In Re Abbott Diabetes Care Inc. , 696 F.3d 1142 ( 2012 )

United States Court of Appeals
for the Federal Circuit
__________________________
IN RE ABBOTT DIABETES CARE INC.
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2011-1516, -1517
(Reexamination Nos. 90/007,903, 90/007,910)
__________________________
Appeal from the United States Patent and Trademark
Office, Board of Patent Appeals and Interferences.
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Decided: September 28, 2012
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GREGORY A. CASTANIAS, Jones Day, of Washington,
DC, argued for appellant. With him on the brief were
THOMAS E. FRIEBEL, of New York, New York; and ALYSON
G. BARKER, of Irvine, California. Of counsel on the brief
was LAURA A. THOMAS, Landau Gottfried & Berger LLP,
of San Francisco, California.
SYDNEY O. JOHNSON, JR. Associate Solicitor, United
States Patent and Trademark Office, of Alexandria,
Virginia argued for appellee. With him on the brief were
RAYMOND T. CHEN, Solicitor, and AMY J. NELSON, Associ-
ate Solicitor.
__________________________
Before LOURIE, PROST, and WALLACH, Circuit Judges.
IN RE ABBOTT DIABETES 2
PROST, Circuit Judge.
Abbott Diabetes Care, Inc. (“Abbott”) appeals from ex
parte reexamination proceedings in which the Board of
Patent Appeals and Interferences (“Board”) rejected
numerous claims of U.S. Patents Nos. 6,175,752 (“’752
patent”) and 6,565,509 (“’509 patent”). Ex parte Abbott
Diabetes Care Inc., No. 2010-006873, 2011 WL 180171(B.P.A.I. Jan. 18, 2011) (“’752 BPAI Op.”), reh’g denied,
2011 WL 1661489 (B.P.A.I. Apr. 29, 2011) (“’752 Reh’g
Denial”); Ex parte Abbott Diabetes Care Inc., No. 2010-
009711, 2011 WL 180180 (B.P.A.I. Jan. 18, 2011) (“’509
BPAI Op.”), reh’g denied, 2011 WL 1661491 (B.P.A.I. Apr.
29, 2011) (“’509 Reh’g Denial”). Because the Board’s
rejections were based on unreasonable claim construc-
tions and because the U.S. Patent and Trademark Office
(“PTO”) concedes that the examiner’s official notice rejec-
tions should be withdrawn, we vacate-in-part and re-
mand.
I. BACKGROUND
Abbott owns the ’752 patent and the ’509 patent.
Both patents share a common specification that describes
methods and devices “for the in vivo monitoring of an
analyte using an electrochemical sensor to provide infor-
mation to a patient about the level of the analyte” in the
bloodstream. ’752 patent col.1 ll.8-10; ’509 patent col.1
ll.11-14. Specifically, the specification describes methods
and devices for monitoring glucose levels for diabetics.
’752 patent col.1 ll.13-21; ’509 patent col.1 ll.17-25. The
specification notes that a variety of devices exist for
monitoring glucose levels in the blood stream, but some of
these devices include sensor guides that are “typically
bulky and do not allow for freedom of movement.” ’752
patent col.1 ll.51-54; ’509 patent col.1 ll.55-59. According
3 IN RE ABBOTT DIABETES
to the “Background of the Invention” portion of the speci-
fication, these prior art systems also feature external
wires and cables connecting the various components that
restrict the movements and daily life activities of the
user:
[T]he sensor guides or the sensors include cables
or wires for connecting the sensor to other equip-
ment to direct signals from the sensor to an ana-
lyzer. The size of the sensor guides and presence
of cables and wires hinders the convenient use of
these devices for everyday applications. There is
a need for a small, compact device that can oper-
ate the sensor and provide signals to an analyzer
without substantially restricting the movements
and activities of a patient.
’752 patent col.1 ll.55-63; ’509 patent col.1 ll.58-67.
The first claims of each patent are representative.
