Ex Parte Snider et al

Patent Trial and Appeal Board

May 31, 2016

12775901 (P.T.A.B. May. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121775,901 05/07/2010
13387 7590 06/02/2016
SMITH & NEPHEW, INC.
ATTN: Chief Patent Counsel
7135 Goodlett Farms Parkway
Cordova, TN 38016
FIRST NAMED INVENTOR
Ashley M. Snider
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.
105826-0213-101 1094
EXAMINER
SEVILLA, CHRISTIAN ANTHONY
ART UNIT PAPER NUMBER
3775
NOTIFICATION DATE DELIVERY MODE
06/02/2016 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):
USPatentMail@ropesgray.com
USPatentMail2@ropesgray.com
Sabrina.Chambers@smith-nephew.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ASHLEY M. SNIDER, BRYAN I. NISHIMOTO,
MATTHEW J. DEMMER, DAVID MEHL,
TIMOTHY J. BOURNE, JAMES GATEWOOD,
PHILLIP FREDERICK, and ABRAHAM B. SALEHI
Appeal2014-002366
Application 12/775,901
Technology Center 3700
Before MICHELLE R. OSINSKI, JILL D. HILL, and ERIC C. JESCHKE,
Administrative Patent Judges.
HILL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Ashley M. Snider et al. (Appellants) appeal under 35 U.S.C. § 134
from the Examiner's final decision rejecting claims 1-13, 17-25, and 54. 1
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Claims 29-53 were withdrawn from consideration. Br. 19-25, Claims
App.
Appeal2014-002366
Application 12/775,901
CLAIMED SUBJECT MATTER
Independent claims 1, 1 7, and 54 are pending. Independent claim 1,
reproduced below, illustrates the claimed subject matter with key limitations
italicized.
1. An alignment guide configured to conform to
portions of a femoral neck and a femoral head of a femur of a
specific patient, the guide comprising:
a central member that includes a bore guide, the bore
guide configured to guide formation of a bore along a target
axis in the femoral head of the specific patient;
a plurality of arms extending from the central member,
each arm having an inner surface, a portion of the inner surface
of each arm configured to contact a portion of the femoral head
of the specific patient;
a head underside member connected to at least one of the
arms, the head underside member including an inner surface;
and
a neck member connected to the head underside member,
the neck member including an inner surface, wherein:
a conforming portion of at least one of the head
underside member inner surface and the neck member
inner surface is configured to contact a corresponding
portion of the femur of the specific patient; and
the plurality of arms, the head underside member
and the neck member are configured to cause the
alignment guide to grip the specific patient's femoral
head during formation of the bore in the specific patient's
femoral head, and to be removably retained in place on
the specific patient's femoral head in order to orient the
bore guide to guide formation of the bore along the target
axis in the specific patient's femoral head when the
conforming portion of the head underside member inner
surface or the neck member inner surface contacts the
corresponding portion of the femur of the specific
patient.
Br. 15, Claims App.
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Application 12/775,901
REJECTION
Claims 1-13, 17-25, and 54 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Kreuzer (US 2009/0118736 Al, pub. May 7, 2009) and
Aram (US 2009/0088760 Al, pub. Apr. 2, 2009). Ans. 2.
OPINION
Appellants argue claims 1, 3, 4, 6-13, 17, 19-25, and 54 as a group.
Br. 6. We select independent claim 1 as representative. See 37 C.F.R.
§ 41.37(c)(l)(iv)(2015). Claims 3, 4, 6-13, 17, 19-25, and 54 stand or fall
with claim 1.
Regarding claim 1, the Examiner finds that Kreuzer discloses the
claimed alignment guide, except for the surfaces of the arms, head underside
member, neck member, and finger being configured to engage or contact
portions of the femoral head and femoral neck of a specific patient. Final
Act. 3-5. The Examiner finds, however, that Aram discloses "a surgical tool
including a bone-contacting surface that matches or substantially matches a
bone of a particular patient," and concludes that it would have been obvious
to one having ordinary skill in the art to apply Aram's patient specific
surgical tool approach to Kreuzer' s alignment guide, "to reduce an
orthopaedic surgeon's guesswork and/or intra-operative decision-making
with respect to the placement of the tool." Final Act. 5---6 (citing Aram
ii 249, 11. 1-18).
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Appeal2014-002366
Application 12/775,901
Principle of Operation
Appellants first argue that the proposed combination of Kreuzer and
Aram would improperly change the principle of operation of Kreuzer. Br. 8.
Appellants appear to define the principle of operation of Kreuzer as a simple
and cost effective design, and more specifically as providing (1) "intra-
operative flexibility to allow a surgeon to select from different options when
drilling a bore in a femoral head," (2) "a cost effective approach because a
single guide design can be used on a variety of patient femurs," and (3) a
single guide design allowing a surgeon to "choose from the multiple bores
intraoperatively based on a patient's anatomy." Id. at 8-9. Appellants
contend that the Examiner's stated rationale for combining Kreuzer and
Aram highlights the change in principle of operation, because modifying
Kreuzer's drill guide to be patient-specific would increase the complexity of
its design and decrease cost effectiveness because a patient-specific guide
can only be used effectively for the patient for whom it is designed. Id. at 9.
The Examiner responds that "[ s ]implicity and cost effectiveness are
design goals that can be adhered to in the Kreuzer and Aram combination."
Ans. 12. According to the Examiner, Kreuzer does not specifically require
that its guide fit more than one patient. Id. Indeed, Kreuzer envisions that
various sizes of its guide can "accommodate different sized joints. For
