Harcol Research LLC v Europa Sports Products Inc

Filing 208

MEMORANDUM OPINION AND ORDER. Signed by Magistrate Judge Roy S. Payne on 11/03/2014. (nkl, )

THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
MARSHALL DIVISION
HARCOL RESEARCH, LLC,
Plaintiff,
v.
EUROPEA SPORTS PRODUCTS, INC.,
D/B/A EUROPEA SOUTHWEST DC,
Defendant.

§
§
§
§
§
§
§
§
§
§
§

CASE NO. 2:13-CV-228-JRG-RSP
LEAD CASE

MEMORANDUM OPINION AND ORDER
Before the Court is the opening claim construction brief of Plaintiff Harcol Research,
LLC (Dkt. No. 191, filed on July 22, 2014), the response of Defendants Europa Sports Products,
Inc., Bio-Engineered Supplements & Nutrition, Inc., HBS International Corp., Joe Wells
Enterprises, Inc. d/b/a Max Muscle Sports, Nutrex Research, Inc., SAN Nutrition Corp., Lone
Star Distribution and Ultimate Nutrition, Inc. (collectively, “Defendants”) (Dkt. No. 195, filed on
August 5, 2014), and the reply of Plaintiff (Dkt. No. 197, filed on August 12, 2014). The Court
held a claim construction hearing on September 18, 2014. Having considered the arguments and
evidence presented by the parties at the hearing and in their claim construction briefing, the
Court issues this Claim Construction Order.

1

Table of Contents
I. BACKGROUND ....................................................................................................................... 3 
II. LEGAL PRINCIPLES ........................................................................................................... 4 
III. CONSTRUCTION OF AGREED TERMS ........................................................................ 8 
IV. CONSTRUCTION OF DISPUTED TERMS ..................................................................... 8 
A.  “large and rapid energy supply” ........................................................................................... 8 
B.  “providing an energy source” ............................................................................................. 15 
C.  “healthy mammal” .............................................................................................................. 19 
D.  “a beverage, or a dry composition thereof” ........................................................................ 24 
E.  “comprising 0.1 to 2.5 percent of the wet weight of α-ketoglutaric acid”.......................... 26 
F.  “water-soluble innocuous salt thereof” ............................................................................... 30 
G.  “wherein α-ketoglutaric acid is combined with malic acid” ............................................... 35 
IV. CONCLUSION .................................................................................................................... 39 

2

I. BACKGROUND
Plaintiff alleges infringement of United States Patent No. 5,817,364 (“the ‘364 patent”) in
this lawsuit. The application leading to the ‘364 patent is based on a PCT application filed on
November 8, 1994, which is based on an application filed in Sweden on November 9, 1993. The
‘364 patent issued on October 6, 1998, and is entitled “Beverage Containing Alpha-Ketoglutaric
Acid and Method of Making.” In general, the ‘364 patent is directed to an energy beverage that
comprises α-ketoglutaric acid, or a water-soluble innocuous salt thereof, for situations which
demand a large and rapid energy supply to a healthy mammal. The Abstract of the ‘364 patent
states:
The present invention is related to an energy supply composition particularly
suitable for use before, during and after physical exertion. The composition is a
beverage, or a dry composition therefore, useful as an energy source in situations
which demand a large and rapid energy supply to a healthy mammal including
man. The beverage comprises an effective amount of alpha-ketoglutaric acid or a
water-soluble innocuous salt thereof together with a nutritionally acceptable
water-soluble carrier.
Representative claims of the ‘364 patent are shown below:
1. A beverage, or a dry composition therefor, providing an energy source in
situations with demand of large and rapid energy supply to a healthy mammal
comprising 0.1 to 2.5 percent of the wet weight of α-ketoglutaric acid or a watersoluble innocuous salt thereof together with a nutritionally acceptable watersoluble carrier.
2. A beverage, or a dry composition therefor, according to claim 1, wherein αketoglutaric acid is combined with malic acid.
7. A method of large and rapid energy supply to a healthy mammal, comprising
providing to said animal, a beverage, or a dry composition therefor, comprising
0.1 to 2.5 percent of the wet weight of α-ketoglutaric acid or a water-soluble
innocuous salt thereof together with a nutritionally acceptable water-soluble
carrier.

3

Of relevance to this opinion and the parties’ dispute as to certain terms of the ‘364 patent,
previous defendant USPlabs, LLC filed a request for inter partes reexamination with the Patent
Trial and Appeal Board (“PTAB”) on July 12, 2013 on claims 1-7 of the ‘364 patent. (See, e.g.,
Exh. 191-5 at 921-974.) On November 15, 2013, the PTAB denied the petition to institute an
inter partes reexamination and found that “USPlabs has not shown that there is a reasonable
likelihood that it will prevail with respect to at least one of the challenged claims, and the
petition is denied.” (See USPlabs, LLC v. Harcol Res., LLC, No. IPR2013-00399, 1 (P.T.A.B.
Nov. 15, 2013) (“PTAB Opinion”), found at Dkt. No. 191-5 at 990-1000.) The PTAB Opinion is
relevant to both parties’ claim construction arguments.

II. LEGAL PRINCIPLES
“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. AWH Corp., 415 F.3d 1303,
1312 (Fed. Cir. 2005) (en banc) (quoting Innova/Pure Water Inc. v. Safari Water Filtration Sys.,
Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). To determine the meaning of the claims, courts start
by considering the intrinsic evidence. See id. at 1313; see also C.R. Bard, Inc. v. U.S. Surgical
Corp., 388 F.3d 858, 861 (Fed. Cir. 2004); Bell Atl. Network Servs., Inc. v. Covad Commc’ns
Group, Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001). The intrinsic evidence includes the claims
themselves, the specification, and the prosecution history. See Phillips, 415 F.3d at 1314; C.R.
Bard, 388 F.3d at 861. Courts give claim terms their ordinary and accustomed meaning as
understood by one of ordinary skill in the art at the time of the invention in the context of the
entire patent. Phillips, 415 F.3d at 1312-13; accord Alloc, Inc. v. Int’l Trade Comm’n, 342 F.3d
1361, 1368 (Fed. Cir. 2003).

4

The claims themselves provide substantial guidance in determining the meaning of
particular claim terms. Phillips, 415 F.3d at 1314. First, a term’s context in the asserted claim
can be very instructive. Id. Other asserted or unasserted claims can aid in determining the
claim’s meaning because claim terms are typically used consistently throughout the patent. Id.
Differences among the claim terms can also assist in understanding a term’s meaning. Id. For
example, when a dependent claim adds a limitation to an independent claim, it is presumed that
the independent claim does not include the limitation. Id. at 1314-15.
“[C]laims ‘must be read in view of the specification, of which they are a part.’” Phillips,
415 F.3d at 1315 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir.
1995) (en banc)). “[T]he 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.’”
Id. (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)); accord
Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002). This is true because
a patentee may define his own terms, give a claim term a different meaning than the term would
otherwise possess, or disclaim or disavow claim scope. Phillips, 415 F.3d at 1316. In these
situations, the inventor’s lexicography governs. Id. The specification may also resolve the
meaning of ambiguous claim terms “where the ordinary and accustomed meaning of the words
used in the claims lack sufficient clarity to permit the scope of the claim to be ascertained from
the words alone.” Teleflex, 299 F.3d at 1325. But, “[a]lthough the specification may aid the
court in interpreting the meaning of disputed claim language, particular embodiments and
examples appearing in the specification will not generally be read into the claims.” Comark
Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998) (quoting Constant v.