Claim 1 of the ’752 patent recites:
1. A sensor control unit comprising: a housing
adapted for placement on skin and adapted to re-
ceive a portion of an electrochemical sensor ex-
tending out of the skin having a plurality of
contact pads; a plurality of conductive contacts
disposed on the housing and configured for cou-
pling to the plurality of contact pads on the elec-
trochemical sensor; and an rf transmitter
disposed in the housing and coupled to the plural-
ity of conductive contacts for transmitting data
obtained using the electrochemical sensor.
(Emphasis added).
IN RE ABBOTT DIABETES 4
Claim 1 of the ’509 patent, which was amended dur-
ing reexamination, recites the following:
1. A sensor assembly to monitor an analyte, the
sensor assembly comprising: a flexible transcuta-
neous electrochemical sensor comprising non-
leachable, analyte-responsive enzyme, the sensor
having a distal end and a proximal end defining
the length of the sensor, such that a portion of the
sensor lies above the skin when transcutaneously
positioned; and a sensor control unit adapted for
placement on skin and adapted for receiving a
portion of the proximal end of the transcutaneous
electrochemical sensor, the sensor control unit
comprising a rf transmitter that is configured and
arranged to intermittently and repeatedly trans-
mit data related to analyte-dependent signals
generated by the electrochemical sensor, wherein
the portion of the sensor above the skin is main-
tained in a substantially fixed position relative to
the position of the sensor control unit when the
sensor control unit is placed on the skin and re-
ceives the proximal end of the sensor transcuta-
neously positioned.
(Emphasis added).
The specification describes the claimed “electrochemi-
cal sensor” as “a device configured to detect the presence
and/or measure the level of an analyte in a sample via
electrochemical oxidation and reduction reactions on the
sensor.” ’752 patent col.5 ll.47-50; ’509 patent col.5 ll.64-
67. As depicted in Figures 1 and 2 of Abbott’s patents, the
electrochemical sensor (42) uses conductive traces (52)
and contact pads (49) to transfer signals to a sensor
control unit (44).
5 IN RE ABBOTT DIABETES
IN RE ABBOTT DIABETES 6
On March 27, 2006, the PTO granted third-party re-
quests for ex parte reexamination of Abbott’s patents. 1
1 There are currently two lawsuits pending in the
United States District Court for the District of Delaware.
See Abbott Diabetes Care, Inc. v. DexCom, Inc., No. 05-590
(D. Del. filed Aug. 11, 2005); see also Abbott Diabetes
Care, Inc. v. DexCom, Inc., No. 06-514 (D. Del. filed Aug.
17, 2006). These actions have been consolidated and
stayed pending the outcome of several reexamination
proceedings, including the reexaminations for the ’752
and ’509 patents at issue in this appeal.
7 IN RE ABBOTT DIABETES
During reexamination, the examiner finally rejected all of
the claims subject to the reexamination as being indefi-
nite, anticipated, or obvious over several combinations of
prior art references. Particularly, the examiner relied on
European Patent Application 0 098 592 (“Shichiri I”), two
articles written by Shichiri et al. (“Shichiri II” and
“Shichiri III”), U.S. Patent No. 5,390,671 (“Lord II”),
combinations of other prior art references, and the exam-
iner’s official notice of certain features known in the prior
art.
In reviewing the examiner’s rejections, the Board first
had to determine the correct construction of “electro-
chemical sensor,” namely, whether “the transcutaneous
electrochemical sensor recited in the claims include[s]
wires and cables.” ’752 BPAI Op., 2011 WL 180171, at *4.
The Board reasoned that even though the specification
criticizes the external cables and wires of the prior art,
and none of the embodiments in Abbott’s patents include
external cables or wires connecting to the sensor control
unit, the absence of a more express limiting statement
meant that the “cables or wires” description of the prior
art sensors carried through to the claimed electrochemical
sensor as well. Ultimately, the Board concluded that
“when giving the term ‘electrochemical sensor’ the broad-
est reasonable interpretation in light of the [s]pecification,
the electrochemical senor includes wires and cables.” Id.
at *8; ’509 BPAI Op., 2011 WL 180180, at *7. The Board
also addressed the proper construction of the term “sub-
stantially fixed” recited in amended claim 1 of the ’509
patent and concluded that the term would “be understood
by the skilled worker to allow some movement of the
sensor relative to the position of the sensor control unit.”
