Ex Parte Katrana et al

Patent Trial and Appeal Board

Nov 14, 2016

13089595 (P.T.A.B. Nov. 14, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/089,595 04/19/2011
104326 7590 11/16/2016
Schwegman Lundberg & Woessner I Zimmer
P.O. Box 2938
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Nicholas J. Katrana
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.
5394.884US 1 1754
EXAMINER
COLEY, ZADE JAMES
ART UNIT PAPER NUMBER
3775
NOTIFICATION DATE DELIVERY MODE
11/16/2016 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):
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 NICHOLAS J. KATRANA, NATHAN A. WINSLOW,
and JOHN M. McDANIEL
Appeal2014-005802
Application 13/089,595
Technology Center 3700
Before LINDA E. HORNER, ERIC C. JESCHKE, and
PAUL J. KORNICZKY, Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Nicholas J. Katrana et al. (Appellants) seek our review under
35 U.S.C. § 134 of the Examiner's decision, as set forth in the Final Action,
dated July 17, 2013, ("Final Act."), rejecting claims 1-25 and 30-33. 1
Claims 26-29 are canceled. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Appellants identify the real party in interest as Biomet Manufacturing,
LLC. Appeal Br. 3.
Appeal2014-005802
Application 13/089,595
CLAIMED SUBJECT MATTER
Appellants' claimed subject matter relates to "patient-specific
instruments for reducing fractures and facilitating internal fixation." Spec.,
para. 1. Claims 1, 16, and 30 are the independent claims on appeal. Claim 1
is reproduced below.
1. An instrument for internal bone fracture fixation
compnsmg:
a first elongated shaft having a first distal portion; and
a first patient-specific bone holder coupled to the first
distal portion, the first bone holder having a three-dimensional
curved and patient-specific bone engagement surface designed
during a preoperative plan based on a medical scan of a patient
and configured to match as an inverse surface to an outer surface
of a first bone fragment of a fractured bone of the patient.
EVIDENCE
The Examiner relied upon the following evidence:
Gundlapalli
Robie
Schoenefeld
Abou El Kheir
Turner
us 5,697,933
us 6,159,217
US 2008/0114370 Al
US 2008/0287926 Al
WO 2009/001109 Al
REJECTIONS
The Final Action included the following rejections:
Dec. 16, 1997
Dec. 12, 2000
May 15, 2008
Nov. 20, 2008
Dec. 31, 2008
1. Claims 1-7, 9-11, 13-17, 19, 20, 22-25, and 30 under 35 U.S.C.
§ 102(b) as anticipated by Turner. 2
2 The Examiner's statement of the ground of rejection in the Final Action
includes claim 21; however, the detailed explanation that follows contains
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Application 13/089,595
2. Claims 8, 32, and 33 under 35 U.S.C. § 103(a) as unpatentable
over Turner and Schoenefeld.
3. Claims 12 and 18 under 35 U.S.C. § 103(a) as unpatentable over
Turner and Gundlapalli.
4. Claim 21 under 35 U.S.C. § 103(a) as unpatentable over Turner
and Robie.
5. Claim 31 under 35 U.S.C. § 103(a) as unpatentable over Turner
and Abou El Kheir.
ANALYSIS
First Ground of Rejection
Each of independent claims 1, 16, and 30 calls for a patient-specific
bone holder having "a three-dimensional curved and patient-specific bone
engagement surface designed during a preoperative plan based on a medical
scan of a patient and configured to match as an inverse surface to an outer
surface of a first bone fragment of a fractured bone of the patient." Appeal
Br. 22, 25, and 27 (Claims App.). The Examiner found that Turner discloses
an instrument capable of being used for internal bone fracture fixation
having a patient-specific bone holder 12 with a three-dimensional curved
and patient-specific bone engagement surface. Final Act. 2, 4, and 5 (citing
Turner, Figs. 1, 3). The Examiner construed "designed during a
preoperative plan based on a medical scan of a patient" as a product-by-
no discussion of claim 21. Final Act. 2-6. As such, we understand the
inclusion of claim 21 in the first ground of rejection to be a typographical
error by the Examiner.
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Application 13/089,595
process limitation and found that the bone engagement surface of Turner is
"capable of being designed [as claimed]." Id. at 2, 4, and 5-6. The
Examiner further found that the bone holder of Turner is "capable of
matching as an inverse surface to an outer surface of a first bone fragment of
a fractured bone of the patient." Id. at 2-3, 4, and 6 (citing Turner, Figs. 1,
3, 8a, 9, and 14) (finding that this limitation "depends on how the fractured
bone is shaped" and "bones can come in a very wide variety of shapes and
sizes"); see also Ans. 2 (finding that "Turner clearly designs the device to
match the bone of a specific patient" and that "[t]he clamping jaws have a
concave surface that matches an inverse surface (i.e.[,] a convex surface) of
a bone") (citing Turner, para. 104, Figs. 8-10, and 13). 3
Appellants contend that the Examiner erred because "Turner's
instrument has jaws 12, 13 for clamping an intact femoral neck 54" and that,
"[a]s can be clearly seen in FIG. 12 of Turner, the jaws are not patient-
specific, i.e., the jaws are not custom made for a specific patient and do not
have a patient-specific bone engagement surface configured to match as an
