Ex Parte 6329161 et al

Patent Trial and Appeal Board

Feb 19, 2015

90009620 (P.T.A.B. Feb. 19, 2015)

UNITED STATES PATENT AND TRADEMARKOFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
90/009,620 10/27/2009 6329161 TS-02-163C07-RE4 8417
30349 7590 02/19/2015
JACKSON & CO., LLP
6114 LA SALLE AVENUE
#507
OAKLAND, CA 94611-2802
EXAMINER
KUNZ, GARY L
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
02/19/2015 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte Abbott Diabetes Care, Inc.
Patent Owner and Appellant
____________

Appeal 2014-004545
Reexamination Control 90/009,620
Patent 6,329,161 B1
Technology Center 3900
____________

Before RICHARD E. SCHAFER, RICHARD M. LEBOVITZ, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

ROBERTSON, Administrative Patent Judge.

DECISION ON APPEAL
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Abbott Diabetes Care, Inc., the owner of the patent under
reexamination (hereinafter the “’161 Patent”), appeals under 35 U.S.C.
§§ 134(b) and 306 from the final rejection of claims 1-4, 6-26, 28-36, and
38-57 (Appeal Brief filed June 25, 2012, hereinafter “App. Br.,” at 14; Final
Office Action mailed December 29, 2014).1 We have jurisdiction under 35
U.S.C. §§ 134(b) and 306.
We AFFIRM.

STATEMENT OF THE CASE
This reexamination proceeding arose from a third-party request for ex
parte reexamination filed by DexCom, Inc. (Request for Reexamination
Under 37 C.F.R. § 1.510 filed October 27, 2009). We are informed that the
’161 Patent along with a number of other related patents have been the
subject of a number of reexamination proceedings, and a patent infringement
action, which are identified at pages 1-3 of the Appeal Brief.
The ’161 Patent states that the invention involves in vivo enzyme
biosensors for subcutaneous measurement of glucose. (Col. 1, ll. 20-24.)
Claims 1, 15, 18, and 25 on appeal read as follows:
1. A flexible analyte sensor comprising:
a portion of the sensor that is adapted for positioning
external to the animal and for connection to a device for
measurement of the electrical signal generated by the sensor;
a portion of the sensor that is adapted for subcutaneous
implantation in an animal,

1 The rejections of claims 5, 27, and 37 have been withdrawn. See App. Br.
14, FN2; Examiner’s Answer mailed September 18, 2013, “Ans.” at 3.)
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comprising:
at least one non-corroding, analyte-responsive working
electrode; and a sensing layer coupled to the working electrode;
wherein the sensor is flexible and is adapted to provide
an electrical signal that is substantially insensitive to relative
motion between the implanted portion of the sensor and tissue
surrounding the implanted portion of the sensor.
15. The analyte sensor of claim 2,2 wherein the sensor is
adapted to provide a current signal deviating not more than
about 5% from its average value for at least 72 hours after
equilibration when glucose concentration is maintained at 10
mM.
18. A glucose measurement system comprising:
a sensor configured to generate a signal indicative of the
glucose concentration, the sensor comprising:
a non-corroding working electrode adapted for
subcutaneous implantation in an animal; and
a sensing layer comprising a non-leachable glucose-
responsive enzyme disposed on the working electrode; and
a signal measuring device operatively connected to the
sensor for measuring the signal generated by the sensor, the
signal measuring device being configured to allow the signal
generated by the sensor to reach a basal signal level for a
predetermined period of time before the signal is used as an
indicator of the glucose concentration.
25. An introduction system for a glucose sensor,
comprising:
an introducer adapted for subcutaneous placement of a
portion of a flexible glucose sensor in an animal; and
a portion of a flexible glucose sensor carried within the
sensor introducer, the portion of a flexible glucose sensor
comprising:

2 Claim 2 depends from claim 1 and recites that the analyte is glucose.
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a non-corroding working electrode adapted for
subcutaneous implantation in an animal; and
a sensing layer comprising a non-leachable, glucose-
responsive enzyme disposed on the working electrode;
wherein the introducer can be withdrawn from the animal
while leaving the portion of a flexible glucose sensor implanted
within the subcutaneous tissue of the animal.
(Claims App’x, App. Br. 41, 43-44, 45.)

