Ex Parte Summerville et al

Board of Patent Appeals and Interferences

Mar 28, 2012

11294256 (B.P.A.I. Mar. 28, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
11/294,256 12/05/2005 Andrew G. Summerville P-6811 7219
26253 7590 03/29/2012
David W. Highet, VP & Chief IP Counsel
Becton, Dickinson and Company
1 Becton Drive
MC 110
Franklin Lakes, NJ 07417-1880
EXAMINER
BERDICHEVSKY, AARTI
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
03/29/2012 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 ANDREW G. SUMMERVILLE, JON D. SWENSON, and
CHRISTINA JOY D’ARRIGO
__________

Appeal 2010-009568
Application 11/294,256
Technology Center 3700
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and FRANCISCO PRATS,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a cutting
element for a retractable syringe. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
STATEMENT OF THE CASE
The Specification discloses that the “prior art includes retracting
needle syringes which include a spring loaded needle assembly … and a
hollow plunger rod” (Spec. 1:26-28). “Upon completion of the injection
Appeal 2010-009568
Application 11/294,256

2
process[,] additional distally directed force is applied to the plunger causing
an internal cutting element to cut through the end of the hollow plunger rod
and the support for the spring-loaded needle” (id. at 2:6-8). “[T]his allows
the spring-loaded needle to enter the cavity in the plunger” (id. at 2:11-12).
The Specification discloses “an improved cutting element for a retracting
needle syringe” (id. at 2:19-20).
Claims 1, 2, and 4-22 are on appeal.1 Claim 1 is representative and
reads as follows:
1. A cutting element for a retracting needle syringe having a plunger
with a cuttable distal end and a spring biased needle held in an energized
state by a cuttable support and said cutting element capable of cutting said
cuttable distal end and said cuttable support comprising:
a body portion having a proximal end, a distal end, a side wall
therebetween defining a longitudinal axis and a passageway therethrough,
said distal end including a cutting edge and a plurality of raised
distally projecting tapered cutting teeth each having a distal tip and distally
converging edges, at least one tooth edge having a sharp side wall for cutting
said distal end of said plunger and said support.

Issue
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 103(a) as being obvious in view of Caizza2 and Sommerstein.3 The claims
have been argued in several groups, as discussed below; the claims in each
group stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii).

1 Appellants state that “[c]laims 4-8, 10-14, 16 and 17 depend from claim 3,
which has been cancelled. The claims will be amended to depend from claim
1 upon indication of allowable subject matter” (Appeal Br. 18, footnote).
Thus, for the purposes of this appeal, we will treat the claims that depend on
claim 3 as depending on claim 1 instead.
2 Caizza, US 6,517,516 B1, Feb. 11, 2003
3 Sommerstein, US 2,590,900, April 1, 1952
Appeal 2010-009568
Application 11/294,256

3
The Examiner finds that Caizza discloses a retracting needle syringe
comprising a cutting element meeting the limitations of claim 1 except that
Caizza “fails to teach a plurality of cutting teeth” (Answer 4). The Examiner
finds that Sommerstein discloses a cutting element for a syringe that has a
plurality of sharply serrated cutting teeth (id.), and concludes that it “would
have been obvious to one having ordinary skill in the art … to modify the
cutting element of Caizza with a plurality of teeth, as taught by
Sommerstein, as this would improve the efficiency of cutting” (id. at 4-5).
Appellants contend that the cited references do not identify a problem
with the Caizza cutting edge that would suggest modification, and that one
of skill in the art would not apply Sommerstein’s disclosure to Caizza’s
cutting element since Sommerstein is directed to piercing and only partially
severing a diaphragm, rather than cutting all the way through a barrier
(Appeal Br. 14-16). As noted above, Appellants also argue that some of the
other claims are separately patentable from claim 1.
The main issue presented is: Would the cited references have made
obvious a retracting needle syringe cutting element with a distal end that
includes “a cutting edge and a plurality of raised distally projecting tapered
cutting teeth each having a distal tip and distally converging edges, at least
one tooth edge having a sharp side wall for cutting” the plunger and the
needle support of the syringe?
Findings of Fact
1. We adopt the Examiner’s findings regarding the scope and content
of Caizza (Answer 4).
App
App

claim
of cu
use i
the a
bein
is de
Figu
pisto
col.

