Ex Parte Shah et al

Patent Trial and Appeal Board

Apr 26, 2016

11493054 (P.T.A.B. Apr. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111493,054 0712612006 Rajiv Shah
12813 7590 04/27/2016
Gates & Cooper LLP - Minimed
6701 Center Drive West
Suite 1050
Los Angeles, CA 90045
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
G&C 130.80-US-Ol 7773
EXAMINER
JANG, CHRISTIAN YONGKYUN
ART UNIT PAPER NUMBER
3735
MAILDATE DELIVERY MODE
04/27/2016 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 RAJIV SHAH, UDO HOSS, GOPIKRISHNAN
SOUNDARARAJAN, NANNETTE M. VAN ANTWERP, and
BARRYPHAM1
Appeal2014-004753
Application 11/493,054
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods and systems for stabilizing analyte sensors. The claims are rejected
as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 According to Appellants, the Real Party in Interest is Medtronic MiniMed,
Inc. (App. Br. 1 ).
Appeal2014-004753
Application 11/493,054
STATEMENT OF THE CASE
Appellants' invention "relates generally to the manufacture and use of
sensor systems suitable for subcutaneous implantation, intravenous use, and
other placements involving direct contact between the sensor and the tissue
or fluid to be sampled" (Spec. i-f 2). Claims 1, 2, 4, 9, 10, 13, 14, 16-22, 24,
26, and 29-34 are on appeal. Claim 1 is illustrative and reads as follows
(emphasis added):
1. A sensor system comprising:
a sensor having a chemically reactive surface that
reacts with an analyte to be sensed; and
a cannula comprising:
a substantially cylindrical housing that surrounds
the sensor;
at least one aperture disposed in the housing that
allows the analyte to diffuse therethrough so as to
contact the chemically reactive surface;
an end that extends beyond an end of the sensor;
an accessory material provided in proximity to the
chemically reactive surface, wherein:
the accessory material fills the at least one
aperture of the cannula;
the accessory material is disposed in the aperture
such that a surface of the accessory material is
substantially flush with a surface of the cannula;
and
the sensor system is adapted to contact a tissue
such that the accessory material is configured to
contact and modify a biological response of the
tissue.
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Appeal2014-004753
Application 11/493,054
The claims stand rejected as follows:
I. Claims 1, 4, 9, 17-22, 24, 29-31, and 33 stand rejected under
35 U.S.C. § 103(a) as being obvious based on Mcivor,2 Blubaugh,3 and
Rhodes. 4
II. Claim 2 stands rejected under 35 U.S.C. § 103(a) as being
obvious based on Mcivor, Blubaugh, Rhodes, and Mastrototaro. 5
III. Claims 10, 32, and 34 stand rejected under 35 U.S.C. § 103(a)
as being obvious based on Mcivor, Blubaugh, Rhodes, and Uchiyama. 6
IV. Claims 13, 14, 16, and 26 stand rejected under 35 U.S.C.
§ 103(a) as being obvious based on Mcivor, Blubaugh, Rhodes, and
Nikolchev.7
I.
The Examiner has rejected claims 1, 4, 9, 17-22, 24, 29-31, and 33
under 35 U.S.C. § 103(a) as being obvious based on Mcivor, Blubaugh, and
Rhodes. We focus our discussion on independent claims 1, 21, and 30.
We agree with Appellants that the Examiner erred in rejecting claims
1, 21, and 30 as being obvious based on Mcivor, Blubaugh, and Rhodes.
Independent claims 1, 21, and 30 recite an "accessory material" that
"fills the at least one aperture of the cannula," and "is disposed in the
aperture such that a surface of the accessory material is substantially flush
with a surface of the cannula."
2 Mcivor et al., US 2002/0023852 Al, published Feb. 28, 2002.
3 Blubaugh, Jr. et al., US 5,914,026, issued June 22, 1999.
4 Rhodes et al., US 2003/0032874 Al, published Feb. 13, 2003.
5 Mastrototaro, US 5,299,571, issued Apr. 5, 1994.
6 Uchiyama, US 2002/0031532 Al, published Mar. 14, 2002.
7 Nikolchev, US 6,336,904 Bl, issued Jan. 8, 2002.
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Appeal2014-004753
Application 11/493,054
We agree with the Examiner that Rlubaugh teaches an enzyme-
containing membrane that fills an aperture, preventing direct contact
between the sensor electrodes and the tissue (Ans. 3; citing Blubaugh
Fig. 4). Nevertheless, we disagree with the Examiner's conclusion that it
would have been obvious to use Blubaugh's enzyme-containing membrane
to fill the window of Mcivor' s cannula in order to arrive at Appellants'
