Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 1 of 40 PageID #: 26049
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`BD Exhibit 1010
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`

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`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 2 of 40 PageID #: 26050
`Case 1:12—cv—OO104—LPS Document 181 Filed 07/07/15 Page 2 of 40 Page|D #: 26050
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`ENZO LIFE SCIENCES, INC.,
`
`Plaintiff.
`
`V.
`
`BECTON, DICKINSON AND COMPANY;
`
`et al.,
`
`Defendants.
`
`ENZO LIFE SCIENCES, INC.,
`
`Plaintiff.
`
`V.
`
`HOLOGIC, INC.,
`
`Defendant.
`
`ENZO LIFE SCIENCES, lNC.,
`
`Plaintiff.
`
`V.
`
`AFFYMETRIX, INC.,
`
`Defendant.
`
`ENZO LIFE SCIENCES, INC.,
`
`Plaintiff.
`
`V.
`
`AGILENT TECHNOLOGIES, INC.,
`
`Defendant.
`
`C.A. N0. l2—275—LPS
`
`C.A. No. 12-276—LPS
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`C.A. No. 12-433-LPS
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`C.A. No. 12-434-LPS
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`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 3 of 40 PageID #: 26051
`Case 1:12—cv—00104—LPS Document 181 Filed 07/07/15 Page 3 of 40 Page|D #: 26051
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`C.A. No. 12-435-LPS
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`C.A. No. 12-505-LPS
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`) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) )
`
`ENZO LIFE SCIENCES, INC.,
`
`Plaintiff.
`
`V.
`
`ILLUMINA, INC.,
`
`Defendant.
`
`ENZO LIFE SCIENCES, INC.,
`
`Plaintiff.
`
`v.
`
`SIEMENS HEALTHCARE DIAGNOSTICS,
`
`INC.,
`
`Defendant.
`
`Brian E. Farnan, FARNAN LLP, Wilmington, DE
`John M. Desmarais, Michael P. Stadnick, Jordan Malz, Justin P.D. Wilcox, Peter C. Magic,
`Joseph C. Akalski, Jessica A. Martinez, Danielle A. Shultz, DESMARAIS LLP, New York, NY
`
`Attorneys for Plaintiff.
`
`Karen L. Pascale, Pilar G. Kraman, YOUNG CONAWAY STARGATT & TAYLOR LLP,
`Wilmington, DE
`Matthew M. Wolf, ARNOLD & PORTER LLP, Washington, DC
`Jennifer Sklenar, Wallace Wu, ARNOLD & PORTER LLP, Los Angeles, CA
`
`Attorneys for Defendants Hologic, Inc. and Gen-Probe Incorporated
`
`Jack B. Blumenfeld, Karen Jacobs, Michael J. Flynn, MORRIS, NICHOLS, ARSHT &
`TUNNELL LLP, Wilmington, DE
`Ron E. Shulrnan, Terry Kearney, Michael R. Seringhaus, LATHAM & WATKINS LLP, Menlo
`Park, CA
`Jennifer R. Saionz, LATHAM & WATKINS LLP, New York, NY
`Ryan R. Owens, LATHAM & WATKINS LLP, Costa Mesa, CA
`Jennifer Koh, LATHAM & WATKINS LLP, San Diego, CA
`Katherine Nolan-Stevaux, THERMO FISHER SCIENTIFIC INC., Foster City, CA
`
`Attorneys for Defendant Life Technologies Corporation
`
`
`
`

