Ex Parte McGraw et al

Board of Patent Appeals and Interferences

Jun 14, 2012

11327515 (B.P.A.I. Jun. 14, 2012)

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.
11/327,515 01/09/2006 J. Kevin McGraw HATCH-005-CIP 2476
21884 7590 06/14/2012
WELSH FLAXMAN & GITLER LLC
2000 DUKE STREET, SUITE 100
ALEXANDRIA, VA 22314
EXAMINER
CARTER, TARA ROSE E
ART UNIT PAPER NUMBER
3733
MAIL DATE DELIVERY MODE
06/14/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte J. KEVIN McGRAW and DIRK V. HOYNS
__________

Appeal 2011-005362
Application 11/327,515
Technology Center 3700
__________

Before ERIC GRIMES, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to a stabilization device for use in percutaneous stabilization
of adjacent vertebrae. The Patent Examiner rejected the claims for
obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
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STATEMENT OF THE CASE
Claims 1, 2, 4-13, and 15-25 are on appeal. Claim 1 is representative
and reads as follows:
1. A stabilization device for use with a system for the percutaneous
stabilization of adjacent vertebrae, the stabilization device comprising:
an elongated stabilization device body made of a shape memory or
super elastic material which is substantially straight prior to deployment and
takes a desired curved configuration upon entering the vertebrae;
the stabilization device body assuming a radius of curvature upon
entering the vertebrae, the radius of curvature being between 3cm and 6cm
and, encompassing an arc of 60° to 110°, the stabilization device further
including a leading end and a trailing end, wherein the trailing end includes
a keying element for ensuring proper orientation of the stabilization device
during insertion,
the stabilization device further includes rings, holes or barbs adjacent
the trailing end and leading end for fixation with the vertebral body.

The Examiner rejected the claims as follows:
 claims 1, 2, 4, 7, 9-13, 15, 16, 18-20, 22, 23, and 25 under 35 U.S.C.
§ 103(a) as unpatentable over Keith,1 Carl,2 and Romano;3
 claims 17 and 21 under 35 U.S.C. § 103(a) as unpatentable over
Keith, Carl, Romano, and Jackson;4
 claim 8 under 35 U.S.C. § 103(a) as unpatentable over Keith, Carl,
Romano, and Grafton;5
 claim 24 under 35 U.S.C. § 103(a) as unpatentable over Keith, Carl,
Romano, Grafton, and Fontenot;6 and

1 Peter T. Keith et al., US 6,579,291 B1, June 17, 2003.
2 Allen Carl et al., US 6,607,530 B1, August 19, 2003.
3 Jack W. Romano, US 4,941,466, July 17, 1990.
4 Roger P. Jackson, US 6,258,090 B1, July 10, 2001.
5 R. Donald Grafton, US 2001/0051807 A1, Dec. 13, 2001.
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 claims 1, 5, and 6 under 35 U.S.C. § 103(a) as unpatentable over
Steffee,7 Carl, and Romano.

OBVIOUSNESS
A. The rejections over Keith, Carl, and Romano
The Issues
The rejection states that “Keith teaches the claimed invention except
for wherein the trailing end includes a keying element; the radius of
curvature being between 3-6 cm and encompassing an arc of 60-110
degrees; the stabilization device further including rings, holes or barbs
adjacent the trailing end and leading end for fixation with the vertebral
body.” (Ans. 4.) The rejection states that “Carl teaches a keying element
adapted for engagement with a keying element at the trailing end of the
stabilizing device (see figs. 8a-8b); the radius of curvature being between
3-6cm and encompassing an arc (fig. 6A and col. 11 lines 49-62) that
corresponds to the curved bore in the bone; the stabilization device further
including rings, holes or barbs adjacent the trailing end and leading end for
fixation with the vertebral body (col. 11 line 62- col. 12 line 15 and fig. 6A)
in order to orient the stabilization device into the vertebral body correctly
while providing the desired fixation.” (Id. at 4-5.)
Based on those findings, the rejection states: “It would have been
obvious to one of ordinary skill in the art at the time the invention was made
to modify the trailing end of Keith with the trai[l]ing end in view of Carl in
order to orient the stabilization device through a vertebral body. (Id. at 4-5.)

