Scott D. Eads, OSB #910400 OSB #160306 Email: … · 2017-03-09 · Sensors,” and disclose...

PLAINTIFF’S OPENING MARKMAN BRIEF SCHWABE, WILLIAMSON & WYATT, P.C.

Attorneys at Law 1211 SW 5th Ave., Suite 1900

Portland, OR 97204 Telephone: 503.222.9981

Fax: 503.796.2900

Scott D. Eads, OSB #910400 Email: [email protected] Nicholas F. Aldrich, Jr., OSB #160306 Email: [email protected] Jason A. Wrubleski, OSB #120524 Email: [email protected] SCHWABE, WILLIAMSON & WYATT, P.C. 1211 SW 5th Ave., Suite 1900 Portland, OR 97204 Telephone: 503.222.9981 Facsimile: 503.796.2900

Attorneys for Plaintiff AgaMatrix, Inc.

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF OREGON

AGAMATRIX, INC., a Delaware corporation,

Plaintiff,

vs. DEXCOM, INC., a Delaware corporation,

Defendant.

Case No. 3:16-cv-00536-MO PLAINTIFF’S OPENING MARKMAN CLAIM CONSTRUCTION BRIEF

HIGHLY CONFIDENTIAL – OUTSIDE ATTORNEYS’ EYES ONLY NOT FOR DISCLOSURE TO ANY PERSON OTHER THAN THOSE DESIGNATED IN PARAGRAPH 8(B) OF THE STIPULATED PROTECTIVE ORDER

Case 3:16-cv-00536-MO Document 56 Filed 11/22/16 Page 1 of 39

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TABLE OF CONTENTS Page

I. BACKGROUND ................................................................................................................ 1

II. AGAMATRIX’S PATENTED INVENTIONS .................................................................. 2

A. AgaMatrix’s “Structurally Flexible” Sensor Wires ................................................ 2

B. AgaMatrix’s “Nubs and Cavity” Sensors ............................................................... 3

C. Dexcom’s Accused CGM Sensors .......................................................................... 5

III. LEGAL STANDARD ......................................................................................................... 6

IV. DISPUTED CLAIM TERMS OF THE ’202 AND ’433 PATENTS ................................. 8

A. “Structurally Flexible Core” ................................................................................... 8

B. The “Surrounding” and “Further Surrounding” Terms ........................................ 10

C. “Said Outer Surface of Said Core” and “A First End of Said Core” .................... 12

D. “Electrochemically Active Metal Prevents Body Fluid from Contacting said Core”.............................................................................................................. 15

V. DISPUTED CLAIM TERMS OF THE ’574 PATENT ................................................... 18

A. The “Electrochemically Active Surface” Terms ................................................... 18

1. “Electrochemically Active Surface” ............................................. 21

2. “Cavity” ........................................................................................ 22

3. “Sensing Region” .......................................................................... 22

4. “Nub Displaced Longitudinally” .................................................. 24

B. “Nubs”................................................................................................................... 25

C. “Surrounding” ....................................................................................................... 30


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TABLE OF AUTHORITIES

Page(s)

Cases

Advanced Steel Recovery, LLC v. X-Body Equip., Inc., 2013 U.S. Dist. LEXIS 128667 (E.D. Cal. Sept. 6, 2013) .......................................................15

Apple Inc. v. Motorola, Inc. 757 F.3d 1286 (Fed. Cir. 2014)................................................................................................20

Applied Med. Res. Corp. v. United States Surgical Corp., 448 F.3d 1324 (Fed. Cir. 2006)................................................................................................23

Atlas IP, LLC v. St. Jude Med., Inc., 804 F.3d 1185 (Fed. Cir. 2015)................................................................................................12

Augme Techs., Inc. v. Yahoo!, Inc., 2012 U.S. Dist. LEXIS 151 (N.D. Cal. Jan. 3, 2012) ................................................................7

Aventis Pharms., Inc. v. Amino Chems. Ltd., 715 F.3d 1363 (Fed. Cir. 2013)................................................................................................14

Biosig Instruments, Inc. v. Nautilus, Inc., 783 F.3d 1374 (Fed. Cir. 2015)................................................................................................25

Board of Trs. of Leland Stanford Jr. Univ. v. Roche Molecular Sys., 528 F. Supp. 2d 967 (N.D. Cal. 2007) .......................................................................................7

Comark Communs., Inc. v. Harris Corp., 156 F.3d 1182 (Fed. Cir. 1998)................................................................................................28

Computer Stores Northwest, Inc. v. Dunwell Tech., Inc., 2011 U.S. Dist. LEXIS 58660 (D. Or. May 31, 2011) ......................................................27, 28

Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358 (Fed. Cir. 2001)................................................................................................11

Eon Corp. IP Holdings LLC v. Silver Spring Networks, Inc., 815 F.3d 1314 (Fed. Cir. 2016)..................................................................................................6

Gart v. Logitech, Inc., 254 F.3d 1334 (Fed. Cir. 2001)................................................................................................28

Imaginal Systematic, LLC v. Leggett & Platt, Inc., 805 F.3d 1102 (Fed. Cir. 2015)................................................................................................20


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Kopykake Enters. v. Lucks Co., 264 F.3d 1377 (Fed. Cir. 2001)..................................................................................................6

Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898 (Fed. Cir. 2004)..................................................................................................11

MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323 (Fed. Cir. 2007)................................................................................................28

Microsoft Corp. v. i4i Ltd. P'ship, 564 U.S. 91 (2011) ...................................................................................................................25

Motorola Mobility, Inc. v. TiVo, Inc., 2012 U.S.Dist. LEXIS 174026 (E.D. Tex. Dec. 5, 2012) ........................................................15

Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. ___, 134 S. Ct. 2120 (2014) ......................................................................................25

Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005)........................................................................................ passim

Sipco LLC v. Toro Co., 2009 U.S. Dist. LEXIS 10312 (E.D. Penn. Feb. 10, 2009) .....................................................15

SunRace Roots Enter. Co. Ltd. v. SRAM Corp., 336 F.3d 1298 (Fed. Cir. 2003)................................................................................................28

Thomas Swan & Co. v. Finisar Corp., 2014 U.S. Dist. LEXIS 86209 (E.D. Tex. June 25, 2014) .......................................................18

Transmatic, Inc. v. Gulton Indus., 53 F.3d 1270 (Fed. Cir. 1995)..................................................................................................11

Trebro Mfg. v. FireFly Equip., LLC, 748 F.3d 1159 (Fed. Cir. 2014)................................................................................................11

United States Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554 (Fed. Cir. 1997)..................................................................................................7

Wilson Sporting Goods Co. v. Hillerich & Bradsby Co., 442 F.3d 1322 (Fed. Cir. 2006)..................................................................................................7

Statutes

35 U.S.C. § 112(b) .........................................................................................................................24

35 U.S.C. § 282 ..............................................................................................................................25


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Other Authorities

Merriam-Webster’s Collegiate Diction 1183 (10th Ed. 2000) ......................................................31

PATENT CASE MANAGEMENT JUDICIAL GUIDE (Federal Judicial Center 2009) ...............................7

Webster’s II New Riverside University Dictionary 806 (1988) .....................................................27


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I. BACKGROUND

This patent case relates to continuous glucose monitoring (CGM) devices. Historically,

diabetes patients have applied blood drawn from a prick of the finger to a single-use test strip to

check their blood glucose levels. If blood glucose levels are too high, the patient injects insulin

to bring them down. However, glucose level measurements are susceptible to errors for a

number of reasons, including latency between food intake and effect. Consequently, CGM

devices have been developed so that people with diabetes are able to continuously monitor their

glucose levels, rather than taking multiple discrete measurements throughout the day.

