Ex Parte Oslund et al

Board of Patent Appeals and Interferences

May 21, 2012

10100686 (B.P.A.I. May. 21, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
10/100,686 03/14/2002 John C. Oslund EV31016US 5297
14018 7590 05/21/2012
Covidien
Attn: IP Legal Department
15 Hampshire Street, Bldg. 4A
Mansfield, MA 02048
EXAMINER
TOWA, RENE T
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
05/21/2012 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 JOHN C. OSLUND
and PATRICK P. RUSSO
__________

Appeal 2011-001074
Application 10/100,686
Technology Center 3700
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to catheter
and guidewire assemblies. The Examiner has rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
“Two types of wire/catheter configurations are commonly employed:
an ‘over-the-wire’ configuration and a ‘rapid-exchange’ configuration”
(Spec. 3:9-11). The Specification states that “over-the-wire” guidewires
Appeal 2011-001074
Application 10/100,686

2
typically are over 300 cm long (id. at 3:1-8) while “rapid-exchange”
guidewires typically are about 175 cm long (id. at 4:2-7). The Specification
states that it would be “beneficial to have an over-the-wire length guidewire
or hostwire that can be transformed into a guidewire or hostwire capable of
use in a rapid-exchange configuration” (id. at 5:8-13).
The Specification discloses an elongate wire that “has a length
appropriate for use with the corresponding over-the-wire configured
catheter. The wire is provided with a defined location of frangibility.” (Id.
at 6:11-13.) “[W]hen the wire is fractured at the defined location of
frangibility, the wire assumes a length appropriate for use with a
corresponding rapid-exchange catheter” (id. at 6:13-18).
Claims 30-39 and 53-62 are on appeal. Claim 30 is representative and
reads as follows:
30. An assembly for use by an operator in performing a medical
procedure in a lumen of a patient comprising an over-the-wire configured
catheter and a wire for use in deploying the over-the-wire configured
catheter, the wire comprising:
an elongate cylindrical body having a distal end, a proximal end and a
location of fracturability, the elongate cylindrical body being formed from a
single continuous piece of material having a cross-sectional shape defined
by the intersection of the elongate cylindrical body with a plane
perpendicular to an axis of the elongate cylindrical body, the cross-sectional
shape being substantially constant between the proximal end and the
location of fracturability and between the distal end and the location of
fracturability;
a full length of the elongate cylindrical body defined from the distal
end to the proximal end, a partial length of the elongate cylindrical body
defined from the distal end to the location of fracturability, the elongate
cylindrical body being configured to fracture outside of the lumen at the
location of fracturability upon application by the operator to the elongate
cylindrical body of a sufficient amount of bending stress, the sufficient
Appeal 2011-001074
Application 10/100,686

3
amount of bending stress being selected to be greater than a maximum
bending stress to which the elongate cylindrical body is subjected during the
medical procedure within the lumen, and less than an amount of bending
stress required to fracture the elongate cylindrical body at portions of the
elongate cylindrical body proximally and distally adjacent to the location of
fracturability;
wherein the partial length of the elongate cylindrical body is within a
range of between 160 centimeters and 200 centimeters.

The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 103(a) as being obvious in view of Ales,1 Sasamine,2 and Camps,3 either
by themselves or combined with an additional reference (Answer 3-8). The
same issue is dispositive for all of the rejections.
The Examiner finds that Ales discloses “an over-the-wire configured
catheter and a wire … comprising: an elongate cylindrical body … and a
location of fracturability” (Answer 3-4). The Examiner finds that Ales’ wire
is “configured to fracture outside of the lumen at the location of
fracturability 16 upon application … of bending stress” (id. at 4). The
Examiner finds that Ales “fails to explicitly disclose that the partial length of
the elongate body is within a range of between 160-200 cm” (id.).
The Examiner finds that Sasamine discloses “an extendable guidewire
having a partial length of between about 175-195 cm” (id.), and concludes
that this would have been an obvious length for Ales’ wire since it is an
appropriate length “for guiding a cardiovascular catheter” (id. at 5). The
Examiner finds that Camps discloses “an elongate cylindrical body 6 having