5

Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571 (Fed. Cir. 1988)); accord Phillips, 415 F.3d
at 1323.
The prosecution history is another tool to supply the proper context for claim
construction because a patent applicant may also define a term in prosecuting the patent. Home
Diagnostics, Inc., v. Lifescan, Inc., 381 F.3d 1352, 1356 (Fed. Cir. 2004) (“As in the case of the
specification, a patent applicant may define a term in prosecuting a patent.”). “[T]he prosecution
history (or file wrapper) limits the interpretation of claims so as to exclude any interpretation that
may have been disclaimed or disavowed during prosecution in order to obtain claim allowance.”
Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 452 (Fed. Cir. 1985).
Although extrinsic evidence can be useful, it is “less significant than the intrinsic record
in determining the legally operative meaning of claim language.” Phillips, 415 F.3d at 1317
(citations and internal quotation marks omitted). Technical dictionaries and treatises may help a
court understand the underlying technology and the manner in which one skilled in the art might
use claim terms, but technical dictionaries and treatises may provide definitions that are too
broad or may not be indicative of how the term is used in the patent. Id. at 1318. Similarly,
expert testimony may aid a court in understanding the underlying technology and determining
the particular meaning of a term in the pertinent field, but an expert’s conclusory, unsupported
assertions as to a term’s definition are entirely unhelpful to a court. Id. Generally, extrinsic
evidence is “less reliable than the patent and its prosecution history in determining how to read
claim terms.” Id.
The “determination of claim indefiniteness is a legal conclusion that is drawn from the
Court’s performance of its duty as the construer of patent claims.” Exxon Research & Eng’g Co.

6

v. United States, 265 F.3d 1371, 1375 (Fed. Cir. 2001). Section 112 entails a “delicate balance”
between precision and uncertainty:
On the one hand, the definiteness requirement must take into account the inherent
limitations of language. Some modicum of uncertainty, the Court has recognized,
is the price of ensuring the appropriate incentives for innovation. … At the same
time, a patent must be precise enough to afford clear notice of what is claimed,
thereby apprising the public of what is still open to them. Otherwise there would
be a zone of uncertainty which enterprise and experimentation may enter only at
the risk of infringement claims. And absent a meaningful definiteness check, we
are told, patent applicants face powerful incentives to inject ambiguity into their
claims. … Eliminating that temptation is in order, and the patent drafter is in the
best position to resolve the ambiguity in patent claims.
Nautilus Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2128-29 (2014) (citations omitted).
Therefore, in order for a patent to be definite under § 112, ¶2, “a patent’s claims, viewed in light
of the specification and prosecution history, [are required to] inform those skilled in the art about
the scope of the invention with reasonable certainty.” Id. at 2129. The determination of
“definiteness is measured from the viewpoint of a person skilled in the art at the time the patent
was filed.” Id. at 2128. (emphasis original, citations omitted). “The definiteness requirement . . .
mandates clarity, while recognizing that absolute precision is unattainable.” Id. This standard
reflects rulings that have found that “the certainty which the law requires in patents is not greater
than is reasonable, having regard to their subject-matter.” Id. at 2129. “Whether a claim
reasonably apprises those skilled in the art of its scope is a question of law that [is] review[ed] de
novo.” Microprocessor Enhancement Corp. v. Texas Instruments Inc., 520 F.3d 1367, 1374
(Fed. Cir. 2008). As it is a challenge to the validity of a patent, the failure of any claim in suit to
comply with § 112 must be shown by clear and convincing evidence. Nautilus, 134 S. Ct. at
n.10.

7

III. CONSTRUCTION OF AGREED TERMS
The Court notes the following agreed constructions:
Term

Agreed Construction

“nutritionally acceptable water-soluble
carrier” (claims 1, 5, 7)
“providing to” (claim 7)

Plain and ordinary meaning.
Plain and ordinary meaning.

(Dkt. No. 181, 06/10/2014 Joint Claim Construction and Prehearing Statement.)

IV. CONSTRUCTION OF DISPUTED TERMS
The parties’ positions and the Court’s analysis as to the disputed terms are presented
below.
A. “large and rapid energy supply”
Term

Plaintiff’s
Proposed Construction

“large and rapid
energy supply”

This isolated term should be given its plain and ordinary
meaning. In context, it should be construed as indicated
above, see “providing an energy source in situations with
demand of large and rapid energy supply to a healthy
mammal (Claim 1)” and “method of large and rapid
energy supply to a healthy mammal (Claim 7).”
Athletic performance.

(claims 1 and 7)
“situations with
demand of large
and rapid energy
supply”

Defendants’
Proposed
Construction
Indefinite.

Indefinite.

See “providing an energy source in situations with
demand of large and rapid energy supply to a healthy
mammal (Claim 1)” above.

(claim 1)
The disputed term “large and rapid energy supply” appears in claims 1 and 7 of the ‘364
patent, but is used in very different ways in each. The phrase “situations with demand of large

8

and rapid energy supply” appears in only claim 1 of the ‘364 patent. The phrase “a method of
large and rapid energy supply” appears only in claim 7.
(1) The Parties’ Positions
Plaintiff submits that these phrases are not indefinite because they can be understood by
one of ordinary skill in the art. (See, e.g., Dkt. No. 191 at 14-15.) Plaintiff argues that they are
not indefinite because the USPTO never found they were indefinite during prosecution and the
petition for inter partes review. (Id.) For the “large and rapid energy supply” term, the Plaintiffs
argue that it simply carries its plain and ordinary meaning. (Id. at 14.) For the “situations with
demand of large and rapid energy supply” term, the Plaintiffs argue the specification implies that
the term means “athletic performance.” (Id. at 15.)
Defendants responds that a person of ordinary skill in the art would not know what a
“large and rapid energy supply” is in this context, there is no standard meaning for this term, and
there is no meaning to this term provided in the intrinsic record. (See, e.g., Dkt. No. 195 at 6-7.)
Defendants argue that “large” can have several meanings and there is no indication in the
specification or the prosecution history what is the intended meaning in the claims of the ‘364
patent. (Id. at 7.) Defendants argue that “large” can refer to the amount or quantity of energy in
comparison to another amount or quantity of energy, or it can refer to the amount of time for
which an energy supply is required; however, the specification does not provide any guidance as
to which meaning applies or the relevant quantities of time or energy. (Id.) Defendants also
argue that a person of ordinary skill in the art at the relevant time would surmise that the phrase
“rapid energy supply” would have multiple possible meanings depending upon whether it refers
to how rapidly the energy is utilized or how rapidly the energy is stored. (Id. at 9.) Defendants
argue that the distinction between these two possible meanings is significant because they are

9

opposites - if the phrase means rapidly utilizing, then the energy is consumed quickly, but if the
phrase means rapid storage, then the energy is not consumed. (Id.) Defendants further argue
that the specification makes the term even more ambiguous because it refers to both rapid energy
utilization and rapid energy storage. (Id.) Further, Defendants argue that one of ordinary skill
would not recognize the claimed beverage as providing a large and rapid energy supply, since
what may be a “large” or “rapid” energy supply for one functionality of α-ketoglutaric acid may
not be “large” or “rapid” for another functionality. (Id. at 10-11.)
Plaintiff replies that the phrase “large and rapid energy supply” in context means one that
will provide energy before, during, and after physical exertion. (See, e.g., Dkt. No. 197 at 3.)
Plaintiffs argues that to a person having ordinary skill in the art, a “large . . . energy supply” is
the amount of energy needed to participate in physical exertion or stressful physical exercise on a
daily basis. (Id. at 4.) Plaintiffs argue that to a person having ordinary skill in the art, the “rapid
energy supply” term means “energy supplied as it is needed during physical exertion, or in order
to engage in stressful physical exercise.” (Id. at 4.) Plaintiff argues that the term “rapid” is
comparative referring to how soon the invention acts after consumption. (Id. at 4-5.) Plaintiff
argues that, as a whole, the disputed term “large and rapid energy supply” means that the amount
of energy supplied via the α-ketoglutaric acid is the amount necessary to perform physical
exertion or stressful physical exercise, such as a six-kilometer run, 50-60 sit-ups or 30-40
pushups—and is rapid in that, having drank the beverage daily, the body was able to respond to
the physical exertion or physical exercise quickly. (Id. at 5.)
(2) Analysis
The specification provides various references to the “science” of metabolism and how the
alpha-ketoglutaric acid of the claimed invention allegedly operates. The ‘364 patent teaches that

