Ex Parte Keller

Board of Patent Appeals and Interferences

Dec 4, 2008

10348322 (B.P.A.I. Dec. 4, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ARNOLD KELLER
____________

Appeal 2008-2812
Application 10/348,322
Technology Center 3700
____________

Decided: December 4, 2008
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and JEFFREY
N. FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 1-16, the only
claims pending in this application. We have jurisdiction under 35 U.S.C. §
6(b).

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Application 10/348,322

STATEMENT OF THE CASE
The claims are directed to an intervertebral prosthesis (claims 1-13
and 16) and a set of intervertebral prostheses (claims 14 and 15). Claims 1,
9, and 15 are illustrative:
1. Intervertebral prosthesis with at least one cover plate adapted to
bear on a vertebral body and is to be connected thereto, characterized in that
a cover plate surface directed toward the vertebral body has a bulge
protruding beyond the level of adaptation to the normal shape of the
vertebral body.

9. Intervertebral prosthesis according to claim 1, with at least one
cover plate which bears on a vertebral body and is to be connected thereto
and which has teeth intended to penetrate into the vertebral body,
characterized in that the distance of the teeth from the dorsal edge of the
cover plate is at least 20% of the cover plate size in the A-P direction.

15. Set of intervertebral prostheses which comprise at least one cover
plate which has a dorsal margin and which is adapted to bear on a vertebral
body and is to be connected thereto, characterized in that the set of
intervertebral prosthesis [sic] comprises at least one intervertebral prosthesis
on whose cover plate the dorsal margin is shortened compared to at least one
other intervertebral prosthesis in the set.

The Examiner relies on the following prior art references to show
unpatentability:
Gross et al. US 5,306,308 Apr. 26, 1994
Heggeness et al. US 5,514,180 May 7, 1996
Bryan WO 00/13619 Mar. 16, 2000
Suddaby US 6,395,034 B1 May 28, 2002

The rejections as presented by the Examiner are as follows:
1. Claims 1-8 and 12-16 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Heggeness.
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2. Claim 1 stands rejected under 35 U.S.C. § 102(e) as being anticipated by
Suddaby.
3. Claims 1-8, 15, and 16 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Bryan.
4. Claims 1 and 2 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Gross.
5. Claims 9-11 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Heggeness.
We affirm.

Anticipation:

ISSUES

As to claim 1, do Heggeness, Suddaby, Bryan, and Gross teach an
intervertebral prosthesis with at least one cover plate that has a bulge
protruding beyond the level of adaptation to the normal shape of the
vertebral body it is connected to?
As to claim 15, do Heggeness and Bryan teach an intervertebral
prosthesis whose dorsal margin is shortened compared to at least one other
intervertebral prosthesis in the set?

FINDINGS OF FACT
1. “The cover plates of the vertebral bodies between which the
intervertebral disks of the spinal column are situated are generally flat or
slightly concave” (Spec. 1: 6-8).
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2. Appellant’s Specification discloses that
[A]fter an intervertebral disk prolapse, the margin of a vertebral
body impinges on the cover plate of the adjacent vertebral body
and grinds out a depression there. Regardless of how the
pronounced concavity has arisen, it leads to inadequate support
of the dorsal margin, from which osteophytes may also project
in some cases. If a prosthesis is now introduced into the
intervertebral space, it can easily happen that the dorsal edge of
the prosthesis impacts against the inadequately supported
margin of the vertebral body or against osteophytes and thus
breaks off part of the bone in the direction of the medullary
canal, where it poses a danger to the spinal cord. The same
thing can also happen if the prosthesis is implanted and,
because of its insufficient support in the area of the depression,
places too great a load on the margin of the vertebral body.

(Spec. 1: 13-29.)