`
`
`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 4 of 40 PageID #: 26052
`Case 1:12—cv—00104—LPS Document 181 Filed 07/07/15 Page 4 of 40 Page|D #: 26052
`
`: i
`
`tt 2
`
`Frederick L. Cottrell, III, Katharine C. Lester, RICHARDS, LAYTON & FINGER, P.A.,
`Wilmington, DE
`William G. McElwain, Jamie T. Wisz, WILMER CUTLER PICKERING HALE AND DORR
`LLP, Washington, DC
`Robert J. Gunther, Jr., Jane M. Love, PhD., Omar Khan, Christopher R. Noyes, WILMER
`CUTLER PICKERING HALE AND DORR LLP, New York, NY
`
`Gregory P. Teran, WILMER CUTLER PICKERING HALE AND DORR LLP, Boston, MA
`William W. Kim, WILMER CUTLER PICKERING HALE AND DORR LLP, Palo Alto, CA
`
`Attorneys for Defendants Becton, Dickinson and Company, Becton Dickinson
`Diagnostics Inc., and Geneohm Sciences, Inc., Roche Molecular Systems, Inc., Roche
`Diagnostics Operations, Inc., Roche Diagnostics Corporation, and Roche Nimb1eGen,
`Inc.
`
`Richard L. Horwitz, David E. Moore, Bindu A. Palapura, POTTER ANDERSON & CORROON
`LLP, Wilmington, DE
`James F. Hurst, Maureen Rurka, Elizabeth Thompson, WINSTON & STRAWN LLP, Chicago,
`IL
`
`Melinda Lackey, WINSTON & STRAWN LLP, Houston, TX
`
`Attorneys for Defendants Abbott Laboratories and Abbott Molecular Inc.
`
`Denise S. Kraft, Brian A. Biggs, DLA PIPER LLP, Wilmington, DE
`John Guaragna, Aaron G. Fountain, DLA PIPER, Austin, TX
`Stanley Panikowski, Erica Pascal, DLA PIPER, San Diego, CA
`
`Attorneys for Intervenor-Defendant and Counterclaim—Plaintiff Luminex Corporation
`
`Jack B. Blumenfeld, Maryellen Noreika, Derek J . Fahnestock, MORRIS, NICHOLS, ARSHT &
`TUNNELL LLP, Wilmington, DE
`Michael J . Malecek, Peter E. Root, Sean M. Boyle, KAYE SCHOLER LLP, Palo Alto, CA
`
`Attorneys for Defendant Affymetrix Inc.
`
`Jack B. Blumenfeld, Maryellen Noreika, Derek J . Fahnestock, Paul Saindon, Ethan H.
`Townsend, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE
`
`Attorneys for Defendant Agilent Technologies, Inc.
`
`Steven J . Balick, Lauren E. Maguire, ASHBY & GEDDES, Wilmington, DE
`Kevin M. Flowers, Mark H. Izraelewicz, Cullen N. Pendleton, Amanda K. Antons,
`MARSHALL, GERSTEIN & BORUN LLP, Chicago, IL
`
`Attorneys for Defendant Illumina, Inc.
`
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`
`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 5 of 40 PageID #: 26053
`Case 1:12—cv—00104—LPS Document 181 Filed 07/07/15 Page 5 of 40 Page|D #: 26053
`
`Jack B. Blumenfeld, Derek J. Falmestock, MORRIS, NICHOLS, ARSHT & TUNNELL LLP,
`
`Wilmington, DE
`Nagendra Setty, George L. Kanabe, ORRICK, HERRINGTON & SUTCLIFFE LLP, San
`Francisco, CA
`Anthony C. Kuhlmann, ORRICK, HERRINGTON & SUTCLIFFE LLP, Irvine, CA
`Ryan C. Micallef, ORRICK, HERRINGTON & SUTCLIFFE LLP, New York, NY
`
`Attorneys for Defendants Siemens Healthcare Diagnostics Inc.
`_?
`
`MEMORANDUM OPINION
`
`July 7, 2015
`Wilmington, Delaware
`
`

`
`
`
`ST
`
`P. M
` isflictJudge:
`
`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 6 of 40 PageID #: 26054
`Case 1:12—cv—00104—LPS Document 181 Filed 07/07/15 Page 6 of 40 Page|D #: 26054
`
`
`
`
`
`I The ‘ 197 patent is entitled “System, array and non-porous solid support comprising
`fixed or immobilized nucleic acids,” issued on June 20, 2006, and claims priority to January
`27, 1983.
`
`Plaintiff Enzo Life Sciences, Inc. (“Plaintiff” or “Enzo”) filed patent infringement
`
`actions against Defendants Abbott Laboratories, Abbott Molecular Inc., Luminex Corp.,
`
`Becton, Dickinson and Company, Becton Dickinson Diagnostics Inc., Geneohm Sciences,
`
`Inc., Gen-Probe, Inc., Hologic, Inc., Life Technologies Corp., Luminex Corp., Roche
`
`Molecular Systems, Inc., Roche Diagnostics Corp., Roche Diagnostic Operations, Inc., and
`
`Roche Nimblegen, Inc. (“Defendants”) for infringement of one or more of the following
`
`patents: U.S. Patent No. 7,064,197 (“the ‘197 patent”),' U.S. Patent No. 6,992,180 (“the ‘180
`
`patent”),2 and U.S. Patent No. 8,097,405 (“the ‘405 patent”).3 The ‘180 and ‘405 patents,
`
`which relate generally to nucleic acid detection technology, are part of the same family and
`
`share nearly identical specifications.
`
`Pending before the Court is the issue of claim construction of Various disputed terms
`
`of the patents-in-suit. The parties completed briefing on claim construction on July 22,
`
`2014.
`
`(C.A. No. 12-274-LPS D.I. 133; C.A. No. 12-104-LPS D.I. 77) In addition to the
`
`briefing, the parties also submitted technology tutorials. (C.A. No. 12-274-LPS D.l. 163,
`
`164; C.A. No. 12- 104-LPS D.l. 91, 92) The Court held a Markman hearing on August 18,
`
`2014. (See C.A. No. 12-274-LPS 13.1. 133; C.A. No. 12-104-LPS 13.1. 77) (“Tr.”)
`
`2 The ‘180 patent is entitled “O1igo— or polynucleotides comprising phosphate-moiety
`labeled nucleotides,” issued on January 31, 2006, and claims priority to June 23, 1982.
`
`11
`
`I
`
`
`
`
`
`
`
`
`3 The ‘405 patent is entitled “Nucleic Acid Sequencing Processes Using Non-
`Radioactive Detectable Modified or Labeled Nucleotides or Nucleotide Analogs, and Other
`Processes For Nucleic Acid Detection and Chromosomal Characterization Using Such Non-
`Radioactive Detectable Modified or Labeled Nucleotides or Nucleotide Analogs,” issued on
`January 17, 2012, and claims priority to June 23, 1982.
`
`1
`
`
`
`

