Ex Parte Goodin

Patent Trial and Appeal Board

Jan 27, 2015

11854894 (P.T.A.B. Jan. 27, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte RICHARD GOODIN
____________

Appeal 2012-004880
Application 11/854,894
Technology Center 3700
____________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

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

1 Appellant states that the Real Party in Interest is Boston Scientific Scimed,
Inc. (App. Br. 3.)
Appeal 2012-004880
Application 11/854,894

2
STATEMENT OF THE CASE
Claims 1–3 and 7–14 are on appeal, and can be found in the Appendix
of the Appeal Brief (App. Br. 9–10). Claim 1 is representative of the claims
on appeal, and reads as follows:
1. A balloon catheter, comprising:
an elongate shaft having a distal region defining a distal
end, a shaft lumen extending through the elongate shaft to the
distal end;
a balloon disposed about the distal region of the elongate
shaft;
a guidewire port disposed within the distal region of the
elongate shaft proximal of the balloon;
a tubular member defining a guidewire lumen disposed
within the shaft lumen, the tubular member extending from the
guidewire port to within a proximal end of a coil extending
through the balloon, the coil having a coil interior and a coil
exterior, an exterior of the tubular member being attached to the
interior of the coil; and
a polymer coating disposed on the coil interior;
wherein a distal end of the tubular member is fixedly
attached to the proximal end of the coil such that the tubular
member and the coil provide a fluid-tight passage through the
balloon.

The Examiner rejects the claims as follows:
I. claims 1–3, 7, 8, 10–12, and 14 under 35 U.S.C. § 103(a) as
unpatentable over Estrada2 in view of Barlow;3 and
II. claims 9 and 13 under 35 U.S.C. § 103(a) as unpatentable over
Estrada in view of Barlow and further in view of Speck.4

2 Edward A. Estrada et al., US 6,193,686 B1, issued Feb. 27, 2001.
3 Edward A. Barlow et al., US 5,112,304, issued May 12, 1992.
4 Marc L. Speck, US 2004/0002728 Al, published Jan. 1, 2004.
Appeal 2012-004880
Application 11/854,894

3
I. The Issue: Obviousness over Estrada and Barlow
According to the Examiner, “Estrada is relied upon for disclosing all
the structural components of the claimed balloon catheter, including a
tubular member and coil forming a secondary guidewire lumen.” (Ans. 7;
see also FF 3 below.) The Examiner acknowledges that Estrada’s “coil (42)
is disposed between layers (43 and 44) of the tube (34), [therefore,] Estrada
fails to connect the portion of the tube (34) defining the ‘tubular member’ to
the proximal end of the coil (42).” (Ans. 5; see also FF 3.) The Examiner
finds that Barlow’s catheter
[I]ncludes a coil (38) coated with a polymer (40) forming a
portion of a guidewire lumen passing through the balloon. The
guidewire lumen includes a tubular member (20) forming the
proximal portion of the guidewire lumen (22). Barlow teaches
that another way to connect a tubular member and coil to form a
fluid-tight passage for a guidewire through a balloon can be
configured so that the distal end of the tubular member is fixed
within the proximal end of the coil (location 42).
(Ans. 5; see below FF 2.) The Examiner explains that Barlow is “relied
upon for teaching an alternate way to form a fluid-tight connection between
a tubular member and coil of a guidewire lumen.” (Ans. 7; see also FF 2.)
The Examiner concludes that
It would have been obvious to one of ordinary skill in the art at
the time the invention was made to modify the connection of
the tubular member and coil of the secondary guidewire lumen
of the Estrada device so that the exterior surface of the distal
end of the tubular member is fixed within the interior of the
proximal end coil, as taught by Barlow, as this modification
merely involves the combination of known elements according
to known methods to obtain the predictable result of forming a
fluidtight guidewire lumen comprising a coil.
(Ans. 5–6.)
App
App

Exam
prov
to th
Find
(Bar
eal 2012-0
lication 11
Does the
iner’s con
ides the lim
e interior o
ings of Fa
1. Fi

