PURDUE PHARMACEUTICAL PRODUCTS L.P. et al v. ACTAVIS ELIZABETH LLC

Filing 185

OPINION fld. Signed by Judge Jose L. Linares on 6/11/14. (sr, )

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

PURDUE PHARMACEUTICAL
PRODUCTS, LP., et al.
Plaintiffs,
v.

Civil Action No. 12-5311 (JLL)
[Consolidated with Civil Action No. 13-5003]

ACTAVIS ELIZABETH, LLC, et al.
Defendants

OPINION

PURDUE PHARMACEUTICAL
PRODUCTS, L.P., et al.

Plaintiff,
V.

TWI PHARMACEUTICALS, INC.
Defendants.

LINARES, District Judge.
This patent infringement action stems from various gene
ric drug manufacturers’ attempts
to obtain Food and Drug Administration (“FDA”) approval
to market a generic version of
Plaintiffs Purdue Pharmaceutical Products, L.P. (“Purdue
Pharmaceutical”), Purdue Pharma, L.P.
(“Purdue Pharma”), and Transcept Pharmaceuticals, Inc.
(“Transcept”) (collectively
“Plaintiffs”)’s Intermezzo®, a drug used to treat midd
le-of-the-night (“MOTN”) insomnia.

1

Before the Court is an application for claim construction by Plaintiffs
and Defendants
Actavis Elizabeth, LLC; Novel Laboratories, Inc.; Par Pharmaceutical,
Inc.; Dr. Reddy’s
Laboratories, Inc.; Dr. Reddy’s Laboratories, Ltd; and TWi Pharmaceutic
als, Inc. (collectively,
“Defendants”). Specifically, the parties seek the Court’s interpretation
of certain language
contained in the claims of United States Patent Nos. 7,682,628 (the “628
Patent”), 8,242,131
(the “131 Patent”), and 8,252,809 (the “809 Patent”).
The Court held a Markman hearing on May 8, 2014, and has considered
the parties’
written and oral arguments. The Court sets forth herein its construction
of the disputed claim
terms.
I.

BACKGROUND

Purdue Pharmaceutical is the current holder of New Drug Application
No. 022328, for
sublingual tablets containing 1.75 mg and 3.5 mg of zolpidem tartrate
, which the FDA approved
on November 23, 2011 to treat MOTN insomnia. (CM/ECF No.
36 at ¶ 28.) Purdue Pharma
markets the approved drug under the tradename Intermezzo®. (Id.)
While other approved sleep drugs, such as Ambien®, help patients
with difficulty falling
asleep, intermezzo® induces sleep in the middle of the night in patient
s suffering from MOTN
1
insomnia. (See, e.g., CMIECF No. 95 at 7.) The active ingred
ient in Intermezzo® is
zolpidem—the same active ingredient in Ambien®. (See, e.g.,
id.) Nevertheless, Intermezzo®
uses half the dose of zolpidem than that used in Ambien®. (Id.)
Additionally, the delivery
method of zolpidem in Intermezzo® is different. Whereas Ambie
n® is swallowed as a tablet,
Intermezzo® delivers zolpidem transmucosally (i.e., sublingually).
(CM/ECF Nos. 93 at 8; 95 at

The parties agree that MOTN inson-mia is a “condition wherei
n a subject, after falling asleep, awakens and has
difficulty returning to sleep.” (CM/ECF No. 92 at 2.)

2

7.) This allows for the drug to work more rapidly than Ambien® without causing the patient
to
experience grogginess in the morning. (CM/ECF Nos. 93 at 8-9; 95 at 7.)
There are four patents covering Intermezzo®: (1) the ‘628 Patent, entitled “Composition
s
for delivering hypnotic agents across the oral mucosa and methods of use thereof;” (2) the ‘131
Patent, entitled “Methods of treating middle-of-the-night insomnia;” (3) the ‘809 Patent, entitle
d
“Compositions for treating insomnia;” and (4) United States Patent No. 7,658,945 (the “945
Patent”) which, like the ‘628 Patent, is entitled “Compositions for delivering hypnotic agents
across the oral mucosa and methods of use thereof.” (CM/ECF No. 152 at 5.)
Plaintiffs allege that in filing Abbreviated New Drug Applications to market generic
versions of Intermezzo®, Defendants have infringed the ‘628, ‘131, and ‘809 Patents. (See
generally CM/ECF No. 36.)
II.

LEGAL STANDARD

“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. A WHCorp., 415 F.3d
1303, 1312
(Fed. Cir. 2005). “When the parties present a fundamental dispute regarding the scope
of a claim
term, it is the court’s duty to resolve it.” 02 Micro Int’l Ltd. v. Beyond Innovation
Tech. Co.,
521 F.3d 1351, 1362 (Fed. Cir. 2008).
“{Tjhe words of a claim are generally given their ordinary and customary meanin
g”
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.” Phillips, 415 F.3d at 1312-13 (internal quotations
omitted). A
court “must look at the ordinary meaning in the context of the written descrip
tion and the
prosecution history.” Medrad, Inc. v. MRJ Devices Corp., 401 F.3d 1313, 1319
(Fed. Cir. 2005).
Courts should turn to “those sources available to the public that show what
a person of skill in
3

the art would have understood disputed claim language to mean.” Innova/Pure Water,
Inc. v.
Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004).

To this end, the court should first examine the intrinsic record—the patent itself,
including the claims, the specification and, if in evidence, the prosecution history
. Vitronics
Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The specification
“acts as a
dictionary when it expressly defines terms used in the claims or when it defines
terms by
implication.” Id. Indeed, the Federal Circuit has explained that the specification
is “usually.
dispositive.

.

.

