Ex Parte McFerran

Patent Trial and Appeal Board

Jun 18, 2013

10667056 (P.T.A.B. Jun. 18, 2013)

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.
10/667,056 09/22/2003 Sean McFerran 1001.1708101 7830
11050 7590 06/19/2013
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
GRAY, PHILLIP A
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
06/19/2013 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SEAN McFERRAN
__________

Appeal 2012-000565
Application 10/667,056
Technology Center 3700
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal
1
under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 13, 15-17, and 21-28.
2
We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.

1
The Real Party in Interest is Boston Scientific Scimed, Inc. (App. Br. 3).
2
Claims 18-20 are also pending, and have been indicated as being allowable
(App. Br. 3; see also Ans. 3).
Appeal 2012-000565
Application 10/667,056

2
STATEMENT OF THE CASE
Claim 13 is representative of the claims on appeal, and reads as
follows (emphasis added):
13. A single lumen microcatheter, comprising:
an elongate shaft having a distal end and a proximal end, the elongate
shaft having an outer surface and an inner surface, the inner surface defining
a single lumen extending from the proximal end to the distal end of the
elongate shaft and fluidly connecting the proximal end to an opening at the
distal end of the elongate shaft;
an elongate guidewire port positioned proximal of the distal end of the
elongate shaft, the elongate guidewire port extending from the inner surface
of the elongate shaft to the outer surface of the elongate shaft; and
a polymer sheath disposed over the elongate guidewire port, the
polymer sheath having an inner surface and an outer surface, the polymer
sheath having a length measured from a proximal end of the polymer sheath
to a distal end of the polymer sheath, the polymer sheath including a passage
comprising an angled slit extending radially through the polymer sheath at
an angle such that the slit has a depth that is greater than a thickness of the
polymer sheath, the slit disposed parallel to a longitudinal axis of the
elongate shaft, the slit having a length measured parallel to the length of the
polymer sheath and parallel to the longitudinal axis of the elongate shaft, the
length of the slit being less than the length of the polymer sheath such that
the slit extends along only a portion of the length of the polymer sheath, the
passage in communication with the elongate guidewire port, wherein the
passage is configured to permit guidewire access through the elongate
guidewire port while remaining substantially fluid tight in use when no
guidewire is provided through the passage; and
wherein when no guidewire is provided through the passage, the
single lumen is substantially fluid tight from the proximal end of the
elongate shaft to the opening at the distal end of the elongate shaft.

Appeal 2012-000565
Application 10/667,056

3
The following ground of rejection is before us for review:
Claims 13, 15-17, and 21-28 stand rejected under 35 U.S.C. § 103(a)
as being rendered obvious by the combination of Pfenninger
3
and Allman.
4

ISSUE
Does the preponderance of the evidence support the Examiner’s
conclusion that the combination of Pfenninger and Allman renders obvious
the claimed microcatheter, wherein the polymer sheath that has a passage in
communication with a guidewire port is configured to permit guidewire
access through the elongate guidewire port while remaining substantially
fluid tight in use or when no guidewire is provided through the passage?

FINDINGS OF FACT
FF1. The invention is drawn to “catheters for delivery of therapeutic agents
or devices to a site within a body lumen” (Spec. 1).
FF2. Figure 7 of the Specification is reproduced below:

3
Pfenninger, US 5,306,247, issued Apr. 26, 1994.
4
Allman et al., US 6,346,093 B1, issued Feb. 12, 2002.
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Application 10/667,056

