Ex Parte Iannotti et al

Patent Trial and Appeal Board

Aug 8, 2016

12343272 (P.T.A.B. Aug. 8, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/343,272 12/23/2008
28078 7590 08/09/2016
MAGINOT, MOORE & BECK, LLP
One Indiana Square, Suite 2200
INDIANAPOLIS, IN 46204
FIRST NAMED INVENTOR
Joseph P. Iannotti
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.
1671-0454 4158
EXAMINER
DUKERT, BRIAN AINSLEY
ART UNIT PAPER NUMBER
3738
MAILDATE DELIVERY MODE
08/09/2016 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 PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH P. IANNOTTI,
KYLEE. LAPPIN, SARAH M. ANTHONY,
and GERALD R. WILLIAMS, JR.
Appeal2014-008546
Application 12/343,272
Technology Center 3700
Before JAMES P. CALVE, AMANDA F. WIEKER,
and FREDERICK C. LANEY, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the non-final rejection
of claims 1-5, 7, 9-13, 16, and 28-30. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
Appeal2014-008546
Application 12/343,272
CLAIMED SUBJECT MATTER
Claim 1, the sole independent claim on appeal, is reproduced below.
1. A shoulder prosthesis, comprising:
a metaglene component including (i) a base having a
bearing-facing side, a scapula-facing side, and an external
coupling surface interposed therebetween, (ii) an augment
attached to and in direct contact with the base on the scapula-
facing side of the base, and (iii) a post attached to the base, the
metaglene component having defined therein a passage
extending through at least both the base and the post, and the
metaglene component further having a plurality of fastener
holes defined in the base, at least one of the fastener holes
extending through the augment;
a bearing component defining a cavity and including a
bearing surface, the cavity defining an internal coupling
surface, and the bearing-facing side of the metaglene
component being located within the cavity so that the external
coupling surface of the base is positioned in contact with the
internal coupling surface of the bearing component to form a
friction fit connection between the bearing component and the
metaglene component; and
a plurality of fasteners configured to respectively extend
through the plurality of fastener holes defined in the base;
wherein the augment includes i) an external sidewall that
is aligned with the external coupling surface and extends
circumferentially around a portion of the base, ii) an inner edge
that extends across the scapula facing side of the base from one
end of the external sidewall to the other end of the external
sidewall, and iii) a first scapula facing surface that extends
between the external sidewall and the inner edge;
wherein the scapula-facing side of the base includes a
second scapula-facing surface that extends between a remaining
portion of the external coupling surface and the inner edge of
the augment; and
wherein the first scapula-facing surface is offset from the
second scapula-facing surface.
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Appeal2014-008546
Application 12/343,272
REJECTION
Claims 1-5, 7, 9-13, 16, and 28-30 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Bouttens (US 6,953,478 B2, iss. Oct. 11,
2005) and Kelman (US 5,531,793, iss. July 2, 1996).
ANALYSIS
Appellants argue claims 1-5, 7, 9-13, 16, and 28-30 as a group and
present separate arguments for claims 5 and 7. Appeal Br. 3-8. We select
claim 1 as representative. See 37 C.F.R. § 41.37(c)(l)(iv). We address
Appellants' arguments for claims 5 and 7, separately.
Claims 1--4, 9-13, 16, and 28-30
The Examiner found that Bouttens teaches a shoulder prosthesis with
metaglene component 7, bearing component 9, and a plurality of fasteners
25, 27, but does not teach an augment as claimed. Non-Final Act. 5-7. The
Examiner found that Kelman teaches implants with wedges or augments 20
that fill gaps between the implant and bone surface to compensate for bone
loss. Id. at 7-8. The Examiner determined that it would have been obvious
to integrate Kelman's augments/wedges with the device of Bouttens to make
a shoulder prosthesis that is capable of compensating for bone loss or wear
of the glenoid. As modified, the shoulder prosthesis of Bouttens would have
an augment 20 attached to the scapular side of the base with an external side
wall that is aligned with the external coupling surface, as shown in Figure 1
of Kelman, and an inner edge, as claimed. Id. at 8. The Examiner reasoned
that it would have been obvious to extend the augment circumferentially at
the base of Bouttens to provide a well-contoured implant without any ledges
or protrusions that could affect implant performance. Id. at 8-9.
