Ex Parte Park et al

Patent Trials and Appeals Board

Jun 25, 2019

11946002 - (D) (P.T.A.B. Jun. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/946,002 11/27/2007 Ilwhan Park
24030 7590 06/27/2019
POLSINELLI PC
900 West 48th Place
Suite 900
KANSAS CITY, MO 64112-1895
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.
065618-423989 8407
EXAMINER
COOK, CHRISTOPHER L
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
06/27/2019 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):
uspt@polsinelli.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IL WHAN PARK and STEPHEN M. HOWELL 1
Appeal2017-006922
Application 11/946,002
Technology Center 3700
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
TA WEN CHANG, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of creating a customized arthroplasty jig, which have been rejected
as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Appellants identify the Real Party in Interest as Howmedica Osteonics
Corporation. (Br. 3.)
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Application 11/946,002
STATEMENT OF THE CASE
The human knee generally has the structure shown below:
./
cq
4a~~::,?i""~ """~~z-f-TP
4 4,6
- -MEO/AL LATERAL
(Hollister2 Fig. 3.) The figure above is a "schematic anterior view of the left
human knee." (Id. at 4:60-63.) As shown in the figure, "[t]he femur bone 1
has a medial condyle 2a and a lateral condyle 2b at its distal end. . . . [T]he
tibia bone 3 terminates at its proximal end with a tibular plateau 4 having a
medial and lateral concavity 4a and 4b to seat within the two medial and
lateral condyles 2a and 2b, respectively." (Id. at 5:26-34.)
"The human knee joint is one of the most stressed joints of the human
body," and a large number of patients undergo surgery for knee replacement
each year. (Id. at 1:10-11, 21-23.) In surgical reconstruction or
replacement of a joint (i.e., arthroplasty),
one or more arthroplasty jigs may be employed to help
prepare the damaged region for an implant, and to increase
the likelihood that the implant will be correctly positioned
2 Hollister, U.S. Patent No. 5,133,758, issued July 28, 1992 ("Hollister").
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Application 11/946,002
and aligned at a target site in the damaged region. The
arthroplasty jigs may be used, for example, to aid in the
correct placement of finishing instruments, such as
cutting, drilling, reaming, and resurfacing instruments.
(Park3 ,i 63.)
Medical imaging systems such as magnetic resonance imaging (MRI)
or computed tomography (CT) systems are used to generate 2D images of
joint regions of patients, which are then converted via a computer program
into 3D bone and/or bone-cartilage models for use in creating customized
arthroplasty jigs. (Spec. ,i 3.) The 2D images may include coronal, axial,
and sagittal images, which are images of particular planes or views of the
human body as illustrated below:
The image above depicts the coronal, sagittal, and axial planes of the human
body. Keith Bridwell, Anatomical Planes of the Body, SPINEUNIVERSE,
3 Park et al., US 2007/0226986 Al, published Oct. 4, 2007 ("Park").
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Application 11/946,002
https://www.spineuniverse.com/anatomy/anatomical-planes-body (last
visited June 25, 2019).4
According to the Specification, MRI is preferred to CT in generating
these images because MRI provides greater resolution and involves no
radiation. (Spec. ,-J 5.) Further according to the Specification, however, to
obtain images having adequate resolution, conventional MRI requires
patients to be still and maintain a position for long periods of time and/or
may need to be repeated for a patient because of movement. (Id. ,-i,-i 6-7.)
The Specification states that, therefore, "[t]here is a need in the art for a MRI
system and method that improves the likelihood a MRI procedure will result
in MRI image slices that are useable for the generation of 3D bone models
used in the generation of customized arthroplasty jigs." (Id. ,-i 8.)
Claims 29-38, 40, 68, 70-74, and 76-78 are on appeal. 5 Claim 29 is
illustrative and reproduced below:
29. A method of creating a customized arthroplasty jig, the
method comprising:
obtaining two-dimensional MRI images of a knee joint
area to undergo arthroplasty, the two-dimensional MRI images
including coronal, axial, and sagittal MRI images;
identifying, in at least one of the coronal MRI images, a
most distal point on a femur medial condyle and a most distal
point on a femur lateral condyle;
connecting the distal points with a first tangent line;
identifying, in at least one of the axial MRI images, a most
posterior point on the femur medial condyle and a most posterior
point on the femur lateral condyle;
4 The same or a similar image was reproduced in black and white in the
Answer. (Ans. 4.)
