Ex Parte de la Barrera et al

Patent Trial and Appeal Board

Apr 26, 2018

11290039 (P.T.A.B. Apr. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111290,039 11130/2005 Jose Luis Moctezuma de la Barrera
27305 7590 04/30/2018
HOW ARD & HOW ARD ATTORNEYS PLLC
450 West Fourth Street
Royal Oak, MI 48067
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
29997-067 7093
EXAMINER
IWAMAYE, ANDREW MICHAEL
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
04/30/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
IPDocket@HowardandHoward.com
dtrost@HowardandHoward.com
tmorris@Howardandhoward.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSE LUIS MOCTEZUMA DE LA BARRERA,
STUART LEE AXELSON JR., and PETER ZIMMERMAN1
Appeal2017-003315
Application 11/290,039
Technology Center 3700
Before JEFFREY N. FREDMAN, RYAN H. FLAX, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims to a method for performing arthroplasty on a knee joint using a
surgical navigation system. 2 The Examiner's rejection of claims 1, 5, 8, 10-
12, 15, 17-24, 28-39, 42--48, 50-52, 55, and 60-67 under 35 U.S.C.
§ 103(a) is appealed. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the Real Party in Interest as "Stryker European
Holdings I, LLC." Appeal Br. 1.
2 We herein refer to the Specification filed on Nov. 30, 2005 ("Spec."); Final
Office Action mailed Nov. 27, 2015 ("Final Action"); Appeal Brief filed
June 27, 2016 ("Appeal Br."); Examiner's Answer mailed Nov. 3, 2016
("Answer"); and Reply Brief filed Jan. 2, 2017 ("Reply Br.").
Appeal2017-003315
Application 11/290,039
STATEMENT OF THE CASE
The Specification states "this invention relates to methods, and
software to assist in surgical reconstructive interventions of joints that have
kinematic behavior influenced by the soft tissue apparatus surrounding it."
Spec. ,-r 4.
Independent claim 1, reproduced below, is representative:
1. A method for performing arthroplasty on a joint
comprising a knee using a surgical navigation system, the
method including the steps of:
locating a femur and a tibia of the knee using the surgical
navigation system;
determining biomechanical properties of the joint;
evaluating soft tissue envelope properties for the joint;
calculating a solution using the biomechanical properties,
the soft tissue envelope properties and a functional goal;
choosing an implant for the knee based at least partly on
the solution;
displaying an interactive view of the joint, the soft tissue
envelope properties, the biomechanical properties and the chosen
implant;
manipulating by a user simultaneously the soft tissue
envelope properties, the biomechanical properties and the chosen
implant on the interactive view by using buttons on the
interactive view;
recalculating the solution based on the functional goal and
the user's manipulations of the soft tissue envelope properties and
the biomechanical properties until a chosen solution is reached;
preparing the joint to receive the chosen implant; and
installing the chosen implant in the prepared joint to match
the chosen solution.
Appeal Br. 25 (Claims App'x).
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The following rejections are appealed:
Rejection I-Claims 1, 5, 8, 10-12, 15, 17-19, 22-24, 28-35, 38, 44--
48, 50, and 51 stand rejected under 35 U.S.C. §103(a) over Lavallee, 3
Murphy, 4 and Marquart. 5 Final Action 2.
Rejection 2----Claims 20 and 21 stand rejected under 35 U.S.C.
§103(a) over Lavallee, Murphy, Marquart, and Bonutti. 6 Id. at 10.
Rejection 3----Claim 36 stands rejected under 35 U.S.C. §103(a) over
Lavallee, Murphy, Marquart, and Tsougarakis. 7 Id. at 11.
Rejection 4-----Claims 39, 42, and 43 stand rejected under 35 U.S.C.
§103(a) over Lavallee, Murphy, Marquart, andPearl. 8 Id. at 12.
Rejection 5----Claims 52 and 55 stand rejected under 35 U.S.C.
§103(a) over Lavallee, Murphy, Marquart, and Matsen. 9 Id. at 13.
Rejection 6-----Claims 37, 60, and 61 stand rejected under 35 U.S.C.
§103(a) over Lavallee, Murphy, Marquart, and Delp. 10 Id. at 14.
Rejection 7----Claims 62---64 stand rejected under 35 U.S.C. §103(a)
over Lavallee, Murphy, Marquart, and Petrella. 11 Id. at 15.