3. Appellant discloses that a solution to the problem is to utilize an
intervertebral prosthesis that has
[A] bulge which positions itself in a depression in the bone of
the vertebral body in order on the one hand to obtain an
improved support for the prosthesis there and on the other hand
to protect the projecting bone margin next to the depression.
This bulge rises above the usually flat basic shape, or, in
adaptation to the natural shape of the vertebral, at the very most
slightly concave basic shape, of the cover plate surface. The
bulge is compared to the flat or only slightly concave shape of
the cover plates of the vertebral bodies or compared to
prosthetic cover plates intended for normal cases of use.

(Spec. 2: 8-20.) “The bulge should be approximated as far as possible to the
shape of the depression which is to receive it” (Spec. 2: 35-36).
4. Appellant discloses that
What is to be considered as a bulged cover plate and what is to
be considered as a normal cover plate surface must be
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determined by comprison [sic] between the normal prostheses
and the bulged prostheses of one and the same set of prostheses.
The cover plate surfaces which are intended to bear on the
vertebral body are in most cases basically flat. In some cases,
the normal cover plate surface has a slight convex curve which
complements the average curvature of the vertebral body
surfaces. The bulge is then the convex area which rises above a
correspondingly naturally flat or slightly curved imaginary
surface of the cover plate.

(Spec. 8: 24-31.)
5. Heggeness teaches “prosthetic intervertebral devices designed to
accommodate the specific morphological anatomy of vertebral end-plates”
(Heggeness, col. 4, ll. 17-19). Heggeness teaches implants that “comprise
specific contoured inferior and superior surfaces which are capable of
accommodating the defined morphological anatomy of a given superior and
inferior vertebral endplate, respectively” (Heggeness, col. 4, ll. 27-31).
Heggeness implants have contours or shapes that “may be categorized into
five groups: ‘ramp,’ ‘saddle,’ ‘irregular,’ ‘bowl,’ and ‘hump” (Heggeness,
col. 6, ll. 59-62).
6. For clarity we reproduce Heggeness figure 22 below:

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“FIG. 22 illustrates [an] . . . intervertebral device designed to reconstruct a
corpectomy” (Heggeness, col. 5, ll. 66-67). Heggeness teaches that
[T]he superior surface (64) of the top end (61) has a fixed shape
to accommodate substantially defined contours of an inferior
vertebral endplate (e.g., “bowl” and “hump”), and the inferior
surface (63) of the bottom end (62) has a fixed shape to
accommodate substantially defined contours of a superior
vertebral endplate (e.g. “saddle,” “ramp,” and possibly
“irregular”).

(Heggeness, col. 10, ll. 29-35.)

7. Suddaby teaches an intervertebral disc replacement device with convex
heads (Suddaby, Abstract). Suddaby teaches that while “vertebral endplate
surfaces are normally concave,” “the geometry of the head (i.e., its radius of
curvature) should be chosen to match that of the vertebral endplate against
which it will bear” (Suddaby, col. 4, ll. 4-7).
8. Bryan teaches an intervertebral prosthetic device that provides a
“geometry to engage concave mating surfaces on the vertebral bodies or
bones so as to provide proper stability and proper positioning of the
opposing engaged vertebrae or vertebral bodies” (Bryan 2: 16-18).
9. For clarity we reproduce Bryan’s figures 1, 2, and 4 below:

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“Figure 1 is a top plan view of . . . [Bryan’s] spinal prosthesis. Figure 2 is
an end view of the prosthesis shown in figure 1. . . . Figure 4 is an exploded
view of [Bryan’s] prosthesis” (Bryan 3: 11-15). According to Bryan
[V]iscoelastic discs 41, 42 are interposed between the upper
half housing 22 and the lower half housing 24 to maintain the
housing halves separate from one another and to provide for a
defined range of motion between the housing halves. . . . If
desired, generally conical bosses or posts 29 can fit into
recesses 33 formed in the discs 41, 42 to provide stability and
limitation against excessive motion.

(Bryan 3: 1-8.)

