Vectura Limited v. GlaxoSmithKline LLC et al

Filing 167

MEMORANDUM OPINION providing claim construction for multiple terms in U.S. Patent Nos. 8,303,991 and 8,435,567. Within five days the parties shall submit a proposed order consistent with this Memorandum Opinion. Signed by Judge Richard G. Andrews on 10/1/2018. (nms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

VECTURA LIMITED,
Plaintiff,
Civil Action No . 1: 16-cv-00638-RGA

V.

GLAXOSMITHKLINE LLC and GLAXO
GROUP LIMITED,
Defendants.

MEMORANDUM OPINION
Kelly E. Farnan, Christine D. Haynes, RICHARDS , LAYTON & FINGER, P.A. , Wilmington,
DE; Dominick A. Conde, Christopher B. Borello (argued), Brendan M. O ' Malley (argued),
Michael P. McGraw, Damien N. Dombrowski, FITZPATRICK, CELLA, HARPER & SCINTO,
New York, NY.
Attorneys for Plaintiff.
Jack B. Blumenfeld, MORRIS, NICHOLS , ARSHT & TUNNELL LLP, Wilmington, DE;
Martin J. Black, Kevin M. Flannery (argued), Robert Ashbrook, Sharon K. Gagliardi,
DECHERT, LLP, Philadelphia, PA; Blake B. Greene (argued), DECHERT LLP, Austin, TX.
Attorneys for Defendants.

_j_,2018

October

~ ~ISTRICT JUDG :
Presently before the Court is the issue of claim construction of multiple terms in U.S.
Patent Nos. 8,303 ,991 ("the ' 991 patent") and 8,435,567 ("the ' 567 patent"). The Court has
considered the Parties' Joint Claim Construction Brief. (D.I. 82). The Court heard oral
argument on May 21, 2018. (D.I. 106 ("Tr.")). The Court heard expert testimony on September
10, 2018. ("Exp. Tr." (transcript not yet docketed)).
I.

BACKGROUND
The patents-in-suit "relate to pharmaceutical compositions for inhalation and methods of

making them." (D.I. 82 at 1).
The parties originally presented claim construction disputes for U.S. Patent No.
8,956,661 ("the ' 661 patent"). (D.I. 82 at 1 n.1). However, Plaintiff has since stated that it will
not assert the ' 661 patent. (D.I. 117 at 1). Plaintiff nonetheless indicates that several terms
which appear in the ' 661 patent "may remain in the case depending on the Court's construction
of the claim terms in" the ' 991 and '567 patents. (Id. at 2).
The '991 and '661 patents share a specification, and derive from the same parent
application. (D.I. 82 at 1 n.1 ). The ' 567 patent contains a distinct specification, and derives
from a different parent application. (Id.).
Independent claim 1 of the ' 991 patent is representative, and reads as follows:
1. Composite active particles for use in a pharmaceutical composition for
pulmonary administration, each composite active particle comprising a
particle of active material and particulate additive material on the surface
of that particle of active material, wherein the composite active particles
have a mass median aerodynamic diameter of not more than 10 µm , and
wherein the additive material promotes the dispersion of the composite
active particles upon actuation of a delivery device.
('991 patent, claim 1) (disputed terms italicized). Claim 1 of the ' 567 patent is representative:

l. Microparticles for use in a pharmaceutical composition for pulmonary
administration, comprising particles of an active substance having, on
their surfaces, particles of a hy drophobic material suitable for promoting
the dispersal of the active particles on actuation of an inhaler and suitable
for delaying the dissolution of the active substance, wherein the
hydrophobic material comprises one or more materials selected from the
group consisting of hydrophobic amino acids, metal stearates, a C1 oto C22
carboxylic acid, phospholipids, and derivatives thereof.
(' 567 patent, claim 1) (disputed terms italicized).

II.

LEGAL STAND ARD
"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. AWHCorp., 415 F.3d 1303, 1312
(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). "' [T]here is no magic formula or
catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
weight to appropriate sources ' in light of the statutes and policies that inform patent law."'
SoftView LLC v. Apple Inc., 2013 WL 4758195 , at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,

415 F.3d at 1324) (alteration in original). When construing patent claims, a court considers the
literal language of the claim, the patent specification, and the prosecution history. Markman v.
Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370

(1996). Of these sources, "the 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. "
Phillips, 415 F.3d at 1315 (internal quotation marks omitted).