comb
col.

suita
col.
eal 2010-0
lication 11
2. The E
1 except
tting teeth
3. Somm
n syringes
4. Somm
mpule wh
g introduc
sired” (id.
5. Figur
re 4 shows
n-closure
2, ll. 8-12)
6. Somm
ined hous
3, ll. 22-25
7. Somm
ble rubber
3, ll. 30-32
8. Figur
09568
/294,256
xaminer f
a cutting e
(id.). Ap
erstein di
of the hyp
erstein di
ich carries
ed to said v
at col. 1, l
e 4 of Som
“an enlar
… showin
.
erstein di
ing and cu
).
erstein di
or rubber
).
e 6 of Som
inds that C
lement th
pellants do
scloses “im
odermic t
scloses “a
the drug f
ehicle up
l. 9-13).
merstein
.
ged longit
g the drug
scloses th
tter eleme
scloses th
compositi
merstein
4
aizza disc
at includes
not dispu
proveme
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n element
ree of the
on the pun
is shown b
udinal sect
element [
at the pisto
nt designa
at “piston
on or any
is shown b
loses all o
a cutting
te this find
nts in amp
merstein,
adapted to
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cturing of
elow:

ional view
D] in posit
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ted by the
12 is prefe
other suita
elow:
f the limit
edge with
ing.
ules or car
col. 1, ll. 1
form a cl
vehicle, s
the closur
of [an] im
ion therein
includes “
numeral 1
rably form
ble materi
ations of
a plurality
tridges fo
-3).
osure for
aid drug
e when us
proved
” (id. at
a
3” (id. at
ed of
al” (id. at

r
e
App
App

Figu
plun
adva
the p
vehi
parti
16 fo
show
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18, a
the d
any a
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cylin
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of an
prod
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lication 11
re 6 shows
ger of the
nced to th
iston-clos
cle or solu
9. Somm
ally sever
rming the
n at 17” (
10. Som
tion … wit
nd the cyl
iaphragm
brasive ef
11. Som
ehicle V,
drical por
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12. Som
y suitable
uction of a
09568
/294,256
a longitu
syringe ap
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tion” (id. a
erstein di
the diaphr
wall of th
id. at col. 4
merstein d
h the cylin
indrical po
14 to be …
fects” (id.
merstein d
as shown i
tion 15 ma
at col. 4, l
merstein d
material,
n efficien
dinal sectio
plied and t
of punctur
ug elemen
t col. 2, ll
scloses th
agm 14, th
e housing
, ll. 8-12)
iscloses th
drical por
rtion 15 is
puncture
at col. 4, l
iscloses th
n Figure 6
intains the
l. 61-64).
iscloses th
such as alu
t cutting ed
5
n through
he combin
ing or part
t being sho
. 18-24).
at in “orde
e peripher
is notched
.
at “the w
tion 15 is
rounded,
d without
l. 16-22).
at “[t]he d
, and the r
partially
at the cut
minum …
ge” (id. a
an ampul
ed housin
ially sever
wn in dot
r to effecti
al front ed
, cut out o
all of the h
notched or
as shown
tearing the
rug charg
ounded ed
severed di
ter “eleme
[that] len
t col. 4, ll.
e showing
g and cutt
ing the di
ted lines in
vely punc
ge of the e
r serrated
ousing at
cut out, a
at 19 … [t
material
e D is ejec
ge 19 of th
aphragm in
nt 13 may
d[s] itself
23-26).
“the
er
aphragm o
the
ture or
xtension
sharply, as
the
s shown at
o] enable
or causing
ted into
e
open
be made
to the