[and] the single best guide to the meaning of a disputed term.” Phillips, 415 F.3d

at 13 15 (quoting Vitronics, 90 F.3d at 1582). It is “entirely appropriate for court,
a
when
conducting claim construction, to rely heavily on the written description for guidan
ce as to the
meaning of the claims.” Id. at 1317. The specification is also an important guide
in claims
construction as it may contain “an intentional disclaimer, or disavowal, of claim
scope by the
inventor.” Id. at 1316.
Additionally, the court should consult the patent’s prosecution history as it “provi
des
evidence of how the PTO and the inventor understood the patent.” Id. at 1317.
Moreover, the
prosecution history “can ofien inform the meaning of the claim language by
demonstrating how
the inventor understood the invention and whether the inventor limited the
invention in the
course of prosecution, making the claim scope narrower than it would otherw
ise be.” Id. Courts
should, nevertheless, be circumspect in reviewing a prosecution history
as it represents “an
ongoing negotiation between the PTO and the applicant, rather than the
final product of that
negotiation.” Id.
A district court may also examine extrinsic evidence

—

“all evidence external to the patent

and prosecution history.” Markman v. Wesiview Instruments, Inc., 52 F.3d
967, 980 (Fed. Cir.
4

1995). Such evidence consists of expert statements, dictionaries, and treatises. Id.
In particular,
a court may find reference to technical dictionaries useful “in determining the meanin
g of
particular terminology.” See Phillips, 415 F.3d at 1318. However, extrinsic eviden
ce is
generally thought to be less reliable than the patent and prosecution history, id. at 1318-1
9; in
essence, extrinsic evidence is “less significant than the intrinsic record in determining
the legally
operative meaning of claim language,” C.R. Bard, Inc. v. US. Surgical Corp.,
388 F.3d 858, 862
(Fed. Cir. 2004) (quotation omitted).
IlL

LEGAL DISCUSSION

The parties seek construction of the following terms: (1) “without residua sedativ
l
e
effects,” contained in Claims 1 and 12 of the ‘131 Patent; (2) “A solid unit dosage compo
sition for
the treatment of MOTN insomnia, said composition comprising,” which is the
preamble to Claims
I and 12 of the ‘809 Patent; (3) “effective amount of zolpidem,” contained in
Claims I and 12 of
the ‘809 Patent; (4) “buffer,” contained in Claim 1 of the ‘628 Patent; (5)
“buffering agent,”
contained in Claim 12 of the ‘809 Patent; and (6) “binary buffer system,” contain
ed in Claims 5,

6, 22, and 23 of the ‘809 Patent. The Court will now proceed to address the proper
2
construction
of these disputed terms.
A.

“Without residual sedative effects”

“Without residual sedative effects” appears in Claims 1 and 12 of the ‘131 Patent.
These
claims state the following:
Claim 1: A method of treating middle-of-the night
insomnia in a non-elderly patient without prophylactically
2

At oral argument, the Court instructed the parties to confer and attempt to agree
upon a construction for “binary
buffer system” and “buffering agent.” On May 22, 2014, Plaintiffs filed
a letter on behalf of all parties making the
Court aware that the parties were unable to agree on how these terms should
be construed. The parties did, however,
exchange “compromise proposed constructions,” which have made severa of
l the arguments raised in the briefs and
at oral argument moot. (See CM/ECF No. 178.) For purposes of constru
ing “binary buffer system” and “buffering
agent,” the Court has considered the propriety of adopting each party’s respec
tive “compromise proposed
construction.”

5

administering zolpidem, comprising: dosing the patient
with a pharmaceutical composition comprising about 0.5 to
about 4.75 mg of zolpidem hemitartrate or a molar
equivalent amount of a pharmaceutically acceptable form
of zolpidem, wherein the pharmaceutical composition is
substantially free of other hypnotic agents, wherein the
patient awakens from sleep and desires to resume sleep for
less than 5 hours, wherein the step of dosing the
pharmaceutical composition is performed after the patient
awakens from sleep, and wherein the pharmaceutical
composition permits the patient to awaken at a time about
four hours after dosing without residual sedative effects.
Claim 12: A method of treating middle-of-the-night
insomnia in an elderly patient without prophylactically
administering zolpidem, comprising dosing the patient with
a pharmaceutical composition comprising about 1.5 to 2.5
mg of zolpidem hemitartrate or a molar equivalent amount
of a pharmaceutically acceptable form of zolpidem,
wherein the pharmaceutical composition is substantially
free of other hypnotic agents, wherein the patient awakens
from sleep, and desires to resume sleep for less than 5
hours, wherein the step of dosing the pharmaceutical
composition is performed after the patient awakens from
sleep, and wherein the pharmaceutical composition permits
the patient to awaken at a time about four hours after
dosing without residual sedative effects.
Plaintiffs maintain that this Court should construe “without residual sedative effects” to
mean “with no or minimal subjective feelings of sedation, as evaluated by: (a) testing acceptably
in at least one test exploring psychomotor performance, attention, information processing, and
memory used by those of skill in the art; and/or (b) demonstrating plasma levels of zolpidem,
at
an appropriate time point, below about 29 ng/ml.” Defendants, on the other hand, have not
proposed a construction for “without residual sedative effects.” In fact, they concede that “the
definition for the claim term ‘without residual sedative effects’ appears in the ‘131 Patent
specification.” (CM/ECF No. 103 at 13.) Nevertheless, Defendants argue that the term is
indefinite.

6

At the outset, the Court notes that the first portion of Plaintiffs’ proposed construction
(i.e., “with no or minimal subjective feelings of sedation”) largely mirrors the specifi
cation’s
definition of “residual sedative effects,” which is “a patient’s subjective feeling of sedatio
n upon
awakening.” (‘131 Patent at 6:41-42.) The specification makes clear that “the term [‘resid
ual
sedative effects’] is meant to refer to a patient population as found in, for example, a clinica
l
trial, rather than a single patient example.” (‘131 Patent at 6:43-45.)
The remainder of Plaintiffs’ proposed construction is also consistent with the
specification’s description of how a person of ordinary skill in the art would evalua
te a
subjective feeling of sedation. Specifically, the specification provides that “[r]esidual sedativ
e
effects.

.

.

can be evaluated using one or more of a number of tests exploring psychomotor

performance, attention, information processing, and memory used by those of skill in
the art...
[and that] an amount [of zolpidem] that substantially avoids or does not produce residua
l
sedative effects is an amount that allows a subject, upon awakening, to test accept
ably in at least
one of.

.

.

[these] tests.

.

.“

(‘131 Patent at 6:45-67-—-7:1-2.) Consistent with Plaintiffs’

proposed construction, the specification also provides an alternative means of measu
ring residual
sedative effects by reference to a subject’s plasma levels of zolpidem. The specifi
cation states
that “residual sedative effects will be essentially extinguished when a subject’s
plasma levels of
zolpidem fall below about 20 ng/ml.

