Ex Parte Warburton et al

Patent Trial and Appeal Board

Dec 20, 2016

11948189 (P.T.A.B. Dec. 20, 2016)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
W63747 1130.2 2309
EXAMINER
SUMMITT, LYNNSY M
ART UNIT PAPER NUMBER
3733
MAIL DATE DELIVERY MODE
11/948,189 11/30/2007
8933 7590 12/20/2016
DUANE MORRIS LLP - Philadelphia
IP DEPARTMENT
30 SOUTH 17TH STREET
PHILADELPHIA, PA 19103-4196
Mark J. Warburton
12/20/2016 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 MARK J. WARBURTON, ROBERT M. FENCL, JOHN T. CAPO,
VIRAK TAN, and AARON C. SMITH
Appeal 2015-001280
Application 11/948,189
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and ROBERT A. POLLOCK,
Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the Examiner’s
rejection of claims 4—9, 11, 13, 15—21, 23—25, and 27. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The Specification discloses “an intramedullary fixation assembly
usable with different long bone types and a guide assembly for guiding
deployment of the intramedullary fixation assembly.” Spec. 2, | 8.
1 Appellants identify the Real Party in Interest as Wright Medical Technology, Inc.
Br. 2.
Appeal 2015-001280
Application 11/948,189
Claim 4 is illustrative of the claims on appeal (emphasis added):
4. An intramedullary fixation member for use in repairing a distal
radius bone fracture, the distal radius having an articular surface,
comprising:
an elongate single-piece fixation member sized for insertion into the
medullary canal of the radius, the fixation member having opposed convex
and concave surfaces, and opposed substantially planar side surfaces
extending between the convex and concave surfaces, each of the convex,
concave, and side surfaces extending between opposing first and second
longitudinal ends of the fixation member, each of the convex and concave
surfaces being arcuate between the first and second longitudinal ends, with
at least the convex and concave surfaces being convergent toward the second
longitudinal end, the second end adapted for placement within the medullary
canal distal from the articular surface of the distal radius;
the fixation member defining a first fastener opening extending from
the convex surface to the opposing concave surface, and
a second fastener opening extending from a first one of the opposing
side surfaces to a second one of the opposing side surfaces;
the fixation member having a substantially planar guide attachment
surface about the first longitudinal end, with the first fastener opening being
defined by the fixation member between the guide attachment surface and
the second fastener opening,
the guide attachment surface extending from the concave surface
away from the second longitudinal end, and being adapted to form a positive
fit with a mating surface of a guide assembly adapted for guiding placement
and fixation of the elongate fixation member in the medullary canal; and
the fixation member defining a third fastener opening extending
through the guide attachment surface and the convex surface at an angle
that is substantially perpendicular to the guide attachment surface.
2
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Application 11/948,189
The claims stand rejected under 35 U.S.C. § 103(a) as follows:
claims 4, 9, 13, 15, and 19 in view of Warburton2 and Gradl;3
claims 5—7, 20, and 21 in view of Warburton, Gradl, and Leu;4
claim 8 in view of Warburton, Gradl, and Castaneda;5
claim 11 in view' of Warburton, Gradl, and Gnos;6
claim 16 in view of Warburton, Gradl, and Biihren;7
claims 17, 18, and 27 in view of Warburton, Gradl, and Weaver;8
claim 23 in view of Warburton, Gradl, Leu, and Biihren;
claim 24 in view' of Warburton, Gradl, Leu, and Weaver; and
claim 25 in view of Warburton, Gradl, Leu, Biihren, and Weaver.
I.
The Examiner has rejected claims 4, 9, 13, 15, and 19 under 35 U.S.C.
§ 103(a) as obvious in view of Warburton and Gradl. Ans. 2—6. The
Examiner has also rejected claims 5—8, 11, 16—18, 20, and 27 under 35
U.S.C. § 103(a) as obvious in view of Warburton and Gradl, and further in
view of one or more of Leu, Castaneda, Gnos, Biihren, and Weaver. Ans. 6—
21. The same issues are dispositive for all of these rejections, and we will
consider them together.
