Ex Parte Komistek

Patent Trial and Appeal Board

Nov 28, 2018

13466944 (P.T.A.B. Nov. 28, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/466,944 05/08/2012 Richard D. Komistek
23643 7590 11/30/2018
Barnes & Thornburg LLP (IN)
11 S. Meridian Street
Indianapolis, IN 46204
UNITED ST A TES OF AMERICA
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.
265280-224334 7212
EXAMINER
WILLSE, DAVID H
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
11/30/2018 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):
INDocket@btlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD D. KOMISTEK 1
Appeal2017-011572
Application 13/466,944
Technology Center 3700
Before JAMES A. WORTH, TA WEN CHANG, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
prosthetic femoral component, which have been rejected as anticipated and
obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE and enter a new ground of rejection under 37 C.F.R.
§ 41.50(b).
STATEMENT OF THE CASE
The human hip is often described as a "ball and socket" joint. (Spec.
,r 2.) In hip replacement procedures (i.e., total hip arthroplasty ("THA")),
1 Appellant identifies the Real Party in Interest as DePuy (Ireland). (Appeal
Br. 2.)
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Application 13/466,944
the head (ball) and the neck of the femur is removed and the femur is reamed
and broached so that part of the interior of the proximal femur is hollowed
out. ( Greenlee2 1 :41--45.) Similarly, the socket of the hip is machined out
to a hemispherical shape and a titanium alloy part is secured in the socket
with a plastic liner fitted into the part. (Id. at 1:48-53.) Finally, a prosthetic
component having a ball and stem is implanted such that the stem is inserted
into the hollowed-out part of the femur and the ball is inserted into the
plastic socket prepared in the hip bone. (Id. at 1 :45--48, 53-55.)
According to the Specification, femoral head dislocation and
separation are major concerns with current THA implants even though they
are rare in anatomical hips. (Spec. ,r 4.) The Specification states that the
present invention relates to "components that may be implanted as part of a
prosthetic joint, such as a hip joint," that
allows for the bearing surface force of the hip joint, along
the mechanical axis of the leg, to pass through the
implanted femoral component, which may lead to one or
more of the following: (1) an increased bearing surface
contact area; (2) a significant reduction in bearing surface
contact stress; (3) a significant reduction in femoral head
separation; and, ( 4) a reduction of the out-of-plane forces
and bending moments applied to the trunnion. At the same
time, the implanted femoral component may attempt to
maintain the concentricity of the anatomical hip joint.
(Id. ,I,I 86, 87.)
Claims 1, 8, 9, 91, 100, and 122-124 are on appeal. Claim 1 is
illustrative and reproduced below:
1. A prosthetic femoral component comprising:
a femoral shaft including an elongated body that extends
from a proximal end to a distal tip and defines a femoral shaft
2 Greenlee, U.S. 7,179,298 B2, issued Feb. 20, 2007.
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Appeal2017-011572
Application 13/466,944
axis extending longitudinally through the proximal end and the
distal tip, the elongated body being configured to be inserted
into an intercondylar channel of a patient's femur;
a femoral neck operatively coupled to the femoral shaft at
the proximal end of the elongated body, the femoral neck
including a trunnion adapted to receive a femoral ball, the
femoral neck having a longitudinal axis extending from the
proximal end of the femoral shaft to a distal end of the trunnion,
the trunnion having a longitudinal axis extending from the
distal end of the trunnion to a proximal end of the trunnion;
and,
the femoral ball non-movably secured to the trunnion of
the femoral neck;
wherein when the prosthetic femoral component is
viewed in a coronal plane, (i) an angle greater than zero degree
is defined between the longitudinal axis of the femoral neck and
the longitudinal axis of the trunnion, and (ii) the distal end of
the trunnion is offset from the femoral shaft axis between 5 and
160 millimeters.
(Appeal Br. 18 (Claims App.).
The Examiner rejects claims 1, 91, 100, and 122-124 under pre-AIA
35 U.S.C. § 102(b) as being anticipated by Greenlee. (Ans. 2.)
The Examiner rejects claims 8 and 9 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Greenlee and Tager. 3 (Ans. 4.)
