Ex Parte 6623486 et al

Patent Trial and Appeal Board

Aug 19, 2013

95000468 (P.T.A.B. Aug. 19, 2013)

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.
90/009,378 01/08/2009 6623486 SYNT-0703 5757
53443 7590 08/19/2013
WOODCOCK WASHBURN LLP
CIRA CENTRE, 12TH FLOOR
2929 ARCH STREET
PHILADELPHIA, PA 19104-2891
EXAMINER
REIP, DAVID OWEN
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
08/19/2013 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
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.
95/000,468 05/08/2009 6623486 SYNT-0712 2083
53443 7590 08/19/2013
WOODCOCK WASHBURN LLP
CIRA CENTRE, 12TH FLOOR
2929 ARCH STREET
PHILADELPHIA, PA 19104-2891
EXAMINER
REIP, DAVID OWEN
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
08/19/2013 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
____________________

SMITH & NEPHEW, INC.
Requester, Cross-Appellant, Respondent
v.
SYNTHES (U.S.A.)
Patent Owner, Appellant, Respondent
____________________

Appeal 2013-002114
Reexamination Control 95/000,468 and 90/009,378
1

Patent US 6,623,486 B1
2

Technology Center 3900
____________________

Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON and
DANIEL S. SONG, Administrative Patent Judges.

SONG, Administrative Patent Judge.

DECISION ON APPEAL

1
These reexamination proceedings were merged by Decision, Sua Sponte, to
Merge Reexamination Proceedings, mailed July, 10, 2009. The citations in
this decision are to the record of inter partes Reexamination Control
95/000,468 unless otherwise indicated.
2
Issued September 23, 2003 to Weaver et al. (hereinafter "'486 patent").
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Claims 1-18 are subject to reexamination (RAN
3
1). The Patent
Owner appeals from the Examiner's Final Rejection of claims 1-13, 16 and
17 under 35 U.S.C. §§ 134, 306 and 315 (2002), the appeal of claims 14, 15
and 18 having been withdrawn (ABPO 1). The Requester also cross-appeals
under 35 U.S.C. §§ 134 and 315, the Examiner's non-adoption of certain
proposed rejections for claims 10-13 (CABR 2). We have jurisdiction of the
appeal under 35 U.S.C. §§ 134, 306 and 315. An oral hearing with the
Patent Owner's representative and the Respondent's representative was held
before the Patent Trial and Appeal Board on April 3, 2013, a transcript of
which has been entered into the electronic record.
The '486 patent is presently involved in the following infringement
litigation proceedings, both of which have been stayed pending the
conclusion of the present reexamination proceeding (ABPO 1):

3
The following abbreviations for certain documents in the record are used
herein the documents as follows:
1. Right of Appeal Notice = RAN
2. Appeal Brief of Patent Owner = ABPO
3. Rebuttal Brief of Patent Owner in response to Examiner's
Answer = Reb. Br. PO
4. Cross-Appeal Brief of Requester = CABR
5. Respondent Brief of Requester in response to Appeal Brief of
Patent Owner = Res. Br. R

We also note that because the Examiner's Answer merely incorporates the
RAN by reference, we cite to the RAN herein.
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1. Synthes (U.S.A.) v. Smith & Nephew, Inc., Civil Action No. 03-
0084 (E.D. Pa); and
2. Synthes (U.S.A.) v. G.M. Dos Reiss JR Ind. Com De Equip
Medico, Civil Action No. 3:07 cv 309 (S.D. Cal.).
In the present reexamination proceeding, 93 grounds of rejections
were proposed by the Requester. The Examiner adopted 86 of these
proposed grounds (Grounds 1, 2, 6, 8, 9, 11-85,
4
87-92; RAN 14-15). The
Patent Owner appeals 77 of the adopted grounds that reject one or more of
claims 1-13, 16 and 17 which are rejected under Grounds 1, 2, 8, 9, 11-17,
19-32, 34-37, 39-41, 43-45, 47-51, 53-61, 64-85 and 87-92
5
(ABPO 1). Of
the proposed grounds of rejection not adopted by the Examiner, Grounds
12,
6
86 and 93 are cross-appealed by the Requester (CABR 2).
In addition to the various briefs submitted in support of its appeal and
in response to the cross-appeal, the Patent Owner also relies on Declarations
of Drs. Turen and Parsons, and Mr. Haag, together with Exhibits referred to
therein. Similarly, in addition to the various briefs submitted in support of
its cross-appeal and in response to the Patent Owner's appeal, the Requester
also relies on the Declarations of Mr. Donoghue and Dr. Marsh.
We AFFIRM the Examiner's rejections with respect to the Patent
Owner's appeal, and do not reach the Requester's cross-appeal.

4
Ground 12 adopted only with respect to claim 11 (RAN 23-24).
5
The appeal of claim(s) 14, 15 and 18 that were rejected under Grounds 6,
18, 33, 38, 42, 46, 52, 62 and 63 was withdrawn by the Patent Owner
(ABPO 1).
6
Ground 12 cross-appealed only with respect to claim 12.
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BACKGROUND
The subject '486 patent issued from a continuation application of an
application that issued as U.S. Patent No. 7,128,744
7
which was the subject
of the Board's
8
decision in an inter partes reexamination appeal
9
involving
the same parties. Smith & Nephew, Inc. v. Synthes, 2012 WL 169750
(BPAI) (hereinafter "Board Decision" or "Board Dec."). The Board
Decision was appealed to the Court of Appeals for the Federal Circuit which
recently rendered a decision reversing the Board. Smith & Nephew, Inc. v.
Rae and Synthes, 2013 WL 3388454 (Fed. Cir. 2013). Because some of the
issues raised in the present appeal were addressed or overlap with those in
Smith & Nephew v. Rae and Synthes, we discuss the Board Decision and the
Court's reversal prior to addressing the present appeal.

