Ex Parte Boyd

Patent Trial and Appeal Board

Mar 25, 2014

10625145 (P.T.A.B. Mar. 25, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte STEPHEN W. BOYD
____________

Appeal 2012-002273
Application1 10/625,145
Technology Center 3700
____________

Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a device
for removing material from a vessel wall. The Examiner has rejected the
claims as anticipated and obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We reverse.

1 Appellant identifies Tyco Healthcare Group LP as the Real Party in
Interest (App. Br. 3).
Appeal 2012-002273
Application 10/625,145

2
STATEMENT OF THE CASE
The Specification describes a material removing device using a cage
that “protects healthy tissue by limiting the amount of material which is
removed.” (Spec. 3, ll. 1-4.)
[The] cage preferably forms 2-20 openings, more preferably 4-8
openings, which are spaced around the device. An advantage of
the present invention is that the user does not need to rotate the
device to orient a single cutting window. . . . The material
extending into and through the openings is sheared by shearing
surfaces on the cage and removal element. The material
removing element preferably removes material around a
significant portion of the cage but may also selectively remove
material extending into the openings.
(Spec. 2, ll. 1-20.) In addition, the method can be used for “removing neo-
intimal tissue and other material from the inside of a previously deployed
stent. . . . [The method] is particularly useful for this procedure since the
cage prevents the material removing element from contacting the stent.”
(Spec. 3, ll. 10-13.) The Specification also describes that “the material
removing element may be used a number of times before deploying the cage
so that material may be removed at a number of vascular sites before the
cage is deployed.” (Spec. 11, ll. 16-18.)
Claims 16, 28-35, 63, and 64 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief. Claim 16 is representative of the
claims on appeal, and reads as follows (emphasis added):
16. A device for removing material from a vessel wall at a
vascular site, comprising:
a cage which is movable from a collapsed position to an
expanded position, the cage having a plurality of openings in
the expanded position, the openings being formed by rigidly
connected elements, the cage being configured such that when
the cage is in the expanded position at the vascular site material
Appeal 2012-002273
Application 10/625,145

3
from the vessel wall extends from the vessel wall into the
openings, the cage having an inner surface which defines a
cavity, the cage being releasable so that the cage may be left
within the patient; and
a material removing element positioned within the cage
cavity to remove the material from the vessel wall extending
into the openings when the cage is in the expanded position, the
material removing element being positioned beneath the cage
and being configured to be movable along the inner surface of
the cage to remove the material extending into the openings.
Claim 28, the only other independent claim, includes the additional
limitation of a “sheath being retractable relative to the cage to expose the
cage and permit the cage to expand.”

The Examiner has rejected the claims as follows:
I. claim 16 under 35 U.S.C. § 102(e) as being anticipated by
Passafaro;2
II. claims 63 and 64 under 35 U.S.C. § 103(a) as being obvious
over Passafaro in view Reger;3
III. claims 28-30 and 33-35 under 35 U.S.C. § 103(a) as being
obvious over Passafaro in view Klein;4 and
IV. claims 31 and 32 under 35 U.S.C. § 103(a) as being obvious
over Passafaro in view Klein and further in view of Reger.

I-II. Rejections based on Passafaro alone or in combination with Reger
The Examiner takes the position that Passafaro disclosed:

2 James D. Passafaro et al., US 6,156,046, issued Dec. 5, 2000.
3 Vincent A. Reger et al., US 5,211,651, issued May 18, 1993.
4 Enrique J. Klein et al. US 5,776,141, issued July 7, 1998.
Appeal 2012-002273
Application 10/625,145

4
a cage (a stent S, as best seen in figures 10I-M) which is
movable from a collapsed position to an expanded position, the
cage having a plurality of openings (see figures 10I-K) . . . the
cage S having an inner surface which defines a cavity, the cage
being releasable so that the cage may be left within the patient;
and a material removing element 54 positioned within the cage
cavity to remove the material from the vessel wall extending
into the openings when the cage is in the expanded position, the
material removing element being 54 positioned beneath the
cage as best seen in figures 10I-J and being configured to be
movable along the inner surface of the cage to remove the
material extending into the openings.
(Ans. 4-5.)
Does the preponderance of the evidence of record support the
Examiner’s finding that Passafaro disclosed the recited device?