1 Ales et al., US 5,441,055, issued Aug. 15, 1995.
2 Sasamine et al., US 5,701,911, issued Dec. 30, 1997.
3 Camps et al., US 5,241,957, issued Sept. 7, 1993.
Appeal 2011-001074
Application 10/100,686

4
… a location of fracturability 14 …; wherein said location of fracturability
14 is defined by an axially concave recess” (id. at 4-5). The Examiner
concludes that it would have been obvious to provide Ales’ guidewire with a
“one-piece elongated cylindrical body with a location for breaking the …
body as taught by Camps et al. in order to achieve a guidewire-extension
wire assembly that avoids the risk associated with detachment of the
guidewire parts while permitting the guidewire to break under the
application of a predetermined force” (id. at 6).
Appellants argue that it would not have been obvious to modify Ales’
guidewire to be an “elongate cylindrical body being formed from a single
continuous piece of material having a cross-sectional shape … substantially
constant between the proximal end and the location of fracturability and
between the distal end and the location of fracturability,” as required by the
claims (Appeal Br. 9-12). Appellants argue that Ales’ guidewire is not
formed of a single continuous piece of material but “is comprised of
multiple discontinuous portions connected by sleeves” (id. at 7) because “the
object is to start out with a short length of wire which can be lengthened
during use in order to permit catheter exchanges” (id. at 8). Appellants
argue that modifying Ales’ assembly as proposed by the Examiner would
eliminate the advantages disclosed by Ales (id. at 10).
We agree with Appellants that the Examiner has not adequately
explained how the cited references would have made obvious the wire of
claim 30. Ales discloses a “guidewire extension wire and connector
assembly for connecting to a proximal end of an initially inserted guidewire”
(Ales, col. 1, ll. 7-9). Figures 1 and 2 of Ales are shown below.
App
App

Figu
dista
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and t
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Ales dis
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4, 43-45).
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“When th
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neck 42
sion 20 at
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sleeve 44
01074
/100,686
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Ales discl
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“with the
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the “junct
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oses that w
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ixing mec
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the distal
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l. 5, ll. 7-1
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an initially
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l. 3, ll. 48
guidewire
(id. at co
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4). The g
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57).
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[12], a
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. 4, ll. 58-
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0 and
similar in

Appeal 2011-001074
Application 10/100,686

6
size to initial stub end 10, so that the extension process can be repeated later
if necessary (see id. at col. 5, ll. 20-33).
Claim 30 requires a “wire comprising: an elongate cylindrical body …
formed from a single continuous piece of material” (claim 30). As discussed
above, Ales discloses a three-piece wire assembly that includes the
guidewire, a connection assembly, and a guidewire extension, for extending
the initially inserted guidewire. The Examiner has not provided adequate
evidence or sound technical reasoning to support the conclusion that it
would have been obvious to modify Ales’ device to include a cylindrical
body formed from a single piece of material, when doing so would appear to
defeat Ales’ purpose of allowing an initially inserted guidewire to be
repeatedly extended.
And, even if one of ordinary skill were motivated to form the wire of
Ales’ three-piece device as a unitary piece with an integral location of
fracturability, the wire would still not appear to have “a cross-sectional
shape … substantially constant between the proximal end and the location of
fracturability and between the distal end and the location of fracturability,”
as required by claim 30. As can be seen in Figures 1 and 2 of Ales, none of
the guide wire (12), the wire portion of the connector assembly (34), or the
guidewire extension (20) have substantially constant cross-sections. Thus,
we reverse the rejection of independent claim 30 and dependent claims 31-
34 and 36-37.
Independent claim 53 requires the same wire as claim 30. Thus, we
also reverse the rejection of claim 53 and dependent claims 54-57 and 59-60.
Appeal 2011-001074
Application 10/100,686

7
We also reverse the rejections of claims 35, 38, 39, 58, 61, and 62
under 35 U.S.C. § 103(a) because these rejections rely on the findings with
respect to Ales, Sasamine, and Camps as discussed above, and the Examiner
relies on the other cited references (Answer 7-8) only to show the
obviousness of limitations in dependent claims.
SUMMARY
We reverse the rejection of claims 30-39 and 53-62 under 35 U.S.C.
§ 103(a).

REVERSED

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