Ex Parte Gottlieb et al

Patent Trial and Appeal Board

Jan 31, 2017

12184046 (P.T.A.B. Jan. 31, 2017)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
12/184,046 07/31/2008 Rebecca K. Gottlieb G&C 130.92-US-01 6638
12813 7590 01/31/2017
Gates & Cooper LLP - Minimed
6701 Center Drive West
Suite 1050
Los Angeles, CA 90045
EXAMINER
WESTON, TIFFANY C
ART UNIT PAPER NUMBER
3735
MAIL DATE DELIVERY MODE
01/31/2017 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 REBECCA K. GOTTLIEB, RAJIV SHAH,
KATHERINE T. WOLFE, GOPIKRISHNAN SOUNDARARAJAN,
KENNETH W. COOPER, RATNAKAR VELJELLA, ENJOO JIN,
BRIAN T. KANNARD, and JOHN J. MASTROTOTARO
____________________

Appeal 2015-002483
Application 12/184,046
Technology Center 3700
____________________

Before JOHN C. KERINS, STEFAN STAICOVICI, and LEE L. STEPINA,
Administrative Patent Judges.

KERINS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Rebecca K. Gottlieb et al. (Appellants) appeal under 35 U.S.C.
§ 134(a) from the Examiner’s final decision rejecting claims 4–6, 9, 10, 12–
18, and 20–58. We have jurisdiction over this appeal under 35 U.S.C.
§ 6(b).
We AFFIRM.

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Application 12/184,046

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THE INVENTION
Appellants’ invention relates to analyte sensors.
Claim 58, the sole independent claim, is representative of the claimed
invention and reads as follows:
58. An analyte sensor apparatus for implantation within a
mammal, the analyte sensor apparatus comprising:

an elongated base layer having a planar surface;

a conductive layer disposed on the base layer and
comprising a plurality of reference electrodes, a plurality of
working electrodes and a plurality of counter electrodes,
wherein:

the plurality of working electrodes, the plurality of
counter electrodes and the plurality of references electrodes are
parallel to the planar surface of the elongated base layer when
the analyte sensor apparatus is implanted within the mammal;

the plurality of working electrodes, the plurality of
counter electrodes and the plurality of references electrodes are
clustered together in units consisting essentially of one working
electrode, one counter electrode and one reference electrode;
and

the clustered units are longitudinally distributed on the
elongated base layer in a repeating pattern of units;

an analyte sensing layer disposed on the conductive
layer; and

an analyte modulating layer disposed on the analyte
sensing layer, wherein the analyte modulating layer comprises a
composition that modulates the diffusion of an analyte diffusing
through the analyte modulating layer.

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THE REJECTIONS
The Examiner has rejected:
(i) Claims 4–6, 9, 12, 21–24, 26–29, 33–38, 46–48, and 56–58
under 35 U.S.C. § 103(a) as being unpatentable over Shah (US
2006/0004272 A1, published Jan. 5, 2006) and Daddona (WO 98/046124
A1, published Oct. 22, 1998).
(ii) Claims 13–16, 40, 41, 43, and 44 under 35 U.S.C. § 103(a) as
being unpatentable over Shah, Daddona, and Nankai (US 5,120,420, issued
June 9, 1992).
(iii) Claim 10 under 35 U.S.C. § 103(a) as being unpatentable over
Shah, Daddona, and Yoshioka (US 5,192,415, issued Mar. 9, 1993).
(iv) Claims 17, 18, and 20 under 35 U.S.C. § 103(a) as being
unpatentable over Shah, Daddona, and Brauker (US 2007/0208244 A1,
published Sept. 6, 2007).
(v) Claim 25 under 35 U.S.C. § 103(a) as being unpatentable over
Shah, Daddona, and Shah (US 2007/0227907 A1, published Oct. 4, 2007,
hereinafter “Shah ’907”).
(vi) Claims 30 and 31 under 35 U.S.C. § 103(a) as being
unpatentable over Shah, Daddona, and Holker (US 2002/0032374 A1,
published Mar. 14, 2002).
(vii) Claim 32 under 35 U.S.C. § 103(a) as being unpatentable over
Shah, Daddona, and Cui (US 2005/0000808 A1, published Jan. 6, 2005).
(viii) Claim 39 under 35 U.S.C. § 103(a) as being unpatentable over
Shah, Daddona, and Neel (US 2005/0143675 A1, published June 30, 2005).
(ix) Claim 42 under 35 U.S.C. § 103(a) as being unpatentable over
Shah, Daddona, Nankai, and Yoshioka.
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(x) Claim 45 under 35 U.S.C. § 103(a) as being unpatentable over
Shah, Daddona, Nankai, and Surridge (US 2003/0155237 A1, published
Aug. 21, 2003).
(xi) Claims 49–54 under 35 U.S.C. § 103(a) as being unpatentable
over Shah, Daddona, and Wang (US 2007/0170073 A1, published July 26,
2007).
(xii) Claim 55 under 35 U.S.C. § 103(a) as being unpatentable over
Shah, Daddona, Wang, and Yoshioka.