.

.

in a patient population.” (‘131 Patent at 7:5-12.)

With respect to Defendants’ indefiniteness argument, the U.S. Supreme Court has
held
that courts should hold a claim to be indefinite and, therefore, invalid, “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, No. 13-369, 2014 U.S. LEXIS 3818, at *6 (June 2, 2014).
Defendants
7

maintain that “without residual sedative effects” is indefinite because, while the specifi
cation
sets forth a number of methods for determining whether someone taking zolpidem awake
ns
without residual sedative effects, it fails to define which of these methods governs.
Additionally,
Defendants contend that Plaintiffs’ proposed construction “conflate[s] the subjective
and
objective methods” for measuring residual sedative effects. (CM/ECF No. 103 at 17.)
To
illustrate its point, Defendants argue that “it is conceivable that a person, after ingesti
ng
zolpidem and sleeping for four hours, wakes up feeling fine, i.e., ‘no or minimal subjec
tive
feeling of sedation,’ but obtains plasma levels of zolpidem above 20 ng/ml.” (CM/E
CF No. 93
at 25.) Defendants point out that in such an instance, it would be unclear whether a person
’s
ingestion of zolpidem would infringe the ‘131 Patent because the person would meet the
subjective assessment but not the objective one. (Id.)
Defendants largely rely on Honeywell mt ‘1, Inc. v. JTC, 341 F.3d 1332 (Fed. Cir.
2003)
for the proposition that “without residual sedative effects” is indefinite. (See, e.g.,
Tr. at 20.)
Honeywell involved a patent disclosing “a process for production of a particular multifi
lament
polyester product called polyethylene terephthalate (“PET”) yarn” used as a reinfor
cement for
automobile tires. Honeywell, 341 F.3d at 1334. All claims in the patent at issue
“require[d] that
the yarn produced by the claimed process fall within a specified.

.

.

[melting point elevation] at

some point during the process.” Id. at 1335. The dispute in the case “focus
ed on the method of
measuring one claimed feature—the melting point elevation (“MPE”).” Id.
Although there were
four methods for preparing PET yarn that were well known to persons of
ordinary skill in the art,
“neither the claims, the written description [of the patent at issue], nor the
prosecution history
reference[d] any of the four sample preparation methods that can be used
to measure the MPE.”
Id. at 1339. The court noted that depending upon which method was used,
“the calculated MPE
8

for a given sample can vary greatly.” Id. at 1336. Ultimately, the court held that the claims
containing the disputed term “melting point elevation” were “insolubly ambiguous, and hence
indefinite” because “the claims, the written description, and the prosecution history fail[ed
] to
give.. any guidance as to what one of ordinary skill in the art would interpret the claim
to
.

require.” Id. at 1340. The court emphasized that because the “preparation method [was]
critical
to discerning whether a PET yarn ha[d] been produced by the claimed process, knowi
ng the
proper.

.

.

preparation method [was] necessary to practice the invention.” Id.

Defendants argue that just as the patent at issue in Honeywell failed to specify which
method governed the measurement of MPE, the ‘131 Patent fails to specify which test
governs
the measurement of residual sedative effects. Additionally, without citing to any expert’s
statement or other evidence in the record, Defendants assert that, like the methods for measu
ring
MPE in Honeywell, the methods for measuring residual sedative effects in the ‘131 Patent
produce inconsistent results. (CM/ECF No. 93 at 25.)
Defendants’ arguments do not persuade the Court that it would be appropriate, at this
juncture, to hold that Claims 1 and 12 of the ‘131 Patent are indefinite for two primar
y reasons.
First, whereas the patent at issue in Honeywell did not set forth the methods for measu
ring MPE,
the ‘131 Patent does set forth specific tests for measuring residual sedative effects
. (See, e.g.,
‘131 Patent at 6:45-67—7:1-2.) Second, the Federal Circuit has made clear that
a patent is not
indefinite merely because it fails to specify which method of measurement should
be used, or
because different methods may produce different results. See Takeda Pharm. Co.
v. Zydus
Pharms. USA, Inc., 743 F.3d 1359, 1366 (Fed. Cir. 2014) (rejecting argum
ent that patent was
indefinite because it did “not specify the method of measurement that should
be used to
determine average particle diameter,” while acknowledging that various method
s used to
9

approximate average particle diameter “can produce different results even for the same
sample.”); see also id. at 1367 n.3 (noting that “the potential for inconsistent results even within
the same method of measurement.

.

.

surely does not render a claim indefinite.”). The critical

inquiry is whether the method of measurement is “outcome-determinative in the infringement
analysis.” Id. at n.4 (distinguishing Honeywell on the basis that in that case the method of
measurement was “critical to discerning whether [an infringing yarn) has been produced by the
claimed process.”) (bracketed text in original).
At this time, it would be premature for this Court to hold that the method of measuring
residual sedative effects would be outcome-determinative. This is particularly so because
Defendants have not proffered any expert statement, or pointed to any evidence in the record to
show that the method of measuring residual sedative effects is critical to the infringement
analysis. See, e.g., C’acace

i

Meyer Mktg. (Macau Commercial Offshor,) C’o., Ltd., 812 F. Supp.

2d 547, 561 (S.D.N.Y. 2011) (observing that “mere attorney argument is insufficient to establish
invalidity based on indefiniteness.”).
As Plaintiffs’ proposed construction is consistent with: (1) the ‘131 Patent specification’s
definition for “without residual sedative effects” and (2) the method for measuring “without
residual sedative effects” set forth in the ‘131 Patent specification, this Court will adopt
Plaintiff’s proposed construction for “without residual sedative effects.” See, e.g., Martek
Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1380 (Fed. Cir. 2009) (“When a patentee
explicitly defines a claim term in the patent specification, the patentee’s definition controls.”).
Further, the Court declines to resolve Defendants’ indefiniteness argument at this time.
See, e.g.,
Waddington N. Am., Inc. v. Sabert Corp., No. 09-4883, 2010 WL 436317, at *2..3 (D.N.J.
Oct.
27, 2010) (declining to resolve indefiniteness argument at the claims construction
stage as the

10

issue was “more appropriately tackled at summary judgment.”); A icon Research Ltd. v. Barr
Labs, Inc., No. 09-03 18, 2011 WL 3901878, at *16 (D. Del. Sept. 6, 2011) (“We find that the
indefiniteness issue is best decided at trial and defer consideration on it until that time.”).
Defendants

may,

nevertheless, renew their indefiniteness argument at a later point in this

litigation.
B.

