Therasense, Inc. v. Beckton, Dickinson and Co.

• Court: Court of Appeals for the Federal Circuit
• Decided: January 25, 2010
• Docket: 08-1511
• Status: Published

Opinion

United States Court of Appeals for the Federal Circuit 2008-1511, -1512, -1513, -1514, -1595

THERASENSE, INC. (now known as Abbott Diabetes Care, Inc.) and ABBOTT LABORATORIES,

Plaintiffs-Appellants,

v.

BECTON, DICKINSON AND COMPANY, and NOVA BIOMEDICAL CORPORATION,

Defendants-Appellees,

and

BAYER HEALTHCARE LLC,

Defendant-Appellee.

Rohit K. Singla, Munger, Tolles & Olson LLP, of San Francisco, California, argued for plaintiffs-appellants. With him on the brief were Jason A. Rantanen; and Donald W. Ward, of Los Angeles, California.

Bradford J. Badke, Ropes & Gray LLP, of New York, New York, argued for defendants-appellees Becton, Dickinson and Company, et al. Of counsel were Gabrielle M. Ciuffreda and Sona De.

Rachel Krevans, Morrison & Foerster LLP, of San Francisco, California, argued for defendant-appellee Bayer HealthCare LLC. With her on the brief were Jason R. Bartlett and Parisa Jorjani; and Kenneth P. George and Joseph M. Casino, Amster Rothstein & Ebenstein LLP, of New York, New York. Of counsel was Wesley E. Overson, Morrison & Foerster LLP, of San Francisco, California.

Appealed from: United States District Court for the Northern District of California

Judge William H. Alsup United States Court of Appeals for the Federal Circuit

2008-1511, -1512, -1513, -1514, -1595

THERASENSE, INC. (now known as Abbott Diabetes Care, Inc.) and ABBOTT LABORATORIES,

BECTON, DICKINSON AND COMPANY, and NOVA BIOMEDICAL CORPORATION,

Appeals from the United States District Court for the Northern District of California in consolidated case nos. 04-CV-2123, 04-CV-3327, 04-CV-3732, and 05-CV-3117, Judge William H. Alsup.

___________________________

DECIDED: January 25, 2010 ___________________________

Before LINN, FRIEDMAN, and DYK, Circuit Judges.

Opinion for the court filed by Circuit Judge DYK. Opinion concurring-in-part and dissenting-in-part filed by Circuit Judge LINN.

DYK, Circuit Judge.

Therasense, Inc. (now Abbott Diabetes Care, Inc.) and Abbott Laboratories

appeal from a final judgment of the United States District Court for the Northern District of California. Following a bench trial, the district court determined that claims 1–4 of

U.S. Patent No. 5,820,551 (“the ’551 patent”) were invalid due to obviousness and that

the entire ’551 patent was unenforceable due to inequitable conduct. See Therasense,

Inc. v. Becton, Dickinson & Co., 565 F. Supp. 2d 1088 (N.D. Cal. 2008) (“Trial Opinion”).

The district court also granted summary judgment of noninfringement of all asserted

claims in U.S. Patent Nos. 6,143,164 (“the ’164 patent”) and 6,592,745 (“the ’745

patent”). See Therasense, Inc. v. Becton, Dickinson & Co., 560 F. Supp. 2d 835 (N.D.

Cal. 2008) (“Summary Judgment Order”). Finally, it found nearly all of the asserted

claims of the ’745 patent invalid due to anticipation. Id. We affirm.

BACKGROUND

I

The Centers for Disease Control and Prevention estimates that 23.6 million

Americans have diabetes. Ctrs. for Disease Control & Prevention, National Diabetes

Fact Sheet, 2007, at 5 (2008). Diabetes mellitus, generally referred to simply as

diabetes, is a disorder of the carbohydrate metabolism in which the body either does not

produce enough or does not properly utilize insulin, a hormone produced in the

pancreas. Insulin regulates blood sugar levels by facilitating the absorption of glucose

into cells. In diabetics, this failure of the body to produce or utilize insulin causes

glucose to build up in the blood, leading to potentially serious complications, such as

comas, blindness, kidney damage, cardiovascular disease, and lower-limb amputations.

Diabetics today rely on inexpensive and accurate home blood glucose meters to help

them manage their condition.

2008-1511, -1512, -1513, -1514, -1595 2 The patents-in-suit claim technology in the area of disposable blood glucose test

strips. These single-use strips work in conjunction with glucose meters and employ

electrochemical biosensors to measure the level of glucose in a sample of blood,

usually a single drop. When blood is introduced to a test strip, the glucose in the blood

reacts with an enzyme present on the strip, transferring electrons to the enzyme. A

mediator, also incorporated on the strip, transfers the electrons from the enzyme to the

sensor’s “active electrode.” The electrons then flow from the strip into the meter, which

calculates the glucose concentration based on the current flow. While common test

strips measure glucose levels in samples of whole blood (blood that contains all of its

components, including red blood cells), electrochemical sensors are also capable of

measuring glucose levels in a variety of other sample types, such as blood plasma

(blood without red blood cells), interstitial fluid (fluid between cells in the skin and

organs), and buffer solutions (test solutions that simulate blood). They are also capable

of measuring samples in vivo—inside the body—such as live blood. We describe below

the various patents involved here.

II

Abbott Diabetes Care, Inc., the successor to Therasense, Inc. and a subsidiary of

Abbott Laboratories, is the owner of the patents-in-suit. For convenience we will use

the single designation “Abbott” to refer to any and all of the foregoing. In March 2004,

Becton, Dickinson and Co. (“BD”) sued Abbott in the United States District Court for the

District of Massachusetts seeking a declaratory judgment of noninfringement of the ’164

and ’745 patents. The two products involved were the BD Latitude Diabetes

Management System and the BD Logic Blood Glucose Monitor. Both products featured

2008-1511, -1512, -1513, -1514, -1595 3 BD’s blood glucose test strip, the BD Test Strip. Two months later, Abbott countersued

BD in the Northern District of California alleging infringement of the ’164, ’745, and ’551

patents. The action in the District of Massachusetts was subsequently transferred to

the Northern District of California. Shortly thereafter, Abbott also initiated an

infringement action against Nova Biomedical Corp. (“Nova”), BD’s supplier, alleging

infringement of the ’164, ’745, and ’551 patents asserted in Abbott’s suit against BD. 1

In August 2005, Abbott sued Bayer Healthcare LLC (“Bayer”) alleging that its Microfill

and Autodisc blood glucose strips infringed the ’551 and ’745 patents.

All of the cases were consolidated, with the defendants asserting that their

products did not infringe Abbott’s patents and that the patents were invalid. On April 3,

2008, the court issued a summary judgment order finding that BD/Nova’s products did

not infringe any of the asserted claims of the ’164 or ’745 patents. It also found claims

1–5, 8, 21–23, 28, 31, and 34 in the ’745 patent anticipated. Summary Judgment

Order, 560 F. Supp. 2d at 880. Issues relating to the ’551 patent were considered in a

bench trial from May 27–June 3, 2008. After trial the district court determined that

claims 1–4 of the ’551 patent were invalid due to obviousness and that the entire ’551

patent was unenforceable due to inequitable conduct. Trial Opinion, 565 F. Supp. 2d at

1127. 2 The district court entered Rule 54(b) judgments, and we have jurisdiction over

this appeal pursuant to 28 U.S.C. § 1295(a)(1).

1 Because Abbott accuses BD and Nova of infringement based on the same BD products, BD and Nova will hereinafter be referred to collectively as “BD/Nova.” 2 Abbott also sued BD/Nova alleging that the BD Test Strip infringes U.S. Patent No. 5,628,890. That patent was the subject of a separate jury trial in which the jury found that the BD Test Strip did infringe the patent, but that the patent was invalid. After entry of judgment, Abbott appealed, and that judgment is the subject of a separate

2008-1511, -1512, -1513, -1514, -1595 4 DISCUSSION

I Obviousness of the ’551 Patent

We first address the district court’s holding that claims 1–4 of the ’551 patent

would have been obvious in light of U.S. Patent Nos. 4,545,382 (“the ’382 patent”) and

4,225,410 (“the ’410 patent”). Obviousness is a question of law based on underlying

questions of fact. Daiichi Sankyo Co., Ltd. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed.

Cir. 2007) (citing Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1348 (Fed. Cir.

2000)). We therefore review the ultimate determination of obviousness by a district

court de novo and the underlying factual inquiries for clear error. Id.

A Membraneless Sensor

The claims of the ’551 patent describe a test strip with an electrochemical sensor

for testing whole blood without any membrane over the electrode. 3 Some sensors in

appeal in Therasense, Inc. v. Becton, Dickinson & Co., Nos. 2009-1008, -1009, -1010, - 1034, -1035, -1036, -1037 (Fed. Cir. Jan. 25, 2010). 3 Claim 1 of the ’551 patent is representative. It provides:

1. A single use disposable electrode strip for attachment to the signal readout circuitry of a sensor to detect a current representative of the concentration of a compound in a drop of a whole blood sample comprising: a) an elongated support having a substantially flat, planar surface, adapted for releasable attachment to said readout circuitry; b) a first conductor extending along said surface and comprising a conductive element for connection to said readout circuitry; c) an active electrode on said strip in electrical contact with said first conductor and positioned to contact said whole blood sample; d) a second conductor extending along said surface comprising a conductive element for connection to said read out circuitry; and e) a reference counterelectrode in electrical contact with said second conductor and positioned to contact said whole blood sample, wherein said active electrode is configured to be exposed to said whole blood sample without an intervening membrane or other whole blood

2008-1511, -1512, -1513, -1514, -1595 5 the prior art had employed diffusion-limiting membranes to control the flow of glucose to

the electrode because the slower mediators of the time could not deal with a rapid

influx. Other prior art sensors employed protective membranes to prevent “fouling”—

when red blood cells stick to the active electrode and interfere with electron transfer to

the electrode, resulting in an inaccurate measurement. In addition, sensors injected into

the human body for in vivo measurements used protective membranes as a safety

measure to prevent the chemistry from dissolving into the body and because fouling

was a particular problem with respect to long-term in vivo implants.

The central question with respect to obviousness is whether the prior art

disclosed a glucose sensor without a membrane for use in whole blood. The district

court found after trial that the prior art ’382 patent disclosed electrochemical sensors in

which “a protective membrane was optional in all cases except the case of live blood, in

which case the protective membrane was preferred—but not required.” Trial Opinion,

565 F. Supp. 2d at 1103. Whether the ’382 patent disclosed a membraneless sensor is

filtering member and is formed by coating a portion of the first conductor with a mixture of or layers of an enzyme which catalyzes a redox reaction with said compound in whole blood and a mediator compound which transfers electrons from said redox reaction to said first conductor to create a current representative of the concentration of said compound in said whole blood sample; and wherein said active electrode which is formed on a portion of said conductor is not in electrical contact with said reference counterelectrode but these electrodes are so dimensioned and positioned that they can be simultaneously completely covered by a single drop of whole blood such that this drop provides an electrical path between these electrodes to support said current representative of the concentration of said compound in said whole blood sample.

’551 patent col.13 l.29–col.14 l.17 (emphasis added).

2008-1511, -1512, -1513, -1514, -1595 6 a question of fact which we review for clear error. See Graham v. John Deere Co., 383

U.S. 1, 17 (1966).

Initially filed in 1981 by one of Abbott’s predecessors, the ’382 patent

represented an early achievement in the field of electrochemical sensors for measuring

glucose levels. The ’382 patent disclosed a faster-acting ferrocene mediator chemistry

that allowed for better response times and quicker test results. The first two named

inventors on the ’382 patent are also the first two named on the ’551 patent.

At the outset, it is important to understand the scope and context of the ’382

patent. The claims of a prior art patent are part of its disclosure. In re Brenno, 768 F.2d

1340, 1346 (Fed. Cir. 1985) (“[I]t is true . . . that ‘a claim is part of the disclosure’ . . . .”);

In re Smolak, 88 F.2d 838, 841 (CCPA 1937) (“[T]he disclosures in [prior art]

specifications . . . include the claims, the written specification, and the drawings.”

(quotation omitted)); see also Gabrielidis v. Prince Sports Group, Inc., Nos. 99-1469,

99-1490, 2000 WL 1648134, at *7 (Fed. Cir. Nov. 1, 2000). The claims of the ’382

patent are plainly directed in part to sensors without a membrane, as is made clear by

the dependent claims that specifically include a membrane as an additional feature of

the device. For example, claim 1 claims a sensor electrode utilizing an enzyme and a

ferrocene mediator for generating an electrical current representative of the level of a

substance in a sample liquid, see ’382 patent col.10 ll.52–63, while dependent claim 12

adds “an outermost protective membrane permeable to water and glucose molecules,

said membrane covering said enzyme located upon said ferrocene layer,” id. col.11

ll.29–32. One embodiment described in the patent involves a membraneless sensor for

testing interstitial fluid, see id. col.3 l.53–col.4 l.2, and Example 8 of the patent

2008-1511, -1512, -1513, -1514, -1595 7 specifically describes tests on strips using a buffer solution both with and without

membranes, see id. col.9 ll.22–30.

Abbott appears not to contest that the ’382 patent broadly claims membraneless

strips and that the specification discloses such membraneless strips. It contends,

however, that in the case of blood—as opposed to other fluids—a membrane is

required. In this respect it is significant that none of the claims in the ’382 patent

explicitly distinguishes between blood and other fluids. Also pertinent is the difference

between in vivo sensors and in vitro sensors. In vivo sensors test live blood or other

fluids inside the body, while in vitro sensors test fluids such as blood after they have

been extracted from the body. Claims 1–17 of the ’382 patent cover both in vivo and in

vitro sensors; additional claims 18–19 are limited to in vivo sensors, though again those

claims do not distinguish between sensors for blood and other fluids.