10

the “present invention is related to an energy supply composition particularly suitable for use
before, during, and after physical exertion.” (‘364 patent, col. 1, ll. 6-8.) Other portions of the
specification also teach that the disclosed beverage provides benefits before, during, and after
physical exertion. (Id. at col. 4, ll. 65-67, col. 5, ll. 38-41, ll. 59-60.) The ‘364 patent teaches
that the invention provides both rapid energy utilization and rapid energy storage and also
provides retained endurance:
The object of the invention is to facilitate extended physical exertion by
providing energy that is efficiently utilized in mammals. A further object of the
invention is to facilitate the accretion of muscle tissue as a result of physical
training by sustaining an adequate energy status and permitting rapid build-up of
the body’s stored energy levels upon rest. A further object is to reduce the loss of
water from the body during physical exertion by retaining a high rate of water
absorption in the gastrointestinal tract from an energy rich beverage.
***
The beverage of the present invention provides energy according to the principle
of rapid energy recruitment within the organelles of the mammalian cell. An
organelle is a sub-cellular compartment representing specialized metabolic
function, such as the mitochondria were the formation of energy by oxidative
reaction in the citric acid cycle takes place. (See citric acid cycle, FIG. 2). The
main energy substrate of the said beverage, α-ketoglutaric acid, is rapidly
converted to energy or other metabolites, such as glucose, and a minimum of
metabolic waste products. Further, α-ketoglutaric acid stimulates the transport of
glucose from the blood into the muscle. The invention will thereby enhance the
performance of muscle fibres and save or replenish the indigenous energy
depot resulting in an enhanced physical and mental endurance. Also, αketoglutaric acid, a constituent in the gluconeogenesis, increases the glycogen
deposition when administered before exertion, leading to improved exercise
endurance.
α-ketoglutaric acid is formed in each cell that is active in terms of oxidative
metabolism and/or amino acid deamination reactions, and is therefore not
considered as an essential nutrient. The cells of the intestinal mucosa utilize αketoglutaric acid, derived from glutamine, as an energy substrate. This reaction
has not, until now, been considered to be limiting for an optimal intestinal
function in healthy individuals. Athletes consuming two to four times as much
calories as the untrained person, have not been thoroughly studied from such
aspect. A further advantage is provided by the invention on the intestinal function

11

exemplified by a sustained absorption efficiency during periods of large food
intake, which permits a rapid build-up of the body’s stored energy levels upon
rest.
Taken together, the improved muscle energy and water supply during physical
exertion and the sustained intestinal absorption during periods of large food
intake, make the invention facilitate the accretion of muscle tissue as a result of
physical training.
(See, e.g., ‘364 patent, col. 1, ll. 9-18; col. 5, ll. 23-63)(emphasis added). The fact that the
beverage may provide (in different situations) rapid energy utilization, rapid energy storage,
and/or retained endurance does not necessarily make the phrase “large and rapid energy supply”
contradictory or indefinite as Defendants claim.
The claim language controls, and the Court finds the patentee’s different use of the
phrase “large and rapid energy supply” in the different independent claims to be significant.
While claim 1 recites “A beverage … providing an energy source in situations with demand of
large and rapid energy supply…,” claim 7 recites “[a] method of large and rapid energy
supply…comprising providing…a beverage…” Thus, pursuant to the express claim language,
claim 7 relates to the supply of large and rapid energy through the claimed beverage itself, while
claim 1 is directed to identifying situations demanding a large and rapid energy supply (such as
physically exerting activities) in which the beverage will be used. Plaintiff’s constructions for
the different phrases in claims 1 and 7 confirm that there is a distinction in the claim language,
and during the claim construction hearing Defendants agreed that there was a difference in the
use of the disputed phrase between claims 1 and 7.
On balance, the Court finds that one of ordinary skill in the art would understand that the
recitation of “providing an energy source in situations with demand of large and rapid energy
supply” in claim 1 refers to the providing of an energy source (such as the claimed beverage) in

12

connection with physically exerting activities. Based on the language of claim 1, the energy
beverage itself is not necessarily providing a certain amount or quantity of a “large and rapid
energy supply,” but is rather being used in situations requiring such an energy supply. Based on
the specification, it is clear that the claimed beverage is to be utilized in situations demanding
significant physical exertion. (See, e.g., ‘364 patent, col. 1, ll. 6-18; col. 1, ll. 38-40; col. 3, ll.
28-38; col. 4, ll. 65-66; col. 5, ll. 59-63; col. 6, l. 64-col. 8, l. 25.) In particular, the specification
teaches that “[i]ndividuals undergoing significant physical exertion whether for athletic or other
purposes increase their nutritional needs substantially in order to maintain the body's energy
storage and to develop its muscular capacity.” (Id. at col. 1, ll. 21-24)(emphasis added.) Thus,
Defendants’ arguments related to the fact that the claimed beverage may provide in only some
situations rapid energy utilization, rapid energy storage, and/or retained endurance (but not in all
situations) does not provide any inherent conflict to the phrase “situations with demand of large
and rapid energy supply” as that concept is used in claim 1. While the Court rejects Plaintiff’s
construction of this phrase to mean merely “athletic performance,” the Court finds that the
phrase “situations with demand of large and rapid energy supply” does mean “situations
demanding significant physical exertion.”

The Court finds this is clearly and repeatedly

supported in the intrinsic record and gives sufficient clarity to the phrase and that one of ordinary
skill in the art would understand activities that require a significant amount of physical exertion
and activities that do not in the context of the ‘364 patent. Accordingly, pursuant to the Supreme
Court’s holding in Nautilus, the Court rejects Defendants’ arguments that the claim when “read
in light of the specification delineating the patent, and the prosecution history, fail[s] to inform,
with reasonable certainty, those skilled in the art about the scope of the invention.”

13

In contrast, however, the Court finds the phrase “[a] method of large and rapid energy
supply to a healthy individual…” in claim 7 to be indefinite. The Defendants provide various
arguments as to why there are multiple meanings to this phrase, why various definitions are
inconsistent, and how the meanings may change based on different situations. While the Court
does not find all of Defendants’ arguments compelling, the Court does agree with the Defendants
that there is little to no guidance as to this term in the specification. Nor do Plaintiff’s arguments
or the intrinsic support relied upon provide any significant meaning to the term “large and rapid
energy supply” by itself. The fact that the beverage may be used before, during, or after physical
activity does not necessarily mean that this phrase should be limited to all such uses or that the
beverage must be taken on a daily basis – there are no requirements in the claim language for
such limitations and to the extent Plaintiff argues such limitations, they are rejected. In contrast
to claim 1, claim 7 is clear that the beverage itself is to supply a “large and rapid energy supply,”
but it is unclear to one of ordinary skill how much that energy supply should be or what makes it
a rapid supply of energy. While the Court is hesitant to find claims indefinite, for this situation
the Court finds that, consistent with Defendant’s arguments, there is no dispute that one of
ordinary skill in the art would not understand with “reasonable certainty” the scope of the
invention and the bounds of claim 7. In particular, a person of ordinary skill in the art would not
be able to determine with reasonable certainty what “large and rapid energy supply” is in the
context of alpha-ketoglutaric acid. The intrinsic evidence is not helpful, nor are the moving
constructions and arguments provided by Plaintiff.
The Court hereby construes “situations with demand of large and rapid energy
supply” in claim 1 to mean “situations demanding significant physical exertion.”

14

The Court hereby finds “A method of large and rapid energy supply” in claim 7 to be
indefinite.

B. “providing an energy source”
Plaintiff’s
Proposed Construction
The isolated claim term should be construed in context with
claim term “providing an energy source in situations with
demand of large and rapid energy supply to a healthy mammal”
and means
“providing an energy supply composition particularly
suitable for use before, during and after physical exertion to a
healthy athlete and other healthy individual and, as applicable,
another mammal individual who is not subject to inpatient or
outpatient care for relevant conditions by a hospital or a
medical or veterinary practitioner.”

Defendants’
Proposed Construction
Indefinite. In the
alternative, plain and
ordinary meaning.

The disputed term “providing an energy source” appears in claim 1 of the ‘364 patent.
(1) The Parties’ Positions
Plaintiff submits that the term is not indefinite and should be read in context of the
surrounding claim language and not construed separately. (See, e.g., Dkt. No. 191 at 18-20.)
Defendants respond that the term is indefinite because the intrinsic evidence provides no
clear guidance on its meaning. (See, e.g., Dkt. No. 195 at 12.) Defendants argue that there is no
common understanding among those skilled in the art regarding what “providing an energy
source” means because the phrase would be understood to have multiple meanings depending
upon the type of activity being engaged in that requires an energy source. (Id.) For example,
during an intense anaerobic activity such as sprinting, the term “providing an energy source”
would be understood to mean providing glucose, specifically glucose that was previously stored
in the muscles. (Id.) Thus, for an anaerobic activity, the energy source would have to be

15

provided sufficiently in advance of the activity in order to allow for the glucose to be stored in
the muscle.

