United States District Court, D. Delaware
CLAIM CONSTRUCTION OPINION
RICHARD A. LLORET U.S. MAGISTRATE JUDGE
Hakko Bio, Co., Ltd. and related companies
(“Plaintiffs, ” or “Kyowa”) filed a
complaint claiming that Ajinomoto Co. Ltd. and related
companies (“Defendants, ” or
“Ajinomoto”) infringe their U.S. Patent No. 45,
723 (“the ‘723 patent” or
“'723”) by making amino acids by a
method claimed in the ‘723 patent. Docket
Item (“D.I.”) 1, ¶ 1-2. The case has been
referred to me for claim construction under Markman v.
Westview Instruments, Inc., 517 U.S. 370 (1996). D.I.
76. The parties have briefed the issues thoroughly, and I
held oral argument on July 29, 2019. This opinion construes
the disputed claim language.
claims of a patent define the invention to which the patentee
is entitled the right to exclude.” Eli Lilly and
Company v. Eagle Pharmaceuticals, Inc., 2019 WL 1299212,
at *1 (D.Del. 2019) (quoting Innova/Pure Water, Inc. v.
Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115
(Fed. Cir. 2004)). Claim construction is a question of law.
Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct.
831, 837 (2015). Claim terms generally are given “the
meaning that the term would have to a person of ordinary
skill in the art in question at the time of the
invention.” Phillips v. AWH Corp., 415 F.3d
1303, 1313 (Fed. Cir. 2005) (quoted in Eli Lilly,
2019 WL 1299212, at *1). This general rule gives way when the
patentee sets out a defined term in the patent, or disavows
the full scope of the term's ordinary meaning, either in
the specification or during prosecution. Unwired Planet,
LLC v. Apple Inc., 829 F.3d 1353, 1358 (Fed. Cir. 2016).
look for a term's ordinary meaning in the
“intrinsic evidence, ” which is the claim
language, the specification, and the prosecution history.
Leseman, LLC v. Stratasys, Inc., 730 Fed.Appx. 912,
914 (Fed. Cir. 2018). If necessary, a court may also look to
“extrinsic evidence, ” which includes
“expert and inventor testimony, dictionaries, and
learned treatises.” Markman v. Westview
Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995).
Extrinsic evidence may not be used “for the purpose of
varying or contradicting the terms of the claims.”
Markman, 52 F.3d at 981. “The 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).
acids are mass produced by fermentation. Declaration of Dr.
Michael F. Doherty (“Doherty”), D.I. 84, at
¶¶16-18; Declaration of Dr. Allen S. Myerson
(“Myerson”), D.I. 85, at ¶¶1-15.
Fermentation is a process that uses microorganisms (often
bacteria) to produce a chemical. Id. The bacteria
are placed in a fermentation broth, also called a culture, in
which the bacteria grow, releasing amino acids into the broth
as a by-product. Id. The amino acids eventually
crystalize and can then be separated from the bacteria in the
broth. '723 patent at 1:18-41.
broth becomes more and more concentrated as the bacteria
produces amino acids, until the broth reaches a point called
saturation, which means that under the existing conditions
the broth cannot hold any more dissolved amino acid. Doherty
at ¶¶18 -19; Myerson at ¶15. If more amino
acid is added to a saturated solution it becomes
“supersaturated.” Id. In a
supersaturated solution, the amino acids precipitate
(“nucleate out”) and begin to form crystals.
Doherty at ¶¶18 -19; Myerson at ¶¶15-16.
crystal particles into the broth can change the growth
pattern of amino acid crystals. The amino acids latch onto
the seed crystals and grow larger crystal particles than they
would if nucleated out on their own. Myerson at ¶16.
These larger crystals can then be more easily harvested from
the broth. Doherty at ¶¶20-21. Seed crystals of the
desired size can be introduced into the broth directly, or by
different types of agitation, shock, friction, and pressure.
Doherty at ¶23-25.
of the ‘723 patent (referred to as “Claim
1”) describes a process for efficiently growing amino
acid crystals in an amino acid broth by adding
(“seeding”) amino acid crystals of a particular
average size to the broth at a particular time in the brewing
process. D.I. 1, ¶56. Claim 1 measures the results of
the process by the concentration of the crystals produced.
Id. Claim 2 of the ‘723 patent adopts the
process in Claim 1, but measures the results differently.
