Ex Parte Ferreyro et al

Patent Trial and Appeal Board

Sep 27, 2013

10549409 (P.T.A.B. Sep. 27, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD

____________

Ex parte ROQUE HUMBERTO FERREYRO and
MARIO MARQUEZ MIRANDA1
____________

Appeal 2012-005343
Application 10/549,409
Technology Center 3700
____________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
SUSAN L. C. MITCHELL, Administrative Patent Judges.

MITCHELL, Administrative Patent Judge.

DECISION ON APPEAL

Appellants appeal under 35 U.S.C. § 134 from the Examiner’s
decision finally rejecting claims 8, 12, 20, 36-39, 50-51, 59, 61 and 78 as
obvious. We have jurisdiction over the appeal under 35 U.S.C. § 6(b).
We affirm.

1 Appellants identify the Real Party in Interest as DePuy Spine, Inc. (App.
Br. 2).
Appeal 2012-005343
Application 10/549,409

2

STATEMENT OF THE CASE
The Specification is directed to a hydraulic device for injection of
polymethylmethacrylate (PMMA), also known as bone cement, in
percutaneous vertebroplasty where the person administering the bone
cement is at a distance from the patient to avoid exposure to unacceptable
levels of secondary radiation (Spec. 1 ¶ [2-3], 5 ¶ [22-23]).
Claims 8, 12, 20, 36-39, 50-51, 59, 61, and 78 are on appeal, and are
set forth in a Claims Appendix to the Appeal Brief (Claims Appendix i-iii).
Claims 37 and 78, two independent claims, are illustrative of the claims on
appeal, and read as follows:
37. A method of delivering a viscous material under
fluoroscopy to a site in a patient comprising the steps of:
a) providing a delivery tube containing an incompressible
fluid and a viscous material, wherein the viscous material is
located within the fluoroscopy field and the viscous material
comprises bone cement; and
b) pressurizing the incompressible fluid outside the
fluoroscopy field to exert pressure on the viscous material.

78. A method of delivering a viscous bone cement material
under fluoroscopy to a site in a patient, comprising:
providing a delivery device having:
a container containing a viscous bone cement prior to the
bone cement having set, the container having an exit port;
an actuator having an actuator vessel, the actuator vessel
containing an incompressible fluid; and
a hydraulic coupling tube connecting the actuator vessel
to the container;
locating the container with respect to the patient so that cement
leaving the container through the exit port is delivered to a desired
injection site within the patient; and
Appeal 2012-005343
Application 10/549,409

3
while at least a portion of the patient is subjected to
fluoroscopic imaging, actuating the actuator from a location outside a
field of fluoroscopic imaging to hydraulically drive a flow of viscous
bone cement through the exit port to the desired injection site within
the patient.

The Examiner has rejected claims 8, 12, 20, 36-39, and 78 under 35
U.S.C. § 103(a) as unpatentable over Gangi2 in view of Dardik;3 claims 50
and 51 under 35 U.S.C. § 103(a) as being unpatentable over Gangi in view
of Dardik as applied to claim 37, and further in view of Nic;4 claim 59 under
35 U.S.C. § 103(a) as being unpatentable over Gangi in view of Dardik and
further in view of Haig;5 and claim 61 under 35 U.S.C. § 103(a) as being
unpatentable over Gangi in view of Dardik and further in view of
Voellmicke.6
The Examiner finds that Gangi discloses a method of delivering bone
cement under fluoroscopy to a patient using a syringe through an exit port
(Ans. 5). The Examiner notes, however, that Gangi “does not specifically
disclose[] an actuator having an actuator vessel, the actuator vessel
containing an incompressible fluid; and a hydraulic coupling tube
connecting the actuator vessel to the container; and actuating the actuator
from a location outside a field of fluoroscopic imaging to hydraulically drive
the flow” (id.). The Examiner finds that Dardik provides this missing

2 Afshin Gangi et al., Percutaneous Vertebroplasty Guided by a
Combination of CT and Fluoroscopy, 15 AM. J. NEURORADIOLOGY 83
(1994).
3 Dardik et al., US 4,250,887, issued Feb. 17, 1981.
4 Nic, US 5,431,654, issued on July 11, 1995.
5 Haig, US 4,494,535, issued Jan. 22, 1985.
6 Voellmicke et al., US 7,008,433 B2, issued March 7, 2006.
Appeal 2012-005343
Application 10/549,409

4
teaching (id. 5-6). The Examiner concludes that “[i]t would have been
obvious to someone of ordinary skill in the art at the time of the invention to
add the actuator, hydraulic coupling tube and actuation step of Dardik to the
method of Gangi in order to reduce the radiation exposure of the surgeon”
(id. 6).
Appellants assert that the prior art involved “devices such as pressure
gun type or threaded plunger mechanisms connected directly to the needle
that deposit the cement in the bone or through a high pressure short tube.
The use of a long tube would have considerable resistance to the flow of
the cement, favoring its solidification” (App. Br. 5-6 (citing Spec. 2 ¶ [9])
(emphasis in original)). Appellants solved this problem by separating the
cement injector from a mechanically advantaged actuator using hydraulic
coupling tubing (id. 6). Appellants concluded that
[i]n this way, the cement can be directly injected under
fluoroscopy while the actuator, and thus the surgeon, can be
safely outside the fluoroscopy field. In addition, the problem of
increased resistance (and attendant premature hardening) is
avoided because the cement container is located directly on the
patient and the cement does not pass through a long tube.

(App. Br. 6).
The Appellants contend that the Examiner uses impermissible
hindsight when combining Gangi and Dardik. Appellants urge that no one
of skill in the art would combine the direct, mechanically-advantaged
viscous cement injection device of Gangi with the indirect radiographic dye
injection system of Dardik because the two devices are incompatible and the
resulting combination would not be capable of injecting viscous bone
cement (App. Br. 8).
Appeal 2012-005343
Application 10/549,409

5
Appellants state that Dardik, which involves a device for injecting
radiopaque dye during intraoperative angiography, teaches that a surgeon
can maintain the “feel” of injecting dye even over a distance because
conventional force is applied to a driving fluid such as oil or water “which
might have a density and viscosity generally similar to that of the
radiopaque injectate,” and “the driven plunger . . . will drive the injectate
plunger essentially the same distance and at the same rate . . . .” (App. Br.
10 (quoting Dardik, col. 2, ll. 63-65 and col. 3, ll. 11-14, respectively)
(emphasis in original)).
Appellants conclude that:
The system of Dardik thus will not work for
vertebroplasty: because small syringes must be used for high
pressure injection, Dardik would have to use multiple small
syringes to inject viscous bone cement; Dardik uses a lengthy
tube to the patient (which would cause viscous bone cement to
resist injection and harden in the tubing); would not (because of
its express teaching regarding “feel”) would not apply a
mechanical advantage to inject the viscous bone cement; and
would lead to the use of viscous bone cement as a “hydraulic
fluid” because of its express teachings regarding using a fluid
of similar and viscosity to that being injected. Curing any one
of these problems would violate the express teachings of
Dardik.

(App. Br. 11).
The issue presented is: Does the preponderance of evidence of record
support the Examiner’s conclusion that one of ordinary skill in the art would
have been led to separate the container or delivery tube for injecting bone
cement into a patient from a pressurizing mechanism such as an actuator
Appeal 2012-005343
Application 10/549,409

6
with a hydraulic coupling tube given the teachings of Gangi and Dardik to
remove the surgeon from exposure to radiation?
A. Findings of Fact
FF 1. Gangi teaches a technique of percutaneous vertebroplasty to
prevent vertebral body collapse using methyl methacrylate under the
guidance of fluoroscopy and computed tomography (CT) (Gangi, 83).
FF 2. Gangi teaches using CT to guide the needle into the optimal
position of placing the needle tip in the anterior third of the vertebral body
(id.).
FF 3. Gangi teaches using fluoroscopy to inject 4-8ml of methyl
methacrylate during its pasty polymerization phase using a 2-ml Luer Lock
syringe mounted on a pressure regulator to facilitate injection of the viscous
cement (id. 84).
FF 4. Gangi teaches that injection of the cement may be
“immediately stopped whenever an epidural or paravertebral opacification
was observed to prevent spinal cord compression” (id.).
FF 5. Dardik teaches an apparatus for injecting a radiopaque dye into
an artery of a patient during intra-operative arteriography (IOA) “that
permits the surgeon to have the benefits of conventional, manual injection in
the immediate proximity of the patient during IOA, while he is actually at a
remote location and behind lead-lined walls and safe from radiation”
(Dardik, col. 1, ll. 6-9, and col. 2, ll. 42-47).
FF 6. Dardik specifically teaches a preferred embodiment described
as follows referring to Figures 2 and 3 reproduced below:
App
App

