Ex Parte 7226481 et al

Patent Trial and Appeal Board

Aug 21, 2015

95002179 (P.T.A.B. Aug. 21, 2015)

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.
95/002,179 09/11/2012 7226481 3110.13REX01 4985
38846 7590 08/21/2015
Carlson, Caspers, Vandenburgh, Lindquist &
Schuman, PA
225 South 6th Street
Suite 4200
Minneapolis, MN 55402
EXAMINER
DAWSON, GLENN K
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
08/21/2015 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
____________________

GLOBUS MEDICAL, INC.
Requester, Respondent

v.

SPINEOLOGY INC.
1

Patent Owner, Appellant
____________________

Appeal 2015-002936
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Patent US 7,226,481 B2
2

Technology Center 3900
____________________

Before STEVEN D.A. McCARTHY, DANIEL S. SONG and
BRETT C. MARTIN, Administrative Patent Judges.

SONG, Administrative Patent Judge

DECISION ON APPEAL

1
Spineology Inc. is the Patent Owner and the real party in interest (Appeal
Brief of Patent Owner (hereinafter "App. Br.") 1-1). We note the
unconventional page numbering in the Patent Owner's Appeal Brief.
2
Patent US 7,226,481 B2 (hereinafter "the ’481 patent") issued June 5, 2007
to Kuslich.
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STATEMENT OF THE CASE
Claims 1–20 are subject to reexamination, claims 4–20 having been
added during the reexamination (App. Br. 3-1; Right of Appeal Notice
3

(hereinafter "RAN") PTOL-2066). Each of claims 1–20 stands rejected
(RAN 1). The Patent Owner appeals under 35 U.S.C. §§ 134(b) and 315
from the Examiner's rejections with respect to all of the rejected claims
(App. Br. 3-1). We have jurisdiction under 35 U.S.C. §§ 134(b) and 315.
In addition to its Appeal Brief and Rebuttal Brief (hereinafter "Reb.
Br."), the Patent Owner also relies on two declarations of James H. Maxwell,
M.D. in support of its appeal. The Requester relies on its Respondent Brief
(hereinafter "Resp. Br.") and two declarations of F. Calame Sammons, M.D.
in support of the Examiner's rejections. An oral hearing with the
representatives of the parties was held on July 8, 2015.
We AFFIRM-IN-PART.

THE INVENTION
The ’481 patent is directed to a method of treating the spine using a
catheter to deliver an expandable container into a vertebra, and inflating the
same with fill material (Abs.; col. 3, ll. 44–61; col. 4, ll. 32–41; Figs. 2, 4).
Independent claims 1–3, 5 and 8 read as follows (Claims App., emphasis
added):
4

3
The Examiner's Answer incorporates the RAN by reference. Hence we cite
to the RAN herein.
4
The Claim Appendix provided with the Patent Owner's Appeal Brief
includes non-admitted amendments therein, which is prohibited. See 37
C.F.R. §41.67(c)(2). The amended version of claim 5 in the Claim
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1. A method of treating an [sic, a] vertebral body
comprising the steps of:
inserting a container into an [sic, a] vertebral body;
said container having a fill passage coupled to said
container;
said container having a porous outer membrane
sufficiently porous to allow filler material under pressure to
leave the container after filling the container;
deploying said container within said vertebral body[;]
injecting a filler material into said container through said
fill passage with bone filler material in a sufficient volume to
allow the bone filler material to exit the container and
interdigitate with cancellous bone within said vertebral body
thereby reinforcing said bone and stabilizing fractures in said
bone;
said container membrane porosity sufficient to provide
resistance to the flow of said bone filler material to generate
force to move the end plates of said vertebral body.

2. A method of treating an [sic, a] vertebral body having a
superior end plate and an inferior end plate, comprising the
steps of:
inserting a container into an [sic, a] vertebral body;
deploying said container within said vertebral body;
injecting a bone filler material into said container under
pressure;
whereby said pressure supplies a distraction force to
move said superior and inferior end plates apart;
ending injection after said end plates have moved apart.

3. A method of treating an [sic, a] vertebral body
comprising the steps of:
creating a cavity in the vertebral body through an access
aperture;
inserting a container into said vertebral body;

Appendix also contains grammatical and typographical errors. Claim 5 from
the record in its unamended form is reproduced herein.
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said container having a fill passage coupled to said
container;
deploying said container within said vertebral body;
injecting a bone filler material into said container through
said fill passage.

5. The method of claim 1, wherein said container membrane
porosity allows the ingress and egress of fluidic portions of the
filler material, but retains said bone filler material.

8. The method of claim 1, further comprising molding said
container of a film.

THE REJECTIONS
The Examiner rejects various claims as unpatentable under 35 U.S.C.
§ 103(a) based on the prior art as follows (RAN 4–6):
5

1. Claim 1 over WO 99/02214 (WO/1999/002214) ("Ray") in
view of U.S. Patent No. 5,571,189 ("Kuslich ’189").
6

2. Claims 2 and 3 over Ray in view of knowledge of those skilled
in the art.
3. Claims 1–3 over U.S. Patent No. 4,969,888 ("Scholten") in
view of Kuslich ’189.
4. Claims 2 and 3 over Scholten in view of U.S. Patent No.
5,997,582 ("Weiss").
5. Claim 1 over U.S. Patent No. 6,607,544 ("Boucher") in view of
Kuslich ’189.

5
For clarity, we utilize the same numerals as the Examiner and the Patent
Owner in referring to the rejections.
6
We note that the named inventor of the reexamined ’481 patent is also the
named inventor of Kuslich ’189.
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6. Claims 2 and 3 over Boucher in view of knowledge of one
skilled in the art.
7. Claim 1 over U.S. Patent No. 6,726,691 ("Osorio") in view of
Kuslich ’189.
8. Claims 2 and 3 over Osorio in view of knowledge of one skilled
in the art.
9. Claims 4–8 over Ray in view of Kuslich ’189.
10. Claims 11, 12, 15, 16, 18, and 19 over Ray in view of
knowledge of one skilled in the art.
11. Claims 4–8 and 10–20 over Scholten in view of Kuslich ’189.
12. Claims 10–20 over Scholten in view of Weiss.
13. Claims 4–8 over Boucher in view of Kuslich ’189.
14. Claims 10, 11 and 16–18 over Boucher.
15. Claims 4–8 over Osorio in view of Kuslich ’189.
16. Claims 10–20 over Osorio.
17. Claim 9 over Ray in view of Kuslich ’189 and EP 1 083 836 B1
("Talmadge").
7

18. Claim 9 over Scholten in view of Kuslich ’189 and Talmadge.
19. Claim 9 over Boucher in view of Kuslich ’189 and Talmadge.
20. Claim 9 over Osorio in view of Kuslich ’189 and Talmadge.

7
Talmadge is an English-language publication of a European patent
resulting from International Application PCT/US/1999/012120. According
to Talmadge, International Application PCT/US/1999/012120 was published
on December 9, 1999 as WO 99/062416 (WO/1999/062416). The Patent
Owner did not appear to challenge the prior art status of Talmadge in this
proceeding.
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The Examiner also rejects various claims under 35 U.S.C. § 112 as
follows:
21. Claims 5, 8, 11, 14, 18 and 20 for lack of written description.
22. Claim 5 as being indefinite.

PRINCIPLES OF LAW
The Supreme Court warned that the "factfinder should be aware . . . of
the distortion caused by hindsight bias and must be cautious of arguments
reliant upon ex post reasoning." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,
421 (2007). In this regard,
a patent composed of several elements is not proved obvious
merely by demonstrating that each of its elements was,
independently, known in the prior art. Although common sense
directs one to look with care at a patent application that claims
as innovation the combination of two known devices according
to their established functions, it can be important to identify a
reason that would have prompted a person of ordinary skill in
the relevant field to combine the elements in the way the
claimed new invention does.
Id. at 418.
In addition, "[a] reference may be said to teach away when a person of
ordinary skill, upon reading the reference, would be discouraged from
following the path set out in the reference, or would be led in a direction
divergent from the path that was taken by the applicant." In re Gurley, 27
F.3d 551, 553 (Fed. Cir. 1994).
As to declaration evidence, "[i]t is within the discretion of the trier of
fact to give each item of evidence such weight as it feels appropriate . . . In
giving more weight to prior publications than to subsequent conclusory
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statements by experts, the Board acted well within that discretion."
Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003).