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Appeal2014-008546
Application 12/343,272
Appellants argue that Kelman teaches wedge shaped augments on
tibial tray implants that are secured with bone cement rather than fasteners,
so there is no teaching or suggestion in Kelman of providing augments on
implants at positions where fasteners are routed or received. Appeal Br. 4--
5; Reply Br. 3. Appellants also argue that the Examiner has not provided a
reason to modify Bouttens to include an augment on an implant secured to
bone with bone screws or fasteners or to include an augment at a location
where a fastener is located. Appeal Br. 5. Appellants further argue that just
because a metaglene component of Bouttens could be modified to include an
augment of Kelman does not mean that a skilled artisan would have found it
obvious to do so, and the Examiner failed to provide a single example of a
use of an augment on a metaglene component of a shoulder prosthesis in the
prior art. Reply Br. 2.
The Examiner's reason for combining Kelman's augments with the
shoulder prosthesis of Bouttens is supported by rational underpinning. The
Examiner determined that it would have been obvious to integrate Kelman's
augments into an implant of Bouttens to construct a shoulder prosthesis that
is capable of compensating for the bone loss and wear of the glenoid. Non-
Final Act. 8. The Examiner relied on Kelman's teaching to use augments to
compensate for bone loss due to wear and disease and prevent gaps between
a bone and any type of implant. Id. at 7 (citing Kelman, Abstract, 4: 13-17);
Ans. 2-3 (citing Kelman, 3 :34--36); Kelman, 1: 10-25. The Examiner found
that such augments provide stable anchor points that prevent migration and
promote proper joint operation so that a skilled artisan would have wanted to
provide these benefits on Bouttens' device, which also is applied to a joint.
Ans. 2-3. Appellants do not persuade us of error in that determination.
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Appeal2014-008546
Application 12/343,272
In this regard, Kelman teaches "an orthopedic implant augmentation
and stabilization device" that "facilitates coupling of an augment to a surface
of an orthopedic implant to compensate for bone loss while minimizing
surgical time and manufacturing costs." Kelman, 1: 10-15. While Kelman
illustrates the invention in a tibial implant, Kelman discloses and claims the
invention as applicable to implants generally such that "the present invention
can be used with tibial components, femoral components, or any other type
of implant which may require augments." Id. at 3:35-37, 4:11-16, 6:32-50
(claim 1 ). In light of these teachings, Appellants have not persuaded us of
error in the Examiner's reasoning that augments would have been useful in a
shoulder implant of Bouttens to compensate for bone loss and thus provide a
stable implant foundation, e.g., by filling in gaps as Kelman teaches.
Appellants argue that Kelman does not teach an augment attached to
and in direct contact with the base, as claimed, but instead uses acrylic pegs
24 and standoffs 3 8 to prevent direct contact between the augment and base
and places bone cement 32 in the space between the augment 20 and bottom
surface 18 of tray 14. Appeal Br. 5. As a result, Appellants argue that the
proposed combination does not arrive at an augment "attached to and in
direct contact with the base on the scapula-facing side of the base." Id.
Appellants' arguments are not persuasive of error in the Examiner's
determination that it would have been obvious combine Kelman's augment
with Bouttens' base as a unitary, monolithic structure that would prevent
undesirable metal-on-metal contact and articulation. Ans. 4. As modified,
Bouttens' prosthesis would not require any cement and would provide direct
contact between its base and the augment of Kelman.
