Ex Parte 5501759 et al

Board of Patent Appeals and Interferences

Aug 12, 2011

90008638 (B.P.A.I. Aug. 12, 2011)

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.
90/008,638 05/15/2007 5501759 1001.1594103 3376
28075 7590 08/12/2011
SEAGER, TUFTE & WICKHEM, LLC
1221 NICOLLET AVENUE
SUITE 800
MINNEAPOLIS, MN 55403-2420
EXAMINER
DIAMOND, ALAN D
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
08/12/2011 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 SCHNEIDER (USA), INC.
Appellant
____________

Appeal 2011-004007
Reexamination Control 90/008,638
Patent 5,501,759
Technology Center 3900
____________

Before RICHARD TORCZON, ROMULO H. DELMENDO, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

DELMENDO, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2011-004007
Reexamination Control 90/008,638
Patent 5,501,759

2
Schneider (USA), Inc.,1 the record owner of United States Patent
5,501,759 (hereinafter the “‘759 Patent”), appeals under 35 U.S.C. §§ 134(b)
and 306 from a final rejection of claims 1-33 (Amended Appeal Brief filed
April 12, 2010, hereinafter “App. Br.,” at 4-5; Final Office Action mailed
July 16, 2009).2 We have jurisdiction under 35 U.S.C. §§ 134(b) and 306.
We AFFIRM.

STATEMENT OF THE CASE
This proceeding was initiated based on a third-party request for ex
parte reexamination filed by Cordis Corporation (represented by Woodcock
Washburn LLP, Philadelphia, PA) on May 15, 2007, which was granted on
June 29, 2007.
We have been informed that the ‘759 Patent has been asserted against
various entities including the Requester in a civil action captioned Boston
Scientific Corp. et al. v. Johnson & Johnson et al., No. C 02-cv-00790 (N.D.
Cal.) (App. Br. 4). We have also been informed that the parties have since
settled, resulting in a dismissal with prejudice on October 14, 2009 (App. Br.

1 According to the Patent Owner’s Appeal Brief, the real party in interest is
Boston Scientific Scimed, Inc., formerly Schneider (USA) Inc. (App. Br. 4).
The assignment of record, however, does not reflect this change in name
(Patent Assignment Abstract of Title entered on May 18, 2007; Reel
006733/Frame 0862).
2 The ‘759 Patent, which names Michael R. Forman as sole inventor, issued
on March 26, 1996. The ‘759 Patent claims benefit of an earlier filing date
as a continuation of Application 08/113,181 filed August 30, 1993 (now
abandoned), which in turn is a divisional of Application 07/800,201 filed
November 29, 1991, which is now United States Patent 5,267,959 issued to
Forman on December 7, 1993.
App
Reex
Paten

4). O
21, 2
affec
form
dilat
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ener
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refer
HYT
high
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form
of w
below
eal 2011-0
amination
t 5,501,75
ther than
007, we h
t our decis
The ‘759
ing consis
ation ballo
ess in whic
gy having
meric dilat
red to as P
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length ban
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ing the dil
avelengths
For illus
:
04007
Control 9
9
an Order o
ave not be
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Patent sta
tent and re
ons (col. 4
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ty wavelen
ds of the
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atation me
(claim 1;
trative pur
0/008,638
n Motion
en made a
12-13).
tes that th
liable fusi
, ll. 1-3).
romatic en
gth of 10.6
ber (e.g.,
polymeric
on-unifor
gth bands
polymeric
ity wavele
mber over
col. 3, l. 3
poses, Fig

3
s for Summ
ware of an
e inventio
on bonds b
Specifical
ergy of a
microme
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body (e.g
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and at lea
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lapping on
9 to col. 4
ure 1 of th
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etween ca
ly, the ‘75
selected w
ters) is use
ne terepht
., a polyes
bsorption
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orming the
s of the po
e another
, l. 9).
e ‘759 Pat
ent dated
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a process
theters an
9 Patent c
avelength
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ter such a
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ent is repr

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hat may
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s
at include
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aterial
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oduced
r

