Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-alnd-2_00-cv-02430/USCOURTS-alnd-2_00-cv-02430-0/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

NORTHERN DISTRICT OF ALABAMA

SOUTHERN DIVISION

CENTRAL ADMIXTURE )

PHARMACY SERVICES, INC., )

and GERALD BUCKBERG, )

)

Plaintiffs, ) CASE NO. CV-00-2430-VEH

)

v. )

)

ADVANCED CARDIAC )

SOLUTIONS, P.C., and )

CHARLES WALL, )

)

Defendants. )

MEMORANDUM OF OPINION

Before the court are four motions for summary judgment,filed by the plaintiffs,

Central Admixture Pharmacy Services, Inc. (“CAPS”), and Gerald Buckberg; and two

motions for summary judgment and one motion for judgment on the pleadings, filed

by the defendants, Advanced Cardiac Solutions, P.C. (“ACS”), and Charles Wall. 

The instant cause is a civil action for the infringement of U.S. Patent Number

4,988,515 (the “‘515 patent”). The plaintiffs are, Dr. Gerald Buckberg, the inventor

and alleged owner of the patent, and CAPS, the exclusive licensee of the patented

invention. In their complaint, the plaintiffs assert a cause of action under federal

patent law, 35 U.S.C. §§ 281, et seq., against the defendants ACS and Charles Wall

FILED

 2006 Jan-10 PM 03:13

U.S. DISTRICT COURT

N.D. OF ALABAMA

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for infringement of the ‘515 patent by producing, commercially marketing, and

selling directly infringing products, and by inducing others to infringe the patent by

producing infringing products.

In their Third Amended Answer and Counterclaim, the defendants assert

several defenses to the plaintiffs’ patent infringement claim as well as three

counterclaims of their own. In Counterclaim I, the defendants seek a declaration that

the ‘515 patent is unenforceable and, alternatively, that the defendants did not

infringe the patent. In Counterclaim II, the defendants assert a cause of action under

35 U.S.C.A. § 292 for false marking. In Counterclaim III, the defendants assert a

cause of action for false advertising under the Lanham Act, 15 U.S.C.A. §

1125(a)(1)(b).

In the instant motions filed by the defendants, the defendants seek judgment

on the plaintiffs’ claim of infringement on three separate grounds. In the first motion

(doc. 219), the defendants seek judgment on the pleadings on the ground that the

plaintiffs do not have title to the patent. In the second motion (doc. 233), the

defendants move for summary judgment based upon the defense that the plaintiffs

engaged in inequitable conduct in the procurement of the patent. In the third motion

(doc. 235), the defendants seek partial summary judgment on the ground that the

plaintiffs have failed to adduce any evidence that the defendants infringed the ‘515

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patent prior to the issuance of the Certificate of Correction. 

In the instant motions for summary judgment filed by the plaintiffs, the

plaintiffs seek judgment on their claim of infringement, on the defendants’ three

counterclaims, and on an unpled counterclaim for violations of the Sherman AntiTrust Act. In the plaintiffs’ first motion (doc. 221), they seek summary judgment on

their claim of infringement and against the defendants’ counterclaim for a declaration

of no infringement. In the plaintiffs’ second motion (223), they seek summary

judgment on the defendants’ defense that the ‘515 patent is invalid. In the plaintiffs’

third motion (doc. 226), the plaintiffs seek summary judgment on the defendants’

counterclaim of false marking and false advertising under Lanham Act. In the

plaintiffs’ fourth motion (doc. 229), they seek summary judgment on the defendants’

affirmative defense of inequitable conduct, patent misuse, and on an unpled

counterclaim under the Sherman Anti-Trust Act.

These motions were opposed, fully briefed, and were taken under submission

by the court on July 26, 2005. 

SUMMARY OF DISPOSITION

For the reasons below, the court rules as follows:

1. The defendants’ motion for judgment on the pleadings for lack of

ownership of the ‘515 patent (doc. 219) is DENIED;

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Because the plaintiffs’ motion for summary judgment on the defendants’ unpled 1

counterclaim of antitrust violation (doc. 229) is DENIED AS MOOT, the plaintiffs’ fourth

motion for summary judgment (doc. 229) is GRANTED IN PART as to defendants’ defenses of

inequitable conduct and patent misuse and DENIED IN PART as to the defendants’ unpled

antitrust counterclaim. The defendants failed to plead a counterclaim for violations of the federal

antitrust laws, and the claim simply is not before the court.

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2. The plaintiffs’motion for summary judgment asto the defendants’ claim

of inequitable conduct and patent misuse (doc. 229) is GRANTED and 1

the defendants’ motion for summary judgment on inequitable conduct

(doc. 233) is DENIED;

3. The plaintiffs’ motion forsummary judgment as to the defendants’ claim

of that the ‘515 patent is invalid on grounds of obviousness (doc. 223)

is GRANTED;

4. The plaintiffs’ motion for summary judgment on its claim of

infringement (doc. 221) is DENIED IN PART and GRANTED IN

PART as follows: summary judgment is granted as to whether the

defendants willfully infringed the ‘515 patent provided that the

certificate of correction is found to be valid; summary judgment is

denied as to whether the certificate of correction is valid;

5. The defendants’ partial motion for summary judgment of no

infringement prior to the issuance of the certificate of correction (doc.

235) is DENIED;

6. The plaintiffs’ motion for summary judgment on the second

counterclaim of false marking and third counterclaim of false

advertising (doc. 226) is GRANTED. 

PROCEDURAL BACKGROUND

The plaintiff CAPS commenced this action on August 31, 2000, by filing a

complaint with this court asserting a cause of action for patent infringement under

federal patent law. Fact discovery in this case initially closed on August 17, 2001.

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On April 30, 2002, the court conducted a Markman hearing to construe the

claims of the ‘515 patent. On May 2, 2002, the court issued its Markman order

construing the claims of the patent. On November 21, 2003, the plaintiffs filed their

motions for summary judgment. On December 8, 2003, the court extended the

deadline for filing dispositive motions until March 23, 2004. On March 23, 2004, the

date of the dispositive motion deadline, the defendants filed two motions for summary

judgment, as well as a motion to dismiss and a motion regarding claim construction.

On September 1, 2004, the defendants filed an additional motion for summary

judgment on the previously unraised grounds of inequitable conduct and common law

fraud, along with a “supplemental” motion for summary judgment on the ground of

patent invalidity.

On November 29, 2004, the court entered an order denying the defendants’

motion to dismiss for lack of standing. However, the court agreed with the

defendants’ argument that CAPS, the exclusive licensee of the patented technology,

was required to join the inventor, Dr. Gerald Buckberg, as a plaintiff to the action to

comply with statutory, as opposed to constitutional, standing requirements. On

December 15, 2004, Dr. Buckberg was joined as a plaintiff in the action. On January

7, 2005, the court gave the defendants 60 days to conduct discovery on Dr. Buckberg.

Due to the additional discovery and the passage of time, on March 3, 2005, the

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court denied all of the parties’ previously filed summary judgment motions. On May

5, 2005, the court required that new motions for summary judgment be filed by June

6, 2005. The parties filed six new motions for summary judgment on the date of the

deadline. In addition, on May 23, 2005, the defendants also filed a motion for

judgment on the pleadings. On July 26, 2005, the court took those summary

judgment motions and the motion for judgment on the pleadings under submission.

They are now before the court.

THE TECHNOLOGY

The invention at the heart of this dispute is called a cardioplegic solution.

Cardioplegic solutions are chemical solutions used during open-heart and other kinds

of stop-heart surgical procedures. One type of cardioplegic solution is used to stop

the heart and reduce its energy demands. While the heart is stopped, the patient is

sustained on a cardiopulmonary by-pass machine, which maintainsthe circulation of

oxygenated blood through the body. Meanwhile, another cardioplegic solution is

used to protect the heart from muscle damage, called ischemia, while the heart is

stopped. At the conclusion of the operation, a different cardioplegic solution is

infused to start the heart beating again and to prepare the heart for the return of

normal blood flow, a process called reperfusion.

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The ‘515 patent originally provided for the invention to have an osmolarity of between 2

about 400-500 mOsmol. On January 30, 2001, the United States Patent and Trademark Office

issued a certificate of correction changing every instance of osmolarity in the ‘515 patent to

osmolality. Although the question of the certificate of correction’s validity is centrally disputed

in this action, for purposes of providing the background of the dispute, the court refers to the

‘515 patent as altered by the certificate of correction.

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THE ‘515 PATENT

The invention covered by the ‘515 patent is described as a “cardioplegic

solution.” Commercially, the invention is known as a “Buckberg Solution”

(hereinafter the “Invention” or the “Buckberg Solution”) and is named for the

inventor, the plaintiff Dr. Buckberg. The patent involves two varieties of

cardioplegic solutions: high potassium solutions, which are used initially to stop the

heart’s beating at the beginning a stop-heart surgical operation, and low potassium

solutions, which are used to protect the heart from muscle damage during the surgery.

These solutions are called “blood cardioplegic” solutions because the solutions are

mixed with the patient’s blood before they are infused into the patient’s heart.

The ‘515 invention consists of an amino acid enriched cardioplegic solution

with (1) a calcium ion concentration of between 50-300 umol; (2) a concentration of

metabolizable substrate between about 400-1000 mg%; and (3) an osmolality of

between about 400-500 mOsmol/kg. Because blood usually has a calcium 2

concentration of 1000 umol, a calcium content of 50-300 umol is considered

hypocalcemic. Although the patent allows for several varieties of metabolizable

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Osmolarity, by contrast, refers to the number of particles of solute per liter of solution 3

and is denoted by the abbreviation mOsmol/L.

8

substrates, the metabolizable substrate used most often appears to be glucose. A

solution having a concentration of glucose between about 400-1000 mg% would fall

within the ‘515 patent’s second criterion. Osmolality refers to the number of particles

of solute per kilogram of water in the solution and is denoted by the abbreviation

mOsmol/kg. Because blood usually has an osmolality of approximately 280-300 3

mOsmol/kg, the levels of osmolality in described by the ‘515 patent (between about

400-500 mOsmol/kg) are considered moderately hyperosmotic.

In addition, because the Buckberg Solution is an amino acid enriched solution,

it contains 10-30 mmol of the amino acid aspartate and 10-30 mmol of the amino acid

glutamate. The solution must have a pH of between 7.5 and 7.7. The Buckberg

Solution generally contains blood, but the ‘515 patent covers solutions involving a

“carrier” or “cardioplegic compatible diluent” otherthan blood as well. However, for

the purposes of this action, the only relevant carrier or diluent involved is blood.

The ‘515 patent has three independent claims: claims 1, 7, and 13. Claim 1has

seven dependent claims (Claims 2-6, 18) and patents specific types of cardioplegic

solutions. Claim 7 has five dependent claims (Claims 8-12) and patents methods for

treating hearts with cardioplegic solutions. Claim 13 has four dependent claims

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(Claims 14-17) and patents concentrated aqueous solutions that need to be diluted to

become cardioplegic solutions. As mentioned above, for purposes of this action, the

concentrated aqueous solution referred to in Claim 13 will be diluted with blood to

become a cardioplegic solution. 

Under all three of the ‘515 patent’s independent claims, the solution, the

treatment, and the aqueous solution adapted to be diluted must contain (1) a calcium

ion concentration of between 50-300 umol; (2) a concentration of metabolizable

substrate between about 400-1000 mg%; and (3) an osmolality of between about 400-

500 mOsmol/kg.

I.

Ownership of the ‘515 Patent

The defendants moved for judgment on the pleadings on the ground that the

plaintiffs do not own the ‘515 patent. The facts relevant to this motion are set out

below. 

