Ex Parte Kuras

Board of Patent Appeals and Interferences

Sep 24, 2008

10457589 (B.P.A.I. Sep. 24, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JAMES MICHAEL KURAS
__________

Appeal 2008-0151
Application 10/457,589
Technology Center 3700
__________

Decided: September 24, 2008
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS and ERIC GRIMES,
Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness and obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b).

Appeal 2008-0151
Application 10/457,589

The following claims are representative.
1. An artificial disc to replace a damaged spinal disc in a spinal
column, said artificial disc comprising:
a resilient core having an upper surface and a lower surface;
an upper retaining member having an outer surface engageable with a
first vertebra of the spinal column and an inner surface immovably affixed to
said upper surface of said resilient core; and
a lower retaining member having an outer surface engageable with a
second vertebra of the spinal column and an inner surface immovably
affixed to said lower surface of said resilient core;
one of said upper and lower retaining members having an opening
extending through said outer and inner surfaces of said one of said upper and
lower retaining members, said opening being located between the first and
second vertebrae when said outer surfaces of said upper and lower retaining
members engage the first and second vertebrae.

9. An artificial disc as defined in claim 1 wherein said resilient core
deflects toward said opening extending through said outer and inner surfaces
of said one of said upper and lower retaining members upon relative
movement between said upper and lower retaining members.

14. An artificial disc to replace a damaged spinal disc in a spinal
column, said artificial disc comprising:
a resilient core having an upper surface and a lower surface;
an upper retaining member having an outer surface engageable with a
first vertebra of the spinal column and an inner surface immovably affixed to
said upper surface of said resilient core; and
a lower retaining member having an outer surface engageable with a
second vertebra of the spinal column and an inner surface immovably
affixed to said lower surface of said resilient core;
one of said upper and lower retaining members having an opening
extending through said inner surface of said one of said upper and lower
retaining members into which said resilient core deflects upon relative
movement between said upper and lower retaining members.

15. An artificial disc as defined in claim 14 wherein said upper
retaining member has an opening extending through said inner surface of
said upper retaining member into which said resilient core deflects upon
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relative movement between said upper and lower retaining members, said
lower retaining member having an opening extending through said inner
surface of said lower retaining member into which said resilient core deflects
upon relative movement between said upper and lower retaining members.

Cited References
Serhan US 5,824,094 Oct. 20, 1998
Weber US 6,533,818 B1 Mar. 18, 2003
Kuras US 7,169,181 Jan. 30, 2007

Bray WO 97/20526 Jun. 12, 1997

Grounds of Rejection
1. Claims 1-6, 8-19 and 21-22 stand rejected under 35 U.S.C. 103(a)
as being unpatentable over Weber in view of Bray.
2. Claims 1-3, 7, 13-16, 20 and 22 stand provisionally rejected under
the judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 15, 17 and 18 of copending Application No.
10/315,373 (now U.S. Patent No. 7,169,181 issued Jan. 30, 2007) in view of
Serhan.

DISCUSSION
Background
The present invention relates to “[a]n artificial disc to replace a
damaged spinal disc in a spinal column.” (Spec. 2.)

1. Claims 1-6, 8-19 and 21-22 stand rejected under 35 U.S.C. 103(a)
as being unpatentable over Weber in view of Bray. We select claim 1 as
representative of claims not individually argued in the rejection before us,

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however we address individually argued claims separately. 37 C.F.R. §
41.37(c)(1)(vii).
The Examiner finds that:
Weber et al. disclose an artificial disc 10 with a porous
top or "an upper retaining member" 12, a porous bottom or "a
lower retaining member 14," and a central layer or "resilient
core" 16 strongly bonded or "immovably affixed" to the upper
and lower members (col. 4, lines 57-67 and col. 5, lines 1-31).

