BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Sep 11, 2020

2020000308 (P.T.A.B. Sep. 11, 2020)

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.
15/040,943 02/10/2016 MARK D. WOOD 1001.2705102 3120
11050 7590 09/11/2020
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
09/11/2020 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARK D. WOOD and JOHN DEANE
Appeal 2020-000308
Application 15/040,943
Technology Center 3700
Before JENNIFER D. BAHR, JOHN C. KERINS, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the
Examiner’s decision to reject claims 1, 5, 10, 13, and 18.1, 2 We have
jurisdiction under 35 U.S.C. § 6(b). We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Boston Scientific SciMed, Inc. as the
real party in interest. Appeal Br. 3.
2 Claims 2–4, 6, 7, 14, 15, and 19 have been canceled, and claims 8, 9, 11,
12, 16, 17, and 20 have been withdrawn from consideration. See
Amendment After Final Office Action (filed Mar. 21, 2019, hereinafter
“Amdt. After Final Act.”); Final Act. 1 (Office Action Summary).
Appeal 2020-000308
Application 15/040,943

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CLAIMED SUBJECT MATTER
Appellant’s invention is directed to medical devices for accessing
body lumens along the biliary tree. Spec. 1:11–12. Claim 1, reproduced
below, is illustrative of the claimed subject matter:
1. A dual-wire catheter system for accessing a body lumen
along the biliary and/or pancreatic tract, the catheter system
comprising:
a catheter shaft having a proximal end, a distal end, a first
guidewire lumen defined therein, and a secondary guidewire
holding structure;
wherein the first guidewire lumen extends centrally along
a length of the catheter shaft;
wherein the secondary guidewire holding structure is a
channel formed in and extending along a length of an outer wall
of the catheter shaft, the channel having a distal end proximal of
the distal end of the catheter shaft, the channel having a length
and being radially open along an entirety of its length, wherein
the channel distally reduces in depth;
a first guidewire disposed in the first guidewire lumen;
and
a second guidewire disposed in the secondary guidewire
holding structure.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Wilson US 6,221,090 B1 Apr. 24, 2001
Deal US 2005/0059890 A1 Mar. 17, 2005
Von Oepen US 2008/0027411 A1 Jan. 31, 2008
Brown US 2013/0158507 A1 June 20, 2013

