Enzo Life Sciences Inc. v. Gen-Probe Incorporated

Filing 284

MEMORANDUM OPINION re pending motions. Signed by Judge Leonard P. Stark on 6/28/17.This order has been emailed to local counsel. Associated Cases: 1:12-cv-00104-LPS, 1:12-cv-00106-LPS, 1:12-cv-00275-LPS, 1:12-cv-00276-LPS(etg) Modified on 6/30/2017 (ntl). (Main Document 284 replaced on 6/30/2017) (ntl).

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
ENZO LIFE SCIENCES, INC.,
Plaintiff.

v.
GEN-PROBE INCORPORATED
Defendant.

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ENZO LIFE SCIENCES, INC.,

C.A. No. 12-104-LPS

UNSEALED ON
JUNE 30, 2017
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I.

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Plaintiff;

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v.

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ROCHE MOLECULAR SYSTEMS, INC.;
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ROCHE DIAGNOSTICS CORPORATION;
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ROCHE DIAGNOSTICS OPERATIONS, INC.; . · )
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and ROCHE NIMBLEGEN, INC.
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Defendants.

ENZO LIFE SCIENCES, INC.,
Plaintiff.

v.

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BECTON, DICKINSON AND COMPANY;.
BECTON DICKINSON DIAGNOSTICS INC.;
and GENOHM SCIENCES, INC.
Defendants.

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C.A. No. 12-275-LPS
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ENZO LIFE SCIENCES, INC.,
Plaintiff.
v.
HOLOGIC, INC.,
Defendant.

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C.A. No. 12-276-LPS

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.
Karen L. Pascale, Pilar G. Kraman, YOUNG CONAWAY STARGATT & TAYLOR LLP,
Wilmington, DE
Matthew M. Wolf, ARNOLD & PORTER KAYE SCHOLER LLP, Washington, DC
Jennifer Sklenar, Wallace Wu, Marty Koresawa, ARNOLD & PORTER KAYE SCHOLER LLP,
Los Angeles, CA
Attorneys for Defendants Hologic, Inc., and Gen-Probe Incorporated
Frederick L. Cottrell, III, Katharine L. Mowery, Nicole K. Pedi, RICHARDS, LAYTON &
FJNGER, P.A., Wilmington, DE
William G. McElwain, Jamie T. Wisz, Heather M. Petruzzi, WILMER CUTLER PICKERING
HALE AND DORR LLP, Washington, DC
Robert J. Gunther, Jr., Christopher R. Noyes, Omar A., Khan, Jonathan E. Barbee, Jeffrey
Coleman, WILMER CUTLER PICKERING HALE AND DORR LLP, New York, NY
Jason H. Liss, Michael R. Heyison, WILMER CUTLER PICKERING HALE AND DORR LLP,
Boston, MA
William W. Kim, Nancy L. Schroeder, WILMER CUTLER PICKERING HALE AND DORR
LLP, Palo Alto, CA
Attorneys for Defendants Becton, Dickinson and Company; Becton Dickinson
Diagnostics Inc.; Geneohm .Sciences, Inc.; Roche Molecular Systems, Inc.; Roche
Diagnostics Operations, Inc.; Roche Diagnostics Corporation; and Roche NimbleGen,
Inc.

MEMORANDUM OPINION

June 28, 2017
Wilmington, Delaware

STARK, U.S. District Judge:
Pending before the Court are: (i) Defendants Gen-Probe Inc. ("Gen-Probe"); Roche
Molecular Systems, Inc, Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc.,
and Roche Nimblegen, Inc. (collectively, "Roche"); Becton, Dickinson and Company, Becton
Dickinson Diagnostics Inc., and Geneohm Sciences, Inc. (collectively, "BD"); and Hologic,
Inc.'s ("Hologic," and collectively, with Gen-Probe, Roche, and BD, "Defendants") Motion for
Summary Judgment oflnvalidity of U.S. Patent No. 6,992,180 (the'" 180 patent") for Failure to
Comply with the Written Description Requirement (C.A. No. 12-104-LPS D.I. 227), 1 and
(ii) Gen-Probe' s and Hologic' s Motion for Summary Judgment of Invalidity of the '180 Patent
for Nonenablement (D.I. 221).
For the reasons set forth below, the Court will deny Defendants' motion with respect to
the written description requirement and will grant Gen-Probe's and Hologic's motion with
respect to nonenablement.
I.

