Ex Parte Hajaj et al

Patent Trial and Appeal Board

Nov 1, 2012

11684514 (P.T.A.B. Nov. 1, 2012)

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.
11/684,514 03/09/2007 Binyamin Hajaj 051892-0243 2934
7590 11/01/2012
MAKO SURGICAL CORP.
2555 DAVIE ROAD
FT. LAUDERDALE, FL 33317
EXAMINER
HOBAN, MELISSA A
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
11/01/2012 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
__________

Ex parte BINYAMIN HAJAJ, JASON K. OTTO,
RONY ABOVITZ, STEVEN B. BROWN,
SCOTT BANKS, BENJAMIN J. FREGLY,
and DANA C. MEARS
__________

Appeal 2011-002564
Application 11/684,514
Technology Center 3700
__________

Before ERIC GRIMES, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
prosthetic device for use in orthopedic joint replacement. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

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Statement of the Case
The Claims
Claims 16-29, 31-37, 39-50, 52-60, and 63-65 are on appeal. Claims
16 and 45 are representative and read as follows:
16. A prosthetic device configured to form at least a portion
of a joint, comprising:
a plurality of components configured to be implanted in
a body including at least one of multiple femoral components
to be implanted on a femur and multiple tibial components to
be implanted on a tibia, the plurality of components including:
a femoral component configured to be implanted
on a central region of the femur, and
a tibial component configured to be implanted on
a central region of the tibia,
wherein the femoral component configured to be
implanted on the central region of the femur includes a feature
configured to constrain a portion of the tibial component
configured to be implanted on the central region of the tibia,
wherein the tibial component configured to be
implanted on the central region of the tibia includes a feature
configured to constrain movement of the tibial component
configured to be implanted on the central region of the tibia
relative to at least a portion of the femoral component
configured to be implanted on the central region of the femur,
wherein each of the plurality of components is
configured to be fixed relative to a bone of the body and each
of the plurality of components is configured such that a
placement at which the component will be fixed relative to the
bone is not constrained by a connection to another of the
components that is fixed relative to the same bone, and
wherein the feature on the femoral component and the
feature on the tibial component are configured to cooperate to
provide the functionality of an excised posterior cruciate
ligament.

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45. A prosthetic device comprising:
a plurality of segmented components configured to
form at least a portion of a joint and including a first
segmented tibial component including a first contour and a
second segmented tibial component including a second
contour,
wherein the first contour includes a first lowpoint and
the second contour includes a second lowpoint, the first and
second lowpoints being configured to have different anterior
posterior locations when implanted on a bone of a patient,
wherein a portion of the first contour that includes the
first lowpoint is concave and a portion of the second contour
that includes the second lowpoint is concave, and
wherein each of the plurality of segmented components
is configured such that a placement of one of the segmented
components in the joint is not constrained by a connection to
another of the segmented components.

The issues

A. The Examiner rejected claims 16-29, 31-37, 39-50, 52-55, and 65
under 35 U.S.C. § 103(a) as obvious over Aram
1
and Wyss
2
(Ans. 4-9).
B. The Examiner rejected claims 56-60 under 35 U.S.C. § 103(a) as
obvious over Aram, Wyss, Colleran,
3
and Kuczynski
4
(Ans. 9-11).
C. The Examiner rejected claims 63 and 64 under 35 U.S.C. § 103(a) as
obvious over Aram, Wyss, and Chibrac
5
(Ans. 11).

1
Aram et al., US 2005/0154471 A1, published Jul. 14, 2005.
2
Wyss, J., US 2004/0162620 A1, published Aug. 19, 2004.
3
Colleran et al., US 5,871,546, issued Feb. 16, 1999.
4
Kuczynski et al., US 2006/0235537 A1, published Oct. 19, 2006.
5
Chibrac et al., US 6,540,786 B2, issued Apr. 1, 2003.
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A. 35 U.S.C. § 103(a) over Aram and Wyss
The Examiner finds that “Aram teaches the claimed prosthetic device
for replacing compartments of a knee (page 1, paragraph 0003), comprising
multiple femoral (16, 18, 20, 22, and 24) and tibial (26, 28, and 30)
components, which can be segmented and used independently and/or
jointly” (Ans. 4). The Examiner finds that “Aram also teaches that the
multiple femoral and/or tibial components are configured to be fixed relative
to a bone of the body and are not constrained by a connection to another of
the components” (id.).
The Examiner finds that “Aram does not teach wherein the feature on
the femoral component and the feature on the tibial component are
configured to cooperate to provide the functionality of an excised PCL” (id.
at 6). The Examiner finds that Wyss teaches that “in some cases, a patient‟s
knee lacks adequate posterior support due to deficient posterior cruciate
ligament (PCL)” (id.). The Examiner finds that Wyss teaches that “posterior
stabilization can be achieved in an implant by a projection or eminence
(feature) on the tibial insert that engages a box-like intercondylar portion
(feature) of the femoral component to inhibit dislocation of the joint at
hyper-extension or hyper-flexion” (id.).
The Examiner finds it obvious to “modify the invention of Aram to
include a feature on the tibial and femoral components configured to
cooperate to provide the functionality of an excised PCL, in order to achieve
posterior stabilization and inhibit dislocation of the joint at hyper-extension
or hyper-flexion, as taught by Wyss” (id. at 7). The Examiner finds it
obvious “to modify the prosthetic device of Aram by including a stop
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member and projection on the femoral and tibial components, respectively,
in order to provide optimum joint movement, as taught by Wyss” (Ans. 7).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that Aram and Wyss render obvious the
prosthetic device of claims 16 and 45?
Findings of Fact
1. Figure 1 of Aram is reproduced below:

“FIG. 1 depicts a patella femoral component and a tibial femoral
component” (Aram 2 ¶ 0025).
2. Aram teaches “component systems for replacing compartments
of a knee in total replacement surgery are well-known. . . . The femoral
component replaces the lateral condyle, medial condyle, and patellofemoral
portions of the femur because one or more of these areas of the knee are
diseased and are no longer wearing well” (Aram 1 ¶ 0003).
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3. Aram teaches that the
system 10 is comprised of a femoral replacement 12, a tibial
replacement 14, and a patellar replacement (not shown). The
femoral replacement 12 includes a patellofemoral joint (PFJ)
component 16, an upper lateral condyle component 18, an
upper medial condyle component 20, a lateral femoral
anterior/posterior condyle component 22, and a medial
femoral anterior/posterior condyle component 24. . . . The
tibial replacement 14 includes a medial meniscus component
26, a lateral meniscus component 28, and a tibial stem
component 30.

(Aram 5 ¶ 0116.)
4. Aram teaches that “„[c]omplimentary‟ replacement
components, as used herein, are defined to be components that can be used
independently and/or jointly, such that there is no need to remove previously
implanted components if additional components are needed at a later time”
(Aram 5 ¶ 0118).
5. Aram‟s Figure 42 is reproduced below:

“FIG. 42 depicts PFJ/condyle component 286 connected to spacer 288,
which is in turn connected to tibial component 290. Connection is made by
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connectors 292. The connectors between components may be bone, artificial
tissues and/or grafts” (Aram 8 ¶ 0156).
6. Aram‟s Figure 50 is reproduced below:

“As shown in FIG. 50, a medial meniscus 380 may be formed with a
concave surface 382 while the lateral meniscus 384 may be formed with a
convex surface 386. Such a configuration of meniscus components better
conform to normal knee anatomy” (Aram 9 ¶0165).
7. Wyss teaches that:
In some cases, the patient‟s knee lacks adequate posterior
support due to a deficient posterior cruciate ligament. In
these cases, the modular knee is preferably posteriorly
stabilized, meaning that posterior movement of the tibia
relative to the femur is restricted. This posterior stabilization
can be achieved in a typical implant by a projection or
eminence on the tibial insert that engages a box-like
intercondylar portion of the femoral component

(Wyss 1 ¶ 0006).
8. Wyss teaches that in “one feature of the femoral component 12
of the present embodiment, a tab 34 can be provided at the posterior end of
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the recess 32. The tab 34 can operate as a control for roll-back of the tibia
relative to the femur as the joint is articulated” (Wyss 2 ¶ 0028).
9. Figure 1 of Wyss is reproduced below:

“FIG. 1 is an exploded perspective view of the components of a joint
prosthesis” (Wyss 2 ¶ 0017).
10. Wyss teaches a “component of the prosthesis 10, namely the
stabilizing post 18. The stabilizing post 18 projects upward from the
intermediate component 16 to engage the intercondylar recess 32 in the
femoral component 12” (Wyss 3 ¶ 0032).
11. The Specification teaches that “the position of the tibial sagittal
lowpoint L can affect knee motion or kinematics. Depending on ligament
stability, the lowpoint L may need to be adjusted to provide appropriate knee
kinematics for a particular patient” (Spec. 19 ¶ 0067).
12. The Specification teaches that “medial and lateral tibial
lowpoints can be varied to meet the unique stability needs of the patient
and/or to match the femoral components” (Spec. 24 ¶ 0078).
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Principles of Law
“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., 550 U.S. 398, 416 (2007).
Analysis
Claim 16
Aram teaches a prosthetic device which includes multiple femoral
components for implantation on a femur and multiple tibial components for
implantation on a tibia (FF 1-3). At least some of Aram‟s components will
necessarily be implanted on the central region of the femur and tibia,
respectively (FF 1-3, Ans. 4).
Wyss teaches that:
In some cases, the patient‟s knee lacks adequate posterior
support due to a deficient posterior cruciate ligament. In
these cases, the modular knee is preferably posteriorly
stabilized, meaning that posterior movement of the tibia
relative to the femur is restricted. This posterior stabilization
can be achieved in a typical implant by a projection or
eminence on the tibial insert that engages a box-like
intercondylar portion of the femoral component

(Wyss 1 ¶ 0006; FF 7-10).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that an ordinary artisan would have reasonably found it obvious to
modify Aram‟s prosthetic insert to incorporate the posterior stabilization of
Wyss where the knee has a deficient posterior cruciate ligament in order to
prevent joint dislocation at hyper extension (FF 7-10; Ans. 7). Such a
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combination is merely a “predictable use of prior art elements according to
their established functions.” KSR, 550 U.S. at 417.
Appellants contend that “Aram and Wyss fail to teach or suggest a
compartmental prosthetic device having features that provide PCL
constraint, as required by independent claim 16” (App. Br. 5). Appellants
contend that:
It is erroneous to modify the compartmental device of
Aram based on the total knee device of Wyss in this manner.
There is no suggestion in Wyss (nor in Aram) to provide any
PCL constraint whatsoever in a compartmental device. The
embodiments of Aram that relate to a compartmental device
do not have any features that provide PCL constraint.
Conversely, the embodiments of Wyss that relate to PCL
constraint do not relate to a compartmental device. Even if
Aram and Wyss could be considered together, they do not
give any indication whatsoever that it would have been
obvious to provide a compartmental device with features
that provide PCL constraint.

(Id. at 5-6.)
We are not persuaded. Essentially, Appellants‟ contention is that since
Aram‟s knee prosthesis does not teach PCL constraint components, there is
no reason to incorporate the PCL constraint components from Wyss‟s knee
prosthesis into Aram‟s knee prosthesis. However, Wyss expressly teaches
components which prevent joint dislocation when the knee has a deficient
posterior cruciate ligament (FF 7-10; Ans. 7, 12). Thus, incorporation of the
PCL constraints of Wyss into Aram‟s prosthetic system would provide the
expected benefit of preventing joint dislocation when the posterior cruciate
ligament is torn, damaged, or removed. Consistent with KSR, this is a
specific reason articulated by the Examiner for incorporating this feature of
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Wyss‟s prosthetic knee into Aram‟s prosthetic knee. See KSR, 550 U.S. at
418 (There must be “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.”).
Appellants contend that “Aram and Wyss actually teach away from
providing PCL constraint in a compartmental device. One of ordinary skill
would have understood that such a modification would require a significant
amount of bone removal, which would defeat one of the primary purposes of
a compartmental device, namely, to conserve bone” (App. Br. 6).
We also do not find the teaching away argument persuasive. A
teaching away requires a reference to actually criticize, discredit, or
otherwise discourage the claimed solution. See In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004) (“The prior art‟s mere disclosure of more than one
alternative does not constitute a teaching away from any of these alternatives
because such disclosure does not criticize, discredit, or otherwise discourage
the solution claimed”). Appellants do not identify, and we do not find, any
teaching in the cited references which criticizes, discredits, or otherwise
discourages the claimed combination. Further, we agree with the Examiner
that the “modification might require the use of a large stem, however, the
combination of teachings of Aram and Wyss would necessarily motivate one
of ordinary skill in the art to try various types [of] constraining features, that
allow for the conservation of bone “ (Ans. 12). That is, we agree with the
Examiner that the stated desire of Wyss to prevent knee dislocation (FF 7) is
sufficient to suggest incorporation of those elements (FF 8-10) into Aram‟s
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knee prosthesis (FF 1-6) for the reasons discussed above even in the face of
some reduced bone conservation (see Ans. 12).
Claim 45
Appellants contend that “Aram and Wyss fail to teach or suggest a
prosthetic device having first and second contours with concave portions
having „first and second lowpoints being configured to have different
anterior posterior locations when implanted on a bone of a patient,‟ as
recited in independent claim 45” (App. Br. 7). Appellants contend that
while “Wyss may teach lowpoints at different medial-lateral locations, it
does not teach having them at different anterior-posterior locations. Wyss
provides no teaching of lowpoints at different anterior-posterior locations”
(id. at 9).
The Examiner finds that “it would have been obvious to one of
ordinary skill to include that both contours of the tibial component are
concave since the intention of a tibial component is to articulate with the
convex condyles of the femur or of a femoral component” (Ans. 6). The
Examiner finds that “Wyss teaches two concave contours” (id. at 13). The
Examiner also finds it obvious “to include different anterior posterior
locations of lowpoints, in order to better conform to normal knee anatomy,