App
Reex
Paten

Figu
of a
cathe
terep
as H
ballo
Figu
eal 2011-0
amination
t 5,501,75
re 1 of the
balloon ca
ter 16 inc
hthalate) s
YTREL) (
Figure 2
on cathete
re 2 above
Claims 1
1.
polymer
the body
po
along an
material
a first su
surface p
relation,
the dilat
04007
Control 9
9
‘759 Pate
theter 16 m
luding a di
urroundin
col. 4, ll. 1
of the ‘75
r 16 of Fig
shows, in
-5, 7, 8, a
A proces
ic body an
, comprisi
sitioning
d in surrou
, with the d
rface porti
ortion of
wherein th
ation mem
0/008,638
nt above d
ade in ac
latation ba
g a cathete
6-18, 40-5
9 Patent is
ure 1 and
ter alia, fu
nd 15 on a
s for formi
d a polym
ng the step
a dilatation
nding rela
ilatation m
on of the d
the body in
e polyme
ber have n

4
epicts a si
cordance w
lloon 20 (
r tubing 1
3; col. 5,
an enlarg
is reprodu
sion bond
ppeal read
ng a fluid
eric dilatat
s of:
member
tion to a b
ember an
ilatation m
a contigu
ric materia
on-uniform
de view of
ith the in
e.g., polye
8 (preferab
ll. 15-22).
ement of a
ced below
36 (col. 5,
as follow
tight seal
ion memb
of polyme
ody of po
d body ali
ember an
ous and c
ls forming
energy a
the distal
vention, th
thylene
ly a polye
portion o
:

ll. 27-36)
s:
between a
er surroun
ric materia
lymeric
gned to pl
d a second
onfronting
the body
bsorption
end region
e balloon
ster such
f the
.

ding
l
ace

and

Appeal 2011-004007
Reexamination Control 90/008,638
Patent 5,501,759

5
spectra that include high absorptivity wavelength bands, and
wherein at least one of the high absorptivity wavelength bands
of the polymeric material forming the body and at least one of
the high absorptivity wavelength bands of the polymeric
material forming the dilatation member overlap one another in
at least one range of overlapping wavelengths;
selecting a monochromatic energy wavelength that is
contained within at least one of the overlapping wavelength
ranges;
generating substantially monochromatic energy at said
monochromatic energy wavelength;
controllably directing the monochromatic energy onto the
body and the dilatation member to concentrate the
monochromatic energy in a narrow band site circumscribing the
body and running along the interface of the first and second
surface portions, thus to melt the polymeric materials along said
bond site and the immediate region thereof; and
allowing the previously melted polymeric material to
cool and solidify to form a fusion bond between the body and
dilatation member.

2. The process of claim 1 wherein:
said interface of the first and second surfaces is annular,
and the step of directing the monochromatic energy includes
focusing the beam to position a focal area of the beam
substantially at the interface, and moving the focal area, relative
to the body and the dilatation member, in an annular path along
the interface to define said bond site.

3. The process of claim 2 wherein:
the step of moving the focal area includes mounting the
body and dilatation member substantially concentrically on an
axis, and rotating the body and the dilatation member about the
axis while maintaining the beam stationary.
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Patent 5,501,759

6

4. The process of claim 3 wherein:
the focal area is circular and has a diameter of about 0.10
inches, and wherein the power of the laser is in the range of
from 1-10 watts.

5. The process of claim 4 wherein:
the body and dilatation member are rotated at a speed of
about 400 rpm for a duration in the range of from about 0.5 to
about 3 seconds.

7. The process of claim 2 wherein:
the monochromatic energy is laser energy having a
wavelength in the far infrared range.

8. The process of claim 7 wherein:
the wavelength of the laser energy is approximately 10.6
micrometers.

15. The process of claim 1 wherein:
the body is a length of catheter tubing, and the dilatation
member is a catheter balloon positioned along a distal end
region of the catheter tubing and including proximal and distal
neck portions, a medial region having a diameter substantially
larger than that of the neck portions, and proximal and distal
tapered conical regions between the medial region and
respective neck regions; and
wherein the step of directing the monochromatic energy
includes forming the bond site along the interface between the
distal neck and the catheter tubing, separated from the distal
tapered conical region by an axial distance of less than 0.030
inches.
Appeal 2011-004007
Reexamination Control 90/008,638
Patent 5,501,759

7
(Claims App’x, App. Br. 35-36, 38).