ANALYSIS
We address the various arguments of the Patent Owner infra in an
order that slightly differs from that presented by the Patent Owner and the
Requester. Only those arguments actually made have been considered and
any arguments not made are deemed to be waived. See 37 C.F.R.
§ 41.67(c)(1)(vii). We also address those arguments that are dispositive of
the appeal, independent claim 1 and claims 4–9 that ultimately depend
therefrom being addressed separately from independent claims 2, 3 and
claims 10–20 that ultimately depend therefrom.

Prior Art Rejections of Claims 1 and 4–9
As noted, the ’481 patent is directed to a method of treating the spine
using a catheter to deliver an expandable container into a vertebra, and
inflating the same with fill material (Abstract; col. 3, ll. 44–61; col. 4, ll. 32–
41; Figs. 2, 4). This method of treatment is closely related to kyphoplasty,
or balloon assisted vertebroplasty (see, generally, First Decl. Maxwell ¶¶
12–13; First Decl. Sammons ¶ 11). However, the claimed method is argued
as being different in that it requires a container having a porous outer
membrane "sufficiently porous to allow filler material under pressure to
leave the container after filling the container." The claimed method also
includes the step of injecting a filler material to "allow the bone filler
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material to exit the container," wherein the membrane allows the bone filler
material "to generate force to move the end plates of said vertebral body."
The Examiner's rejections of these claims rely on a primary reference
(Ray, Scholten, Boucher or Osorio) that discloses a spine treatment, in
combination with Kuslich ’189, which discloses an expandable, porous
fabric implant for stabilizing a spinal segment (Kuslich ’189, Title; Abs.).
The dispositive issue raised with respect to the rejections of claims 1 and 4–
9 is whether it would have been obvious to one of ordinary skill in the art, at
the time of invention, to have combined one of the primary prior art
references (Ray, Scholten, Boucher or Osorio) with Kuslich ’189 so as to
result in a method required by the claims.
According to the Patent Owner, prior to the claimed invention, it was
conventionally believed that leakage of the fill material must be avoided by
containing the same within the cavity formed inside the vertebra so as to
avoid injury to the patient (App. Br. 7-1 citing Second Decl. Maxwell ¶ 10;
see also First Decl. Sammons ¶ 14). The Patent Owner argues, inter alia,
that while each of the primary references differs slightly as to its disclosed
balloon (i.e., container) and its use, "[t]hese four references focus on
containment," which is contrary to the claimed method requiring the fill
material to "exit the container." (App. Br. 7-3; see generally id. 7-2–7-3; see
also Second Decl. Maxwell ¶¶ 11–12; First Decl. Maxwell ¶ 19). The Patent
Owner further argues that the claimed invention "defied [this] conventional
wisdom" (App. Br. 7-3), and that Kuslich ’189 does not suggest defying this
conventional wisdom (App. Br. 7-6). Thus, the Patent Owner requests the
reversal of the Examiner's rejections.
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We generally agree with the Patent Owner and do not find adequate
support in the record to conclude that a person of ordinary skill in the art, at
the time of invention, would have had a reason to combine the references as
suggested, to result in the claimed method. KSR, 550 U.S. 418. In our view
of the record, the Examiner's rejection is based in impermissible hindsight.
Id. at 421.

Art of Record
Underlying the issue of whether a person of ordinary skill in the art
would have had a reason to combine the references in the manner suggested
is the factual issue of whether, at the time of invention, it was believed in the
art that leakage of the fill material must be avoided by containing the same
within the cavity formed inside the vertebra as asserted by the Patent Owner
(App. Br. 7-1). We find that, by a preponderance of the evidence, the record
generally supports the Patent Owner's contention. Although the entire
record has been considered, we highlight some of the findings infra.
Ray
In discussing the background of its invention, Ray discusses the
concerns of leakage stating:
In order to re-inflate or re-form the collapsed vertebra and
restore the vertical height, the materials would have to be
injected within the vertebrae under considerable pressure (up to
8 or 10 atmospheres, 116 to 145 psi, 510 to 638 Newtons) so as
to overcome the collapsing force, muscle pull and tissue recoil
subjected upon the vertebra. At such high injection pressures,
the injected material may leak through the fractured or
collapsed portions of the vertebra and enter the adjacent major
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vessels, possibly causing an immediate and potentially lethal
blockage.
(Ray, pg. 6, ll. 5–12).
Ray discloses a balloon that is "manufactured to withstand high
pressures" (id. at pg. 13, ll. 8–10), and is filled with bone growth inducing
material such as "a slurry of calcium complex known to integrate into bone"
(id. at pg. 14, ll. 16–21). Ray discloses that "[t]hrough these high injection
pressures, the syringe solution inflates balloons 14, as well as[] caus[ing]
each balloon 14 to internally dissect or collapse the cancellous matrix of the
vertebral marrow within vertebral space 11 thereby creating a cavity within
the vertebral body 10." (Id. at pg. 15, ll. 9–12). Ray also discloses that the
expandable membrane can be expanded "to exert a force on the vertebral
bodies to achieve a desired spacing" (id. at pg. 8, ll. 4–8,) but this is attained
by pressurizing the expandable membrane within the vertebra cavity (see id.
at pg. 9, ll. 6–9; pg. 15, ll. 13–16; pg. 17, ll. 16–19).
Ray teaches that in one embodiment, the balloon may be permanently
left within the vertebra and may be made "from a biodegradable material so
as to permit time controlled dissolving of the balloons 14 to thereby expose
the hardening materials contained therein to the interior of vertebral space
11." (Id. at pg. 13, ll. 19–22). Ray lacks any disclosure of a porous outer
membrane, or such a membrane that allows the bone filler material to leave
or exit the container.
8

8
We address the Examiner's and the Requester's assertions to the contrary
infra.
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Scholten
Scholten discloses compaction of the cancellous bone in the vertebra
using a balloon (i.e., container), and teaches that such compaction forms a
dam wherein "the compacted bone marrow will substantially prevent flow
through the fracture." (Scholten, col. 7, ll. 17–25). After formation of the
dam, the balloon is removed, the vertebra is irrigated and then filled with a
bone substitute, but leakage "requires an abrupt stopping of the injection."
(Id. at col. 7, ll. 26–43). Scholten lacks any disclosure of a porous balloon
or such a balloon that allows the bone filler material to leave or exit the
container.
Boucher
Boucher discloses compaction of the cancellous bone in the vertebra
by expanding an expandable structure (i.e., container) with pressurized
filling material in order to move the plates of the vertebra to restore the
spacing between them (Boucher, col. 13, ll. 1–21, 46–50). Boucher also
discloses an embodiment wherein the structure is left within the vertebral
body and teaches that this significantly reduces the possibility of non-
hardened filling material leaking outside of the vertebral body (id. at col. 13,
ll. 50–55). Boucher lacks any disclosure of a porous outer membrane or
such a membrane that allows the bone filler material to leave or exit the
container.
Osorio
Osorio describes various problems associated with vertebroplasty
(Osorio, col. 2, l. 27–col. 3, l. 23), and expresses concerns over leakage
stating "[t]he most significant danger associated with vertebroplasty is the
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inability of the practitioner to control the flow of liquid bone cement during
injection into a vertebral body." (Id. at col. 2, ll. 38–41). Osorio also states
that in kyphoplasty where a cavity is formed in the vertebra using a balloon
and filled with cancellous bone, the "injected bone filler is less likely to leak
out of the vertebral body." (Id. at col. 3, ll. 27–45). In disclosing a method
of treatment, Osorio states:
In creating the cavity 170, the inflation of the catheter
201 causes the expandable material 210 to press against the
cancellous bone 115 which may form a compressed bone region
or "shell" 172 along much of the periphery of the cavity 170.
This shell 172 will desirably inhibit or prevent bone filler 180
from exiting the cavity 170, thereby inhibiting extrava[s]ation
of the bone filler and/or facilitating pressurization of the bone
filler 180, if desired, within the cavity. As the pressure in the
cavity 170 increases, the walls of the cavity 170 will desirably
be forced further outward by the bone filler 180, compressing
additional cancellous bone within the vertebral body 105 and/or
increasing the size of the cavity 170. If sufficient pressure is
available, and integrity of the shell 172 can be maintained
without significant leakage of bone filler 180, pressures capable
of moving fractured cortical bone can be developed.
(Id. at col. 9, ll. 16–32).