ANALYSIS
Rejection (i)--claims 4–6, 9, 12, 21–24, 26–29, 33–38, 46–48, and 56–58--
§ 103(a)
Appellants advance arguments directed solely to independent claim
58, and do not present arguments for the separate patentability of any of the
remaining claims subject to this rejection. Accordingly, we take claim 58 as
representative, and claims 4–6, 9, 12, 21–24, 26–29, 33–38, 46–48, 56 and
57 stand or fall with claim 58.
Claim 58 requires that a plurality of working electrodes, a plurality of
counter electrodes, and a plurality of reference electrodes (1) are parallel to
the planar surface of the elongated base layer when the analyte sensor
apparatus is implanted within the mammal, and (2) are clustered together in
units consisting essentially of one working electrode, one counter electrode
and one reference electrode. See Appeal Br. 15 (Claims App.).
The Examiner finds that Shah discloses most of the limitations of
claim 58 including that the working electrodes, counter electrodes, and
reference electrodes are parallel to the base layer. Final Act. 3 (citing Shah,
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para. 48; Figs. 2–5). The Examiner relies on Daddona as teaching an analyte
sensor with a plurality of electrodes, wherein counter, working, and
reference electrodes are clustered together as units that are distributed on the
base layer. Id. (citing Daddona, p. 5, l. 1–p. 7, l. 28; Figs. 3 and 4). The
Examiner notes that although Daddona uses microprotrusions, Daddona is
not limited to this use, and rather, broadly teaches a “need for a plurality of
working, counter, and reference electrodes for blood analyte detection.” Id.
at 3–4 (citing Daddona, p. 11, ll. 8–11). The Examiner thus concludes that it
would have been obvious to modify Shah so as to include a plurality of
electrode units having working, counter, and reference electrodes, as taught
by Daddona, in order to provide for redundancy and accuracy, and in that
doing so amounts to the use of a known technique to improve a similar
device in the same way. Id. at 4.
Appellants argue that because Daddona teaches that the electrodes
extend outward from (e.g., are perpendicular to) the planar surface of the
sensor base, Daddona teaches away from an analyte sensor apparatus
designed so that electrodes are parallel to the planar surface of the elongated
base layer. Appeal Br. 5. Appellants assert that Daddona further teaches
that this projection/perpendicular orientation of the microprotrusions is
required “in order for the sensor electrodes to contact a patient’s interstitial
fluid when the analyte sensor is implanted.” Id. at 6 (citing Daddona p. 5, ll.
9–23).
The Examiner responds that Daddona is not being relied on for the
orientation of the microprotrusions of the electrodes, that “Daddona is relied
upon to teach the cluster of electrodes” and that “Daddona does not teach
away from using the electrodes in a cluster on a base layer as in Shah.” Ans.
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4. The Examiner additionally confirms that Shah is relied on as teaching the
provision of electrodes in a conductive layer that is parallel to the base layer.
Id.
In reply, Appellants reiterate that the protruding/perpendicular
electrode microprotrusion orientation of Daddona is required, otherwise the
electrodes would no longer be able to contact a patient’s interstitial fluid and
sense analyte. Reply Br. 6. Appellants also argue that the Examiner’s
motivation to modify Shah based on Daddona, namely, to provide for
redundancy and accuracy, does not consider the problem that Shah seeks to
address, i.e., biofouling, and “is therefore inconsistent with the structure of
the Shah invention.” Id.
Appellants’ arguments directed to the perpendicular orientation of the
microprotrusions in Daddona are not indicative of error in the rejection
because, Daddona is not relied on for the orientation of the microprotrusions,
and instead, is relied on for the electrodes being in a cluster. Ans. 4. Shah
discloses that the counter and reference electrodes may be implanted
proximate to the working electrode. See id. para. 59; see also Ans. 4. The
Examiner is modifying this configuration so that the electrodes oriented as
disclosed in Shah are arranged in a cluster, the concept of clustering a group
of working, counter, and reference electrodes being taken from Daddona.
See Ans. 4. Appellants do not explain adequately why Shah’s arrangement
of parallel electrodes would not work in a cluster arrangement.
Appellants’ “teaching away” argument also fails to apprise us of error
in the rejection, in that Appellants have not pointed to any portion of
Daddona that criticizes, discredits, or otherwise discourages the claimed
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subject matter or the Examiner’s modification to Shah in view of Daddona.
In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
Finally, although we appreciate that Shah addresses biofouling by
using a controllable membrane so that “one or more of the plurality of
analyte sensor elements may be activated (e.g. exposed to analyte) at
different times so as to extend the useful life of the sensor” (Shah, paras. 10
and 15), Appellants do not explain adequately why the Examiner’s proposed
modification would compromise this feature of the Shah device. A person
of ordinary skill in the art would readily appreciate that each cluster of
electrodes in the device of Shah, as modified by Daddona, would be
sequentially exposed in order to address biofouling and improve
redundancy. For these reasons, Appellants do not apprise us of error on
behalf of the Examiner.
Accordingly, we sustain the rejection of claim 58 under 35 U.S.C.
§ 103(a) as being unpatentable over Shah and Daddona. Claims 4–6, 9, 12,
21–24, 26–29, 33–38, 46–48, 56 and 57 fall with claim 58.

Rejections (ii)–(xii)--claims 10, 13–18, 20, 25, 30–32, 39–45, and 49–55--
§103(a)
Appellants do not present any additional substantive arguments
directed to the rejections of claims 10, 13–18, 20, 25, 30–32, 39–45, and 49–
55. Appellants merely argue essentially that these claims are allowable over
the teachings of Shah, Daddona, Nankai, Yoshioka, Brauker, Shah ’907,
Holker, Cui, Neel, Surridge, and Wang, in various combinations, because
they depend from independent claim 58. Appeal Br. 7. Accordingly, the
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rejections of claims 10, 13–18, 20, 25, 30–32, 39–45, and 49–55 are
sustained for the same reasons noted above with respect to Rejection (i).

DECISION
The rejections of claims 4–6, 9, 10, 12–18, and 20–58 under 35
U.S.C. § 103(a) are affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED