Ex Parte Deal et al

Patent Trial and Appeal Board

Sep 23, 2014

10902492 (P.T.A.B. Sep. 23, 2014)

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.
10/902,492 07/29/2004 Stephen E. Deal 10000/394 1133
48003 7590 09/23/2014
BGL/Cook - Chicago
PO BOX 10395
CHICAGO, IL 60610
EXAMINER
HOUSTON, ELIZABETH
ART UNIT PAPER NUMBER
3753
MAIL DATE DELIVERY MODE
09/23/2014 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 STEPHEN E. DEAL, GREGORY J. SKERVEN,
VICTOR D. CLARK, JR., and DAVID F. WALLER
__________

Appeal 2012-003396
Application 10/902,492
Technology Center 3700
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
SUSAN L.C. MITCHELL, Administrative Patent Judges.

PER CURIAM.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1, 3–5, 7–11, and 20–24.2 We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 The Real Party in Interest is Wilson-Cook Medical Inc. (App. Br. 2).
2 Claims 12–19 are also pending, but have been withdrawn from
consideration (App. Br. 2).
Appeal 2012-003396
Application 10/902,492

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STATEMENT OF THE CASE
The Specification discloses “a system for delivering a biliary or
pancreatic drainage stent 69 mounted on a delivery catheter 110” (Spec. 43,
¶ 00117). Figure 17 of the Specification is shown below:

Figure 17 shows “a side view of a biliary stent and delivery catheter” (id. at
17 ¶ 0043). The Specification discloses that the wire guide “coupling
portion 14 of the delivery catheter 110 comprises the passageway 27
between the distal opening 19 and the side access port 15” (id. at 43 ¶
00117). The Specification discloses that the “wire guide 11 exits the side
access port 15 at a point distal to the distal end 71 of the [biliary] stent 69 to
advantageously provide a means for withdrawing the stent 69 along with the
delivery catheter 110” (id.). The Specification discloses that “[w]hen the
catheter 10 and wire guide 11 are withdrawn together relative to the stent . . .
the distal edge 71 of the stent 69, which is slidably positioned over the
catheter, lodges in a triangular wedge point 70 formed by the junction of the
delivery catheter and the wire exiting therefrom” (id.). The Specification
discloses that “the stent 69 is pulled backward along with the delivery
catheter, providing the clinician with a simple and reliable means to pull the
stent partially out of the duct” (id.).

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Application 10/902,492

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Claim 1 is representative of the claims on appeal and reads as follows:
1. An apparatus for delivering a prosthesis into a work site within a
bodily lumen of a patient comprising:
an elongate inner member comprising a shaft extending between a
distal end and a proximal end, a lumen extending through at least a portion
of the shaft, a distal opening in communication with the lumen and disposed
near the distal end of the shaft, a proximal opening in communication with
the lumen and disposed a substantial distance from the proximal end of the
shaft and a relatively shorter distance from the distal end of the shaft;
an elongate outer member slidably disposed over the shaft of the
elongate inner member, the elongate outer member including a distal end
portion having a distal end disposed proximally of the proximal opening;
a wire guide removably disposed through the lumen of the elongate
inner member between the distal opening and the proximal opening, the wire
guide being configured to guide the elongate inner member through the
bodily lumen of the patient and to the work site; and
a prosthesis removably disposed over the shaft of the elongate inner
member proximally of the proximal opening, the prosthesis being engaged
by the distal end of the elongate outer member;
wherein, when the wire guide is disposed through the lumen of the
elongate inner member, the wire guide is coupled to the elongate inner
member only between the distal opening and the proximal opening and does
not extend through any portion of the prosthesis or the elongate outer
member;
wherein, when the wire guide is disposed through the lumen of the
elongate inner member, a portion of the wire guide extending outwardly
from the proximal opening engages a distal end of the prosthesis and secures
the prosthesis against longitudinal distal movement relative to elongate inner
member; and
wherein the prosthesis is permitted to be removed from the elongate
inner member when the wire guide is not disposed through the lumen of the
elongate inner member.

Appeal 2012-003396
Application 10/902,492

4
The claims stand rejected under 35 U.S.C. § 103(a) as follows:
I. Claims 1, 3–5, 7–9, 20, 23, and 24 over the combination of
Dua3 and Jung4 (Ans. 4–7);
II. Claims 21 and 22 over the combination of Dua, Jung, and
further in combination with Poncet5 (Ans. 9–10); and
III. Claims 1, 10, and 11 over the combination of Braunschweiler6
and Jung (Ans. 7–9).
I.
Issue
The Examiner has rejected claims 1, 3–5, 7–9, 20, 23, and 24 under
35 U.S.C. § 103(a) as obvious over the combination of Dua and Jung
(Rejection I, Ans. 4–7). The Examiner has also rejected claims 21 and 22
under 35 U.S.C. § 103(a) as obvious over the combination of Dua, Jung, and
Poncet (Rejection II, Ans. 9–10). We focus our initial analysis on claim 1.
The issue presented is: Has the Examiner established by a
preponderance of the evidence that the combination of Dua and Jung would
have made obvious an apparatus for delivering a prosthesis that comprises
an elongate inner member comprising a shaft and a lumen, with a wire guide
disposed in the lumen and a prosthesis disposed on the shaft, such that the
wire guide extends outwardly from a proximal opening in the shaft and
“engages a distal end of the prosthesis and secures the prosthesis against

