Mark Connot (10010) FOX ROTHSCHILD LLP...ACTIVE\50721804.v1-8/28/17 Mark Connot (10010) FOX...

$: Mark Connot (10010) FOX ROTHSCHILD LLP...ACTIVE\50721804.v1-8/28/17 Mark Connot (10010) FOX ROTHSCHILD LLP 1980 Festival Plaza Drive, Suite 700 Las Vegas, Nevada 89135 Telephone: 702.262.6899$
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28 OPPOSITION TO MOTION TO FOR SUMMARY JUDGMENT

ACTIVE\50721804.v1-8/28/17

Mark Connot (10010) FOX ROTHSCHILD LLP 1980 Festival Plaza Drive, Suite 700 Las Vegas, Nevada 89135 Telephone: 702.262.6899 Fax: 702.597.5503 [email protected] John Shaeffer (admitted PHV) Jeff Grant (admitted PHV) FOX ROTHSCHILD LLP 10250 Constellation Blvd., Suite 900 Los Angeles, California 90067 Telephone: 310.598.4150 Fax: 310.556.9828 [email protected] [email protected] William Rudy (admitted PHV) FOX ROTHSCHILD LLP 1225 17th Street, Suite 2200 Denver, Colorado 80202 Telephone: 303.292.1200 Fax: 303.292.1300 [email protected] Attorneys for Plaintiffs Pharma Tech Solutions, Inc. and Decision IT Corp.

UNITED STATES DISTRICT COURT

DISTRICT OF NEVADA

PHARMA TECH SOLUTIONS, INC. and DECISION IT CORP.,

Plaintiffs,

v. LIFESCAN, INC., LIFESCAN SCOTLAND, LTD. and JOHNSON AND JOHNSON

Defendants.

Case No.: 2:16-cv-00564-RFB-PAL PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT

Case 2:16-cv-00564-RFB-PAL Document 69 Filed 08/28/17 Page 1 of 32

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28 OPPOSITION TO MOTION FOR SUMMARY JUDGMENT

i

TABLE OF CONTENTS

I. INTRODUCTION ................................................................................................................ 1

II. BACKGROUND .................................................................................................................. 2

A. The Parties ................................................................................................................ 2

B. The Prosecution History of the ‘069 .......................................................................... 3

1. The Claims of the Original Application ......................................................... 3

2. Amendment to Include a “Linear Comparison” Limitation ............................ 4

3. Amendments to Rephrase the “Linear Comparison” Limitation ..................... 6

C. The Prosecution History of the ‘411 Patent ............................................................. 11

III. LEGAL STANDARD ........................................................................................................ 11

A. Standard On Summary Judgment ............................................................................ 11

B. Prosecution History Estoppel Does Not Apply Where An Amendment Bears No More Than A Tangential Relation To The Equivalent In Question .......................... 13

C. Argument-Based Estoppel Requires a “Clear and Unmistakable” Surrender of the Subject Matter ......................................................................................................... 16

IV. ARGUMENT ..................................................................................................................... 17

A. The Operation Of The Accused Products (Aka The Equivalent) Was Not Disclosed In The Prior Art ........................................................................................................... 17

1. The Prior Art Does Not Disclose the Actual Equivalent ............................... 17

2. Lifescan’s Expert Concedes That the Prior Art Did Not Disclose the Elements of the “Equivalent” That Lifescan’s Expert Adopted.................................... 20

3. Lifescan’s Motion Abandons an Analysis of the Accused Product as the Equivalent and Instead Focuses on Irrelevant, Generic Similarities .............. 22

B. The Rationale Behind The Amendments Was, At Most, Only Tangentially Related To The Accused Products ............................................................................................. 26

C. Argument Based Estoppel Does Not Apply ............................................................. 27

V. PROSECUTION HISTORY ESTOPPEL DOES NOT ESTOP PLAINTIFFS FROM ASSERTING INFRINGEMENT OF THE ‘411 PATENT IN ACCORDANCE WITH THE DOCTRINE OF EQUIVALENCE...................................................................................... 28

VI. CONCLUSION .................................................................................................................. 28


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ii

TABLE OF AUTHORITIES

Page(s)

Cases

Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336 (Fed. Cir. 2002) ..................................................................................................28

Amgen Inc. v. Hoescht Marion Roussel, Inc., 457 F.3d 1293 (Fed. Cir. 2006) ..................................................................................................25

Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) ..................................................................................................................12

Chimie v. PPG Industries, Inc., 402 F.3d 1371 (Fed. Cir. 2005) ..................................................................................................25

Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352 (Fed. Cir. 2003) ..................................................................................................16

Cordis Corp. v. Medtronic Ave, Inc., 511 F.3d 1157 (Fed. Cir. 2008) ..................................................................................................16

Cross Medical Products, Inc. v. Medtronic Sofamor Danek, Inc., 480 F.3d 1335 (Fed. Cir. 2007) ..................................................................................................25

Deering Precision Instruments, L.L.C. v. Vector Distribution Systems, Inc., 347 F.3d 1314 (Fed. Cir. 2003) ............................................................................................ 16, 27

Eagle Comtronics, Inc. v. Arrow Communication Laboratories, Inc., 305 F.3d 1303 (Fed. Cir. 2002) ..................................................................................................17

Felix v. American Honda Motor Co., 562 F.3d 1167 (Fed. Cir. 2009) ..................................................................................................24

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359 (Fed. Cir. 2003) (en banc) ...................................................................... 12, 14, 27

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 234 F.3d 558 (Fed. Cir. 2000).............................................................................................. 14, 16

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722 (2002) ................................................................................................ 12, 14, 16, 17

Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605 (1950) ..................................................................................................................12


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iii

Henrob Ltd. v. Bollhoff Systemtechnick GmbH & Co., 2009 WL 3199825 (E.D. Mich. Sept. 29, 2009) .........................................................................13

Insituform Technologies, Inc. v. CAT Contracting, Inc., 385 F.3d 1360 (Fed. Cir. 2004) ................................................................................ 15, 16, 26, 27

Integrated Tech. Corp. v. Rudolph Techs., Inc., 734 F.3d 1352 (Fed. Cir. 2013) ..................................................................................................17

International Rectifier Corp. v. IXYS Corp., 515 F.3d 1353 (Fed. Cir. 2008) ..................................................................................................25

Leggett v. Platt, Inc. v. Hickory Springs Mfg. Co., 285 F.3d 1353 (Fed. Cir. 2002) ..................................................................................................12

Luminara Worldwide, LLC v. Liowen Electronics Co. Ltd., 814 F.3d 1343 (Fed. Cir. 2016) ..................................................................................................28

Monolithic Power Systems, Inc. v. O2 Micro Intern. Ltd., 476 F.Supp.2d 1143 (N.D. Cal. 2007) ........................................................................................12

Netword, LLC v. Central Corp., 242 F.3d 1347 (Fed. Cir. 2001) ..................................................................................................11

O2 Micro Inter., Ltd. v. Beyond Innovation Tech. Co., Ltd., 521 F.3d 1351 (Fed. Cir. 2008) ..................................................................................................25

Pacing Technologies, LLC v. Garmin Intern., Inc., 778 F.3d 1021 (Fed. Cir. 2015) ..................................................................................................28

Schwing GmbH v. Putzmeister Aktiengesellschaft, 305 F.3d 1318 (Fed. Cir. 2002) ............................................................................................ 17, 28

Terlep v. Brinkman Corp., 418 F.3d 1379 (Fed. Cir. 2005) ..................................................................................................25

VDP Patent, LLC v. Welch Allyn Holdings, Inc., 2007 WL 14609 (S.D.N.Y. Jan. 2, 2007) ...................................................................................13

Voda v. Cordis Corp., 536 F.3d 1311 (Fed. Cir. 2008) ..................................................................................................16


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OPPOSITION TO MOTION FOR SUMMARY JUDGMENT

1

I. INTRODUCTION

This case presents the archetypal application of the doctrine of equivalents. The Patents-in-

Suit1 are directed to novel means for performing a comparison on analyte measurements to ensure

accurate blood glucose measurements. Defendants Lifescan, Inc., Lifescan Scotland, Ltd. and

Johnson and Johnson (“Defendants” or “Lifescan”) designed a system that tracks the claims of the

Patents-in-Suit, except that Lifescan’s system performs the exact same claimed comparison on

current measurements in lieu of analyte measurements. This supposed distinction, however, is

purely illusory and does not absolve Lifescan of liability. There is a known, constant relationship

between current measurements and analyte measurements. They are perfectly interchangeable –

much like Fahrenheit and Celsius. The doctrine of equivalents was designed to prevent accused

infringers from avoiding liability by relying on technical, insignificant limitations of a claim. This is

precisely what Lifescan seeks to do here.