A. Facts

Dr. Buckberg created the Buckberg Solution at some point between 1979 and

1985. During this period, Dr. Buckberg was an employee of the University of

California. He developed the solution while conducting research pursuant to National

Institutes of Health (“NIH”) research grant number HL-16292. On August 2, 1985,

Dr. Buckberg conveyed his interest in the Buckberg Solution to the University of

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California.

On August 21, 1985, Dr. Buckberg applied for a patent on the Buckberg

Solution. In the patent application, Dr. Buckberg named himself as the inventor. On

December 13, 1985, the Regents of the University of California granted the United

States a nonexclusive, nontransferable, irrevocable, royalty-free license to use the

Buckberg Solution. (Def. Ex. E.)

On March 11, 1987, Dr. Buckberg requested a waiver of patent rights from the

NIH. On September 23, 1987, the Assistant Secretary for Health, Dr. Robert E.

Windom, issued a waiver of patent rights with respect to the Buckberg Solution. The

waiver provided that Buckberg was “free to retain and administer the patent rights to

the invention in accordance with the requirements of 37 C.F.R. § 401.9” and that “the

inventor shall grant to the government of the United States a nonexclusive,

irrevocable, royalty-free license to use the invention for government purposes.” (Def.

Ex. G.) 

In response to the defendants’ requests for admissions, Dr. Buckberg admitted

that he “did not execute a license to the United States Government in the invention

covered by US Patent 4,988,515 at any time between 1987 and 1991.” (Def. Ex. I.)

On January 29, 1991, the PTO issued patent ‘515, which covered the Buckberg

Solution. (Def. Ex. C.) The ‘515 patent lists Dr. Buckberg as the inventor and the

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Because the defendants’ motion is based almost entirely upon documents not included 4

within the pleadings, the defendants’ motion for the most part is a motion for summary

judgment. To the extent that the defendants base their arguments on documents outside the

pleadings, the court will evaluate the motion under the standard governing summary judgment set

out infra.

The defendants also move for judgment on the pleadings on the ground that the plaintiffs 5

failed to specifically allege that Dr. Buckberg owns the ‘515 patent. Not only is this argument

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Regents of the University of California as the assignees. (Id.) The ‘515 patent further

provides that “the invention was made with Government support under Grant No. HL

16292 awarded by the National Institutes of Health. The Government has certain

rights in this invention.” (Id.) On June 24, 1991, the Regents of the University of

California assigned their rights to the patent to Dr. Buckberg. (Pla. Ex. FFF.)

B. Legal Standard

Judgment on the pleadings is proper when no issues of material fact exist and

the movant is entitled to judgment as a matter of law. See Ortega v. Christian, 85 F.

3d 1521, 1524-25 (11th Cir. 1996).4

C. Analysis

The defendants’ motion for judgment as a matter of law is based on the

argument that Dr. Buckberg failed to perfect his title to the invention due to his

failure to comply with the Bayh-Dole Act, 35 U.S.C.A. §§ 200-12, the related agency

regulations, and the requirements in the NIH’s waiver of patent rights that Buckberg

execute a license in favor of the United States. (See Def. Ex. G.) With respect to the 5

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frivolous, but the defendants are estopped from making it. Earlier in the litigation, the

defendants moved for dismissal on the basis that Dr. Buckberg, the patent owner, had not been

joined as a plaintiff to the action. In course of advancing that argument, the defendants

unequivocally asserted that “The patent is owned by Gerald Buckberg.” (See Defs.’ Mot. to

Dismiss, doc. 79, at 3.) Having induced the court to order the joinder of Dr. Buckberg on the

basis of that argument, the defendants now are estopped from complaining about the inadequacy

of the plaintiffs’ pleading with regard to Dr. Buckberg’s ownership of the ‘515 patent.

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Bayh-Dole Act, the defendants argue that the Act required Dr. Buckberg to grant the

United States a paid-up, irrevocable license to use the Buckberg Solution, and that,

because Buckberg failed to do so, he lacks title to the ‘515 patent.

The Bayh-Dole Act, 35 U.S.C.A. §§ 200-12, governs the patent rights of

inventions made with federal assistance. For the act to apply, a party must be a

contractor who enters into funding agreements with federal agencies and who reduces

to practice an invention, called a subject invention, in the performance of the work

under the funding agreement. Here, there is no dispute that the University of

California is both a contractor and a nonprofit organization, within the meaning of

sections 201(c) and (i) of the Act, and that the Buckberg Solution is a subject

invention that was reduced to practice during the performance of work under a

funding agreement with a federal agency. The Act therefore applies. The analysis

moves to the questions of whether the Act was violated, and if so, what the

consequence of the violation must be.

Section 202(c)(1) requires a contractorto disclose within a reasonable time any

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subject invention to the federal agency that issued the funding agreement. See 35

U.S.C.A. § 202(c)(1). Federal regulations define a reasonable time as within two

months of the date the invention was created. See 48 C.F.R. § (c)(1). After the

invention is disclosed to the federal agency, the Act requires the contractor to “make

a written election within two years after disclosure to the federal agency . . . whether

the contractor will retain title to a subject invention.” 35 U.S.C.A. § 202(c)(2). If the

contractor elects to retain title, section 202(c)(5) provides that “the Federal agency

shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice

or have practice for or on behalf of the United States any subject invention

throughout the world.” Federal regulations further require a contractor to “agree to

execute or to have executed and promptly deliver to the Federal Agency all

instruments necessary to (I) establish or confirm the rights the government has

throughout the world in those subject inventions to which the Contractor elects to

retain title . . . .” 48 C.F.R. § 52.277(f)(1)(I). The regulations further require the

contractor to “include . . . within a patent issuing thereon covering the subject

invention, the following statement, ‘The invention was made with Government

support under (identify the contract) awarded by (identify the Federal agency). The

Government has certain rights in the invention.’” Id. § 52.277(f)(4).

There is no dispute here that the University of California complied with each

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of these requirements. The University timely disclosed the Buckberg Solution to the

NIH. On December 13, 1985, it executed a confirmation of the NIH’s paid-up,

irrevocable license to the invention. (See Def. Ex. E.) The ‘515 patent contains the

statement required by regulation section 52.277(f)(4). 

However, in 1987, the University ofCalifornia decided to forgo its rights to the

Buckberg Solution. At that point,Dr. Buckberg requested, pursuant to section 202(d)

of the Bayh-Dole Act, to obtain the NIH’s permission to seek patent rights in his own

name. Section 202(d) provides: “If the contractor does not elect to retain title to a

subject invention in cases subject to this section, the Federal agency may consider and

after consultation with the contractor grant requests for retention of rights by the

inventor subject to the provisions of this Act and regulations promulgated hereunder.”

35 U.S.C.A. § 202(d). Among the regulations promulgated under the Act is 37 C.F.R.

§ 401.9, which provides that “[a]gencies which allow employee/inventor of the

contractor to retain rights to a subject invention made under a funding agreement with

a small business or nonprofit organization, as authorized by 35 U.S.C.A. § 202(d),

will impose upon the inventor at least those conditions that would apply to a small

business contractor under paragraphs (d)(1) and (3); (f)(4); (h); and (j) of the clause

at § 401.14(a).” 37 C.F.R. § 401.9. 

On September 23, 1987, the NIH assented to Dr. Buckberg’s request to retain

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title to what would become the Buckberg Solution. However, the NIH’s assent stated

that “the inventor shall grant to the Government of the United States a nonexclusive,

irrevocable, royalty-free license to the invention for government purposes.” The

defendants have submitted to the court Dr. Buckberg’s admission that he did not

execute a such license. Although Rule 37(b) permits a party to move to withdraw or

amend an admission, the plaintiffs failed to file such a motion prior to the close of

discovery. Consequently, even though Dr. Buckberg has provided, in opposition to

this instant motion, a declaration that he did execute a license to the government,

under Federal Rule 37(b), the court is obligated to treat Dr. Buckberg’s admission as

“conclusively establish[ing]” that he did not execute any such license.

The defendants, therefore, have shown that Dr. Buckberg has failed to comply

with the Bayh-Dole Act. The question, therefore, moves to what the Act prescribes

as consequence of Dr. Buckberg’s noncompliance. 

The defendants argue that Dr. Buckberg’s noncompliance entails that Dr.

Buckberg never obtained title to the ‘515 patent. The problem with the defendants’

argument, however, is that this consequence is nowhere mentioned in the Act.

Rather, the only consequence mentioned in the Act for failing to comply with its

requirements is that the federal government will retain the right to receive title to the

invention. For instance, if a contractor entirely fails to disclose the existence of an

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invention to the relevant federal agency, the Act provides that “the Federal

Government may receive title to any subject invention not disclosed to it within such

time.” 35 U.S.C.A. § 202(c)(1) (emphasis added). Similarly, if a party fails to make

a timely written election of its intent to retain title to the subject invention, the Act

provides that “the Federal Government may receive title to any subject invention in

which the contractor does not elect to retain rights or fails to elect within such time.”

35 U.S.C.A. § 202(c)(2) (emphasis added). The Federal Circuit has confirmed that

the phrase “the Federal Government may receive title” means that the federal

government has discretion to determine whether to take title to the invention. See

Campbell Plastics Eng’g & Mfg., Inc. v. Brownlee, 389 F.3d 1243, 1250 (Fed. Cir.

2004) (“We agree with the [Armed Services] Board [of Contract Appeals] that FAR

52.227.11(d) vests discretion in the government in determining whether to invoke

forfeiture when an invention has not been correctly disclosed to it.”).

In support of their argument that the Act divests Buckberg of title, the

defendants rely on TM Patents, L.P. v. IBM Corp., 121 F. Supp. 2d. 349, 368-69

(S.D.N.Y. 2000). However, the court will not follow TM Patents because it is at odds

with Campbell Plastics. Whereas Campbell Plastics states that a violation of the

Bayh-Dole Act gives the Federal Government discretion to take title to a subject

invention, see 389 F.3d at 1250 TM Patentsstatesthat the forfeiture is automatic. See

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Furthermore, the TM Patents decision is not persuasive because its legal conclusions are 6

not supported by the authorities upon which the decision relies. In support of the proposition that

the Bayh-Dole Act operates an automatic forfeiture on the patent rights of parties who do not

fully comply with the Act, the TM Patents court relies on the following quotation from

Thermalon Industry, Ltd. v. United States, 34 Fed. Cl. 411, 414 (Fed. Cl. 1995): “NSF [a

government entity] acquires title to a patent, rather than a license, inter alia, in the event the

grantee fails to disclose within a reasonable time that the patented invention resulted from the

grant.” Although the TM Patents court relies on this quotation as an authoritative interpretation

of the Bayh-Dole Act, the quotation is no such thing. Instead, the quotation is part of a recitation

of the provisions of a contract between the National Science Foundation (NSF) and Thermalon

Industries. The Thermalon court was not even attempting to construe the Bayh-Dole Act, much

less give an authoritative interpretation of it. Indeed, the Thermalon case was a breach of

contract action for damages having nothing to do with patent rights. Thus, the TM Patents

opinion is contrary to the language of the Act, contrary to the binding authority of the Federal

Circuit, and unsupported by the authority to which it cites. 

17

121 F. Supp. 2d. at 368-69 (“Failure to comply with the conditions of § 202 results

in the Government acquiring title.”). On this question of patent law, this court is

obligated to follow the Federal Circuit’s authority as against the Southern District of

New York.6

Based on the language of the statute and its interpretation by the Federal

Circuit, the court determines that Dr. Buckberg’s failure to comply with the BayhDole Act leavesthe patent subject to the Federal Government’s discretionary right to

take title to the ‘515 patent. In addition to the fact that this outcome is supported by

the statutory language and applicable case law, the court finds that this conclusion

furthers the purpose of the Bayh-Dole Act by interpreting the law to preserve the

government’s rights to inventions created through government funding and also by

declining to interpret the law to provide additional defenses to alleged patent

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infringers.

