Ex Parte Hershberger

Patent Trial and Appeal Board

Feb 23, 2017

12255945 (P.T.A.B. Feb. 23, 2017)

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.
12/255,945 10/22/2008 Troy W. Hershberger 5394.756US1 4278
104326 7590 02/27/2017
Schwegman Lundberg & Woessner / Zimmer
P.O. Box 2938
Minneapolis, MN 55402
EXAMINER
PENG, BO JOSEPH
ART UNIT PAPER NUMBER
3768
NOTIFICATION DATE DELIVERY MODE
02/27/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
SLW @ blackhillsip.com
USPTO@slwip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TROY W. HERSHBERGER1
Appeal 2015-005250
Application 12/255,945
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims that have
been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
Appellant’s invention “relates to magnetic resonance imaging (MRI),
computed tomography (CT) or fluoroscopy imaging and, more particularly,
1 Appellant identifies the Real Party in Interest as Biomet Manufacturing
Corp. (App. Br. 2.)
Appeal 2015-005250
Application 12/255,945
relates to mechanical axis alignment using MRI, CT, traditional x-ray scans
or fluoroscopy imaging.” (Spec. 11.)
Claims 17—23 and 26-41 are on appeal. Claim 17 is illustrative:
17. A method of imaging a knee joint of a leg before surgery
comprising:
locating an approximate center of a femoral head of the
leg;
locating an approximate center of an ankle joint of the leg;
locating an approximate center of a knee joint of the leg;
positioning a pivotal coupling member over the
approximate center of the knee joint of the leg, the pivotal
coupling member pivotally coupling a first and a second member
of a reference tool;
pivoting the first member of the reference tool relative to
the second member to position the first member over the
approximate center of the femoral head;
pivoting the second member of the reference tool relative
to the first member to position the second member over the
approximate center of the ankle joint; and
imaging the knee joint to produce an image of the knee
joint and at least a portion of the first and second members, the
at least a portion of the first member indicating a mechanical axis
of the leg in the image, and the at least a portion of the second
member indicating a tibial axis of the leg in the image, and
wherein the image includes the knee joint and excludes the
femoral head and the ankle joint.
(App. Br. 24 (Claims App’x).)
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Appeal 2015-005250
Application 12/255,945
The claims stand rejected as follows:
I. Claims 17—21, 26—28, 30, 32—34, 37, 38, 40, and 41 under
35 U.S.C. § 103(a) over Wehrli,2 Shoham,3 Riley,4 and Woolson ’975.5
II. Claims 22, 23, and 29 under 35 U.S.C. § 103(a) over Wehrli,
Shoham, Riley, Woolson ’975, and Huang.6
III. Claim 31 under 35 U.S.C. § 103(a) over Wehrli, Shoham,
Riley, Woolson ’975, and Lionberger.7
IV. Claim 35 under 35 U.S.C. § 103(a) over Wehrli, Shoham,
Riley, Woolson ’975, and Sugarman.8
V. Claim 36 under 35 U.S.C. § 103(a) over Wehrli, Shoham,
Riley, Woolson ’975, Lionberger, and Woolson ’936.9
VI. Claim 39 under 35 U.S.C. § 103(a) over Wehrli, Shoham,
Riley, Woolson ’975, and McFadden.10
DISCUSSION
REJECTIONS I-VI
These rejections rely upon the combination of Wehrli, Shoham, Riley,
and Woolson ’975, and so we focus on the Examiner’s findings with respect
to these references.
2 Wehrli, US 5,911,724, issued June 15, 1999.
3 Shoham et al., US 2007/0100258 Al, published May 3, 2007.
4 Riley et al., US 5,776,082, issued July 7, 1998.
5 Woolson, US 4,841,975, issued June 27, 1989.
6 Huang, US 2003/0074800 Al, published Apr. 24, 2003.
7 Lionberger et al., US 2005/0027303 Al, published Feb. 3, 2005.
8 Sugarman, US 4,428,571, issued Jan. 31, 1984.
9 Woolson, US 5,007,936, issued Apr. 16, 1991.
10 McFadden, US 5,560,728, issued Oct. 1, 1996.
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Application 12/255,945
Appellant’s independent claim 17 recites, among other things,
“pivoting the first member of the reference tool relative to the second
member to position the first member over the approximate center of the
femoral head,” “pivoting the second member of the reference tool relative to
the first member to position the second member over the approximate center
of the ankle joint,” and “imaging the knee joint to produce an image of the
knee joint. . . [that] includes the knee joint and excludes the femoral head
and the ankle joint.” Independent claims 26 and 32 recite similar
limitations. (App. Br. 24, 26, 28 (Claims App’x).)
