Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_06-cv-02754/USCOURTS-cand-3_06-cv-02754-11/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 35:271 Patent Infringement

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United States District Court

For the Northern District of California

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28 1 Plaintiffs’ claims against Iovate Health Sciences USA, Inc., Jarrow Industries, Inc.,

Jarrow Formulas, Inc. and Siva Hari have either been settled or are in the process of settling. Ronald

Udell has been dismissed from this case. The remaining Defendants are Kenko USA, Inc., Soft-Gel

Technologies and Chemco Industries, Inc. 

United States District Court

For the Northern District of California

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

USE TECHNO CORPORTATION AND

FUTOSHI MATSUYAMA,

Plaintiffs,

 v.

KENKO USA, Inc., et.al.,

Defendants. /

No. C-06-02754 EDL

ORDER RE: CLAIM CONSTRUCTION

OF UNITED STATES PATENT 6,716,459

Before the Court is the parties’ dispute over the proper construction of certain terms in

United States Patents No. 6,716,459 (“the ’459 patent”). 

I. BACKGROUND

Plaintiffs Use Techno Corporation and Futoshi Matsuyama (collectively, “Plaintiffs”) have

filed suit against Defendants Iovate Health Sciences USA, Inc., Jarrow Formulas, Inc., Jarrow

Industries, Inc., Kenko USA, Inc., Soft-Gel Technologies, Inc.,Chemco Industries, Inc., Ronald

Udell and Siva Hari1

 (collectively, “Defendants”) for patent infringement. According to the

complaint, Plaintiffs’ business is related to “studying natural active chemical compounds and

developing, patenting and licensing the application developed.” Am. Compl. ¶ 1. Plaintiffs have

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identified corosolic acid as a specific extract of the Banaba plant (Lagerstroemia speciosa (Lin. or

Pers.)) leaves that has been found to maintain healthy blood sugar levels in humans. Id. Plaintiffs

are “engaged in the business of planting, harvesting, extracting, marketing, and selling corosolic

acid extracts for the prevention and treatment of diabetes, obesity, constipation and skin diseases.” 

Id. Plaintiff alleges that it owns the ‘459 patent and that Defendants are infringing the ‘459 patent

by importing, making, using, offering for sale and selling products containing corosolic acid. Am.

Compl. ¶ 61. 

The Court held a claim construction hearing for the ‘459 patent on June 27, 2007. 

II. LEGAL STANDARD

The construction of a patent claim is a matter of law for the Court. Markman v. Westview

Instruments, Inc., 517 U.S. 370, 372 (1996). A “bedrock principle” of patent law is that “‘the claims

of a patent define the invention to which the patentee is entitled to the right to exclude.’” Phillips v.

AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (quoting Innova/Pure Water,Inc. v. Safari Water

Filtration Systems, Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). The terms of a claim are generally

given their ordinary and customary meaning, that is, “the meaning that the term would have to a

person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective date

of the filing of the patent,” which provides an “objective baseline from which to begin claim

interpretation.” Phillips, 415 F.3d at 1313 (citing Innova, 381 F.3d at 1116). A court should look at

“‘those sources available to the public that show what a person of skill in the art would have

understood disputed claim language to mean.’” Id. at 1314 (quoting Innova, 381 F.3d at 1116). 

Those sources include “the words of the claims themselves, the remainder of the specification, the

prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of

technical terms and the state of the art.” Id. (quoting Innova, 381 F.3d at 1116); see also CCS

Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). 

A court should first focus on intrinsic evidence in construing patent claims. Importantly, the

context of the claim language is highly instructive. Phillips, 415 F.3d at 1314; see also Vitronics

Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“Although words in a claim are

generally given their ordinary and customary meaning, a patentee may choose to be his own

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lexicographer and use terms in a manner other than their ordinary meaning, as long as the special

definition of the term is clearly stated in the patent specification or file history.”) (citation omitted);

Hoechst Celanese Corp. v. BP Chems. Ltd., 78 F.3d 1575, 1578 (Fed. Cir. 1996) (“A technical term

used in a patent document is interpreted as having the meaning that it would be given by persons

experienced in the field of the invention, unless it is apparent from the patent and the prosecution

history that the inventor used the term with a different meaning.”). In addition, other claims of the

patent, whether asserted or not, can also illuminate the meaning of a claim term. Phillips, 415 F.3d

at 1314 (citing Vitronics, 90 F.3d at 1582). Claims, however, should be read in light of the

specification. Id. at 1315; Markman v.Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir.

