Ex Parte 7128744 et al

Board of Patent Appeals and Interferences

Jan 17, 2012

90009377 (B.P.A.I. Jan. 17, 2012)

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.
90/009,377 01/08/2009 7128744 SYNT-0702 4031
53443 7590 01/18/2012
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
01/18/2012 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.
95/000,465 05/05/2009 7128744 SYNT-0711 1725
53443 7590 01/18/2012
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
01/18/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

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

Appeal 2011-010701
Reexamination Control 95/000,465 and 90/009,3771
Patent US 7,128,744 B22
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, 14, 2009.
2 Issued October 31, 2006 to Weaver et al. (hereinafter "'744 patent").
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The Patent Owner (hereinafter "Appellant") appeals under 35 U.S.C.
§§ 134, 306 and 315 (2002) from a Final Rejection of claims 1-55. We have
jurisdiction under 35 U.S.C. §§ 134, 306 and 315 (2002).
In addition to the Appeal Brief (hereinafter "App. Br."), the Appellant
also relies on Declarations of Drs. Turen and Parsons and Mr. Haag, and
Exhibits therein, in support of patentability including secondary
consideration evidence. The Appellant further relies on a Rebuttal Brief
(hereinafter "Reb. Br.") filed in response to the Examiner's Answer, the
latter which merely incorporates the Right to Appeal Notice (hereinafter
"RAN").
The Requester (hereinafter "Respondent") has filed a Respondent
Brief (hereinafter "Resp. Br."), and relies on the Declarations of Mr.
Donoghue and Dr. Marsh in support of the Examiner's rejections. The
Respondent does not cross-appeal the Examiner's refusal to adopt various
proposed rejections (RAN 21), or the Examiner's withdrawal of other
previously adopted rejections (RAN 24).
An oral hearing with the Appellant's representative and the
Respondent's representative was held before the Board of Patent Appeals
and Interferences on December 7, 2011, a transcript of which will be made
of record in due course.
The '744 patent is presently involved in the following infringement
litigation proceedings, both of which have been stayed pending the
conclusion of the present reexamination proceeding (App. Br. 1):
1. Synthes (U.S.A.) v. Smith & Nephew, Inc., Civil Action No. 03-
0084 (E.D. Pa); and
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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.).
The citations in this decision are to the record of inter partes
Reexamination Control 95/000,465, including the Request for Inter partes
Reexamination (hereinafter "Request"), unless otherwise indicated.
We AFFIRM-IN-PART.

THE INVENTION
Claims 1-55 on appeal are directed to a bone plating system which is
used to repair a bone fracture. Claims 1, 24 and 53 are independent claims,
claim 53 being similar to claim 24. Representative independent claims 1 and
24 read as follows (App. Br., Claims App'x., emphasis added):
1. (Original) A bone plating system for improving the
stability of a bone fracture in a long bone comprising:
a bone plate having:
an upper surface;
a lower surface;
a shaft portion having a width and a central
longitudinal axis, the shaft portion configured and
dimensioned to extend along at least a portion of a
diaphysis of the bone and the lower surface of the
shaft portion having a plurality of arched cut-outs
extending transverse to the longitudinal axis; and
a head portion that flares outward from the
shaft portion so as to have a width that is greater
than the width of the shaft portion, the head
portion curving upward from the shaft portion and
having at least three bone anchor holes, the bone
anchor holes being conically tapered from the
upper surface to the lower surface, the at least
three bone anchor holes having at least a portion
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that has a thread to engage a thread on a head of a
bone anchor,
wherein the head portion has only bone anchor
holes having the threaded portion, the shaft portion,
having a plurality of holes having at least a portion that
has a thread to contact the thread on the head of a bone
anchor.

24. (Original) A bone plating system for improving the
stability of a bone fracture in a long bone comprising:
a bone plate having:
an upper surface;
a lower surface;
a shaft portion having a width and a central
longitudinal axis, the shaft portion configured and
dimensioned to extend along at least a length of a
diaphysis of the bone and the lower surface of the
shaft portion having a plurality of arched cut-outs
extending transverse to the longitudinal axis; and
a head portion having a width that is greater
than the width of the shaft portion and which
curves upward from the shaft portion, the head
portion having a plurality of conically tapered
holes having at least a portion that has a thread to
contact a bone anchor,
wherein the shaft portion has a plurality of
conically tapered holes having at least a portion that has
a thread to contact a thread on the head of a bone
anchor, and the shaft portion of the bone plate has a
thinner cross section in regions between the plate holes.