Id., ¶57. Claims 7 and 8 are dependent on
Claims 1 and 2, respectively. Id., at ¶59. Both
Claims 1 and 2 require that added crystals be within a
specific size range, defined by their “average particle
size, ” and be added at a particular time. Pl. Br. at
of the patent reads as follows:
1. A process for producing an amino acid, which comprises:
[a] culturing a microorganism having an ability to produce
the amino acid in a medium,
[b] adding crystals of the amino acid having an average
particle size of 7 to 50 μm to the medium at some time
after the amino acid concentration in the medium reaches the
saturation solubility and before crystals of the amino acid
deposit in the medium so that the concentration of the
crystals of the amino acid becomes 0.5 g/l or more,
[c] culturing the microorganism having the ability to produce
the amino acid in the medium,
[d] allowing the crystals of the amino acid to grow to
crystals of the amino acid having an average particle size of
30 μm or more and accumulate in the medium, and
[e] recovering the crystals of the amino acid from the
culture by separating the microorganism producing the amino
acid and the accumulated crystals of the amino acid based on
the difference in particle size or specific gravity between
D.I. 1, ¶ 56. Claim 2 tracks the language of Claim 1,
but where Claim 1 requires the concentration of the crystals
to reach a certain number of grams per liter (sub-paragraph
(b)), Claim 2 requires the crystals in the medium to reach a
certain total surface area. ‘723 patent at 11:8-10.
'723 patent purported to solve some problems with then
existing methods of collecting amino acids from a broth. One
problem was that high concentration of amino acids in the
broth tended to inhibit further production of crystals.
‘723 patent at 1:31-32. Prior methods also yielded a lot
of microcrystals that were difficult to separate from the
broth because of their extremely small size. ‘723
patent at 1:42-51. Because the microcrystals were too small
to be efficiently directly removed from the medium, the prior
art required additional steps to harvest crystals, such as
adding water and heat, or using a centrifugal or filtration
separator. Id. at 1:46-51.
'723 patent overcame the problems by its crystal seeding
method. The inventors claimed that once the fermentation
broth is saturated, adding seed crystals of a size range from
7-50 microns, at a great enough concentration (0.5 grams per
liter or more), at a point in time after saturation but
before crystals deposit, provided a dispersed crystal surface
onto which amino acids will latch when forming crystals.
See Id. at 10:45-67. This method generates enough
crystals of the correct size so that the suspended amino acid
has somewhere to go once it nucleates, stimulating continued
production. See Id. at 10:12-24. It also generates
crystals large enough to be easily separated from the
microbes in the broth. See Id. at 9:17-30.
parties dispute the construction of three phrases in Claims 1
and 2: “average particle size, ” in subparagraph
[a], above, “adding crystals of the amino acid . . . to
the medium” at the beginning of subparagraph [b], and
“before crystals of the amino acid deposit in the
medium, ” at the end of subparagraph [b]. D.I. 68-1
(“Joint Claim Construction Chart” or
Average particle size.
contends that the phrase “average particle size”
means “[t]he sum of particle sizes divided by the
number of particles.” Id. at 2. Ajinomoto
argues that the phrase means “volume average diameter
(or volume mean diameter), ” or that alternatively, the
term is indefinite. Id. at 2-3.
ordinary use of the term “average” refers to a
numeric average. If I mention that the average age of federal
judges is 39 (a dubious assertion), it means to the ordinary
user of English that I have added up the ages of all federal
judges and divided that sum by the number of judges.
“Average particle size” has an ordinary English
meaning, in this sense: the size of each of the particles in
a given set, added together, and divided by the number of
particles. The question is whether this is the ordinary or
customary meaning of the phrase to the person of ordinary
skill in the art. Phillips, 415 F.3d at 1313. There
are reasons to believe that “average particle size,
” as used in the patent, could have meant either what
it would suggest to an ordinary speaker of English or a
volume weighted average diameter. To understand these
reasons, and to weigh them appropriately, it is necessary to
explain some details about measuring particles and
calculating average sizes. After doing so I will examine the
are various ways to measure particles: sieving, in which
particles are shaken over a sieve with specifically sized
holes; image analysis, in which an image of the particle is
measured against a reference scale; focused beam reflectance
measurement (“FBRM”), which measures the light
bouncing back from a laser directed into a group of
particles; laser diffraction, which measures the amount of
light scattered when a laser hits a particle; sedimentation,
which equates how long a particle takes to fall through a
known liquid to a sphere that would fall at the same rate
through the same liquid; and electrozone sensing, which
equates a particle's size to its electrical conductivity.
Pl. Br. at 5-6; Doherty at ¶27; Myerson at ¶33.
come in all kinds of shapes. The parties agree that a
standard convention used by persons of skill in the art is to
assume that the measured particle is a sphere. See
‘723 patent at 8:37-40; Doherty at ¶26;
Myerson at ¶30, 32. This convention trades precision for
the convenience of allowing practitioners to characterize
particles by one number - a diameter. Doherty at ¶26;
Myerson at ¶32-34.
Averaging the size of particles.
various sizes of a group of particles may be reported as a
curve, as in the image above. Pl. Br. at 7. Practitioners
also have developed two categories of mathematical formulae
for reporting on the size of a group of particles as a single
number: “number average” and “weighted
average.” Doherty at ¶ 38; see Myerson at
¶35. These two categories of averaging methodology have
different iterations and different statistical purposes.
Doherty at ¶¶54-71; Myerson at ¶¶33-36.
The number average category includes a “simple
average” - also called an “arithmetic mean
particle diameter” - equation: adding up the ...