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REJECTIONS
Claims 1, 5, 10, 13, and 18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Brown and Von Oepen.
Claims 1, 5, 13, and 18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Wilson and Von Oepen.
Claim 10 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Wilson, Von Oepen, and Deal.
OPINION
Obviousness—Brown and Von Oepen
The Examiner finds that Brown’s catheter system comprises a
secondary guidewire holding structure in the form of a channel (lumen 34),
but that “Brown fails to disclose that the channel is radially open along an
entirety of its length” as recited in each of Appellant’s independent claims 1,
13, and 18. Final Act. 6–7. The Examiner finds that Von Oepen teaches, in
a catheter guidewire system, “a guidewire channel (20 or 21) which
encompasses a discontinuity (22) such that it is radially open[,] the
discontinuity running along an entire length of the channel in order to permit
quick removal of a guidewire received within the channel.” Id. at 7 (citing
Von Oepen ¶¶ 14, 15, 41, 48, 70). The Examiner then determines that it
would have been obvious “to form the guidewire holding structure of Brown
to include a discontinuity such that the channel is radially open along an
entirety of its length, as disclosed by Von Oepen, in order to permit rapid
removal of the guidewire from the catheter.” Id.
Appellant submits Von Oepen does not describe discontinuity 22 as
“providing any feature related to the rapid, fast, or quick removal of the
guidewire from the channel 20 or 21.” Appeal Br. 8. Appellant further
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points out that Von Oepen describes “two methods of removing the
guidewires from the channels, neither of which is described as being fast,
rapid, or quick.” Id. (citing Von Oepen ¶¶ 70, 71). With respect to the
method Von Oepen discusses in paragraph 70, Appellant argues that “the
use of a secondary device or surface would appear to require an extra step
and thus be slower than simply pulling the guidewire loading device
proximally.” Id. Appellant further contends that the alternative method Von
Oepen discusses in paragraph 71 “of simply pulling the guidewire loading
device over the guidewire would not appear to result in the guidewire being
passed through the discontinuity 22 and thus would provide no difference or
advantage over the device of Brown, in which the guidewire is simply
removed from the continuous lumen.” Id. at 8–9.
Appellant’s arguments are persuasive. The method Von Oepen
describes in paragraph 70 makes use of discontinuity 22 by removing the
guidewires through the discontinuity formed in the proximal end of the
guidewire placement device and propagating them along the length of the
discontinuity until each of the guidewires is free of its respective lumen. See
Von Oepen ¶ 70. Von Oepen teaches facilitating this propagation “by
passing a secondary device over the guidewires external to the placement
device or by passing a surface distally between the guidewires and the outer
surface of the guidewire placement device.” Id. We agree with Appellant
that this method of removing the guidewires does not appear to be any more
rapid or quick than simply pulling the guidewire placement device
proximally. Further, Brown mentions, without further detail, that “[i]n some
embodiments the first and second lumens 32, 34 may be configured for rapid
exchange of devices extending through the lumens 32, 34,” but gives no
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indication that passing guidewires (wire guide 72), or other devices
extending through lumen 34, externally of catheter 10 through a slit or
discontinuity in the catheter wall proximal of side port 42 would be
desirable. Brown ¶ 21. As Appellant correctly points out, the method Von
Oepen describes in paragraph 71 for removing the guidewires does not make
use of the discontinuity and, thus, would not provide any incentive for
adding a discontinuity to the catheter wall of Brown to render lumen 34
radially open along an entirety of its length.
In light of our findings above, the Examiner’s articulated reason (i.e.,
“in order to permit rapid removal of the guidewire from the catheter”) for
modifying Brown to include a discontinuity such that lumen 34 is radially
open along an entirety of its length, as disclosed by Von Oepen, lacks
rational underpinnings.
The Examiner responds by directing our attention to Wilson’s
disclosure of providing guidewire lumens/channels with a radially open slit
as a means of effecting “rapid exchange” by enabling guidewires to be
removed laterally through the sides of the catheter. Ans. 6 (citing
Wilson 16:13–16). The Examiner relies on Wilson as “an evidentiary
reference which merely serves to link the phrase ‘rapid exchange’ with slits
through the catheter sidewall to thereby establish the level of knowledge and
understanding expected of a customary artisan.” Id.
Appellant acknowledges that “rapid exchange catheters were
generally known,” but contends that such catheters include a slit that runs
only along a short section of the lumen, and not along the entire length of the
lumen. Reply Br. 2 (quoting text from Wilson 14:17–22 (disclosing a slit
(not shown) extending only part of the length of first guide wire lumen 34A,
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from side port 34C to just proximal of the balloon portion of the catheter));
see also Wilson 16:13–16 (disclosing a slit (not shown) to permit stent-
positioning guide wire 41A to be unzipped from the proximal 100 cm of the
catheter, thereby allowing the wire “to act as a rapid exchange wire”). Thus,
Appellant submits that providing a slit to provide a “rapid exchange” feature
as taught by Wilson would not result in the structure claimed. Reply Br. 2–