BACKGROUND
Plaintiff Enzo Life Sciences, Inc. ("Plaintiff' or "Enzo") filed patent infringement actions

against Defendants, alleging infringement of the' 180 patent as well as U.S. Patent No. 7,064,197
("the '197 patent"). "The '180 patent generally relates to non-radioactive nucleic acid detection
technology," while "[t)he '197 patent generally relates to nucleic acid hybridization technology
involving non-porous solid supports." (C.A. No. 12-106-LPS D.I. 260 at 3)
The '180 patent, which is the subject of the pending motions, was issued on January 31,
2006 and claims priority to June 23, 1982. (D.I. 24 7 at 3) Defendants' motions focus on

'Unless otherwise noted, all citations to the docket are to C.A. No. 12-104-LPS.
1

representative claim 1 of the '180 patent, which states, in relevant part:
An oligo- or polynucleotide which is complementary to a nucleic
acid of interest or a portion thereof, said oligo- or polynucleotide
comprising at least one modified nucleotide or modified nucleotide
analog having the formula

Sig-PM-SM-BASE
wherein ... said Sig comprises a non-polypeptide, non-nucleotidyl,
non-radioactive label moiety which can be directly or indirectly
detected when attached to PM or when said modified nucleotide is
incorporated into said oligo- or polynucleotide or when said oligoor polynucleotide is hybridized to said complementary nucleic acid
of interest or a portion thereof, and wherein Sig comprises biotin,
iminobiotin, an electron dense component, a magnetic component,
a metal-containing component, a fluorescent component, a
chemiluminescent component, a chromogenic component, a hapten
or a combination of any of the foregoing.
'180 patent col. 5911. 62-67, col. 6011. 1-21. 2
On December 15, 2016, Defendants moved for summary judgment of invalidity of the
'180 patent for lack of written description (D.I. 227) and enablement (D.I. 221). Enzo filed its
briefs in opposition to Defendants' motions on February 16, 2017 (D.I. 251 (written description),
D.I. 247 (enablement)), and Defendants filed their reply briefs on March 20, 2017 (D.I. 269
(written description), D.I. 266 (enablement)). The Court heard oral argument on both motions on
April 4, 2017. (See Transcript ("Tr.")) 3

2

All asserted claims include, or depend from claims that include, the pertinent limitations
in representative claim 1. (See D.I. 228 at 7 n.6)
3

The Court heard argument at the same time on the parties' other motions, which will be
resolved by separate opinion(s).
2

II.

LEGAL STAND ARDS
A.

Summary Judgment

Under Rule 56(a) of the Federal Rules of Civil Procedure, "[t]he court shall grant
summary judgment if the movant shows that there is no genuine dispute as to any material fact
and the movant is entitled to judgment as a matter oflaw." The moving party bears the burden of
demonstrating the absence of a genuine issue of material fact. See Matsushita Elec. Indus. Co.,

Ltd. v. Zenith Radio Corp., 475 U.S. 574, 585-86 (1986). An assertion that a fact cannot be - or,
alternatively, is - genuinely disputed must be supported either by "citing to particular parts of
materials in the record, including depositions, documents, electronically stored information,
affidavits or declarations, stipulations (including those made for purposes of the motion only),
admissions, interrogatory answers, or other materials," or by "showing that the materials cited do
not establish the absence or presence of a genuine dispute, or that an adverse party cannot
produce admissible evidence to support the fact." Fed. R. Civ. P. 56(c)(l)(A) & (B). If the
moving party has carried its burden, the nonmovant must then "come forward with specific facts
showing that there is a genuine issue for trial." Matsushita, 475 U.S. at 587 (internal quotation
marks omitted). The Court will "draw all reasonable inferences in favor of the nonmoving party,
and it may not make credibility determinations or weigh the evidence." Reeves v. Sanderson