In the late 1990s and early 2000s, two companies in particular were early participants in

the newly developing CGM sensor industry. Beginning in about 1999, Portland-based iSense

Corporation (“iSense”) began developing a short-term, partially-implantable sensor, which

would feature a housing taped to the skin, with a small sensor wire inserted into the sub-

cutaneous tissue just under the skin. The sensor wire would remain implanted for up to a week,

continuously measuring the patient’s glucose levels. iSense’s device would not require surgery,

and would be self- administered. The sensor wire is only as thick as a few human hairs, and

about an inch long. It works using an electrochemical reaction, which produces an electrical

current that corresponds to the concentration of glucose in the patient’s interstitial body fluid.

iSense filed its original patent application for this “minimally invasive” CGM device in 2003. In

early 2016, plaintiff AgaMatrix, Inc. (“AgaMatrix”) acquired iSense’s assets relating to this

CGM technology, including its pending FDA applications, its patents and a CGM manufacturing

and testing facility in Wilsonville, Oregon.

The other company, defendant Dexcom, Inc. (“Dexcom”) was focused on a different

strategy in these early days of the CGM industry. Dexcom worked on developing a long-term,

surgically implantable sensor from 1999 until about 2004, when it abandoned that unsuccessful

effort and switched to a short-term CGM device of the same general kind that iSense had spent

the previous five years perfecting. In this lawsuit, AgaMatrix accuses Dexcom’s short-term

partially-implantable CGM devices of infringing three AgaMatrix patents covering such devices.


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II. AGAMATRIX’S PATENTED INVENTIONS

A. AgaMatrix’s “Structurally Flexible” Sensor Wires

In this lawsuit, AgaMatrix asserts three patents that protect important early innovations in

CGM sensor technology.1 It was originally thought that CGM sensor wires should be made

entirely of platinum. As AgaMatrix’s patents explain, platinum is electrochemically active and

therefore quite useful in sensing applications. Platinum wire is also flexible enough to bend

easily with bodily movements. However, as a pioneer in the fledgling field of minimally

invasive CGM technology, iSense was the first to discover that platinum lacked the robustness

needed to withstand the repeated flexing that occurs when a sensor wire is inserted into a patient

for a period of days. Platinum wires, as iSense learned, tended to fracture with repeated flexing,

creating a risk that the small wires would break off and migrate through tissue, posing a threat to

sensitive internal organs.

AgaMatrix owns two patents directed to “structurally flexible” sensor wires that possess

the robustness and flexibility needed to withstand the repeated flexing that occurs with extended

use. U.S. Patent No. 7,146,202 (“the ’202 patent”) issued in December 2006. U.S. Patent No.

8,187,433 (“the ’433 patent”) issued in May 2012. Both are entitled “Compound Analyte

Sensors,” and disclose analyte sensors comprising two metals, a robust “core” metal covered by

a thin layer of an electrochemically active metal, such as platinum. These closely-related patents

share virtually identical specifications and claim priority to the same provisional patent

application filed in June 2003.

In one embodiment, the ’202 and ’433 patents claim a sensor wire having a tantalum core

covered by a thin platinum cladding, as illustrated in Figure 1 of the patents, reproduced below,

where feature 24 can be a tantalum core and feature 26 can be a thin layer of platinum cladding:

1 While the claimed “analyte sensors” may be used to detect a variety of analytes, not just glucose, we will refer to the CGM sensors that are a preferred embodiment of the claimed invention. Generally, an “analyte” is a substance or chemical compound that is the target of an analysis. See Expert Declaration of John L. Smith, Ph.D. (“Smith Decl.”) in support of AgaMatrix’s Opening Markman Brief at ¶ 11.


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Notably, in 2012, Dexcom launched its fourth generation (“G4”) CGM sensor that

discontinued the pure platinum wires used in predecessor generations, in favor of the more

robust, bi-metallic “core and cladding” construction described in AgaMatrix’s patents. Dexcom

may have done this in response to continuing problems it was having with breakage of its

platinum wires inside the bodies of its customers, which resulted in at least one warning letter

from the U.S. Food and Drug Administration (“FDA”), and many customer and caregiver

complaints. See Aldrich Decl., Ex. 1 (FDA Warning Letter), and Ex. 2 (adverse event reports).

B. AgaMatrix’s “Nubs and Cavity” Sensors

The claimed analyte sensors also include membrane layers that may perform a variety of

functions. Such membrane layers are depicted, for example, as features 30, 32 and 34 in the

figure above. Taking a CGM sensor as an example, one such membrane layer may include an

enzyme called glucose oxidase that catalyzes a chemical reaction between glucose and oxygen to

produce hydrogen peroxide. See Smith Decl. at ¶ 20. The hydrogen peroxide is then oxidized


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along a section of the electrochemically active metal to generate a measurable electrical current

corresponding to the glucose concentration in the body fluid. Id. at ¶ 53.

iSense experienced a problem in coating the thin sensor wires with the enzyme

membrane necessary for producing the electrical current (and other membranes). The

membranes are applied by dip-coating the sensor wires in viscous liquids, and then heat-curing

the liquid coating, a procedure that often resulted in uneven application of the membranes to the

sensor wires. Among other things, the liquid could flow off of the wire before curing, resulting

in layers of insufficient thickness. A too-thin enzyme layer could result in too little enzymatic

activity such that glucose levels would be under-reported, an unacceptable result where patients’

lives depend upon accurate glucose measurement.

iSenses’s inventors developed a novel method for producing thickened membrane layers.

With reference to the figure2 below, the metal wire (12) is first coated with a plastic insulation

layer. A laser then cuts one or more sections of the plastic away, creating one or more cavities

(20) of exposed metal wire and two or more plastic nubs (14), one nub on each side of each

cavity:

The sensor wire is then dip-coated in a liquid membrane material that is heat-cured to

produce a fixed membrane layer(s) along the sensor wire. It is important that the membranes do

not collapse into the cavity prior to curing. Similar to a suspension bridge, the protruding nubs

on either side of each cavity provide supportive structures that hold the membrane in place prior

to curing. By virtue of this nub support, the membranes take the shape of a “catenary curve” as

they extend across a cavity from one nub to the opposite nub. Aldrich Decl., Ex. 3 (’574 Patent) 2 Figure 1 of the ’574 patent.


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at 2:4-6. This “nubs and cavity” structure helps ensure that a sufficiently thick membrane layer

is retained on the surface of the metal wire so as to produce a robust enzymatic response. Id. at

2:4-10.

The following diagram shows the results of the dip-coating, with membrane (24) in place:

This “nubs and cavity” patent was granted to iSense inventors Larry Jansen, Ken Ward,

and Ellen Anderson as U.S. Patent 7,529,574 (“the ’574 patent”), which issued in May 2009.

C. Dexcom’s Accused CGM Sensors

After iSense’s inventors filed their patent applications, Dexcom abandoned its long-term

implantable sensor project and began to develop a short-term, partially-implantable CGM sensor

similar to the one that iSense had developed. But Dexcom’s first three generations of sensors,

sold from 2006 to 2012, suffered from the same problems identified by iSense years earlier—the

platinum sensor wires broke or fractured inside the users, resulting in multiple customer and

caregiver complaints and at least one warning from the FDA. Aldrich Decl., Exs. 1 and 2.