(Id.) On the other hand, for lower intensity aerobic exercises, such as long distance

running, the term “providing an energy source” would be understood to mean glucose and fat.
(Id.) Defendants argue that nothing in the patent supports a conclusion that α-ketoglutaric acid
actually provides an energy source. (Id.) While the specification describes α-ketoglutaric acid
as the main energy substrate of the claimed beverage, the claimed beverages used for the
Physical Tests contain ingredients such as glucose and fructose, which contribute to the overall
energy content of the beverage. (Id. at 12-13.) Defendants argue that one of ordinary skill in the
art would not consider the results of the Physical Tests in the ‘364 patent as evidence that the αketoglutaric acid within the claimed beverage provides an energy source. (Id. at 12.)
Plaintiff replies that, while there may not be a common understanding of this term, the
term “providing an energy source” is readily understood based on the patent’s disclosures to
mean “providing an energy supply composition particularly suitable for use before, during and
after physical exertion.” (See, e.g., Dkt. No. 197 at 5.) Plaintiff argues that its construction is
consistent with the Abstract and specification. (Id.) Plaintiff argues that it is clear that the
energy source of the invention is the composition comprising α-ketoglutaric acid. (Id.)
(2) Analysis
The disputed term “providing an energy source” appears in claim 1 of the ‘364 patent:
1. A beverage, or a dry composition therefor, providing an energy source in
situations with demand of large and rapid energy supply to a healthy mammal
comprising 0.1 to 2.5 percent of the wet weight of α-ketoglutaric acid or a
water-soluble innocuous salt thereof together with a nutritionally acceptable
water-soluble carrier.
(emphasis added.) It is clear that, in context, the claim covers a “beverage [] providing an energy
source [] comprising 0.1 to 2.5 percent of the wet weight of α-ketoglutaric acid or a water-

16

soluble innocuous salt thereof together with a nutritionally acceptable water-soluble carrier.” In
other words, the “providing an energy source …” term is further defined by the subsequent
language in the claim following “comprising.”
Defendants argue that the “providing an energy source” term is either indefinite or has its
plain meaning. Defendants’ position largely rests on the argument that nothing in the ‘364 patent
supports a conclusion that α-ketoglutaric acid actually provides an energy source. In other
words, Defendants primarily do not dispute the meaning of the term or that that it is “reasonably
certain,” rather, they merely dispute the application of that term to the claimed structures and/or
contend that the specification does not support the claim limitation. The Court finds that these
are largely written description or enablement arguments, not indefiniteness arguments. This
finding is confirmed by the fact that Defendants alternatively argue plain and ordinary meaning.
It is unclear why the Plaintiff disputes the Defendants’ plain meaning construction. While the
Plaintiff argues that the term should be construed with other disputed phrases and not construed
separately, at times the Plaintiff appears to argue a plain meaning approach and that the disputed
term is merely the claimed “composition comprising α-ketoglutaric acid.” Whether or not the
specification sufficiently enables or describes a particular claim term is a validity argument – not
a claim construction argument – and the Court will not address these separate issues at this time.1
The Court finds that the “providing an energy source” term has no special meaning other
than its plain meaning. See SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242
F.3d 1337, 1343-44 (Fed. Cir. 2001) (generally terms are presumed to possess their ordinary
meaning, although this can be overcome by statements of clear disclaimer). The Court rejects
1

Likewise, the fact that the Court provides in this opinion a construction for a disputed term or
that it holds a term has its plain meaning is not dispositive as to whether any term (construed or
not construed) is necessarily supported by the ‘364 patent.
17

Plaintiff’s argument that it needs a construction and Defendants’ argument that it is indefinite.
Further, the Court finds that the claim itself sufficiently describes the phrase a beverage
“providing an energy source” as comprising “0.1 to 2.5 percent of the wet weight of αketoglutaric acid or a water-soluble innocuous salt thereof together with a nutritionally
acceptable water-soluble carrier.” Because this resolves the dispute between the parties, the
Court finds that the term requires no further construction. See U.S. Surgical Corp. v. Ethicon,
Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997) (“Claim construction is a matter of resolution of
disputed meanings and technical scope, to clarify and when necessary to explain what the
patentee covered by the claims, for use in the determination of infringement. It is not an
obligatory exercise in redundancy.”); see also O2 Micro Int’l Ltd. v. Beyond Innovation Tech.
Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008) (“[D]istrict courts are not (and should not be) required
to construe every limitation present in a patent’s asserted claims.”) (citing U.S. Surgical, 103
F.3d at 1568).
Thus, the Court finds that there is no dispute that one of ordinary skill in the art would
understand the meaning of the term “providing an energy source” in the context of the claimed
invention. Likewise, the Court finds that there is no dispute that one of ordinary skill in the art
would understand with “reasonable certainty” the scope of the invention and the bounds of the
claims. Accordingly, pursuant to the Supreme Court’s holding in Nautilus, the Court rejects
Defendants’ arguments that the claim when “read in light of the specification delineating the
patent, and the prosecution history, fail[s] to inform, with reasonable certainty, those skilled in
the art about the scope of the invention.”
The Court hereby construes “providing an energy source” to have its plain meaning.

18

C. “healthy mammal”
Plaintiff’s
Proposed Construction
“A healthy athlete and other healthy individual and, as
applicable, another mammal individual who is not subject to
inpatient or outpatient care for relevant conditions by a hospital
or a medical or veterinary practitioner.”

Defendants’
Proposed Construction
Indefinite

The disputed term “healthy mammal” appears in claims 1 and 7 of the ‘364 patent.
(1) The Parties’ Positions
Plaintiff submits that its construction is supported by the specification. (See, e.g., Dkt.
No. 191 at 16.) Plaintiff argues that during prosecution the patent was distinguished from prior
art that related to treatment of critically ill patients as opposed to a healthy mammal including
man. (Id.)
Defendants respond that while portions of the specification appear to attempt to define
the term, the definitions are clearly inconsistent, and as a result, the patent fails to inform a
person of ordinary skill with reasonable certainty about the scope of the invention. (Dkt. No.
195 at 13.) Defendants argue that while portions of the specification teach that a “healthy
mammal” means one that is not being treated by a hospital or medical practitioner, the
subsequent inclusion by the specification of “other individuals” and “convalescents” (which may
be subject to in-patient or outpatient care) in the definition of “healthy mammal” creates
ambiguity. (Id. at 14.) Because the patent and specification provide no basis to distinguish the
status of individuals that are both included in and excluded from the classification of “healthy
mammal” in the context of the patent, the term is indefinite. (Id.)
Plaintiff replies that Defendants’ manufactured confusion regarding the term “healthy
mammal” is contradicted by the disclosures throughout the patent that define and provide context

19

to the term. (Dkt. No. 197 at 6.) Plaintiff argues that as demonstrated throughout the patent, a
healthy mammal in this case, including a human, is one that is able to engage in physical
exertion or strenuous physical exercise. (Id.) In particular, a healthy mammal is “a mammal
whose metabolism is capable of metabolizing energy in a regular way, and therefore one who
does not possess a medical condition that would preclude it from benefiting from the invention
and would not be presented a unreasonable risk from the use of the invention.” (Id.) Plaintiff
argues that the Defendants intentionally misinterpret the term “convalescent.” (Id. at 7.) The
term “convalescent” means a person who is recovering from an illness or operation, not someone
who is currently suffering from an illness, and even if the person is recovering, and subject to inpatient or outpatient care, Plaintiff argues that it does not mean that the person is “subject to
inpatient or outpatient care for relevant conditions” as stated in Plaintiff’s construction. (Id.)
(2) Analysis
The parties’ primary dispute is whether the specification provides a definition to the term
healthy mammal or whether there is so much ambiguity and/or inconsistency regarding this term
that it is rendered indefinite.
The parties have advanced no arguments on whether the prosecution history or the claims
are helpful to this dispute, and instead focus on the specification. The specification provides an
entire paragraph related to the meaning of a “healthy mammal” as envisioned by the ‘364 patent:
In the last decades, so called sports beverages have enjoyed an increased use by
athletes and others doing exercise. Such beverages have largely been based on
sugars, salt, minerals and proteins and fragments thereof. For example, in Dialog
Abstract No 02331774 (World Food & Drink Report, Oct. 19, 1989) a sports
drink named GatorPro is described including water, glucose, soy protein isolate
and soy oil. Various attempts have been made to provide a beverage, based on a
sound scientific concept, for athletes and other healthy individuals with a high
energy demand, e.g. certain convalescents. However, the demand for improved
beverages is still great. By a healthy individual in the context of this invention