Plumbing Prods., Inc., 530 U.S. 133, 150 (2000).
To defeat a motion for summary judgment, the nonmoving party must "do more than
simply show that there is some metaphysical doubt as to the material facts." Matsushita, 475
U.S. at 586; see also Podobnik v. US. Postal Serv., 409 F.3d 584, 594 (3d Cir. 2005) (stating
party opposing summary judgment "must present more than just bare assertions, conclusory

3

allegations or suspicions to show the existence of a genuine issue") (internal quotation marks
omitted). The "mere existence of some alleged factual dispute between the parties will not defeat
an otherwise properly supported motion for summary judgment;" a factual dispute is genuine
only where "the evidence is such that a reasonable jury could return a verdict for the nonmoving
party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986). "If the evidence is merely
colorable, or is not significantly probative, summary judgment may be granted." Id. at 249-50
(internal citations omitted); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986) (stating
entry of summary judgment is mandated "against a party who fails to make a showing sufficient
to establish the existence of an element essential to that party's case, and on which that party will
bear the burden of proof at trial"). Thus, the "mere existence of a scintilla of evidence" in
support of the nonmoving party's position is insufficient to defeat a motion for summary
judgment; there must be "evidence on which the jury could reasonably find" for the nonmoving
party. Anderson, 477 U.S. at 252.

B.

Patent Validity Under 35 U.S.C. § 112

Paragraph 1 of 35 U.S.C. § 1124 states in pertinent part:
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 ....
The statute sets out separate requirements for written description and enablement. See

4

The patent statute was amended in September 2011 by the America Invents 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.
4

Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1344 (Fed. Cir. 2010) (holding that written

description and enablement requirements are separate). Nonetheless, these requirements "often
rise and fall together." Id. at 1352.
1.

Written Description

Whether a specification satisfies the written description requirement is a question of fact.
See GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., 744 F.3d 725, 729 (Fed. Cir. 2014); see
also Alcon, Inc. v. Teva Pharms. USA, Inc., 664 F. Supp. 2d 443, 468 (D. Del. 2009)

("Satisfaction of the written description requirement is a fact-based inquiry, depending on 'the
nature of the claimed invention and the knowledge of one skilled in the art at the time an
invention is made and a patent application is filed."') (quoting Carnegie Mellon Univ. v.
Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008)). Despite being a question of

fact, the issue of invalidity for lack of written description can be amenable to summary judgment.
See, e.g., Carnegie Mellon, 541 F.3d at 1126-28 (affirming summary judgment of invalidity for

lack of written description); see also Helicos Biosciences Corp. v. Illumina, Inc., 888 F. Supp. 2d
519, 530-31 (D. Del. 2012) ("While compliance with the written description requirement is a
question of fact, the issue is 'amenable to summary judgment in cases where no reasonable fact
finder could return a verdict for the non-moving party.'") (quoting PowerOasis, Inc. v. T-Mobile
USA, Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008)).

To comply with the written description requirement, a patent's specification "must clearly
allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed."
Ariad, 598 F .3d at 1351 (internal brackets and quotation marks omitted). "[T]he test for

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
date." Id. "[T]he hallmark of written description is disclosure. Thus, 'possession as shown in
the disclosure' is a more complete formulation" of the written description requirement. Id.
"[T]he test requires an objective inquiry into the four comers of the specification from the
perspective of a person of ordinary skill in the art." Id. "[T]he written description requirement
does not demand either examples or an actual reduction to practice; a constructive reduction to
practice that in a definite way identifies the claimed invention can satisfy the written description
requirement." Id. at 1352. However, "a description that merely renders the invention obvious
does not satisfy the requirement." Id.

2.