Thus, as the district court found, the difficulty with Abbott’s position that

membranes are required for blood testing is that the claims covering membraneless

sensors do not exclude blood and that other fluids are described as being tested by

sensors without membranes. Most significantly, the specification addresses blood

directly, stating that:

Optionally, but preferably when being used on live blood, a protective membrane surrounds both the enzyme and the mediator layers, permeable to water and glucose molecules.

Id. col.4 ll.63–66. On its face, the specification appears to contradict Abbott’s position.

It states that when testing with blood—blood in the body (i.e., in vivo testing)—a

protective membrane is preferred. The use of the term “preferably” implies that such a

membrane is not necessary. See, e.g., Callaway Golf Co. v. Acushnet Co., 576 F.3d

2008-1511, -1512, -1513, -1514, -1595 8 1331, 1346–47 (Fed. Cir. 2009) (holding that despite stating that the outer layers of a

golf ball were “preferably” made of ionomer resins, the patent also disclosed the use of

other materials such as polyurethane); Halliburton Energy Servs., Inc. v. M-I LLC, 514

F.3d 1244, 1251 (Fed. Cir. 2008) (“[T]he specification states that ‘preferably’ none of

these clays are added; this strongly suggests that absence of clays is simply a preferred

embodiment.”); Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1357 (Fed. Cir.

2003) (“[U]se of the term ‘preferably’ makes clear that the language describes a

preferred embodiment, not the invention as a whole.”). Furthermore, when testing other

sample types—which include whole blood outside the body, as well as blood plasma,

interstitial fluid, and buffer solutions—the protective membrane is “optional,” even more

strongly confirming that it is not required for whole blood. The language of the patent

thus confirms that a membrane is not necessary when testing live blood in vivo or whole

blood in vitro.

Abbott, however, contends that a person having ordinary skill in the art would not

have read the ’382 specification that way. Abbott asserts that the conventional wisdom

of those skilled in the art was that a membrane was necessary when testing with blood,

and that skilled artisans would not have read the patent’s disclosure literally when it said

that a membrane was not necessary with blood.

Abbott may well be correct that for in vivo blood testing—where the sensor is

implanted in the body for up to a year—a membrane might sometimes be required for

safety and for accurate measurement because of the risk of fouling over the long period

2008-1511, -1512, -1513, -1514, -1595 9 of time that the sensor must operate. 4 The question, however, is whether a membrane

was required for in vitro testing of whole blood where the blood stays on the sensor for,

at most, a matter of minutes. Dr. Johnson, Abbott’s expert, testified that one of ordinary

skill in the art in 1983 would have thought that a membrane was required with blood

with the ’382 patent because of the risk of fouling. He did not specifically address the

differences between in vivo and in vitro testing of blood. Bayer’s expert witness, on the

other hand, specifically addressed both types of testing, recognizing that for in vivo

testing of blood a membrane might be necessary to ensure patient safety from the risk

of chemicals escaping the sensor and entering the body, and to eliminate the problem

of fouling that would occur as the sensor remained in the body for weeks or months. He

testified that with in vitro testing a membrane was not necessary because there was no

risk of chemicals entering the body and the time period involved in the testing was very

short, particularly with respect to the faster chemistry claimed in the ’382 patent. The

district court plainly found the Abbott testimony not credible and credited the Bayer

testimony, stating:

Skilled artisans would have known that deleting the membrane would simply have deleted their mechanical advantages. They would have known, however, that the electrochemistry would still have worked. They would have known that the degree of fouling would have depended on how long the sensor was exposed to blood. They would have known that the risk of fouling would have been reduced for faster-acting chemistry and reduced even more for sensors used only once, i.e., disposable sensors with no accumulation of residue. They would have known that omitting the filter would have had the further advantage of speeding up the test time even more.

4 However, one of the inventors of the ’382 and ’551 patents, Dr. Higgins, testified that even the phrase “preferably when being used on live blood” meant that “you would probably need a membrane, but not definitely.” J.A. 3104.

2008-1511, -1512, -1513, -1514, -1595 10 Trial Opinion, 565 F. Supp. 2d at 1101. The district court did not clearly err in crediting

Bayer’s expert testimony.

Abbott also contends that another portion of the ’382 patent’s specification

beyond the “[o]ptionally, but preferably” sentence demonstrates that a membrane is

required when testing whole blood. Abbott in particular points to Example 8 of the

patent. Abbott theorizes that the failure of Example 8 (listing test results for a buffer

solution with and without a membrane and blood with a membrane) to mention whole

blood testing without a membrane somehow demonstrates that whole blood testing

required a membrane. We reject this argument. A single example testing whole blood

with a membrane does not imply that membranes are required. In fact, there was

testimony from Dr. Turner that Example 8’s tests with the buffer solution demonstrated

that the membraneless sensor would have worked with blood and provided a

suggestion to do so, because the pH level of the buffer was apparently deliberately

chosen in this example to match the pH of blood. The district court correctly found that

“Example 8 in the ’382 patent [is] consistent with the plain meaning of [the ‘[o]ptionally,

but preferably’] sentence.” Trial Opinion, 565 F. Supp. 2d at 1100. The court thus did

not clearly err in finding that the ’382 patent disclosed a membraneless sensor for whole

blood testing. 5

5 Abbott also attempts to rely on U.S. Patent No. 4,897,173 (“the ’173 patent”) to show that the ’382 patent did not disclose a membraneless sensor for whole blood and that the conventional wisdom of those of ordinary skill in the art was that a membrane was necessary when testing whole blood even after the ’382 patent. The fact that the ’173 patent contained an example in which whole blood was tested using a sensor including a membrane hardly suggests that a membrane was universally required.

2008-1511, -1512, -1513, -1514, -1595 11 B Enablement and Reasonable Expectation of Success

In order to render a claimed apparatus or method obvious, the cited prior art as a

whole must enable one skilled in the art to make and use the apparatus or method.

Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989).

An individual prior art reference, on the other hand, “need not be enabled; it qualifies as

a prior art, regardless, for whatever is disclosed therein.” Amgen, Inc. v. Hoechst

Marion Roussel, Inc., 314 F.3d 1313, 1357 (Fed. Cir. 2003); see also Symbol Techs.,

Inc. v. Opticon, Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991); Beckman Instruments, 892

F.2d at 1551.

Abbott contends that the ’382 patent in combination with the ’410 patent could

not enable the membraneless sensor of the ’551 invention because the oxygen

sensitivity of the ’382 patent renders it ineffective when testing whole blood without a

membrane. Oxygen sensitivity is an indicator of the effect that an oxygen-rich sample

will have on the ability of a sensor to provide an accurate reading. Example 8 of the

’382 patent, for example, notes that tests measuring glucose levels in an oxygen-

saturated buffer solution returned a reading 95% of that produced in an oxygen-

depleted buffer. ’382 patent col.9 ll.19–21. The ’382 patent thus displayed a 5%

oxygen sensitivity. Both sides’ experts agreed that a 5% oxygen sensitivity is tolerable. 6

The dispute between Abbott’s expert and the defense experts was whether testing with

whole blood would lead to oxygen sensitivity of greater than 5%.

6 The ’551 invention’s oxygen sensitivity, characterized as “minimal,” is only slightly better at 4%. See ’551 patent col.7 ll.18–20.

2008-1511, -1512, -1513, -1514, -1595 12 The district court made no explicit finding that the ’382 patent would have

enabled one having ordinary skill in the art to make and use a membraneless sensor.

The district court did find, however, that the ’382 patent exhibits “very low oxygen

sensitivity” comparable to that disclosed in the ’551 patent, and therefore the ’382

patent would not have any issues with oxygen sensitivity. See Trial Opinion, 565 F.

Supp. 2d at 1104. This finding is not clearly erroneous. Although there was conflicting

testimony on this issue, the district court could properly credit Bayer’s expert, Dr.

Turner, who testified that Example 8 of the ’382 patent showed that there would be no

greater than 5% oxygen sensitivity when testing with whole blood because the buffer

test showed only 5% oxygen sensitivity and whole blood would necessarily have a lower

oxygen sensitivity than the buffer solution. In light of the district court’s finding that the

’382 patent exhibits “very low oxygen sensitivity” comparable to that of the ’551 patent,

we reject Abbott’s contention that the oxygen sensitivity of the ’382 patent does not

enable a membraneless sensor.

Abbott also argues that even if the ’382 patent disclosed a membraneless sensor

for whole blood, the ’551 patent would not have been obvious because the ’382 patent’s

disclosure did not provide a reasonable expectation of success. Here, Abbott

essentially recycles its contentions regarding the conventional wisdom of those skilled in

the art concerning the need for a membrane and the oxygen sensitivity issue. 7 For the

7 Abbott also relies on two other alleged differences between the ’382 and ’551 patents: (1) the use of screen printing to make the ’551 electrode, and (2) the use of oxidized electrodes on the ’382 patent as opposed to the ’551 patent’s nonoxidized electrodes. However, these distinctions do not relate to any claimed elements in the ’551 patent, and they can hardly be relied upon to show the ’551 patent’s nonobviousness.

2008-1511, -1512, -1513, -1514, -1595 13 reasons discussed above rejecting those contentions, Abbott’s claims that there was no

reasonable expectation of success similarly fail.

C Motivation to Combine Prior Art References

The district court found that one skilled in the art would have “readily thought to

combine” the ’382 patent and the ’410 patent to create the membraneless sensor for

whole blood of the ’551 patent. Trial Opinion, 565 F. Supp. 2d at 1123. While the ’382

patent discloses a membraneless sensor, the ’410 patent teaches the use of a

disposable strip-type electrode cartridge that attaches to readout circuitry. Together,

these disclose every element of the ’551 patent’s blood glucose test strip. Abbott

argues that there was no motivation to combine these references because persons of

skill in the art would not have “combined a sensor that they did not believe would work

in whole blood with the other components to produce a ‘seemingly inoperative’ test strip

for testing whole blood.” Pls.-Appellants’ Br. 37–38.

Abbott’s characterization of the ’382 patent’s disclosure of a membraneless

sensor as “seemingly inoperative” simply repeats its arguments related to enablement

and reasonable expectation of success. In light of our conclusions that the district court

did not clearly err in finding that the ’382 patent disclosed a membraneless sensor and

that those with ordinary skill in the art would have expected such a membraneless

sensor to work, we conclude that the district court did not clearly err in finding that those

with ordinary skill would have been motivated to combine this sensor in a disposable

form (the contribution of the ’410 patent). Dr. Turner testified that the field of biosensors

in the early 1980s was a “sophisticated field.” J.A. 2523. He also testified that at the

time, persons with ordinary skill in the art recognized the advantages to the strip-type

2008-1511, -1512, -1513, -1514, -1595 14 format for home testing, which would have motivated a person to put the membraneless

sensor on a strip. Abbott failed to present any expert evidence to rebut that expert

testimony. Therefore, the district court did not clearly err in finding that a motivation to

combine existed.

D Secondary Considerations: Commercial Success

Abbott contends that even if the district court were correct in finding a prima

facie case of obviousness, that finding is overcome by evidence of commercial success.

The district court concluded that Abbott failed to demonstrate a sufficient nexus

between the claims of the ’551 patent and the success of Abbott’s Exactech product.

Trial Opinion, 565 F. Supp. 2d at 1124. This finding is not clearly erroneous.

In order to overcome a finding of obviousness by demonstrating commercial

success, “[a] nexus between commercial success and the claimed features is required.”

Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir.

2000). “[T]he asserted commercial success of the product must be due to the merits of

the claimed invention beyond what was readily available in the prior art.” J.T. Eaton &

Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997).

Abbott argues on appeal that the district court erred by requiring Abbott to show

that the commercial success of the Exactech product was attributable to the ’551 patent,

and that Abbott was entitled to a presumption that the commercial success was due to

the invention claimed in the ’551 patent. Abbott claims that “if the marketed product

embodies the claimed features, and is coextensive with them, then a nexus is presumed

and the burden shifts to the party asserting obviousness to present evidence to rebut

the presumed nexus.” Brown & Williamson, 229 F.3d at 1130.

2008-1511, -1512, -1513, -1514, -1595 15 Abbott is incorrect in contending that it was entitled to the presumption of a

nexus. This is not a situation where the success of a product can be attributed to a

single patent, because Abbott’s Exactech product embodied at least two patents: the

’382 patent and the ’551 patent. Abbott’s expert, Dr. Johnson, admitted that the

Exactech strips met all of the limitations of claim 1 of the ’382 patent. Furthermore, for

the fifteen years that the product was on the market—during which the ’382 patent was

valid and in force for the entire period save for the final three months—Abbott marked

the product with the ’382 patent, both before and after the ’551 patent issued. As such,

there is no presumption that the product’s success was due only to the ’551 patent.

The defendants presented uncontroverted evidence demonstrating that the

Exactech product’s success was due to features already present in prior art such as the

’382 patent. Abbott’s primary witness on commercial success conceded that the

Exactech product was successful because it offered “fast disposal for whole blood that

could directly be put onto the strip, [provided] the reading, and then basically that strip

[was] disposable.” J.A. 2640. In addition, the defendants presented numerous

declarations that Abbott had filed with the PTO during the prosecution of the ’551 patent

describing the success of the Exactech strips, all of which attested to the product’s

“ease of use, short user training period, and ability to consistently obtain accurate test

results,” J.A. 6969, and “[t]he electrode configuration (allowing a small sample size), the

size of the test strips, and the ease with which they can be stored, used and disposed

of,” J.A. 6985. Abbott offered nothing to contradict this evidence and show that the

commercial success of the Exactech product was due to the lack of a protective

membrane over the sensor electrode. Under these circumstances, the district court did

2008-1511, -1512, -1513, -1514, -1595 16 not err in rejecting Abbott’s assertion that commercial success supported a finding of

nonobviousness.

