Ex Parte Wilkowske et al

Board of Patent Appeals and Interferences

Mar 2, 2012

11033098 (B.P.A.I. Mar. 2, 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.
11/033,098 01/10/2005 Eric John Wilkowske 0B-046600US-82410.0194 8061
55962 7590 03/05/2012
SJM/AFD-WILEY
Legal Department
One St. Jude Medical Drive
St. Paul, MN 55117-9913
EXAMINER
SMITH, FANGEMONIQUE A
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
03/05/2012 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 ERIC JOHN WILKOWSKE, ALLAN MANUEL FUENTES,
XIAOPING GUO, XUAN YEN KHIEU, LINDA KAY NEMEC,
and RICHARD E. STEHR
__________

Appeal 2010-008012
Application 11/033,098
Technology Center 3700
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and FRANCISCO C.
PRATS, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of making a flexible tubular body for, e.g., a catheter. The Examiner has
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
Appeal 2010-008012
Application 11/033,098

2
STATEMENT OF THE CASE
The Specification discloses that deflection wires are used to deflect
the distal tip of steerable catheters and that, in the prior art, the deflection
wires are embedded in thermoplastic material (Spec. 1:13-19). The
Specification discloses that the embedding process “allows the deflection
wires to create their own wire lumens … approximately equal in diameter”
with the wires, which causes problems in subsequent use of the catheters (id.
at 1:20 to 2:5).
The Specification discloses making a flexible tubular body by “pre-
extruding an inner layer of the body from a thermoplastic polymer.… If wire
lumens were not integrally formed in the inner layer when pre-extruded,
then two polymer spaghetti tubes, each with wire lumens, are laid … along
the outer surface of the inner layer. Deflection wires are then fed into the
wire lumens” (id. at 2:23-29). The Specification discloses that a
“pressurized fluid is injected into each wire lumen to maintain the internal
diameter of each wire lumen at a diameter that is greater than the diameter of
the deflection wire” when heat is applied to melt an outer polymer layer (id.
at 3:1-3).
Claims 1-25 and 36-42 are on appeal. Claims 1, 40, and 42 are
representative and read as follows:
1. A method of manufacturing a flexible tubular body for a catheter
or sheath, the flexible tubular body comprising a melt-processable polymer,
the method comprising:
forming a wire lumen;
placing a deflection wire in the wire lumen;
injecting a fluid into the wire lumen; and
melt-processing the flexible tubular body while the fluid and the
deflection wire are in the wire lumen.
Appeal 2010-008012
Application 11/033,098

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40. A method of manufacturing a catheter having flexible tubular
body, the method comprising:
forming a lumen having an inner diameter large enough to accept a
deflection wire therethrough;
inserting a deflection wire into the lumen;
pressurizing the lumen to a pressure sufficient to resist collapse of the
wire lumen during lamination of the flexible tubular body via heating;
applying a layer of shrink-wrap about the flexible tubular body to
exert pressure on and prevent expansion of the flexible tubular body during
heating thereof; and
heating the flexible tubular body while the lumen is pressurized and
contains the deflection wire.

42. A method of manufacturing a flexible tubular body for a
catheter or sheath, the flexible tubular body comprising a melt-
processable polymer, the method comprising:
providing an inner layer;
applying an outer layer about the inner layer;
forming a wire lumen in at least one of the inner layer and the
outer layer adjacent an interface between the inner layer and the outer
layer;
injecting a fluid into the wire lumen; and
melt-processing the flexible tubular body to bond the inner
layer and the outer layer together while the fluid is in the wire lumen.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 1-4, 6, 7, 10-12, 21-25, and 36-42 in view of Imran,
1

Johansen,
2
Saab,
3
and Pursley;
4

1
Imran et al., US 5,662,608, issued Sept. 2, 1997.
2
Johansen et al., US 6,951,554 B2, issued Oct. 4, 2005.
3
Saab, US 5,342,301, issued Aug. 30, 1994.
4
Pursley, US 6,030,371, issued Feb. 29, 2000.
Appeal 2010-008012
Application 11/033,098

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• Claims 5, 9, and 13-20 in view of Imran, Johansen, Saab, Pursley
and Chouinard;
5
and
• Claim 8 in view of Imran, Johansen, Saab, Pursley and Reiss.
6