eal 2012-0
lication 10
A
embodim
hydrauli
fluid [35
viscosity
The con
conventi
[35] in th
situated
second,
oriented
syringe’
the drive
remote e
Th
driven sy
axial and
the drive
plunger
moved a
same dis
normally
compon

05343
/549,409
s illustrate
ent comb
c conduit
] such as w
generally
duit has a
onal-type
e conduit
very near
driven syri
opposite t
s plunger [
syringe [2
nd.
e inventio
ringe barr
fixed rela
n syringe
[26]. Whe
xially, wil
tance and
, this coup
ent.
d [above i
ines with a
[33], prefe
ater or oi
similar to
first end in
syringe [2
in the dire
the syringe
nge [34] i
he drive sy
38] is driv
2] is oper
n further i
el [37] an
tionship,
plunger [3
n so coup
l drive the
at the sam
ling also p
7
n Figures 2
n injectat
rably flexi
l, which m
that of the
the radiat
2] for driv
ction of th
containin
s connecte
ringe [22]
en outwar
ated to for
ncludes a
d injectate
and a coup
8] with th
led the driv
injectate p
e rate in an
ermits rev
and 3] a
e syringe [
ble hose c
ight have
radiopaq
ion-safe ar
ing the hy
e remote
g injectate
d to the re
, whereby
d of the ba
ce fluid to
fixture for
syringe ba
ling [47] f
e injectate
en plunge
lunger es
ideal hyd
erse mov
preferred
24], a
ontaining
a density a
ue injectat
ea with a
draulic flu
end which
[24]; a
mote end,
the driven
rrel [37] w
ward the
holding th
rrel [25] i
or engagin
syringe
r, when
sentially th
raulic sys
ement of th
a
nd
e.
id
is
but

hen
e
n an
g
e
tem;
e

Appeal 2012-005343
Application 10/549,409

8
(Id., col. 2, l. 61 through col. 3, l. 15; see also id., col. 3, l. 67 through
col. 4, l. 53 (describing numbered references in Figure 2).
FF 7. Dardik teaches that the adaptor [29] could directly receive the
injection needle [28] obviating the need for tube [27] (id., col. 4, ll. 1-3).
FF 8. In describing the use of the apparatus as having “conventional
force and feel,” Dardik teaches that “[m]odifications may be made if
necessary in the dimensions of the drive and driven syringes and
intermediate hose filled with fluid, to be sure they simulate closely the feel
of direct manual injection of radiopaque dye, in regard to the mass and
viscosity of the dye and the force to discharge same” (id., col. 2, l. 53 and
col. 3, ll. 19-24).
FF 9. Dardik teaches that controlled remote injection may be
achieved with an imperfect hydraulic system (id., col. 5, ll. 23-25).
FF 10. Dardik also teaches that “the drive and driven syringes and
intermediate hose could be replaced with any fluid conduit having a drive
piston at the near end and a driven piston at the remote end” (id., col. 5, ll. 8-
11).
FF 11. Appellants teach that their hydraulic device for injection of
bone cement in percutaneous vertebroplasty works in the following way as
depicted in Figure 1 reproduced below.
Appeal 2012-005343
Application 10/549,409

9

[Figure 1 shows that] a manual force is exercised on the
plunger (9) of the manual syringe (8) in its extended position,
the force exercises a pressure that is transmitted through the
incompressible fluid (10) content in the flexible tube and in the
camera (5) of the body of pressure (1). This pressure exercises
an increased force on the plunger of the injecting syringe, due
to the mechanical advantage . . . . The plunger of the injecting
syringe in turn, exert[s] a force that impels . . . the material or
cement to be injected in the patient’s vertebral body through the
bone biopsy needle. Once the total amount or content of the
injecting syringe has been delivered, the plunger of the manual
syringe is retracted to generate space inside the body of
pressure (1) by retracting the piston to replace the emptied
syringe with a loaded new syringe to continue the injection. Up
to 10 ml. of bone cement is required to achieve [a] suitable
filling of the fractured vertebral body, therefore, 3 to 4 syringe
exchanges may be necessary.