Findings of Fact
FF 1. Passafaro disclosed that Fig. 10A-M
illustrate the use of the system 30 in connection with a blood
vessel BV that has been partially occluded by occluding
material OM at the region where a stent S had previously been
implanted, the system 30 can also be used with a non-stented
blood vessel BV that has been partially occluded (i.e., stenosed)
by occluding material OM.
(Passafaro col. 20, ll. 7-13; Ans. 4.)
FF 2. Passafaro disclosed a system for removing occluding material
from a lumen.
App
App

Pass
bloo
impl

(Pas

(Reg

Anal
expa
cavit
eal 2012-0
lication 10
afaro’s Fig
d vessel (B
anted. (Pa
FF 3. Pa
[t]he rem
helical g
the porti
the remo
distal en
the occlu
material
safaro col.
FF 4. R
filter 26
membra
polyeste
which ar
enough t
er col. 14
ysis
Appellan
ndable cag
y defined
[T]he sy
02273
/625,145
10 I, repr
V) at a re
ssafaro co
ssafaro ex
oval me
uide secti
ons of the
val mecha
d 38 of the
ding mat
OM will h
22, ll. 36-
eger disclo
2 in the fo
ne 264 o
r fabric de
e small en
o obstruct
,ll. 51-56;
t contend
e, and (2)
by an inne
stem whic
oduced ab
gion were
l. 20-22; A
plains tha
chanism 5
on 200 as
helical gu
nism 54 b
catheter
erial OM,
ave been
43; Ans. 4
sed the a c
rm of a st
f an app
fining sui
ough not
smaller ar
Ans. 5.)
s that the c
a material
r surface o
h is disclo
5
ove, show
a stent (S)
ns. 4.)
t
4 follows
it is guide
ide section
ecome str
32 reaches
a helical c
removed.
.)
atheter ar
ocking-lik
ropriate m
tably sma
to permit p
teries or c
laimed de
removing
f the cage
sed by Pa
s occludin
had previ
the helic
d therealo
200 that
aightened.
the distal
hannel H
therotome
e generall
aterial su
ll opening
assage of
apillaries.
vice comp
element p
.” (App. B
ssafaro do
g material
ously been
al path o
ng. How
are proxim
. . . Whe
-most exte
C of occlu
with the u
y tubular
ch as w
s, i.e., ope
particles
rises both
ositioned
r. 6.)
es not inc
(OM) in a

f the
ever,
al to
n the
nt of
ding
se of a
filter
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ning
large
“(1) an
within a
lude

Appeal 2012-002273
Application 10/625,145

6
the stent which is described as having been previously
implanted, nor does it include any other structure which could
be considered to comprise a cage. The stent merely forms a
part of the environment in which the system disclosed by
Passafaro may be used.
(App. Br. 7.) “[T]he ‘device’ indentified [sic] by the Examiner as
anticipating claim 16 comprises a stent left at the treatment site during a first
treatment procedure and the removal mechanism of Passafaro’ s device
which is used during a second treatment procedure to remove material from
within the stent.” (App. Br. 8)
The Examiner takes the position that
[a]lthough, the system disclosed by Passafaro is for removing
stenotic material from blood vessel in which a stent has been
previously implanted . . ., Passafaro discloses in figs. 10I-M, a
stent S is equivalent as a cage and a material removal element
54 is positioned within the cage cavity. Thus, these two distinct
devices are capable of being used together in this one device of
Passafaro’s system for guided atherectomy. In this case,
Passafaro’s system, figures, 10I-M, stent S has the feature of
the cage and function similar as recited in claim 16 . . . [in that
it] holds the vessel open in much the same manner as a stent.
(Ans. 8-9 (emphasis omitted).)
We agree with Appellant’s position that the claims are directed to a
device comprising a cage and a material removing element. Although the
open claim language, of “a device . . . comprising,” allows for the inclusion
of additional elements, the device minimally requires a cage and a material
removing element. The Examiner takes the position that the following claim
limitations are functional and/or intended use limitations:
(1) “moveable from a collapsed position to an expanded
position” and that the cage be (2) “releasable so that the cage
may be left within the patient” that do not impart any structure
Appeal 2012-002273
Application 10/625,145

