Ex Parte Powers et al

Patent Trial and Appeal Board

Sep 29, 2014

11577370 (P.T.A.B. Sep. 29, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DANIEL J. POWERS, SHANNON FONG,
ERIC JONSEN, and PATRICK HAUGE1
__________

Appeal 2012-004550
Application 11/577,370
Technology Center 3700
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Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
enclosure for a medical instrument. The Examiner has rejected the claims as
anticipated and/or obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
Claims 3–22 are pending and on appeal (App. Br. 3). Claims 13 and
21 are illustrative and read as follows (emphasis added):

1 Appellants identify the real party in interest as Koninklijke Philips
Electronics N.V. (App. Br. 3).
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13. An electrode and enclosure for a medical monitoring or therapy
instrument comprising:
an enclosure formed of a substantially rigid, moisture impervious
material and having an inner surface against which one or more electrodes
may be sealed, the enclosure having an open state in which electrodes inside
the enclosure may be accessed and a closed state;
first and second electrodes each having a substantially moisture-
impervious outer layer, an electrically conductive gel layer, the outer layer
of each electrode being peripherally sealed to the inner surface of the
enclosure prior to use;
an electrical circuit disposed on the enclosure comprising first and
second mateable connectors which are in electrical contact with the gel
layer of each electrode when the electrodes are sealed to the inner surface of
the enclosure, the mateable connectors being open when the enclosure is in
its open state and the mateable connectors being mated when the enclosure
is in its closed state to electrically connect the gel layers of the electrodes;
and
a closing device which retains the enclosure in its closed state prior to
use of the electrodes,
wherein the electrode further comprises a metallic layer located
between the outer layer and the gel layer.
21. An enclosure for a pair of electrodes for use in a defibrillator
comprising:
a hinged enclosure, having an open state and a closed state, formed of
a substantially rigid, moisture impervious material;
first and second release surfaces formed on an inner surface of the
hinged enclosure;
first and second heat sealing surfaces disposed on an inner surface of
the hinged enclosure and about the periphery of the first and second release
surfaces;
first and second conductive elements disposed on the first and second
release surfaces;
first and second mateable connector ends disposed on the enclosure in
conductive contact with first and second conductive elements, the mateable
connector ends being mated when the enclosure is in the closed state; and
a closing device which retains the enclosure in the closed state.
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Claims 3–9, 13, and 14 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Scharnberg et al. (US 4,779,630, Oct. 25, 1988) (Supp.
Ans.2 3).
Claims 3, 5–14, and 16–20 stand rejected under 35 U.S.C. § 103(a) as
obvious over Picardo et al. (US 2002/0082644 A1, June 27, 2002) in view of
Lyster et al. (US 2003/0055478 A1, Mar. 20, 2003) and Stolte (US
5,697,955, Dec. 16, 1997) (Supp. Ans. 6).
Claim 15 stands rejected under 35 U.S.C. § 103(a) as obvious over
Picardo in view of Lyster, Stolte, and Nielsen et al. (US 2003/0130714 A1,
July 10, 2003) (Supp. Ans. 11).
Claims 21 and 22 stand rejected under 35 U.S.C. § 103(a) as obvious
over Picardo in view of Lyster, Stolte, and Bishay et al. (US 6,272,385 B1,
Aug. 7, 2001) (Supp. Ans. 11-12).
I
The Examiner finds that Scharnberg teaches a defibrillator pad
assembly having all of the features of claim 13 (id. at 3–4).
Analysis
Appellants argue that Scharnberg fails “to disclose any electrical
circuit connecting both electrode gel layers to each other” (App. Br. 10).
We agree.
The Examiner relies on the conductive polymer pad 16 for being the
gel layer of each electrode (Supp. Ans. 4). As noted by the Examiner (id.),
Scharnberg discloses: “As can be seen in FIG. 7, the conductive strip 26

2 “Supp. Ans.” refers to the supplemental Examiner’s Answer dated
October 13, 2011.
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provides electrical continuity from console electrode 36 to paddle
electrode 28 through the conductive strip 26 and the conductive polymer 16.
This permits the defibrillator paddles to be tested by manipulating the
controls of console 32.” (Scharnberg, col. 6, ll. 1–6). However, the
Examiner has not pointed to any teaching indicating that one circuit
electrically connects both of pads 16.
The Examiner responds that the claim does not recite that the
“electrical circuit connect[s] both electrode gel layers to each other”
(Ans.3 18). However, claim 13 requires a single electric circuit that, when
closed, electrically connects the gel layers. Thus, we agree with Appellants
that the claim requires the gel layers to be electrically connected to each
other when the enclosure is closed (App. Br. 10).
Conclusion
The Examiner has not set forth a prima facie case that Scharnberg
teaches each and every feature of claim 13. We therefore reverse the
anticipation rejection of claim 13 and of claims 3–9 and 14, which depend
directly or indirectly from claim 13.
II
In the first obviousness rejection, the Examiner relies on Picardo for
teaching a cartridge for storing an electrode pad having many of the features
of claim 13 (Supp. Ans. 6–7). However, the Examiner finds:
Picardo does not teach the electrical circuit being in contact
with a gel layer of the electrodes when the electrodes are sealed
to the inner surface of the enclosure or the electrical circuit
comprising mateable connectors which are in electrical contact

