Ex Parte Schraga

Patent Trial and Appeal Board

Jun 28, 2013

11616196 (P.T.A.B. Jun. 28, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte STEVEN SCHRAGA
__________

Appeal 2011-009472
Application 11/616,196
Technology Center 3700
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-11, 13, 15-17, 20, and 23-25.2 We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

1 The Real Party in Interest is Stat Medical Devices, Inc. (App. Br. 3).
2 Claims 18, 19, 21, 22, and 26-33 are also pending, but stand withdrawn
from consideration (App. Br. 3).
Appeal 2011-009472
Application 11/616,196

2
STATEMENT OF THE CASE
The Specification teaches that the “invention relates to a hypodermic
syringe having a plunger, piston and needle support structure that permits
retraction of the needle support and its needle into the barrel of the syringe
to prevent the possibility of inadvertent needle pricks and which
incorporates a frangible plunger that may be broken away to prevent
subsequent actuation of the needle to its operative position” (Spec. 1).
Claims 1 and 25 are representative of the claims on appeal, and read
as follows:
1. An injection device comprising:
a one-piece barrel having a proximal end;
a plunger comprising a portion structured and arranged to move
within the barrel and a frangible section which can be broken when the
plunger is located in a retracted position;
a needle support having a portion in sealing engagement with an inner
surface of the proximal end and being axially retained therein only by the
sealing engagement; and
a locking arrangement that one of:
selectively locks a proximal end portion of the plunger to the
needle support after the plunger is depressed completely and rotated
from an unlocked position that is visually indicated by a first symbol
to a locked position that is visually indicated by a second symbol; and
automatically locks a proximal end portion of the plunger to an
outer portion of the needle support after the plunger is depressed
completely.

25. A syringe comprising:
a one-piece barrel comprising a main internal chamber for housing a
medicine and a proximal end;
a plunger having a piston structured and arranged to move within the
main internal chamber and thumb engaging flange arranged outside the
barrel;
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Application 11/616,196

3
a needle support having a portion in sealing engagement with the
proximal end;
the needle support being structured and arranged to move axially out
of the sealing engagement and into the barrel without requiring rotation of
the needle support; and
a locking arrangement that is structured and arranged to one of:
lock a proximal end portion of the plunger to the needle support
after the plunger is in a full injection position and when the plunger is
rotated from a first position that is visually indicated by a first symbol
arranged on a distal end of the syringe to a second position that is
visually indicated by a different second symbol arranged on a distal
end of the syringe and while being in the full injection position; and
automatically lock a proximal end portion of the plunger to an
outer portion of the needle support after being moved to a full
injection position,
wherein, when the plunger is in the full injection position, the syringe
has essentially no dead space between the piston and an internal shoulder of
the barrel.

The following grounds of rejection are before us for review:
I. Claims 1-6, 8, 10, 23, and 24 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Fitzgerald3 (Ans. 4).
II. Claim 25 stands rejected under 35 U.S.C. § 102(b) as being
anticipated by Chen4 (Ans. 5).
III. Claims 7 and 9 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Fitzgerald and Tenhuisen5
(Ans. 7).

3 Fitzgerald, US 2004/0254529 A1, Dec. 16, 2004.
4 Chen, US 5,328,475, July 12, 1994.
5 Tenhuisen et al., US 6,648,849 B2, Nov. 18, 2003.
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Application 11/616,196

4
IV. Claims 1-6, 8, 10, 11, 13, 15-17, 20, and 23 stand rejected under 35
U.S.C. § 103(a) as being rendered obvious by the combination of
Lo,6 Novacek,7 and Baum8 (Ans. 7).
V. Claims 7 and 9 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Lo, Novacek, and Baum
as further combined with Tenhuisen (Ans. 9).

ISSUE (Rejections over Fitzgerald)
Does the preponderance of the evidence of record support the
Exxaminer’s finding that Fitzgerald anticipates the syringe of independent
claims 1 and 24 having “a needle support having a portion in sealing
engagement with an inner surface of the proximal end and being axially
retained therein only by the sealing engagement” (emphasis added)?

FINDINGS OF FACT
FF1. Figure 11 of the disclosure is reproduced below:

6 Lo, US 2006/0084913 A1, Apr. 20, 2006.
7 Novacek et al., US 5,858,000, Jan. 12, 1999.
8 Baum, US 4,929,238, May 29, 1990.
App
App

Figu
FF2.
(Id. a
FF3.
by F
FF4.
axial
Fitzg
FF5.
eal 2011-0
lication 11
re 11 show
The Spe
The prox
section 1
from the
leaking
30 is axi
the need
includes
spaced-a
frictiona
surface o

t 20.)
The Exa
itzgerald (
As to the
ly retain th
erald, find
Figure 1
09472
/616,196
s a cross-
cification t
imal end
2a which
proximal
out of the
ally constr
le suppo
at least
part proje
lly and/or
f the need
miner reje
Ans. 4).
limitation
e needle s
ing that su
of Fitzger
section of
eaches in
of the bar
facilitates
end. In o
syringe an
ained so t
rt 30 mo
one and
ctions 12b
sealingly
le support
cts claims
of requir
upport, th
pport 4 is
ald is repr
5
the syring
reference
rel 10 inc
insertion
rder to pr
d to ensur
hat the syr
ving prem
preferably
and 12c
engage w
30.
1-6, 8, 10
ing a seali
e Examine
press fit in
oduced be
e barrel (S
to the abov
ludes an i
of the nee
event any
e that the
inge can b
aturely, t
two or
which are
ith the ou
, 23, and 2
ng engage
r relies of
to the syr
low:
pec. 13)
e figure:
nternal tap
dle suppo
medicine
needle sup
e used wi
he section
more cir
configur
ter cylind
4as being
ment that
Figure 3 o
inge barre
ered
rt 30
from
port
thout
12
cular
ed to
rical
anticipated
serves to
f
l (id.).

App
App

Figu
Fitzg
FF6.
for s
need
“com
need
injec

havin
eal 2011-0
lication 11
re 1 shows
erald (Fitz
As taugh
ecuring ne
le 13 into
bination o
le carrier 4
ting of the
Appellan
g a portio
09472
/616,196
an elevat
gerald 1,
t by Fitzg
edle carrie
the syring
f the lock
within th
fluid into
t argues th
n in sealin
ional view
¶ 13).
erald, the “
r 4 to the
e body” (id
ing tabs 3
e syringe b
a patient”
AN
at Fitzger
g engagem
6
of the retr
syringe b
syringe bo
. at 2, ¶ 2
and the low
arrel 1 du
(id.).
ALYSIS
ald does n
ent with a

actable hy
arrel 1 inc
dy 1 prior
7). As tau
er body 2
ring loadin
ot teach “a
n inner su
podermic
ludes lock
to retracti
ght by Fitz
3 works t
g of the s
needle su
rface of th
syringe of
ing tabs 3
on of the
gerald, th
o retain th
yringe and
pport
e proxima

e
e

l
Appeal 2011-009472
Application 11/616,196

7
end and being axially retained therein only by the sealing engagement”
(App. Br. 8). Specifically, Appellant asserts that Fitzgerald teaches the use
of locking tabs 3, and thus the needle support of Fitzgerald is not axially
retained only by the sealing engagement (id.).
We agree (see FFs 5 and 6), and thus reverse the anticipation
rejection.
As to the rejection of claims 7 and 9 as being rendered obvious by the
combination of Fitzgerald and Tenhuisen, as the Examiner does not rely on
Tenhuisen to make up the above deficiencies of Fitzgerald (see Ans. 7), we
reverse it as well.

CONCLUSION OF LAW
We conclude that the preponderance of the evidence of record does
not support the Examiner’s finding that Fitzgerald anticipates the syringe of
independent claims 1 and 24 having “a needle support having a portion in
sealing engagement with an inner surface of the proximal end and being
axially retained therein only by the sealing engagement.”
We thus reverse the rejection of claims 1-6, 8, 10, 23, and 24 as being
anticipated by Fitzgerald. We also reverse the rejection of claims 7 and 9 as
being rendered obvious by the combination of Fitzgerald and Tenhuisen.

ISSUE (Rejection over Chen)
Does the preponderance of the evidence of record support the
Examiner’s finding that Chen teaches a locking arrangement that meets the
locking arrangement as required by claim 25?
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Application 11/616,196

8

FINDINGS OF FACT
FF7. The Examiner rejects claim 25 as being anticipated by Chen (Ans. 6).
FF8. The Examiner finds that Chen teaches a locking arrangement that
automatically locks (id. at 11).
FF9. Specifically, the Examiner finds that the plunger of Chen “is locked to
an outer portion of the needle support, as the plunger is locked to the needle
support as a whole it is locked to the outer surface of the needle support,
additionally as shown in Fig. 3 the plunger surrounds a portion of the outer
surface of the base of the needle support in the area where 301 is inserted”
(id.).
FF10. Figure 1 of Chen is reproduced below.
App
App

Figu
FF1
porti
shan
eal 2011-0
lication 11
re 1 shows
1. As show
on 230, an
k portion 2
09472
/616,196
the syring
n in the Fi
d at least o
2 (id. at c
e of Chen
gure, the n
ne biasing
ol. 2, ll. 26
9

ready for
eedle dev
socket 27
-38).
use (Chen
ice 2 inclu
formed i
, col. 1, ll
des a rear
n a rear po
. 56-57).
needle end
rtion of a

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Application 11/616,196

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FF12. The plunger 3 includes a coupling member 30 that has an arrowhead
portion 301 formed at the front end of the coupling member that may be
inserted into biasing socket 27 (id. at col. 2, l. 64-col. 3, l. 2).
FF13. Chen teaches that when the syringe is used to inject a patient:
The arrowhead portion 301 of the coupling member 30
will then be forcibly inserted into the biasing socket 40 of the
needle device 2 to squeeze, and expansively bifurcate the rear
needle portion 230 of the needle device 2 to store a resilient
potential energy of the bifurcated rear needle portion, thereby
operatively coupling the coupling member 30 with the needle
device 2.

(Id. at col. 3, ll. 39-45.)
FF14. Figure 3 of Chen is reproduced below.
App
App

Figu
ll. 60
FF15
arrow
ll. 47

eal 2011-0
lication 11
re 3 shows
-61).
. As show
head port
-57).
09472
/616,196
retraction
n in Figur
ion 301 of

of the nee
e 3, the bia
the coupl

11
dle into th
sing sock
ing memb
e syringe
et 27 is sn
er 30 of pl
of Chen (i
ugly engag
unger 3 (id
d. at col. 1
ed with
. at col. 3

,
,
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Application 11/616,196

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ANALYSIS
Appellant argues that Chen does not teach the locking arrangement
required by the claim (App. Br. 14). Specifically, Appellant argues that
Chen teaches that the plunger is locked via axial movement of the plunger
without rotating the plunger (id.).
Appellant argues further Chen teaches to lock member 301 into
member 27, and not to automatically lock a proximal end portion to an outer
portion of the needle support (id.). According to Appellant, the “socket 27
in CHEN is an inner portion and not an outer portion of the needle support”
(Reply Br. 7). Appellant argues further that “there is no locking engagement
between elements 230 and 32 even though element 230 can seat into the
socket 32” (id.).
Appellant’s arguments are not convincing. Claim 25 requires
a locking arrangement that is structured and arranged to one of:
[a] lock a proximal end portion of the plunger to the needle
support after the plunger is in a full injection position and when the
plunger is rotated from a first position that is visually indicated by a
first symbol arranged on a distal end of the syringe to a second
position that is visually indicated by a different second symbol
arranged on a distal end of the syringe and while being in the full
injection position; and
[b] automatically lock a proximal end portion of the plunger to
an outer portion of the needle support after being moved to a full
injection position.

Thus, if Chen teaches a locking arrangement as set forth by clause [a] or
clause [b], it anticipates the claimed locking arrangement.
We agree with the Examiner that Chen teaches a locking arrangement
as required by clause [b] as set forth above. While Appellant argues that
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Application 11/616,196

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socket 27 of Chen is not an outer portion of the needle support, Appellant
points to no definition or portion of the Specification that would define
“outer portion” as excluding socket 27 of Chen. See In re American
Academy Of Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004)
(noting that during prosecution before the Office, claims are to be given their
broadest reasonable interpretation consistent with the Specification as it
would be interpreted by one of ordinary skill in the art). Thus, as the biasing
socket sits behind the front end of the needle portion 21 of Chen, it reads on
“an outer portion” of the needle support of Chen.

CONCLUSION OF LAW
We conclude that the preponderance of the evidence of record
supports the Examiner’s finding that Chen teaches a locking arrangement
that meets the locking arrangement as required by claim 25. We thus affirm
the rejection of claim 25 as being anticipated by Chen.

ISSUE (Rejections over Lo)
Does the preponderance of the evidence of record support the
Examiner’s conclusion that claim 1 is rendered obvious by the combination
of Lo, Novacek, and Baum?

FINDINGS OF FACT
FF16. The Examiner rejects claims 1-6, 8, 10, 11, 13, 15-17, 20, and 23 as
being rendered obvious by the combination of Lo, Novacek, and Baum
(Ans. 7). As Appellant does not argue the claims separately, we focus our
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Application 11/616,196

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analysis on claim 1, and claims 2-6, 8, 10, 11, 13, 15-17, 20, and 23 stand or
fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii).
FF17. The Examiner finds that Lo teaches an injection device (Ans. 7).
FF18. Specifically, the Examiner finds that Lo teaches “a needle support
having a portion in sealing engagement with an inner surface of the proximal
end and being axially retained therein only by the sealing engagement (Fig.
1A support 8 taken as press fit)” (id.).
FF19. The Examiner also finds that Lo teaches a locking arrangement that
requires rotation of the plunger is fully depressed (id. at 7-8).
FF20. The Examiner notes that Lo does not teach a frangible section, nor the
use of visual indicia (id. at 8).
FF21. The Examiner finds that Novacek teaches “using a breakable plunger
because it increases the safety of the device as it prevents the needle from
being re-pushed out through the hub and it allows for easier disposal” (id.).
FF22. The Examiner finds that “Baum teaches using visual indicia to
indicate when a plunger is in a locked or unlocked state (Fig. 18) this allows
the user to be able to quickly ascertain the status of the device” (id.).