" [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 (citations and internal quotation marks omitted). " [T]he ordinary meaning of a

claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 132 1

2

(internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as
understood by a person of skill in the art may be readily apparent even to lay judges, and claim
construction in such cases involves little more than the application of the widely accepted
meaning of commonly understood words." Id. at 1314.
When a court relies solely upon the intrinsic evidence- the patent claims, the
specification, and the prosecution history- the court' s construction is a determination oflaw.

See Teva Pharm. USA, Inc. v. Sandoz, Inc. , 135 S. Ct. 831 , 841 (2015). The court may also
make factual findings based upon consideration of extrinsic evidence, which "consists of all
evidence external to the patent and prosecution history, including expert and inventor testimony,
dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19. Extrinsic evidence may assist
the court in understanding the underlying technology, the meaning of terms to one skilled in the
art, and how the invention works. Id. Extrinsic evidence, however, is less reliable and less
useful in claim construction than the patent and its prosecution history. Id.
"A claim construction is persuasive, not because it follows a certain rule, but because it
defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa ' p er

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) (citation omitted).

III.

TERMS FOR CONSTRUCTION

A. "composite active particle(s)" ('991) and "microparticles" ('567); "on the surface (of)"
('991) and "on their surfaces" ('567); "each composite active particle comprising a
particle of active material and particulate additive material on the surface of that
particle of active material" ('991) and "comprising particles of an active substance
having, on their surfaces, particles of a hydrophobic material" ('567) 1
1

The parties represent that some disputed terms are "subsumed within [other] terms and
proposed constructions." (D.I. 82 at 5, n.6) .
3

1. Plaintiff's proposed construction ("composite active particles '): "[a] single particulate
entit[y/ies] made up of a particle of active material to which one or more particles of
additive material are fused"
2. Plaintiff's proposed construction ("each composite active particle comprising a particle
of active material and particulate additive material on the surface of that particle of
active material "): "where a composite active material is a single particulate entity made
up of a particle of active material to which one or more particles of additive material are
fused" 2
3. Defendants ' proposed construction ("composite active particle(s) "): "particulate entities
formed by milling a uniform blend of only additive particles and active particles (with or
without liquid) using sufficient energy and duration to ensure sufficient break-up of
agglomerates of both constituents, dispersal, and even distribution of additive over the
active particles"
4. Defendants ' proposed construction ( "each composite active particle comprising a
particle of active material and particulate additive material on the surface of that
particle of active material '): "each composite active particle comprising a particle of
active material and particles of additive material irreversibly bound by fusing to the
surface of the active particle, thereby forming a continuous coating or a discontinuous
coating covering, on average, at least 50% of the total surface area of the active particles"
5. Court 's construction (" composite active particles '): "[a] single particulate entit[y/ies]
made up of a particle of active material to which one or more particles of additive
material are fixed such that the active and additive particles do not separate in the
airstream"
6. Court's construction ("each composite active particle comprising a particle of active
material and particulate additive material on the surface of that particle of active
material '): "where a composite active material is a single particulate entity made up of a
particle of active material to which one or more particles of additive material are fixed
such that the active and additive particles do not separate in the airstream"
The parties agree that a "composite active particle" is "made up of a particle of active
material to which one or more particles of additive material are fused." (D.I. 82 at 5). However,
Defendants seek to read several additional limitations into the disputed limitations and seek to
define the term "fused." (Id.).

2

For the '567 patent, Plaintiff proposes using "securely attached" in lieu of '. 'fused."
(D.I. 82 at 6).
4

First, Defendants argue that the intrinsic record establishes that Plaintiff clearly injected a
"milling" requirement into the "composite active particles" limitation. (D.I. 82 at 11 ).
Ordinarily, courts should not read process steps such as "milling" into composition claims.
However, "process steps can be treated as part of a product claim if the patentee has made clear
that process steps are an essential part of the claimed invention." Andersen Corp. v. Fiber