“effective amount of zolpidem” and Preamble “a solid unit
dosage composition for the treatment of MOTN insomnia, said
composition comprising”
—

The terms “effective amount of zolpidem” and “a solid unit dosage composition for the
treatment of MOTN insomnia, said composition comprising” appear in Claims 1 and 12 of the
‘809 Patent. These claims state the following:
Claim 1: A solid unit dosage composition for the treatment
of MOTN insomnia, said composition comprising an
effective amount of zolpidem or a salt thereof, formulated
for delivery across a subject’s oral mucosa, wherein said
effective amount is an amount of less than 1.30x10 moles
5
of zolpidem, and is an amount sufficient to produce a
plasma concentration between 25 ng/ml and about 50 ng/ml
within 20 minutes of administration, when evaluated in an
appropriate patient population.
Claim 12: A solid unit dosage composition for the
treatment of MOTN insomnia, said composition
comprising an effective amount of zolpidem or a salt
thereof and at least one buffering agent, formulated for
delivery of zolpidem across a subject’s oral mucosa,
wherein said effective amount is 0.5 to 4.75 mg of
zolpidem hemitartrate, and is an amount sufficient to
produce a plasma concentration between 25 ng/ml and
about 50 nglml within 20 minutes of administration, when
evaluated in an appropriate patient population.
a.

“effective amount of zolpidem”

Plaintiffs maintain that “effective amount of zolpidem” should be construed to mean
“amount of zolpidem that is capable of achieving a therapeutic effect in a subjec in
t need
11

thereof.” Defendants, on the other hand, assert that “effective amount of zolpidem” is defined
by
Claims 1 and 12, themselves. Specifically, they argue that for Claim 1, the Court should
construe “effective amount of zolpidem” as “an amount of less than 1 .30x10 moles
5
of
zolpidem, and is an amount sufficient to produce a plasma concentration between 25 ng/ml
and
about 50 ng/ml within 20 minutes of administration.” For Claim 12, Defendants argue that
“effective amount of zolpidem” should be construed as “0.5 to 4.75 rng of zolpid
em hemitartrate,
and is an amount sufficient to produce plasma concentration between 25 ng/ml and about
50
ng/ml within 20 minutes of administration.”
As an initial matter, there is no dispute that the specification defines “effective amount”
as “the amount of zolpidem that is capable of achieving a therapeutic effect in a subjec in need
t
thereof” (‘809 Patent 7:48-50.) Plaintiffs’ proposed construction is identical to the langua
ge of
the specification defining “effective amount.” Defendants, nevertheless, suggest that
the
specification’s definition should not control because the body of Claims 1 and 12, respec
tively,
“explicitly defines what an effective amount of zolpidem is.” (CM/ECF No. 93 at
28.) In
arguing that the Court should decline to look beyond the language of Claims 1 and
12 in
construing “effective amount of zolpidem,” Defendants largely rely on Renishaw
PLC v.
Marposs Societa Per Azioni, a case in which the Federal Circuit observed that
“the claim
‘

construction inquiry.

.

.

begins and ends in all cases with the actual words of the claim.” 158

F.3d 1243, 1248 (Fed. Cir. 1998). In that very same case, however, the Federal Circuit
made
clear that “a claim must be read in view of the specification of which it is a part.”
Id.
Indeed, it would be inappropriate for this Court to construe “effective amoun
t of
zolpidem” in Claims 1 and 12, as if these claims stood apart from the ‘809
Patent. See id.; see
also Retractable Techs., Inc. v. Becton, Dickinson & Co., 653 F.3d 1296, 1305
(Fed. Cir. 2001)
12

(“In reviewing the intrinsic record to construe the claims,” courts should “strive to capture
the
scope of the actual invention, rather than strictly limit the scope of the claims to disclos
ed
embodiments or allow the claim language to become divorced from what the specifi
cation
conveys is the invention.”). The Federal Circuit has repeatedly made clear that a “paten
tee’s
lexicography must govern the claim construction analysis.” Braintree Laboratories,
Inc. v.
Novel Laboratories, Inc., No. 13-1438, 2014 WL 1584451, at *5 (Fed. Cir. Apr.
22, 2014); see

also Phillips, 415 F.3d at 1315 (observing that “the specification is always highly
relevant to the
claim construction analysis [and] is [u]sually.

.

.

dispositive [because] it is the single best guide

to the meaning of a disputed term.”) (internal quotation marks omitted). Here, the
patentee chose
to define “effective amount” in the ‘809 Patent. Accordingly, that definition must govern
. See
Martek, 579 F.3d at 1380.
b.

Preamble “A solid unit dosage composition for the treatment
of MOTN insomnia, said composition comprising”
—

The parties dispute whether the preamble to Claims 1 and 12 of the ‘809 Patent
is
limiting. The Federal Circuit has observed that “a preamble limits the invent
ion if it recites
essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality
to the claim.”
Catalina Mktg. Int’l v. Coo/savings, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)
(quoting Pitney
Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999))
. “Whether to treat a

preamble as a limitation is a determination ‘resolved on review of the entire[
]

.

.