(Spec. 11, ¶ 0057).

Appeal 2012-005343
Application 10/549,409

10
FF 12. Appellants also teach in reference to Figure 1 that
[t]he injection part is a commercially available, disposable 3 ml.
hypodermic syringe (a) that is placed next to the patient, loaded
with bone cement that consists of a plunger (11) that pushes the
material (CO) to be injected in the vertebral body trough a bone
needle (CA), (not shown). . . . The injection needle is coupled
rotating the threaded distal end (CA) in the usual way of
common plastic syringes in order to avoid spillage of the
material to be injected due to the high pressure exercised on the
plunger (c) and its end (3).

(Spec. 9-10, ¶ 0053).
FF 13. Appellants teach that the invention has “a better control of the
pressure in the placement of bone cement or other viscous materials in the
bone” (Spec. 5, ¶ 0021), that a surgeon can manually control the volume and
velocity of the injection of bone cement and immediately interrupt the
pressure applied on the fluid (id. 6, ¶ 0026), and that in using the invention,
“the fingers of the operator exercise the controlled force. This control is
carried out by the operator’s tact sensitivity” (id. 9, ¶ 52).
FF 14. Appellants teach that an advantage of the invention “is that the
transmission of the pressure is immediate, that is to say, doesn’t have a
dynamic memory by effects of the increasing viscosity due to the
solidification in the injection conduit . . . ” (id. 11, ¶ 59).
B. Analysis
Appellants challenge the Examiner’s prima facie case of obviousness
for the claims at issue. A claim is generally obvious when it is merely “[t]he
combination of familiar elements according to known methods” that “does
no more than yield predictable results.” KSR Int’l v. Teleflex Inc., 550 U.S.
398, 416 (2007); see also Sakraida v. AG Pro, Inc., 425 U.S. 273, 282
Appeal 2012-005343
Application 10/549,409

11
(1976) (finding that when a patent “simply arranges old elements with each
performing the same function it had been known to perform” and yields no
more than one would expect from such an arrangement, the combination is
obvious). “Under the correct [obviousness] analysis, any need or problem
known in the field of endeavor at the time of invention and addressed by the
patent can provide a reason for combining the elements in the manner
claimed.” KSR, 550 U.S. at 402 (emphasis added).
Both independent claims 37 and 78 are generally directed to
delivering bone cement to a desired location in a patient such as a diseased
vertebral body using a delivery tube or container for the viscous bone
cement that is located within a fluoroscopy field coupled with a hydraulic
tube containing an incompressible fluid that is pressurized with an actuator
outside of the fluoroscopy field to deliver the bone cement (Claims
Appendix i-iii). We agree with the Examiner that the combination of the
teachings of Gangi and Dardik would have rendered these claims obvious
one of skill in the art.
Gangi teaches using fluoroscopy to inject bone cement into a vertebral
body by a syringe mounted on a pressure regulator (FF 1-3). As the
Examiner explained, Dardik teaches separating an injector with viscous
material, radiopaque dye, from a hydraulic actuator by a hydraulic tube.
(See Ans. 2) (finding Dardik teaches “providing an actuator 22 having an
actuator vessel, the actuator vessel containing an incompressible fluid 35;
and a hydraulic coupling tube 33 connecting the actuator vessel to a
container 25; and actuating the actuator from a location outside a field of
radiation to hydraulically drive the flow of the viscous material from the
Appeal 2012-005343
Application 10/549,409