Composites, LLC, 474 F.3d 1361 , 1375 (Fed. Cir. 2007).
Here, Defendants argue that Plaintiff made "milling" an essential part of the claimed
invention by disclaiming non-milling processes for making "composite active particles" in both
the patent specification and prosecution history. (D.1. 82 at 11-13).
Plaintiff stated in the '991 patent Abstract, "The invention relates to a method for making
composite active particles ... , the method comprising a milling step . . .. The invention also
relates to compositions for inhalation prepared by the method." (See, e.g., '991 patent at 1:9-12,
2:3 -1 2, 2:35 -44). But the disputed claims do not include a milling requirement. Rather, the
milling method is separately claimed in the '661 patent, which shares a specification with the
'991 patent. (' 661 patent, claim 1). Defendants analogize Plaintiff's statements in the Abstract
to statements made in Medicines Co. v. Mylan, Inc. , 853 F.3d 1296 (Fed. Cir. 2017). (D.I. 82 at
13). There, the Federal Circuit concluded that a product claim requires the use of a process
"because the specification's definition of [the claim term] by itself injects a ... process as a
limitation in the asserted claims." Medicines, 853 F.3d at 1304. Here, on the other hand, the
Abstract does not provide a "definition" of "composite active particles" that includes "milling."
Rather, the patent plainly establishes that the relevant "invention" is a composition: "composite
active particles for use in a pharmaceutical composition." ('991 patent at 11 :44-55). Given that
this specification enables both composition and method claims, the specification's references to

5

"the invention" are ambiguous. Just because the specification describes a single known way to
make the claimed composition does not mean that I must read that method into the claims. Thus,
I do not find disclaimer based on the specification.
During prosecution of the ' 991 patent, Plaintiff stated, "As described in the ...
specification, the additive particles are fused to the active particle in a manner only possible
using an aggressive milling procedure." (D.I. 61-1 , Exh. 10 at 4). This statement came in
response to an anticipation rejection and explained why the patentee added the word
"particulate" to describe additive material. (Id.) . The patentee explained, "[T]he ... reference
cannot possibly teach, or suggest, particles comprising particulate surface modifier material . . .
." (Id. at 5). Separately, the patentee stated, " [The claimed composite particles] can only be

produced using high energy milling processes ... ." (Id. at 8). This statement came in response
to an obviousness rejection over the same reference. (Id.). Again, the patentee emphasized,
"[T]he advantages of the claimed composite particles arise as a consequence of the specific
structure, in which additive material is present on the surface of the active particles." (Id.).
Although the patentee did state that " [t]hese particles can only be produced using high energy
milling processes," the patentee never defined the "particles" on the basis of their formation by
"milling," nor did the patentee exclude "particles" formed by other processes. Instead, the
patentee distinguished the claimed invention on the basis of structure, or "particulate" additive
material. Thus, I do not find a clear and unambiguous disclaimer. I will not read the milling
process into the disputed claim limitations.
Second, Defendants argue that "composite active particles" must be formed by a
"uniform" blend of "only additive particles and active particles," and no carrier particles. (D.I.
82 at 14-17, 34-35). This limitation appears in a "comprising" claim. "' Comprising' is a term of

6

art used in claim language which means that the named elements are essential, but other elements
may be added and still form a construct within the scope of the claim." Genentech, Inc. v.
Chiron Corp., 112 F.3d 495 , 501 (Fed. Cir. 1997). Thus, the claimed "composite active

particles" may contain carrier particles, absent a teaching or disclaimer to the contrary.
Defendants argue that the patentee disclaimed formation of "composite active particles"
using anything other than "additive" and "active" particles. During prosecution of the '991
patent, the patentee stated, "[C]o-milling of active and additive material ... is the only method
that can produce the claimed composite particles." (D.I. 61-1 , Exh. 10 at 9) (underlining in
original). The patentee also stated that the milling process "involves firstly obtaining a uniform
blend of active and additive particles .... " (Id.). Plaintiff avers it was "only emphasizing that
the claimed invention involves blending 'particles' rather than the liquid-phase additive material
as disclosed in" the prior art. (D.I. 82 at 44). The patentee' s statements do not necessarily
exclude the presence of other particles in the milling process. Accordingly, they do not
constitute disclaimer. Furthermore, Plaintiff's arguments ultimately provide specific details
about the "milling" process. I am not reading a "milling" limitation into the claim. I will not
read these limitations into the claim for that additional reason.
Defendants also argue, " [I]n all of the examples directed to making composite active
particles . .. , only active ... and additive ... were milled together (with or without liquid)."3
(D.I. 82 at 14). However, neither the specification nor any embodiment includes any words or
expression of manifest restriction. See Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367,

3

The patent teaches that "milling" may occur with or without liquid. ('991 patent at
6:56-57) ("The milling may be wet milling, that is, the milling step may be carried out in the
presence of liquid."). However, because I am not reading a "milling" limitation into the claim, I
need not specify whether milling may occur with or without liquid.
7