* * *

For the reasons stated above, we find no error with the district court’s conclusion

that claims 1–4 of the ’551 patent would have been obvious in light of the prior art.

II Inequitable Conduct in the Prosecution of the ’551 Patent

Following the bench trial, the district court also held the ’551 patent

unenforceable for inequitable conduct based on a failure to disclose statements made to

the European Patent Office (“EPO”) during a revocation proceeding of the European

counterpart to the ’382 patent. Trial Opinion, 565 F. Supp. 2d at 1127.

“[I]nequitable conduct includes affirmative misrepresentation of a material fact,

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

coupled with an intent to deceive.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363,

1378 (Fed. Cir. 2008) (quoting Pharmacia Corp. v. Par Pharm., Inc., 417 F.3d 1369,

1373 (Fed. Cir. 2005)) (quotation marks omitted). “The party asserting inequitable

conduct must prove a threshold level of materiality and intent by clear and convincing

evidence. The court must then determine whether the questioned conduct amounts to

inequitable conduct by balancing the levels of materiality and intent, ‘with a greater

showing of one factor allowing a lesser showing of the other.’” Digital Control, Inc. v.

Charles Mach. Works, 437 F.3d 1309, 1313 (Fed. Cir. 2006) (quoting Union Pac. Res.

Co. v. Chesapeake Energy Corp., 236 F.3d 684, 693 (Fed. Cir. 2001)) (citations

omitted).

2008-1511, -1512, -1513, -1514, -1595 17 The ultimate finding of inequitable conduct is reviewed under an abuse of

discretion standard. Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867,

876 (Fed. Cir. 1988) (en banc). We review the underlying factual determinations of

materiality and intent for clear error, however. Star Scientific, Inc. v. R.J. Reynolds

Tobacco Co., 537 F.3d 1357, 1365 (Fed. Cir. 2008).

The penalty for inequitable conduct is severe, as an entire patent is rendered

unenforceable. Therefore it is important that courts maintain a high standard. “Just as

it is inequitable to permit a patentee who obtained his patent through deliberate

misrepresentations or omissions of material information to enforce the patent against

others, it is also inequitable to strike down an entire patent where the patentee only

committed minor missteps or acted with minimal culpability or in good faith.” Star

Scientific, 537 F.3d at 1366. This is one of those rare cases in which a finding of

inequitable conduct is appropriate, particularly in light of the critical nature of the

representations to the PTO in securing allowance of the ’551 patent and the district

court’s careful and thorough findings as to materiality and intent.

A Materiality

There is no question that the PTO rules, in particular Rule 56, require the

submission of any known information that contradicts information submitted to the PTO:

Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the [PTO], which includes a duty to disclose to the [PTO] all information known to that individual to be material to patentability . . . . (b) Under this section, information is material to patentability when it is not cumulative to information already of record or being made of record in the application, and ... (2) It refutes, or is inconsistent with, a position the applicant takes in:

2008-1511, -1512, -1513, -1514, -1595 18 (i) Opposing an argument of unpatentability relied on by the [PTO], or (ii) Asserting an argument of patentability.

37 C.F.R. § 1.56(a)–(b). These rules are directly relevant to the materiality component

of inequitable conduct because “if a misstatement or omission is material under the . . .

Rule 56 standard, it is material [for purposes of inequitable conduct].” Digital Control,

437 F.3d at 1316; see also Pharmacia, 417 F.3d at 1373 (affirming a finding of

inequitable conduct where a prior article by a declarant contradicted his declaration to

the PTO). The district court found that statements made by Abbott’s predecessor to the

EPO were highly material to the prosecution of the ’551 patent because they

contradicted representations Abbott made to the PTO regarding the membraneless

sensor disclosed in the ’382 patent. Trial Opinion, 565 F. Supp. 2d at 1112–13. This

finding is not clearly erroneous, and indeed is clearly correct.

1 PTO Representations

The original application that led to the ’551 patent was filed in 1984. Over the

next thirteen years, Abbott pursued the patent through half-a-dozen continuation

applications that were repeatedly rejected for anticipation and obviousness, including

repeated rejections over the ’382 patent. In 1997, Abbott formulated a new argument

for patentability during a brainstorming session attended by Lawrence Pope (“Pope”),

Abbott’s patent attorney, and Dr. Sanghera, Abbott’s Director of Research and

Development. Thereafter, new claims were drafted including electrochemical sensors

lacking a membrane. During an interview with the examiner, Pope presented the new

claims with the argument that the claims of the application were not anticipated or

obvious because the claims taught a new glucose sensor that did not require a

protective membrane when testing whole blood. Pope and the examiner specifically

2008-1511, -1512, -1513, -1514, -1595 19 discussed the “[o]ptionally, but preferably” language in the ’382 patent. In Pope’s own

summary of the interview, he stated that he “pointed out [to the examiner] that [the ’382

patent] teaches that active electrodes designed for use with whole blood require a

protective membrane.” J.A. 7644. The examiner then agreed that if Abbott produced

“an affidavit or other evidentiary showing that at the time of the invention such a

membrane was considered essential [for whole blood, it] would overcome [the ’382

patent’s] teaching.” J.A. 7639.

In accordance with that agreement, Dr. Sanghera submitted a declaration to the

PTO urging that the language of the ’382 patent concerning the membraneless sensor

should not be taken at face value. It stated in relevant part:

[B]ased on his historical knowledge he is confiednt [sic] that on the filing date of the earlist [sic] application leading to the present application on June 6, 1983 and for a considerable time thereafter one skilled in the art would have felt that an active electrode comprising an enzyme and a mediator would require a protective membrane if it were to be used with a whole blood sample. Therefore, he is sure that one skilled in the art would not read lines 63 to 65 of column 4 of U.S. Patent No. 4,545,382 to teach that the use of a protective membrane with a whole blood sample is optionally or merely preferred.

J.A. 7637 (emphases added). Pope, in submitting the affidavit, further represented:

The art continued to believe [following the ’382 patent] that a barrier layer for whole blood sample was necessary for a considerable period. . . . One skilled in the art would not have read the disclosure of the Higgins patent (U.S. 4,545,382) as teaching that the use of a protective membrane with whole blood samples was optional. He would not, especially in view of the working examples, have read the “optionally, but preferably” language at line 63 of column [4] as a technical teaching but rather mere patent phraseology. This is supported by the Declaration under 37 C.F.R. 1.132 of Gordon Sanghera which accompanies the present amendment. .... . . . The applicants have established that a new claim limitation supported by the present application provides a patentable distinction over

2008-1511, -1512, -1513, -1514, -1595 20 U.S. Patent No. 4,545,382, the key reference in the prosecution of the present application and its predecessors. There is no teaching or suggestion of unprotected active electrodes for use with whole blood specimens in this patent or the other prior art of record in this application.

J.A. 7645–46 (emphases added). Shortly thereafter, the PTO allowed the ’551 patent

with the newly added claims for a membraneless sensor.

2 EPO Representations

The district court found that Abbott had made directly contradictory

representations to the EPO concerning the teaching of the ’382 patent in European

Patent EP 0 078 636 (“the ’636 patent”)—a counterpart to the ’382 patent with virtually

identical specifications—and that Abbott had not disclosed those contradictory

representations to the PTO.

In 1993, the ’636 patent was revoked as obvious. One of the references the

EPO relied on was a German reference labeled D1. Abbott 8 argued to the EPO that the

D1 reference was distinguishable. On January 12, 1994, Abbott’s patent counsel

submitted to the EPO a brief distinguishing the ’636 patent from the D1 reference,

stating:

Contrary to the semipermeable membrane of D1, the protective membrane optionally utilized with the glucose sensor of the patent is [sic] suit is not controlling the permeability of the substrate (as set forth above under IV.2., in the membrane of D1 the permeability for the substrate must be kept on a low value to achieve a linear relationship between the measures [sic] currency and the substrate concentration in the test solution). Rather, in accordance with column 5, lines 30 to 33 of the patent in suit: “Optionally, but preferably when being used on live blood, a protective membrane surrounds both the enzyme and the mediator layers, permeable to water and glucose molecules.”

8 At this time, the party operating before the EPO was Medisense, a predecessor to both Therasense and Abbott. We use the term “Abbott” to include Medisense.

2008-1511, -1512, -1513, -1514, -1595 21 See also claim 10 of the patent in suit as granted according to which the sensor electrode has an outermost protective membrane (11) permeable to water and glucose molecules. Finally, see Example 7 in column 10, lines 19 to 26 reporting that by using such a protective membrane the response time did not increase but from 24 to 60 sec. (without membrane) to 36 - 76 sec. (with membrane). Accordingly, the purpose of the protective membrane of the patent in suit, preferably to be used with in vivo measurements, is a safety measurement to prevent any course [sic] particles coming off during use but not a permeability control for the substrate.

J.A. 6530–31 (emphases added).

On May 23, 1995, Abbott’s patent counsel submitted another brief to the EPO

regarding the D1 reference and the ’636 patent. It again discussed the “[o]ptionally, but

preferably” language:

“Optionally, but preferably when being used on live blood, a protective membrane surrounds both the enzyme and the mediator layers, permeable to water and glucose molecules.” It is submitted that this disclosure is unequivocally clear. The protective membrane is optional, however, it is preferred when used on live blood in order to prevent the larger constituents of the blood, in particular erythrocytes from interfering with the electrode sensor. Furthermore it is said, that said protective membrane should not prevent the glucose molecules from penetration, the membrane is “permeable” to glucose molecules.

J.A. 6585 (emphases added).

The district court found that the EPO statements contradicted the PTO

representations in at least two significant ways. First, the district court found that by

describing the “[o]ptionally, but preferably” language as “unequivocally clear,” Abbott’s

EPO representations contradicted Abbott’s representations to the PTO that a person

having ordinary skill in the art would have understood the phrase as mere “patent

phraseology” that did not convey a clear meaning. See Trial Opinion, 565 F. Supp. 2d

at 1110. Second, the district court noted that the EPO documents clearly explained that

2008-1511, -1512, -1513, -1514, -1595 22 membranes were merely preferred for live blood. Id. at 1109–10. The documents

identified reasons specifically directed toward live blood explaining why a membrane

was necessary, supporting the position that these problems did not exist for in vitro

testing of whole blood and that a membrane was not necessary for testing whole blood

in vitro. See id. at 1109. These findings are not clearly erroneous, and indeed are

manifestly correct.

3 Abbott’s Arguments

Abbott asserts that the district court erred in finding that the statements it made

to the EPO were inconsistent with the PTO statements. It contends that in the EPO, the

focus was on distinguishing the semipermeable membrane of the D1 reference from the

protective, permeable membrane of the ’636 patent. Abbott is correct that such a

distinction was made in the EPO submissions. However, that is not the only point

Abbott made in the EPO to distinguish the two references. The district court correctly

found that Abbott also argued before the EPO that the protective membrane of the ’636

patent was optional. The optional nature of the membrane was not irrelevant to the

distinction of the D1 reference’s semipermeable membrane because the optional nature

of the membrane proved that it was not the type of membrane required by the D1

reference, as Abbott appears to recognize. 9 Abbott’s representation was particularly

clear in the May 1995 submission. In labeling the “[o]ptionally, but preferably” language

“unequivocally clear,” Abbott emphasized the alleged plain meaning of the language in

9 In describing the distinction made before the EPO between the ’636 patent and the D1 reference, Abbott states in its reply brief, “If that kind of [semipermeable] membrane is needed, it is needed whenever glucose is measured, regardless of the liquid—buffer, blood, or interstitial fluid. Thus, by showing that the ’382/’636 did not use

2008-1511, -1512, -1513, -1514, -1595 23 the specification quoted in the immediately preceding sentence and reinforced that

meaning in the following sentence, where it stated, “The protective membrane is

optional, however, it is preferred when used on live blood in order to prevent the larger

constituents of the blood, in particular erythrocytes from interfering with the electrode

sensor.” J.A. 6585. This sentence clearly was not directed to permeability. There can

be no doubt that Abbott was making two assertions in this submission. It first explained

that the protective membrane is optional but preferred when used on live blood and that

the ’382 patent language was “unequivocally clear” on this point. Then, using the

transition “furthermore,” it expressed its second point about the permeability of the

membrane.

The dissent suggests a somewhat different theory to explain Abbott’s

representations to the PTO—a theory that significantly was not addressed by Abbott

itself. Abbott’s theory is that the “unequivocally clear” statement of the second EPO

submission was directed to the permeability of the membrane to water and glucose. As

discussed above, this theory ignores the context of the “unequivocally clear” statement

and particularly the sentence immediately following the “unequivocally clear” statement,

which says nothing about permeability. The dissent attempts to fill this gaping hole in

Abbott’s argument by suggesting that it would be reasonable to interpret the sentence

following the “unequivocally clear” statement as also directed to how the membrane

functioned, i.e., that it was “unequivocally clear” that it protected against fouling, rather

than that it was “unequivocally clear” that it was optional. With respect, Abbott’s EPO

statements cannot possibly be read in this manner.

a membrane for at least some liquids, [Abbott] proved that it did not use the D1’s

2008-1511, -1512, -1513, -1514, -1595 24 The “unequivocally clear” statement is tied directly to the optional nature of the

membrane when used with whole blood and other fluids. The three sentences in

question read:

“Optionally, but preferably when being used on live blood, a protective membrane surrounds both the enzyme and the mediator layers, permeable to water and glucose molecules.” It is submitted that this disclosure is unequivocally clear. The protective membrane is optional, however, it is preferred when used on live blood in order to prevent the larger constituents of the blood, in particular erythrocytes from interfering with the electrode sensor.