In addition, dependent claim 32 reads as follows (App. Br., Claims
App'x.):
32. (Original) The bone plating system of claim 24,
wherein all of the holes located in the head portion for
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receiving bone anchors have at least a portion that is
threaded.

THE REJECTIONS
In the present appeal, there are 52 different grounds of rejection
identified as Grounds 1-8, 12-31, 35-55 and 86-88 (RAN 29). The remaining
Grounds 9-11, 32-34 and 56-85 proposed by the Respondent were not
adopted by the Examiner (RAN 29). In the 52 different grounds of rejection,
various claims are rejected under 35 U.S.C. §103(a) as obvious over various
combinations of 15 prior art documents of record. In view of the high
number of rejections, we do not reproduce the rejections herein. However,
the 52 obviousness rejections can be categorized as follows:
1. Rejections of all claims principally based on K982222
(Grounds 1-8, 12-23) (RAN 4-7, 27);
2. Rejections of all claims principally based on Koval (Grounds
24-31, 35-55) (RAN 7-12, 28); and
3. Rejections of all claims principally based on Synthes Catalog
(Grounds 86-88) (RAN 16-17)3.

In addition, not all of the prior art references relied upon by the
Examiner in rejecting the various claims are pertinent to the disposition of
the present appeal. Instead, the dispositive issues center on the following
five references:

3 These grounds of rejection were proposed in the ex parte Reexamination
Control 90/009,377.
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1. Collin, Surgical Instruments (1935) (catalog) (hereinafter
"Collin");

2. Koval et al., Distal Femoral Fixation, Journal of Orthopaedic
Trauma (Oct. 1997) (hereinafter "Koval");

3. Haas et al., LISS-Less Invasive Stabilization System, OP-
JOURNAL, Issue 3, Volume 13, pp. 340-344 (Dec. 1997) (citations to
translation) (hereinafter "Haas");

4. Synthes, 1997 Edition (1997) (catalog) (hereinafter "Synthes
Catalog"); and

5. Synthes, Synthes Condylar Buttress Plates (July 1998)
(hereinafter "K98222").

ISSUES
While there are 52 different grounds of rejection on appeal, the
dispositive issues are few and 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, Koval or Synthes Catalog so as to only provide holes
having a threaded portion in the head portion of the buttress plate.
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.
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3. Whether the Examiner properly construed the claim limitation
"a plurality of conically tapered holes having at least a portion that has a
thread" recited in independent claims 24 and 53 to encompass a hole
disclosed in Collin that includes a conically tapered portion and a partially
threaded cylindrical hole portion.
4. Whether the Appellant has sufficiently established non-
obviousness through evidence of commercial success.

PRINCIPLES OF LAW
"The combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results."
KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-16 (2007). "[W]hen a
patent claims a structure already known in the prior art that is altered by the
mere substitution of one element for another known in the field, the
combination must do more than yield a predictable result." Id. at 416. "If a
person of ordinary skill can implement a predictable variation, §103 likely
bars its patentability." Id. at 417. The Court also affirmed that "when a
patent claims a structure already known in the prior art that is altered by the
mere substitution of one element for another known in the field, the
combination must do more than yield a predictable result." Id. at 416. In
addition, "the analysis need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can take account
of the inferences and creative steps that a person of ordinary skill in the art
would employ." KSR, 550 U.S. at 418. In this regard, "[a] person of
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ordinary skill is also a person of ordinary creativity, not an automaton." Id.
at 421.
However, a "patent composed of several elements is not proved
obvious merely by demonstrating that each of its elements was,
independently, known in the prior art[,]" and "it can be important to identify
a reason that would have prompted a person of ordinary skill in the relevant
field to combine the elements in the way the claimed new invention does."
Id. at 418. The Court also noted that "[t]o facilitate review, this analysis
should be made explicit." KSR, 550 U.S. at 418, (citing In re Kahn, 441
F.3d 977, 988 (Fed. Cir. 2006) ("[R]ejections on obviousness grounds
cannot be sustained by mere conclusory statements; instead, there must be
some articulated reasoning with some rational underpinning to support the
legal conclusion of obviousness")). Further, if proposed modification would
render the prior art invention being modified "inoperable for its intended
purpose", then there is no suggestion or motivation to make the proposed
modification. In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984); In re Ratti,
270 F.2d 810, 813 (CCPA 1959).
Any initial obviousness determination is reconsidered anew in view of
the proffered evidence of nonobviousness. See In re Rinehart, 531 F.2d
1048, 1052 (CCPA 1976); In re Eli Lilly & Co., 902 F.2d 943, 945, (Fed.
Cir. 1990). The scope of the "objective evidence of non-obviousness must
be commensurate in scope with the claims which the evidence is offered to
support." In re Tiffin, 448 F.2d 791, 792 (CCPA 1971). The objective
evidence is not commensurate in scope with the claimed subject matter if the
claims are unreasonably broader in scope than the scope of the objective
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evidence or if the product included elements or features not recited in the
claims which may be responsible for the commercial success or praise. See
Joy Tech., Inc. v. Manbeck, 751 F. Supp. 225, 229-30 (D.D.C. 1990) (and
cases cited therein), aff'd, 959 F.2d 226 (Fed. Cir. 1992).
A "nexus" must also be established between the merits of the claimed
invention and the evidence of secondary considerations in order for the
evidence to be given substantial weight. See In re GPAC, Inc., 57 F.3d 1573,
1580 (Fed. Cir. 1995). If evidence of commercial success is relied upon, the
Appellant must offer proof "that the sales were a direct result of the unique
characteristics of the claimed invention-as opposed to other economic and
commercial factors unrelated to the quality of the patented subject matter."
In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996); see also Asyst Techs., Inc.
v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008) ("While the evidence
shows that the overall system drew praise as a solution to a felt need, there
was no evidence that the success of the commercial embodiment . . . was
attributable to the . . . only material difference between [the prior art] and
the patented invention.") (citation omitted, emphasis added); In re Kao, 639
F.3d 1057, 1068 (Fed. Cir. 2011) ("Where the offered secondary
consideration actually results from something other than what is both
claimed and novel in the claim, there is no nexus to the merits of the claimed
invention").