To avoid accountability for their actions, Defendants’ Motion for Summary Judgment (Dkt.

No. 67) (“Motion”) argues that Plaintiffs PharmaTech Solutions and Decision IT Corp. (“Plaintiffs”)

are estopped from asserting infringement under the doctrine of equivalents because of amendments

and statements made during the prosecution of the Patents-in-Suit. The thrust of Lifescan’s Motion

is that the applicants amended their claims to surrender ground occupied by the Accused Products2

to overcome prior art that disclosed the “equivalent,” which is the term used to describe the Accused

Products for the purposes of the doctrine of equivalents. Lifescan’s theory falls flat because none of

the prior art references cited during prosecution disclosed a system that operates in the manner that

the Accused Products operate. Lifescan’s Motion attempts to obfuscate this unavoidable conclusion

by a late switch of the definition of “equivalent” to one that is convenient for Lifescan but is over

generalized, meaningless and should be flatly rejected as nonsense. In the end, if the “equivalent” is

defined to include any of the salient features of the Accused Products, the “equivalent” was not

1 The Patents-in-Suit are U.S. Patent No. 6,153,069 (the “‘069 Patent”) and U.S. Patent No. 6,413,411 (the “‘411 Patent”).

2 The “Accused Products” are the blood glucose monitoring systems sold by Lifescan under the brand name One Touch Ultra.


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disclosed in the prior art references and the applicants did not, therefore, narrow their claims to avoid

a prior art reference that disclosed the “equivalent.”

Defendants’ Motion all but ignores the real question currently before the Court: is there is a

genuine issue of material fact as to whether the rationale giving rise to the applicant’s narrowing

amendments bore no more than a “tangential relationship” to the operation of the Accused Products?

Because the prior art cited during prosecution did not disclose manner in which the Accused

Products operate, the application of the doctrine of equivalent to reach the Accused Products is

determined by the answer to this question. As set forth below, there is certainly a genuine issue of

material fact regarding the rationale for the applicant’s narrowing amendments. Indeed, as

Defendants’ Motion scarcely addresses this decisive issue, Plaintiffs’ respectfully suggest that they

are entitled to summary judgment regarding Lifescan’s prosecution history estoppel defense.

II. BACKGROUND

A. The Parties

Plaintiff PharmaTech develops, markets and distributes affordable medical diagnostic tools

to home users. In and around 2011, Pharma Tech was part of a group that developed a superior,

affordable glucose test strip known as “GenStrip.” The GenStrip was cleared for sale in the United

States by the FDA on November 30, 2012. The GenStrip is compatible with Lifescan’s One Touch

Ultra line of meters and, at the time, the only third-party strip cleared by the FDA for use in

Lifescan’s meters. Lifescan’s One Touch Ultra line of meters and test strips comprises more than

30% of the market for glucose test systems in the United States and provides Lifescan with hundreds

of millions of dollars in revenue annually. The GenStrip threatened Lifescan’s monopoly in the

market for test strips compatible with its meters.

Instead of competing, Lifescan cynically turned to the court system to thwart GenStrip sales

and drown PharmaTech in legal fees. In 2011, fifteen months prior to the GenStrip even being

cleared for sale by the FDA, Lifescan brought a patent infringement action in the Northern District

of California against Pharma Tech and others relating to the GenStrip. Ultimately, PharmaTech

achieved what was essentially a complete defense verdict in the Northern District of California


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action when the parties entered into a settlement to dismiss all claims and Lifescan agreed to pay

PharmaTech money. See Dkt. No. 41 (Declaration of John Shaeffer, Ex. A, Settlement Agreement

and Mutual Release).

PharmaTech’s blood glucose test strips are highly effective and very safe. Contrary to

accusations contained in Lifescan’s Motion, PharmaTech’s test strips are as safe, or safer, than other

test strips in the market. Declaration of Matthew Musho, ¶¶ 4-6. While maintaining high levels of

efficacy and safety, PharmaTech has also priced its GenStrip branded test strips far below

functionally identical strips sold by Lifescan. These test strips have been extremely lucrative for

PharmaTech, which has seen its revenues double from last year to this year.3 Lifescan’s accusation

that PharmaTech’s sales are “de minimus” is utterly baseless. Motion at 3:20-24.

Lifescan’s serial accusations regarding the safety of GenStrip test strips is surprising given

Lifescan’s own track record. Lifescan’s products have been the subject of numerous recalls,4

Lifescan has settled, for tens of millions of dollars, claims that it overcharged Medicare5 and

Lifescan has pled guilty to crimes and paid a $60 million fine for selling defective equipment to

patients (because of which three diabetics allegedly died).6 The Court should ignore Lifescan’s

safety ploy for many reasons, not least of which is it has nothing to do with the claims or defenses in

this lawsuit.

B. The Prosecution History of the ‘069

1. The Claims of the Original Application

The application giving rise to the ‘069 Patent was filed on February 9, 1995. The claims

attached to the original application were broad enough to essentially cover any test strip with two

3 As set forth in the most recent Quarterly Report filed by PharmaTech’s parent company Decision Diagnostics Corp., the company’s revenue nearly doubled from the first six months of 2016 to the first six months of 2017. www.otcmarkets.com/financialReportViewer?symbol=DECN&id=177347.

4 E.g., February 2010 recall of test strips (www.fda.gov/Safety/Recalls/ucm202119.htm); March 2013 recall of meters (www.fda.gov/medicaldevices/safety/listofrecalls/ucm349127.htm).

5 See www.justice.gov/sites/default/files/civil/legacy/2014/04/18/LifeScan, %20%20%20et%20al.%202000.pdf.

6 See www.nytimes.com/2000/12/16/business/guilty-plea-by-division-of-drug-giant.html.


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electrodes. Declaration of Dr. Joseph Wang (“Wang Decl.”), Ex. A (Expert Report) at ¶ 20.7 In an

Office Action dated March 21, 1997, the examiner rejected the claims with reference to prior art that

also featured two working electrodes. See ‘069 Prosecution History at 069PH_00000114-123.8 The

examiner cited U.S. Patent No. 5,385,846 to Kuhn (“Kuhn”), U.S. Patent No. 5,288,636 to Pollman

(“Pollman”) and U.S. Patent Nos. 5,108,564 (“Szuminsky ‘564”). The examiner noted that each of

these references disclosed a system with two electrodes. Notably, the examiner did not cite U.S.

Patent No. 5,243,516 (“White”).

2. Amendment to Include a “Linear Comparison” Limitation

On October 27, 1997, the applicant responded to the rejection with a Response to Office

Action. ‘069 Prosecution History at 069PH_00000124-134. The applicant amended certain claims

(4, 17, 66-69) and cancelled the rest. In amending Claim 4, the applicant added a requirement that

the system convert the current readings taken from the two electrodes into blood glucose readings

and “linearly compar[e]” the results. ‘069 Prosecution History at 069PH_00000126-127.

The applicant distinguished Kuhn, Pollman and Szuminsky ‘564 in light of the

aforementioned amendments. ‘069 Prosecution History at 069PH_00000131-134. The applicant

argued that the amended Claim 4 overcame Kuhn because it now required multiple readings, taken at

different times, which were then “linearly compared.” ‘069 Prosecution History at

069PH_00000131. Instead, as noted by the applicant, Kuhn disclosed a system that “obtain[ed] a

plurality of readings by taking repeated measurements.” Id. The applicant noted that the

amendments overcame Pollman because Pollman did not disclose the invention where “the current is

measured at least two different times during the same measurement.” ‘069 Prosecution History at

7 Lifescan’s Motion blithely asserts that the report served by Plaintiffs’ technical expert, Dr. Joseph Wang, contained “conclusory assertions.” This is simply not true. Dr. Wang’s report contained ample support for all of the conclusions set forth therein. See Wang Declaration, Ex. A (Expert Report). Further, Lifescan had the opportunity to – and did in fact – examine Dr. Wang under oath in a deposition and ask questions regarding the bases for his opinions. Tellingly, Lifescan’s Motion does not assert that Dr. Wang’s opinions – as expressed during his deposition – lacked support.