.

patent to gain

an understanding of what the inventors actually invented and intended to encom
pass by the
claim.” Id. (quoting Corning Glass Works v. Sumitomo Electric US.A.,
Inc., 868 F.2d 1251,

1257 (Fed. Cir. 1996)). “[P]reambles describing the use of an invention
generally do not limit
the claims because the patentability of apparatus or composition claims
depends on the claimed
structure, not on the use or purpose of that structure.” Id. at 809.
13

Here, the crux of Defendants’ argument is that the preamble to Claims 1 and 12 is not
limiting because it merely “describes a use for the claimed composition,” namely,
to treat MOTN
insomnia. (See, e.g., CM/ECF No. 93 at 19-20.) Additionally, Defendants argue that their
position is in accord with the ‘809 Patent’s file history. Specifically, they point out
that the
patent examiner stated that “the intended use recited in [Cjlaim 1, namely that the compo
sition is
for the treatment of MOTN insomnia is not afforded patentable weight” because “a recitati
on of
an intended use of the claimed invention must result in a structural difference betwee
n the
claimed invention and the prior art in order to patentably distinguish the claimed invent
ion from
the prior art.” (Id. at 20, quoting August 18, 2011 Office Action at 4.)
Defendants’ argument that the preamble to Claims I and 12 describes a mere use of the
claimed composition is misguided for three primary reasons.
First, that the claimed composition is “for the treatment of MOTN insomnia” breathe
s life
and meaning into what an “effective amount of zolpidem” is. The compositions recited
in
Claims I and 12 provide a range, as opposed to a fixed, amount of zolpidem. A
3
person of
ordinary skill in the art must know that the claimed compositions are for treating MOTN
insomnia (rather than insomnia in a patient with difficulty falling asleep) to know
4
what specific
amount of zolpidem within the recited range would be “effective.” Accordingly,
that Claims I

The range amount of zolpidem recited in Claim 1 is one that is less than 1.30
x iO moles, and produces a plasma
concentration between 25 ng/ml and about 50 ng’ml within 20 minutes of administratio
n. The range amount recited
in Claim 12 is one that is 0.5 to 4.75 mg, and is sufficient to produce a plasma
concentration between 25 ng/ml and
about 50 rig/mi within 20 minutes of administration.
“Defendants do not dispute Plaintiffs’ expert’s assertion that zoipidem is effective
for treating conditions other than
MOTN insomnia. (See Kryger Deci. at ¶J 26-27 (describing effectiveness and
limitations of using zolpidem to treat
patients with difficulty falling asleep).) As zolpidem is effective for the treatment
of conditions other than MOTN
insomnia, it is apparent to the Court that a person of ordinary skill in the
art must know what condition the
compositions claimed in Claims 1 and 12 are designed to treat. Therefore,
that the claimed compositions are “for
the treatment of MOTN insonmia” is instructive for determining the amount of
zolpidem that would be effective.

14

and 12 recite a composition “for the treatment of MOTN insomnia” does not merely describ
ea
use of the invention, but breathes life into the meaning of “effective amount of zolpidem,”
and
thus amounts to a limitation. See, e.g., Vizio, Inc. v. Int’l Trade Comm ‘n, 605 F.3d 1330,
1340
(Fed. Cir. 2010) (holding that the preamble phrase “apparatus for decoding” in a produc
t claim
was “properly construed as a claim limitation, and not merely a statement of purpose or intend
ed
use for the invention, because ‘decoding’ [was] the essence or a fundamental characteristic
of the
claimed invention.”).
Second, the preamble to Claims I and 12 sets forth

the claimed compositions should

be structured, that is, as “[a] solid unit dosage.” The term “solid” governs the physic
5
al state of
the composition (e.g., not a liquid or gel). Additionally, the specification’s definition of “unit
dosage” teaches a person of ordinary skill in the art that the compositions claimed in Claims
1
and 12 should be “physically discrete units suitable as unitary dosages for human subjec
ts and
other mammals, each unit containing a predetermined quantity of therapeutic agent
calculated to
produce the desired onset, tolerability, and therapeutic effects, in association with one or
more
suitable pharmaceutical excipients such as carriers.” (‘809 Patent 17:40-46.)
Third, the ‘809 Patent’s prosecution history supports the proposition that the preamb
le to
Claims I and 12 is limiting. While Defendants point to the patent examiner’s statem
ent of
August 18, 2011 suggesting that that the phrase “for the treatment of MOTN insomn
ia” is not
worthy of “patentable weight,” they overlook the fact that the patent examiner made
Lgjçj
contradictory statements. Specifically, in a March 12, 2012 office action, the
patent examiner
twice referred to the preamble as “the claim limitation that the solid unit dosage
composition is

It bears mentioning that, at oral argument, Defendants all but conceded that “[a]
solid unit dosage composition” is
limiting, Specifically, Defendants acknowledged that “solid dosage form has more
of a structural flavor to it,” and
suggested that this portion of the preamble can be “parsed out” for claim constru
ction purposes. (Tr. 50:8-10, 15.)

15

for the treatment of MOTN insomnia.” (See ‘809 File History, March 12, 2012 Office Action
, at
TRANSIZ0006O691, TRANSIZ0006O694 (emphasis added).) In any event, nothing in
the
record suggests that Plaintiffs ever acquiesced to the patent examiner’s characterizati
on of the
phrase, “for the treatment of MOTN insomnia,” in the statement of August 18, 2011.
Therefore,
this statement has no bearing on whether the preamble to Claims I and 12 is limiting.
See, e.g.,
3Mlnnovative Props. Co. v. Avery Dennison Corp., 350 F.3d 1365, 1373-74 (Fed.
Cir. 2003)

(“An applicant’s silence in response to an examiner’s characterization of a claim does
not reflect
on the applicant’s clear and unmistakable acquiescence to that characterization if the
claim is
eventually allowed on grounds unrelated to the examiner’s unrebutted characterizati
on.”).
For these reasons, this Court holds that the preamble to Claims I and 12 is limiting.
C.

“Buffer”

“Buffer” appears in Claim 1 of the ‘628 Patent. This claim states the following:
Claim 1: A method for treating insomnia, comprising the
steps of: administering a solid pharmaceutical composition
comprising zolpidem or a pharmaceutically acceptable sale
thereof to a subject prone to insomnia, the pharmaceutical
composition further comprising a buffer, wherein the buffer
raises the pH of saliva to a pH of about 7.8 or greater,
wherein zolpidem is absorbed across a permeable
membrane of the subject’s oral mucosa, and wherein at
least 75% of the solid pharmaceutical composition
dissolves within 10 minutes or less within an oral cavity
following administration.
Plaintiffs argue that “buffer” should be construed in accordance with its plain
and
ordinary meaning. Alternatively, Plaintiffs maintain that “buffer” should
be construed as “at
least one substance used to maintain an approximate pH range.” According
to Defendants,
“buffer” should be construed to mean “a buffer system of two or more bufferi
ng agents.”