1995) (en banc), aff’d, 517 U.S. 370 (1996)). The specification “‘is always highly relevant to the

claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a

disputed term.’” Phillips, 415 F.3d at 1315 (quoting Vitronics, 90 F.3d at 1582). In addition to the

specification, a court should also consider the patent prosecution history. Phillips, 415 F.3d at 1317;

see also Markman, 52 F.3d at 980 (“Although the prosecution history can and should be used to

understand the language used in the claims, it too cannot enlarge, diminish, or vary the limitations in

the claims.”) (internal quotation marks deleted) (citations omitted). However, the prosecution

history, which provides insight into how the Patent and Trademark Office and the inventor

understood the patent, “lacks the clarity of the specification and thus is less useful for claim

construction purposes.” Phillips, 415 F.3d at 1317. 

Ordinarily, the Court should not rely on extrinsic evidence to assist in claim construction,

because the public is entitled to rely on the public record of the patentee’s claim (as contained in the

patent claim, the specification, and the prosecution history) to ascertain the scope of the claimed

invention. Vitronics, 90 F.3d at 1583. Extrinsic evidence, such as expert testimony, dictionaries and

treatises, should be used only if needed to assist in determining the meaning or scope of technical

terms in the claims, or to understand the underlying technology, and may not be used to vary or

contradict the terms of the claims. Id. (citing Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211,

1216 (Fed. Cir. 1995)); Phillips, 415 F.3d at 1318-19; Markman, 52 F.3d at 981. External evidence

is “‘less significant than the intrinsic record in determining the legally operative meaning of claim

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language.’” Phillips, 415 F.3d at 1317 (quoting C.R. Bard, Inc.v. U.S. Surgical Corp., 388 F.3d 858,

862 (Fed. Cir. 2004) (internal quotations omitted)). “Extrinsic evidence may be useful to the court,

but it is unlikely to result in a reliable interpretation of patent claim scope unless considered in the

context of intrinsic evidence.” Id. at 1319. 

An accused infringer may overcome the heavy presumption that a claim term carries its

ordinary and customary meaning, but “he cannot do so simply by pointing to the preferred

embodiment or other structures or steps disclosed in the specification or prosecution history.” CCS

Fitness, 288 F.3d at 1366; see also Phillips, 415 F.3d at 1323 (“. . . we have repeatedly warned

against confining the claims to those embodiments [contained in the specification].”). Neither the

specification nor the title of the patent can be used to import limitations into the claims that are not

found in the claims themselves. Pitney-Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1312

(Fed. Cir. 1999). While the claims must be read in view of the specification, limitations from the

specification are not to be read into the claims. Phillips, 415 F.3d at 1323. 

III. DISCUSSION 

The ‘459 patent is entitled “Composition for Inhibiting Increase of Blood Sugar Level or

Lowering Blood Sugar Level.” This patent has two claims:

1. A composition for inhibiting an increase in, or lowering, a blood

sugar level, in a human patient in need thereof, consisting

essentially of:

a concentrate of ethanol or ethanol aqueous solution extract of

leaves of Lagerstroemia Speciosa, Linn. or Pers. having a

corosolic acid content of 0.01 to 15 mg per 100 mg of the

concentrate.

2. The composition according to claim 1, wherein said ethanol

solution contains 50 to 80 by weight of ethanol. 

‘459 patent at col. 6, lines 57-65. The parties ask the Court to construe the following

eleven terms from the claims of the ‘459 patent.

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Disputed claim language Plaintiffs’ construction Defendants’ construction

A composition for

inhibiting an increase in, or

lowering, a blood sugar

level

The preamble of this

patent is clear and

unambiguous and therefore

is not in need of

construction. 

A mixture made up of one

or more ingredients that

has the effect of preventing

blood glucose from rising

above a normal level, or

lowering blood glucose to

a normal level.

