United States District Court, D. Columbia
GLYCOBIOSCIENCES, INC., Plaintiff, Counter Defendant
(1:12-cv-01901-RDM): Jerold I. Schneider, LEAD ATTORNEY,
SCHNEIDER ROTHMAN INTELLECTUAL PROPERTY LAW GROUP PLLC, Boca
Raton, FL; Joseph Jude Zito, ZITO, TLP, Washington, DC.
INNOCUTIS HOLDINGS, LLC., DARA BIOSCIENCES, INC., Defendants,
Counter Claimants (1:12-cv-01901-RDM): Leonard R. Svensson,
LEAD ATTORNEY, PRO HAC VICE, BIRCH, STEWART, KOLASCH & BIRCH,
LLP, Falls Church, VA; Quentin Rick Corrie, LEAD ATTORNEY,
BIRCH STEWART KOLASCH & BIRCH, LLP, Falls Church, VA.
Glycobiosciences, Inc., Plaintiff (1:15cv592): Jerold I.
Schneider, SCHNEIDER ROTHMAN INTELLECTUAL PROPERTY LAW GROUP
PLLC, Boca Raton, FL.
O PINION REGARDING CLAIM CONSTRUCTION
D. MOSS, United States District Judge.
Glycobiosciences, Inc. filed this patent infringement suit
against Defendants Innocutis Holdings, LLC and Dara
Biosciences, Inc., see Dkt. 1, alleging that
Defendants indirectly or contributorily infringed U.S. Patent
No. 6,387,407 (" the '407 patent" ) by
importing, selling, or offering to sell Defendants'
BIONECT product, see Dkt. 23 ¶ ¶ 18, 25,
32, 38. Plaintiff subsequently filed a second
infringement action asserting the '407 patent against
Defendant Fidia Farmaceutici, S.p.A (" Fidia" ),
the manufacturer of BIONECT. See No. 15-592, Dkt. 1.
Given the overlap in the complaints, the Court consolidated
the cases. See June 10, 2015, Minute Order.
A determination of [patent] infringement involves a two-step
analysis. First, the claim must be properly construed to
determine its scope and meaning. Second, the claim as
properly construed must be compared to the accused device or
process." Omega Eng'g, Inc, v. Raytek
Corp., 334 F.3d 1314, 1320 (Fed. Cir. 2003) (internal
quotation marks omitted). The matter before the Court
pertains to the first step of this analysis: claim
construction. See Dkts. 48, 49, 62, 63, 70, 72. The
parties have asked the Court to construe two disputed terms
in claim 1 of the '407 patent: " nonionic
polymer" and " weight average molecular weight from
about 650,000 to about 800,000."
See '407 patent, col.16:21-36 (emphases added).
reasons given below, and upon consideration of the '407
patent, its prosecution history, the parties' briefs and
expert declarations, and the argument and testimony at the
June 10, 2015, claim construction hearing, the Court
concludes as follows:
(1) " Nonionic polymer " means a polymer
composed of macromolecules that do not contain ionic bonds,
ions, or functional groups that would ionize in aqueous
solution under conditions applicable to the production of
(2) The use of the word " about " in the
phrase " [w]eight average molecular weight from
about 650,000 to about 800,000 " is not subject
to a precise numerical definition. The meaning of the term,
moreover, turns on both (a) consideration of fair notice to
those skilled in the art regarding the scope of the claimed
invention and (b) consideration of how variations in
molecular weight affect the performance and characteristics
of the claimed invention. Considering the first factor, the
Court concludes that the word " about" cannot
admit of variations even approaching the ± 10%
figure that Plaintiff attributes to the term. The Court
accordingly recognizes a maximum possible variation in the
Court, however, reserves judgment as to whether the meaning
of " about" can be affixed with greater precision
based on the second factor. As explained below, the parties
have yet to present the Court with sufficient evidence to
permit it to assess how small variations in molecular weight
might affect the functionality of the claimed invention.