In 2012, Dexcom launched a new sensor design that overcame its breakage problems by

adopting iSense’s patented sensor design comprising a tantalum core covered by a thin platinum

cladding. Dexcom’s accused CGM products also use AgaMatrix’s patented “nubs and cavity”

design as shown below:


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Aldrich Decl, Ex. 4.

Dexcom now wants the Court to construe multiple claim terms to try to avoid its

infringement of these three AgaMatrix patents. As discussed below, Dexcom’s overly narrow,

litigation-driven constructions are inconsistent with Supreme Court and Federal Circuit

precedent. They also are contradicted by the plain language of the patent claims, the written

description of the patent specifications and their prosecution file histories. AgaMatrix

respectfully submits that its proposed constructions should be adopted.

III. LEGAL STANDARD

“[W]ords of a claim are generally given their ordinary and customary meaning.” Phillips

v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (internal quotations omitted).

“[T]he ordinary and customary meaning of a claim term is the meaning that the term would have

to a person of ordinary skill in the art in question at the time of the invention.” Id. at 1313.

“[T]he person of ordinary skill in the art is deemed to read the claim term not only in the context

of the particular claim in which the disputed term appears, but in the context of the entire patent,

including the specification.” Id. The Federal Circuit has recently reinforced that “[t]he only

meaning that matters in claim construction is the meaning in the context of the patent.” Eon

Corp. IP Holdings LLC v. Silver Spring Networks, Inc., 815 F.3d 1314, 1321 (Fed. Cir. 2016)

(quoting Trs. of Columbia Univ. v. Symantec Corp., 811 F.3d 1359, 1363 (Fed. Cir. 2016)). This

is because “[t]he ordinary meaning of a claim term is not the meaning of the term in the abstract.

Instead, the ordinary meaning of a claim term is its meaning to the ordinary artisan after reading

the entire patent.” Id. at 1320, (quoting Phillips, 415 F.3d at 1312) (quotes omitted). Further,

“[o]rdinary meaning is not something that is determined in a vacuum. To the contrary, a word

describing patented technology takes its definition from the context in which it was used by the

inventor.” Id. (quotations and citations omitted).

Where the intrinsic evidence provided by the patent and its prosecution file history leaves

ambiguity concerning a claim term’s meaning, extrinsic sources of evidence may be considered.

Kopykake Enters. v. Lucks Co., 264 F.3d 1377, 1381 (Fed. Cir. 2001). These may include expert


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testimony, scientific treatises, and dictionary definitions. Phillips, 415 F.3d at 1317. Where

such an ambiguity exists, dictionary definitions can provide credible evidence of the meaning of

disputed claim terms. Id. at 1318.

However, not all claim terms need to be construed.

The Markman decisions do not hold that the trial judge must repeat or restate every claim term in order to comply with the ruling that claim construction is for the court. Claim construction is a matter of resolution of disputed meanings and technical scope, to clarify and when necessary to explain what the patentee covered by the claims, for use in the determination of infringement. It is not an obligatory exercise in redundancy.

United States Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997). See also,

e.g., Board of Trs. of Leland Stanford Jr. Univ. v. Roche Molecular Sys., 528 F. Supp. 2d 967,

976 (N.D. Cal. 2007) (claim term did not need construction which was “neither unfamiliar to the

jury, confusing to the jury, nor affected by the specification or prosecution history”); Augme

Techs., Inc. v. Yahoo!, Inc., 2012 U.S. Dist. LEXIS 151, *84 (N.D. Cal. Jan. 3, 2012) (“[T]he

Court finds no construction is necessary as the jury could understand the words used in the

patent.”)

Finally, the Federal Circuit has held that, to the extent possible, it is both appropriate and

important that the district court understand the litigation positions that may be driving the

parties’ proposed constructions. Wilson Sporting Goods Co. v. Hillerich & Bradsby Co., 442

F.3d 1322, 1326 (Fed. Cir. 2006) (knowledge of the accused infringing product “provides

meaningful context for… claim construction”). Oftentimes, the peculiarities of a party’s

proposed construction may be better understood (and discounted) in light of infringement and

validity issues that may be motivating the suggested construction. Id.; see also PATENT CASE

MANAGEMENT JUDICIAL GUIDE (Federal Judicial Center 2009) at 5-20 (“[K]nowing the context

of the infringement (or validity) dispute gives courts a better sense of whether they even need to

construe a term, or if they can simply let the ‘plain meaning’ of a term speak for itelf.”)


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IV. DISPUTED CLAIM TERMS OF THE ’202 AND ’433 PATENTS3

A. “Structurally Flexible Core”

No. Claim term AgaMatrix Construction Dexcom Construction 1. “structurally flexible

core” ’202 and ’433 Patents (all asserted claims)

A core of a sensor (or sensing element)4 made from a material, such as tantalum or nitinol, that can be repeatedly flexed without breaking or fracturing when inserted into a patient for a period of days

Element that is capable of being bent repeatedly and is not easily broken with little flexure and having sufficient strength to pierce the skin. *Dexcom withdrew this long-standing proposed construction on November 18, 2016, stating that it disagreed with AgaMatrix’s proposed construction, but that it would not offer an alternate construction.

All of the asserted claims of the ’202 and ’433 patents include a limitation for a

“structurally flexible core” that is coated with an electrochemically active metal, such as

platinum. The patent specification provides ample support for AgaMatrix’s proposed

construction.

The Background of the Invention explains the problem: “[w]ith the advent of indwelling

wire sensors has come the danger to the patient of having a cylindrical wire sensor fatigue from

the flexure caused by bodily movement and break off inside the body.” Aldrich Decl., Ex. 5

(’202 Patent) at 1:10-15 (emphasis added). The patent further explains that “the typical metal

used for such a wire sensor is platinum, which is electrochemically active and generally very

useful in sensing applications.” Id. at 1:19-21. “Platinum, however, is a weak metal that is

easily broken with only a little flexure.” Id. at 1:21-23.

3 For convenience of the Court, two appendices are attached. Appendix A is a master list of the 13 disputed claim terms, as well as two agreed claims terms, and the parties’ competing (or agreed) constructions of those terms. Appendix B reproduces the asserted claims of the ’202, ’433 and ’574 patents for convenience of the Court. 4 Claim 1 of the ’202 Patent uses the term “sensor” to reference the sensor wire. Claim 1 of the ’433 Patent uses the term “sensing element.”


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The patent explains that the solution to the breakage problem is the use of a robust,

bimetallic sensor wire able to withstand repeated flexing without breaking. See id. at Abstract;

Summary 1:44-46 (“The sensor comprises a core of a structurally robust material and a plated

portion…”); 1:52-55; 1:59-62; 2:24-28; 2:33-37; 2:59-61; 3:9-12; 3:15-19; 3:19-24; 3:21-24 (all

referencing the requirement for a robust bimetallic sensor wire). The specification further

describes a subset of naturally flexible materials that are particularly well-suited for being

inserted into a patient for a period of days. Specifically, the Detailed Description of the

Preferred Embodiment describes:

[a] wire core . . . of any structurally robust material, such as tantalum, stainless steel or nitinol. Tantalum and nitinol, although both fairly expensive, are desirable because they are both naturally flexible. This is of particular importance if sensing element 12 is to be inserted in a patient and worn for a period of days.

Id. 2:33-39 (emphasis added).