In the Examiner’s Answer mailed September 18, 2013 (“Answer”),
the Examiner maintained 25 grounds of rejections for claims 1-4, 6-26, 28-
36, and 38-57, set forth in the Non-Final Action mailed March 7, 2011
(“Non-Final”) and maintained previously in the Final Rejection mailed
December 29, 2011 (“Final”), which are as follows:
I. Claims 1-3, 6-8, 11, and 30 under 35 U.S.C. § 102(b) as
anticipated by Wilson3 (Rejection 1; Non-Final 8-13);
II. Claims 4, 9, 10, 12-14, 34-36, and 38-45 under 35 U.S.C.
§ 103(a) as obvious over Wilson and certain prior art
(Rejections 2, 4-7, 22, 23, 25-27; Non-Final 13, 14, 17-22, 57-
62, 64-68);
III. Claims 1-3, 6-8, 11, 16, 17, and 30 under 35 U.S.C. § 102(b) as
anticipated by Bindra4 (Rejection 8; Non-Final 8-13);
IV. Claim 15 under 35 U.S.C. § 103(a) as obvious over Bindra
(Rejection 15; Non-Final 35-36);

3 U.S. Patent No. 5,165,407, issued Nov. 24, 1992.
4 Bindra et al., "Design and in Vitro Studies of a Needle-Type Glucose
Sensor for Subcutaneous Monitoring," Analytical Chemistry 63: 1692 -1696,
1991.
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V. Claims 4, 9, 10, 12-14, 34, and 46-48 under 35 U.S.C. § 103(a)
as obvious over Bindra in combination with certain prior art
(Rejections 9, 11-14, 28; Non-Final 27, 28, 30-34, 68-70);
VI. Claims 18, 19, 22, 25, 29, 30, 49, 52, 54, 56, and 57 under 35
U.S.C. § 102(b) as anticipated by Moatti-Sirat5 as evidenced by
Bindra (Rejection 16; Non-Final 36-47); and
VII. Claims 20, 21, 23, 24, 26, 28, 31-33, 50, 51, 53, and 55 under
35 U.S.C. § 103(a) as obvious over Moatti-Sirat as evidenced
by Bindra in combination with certain prior art (Rejections 17-
21; Non-Final 47-56).

ISSUES
There are four principal issues in this appeal:
1. Do Wilson or Bindra disclose a flexible sensor “adapted to provide
an electrical signal that is substantially insensitive to relative motion
between the implanted portion of the sensor and tissue surrounding the
implanted portion of the sensor” as recited in claim 1?
2. Does Bindra render obvious the recitation in claim 15 that “the
sensor is adapted to provide a current signal deviating not more than about
5% from its average value for at least 72 hours after equilibration when
glucose concentration is maintained at 10 mM”?
3. Does Moatti-Sirat disclose a signal measuring device “configured
to allow the signal generated by the sensor to reach a basal signal level for a

5 Moatti-Sirat et al., "Towards continuous glucose monitoring: in vivo
evaluation of a miniaturized glucose sensor implanted for several days in rat
subcutaneous tissue," Diabetologia, 35: 224 - 230, 1992.
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predetermined period of time before the signal is used as an indicator of the
glucose concentration” as recited in claim 18?
4. Does Moatti-Sirat disclose an introducer as recited in claim 25?