`
`
`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 7 of 40 PageID #: 26055
`Case 1:12—cv—00104—LPS Document 181 Filed 07/07/15 Page 7 of 40 Page|D #: 26055
`
`1.
`
`LEGAL STANDARDS
`
`The ultimate question of the proper construction of the patent is a question of law.
`
`Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 837 (2015) (citing Markman v.
`
`Westview Instruments, Inc., 517 U.S. 370, 388-91 (1996)). “It is a bedrock principle of patent
`
`law that the claims of a patent define the invention to which the patentee is entitled the right to
`
`exclude.” Phillips v. A WH Corp, 415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotation
`
`marks omitted). “[T]here is no magic formula or catechism for conducting claim
`
`construction.” Phillips, 415 F.3d at 1324. Instead, the court is free to attach the appropriate
`
`weight to appropriate sources “in light of the statutes and policies that inform patent law.” Id.
`
`“[T]he words of a claim are generally given their ordinary and customary meaning .
`
`.
`
`.
`
`[which is] the meaning that the term would have to a person of ordinary skill in the art in
`
`question at the time of the invention, i.e., as of the effective filing date of the patent
`
`application.” Id. at 1312-13 (internal citations and quotation marks omitted). “[T]he ordinary
`
`meaning of a claim term is its meaning to the ordinary artisan after reading the entire paten .”
`
`Id. at 1321 (internal quotation marks omitted). The patent specification “is always highly
`
`relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide
`
`to the meaning of a disputed term.” Vitronics Corp v. Conceptronic, Inc., 90 F.3d 1576, 1582
`
`(Fed. Cir. 1996).
`
`While “the claims themselves provide substantial guidance as to the meaning of
`
`particular claim terms,” the context of the surrounding words of the claim also must be
`
`considered. Phillips, 415 F.3d at 1314. Furthermore, “[o]ther claims of the patent in question,
`
`both asserted and unasserted, can also be valuable sources of enlightenment .
`
`.
`
`. [b]ecause
`
`claim terms are normally used consistently throughout the patent .
`
`.
`
`. .” Id. (internal citation
`
`2
`
`
`
`