Each of the Examiner‟s rejections relies on the combination of Imran,
Johansen, Saab, and Pursley. The Examiner finds that Imran discloses a
method of manufacturing a catheter which “comprises forming a lumen,
injecting a fluid into the lumen and heating and tensioning the flexible
tubular body while the fluid is in the lumen…. Imran et al. further disclose
having a deflection wire (56) located in the lumen when the liquid fluid is
being injected” (Answer 3). The Examiner finds that Johansen discloses
forming a wire lumen by heat shrinking material around a mandrel (id.).
The Examiner finds that Saab discloses “making multi-lumen balloons
and catheters … by heat shrinking a thermoplastic film or thin-walled tubing
over one or more forming wires or mandrels … [and] suggests the support
mandrel be replaced with a pressurized fluid for support” (id. at 4). The
Examiner finds that Pursley discloses a method of making catheters which
includes placing a deflection wire “within a passageway of the catheter
while the catheter is being fabricated” (id. at 5).
The Examiner concludes that it would have been obvious to apply
Imran‟s “method of manufacturing a lumen for a catheter or sheath … to
form a wire lumen … [as] disclosed by Johansen et al., to gain a smooth
passageway, while providing different materials to strengthen the lumen”
(id. at 4). The Examiner also concludes that it would have been obvious to

5
Chouinard, US 6,709,455 B1, issued Mar. 23, 2004.
6
Reiss, US 6,913,617 B1, issued July 5, 2005.
Appeal 2010-008012
Application 11/033,098

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use “a pressurized lumen during the heat-shrinking process … [as] disclosed
by Saab, to provide additional methods of forming the tubular body” (id. at
5). The Examiner further concludes that it would have been obvious to
“include a deflection wire in the catheter as the catheter is being formed …
[as] disclosed by Pursley, to secure the deflection mechanism into the
device” (id.).
Appellants contend that “none of the cited references teach or suggest
melt processing a flexible tubular body having a wire lumen that contains
both a fluid and a deflection wire as recited in claims 1 and 40” (Appeal Br.
5).
We agree with Appellants that the Examiner has not adequately
explained how the cited references would have made obvious the methods of
claims 1 and 40. Claim 1 requires “placing a deflection wire in the wire
lumen; injecting a fluid into the wire lumen,” and heat processing the
flexible tubular body while the fluid and wire are in the wire lumen.
Similarly, claim 40 requires “inserting a deflection wire into the [wire]
lumen; pressurizing the lumen,” and heating processing the flexible tubular
body while the wire-containing lumen is pressurized.
The Examiner cites references to show that pressurized fluid or wires
or mandrels can be used to shape lumens during heating. However, the
Examiner has not pointed to anything in the references that would have
made obvious the use of both a wire and pressurized fluid in the same lumen
at the same time to shape the lumen during heating. The Examiner states
that Imran discloses “having a deflection wire (56) located in the lumen
when the liquid fluid is being injected” (Answer 3, citing Imran at col. 4,
Appeal 2010-008012
Application 11/033,098

6
ll. 22-60). The cited passage of Imran, however, is discussing a method of
using, not making, a balloon catheter.
The Examiner therefore has not adequately explained how the cited
references would have made obvious heat-processing flexible tubular bodies
comprising wire lumens that contain both a wire and an injected fluid (as
required by claim 1) or that contain a wire and are pressurized (as required
by claim 40). Thus we reverse the rejection of claims 1 and 40 and
dependent claims 2-25 and 41.
Claim 36 is directed to a method of manufacturing a flexible tubular
body for a catheter or sheath that comprises, among other steps, “forming a
wire lumen…; placing a deflection wire in the wire lumen; and injecting a
fluid into the wire lumen with the deflection wire in the wire lumen”. For
the reasons discussed above, we conclude that the Examiner has not
adequately explained how the cited references would have made obvious a
method of manufacturing a flexible tubular body that comprises both placing
a wire into a wire lumen and injecting a fluid into the wire lumen. Thus, we
reverse the rejection of independent claim 36 and dependent claims 37-39.
With regard to claim 42, Appellants argue that the cited references
would not have made obvious “a wire lumen „in at least one of the inner
layer and the outer layer adjacent an interface between the inner layer and
the outer layer,‟” as required by that claim (Appeal Br. 11). Appellants
argue, among other things, that “Pursley teaches that tube 110 is embedded
within the catheter wall as the catheter is formed.… Thus, it is not positioned
„adjacent an interface between the inner layer and the outer layer‟” (id. at
12).
Appeal 2010-008012
Application 11/033,098

7
We agree with Appellants that the Examiner has not adequately
explained how the cited references would have made obvious the method of
claim 42. As argued by Appellants, although Pursley discloses the
formation of a wire lumen by embedding a polyimide tube in the outer layer
of a flexible tubular body, the wire lumen is positioned within the outer
layer, rather than being adjacent to the inner layer (see Pursley, col. 9, ll.
1-10).
The Examiner therefore has not established a prima facie case of
obviousness with respect to any of the independent claims on appeal based
on Imran, Johansen, Saab, and Pursley. The Examiner cites Chouinard and
Reiss only with respect to limitations of dependent claims (see Answer 6-7);
these references therefore do not make up for the deficiency discussed
above.
SUMMARY
We reverse the rejection of claims 1-25 and 36-42 under 35 U.S.C.
§ 103(a).

REVERSED

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