Ex Parte O

Board of Patent Appeals and Interferences

Jun 23, 2008

10321814 (B.P.A.I. Jun. 23, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PAT D. O’DONNELL
__________

Appeal 2008-2120
Application 10/321,814
Technology Center 3700
__________

Decided: June 23, 2008
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to a surgical
instrument for securing body tissue. The Examiner has entered two
obviousness rejections against the claims. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm one of the rejections and reverse the other.
Appeal 2008-2120
Application 10/321,814

STATEMENT OF THE CASE
Claims 3, 4, 6, 19, and 20 are pending and on appeal (App. Br. 1).
Claims 4 and 19 are representative of the appealed subject matter and read as
follows:
4. A surgical instrument for securing body tissue
comprising:
an anchoring member formed from organic or inorganic
biocompatible material having head, shaft and tip portions,
said anchoring member having a substantially central
longitudinal axis extending substantially between said head
portion and said tip portion of said anchoring member;
said shaft portion comprising at least two generally
outwardly flaring fins with each of said fins having a proximal
portion, a distal portion and a side that, in its entirety, is directly
coupled to said shaft, said side having a substantially central
longitudinal axis extending substantially between said proximal
portion and said distal portion; and
said longitudinal axis of each fin configured in non-
parallel orientation to said longitudinal axis of said anchoring
member;
wherein said head portion further comprises a centrally
positioned eyelet accommodation through which a suture may
be inserted.

19. A surgical instrument for securing body tissue
comprising:
an anchoring member formed from organic or inorganic
biocompatible material having head, shaft and tip portions,
said anchoring member having a substantially central
longitudinal axis extending substantially between said head
portion and said tip portion of said anchoring member;
said shaft portion comprising at least two generally
outwardly flaring fins with each of said fins having a proximal
portion, a distal portion and a side that, in its entirety, is directly
coupled to said shaft, said side having a substantially central
longitudinal axis extending substantially between said proximal
portion and said distal portion; and
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said longitudinal axis of each fin configured in non-
parallel orientation to said longitudinal axis of said anchoring
member;
wherein each of said fins [sic] most proximal surface is
presented in an exaggerated curvature extending from a point
where said fin attaches to said anchor shaft and extending
outwardly to pointed tip portion of each fin.

The Examiner applies the following documents in rejecting the
claims:
Overaker et al. US 6,743,232 B2 Jun. 1, 2004
Törmälä et al. US 6,692,499 B2 Feb. 17, 2004
Frazier US 5,968,045 Oct. 19, 1999

The following rejections are before us for review:
Claims 3, 4, and 6 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Overaker and Frazier (Ans. 3-5).
Claims 19 and 20 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Overaker and Törmälä (Ans. 5-7).
OBVIOUSNESS -- OVERAKER AND FRAZIER
ISSUE
The Examiner contends that “Overaker discloses the invention
substantially as claimed except for the [limitation that the] head portion
further comprises a centrally positioned eyelet” (Ans. 3). The Examiner
cites Frazier as disclosing a tissue anchor member that meets that limitation,
and contends that one of ordinary skill in the art would have considered it
obvious “to incorporate the head portion including the eye, as disclosed by
Frazier . . . into the tissue anchor device as disclosed by Overaker, because
this will allow the surgeon to secure tissue such as the anterior cruciate
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ligament to the anchor for reconstructing of anterior cruciate ligament or
posterior cruciate ligament in the knee as suggested by Frazier” (id. at 5).
Appellant contends that the Examiner failed to present a prima facie
case of obviousness because the cited references would not have motivated
one of ordinary skill in the art to modify Overaker in the manner advanced
by the Examiner (App. Br. 5-8).
The issue with respect to this rejection, then, is whether the Examiner
has established a prima facie case of obviousness with respect to claims 3, 4,
and 6.
FINDINGS OF FACT (“FF”)
1. Claims 4 and 6 are the independent claims subject to this ground of
rejection. Claims 4 and 6 both recite a surgical instrument for securing body
tissue, the instrument essentially being a shaft having at least two outwardly
flaring fins oriented in a non-parallel fashion with respect to the shaft’s
longitudinal axis. Both claims require the head portion of the shaft to have
“a centrally positioned eyelet accommodation through which a suture may
be inserted.”
2. Appellant’s Figure 2, reproduced below, shows an embodiment of the
device recited in claims 4 and 6:
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Appellant’s Figure 2 shows shaft portion 41 with outwardly flaring
fins 9, 14, 24, 29, 34, 70, 73, and 76 oriented in a non-parallel manner with
respect to the shaft’s longitudinal axis (see Spec. 10-11). The figure also
shows “head portion 40 [which] further comprises an eyelet accommodation
60 through which a suture may be inserted” (id. at 11).
3. Overaker discloses “scaffold fixation devices useful in articular
cartilage repair[,] and more specifically . . . a device for fastening an
articular cartilage scaffold to underlying bone” (Overaker, col.1, ll. 6-9).
Overaker’s device is intended to repair damaged portions of the cartilage
that covers the articulating surfaces between bones in joints, such as the knee
or elbow, by providing a “tissue scaffold that serves as an architectural
support onto which cells may attach, proliferate, and synthesize new tissue
to repair a wound or defect” (id. at col. 1, ll. 20-22).
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4. Overaker states that “[s]urgical use of a tissue scaffold requires a
fixation means to secure the scaffold to the bone beneath the wounded
cartilage site. Secure fixation of the scaffold within the wound site is
necessary for proper healing” (Overaker, col. 1, ll. 22-26).
5. Figure 2 of Overaker, reproduced below, shows “a perspective view
of scaffold fixation device 10 showing perforations 20 in disk-shaped
platform 12 that allow fluid and cells to travel to and from the scaffold
promoting cell proliferation and ingrowth” (Overaker, col. 2, ll. 56-59):