10. Gross teaches “[a]n intervertebral implant consisting of a disc-shaped
spacer . . . insertable between opposed and adjacent vertebrae in which the
opposing sides . . . of the implant bordering the vertebrae are circular discs
and have a central raised dome” (Gross, Abstract). Gross teaches that “both
the size and the shape of the raised dome are formed in accordance with the
anatomical conditions of the vertebrae, in order that the raised dome can
then be firmly pressed into the inner softer tissue of the vertebrae” (Gross,
col. 1, l. 65 - col. 2, l. 1).

PRINCIPLES OF LAW
“[I]n an ex parte proceeding to obtain a patent, . . . the Patent Office has
the initial burden of coming forward with some sort of evidence tending to
disprove novelty.” See In re Wilder, 429 F.2d 447, 450 (CCPA 1970).
Nevertheless, “when the PTO shows sound basis for believing that the
products of the applicant and the prior art are the same, the applicant has the
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burden of showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed.
Cir. 1990) (emphasis added).
Anticipation requires the disclosure, expressly or inherently, of all the
limitations of a claimed invention in a prior art reference. Verdegaal Bros.,
Inc. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed. Cir. 1987) (“A
claim is anticipated only if each and every element as set forth in the claim is
found, either expressly or inherently described, in a single prior art
reference.”).
It is well settled that argument by counsel cannot take the place of
evidence. In re Cole, 326 F.2d 769, 773 (CCPA 1964); In re Geisler, 116
F.3d 1465, 1471 (Fed. Cir. 1997).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii)
(“Any arguments or authorities not included in the brief or a reply brief ...
will be refused consideration by the Board, unless good cause is shown.”).

ANALYSIS
Heggeness:
Appellant provides separate arguments for claims 11 and 15. Claims
2-8, 12-14, and 16 stand or fall together with claim 1. 37 C.F.R.
§ 41.37(c)(1)(vii).

1 Appellant argues the limitations of claim 14 with claim 1 (App. Br. 10-11).
Accordingly, we group claim 14 with claim 1.
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Claim 1:
Appellant contends that “[t]he prosthesis in Heggeness does not
protrude beyond the level of adaptation as explicitly recited in” claim 1
(App. Br. 11). We are not persuaded.
The intervertebral prosthesis of claim 1 has at least one cover plate
that has a bulge protruding beyond the level of adaptation to the normal
shape of the vertebral body (claim 1). “The cover plates of the vertebral
bodies . . . are generally flat or slightly concave” (FF 1). When damaged the
cover plates of the vertebral bodies can take on a conformation that is no
longer flat or slightly concave (FF 2). According to Appellant’s
Specification a bulged cover plate is considered in relation to a normal cover
plate that is generally flat or slightly concave (FF 1, 3, and 4). Thus, claim 1
reads on any intervertebral device that has a cover plate that is not flat or
slightly concave.
Heggeness’ prosthetic device is designed to accommodate the specific
morphological anatomy of vertebral end-plates and can take on contours or
shapes that can be categorized as a “ramp,” “saddle,” “irregular,” “bowl”
and “hump” (FF 5 and 6). Stated differently, Heggeness’ prosthetic device
has a bulged cover plate that is not generally flat or slightly concave, e.g., a
“normal” cover plate. Instead, Heggeness teaches that the prosthetic device
is adapted to conform to a patient’s need, which may be of a variety of
different shapes including bulges protruding beyond the level of adaptation
to “the normal shape of the vertebral body” as is required by Appellant’s
claim 1.
We find no error in the Examiner’s prima facie case. Arguments not
made are waived. 37 C.F.R. § 41.37(c)(1)(vii).
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Claim 15:
Appellant contends that the
Examiner equates the shortened dorsal margin with a lessened
height where, as shown in Heggeness’ Figs. 22 and 23, one side
of cover plate 61 or 62 is shown to be shorter than the other.
However, this is a misreading of Applicant’s claim. The dorsal
margin is the distance the cover plate extends in the dorsal
direction.