Enablement

"Enablement is a question of law based on underlying factual findings." MagSil Corp. v.
Hitachi Glob. Storage Techs., Inc., 687 F.3d 1377, 1380 (Fed. Cir. 2012). "To be enabling, the

specification of a patent must teach those skilled in the art how to make and use the full scope of
the claimed invention without undue experimentation." Id. (internal quotation marks omitted).
"Enablement serves the dual function in the patent system of ensuring adequate disclosure of the
claimed invention and of preventing claims broader than the disclosed invention." Id. at
13 80-81. "Thus, a patentee chooses broad claim language at the peril of losing any claim that
cannot be enabled across its full scope of coverage." Id. at 1381. "The scope of the claims must
be less than or equal to the scope of the enablement to ensure that the public knowledge is
enriched by the patent specification to a degree at least commensurate with the scope of the
claims." Id. (internal quotation marks omitted).
"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
F.2d 731, 737 (Fed. Cir. 1988). These factors include "(1) the quantity of experimentation
necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative
skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of
the claims." Id. Although "a specification need not disclose what is well known in the art,"
"[t]ossing out the mere germ of an idea does not constitute enabling disclosure." Genentech, 108
F .3d at 1366. A patent "cannot simply rely on the knowledge of a person of ordinary skill to
serve as a substitute for the missing information in the specification." ALZA Corp. v. Andrx

Pharm., LLC, 603 F.3d 935, 941 (Fed. Cir. 2010).
III.

DISCUSSION
A.

Written Description
1.

Written Description for the Functional Limitations of Claim 1

Defendants seek summary judgment that the '180 patent lacks adequate written
description for the functional limitations of claim 1: "( 1) the labeled polynucleotide is hybridized
to a nucleic acid sequence of interest, and (2) ... the label is detectable when the labeled
polynucleotide is so hybridized." (D.1. 228 at 6) In Defendants' view, the specification does not
adequately describe these limitations because Example V - which, according to Defendants, is
"the only example anywhere in the intrinsic record that purports to describe the manufacture or
synthesis of a phosphate labeled polynucleotide" - "undisputed[ly] ... provides [no] description
relating to hybridization or detectability upon hybridization." (Id. at 7) Defendants further
contend that Enzo's technical expert admitted that the rest of the specification contains "no
7

example, experiment, or data ... to suggest that the product of Example V could hybridize or
that its label is detectable when hybridized." (Id. at 11; see also D.I. 229-1 Ex. 5 at 131-32)
Enzo responds that "[a] person of ordinary skill [('POSA')] would have understood" the
words "probe" and "hybridization probe" in the '180 patent specification "to (1) be capable of
hybridizing and (2) be detectable upon hybridization." (D.I. 251 at 4) In Enzo's view, a POSA
would have also understood that "hybridization and detection is the plain purpose to which
Example Vis directed." (Id. at 9) In addition to Example V, Enzo argues that the specification's
"explicit disclosures of phosphate attachment[s], labels, linkages, and exemplary chemistry for
making the labeled nucleic acids ... would have served as common structural features that
allowed [POSAs] to recognize that the inventors possessed phosphate-labeled polynucleotides
capable of hybridization and subsequent detection." (Id. at 10) At oral argument, Enzo
additionally pointed to column 54 line 18 - a portion of the specification in addition to Example
V - as supplying the method for probes that is "useful for hybridization and detection." (Tr. at
95; see also '180 patent col. 5411. 18-23 ("A particularly important and useful aspect of the
special nucleotides of this invention is the use of such nucleotides in the preparation of DNA or
RNA probes. Some probes would contain a nucleotide sequence substantially matching the
DNA or RNA sequence of genetic material to be located and/or identified."))
The record demonstrates genuine disputes of material fact with respect to whether the
'180 patent contains adequate written description to support the functional limitations of claim 1.
A reasonable jury could find, as Defendants assert, that neither Example V nor the rest of the
specification "provides any description relating to hybridization or detectability upon
hybridization." (D.I. 228 at 7) Alternatively, a reasonable jury could instead find, as Enzo
8

contends, that Example V and/or the rest of the specification would allow a POSA "to recognize
that the inventors possessed phosphate-labeled polynucleotides capable of hybridization and
subsequent detection." (D.I. 251 at 10) Hence, the record contains sufficient evidence from
which a reasonable jury could find for either Defendants or Enzo on written description with
respect to claim l's functional limitations. (See, e.g., D.I. 228 at 11; D.I. 229-1Ex.5at131-32;
D.I. 251 at 9-1 O; '180 patent col. 54 11. 18-23)
Accordingly, the Court must deny this portion of Defendants' motion for summary
judgment.

