Ex Parte Meridew et al

Patent Trial and Appeal Board

Sep 7, 2018

13041883 (P.T.A.B. Sep. 7, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/041,883 03/07/2011
104326 7590 09/13/2018
Schwegman Lundberg & Woessner/ Zimmer
P.O. Box 2938
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Jason D. Meridew
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
5394.701US 1 5918
EXAMINER
NELSON, CHRISTINE L
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
09/13/2018 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 JASON D. MERIDEW, TONY SIEBENECK, and
ROBERT METZGER1
Appeal2017-007969
Application 13/041,883
Technology Center 3700
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a medical device for preparing
an elongated bone for receiving an implant. The Examiner rejected the
claims as anticipated under 35 U.S.C. § 102 and as obvious under 35 U.S.C.
§ 103. Appellants appeal the rejection pursuant to 35 U.S.C. § 134(a). We
have jurisdiction under 35 U.S.C. § 6(b ). The rejections are affirmed-in-
part.
STATEMENT OF THE CASE
As set forth in the Examiner's Answer dated March 8, 2017 ("Ans."),
the claims stand rejected as follows:
1 The Appeal Brief ("Appeal Br.") 2 lists Biomet Manufacturing, LLC, as
the real party in interest.
Appeal2017-007969
Application 13/041,883
Claims 1, 2, 4--7, 13, 14, 28, 32-34, and 36-38 underpre-AIA 35
U.S.C. § I02(b) as anticipated by Gjerde (U.S. Publ. Pat. Appl.
2008/0234685 Al, published Sept. 25, 2008). Ans. 3.
Claims 3 and 35 under pre-AIA 35 U.S.C. § I03(a) as obvious in view
of Gjerde and Sanders et al. (U.S. Pat. No. 5,578,037, issued Nov. 26, 1996).
Ans. 6.
Claims 9-11, 16, 17, and 29-31 under pre-AIA 35 U.S.C. § I03(a) as
obvious in view of Gjerde and White et al. (U.S. Publ. Pat. Appl.
2009/0254093 Al, published Oct. 8, 2009). Ans. 6.
There are three independent claims, claims 1, 13, and 2 8, which are all
rejected as anticipated by Gjerde. Appellants only provided arguments for
the anticipation rejection based on Gjerde, but not the two § 103 rejections,
asserting "that neither Sanders nor White [ cited in the § 103 rejections]
address the ... deficiencies of Gjerde. Appeal Br. 19. Thus, the § 103
rejections, which involve dependent claims only, stand or fall with the
independent claims on which they depend.
All three independent claims have a different scope, and are addressed
separately below. The anticipation and obviousness rejections are addressed
under the separate headings for each independent claim.
REJECTIONS BASED ON GJERDE
Claim 1
Claim 1 is reproduced below:
1. A medical device for preparing an elongated bone for
receiving an implant comprising:
a femoral guide having a patient-specific three-
dimensional bone-engaging surface configured according to a
preoperative plan based on a three-dimensional image model of
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Appeal2017-007969
Application 13/041,883
a proximal femoral bone to mate complementarily with the
surface of the proximal femoral bone extending between a
greater trochanter, a femoral neck and a femoral shaft of the
proximal femoral bone, the femoral guide including a first
guide end forming a planar guide configured to engage a
resection tool within a desired resection plane and thereby
guide the resection tool as the resection tool cuts the femoral
neck along the desired resection plane and completely removes
a femoral head of the proximal femoral bone but preserves the
greater trochanter; and
an elongated alignment member removably attachable to
the femoral guide and defining a reference axis for guiding a
cutting tool into the proximal femoral bone through a resected
surface of the femoral neck.
The Examiner found that Gjerde describes all the limitations of the
claimed "medical device for preparing an elongated bone for receiving an
implant." Final Act. 3--4. Appellants contend that Gjerde does not describe
"a femoral guide having a patient-specific three-dimensional bone-engaging
surface"
including a first guide end forming a planar guide configured to
engage a resection tool within a desired resection plane and
thereby guide the resection tool as the resection tool cuts the
femoral neck along the desired resection plane and completely
removes a femoral head of the proximal femoral bone but
preserves the greater trochanter
Appeal Br. 13 ( quoting from claim 1 ( emphasis added)). Specifically,
Appellants contend that, when the device is installed on the bone and the
"planar guide end" is used to guide the resection tool along the "desired
resection plane," at least a portion of the greater trochanter is removed along
with other portions of the proximal femur. Id. at 12-13. Appellants assert
that Figure 1 of Gjerde shows that the Gjerde device removes the trochanter.
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Application 13/041,883
Id. at 12. Appellants assert that the claim, on the other hand, requires the
trochanter to be "preserved." Id. at 13.
The Examiner acknowledges that Figure 1 of Gjerde shows that the
device removes a part of the greater trochanter, but the Examiner found that
Figure 1 shows that a part of the greater trochanter is preserved at the same
time. Ans. 6. The Examiner states that the Specification does not define
"preserve" to mean preserving "'the entire greater trochanter"', and that
"therefore determining the scope of 'preserve' is open for broad
interpretation." Id.