16

At the heart of the parties’ dispute is whether a “buffer,” as used in Claim 1 of the ‘628
Patent, can be limited to

one substance. Defendants argue that the intrinsic evidence

demonstrates that Plaintiffs have disavowed any notion that “buffer,” as used in Claim
1 of the
‘628 Patent, may consist of only one substance. Plaintiffs, on the other hand, argue
that the
Court should adopt their proposed construction because it is faithful to the plain
and ordinary

meaning of “buffer.” Plaintiffs further argue that Defendants proposed construction improp
erly
limits the full-scope of the meaning of “buffer.”
The Court acknowledges that in the ordinary sense of the word, a “buffer” may consis
t of
a single substance. See, e.g., Oxford Dictionary of Biochemistry and Molecular Biolog
y
(Revised Ed. 2000) (defining “buffer” as “any substance or mixture of substances that,
when
dissolved (usually in water) will maintain its solution at approximately constant
pH despite small
additions of acid or base.”) (emphasis added). Nevertheless, the Court’s task is not
to determine
the ordinary meaning of a “buffer.” Rather, the Court must construe “buffer” in
light of the ‘628
Patent specification. See, e.g., United States v. Adams, 383 U.S. 39, 49 (1966) (“[Cjla
ims are to
be construed in light of the specification and both are to be read with a view to ascerta
ining the
invention.”).
The ‘628 Patent specification describes how the patented invention is differe
nt from other
inventions that use single-agent buffers and describes the limitations of singleagent buffers.
While recognizing that other “transmucosal dosage forms include the use
of a single buffering
agent in order to change.

.

.

pH,” (‘628 Patent 2:43-44), the specification describes why the use

of single buffering agents has its limitations in achieving a certain pH. Specif
ically, the
specification states:
[Sjingle buffering agents typically react with an acid or a base to
create a final pH that is dependent upon the initial pH of the saliva
17

of the user. A buffering agent used to attain a final pH that is
dependent upon the initial pH of the user results in great
variability. The extent of ionization, and hence the extent of
absorption across the mucous membranes cannot be predicted with
any sort of accuracy. This may pose significant problems when
calculating precise doses, minimizing variability in patient
response, and proving consistency in drug loading to the regulatory
authorities. In addition, a single buffering agent is typically not
capable ofsustaining a given pH over a period of time for optimal
absorption.
(628 Patent 2:45-56 (emphasis added).)
The specification then goes on to describe the genius of the invention covere
d by the ‘628
Patent, that is, a “buffer system [that] raises the pH of saliva to a pH greater
than about 7.8,
thereby facilitating the substantially complete conversion of the hypnotic
agent from its ionized
form to its un-ionized form.” (‘628 Patent at 3:32- 35 (emphasis added).)
Examples of such a
buffer system include a “binary buffer system,” a “ternary buffer system”
and a “buffer system
comprising two or more buffering agents.” (‘628 Patent at 3:56, 4:29, 43,
56.) Notably, none of
the buffer system embodiments described in the ‘628 Patent include a single
buffering agent.
Plaintiffs point to the following language of the ‘628 Patent specification
to suggest that
any criticism of single-agent buffers is of no moment because the specification
also criticizes
certain multi-component buffers:
While others in the art have disclosed the use of more than one
buffering agent, these aforementioned problems are not easily
cured by the nonchalant addition of an extra buffering agent, which
may be unsafe and cause irreversible damage to the mucous
membranes of the oral cavity. As such, a buffering system capable
of achieving and sustaining a final pH independent of the initial pH
in order to increase transmucosal absorption has not heretofore
been demonstrated.

18

(‘628 Patent at 2:56-64.) Plaintiffs’ argument fails to persuade the Court because
the logical
inference from this passage is that the patented invention is different from,
and superior to,
single-agent buffers and certain multi-component buffers.
The Court is mindful that the Federal Circuit has held that “[m)ere criticism
of a
particular embodiment encompassed in the plain meaning of a claim term is not suffici
ent to rise
to the level of clear disavowal.” Thorner v. Sony Computer Entm ‘tAm., LLC,
669 F.3d 1362,
1366 (Fed. Cir. 2012). The Court is also mindful that the Federal Circuit has
“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.” Phillips, 415 F.3d at 1323;
see also Thorner,
669 F.3d at 1366 (“It is likewise not enough [to rise to the level of a disavowal)
that the only
embodiments, or all of the embodiments, contain a particular limitation.”). Nevert
heless, “the
goal of claim construction is to determine what an ordinary artisan would
deem the invention
claimed by the patent, taking the claims together with the rest of the specifi
cation.” Astrazeneca
AR v. Mut. Pharm. Co., 384 F.3d 1333, 1337 (Fed. Cir. 2004).
Here, the inventor did more than merely criticize the use of single-bufferi
ng agents in the
specification. Indeed, the inventor specifically stated that such singlebuffering agents are
“typically not capable of sustaining a given pH over a period of time
for optimal absorption.”
(‘628 Patent at 2:55-56.) The patentee then disclosed various buffer
systems that are capable of
achieving this desired result. Notably, all such buffer systems include
two or more buffering
agents. Construing “buffer” in light of the specification, as this Court
must, compels the
conclusion that the inventor never intended for “buffer” to encom
pass only a single agent. See,
e.g., Phillips, 415 F.3d at 1316 (“[T]he inventor’s intention, as expres
sed in the specification, is
regarded as dispositive.”); Alloc, Inc. v. Int’l Trade Comm ‘n, 342
F.3d 1361, 1370 (Fed. Cir.
19

2003) (“[W]here the specification makes clear at various points that the claime
d invention is
narrower than the claim language might imply, it is entirely permissible and
proper to limit the
claims.”); see also Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998)
(construing a
patent as “disclos[ing] only conical shaped cups and nothing broader” where
“the only reference
in the.

.

