court issued a Memorandum Opinion in a related case, Enzo Life
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`Sciences, Inc. v. Gen-Probe Inc., C.A. No. 12-104-LPS, granting a defense motion for summary
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`2Claims 94, 103, 128, and 144 depend from independent claims 63, 64, and 65, among
`other claims. Claims 196 and 198 depend from independent claims 188 and 189, both of which
`recite the following limitations that are pertinent here:
`
`A process for detecting the presence of a nucleic acid of interest in a sample,
`·comprising: providing or generating (i) a detectable non-radioactively labeled
`oligonucleotide or polynucleotide, ... and (ii) a sample that may contain said
`nucleic acid of interest; forming in liquid phase, hybrids comprising said
`detectable non-radioactively labeled oligonucleotide or polynucleotide specifically
`hybridized with said nucleic acid of interest; and detecting hybrids
`non-radioactively to detect the presence of said nucleic acid of interest.
`
`('405 patent col. 5411. 31.-67, col. 5511. 1-10)
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`3D.I. 413 is an amendment to Abbott's opening brief, D.I. 410, and was filed on May 12, ·
`2017. When citing to Abbott's opening brief, this Memorandum Opinion refers to D.I. 413, not
`D.I. 410.
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`2
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`

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`Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 4 of 21 PageID #: 44751
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`judgment that the asserted claims of the '180 patent are invalid for nonenablement. (C.A. No.
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`12-104-LPS D.I. 284) ("Gen-Probe Opinion" or "GP Op.") On the same day, the Court issued an
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`oral order in the instant case, requiring the parties to submit a joint status report discussing their
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`respective position( s) on how the Court should proceed with respect to the summary judgment
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`motions pending here. (D .I. 441)
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`In their July 10 status report, the parties agreed that the Gen-Probe Opinion invalidated all
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`· of the '180 patent claims asserted against Abbott and that all pending motions pertaining to the
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`'180 patent were now moot. (See D.I. 450 at 4-5) The status report also included Abbott's
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`request for leave to file a motion for summary judgment of invalidity of the '405 patent for
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`nonenablement. (See id. at 6) In Abbott's view, good cause was established by the Gen-Probe
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`Opinion, because "the '405 patent is related to and has essentially the same specification as the
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`'180 patent." (Id. at 5)
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`The Court granted Abbott's request for leave. (D.I. 451) Thereafter, between July 18 and
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`August 1, 2017, the parties submitted additional letter briefing with respect to enablement. (D.I.
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`459, 461, 462) The Court heard oral argument on August 8, 2017. (See Transcript ("Tr."))
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`II.
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`LEGAL STANDARDS
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`A.
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`Summary Judgment
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`Under Rule 56(a) of the Federal Rules of Civil Procedure, "[t]he court shall grant
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`summary judgment if the movant shows that there is no genuine dispute as to any material fact
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`and the movant is entitled to judgment as a matter oflaw." The moving party bears the burden of
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`demonstrating the absence of a genuine issue of material fact. See Matsushita Elec. Indus. Co.,
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`Ltd. v. Zenith Radio Corp., 475 U.S. 574, 585-86 (1986). An assertion that a fact cannot be - or,
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`3
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`alternatively, is - genuinely disputed must be supported either by "citing to particular parts of
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`materials in the record, including depositions, documents, electronically stored information,
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`affidavits or declarations, stipulations (including those made for purposes of the motion only),
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`admissions, interrogatory answers, or other materials," or by "showing that the materials cited do
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`not establish the absence or presence of a genuine dispute, or that an adverse party cannot
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`produce admissible evidence to support the fact." Fed. R. Civ. P. 56(c)(l)(A) & (B). If the
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`moving party has carried its burden, the nonmovant must then "come forward with specific facts
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`showing that there is a genuine issue for trial." Matsushita, 475 U.S. at 587 (internal quotation
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`marks omitted). The Court will "draw all reasonable inferences in favor of the nonmoving party,
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`and it may not make credibility determinations or weigh the evidence." Reeves v. Sanderson
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`Plumbing Prods., Inc., 530 U.S. 133, 150 (2000).