I.
Issue
The Examiner has rejected claims 1, 91, 100, and 122-124 as
anticipated by Greenlee. The Examiner has rejected claims 8 and 9 as
obvious over Greenlee and Tager. The same issues are dispositive for these
rejections; we therefore discuss them together.
3 Tager, DE 3916231 Al, published Nov. 22, 1990.
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Application 13/466,944
The Examiner finds that Greenlee discloses all of the limitations of
claims 1, 91, 100, and 122-124 and cites Tager only for the disclosure of the
retention bracket recited in claims 8 and 9. (Ans. 2-5.) Appellant contends
that Greenlee does not disclose a prosthetic femoral component comprising a
femoral neck including a trunnion and having "a longitudinal axis extending
from the proximal end of the femoral shaft to a distal end of the trunnion,"
as required by all of the claims. (Appeal Br. 5, 14--16.) Appellant further
argues that Greenlee does not disclose a femoral ball "non-movably secured
to the trunnion" of the femoral neck, as required by claims 1 and 100 and
their dependent claims, or a distal end of the trunnion that is "offset from the
femoral shaft axis between 5 and 160 millimeters," as required by claim 1
and its dependent claims. (Appeal Br. 5, 15-16.)
The issue with respect to these rejections is whether a preponderance
of the evidence of record supports the Examiner's finding that Greenlee
teaches each limitation of independent claims 1, 91, and 100 arranged in the
same way as recited in the claims.
Analysis
We find that the Examiner has not established a prima facie case that
Greenlee anticipates independent claims 1, 91, and 100.
Claim 1 recites a prosthetic femoral component comprising, among
other things, "[a] femoral neck including a trunnion adapted to receive a
femoral ball," where "the femoral neck [has] a longitudinal axis extending
from the proximal end of the femoral shaft to a distal end of the trunnion"
and "the trunnion [has] a longitudinal axis extending from the distal end of
the trunnion to a proximal end of the trunnion." ( Appeal Br. 18 ( Claims
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Application 13/466,944
App.).) The other independent claims on appeal, claims 91 and 100, also
recite similar language. (Id. at 19-20 (Claims App.).)
The Examiner identifies one of the needle bearing assemblies in
Greenlee's hip prosthesis as the trunnion required by the claims. (Ans. 2-3,
5.) To facilitate our analysis, we reproduce an annotated version of
Greenlee's Figure 4 below:
prox:iri'ia! end of
triunnion
I trunnion I
ba!I diameter is
4 1.625 inches
{col. 4, !L 21-23}
or4.13 cm
.5 •••.•.. -"'-~"_,..__~/-----
. / proximal end of
/ te?Qoral shaft
elongated bod>'
\ \:
~
: '1 . E
:i /
/'
' !
Greenlee' s Figure 4 is a partially cross-sectional depiction of an embodiment
of Greenlee' s invention, showing an anterior view of the left hip with the
pelvis, the primary bearing system and the secondary bearing system in
cross section. ( Greenlee 3: 1-7.) The annotated Greenlee Figure 4
reproduced above is adapted from the annotated version of the same figure
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Appeal2017-011572
Application 13/466,944
included in the Examiner's Answer, modified to increase the clarity of the
Examiner's annotations. (Ans. 3.)
As discussed above, the Examiner points to one of the needle bearing
assemblies-labeled Jin Greenlee's Figure 4---as the trunnion. (Ans. 2-3,
5.) As shown in the annotated Figure 4 above, the Examiner also appears to
identify the end face of the assembly, labeled K in Figure 4, as the proximal
end of the trunnion, and the opposing face of the needle bearing assembly
(i.e., the side of the needle assembly facing the femoral neck) as the distal
end of the trunnion, such that the "longitudinal axis" of the trunnion is
perpendicular to the femoral shaft axis. (Id. at 3.)
We are not persuaded, based on the features of Greenlee' s prosthesis
relied upon by the Examiner, that the Examiner has shown that Greenlee
teaches a femoral neck having a longitudinal axis extending from the
proximal end of the femoral shaft to a distal end of the trunnion, or properly
identified a longitudinal axis of the trunnion extending from the distal end of
the trunnion to the proximal end of the trunnion.