Because the defendants have failed to present any evidence that the NIH has

taken title to the ‘515 patent, the court finds that the defendants are not entitled to

judgment on the ground that Dr. Buckberg is not the owner of the patent.

Accordingly, the defendants’ motion for judgment on the pleadings for lack of

ownership of the ‘515 patent is due to be DENIED.

II.

The Validity of the ‘515 Patent

The plaintiffs move for summary judgment as to the defendants’ counterclaim

and affirmative defenses that the ‘515 patent is invalid. 

A. Summary Judgment Standard

Under Federal Rule of Civil Procedure 56(c), summary judgment is proper “if

the pleadings, depositions, answers to interrogatories, and admissions on file, together

with the affidavits, if any, show that there is no genuine issue as to any material fact

and that the moving party is entitled to judgment as a matter of law.” Celotex Corp.

v. Catrett, 477 U.S. 317, 322 (1986); Chapman v. AI Transport, 229 F.3d 1012, 1023

(11th Cir. 2000). The party asking for summary judgment always bears the initial

responsibility of informing the court of the basis for its motion and identifying those

portions of the pleadings or filings which it believes demonstrate the absence of a

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genuine issue of material fact. Celotex Corp., 477 U.S. at 323. Once the moving

party has met his burden, Rule 56(e) requires the nonmoving party to go beyond the

pleadings and by his own affidavits, or by the depositions, answers to interrogatories,

and admissions on file, designate specific facts showing that there is a genuine issue

for trial. Id. at 324. 

All reasonable doubts about the facts and all justifiable inferences are resolved

in favor of the non-movant. Chapman, 229 F.3d at 1023; Fitzpatrick v. City of

Atlanta, 2 F.3d 1112, 1115 (11th Cir. 1993). A dispute is genuine “if the evidence

is such that a reasonable jury could return a verdict for the nonmoving party.”

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); Chapman, 229 F.3d at

1023. If the evidence is merely colorable, or is not significantly probative, summary

judgment may be granted. Anderson, 477 U.S. at 249.

On a motion forsummary judgment, the burden of proof that applies is the “the

evidentiary standard of proof that would pertain at a trial on the merits.” Eli Lilly &

Co. v. Barr Labs., Inc., 251 F.3d 955, 962 (Fed. Cir. 2001). Because patents are

entitled at law to a presumption of validity, see 35 U.S.C.A. § 282, a moving party

seeking to have a patent held not invalid at summary judgment must show that the

nonmoving party, who bears the burden of proof at trial, failed to produce clear and

convincing evidence of invalidity so that no reasonable jury could invalidate the

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patent. Id. Additionally, when a party attacks a patent based upon prior art that was

considered by the PTO, “he has the added burden of overcoming the deference that

is due to a qualified government agency presumed to have properly done its job,

which includes one or more examiners who are assumed to have some expertise in

interpreting the references and to be familiar from their work with the level of skill

in the art and whose duty it is to issue only valid patents.” Am. Hoist & Derrick Co.

v. Sowa & Sons, Inc., 725 F.2d 1350, 1359 (Fed. Cir. 1984). 

B. Facts

As described above, the Buckberg Solution consists of an amino acid enriched

cardioplegic solution having (1) a calcium ion concentration of between 50-300 umol;

(2) a concentration ofmetabolizable substrate between about 400-1000 mg%; and (3)

an osmolality of between about 400-500 mOsmol/kg. At these levels, the solution

combines the characteristics of being hypocalcemic, hyperglycemic, and

hyperosmotic, and it possesses these characteristics within the precise ranges claimed

in the patent.

The prior art in the area of cardioplegia that form the basis of the defendants’

claims of invalidity are as follows. In 1978, Dr. David Follette, et al., published in

the journal Surgical Forum an article describing a cardioplegic solution that was

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 20 of 67
The defendants’ expert, Dr. Robert Riggs, reports that .5 mEq/L converts to 250 umol 7

calcium.

21

hypocalcemic (.5 mEq/L calcium) . The solution described by Dr. Follette was not 7

amino acid enhanced. In 1979, Dr. Buckberg published an article entitled “A

Proposed ‘Solution’ to the Cardioplegic Controversy” in which he disclosed a

solution that was hypocalcemic (500 umol calcium) and moderately hyperosmotic

(>400 mOsmol/L). 

In 1980, in what the parties refer to as the “Dyson Reference,” Drs. Buckberg

and Charles Dyson described their “standard cardioplegic solution” as being

hyperosmotic (360 mOsmol/L) and hypocalcemic with a metabolizable substrate, in

this case dextrose, of over 2000 mg%. The Dyson Reference was later updated and,

in 1982, it was published as Chapter 22 of the Textbook on Clinical Cardioplegia (the

“Chapter 22 Reference”). Neither the Dyson Reference nor the Chapter 22 Reference

describe solutions that are amino acid enhanced.

In 1981, Dr. David Follette, et al., published an article where the authors

described a cardioplegic solution that was hypocalcemic and hyperosmotic, but at

various levels of calcium concentration and levels of osmolarity. The article endorses

as “ideal” a calcium concentration of 500 umol and an osmotic pressure of 351 +/-5

mOsmol/L. However, the article did not disclose any amount of glucose or other

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 21 of 67
The defendants’ expert, Dr. Riggs, states that 10 gm/L of glucose would produce a 8

glucose concentration of approximately 1000 mg%. (See Riggs Decl. (doc. 239, Defs. Ex. 2) ¶

11.) 

Dr. Riggs, the defendants’ expert, lists additional references as relevant prior art, but 9

there is no dispute that the remaining references, including the Menasche 1984, the Irasawa 1983,

and the Bercot 1979 References disclose cardioplegic solutions that differ in material respects

from the Buckberg Solution. Reflecting this, in their brief opposing summary judgment, the

defendants make no arguments based upon these additional references. 

22

metabolizable substrate in the solution, nor was it amino acid enriched.

In 1982, Dr. Phillip Menasche, et al., published an article wherein the authors

disclosed a cardioplegic solution that was hypercalcemic (2500 umol calcium),

moderately hyperosmotic (395 mOsmol/L), and hyperglycemic (10 gm/L glucose).8

Menasche based his solution on a 1981 article by Dr. Follette, although Menasche’s

solution also was amino acid enriched and contained glucose. The Menasche article

described a clinical trial testing a procedure called retrograde coronary sinus

profusion as a means of delivering cardioplegia.

In 1983, Dr. Kito published an article describing a cardioplegic solution that

was hyperglycemic with a glucose range of 2500-3500 mg%. In 1983, Dr.

Rosenkrantz described a cardioplegic solution that was hypocalcemic (500 umol

calcium) and moderately hyperosmotic (360 mOsmol/L) but that did not disclose any

glucose concentration or recommend amino acid enrichment. In 1984, Dr. Hashimoto

disclosed a cardioplegic solution containing 2000 mg% of glucose.9

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 22 of 67
23

The application that led to the ‘515 patent was filed on August 21, 1985. On

November 20, 2003, the defendants filed a Request for Ex Parte Reexamination of

the ‘515 Patent with the PTO. All of the references cited in the Information

Disclosure Statements submitted during the reexamination proceedings were

considered by the Examiner. On February 10, 2005, a Notice of Intent to Issue Ex

Parte Reexamination Certificate was issued by the Examiner. The Examiner stated

that “[n]one of the references, either taken individually or taken as a whole, suggest

the cardioplegia solution within the limitations claimed.” (See Notice of Intent to

Issue Reexamination Cert., Pla. Ex. JJ.)

C. Analysis

The defendants assert a counterclaim for a declaration that the ‘515 patent is

invalid and raise invalidity as an affirmative defense. The defendants’ claims of

invalidity are based upon anticipation under section 102 of the patent law, the public

use bar under section 102 of the patent law, indefiniteness under section 115 of the

patent law, and obviousness under section 103 of the patent law. 

1. Anticipation Under § 102

“Anticipation under 35 U.S.C.A. § 102 means lack of novelty, and is a question

of fact.” Beckson Marine, Inc. v. NFM, Inc., 292 F.3d 718, 725 (Fed. Cir. 2002). To

prevail on their claim that the ‘515 patent is void because it was anticipated, the

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 23 of 67
The plaintiffs object to the defendants’ reliance on this reference because it was not 10

disclosed until three years after the close of the original discovery deadline. Ordinarily, this

argument would prevail and the untimely disclosed evidence would be disregarded. See Sosa v.

Airprint Sys., Inc., 133 F.3d 1417, 1418 (11th Cir. 1998). However, because the court reopened

discovery in this action and permitted the parties to file new motions for summary judgment

based upon evidence produced in the most recent round of discovery, the court can see no

principled ground for viewing this evidence as untimely, nor can the court perceive that the

plaintiffs will suffer any prejudice by the court’s consideration of the reference given their

opportunity to conduct additional discovery on the reference.

24

defendants must show, by clear and convincing evidence, “that the four corners of a

single, prior art document describe every element of the claimed invention, either

expressly or inherently, such that a person of ordinary skill in the art could practice

the invention without undue experimentation.” Advanced Display Sys., Inc. v. Kent

State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000). 

The defendants predicate their claim of lack of novelty on an article authored

by Phillip Menasche, et al., published in 1982 in the Society of Thoracic Surgeons

journal. However, this reference plainly fails to support the defendants’ claim of

anticipation on two grounds. First, the solution described in the Menasche 1982

10

Reference discloses a calcium concentration of 2500 umol, which far exceeds the

Buckberg Solution’s claimed range of 50-300 umol. In fact, the Menasche solution

is significantly hypercalcemic rather than hypocalcemic. Although the defendants

argue that a person skilled in the art could add sufficient chelating agent to reduce the

calcium concentration to the ranges claimed in the ‘515 patent, there is nothing in the

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 24 of 67
25

text of the article to motivate a reader to do so. To the contrary, because the article

recommends formulating a solution that is strongly hypercalcemic to begin with, it

would be contradictory to view the article as disclosing or teaching or in any way

encouraging the formulating of a strongly hypocalcemic solution. 

Accordingly, the defendants have failed to provide clear and convincing

evidence creating an issue of fact as to whether the ‘515 patent is invalid for having

been anticipated. The plaintiffs are entitled to summary judgment on this ground.

2. Public Use Under § 102 

Section 102 of the patent law provides that a person “shall be entitled to a

patent unless . . . (b) the invention was . . . in public use or on sale in this country,

more than one year prior to the date of the application in the United States.” 35

U.S.C.A. § 102(b). As with any other challenge to the validity of a patent, the burden

of proof to prove public use of the patented invention more than a year prior to the

filing of the patent application is on the party attacking the patent. See TP Labs. v.

Professional Positioners, Inc., 724 F.2d 965, 971 (Fed. Cir. 1984). Furthermore, it

is well-established that “if a use is experimental, though not secret, ‘public use’ is

negated.” Id. 

The defendants base their claim of public use on an article that Dr. Buckberg

published in 1986 in The Journal of Thoracic and Cardiovascular Surgery. The

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 25 of 67
26

article reports that, from May 1984 to April 1985, patients were clinically treated at

UCLA and Long Beach Memorial Hospital for acute coronary occlusion with a

cardioplegic solution within the ranges within the ‘515 patent. Although Dr.

Buckberg testified that he did not remember whether he began treating the patients

with the cardioplegic solution before or after August 21, 1984, the defendants ask the

court to infer, on the basis of the article, that some use of the cardioplegia occurred

prior to this date.

The defendants’ reliance on the 1986 article fallsshort of clear and convincing

evidence from which a jury could find that the ‘515 patent is invalid due to public

use. It is well-established that experimental use of an invention does not constitute

public use under section 102(b). The fact that Dr. Buckberg published his findings

in a scientific journal strongly supports the conclusion that the use was experimental.