Also visible in Overaker’s Figure 2 are “[v]ertical ribs 16 [which]
extend along a portion of the length of the post 14 and taper downwards in
width and height as they extend from edge 17 to [the] chamfered distal tip”
(id. at col. 2, ll. 45-47). Overaker discloses that the “taper of vertical ribs 16
enhances the ability of the vertical ribs 16 to gradually cut into surrounding
bone during insertion of scaffold fixation device 10 into an appropriately
sized hole in a bone to which the device 10 is attached” (id. at col. 2, ll. 47-
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51). Overaker discloses that the tapered ribs also “prevent rotation of the
device relative to the bone tissue” (id. at col. 2, ll. 19-20).
6. Figure 3 of Overaker, reproduced below, “shows a side elevation view
of scaffold fixation device 10 which has been surgically positioned within a
hole 40 drilled in bone tissue 42” (Overaker, col. 3, ll. 4-6):

Overaker’s Figure 3 shows the “diameter of the hole 40 is . . . such that an
interference fit is made between the hole 40 and post 14 with vertical ribs
16” (Overaker, col. 3, ll. 6-8).
Overaker’s Figure 3 also shows “hole 44 . . . drilled in cartilage tissue
46 with a diameter at least as large as the outermost diameter of platform 12
to accommodate the platform 12 therein in a position permitting the scaffold
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47 (shown diagrammatically in dotted lines and displaced slightly) to be
attached to the device 10 by sutures or adhesives, in a known manner”
(Overaker, col. 3, ll. 23-29).
7. Regarding Figure 3, Overaker further discloses:
The depths of hole 40 in the bone and the hole 44 in the
cartilage are selected such that, when post 14 is inserted
completely into hole 40, upper surface 50 of platform 12 is in
alignment with or slightly below upper surface 52 of the bone
tissue 42, i.e., the platform 12 may be countersunk into the bone
42. The scaffold 47 is accommodated within hole 44 in the
cartilage (between platform 12 and upper cartilage surface 54).

(Overaker, col. 3, ll. 29-36.)
8. Overaker does not disclose that platform 12 of its device has an eyelet
through which a suture may be inserted, as required by claims 4 and 6.
9. Frazier discloses “an anchoring device for use in reconstructing torn
ligament connections, such as the anterior cruciate ligament (ACL) in the
knee” (Frazier, col. 1, ll. 5-7). Frazier’s device includes a “fixation screw
[which] has a threaded shank portion that can be inserted into bone and a
head portion formed with an eyelet through which a graft, such as an
autograft, an allograft or a prosthetic ligament, can be looped” (id. at col. 1,
ll. 10-14).
10. Figure 4 of Frazier, reproduced below, “is a front view of the
preferred form of the fixation screw of the present invention inserted over a
guide drill” (Frazier, col. 4, ll. 39-42):

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Frazier Figure 4 shows a fixation screw “formed with one or more
flutes 12 in the shank portion 9 and thread 10 to improve the ability of the
thread 10 to tap into cancellous bone. As is also shown in FIG. 4, the thread
10 extends from the distal end 4 of the body member 3 to better anchor the
fixation screw in bone” (Frazier, col. 5, ll. 51-57). Frazier’s Figure 4 also
shows “central axis 6 bisect[ing] the eyelet 13” (id. at col. 5, l. 67).
11. Figure 3 of Frazier, reproduced below, “is a schematic cross section of
a knee in flexion” with the device deployed in it (Frazier, col. 4, ll. 33-34):

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In Frazier’s Figure 3, “[p]ortions of the femur and tibia are shown. The
fixation screw [3] is shown placed in the femur. Two grafts are received by
the eyelet of the fixation screw. The two grafts are shown attached to the
tibia cortical surface with bone staples near the entrance of the tibial tunnel”
(Frazier, col. 4, ll. 34-38).
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PRINCIPLES OF LAW
In proceedings before the Patent and Trademark Office,
the Examiner bears the burden of establishing a prima facie
case of obviousness based upon the prior art. “[The Examiner]
can satisfy this burden only by showing some objective
teaching in the prior art or that knowledge generally available to
one of ordinary skill in the art would lead that individual to
combine the relevant teachings of the references.”