The common and ordinary meaning of "distal" in anatomy refers to
the portion of, e.g., a limb that is situated further away from the point of
attachment to, or the central mass of, the body, while "proximal" generally
refers to a portion situated nearer to the point of attachment to, or the central
mass of, the body. 4 The "proximal" and "distal" ends of the trunnion
identified by the Examiner, however, are not "nearer" or "further away"
from the central mass of the body in this anatomical sense. In other words,
4 See, e.g., "distal." MERRIAM-WEBSTER, https://www.merriam-
webster.com/dictionary/distal (last visited Nov. 19, 2018) (defining "distal"
as "situated away from the point of attachment or origin or a central point
especially of the body").
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Appeal2017-011572
Application 13/466,944
they are not proximal/ distal to each other but are rather medial/lateral to
each other. 5 Because the Examiner has not properly identified a "distal end"
of the structure in Greenlee he cites to meet the "trunnion" limitation of the
claims, the Examiner has not established a prima facie case that Greenlee
teaches a prosthetic femoral component comprising a femoral neck including
a trunnion and having a longitudinal axis extending from the proximal end
of the femoral shaft to a distal end of the trunnion, as required by each of the
independent claims.
Accordingly, we reverse the Examiner's rejection of independent
claims 1, 91, and 100 as anticipated by Greenlee. We also reverse the
Examiner's rejections of claims 8, 9, and 122-124, which depend directly or
indirectly from claims 1, 91, or 100, for the same reasons. 6 Cf In re Fine,
837 F.2d 1071 (Fed. Cir. 1988) ("Dependent claims are nonobvious
under section 103 if the independent claims from which they depend are
nonobvious.").
II.
Under the provisions of 37 C.F.R. § 41.50(b ), we enter the following
new ground of rejection: Claim 91 is rejected as anticipated over Greenlee.
Claim 91 is reproduced below:
5 Medial refers to extending toward the median axis of the body while lateral
refers to extending toward the sides of the body. See, e.g., "medial."
MERRIAM-WEBSTER, https://www.merriam-webster.com/ dictionary/medial
(last visited Nov. 19, 2018.)
6 As discussed above, the Examiner also cites Tager in the obvious rejection
of claims 8 and 9. However, the Examiner cites Tager only for its disclosure
of the dependent claim limitations relating to a retention bracket. (Ans. 4--
5.) Thus, Tager does not cure the deficiency in the Examiner's prima facie
case with respect to Greenlee.
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Appeal2017-011572
Application 13/466,944
91. A prosthetic femoral component comprising:
a femoral shaft including an elongated body that extends
from a proximal end to a distal tip and defines a femoral shaft
axis extending longitudinally through the proximal end and the
distal tip of the femoral shaft, the elongated body being
configured to be inserted into an intercondylar channel of a
patient's femur; and
a femoral neck adapted to be coupled to the proximal end
of the femoral shaft, the femoral neck including a trunnion such
that (i) a longitudinal axis of the femoral neck extends from the
proximal end of the femoral end of the femoral shaft to a distal
end of the trunnion, and (ii) a longitudinal axis of the trunnion
extends from the distal end of the trunnion to a proximal end of
the trunnion;
wherein when the femoral neck is non-movably secured
to the proximal end of the femoral shaft and the prosthetic
femoral component is viewed in a coronal plane, an angle
greater than zero degree is defined between the longitudinal
axis of the femoral neck and the longitudinal axis of the
trunnion.
(Appeal Br. 19 (Claims App.).)
Greenlee teaches a femur side hip prosthesis (i.e., "a prosthetic
femoral component") including "both a ball and socket bearing and another
(secondary) bearing system which facilitates motion of the type which is
primarily in the forward and backward swinging of the leg." ( Greenlee
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Appeal2017-011572
Application 13/466,944
Abstract.) To facilitate our analysis, an annotated version of Greenlee's
Figure 1 is reproduced below:
f,ifrn¢i·a; shaft
,:' ' '
inctl~ding ~n
$~~~,g~t~d 00::Jy
F,::,_
::
L., ... " ......... .
