Friday, June 30, 2017

D. Delaware finds Enzo's US 6,992,180 invalid for lack of enablement

Genomeweb on 29 June 2017 posted:

Enzo Biochem said today [June 29] that one of its patents at the center of a long-running intellectual property dispute has been found invalid by a federal judge.

US Patent No. 6,992,180 relates to modified nucleotides for use in diagnostic and therapeutic applications. The patent is assigned to Enzo and is central to separate ongoing lawsuits between Enzo and Hologic, Gen-Probe (now part of Hologic), Roche Molecular Systems, and Becton Dickinson.

Enzo originally sued these companies and several others for allegedly infringing the '180 and other related patents. A handful of defendants settled with Enzo in recent years, while others sought to have Enzo's patents invalidated.

Enzo said today that the US District Court for the District of Delaware has granted summary judgment for the aforementioned defendants that the '180 patent is invalid for lack of enablement. However, the court also denied summary judgment that the patent is invalid for lack of written description.


Writing in 2017 U.S. Dist. LEXIS 101652, Judge Stark observed in an opinion filed on 28 June 2017:

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
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 [*8] 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.


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
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." [*11] (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)

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.

Of 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 phosphate-
modified 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)
[*16] 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."


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)

The bottom line on enablement:

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
(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)

The judge reviewed the arguments of Enzo:

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
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 Hologic's motion for summary judgment that the '180
patent is invalid for nonenablement.

Footnote 8 is of interest:

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.

Separately -->

In a 2015 decision [2015 U.S. Dist. LEXIS 87515 ], D. Delaware performed claim construction, including

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 ll. 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 permit 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 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.


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