Ex Parte Aram et al

Patent Trial and Appeal Board

Sep 22, 2017

12241002 (P.T.A.B. Sep. 22, 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.
12/241,002 09/29/2008 Luke J. Aram 265280-207015 6362
23643 7590 09/26/2017
Barnes & Thornburg LLP (IN)
11 S. Meridian Street
Indianapolis, IN 46204
EXAMINER
SEVILLA, CHRISTIAN ANTHONY
ART UNIT PAPER NUMBER
3775
NOTIFICATION DATE DELIVERY MODE
09/26/2017 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):
INDocket@btlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LUKE J. ARAM, MARK B. LESTER, BRYAN ROSE,
JOSEPH G. WYSS, RICHARD BEECH, and LABAN COOK
Appeal 2016-000605
Application 12/241,002
Technology Center 3700
Before LINDA E. HORNER, LISA M. GUIJT, and PAUL J. KORNICZKY,
Administrative Patent Judges.
KORNICZKY, Administrative Patent Judge.
DECISION ON APPEAL
Appeal 2016-000605
Application 12/241,002
STATEMENT OF THE CASE
Appellants, Luke J. Aram et al.,1 appeal under 35 U.S.C. § 134(a)
from the Examiner’s decision, as set forth in the Final Office Action dated
September 12, 2014 (“Final Act.”), rejecting claims 1—6, 13—16, 19, and 20
under 35 U.S.C. § 103(a) as being unpatentable over Bertin (US 5,908,424,
issued June 1, 1999) and Burdulis (US 2005/0234461 Al, published October
20, 2005).2 We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
THE CLAIMED SUBJECT MATTER
The claims are directed to a customized patient-specific bone cutting
instrument. Claims 1 and 13 are the independent claims on appeal. Claim 1,
reproduced below with disputed limitations italicized for emphasis, is
illustrative of the claimed subject matter:
1. A customized patient-specific orthopaedic instrument
assembly, comprising:
a customized patient-specific cutting block comprising
(i) a bone-facing surface having a customized patient-specific
negative contour configured to receive a portion of an anterior
side of a bone of a knee of a patient that has a corresponding
contour, (ii) an outer surface opposite the bone-facing surface,
(iii) at least one guide pin hole, and (iv) a cutting guide,
an ankle brace configured to be secured externally to an
ankle of the patient, and
1 Appellants identify DePuy Synthes Products, Inc., a Johnson &
Johnson Company, as the real party in interest. Appeal Brief, dated
April 9, 2015 (“Appeal Br.”), at 2.
2 Claims 7—12, 17, and 18 are withdrawn from consideration. Final
Act. 1 (Office Action Summary).
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Application 12/241,002
an external alignment rod having a first end secured to the
customized patient-specific cutting block and a second end
secured to the ankle brace,
wherein the customized patient-specific negative contour
of the bone-facing surface includes a unique plurality of
depressions and ridges that match a corresponding plurality of
ridges and depressions of the portion of the anterior side of the
bone of the knee of the patient.
DISCUSSION
The Rejection of Claims 1—6, 13—16, 19, and 20
as Unpatentable Over Bertin and Burdulis
Claims 1—3, 5, 6, 13—16, and 20
Appellants argue claims 1—3, 5, 6, 13—16, and 20 as a group. Appeal
Br. 4; see also id. at 4—12. We select claim 1 as the representative claim, and
claims 2, 3, 5, 6, 13—16, and 20 stand or fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv). Claims 4 and 19 are addressed below.
The Examiner finds that Bertin discloses all of the limitations of claim
1 except that Bertin’s negative contour of the bone-facing surface does not
include a unique plurality of depressions and ridges that match a
corresponding plurality of ridges and depressions of the portion of the
anterior side of the bone of the knee of the patient. Final Act. 4. For this
missing limitation, the Examiner finds that Burdulis discloses a tool that is
customizable or highly selectable by patient to increase speed and accuracy
and Figure 6 discloses surface 613 with an irregular surfaces with valleys
and hills that conform to a surface of a bone. Id. at 4—5. The Examiner
determines that it would have been obvious “to have provided the irregular
surface with valleys and hills that conform to a surface of a bone of Burdulis
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Application 12/241,002
to the bone-facing surface of Bertin in order to increase speed and
accuracy.” Id. at 5.