`
`
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`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 8 of 40 PageID #: 26056
`Case 1:12—cv—00104—LPS Document 181 Filed 07/07/15 Page 8 of 40 Page|D #: 26056
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`
`
`omitted).
`
`!
`
`
`
`It is likewise true that “[d]ifferences among claims can also be a useful guide .
`.
`.
`. For
`example, the presence of a dependent claim that adds a particular limitation gives rise to a
`presumption that the limitation in question is not present in the independent claim.” Id. at
`1314- 15 (internal citation omitted). This “presumption is especially strong when the
`
`limitation in dispute is the only meaningful difference between an independent and dependent
`
`claim, and one party is urging that the limitation in the dependent claim should be read into
`
`the independent claim.” SunRace Roots Enter. Co., Ltd. v. SRAM Corp, 336 F.3d 1298,
`
`1303 (Fed. Cir. 2003).
`
`It is also possible that “the specification may reveal a special definition given to a
`
`claim term by the patentee that differs from the meaning it would otherwise possess. In such
`
`cases, the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316. It bears emphasis
`
`that “[e]ven when the specification describes only a single embodiment, the claims of the
`
`patent will not be read restfictively unless the patentee has demonstrated a clear intention to
`
`limit the claim scope using words or expressions of manifest exclusion or restriction.” Liebel—
`
`Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004) (internal quotation marks
`
`omitted), afl’d, 481 F.3d 1371 (Fed. Cir. 2007).
`
`In addition to the specification, a court “should also consider the patent’s prosecution
`
`history, if it is in evidence.” Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed.
`
`Cir. 1995), afi”’d, 517 U.S. 370 (1996). The prosecution history, which is “intrinsic evidence,”
`
`“consists of the complete record of the proceedings before the PTO [Patent and Trademark
`
`Office] and includes the prior art cited during the examination of the patent.” Phillips, 415
`
`F.3d at 1317. “[T]he prosecution history can often inform the meaning of the claim language
`
`3
`
`

`
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`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 9 of 40 PageID #: 26057
`Case 1:12—cv—00104—LPS Document 181 Filed 07/07/15 Page 9 of 40 Page|D #: 26057
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`by demonstrating how the inventor understood the invention and whether the inventor limited
`
`the invention in the course of prosecution, making the claim scope narrower than it would
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`otherwise be.” Id.
`
`In some cases, “the district court will need to look beyond the patent’s intrinsic
`
`evidence and to consult extrinsic evidence in order to understand, for example, the background
`
`science or the meaning of a term in the relevant art during the relevant time period.” Teva,
`
`135 S. Ct. at 841. Extrinsic evidence “consists of all evidence external to the patent and
`
`prosecution history, including expert and inventor testimony, dictionaries, and learned
`
`treatises.” Markman, 52 F.3d at 980. For instance, technical dictionaries can assist the court
`
`in determining the meaning of a term to those of skill in the relevant art because such
`
`dictionaries “endeavor to collect the accepted meanings of terms used in various fields of
`
`science and technology.” Phillips, 415 F.3d at 1318.
`
`In addition, expert testimony can be
`
`useful “to ensure that the court’s understanding of the technical aspects of the patent is
`
`consistent with that of a person of ordinary skill in the art, or to establish that a particular term
`
`in the patent or the prior art has a particular meaning in the pertinent field.” Id. Nonetheless,
`
`courts must not lose sight of the fact that “expert reports and testimony [are] generated at the
`
`time of and for the purpose of litigation and thus can suffer from bias that is not present in
`
`intrinsic evidence.” Id. Overall, while extrinsic evidence “may be useful” to the court, it is
`
`“less reliable” than intrinsic evidence, and its consideration “is unlikely to result in a reliable
`
`interpretation of patent claim scope unless considered in the context of the intrinsic evidence.”
`
`Id. at 1318-19. Where the intrinsic record unambiguously describes the scope of the patented
`
`invention, reliance on any extrinsic evidence is improper. See Pitney Bowes, Inc. v. Hewlett-
`
`Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90 F.3d at 1583).
`
`4
`
`
`
`

`
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`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 10 of 40 PageID #: 26058
`Case 1:12—cv—00104—LPS Document 181 Filed 07/07/15 Page 10 of 40 Page|D #: 26058
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`Finally, “[t]he construction that stays true to the claim language and most naturally
`
`aligns with the patent’s description of the invention will be, in the end, the correct
`
`construction.” Renishaw PLC v. Marposs Societa ’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir.
`
`1998). It follows that “a claim interpretation that would exclude the inventor’s device is rarely
`
`the correct interpretation.” Osram GmbH v. Int ’l Trade Comm ’n, 505 F.3d 1351, 1358 (Fed.
`
`Cir. 2007).
`
`II.
`
`THE ‘197 PATENT‘
`
`A.
`
`Agreed-Upon Claim Terms
`
`The parties agree on the proper construction for the following claim terms:
`
`Claim Term/Phrase
`
`Agreed-Upon Construction
`
`hybridizable form
`
`Capable of binding through Watson-Crick base
`pairing
`
`
`
`having different nucleotide sequences
`
`The Court will adopt the agreed-upon constructions.
`
`B.
`
`Disputed Claim Terms
`
`1.
`
`“non-porous”
`
`Plaintifi”s Proposal:
`
`No construction necessary.5
`
`Not full of minute holes throu which fluid may Defendants "’ Proosal:
`
`Orin the alternative
`
`Havin
`
`ores, e. ; .,, havin; no nooks or crannies
`
`4 All citations in Section II are to C.A. No. 12-274—LPS, unless specified otherwise.
`
`5 Plaintiff’ s primary preference with respect to each of the disputed terms in the ‘ 197
`patent is for the Court to simply adopt the plain language. However, as was made clear during
`the claim construction hearing, there are genuine disputes with respect to the proper construction
`of each of the terms discussed here. Under these circumstances, adopting an unspecified “plain
`meaning” would leave the door open to multiple reasonable constructions to be advocated later in
`the case, with the nearly-certain improper result that the parties would try claim construction to
`the factfinder.
`
`5
`
`
`
`