(Ans. 4.)
“Weber et al. disclose all elements of the claimed invention except for
the pores or holes in each of the upper and/or lower retaining members
extending through the entire thickness of each of the upper and/or lower
retaining members.” (Ans. 4.)
The Examiner relies on Bray as teaching “a prosthesis with porous
upper and lower members wherein each member is made porous by a
plurality of pores wherein the pores are holes 40 extending through the
entire thickness of each of the upper and lower members (Figs. 6-7 and 15,
page 6, lines 36-38 and page 7, lines 3-6).” (Ans. 4.)
The Examiner concludes that “[i]t would have been obvious to one of
ordinary skill in the art at the time the invention was made to have made the
upper and lower retaining members of the Weber et al. prosthesis porous by
drilling through holes, as taught by Bray, to allow for bone growth.” (Ans.
4.)
Appellant puts forth the Declaration of Kuras as evidence of non-
obviousness. Appellant further contends that Bray cannot be considered
analogous art because it does not disclose an artificial disc implant, but is a

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fusion device for use in preventing movement between adjacent vertebrae.
(App. Br. 6-7; Kuras Declaration ¶ 13.)
Appellant argues that bone does not grow through the layers 12 and
14 of Weber to fuse the adjacent vertebrae together as in Bray. (App. Br. 7.)
Appellant further argues that “in contrast to the present invention, Weber
does not teach an opening in one of the layers to reduce the stress at the
interface with the central layer.” (Br. 7.)
We are not persuaded by Appellant’s argument. First, claim 1 does
not recite “an opening in one of the layers to reduce the stress at the interface
with the central layer,” as alleged by Appellant. Claim 1 requires an
opening extending through the outer and inner surfaces of one of the upper
and lower retaining members.
Weber, Fig. 2, shows that a top layer 12 and bottom layer 14 are made
of a bone permeable material, preferably porous titanium. (Weber, col. 4, ll.
7-10 and 63-66; col. 5, ll. 3.) While we acknowledge the device of Weber
does not fuse vertebrae like Bray’s device, it does, according to Appellant,
permanently interconnect the vertebrae (App. Br. 7; Kuras Declaration ¶ 10)
and includes pores through which bone can grow to hold the artificial disc in
place.
Bray is relied on by the Examiner solely for its disclosure to one of
ordinary skill in the art of an alternative or substitute structure for the pores
of Weber, wherein the substitute structure includes holes through which
bone can grow and which is also useful for holding an implant structure in
place. “[W]hen a patent claims a structure already known in the prior art
that is altered by the mere substitution of one element for another known in

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the field, the combination must do more than yield a predictable result”.
KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1740 (2007). Alternatively,

If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same
reason, if a technique has been used to improve one device,
and a person of ordinary skill would recognize that it would
improve similar devices in the same way, using the technique
is obvious unless its actual application is beyond his or her
skill.

Id. Thus we are not persuaded that Bray is non-analogous art to Weber and
the claimed disc implant, as it similarly provides holes for bone growth for
holding an implant structure in place.
Appellant argues that Weber and Bray do not solve the same problem
solved by Appellant. (Br. 7; Declaration Kuras ¶ 8, 9, 13.) However, “[i]n
determining whether the subject matter of a patent claim is obvious, neither
the particular motivation nor the avowed purpose of the patentee controls.
. . . 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, 127 S.Ct. at 1741-42.
The Examiner points to a problem in the art, how to stabilize an
implant structure via bone ingrowth, and provides an alternative method to
the porous titanium of Weber known in the art for solving this problem, i.e.,
holes in the structure’s top and bottom through which bone can grow as in
Bray. Thus, the Examiner has provided a reason why those of ordinary skill
in the art would have combined the elements in the manner claimed.
For the reasons articulated herein, we do not find the Declaration of
Kuras to be convincing evidence of non-obviousness.
The rejection of claims 1-6, 8, 11, and 13 is affirmed.

