LifeScan Scotland, Ltd. v. Shasta Technologies, LLC et al

Filing 443

CLAIM CONSTRUCTION ORDER re 415 and 417 Claim Construction Statements. Signed by Judge William H. Orrick on 11/10/2014. The parties shall attend a Case Management Conference on December 16, 2014 at 2:00 p.m. On or before December 9, 2014, the parties shall file a Joint Case Management Statement proposing either a joint case management schedule through trial or competing schedules. (jmdS, COURT STAFF) (Filed on 11/10/2014)

1
2
3
4

UNITED STATES DISTRICT COURT

5

NORTHERN DISTRICT OF CALIFORNIA

6
LIFESCAN SCOTLAND, LTD., et al.,

7

Case No. 11-cv-04494-WHO

Plaintiffs,
8
v.

CLAIM CONSTRUCTION ORDER

9
SHASTA TECHNOLOGIES, LLC, et al.,

10

Re: Dkt. Nos. 415, 417

Defendants.

United States District Court
Northern District of California

11
12
INTRODUCTION

13

Plaintiffs LifeScan Inc. and LifeScan Scotland, Ltd. (collectively, “LifeScan”) allege that

14
15

defendants Shasta Technologies, LLC, Conductive Technologies, Inc., Instacare Corp. and

16

Pharmatech Solutions, Inc. infringe U.S. Patents Numbers 5,708,247 (the “’247 patent”) and

17

6,241,862 (the “’862 patent”),1 which relate to blood glucose monitoring systems for use by

18
19
20
21
22
23
24
25
26
27
28

1

The amended complaint also asserts that defendants infringe U.S. Patent Number 7,250,105. See
Dkt. No. 170. That patent is not at issue in this claim construction proceeding. Per the parties’
stipulation, the causes of action regarding the ’105 patent were stayed in October 2013 pending
final decision by the Patent Trials and Appeals Board (“PTAB”) in the then-pending inter partes
review (“IPR”) of ’105 patent. Dkt. No. 372. The stay order stated that “[w]hen the PTAB issues
a final decision in the IPR concerning the ’105 Patent, the Court, on the request of any party, may
consider whether the stay provided in this paragraph should, or should not, continue during the
pendency of any appeals from that final decision.” Id. On August 7, 2014, after the present claim
construction briefing was complete, defendants filed a “Notice of Final IPR Decision [of the ’105
patent] and Automatic Lifting of Stay.” Dkt. No. 425. LifeScan promptly pointed out that the
stay order did not call for an “automatic lifting of stay.” Dkt. No. 429. LifeScan subsequently
stated why, in its opinion, the stay should remain in effect pending appeal from the IPR of the
’105 patent. Dkt. No. 437. Defendants have not responded to LifeScan’s argument that the stay
should remain in place during the appeal. If defendants contend that the stay should be lifted,
notwithstanding the appeal, they shall file an administrative motion seeking that relief within 20
days of this order.

1

people with diabetes. The parties have requested that the Court construe six disputed terms in the

2

asserted claims. Having fully considered the parties’ arguments and submissions, I construe the

3

disputed terms as set forth below.
BACKGROUND

4
5

The patents at issue relate to disposable test strips for glucose monitors. The ’247 patent is

6

entitled “Disposable Glucose Test Strips, and Methods and Compositions for Making Same” and

7

purports to provide “an improved disposable glucose test strip for use in a test meter of the type

8

which receives a disposable test strip and a sample of blood from a patient and performs an

9

electrochemical analysis of the amount of glucose in the sample.” ’247 patent at 2:39-44 (Dkt.
No. 409, Ex. B). The ’247 patent was filed on February 14, 1996 and issued on January 13, 1998.

11
United States District Court
Northern District of California

10

The ’862 patent is a continuation-in-part of the ‘247 patent and is entitled “Disposable Test

12

Strips with Integrated Reagent/Blood Separation Layer.” ’862 patent (Dkt. No. 409, Ex. C). The

13

’862 patent was filed on January 12, 1999 and issued on June 5, 2001.

14

The parties seek construction of three claim terms or phrases in the ’247 patent and three

15

claim terms or phrases in the ’862 patent. In addition, defendants contend that four of the terms

16

are indefinite. The claims at issue appear in the appendix at the end of this order.
LEGAL STANDARD

17
18

Claim construction is a matter of law for the court’s determination. Markman v. Westview

19

Instr., Inc., 517 U.S. 370, 372 (1996). In order to construe claim terms, “the trial court must

20

determine the meaning of any disputed words from the perspective of one of ordinary skill in the

21

pertinent art at the time of filing.” Chamberlain Grp., Inc. v. Lear Corp., 516 F.3d 1331, 1335

22

(Fed. Cir. 2008).

23

The words of a claim “are generally given their ordinary and customary meaning.”

24

Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (citations omitted). But the ordinary

25

and customary meaning of a claim term cannot be determined in a vacuum. Intrinsic evidence—

26

the claims, specification, and the prosecution history of the patent—“is the primary tool to supply

27

the context for interpretation of disputed claim terms.” V-Formation, Inc. v. Benetton Grp. SpA,

28

401 F.3d 1307, 1310 (Fed. Cir. 2005); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582
2

1

(Fed. Cir. 1996) (“It is well-settled that, in interpreting an asserted claim, the court should look

2

first to the intrinsic evidence of record, i.e., the patent itself, including the claims, the specification

3

and, if in evidence, the prosecution history.”).