5 Claims 44-67 have been cancelled. (Br. 7.)
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Application 11/946,002
connecting the posterior points with a second tangent line;
subsequent to obtaining the two-dimensional MRI images,
electronically reorienting the sagittal MRI images to be
perpendicular to the first tangent line intersecting the distal
points and the second tangent intersecting the posterior points;
using a computer to generate a three-dimensional bone
image of at least a portion of a bone of the patient's joint area
from the obtained two-dimensional MRI images;
using the three-dimensional bone image to generate data
pertaining to the customized arthroplasty jig;
providing the data to at least one manufacturing device;
and
employing the data to cause the at least one manufacturing
device to create the arthroplasty jig.
(Br. i (Claims App'x).)
The Examiner rejects claims 29-32, 68, 70-74, and 76-78 under
pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Park, Habets,6
Graessner,7 Calvo,8 and either Murphy9 or Hollister. (Non-Final Act. 10
4-5.)
6 Habets et al., US 2008/0232661 Al, published Sept. 25, 2008 ("Habets").
7 Graessner, US 2005/0197562 Al, published Sept. 8, 2005.
8 E. Calvo et al., High-Resolution MRI Detects Cartilage Swelling at the
Early Stages of Experimental Osteoarthritis, 9 OSTEOARTHRITIS AND
CARTILAGE 463 (2001) ("Graessner").
9 Murphy et al., US 2008/0208081 Al, published Aug. 28, 2008
("Murphy").
10 May 18, 2016 Office Action ("Non-Final Act.").
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The Examiner rejects claims 33-38 under pre-AIA 35 U.S.C. § 103(a)
as being unpatentable over Park, Habets, Graessner, Calvo, either Murphy or
Hollister, Delp, 11 and Mostafavi. 12 (Non-Final Act. 8-9.)
The Examiner rejects claim 40 under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Park, Habets, Graessner, Calvo, either Murphy or
Hollister, and Tsougarakis. 13 (Non-Final Act. 11.)
DISCUSSION
Issue
The same issues are dispositive for all the rejections; we therefore
discuss them together. With respect to independent claims 29 and 68, the
Examiner finds that Park teaches "obtaining a plurality of 2D MRI slices and
converting the 2D slices into a 3D anatomical computer model of the knee
joint" before "appropriately sized knee implants ... are selected ... and/or
sent to an arthroplasty jig manufacture[r] for production of one or more
customized arthroplasty jigs," as generally recited in the claims. (Non-Final
Act. 5.) The Examiner finds that Park teaches identifying landmarks such as
medial and lateral epicondyles of the distal region of the femur as required
by the claims (the "identifying" and "connecting" steps of claim 29
correspond to the landmarks described in the cited prior art). (Id.)
The Examiner finds that Park "does not expressly disclose using the
identified landmarks to reorient other slices in a particular orientation ( e.g.
sagittal) as claimed." (Id.) However, the Examiner finds that Habets, which
11 Delp et al., U.S. Patent No. 5,871,018, issued Feb. 16, 1999 ("Delp").
12 Mostafavi et al., US 2005/0201509 Al, published Sept. 15, 2005
("Mostafavi").
13 Tsougarakis et al., U.S. Patent No. 7,634,119 B2, issued Dec. 15, 2009
("Tsougarakis").
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relates to "a similar field of endeavor with respect to MRI volumetric
renderings of the knee joint," teaches anatomical landmarks being "defined
in an initial view ... and ... used to determine the new geometry ... of the
new view ... in a subsequent step." (Id. at 5-6.) The Examiner also finds
that Habets teaches using tangent lines to align other planes similar to the
"connecting" and "reorienting" steps of claim 29. (Id.)
The Examiner finds that Habets "does not expressly disclose drawing
a line on a coronal slice at a most distal point on a femur medial and lateral
condyles," as required by claim 29, but also finds that "such landmark
identification is well established in the prior art." (Id.)
For example, the Examiner finds that Graessner teaches automatically
identifying the sagittal plane using a line connecting both condyles in the
knee while Calvo teaches sagittal slices of the knee being "perpendicular to
a line tangent to the posterior border of the femoral condyles." (Id. at 6-7.)
With respect to the limitation of identifying certain anatomical landmarks in
a coronal image and connecting the landmarks with a tangent line, the
Examiner finds that Murphy teaches identifying anatomical landmarks in
coronal images while Hollister teaches drawing lines on a coronal slice to
identify other planes. (Id. at 7.)