The Examiner finds that
Wehrli ’724 teaches a method of imaging a knee joint of a leg
before surgery comprising: locating an approximate center of a
femoral head of the leg (Fig. 1, col. 19—32); locating an
approximate center of an ankle joint of the leg (col. 4, lines 11—
12); locating an approximate center of a knee joint of the leg (Fig.
1, col. 3, lines 39-54); positioning a pivotal coupling member
over the approximate center of the knee joint of the leg over the
skin of the knee joint (Fig. 1, col. 3, lines 39—54), the pivotal
coupling member pivotally coupling a first and a second member
of a reference tool (Fig. 1, element 26, 27, col. 4, lines 9-11);
pivoting the first member of the reference tool to position the first
member over the approximate center of the femoral head over
the patient’s skin (Fig. 1, col.4, lines 19—32); pivoting the second
member of the reference tool to position the second member over
the approximate center of the ankle joint over the patient’s skin
(col. 4, lines 11—12).
(Ans. 3.)
The Examiner finds that “Wehrli ’724 fails to teach the imaging of the
knee and the reference tool,” and that “Wehrli ’724 fails to teach pivoting
the first member of the reference tool relative to the second member of the
reference tool.” (Id.)
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Application 12/255,945
The Examiner turns to Riley and finds that it “teaches a method and
apparatus for making measurements of points on the human body including
pivoting one member relative to another member in order to measure body
parts [that] are not aligned in a straight line (Fig. 1, element 2 and 6, col. 5,
lines 28—58).” {Id. at 3 4.)
The Examiner also turns to Shoham and finds that it
teaches imaging the knee joint with a target device to produce an
image of the knee joint to indicate a mechanical axis of the leg in
the image and to indicate a tibial axis of the leg in the image,
wherein the image includes the knee joint and excludes the
femoral head and the ankle joint (Fig. 6A and 68, para 0073 —
para 0075, step 10).
{Id. at 4.)
The Examiner concludes that it would have been obvious to
modify the method of Wehrli ’724 to include the relative pivoting
arms of Riley ’082 and the imaging device of Shoham ’258 in
order to image both the knee and parts of the first and second
member of reference tool that is attached to the knee. One would
be motivated to make such a modification in order to accurately
identify each region of the knee, and its mechanical and tibial
axis with images of parts of first and second members of the
reference tool even when body parts are not aligned on the
straight line.
{Id.)
The Examiner also finds that “Woolson ’975 teaches preoperative
planning of bone cuts and joint replacement using radiant energy scan
imaging (title, and whole document, e.g. col. 5, lines 9-26).” {Id. at 5.)
The Examiner concludes that it would have been obvious to “modify the
method/device of Wehrli ’724 in view of Shoham ’258 and Riley ’082 to
include the preoperative planning features of Woolson ’975 in order to
ensure a surgical success.” {Id.)
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Application 12/255,945
A prima facie case of obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “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.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
We are not persuaded the Examiner has met the burden to establish by
a preponderance of the evidence that claims 17, 26, and 32 would have been
obvious. Instead, we agree with Appellant that, with respect to the Wehrli,
[adjustment of the pointers 26 and 27 directly causes adjustment
of the saw guide 25. The pointers 26 and 27 are fixed relative to
one another, and thus cannot be pivoted relative to one another,
which is in contrast to [Appellant’s] claimed first and second
members, which are pivotable relative to one another.