Osorio further states:
By creating one or more cavities within the cancellous
bone 115, the cavity-forming devices of the present invention
desirably create preferred flowpaths for the bone filler 180. In
addition, the cavity-forming devices can also desirably close
and/or block other natural flowpaths out of the cavity, such as
veins and/or cracks in the cancellous bone. … Thus, the present
invention reduces opportunities for cement leakage outside of
the vertebral body and/or improves the distribution of bone
filler throughout significant portions of the vertebral body.
(Id. at col. 17, ll. 19–29).
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Osorio discloses that in one embodiment, the balloon catheter may be
permanently left within the vertebra by refilling the deflated balloon with a
bone filler; or that the inflation medium could comprise bone filler (id. at
col. 9, ll. 4–13). Osorio also discloses that in one embodiment where the
balloon catheter is to be left within the vertebra, the balloon may be made of
"fabric/mesh material." (Id. at col. 9, ll. 13–16). Osorio further discloses
various bone filler materials (id. at col. 9, ll. 54–61), but it fails to identify
the specific bone filler material suitable for use with the embodiment
wherein the balloon is made of the disclosed fabric/mesh material. Osorio
also does not disclose that bone filler material leaves or exits the balloon
catheter.
Kuslich ’189
The Kuslich ’189 reference discloses a bag used between adjacent
vertebra to fuse them together, the bag being "[a]n expandable, porous fabric
implant for insertion into the interior of a reamed out disc which is packed
with material." (Kuslich ’189, Abs.; see also id., col. 9, ll. 46–58; col. 10, ll.
36–46). Kuslich ’189 also discloses:
The bag fabric may be woven or form-molded to a density that
will allow ingress and egress of fluids and solutions and will
allow the ingrowth and through-growth of blood vessels and
fibrous tissue and bony trabeculae, but the weave is tight
enough to retain small particles of enclosed material, such as
ground up bone graft, other tissues or solid pieces of bone
inducing material such as hydroxyapatite or other
biocompatible materials known to promote bone formation.
Generally, the pores of the fabric will have a diameter of about
0.25 mm to about 5.0 min [sic, mm]. The size is selected to
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allow tissue ingrowth while containing the material packed into
the bag.
(Kuslich ’189, col. 7, ll. 8–16).
The disclosed bag of Kuslich ’189 is used in the disc space between
two adjacent vertebra, and not within a vertebra. (See Kuslich ’189, Abs.;
col. 3, ll. 61–62; see also id., col. 1, ll. 36–39; Figs. 4–6; Second Decl.
Maxwell ¶ 16).

Declarations
The Patent Owner's Declarant Dr. Maxwell states:
11. One of the most well[-]known major risks of
vertebroplasty is bone cement leaking out of the vertebral body,
and into the surrounding anatomy, including into the patient's
vascular and neurological systems. Such leakage is very
dangerous and is associated with the most severe complications
including paralysis and remote defects, such as emboli in the
heart or brain.
. . .
14. Recognizing the risks associated with cement leakage,
the theory behind kyphoplasty is that the risk of leakage is
lessened because the bone compressed by the inflation of the
balloon creates a "wall" or barrier which contains the cement
and is intended to protect the surrounding anatomy.
(First Decl. Maxwell ¶¶ 11, 14).

The Requester's Declarant Dr. Sammons states:
11. … it was well-known in the art to have a balloon or
container injected with filler material to prevent extravasation
of such material and allow for ingrowth of such across the
fracture.
. . .
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14. … using cement directly in the cavity can be difficult to
contain and may result in unwanted leakage into the spinal
canal and cause neurological injury, including paralysis.
(First Decl. Sammons ¶¶ 11, 14).