Thus, for present purposes, the Court merely concludes that
any variation in molecular weight even approaching ±
10% plainly falls beyond the scope of claim 1. In the face of
uncertainty regarding the effect of small changes in
molecular weight on the performance and characteristics of
the invention, Defendants' proposed range of variation of
no more than ± 2% might have merit, while a somewhat
wider range might be appropriate if Plaintiff can show that
such a variation would have no functional affect on the
only patent presently asserted in this litigation is
Plaintiff's '407 patent, which issued on May 14,
2002. See Dkt. 23-1. That patent is
directed to a topical-or " transdermal" -drug
delivery process. See '407 patent, col. 1:10-15.
As explained in the patent's specification, the claimed
process involves the application of a water-based gel that
may contain a therapeutic drug to the skin; the drug is
released slowly over time as the gel penetrates the tissues
beneath the skin's outer layer. See id. col.
1:10-15, col. 2:52-64; col. 3:29-46. The gel contains a blend
of two polymer components: (1) " a negatively charged
polymer material" called " hyaluronate sodium
salt," and (2) an unspecified " nonionic
polymer." Id. col. 16:26-31.
'407 patent's only independent claim, claim 1,
A process for the use of a composition as a medical device,
for drug delivery, the application of a diagnostic agent, or
the prevention of post operative adhesions, said process
comprises topically administering to a mammal an aqueous
based gelled composition containing a polymer matrix composed
of a negatively charged polymer material blended with a
nonionic polymer ;
wherein the negatively charged polymer material is
hyaluronate sodium salt; and
wherein the hyaluronate sodium salt has a weight
average molecular weight from about 650,000 to about
800,000, a sulphated ash content below about 15%, a
protein content below about 5%[,] and purity of at least
Id. col. 16:22-36 (emphases added). The parties ask
the Court to resolve the meaning of two disputed claim terms:
" nonionic polymer" and " weight average
molecular weight from about 650,000 to about 800,000."
Dkt. 61 at 1-2.
the stage for the parties' dispute, it is necessary to
review some basic chemistry. A " polymer" is "
[a] macromolecule formed by the chemical union of five or
more identical combining units called monomers."
Hawley's Condensed Chemical Dictionary 1013
(15th ed. 2007) (" Hawley's Dictionary
" ); see also Dkt. 42-1 at 3 (Kolbert (I) Decl.
¶ 10); Transcript of Claim Construction Hearing at 82-83
(" Markman Hearing" ). The monomers are
connected together in long, bead-like chains that are often
made up of thousands of monomers. See Hawley's
Dictionary at 1013; see also Transcript of
Technology Hearing (" Tech. Hearing" ) at 24. The
physical characteristics of a polymer are often dependent on
the length of these chains. Dkt. 42-1 at 3 (Kolbert Decl. (I)
the number of monomers in a polymer can vary, and this
variation may affect the characteristics of the polymer, it
can be important to specify its size, or " molecular
weight." Dkt. 63-7 at 2 (Ex. F). As with other
polymers, " many of the biological functions of
[hyaluronic acid] are dependent on molecular size," Dkt.
63-8 at 2 (Ex. G), which explains why-as here-" the
molecular weight of [hyaluronic acid] is a primary criterion
in patents describing [hyaluronic acid] production,"
Dkt. 63-7 at 2 (Ex. F at 2759). Generally speaking, changes
in the molecular weight of hyaluronic acid affect its
viscosity-its ability to flow. Markman Hearing at
are several ways to calculate molecular weight, see
Dkt. 63-12 at 2-3 (Ex. K), which is measured in Daltons-a unit
of mass equal to one-twelfth " the mass of a free carbon
12 atom, at rest and in its ground state." Nat'l
Institute of Standards & Tech., NIST Special Publ'n No.
330, The International System of Units (SI) 34
(Barry N. Taylor & Ambler Thompson eds., 2008). The parties
do not dispute, however, that " weight average molecular
weight," measured in Daltons, is the relevant measure
with respect to the construction of claim 1 of the '407
patent. See Dkt. 61 at 2. The " weight average
molecular weight" of a polymer is calculated in a manner
that accounts for variation in size between the individual
molecules in a sample. See Dkt. 63-12 at 3 (Ex. K).