’509 BPAI Op., 2011 WL 180180, at *8.
IN RE ABBOTT DIABETES 8
Having construed the claims, the Board went on to
consider whether the claims were properly rejected in
view of the prior art of record. The Board limited its
discussion of the prior art primarily to Shichiri I, “with
the understanding that our comments apply equally to
rejections based on Shichiri II and Fischell.” ’752 BPAI
Op., 2011 WL 180171, at *4; ’509 BPAI Op., 2011 WL
180180, at *4. Figures 1 and 3 of Shichiri I disclose a
watch-shaped transmitting assembly (2), with a blood
sugar detection unit (1) that includes an electrode means
(13) for measuring blood sugar. The signal from the
electrode means is fed through insulated lead wires (43)
and (44) through the catheter (45) to the watch-shaped
assembly. Additionally, the Board agreed with the exam-
iner’s conclusion that lead wires 43 and 44 are part of the
sensor.
Applying its construction of “electrochemical sensor”
as covering sensors with external cables or wires, the
9 IN RE ABBOTT DIABETES
Board held that Shichiri I anticipates claim 1 of the ’509
patent and also anticipates or renders obvious a large
portion of the other claims. ’509 BPAI Op., 2011 WL
180180, at *8-9. In addressing the construction of “sub-
stantially fixed” in amended claim 1 of the ’509 patent,
the Board reasoned that although Shichiri I discloses
wires (43) and (44) that are flexible and allow for some
movement, “they are still somewhat restrained in move-
ment, and are therefore ‘substantially fixed,’ by virtue of
being tethered to the watch assembly unit.” Id. at *8.
That is to say, the Board equated “somewhat restrained
in movement” to “allow[ing] some movement.”
With respect to the ’752 patent, the Board again ap-
plied its claim construction of “electrochemical sensor,”
and held that claim 1 and a large portion of the other
claims are unpatentable in light of Shichiri I in combina-
tion with Lord II. Although Shichiri I does not teach “at
least one contact pad” as required by claim 1 of the ’752
patent, the Board found that this feature was taught by
Lord II, which discloses a transcutaneous sensor having
sensor electrodes at one end and contact pads adapted for
connection to a monitor on the other end. Moreover, the
Board found that claim 1 “does not impose any particular
type of connection” between the electrochemical sensor’s
“contact pads” and the housing’s “conductive contacts,”
such as a direct connection, and therefore allows for a
cable or wire connection between the contact pads and the
conductive contacts. See ’752 BPAI Op., 2011 WL 180171,
at *8. Accordingly, the Board held that “Lord II provides
evidence that the conductive contacts in the sensor con-
trol unit of Shichiri I would have been configured for
coupling the equivalent contact pads of Shichiri I’s modi-
fied sensor.” Id. at *9. The Board also affirmed the
examiner’s use of official notice in combination with other
IN RE ABBOTT DIABETES 10
primary references to reject 157 newly added independent
and dependent claims.
Abbott filed requests for rehearing, arguing that,
when construing the term “electrochemical sensor,” the
Board improperly relied on the specification’s statement
that “sensors include cables or wires.” According to
Abbott, that statement simply criticizes the restrictive
prior art sensors—it does not describe the claimed elec-
trochemical sensor. The Board disagreed, instead holding
that the statement “provides insight as to how one of
ordinary skill in the art would interpret the term ‘sen-
sor.’” ’752 Reh’g Denial, 2011 WL 1661489, at *1; ’509
Reh’g Denial, 2011 WL 1661491, at *1. The Board also
found that nothing in Abbott’s patents explicitly disclaims
sensors that include external cables or wires. Addition-
ally, Abbott argued that the Board misapplied its own
construction of “substantially fixed” and also applied an
incorrect standard for official notice. But so too here, the
Board rejected Abbott’s arguments.