Discussion
It is undisputed that Figure 1 of Gjerde shows that a portion of the
greater trochanter is removed, such that entire trochanter is not preserved.
Thus, the issue in this rejection is whether the phrase "preserves the greater
trochanter" means that the complete greater trochanter must be preserved.
We therefore must begin with claim interpretation.
During patent examination proceedings, claim terms are given "the
broadest reasonable meaning ... in their ordinary usage as they would be
understood by one of ordinary skill in the art, taking into account whatever
enlightenment by way of definitions or otherwise that may be afforded by
the written description contained in the applicant's specification." In re
Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). Thus, we first look to the
Specification for guidance as to the claim's meaning.
The Specification does not provide a definition of "preserves the
greater trochanter." However, as indicated by Appellants, the only
embodiment in the Specification of a device for transecting the femur is one
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Appeal2017-007969
Application 13/041,883
in which the femoral head is removed, sparing the greater trochanter.
Figure 1 of Specification, illustrating this embodiment, is reproduced below
(annotations added):
A
I:![;\:;:, _I -,
102JL
With respect to Figure 1, reproduced above, the Specification
explains:
With the femoral guide 100 secured on the proximal femur 80,
a cutting blade or saw or other surgical instrument can be
guided by the first guide end 104 to cut the femoral neck 84
along a resection plane R, thereby removing the femoral head
86 and exposing the resected surface 88 of the femoral neck 84,
as shown in FIGS. 1 and 2.
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Appeal2017-007969
Application 13/041,883
Spec. ,r 29.
Figure 1 thus shows guide end 104 providing a resection plane R,
which cuts into the femoral neck 84 and removes the femoral head 86 of the
femur without cutting along the greater trochanter 82. The greater
trochanter 82 is completely spared during the resection of the femur,
consistent with the definition of "preserve" to mean "to keep ... intact. "2
While "a particular embodiment appearing in the written description
may not be read into a claim when the claim language is broader than the
embodiment" (SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870,
875 (Fed. Cir. 2004)), in this case the claim expressly states that the greater
trochanter is "preserve[ d]," indicating that it is kept intact when the claimed
"guide end" is used to guide the resection tool to resect the femoral neck.
The Examiner's interpretation of the disputed phrase did not properly
consider the ordinary meaning of the term "preserve" to mean "to keep ...
intact," consistent with the embodiment shown in Figure 1.
Because the device described by Gjerde does not have a guide end
"configured to engage a resection tool within a desired resection plane and
thereby guide the resection tool as the resection tool cuts the femoral neck
along the desired resection plane and completely removes a femoral head of
the proximal femoral bone but preserves the greater trochanter" as required
by independent claim 1, we are compelled to reverse the rejection of claim 1.
Dependent claims 2-7 and 9-11 are reversed as well for the same reasons
2 "1 : to keep safe from injury, harm, or destruction : protect
2 a : to keep alive, intact, or free from decay
b : maintain" (https://www.merriam-webster.com/ dictionary/preserve)
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Appeal2017-007969
Application 13/041,883
and because the Examiner did not cite White as meeting the deficiency we
found in Gjerde.
Claim 13
Independent claim 13 is directed to "[a] medical device for preparing
a proximal femoral bone for an implant" comprising a femoral guide, a
cutting tool, a driver tool, an elongated alignment member, and a connector
"slidably couplable" to the alignment member. Unlike independent claim 1,
claim 13 does not require the greater trochanter to be preserved upon
resection.
Claim 13 comprises "a driver tool for holding and driving the cutting
tool into the femoral bone along a first axis", "an elongated alignment
member attachable to the femoral guide and extending along a second axis";
and "a connector slidably couplable to the alignment member and to the
driver tool and having a patient-specific distance between the first and
second axes for guiding the cutting tool into the femoral bone" ( emphasis
added). The Examiner found these limitations to have been met by Gjerde.
Appellants contend that the osteotomy template 28 of Gjerde, which
the Examiner found to comprise a connector,
does not disclose the connector has "a patient-specific distance
between the first and second axes for guiding the cutting tool
into the femoral bone through a resected surface of the femoral
neck at a position determined during a preoperative plan based
on the three-dimensional image model of the femoral bone" as
recited in claim 13. Indeed, to the best of Appellants'
understanding, there is no disclosure of use of a patient-specific
distance for a connector ( or any item for that matter) in Gjerde.
Appeal Br. 1 7.
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Appeal2017-007969
Application 13/041,883
Discussion
As expressly found by the Examiner, Gjerde teaches that the
osteotomy template is patient-specific. Final Act. 3. The following
disclosure is cited by the Examiner to support this finding:
The osteotomy template is preferably patient-adapted, an
osteotomy template being provided for each patient that is
adapted in size and shape to the patient's femur and the cutting
plane being determined for each osteotomy template on the
basis of the individual patient's femur. By this means greater
precision is obtained in the resection for each patient.
Gjerde ,r 13.
The adaptation of size and shape is undertaken on the basis of a
3-dimensional model which, for example, may be provided by
means of CT images.