Figure 1 of Greenlee is "a partially cross-sectional depiction of [ an
embodiment] of the invention disclosed [in Greenlee]," wherein "[t]he view
is an anterior view of the left hip" and "the pelvis, the primary bearing
system and the secondary bearing system are shown in cross-section." (Id.
at 3:29--33.) As discussed in Greenlee, Figure 1 shows "[a] ball 1
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Appeal2017-011572
Application 13/466,944
interfac[ing] with a socket liner 5 within an acetabulmn shell prosthetic
implant 6 which is secured within the pelvis 4." (Id. at 3:35-37.)
As shown in the annotated version of Greenlee' s Figure 1 above, the
prosthetic femoral component taught by Greenlee comprises a femoral shaft
having an elongated body extending from a proximal end to a distal tip,
defining a femoral shaft axis extending longitudinally, and configured to be
inserted into an intercondylar channel of the femur. Greenlee' s component
also includes a femoral neck (i.e., the portion of Figure 1 labeled 3) adapted
to be coupled to the femoral shaft at the proximal end of the shaft, wherein
the femoral neck includes a trunnion (i.e., the portion of the prosthesis
indicated by a border of dashed lines in Figure 1 above). 7
As further shown above in the annotated figure, the longitudinal axis
of the femoral neck extends from the proximal end of the femoral shaft to a
distal end of the trunnion, the longitudinal axis of the trunnion extends from
its distal to its proximal end, and these two axes define an angle, 8, greater
than zero degrees when the component is viewed in a coronal plane and the
femoral neck is non-movably secured to the proximal end of the femoral
shaft. 8 In short, Greenlee teaches a prosthetic femoral component that meets
each limitation of claim 91.
7 We construe trunnion to mean "a pin or pivot on which something can be
rotated or tilted." See, e.g., "trunnion." MERRIAM-WEBSTER,
https://www.merriam-webster.com/dictionary/trunnion (last visited Nov. 21,
2018); see also Spec. ,r 9 ( describing "a femoral head that is removable from
an end (i.e., trunnion) of the femoral neck").
8 Greenlee teaches embodiments where the femoral neck is non-movably
secured to the proximal end of the femoral shaft. In particular, Greenlee
teaches an embodiment having "a modular connection between the stem for
placement within the femur and the assembly that includes the secondary
bearing," wherein the modular neck component has a "self-locking" taper
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Appeal2017-011572
Application 13/466,944
SUMMARY
For the reasons above, we reverse the Examiner's decision rejecting
claims 1, 8, 9, 91, 100, and 122-124.
We enter a new ground of rejection of claim 91 as anticipated by
Greenlee. We have not entered new rejections of claims 1 and 100, or their
dependent claims; we express no opinion as to whether new grounds of
rejections are appropriate with respect to those claims.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review." Section 4I.50(b) also provides:
When the Board enters such a non-final decision, the
appellant, within two months from the date of the decision,
must exercise one of the following two options with
respect to the new ground of rejection to avoid termination
of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence
relating to the claims so rejected, or both, and have the
matter reconsidered by the examiner, in which event the
prosecution will be remanded to the examiner. The new
ground of rejection is binding upon the examiner unless an
configured to engage the stem. (Greenlee 3:25-28, 3:49---63.) Greenlee also
teaches an embodiment without such a modular connection between the
femoral neck and femoral shaft, which would also mean that the femoral
neck is non-movably secured to the proximal end of the femoral shaft. (Id.
at 3 :23-28 (principal difference between two disclosed embodiments is with
respect to whether there is a modular connection between stem for
placement within femur and assembly including the secondary bearing).)
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Application 13/466,944
amendment or new Evidence not previously of Record is
made which, in the opinion of the examiner, overcomes
the new ground of rejection designated in the decision.
Should the examiner reject the claims, appellant may again
appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding
be reheard under § 41.52 by the Board upon the same
Record. The request for rehearing must address any new
ground of rejection and state with particularity the points
believed to have been misapprehended or overlooked in
entering the new ground of rejection and also state all
other grounds upon which rehearing is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
REVERSED; 37 C.F.R. § 4I.50(b)
12