4

The “specification necessarily informs the proper construction of the claims.” Phillips,
415 F.3d at 1316. It “is the single best guide to the meaning of a disputed term, and . . . acts as a

6

dictionary when it expressly defines terms used in the claims or when it defines terms by

7

implication.” Id. at 1321 (quotations omitted). However, “[t]hat claims are interpreted in light of

8

the specification does not mean that everything expressed in the specification must be read into all

9

the claims.” Raytheon Co. v. Roper Corp., 724 F.2d 951, 957 (Fed. Cir. 1983). “The claim, not

10

the specification, measures the invention.” Id. (citation omitted). For example, “merely because

11
United States District Court
Northern District of California

5

the specification only describes one embodiment is not a sufficient reason to limit the claims to

12

that embodiment.” Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1372 (Fed. Cir. 2003).

13

Nonetheless, “claims must be construed so as to be consistent with the specification.” Phillips,

14

415 F.3d at 1316.

15

The Federal Circuit has acknowledged “that there is sometimes a fine line between reading

16

a claim in light of the specification, and reading a limitation into the claim from the specification.”

17

Decisioning.com, Inc. v. Federated Dep’t Stores, Inc., 527 F.3d 1300, 1307 (Fed. Cir. 2008)

18

(internal citations omitted). The Federal Circuit instructs that “attempting to resolve that problem

19

in the context of the particular patent is likely to capture the scope of the actual invention more

20

accurately than either strictly limiting the scope of the claims to the embodiments disclosed in the

21

specification or divorcing the claim language from the specification, and, thus, that there can be no

22

magic formula or catechism for conducting claim construction.” Id. at 1307-08 (citing Phillips,

23

415 F.3d at 1323-24). Consequently, courts “must read the specification in light of its purposes in

24

order to determine whether the patentee is setting out specific examples of the invention to

25

accomplish those goals, or whether the patentee instead intends for the claims and the

26

embodiments in the specification to be strictly coextensive.” Decisioning.com, 527 F.3d at 1308

27

(internal citations omitted). The court’s focus is on “understanding how a person of ordinary skill

28

in the art would understand the claim terms.” Id.
3

“In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity

1
2

in a disputed claim term.” Vitronics, 90 F.3d at 1583. In those circumstances, it is improper to

3

rely on extrinsic evidence, such as dictionaries, treatises, and expert testimony. Id. If the intrinsic

4

evidence fails to resolve any ambiguity in the claim language, the court may rely on extrinsic

5

evidence. Id. While extrinsic evidence may guide the meaning of a claim term, such evidence is

6

less reliable than intrinsic evidence. See Phillips, 415 F.3d at 1318-19.
DISCUSSION

7
8

I.

9

DEFENDANTS’ INDEFINITENESS ARGUMENTS ARE MORE
APPROPRIATELY ADDRESSED AFTER THE CLOSE OF DISCOVERY
Defendants argue that several of the disputed claim terms are indefinite, rendering the

10
claims invalid. LifeScan responds that the asserted claims are not indefinite and, as an initial
11
United States District Court
Northern District of California

matter, the indefiniteness arguments are premature and should be addressed after the close of
12
discovery. For the reasons stated below, I agree with LifeScan that the indefiniteness arguments
13
are more appropriately addressed on summary judgment after the close of discovery.
14

“[A] patent is invalid for indefiniteness if its claims, read in light of the specification

15
delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those
16
17

skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 134
S. Ct. 2120, 2124 (2014) (citing 35 U.S.C. § 112, ¶ 2).2 To evaluate an indefiniteness claim, I

18
must (i) evaluate the claim from the perspective of someone skilled in the relevant art; (ii) read the
19

claim in light of the patent’s specification and prosecution history; and (iii) measure definiteness

20
from the viewpoint of a person skilled in the art at the time the patent was filed. Nautilus, 134 S.
21
Ct. at 2128 (citations omitted).
22
23

“[A] determination of claim indefiniteness is a legal conclusion that is drawn from the
court’s performance of its duty as the construer of patent claims.” In re Aoyama, 656 F.3d 1293,

24
1299 (Fed. Cir. 2011) (citation omitted). Accordingly, it may be appropriate to address
25
26
27
28

2

The second paragraph of Section 112 is now Section 112(b). Nautilus is based on the Patent Act
prior to the 2011 amendments to the Patent Act based on the filing date of the patent at issue. The
Supreme Court noted, however, that the 2011 “amendments modified §§ 112 and 282 in minor
respects not pertinent here.” Nautilus, 134 S. Ct. at 2125 n.1.
4

1

indefiniteness issues at the claim construction stage, rather than at summary judgment. For

2

example, in Prolifiq Software Inc. v. Veeva Sys. Inc., 2014 WL 3870016, at *8 (N.D. Cal. Aug. 6,

3

2014), Judge Illston noted that “[a]lthough expert testimony is generally helpful in determining

4

whether a claim is indefinite, expert testimony is not always required to make that determination.”

