Ex Parte Weber et al

Patent Trial and Appeal Board

Mar 26, 2013

11068330 (P.T.A.B. Mar. 26, 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.
11/068,330 02/28/2005 Jan Weber 1001.2269101 2161
28075 7590 03/26/2013
SEAGER, TUFTE & WICKHEM, LLC
1221 NICOLLET AVENUE
SUITE 800
MINNEAPOLIS, MN 55403-2420
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
03/26/2013 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 JAN WEBER and RAED RIZQ
__________

Appeal 2011-001729
Application 11/068,330
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 a system
for inserting a catheter, which have been rejected for obviousness. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
“Delivery of a stent to a vessel bifurcation will often employ a pair of
guidewires. . . . The divergent paths of the guidewires at the vessel
bifurcation aid in orienting the delivery catheter.” (Spec. 2:3-12.) However,
“[o]ne of the problems encountered with placing a stent in a bifurcation is
Appeal 2011-001729
Application 11/068,330

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the potential for the guidewires to become twisted and/or knotted,” which
can prevent proper alignment of the stent (id. at 2:15-20). The Specification
discloses a system for inserting a catheter over two guidewires in which the
guidewires are kept separate by a guiderail; insertion of the catheter then
pulls the guidewires out of the guiderail through side openings in each
guidewire lumen (see id. at 4:7-16).
Claims 16-24 are on appeal. Claim 16 is the only independent claim:
16. A system for advancing a medical device over multiple
guidewires, the system comprising:
a first guidewire;
a second guidewire;
a guiderail having a length and including a guiderail housing, the
guiderail housing defining a first guidewire lumen and a second guidewire
lumen, both the first guidewire lumen and the second guidewire lumen
extending the entire length of the guiderail, wherein the guiderail housing
defines a first longitudinal opening extending from the first guidewire lumen
to an exterior of the guiderail along the entire length of the first guidewire
lumen and a second longitudinal opening extending from the second
guidewire lumen to the exterior of the guiderail along the entire length of the
second guidewire lumen, wherein the guiderail is configured to be advanced
over at least one of the first guidewire and the second guidewire in a vessel;
and
a catheter having a first guidewire lumen configured to receive the
first guidewire and a second guidewire lumen configured to receive the
second guidewire, wherein the catheter is configured to be advanced over
the first guidewire and the second guidewire to a target region in the vessel,
wherein the advancement of the catheter over the first guidewire and the
second guidewire pulls the first guidewire completely out of the first
guidewire lumen through the first longitudinal opening and pulls the second
guidewire completely out of the second guidewire lumen through the second
longitudinal opening.

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Application 11/068,330

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The Examiner has rejected claims 16-24 under 35 U.S.C. § 103(a) as
obvious in view of Sirhan,
1
Houser,
2
and Mahurkar
3
(Answer 3), and has
rejected claim 21 as obvious in view of Sirhan, Houser, Marhurkar, and
Casey
4
(Answer 6). The same issue is dispositive for both rejections.
The Examiner finds that Sirhan discloses a guiderail that includes two
lumens that are capable of acting as guidewire lumens, at least one of them
extending the full length of the guiderail, and which both include
longitudinal openings to the exterior (id. at 3). The Examiner finds that
Sirhan does not “specifically state[ ] the second guidewire lumen extends the
length of the guiderail and is equal in length to the first guidewire lumen or
that a second guidewire is provided” (id. at 4), but Houser‟s “two
embodiments in figures 77-78 and 79a-73c [sic, 79c?] both have dual
lumens that may be used for a guidewire . . . [and] states that the channels or
passageways may be, among other options, full catheter length” (id.).
The Examiner concludes that it would have been obvious “to make
the second lumen of Sirhan run the full length of the catheter as taught by
Houser in order to allow the device to work with additional therapeutic and
diagnostic devices” (id.) and “to modify the device of Sirhan by using a
second guidewire with the other lumen as taught by Houser to allow for the
direction of another catheter into a side branching vessel” (id. at 4-5).
Appellants argue that Sirhan discloses “a catheter assembly that
permits the exchange of balloon structures over a catheter body while the

1
Sirhan et al., US 7,131,986 B2, issued Nov. 7, 2006.
2
Houser et al., US 7,229,431 B2, issued June 12, 2007.
3
Mahurkar et al., US 5,221,255, issued June 22, 1993.
4
Casey et al., US 7,018,372 B2, issued Mar. 28, 2006.
Appeal 2011-001729
Application 11/068,330