8 All references to the ‘069 Prosecution History refer to the document attached as Exhibit 3 to the Declaration of Eugene Gelernter in Support of Defendants’ Motion for Summary Judgment, Dkt. No. 67 (“Gelernter Declaration”). All references to the ‘411 Prosecution History refer to the document attached as Exhibit 4 to the Gelernter Declaration.


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069PH_00000131-132. The applicant continued: “Pollman likewise does not suggest the present

claimed means for comparing the concentration derived from the first measurement and at least one

additional concentration derived from an additional measurement to verify the results.” Id. The

applicant noted that the Pollman disclosure was limited to a system that taught “measuring Cottrell

(diffusion limited) current.” Id.

The applicant also distinguished Szuminsky ‘564 on the grounds that the claimed invention

“verif[ies] the result by comparing concentrations determined at different times during the

measurement.” ‘069 Prosecution History at 069PH_00000132. The applicant’s October 27, 1997,

Response did not cite White or attempt to distinguish White. ‘069 Prosecution History at

069PH_00000124-134. That reference was not one of the three prior art references that was relied

upon by the examiner to reject the original, broad claims. Id.

Lifescan’s Motion asserts that the addition of the “linearly compare” limitation – the first

amendment “made in response to the first substantive action by the PTO during prosecution” – is the

“relevant” amendment. Motion at 14:11-12. Lifescan furthermore asserts that the language was

“fine-tuned” in subsequent amendments but that “[t]hese later amendments are not the basis for

Lifescan’s assertion of prosecution history estoppel.” Id., at 15:14 and fn. 8.

This applicant’s amendment did not surrender any ground. In truth, this first amendment,

which is the centerpiece of Lifescan’s prosecution history estoppel argument, was futile and

meaningless. The “linearly compare” amendment did not result in the issuance of a patent and was

not included in the claims that did issue. Quite simply, the phrase had no meaning and was not

supported in the specification, as noted by the examiner. The proposed amendment was rejected in

an Office Action dated July 2, 1998. ‘069 Prosecution History at 069PH_00000137-142. The

examiner commented: “Is the comparing done by human eyes? If not, what hardware is used and

where is the supporting disclosure for it? In as much as this is a key distinction over prior art, in

must be clearly set forth.” ‘069 Prosecution History at 069PH_00000138. The examiner rejected

the claims under 35 U.S.C. § 112, first paragraph. Id.

As the examiner noted, the meaning of the proposed term “linear comparison” was unclear.

Lifescan’s own technical expert agreed. Declaration of Jeff Grant (“Grant Decl.”), Ex. A (Transcript


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from Deposition of John Smith (“Smith Depo.”)) at 77:12-18. At this point in the prosecution,

before the applicant clarified what “linear comparison” meant by substituting the term with more

specific language, even people having ordinary skill in the art could not know what the term meant.

Id., at 76:6-24. In other words, the centerpiece amendment of Lifescan’s assertion of prosecution

history estoppel meant nothing then and estops nothing now.

The subsequent amendments were not mere “fine-tun[ing].” Later amendments, including

those proposed on September 27, 1997, rectified the claims so that they were understandable,

supported by the specification, and patentable.

In any event, even if the amendment to add the “linearly compare” limitation was the

“relevant” amendment (it is not), subsequent statements made during prosecution – particularly

statements distinguishing the proposed claims from the prior art – can help shed light onto the reason

for the amendment. This is especially the case here, where the addition of the “linearly compare”

limitation was not understood by the examiner and did not find any support in the specifications. In

these circumstances, it is entirely appropriate to look to subsequent prosecution history to give this

amendment meaning.

3. Amendments to Rephrase the “Linear Comparison” Limitation

In a September 28, 1998, Response and Amendment, the applicant responded by amending

its proposed claims to specify that a “microprocessor” was the hardware doing the comparisons, and

further arguing that the specification described the concept of a “linear comparison.” ‘069

Prosecution History at 069PH_00000145-154. In responding to the examiner’s 35 U.S.C. § 102(b)

and 103 rejections, the applicant asserted that Szuminsky did not teach taking multiple

measurements at different times and linearly comparing the results:

Szuminsky . . . states only that the device measures the current at specific time points during the Cottrell current decay, and that these current values are then used to calculate the analyte concentration which is then displayed. There is absolutely no basis for concluding that the Szuminsky reference teaches one to linearly compare multiple measurements in order to verify accuracy of the test being conducted.

‘069 Prosecution History at 069PH_00000153.


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In an Office Action dated November 6, 1998, the examiner wrote that the specification does

not describe the concept of performing a “linear comparison,” such that the proposed claims still

failed under 35 U.S.C. § 112, first paragraph, which requires a full written description of the

invention in the specification.9 ‘069 Prosecution History at 069PH_00000159-160. The examiner

noted that the microprocessor described in the specifications performed the step of controlling the

timing of the signals, not “linearly comparing” test results. Id. The examiner also rejected the

claims in light of Szuminsky under 35 USC §§ 102(b) and 103(a). ‘069 Prosecution History at

069PH_00000161-162. The examiner noted that “[w]hether Szuminsky teaches comparing multiple

measurements to verify redundancy is really not significant so long as he discloses the hardware

capable of performing the comparison.” ‘069 Prosecution History at 069PH_00000161. The

examiner noted that the decision rejecting the claims was final.

On February 5, 1999, concurrently with filing of a Continued Patent Application, the

applicant filed a Preliminary Amendment. ‘069 Prosecution History at 069PH_00000170-178. The

applicant added as a limitation to all of the claims the requirement that the surface area of the

counter, or reference electrode be no larger than the surface area of the working electrode. ‘069

Prosecution History at 069PH_00000170-173. The Applicant also argued against the obviousness

rejection in light of Szuminsky: “the act of taking multiple measurements does not render the linear

comparison of those measurements to check for errors obvious to one of ordinary skill in the art.”

‘069 Prosecution History at 069PH_00000177. The applicant also noted that, in White, the

reference disclosed comparing measurements “using a non-linear comparison of multiple

measurements.” Id.

In an Office Action dated March 26, 1999, the examiner rejected the proposed claims as

unpatentable in light of Szuminsky, Walling and/or White. ‘069 Prosecution History at

069PH_00000180-184. The examiner noted that, while the references may not disclose “linearly

comparing,” the claims are directed to an apparatus such that it was irrelevant as to whether the prior

9 Congress relabeled the first paragraph of this statute as section (a) in the America Invents Act. 35 U.S.C. § 112(a).


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art performed the function. ‘069 Prosecution History at 069PH_000001183. The examiner also

noted that the application failed to adequately disclose what “linear comparing” actually means. Id.

In an Amendment dated September 27, 1999, the applicant added the following language:

means for converting the first Cottrell current reading into a first analyte concentration measurement using a calibration slope and an intercept specific for the first Cottrell current measurement for converting the at least one additional Cottrell current reading into an additional analyte concentration using a calibration slope and an intercept specific for the at least one additional Cottrell current measurement, and for comparing the first analyte concentration measurement with the at least one additional concentration measurement to confirm that they are within a prescribed percentage of each other.


In the Remarks section, the patentee argued that the amended claims were patentable over the

prior art. ‘069 Prosecution History at 069PH_00000198-201. The applicant noted that Walling and

Szuminsky do not disclose taking multiple analyte concentration measurements and comparing the

measurements “to confirm proper operation of a measuring system.” ‘069 Prosecution History at

069PH_00000199. The applicant noted that White did disclose taking multiple Cottrell

measurements but that White “confirms the Cottrell current readings are proper by evaluating the

inverse ratio of the times square roots of the Cottrell current readings.” ‘069 Prosecution History at

069PH_00000200. The applicant noted:

White differs from the present invention in that White confirms that the Cottrell current readings are proper by evaluating the inverse ratio of the times square roots of the Cottrell current readings. See White at column 4, line 52 – column 5, line 25, and specifically at column 5, lines 12-14.