(App. Br. 12.) We further agree with Appellant that “[t]he Riley reference
fails to disclose or suggest positioning of a pivotable coupling member
relative to a leg and imaging the knee joint with the pivotal coupling
member in place as set forth in independent Claims 17, 26, and 32” {id. at
Br. 14), that “[t]he Shoham reference fails to disclose or suggest
[Appellant’s] pivotal coupling member, and claimed pivoting first and
second members thereof as claimed by [Appellant]” {id. at 15), and that
“[t]he Woolson reference fails to disclose or suggest [Appellant’s] claimed
pivotal coupling member and the methods of use set forth in independent
Claims 17, 26, and 32” {id.).
We recognize, but are not persuaded by, the Examiner’s assertion that,
in Wehrli,
pointer 26 and 27 are fastened by fastener 24 onto 23. Even
without pointer 26 and 27, Wehrli would work and [be] able to
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Application 12/255,945
cut but without the guide for the mechanical axes from pointer
26 and 27. The guide from the alignment of 26 and 27 which
represent the mechanical axes of the leg is used to guide the saw
guide for cutting. However as Riley has shown that leg cannot
always be straight then the alignment of straight pointer 26 and
27 need to be fine-tuned as to measure the actual mechanical
axes.
(Ans. 20.) We are further unpersuaded by the Examiner’s assertion that
one ordinary skill in the art can modify 24 of Wehrli by adding
pivoting 4a so that pointer 26 and 27 can pivot with another as
similar as the pivoting movement of 2 and 6 of Riley. Once the
actual mechanical axe is found then the fastener 24 and be
fastened to the saw guide for cutting.
{Id. at 21.) Instead, as Appellant explains,
[w]ith respect to the proposed combination of Wehrli and Riley
for example, the hip and tibia side pointers 26 and 27 of Wehrli
are suitable for their intended use, and there is no suggestion in
Wehrli or the art generally to make the pointers 26 and 27
individually pivotable relative to one another as [Appellant’s]
claimed first and second members are. Movement of the pointers
26 and 27 rotates the saw guide. If the pointers 26 and 27 were
made individually pivotable as suggested by the Examiner, then
one or both of the pointers 26 and 27 would be inoperable to
rotate the saw guide, thus rendering the Wehrli inoperable for its
intended use and making the proposed combination improper.
(App. Br. 16.) If the proposed modification would render the prior art
invention being modified unsatisfactory for its intended purpose, then there
is no suggestion or motivation to make the modification. In re Fritch, 972
F.2d 1260, 1266 n.12 (Fed. Cir. 1992) (citing In re Gordon, 733 F.2d 900,
902 (Fed. Cir. 1984)).
Further, “rejections 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
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Application 12/255,945
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). The
Examiner concludes that it would have been obvious to “add[] pivoting 4a
so that pointer 26 and 27 can pivot with another as similar as the pivoting
movement of 2 and 6 of Riley.” (Ans. 21.) The Examiner, however, did not
adequately explain how or why the skilled artisan would have predictably,
and with a reasonable expectation of success, modified the prior art in the
manner suggested. DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
567 F.3d 1314, 1326 (2009) (citations omitted) (“the ‘predictable result’
discussed in KSR refers not only to the expectation that prior art elements are
capable of being physically combined, but also that the combination would
have worked for its intended purpose.”) We thus agree with Appellant that
“[t]he proposed combination of the Wehrli, Shoham, Riley, and Woolson
references is improper because the Examiner is inappropriately relying on
speculation, unfound assumptions, hindsight reconstruction, and ‘common
knowledge without evidentiary support in the record.’” (App. Br. 15.)
On this record, the Examiner failed to establish an evidentiary basis to
support a conclusion that there was an advantage or reason to modify
Wehrli’s method to “pivot[] the first member of the reference tool relative to
the second member to position the first member over the approximate center
of the femoral head,” and to “pivot[] the second member of the reference
tool relative to the first member to position the second member over the
approximate center of the ankle joint” as required by claim 17, and similarly
required by claims 26 and 32.