7
limitation into the device which is capable of being used as
claimed if one desires to do so.
(Ans. 9.) We do not agree with the Examiner’s interpretation that these
limitations are solely functional. The “collapsed” or “expanded” form of a
stent provides a description that imparts structural information about the
stent shape. In addition, the limitation that the cage is “releasable” from the
device implies that there is a connection with the device before the cage can
be let go from the device. Thus, we agree with the Appellant’s position that
the device as claimed requires a cage and a tissue removal element.
We agree with the Examiner’s position that Passafaro shows a tissue
removing element that can be used in a previously stented blocked blood
vessel (Ans. 8). Passafaro also disclosed that the same tissue removing
element can be used in a vessel that is not stented (FFs 1-3). The Examiner
looks to the Specification to establish that the cage can function in much the
same way as a stent. The Examiner then concludes that the previously
deployed stent disclosed in Passafaro meets the claim limitation of an
expandable cage, that functions similar to the cage recited in claim 16 (Ans.
8-9). We agree with the Examiner that the previously placed stent meets the
limitation of a cage, what is missing in the Answer is an identification of the
structure that the Examiner considers to be the device that provides the cage
in conjunction with the material removing element as required by the claim.
To anticipate, every element and limitation of the claimed invention must be
found in a single prior art reference, arranged as in the claim. Karsten Mfg.
Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001).
Although we recognize that the claim provides that the cage may be
left in a patient, the device, never the less, still requires that the cage and
Appeal 2012-002273
Application 10/625,145

8
tissue removal device be connected in some way so that the cage may be
released from the device. Passafaro disclosed a method of removing
occluding material from a previously stented blood vessel using a tissue
removal device (FFs 1-3). The Examiner has not pointed to any persuasive
evidence that the device used to place the stent is the same as the device that
is used to introduce the tissue removing element. We do not agree with the
Examiner’s position that two distinct devices that are capable of being used
together sequentially anticipates a claim that is directed at a device that
comprises, at least for a period of time, the presence of both a stent (i.e.
cage) and a tissue removal element.
In sum, as we are not persuaded, for the reasons discussed, that the
Examiner has adequately explained how or Passafaro’s system describes,
within the meaning of 35 U.S.C. § 102, a device having the features required
by claim 16, we reverse the Examiner’s anticipation rejection of this claim.
Claims 63 and 64, recite the additional limitation of a bag coupled to
the material removing element. The Examiner looks to Reger to provide the
limitation of a bag attached to a tissue removal element (FF 4). This
rejection relies on the underlying anticipation rejection of claim 16 over
Passafaro. Having reversed the rejection of claim 16, we necessarily reverse
this obviousness rejection over claims 63 and 64 including a collapsible bag
attached to the tissue removing device because Reger does not cure the
deficiency of Passafaro’s device.

II. The Issue: Rejections based on Passafaro and Klein
The Examiner takes the position that Passafaro disclosed all elements
of the claim
App
App

(Ans
Exam
the c
remo
Addi

pros
eal 2012-0
lication 10
but fails
a sheath
expose
expanda
sheath 7
the cage
ordinary
modify t
containe
to the ca
proper s
. 10.)
Does the
iner’s con
laim limit
ving elem

tional Fin
FF 5. K
thesis prio
Fig 10, r
A delive
the stent
The eve
location
74. Initi
02273
/625,145
to disclos
and the
or expand
ble cage S
0 is retrac
. . . . [I]
skill in th
he device
d within a
ge to exp
tent to intr
preponde
clusion th
ation of a d
ent?
dings of F
lein disclo
r to balloo
eproduced
ry catheter
retaining
rtible shea
71 folded
ally, a dis
e an expan
sheath is
the cage
being co
table relati
t would h
e art at th
of Passaf
sheath an
ose or exp
aluminal t
rance of th
at the com
evice com
act
sed “empl
n deploym
above, sh
12 emplo
structure
th 70 is a
over into
tal fold 7
9
dable cag
retractable
. Howev
ntained wi
ve to the c
ave been
e time th
aro with a
d the she
and the c
arget sites
e evidenc
bination o
prising a
oying an e
ent.” (Kle
ows:
ying an ev
is illustra
ttached to
an inner la
6 on the
e being co
relative
er, Klein
thin a she
age to exp
obvious
e inventio
n expanda
ath is retra
age in ord
.
e of record
f Passafar
sheath, a c
vertible sh
in col. 6,
ertible sh
ted in FIG
the cathe
yer 72 and
sheath 70
ntained w
to the cag
et al teac
ath 70 an
ose or ex
to one ha
n was ma
ble cage b
ctable rel
er to deliv
support t
o and Kle
age, and a
eath for co
ll. 47-49.)
eath 70 ste
S. 10 and
ter body
an outer
is constra
ithin
e to
h an
d the
pand
ving
de to
eing
ative
er a
he
in meets
material
vering a
nt as
11.
16 at
layer
ined
App
App