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`To defeat a motion for summary judgment, the nonmoving party must "do more than
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`simply show that there is some metaphysical doubt as to the material facts." Matsushita, 475
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`U.S. at 586; see also Podobnik v. U.S. Postal Serv., 409 F.3d 584, 594 (3d Cir. 2005) (stating
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`party opposing summary judgment "must present more than just bare assertions, conclusory
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`allegations or suspicions to show the existence of a genuine issue") (internal quotation marks
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`omitte,d). The "mere existence of some alleged factual dispute between the parties will not defeat
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`an otherwise properly supported motion for summary judgment;" a factual dispute is genuine
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`only where "the evidence is such that a reasonable jury could return a verdict for the nonmoving
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`party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986). "If the evidence is merely
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`colorable, or is not significantly probative, summary judgment may be granted." Id. at 249-50 ·
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`(internal citations omitted); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986) (stating
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`4
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`· entry of summary judgment is mandated "against a party who fails to make a showing sufficient
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`to establish the existence of an element essential to that party's case, and on which that party will
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`bear the burden of proof at trial"). Thus, the "mere existence of a scintilla of evidence" in
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`support of the nonmoving party's position is insufficient to defeat a motion for summary
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`judgment; there must be "evidence on which the jury could reasonably find" for the nonmoving
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`party. Anderson, 477 U.S. at 252.
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`B.
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`Patent Validity Under 35 U.S.C. § 112
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`Paragraph 1 of 35 U.S.C. § 1124 states in pertinent part:
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`The specification shall contain a written description of the
`invention and of the manner and process of making and using it, in
`such full, clear, concise and exact terms as to enable any person
`skilled in the art to which it pertains, or with which it is most
`nearly connected, to make and use the same ....
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`The statute sets out separate req~irements for written description and enablement. See
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`Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1344 (Fed. Cir. 2010) (holding that written
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`· description and enablement requirements are separate). Nonetheless, these requirements "often
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`rise and fall together." Id. at 1352.
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`1.
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`Written Description
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`Whether a specification satisfies the written description requirement is a question of fact.
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`See GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., 744 F.3d 725, 729 (Fed. Cir. 2014); see
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`also Alcon, Inc. v. Teva Pharms. USA, Inc., 664 F. Supp. 2d 443, 468 (D. Del. 2009)
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`4The patent statute was amended in September 2011 by the America !µvents Act ("AIA").
`See Leahy-Smith America Invents Act, Pub.L. No. 112-29, 125 Stat. 284, 300-01 (2011). The
`pre-AIA version of§ 112 applies in this case. The post-AIA version of this portion of the statute
`(§ 112(a)) is identical to the pre-AIA verison.
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`5
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`. ("Satisfaction of the written description requirement is a fact-based inquiry, depending on 'the
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`nature of the claimed invention and the knowledge of one skilled in the art at the time an
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`invention is made and a patent application is filed.'") (quoting Carnegie Mellon Univ. v.
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`Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008)). Despite being a question of
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`fact, the issue of invalidity for lack of written description can be amenable to summary judgment.
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`See, e.g., Carnegie Mellon, 541 F.3d at 1126-28 (affirming summary judgment of invalidity for
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`lack of written description); see also Helicos Biosciences Corp. v. lllumina, Inc., 888 F. Supp. 2d
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`519, 530-31 (D. Del. 2012) ("While compliance with the written description requirement is a
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`question of fact, the issue is 'amenable to summary judgment in cases where no reasonable fact
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`finder could return a verdict for the non-moving party."') (quoting PowerOasis, Inc. v. T-Mobile
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`USA, Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008)).
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`To comply with the written description requirement, a patent's specification "must clearly
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`allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed."
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`Ariad, 598 F.3d at 1351 (internal brackets and quotation marks omitted); "[T]he test for
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`sufficiency is whether the disclosure of the application relied upon reasonably conveys to those
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`skilled in the art that the inventor had possession of the claimed subject matter as of the filing
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`date." Id. "[T]he hallmark of written description is disclosure. Thus, 'possession as shown in
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`the disclosure' is a more complete formulation" of the written description requirement. Id.
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`"[T]he test requires an objective inquiry into the four comers of the specification from the
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`perspective of a person of ordinary skill in the art." Id. "[T]he written description requirement
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`does not demand either examples or an actual reduction to practice; a constructive reduction to
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`practice that in a definite way identifies the claimed invention can satisfy the written description
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`6
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`Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 8 of 21 PageID #: 44755
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`requirement." Id. at 1352. However, "a description that merely renders the invention obvious
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`does rtot satisfy the requirement." Id.
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`2.
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`Enablement
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`"Enablement is a question of law based on underlying factual findings." MagSil Corp. v.