3.
Appellant’s argument is persuasive. Wilson appears to describe a slit
extending along the proximal portion of the lumen to provide a “rapid
exchange-type catheter” or “rapid exchange wire,” but not a slit extending
along the entire length of the lumen. See, e.g., Wilson 14:17–22; 16:13–16.
Thus, even if one were to follow the teachings of Wilson and provide a slit
for “rapid exchange” of Brown’s guidewires, it is not apparent why a person
having ordinary skill in the art would have been prompted to provide a slit
along the entire length of Brown’s lumen 34 so as to result in a “channel
having a length and being radially open along an entirety of its length,” as
recited in Appellant’s independent claims 1, 13, and 18. See Appeal Br. 13,
14 (Claims App.).
The Examiner, therefore, fails to establish that the subject matter of
independent claims 1, 13, and 18 would have been obvious. Accordingly,
we do not sustain the rejections of claims 1, 13, and 18, or of claims 5 and
10, which depend from claim 1, as unpatentable over Brown and Von
Oepen.
Obviousness—Wilson and Von Oepen
The Examiner finds that Wilson’s Figure 44 embodiment is a catheter
system substantially as claimed in claims 1, 13, and 18, except that the
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channel (lumen 26) forming the secondary guidewire holding structure is not
radially open along an entirety of its length. Final Act. 8–9. The Examiner
determines that it would have been obvious “to form the guidewire holding
structure of Wilson to include a discontinuity such that the channel is
radially open along an entirety of its length, as disclosed by Von Oepen, in
order to permit rapid removal of the guidewire from the catheter.” Id. at 9.
Appellant argues that Wilson already teaches a catheter having rapid
exchange features and, thus, “there is no rational reason for one of ordinary
skill in the art to modify Wilson with Von Oepen as asserted by the
Examiner, to permit rapid removal of the guidewire.” Appeal Br. 11.
Appellant also repeats the arguments, which we find persuasive for the
reasons discussed above, that Von Oepen’s discontinuity is not described as,
and does not appear to be, a rapid exchange feature. See id.
The Examiner responds by acknowledging that Wilson discloses rapid
exchange features, but not on the embodiment of Figure 44 relied on in the
rejection. Ans. 14, 16. According to the Examiner, even assuming that
Figure 44 of Wilson does “provide for rapid-exchange configurations, the
presence of one solution does not speak as to the obviousness of
modification to incorporate known, alternative solutions demonstrated by the
prior art.” Id. at 16–17.
Appellant explains that Wilson configures the Figure 44 embodiment
to provide maximum torque and teaches providing slit 144 to allow
positioning guide wire 151 to bend slightly and flex into the slit as the wire
encounters frictional resistance along the slope of ramp 143. Reply Br. 5
(citing Wilson 26:5–14; Fig. 47). Appellant contends that because “Wilson
specifically states the slit is designed to allow the positioning wire 151 to
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flex into the slit as it encounters and travels up the ramp 143 in the
specifically designed torqueing member 140, Wilson cannot be seen to
provide any rational reason to extend the slit along the length of the
catheter.” Id. at 5–6. Appellant also submits that by teaching a rapid
exchange catheter in other embodiments and designing the embodiment
illustrated in Figures 37–47 for providing maximum torque rather than as a
rapid exchange catheter, “Wilson appears to have decided against making
the torqueing catheter one that includes rapid exchange features.” Id. at 6.
Moreover, Appellant contends that providing a discontinuity, as taught by
Von Oepen and proposed by the Examiner, along the entire length of
positioning guide wire lumen 142 of Wilson would appear to render
Wilson’s torqueing catheter “unsuitable for its intended use as such a
discontinuity would appear to allow the guide wire to exit the catheter as the
catheter is torqued over the wire.” Id.
Appellant’s arguments are persuasive. Given the role of slit 144 in
allowing positioning guide wire 151 to flex into the slit to provide a more
gradual bend in the wire to relieve the bending moments in the wire, it is
doubtful that a person having ordinary skill in the art would have been
prompted to provide a slit along the entire length of Wilson’s positioning
guide wire lumen 142 that would allow the wire to exit (i.e. be removed
from) the catheter as taught by Von Oepen. See Von Oepen ¶ 70.
For all of the above reasons, the Examiner fails to establish that the
subject matter of claims 1, 13, and 18 would have been obvious.
Accordingly, we do not sustain the rejection of independent claims 1, 13,
and 18, or of claim 5, which depends from claim 1, as unpatentable over
Wilson and Von Oepen.
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Obviousness—Wilson, Von Oepen, and Deal
The Examiner’s application of Deal does not cure the aforementioned
deficiencies in the combination of Wilson and Von Oepen. See Final Act.
9–10 (applying Deal for its teachings of guidewire lumens extending the
entire length of the catheter shaft and determining it would have been
obvious to configure Wilson’s first guidewire lumen (tracking wire lumen
125) the full length of the catheter shaft). Accordingly, we do not sustain
the rejection of claim 10 as unpatentable over Wilson, Von Oepen, and Deal.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 5, 10, 13,
18
103(a) Brown, Von Oepen 1, 5, 10, 13,
18
1, 5, 13, 18 103(a) Wilson, Von Oepen 1, 5, 13, 18
10 103(a) Wilson, Von
Oepen, Deal
10
Overall
Outcome
1, 5, 10, 13,
18

REVERSED