Ex Parte Ferree

Board of Patent Appeals and Interferences

Jul 10, 2008

10412917 (B.P.A.I. Jul. 10, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte BRET A. FERREE
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Appeal 2007-40601
Application 10/412,917
Technology Center 3700
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Decided: July 10, 2008
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Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and JEFFREY
N. FREDMAN, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the final rejection of claims 2-15.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.2

1 Oral Hearing held June 17, 2008.
2 In this decision we consider only those arguments actually made by
Appellant. Arguments that Appellant could have made but chose not to
make in the Briefs have not been considered and are deemed to be waived.
See 37 C.F.R. § 41.37(c)(1)(vii).
Appeal 2007-4060
Application 10/412,917

STATEMENT OF THE CASE
The claims are directed to an artificial disc replacement device to treat
vertebral disc degeneration. Claims 2-15 are pending and appealed. The
following rejections are on review:
1) Claims 2 and 15 under 35 U.S.C. § 102(b) as anticipated by Patil
(U.S. Pat. No. 4,309,777, issued Jan. 12, 1982) (Ans. 3);
2) claims 2-7, 9, 10, and 14 under 35 U.S.C. § 102(e) as anticipated by
Zdeblick (U.S. Pat. No. 6,402,785 B1, issued Jun. 11, 2002) (Ans. 3);
3) claim 8 under 35 U.S.C. § 103(a) as obvious over Patil (Ans. 4);
4) claims 11-13 under 35 U.S.C. § 103(a) as obvious over Zdeblick
(Ans. 4); and
5) claim 7 under the judicially-created doctrine of obvious-type
double patenting as unpatentable over claim 3 of copending Application No.
10/303,385 (now U.S. Pat. No. 7,201,776, issued Apr. 10, 2007) in view of
Zdeblick (Ans. 3).
The following claims3 are representative of the rejected claims:
2. An artificial disc replacement (ADR), comprising:
an upper endplate component adapted for fixation to an upper
vertebral body, the upper endplate component including an inferior surface
facing an intervertebral disc space;
a lower endplate component adapted for fixation [to] a lower vertebral
body, the lower endplate component including a superior surface facing the
intervertebral disc space; and
a shape-memory spacer component having upper and lower surfaces,
and wherein the spacer includes:

3 The claims are reproduced from Appendix A of the Appeal Brief.
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a first state wherein the spacer is flattened or otherwise
compacted to facilitate insertion into the intervertebral disc space
between the endplate components, and
a second state wherein the spacer is expanded such that its
upper and lower surfaces are in conformal contact with the inferior
and superior surfaces of the respective endplate components.

6. The ADR of claim 2, wherein:
one of the inferior and superior surfaces of the respective endplate
components is substantially flat; and the corresponding surface of the spacer
is also flat.