The Examiner concludes that at the time of the invention it would
have been obvious to a skilled artisan to modify Park's method of creating a
customized arthroplasty jig by incorporating Habets' pre-operative planning
process to identify conventional anatomical landmarks, such as points on the
femoral condyles, and by using tangent lines connecting such landmarks to
"align ( e.g. reorient) other [MRI] slices as described in Graessner, Calvo,
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and Murphy/Hollister in order to enhance the 3D model of the knee used to
create an appropriate jig." (Id. at 7-8 (italicization omitted).)
With respect to claims 7 4 and 78, which the Examiner finds to
"utilize[] geometric attributes of identified anatomical landmarks" in a
method to "electronically orient acquired MR image data as described [in
claim 68]," the Examiner finds that "[t]he specific geometric steps [recited
in the claims] are considered to be an obvious design choice in the absence
of showing any criticality or unexpected result." (Id. at 8.)
Appellants contend that the cited references do not suggest
"identifying distal points on femur condyles, connecting the distal points
with a tangent line, and reorienting the sagittal MRI images based on the
tangent line," as required by claim 29. (Br. 7.) Similarly, Appellants
contend that the cited references do not suggest "identifying a pair of boney
landmarks in a coronal image, connecting the pair of points with a tangent
line, and reorienting the sagittal MRI images based on the tangent line," as
required by claim 68. (Id. at 9.) Finally, Appellants contend that, as to
claims 74 and 78, the cited references do not teach "a step that verifies the
proper orientation of the electronically reoriented sagittal MRI images," as
required by these claims. (Id. at 9-12.)
Appellants' only argument with respect to dependent claims 30-38,
40, 70-73, 76, and 77 is that they are patentable for at least the same reasons
that independent claims 29 and 68 are patentable. We therefore treat claims
29 and 68 as representative of those claims and limit our analysis to claims
29, 68, 74, and 78. The issues with respect to the three rejections on appeal
are as follows:
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Application 11/946,002
1. Whether a preponderance of the evidence of record supports the
Examiner's finding that the cited references suggest a method of creating a
customized arthroplasty jig comprising identifying in a coronal MRI image
the most distal points on femur medial and lateral condyles, connecting the
distal points with a tangent line, and electronically reorienting the sagittal
MRI images based on the tangent line, as required by claim 29;
2. Whether a preponderance of the evidence of record supports the
Examiner's finding that the cited references suggest a method of modeling a
patient's joint area, comprising "identifying a ... pair of boney landmarks in
the coronal MRI images; connecting the ... landmarks with a ... tangent
line; [ and] electronically reorienting the sagittal MRI images" based on the
tangent line, as required by claim 68; and
3. Whether a preponderance of evidence of record supports the
Examiner's finding that the cited references suggest verifying that "the
electronically reoriented sagittal MRI images are properly oriented" in the
manner recited in claims 74 and 78.
Findings of Fact
1. Park teaches a method of making customized arthroplasty jigs
(Park ,i,i 11, 12, 16, 67-68, 72, 83-85, 89-90, Figs. 3, 11).
2. Park teaches preoperative planning in a total knee arthroplasty
(TKA) procedure "to help determine where to position an implant and how
to align the implant," including making these determination based on knee
region landmarks viewed in a two-dimensional image of the target site. (Id.
,i,i 7, 68-69.)
3. Park teaches using a computer to convert the two-dimensional
MRI images into three-dimensional anatomical computer models of the knee
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joint, which includes among other things the cortical bone of the femur and
the tibia. (Id. ,i,i 68-69, 73-74, 94, Figs. 3-5.)
4. Park teaches sending "[t]he data gathered from preoperative
planning ... to an arthroplasty jig manufacturer for production of one or
more customized arthroplasty jigs." (Id. ,i,i 72, 78-80, 84.)
5. Habets teaches tools that provide volume rendering or
visualization from, e.g., MRI images. (Habets ,i 2.)
6. Habets teaches that visualization tools allow users to view and
perform measurements in the data, and that
measuring applications often involve positioning and
editing of anatomical landmarks or other supporting
graphics like points (for example: the center of a joint or
bone), lines (for example: tangents to, or edges from, or
axes of anatomical structures), contours (for example:
delineating certain anatomical parts), planes (for example:
though the axis and neck of the femoral bone) or balls ( for
example: modeling of joints).