Board Decision
In the appeals involving the parent U.S. Patent No. 7,128,744
(hereinafter "'744 patent"), two of the main issues were:
1. Whether the Examiner erred in concluding that it would
have been obvious to one of ordinary skill in the art to modify a
condylar buttress plate having a head portion that includes
unthreaded bone anchor holes as described in K982222, Koval
or Synthes Catalog so as to only provide holes having a
threaded portion in the head portion of the buttress plate.

7
Issued to Weaver et al. on Oct. 31, 2006.
8
Formerly Board of Patent Appeals and Interferences.
9
Appeal No. 2011-010701.
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2. Whether the Examiner erred in concluding that it would
have been obvious to one of ordinary skill in the art to modify a
condylar buttress plate as described in K982222, Koval or
Synthes Catalog to provide holes in the shaft portion of the
buttress plate having a threaded portion as well as non-threaded
holes.
('744 Board Dec. *3).

As to "Issue 2," the Board affirmed the Examiner's rejections
concluding that it would have been obvious to one of ordinary skill to
modify a condylar buttress plate as described in K982222, Koval or Synthes
Catalog to provide holes in the shaft portion of the buttress plate having a
threaded portion as well as non-threaded holes ('744 Board Dec. *10).
However, as to "Issue 1," the Board reversed various rejections of
claims requiring the bone plates to have a head with only threaded holes
which are conically tapered, concluding that the articulated rationale
10
for

10
The Examiner adopted the rejection proposed by the Requester, the
following articulated rationale being representative:
[I]t would be obvious to one of ordinary skill in the art to
modify K982222 to include a head portion that includes only
threaded, conically tapered holes since such a configuration is
nothing more than one of numerous configurations one of
ordinary skill would find obvious for the intended use given the
known advantages of using threaded holes in the head portion
of a plate. Haas, for example, discloses a bone plate that has a
head portion that includes all threaded holes. … The plate holes
of Haas are all threaded and conically tapered …. It would be
obvious to modify K982222 with Haas based on the advantages
of locked screws as discussed in Haas (e.g., "the angularly
stabile, screw/plate connection which is achieved by means of
the outer thread of the screw head and an internal threading of
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modifying condylar buttress plates so as to provide a head with only
threaded holes lacked adequate rational underpinnings and was likely based
on impermissible hindsight because provision of non-threaded holes in the
head allowed for generation of compression which is an important function
of such plates (id. at *7). The Board also stated that the evidence was
"insufficient to establish that the tapered holes disclosed in Haas are usable
to impart compression," or to establish that such holes "were one of the
known hole configurations that were suitable for use with both non-locking
and locking screws." (Id. at *7-*8). The Requester appealed the Board
Decision to the Federal Circuit.

CAFC Decision: Smith & Nephew, Inc. v. Rae and Synthes
Upon appeal by the Requester, the Court reversed the Board Decision
and held that "the examiner correctly ruled that disputed claims would have
been obvious." 2013 WL 3388454 *8. In its decision, the Court rejected the
Board's analysis and stated the following:
1. If a physician regarded it as preferable to have
stabilization rather than compression in the head portion of a
bone plate, an obvious solution would have been to use more
threaded holes and locking screws in that part of the plate. (Id.
at *4).

2. [A] person of ordinary skill would not have had
to use a screw with a 'rounded-bottom head' that would stick

the plate hole, thus prohibiting a varying direction the [sic]
screw" (p. 341)).
(Board Dec. at *6, quoting Request for Inter Partes Reexamination,
Exhibit E, 4).
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out from the plate. Instead, a conically shaped screw could
sit in the Haas holes without any risk of protrusion. The
'744 specification states, as a general proposition, that 'any
surgical screw that has a non-threaded head ... of an appropriate
size and geometry for select plate holes of the bone plate can be
used' in the claimed bone plate. '744 patent, col. 4, ll. 20–22.
The patent thus suggests the choice of any appropriate screw
design rather than limiting the choice to a screw that would sit
too high in a conical hole. (Id. at *5).

3. [T]he Board's reliance on the fact that the partially
threaded holes in the ′686 patent are only partly conical (and
partly cylindrical) does not undermine the '744 patent's
admission that partially threaded holes, regardless of their
shape, could provide compression. Neither the Board nor
Synthes has argued that there is anything about the Haas fully
conical shape that would suggest that a standard, non-locking
screw could not have been used in such a hole to achieve
compression. (Id. at *5).

4. The patent confirms what common sense suggests: a
person of skill could adjust a plate hole's geometry—whether
conical, cylindrical, or otherwise—to fit any standard screw
without sacrificing compression. (Id. at *5).

5. The ′744 specification's description of the '686 patent
therefore discloses that the prior art used non-locking screws in
threaded holes. Because that prior art reference demonstrated
that non-locking screws could achieve compression in either
type of hole, the motivation to combine the Haas holes with the
condylar plates was clear: The use of threads in all of the holes
would offer the advantage of added flexibility for the surgeon,
who could choose to use locking or non-locking screws in any
of the holes in the head portion of the plate. (Id. at *6).

6. The Board discounted [DRP and LRP] references on
the ground that the examiner had not relied on them as a basis
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for his rejections. The examiner, however, incorporated Smith
& Nephew's arguments by reference, including its discussion of
those two references. The references were clearly probative as
to whether it was known at the time of the invention that non-
locking screws could be used in threaded holes. (Id. at *6).

Thus, the court made clear in its decision that modifying condylar
buttress plates of K982222 and Koval that have a head portion with both
threaded and non-threaded holes so as to provide only threaded holes as
shown in Haas would have been obvious to one of ordinary skill in the art.