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Appeal2014-008546
Application 12/343,272
The decision to make elements of a device integral or separable can be
a matter of obvious engineering choice, as the Examiner determined, absent
a disclosure that a particular feature is critical to an invention. See In re
Larson, 340 F.2d 965, 968 (CCPA 1965); In re Dulberg, 289 F.2d 522, 523
(CCP A 1961) (obvious to make a press-fit cap of the prior art removable if
there was any reason to access the end of the holder); In re Fridolph, 309
F.2d 509, 512-513 (CCPA 1962) (noting decisions that hold the integration
of separate elements to be obvious and holding that making prior art sleeves
integral with slidable disks was not patentable where integration involved
mere mechanical skill and only improved results). Appellants do not assert
any unexpected results or criticality to this arrangement. The Specification
discloses augment 40 as integrally formed with base 36, or as removably
attached to base 36 by a coupling mechanism (not shown). Spec. 8:12-15.
The Examiner reasoned that making the augment integral with a base would
prevent the metal-on-metal problems discussed in Kelman. Ans. 4; Kelman,
1:21-39. Appellants have not apprised us of error in that determination.
Appellants argue that because Kelman does not teach or suggest the
use of augments on implants that require fasteners or augments with fastener
holes for receiving fasteners that secure an implant to a bone, there is no
teaching or suggestion to provide an augment with a fastener hole that aligns
with a fastener hole in the base. Appeal Br. 6, 7; Reply Br. 3. Appellants
assert that Kelman's tibial tray is secured to bone using cement whereas a
metaglene component for the shoulder prosthesis in Bouttens requires plural
fasteners to secure it to the glenoid, and the Examiner has not provided any
evidence that a skilled artisan would have extended fastening holes through
the augment. Reply Br. 2-3.
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Appeal2014-008546
Application 12/343,272
Appellants' arguments are not persuasive of error in the Examiner's
determination that it would have been obvious to include Kelman's augment
integrally with the base of Bouttens' shoulder prosthesis where the fastener
holes in Bouttens' base would extend through the integral augment. In this
regard, Kelman illustrates augments 20 with apertures 21 extending entirely
through the augment, as illustrated in Figure 1, so that pegs 24 may extend
completely through augment 20 to provide a means to align implant 14 with
the bone. Kelman, 4:28-58. The Examiner reasonably determined that the
fastening holes in Bouttens' implant would extend through the augment to
ensure proper anchoring of the implant, as Bouttens teaches, without cement.
Thus, we sustain the rejection of claims 1--4, 9-13, 16, and 28-30.
Claims 5 and 7
Dependent claim 5 recites "the inner edge of the augment includes a
post attachment portion that is attached to the post and extends around a
portion of a circumference of the post." The Examiner found that the size
and placement of the augment would dictate how it attaches, surrounds, or
interacts with the base's post and would have been an obvious matter of
engineering choice within the level of ordinary skill. Non-Final Act. 10.
Appellants argue that Bouttens does not teach or suggest augments on
the base of a metaglene component and Kelman is directed to preventing any
contact of the metal augment and metal base and thus teaches away from any
augments that extend into contact with stem 12. Appeal Br. 7-8.
Appellants' arguments amount to individual attacks on the references
and thus are not persuasive. The Examiner reasonably determined that the
combined teachings of the references would result in an augment of varying
shapes and sizes that, in some cases, would encompass the post, as claimed.
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Appeal2014-008546
Application 12/343,272
Dependent claim 7 recites "at least one of the plurality of fastener
holes includes an end opening that is at least partially defined in the external
sidewall of the augment." The Examiner found that Bouttens teaches angled
fasteners and associated holes and reasoned that the addition of Kelman' s
augments formed integrally with Bouttens' base would have resulted in the
angled trajectory of the fastener holes in Bouttens' base passing through the
external sidewall of the augment. Non-Final Act. 10-11.
Appellants argue that the prior art does not teach or suggest fastener
holes extending through the sidewalls of augments. Appeal Br. 8. This
argument is not persuasive of error in the Examiner's determination as set
forth above. The Examiner reasonably concluded that any fastener holes
that angle outwardly from Bouttens' metagloid element 7 (see Fig. 2) also
would pass through any augment formed integrally therewith to include an
external sidewall of the augment that was within that trajectory.
Thus, we sustain the rejection of claims 5 and 7.
DECISION
We AFFIRM the rejection of claims 1-5, 7, 9-13, 16, and 28-30.
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
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