12
container (Fig. 1; Dardik, col. 2, l. 61 to col. 3, l. 15)”); see also FF 6. One
of skill in the art would have been motivated to combine the teachings of
these two references to solve the problem of unwanted radiation exposure of
the surgeon (Reply Br. 2 (citing Spec. 2, ¶ 9)).
Appellants’ contention that one of skill in the art would not have
combined Gangi with Dardik is unpersuasive. Appellants assert that Dardik
teaches injecting radiopaque die that has a viscosity similar to water rather
than the highly viscous bone cement (App. Br. 5, 10-11; Reply Br. 4-5). A
reference, however, teaches all that would have reasonably been suggested
to one having ordinary skill in the art. Merck & Co. v. Biocraft Labs., Inc.,
874 F.2d 804, 807-08 (Fed. Cir. 1989); see also In re Heck, 699 F.2d 1331,
1332-33 (Fed. Cir. 1983). While Dardik does not teach the use of bone
cement in its apparatus, it does teach separating the injector with a viscous
material from a hydraulic actuator by a hydraulic tube to prevent secondary
radiation exposure of the surgeon (FF 5-6). Dardik also teaches that
adjustments may be made to the system to accommodate more viscous fluids
to achieve a similar “feel” to direct injection, which is also taught by
Appellants in describing their invention. Compare FF 8 (Dardik explaining
that the dimensions of the drive and driven syringes, as well as the hydraulic
tube connecting them may be adjusted to accommodate the mass and
viscosity of the fluid and the force necessary to discharge it)) with FF 13
(Appellants describing “the fingers of the operator exercise the controlled
force” using “the operator’s tact sensitivity” in their invention).
Appellants further assert that combining Gangi with Dardik involves
using impermissible hindsight. We disagree. Gangi teaches how to inject
Appeal 2012-005343
Application 10/549,409

13
bone cement into a vertebral body while Dardik offers a solution to remove a
surgeon from the radiation field by separating the injector from the actuator
with a hydraulic tube. As the Examiner stated, the rejection relied “on
Dardik for the concept of reducing the radiation exposure of the surgeon by
using an actuator, hydraulic coupling tube outside of the area” and “it would
have been obvious to someone of ordinary skill in the art at the time of the
invention to add the actuator, hydraulic coupling tube and actuation step of
Dardik to the method of Gangi in order to reduce the radiation exposure of
the surgeon” (Ans. 8). The fact that Dardik does not teach the use of bone
cement specifically is irrelevant; Gangi provides this teaching.
Appellants argue that when viewed in light of more relevant prior art
such as Al-Assir7 and Preissman,8 the claimed invention would not have
been obvious because Al-Assir and Preissman teach away from the
invention. Appellants assert that both references teach away because they
solved the identical problem of radiation exposure of the surgeon in a
different way by providing mechanically-advantaged injection of bone
cement through an elongated tube or needle. (App. Br. 9-15; Reply Br. 2-4).
A reference teaches away when it discourages one of skill in the art from
following the teaching in the reference or leads the artisan in a different
direction than the claimed invention. In re Gurley, 27 F.3d 551, 553 (Fed.
Cir. 1994). “The degree of teaching away will of course depend on the
particular facts; in general, a reference will teach away if it suggests that the
line of development flowing from the reference’s disclosure is unlikely to be

7 Al-Assir, US 6,676,664 B1, issued Jan. 13, 2004.
8 Preissman, US 6,383,190 B1, issued May 7, 2002.
Appeal 2012-005343
Application 10/549,409

14
productive of the result sought by the applicant.” Id. Appellants assert that
Al-Assir and Pressman would teach away from using the system of Dardik
wherein the driving fluid is similar in viscosity to the delivered fluid (App.
Br. 12-13 (“Al-Assir’s goal is not to improve upon Dardik, but to replace it
entirely with a system that handles higher pressures and larger volumes.”
Preissman “makes this point even more strongly, noting the desirability of
high viscosity cements and the many problems involved with injecting them
through conventional syringes”)).
Appellants are comparing prior art to another piece of prior art to
show teaching away. What Appellants must do to show a teaching away,
however, is to compare the teachings of the prior art to the claimed
invention. Appellants, however, have pointed to nothing in either Al-Assir
or Preissman that would discourage the Appellants from separating the
injector with the viscous cement from a hydraulic actuator by a hydraulic
tube. The fact that Al-Assir and Preissman solved the problem of secondary
radiation exposure of the surgeon in a different way than the Appellants does
not constitute a teaching away. See In re Fulton, 391 F.3d 1195, 1201 (Fed.
Cir. 2004) (“‘[T]he question is whether there is something in the prior art as
a whole to suggest the desirability, and thus the obviousness, of making the
combination,’ not whether there is something in the prior art as a whole to
suggest that the combination is the most desirable combination available.”)
(quoting In re Beattie, 974 F.2d 1309, 1311 (Fed. Cir. 1992) (citation
omitted)).
Appellants also contend that Dardik is non-analogous art because
“Dardik deals in a different field of endeavor, and no person of ordinary skill
Appeal 2012-005343
Application 10/549,409