This conclusion is further supported by the fact that Dr. Buckberg relied on the data

obtained from the clinical trials to support his application for a patent on the

Buckberg Solution. (See ‘515 patent, at 2.) The defendants offer no evidence

contradicting the plain appearance that Dr. Buckberg’s clinical use of the invention

was experimental.

Accordingly, the plaintiffs are entitled to summary judgment on the defendants’

claims that the ‘515 patent is invalid due to public use under section 102 of the patent

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 26 of 67
The plaintiffs submitted, along with their reply brief, a declaration from Dr. Buckberg

11

indicating that the clinical treatment was secret, and therefore not public. However, the court

struck that declaration, along with several other pieces of evidence, because they were untimely

submitted under the Northern District of Alabama’s Uniform Guidelines Regarding Summary

Judgment. (See Order, dated July 26, 2005, doc. 266.)

27

law.11

3. Obviousness Under § 103

Section 103 of the patent law requires provides that “[a] patent may not be

obtained though the invention is not identically disclosed or described as set forth in

section 102 of this title, if the differences between the subject matter sought to be

patented and the prior art are such that the subject matter as a whole would have been

obvious at the time the invention was made to a person having ordinary skill in the

art to which said subject matter pertains.” 35 U.S.C.A. § 103(a). Obviousness is an

issue of law based upon four factual inquiries, to wit: “(a) the scope and content of

the prior art; (b) the differences between the prior art and the claims at issue; (c) the

level of ordinary skill in the art; (d) the objective evidence of nonobviousness.”

Custom Accessories, Inc. v. Jeffrey-Allen Indus., Inc., 807 F.2d 955, 958 (Fed. Cir.

1986). Furthermore, “when determining the patentability of a claimed invention

which combines two known elements, the question is whether there is something in

the prior art as a whole to suggest the desirability, and thus the obviousness, of

making the combination.” Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361,

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 27 of 67
See Holman Decl. (Pla. Ex. VV) ¶¶ 38-64. Furthermore, as the court ruled above, the 12

Menasche 1982 Reference has a calcium concentration that plainly exceeds the range claimed in

the ‘515 patent, and the defendants have produced no clear and convincing evidence that it

contains a glucose concentration within the claimed ranges.

28

1371 (Fed. Cir. 2000). However, one must not “use hindsight reconstruction to pick

and choose among isolated disclosures in the prior art to deprecate the claimed

invention.” Id. “[T]he court requires the challenger to show a motivation to combine

the references that creates the case of obviousness.” Beckson Marine, Inc. v. NFM,

Inc., 292 F.3d 718, 727-28 (Fed. Cir. 2002) (brackets omitted).

The defendants base their claim of obviousness on the opinion of Dr. Riggs,

on the twelve references cited in his expert reports, on the Dyson/Chapter 22

Reference, and on the Menasche 1982 Reference. With the exception of the

Menasche 1982 Reference that the court discussed above, there appears to be no

dispute that no single Reference embodies all of the ‘515 patent’s claims.12

Consequently, the defendants rely on an argument that the prior art reveals a

motivation to combine the elements present in the prior art in a way that obviously

would lead to the formulation of the Buckberg Solution. 

The defendants make this argument with a series of legal obstacles arrayed

against them. In addition to the patent possessing a statutory presumption of validity,

the finding of the PTO Examiner as expressed in the Reexamination Certificate itself

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 28 of 67
29

is evidence of the invention’s lack of obviousness, and the court is obligated to afford

the Examiner’s conclusion some deference. See Am. Hoist & Derrick Co., 725 F.2d

at 1359. Furthermore, the plaintiffs have adduced substantial objective evidence of

the invention’s nonobviousness. Regarding the invention’s commercial success, the

defendants not only admit that its success is substantial, but they acknowledge that

virtually no substitute products exist: “CAPS has an extremely strong position in the

outsourcing of cardioplegia and faces competition from only one or two major

companies and a handful of regional providers such as ACS. CAPS has no

competitors in the outsourcing of amino acid enriched cardioplegia except ACS, but

for ACS, no other substitute product exists.” (Defs. Opp. to Pla. 3d Mot. for Summ.

J at ¶ (B)(1)). 

Moreover, Charles Wall admitted that he copied Dr. Buckberg’s solution to

formulate ACS’ cardioplegia products. (Wall Dep. at 29-30, 48.) Additionally,

several prominent cardiovascular surgeons have filed declarations supporting the

nonobviousness of the Buckberg Solution in the prior art. Included among these

surgeons is Dr. Follette, who authored many of the references relied upon by the

defendants to support their claim of obviousness. (See Def. Ex. X.) 

Thus, to prevail against this evidence, defendants require extremely powerful

evidence of a motivation to combine to establish that the Buckberg Solution was

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 29 of 67
Although the defendants submit the opinion of Dr. Riggs that one can derive a 13

motivation to combine from the prior art, Dr. Riggs’s opinion does not prevent the granting of

summary judgment because obviousness is a question of law, not one of fact. See Custom

Accessories, Inc., 807 F.2d at 958. Thus, Dr. Riggs’s opinion, to the extent that it attempts to

establish that the Buckberg Solution was obvious in light of the prior art, amounts to an opinion

on an ultimate question of law. 

Furthermore, Dr. Riggs’s opinion is flawed because it attempts to demonstrate a

motivation to combine by focusing only on Dr. Buckberg’s prior publications, and using the

development in Dr. Buckberg’s writing to predict what Dr. Buckberg’s ideal solution would have

been in 1985. This approach is flawed because Dr. Riggs’s motivation for focusing exclusively

on Dr. Buckberg’s writing is his hindsight knowledge that Dr. Buckberg ultimately would

synthesize the cardioplegia patented by the ‘515 patent. The law is clear that using hindsight to

retrace the creation of an invention is an improper form of analysis to support a claim of

obviousness. See Beckson Marine, Inc., 292 F.3d at 727-28.

30

obvious in light of the prior art. Such evidence simply is lacking. Although it is 13

possible to cherry-pick from the prior art the elements that Dr. Buckberg synthesized

in the Buckberg Solution, each reference cited by the defendants teaches away from

the invention to the same degree that it teach towards it. 

The reason for this is that the prior art leading up the Buckberg Solution

reveals no discernable trend in the levels disclosed in cardioplegia. For instance, the

Menasche 1982, the Menasche 1984, and the Bercot 1979 References all teach

hypercalcemia (1250-2500 umol calcium) in cardioplegia. However, other references

published during the same period–such as Follette 1978, Follette 1981, the

Rosenkrantz 1983, and the Dyson/Chapter 22 References–counsel the opposite, i.e.,

hypocalcemia. Many references during this period contain no teaching on glucose,

see, e.g., Menasche 1984, Irisawa 1983, Follette 1981, Rosenkrantz 1983, Buckberg

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 30 of 67
As discussed above, the Menasche 1982 cardioplegic solution is the one disclosed in the 14

prior art that is most similar to the Buckberg Solution. However, the Menasche 1982 Reference

addresses a separate topic. The article lists the formula of the cardioplegic solution only once in

a table and it discloses the constituent elements of cardioplegia only briefly and incompletely in

the text. The article makes no references of any particular benefits arising from the particular

formulation used and it makes no attempt to encourage readers to use a similar solution. The

article provides no guidance whatever as to which of the cardioplegia’s elements should be

pursued and which should be rejected. Consequently, the article fails to provide any motivation

to reject its teaching on hypercalcemia, while accepting its teaching as to moderate

hyperosmolality and hyperglycemia.

31

1979, and Bercot 1979. Those that do contain teachings on glucose–e.g., Kito 1983,

Hashimoto 1984, Follette 1977, and Dyson/Chapter 22–teach hyperglycemia at

ranges far in excess of the ranges claimed in the ‘515 patent.

Reading the prior art references proffered by the defendants, the writing was

not on the wall. One could only produce the Buckberg Solution if one had the special

insight to know precisely which lines of the prior art to reject and which to accept.14

 As attested to by the nineteen surgeons who provided declarations to support the

nonobviousness of Dr. Buckberg’s invention during the application for a patent, Dr.

Buckberg alone possessed the rare insight necessary to separate the fruitful lines of

development from the futile. There is no clear and convincing evidence to the

contrary.

Given the mass of objective evidence as to nonobviousness, and in light of the

substantial legal presumptions in favor of validity, and the failure of the defendants

to demonstrate any expressly stated or inherent motivation to combine the prior art

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 31 of 67
32

to produce the invention, the plaintiffs are entitled as a matter of law to a judgment

that the ‘515 patent is not invalid for obviousness. Accordingly, the plaintiffs are

entitled to summary judgment as to the defendants’ claim that the patent is void for

obviousness under section 103.

D. Indefiniteness

The defendants argue that the ‘515 patent is void for indefiniteness. A patent

is unenforceably indefinite when one skilled in the art would not understand the

bounds of the claim when read in light of the specification. See Hybritech, Inc. v.

Monoclonal Antibodies, Inc., 802 F.2d 1367, 1385 (Fed. Cir. 1986). If the “claims

read in light of the specification reasonably apprise those skilled in the art of the

scope of the invention, § 112 demands no more.” Id. An assertion of indefiniteness

must be proved by clear and convincing evidence. See Northern Telecom, Inc. v.

Datapoint Corp., 908 F.2d 931, 941 (Fed. Cir. 1990). Close questions of

indefiniteness are “properly resolved in favor of the patentee.” Exxon Research &

Eng’g Co. v. United States, 265 F.3d 1371, 1380 (Fed. Cir. 2001). 

The defendants argue that the ‘515 patent is indefinite for two reasons. First,

they argue that the phrase “adapted to be diluted” is indefinite. Second, they argue

that the word “maintaining,” as used in the patent’s claims, is indefinite. 

The defendants’ indefiniteness challenges fail, however, because they lack any

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 32 of 67
33

evidentiary support. Critically, all the experts who have offered their opinions in this

action have been able to construe the claims of the ‘515 patent. Furthermore, the

defendant, Charles Wall, attests that he understood the claims of the ‘515 patent well

enough to design ACS’ products to avoid infringement. Thus, all the evidence

supports the conclusion that the claims of the ‘515 patent are not unenforceably

indefinite, and there is no probative evidence to the contrary. 

Accordingly, the plaintiffs are entitled to summary judgment on the defendants’

affirmative defense and counterclaim that the patent is unenforceably indefinite.

E. Conclusion

The plaintiffs’ motion for summary judgment as to the defendants’ affirmative

defense and counterclaim that the ‘515 patent is invalid is due to be GRANTED.

III.

Inequitable Conduct

Both parties move for summary judgment on the defendants’ claim of

inequitable conduct in the procurement of the ‘515 patent. 

A. Sufficiency of Defendants’ Pleadings

Federal Rule of Civil Procedure 9(b) states that claims alleging fraud must be

pled with particularity. Fed.R.Civ.P. 9(b). Inequitable conduct, while a broader

concept than fraud, must also be pled with particularity. Ferguson Beauregard/Logic

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 33 of 67
The Federal Circuit applies the law of the regional circuit where the case arises as to 15

procedural issues not unique to patent law, such as those under Rule 9(b). See Ferguson

Beauregard/Logic Controls, 350 F.3d at 1344.

34

Controls v. Mega Sys., 350 F.3d 1327, 1344 (Fed. Cir. 2003). Rule 9(b) states that

“[i]n all averments of fraud or mistake, the circumstances constituting fraud or

mistake shall be stated with particularity. Malice, intent, knowledge, and other

condition of mind of a person may be averred generally.” Fed.R.Civ.P. 9(b).