Abbott timely appealed, and we have jurisdiction pur-
suant to 28 U.S.C. § 1295(a)(4)(A).
II. DISCUSSION
We review the Board’s legal conclusions de novo and
its factual determinations for substantial evidence. In re
Am. Acad. Sci. Tech Ctr., 367 F.3d 1359, 1363 (Fed. Cir.
2004). Substantial evidence means “such relevant evi-
dence as a reasonable mind might accept as adequate to
support a conclusion.” Consol. Edison Co. v. NLRB, 305
U.S. 197, 229 (1938).
Claim construction is a legal question, reviewed de
novo. Am. Acad. Sci., 367 F.3d at 1363. In contrast to
11 IN RE ABBOTT DIABETES
district court proceedings involving an issued patent,
claims under examination before the PTO are given their
broadest reasonable interpretation consistent with the
specification. In re ICON Health & Fitness, Inc., 496 F.3d
1374, 1379 (Fed. Cir. 2007).
A. “Electrochemical Sensor”
The parties’ primary dispute centers on whether the
broadest reasonable construction of “electrochemical
sensor” includes external cables and wires connecting the
sensor to its control unit. Abbott argues that the Board
improperly relied on language in its patents that was
directed to the failings of the prior-art devices—failings
that the claimed invention attempts to overcome. Abbott
notes that all descriptions of the claimed electrochemical
sensor in the specification are devoid of any mention of
external cables or wires for connecting to the sensor
control unit. Abbott further contends that the plain
language of the claims—“contact pads” on the electro-
chemical sensor “coupl[ed]” to the “conductive contacts” of
the sensor control unit’s housing in the ’752 patent, or
having the transcutaneous electrochemical sensor “re-
ceiv[ed]” by the sensor control unit in the ’509 patent—
does not support an embodiment with external cables or
wires attached to the sensors.
The PTO argues that the specification acknowledges,
albeit when disparaging the prior art, that sensors can
include external cables or wires. See Retractable Techs.,
Inc. v. Becton, Dickinson & Co., 653 F.3d 1296, 1306 (Fed.
Cir. 2011) (“In general, statements about the difficulties
and failures in the prior art, without more, do not act to
disclaim claim scope.”). The PTO further contends that
neither the claims nor the specification explicitly require
the term “electrochemical sensor” to exclude sensors that
IN RE ABBOTT DIABETES 12
have external cables or wires. According to the PTO,
Abbott was required to make a “clear disavowal” or an
“express disclaimer” of claim scope. See Am. Acad. Sci.,
367 F.3d at 1363 (“[A] patentee ‘may demonstrate an
intent to deviate from the ordinary and accustomed
meaning of a claim term by including in the specification
expressions of manifest exclusion or restriction, repre-
senting a clear disavowal of claim scope.’”) (quoting Tele-
flex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325
(Fed. Cir. 2002)); In re Bigio, 381 F.3d 1320, 1325-26 (Fed.
Cir. 2004) (“Absent claim language carrying a narrow
meaning, the PTO should only limit the claim based on
the specification or prosecution history when those
sources expressly disclaim the broader definition.”).
The PTO also notes that the specification describes an
embodiment of the “sensor control unit 44” that “usually
includes no additional cables or wires to other electronic
components or other devices.” ’752 patent col.29 ll.65-67;
’509 patent col.29 ll.60-63. Relying on this statement, the
PTO argues that if the patentees had intended to disclaim
an electrochemical sensor with cables or wires, they
should have made a similar disclaimer with respect to the
electrochemical sensor—although the PTO acknowledges
that the term “usually” is less than precise. But in any
event, the PTO asserts that Abbott had “the opportunity
and responsibility to remove any ambiguity in claim term
meaning by amending” the claims during reexamination,
yet failed to do so. Bigio, 381 F.3d at 1324.