2 Warburton, US 6,527,775 Bl, Mar. 4, 2003.
3 Gradl, EP 1330988 A2, July 30, 2003.
4 Leu et al., US 6,270,499 Bl, Aug. 7, 2001.
5 Castaneda, US 6,926,720 B2, Aug. 9, 2005.
6 Gnos et al., US 6,629,976 Bl, Oct. 7, 2003.
7 Biihren et al., US 6,547,791 Bl, Apr. 15, 2003.
8 Weaver et al., US 6,623,486 Bl, Sep. 23, 2003.
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Appeal 2015-001280
Application 11/948,189
The issues: Does the evidence of record support the Examiner’s
conclusion that the combination of Warburton and Gradl would have made
obvious an intramedullary fixation member that comprises “a first fastener
opening extending from the convex surface to the opposing concave
surface” and “a third fastener opening extending through the guide
attachment surface and the convex surface at an angle that is substantially
perpendicular to the guide attachment surface,” as required by claim 4?
Analysis
We have reviewed Appellants’ contentions that the Examiner erred in
rejecting claims 4, 9, 13, 15, and 19 as obvious over the cited art. App. Br.
18—24. We disagree with Appellants’ contentions and adopt the findings
concerning the scope and content of the prior art set forth in the Examiner’s
Answer and Final Rejection.9 For emphasis, we highlight and address the
following:
FF1. Warburton discloses “an internal fixation device for treating or
repairing distal radius fractures having a fracture line forming distal and
proximal fracture fragments.” Warburton, col. 2,11. 62—65. “The device
includes an elongated fixation rod having opposing proximal and distal
portions. The distal portion includes a head with a laterally extending distal
aperture formed therein, and the proximal portion comprises at least one
proximal aperture formed therein.” Warburton, col. 3,11. 6—11.
FF2. Figure 3 A of Warburton is shown below:
Office Action mailed Jan. 14, 2014.
4
Appeal 2015-001280
Application 11/948,189
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Figure 3 A shows an “anterior-posterior view of an intramedullary fixation
rod attached to the radius for treating a distal radius fracture.” Warburton,
col. 3,11. 51—53. “[T]he intramedullary fixation device 25 includes an
elongated axially extending rod 26 with a distal portion 27 and a proximal
portion 28.” Warburton, col. 5,11. 4—7. “[Djevice 25 also includes a distal
fixation member 30 and at least one proximal fixation member 35 (shown as
two proximal fixation members 35a, 35/?).” Warburton, col. 5,11. 7—10.
“[R]od 26 includes a head 26h at the distal end portion 27 of the rod 26. A
distal aperture 30a is formed into the head 26/? of the distal portion such that
it extends across the width of the rod 26.” Warburton, col. 5,11. 10-13.
FF3. Warburton discloses that “distal fixation member 30 is
configured to enter and extend through and beyond the distal aperture 30a to
engage with the distal fracture fragment 18 and secure the rod 26 and the
distal fracture fragment 18” together. Warburton, col. 5,11. 14—17.
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Appeal 2015-001280
Application 11/948,189
FF4. Warburton discloses that, in a preferred embodiment, “the rod
26 is configured with a profile 26p which, is curvilinear when viewed from
the anterior-posterior view.” Warburton, col. 5,11. 55—57 and Figs. 3A and
4.
FF5. Warburton discloses that it is
preferred that the distal aperture Mia be formed in the rod 26 such
that it allows the distal fixation member 30 to extend
therethrough and reside at a position which is angularly offset
from the axial axis . . . [which] is coincident with the centerline
of the proximal portion of the rod (indicated by the letter “a” in
FIG. 3 A). Preferably, the distal fixation member 30 extends at a
position which is less than about ninety degrees, and preferably
between about 10 degrees to less than about 90 degrees, away
from the axial axis, such that it is approximately in-line with the
articular surface.
Warburton, col. 6,11. 11—21.
FF6. Warburton discloses that, preferably, “two or more[] proximal
fixation members 35 are used to secure the rod 26 to the shaft region 13 of
the radius 10 at the lower or proximal portion of the rod 26.” Warburton,
col. 6,11. 31—33. “FIG. 3 A illustrates the use of two similarly sized proximal
fixation members 35a, 35b.” Warburton, col. 6,11. 33—35.