.

specification to different shapes is a recitation of prior art,” and the specification

“specifically distinguishes prior art as inferior and touts the advantages of
the conical shape of
the [patented invention].”) (emphasis in original).
Plaintiffs raise four main arguments in support of their proposed construction,
none of
which are persuasive.
First, Plaintiffs argue that Claim 9, which depends from Claim 1, demonstrates
that

“buffer” is not limited to two or more substances. (See, e.g., CM/ECF
No. 95 at 29.) Claim 9
states, “The method of claim 1, wherein the buffer comprises a carbonate
buffer and a
bicarbonate buffer.” (‘628 Patent, ci. 9.) According to Plaintiffs, that Claim
9 limits the buffer
to embodiments with at least two substances, each of which is referred
to as a “buffer,”
demonstrates that “a person having ordinary skill in the art would unders
tand that the ‘buffer’ in
Claim I may include a single substance.” (CM/ECF No. 95 at 29.)
Plaintiffs’ argument is misplaced. There is no dispute that the “buffer”
of Claim 9 refers
to the “buffer” of Claim 1, and describes it as comprising two substances—a
carbonate buffer
and a bicarbonate buffer—which together form the “buffer” of Claim
1, incorporated by
reference into Claim 9. Thus, while Claim 9 demonstrates that a
“buffer” may include two
substances, nothing in Claim 9 (or anywhere else in the ‘628 Patent)
suggests that a “buffer” may
refer to a single substance.

20

Second, Plaintiffs argue that the ‘628 Patent’s incorporation by reference of
U.S.
Provisional Patent Application No. 60/608,957 (the “957 Application”)
supports their proposed
construction of “buffer.” The ‘957 Application states that “[i]n some
variations, the buffer
system comprises a single buffering agent.

.

.

.

However, any number of buffering agents may be

used as practicable, so long as the buffering system achieves the final pH.”
(‘957 Application at

¶ [0047].)

The ‘628 Patent incorporates the ‘957 Application by reference with
the following

language:
CROSS-REFERENCES TO RELATED APPLICATIONS
This is a continuation of U.S. application Ser. No. 11/060,641,
filed Feb. 16, 2005, which claims priority to U.S. Provisional
Application No. 60/608,957 (converted from U.S. application Ser.
No. 10/783,118), filed Feb. 17, 2004, and U.S. Provisional
Application No. 60/598,629, filed Aug. 3, 2004, each of which is
herein incorporated by reference in its entirety for all purposes.
(‘628 Patent at 1:5-14.)
Notably, the ‘628 Patent does not describe with particularity the portion
of the ‘957
application it incorporates by reference. Thus, Plaintiffs may not point
to boilerplate language in
the ‘628 Patent to argue that the ‘957 application is incorporated
by reference in its entirety. See,
e.g., Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272,
1282 (Fed. Cir. 2000) (“To
incorporate material by reference, the host document must identif
y tJ detailed particularity
what specific material it incorporates and clearly indicate where
the material is found in the
various documents.”) (citing cases); see also SkinMedica, Inc. v.
Histogen, 727 F.3d 1187, (Fed.
Cir. 2013) (observing that textbook which patent purported to incorp
orate by reference was not
helpful to claim construction analysis because the inventor did not
“refer with any detailed
particularity to the passages in [the textbook]” which the plainti
ff claimed supported the
plaintiff’s proposed construction of a disputed term).

21

Third, Plaintiffs argue that the use of the term “buffer” in the claims of
the ‘945 Patent,

the parent of the ‘628 Patent, refutes Defendants’ proposed construction.
Specifically, Plaintiffs
maintain that when the patentee sought to claim a buffer comprising
two or more substances, it
did so expressly in the ‘945 Patent whose claims are “limited to metho
ds using multiple-buffer
formulations.” (See, e.g., CM/ECF No. 95 at 30-31.)
Plaintiffs argument is unavailing because, when construed in light
of the specification, it
is apparent that Claim I of the ‘628 Patent recites a broader universe
of buffers than the ‘945
Patent. The ‘945 Patent discloses a very specific type of binary buffer
(i.e., one comprised of a
carbonate buffer, and a bicarbonate buffer). (See ‘945 Patent, ci.
1, 14.) The “buffer” recited in
Claim I of the ‘628 Patent, by contrast, is not limited to a carbonate buffer
and a bicarbonate
buffer as evidenced by the fact that when the patentee sought to
so limit a “buffer” in the ‘628
Patent, it did so in Claim 9. Indeed, when read in light of the specifi
cation, it is clear that the
“buffer” recited in Claim 1 may refer to a “binary buffer system compr
ising a carbonate salt and
a bicarbonate salt,” (see, e.g., ‘628 Patent at 3:56-57), a “ternary buffer
system comprising a
carbonate salt, a bicarbonate salt, and a third buffering agent,” (see,
e.g., id. at 4:43-44), or a
“binary buffer system comprising a metal oxide and a citrate, phosph
ate, or borate salt,” (see,
e.g., id. at 4: l617).6 Nothing in the specification, however, suppor
ts Plaintiffs’ argument that a
“buffer” may refer to a single substance.
Fourth, Plaintiffs argue that the prosecution history of the
‘628 Patent supports their

proposed construction. Specifically, they argue that “[djuring prosec
ution, the applicant pursued
two separate independent claims—one reciting “a buffer,” and
the other reciting “a binary

6

These examples are not intended to serve as an exhaustive list
of what a “buffer” may refer to in the ‘628 Patent.
The Court merely intends to illustrate why “buffer,” as used
in the ‘628 Patent, has a broader meaning than “buffer”
as used in the ‘945 Patent.

22

buffer.” (CM/ECF No. 95 at 30 (citing ‘628 File History, October 17, 2008 Amendment and
Response at TRANSIZ00058934, TRANSIZ00058937).) Therefore, according to Plaintiffs, “the
applicant clearly considered that the ‘buffer’ of Claim 1 need not be ‘binary.” (CM/ECF No. 95
at 24.)
While the Court agrees that the “buffer” recited in Claim 1 need not be binary, nothing in
the record suggests that the October 17, 2008 Amendment and Response was intended to claim a
single buffering agent. The October 17, 2008 Amendment and Response, which added the
“buffer” limitation to Claim I of the ‘628 Patent, states that “support for these amendments can
be found in the specification at, e.g., paragraphs 038, 042, 101, 133, and 203.” (‘628 File
History, October 17, 2008 Amendment and Response at TRANSIZ0005894O.) These
paragraphs, in turn, refer to a “buffer system,” (Michniak-Kohn Dccl., Ex. 10 at 0042, 0101)
¶J
and a “binary or ternary buffer system,” (Michniak-Kohn Dccl., Ex. 10 at 0133.) None of the
¶
citations to the specification in the October 17, 2008 Amendment and Response support
Plaintiffs’ contention that a “buffer” may comprise

a single substance.