ANALYSIS
Much of the relevant facts as to what the pertinent prior art discloses
are not in dispute. K982222 and Koval each disclose a condylar buttress
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plate that includes a head portion with holes having a threaded portion, but
also includes two holes that are not threaded (K98222 Description; Koval
Abstract, Discussion, Fig. 1; see also App. Br. 17-20; Resp. Br. 4-5).
Synthes Catalog discloses a condylar buttress plate for Distal Femur
Operations with only non-threaded holes (Synthes Catalog pg. 2a-24; see
also App. Br. 11; Resp. Br. 4-5). Haas discloses a "Less Invasive
Stabilization System" (hereinafter "LISS") bone plate in which all of the
holes are conical and threaded to receive screws with threaded heads (Haas,
pgs. 340-341, Diags. 3 and 4; see also App. Br. 20-22; Resp. Br. 6). Any
factual dispute as to the scope of disclosure in the prior art is addressed in
the context of addressing the above noted issues.

Issue 1
The Examiner's rejections of claim 1 are based on the conclusion that
it would have been obvious to one of ordinary skill in the art to modify a
condylar buttress plate having a head portion with unthreaded bone anchor
holes as described in K982222, Koval or Synthes Catalog so as to only
include conically tapered holes having a threaded portion (see, e.g., RAN
17). The Examiner adopted the rejections as proposed and articulated by the
Respondent in its requests for ex parte reexamination and inter partes
reexamination with its numerous claim charts (RAN 17). For example, with
respect to the rejection of claim 1 based on K982222, the Request stated:
To the extent that K982222 does not disclose a head portion
having at least three threaded bone anchor holes which are
conically tapered, it 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
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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. "[S]crew/plate connection which is achieved by
means of the outer thread of the screw head and an internal
threading of the plate hole." (Figs. 3 and 4; p. 341). The plate
holes of Haas are all threaded and conically tapered, therefore,
the head has only threaded, conically tapered holes. 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
the plate hole, thus prohibiting a varying direction the [sic]
screw" (p. 341)).
(Request, Exhibit E, 4; see also Request 41-42).
The above reproduced rationale is representative of the adopted
rejections of claim 1 based on Koval and Synthes Catalog as well (see, e.g.,
Request 53-54, Exhibit M, 7-8; Ex parte Reexamination Request 13-14).
With respect to claim 1, the Appellant argues that there is no
motivation for one of ordinary skill in the art to combine the disclosure in
Haas with any of the condylar buttress plates described in K982222, Koval
or Synthes Catalog because the resultant modified plate "would not have
worked for its intended purpose." (App. Br. 6; see also Rebuttal Br. 3, 7).
The Appellant points out that condylar buttress plates include at least two
unthreaded holes in the head portion for use as "a reduction aid in reducing
and setting" the bone fracture with standard bone screws so as to "allow
surgeons to compress the head portion to the underlying condylar bone
surface and thereby properly secure the head portion to the condylar
surface." (App. Br. 6; see also Rebuttal Br. 5). The Appellant argues that if
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all of the holes in the head of the condylar buttress plates are threaded and
locking screws with threaded heads are used, the "capacity of the plate to
function as a reduction aid" is eliminated and compression of the head
portion against the condylar portion of the bone cannot be attained (App. Br.
6-7; see also Rebuttal Br. 10).
The Examiner responds that the Specification of the '744 patent
"expressly admits that non-locking screws (i.e. screws with unthreaded
heads) can be used in threaded holes." (RAN 22, citing col. 6, ll. 49-51).
However, as noted by the Appellant (App. Br. 43), the portion of the '744
patent cited by the Examiner pertains to the disclosed invention, and is not
an admission. Thus, the Examiner's reliance upon it in rejecting claim 1 is
misplaced.
We agree with the Appellant and in our view, the modification to
conventional condylar buttress plates suggested by the Examiner appears to
be based on impermissible hindsight. The preponderance of the evidence of
record indicates that an important function of conventional condylar buttress