3 “Ans.” refers to the Examiner’s Answer dated August 5, 2011.
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with the gel layer of each electrode when the electrodes are
sealed to the inner surface of the enclosure.
(Id. at 7.)
The Examiner relies on Lyster for teaching
a medical electrode and release liner configuration facilitating
packaged electrode characterization in which electrodes are
mounted on halves of a mounting surface of a release liner that
contains a conductive strip (550, Figure 5; 650, Figure 6) that is
in contact with the gel layer of the electrodes for forming an
electrical circuit connecting the electrodes in order to test the
electrodes before use.
(Id.).
The Examiner relies on Stolte for teaching “an electrode package
containing a tear line (69, Fig. 3) which is in contact with an electrical
circuit that connects the two electrodes within the package that is broken
when the package is opened” (id.). In particular, the Examiner finds:
“When the package is closed an electrical circuit is completed between the
lead wires of the electrodes. When the package is opened the user tears
along tear line (69, Fig. 3), which breaks or tears connector (64, Fig. 3),
thereby opening the circuit between the lead wires.” (Id. at 7–8.) In
addition, the Examiner finds “that the electrical circuit may be used in order
to determine the freshness and status of a package of defibrillation
electrodes” (id. at 8).
The Examiner concludes:
It would have been obvious to one having ordinary skill in the
art at the time of the invention to modify the device of Picardo
with the teachings of Lyster to include forming an electrical
circuit by contacting the gel layer of each electrode with a
conductive element/strip on the inner surface of the enclosure in
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order to allow the electrodes to be connected for testing before
use of the device. Further, . . . Picardo discloses a sensor
disposed on the enclosure which is utilized in determining
whether the electrode packaging is open or closed, only
allowing testing of the electrodes to occur if the packaging
“enclosure” is closed. . . . It would have been obvious to one
having ordinary skill in the art at the time of the invention to
further modify the device of Picardo modified by Lyster with
the teachings of Stolte to include placing the sensor/connector
on the electrode package/enclosure in contact/communication
with the conductive strip of the electrical circuit in order to
determine the status of the package of defibrillation electrodes,
i.e. fresh electrodes in a ready state or in use, and allowing
testing of the electrodes by the electrical circuit if it is indicated
that the electrodes are unopened/ fresh electrodes in a ready
state.
(Id. at 8–9.)
Analysis
Appellants argue that “[n]one of Picardo, Lyster or Stolte discloses or
suggest the Claim 13 limitation of mateable connectors that are open when
the enclosure is open and which electrically connect the electrode gel layers
when the enclosure is closed” (App. Br. 13). We agree.
The Examiner does not rely on any of the applied references to teach
mateable connectors (Supp. Ans. 6–8). Instead, the Examiner finds:
The element(s), e.g. the tear strip in contact with the connector,
disclosed by Stolte are a substantial functional equivalent to the
mateable connectors as it provides the same function of
conducting electricity including being open when the enclosure
is in the open state and connecting the gel layers of the
electrodes when the enclosure is in the closed state, see MPEP
2183. The examiner notes that applicant has not placed any
criticality on the connectors being mateable, e.g. for resealing
purposes of the electrodes, as it appears that the electrodes
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would be for one time use, and it appears that any connector
which connects the gel layers when the enclosure is closed and
opens the connection when the enclosure is open would be
appropriate. Additionally, one of ordinary skill in the art would
have expected Stolte[’s] tear strip in contact [with] a connector
and applicant’s mateable connectors to perform equally well
because both would perform the same function of being open
when the enclosure is in the open state and connecting the gel
layers of the electrodes when the enclosure is in the closed
state.
(Id. at 8; see also Ans. 20–21.)
However, even if Appellants’ structure is a substantial functional
equivalent to Stolte’s structure, we do not agree that this is sufficient to
demonstrate that Appellants’ structure would have been obvious. Instead,
the Examiner needs to set forth a prima facie case that the applied art teaches
or suggests each and every feature of the claimed invention. That is,
evidence must be adduced, not simply argument. In addition, until the
Examiner has set forth a prima facie case, there is no need for Appellants to
show, for example, that their structure provides any criticality.
Conclusion
The Examiner has not set forth a prima facie case that Picardo, Lyster,
and Stolte suggest the device of claim 13. We therefore reverse the
obviousness rejection of claim 13 and of claims 3, 5–12, 14, and 16–20,
which depend directly or indirectly from claim 13.
III
In rejecting claim 15, which depends from claim 13, the Examiner
additionally relies on Nielsen (Supp. Ans. 11). However, the Examiner does
not adequately explain how Nielsen overcomes the deficiency in Picardo,
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Lyster, and Stolte discussed above (id.). Thus, the Examiner has not set
forth a prima facie case that Picardo, Lyster, Stolte, and Nielsen suggest the
device of claim 15. We therefore reverse the obviousness rejection of
claim 15.
IV
In rejecting claim 21, the Examiner relies on Picardo, Lyster, and
Stolte substantially as discussed above (id. at 12–14). In addition, the
Examiner relies on Bishay for disclosing “the technique of heat sealing an
electrode in order to prevent desiccation of the electrolytic gel within the
defibrillator electrode” (id. at 14). The Examiner concludes that it would
have been obvious “to modify the enclosure of Picardo modified by Lyster
and Stolte to include heat sealing surfaces in order to allow the electrode to
be heat sealed to the release surfaces in order to prevent desiccation of the
electrolytic gel within the defibrillator electrode” (id.).
Analysis
Appellants argue that “none of Picardo, Lyster, Stolte or Bishay
discloses the mateable connector limitations of Claim 21” (App. Br. 15).
For substantially the reasons discussed above, we agree with Appellants that
the Examiner has not set forth a prima facie case that Picardo, Lyster, and
Stolte suggest the mateable connectors. In addition, the Examiner does not
rely on Bishay to overcome this deficiency (Supp. Ans. 14).
Conclusion
The Examiner has not set forth a prima facie case that Picardo, Lyster,
Stolte, and Bishay suggest the device of claim 21. We therefore reverse the
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obviousness rejection of claim 21 and of claim 22, which depends from
claim 21.

REVERSED

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