Ex Parte Yassinzadeh

Patent Trial and Appeal Board

Nov 25, 2014

10821633 (P.T.A.B. Nov. 25, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ZIA YASSINZADEH
____________

Appeal 2012-006922
Application 10/821,6331
Technology Center 3700
____________

Before JAMES C. HOUSEL, GEORGE C. BEST, and
KENNETH G. SCHOPFER, Administrative Patent Judges.

SCHOPFER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for hemostasis of a puncture site in the wall of a blood vessel. The
Examiner rejected the claims as failing to comply with the written
description requirement and as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We affirm-in-part.

1 According to Appellant, the real party in interest is Cardiva Medical, Inc.
App. Br. 3.
Appeal 2012-006922
Application 10/821,633

2
STATEMENT OF THE CASE
Background
“The present invention relates generally to devices, systems, and
methods for percutaneous sealing of a puncture site in tissue tracts. More
specifically, the present invention relates to devices, systems, and methods
for hemostasis of vascular puncture sites in human bodies.” Spec. ¶ 1.
The Claims
Claims 1, 3–5, 7–11, 14, and 17–21 are on appeal. Claim 1 is
representative and reads:
1. A method for hemostasis of a puncture site in a wall of a
blood vessel at an end of a tissue tract having a sheath therein,
the method comprising:
providing a locating member having a proximal end, a
distal end, and an expansible member disposed on the distal end
thereof,
inserting the locating member through the sheath in the
tissue tract so that the expansible member on the locating
member enters a lumen of the blood vessel;
expanding the expansible member on the inserted
locating member and drawing the inserted locating member
proximally so that the expanded expansible member covers the
puncture site in the vessel wall;
removing the sheath from the tissue tract while the
inserted locating member remains in place;
providing a tubular compression member having a
proximal end, a distal end, a central passage between said
proximal end and said distal end, and an expansible tissue
compression element disposed over the distal portion thereof,
and
advancing the tubular compression member over the
inserted locating member after the sheath has been removed
Appeal 2012-006922
Application 10/821,633

3
from the tissue tract so that the locating member is received in
the central passage of the tubular compression member and a
distal end of the expansible tissue compression element is
located within the tissue tract at a predetermined distance
proximal from the wall of the blood vessel to define a tissue
compression region; and
expanding the expansible tissue compression element
within the tissue tract above the blood vessel wall to apply
pressure against subcutaneous tissue and to compress said
tissue over the puncture site in the blood vessel wall to promote
hemostasis, wherein the compression element is not in direct
contact with the vessel wall, and wherein the expansible tissue
compression element on the compression member is left in
place until hemostasis has been achieved.
App. Br. 13 (emphasis added).
The Rejections
1. The Examiner maintains that claims 1, 3–5, 7–11, 14, and 17 are
unpatentable under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement.
2. The Examiner maintains that claims 1, 3–5, 7–11, 14, 17, and 20
are unpatentable under 35 U.S.C. § 103(a) over Weldon2 in view of
Cragg.3
3. The Examiner maintains that claim 18 is unpatentable under 35
U.S.C. § 103(a) over Weldon in view of Cragg and Diaz.4
4. The Examiner maintains that claim 19 is unpatentable under 35
U.S.C. § 103(a) over Weldon in view of Cragg and Tay.5

2 Weldon et al., US 5,419,765, issued on May 30, 1995.
3 Cragg et al., US 7,621,936 B2, issued on Nov. 24, 2009.
4 Diaz, US 5,690,674, issued on Nov. 25, 1997.
5 Tay et al., US 5,507,744, issued on Apr. 16, 1996.
Appeal 2012-006922
Application 10/821,633

4
5. The Examiner maintains that claim 21 is unpatentable under 35
U.S.C. § 103(a) over Weldon in view of Cragg and Akin.6
DISCUSSION
1. Written Description
The Examiner finds that claim 1 fails to comply with the written
description requirement because the claim limitation “wherein the
compression element is not in direct contact with the vessel wall” is not
recited in the Specification. Ans. 4–5.
The dispositive issue with respect to this rejection is whether the
figures provide a sufficient “written description” for this claim limitation.
Principles of Law
For an applicant to comply with the 35 U.S.C. § 112, first paragraph,
written description requirement, the applicant’s specification must “convey
with reasonable clarity to those skilled in the art that, as of the filing date
sought, he or she was in possession of the invention.” Carnegie Mellon
Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008)
(quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir.
1991)). “[U]nder proper circumstances, drawings alone may provide a
‘written description’ of an invention as required by § 112.” Vas-Cath, 935
F.2d at 1565; see also MPEP § 2163 II(a)(3).