It is a method of calculating the weight of a polymer "
by taking all the different-sized molecules in the mix that
makes up [the polymer] and calculating their average weight
while giving heavier molecules a weight-related bonus when
doing so." Teva Pharms. USA, Inc. v. Sandoz,
Inc., 135 S.Ct. 831, 836, 190 L.Ed.2d 719 (2015).
like other molecules, contain chemical bonds. The monomers in
a polymer are linked together by " covalent" bonds,
Markman Hearing at 81-82, that is, bonds in which
electrons are shared between two atoms, Hawley's
Dictionary at 342. Polymers may also contain "
ionic" bonds, which are bonds created by " the
force of attraction between oppositely charged" ions.
Dkt. 63-3 at 6 (Ex. B). An ion is " [a]n atom or
radical that has lost or gained one or more electrons and has
thus acquired an electric charge." Hawley's
Dictionary at 697. In short, an atom that loses an
electron has more protons than electrons, and accordingly
becomes a positively charged ion, which is called a cation.
Dkt. 63-3 at 6 (Ex. B at 11); see also T.R. Dickson,
Introduction to Chemistry 254 (8th ed. 2000)
(Dickson, Intro to Chemistry ). An atom that gains
an electron has more electrons than protons, and thus becomes
a negatively charged ion, which is called an anion. Dkt. 63-3
at 6 (Ex. B at 11); Dickson, Intro to Chemistry, at
254. An ionic bond occurs when one molecule transfers an
electron to another molecule, forming oppositely charged ions
that are attracted to each other. See Hawley's
Dictionary at 697; Dkt. 63-3 at 6 (Ex. B at 11). By
contrast, the bonded molecules in a covalent bond share,
rather than transfer, electrons between them. See
Hawley's Dictionary at 342. Covalent bonding occurs
between molecules that are not ionized; they do not depend on
the loss or gain of an electron to form a bond. See
Dickson, Intro to Chemistry at 258-59. Rather,
" [t]he result of [a covalent bond] is that both atoms
attain a stable electronic configuration by mutual possession
of electrons." Id. at 259.
acid, a polymer used to prepare the gel composition described
in the '407 patent, is derived from " various tissue
sources including umbilical cords, skin, vitreous humour,
synovial fluid, tumors, haemolytic streptocci pigskin,
rooster combs, and the walls of veins and arteries."
'407 patent col. 4:33-35. It can also be "
synthesized artificially and by recombinant technology."
Id. col. 4:36-37. It is soluble in water and able to
form a gel matrix to which drugs that are dissolved or
disbursed in water may be added. Id. col. 4:23;
id. col. 5:56-57.
particular relevance here, the parties agree that "
hyaluronate sodium salt" -the salt form of hyaluronic
acid-contains ionic bonds. See Dkt. 70 at 9; Dkt. 72
at 11. The parties also agree that hyaluronic acid itself
does not contain ionic bonds before it is in solution.
See Dkt. 70 at 9; Dkt. 72 at 11; Markman
Hearing at 39. Hyaluronic acid does, however, contain
ionizable " carboxyl" or " -COOH" acid
functional groups that consist of carbon, oxygen, and
hydrogen atoms. Dkt. 70 at 8; Tech. Hearing at 27-29. As
relevant here, when hyaluronic acid is placed into an aqueous
solution containing sodium hydroxide, a process known as
neutralization, the carboxyl groups lose hydrogen ions
(protons), leaving oxygen atoms from the carboxyl group
negatively charged. Tech. Hearing at 27-29; see also
Michael Munowitz, Principles of Chemistry 284 (1st
ed. 2000) (explaining carboxylic acid functional groups);
Hawley's Dictionary at 1054 (defining "
proton" ). The negatively charged oxygen ions then form
ionic bonds with the positively charged sodium ions from the
ionized sodium hydroxide, forming hyaluronate sodium salt
(and water). Tech. Hearing at 27-29. To summarize, hyaluronic
acid does not contain ionic bonds, but when placed
in an aqueous solution, hyaluronic acid ionizes -it
dissociates into ions that are then attracted to
oppositely charged ions, resulting in ionic bonds. As
relevant here, those bonds are formed with sodium cations,
creating hyaluronate sodium salt.
'407 patent claims a process for the use of " an
aqueous based gelled composition containing a polymer matrix
composed of" hyaluronate sodium salt " blended with
a nonionic polymer." Col. 16:25-31. The hyaluronate
sodium salt, moreover, must have a weight average molecular
weight of between " about 650,000 to about 800,000"
Daltons. Id. col. 16:32-34.
