Ex Parte Cheves et al

Patent Trial and Appeal Board

Jun 7, 2013

10828699 (P.T.A.B. Jun. 7, 2013)

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.
10/828,699 04/21/2004 Karen M. Cheves 1001.1705101 5388
11050 7590 06/07/2013
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
GILBERT, ANDREW M
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
06/07/2013 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 KAREN M. CHEVES, LOREN M. CROW,
GREGORY S. KELLEY, STEVEN A. McAULEY,
HERBERT R. RADISCH, JR., RICARDO DAVID ROMAN,
and SHOW-MEAN WU,
____________

Appeal 2011-010877
Application 10/828,699
Technology Center 3700
____________

Before MELANIE L. McCOLLUM, ULRIKE W. JENKS, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal
1
under 35 U.S.C. § 134 involving claims directed to
a cutting balloon catheter having a blade that undulates from side-to-side in
the longitudinal direction. The Examiner has rejected the claims as
anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1
Appellants state that the Real Party-In-Interest is Boston Scientific SciMed,
Inc. (App. Br. 3.)
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Application 10/828,699

2
STATEMENT OF THE CASE
Claims 15 and 26-33 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief (App. Br. 11-13). Claim 15 is the sole
independent claim and representative of the claims on appeal, and reads as
follows:
15. A cutting balloon catheter, comprising:
an elongate catheter shaft;
a balloon coupled to the shaft, the balloon having a first fully
inflated configuration and a second non-inflated configuration,
wherein the balloon has a plurality of substantially smooth wings
formed therein when in the second non-inflated configuration;
a metallic cutting blade for severing or breaking up a lesion
adhesively bonded to the balloon throughout the entire use of the
cutting balloon catheter, the cutting blade including means for cutting
having two intersecting planes which form a cutting edge, including
means for gripping thereon, having a longitudinal axis, and having a
crosssectional shape that is substantially triangular in a plane
transverse to the longitudinal axis;
wherein the means for cutting and means for gripping are
defined by a series of undulations on the cutting blade in the first fully
inflated configuration; and
wherein the undulations curve from side-to-side relative to the
longitudinal axis in the first fully inflated configuration.
The following ground of rejection is before us for review:
The Examiner has rejected claims 15 and 26-33 under 35 U.S.C.
§ 102(e) as unpatentable over Wu.
2

As Appellants do not argue the claims separately (Ans. 9), we focus
our analysis on claim 15, and claims 26-33 stand or fall with that claim.
37 C.F.R. § 41.37 (c)(1)(vii).

2
Show-Mean Steve Wu et al., US 2004/0243156 Al, published Dec. 2,
2004.
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3
The Issue
The Examiner takes the position that Wu disclosed a cutting balloon
catheter with a cutting blade. (Ans. 4-5.) The Examiner finds, and
Appellants do not contest, that the blade on the balloon catheter in the
deflated state undulates from side-to-side along the longitudinal axis.
(Ans. 4-5; App. Br. 6.)
Appellants, however, assert that
Wu is silent regarding any undulations of the blades when the
balloon is inflated. Appellants note that it is likely that in the
inflated state, the cutting members would extend longitudinally
along a straight path, without any undulation, as there would be
no wings 42, and thus no undulating surface 44 that the cutting
members would match.
(App. Br. 6.)
The issue is: Does an undulating knife-like blade on a cutting balloon
catheter in the deflated position become straight when the balloon is
inflated?

Findings of Fact
FF 1. The Examiner‟s Answer and responses to Appellants arguments
are hereby incorporated by reference (Ans. 3-14).
FF 2. Wu disclosed a cutting balloon catheter, Figure 2 showing such
a catheter is reproduced below:
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“FIG. 2 is a perspective view of a balloon catheter that is deflated to
illustrate a plurality of wings in the balloon.” (Wu, 1 ¶ 0009; Ans. 4-5.)
FF 3. Figure 3 of Wu is reproduced below:

“FIG. 3 is a cross-sectional view taken along line 3-3 in FIG. 2.” (Wu, 1
¶ 0010; Ans. 4, 7.)
FF 4. Figure 4 of Wu is reproduced below:

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“FIG. 4 is an alternative cross-sectional view of the balloon when inflated”
(Wu, 1 ¶0011; Ans. 4, 7)
FF 5. Wu disclosed “[c]utting members 16 may be a blade or other
structure configured for cutting into tissue such as a lesion. For example,
cutting members 16 may include a metallic cutting blade that is similar to a
knife.” (Wu, 2 ¶0018; Ans. 4.)

Principles of Law
A prima facie case can be rebutted by evidence showing that the prior
art products do not necessarily possess the characteristics of the claimed
product. In re Best, 562 F.2d 1252 1255 (CCPA). See also Titanium Metals
Corp. v. Banner, 778 F.2d 775 (Fed. Cir. 1985).