2.

Written Description for Making Internal
Phosphate-Labeled Polynucleotides

Defendants argue that the Court should grant summary judgment that the specification of
the '180 patent lacks adequate written description for "making ... internal phosphate-labeled
oligonucleotides" (D.I. 228 at 9) (emphasis omitted); that is, nucleic acids "having a label
positioned internally rather than at the end of the nucleic acid" (id. at 1). In support of their
motion, Defendants note "[i]t is undisputed that, if the synthesis scheme of Example V worked at
all, it would only succeed in attaching a biotin to [a] terminal phosphate," not an internal
phosphate. (Id. at 8) (emphasis omitted) Defendants further contend that, "[w]ith respect to
Example V, Enzo told the Patent Office that Example V resulted in a terminal label - and not an
internal label." (Id. at 13) In Defendants' view, the rest of the specification similarly lacks an
"example, experiment, or model of any specific species of [an] internal phosphate-labeled
polynucleotide." (Id.)
Enzo counters that "Example V of the '180 [p ]atent specification discloses a method that

9

attaches biotin at phosphate moieties, whether terminal or internal, by way of the amine groups
on biotinylated poly-L-lysine and biotinyl-1,6-diaminohexane." (D.I. 251 at 15; see also D.I. 252
Ex. 9 at A307 (expert testimony)) Enzo further contends that a POSA "would have been aware
of art showing how to incorporate moieties such as aryl, alkyl, and methyl phosphonates at
internal positions that would have been understood as suitable chemistry for likewise
incorporating a signaling moiety (and linkage) at internal positions." (D.I. 251at16; see also
D.I. 252-1 Ex. 38 at A807-08, 813-14) Thus, in Enzo's view, "at a minimum, a dispute of
material fact exists as to whether Example V discloses internal labeling" and whether a POSA
would have been aware of "suitable chemistry for ... incorporating a signaling moiety ... at
internal positions." (D.I. 251 at 16)
The Court agrees with Enzo that genuine disputes of material fact preclude summary
judgment on this issue. The parties disagree as to whether Example V discloses a method that
attaches biotin to internal phosphate moieties. (Compare D.I. 228 at 8, 13 with D.I. 251 at 15)
The parties further disagree on whether a POSA would have been aware of suitable chemistry for
internal labeling. (Compare D.I. 228 at 17 with D.I. 251 at 16) Both sides cite record evidence
for their contentions, including expert opinions, such that a reasonable jury could find for either
side: finding insufficient written description for internal phosphate labeling or, alternatively,
adequate written description for internal phosphate labeling. Therefore, the record demonstrates
genuine disputes of material fact with respect to whether Example V discloses internal phosphate
labeling and whether the chemistry for internal phosphate labeling was known in the art.
Accordingly, the Court must deny this portion of Defendants' motion for summary
judgment.

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B.

Enablement

Defendants Gen-Probe and Hologic (collectively, hereinafter, "Hologic") 5 request that the
Court grant summary judgment that the '180 patent is invalid for nonenablement because the
specification lacks any "meaningful disclosure ... on how to make and use the vast number of
phosphate-labeled polynucleotides covered by the asserted claims." (D.I. 222 at 7) In support of
its argument, Hologic points to the following statement in the '180 patent about a phosphatemodified nucleotide:
The special nucleotides of this invention include a phosphoric acid
P moiety (also designated hereinbelow as "PM"), a sugar or
monosaccharide S moiety (also designated hereinbelow as "SM"),
a base B moiety (also designated hereinbelow as "BASE"), a
purine or a pyrimidine and a signal[]ing chemical moiety Sig
covalently attached thereto, e[it]her to the P, Sor B moiety.
(D .I. 222 at 7) (quoting '180 patent at col. 48 11. 60-66)
Hologic argues that "[t]he above disclosure does not indicate ... any specific nucleotide,
any specific label, any specific linker, any specific position of a phosphate-modified nucleotide
within the polynucleotide, or any specific sequence of length of the polynucleotide." (D.I. 222 at
7) In Hologic's view, the rest of the specification similarly "provides no guidance on how to