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catheter body remains in place in the vasculature over a guidewire” and that
“axial slit 24 removably receives the inflation tube 26 of the balloon
structures 14 and 14' to permit the balloon structures to be easily replaced
over the catheter body 12 without having to exchange the entire catheter”
(Appeal Br. 8). Appellants argue that “nothing in Sirhan et al. appears to
disclose using the catheter 10 with two guidewires” (id. at 9) because
[m]odifying the axial slit 24 to serve as a second guidewire
lumen . . . would not appear to allow the inflation tube 26 to be
removably received in the axial slit to allow for exchanging
balloon structures 14 and 14'. Such a modification appears to
render the operation of the device of Sirhan et al. unsatisfactory
for its intended purpose.
(Id. at 9.)
We agree with Appellants that the Examiner has not provided a
persuasive reason for combining Sirhan‟s device with a second guidewire.
Sirhan discloses that combining angioplasty with stent placement makes it
“necessary to „exchange‟ catheters which are used to perform each of the
procedures” (Sirhan, col. 1, ll. 20-28) but conventional over-the-wire and
rapid exchange catheters suffer from drawbacks in this regard (id. at col. 1,
l. 45 to col. 2, l. 34).
Sirhan discloses “a balloon catheter having an exchangeable balloon
structure” (id. at col. 1, ll. 18-19). Sirhan‟s device comprises “a catheter
body having a proximal end, a distal end, and a guidewire lumen extending
therebetween. . . . In all cases, the intravascular balloon catheters of the
present invention will further comprise a balloon structure having a passage
which is slidably receivable over the tubular catheter body.” (Id. at col. 3,
ll. 27-41.)
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Sirhan discloses that the balloon structure has an inflation tube
extending proximally from it, and that the balloon “can be advanced and
withdrawn over the tubular catheter body by pushing and pulling on a
proximal end of the inflation tube while the tubular catheter body remains in
place” (id. at col. 3, ll. 48-56). Thus, for example, a first balloon structure
can be used to perform an angioplasty, then withdrawn, and a second
balloon structure for delivering a stent can be advanced over the catheter
(see id. at col. 4, ll. 53-56; col. 5, ll. 50-60).
Sirhan discloses that “catheter body 12 may include an axial slit 24 to
removably receive an inflation tube 26 which is attached at the proximal end
of the balloon structure 14” and that “the guidewire lumen 20 can have an
axial slit 28” (id. at col. 9, ll. 8-13). Sirhan‟s Figure 5A is shown below:

Figure 5A shows a cross-section of catheter body 12 (id. at col. 7, ll. 38-39),
including axial slit 24 and guidewire lumen 20 with axial slit 28.
Sirhan discloses that, while its device “will usually employ a
conventional inflatable balloon as part of the balloon structure, it will also be
possible to incorporate other radially expansible devices which are generally
recognized in the art to be equivalent to inflatable balloons . . . includ[ing]
expansible shafts, expansible cages,” etc. (id. at col. 10, ll. 10-17). Sirhan
does not disclose using its catheter tube with a guidewire in axial slit 24 as
well as in guidewire lumen 20.
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The Examiner finds, however, that “Houser discloses a device similar
to Sirhan that also utilizes balloons and opposing lumens that may be used
for guidewires or other devices. For example, the two embodiments in
figures 77-78 and 79a-73c [sic, 79c?] both have dual lumens” that can each
be used for guidewires (Answer 4, citing Houser, col. 18, ll. 46, 49-51, 58;
col. 19, ll. 9-13). The Examiner also finds that Houser discloses using a
second guidewire in the second lumen to position the second guidewire in a
side channel or branch to direct another catheter (id., citing Houser at Fig.
76, col. 18, ll. 64-67).
Houser discloses “a rapid exchange catheter . . . [that] allows the
catheter to be removed from around a guide wire by using a slot or channel
to hold the guide wire” (Houser, col. 1, ll. 16-20). Houser‟s Figures 77 and
78 are shown below:

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Application 11/068,330

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Figures 77 and 78 show side and cross-sectional views, respectively,
of a catheter having two passages in the catheter shaft wall (id. at col. 7, ll.
45-47). Houser states that the catheter shown in Figures 77 and 78
includes a pair of passage ways 535 passing longitudinally
through the wall of the catheter shaft. One passage way can be
used to deploy or track a guide wire and the other to carry,
deploy, or position a therapeutic or protective device, such as
the embolic trap 700. The other passage way also can be used
to deploy or track a second guide wire.
(Id. at col. 18, ll. 44-50.) The second guide wire “may be positioned into a
side branching vessel, to direct another catheter (e.g., for PTCA, stent
deployment, or other) into the side branch” (id. at col. 18, ll. 64-66).
We agree with Appellants, however, that the Examiner has not
provided a persuasive reason for concluding that it would have been obvious
to modify Sirhan‟s device to include two guidewires as disclosed by Houser.
Sirhan describes its device as a catheter with “an exchangeable balloon
structure” (Sirhan, col. 1, ll. 18-19) that is designed to allow balloons to be
advanced serially over the catheter and exchanged while the catheter
remains in place (id. at col. 3, ll. 48-56). Sirhan discloses that the purpose of
axial slit 24 is “to removably receive an inflation tube” attached to the
balloon that is advanced over the catheter (id. at col. 9, ll. 8-9).
If Sirhan‟s device was modified to advance a second guidewire in
axial slit 24, it could no longer be used to advance and expand a balloon
structure, which is the entire purpose of Sirhan‟s device. We therefore agree
with Appellants that the Examiner‟s proposed modification of Sirhan would
“render the operation of the device of Sirhan et al. unsatisfactory for its
intended purpose” (Appeal Br. 9).
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Application 11/068,330

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The Examiner relies on Marhurkar for disclosure of a stiffening or
reinforcing portion, as recited in claim 19 (see Answer 5), not for any
purpose related to the deficiency discussed above. With regard to the
rejection of claim 21, the Examiner cites Casey for its disclosure of two
lumen on the same side of a reinforcing member (id. at 7), which again does
not make up for the deficiency discussed above. We therefore reverse both
of the rejections on appeal.
SUMMARY
We reverse the rejection of claims 16-24 under 35 U.S.C. § 103(a)
based on Sirhan, Houser, and Mahurkar; and the rejection of claim 21 under
35 U.S.C. § 103(a) based on Sirhan, Houser, Mahurkar, and Casey.

REVERSED

cdc