5

Judge Illston rejected an argument that it was premature to determine indefiniteness without expert

6

testimony, explaining that the term at issue in Prolifiq Software “allows the scope of the invention

7

to be determined by the unrestrained, subjective opinion of the person practicing the invention,

8

[and therefore] no one, including a person skilled in the art, can determine with reasonable clarity

9

the scope of the invention.” Id. (citation omitted).
In contrast, where extrinsic evidence of the perspective of someone skilled in the art is

11
United States District Court
Northern District of California

10

relevant to the indefiniteness inquiry, it is appropriate to defer the indefiniteness determination

12

until after the close of discovery. See, e.g., Intergraph Hardware Technologies Co. v. Toshiba

13

Corp., 508 F. Supp. 2d 752, 773 n.3 (N.D. Cal. 2007) (“The parties appear to agree on the

14

corresponding structure, though Toshiba argues that the structure is too indefinite. This

15

indefiniteness argument is inappropriate at the claim construction stage.”); Waddington N. Am.,

16

Inc. v. Sabert Corp., 2010 WL 4363137, at *3 (D.N.J. Oct. 27, 2010) (“It may be true that

17

determining the indefiniteness of claim language is a question of law ‘that is drawn from the

18

court’s performance of its duty as the construer of patent claims,’ which is the same duty that

19

gives rise to the Markman hearing. However, this does not outweigh the previous practical

20

considerations that militate against determining indefiniteness prior to the end of fact or expert

21

discovery.”) (citation omitted); cf Ateliers de la Haute-Garonne v. Broetje Automation-USA Inc.,

22

2014 WL 491534, at *2 (D. Del. Feb. 4, 2014) (noting that it is “appropriate for the Court to

23

consider extrinsic evidence relating to whether one of ordinary skill in the art would be capable of

24

understanding the claim containing the allegedly indefinite term”).

25

Defendants contend that the term “a filler having both hydrophilic and hydrophobic surface

26

regions,” which appears in claims 1 and 24 of the ’247 patent, is indefinite because “neither the

27

claim language nor the specification provide any guidance whatsoever as to the relative proportion

28

of hydrophobic surface regions to hydrophilic surface regions – i.e. the degree of hydrophobicity –
5

1

required to practice the patent.” Dkt. No. 417 at 9. Defendants also contend that the term “a filler

2

. . . that forms a network upon drying,” which appears in the same claims, is indefinite because it

3

is defined only by its function, i.e., forming a network upon drying.
I cannot conclude on the record before me that the claims at issue fail to inform someone

4
5

skilled in the art about the scope of the invention with reasonable certainty. For example, the

6

specification of the ’247 patent provides guidance regarding the required levels of hydrophobicity:

7

it identifies substances that are too hydrophobic (C18-modified silica) and others that are the

8

correct level of hydrophobic (Cab-O-Sil TS610). See ’247 patent at 4:12-26. Expert testimony

9

will help inform whether this or other information in the patent is insufficient for someone skilled

10

in the art to determine the scope of the invention with reasonable certainty.3
Likewise, I cannot conclude on the record before me that the term, “a filler . . . that forms a

United States District Court
Northern District of California

11
12

network upon drying,” recites a function and renders the claims indefinite.4 See, e.g., Lighting

13

World, Inc. v. Birchwood Lighting, Inc., 382 F.3d 1354, 1359-60 (Fed. Cir. 2004) (in order for a

14

claim to be defined by structure rather than function, “it is sufficient if the claim term is used in

15

common parlance or by persons of skill in the pertinent art to designate structure, even if the term

16

covers a broad class of structures and even if the term identifies the structures by their function.”).

17

Defendants indefiniteness objections to the terms, “a[n] . . . integrated reagent/blood

18

separation layer” and “matrix effective to exclude blood cells . . . while permitting access . . . by

19

soluble electroactive species,” which appear in claims 1, 2, 11, 22, and 23 of the ’862 patent, are

20

premature for the same reasons. Expert discovery will inform whether these claims would be

21

indefinite to a person skilled in the art. Defendants may renew their indefiniteness arguments after

22
23
24
25
26
27
28

3

Defendants reference the testimony of Dr. Wilson in support of their indefiniteness argument.
But the referenced testimony relates to declarations submitted by Dr. Wilson in connection with
reexamination of the ’247 patent in which Dr. Wilson addressed defendants’ assertion that the
patent was obvious in view of certain prior art references. I have not yet set deadlines for expert
reports or expert discovery in this case.
4

LifeScan asserts that this term is not functional because it “simply tells the reader when the
network is formed, i.e., the network is formed when the filler dries.” Dkt. No. 421 at 9 (emphasis
in original).
6

1

the close of discovery in a motion for summary judgment.5

2

II. CONSTRUCTIONS OF DISPUTED TERMS

3

A. A filler having both hydrophilic and hydrophobic surface regions (’247 patent,
claims 1, 24)

4

LifeScan’s proposed
construction

Defendants’ proposed
construction

Court’s construction

additive having some surface
regions that lack an affinity for
water and some surface
regions that have an affinity
for water

Objection: Compound defined
by its characteristics only is
indefinite.