Claim 9 of the ’202 Patent reinforces that the wires must be designed for extended use by

requiring that the sensor is placed in the “body for at least 24 hours.” Id. Because “an

independent claim should be given broader scope than a dependent claim to avoid rendering the

dependent claim redundant,” Phillips, 415 F.3d at 1324, independent claim 1, from which claim

9 depends, has a broader scope than claim 9 and thus encompasses sensors that are designed to

be inserted for over a day. Accordingly, AgaMatrix’s proposed construction has ample support

in the disclosures of the ’202 patent.

Dexcom recently abandoned its proposed construction

Pursuant to the Scheduling Order, the parties exchanged proposed constructions on

October 21, 2016. Dexcom proposed that “structurally flexible core” meant “element that is

capable of being bent repeatedly and is not easily broken with little flexure and having sufficient

strength to pierce the skin.” Dexcom has proposed a different construction to the Patent Office,

to which it has submitted two Petitions for Inter Partes Review in an attempt to invalidate the

’202 and ’433 patents. There, Dexcom proposed a construction that it alleged was the “broadest


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reasonable interpretation,” arguing that “structurally flexible” should be construed to mean

“capable of being bent or flexed.” See Aldrich Decl. Ex. 6 (’202 Petition) at 7, Ex. 7 (’433

Petition) at 8. However, on the afternoon of Friday, November 18, two days prior to the

requisite filing of these opening claim construction briefs, counsel for Dexcom informed

AgaMatrix that it was withdrawing its proposed construction for “structurally flexible core,” that

it objects to and disagrees with AgaMatrix’s proposed construction, and that it has no alternative

construction to propose.

Because AgaMatrix’s construction is the only one offered, and is fully supported by the

evidence, it should be adopted.

B. The “Surrounding” and “Further Surrounding” Terms

No. Claim term AgaMatrix Construction Dexcom Construction 2. “surrounding, covering,

and in contact with said outer surface of said core” ’202 and ’433 Patents (all asserted claims)

Plain and ordinary meaning. No construction needed. The phrase “said outer surface of said core” is construed below.

Disposed on entire outer surface of the core, such that no portion of that outer surface is exposed to bodily fluids

3. “[further]5 surrounds, covers, and is in contact with at least a first end of said core.” ’202 Patent claim 11 ’433 Patent claim 11

Plain and ordinary meaning. No construction needed. The phrase “a first end of said core” is construed below.

Disposed on entire outer surface of the core, such that no portion of the outer surface is exposed to bodily fluids

Dexcom’s effort to fabricate an infringement defense is particularly transparent with

respect to this pair of terms. Dexcom chooses to deliberately ignore obvious differences between

independent claim 1 and dependent claim 11 of both patents, by giving them identical

meanings—improperly rendering claim 11 a nullity. Specifically, claims 1 and 11 recite as

follows: 5 We place the term “further” in brackets because Dexcom elected to omit the important signal provided by this term from the phrase it has proposed for construction.


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1. . . . a layer of electrochemically active metal surrounding, covering, and in contact with said outer surface of said core . . .

11. The method of claim 1, wherein . . . said electrochemically active layer further surrounds, covers, and is in contact with said at least a first end of said core.

Reading these limitations in conjunction, only one interpretation is possible: the “outer

surface” of the core in claim 1 is one of the surfaces of the core that must be covered.6

According to claim 11, the core further comprises “a first end” surface and that “first end”

surface must further be covered.

Indeed, the sole difference between claim 1 and claim 11 is claim 11’s addition of a

limitation that requires a “first end” to further be covered by the electrochemically active metal.

Under the doctrine of claim differentiation, the additional limitation of claim 11 must be given

meaning such that claim 11 is not rendered coextensive in scope with claim 1, and therefore

superfluous. See Trebro Mfg. v. FireFly Equip., LLC, 748 F.3d 1159, 1167 (Fed. Cir. 2014);

Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910 (Fed. Cir. 2004). While Dexcom’s

proposed construction that the outer surface must be “entirely” covered is ambiguous, if it is

meant to suggest that claim 1 requires all surfaces of the core, including the “first end” surface to

be covered, then that meaning conflicts with the requirement that claim 11 be given meaning.

Dexcom’s proposed construction also improperly imports language that “surrounding,

covering and contacting” means that “no portion of [the] outer surface is exposed to bodily

fluids.” But, with respect to the ’202 patent, there is no language in the claims regarding bodily

fluids contacting or not contacting the core. (See Appendix B). Dexcom’s attempt to add this

functional language to the ’202 patent claims changes the meaning of the claims, has no support

in the claims or the prosecution history of the ’202 patent, and should be rejected. See, e.g.,

Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358, 1367 (Fed. Cir. 2001) (“Where the function is

not recited in the claim itself by the patentee, we do not import such a limitation.”); Transmatic,

6 We use the term “cover” here as short-hand for the full phrase “surround[], cover[] and in contact with.”


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Inc. v. Gulton Indus., 53 F.3d 1270, 1278 (Fed. Cir. 1995) (error to import into a structural claim

element functional limitations not supported by claim language).

By comparison, the ’433 Patent does recite that the electrochemically active metal

“prevents body fluid from contacting said core.” However, that limitation is already in the claim.

Adopting Dexcom’s construction would produce an unnecessary and confusing redundancy, as

shown below:

a continuous layer of electrochemically active metal disposed on entire outer surface of the core, such that no portion of that outer surface is exposed to bodily fluids, wherein the electrochemically active metal prevents body fluid from contacting said core

This redundancy would be confusing to the jury and should not be adopted. See Atlas IP,

LLC v. St. Jude Med., Inc., 804 F.3d 1185, 1190 (Fed. Cir. 2015) (rejecting proposed

construction that “would render [the claim]’s language redundant”).

C. “Said Outer Surface of Said Core” and “A First End of Said Core”

No. Claim term AgaMatrix Construction Dexcom Construction 4. “said outer surface of said

core” ’202 and ’433 Patents (all asserted claims)

the cylindrical surface of the core

No construction needed.

5. “a first end of said core” ’202 Patent claim 11 ’433 Patent claim 11

the distal tip of the core No construction needed.

As discussed in section B above, the term “outer surface” in independent claim 1 must be

construed to have a different meaning from “a first end” in dependent claim 11 in order to avoid

rendering claim 11 a nullity.

Consistent with this distinction, Figure 1 of the patents illustrate an embodiment in which

the core (24) has multiple surfaces, including a cylindrical outer surface (bounded in red) and a

separate first end surface, or “distal tip” surface, which is conical in shape (bounded in blue):


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7

Moreover, one of ordinary skill in the art, reading the specification, would understand

why the patentee would claim covering “an outer surface” of the core in claim 1, and then

separately claim “further” covering “a first end” of the core in claim 11. As explained by Dr.

Smith, the patent discloses multiple ways of making a sensor wire with an electrochemically

active metal coated onto a core metal. Smith Decl. ¶ 38. One of those ways, described in the

’433 Patent at 2:48-59, involves using a DFT, or “drawn filled tube.” This technique creates a

long wire of coated metal. That wire is then cut into small sections for use as sensor wires.

Smith Decl. ¶ 39. The cutting may result in the electrochemically active metal being smeared

across the end surface of the wire, potentially leaving the “first end” surface incompletely

covered. Id. Likewise, there is an embodiment that discloses a method where a “core of robust

metal is circumferentially clad in noble metal foil.” Aldrich Decl. Ex. 8 (’433 Patent) at 3:8-13.

This technique, which only coats the cylindrical surface, would also leave the end surfaces

exposed. See Smith Decl. ¶ 40. Other methods of manufacture disclosed in the patent would

7 The term “distal tip” is used to refer to the tip end of the sensor that is inserted into the skin.


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result in both the cylindrical surface of the core and the distal tip (first end) surface of the core

being covered. Id. at ¶¶ 41-42.