select, among numerous possibilities, the sequence and length of the polynucleotide, the location
and number of internal phosphate labels, or the location and number of nucleotide analogs." (Id.
at 12)
Hologic further argues that the unpredictability in the state of the art contributes to
rendering the '180 patent invalid for nonenablement. (See id. at 8-9, 13-15) Hologic cites

5

Gen-Probe became a part ofHologic in August 2012. (D.I. 222 at 1 n.1)
11

testimony of Enzo' s expert, Dr. Backman, who opined that, as of the priority date, "it was
commonly thought that ... chemically labeling the phosphate group would interfere with
hybridization." (Id. at 8) (internal quotation marks omitted) Hologic additionally cites the
testimony of one of the '180 patent inventors, Dr. Stavrianopoulos, who acknowledged that
internal labeling "required methods and principles of organic chemistry [that were] unknown" as
of the priority date (id. at 14) and remain "difficult ... even today" (id. at 10) (internal quotation
marks omitted). In Hologic's view, making an internal-phosphate-polynucleotide would have
also required "extensive experimentation" because, while "each asserted claim covers all
polynucleotides up to 100,000 DNA nucleotides long" (id. at 6), yet "the maximum length for
chemical synthesis of a polynucleotide in 1982 was 15 nucleotides" (id. at 9) (citing Dr.
Stavrianopoulos's testimony). Furthermore, according to Hologic, "[t]he synthesis of a
polynucleotide longer than 100,000 nucleotides was not achieved until 2008." (Id.)
Enzo responds that "[t]he '180 [p]atent specification discloses signaling moieties, ...
provides several examples of chemical linkages, ... discloses exemplary lengths of the claimed
polynucleotides (e.g., 5 to 500 nucleotides), ... [a]nd ... discloses that the label is detectable."
(D.I. 247 at 7) In particular, Enzo contends that Example V "describes a method for attaching
biotin at terminal and internal phosphate moieties of DNA polynucleotides." (Id. at 7-8)
("Example V ... appl[ies] chemistry known in the art to create an embodiment of the invention")
Enzo further contends that a POSA attempting to practice the invention "would not have
considered every conceivable variation" or sequence of the claimed polynucleotide (id. at 12)
(emphasis omitted), because "the specific sequence of the claimed polynucleotide is ... no[t]
germane to the claimed inventions" (id. at 1) (emphasis omitted). Finally, in Enzo's view,

12

practicing the inventions would have required, "at most, routine [experimentation]," as the
chemistry for internal labeling "w[ as] known in the art" and a polynucleotide longer than 15
nucleotides "could be joined together through ligation." (Id. at 14-15; see also id. at 6 ("The
inventions of the '180 [p]atent ... pertain to nucleic acid hybridization and detection, which was
a decades-old field by the time of the original application for the '180 [p]atent."))
In its reply, Hologic argues that "Enzo's contention that ... claim scope is 'irrelevant' ...
turns the enablement requirement on its head," as "[t]he law makes clear that a specification must
enable the full scope of the claimed invention." (D.I. 266 at 4) (emphasis omitted) Hologic
notes that "the claims are not limited to the preferred embodiments" - but, even if they were,
"[n]othing in the [specification] teaches one how to select the length and sequence of a
polynucleotide.within the preferred 5 to 500 nucleotides or how to decide where to place the 1 to
100 phosphate-labeled nucleotides within the polynucleotide of 5-to-500 nucleotides long." (Id.
at 6-7) In Hologic's view, the specification also "fails to describe" other aspects of the invention
- for example, a "phosphate-labeled polynucleotide[] that maintain[s] hybridizability and
detectability." (Id. at 5) Hologic further argues that Example V "does not describe any actual
phosphate labeling" (id. at 1), does not disclose "the sequence or the length of the precipitated
DNA" (id. at 2), and does not "indicat[e] whether the reaction is complete or successful" (id.).
While Enzo asserts that "the missing information could be found within the knowledge of
a skilled artisan," Hologic replies that "the specification ... must supply the novel aspects of an
invention in order to constitute adequate enablement." (Id. at 5) (internal quotation marks
omitted) Moreover, even taking into account what a POSA knew at the pertinent time, that still
"fails to show any actual example of internal phosphate labeling by any method prior to June
13