J.A. 6585. On its face, the description of the membrane’s protective function was itself

designed to establish why the membrane was optional with whole blood and other

fluids, but preferred with live blood. It was preferred with live blood because it protected

against fouling. Both with respect to whole blood and live blood, it was “unequivocally

clear” that the membrane was optional (whole blood and other fluids) or preferred (live

blood). Necessarily, it was “unequivocally clear” that the membrane was not required

for either whole blood or live blood. Thus, this is not a situation such as that referred to

in Scanner Technologies Corp. v. ICOS Vision Systems Corp. in which “multiple

reasonable inferences” as to the meaning of representations could be drawn from the

evidence and there existed an “equally reasonable inference” favorable to Abbott. See

528 F.3d 1365, 1376 (Fed. Cir. 2008).

Indeed, Abbott in oral argument agreed that the EPO statements were a

“recharacterization of the sentence that was already before the [PTO] examiner.” Oral

Argument at 40:40. Pope in his testimony agreed that the plain English reading of what

glucose-controlling membrane.” Pl.-Appellants’ Reply Br. 13 (citation omitted).

2008-1511, -1512, -1513, -1514, -1595 25 Abbott told the EPO was contrary to what Abbott told the PTO. 10 To deprive an

examiner of the EPO statements—statements directly contrary to Abbott’s

representations to the PTO—on the grounds that they were not material would be to

eviscerate the duty of disclosure. Moreover, if this could be regarded as a close case,

which it is not, we have repeatedly emphasized that the duty of disclosure requires that

the material in question be submitted to the examiner rather than withheld by the

applicant. See LNP Eng’g Plastics, Inc. v. Miller Waste Mills, Inc., 275 F.3d 1347, 1361

(Fed. Cir. 2001) (“[W]hen a question of materiality is close, a patent applicant should err

on the side of disclosure.”); LaBounty Mfg., Inc. v. U.S. Int’l Trade Comm’n, 958 F.2d

1066, 1076 (Fed. Cir. 1992) (“[A close case] makes it all the more necessary that the

[reference] should [be] disclosed to the examiner. Close cases should be resolved by

disclosure, not unilaterally by the applicant.”).

Abbott nonetheless contends that lawyer argument about prior art is not

information material to patentability and that since both the EPO and the PTO

representations were merely argument, any inconsistency between the two could not be

material. This court has held that representations made to the PTO concerning the

content of prior art “amount[] to mere attorney argument and our precedent has made

clear that an applicant is free to advocate its interpretation of its claims and the

teachings of the prior art.” Innogenetics, 512 F.3d at 1379. However, all of the cases

Abbott cites involve patentees who simply made representations to the PTO about prior

10 Pope agreed that “as a matter of normal English construction,” the “unequivocally clear” statement “refers to [the ‘[o]ptionally, but preferably’ language] and refers to all of it.” J.A. 2990. Thus, according to Pope, “if [the ‘[o]ptionally, but preferably’] language stood alone, . . . it would definitely indicate that the use of a protective membrane was optional or preferable.” J.A. 2988.

2008-1511, -1512, -1513, -1514, -1595 26 art in order to secure the allowance of their patents. See id.; Young v. Lumenis, Inc.,

492 F.3d 1336, 1344 (Fed. Cir. 2007); Life Techs., Inc. v. Clontech Labs., Inc., 224 F.3d

1320, 1326 (Fed. Cir. 2000); Azko N.V. v. U.S. Int’l Trade Comm’n, 808 F.2d 1471,

1485 (Fed. Cir. 1986). None of these cases involved a situation in which contradictory

arguments made in another forum were withheld from the PTO. They do not speak to

the applicant’s obligation to advise the PTO of contrary representations made in another

forum. Before the EPO, Abbott made statements that contradicted the representations

Abbott made to the PTO regarding the ’382 patent. An applicant’s earlier statements

about prior art, especially one’s own prior art, are material to the PTO when those

statements directly contradict the applicant’s position regarding that prior art in the PTO.

See 37 C.F.R. § 1.56(b)(2). In any event, the representations to the PTO were not

merely lawyer argument; they were factual assertions as to the views of those skilled in

the art, provided in affidavit form.

The district court’s finding that the EPO statements were highly material because

they contradicted the position taken before the PTO was not clearly erroneous and was

strongly supported by the uncontradicted record.

B Intent

In determining whether a failure to disclose material information was intentional,

“the involved conduct, viewed in light of all the evidence, including evidence indicative of

good faith, must indicate sufficient culpability to require a finding of intent to deceive.”

Kingsdown, 863 F.2d at 876. Because direct evidence of deceptive intent is rarely

available, such intent can be inferred from indirect and circumstantial evidence. Star

Scientific, 537 F.3d at 1366.

2008-1511, -1512, -1513, -1514, -1595 27 In concluding that Abbott’s representatives—Pope and Dr. Sanghera—intended

to deceive the PTO by withholding the EPO documents, the district court made five

findings: (1) that the statements made to the PTO concerning the prior art ’382 patent

were absolutely critical in overcoming the examiner’s earlier rejections of the claims of

the ’551 patent; (2) that the EPO statements would have been very important to an

examiner because they contradicted the representations made to the PTO; (3) that

Pope and Dr. Sanghera both knew of the EPO statements and consciously withheld

them from the PTO; (4) that neither Pope nor Dr. Sanghera provided a credible

explanation for failing to submit the EPO documents to the PTO; and (5) that Pope’s

and Dr. Sanghera’s explanations for withholding the EPO documents were so incredible

that they suggested intent to deceive. See Trial Opinion, 565 F. Supp. 2d at 1113–16.

The first of these is undisputed. The second is not clearly erroneous as discussed

above. The third is also undisputed; Pope and Dr. Sanghera together evaluated the

documents from the EPO proceedings during the prosecution of the ’551 patent and

made a conscious decision to withhold them from the PTO.

The district court’s fourth and fifth findings regarding intent are based on the

district court’s assessment of witness credibility. “[D]etermination of the credibility of the

witnesses is within the discretion of the presiding official who heard their testimony and

saw their demeanor,” Griessenauer v. Dep’t of Energy, 754 F.2d 361, 364 (Fed. Cir.

1985), such that a judge’s credibility determinations are “virtually unreviewable,”

Hambsch v. Dep’t of the Treasury, 796 F.2d 430, 436 (Fed. Cir. 1986). As such, “[t]his

court may not reassess, and indeed is incapable of reassessing, witness credibility and

motive issues on review.” LNP Eng’g, 275 F.3d at 1361.

2008-1511, -1512, -1513, -1514, -1595 28 The district court judge had the opportunity to observe both Pope’s and Dr.

Sanghera’s testimony during the bench trial and found their explanations neither

plausible nor credible. In fact, the court explicitly noted that “Attorney Pope did not

prove to be a convincing trial witness.” Trial Opinion, 565 F. Supp. 2d at 1113. The

district court similarly found Dr. Sanghera’s testimony not to be credible, expressing

twice in its opinion that his demeanor was unconvincing. See id. at 1115 (“As a trial

witness, it must be said that Dr. Sanghera was impeached on substantive points with

his prior inconsistent statements and exhibited an unconvincing demeanor.” (citation

omitted)); id. at 1116 (“His unconvincing trial demeanor has been a factor in this

determination.”).

These findings are amply supported. One example will suffice. In attempting to

dismiss the EPO statements as merely cumulative, Pope was confronted with the need

to explain the May 1995 statement that the “[o]ptionally, but preferably” language was

“unequivocally clear.” Pope testified that “it was my understanding at the time that what

was unequivocally clear was that that the protective membrane, which was sometimes

required by the ’636 patent was permeable to water and glucose.” J.A. 2983. This is

contrary to the explicit meaning of the May 1995 statement, as the district court found.

When the district court asked Pope to further explain the sentence, “It is submitted that

this disclosure is unequivocally clear,” Pope responded:

I would agree with Your Honor that as a matter of normal English construction, the sentence, “it is submitted” refers to what comes immediately before and refers to all of it, but as a patent attorney reading this document and making a judgment call, I was making my judgment call on what was being conveyed, what information was important, what position was being taken. And in that context, I didn’t believe that they were trying to convey anything about the optional but preferably language.

2008-1511, -1512, -1513, -1514, -1595 29 J.A. 2990. The district court did not err in finding that Pope’s “trial explanation for his

withholding [the EPO submissions] was not plausible and he was not credible” and that

Pope “acted with specific intent to deceive [the examiner] and the PTO,” Trial Opinion,

565 F. Supp. 2d at 1113, particularly in view of Pope’s admission that the EPO

statement’s “normal English construction” directly contradicted his representations to

the PTO on a critical issue.

So too Dr. Sanghera testified that he considered it appropriate to withhold from

the PTO his own knowledge, reflected in the EPO submission, that “general English

usage” contradicted the representations that he had made to the PTO. He testified that

“in general English usage, [he] would not use the terms ‘optional’ or ‘preferable’ to

describe something that is required,” and he could not recall “any instance during the

course of [his] scientific career in which [he] use[d] the terms ‘optional’ or ‘preferable’ to

refer to something that was required.” J.A. 3009. Yet like Pope, Dr. Sanghera testified

that representations to the EPO confirming that the language was “unequivocally clear”

could be withheld. The district court did not err in finding bad faith.

The district court’s conclusion of intent also finds support in the fact that Pope

relied on Dr. Sanghera, who was not a person having ordinary skill in the art at the time

of the ’382 patent, to provide a declaration to the PTO regarding the teachings of the

’382 patent rather than the inventors of the patent, who appear to have had a view quite

contrary to Abbott’s opinion as to the language of the ’382 patent. Dr. Higgins, an

inventor on both the ’382 and the ’551 patents, testified that even the phrase “preferably

when being used on live blood” meant that “you would probably need a membrane, but

not definitely.” J.A. 3104. He felt that Dr. Sanghera’s declaration statements

2008-1511, -1512, -1513, -1514, -1595 30 concerning whole blood were simply “wrong.” J.A. 3708. “Had [Dr. Sanghera] been

around in the field, working in the field in 1983, and he had seen our patent

specification, I believe he, as a person skilled in the art, would have concluded that the

membrane may not be necessary.” J.A. 3707–08.

Finally, Abbott argues that Dr. Sanghera demonstrated a lack of intent to deceive

by satisfying his duty to disclose by providing the EPO documents to Pope. See 37

C.F.R. § 1.56(d) (“Individuals other than the attorney, agent or inventor may comply with

this section by disclosing information to the attorney, agent or inventor.”). However, the

district court was correct to note that by submitting a declaration to the PTO, Dr.

Sanghera was still obligated to avoid intentional deception. See Trial Opinion, 565 F.

Supp. 2d at 1115. “Cases involving affidavits or declarations are held to a higher

standard.” Innogenetics, 512 F.3d at 1379. This court has in the past expected more of

declarants before the PTO. In Ferring B.V. v. Barr Laboratories, Inc., we held that the

failure to disclose possible biases of the declarants constituted a material omission

where the declarations were submitted to overcome a prior art rejection. 437 F.3d

1181, 1190 (Fed. Cir. 2006). Refac International, Ltd. v. Lotus Development Corp.

involved similar circumstances in which declarations submitted to establish enablement

failed to disclose possible biases. 81 F.3d 1576, 1581 (Fed. Cir. 1996). In this case, it

was Dr. Sanghera’s duty to avoid intentional deception in his declaration before the

PTO, and merely disclosing the EPO documents to Pope did not obviate that duty.

The dissent sets up various straw men that are irrelevant to the district court’s

finding of intent and the majority’s affirmance of the intent issue. Thus, the dissent

urges that Pope and Dr. Sanghera were not aware of U.S. Patent No. 4,388,166 to

2008-1511, -1512, -1513, -1514, -1595 31 Suzuki et al.—a prior art reference disclosing advantages and disadvantages of using

membraneless sensors with whole blood—and were not aware of Dr. Higgins’s contrary

interpretation of the “[o]ptionally, but preferably” language. This is undisputed; the

district court did not base its finding on intent on the existence of such knowledge. Nor

did the district court find that Abbott misrepresented Dr. Sanghera’s qualifications before

the PTO.

More to the point is the dissent’s urging that Pope’s and Dr. Sanghera’s

testimonies reflect a plausible conclusion that the EPO submissions were not material.

For the reasons described above, the district court was clearly correct in concluding that

the explanations offered by Pope and Dr. Sanghera were not plausible. The dissent’s

efforts to come up with new theories of plausibility (discussed above in connection with

materiality) are both unconvincing and beside the point. Pope’s and Dr. Sanghera’s

intent must be judged by their asserted beliefs at the time, not by some imputed theory

that Abbott itself does not even offer on appeal.

Accordingly, the district court did not clearly err in finding that Pope and Dr.

Sanghera both intended to deceive the PTO by withholding the EPO documents.

Because the district court’s findings that the EPO submissions were highly

material to the prosecution of the ’551 patent and that Pope and Dr. Sanghera intended

to deceive the PTO by withholding those submissions were not clearly erroneous, the

district court did not abuse its discretion in holding the ’551 patent unenforceable due to

inequitable conduct.

2008-1511, -1512, -1513, -1514, -1595 32 III Noninfringement of the ’164 and ’745 Patents

On summary judgment, the district court concluded that there was no issue of

material fact as to whether the BD Test Strip infringes the ’164 and ’745 patents

because the BD Test Strip does not satisfy the “non-flowing manner” limitation present

in both patents. Abbott contends that the district court’s decision is based on an

erroneous claim construction. We review both the district court’s grant of summary

judgment and its claim construction de novo. AquaTex Indus., Inc. v. Techniche

Solutions, 479 F.3d 1320, 1328 (Fed. Cir. 2007); Cybor Corp. v. FAS Techs., Inc., 138

F.3d 1448, 1456 (Fed. Cir. 1998) (en banc).