as it is known in the art that often the lateral portion of a knee joint is not the
same as the medial portion” (id.). The Examiner finds it “clear that the
contours of a tibial component are meant to properly articulate with the
condyles of a femoral component and that the configuration of the contours
of the tibial component will vary depending on the anatomical requirements
of the patient” (id.).
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We conclude that the Examiner has the better position. We agree with
the Examiner that the selection of the contour of the components is patient
dependent, and that the use of different lowpoints at anterior-posterior
locations is patient dependent, and therefore obvious to the ordinary surgeon
depending upon the patient‟s specific anatomy. This is consistent with
Appellants‟ own Specification, which teaches that “the position of the tibial
sagittal lowpoint L can affect knee motion or kinematics. Depending on
ligament stability, the lowpoint L may need to be adjusted to provide
appropriate knee kinematics for a particular patient” (Spec. 19 ¶ 0067; FF
11). The Specification also teaches that “medial and lateral tibial lowpoints
can be varied to meet the unique stability needs of the patient and/or to
match the femoral components” (Spec. 24 ¶ 0078; FF 12). Thus, to the
extent that a surgeon selects lowpoints for the components, the ordinary
artisan would have recognized that these lowpoints will necessarily be
adjusted to meet the knee kinematics and stability needs of particular
patients (FF 11-12), rendering the claimed configuration an obvious
equivalent in the absence of evidence of secondary considerations.
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that Aram
and Wyss render obvious the prosthetic device of claims 16 and 45.
B. 35 U.S.C. § 103(a) over Aram, Wyss, Colleran, and Kuczynski
The Examiner finds it obvious to “modify the prosthetic device of
Aram in view of Wyss by specifying that at least one contour on the tibial
component has a radius between about 20mm to about 75mm, in order to
improve tibial-femoral contact area and reduce contact stress, as taught by
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Colleran” (Ans. 9-10). The Examiner finds it obvious to “include a contour
having a radius between about 76mm and 200mm and a flat portion, in order
to allow for misalignment and a decreasing amount of constraint at higher
degrees of flexion, as well as, to provide good cortical bone coverage for
matching regional anatomy, as taught by Kuczynski” (id. at 10-11).
In the Appeal Brief, Appellants point out that the “Examiner has not
cited Wyss in this rejection” regarding some deficiencies in the rejection
(App. Br. 10). However, the Examiner incorporated Wyss into the rejection
in the Examiner‟s Answer (see Ans. 9-10). Appellants do not dispute the
inclusion of Wyss into the rejection in the Reply Brief (see Reply Br. 10).
The Examiner provides sound fact-based reasoning for combining
Aram, Wyss, Colleran, and Kuczynski. We adopt the fact finding and
analysis of the Examiner as our own. Appellants‟ arguments are directed at
elements taught by Wyss as discussed in the primary rejection, but not at the
combination of Aram and Wyss with Colleran and Kuczynski. Therefore,
consistent with the rejection which we affirmed above, we affirm this
rejection for the reasons stated by the Examiner.
C. 35 U.S.C. § 103(a) over Aram, Wyss, and Chibrac
The Examiner finds it obvious “to include the option of locating the
tibial component in an anterior-posterior midplane, in order to allow the
surgeon to use his or her expertise and certain anatomical and kinematic
measurements for putting the prosthesis into place, as taught by Chibrac”
(Ans. 11).
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Appellants contend that “Chibrac provides no guidance for locating a
segmented tibial component in such positions” as required by claims 63 and
64 (App. Br. 11).
We note that the Examiner has now included Wyss in the rejection in
the Examiner‟s Answer, and that the Reply brief does not challenge this
inclusion as discussed above.
Also, as we discussed above, we agree with the Examiner that the
selection of the contour of the components is patient dependent, and that the
use of different lowpoints at anterior-posterior locations is patient
dependent, and therefore obvious to the ordinary surgeon depending upon
the patient‟s specific anatomy (FF 11-12).
SUMMARY
In summary, we affirm the rejection of claims 16 and 45 under 35
U.S.C. § 103(a) as obvious over Aram and Wyss. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 17-29, 31-37,
39-44, 46-50, 52-55, and 65, as these claims were not argued separately.
We affirm the rejection of claims 56-60 under 35 U.S.C. § 103(a) as
obvious over Aram, Wyss, Colleran, and Kuczynski.
We affirm the rejection of claims 63 and 64 under 35 U.S.C. § 103(a)
as obvious over Aram, Wyss, and Chibrac.

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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