Ex Parte Silverman et al

Patent Trial and Appeal Board

Sep 16, 2013

12014741 (P.T.A.B. Sep. 16, 2013)

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.
12/014,741 01/15/2008 David E. Silverman 02-241US18 (4010/383C4) 1115
106953 7590 09/16/2013
Mayer & Williams
251 North Avenue West
Suite 201
Westfield, NJ 07090
EXAMINER
GILBERT, SAMUEL G
ART UNIT PAPER NUMBER
3735
MAIL DATE DELIVERY MODE
09/16/2013 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DAVID E. SILVERMAN and ALAN STEIN
__________

Appeal 2012-002324
Application 12/014,741
Technology Center 3700
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 involving claims
directed to an apparatus or kit for administering a biocompatible polymer to
a patient. The Patent Examiner has rejected the claims for obviousness. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellants identify the Real Party in Interest as Boston Scientific Scimed,
Inc. (App. Br. 2.)
Appeal 2012-002324
Application 12/014,741

2
STATEMENT OF THE CASE
The Specification provides a method of treating fecal incontinence by
injecting “an implantable material such as an implant-forming material or
solution is introduced into rectal wall . . . in the vicinity of anal sphincter . . .
by any suitable means to augment, bulk or otherwise decrease the
distensibility of the anal sphincter.” (Spec., p. 3, ll. 15-18.) Appellants’
claims are directed to an apparatus or kit comprising a syringe, needle, and
stopcock for the administration of an implant.
Claims 26-58 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief (App. Br. 11-14). Claims 26, 36, 43, and 51 are
independent claims directed to either an apparatus or a kit. Claim 26 is
illustrative of the claims on appeal, and reads as follows:
26. An apparatus for treating a wall forming the lower
portion of the gastrointestinal tract in a body of a mammal
comprising a syringe, a rigid needle coupleable to the syringe,
and a stop cock disposable between the syringe and the needle
for permitting selective supply of solution to the needle, the
syringe including a reservoir of a solution of a biocompatible
polymer and a biocompatible solvent for forming a
nonbiodegradable implant in the wall.
The Examiner has rejected the claims as follows:
1. claims 26-31 and 35 under 35 U.S.C. § 103(a) as being
unpatentable over Wallace2 in view of Dykstra,3 and Strauss;4
2. claim 32 under 35 U.S.C. § 103(a) as being unpatentable over
Wallace, Dykstra, and Strauss and further in view of Silverstein;5

2 George Wallace et al., US 5,755,658, issued May 26, 1998.
3 Dennis D. Dykstra et al., US 4,932,936, issued Jun. 12, 1990.
4 Harry W. Strauss et al., US 4,471,765, issued Sep. 18, 1984.
Appeal 2012-002324
Application 12/014,741

3
3. claim 33 under 35 U.S.C. § 103(a) as being unpatentable over
Wallace, Dykstra, and Strauss and further in view of Brown;6
4. claims 36-38 and 42 under 35 U.S.C. § 103(a) as being
unpatentable over Wallace, Dykstra, and Strauss and further in view of
Grubbs;7
5. claim 39 under 35 U.S.C. § 103(a) as being unpatentable over
Wallace, Dykstra, Strauss, and Grubbs and further in view of Silverstein;
6. claim 40 under 35 U.S.C. § 103(a) as being unpatentable over
Wallace, Dykstra, Strauss and Grubbs and further in view of Brown;
7. claims 43-48 and 50 under 35 U.S.C. § 103(a) as being
unpatentable over Wallace, Dykstra, and Strauss and further in view of
Beddow8 or Howson;9
8. claims 51-56 and 58 under 35 U.S.C. § 103(a) as being
unpatentable over Wallace, Dykstra, Grubbs, and Strauss and further in view
of Beddow or Howson.