1372 (Fed. Cir. 2014) (noting that disclaimer applies when, for example, the patentee makes
statements such as "all embodiments of the present invention are . .. " or "the present invention
requires . .. ," or the specification indicates that a feature of a preferred embodiment is a "very
important feature"). Thus, because the claim language does not restrict "composite active
particles" to formation by a "uniform" blend of "only additive particles and active particles," and
no carrier particles, I will not read those limitations into the claims.
Third, Defendants argue that milling must ensure dispersal and even distribution of the
additive over the active particles. (D.I. 82 at 18-19). " [P]rocess steps can be treated as part of a
product claim if the patentee has made clear that process steps are an essential part of the
claimed invention." Andersen Corp. , 474 F.3d at 1375. However, I am not reading a "milling"
process limitation into the claim. Accordingly, I will not read details about a "milling" process
limitation into the claim. Even if I were to interpret "even distribution of the additive over the
active particles" to be a structural limitation, rather than a process limitation, Defendants'
argument falls short. (D.I. 82 at 18-19). Defendants ' argument depends on a statement in the
' 991 patent specification that "a degree of intensive mixing is required to ensure ... even
distribution of additive over the host active particles" and on a reference to "coat[ing] the active
particle" in the ' 991 patent' s prosecution history. (' 991 patent, 3:9-14; D.I. 61-1 , Exh. 10 at 45). Defendants argue, Plaintiff "repeatedly referenced these limitations through the
specification" to define "[t]he method," meaning Plaintiff defined the claimed particles as
including "dispersal and even distribution of the additive over the active particles." (D.I. 82 at
18-19). However, this is not lexicography for the claimed particles. The patent never expressly
defines the claimed particles as including "dispersal and even distribution of the additive over the
active particles." Likewise, Defendants have not identified a "clear and unambiguous

8

disclaimer" that supports its construction. Accordingly, I will not read that limitation into the
claims.
Fourth, although the parties agree that "fused" is the proper term to describe the
interaction between the active and additive particles, they disagree on the correct definition of
"fusion." (D.I. 82 at 21). Defendants argue that the fusion between the active and additive
particles must be "irreversible." (Id. at 21-22). Plaintiffs aver that "fused" merely means
"securely attached . .. so that they remain associated during aerosolization and movement
through the air." (Id. at 6).
The intrinsic record on this point is not especially enlightening.
The concept of "fusion" appears in the patents' specifications, which distinguish fusion
from weaker contact adhesion. (See '991 patent at 3:31-34 ("In some cases a simple contact
adhesion may be insufficient and a stronger embedding or fusion of additive particles onto active
particles is required to prevent segregation, or to enhance the structure and functionality of the
coating.")).
During prosecution of the ' 991 patent, Applicant addressed fusion, arguing,
[T]he additive particles are fused to the active particle in a manner only possible
using an aggressive milling procedure. The additive particles thereby coat the
active particle, forming a single entity, a composite particle, which does not
dissociate upon, for example, incorporation into a formulation for inhalation or
upon actuation of the inhaler in which it is contained.
('991 patent File History: Response to Office Action (April 26, 2010) at 4-5 (D.I. 61-1 , Exh. 10
at 4-5) (citations omitted)).
These two intrinsic references to "fusion" clarify only that the relevant fusion is stronger
than "simple contact adhesion" and strong enough to prevent dissociation of the particles in
formula or upon actuation.

9

Defendants point primarily to extrinsic evidence to support their "irreversibly bound"
interpretation of "fusion. " (D.I. 82 at 20-21). Specifically, Defendants cite the prosecution
history of an unrelated Vectura patent, Patent No. 9,351 ,928 ("the ' 928 patent"). During
prosecution of the ' 928 patent, Applicant argued,
As one of ordinary skill in the art [] is aware, . . . a composite particle is a particle
which is a composite of two different materials, wherein the two materials are
inseparable. The claimed composite particles can only be produced by a high
energy process in which additive particles are pressed and smeared together with
the excipient particles. The result is a fine structure of composite particles
comprising small daubs of additive material randomly and irreversibly bound to
the surface of the excipient particles.
('928 patent file history: Response to Office Action (April 13, 2015) at 6 (D.I. 83-1 , Exh. 23 at
6). Defendants advocate that this statement is unambiguous evidence ofVectura's position on a
POSA' s understanding of a composite particle. (D.I. 82 at 21). Defendants also argue that
Plaintiff clearly defined "fusion" as "permanently attached" in a European patent, European Pat.
No. 1337239. (D.I. 82 at 20-21 (citing D.I. 83-1 , Exh. 26 at 8)). I do not find these unrelated
patents, addressing a somewhat different type of particle, compelling.
To clarify the "fusion" dispute, I heard expert testimony on the concept of "fusion" on
September 10, 2018. The parties' experts agreed that fusion in the pharmaceutical context would
not involve strong chemical bonds. (See Exp. Tr. at 13-14, 71-72). Rather, surface interactions
cause the fusion between the two particles and they remain chemically separate. (Id. at 72, 7576). However, the experts disagreed on the necessary strength of the surface interactions
between the active and additive particles.
Plaintiffs expert, Dr. John Koleng, testified that "fused" means "put on the surface with
sufficient energy in order to ensure that the particles do not disassociate or come apart during
that inhalation or actuation process from the inhalant." (Id. at 8). This construction is not based