6 Akin et al., US 2003/0100920 A1, published on May 29, 2003.
App
App

8F p
direc
of th
supp
conc
[been

figur
meth
cont
§ 21

rever
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lication 10
Analysis
In respo
rovide sup
t contact w
The Exa
e device re
ort cannot
ludes that
] recited i
Appellan
es accordi
od for hem
act the ves
63.02).
For the r
sed.
Figures
06922
/821,633

nse to this
port for th
ith the ve
miner resp
lative to t
be based
if the “lim
n the writt
t replies t
ng to the M
ostasis an
sel wall du
easons set
8E and 8F
rejection,
e limitatio
ssel wall.”
onds that
he body ti
solely on t
itation is c
en specifi
hat written
PEP, and
d show th
ring the m
forth belo
of the Spe
5
Appellant
n that “the
App. Br.
the drawin
ssues, and
he drawing
ritical to t
cation as w
descriptio
Figures 8
at compre
ethod. Re
w, we find
cification
argues tha
compress
6.
gs do not
thus, writt
s. Ans. 8
he inventi
ell.” Id.
n support
A to 8G sh
ssion elem
ply Br. 2
that this
are reprod
t Figures
ion eleme
show the “
en descrip
. The Exa
on, it shou
may be fo
ow an ex
ent 80 doe
(citing MP
rejection s
uced below

8D through
nt is not in
true scale
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miner
ld have
und in the
emplary
s not
EP
hould be
.

”

App
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8G i
bloo

show
date,
direc
draw
the v
that
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had p
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e figures d
n which a
d vessel w
As argue
that the A
including
t contact w
n to scale
essel wall
the compre
According
lude based
ossession
06922
/821,633
epict a po
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all. Spec.
d by Appe
ppellant w
the claim
ith the ve
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, and there
ssion ball
ly, we con
on these
of the inv
rtion of th
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as in pos
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ssel wall.
separatio
is no indi
oon is adv
clude that
figures and
ention as c
6
e method s
80 is infla

find suffic
session of
nt that the
While the
n between
cation in th
anced any
one skille
the relate
laimed.
hown in F
ted over a
ient suppo
the invent
compress
figures m
the comp
e figures
further th
d in the ar
d descript
igures 8A
puncture
rt in these
ion as of th
ion elemen
ay not nec
ression ba
or the Spe
an is show
t would re
ion that th
through
site in a
figures to
e filing
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essarily be
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asonably
e inventor

e

Appeal 2012-006922
Application 10/821,633

7
Based on the foregoing, we find that the Examiner has failed to
establish that the claims are unpatentable under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
Thus, we reverse this rejection.
2. Obviousness: Weldon in view of Cragg
Appellant argues that this rejection should be reversed based on the
limitations in independent claim 1. See App. Br. 7–10. Accordingly, we
limit our analysis to the rejection of claim 1 in making our determinations
below with respect to claims 1, 3–5, 7–11, 14, 17, and 20.
The Examiner finds that Weldon teaches a method for hemostasis of a
puncture site including each of the method steps of claim 1. Ans. 5–7.
However, the Examiner acknowledges that Weldon does not disclose that
“the compression element is not in direct contact with the vessel wall.” Id.
at 7. For this limitation, the Examiner relies on Cragg and concludes that it
would have been obvious to modify the method of Weldon to use a larger
amount of hemostatic material, which would prevent the compression
element from directly contacting the vessel wall. Id.
The issue to be decided with respect to this rejection is whether the
proposed combination of Weldon and Cragg discloses or suggests that the
compression element is not in direct contact with the vessel wall.
Principles of Law
To establish a prima facie case of obviousness, the Examiner must
show that each and every limitation of the claim is described or suggested by
the combination of prior art references or would have been obvious based on
the knowledge of those of ordinary skill in the art. In re Fine, 837 F.2d
Appeal 2012-006922
Application 10/821,633

8
1071, 1074 (Fed. Cir. 1988). “[R]ejections on obviousness grounds cannot
be sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
Analysis
Appellant argues, inter alia, that this rejection should be reversed
because neither Weldon nor Cragg disclose an expansible compression
element that is not in direct contact with the vessel wall. App. Br. 9. In
particular, Appellant asserts that the Examiner relies on Cragg for this
limitation, but Cragg only “shows a delivery cannula 10 being proximally
retracted from a tissue tract above a blood vessel wall while a pusher 80
within the cannula 10 remains in place to deliver hemostatic material 30.”
Id. (citing Cragg col. 4, ll. 18–25).
The Examiner argues that Cragg discloses a compression element
(pusher 80) that is not in direct contact with a vessel wall. Ans. 7. The
Examiner concludes:
It would have been obvious to one of ordinary skill in the art at
the time of the invention to incorporate more of the hemostatic
material into the tissue tract in order to better assist in
promotion for hemostasis in the case some of the hemostasis
material fall in to the lumen of the blood vessel before the
hemostasis process begins. Hence, with the bigger amount of
hemostasis material being put into the tissue tract, the
compression element would not [sic] in direct contact with the
vessel wall.
Id. Thus, the Examiner argues that the use of a large amount of hemostatic
material as in Cragg in the method of Weldon would prevent the expansible
compression element in Weldon from being in contact with the vessel wall.
App
App

to es

to W
follo
Figu
124
a pun
the e
col.
reten
prov
bloo
13, l
eal 2012-0
lication 10
For the r
tablish a p
We agre
eldon, wh
wing. Fig
re 22F sho
located wi
cture site
xterior wa
13, ll. 5–1
tion mean
ides a mea
d flow from
l. 3–4. Th
06922
/821,633
easons set
rima facie
e with and
ich are set
ure 22F of
ws a woun
thin a bloo
; an inflate
ll of the bl
8. Further
s is design
ns to appl
the vess
e placeme
forth belo
showing o
adopt the
forth on p
Weldon i
d treating
d vessel F
d expansib
ood vesse
, Weldon i
ed to hold
y pressure
el. See id.
nt of the re
9
w, we find
f obvious
Examiner
ages 5–7 o
s reproduc
device inc
in a posit
le retentio
l; and a clo
ndicates th
the device
directly to
at col. 6,
tention m
that the E
ness.
’s findings
f the Answ
ed below.
luding an
ion to at le
n means 3
tting agen
at the pla
adjacent
the punct
ll. 65–67;
eans 32 an
xaminer h
of fact w
er. We a

inflated m
ast partial
2 located
t 65. See
cement of
to the bloo
ure site, an
col. 7, ll. 7
d the infla
as failed
ith respect
dd the
embrane
ly occlude
adjacent
Weldon
the
d vessel,
d restricts
–10; col.
ted

App
App

mem
prom

follo
Figu
inclu
guid
iden
wou
Crag
of W
has n
obvi
cont
eal 2012-0
lication 10
ber 124 al
ote clottin
In reject
wing figur
re 1c show
ding a del
ewire 54.
tifying any
ld have be
g in the de
eldon bein
ot sufficie
ous. We f
act with th
06922
/821,633
so retains
g. Id. at c
ing the cla
e in Cragg
s a system
ivery cann
Cragg col
further su
en obvious
vice of W
g separate
ntly articu
ind that th
e vessel w
the clottin
ol. 13, ll.
ims as obv
:
for facili
ula 10, a p
. 4, ll. 6–1
pport or p
to use a l
eldon, wh
d from the
lated why
e retention
all in orde
10
g agent ad
10–16.
ious, the E
tating hem
usher 80,
7. The Ex
roviding a
arger amou
ich would
vessel w
such a mo
member i
r to hold th
jacent to th
xaminer o
ostasis of
a hemosta
aminer con
ny additio
nt of hem
result in th
all. The E
dification
n Weldon
e device a
e punctur
nly cites t
a blood ve
tic materia
cludes, w
nal reason
ostatic ma
e retentio
xaminer, h
would hav
is intende
djacent to
e site to
o the
ssel
l 30, and a
ithout
ing, that it
terial as in
n member
owever,
e been
d to be in
the blood

Appeal 2012-006922
Application 10/821,633

11
vessel, provide a means to apply pressure directly to the puncture site,
restrict blood flow from the vessel, and help retain a clotting agent at the
puncture site. We are not persuaded that it would have been obvious to
deviate from Weldon’s method as the Examiner proposes.
Based on the foregoing, we conclude that the Examiner has not
established that one of ordinary skill in the art would have had an apparent
reason to combine Weldon and Cragg to achieve the claimed method.
Accordingly, we reverse this rejection.
3. Rejections 3 and 4
The Examiner does not rely on Diaz or Tay to cure the deficiency in
the rejection based on Weldon and Cragg. We therefore find that the
Examiner has not established a prima facie case of obviousness with respect
to claims 18 and 19 for the same reasons articulated with respect to the
rejection of claim 1, as described above. Accordingly, we reverse these
rejections.
4. Claim 21
Appellant asserts only that the rejection of claim 21 should be
reversed because claim 21 depends from independent claim 1, which is
distinguished from the prior art as described above. App. Br. 12. However,
claim 21 is an independent claim claiming a “kit.” Thus, Appellant’s
assertion is in error and Appellant has not identified any valid reason
showing a reversible error with respect to the rejection of claim 21.
Accordingly, we affirm this rejection.
Appeal 2012-006922
Application 10/821,633

12
CONCLUSION
For the reasons set forth above, we reverse the rejections of claims 1,
3–5, 7–11, 14, and 17–20, but affirm the obviousness rejection of claim 21.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED-IN-PART

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