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`Hitachi Glob. Storage Techs., Inc., 687 F.3d 1377, 1380 (Fed. Cir. 2012). "To be enabling, the
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`specification of a patent must teach those skilled in the art how to make and use the full scope of
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`the claimed invention without undue experimentation." Id. (internal quotation marks omitted).
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`"Enablement serves the dual function in the patent system of ensuring adequate disclosure of the
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`claimed invention and of preventing claims broader than the disclosed invention." Id. at
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`1380-81. "Thus, a patentee chooses broad claim language at the peril of losing any claim that
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`cannot be enabled across its full scope of coverage." Id._ at 1381. "The scope of the claims must
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`be less than or equal to the scope of the enablement to ensure that the public knowledge is
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`enriched by the patent specification to a degree at least commensurate with the scope of the
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`claims." Id. (internal quotation marks omitted).
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`"Whether undue experimentation is needed is not a single, simple factual determination,
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`but rather is a conclusion reached by weighing many factual considerations." In re Wands, 858
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`F.2d 731, 737 (Fed. Cir. 1988). These factors include "(1) the quantity of experimentation
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`necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of
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`working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative
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`skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of
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`the claims." Id. Although "a specification need not disclose what is well known in the art,"
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`"[t]ossing out the mere germ of an idea does not constitute enabling disclosure." Genentech, Inc.
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`7
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`Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 9 of 21 PageID #: 44756
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`v. Novo Nordisk AIS, 108 F.3d 1361, 1366 (Fed. Cir. 1997). A patent "cannot simply rely on the
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`knowledge ·of a person of ordinary skill to serve as a substitute for the missing information in the
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`specification." ALZA Corp. v. Andrx Pharm., LLC, ·603 F.3d 935,941 (Fed. Cir. 2010).
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`III. DISCUSSION
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`A. Written Description
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`1.
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`Written Description for Hybridization and Detection
`of Probes Labeled at Non-Ward Positions
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`Abbott seeks summary judgment that the '405 patent contains insufficient written
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`description for non-Ward-labeled probes used for hybridization and detection. (See D.I. 413 at 9)
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`In Abbott's view, the '405 patent specification "at best describes that probes ... labeled at non-
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`Ward positions could be made, would hybridize to complementary nucleic acids of interest, and
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`·would be detected," but describes no such testing. (Id. at 11) Abbott further contends that "it
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`would have been necessary to make and test [a non-Ward-labeled probe]" because, as of the
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`priority date, "non-Ward labeling was believed to be disruptive and unsuitable" and the Ward
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`. patent5 taught away from attaching a non-radioactive label to any position other than a Ward
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`position. (Id. at 9, 11 (internal quotation marks omitted; alteration in original); see also D.I. 411-
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`4 Ex. 21 at 63)
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`Enzo responds that the specification "provide[ s] numerous specific examples of labeling
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`probes at ... non-Ward positions." (D.I. 423 at 14) Specifically, Enzo contends that Example V
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`discloses phosphate labeling (see '405 patent col. 5 11. 40-53); Example XXXIII describes base
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`labeling at non-Ward positions (see '405 patent col. 411. 16-24, col. 13 11. 23-53); and the
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`5The Ward patent discloses labeling at the Ward positions of the base moiety. The '405
`patent incorporates by reference the specification of the Ward patent. (See D.I. 413 at 7; '405
`patent col. 3 11. 15-17)
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`8
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`

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`specification describes labeling at the sugar moi~ty (see '405 patent col. 3 11. 45-53). (See D.l.
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`423 at 14-15) Enzo further contends that the specification discloses that "hybridization and
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`detection are the plain purposes to which each of the above examples are directed." (Id. at 15;
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`see also '405 patent col. 29 11. 34-38) According to Enzo, a person of ordinary skill in the art
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`("POSA") would have "understood each of the examples discussed above to be a complete
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`embodiment of the claimed probes" (D.I. 423 at 15 n.10) (emphasis omitted) and.would have
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`also been aware of "a variety of additional chemistries" for labeling at non-Ward positions (id. at
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`16). Thus, in Enzo's view, "[a]t a minimum, the presence of numerous specific examples of the
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`inventions, and both sides' expert opinions regarding those examples, creates disputes of material
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`fact," precluding summary judgment. (Id. at 17)
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`The Court agrees with Enzo that genuine disputes of material fact preclude summary
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`judgment on whether the '405 patent contains sufficient written description for non-Ward(cid:173)
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`labeled probes used for hybridization and detection. (See, e.g., D.I. 411-4 Ex. 21 at 63; D.I. 427
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`at A2331-55; '405 patent col. 29 ll. 34-38) A reasonable factfinder could find, as Abbott
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`contends, that no portion of the specification discloses non-Ward-labeled probes that could
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`successfully hybridize or be detected. (See D.l. 413 at 9, 11) By contrast, a reasonable factfinder
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`could also find, as Enzo asserts, that various parts of the specification disclose non-Ward-labeled
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`polynucleotides that are useful for hybridization and detection. (See D.l. 423 at 14-16)
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`Accordingly, the Court will deny this portion of Abbott's motion for summary judgment.