(App. Br. 11.) We are not persuaded.
The Examiner finds that “the claim does not specify any direction the
dorsal margin must be shortened in. Therefore, even a dorsal margin
shortened in height reads on the claims” (Ans. 7). We agree. Appellant has
not identified, and we do not find, a disclosure in their claim or Specification
that would limit the meaning of a shortened dorsal margin to “the distance
the cover plate extends in the dorsal direction” (App. Br. 11). Argument by
counsel cannot take the place of evidence. In re Cole, 326 F.2d at 773
(CCPA 1964); In re Geisler, 116 F.3d at 1471 (Fed. Cir. 1997). Arguments
not made are waived. 37 C.F.R. § 41.37(c)(1)(vii).

Suddaby:
Appellant contends that Suddaby’s bulge “is chosen to match the
vertebral endplate against which it will bear” (App. Br. 12). We agree (FF
7). Suddaby teaches that the vertebral endplate of the device is chosen to
match the patient’s endplate (FF 1 and 7). If a patient’s endplate is not
generally flat or slightly concave (e.g., non-normal) (FF 2), the result would
be an intervertebral device which has a bulge protruding beyond the level of
adaptation to the normal shape of the vertebral body.
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We find no error in the Examiner’s prima facie case. Arguments not
made are waived. 37 C.F.R. § 41.37(c)(1)(vii).

Bryan:
Appellant provides separate arguments for claims 1 and 15. Claims 2-
14 and 16 stand or fall together with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

Claim 1:
Appellant contends that “[t]he bulge shown in Figures 3, 4, and 6 of
Bryan is not shown to be protruding beyond the level of adaptation to the
normal shape of the vertebral body” (App. Br. 12). We are not persuaded.
Bryan teaches an intervertebral prosthetic device that provides a “geometry
to engage concave mating surfaces on the vertebral bodies or bones so as to
provide proper stability and proper positioning of the opposing engaged
vertebrae or vertebral bodies” (FF 8). Thus, in a patient whose vertebral
bodies are not “normal” (e.g., generally flat or slightly concave) (FF 2),
Bryan teaches that the intervertebral prosthetic device provides a mating
surface for the vertebral bodies or bones so as to provide proper stability and
positioning (FF 1 and 8). Appellant identifies no evidence on this record to
suggest that Bryan’s intervertebral prosthetic device does not protrude
beyond the level of adaptation to a normal shaped vertebral body. Thus, the
preponderance of the evidence falls in favor of the Examiner. Arguments
not made are waived. 37 C.F.R. § 41.37(c)(1)(vii).

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Claim 15:
Appellant contends that Bryan fails to teach “a set of prosthesis”
(App. Br. 13). We disagree. Bryan’s prosthesis set comprises elements 22,
24, 29, 41, and 42 as illustrated in Bryan’s Fig. 2 and Fig. 4 (FF 9).
Appellant contends that “there is no cover plate where the dorsal margin is
shortened compared to at least one other intervertebral prosthesis in the set
and there is no disclosure of this in the specification of Bryan” (App. Br.
13). We are not persuaded. Claim 15 requires a cover plate whose dorsal
margin is shortened compared to at least one other intervertebral prosthesis
in the set. The Examiner finds that “Bryan discloses an intervertebral
prosthesis (20) having a shorter dorsal side (see fig. 1-4) than another
prosthesis (41, 42)” in the set (Ans. 4; FF 9). We find no error in the
Examiner’s prima facie case. Arguments not made are waived. 37 C.F.R.
§ 41.37(c)(1)(vii).

Gross:
Appellant contends that Gross fails to teach a bulge that “protrude[s]
beyond the level of adaptation to the normal shape of the vertebral body”
(App. Br. 13). We are not persuaded. Gross teaches that “both the size and
the shape of the raised dome are formed in accordance with the anatomical
conditions of the vertebrae, in order that the raised dome can then be firmly
pressed into the inner softer tissue of the vertebrae” (FF 10). Thus, in a
patient whose vertebral bodies are not “normal” (e.g., generally flat or
slightly concave) (FF 2), Gross teaches that the vertebral endplate of the
device is chosen to match the patient’s non-normal endplate (FF 10).
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We find no error in the Examiner’s prima facie case. Arguments not
made are waived. 37 C.F.R. § 41.37(c)(1)(vii).