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Appeal 2015-001280
Application 11/948,189
FF7. Figure 6 of Warburton is shown below:
-—-SSh
is
Figure 6 shows “a perspective view of an intramedullary' fixation device.”
Warburton, col. 4,11. 1—2. Warburton discloses that, in the embodiment
shown in Figure 3A (discussed above), “the head of the distal fixation
member 30// extends beyond the edge of the body of the rod 26.”
Warburton, col. 5,11. 41—43. Warburton discloses that the aperture “can also
be configured (such as with a countersunk or recessed portion configured
with a depth sufficient: to receive the head 30/? therein) such, that. . . the
distal fixation member head 30// is substantially flush or recessed with the
4 4 VV 4.f V* p V-liiAA^O ?.M V til i Uil^vU 1 \V 1 4-“ V.- > !.v .1._4.- v.C4S.xV.'.54 VIV-411V1 _4\J i K.4.4.D 1 ^ |j i_ >
“The openings may be formed such that bone fixation elements substantially
can be passed through them parallel to each other.” Gradl, f 16. Gradl
discloses that, in a preferred embodiment, “the longitudinal axes of several
openings ... are inclined relative to each other.” Gradl, f 16.
With respect to the second and third fastener openings set forth in
claim 4, the Examiner finds that Warburton’s “fixation member defm[es] a
pair of second fastener openings 25al and 25a2” that extend from one side
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Application 11/948,189
surface to the other side surface. Ans. 3, citing Warburton, Figs. 3 A and 5 A.
The Examiner also finds that Warburton’s “fixation member defm[es] a third
fastener opening 30a .. . [that] extend[s] through the guide attachment
surface and the convex surface at an angle that is substantially perpendicular
to the guide attachment surface.” Ans. 3, citing Warburton, Figs. 3 A, 6, and
16.
With respect to the first fastener opening of claim 4, the Examiner
relies on Gradl, which discloses a fixation member having “a plurality of
fastener openings 6 at the guide surface end 3 of the fixation member.” Ans.
4, citing Gradl, Figs. 4, 5, and 12. The Examiner finds that Gradl discloses a
first fastener opening “between the guide attachment surface and a second
fastener opening . . . [and] the plurality of fastener openings extend[] at
different, divergent angles with respect to each other, for the purpose of
providing a fixation device which can effectively stabilize a number of bone
fragments.” Ans. 4, citing Gradl, 116 and Fig. 12.
The Examiner concludes that, in view of Gradl, it would have been
obvious to one of ordinary skill in the art to modify Warburton’s fixation
member “to have a plurality of fastener openings at the guide surface end of
the fixation device . . . [with] a first fastener opening . . . between the guide
attachment surface and a second fastener opening,” wherein the fastener
openings have divergent angles, in order to provide a fixation device for
bone fragment stabilization. Ans. 5, citing Gradl, 116. The Examiner
reasons that such a modification would “result in a fixation device having
... a first fastener opening extending from the convex surface to the
opposing concave surface in[]between the third fastener opening . . . which
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Application 11/948,189
extends through the guide attachment surface . . . and the pair of second
fastener openings 25al and 25a2.” Ans. 5.
Appellants argue that the Examiner errs in relying on Warburton’s
“distal aperture 30a .. . [as] meeting the elements of the claimed third
fastener opening” because claim 4 requires that the third fastener opening
“extend[s] through the guide attachment surface and the convex surface at an
angle that is substantially perpendicular to the guide attachment surface”
See App. Br. 19. In particular, Appellants argue that Warburton’s Figure 6
is merely “a schematic representation of the intramedullary nail 26 of FIG.
3A in an embodiment in which the distal aperture includes a recess” {id.,
citing Warburton, col. 5,11. 43 49) and that Warburton’s “distal aperture 30a
does not extend ‘substantially perpendicular’ to the purported guide
attachment surface near reference numeral 26h . . . [but] extends at a non­
perpendicular angle with respect to the purported guide attachment surface.”