15
in the art would logically look to a device that injects fluids having the
consistency of water in order to inject viscous bone cement” (App. Br. 18).
Appellants’ argument is misplaced. To be analogous, a piece of prior art
“must either be in the field of the applicant’s endeavor or, if not, then be
reasonably pertinent to the particular problem with which the inventor was
concerned.” In re Oetiker, 977 F.2d 1443, 1447 (Fed. Cir. 1992). As the
Examiner correctly concluded, “Dardik teaches an injecting system for
flowable materials, therefore, the prior art of Dardik is an analogous art
since Gangi teaches a device for delivering flowable bone cement” (Ans. 8).
The evidence supports the Examiner’s conclusion that claims 37 and 78
would have been obvious.
Appellants argue that dependent claim 20 is independently patentable
because the “teachings of [Dardik, Preissman, and Al-Assir] are inconsistent
with claim 20, which requires that the injection needle is connected to the
exit port for delivery of the viscous material to the injection site” (App. Br.
20). The Examiner correctly finds, however, that Dardik shows such a
connection; “Dardik shows that the needle is connected to the syringe via
tube (27)” (Ans. 9). The Examiner also correctly notes that the requirement
for a direct connection between the syringe and the bone needle is not a
limitation of claim 20 (id.). In any event, Dardik teaches that teaches that
the adaptor [29] could directly receive the injection needle [28] obviating the
need for tube 27 (FF 7). The evidence supports the conclusion that claim 20
is obvious.
Appellants also argue that independent claim 51 is separately
patentable because Dardik teaches away from “applying force amplification
Appeal 2012-005343
Application 10/549,409

16
on the incompressible fluid by mechanical advantage,” the additional claim
limitation added to claim 37 by claim 51 (Claims Appendix ii). Appellants
assert that Dardik teaches allowing the surgeon to maintain the same “feel”
of injecting dye directly into a patient while preventing radiation exposure
(App. Br. 21). This teaching, however, does not suggest “that the line of
development flowing from the reference’s disclosure is unlikely to be
productive of the result sought by the applicant.” In re Gurley, 27 F.3d at
553. In fact, Appellants assert that their invention also uses the operator’s
tact sensitivity to control the injection of bone cement (FF 13) and that the
transmission of pressure is immediate (FF 14), which suggests Appellants’
claimed invention provides for the “feel” of direct injection. The evidence
supports the conclusion that claim 51 is also obvious.
C. Conclusion of Law
The evidence supports that Examiner’s conclusion that claims 20, 37,
51, and 78 are obvious. Because Appellants do not argue the claims
separately in their appeal brief, claims 8, 12, 36-39, 50, 59, and 61 fall with
claims 37 and 78. 37 C.F.R. § 41.37(c)(1)(vii).

SUMMARY
We affirm the rejection of claims 8, 12, 20, 36-39, and 78 under 35
U.S.C. § 103(a) as unpatentable over Gangi in view of Dardik; claims 50
and 51 under 35 U.S.C. § 103(a) as being unpatentable over Gangi in view
of Dardik as applied to claim 37, and further in view of Nic; claim 59 under
35 U.S.C. § 103(a) as being unpatentable over Gangi in view of Dardik and
further in view of Haig; and claim 61 under 35 U.S.C. § 103(a) as being
Appeal 2012-005343
Application 10/549,409

17
unpatentable over Gangi in view of Dardik and further in view of
Voellmicke.

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED

lp