Ex Parte Paradis et al

Patent Trial and Appeal Board

Jul 25, 2016

11339499 (P.T.A.B. Jul. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111339,499 01/26/2006 Francois Paradis
93758 7590 07/26/2016
NORTON ROSE FULBRIGHT CANADA LLP (Zimmer Cas)
1 Place Ville Marie
Suite 2500
Montreal, QC H3B IRI
CANADA
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.
15228-41US PTN/df 7756
EXAMINER
BRUTUS, JOEL F
ART UNIT PAPER NUMBER
3777
MAILDATE DELIVERY MODE
07/26/2016 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 FRANCOIS PARADIS,
HERBERT ANDRE JANSEN, BRUNO FALARDEAU, and
LOUIS-PHILIPPE AMIOT 1
Appeal2014-008049
Application 11/339,499
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal2 under 35 U.S.C. § 134(a) involving claims to a
computer-assisted hip joint resurfacing system and method. The claims are
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is Orthosoft Inc. (App.
Br. 3).
2 The Appeal Brief is not properly paginated. Therefore, all references to
page numbers in the Appeal Brief refer to page numbers as if the Appeal
Brief was numbered consecutively beginning with the first page.
Appeal2014-008049
Application 11/339,499
STATEMENT OF THE CASE
The Specification describes "a method for assisting hip joint
resurfacing surgery with computer-assisted surgery systems" that purports to
"guid[e] an operator in inserting implants in hip joint resurfacing surgery"
(Spec. iTiT 2, 6).
Claims 1-15 are on appeal. Claim 1 is illustrative and reads as
follows (emphasis added):
1. A hip resurfacing CAS system for guiding an operator in
altering a femoral head in computer-assisted surgery for
subsequent implanting of a femoral head implant, comprising:
a trackable reference on the femur, the trackable reference
being trackable to form a femoral frame of reference of the
femur;
a registration tool being trackable;
a drill associated with a resurfacing of the femoral head,
the drill being trackable;
a cylindrical head-resurfacing reamer with a guide, the
cylindrical head-resurfacing reamer adapted to shape the
femoral head as a cylinder;
a tracking apparatus for tracking at least the trackable
reference, the registration tool and the drill; and
a resurfacing processing unit for receiving tracking data
for the trackable reference, the registration tool and the drill, the
resurfacing processing unit having:
a position/ orientation calculator to calculate from the
tracking data at least an orientation of the trackable reference to
track the femoral frame of reference, and of the registration tool
and the drill;
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Application 11/339,499
a model generator receiving data of the registration tool to
set a model of the femoral head and neck with respect to the
femoral frame of reference; and
a resurfacing evaluator determining an evaluated bone
resurfacing alteration of the femoral head and neck as a function
of a position and/or orientation of the drill with respect to the
bone model of the femoral head and neck, and a geometry model
of the cylindrical head-resurfacing reamer, at least prior to
resurfacing being perf armed.
The claims stand rejected as follows:
I. Claims 1-13 stand rejected under 35 U.S.C. § 103(a) as obvious
based on DiGioia,3 Sati,4 Long,5 and Ronningen.6
II. Claims 14 and 15 stand rejected under 35 U.S.C. § 103(a) as
obvious based on DiGioia, Sati, Long, Ronningen, and Tuke.7
I.
The Examiner has rejected claims 1-13 under 35 U.S.C. § 103(a) as
obvious based on DiGioia, Sati, Long, and Ronningen. We focus our
discussion on independent claims 1 and 9, as the corresponding dependent
claims are not separately argued.
3 DiGioia, III et al., US 6,205,411 Bl, issued Mar. 20, 2011.
4 Sati et al., US 2005/0203394 Al, published Sept. 15, 2005.
5 Long et al., US 2004/0193275 Al, published Sept. 30, 2004.
6 Ronningen et al., Total surface hip arthroplasty in dogs using a fiber metal
composite as a fixation method, 17 JOURNAL OF BIOMEDICAL MATERIALS
RESEARCH 643---653 (1983).
7 Tuke et al., US 2005/0245934 Al, published Nov. 3, 2005.
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Appeal2014-008049
Application 11/339,499
Findings of Fact
FF 1. DiGioia, discloses "[a]n apparatus for facilitating the
implantation of an artificial component in ... a hip joint .... The apparatus
includes a pre-operative geometric planner and a pre-operative kinematic
biomechanical simulator in communication with the pre-operative geometric
planner" (DiGioia, Abstract; see also Ans. 2-3).