The Examiner relied upon the following as evidence of
unpatentability (Examiner’s Answer mailed November 4, 2010, hereinafter
“Ans.,” 4):
Foglia 3,560,291 Feb. 2, 1971
Becker 4,251,305 Feb. 17, 1981
Cruickshank 4,733,047 Mar. 22, 1988
Jang 4,958,634 Sep. 25, 1990
Trotta 5,290,306 Mar. 1, 1994
John F. Ready, Effects of High-Power Laser Radiation 67-87 (1971).
C. Ruffler and K. Gurs, “Cutting and Welding Using a CO2 Laser,”
OPTICS AND LASER TECHNOLOGY, 4, 265-269, (1972) (hereinafter
“Ruffler”).
SADTLER: THE INFRARED SPECTRA ATLAS OF MONOMERS AND
POLYMERS, Sadtler Research Laboratories, Division of Bio-Rad
Laboratories, Inc., 418, 420 (1980) (hereinafter “Sadtler”).

The Examiner rejected the claims under 35 U.S.C. § 103(a) as
follows:
I. Claims 1-8, 15-27, 32, and 33 as unpatentable over the
combined teachings of Jang, Trotta, Ruffler, Ready, and
Sadtler (Ans. 8-14);
II. Claims 9-11 and 28 as unpatentable over the combined
teachings of Jang, Trotta, Ruffler, Ready, Sadtler, and
Cruickshank (Ans.14-15 );
III. Claim 12 as unpatentable over the combined teachings of
Jang, Trotta, Ruffler, Ready, Sadtler, Cruickshank, and
Foglia (Ans. 15-16);
Appeal 2011-004007
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Patent 5,501,759

8
IV. Claims 13, 14, 30, and 31 as unpatentable over the
combined teachings of Jang, Trotta, Ruffler, Ready,
Sadtler, and Becker (Ans. 16-17); and
V. Claim 29 as unpatentable over the combined teachings of
Jang, Trotta, Ruffler, Ready, Sadtler, and Foglia (Ans.
17-18).

ISSUES
I.
Unless argued separately within the meaning of 37 C.F.R. §
41.37(c)(1)(vii), all claims subject to Rejection I stand or fall together with
claim 1, which we select as representative. In re Lovin, --- F.3d --- 2011 WL
2937946 (Fed. Cir. 2011).

Claim 1:
The Examiner found that Jang and Trotta both disclose a process for
making a balloon catheter from a balloon and catheter tube that may be
made of, inter alia, the same materials disclosed as preferred polymers for
the dilatation member (balloon) and the polymeric body (catheter tubing) in
the ‘759 Patent (Ans. 8-10, 22, 24). The Examiner further found that Jang
teaches laser bonding, which is the preferred fusion bonding technique
described in the ‘759 Patent, as a viable alternative to several other
conventional bonding techniques used to bond the balloon and the catheter
tubing (Ans. 9). Additionally, the Examiner found that Ruffler discloses that
CO2 laser welding (wavelength = 10.6 micrometers) offers various
Appeal 2011-004007
Reexamination Control 90/008,638
Patent 5,501,759

9
advantages in the welding (i.e., fusion bonding) of polymeric materials (Ans.
10).
Based primarily on these findings, the Examiner concluded that “[i]t
would have been obvious to one of ordinary skill in the art . . . to have
utilized a CO2 laser for bonding Jang’s thermoplastic balloon (80) and
catheter shaft (50) because Jang specifically teaches that laser welding can
be used for such bonding; and CO2 laser welding of plastic provides the
ability to very rapidly form a clean, uniform weld of improved durability,
since the stress on the film does not extend beyond the weld, as taught by
Ruffler” (Ans. 11). Regarding objective evidence of secondary
considerations, the Examiner found that the Patent Owner failed to properly
enter the evidence identified in the Appeal Brief into the record of the
current reexamination and explained that “Patent Owner’s arguments are
unacceptable as a substitute for the evidence” (Ans. 29).
The Patent Owner argues that “the Jang patent lists without any
apparent preference ‘any suitable balloon joint bonding process, such as heat
bonding, vulcanization bonding, solvent bonding, ultrasonic welding, laser
welding, and glue bonding’” (emphasis added; App. Br. 12). According to
the Patent Owner, “the Jang patent provides no enabling disclosure of how it
is possible to laser bond a balloon to a catheter shaft” (id.). In support, the
Patent Owner relies on the District Court’s Order on Motions for Summary
Judgment, which stated that “‘a passing reference to laser bonding as a
possible method for joining the balloon to the catheter body does not
necessarily imply that it is a viable solution’” (id.). And, again relying on
the District Court’s Order, the Patent Owner asserts that Ruffler does not
Appeal 2011-004007
Reexamination Control 90/008,638
Patent 5,501,759