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Claims 9-10, 12 and 14-22
Appellant presents separate arguments for individual claims 9-12 (Br.
14-15), and for claims 14-21, argued as a group. (Br. 16.) Appellant also
argues claim 22 separately. (App. Br. 21-22.) While we agree with the
Examiner (Ans. 9-10) that the device suggested by Weber and Bray meets
the limitations of claim 11, we conclude that claims 9, 10, 12 and 14-22
stand on a different footing than claim 1.
Regarding claims 9-10, 12 and 14-22, the Examiner finds that Weber
"disclose[s] that resilient core 16 is made of a soft compressible material that
matches the mechanical properties of the nucleus in natural discs (col. 5,
lines 10-21)." (Ans. 4.) It is the Examiner's position that deflection of the
core toward the opening(s) in the upper and lower retaining members in the
implant of the combination of Weber and Bray would be an inherent
property of the soft, elastic and compressible core. (Ans. 4.)
Appellant argues that the Examiner “does not specifically set forth
how the cited prior art describes or suggests a resilient core deflecting
toward an opening” in the upper or lower retaining member (App. Br. 14).
Appellant also argues that in the combination of Weber and Bray, "the core
cannot deflect into the openings since the openings are already filled" with
bone. (Reply Br. 3.)
"[O]bviousness requires a suggestion of all limitations in a claim."
CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)). We agree with
Appellant and find that the Examiner has not provided sufficient evidence in
the prior art of the limitation “said resilient core deflects toward said

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opening extending through said outer and inner surfaces of said one of said
upper and lower retaining members upon relative movement between said
upper and lower retaining members,” as claimed.
The instant Specification states that the resilient core “is made of a
urethane silicone blend” (Spec. 6). Weber, by contrast, discloses that the
central layer of its device is made of a polymer like “polyurethane,
polydimethyl siloxane, polyvinyl chloride (PVC), polyethylene and teflon”
(Weber, col. 5, ll. 14-15). The Examiner has not provided adequate
evidence to show that the polymers taught by Weber would inherently
deflect in the same manner as the urethane silicone blend disclosed in the
instant Specification. In addition, we do not find a suggestion in the cited
prior art that deflection of the core toward the opening(s) in the upper and
lower retaining members is possible when the openings are filled with bone.
Thus, the rejection of claims 9-10, 12 and 14-22 is reversed.

2. Claims 1-3, 7, 13-16, 20 and 22 stand provisionally rejected under
the judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 15, 17 and 18 of copending Application No.
10/315,373 (now U.S. Patent No. 7,169,181 issued Jan. 30, 2007) in view of
Serhan. We select claim 1 as representative of the rejection before us since
Appellant has not separately argued the claims. 37 C.F.R. 41.37(c)(1)(vii).
The Examiner finds that
Claims 15, 17 and 18 of CPA '373 disclose all elements
of the claimed invention except for: (1) the resilient core being
immovably affixed to the upper and lower retaining members;
and (2) deflection of the core toward or into the opening
extending through the outer and inner surfaces of one of the

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upper and/or lower retaining members upon relative movement
between the upper and lower retaining members.

(Ans. 6.) We note, however, that claim 15 as allowed in U.S. Patent
No. 7,169,181, does include a limitation that the resilient core is
immovably affixed to the upper and lower retaining members. Thus it
would appear that the second limitation, the deflection of the core
toward or into the opening is the only limitation in the pending claims
not recited in the patented 15, although it does appear in patented
claims 24 and 25.
Regarding the limitation in claims 14 and 15 of the pending
application of "deflection of the core toward or into the opening extending
through the outer and inner surfaces of one of the upper and/or lower
retaining members upon relative movement between the upper and lower
retaining members," it is the Examiner's position that this is an inherent
property of the resilient or elastic core of claim 1 of U.S. Patent No.
7,169,181. (Ans. 6.)
Appellant contends that none of the claims of the present application
recite a resilient core having a surface extending from one of upper and
lower surfaces of the core toward another of the upper and lower surfaces
and at least partially defining an empty space extending from the one of the
upper and lower surfaces. (Reply Br. 5.) Appellant further argues that
claims 15, 17 and 18 depend from claim 1 of U.S. Patent No. 7,169,181 and
include all the limitations of claim 1. (Reply Br. 10.)
To determine if obviousness-type double-patenting is present
one must determine if any claim in the application at issue defines