plates is to allow generation of compression between the plate and the bone,
such compression being attained by conventional bone screws with non-
threaded heads which are received through non-threaded holes (see, e.g.,
Decl. of Mssrs. Parsons, ¶¶ 12-18; Turen, ¶¶ 12-15; and Marsh ¶¶ 11-12).
This compression function of the condylar buttress plates disclosed in
K982222, Koval or Synthes Catalog undermines the articulated reason for
providing only at least partially threaded, conically tapered holes in the head
portion thereof. KSR, 550 U.S. at 418; In re Gordon, 733 F.2d at 902; In re
Ratti, 270 F.2d at 813. Further, as discussed infra, the evidence of record is
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insufficient to establish that the tapered holes disclosed in Haas are usable to
impart compression between the head portion of the buttress plates.
To be clear, we do not disagree with the Examiner or the Requester
that the provision of threaded holes in the head portion of a bone plating
system would have been desirable (see, e.g., Decl. of Marsh, ¶ 55). Indeed,
the record indicates that such desirability was recognized by Bolhofner,4 as
well as K98222 and Koval. However, the question with respect to claim 1 is
whether it would have been obvious to then eliminate non-threaded holes in
their entirety from the head portion of condylar plates to only provide at least
partially threaded, conically tapered holes thereon. The evidence of
development in the art in view of Bolhofner indicates that it was obvious to
those of ordinary skill in the art to only thread some of the screw holes (see
K98222 and Koval) supporting the Patent Owner's argument of non-
obviousness.
The Requester also asserts that compression may be attained using
other methods and devices so that the use of non-threaded holes is not
necessary and that such modified plates may still be used to treat different
types of fractures (Resp. Br. 14-18; Decl. of Marsh, ¶¶ 55). The Requester
further argues that the prior art does not teach away from the suggested

4 Bolhofner et al., The Results of Open Reduction and Internal Fixation of
Distal Femur Fractures Using a Biologic (Indirect) Reduction Technique,
Journal of Orthopaedic Trauma, Vol. 10, No. 6, pp. 372-377, 376 (1996)
(hereinafter "Bolhofner").

Bolhofner is not relied upon by the Examiner in any ground of rejection.
However, both the Appellant and the Requester reference Bolhofner as
evidence of the art immediately prior to Koval and K982222.

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modification and that there would be a reasonable expectation of success for
combing the prior art as suggested (Resp. Br. 12-13). However, the
Requester's arguments do not satisfactorily address why one of ordinary skill
in the art would modify condylar buttress plates that already have provisions
for attaining compression via the non-threaded holes so as to remove this
significant functionality (see, e.g., Decl. of Turen, ¶¶ 42-45), and to further
require different devices and techniques to be used for attaining the
compression. In this regard, whereas providing threaded holes in the head
portion would expand the application and utility of the bone plates when
non-threaded holes are maintained (see, e.g., Bolhofner, pg. 376), removing
the non-threaded holes altogether would not allow the modified condylar
buttress plates to be used in the manner and for the purpose intended in
K98222 and Koval. In this regard, the evidence of record is insufficient to
establish that the tapered holes recited in claim 1 are usable to impart
compression between the head portion of the buttress plates and the bone as
discussed in further detail infra. In our view, the position of the Examiner
and the Respondent does not appear to be based on adequate rational
underpinnings. KSR, 550 U.S. at 418.
In further arguing obviousness, the Respondent pointed out during the
Oral Hearing that the Examiner cited to the wrong portion of the '744 patent
and directed our attention (Hearing Transcript; See also Requester's
Comments Sept. 17, 2010) to the discussion of the prior art therein which
states:
U.S. Patent No. 5,709,686 discloses a bone plate with partially
threaded plate holes. The partially threaded holes allow either
non-locking or locking screws to be used. Because the plate
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holes are only partially threaded, the locking screws used may
not be able to maintain the fixed angular relationship between
the screws and the plate under physiological loads.
(Col. 2, ll. 17-21).