10
contain “any teaching that a CO2 laser would be suitable for forming a bond
between a balloon and a catheter shaft” (App. Br. 13). According to the
Patent Owner, “[n]one of the cited references specify how laser welding can
be adapted to bond a balloon to a catheter shaft which are made of dissimilar
materials having non-uniform energy absorption spectra” (emphasis added;
App. Br. 16). Further, the Patent Owner asserts that laser welding
“address[es] the deficiencies of [prior art] bonding using adhesive or hot
jaws” and that the Examiner failed to consider evidence of secondary
considerations to which the Requester conceded in the concurrent district
court litigation (App. Br. 14-15, 21-25).
Distilled, the dispositive issues arising from these contentions are:
(1) Did the Examiner err in concluding that a person of ordinary
skill in the art would have been prompted to use CO2 laser bonding
(wavelength = 10.6 microns) to weld a balloon made of PET polyester and a
catheter made of HYTREL polyester in view of the collective teachings of
the prior art references, thus arriving at a process encompassed by claim 1?
(2) Did the Examiner err in holding that the Patent Owner’s
reliance on certain statements made in the District Court’s Order on Motion
for Summary Judgment was insufficient to negate a conclusion of
obviousness?
(3) Did the Examiner err in failing to consider evidence of
secondary considerations properly introduced into the record of the current
reexamination?

App
Reex
Paten

eal 2011-0
amination
t 5,501,75
1. Th

2. Ja
sy
w
po
3. Ja
Ja
ha
no
se
4. Ja
co
sa
se
26
04007
Control 9
9
F
e ‘759 Pa
laser e
infrar
micro
Hytre
polye
highly
ng describ
stem inclu
ith the cath
lymer ma
ng’s Figur
ng’s Figur
ving a firs
n-unitary
cond ballo
ng teaches
nnected to
me monol
cond ballo
).
0/008,638
INDINGS
tent states
The prefe
nergy hav
ed range, m
meters. P
l, (polyest
thylene ter
absorptiv
es a metho
ding mult
eter shaft
terial (col.
e 11 is rep
e 11 abov
t balloon 4
third ballo
on 62 (col
that the th
the cathe
ithic piece
ons 42, 62

11
OF FACT
(col. 3, ll.
rred mono
ing a wav
ost prefe
referred po
er) for the
ephthalate
e of energ
d of maki
iple balloo
from a sin
1, ll. 7-11
roduced b
e depicts a
2, a secon
on 80 loca
. 14, ll. 16
ird balloo
ter shaft 50
of polyme
and the c
(“FF”)
52-57):
chromatic
elength in
rably abou
lymeric m
catheter tu
for the ba
y at this w
ng an angi
ns that are
gle, mono
; col. 4, ll.
elow:
steerable
d balloon
ted distall
-22).
n 80 is sep
and is no
r material
atheter sha
energy is
the far
t 10.6
aterials, e
bing and
lloon, are
avelength
oplasty ca
integrally
lithic piec
32-36).
guidewire
62, and a
y of the fir
arately fo
t formed f
as are the
ft 50 (col.
.g.,
.
theter
formed
e of
catheter
separate,
st 42 and
rmed and
rom the
first and
14, ll. 22-

Appeal 2011-004007
Reexamination Control 90/008,638
Patent 5,501,759

12
5. Regarding the materials of manufacture, Jang teaches (col. 9, l.
60 col. 10, l. 1):
Any of a number of materials may be used
to make the balloon catheters of the present
invention. At least the distal end of the catheter
and the balloons are preferably formed from high-
strength thermoplastic material, which may be the
same as conventional angioplasty balloon
materials or may be other, advanced thermoplastic
materials. Balloon materials that have been used
or are now in use include polyvinylchloride,
polyethylene, polyethylene terephthalate (PET)
mylar brand polyester material (made by du Pont).
6. Specifically referring to the third balloon 80, Jang states that the
material may be the same as or different from the material of
the first balloon 42 and second balloon 62 (col. 14, ll. 43-47).
7. Jang discloses that “[t]he third balloon 80 is bonded to the
catheter shaft 50 by any conventional means, such as heat
bonding, RF bonding, laser bonding, solvent welding, adhesive
bonding, heat-shrink bonding, or other suitable technique”
(emphasis added; col. 14, ll. 47-51).