10

on a POSA's understanding, because Dr. Koleng's position is that there was no accepted
meaning of "fused" at the relevant time. (Id. at 18-19). In contrast, Defendants' expert, Dr.
Paolo Colombo, testified that a POSA at the relevant time would understand, "Fusion is an
inseparable combination of an additive over an active particle. The result[] ofthis combination
is [the] creation of [a] single particulate entity, and this present[s] new physical chemical
properties." (Id. at 34). In support of his construction, Dr. Colombo cited contemporary sources
that indicate "fusion" meant particles are "fixed" or "imbedded." (See id. at 36-50). The
numerous sources presented by Dr. Colombo strongly indicate that a POSA would have had an
understanding of "fusion" at the relevant time.
I agree with Defendants that the "fusion" contemplated by the patents is something more
than a "secure attachment," but I doubt that the construction presented by Defendants' expert
would assist a jury in understanding the claims. Specifically, I am hesitant to include
"inseparable" or "irreversible." Dr. Colombo admitted during his testimony that covalent or ionic
bonds between the additive and active particles are not desirable in this field. (Id. at 71-72).
Moreover, Defendants acknowledged that the particles do separate in the lungs. (Id. at 84). This
is consistent with the '991 patent's specification and file history, which indicate that the relevant
time period for fusion is until the particles exit the airstream. 4 "Irreversible" and "inseparable"
do not capture the timing-specific nature of the fusion. Therefore, the construction will reflect
that "fusion" means "fixed such that the active and additive particles do not separate in the
airstream."

4

Plaintiff agreed at the hearing that the active and additive particles do not separate in the
airstream and admitted that the particles are inseparably fused at that time. (Exp. Tr. at 85-86).
11

Fifth, Defendants argue that the "microparticles" limitation of the '567 patent has the
same meaning as the "composite active particles" limitation of the ' 991 patent in the context of
the claims. (D.I. 82 at 19-21 ). Defendants aver, "[Plaintiff] points to nothing in the specification
where microparticles are defined in terms of ' attachment,' nor does it explain why a POSA
would have necessarily interpreted the hydrophobic and active particles within microparticles as
being attached in view of this [spray drying] embodiment." (Id. at 20). Plaintiff, however,
argues that the construction of the "microparticles" limitation of the ' 567 patent should use
"securely attached" instead of "fused." (Id. at 10-11 , 33). Plaintiff asserts that using "fusion" for
the ' 567 patent would read out that patent' s "non-mechanical" milling method, "spray drying."
(Id. at 10).

I agree with Defendants. The ' 567 patent' s specification does not discuss microparticles
in terms of attachment. Additionally, Plaintiff sought to define "fused" as "securely attached" in
the ' 991 patent's construction and then to use the term "securely attached" in the ' 567 patent's
claim construction. (Se e id. at 6, 33). This is circular. If "fused" means "securely attached," and
microparticles are "securely attached," then it follows that microparticles are properly described
as "fused." I will construe the ' 991 and ' 567 patents consistently.
Sixth, Defendants argue that "additive material" must form "a continuous coating or a
discontinuous coating covering, on average, at least 50% of the total surface area of the active
particles." (D.I. 82 at 23 -26).
The patents teach only that there must be "an amount of an added material." (' 991
patent, 2:12-19). The patents characterize a coating as a preferred embodiment for this "amount"
of additive, stating, "The additive material is preferably in the form of a coating on the surfaces
of the particles of active material." (' 991 patent, 2:12-19, 6:38-42).