ANALYSIS
Appellant argues that Lo does not teach a plunger comprising a
frangible section, a needle support having a portion in sealing engagement
with an inner surface of the proximal end and being axially retained therein
only by the sealing engagement, or the claimed locking arrangement (App.
Br. 16). As to the locking arrangement, Appellant argues that Lo does not
teach the use of visual indicia or an automatic locking position.
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Specifically, as to the limitation of being axially retained therein only
by the sealing engagement, Appellant argues that Lo utilizes projection 4
and recess 6/81 to retain the needle support to the body 3 (Reply Br. 8
(citing Lo, ¶ 29). Appellant further argues that those elements “do not
appear to participate in sealing which appears to occur as a result of contact
between the outer surface of section 80 and the inner surface of the barrel 3”
(id. at 8-9).
Appellant argues further that neither Novacek nor Baum remedy the
deficiencies of Lo (id. at 16-17).
First, as to the locking mechanism, claim 1 states:
a locking arrangement that one of:
[a] selectively locks a proximal end portion of the plunger to
the needle support after the plunger is depressed completely and
rotated from an unlocked position that is visually indicated by a first
symbol to a locked position that is visually indicated by a second
symbol; and
[b] automatically locks a proximal end portion of the plunger to
an outer portion of the needle support after the plunger is depressed
completely.

Thus, similarly as to claim 25 as discussed above, claim 1 requires a
locking mechanism that meets [a] or [b]. The Examiner finds that Lo
teaches all of the limitations required by clause [a], except for the use of
visual indicators. The Examiner relies on Baum to remedy that deficiency
(FF22). As Appellant does not point to any errors as to the Examiner’s fact
finding with respect to Baum, or as to the Examiner’s reasoning as to why
one would use the visual indicia of Baum with the syringe of Lo, we agree
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with the Examiner that the combination teaches all of the limitations of the
locking mechanism of clause [a] of claim 1.
As to the use of a frangible plunger, the Examiner acknowledges that
Lo does not teach a frangible plunger (FF20), and relies on Novacek for its
teaching of a frangible plunger (FF21). ). As Appellant does not point to
any errors as to the Examiner’s fact finding with respect to Novacek, of as to
the Examiner’s reasoning as to why one would use the frangible plunger of
Novacek with the syringe of Lo, we agree with the Examiner that the
combination teaches the limitation of a frangible plunger.
Finally, as to Appellant’s argument that Lo does not teach a needle
support having a portion in sealing engagement with an inner surface of the
proximal end and being axially retained therein only by the sealing
engagement, we note that as taught by the instant Specification, the syringe
barrel of the instant invention may include one or two or more circular
spaced-apart projections that are configured to frictionally and/or sealingly
engage with the outer cylindrical surface of the needle support (FF2). Thus,
the Specification does not exclude the use of depressions or projections to
aid in sealingly engaging the needle support to the barrel of the syringe.
And while Appellant argues that the depressions and projections as taught by
Lo “do not appear to participate in sealing” (Reply Br. 8), Appellant points
to no portion of Lo to support that statement. The use of “comprising” does
not exlude the use of more than one portion of the needle support being in
sealing engagement with the proximal end of the barrel.
As to the rejection of claims 7 and 9 over the combination of Lo,
Novacek, and Baum as further combined with Tenhuisen, Appellant only
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argues that Tenhuisen does not remedy the above deficiencies of the
combination of Lo, Novacek, and Baum (id. at 17). We thus affirm that
rejection for the reasons set forth above.

CONCLUSION OF LAW
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that claim 1 is rendered obvious by the
combination of Lo, Novacek, and Baum. We thus affirm the rejection of
claim 1. Claims 2-6, 8, 10, 11, 13, 15-17, 20, and 23 fall with that claim.

SUMMARY
We reverse the rejections of:
Claims 1-6, 8, 10, 23, and 24 under 35 U.S.C. § 102(b) as being
anticipated by Fitzgerald; and
Claims 7 and 9 stand rejected under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Fitzgerald and Tenhuisen.

We affirm the rejections of:
Claim 25 under 35 U.S.C. § 102(b) as being anticipated by Chen
Claims 1-6, 8, 10, 11, 13, 15-17, 20, and 23 under 35 U.S.C. § 103(a) as
being rendered obvious by the combination of Lo, Novacek, and Baum; and
Claims 7 and 9 under 35 U.S.C. § 103(a) as being rendered obvious by
the combination of Lo, Novacek, and Baum as further combined with
Tenhuisen.

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18
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-IN-PART

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