additive having some surface
regions that lack an affinity for
water and some surface
regions that have an affinity
for water

5
6
7
8
9

1. Modified or treated silica.

10

2. A filler that has a portion of
it surface region that easily
dissolves when hydrated and
other portions of its surface
that does not such that the
network6 remain intact and
does not dissolve upon
rewetting by the blood sample
and renders the test strip
substantially insensitive to the
hematocrit of the patient.7

11
United States District Court
Northern District of California

Alternative Constructions:

12
13
14
15
16
17

LifeScan’s proposed construction substitutes the term “additive” for the term “filler” and

18

restates the term “hydrophilic and hydrophobic surface regions” as “some surface regions that lack

19

an affinity for water and some surface regions that have an affinity for water.” Defendants do not

20

contend that LifeScan’s proposed definitions are inaccurate. Rather, defendants argue that the

21
22
23
24
25
26

5

The indefiniteness issue may be renewed in a motion for summary judgment. Any disputed
questions of fact will not preclude summary judgment of indefiniteness. Rather, any disputed
facts will be resolved by me, along with the ultimate question of indefiniteness. See, e.g.,
Thought, Inc. v. Oracle Corp., 12-cv-05601-WHO, 2014 WL 5408179, at *8 (N.D. Cal. Oct. 22,
2014) (“because indefiniteness is a question of law for the court to determine, I must resolve any
disputed issue of material fact based on the evidence before me”).
6

27
28

Terms subject to construction are italicized.

7

Defendants did not support their second proposed construction in their briefing or at the claim
construction hearing. I likewise do not address the second proposed construction.
7

1

patentee, pursuant to the doctrine of prosecution history disclaimer, limited the filler at issue to

2

silica, the preferred embodiment disclosed in the specification.

3

Under the doctrine of prosecution history disclaimer, “when the patentee unequivocally

4

and unambiguously disavows a certain meaning to obtain a patent . . . the meaning of the claim [is

5

narrowed] consistent with the scope of the claim surrendered.” Biogen Idec, Inc. v.

6

GlaxoSmithKline LLC, 713 F.3d 1090, 1094 (Fed. Cir. 2013). Relatedly, “when the specification

7

uses a single embodiment to enable the claims, courts should not limit the broader claim language

8

to that embodiment unless the patentee has demonstrated a clear intention to limit the claim scope

9

using ‘words or expressions of manifest execution or restriction.’” Trading Technologies Int’l,
Inc. v. eSpeed, Inc., 595 F.3d 1340, 1352 (Fed. Cir. 2010) (internal punctuation and citation

11
United States District Court
Northern District of California

10

omitted).

12

Defendants argue that the patentee disavowed any construction of “filler” other than silica

13

when, during the prosecution history, it agreed to an examiner’s amendment to Claim 17 which

14

inserted the term “silica” before “filler” in order to overcome rejection of that claim, i.e., a “silica

15

filler having both hydrophilic and hydrophobic surface regions.” The examiner’s statement of

16

reasons for allowance noted that “[t]he composition of claim 17 was changed by amendment to

17

correct the indefiniteness of the claim with respect to the filler which recited a physical property

18

having no specific composition.” Dkt. No. 416-5 at 11. Claim 17 is not asserted here, but

19

defendants argue that the disclaimer of Claim 17 applies to claim 1 because the claims both

20

contain the term “filler having hydrophobic and hydrophilic surface regions.”

21

I am not convinced that the patentee of the ’247 patent unequivocally and unambiguously

22

disavowed a meaning of filler other than silica in claims 1 and 24, the claims at issue here.

23

Notably, unlike claim 17, claims 1 and 24 were issued without addition of the term “silica.” The

24

Federal Circuit instructs that “when a patent claim does not contain a certain limitation and

25

another claim does, that limitation cannot be read into the former claims.” Amgen Inc. v. Hoechst

26

Marion Roussel, Inc., 314 F.3d 1313, 1326 (Fed. Cir. 2003) (citation omitted).

27
28

Moreover, the examiner initially rejected claims 1 through 35 (including claims 1 and 24)
on the grounds that the only example of enabling filler disclosed in the patent was silica. Dkt. No.
8

1

416-4 at 33. But the examiner withdrew the objection after the patentee responded that it had no

2

obligation to provide enabling examples. The examiner’s statement of reasons for allowance

3

states that “[t]he prior art of record fails to teach the key to the applicants instant invention which

4

is the inclusion of a filler having hydrophobic and hydrophilic surface regions.” Dkt. No. 416-5 at

5

11. This prosecution history indicates that the examiner was directly focused on the limitations

6

disclosing filler and suggests that the examiner determined that Claim 17 was indefinite without

7

disclosing silica, but that claims 1 and 24 did not need to disclose silica in order to avoid

8

indefiniteness. Indeed, claims 3 and 26, which are not asserted in this case, recite the test strip of

9

claim 2 and the method of claim 25, respectively, but add the limitation: “wherein the filler is
silica.” 8 See ’247 patent at 7:46, 8:52. Limiting the filler disclosed in claims 2 and 25 to silica

11
United States District Court
Northern District of California

10

would render claims 3 and 26 superfluous. In light of the attention the examiner and the patentee

12

paid to all the limitations involving filler, and that the examiner required that silica be disclosed in

13

claim 17 but not claims 1 and 24, I cannot conclude that the patentee unequivocally and

14

unambiguously disavowed a meaning of filler broader than silica in claims 1 and 24.9
LifeScan’s proposed construction employs clear, easily-understood language and its

15
16

accuracy has not been challenged by defendants. I accordingly adopt LifeScan’s proposed

17

construction: “additive having some surface regions that lack an affinity for water and some

18

surface regions that have an affinity for water.”