THE CLAIMED INVENTION
Claims 1-13, 16 and 17 on appeal are directed to a bone plating
system which is used to repair a bone fracture, and a method for bone
fracture fixation. Independent claims 1, 10, 16 and 17 read as follows
(ABPO, Claims App'x., paragraph formatting and emphasis added):
1. A bone plating system for fixation of bone comprising:
a bone plate having:
an upper surface;
a bone-contacting surface;
at least one first hole passing through the upper
and bone-contacting surfaces and having a thread; and
at least one second hole passing through the upper
and bone-contacting surfaces;
a first screw having a shaft with a thread for engaging
bone and a head with a thread configured and dimensioned to
mate with the thread of the first hole; and
a second screw having a shaft with a thread for engaging
bone and a head, wherein the first and second screws remain
seated in their respective holes for substantially as long as the
bone plate is implanted,
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wherein the bone plate includes a plurality of first and
second holes, and a corresponding plurality of first and second
screws are provided, and
wherein the bone plate includes a head portion
configured and dimensioned to conform to a metaphysis of a
bone and a shaft portion configured and dimensioned to
conform to a diaphysis of a bone and the head portion has only
first plate holes.

10. A method for fracture fixation of bone comprising the
steps of:
reducing the fracture to bring bone fragments in close
apposition;
compressing a bone plate against the bone with at least
one first fastener to hold the fracture reduction; and
securing at least one second fastener at a fixed angular
relationship to the bone plate,
wherein the at least one first fastener is inserted before
the at least one second fastener and the at least one first
fastener and the at least one second fastener remain in bone for
substantially as long as the bone plate is implanted.

16. A bone plating system for fixation of bone comprising:
a bone plate having:
an upper surface;
a bone-contacting surface;
at least one first hole passing through the upper
and bone-contacting surfaces and having a thread; and
at least one second hole passing through the upper
and bone-contacting surfaces;
a first screw having a shaft with a thread for engaging
bone and a head with a thread configured and dimensioned to
mate with the thread of the first hole; and
a second screw having a shaft with a thread for engaging
bone and a head, wherein the first and second screws remain
seated in their respective holes for substantially as long as the
bone plate is implanted,
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wherein the bone plate includes a plurality of first and
second holes, and a corresponding plurality of first and second
screws are provided, and
wherein the bone plate includes a head portion
configured and dimensioned to conform to a metaphysis of a
bone and a shaft portion configured and dimensioned to
conform to a diaphysis of a bone and wherein the head portion
has a curved surface, includes an anterior fork substantially
parallel to an anterior side of the shaft portion, and includes a
posterior fork extending out from a posterior side of the shaft
portion.

17. A bone plating system for fixation of bone comprising:
bone plate having:
an upper surface;
a bone-contacting surface;
at least one first hole passing through the upper
and bone-contacting surfaces and having a thread; and
at least one second hole passing through the upper
and bone-contacting surfaces;
a first screw having a shaft with a thread for engaging
bone and a head with a thread configured and dimensioned to
mate with the thread of the first hole; and
a second screw having a shaft with a thread for engaging
bone and a head, wherein the first and second screws remain
seated in their respective holes for substantially as long as the
bone plate is implanted,
wherein the bone plate includes a plurality of first and
second holes, and a corresponding plurality of first and second
screws are provided, and
wherein the bone plate includes a head portion
configured and dimensioned to conform to a metaphysis of a
bone and a shaft portion configured and dimensioned to
conform to a diaphysis of a bone and wherein the shaft portion
has both first and second plate holes.

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APPEAL OF THE PATENT OWNER
The Rejections
In view of the large number of rejections, we do not reproduce the
rejections herein but point to the proposed rejections as set forth in the Right
of Appeal Notice (RAN 5-14). However, the rejections can be generally
categorized as follows:
1. Rejections principally based on K982222
11
(Grounds 28-32, 34-
37, 39-41, 43-45, 47).
2. Rejections principally based on Zimmer
12
(Grounds 65-80).
3. Rejections principally based on Koval
13
(Grounds 89-92).
4. Rejections principally based on Mückter
14
(Grounds 21-27).
5. Rejections principally based on Distal Radius Plate
15

(Grounds 81-85, 87, 88).
6. Rejections principally based on Schuhli Guide
16
(Grounds 1, 2,
8, 48-51, 53-61, 64).

11
Summary of Safety and Effectiveness Information, No. K982222,
August 26, 1988.
12
Periarticular Plating System (Advertisement), 12 J. of Ortho. Trauma 5,
June/July 1998.
13
Koval, K., et al., Distal Femoral Fixation: A Biomechanical Comparison
of the Standard Condylar Buttress Plate, a Locked Buttress Plate, and the
95-Degree Blade Plate, 11 J. of Orthopaedic Trauma 7, pp. 521-524,
October, 1997.
14
Patent WO 99/25266 issued to Mückter
15
Synthes, The Titanium Distal Radius Plate Technique Guide (hereinafter
"DRP") 1997.
16
Synthes, Schuhli Technique Guide, 1995 (hereinafter "Schuhli Guide").
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7. Rejections principally based on Kassab
17
(Grounds 13-17, 19,
20).
8. Rejection principally based on Haag
18
(Ground 9).
9. Rejections principally based on Locking Reconstruction Plate
19

(Grounds 11, 12).

Issues
The dispositive issues on appeal are as follows:
1. Whether the Examiner erred in concluding that it would have
been obvious to one of ordinary skill in the art to modify a condylar buttress
plate having a head portion that includes unthreaded bone anchor holes as
described in K982222 or Koval so as to only provide holes having a thread
in the head portion.
2. Whether the Examiner erred in concluding that providing a
bone plate with an anterior fork substantially parallel to an anterior side of
the shaft portion would have been an obvious variation, and that such a fork
is disclosed in the plate of the Synthes Catalog.
3. Whether the Examiner erred in concluding that it would have
been obvious to one of ordinary skill in the art to modify a condylar buttress

17
Kassab, S.S., et al., Patients Treated for Nonunion with Plate and Screw
Fixation and Adjunctive Locking Nuts, 347 Clinic. Ortho. And Related
Research, pp. 86-92, Feb. 1998.
18
Patent US 5,976,141 issued to Haag.
19
Synthes Maxillofacial, The Locking Reconstruction Plate Technique
Guide (hereinafter "LRP") 1997.
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plate as described in K982222 or Koval to provide threaded holes in the
shaft portion of the buttress plate as well as non-threaded holes.
4. Whether the Examiner erred in finding that the method of claim
10 is disclosed in Kassab.
5. Whether the Examiner erred in concluding that the method of
claim 10 would have been obvious to one of ordinary skill in the art based
on Schuhli Guide in view of Klaue '823.