3 Dua et al., US 2002/0032487 A1, published Mar. 14, 2002.
4 Jung et al., US 5,383,853, patented Jan. 24, 1995.
5 Poncet, US 5,833,694, patented Nov. 10, 1998.
6 Braunschweiler et al., US 5,484,444, patented Jan. 16, 1996.
Appeal 2012-003396
Application 10/902,492

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longitudinal distal movement relative to elongate inner member,” as required
by claim 1?
Findings of Fact
FF1. The Examiner finds that “Dua discloses an apparatus . . . for
delivering a prosthesis into a work site within a bodily lumen of a patient”
(Ans. 4 (citing Dua, Figs. 11–14)).
FF2. The Examiner finds that Dua’s apparatus comprises “an
elongate inner member (73) . . . an elongate outer member (72) slidably
disposed over the shaft of the elongate inner member . . . and a wire guide
(74)” disposed in the elongate inner member lumen (id. (citing Dua, Fig. 14
and 5–6 ¶ 0048)).
FF3. The Examiner finds that Dua’s “prosthesis (60) is disposed over
the shaft of the elongate inner member and is engaged by or abuts the distal
end of the elongate outer member” (id. at 5 (citing Dua, Fig. 14 and 5–6,
¶ 0048)).
FF4. The Examiner finds that the Dua’s prosthesis comprises a “non-
expandable stent . . . slidably disposed on the elongate inner member” (id.
(citing Dua 5–6 ¶¶ 0046 and 0048)).
FF5. Dua discloses “a tubular drainage stent . . . that is placed within
a bodily passage, such as the bile duct, pancreatic duct, urethra, etc. to
facilitate the flow of fluids therethrough” (Dua 5 ¶ 0046).
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Appeal 2012-003396
Application 10/902,492

7
that comprises a port through the wall of the shaft . . . and a coupling region
defined by a portion of the lumen extending between the distal and proximal
opening” (id. at 5–6 (citing Jung, Fig. 5)).
FF13. The Examiner finds that Jung discloses that a wire guide is
“coupled to the coupling region only between the distal opening and the
proximal opening” (id. at 6).
FF14. Jung discloses “a rapid exchange medical catheter having a
wire guiding means external to the shaft for slidably mounting over the
guidewire, the wire guiding means being a short tubular member” (Jung, col.
3, ll. 25–28).
FF15. Figure 5 of Jung is shown below:

Figure 5 shows a cross-sectional view of an angioplasty catheter (id. at ll.
54–55).
FF16. Jung discloses that the “molded distal tip 45 has a rearwardly
extending guidewire lumen 50 through which the guidewire 55 is threaded”
(id. at col. 7, ll. 41–43).
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FF17. Jung discloses that the advantages of the disclosed wire
guiding means are
[F]irst, only one operator is required for the procedure, second,
an inner lumen is not required to accommodate the guidewire,
third, a short exchange lumen results in less friction and a faster
exchange, and fourth, pinching the guidewire is minimized as
the catheter is being removed through the tortuous path thereby
tending to minimize pulling out the guidewire upon withdrawal
of the catheter.

(Id. at col. 3, ll. 31–39.)
FF18. The Examiner concludes that
It would have been obvious to one having ordinary skill
in the art . . . to incorporate a lumen at the distal end of the
medical device (73) of Dua in order to provide the advantage of
quick exchange [as disclosed in Jung] which eliminates the
need for a second operator, reduces the size of the guidewire
needed, and provides an easier and faster exchange

(Ans. 6 (citing Jung, col. 3, ll. 25–40).)
FF19. The Examiner concludes further that
Providing the quick exchange lumen in the tip of the
inner member (73) of Dua would result in an invention . . .
[wherein] a portion of the wire guide extends outwardly from
the proximal opening and engages a distal end of the prosthesis
and secures the prosthesis against longitudinal distal movement.