6 Mark G. Fontenot, US 5,639,237, June 17, 1997.
7 Arthur D. Steffee, US 4,790,303, Dec. 13, 1988.
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The rejection states that “Keith and Carl do not appear to specifically
teach the range of the arc” (id. at 5), but, based on Romano’s disclosure of a
curved bore in bone, wherein the bore is disposed at approximately 180
degrees, the rejection states that “it would have been obvious to one having
ordinary skill in the art at the time the invention was made to try an implant
with an arc (and also a corresponding bore) to be within the range of 60-110
degrees as a mere design consideration. Also, it has been held that where the
general conditions of a claim are disclosed in the prior art, discovering the
optimum or workable ranges involves only routine skill in the art. In re
Aller, 105 USPQ 233.” (Id. at 5-6.)
Appellants contend that “it is readily apparent that [the Keith and Carl
patents] relate to very different medical procedures.” (App. Br. 13.) “While
Carl desires to fix adjacent vertebrae, Keith is concerned with reinforcing a
single damaged vertebral disc.” (Id.) According to Appellants, “[i]t is not
enough that one simply find elements within devices in the medical area to
create an obviousness rejection,” and “there is no reason for combining the
teachings of Carl with Keith.” (Id.)

Discussion
The rejection found that Keith “teaches the claimed invention except
for” three listed differences. The evidence does not support the finding of
only three differences. As Appellants argue, another difference is that
Keith’s stabilization device is inserted into a disc, not into vertebrae. We
agree with Appellants that the rejection did not resolve this difference by
explaining why the teachings of Keith and Carl would have been combined.
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The “Response to Argument” finds Appellants’ point unpersuasive on the
ground that “the test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the structure of the
primary reference.” (Ans. 15.) However, “bodily incorporation” is what the
rejection under review proposed (“modify the trailing end of Keith with the
trai[l]ing end in view of Carl” (Ans. 4-5)); and the rejection must therefore
stand or fall on the soundness of that proposal. The rejection made an error
of fact in overlooking a difference between the use Keith’s device serves,
and the use served by Carl’s and Appellants’ devices, and it did not explain
how a person of ordinary skill in the art would have resolved this difference.
The rejection’s reliance on Romano concerned other aspects of the invention
and did not remedy this error. Accordingly, the rejections based on the
combination of Keith and Carl must be reversed.

B. The rejection over Steffee, Carl, and Romano
The Issues
The rejection states that Steffee teaches a stabilization device for use
with a system for the percutaneous stabilization of adjacent vertebrae. (Ans.
11.) The rejection found these differences between Steffee’s device and the
claimed device:
Steffee does not state the elongated stabilization device is made
of a shape memory or super elastic material which is substantially
straight prior to deployment and takes a desired curvature upon
entering the vertebrae and wherein the trailing end includes a keying
element; the radius of curvature being between 3-6cm and
encompassing an arc of 60-110 degrees; the stabilization device
further including rings, holes or barbs adjacent the trailing end and
leading end for fixation with the vertebral body.

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(Id. at 12.) The rejection found most of these features taught by Carl’s
stabilization device, also used with a system for stabilizing adjacent
vertebrae, and concluded that it would have been obvious to modify
Steffee’s device with the features of Carl’s device. (Id. at 13.)
The rejection states that “Steffee and Carl do not appear to
specifically teach the range of the arc” (id.), but, based on Romano’s
disclosure of a curved bore in bone, wherein the bore is disposed at
approximately 180 degrees, the rejection states that “it would have been
obvious to one having ordinary skill in the art at the time the invention was
made to try an implant with an arc (and also a corresponding bore) to be
within the range of 60-110 degrees as a mere design consideration. Also, it
has been held that where the general conditions of a claim are disclosed in
the prior art, discovering the optimum or workable ranges involves only
routine skill in the art. In re Aller, 105 USPQ 233.” (Id. at 14.)
Appellants contend that the radius of curvature between 3cm and 6cm
and arc of 60° to 110° are critical to proper positioning of the stabilization
device, but Steffee and Carl fail to disclose them “as neither of these devices
is concerned with the methodology contemplated and disclosed in
accordance with the present invention.” (App. Br. 19.) According to
Appellants, “there is no reason for applying the teachings of Romano to the
device of Steffee in view of Carl in a manner rendering the claimed
invention obvious.” (Id. at 20.) “While Romano does disclose an apparatus
for creating curved bores in bone, Romano most certainly does not teach one
employing a bone grafting system such as disclosed by Steffee to modify the
fastener of Steffe[e] with a radius of curvature between 3cm and 6cm and
encompass an arc of 60° to 110°.” (Id.)
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Appellants contend that the rejection misses the point of, and errs in
its reliance on, In re Aller, and ask “Considering the fact Steffee, Carl and
Romano fail to teach the basics of the claimed invention, why would one of
ordinary skill in the art optimize Steffee, Carl and Romano so as to render
the claimed invention obvious?” (Id. at 20.)
Appellants query why one of skill in the art would have applied Carl’s
shape memory or super elastic material to Steffee’s device, said to be a
preformed shank that must be driven into a pair of bone portions, and query
whether Carl’s materials would offer a benefit to Steffee’s device. (Id.)
According to Appellants, neither reference supports the proposed
replacement, and nor would the common sense of those of ordinary skill in
the art. (Id.)
Appellants also contend that there would have been no reason to apply
Carl’s keying element to Steffee’s device because their insertion processes
are “entirely different.” (Id. at 21-22.)