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`2.
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`Written Description for the In Situ Hybridization Claims
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`Abbott seeks summary judgment that the '405 patent lacks adequate written description
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`for the claimed processes recited in the in situ hybridization claims - specifically, the processes
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`9
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`for "determining whether the number of copies of a particular chromosome in a cell is normal or
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`abnormal," "identifying a chromosome of interest in a cell containing other chromosomes," and
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`"identifying a plurality or all of the chromosomes of a cell of interest." (D .I. 413 at 15; see also
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`'405 patent col. 3411. 62-64, col. 36 11. 1-2, col. 3711. 7-8) Abbott contends that "[t]he only
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`portions of the '405 patent [that] Enzo identifies as containing any disclosure ofth[ose] processes
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`are the title and abstract," both of which were added 20 years after the priority date. (D.I. 413 at
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`15-16) (emphasis omitted) Abbott further contends that Example 9 of the Ward patent cannot
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`provide adequate written description for the in situ hybridization claims because that Example
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`was prophetic and could not be practiced until 1996. (See id. at 16; D.I. 411-4 Ex. 27 at 31-34)
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`Enzo counters that Example 9 provides sufficient written description for the in situ
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`hybridization claims because Abbott's own expert admitted that "[c]ertain embodiments· [of
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`Example 9] certainly could be practiced without question" in 1981. (D.I. 425 at A809; see also
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`D.I. 423 at 19 n;lO) Enzo further contends that "in situ hybridization with human and non(cid:173)
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`human chromosomes was well known by 1982" and, therefore, was available to a POSA as of
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`the priority date. (D.I. 423 at 9)
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`The Court concludes that the record reveals a genuine dispute of material fact with
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`respect to whether Example 9 could be practiced before the priority date. While Abbott contends
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`that the relevant portions of Example 9 could not be practiced until approximately 14 years after
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`the priority date (see D.I. 411-4 Ex. 27 at 31-34), Enzo cites record evidence that "[c]ertain
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`embodiments ... certainly could be practiced without question" before the priority date (D.I. 425
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`at A809). A reasonable jury, viewing such evidence, could find for either Abbott or Enzo on this
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`dispute.
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`10
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`Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 12 of 21 PageID #: 44759
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`Accordingly, the Court will deny this portion of Abbott's motion for summary judgment.
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`3.
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`Written Description for the Liquid Phase Claims
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`Abbott requests that the Court grant summary judgment that the '405 patent lacks
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`adequate written description for the liquid phase claims. In support, Abbott argues that the
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`specification of the '405 patent "does not describe an~ oligo- or polynucleotide ... used for
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`specific hybridization in liquid phase to detect a nucleic acid of interest in a sample," as required
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`by the liquid phase claims. (D.I. 413 at 13)
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`Enzo responds that the specification "explicitly describe[ s ]"the probes usefu~ for
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`"detection or hybridization in the liquid phase between the DNA sought to be detected and the
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`DNA detecting probe." (D.I. 423 at 15 (internal quotation marks omitted); see also '405 patent ·
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`col. 1911. 63-65; col. 2011. 1-10)) Enzo further asserts that "[h]ybridization in the liquid phase
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`was known in the art" and, therefore, available to a POSA as of the priority date. (D.I. 423 at 9)
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`The record demonstrates genuine disputes of fact with respect.to whether the.' 405 patent
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`contains adequate written description for the liquid phase claims. A reasonable jury could find
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`for either side, based on the record evidence. (See, e.g., D.I. 411-4 Ex. 28 at 163; '405 patent col.
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`1911. 63-65, col. 20 11. 1-10)
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`Accordingly, the Court will deny this portion of Abbott's motion for summary judgment.
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`B.
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`Enablement
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`Abbott seeks summary judgment that the asserted claims of the '405 patent are invalid for
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`nonenablement on the basis of the Court's reasoning in the Gen-Probe Opinion. (See GP Op.)