The ’164 patent describes a glucose sensor for blood samples smaller than one

microliter. The ’745 patent describes a glucose sensor for blood samples smaller than

one microliter that employs diffusible mediators. A limitation in each of Abbott’s

asserted claims in the ’164 and ’745 patents requires that the blood sample being

analyzed be held within the strip in a “non-flowing manner.” Claim 16 of the ’164 patent

is representative in this respect:

16. A method for determining a concentration of an analyte [such as glucose] in a body fluid of a patient, comprising the steps of: creating an unassisted flow of a body fluid from the patient; transporting a portion of the body fluid into an analyte sensor configured and arranged to determine the concentration of the analyte from 500nL or less of body fluid; holding the sample in a non-flowing manner within a sample chamber of the analyte sensor; and determining the concentration of the analyte in the body fluid from the portion of the body fluid transported into the analyte sensor.

’164 patent col.25 l.66–col.26 l.11 (emphasis added). The district court construed the

claim term “holding the sample in a non-flowing manner within the sample chamber of

the analyte sensor” to mean that “the sample is not moving in the sample chamber

2008-1511, -1512, -1513, -1514, -1595 33 during the measurement.” Summary Judgment Order, 560 F. Supp. 2d at 854. Even a

sample “flowing at a very slow rate” is “directly at odds with the plain and ordinary

meaning of ‘non-flowing,’” the court stated. Id.

At summary judgment, the district court applied its construction, concluding that

the limitation is not satisfied even if the only motion present in the sample is convective

flow. See id. at 856. Abbott argues that such an expansive reading is unwarranted

because all liquids have at least a minor amount of convective flow, pointing to the

uncontroverted testimony of its expert that “[t]here is always . . . at least a minor amount

of convection occurring within any liquid.” J.A. 10553. We agree with Abbott. Here any

reasonable construction must allow for certain types of motion that are inherent within

liquids, including convective flow and Brownian motion. 11

Even though we reject the district court’s broad reading of the “non-flowing

manner” limitation, we also reject Abbott’s alternative construction. Abbott contends

that “flow” means to move in a stream and that the proper construction of the “non-

flowing manner” limitation should be that the sample is not moving through the sample

chamber during measurement. Abbott analogizes to a river or stream that stops flowing

when dammed. However, the plain meaning of “flow” is not so limited. A dammed river

or stream may no longer flow along the same path as it once did, but the water will

continue to flow within the lake behind the dam—a flow that is more than mere

convective flow. The sample chamber on the BD Test Strip is no different. Blood can

flow through the sample chamber or it can flow within the sample chamber. In either

11 The district court did not decide whether Brownian motion would be covered by the claim construction. Summary Judgment Order, 560 F. Supp. 2d at 856.

2008-1511, -1512, -1513, -1514, -1595 34 case the blood is still flowing. We construe a “non-flowing manner” to mean that a

sample “is not moving in the sample chamber during the measurement,” other than

motion attributable to convective flow, Brownian motion, or other qualities inherent to all

liquids.

Under the correct claim construction, summary judgment of noninfringement was

still appropriate. Abbott on appeal does not contend that the BD Test Strip does not

evidence flow under the claim construction that we have adopted, and indeed Abbott’s

expert admitted that there is a “slight swirling in the chamber.” J.A. 12258. BD/Nova

presented uncontradicted evidence that the BD Test Strip does not infringe Abbott’s

’164 and ’745 patents because the blood sample flows within the strip’s measurement

zone during the entire measurement period. Expert testimony and numerous video

recordings showed that blood samples on the BD Test Strip exhibit a swirling motion.

The evidence also showed that the swirling motion persists during the entire five-second

measuring time of the BD Test Strip. Therefore, on this record, summary judgment of

noninfringement of the ’164 and ’745 patents by the BD Test Strip was proper.

IV Anticipation of ’745 Patent Claims

On summary judgment, the district court also concluded that there was no

material issue of fact as to the anticipation of claims 1–5, 8, 21–23, 28, 31, and 34 of the

’745 patent because PCT application WO 98/35225 (“the ’225 reference”) already

disclosed diffusible mediators. Summary Judgment Order, 560 F. Supp. 2d at 875.

“This court reviews a ruling of summary judgment de novo. Although anticipation under

35 U.S.C. § 102 is a question of fact, it may be decided on summary judgment if the

2008-1511, -1512, -1513, -1514, -1595 35 record reveals no genuine dispute of material fact.” Golden Bridge Tech., Inc. v. Nokia,

Inc., 527 F.3d 1318, 1321 (Fed. Cir. 2008) (citation omitted).

The ’225 reference contains the same disclosure as the ’164 patent. Summary

Judgment Order, 560 F. Supp. 2d at 874. It describes a glucose sensor for blood

samples smaller than one microliter. The primary improvement of the ’745 patent over

the ’225 reference and the ’164 patent is the use of diffusible or leachable mediators

with such sensors. Claim 1 of the ’745 patent reads:

1. A method for determining a concentration of glucose in a sample, comprising the steps of: (a) contacting a sample with an electrochemical sensor comprising: (i) an electrode pair comprising a working electrode and a counter electrode, wherein the working electrode and counter electrode are separated by a closest distance in a range of 200 to 1000 µm; (ii) a measurement zone positioned adjacent to the working electrode and the counter electrode, wherein the measurement zone is sized to contain a volume of no more than about 1 µL of the sample; and (iii) an analyte-responsive enzyme and a diffusible redox mediator disposed in the measurement zone; (b) holding the sample within the measurement zone in a non-flowing manner; (c) generating a sensor signal at the working electrode within a measurement period of no greater than about 5 minutes, wherein a background signal that is generated by the redox mediator is no more than five times a signal generated by oxidation or reduction of 5 mM of glucose; and (d) determining the concentration of the glucose using the sensor signal.

’745 patent col.61 ll.39–63 (emphases added).

On appeal, Abbott challenges only whether the ’225 reference disclosed the

“diffusible redox mediator” limitation and the “background signal” limitation. However,

Abbott did not argue the “background signal” issue to the district court in its opposition

to summary judgment. See Summary Judgment Order, 560 F. Supp. 2d at 871–72.

2008-1511, -1512, -1513, -1514, -1595 36 Therefore, Abbott can not do so now on appeal and has waived the issue. See

Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1296 (Fed. Cir. 2009) (“If a

party fails to raise an argument before the trial court, or presents only a skeletal or

undeveloped argument to the trial court, we may deem that argument waived on appeal

. . . .”).

Thus, the only remaining issue is the “diffusible redox mediator” element. The

district court concluded that there was no genuine issue of material fact on whether the

’225 reference disclosed the “diffusible redox mediator” element of the ’745 patent

because the ’225 reference “acknowledge[s] the possibility of using a leaching or

diffusing mediator, although clearly the drafters preferred those that did not leach or

diffuse.” Summary Judgment Order, 560 F. Supp. 2d at 873. Abbott argues that the

district court focused on a single passage out of context. However, the plain language

of the ’225 reference does disclose diffusible or leachable mediators.

The ’225 reference states:

Preferably, there is little or no leaching of the redox mediator away from the working electrode 22 into the sample during the measurement period, which is typically less than about 5 minutes. More preferably, the redox mediators of the present invention are bound or otherwise immobilized on the working electrode 22 to prevent undesirable leaching of the mediator into the sample. A diffusing or leachable (i.e., releasable) redox mediator is not desirable when the working and counter electrodes are close together . . . .

’225 reference at 9. The plain meaning of the passage implies that diffusible mediators

are contemplated, though they are not preferred. This conclusion is reinforced by the

claims of the ’225 reference. Claim 127 of the reference describes a method calling for

a “redox mediator.” It does not specify whether this mediator is a leachable or a non-

leachable mediator—that is, diffusible or non-diffusible. Claim 128, however,

2008-1511, -1512, -1513, -1514, -1595 37 encompasses “[t]he method of claim 127, wherein the redox mediator is a non-

leachable redox mediator,” i.e., a non-diffusible mediator. ’225 reference at 63. “[T]he

presence of a dependent claim that adds a particular limitation gives rise to a

presumption that the limitation in question is not present in the independent claim.”

Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc). Here, where

the dependent claim adds only the non-leachable (non-diffusible) mediator limitation,

this principle of claim construction compels the conclusion that the ’225 reference

claims diffusible as well as non-diffusible mediators in claim 127. As discussed above,

the claims here must be considered part of the disclosure.

Moreover, not a single expert in the case challenged the fact that the ’225

reference disclosed diffusible mediators, either explicitly or implicitly. While the

witnesses argued that the ’225 reference at least to some extent taught away from their

use, “[a] reference is no less anticipatory if, after disclosing the invention, the reference

then disparages it. . . . [T]he question whether a reference ‘teaches away’ from the

invention is inapplicable to an anticipation analysis.” Celeritas Techs., Ltd. v. Rockwell

Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998). Therefore, there was no triable issue

of material fact left for a jury to consider on the issue of whether the ’225 reference

disclosed diffusible mediators. As such, summary judgment on anticipation of the ’745

patent was proper.

CONCLUSION

For the aforementioned reasons, we affirm the district court’s judgment that

claims 1–4 of the ’551 patent are invalid due to obviousness and the entire patent is

unenforceable because of inequitable conduct. We also affirm the district court’s grant

2008-1511, -1512, -1513, -1514, -1595 38 of summary judgment of noninfringement of the ’164 and ’745 patents and invalidity of

claims 1–5, 8, 21–23, 28, 31, and 34 of the ’745 patent due to anticipation.

AFFIRMED

COSTS

No costs.

2008-1511, -1512, -1513, -1514, -1595 39 United States Court of Appeals for the Federal Circuit 2008-1511, -1512, -1513, -1514, -1595

THERASENSE, INC. (now known as Abbott Diabetes Care, Inc.) and ABBOTT LABORATORIES,

BECTON, DICKINSON AND COMPANY, and NOVA BIOMEDICAL CORPORATION,

Appeals from the United States District Court for the Northern District of California in consolidated case nos. 04-CV-2123, 04-CV-3327, 04-CV-3732, and 05-CV-3117, Judge William H. Alsup.

LINN, Circuit Judge, concurring-in-part and dissenting-in-part.

I am pleased to join Part III of the majority opinion affirming the judgment of

noninfringement, but I respectfully dissent from Part II affirming the district court’s

inequitable conduct ruling. With regard to Parts I and IV, I concur in the result and with

much of the majority’s reasoning in affirming the judgments of obviousness and

anticipation, but I write separately to express my disagreement with the majority’s

unnecessary, and in my view improper, reference in this case to the claims of the prior

art as a measure of what the prior art discloses. I. Inequitable Conduct

This case involves attorney arguments submitted to the EPO in the ’636 patent

(the European counterpart of the ’382 patent) over its interpretation, which allegedly

refute, or are inconsistent with, arguments submitted to the PTO in the ’551 patent over

the interpretation of the same language. The question for purposes of materiality here

is not whether Abbott’s arguments to the PTO were meritorious (i.e., that the word

“preferably” in the ’382/’636 patent would actually have been interpreted by a skilled

artisan to mean “required”); rather, the question is whether anything in Abbott’s EPO

submissions “refutes, or is inconsistent with,” its arguments to the PTO. 37 C.F.R.

§ 1.56(b)(2) (2009). Even if this information were material, however, the individuals who

owed a duty of disclosure to the PTO produced a good faith explanation as to why they

withheld the EPO submissions. Far from a mere blanket denial of deceptive intent, the

individuals’ explanation includes specific, detailed reasons as to why they subjectively

believed that the withheld information was immaterial during prosecution. Such an

explanation will defeat a charge of inequitable conduct if it is “plausible.” The question,

thus, is not whether it is plausible that the information is immaterial—a question asked

under the objective materiality prong—but rather, whether it is plausible that the

individuals subjectively believed that the reference was immaterial at the time they

withheld it—a question presented under the subjective intent prong.

I address these questions in turn.

A. Materiality

In Scanner Technologies Corp. v. ICOS Vision Systems Corp., 528 F.3d 1365

(Fed. Cir. 2008), we stated:

2008-1511, -1512, -1513, -1514, -1595 2 Whenever evidence proffered to show either materiality or intent is susceptible of multiple reasonable inferences, a district court clearly errs in overlooking one inference in favor of another equally reasonable inference. All reasonable inferences must be drawn from the evidence, and a judgment then rendered on the evidence as informed by the range of reasonable inferences. Where the rule is breached, no inequitable conduct may be found. The rule is necessary, for without it findings of inequitable conduct, with the punishment of unenforceability of the entire patent, could wrongly stand.

Id. at 1376 (footnote omitted). In that case, an applicant asked the PTO to expedite the

handling of its application in view of an allegedly infringing device on the market. The

applicant told the PTO that it had made a “rigid comparison” of the device with the

claims of the application, and that the device was on “open display” at a trade show. Id.

at 1372. The district court found these statements materially misleading. It inferred

from these statements that the applicant had actually seen the accused device when, in

fact, the device was in a black sealed box and an inspection of it would not have

revealed how the device meets the limitations of the claims. Although we

acknowledged that the district court’s interpretation of this language was “not

unreasonable,” we ultimately reversed, holding that, under an equally reasonable

favorable interpretation, a “rigid comparison” would not require physical inspection, and

that the device was on “open display” in the sense that the black box was located in a

public, as opposed to private, setting. Id. at 1376-77.

Accordingly, a district court “overlooks” a favorable inference, within the meaning

of Scanner Technologies, not simply when it ignores or fails to mention the possibility of

such an inference, but when it actually “adopt[s] an unfavorable inference . . . over an

equally reasonable favorable inference.” Id. at 1377. Citing this rule, we have stated

that an unfavorable inference “must not only be based on sufficient evidence and be

2008-1511, -1512, -1513, -1514, -1595 3 reasonable in light of that evidence, but it must also be the single most reasonable

inference able to be drawn from the evidence to meet the clear and convincing

standard.” Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1366

(Fed. Cir. 2008) (emphasis added) (citing Scanner Techs., 528 F.3d at 1376).

