Ex Parte Burkus et al

Patent Trial and Appeal Board

Mar 20, 2013

11725618 (P.T.A.B. Mar. 20, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte J. KENNETH BURKUS, THOMAS A. ZDEBLICK,
THOMAS V. MCGAHAN, and STEVEN D. DERIDDER
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Appeal 2012-001564
Application 11/725,618
Technology Center 3700
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Before DONALD E. ADAMS, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 24-26 and 44-57
(App. Br. 2; Ans. 3). We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a device for inserting a spinal implant into a
spinal disc space. Claim 24 is representative and is reproduced in the
Claims Appendix of Appellants’ Brief.

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Claims 24-26, 44-46, 48-54, 56, and 57 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Steffee,1 Vich,2 and
Banko.3
Claims 47 and 554 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Steffee, Vich, Banko, and Winslow.5
We reverse the rejection of claims 45 and 53. We affirm all other
grounds of rejection.
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellants’ “invention relates generally to surgical procedures for
spinal stabilization and more specifically to instrumentation adapted for
inserting a spinal implant within the intervertebral disc space between
adjacent vertebra” (Spec. 1: 18-20).

1 Steffee, US 5,443,514, issued August 22, 1995.
2 Vich, US 4,877,020, issued October 31, 1989.
3 Banko, US 4,406,284, issued September 27, 1983.
4 We recognize that Examiner’s statement of the rejection refers to claims 47
and 53. Claim 53 relates to a driver sleeve comprising a hex nut (Claim 53).
Claim 47 relates to a shaft that “includes opposite flats adjacent a proximal
end of the shaft to provide an indication of an orientation of [the] pair of
fingers” (Claim 47). The language of claim 47 is the same as set forth in
claim 55 (see Claim 47; Cf. Claim 55). Therefore, Examiner’s reference to
claim 53 appears to be a typographical error as recognized by Appellants
(see Ans. 10; Cf. App. Br. 6 and 15).
5 Winslow, US 6,063,088, issued May 16, 2000. Examiner’s citation of
Winslow et al., US 6,083,225, issued July 4, 2000 is incorrect (see Ans. 4;
Cf. Ans. 10; App. Br. 15).
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FF 2. Steffee’s Figure 4 and Examiner’s annotation of Steffee’s Figure 7
are reproduced below:

“FIG. 4 is a sectional view of an instrument for holding [a] … spinal
implant … to facilitate inserting the spinal implant between adjacent
vertebrae and rotating the spinal implant” (Steffee, col. 1, ll. 59-62). “FIG.
7 is a sectional view of a clamp portion of the instrument of FIG. 4” (id. at ll.
67-68; Ans. 11).
FF 3. Examiner finds that Steffee’s device, an implant holder (80) that is
moveable to engage and disengage the spinal implant, comprises: (a) a shaft
(84 and 86) having (i) a threaded portion (120) and (ii) a tapered portion
(132) that increases in size towards a distal end of the shaft; (b) an implant
engaging portion (86) at a distal end of the shaft; and (c) a driver sleeve (82)
having a hollow interior (Ans. 5).
FF 4. Examiner finds that the implant engaging portion (86) of Steffee’s
device comprises: (a) a distal end wall forming a recess and (b) a pair of
fingers (136) extending distally from opposite sides of the distal end wall
(id.).
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FF 5. Examiner finds that Steffee’s device comprises a slit that extends
proximally from the distal end wall along a center axis of the shaft that is
narrowed as the implant holder is moved to an engaged position (id. (“[A]s
the extensions are ‘clamped’ the slit will close/narrow in size/dimension due
to the clamping force created between surfaces”)).
FF 6. Examiner finds that Steffee fails to suggest (1) “a slit extending
through … [the] distal end wall separating … the pair of projections from
one another” or (2) a “driver sleeve being threadingly engaged to the shaft”
(id. at 6).
FF 7. Vich’s Figures 1-3 are reproduced below:

[T]he instrument 10 of [Vich’s] FIGS. 1-3, … includes a
substantially cylindrical sleeve-like holding head 11 which is
secured to one end of an elongated rodlike handle 12, the latter
having at least the upper portion of the periphery thereof
serrated or roughened at 13 to facilitate gripping thereof. The
head 11 is interchangeably attached to the handle, as by a
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threaded connection 6, so that the head can be interchanged to
permit selection of a head having a diameter or size
corresponding to the diameter of the graft. This head 11 has a
central opening 14 extending coaxially therethrough and
aligned with a further opening or bore 15 which extends
coaxially through the handle 12. Head 11, at the lower or
frontal end thereof, has two small but elongated pins 16
projecting axially outwardly therefrom, which pins taper to a
point and are disposed closely adjacent the bore 14 on
substantially diametrically opposite sides thereof. An elongated
rod 17 extends through and is rotatable relative to the aligned
bores 14-15, which rod 17 at the lower end thereof is provided
with a projecting threaded portion or screw 18 which projects
through the holding head 11. Rod 17, at the upper end thereof,
has a threaded part 19 of enlarged diameter which is threadably
engaged with a threaded bore 9 which is formed in and opens
coaxially upwardly through the upper end of the handle 12. An
enlarged gripping knob 8 is fixedly secured to the upper end of
this rod 17 and is positioned adjacent the upper free end of the
handle 12 so as to be readily accessible.
(Vich, col. 2, ll. 33-61.)
FF 8. Examiner finds that Vich’s device comprises (1) “a pair of
projections (16, figures 1-3) extending distally from a distal end wall with a
slit 14, figure 3) extending through said distal end wall separating the pair of
projection from one another to securely hold the implant” and (2) a “driver
sleeve (12, figures 1-3) threadingly engaged (9, figure 2 and 19, figure 2) to
the shaft permitting fine tuned adjustment of the shaft length within the
driver sleeve” (Ans. 6).
FF 9. Examiner finds that Steffee fails to suggest a “plastic bushing on a
distal end of the driver sleeve in contact with the tapered portion” and relies
on Banko to make up for this deficiency in Steffee (id. at 7).
FF 10. Examiner finds that “Steffee discloses the claimed invention except
for the disclosure of a hex nut on a proximal end of the driver sleeve” (id.).
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FF 11. Examiner finds that the combination of Steffee, Banko, and Vich
fails to suggest a “shaft including opposite flats adjacent a proximal end of
the shaft” (id. at 10).
FF 12. Winslow’s Figure 1 is reproduced below:

Winslow’s “FIG. 1 is a perspective view of the surgical retractor utilized in
distracting adjacent bony structures and the surgical drilling instrument
utilized in drilling a bore within the adjacent bony structure in accordance
with the principles of … [Winslow’s] disclosure” (Winslow, col. 4, ll. 31-
36).
FF 13. Examiner finds that Winslow suggests “multiple oppositely facing
flats (hexagonal shaped head) … to … provide an indication of an
orientation of the pair of fingers” (id. at 14).
ANALYSIS
Based on the combination of Steffee, Vich, and Banko, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious to “construct[] the implant engaging portion of
Steffee to include a pair of projections extending distally from the distal end
wall to securely hold the implant” and place “threading on the driver sleeve
engaging threading on the shaft of the device to permit fine tuned
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adjustment[s] … of the shaft length within the driver sleeve as …
[suggested] by Vich” (Ans. 6-7). Examiner also finds that
it would have been obvious to one of ordinary skill in this art at
the time the invention was made to … construct[] the driver
sleeve of Vich to include a plastic bushing as taught by Banko
to reduce the coefficient of friction between the two members
thereby making manipulation of the driver sleeve and implant
holder easier on the surgeon.
(id. at 7.)
Claim 24:
Appellants contend that “it would require a substantial redesign of
Steffee’s instrument to provide threaded engagement between handle 84 and
intermediate portion 82 while also allowing handle 84 to be threaded into
clamp portion 86 to draw clamp portion 86 into intermediate portion 82 to
clamp the implant between extensions 136” (App. Br. 11). We are not
persuaded. Appellants fail to provide persuasive evidence or argument to
support a conclusion that the addition of “threading on the driver sleeve
engaging threading on the shaft of the device to permit fine tuned
adjustment[s] … of the shaft length within the driver sleeve” as suggested by
Vich, represents more than “[t]he combination of familiar elements
according to known methods” or a substantial redesign of Steffee’s device
(FF 2, 7, and 8). See, KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007).
We are also not persuaded by Appellants’ unsupported contention that
“[e]ven if threaded engagement between intermediate portion 82 and handle
84 could be added to Steffee, the axially penetrating pins 16[, suggested by
Vich] that extend into the graft as handle 84 is threadedly adjusted relative to
the intermediate portion 82 would prevent clamp halves 130 of Steffee from
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being closed to clamp the implant therebetween” (App. Br. 11). As
Examiner explains “the addition of pin[s] like those of Vich to the distal end
wall [of Steffee’s device] would not prevent the clamp halves from being
moved toward or away from one another, but rather the pins can operate to
do the initial holding of the implant during the clamping process” or “even
improve the clamping of [Steffee’s] halves 130 to the implant if they are
oriented in the same direction as the clamping” (Ans. 13). Appellants fail to
provide persuasive evidence or argument to rebut Examiner’s prima facie
case. Accordingly, we are not persuaded by Appellants’ contention that the
combination of Steffee and Vich “would require a substantial redesign of
Steffee that would change Steffee’s basic side clamping principle of
operation” (App. Br. 11). Further, we note that “a person of ordinary skill is
also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at
421. Therefore, we are not persuaded by Appellants’ contention that Vich
fails to suggest
pins that extend toward one another, and in fact … teaches
away from [orienting pins 16 in the clamping direction
suggested by Steffee] since orienting the pins to penetrate the
sides of the graft would prevent [Vich’s] screw 18 from being
moved axially relative to the graft to engage the graft.
(App. Br. 13.) Appellants’ contention fails to appreciate that Examiner’s
rejection did not propose inserting Vich’s screw 18 into Steffee’s clamping
structure. In re Keller, 642 F.2d 413, 425 (CCPA 1981) (“The test for
obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference…. Rather,
the test is what the combined teachings of the references would have
suggested to those of ordinary skill in the art.”).

