Ex Parte Bertagnoli et al

Board of Patent Appeals and Interferences

Jul 10, 2012

11150468 (B.P.A.I. Jul. 10, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RUDOLPH BERTAGNOLI, THIERRY MARNAY,
CHRISTOPHE GEISERT, EDUARD KUFELD,
and BARBARA SCHWEIZER
__________

Appeal 2011-005326
Application 11/150,468
Technology Center 3700
__________

Before MELANIE L. McCOLLUM, JEFFERY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to a method for customizing an intervertebral implant and a
method for providing a custom designed intervertebral implant. The Patent
Examiner rejected the claims for obviousness. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
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STATEMENT OF THE CASE
Claims 1-13, 15, 17, and 18 are on appeal. Claim 1 is representative
and reads as follows:
1. A method for customizing an intervertebral implant to be implanted in
a series of vertebrae, the series of vertebrae including an abnormal vertebra,
a vertebra superior to the abnormal vertebra, and a vertebra inferior to the
abnormal vertebrae, where the series of vertebrae has a deformed curvature
in comparison to a known natural curvature of the series of vertebrae, said
method comprising the steps of:
a) obtaining a 3D anatomy of the series of vertebrae in a computer;
b) repositioning of the abnormal, superior and inferior vertebrae of the
3D anatomy of the series of vertebrae in the computer to eliminate the
deformed curvature of the series of the vertebrae so as to arrange the series
of vertebrae in the natural curvature;
c) determining whether a superior or inferior surface of the abnormal
vertebra is an abnormal surface causing the deformed curvature of the series
of vertebrae;
d) determining an approximate gap between the abnormal surface of
the abnormal vertebra and a desired surface of the abnormal vertebra;
e) custom constructing a trial implant to engage the abnormal surface
and to fill the determined approximate gap, whereby implantation of the trial
implant between the abnormal surface of the abnormal vertebra and adjacent
surface of one of the superior and inferior vertebrae of the series vertebrae
results in the series of vertebrae being arranged in the natural curvature, said
custom constructing of the trial implant step including the step of providing,
on surface of the trial implant which respectively engage the abnormal
surface and the adjacent surface, slots therein for reception of a cutting tool
used to cut keel grooves in the abnormal surface and the adjacent surface;
and
f) custom constructing the intervertebral implant to engage the
abnormal surface and to fill the determined approximate gap, whereby
implantation of the intervertebral implant between the abnormal surface and
the adjacent surface likewise results in the series of vertebrae being arranged
in the natural curvature, said custom constructing of the intervertebral
implant step including the step of providing, on endplates of the
intervertebral implant which respectively engages the abnormal surface and
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the adjacent surface, keels extending therefrom which are to be received in
the keel grooves.

The Examiner rejected claims 1-13, 15, 17, and 18 under 35 U.S.C.
§ 103(a) as unpatentable over Marik
1
and Eufinger.
2

OBVIOUSNESS
The Issues
The Examiner’s position is that Marik taught a method for
customizing an intervertebral implant for abnormal vertebrae as claimed,
except that
Marik does not specifically teach the steps of obtaining a 3D
anatomy of the series of vertebrae in a computer (part of step a); and
repositioning the abnormal, superior and inferior of the 3D anatomy
of the series of vertebrae in the computer to eliminate the deformed
curvature so as to arrange the series of vertebrae in the natural
curvature (part of step b) and contouring surfaces of the implant to
response to the repositioning.

(Ans. 5.) The Examiner found however that
Eufinger teaches a method of custom constructing an implant
including the steps of obtaining a 3D anatomy in a computer;
repositioning the 3D anatomy in the computer to manipulate the
abnormal surface to match the desired surface; then custom
constructing the implant based on the data collected (see figs. 2, 4, 5
and note col. 5 lines 3-14 and line 47- col. 6 line 8) in order to
efficiently and cost effectively construct a customized implant as the
computer is able to determine the appropriate size implant rather than
the surgeon figure this out via tr[ia]l and error with the trial implants.

1
Marik et al., US 2005/0055029 A1, published Mar. 10, 2005.
2
Eufinger et al., US 5,798,924, issued Aug. 25, 1998.
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(Id.) The Examiner concluded that “[i]t would have been obvious to one of
ordinary skill in the art at the time the invention was made to modify the
method of Marik with the use of a computer to customize the construction of
an implant in view of Eufinger in order to efficiently and
more cost effectively custom construct an implant and trial implant for a
patient.” (Id.)
Appellants argue the rejection should be withdrawn because Marik
and Eufinger fail to teach or suggest these four features of the invention:
A. the steps of 1) determining an approximate gap between the abnormal
surface of the abnormal vertebra and a desired surface of the abnormal
vertebra, and 2) custom constructing (or designing) a trial implant to
engage (or match) the abnormal surface and to fill the determined
approximate gap, as recited in independent claims 1, 7, and 11 (App.
Br. 7);
B. that custom constructing of the trial implant step includes the step of
providing, on surface of the trial implant which engages the abnormal
surface and the adjacent surface, slots therein for reception of a
cutting tool used to cut keel grooves in the abnormal surface and the
adjacent surface, as recited in independent claims 1, 7, and 11 (id. at
7-8);
C. the step of repositioning of the abnormal, superior and inferior
vertebrae of the 3D anatomy of the series of vertebrae in the computer
to arrange the series of vertebrae in a natural curvature, as recited in
independent claims 1, 7, and 11 (id. at 8-9); and
D. the step of custom constructing the intervertebral implant to engage
the abnormal surface and to fill the determined approximate gap
(claims 1 and 11) or constructing the engaging surface of the
intervertebral implant to match the abnormal surface in repositioned
3D anatomy (claim 7) (id at 9).