Gjerde ,r 14.
Thus, the Examiner's determination that the "patient-specific" aspect
of claim 13 is met by Gjerde is supported by a preponderance of the
evidence.
The Examiner cited Figure 3 of Gjerde as disclosing all the features of
claim 13. Figure 3 of Gjerde is reproduced below, with annotations added to
show the axes and the elements of the claim:
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Appeal2017-007969
Application 13/041,883
Fig.3
;:;:
1rnrr::.::::6
----:~.~! \l
\ ~i ... · ·\'--........_ d.i~t.lliti::': b,e,!""\\'c'f.:B 3x-;:·:.,:
\!' jl \~ .. ·•
JI i1~~1:::_~) . ,, ... ,,;,
.
!.i:.••I ~uElt ~lot 14
(''dri,;·-er to0l")
Figure 3 of Gjerde, as cited by the Examiner, shows the first axis
( dotted line) along the guide slot 24 which serves as the claimed "driver
tool" and the second axis (longitudinal colored bar) of the reamer 31 which
serves as the claimed "alignment member." The Examiner found that the
osteotomy plate 28 is the claimed "connector." The reamer 31 is inserted
through the hole 26' of the template 28. The distance between the first and
second axes as labeled by annotation in Figure 3 shows that, as the template
28 is adjusted, the distance between the axes would change.
Thus, the Examiner's determination that the "connector is sized for
determining a patient-specific distance between the reference axis and a
longitudinal axis of the driver tool for guiding the cutting tool into a patient-
specific position through femoral bone (as seen in Figure 3)" is supported by
a preponderance of the evidence. Final Act. 3.
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Appeal2017-007969
Application 13/041,883
Paragraphs 13 and 14, reproduced above, teach that the template is
adapted in size and shape to the patient and thus would be connected to the
alignment member in such a way that distance between the first and second
axes is patient-specific as required by claim 13.
Appellants state that the Gjerde's reamer 31 -the element the
Examiner found that corresponds to the claimed alignment member - "does
not disclose 'defining a reference axis for guiding a cutting tool into the
proximal femoral bone through a resected surface of the femoral neck."
Appeal Br. 16. However, claim 13 does not recite such language and thus
the argument is unavailing. Claim 13 recites "an elongated alignment
member attachable to the femoral guide and extending along a second axis."
As shown in Fig. 3 reproduced above, the alignment member or reamer 31 is
attachable to the device and defines a different second axis, meeting the
requirements of the claim.
Claim 13 further requires "a connector slidably couplable to the
alignment member and to the driver tool." As shown in Figure 3 of Gjerde
reproduced above, the alignment member ("reamer 31 )" is inserted through a
hole 26' of the connector/template 28 which is slidably connected to the
driver tool ("guide slot 24") meeting the corresponding limitation of the
claims. Appellants do not identify a defect in the Examiner's findings with
respect to these limitations (Final Act. 3) and we find none.
For the reasons given by the Examiner and the reasons discussed
above, we conclude that Gjerde describes a medical device that meets all the
limitations of claim 13. A claim is anticipated under 35 U.S.C. § 102 when
publication "disclose[ s] all elements of the claim within the four comers of
the document" and "arranged as in the claim." Net Money!N, Inc. v.
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Appeal2017-007969
Application 13/041,883
VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). Consequently, we
affirm the Examiner's determination that claim 13 is anticipated by Gjerde.
Claims 14, 16, and 17 were not argued separately in either the
anticipation rejection or the obviousness rejection and thus these claims fall
with claim 13. See 37 C.F.R. § 4I.37(c)(l)(iv).
Claim 28
Independent claim 28 is drawn to "medical device for preparing a
proximal femur for receiving an implant". The device comprises a femoral
guide and has the following structural limitations:
"at least partially defines a first opening with a closed periphery
for the femoral neck, a second opening with a closed periphery
for the greater trochanter, and a third opening with a closed
periphery for the femoral shaft"
The Examiner found these features met by Gjerde's device. The
Examiner identified elements 21, 20, and 22 of Figure 2b as meeting the
corresponding closed peripheries of the medical device. Final Act. 4.
We agree with Appellants that the Examiner has not established that
Gjerde describes a device with these features. As indicated by Appellants,
portions 22 and 24 appear to extend along one side of the proximal femur
rather than having a closed periphery as recited in claim 28. See Gjerde,
Figs. 2a, 2b, and 4d. The Examiner did not provide adequate evidence or
explanation how these apparently one-sided structures provided a closed
periphery for the femoral neck, greater trochanter, and femoral shaft as
required by claim 28. Consequently, because not all the limitations of claim
28 are described in Gjerde, we are compelled to reverse the anticipation
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Appeal2017-007969
Application 13/041,883
rejection of claim 28, and the rejections of dependent claims 29-38. Sanders
and White were additionally cited in the obviousness rejections, but not as
teaching the features found to be deficient in Gjerde.
DECISION
The anticipation and obviousness rejections of claims 1-7, 9-11, and
28-38 are reversed.
The anticipation and obviousness rejections of claims 13, 14, 16, and
1 7 are affirmed.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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