Analysis
Apparatus Claims 1-9, 16 and 17
As to the apparatus claims 1-9, 16 and 17, sixty-eight different
grounds of rejections have been adopted by the Examiner and are appealed
by the Patent Owner. While we have considered all of these appealed
grounds of rejections and arguments of the parties submitted, we limit our
decision to certain rejections based on K982222 and Koval as they formed
the basis for the rejections in the appeal of the parent '744 patent. Prior art
references K982222 and Koval each disclose a condylar buttress plate that
includes a head portion with threaded holes, but also includes two holes that
are not threaded (K98222 Description; Koval Abstract, Discussion, Fig. 1).

Claims 1-9
Grounds 30-32 reject apparatus claims 1-9 based on K982222 in view
of Haas, as well as various tertiary prior art references for certain claims, by
modifying the K982222 plate so as to provide only threaded holes on the
head portion thereof (RAN 7-8, 14). Grounds 89-92 similarly reject
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apparatus claims 1-9 based on the combination of Koval and Haas, as well
as various tertiary prior art references for certain claims (RAN 13-14). The
secondary reference Haas discloses a "Less Invasive Stabilization System"
plate in which all of the holes are conical and threaded to receive screws
with threaded heads (Haas, pp. 340-341, Diags. 3 and 4).
As to independent claim 1, the dispute centers on the limitation that
"the head portion has only first plate holes" which are recited to be threaded
("at least one first hole passing through the upper and bone-contacting
surfaces and having a thread"). The Examiner rejected this claim based on
the combination of K982222 and Haas, adopting the proposed rejection set
forth by the Requester which stated:
To the extent that K982222 does not disclose a head portion
having only first plate holes, it would be obvious to one of
ordinary skill in the art modify K982222 to include a head
portion that includes only first holes since such a configuration
is nothing more than one of numerous configurations one of
ordinary skill would find obvious for the intended use given the
known advantages of using threaded, first plate holes in the
head portion of a plate. Haas, for example, discloses a bone
plate that has a head portion that includes all threaded holes. …
The plate holes of Haas are all threaded, therefore, the head has
only first plate holes. Based on the disclosure of Haas, it would
have been obvious to one of ordinary skill in the art to modify
K982222 to include all threaded holes in the head portion, as
taught by Haas, to achieve the advantages of using a locking
screw arrangement (e.g., based on the disclosure of Haas
regarding the advantages of using a locking screw arrangement
so that there is "no longer any compression pressures on the
periosteum and circulation remains unimpeded." (Summary).
(Request for Inter Partes Reexamination, Exhibit U, pp. 3-4; see also
pp. 75-76).
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The rationale for the rejections based on the combination of Koval
and Haas is substantively similar (see Request for Ex Partes Reexamination
pp. 48; Exhibit C, pp. 12). Thus, the issue raised with respect to these
grounds and the articulated rationale substantively mirrors that of the related
appeals of the parent '744 patent noted above (see supra, fn. 10).
The Patent Owner's submitted arguments and evidence in support of
patentability of independent claim 1, and claims 2-9 that ultimately depend
therefrom, are substantively the same as those presented and addressed by
the Court in Smith & Nephew v. Rae and Synthes, 2013 WL 3388454. In
particular, the Patent Owner argues that there is no motivation to modify the
plates in K982222 or Koval to have a head portion with only threaded bone
anchor holes because the unthreaded holes function to allow for fracture
reduction and compression, and their removal would render the plates
inoperable for their intended purpose (ABPO 25-39).
These arguments and evidence relied upon by the Patent Owner, as
well as the analysis by the Board in agreement thereto, were found to be
unpersuasive and erroneous by the Federal Circuit court. Smith & Nephew
v. Rae and Synthes, 2013 WL 3388454, **4-6 (see excerpts of the Court's
decision reproduced supra). The court held that it would have been obvious
to modify condylar buttress plates of K982222 or Koval to provide a head
having only threaded holes disclosed in Haas (id.).
This case differs from Smith & Nephew v. Rae and Synthes because in
this appeal before the Board, Synthes has relied upon secondary
considerations of commercial success to establish the non-obviousness of the
claimed subject matter. In the latter case, the court did not address the
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evidence of commercial success in its decision because unlike in the appeal
to the Board, Synthes did not rely on such evidence for patentability (Smith
& Nephew v. Rae and Synthes, 2013 WL 3388454, *7, fn. 7 ("Synthes has
not relied on any objective indicia of non-obviousness, such as commercial
success, to buttress its case.")).
Therefore, we consider the obviousness of the claims at issue in view
of the proffered evidence of nonobviousness. For the reasons discussed
infra under the heading "Commercial Success," we agree with the Examiner
that the evidence does not adequately demonstrate non-obviousness of the
claimed invention because the evidence is inadequate to establish nexus
between the claimed invention and the commercial success.
Correspondingly, the Examiner's rejections of independent claim 1
and dependent claims 2-9 in Grounds 30-32 (K982222 and Haas) and in
Grounds 89-92 (Koval and Haas), are affirmed.

Claim 16
Independent claim 16 is drawn to a bone plating system for fixation of
bone. The claim comprises a bone plate and recites, inter alia, that the bone
plate has the following features:
wherein the head portion has a curved surface, includes an
anterior fork substantially parallel to an anterior side of the
shaft portion, and includes a posterior fork extending out from a
posterior side of the shaft portion.

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In addition, unlike independent claim 1, claim 16 does not recite that
the head portion has only threaded holes. Claim 16 stands rejected under,
inter alia, the following grounds:
Ground 30 based on K982222 in view of Haas;
Ground 47 based on K982222 in view of Synthes Catalog; and
Ground 89 based on Koval in view of Haas.
As to Grounds 30 and 89, the position of the Examiner as articulated
by the Requester is that one of ordinary skill would appreciate such a fork
structure would be an obvious variation to conform to the condyle structure
of the femur (RAN 7, 13; see, e.g., Request for Inter Partes Reexamination,
Exhibit U; see also ABPO 45).
The Patent Owner argues that "this feature of claim 16 is not simply
'an obvious variation' useful to conform the plate to the condyle structure."
(ABPO 46). The Patent Owner disagrees with the Examiner's assertion and
states, "[t]he parallel anterior fork does nothing for conforming the plate to
the curved condyle surface" and such conforming of the plate "has nothing
whatsoever to do with the parallel relationship between the anterior fork of
the head portion and the anterior side of the plate shaft." (Id., emphasis in
original). According to the Patent Owner, while the specification of the '486
patent "fails to disclose a function for this parallel anterior-fork limitation,"
this feature "assist[s] in aligning the femur shaft because the plate is used as
a fracture reduction aid" (Reb. Br. PO 32), such benefit apparently not being
recognized in the art.
We are not persuaded. Firstly, the Patent Owner does not direct our
attention to evidence, such as testimony of an expert, as to how an anterior
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feature that is "substantially parallel to an anterior side" functions to assist
the alignment of the femur shaft. In re Schulze, 346 F.2d 600, 602 (CCPA
1965) (Mere argument is no substitute for such evidence). It is not apparent
to us, nor has the Patent Owner adequately explained, how a "substantially
parallel" anterior fork would further "assist" a surgeon in aligning the femur
shaft considering the head portion of the plate must conform to the condyle
surface of the bone thereby determining the position of the shaft portion to
which the femur shaft must be secured. To the extent that the anterior side
assists the alignment of the femur shaft by facilitating proper positioning of
the head portion on the condyle structure, this is consistent with the
Requester and the Examiner's position that shaping the head of the plate to
properly conform to the condyle structure would be an obvious variation and
design choice.
As to Ground 47 which is based on the combination of K982222 and
Synthes Catalog, the Patent Owner asserts that the Examiner's finding that
Synthes Catalog discloses "an anterior fork substantially parallel to an
anterior side of the shaft portion" is erroneous (ABPO 46). The Patent
Owner's Appeal Brief includes an annotated Figure 7 of the '486 patent (id.
at 46) and the photograph of a condyle buttress plate in Synthes Catalog
which is purported to show that the anterior fork of Synthes Catalog is at an
angle to the anterior side instead of being parallel (id. 46-47).
However, we initially note that claim 16 does not recite "parallel" but
instead, recites "substantially parallel." Furthermore, the Patent Owner's
annotation of Figure 7 submitted in its Appeal Brief is contrary to the
specification of the '486 patent. Fork 68 annotated and relied upon by the
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Patent Owner as corresponding to the recited anterior fork is actually
identified in the specification of the '486 patent as the "posterior fork 68"
while fork 64 is identified in the specification as the "anterior fork 64." (See
col. 6, ll. 18-22; Fig. 7). In particular, the specification states "[h]ead
portion 60 includes an anterior fork 64 substantially parallel to an anterior
side 66 of shaft portion 62." (Id.). Thus, the anterior fork of the plate in the
Synthes Catalog is "substantially parallel" to the anterior side to the extent
that the anterior fork 64 of the '486 patent is described to be substantially
parallel.
Finally, for the reasons discussed infra under the heading
"Commercial Success," the evidence of commercial success submitted by
the Patent Owner does not establish sufficient nexus between the evidence
and the claimed invention so as to persuasively demonstrate non-
obviousness of the claimed invention. Therefore, we agree with the
Examiner and the Requester that the recited limitation is an obvious
variation and design choice, and further agree that Synthes Catalog discloses
the limitation at issue. Hence, we affirm the Examiner's rejection of claim
16 under Ground 30 (K982222 and Haas), Ground 47 (K982222 and
Synthes Catalog) and Ground 89 (Koval and Haas).

Claim 17
Claim 17 cites, inter alia, a bone plate "wherein the shaft portion has
both first and second plate holes," that is, a shaft portion having both
threaded and unthreaded holes. Unlike independent claim 1, claim 17 does
not recite that the head portion has only threaded holes. This claim stands
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rejected, inter alia, under Ground 30 based on K982222 in view of Haas,
and under Ground 89 based on Koval in view of Haas.
This issue substantively mirrors that of "Issue 2" in the related appeal
at the Board with respect to the parent '744 patent reproduced supra (Board
Dec. **9-11). In this regard, the Patent Owner's submitted arguments that
"none [of the prior art] ever suggested modifying the shaft portion DCU
holes," and that such replacement would result in loss of the functions
provided by the DCU holes (ABPO 47-48) have been already addressed in
the Board Decision with respect to the appeal regarding the parent '744
patent. Specifically, in discussing modification of the shaft portion of the
condylar buttress plates of K982222 and Koval to also provide threaded
holes of Hass (together with the existing unthreaded holes), we concluded
that:
In our view, it would have been obvious to one of
ordinary skill in the art that the benefit of angular stabilization
offered by providing threaded holes in the head portion of the
bone plate would be similarly applicable to the shaft portion of
the bone plate for reasons and benefit of being angular stabile
as articulated in Haas (See Haas, 340-341; see also Decl. of
Marsh, ¶¶ 77, 79-80, 83). Further, we observe that the
proposed modification is not to only provide threaded holes in
the shaft of the prior art condylar buttress plates. Rather, the
suggested modification is to provide both non-threaded and
threaded holes in the shaft. Hence, the compression between
the condylar buttress plate and the bone can be attained using
the non-threaded holes. … Therefore, based on the evidence
before us, it would have been obvious to one of ordinary skill in
the art that by providing both unthreaded as well as at least
partially threaded holes in the shaft portion of the prior art
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condylar buttress plates, the angular stabile connection of the
screw/plate connection as taught in Haas can be attained.
(Board Dec. *10).
Finally, for the reasons discussed infra under the heading
"Commercial Success," the evidence of commercial success submitted by
the Patent Owner does not establish sufficient nexus between the evidence
and the claimed invention so as to persuasively demonstrate non-
obviousness of the claimed invention. Hence, in view of the above, we
affirm the Examiner's rejection of claim 17 under Ground 30 (K982222 and
Haas) and Ground 89 (Koval and Haas).

