Ex Parte Pianca et al

Board of Patent Appeals and Interferences

May 23, 2012

10503281 (B.P.A.I. May. 23, 2012)

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.
10/503,281 03/11/2005 Anne M. Pianca 1362009-2060 5714
50638 7590 05/23/2012
Boston Scientific Neuromodulation Corp.
c/o Frommer Lawrence & Haug LLP
745 Fifth Ave
NEW YORK, NY 10151
EXAMINER
FLORY, CHRISTOPHER A
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
05/23/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte ANNE M. PIANCA, TODD K. WHITEHURST, and
JAMES P. McGIVERN
____________________

Appeal 2010-000913
Application 10/503,281
Technology Center 3700
____________________

Before JOHN C. KERINS, EDWARD A. BROWN, and
WILLIAM V. SAINDON, Administrative Patent Judges.

BROWN, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2010-000913
Application 10/503,281

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STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the rejection of
claims 1, 3-5, 7, 9-11, and 22-32. (App. Br. 2). Claims 2, 6, 8, and 12-21
have been cancelled. (Id.). We have jurisdiction over this appeal under 35
U.S.C. § 6(b).
We REVERSE.

THE INVENTION
The invention is directed to a lead assembly for small, implantable
medical devices. (Spec. para. [0001]). Independent claim 1, reproduced
below with emphasis added, is representative of the appealed claims.
1. A lead assembly for attachment to a small,
implantable leadless medical device including a
distal device electrode and a proximal device
electrode disposed on opposing ends of the
medical device, the lead assembly comprising:
an insulated lead including a proximal end
and a distal end, with at least one conductor
therebetween;
at least one electrode at the distal end of the
lead and electrically connected to the at least one
conductor; and
a connector attached to the proximal end of
the lead and adapted to be removably connectable
to, and substantially entirely cover, the distal
device electrode of the medical device,
wherein the connector includes at least one
contact to electrically connect the distal device
electrode to the at least one conductor, wherein the
lead assembly comprises a closure as part of the
connector, wherein the closure inhibits fluid
ingress into a portion of the connector that
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receives the distal device electrode, the closure
collapsing and sealing when the distal device
electrode of the medical device is not present in
the connector.

THE REJECTIONS
The following rejections are before us for review:
1. Claims 1, 3, 4, 7, 9-11, 22-27, 29, 31, and 32 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Dahl (US 2002/0111663 A1,
pub. Aug. 15, 2002), Hoffmann (US 5,000,177, iss. Mar. 19, 1991), and
Hawkins (US 5,730,628, iss. Mar. 24, 1998).
2. Claims 5 and 30 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Dahl, Hoffmann, Hawkins, and Bronikowski (US
4,456,942, iss. Jun. 26, 1984).

ANALYSIS
Claims 1, 3, 4, 7, 9-11, 22-27, 29, 31, and 32
Regarding claim 1, the Examiner found Dahl discloses a lead
assembly for an implantable medical device, comprising an insulated lead 10
with conductors 21, 23, 25; a distal electrode 12; and a connector (connector
140 and pins 142, 146). (Ans. 5, citing Figs. 5 and 11). The Examiner
found that the electrical contacts within the mating interface 160 of Dahl are
electrodes, and that the connector covers the device electrode when engaged.
(Ans. 5). The Examiner also found Dahl discloses a closure (roll-back
sleeve 250) (Ans. 12; see Dahl para. [0063]; Figs. 10-11), but does not
disclose that the closure is part of the connector (Ans. 7). Figures 10 and 11
of Dahl show the sleeve 250 disposed on the mating interface 160. The
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Application 10/503,281

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Examiner determined that it would have been obvious to one of ordinary
skill in the art to put the closure on the connector in Dahl, as a routine
rearrangement of parts. (Ans. 7).
The Examiner found Dahl does not disclose that the closure collapses
and seals when an implantable medical device is not present in the
connector. (Ans. 6). The Examiner found Hoffmann discloses a self-sealing
lead adapter seal member (i.e., connector) which functions as an elastic
resilient member with an elastically deformable opening that admits an
insertion tool and closes the passageway upon its withdrawal. (Id., citing
Hoffmann col. 3, l. 60 – col. 4, l. 9). The Examiner determined that it would
have been obvious to one of ordinary skill in the art to modify Dahl with the
self-sealing closure system taught by Hoffmann to inhibit fluid ingress into
the adapter opening by sealing the passageway when the intended tool is not
connected. (Id.).
Appellants correctly point out that Hoffmann does not teach a closure
of a connector that inhibits fluid ingress into a portion of the connector that
receives a distal device electrode, or that collapses and seals when the distal
device electrode is not present in the connector. (App. Br. 9-10; Reply Br.
6-10). Hoffmann discloses a lead adapter 16 including a body 26 with a
barrel 42 which receives a lead 18, and connector assemblies 48, 50.
(Hoffmann col. 4, l. 51 – col. 5, l. 1 & col. 5, ll. 30-36; Fig. 1). The
connector assemblies 48, 50 include cylindrical plug seals 64, 72 having
passages 68, 78 for admitting a tool. (Hoffmann col. 5, l. 55 – col. 6, l. 20).
Hoffmann discloses that the passage 68 (and also passage 78) closes (when
the tool is withdrawn) to provide fluid isolation. (Hoffmann col. 6, ll. 1-9).
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Application 10/503,281