`
`
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`
`
`
`
`i
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`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 11 of 40 PageID #: 26059
`Case 1:12—cv—00104—LPS Document 181 Filed 07/07/15 Page 11 of 40 Page|D #: 26059
`
`Life Technologies ’ Proposal: A solid support having an impermeable surface without pores,
`e. g., without nooks and crannies7
`
`Having no pores
`
`C0urt’s Construction:
`
`The parties have two primary disputes with respect to “non-porous.”8 First, they
`
`dispute whether “non-porous” means “not full of holes,” “having no pores,” or “having an
`
`impermeable surface without pores.” Second, the y dispute whether pores are “minute holes
`
`through which fluid may pass” or, instead, are “nooks and crannies.”
`
`The patent specification identifies “non-porous” materials “such as glass, or
`
`alternatively, plastic, polystyrene, polyethylene, dextran, polypropylene, and like” and
`
`contrasts these with “[c]onventional porous materials, e.g., nitrocellulose filters.” (‘ 197 patent,
`
`col. 6 11. 4-9; see also D.I. 201 at 3 (“Enzo’s construction is grounded in the intrinsic evidence,
`
`which cites glass, plastic, and polystyrene as examples of non-porous materials — none of
`
`which pennit the passage of fluid — and a filter as an example of a porous material — which
`
`does permit the passage of fluid.”)) Beyond this, however, the specification provides little
`
`additional guidance as to the proper construction of “non-porous.”
`
`The prosecution history makes clear that “[t]he key to the invention was getting nucleic
`
`acids to reliably bind in hybridizable form to the surface of a non-porous material .
`
`. .” (D.I.
`
`161-62 Ex. B-8 at ENZO-0019424) (emphasis in original) “As the nucleic acids form a
`
`monolayer, saturating the surface .
`
`.
`
`. the nucleic acids are favorably placed to take part in
`
`6 All Defendants except Life Technologies.
`
`7 Life Technologies takes the position that the larger phrase “non-porous solid support”
`should be construed as a whole, rather than in two separate parts, which is the position of
`Plaintiff and the remainder of the Defendants. Ho wever, since Life’s proposal only construes
`the phrase “non-porous” and incorporates the term “solid support” into its proposal, the Court
`finds Life’s construction is essentially a competing construction for “non-porous.”
`
`El
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`

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`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 12 of 40 PageID #: 26060
`Case 1:12—cv—OO104—LPS Document 181 Filed 07/07/15 Page 12 of 40 Page|D #: 26060
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`hybridization reactions. Interactions with the solutions phase are much faster, because
`
`molecules do not have to diffuse into and out of the pores.” (Id. at ENZO-0019427) This
`
`history supports Defendants’ contention that “non—porous” means “having no pores.”
`
`Enzo’s alternative construction, adding “not full of minute holes,” creates ambiguity.
`
`(See C.A. 12-106 D.I. 108 at 3) Under this construction, a glass plate with a single pore would
`
`not be considered porous (because it would not be “full” of pores), even thought it would
`
`allow fluid to travel into and out of the support. The Court also rejects Defendants’ addition of
`
`“nooks and crannies,” as this limitation is not required by any intrinsic evidence (including the
`
`prosecution history). (See D.I. 161-62 Ex. B-8 at ENZO-0019427 (“The uniformity of these
`
`non- porous solid supports, which stands in contrast to the nooks and crannies of porous
`
`supports in the prior art. .
`
`. ”)) Lastly, Life Technologies’ proposal would improperly read into
`
`the claim language a limitation based solely on the disclosed embodiments in the specification,
`
`a limitation that is not present in the claim itself.
`
`2.
`
`“solid support”
`
`No construction necessary.
`
`Or in the alternative:
`
`solid structure
`
` Plaintzfi”s Proposal:
`
`
`
`
`
`
`
`Defendants ’ Proposal:
`
`a solid structure for containing fluid
`
`Court’s Construction:
`
`a solid structure
`
`The parties dispute whether a solid support must “contain[] fluid.” As is evident from
`
`the plain language of the claims and the intrinsic evidence, the shape of the claimed support is
`
`not limited. Defendants’ proposed limitation is based on the disclosed embodiments in the
`
`
`
`