inverse surface to an outer surface of a first bone fragment of a fractured
bone of the patient." Appeal Br. 10, 11. Appellants contend that
"[ m ]atching the surface as an inverse is not a matter of just matching size
and overall shape but also matching the peculiarities of the bone surface of a
3 The Examiner cited to the paragraph numbers found in the pre-grant
publication of the U.S. counterpart application to Turner (US 2011/0257657
Al, published October 20, 2011). We cite to the U.S. publication in this
Decision for consistency with the record.
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Appeal2014-005802
Application 13/089,595
specific patient, such as idiosyncratic protrusions, dimples, osteophytes and
the like." Id. at 11.
With regard to examination of product-by-process claim limitations,
the Manual of Patent Examining Procedure (MPEP) provides:
The structure implied by the process steps should be considered
when assessing the patentability of product-by-process claims
over the prior art, especially where the product can only be
defined by the process steps by which the product is made, or
where the manufacturing process steps would be expected to
impart distinctive structural characteristics to the final product."
MPEP § 2113(1) (citing In re Garnero, 412 F.2d 276, 279 (CCPA 1979));
see also MPEP § 2113 (II) (describing that the examiner must "provide a
rationale tending to show that the claimed product appears to be the same or
similar to that of the prior art, although produced by a different process").
Appellants' Specification describes that "[t]he patient-specific
instrument components have an engagement surface that is made to
conformingly contact and match a three-dimensional image/model of the
patient's bone surface (with or without cartilage or other soft tissue), by the
computer-assisted image methods." Spec., para. 22; see also id. at para. 40
(describing that the bone-engaging surface is designed to "closely match, as
mirror or inverse image, the outer surfaces of the corresponding bone
fragments and/or bone portions"). We understand the "patient-specific bone
engagement surface" to be defined in the claims by the process step used to
make it, e.g., it is "designed during a preoperative plan based on a medical
scan of the patient." This surface is further defined in the claims by the
resulting structure of the design process, which provides an engagement
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Application 13/089,595
surface that is "configured to match as an inverse surface to an outer surface
of a first bone fragment of a fractured bone of the patient." As such, the
structure implied by the process step and explicitly recited in the claims is a
bone engagement surface that is made to conformingly contact and match a
three-dimensional outer surface of the patient's bone fragment.
Turner does not disclose the claimed "patient-specific bone
engagement surface." Turner is directed to "devices for aligning guide wires
with respect to bones." Turner, para. 1. Turner's device 1 is in the form of a
scissor clamp 2 with two arms 3, 4, each arm having a jaw 12, 13 disposed at
its distal end for attaching the device to a bone. Turner, para. 77, Fig. 1. In
use, the jaws 12, 13 are attached to the neck of the femur, for example,
which results in an alignment guide being naturally aligned with a center
point of the neck of the femur for placement of the guidewire. Turner,
para. 89, Fig. 11. Figure 12 of Turner is reproduced below:
FIG.12
"FIG. 12 shows a cross-section through the neck (54) of a femur (53), with
the jaws (12, 13) of the device attached to the neck (54) in an opposed
position." Turner, para. 90 (emphasis omitted). As can be seen in Figure
12, the inner surface of each jaw 12, 13 that comes in contact with the femur
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Application 13/089,595
is not configured to match as an inverse surface to an outer surface of the
femur. As such, Turner does not disclose a "patient-specific bone
engagement surface designed during a preoperative plan based on a medical
scan of a patient and configured to match as an inverse surface to an outer
surface of a first bone fragment of a fractured bone of the patient" as called
for in claims 1, 16, and 30. For these reasons, we do not sustain the
rejection of independent claims 1, 16, and 30, and their dependent claims 2-
7, 9-11, 13-15, 17, 19, 20, and 22-25 under 35 U.S.C. § 102(b) as
anticipated by Turner.
Second through Fifth Grounds of Rejection
The remaining grounds of rejection are based on the same finding as
to Turner's disclosure that we found deficient in the first ground of rejection.
Final Act. 6-9. Thus, we likewise do not sustain the remaining grounds of
rejection under 35 U.S.C. § 103(a): of claims 8, 32, and 33 as unpatentable
over Turner and Schoenefeld, of claims 12 and 18 as unpatentable over
Turner and Gundlapalli, of claim 21 as unpatentable over Turner and Robie,
and of claim 31 as unpatentable over Turner and Abou El Kheir.
DECISION
The decision of the Examiner to reject claims 1-25 and 30-33 is
REVERSED.
REVERSED
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