Ex Parte Gerberding

Board of Patent Appeals and Interferences

Mar 16, 2012

11328872 (B.P.A.I. Mar. 16, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/328,872 01/09/2006 Brent Gerberding 02-0119 (US02) 5121
41696 7590 03/16/2012
VISTA IP LAW GROUP LLP
12930 Saratoga Avenue
Suite D-2
Saratoga, CA 95070
EXAMINER
BLATT, ERIC D
ART UNIT PAPER NUMBER
3734
MAIL DATE DELIVERY MODE
03/16/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte BRENT GERBERDING
__________

Appeal 2011-000063
Application 11/328,872
Technology Center 3700
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and ERIC GRIMES,
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 80-86 and 94-98, directed to a vaso-occlusive device, and a method
of deploying the device. The Examiner has rejected the claims on the
grounds of anticipation and obviousness. We have jurisdiction under
35 U.S.C. § 6(b).
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Application 11/328,872

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STATEMENT OF THE CASE
“Vaso-occlusive devices are surgical implants placed within blood
vessels or vascular cavities, typically by the use of a catheter, to form a
thrombus and occlude the site.” (Spec. ¶ 4.) The present invention is
directed to a vaso-occlusive device that “includes one or more fold lines
along which [it] . . . may fold when it is subjected to an external force or
pressure” (id. at ¶ 13), such as contact with the wall of a body cavity (id. at
¶ 50), so that the device will conform to the shape of the cavity (id. at ¶ 11).
Claims 80-86 and 94-98 are pending and on appeal. Claims 1-79 and
87-93 have been canceled (App. Br. 3).
Claim 80 is representative of the subject matter on appeal:
80. A vaso-occlusive device comprising:
an elongate vaso-occlusive member having a relaxed configuration in
the shape of a helical coil and having one or more key-ways along said
helical coil configured to form one or more fold lines on the vaso-occlusive
member; wherein
said vaso-occlusive member folds into a desired folded configuration
when one or more portions of the vaso-occlusive device bear against one or
more walls of a body cavity.
Claims 80-83, 86-90, 93-96, and 98 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Ritchart (US 4,994,069, issued Feb. 19, 1991).
Claims 85 and 92 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Ritchart and Porter (US 2002/0193819 A1, published
December 19, 2002).
Claims 84, 91, and 97 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Ritchart and Engelson (US 5,599,492, issued February 4,
1997).
We reverse.
Appeal 2011-000063
Application 11/328,872

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FINDINGS OF FACT
1. Claim 80 is directed, in relevant part, to a vaso-occlusive device
comprising an elongate member with a relaxed configuration in the shape of
a helical coil, with one or more key-ways along the helical coil configured to
form one or more fold lines when the device bears against the walls of a
body cavity.
2. Figure 1 of the Specification, reproduced below, depicts a vaso-
occlusive device 10(1) that has a linear configuration in its relaxed state:

Figure 1 of the Specification depicts a vaso-occlusive device 10(1)
that has a linear configuration in its relaxed state. Figure 1 also shows a
key-way 14a, “which takes the form of a pitched slot or groove that is
created along a portion of vaso-occlusive member 12” (Spec. ¶ 60), and
“two possible fold lines 15a and 15b, along which the vaso-occlusive
member 12 could fold” (id. at ¶ 61) “when the vaso-occlusive member 12 is
subjected to an external force” (id.).
3. According to the Specification, “key-way(s) can be formed on
the member using a variety of means, including laser-etching, mechanical
removal of a portion of the vaso-occlusive member, and injection molding”
(Spec. ¶ 13). The purpose of the key-ways is to “weaken the axial and
flexural strength of the member . . . and cause[ ] the vaso-occlusive member
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12 to be more susceptible to being folded along a fold line in a certain
direction when the device 10 is subjected to an external force” (Spec. ¶ 50).
4. Figure 2 of the Specification, reproduced below, shows the
vaso-occlusive member 12 in cross-section, and also shows several possible
shapes for the key-way: rectangular, triangular, and trapezoidal (Spec. ¶¶ 22,
63):