12

However, Defendants argue that " (r]egardless (of] whether the patents-in-suit
characterize the coating as a preferred embodiment," Plaintiffs disclaimer requires a coating
limitation. (D.I. 82 at 24). During prosecution of the ' 991 patent, Plaintiff stated, " [T]he
additive particles are fused to the active particle ... , thereby coat[ing] the active particle,
forming a single particulate entity, a composite particle." 5 (D.I. 61-1 , Exh. 10 at 4-5). However,
this statement is not inconsistent with the proposition that fusion can sometimes result in the
preferred embodiment of a coating of additive.
I cannot read a preferred embodiment into the claims. Phillips, 415 F.3d at 1323 ("(W]e
have expressly rejected the contention that if a patent describes only a single embodiment, the
claims of the patent must be construed as being limited to that embodiment."). Accordingly, I
will not read the coating limitation into the claims. 6

5

Defendants point to two other disclaimers. First, Defendants note that during
prosecution of the '567 parent patent, the applicant stated, " (S]uch a controlled coating process
results, inter alia, in a consistent coating of hydrophobic particles on individual active particles."
(D.I. 82 at 23 (citing D.I. 61-1 , Exh. 15 at 6)). Second, Defendants note that during prosecution
of a "related foreign patent," the applicant stated, "[F]orming composite particles by fusing one
material to another will result in a different distribution of the materials, with one material
forming a coating on the surface of the other." (D.I. 82 at 23 -24 (citing D.I. 83-1 , Exh. 24 at 4)).
However, Defendants do not argue that the milling process described in those patents is identical
to the milling process described in these patents. Furthermore, these statements are not
inconsistent with a coating being a preferred embodiment, as fusion and milling can result in a
coating. Thus, I do not find disclaimer.
6
Defendants further request that the coating limitation be specified as covering "at least
50% of the total surface area of the active particles." Defendants obtain this number from the
specification, which stated, "Where the coating is discontinuous, it preferably covers, on
average, at least 50% (that is, at least 50% of the total surface area of the active particles will be
covered by additive material)." ('99 1 patent, 6:38-49). However, this is merely a preferred
embodiment. Even if I found that a coating limitation should be present, I could not read this
50% requirement into the claims. Phillips, 415 F.3d at 1323. As discussed at oral argument,
ladybugs can "coat" a soccer ball, even when covering less than 50% of the soccer ball's surface
area. (Tr. 39:13-23).
13

Taken together, I construe "composite active particle[s]" to mean " [a] single particulate
entit[y/ies] made up of a particle of active material to which one or more particles of additive
material are fixed such that the active and additive particles do not separate in the airstream" and
"each composite active particle comprising a particle of active material and particulate additive
material on the surface of that particle of active material" to mean "where a composite active
material is a single particulate entity made up of a particle of active material to which one or
more particles of additive material are fixed such that the active and additive particles do not
separate in the airstream."
B. "milled" and "a milling step in which particles of active material are milled in the
presence of particles of an additive material" ('661)

l. Plaintiff's proposed construction ( "a milling step in which particle of active material are
milled in the presence ofparticles of an additive material''): "a step in which particles of
active material are processed in the presence of particles of additive material using any
mechanical process that applies sufficient force such that one of more particles of
additive material become fused to a particle of active material"
2. Plaintiff's proposed construction ( "milled''): "processed using any mechanical process
that applies sufficient force such that one of more particles of additive material become
fused to a particle of active material"
3. Defendants ' proposed construction ( "a milling step in which particle of active material
are milled in the presence ofparticles of an additive material ''):

"milling a uniform blend of only additive particles and active particles (with or without
liquid) using sufficient energy and duration to ensure sufficient break-up of agglomerates
of both constituents, dispersal, and even distribution of additive over the active particles"
The milling step does not comprise blending
4. Defendants ' updated construction ( "milling ''): "subjected to a mechanical process which
applies sufficient force to the particles of active material that it is capable of breaking
coarse particles (for example, particles of mass medium aerodynamic diameter greater
than 100 µg) down to fine particles of mass medium aerodynamic diameter not more than
50 µg or which applies a relatively controlled compressive force such as in the MechanoFusion or Cyclomix methods, wherein said process uses sufficient energy and duration to
ensure sufficient break-up of agglomerates of both additive particles and active particles,
dispersal, and even distribution of additive over the active particles"

