Ex Parte Osborne et al

Patent Trial and Appeal Board

Jan 14, 2015

11714579 (P.T.A.B. Jan. 14, 2015)

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.
11/714,579 03/06/2007 Thomas A. Osborne 8627-1668 4114
48004 7590 01/14/2015
BGL/Cook - Indianapolis
BRINKS GILSON & LIONE
CAPITAL CENTER, SUITE 1100
201 NORTH ILLINOIS STREET
INDIANAPOLIS, IN 46204-4220
EXAMINER
SZPIRA, JULIE ANN
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
01/14/2015 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 THOMAS A. OSBORNE and M. KEM HAWKINS
__________

Appeal 2012–006981
Application 11/714,579
Technology Center 3700
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
puncture resistant balloon catheter. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellants identify the Real Party in Interest as Cook Medical
Technologies LLC (see App. Br. 2).
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Statement of the Case
Background
“Conventional balloon catheters may be used to maneuver through the
fenestration of the stent graft and deploy a stent. However, conventional
balloon catheters are prone to puncture during the delivery and deployment
of the stent” (Spec. 1 ¶ 5).
The Claims
Claims 1–4, 6–12, and 15 are on appeal. Independent claim 1 is
representative and reads as follows:
1. A puncture resistant balloon catheter comprising:
a catheter comprising a shaft extending along a
longitudinal axis of the catheter and an inflation lumen
extending therethrough;
a balloon formed from a polymeric material overlying
the shaft of the catheter, the inflation lumen being in
communication with the balloon to inflate the balloon;
and a puncture resistant cover disposed over the
balloon, the cover made of a metallic alloy having a
thickness ranging from about 0.0001 inches to about 0.0020
inches and having a width extending along a working length
of the balloon, the width being less than the working length
and ranging from about 0.010 inches to about 0.040 inches,
the cover extending circumferentially around the balloon
along the working length thereof and covering substantially
the entire outer surface of the balloon over the working
length, the cover being fitted to a size and shape of an
expanded state of the balloon and being adapted to be
movable between a deflated state and an inflated state in
response to inflation of the balloon, wherein the cover
inhibits piercing of the balloon.

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The issue
The Examiner rejected claims 1–4, 6–12, and 15 under 35 U.S.C.
§ 103(a) as obvious over Trotta2 and Andrews3 (Ans. 5–7).
The Examiner finds that Trotta teaches “a puncture resistant balloon
catheter comprising: a catheter (17) . . . a balloon (10) formed from a
polymeric material . . . and a puncture resistant cover (20) disposed over the
balloon, having a thickness ranging from about 0.0001 inches to about
0.0020 inches” (Ans. 5). The Examiner finds that Trotta teaches “the cover
being fitted to a size and shape of an expanded state of the balloon and being
adapted to be movable between a deflated state and an inflated state in
response to inflation of the balloon, wherein the cover inhibits piercing of
the balloon” (Ans. 5).
The Examiner acknowledges that Trotta “fails to disclose the cover
being made of a metallic alloy and having a width of about .010 to .040
inches” (Ans. 6).
The Examiner finds that Andrews teaches “a cover made from a
metallic alloy . . . disposed over the surface of a balloon . . . where the cover
is . . . a sleeve” (Ans. 6). The Examiner finds it obvious to “reinforce the
polymeric balloon of Trotta et al. with a metallic alloy cover, in view of the
teachings of Andrews et al., to prevent axial movement and wall thinning of
the balloon . . . which would prevent accidental puncture of the balloon”
(Ans. 6).

2 Trotta et al., US 5,613,979, issued Mar. 25, 1997.
3 Andrews et al., US 6,156,254, issued Dec. 5, 2000.
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Trotta and Andrews render the
claims obvious?
Findings of Fact
1. Figure 1 of Trotta is reproduced below:

“FIG. 1 is an enlarged, fragmentary view, taken partly in longitudinal
section, of the distal end of a balloon catheter” (Trotta, col. 3, ll. 59–61).
2. Trotta teaches that a “difficulty which is found with such
biaxially oriented balloons is that, since they are typically very thin–walled,
they can be easily punctured” (Trotta, col. 1, ll. 26–28).
3. Trotta teaches a solution is where “the inflatable balloon has an
outer surface which is surrounded by an elastomeric sleeve. The sleeve is
bonded typically throughout at least a majority of its area to the balloon
outer surface, to provide pin hole and abrasion resistance” (Trotta, col. 1, ll.
59–63).
4. Trotta teaches that “[o]uter polyurethane layer may 20 have a
thickness of, typically, 0.0005 to 0.002 inch, to provide abrasion and
puncture resistance to the coextruded tubular structure 22 which comprises
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PET balloon 10 and polyurethane outer tubular layer 20” (Trotta, col. 4, ll.
33–37).
5. Trotta teaches that the “balloon catheter of this invention may
carry an expansible stent about the outer surface of the elastomeric sleeve, so
that the expansible stent may be expanded by the balloon into engagement
with the wall of a blood vessel” (Trotta, col. 3, ll. 7–10).
6. Andrews teaches “the stent readily punctures the balloon before
the stent can be properly placed. It is common to use two or three balloons
to place the stent. The use of replacement balloons increases the time of the
procedure during which time the arterial blood flow is restricted, thus
increasing patient risk and trauma” (Andrews, col. 2, ll. 43–49).
7. Andrews teaches that the “fibre re–inforcement is formed
integrally with the material of the wall of the balloon portion so that it
moves with the wall as the balloon portion is inflated” (Andrews, col. 3, ll.
32–34).
8. Andrews teaches that “[h]owever, the fibres could be at an
inner or an outer surface of the flexible wall material, as long as they are in
some way bonded or affixed to the wall material so that they are
substantially fixed with respect to the wall material and do not slide or move
significantly with respect to the wall material” (Andrews, col. 3, ll. 37–42).
9. Andrews teaches that the “braiding can be made from any
suitable material, notably a stainless steel or polymer fibre, ribbon or wire.
Preferably, the material is one which possesses shape memory properties”
(Andrews, col. 4, ll. 16–19).
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10. Andrews teaches that materials may include “medical grade
stainless steel and polymers such as polyesters, notably PET or polyamides,
for example those materials available under the Trade Mark Nitinol”
(Andres, col. 4, ll. 40–43).
11. Andrews teaches that “the reinforcement may be configured so
that limited radial stretching of the balloon may occur so that the
reinforcement constructed from the inelastic fibres need not itself be
inelastic” (Andrews, col. 3, ll. 50–54).
Principles of Law
“An examiner bears the initial burden of presenting a prima facie case
of obviousness.” In re Huai–Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417. “A person of ordinary skill is also a person of
ordinary creativity, not an automaton.” Id. at 421.
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 5–10; FF 1–10) and agree that claim
1 is obvious over Trotta and Andrews. We address Appellants’ arguments
below.
Appellants contend that “the properties of Trotta’s elastomeric sleeve
are opposite of the properties of Applicants’ cover or coil, which is required
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to be metallic, and therefore, would be hard and have limited elasticity
compared to Trotta’s elastomeric sleeve” (App. Br. 5).
We find these arguments unpersuasive. Appellants fail to address the
combination of Trotta and Andrews, instead arguing the references
individually. Trotta teaches the problem of balloon punctures (FF 2) and a
solution relying upon the use of elastomeric balloon cover (FF 3). Andrews
also recognizes the puncture problem (FF 6), and suggests the use of metal
braiding (FF 9) which may be located at “an outer surface of the flexible
wall material, as long as they are in some way bonded or affixed to the wall
material” (Andrews, col. 3, ll. 37–39; FF 8). We agree with the Examiner
that “the substitution of the metal reinforcement of Andrews for the
elastomeric reinforcement of Trotta is an obvious variation of a secondary
structure designed to support a catheter balloon and prevent that balloon
from being accidentally puncture” (Ans. 8).
Appellants contend that “Andrews fails to fill the deficiencies of
Trotta. Andrews discloses a fibre braiding reinforcement in a balloon”
(App. Br. 5). Appellants contend that “Andrews only relates to a reinforcing
structure” (Reply Br. 4).
We are not persuaded because Andrews teaches both fibre braiding
“formed integrally with the material of the wall of the balloon” as well as
teaching that “the fibres could be at an . . . outer surface of the flexible wall
material” (Andrews, col. 3, ll. 32–42; FF 7–8). This is consistent with the
Examiner’s finding that “Andrews distinctly points out that the support
structure can be overlaid on the balloon, as long as there is a means to
adhere the support structure and the balloon to one another” (Ans. 9). We
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agree with the Examiner that Andrews is reasonably interpreted as
suggesting placement of the fibre reinforcement over the balloon, not just
inside the material of the balloon, which is also consistent with the covering
sleeve of Trotta (FF 3).
Appellants contend that “Andrews fails to disclose that the fibre
reinforcement covers substantially the entire working length of the balloon”
(App. Br. 5–6).
We are not persuaded. As the Examiner notes and Appellants do not
dispute, “Trotta discloses that the puncture resistant cover extends over the
entire working length of the balloon” (Ans. 5, 9). Because the problem that
both Trotta and Andrews address is the concern regarding punctures of the
balloon during treatment (FF 2, 6), the ordinary artisan would have
reasonably found it obvious to cover the entire working length of the balloon
with the puncture resistant cover in order to prevent the undesirable
punctures at an uncovered location, as Trotta teaches that the “balloon has an
outer surface which is surrounded by an elastomeric sleeve” (Trotta, col. 1,
ll. 59–61; FF 3).
Appellants contend that “Trotta and the claimed inventions are
directly opposite of each other: Trotta is fitted to the deflated state, and the
claimed inventions are fitted to the expanded state” (Reply Br. 3).
Appellants contend that “Applicants’ cover does not merely contract and
expand with the balloon, it is ‘fitted’ to the balloon in its ‘expanded state’”
(Reply Br. 2).
We do not find these arguments persuasive. Just as claim 1 requires a
cover “adapted to be movable between a deflated state and an inflated state
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in response to inflation of the balloon”, Trotta also teaches that the sleeve
may move between a deflated and inflated state (FF 5). Similarly, Andrews
teaches that “the reinforcement may be configured so that limited radial
stretching of the balloon may occur so that the reinforcement constructed
from the inelastic fibres need not itself be inelastic” (Andrews, col. 3, ll. 50–
54; FF 11). Thus, Andrews also teaches that the cover may be “adapted to
be movable between a deflated state and an inflated state in response to
inflation of the balloon” as required by claim 1.
To the extent that Appellants are interpreting the claim limitation of
“cover being fitted to a size and shape of an expanded state of the balloon”
as a structural limitation, rather than an intended use recitation for the cover,
after the Andrews cover composed of braided stainless steel (FF 9) has been
expanded, the Andrews cover would reasonably render this structural
limitation obvious when combined with Trotta.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that Trotta
and Andrews render the claims obvious.

SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as being obvious over Trotta and Andrews. Pursuant to 37 C.F.R.
§ 41.37(c), claims 2–4, 6–12, and 15 fall with claim 1, as these claims were
not argued separately.
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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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