1982." (Id. at 3) (discussing Dr. Backman's testimony; emphasis omitted) Finally, Hologic
disputes Enzo' s assertion that the inventions of the '180 patent pertain to a "decades-old field."
(D.I. 247 at 6) In Hologic's view, "the field of the claimed invention ... is the phosphate
labeling of a polynucleotide," which was "new" and "highly unpredictable" as of the priority
date. (D.I. 266 at 6) (citing testimony of Dr. Backman, Enzo's expert, that "[t]here was
ignorance in the art about non-radioactively labeling a nucleic acid probe ... before [the priority
date]") (internal emphasis and quotation marks omitted; first alteration in original)
"To prove that a claim is invalid for lack of enablement, a challenger must show by clear
and convincing evidence that a person of ordinary skill in the art would not be able to practice the
claimed invention without 'undue experimentation."' Alcon Research Ltd. v. Barr Labs., Inc.,
745 F.3d 1180, 188 (Fed. Cir. 2014) (quoting Wands, 858 F.2d at 736-37). The Court finds that
there is no genuine dispute of fact that the '180 patent specification lacks enablement. A
reasonable jury simply could not find for Enzo. Instead, the only conclusion a reasonable jury
could reach is that clear and convincing evidence proves the '180 patent is invalid for
noneablement.
"[T]he specification must teach those of skill in the art how to make and how to use the
invention as broadly as it is claimed." In re Goodman, l l F.3d 1046, 1050 (Fed. Cir. 1993)
(internal quotation marks omitted; emphasis added). Here, the claims are extremely broad. Even
limiting claim scope to the preferred embodiments (for argument's sake), Hologic correctly
points out that the specification does not teach "one how to select the length and sequence of a
polynucleotide within the preferred 5 to 500 nucleotides or how to decide where to place the 1 to
100 phosphate-labeled nucleotides within the polynucleotide of 5-to-500 nucleotides long." (D.I.
14

266 at 7) Moreover, even if the Court accepts Enzo's contentions that Example V discloses
internal labeling and that "[t]he inventions of the '180 patent ... pertain to ... hybridization and
detection" (D.I. 247 at 6), neither Example V nor other parts of the specification indicates
whether an internal phosphate-labeled polynucleotide "maintain[ s] hybridizability and
detectability" (D.I. 266 at 5; see also generally Genentech, Inc. v. Novo NordiskAIS, 108 F.3d
1361, 1366 (Fed. Cir. 1997) ("Patent protection is granted in return for an enabling disclosure of
an invention, not for vague intimations of general ideas that may or may not be workable.")) As
such, again as Hologic explains, a POSA "would have no choice but to make and test a vast
number of possible variants to the claimed invention." (D.I. 266 at 7) That is, undue
experimentation would be required, rendering the claims non-enabled.
The Court agrees with Hologic's comparison of the present situation to that confronted by
the Federal Circuit in Wyeth v. Abbott Laboratories, 720 F.3d 1380 (Fed. Cir. 2013). In Wyeth,
the Federal Circuit affirmed a grant of summary judgment based on nonenablement. See id. at
1386. Here, "(l) the claims are far broader than in Wyeth,[ 6 ] (2) the disclosures here are far less
than in Wyeth,[7] (3) the relevant field is even more unpredictable than in Wyeth, and (4) the trialand-error process would have taken even longer than in Wyeth." (D.I. 266 at 4) It follows that,
here, as in Wyeth, there is no genuine dispute that the claims are invalid due to nonenablement.
This same conclusion is supported by consideration of the Wands factors. See 858 F.2d at