example, women and children may have different joint sizes than an adult
male joint." Kreuzer ,-r 51. Thus, Kreuzer envisions some degree of
personalization (e.g., man, woman, child) in its guides. The principle of
operation proffered by Appellants is therefore too narrow, as this term
actually relates to the "basic principles" under which the prior art device was
designed to operate. See In re Ratti, 270 F.2d 810, 813 (CCPA 1959) ("This
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Appeal2014-002366
Application 12/775,901
suggested combination of references would require a substantial
reconstruction and redesign of the elements shown in [the primary reference]
as well as a change in the basic principles under which the [primary
reference] construction was designed to operate.") We therefore are not
persuaded by this argument.
Customization
Appellants next argue that: ( 1) the proposed combination of Kreuzer
and Aram fails to teach "an alignment guide having a bore guide that is
oriented along a target axis in the femoral head of a specific patient when
conforming portions of an inner surface of the guide contact corresponding
portions of the femur of the specific patient"; (2) neither reference teaches
"preoperatively designing a guide to align a bore with a target axis of a
specific patient's femur"; (3) Aram is "specific to knee joint cutting blocks"
and "does not provide a way to design a patient specific device for aligning a
drill guide for the hip joint at a patient's proximal femur"; and therefore (4)
the teachings of Aram fail to provide a rational underpinning for the
Examiner's proposed combination. Br. 10-11 (emphases removed).
According to Appellants, designing a knee-cutting block requires
accommodating a different anatomy (via different anatomical modeling)
than designing a guide for a femoral head. Id.
The Examiner does not rely on Aram for disclosing femoral head
modeling, but rather for customizing a guide. Ans. 12. It is Kreuzer that the
Examiner relies on for disclosing femoral head guide design. Final Act. 3.
Appellants thus are disagreeing with the Examiner's contention that one
skilled in the art could apply Aram's customization teachings to Kreuzer's
femoral head modeling to customize a femoral head for a specific patient.
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Application 12/775,901
Lacking an explanation of why this is so, we are not persuaded by this
argument, because "[a] person of ordinary skill in the art is also a person of
ordinary creativity, not an automaton." KSR Int'! Co. v. Teleflex Inc., 550
U.S. 398, 421 (2007). We discern no reason why one skilled in the art could
not apply Aram's customization teachings to Kreuzer's femoral head
modeling to customize a femoral head for a specific patient.
Slit Configured to Permit Withdrawal
Independent claim 17 and dependent claim 5 recite "a slit formed in
the central member and the bore guide, the slit configured to permit the
guide to be withdrawn from a structure extending from the femoral head of
the specific patient." Br. 16, 18, Claims App.
The Examiner finds that Kreuzer' s guide includes a slit (e.g., slots
152) formed in the central member and the bore guide, the slit being
configured to permit the guide to be withdrawn from a structure extending
from the femoral head of the patient. Final Act. 4.
Appellants argue that the combination of Kreuzer and Aram fails to
teach a slit as claimed. Br. 12. According to Appellants, the claimed
invention's slit permits withdrawal by allowing guide flexure, and Kreuzer's
inspection slot is not a slit, but rather is "a continuous and elongated circular
hole" that is "thus unable to allow for the guide of Kreuzer to flex." Id. at
12-13.
The Examiner responds that "[ s ]lot 152 can be considered a slit that
provides at least minimal levels of flexibility, e.g. when compared to
something that has no slot or slit." Ans. 13. Appellants do not refute this
response. We further note that guide flexure is not recited in claims 5 and
1 7. We therefore are not persuaded by this argument.
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Sleeve Cutter Guide
Dependent claims 2 and 18 recite "a curved sleeve cutter guide
connected to at least one of the arms, the sleeve cutter guide configured to
indicate a potential location of a surface formed by a sleeve cutter" or
substantially similar language. Br. 15, 18, Claims App.
The Examiner finds that Kreuzer teaches a sleeve cutter guide (e.g.,
locking holes 124) as claimed. Final Act. 6.
Appellants contend that, as discussed in their Specification, a sleeve
cutter guide references a cylindrical surface profile that a sleeve cutter will
form on a femoral head for a given location and orientation of a bore guide.
Br. 13 (citing Spec. i-f 62). Appellants argue that, in contrast, Kreuzer's
locking holes merely provide a means to restrict movement and rotation of
the guide, and therefore cannot be a sleeve cutter guide, or indicate a
potential location of a surface formed by a sleeve cutter. Id.
The Examiner responds that the claimed sleeve cutter guide "does not
structurally distinguish from Kreuzer['s] locking hole 124." Ans. 13 (citing
Kreuzer i-f 29, Fig. 2). We disagree.
We are persuaded by Appellants' argument. One skilled in the art of
hip joint bone modification would know what a sleeve cutter is, and what its
guide would comprise, and would not consider Kreuzer's locking holes 124
to be a sleeve cutter guide. We therefore do not sustain the rejection of
dependent claims 2 and 18.
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Application 12/775,901
DECISION
We AFFIRM the rejection of claims 1, 3-13, 17, 19-25, and 54 as
unpatentable over Kreuzer and Aram.
We REVERSE the rejection of claims 2 and 18 as unpatentable over
Kreuzer and Aram.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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