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There, the White reference notes the following:

Gelernter Declaration, Ex. 26.

As described in this equation, the system described in White measured current readings and

time, calculated a ratio based on those current reading measurements, calculated the square root of

time, created a ratio based on the square root of time, and compared (a) the ratio of the currents to

(b) the ratio of the square root of time.

The methodology in White is very different from the claimed invention. The applicant relied

on these differences to overcome that reference:

Thus, White discloses determining whether a Cottrell current reading is proper by a complicated mathematical inverse ratio of the times square root. In contrast to the teachings in White the present invention compares analyte concentration readings at different times. As that feature of the present invention is neither taught nor suggested by White the teachings in White cannot overcome the deficiencies in Walling et al with respect to such subject matter.


In a November 19, 1999 Office Action, the examiner issued a final rejection. The examiner

rejected the claims as unpatentable over Walling in view of White. ‘069 Prosecution History at

069PH_00000202-206. The examiner argued that, while White compared the readings in a non-

linear fashion, White nevertheless compared the readings. ‘069 Prosecution History at


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069PH_00000205. The examiner rejected the applicant’s argument that White should be

distinguished on the grounds that it compared readings using a “complicated mathematical inverse

ratio of the times square root”:

This argument is not persuasive. It is clear that White takes current readings at succeeding times (col. 4, line 60). While White compares the readings to determine whether a proper Cottrell current reading by an inverse ratio of the times square root, it nevertheless compares the current readings to determine whether it is proper. Thus, White has a narrow, specific means for comparing the readings to determine its propriety, while applicant claims broad means for comparing the readings to determine its propriety. A broad means can not define over a narrow means.


The examiner granted an interview, which was conducted on May 12, 2000. ‘069

Prosecution History at 069PH_00000232. During that interview, the examiner “tentatively indicated

that the pending claims would be allowable” in light of comments made by the applicant during the

interview. ‘069 Prosecution History at 069PH_00000216. In the May 12, 2000 Amendment, the

applicant proposed changes to the language in the specifications, but not the claims. ‘069

Prosecution History at 069PH_00000214-215.

The applicant distinguished White as follows:

More specifically, White (‘516) discloses an operation in which Cottrell current measurements at two different times are taken and a ratio of the measured Cottrell currents are evaluated. That operation in White (‘516) differs from the present invention in the following respects. First, in the present invention the two different Cottrell current readings are converted into first and second analyte concentration measurements. Further, in the present invention the first and second analyte concentration measurements based on the first and second current readings are compared to each other to confirm that they are within a prescribed percentage of each other. That operation in the present invention is neither performed nor suggested by the teachings of White (‘516). In contrast to the present invention, in White (‘516) a ratio of measured Cottrell currents are evaluated, and this White (‘516) does not disclose or suggest comparing first and second analyte concentration measurements based on first and second Cottrell current readings to each other.

‘069 Prosecution History at 069PH_00000219-220.

As reflected in this response, White evaluates an inverse ratio of the times square roots of the


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Cottrell current readings, while the proposed claims were directed to a linear comparison of multiple

measurements.

In its Motion, Lifescan cites various instances in which the applicant pointed out that the

proposed claims were directed to a system that compares analyte concentrations. Motion at 17:7-23.

However, notably absent from Lifescan’s Motion is any statement by the applicant that the proposed

claims did not or could not be directed to current measurements. No such statement exists. Further,

in none of the instances touted by Lifescan does the applicant suggest that its system can only work

by comparing analyte concentrations.

C. The Prosecution History of the ‘411 Patent

The application that gave rise to the ‘411 Patent was filed on October 26, 2000. It was a

continuation of the application that gave rise to the ‘069 Patent. Gelernter Declaration, Dkt. No. 67,

Ex. 2. The ‘411 Patent has the same specification as the ‘069 Patent. Id. The ‘411 Patent issued on

July 2, 2002 after only one office action. Id., Ex. 4. As a continuation of the application giving rise

to the ‘069 Patent, the analysis of the doctrine of equivalents regarding the ‘411 Patent is the same as

the analysis under the ‘069 Patent. As with the ‘069 Patent, Plaintiffs are not estopped from

asserting infringement of the ‘411 Patent against the Accused Product in accordance with the

doctrine of equivalents.

III. LEGAL STANDARD

A. Standard On Summary Judgment

In deciding a motion for summary judgment, the movant bears the burden of showing the

absence of any genuine issue of material fact that would preclude judgment in the movant’s favor.

Fed. R. Civ. P. 56. “To support a summary judgment of noninfringement it must be shown that, on

the correct claim construction, no reasonable jury could have found infringement on the undisputed

facts or when all reasonable factual inferences are drawn in favor of the patentee.” Netword, LLC v.

Central Corp., 242 F.3d 1347, 1353 (Fed. Cir. 2001).

Patent infringement is a fact-intensive inquiry, particularly when it implicates the doctrine of

equivalents. “Because infringement under the doctrine of equivalents often presents difficult factual

determinations,” summary judgment often is not appropriate. Leggett v. Platt, Inc. v. Hickory


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Springs Mfg. Co., 285 F.3d 1353, 1360 (Fed. Cir. 2002). This is because “a court’s function [on

summary judgment] is not to weigh the evidence and determine the truth but to determine whether

there is a genuine issue for trial.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986). The

court must draw all reasonable factual inferences in the non-movant’s favor, and “the evidence of the

nonmovant is to be believed.” Id. at 255; Graver Tank & Mfg. Co. v. Linde Air Products Co., 339

U.S. 605, 609–10 (1950) (“A finding of equivalence is a determination of fact.”).

Lifescan seeks to rely on amendment-based and argument-based prosecution history estoppel

as a defense against infringement under the doctrine of equivalents. To establish amendment-based

estoppel, Lifescan bears the initial burden of establishing that the “equivalent” – i.e., Accused

Product – falls within ground that was surrendered in an amendment made during prosecution.

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1366 (Fed. Cir. 2003) (en

banc) (hereinafter, “Festo IX”). Such a showing creates a presumption that the doctrine of

equivalents cannot reach the accused products. Id. However, the patentee (here, Plaintiffs) can

rebut the presumption by, inter alia, showing that the equivalent was no more than “tangentially

related” to the reasons for the narrowing amendment. Festo Corp. v. Shoketsu Kinzoku Kogyo

Kabushiki Co., Ltd., 535 U.S. 722, 740 (2002) (hereinafter, “Festo VII”). These inquiries are highly

fact intensive. See Peter Lee, Patent Law And The Two Cultures, 120 Yale L.J. 2, 49 (2010))

(“rebutting the presumption of prosecution history estoppel requires a deep examination of

technological facts”).10

Courts routinely refuse to grant an accused infringer summary judgment on amendment-

based prosecution history estoppel where there are disputed issues of fact. Monolithic Power

Systems, Inc. v. O2 Micro Intern. Ltd., 476 F.Supp.2d 1143, 1152 (N.D. Cal. 2007) (“[T]here is a

disputed issue of fact as to whether [patentee’s] amendment bears only a tangential relationship to

the equivalents at issue. Therefore, the Court denies summary judgment that [patentee] is precluded

from asserting the doctrine of equivalents.”); Henrob Ltd. v. Bollhoff Systemtechnick GmbH & Co.,

10 While, as Lifescan notes, the tangential relationship exception is sometimes referred to as “very narrow,” the facts in this case fit easily within the exception, whatever shape it may be. Motion at 11:27-28.


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2009 WL 3199825, at *13 (E.D. Mich. Sept. 29, 2009) (denying accused infringer’s summary

judgment motion regarding prosecution history estoppel and noting that the accused infringer can

“revisit” the issue “in the form of a motion for judgment as a matter of law, at the close of the

evidence and after the jury verdict, as specifically sanctioned by the Federal Circuit”); VDP Patent,

LLC v. Welch Allyn Holdings, Inc., 2007 WL 14609, at *2 (S.D.N.Y. Jan. 2, 2007) (denying

summary judgment and noting that “equivalence ordinarily would be an intensely factual question”).