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Claims 45 and 53:
Examiner reasons that while Steffee does not disclose “a hex nut on a
proximal end of the driver sleeve. It would have been an obvious matter of
design choice to provide the driver sleeve with a hex nut on the proximal
end” (Ans. 7; see FF 10). Appellants contend that “[s]ince there is no reason
articulated in the final Office Action to provide sleeve 82 with a hex nut on
its proximal end, the references do not teach claim[] 45” (App. Br. 14). We
agree. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[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.”). Examiner
failed to articulate a reason why a person of ordinary skill in this art would
have placed a hex nut on the proximal end of the driver sleeve.

Claim 47:
Based on the combination of Steffee, Vich, Banko, and Winslow,
Examiner concludes that, at the time Appellants’ invention was made, it
would have been prima facie obvious “to include opposite flats adjacent the
proximal end of the shaft as … [suggested] by Winslow” to provide an
indication of an orientation of Steffee’s fingers (Ans. 11).
Appellants contend that “the orientation of [Winslow’s] spinals [sic,
splines] 216 [are] fixed and there is no reason for the surgeon to employ the
hexagonal head as a reference point to know where splines 216 lie in a
patient” (App. Br. 15). We are not persuaded. As Examiner explains, the
opposite flats adjacent a proximal end of the shaft of a device, such as those
suggested by Winslow could be used by a surgeon “as a reference point …
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[to] know where the two finger portions lie when inside the patient” (Ans.
14). We find no error in Examiner’s reasoning. Appellants fail to provide
persuasive evidence or reasoning to rebut Examiner’s prima facie case.
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness with regard to claim 24. The rejection of claim 24 under 35
U.S.C. § 103(a) as unpatentable over the combination of Steffee, Vich, and
Banko is affirmed. Claims 25, 26, 44, 46, 48-52, 54, 56, and 57 are not
separately argued and fall with claim 24.
The preponderance of evidence on this record fails to support a
conclusion of obviousness with regard to claims 45 and 53. The rejection of
claims 45 and 53 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Steffee, Vich, and Banko is reversed.
The preponderance of evidence on this record supports a conclusion
of obviousness with regard to claim 47. The rejection of claim 47 under 35
U.S.C. § 103(a) as unpatentable over the combination of Steffee, Vich,
Banko, and Winslow is affirmed. Claim 55 is not separately argued and falls
with claim 47.
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-IN-PART

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