DISCUSSION
Issue 1-“Substantially insensitive to relative motion”
Rejection I
Patent Owner does not argue the claims separately. Accordingly, we
select claim 1 as representative.
The Examiner found that the requirement in claim 1 that the sensor is
substantially insensitive to relative motion is an inherent property of the
glucose sensor disclosed in Wilson. (Non-Final 9.) The Examiner reasoned
that the only disclosure in the ’161 Patent relating to the insensitivity of the
glucose sensor to motion relates to the recess of the sensing layer combined
with a membrane controlling glucose mass transport giving rise to
insensitivity to motion. (Non-Final 9-10.) The Examiner found that because
Wilson discloses the recessed sensing layer, Wilson discloses a flexible
glucose sensor having all the limitations of claim 1. (Non-Final 10.)
Patent Owner submitted evidence in the form of prior art references,
Moser,6 Chung,7 and Baker,8 as well as the Declaration of Benjamin J.

6 Moser et al., Biosensor arrays for simultaneous measurement of glucose,
lactate, glutamate, and glutamine, Biosensors & Bioelectronics 17, 297-302,
2002.
7 Chung et al., Reproducible fabrication of miniaturized glucose sensors:
preparation of sensing membranes for continuous monitoring, Biosensors &
Bioelectronics 16, 1079-1087, 2001.
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Feldman (“First Feldman Declaration” dated February 29, 2012), in an effort
to demonstrate that not every sensor with a recessed sensing layer and a
membrane controlling glucose mass transport is insensitive to relative
motion, and as a result, that Wilson does not disclose inherently this
limitation. (App. Br. 20.) In particular, Patent Owner contends that Baker
discloses that when a sensor including a recessed sensing layer and a
membrane controlling glucose mass transport was implanted, the
manipulation of tissue surrounding the sensor resulted in signal fluctuation
of 20%. (App. Br. 21-23; Corrected Reply Brief filed November 18, 2013
(“Rep. Br.”) 7, discussing Figure 5 of Baker.) Accordingly, Patent Owner
contends that the structural features identified by the Examiner in Wilson, do
not result inherently in a sensor that is insensitive to motion. (App. Br. 22-
23.)
After careful review and consideration of the evidence of record, we
agree with the Examiner, that the presence of a recessed sensing layer along
with a membrane controlling glucose mass transport as disclosed in Wilson
results in a signal that is substantially insensitive to relative motion.
Initially, we emphasize that although we have considered the Patent
Owner’s evidence of Chung and Moser, we find those references to be of
little support for Patent Owner’s position. As the Examiner notes, Patent
Owner has not provided much in the way of explanation as to why these two
references support its position, particularly in view of the Examiner’s
comments that Chung appears to support the opposite position, namely that