Rejection 8----Claims 62---64 stand rejected under 35 U.S.C. §103(a)
over Lavallee, Murphy, Marquart, and Noble. 12 Id. at 16.
3 US 2005/0101966 Al (pub. May 12, 2005) ("Lavallee").
4 US 2005/0234332 Al (pub. Oct. 20, 2005) ("Murphy").
5 US 2005/0267353 Al (pub. Dec. 1, 2005) ("Marquart").
6 US 6,702,821 B2 (issued Mar. 9, 2004) ("Bonutti").
7 US 2004/0147927 Al (pub. July 29, 2004) ("Tsougarakis").
8 US 2006/0129070 Al (pub. June 15, 2006) ("Pearl").
9 US 5,690,635 (issued Nov. 25, 1997) ("Matsen").
10 US 5,682,886 (issued Nov. 4, 1997) ("Delp").
11 US 2003/0184577 Al (pub. Oct. 2, 2003) ("Petrella").
12 US 2004/0030245 Al (pub. Feb. 12, 2004) ("Noble").
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Rejection 9-----Claims 65----67 stand rejected under 35 U.S.C. §103(a)
over Lavallee, Murphy, Marquart, and Eckhoff. 13 Id. at 17.
FINDINGS OF FACT
We adopt the Examiner's findings of fact as set forth in the Final
Action and Answer. Final Action 2-20; Answer 2-13. We note the
following findings of fact (FF) to highlight certain evidence.
FF 1. Lavallee discloses "a system for determining the ideal
theoretical position of a knee prosthesis." Lavallee Abstract, i-f 83; see
also Final Action 2-20 and Answer 2-8, 10-13 (discussing Lavallee).
FF2. Lavallee discloses "automatically determining an ideal
theoretical position of all the implants to be attached on each bone,
taking into account all the essential criteria and then letting the
surgeon modify the parameters with respect to the so-called ideal
reference, just before performing the surgical acts enabling placing the
implants." Lavallee i-f 16; see also Final Action 2-20 and Answer 2-
8, 10-13 (discussing Lavallee).
FF3. Lavallee discloses "determining the ideal theoretical
position of a knee prosthesis," as a prelude for surgically providing
such a prosthesis, including determining the shape, position, and
orientation of the tibia, ankle joint, femur, and hip joint, with respect
to one another, using "a tridimensional positioning system," including
a palpation device, echographic device, and/or radiographic device, as
well as "means for adjusting a preestablished model of the leg bones
13 US 5,681,354 (issued Oct. 28, 1997) ("Eckhoff').
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using the collected position information." Lavallee i-fi-f 18--40; see also
Final Action 2-20 and Answer 2-8, 10-13 (discussing Lavallee).
FF4. Lavallee discloses a knee joint
model also includes a modeling of the pos1t10ns of the
attachments of the ligaments of the knee joint, this modeling
being adapted to the patient at the same time as the model of the
bone surface, and said model also includes the values of the
maximum elongations of each ligament, experimentally
determined by having the still non-operated patient's leg move
to locate the displacement limits linked to existing ligaments.
Lavallee i141; see also Final Action 2-20 and Answer 2-8, 10-13
(discussing Lavallee).
FF5. Lavallee discloses:
[T]he system further includes means for:
simulating on the image of the femur-tibia assembly the
positioning of the prostheses linked together for different flexion
positions, and the position of the knee ligaments;
deducing therefrom the motion limits that the leg provided
with the prosthesis will have with the existing ligaments; and
taking this information into account to modify the
theoretical ideal position of the knee prosthesis, and/ or to suggest
an intervention on the ligaments.
Lavallee i-fi-142--45; see also Final Action 2-20 and Answer 2-8, 10-
13 (discussing Lavallee).
FF6. Lavallee discloses:
According to an embodiment of the present invention, said
palpation device has a ball-shaped end and the locating by the
palpation device is performed dynamically as said ball is
displaced against the portion to be analyzed, the tridimensional
positioning system being designed to determine the
instantaneous positions of the ball center and a system of surface
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reconstitution from a deformable model being designed to
perform a correction corresponding to the ball radius.
Lavallee i-f 46; see also Final Action 2-20 and Answer 2-8, 10-13
(discussing Lavallee).