Remaining Grounds
Each of the apparatus claims 1-9, 16 and 17 have been rejected under
at least two separate grounds. Hence, the other grounds of rejections of one
or more of these claims based on other primary references are redundant and
we decline to reach them.

Method Claims 10-13
Grounds 1, 2, 8, 9, 11, 12, 13, 81 and 88 reject one or more of the
method claims 10-13 (RAN 5, 6 and 13). Of claims 10-13, only claim 10 is
an independent claim.
As a preliminary matter, the Patent Owner argues that claim 10 should
be interpreted to require two fasteners which are "two different types" as
described by their function (ABPO 69-70) and that the specification of the
'486 patent discloses a non-locking screw and a locking screw for their
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respective functions (ABPO 70). However, whereas the claims recite "first
fastener to hold the fracture reduction" and "second fastener" secured "at a
fixed angular relationship to the bone plate," we do not agree that such
recitations necessitates two different types of "screws" and in particular, a
"non-locking screw" and a "locking screw" as asserted by the Patent Owner.
Whereas the specification of the '486 patent discloses such locking and non-
locking screws, claim 10 is clearly broader than the disclosed embodiment.
Not only is the locking/non-locking screws not recited, claim 10 further
utilizes a term "fastener" that encompasses not only screws, but
encompasses a broader genus of devices of which screws are merely one
species.
Patent Owner argues that in specific embodiments described in the
patent a non-locking screw and locking screw serve as the first and second
fasteners (ABPO 70), but Patent Owner did not establish that one of ordinary
skill the art, upon reading the patent, would have recognized that such
fasteners would necessarily have had such non-locking and locking
structures. We note that a particular embodiment appearing in the written
description must not be read into the claim if the claim language is broader
than the embodiment. See Superguide Corp. v. DirecTV Enterprises, Inc.,
358 F.3d 870, 875 (Fed. Cir. 2004) ("Though understanding the claim
language may be aided by the explanations contained in the written
description, it is important not to import into a claim limitations that are not
a part of the claim. For example, a particular embodiment appearing in the
written description may not be read into a claim when the claim language is
broader than the embodiment.").
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Ground 2
Under Ground 2, claims 10-12 stand rejected as anticipated by
Kassab. The Patent Owner asserts that Kassab does not inherently disclose
the order of the method steps recited in the claim and in fact, a person of
ordinary skill in the art would understand that the screw for the threaded nut
was the first screw inserted in Kassab (ABPO 73, citing Decl. of Turen dated
March 22, 2010, ¶ 79). The Patent Owner also argues that Kassab also fails
to disclose "two different types of fasteners." (ABPO 73).
The Examiner finds that Kassab discloses the recited order because it
discloses "after tensioning, use of a schuhli at a distal screw." (RAN 17,
citing Kassab, p. 91, description for Fig. 3B). According to the Examiner,
"it is clear that the osteotomy is reduced and then 'tensioned' by the 'first'
fastener, i.e. the fastener shown bridging the osteotomy, and then a 'second'
fastener is inserted through the plate and a [s]chuhli on the proximal side of
the osteotomy." (RAN 17). We agree with the Examiner.
Kassab discloses that "after tensioning, use of a schuhli at distal screw
Number 4 on the proximal side of the osteotomy." (P. 91, Fig. 3A-D and
caption therewith). "[T]ensioning" refers to securing the plate against the
bone as shown in the illustration of Figure 3B and the radiograph of Figure
3D (id.). Further, contrary to the Patent Owner's assertion, Kassab explicitly
states that schuhli is used "after tensioning" thereby disclosing the sequence
of its use (id.). Whereas the schuhli nut may have to be positioned together
with the bone plate, Kassab states that it is not used (i.e., the screw inserted
there through) until after tensioning. The schuhli nut functions to secure the
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second fastener in a fixed angular relationship to the bone plate as recited by
claim 10.
The Patent Owner's argument that Kassab also fails to disclose "two
different types of fasteners" is unpersuasive because such language is not
present in the claim. In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (features
not appearing in the claims cannot be relied upon for patentability). To the
extent that the Patent Owner relies on the recited "first fastener" and a
"second fastener" to be interpreted to mean a "non-locking screw" and a
"locking screw," we disagree with such an interpretation for the reasons
discussed supra. The claim does not require "two different types of
fasteners" (much less a "non-locking screw" and a "locking screw") but
rather, merely recites a "first fastener" that is used for compression, and a
"second fastener at a fixed angular relationship to the bone plate." Kassab
discloses this limitation.
Secondary consideration evidence is not pertinent to anticipation
rejections, and thus, immaterial to the anticipation rejection of claims 10-12.
Thus, in view of the above, the Examiner's rejection of claims 10-12 as
being anticipated by Kassab is affirmed.