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Hoffmann does not disclose that a device electrode is inserted into the
connector assemblies 48, 50.
The Examiner does not adequately explain how Dahl's lead including
connector 140 would be modified with the closure system taught by
Hoffmann. If Dahl's device were modified by placing the roll-back sleeve
250 on the connector 140 instead of on the mating interface 160, the sleeve
250 would be rolled-back on the connector 140 as shown in Figures 10 and
11 for the mating interface 160, to allow the connector 140 to be connected
to the mating interface 160. The roll-back sleeve 250 would not collapse to
inhibit the ingress of fluid when in its un-rolled condition (Figure 10) in
which the connector 140 and mating interface 160 are not connected to each
other, but the sleeve 250 is configured to allow it to be rolled-back.
Hoffmann's cylindrical plug seal 64 (or plug seal 72) is generally solid and
configured to be inserted into a bore. It is not apparent to us how the
structure of Hoffmann's cylindrical plug seal 64 having passage 68 would be
used for modifying Dahl's connector 140 having outwardly-extending
connecting pins 142, 146 which would appear to be covered by placing the
plug seal 64 on the connector 140, or for modifying the roll-back sleeve 250,
which is hollow and configured to receive the entire connector 140.
In response to Appellants' contentions, the Examiner stated:
[W]hat is lacking from Dahl is not the structure of
a connector or even the structure of a closure
means, but that the closure structure already
clearly shown expressly discloses inhibition of
fluid ingress. Figure 10 already suggests that the
closure structure would inherently provide some
inhibition of fluid ingress. Thus, Hoffmann is
applied not for the sake of teaching the closure
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structure itself, but that the closure structure should
allow insertion and removal of a desired medical
tool and upon withdrawal provide inhibition of
fluid ingress for the cited motivations. As such,
the proper combination of Dahl and Hoffmann
clearly arrives at the argued limitation.
(Ans. 12) (emphasis added). The Examiner stated that Hoffmann is not
applied for teaching the closure structure itself. We agree that the Examiner
that Dahl's closure 250 would inhibit fluid ingress if it were applied on the
connector 140, when the connector 140 is connected to the mating interface
160. In this regard, Dahl discloses that "[t]his sleeve . . . is rolled over the
proximal end of a lead such as a lead shown in FIG. 5. This forms a
hermetic seal that prevents fluid ingress around the connector pins of
connector 140 and the ports of mating interface 160." (Dahl para. [0063]).
However, Dahl's closure structure does not collapse and seal when a distal
device electrode is not present in the connector. As such, Dahl does not
disclose a closure structure that meets each of the limitations of the closure
called for by claim 1. As discussed supra, the Examiner has not articulated
an adequate explanation as to how Hoffmann would be combined with Dahl
to result in the combination comprising the closure as recited in claim 1.
Accordingly, we do not sustain the rejection of claim 1, and claims 3, 4, 7,
and 9-11 which depend from claim 1.
The Examiner relied on Hawkins for disclosure in regard to the
springs called for by claim 22 and claims 23-26, and for features of claims
27 and 28. (Ans. 8-9). However, the Examiner's application of Hawkins
does not cure the deficiencies of Dahl and Hoffmann with respect to claim 1
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as discussed supra. Hence, we also do not sustain the rejection of claims 22-
28.
Independent claim 29 is directed to a lead assembly comprising a
connector and a closure as part of the connector and which comprises "a
pouch of biocompatible elastic material configured and arranged to prevent
fluid ingress into a portion of the pouch that receives the distal device
electrode by collapsing and sealing when the distal device electrode of the
medical device is not present in the connector." We also do not sustain the
rejection of claim 29 for reasons similar to those discussed supra in regard to
claim 1. We also do not sustain the rejection of claim 31 which depends
from claim 29.
Independent claim 32 is directed to a lead assembly and recites "the
connector comprises at least one contact . . . configured with edges that
extend at least partly around the distal electrode when the medical device is
inserted into the connector and which aids the closure in inhibiting fluid
ingress into the connector when the medical device is not present in the
connector," and "a closure as part of the connector, the closure comprising a
pouch of biocompatible elastic material configured to seal the closure when
the medical device is not present in the connector." (Emphasis added). We
also do not sustain the rejection of claim 32 for reasons similar to those
discussed supra.

Claims 5 and 30
Claims 5 and 30 depend from claims 1 and 29, respectively. The
Examiner relied on Bronikowski for features of the edges of the contact
recited in claims 5 and 30. However, the Examiner's application of
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Bronikowski does not cure the deficiencies of Dahl and Hoffmann with
respect to the rejection of claims 1 and 29, as discussed supra. Hence, we
also do not sustain the rejection of claims 5 and 30.

DECISION
The rejection of claims 1, 3-5, 7, 9-11, and 22-32 is REVERSED.

REVERSED

mls