CONCLUSIONS OF LAW
As to claim 1, Heggeness, Suddaby, Bryan, and Gross teach an
intervertebral prosthesis with at least one cover plate that has a bulge
protruding beyond the level of adaptation to the normal shape of the
vertebral body it is connected to.
The rejection of claim 1 under 35 U.S.C. § 102(b) as being anticipated
by Heggeness is affirmed. Claims 2-8, 12-14, and 16 fall together with
claim 1.
The rejection of claim 1 under 35 U.S.C. § 102(e) as being anticipated
by Suddaby is affirmed.
The rejection of claim 1 under 35 U.S.C. § 102(b) as being anticipated
by Bryan is affirmed. Claims 2-8, and 16 fall together with claim 1.
The rejection of claim 1 under 35 U.S.C. § 102(b) as being anticipated
by Gross is affirmed. Since it is not separately argued, claim 2 falls together
with claim 1.
As to claim 15, Heggeness and Bryan teach an intervertebral
prosthesis whose dorsal margin is shortened compared to at least one other
intervertebral prosthesis in the set.
The rejection of claim 15 under 35 U.S.C. § 102(b) as being
anticipated by Heggeness is affirmed.
The rejection of claim 15 under 35 U.S.C. § 102(b) as being
anticipated by Bryan is affirmed.

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Obviousness:
ISSUE
Did the Examiner err in concluding that claims 9-11 are prima facie
obvious over Heggeness?

PRINCIPLES OF LAW
In proceedings before the Patent and Trademark Office, the Examiner
bears the burden of establishing a prima facie case of obviousness based
upon the prior art. On appeal to this Board, Appellant must show that the
Examiner has not sustained the required burden.2
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1739 (2007).
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

Id. at 1742. It is proper to “take account of the inferences and creative steps
that a person of ordinary skill in the art would employ.” Id. at 1741. See

2 See (1) Ex parte Yamaguchi, Appeal 2007-4412, slip op. at 5 and 23
(BPAI Aug. 29, 2008); (2) Ex parte Fu, Appeal 2008-0601, slip op. at 5 and
20 (BPAI Mar. 31, 2008); (3) Ex parte Catan, Appeal 2007-0820, slip op. at
3 and 21 (BPAI Jul. 3, 2007) and (4) Ex parte Smith, Appeal 2007-1925, slip
op. at 4, 9 and 23 (BPAI Jun. 25, 2007). Opinions in support of the
decisions in these four appeals are (a) precedential opinions of the Board and
(b) available on the USPTO website.
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also id. at 1742 (“A person of ordinary skill is also a person of ordinary
creativity, not an automaton.”). “In determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).

ANALYSIS
Appellant contends that “[c]laims 9-11 depend from, and contain all
the limitations of claim 1. These dependent claims also recite additional
limitations which, in combination with the limitations of claim 1, are neither
disclosed nor suggested by Heggeness and are also believed to be directed
towards the patentable subject matter” (App. Br. 11, n. 2). Having found no
error in the Examiner’s prima facie case of anticipation of claim 1 over
Heggeness, we are not persuaded by Appellants’ argument. Since Appellant
failed to particularly point out any other reason why claim 9 should not be
considered prima facie obvious over Heggeness; we find no error in the
Examiner’s prima facie case of obviousness.

CONCLUSION OF LAW
The Examiner did not err in concluding that claims 9-11 are prima
facie obvious over Heggeness.
The rejection of claim 9 under 35 U.S.C. § 103(a) as being
unpatentable over Heggeness. Since they are not separately argued, claims
10 and 11 fall together with claim 9.
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CONCLUSION
In summary, we affirm all rejections of record.
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

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