Language in a claim’s preamble is appropriate for construction when it limits the

claimed invention. A preamble generally limits the claimed invention if it “recites

essential structure or steps, or if it is necessary to give life, meaning and vitality to the

claim.” NTP, Inc. v. Research in Motion, 418 F.3d 1282, 1305 (Fed. Cir. 2005) (quoting

Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)

(“Additionally, dependence on a particular disputed preamble phrase for antecedent basis

may limit claim scope because it indicates a reliance on both the preamble and claim

body to define the claimed invention. [citation omitted] Likewise, when the preamble is

essential to understand limitations or terms in the claim body, the preamble limits claim

scope. [citation omitted] Further, when reciting additional structure or steps underscored

as important by the specification, the preamble may operate as a claim limitation.

[citation omitted]”). However, preamble language is generally not limiting “‘where a

patentee defines a structurally complete invention in the claim body and uses the

preamble only to state a purpose or intended use for the invention.’” Catalina Mktg, 289

F.3d at 808 (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). Here, the

parties agreed at the hearing that the preamble language is limiting. They disagree,

however, on whether the language needs to be construed. 

The disagreement focuses on Defendants’ proposed substitution of the word

“preventing” for “inhibiting.” Plaintiffs argue that the use of “preventing” is too limiting,

and that the word “inhibiting,” as used in the claim language, is clear and not in need of

construction. The Court agrees that “preventing” is different from, and more restrictive

than, the term “inhibiting.” Defendants have made no showing, based on any intrinsic or

extrinsic evidence, that “inhibiting” should be given a construction that is more

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restrictive than its ordinary meaning. For example, the specification does not contain the

term “preventing,” nor does the context of the claim language warrant use of this term. 

The specification includes language regarding keeping blood sugar at a normal level, but

because the Court may not read limitations from the specification into the claims, the use

of “preventing” would improperly impose limitations on the claim that are not found in

the claims themselves. Finally, no party presented any prosecution history as to the

meaning of “inhibiting” that would justify giving it a limited meaning. 

In this context, inhibiting means slowing down or impeding, in whole or in part, a

person’s blood sugar level from increasing or going up higher than it otherwise would but

for the method employed. See Pl.’s Reply at 2:14-16. This definition, however, only

reiterates the plain meaning of “inhibiting,” and therefore does not clarify or aid in

understanding a disputed term. See United States Surgical Corp. v. Ethicon, Inc., 103

F.3d 1554, 1568 (Fed. Cir. 1997) (“Claims construction is a matter of resolution of

disputed meanings and technical scope, to clarify and when necessary to explain what a

patentee covered by the claims, for use in the determination of infringement. It is not an

obligatory exercise in redundancy.”). Accordingly, the Court declines to construe this

language.

Disputed claim language Plaintiffs’ construction Defendants’ construction

in a human patient in need

thereof

The preamble is clear on

its face, and therefore the

court should decline to

construe it. 

in a human diabetic patient

who has an above-normal

blood glucose level, or is

expected to suffer an

increase in blood glucose

level above a normal level.

A “patient” is one who is

suffering from any disease

or behavioral disorder and

is under treatment for it.

 

This disputed claim language also appears in the preamble. The parties agree that

this phrase is limiting, but disagree that it needs to be construed. At the hearing,

Defendants submitted documents from the prosecution history of United States Patent

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No. 6,485,760 and of the ‘459 divisional patent to demonstrate that Plaintiffs

differentiated prior art by emphasizing that these patents envisioned use of the corosolic

acid in human beings. See Declaration of Sri Sankaran Regarding Exhibits Used at

Claim Construction Hearing (“Sankaran Decl.”) Ex. A at 7-8 (“It is respectfully

submitted that it is and would be totally improper to conclude that one skilled in the art

would learn or believe from Murakami that corosolic acid would be effective in treating

blood sugar imbalances in human patients much less what a suitable dosage should be for

this utility. That is, the disclosure of Murakami is limited to the results of in vitro tests

using tumor cells and rats. . . . one skilled in the art would not try to and could not

predict whether the concentrate would be effective to inhibit an increase in or reduction

in human blood sugar level when an undisclosed dosage amount of concentrate is orally

administered to a human being.”) (emphasis in original); Ex. B at 2 (“Applicants note

that claims drawn to methods of treating a human diabetic patient have been allowed in

the priority application. The presently filed divisional application is directed to the

patentable compositions used in the allowed methods.”). Defendants argue that a human

patient as referenced in the patent is a diabetic patient, one whose blood sugar level is

elevated or is expected to be elevated. Plaintiffs object to this proposed construction

because it is too restrictive; they argue that a “patient” could be someone who desires to

inhibit from rising or to lower a blood sugar level without having a diabetes diagnosis or

being at risk for diabetes, for example, to slow down weight gain. Plaintiffs point to the

prosecution history of the ‘760 patent submitted by Defendants, which at one point

references a human being, not a human patient. See Sankaran Decl. Ex. A at 8. 