(Id. iJ 4.)
7. Habets teaches an embodiment of a visualization tool wherein
each clinical task will define an initial view ( or views).
Selection clicks or anatomical landmarks or supporting
graphics (hereinafter, referred to as points of interest
(POI)) that were defined in the respective view[] will
determine the new geometry ( or geometries) of the new
view ( or views) in a subsequent step. In the new view ( or
views), new points of interest can again be defined (via a
selection click), wherein the process is repeated as
necessary according to the workflow of a given clinical
task.
(Id. iJ 24.)
8. Habets teaches a "workflow example of an orthopedic
measurement for determining the internal rotation of the femoral bone,"
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Application 11/946,002
which "quantifies the angle between the femoral neck and the femoral
condyles axis." (Id. ,i 29, Figs. 3-7.)
9. In Habets' example, "[t]he initial view 50 comprises two
transversal slices 52 and 54, which are aligned with the original image
stack" and shows "the proximal and distal part of the femur," as shown in
Habets' Figure 3 reproduced below:
FIG. 3
Habets' Figure 3 shows the initial views 52 and 54 with arrows pointing to
the center of the femoral bone. (Id. ,i,i 30-31.)
10. Habets teaches that, responsive to the user's click-style
selection of the proximal and distal center of the femoral axis in the initial
views (id. ,i 31 ), the visualization tool provides "a thumbnail slab depth
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Application 11/946,002
selector 60 aligned with the femur axis," as shown in Habets' Figure 4
reproduced below:
FIG. 4
Figure 4 of Habets shows "a thumbnail slab depth selector 60 aligned with
the femur axis." (Id.)
11. In Habets' example, the user then selects a thumbnail at knee
level showing both condyles (i.e., the thumbnail to which the arrow points in
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Figure 4 above) and "draw[s] a line touching the posterior aspects of both
femoral condyles," as shown in Habets' Figure 5 reproduced below:
FIG. 5
70
/·;/'
Habets' Figure 5 illustrates "a perpendicular slab selected from the
thumbnail selector portion of FIG. 4 at the knee level," with "a line touching
the posterior aspects of both femoral condyles." (Id. ,i 32.) Habets teaches
that this line
corresponds to drawing the condylar tangent plane,
wherein the tangent points are indicated by arrows
proximate opposite ends of the line. In other words, the
line corresponds to a tangent line which is actually a plane
perpendicular to the femur anatomical axis.
(Id.; see also id. ,i 41 ( explaining that a tangent line drawn on a slab is used
as a plane perpendicular to the slab).)
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12. Habets further teaches selecting a thumbnail from a
perpendicular slab at the hip level and drawing a line through the femoral
neck, as shown in Figure 6, reproduced below:
82
j
FIG. 6
84
j
"The left image 82 of FIG. 6 comprises a slab aligned with the femoral axis
as selected in the thumbnail depth selector showing the femoral neckline
plane" where the arrows within image 82 "show the selected line start and
end points of the femoral neckline plane." (Id. ,i 33.) "The right image 84
of FIG. 6 comprises a slice based on the plane defined in the left image 82
showing the femoral neckline." (Id.)
13. Finally, Habets teaches setting up "an image perpendicular to
the femoral axis" wherein "[t]he internal rotation of the femoral bone is
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Application 11/946,002
defined as the angle between the two lines in this perpendicular plane," as
illustrated in Figure 7, reproduced below:
90
/
92 94
J
FIG. 7
"The left image 92 [ of Ha bets' Figure 7] comprises an image perpendicular
to the femoral axis showing a slice at knee level with the projected axes,"
wherein "[t]he internal rotation of the femoral bone is defined as the angle
between the two lines in this perpendicular plane." (Id. ,i 34.) "The right
image 94 comprises a drawing explaining the measurement." (Id.) Habets
further teaches that a similar view could have been obtained by "merging the
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slab containing the condylar tangent and the slab containing the femoral
neckline," i.e., where "both the condyle tangent and the femoral neckline are
projected on a plane perpendicular to the femoral axis." (Id.)
14. Graessner teaches a method for automatically determining the
sagittal plane for the examination regions of an object using a magnetic
resonance apparatus, based on coronal localizer image exposures of the
examining region. ( Graessner ,i,i 2, 6-7, Abstract.)