App
Reex
Paten

eal 2011-0
amination
t 5,501,75
8. Tr
Tr
in
in
co
la
9. Tr
or
10. Tr
H
11. Tr
ca
pr
12. Ru
m
13. A
ha
14. Ru
fu
04007
Control 9
9
otta’s Figu
otta’s Figu
cluding ba
ner cathete
extruded t
yer 24 (co
otta states
iented PET
otta also t
YTREL po
otta furthe
theter 12 a
ocess in a
ffler teach
aterial wor
ccording t
s a wavele
ffler teach
ndamental
0/008,638
re 1 is rep
re 1, repr
lloon 10, a
r 19, ends
ubular stru
l. 3, l. 59 t
that the b
(col. 4, l
eaches tha
lyester (c
r disclose
t its end “
conventio
es that CO
king, inclu
o Ruffler,
ngth of 10
es that th
mode can

13
roduced b
oduced ab
catheter
14 and 16
cture 22,
o col. 4, l.
alloon 10 m
l. 4-6).
t the cathe
ol. 4, ll. 21
s that the b
with an ad
nal manne
2 laser is
ding the w
coherent ra
.6 micron
e emission
be focuse
elow:
ove, depic
12, outer c
, outer tub
and an opt
59).
ay be ma
ter 12 may
-23).
alloon 10
hesive or
r” (col. 4,
particularl
elding of
diation em
s (p. 265,
from a la
d on a dia
ts a balloo
atheter tub
ular layer
ional third
de of biax
be made
may be se
by a heat s
ll. 22-25).
y suitable
plastics (A
itted from
left colum
ser oscillat
meter d =
n catheter
e 17, an
20,
hydrogel
ially
of
aled to
ealing

for
bst.).
CO2 lase
n).
ing in the
λ/(Df-1),

r
Appeal 2011-004007
Reexamination Control 90/008,638
Patent 5,501,759

14
where λ is the wavelength and Df-1 is the relative aperture (ratio
of the diameter D of the laser beam to the focal length f of the
optical system) (p. 266, left column).
15. Ruffler states that “[s]ince optical systems with a relative
aperture of 1:1 are available, the CO2 laser beam can
theoretically be focused on a spot with a minimum diameter λ =
11 μm” (p. 266, left column).
16. Ruffler states that “[t]he suitability of the laser for materials
working is dependent on the penetration depth of the beam and
the surface reflectivity, the melting and boiling points, the heat
capacity, and the thermal conductivity of the material” (p. 266,
left column).
17. Ruffler explains the benefits of CO2 laser welding as follows (p.
267, left column):
A CO2 laser permits precision welds to be
made on materials which otherwise can only be
joined satisfactorily by electron beam welding. It
allows continuous welding without deformation of
the material in the seam. The incident radiation
power can be controlled with accuracy so that the
heated zone can be minimized.
18. In discussing a specific application of laser welding (welding of
polyethylene films in the manufacture of sacks), Ruffler states
(p. 268, left column; emphases added):
[T]he laser radiation will heat the polyethylene film
in the weld almost uniformly throughout the bulk,
so that it is not necessary to wait for the heat to be
uniformly distributed by thermal conduction.
Thus, a rapid energy supply is possible and a
Appeal 2011-004007
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Patent 5,501,759

15
welding rate of 0.5 m s-1, unequalled to date, can
be attained at a laser output of 500 W. The use of
a laser also has the advantage over the
conventional method that the lossless focusing of
the laser beam on the welding zone raises the
efficiency by almost one order of magnitude and
thus reduces the operating cost significantly.
Furthermore, the laser technique yields a cleaner
weld and substantially improves its durability,
since the stress on the film does not extend beyond
the weld.