8 Baker et al., A Continuous, Implantable Lactate Sensor, Analytical
Chemistry, 67, 1536-1540, 1995.
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the sensor of Chung, which includes a diffusion limiting membrane, appears
to provide insensitivity to stirring. (Ans. 3-4.) As a result, we focus our
discussion on Baker.
Patent Owner does not dispute that Baker’s sensors include a recessed
sensing layer and a membrane controlling glucose mass transport. Baker
discloses:
Although there were fluctuations of relatively small amplitude
in the sensor signal reflecting experimental perturbations, the
concentration indicated by the sensor showed reasonable
agreement with values determined by the standard assay. The
surgical procedure was likely responsible for the initial
elevation of the lactate concentration from typical resting
values near 1.0 mM lactate. From approximately 53 to 63 min
and from 100 to 105 min, the left ventricle was manipulated
during placement of instrumentation and direct biomechanical
measurements. These procedures may account for fluctuations
in the sensor signal during these intervals, although it remains
to be determined whether all fluctuations were a result of small
lactate changes or reflections of changes in flow or other
physical phenomena.
(P. 1539, 2nd Column.)
We acknowledge that Baker discloses fluctuations in the sensor signal
following manipulation of the left ventricle during placement of the
instrumentation. (App. Br. 21.) However, Baker characterizes such
fluctuations as being of “relatively small amplitude.” Therefore, the issue
turns on whether the amount of fluctuation in the signals exhibited by Baker
as a result of the mechanical manipulation falls within an amount allowed by
the claim language “substantially insensitive to relative motion.”
The ’161 Patent provides little guidance as to the amount of
sensitivity allowed by “substantially insensitive.” The ’161 Patent discloses:
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Structure and Performance: The depth c of the channel 6 and
the thickness of the polymer layers in it controls the mass
transport, i.e., flux of glucose, to the sensing layer. By
controlling these parameters, the apparent Michaelis constant
(Km) is adjusted to about 20-30 mM glucose. The polyimide
wall 4 of the channel 6 also protects the four polymer and
polymer/enzyme layers 8, 10, 12, 14 against mechanical
damage and reduces the hazard of their loss in the body.
Because the glucose electrooxidation current is limited by
glucose mass transport through the recess 16 and its polymer
films 8, 10, 12, 14, rather than by mass transport to the tissue-
exposed tip 16, the current is practically insensitive to motion.
(Col. 11, l. 56 – col. 12, l. 1.)
The ’161 Patent discloses only that the depth of the channel and the
thickness of the polymer layers control the mass transport of glucose to the
sensing layers, and as a result, the current is “practically insensitive to
motion.” The First Feldman Declaration also is unhelpful, stating only that
one of ordinary skill in the art would be able to determine whether the sensor
of Baker was sensitive to relative motion, and that Baker does not provide a
sensor meeting that requirement of claim 1. (First Feldman Declaration,
paras. 12 and 15.)
Baker discloses that the mechanical manipulation “may account for
the fluctuations in the sensor signal during these intervals, although it
remains to be determined whether all fluctuations were a result of small
lactate changes of reflections of changes in flow or other physical
phenomena.” (Baker, p. 1539, 2nd column.) Accordingly, it is unclear
whether all of the signal difference depicted in Figure 5 of Baker is due to
the mechanical manipulation.
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Thus, even assuming that we accept Patent Owner’s contention that
Baker discloses a greater than 20% change in sensor output as a result of the
mechanical manipulation of the left ventricle, there is insufficient evidence
on this record to determine that such a change is not substantially insensitive
to relative motion. (Reply Br. 7.) The term “substantially insensitive” used
in the claim, and the term “practically insensitive” used in the Specification,
are terms of degree,9 which allow for some sensitivity to relative motion.
We have not been directed sufficient evidence that a 20% change in sensor
output would be significant in the context of blood glucose levels. In this
regard, the ’161 Patent discloses that “maintaining blood glucose levels
substantially, e.g., approximately 40% or more above normal leads to
retionopathy and blindness as well as to kidney failure.” (Col. 7, ll. 2-24.)
Such levels are double than the alleged difference in lactate levels disclosed
in Baker of 20%.
Accordingly, we agree with the Examiner that Wilson discloses
implanted sensors that are substantially insensitive to relative motion as a
result of including a recessed sensing layer and a membrane controlling
glucose mass transport. As a result, we affirm the Examiner’s decision to
reject claim 1 as anticipated by Wilson.

9 “Practically” is defined as “all but; nearly; almost.”
http://www.thefreedictionary.com/practically. “Substantially is defined as
“Considerable in importance, value, degree, amount, or extent.”
http://www.thefreedictionary.com/substantially.

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Rejection II
Because Rejection II relies on the Examiner’s position with respect to
Wilson as to the “substantially insensitive” limitation (App. Br. 26), and
Patent Owner does not present any additional arguments regarding the
patentability of these claims, we affirm Rejection II for similar reasons as
discussed above.

Rejections III and V
Both the Examiner and Patent Owner rely on the same positions
relative to the “substantially insensitive” limitation for the Rejections based
on Bindra. (Ans. 9; App. Br. 27-28, 31.) Accordingly, the Examiner’s
rejections are affirmed for the same reasons as discussed above with respect
to Wilson.