FF7. Lavallee discloses:
According to an embodiment of the present invention, an
image of the adjusted model is formed and this image is
displayed by assigning its various areas colors or thicknesses
characterizing the density of points found in this area by the
palpation device, which indicates the degree of accuracy of the
model of the corresponding area.
Lavallee i-f 47; see also Final Action 2-20 and Answer 2-8, 10-13
(discussing Lavallee).
FF8. Lavallee teaches "combin[ing] radiological information
and position information to construct 3D surfaces" of joint hard and
soft tissues and "displaying on a screen of [a] computer the surfaces
reconstructed in 3 dimensions," and that
it is known to define and construct models of the ligamentary
structures (also including tendons, muscles, cartilages, and
others) attached to the surfaces of the modeled bone structures.
Such models are relatively faithful approximations of the reality
which enable predicting the general behavior of the knee
structures, according to the different positions of the prostheses.
Lavallee i-fi-1 78-81; see also Final Action 2-20 and Answer 2-8, 10-
13 (discussing Lavallee).
FF9. Lavallee teaches "deform[ing] the model on the surface
points digitized on the real bone" and "the result of the deformation
may be applied to the attachment points of the ligamentary structures
on each bone of the model so that they are now known in the
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reference system associated with each bone." Lavallee i-f 81; see also
Final Action 2-20 and Answer 2-8, 10-13 (discussing Lavallee).
FFlO. Lavallee discloses:
[P]rior to the intervention, once the position marks are in place
in each bone, the surgeon or another operator exerts motions on
the tibia in all possible directions and for several knee flexions to
reach multiple extreme positions of the tibia with respect to the
femur. The operator exerts strong but reasonable forces on the
bones, to place the ligaments close to their maximum elongation.
Lavallee i-f 81; see also Final Action 2-20 and Answer 2-8, 10-13
(discussing Lavallee).
FFl 1. Lavallee discloses "models known in biomechanics may
be applied on the extension of the ligaments to assign them a non-
linear curve characterizing the elongation," and "these angular areas
may be the area of a flexion from 0 to 10°, the area of a flexion from
10 to 30°, and the area of a flexion from 70 to 120°." Lavallee i-fi-1 81,
91, 92; see also Final Action 2-20 and Answer 2-8, 10-13
(discussing Lavallee).
FF12. Lavallee discloses modeling various (tibial and femoral)
prosthesis implant sizes (with the physical model) and varying its
parameters iteratively (repeatedly), searching for the ideal position,
size and orientation; "the operator may then move each of the
parameters, preferably by means of a tactile screen (or any other
mouse equivalent), to align on values of his choice according to each
surgical technique recommendation." Lavallee i-fi-188-89; see also
Final Action 2-20 and Answer 2-8, 10-13 (discussing Lavallee).
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FF13. Lavallee discloses:
For any global position, the present invention provides
simulating relative motions of the tibia and of the femur by
rotations around contact points existing on the condyles to
simulate positions in which the ligaments are in maximum
elongation when forces approximately equivalent in intensity
and direction to the forces applied upon measurement of the
maximum elongations of the ligaments are applied. The
ligamentary balance can thus be predicted for different flexion
angles characterized by the amplitude of the motions and by the
dissymmetry of the possible motions around the neutral position.
Lavallee i-f 93; see also Final Action 2-20 and Answer 2-8, 10-13
(discussing Lavallee).
FF14. Lavallee discloses:
The surgeon can then freely determine the essential
parameters which most influence the setting of the ligamentary
balance, without having made any bone section yet. He can for
example choose to keep a perfect alignment of the hip and ankle
centers with the prosthesis center in extension, but inclining the
line perpendicular to the section planes with respect to the
mechanical axis, thus creating oblique interlines between the
prostheses. Any type of surgical technique can thus be simulated
by using the system according to the present invention.
Lavallee i-f 94; see also Final Action 2-20 and Answer 2-8, 10-13
(discussing Lavallee).
FF15. Lavallee discloses:
5. The system of claim 4, characterized in that said model also
includes a modeling of the positions of the attachments of the
ligaments of the knee joint, this modeling being adapted to the
patient at the same time as the model of the bone surface, and in
that said model also includes the values of the maximum
elongations of each ligament, experimentally determined by
having the still non-operated patient's leg move to locate the
displacement limits linked to existing ligaments.