Id. at 27, citing Warburton, Figs. 3A and 16. In support, Appellants provide
the following annotated version of a portion of Warburton’s Figure 3 A and
Figure 16:
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Appeal 2015-001280
Application 11/948,189
App. Br. 20, see FF8 for Warburton’s Figure 16. The above figures are
annotated with two dashed arrows and text stating that the arrows indicate
directions that are “[perpendicular to head 26h of [the] intramedullary
fixation device” and the “[direction of extension of distal aperture 30A,”
respectively. Id.
Appellants’ argument is not persuasive. First, Appellants point to no
evidence suggesting that one of ordinary skill in the art would not be able to
discern a perpendicular direction based on a schematic. And second, to the
extent Warburton’s Figures 3 A and 16 may not clearly show that aperture
30a extends “through the guide attachment surface ... at an angle that is
substantially perpendicular to the guide attachment surface,” as required by
claim 4, this feature is clearly evident in Warburton’s Figure 6. See FF7.
Appellants further argue that the Examiner errs in relying on Gradl
fastener openings 6 with respect to the claimed “first fastener opening
extending from a convex surface to an opposing concave surface.” See App.
Br. 21. In particular, Appellants argue that Gradl is directed to “an implant 1
configured to have the features and advantages of 1) a locking nail and 2) a
bone plate,” wherein “the bores 6 are part of the [bone] plate 3 and function
therewith to receive fasteners and secure multiple pieces of bone together.”
App. Br. 22. Accordingly, Appellants argue, “modification of the
intramedullary nail disclosed in Warburton to include the bores 6 disclosed
in Gradl in the manner suggested by the Examiner is improper” because “the
Examiner attempts to modify the intramedullary nail disclosed in Warburton
to include the bores 6 disclosed in Gradl without also including the [bone]
plate 3.” App. Br. 21—22 (citations omitted).
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Appeal 2015-001280
Application 11/948,189
Appellants’ argument is not persuasive. “The test for obviousness is
not whether the features of a secondary reference may be bodily
incorporated into the structure of the primary reference; nor is it that the
claimed invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of the references
would have suggested to those of ordinary skill in the art.” In re Keller, 642
F.2d 413, 425 (CCPA 1981) (citations omitted). Gradl discloses an implant
for insertion into the intramedullary canal of a long bone to repair fractures
such as a distal radius fracture. FF9--FF12. Gradl discloses that the distal
portion of the implant may comprise a number of openings to hold fasteners
at various angles. FF10-FF12, It would have been obvious to one of
ordinary skill in the art that incorporating multiple openings or apertures in
the distal end of the fixation rod disclosed in Warburton would provide a rod
with greater flexibility for bone fragment attachment points. Thus, we agree
with the Examiner that it would have been obvious for one of ordinary skill
in the art to incorporate Gradl’s concept of multiple openings or apertures
into Warburton’s fixation rod “for the purpose of providing a fixation device
which can effectively stabilize a number of bone fragments,” as forth at page
5 of the Answer.
Appellants argue that modifying Warburton’s intramedullary nail, in
view of Gradl, “to include the plate 3 and bores 6 cannot meet the claim
elements” because Gradl’s plate 3 is “flat and planar” such that the
“combination of Gradl with Warburton would result in bores extending
between flat surfaces, rather than between convex and opposing concave
surfaces,” as required by claim 4. App. Br. 22—24. Appellants’ argument is
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Application 11/948,189
not persuasive. As discussed above, one of skill in the art would have
combined Gradl’s multiple apertures that are inclined relative to each other
for bone fixation with the concave/convex intramedullary fixation rod 26 of
Warburton. Thus, the bores would extend between opposing convex and
concave surfaces.
Thus, we affirm the rejection of claim 4 under 35 U.S.C. § 103(a).
Claims 9, 13, 15, and 19 have not been argued separately and therefore fall
with claim 4. See 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner has also rejected dependent claims 5—8, 11, 16—18, 20,
and 27 under 35 U.S.C. § 103(a) as obvious in view of Warburton and
Gradl, and further in view of one or more of Leu, Castaneda, Gnos, Biihren,
and Weaver. Ans. 6—21. For these rejections, Appellants argue that Leu,
Castaneda, Gnos, Biihren, and Weaver do not cure the deficiencies of
Warburton and Gradl in making obvious the intramedullary fixation member
of claim 4. App. Br. 24. We affirm the rejections of claims 5—8, 11, 16—18,
20, and 27 for the reasons discussed above and as set forth by the Examiner.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
combination of Warburton and Gradl would have made obvious an
intramedullary fixation member that comprises “a first fastener opening
extending from the convex surface to the opposing concave surface” and “a
third fastener opening extending through the guide attachment surface and
the convex surface at an angle that is substantially perpendicular to the guide
attachment surface,” as required by claim 4.