15. Graessner teaches that in its invention "[t]he image acquisition
is processed and evaluated by the image-processing unit of the magnetic
resonance apparatus using an appropriate assessment algorithm to determine
the middle sagittal image position and tilting ... the sagittal plane with
respect to the apparatus coordinate system." (Id. ,i 8.) Graessner teaches
that "any assessment algorithm for image evaluation of the localizer image
acquisition can be used as long as it is appropriate for determining the
sagittal position and the resultant sagittal plane." (Id. ,i 9.)
16. Graessner teaches that "[ a ]dditionally or alternatively it is
possible to make the plane determination based on a muster recognition
analysis for the ascertainment of anatomical landmarks in the images, or in
one or multiple specified image regions." (Id.)
17. Graessner teaches that sagittal plane determination may be
important in, e.g., knee examination. Graessner teaches that
[i]n one such case the automatic sagittal plane
determination corresponding to the invention is applied for
ascertainment of the rear condyles of the thighbone
(femur) as anatomical landmarks. For determining the
sagittal plane a line is established connecting both
"condyles", for which the perpendicular sections
determining the position of the sagittal plane are
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calculated. Then subsequently the plane determination
upon the basis of template pattern recognition and
anatomical landmarks, whereby another parameter setting
in regards to the localizer image acquisition, is selected.
(Id. ,i 13; see also id. at claims 8, 9.)
18. Calvo investigates "[t]he progressive early changes in cartilage
and subchondral bone in an experimental model of osteoarthritis (OA) ...
with high-resolution magnetic resonance imaging (MRI) and
microradiography." (Calvo Summary.)
19. Calvo teaches an image acquisition protocol in which
[a] first set of coronal slices was used to establish the
position of the knee in the coil. The second set of axial
slices through the femoral condyles allowed adjustments
to be made to position coronal and sagittal slices. Coronal
images to assess OA lesions were easily localized parallel
to the posterior femoral condyles. To obtain reproducible
sections, the sagittal slices were always displayed on the
specific axial slice where the arch of the femoral notch
described a perfect semi-circumference ('roman arch
view') and they were perpendicular to a line tangent to the
posterior border of the femoral condyles.
(Id. at 464, right column ( citation and footnote omitted); see also id. at Fig. 1
( describing obtaining sagittal slices perpendicular to a line tangent to the
posterior femoral condyles ). )
20. Murphy teaches a system and method for determining tibial
rotation. (Murphy Abstract.)
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21. Figure 22 of Murphy is reproduced below:
i
i, ,·
I
. I
I
'
FJG. 22
Murphy's Figure 22 is a schematic in the coronal plane that depicts the
"relationship of the weight bearing axis (WBA) 50 to a left human femur 12
and tibia 10 in normal stance." (Id. ,-i 79.) Murphy teaches that the joint line
58 is "a plane perpendicular to weight bearing axis 50 at a point
approximating the bearing surface between femur 12 and tibia 10." (Id.)
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22. Hollister teaches a total knee endoprosthesis with a fixed
flexion-extension axis throughout all degrees of flexion and extension of the
knee. (Hollister Abstract.)
23. Hollister's Figure 9 is reproduced below:
/
--
21 6
\ l
TP
Hollister's Figure 9 depicts "a front view of the left femoral component 20
[ of a total knee prosthesis] affixed to the femur 1." (Id. at 8: 11-12.)
Hollister teaches that "[t]he distal most surface of the medial and lateral
condyle portions 21 and 22 are in the transverse (horizontal) plane TP." (Id.
at 8:12-14; see also id. at Fig. 3 (reproduced at page 2 above and showing
TP as tangent line connecting distal most points of medial and lateral
condyles).)
Analysis
Claims 29-38, 40, 68, 70-73, 76, and 77
Unless otherwise noted, we adopt the Examiner's findings of fact and
reasoning regarding the Examiner's rejection of claims 29 and 68 (Non-
Final Act. 4-8; Ans. 3-8; FF 1-23) and agree that claims 29 and 68 are
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obvious over at least the combination of Park, Habets, Graessner, Calvo, and
Hollister. 14 Only those arguments timely made by Appellants in the Appeal
Brief (no Reply Brief was submitted) have been considered; arguments not
so presented in the Brief are waived. See 37 C.F.R. § 41.37(c)(l)(iv)
(2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI
2010) (informative) ("Any bases for asserting error, whether factual or legal,
that are not raised in the principal brief are waived."). We address
Appellants' arguments below.