General Arguments Regarding Claim 1
In disputing the Patent Owner's contention that it was conventional
wisdom to contain the bone filler material, the Requester argues that the
prior art references Ray, Boucher and Osorio disclose injecting of bone
growth inducing materials directly into the formed cavity, and that Ray
explicitly discloses that the contained injected material integrates into the
recipient bone (Resp. Br. 5–6 citing Second Decl. Sammons ¶ 19; Ray, pg.
14, ll. 3–6, 16–22; see also First Decl. Sammons ¶ 18).
However, the disclosure in the art of directly injecting bone growth
inducing materials into the cavity is either in the context vertebroplasty,
which is known to have significant problems with respect to leakage, or in
the context of kyphoplasty, where the bone filler material is injected into a
cavity already formed by an inflated balloon that compresses the cancellous
bone in order to significantly reduce the possibility of leakage. Such
compression of the cancellous bone supports the Patent Owner's contention
that leakage of the filler material was a significant concern in the art.
Moreover, such injection into the cavity does not speak to whether such
material exits the balloon (i.e., container) or the desirability of such exit. In
this regard, we do not view "integration" disclosed in Ray as meaning that
the bone filler material exits or leaves the balloon considering that
cancellous bone within the vertebra is living matter that grows. Thus,
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integration could occur by the cancellous bone growing into the bone filler
material without the bone filler material leaving the container as required by
the claims at issue.
The Requester, in asserting that containment is not disclosed in the art
as being necessary, argues that "there is no evidence of record that a dam [of
compressed cancellous bone] is impenetrable" and that Scholten states that
such compacted bone "will substantially prevent flow." (Resp. Br. 6 quoting
Scholten, col. 7, ll. 24–25; Second Decl. Sammons ¶¶ 11, 19). However,
even if such compressed cancellous bone is not completely impenetrable,
this does not detract from what the art understood to be desirable, or whether
a person of ordinary skill in the art would have had a reason to utilize a
method requiring a porous container wherein the bone filler material is
explicitly required to exit the container as recited in the claims. Therefore,
preponderance of the evidence of record supports the finding that at the time
of invention, it was believed that the fill material should be contained within
the cavity formed inside the vertebra in order to avoid leakage and possible
injury.
In concluding that it would have been obvious to combine one of the
primary prior art references with Kuslich ’189 to result in the method recited
in the claims, the Examiner reasons that the use of a porous container
"would not have been opposite to conventional beliefs at the time of the
invention," and the "use of any kind of containment would offer some form
of protection against leaks over and above direct filling." (RAN 51). The
Examiner also notes that Boucher discloses inflating the balloon with bone
filler material, and asserts that "[u]se of a dam would have served to reduce
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leakage and contrary to Dr. Maxwell's assertions the containers of Ray and
Osorio are not 'closed'." (Id.).
However, the question of patentability as to the rejected claims is not
limited to whether use of a porous container would have been contrary to the
conventional beliefs, but also encompasses whether a person of ordinary
skill in the art, at the time of invention, would have had a reason to combine
the references in the manner suggested to result in the claimed method
wherein the bone filler material is specifically required to exit the balloon.
The record indicates that when forming the cavity in a vertebra, a non-
leaking balloon is used to form the dam, the dam significantly reducing the
risk of leakage when the cavity is then subsequently filled with bone filler
material after removal of the deflated balloon. The fact that the prior art
discloses that the balloon may be left within the vertebra and eventually
dissolves does not alter the general containment of the filler material utilized
in the prior art.
Declarant Dr. Sammons, in support of the Requester's assertion of
obviousness, states:
An orthopedic surgeon would use a porous device rather than
directly filling a cavity with bone filler material because using
cement directly in the cavity can be difficult to contain and may
result in unwanted leakage into the spinal canal and cause
neurological injury, including paralysis. Using the porous
device maintains the ability to have bone filler incorporate into
bone to improve strength and to obtain a union of vertebral
fractures without the potential complications of filler leakage
into the spinal canal. . . . As such, [a] porous container would
reduce the risks of extravasation of cement or filler material
into high-risk regions of the spine.
(First Decl. Sammons ¶ 14).
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However, it is not evident how using a porous balloon that allows the
bone filler material to leave the balloon would "reduce the risks of
extravasation of cement or filler material into high-risk regions of the spine,"
and remove "potential complications of filler leakage into the spinal canal"
as asserted by Dr. Sammons. See Velander, 348 F.3d at 1371. Dr.
Sammons' testimony appears to be based on the assumption that a
biodegradable balloon that eventually dissolves is "porous." (See Second
Decl. Sammons ¶ 9 stating that Ray uses a porous bag). However, as
discussed infra with respect to Rejections 1 and 9, we disagree that a
membrane is "porous" because it is made of a material that eventually
dissolves, and conclude that such a construction of the term "porous" is
unreasonably broad.
The Examiner and Dr. Sammons also appear to overlook the fact that
the claims at issue not only require exit of the bone filler material from the
container, but also recite that the membrane have porosity "sufficient to
provide resistance to the flow of said bone filler material to generate force to
move the endplates of said vertebral body." If the teaching of Boucher (or
another reference of record) is used to provide a dam of compressed
cancellous bone, and this teaching is then combined with the teaching of a
porous membrane of Kuslich ’189, it is not apparent how the noted
limitation regarding moving the end plates of the vertebral body is satisfied
in the proposed combination. Although Ray, Boucher and Osorio disclose
moving the end plates, these references attain such movement by
pressurizing the balloon via the inflation material therein. While Osorio
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discloses such movement through pressurization of the filler material itself
within the cavity, it likewise expresses concern of leakage and integrity of
the shell.
The Examiner further asserts that "[t]here is no reason why a porous
balloon or bag could not be used to compact bone tissue as long as the
material leaving the bag or balloon left slow enough to allow pressure to
build up within the bag or balloon." (RAN 10). However, notwithstanding
the fact that none of the prior art references teaches or suggests such a
method, if the filler material is allowed to exit the balloon during pressure
build up, then it would appear that filler material adjacent the cancellous
bone would likewise be under pressure so that the risk associated with
extravasation noted above exists.
Furthermore, as noted above, even if a porous balloon is capable of
being used in the recited manner, that does not address the issue of whether
one of ordinary skill in the art would have had a reason to use such a balloon
in view of the extravasation concerns noted. The claims at issue are method
claims. It is inadequate to demonstrate that the structural elements of the
claim are known in the art, that the known structures are capable of being
used in accordance with the claimed method, or that portions of the claimed
method was known, such being the general approach taken by the Requester
and its declarant. Rather, the claimed method as a whole must be
demonstrated to have been obvious to a person of ordinary skill in the art at
the time the invention was made. KSR, 550 U.S. at 406.
The Requester argues that it would have been obvious to try the
porous container of Kuslich ’189 in the devices and procedures disclosed in
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the primary references (Resp. Br. 11–12). Dr. Sammons further states that it
was unwanted leakage that could cause injuries to a patient, and the benefits
of having bone filler material in contact with living bone tissue was known
in the art so that "it would have been a predictable result to one of ordinary
skill in the art to utilize a biodegradable or porous balloon so that the gold
standard of material, i.e., bone, can exit the container and contact bone."
(Second Decl. Sammons ¶ 9; see also id., ¶ 16).
While the benefits of such contact may have been known, the art of
record appears to indicate that the solution for attaining such benefit is to
utilize a slowly dissolving balloon, which makes sense considering the
recognized concern with leakage. While we have considered such benefits
as supporting the Examiner's conclusion of obviousness, we are not
persuaded that the desirability of these benefits supports the use of a
container that specifically allows exiting of the bone filler material in view
of leakage concerns and existence of an alternative that obviates such
concerns, that is, a dissolving balloon. Dr. Sammons further declares that
once other types of fillers other than cement are considered, total
containment is not necessary (Second Decl. Sammons ¶ 17). However, this
statement is not substantiated by the objective evidence of record, and does
not fully address the limitation of claim 1 that specifically recites that the
container membrane allows the bone filler material "to generate force to
move the end plates of said vertebral body" in conjunction with the filler
material exiting the container. See Velander, 348 F.3d at 1371.
The Patent Owner also argues that because Kuslich ’189 is directed to
spinal fusion procedures, it does not inform a person of ordinary skill in the
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art as to how to address concerns presented by vertebral facture procedures,
and "[t]here is no concern for containing the fill material in this type of
procedure." (App. Br. 7-6 citing Second Maxwell Decl. ¶ 34; see generally
App. Br. 7-6–7-7). We generally agree with this position of the Patent
Owner as well. The porous bag of Kuslich ’189 is not used within the
vertebra, but instead, is used outside the vertebra to fuse adjacent vertebra
together (see Kuslich ’189, Abs.). It is not evident in the record, nor is it
apparent, that concerns associated with extravasation would have been
present in such applications outside the vertebra. Thus, the Requester and
the Examiner's assertion that a person of ordinary skill in the art would look
to the bag disclosed in Kuslich ’189 for use inside the vertebra appears to be
based on hindsight.
In view of the above, it is not apparent why a person of ordinary skill
in the art would have had a reason to use a porous container that allows the
bone filler material to exit the container while also having a porosity
sufficient to "generate force to move the endplates of said vertebral body" in
accordance with claim 1 in view of the apparent concerns associated with
extravasation recognized in the art of record. KSR, 550 U.S. at 421; see also
id. at 418. Indeed, in view of the evidence of record, we do not find
adequate support in the record to conclude that a person of ordinary skill in
the art, at the time of invention, would have had a reason to combine the
references as suggested, to result in the claimed method. Rather, it appears
that a person of ordinary skill in the art at the time of invention would have
been led in a direction divergent from the path that recited in claim 1. In re
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Gurley, 27 F.3d at 553. We address the specific grounds of rejections and
address arguments relating thereto, infra.

Rejections 1 and 9
Independent claims 1 and dependent claims 4–8 depending therefrom,
stand rejected over Ray in view of knowledge of those skilled in the art, the
Examiner incorporating by reference (RAN 33, 36): Request, pages 17–20
and 36–46; Claim Chart CC-A, pages 1–8; and Requester's Comments,
pages 34–37. Thus, the position of the Examiner is that:
While Kuslich [’189] discloses that the porous fabric implant is
inserted into a disc, it would have been obvious to one of
ordinary skill in the art to use Kuslich's porous fabric bag for
insertion into the cavity of a vertebral body in light of Ray's
explicit disclosure that a similar porous balloon (e.g., balloon
14) is inserted within a collapsed vertebra 10.
[]
See Ray at
17:9–12.
It would have been obvious to one of ordinary skill in the
art to modify the balloon in Ray with the container disclosed in
Kuslich [’189]. Like Kuslich, Ray also discloses a container
for a vertebral body that allows the bone filler material to
integrate with the surrounding bone.
(Request 38–39).