20

is intended a human and, as applicable, another mammal individual who is
not subject to neither in-patient nor out-patient care for conditions relevant
herein by a hospital or a medical or veterinary practitioner. Thus the term
excludes patients requiring parenteral, or equivalent enteral, supply of the entire
or a very large proportion of the energy, electrolyte, fat or amino acid demand of
such patient. On the other hand, the term includes those athletes and
convalescents just mentioned and other individuals in a similar physical state,
although they may have deficiencies or surplus in their body tissues and liquids as
compared to an average non-diseased and fit individual.
(‘364 patent, col. 1, ll. 31 – 54) (emphasis added). Defendants appear to agree that the patentee
defined the term “healthy mammal,” but then argue that the later language in the specification
regarding this term renders the term indefinite. The Court disagrees.
The specification very clearly provides that by a “healthy individual in the context of this
invention” is “intended a human and, as applicable, another mammal individual who is not
subject to neither in-patient nor out-patient care for conditions relevant herein by a hospital or a
medical or veterinary practitioner.” (‘364 patent, col. 1, ll. 42-46.) The specification then
provides additional examples, stating that it excludes certain “patients requiring parenteral, or
equivalent enteral, supply of the entire or a very large proportion of the energy, electrolyte, fat or
amino acid demand of such patient,” and includes certain “athletes and convalescents just
mentioned and other individuals in a similar physical state.” (Id. at col. 1, ll. 47-52.) The
specification then states that for a healthy individual, “glutamine is classified as a non-essential
nutrient, that is, the body provides enough glutamine to satisfy the metabolic demand for said
amino acid. After physical trauma, whether accidental or intentional (e.g. surgery), some nonessential nutrients seem to become semi-essential in order to preserve physical functions such as
nitrogen balance and immune function.” (Id. at col. 2, ll. 5-11.) The specification then goes on
to state that for “the healthy individual, glucose and fatty acids are the predominant energy
substrates for the muscle.”

(Id. at col. 2, ll. 65-66.)

21

The physical tests described in the

specification were administered to “healthy men,” who on a regular basis practiced physical
exercise and to “athletes” who were “well trained long distance runners.” (See, e.g., id. at col. 6,
l. 65 – col. 8, l. 25.) The prosecution history provides additional guidance as to this term, and in
one instance, states that “[i]n the healthy individual, glucose and fatty acids are the predominant
energy substrates for the muscle.” (See Dkt. No. 191-4 (Request for Reconsideration dated
October 16, 1997) at 1.)
The Court finds that the term “healthy mammal” is defined in the ‘364 patent. “When a
patentee explicitly defines a claim term in the patent specification, the patentee’s definition
controls.” Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1380 (Fed. Cir. 2009)
(citing Phillips, 415 F.3d at 1321). In this instance, the patentee acted as a lexicographer and
defined “healthy individual” as the following:
By a healthy individual in the context of this invention is intended a human and,
as applicable, another mammal individual who is not subject to neither in-patient
nor out-patient care for conditions relevant herein by a hospital or a medical or
veterinary practitioner.
(‘364 patent, col. 1, ll. 42 – 46.) While the ‘364 patent provided additional examples of this term
and further discussions of a “healthy individual,” these additional discussions do not provide
inconsistency to the definition or change the fact that the patentee acted as a lexicographer and
that one of ordinary skill would understand the meaning of this term based on the specification.
The Court finds no reason to depart from the construction the patentee provided for this
term. At best, the Defendants argue that there is some inconsistency in the specification’s
treatment of the term healthy individual and that the use of the word “convalescents” makes the
term ambiguous. The Court disagrees. The definition of the term “convalescent” is “a person
who is recovering from an illness, an injury, or a surgical operation.” As argued by Plaintiff, the

22

fact that a person may be recovering from an illness or injury does not mean that the person is
subject to-inpatient or out-patient care for conditions relevant to the claimed invention. The
Court agrees with Plaintiff that the specification is clear that a healthy mammal is a mammal
whose body is capable of metabolizing energy in a regular way, and the conditions relevant to
the claimed invention (as stated in the patent’s definition of the term “healthy individual”) are
situations related to the metabolism of an individual.
The Court does not find that there are internal inconsistencies to render the claim
indefinite. The Court finds that there is no dispute that one of ordinary skill in the art would
understand the meaning of the term “healthy mammal” in the context of the claimed invention.
Likewise, the Court finds that there is no dispute that one of ordinary skill in the art would
understand with “reasonable certainty” the scope of the invention and the bounds of the claims.
Accordingly, pursuant to the Supreme Court’s holding in Nautilus, the Court rejects Defendants’
arguments that the claim when “read in light of the specification delineating the patent, and the
prosecution history, fail[s] to inform, with reasonable certainty, those skilled in the art about the
scope of the invention.”
The Court hereby construes “healthy mammal” to mean “an individual who is not
subject to inpatient or outpatient care for metabolic conditions by a hospital or a medical
or veterinary practitioner.”

23

D. “a beverage, or a dry composition thereof”
Plaintiff’s
Proposed Construction
“beverage, or a powder version of the
beverage that can be reconstituted with a
liquid”

Defendants’
Proposed Construction
For beverage: plain and ordinary meaning
For a dry composition therefor: “a dry
composition for making the claimed beverage”

The disputed term “a beverage, or a dry composition thereof” appears in claims 1, 2, and
7 of the ‘364 patent.
(1) The Parties’ Positions
Plaintiff submits that the specification of the ‘364 patent indicates that the claimed
invention can take the form of “either a beverage or a dry or powder version of the beverage.”
(See, e.g., Dkt. No. 191 at 4-5.) Plaintiff argues that because the specification teaches that if the
beverage is ready for consumption it comprises water, that either a dry or powder version can be
reconstituted with water. (Id. at 5.) Plaintiff further argues that Defendants’ construction is
ambiguous and does not fully describe the claimed invention as compared to Plaintiff’s more
precise construction. (Id.)
Defendants respond that the phrase “dry composition therefore” is repeated throughout
the specification, does not need a separate construction, and is simply referring back to the
previously cited beverage. (See, e.g., Dkt. No. 195 at 24.)

Defendants argue that there is no

reason to complicate the claim language by adding Plaintiff’s construction, and none of the terms
“powder,” “version,” or “reconstituted” appear in the ‘364 patent. (Id.) Further, there is nothing
in the ‘364 patent that suggests the “dry composition” has to be a “powder.” (Id.) Defendants
argue that Plaintiff provides no support that Defendants’ construction is improper. (Id.)

24

Plaintiff replies that Defendants’ construction is of no use to a jury and is self-defining
and provides no context. (See, e.g., Dkt. No. 197 at 9.)
(2) Analysis
The parties dispute whether “beverage” should be separately construed or be included in
the larger phrase of “a beverage, or a dry composition thereof.” Because neither party disputes
that “beverage” should be given its plain and ordinary meaning, no separate construction is
needed and the Court will consider “beverage” as part of the larger phrase of “a beverage, or a
dry composition thereof.”
The parties’ dispute largely rests on whether a dry composition is just that – a dry
composition – or whether it is a powder version. The claim language does not use the term
“powder.” Likewise, neither the specification nor any other intrinsic evidence uses the term
“powder.” In contrast, the term “dry composition” is used repeatedly in the specification. (See,
e.g., ‘364 patent, col. 3, ll. 49-50, ll. 59-60, ll. 66-67.) Further, the patent specifically mentions
that the water-soluble carrier “is in dry form if the beverage is provided as an extract for
dilution” and that “[i]f the beverage is provided ready for consumption it further comprises
water.” (Id. at col. 4, ll. 13-18.)
The Court is not convinced that the broadly used “dry composition” term should be
limited to a “powder version.” First, there is no intrinsic support for this “powder” term.
Second, it is unclear what the differences (if any) are between a “powder version” and “dry
composition.” Third, even if the terms had the same or similar meanings, there is no reason to
substitute the term “powder” for the disputed term as the Court is not convinced that simply
replacing easily understood terms with other terms is either helpful to the jury or appropriate.
Because construing the “dry composition” term will only tend to confuse rather than clarify, the

25

term requires no further construction. See U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554,
1568 (Fed. Cir. 1997) (“Claim construction is a matter of resolution of disputed meanings and
technical scope, to clarify and when necessary to explain what the patentee covered by the
claims, for use in the determination of infringement.