We agree with Abbott that the Board’s construction of
“electrochemical sensor” is unreasonable and inconsistent
with the language of the claims and the specification. As
a preliminary matter, the claims themselves suggest
connectivity without the inclusion of cables or wires: an
“electrochemical sensor” having “contact pads” that are
13 IN RE ABBOTT DIABETES
“coupl[ed]” to “conductive contacts” (in the ’752 patent), or
a “transcutaneous electrochemical sensor” that is “re-
ceiv[ed]” by the sensor control unit (in the ’509 patent).
That suggestion is only reinforced by the specification.
“Although the PTO emphasizes that it was required to
give all claims their broadest reasonable construction, . . .
this court has instructed that any such construction be
consistent with the specification, and that claim language
should be read in light of the specification as it would be
interpreted by one of ordinary skill in the art.” In re
Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2011)
(internal citation and quotation marks omitted). Indeed,
“the specification ‘is always highly relevant to the claim
construction analysis. Usually it is dispositive; it is the
single best guide to the meaning of a disputed term.’”
Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir.
2005) (en banc) (quoting Vitronics Corp. v. Conceptronic,
Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). Here, the
specification contains only disparaging remarks with
respect to the external cables and wires of the prior-art
sensors: “[t]he size of the sensor guides and presence of
cables and wires hinders the convenient use of these
devices for everyday applications.” ’752 patent col.1 ll.57-
59; ’509 patent col.1 ll.61-63. In fact, the primary purpose
of the invention was to provide “a small, compact device
that can operate the sensor and provide signals to an
analyzer without substantially restricting the movements
and activities of the patient.” ’752 patent col.1 ll.60-63;
’509 patent col.1 ll.64-67.
Even more to the point, every embodiment disclosed
in the specification shows an electrochemical sensor
without external cables or wires. Indeed, the only men-
tion of a sensor with external cables or wires in Abbott’s
patents is a single statement addressing the primary
deficiency of the prior art. It is true that the specification
IN RE ABBOTT DIABETES 14
does not contain an explicit statement disclaiming elec-
trochemical sensors with external cables or wires. But
this is not an instance where the specification would
necessarily have to disavow an embodiment that would
otherwise be covered by the plain language of the
claims—rather, claim terms like “coupl[ed]” and “re-
ceiv[ed]” are entirely consistent with and even support
the specification’s exclusive depiction of an electrochemi-
cal sensor without external cables or wires. We have held
that “[e]ven when guidance is not provided in explicit
definitional format, the specification may define claim
terms by implication such that the meaning may be found
in or ascertained by a reading of the patent documents.”
Iredeto Access, Inc. v. Echostar Satellite Corp., 383 F.3d
1295, 1300 (Fed. Cir. 2004) (internal quotation marks
omitted). Here, Abbott’s patents “repeatedly, consis-
tently, and exclusively” depict an electrochemical sensor
without external cables or wires while simultaneously
disparaging sensors with external cables or wires. Id. at
1303.
While Abbott’s patents define the electrochemical sen-
sor’s connectivity by implication, the PTO argues that our
case law still requires an explicit disclaimer of external
cables or wires. But the PTO’s reliance on cases like
Amercan Academy of Science and Retractable Technolo-
gies is misplaced. Although the patentee in Amercan
Academy of Science argued that it had disparaged and
therefore disclaimed the use of “multi-user computers
such as mainframes” in the background of the invention
section of its patent, that same background section and
the “specification as whole” actually supported configura-
tions that included multi-user computers. 367 F.3d at
1367. And in Retractable Technologies, the patentee’s
supposed disclaimer of “cutting” in the background of the
invention was undermined by an embodiment in the
15 IN RE ABBOTT DIABETES
specification that indicated that some forms of cutting fell
within the scope of the claimed invention. 653 F.3d at
1306. In the case before us, however, nothing suggests or
even hints that the claimed electrochemical sensor can
include external cables or wires. Instead, Abbott’s pat-
ents consistently show the opposite.