Figure 2 of the Specification shows the vaso-occlusive member 12 in
cross-section, and also shows several variations of the key-way. The
Specification teaches that the key ways “may have any suitable cross-
section, e.g., rectangular or triangular” and the “widths and depths of the
key-way(s) can vary to . . . promote specific fold lines along the length of
the vaso-occlusive member” (id. at ¶ 14).
5. Figure 18, reproduced below, depicts the vaso-occlusive device
entering a body cavity through a delivery catheter and folding along its key-
ways as it comes in contact with the wall of the body cavity (Spec. ¶ 85):

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Figure 18 depicts the vaso-occlusive device 10 entering a body cavity
401 through a delivery catheter and folding along key-ways 14 as it comes in
contact with the wall of the body cavity. “[T]he folding pattern . . . is
promoted by the key-way(s) 14, which weaken the axial . . . and flexural
strength of the vaso-occlusive device 10 and produce one or more preferred
fold lines in the device” (id.). Thus, the device “should assume a three
dimensional configuration within the body cavity” (id.).
6. Figure 10A of the Specification, reproduced below, depicts a
vaso-occlusive device with a secondary shape, i.e., a relaxed configuration
in the shape of a helical coil, as required by the claims on appeal (Spec. ¶
75):

Figure 10A depicts a vaso-occlusive device with a secondary shape, in
this case a relaxed configuration in the shape of a helical coil. “The shape of
the secondary . . . relaxed configuration . . . help[s] fill up the body cavity”
and “the key-ways along portions of the vaso-occlusive member 12 allow
the vaso-occlusive device to fold when portions of the . . . device encounter
the walls of the body cavity 401 or other object” (id. at ¶ 86).
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7. Ritchart discloses a vaso-occlusive device that has “a stretched,
linear condition in which it can be advanced through a catheter lumen . . .
and a relaxed, convoluted condition produced by a combination of a helical
winding of the wire, and irregularities of the helical winding” (Ritchart,
Abstract). “When the wire is released from a catheter into a vessel, it
assumes a randomly coiled, substantially space-filling mass which is lodged
at the site of release” (id.).
8. The steps in the construction of Ritchart’s vaso-occlusive wire
14 are depicted in Figures 2A-2C, reproduced below:

Figures 2A-2C illustrate the steps in the construction of Ritchart’s
vaso-occlusive wire 14. “The wire itself is formed by wrappings or
windings of a fine wire thread 18 . . . on a spinning mandrel . . . to produce a
single-layer coil with a minimum helical pitch, i.e., in which the windings
are close packed” as shown in Figure 2A (Ritchart, col. 4, ll. 45-56). Next,
as shown in Figure 2B, “[t]he coiled wire is wound on a larger-diameter
mandrel to form a helical winding 20 whose helix diameter . . . 22, is
approximately that of the vessel for which the coil is intended” (id. at col. 4,
ll. 65-68). Finally, as illustrated in Figure 2C, “the wire is further preformed
to contain irregularities in the helical winding, such that the wire adopts a
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Application 11/328,872

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folded, convoluted conformation in a relaxed condition,” preferably “by
deforming, as by twisting, the wire in the region of desired bends” and heat
treating for memory retention (id. at col. 5, ll. 11-21).
9. According to Ritchart, “[t]he wire just described . . . [has] a
primary structure formed by the coil wrapping making up the wire, a
secondary structure formed by the helical winding, and a tertiary structure
formed by the irregularities in the winding” (Ritchart, col. 5, ll. 35-39).
10. Ritchart discloses an alternative “flattened coil embodiment”
(Ritchart, col. 5, ll. 57-58), in which “the irregularities in the helical winding
are produced by flattening the wire coil in different directions . . . for
example, by squeezing the coil wire at several regions along the winding,
such as region 32 . . . at different angles with respect to the wire axis” (id. at
col. 5, ll. 46-51). Figure 3A shows the device in its stretched, linear
condition, and Figure 3B shows the same device in its relaxed condition.
Figures 3A and 3B are reproduced below:

Figures 3A and 3B of Ritchart illustrate “irregularities in the helical
winding . . . produced by flattening the wire coil in different directions . . .
for example, by squeezing the coil wire at several regions along the winding
. . . at different angles with respect to the wire axis” (id.). Figure 3A shows
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the device in its stretched, linear condition, and Figure 3B shows the same
device in its relaxed condition.
DISCUSSION
There are three rejections of the claims on the grounds of anticipation
and obviousness, but the dispositive issue in each is whether the evidence of
record supports the Examiner’s finding that Ritchart’s device has the “key-
way(s)” required by all the claims on appeal.
The Examiner finds that Ritchart’s vaso-occlusive device comprises
“an elongate vaso-occlusive member figure having a secondary relaxed
configuration in the shape of a helical coil . . . and having one or more
irregularities along the helical coil configured to form one or more fold lines
on the vaso-occlusive member” (Ans. 3). According to the Examiner, the
irregularities are “thinned” or “flattened” portions, formed “by squeezing the
coil wire at several regions” (id. at 6), and “are considered to comprise key-
ways” (id. at 3-4). That is, the Examiner finds that Ritchart “intends that the
wire itself – not the ‘coil shape’ – is formed by this squeezing process to
produce the flattened portions 32 shown in Figure 3A” (id. at 6).
Appellant disagrees with the Examiner’s reading of Ritchart, and
contends that Ritchart “teaches a device having a helical coil in which the
coils are flattened in different directions to create a different shape in the
relaxed condition” (id. at 6), rather than a device with “the claimed key-
ways along the helical coil” (id. at 5).
We agree with Appellant that the evidence of record does not support
the Examiner’s finding that the flattened portions of Ritchart’s device are
key-ways. The present Specification teaches generally that a key-way
involves removal or omission of a portion of the vaso-occlusive member in
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Application 11/328,872

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order to “weaken the axial and flexural strength of the member . . . and
cause[ ] the vaso-occlusive member 12 to be more susceptible to being
folded along a fold line in a certain direction when the device 10 is subjected
to an external force” (FFs 3, 4). In other words, the key-way modifies the
cross-section of the primary structural element of the claimed device, i.e.,
the un-coiled wire, and is independent of any secondary structure (FF6).
Ritchart, on the other hand, introduces “irregularities,” such as
flattened regions, into a preformed coil. First, fine wire thread is wound
around a small mandrel to produce a single-layer coil with a minimum
helical pitch (as shown in Figure 2A of Ritchart). Next, “[t]he coiled wire is
wound on a larger-diameter mandrel to form a helical winding” as shown in
Figure 2B. Only then are irregularities (e.g., flattened regions) introduced in
the helical winding, “such that the wire adopts a folded, convoluted
conformation in a relaxed condition” (FFs 8-10). Thus, we agree with
Appellant that Ritchart discloses “a device having a helical coil in which the
coils are flattened in different directions to create a different shape in the
relaxed condition” (App. Br. 6), and does not disclose a device in which
“portions of the wire itself are flattened” (id.).
In any case, the claims require a device with at least one key-way and
a relaxed configuration in the shape of a helical coil. In contrast, once
flattened regions are introduced into Ritchart’s helical winding (i.e., helical
coil), it takes on a new, convoluted shape in its relaxed condition, rather than
relaxing into the shape of a helical coil (FFs 8-10). As Ritchart explains, the
“relaxed, convoluted condition [shown in Figures 2C and 3B is] produced by
a combination of a helical winding of the wire, and irregularities of the
helical winding” (FF7).
Appeal 2011-000063
Application 11/328,872

10
SUMMARY
The rejection of claims 80-83, 86-90, 93-96, and 98 under 35 U.S.C.
§ 102(b) as anticipated by Ritchart is reversed.
The rejection of claims 85 and 92 under 35 U.S.C. § 103(a) as
unpatentable over Ritchart and Porter is reversed.
The rejection of claims 84, 91, and 97 under 35 U.S.C. § 103(a) as
unpatentable over Ritchart and Engelson is reversed.

REVERSED

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