7. The ADR of claim 2, wherein the spacer component is not attached to
either one of the endplate components.

8. The ADR of claim 2, wherein the spacer component is composed of
Nitinol.

9. The ADR of claim 2, wherein the spacer component is composed of a
polymer.

10. The ADR of claim 2, wherein the spacer component is composed of a
hydrogel.

11. The ADR of claim 2, wherein the spacer component is composed of a
methacrylate.

12. The ADR of claim 2, wherein the spaced is composed of stearic
methacrylate.

13. The ADR of claim 2, wherein the spacer component expands due to a
change in temperature.

CLAIM INTERPRETATION
Claim 2 is directed to an artificial disc replacement (ADR) that
comprises three elements: 1) an upper endplate component, 2) a lower
endplate component, and 3) a shape memory spacer component. The upper
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and lower endplates are “adapted for fixation” to the upper and lower
vertebral bodies, respectively.
The spacer component “includes: a first state wherein the spacer is
flattened or otherwise compacted to facilitate insertion into the intervertebral
disc space” and “a second state wherein the spacer is expanded such that its
upper and lower surfaces are in conformal contact” with the endplate
components. We interpret the two “state” requirement to be an intended use
of the claimed ADR. Thus, when the spacer is inserted into the disc space, it
is in a “flattened” or “compacted” state. After insertion, it is “expanded”
into the space to contact the endplate components – which is the “expanded”
state. Claim 2, however, does not require the spacer to be in either the
flattened or expanded state – only that it has a structure which enables the
two states to be achieved when used in the process of vertebral disc
replacement.
1. ANTICIPATION BY PATIL
Claims 2 and 15 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Patil.
Findings of Fact
The Patil patent
1. Patil teaches an artificial intervertebral disc for implantation into a disc
space (Patil, Abstract).
2. The artificial disc has upper and lower disc portions 12 and 14,
respectively (Patil, at col. 1, ll. 62-65; see Fig. 2).
3. “A plurality of compression springs 16 are positioned between the disc
portions 12 and 14 . . . to yieldably urge the disc portions 12 and 14 away
from each other” (Patil, at col. 2, ll. 3-6; see Figs. 2 and 4)
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4. “During implantation, the upper and lower lid portions 12 and 14 are
maintained closely together by securing one or two wires therearound. After
implantation, the wires will be cut and pulled from the space thereby
allowing the lid portions 12 and 14 to move in opposite directions to exert an
outward pressure and to cause the spikes 18 and 22 to engage the vertebrae
20 and 24” (Patil, at col. 2, ll. 25-33; see Figs. 2 and 4).
Application of the prior art to the claimed invention
5. Patil’s artificial intervertebral disc comprises upper and lower disc
portions 12 and 14 (FF 1, 2) which satisfy the limitations of claim 2 of 1)
“an upper endplate component” and 2) “a lower endplate component.”
6. The “compression springs 16” (FF 3) serve as spacers between the
endplates as does the 3) shape memory spacer component of claim 2.
7. The “compression springs 16” (FF 3) are in a “flattened” state when
secured by wires (FF 4) and in an “expanded” state when the wires are cut
after implantation (FF 4). Thus, the compression springs have two states
when used in the process of disc replacement. These two states meet the
requirement of claim 2 of “a first state where the spacer is flattened” and “a
second state wherein the spacer is expanded” and in contact with the
endplate surfaces (see Ans. 3 stating that Patil’s “spacer expands due to
mechanical relaxation”; Ans. 5).
8. In sum, Patil describes an artificial intervertebral disc replacement which
comprises all three elements required by claim 2 (FF 5-7).
Analysis
To anticipate, every element and limitation of the claimed invention
must be found in a single prior art reference, arranged as in the claim.
Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir.
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2001). In this case, we agree with the Examiner’s findings as summarized
above (see FF 1-8; Ans. 3, 5) that the artificial intervertebral disc described
by Patil comprises every limitation of the claimed invention, anticipating it.
Thus, we turn to Appellant’s arguments.
Appellant contends that claim 2 requires “that the end plate
components are already in place in the intervertebral disk space, when the
spacer is compacted and inserted” between them (App. Br. 3). He argues
that Patil does not describe insertion of a flattened spacer into a disc space
having endplates already in place (id.)
This argument is not persuasive. Claim 2 is directed to a medical
device – not a process of inserting the device into a disc space. Appellant’s
argument about how the spacer is inserted between endplates already fixed
to the vertebral bodies might be relevant to the extent that a process is
claimed, which is not the case here. Appellant contends that “anyone of skill
in the art” would recognize that the end plate components are “already in
place” (App. Br. 3) but fails to identify the specific language in claim 2 that
would lead to this interpretation. To the contrary, the claim only requires
that the device has endplates and a spacer having two states – elements
which are met by Patil. Other than distinguishing Patil by how the claimed
device is used, Appellant does not describe any structural differences
between claimed invention and the prior art artificial disc.
We affirm the rejection of claim 2. Claim 15 falls with claim 2
because separate reasons for its patentability were not provided. See 37
C.F.R. § 41.37(c)(1)(vii).