While this portion of the Specification of the '744 patent
acknowledges a bone plate with partially threaded plate holes for use with
non-locking or locking screws in U.S. Patent No. 5,709,686 (hereinafter
"'686 patent"), we observe that claim 1 is structurally distinguished from the
partially threaded plate holes of the '686 patent in that claim 1 specifically
requires the bone anchor holes on the head portion to be "conically tapered
from the upper surface to the lower surface." The partially threaded holes of
the '686 patent that include an unthreaded conically flaring area 5 and a
separate threaded straight portion 3 as disclosed therein ('686 patent, col. 2,
ll. 27-29, 51-64; Figs. 1, 6-7) cannot be reasonably said to satisfy this
limitation. A hole that is "conically tapered from the upper surface to the
lower surface" as recited in claim 1 is only shown in the record by the
threaded hole of Haas. Thus, the question remains as to whether it would
have been obvious to one of ordinary skill in the art to utilize the threaded
holes as disclosed in Haas when such holes are not disclosed as being used
with corresponding non-locking screws that would allow for compression
between the bone plate and the bone.
The Respondent asserts that use of threaded, conically tapered holes is
merely one of numerous configurations and that compression can still be
attained with known threaded holes (Resp. Br. 19). However, we are not
provided with persuasive, objective evidence establishing that partially
threaded plate holes that are "conically tapered from the upper surface to the
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lower surface" were one of the known hole configurations that were suitable
for use with both non-locking and locking screws. The Respondent's
arguments based on the fact that the use of a partially threaded plate holes
for use with non-locking or locking screws was also known in both the
Locking Reconstruction Plate (hereinafter "LRP") and Distal Radius Plate
(hereinafter "DRP") technologies (Resp. Br. 7, 9, 19) are not persuasive.
Firstly, the Examiner's adopted rejections are not predicated on either LRP
or DRP technologies. In addition, both of these technologies utilize holes
that are not "conically tapered from the upper surface to the lower surface"
as specifically recited by claim 1 (see also, RAN 24 with respect to LRP).
Thus, like the disclosure of the '686 patent, LRP and DRP technologies are
structurally deficient and do not meet the claim limitation.
Whereas the Requester further argues that a standard bone screw can
simply be used (Resp. Br. 20), there lacks persuasive, objective evidence of
such use of standard bone screws in a conical tapered hole having a threaded
portion such as that disclosed in Haas. The Requester's assertion that Haas
discloses a countersunk upper portion which allows for the use of standard
bone screws (Resp. Br. 20) ignores the fact that the chamfering provided on
the holes of Haas is very small and shallow. Hence, Haas's disclosure calls
into question the Requester's assertion. In this regard, we also find
persuasive the Appellant's argument based on expert testimony that a person
of ordinary skill would not use conventional bone screws in the conical
tapered holes of Haas due to the lack of a countersunk upper portion in the
tapered holes, which would result in the head sitting high atop the plate
(App. Br. 39, 42; Decl. of Turen ¶¶ 63).
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In view of the above, we conclude that the rejection of claim 1
appears to be based on hindsight. Neither the Examiner nor the Respondent
has sufficiently shown that it would have been obvious to one of ordinary
skill in the art to eliminate non-threaded holes from the head portion of
condylar plates and only provide at least partially threaded, conically tapered
holes thereon. Hence, the Examiner's rejections of independent claim 1 are
not sustained. Claims 2-23 ultimately depend from independent claim 1, and
thus, the rejections of these claims are also reversed. The Appellant's
arguments directed to patentability of claim 1 based on the limitation "the
shaft portion having a plurality of holes having at least a portion that has a
thread" are moot with respect to claim 1, but unpersuasive for the reasons
discussed infra relative to independent claims 24 and 53.