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Application 12/255,945
We further recognize, but are not persuaded by, the Examiner’s
assertion that
Wehrli does not claim that having adding additional x-ray is
wrong. The device of Wehrli is intended to reduce the
inaccuracies associated with planning using x-ray photographs
when used without the device of Wehrli. Certainly the accuracy
would be improved with the device of Wehrli. . . . However,
there is NOTHING wrong to provide additional x-ray images
after the guide/device of Wehrli. . . has been put in place on the
leg in order to ensure the correct alignment of the guide and the
leg with an imaging device. Hence, when Shoham teaches
imaging the knee joint with a target device to produce an image
of the knee joint to indicate a mechanical axis of the leg in the
image and to indicate a tibial axis of the leg in the image, wherein
the image includes the knee joint and excludes the femoral head
and the ankle joint, Shoham is providing additional accuracy in
surgical planning.
(Ans. 21—22.) As Appellant explains,
[a]s for the proposed combination of Wehrli and Shoham, the
combination is improper because Wehrli teaches away from
using x-rays. For example, in the Background of the Invention
Section Wehrli explains that “planning using an x-ray
photograph contains some inevitable inaccuracies.” The device
of Wehrli is thus specifically designed and intended to be used
apart from x-rays, as set forth in the following exemplary excerpt
from Wehrli’s Summary of the Invention section for example:
“An object of the invention is to provide an instrument which
allows one to perform adjusting wedge-shaped osteotomies on a
lower extremity with high accuracy in which the result is
independent of inaccuracies associated with planning using x-
ray photographs[”]; “Thus, all of the variables determining the
operation are adjustable directly at the skeleton and are
examinable, and are therefore independent of planning, affected
by mistakes on the basis of x-ray photographs.” See col. 2, lines
60-64 and col. 3, lines 19-22 of Wehrli (emphasis added). The
Wehrli reference is thus suitable for use without the x-ray
analysis disclosed in Shoham, and specifically designed to be
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Application 12/255,945
used without x-rays. The Examiner’s proposed combination of
Wehrli and Shoham is improperly based on impermissible
hindsight speculation, and the prior art fails to suggest the
desirability of the modification.
(App. Br. 16—17.)
We are not persuaded that a skilled person would have been motivated
to modify Wehrli in the manner proposed by the Examiner to carry out the
particular positioning, pivoting, and imaging steps recited Appellant’s
claims. Among other things, Wehrli’s instrument is used to circumvent
inaccuracies arising from x-ray images. In addition, the Examiner has not
provided evidence or persuasive reasoning sufficient to show the skilled
artisan would have predictably performed imaging steps when an instrument
such as Wehrli’s is being used when Wehrli suggests such imaging is
unnecessary and unhelpful. The fact that other references (e.g., Shoham,
Woolson) teach imaging of the leg or knee joint incident to surgical
procedures, as contended by the Examiner, offers no apparent advantage in
the method suggested by Wehrli.
For the reasons above, the rejection of independent claims 17, 26, and
32 is reversed. The Examiner’s findings with respect to Huang, Lionberger,
Sugarman, Woolson ’936, and McFadden, do not make up for the
deficiencies of Wehrli, Shoham, Riley, and Woolson ’975. So too, we
reverse the rejections of claims 18—23, 27—31, and 33—41, which depend
directly or indirectly from claims 17, 27, and 32 respectively.
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Application 12/255,945
CONCLUSION OF LAW
We reverse the rejection of claims 17—21, 26—28, 30, 32—34, 37, 38,
40, and 41 under 35 U.S.C. § 103(a) over Wehrli, Shoham, Riley, and
Woolson ’975.
We reverse the rejection of claims 22, 23, and 29 under 35 U.S.C.
§ 103(a) over Wehrli, Shoham, Riley, Woolson ’975, and Huang.
We reverse the rejection of claim 31 under 35 U.S.C. § 103(a) over
Wehrli, Shoham, Riley, Woolson ’975, and Lionberger.
We reverse the rejection of 35 under 35 U.S.C. § 103(a) over Wehrli,
Shoham, Riley, Woolson ’975, and Sugarman.
We reverse the rejection of 36 under 35 U.S.C. § 103(a) over Wehrli,
Shoham, Riley, Woolson ’975, Lionberger, and Woolson ’936.
We reverse the rejection of 39 under 35 U.S.C. § 103(a) over Wehrli,
Shoham, Riley, Woolson ’975, and McFadden.
REVERSED
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