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merely an obvious variation of an invention disclosed and claimed in
the cited patent. In re Vogel, 422 F.2d 438, 441-42 (CCPA 1970).
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.” In
re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Thus, in obviousness-type
double patenting rejections, the Examiner must establish, in an analysis
comparable to that under 35 U.S.C. § 103, that one of ordinary skill would
have considered the rejected claims obvious over the conflicting claims. See
In re Braat, 937 F.2d 589, 592-93 (Fed. Cir. 1991).
To show that a claimed invention is "a mere variation . . . which
would have been obvious to those of ordinary skill in the relevant art . . .
there must be some clear evidence to establish why the variation would have
been obvious..." In re Kaplan, 789 F.2d 1574, 1580 (Fed. Cir. 1986).
The disclosure of a reference patent may not be used as prior art; in certain
situations, however, it may be used to define terms in claims and to
determine whether an embodiment claimed was modified in an obvious
manner. Carman Indus., Inc. v. Wahl, 724 F.2d 932, 940 (Fed. Cir. 1983).
In the present case claims 15-17 of U.S. Patent No. 7,169,181 read as
follows:
15. An artificial disc [to replace a damaged spinal disc in a spinal
column, said artificial disc comprising:
an upper retaining member having an outer surface engageable with a
first vertebra of the spinal column and an inner surface;
a lower retaining member having an outer surface engageable with a
second vertebra of the spinal column and an inner surface; and
a resilient core interconnecting said upper and lower retaining
members, said resilient core having an upper surface immovably affixed to
said inner surface of said upper retaining member, said resilient core having
a lower surface immovably affixed to said inner surface of said lower

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retaining member, said resilient core having a surface extending from one of
said upper and lower surface toward another of said upper and lower
surfaces and at least partially defining an empty space extending from said
one of said upper and lower surfaces]1
wherein one of said upper and lower retaining members has an
opening extending through said inner and outer surfaces of said one of said
upper and lower retaining members.

16. An artificial disc as defined in claim 15 wherein said opening
extending through said inner and outer surfaces of said one of said upper and
lower retaining members is aligned with said empty space.

17. An artificial disc as defined in claim 1 wherein said upper
retaining member has an opening extending through said inner and outer
surfaces of said upper retaining member, said lower retaining member
having an opening through said inner and outer surfaces of said lower
retaining member.

The disc structure of claim 1 of the present application reads on the
structure of claim 15 of U.S. Patent No. 7,169,181. While claim 1 of the
pending application does not recite a resilient core having a surface
extending from one of upper and lower surfaces of the core toward another
of the upper and lower surfaces and at least partially defining an empty
space extending from the one of the upper and lower surfaces, it does define
a disc structure wherein one of the upper and lower retaining members has
an opening extending through the outer and inner surfaces of the upper or
lower retaining member. When this opening of pending claim 1 is read in
conjunction with the resilient core, the resulting inherent structure defines "a
resilient core having a surface extending from one of upper and lower
surfaces of the core toward another of the upper and lower surfaces and at

1 Bracketed material is reproduced from patent claim 1 from which claim 15
depends.

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least partially defining an empty space extending from the one of the upper
and lower surfaces."
We also agree with the Examiner that the limitation of the instant
claims that the core deflect toward or into the opening does not patentably
distinguish them from the claims of the ‘181 patent. Both the instant
Specification and the ‘181 patent state that the resilient core is made of a
urethane silicone blend (Spec. 6; ‘181 patent, col. 3, l. 13). Thus, the core of
the patented device and of the instantly claimed device would inherently
have the same properties.
In view of the above, we find that that one of ordinary skill would
have considered the rejected claims obvious over the disc of the conflicting
claims, and the obviousness-type double patenting rejection of claim 1 is
affirmed. Claims 2-3, 7, 13-16, 20 and 22 fall with claim 1.

SUMMARY
The obviousness rejection of claims 1-6, 8, 11, 13 is affirmed. The
obviousness rejection of claims 9, 10, 12 and 14-22 is reversed. The
obviousness-type double patenting rejection is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART
Ssc:

TAROLLI, SUNDHEIM, COVELL & TUMMINO L.L.P.
1300 EAST NINTH STREET, SUITE 1700
CLEVELAND, OH 44114

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