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Application 11/290,039
6. The system of claim 5, further including means for:
simulating on the image of the femur-tibia assembly the
positioning of the prostheses linked together for different flexion
positions, and the position of the knee ligaments;
deducing therefrom the motion limits that the leg provided
with the prosthesis will have with the existing ligaments; and
taking this information into account to modify the
theoretical ideal position of the knee prosthesis, and/ or to suggest
an intervention on the ligaments.
Lavallee 9 (claims 5 and 6); see also Final Action 2-20 and Answer
2-8, 10-13 (discussing Lavallee).
FF16. Murphy discloses "[s]ystems, methods and processes for
computer-assisted soft tissue balancing, including ligament balancing,
determining surgical cuts, and positioning or placement of the
components of the prosthetic knee during TKR," with the objective
(goal) of "restoration of the knee function and patient recovery."
Murphy Abstract; see also Final Action 2, 5-19 and Answer 8-13
(discussing Murphy).
FFl 7. Murphy discloses:
The invention relates generally to computer-assisted
surgical (CAS) systems and methods of their use. More
specifically, the invention relates to instrumentation, systems,
and processes for proper positioning, and alignment of the
prosthetic knee components and proper balancing of soft tissues,
including any necessary surgical release or contraction, of the
knee ligaments, during computer-assisted total knee replacement
(TKR) surgery.
Murphy i-f 2; see also Final Action 2, 5-19 and Answer 8-13
(discussing Murphy).
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FF18. Murphy discloses:
Computer-assisted surgical systems use various imaging
and tracking devices and combine the image information with
computer algorithms to track the position of the patient's
anatomy, surgical instruments, prosthetic components, virtual
surgical constructs such as body and limb axes, and other
surgical structures and components.
Murphy i-f 3; see also Final Action 2, 5-19 and Answer 8-13
(discussing Murphy).
FF19. Murphy discloses "[d]etermining femoral component
rotation based on the surrounding soft tissue envelope [and computer-
assisted soft-tissue balancing] is attractive." Murphy i-fi-1 17, 20; see
also Final Action 2, 5-19 and Answer 8-13 (discussing Murphy).
FF20. Murphy discloses "[p ]lacing the knee under distraction in
flexion and extension in at least one of varus/valgus, AP drawer, or
rotation tests, and establishing, inflexion and extension, in a computer
memory femoral resection planes perpendicular to the long axis of the
tibia." Murphy i-f 57; see also Final Action 2, 5-19 and Answer 8-13
(discussing Murphy).
FF21. Murphy discloses:
The system according to this embodiment of the present
invention also comprises a computer comprising a processing
functionality generally adapted to receive and store information
from the tracking functionality on the position and orientation of
the femoral fiducial (112) and the tibial fiducial (114). In the
embodiment shown in FIG.1, the computer may include a
processing functionality, a memory functionality, an
input/output functionality, on a standalone or distributed basis,
via any desired standard, architecture, interface and/ or network
topology. In this embodiment, computer functionality is
connected to a monitor, on which graphics and data may be
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presented to the surgeon during surgery. The screen may
comprise a tactile interface so that the surgeon may point and
click on screen. The system may also comprise a keyboard
interface, a mouse interface, a voice recognition functionality, a
foot pedal, or any other functionality for imputing information,
wired or wireless, or any combination or modification of the
functionalities. Such functionalities allow the system's user,
such as, but not limited to, a nurse or a surgeon, to control or
direct the functionality, among other things, to capture
po si ti on/orientation information.
Items such as body parts, virtual surgical constructs,
prosthetic components, including trial components, implements,
and/or surgical instrumentation may be tracked in position and
orientation relative to body parts using fiducials. Computer
functionality can process, store, and output various forms of data
relating to position, configuration, size, orientation, and other
properties of the items. When they are introduced into the field
of tracking functionality, computer functionality can generate
and display separately or in combination with the images of the
body parts computer-generated images of body parts, virtual
surgical constructs, trial components, implements, and/or
surgical instrumentation, or other items for navigation,
positioning, assessment or other uses.
Murphy i-fi-188-89; see also Final Action 2, 5-19 and Answer 8-13
(discussing Murphy).
FF22. Murphy discloses:
The iterative cycle of the kinematic testing, comparison to the
logic matrix and ligament balancing by the surgeon continues
until reasonable convergence of the results of the kinematic
testing with the desirables kinematic properties stored in the
computer memory. This process preferably results in the
improved balance of the knee joint.