Issue 2
Independent claims 24 and 53 differ from claim 1 in that, inter alia,
they merely recite a "head portion having a plurality of conically tapered
holes having at least a portion that has a thread to contact a bone anchor."
Thus, these claims do not require all of the holes in the head portion to be
conically tapered holes with a threaded portion. The Appellant relies on the
limitation requiring the shaft of the bone plate to include a plurality of
threaded holes for patentability and argues that "there was no motivation in
the art to replace a plurality of the DCU [non-threaded] holes in the shaft
portion of the condylar buttress plates of these three primary references
[K982222, Koval, Synthes Catalog] with the LISS-style locking holes of
Haas." (App. Br. 7, 46).
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The Examiner adopted the rejections as proposed by the Respondent
(RAN 17). For example, with respect to the rejection of claim 24 based on
K982222, the Request stated:
To the extent that K982222 does not disclose a shaft portion
having at least partially threaded holes, it would be obvious to
one of ordinary skill in the art to modify K982222 to include
threaded holes in the shaft since these type of holes are 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. Haas, for example,
discloses a shaft portion with threaded holes. As discussed
above, all the plate holes of Haas are threaded. It would be
obvious to one of ordinary skill in the art to combine the
disclosure from K982222 and the Haas Article to arrive at a
plate having threaded holes in the shaft. The advantages of the
threaded holes disclosed in the Hass Article, would have been
well known to a person of ordinary skill in the art.

Accordingly, there existed ample motivation for a person of
ordinary skill in the art to improve K982222 to include threaded
holes in the shaft. Thus it would have been obvious to combine
the unthreaded second holes disclosed in K982222, with the
threaded first holes disclosed in the Hass Article to arrive at the
claimed shaft portion having threaded plate holes.
(Request, Exhibit E, 32; see also Request 41-42).

The Appellant refers to the arguments submitted with respect to
independent claim 1 and the Appellant argues that the primary references are
"designed with only unthreaded, dynamic compression unit (DCU) holes in
the shaft portion. Haas does not override the explicit teachings in the
primary references in this regard to use only unthreaded DCU holes, and
does not suggest that the function provided by the DCU holes should be
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removed or altered in any way." (App. Br. 43; see, e.g., Decl. of Parsons, ¶¶
68, 71). We disagree with the Appellant.
Firstly, the primary references do not explicitly teach the use of only
unthreaded DCU holes so as to expressly teach away from use of threaded
holes. Mere description of an implementation in the prior art that differs
from the Appellants' claimed invention, without more, does not show that
the prior art is "teaching away" from the invention claimed. In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004) ("the prior art's mere disclosure of
more than one alternative does not constitute a teaching away from any of
these alternatives because such disclosure does not criticize, discredit, or
otherwise discourage the solution claimed"). The mere fact that the devices
of the prior art such as K982222 "features dynamic compression unit (DCU)
screw holes," (App. Br. 45) does not mean that the reference is teaching that
no other embodiments would be useful. While there is no explicit teaching
to provide both threaded and unthreaded holes in the shaft of the bone plate,
such an explicit teaching is not required to show obviousness. KSR, 550 U.S.
at 418.
As discussed above, the prior art of record sufficiently establishes the
desirability of providing threaded holes in the head portion of a bone plating
system together with unthreaded holes for compression purposes (see
K98222, Koval). Whereas the Appellant argues that a person of ordinary
skill would not look to the LISS technology which stabilizes a bone fracture
differently and without contact between the plate and the bone (App. Br. 44-
45), the use of threaded holes with locking screws is established in the art as
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being desirable to achieve an angular stabile connection, whether it is for
condylar buttress plates (K98222, Koval) or for LISS type of plates (Haas).
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. Accordingly, our concerns discussed supra relative to the rejection of
claim 1 are not raised with respect to claims 24 and 53. The Appellant's
argument with respect to the impropriety of using conventional bone screws
in the conically tapered holes of Haas would not be applicable since the
screws as disclosed Haas can be used in the correspondingly shaped
conically tapered 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 condylar buttress plates, the angular stabile
connection of the screw/plate connection as taught in Haas can be attained.
Similar reasoning applies to provision of a plurality of conically
tapered holes with a thread portion in the head portion of the bone plate as
required by these claims. With respect to the Synthes Catalog, it would have
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been obvious to provide threaded holes for use with locking screws,
especially in view of K982222 and Koval that already include threaded holes
on the head portion. It would have also been obvious to one of ordinary skill
in the art that the types of holes disclosed in Haas are entirely suitable for
attaining the angular stabile connection. While the threaded holes in the
head portion of K982222 and Koval may differ from the claims in that they
are not conically tapered, we agree with the Examiner that the threaded holes
of K992222, Koval and Haas, are all different type of threaded holes for
receiving corresponding locking screws, use of any of these threaded holes
would have been obvious to one of ordinary skill. In this regard, the use of
the threaded holes disclosed in Haas in the head portion of K982222 or
Koval is "the mere substitution of one element for another known in the
field" which merely yields a predictable result. KSR, 550 U.S. at 416.
Thus, for the reasons discussed, the invention of claims 24 and 53 is
merely combination of elements found in the prior art which yields
predictable results which would have been obvious to a person of ordinary
skill who is also a person of ordinary creativity. KSR, 550 U.S. at 415-16,
421.
Claim 32 which depends from claim 24 specifically recites that "all of
the holes located in the head portion" have a threaded portion. The
Appellant relies on the same arguments made with respect to claim 1 to
contend patentability (App. Br. 8, 47-48). We reverse the Examiner's
rejection of claim 32 for the reasons discussed supra with respect to claim 1.

