Ex Parte Sugimoto

Board of Patent Appeals and Interferences

Sep 30, 2009

09870672 (B.P.A.I. Sep. 30, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RYOTA SUGIMOTO
__________

Appeal 2009-003720
Application 09/870,672
Technology Center 3700
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Decided: September 30, 2009
__________

Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, 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 1, 4, 5, 9-20, 22, 23, and 32-45, directed to an implantable tubular
device. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
The present invention is directed to “an implantable tubular device,
for example, a stent, having a deformable portion to improve the flexibility
of an annular unit of the device so that the device can pass easily through a
bent portion of the human body” (Spec. 2: 6-9). The deformable portion
comprises “substantially annular grooves” on the inner and/or outer surfaces
of the device that form “an endless annular configuration” or a spiral
configuration when prolonged (id. at 9: 23-27; 10: 29 to 11: 2; 12: 27).
Claim 1 is representative of the subject matter on appeal:
1. An implantable tubular device formed substantially tubular and
having a deformable portion formed on a peripheral surface thereof and
including wavy annular members with bent portions, with said deformable
portion forming a predetermined angle with respect to an axial direction of
said device and when the deformable portion is prolonged it forms an
endless annular configuration, said deformable portion being easy to deform
in comparison with a remainder part of said device, said deformable portion
being formed in a plural number, and, said deformable portions being
formed as grooves having a bottom surface provided on an inner surface of
said tubular device which faces inwardly toward an interior of said tubular
device, on an outer surface of said tubular device which faces away from the
interior of the tubular device or on both the inner and outer surfaces of said
tubular device, and the deformable portions being formed on the bent
portions of the wavy annular members such that the deformable portions are
substantially parallel with one another.

The Examiner relies on the following evidence:
Alt et al. US 5,788,979 Aug. 4, 1998
Shanley US 6,293,967 B1 Sep. 25, 2001
Palmaz WO 99/23977 May 20, 1999

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Claims 1, 4, 5, 9-13, 20, 22, 23, 32-37, and 38-43 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Shanley and Palmaz; while claims
14-19, 44, and 45 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Shanley, Palmaz, and Alt.
We reverse.
ISSUE
Claim 1 is directed to an implantable tubular device comprising wavy
annular members with bent portions, wherein the device has grooves on its
inner and/or outer surfaces, and wherein the grooves, when prolonged, form
an endless annular configuration. Independent claim 32 is similar to claim 1
but recites that the grooves form a spiral configuration.
The Examiner finds that Shanley discloses “an implantable tubular
device . . . including wavy annular members arranged in an axial direction of
the device with bent portions,” but doesn’t disclose grooves on the device
(Office Action mailed January 25, 2005, p. 2).1 However, the Examiner
finds that Palmaz teaches that “a variety of different groove patterns may be
utilized” on a similar implantable device “in order to aid in migration of
cells” (id. at p. 3), and further teaches that “the grooves may be placed
anywhere” on the device (id.). The Examiner concluded that it would have
been obvious to “provide the stent, including the annular wavy portions and
free bent portions of Shanley with grooves as taught by Palmaz in order to

1 Appellant’s Brief on Appeal refers to the Final Rejection mailed September
7, 2005 for the statement of the rejections; the Final Rejection, in turn, refers
to the Office Action mailed January 25, 2005 for the statement of the
rejections.
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aid in migration of cells” (id.), and some of the groove patterns would
inherently produce a spiral-like or annular configuration (id.).
Appellant contends that the references, whether “alone or in
combination with each other,” don’t disclose “grooves located on a bent
portion of a wavy annular member” (App. Br. 8),2 or “deformable portions
being formed as grooves and when the deformable portion is prolonged it
forms an endless annular configuration” (id. at 7) or “a spiral configuration”
(id. at 8).
In light of these conflicting positions, the issue raised by both
rejections is the same: Has the Examiner established that the combined
teachings of Shanley and Palmaz would have suggested providing grooves
on an implantable tubular device comprising wavy annular members with
bent portions, in such a way that the grooves, when prolonged, form an
endless annular configuration or a spiral configuration?
FINDINGS OF FACT
The Invention
FF1 Independent claim 1 is directed to an “implantable tubular
device . . . having a deformable portion formed on a peripheral surface
thereof and including wavy annular members with bent portions” wherein
the deformable portion is a groove “formed in a plural number” on the inner
and/or outer surfaces of the device, and wherein “when the deformable
portion is prolonged it forms an endless annular configuration” (claim 1).
Independent claim 32 is similar to claim 1, but recites that the deformable
portion, when prolonged, forms a “spiral configuration” (claim 32).

2 All references to Appellant’s Brief on Appeal are to the Substitute Brief
filed December 5, 2006.
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FF2 Figure 2 of the Specification, reproduced in part immediately
below, illustrates an embodiment of the invention that meets the limitations
of claim 1:

Figure 2 of the Specification shows a stent with “annular units 31, 32, 33,
34, 35, 36 . . . each consisting of a first wavy annular member 2a annularly
formed of a wavy element . . . [and] a second wavy annular member 2b
disposed in the axial direction of the stent 1 in such a way that the mountain
thereof is proximate to a valley of the first wavy annular member 2a and
annularly formed of a wavy element” (Spec. 5: 29 to 6: 5). “In this manner,
one annular unit is constructed” (id. at 6: 28-29).
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FF3 Figure 3 of the specification, reproduced below, is an enlarged
view of the wavy annular members and the deformable portions, i.e.,
grooves 11a, 11, shown in Figure 2:

Figure 3 shows “the deformable portion [grooves 11a, 11] . . . formed on a
bent portion of the wavy annular member” (id. at 8: 27-29). “The
deformable portion is formed in such a way that when the deformable
portion is prolonged, it continuously goes around the periphery of the
device. That is, when the deformable portion is prolonged, it forms an
endless annular configuration” (id. at 9: 20-23).
Shanley
FF4 Shanley discloses an implantable expandable medical device or
“tissue supporting device” comprising a plurality of cylindrical tubes
connected by S-shaped bridging elements (Shanley, col. 9, ll. 16-18).
FF5 Shanley’s Figure 4a, reproduced below, illustrates an axially
bendable tissue supporting device:
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Figure 4a illustrates Shanley’s “tissue supporting device 80 [which] includes
a plurality of cylindrical tubes 82 connected by S-shaped bridging elements
84 . . . [which] allow the tissue supporting device 84 to bend axially when
passing through the tortuous path of the vasculature” (Shanley, col. 9, ll. 16-
20).
FF6 Shanley doesn’t disclose grooves on the surface of the stent, for
any purpose.
Palmaz
FF7 Palmaz describes an implantable intravascular stent with “at
least one groove disposed in the inner surface of the stent” to “increase the
rate of migration of endothelial cells upon the inner surface of the stent after
it has been implanted” (Palmaz 3: 16-17, 24-25).
FF8 Palmaz’s Figure 8, reproduced below, is a plan view showing
various types of grooves provided on the inner surface of an unexpanded
intravascular stent:
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Figure 8 shows various types of grooves 400-400'''', provided on the inner
surface 301 of stent 300, “alone or in combination with each other, as
desired, to provide whatever pattern of grooves is desired, including a
symmetrical, or an asymmetrical, pattern of grooves” (Palmaz 8: 9-11).
PRINCIPLES OF LAW
When determining whether a claim is obvious, an Examiner must
make “a searching comparison of the claimed invention - including all its
limitations - with the teachings of the prior art.” In re Ochiai, 71 F.3d 1565,
1572 (Fed. Cir. 1995).
Moreover, “a patent composed of several elements is not proved
obvious merely by demonstrating that each of its elements was,
independently, known in the prior art. . . . [I]t can be important to identify a
reason that would have prompted a person of ordinary skill in the relevant
field to combine the elements in the way the claimed new invention does.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
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ANALYSIS
Shanley and Palmaz: claims 1, 4, 5, 9-13, 20, 22, 23, 32-37, and 38-43
The Examiner’s position is that it would have been obvious to put
grooves on Shanley’s device because “Palmaz teaches the desirability of
placing grooves on . . . a stent” (Ans. 6), “to aid in endothelial cell
migration” (id.). The Examiner notes that Palmaz teaches that grooves 400-
400'''', shown in Figure 8, “could be provided alone or in combination with
each other, as desired, including a symmetrical, or an asymmetrical pattern
of grooves” (id. at 4-5). The Examiner finds that “a symmetrical pattern of
grooves 400'''' would result in an endless annular configuration” (id. at 5).
Appellant contends that neither Shanley nor Palmaz “disclose[s] or
teach[es] at least the features of: 1) an implantable tubular device that has a
deformable portion formed as a groove and configured such that when it is
prolonged it forms an endless annular configuration [or a spiral
configuration]; or 2) a deformable portion formed as a groove and formed on
the bent portions of the wavy annular members” (App. Br. 10).
The Examiner is correct in that the law does not require elements of
the prior art be combined for the same reason or advantage contemplated
Appellant (see e.g., In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992), and
we agree with the Examiner that it would have been obvious to put grooves
on Shanley’s stent if only to promote endothelial cell migration.
Nevertheless, as Appellant points out, “there are many . . .
symmetrical and asymmetrical configurations for the groove[s] . . . that
would not ‘read upon’ Appellant’s claims” (Reply Br. 3). That being the
case, we disagree with the Examiner that Palmaz’s comprehensive teaching
that grooves 400-400'''' may be provided anywhere on the inner surface of
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the stent “alone or in combination with each other, as desired, to provide
whatever pattern of grooves is desired, including a symmetrical, or an
asymmetrical, pattern of grooves” (FF8) is an adequate suggestion or reason
to place the grooves in an “endless annular configuration” or a “spiral
configuration” as specifically required by the claims.
Shanley, Palmaz, and Alt: claims 14-19, 44, and 45
The Examiner rejected claims 14-19, 44, and 45 as unpatentable over
Shanley, Palmaz, and Alt. These claims depend directly or indirectly from
claim 1 and additionally require the implantable device to carry a medicine,
bioprosthetic material or a biosynthesis material.
The Examiner relies on Alt as evidence that it is conventional to coat
implantable devices like those disclosed by Shanley and Palmaz with
biologically active substances (Office Action mailed January 25, 2005, page
4).
Alt does not remedy the underlying deficiency in the Examiner’s
proposed combination of Shanley and Palmaz.
CONCLUSIONS OF LAW
The Examiner has not established that the combined teachings of
Shanley and Palmaz would have suggested providing grooves in an endless
annular configuration or a spiral configuration on an implantable tubular
device, wherein the tubular device comprises wavy annular members with
bent portions.
Comment [RML1]: KSR ?
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SUMMARY
The rejection of claims 1, 4, 5, 9-13, 20, 22, 23, 32-37, and 38-43
under 35 U.S.C. § 103(a) as unpatentable over Shanley and Palmaz is
reversed.
The rejection of claims 14-19, 44, and 45 under 35 U.S.C. § 103(a) as
unpatentable over Shanley, Palmaz, and Alt is reversed.

REVERSED

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