19
20
21
22
23
24
25
26
27
28

8

Claims 2 and 25 are dependent on claims 1 and 24, respectively, both of which contain the
disputed term at issue here: “a filler having both hydrophilic and hydrophobic surface regions.”
9

The record before me does not state why the examiner determined that claim 17 was indefinite
without disclosing silica, but claims 1 and 24 were not. I note, however, that claim 17 is directed
to an “aqueous composition,” whereas claims 1 and 24 are directed to a test strip and a method for
making the test strip.
9

1
2

B. Network (’247 patent, claims 1, 24)
LifeScan’s proposed
construction

Defendants’ proposed
construction

Court’s construction

3
4
5
6

ordinary meaning

A netting, mesh, lattice or
honeycomb structure having
or
physically interconnected
structure that provides a barrier strands that form porous
to the passage of red blood
pathways.
cells

structure

7
8
9
10

United States District Court
Northern District of California

11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

LifeScan proposes that “network” be given its ordinary meaning (not construed) or
construed as “structure that provides a barrier to the passage of red blood cells.” LifeScan’s
proposed construction includes language which relates to the purpose of the “network,” i.e.,
“provides a barrier to the passage of red blood cells.” The purpose of the network is addressed
below in the construction of “a filler . . . that forms a network upon drying.” There is no reason to
also construe the term “network,” standing alone, in a manner which incorporates its purpose.
Stripped of that extraneous language, LifeScan’s proposed construction is that the term “structure”
be substituted for the claim term “network.”
Defendants also employ the term “structure” in their proposed construction: “a netting,
mesh, lattice or honeycomb structure having physically interconnected strands that form porous
pathways.” However, defendants’ proposed construction includes descriptions of the structure
imported from the specification. For example, the specification states that “the dual nature of the
material causes it to form layers of two-dimensional networks which take form as a kind of
honeycomb.” ’247 patent at 4:37-39. Defendants provide no compelling reason to import those
examples from the specification into the claim. See e.g., In re Omeprazole Patent Litig., 483 F.3d
1364, 1372 (Fed. Cir. 2007) (“Absent some clear intent to the contrary, this court does not import
examples from the specification into the claims.”).
Consistent with the parties’ constructions, but excluding qualifying language proposed by
the parties which is not warranted, I construe the claim term “network” as “structure.”

27
28
10

1
2

C. A filler . . . that forms a network upon drying (’247 patent, claims 1, 24)
LifeScan’s proposed
construction

Defendants’ proposed
construction

Court’s construction

3
4
5
6

Additive that forms a structure Objection: Compound defined
that provides a barrier to the
by its functionality only is
passage of red blood cells upon indefinite.
drying
Alternative Constructions:
1. Sol‐gel silica‐‐ silica that
forms a network upon drying
through a sol‐gel process that
allows the glucose from a
blood sample to pass into the
layer while excluding the red
blood cells of from the layer to
provide a glucose reading that
is essentially independent to
variability in red blood cell
counts of patients.

7
8
9
10

United States District Court
Northern District of California

11
12

2. A filler that forms a network
through a sol‐gel process that
allows the glucose from a
blood sample to pass into the
layer while excluding the red
blood cells of from the layer to
provide a glucose reading that
is essentially independent to
variability in red blood cell
counts of patients.

13
14
15
16
17
18
19
20
21
22
23
24
25
26
27

Additive that forms a structure
upon drying that excludes red
blood cells while allowing
glucose to pass through

LifeScan proposes that “a filler . . . that forms a network upon drying” be construed as
“additive that forms a structure that provides a barrier to the passage of red blood cells upon
drying.” A portion of this construction — “additive that forms a structure . . . upon drying” — is
consistent with the term’s plain language and the constructions of the terms “filler . . .” and
“network” discussed above.
However, the remaining proposed language — “that provides a barrier to the passage of
red blood cells” — is not inherent in the disputed claim language itself, but describes the function
or objective of the network. Defendants likewise propose language which describes the function
or objective of the network, i.e., “allows the glucose from a blood sample to pass into the layer

28
11

1

while excluding the red blood cells.” In its reply brief, LifeScan states that “[i]t is acceptable to

2

LifeScan, however, for the Court to accept defendants’ assertion that a ‘network’ is a filtering

3

mechanism formed from aggregated or interconnected particles that excludes red blood cells while

4

permitting the through passage of glucose.” Dkt. No. 421 at 12.

5

As the parties appear to agree that the term should incorporate a purpose of this limitation,

6

I will construe the term consistent with its plain language, the constructions addressed above, and

7

the portions of its purpose to which the parties agree. Accordingly, I construe “a filler . . . that

8

forms a network upon drying” as an “additive that forms a structure upon drying that excludes red

9

blood cells while allowing glucose to pass through.”