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`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 13 of 40 PageID #: 26061
`Case 1:12—cv—00104—LPS Document 181 Filed 07/07/15 Page 13 of 40 Page|D #: 26061
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`specification, and the assumption that the support must “contain[] fluid” in order for the
`
`soluble signaling moiety to dissolve. (See C.A. 12-106 D.I. 98 at 12 (“The ability to contain
`
`fluid is critical because the hybridization assays of the ‘ l97 patent all involve the use of a
`
`soluble signal and the solid support must be able to contain the fluid solution in which the
`
`soluble signal is dissolved.”))
`
`But Defendants’ proposed limitation is not supported by the claim language. Claims
`
`33 and 40 refer to solid supports comprising “a plate or plates.” (‘ 197 patent, col. 17 11. 9-10,
`
`32-33) While Defendants argue that this must be in reference to the flat, plate-like surface of
`
`a petri dish,9 that is not what is stated in the claims. The prosecution history also refers to a
`
`slide as solid support. (See D.I. l6l-60 Ex. B-3 at ENZO—00l7734) Defendants’ construction
`
`would read disclosed embodiments out of the claims.”
`
`3.
`
`“array”
`
`No construction necessary.
`
` Plaintzfl’s Proposal:
`
`
`an orderly grouping or arrangement
`Or in the alternative:
`
`
`one or more solid supports having a defined, ordered
`Defendants ’ Proposal:
`arrangement of separate fluid-containing areas
`
`
`
`.,,......;.i..._..‘;.;u_,.u4...sm.«---
`
`
`
`
`
`‘“u...m.m..m.1..m.n.....a..u.;.....t..u.m..;i.mg;‘.._;.._1m....t.....u..4m.a..t..:;.n...z.:;.....i.a.,...=.;.a»a......t....2.-_..»:.....»......,.1.,-...s...-...
`
`Court’s Construction:
`
`an orderly grouping or arrangement
`
`
`
`
`
`9 A petn' dish, Defendants argue, contains liquid. Other examples of “plates” which
`contain fluid in the specification include: “[G]lass plates” with wells or depressions (‘ 197
`patent, col. 8 11. 66-67); “microtiter well plates (id. at col. 12 11. 54-58); and “polystyrene
`plates” (id. at col. ll 1. 58, col. 1211. 8-10).
`
`10 Defendants assume, and additionally argue, that the solid support must contain fluid
`because the soluble signal of the signaling moiety must be dissolved in liquid. This position is
`based on Defendants’ proposed construction of “signaling moiety” which, as explained below,
`the Court has rejected.
`
`

`
`
`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 14 of 40 PageID #: 26062
`Case 1:12—cv—00104—LPS Document 181 Filed 07/07/15 Page 14 of 40 Page|D #: 26062
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`1
`
`The parties have two disputes related to the construction of “array”: (1) whether an
`
`“array” is a “defined, ordered arrangement” or instead an “orderly grouping or arrangement,”
`
`and (2) whether the “array” requires separate fluid-containing areas.
`
`The phrase “orderly grouping or arrangement,” as proposed by Enzo, comes from the
`
`prosecution history.
`
`(See D.I. 161-62 Ex. B-8 at ENZO-0019445 (“The everyday meaning of
`
`array is an orderly grouping or arrangement.”)) Defendants contend that in order to identify
`
`the hybridized nucleic acids, the arrangement must be “defined, ordered.” (See id. at ENZO-
`
`O019444) The support for Defendants’ narrower proposal are statements in the prosecution
`
`history which do not refer to the present invention. (See D.I. 161-86 at ENZO-0019002,
`
`ENZO-0018989 (“ordered”); D.I. 161-62 at ENZO-0019444 (“defined”)) The Court adopts
`
`Plaintiff’ s proposal of an “orderly grouping or arrangement.”
`
`The term “array” appears in claims 17, 18, 19, 20, 21, and 22 in reference to “an array
`
`comprising [various] .
`
`.
`
`. nucleic acids.” (‘197 patent, col. 15 l. 51 — col.l6 1. 14) “Array” is
`
`also in claims 25 and 26, which are expressly limited to “an array comprising various .
`
`.
`
`.
`
`nucleic acids fixed or immobilized .
`
`.
`
`. to a non-porous support having wells or depressions.”
`
`(‘197 patent, col. 16 11. 20-28) Defendants’ effort to limit “array” based on the specification’s
`
`reference to “glass plates provided with an array of depressions or wells” (‘ 197 patent, col. 8
`
`11. 66-67) is inconsistent with the use of the term in the various claims noted above: claims 17-
`
`22 do not call out arrays having depressions or wells, unlike claims 25 and 26 (which do). It
`
`
`
`follows that the patentee limited some, but not all, claims to arrays having depressions or
`
`wells.“
`
`“ As suggested by the parties at the hearing, the Court’s decision on this dispute is
`
`9
`
`