“Inequitable conduct includes affirmative misrepresentation of a material fact,

failure to disclose material information, or submission of false material information,

coupled with intent to deceive.” Semiconductor Energy Lab. Co. v. Samsung Elecs.

Co., 204 F.3d 1368, 1373 (Fed. Cir. 2000) (quotation and citation omitted). To

satisfy the particularity requirement of Rule 9(b), ACS must plead “(1) the precise

statements, documents, or misrepresentations made; (2) the time, place, and person

responsible for the statement; (3) the content and manner in which these statements

misled the Plaintiffs; and (4) what the defendants gained by the alleged fraud.”

Brooks v. Blue Cross & Blue Shield of Fla., Inc., 116 F.3d 1364, 1380-81 (11th Cir.

1997). Mere conclusory allegations of fraud are insufficient. Id. Allegations of

15

inequitable conduct must give CAPS notice of the particular misconduct alleged so

that it can defend against the charge. ACS must offer specific facts that CAPS can

either deny or controvert. See Weatherford Int’l, Inc. v. Casetech Int’l, Inc., No.

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 34 of 67
35

Civ.A.H.-0305383, 2005 WL 1745457, at *1 (S.D. Tex. July 25, 2005). In holding

that inequitable conduct must comply with Rule 9(b), the Federal Circuit has ruled

that it would not “infer facts to support a claim that must be pled with particularity.”

Ferguson Beauregard/Logic Controls, 350 F.3d at 1344.

In their Third Amended Answer and Counterclaim, the defendants asserted the

following allegations in relation to inequitable conduct:

Affirmative Defenses

. . .

11. Each claim of the ‘515 patent is void and

unenforceable by virtue of the failure of patentee to advise

the Patent Office of prior art which was material to the

examination of the application.

. . .

Counterclaims

. . .

9. Upon information and belief, during prosecution

of the ‘515 Patent, the patentee failed to disclose all of the

relevant prior art known to it, and thereby failed to satisfy

its duty of disclosure to the United States Patent and

Trademark Office. Additionally, by manipulation of

various measurements and units, the patentee sought to

mislead the Patent and Trademark Office regarding the

relationship between the claimed invention and the prior

art. The ‘515 Patent is unenforceable as a result of this

failure to disclose and/or inequitable conduct during the

prosecution of the patent.

. . .

19. The ‘515 Patent is invalid and unenforceable.

Third Amended Answer and Counterclaim, Affirmative Defenses, ¶ 11;

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 35 of 67
The defendants rely upon Great American Indemnity Co. v. Brown, 307 F.2d 307, 308 16

(5th Cir. 1962), for the proposition that objections under Rule 9(b) are waived if the objections

are not presented via a Rule 12 motion. Great American Indemnity Co. is distinguishable,

however, because it addresses the issue of pleading special damages and arises on an appeal after

the entry of judgment. The case does not, and cannot, stand for the proposition that a party

waives its 9(b) arguments if it moves for judgment on an inadequately pled defense for the first

time at the summary judgment stage. 

Furthermore, the court stands by its prior rulings that the defendants failed to show good

cause for amending its pleadings to make additional allegations of inequitable conduct after the

deadline for amending pleadings had passed.

Lastly, the defendants are mistaken to rely on the court’s Order, dated May 5, 2005 (doc.

214), as ruling that the defendants adequately pled a defense of inequitable conduct. That Order

merely ruled that defendants’ discovery was relevant under Rule 26(b)(1) to allegations made in

the defendants’ Third Amended Answer and Counterclaim. The Order did not, however, review,

analyze, or in any way rule upon the sufficiency of the defendants’ allegations of inequitable

conduct under Rule 9(b). 

36

Counterclaims, ¶¶ 9, 19.

These allegations fail to state a defense or claim of inequitable conduct with

particularity. The allegations do not provide the specific details required by Rule

9(b), such as the precise statements, documents, or misrepresentations made; the time,

place, and person responsible for the statement; or the content and manner in which

these statements misled the PTO. See Brooks, 116 F.3d at 1380-81. The allegations

fail to provide CAPS with specific facts to deny or controvert. Instead, the

allegations merely restate the elements of an inequitable conduct defense. They are

prototypical conclusory allegations. 

Accordingly, the defendants have failed to plead an inequitable conduct

defense with particularity as required by the Federal Circuit’s case law. The 16

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 36 of 67
37

plaintiffs are therefore entitled to judgment as a matter of law on the defendants’

counterclaims and defenses of inequitable conduct.

B. Alternative Ruling on the Merits 

Even if the defendants had adequately pled their claims of inequitable conduct,

the court nevertheless would grant the plaintiffs’ motion for summary judgment on

the claims on their merits. 

“Inequitable conduct includes affirmative misrepresentation of a material fact,

failure to disclose material information, or submission of false material information,

coupled with intent to deceive.” Semiconductor Energy Lab. Co. v. Samsung Elecs.

Co., 204 F.3d 1368, 1373 (Fed. Cir. 2000). ACS’s unpled claims of inequitable

conduct include an assertion that CAPS failed to disclose to the PTO the

Dyson/Chapter 22 Reference, and that CAPS misrepresented the data contained in

Figure 4 of the patent. 

ACS’s claim based upon the Dyson/Chapter 22 Reference fails because ACS

has adduced no evidence, much less clear and convincing evidence, showing that the

Dyson/Chapter 22 Reference was material or that it was omitted with the intent to

deceive. First, the Dyson/Chapter 22 Reference discloses no prior art that was not

already before the Examiner. Although the Dyson/Chapter 22 Reference discloses

a calcium concentration of 150 umol that is within the range claimed by the ‘515

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 37 of 67
38

patent, the Follette 1978 Reference does so as well. Furthermore, the Dyson/Chapter

22 Reference teaches a glucose concentration (approximately 2160 mg%) that far

exceeds the concentration of the ‘515 patent, although it mirrors glucose

concentrations disclosed in the prior art references that were before the patent

examiner, such as the Kito 1983, Hashimoto 1984, and Follette 1977 References.

Thus, the Dyson/Chapter 22 Reference is merely cumulative and not material. See

Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1574-75 (Fed. Cir.

1997) (no inequitable conduct where the uncited reference teaches no more than what

a reasonable Examiner would consider to be taught by the prior art already before the

PTO).

Second, ACS presents no evidence that Dr. Buckberg intentionally withheld

the references to deceive the Examiner as to the state of the prior art. The only

evidence of Dr. Buckberg’s intent indicates that the materials were omitted for

innocent reasons, i.e., because the subject of the Dyson/Chapter 22 Reference was not

the formula of the cardioplegia, but rather was the delivery system used to administer

the cardioplegia. (See Buckberg Decl., Pla. Ex. WW, ¶ 22; Holman Decl., Pla. Ex.

VV, ¶ 56.) 

Because there is no evidence of either materiality or intent to deceive, the

plaintiffs are entitled to judgment as to the defendants’ unpled defense and

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 38 of 67
Defendants base their argument of misrepresentation on the assertions (1) that the 17

research leading to the ‘515 patent is the same as the research reported in Article IX of the

Journal of Thoracic and Cardiovascular Surgery, and (2) that Article IX reports the data

differently from how the data is reported in the ‘515 patent. (See Def. Ex. Z (Bradley S. Allen,

M.D., et al., Studies of Controlled Reperfusion After Ischemia: IX. Reperfusate Composition:

Benefits of Marked Hypocalcemia and diltiazem on Regional Recovery, J. OF THORAC.

CARDIOVASC SURG. v. 92, at 564-572 (1986))). Apparently making them for the first time in

their summary judgment briefs, defendants fail to present any evidence to support either

assertion. 

39

counterclaim of inequitable conduct based upon the Dyson/Chapter 22 Reference.

The defendants’ second basis for their inequitable conduct claim is Figure 4 of

the ‘515 patent. The defendants allege that Figure 4 purports to record the results of

the use of a cardioplegic solution with an osmolarity of 400-500, when in reality the

solution had a osmolarity of 360-380 mOsmol. This claim fails, however, because 17

the defendants present no evidence, other than attorney speculation, that Figure 4

misstates anything, nor have defendants produced any evidence to indicate that, if a

misstatement was present, it was made intentionally. To the contrary, it is undisputed

that the article upon which the defendants rely to show that Figure 4 is incorrect was

submitted to the Examiner. (See Def. Ex. P.) This is strong evidence that Dr.

Buckberg did not intend to deceive the Examiner and the defendants have failed to

rebut it. Accordingly, the plaintiffs are entitled to summary judgment as to the

defendants’ counterclaim and defense of inequitable conduct based upon the alleged

misrepresentation contained in Figure 4. 

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40

C. Conclusion

The plaintiffs’ motion for summary judgment as to the defendants’

counterclaim and affirmative defense of inequitable conduct is due to be GRANTED.

IV.

Validity of the Certificate of Correction

Along with their motion on inequitable conduct, the defendants argue that the

certificate of correction is invalid. The defendants base their argument on Superior

Fireplace Co. v. Majestic Prods. Co., 270 F.3d 1358, 1375 (Fed. Cir. 2001), which

holds that a certificate of correction that corrects “mistakes of minor character” may

not correct a mistake that broadens a patent’s claims. Because the court already has

held that the certificate of correction issued on the ‘515 patent corrected “a mistake

of minor character,” (Order, dated May 2, 2002, doc. 64, at 1), the defendants argue

that the certificate is invalid because the certificate accomplished a broadening of the

scope of the patent. Furthermore, the defendants submit additional evidence that they

argue demonstrates that the COC expanded the claims of the ‘515 patent. However,

the court already has ruled that “the defendants may present the question of the

COC’s validity to the jury.” (Id.) 

To the extent that the defendants’ argument constitutes a request for the court

to revisit this ruling, the court declines the request. The defendants’ evidence tends

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41

to show that osmolarity and osmolality are not identical measures. (See, e.g., Riggs

Decl. (doc. 239, Defs. Ex. 2).) However, there continues to be a question of fact as

to whether “an increased level of between about 400-500 mOsmol/kg” is broader than

“an increased level of between about 400-500 mOsmol/L.” Accordingly, the

defendants’ motion for summary judgment on the validity of the certificate of

correction is due to be DENIED.

V.

Infringement

The defendants move for summary judgment on the plaintiffs’ claims of

infringement prior to the issuance of the certificate of correction (“COC”). The

plaintiffs move for summary judgment on the claims of infringement after the

issuance of the COC. Each motion is addressed in turn.

A. Legal Standard

Evaluating claims of infringement involves two steps, “(1) claim construction

to determine the scope and meaning of the claims asserted to be infringed, followed

by (2) a determination of whether the properly construed claim encompasses the

accused [device or] method.” See Robotic Vision Sys., Inc. v. View Eng’g, Inc., 189

F.3d 1370, 1373 (Fed. Cir. 1999). Because the plaintiffs’ claims of infringement are

before the court on summary judgment, the summary judgment standard laid out

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42

above applies. 

B. Claim Construction

The ‘515 patent has three independent claims: claims 1, 7, and 13. Each

independent claim describes treatment for the human heart for the purpose of

preventing and reversing muscle damage due to ischemia. Claim 1 describes the

patented treatment as “an amino acid enriched cardioplegic solution for use in treating

human hearts”; whereas claim 7 describes the treatment more generically as “a

method for treating human hearts”; while claim 13 describes the treatment as “[a]

composition of matter for introduction into human hearts”. All three independent

claims require: (1) a calcium concentration of “between about 50-300 umol,” (2) a

metabolizable substrate concentration of “between about 400-1000 mg%,” and (3) an

osmolality or osmolarity of “between about 400-500 mOsmol.” ‘515 patent at 8-10.