This intrinsic evidence explains the patentee’s strategy of separately claiming covering

“an outer surface” in claim 1 and further covering “a first end” in claim 11. Accordingly, the

patentee’s distinction between an “outer surface” and a “first end” (or “distal tip”) in claims 1

and 11 is consistent with the disclosure of the patent specification and the understanding that a

person of ordinary skill in the art would have had after reading the patent. See Phillips, 415 F.3d

at 1315 (“[T]he specification is always highly relevant to the claim construction analysis.

Usually, it is dispositive…”) (internal quotation omitted); Aventis Pharms., Inc. v. Amino Chems.

Ltd., 715 F.3d 1363, 1374 (Fed. Cir. 2013) (“[W]e must always construe the specification in light

of the knowledge of one of ordinary skill in the art.”)

Dexcom’s assertion that these terms need no construction reflects its effort to ignore the

important distinctions that exist between claims 1 and 11 of the ’202 and ’433 patents, as

discussed above. On the other hand, AgaMatrix’s construction of “said outer surface of said

core” as “the cylindrical surface of the core” is consistent with the usage of this term in the

specification, the claims and the prosecution of the patent, as it would have been understood by a

person of ordinary skill in the art. AgaMatrix’s construction of “a first end of said core” as “the

distal tip of the core” is likewise consistent with the evidence. Indeed, Dexcom uses the terms “a

first end of the core” and “a distal tip” of the core interchangeably in its petitions for Inter Partes

Review (“IPR”) of the ’202 and ’433 patents. See Aldrich Decl. Ex. 6 (’202 Petition) at 26-27;

Ex. 7 (’433 Petition) at 50-51.

For these reasons, the Court should adopt AgaMatrix’s constructions, which are

consistent with the claims and specification, and also comport with the Federal Circuit’s rules for

claim construction.


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D. “Electrochemically Active Metal Prevents Body Fluid from Contacting said Core”

No. Claim term AgaMatrix Construction Dexcom Construction 6. “electrochemically active

metal prevents body fluid from contacting said core” ’433 Patent, all asserted claims

Plain and ordinary meaning. No construction needed.

The electrochemically active metal prevents any bodily fluids from contacting the core anywhere.

Dexcom’s construction is almost a verbatim copy of the claim term itself, except that it

has added the word “anywhere,” though that word is not used in the claims, the specification, or

the prosecution history of the ’433 patent. It is inappropriate to construe a claim term by adding

a new word to the original language in a manner that changes its meaning. Advanced Steel

Recovery, LLC v. X-Body Equip., Inc., 2013 U.S. Dist. LEXIS 128667, *38 (E.D. Cal. Sept. 6,

2013) (rejecting such a construction advanced to fit defendant’s non-infringement theory).

Rather, where a party’s proposed construction “is almost verbatim of the definition provided in

the claims themselves . . . no construction is necessary.” Sipco LLC v. Toro Co., 2009 U.S. Dist.

LEXIS 10312, *47-48 (E.D. Penn. Feb. 10, 2009); Motorola Mobility, Inc. v. TiVo, Inc., 2012

U.S.Dist. LEXIS 174026, *70-75 (E.D. Tex. Dec. 5, 2012) (where one party’s “proposed

construction… is nearly identical to the claim language itself,” the term has its plain and ordinary

meaning.)

Moreover, adding the gratuitous word “anywhere” to the claim is inconsistent with what

a person of ordinary skill in the art would have understood from reading the patent specification.

A dielectric (plastic) insulating material protects the core from exposure to body fluids

everywhere except in the sensing region where the membranes permit body fluid to reach the

electrochemically active metal. For example, Figure 1 shows the distal tip entirely coated in a

protective polyimide 23 layer (highlighted in blue):


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The polyimide-coated tip is further described in the specification:

Wire 20 is coated with a protective layer 23, made of durable, non-toxic material such as polyimide, except for where coated by membrane system 22. In production, protective layer 23 is dip-coated onto wire 20 and then removed, preferably with an excimer or ND:YAG laser in the area in which membrane system 22 is to be applied.

Aldrich Decl. Ex. 8 (’433 Patent) at 2:18-23 (emphasis added). Thus, the electrochemically

active metal does not prevent body fluids from contacting the core at the distal tip; that job is

performed by the protective dielectric layer.

Dexcom’s construction would confuse the jury by implying that the electrochemically

active metal has to be the structure that prevents the bodily fluids from contacting the core

everywhere, even where the plastic layer is actually performing that function. This is not what

the specification discloses or what the claims require. Dexcom actually agrees, and has argued

as much to the Patent Office. In a petition for Inter Partes review filed with respect to the ’433


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patent, Dexcom asserted that a Japanese patent application (“Hagiwara”) anticipates this claim

term. Hagiwara discloses a sensor with a core wire (3):

Aldrich Decl., Ex. 7 (’433 Patent IPR Petition) at 13. The distal tip is covered in membranes (5)

and (6), which allow chemicals from body fluids to enter, and be sensed at the tip of the wire (2).

Elsewhere, the sensor wire is shielded from body fluids by protective layers such as resin 9 and

outer tube 8. See id. at 16.

According to Dexcom, Hagiwara discloses plating a noble metal (red) only “on the front

ends” of the core (blue), which Dexcom depicted in its modified version of FIG 1(B) of the

Hagiwara reference that is reproduced below:

Id. at pp. 13, 14. In its IPR petition, Dexcom asserts that Hagiwara teaches the “preventing body

fluid from contacting the core” limitation, because:

Bodily fluids are only able to access the metal wire 1 through membranes 5 and 6 via the opening 2 . . . Because the core of the senor [sic] wire 1 is plated at that point 2, bodily fluids have no


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path to reach the core (blue above) of the Hagiwara electroplated wire.

Hagiwara therefore discloses the electrochemically active metal preventing body fluid from contacting said core.

Id. p. 16. Thus, Dexcom has admitted that a person of ordinary skill in the art would understand

that the electrochemically active surface need not prevent body fluids from contacting the core

everywhere, but instead, it only needs to prevent body fluids from contacting the core where the

core is otherwise exposed—i.e., in the sensing region where the body fluid is permitted to reach

the electrochemically active metal. Having taken this position before the Patent Office, Dexcom

should not be heard to argue otherwise here. See Thomas Swan & Co. v. Finisar Corp., 2014

U.S. Dist. LEXIS 86209, *70 (E.D. Tex. June 25, 2014) (where “Defendants’ position

contradicts [its] representation to the Patent Office in connection with its IPR,” adopting

plaintiff’s proposed construction).

The word “anywhere” changes the term’s meaning (otherwise, why add it?), and is

contradicted by the intrinsic evidence. It should not be added. For these reasons, the Court

should adopt the plain and ordinary meaning of this claim term. No construction is needed.

V. DISPUTED CLAIM TERMS OF THE ’574 PATENT

The parties have identified seven terms for construction in the ’574 Patent. These terms

relate to three disputes.

A. The “Electrochemically Active Surface” Terms

The ’574 patent explains the method for creating the sensor:

The method starts with the step of providing an electrochemically active surface. Then, at least one nub made of dielectric material and extending transversely outwardly from the electrochemically active surface is created. A curable liquid is applied to the electrochemically active surface and the nub and is then cured.