ISSUE
We consider the rejections together because the same issue is
dispositive with respect to claims 26-34, 36-41, 43-59, and 51-57 (see App.
Br. 4: “Each of the Examiner's rejections hinges on the combination of
Wallace Dykstra and Strauss;” and 8: “The remaining references cited by
the Examiner (Silverstein, Brown, Grubbs, Beddow, Howson), do not make

5 Fred E. Silverstein et al., US 5,193,525, issued Mar. 16, 1993.
6 Frank E, Brown et al., US 2,648,334, issued Aug. 11, 1953.
7 Robert H. Grubbs et al., US 4,919,151, issued Apr. 24, 1990
8 David V. Beddow, US 4,226,328, issued Oct. 7, 1980.
9 David C. Howson, US 4,722,733, issued Feb. 2, 1988.
Appeal 2012-002324
Application 12/014,741

4
up for the above-noted deficiencies in the combination of Wallace, Dykstra
and Strauss.”)
The Examiner finds that Wallace teaches a method of delivering a
polymer into the tissue of a mammal. “The material is injected into the
body . . . but the means to inject the material is not set forth. Dykstra
teaches a cystoscopic device for injecting material into the body wherein the
injection means is a syringe.” (Ans. 5.) The Examiner concludes that it
would have been obvious “to use a syringe as taught by Dykstra for the
injection means of Wallace as a selection of a specific known injection
means from all known injection means.” (Ans. 5.) The Examiner concedes
that “the combination of Wallace and Dykstra does not teach a stop cock.”
(Ans. 6.) The Examiner looks to Strauss for teaching the use of a stop cock
in conjunction with syringes and a catheter, concluding that it is obvious to
insert a “stop cock positioned between the syringe and the needle to allow
the stop cock to be closed and opened to ensure that the material in the
syringe is timely delivered.” (Ans. 6.)
The issue is: Does the evidence of record support the Examiner’s
conclusion that Wallace, Dykstra, and Strauss render obvious the apparatus
or kit as claimed in independent claims 26, 36, 43, and 51?

FINDINGS OF FACT
FF1. Wallace disclosed introducing a biocompatible polymer into a
mammal “via conventional catheter or needle technology using, for example.
cystoscopic techniques. Specifically, the injection may be performed
through a puncture needle or spinal needle placed directly through the
cystoscope or periurethrally with a spinal needle placed percutaneously at
App
App

the i
col.

whic
bioc
need
need

“ethy
solut
weig
to or

from
base
agen

of m
relev
eal 2012-0
lication 12
ntroitus an
7, ll. 57-63
FF 2. W
h is a poly
ompatible
le selected
le.” (Wal
FF 3. W
lene viny
ion of 6 w
ht percent
less than
FF 4. W
about 2.5
d on the to
t and bioc
FF 5. D
edication i
ant portio
02324
/014,741
d position
; Ans. 5.)
allace disc
meric com
solvent an
from the
lace, col. 4
allace dis
l alcohol c
eight perc
of a tantal
60 centipo
allace disc
to about 8
tal weight
ompatible
ykstra dis
nto muscl
n of Figure
ed in the ti
losed “a k
position c
d a contra
group sele
, ll. 45-51
closed a b
opolymer
ent of the
um contra
ise at 20°
losed that
.0 weight
of the pol
solvent.”
closed a n
e tissue su
1 is repro
5
ssue adjac
it of parts
omprising
st agent; an
cted of a p
; Ans. 5.)
iocompatib
compositio
ethylene v
st agent in
C.” (Wall
“the polym
percent of
ymer com
(Wallace,
eedle/elect
rrounding
duced bel
ent to the
comprisin
a biocom
d a secon
uncture ne
le polyme
n is selec
inyl alcoh
DMSO h
ace, col. 6
er compo
the biocom
position, in
col. 7, ll. 7
rode assem
the urethr
ow:
urethra.”
g: a first m
patible po
d member
edle and s
r compris
ted such th
ol copolym
as a viscos
, ll. 10-14.
sition wil
patible p
cluding c
-11; Ans.
bly for th
al sphincte
(Wallace,
ember
lymer, a
which is a
pinal
ing
at a
er, 35
ity equal
)
l comprise
olymer
ontrast
6.)
e injection
r. The

App
App

Figu
beve
(Dyk
can b

injec
col.