Ground 8
Method claims 10-13 also stand rejected as obvious over Schuhli
Guide in view of Klaue '823. The Patent Owner argues that the combination
of Schuhli Guide and Klaue '823 does not result in the claimed method
because it is the locking nut, instead of the plate, that is compressed against
the bone ("compressing a bone plate against the bone with at least one first
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fastener to hold the fracture reduction") (ABPO 75). The Patent Owner
further argues that only one type of screw is used in the cited prior art, but
the claim requires a first and second fastener (ABPO 75). The Examiner's
position is that it would have been obvious to make the nut in Schuhli Guide
integral to the plate, specifically relying on Figure 8B of Klaue '823 which
discloses providing a schuhli-type threaded protrusion integral to the lower
surface of a bone plate (RAN 20; Request for Inter Partes Reexamination,
Exhibit L).
We agree with the Examiner that the claimed invention would have
been obvious to one of ordinary skill in view of the combined teachings of
Schuhli Guide and Klaue '823. Klaue '823 clearly demonstrates the
obviousness of providing a plate with a threaded locking feature integrally
thereon (see Klaue '823, Fig. 9; col. 5, ll. 18-40). Furthermore, Schuhli
Guide discloses the recited order of inserting the first fastener through a hole
without a schuhli so as to stabilize the schuhlis (i.e., to compress the plate
and schuhli combination against the bone) before inserting the second
fastener through the schuhli (see Schuhli Guide, p. 7, steps 4 and 5; see also
Request for Inter Partes Reexamination, Exhibit L). As to evidence of
commercial success, the evidence does not demonstrate an adequate nexus
between the method of claims 10-13 and the sales of the LCP kits as
discussed infra under the heading "Commercial Success."
Hence, in view of the above, we affirm the Examiner's rejection of
claims 10-13 as being obvious over Schuhli Guide in view of Klaue '823.

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Ground 13
Claim 13 which depends from independent claim 10 stands rejected as
being obvious over Kassab. The Patent Owner relies on dependency of
claim 13 on claim 10 for patentability and refers to its arguments submitted
with respect to the anticipation rejection of claim 10 in Ground 2 (ABPO 79-
80). Again, the evidence of commercial success does not demonstrate an
adequate nexus as discussed infra. Thus, because claim 10 remains rejected
over Kassab in Ground 2 for the reasons discussed supra, the Examiner's
rejection of claim 13 is also affirmed.

Remaining Grounds
Each of the method claims 10-13 have been rejected under two
separate grounds. Hence, the other rejections of one or more of these claims
under Grounds 1, 8, 9, 11, 12
20
(for claim 11), 81 and 88 based on other
primary references are redundant and we decline to reach them.

Commercial Success
The Appellant alleges that it has sufficiently established non-
obviousness through evidence of commercial success and copying as set
forth in the Declaration of René Haag (App. Br. 80-84). The Examiner
states that the Declaration of Haag and the proffered evidence of commercial

20
As noted, this ground of rejection was maintained by the Examiner with
respect to claim 11, but withdrawn with respect to claim 12 (RAN 6, 22-24).
The withdrawal of this ground of rejection as to claim 12 has been cross-
appealed by the Requester.
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success and copying have been considered but finds them unpersuasive
(RAN 36). The Examiner incorporates by reference, the position of the
Requester as set forth in pages 87-99 of the Requester's comments filed
June 25, 2010 (id.). The Requester argues, inter alia, that the Patent Owner
has "failed to show that success of the Relevant Products was due [to] the
critical claimed features," that the products include unclaimed features, and
that the Patent Owner has not accounted for numerous unrelated economic
and market factors such as brand loyalty, purchasing contracts and market
share/power (Resp. Br. R 32-33).
As previously noted, we first observe that secondary consideration
evidence is not pertinent to anticipation rejections, and thus, is immaterial to
the anticipation rejection of claims 10-12 under Ground 2.
The evidence does appear to show commercial success of the kits in
which the bone plates referred to as Locking Compression Plate (shown in
Decl. of Haag, Exhibits A-C; hereinafter "LCP bone plates") are sold
together with corresponding locking and non-locking screws and various
other components (Decl. of Haag ¶¶ 19-25, Exhibits G-I). However, in
having considered the evidence, we agree with the Examiner that the
evidence does not adequately demonstrate non-obviousness of the claimed
invention.
As to all of the rejected claims, the various LCP bone plates upon
which the asserted commercial success is based include figure-eight shaped
"Combi holes" (Decl. of Haag, Exhibit A, 3; Exhibit B, 3; Exhibit C, 3)
which are not disclosed in the Specification of the '486 patent. The "Combi
holes" are clearly identified in the evidence as being a "feature" that
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"combine[s] a dynamic compression unit (DCU) hole with a locking screw
hole. The Combi hole provides the flexibility of axial compression and
locking capability throughout the length of the plate shaft." (Decl. of Haag,
Exhibit A, 2; Exhibit B, 2; Exhibit C, 2). As raised by the Requester and the
Examiner, the unique features and benefits of the "Combi holes" may have
contributed to commercial success, especially considering their asserted
advantageous function. Such features are not recited in any of the rejected
claims, nor disclosed in the specification of the '486 patent, and thus, can
diminish the nexus between the evidence of commercial success and the
claimed invention. However, while recognizing that this issue has been
raised in the appeal (Reb. Br. PO 32-33), the Patent Owner fails to proffer
rebuttal evidence, arguments or explanation to address the possible impact of
"Combi holes" in its Rebuttal Brief.
Furthermore, with respect to independent claim 1 which specifically
recites that the head portion has only first plate holes that have a thread, we
note that the commercial implementations of the LCP bone plates have holes
for "K-wire" and sutures that appear to be unthreaded (Decl. of Haag,
Exhibit A, 3; Exhibit B, 3; Exhibit C, 3).
We also agree with the Requester and the Examiner that the Patent
Owner has not adequately addressed other factors that may have had
significant bearing on the commercial success of the kits, and in particular,
group purchasing contracts. While the Patent Owner and Mr. Haag assert
that "Synthes did not implement any shift or change in its normal marketing
practices in the plate and screw market" (ABPO 83; Decl. of Haag, ¶ 26),
they fail to adequately explain the impact of "group purchasing
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organizations" used in the industry on the commercial success information
provided (see Decl. of Donoghue ¶ 15).
As to the method claims 10-13, we are not provided with persuasive
analysis as to how the evidence proffered supports the conclusion that the
recited method would not have been obvious. In this regard, the evidence
does not demonstrate an adequate nexus between the method recited in
claims 10-13 and the sales of the LCP kits.
Thus, because the evidence is insufficient to establish adequate nexus
between the claims and the commercial success, we agree with the Examiner
that the Patent Owner has failed to establish non-obviousness with respect to
the invention recited in the rejected claims. Finally, whereas copying by
competitors has been asserted by the Patent Owner (ABPO 84; Decl. of
Haag ¶ 25), we are not directed to persuasive evidence demonstrating
copying by others.