However, nowhere does Ray disclose use of a "porous membrane"
that "allow[s] the bone filler material to exit the container" as required by
independent claim 1. The position of the Examiner and the Requester is that
Ray discloses a porous membrane because it discloses that "[t]he balloons
14 can be fabricated where only selected segments of the balloon's
membrane would slowly dissolve when exposed to body fluids."
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(Requester's response dated March 11, 2013 (hereinafter "Requester's
Comments"), page 38, quoting Ray, pg. 14, ll. 3–6; see also RAN 23; First
Sammons Decl. ¶ 17). Indeed, the Examiner states that Ray "discloses a
porous container after parts of it dissolve." (RAN 23).
This position of the Examiner and Requester is premised on an
unreasonably broad interpretation of the term "porous," the relevant
definitions of "porous" being "1 a: possessing or full of pores" and "2 a:
permeable to fluids." Merriam-Webster's Collegiate Dictionary, 11
th
Ed.
(2007); see also Stedman’s Medical Dictionary, 28
th
Ed. (2006) ("Having
openings that pass directly or indirectly through the substance."). The fact
that an unspecified portion of a balloon membrane dissolves does not mean
that the membrane is porous in accordance with the meaning of the term
"porous." Even assuming that Ray's balloon 14 would dissolve in such a
manner as to yield pores in accordance with the term's definition, it would
not necessarily dissolve to yield such pores to allow exiting of the bone filler
material as well as providing resistance to flow of the bone filler material to
generate force to move the end plates. Although the Requester has relied on
the First Sammons Declaration in support of its assertion, other than the
noted sentence in Ray regarding dissolving of the balloon's membrane, the
declarant does not provide any persuasive basis for the assertion that "an
orthopedic surgeon would understand that Ray's balloon is a 'porous
container.'" (First Decl. Sammons ¶ 17).
In response to the Patent Owner's argument that, in the context of Ray,
the porous membrane of Kuslich ’189 would have offered no advantage over
the dissolving balloon disclosed (App. Br. 7-12), the Examiner notes that
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"[i]t is not required that an advantage be gained by making the combination.
Ray used one type of container while the examiner maintains the container
of Kuslich [’189] would have been an obvious alternative." (RAN 14).
While we do not disagree with the Examiner that an advantage is not
required, in the present context, there would have been a recognized concern
in utilizing the porous membrane of Kuslich ’189 in the method of Ray,
namely that of risk of extravasation and potential injury discussed supra.
The Requester argues that a person of ordinary skill would have had a
reason to "use a porous container as described in Kuslich ’189 with the
procedure described in Ray to reduce the risks of extravasation of cement or
filler material into high-risk regions of the spine, but to allow ingress and
egress of bone producing cells (Resp. Br. 17, citing First Sammons Decl.
¶¶ 14, 17–18). However, as discussed above, it does not follow that using a
porous container that requires exiting of the bone filler material would
reduce the risk of extravasation, and this argument appears to be based on an
unreasonably broad interpretation of "porous" that encompasses a dissolving
membrane. Even if a person of ordinary skill in the art were aware of the
advantages of the porous membrane disclosed in Kuslich ’189 (see First
Decl. Sammons ¶ 14; Second Decl. Sammons ¶ 9), it is not apparent why a
person of ordinary skill in the art would have had a reason to combine these
references so as to use a porous container that allowed exiting of the bone
filler material and having porosity sufficient to "generate force to move the
endplates" in view of the fact that Kuslich ’189 is used outside of the
vertebra, and knowing the risks associated with extravasation.
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While the advantages of the porous membrane asserted has been
considered, in view of the above, on balance, a person of ordinary skill
would have been dissuaded from combining Ray with Kuslich ’189 to result
in the method recited in claim 1, and the Examiner's and the Requester's
contentions of obviousness appear to be based on impermissible ex post
reasoning. KSR, 550 U.S. at 421. Therefore, in view of the above, we
reverse Rejections 1 and 9 of claims 1 and 4–8.

Rejections 5 and 13
Independent claims 1 and dependent claims 4–8 depending therefrom,
also stand rejected over Boucher in view of Kuslich ’189, the Examiner
incorporating by reference (RAN 34, 42–43): Request, pages 28–30, 86–99;
Claim Chart CC-E, pages 1–16; and Requester's Comments, pages 34–37.
Thus, the position of the Examiner is that:
It would have been obvious to combine the disclosures of
Kuslich [’189] and Boucher since both references are directed
to the use of an inflatable container for vertebral repair.
Boucher discloses an expandable structure to compact
cancellous bone and create a cavity within a vertebral body so
that bone filler material may be subsequently injected into the
cavity or utilized to expand the structure (Boucher at 3:15–21,
l3:46–64) and, in a similar way, Kuslich discloses inserting an
inflatable container into a cavity between vertebrae and
injecting the container with bone filler material (Kuslich at
3:61–4:8).
In addition, both references are directed towards
restoring height within or between vertebrae.
(Request 89).

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The Examiner states that because both references "use inflatable
containers for vertebral repair to re-establish height within or between
vertebrae," it would have been obvious to try the bag of Kuslich ’189 (RAN
19). In response to the Patent Owner's argument that Boucher teaches away
from the suggested combination, and that the rejection engages in
impermissible hindsight (App. Br. 7-29), the Examiner responds that:
Boucher desires containment of the bfm [bone filler material] in
the vertebral body, not in the balloon. It is unclear how
Boucher would teach that the bfm should stay in the balloon
when the bfm ends up being injected directly into the cavity.
Boucher also teaches that the bfm can be used to inflate the bag
to perform the compaction and the balloon and bfm remains in
the cavity; or bfm expands the balloon and the balloon is
removed leaving the unhardened bfm in the cavity by itself.
(RAN 20–21).
The Requester also argues that based on the teachings of Kuslich ’189
that solutions may exit its porous container to promote bone formation, a
person of ordinary skill in the art "would use the porous container with the
method of Boucher's vertebral repair because a [person of ordinary skill in
the art] would desire the filler material to exit the bag to promote bone
formation." (Resp. Br. 29).
However, the Examiner's finding is unpersuasive because the
Examiner appears to overlook that the method of Boucher is still focused on
containment, and the fact that claim 1 not only requires the porous container
membrane to allow the bone filler material to exit, but also "provide
resistance to the flow of bone filler material to generate force to move the
end plates of said vertebral body." Boucher discloses the use of a balloon
for moving the plates of the vertebra, and does not disclose the use of a
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"porous membrane" for such purpose. Nor is it apparent why a person of
ordinary skill in the art would have had a reason to combine these references
in the manner suggested in view of the leakage concerns and the fact that
Kuslich ’189 is used outside of the vertebra as discussed supra.
Thus, for substantially the same reasons already discussed, the
Examiner and the Requester's contention of obviousness appears to be based
on impermissible ex post reasoning and we reverse Rejections 5 and 13 of
claims 1 and 4–8.

Rejections 7 and 15
Claims 1 and 4–8 stand rejected as unpatentable over Osorio in view
of Kuslich ’189, the Examiner incorporating by reference (RAN 35, 44–45):
Request, pages 34, 109–119; Claim Chart CC-G, pages 1–14; and
Requester's Comments, pages 34–37. Thus, the position of the Examiner is
that:
To the extent that the Osorio Patent does not explicitly disclose
that the container has an outer membrane sufficiently porous to
allow filler material under pressure to leave the container after
filling the container, then it may be combined with Kuslich
[’189]. Like, Osorio, Kuslich discloses a fabric bag used for
vertebral repair. . . . While, Kuslich discloses that the porous
fabric implant is inserted into a disc, it would have been
obvious to one of ordinary skill in the art to use Kuslich's
porous fabric bag for insertion into the cavity of a vertebral
body in light of Osorio's explicit disclosure that a similar fabric
bag is inserted within a collapsed vertebra 10.
(Request 111).

It is also the position of the Examiner that:
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Thus, in light of the above disclosures from Osorio and
Kuslich [’189], it would have been obvious to one of ordinary
skill in the art to use Kuslich's porous fabric bag with Osorio's
method so "it will allow ingress and egress of fluids and
solutions and will allow the ingrowth and through-growth of
blood vessels and fibrous tissue and bony trabeculae ... " in
accordance with Kuslich. This would have been obvious since
Osorio specifically discloses the use of a similar fabric bag and
similar bone filler material. Therefore, in light of the above
disclosures, the combination of Osorio in view of Kuslich
teaches a container having a porous outer membrane
sufficiently porous to allow filler material under pressure to
leave the container after filling the container.
(Request 112 (emphasis omitted); see also id. at 116 and Resp. Br.
29–30).