Following the Markman hearing, the court issued orders on May 2, 2002, and

again on September 4, 2003,construing the scope and meaning of the claim contained

in the ‘515 patent. In the September 2003 Order, the court determined that the word

“about” was to be given “its common sense meaning as a term of approximation,

including numbers both below and above the ranges specified in the ‘515 patent.”

Markman Order, dated Sept. 4, 2003. The court further ruled that the limitation

“between about 400-500” encompasses “a range of osmolarity or osmolality from

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Although the court issued its construction of the patent’s claims in its Orders of May 2, 18

2002, and September 4, 2003, the defendants now urge the court to amend its construction by

construing the term “maintaining” as used in the ‘515 patent’s claims 7 through 12. The

defendants assert that the court should construe the term “maintaining” to mean that the ‘515

patent is not infringed unless a solution is within the claimed ranges throughout the treatment

being administered to a patient. The defendants make this argument too late as the court already

has issued its claim construction of the ‘515 patent. In the interest of finality, the issue of

construction shall not be revisited or endlessly litigated. In addition, even if the asserted

construction of the term “maintaining” were considered, the court would reject it. It is

undisputed that it is impossible to measure the levels of cardioplegic solutions after they have

been administered to the patient. Thus, adopting the defendants’ proposed construction would

render the ‘515 patent uninfringeable due to the impossibility of measuring infringement. There

is no merit to a claim construction that yields such an absurd result. 

43

385-515.” Id.

18

 1. Application of the COC

The defendants move for summary judgment on the plaintiffs’ claims of

infringement of the patent prior to the issuance of COC. The defendants make this

motion in the alternative. Their primary position is that the COC does not apply to

this suit because the suit was filed prior to the issuance of the COC. The defendants

advance the instant motion for summary judgment only if the court rejects that

argument and rules that the COC applies to this action as well as to all causes of

action that accrued after the issuance of the COC. Accordingly, it would be

premature for the court to rule on the defendants’ instant motion without first

determining the threshold question of whether the COC applies to this suit at all.

Because the issue has been fully briefed by the parties, and because the resolution of

this issue is necessary to determine the infringement questions pending before the

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44

court, the court will address whether the COC applies to this action.

The parties agree that the Federal Circuit’s opinion in Southwest Software, Inc.

v. Harlequin Inc., 226 F.3d 1280 (Fed. Cir. 2000), provides the definitive authority

as to the application of the COC. However, the parties quarrel over the meaning and

effect of the Federal Circuit’s holding in that case. At issue is whether the Federal

Circuit held that a COC applies only to causes of action arising after the issuance of

the COC or whether the COC applies only to lawsuits filed after the COC’s issuance.

The confusion as to how to interpret the Federal Circuit’s opinion arises fromthe fact

that the Southwest opinion uses the terms “lawsuit” and “cause of action”

interchangeably throughout the opinion. Thus, the defendants quote the passages in

Southwest Software containing the phrase “lawsuit,” see, e.g., id. at 1294 (“We hold

that the certificate of correction that added the Program Printout Appendix is not to

be given effect in this pre-certificate lawsuit.”), while CAPS cites to the sentences

where the phrase “cause of action” is used. See, e.g., id. at 1294 (“The certificate of

correction is only effective for causes of action arising after it was issued.”).

The plaintiffs observe that the reason the Federal Circuit could use the terms

“cause of action” and “lawsuit” interchangeably in Southwest Software is that, under

the particular facts of that case, the terms had the same effect. The defendant in

Southwest Software ceased its allegedly infringing activity upon the filing of the

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45

lawsuit. See id. at 1287. Because the relevant certificate of correction in that case

issued while the suit was pending, the plaintiff’s lawsuit was filed, and all of the

plaintiff’s causes of action arose, prior to the COC’s issuance. In contrast to the

instant action, the Federal Circuit in Southwest Software did not confront a situation

where some of the plaintiffs’ causes of action arose prior to the issuance of the COC

and some arose after its issuance. Because of these particular facts, Southwest

Software must be interpreted with care.

Pursuant to such a careful reading, the court finds that the Southwest Software

opinion supports the interpretation that a COC applies to causes of action arising after

the COC’s issuance, even if the lawsuit is filed prior to the COC’s issuance. The

Federal Circuit explained its holding as motivated, in part, by the court’s desire to

avoid the “illogical and unworkable result” that a patent holder might be able “to sue

an alleged infringer for activities that occurred before the issuance of the certificate

of correction” where the patent appeared invalid prior to the issuance of the COC but

was rendered valid as a result of the COC. In such a case, the Federal Circuit opined

that, prior to the issuance of the certificate, “reasonable competitors would be

justified” in competing with the invention. See id. at 1295 - 1296. 

This portion of the Federal Circuit’s discussion is dispositive because the

Federal Circuit’s “illogical and unworkable result” would not be avoided if a COC

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46

applied to lawsuits filed after the issuance of a COC where the lawsuit sought to

recover on causes of action accruing prior to the issuance of the COC. The only

interpretation that avoids the result decried by the Federal Circuit is the interpretation

that a COC applies only to causes of action arising after the issuance of the COC,

regardless of when the lawsuit seeking to recover on those causes of action is filed.

Also supporting this interpretation of the Southwest Software opinion is the

Federal Circuit’s following caveat: “Finally, we point out that, for any cause of action

arising after April 1, 1997, the date the certificate of correction issued, the certificate

will be treated as part of the original patent. Therefore, any invalidity arising from

the absence of the Program Printout Appendix only affects causes of action arising

before the certificate issued. Put another way, if claim 1 is found to have been invalid

without the Program Printout Appendix, the invalidity ceased on April 1, 1997, when

the PTO issued the certificate of correction.” Id. at 1297. This caveat simply is

incompatible with the defendants’ interpretation that a COC applies only to lawsuits

filed after its issuance. Were the defendants’ interpretation correct, the caveat would

have no application since the lawsuit in Southwest Software obviously had

commenced prior to the COC’s issuance. The only interpretation that gives this

dictum meaning is that the Federal Circuit was advising the district court that the

plaintiff could proceed on any claims arising after the COC’s issuance.

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47

Honoring that instruction, this court will permit the plaintiffs here to do the

same. For any causes of action for infringement of the ‘515 patent accruing after the

issuance of the certificate of correction, the COCshall apply, provided, of course, that

the certificate ultimately is held valid. For causes of action accruing prior to the

issuance of the COC, the COC shall have no application.

C. Facts

In support of the claims of infringement, the plaintiffs present evidence from

two experts. The first expert is Dr. Stanley B. Digerness. Dr. Digerness tested

fourteen samples of the defendants’ products that defendants provided during

discovery. The defendants admit that they commercially produce solutions 1-12. 

Dr. Digerness obtained blood samples from the cardiopulmonary bypass

reservoir of five randomly selected patients. Dr. Holman provided an additional

sample. After diluting each of the defendants’ 14 sample crystalloid solutions with

the collection blood samples, Dr. Digerness measured the calcium ion concentrations,

metabolizable substrate concentration, osmolality, and pH of each sample.

Dr. Digerness found that, when mixed 1 to 4 with blood, all fourteen of the

defendants’ samples had calcium concentrations ranging from 90-199 umol; glucose

concentrations ranging from 639-934 mg%; and amino acid concentrations ranging

from 24.2 to 26.5 mmol/L, in an even proportion between glutamate and aspartate.

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 47 of 67
48

Dr. Digerness also found that samples 1, 7, 9, 11, 12, 13, and 14 had a pH ranging

from 7.353 to 7.603. 

Dr. Digerness found that samples 1, 7, 9, 11, 12, 13, and 14 had osmolalities

ranging from 368 to 442 mOsmol/kg, with twenty-two of the forty-six data points at

385 mOsmol/kg or greater. Sample 1 had osmolalities of 385, 391, and 398 when

mixed with blood from patients 3, 1, and 2, respectively; and 394 when mixed with

Dr. Holman’s blood sample. Sample 7 had an osmolality of 385 and 393 when mixed

with blood from patients 3 and 2, respectively. Sample 9 had an osmolality of 389

and 390 when mixed with blood from patients 2 and 4, respectively. Samples 11 and

12 had osmolalities of 392 when mixed with blood from patient 2. Sample 13 had an

osmolality of 388 when mixed with blood from patient 2. Sample 14 had an

osmolality of 386 when mixed with blood from patient 2. When mixed with the

blood of the other patients, however, these samples had osmolalities of less than 385.

Furthermore, Dr. Digerness found that samples 2, 3, 4, 5, 6, 8, and 10 had

osmolalities of less than 385 mOsmol/kg. 

The plaintiffs’ second expert is Dr. Hal Peterson. Dr. Peterson did not test

solutions prepared by ACS. Instead, Dr. Peterson tested two solutions prepared by

the plaintiff CAPS (CS-1 and CS-2) that Dr. Peterson attests is “chemically identical”

to solutions sold by ACS to the University Hospital of New Orleans and Riverview

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 48 of 67
49

Hospital. Dr. Peterson found that, when mixed with human blood in a 1:4 ratio, these

samples, CS-1 and CS-2, had osmolalities ranging from 392 to 443 mOsmol/kg. Dr.

Peterson attests that CS-1 and CS-2 are “chemically identical” to defendants’ sample

solutions 11 and 12. 

The defendants present evidence from their expert, Dr. David R. Wade. Using

the test results produced by Dr. Digerness, Dr. Wade calculated the osmolarity of the

14 cardioplegic solutions tested by the plaintiffs’ experts. Dr. Wade calculated that

each of the fourteen solutions had osmolarities of between 349 and 377 mOsmol/L.

D. Infringement Prior to the Issuance of the COC

Prior to the issuance of the COC on January 30, 2001, the ‘515 patent covered

cardioplegic solutions with osmolarities of about 400-500 mOsmol/L. The court has

interpreted the claim of between about 400-500 mOsmol/L to apply to all solutions

having osmolarities within the range of 385-515 mOsmol/L. The testimony of Dr.

Wade is undisputed that none of the defendants’ 14 tested solutions came within the

claims range of 385-515 mOsmol/L. Osmolarity is a necessary element of the ‘515

patent under all three of its independent claims. Consequently, there is no evidence

of direct infringement of the patent as it read prior to the issuance of the COC.

The plaintiffs argue that questions of fact exist regarding whether the

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 49 of 67
Prosecution history estoppel can be amendment-based or it can be argument-based. See 19

Abbott Labs. v. Dey, L.P., 287 F.3d 1097, 1103 (Fed. Cir. 2002). Here, all of defendants’

prosecution history estoppel arguments are amendment-based.

50

defendants nevertheless are liable for infringement under the doctrine of equivalents.

Under the doctrine of equivalents, “a product or process that does not literally

infringe upon the express terms of a patent claims may nonetheless be found to

infringe if there is ‘equivalence’ between the elements of the accused patented

invention.” Warner Jenkinson Co., Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 21

(1997). 

The defendants argue that plaintiffs are barred from invoking the doctrine of

equivalents due to prosecution history estoppel. It is true that prosecution history

estoppel, if applicable, would prevent the plaintiffs from taking advantage of the

doctrine of equivalents. However, there is no question that amendment-based 19

prosecution history estoppel requires, at minimum, that the patentee have made a

narrowing amendment to his or her claims during the patent review process. See

Abbott Labs. v. Dey, L.P., 287 F.3d at 1103 (“[T]here can be no amendment-based

estoppel with respect to this claim limitation [that was not amended during the

prosecution of the patent].”). Rather, the only amendment that the defendants can

point to is the addition of the language “at an increased level” in claims 1 through 6.

Thus, the defendants can make no argument that the doctrine of equivalents does not

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 50 of 67
 The defendants, in their briefs, argue for amendment-based estoppel only. That is, they 20

do not argue that argument-based prosecution history estoppel applies. See, doc. 235 at pp. 26-

23. 