It is not an obligatory exercise in

redundancy.”); see also O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351,
1362 (Fed. Cir. 2008) (“[D]istrict courts are not (and should not be) required to construe every
limitation present in a patent’s asserted claims.”) (citing U.S. Surgical, 103 F.3d at 1568). The
Court finds that the term “dry composition” has no special meaning other than its plain and
ordinary meaning. The Court agrees with the Defendants that the term “thereof” is simply
referring back to the claimed beverage. Further, during the claim construction hearing Plaintiff
withdrew its request to limit the phrase “dry composition” to a “powder version of the beverage.”
The Court hereby construes “a beverage, or a dry composition thereof” to mean “a
beverage, or a dry composition for making the beverage.”

E. “comprising 0.1 to 2.5 percent of the wet weight of α-ketoglutaric acid”
Plaintiff’s
Proposed Construction
“includes 0.1 to 2.5 grams of alphaketoglutaric acid per 100 ml of liquid”

Defendants’
Proposed Construction
Plain and ordinary meaning

The disputed term “comprising 0.1 to 2.5 percent of the wet weight of α-ketoglutaric
acid” appears in claims 1 and 7 of the ‘364 patent.
(1) The Parties’ Positions
Plaintiff submits that the disputed phrase needs a precise definition for clarity. (See, e.g.,
Dkt. No. 191 at 8.) Plaintiff argues that its construction is supported by the specification’s use of

26

a certain amount of grams of alpha-ketoglutaric acid per 100 ml of liquid for various preferred
beverages. (Id.) The Plaintiff also argues that the prosecution history confirms its construction.
(Id. at 8-9.)
Defendants respond that the phrase is understandable and does not need construction.
(Dkt. No. 195 at 25.) Defendants argue that, read in context, the phrase is referring to the weight
of alpha-ketoglutaric acid as a percentage of the overall weight of the beverage.

(Id.)

Defendants argue that Plaintiff’s construction impermissibly changes the scope of the claim
term. (Id.) Plaintiff’s construction does not specify what the liquid is, and because different
liquids have different densities, using a fixed amount of alpha-ketoglutaric acid in one liquid
may provide a different wet weight percentage as opposed to another liquid. (Id.)

While the

specification provides an example of using 0.5 to 2.0 grams of alpha-ketoglutaric acid per 100
ml, the specification is silent as to how much of that 100 ml is water, whether other ingredients
are liquid, and what the wet range of the beverage is. (Id.) For example, Defendants argue that a
100ml beverage made according to Example 1 is actually 105.3 grams. (Id. at 26.) Defendants
also argue that the prosecution history cited by Plaintiff does not trump (and is not found in) the
claim language and specification and is a misreading of the relevant specification results. (Id.)
Plaintiff replies that its construction explains the calculation required to determine the
wet weight of the claimed invention. (Dkt. No. 197 at 9.) Plaintiff’s construction is consistent
with the examples of preferred beverages disclosed in the ‘364 patent and the tests disclosed in
the patent. (Id.)
(2) Analysis
There is no dispute between the parties that the claims clearly recite “comprising 0.1 to
2.5 percent of the wet weight of α-ketoglutaric acid.” The terms “wet” and “wet weight” are not

27

used in the specification of the ’364 patent. The dispute between the parties is whether the
phrase should mean what it clearly states (as proposed by Defendants) or whether it should be
limited to the embodiment provided in the specification (as proposed by Plaintiff).
In one part of the patent, two particularly preferred beverages are described: one beverage
has a preferred range of 0.5-2.0 g of alpha-ketoglutaric acid per 100 ml and another beverage has
a preferred range of 1.0-1.5 g of alpha-ketoglutaric acid per 100 ml. (See, e.g., col. 4, ll. 35-60.)
Two other examples in the ‘364 patent specifically provide 1.2 and 1.5 grams of alphaketoglutaric acid per 100 ml. (Id. at col. 6, ll. 5-30.) For Physical Test 2 a beverage was
provided with varying content of 0.01 and 3.5 grams of alpha-ketoglutaric acid per 100 ml. (Id.
at col. 7, ll. 44-47.) The ‘364 patent teaches that individuals reported enhanced performance
when consuming a beverage of between 0.1 and 2.5 g of alpha-ketoglutaric acid per 100 ml. (Id.
at col. 7, ll. 53-56.)
Plaintiff argues that the prosecution history supports its construction. In a Request for
Reconsideration dated October 16, 1997, the Applicant characterized its invention and argued
around various prior art references. (See Dkt. No. 191-4 (Request for Reconsideration).) The
Applicant made various citations to the prior art as not having a certain percentage by weight of
a particular component. (See id. at 4-5.) In one instance, the Applicant cited to the specification
of the pending application and argued “a beverage containing 0.1 g of α-ketoglutaric acid per
100 ml (0.1% by weight) was deemed effective.” (Id. at 5.) Thus, Plaintiff argues that the
Applicant equates the phrase “percent of wet weight” to grams per 100 ml.
On balance, the Court finds that the claim language controls and rejects Plaintiff’s
construction. While there is some support for Plaintiff’s construction in the intrinsic record,
neither the specification nor the prosecution history uses the term “wet” or “wet weight” and

28

there is nothing in the intrinsic record that necessitates Plaintiff’s construction. The Federal
Circuit has consistently held that “particular embodiments appearing in the written description
will not be used to limit claim language that has broader effect.” Innova/Pure Water, 381 F.3d at
1117. Further, the prosecution history cited by Plaintiff does not persuade the Court that the
plain meaning of the claim term should be changed. There is no dispute that the disputed term is
easily understandable or that one of ordinary skill would understand what the term means. Had
the Applicant intended to mean a certain amount of grams per 100 ml of liquid – as Plaintiff
argues – it could have easily claimed such a limitation. In contrast, it specifically used the
“comprising 0.1 to 2.5 percent of the wet weight of α-ketoglutaric acid” language. Absent clear
evidence to the contrary, the Court is hesitant to change the plain meaning of a term. Because a
plain and ordinary meaning construction resolves the dispute between the parties as to this term,
no further construction is necessary. See U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554,
1568 (Fed. Cir. 1997) (“Claim construction is a matter of resolution of disputed meanings and
technical scope, to clarify and when necessary to explain what the patentee covered by the
claims, for use in the determination of infringement.

It is not an obligatory exercise in

redundancy.”); see also O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351,
1362 (Fed. Cir. 2008) (“[D]istrict courts are not (and should not be) required to construe every
limitation present in a patent’s asserted claims.”) (citing U.S. Surgical, 103 F.3d at 1568).
The Court hereby construes “comprising 0.1 to 2.5 percent of the wet weight of αketoglutaric acid” to have its plain meaning.

29

F. “water-soluble innocuous salt thereof”
Plaintiff’s
Proposed Construction
“a water-soluble salt of alpha-ketoglutaric acid
that is harmless and does not have an
objectionable taste or other negative
characteristic or does not otherwise interfere
with the intended use of the beverage”

Defendants’
Proposed Construction
“A salt that would not harm the subject and
where the non-α-ketoglutaric acid portion of
the salt is not a physiologically active
compound”

The disputed term “water-soluble innocuous salt thereof” appears in claims 1 and 7 of the
‘364 patent.
(1) The Parties’ Positions
Plaintiff submits that the specification and prosecution history support its proposed
construction. (See, e.g., Dkt. No. 191 at 9-10.) In particular, the Plaintiff argues that the
USPTO, in its rejection of the inter partes petition of the ‘364 patent, found that the term
“innocuous salt thereof” encompasses innocuous salts of alpha-ketoglutarate. (Id.) Plaintiff also
relies on various prior art references and dictionary definitions. (Id. at 10.) Plaintiff argues that
innocuous does not mean inactive and there is no reason to believe that the non-alphaketoglutaric acid portion of the salt is not a physiologically active compound. (Id.)
Defendants respond that Plaintiff’s construction captures products with complex,
physiologically active amino acids in combination with α-ketoglutarate by calling such
combinations “innocuous salts.” (See, e.g., Dkt. No. 195 at 15.) Defendants’ construction seeks
to exclude those complex compounds from being “innocuous salts.” (Id.) Defendants argue that
their construction is based in the prosecution history, the claim language, the specification, the
relevant science of metabolism, the USPTO’s claim construction during the inter partes review
decision, and common sense. (Id. at 16-23.)