4

Figure 7 shows a cross-sectional view of a microcatheter as taught by the
Specification (id. at 4).
FF3. As shown in the Figure, the catheter contains a lumen 30 formed of a
polymer layer 28 (id. at 5). Guidewire port 46 has sides that taper inward,
facilitating entry of the guidewire (id. at 8).
FF4. Polymer sheath 50 is also shown in the Figure (id.), and includes a
control valve 56 that is configured to allow access to the guidewire port 46
(id. at 9). The control valve can include an elongate slit, which extends from
the outer surface 60 of the polymer sheath 50 to the inner surface 62 (id. at
10).
FF5. According to the Specification:
If the slit 58 is formed at an angle other than
perpendicular to the outer surface 60 of the polymer sheath 50,
the slit 58 will have a depth D3 that is greater than a thickness
D4 of the polymer sheath 50. As a result, adjacent portions of
the polymer sheath 50 (on either side of the slit 58) that contact
each other when nothing is passed through the control valve
will have increased surface area. In some embodiments, this
Appeal 2012-000565
Application 10/667,056

5
can result in greater sealing and can provide greater resistance
to inadvertently opening the slit 58 when not desired. Fluid
passed through the lumen can add pressure that assists in
sealing the valve.

(Id. at 9-10.)
FF6. The Examiner finds that “Pfenninger discloses the claimed invention
except for the longitudinal angled slit configured to permit guidewire access
through the guidewire port while maintaining a substantially fluid tight in
use when no guide wire is provided” (Ans. 7).
FF7. According to the Examiner:
Allman teaches that it is known to use a longitudinal angled slit
configured to permit guidewire access through the guidewire
port while maintaining a substantially fluid tight in use when no
guide wire is provided as set forth in paragraphs at column 8
lines 1-46 also see slit 118 in figure 4 and 4b or near 134 in
figure 4c to provide and allow a guidewire to be radially slid
into or out of the sheath assembly.
(Id.)
FF8. Allman is drawn to catheter for use with guidewires and endoscopes
(Allman, col. 1, ll. 25-28).
FF9. Figures 4B and 4C of Allman are reproduced below.
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Application 10/667,056

6

Figure 4B is a perspective view of an encircled sheath section having a slit,
and Figure 4C shows an alternative embodiment to that shown in Figure 4B,
wherein the sheath section has an overlap (id. at col. 3, ll. 48-52).
FF As shown in the Figure 4B, “[s]heath slit 118 is in communication
with hub slits 126 and 128, allowing a guidewire … to be radially slid into
or out of sheath assembly 110” (id. at col. 8, ll. 10-16). As taught by
Alllman, the slit 118 extends longitudinally over the length of the sheath
assembly (see id. at Fig. 4, not shown), terminating at the distal end (id. at
col. 8, ll. 1-6).
FF10. As shown in Figure 4C, “a sheath wall opening 134 and a sheath wall
overlap 136” allows a guidewire “to be slid out of lumen 132 of sheath 130
by maneuvering the guidewire into sheath wall opening 134 and through
overlap 136” (id. at col. 8, ll. 24-30).

Appeal 2012-000565
Application 10/667,056

7
ANALYSIS
Appellant argues that Allman does not appear to teach that the slit 118
is substantially fluid tight (Reply Br. 3).
We agree with Appellant. While the slit 118 or the overlap 136 of the
sheath of Allman allow a guidewire to be slid in and out of the lumen of the
sheath assembly, the Examiner has not pointed to any teaching in Allman or
provided any explanation as to why the ordinary artisan would consider the
slit or overlap of Allman, which extends longitudinally over the length of the
sheath assembly, to be fluid tight. As “obviousness requires a suggestion of
all limitations in a claim,” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d
1333, 1342 (Fed. Cir. 2003), we reverse the rejection.

CONCLUSION OF LAW
We conclude that the preponderance of the evidence does not support
the Examiner’s conclusion that the combination of Pfenninger and Allman
renders obvious the claimed microcatheter, wherein the polymer sheath that
has a passage in communication with a guidewire port is configured to
permit guidewire access through the elongate guidewire port while
remaining substantially fluid tight in use when no guidewire is provided
through the passage.
We thus reverse the rejection of claims 13, 15-17, and 21-28 under 35
U.S.C. § 103(a) as being rendered obvious by the combination of Pfenninger
and Allman.

REVERSED
dm