The Examiner also finds that the suggested combination would have
been:
an exchange of one type of porous container for another.
Osorio can use a type of bfm that limits and/or prevents
extrava[s]ation of the bfm when it is directly injected into the
cavity. Therefore, Osorio does not teach containment of the
material inside the balloon so it can't ever contact the
cancellous bone around the cavity. Osorio teaches the desire to
keep the bfm in the cavity, not in the balloon.
(RAN 21).

Osorio discloses a porous balloon catheter (i.e., container) because it
discloses that the catheter could comprise a "fabric/mesh material as the
expandable structure." (Osorio, col. 9, ll. 4–16).
9
However, it is unclear the
basis of the Examiner's assertion that "a type of bfm [bone filler material]

9
We address the Patent Owner's assertion to the contrary infra.
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that limits and/or prevents extrava[s]ation of the bfm when it is directly into
the cavity" can be used. If there is such a filler material, then it would
appear that there would be no basis for concern in the art with respect to
extrava[s]ation in vertebroplasty or kyphoplasty. Thus, it appears the
Examiner's assertion is not based on the evidence of the record.
We also reject any implicit finding of the Examiner that a porous
mesh of Osorio necessarily results in bone filler material exiting the mesh.
Exiting of the filler material is neither disclosed in Osorio, nor a necessary
outcome. In this regard, Osorio fails to disclose use of a specific bone filler
material with the embodiment wherein the balloon is made of the disclosed
mesh material. At best, Osorio's disclosed mesh would merely allow
inferring that integration of the cancellous bone may occur through the
mesh.
As to the combination of Osorio and Kuslich ’189, as already
discussed, the claims require the porous container not only allow exiting of
the bone filler material, but also allows generation of force to move the end
plates. As discussed supra, in view of the concerns expressed in the art
including Osorio as to the risk of leakage of bone filler material from the
vertebra, it is not apparent why a person of ordinary skill in the art, at the
time of invention would have had a reason to use in the method of Osorio, a
porous container from a device of Kuslich ’189, which is used outside of the
vertebra, to thereby allows the bone filler material to exit the container,
while also having a porosity sufficient to "generate force to move the
endplates of said vertebral body." Because the Examiner and the Requester's
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contentions of obviousness appear to be based on impermissible ex post
reasoning, we reverse Rejections 7 and 15 of claims 1 and 4–8.

Rejections 3 and 11
Rejections 3 and 11 reject claims 1–8 and 10–20 as obvious over
Scholten in view of Kuslich ’189. In view of their differing scope, we only
address claims 1 and 4–8 here, and address remaining claims 2, 3 and 10–20
infra. In rejecting independent claim 1, the Examiner incorporates by
reference (RAN 34, 38–40): Request, pages 22–25, 53–76; Claim Chart CC-
C, pages 1–21; and Requester's Comments, pages 35–38. Thus, the position
of the Examiner is that:
It would have been obvious to combine the disclosures of
Kuslich [’189] and Scholten since both references are directed
to the use of an inflatable container for vertebral repair.
Scholten discloses an inflatable balloon to create a cavity within
a vertebral body so that bone filler material may be
subsequently injected into the cavity (Scholten at 7:55–64) and,
in a similar way, Kuslich discloses inserting an inflatable
container into a cavity between vertebrae and injecting the
container with bone filler material (Kuslich at 3:61–4:8).
In addition, both references are directed towards
restoring height within or between vertebrae.
(Request 55; see also RAN 18–19).

The Requester argues that based on the teaching in Kuslich ’189, it
would have been obvious to utilize a porous container with fillers that
advantageously promote bone growth, and that there would be no need to
create a dam of marrow (Resp. Br. 23–24 citing Kuslich ’189, col. 7, ll. 8–
15; col. 12, ll. 10–20; First Sammons Decl. ¶ 14; Second Sammons Decl. ¶
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20). However, if a dam is not created to reduce the possibility of such
leakage, we fail to see how using a porous container does not exacerbate the
concern of leakage of bone filler material, much less address the concern.
Hence, as discussed supra, it is not apparent why a person of ordinary
skill in the art would have had a reason to combine Scholten with Kuslich
’189 in the manner suggested in view of leakage concerns, and the fact that
Kuslich ’189 is utilized outside of the vertebra. Therefore, for substantially
the same reasons discussed supra, we reverse Rejections 3 and 11 as to
claims 1 and 4–8.

Rejections 17–20
Claim 9 stands rejected as unpatentable over one of Ray, Scholten,
Bourcher or Osorio, in view of Kuslich ’189 and Talmadge. However, claim
9 depends from independent claim 1, and the Examiner's application of
Talmadge does not impact the above analysis based on one of the primary
references and Kuslich ’189. Therefore, in view of the above, we reverse
Rejections 17–20 of claim 9.

Prior Art Rejections of Claims 2, 3 and 10–20
Rejections 2 and 10
In these rejections, claims 2, 3, 11, 12, 15, 16, 18 and 19 stand
rejected over Ray in view of knowledge of those skilled in the art, the
Examiner incorporating by reference (RAN 33, 36–38): Request, pages 20–
22 and 46–52; Claim Chart CC-B, pages 1–10; and Requester's Comments,
pages 35, 37–38.
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The Patent Owner argues that "[t]he knowledge of those of skill in the
art is not a proper basis for a rejection in reexamination," and rejections must
be based upon patents and printed publications (App. Br. 7-20–7-21). The
Patent Owner notes that reliance on such knowledge is "permissible only
when the examiner has provided a declaration stating the knowledge of those
of those of ordinary skill in the art," but no such declaration has been
provided in the present case (id. at 7-21, citing 37 C.F.R. § 1.104(c)(3) and
37 C.F.R. § 1.104(d)(2)).
We are not persuaded of Examiner error. For example, as to claim 2,
the referenced "knowledge of those of skill in the art" is that:
It would have been obvious to one of ordinary skill in the art to
end injection at a point when the endplates 52 of vertebra 10
have been restored to "the normal pre-collapse vertebral height
of vertebra 10" as depicted in FIGS. 5 and 5A. This would
have further been obvious in light of Ray's disclosure that the
method was "specifically designed to re-establish or reform the
lost vertebrae height." See Ray at 7:5-9.
(Request 21–22; see also id. at 49–50).
In another example, as to claim 3, the referenced "knowledge of those
of skill in the art" is that:
To the extent that Ray does not explicitly discloses that
the lumen 34 is coupled to the balloon 14, this would have been
obvious to one of ordinary skill in the art. In particular, since
Ray discloses that (1) the lumen 34 injects materials into the
cavity and (2) the balloons may be filled with bone growth
inducing material, then it would have been obvious to one of
ordinary skill in the art that the lumen 34 would be coupled to
the balloon 14 so that material may be injected into the balloon.
(Request at 52).

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Thus, the Examiner does not rely on "knowledge of those of skill in
the art" for any specific finding of fact or knowledge that is missing in Ray,
but rather, for how such a person would understand the disclosures of Ray in
order to evaluate whether the claims would have been obvious. Ray is the
prior art patent upon which the rejection is based, and such analysis taking
into consideration the knowledge and skill of those in the art is not an error,
but instead, is a requirement for proper evaluation of patentability. KSR Int'l
Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The Patent Owner also
argues that "Ray cannot be combined with any knowledge to arrive at a
porous bag." (App. Br. 7-22). In this regard, the Patent Owner separately
argues that claims 12 and 19 are patentable over Ray because Ray does not
disclose a porous container as required by these claims (App. Br. 7-34–7-
35). While we agree with the Examiner (RAN 28) that this argument is not
pertinent to those claims that do not require a porous bag, we agree with the
Patent Owner that the Examiner erred with respect to claims 12, 15 and 19
that specifically require a porous bag. The position of the Examiner and the
Requester that Ray discloses a porous bag by disclosing that selected
segments of the balloon's membrane dissolve is not well founded based on
the definition of "porous" as discussed supra.
Therefore, in view of the above, we affirm Rejection 2 and affirm
Rejection 10 as to claims 11, 16 and 18, but reverse as to claims 12, 15 and
19.