30

Plaintiff replies that Defendants’ construction is unsupported by the patent specification,
the prosecution history, and the meaning of the term “complex” in terms of the prior art. (See,
e.g., Dkt. No. 197 at 7-9.) Plaintiff argues that there is no reason that an innocuous salt
component must be limited to a simple inert or inactive component. (Id. at 7.)
(2) Analysis
The intrinsic record is clear that claims 1 and 7 include water-soluble innocuous salts that
can be substituted for the alpha-ketoglutaric acid. The parties’ primary dispute as to this term is
whether innocuous means inactive (as argued by Defendants) or whether it means harmless and
without any negative consequences (as argued by Plaintiff). In particular, the parties dispute
whether the salt can include complex, physiologically active amino acids in combination with
alpha-ketoglutarate. The Defendants provide multiple arguments as to why the equivalent salt
must be inactive. Defendant’s substantive arguments are addressed below.
The claim language and specification are not that helpful as to this dispute. Nothing in
the specification or claim language provides any specific guidance as to what is meant by a salt
or by the term “innocuous.” Nonetheless, there seems to be no dispute that alpha-ketoglutarate is
simply the anion form of alpha-ketoglutaric acid, that alpha-ketoglutarate is formed by removing
the hydrogen atoms from α-ketoglutaric acid, and that a salt of alpha-ketoglutaric acid is then
formed by replacing the removed hydrogen atoms with another substance. However, the ‘364
patent disclosure provides no guidance as to whether the innocuous salt may include an active
portion separate from the alpha-ketoglutaric acid component.

Defendants argue that the

Applicant would not have included complex, physiologically active amino acids in combination
with α-ketoglutarate within the claims’ scope without disclosing them or doing testing on them.
(See, e.g., Dkt. No. 195 at 17.) Defendants argue that if the claims at issue extend to cover

31

physiologically active amino acids in combination with α-ketoglutarate, the patent may well be
invalid to due lack of enablement/utility. (Id.) The Court does not find Defendants’ arguments
persuasive here. The mere fact that the specification does not teach all salt variations does not
necessarily preclude a broad claim from covering multiple salt embodiments. Further, the Court
finds that these are largely written description or enablement arguments and not necessarily
claim construction arguments. Whether or not the specification sufficiently enables or describes
a particular claim term is a validity argument – not a claim construction argument – and the
Court will not address these separate issues at this time.
Defendants also argue that the relevant science contradicts Plaintiff’s construction. (See,
e.g., Dkt. No. 195 at 18.) Defendants argue that complex, physiologically active amino acids in
combination with α-ketoglutarate behave differently in the human body than do simple mineral
salts of α-ketoglutaric acid or α-ketoglutaric acid alone. (Id.) Because ornithine, arginine, and
glutamine alpha-ketoglutarate would have different effects on the human body from alphaketoglutaric acid alone, Defendants argue that it is unlikely that one skilled in the art would
consider such physiologically active amino acids in combination with alpha-ketoglutarate
“innocuous.” (Id. at 19.) Instead, a salt of alpha-ketoglutaric acid is formed by replacing
removed hydrogen atoms from the acid with another substance, such as sodium (relied upon by
the PTAB). (Id. at 20.) The Court finds that these arguments are not determinative as to the
meaning of “innocuous.” Whether a complex, physiologically active amino acid in combination
with α-ketoglutarate acts differently than a mineral salt of alpha-ketoglutaric acid does not
necessarily preclude such a compound from being considered as an “innocuous” salt.
Defendants also provide a “common sense” argument, in that if Plaintiff’s construction
were correct, then almost any combination with or salt of alpha-ketoglutaric acid would be

32

included within the scope of the asserted claims and would effectively read the term “innocuous”
out of the claims. (Id. at 21.) The Court finds that these arguments are not determinative as to
the meaning of “innocuous.” A common meaning for the term “innocuous” is harmless. The
fact that a wide variety of salts could be considered “harmless” does not render this limitation
superfluous.
Defendants rely mostly on the prosecution history in support of their arguments. First,
Defendants argue that the Applicant disclaimed physiologically active amino acids in
combination with alpha-ketoglutarate during the original prosecution of the ‘364 patent in the
context of treating trauma or surgery patients. (See, e.g., Dkt. No. 195 at 16.) As to this
argument, the Court does not find any evidence of disclaimer – particularly any “clear” and
“unambiguous” disclaimer – that the salts must be inactive salts and not physiologically active
amino acids. Second, Defendants argue that the PTAB opinion supports their construction. (See,
e.g., Dkt. No. 195 at 20-21.) In front of the PTAB were various prior art references that included
both complex and inactive salts. These include a monosodium salt of alpha-ketoglutarate (the
Kihlberg reference) and a complex salt of alpha-ketoglutarate pyridoxine (the Marconi reference
and the Glutarase Catalog reference), which is an alpha-ketoglutarate with vitamin B6
(pyridoxine). (See, e.g., Exh. 191-5 at 921-989.) For the Marconi reference, which was directed
to a complex of alpha-ketoglutarate with pyridoxine, the Applicant repeatedly stated that the
Marconi reference did not teach that alpha-ketoglutaric acid could be used alone and only that
when it was combined with the pyridoxine it was useful for enhancing energy. (See, e.g., Patent
Owner’s Preliminary Response to Petition, dated August 23, 2013, Dkt. No. 191-5 at 979.) The
Applicant described pyridoxine as a physiologically active molecule also known as vitamin B6.
(Id. at 981). The Applicant further distinguished the Marconi reference as being directed not to

33

“particular amounts of AKG [alpha-ketoglutaric acid]” but to the “administration of a complex
between AKG and another physiologically active substance, pyridoxine” and that it taught that
AKG alone was not useful in situations that require a rapid energy supply. (Id. at 982-83.) The
PTAB Opinion agreed with the Applicant and stated that the Marconi reference did not teach that
alpha-ketoglutarate had the same effect as the alpha-ketoglutarate pyridoxine complex, which
“has properties that are distinct from its individual components.” (PTAB Opinion at 8, Dkt. No.
191-5 at 997.) Further, the PTAB Opinion stated “an ordinary artisan would understand that a
water-soluble innocuous salt of alpha-ketoglutaric acid is alpha-ketoglutarate, wherein the
hydrogen atoms of the alpha-ketoglutaric acid are substituted with an anion [sic], such as a
sodium anion.” (Id. at 995.)
Based on the prosecution history as a whole, the Court finds that Plaintiff distinguished
the Marconi reference from its claimed invention and the PTAB relied on this distinction. The
Court finds that the primary reason that the Applicant obtained its claims was that the prior art
did not teach that alpha-ketoglutaric acid (or an innocuous salt thereof) by itself provided the
desired energy supply. The Court must give affect to the prosecution history. See Phillips, 415
F.3d at 1317. Accordingly, consistent with the express language used by the Applicant during
the inter partes petition, the Court finds that the claimed invention cannot apply to the type of
structure disclosed in Marconi – the “administration of a complex between AKG and another
physiologically active substance.”
Both parties agree that “innocuous” means “harmless.” The Court rejects Plaintiff’s
proposal that the term also means that it “does not have an objectionable taste or other negative
characteristic or does not otherwise interfere with the intended use of the beverage.” Such a

34

construction has no support in the specification and the Court is not convinced that it is
necessary.
The Court hereby construes “water-soluble innocuous salt thereof” to mean “a
harmless, water-soluble salt of alpha-ketoglutaric acid that is not a complex between alphaketoglutaric acid and another physiologically active substance.”