FI
balloon
a proxim
inflation
tube 20
The guid
connects
structure
low, col. 3
04880
/854,894
preponde
clusion th
itation of
f the coil”
ct
g. 1 of Ba
G. 1 illust
catheter 10
al end 14
/deflation
secures int
ewire pas
between t
26
, ll. 31–54
rance of th
at the com
“an exter
?
rlow, repro
rates a per
, the prese
with guide
port 18. . .
o one end
sage 22, in
he guidew
.)
4
e evidenc
bination o
ior of the t
duced bel
spective v
nt inventi
wire entry
. The pro
of the guid
ternal to t
ire entry p
e of record
f Estrada
ubular me
ow, shows
iew of a m
on, includi
port 16 a
ximal end
ewire ent
he catheter
ort 16 and
support t
in view of
mber bein
a balloon
ultilumen
ng a hub 1
nd an
of the cat
ry port 16
tube 20,
the ballo
he
Barlow
g attached
catheter.

2 at
heter
. . . .
on

App
App

secti

(Bar
eal 2012-0
lication 11
2. Fi
on of the b
Fig. 5, re
An embe
material
such as b
tensione
the elast
spring 3
which is
elastome
which is
about po
material
heat fusi
low, col. 3
04880
/854,894
g. 5 of Ba
alloon por
produced
dded sprin
40 which
y heat fus
d to a pred
omeric ma
8 in the ela
coaxial, in
ric materi
secured a
int 58 of t
40 contain
on or adhe
, l. 59 to c
rlow, repro
tion of the
above, illu
g 38 is em
connects t
ion or adh
etermined
terial prov
stomeric m
cludes a b
al 50 and o
bout point
he embedd
ing the gu
sively.
ol. 4, l. 4;
5
duced bel
catheter:
strates the
bedded o
o the cathe
esively. T
degree pr
iding a me
aterial. A
raided fib
uter elasto
54 of the
ed spring
idewire pa
see also A
ow, shows
inflated b
r fused int
ter tube 2
he spring
ior to bein
mory for
balloon
er 48 betw
meric ma
catheter tu
38 and ela
ssage 22,
ns. 5.)
a detailed
alloon.
o elastome
0 at point
can be
g embedde
the embed
structure 2
een an inn
terial 52,
be 20 and
stomeric
such as by
cross-
ric
44,
d in
ded
6,
er

App
App

(Estr

repro
eal 2012-0
lication 11
3. Fi
Fig. 1 sh
Th
tubular m
guidewir
lumen su
the infla
extremit
extremit
extremit
compon
provides
is provid
fluorosc
ada, col. 5
4. Es
duced abo
Th
13 prefe
04880
/854,894
g. 1 of Est
ows:
e guidewi
ember 34
e 36 suita
ch as the
table ballo
y of the in
y of the ba
y of the ou
ents are pr
a flexible
ed on the
opic locati
, l. 57 to c
trada also
ve.
e inner tu
rably inclu
rada, repro
re lumen
which is
ble for adv
coronary a
on 15 is se
ner tubula
lloon is se
ter tubula
eferably b
yet sealed
exterior of
on of the b
ol. 6, l. 5;
shows a c
bular mem
des a helic
6
duced bel
18 extends
configured
ancement
rteries. . .
alingly se
r member
alingly se
r member
onded by l
bond. A
the inner
alloon du
see also A
oil within
ber 34 of
al coil 42
ow, show
through th
to slidabl
through a
. The dist
cured to th
34 and the
cured to th
33. These
aser bondi
mid-balloo
tubular me
ring the pr
ns. 5.)
the shaft,
the distal s
of high st
s a balloon
e inner
y receive
patient’s b
al extremi
e distal
proximal
e distal
catheter
ng which
n marker
mber 34 f
ocedure.
shown in F
haft sectio
rength mat
catheter.
a
ody
ty of
39
or
ig 1,
n
erial