(Kle
may
FIG
inter
line
Anal
on th
for b
(App
eal 2012-0
lication 10
within a
over dist
80 is att
sheath 7
in col. 11,
FF 6. Fi
be proxim
. 11. After
nal balloon
in FIG. 11

ysis
There ar
e combina
oth rejecti
Appellan
a person
incorpor
no reaso
remove
person o
occluded
be no re
the stent
. Br. 11)
02273
/625,145
n annular
al end of
ached to t
0.
ll. 52-60;
g. 11 of K
ally withd
the stent
catheter
.” (Klein
e two obvi
tion of Pa
ons we wi
t contend
of skill in
ate a stent
n to comb
occluding
f skill in
, if at all,
ason to in
is initially

retainer 78
the cathete
he proxim
Ans. 6.)
lein, repro
rawn to pu
S has been
14 as desc
col. 11, ll.
ousness re
ssafaro an
ll discuss t
s that
the art wo
into the s
ine a sten
material
the art
only after
clude a m
implanted
10
which ra
r body an
al end of
duced belo
ll back th
uncovere
ribed prev
60-65.)
jections th
d Klein. A
hem toget
uld have n
ystem dis
t delivery
from an i
understand
the passag
aterial rem
.
dially con
d the stent
the outer
w shows
e sheath 70
d it may b
iously and
at are bas
s the sam
her (see A
o reason
closed by
catheter w
mplanted
s that a
e of time
oval dev
strains the
S. A pul
layer 74 o
a “pullwir
as illustr
e deployed
illustrated
ed, in who
e issue is d
pp. Br. 12
to intentio
Passafaro
ith a devi
stent sinc
stent beco
so there w
ice at the
end
lwire
f the
e 80 [that]
ated in
by the
in broken

le or part,
ispositive
).
nally
. . . .
ce to
e the
mes
ould
time

Appeal 2012-002273
Application 10/625,145

11
The Examiner contends that Passafaro disclosed a cage that was
“movable from a collapsed position to an expanded position, the cage having
a plurality of openings” (Ans. 9). The Examiner acknowledges that
“Passafaro fails to disclose an expandable cage being contained within a
sheath . . . . Klein et al teach an expandable cage S being contained within a
sheath 70 and the sheath 70 is retractable relative to the cage to expose or
expand the cage” (Ans. 10).
We find that the Appellant has a better position. The Examiner relies
on Klein for the teaching of a sheath, concluding that it would have been
obvious “to modify the device of Passafaro with an expandable cage being
contained within a sheath and the sheath is retractable relative to the cage to
expose or expand the cage in order to deliver a proper stent to intraluminal
target sites” (Ans. 6). The proposed modification by the Examiner is to
include a sheath with the device of Passafaro, thus, the Examiner’s rejection
is premised on the prior finding that Passafaro disclosed a device that
contains a cage and a tissue removing element (see above I.-II.). As
discussed above (I.-II.), we do not agree with the Examiner’s finding that
Passafaro disclosed such a device. Consequently, we do not agree with the
Examiner’s conclusion that the combination of Klein’s sheath with
Passafaro’s device meets all the recited claim limitations. “[O]bviousness
requires a suggestion of all limitations in a claim.” CFMT, Inc. v. Yieldup
Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003).
As the Examiner has failed to adequately articulate any other rationale
explaining how the combination of Passafaro and Klein discloses a device
comprising a cage, sheath, and tissue removal element, we are constrained to
reverse each rejection that relies on Passafaro and Klein.
Appeal 2012-002273
Application 10/625,145

12

SUMMARY
We reverse the rejection of claim 16 under 35 U.S.C. § 102(e) as
being anticipated by Passafaro.
We reverse the rejection of claims 63 and 64 under 35 U.S.C. § 103(a)
as being obvious over Passafaro in view Reger.
We reverse the rejection of claims 28-30 and 33-35 under 35 U.S.C.
§ 103(a) as being obvious over Passafaro in view Klein.
We reverse the rejection of claims 31 and 32 under 35 U.S.C. § 103(a)
as being obvious over Passafaro in view Klein and further in view of Reger.

REVERSED

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