10

United States District Court
Northern District of California

11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
12

D. A[n] . . . integrated reagent/blood separation layer (’862 patent, claims 1, 2, 11, 22,
23)

1
2

LifeScan’s proposed
construction

Defendants’ proposed
construction

A single layer that contains
reagents, is permeable to the
analyte, and provides a barrier
to the passage of red blood
cells

Objection: Compound defined
by its functionality only is
indefinite.

3
4
5
6

8
9
10

United States District Court
Northern District of California

11
12

2. A layer created using a sol‐
gel process that includes a
reagent that allows glucose to
pass into the layer while
excluding the red blood cells
of the same blood sample to
provide a glucose reading that
is essentially independent to
variability in red blood cell
counts of patients.

13
14
15
16
17
18
19

21
22

A single layer that contains
reagents, is permeable to the
analyte, and excludes red
blood cells

1. Silica combined with
reagents through a sol‐gel
process that allows the glucose
to pass into the layer while
excluding the red blood cells
of the same blood sample to
provide a glucose reading that
is essentially independent to
variability in red blood cell
counts of patients.

7

20

Alternative Constructions:

Court’s construction

The ’862 patent is a continuation-in-part of the ’247 patent.10 It is directed at providing
glucose readings which are not affected by the level of red blood cells in the blood sample.11 ’862
patent at 2:49-53. Prior methods of preventing red blood cells from interfering with the readings
while allowing glucose to be measured consisted of adding a layer to the test strip which filtered

23
24
25
26
27
28

10

A continuation-in-part is an application filed during the lifetime of an earlier nonprovisional
application, repeating some substantial portion or all of the earlier nonprovisional application and
adding matter not disclosed in the said earlier nonprovisional application. See Manual of Patent
Examining Procedure § 201.08.
11

In prior methods of glucose testing, blood samples with high levels of red blood cells result in
readings that are lower than the true value, while blood samples with low levels of red blood cells
result in readings that are higher than the true value. See ’862 patent at 2:23-33.
13

1

out red blood cells, in addition to the layer which contains the substances used for the

2

electrochemical detection of the glucose (the reagent layer). ’862 patent at 2:33-38. Using two

3

separate layers added extra steps to the manufacturing process, which led to increased costs and

4

decreased precision. ’862 patent at 2:39-42. In order to limit interference from red blood cells

5

without the added manufacturing costs and degraded performance, the inventors of the ’862 patent

6

created an “integrated reagent/blood separation layer” which, in one layer, contains the reagents

7

for electrochemical detection of glucose and also excludes red blood cells while allowing glucose

8

to pass through. ’862 patent at 3:8-13.
LifeScan proposes that “an . . . integrated reagent/blood separation layer” be construed as

9

“a single layer that contains reagents, is permeable to the analyte, and provides a barrier to the

11
United States District Court
Northern District of California

10

passage of red blood cells.”12 LifeScan’s proposal appears consistent with the plain language of

12

the disputed terms and the object of the integrated reagent/blood separation layer, as discussed

13

above.
In contrast, defendants seek a construction which states that the integrated reagent/blood

14
15

separation layer is silica and/or created through a “sol‐gel process.” For the reasons stated above,

16

limiting the claim to silica is not warranted. Likewise, defendants offer no compelling

17

justification for reading a “sol-gel process”, which is not mentioned anywhere in the patent, into

18

the claim language.
Defendants also argue that LifeScan’s proposal that the integrated reagent/blood separation

19
20

layer be construed as providing “a barrier to the passage of red blood cells” is incorrect because

21

the invention needs to exclude red blood cells, not merely act as a barrier, in order to achieve

22

glucose readings which are not affected by the level of red blood cells in the sample.13 I agree.

23

Indeed, the specification states that the integrated reagent/blood separation layer is “effective to

24

exclude blood cells.” ’862 patent 3:8-13 (emphasis added); see also id. at 7:6-9 (“Reactants such

25
26
27
28

12

An analyte is “a chemical substance that is the subject of chemical analysis.” See
http://www.merriam-webster.com/dictionary/analyte.
13

The level of red blood cells in blood is known as hematocrit. See http://www.merriamwebster.com/dictionary/hematocrit.
14

1

as enzyme, mediator and glucose move freely within this zone, but interfering species such as red

2

blood cells containing oxygenated hemoglobin are excluded.”).
For the reasons stated above, I construe “an . . . integrated reagent/blood separation layer”

3
4

as “a single layer that contains reagents, is permeable to the analyte, and excludes red blood cells.”