To be sure, the Board noted that Abbott’s patents ac-
knowledge that the “sensor control unit 44 usually in-
cludes no additional cables or wires.” The PTO argues
that a similar statement would be required to disclaim an
electrochemical sensor with external cables or wires. This
particular statement, however, refers to a specific em-
bodiment where the transmission of data from the sensor
control unit (44) to the receiver/display unit (46) “may
also be performed using methods other than rf transmis-
sion, including optical or wire transmission.” ’752 patent
col.52 ll.56-65; ’509 patent col.52 ll.56-65. Instead of
being an explicit disclaimer, the statement is actually an
explicit acknowledgment that at least some embodiments
of the sensor control unit can include external cables or
wires. Tellingly, the specification does not contain a
similar acknowledgment with respect to the electrochemi-
cal sensor.
We conclude, therefore, that under the broadest rea-
sonable construction, “electrochemical sensor” is properly
interpreted to mean a discrete electrochemical sensor
devoid of external connection cables or wires to connect to
a sensor control unit. Accordingly, we vacate the Board’s
decisions as to the patentability of Abbott’s independent
IN RE ABBOTT DIABETES 16
claims at issue 2 and remand for the Board to apply the
correct claim construction.
B. “Substantially Fixed”
The parties do not dispute that the correct construc-
tion of “substantially fixed” in the ’509 patent allows for
“some movement of the sensor relative to the position of
the sensor control unit.” Instead, the dispute between the
parties lies in whether “some movement” includes the
degree of movement in the Shichiri I system such that the
sensor need only be “somewhat restrained.” We conclude
that it does not.
The external wires of the Shichiri I sensor are only
“somewhat restrained” because they are tethered to a
watch-shaped assembly and therefore only restrained by
human arm or wrist movement. This degree of arm and
wrist movement is not only significantly greater than the
movement allowable under the Board’s original construc-
tion of “substantially fixed,” it is also greater than the
movement described in the specification. Indeed, the
embodiments disclosed in the ’509 patent all show the
above-skin portion of the electrochemical sensor main-
tained in a fixed position. Specifically, the specification
teaches a “support structure 82” that “hold[s], support[s],
and/or guide[s] the sensor 42 into the correct position.”
’509 patent col.34 ll.54-55. While the Board’s original
construction is reasonable in view of the specification, the
Board’s modified construction requiring only a “somewhat
restrained” sensor is not. On remand, the Board should
apply its original construction of “substantially fixed.”
2 These include claims 1, 32, 33, 39, 88, 89, 90, 244,
247, and 248 of the ’752 patent and claims 1, 11, 26, 229,
230, 231, and 233 of the ’509 patent.
17 IN RE ABBOTT DIABETES
C. Official Notice
During reexamination of the ’752 patent, the exam-
iner invoked the doctrine of official notice in combination
with other primary references to reject 157 newly added
independent and dependent claims. The Board affirmed,
and now nineteen of these official notice-rejection claims
are before this court on appeal. 3 The PTO, however, now
agrees with Abbott that the examiner’s official notice
rejection of these nineteen claims should be remanded
and withdrawn. Therefore, we vacate the Board’s rejec-
tion of these nineteen claims and remand to the Board for
appropriate further proceedings.
III. CONCLUSION
The Board’s construction of “electrochemical sensor”
and its modified construction of “substantially fixed” are
unreasonable and inconsistent with the specification. We
therefore vacate the Board’s decisions as to the pat-
entability of Abbott’s independent claims at issue and
remand for the Board to apply the correct claim construc-
tions. We also vacate the Board’s official notice rejection
of the nineteen claims before us and remand to the Board
for appropriate further proceedings.
VACATED-IN-PART AND REMANDED
3 These include claims 96, 98, 107, 125, 127, 139,
157, 159, 168, 186, 188, 196, 214, 216, 225, 244, 247-248,
and 251 of the ’752 patent.