Aldrich Decl., Ex. 3 (’574 Patent) at 1:27-33. Referencing the figure reproduced below, the

method starts with a wire made from an electrochemically active metal (12). Id. 1:52-54. Then

plastic nubs (14, 22) are added to the surface, defining cavities, or “sensing regions,” between


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the nubs. Finally, the wire is “dip coated” with an enzyme-containing liquid (24) that allows the

wire to detect glucose. The result is shown in Figure 2:

Claim 1 recites as follows:

1. An indwelling analyte sensor, comprising:

an electrochemically active surface;

at least two nubs of dielectric material extending outwardly from said electrochemically active surface and forming a cavity along said electrochemically active surface and between said at least two nubs; and

a membrane system comprising an enzyme layer, said enzyme layer surrounding said at least two nubs and said electrochemically active surface at least along said cavity.

Several of the disputed terms concern the term “electrochemically active surface.”

AgaMatrix contends that the “electrochemically active surface” is the entire outer surface of the

sensor wire 12, as highlighted in blue below:


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Dexcom, on the other hand, contends that the “electrochemically active surface” is

restricted to the portions of the wire’s surface that are positioned in the cavities between the nubs

(14, 22), as highlighted in blue below:

Dexcom’s attempt to limit the “electrochemically active surface” to just those portions of

the wire between the nubs is directly contradicted by the plain language of the claims. For

example, claim 1 explains that the nubs “extend[] outwardly from said electrochemically active

surface.” (emphasis added). From this, it is clear that the electrochemically active surface

extends directly underneath the nubs, not just in the cavity between the nubs. Similarly, claim 10

states that the electrochemically active surface “extends through” the nubs. This language makes

crystal clear that the electrochemically active surface is not limited to the wire between the nubs,

as Dexcom would have it, but includes portions of the sensor wire “extending through” the nubs.

The Federal Circuit has instructed that “[c]laim construction begins with the language of the

claims themselves.” Imaginal Systematic, LLC v. Leggett & Platt, Inc., 805 F.3d 1102, 1108

(Fed. Cir. 2015). Any proposed construction that is directly contradicted by the plain language

of the claims must be rejected. See, e.g., Apple Inc. v. Motorola, Inc. 757 F.3d 1286, 1305 (Fed.

Cir. 2014) (rejecting construction that “contradicts the claim language”).

Moreover, the language of claims 1 and 10 has ample support in the written description

of the ’574 patent. For example, the Abstract explains that the “electrochemically active

surface” has nubs that “extend[] transversely outwardly from the electrochemically active


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surface.” Figure 1 below shows the nubs (in green) extending transversely outwardly from the

electrochemically active surface (blue), which surface extends the full length of the wire (12):

The disputes concerning the following claim terms flow from this fundamental dispute

about the meaning of “electrochemically active surface.”

1. “Electrochemically Active Surface”

No. Claim term AgaMatrix Construction Dexcom Construction 7. “electrochemically active

surface” ’574 Patent claim, all claims

Surface of an electrochemically active substance, such as platinum

Portion of wire surface corresponding to active sensing region where electrochemical reactions occur

As explained above, Dexcom’s attempt to limit the “electrochemically active surface” to

just those portions of the wire in the cavity between the nubs (where the active sensing region

resides) is directly contradicted by the claims and the written specification of the ’574 patent.

Claim 1 states that the “nubs” “extend[] outwardly from said electrochemically active surface.”

(See Appendix B) (emphasis added). In other words, the electrochemically active surface

includes the wire surface that is surrounded by the plastic nubs, not just the wire surface in the

cavity between the nubs. Similarly, claim 10 recites that the electrochemically active surface

“extends through” the nubs.” Finally, claim 9 states that the sensing region lies along only a

portion of the electrochemically active surface. (Appendix B). According to the plain language

of the claims and the specification of the ’574 patent, the entire metal wire provides the

electrochemically active surface. See also Smith Decl. ¶ 53. Because Dexcom’s proposed

construction is directly contradicted by the claims and specification of the ’574 patent, it should


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be rejected. AgaMatrix’s construction, on the other hand, comports with the plain meaning of

the ‘574 patent claims, and should be adopted.

2. “Cavity”

No. Claim term AgaMatrix Construction Dexcom Construction 8. “cavity along said

electrochemically active surface and between said at least two nubs” ’574 Patent claim, claim 1

Plain and ordinary meaning. No construction needed. “Electrochemically active surface” defined above and “nubs” defined below.

Area between the at least two nubs and above the portion of the platinum surface corresponding to the active sensing region

Dexcom’s construction of this term is incorrect for the same reasons explained above.

Namely, Dexcom’s attempt to limit the “electrochemically active surface” to just that portion of

the wire corresponding to the active sensing regions (i.e., portions of the wire in the cavity

between the nubs), is directly contradicted by the claims and the specification of the ’574 patent.

Further, Dexcom’s use of the word “platinum” is overly restrictive, and precludes any other

forms of electrochemically active surfaces. Dexcom’s construction should not be adopted; the

plain and ordinary meaning of the term “cavity” in the context of this patent can be readily

understood by the jury.

3. “Sensing Region”

No. Claim term AgaMatrix Construction Dexcom Construction 9. “a sensing region along a

portion of said electrochemically active surface” ’574 Patent claim, claim 9

An area for sensing an analyte along a portion of said electrochemically active surface

The region around the electrochemically active surface

10. “active sensing region” ’574 Patent claim, claim 9

Sensing area with an enzyme layer8

8 On the evening of November 21, 2016, Dexcom notified AgaMatrix that, despite earlier disputing the term, it now agrees with AgaMatrix’s proposed construction of “active sensing region,” which is “sensing area with an enzyme layer.” We leave the term in the brief because it provides context for disputed term no. 11.


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Claim 9 recites

an electrochemically active surface defining a sensing region along a portion of said electrochemically active surface;

[and]

a membrane system comprising an enzyme layer, said enzyme layer surrounding said sensing region of said electrochemically active surface to form an active sensing region and surrounding said plurality of nubs.

The structure here is clear—there is an electrochemically active surface, a portion of

which is a sensing region, and when the enzyme membrane layer is added, an active sensing

region is created. AgaMatrix’s constructions of these two terms accurately state this structure,

and Dexcom has since adopted AgaMatrix’s proposed construction of “active sensing region,”

leaving only the “a sensing region along a portion of said electrochemically active surface” claim

term for construction.

Dexcom’s construction of this latter term is incorrect. Its attempt to make the

“electrochemically active surface” co-extensive with the “sensing region” is contradicted by the

plain language of claim 9, which states that the “sensing region” lies along only “a portion of

said electrochemically active surface.” (Emphasis added). Moreover, Dexcom has converted a

“sensing region along a portion” of the surface to a “region around the” surface. The word

“around” is unsupported by the specification, and adds ambiguity into an otherwise clear phrase.

Moreover, having now agreed that the “active sensing region” is the sensing area of the

electrochemically active surface with the enzyme layer added, Dexcom’s proposed construction

renders these two terms redundant. Such a construction would violate clear canons of claim

construction, and is also inconsistent with the plain language of claim 9. See Applied Med. Res.

Corp. v. United States Surgical Corp., 448 F.3d 1324, 1333 n. 3 (Fed. Cir. 2006) (“[I]n the

absence of any evidence to the contrary, we must presume that the use of different terms in the

claims connotes different meanings.”) (quotation and internal modification omitted).


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4. “Nub Displaced Longitudinally”

No. Claim term AgaMatrix Construction Dexcom Construction 11. “[nub]9 displaced

longitudinally from said electrochemically active surface” ’574 Patent claim, claims 6 & 17

Plain and ordinary meaning. No construction needed. “Electrochemically active surface” is defined above. “Nubs” is defined below.

