Ex Parte Aeschilimann et al

Patent Trial and Appeal Board

Apr 26, 2016

12641911 (P.T.A.B. Apr. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/641,911 12/18/2009 Reto Aeschilimann
67491 7590 04/28/2016
DINSMORE & SHOHL, LLP
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DAYTON, OH 45402
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ATTORNEY DOCKET NO. CONFIRMATION NO.
ROJ 0016 PA/25483 US 1538
EXAMINER
BOSQUES, EDELMIRA
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
04/28/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
daytonipdocket@dinsmore.com
pair_roche@firsttofile.com
PTOL-90A (Rev. 04/07)
~UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RETO AESCHILIMANN
and JAMES LEUENBERGER1, 2
Appeal2014-004352
Application 12/641,911
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 an
infusion device with an impedance measuring unit. The claims are rejected
as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 The Appeal Brief is not paginated. Therefore, all references to page
numbers in the Appeal Brief refer to page numbers as if the Appeal Brief
was numbered consecutively beginning with the first page.
2 According to Appellants, the Real Party in Interest is Roche Diagnostics
International AG (App. Br. 2).
Appeal2014-004352
Application 12/641,911
STATEMENT OF THE CASE
Appellants' invention relates to "ambulatory infusion devices for the
infusion of a liquid drug into a patient's body" (Spec. i-f 2) that measure and
evaluate at least one impedance value between at least two electrodes (Spec.
i-f 5). Claims 1-15 are on appeal. Claim 1 is illustrative and reads as follows
(emphasis added):
1. An ambulatory infusion device for the infusion of a liquid
drug into a patient's body over an extended time period,
compnsmg:
a) an infusion cannula designed to be placed m the
patient's subcutaneous tissue;
b) at least two subcutaneous electrodes, the at least two
subcutaneous electrodes being comprised by the infusion
cannula and being placed in the subcutaneous tissue;
c) an impedance measuring unit, the impedance measuring
unit being operatively coupled to the at least two electrodes and
configured to measure at least one impedance value between the
at least two electrodes, a variation of the at least one impedance
value reflecting a displacement of interstitial fluid by drug upon
drug administration;
d) an event trigger unit operatively coupled to the
impedance measuring unit and being configured to evaluate the
at least one impedance value and to generate an event trigger if
evaluation of the at least one impedance value indicates the
occurrence of an administration anomaly.
The claims stand rejected as follows:
I. Claims 1-8 and 10-13 stand rejected under 35 U.S.C. § 103(a)
as being obvious based on Steil3 and Polychronakos.4
3 Steil et al., US 2003/0130616 Al, published July 10, 2003.
4 Polychronakos et al., US 2004/0108226 Al, published June 10, 2004.
2
Appeal2014-004352
Application 12/641,911
II. Claim 9 stands rejected under 35 U.S.C. § 103(a) as being
obvious based on Steil, Polychronakos, and Ben-David. 5
III. Claims 14 and 15 stand rejected under 35 U.S.C. § 103(a) as
being obvious based on Steil, Polychronakos, and Ben-David.
I.
The Examiner has rejected claims 1-8 and 10-13 under 35 U.S.C.
§ 103(a) as being obvious based on Steil and Polychronakos. We focus our
discussion on independent claims 1 and 12.
We agree with Appellants that the Examiner erred in rejecting claim 1
as being obvious over Steil and Polychronakos.
Claims 1 and 12 recite "the at least two subcutaneous electrodes being
comprised by the infusion cannula."
The Examiner finds that Steil teaches an infusion cannula (Ans. 2-3)
and asserts that "the examiner is considering the [claimed] infusion cannula
to be the cannula 58 [of Steil], because this cannula is designed to be placed
in the patient's subcutaneous tissue as claimed, [and] also this cannula
comprises at least two subcutaneous electrodes (42), as required by the
claim[ s ]" (Ans. 11 ).
As Appellants point out, however, Steil describes distinct infusion and
sensor systems, and Steil teaches an infusion cannula that is part of the
infusion device, and entirely separate from the insertion needle used to place
the sensor, which the Examiner identifies as an infusion cannula (App.
Br. 3--4, 9-10; Reply Br. 2-3).
5 Ben-David et al., US 2006/0206155 Al, published Sept. 14, 2006.
3
Appeal2014-004352
Application 12/641,911
Figure 2 of Steil is reproduced below:
~;;) ----- ..
Zi;,=:~:~)
I'
i[i······q
'---· -- ~.f:
(~;: .• ~,~8
\\--. __ l~
\ ~
:,
' '
''
FIG. 2
~ . ~-
(Steil, Figure 2.) As shown in Figure 2, infusion set 38, which includes
cannula 56, is structurally distinct from sensor set 28, which includes sensor
26 (id. at iTiT 96-97).
Steil teaches that "cannula 56 extends through the skin 46 and
terminates in the subcutaneous tissue 44 completing fluid communication
between the reservoir 50 and the subcutaneous tissue 44 of the user's body
16" (id. at iT 97). Steil further teaches that "the infusion device 34 delivers
insulin through the cannula 56" (id. at iT 128). Neither sensor 26, nor any
other sensor is disclosed as being comprised by cannula 56 (see, e.g., id. at
iTiT 97' 128, 318).
In contrast, Steil explains that "insertion needle 58," identified by the
Examiner as reading on the infusion cannula of claims 1 and 12, is used to
insert sensor 26 through the user's skin, and subsequently "removed and
4
Appeal2014-004352
Application 12/641,911
disposed of once the sensor is positioned in the subcutaneous tissue" (id. at
iT 318).
We, therefore, agree with Appellants that Steil' s insertion needle is
not an infusion cannula (Reply Br. 2-3), and conclude that the Examiner has
not established an evidentiary basis on this record to support a determination
that Steil teaches "the at least two subcutaneous electrodes being comprised
by the infusion cannula" as required by claims 1 and 12. Because they
depend from claim 1 or 12, the rejection of claims 2-8, 10, 11, and 13, is
also reversed.
II.
The Examiner has rejected claim 9 under 35 U.S.C. § 103(a) as being
obvious based on Steil, Polychronakos, and Ben-David. Because the
Examiner has pointed to no clear or specific teaching in Ben-David that
addresses the deficiencies discussed above of Steil and Polychronakos with
respect to claim 1, from which claim 9 depends, we reverse this rejection as
well.
III.
The Examiner has rejected claims 14 and 15 under 35 U.S.C. § 103(a)
as being obvious based on Steil, Polychronakos, and Ben-David. Because
the Examiner has pointed to no clear or specific teaching in Ben-David that
addresses the deficiencies discussed above of Steil and Polychronakos with
respect to claim 12, from which claims 14 and 15 depend, we reverse this
rejection as well.
5
Appeal2014-004352
Application 12/641,911
SUMMARY
We reverse the rejection of claims 1-8 and 10-13 under 35 U.S.C.
§ 103(a) based on Steil and Polychronakos.
We reverse the rejection of claim 9 under 35 U.S.C. § 103(a) based on
Steil, Polychronakos, and Ben-David.
We reverse the rejection of claims 14 and 15 under 35 U.S.C. § 103(a)
based on Steil, Polychronakos, and Ben-David.
REVERSED
6