Analysis
Appellants assert that the Examiner admitted that Wu does not teach
every element of claim 15 (App. Br. 5-6, Reply, Br. 3). The Examiner
contends that the statement “„Wu is silent regarding any undulations of the
blades when the balloon is inflated‟ was made in reference to the §103(a)
rejection and not the §102(e) rejection” and that this statement is not an
admission with respect to Wu‟s blade structure in the inflated state (Ans. 5).
We agree with the Examiner‟s position that making a statement of fact
recognizing that a reference does not use words to describe a particular
feature does not mean that the feature is not inherently present in the
reference.
Both the Examiner (id. at 4-5 and 8) and Appellants (App. Br. 6)
agree that, in the deflated position, blade 16 has an undulating structure
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6
running along the longitudinal length of the catheter (FF 2). Indeed,
Appellants acknowledge that “Wu shows the wings and blades appearing to
have side-to-side undulations when the balloon is in its deflated state.”
(App. Br. 6.)
Appellants contend, however, the Examiner‟s position that “[a]
metallic cutting blade that is similar to a knife configured to cut into tissue is
necessarily and inherently rigid to retain the blade‟s undulating structure
between the deflated and inflated position.” (Ans. 9.) Rather, Appellants
contend that:
Wu appears to show that the undulations of the wings disappear
when the balloon is inflated. . . . Appellants note that it is likely
that in the inflated state, the cutting members would extend
longitudinally along a straight path, without any undulation, as
there would be no wings 42, and thus no undulating surface 44
that the cutting members would match.
(App. Br. 6.)
We are not persuaded. As recognized by the Examiner, Wu disclosed
that “[t]he „cutting members 16 may include a metallic cutting blade that is
similar to a knife.‟” (Ans. 9; FF 5.) Thus, while the balloon is made of
flexible and pliable material, “the cutting members are a rigid blade structure
configured for cutting into tissue, such as a lesion” (Ans. 6, citing Wu at
¶18).
Appellants assert that “the Examiner appears to rely on „expectation‟
of the rigidity of Wu‟s blade to conclude that the undulations would remain
when the balloon is inflated.” (App. Br. 6-7.) Appellants contend that the
knife-like structures are made of material that can bend or flex. To support
their position, Appellants provide a teaching reference that illustrates
“cutting member 20 may be securely coupled to balloon 16 while still being
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able to move laterally about eight degrees or less. Additionally, different
portions of cutting member 20 may be able to bend or flex, while other
portions remain essentially unchanged.” (App. Br. 7 citing Gregory S.
Kelley, US 2005/0228343 Al, published Oct. 13, 2005, ¶ 0022; see also
Reply Br. 4.)
We find the Examiner has the better position. We agree with the
Examiner‟s finding that “[o]ne of ordinary skill in the art at the time of the
invention would recognize that in the inflated configuration the cutting blade
(16) would retain undulations if it was to be configured for cutting into
tissue as a metallic cutting blade that is similar to a knife” (Ans. 9). The
Examiner finds that:
There is no evidence disclosed in Kelly that the cutting member
(20) itself flexes. No, what Kelly teaches is that the joining
member (38) provides a flexible and bendable connection
between the cutting member and the balloon. Additionally, Wu
does not use or require a joining member. Instead, Wu uses an
adhesive to attach the blade to the balloon. Thus, Kelly teaches
flexibility and bending of a blade via a joining member that
attaches the blade to the balloon; whereas Wu explicitly
discloses a metallic, knife-like rigid blade attached directly to
the balloon via adhesive.
(Id. at 13.) What is missing from Appellants‟ reliance on Kelly, and from
the evidence of record as a whole, is any showing that the bending and
flexing of the blade material would necessarily cause the cutting member to
straighten from an undulating state to a state of zero undulations when the
balloon becomes inflated.
Additionally, while some portions of the cutting member in Kelley
may bend and flex other portions according to Kelley remain unchanged
(App. Br. 7). As there no indication in the claim with regards to the quantity
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or amount of undulations that are needed to meet this limitation, any
unchanged portion in the blade would thereby meet the claim limitation.
Here, Appellants have not met the burden of showing that the prior art
product does not necessarily possess the characteristic undulations when in
the inflated state. In re Spada, 911 F.2d 705, 709 (Fed. Cir.1990).
We are also not persuaded by Appellants‟ reliance on Figures 3 and 4.
Figures 3 and 4 of Wu show a cross-section taken through the catheter at a
single point along the longitudinal length (FFs 2-3). As such, all that is seen
is what the structure of the balloon catheter looks like at that particular point
when the catheter in either in a deflated or inflated position (Ans. 6-7).
When the balloon is inflated, as shown in Figure 4, the only structures that
appear to change in a comparison of Figure 3 and 4 are the pliable and
flexible wings, while the shape of blade 16 in these figures does not change
(Ans. 6-7; FF 3).
We conclude that the preponderance of the evidence of record
supports the Examiner‟s conclusion that Wu anticipates claim 15. We thus
affirm the rejection of claim 15 under 35 U.S.C. § 102(e) as anticipating, as
claims 26-33 fall with that claim, we affirm the rejection as to those claims
as well. 37 C.F.R. § 41.37(c)(1)(vii).

SUMMARY
We affirm the rejection of claims 15 and 26-33 under 35 U.S.C.
§ 102(e) as unpatentable over Wu.

Appeal 2011-010877
Application 10/828,699

9
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

cdc