G. “wherein α-ketoglutaric acid is combined with malic acid”
Term

Plaintiff’s
Proposed Construction
“wherein αThis should be construed in
ketoglutaric acid context. The term “alphais combined with ketoglutaric acid” means alphamalic acid”
ketoglutaric acid or its watersoluble innocuous salt. The term
(claim 2)
“malic acid” means malic acid or
its equivalent salt when in dry form.
“malic acid”
“malic acid or its equivalent salt
when in dry form”
(claim 2)
“α-ketoglutaric
This term should be construed in
acid”
context, and means alphaketoglutaric acid or its water(claim 2)
soluble innocuous salt.

Defendants’
Proposed Construction
Limited to formulations using αketoglutaric acid only, and excluding
formulations using a salt of the acid
or the α-ketoglutarate anion combined
with formulations using malic acid
only, and excluding any salt of malic
acid.
Limited to formulations using malic
acid only, and excluding formulations
using any salt of malic acid.
Limited to formulations using αketoglutaric acid only, and excluding
formulations using a salt of the acid
or the α-ketoglutarate anion.

The disputed term “wherein α-ketoglutaric acid is combined with malic acid” appears in
claim 2 of the ‘364 patent. The parties also dispute separately the constituent terms of “αketoglutaric acid” and “malic acid.”
(1) The Parties’ Positions
Plaintiff submits that, in the context of the patent, the term “alpha-ketoglutaric acid”
means “alpha-ketoglutaric acid or its water-soluble innocuous salt” and the term “malic acid”
means “malic acid or its equivalent salt when in dry form.” (See, e.g., Dkt. No. 191 at 11, 17, 18,

35

21.) Plaintiff argues that because claim 2 recites a “beverage, or a dry composition therefor,”
that claim 2 necessarily encompasses a dry form of the claimed invention and thus the recited
alpha-ketoglutaric acid and malic acid would include the equivalent salts. (Id. at 11, 17.)
Plaintiff argues that one of ordinary skill in the art would understand that the ‘364 patent teaches
the use of equivalent salts and that salts are readily interchangeable with the acids.

(Id.)

Plaintiff argues that Defendants’ construction imposes a limitation not supported by the patent
specification or the understanding of a person having ordinary skill in the art. (Id. at 21.)
Defendants respond that claim 2 cannot be construed to include salts of each acid because
such a construction substantially alters what the ‘364 patent claims and would render limitations
from both independent claims superfluous and redundant. (See, e.g., Dkt. No. 195 at 27.)
Defendants argue that the specification and claims repeatedly distinguishes between acids and
salt. (Id.) Defendants also argue that the Federal Circuit opinion in Pfizer v. Ranbaxy Labs.
supports their construction and that the PTAB Opinion also supports their construction. (Id. at
28-29.)
Plaintiff replies that Defendants’ constructions are not supported by the patent. (See, e.g.,
Dkt. No. 197 at 9-10.) Plaintiff argues that limiting the construction of the claim to malic acid
alone and not the salt of malic acid is to ignore the language of the claim itself. (Id. at 10.)
Plaintiff argues that because claim 2 claims a “beverage, or a dry composition therefor,” the dry
form of the invention in claim 2 would necessarily include the equivalent salts of malic acid and
alpha-ketoglutaric acid. (Id.)
(2) Analysis
The parties’ primary dispute is whether the acids recited in claim 2 should be interpreted
to include their innocuous salts despite the claim not expressly including any salts. While the

36

parties dispute and brief each of the “malic acid” and “alpha-ketoglutaric acid” terms separately,
the Court considers these terms in the larger phrase of “wherein α-ketoglutaric acid is combined
with malic acid” and no separate constructions for the constituent terms are necessary.
Claim 1 of the ‘364 patent expressly states the use of “alpha-ketoglutaric acid” or its
“water soluble innocuous salt”:
1. A beverage, or a dry composition therefor, providing an energy source in
situations with demand of large and rapid energy supply to a healthy mammal
comprising 0.1 to 2.5 percent of the wet weight of α-ketoglutaric acid or a
water-soluble innocuous salt thereof together with a nutritionally acceptable
water-soluble carrier.
(Emphasis added.)

Thus, by its simple claim language, claim 1 treats and claims “alpha-

ketoglutaric acid” different than its “water soluble innocuous salt.” In contrast, claim 2 expressly
recites only acid components and not salts:
2. A beverage, or a dry composition therefor, according to claim 1, wherein αketoglutaric acid is combined with malic acid.
(Emphasis added.)
Plaintiff relies on primarily two arguments for its proposed construction. First, because
claim 2 recites a “beverage, or a dry composition therefor,” the mere recitation of the acids
would also by necessity include the equivalent salts. Second, one of ordinary skill in the art
would understand the patent to teach the use of equivalent salts for malic acid and alphaketoglutaric acid and thus the claims should not exclude such salts. The Court does not find
either argument persuasive. First, the mere reference back to the preamble of claim 1 does not
trump the clear recitation of only “malic acid” and “alpha-ketoglutaric acid.” Second, the fact –
even if true – that one of ordinary skill in the art would understand that equivalent salts could be
substituted for acids to obtain the benefits recited in the invention does not trump or account for

37

the lack of the term “salt” in the claim language. Further, there is no disclosure in the ‘364
patent of using equivalent salts in place of malic acid.
The Court finds that, based on the express claim language, the mere recitation of “alphaketoglutaric acid” and “malic acid” does not include any equivalent salts. It is clear that the
Applicant knew how to claim an innocuous salt of an acid when desired (as the Applicant did in
claim 1). The fact that the Applicant did not do so in claim 2 and did so in claim 1 provides
strong support that the mere recitation of acids in claim 2 does not also include their innocuous
salts. See also Pfizer, Inc. v Ranbaxy Laboratories Ltd., 457 F.3d 1284, 1291-92, n. 6 (Fed. Cir.
2006) (when a dependent claim only recited an acid and did not include the language
“pharmaceutically acceptable salts thereof” found in the independent claim, the dependent claim
did not include any corresponding salts). If one of ordinary skill in the art would understand that
the recitation of acids necessarily includes their equivalent salts (as proposed by Plaintiff), then
there would be no need for the recitation of such “innocuous salts” in claim 1. Further, there is
no reference or teaching in the ‘364 patent that innocuous salts of malic acid can be used. Still
further, this construction is consistent with the PTAB Opinion, in which the PTAB declined to
find that the simple recitation of “alpha-ketoglutaric acid” would necessarily include the alphaketoglutaric acid and its anion, the alpha-ketoglutarate salt. (PTAB Opinion at 6.)
Absent clear evidence to the contrary, the Court is hesitant to change the plain meaning
of a term. Because a plain and ordinary meaning construction – one that is limited to the recited
acids and not the inclusion of their salts – resolves the dispute between the parties as to this term,
no further construction is necessary. See U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554,
1568 (Fed. Cir. 1997) (“Claim construction is a matter of resolution of disputed meanings and
technical scope, to clarify and when necessary to explain what the patentee covered by the

38

claims, for use in the determination of infringement.

It is not an obligatory exercise in

redundancy.”); see also O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351,
1362 (Fed. Cir. 2008) (“[D]istrict courts are not (and should not be) required to construe every
limitation present in a patent’s asserted claims.”) (citing U.S. Surgical, 103 F.3d at 1568).
The Court hereby construes “wherein α-ketoglutaric acid is combined with malic
acid” to have its plain meaning.

Separate constructions of the constituent terms are not

necessary.
.
IV. CONCLUSION
The Court adopts the above constructions set forth in this opinion for the disputed terms
of the patent-in-suit. The parties are ordered that they may not refer, directly or indirectly, to
each other’s claim construction positions in the presence of the jury. Likewise, the parties are
ordered to refrain from mentioning any portion of this opinion, other than the actual definitions
adopted by the Court, in the presence of the jury.

Any reference to claim construction

proceedings is limited to informing the jury of the definitions adopted by the Court.
SIGNED this 3rd day of January, 2012.
SIGNED this 3rd day of November, 2014.

____________________________________
ROY S. PAYNE
UNITED STATES MAGISTRATE JUDGE

39