As set forth below, Lifescan’s Motion should be denied.11

B. Prosecution History Estoppel Does Not Apply Where An Amendment Bears No

More Than A Tangential Relation To The Equivalent In Question

As the Supreme Court in Festo VIII explained, “[t]here is no reason why a narrowing

amendment should be deemed to relinquish equivalents . . . beyond a fair interpretation of what was

surrendered.” Id. at 737-38. The Festo VIII Court thus established a tangentiality exception to

prosecution history estoppel:

There are some cases . . . where the amendment cannot reasonably be viewed as surrendering a particular equivalent . . . . [T]he rationale underlying the amendment may bear no more than a tangential relation to the equivalent in question . . . . In those cases the patentee can overcome the presumption that the prosecution history estoppel bars a finding of equivalence.

535 U.S. at 740-41. The determination of whether the tangentiality exception applies “focuses on the

patentee’s objectively apparent reason for the narrowing amendment” and on the “context in which

the amendment was made.” Festo IX”, 344 F.3d at 1369-70. The exception applies, therefore, when

“the reason for the narrowing amendment was peripheral, or not directly relevant” to the equivalent

11 In a cheap mudslinging exercise, Lifescan’s Motion asserts that Plaintiffs’ literal infringement claims – which are not at issue in Lifescan’s Motion – were “baseless.” Motion at 8, fn 6. However, Lifescan has no one but itself to blame. As extensively detailed in Plaintiffs’ Opposition to Lifescan’s Motion to Dismiss, Dkt. No 39, Plaintiffs’ literal infringement case was solidly founded upon, among many other things, the unequivocal statements from Alex Gorsky. In statements to Johnson & Johnson’s shareholders, Mr. Gorsky essentially stated that the Accused Products practice the literal claims of the Patents-in-Suit. At the time of the statement, Gorsky was Lifescan’s Worldwide Chairman of the Medical & Diagnostics Group. He is now Johnson & Johnson’s CEO and Chairman of the Board. Further still, Smith, Lifescan’s own expert, stated in a sworn declaration, filed with the USPTO that Lifescan’s Accused Products operated in an infringing manner. Smith Depo. at 137:5-139:18. While Plaintiffs’ have since dismissed their literal infringement claims, those claims were very well supported.


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in question. Id. at 1369.

The tangentiality exception created by the Supreme Court’s Festo VIII reflects a departure

from then-existing Federal Circuit precedent. In Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki

Co., Ltd., 234 F.3d 558, 569 (Fed. Cir. 2000) (“Festo I”), which was vacated by Festo VIII, the

Federal Circuit held that an amendment made for the purposes of patentability precluded any future

application of the doctrine of equivalents. Festo I held that, “[w]hen a claim amendment creates

prosecution history estoppel with regard to a claim element, there is no range of equivalents

available for the amended claim element. Application of the doctrine of equivalents to the claim

element is completely barred (a “complete bar”).” The Supreme Court’s Festo VIII decision

reversed Festo I and rejected the harsh “complete bar” in favor of the more nuanced approach of the

tangentiality exception.

Several recent cases illustrate the exception described in Festo VIII. In Intervet Inc. v. Merial

Ltd., the Federal Circuit found the tangentiality exception applied to an amendment to a claim for

DNA segments that added a limitation requiring the segments to be “of porcine circovirus type II

(‘PCV-2’).” 617 F.3d 1282, 1291 (Fed. Cir. 2010). The addition of the “of porcine circovirus type

II” limitation overcame prior art by limiting the claim so that it did not generally cover DNA

sequences “from any organism.” Id. Based on that narrowing amendment, the district court

precluded the patentee from asserting the doctrine of equivalents with respect to any DNA

sequences, including porcine circovirus sequences, not qualifying as PCV-2. But the Federal Circuit

found the scope of the district court's bar on the doctrine of equivalents to be “overly broad” and

reversed that “draconian preclusion.” Id. at 1290, 1292. The court noted: “The scope of the estoppel

must fit the nature of the narrowing amendment. A district court must look to the specifics of the

amendment and the rejection that provoked the amendment to determine whether estoppel precludes

the particular doctrine of equivalents argument being made.” Id. at 1291. The court reasoned that

while the patentee could not argue that sequences derived from non-porcine circoviruses are

equivalent to PCV-2 because excluding non-porcine sequences was the reason for the amendment,

that amendment “bore only a tangential relation to the question of which DNA sequences are and are

not properly characterized as PCV-2.” Id. at 1292. The court held, therefore, that the district court


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unfairly precluded the patentee from reaching as equivalents porcine segments lacking the specific

combinations of nucleotides literally required by the PCV-2 limitation. Id.

Similarly, in Regents of the University of California v. Dakocytomation California, Inc., the

claim at issue was amended to add a “method of blocking” to overcome the prior art. 517 F.3d 1364,

1378 (Fed. Cir. 2008). The Federal Circuit held that specifying the use of “blocking nucleic acid”

was tangential to the rationale for the amendment, so the district court erred in precluding the

patentee from asserting the doctrine of equivalents against a method that used a different type of

blocking material. Id. Because “none of the cited references concerned the type of nucleic acid that

could perform the blocking,” the court concluded that the “the amendment did not surrender the

equivalent in question because the narrowing amendment was only tangential to [the equivalent in

question].” Id.

In Insituform Technologies, Inc. v. CAT Contracting, Inc., 385 F.3d 1360 (Fed. Cir. 2004),

the claim at issue covered a method for applying resin to a tube liner using a single vacuum cup

applied at multiple points along the liner. That claim included multiple limitations originally recited

as dependent claims, including the requirement that there be a single vacuum cup applied at multiple

locations. 385 F.3d at 1369. The accused process used multiple cups at multiple locations, so it

could only infringe if the use of multiple cups could be reached under the doctrine of equivalents.

The reason for the amendment, however, was to overcome a prior art process that used a vacuum

source fixed at a single, disadvantageous location. Id. at 1370. That reason was only tangentially

related to whether multiple vacuum cups were used; there was “no indication in the prosecution

history of any relationship between the narrowing amendment and a multiple cup process.” Id.

Because the accused process differed from the claim only in the number of vacuum cups used, as

opposed to their location, the Federal Circuit affirmed the district court’s judgment permitting the

patentee to assert infringement by equivalence. Id. at 1370-71.12

12 Lifescan’s Motion repeatedly notes that Plaintiffs did not previously press infringement under the doctrine of equivalents. Motion at 7:6-8, 8:6-8. Lifescan argues by innuendo that infringement under that doctrine must not, therefore, exist. Lifescan’s assumptions are unsupported and plainly mistaken. While Plaintiffs did not originally stress infringement under the doctrine of equivalents, subsequent analysis and discovery has revealed that the Accused Products squarely infringe under this theory.


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As set forth below, Lifescan’s Motion presupposes an alternative reality where the Supreme

Court did not overturn the Federal Circuit’s Festo I. The thrust of Lifescan’s argument is that

Plaintiffs surrendered the ability to assert literal infringement of the Accused Products when they

proffered a narrowing amendment. However, in light of the Supreme Court’s Festo VIII, that does

not – by any measure – end the analysis. Now, “[t]here is no reason why a narrowing amendment

should be deemed to relinquish equivalents . . . beyond a fair interpretation of what was

surrendered.” Festo VII at 737-38. No fair interpretation of what was surrendered included the

Accused Products.

C. Argument-Based Estoppel Requires a “Clear and Unmistakable” Surrender of

the Subject Matter

Prosecution history estoppel can also occur where an applicant surrenders “claim scope

through argument to the patent examiner (‘argument-based estoppel’).” Voda v. Cordis Corp., 536

F.3d 1311, 1325 (Fed. Cir. 2008). “[A]n applicant can make a binding disavowal of claim scope in

the course of prosecuting the patent, through arguments made to distinguish prior art references.

Such argument-based disavowals will be found, however, only if they constitute clear and

unmistakable surrenders of subject matter.” Cordis Corp. v. Medtronic Ave, Inc., 511 F.3d 1157,

1177 (Fed. Cir. 2008) (emphasis added).