The Court is not convinced that this phrase needs construction. Defendants point

to no intrinsic or extrinsic evidence to support limiting the term “patient” to the definition

proposed by Defendants. The patentee could have specified in the claims that the human

patient be diabetic, but chose not to and instead made the claim more broad. The

specification contains numerous references to treatment of diabetes using corosolic acid. 

See, e.g. ‘459 patent at col. 1, lines 32, 45, 61; col. 2, lines 16. However, importing

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Defendants’ restrictive proposed construction would improperly read limitations from the

specification into the claim. Moreover, a person may be a “patient” without necessarily

having a particular confirmed diagnosis or being under current treatment. Defendants’

proposed construction would simply invite more questions about what constitutes “under

treatment” in terms of frequency of contact with and type of treatment provider. 

Indeed, Defendants’ proposed construction of “patient” is subsumed within the

plain language of the last portion of this claim phrase, “in need thereof.” If a patient has

or is expected to have an above-normal blood glucose level, then that patient would be

“in need thereof” of the patent invention, which purports to inhibit an increase in or lower

blood sugar levels. This is evident from the context of the claims themselves and from

the specification. If a person has normal blood sugar level and no reason to try to prevent

an increase in blood sugar, then he or she is not “in need thereof” under the patent, and

would therefore not fall within the claim language. 

Finally, this phrase is not beyond the understanding of a typical juror. The Court

finds no reason to import a more restrictive construction of the phrase “in a human

patient in need thereof” than its ordinary meaning. Accordingly, the Court declines to

construe this phrase. 

Disputed claim language Plaintiffs’ construction Defendants’ construction

blood sugar level The concentration of

glucose in blood

Agreed

The parties agree on the construction of this term. Therefore, the Court adopts the

agreed construction of “blood sugar level.” 

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Disputed claim language Plaintiffs’ construction Defendants’ construction

consisting essentially of The invention necessarily

includes the listed

components and is open to

unlisted ingredients that do

not materially affect the

basic and novel properties

of the claim. 

The transitional phrase,

“consisting essentially of,”

signals that the invention

necessarily includes the

listed ingredients and is

open to unlisted

ingredients that do not

materially affect the basic

and novel properties of the

claim. Thus, as used in

this claim, the transitional

phrase should be read so as

to exclude any ingredients

that affect the ability of the

claimed composition to

prevent blood glucose

level from rising above a

normal level, or to lower

blood glucose level to a

normal level.

There is essentially no dispute as to the meaning of this phrase. The phrase

“consisting essentially of” is a middle ground transitional phrase used to signal a partially

open claim in a patent. PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1354 (Fed.

Cir. 1998) (A “consisting essentially of” claim occupies a middle ground between closed

claims that are written in a “consisting of” format and fully open claims that are drafted

in a “comprising” format.”). At the hearing, the parties agreed that the first sentence of

Defendants’ proposed construction and Plaintiffs’ proposed construction were essentially

the same and constituted an accurate statement of the law. The second sentence of

Defendants’ proposed construction unduly restricts this transitional phrase and

incorporates the flaws in its proposed construction of the first disputed term. Therefore,

the Court adopts the following construction of “consisting essentially of:” “the invention

necessarily includes the listed components and is open to unlisted ingredients that do not

materially affect the basic and novel properties of the claim.”

//

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Disputed claim language Plaintiffs’ construction Defendants’ construction

concentrate A compound extracted

from the leaves of the

Banaba plant

(Lagerstroemia speciosa, Linn. or Pers.).

A substance which is

extracted from the leaves

of the Lagerstroemia

Speciosa, Linn. or Pers.,

and which is concentrated.

There is essentially no dispute about the meaning of this term. At the hearing,

Plaintiffs agreed that the words, “which is concentrated,” should be included in the

construction. In addition, for ease of reference, the parties agreed that the words “Banaba

plant” should be used in addition to the plant’s Latin name, “Lagerstroemia speciosa,

Linn. or Pers.” Further, there is no meaningful difference between “compound” and

“substance,” and at the hearing, the parties agreed to the use of the word “substance.” 