claimed invention (Final Act. 3).
Figure 7 of Mcivor is reproduced below:
flG. 7
(Mcivor, Fig. 7.) Figure 7 depicts a cross-section of cannula 16, disclosed
by Mcivor (id. at i-f 63). In describing cannula 16, Mcivor teaches that "[a]t
least one window 22 is formed in the lumen 50 near the implanted end 54, in
general alignment with the sensor electrodes 20, to permit direct electrode
exposure to the user's bodily fluid when the sensor 12 is subcutaneously
placed" (id. at [0063]).
Blubaugh does not, however, contemplate using its enzyme-
containing membrane to form a cannula wall, as would be required by the
proposed combination. The Examiner fails to explain how or why
Blubaugh's enzyme-containing membrane would be used to fill the window
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Appeal2014-004753
Application 11/493,054
ofMcivor's cannula, and thereby, form a wall of the cannula when Mcivor
teaches sensors that are encased in insulative materials and requires
exposure of the sensor electrodes with bodily fluid upon insertion (Mcivor
i-f 59). This rebuts the Examiner's reason to combine Blubaugh with Mcivor
in order to "prevent direct contact between the electrodes and tissue" (Final
Act. 3) because Mcivor requires direct contact (Mcivor i-f 59). "We must
still be careful not to allow hindsight reconstruction of references to reach
the claimed invention without any explanation as to how or why the
references would be combined to produce the claimed invention."
Innogenetics, N. V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir.
2008).
Accordingly, we conclude that the Examiner has not established an
evidentiary basis on this record to support a conclusion that the combination
of Mcivor, Blubaugh, and Rhodes render obvious "the accessory material
fills the at least one aperture of the cannula," and "the accessory material is
disposed in the aperture such that a surface of the accessory material is
substantially flush with a surface of the cannula," as are required by claims
1, 21, and 30. Because they depend from claim 1, the rejection of claims 4,
9, and 17-20 is also reversed. Because they depend from claim 21, the
rejection of claims 22, 24, 26, and 29-31 is also reversed. Because they
depend from claim 30, the rejection of claim 33 is also reversed.
II.
The Examiner has rejected claim 2 under 35 U.S.C. § 103(a) as being
obvious based on Mcivor, Blubaugh, Rhodes, and Mastrototaro. Because
the Examiner has pointed to no clear or specific teaching in Mastrototaro
that addresses the deficiencies discussed above of Mcivor, Blubaugh, and
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Appeal2014-004753
Application 11/493,054
Rhodes with respect to claim 1, from which claim 2 depends, we reverse this
rejection as well.
III.
The Examiner has rejected claims 10, 32, and 34 under 35 U.S.C.
§ 103(a) as being obvious based on Mcivor, Blubaugh, Rhodes, and
Uchiyama. Because the Examiner has pointed to no clear or specific
teaching in Uchiyama that addresses the deficiencies discussed above of
Mcivor, Blubaugh, and Rhodes with respect to claims 1, 21, and 30, from
which claim 10, 32, and 34 depend, respectively, we reverse this rejection as
well.
IV.
The Examiner has rejected claims 13, 14, 16, and 26 under 35 U.S.C.
§ 103(a) as being obvious based on Mcivor, Blubaugh, Rhodes, and
Nikolchev. Because the Examiner has pointed to no clear or specific
teaching in Nikolchev that addresses the deficiencies discussed above of
Mcivor, Blubaugh, and Rhodes with respect to claims 1 and 21, from which
claim 13, 14, 16, and 26 depend, respectively, we reverse this rejection as
well.
SUMMARY
We reverse the rejection of claims 1, 4, 9, 17-22, 24, 29-31, and 33
under 35 U.S.C. § 103(a) based on Mcivor, Blubaugh, and Rhodes.
We reverse the rejection of claim 2 under 35 U.S.C. § 103(a) based on
Mcivor, Blubaugh, Rhodes, and Mastrototaro.
We reverse the rejection of claims 10, 32, and 34 under 35 U.S.C.
§ 103(a) based on Mcivor, Blubaugh, Rhodes, and Uchiyama.
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Appeal2014-004753
Application 11/493,054
We reverse the rejection of claims 13, 14, 16, and 26 under 35 U.S.C.
§ 103(a) based on Mcivor, Blubaugh, Rhodes, and Nikolchev.
REVERSED
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