Invalid under 35 U.S.C. § 112[b] as being unclear

“Displaced longitudinally from said electrochemically active surface” should be given its

plain and ordinary meaning. No construction is required. An example is shown in Figure 1 of

the patent:

The end nub is displaced longitudinally from the electrochemically active surface 12, as

indicated by the orange arrow.

Dexcom argues that this term is indefinite, and that these claims should be held invalid

pursuant to 35 U.S.C. § 112(b).

9 The term “nub” is in brackets because it adds meaning to the phrase by stating that it is the nub that must be displaced longitudinally.


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However, “[a] patent is presumed valid under 35 U.S.C. § 282 and, ‘consistent with that

principle, a [fact finder is] instructed to evaluate . . . whether an invalidity defense has been

proved by clear and convincing evidence.’” Biosig Instruments, Inc. v. Nautilus, Inc., 783 F.3d

1374, 1377 (Fed. Cir. 2015) (quoting Microsoft Corp. v. i4i Ltd. P'ship, 564 U.S. 91, 93 (2011)).

Dexcom bears the burden of proving invalidity by the clear and convincing evidence standard.

Microsoft Corp., 564 U.S. at 95. A patent claim is only “invalid for indefiniteness if its claims,

read in light of the specification delineating the patent, and the prosecution history, fail to

inform, with reasonable certainty, those skilled in the art about the scope of the invention.”

Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. ___, 134 S. Ct. 2120, 2124 (2014).

“In the face of an allegation of indefiniteness, general principles of claim construction

apply. . . . In that regard, claim construction involves consideration of primarily the intrinsic

evidence, viz., the claim language, the specification, and the prosecution history.” Biosig, 783

F.3d at 1377.

Dexcom cannot show by clear and convincing evidence that a person of ordinary skill in

the art would not know, with reasonable clarity, what is meant by “displaced longitudinally from

said electrochemically active surface,” particularly given the disclosure in Figure 1 showing the

end nub displaced longitudinally from the electrochemically active surface of sensor wire 12.

Dr. Smith explains that a person of ordinary skill in the art would be reasonably certain of what

is meant by this claim term. Smith Decl. ¶¶ 55-56.

B. “Nubs”

No. Claim term AgaMatrix Construction Dexcom Construction 12. “nubs”

’574 Patent claim, all claims

Protruding structures Small lump or protuberance having first, second, and third surfaces.


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1. Background concerning “nubs”

All asserted claims of the ’574 patent include “nubs” of dielectric material on the sensor

wire. Dielectric material is non-conducting material that can perform as a protective insulator in

an electrical system. See Smith Decl. ¶ 47. The dielectric of the ’574 patent can be a plastic

such as polyimide. See id. As shown in Figures 1 and 2 of the ’574 patent, the plastic nubs are

protruding structures that extend transversely outwardly from portions of the electrochemically

active surface. They provide supportive structures for the membrane system, which surrounds

the wire in the cavity between the nubs, and also encircle the nubs adjacent the cavity. Aldrich

Decl., Ex. 3 at Fig. 2 and 1:18-25.

In one preferred embodiment, a platinum wire is coated with a “thick polyimide layer 14.

A silver wire 16 is wrapped about a portion of layer 14 . . . Three cavities 20 . . . are formed by

laser ablating the polyimide layer 14 to form a work piece 8.” Id. 1:54-58. As a result, each

cavity is bounded by two plastic nubs.

The work piece is then dip-coated in a viscous, enzyme-containing liquid that is heat

cured to form a fixed membrane layer on the workpiece. Aldrich Decl., Ex. 3 at 1:57-2:4; Smith

Decl. ¶ 48. The inventors discovered that the liquid would flow off of the cylindrical wire,

leading to an uneven and too-thin membrane layer. By creating the protruding nub structures,

more liquid is retained on the wire, producing thicker membrane layers. Aldrich Decl. Ex. 3 at

2:4-10; Smith Decl. ¶¶ 46-52. As shown in Fig. 2 below, the membranes (24) encircle the wire

(12) in the cavity between the nubs, as well as the plastic nubs adjacent the cavities (14, 22):


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2. “Nubs” are protruding structures

The term “nub,” means “[a] protuberance or knob.” Aldrich Decl., Ex. 9 (Webster’s II

New Riverside University Dictionary at 806.) A “protuberance” is “[s]omething, as a bulge or

knob, that protrudes.” Id. at 947. AgaMatrix’s proposed construction thus is consistent with the

plain and ordinary meaning of the term “nub.”

3. The nubs are not limited to “annular plates,” but also include the proximal and distal nubs shown in Figures 1 and 2 of the ’574 patent.

Dexcom apparently seeks to limit “nubs” to “annular plates” by requiring that the nubs

have three surfaces, like the annular plate nubs (22). However, the specification makes clear that

annular plates are just one form of nubs. More specifically, it references “nubs, such as annular

plates 22.” Aldrich Decl., Ex. 3 (’574 Patent at 1:61-62). So, rather than disclosing that the nubs

must be annular plates, as Dexcom would have it, the specification confirms the opposite,

namely, that annular plates are just one type of nub. “It is a basic tenet of claim construction that

examples or embodiments described in the specification do not limit claim language, absent clear

intent.” Computer Stores Northwest, Inc. v. Dunwell Tech., Inc., 2011 U.S. Dist. LEXIS 58660,

*119 (D. Or. May 31, 2011), citing Liebel-Flarsheim, 358 F.3d 906 (“Even when the

specification describes only a single embodiment, the claims of the patent will not be read

restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using

words or expressions of manifest exclusion or restriction.”) (internal quotation and citation

omitted). Accordingly, the “nubs” term is not limited to “annular plates” having three surfaces.10

10 Indeed, the intrinsic evidence fails to establish that “annular plates” are limited to

structures with three surfaces given that the figures of a patent are intended for illustrative


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The claims of the ’574 patent confirm this understanding. Specifically, independent

claim 1 recites the presence of “at least two nubs of dielectric material.” See Appendix B.

Dependent claim 2 adds the limitation that at least one of the nubs “is in the form of a plate.” Id.

Dependent claim 3 adds the limitation that at least one of the nubs “comprises an annular plate.”

Id. The doctrine of claim differentiation provides that the “nub” term in claim 1 must be

construed more broadly than the “plate” and “annular plate” terms in dependent claims 2 and 3,

else the latter two claims would be rendered superfluous. Comark Communs., Inc. v. Harris

Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998) (quotation omitted). That doctrine is at its strongest

where, as here, the dependent claim adds only a single limitation. SunRace Roots Enter. Co. Ltd.

v. SRAM Corp., 336 F.3d 1298, 1302-03 (Fed. Cir. 2003).

4. Dexcom’s construction is not the plain and ordinary meaning, and is inconsistent with the prosecution history

Dexcom’s proposed construction limiting the claims to only “small lumps or

protuberances” having three surfaces improperly excludes nubs of other sizes and shapes. There

is nothing in the claims, specification or prosecution history of the ’574 patent that would

preclude spherical or cubic nubs, or nubs having irregular non-geometric surfaces. Accordingly,

Dexcom’s narrow, three-surface construction lacks support in the relevant evidence.

Indeed, the evidence indicates that “nubs” may come in a wide range of shapes and sizes.

During prosecution, the examiner identified a variety of nubs, not all of which are “small lumps,”

and not all of which have “three surfaces.”