f

Appeal 2010-009568
Application 11/294,256

6
Analysis
Claim 1 is directed to a cutting element for a retracting needle syringe,
having raised distally projecting tapered cutting teeth, with at least one tooth
edge having a sharp side wall.
As recognized by the Examiner, Caizza discloses the cutting element
of claim 1 except that it does not disclose that the cutting edge includes the
teeth recited in claim 1. Sommerstein discloses a sharply serrated cutter
element as part of an ampule or cartridge for a syringe that functions to cut
through a rubber diaphragm of the ampule to combine a drug with a solvent.
In view of the these disclosures, it would have been obvious to one of
ordinary skill in the art to modify Caizza’s cutting element to have a sharply
serrated cutting edge as described in Sommerstein because Caizza does not
disclose that any specific structure is required for the cutting edge and
Sommerstein discloses that a sharply serrated cutting edge is suitable for
efficiently cutting through rubber in a syringe.
Appellants argue that the cited references would not have made
obvious the cutting element of claim 1 because the cited art does not identify
a problem with Caizza’s cutting edge that would suggest modification
(Appeal Br. 14-15).
This argument is not persuasive. As discussed above, Caizza and
Sommerstein both disclose cutting elements for syringes, one with serrations
and one without. Thus, one of skill in the art would understand that the
sharply serrated edge of Sommerstein would also be suitable for use as an
effective sharp edge of the Caizza cutting element.
Appeal 2010-009568
Application 11/294,256

7
Appellants also argue that one of skill in the art would not apply
Sommerstein’s disclosure to Caizza’s cutting element since Sommerstein is
directed to piercing and only partially severing a diaphragm, rather than
cutting all the way through a barrier (Appeal Br. 15-16).
This argument is also not persuasive. Sommerstein discloses that its
sharply serrated edge “effectively puncture[s] or partially sever[s] the
diaphragm” (FF 9). Sommerstein discloses that part of the circumference of
the cylindrical portion of its device has a rounded edge, rather than sharp
teeth, to keep the partially severed diaphragm open while the drug is being
ejected into the vehicle (FF 11). Thus, one of skill the art would understand
that the sharply serrated leading edge of the Sommerstein cutting element is
an efficient cutting element, even if Sommerstein only intended to partially
sever the diaphragm in its device.
Finally, with respect to claim 1, Appellants argue that “the Examiner
has provided no evidence [that] the teeth on the cutting member in
Sommerstein have a sharp side wall capable of cutting a plunger” (Appeal
Br. 17). Appellants rely on the same argument with respect to the sharp side
wall or beveled edge recited in claims 2, 11-14, and 19-22 (see id. at 17-18
and 20-23).
This argument is not persuasive. Sommerstein discloses that the
leading edge of the cutting element is sharply serrated (FF 9), that it has the
function of puncturing or partially severing a diaphragm (FF 9), and that it
must be made of a material that produces an efficient cutting edge (FF 12).
Thus, it would have been obvious to make the cylindrical cutting element of
Appeal 2010-009568
Application 11/294,256

8
Sommerstein’s device with serrated edges, including the edges between the
teeth, that are sharpened; i.e., beveled to form a sharp edge.
With regard to claims 5, 7, and 8, Appellants argue that staggering the
height of the teeth or the height of the cutting edges between the teeth, as
required by these claims, is not taught by Sommerstein (Appeal Br. 18-19).
We agree with Appellants that the Examiner has not adequately
explained how the cited references would have made obvious a cutting
element with teeth, or cutting edges between the teeth, that are at different
heights. The Examiner has not pointed to anything in the references that
would have suggested staggering of the teeth or cutting edges between the
teeth, or provided any reasoning why one of skill in the art would have
considered this feature to be obvious in view of the cited references. The
Examiner’s reasoning that “it has been held to be within the general skill of
a worker in the art to select a known material on the basis of its suitability
for the intended use as a matter of obvious design choice” (Answer 5) is not
adequate to show the obviousness of these limitations. Thus, we reverse the
rejections of claims 5, 7, and 8.
Conclusion of Law
The cited references would have made obvious a retracting needle
syringe cutting element with a distal end that includes “a cutting edge and a
plurality of raised distally projecting tapered cutting teeth each having a
distal tip and distally converging edges, at least one tooth edge having a
sharp side wall for cutting” the plunger and needle support of the syringe.
Appeal 2010-009568
Application 11/294,256

9
SUMMARY
We affirm the rejection of claims 1, 2, 4, 6, and 9-22 under 35 U.S.C.
§ 103(a). However, we reverse the rejection of claims 5, 7, and 8.
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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