Accordingly, the Court adopts Defendants’ construction of this term as modified: “A

substance which is extracted from the leaves of the Banaba plant (Lagerstroemia

speciosa, Linn. or Pers.) and which is concentrated.”

Disputed claim language Plaintiffs’ construction Defendants’ construction

a concentrate of ethanol or

ethanol aqueous solution

extract of leaves of

Lagerstroemia speciosa, Linn. or Pers.

No construction necessary

because the proper

approach is to define the

terms of the phrase

A substance which is

extracted from the leaves

of Lagerstroemia speciosa, Linn. or Pers., using

ethanol or a solution of

ethanol and water, and

which is concentrated.

There is essentially no dispute about the meaning of this phrase. Because several

terms in this phrase will be construed, construction of this phrase is not necessary. At the

hearing, Defendants raised their concern that this phrase could be interpreted to include

the use of a hot water solution or some other solution to obtain the extract. The plain

language of the patent, however, includes only a concentrate of ethanol or ethanol

aqueous solution, so no further construction of this phrase on that point is necessary. 

//

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Disputed claim language Plaintiffs’ construction Defendants’ construction

ethanol The chemical compound

represented by the

empirical formula C2H6O

and variously represented

by the molecular formula

EtOH, CH3CH2OH and

C2H5O.

The chemical compound

represented by the

empirical formula C2H6O

and variously represented

by the molecular formula

EtOH, CH3CH2OH and

C2H5OH.

There is essentially no dispute about the meaning of this claim term. Defendants’

construction, however, contains the correctly formatted notations for ethanol. Therefore,

the Court adopts Defendants’ construction of this term. 

Disputed claim language Plaintiffs’ construction Defendants’ construction

ethanol aqueous solution Ethanol dissolved in water A solution of ethanol and

water

There is no real dispute about the meaning of this term. As the parties agreed at

the hearing, the Court adopts Defendants’ construction. 

Disputed claim language Plaintiffs’ construction Defendants’ construction

a corosolic acid content of

0.01 to 15 mg per 100 mg

of the concentrate

No construction necessary

because the proper

approach is to define the

terms of the phrase

having corosolic acid

content between .01 and 15

mg per 100 mg of the total

substance.

There is essentially no dispute about the meaning of this claim phrase. Plaintiffs

argue that Defendants’ construction does not add anything to or otherwise clarify the

plain language of the phrase. This phrase, which reflects the plain language in the

specification, needs no further construction, especially because terms within this phrase

will be construed separately. 

//

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Disputed claim language Plaintiffs’ construction Defendants’ construction

corosolic acid A member of the chemical

family of triterpenoids or

triterpines including 2-aHydroxyursolic acid;

Hydroxyursolic acid; and

2, 3-Dihydroxyurs-12-en28-olc acid having the

structural formula

[contained in the formula

shown in column two of

the patent].

Corosolic acid is one of the

triterpenoids having the

structural formula shown

in column 2 of the patent.

There is essentially no dispute about the meaning of this term. At the hearing,

Plaintiffs clarified that they included the additional language regarding triterpines in their

proposed construction to reflect information from experts regarding corosolic acid. This

language, however, is not found in the specification. Moreover, at the hearing, Plaintiffs

agreed that it is not necessary to have the language regarding triterpines in a construction

of this term. In addition, the specification itself contains a definition of corosolic acid,

and Plaintiffs have provided no reason to deviate from that. See ‘459 patent at col. 2 at

ll. 48-63. Therefore, the Court adopts Defendants’ construction as follows: “Corosolic

acid is one of the triterpenoids having the structural formula shown in column 2, lines 50-

63 of the patent.” 

Disputed claim language Plaintiffs’ construction Defendants’ construction

ethanol solution contains

50 to 80 by weight of

ethanol

An ethanol and water

solution which contains,

by weight, between 50

percent ethanol and 80

percent ethanol

Agreed

The parties agree on the construction of this term. Therefore, the Court adopts

Plaintiffs’ construction.

IT IS SO ORDERED.

Dated: July 24, 2007 

ELIZABETH D. LAPORTE

United States Magistrate Judge

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