Issue 2-Current Signal Deviation
Rejection IV
Claim 15 recites that “the sensor is adapted to provide a current signal
deviating not more than about 5% form [sic] its average value for at least 72
hours when the glucose concentration is maintained at 10 mM.” The
Examiner’s position is that Bindra discloses this limitation. The Examiner
found that Bindra teaches that the glucose sensitivity ranged from 4.0 to 4.3
nA/mM/mm2 over a seven day period, with average sensitivity value being
equal approximately 4.1 nA/mM/mm2 leading to a variance of between -
2.4% and 4.87%, a value less than about 5%. (Non-Final 35; Final 18, citing
Bindra page 1695, Fig. 3, and Table 5.) As a result, the Examiner found that
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the sensor did not deviate more than 5% from its average value for at least
168 hours. (Non-Final 35; Final 18.) The Examiner stated that the only
difference in the limitation of claim 15 and the test conditions disclosed by
Bindra is the concentration of the glucose during the stability test, which is
10 mM glucose in claim 15 as opposed to 5.5 mM glucose in Bindra. (Non-
Final 35; Final 18.) The Examiner concluded that a person of ordinary skill
in the art would have found the invention of claim 15 defined by a variation
of signal of less than 5% obvious over Bindra, because Bindra discloses
similar stability at a lower glucose concentration and there would have been
motivation to establish stability at higher concentrations as part of any
quality control study. (Non-Final 35-36; Final 18.) The Examiner further
acknowledged that Bindra calibrates the sensors once a day, but that even
assuming calibration of the sensors lasted about an hour, the sensor was in
5.5 mM glucose for 96% of the time, or 171 hours. (Ans. 10-11.)
Patent Owner contends that Bindra does not disclose determining the
variation of sensor signal at a lower glucose concentration as required in
claim 15, but rather discloses sensors exposed to varying glucose
concentrations every single day during the seven day test period. (App. Br.
30.) Specifically, Patent Owner contends that Bindra discloses a seven day
test period where the sensor is subject to increasing glucose concentration
and sometimes to stable concentrations. (App. Br. 30.) As a result, Patent
Owner argues that there is no suggestion or disclosure in Bindra that the
sensor’s sensitivity to glucose should be measured at a continuously stable
glucose concentration for 72 hours. (App. Br. 30-31.) Patent Owner
contends that the storage period lasted less than a day between each
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calibration and therefore the sensor is not maintained at any stable glucose
concentration for even one day, which is less than the 72 hours recited in the
claim. (Reply Br. 12.) Patent Owner also points out that according to Table
5, the difference between sensitivity jumps from 4.0 on days 2-4 to 4.3 on
day 5, which is a difference of more than 5%. (Reply Br. 12.) Last, Patent
Owner contends that the data reported in Bindra are snapshots of a sensor at
a particular point in time and not current signal as required in claim 15.
(Reply Br. 12.)
We agree with the Examiner. Bindra discloses expressly that the
operational stability of the sensor was evaluated by running a sensor
calibration over a 7-day period. (Page 1695, Fig. 3, Table V.) The
Examiner’s calculations demonstrate that the sensor was within the 5%
variation recited in the claim for the 7-day period. In this regard, we do not
agree with the Patent Owner that the difference exceeds the 5% limit. Claim
15 recites that the % difference is relative to the average value. In this case,
the Examiner properly determined the average value over the entire 7 day
period used in Bindra. The difference in glucose concentration between
days 2 to 4 and day 5 do not amount to over 5% in view of this average.
Patent Owner looked at the differences between days, not with respect to the
average of the 7-day period. (Reply Br. 12.)
We also are not persuaded by Patent Owner’s argument that Bindra
does not show continuous stability over the time period recited in the claim
due to the time associated with calibration and because there is no potential
applied during the storage period. We understand Patent Owner’s argument
to be that due to the extent of the monitoring in Bindra, it is unclear whether
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the current signal would meet the recited stability requirements. We
disagree. Bindra demonstrates the stability of the glucose sensor over a
seven day period. Patent Owner provides insufficient evidence to support
the position that in the time the sensor is not being monitored, the sensor
would exhibit more than the 5% variation allowed by the claim.
Last, Patent Owner has not argued that the glucose concentration
monitored in Bindra (5.5 mmol/L) versus the concentration of 10 mM,
would result in a different expectation in the stability of the sensor. Indeed,
Bindra discloses that sensors stored at 0.1 M PBS were also stable under
different conditions. (See Bindra, Fig. 3.)
Accordingly, we affirm the Examiner’s decision to reject claim 15 as
obvious over Bindra.