Findings of Fact
1. We adopt the Examiner’s findings concerning the scope and content
of the prior art. (Ans. 3-10.)
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Analysis
A. Appellants focus on Marik’s teaching of trial implants used until a
select one of the trial implants fits to argue that Marik did “not custom
construct or design a trial implant to fill a determined gap.” (App. Br. 7.)
“Even if it is found that by inserting a plurality of trial implants until one of
the trial implant fits, Marik determines a gap, Appellants assert that the
determined gap is not a difference between a vertebral surface in its
abnormal state and the vertebral surface in its desired state. Rather, the trial
implant is merely sized to fit in an intervertebral space once the disc material
has been removed.” (Id.) According to Appellants, Eufinger taught
customizing a cranial implant and “does not cure the deficiency of Marik as
applied to these claim elements.” (Id.)
The rejection pointed out that Marik’s method included a step of
“performing pre-operative planning” (see step 80 in Marik’s Figure 10), and
explained how Eufinger’s computerized visualization and adjustment
method of customizing an implant before an operation would improve
Marik’s trial and error process that used trial implants. (Ans. 4-5.) Thus the
Examiner found Appellants’ argument “A” unpersuasive. (Ans. 7-8.) We
find the Examiner’s reasoning more persuasive than Appellants’ separate
analyses of the references in isolation, because the Examiner reasonably
explained how the teachings of both references would have informed the
artisan and would have fairly suggested the claimed steps. It is unclear
whether Appellants intend their focus on Eufinger’s jaw implant to suggest
that Eufinger’s disclosure was irrelevant to Marik’s spinal work. We find
Eufinger reasonably pertinent to the problem Marik addressed and the
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problem Appellants address. See In re Clay, 966 F.2d 656, 658-9 (Fed. Cir.
1992).
B. Appellants contend that “Marik fails to teach or suggest that custom
constructing the trial implant includes the step of providing, on the surface
of the trial implant, slots therein for reception of a cutting tool.” (App. Br.
8.)
As evidence that Marik disclosed this feature, the rejection directed
attention to Marik’s ¶¶ [0047] - [0049]. Marik’s ¶ [0047] explained:
Referring to FIG. 17, once the appropriate sized implant trial 116 is
determined, the correspondingly sized rail cutter guide 118 is selected
and used to prepare one or more fin or rail channels in the endplates in
correspondence with the fin or rail member on the artificial disc
system.

(See Ans. 4.) A relevant detail from Marik’s Figure 17 is reproduced here:

Figure 17 is a “representation[] of a rail cutter guide and method for
forming one or more fin or rail guide channels in one or both end
plates adjacent to the prepared disc space.” (Marik 2, ¶ [0025].)

Marik’s ¶ [0048] stated:
Referring to FIGS. 17-22, one embodiment of a rail cutter
guide 118 includes at least one machining guide 120 positioned on
guide body 122 and having a size 124 to provide a reference to a bone
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cutting device 126 to form a fin or rail member channel 128 in one or
both adjacent vertebrae 98, 100 corresponding in position and size to
the fin or rail guide member on the artificial spinal disc system. . . .
Further, rail cutter guide 118 may include a spacer portion 130 sized
and having a thickness 132 (FIG. 20) corresponding to a desired disc
spacing, such as the natural neutral disc spacing of the prepared disc
space 114. Additionally, guide body 122 or spacer portion 130 may
include predetermined recesses 131 sized to accommodate at least a
portion of a bone removal device. Rail cutter guide 118 may further
include a permanent or removably attachable handle 134 for
manipulating the position of the guide.

(Marik 5, ¶ [0048].) Marik’s Figure 20 is reproduced here:

“FIGS. 19-20 are representations of a bone removal mechanism being
utilized in conjunction with the rail cutter guide of FIGS. 17-18.”
(Marik 2, ¶ [0026].)