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Application 11/948,189
II.
The Examiner has rejected claim 21 under 35 U.S.C. § 103(a) as
obvious in view of Warburton, Gradl, and Leu. Ans. 6—11. The Examiner
has also rejected dependent claims 23 and 24 under 35 U.S.C. § 103(a) as
obvious in view of Warburton, Gradl, and Leu, and further in view of either
Biihren (claim 23) or Weaver (claim 24). Ans. 15—16. The same issues are
dispositive for all of these rejections and we will consider them together.
Independent claim 21 reads as follows (emphasis added):
21. An intramedullary fixation member for use in repairing a distal
radius bone fracture, the distal radius having an articular surface,
comprising:
an elongate single-piece fixation member configured and sized for
insertion into the medullary canal of the distal radius, the fixation member
having opposed convex and concave surfaces, and opposed substantially
planar side surfaces extending between the convex and concave surfaces,
each of the convex, concave, and side surfaces extending between opposing
first and second longitudinal ends of the fixation member, each of the
convex and concave surfaces being arcuate between the first and second
longitudinal ends, with at least the convex and concave surfaces being
convergent toward the second longitudinal end, the second end configured
for placement within the medullary canal distal from the articular surface of
the distal radius;
the fixation member defining a first pair offastener openings
extending from the convex surface to the opposing concave surface proximal
to the first end of the elongate fixation member, the first pair offastener
openings being oriented at different, divergent angles with respect to each
other, and
a second pair of fastener openings extending from a first one of the
opposing side surfaces to a second one of the opposing side surfaces and
distal to the first pair of fastener openings;
the fixation member having a substantially planar guide attachment
surface about the first longitudinal end, with the first pair of fastener
openings being defined by the fixation member between the guide
attachment surface and the second pair of fastener openings, the guide
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Application 11/948,189
attachment surface extending from the concave surface away from the
second longitudinal end, and defining a plurality of indentations adapted for
forming a positive fit with a plurality of prongs extending from a mating
surface of a guide assembly adapted for guiding placement and fixation of
the fixation member in the medullary canal; and
the fixation member defining a third fastener opening extending from
the guide attachment surface to the convex surface at an angle that is
substantially perpendicular to the guide attachment surface, the plurality of
indentations being spaced around the third fastener opening and extending
from the third fastener opening to an outer periphery of the guide attachment
surface.
The issue: Does the evidence of record support the Examiner’s
conclusion that the combination of Warburton, Gradl, and Leu would have
made obvious an intramedullary fixation member that comprises “a first pair
of fastener openings extending from the convex surface to the opposing
concave surface proximal to the first end of the elongate fixation member,
the first pair of fastener openings being oriented at different, divergent
angles with respect to each other” and “a third fastener opening extending
through the guide attachment surface and the convex surface at an angle that
is substantially perpendicular to the guide attachment surface,” as required
by claim 21?
Analysis
For the rejection of claim 21, the Examiner relies on Warburton and
Gradl as discussed above. Ans. 8—10. The Examiner further relies on Leu
as “teach[ing] a fixation member having a plurality of indentations 26 being
spaced around a third fastener opening 27 . . . [with] the indentations being
adapted for forming a positive fit with a plurality of prongs extending from a
mating surface of a guide assembly.” Ans. 10, citing Leu, col. 4,11. 10-12
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and Fig. 2. The Examiner finds that “the indentations serv[e] the purpose of
securely attaching the guide assembly to the fixation device.” Ans. 10.