14

Plaintiff noted that these disputed terms, which appear in the'661 patent, "may remain in
the case depending on the Court's construction of the claim terms in" the '991 and '5 67 patents.
(D.I. 117 at 2). In Section III.A, I decline to read the milling process into the claims.
Accordingly, I need not construe these terms.
C. "wherein the additive material promotes the dispersion of the composite active
particles upon actuation of a delivery device" ('991), "suitable for promoting the
dispersal of the active particles on actuation of an inhaler" ('567)
1. Plaintiff's proposed construction ( "wherein the additive material promotes the

dispersion of the composite active particles upon actuation of a delivery device '') :
"wherein a composition that contains one or more composite active particles has
increased dispersion of the active material upon activating a delivery device for
inhalation into the lungs by a patient, as compared to the active material without the
additive material"
2. Plaintiff's proposed construction ( "suitable for promoting the dispersal of the active
particles on actuation of an inhaler ''): "suitable for increasing dispersal of an active
material upon activating an inhaler, as compared to the active material without the
additive material"
3. Defendants ' proposed construction (both terms): This term is indefinite.
4. Court's construction ("wherein the additive material promotes the dispersion of the
composite active particles upon actuation of a delivery device ''): "wherein a composition
that contains one or more composite active particles has increased dispersion of the active
material upon activating a delivery device for inhalation into the lungs by a patient, as
compared to the same composition wherein unmodified active particles are substituted
for the composite active particles"

5. Court 's construction ("suitable for promoting the dispersal of the active particles on
actuation of an inhaler''): "suitable for increasing dispersal of an active material upon
activating an inhaler, as compared to the same composition wherein unmodified active
particles are substituted for the microparticles"
The parties agree that efficiency of dispersal can be measured using a twin stage impinger
(TSI), a device that simulates the respiratory tract and is used in the assessment of inhalers. (D.I.
82 at 57). Plaintiff argues that the claims require measuring the efficiency of dispersal of the

claimed composition absent additive material, measuring the efficiency of the claimed

15

composition with additive material, and looking for "increasing dispersal." (Id.). Plaintiff
further argues, "[A] POSA would have understood from the patents-in-suit that if a composition
comprising additive material fused to active material has improved dispersal compared to the
same composition without additive material, then the increased dispersal of the active particles is
in part attributed to the additive material that is fused to the active particles." (D.I. 82 at 66).
Defendants, however, argue that these claim terms are indefinite. (D.I. 82 at 56). "[A]
patent is invalid for indefiniteness if its claims, read in light of the specification delineating the
patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the
art about the scope of the invention." Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120,
2124 (2014). Specifically, Defendants argue that there is no objective way for a skilled artisan to
know whether an additive "promotes" dispersion. (D.I. 83 at 59-61). They continue, "The
Dispersion Limitations are concerned solely with improved dispersibility resulting from a single
particle-particle interaction-fusion-between additive and active particles." (Id. at 59). Thus,
for a composition having both the claimed composite active particles and other particles, like
carrier particles, Defendants say "single fusion interaction . . . must be isolated from those of all
other particle interactions." (Id. at 60). Defendants argue, " [A] POSA would have known that
there was no scientifically established means for isolating any one of myriad particle-to-particle
interactions," meaning the claims cannot possibly be fulfilled. (Id.).
Plaintiff responds that the claims do not have an "isolation" of fusion requirement. (D.I.
82 at 65). Rather, Plaintiff says, Defendants' reading is "untenable," because a skilled artisan
would not read the claims as requiring isolating the fusion interaction, and would know that such
an analysis is scientifically impossible. (Id. at 67).

16

I agree with Plaintiff that the claims are not indefinite. The claim language requires
measuring the efficiency of dispersal of a composition with unmodified active particles,
measuring the efficiency of the composition with composite active particles, and looking for
increased dispersal. The claims do not require isolating the fusion interaction as the sole source
of the increased dispersion. This is indicated in Example 4, which compares the dispersal of
composite active particles to the dispersal of unmodified active particles. ('991 patent, 14:3115 :48). 7 Example 4 reports the results of a test of a fairly simple composition, so it must be
viewed as merely illustrative of how a POSA would approach testing the efficacy of the patented
particles. However, it highlights that a POSA would understand that, to test whether the
additive 8 is promoting or suitable to promote dispersion in a given composition, she would need
to control for all variables that may contribute to dispersion. Therefore, isolating the impact of
the composite active particles on the overall dispersion of the composition is the relevant
inquiry. 9 I find that Example 4, in the context of the patent, sufficiently informs a POSA of how
to approach this testing. Accordingly, I reject Defendants' assertion that the claims are
indefinite.
Because Defendants did not propose an alternative construction, I will adopt a
construction mirroring the construction proposed by Plaintiff. However, I disagree with
Plaintiffs characterization of Example 4. Example 4 does not teach that the relevant inquiry is