There is a very heavy burden associated with establishing prosecution history estoppel. See,

e.g., Deering Precision Instruments, L.L.C. v. Vector Distribution Systems, Inc., 347 F.3d 1314,

1326–27 (Fed. Cir. 2003) (district court erred in finding amendment-based estoppel as there was no

clear and unmistakable surrender); Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1363 (Fed.

Cir. 2003) (same); Eagle Comtronics, Inc. v. Arrow Communication Laboratories, Inc., 305 F.3d

1303, 1316 (Fed. Cir. 2002) (same). Equivocal statements cannot result in the imposition of

amendment-based estoppel. Schwing GmbH v. Putzmeister Aktiengesellschaft, 305 F.3d 1318, 1327

(Fed. Cir. 2002) (vacating summary judgment where statement was equivocal). Statements must be

viewed in context with all of the prosecution history. Read Corp. v. Portec, Inc., 970 F.2d 816 (Fed.

Cir. 1992), overruled on other grounds by Markman v. Westview Instruments, Inc., 52 F.3d 967, 975

(Fed. Cir. 1995).


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IV. ARGUMENT

A. The Operation Of The Accused Products (Aka The Equivalent) Was Not

Disclosed In The Prior Art

1. The Prior Art Does Not Disclose the Actual Equivalent

The rationale behind the applicant’s amendment bore no relationship, and certainly no more

than a tangential relationship, to the Accused Products. In tacit recognition of that fact, Lifescan’s

brief asserts (incorrectly) that the prior art that gave rise to one or more of the amendments contained

an “equivalent” not previously disclosed by Lifescan or set forth in the report signed by Lifescan’s

technical expert. Resting on the newly minted, grossly oversimplified “equivalent,” Lifescan seeks

to avail itself of the rule that the tangential relationship exception set forth in Festo VII is not

available where the amendment is made to avoid prior art that contains the “equivalent” (i.e., the

Accused Products). Integrated Tech. Corp. v. Rudolph Techs., Inc., 734 F.3d 1352, 1358 (Fed. Cir.

2013) (tangential relationship doctrine is not available where an amendment is made to avoid prior

art that contains the “equivalent”).

Lifescan’s assertions fail. In accordance with the doctrine of equivalents, the “equivalent” is

simply the Accused Product. Lifescan does not and cannot assert that the operation of the Accused

Product was disclosed in the prior art. Lifescan’s attorneys have outlined how the Accused Products

function. As set forth in on page three of a May 24, 2016 letter written by Lifescan’s counsel of

record, Gregory Diskant,13 the Accused Products have two working electrodes (and one common

“reference” electrode). A sample (blood) is deposited on the electrodes. The Accused Products then

take a current measurement from the first working electrode at a first time and then from the second

working electrode and a second time. In other words, the Accused Products take two different

current reading measurements from two different working electrodes at two different times:

13 A copy of that letter is attached as Exhibit 5 to the Declaration of Anthony DeCinque In Support of Defendants’ Motion to Dismiss (“DeCinque Declaration”), Dkt. No. 35-5.


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Dkt No. 35-5 (DeCinque Declaration, Ex. 5) at 4. This graph, which was set forth in Lifescan’s May

24, 2016, letter, reflects the fact that the Accused Products have two working electrodes (WE1 and

WE2) that measure currents at two different times (WE1 Final and WE2 Final). Thereafter, the

Accused Products use those results and perform the following calculations (results are denoted as

“CorrectedFCV,” which reflects a reading that has been corrected for background interference):

Dkt No. 35-5 (DeCinque Declaration, Ex. 5) at 4.

None of the prior art cited during the prosecution of the Patents-in-Suit discloses these

operations. None of the prior art discloses a system with two working electrodes where a current

reading is taken from each electrode at a different time. Wang Decl. ¶ 3. None of the prior art

performs the analysis of those readings (taken from two electrodes at different times) as set forth in

the figure above. Therefore, the discussion concerning whether the “equivalent” – i.e., the Accused

Products – is contained in the prior art should stop here.


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In attempt to salvage the argument, however, Lifescan’s attorneys have attempted to redefine

the “equivalent,” as if the “equivalent” has some importance or purpose other than being the label

applied to the Accused Product for the purposes of performing a doctrine of equivalents analysis.

Lifescan’s attempted sleight of hand, however, broke down during discovery.

There were various formulations of the “equivalent” proposed during discovery. In

Lifescan’s May 24, 2016, letter, Lifescan defined the “equivalent” (i.e., the Accused Product) as a

system with two working electrodes that takes a current measurement with each of the two working

electrodes at different times, compares the results and converts those results to glucose readings.

Dkt No. 35-5 (DeCinque Declaration, Ex. 5) at 3-4. Plaintiffs incorporated that definition of the

“equivalent” in their operative pleading. In their First Amended Complaint, Plaintiffs described the

equivalent in their First Amended Complaint as a system that “(a) measures current at two different

times, (b) compares the currents to ensure that they are within a prescribed percentage, and (c)

converts the current readings into glucose concentration.” Dkt. No. 49-5 (First Amended Complaint,

Ex. E) at 5-6. Smith relied upon this language in his expert report. Motion, Dkt. 67, Ex. 5 (Smith

Declaration, Ex. A (Smith Report)) at ¶ 79. Plaintiffs also incorporated by reference Lifescan’s May

24, 2016 definition of the equivalent: “The prosecution history of the Patents-in-Suit establish that

the Plaintiffs never abandoned their right to assert the doctrine of equivalents on the system

described by Defendants’ counsel in its May 24, 2016 letter.” Dkt. No. 49-5 (First Amended

Complaint, Ex. E) at 3. Smith did not adopt the definition of the equivalent proposed by Lifescan’s

litigation counsel. Plaintiff’s expert, Joseph Wang, discussed the equivalent by reference to

Lifescan’s May 24, 2016, letter and also similarly described the “equivalent” as “(a) measures

current from two different electrodes, (b) compares the current to ensure they are within a prescribed

percentage and (c) converts the current readings into a glucose concentration.” Wang Decl., Ex. A,

¶¶ 17-18.

The record establishes, conclusively, that none of the aforementioned “equivalents” were

disclosed in any of the prior art references cited during the examination of the Patents-in-Suit.

Lifescan now distances itself from its own definitions of the equivalent. In its Motion,

Lifescan now proposes a new “equivalent” that merely takes multiple current readings and performs


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a “safety check.” See, e.g., Motion at 23:27-24:25, 25:2-4, 26:9-11 (“the reason for the amendment

and the alleged equivalent in this case both involve the same aspect of the claimed invention, i.e.,

making a comparison for the purposes of performing a safety check”). This is a gross

oversimplification of how the Accused Product operates. It also overlooks, entirely, the significant

differences in how blood glucose measuring devices function. None of the prior art references

disclose how the Accused Products operate.

Lifescan’s Motion argues that the applicant “limited their claims to what they said they had

invented: a system that performs a safety check by comparing analyte concentrations, not current

readings.” Motion at 13:12-14 (emphasis supplied). This is false. Nowhere in the prosecution

history did the applicant characterize their invention as Lifescan has argued. The applicant touted,

as is routine in patent prosecution, all of the aspects of the invention as being not found in prior art.

However, the applicant never disclaimed using current readings as opposed to analyte

concentrations. Notably absent from Lifescan’s Motion is any authority for the novel assertion that

amendments and arguments that are silent as to a feature constitutes an abandonment of that feature.

Silence does not estop.

2. Lifescan’s Expert Concedes That the Prior Art Did Not Disclose the

Elements of the “Equivalent” That Lifescan’s Expert Adopted

The report signed by Lifescan’s technical expert, John Smith, posits an “equivalent” of a

system that (a) measures current at two different times, (b) compares the measured current to

ascertain whether the readings are within a prescribed range, and (c) converts the current readings

into an analyte or glucose readings. Motion, Dkt. No. 67, Ex. 5 (Smith Declaration, Ex. A) at ¶ 79.

The report concludes that this “equivalent” was present in the prior art. However, Smith conceded at

his deposition that none of the prior art cited during the prosecution disclosed these elements.