Murphy i-f 105; see also Final Action 2, 5-19 and Answer 8-13
(discussing Murphy).
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FF23. Murphy discloses "[a ]ccording to some aspects and
embodiments of the method, prosthetic component size, positioning,
and surgical cuts can be planned before any irreversible bone cuts are
made " and
'
the method is performed with the computer assistance and in the
context of computer-assisted surgical systems and methods as
described elsewhere herein. Consideration of the anatomy,
kinematics, coordinate systems, and of real and/ or virtual
surgical constructs, such as axes and planes generally involves
storage of data in computer memory and calculations optimally
performed with the aid of a computer.
Murphy i-f 111; see also Final Action 2, 5-19 and Answer 8-13
(discussing Murphy).
FF24. Marquart discloses "[a] computer-assisted knee
replacement apparatus and method comprises a total knee replacement
application for assisting, guiding, and planning a total knee
replacement procedure" and "real-time monitoring of the tibial and
femoral surface preparation procedures." Marquart Abstract; see also
Final Action 2, 5---6, 8-19 and Answer 3, 7-8, 10-13 (discussing
Marquart).
FF25. Marquart discloses:
[An] example of such an input method is the use of tracking
system 22 in combination with one or more trackable data input
devices 30. Defined with respect to the trackable input device 30
are one or more defined input areas, which can be two-
dimensional or three-dimensional. These defined input areas are
visually indicated on the trackable input device 30 so that a
surgeon can see them. For example, the input areas may be
visually defined on an object by representations of buttons,
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numbers, letters, words, slides and/ or other conventional input
devices.
Marquart i-f 21; see also Final Action 2, 5---6, 8-19 and Answer 3, 7-8,
10-13 (discussing Marquart).
FF26. Marquart discloses "FIGS. 3-17 are representative screen
images of graphical user interface pages generated and displayed by
the application program of FIG. 2." Marquart i-f 13. Marquart Figure
8, annotated, is reproduced below:
FIO. 8
Marquart Figure 8 illustrates a screen displaying image data of a knee
joint and virtual buttons (input areas annotated in red outline and
arrow) on the screen, which are provided "such that a user may
manipulate the knee center indicator 318 relative to the knee image
data 26 of the knee joint to identify and locate the knee center."
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Marquart i-f 30, Fig. 8; see also Final Action 2, 5---6, 8-19 and Answer
3, 7-8, 10-13 (discussing Marquart).
FF27. Marquart discloses:
[P]reoperative diagnostic images may be used in some
circumstances including two-dimensional and/ or three-
dimensional image data sets 26. The image data sets 36 may also
comprise a time component or dimension such that changes in
the physical structure of the subject may be displayed over
time. . . . The displayed virtual representation of the subject's
knee may then be used to perform knee implant sizing and
locating, as well as planning and guiding required femoral and/or
tibial preparation procedures for the implants.
Marquart i-f 25; see also Final Action 2, 5---6, 8-19 and Answer 3, 7-8,
10-13 (discussing Marquart).
FF28. Bonutti discloses "[a]n improved method of performing
surgery on a joint in a patient's body, such as a knee." Bonutti
Abstract; see also Final Action 10-11 and Answer 10-11 (discussing
Bonutti).
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FF29. Bonutti discloses a configuration of transducers (force
sensors) used during the method identified in the preceding finding of
fact, for example Bonutti Fig. 28 is reproduced (annotated with boxes
around relevant identifier numbers) below:
Fig.58
Fig. 58 shows "transducers 596 and 598 are utilized in combination
with the patellar transducers 930 and 932 (FIG. 58). This enables the
surgeon to determine the manner in which tension varies in the
collateral ligaments 590 and 592 (FIGS. 41and42) with variations in
force transmitted between the patella 120 (FIG. 58) and the femur
126." Bonutti 72:63-73:3, Fig. 58; see also Final Action 10-11 and
Answer 10-11 (discussing Bonutti).
FF30. Further to the preceding finding of fact, Bonutti
discloses:
Although the patellar transducers 930 and 932 are utilized
to measure force transmitted between lateral and medial portions
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of the patella 120 and the femur 126, the patellar transducers can
be utilized to stretch or move body tissue in the same manner as
the expandable devices 720, 722 and 730 (FIGS. 51 and 52). By
increasing the fluid pressure conducted to the patellar transducer
930 (FIG. 58), the patellar transducer expands to stretch fibrous
connective body tissue connected with the lateral side of the
patella 120.