FF 2. DiGioia, discloses
During the pre-operative stages of the method, the display
monitor [] is used for viewing and interactively creating and/or
generating models in the pre-operative planner[] and displaying
the results of the biomechanical simulator []. . . . During the
intra-operative stages of the method, the computer system [] is
used to display the relative locations of the objects being tracked
with a tracking device []. . . . The tracking device [] can employ
any type of tracking method as may be known in the art, for
example, emitter/detector systems including optic, acoustic or
other wave forms, shape based recognition tracking algorithms,
or video-based, mechanical, electromagnetic and radio
frequency (RF) systems. . . . The targets [] can be attached to
bones, tools, and other objects in the operating room equipment
to provide precision tracking of the objects.
(DiGioia, 6: 17--43; see also Ans. 2-3.)
FF 3. Di Gioia, discloses that
a femoral implant[] having a head, or ball, []and a neck, or shaft,
[] is implanted into a femur []. The femur [] has a head portion
[] that is removed to facilitate the implantation. A bore [] is
drilled in the femur [] into which the femoral implant [] is placed.
(DiGioia, 9:51-56; see also Ans. 2-3.)
FF 4. Sati discloses
[a] system [] is used to assist the surgeon in performing an
operation by acquiring and displaying an image of the pat[i]ent.
Subsequent movement of the patient and instruments is tracked
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Application 11/339,499
and displayed on the image. Images of a selection of implants
are stored by the system and may be called to be superimposed
on the image.
(Sati Abstract; see also Ans. 4--5.)
FF 5. Sati discloses that "the method includes the steps of using 3D
implant and instrument geometric models in combination with registered
medical images, generating 2D projections of that instrument and/or implant,
updating the 2D projection dynamically in real-time as the
implant/instrument is moved about in 3D space" (Sati i-f 12; see also Ans. 4--
5).
FF 6. Sati discloses
The "dynamic 2D template" from the 3D model provides both
the exact magnification and orientation of the planned implant
with the intuitive visual interface. This step also includes
generating a 2D projection of instruments [] onto 2D X-ray
images []. The instruments [] to be used on the patient [] while
performing the procedure are virtually represented on the images
[], and so are the implants.
(Sati i-f 52; see also Ans. 4--5.)
FF 7. Sati discloses that "[a]s the femur is being rasped, the length is
continuously calculated along the anatomical axis of the femur, Vfemur
relative to the femoral tracker, T f by monitoring the position of the reamer"
(Sati i-f 79; see also Ans. 4--5).
FF 8. Sati discloses that "[t]he system[] can help guide the femoral
reamer that prepares a hole down the femoral long axis for femoral
component placement to avoid what is termed femoral notching that can lead
to subsequent femoral fracture" (Sati i-f 83; see also Ans. 4--5).
FF 9. Sati discloses that "[ d]isposable components for a hip
instrumentation set include a needle pointer, a saw tracker, an optional cup
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Application 11/339,499
reamer tracker, a cup impactor tracker, a drill tracker (for femoral reamer
tracking), a rasp handle tracker, a[ n] implant tracker, and a calibration
block" (Sati i-f 88; see also Ans. 4--5).
FF 10. Long depicts in Figure 9 a "combination cutting tool or
reamer 680" (Long i-f 92). Figure 9 is reproduced below.
(Id. at Fig. 9.) Figure 9 shows "[t]he cutting tool or reamer 680 also
includes a cylindrical reamer 685 for preparing the humerus for receiving a
stem prosthesis" (Id. at i-f 92; see also Ans. 5).
FF 11. Ronningen discloses that "[t]he femoral head was reamed to a
cylindrical shape with a rotary cutter guided along the axis of the femoral
head and neck by a Steinmann pin drilled into the femoral head" (Ronningen
645; see also Ans. 5).
FF 12. The Specification discloses that "various types of reamers are
used to resurface the femoral head" (Spec. i-f 5). The Specification further
states that the femoral head [] is resurfaced, by way of a reamer. It is
contemplated to provide visual information to the operator at this step ....
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Application 11/339,499
Information that can be provided is as follows: Tracking for position and
orientation of the cylindrical reamer, .. . "(id. at i-f 52).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2-13; FF 1-12), and agree that the
claims are obvious over DiGioia, Sati, Long, and Ronningen. We address
Appellants' arguments below.
We begin with claim interpretation, because until a claim is properly
interpreted, its scope cannot be compared to the prior art. Claims 1 and 9
recite "a cylindrical head-resurfacing reamer." The Specification does not
specifically define "a cylindrical head-resurfacing reamer." Rather, the
Specification explains that "various types of reamers are used to resurface
the femoral head," and "[t]racking position and orientation" information
may be provided for the cylindrical reamer (FF 12).
Therefore, we conclude that the broadest reasonable interpretation of
the phrase "a cylindrical head-resurfacing reamer" includes any reamer that
is capable of resurfacing an object into a cylindrical form.
Appellants contend that because DiGioia does not disclose shaping
the femoral head as a cylinder, it cannot teach "a cylindrical head-
resurfacing reamer" (App. Br. 3; see also Reply Br. 2-3).