`
`
`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 15 of 40 PageID #: 26063
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`4.
`
`“one or more amine(s) hydroxyl(s) or epoxide(s) thereon,” “via
`said one or more amine(s), hydroxyl(s) or epoxide(s)”
`
`Plaintzfi”s Proposal:
`
`No construction necessary.
`
`Court’s Construction:
`
`Or in the alternative:
`
`Defendants ’ Proposal:
`
`one or more amine(s), hydroxyl(s) or epoxide(s) on the solid
`support; through said one or more amine(s), hydroxyl(s) or
`epoxide(s) on the solid support
`
`one or more amine(s), hydroxyl(s) or epoxide(s) present on the
`solid support; by said one or more amine(s), hydroxyl(s), or
`epoxide(s) that are present on the solid support
`
`one or more amine(s), hydroxyl(s) or epoxide(s) present on the
`solid support; by said one or more amine(s), hydroxyl(s), or
`epoxide(s) that are present on the solid support
`
`At the hearing, the parties indicated that this term is no longer in dispute. (See Tr. 69, 72)
`
`5.
`
`“signaling moiety”
`
`Plaintzfl’s Proposal:
`
`Defendants ’ Proposal:
`
`Court’s Construction:
`
`that portion of a label which on covalent attachment or non-
`covalent binding to a polynucleotide or oligonucleotide
`sequence or to a bridging moiety attached or bound to that
`sequence provides a signal for detection of the label
`
`that portion of a label which on covalent attachment or non-
`covalent binding to a polynucleotide or oligonucleotide
`sequence or to a bridging moiety attached or bound to that
`sequence provides a soluble signal for detection of the label
`
`that portion of a label which on covalent attachment or non-
`covalent binding to a polynucleotide or oligonucleotide
`sequence or to a bridging moiety attached or bound to that
`sequence provides a signal for detection of the label
`
`The ‘ 197 patent defines the “signaling moiety” as “[t]hat portion of a label which on
`
`covalent attachment or non-covalent binding to a polynucleotide or oligonucleotide sequence
`
`or to a bridging moiety attached or bound to that sequence provides a signal for detection of
`
`largely compelled by its resolution of the earlier dispute over “solid support.” (See Tr. 59, 60)
`
`10
`
`
`
`.-m»~..g.._.aa....ui.»»._.n..u.a..m.m%...m.u..;.ma:_s._u.i‘...-...m.«..,...A-u.....A..s;..vv.....,..-
`
`
`
`
`
`
`
`

`
`
`
`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 16 of 40 PageID #: 26064
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`
`
`
`
`
`
`12 The only explicit reference to an insoluble signal is in reference to prior art.
`(‘197 patent, col. 41. 66 - col. 5 l. 4)
`
`signal.
`
`Defendants rely on Trading Techs. Int ’l, Inc. v. eSpeed, Inc., 595 F.3d 1340, 1353 (Fed.
`
`Cir. 2010), to argue that the Court can reconstrue a claim “based on its .
`
`.
`
`. understanding of the
`
`claims, specification, prosecution history, and record,” notwithstanding an express definition in
`
`a specification. Even so, here Defendants provide no persuasive basis for the Court to
`
`reconstrue “signaling moiety” to mean anything other than the special definition it is given in
`
`the specification. Unlike in Trading Technologies, where the definition in the specification
`
`“expressly promise[d] to discuss [the relevant term] later in the specification,” and the Court’s
`
`construction took account of that later discussion (z'd.), here the definition of “signaling moiety”
`
`is set forth completely in one place in the specification.
`
`Furthermore, during prosecution, the patentee removed the word “soluble” from its
`
`1 1 I lI l E
`
`the label.” (‘ 197 patent, col. 2 11. 1-5) The parties’ dispute is whether that signal must be
`
`soluble. Defendants argue that the specification and prosecution history clearly show that the
`
`present invention contemplates only a soluble signal.
`
`“[A] definition set forth in the specification governs the meaning of the claims. When
`
`the specification explains and defines a term used in the claims, without ambiguity or
`
`incompleteness, there is no need to search further for the meaning of the term.” Sinorgchem
`
`C0., Shandong v. Int ’l Trade Comm ’n, 511 F.3d 1132, 1138 (Fed. Cir. 2007) (internal
`
`citations omitted). In this case, while the specification language repeatedly mentions soluble”
`
`signals, it also contains a definition, which does not limit the signaling moiety to a soluble
`
`