Bonutti 73: 13-21; see also Final Action 10-11 and Answer 10-11
(discussing Bonutti).
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
"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). "[T]he analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ." Id. at
418. "In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
patentee controls. What matters is the objective reach of the claim. If the
claim extends to what is obvious, it is invalid under§ 103." Id. at 419.
The Examiner determined the claims would have been obvious over
the combination of Lavallee, Murphy, and Marquart, and, in some instances,
also adding Bonutti, Tsougarakis, Pearl, Matsen, Delp, Petrella, Noble, or
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Eckert, per Rejections 1-9, identified supra. The Lavallee, Murphy,
Marquart, and Bonutti disclosures and the related determinations by the
Examiner are contested by Appellants. We discern no error in the
Examiner's determinations as to what the disclosure of the prior art
combination teaches and suggests, the motivation to make the
combination(s), or the reasonable likelihood of successfully making the
combination(s). See, e.g., FF1-FF30. We address Appellants' arguments
below.
Appellants argue the Examiner has misinterpreted Lavallee in
determining the reference teaches or suggests
the [claim] limitations of: (i) calculating a solution using
determined biomechanical properties, evaluated soft tissue
envelope properties and a functional goal; (ii) manipulating by a
user simultaneously the soft tissue envelope properties, the
biomechanical properties and a chosen implant on an interactive
view; and (iii) recalculating the solution based on the functional
goal and the user's manipulations of the soft tissue envelope
properties and the biomechanical properties until a chosen
solution is reached.
Appeal Br. 11. Appellants contend Lavallee does not disclose a user
working cooperatively with a surgical navigation system in an iterative
manner to find an arthroplasty solution because Lavallee's computer does
this automatically. Id. (citing Lavallee i-f 88). Appellants contend that a user
(surgeon) reviewing the computer system's simulated implant positioning
and then making overriding changes to the parameters the computer used to
produce that simulation forecloses "further recalculation ... based on the
user's changes and the functional goal" and "[t]here is no indication of
further recalculations based on the functional goal and further user
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manipulations," even while Lavallee produces new simulations based on
new parameters input by a user. Id. at 11-12.
These arguments are not persuasive. Appellants concede Lavallee
produces a simulation of an arthroplasty implant procedure (it is based on a
navigation system's data on physiological reference points and also
associated soft tissue data), that upon display of this simulation to a user,
that user can adjust the parameters to thereby change the simulation, which
would also be displayed to the user. There is no limit to such manipulations
by the user (which take place on a touch screen) and renewed simulations by
the computer, with the goal being achieving an ideal implant placement
before beginning surgery. See, e.g., FF1-FF15. Per our review of Lavallee
in view of the Examiner's determinations, we conclude Lavallee teaches and
reasonably suggests the disputed limitations. Id.
Furthermore, the rejection is made over a combination of prior art, so
arguing a single reference fails to teach all the claim limitations is not
persuasive. "Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
isolation, but for what it fairly teaches in combination with the prior art as a
whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Moreover, Murphy, which is a part of the prior art combination, discloses
that a surgeon can perform a knee implant surgery virtually and change
aspects of the process to suit the ultimate goal and discloses that
manipulation of the soft tissue envelope in this process is an iterative process
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to achieve the ideal conditions. See, e.g., FF 16-FF23 (specifically FF21-
FF22).
Appellants argue the Examiner has misinterpreted the Marquart
reference in making the determination that its disclosure rendered obvious
that "the biomechanical properties and the chosen implant is carried out by
using buttons on the interactive view," as claimed. Appeal Br. 14.
Appellants contend that, even though Marquart teaches input devices
including input areas that are "visually defined on an object by
representations of buttons ... or other conventional input devices," these
"buttons are not displayed on an interactive view but [are] on an input device
associated with the tracking system." Id. at 15. Further, Appellants contend
Marquart does not teach that the biological properties of a joint are
manipulated by user input (using the buttons). Id. (citing Marquart i-f 21).
Appellants argue there would have been no motivation to modify Lavallee in
view of Marquart. Id at 16.