I believe that the “rule” of Scanner Technologies has been breached in this case.

The submissions made by Abbott to the EPO are susceptible of multiple reasonable

inferences and, depending on the inference drawn, may or may not be material. In

each instance, the district court inferred one meaning from the EPO submissions,

rendering them material, when an equally reasonable (if not more reasonable) inference

renders them immaterial.

The district court found that Abbott’s “submissions made to the EPO were

inconsistent with the submissions made to the PTO in at least two important ways.”

Trial Opinion, 565 F. Supp. 2d at 1109. 1 First, in the district court’s words, “The EPO

was told that under the ’382 a protective membrane was merely preferred and not

required when dealing with live blood and specifically quoted the ‘optionally, but

preferably’ sentence in support.” Id. at 1109-10 (emphases in original). Second, “The

EPO was told that the critical sentence was ‘unequivocally clear’ and taught skilled

artisans that ‘the protective membrane [was] optional, however it is preferred when used

on live blood . . . .’” Id. at 1110 (alteration and omission in original).

1 These were the only two ways in which Abbott’s submissions were found to be “inconsistent” and thus material under 37 C.F.R. § 1.56(b)(2). Thus, it is these two findings that must be reviewed for clear error. Although the district court cited the “reasonable examiner” standard and found that Abbott’s EPO submissions would have been “highly material” to such an examiner, the district court made this finding only to the extent that the submissions were “contradictory” or inconsistent. Trial Opinion, 565 F. Supp. 2d at 1110.

2008-1511, -1512, -1513, -1514, -1595 4 In my view, the district court arrived at these two findings in error. I address

these findings in turn.

1. “merely preferred and not required”

The first clearly erroneous finding inappropriately attributes to Abbott statements

that it did not make. Abbott never said that the membrane was “merely preferred” or

“not required” when dealing with blood. Such a statement would be devastating to

Abbott and would clearly be material. Instead, Abbott’s EPO submissions simply

quoted the “[o]ptionally, but preferably” sentence from the ’382/’636 patent and, tracking

closely the just-quoted language, stated that the protective membrane is “preferably to

be used with in vivo measurements” and is “preferred when used on live blood.” J.A.

6531, 6585. The word “preferably” is the very same word used in the ’382/’636 patent.

Abbott never said “merely preferred,” and it certainly never said “not required.” Nor did

Abbott ever use any synonym that might have shed some light on the meaning of the

word as used in the patent. Instead, Abbott used the very same word (preferably) in the

very same context (blood) as the word appears in the ’382/’636 patent. Because

Abbott’s submissions to the EPO tracked the very language of the ’382/’636 patent, they

add nothing to the meaning of the word “preferably” beyond what was already before

the examiner in the ’382/’636 patent. 2

2 See Trial Tr. 647, Jun. 2, 2008 (Attorney Pope testifying that the EPO submissions were “redundant of information already before the examiner” because “[t]hat quote appears precisely in the ’382 patent”), 653 (“[T]hey paraphrased the quote that they use, and in so doing, they picked up the language ‘preferable.’ That was, in my mind, simply because they were tracking the quote . . . .”); 677 (“I understand they used the word ‘preferred’ in their argumentation because they were simply tracking and paraphrasing the quote that they were discussing.”).

2008-1511, -1512, -1513, -1514, -1595 5 If anything, the EPO submissions bolster, rather than refute, Abbott’s argument

to the PTO that a protective membrane was thought by persons of ordinary skill to be

required for use in blood. One of the EPO submissions explains that the protective

membrane serves to “prevent the larger constituents of the blood, in particular

erythrocytes, from interfering with the electrode sensor.” J.A. 6585. Indeed, it is this

very function that makes it a “protective” membrane: the membrane protects the

electrodes from fouling caused by the larger constituents found in blood. 3 The EPO

Board itself, upon reviewing Abbott’s submissions, recognized as much when it held:

“The Board can therefore agree with the Appellant that by a protective membrane is

meant exercising a filtering function, preventing the grosser components of blood from

reaching the electrode . . . .” J.A. 6570-71. Given that the Board itself recognized that

the protective membrane serves an important “filtering function” in blood, it cannot be

said that Abbott’s EPO submissions somehow denigrated the role of a protective

membrane when used on blood. 4

It is important to appreciate that, aside from testing on “blood,” the sensor recited

in claim 1 of the ’636 patent is also claimed for testing on “interstitial fluid.” Interstitial

fluid does not contain those larger constituents in blood that cause fouling of the

sensor’s electrodes. Because the larger constituents are absent in interstitial fluid, all

parties agree that a protective membrane is optional when the sensor is used to test

3 See Trial Tr. 676 (Attorney Pope testifying that the ’382/’636 patent “doesn’t give any reason why it says ‘preferably when being used on live blood,’ whereas, when we look down to the sentence [in the EPO submission], they give a reason why you want the protective membrane.”). 4 See Trial Tr. 647 (Attorney Pope testifying that “[t]he decision at the [EPO] Technical Board of Appeals was entirely consistent with my understanding at the time” that “preferably” meant “required”).

2008-1511, -1512, -1513, -1514, -1595 6 interstitial fluid. 5 It is therefore reasonable to interpret the word “optionally,” in the

phrase “[o]ptionally, but preferably when used on live blood,” as governing those

situations in which the fluid being tested is something other than blood, such as

interstitial fluid. 6

Abbott’s submissions to the EPO do not contradict this interpretation. Abbott

never said that the membrane is optional all the time, in all fluids, or under all

conditions. Rather, Abbott said that the membrane is “optionally utilized with the

glucose sensor of the patent in suit,” J.A. 6530-31 (emphasis added), more specifically,

“claim 1 of the patent in suit,” J.A. 6530 (emphasis added). Claim 1 of this patent

recites, in the disjunctive, “blood or interstitial fluid.” No claim is directed to blood

alone. 7 Abbott’s EPO submissions can therefore be interpreted, consistent with the

quoted “[o]ptionally, but preferably” sentence, to mean that a protective membrane is

used “preferably” on blood, and “optionally” on fluids other than blood, such as

interstitial fluid. And again, the word “preferably” is not defined in the EPO submissions

or otherwise explained, except to say that the membrane serves to “prevent the larger

constituents of the blood, in particular erythrocytes, from interfering with the electrode

5 See Trial Tr. 674 (Attorney Pope testifying: “The protective membrane was definitely optional. It depended -- the option depended on what was being analyzed.”). 6 See Trial Tr. 690 (Attorney Pope testifying: “My understanding was it was optional for any fluid other than blood.”); Trial Opinion, 565 F. Supp. 2d at 1100 (Abbott’s Proposed Finding No. 90: “the ‘preferably’ language means that the membrane is optional when an in vivo sensor does not contact whole blood but that the membrane is required when the sensor contacts red blood cells [i.e., erythrocytes] in whole blood.”). 7 See Trial Tr. 661-62 (Attorney Pope testifying that “the claims encompassed a sensor that could be used on a variety of analytes. So the claim scope didn’t speak to th[e] issue” of whether a membraneless sensor could be used in blood).

2008-1511, -1512, -1513, -1514, -1595 7 sensor”—a statement that tends to support, rather than refute, Abbott’s argument to the

PTO. J.A. 6585.

But instead of giving Abbott the benefit of a reasonable favorable interpretation,

in which the words “optionally” and “preferably” are directed to interstitial fluid and blood,

respectively; the district court drew a negative inference by extending the word

“optionally” to govern both interstitial fluid and blood, collectively. In this way, the district

court inferred from Abbott’s EPO submissions that a membrane was “not required when

dealing with live blood”—language that Abbott itself never used in its submissions. Trial

Opinion, 565 F. Supp. 2d at 1109 (emphasis in original). By adopting one inference

(i.e., “optionally” governs both blood and interstitial fluid) over an equally reasonable

favorable inference (i.e., “optionally” governs interstitial fluid, and “preferably” governs

blood), the district court, in my view, clearly erred.

2. “unequivocally clear”

The second clearly erroneous finding concerns Abbott’s submission to the EPO

that “[i]t is submitted that this disclosure is unequivocally clear.” J.A. 6585. The district

court found this statement to be inconsistent with Abbott’s argument to the PTO that the

word “preferably,” as used in the patent’s “[o]ptionally, but preferably” sentence, was not

being used in a colloquial sense (to express a mere preference) but rather constituted

“patent phraseology” (to express a requirement). Because Abbott had told the EPO that

“this disclose is unequivocally clear,” 8 the district court inferred from this submission that

8 The full paragraph of the EPO submission dated May 23, 1995 reads: It is submitted that this disclosure is unequivocally clear. The protective membrane is optional, however, it is preferred when used on live blood in order to prevent the larger constituents of the blood, in particular erythrocytes from interfering with the electrode sensor. Furthermore it is

2008-1511, -1512, -1513, -1514, -1595 8 that each and every word of the “[o]ptionally, but preferably” sentence must carry its

plain and ordinary meaning.

While plausible, the district court’s inference is not the only inference that can

reasonably be drawn from Abbott’s submission. Abbott did not say that any specific

word is unequivocally clear. Rather, what was said to be unambiguously clear is “this

disclosure”—i.e., the full quoted sentence from the ’382/’636 patent, which reads:

Optionally, but preferably when being used on live blood, a protective membrane surrounds both the enzyme and the mediator layers, permeable to water and glucose molecules.

This sentence sets forth two functional characteristics of the membrane: (1) it is

“protective,” and (2) it is “permeable to water and glucose molecules.” It is these two

functional characteristics that Abbott, in its argument, went on to describe immediately

after calling this disclosure “unequivocally clear.” 9 First, with regard to the membrane

said, that said protective membrane should not prevent the glucose molecules from penetration, the membrane is “permeable” to glucose molecules. This teaches the skilled artisan that, whereas the semipermeable membrane of D1 must be constructed, for example by crosslinking, in such a way that the membrane will in fact control the permeability of the glucose at the required low value, the purpose of the protective membrane in the patent in suit is not to control the permeation of the glucose molecules. For this very reason the sensor electrode as claimed does not have (and must not have) a semipermeable membrane in the sense of D1. The fact that the same material (cellulose acetate) may be used both for the semipermeable membrane of D1 and the protective membrane of the patent in suit is not relevant. The decisive feature is the modification (crosslinking) of said material to an extent so as to control the permeation of the substrate glucose. Finding the semipermeable membranes satisfying the requirements set forth on page 3, lines 24 to 56 of D1 is tedious and involves considerable trial and error work. Reproducability [sic] of such membranes is always a critical factor. J.A. 6585-86 (emphases in original). 9 See Trial Tr. 672 (Attorney Pope testifying that the “unequivocally clear” statement is directed to “the nature of the membrane”; “And in my understanding, I

2008-1511, -1512, -1513, -1514, -1595 9 being “protective,” Abbott told the EPO that its membrane serves “to prevent the larger

constituents of the blood, in particular erythrocytes from interfering with the electrode

sensor.” J.A. 6585. Second—or in Abbott’s words “[f]urthermore” 10 —the membrane is

“permeable” to glucose molecules because it “should not prevent the glucose molecules

from penetration.” J.A. 6585. These two concepts, as articulated in Abbott’s

submission, flow directly from the quoted sentence of the ’382/’636 patent, in the same

order that they appear in that sentence. It is reasonable to read Abbott’s argument as

saying no more than what is “unambiguously clear,” in the quoted sentence, is that the

membrane serves the dual roles of preventing larger constituents in blood from

interfering with the electrode sensor, while also allowing smaller water and glucose

molecules to pass through.

The district court believed that only this second function, glucose permeability,

was necessary to distinguish the D1 reference in the EPO proceeding, and that Abbott’s

argument to the EPO “plainly went beyond this point of distinction and submitted that it

was ‘unequivocally clear’ that the ’382/’636 needed no membrane at all for use with

blood.” Trial Opinion, 565 F. Supp. 2d at 1116. But Abbott never told the EPO that the

’382/’636 patent “needed no membrane at all for use with blood.” Those are the district

court’s words, not Abbott’s. Moreover, the fact that the ’382/’636 patent can optionally

believed that the reason the entire quote appears [in the EPO submission] is that is the only clear disclosure in the ’382 patent or the ’636 patent with regard to the nature of the protective membrane”; “There isn’t another sentence, another clear disclosure in the ’636 patent that talks about the nature of the protective membrane.” (emphases added)). 10 See Trial Tr. 658 (Attorney Pope testifying: “I would disagree with the fact that the mere use of the word ‘furthermore’ means that it’s a second argument,” rather than “simply being a transitional word.”).

2008-1511, -1512, -1513, -1514, -1595 10 be used with or without a “protective” membrane in some glucose-containing fluids, like

interstitial fluid, was indeed an important point of distinction that ultimately convinced the

EPO Board that the ’382/’636 patent did not possess a “diffusion-limiting” membrane

like that of the D1 reference. 11 The D1 reference requires a diffusion-limiting membrane

because its sensor cannot handle a rapid influx of glucose molecules. The pores of this

membrane are small enough to partially reduce the flow of glucose molecules and to

completely block the much larger blood constituents, like erythrocytes. The ’382/’636

patent, by contrast, has no problem with a rapid influx of glucose molecules, so it does

not need a diffusion-limiting membrane, only a protective membrane to protect against

fouling by larger blood constituents. But the fact that the ’382/’636 patent even

discloses the use of a protective membrane shows that no diffusion-limiting membrane

was present in the ’382/’636 patent. If it were present, then the diffusion-limiting

membrane would itself block larger blood constituents, thus rendering a protective

membrane entirely redundant and unnecessary. The EPO Board understood this exact

point, stating: “Common sense dictates moreover that the optional presence of a

protective membrane would be unnecessary if a diffusion controlling membrane was

present.” J.A. 6571. In other words, the presence of a protective membrane, which

performs the erythrocyte-filtering function of a diffusion-limiting membrane, implies the

absence of a diffusion-limiting membrane. The EPO Board therefore agreed with

Abbott that the ’382/’636 patent did not possess a diffusion-limiting membrane like the

one in the D1 reference, which was precisely the point Abbott was trying to make.