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`(granting summary judgment that asserted, claims of' 180 patent are invalid for nonenablement)
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`In Abbott's view, the Court's reasoning in the Gen-Probe Opinion supports invalidating the '405
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`11
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`Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 13 of 21 PageID #: 44760
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`patent on enablement grounds because "[a] specification[6
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`] that does not enable the narrower
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`scope of polynucleotides claimed in the '180 patent cannot enable the broader scope of
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`polynucleotides recited in the '405 patent." (D.I. 459 at 1; see also Tr. at 6-7, 17) Abbott further
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`contends that the claims of the '405 patent, like those of the '180 patent, "do_ not limit the length
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`or sequence of the polynucleotides and, thus, cover [the] use of at least the same millions (or
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`more) phosphate-labeled polynucleotides that were not enabled in the '180 patent." (D.I. 459 at
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`1) (internal quotation marks omitted)
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`With respect to other polynucleotides labeled at non-Ward positions, Abbott asserts that
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`Enzo "cannot identify any Example [in the '405 patent's specification] that describes [the]
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`chemistry for the vast majority of the other non-Ward labeling positions that the '405 patent
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`seeks to capture," including the chemistry for all non-Ward base labeling positions. (Id. at 2)
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`Abbott further argues that the methods disclosed in the asserted claims are not enabled because
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`Enzo's expert, Dr. Sherman, admitted that "there [is] no data in the '405 patent showing that a
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`probe labeled at a non-Ward position ... would successfully hybridize." (DJ. 459-1 Ex. 6 at
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`193-94) According to Abbott, the lack of any such experiment being reported in the specification
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`establishes that a POSA would have had to engage in "undue experimentation" in order to
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`confirm that non-Ward-labeled probes work, given the "vast number of possible variants to the
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`claimed invention." (D.I. 459 at 2) (internal quotation marks omitted)
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`Enzo responds that "the '405 [p ]atent specification describes in great detail a wide variety
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`of non-radioactively[-]labeled polynucleotides that can be used in the claimed methods, including
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`probes labeled ... at ... non-Ward positions." (D.I. 461 at 3) (citing '405 patent col. 3 11. 20-67,
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`6lt is undisputed that the specifications of the '405 patent and '180 patent are identical in
`relevant part. (See Tr. at 6)
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`Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 14 of 21 PageID #: 44761
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`col. 411. 1-24, col. 5 11. 40-53, col. 1211. 48-67, col. 13 11. 1-54, col. 2211. 56-67, cols. 23-24, col.
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`25 11. 1-66 as disclosing probes labeled at sugar, phosphate, and certain base moieties) Enzo
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`further contends that "skilled artisans were aware of additional chemistries for attaching labels at
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`the other non-Ward positions" that are not explicitly disclosed in the specification. (Id.) In
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`Enzo' s view, the variations in "polynucleotide sequence, length, labels, linkers, and position of
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`labeling" would not "render any application of the claimed methods inoperable" and, therefore, a
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`POSA could practice the invention "without engaging in undue (if any) experimentation." (Id. at
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`2-3) (emphasis omitted)
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`According to Enzo, the specific limitations recited in the asserted claims are adequately
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`described in the specification or were already known in the art. With respect to the in situ
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`hybridization claims in particular, Enzo notes that Abbott's expert admitted that "the practice of
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`the claimed methods would have been enabled with over 50 differentprobe designs and that
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`deploying those alleged probes in the claimed in situ hybridization processes would have yielded
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`predictable results." (D.I. 461 at 5) (internal quotation marks and emphasis omitted) Enzo
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`further contends that the specification's disclosure of probes labeled at non-Ward positions
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`would also have enabled a POSA to practice the in situ hybridization claims. (See id. at 4; see
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`also id. at 3)
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`At oral argument, Enzo' s counsel further argued that the embodiments recited in the
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`liquid phase claims were "irrelevant" because "[t]he novelty ofliquid phase hybridization claims
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`lies ... in the inventive combination of performing liquid phase hybridization with a non(cid:173)
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`radioactive probe, whatever the structure of the probe, followed by detection." (Tr. at 24-25) As
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`such, in Enzo' s view, "the exact nature, structure, location of labeling, sequence, etc. of the non-
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`Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 15 of 21 PageID #: 44762