5

E. Matrix (’862 patent, claims 1, 22)

6

LifeScan’s proposed
construction

7
8

ordinary meaning

9

or

10

United States District Court
Northern District of California

11
12

Substance or structure in
which something is contained

Defendants’ proposed
construction
A network that affects the
sample being tested; in this
case, a network that allows the
analyte being tested in the
blood sample to pass while
excluding from the layer other
interfering materials in the
sample

Court’s construction
Substance or structure in
which something is contained

13

LifeScan proposes that “matrix” be given its ordinary meaning (not construed) or

14

construed as “substance or structure in which something is contained.” “Matrix” is not defined in

15

the patent, but LifeScan’s proposed construction is consistent with the ordinary meaning of

16

“matrix.” For example, the American Heritage Dictionary defines matrix as “a situation or

17

surrounding substance within which something else originates, develops, or is contained.” See

18
19
20
21

https://ahdictionary.com/word/search.html?q=matrix.
In contrast, defendants propose a construction which includes unwarranted limitations: “a
network that affects the sample being tested; in this case, a network that allows the analyte being
tested in the blood sample to pass while excluding from the layer other interfering materials in the

22

sample.” Much of defendants’ proposed construction relates to the integrated reagent/blood

23

separation layer’s role in enabling the glucose to be tested without interference from red blood

24

cells in the blood sample. But the surrounding claim language already states that the “matrix”

25

excludes blood cells while allowing access to glucose. See ’862 patent at 11:47-50, 12:67-13:3

26

(“matrix effective to exclude blood cells from the surface of the first conductive element while

27

permitting access to the first conductive element by soluble electroactive species”). Reading this

28
15

1

function into the term matrix itself would render the surrounding language superfluous.
Consistent with its ordinary meaning, I construe “matrix” as “substance or structure in

2
3

which something is contained.”

4

F. Matrix effective to exclude blood cells . . . while permitting access . . . by soluble
electroactive species (’862 patent, claims 1, 22)

5

LifeScan’s proposed
construction

6

Defendants’ proposed
construction

Court’s construction

Objection: Compound defined
by its functionality only is
indefinite.

Matrix that excludes red blood
cells while permitting
access…by soluble
electroactive species.

7
8
9
10

Matrix that provides a barrier
to the passage of blood cells
while permitting access to the
first conductive element by
soluble electroactive species.

1. A silica matrix whose pore
size has been controlled to
allow glucose to pass while
excluding the red blood cells in
the sample sufficiently to
render the strip substantially
insensitive to variability in red
blood cell counts of patients.

United States District Court
Northern District of California

11
12
13
14
15

2. A matrix whose pore size
has been controlled to allow
glucose to pass while
excluding the red blood cells in
the sample sufficiently to rend
[sic] the strip substantially
insensitive to variability in red
blood cell counts of patients.

16
17
18
19
20
21

Alternative Constructions:

LifeScan proposes that “matrix effective to exclude blood cells . . . while permitting access
. . . by soluble electroactive species” be construed as “matrix14 that provides a barrier to the

22
passage of blood cells while permitting access to the first conductive element by soluble
23
24
25

electroactive species.” Defendants propose constructions which state that the matrix’s “pore size
has been controlled to allow glucose to pass while excluding the red blood cells in the sample
sufficiently to render the strip substantially insensitive to variability in red blood cell counts of

26
27
28

14

As noted above, I construe “matrix” as “substance or structure in which something is
contained.”
16

1

patients.”15
Reading in the pore size limitation is not warranted. The single sentence from the

2
3

prosecution history which LifeScan references (Dkt. No. 417 at 25) does not show that the

4

patentee “unequivocally and unambiguously” disclaimed a meaning of matrix other than one

5

which relies on pore size to exclude blood cells. Biogen Idec, 713 F.3d at 1094.
Consistent with the reasoning and constructions above, I construe “matrix effective to

6
7

exclude blood cells . . . while permitting access . . . by soluble electroactive species” as “matrix

8

that excludes red blood cells while permitting access … by soluble electroactive species.”16

9
10

United States District Court
Northern District of California

11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28

15

Defendants offer two alternative constructions. The first proposed construction limits the
matrix at issue to a “silica matrix”; the second proposed construction does not. In addition, in
their claim construction brief, defendants’ second proposed construction construes the matrix as
rendering the test strip “substantially insensitive to variability in red blood cell counts of patients
[sic] hematocrit of patients [sic].” This construction (and apparent typographical error) was not
disclosed in the parties’ joint claim chart. Dkt. No. 409 at 22. Rather, there both of defendants’
proposed alternative constructions construed the matrix as rendering the test strip “substantially
insensitive to variability in red blood cell counts of patients. Id. In any event, I see no material
difference between rendering the test strip insensitive to variability in red blood cell counts of
patients, and rendering the test strip insensitive to variability in the hematocrit of patients, given
that hematocrit refers to the level of red blood cells in blood. See supra n.13.
16

LifeScan seeks a construction which includes the terms “to the first conductive element” in
place of the ellipsis. That language appears verbatim in the claims at issue. But the portion of the
claims which the parties have asked me to construe, “matrix effective to exclude blood cells . . .
while permitting access . . . by soluble electroactive species,” specifically excludes that language.
Accordingly, while the claim, as construed, reads “matrix that excludes red blood cells while
permitting access [to the first conductive element] by soluble electroactive species,” the bracketed
language is not itself part of the construction; it is the original language of the claim which
corresponds to the ellipses in the construction.
17

CONCLUSION

1

I construe the disputed terms as follows:

2
3

Term
4
5

A filler having both hydrophilic and
hydrophobic surface regions

Additive having some surface regions that lack
an affinity for water and some surface regions
that have an affinity for water