February 20, 2015, the parties filed their opening claim
construction briefs addressing the meaning of (1) "
nonionic polymer" and (2) " a weight average
molecular weight from about 650,000 to about 800,000."
See Dkts. 48, 49. Pursuant to the Court's May 1,
2015, Minute Order, the parties subsequently filed a Joint
Claim Construction Statement to identify the disputed terms
and proposed constructions. See Dkt. 61. They then
filed responsive claim construction briefs on May 20, 2015.
See Dkts. 62, 63. On May 29, 2015, the parties
presented a technology tutorial to the Court, and, on June
10, 2015, the Court held a claim construction-or "
Markman " -hearing. At the hearing, Defendants
offered the testimony of their expert, Dr. Jason Burdick.
Plaintiff offered no expert testimony at the hearing.
claim construction hearing, Plaintiff conceded that dependent
claim 2 is indefinite because it does not contain any
limitation that is narrower than independent claim 1.
Markman Hearing at 24-25. At the hearing, Plaintiff
also conceded that dependent claim 3 " may be
redundant" and failed to identify any way in which the
subject matter covered by that claim differs from the subject
matter covered by independent claim 1. Markman
Hearing at 24. The Court, accordingly, does not address
claims 2 or 3 in this order. In addition, on the same day as
the Markman hearing, the Court consolidated
Plaintiff's infringement action against Innocutis
Holdings, LLC and Dara Biosciences, Inc., No. 12-cv-1901,
with its later-filed action against Fidia, No. 15-cv-0592.
The parties agree that the Court's ruling on claim
construction will bind Fidia, as well as the previously named
Defendants. Dkt. 69 at 2 (Defendants); Markman
Hearing at 25-26 (Plaintiff).
the hearing, Plaintiff filed a motion to strike portions of
Defendants' claim construction submissions, or for
alternative relief. See Dkt. 66. The Court denied
the motion for failure to comply with Local Civil Rule 7(m)
and directed the parties jointly to propose a schedule for
the submission of reply briefs addressing any remaining claim
construction disputes. See June 22, 2015, Minute
Order; see also Dkt. 68 (Joint Stipulation); June
23, 2015, Minute Order. Plaintiff filed its reply on June 30,
3015, see Dkt. 70, and Defendants filed their reply
on July 8, 2015, see Dkt. 72.
construction of the disputed terms of the claim, accordingly,
is now ripe for decision.
'[T]he construction of a patent, including terms of art
within its claim,' is not for a jury but
'exclusively' for 'the court' to determine .
. . even where the construction of a term of art has
'evidentiary underpinnings.'" Teva, 135
S.Ct. at 835 (quoting Markman v. Westview Instruments,
Inc., 517 U.S. 370, 372, 390, 116 S.Ct. 1384, 134
L.Ed.2d 577 (1996)). In this limited respect, the
construction of a patent is " much the same task as the
judge would [conduct] in construing other written
instruments, such as deeds, contracts, or tariffs."
Id. at 837. " [T]he ultimate issue of the
proper construction of a claim should be treated as a
question of law," but " subsidiary factfinding is
sometimes necessary." Id. at 838.
construing a patent, the court considers both intrinsic and
extrinsic evidence. The first category, intrinsic evidence,
includes the claim language itself, the specification, and
the prosecution history of the patent. " [T]he claims
are 'of primary importance'" because they "
'ascertain precisely what it is that is
patented.'" Phillips v. AWH Corp., 415 F.3d
1303, 1312 (Fed. Cir. 2005) (quoting Merrill v.
Yeomans, 94 U.S. 568, 570, 24 L.Ed. 235, 1877 Dec.
Comm'r Pat. 279 (1876)). When the court construes the
language of a claim, words are given " the ordinary and
customary 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 1313. In turn,
" the person of ordinary skill in the art is deemed to
read the claim term not only in the context of the particular
claim in which the disputed term appears, but in the context
of the entire patent . . . ." Id. This context
includes the patent specification, which is the statutorily
required " written description of the invention, and of
the manner and process of making and using it" in "
full, clear, concise, and exact terms," such that "
any person skilled in the art" could make and use the
invention. 35 U.S.C. § 112(a). Other than the language
of the claim itself, the specification " 'is the
single best guide to the ...