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Rejections 8 and 16
Claims 2, 3 and 10–20 stand rejected as unpatentable over Osorio in
view of knowledge of one skilled in the art, the Examiner incorporating by
reference (RAN 35, 45–47): Request, pages 32–36 and 119–126; Claim
Chart CC-H, pages 1–12; and Requester's Comments, pages 35–38.
The Patent Owner again argues that the Examiner's reference to the
knowledge of one of ordinary skill in the art is improper (App. Br. 7-32).
However, we find this line of argument unpersuasive for reasons similar to
those already addressed relative to Rejections 2 and 10.
Referring to its arguments with respect to Rejection 5 based on
Boucher, the Patent Owner argues that Osorio is not prior art in view of a
Declaration of Steven Wolfe (id.). However, as the Patent Owner
acknowledges, Declaration of Wolfe was not entered into the record for
being untimely, and thus, is not part of the appeal (id. at 7-27; RAN 12–13,
25). The Patent Owner requests that the Board accept the declaration into
the record (App. Br. 7-27–7-28), but such action is within the purview of the
Director, the review thereof being a petitionable matter and not an
appealable one.
The Patent Owner further argues that "[t]here is no motivation to
combine Osorio with the porous balloon purportedly within the prior art."
(App. Br. 7-32, referring to arguments submitted relative to claim 1 in App.
Br. 7-31). As to claims 10–20, the Patent Owner merely refers to the
arguments addressed above in support of patentability (App. Br. 7-40).
However, we note that only claims 12 and 19, and the claims 13–15 and 20
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that depend therefrom, require a porous balloon. Thus, these arguments are
moot except as to the other claims.
As to the Patent Owner's arguments as they may pertain to the
rejection of claims 12 and 19 that require that the "container is porous," we
observe that contrary to the Patent Owner's assertion, these claims are not
rejected based on combining Osorio with other prior art to result in a porous
balloon. Rather, the rejection is based on the finding that Osorio itself
discloses a porous balloon because it discloses that "the catheter 201 which
is intended to remain with the cavity 170 could comprise a bio-absorbable
material and/or fabric/mesh material as the expandable structure." (Osorio,
col. 9, ll. 4–16; Requester's Comments 37–38). Indeed, the Examiner found
that "Osorio already discloses that the container can be made out of a bio-
absorbable fabric/mesh material. This material would be porous." (RAN
21).
The Patent Owner argues that "there is nothing inherently porous
about a fabric." (App. Br. 7-31, citing Second Decl. of Maxwell ¶ 28).
However, the relevant definition of "mesh" is "2 b: a woven, knit, or knotted
material of open texture with evenly spaced holes." Merriam-Webster's
Collegiate Dictionary, 11
th
Ed. (2007) (emphasis added); see also Celanese
Acetate LLC, Complete Textile Dictionary (2001), available at http://www
.composites.ugent.be/home_made_composites/documentation/Illustrated
_dictionary_of_fiber_and_textile_technology.pdf (defining "mesh fabrics"
as a "broad term for fabric characterized by open spaces between the
yarns"). Thus, we agree with the Examiner that "[m]esh by its very nature
and definition is porous" (RAN 22) as the term "porous" is defined as
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"possessing or full of pores." To the extent that the Patent Owner may be
arguing that Osorio does not disclose "bone filler material exiting the
container" by its reference to arguments directed to claim 1 (App. Br. 7-32),
we observe that claims 12 and 19 do not include such language. In re Self,
671 F.2d 1344, 1348 (CCPA 1982) (features not appearing in the claims
cannot be relied upon for patentability).
The Patent Owner further argues that claims 13, 14 and 20 are not
obvious over Osorio (Reb. Br. 7–16). In incorporating by reference the
Requester's Comments, the Examiner's position is that these limitations in
claims 13, 14 and 20 are obvious in view of Osorio's disclosure of an
expandable structure made of "a bio-absorbable material and/or fabric/mesh
material." (RAN 46; Requester's Comments pg. 35–36).
Claim 13 depends from claim 2 and recites that "the container
comprises knitted fabric." The Patent Owner argues that Osorio does not
disclose "knitted fabric" recited in claim 13, and that Osorio does not
necessarily disclose that its disclosed fabric/mesh is porous (Reb. Br. 8).
However, as set forth above, the very definition of "mesh" includes "knit" in
its definition. Moreover, the proper inquiry is not whether Osorio discloses
this limitation, but rather, whether such construction would have been
obvious to one of ordinary skill in the art given the disclosure of a mesh
material. We agree with the Examiner that knitting of the mesh would have
been obvious, and do not discern any patentable significance of knitting as
compared to an alternative fabrication techniques and constructions of mesh.
The Patent Owner also argues that the limitations of claims 14 and 20
requiring a liquid portion of the bone filler material to flow out of the pores
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of the container is not disclosed in Osorio, and that Osorio teaches away
from having the bone filler exit the container (Reb. Br. 13–16). Specifically,
claim 14 recites that "the porosity permits a liquid portion of the bone filler
material to flow out of the pores of the container while a particulate portion
of the bone filler material cannot flow out of the pores of the container."
Claim 14 depends from claim 12, which recites that "the container is porous"
and depends from claim 2. As reproduced above, the method of claim 2
requires the bone filler material be injected into the container under pressure
to supply a "distraction force to move said superior and inferior end plates
apart."
Thus, claim 14 is similar to independent claim 1 in that it requires a
porous container (claim 12), wherein the bone filler material is injected
under pressure to provide a force to move the end plates (claim 2), but the
bone filler material (or at least a portion thereof) also exits the container
(claim 14). Correspondingly, for substantially the same reasons discussed
supra with respect to the Examiner's rejection of claim 1, we disagree with
the Examiner's conclusion that such claimed method would have been
obvious to a person of ordinary skill in the art based on the evidence of
record.
Similar to claim 14, claim 20 recites that "the porosity permits a liquid
portion of the bone filler material to flow out of the pores of the container
while a particulate portion of the bone filler material cannot flow out of the
pores of the container." Claim 20 depends from claim 19, which recites that
"the container is porous" and depends from claim 3. We also observe that in
those embodiments of Osorio that utilize a balloon (i.e., container), filler
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material is injected into the balloon at a pressure sufficient to form the cavity
within the vertebra by compression of the cancellous bone (Osorio, col. 9, ll.
5–25). Thus, the analysis set forth supra relative to the rejection of claim 1
is also generally applicable with respect to claim 14 as it is not apparent why
a person of ordinary skill in the art would have had a reason to provide a
porous container that permits the bone filler material to exit the container in
view of the concerns associated with leakage.
Therefore, in view of the above, we affirm Rejection 8, and affirm
Rejection 16 as to claims 10–13 and 15–19, but reverse the same with
respect to claims 14 and 20.

Rejections 3 and 11
As set forth supra, we reversed the Examiner's rejection of claims 1
and 4–8 as being obvious over Scholten in view of Kuslich ’189. As to the
remaining claims 2, 3 and 10–20, the issues and arguments pertaining to
these claims are similar to those already addressed supra relative to
Rejections 2, 8, 10 and 16. Therefore, for substantially the same reasons
discussed above, we affirm the Examiner's rejection of claims 2, 3, 10–13
and 15–19. As to the rejection of claims 14 and 20 in Rejection 11, we
disagree with the Examiner that a person of ordinary skill in the art would
have had a reason to combine Scholten with Kuslich ’189 in the manner
suggested for substantially the same reasons also already discussed.
Correspondingly, we reverse Rejection 11 as to claims 14 and 20.