Issue 3
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The Appellant also argues that the Examiner's rejection of
independent claims 24 and 53 based on K982222, Koval or Synthes Catalog
in view of Collin (Grounds 12-15, 35-38; RAN 6, 9, 27) is improper because
the Examiner misconstrued the limitation "a plurality of conically tapered
holes having at least a portion that has a thread" to encompass holes
disclosed in Collin (App. Br. 46). The Appellant argues that the claim
limitation "means that in the head portion there are a plurality of holes that
have a section that is conically tapered and at least a portion of that
conically-tapered section is threaded." (App. Br. 46-47, emphasis added).
The Examiner asserts that under the broadest reasonable interpretation, these
claims "do not require the plurality of holes in the head portion of the plate
be conically tapered along the entire depth of the holes." (RAN 27,
emphasis in original).
We do not agree with either the Appellant's construction or the
Examiner's construction. The plain language of these claims requires the
holes to be "conically tapered," not that the holes have a section that is
conically tapered as asserted by the Appellant. In other words, the claim
language with respect to the conically tapering is with respect to the hole,
not a portion or section of the hole. In this regard, these claims further recite
"at least a portion" of the conically tapered holes having a thread, thereby
indicating that the recited tapering refers to the entirety of the hole and not
just a section thereof as asserted. Thus, these claims, when properly
interpreted, require the plurality of holes in the head portion of the plate be
conically tapered along the entire depth of the holes and to have a portion of
the conically tapered hole to be threaded.
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Our construction is consistent with the Specification of the '744
patent, which in the context of threaded holes including a conical taper with
threads thereon, are conically tapered along the entire depth of the holes
(see, e.g., Fig. 12-18). In contrast, the Appellant does not direct us to where
the Specification of the '744 patent discloses a hole that merely includes a
conically tapered section having a portion that is threaded. Our construction
is also is contrary to the Examiner's construction which is satisfied by a hole
that merely includes a conically tapered portion such as that shown in
Collin. We view such construction to be unreasonably broad in view of the
claim language. Thus, as the Examiner's rejection was premised on an
improper interpretation of the claims, we do not sustain the Examiner's
rejections based on K98222, Koval or Synthes Catalog in view of Collin
(Grounds 12-15, 35-38).