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).
“When the PTO shows prima facie obviousness, the burden then shifts
to the applicant[s] to rebut.” In re Mayne, 104 F.3d 1339, 1342 (Fed. Cir.
1997).
It is well established that a reference is good for all it fairly teaches a
person having ordinary skill in the art, even a when the teaching is a cursory
mention. E.g., In re Mills, 470 F.2d 649, 651 (CCPA 1972).

ANALYSIS
The Patent Owner does not dispute the Examiner’s finding that Jang
describes a method of making a balloon catheter by bonding a balloon 80 to
a catheter shaft 50, both of which may be made from conventional
angioplasty balloon materials such as polyesters (FF 2-6). Nor does the
Patent Owner contest the Examiner’s findings that Trotta describes a balloon
catheter including a balloon and a catheter tube made from PET and
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Patent 5,501,759

16
HYTREL, respectively, and that these polyesters are the same materials used
as the balloon (“dilatation member”) and catheter tubing (“body of
polymeric material”) in the claimed invention, respectively (FF 1, 8-11).
Rather, the Patent Owner’s position appears to be based on the belief that the
collective teachings of the prior art references fall short in accounting for the
limitation “fusion bond between the body and dilatation member,” as recited
in claim 1.
We disagree with the Patent Owner. As correctly found by the
Examiner, Jang plainly teaches that laser bonding is one of several
enumerated conventional techniques that may be used to bond the balloon 80
and catheter shaft 50 (FF 7; Ans. 9). In addition, the Examiner correctly
found that Ruffler explicitly discloses that CO2 laser bonding, which is the
same fusion bonding technique that may be used in the claimed process, is
not only suitable for welding (i.e., fusion bonding) polymeric materials but
provides many benefits including “a cleaner weld and substantially improves
its durability, since the stress on the film does not extend beyond the weld”
(FF 1, 12-18; Ans. 10). That is, as evidenced by claim 8, which recites that
“the wavelength of the laser energy is approximately 10.6 micrometers,” the
wavelength of Ruffler’s CO2 laser bonding (10.6 micrometers) would
necessarily be the same “monochromatic energy wavelength that is
contained within at least one of the overlapping ranges,” as required by
claim 1, when applied to the bonding of HYTREL catheter tubing and
polyethylene terephthalate balloon as suggested in Trotta and Jang,
HYTREL and polyethylene terephthalate being the same materials disclosed
as preferred for the claimed invention (FF 1, 5, 9, 10, 13). These facts
Appeal 2011-004007
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Patent 5,501,759

17
amply support a conclusion that a person of ordinary skill in the art would
have been prompted to use CO2 laser bonding to make the balloon catheter
of either Jang or Trotta with the reasonable expectation of obtaining the
predictable results (advantages) disclosed in Ruffler, thus arriving at a
method encompassed by claim 1.
Contrary to the Patent Owner’s belief, the absence of an explicit
preference in Jang for laser bonding over other enumerated bonding
techniques does not preclude the Examiner’s obviousness conclusion. For
one thing, the Examiner’s conclusion is based on the collective teachings of
the prior art including Ruffler, which explicitly states that CO2 laser bonding
provides many advantages. When the interrelated teachings of Jang and
Ruffler are considered together, a person of ordinary skill in the art would
have been motivated to select laser bonding over the other bonding
techniques known in the art. Moreover, we agree with the Examiner (Ans.
19) that the selection of one option from multiple alternatives disclosed in
the prior art creates a prima facie case of obviousness. Cf. Merck & Co. Inc.
v. Biocraft Labs. Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“That the ’813
patent discloses a multitude of effective combinations does not render any
particular formulation less obvious.”).
We also find no persuasive force in the Patent Owner’s argument that
Jang’s disclosure with respect to laser bonding is nonenabling. Prior art
patents are presumed to be enabled. Amgen, Inc. v. Hoechst Marion
Roussel, Inc., 314 F.3d 1313, 1354 (Fed. Cir. 2003); In re Spence, 261 F.2d
244, 246 (CCPA 1958). As stated by the Examiner (Ans. 19), Jang’s
disclosure carries with it a presumption of validity under 35 U.S.C. § 282,
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including the presumption of operability. That presumption is not overcome
with mere attorney argument. The Patent Owner has not directed us to
sufficient evidence demonstrating that a person of ordinary skill in the art
would have been unable to make the experiments and adaptations necessary
to successfully carry out Jang’s laser bonding of similar materials – one
polyester (e.g., HYTREL) to another polyester (e.g., PET) – in view of the
detailed guidance in Ruffler (FF 14-16). Cf. In re Michalek, 162 F.2d 229,
232 (CCPA 1947) (“[A] process, if used by one skilled in the art, will
produce the product alleged by the patentee and such presumption is not
overcome by a mere showing that it is possible to operate within the
disclosure without obtaining the alleged product.”).
As to the Patent Owner’s reliance on certain statements3 in the District
Court’s Order on Motion for Summary Judgment, we find ourselves in
complete agreement with the Examiner (Ans. 20). As acknowledged by the
Patent Owner (App. Br. 12-13), the Examiner is not bound by the district
court’s statements, especially given the context (summary judgment) of the
court’s statements. In district courts, the clear and convincing standard
applies. By contrast, a lower standard of proof (preponderance of the
evidence) and the broadest reasonable interpretation standard of claim
construction apply at the PTO. Therefore, the agency is not bound by the
District Court’s determination. Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1428
(Fed. Cir. 1988) (“The two forums [the Board and the courts] take different