For example, in U.S. Patent No. 4,671,288, the Examiner identified 18 (in blue) as the

electrochemically active surface, and “3 nubs 27 of dielectric material” (in red):

purposes and generally do not limit the claims of a patent. See Gart v. Logitech, Inc., 254 F.3d 1334, 1342 (Fed. Cir. 2001) (patent drawings “are not meant to represent ‘the’ invention or to limit the scope of coverage defined by the words used in the claims themselves”); MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1333 (Fed. Cir. 2007) (to limit claims to depictions in figures “would be to import limitations into the claim from the specification, which is fraught with danger.”) (citation and internal quotation omitted).


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Aldrich Decl., Ex. 10 (6/27/06 Office Action) at p. 3; Ex. 11 (US Patent No. 4,671,288).

In U.S. Patent No. 4,919,141, the Examiner identified 14 (in blue) as the

electrochemically active surface, and 12 (in red) as a “nub.”

Id. at Ex. 12 (12/27/07 Office Action) at p. 2; Ex. 13 (US Patent No. 4,919,141).

In U.S. Patent No. 4,388,166, the Examiner identified 8a (in blue) as the

electrochemically active surface, and “the material surrounding lead 8a” (in red) as a “nub.”


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Id., Ex. 14 (4/15/08 Office Action at p. 2); Ex. 15 (US Patent No. 4,388,166).

Applicants did not dispute the Examiner’s assertions that these variously-shaped and

sized objects all were “nubs” within the meaning of the ’574 patent claims. Based on this

prosecution history, nubs need not be small lumps or protuberances, or have three sides and three

sides only. The Court should not adopt these limitations, which have no support in the claims,

the specification or the prosecution history of the ’574 patent. AgaMatrix’s proposed

construction is consistent with the plain and ordinary meaning of “nubs” and should be adopted.

C. “Surrounding”

No. Claim term AgaMatrix Construction Dexcom Construction 13. “surrounding said at least

two nubs and said electrochemically active surface at least along said cavity” ’574 Patent claim, claim 1

Plain and ordinary meaning. No construction needed. The “nubs” and “electrochemically active surface” terms are defined above.

The enzyme layer completely covers all three surfaces of the nubs and the electrochemically active surface that corresponds to the active sensing region

14. “said enzyme layer surrounding said sensing region of said electrochemically active surface to form an active sensing region and

Plain and ordinary meaning. No construction needed. Constructions for “said sensing region,”

The enzyme layer completely covers all three surfaces of the nubs and the electrochemically active surface that corresponds to the active sensing region


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surrounding said plurality of nubs” ’574 Patent claim, claim 9

“electrochemically active surface,” and “nubs” are provided above.

The term “surrounding” is a common word that is easy for a jury to understand and

apply. It does not need to be construed by this Court. A dictionary definition of “surrounding,”

is: “To extend around the margin or edge of: encircle.” Aldrich Decl., Ex. 16 (Merriam-

Webster’s Collegiate Diction, 10th Ed. at 1183). During prosecution, the Examiner and

applicants reached an express agreement that “surround” should be understood to mean

“encircle” for purposes of these patent claims.

For example, the Examiner stated that he would apply the “encircle” interpretation to the

claims:

Before applying art, the examiner notes that applicant has stated that the term “surround” does not require that the membrane cover the active surface on all sides. To the best of the examiner’s understanding, then, applicant merely intends the term to mean contained with and covered by, for example encircled by, and this is the interpretation that will be applied to the claims.

Aldrich Decl., Ex. 17 (Office action dated Sept. 13, 2007) at 2.

The Applicants later confirmed their agreement with the Patent Office Examiner that the

term “surround” should be understood to mean encircled:

The term “surround” has been discussed at length as providing for one element to encircle one or more other underlying elements. This understanding was stated clearly at page 2, lines 6-10, of the September 13, 2007 Office Action. This understanding is also consistent with the prior discussions on the subject, and is consistent with the representation in Figure 2 of the present application. In a general sense, the term “surround” is intended to mean that the membrane provides a covering/coating encircling the stated underlying element(s). When considering the scope of the term, reference to Figure 2 shows that the membrane system does not simply cover or abut an end of the device, but rather encircles the active surface and the nub(s).

Aldrich Decl., Ex. 18 (Remarks dated June 25, 2008) at 5-6.


Dexcom Exhibit 1002




Fax: 503.796.2900

This agreement between the Patent Office and the applicants on the meaning of the

“surround” term served a public notice function such that anyone reading the application would

understand that “surround” is used in the patent claims to mean “encircling.” See, e.g., Phillips,

415 F.3d at 1319 (Fed. Cir. 2005) (meaning of claims should not be changed “in derogation of

the indisputable public records consisting of the claims, the specification and the prosecution

history, thereby undermining the public notice function of patents”).

Dexcom’s proposed construction of these claim terms is wrong for a number of reasons.

First, as discussed above, Dexcom’s attempt to limit “nubs” to structures with three surfaces has

no support in the specification, claims or prosecution history of the ’574 patent, and must be

rejected.

Second, the phrase “the electrochemically active surface that corresponds to the active

sensing region” is confusing and ambiguous. To the extent it is meant to suggest that the active

sensing region and electrochemically active surface are longitudinally co-extensive, it is wrong

for all the reasons discussed above. The intrinsic evidence makes clear that the surface of the

entire sensor wire provides an electrochemically active surface (e.g., a platinum surface), not just

the portion of the wire in the cavity between the nubs.

Third, Dexcom’s requirement that “surround” means “completely covers all three

surfaces of the nub” is directly contradicted by the explicit agreement between the Patent Office

and the applicants on the meaning of the term, insofar as “encircling” does not denote any such

requirement. Aldrich Decl., Ex. 17 (9/13/07 Office Action) (“[T]he examiner notes that

applicant has stated that the term ‘surround’ does not require that the membrane cover the active

surface on all sides.”)

This view is further confirmed by the specification of the ’574 Patent, which explains that

“[a] silver wire 16 is wrapped about a portion of layer 14.” Aldrich Decl., Ex 3 at 1:54-55. The

dielectric material extends under the silver coil, as shown in the enhanced image below:


Dexcom Exhibit 1002




Fax: 503.796.2900

However, the membrane does not “surround” the polyimide that extends under the coil

(16). Instead, the membrane (in yellow, below) encircles the plastic “nub” (14) adjacent to

cavity, where that nub fulfills its role as a supportive structure for the membrane that spans the

cavity to the opposing nub structure (22) on the other side. Smith Decl. ¶ 51.

For these reasons, “surrounding” does not have the narrow meaning that Dexcom ascribes to it.

Instead, as agreed during prosecution of the ’574 patent application, “surrounding” carries its

plain and ordinary meaning, which includes “encircling.”

//

//

//

//


Dexcom Exhibit 1002




Fax: 503.796.2900

V. CONCLUSION

AgaMatrix respectfully requests that the Court enter its proposed constructions of the

disputed claim terms.

Dated this 22nd day of November, 2016. Respectfully submitted,

SCHWABE, WILLIAMSON & WYATT, P.C.

By: s/ Scott D. Eads Scott D. Eads, OSB #910400 Email: [email protected] Nicholas F. Aldrich, Jr., OSB #160306 Email: [email protected] Jason A. Wrubleski, OSB #120524 Email: [email protected] Telephone: 503.222.9981 Facsimile: 503.796.2900 Of Attorneys for Plaintiff AgaMatrix, Inc.


Dexcom Exhibit 1002

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