Appellants contend that claim 29 is patentable because the
combination of prior art does not suggest "identifying distal points on the
condyles in at least one of the coronal MRI images, connecting the distal
points with a tangent line, and electronically reorienting the sagittal MRI
images based on the tangent lines." (Br. 7 ( emphasis omitted).) More
specifically, Appellants contend that the Examiner relies on Hollister for
disclosing the limitations cited above and further contend that, although
"Hollister recites a 'transverse plane TP,' ... there is no discussion of what
the transverse plane is, how it is defined, or how it is used to reorient sagittal
MRI images." (Id. at 7-8.)
Appellants first contend that Hollister "does not illustrate how the
transverse plane TP is defined on a knee joint," i.e., does not define the
transverse plane using the tangent connecting the distal most points of the
femur medial and lateral condyles. (Br. 8.) We are not persuaded. Hollister
14 Because the Examiner's rejection is based on a combination of Park,
Habets, Graessner, Calvo with either Murphy or Hollister, and because we
agree that claims 29 and 68 are obvious over Park, Habets, Graessner,
Calvo, and Hollister, we need not decide whether the claims are also obvious
over Park, Habets, Graessner, Calvo, and Murphy.
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teaches that "[t]he distal most surface of the medial and lateral condyle
portions ... are in the transverse (horizontal) plane TP." (FF 23.) Thus, we
find that Hollister suggests that the transverse plane is defined by a tangent
connecting the distal most points of the femur medial and lateral condyles.
Appellants next argue that "Hollister does not describe identifying
distal points on lateral and medial femoral condyles in at least one coronal
MRI image because Hollister does not describe any imaging modalities ( e.g.,
X-ray, CT, MRI)." (Br. 8-9.) Appellants contend that, "[t]herefore, even if
Hollister describes the [ claimed] 'first tangent line' with reference to the
transverse plane TP, Hollister does not describe reorienting sagittal MRI
images because Hollister does not describe MRI images." (Id.)
We are not persuaded. "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).
In this case, Hollister teaches that, in a front or anterior view (i.e., a coronal
view), the tangent connecting the distal most points of the femur medial and
lateral condyles defines a transverse plane. (FF23.) As Appellants concede
(Br. 8), the transverse plane is perpendicular to the sagittal and coronal
planes. Graessner and Calvo both teach orienting the sagittal plane in an
imaging application using a tangent representing a plane perpendicular to the
sagittal plane. (FFl 7, FF19.) We agree with the Examiner that, in view of
the combination of cited references, a skilled artisan would have had reason
to use the tangent taught in Hollister as defining the transverse plane (i.e., a
plane perpendicular to the sagittal plane) in a coronal view to orient the
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sagittal plane in MRI imaging, as taught by Calvo and Graessner, for
purposes of creating 3D computer models of the knee joint for producing
customized arthroplasty jigs, as taught by Parker.
Appellants argue that "claim 68 is patentable for at least the reasons
discussed [with respect to claim 29.]" (Br. 9.) We are not persuaded for the
same reasons discussed above.
Accordingly, we affirm the Examiner's rejection of claims 29 and 68.
Claims 30-32, 70-73, 76, and 78, which are not separately argued, fall with
claims 29 and 68. 37 C.F.R. § 41.37(c)(l)(iv). Appellants make no
additional arguments with respect to claims 33-38, which were rejected over
Park, Habets, Graessner, Calvo, either Murphy or Hollister, Delp, and
Mostafavi, or claim 40, which was rejected over Park, Habets, Graessner,
Calvo, either Murphy or Hollister, and Tsougarakis. We, therefore, affirm
these rejections for the same reasons.
Claims 74 and 78
On balance, we agree with Appellants that the Examiner has not
established a prima facie case that claims 7 4 and 78 are obvious over the
cited prior art combination.