3 For example, the Patent Owner asserts that the District Court stated: “The
Court has reviewed the [Ruffler] article and finds that it would have
provided little, if any, suggestion that CO2 lasers were a good alternative for
catheter-balloon bonding” (App. Br. 13).
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approaches in determining [patentability or] invalidity and on the same
evidence could quite correctly come to different conclusions.”); In re
Swanson, 540 F.3d 1368, 1377 (Fed. Cir. 2008) (explaining the different
standards of proof and claim construction used in reexamination relative to
civil litigation in district court). Moreover, on the record before the Office it
is not clear how the District Court holding in a summary judgment context is
consistent with the long-established tenet in patent prosecution that a
reference is good for all it would have fairly taught a person having ordinary
skill in the art. In re Mills, 470 F.2d 649, 651 (CCPA 1972).
Turning to the Patent Owner’s arguments based on secondary
considerations, the Examiner correctly pointed out that in evaluating the
evidence at the summary judgment stage, the District Court drew all
inferences in the light most favorable to the non-movant (Patent Owner) but
that that standard is inapplicable in this reexamination (Ans. 28). More
importantly, the Examiner found that the Patent Owner failed to introduce
the evidence discussed in the District Court’s Order into the record of the
current reexamination (Ans. 29). That finding has not been disputed (Reply
Brief filed December 30, 2010). 37 C.F.R. § 1.132 states that “[w]hen any
claim of . . . a patent under reexamination is rejected or objected to, any
evidence submitted to traverse the rejection or objection on a basis not
otherwise provided for must be by way of an oath or declaration under this
section.” The Patent Owner has not identified any declaration pursuant to 37
C.F.R. § 1.132 as part of the relied upon evidence in this appeal (Evidence
App’x, App. Br. 45). Thus, the Examiner has had no occasion to evaluate
whether the evidence discussed in the District Court’s Order would
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overcome the Examiner’s prima facie case of obviousness under the correct
standards applicable for the current reexamination. Hence, we find no error
in the Examiner’s holding that the Patent Owner’s assertions based on
secondary considerations are merely attorney argument.
For these reasons, we uphold the Examiner’s rejection of claim 1.

Claims 2-8, 15-19, 21-27, & 33:
The Patent Owner argues that “[n]one of the cited references specify
how laser welding can be adapted to bond a balloon to a catheter shaft which
are made of dissimilar materials having non-uniform energy absorption
spectra” (App. Br. 26). We have already found this argument unpersuasive
for reasons stated above.
The Patent Owner also refers to “[l]imitations recited in these claims”
(App. Br. 26). Because the Patent Owner has not explicitly identified what
specific limitations render the claims patentable over the prior art and why
the relied upon prior art teachings fall short, we cannot address the Patent
Owner’s arguments any further.