Issue 3- “Predetermined Period of Time”
Rejection VI
Patent Owner presents separate arguments with respect to claims 18
and 25. Accordingly, we limit our discussion of Rejection VI to these
claims.
Claim 18
The Examiner found that Moatti-Sirat discloses a glucose
measurement as claimed in claim 18. (Non-Final 36-37.) In particular, the
Examiner found that Moatti-Sirat discloses a “run-in-period” of 2-6 hours
after subcutaneous implantation before achieving a stable current, which the
Examiner contends corresponds to the signal device being configured to
allow the signal generated by the sensor to reach a basal signal level for a
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predetermined period of time, as recited in claim 18. (Id.) The Examiner’s
position is that in order to meet this limitation, the signal device is
constructed to have an electronic system that automatically waits for a
predetermined period of time before displaying the glucose concentration, or
the user waits a predetermined period of time before using the signal as a
valid indicator of glucose concentration. (Ans. 12-13.) The Examiner
further states that once a researcher has determined that it takes from 2 to 6
hours for a stable current to emerge, the researcher will wait from 2 to 6
hours in subsequent experiments. (Ans. 14-15.)
Patent Owner contends that the run-in time disclosed in Moatti-Sirat is
not a predetermined period of time, but rather a variable amount of time
between 2 and 6 hours for each individual sensor until a stable current was
reached. (App. Br. 32-34.) Thus, Patent Owner contends that the researcher
in Moatti-Sirat would be waiting for the event of a stable signal, whenever
that occurred, which does not meet the claimed limitation of waiting for a
predetermined period of time. (Reply Br. 15.)
We agree with the Examiner that Moatti-Sirat discloses the limitation
of waiting for a predetermined period of time. Moatti-Sirat discloses “[a]
run-in period (2 to 6 h) was required to obtain a stable current before
performing the glucose test….” (Page 225, 1st column.) Thus, Moatti-Sirat
informs one of ordinary skill in the art to wait a predetermined period of
time, at least two hours, before performing the glucose test. Similarly, the
’161 Patent discloses that “[t]he sensors were allowed to reach a basal signal
level for at least one hour before blood sampling was started.” (Col. 13, ll.
48-50.) The ’161 Patent discloses this period of time in the context of an
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experiment directed to the in vivo use of the sensor in rats. (Col. 13, ll. 10-
57.) Thus, to the extent the time period of “at least one hour” disclosed in
the ’161 Patent is “predetermined,” the time period in Moatti-Sirat also is
predetermined.
Although the Second Feldman Declaration states that one of ordinary
skill in the art would have understood from claim 18 that the time period to
allow a sensor to reach a basal signal level would have been predetermined,
the Feldman Declaration does not provide support for this reading and does
not point to how one of ordinary skill in the art would have understood this
limitation in light of the specification. (Second Feldman Declaration, para.
10.)
Accordingly, we agree with the Examiner, that the pre-determined
amount of time is determined experimentally, and corresponds to the 2 to 6
hour run-in period disclosed by Moatti-Sirat.