In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992) (citations omitted,
bracketed material in original).
As the Supreme Court pointed out, “it can be important to identify 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 . . .
because inventions in most, if not all, instances rely upon building blocks
long since uncovered, and claimed discoveries almost of necessity will be
combinations of what, in some sense, is already known.” KSR Int'l v.
Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). Thus, “[i]n determining whether
obviousness is established by combining the teachings of the prior art, the
test is what the combined teachings of the references would have suggested
to those of ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581
(Fed. Cir. 1995) (internal quotations omitted).
When evaluating claims for obviousness, “the prior art as a whole
must be considered. The teachings are to be viewed as they would have
been viewed by one of ordinary skill.” In re Hedges, 783 F.2d 1038, 1041
(Fed. Cir. 1986). Moreover, “‘[i]t is impermissible within the framework of
section 103 to pick and choose from any one reference only so much of it as
will support a given position, to the exclusion of other parts necessary to the
full appreciation of what such reference fairly suggests to one of ordinary
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skill in the art.’” Id. (quoting In re Wesslau, 353 F.2d 238, 241 (CCPA
1965)).
ANALYSIS
We do not agree with the Examiner that one of ordinary skill viewing
the Overaker and Frazier references would have been prompted to place the
eyelet from Frazier’s ligament-securing device on to Overaker’s scaffold
fixation device. We note, as argued by the Examiner (Ans. 7-8), that
Frazier’s eyelet is suitable for securing ligament grafts to bone in ligament
repair surgeries (see FF 9-11).
However, Overaker’s device is constructed for a much different use --
supporting a tissue scaffold used in repairing articular cartilage within a knee
or elbow joint (see FF 3, 5, 6). Thus, rather than supporting ligament
attachment, Overaker’s device is configured to lie under and support a tissue
scaffold consisting of cells that act to repair damaged cartilage (FF 3, 5, 6,
7).
We do not see, and the Examiner has not explained, how the objective
of Overaker’s device, supporting cells for articular cartilage repair, would in
any way be furthered by adding to it Frazier’s ligament-attaching eyelet.
Nor has the Examiner explained why one of ordinary skill would have
considered it desirable to modify a device that underlies articular cartilage to
have a ligament-attaching eyelet. Because the two devices are configured to
solve distinct problems, we do not agree with the Examiner that a person of
ordinary skill would have modified Overaker’s device in the manner posited
by the Examiner.
We therefore agree with Appellant that the Examiner has not made
out a prima facie case of obviousness based on Overaker and Frazier, and
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reverse the Examiner’s rejection of claims 3, 4, and 6 as being obvious over
those references.
OBVIOUSNESS -- OVERAKER AND TÖRMÄLÄ
Claims 19 and 20 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Overaker and Törmälä (Ans. 5-7).
The Examiner cites Overaker as disclosing “the invention
substantially as claimed except for [the limitation that] the fin[’]s most
proximal surface is presented in an exaggerated curvature extending from a
point where the fin attaches to anchor shaft and extending outwardly to
pointed tip portion of each fin” (Ans. 6). The Examiner cites Törmälä to
meet that limitation, and reasons that one of ordinary skill in the art would
have been prompted to incorporate Törmälä’s fins into Overaker’s device
“because this would have been an obvious matter of design choice to choose
this design for the purpose of preventing the anchor from dislodging from
the site after deployment as suggested by [Törmälä]” (id. (citing Törmälä,
col. 5, ll. 35-40)).
Appellant urges that the Examiner’s “design choice” rationale “is
insufficient to establish a prima facie case of obviousness in rejecting claims
19 and 20” (App. Br. 9; see also Reply Br. 4-6).
The issue with respect to this rejection, then, is whether the Examiner
has established a prima facie case of obviousness with respect to claims 19
and 20.
FINDINGS OF FACT (“FF”)
12. Claims 19 and 20 both recite a surgical instrument for securing body
tissue, the instrument essentially being a shaft having at least two outwardly
flaring fins oriented in a non-parallel fashion with respect to the shaft’s
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longitudinal axis. Both claims require the most proximal surface of each of
the fins to be “presented in an exaggerated curvature extending from a point
where said fin attaches to said anchor shaft and extending outwardly to
pointed tip portion of each fin.”
13. Appellant’s Figure 8, reproduced below, shows an embodiment of
Appellant’s surgical anchor that “comprises fins which embody an
exaggerated curvature along each of [the] fins [sic] most proximal surface”
(Spec. 8):