The evidence cited in the rejection, reproduced above, shows that
Marik referred to a trial implant 116 and a correspondingly sized rail cutter
guide 118. Claim 1, step “e)” recites “custom constructing of the trial
implant step including the step of providing, on surface of the trial implant
which respectively engage the abnormal surface and the adjacent surface,
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slots therein for reception of a cutting tool used to cut keel grooves in the
abnormal surface and the adjacent surface.” The Examiner found
Appellants’ argument unpersuasive because “Marik teaches the use of a trial
implant with slots (e.g. 123 and 131) corresponding to the implant used to
cut keel grooves into the bone.” (Ans. 8.) We agree with the Examiner that
Marik’s recess 131 in the rail cutter guide 118 is a slot. Marik taught that
the slotted rail cutter guide 118 is sized to match the trial implant 116, or in
other words, the rail cutter guide is a slotted trial implant. Thus the
difference between Marik’s rail cutter guide 118 with slots and Appellants’
claimed trial implant with slots is the name. The difference in names here is
not a patentable distinction.
C. Appellants contend:
Eufinger teaches computer modeling, however it does not obtain a
deformed 3D anatomy and a repositioned 3D anatomy. Rather,
Eufinger discloses that a reference model is available in a storage
medium or acquired computertomographically from a physically
existing reference model (see Col. 4, lines 51-59). The present claims
require the step of repositioning the 3D anatomy of the series of
vertebrae in the computer to the natural curvature.
Accordingly, even if the teachings of Eufinger were
incorporated into Marik, the combination would not include the step
of repositioning the abnormal vertebrae to the natural curvature.
Rather, based on the teachings of Eufinger, the abnormal vertebra of
Marik would be compared to a reference model available in a storage
medium or acquired computertomographically from a physically
existing reference model.

(App. Br. 8.)
The passage in Eufinger that Appellants cite, col. 4, ll. 51-59, deals
with data acquisition in process step A1, but does not explain any of
Eufinger’s subsequent process steps B through E. The rejection cited
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portions of Eufinger’s disclosure at column 5, ll. 3-14, and the paragraph
bridging columns 5 and 6. (Ans. 5.) In the first of those passages, Eufinger
described its process step C, in which images are manipulated:
part areas of the interface of the actual model are displaced by an
interactive CAD modeling and manipulating method in the direction
of the volume of the reference model. Recesses and hollow spaces are
produced in this way in the regions of the endoprosthesis where no
contact is desired with the existing bone structure. Likewise,
projections and/or undercuts of the endoprosthesis to be produced can
be removed, which can be seen in advance to pose problems when the
endoprosthesis; is inserted.

(Eufinger, col. 5, ll. 3-14). In the second of those passages, Eufinger further
explained that
It is possible to place through the two superimposed models 10 and 14
any desired sections, on the basis of which the adaptation and the
subsequent fine adaptation is made in the critical sites. The adaptation
essentially takes place by support point displacement The fine
adaptation is accomplished by geometric manipulation functions
(reflecting, expending, turning, rounding, smoothing etc.). The
adaptation is made in a way such that the height and position in the
direction of the sagittal and transversal planes as well as the recesses
of exit regions of the sensitive nerves of the lower jaw are adapted to
the shape of the endoprosthesis to be produced.

(Eufinger, col. 5, l. 51 – col. 6, l. 5.)
Based on the Eufinger disclosures cited in the rejection, the Examiner
found that Eufinger in fact did teach repositioning, contrary to Appellants’
contentions. (Ans. 9.) The evidence supports the Examiner. Appellants’
argument cites only to Eufinger’s data acquisition step, and does not take
into account the geometric manipulation of images that Eufinger taught.

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D. Appellants contend: “Rather than contour the artificial disc, Marik
contours the end plates of the vertebrae (see Paragraph 44). In particular, a
contouring device 105 is utilized to form a predetermined contour 108, 110
which may generally correspond to the bone contacting surface of the
artificial disc. Thus, customizing a vertebral implant is not taught in Marik,
and in fact Marik teaches away from such a customizing step.” (App. Br. 9.)
The Examiner responds that the application of Eufinger’s method to
Marik’s subject would have suggested this step: “This is accomplished by
analyzing an anatomical deformity of a bone in a computer by
superimposing an actual model of this anatomy onto a reference model of
the anatomy and using a computer to manipulate the actual model as needed
in order to custom construct the appropriate implant in order to efficiently
and cost effectively construct a customized implant.” (Ans. 10, citing
Eufinger.)
Appellants’ focus on Marik alone is unpersuasive. The evidence
supports the Examiner’s finding that Eufinger suggested computer imaging
for customizing bone implants. Appellants’ allegation that Eufinger “does
not cure the deficiency of Marik” (App. Br. 9) is also unpersuasive in view
of the Examiner’s reasoning. Finally, there is no evidence that Marik taught
away from applying Eufinger’s image manipulation strategy to spinal
implants.
Claims 2-6, 8-10, 12, 13, 15, 17, and 18 have not been argued
separately and therefore fall with claim 1, 7 or 11, respectively. 37 C.F.R.
§ 41.37(c)(1)(vii).

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SUMMARY
We affirm the rejection of claims 1-13, 15, 17, and 18 under
35 U.S.C. § 103(a) as unpatentable over Marik and Eufinger.
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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