Smith’s expert report asserted it was known in the prior art cited by the examiner that

“glucose concentration measurements could be verified by comparing currents taken at different

times during the measurement process.” Motion, Dkt. No. 67, Ex. 5 (Smith Declaration, Ex. A) at ¶

22. This and other similarly conclusory assertions were completely debunked during discovery.

Under cross-examination, Smith testified that none of the references make such a disclosure. Smith


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forthrightly agreed that neither Pollman, Nankai, Szuminsky ‘564, Szuminsky ‘015 nor Kuhn

disclose a system that compares current readings taken at different times. Grant Decl., Ex. A (Smith

Depo.) at 8:25-12:3, 13:9-21, 70:25-72:25; Motion, Dkt. No. 67 (Smith Declaration, Ex. A (Smith

Report)) at ¶ 22. Similarly, after thoroughly reviewing the Walling reference, Smith testified that he

could not say whether Walling made that disclosure. Grant Decl., Ex. A (Smith Depo.) at 19:25-

21:17; 22:15-24.

Smith also conceded that the White reference did not directly correspond to the “equivalent”

set forth above. Grant Decl., Ex. A (Smith Depo.) at 31:12-32:2; 34:12-25, 48:7-23. Smith testified

that White’s system, which is detailed in the specification of the White patent as Equation No. 5,

does not compare the currents to ensure that they are within a prescribed percentage or convert those

current readings into glucose readings. Id. at 34:12-25. Smith further noted that White does not

disclose two working separate electrodes. Id., at 32:6-11.

Smith went further and distinguished White from the operation of the Accused Product itself.

The operations disclosed by White and the operation of the Accused Product are as follows:

White Equation No. 5

(U.S. Patent No. 5,243,516)

The Equivalent

(Accused Product)14

14 Dkt No. 35-5 (DeCinque Declaration, Ex. 5) at 4.


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Smith testified that “the current values in an Ultra system are not the same as the current

values in the White Patent. They’re not from the same circumstances. They’re not intended to be

derived the same way.” Grant Decl., Ex. A (Smith Depo.) at at 58:6-14. When asked whether one

could substitute the White formula into the Accused Product, Smith testified that “the variables

shown in White equation 5 are different from the terms that are shown in [the Accused Product].

They don’t coincide.” Id., at 59:1-8. He further noted that “[e]quation 5 in White has four variables,

and your equation has two variables so, therefore, they’re not equivalent.” Id., at 63:15-25. While

Smith originally stood on conclusory assertions that the amendments were directly related to the

equivalent, Smith was forced to admit the opposite under cross-examination. Motion, Dkt. No. 67,

(Smith Declaration, Ex. A (Smith Report)) at ¶¶ 22, 24, 81, 111, 133.

3. Lifescan’s Motion Abandons an Analysis of the Accused Product as the

Equivalent and Instead Focuses on Irrelevant, Generic Similarities

Lifescan could not argue in good faith that the prior art disclosed either the elements of the

Accused Products or the elements of the “equivalent” adopted by Smith. Motion, Dkt. No. 67,

(Smith Declaration, Ex. A (Smith Report)) at ¶ 79. While Lifescan’s Motion repeatedly references

an “equivalent,” Lifescan’s Motion notably fails to clearly define “equivalent.” Indeed, while

Lifescan’s Motion offers the Court little more than obfuscation, its tortured definition is the lynchpin

of Lifescan’s entire Motion. Resolving this confusion reveals a Motion that is fatally flawed.

During discovery, Lifescan defined the “equivalent” as a system that (a) measures current at


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two different times, (b) compares the measured current to ascertain whether the readings are within a

prescribed range, and (c) converts the current readings into an analyte or glucose readings. See

Motion, Dkt. No. 67, (Smith Declaration, Ex. A (Smith Report)) at ¶ 79. However, as set forth

above, none of the prior art referenced during the prosecution disclosed such a system.

Lifescan was forced to morph the definition of “equivalent” posited by Smith to a

significantly more broad and generic definition to facilitate Lifescan’s litigation position that the

equivalent could be found in the prior art. Lifescan’s newly concocted definition of the equivalent,

set forth obliquely for the first time in its Motion, is apparently a system that takes multiple current

measurements and performs a “safety check” to verify accuracy. See, e.g., Motion at 23:27-24:25,

25:2-4, 26:9-11. Lifescan’s new definition of equivalent sweeps under the rug the vastly different

mechanisms used by the various references.

With its newly concocted definition in hand. Lifescan’s Motion asserts that White “is

identical to the allegedly equivalent OneTouch system in all relevant aspects.” Motion at 23:28-

24:1. Lifescan argues that both White and the “equivalent” feature a “pair of electrodes” that take

multiple current measurements. Id., at 24:1-3. Lifescan also argues that both White, and Lifescan’s

tortured version of the “equivalent” “perform safety checks” before calculating an analyte

concentration. Id., at 24:20-25, 26:9-11 (“the reason for the amendment and the alleged equivalent

in this case both involve the same aspect of the claimed invention, i.e., making a comparison for

purposes of performing a safety check.”). In other words, Lifescan latches onto over simplified

similarities as a mechanism to distract the Court from the essential differences.

Lifescan first asserts that White and the Accused Product have a “pair of electrodes.” This is

profoundly misleading. In White, the “two electrodes” consist of one working electrode and one

reference electrode. Notably, any bioelectrical blood glucose monitoring system must include at

least two electrodes. Wang Decl., ¶ 4. By necessity, the current must flow from one electrode,

through the sample and to another electrode. Id. Bioelectrical sampling is impossible without at


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least two electrodes.15 Id. While White features the minimum required (one working and one

reference), the Accused Product features three electrodes: two working electrodes and one common

“reference” electrode. Dkt No. 35-5 (DeCinque Declaration, Ex. 5) at 4.

Similarly, whether White and the “equivalent” do or do not “perform safety checks” is a red

herring. As described in detail above, there are many ways to process the information received from

the electrodes. Neither White nor the Accused Product describe a “safety check.” Both describe

separate, entirely distinct mechanisms and processes for handling the multiple current readings to

achieve their stated objective. Lifescan’s simplification of the processes as a “safety check” ignores

all these critical process distinctions.

Lifescan also relies on irrelevant similarities between the Accused Products and the White.

Among other things, Lifescan notes that neither the Accused Product nor White “converts multiple

current measurements into multiple concentration measurements.” Motion at 24:3-5. However, this

approach merely focuses on things that neither the Accused Product nor White do not do – not what

they actually do. All of the following things do not “convert[] multiple current measurements into

multiple concentration measurements”: the Accused Products, the White reference, a cake donut.

Similarities regarding things not done do not suggest similar methods of operation.

Lifescan’s authority does not support the relief it requests. In each cited case, the prior art

was disclosed in an equivalent (which is not the case here) or the applicant explicitly abandoned the

equivalent during prosecution (also not the case here). See, e.g., Felix v. American Honda Motor

Co., 562 F.3d 1167, 1185 (Fed. Cir. 2009) (explicitly abandoned the equivalent); Amgen Inc. v.

Hoescht Marion Roussel, Inc., 457 F.3d 1293, 1315 (Fed. Cir. 2006) (explicit abandonment);

International Rectifier Corp. v. IXYS Corp., 515 F.3d 1353, 1360 (Fed. Cir. 2008) (same); Terlep v.

Brinkman Corp., 418 F.3d 1379, 1383-84 (Fed. Cir. 2005) (same); Cross Medical Products, Inc. v.

Medtronic Sofamor Danek, Inc., 480 F.3d 1335, 1343 (Fed. Cir. 2007) (same); O2 Micro Inter., Ltd.

v. Beyond Innovation Tech. Co., Ltd., 521 F.3d 1351, 1365 (Fed. Cir. 2008) (same); Chimie v. PPG

15 Smith testified that White only disclosed one working electrode and one reference electrode, which is the bare minimum required to perform a bioelectrical test. Grant Decl., Ex. A (Smith Depo.) at 32:6-11.