11 See Pl.-Appellants’ Reply Br. 13 (“Thus, by showing that the ’382/’636 did not use a membrane for at least some fluid, MediSense proved that it did not use the D1’s glucose-controlling membranes.”).

2008-1511, -1512, -1513, -1514, -1595 11 By adopting one inference (i.e., what is “unambiguously clear” is the meaning of

each individual word) over an equally reasonable favorable inference (i.e., what is

“unambiguously clear” is the functional role of the membrane), the district court again, in

my view, clearly erred.

The foregoing interpretation of the ambiguous language in Abbott’s EPO

submission is, in my view, at least as reasonable as the district court’s and the

majority’s. This favorable interpretation, unlike the contrary interpretation, does not rely

on individual words or phrases in isolation, but properly views them in context: looking

to the surrounding text in which those words and phrases appear, with an eye towards

the purpose for which the arguments were submitted during prosecution, and is

ultimately consistent with the way the arguments were interpreted by the EPO Board.

As shown with regard to each substantive point in the foregoing materiality analysis,

and with all due respect to my colleagues in the majority, this favorable interpretation

was not invented on appeal; each point was argued to the district court.

The majority concludes that Abbott’s EPO statements “cannot possibly be read in

this manner,” because the “unequivocally clear” statement is “tied directly to the optional

nature of the membrane.” Maj. Op. 24-25. For this proposition, the majority focuses on

the “three sentences in question” in the EPO submission: (1) the “[o]ptionally, but

preferably” sentence quoted from the ’382/’636 patent; (2) the first sentence of a nine-

sentence paragraph that reads, “It is submitted that this disclosure is unequivocally

clear”; and (3) the second sentence of this paragraph that reads, “The protective

membrane is optional, however, it is preferred when used on live blood in order to

2008-1511, -1512, -1513, -1514, -1595 12 prevent the larger constituents of the blood, in particular erythrocytes from interfering

with the electrode sensor.” There are seven more sentences in this paragraph,

overlooked by the majority, that are dedicated to describing the glucose-permeability

function of the membrane. See supra note 8. As previously discussed, it is reasonable

to read this full paragraph as saying that what is “unambiguously clear” (first sentence)

is that the protective membrane performs the dual functions of filtering erythrocytes in

blood (second sentence) while allowing glucose to pass through (third through ninth

sentences).

Instead of reading the paragraph as a whole, the majority links the paragraph’s

topic sentence (“unambiguously clear”) only to the first five words of the second

sentence (“The protective membrane is optional . . . .”). The majority then ascribes the

word “optional” to whole blood and the word “preferred” to live blood. It then

concludes—“[n]ecessarily”—that “the membrane was not required for either whole blood

or live blood.” Maj. Op. 25. Each of these three logical steps is based on inference,

and at each step, I believe the majority has inappropriately drawn an inference against

the patentee.

First, the phrase “[t]he protective membrane is optional” says nothing of blood.

As a general statement, moreover, it is factually correct: the membrane is optional in

certain fluids, like interstitial fluid, which do not contain erythrocytes. As previously

discussed, the fact that the protective membrane is optional in some glucose-containing

fluids, like interstitial fluid, shows that the ’382/’636 patent does not possess a diffusion-

limiting membrane like the one in the D1 reference. The majority entirely misses this

point.

2008-1511, -1512, -1513, -1514, -1595 13 Second, live blood is a species of whole blood; both contain all of the larger

constituents of blood, including erythrocytes. Because both live and whole blood

contain erythrocytes, the latter half of the second sentence describing the membrane’s

filtering function—i.e., “in order to prevent the larger constituents of the blood, in

particular erythrocytes from interfering with the electrode sensor”—applies equally to

both types of blood. The majority, however, distinguishes whole blood from live blood

and places the former into the “optional” category while retaining the latter under the

“preferred” category. But nothing in this paragraph suggests any distinction between

whole and live blood, as both contain erythrocytes. Moreover, to the extent that the

majority relies on such a distinction for purposes of materiality, it fatally undermines the

finding of deceptive intent: Attorney Pope testified that he considered the terms “whole

blood” and “live blood” to be synonymous. Trial Tr. 629. The district court made no

finding that Attorney Pope did not actually possess this belief, or even that this belief

was unreasonable. Instead, the district court dismissed Attorney Pope’s mistaken belief

because “th[e] EPO submissions represented that a membrane was merely optional

when used with blood.” Trial Opinion, 565 F. Supp. 2d at 1114 (emphases added).

This statement lumps together both live and whole blood under the “optional” category.

The majority, however, relies on this distinction and ascribes the word “optional” to

whole blood and the word “preferred” to live blood. Maj. Op. 25 (“[T]he membrane was

optional (whole blood and other fluids) or preferred (live blood).” (emphases added)).

Because the majority relies on this distinction for purposes of materiality, Attorney

Pope’s honest but mistaken belief would serve as additional exculpatory evidence under

the intent prong.

2008-1511, -1512, -1513, -1514, -1595 14 Third, the majority concludes that, irrespective of whether the membrane was

“optional” or “preferable” in either whole or live blood, it “[n]ecessarily” follows that the

membrane was “not required for either whole blood or live blood.” Id. (emphases

added). It is unclear how the majority arrives at this conclusion. The question here is

not what the word “preferably” means in isolation but whether anything in Abbott’s EPO

submissions, which quotes and tracks the very language in the ’382/’636 patent,

contradicts Abbott’s argument to the PTO. And again, Abbott never told the EPO that

the membrane is “not required” for use in blood; nor did it use any synonym for the word

“preferred.” Because the EPO submissions explain that the membrane serves to

protect the sensor from erythrocytes found in whole blood, these submissions tend to

bolster rather than refute Abbott’s arguments to the PTO.

A final point deserves brief comment. The majority invokes the familiar adage

that “[c]lose cases should be resolved by disclosure.” LaBounty Mfg., Inc. v. U.S. Int’l

Trade Comm’n, 958 F.2d 1066, 1076 (Fed. Cir. 1992) (emphasis added). It is sage

advice, and practitioners should take it to heart, so that they may avoid even being

accused of inequitable conduct, much less being found to have committed it. But this

adage is not a legal rule. We have never recognized a “close case” standard for

materiality. The majority, however, believes that if this is such a case, then the duty of

disclosure “requires that the material in question be submitted to the examiner.” Maj.

Op. 26 (emphasis added). Our circuit already entertains five different standards for

materiality. See Digital Control, Inc. v. Charles Mach. Works, 437 F.3d 1309, 1315-16

(Fed. Cir. 2006). I do not think that we need a sixth.

2008-1511, -1512, -1513, -1514, -1595 15 B. Intent

“[I]nequitable conduct requires not intent to withhold, but rather intent to deceive.”

Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1367 (Fed. Cir. 2003).

The requisite level of intent is “specific intent”—not simple negligence, or even gross

negligence. Star Scientific, 537 F.3d at 1368; Kingsdown Med. Consultants, Ltd. v.

Hollister Inc., 863 F.2d 867, 876 (Fed. Cir. 1988) (en banc) (holding even gross

negligence insufficient to prove intent to deceive). As recognized by the Supreme Court

and virtually every circuit, “specific intent” denotes a subjective rather than objective

standard and is generally associated with actions deliberately and consciously taken to

achieve a specific result. 12

Consistent with this subjective standard, “[i]ntent to deceive cannot be inferred

simply from the decision to withhold the reference where the reasons given for the

withholding are plausible.” Dayco, 329 F.3d at 1367 (emphases added). One “reason”

that a reference may legitimately be withheld is that the “applicant did not know of its

materiality.” FMC Corp. v. Manitowoc Co., 835 F.2d 1411, 1415 (Fed. Cir. 1987)

(emphasis added). It is this lack of knowledge, or one’s subjective belief that the

reference was immaterial, that a court must assess as either plausible or implausible for

purposes of specific intent. Thus, when assessing an applicant’s reason for withholding

a reference that he or she believed was immaterial, the question is not, “Is it plausible

12 Hartzel v. United States, 322 U.S. 680, 686 (1944); United States v. Philip Morris USA Inc., 566 F.3d 1095, 1118 (D.C. Cir. 2009); Pierre v. Attorney Gen., 528 F.3d 180, 189 (3d Cir. 2008); United States v. Nguyen, 493 F.3d 613, 624 (5th Cir. 2007); United States v. Zunie, 444 F.3d 1230, 1234 (10th Cir. 2006); United States v. Puckett, 405 F.3d 589, 596 (7th Cir. 2005); United States v. George, 386 F.3d 383, 390 (2d Cir. 2004); United States v. De Leon, 270 F.3d 90, 92 (1st Cir. 2001); United States v. Gracidas-Ulibarry, 231 F.3d 1188, 1196 (9th Cir. 2000).

2008-1511, -1512, -1513, -1514, -1595 16 that the reference is immaterial?” That question belongs under the objective materiality

prong, to be evaluated “on the evidence as informed by the range of reasonable

inferences” both for and against materiality. Scanner Techs., 528 F.3d at 1376. Rather,

the question for purposes of specific intent is, “Is it plausible that the applicant

subjectively believed that the reference was immaterial?” This inquiry properly focuses

on what the applicant knew or believed to be true about the reference at the time that he

or she decided to withhold it.

In this case, it is significant that Attorney Pope and Dr. Sanghera were not aware

of what the district court called the “one exception” in the prior art—U.S. Patent No.

4,388,166 (“Suzuki”)—of a membraneless sensor used on whole blood. Trial Opinion,

565 F. Supp. 2d at 1099 & n.6, 1106 n.12. If they had known of Suzuki, it would have

significantly undercut their argument to the PTO that persons of ordinary skill believed

that membranes were required for use on whole blood. Moreover, if they had known of

Suzuki, it would have made it far more difficult for them to explain why they interpreted

the EPO submissions in a manner contrary to Suzuki. But, unlike Suzuki, all prior art of

record and all prior art of which Attorney Pope and Dr. Sanghera were aware uniformly

showed that “those skilled in the art typically employed a membrane on a sensor used

with live or whole blood.” Id. at 1099. It is therefore entirely plausible that Attorney

Pope and Dr. Sanghera subjectively believed that the EPO discussion of the ’382/’636

patent—just like all other prior information known to them—did not contradict the use of

membranes for testing on whole blood.

Nor did Attorney Pope or Dr. Sanghera have any knowledge that one of the

inventors, Dr. Higgins, held a contrary view of the “[o]ptionally, but preferably” language.

2008-1511, -1512, -1513, -1514, -1595 17 Attorney Pope did not draft the original specification, and the two did not discuss this

language with Dr. Higgins when they submitted their argument to the PTO. As we have

made clear, “no duty to inquire arises unless counsel is on notice of the likelihood that

specific, relevant, material information exists and should be disclosed.” Brasseler,

U.S.A. I, L.P. v. Stryker Sales Corp., 267 F.3d 1370, 1383 (Fed. Cir. 2001) (emphases

added). “The mere possibility that material information may exist will not suffice to give

rise to a duty to inquire.” Id. at 1382 (emphasis added). Here, the record does not

show, and no party has argued, that Attorney Pope and Dr. Sanghera were on notice, at

the time of the withholding, of the likelihood that Dr. Higgins held a different view of the

“[o]ptionally, but preferably” language. To the contrary, it appears that Dr. Higgins

formulated his opinion of this particular language for the first time in the present

litigation. Dr. Higgins’s personal opinion is therefore entirely irrelevant to what Attorney

Pope and Dr. Sanghera subjectively believed at the time of the withholding.

Nor is there any dispute that Dr. Sanghera was perfectly qualified to submit an

expert declaration to the PTO as to the meaning of the “[o]ptionally, but preferably”

language. As the district court found, “a person of ordinary skill in the art would have

had a doctoral degree or postgraduate experience working toward a Ph.D” and “would

also have had some level of experience in actually constructing electrochemical sensors

or would at least be familiar with them.” Trial Opinion, 565 F. Supp. 2d at 1100 n.8. Dr.

Sanghera had earned a Ph.D in Electrochemical Biosensors and had worked in the

research and development of biosensors for over ten years by the time he submitted his

declaration to the PTO in 1997. J.A. 7636. Although he did not possess these

qualifications in 1983 (the invention date of the ’551 patent), this fact would not

2008-1511, -1512, -1513, -1514, -1595 18 disqualify him from giving a competent opinion in 1995 as to what a hypothetical person

of ordinary skill would have known in 1983. See Endress + Hauser, Inc. v. Hawk

Measurement Sys. Pty. Ltd., 122 F.3d 1040, 1042 (Fed. Cir. 1997) (stating that the

“person of ordinary skill in the art” in § 103 is a “theoretical construct . . . and is not

descriptive of some particular individual”). In his declaration, Dr. Sanghera fully

disclosed his qualifications and his employment with the assignee, Medisense (now

Abbott). J.A. 7636. He also testified that he had thoroughly searched the prior art for

any information that might contradict his declaration. Trial Tr. 709-10. There is no

suggestion, much less any finding by the district court, that Dr. Sanghera did not

actually perform this search or that it was not made in good faith.