51

apply to claims 7 through 17 . 

20

In addition, the language that the defendants rely upon in no way limits the

scope of claims 1 through 6. The defendants argue that the language “at an increased

level” means that the doctrine of equivalents can only be applied to levels higher than

the patent’s claimed ranges of 400-500 mOsmol, but may not be applied to anything

below that range. The court ascribes no such meaning to this phrase. Instead, the

court interprets “at an increased level” to indicate merely that the cardioplegic

solution must be hyperosmolar as compared to the normal osmolarities found in

human blood. As human blood normally has an osmolarity of between 280 and 300

mOsmol, the ‘515 patent’s requirement that the solution be hyperosmolar cannot be

interpreted to limit the patent only to ranges above 400 mOsmol. 

Indeed, the court rejected this very argument by the defendants during the

claim construction phase of this action. At that time, the defendants argued that the

language “at an increased level” required the court to limit the claimed range of

between about 400 to 500 mOsmol as covering only ranges above, but nothing below,

400 mOsmol. The court rejected that argument and ruled that the patent’s claim of

“about 400-500 mOsmol” included “numbers both below and above the ranges

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52

specified in the ‘515 patent.” (Markmen Order, dated Sept. 4, 2003.) Accordingly,

prosecution history estoppel is not applicable here, and the plaintiffs are not barred

from arguing for the application of the doctrine of equivalents.

The essential inquiry under the doctrine is, “Does the accused or process

contain elements identical or equivalent to each claimed element of the patented

invention?” Warner Jenkinson Co., 520 U.S. at 40. This analysis may be determined

under the “triple identity” test–which focuses on the “function served by a particular

claim element, the way that element serves that function, and the result thus obtained

by that element–or it may be evaluated by inquiring whether the allegedly infringing

device or process possess only ‘insubstantial differences.’” Id. (emphases added).

In Warner Jenkinson Co., the Supreme Court observed that the triple identity test is

better suited for mechanical devices than for other products or processes. Thus, the

more suitable framework here is to inquire whether the defendants’ products contain

only “insubstantial differences” from the plaintiffs’ products. Under either

framework, “[t]he determination of equivalence should be applied as an objective

inquiry on an element-by-element basis.” Id. “[E]quivalency must be determined

against the context of the patent, the prior art, and the particular circumstances of the

case.” Graver Tank & Mfg. Co. v. Linde Air Prods. Co. (Graver II), 339 U.S. 605,

609 (1950).

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53

“A finding of equivalence is a determination of fact.” Graver Tanks & Mfg.

Co. v. Linde Air Prods. Co., 339 U.S. 65, 609 (1950). “[E]quivalency must be

determined against the context of the patent, the prior art, and the particular

circumstances of the case.” Johnson & Johnson Assocs. Inc. v. R.E. Serv. Co. Inc.,

285 F.3d 1046, 1053 (Fed. Cir. 2002). 

The facts before the Supreme Court in Warner Jenkinson Co. are similar to

those here. There, the patent at issue covered an ultrafiltration process that operated

at a “pH from approximately 6.0 to 9.0.” See Warner Jenkinson Co., 520 U.S. at 22.

The alleged infringer used an ultrafiltration process having a pH of 5.0. Id. The

Supreme Court held in that case that, as long as prosecution history estoppel did not

apply, the doctrine of equivalents could be applied. Based upon this holding and the

Supreme Court’s view that a jury reasonably could find a pH of 5.0 equivalent to a

pH of 6.0-9.0, the court sees no reason why an osmolarity of between 349 and 377

mOsmol/L might not be considered equivalent to an osmolarity of between 385 and

515 mOsmol/L. 

Furthermore, although the Supreme Court ruled that intent is irrelevant to the

application of the doctrine of equivalents, the plaintiffs have submitted evidence that

the defendants developed their solutions by copying the plaintiffs’ solutions precisely

except that they lowered the osmolarity of the solutions to just under the ranges

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54

claimed by the ‘515 patent. (See Memo of Charles Wall, dated June 2, 1998, Pla. Ex.

L; Letter by Robert Veal, dated Aug. 14, 1998, Pla. Ex. G.) This evidence is

sufficient to invoke the doctrine of equivalents, which is designed to ensnare exactly

“the unscrupulous copyist [who] make[s] unimportant and insubstantial changes and

substitutions in the patent which, though adding nothing, would be enough to take the

copied matter outside the claim, and hence outside the reach of law.” Graver Tanks

& Mfg., 339 U.S. at 605. If a jury determined that, as a factual matter, an osmolarity

of 349-377 mOsmol/L constitutes an insubstantial difference from an osmolarity of

385-515 mOsmol/L, the jury reasonably could find that the defendants infringed the

‘515 patent as it read prior to the issuance of the COC.

In response, the defendants have submitted the statements of Charles Wall, who

asserts that Buckberg misread the prior art by failing to appreciate that the optimal

osmolarity for cardioplegia is significantly below the ‘515 patent’s claimed ranges of

400-500 mOsmol/L. (See Wall Decl. ¶ 9.) Based upon this assertion, Wall claims

that the alterations of his solutions are not equivalents but instead constitute

substantial improvements on the cardioplegia. (Id.)

This conflicting evidence creates a question of fact to be resolved at trial.

Therefore, because prosecution history estoppel cannot apply in this case, the

plaintiffs may proceed on their infringement claims based upon the ‘515 patent as it

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Because summary judgment as to infringement is denied, it necessarily follows that the 21

plaintiffs’ motion for summary judgment as to whether the infringement was willful also is

DENIED. 

55

read prior to the issuance of the COC. Even though the defendants’ solutions did not

literally infringe the ‘515 patent prior to the issuance of the COC, the plaintiffs may

adduce proof that the osmolarity of the defendants’ solutions of between 349 to 377

mOsmol/L is equivalent to the claimed range of between 385 and 515 mOsmol/L.

Accordingly, the defendants’ motion for summary judgment on the plaintiffs’ claims

of infringement of the patent as it read prior to the issuance of the COC are due to be,

and hereby are, DENIED.21

E. Infringement Following the Issuance of the COC

The plaintiffs have moved for summary judgment on their claims of

infringement of the ‘515 patent as amended by the COC. The tests performed by Drs.

Holman and Digerness indicate that the defendants’ solutions 1, 7, 9, 11, 12, 13, and

14 come within the claimed ranges of the patent as to every element. 

Plaintiffs’ evidence shows that solutions 1, 7, 9, 11, 13, and 14 had a calcium

concentration between 90-199 umol. This is within the ‘515 patent’s claimed range

of 50-300 umol, and the defendants have presented no evidence to the contrary.

Plaintiffs’ evidence shows that solutions 1, 7, 9, 11, 13, and 14 had a glucose

concentration of between 639 and 934 mg%. This is within the ‘515 patent’s claimed

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56

range of 400-1000 mg%, and the defendants have presented no evidence to the

contrary. Plaintiffs’ evidence shows that solutions 1, 7, 9, 11, 13, and 14 had an

amino acid concentration of between 24.2 and 26.5 mmol/L in even proportions of

glutamate and aspartate. This is within the ‘515 patent’s claimed range 10-30

mmol/L of aspartate and between 10-30 mmol/L of glutamate, and the defendants

have presented no evidence to the contrary. Plaintiffs’ evidence shows that solutions

1, 7, 9, 11, 13, and 14 had a pH of between 7.353 and 7.603. This comes within the

claimed pH range of 7.5 and 7.7 pH, and the defendants have presented no evidence

to the contrary. Plaintiffs’ evidence shows that solutions 1, 7, 9, 11, 13, and 14 had

an osmolality of between 385 and 398 mOsmol/kg. This is within the ‘515 patent’s

claimed range 385 to 515 mOsmol/kg, and the defendants have presented no evidence

to the contrary. 

Thus, the undisputed evidence shows that the defendants directly infringe the

‘515 patent as to claims 13 through 17. As to these claims, the defendants’

infringement is direct because the defendants manufacture and sell crystalloid

cardioplegic solutions which are adapted to be diluted with blood at a 1 to 4 ratio.

(See ‘515 patent claims 13-17; Holman Decl. at ¶ 2.) With respect to claims 1

through 12 and 18, the defendants’ infringement is contributory because they sell

their cardioplegia products with the intent that the customers will mix them with

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To be contributorily liable for infringement, it must be shown that (1) the defendants 22

sold solutions comprising a material part of the patented invention; (2) the defendants knew the

solutions sold were especially made for use in practicing the patented invention; and (3) the

solutions sold were not a staple article or commodity of commerce suitable for substantial

noninfringing use. See 35 U.S.C.A. § 271(c). Here, the memorandum written by Charles Wall,

dated June 2, 1998 (Pla. Ex. L), shows that the defendants intended their customers to mix

ACS’s solutions with blood at a 1 to 4 ratio, which would produce cardioplegic solutions used

for the treatment of human hearts within the claimed ranges of the ‘515 patent.

57

blood at a 1 to 4 ratio, thereby bringing the solution within the scope of ‘515 patent’s

claims.22

The undisputed evidence shows, therefore, that the defendants are liable for

direct and contributory infringement of the ‘515 patent as amended by the COC.

However, because the court already has ruled that the defendants may present

evidence at trial challenging the validity of the COC, the court cannot grant summary

judgment on infringement at this time. Instead, the Court will grant summary

judgment to the plaintiffs only in part and deny it in part. The plaintiffs’ motion for

summary judgment is GRANTED IN PART as to the issue of whether the

defendants are liable for infringement of the ‘515 patent as amended by the COC,

provided that the COC is valid. The motion is DENIED IN PART insofar as the

validity of the COC is a question of fact to be determined at trial. 

Similarly, the court will grant in part and deny in part the plaintiffs’ motion for

summary judgment on their claim that the defendants willfully infringed the ‘515

patent. The plaintiffs claim that the defendants’ infringement of the patent was

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In his opinion letter, Veal advised the defendants to keep the ranges of the constituent 23

elements of their solutions “significantly out of the specified ranges” of the ‘515 patent. Veal

opined that an osmolarity of 360 mOsmol/L would qualify as significantly outside of the ‘515

patent’s claimed range. The plaintiffs argue that the defendants failed to adhere to Veal’s advice

because the undisputed evidence here indicates that the defendants’ products contained

osmolarities of as high as 377 mOsmol/L. Because the court denied summary judgment on the

plaintiffs’ claims of infringement prior to the issuance of the COC, the court does not need to

resolve at this time whether Veal’s letter constitutes a defense to willful infringement of the ‘515

patent prior to the issuance of the COC.

58

willful and seek to recover the treble damages authorized by statute for willful

infringement. See 35 U.S.C.A. § 284.

The undisputed evidence indicates that the defendants directly copied the

plaintiffs’ patented solutions in developing their products. (Wall Dep. at 29-30, 48;

Memo of Charles Wall, dated June 2, 1998.) This is strong evidence of willful

infringement. See Stryker Corp. v. Intermedics Orthopedics, Inc., 96 F.3d 1409, 1414

(Fed. Cir. 1996). The only evidence rebutting a finding of willfulness is the opinion

letter that the defendants obtained from their counsel, Robert Veal. Ordinarily, an

opinion letter from counsel will insulate an infringer from a charge of willful

infringement if the opinion of counsel is both favorable and competent. See Johns

Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1363 (Fed. Cir. 1998). 

Here, however, defendants’ counsel, Robert Veal, advised the defendants only

as to the ‘515 patent as it read prior to the issuance of the COC. The defendants 23

have submitted no evidence that they obtained a competent opinion fromcounsel that

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 58 of 67
59

would insulate them from liability for infringement of the corrected patent.