Issue 3-Introducer
Claim 25
Claim 25 recites “a portion of a flexible glucose sensor carried within
the sensor introducer.” The Examiner found that Moatti-Sirat discloses an
introducer (cannula) that is used to insert a flexible glucose sensor in a rat,
and that Moatti-Sirat discloses further that the cannula is removed leaving a
portion of the sensor subcutaneously implanted. (Non-Final 38; Ans. 25.)
The Examiner stated that it is not clear whether a portion of the glucose
sensor is inside the cannula, but that there are only two possibilities:
inserting the introducer alone into the tissue followed by sensor insertion; or
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inserting the introducer into the tissue with the sensor already inside, either
option being at once envisaged by the person of skill in the art. (Non-Final
39-40.) The Examiner emphasized also that claim 25 is an apparatus claim,
such that the cannula disclosed in Moatti-Sirat only need be capable of
carrying a portion of the sensor. (Final 23; Ans. 16-17.)
Patent Owner contends that the Office has not provided support to its
assertion that there are only two ways to accomplish the insertion of the
sensor, and that Moatti-Sirat does not expressly or inherently teach that the
portion of the sensor is carried within the sensor introducer. (App. Br. 36-
37.) Patent Owner argues that the recitation that “a portion of a flexible
glucose sensor carried within the sensor introducer” is structural language,
which is not disclosed by Moatti-Sirat. (Reply Br. 15-16.)
Initially, we agree with Patent Owner that the claim limitation imparts
structural requirement to the system. That is, the claim requires a sensor to
be within the sensor introducer. However, because the claim recites a
system and not a series of steps performed in any particular order, we
interpret the claim limitation that the sensor is “carried within” the sensor
introducer to require that the sensor be located inside the introducer at some
point. Indeed, the ’161 Patent states only that the “[s]ensors were then
implanted subcutaneously using a 22 gauge Per-Q-Cath Introducer . . . on
the rat’s thorax, or subcutaneously in the intrascepular area through a small
surgical incision.” (Col. 13, ll. 34-37.) Thus, our interpretation is consistent
with the disclosure in the ’161 Patent.
Moatti-Sirat discloses that “a sensor was implanted . . . through a 16
gauge cannula. The cannula was then removed, leaving the sensor in place
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secured with adhesive plaster.” (P. 225, left column.) Thus, Moatti-Sirat
discloses “a portion of a flexible glucose sensor carried within the sensor
introducer” because the sensor is implanted through the cannula, and as a
result, a portion of the sensor must be carried within the sensor introducer at
least during the time it is introduced into the animal. Accordingly, the
disclosure of Moatti-Sirat regarding implantation of the sensor is similar to
the ’161 Patent. Thus, under either of the two possibilities for implanting
the sensor identified by the Examiner, or under some other procedure as
suggested by Patent Owner, the claim limitation is met. Moatti-Sirat
expressly discloses implanting the sensor through a cannula, which requires
that a portion of the sensor be carried within the introducer. Patent Owner
does not provide sufficient explanation or evidence as to why Moatti-Sirat
does not disclose the limitation at issue in view of the interpretation that
claim 25 recites a structural relationship between the sensor and sensor
introducer. (Reply Br. 15-16.)

Rejection VII
Patent Owner does not present any other arguments besides those
addressed above for the other rejections based on Moatti-Sirat and Bindra.
(App. Br. 37-39.) Accordingly, we affirm the Examiner’s rejections for
similar reasons as addressed above.

CONCLUSION
On this record, Appellant has failed to demonstrate any error in the
Examiner’s factual findings and conclusions that:
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Wilson or Bindra disclose a flexible sensor “adapted to provide an
electrical signal that is substantially insensitive to relative motion between
the implanted portion of the sensor and tissue surrounding the implanted
portion of the sensor” as recited in claim 1;
Bindra renders obvious the recitation in claim 15 that “the sensor is
adapted to provide a current signal deviating not more than about 5% from
its average value for at least 72 hours after equilibration when glucose
concentration is maintained at 10 mM”;
Moatti-Sirat discloses a signal measuring device “configured to allow
the signal generated by the sensor to reach a basal signal level for a
predetermined period of time before the signal is used as an indicator of the
glucose concentration” as recited in claim 18; and
Moatti-Sirat discloses an introducer as recited in claim 25.

DECISION
The Examiner’s decision to reject claims 1-4, 6-26, 28-36, and 38-57
is affirmed.
Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).

AFFIRMED

Appeal 2014-004545
Reexamination Control 90/009,620
Patent 6,329,161 B1

20
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