Appellants argue that the Examiner’s rejection is erroneous for several
reasons. First, Appellants argue that Bertin does not disclose “a customized
patient-specific cutting block comprising (i) a bone-facing surface having a
customized patient-specific negative contour configured to receive a portion
of an anterior side of a bone of a knee of a patient that has a corresponding
contour,” as recited in claim 1. Appeal Br. 4; see id. at 4—8. Appellants
argue that “a ‘customized patient-specific negative contour configured to
receive a portion of an anterior side of a bone of a knee of a patient that has
a corresponding contour’ requires the contour to be shaped to match the
shape of a particular bone of a particular patient at a unique location on the
patient’s bone.” Id. at 6 (citing Spec. 248, 249).
According to Appellants, “Bertin discloses a standard, generic
surgical instrument that does not include a contour that is customized to a
specific patient” {id. at. 5), and a “bone-contacting surface of a standard,
generic surgical instrument does not include such a customized patient-
specific negative contour because it is structured for use with any patient and
not any specif c patient {id. at 7). See id. at 5—8.
However, Appellants are attacking the teachings of Bertin
individually. Nonobviousness cannot be established by attacking the
references individually when the rejection is predicated upon a combination
of prior art disclosures. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir.
1986). Here, the Examiner finds,3 in part, that Burdulis, not Bertin,
3 The Examiner also finds that Bertin discloses that “the contour is
‘slightly arcuate’ to ‘conform to the anterior contour of tibial head 3 ’ which
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Application 12/241,002
discloses surface 613 for conforming to a bone surface that corresponds to
“a customized patient-specific negative contour configured to receive a
portion of an anterior side of a bone of a knee of a patient that has a
corresponding contour,” as recited in claim 1. Final Act. 4—5; Ans. 3. This
argument of Appellants does not address the rejection as articulated by the
Examiner, and, thus, does not identify error by the Examiner.
Second, Appellants argue that “Bertin ‘teaches away’ from the
proposed modification.” Appeal Br. 8; see id. at 8—12. According to
Appellants, “Bertin’s disclosure would have led a person of ordinary skill
away from adding to Bertin’s device ‘a unique plurality of depressions and
ridges that match a corresponding plurality of ridges and depressions’ of a
particular portion of a patient’s bone.” Id. at 9. Appellants argue that
because “Bertin refers to [] adjustability as an advantage of its invention
“Bertin therefore teaches away from a device that would pre-position a
cutting block at a single location relative to the patient’s bone,” and “a
person of ordinary skill would have been led away from modifying the base
assembly 40 to include structure that would position the base assembly at a
single, unique location relative to the bone.” Id. at 11. Appellants also
argue that because Bertin “teaches that the milling base 40 must be first
properly positioned, which is accomplished by the surgeon adjusting the
position of the milling base relative to the bone to select the proper position
for the base during the surgery,” “Bertin therefore teaches away from a
device including a unique plurality of depressions and ridges that match a
corresponding plurality of ridges and depressions of a predetermined,
provides a strong indication that the contour, at least to an extent, conforms
to a particular patient.” Ans. 3 (citing Bertin 4:53—60).
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Application 12/241,002
particular portion of a patient’s bone such that the device is located at a
single, pre-determined location on the patient’s bone.” Id. at 12.
Appellants’ argument that Bertin “teaches away” from the proposed
modification is unpersuasive because it does not address the proposed
combination of Bertin and Burdulis to achieve “a bone-facing surface having
a customized patient-specific negative contour configured to receive a
portion of an anterior side of a bone of a knee of a patient that has a
corresponding contour,” as recited in claim 1. The Examiner finds that
Bertin discloses a negative contour configured to receive a portion of the
anterior side of a bone of a knee. Ans. 3. The Examiner, for example,
correctly finds that the face of Bertin’s base 60 is “slightly arcuate” to
“conform to the anterior contour of tibial head 3.” Ans. 3 (citing Bertin
4:53—60). Assuming arguendo that Bertin does not disclose the patient-
specific negative contour recited in claim 1, the Examiner determines that it
would have been obvious to modify Bertin’s contour to include Burdulis’
surfaces that more closely match the convex anterior contour of tibial head
3. Ans. 3. Because Bertin uses a negative contour that conforms to the
tibial head, it does not criticize, discredit, or discourage the use of a patient-
specific negatively-contoured surface that is configured to receive a
corresponding contour of a knee bone. DePuy Spine, Inc. v. Medtronic
Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (“A reference
does not teach away, however, if it merely expresses a general preference for
an alternative invention but does not ‘criticize, discredit, or otherwise
discourage’ investigation into the invention claimed.”) (quoting In re
Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)).