We are not persuaded. Rather, consistent with our claim
interpretation, set forth above, we agree with the Examiner that
it is well known to an ordinary artisan that the femoral head can
be rasped into any shape such as a cylinder by non-cylindrical
reamer -- i.e., the reamer does not have to be cylindrical in order
to shape the femoral head into a cylinder just as the cylindrical
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Application 11/339,499
torso of classical statues do not have to be shaped by cylindrical
chisels.
(Ans. 10). Furthermore, we also agree with the Examiner that Long teaches
a reamer that is capable of shaping the femoral head into a cylindrical form
(id. at 9; FF 10-11), and Ronnningen teaches reaming the femoral head into
a cylinder (Ans. 9-10; FF 11).
Appellants next contend that because Sati displays virtual
representation of a reamer in real-time, there is no evaluation or prediction
of the reamer before resurfacing the bone (App. Br. 11 ). More particularly,
Appellants argue that Sati does not teach evaluation prior to resurfacing (id.
at 11-12; see also Reply Br. 3--4).
We are not persuaded. As an initial matter, we note that the disputed
limitation, "at least prior to resurfacing being performed" appears in claim 1,
which is an apparatus claim, but not claim 9, which is a method claim. "A
patent applicant is free to recite features of an apparatus either structurally or
functionally .... Yet, choosing to define an element functionally, i.e., by
what it does, carries with it a risk." In re Schreiber, 128 F.3d 1473, 1478
(Fed. Cir. 1997). "'Functional' terminology may render a claim quite broad.
By its own literal terms a claim employing such language covers any and all
embodiments which perform the recited function." In re Swinehart, 439
F.2d 210, 213 (CCPA 1971). Accordingly, we conclude that the cited prior
art need only suggest a resurfacing evaluator that is capable of performing
the recited functions "at least prior to resurfacing being performed."
Moreover, DiGioia, teaches "[t]he apparatus includes a pre-operative
geometric planner" (FF 1 (emphasis added); see also Ans. 12-13), and Sati
teaches "[a] system [] is used to assist the surgeon in performing an
operation by acquiring and displaying an image of the pat[i]ent. Subsequent
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Application 11/339,499
movement of the patient and instruments is tracked and displayed on the
image" (FF 4; see also Ans. 11-12). "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).
II.
The Examiner has rejected claims 14 and 15 under 35 U.S.C. § 103(a)
as obvious based on DiGioia, Sati, Long, Ronningen, and Tuke.
Findings of Fact
FF 13. Tuke discloses that "[f]ailure to position the alignment guide
correctly may have the disastrous effect of allowing the machining of the
cylinder of the head during the shaping procedure to "notch" into the neck of
the femur. This will predispose the bone to early failure on load bearing"
(Tuke i-f 9; see also Ans. 8).
FF 14. Tuke discloses that "[t]hese cutters are arranged such that the
diameter cut will be correct for the head size chosen and will bottom on the
top of the cut head such that the teeth of the cutter do not dangerously over-
sail the head-neck junction and cause soft tissue damage or neck notching"
(Tuke i-f 46; see also Ans. 8), and that "whilst machining the head to the
required size will not impinge on the neck of the femur with the risk that it
will be notched" (Tuke i-f 46; see also Ans. 8).
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Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2-13; FF 1-14), and agree that the
claims are obvious over DiGioia, Sati, Long, Ronningen, and Tuke. We
address Appellants' arguments below.
Appellants contend that Tuke is unrelated to computer assisted
surgery and cannot teach virtual identification of a potential notch (App.
Br. 12; see also Reply Br. 2-3).
We are not persuaded. We conclude that the Examiner reasonably
relies on Tuke to suggest the identification a potential notch (Ans. 10; FF
13-14), and that it would have been obvious to combine the teaching of
Tuke with Di Gioia, Ronningen, Long, and Sati, in order to prevent failure on
load bearing (Ans. 8-10). "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'! Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007). "If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability." Id. at 417. See also In re Merck & Co.,
800 F.2d at 1097. We also note that Sati teaches "[t]he system[] can help
guide the femoral reamer that prepares a hole down the femoral long axis for
femoral component placement to avoid what is termed femoral notching that
can lead to subsequent femoral fracture" (FF 8 (emphasis added)).
SUMMARY
We affirm the rejection of claims 1 and 9 under 35 U.S.C. § 103(a)
based on DiGioia, Sati, Long, and Ronningen. Claims 2-8 fall with claim 1
and claims 10-13 fall with claim 9.
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Application 11/339,499
We affirm the rejection of claims 14 and 15 under 35 U.S.C. § 103(a)
based on DiGioia, Sati, Long, Ronningen, and Tuke.
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. § 1.136(a)(l )(iv).
AFFIRMED
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