`
`
`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 17 of 40 PageID #: 26065
`Case 1:12—cv—OO104—LPS Document 181 Filed 07/07/15 Page 17 of 40 Page|D #: 26065
`
`claims. (See D.I. D.I. 161-66 Ex. B-5 at ENZO-0018106) Claims 66 and 67 contain
`
`limitations requiring the signaling moiety to be “quantifiable in or from a fluid or solution,”
`
`which would be redundant if signaling moiety were limited to soluble signals.
`
`6.
`
`“double-stranded”
`
`Plaintifl‘s Proposal:
`
`No construction necessary.
`
`Or in the alternative:
`
`two nucleic acid strands hybridized to each other
`
`
`
`Defendants ’ Proposal:
`
`two nucleic-acid strands hybridized to each other throughout
`their entire length
`
`Court’s Construction:
`
`two nucleic acid strands hybridized to each other
`
`The parties dispute whether the individual strands of the “double-stranded” nucleic
`
`acid need to be “hybridized to each other throughout their entire length.” Defendants contend
`
`that Enzo disavowed any partial double-strandedness during prosecution, so this claim term
`
`must be construed to mean that the two nucleic acid strands cannot be hybridized along just a
`
`portion of the entire length. Enzo responds that the amendments removing partial double-
`
`
`
`strandedness claims advanced the prosecution of the claims but do not constitute a disclaimer
`
`of claim scope.
`
`The doctrine of prosecution history disclaimer applies to unambiguous disavowals.
`
`See Grober v. Mako Prods., Inc., 686 F.3d 1335, 1341 (Fed. Cir. 2012) (“When a patentee
`
`makes a ‘clear and unmistakable disavowal of scope during prosecution,’ a claim’s scope may
`
`be narrowed under the doctrine of prosecution disclaimer”). The burden of demonstrating
`
`such a disclaimer is a heavy one.
`
`Here, the Examiner stated that “double-stranded lacks any specificity such as partial
`
`character for this limitation.” (D.I. 161-92 Ex. B-83 at ENZO-018733) Enzo contends that it
`
`12
`
`

`
`
`Case 1:12-cv-00104-LPS Document 181 Filed 07/07/15 Page 18 of 40 PageID #: 26066
`Case 1:12—cv—OO104—LPS Document 181 Filed 07/07/15 Page 18 of 40 Page|D #: 26066
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`did not accept this position when it cancelled claims covering “partially double—stranded”
`
`nucleic acids, and that it cancelled the claims solely to advance the prosecution of the
`
`application. (See D.I. 161-92 Ex. B-84 at ENZO-0018744 (“In yet another sincere effort, this
`
`time to advance prosecution of this application by reducing or simplifying the issues for
`
`possible appeal, Applicants have canceled pending claims 718-1265.”))
`
`Defendants have not shown a clear and unmistakable disavowal. The Court has found
`
`no express statement in the prosecution history indicating why the patentee made the
`
`amendments. The uncertainty and ambiguity in the prosecution history weighs against finding
`
`a disavowal. See 01 Communique Lab., Inc. v. LogMeIn, Inc., 687 F.3d 1292, 1297 (Fed. Cir.
`
`2012) (“There is no clear and unmistakable disclaimer if a prosecution argument is subject to
`
`more than one reasonable interpretation, one of which is consistent with a proffered meaning
`
`of the disputed term.”) (internal quotation marks omitted) Defendants have failed to persuade
`
`the Court that the patentee’s tactical decision to cancel claims expressly covering partial
`
`strandedness means that the claims it was issued require the Court to construe “double
`
`stranded” in a manner that excludes partial strandedness.
`
`7.
`
`“double—stranded nucleic acid is fixed or immobilized”
`
`[and similar terms]
`
`