Discussion
We discuss Appellants’ issues in turn.
First, we agree with the Examiner that the radius of curvature between
3cm and 6cm and arc of 60° to 110° would have been obvious adjustments
to Steffee’s device in view of Carl and Romano. The Examiner cited Carl’s
express disclosure that “[t]he implant also preferably should have an
appropriate radius of curvature such that both vertebrae are engaged while
staying well clear of the spinal cord. That radius preferably is about 1.5
inches, as referenced from the arcuate implant's inner radius.” (Carl, col. 11,
ll. 58-62.) We see no error in the Examiner’s finding that the suggested 1.5
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inch radius of curvature is a value between 3cm and 6cm, because 1.5 inch is
equivalent to 3.8cm. The Examiner relied on Romano as evidence that
arcuate distances up to 180° could be drilled into bone if desired.
Adjustment of the actual length of Steffee and Carl type devices to fit an
actual patient would have necessarily been decided on a patient-by-patient
basis. We agree with the Examiner that this is the kind of adjustment that
would have been obvious to optimize to whatever length would fit the
patient, and that the rejection’s citation to In re Aller, 220 F.2d 454, 456
(CCPA 1955) was appropriate. Appellants seem to argue that because 60°
to 110° is specifically recited, this length is therefore critical. We agree with
the Examiner that Appellants offer no showing of criticality outweighing the
obviousness of routine adjustment to fit a patient. Finally, because all three
references are in the field of orthopedic surgery and address related, if not
the same (Steffee and Carl) problems, a person of ordinary skill in the art
would have found their teachings on radius of curvature and arc length
reasonably applicable to each other. We therefore reject Appellants’
contention that because the three references address the problem in
nonidentical ways all their teachings must be treated as unrelated.
Second, Appellants contend that because Steffee’s device is driven
into bone, and Carl’s device is inserted into a pre-drilled hole, there is no
evidence of a benefit to using Carl’s shape memory material for Steffee’s
device. The rejection found that Steffee’s device was not made of shape
memory material, was not straight before deployment, and did not take a
desired curvature upon entering the vertebrae, and found that Carl’s device
was made of shape memory material, was straight before deployment, and
took a desired curvature upon entering the vertebrae. However, the rejection
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did not expressly state that it would have been obvious to replace Steffee’s
material with Carl’s, nor did it state a reason why it would have been
obvious to do so. (See Ans. 12-13.) The Examiner responds to Appellants’
arguments about the lack of reason or motivation for using Carl’s shape
memory material in Steffee’s device by stating: “Appellant actually agrees
that such a material is well known in the art.” (Ans. 17.) The response is
unpersuasive. An invention “composed of several elements is not proved
obvious merely by demonstrating that each of its elements was,
independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 418 (2007). Instead, a rejection for obviousness must include
“articulated reasoning with some rational underpinning to support the legal
conclusion.” Id., quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
As the rejection failed to provide a rationale to support its conclusion
regarding shape memory material, it must be reversed.
As the rejection is reversed, it is unnecessary to discuss Appellants’
keying element argument.

SUMMARY
We reverse the rejection of claims 1, 2, 4, 7, 9-13, 15, 16, 18-20, 22,
23, and 25 under 35 U.S.C. § 103(a) as unpatentable over Keith, Carl, and
Romano.
We reverse the rejection of claims 17 and 21 under 35 U.S.C. § 103(a)
as unpatentable over Keith, Carl, Romano, and Jackson.
We reverse the rejection of claim 8 under 35 U.S.C. § 103(a) as
unpatentable over Keith, Carl, Romano, and Grafton.
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We reverse the rejection of claim 24 under 35 U.S.C. § 103(a) as
unpatentable over Keith, Carl, Romano, Grafton, and Fontenot.
We reverse the rejection of claims 1, 5, and 6 under 35 U.S.C.
§ 103(a) as unpatentable over Steffee, Carl, and Romano.

REVERSED

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