Commercial Success
The Appellant alleges that it has sufficiently established non-
obviousness through evidence of commercial success which is set forth in
the Declaration of René Haag (App. Br. 48-52). The Examiner argues that
sufficient nexus has not been shown between the merits of the invention and
the evidence of commercial success (RAN 30, incorporating by reference,
Respondent's Comments filed September 17, 2010, pages 17-21). The
Respondent further asserts that "Appellant's commercial success arguments
are also deficient because the Relevant Patents include features that are not
disclosed or claimed in the '744 Patent." (Resp. Br. 23).
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We initially observe that the rejections of claims 1-23 and 32 that
specifically recite that the head portion has only holes having a threaded
portion have been reversed supra. Thus, we evaluate the evidence of
commercial success in the context of independent claims 24 and 55 that are
broader than claims 1-23 in that they merely require the head portion and the
shaft portion to have "a plurality of conically tapered holes having at least a
portion that has a thread."
We reconsider the initial obviousness determination anew in view of
the proffered evidence of nonobviousness. See In re Rinehart, 531 F.2d at
1052; In re Eli Lilly & Co., 902 F.2d at 945. In having so considered the
evidence, we find that the Appellant has not sufficiently shown non-
obviousness of claims 24 and 53 based on the evidence of commercial
success. The evidence does show commercial success of the kits in which
the bone plates referred to as Locking Compression Plate (hereinafter "LCP
bone plates") are sold together with corresponding locking and non-locking
screws, the LCP bone plates being a major component thereof (Decl. of ¶¶ 9,
10, 18, 19). However, the scope of the "objective evidence of non-
obviousness must be commensurate in scope with the claims which the
evidence is offered to support." In re Tiffin, 448 at 792; see also Asyst
Tech., Inc., 544 F.3d at 1316. While the LCP bone plates relied upon by the
Appellant may be encompassed by independent claims 24 and 53, the
submitted evidence of commercial success is not commensurate with the
scope of these claims for the reasons discussed infra.
Firstly, we observe that the LCP bone plates relied upon by the
Appellant to establish commercial success all have only threaded holes in
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the head portion for receiving screws (Decl. of Haag, ¶¶ 13-16 and Exhibits
A-C). However, independent claims 24 and 53 do not require all of the holes
in the head portion to be conically tapered holes with a threaded portion.
The evidence of commercial success does not have to be commensurate with
each and every possible embodiment of an invention, however the disparity
between the scope of these broader claims and the proffered evidence cannot
be overlooked because this feature of providing only threaded holes on the
head portion of the LCP bone plates, in conjunction with corresponding
threaded and non-threaded screws of the kit, may have contributed to the
commercial success.
In addition, K982222 and Koval establish that providing both
threaded and non-threaded holes in the head portion of a bone plate was
known in the prior art and appreciated therein to be desirable. The only
material difference between the prior art K982222 or Koval and the
invention of independent claims 24 and 53 is the provision of both threaded
and non-threaded holes on the shaft portion of the claimed invention. The
evidence of record is not persuasive in establishing that the commercial
success is attributable to this material difference. See Asyst Techs., Inc., 544
F.3d at 1316; In re Kao, 639 F.3d at 1068. In particular, all of the LCP bone
plates upon which commercial success is based include unconventional,
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 '744
patent. The "Combi holes" are clearly identified in extrinsic evidence as
being a "feature" that "combine a dynamic compression unit (DCU) hole
with a locking screw hole. The Combi hole provides the flexibility of axial
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compression and locking capability throughout the length of the plate shaft."
(Decl. of Haag, Exhibit A, 2; Exhibit B, 2; Exhibit C, 2). The unique
features of the "Combi holes" may have contributed to commercial success,
especially considering their asserted advantageous function. Such features
are not recited in claims 24 and 53, and thus would not establish a nexus
between the commercial success and the merits of the claimed invention.
The Appellant does not provide persuasive evidence to establish that the
above noted features of the LCP bone plates relied upon as evidence did not
form the basis of the commercial success in evidence.
Thus, because the evidence is not commensurate with the scope of the
claims, and sufficient nexus has not been established between the evidence
and the claimed invention, we find no error in the Examiner's conclusion
that the Appellant failed to establish non-obviousness with respect to the
invention recited in claims 24 and 53.

CONCLUSIONS
1. 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.
2. 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, Koval or Synthes Catalog to provide holes in the
shaft portion having a threaded portion as well as non-threaded holes.
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3. The Examiner erred in construing the claim limitation "a
plurality of conically tapered holes having at least a portion that has a
thread" recited in independent claims 24 and 53 to encompass a hole
disclosed in Collin that includes a conically tapered portion and a partially
threaded cylindrical hole portion.
4. The Appellant has not sufficiently established non-obviousness
through evidence of commercial success.

ORDERS
1. Rejections principally based on K982222 (Grounds 1-8, 12-23) are
decided as follows:
A. Grounds 1-8 and 16-23 are REVERSED with respect to claims
1-23 and 32, but are AFFIRMED with respect to claims 24-31 and 33-
55.
B. Grounds 12-15 that also rely on Collin to reject claims 24-55
are REVERSED.

2. Rejections principally based on Koval (Grounds 24-31, 35-55) are
decided as follows:
A. Grounds 24-31 and 36-55 are REVERSED with respect to
claims 1-23 and 32, but are AFFIRMED with respect to claims 24-31
and 33-55.
B. Grounds 35-38 that also rely on Collin to reject claims 24-55
are REVERSED.

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3. Rejections principally based on Synthes Catalog, Grounds 86-88,
are REVERSED with respect to claims 1-23 and 32, but are AFFIRMED
with respect to claims 24-31 and 33-55.

AFFIRMED-IN-PART

Requests for extensions of time in this merged reexamination
proceeding are governed by 37 C.F.R. §§ 1.550(c) and 1.956. See 37 C.F.R.
§§ 41.50(f) and 41.77(g).

ack

cc:

Patent Owner
WOODCOCK WASHBURN LLP
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2929 ARCH STREET
PHILADELPHIA, PA 19104

Third Party Requester
ROBERT A, KING
HUNTON & WILLIAMS, LLP
INTELLECTUAL PROPERTY DEPARTMENT
2200 Pennsylvania Avenue, N.W.
WASHINGTON, DC 20037