These arguments are not persuasive. Again, arguing references in
isolation is not persuasive when they are part of a combination cited in an
obviousness rejection. In re Merck, 800 F.2d at 1097. Further, the virtual
buttons shown in the figures of Marquart are not merely on an input device,
as argued by Appellants, but are images provided on a GUI screen for
manipulation of parameters by a user. See FF24-FF27. Such a disclosure
makes using virtual buttons on a touch screen to adjust a virtual image or
related parameters obvious. Moreover, Lavallee teaches its 3D knee-implant
simulations are displayed on an interactive touch screen that can also employ
any mouse-equivalent inputs. FF12. Thus, even considering Lavallee alone,
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providing virtual buttons on such a tactile display to manipulate simulation
parameters, as claimed, would have been obvious. The Examiner's citation
to Marquart illustrates examples of such buttons on a display similar to
Lavallee' s; it would have been obvious to employ such virtual inputs.
Regarding claim 17, Appellants argue it requires "using an in-situ
distracting device and flexing the joint throughout its range of motion,"
which, contrary to the Examiner's determinations, is not taught or suggested
by Murphy i-f 75, which teaches the physical spacer is locked, not flexed.
Appeal Br. 1 7.
Claim 1 7 recites "[ t ]he method of claim 1, wherein evaluation of the
soft tissue envelope properties is performed using an in-situ distracting
device and flexing the joint throughout a range of motion of the joint."
Appeal Br. 26-27. The Examiner determined Murphy i-fi-157 and 75 teach or
suggest this. Murphy i-f 57 discloses, within the context of its greater
disclosure, "[p ]lacing the knee under distraction in flexion and extension ...
and establishing, inflexion and extension, in a computer memory femoral
resection planes perpendicular to the long axis of the tibia." FF20. Murphy
i-f 7 5 does disclose distracting the knee "in the course of kinematic testing"
using a physical spacer or tensor, where "[t]he physical spacer is typically
adapted to be locked or stabilized in any desired position." We conclude the
Examiner's determination is correct; Murphy teaches and suggests
evaluating soft tissue envelope properties using an in-situ distracting device
and flexing the joint throughout a range of motion of the joint, whether
simultaneously or not. FF 16-FF23.
Similarly, Lavallee discloses:
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modeling of the positions of the attachments of the ligaments of
the knee joint, this modeling being adapted to the patient at the
same time as the model of the bone surface, and said model also
includes the values of the maximum elongations of each
ligament, experimentally determined by having the still non-
operated patient's leg move to locate the displacement limits
linked to existing ligaments.
FF4. Lavallee discloses, in the context of its disclosed simulated prosthesis
implantation procedure and performing the actual procedure, defining an
ideal prosthetic positioning from flexion to extension (of tibia relative to
femur) from 0° to 120°. FFl 1, FF13, FF15. In view of the above,
Appellants' arguments are not persuasive.
Regarding claim 21, Appellants argue Bonutti and Murphy fail to
teach that load distribution is assessed with sensing elements embedded in
the distracting device because Murphy relies on a physical tensor and
Bonutti relies on leg weight. Appeal Br. 18.
Claim 21 recites "the load distribution is assessed with sensing
elements embedded in the distracting device." The Examiner determined
that Bonutti's Figure 58 and the related disclosure (cols. 72-73) taught that
patellar transducers are utilized in knee surgery both as force sensors and as
soft tissue expanders. We find Bonutti discloses transducers/sensors that are
also distraction devices. FF28-FF30. Bonutti discloses measuring force
transmitted between bones of the knee joint while using these distraction
tools. Id. Therefore, we conclude, as determined by the Examiner, Bonutti
teaches and suggests the disputed claim limitation.
Regarding independent claims 60 and 62, Appellants identify their
similarities to claim 1 and renew their arguments thereover in view of
Lavallee, Murphy, and Marquart. See Discussion supra. Appeal Br. 19.
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Further, Appellants contend neither Delp nor Petrella nor Noble "fill in the
deficiencies of Lavallee, Murphy, and Marquart." Id. at 20-24.
Because Appellants do not contest the Examiner's determinations as
to Delp, Petrella, and Noble, for the reasons discussed above regarding the
rejection of claim 1, we are also not persuaded here.
Because we find the preponderance of the evidence supports the
Examiner's case for the obviousness of the claims, and we are not persuaded
by Appellants' arguments, we affirm the rejections for the reasons set forth
above.
SUMMARY
The obviousness rejections are each 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)(l )(iv).
AFFIRMED
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