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2. ANTICIPATION BY ZDEBLICK
Claims 2-7, 9, 10, and 14 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Zdeblick.
Findings of Fact
9. Zdeblick describes an “artificial disc implant for replacing the spinal disc
between two vertebrae of the spine. The implant comprises an upper shell, a
lower shell and a spacer or insert therebetween” (Zdeblick, at col. 1, ll. 41-
44).
10. The spacer can be formed from hydrogel where the hydrogel is “slightly
dehydrated thereby reducing the height of the implant for insertion. Once
inserted, the hydrogel can be hydrated to increase of the overall height of the
implant to the desired working height” (Zdeblick, at col. 2, ll. 39-45; see
Ans. 3-4 and 6).
11. “The three components of top shell 12, spacer 16, and lower shell 14 are
preferably inserted into an intervertebral disc space as a single unit. The
upper and lower shells may be urged towards one another to compress
spacer 16. In a compressed condition, the entire implant may be loaded into
a delivery tube or sleeve which will maintain at least a portion of the
compression during insertion. . . .
. . . Once positioned in the disc space, the hydrogel may be rehydrated
to thereby fully expand spacer 16 and restore implant 10 to the desired
height in the disc space” (Zdeblick, at col. 6, 25-65; see Fig. 3).
12. Figs. 38 and 39 show an implant (350, 360) having rectangular or square
upper and lower shells (352, 354; 362, 364) and a substantially square spacer
(356, 366) between them (Zdeblick, at col. 11, ll. 31-46; see Ans. 6-7).
Application of the prior art to the claimed invention
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13. Zdeblick describes a disc implant having an upper shell, a lower shell
and a spacer (FF 9, 11) – the same three elements required for the ADR of
claim 2.
14. The spacer described in Zdeblick can be a hydrogel which is in a
flattened state prior to insertion and an expanded state after insertion (FF 10,
11), meeting the two state requirement of claim 2 (see “Claim
Interpretation” supra.).
15. The disc implant of Zdeblick can have rectangular or square end plates
and spacers (FF 12) and thus would have flat surfaces as recited in claim 6.
16. Claim 9 is directed to the ADR of claim 2, “wherein the spacer
component is composed of a polymer.”
17. A hydrogel is a polymer and thus meets all the limitations of claim 9
(Ans. 8).
Analysis
To anticipate, every element and limitation of the claimed invention
must be found in a single prior art reference, arranged as in the claim.
Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d at 1383. In this case,
we agree with the Examiner’s findings as summarized above (see FF 9-14)
that the artificial disc described by Zdeblick comprises every limitation of
claim 2, anticipating it. Thus, we turn to Appellant’s arguments.
Appellant argues, as he did for the rejection over Patil, that Zdeblick
does not “fairly teach or suggest a spacer which is compacted for insertion
between end plates and positions within an intervertebral disk space” (App.
Br. 3).
This argument does not convince us that the Examiner erred. As we
discussed previously under the rejection over Patil, claim 2 does not require
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the claimed endplates to be in position on the vertebral bodies when the
spacer is inserted between them. Rather, the elements of claim 2 can be in
any configuration or arrangement as long as all three elements (two
endplates and a spacer) are present. Zdeblick describes all three elements;
Appellant has not otherwise distinguished the claimed structure from
Zdeblick.
Claim 6 is directed to the ADR of claim 6, where “one of the inferior
and superior surfaces of the respective endplate components is substantially
flat; and the corresponding surface of the spacer is also flat.” As shown in
Fig. 38 and 39, these limitations are described by Zdeblick (FF 15).
Claim 9 is directed to the ADR of claim 2, “wherein the spacer
component is composed of a polymer.” A hydrogel is a polymer and thus
meets all the limitations of claim 9 (FF 16, 17).
For the foregoing reasons, we affirm the rejections of claim 2, 6, and 9
as anticipated by Zdeblick. Claims 3-7, 10, and 14 fall with claim 2, 6, and 9
because separate arguments for their patentability were not presented. See
37 C.F.R. § 41.37(c)(1)(vii).

3. OBVIOUSNESS OVER PATIL
Claim 8 stands rejected under 35 U.S.C. § 103(a) as obvious over
Patil.
Findings of Fact
18. Claim 8 is directed to the ADR of claim 2, “wherein the spacer
component is composed of Nitinol.”
19. Patil does not describe its spacer as comprising nitinol.
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20. The Examiner states that the “use of nitinol is very well known in the
prosthesis art for biocompatibility” (Ans. 7).
21. The Examiner finds that “[i]t would have been obvious to one having
ordinary skill in the art at the time the invention was made to have made the
spring of a metal such as nitinol, since it has been held to be within the
general skill of a worker in the art to select a known material on the basis of
its suitability for the intended use, herein biocompatibility, as a matter of
obvious design choice. In re Leshin, 125 USPQ 416” (Ans. 4).