In light of the specification and the prosecution history of the ‘628 Patent, this Court will
adopt Defendants’ proposed construction for “buffer.”
D.

“Buffering agent”

“Buffering agent” appears in Claim 12 of the ‘809 Patent, the text of which is set forth in
Section 11I.B, supra. Plaintiffs maintain that the Court should construe “buffering agent”
as “a
proton-donating component or proton-accepting component used to maintain and/or
achieve an
approximate pH range.” Defendants’ proposed construction is similar—”a proton-donat
ing
component or a proton-accepting component that changes pH.”

Paragraphs 038 and 203 do not reference buffers, buffering agents, or buffering systems
at all.

23

The primary dispute between the parties is whether a buffering agent

changes pH.

In their briefs, Defendants acknowledge that controlling (or maintaining)
pH is one function of a
buffering agent. (CM/ECF No. 103 at 26 (recognizing that “control[ling]
the pH of a solution” is
“another function of a buffering agent”).) Additionally, Defendants’
own expert, Dr. Bozena B.
Michniak-Kohn has recognized that a “buffering agent must assist in
maintaining the pH of
saliva within [an] approximate range.” (Michniak-Kohn Deci. at 43.)
Yet, Defendants’
¶
proposed construction fails to encapsulate the pH-maintaining charac
teristic of a buffering agent.
Plaintiffs’ proposed construction, however, embraces both the pH-ma
intaining and pH-adjusting
characteristics of a “buffering agent.” Accordingly, the Court adopts
Plaintiffs’ proposed
construction.
E.

“Binary buffer system”

“Binary buffer system” appears in Claims 5, 6, 22, 23 of the ‘809 Patent
. These claims
State the following:
Claim 5: The solid unit dosage composition of claim 1, further
comprising a binary buffer system that raises the pH of said
subject’s saliva to a pH greater than about 8.5, irrespective of
the
starting pH of saliva.
Claim 6: The solid unit dosage of claim 5, wherein the binary
buffer system consists of sodium carbonate and sodium
bicarbonate.
Claim 22: The solid unit dosage composition of claim 12, further
comprising a binary buffer system that raises pH of said subjec
t’s
saliva to a pH greater than about 8.5, irrespective of the starting
pH
of saliva.
Claim 23: The solid unit dosage composition of claim 22, wherei
n
the binary buffer system consists of sodium carbonate and sodium
bicarbonate.

24

Plaintiffs and Defendants’ respective proposed constructions are nearly
identical.
Plaintiffs maintain that “binary buffer system” should be construed
to mean “a system used to
maintain and/or achieve an approximate pH range comprising of at
least one proton-donating
component and at least one proton-accepting component.” Defend
ants’ proposed construction,
on the other hand, is “a system used to achieve and maintain an approx
imate pH range consisting
of one proton-donating component and one proton-accepting compo
nent.” The only difference
between the proposed constructions is that Plaintiffs use the word
“comprising” while
Defendants use “consisting of.”
“In the patent claim context the term ‘comprising’ is well unders
tood to mean ‘including
but not limited to.” Cias, Inc. v. Alliance Gaming Corp., 504 F.3d
1356, 1360 (Fed. Cir. 2007).
“It is equally well understood in patent usage that ‘consisting of’ is
closed-ended and conveys
limitation and exclusion.” Id. at 1361. Thus, “it is clear that ‘comp
rise’ is broader than
‘consist.” Georgia-Pacific Corp. v. United States Gypsum Co.,
195 F.3d 1322, 1327-28 (Fed.

Cir. 1999).
Here, the ‘809 Patent specification clearly supports a broader constru
ction of “binary
buffer system.” In relevant part, the specification defines
“a binary or ternary buffer system” as
a “system comprised of at least one proton donating (acidic)
component and at least one proton
accepting (basic) component.” (‘809 Patent at 26:62-65 (emph
asis added).) The use of the
words “comprised of” and “at least” in the definition makes
clear that a binary buffer system
may include more than just one proton-donating component
and more than just one proton
accepting component. Plaintiffs’ proposed construction
for “binary buffer system” mirrors the
language of the specification in that it includes the words
“comprised of’ and “at least.”
Defendants’ proposed construction, on the other hand, seeks
to limit the definition of binary
25

buffer system to include jy one proton donating component and
one proton accepting
component. The specification’s language does not support such
a limitation.
As Plaintiffs’ proposed construction for “binary buffer system
” mirrors the language of
the specification, the Court adopts Plaintiffs’ proposed construct
ion. See Phillips, 415 F.3d at
1315; Martek, 579 F.3d at 1380.
IV.

CONCLUSION

For the foregoing reasons, the Court construes the disputed term
s as follows:
1. The term “without residual sedative effects,” as used in Clai
ms I and 12 of the ‘131
Patent is construed to mean “with no or minimal subjective feeli
ngs of sedation, as
evaluated by: (a) testing acceptably in at least one test
exploring psychomotor
performance, attention, information processing, and memory
used by those of skill
in the art; and/or (b) demonstrating plasma levels of zolpidem
, at an appropriate
time point, below about 29 ng/ml.
2. The term “effective amount of zolpidem” as used in Clai
ms 1 and 12 of the ‘809
Patent is construed to mean “amount of zolpidem that is capa
ble of achieving a
therapeutic effect in a subject in need thereof.”
3. The Preamble to Claims 1 and 12 of the ‘809 Patent—”a solid
unit composition for
the treatment of MOTN insomnia, said composition com
prising”—is construed as
limiting.
4. The term “buffer,” as used in Claim 1 of the ‘628 Patent
, is construed to mean “a
buffer system of two or more buffering agents.”
5. The term “buffering agent,” as used in Claim 12 of the
‘809 Patent, is construed to
mean “a proton-donating component or proton-accepti
ng component used to
maintain and/or achieve an approximate pH range.”
6. The term “binary buffer system,” as used in in Claims
5, 6, 22, and 23 of the ‘809
Patent is construed to mean “a system used to main
tain and/or achieve an
approximate pH range comprising at least one proton-do
nating component and at
least one proton-accepting component.”
An appropriate order follows.

26

____

Dated:

of June, 2014.

JNARES
.S. DISTRICT JUD

27