Network

Structure

A filler . . . that forms a network upon drying

Additive that forms a structure upon drying that
excludes red blood cells while allowing glucose
to pass through

A[n] . . . integrated reagent/blood separation
layer

A single layer that contains reagents, is
permeable to the analyte, and excludes red
blood cells

Matrix

Substance or structure in which something is
contained

Matrix effective to exclude blood cells . . .
while permitting access . . . by soluble
electroactive species

Matrix that excludes red blood cells while
permitting access…by soluble electroactive
species

6
7
8
9
10

United States District Court
Northern District of California

11
12
13
14
15

Construction

16
17
18
19
20
21
22
23

The parties shall attend a Case Management Conference on December 16, 2014 at 2:00
p.m. On or before December 9, 2014, the parties shall file a Joint Case Management Statement
proposing either a joint case management schedule through trial or competing schedules.
IT IS SO ORDERED.
Dated: November 10, 2014
______________________________________
WILLIAM H. ORRICK
United States District Judge

24
25
26
27
28
18

APPENDIX: CLAIMS AT ISSUE

1
2
3
4
5
6
7
8
9
10

United States District Court
Northern District of California

11
12
13

The disputed terms in the ’247 patent appear in claims 1 and 24. Claims 1 and 24, with the
disputed terms italicized, recite:
Claim 1. A disposable glucose test strip for use in a test meter of the type which
receives a disposable test strip and a sample of blood from a patient and performs
an electrochemical analysis of the amount of glucose in the sample, comprising:
(a) a substrate;
(b) a reference electrode;
(c) a working electrode, said working electrode comprising a
conductive base layer disposed on the substrate and a first
working coating disposed over the conductive base layer, said
first working coating comprising a filler having both
hydrophobic and hydrophilic surface regions such that it forms a
network upon drying, an enzyme effective to oxidize glucose,
and a mediator effective to transfer electrons from the enzyme to
the conductive base layer; and
(d) means for making an electrical connection between the
reference and working electrode and a glucose test meter.

14

Claim 24. A method for making a disposable test strip for the electrochemical
detection of glucose, comprising the steps of:

15

(a) applying working and reference electrode tracks to a substrate;

16

(b) applying a conductive base layer in contact with the working
electrode track; and

17
18
19
20
21
22
23
24
25
26
27
28

(c) applying a working layer over the conductive base layer, wherein
the working layer comprising a filler having both hydrophobic and
hydrophilic surface regions such that it forms a network upon drying, an
enzyme effective to oxidize glucose, and a mediator effective to transfer
electrons from the enzyme to the conductive base layer.
The disputed terms in the ’862 patent appear in claims 1, 2, 11, 22, 23. Those claims, with
the disputed terms italicized, recite:
Claim 1. A disposable test strip for use in a test meter which receives a disposable
test strip and a sample of blood and performs an electrochemical analysis of the
amount of a blood analyte in the sample, comprising:
(a) a substrate;
(b) a first conductive element disposed on the substrate;
(c) a second conductive element disposed on the substrate in sufficient
proximity to the first conductive element to allow the completion of an
electrical circuit between the first and second conductive elements when a
sample of blood is placed on the test strip;
19

1
2
3
4
5
6
7
8
9
10

United States District Court
Northern District of California

11
12
13

(d) a non-conductive integrated reagent/blood separation layer disposed over
the first conductive element, said integrated reagent/blood separation layer
comprising reagents for the electrochemical detection of the analyte
dispersed in a non-conductive matrix effective to exclude blood cells from
the surface of the first conductive element while permitting access to the
first conductive element
(e) by soluble electroactive species; and
(f) contacts for making an electrical connection between the first and second
conductive elements and the test meter.
Claim 2. The test strip of claim 1, wherein the integrated reagent/blood separation
layer comprises an enzyme for oxidation of glucose and a redox mediator effective
to transfer electrons from the enzyme to the first conductive element.
Claim 11. The test strip of claim 1, further comprising an insulation layer disposed
over at least the first conductive elements, said insulation layer having a first
aperture therein aligned with the first conductive element, wherein the nonconductive integrated reagent/blood separation layer contacts the first conductive
element through the aperture in the insulation layer.
Claim 22. A method for forming a disposable test strip for use in a test meter which
receives a disposable test strip and a sample of blood and performs an
electrochemical analysis of the amount of a blood analyte in the sample,
comprising:

14

(a) forming first and second conductive elements on a substrate;

15

(b) forming a layer of insulation covering the first conductive element, said
layer of insulation having a first aperture therein aligned with a portion of
the first conductive element in a sample application region; and

16
17
18
19
20
21
22
23

(c) forming a integrated reagent/blood separation layer layer [sic] disposed on
the insulation layer and making contact with the first conductive element
through the first aperture in the insulation layer, said integrated
reagent/blood separation layer comprising reagents for the electrochemical
detection of glucose dispersed in a non-conductive matrix effective to
exclude blood cells from the surface of the first conductive element while
permitting access to the first conductive species by soluble electroactive
species, whereby the first conductive element is isolated from direct contact
with a sample placed on the test strip.
Claim 23. The method of claim 22, wherein the reagent layer is a non-conductive
integrated reagent/blood separation layer.

24
25
26
27
28
20