sphin
chan
need
sphin

repro
“The
shut
selec
syrin
eal 2012-0
lication 12
re 1 shows
led distal e
stra, col. 2
e soldered
FF 6. D
ted throug
3, ll. 14-15
FF 7. D
cter visua
nel of the
le 32 is po
cter. (Dy
FF 8. Str
duced bel
valve 10,
off both sy
tively ope
ges 12 or
02324
/014,741
a “needle
nd 34 and
, ll. 56-58
to the ne
ykstra dis
h needle/e
.)
ykstra dis
lly located
cystoscope
sitioned in
kstra, col.
auss discl
ow, shows
such as a
ringes 12
n commun
20. “ (Stra
/electrode
a proxim
.) The Lu
edle 32. (I
closed tha
lectrode 3
closed tha
, the need
and guid
the skele
3, ll. 31-4
osed the u
two syrin
4-way stop
and 20 fro
ication be
uss, col. 3
6
30 that in
al end 36 t
erlock hub
d. at ll. 59
t “[t]oxin s
0 by mean
t the cysto
le electrod
ed visually
tal muscle
2.)
se of a stop
ges engag
cock, is a
m commu
tween cath
, ll. 20-24
cludes a ne
hat is conn
38 can be
-62.)
uch as Bo
s of a syri
scope 46 i
e is inserte
until the
tissue surr
cock with
ed with th
dapted to
nication w
eter 14 an
.)
edle 32 w
ected to a
stainless
tulinum A
nge 48.” (
s inserted
d into the
distal tip 3
ounding t
a syringe
e stopcock

20 be posi
ith cathet
d either on
ith a sharp
hub 38.”
steel and
can be
Dykstra,
and the
working
4 of the
he
. Figure 1
.
tioned to
er 14 or to
e of

,

Appeal 2012-002324
Application 12/014,741

7
PRINCIPLES OF LAW
“[T]he patentability of apparatus or composition claims depends on
the claimed structure, not on the use or purpose of that structure.” Catalina
Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir.
2002). “[A]pparatus claims cover what a device is, not what a device does.”
Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed.
Cir. 1990).

ANALYSIS
We are not persuaded by Appellants’ contention that the polymer
bulking injection solution of Wallace is far different in nature “than injecting
a solution of botulinum A toxin like that of Dykstra” (App. Br. 6, see also
Reply Br. 3). We are also not persuaded by Appellants’ contention that the
“polymer bulking solution is simply injected into the urethra” and, therefore,
there would be no reason to add a stop cock to the needle and syringe
apparatus (App. Br. 8).
The claims are directed to either an apparatus or to a kit. The
structure of the apparatus is made up of “a syringe, a rigid needle coupleable
to the syringe, and a stop cock disposable between the syringe and the
needle for permitting selective supply of solution to the needle.” The
Examiner found that Wallace taught injecting a biocompatible bulking
implant into tissue, specifically, into tissue adjacent to the urethra (FF 1).
The Examiner found that Dykstra also teaches the injection of medicine into
muscle tissue surrounding the urethral sphincter (FF 5). We agree with the
Examiner’s conclusion that “[t]he combination would produce expected
Appeal 2012-002324
Application 12/014,741

8
results of an apparatus for injecting the material through a cytoscope
wherein the injection means is a syringe” (Ans. 5-6).
“In determining whether obviousness is established by combining the
teachings of the prior art, the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.” In re
GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations
omitted). We agree with the Examiner that the combination of Wallace and
Dykstra suggests injecting a biocompatible implant material into muscle
tissue for the purpose of bulking the muscle tissue at the injection site. In
Wallace the biocompatible implant “compresses the urethra thereby
preventing or reducing the involuntary leakage of urine from the bladder.”
(Wallace, col. 1, ll. 21-21.) The Examiner concludes that “[t]he combination
would produce expected results of an apparatus for injecting the material . . .
[using a] syringe” (Ans. 5-6). We agree with the Examiner’s position that
the technique of injecting a substance through a needle into a muscle can be
obviously applied to other liquid substances.
As acknowledged by the Examiner, the combination of Wallace and
Dykstra does not teach a stopcock (Id. at 6). The Examiner, nevertheless,
found it obvious to use “a stop cock positioned between the syringe and the
needle to allow the stop cock to be closed and opened to ensure that the
material in the syringe is timely delivered” (Id.).
We are not persuaded by Appellants’ suggestion that the prior art
needs to expressly disclose the same reasons or advantages for making the
combination, in this case the “timely delivery” of the material as suggested
by the Examiner (Reply Br. 4), and that without such advantages “one of
ordinary skill in the art would have no reason to use the 4-way stopcock of
Appeal 2012-002324
Application 12/014,741