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Industries, Inc., 402 F.3d 1371, 1383 (Fed. Cir. 2005) (same); Schwarz Pharma, Inc. v. Paddock

Lab’s., Inc., 504 F.3d 1371, 1373 (Fed. Cir. 2007 (same). None of Lifescan’s authorities applying

prosecution history estoppel concern a situation, as is the case here, where the equivalent was not

found in the prior art and where the applicant’s expressed rationale for the amendment was

unrelated, or at most tangentially related, to the equivalent.

Discovery has demonstrated that the prior art did not disclose the operation of the Accused

Product. None of the “equivalents” disclosed during discovery are set forth in any of the prior art

references cited during prosecution. Lifescan’s belated attempt to redefine the equivalent in an

overly simplistic manner to gloss over important differences between blood glucose measurement

systems should be rejected.

Lifescan’s Motion depends squarely (and solely) upon the notion that the “equivalent” – as

first defined in Lifescan‘s Motion as a system that performs measures current and performs “safety

checks” – is disclosed in the prior art referenced during prosecution. Of course, this is a tortured and

unworkable definition of the “equivalent” – which is simply another name for the Accused Product

that is used in conjunction with performing a doctrine of equivalents analysis. As set forth above,

starting with any fair understanding of the Accused Products, as described by Lifescan’s own

counsel, or any definition of the “equivalent” proffered by the parties during discovery, summary

judgment in Lifescan’s favor is not warranted.

Critically, Lifescan’s Motion all but ignores the real issue now before the Court – i.e.,

whether there is a genuine issue of material fact regarding whether the rationale for the applicant’s

amendment was tangentially related to the equivalent/Accused Product. As set forth below, the

prosecution history establishes that rationale behind the amendments were, at most, only tangentially

related to the equivalent/Accused Product. In particular, none of the amendments or arguments even

remotely disclaimed the comparison of one current to another – either from one or more working

electrodes at the same time or different times. The Court should disregard any effort by Lifescan to

address this issue for the first time in its reply brief.


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B. The Rationale Behind The Amendments Was, At Most, Only Tangentially

Related To The Accused Products

Lifescan’s Motion is devoid of any argument or analysis regarding the rationale behind the

applicant’s amendment and the Accused Products. Lifescan’s Motion argues, in its entirety and

exclusively, that the operation of the Accused Products could be found in prior art cited during the

prosecution history and, therefore, the tangential relationship exception is not available. However,

as established above, the operation of the Accused Product was not disclosed in White or any other

prior art reference. Rather, the rationale behind the amendments made by the applicant was, at the

very most, only tangentially related to the Accused Products.

The Federal Circuit’s decision in Insituform controls here. Here, just as in Insituform, the

applicant sought narrowing amendments to avoid prior art. In Insituform, the narrowing amendment

surrendered ground that included the equivalent. Specifically, in that case, the claims were amended

to limit their scope to a single vacuum cup applied at multiple locations to avoid a reference (U.S.

Patent No. 4,182,262 (“Everson”)) that used a vacuum source fixed at a single, disadvantageous

location. The applicant distinguished the prior art thusly:

The principle reference relied on in the rejection of claims 1 to 6 is the patent to Everson (U.S. 4,182,262). Everson’s method is ineffective when dealing with long lengths of tube because that method requires an exceedingly large suction compressor. Applicant’s method solves the problem of impregnating long lengths of tubing by forcing a window in the tube’s impermeable skin, drawing the resin to the region of the window by a vacuum while squeezing the tube to force the resin to flow toward the evacuated region, sealing the window, and repeating the process at another window farther downstream. Thus by iterating and reiterating that process, the resin is drawn along to impregnate the entire length of tube.

Grant Declaration, Ex. B (Application Serial No. 231,695, 3/30/1982 Amendment).

The applicant in Insituform referred to the use of a single vacuum cup applied serially at

multiple locations to distinguish the invention from the prior art (Everson). However, the Federal

Circuit agreed that the narrowed claims could read on an accused device that used multiple vacuum

cups simultaneously. The Federal Circuit looked to Everson, the underlying prior art being avoided

(a vacuum cup placed at a single disadvantageous location), and held that the reason for the

narrowing amendment was only tangentially related to whether multiple vacuum cups were used:


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As the discussion above indicates, the narrowing amendment in this case was for the purpose of distinguishing the invention over Everson. Insituform made it

clear that the difference between its process and Everson was that its process did

not have the disadvantage of the Everson process of a large compressor at the

end of the liner. There is no indication in the prosecution history of any

relationship between the narrowing amendment and a multiple cup process,

which is the alleged equivalent in this case. Thus, we hold that plaintiffs have successfully rebutted the Festo presumption by establishing that the amendment narrowing the claimed invention from multiple cups to a single cup was tangential to accused Process 1, which used multiple cups attached at different points along the liner tube.

385 F.3d at 1370 (emphasis added).

The circumstances in the case now before the Court mirror those before the Federal Circuit in

Insituform. Here, the applicant amended their claims to avoid the prior art, including White. To

overcome the prior art, the applicant clarified that the invention was directed to a direct comparison

of measurements. Critically, the applicant did not state that the proposed claims were not directed to

current measurements nor did the applicant represent or assert that the proposed claims were directed

only to analytes. “There is no indication in the prosecution history of any relationship between the

narrowing amendment and a [current measurement], which is the alleged equivalent in this case.”

Id.

C. Argument Based Estoppel Does Not Apply

The record is devoid of any “clear and unmistakable” surrender of the Accused Products.

Deering Precision Instruments, 347 F.3d at 1326–27. At no point during the prosecution history did

the applicant unequivocally state that its claims would not cover a solution that compares current

readings. Schwing GmbH, 305 F.3d at 1327. As set forth above, the applicant engaged in the every-

day practice of describing the claimed invention during prosecution. The applicant did not repudiate

current readings. Further, the applicant did not identify any advantages of using analyte readings

versus current readings. In truth – there is little difference between the two measurements. There is

a constant relationship between current readings and analyte, much like Fahrenheit and Celsius. One

can easily be substituted for the other to perform calculations. When viewed in context, as is

required, the applicant distinguished the prior art on the grounds that it resorted to a complicated

mathematical ratio whereas the claimed invention was directed to a linear comparison. Read Corp.,


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970 F.2d 816. The statements made during prosecution fall well short of constituting a “clear and

unmistakable” surrender of the Accused Products.

Lifescan’s authority is inapplicable. Two of the three cases relied upon by Lifescan,

Luminara Worldwide, LLC v. Liowen Electronics Co. Ltd., 814 F.3d 1343, 1353 (Fed. Cir. 2016),

and Pacing Technologies, LLC v. Garmin Intern., Inc., 778 F.3d 1021, 1024 (Fed. Cir. 2015) discuss

the concept of a disclaimer. Argument-based prosecution history estoppel was not discussed in

either case. In the third case, Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336,

1349 (Fed. Cir. 2002), the Federal Circuit simply outlined the law and directed the district court to

apply the law to the facts. None of Lifescan’s authority suggests that argument-based estoppel

applies to these circumstances.

V. PROSECUTION HISTORY ESTOPPEL DOES NOT ESTOP PLAINTIFFS FROM

ASSERTING INFRINGEMENT OF THE ‘411 PATENT IN ACCORDANCE WITH

THE DOCTRINE OF EQUIVALENCE

The analysis regarding the ‘411 Patent is the same. Just as prosecution history estoppel does

not preclude Plaintiffs from asserting infringement of the ‘069 Patent under the doctrine of

equivalents, it does not preclude Plaintiffs from asserting infringement of the ‘411 Patent under the

doctrine of equivalents. None of the new references cited in the prosecution history of the ‘411

Patent disclosed the equivalent, the lone amendment made during prosecution did not surrender

ground occupied by the equivalent and none of the statements made by the applicant during

prosecution constituted a clear and unmistakable abandonment of the equivalent.

VI. CONCLUSION

For all of the foregoing reasons, Lifescan’s Motion for Summary Judgment should be denied.

Dated: August 28, 2017 FOX ROTHSCHILD LLP

/s/ Mark J. Connot Mark Connot (10010) 1980 Festival Plaza Drive, Suite 700 Las Vegas NV 89135 Attorneys for Plaintiffs Pharma Tech Solutions, Inc. and Decision IT Corp.


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