7

Notably, the composition tested in Example 4 does not contain carrier particles or other
particles extraneous to the composite active particles. (' 991 patent, 14:31-15:48). However, the
specification teaches that the compositions "may comprise additional ingredients such as carrier
particles." (Id. at 12:8-11).
8
Additive in this context refers to the material fused to the active to form a composite
active particle or microparticle
9
If a POSA wanted to determine whether composite active particle C2 increased
dispersion compared to active particle C, in a composition also containing particles A and B, she
would not vary A and B during testing.
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the presence or absence of additive material. This cannot be the case because the patent teaches
that additive materials, as a general matter, were known in the prior art to promote dispersion.
('991 patent, 1:55-58). Rather, Example 4 teaches that testing compositions with composite
active particles and comparing those results to compositions with unmodified active particles is
the proper approach for determining whether the additive material of the claimed invention is
promoting dispersion. Accordingly, I construe "wherein the additive material promotes the
dispersion of the composite active particles upon actuation of a delivery device" to mean
"wherein a composition that contains one or more composite active particles has increased
dispersion of the active material upon activating a delivery device for inhalation into the lungs by
a patient, as compared to the same composition wherein unmodified active particles are
· substituted for the composite active particles" and "suitable for promoting the dispersal of the
active particles on actuation of an inhaler" as "suitable for increasing dispersal of an active
material upon activating an inhaler, as compared to the same composition wherein unmodified
active particles are substituted for the microparticles."
D. "suitable for delaying the dissolution of the active substance" ('567)

1. Plaintiff's proposed construction: "suitable for delaying the dissolution of an active
substance, as compared to the active substance without the hydrophobic material"
2. Defendants' proposed construction: This term is indefinite.
3. Court 's construction: "suitable for delaying the dissolution of an active substance, as
compared to the active substance without the hydrophobic material"
The parties agree that a composition' s "dissolution" is testable. (D.I. 82 at 77, 80).
Plaintiff argues, " [D]issolution testing is performed on the composition containing

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microparticles, which is compared to the composition without the hydrophobic material." 10, 11

(Id. at 79).
Defendants argue that this term is indefinite. (Id. at 76). Defendants argue that the
claims require that delayed dissolution "result[ s] from a single particle-to-particle interactionfusion-between hydrophobic and active particles." (Id.). Defendants argue that the intrinsic
record teaches that "the samples to be tested are the microparticles themselves," rather than "the
full composition at issue," which might include carrier particles. (Id. at 76-77). Defendants
point to several parts of the specification, which provide that "microparticles [are] tested." (Id. at
77 (citing ' 567 patent, 17:7-12)).
However, the intrinsic record makes clear that dissolution testing can be performed on
entire formulations. (See, e.g. , ' 567 patent at 16:16-30 (" Standard Dissolution Test ... 1mg of
the formulation to be tested is placed on the sinter and a timer is started."); Id. at 17:30-35 ("if
the concentration of the active substance in the dissolution test on the formulation reached ... ")).
In fact, the quote relied on by Defendants is merely inclusive of testing on microparticles alone .
It states that measuring the "delayed release performance of a particular formulation ... can be
done by carrying out the standard dissolution test given above on a sample of the microparticles
to be tested." (Id. at 17:7-12). Furthermore, Defendants do not point to any part of the
specification which requires only testing microparticles in isolation. Rather, the specification

10

The '567 patent claims provide that the "hydrophobic" and "active particles" form a
"microparticle." (' 567 patent, claim 1).
11
Defendants argue that this statement represents Plaintiffs effort to "vastly expand the
scope of these limitations," as compared to Plaintiffs original construction. (Tr. 112:3-113:9). I
disagree. In making this statement, Plaintiff merely clarifies the scope of its proposed
construction.
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provides that "compositions . . . may comprise additional ingredients such as carriers . . . .
Preferably, the carrier particles are of lactose." (Id. at 6:62-7:25).
Accordingly, I find the claim terms not indefinite. I adopt Plaintiffs proposed
construction. Defendants do not substantively dispute Plaintiffs proposed construction, aside
from its indefiniteness argument. (D.I. 82 at 76-79).
E. Other terms

In their briefing, the parties argue constructions for various other terms. They do not
seriously dispute the meaning of these terms, but rather argue that they will enhance the jury' s
understanding. (D.I. 82 at 73-75). As discussed at oral argument, these clarifications are
unnecessary. (Tr. 110: 12-111: 19). Accordingly, I will not construe the terms.

IV.

CONCLUSION
Within five days the parties shall submit a proposed order consistent with this

Memorandum Opinion.

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