9
Strauss in the hypothetical device constructed by the Examiner based on
Wallace and Dykstra” (App. Br. 8).
Here, the Examiner has articulated a reason to add a stopcock to the
combination of needle and syringe, specifically, “to ensure that the material
in the syringe is timely delivered” (Ans. 6). Appellants point to no clear or
specific evidence suggesting that it was unreasonable for the Examiner to
infer that an ordinary artisan would have considered it desirable to include
that functionality on Wallace’s device. As recognized by the Supreme
Court, the obvious analysis “need not seek out precise teachings directed to
the specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” KSR Int’l. Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007). Thus, Appellants’ contention (Reply Br. 4) that the stated purpose
must be disclosed in the references is not persuasive.
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that the combination of Wallace,
Dykstra and Strauss renders obvious the apparatus of claim 26. We thus
affirm the rejection of claim 26 under 35 U.S.C. § 103(a) as being obvious.
Appellants acknowledge that claims 27-34, 36-41, 43-49, and 51-57 depend
on the combination of Wallace, Dykstra, and Strauss and they fall with claim
26 (App. Br. 8), we affirm the rejection as to those claims as well.
With respect to claims 35, 42, 50, and 58, the Examiner takes the
position that:
Strauss teaches a plurality of reservoirs connected to a needle
via a stop cock to provide controlled delivery of at least two
different materials. It would have been obvious to one of
ordinary skill in the medical arts at the time the invention was
Appeal 2012-002324
Application 12/014,741

10
made to provide the combination with a plurality of reservoirs
(syringes) and a stop cock as taught by Strauss with the
combination to provide a device capable of controlling delivery
of multiple materials as set forth by Strauss.
(Ans. 7, 9, 12, 14.)
Appellants contend that the prior art does not disclose the Examiner’s
alleged advantage that a “closed stop cock prevents injection of material if
the syringe is accidentally pressurized . . . [and] one of ordinary skill in the
art would have no reason to use the complex 4-way stopcock of Strauss in
the hypothetical device constructed by the Examiner based on Wallace and
Dykstra.” (App. Br. 9.)
We are not persuaded. As discussed above, we agree with the
Examiner that an ordinary artisan would have considered a stopcock to be
useful for assisting the accurate and timely delivery of Wallace’s polymer
solution. As also discussed above, the rationale for modifying the prior art
can be based on reasonable inferences an ordinary artisan would make.
KSR, 550 U.S. at 418.
Thus, as Appellants’ arguments do not persuade us that the
preponderance of the evidence of record fails to support the Examiner’s
conclusion that the combination of Wallace, Dykstra, and Strauss renders
obvious the additional reservoir of claims 35, 42, 50, and 58, we affirm the
rejection of claim 35, 42, 50, and 58 under 35 U.S.C. § 103(a) as being
obvious.

SUMMARY
We affirm the rejection of claims 26-31 and 35 under 35 U.S.C.
§ 103(a) over Wallace in view of Dykstra and Strauss.
Appeal 2012-002324
Application 12/014,741

11
We affirm the rejection of claim 32 under 35 U.S.C. § 103(a) over
Wallace, Dykstra, and Strauss and further in view of Silverstein.
We affirm the rejection of claim 33 under 35 U.S.C. § 103(a) over
Wallace, Dykstra, and Strauss and further in view of Brown.
We affirm the rejection of claims 36-38 and 42 under 35 U.S.C.
§ 103(a) over Wallace, Dykstra, and Strauss and further in view of Grubbs.
We affirm the rejection of claim 39 under 35 U.S.C. § 103(a) over
Wallace, Dykstra, Strauss, and Grubbs and further in view of Silverstein.
We affirm the rejection of claim 40 under 35 U.S.C. § 103(a) as being
unpatentable over Wallace, Dykstra, Strauss and Grubbs and further in view
of Brown.
We affirm the rejection of claims 43-48 and 50 under 35 U.S.C.
§ 103(a) as being unpatentable over Wallace, Dykstra, and Strauss and
further in view of Beddow or Howson.
We affirm the rejection of claims 51-56 and 58 under 35 U.S.C.
§ 103(a) over Wallace, Dykstra, Grubbs, and Strauss and further in view of
Beddow or Howson.

AFFIRMED

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