Conclusions for Patent Owner's Appeal
1. The Examiner did not err in concluding that it would have been
obvious to one of ordinary skill in the art to modify a condylar buttress plate
having a head portion that includes unthreaded bone anchor holes as
described in K982222 or Koval so as to only provide holes having a thread
in the head portion.
2. The Examiner did not err in concluding that providing a bone
plate with an anterior fork substantially parallel to an anterior side of the
shaft portion would have been an obvious variation, and that such a fork is
disclosed in the plate of the Synthes Catalog.
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3. The Examiner did not err in concluding that it would have been
obvious to one of ordinary skill in the art to modify a condylar buttress plate
as described in K982222 or Koval to provide threaded holes in the shaft
portion of the buttress plate as well as non-threaded holes.
4. The Examiner did not err in finding that the method of claim 10
is disclosed in Kassab.
5. The Examiner did not err in concluding that the method of
claim 10 would have been obvious to one of ordinary skill in the art based
on Schuhli Guide in view of Klaue '823.

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CROSS-APPEAL OF THE REQUESTER
The Non-adopted Rejections
The Requester cross-appeals the following proposed rejections that
were not adopted or not maintained by the Examiner:
Ground 12: Claim 12 under 35 U.S.C. § 103(a) as being obvious over
the combination of Locking Reconstruction Plate (hereinafter "LRP")
in view of Sutter and Surer.

Ground 86: Claim 12 under 35 U.S.C. § 103(a) as being obvious over
Distal Radius Plate (hereinafter "DRP") in view of Koval.

Ground 93: Claims 10-13 under 35 U.S.C. § 103(a) as being obvious
over Koval in view of DRP.

(CABR 2)
The primary reference LRP of Ground 12 pertains to a modular
fixation system for the jaw (see, generally, LRP). The primary reference
DRP of Ground 86 pertains to a plate for modular fixation system for the
forearm (see, generally, DRP). Claim 12 specifically recites application of
the method "wherein the fracture is adjacent at least one of the following
group: a distal tibia, a proximal tibia, a distal femur, or proximal femur."
However, both the LRP and DRP devices are for bones that do not bear the
weight of the body such as the tibia or the femur.
During the Oral Hearing, in response to a question asking whether
loading must be considered when the claim specifies the bone to which the
method is applied, the Requester conceded that the LRP and DRP references
do not address "some unique issues with respect to the femur and fixing
those fractures." (See Oral Hearing Transcript, pp. 46, l. 3-47, l. 16). As
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such, the Requester argued that the strongest rejection not adopted by the
Examiner is Ground 93 which is based on the combination of Koval and
DRP since Koval is directed to fixing fractures in the distal femur (id.).
Nonetheless, the Requester also concedes that Koval does not expressly
disclose the order of insertion of the first and second fasteners as recited by
claim 10, and that the teachings of DRP is required to address this deficiency
(see Oral Hearing Transcript, pg. 47, ll. 1-4).
In refusing to adopt the proposed rejection of claims 10-13 in Ground
93, the Examiner's position is that a person of ordinary skill, without the
benefit of hindsight based on the '486 patent, would not start with the
cadaver study disclosed in Koval, and then look to the teachings of the DRP
Guide "to apply the Koval plate on a femoral fracture by following the steps
of the DRP Guide." (RAN 29).
However, as discussed supra, claims 10-13 stand rejected under
Grounds 2 and Ground 13 (based on Kassab alone), and Ground 8 (based on
Schuhli Guide in view of Klaue '823). These rejections that have been
affirmed in the Patent Owner's appeal do not raise the above noted issues
that are present in proposed Grounds 12, 86 and 93. Correspondingly, in our
view, the cross-appealed rejections appear to be weaker than those already
addressed supra and are largely moot in view of the affirmed rejections of
these claims in the Patent Owner's appeal. As such, we decline to reach the
arguments of the Requester.

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ORDERS
1. The Examiner's rejections of one or more apparatus claims 1-9,
16 and 17 under Grounds 30-32, 47 and 89-92 are AFFRIMED.
2. We decline to reach the remaining grounds of rejection of the
apparatus claims.
3. The Examiner's rejections of one or more method claims 10-13
under Grounds 2, 8 and 13 are AFFIRMED.
4. We decline to reach the remaining grounds of rejection of the
method claims.
5. We decline to reach of the arguments of the Requester in the
Cross-Appeal.

Rejection of claims 1-13, 16 and 17 is:
AFFIRMED

Requests for extensions of time in this merged reexamination
proceeding are governed by 37 C.F.R. §§ 1.550(c) and 1.956.

ak

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Woodcock Washburn, LLP
Cira Centre, 12
th
Floor
2929 Arch Street
Philadelphia, PA 19104-2891

Third Party Requester:

Hunton & Williams, LLP
Intellectual Property Department
1900 K Street, NW
Suite 1200
Washington, DC 20006-1109