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Appellants’ argument also is unpersuasive because the claimed cutting
block must be adjustable so that it may be aligned adjacent to the knee.
Claim 1, for example, recites “an external alignment rod.” According to
Figure 100 and paragraphs 461 and 463 of the Specification, for example,
telescoping alignment rod 4304 is adjustable and permits vertical alignment
of cutting block 4302 relative to the knee bone.
Finally, Appellants argue, without explanation, that “absent the benefit
of hindsight afforded by Appellant’s specification, a person of ordinary skill
would not have modified Bertin in view of Burdulis.” Appeal Br. 13.
Appellants’ conclusory statement, however, does not identify any knowledge
relied upon by the Examiner that was gleaned only from Appellants’
disclosure and that was not otherwise within the level of ordinary skill at the
time of the invention, thereby obviating Appellants’ assertion of hindsight.
See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Here, the
disclosure of Bertin (see, e.g., Bertin 2:21—29, 4:53—60, Fig. 1,15; the
Examiner’s annotated Fig. 15) and Burdulis (see, e.g., Burdulis Abstract,
11 87—88, Figs. 6B-6D) supports the Examiner’s findings and reasoning.
Thus, Appellants do not apprise us of error.
For the reasons above, the rejection of claim 1 is sustained. Claims 2,
3, 5, 6, 13—16, and 20 fall with claim 1.
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Claims 4 and 19
Appellants argue claims 4 and 19 as a group. Appeal Br. 4; see also
id. at 13—14. We select claim 4 as the representative claim, and claim 19
stands or falls with claim 4. 37 C.F.R. § 41.37(c)(l)(iv).
Claim 4, which depends from claim 1, further requires the
“customized patient-specific cutting block” to comprise “a customized
patient-specific femoral cutting block.” Appeal Br. 15 (Claims App.).
The Examiner finds that Bertin’s “customized patient-specific cutting
block comprises a customized patient-specific femoral cutting block
(element 60 can be used to cut a femur).” Final Act. 5.
Appellants argue that the Examiner’s finding is erroneous because
Bertin discloses a ‘“Tibia! milling guide system’ and does not teach or
suggest that such a tibial milling guide system may be used with a femur.”
Appeal Br. 13. Appellants also argue that “the rejection has failed to
properly interpret the phrase ‘customized patient-specific femoral cutting
block,’ which a person of ordinary skill would understand is a cutting block
that includes structure configured to position the cutting block in a sinsle,
unique, pre-determined location on one femur of aparticular patient.” Id. at
13—14. Contrary to Appellants’ arguments, Bertin discloses that
[wjhile the preceding exemplary embodiments have focused on
a milling guide system for the tibial articular surface in the
placement of total knee joint prosthesis, it will be understood that
the techniques described are applicable to unicondylar knee
replacements as1 well as other joints and other bone surfaces, the
instrument and component geometry being adjusted accordingly.
Bertin 8:60—66 (emphasis added). We also note that Burdulis discloses the
devices for articular resurfacing may be used on joints such as a femur,
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Application 12/241,002
“knee, shoulder, hip, vertebrae, elbow, ankle, wrist etc.” See, e.g., Burdulis
2, 3, 7, 9. Appellants’ arguments do not identify error by the Examiner.
For the reasons above, the rejection of claim 4 is sustained. Claim 19
falls with claim 4.
DECISION
For the above reasons, the Examiner’s rejection of claims 1—6, 13—16,
19, and 20 is AFFIRMED.
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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