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Rejections 4 and 12
In these rejections, claims 2, 3 and 10–20 stand rejected as obvious
over Scholten in view of Weiss, the Examiner incorporating by reference
(RAN 34, 40–42): Request, pages 25–27 and 76–86; Claim Chart CC-D,
pages 1–13; and Requester's Comments, pages 35–38. However, as
discussed above, the Examiner's rejection of claims 2, 3, 10–13 and 15–19
has been affirmed at least with respect to one ground of rejection. Thus,
Rejection 4 of claims 2 and 3 is moot, and Rejection 12 is moot as to claims
10–13 and 15–19. As to the rejection of claims 14 and 20 in Rejection 12,
we disagree with the Examiner that a person of ordinary skill in the art
would have had a reason to combine Scholten with Weiss for reasons similar
to those also already discussed. Correspondingly, we reverse Rejection 12
as to claims 14 and 20.

Rejections 6 and 14
Rejections 6 and 14 reject claims 2, 3, 10, 11 and 16–18 as obvious
over Boucher. As set forth above, the Examiner's rejection of these claims
has been affirmed with respect to at least one ground of rejection. Thus,
these rejections are moot, and we decline to reach the same.
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Rejections Under 35 U.S.C. § 112
Rejection 22
Claim 5 stands rejected as indefinite, the Examiner concluding that
claim 5 contradicts claim 1 from which it depends (RAN 50). Specifically,
the Examiner states that because claim 5 recites that the container membrane
retains bone filler material, this limitation contradicts the limitation in claim
1 reciting that "the bone filler material [] exit[s] the container." (Id.). The
Patent Owner argues that there is no contradiction because claim 5 "provides
more detail" to claim 1 that recites filler material leaving the container in
that "the portion of the filler material that leaves is the fluidic portion."
(App. Br. 7-43).
The Patent Owner's argument does not fully address the rejection and
we are not persuaded that the Examiner erred. The problem with the Patent
Owner's argument is that claim 1 clearly recites that it is "the bone filler
material" that exits the container. In contrast, claim 5 recites that the very
same "said bone filler material" is retained. Claim 1 does not say a portion
of the bone filler material exits the container. Nor does claim 5 state that a
certain portion of the bone filler material is retained. Rather, these claims
refer to the same "bone filler material." Thus, it is unclear whether the
porous outer membrane permits the bone filler material to exit the container
(as recited in claim 1), or whether the membrane retains the filler material
(as recited in claim 5). Therefore, we affirm Rejection 22.
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Rejection 21
Claims 5, 8, 11, 14, 18 and 20 stand rejected for lack written
description. However, as discussed above, claims 11 and 18 remain rejected
as unpatentable over the prior art, while claim 5 remains rejected as being
indefinite. Thus, this rejection is moot with respect to claims 5, 11 and 18.
As to claim 8, the Examiner concludes that while the Specification of
the ’481 patent seems to provide support for molding the container, and
wherein the container is a film, "the specification fails to provide support for
molding the container of a film." (RAN 49). The Patent Owner argues that
the Examiner's position is contradictory (App. Br. 7-2). We disagree with
the Patent Owner and find no contradiction in the Examiner's position.
The Specification of the ’481 patent states that "[t]he bag 22 need not
be woven and may be molded or otherwise formed as is well known in the
art." (Col. 5, ll. 34–35). Thus, it is apparent that "molded" refers to a
manner in which the bag is made. The Specification of the ’481 patent also
states that "[t]he bag 22 may be partially or totally absorbable, metal, plastic,
woven, solid film or an extruded balloon." (Col. 5, ll. 34–35). However,
these disclosures do not disclose "molding" a container of "film." It is also
not evident from the Specification of the ’481 patent that a "container of a
film" construction can be "molded" considering other various disclosed
methods of making the container, or that molding necessarily results in a
film construction.
Thus, it is not evident that a person of ordinary skill would reasonably
understand the above noted disclosures in the Specification of the ’481
patent as demonstrating that the inventor had possession of the invention
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now claimed. The "test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date."
Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed.
Cir. 2010). "[A] description that merely renders the invention obvious does
not satisfy the requirement." Id. Correspondingly, we affirm Rejection 21
as to claim 8.
As to claims 14 and 20, the Examiner incorporates the rejection as
proposed on page 34 of the Requester's Comments, which states
Requester submits that there is no support . . . for the phrase
"permits a liquid portion of the bone filler material to flow out
of the pores of the container while a particulate portion of the
bone filler material cannot flow out..." (claims 14 and 20). The
portions cited by the Patent Owner at column 3, lines 34–41,
fail to provide adequate support for these claims.
(Requester's Comments 34).
The Patent Owner argues that these claims are "supported by Kuslich
’481 at 4:34–41." We agree with the Patent Owner. The Specification of
the ’481 patent discloses:
Fabric 23 may be woven, knitted, braided or form-molded to a
density that will allow ingress and egress of fluids and solutions
and will allow the ingrowth and through-growth of blood
vessels and fibrous tissue and bony trabeculae, but the fabric
porosity is tight enough to retain small particles of enclosed
material, such as ground up bone graft, or bone graft substitute
such as hydroxyapatite or other osteoconductive biocompatible
materials known to promote bone formation.
(Col. 4, ll. 33–41, emphasis added).
While the Specification of the ’481 patent does not utilize the precise
language recited in claims 14 and 20, adequate support is provided to
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demonstrate possession. Use of the exact terms is not a requirement for
written descriptive support. Ariad Pharmaceuticals, Inc. v. Eli Lilly and
Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (the specification need not recite
the claimed invention in haec verba).
Therefore, in view of the above, we affirm the Examiner's written
description rejection with respect to claim 8, but reverse the same with
respect to claims 14 and 20. As noted, this rejection as to claims 5, 11 and
18 is moot and we decline to reach the same.

ORDERS
1. Rejection 1 is reversed.
2. Rejection 2 is affirmed.
3. Rejection 3 is:
a. Reversed with respect to claim 1; and
b. Affirmed with respect to claims 2 and 3.
4. Rejection 4 is moot.
5. Rejection 5 is reversed.
6. Rejection 6 is moot.
7. Rejection 7 is reversed.
8. Rejection 8 is affirmed.
9. Rejection 9 is reversed.
10. Rejection 10 is:
a. Reversed with respect to claims 12, 15 and 19; and
b. Affirmed with respect to claims 11, 16 and 18.
11. Rejection 11 is:
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a. Reversed with respect to claims 4–8, 14 and 20; and
b. Affirmed with respect to claims 10–13 and 15–19.
12. Rejection 12 is:
a. Reversed with respect to claims 14 and 20; and
b. Moot with respect to claims 10–13 and 15–19.
13. Rejection 13 is reversed.
14. Rejection 14 is moot.
15. Rejection 15 is reversed.
16. Rejection 16 is:
a. Reversed with respect to claims 14 and 20; and
b. Affirmed with respect to claims 10–13 and 15–19.
17. Rejection 17 is reversed.
18. Rejection 18 is reversed.
19. Rejection 19 is reversed.
20. Rejection 20 is reversed.
21. Rejection 21 is:
a. Reversed with respect to claims 14 and 20;
b. Affirmed with respect to claim 8; and
c. Moot with respect to claims 5, 11 and 18.
22. Rejection 22 is affirmed.

SUMMARY
The Examiner's rejection of claims 2, 3, 5, 8, 10–13 and 15–19 is
affirmed. The Examiner's rejection of claims 1, 4, 6–9, 14 and 20 is
reversed.
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Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. § 1.956. In the event neither party
files a request for rehearing within the time provided in 37 C.F.R. § 41.79,
and this decision becomes final and appealable under 37 C.F.R. § 41.81, a
party seeking judicial review must timely serve notice on the Director of the
United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and
1.983.

AFFIRMED-IN-PART

Third Party Requester:

NDQ SPECIAL REEXAM GROUP
1000 LOUISIANA STREET
53RD FLOOR
HOUSTON, TX 77002

Patent Owner:

Carlson, Caspers, Vandenburgh, Lindquist &
Schuman, PA
225 South 6th Street
Suite 4200
Minneapolis, MN 55402