Claims 7 4 and 78 both depend indirectly from claim 68 but further
require a step (see claim 71, from which claims 7 4 and 78 also depend) of
"verifying the electronically reoriented sagittal MRI images are properly
oriented" by looking at the offset distance between the most distal points of
the medial and lateral condyles and the offset distance between the most
posterior points of the condyles. (Br. iii-v (Claims App'x).) Claim 74 then
specifies that the verification process further comprises computing the
arctangent of a fraction defined as the offset distance of the most distal
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points of the medial and lateral condyles divided by the perpendicular
distance between two sagittal MRI images, 15 wherein "the electronically
reoriented sagittal MRI images are properly oriented when the [arctangent]
is greater than or equal to minus 5 degrees and less than or equal to five
degrees." (Id. at iii-iv (Claims App'x).) Similarly, claim 78 specifies that
the verification process further comprises computing the arctangent of a
fraction defined as the offset distance of the most posterior points of the
medial and lateral condyles on the electronically reoriented sagittal MRI
images depicting, respectively, the largest cross sections of the medial and
lateral condyles, divided by the perpendicular distance between the two
sagittal MRI images, wherein "the electronically reoriented sagittal MRI
images are properly oriented when the [arctangent] is greater than or equal
to minus 5 degrees and less than or equal to five degrees." (Id. at iii-v
(Claims App'x).)
The Examiner does not dispute Appellants' contention that the cited
references do not explicitly describe a step of "verif[ying] the proper
orientation of the electronically reoriented sagittal MRI images" or teach
how to "determine the suitability of the reoriented sagittal images." (Br. 10-
12; Ans. 8-9.) However, the Examiner asserts conclusorily with regard to
claim 71, from which claims 7 4 and 78 depend, that "the adjusted sagittal
planes would take into account an 'offset' distance depending on the
15 We note that claim 74 depends from claim 73, which does not depend
from claim 72, the claim that defines the particular sagittal MRI images on
which the distal most points of the medial and lateral condyles should be
determined. Accordingly, the terms "the first sagittal MRI image" and "the
second sagittal MRI image" in claim 73, from which claim 74 depends,
appear to lack antecedent basis.
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established knee position within the coil as described above."16 (Non-Final
Act. 8.) The Examiner also asserts with respect to claims 74 and 78 that
(Id.)
that
the system and method to electronically orient acquired
MR image data as described above utilizes geometric
attributes of identified anatomical landmarks. The
specific geometric steps are considered to be an obvious
design choice in the absence of showing any criticality or
unexpected result. That is to say, the system and method
described above is considered to be a functional equivalent
to reproducibly acquire the appropriate MR image data.
In response to Appellants' Appeal Brief, the Examiner further asserts
the modified, reoriented sagittal plane would be set to be
perpendicular ( e.g. 90 degrees) to the tangent lines ....
Appellant's verification step which provides an angular
tolerance to the reorientation appears to be nothing more
than the routine optimization or workable ranges to the
geometric relationships described by the prior art.
Furthermore, Examiner notes that Appellant has failed to
show any criticality or unexpected result from the claimed
tolerance.
(Ans. 8-9.)
We are not persuaded. "The Patent and Trademark Office (PTO)
must consider all claim limitations when determining patentability of an
invention over the prior art." In re Lowry, 32 F.3d 1579, 1582 (Fed. Cir.
1994) (citation omitted). In this case, the Examiner has not cited any prior
art as disclosing a verification process or the particular verification process
steps recited in claims 74 and 78.
16 Calvo teaches using a "set of coronal slices ... to establish the position of
the knee in the coil." (FF 19.) Thus, to the best of our understanding, the
Examiner is referring to Calvo in the quoted statement.
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We acknowledge that the obviousness analysis "can take account of
the inferences and creative steps that a person of ordinary skill in the art
would employ," KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007),
and that the Examiner asserts that the verification steps at issue are either
obvious design choices or subject to routine optimization. However,
"rejections on obviousness grounds cannot be sustained by mere conclusory
statements; instead, there must be some articulated reasoning with some
rational underpinning to support the legal conclusion of obviousness." Id.
(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). The Examiner has
not sufficiently explained, for example, why the angle recited in claims 7 4
and 78 (i.e., the arctangent of the fraction defined by the offset distances
with respect to the most distal and/or posterior points of the medial and
lateral condyles divided by the perpendicular distance between two
particular sagittal MRI images) was known to be a result effective variable
at the time of Appellants' invention. See In re Antonie, 559 F .2d 618, 620
(CCPA 1977) ( optimizing a parameter not recognized to be a result effective
variable would not have been obvious).
Accordingly, we reverse the Examiner's rejection of claims 74 and 78.
SUMMARY
For the reasons above, we affirm the Examiner's decision rejecting
claims 29-38, 40, 68, 70-73, 76, and 77. We reverse the Examiner's
decision rejection claims 74 and 78.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a).
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AFFIRMED-IN-PART
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