Accordingly, there is no dispute of fact as to the willfulness of the defendants’

infringement of the ‘515 patent following the issuance of the COC. The court

therefore will, and hereby does, GRANT IN PART summary judgment as to the

willfulness of the defendants’ infringement of the ‘515 patent following the issuance

of the COC, provided that at trial the COC is found to be valid. The plaintiffs’

motion for summary judgment on its claim that the defendants’ infringement of the

patent was willful is in all other respects DENIED.

VI.

Counterclaims

The plaintiffs move for summary judgment on the defendants’ counterclaims

of (1) false marking under the False Marking Statute, 35 U.S.C. § 292(a) (“Section

292") and (2) false advertising under the Lanham Act, 15 U.S.C. § 1125 (a)(1)(B).

Each motion is addressed in turn.

A. Facts

In support of the counterclaims of false marking and false advertising, the

defendants offer expert reports from Dr. Stanley B. Digerness and Dr. Hal Peterson.

These expert reports are discussed at length supra. The defendants rely specifically

on the results in each report for the osmolalities of samples of the Buckberg Solution

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 59 of 67
In the Markman Order dated May 2, 2002, the court ruled that an osmolality of 24

“between about 400-500 mOsmol” encompasses osmolalities “from 385-515.” 

The Eleventh Circuit, in Bonner v. City of Prichard, 661 F.2d 1206, 1207 (11 Cir. 25 th

1981) (en banc), adopted as precedent decisions of the former Fifth Circuit rendered prior to

October 1, 1981.

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tested. As described above, the Buckberg Solution consists of an amino acid enriched

cardioplegic solution having (1) a calcium ion concentration of between 50-300 umol;

(2) a concentration of metabolizable substrate between about 400-1000 mg%; and (3)

an osmolality of between about 400-500 mOsmol. It is not disputed that the 24

plaintiffs mark all amino enriched cardioplegic solutions as being covered by the ‘515

patent. 

B. False Marking

Count II of the defendants’ counterclaim alleges false marking under Section

292. Section 292 is a private attorney general statute that allows recovery of penal

damages against anyone who fraudulently misrepresents that a product is subject to

a patent. The damages awarded under Section 292 are shared equally with the

government. See 35 U.S.C. § 292(b).

The threshold for establishing a successful Section 292 claim is extremely high.

Brose v. Sears, Roebuck, & Co., 455 F.2d 763, 768 (5 Cir. 1972). Both the th 25

language of Section 292 and the binding authority in this Circuit place on the

defendantsthe burden to plead and produce facts demonstrating that the plaintiffs, in

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marking the solution with the ‘515 patent, had the specific intent to deceive the public

into believing something that the plaintiffs knew to be false. Id. See also Clontech

Laboratories, Inc. v. Invitrogen Corp., 406 F.3d 1347, 1355 (Fed. Cir. 2005) (intent

is a key element under a Section 292 claim); Arcadia Machine & Tool, Inc. v. Sturm,

786 F.2d 1124, 1125 (Fed. Cir. 1986) (mismarking must have been done for the

purpose of deceiving the public); Mayview Corp. v. Rodstein, 620 F.2d 1347, 1359

(9 Cir. 1980) (same). In order to demonstrate an intent to deceive, the defendants th

must show by a preponderance of the evidence that the plaintiffs “did not have an

honest good faith belief in marking its products.” Clontech Laboratories, Inc. v.

Invitrogen Corp., 406 F.3d 1347, 1355 (Fed. Cir. 2005) (citing Brose v. Sears,

Roebuck, & Co., 455 F.2d 763, 768-769 (5 Cir. 1972)). th

The sole issue for this court to consider in analyzing the counterclaim for false

marking is whether or not the defendants have established, through a preponderance

of the evidence, that the plaintiffs manifested the intent to deceive when marking the

cardioplegic solutions that tested outside the acceptable osmolality range for the ‘515

patent. Because the court finds that the defendants fail to meet its burden of offering

evidence that demonstrates an intent to deceive on the part of the plaintiffs, the

Section 292 claim fails.

The Eleventh Circuit has “adopted the formulation that an honest, though

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Claims brought under Section 292 as part of a strategic plan in pending patent litigation 26

are not favored. See Brose v. Sears, Roebuck and Co., 455 F.2d 763, 768 (5 Cir. 1972) (“It is at th

this point that the law-perhaps out of distaste for blood money suits-compels a positive showing.

For here not only are objective physical facts involved. Here are questions of motive, purpose

and attitudes.”).

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mistaken, mismarking of an article would not trigger liability under [Section 292].”

Clontech Laboratories, Inc. v. Invitrogen Corp., 406 F.3d 1347, 1352 (Fed. Cir.

2005) (citing Brose v. Sears, Roebuck and Co., 455 F.2d 763, 768-769 (5 Cir. th

1972)). Section 292 is not a statute of strict liability for mismarking. Id. “Intent to

deceive is a state of mind arising when a party acts with sufficient knowledge that

what it is saying is not so and consequently that the recipient of its saying will be

misled into thinking that the statement is true.” Clontech 406 F.3d 1347 at 1352

(citing Seven Cases v. United States, 239 U.S. 510, 517-517, 36 S.Ct. 190, 60 L.Ed.

411 (1916)).

Intent to deceive is proved when (1) the patent does not cover the marked

article; and (2) the differences between the mismarked article and a properly marked

article are “so plain that no one in good faith” could think otherwise. Brose v. 26

Sears, Roebuck and Co., 455 F.2d 763, 768 (5 Cir. 1972). th

We can assume that if a device claimed to be covered by license of a

cited patent is so obviously not revealed by it as the patentese world

would view it, the use of such a legend would be mismarking. But

where the device is within the specific field covered by the patent and

uses materials and methods similar to the technical patent disclosures,

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63

the licensee's use in good faith reliance on the license is not to be

transmuted into an evil purpose to deceive the public merely on proof

and finding that for one or more or all of the reasons skilled patent

advocates could think up, the embodiment in question does “not read

on” or is not an “infringement” of the cited patent. But this presupposes

that the private attorney general has established that the device is not

within the patent. Only at that time does the good faith purpose or

motive of the marker of a license to a cited patent come into question.

Id. at 768-769. The defendants fail to meet their burden of proof under the first

element of the intent test in Brose; therefore the court need not consider the merits of

the present case under the second element of the test.

It is undisputed that the plaintiffs mark all their amino enriched cardioplegic

solutions with the ‘515 patent and that the acceptable osmolality range covered under

the patent is between 385-515 mOsmol.

The defendants claim that they need not test the plaintiffs’ marked solutions to

determine that the solutions fall outside the range of the ‘515 patent because the

plaintiffs’ own tests demonstrate that fact. See Defendants’ Memorandum in

Opposition to Plaintiffs’ MSJ No. 3 False Marking and False Advertising at 16. The

defendants do not challenge that the Buckberg Solution marked by the plaintiffs

contains a calcium ion concentration of between 50-300 umol and a concentration of

metabolizable substrate between 400-1000 mg% as is required under the patent;

rather, the defendants solely posit that certain marked containers of solution fall

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As previously discussed, the court’s Markman Order dated May 2, 2002, held that 27

claims involving the ‘515 patent must be analyzed using the term “osmolality” and not

“osmolarity.” 

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outside the ‘515 patent osmolality range of “about 400-500 mOsmol.” An

examination of the evidence is contrary to the defendants’ position. None of the

plaintiffs’ tests show an osmolality range of the plaintiffs’ amino enriched

cardioplegic solution outside the patent range of “about 400-500 mOsmol.”

The bulk of the defendants’ argument and evidence that the plaintiffs’ marked

solutions fall outside of the ‘515 patent concern the osmolarity of the plaintiffs’

marked solution. As arguments related to the osmolarity of the plaintiffs’ solution

have been expressly rejected by this court they will not be considered.27

The defendants have not satisfied their burden under the first element of the

test in Brose. In addition, the court notes that the defendants’ counterclaim fails

under the second element of a Brose analysis. The differences between a mismarked

solution falling outside of the osmolality range of the ‘515 patent and a properly

marked solution are so negligible that no one in good faith could find that the plain

differences between the two solutions reveal an intent to deceive on the part of the

plaintiffs. A variation in the osmolality range of a marked solution coupled with the

lack of evidence establishing that the plaintiffs’ marked solution does not contain a

calcium ion concentration of between 50-300 umol or that the marked solution does

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 64 of 67
65

not contain a concentration of metabolizable substrate between 400-1000 mg% as is

required under the patent leads the court to hold that, even if there is a variation in the

osmolality range of the marked solution outside of the ‘515 patent parameters, such

a variation does not rise to the level of an intent to deceive under the second element

of the test in Brose. Accordingly, the plaintiffs’ motion forsummary judgment on the

defendants’ claim of false marking is due to be, and hereby is, GRANTED.

C. False Advertising

Count III of the defendants’ counterclaim alleges that the plaintiffs’ marking

of its amino acid enriched solutions with the ‘515 patent comprises false advertising

actionable under the Lanham Act.

“It is well-settled that no proof of intent or willfulness is required to establish

a violation of the Lanham Act ... for false advertising.” Vector Products, Inc. v.

Hartford Fire Ins. Co., 397 F.3d 1316, 1319 (11 Cir. 2005). To succeed on a false th

advertising claim under the Lanham Act, a defendant must show that: (1) the plaintiff

made false or misleading statements about its product in an advertisement; (2) the

advertisement actually deceived, or had the tendency to deceive, the targeted

audience; (3) the deception is material; (4) the plaintiffs’ advertised product traveled

in interstate commerce; and (5) the defendant has been or is likely to be injured as a

result of the false or misleading advertisements.” See Hyman v. Nationwide Mut. Fire

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The plaintiffs and defendants reference the court to Zenith Elect. Corp. v. Exzec, Inc.,

28

182 F.3d 1340, 1348 (Fed. Cir. 1999), in order to add an additional element for analysis to the

defendants’ Lanham Act claim for false advertising that the plaintiffs’ alleged marketplace

66

Ins. Co., 304 F.3d 1179, 1196 (11 Cir. 2002). The failure of the defendants to th

satisfy their burden with respect to any one of the foregoing elements warrants

summary judgment in favor of the plaintiffs. See Laughlin Products, Inc. v. ETS,

Inc., 257 F. Supp. 2d 863 (N.D. Tex. 2002) (the plaintiffs need “only show that

[defendants] who bear the burden to prove, have adduced no evidence to support an

essential element of the case.”). 

The defendants have not offered any facts and this court cannot locate any

evidence in the record showing that: (1) the plaintiffs marked its amino enriched

cardioplegic solutions as being patented; (2) the marking of the plaintiffs’ solutions

actually deceived or had the tendency to deceive the public; or (3) that any alleged

deceptive marking would be material in that the marking somehow influenced

customers’ purchasing decisions. The parties concede that the marked solutions are

sold and transported as a part of interstate commerce. Because the first three

elements of the test articulated in Hyman are not satisfied, the court will not provide

analysis under the moot fifth element as to whether or not the defendants have

suffered an injury as a result of hypothetical false advertising on the part of the

plaintiffs. Accordingly, the plaintiffs’ motion for summary judgment on the 28

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activity in support of the ‘515 patent “must have been undertaken in bad faith.” As neither party

cited to Eleventh Circuit or U.S. Supreme Court precedent on this issue and the court, through its

own examination, has not located a binding decision relating to the element of “bad faith”

discussed in Zenith, the court is unwilling to venture beyond the Lanham Act precedent of this

Circuit.

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defendants’ claim of false advertising under the Lanham Act is due to be, and hereby

is, GRANTED.

This opinion shall be carried out by a separate Order. 

DONE and ORDERED this 10th day of January, 2006.

 

 VIRGINIA EMERSON HOPKINS

United States District Judge

Case 2:00-cv-02430-VEH Document 268 Filed 01/10/06 Page 67 of 67