Appellant’s Figure 8 shows “fin-like structures 100 with an
exaggerated curvature extending along each of anchor's fins [sic] most
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proximal surface 101 and extending from the point 102 where each of said
fins is joined to shaft 41 and extending outwardly along each of said fins
[sic] most proximal surface to the end of each of said fins outward most tip
103” (Spec. 12). The exaggerated curvature of the proximal surfaces of the
fins gives the fins a barb-like shape, with the point of the barb pointing
toward the head 50, as opposed to the tip, of the device.
14. Törmälä discloses an arrow-shaped surgical fastener that has a “shaft
with a proximal (first) portion having protrusions and a blunt end and a
distal (second) portion having protrusions and a pointed end, the protrusions
of the proximal and distal portions configured to lock the implant in a
position inside a soft and/or tough tissue according to the use of the implant”
(Törmälä, col. 1, ll. 9-15).
15. Törmälä discloses that its fastener “is particularly but not solely
intended to be used in repair surgery of traumas of soft and/or tough tissues
containing fibrous structures, such as knee meniscal tissues” (Törmälä, col.
1, ll. 21-24). Figure 5 of Törmälä, reproduced below, shows an embodiment
of Törmälä’s fastener in which “the slopes of [the] protrusions are curved”
(id. at col. 4, ll. 37-38):

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The Figure shows Törmälä’s anchoring device with the protrusions
adjacent to the pointed tip having curved front and rear surfaces. The
protrusions have a barb-like shape very similar to the fins described in
Appellant’s Specification as having an exaggerated curvature on the
proximal surfaces of the fins.
16. Törmälä discloses that the configurations of the protrusions on its
device “guarantee the effective prevention of slipping of the fastener back in
the direction opposite to the installation direction after installation of the
fastener” (Törmälä, col. 5, ll. 37-39).
PRINCIPLES OF LAW
Emphasizing a flexible approach to the obviousness issue, the
Supreme Court nonetheless emphasized that “[r]ejections 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.” KSR Int'l v. Teleflex Inc., 127
S. Ct. 1727, 1741 (2007) (quoting In re Kahn, 441 F.3d 977, 988, (Fed. Cir.
2006) (emphasis added).
The Supreme Court also indicated, however, that it is obvious to apply
known solutions to a problem recognized in the prior art:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

Id. at 1742.
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ANALYSIS
We agree with the Examiner that claims 19 and 20 would have been
prima facie obvious to one of ordinary skill in the art viewing Overaker and
Törmälä. One of ordinary skill in the art using Overaker’s device to repair
the articular cartilage of a joint, such as the meniscal tissue of the knee (see
FF 3, 5, and 7), would have been informed by Overaker that fixing the
device securely in place was critical for promoting healing of the tissue
under repair (FF 4). One of ordinary skill would have been further advised
by Törmälä that giving Overaker’s tapered ribs a configuration with an
exaggerated curve would have ensured that the device would stay in place
once implanted (see FF 14-16).
We therefore agree with the Examiner that one of ordinary skill in the
art, advised by Törmälä that the claimed fin configuration was a suitable
solution to the problem of securely fastening surgical implants used in
repairing articular cartilage, would have been prompted to use that fin
configuration on Overaker’s device. Given the references’ teachings, the
Examiner has, in our view, made out a prima facie case of obviousness.
Appellant’s arguments do not persuade us to the contrary. While we
note that the Examiner used the term “design choice” as part of the
rejection’s rationale, the Examiner specifically urged that the reason for
choosing Törmälä’s design was to “prevent[] the anchor from dislodging
from the site after deployment as suggested by [Törmälä]” (Ans. 6, 8 (citing
Törmälä, col. 5, ll. 35-40)).
Thus, contrary to Appellant’s arguments, the Examiner provided a
sound prior art-based reason for using Törmälä’s fins on Overaker’s device
-- to ensure secure fixation of the device -- which Overaker discloses as
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being critical to proper tissue healing. Therefore, because the Examiner has
shown that claims 19 and 20 recite a known solution to an art-recognized
problem, see KSR, 127 S. Ct. at 1742, we agree with the Examiner that one
of ordinary skill in the art would have considered those claims prima facie
obvious in view of Overaker and Törmälä. Because Appellant has not
provided, nor do we see, any evidence that anything unexpected results from
the claimed devices, we affirm the Examiner’s obviousness rejection of
claims 19 and 20.
SUMMARY
We reverse the Examiner’s rejection of claims 3, 4, and 6 under 35
U.S.C. § 103(a) as being unpatentable over Overaker and Frazier.
We affirm the Examiner’s rejection of claims 19 and 20 under 35
U.S.C. § 103(a) as being unpatentable over Overaker and Törmälä.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED-IN-PART

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