With regard to the foregoing, the majority correctly acknowledges: (1) that it is

“undisputed” that Attorney Pope and Dr. Sanghera were unaware of the existence of

either the Suzuki reference or Dr. Higgins’s contrary interpretation, (2) that the district

court did not base its finding of intent on the existence of such knowledge, and (3) that it

did not find that Dr. Sanghera was unqualified or misrepresented his credentials. Maj.

Op. 32. While calling these facts “irrelevant,” id. 31, the majority nevertheless “finds

support” for the district court’s finding of intent based on these very facts, namely, that

“Pope relied on Dr. Sanghera, who was not a person having ordinary skill in the art at

the time of the ’382 patent, . . . rather than the inventors of the patent, who appear to

have had a view quite contrary to Abbott’s,” id. 30. Indeed, far from being “irrelevant,”

any facts tending to show what Attorney Pope and Dr. Sanghera did or did not know

during prosecution are critical to discerning their intent and the plausibility of their

explanation. All available evidence regarding an individual’s mental state, particularly

2008-1511, -1512, -1513, -1514, -1595 19 facts “point[ing] away from an intent to deceive,” must be weighed when assessing

culpable intent. Akron Polymer Container Corp. v. Exxel Container, Inc., 148 F.3d

1380, 1384 (Fed. Cir. 1998) (stating that “requisite weight . . . must be given” to

evidence of good faith). The fact that these individuals were unaware of any information

that would contradict their argument to the PTO, despite having performed a prior art

search (a search that they had no obligation to perform) for the specific purpose of

ensuring the validity of their argument, is evidence of good faith. But the district court

expressly “found no[]” evidence of good faith and dismissed any “possible inferences of

good faith.” Trial Opinion, 565 F. Supp. 2d. at 1114. It necessarily gave no weight to

any favorable inference.

The district court rejected Attorney Pope’s and Dr. Sanghera’s good faith

explanations as “not plausible” and “unconvincing.” While considerable deference is

owed to a trial court’s credibility determinations, this does not mean that a trial court can

“cloak the application of an erroneous legal standard in the guise of a credibility

determination, and thereby shield it from appellate review.” Andreu v. Sec’y of Dep’t of

Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009). Indeed, on closer

examination, it becomes apparent that the district court simply disagreed with Attorney

Pope’s and Dr. Sanghera’s interpretation of the EPO submissions. The district court’s

opinion reflects that what proved “unconvincing” to the court was not the truthfulness of

the witnesses’ subjective beliefs, but rather the notion that the submissions were not in

fact material.

Attorney Pope testified that he believed the EPO submissions to be cumulative of

the ’382/’636 patent because those submissions quoted and tracked the very same

2008-1511, -1512, -1513, -1514, -1595 20 “[o]ptionally, but preferably” language in the ’382/’636 patent, and that the word

“preferably,” read in context of the entire ’382/’636 patent, meant that the protective

membrane was required in whole blood. Trial Tr. 640-41, 643, 645-47. As a patent

attorney with over thirty years of professional experience, Attorney Pope testified that,

when drafting and prosecuting applications, practitioners often use the word “preferred”

rather than “required” in order to avoid a disclaimer of claim scope. Trial Tr. 632

(testifying that “[i]f the specification says ‘you must,’ then you’ve now precluded yourself

from ever claiming more broadly”). See, e.g., Andersen Corp. v. Fiber Composites,

LLC, 474 F.3d 1361, 1372 (Fed. Cir. 2007) (construing product claim as product-by-

process claim because the specification used “language of requirement, not preference”

(emphases added)); Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1385 (Fed. Cir. 2005)

(construing claim to require unrecited feature where applicant told examiner that such

feature “must be used” (emphasis added)). In his view, the earlier EPO submissions did

not contradict his argument to the PTO regarding the meaning of the word “preferably,”

because those submissions themselves explain why a membrane is “preferred” (i.e.,

“required”) in whole blood: “to prevent the larger constituents of the blood, in particular

erythrocytes from interfering with the electrode sensor.” Trial Tr. 676-77 (quoting May

23, 1995 EPO submission). Thus, Attorney Pope believed that the EPO submissions

were not material because they were both cumulative of the ’382/’636 patent and not

inconsistent with the PTO submissions.

This explanation is not conclusory. It relies on specific statements and

information in the references, and it specifically provides that this was the reason why,

at the time, the information was not disclosed to the PTO. Such an explanation is a far

2008-1511, -1512, -1513, -1514, -1595 21 cry from a “mere denial of intent to mislead (which would defeat every effort to establish

inequitable conduct).” FMC Corp., 835 F.2d at 1416. Compare Praxair, Inc. v. ATMI,

Inc., 543 F.3d 1306, 1317-18 (Fed. Cir. 2008) (affirming finding of deceptive intent

where attorney’s explanation failed to “suggest that, at the time of the prosecution of the

’115 patent, he believed that disclosure of the RFO art would have been cumulative; he

also does not actually state that the alleged cumulativeness was the reason he failed to

disclose prior art RFO devices to the PTO; and he was unable to identify any specific

reference that rendered the RFOs cumulative” (emphases added)), with In re Harita,

847 F.2d 801, 806-07 (Fed. Cir. 1988) (reversing finding of deceptive intent where

Japanese patent agent explained that he believed, at the time, there was no duty to

disclose to the PTO prior art discovered after filing, as was the practice in Japan).

“Intent to deceive should be determined in light of the realities of patent practice,

and not as a matter of strict liability whatever the nature of the action before the PTO.”

N. Telecom, Inc. v. Datapoint Corp., 908 F.2d 931, 939 (Fed. Cir. 1990). Here, the trial

court’s disagreement with Attorney Pope centered not on his subjective understanding

of the facts but rather on the court’s normative view of the law. First, in dismissing his

explanation that the word “preferably” in the context of the ’382/’636 patent means

“required,” the district court stated, “Words are supposed to mean what they say.

Otherwise, our patent-disclosure system would collapse.” Trial Opinion, 565 F. Supp.

2d. at 1114. But we have long recognized that “patentees frequently use terms

idiosyncratically,” which is why persons of ordinary skill must look to the full context in

which a term is used. Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en

banc). The district court’s second reason for dismissing Attorney Pope’s explanation

2008-1511, -1512, -1513, -1514, -1595 22 was that, “since the claims of the ’382 covered membraneless sensors used in blood, as

both sides agree, the specification must have been sufficient to support the

membraneless sensors.” Trial Opinion, 565 F. Supp. 2d. at 1114 (emphases in

original). I find this reasoning flawed. It presupposes that the specification of the ’382

patent enabled such a “membraneless sensor[] for use in blood”—a fact that Abbott

fiercely disputes. See Br. of Pl.-Appellant 14-15. Moreover, it relates to a product that

is not specifically claimed in the ’382 patent. See ’382 patent cl.1 (claiming “[a] sensor

electrode for use in a liquid mixture of components”—not specifically blood (emphasis

added)). The district court concluded, “At all events, . . . the fact remains that ‘preferred’

does not mean ‘required,’ which was a point made in the EPO appeal.” Trial Opinion,

565 F. Supp. 2d. at 1114. This statement is circular, and it again shows that the district

court anchored its assessment of Attorney Pope’s subjective beliefs to the court’s

previous finding of objective materiality. 13

The majority does not deny that the district court found the individuals’ good faith

explanations “not plausible” and “not credible” in light of its prior finding of objective

materiality. Moreover, the majority itself rejects these good faith explanations based on

the very same “plain English” rationale on which it affirms the materiality finding.

Compare Maj. Op. 25-26 (affirming materiality based on “plain English reading” of

isolated words), with id. 29-30 (rejecting good faith explanation because it contradicts

“normal English” meaning of isolated words). 14 Respectfully, this rationale misses the

13 The majority states that the district court found the individuals’ explanations “so incredible that they suggested intent to deceive.” Maj. Op. 28. A review of the district court’s opinion reveals no such finding. 14 By assessing the “plausibility” or “credibility” of an individual’s good faith explanation in light of the objectively defined materiality of the withheld information, the

2008-1511, -1512, -1513, -1514, -1595 23 point as it relates to the question of intent. Attorney Pope testified that he read the

“[o]ptionally, but preferably” language, not in isolation, but “in the context of the entire

document,” and that he “would never attempt to understand something drawn out of a

document standing alone.” Trial Tr. 668. That Attorney Pope actually read these words

in context, rather than in isolation, has not been disputed. The isolated “plain English”

meaning of those words, therefore, has little bearing on the plausibility of his subjective

belief regarding his understanding of the EPO submissions.

In my view, Attorney Pope and Dr. Sanghera’s good faith explanations are

entirely consistent with the alternative reasonable interpretation of the EPO submissions

that renders them immaterial. Indeed, as demonstrated by the myriad footnote citations

to the trial record, supra, this alternative reasonable interpretation is the one that the

individuals’ themselves presented to the district court. Coupled with the fact that these

individuals were unaware of the Suzuki patent (or any other contrary teachings), their

explanations are certainly plausible.

It bears repeating that what is “plausible” here, for purposes of specific intent, is

that the individuals subjectively believed that the withheld information was immaterial

when they withheld it. This answers a different question than the one the district court

appeared to ask, which was whether it is plausible that the withheld information was not

in fact material—a test more appropriately considered under the objective materiality

majority has, either wittingly or not, tied all three of the Ferring factors to a prior finding of materiality. See Praxair, 543 F.3d at 1313-14 (permitting an inference of deceptive intent to be drawn “when (1) highly material information is withheld; (2) ‘the applicant knew of the information [and] . . . knew or should have known of the materiality of the information; and (3) the applicant has not provided a credible explanation for the withholding.’” (quoting Ferring B.V. v. Barr Labs., Inc., 437 F.3d 1181, 1191 (Fed. Cir. 2006) (emphases added))).

2008-1511, -1512, -1513, -1514, -1595 24 prong. To the extent that the district court assessed the plausibility of the individuals’

subjective beliefs based on the objective reasonableness of those beliefs, or otherwise

required their mistake to be reasonable in order to defeat a finding of specific intent, it

did so in violation of Kingsdown, 863 F.2d at 876 (holding even gross negligence

insufficient to prove intent to deceive).

Because I am left with a definite and firm conviction that a mistake has been

committed with respect to both materiality and intent, I would reverse the district court’s

inequitable conduct ruling.

II. Invalidity

I agree with the majority that the prior art ’382 patent renders the claims of the

’551 patent obvious (Part I of majority opinion) and that the prior art ’225 patent

anticipates the claims of the ’745 patent (Part IV of majority opinion). The descriptive

portions of the prior art patents are alone sufficient to invalidate the claims-in-suit. It is

therefore unnecessary, and I believe improper in this case, to look to the claims of the

prior art patents as a measure of what the prior art discloses for purposes of

obviousness and anticipation. See In re Benno, 768 F.2d 1340, 1346 (Fed. Cir. 1985)

(“The scope of a patent’s claims determines what infringes the patent; it is no measure

of what it discloses.”). Here, although the claims of the prior art ’382 and ’225 patents

are broad enough to cover a membraneless sensor and a diffusible redox mediator,

respectively, those structures are not specifically recited in the claims but instead are

disclosed in the descriptive portions of the specification.

2008-1511, -1512, -1513, -1514, -1595 25 The majority quotes Brenno as follows: “[I]t is true . . . that ‘a claim is part of the

disclosure’ . . . .” Maj. Op. 7. But the internal quotation is attributed to the PTO Solicitor

and overlooks the more relevant statements made by the court immediately before and

after it. The court’s full quotation reads:

Samuel F.B. Morse, the inventor of the telegraph, had a patent thereon, issued in 1840, containing a claim (which the Supreme Court held invalid) which was broad enough to read on the modern Telex. By the board’s reasoning, Morse’s telegraph patent therefore would have made the Telex obvious. The scope of a patent’s claims determines what infringes the patent; it is no measure of what it discloses. A patent discloses only that which it describes, whether specifically or in general terms, so as to convey intelligence to one capable of understanding. While it is true, as the Solicitor suggested at oral argument, that “a claim is part of the disclosure,” that point is of significance principally in the situation where a patent application as filed contains a claim which specifically discloses something not disclosed in the descriptive part of the specification (claims being technically part of the “specification,” 35 USC 112, 2d par.), in which case the applicant may amend the specification without being charged with adding “new matter,” within the meaning of § 132. But that is not the situation here. Danti’s claim 1 does not disclose any structure additional to what the Danti specification discloses.

Benno, 768 F.2d at 1346 (emphases added; internal citations omitted). The court went

on to reverse the Board’s rejections over the prior art Danti patent.

Here, the claims of the ’382 and ’225 patents do not specifically disclose a

membraneless sensor or a diffusible redox mediator; those structures are instead

disclosed in the descriptive parts of the specifications. It is also unclear whether the

claims on which the majority relies were originally present in the applications that

resulted in the ’382 and ’225 patents or whether they were added during prosecution,

which may affect their prior art date.

2008-1511, -1512, -1513, -1514, -1595 26 The other cases cited by the majority to justify its reference to the claims of the

prior art patents are not on point. In In re Smolak, 88 F.2d 838, 840 (CCPA 1937), it

was appropriate to look to the claims of a reference patent for a disclosure of a “press

molded” limitation because, “[t]he words ‘press molded’ appear only in the claims of the

reference.” In Gabrielidis v. Prince Sports Group, Inc., 2000 WL 1648134, at *7 (Fed.

Cir. Nov. 1, 2000) (nonprecedential), we held that certain elements were not disclosed

anywhere in the reference patent, either in the claims or in the remainder of the

specification, and therefore affirmed the denial of summary judgment of anticipation.

Thus, while I agree with the majority’s conclusion on obviousness and

anticipation and with much of the reasoning in Parts I and IV of the opinion, I part

company with my colleagues in their unnecessary, and in my view improper, reference

to the claims of the prior art patents.

2008-1511, -1512, -1513, -1514, -1595 27