Ex Parte Wu et al

Board of Patent Appeals and Interferences

Mar 5, 2012

11613827 (B.P.A.I. Mar. 5, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PATRICK P. WU, KEIF FITZGERALD,
AUGUST YAMBAO, and MICHAEL GREEN
__________

Appeal 2010-009905
Application 11/613,827
Technology Center 3700
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Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 19, 22-26, 29, and 31, directed to a system for deploying a medical
device. The claims have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.
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STATEMENT OF THE CASE
Claims 19, 22-26, 29, and 31 are pending and on appeal; claims 1-18,
20, 21, 27, 28, and 30 have been canceled (App. Br. 3). Claim 19, the only
independent claim on appeal, is representative (emphasis added):
19. A system for deploying a medical device, comprising:
a handle assembly;
an inner catheter assembly operatively associated with the handle
assembly, the inner catheter assembly including an inner catheter member
coaxially arranged within a restraining member;
a self-expanding stent carried on the inner catheter member and
maintained in a delivery position by the restraining member;
an outer assembly configured about the inner catheter assembly; and
a strain relief connecting the handle assembly to the outer assembly,
the strain relief including a channel defining a maze-like thread;
wherein the strain relief is detachably connected to the handle
assembly.
The Examiner relies on the following evidence:
Del Rio et al. US 5,741,084 Apr. 21, 1998
Fitz US 6,146,415 Nov. 14, 2000
Holman et al. US 6,273,404 B1 Aug. 14, 2001
Randall et al. US 6,514,261 B1 Feb. 4, 2003
The claims stand rejected as follows:
Claims 19, 26, and 29 under 35 U.S.C. § 103(a) as unpatentable over
Fitz and Holman;
Claims 22-25 under 35 U.S.C. § 103(a) as unpatentable over Fitz,
Holman, and Del Rio;
Claim 31 under 35 U.S.C. § 103(a) as unpatentable over Fitz, Holman,
and Randall.

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OBVIOUSNESS
Issue
The dispositive issue raised by all three of the obviousness rejections
is whether the evidence of record supports the Examiner‟s finding that Fitz‟s
screw thread is the same as “a maze-like thread.”
Findings of Fact
1. Figure 7 of the Specification is a detailed perspective view
showing the proximal end 60 of the strain relief 30 of Appellants‟ device
deployment system. “[T]he proximal end 60 includes a continuous channel
62 which creates a maze-like thread that allows the strain relief 30 to be
removably attached to the control handle 12” (Spec. 16).
1
Thus, „[t]he
physician can remove the outer sheath 28 by simply twisting the strain
relief” (id. at 16-17). Figure 7 is reproduced below:

Figure 7 of the Specification “is a perspective view showing the proximal
end of the strain relief portion of the catheter system” (id. at 8).

1
The pages of the Specification are unnumbered. We have numbered them
consecutively from the Title page.
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2. Figure 15 of Fitz is a side elevational view of a stent delivery
system, and Figure 16 of Fitz is a magnified, side elevational view of a
coupling spacer 70 included in the stent delivery system. Figures 15 and 16
are reproduced below:

Figure 15 of Fitz is a side elevational view of a stent delivery system, and
Figure 16 of Fitz is a magnified, side elevational view of the “coupling
spacer 70 . . . which extends between manipulator handle 20 and guide
catheter 38” (Fitz, col. 8, ll. 54-55). “Coupling spacer 70 . . . [comprises]
outer tube 72 . . . [and] inner tube 74. The outer portion of inner tube 74 and
the inner portion of outer tube 72 are threaded such that the portions may be
rotated relative to one another to adjust the width of the coupling spacer” (id.
at col. 8, ll. 63-68).
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Discussion
The Examiner finds that Fitz discloses a delivery system for a self-
expanding stent that comprises, in relevant part, a handle assembly; an inner
catheter assembly comprising an inner catheter member coaxially arranged
within a restraining member; a self-expanding stent carried on the inner
catheter member and maintained in delivery position by the restraining
member; and an outer assembly configured about the inner catheter
assembly (Ans. 3). The Examiner finds that Fitz further discloses that the
“outer assembly is detachably connected to the handle” through coupling
spacer 70 (id. at 4), where “the coupling mechanism of Fitz is a screw thread
(i.e. a maze like thread as shown in Fig. 16)” (id. at 5).
The Examiner acknowledges that “Fitz does not disclose a strain relief
detachably connecting the handle to the outer assembly” (id. at 4), but finds
that Holman discloses a hub assembly for a catheter tube, and cites Holman
as evidence that “it is old and well known to incorporate strain relief
between the hub (analogous to the handle) and the catheter (analogous to the
outer assembly) in order to provide a smooth transition in flexibility between
the stiff hub and the flexible tube” (id.).
The Examiner concludes that it would have been obvious for one of
ordinary skill in the art to incorporate a strain relief mechanism into Fitz‟s
delivery system to provide a smooth transition in flexibility. Moreover, the
Examiner concludes that “common sense would lead one of skill in the art to
determine that the strain relief would either need to be part of the handle and
detachably coupled to the tubing or the strain relief would be part of the
flexible tubing and detachably coupled to the handle” (id.), since Fitz‟s
catheter is detachable from the handle (id.). Finally, the Examiner concludes
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“[s]ince the coupling mechanism of Fitz is a screw thread (i.e. a maze like
thread as shown in Fig. 16), it follows that the strain relief would be coupled
in the same manner and thus have a maze like thread” (id. at 5).
Appellants contend that the claims require a detachable strain relief
with a channel defining a maze-like thread (Reply Br. 4). Appellants
contend that Figure 7 of the Specification illustrates “[o]ne particular
example of a maze like thread” (id.), and shows that “the term „maze-like‟
defines a channeled structure having a more elaborate pattern tha[n] a simple
screw thread” (id.). Appellants acknowledge that Fitz discloses a coupling
spacer 70 detachably connecting the handle 20 to the outer assembly 38
(id.), but contend that Fitz‟s “simple threaded connector does not constitute a
maze-like thread” (id. at 5), nor does Holman disclose “the use of a maze-
like pattern” on its strain relief (id.).
We agree with Appellants. While it‟s true that limitations from the
Specification must not be imported into the claims, the claims must be
interpreted using “the broadest reasonable meaning of the words in their
ordinary usage as they would be understood by one of ordinary skill in the
art, taking into account whatever enlightenment by way of definitions or
otherwise that may be afforded by the written description contained in the
applicant‟s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997); see also In re Trans Texas Holdings Corp., 498 F.3d 1290, 1299
(Fed. Cir. 2007).
Figure 7 of the present Specification illustrates an example of a
“channel defining a maze-like thread” that meets the limitations of the
claims. While other complex patterns might also define maze-like threads,
the Examiner has not established that one of ordinary skill in the art would
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consider the thread on Fitz‟s coupling spacer 70 - a simple helical structure
defined by a line wound around a cylinder in a regular fashion - to define a
maze-like thread.
The evidence of record does not support the Examiner‟s finding that
one of ordinary skill in the art would consider a simple screw thread to be “a
channel defining a maze-like thread,” and the Examiner has not otherwise
explained why it would have been obvious for one of ordinary skill in the art
to replace Fitz‟s screw-type connector with the “strain relief including a
channel defining a maze-like thread” required by the claims.
SUMMARY
The rejection of claims 19, 26, and 29 under 35 U.S.C. § 103(a) as
unpatentable over Fitz and Holman is reversed;
The rejection of claims 22-25 under 35 U.S.C. § 103(a) as
unpatentable over Fitz, Holman, and Del Rio is reversed;
The rejection of claim 31 under 35 U.S.C. § 103(a) as unpatentable
over Fitz, Holman, and Randall is reversed.

REVERSED

cdc