6

As Hologic argues, the "millions (or more) of phosphate-labeled polynucleotides with
varying sequences and lengths covered by each asserted claim of the '180 patent far exceed the
tens of thousands ofsirolimus analogs in Wyeth." (D.I. 222 at 11)
7

As Hologic argues, "[w]hile the specification in Wyeth disclosed at least one working
example of the claimed invention (sirolimus), the '180 patent discloses none." (D.I. 222 at 12)
15

73 7. Based on the record, a reasonable factfinder could only find: ( 1) the quantity of
experimentation necessary to arrive at embodiments equal to the full scope of the claims is
undue; (2) insufficient direction or guidance is presented in the patent to allow a POSA to avoid
undue experimentation; (3) insufficient working examples are present; 8 (4) the invention arises in
a field of art that was highly unpredictable at the time of the invention; (5) the prior art showed
that the pertinent field was unpredictable; (6) even though the relative skill of those in the art was
high, POSAs at the time did not have sufficient knowledge to "fill in" all that is missing from the
patent; (7) the art was, as already noted, highly unpredictable; and (8) the claims are extremely
broad. (See D.I. 223-1 Ex. 1iii!503-33)
Enzo opposes this conclusion, arguing that "chemistries ... known in the art at the
relevant time ... could have been used to create a polynucleotide" that meets claim 1's
limitations. (D.I. 247 at 14) Enzo's argument, however, "ignore[s] the essence of the
enablement requirement." Genentech, 108 F.3d at 1366. "It is the specification, not the
knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to
constitute adequate enablement." Id. "[W]hen there is no disclosure of any specific starting
material or of any of the conditions under which a process can be carried out, undue
experimentation is required." Id. Thus, Enzo' s references as to what "wa[ s] known in the art"
(D.I. 247 at 14) are unavailing; "a failure to meet the enablement requirement ... cannot be

8

Enzo admitted during prosecution of the '180 patent that Example V is a '"paper,' rather
than 'working example[] .... "' (D.I. 223-3 Ex. 17 at ENZ0-0096256) In this litigation, Enzo
attempts to create a dispute of fact by pointing to testimony that one inventor has some
recollection of Example V being performed "around '82, I don't remember that now." (D.1. 250
at A294) Even assuming a reasonable finder of fact could conclude, on this record, that some
version of Example V was carried out by the inventors, the overall record remains one on which
a reasonable finder of fact could only find that the claims are not enabled.
16

rectified by asserting that all the disclosure related to the process is within the skill of the art,"
Genentech, 108 F.3d at 1366. 9

Accordingly, the Court will grant Ho logic's motion for summary judgment that the '180
patent is invalid for nonenablement. 10

IV.

CONCLUSION
For the foregoing reasons, the Court will deny Defendants' motion with respect to the

written description requirement and will grant Hologic' s motion with respect to nonenablement.
An appropriate Order follows.

9

Additionally, even if the Court were to consider Enzo's assertions as to the state of the
art at the priority date, the record indisputably establishes that "there was ignorance in the art
about non-radioactively labeling a nucleic acid probe (including non-radioactively labeling any
oligo- or polynucleotide in a probe) at a phosphate moiety before June 23, 1982." (D.I. 267-1
Ex. 30 at 20) (emphasis added) Enzo's assertions, therefore, do not conclusively establish that
the relevant chemistries were "well known in the art" at the time the '180 patent was filed.
Genentech, 108 F.3d at 1366.
10

The Court recognizes that, during prosecution, Enzo overcame a nonenablement
rejection. (See D.I. 247 at 3-4) (citing D.I. 250-1 at A583-623, 636-49, 651-58, 660-66, 668-75,
677-83, 685-91, 693-775, 777-84, 786-802, 804-23) However, as Hologic aptly observes, "the
Examiner only considered Enzo' s argument and was not presented with the overwhelming
evidence of nonenablement set forth in Defendants' summary judgment briefing." (D.I. 266 at 4
n.4)
17