(Id.)
Analysis
Appellants argue that it would not have been obvious for one of skill
in the art to combine the wire guide coupling arrangement disclosed in Jung
with Dua’s stent delivery device because “Jung is not directed to a prosthesis
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Application 10/902,492

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delivery device, but to a balloon catheter used to perform balloon
angioplasty procedures” (App. Br. 6).
That argument is not persuasive. The Supreme Court has emphasized
that “the [obviousness] analysis need not seek out precise teachings directed
to the specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007).
“If a person of ordinary skill can implement a predictable variation, § 103
likely bars its patentability.” Id. at 417. Under the correct obviousness
analysis, “any need or problem known in the field of endeavor at the time of
invention and addressed by the patent can provide a reason for combining
the elements in the manner claimed.” Id. at 420.
Here, the Examiner has provided a reason to combine the references
(FF 18). That is, Jung discloses that a short tubular wire guiding means
provides the advantages that only one operator is required for catheter
exchange, that catheter exchanges are faster, and that pinching of the guide
wire during catheter exchange is minimized to reduce the likelihood of
pulling out the guide wire during the exchange (FF 17). It would have been
a predictable variation of the cited prior art to apply the short tubular wire
guiding means of Jung to Dua’s prosthesis delivery catheter in order to
obtain the advantages disclosed by Jung and facilitate successful use of
Dua’s prosthesis delivery apparatus.
Appellants also argue that Dua “fails to disclose a wire guide that is
engaged with and secures a prosthesis against longitudinal proximal
movement relative to the inner shaft” (App. Br. 6). Appellants argue that
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Application 10/902,492

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“Jung provides no teaching that would or could motivate one skilled in the
art to modify Dua to include a wire guide coupling arrangement configured
to secure the prosthesis onto the delivery catheter” (id. at 7). Appellants
argue that “although Jung discloses a wire guide port that is distal to the
balloon, the balloon is not deployable or removable from the catheter . . .
[and therefore] the balloon is not secured to the catheter by the wire guide”
(id. at 6).
The Examiner responds that “incorporating the distal guide wire port
as taught by Jung into the stent delivery device of Dua would result in a
structure that is configured to or capable of securing the prosthesis onto the
delivery catheter” (Ans. 11). The Examiner reasons that a “guidewire
entering . . . [a] port at the distal end of the catheter (or distal of the stent)
necessarily prevents the stent from being able to be pushed off the delivery
device” (id.). The Examiner further reasons that “the fact that applicant has
recognized another advantage which would flow naturally from following
the suggestion of the prior art cannot be the basis for patentability when the
differences would otherwise be obvious” (id., citing Ex parte Obiaya, 227
USPQ 58, 60 (BPAI 1985)).
We agree with the Examiner’s reasoning. Dua discloses that the
prosthesis is slidably disposed on the elongate catheter member (FF 4 and 8).
Providing Dua’s device with an opening for guide wire that is distal to the
prosthesis, but proximal to the distal end of the elongate catheter member,
would necessarily result in a guide wire that “engages a distal end of the
prosthesis and secures the prosthesis against longitudinal distal movement
relative to elongate inner member,” as required by claim 1. That is, when
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Application 10/902,492

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the elongate member or catheter is retracted, the wire guide would engage
the prosthesis and prevent the prosthesis from sliding off of the elongate
member or catheter. Thus, Appellants’ arguments are not persuasive.
Claims 3–5, 7–9, 20, 23, and 24 have not been argued separately from
claim 1, and therefore, fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner has also rejected dependent claims 21 and 22 under
35 U.S.C. § 103(a) as obvious over the combination of Dua, Jung, and
Poncet (Rejection II, Ans. 9–10). Appellants have not presented any
arguments based on Poncet, but merely state that these claims would be
patentable for the same reasons as independent claims 1 and 20 (App. Br. 7),
and we, thus, also affirm that rejection.
Conclusion of Law
The preponderance of the evidence supports the Examiner’s
conclusion that the combination of Dua and Jung would have made obvious
an apparatus for delivering a prosthesis that comprises an elongate inner
member comprising a shaft and a lumen, with a wire guide disposed in the
lumen and a prosthesis disposed on the shaft, such that the wire guide that
extends outwardly from a proximal opening in the shaft and “engages a
distal end of the prosthesis and secures the prosthesis against longitudinal
distal movement relative to elongate inner member,” as required by claim 1.
Thus, we affirm the rejection of claim 1 as being obvious over the
combination of Dua and Jung. Because claims 3–5, 7–9, 20, 23, and 24 are
not argued separately, they fall with claim 1. We also affirm the rejection of
claim 21 as being obvious over the combination of Dua, Jung, and Poncet.
Claims 22 is not separately argued and falls with claim 21.
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II.
Issue
The Examiner has rejected claims 1, 10, and 11 under 35 U.S.C.
§ 103(a) as obvious over the combination of Braunschweiler and Jung
(Rejection III, Ans. 7–9). We focus our analysis on claim 1.
The issue presented is: Has the Examiner established by a
preponderance of the evidence that the combination of Braunschweiler and
Jung would have made obvious an apparatus for delivering a prosthesis that
comprises an elongate inner member comprising a shaft and a lumen, with a
wire guide disposed in the lumen and a prosthesis disposed on the shaft,
such that the wire guide extends outwardly from a proximal opening in the
shaft and “engages a distal end of the prosthesis and secures the prosthesis
against longitudinal distal movement relative to elongate inner member,” as
required by claim 1?
Findings of Fact
FF20. The Examiner finds that Braunschweiler “discloses an
apparatus . . . for delivering a prosthesis into a work site within a bodily
lumen of a patient” (Ans. 7 (citing Braunschweiler, Figs. 1–4)).
FF21. The Examiner finds that Braunschweiler apparatus comprises
“an elongate inner member (3) . . . an elongate outer member (2) slidably
disposed over the shaft of the elongate inner member . . . and a wire guide
(17) removably disposed through the lumen of the elongate inner member”
(id. at 7–8).
FF22. The Examiner finds that the Braunschweiler apparatus further
comprises a self-expanding “prosthesis (1) . . . disposed over the shaft of the
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elongate inner member and . . . engaged by the distal end of the elongate
outer member” (id. at 8, citing Braunschweiler, Figs. 2 and 4).
FF23. The Examiner finds Braunschweiler’s stent is “allowed to
expand when not disposed within the elongate outer member” (id. (citing
Braunschweiler, Fig. 4)).
FF24. Braunschweiler discloses “a device for implanting self-
expanding endoprostheses” (Braunschweiler, col. 1, ll. 6–7).
FF25. Figure 4 of Braunschweiler is shown below:

Figure 4 shows “a partial cutaway view [of the device] with a partially
unfolded endoprosthesis” (id. at col. 3, ll. 55–56).
FF26. Braunschweiler discloses that the device for “implanting
endoprosthesis 1 has basically a tubular, flexible outer body 2 and an
elongated, flexible core element 3” (id. at col. 3, ll. 61–63).
FF27. Braunschweiler discloses that “[e]xtending the entire length of
core element 3 is a lumen 16 in which a guide wire 17 can be inserted” (id.
at col. 4, ll. 17–18).
FF28. The Examiner finds that Braunschweiler “does not disclose a
proximal opening in the elongate inner shaft . . . [at] a substantial distance
from the proximal end of the shaft and a relatively shorter distance from the
distal end of the shaft thereby defining a coupling region” (Ans. 8).
FF29. The Examiner relies on Jung as discussed above (id.).
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FF30. The Examiner concludes that it “would have been obvious to
one having ordinary skill in the art . . . to incorporate a lumen at the distal
end of the [Braunschweiler] medical device . . . in order to provide the
advantage of quick exchange,” as disclosed in Jung (id.).
Analysis
Appellants argue that Braunschweiler “is similar to Dua and likewise
fails to disclose the same limitations demonstrated above to be absent from
Dua” (App. Br. 7). Appellants argue that Braunschweiler does not disclose a
proximal guide wire “opening in the elongate inner shaft that is distal of the
prosthesis and the outer member” and does not disclose a guide wire “that is
engaged with and secures a prosthesis against longitudinal proximal
movement relative to the inner shaft” (id.). Appellants argue that, for the
reasons discussed with regard to the combination of Dua and Jung, “there is
no basis for combining Jung with art—such as Braunschwe[i]ler—directed
to prosthesis delivery systems” (id.).
Appellants’ arguments are not persuasive. As discussed above, we
agree with the Examiner that one of skill in the art would have found it
obvious to combine the Jung’s wire guiding means with prosthesis delivery
systems such as those disclosed in Dua and Braunschweiler in order to
obtain the advantages disclosed in Jung for the short tubular wire guiding
means.
Thus, we affirm the rejection of claim 1 as obvious over the
combination of Braunschweiler and Jung. Claims 10 and 11 have not been
argued separately from claim 1, and therefore, fall with that claim.
37 C.F.R. § 41.37(c)(1)(vii).
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Conclusion of Law
The preponderance of the evidence supports the Examiner’s
conclusion that the combination of Braunschweiler and Jung would have
made obvious an apparatus for delivering a prosthesis that comprises an
elongate inner member comprising a shaft and a lumen, with a wire guide
disposed in the lumen and a prosthesis disposed on the shaft, such that the
wire guide that extends outwardly from a proximal opening in the shaft and
“engages a distal end of the prosthesis and secures the prosthesis against
longitudinal distal movement relative to elongate inner member,” as required
by claim 1. We thus affirm the rejection of claim 1 over the combination of
Braunschweiler and Jung. Because claims 10 and 11 are not argued
separately, they fall with claim 1.
SUMMARY
We affirm the rejections of record.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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