Analysis
During patent examination, the Examiner bears the initial burden of
establishing a prima facie case of obviousness. In re Kumar, 418 F.3d 1361,
1366 (Fed. Cir. 2005). In making an obvious determination, the Examiner
must first identity the scope and content of the prior art and then ascertain
the differences between the prior art and the claimed invention. Graham v.
John Deere Co., 383 U.S. 1, 17 (1966). Once the differences between the
prior art and the claimed invention have been identified, the next step is to
identify motivation or a reason why persons of ordinary skill in the art would
have been prompted to combine the prior art to have made the claimed
invention. KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007).
The Examiner has not established prima facie obviousness of claim 8.
The Examiner states that nitinol was well-known in the “prosthesis art”, and
that it would have been obvious to have produced a spacer composed of it as
required in claim 8 (FF 18, 20, 21), but provides no evidence that nitinol was
utilized in a prosthesis or specifically as a spacer material. KSR Int’l Co. v.
Teleflex Inc. did not relieve the Examiner of the burden under Graham v.
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John Deere Co. of establishing the elements of a claimed invention in the
scope and content of the prior art. Thus, we reverse the rejection of claim 8.

4. OBVIOUSNESS OVER ZDEBLICK
Claims 11-13 stand rejected under 35 U.S.C. § 103(a) as obvious over
Zdeblick.
Findings of Fact
22. Claim 11 is directed to the ADR of claim 2, “wherein the spacer
material is composed of a methacrylate.”
23. Claim 12 is directed to the ADR of claim 2, “wherein the spacer material
is composed of steric methylacrylate.”
24. Claim 13 is directed to the ADR of claim 2, “wherein the spacer material
expands due to a change in temperature.”
25. The Examiner acknowledges that Zdeblick does not describe the
features recited in claims 11-13, but states that it would have been obvious
to have selected the claimed materials “since it has been held to be within
the general skill of a worker in the art to select a known material on the basis
of its suitability for the intended use, herein hydrophilicity or ability to swell
due to a temperature change (e.g., heating to body temperature), as a matter
of obvious design choice. In re Leshin, 125 USPQ 416” (Ans. 4).
26. The Examiner states that the materials recited in claims 11 and 12 (FF
22, 23) were known in the prosthesis art (Ans. 8) and cites Stoy for evidence
that polymethacryic acid and derivatives had been used in spinal implants
(Ans. 8, citing Stoy, at col. 8, ll. 33-37 and cols. 9-10).
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27. The Examiner also states that the material recited in claim 13 (FF 24)
was known in the prosthesis art (Ans. 8) and cites Stoy as evidence of this
(Ans. 8, citing Stoy, at 7, ll. 59-67).

Analysis
Obviousness requires a reason for combining the prior art to have
made the claimed invention. In this case, the Examiner provides evidence
that the materials recited in claims 11, 12, and 13 were known in the art (FF
26, 27) and a reason why persons of ordinary skill in the art would have
utilized them in Zdeblick’s artificial disc (FF 25). We agree with the
Examiner’s rationale. When “a patent ‘simply arranges old elements with
each performing the same function it had been known to perform’ and yields
no more than one would expect from such an arrangement, the combination
is obvious.” KSR, 127 S. Ct. at 1740. Thus, we conclude that the Examiner
did not use “hindsight” reconstruction (see App. Br. 5-6) in setting forth the
rejection.
Appellant states that the evidence to support the rejection has not been
provided (App. Br. 5-6). However, the Examiner provides the Stoy
reference; Appellant does not identify a deficiency in it.
For the foregoing reasons, we affirm the rejection of claims 11-13 as
obvious over Zdeblick.

5. OBVIOUS-TYPE DOUBLE PATENTING
Claim 7 stands rejected under the judicially-created doctrine of
obvious-type double patenting as unpatentable over claim 3 of copending
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Application No. 10/303,385 (now U.S. Pat. No. 7,201,776, issued Apr. 10,
2007) in view of Zdeblick ‘785.
As Appellant has not argued this rejection, we summarily affirm it.

CONCLUSION
In summary, we affirm the rejections of claims 2-7, 9, 10, 14, and 15
as anticipated by prior art; claims 11-13 as obvious over prior art; and claim
7 over the judicially-created doctrine of obvious-type double patenting. We
reverse the obviousness rejection of claim 8.

TIME PERIOD
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:

GIFFORD, KRASS, SPRINKLE, ANDERSON & CITKOWSKI, P.C.
P.O. BOX 7021
TROY, MI 48007-7021
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