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`radioactive[ly]-labeled probe is tangential to the invention" and, thus, cannot "render the
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`invention [recited in the liquid phase claims] invalid for lack of enablement." (See id. at 26-27;
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`see also id. at 31-32 (citing '405 patent col. 19 11. 62-67, col. 20 11. 2-10, 26-43 as providing
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`support for counsel's argument that "the novelty [of the invention] ... lies in the use of [a]
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`particular type of hybridization in the liquid phase ... using non-radioactive labels, followed by
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`detection of those labels"))
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`In its reply, Abbott argues that Enzo's opposition "repeat[s] arguments that the Court has
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`already rejected" in the Gen-Probe Opinion. (D.I. 462 at 1) (emphasis omitted) Specifically,
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`Abbott notes that even though the Court has already concluded that "no 'part[] of the
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`specification indicates whether an internal phosphate-labeled polynucleotide maintain[s]
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`hybridizability· and detectability"' (id.) (quoting GP Op. at 15; second alteration in original),
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`Enzo insists that the specification of the '405 patent "'completely' discloses polynucleotides
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`'labeled at the phosphate moiety"' (id.) (quoting D.I. 461 at 1). In Abbott's view, given the lack
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`of disclosure in the specification, a POSA would be required to engage in undue experimentation
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`to identify and determine whether the claimed phosphate-, sugar-, and base-labeled
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`polynucleotides "might be useful in the claimed processes." (Id.) Abbott further contends that a
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`POSA would have considered non-Ward-labeled probes to be inoperative, in view of the state of
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`the art at the pertinent time. (See id. at 2) 7
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`While Enzo contends that the specification discloses the limitations of the asserted
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`claims, Abbott replies that "[t]he '405 patent does not describe the claimed in situ hybridization
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`7The Court agrees with Abbott that while inoperability can be a basis for nonenablement,
`it is not a prerequisite to a finding ofnonenablement. (See D.I. 462 at 2) (citing Wyeth & Cordis
`Corp. v. Abbott Labs., 720 F.3d 1380, 1384 (Fed. Cir. 2013))
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`Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 16 of 21 PageID #: 44763
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`processes at all" and also fails to "describe[] ... the conditions (e.g. probe concentration,
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`temperature, salt concentration, etc.) under which the [liquid-phase] process[ es] can occur." (Id.)
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`(citing testimony ofEnzo's expert that liquid-phase hybridization "depends on such conditions")
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`Abbott further asserts that the distinction between the '180 and '405 patent claims "makes no
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`difference" to the Court's analysis: although "the '180 patent claims products [and] the '405
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`patent claims processes," the claimed processes of the '405 patent "depend on the hybridizability
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`and detectability of the claimed probes." (Id.) "Without enabled probes," Abbott argues, "the
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`processes [Claimed in the '405 patent] cannot be enabled." (Id.; see also id. at 1 (arguing that
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`certain probes are not enabled to maintain hybridizability and detectability); Tr. at 9 (counsel for
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`Abbott asserting that "[t]he '405 patent claims are process claims, but this only makes them less
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`enabled, not more"))
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`"To prove that a claim is invalid for lack of enablement, a challenger must show by clear
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`and convincing evidence that a person of ordinary skill in the art would not be able to practice the
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`claimed invention without 'undue experimentation."' Alcon Research Ltd. v. Barr Labs., Inc.,
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`745 F.3d 1180, 188 (Fed. Cir. 2014) (quoting Wands, 858 F.2d at 736-37). Having applied this
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`standard to the record evidence, and taking that evidence in the light most favorable to Enzo as
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`the non-moving party, the Court concludes that there is no genuine dispute of fact that the
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`asserted claims of the '405 patent are nonenabled. A reasonable jury could not find for Enzo.
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`Instead, the only conclusion a reasonable jury could reach is that clear and convincing evidence
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`proves the '405 patent is invalid for noneablement.
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`"[T]he specification must teach those of skill in the art how to make and how to use the
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`invention as broadly as it is claimed." In re Goodman, 11F.3d1046, 1050 (Fed. Cir. 1993)
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`Case 1:12-cv-00274-LPS Document 467 Filed 08/15/17 Page 17 of 21 PageID #: 44764
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`(internal quotation marks omitted; emphasis added). Here, even though the specifications of the
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`'180 and.' 405 patents are identical in all relevant respects, the asserted claims of the '405 patent
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`are even broader than the asserted claims of the '180 patent that the Court invalidated as
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`nonenabled in the Gen-Probe Opinion. (See GP Op.; D.I. 449-1 Ex. 4 at 148-49) Give