The Examiner concludes that, in view of Gradl, it would have been
obvious to one of ordinary skill in the art to modify Warburton’s fixation
device “to include a first pair of fastener openings extending through the
convex and concave surfaces proximal to the first end of the elongate
fixation member, the first pair of fastener openings being oriented at
different, divergent angles with respect to each other ... for the purpose of
providing a fixation device which can effectively stabilize a number of bone
fragments.” Ans. 10, citing Gradl, 116. The Examiner further concludes
that it would have been obvious one of ordinary skill in the art “to modify
the fixation device to include a plurality of indentations adapted for forming
a positive fit with a plurality of prongs extending from a mating surface of a
guide assembly ... for the purpose of securely attaching the guide assembly
to the fixation device.” Ans. 11.
Appellants present similar arguments as those presented for claim 4
above. That is, Appellants argue that the combination of Warburton and
Gradl would not have made obvious an intramedullary fixation member with
a first pair of fastener openings, a pair of second fastener openings, and a
third fastener opening, as recited in claim 21. App. Br. 26—31. Appellants
argue that Leu “fails to cure the deficiencies of Warburton and Gradl with
respect to the claimed first pair of fastener openings and the claimed third
fastener opening.” App. Br. 31—32.
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Appellants’ arguments are not persuasive for the reasons discussed
above. Thus, we affirm the rejection of claim 21 as being obvious in view of
Warburton, Gradl, and Leu.
The Examiner has also rejected claims 23 and 24 under 35 U.S.C.
§ 103(a) as obvious in view of Warburton, Gradl, and Leu, and further in
view of Biihren (claim 23) or Weaver (claim 24). Ans. 15—16. For these
rejections, Appellants argue that Biihren and Weaver do not cure the
deficiencies of Warburton, Gradl, and Leu in making obvious independent
claim 21. App. Br. 32. We affirm the rejections of claims 23 and 24.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
combination of Warburton, Gradl, and Leu would have made obvious an
intramedullary fixation member that comprises “a first pair of fastener
openings extending from the convex surface to the opposing concave surface
proximal to the first end of the elongate fixation member, the first pair of
fastener openings being oriented at different, divergent angles with respect
to each other” and “a third fastener opening extending through the guide
attachment surface and the convex surface at an angle that is substantially
perpendicular to the guide attachment surface,” as required by claim 21.
III.
The Examiner has rejected claim 25 under 35 U.S.C. § 103(a) as
obvious in view of Warburton, Gradl, Leu, Biihren, and Weaver. Ans. lb-
21. Claim 25 recites (emphasis added):
25. An intramedullary fixation member for use in repairing a distal
radius bone fracture, the distal radius having an articular surface,
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Application 11/948,189
comprising:
an elongate single-piece fixation member configured and sized for
insertion into the medullary canal of the distal radius, the fixation member
having opposed convex and concave surfaces, and opposed substantially
planar side surfaces extending between the convex and concave surfaces,
each of the convex, concave, and side surfaces extending between opposing
first and second longitudinal ends of the fixation member, each of the
convex and concave surfaces being arcuate between the first and second
longitudinal ends, with at least the convex and concave surfaces being
convergent toward the second longitudinal end, the second end configured
for placement within the medullary canal distal from the articular surface of
the distal radius;
the fixation member defining a first pair of fastener openings
extending from the convex surface to the opposing concave surface proximal
to the first end of the elongate fixation member, the first pair offastener
openings being oriented at different, divergent angles with respect to each
other,
the fixation member further defining a second pair of fastener
openings extending from a first one of the opposing side surfaces to a
second one of the opposing side surfaces and distal to the first pair of
fastener openings, and
at least one k-wire sized guide opening extending through the
opposing side surfaces;
the fixation member having a substantially planar guide attachment
surface about the first longitudinal end, with the first pair of fastener
openings being defined by the fixation member between the guide
attachment surface and the second pair of fastener openings, the guide
attachment surface extending from the concave surface away from the
second longitudinal end, the guide attachment surface defining a plurality of
indentations adapted for forming a positive fit with a plurality of prongs
extending from a mating surface of a guide assembly adapted for guiding
placement and fixation of the fixation member in the medullary canal; and
the fixation member defining a third fastener opening extending from
the guide attachment surface to the convex surface at an angle that is
substantially perpendicular to the guide attachment surface, the plurality of
indentations being spaced around the third fastener opening and cooperating
therewith to form a cruciform pattern, wherein the third fastener opening
comprises a first portion adjacent to the guide attachment surface and a
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second portion adjacent to the convex surface, the second portion being
lesser in lateral cross-sectional dimension than the first portion, and both
portions are threaded.