Appeal 2012-004880
Application 11/854,894

7
and most preferably is a ribboned material. The coil 42 is
disposed between two layers of polymeric material, an inner
layer 43 and an outer layer 44. The inner layer 43 is preferably
formed of lubricous [sic] material or have a lubricious inner
surface. . . . The outer layer 44 is preferably compatible with
the material of the balloon 15 and the outer tubular member 33
so that they can be readily bonded by fusion bonding.
(Estrada col. 6, ll. 26–38.)
Principles of Law
“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).
Analysis
We adopt the fact finding and analysis of the Examiner (Ans. 4–7).
Barlow shows a tubular member defining the guidewire lumen (see element
20, FF 1–2), a coil extending through the balloon (see element 38, FF 2; see
also Ans. 5), and a polymer coating on the coil (FF 2; see also Ans. 5).
Additionally, we note that Barlow’s balloon catheter has the balloon
disposed about the distal region of the shaft (FF 1–2, see element 26), and
provides a guidewire port that is positioned at the proximal end of the shaft
and is also proximal to the balloon (FF 1, see element 16). As recognized by
the Examiner, Barlow teaches spring 38 that “is embedded or fused into
elastomeric material 40 which connects to the catheter tube 20 at point 44,
such as by heat fusion or adhesively.” (FF 2; see also Ans. 5.)
Appellant contends that the combination as proposed by the Examiner
would render Estrada’s balloon catheter unsuitable for the intended purpose,
because “the balloon will be unable to sustain an inflated condition, thereby
Appeal 2012-004880
Application 11/854,894

8
altering the principle of operation of the device and rendering it unsuitable
for its intended use.” (Br. 6–7.)
We recognize, but are not persuaded, by Appellant’s contention that
the combination of references would necessarily result in a construct that
would not function as a balloon catheter. The combination of familiar
elements does not necessarily require the wholesale substitution of entire
elements as suggested by Appellant (Br. 6–7). The obviousness inquiry does
not ask “whether the references could be physically combined but whether
the claimed inventions are rendered obvious by the teachings of the prior art
as a whole.” In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc).
Here, the Examiner is relying on Barlow “for teaching an alternate
way to form a fluid-tight connection between a tubular member and coil of a
guidewire lumen.” (Ans. 7; see also FF 2.) Estrada disclosed sandwiching a
helical coil between an outer and inner layer. (FF 4.) Estrada specifically
recognizes that “[t]he outer layer 44 is preferably compatible with the
material of . . . the outer tubular member 33 so that they can be readily
bonded by fusion bonding.” (Id.) The Examiner rejects the claims “based
on a modification attachment of the components of Estrada that form the
secondary guidewire lumen (18) in light of Barlow’s disclosure.” (Ans. 7.)
In other words, the Examiner finds it obvious to apply “an alternate way to
form a fluid-tight connection between a tubular member and coil of a
guidewire lumen. Barlow discloses that it is known to dispose the exterior
of the distal end of the tubular member within the proximal end of the coil.”
(Id.) Here, Estrada disclosed sandwiching the coil between two layers, of
which one can be bonded or fused to the outer tubular member (FF 4), while
Barlow disclosed that the coil can be either embedded or fused to the
Appeal 2012-004880
Application 11/854,894

9
material that attaches to the catheter tube (FF 2). We agree with the
Examiner’s position that one of ordinary skill in the art would recognize that
these attachment methods would be interchangeable. Accordingly, we agree
with the Examiner that taken as a whole the references suggest all the
elements as presently claimed (see FF 1–4).
Appellant’s arguments do not persuade us that the preponderance of
the evidence fails to support the Examiner’s prima facie case of obviousness.
As Appellant does not argue the claims separately, we focus our analysis on
claim 1, and claims 2, 3, 7, 8, 10–12, and 14 fall with that claim. 37 C.F.R.
§ 41.37 (c)(1).

II. The Issue: Obviousness over Estrada, Barlow and Speck
Appellant contends that Speck does not remedy the shortcomings of
Estrada and Barlow. (Br. 7.) Appellant provides no further arguments with
respect to the combination of Estrada, Barlow, and Speck; accordingly,
Appellant has waived arguments directed to this combination of references.
We therefore affirm that rejection as well. See Hyatt v. Dudas, 551 F.3d
1307, 1314 (Fed. Cir. 2008) (“In the event of such a waiver, the PTO may
affirm the rejection of the group of claims that the examiner rejected on that
ground without considering the merits of those rejections.”).

Appeal 2012-004880
Application 11/854,894

10
SUMMARY
We affirm the rejection of claims 1–3, 7, 8, 10–12, and 14 under
35 U.S.C. § 103(a) as unpatentable over Estrada and Barlow.
We affirm the rejection of claims 9 and 13 under 35 U.S.C. § 103(a)
as unpatentable over Estrada, Barlow, and Speck.

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