Claim 4:
Claim 4, which depends from claim 3, recites that “the focal area is
circular and has a diameter of about 0.10 inches” and that “the power of the
laser is in the range of from 1-10 watts.” The Patent Owner argues that
these limitations “are not merely ‘obvious optimizations/modifications’ as
suggested in the Office Action” (App. Br. 26).
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The Patent Owner’s argument, which is based solely on the further
limitations recited in dependent claim 4, is unpersuasive. Ruffler teaches
that the focal point of CO2 laser beam may be as small as 11 microns
(≈0.0004 inches) (FF 15). In addition, Ruffler indicates that the laser power
would affect the amount of energy imparted on the materials to be welded
(FF 16-18). Therefore, we agree with the Examiner that a person of ordinary
skill in the art would have arrived at optimum or workable focal point
dimensions and laser power levels through routine experimentation. In re
Aller, 220 F.2d 454, 456 (CCPA 1955) (“[W]here the general conditions of a
claim are disclosed in the prior art, it is not inventive to discover the
optimum or workable ranges by routine experimentation.”).

Claim 5:
Claim 5 recites that the “body and dilatation member are rotated at a
speed of about 400 rpm for a duration in the range of from about 0.5 to about
3 seconds.”
The Examiner found that the speed of rotation and the duration of the
laser are result-effective variables that can be optimized (Ans. 13). The
Patent Owner’s argument is not based on any limitation recited in
intervening parent claim 3 but rather that “[t]he combination of parameters
set out in claim 5 in addition to those set out in claim 4 have been found to
be significant to practicing the claimed laser bonding process in at least
some circumstances to achieve the desired configuration and/or orientation
of the bond site” (emphasis added; App. Br. 27).
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We find the Patent Owner’s argument unpersuasive because it has
failed to direct us to objective evidence (e.g., declaration evidence including
experimental results) demonstrating that the recited values are unexpectedly
critical.

Claim 15:
Claim 15 recites, inter alia, that “the step of directing the
monochromatic energy includes forming the bond site along the interface
between the distal neck and the catheter tubing, separated from the distal
tapered conical region by an axial distance of less than 0.030 inches.”
The Patent Owner contends that “if one of skill in the art were simply
to substitute a laser welding technique for the prior art hot jaw bonding
process as proposed in the rejection, then it could be assumed that the bond
site would be maintained spaced apart from the distal cone by at least 0.030
inches” and that “[t]here is no motivation in the prior art, that suggests that
the bond site could be formed at an axial distance of less than 0.030 inches,
as stated in claim 15” (App. Br. 28).
We find the Patent Owner’s argument unpersuasive for the reasons
given by the Examiner (Ans. 33). The Patent Owner has not directed us to
objective evidence demonstrating that “less than 0.030 inches” imparts a
nonobvious result over 0.030 inch. Cf. Titanium Metals Corp. v. Banner,
778 F.2d 775, 783 (Fed. Cir. 1985) (claimed alloy of 0.3% Mo, 0.8% Ni, and
balance titanium would have been obvious over two alloys in the prior art
having 0.25% Mo-0.75% Ni and 0.31% Mo-0.94% Ni).

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Claims 18, 19, 23, & 24:
The Patent Owner’s arguments for claims 18, 19, 23, and 24 are
similar to those offered in support of claim 1 (App. Br. 29-32). Therefore,
we uphold the rejection of this claim for the same reasons discussed above
for claim 1.

II-V.
The Patent Owner relies on the same arguments offered in support of
Rejection I (App. Br. 32-34). Therefore, we uphold Rejections II-V for the
same reasons well stated in the Answer and amplified above.

DECISION
The Examiner’s rejections under 35 U.S.C. § 103(a) of:
I. Claims 1-8, 15-27, 32, and 33 as unpatentable over the
combined teachings of Jang, Trotta, Ruffler, Ready, and
Sadtler;
II. Claims 9-11 and 28 as unpatentable over the combined
teachings of Jang, Trotta, Ruffler, Ready, Sadtler, and
Cruickshank;
III. Claim 12 as unpatentable over the combined teachings of
Jang, Trotta, Ruffler, Ready, Sadtler, Cruickshank, and
Foglia;
IV. Claims 13, 14, 30, and 31 as unpatentable over the
combined teachings of Jang, Trotta, Ruffler, Ready,
Sadtler, and Becker; and
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V. Claim 29 as unpatentable over the combined teachings of
Jang, Trotta, Ruffler, Ready, Sadtler, and Foglia
are affirmed.
Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).

AFFIRMED

rvb

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