The issues: Does the evidence of record support the Examiner’s
conclusion that the combination of Warburton, Gradl, Leu, Biihren, and
Weaver would have made obvious an intramedullary fixation member that
comprises “a first pair of fastener openings extending from the convex
surface to the opposing concave surface proximal to the first end of the
elongate fixation member” and “a third fastener opening extending through
the guide attachment surface and the convex surface at an angle that is
substantially perpendicular to the guide attachment surface,” as required by
claim 25?
Analysis
For the rejection of claim 25, the Examiner relies on the combination
of Warburton, Gradl, and Leu as discussed above for claim 21. Ans. 16—19.
The Examiner further relies on Biihren as teaching “a fixation member 1
[that] defines a k-wire sized guide opening 7 extending between opposing
side surfaces, for the purpose of enabling insertion of the fixation member
by means of a guide wire.” Ans. 19, citing Biihren, col. 1,11. 49-51. The
Examiner also relies on Weaver as teaching “a fastener opening 36 . . .
[which is] conically tapered . . . [and] has a first portion and a second
narrower portion (figure 4) wherein both portions are threaded . . . [to]
provid[e] mating threads for a locking screw 20.” Ans. 19-20, citing
Weaver, col. 1,11. 45—60 and Fig. 4. The Examiner finds that Leu does not
disclose that “the indentations are in the form of a cruciform pattern . . .
[but] disclose[s] . . . a triangular pattern.” Ans. 17. The Examiner concludes
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that it would have been obvious to one of ordinary skill in the art “to include
a fourth indentation ... in the form of a cruciform pattern . . . [because the]
mere duplication of the essential working parts of a device involves only
routine skill in the art.” Ans. 20—21, citing St. Regis Paper Co. v. Bemis
Co., 549 F.2d 833 (7th Cir. 1977).
The Examiner concludes that it would have been obvious to one of
ordinary skill in the art, in view of Biihren, to modify Warburton’s fixation
“to include at least one k-wire sized guide opening . . . [to] enable [e]
insertion of the fixation member by means of a guide wire, thereby ensuring
proper placement and orientation of the fixation member.” Ans. 21, citing
Biihren, col. 1,11. 49—51. The Examiner concludes that it would have been
obvious to one of ordinary skill in the art, in view of Weaver, to modify
Warburton’s third opening to have first and second threaded portions “for
the purpose of providing locking mechanism between the screw and the
fixation device that provides high resistance to shear or torsional forces, in
order to prevent screw backout.” Ans. 21.
Appellants argue that Leu, Biihren, and Weaver “fail to cure the
deficiencies of Warburton and Gradl with respect to the claimed first pair of
fastener openings and the claimed third fastener opening.” App. Br. 39-40.
Appellants’ arguments are not persuasive. As discussed above, we
have concluded that the combination of Warburton and Gradl would have
made obvious an intramedullary fixation member with “a first pair of
fastener openings extending from the convex surface to the opposing
concave surface proximal to the first end of the elongate fixation member,
the first pair of fastener openings being oriented at different, divergent
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angles with respect to each other” and “a third fastener opening extending
from the guide attachment surface to the convex surface at an angle that is
substantially perpendicular to the guide attachment surface,” as required by
claim 25.
Thus, we affirm the rejection of claim 25 as being obvious in view of
Warburton, Gradl, Leu, Biihren, and Weaver.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
combination of Warburton, Gradl, Leu, Biihren, and Weaver would have
made obvious an intramedullary fixation member that comprises “a first pair
of fastener openings extending from the convex surface to the opposing
concave surface proximal to the first end of the elongate fixation member,
the first pair of fastener openings being oriented at different, divergent
angles with respect to each other” and “a third fastener opening extending
through the guide attachment surface and the convex surface at an angle that
is substantially perpendicular to the guide attachment surface,” as required
by claim 25.
SUMMARY
We affirm the rejections of claims 4—9, 11, 13, 15—21, 23—25, and 27
under 35 U.S.C. § 103(a).
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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).
AFFIRMED
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