Ex Parte 6511509 et al

Board of Patent Appeals and Interferences

Oct 27, 2011

90009348 (B.P.A.I. Oct. 27, 2011)

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.
90/009,348 12/03/2008 6511509 101896-1116 7762
21125 7590 10/27/2011
NUTTER MCCLENNEN & FISH LLP
SEAPORT WEST
155 SEAPORT BOULEVARD
BOSTON, MA 02210-2604
EXAMINER
REIP, DAVID OWEN
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
10/27/2011 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
____________________

Ex parte DEPUY MOTECH ACROMED, INC. and LIFENET HEALTH1
Appellants, Patent Owners
____________________

Appeal 2011-010510
Reexamination Control 90/009,348
Patent US 6,511,509 B12
Technology Center 3900
____________________

Before JAMESON LEE, DANIEL S. SONG and JOSIAH C. COCKS,
Administrative Patent Judges.

SONG, Administrative Patent Judge.

DECISION ON APPEAL

1 DePuy Motech Acromed, Inc. and LifeNet Health are the real party in
interest (App. Br. 1).

2 Issued January 28, 2003 to Ford et al. (hereinafter "'509 patent").
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The Appellants (hereinafter collectively "Patent Owner") appeal under
35 U.S.C. §§ 134(b) and 306 (2002) from a Final Rejection of claims 1, 2
and 4-33. Claim 3 has been canceled. We have jurisdiction under 35 U.S.C.
§§ 134(b) and 306 (2002). An oral hearing with the Patent Owner's
representative was held before the Board of Patent Appeals and
Interferences on October 19, 2011, a transcript of which will be made of
record in due course.
The invention is directed to a textured bone allograft which includes
protrusions having a triangular cross-section, and for a method for making
the same. Representative independent claim 1 reads as follows (App. Br.,
Claims App'x.):
1. (Amended) A textured bone allograft comprising: an
upper cut surface, a lower cut surface, and a plurality of
closely spaced protrusions located on each of the upper
and lower cut surfaces, each protrusion comprising a
triangular shaped cross-section.

Independent claim 23 is directed to a method for restoring vertical
support of the anterior column by implanting a textured bone allograph, and
independent claim 24 is directed to a method of making a textured bone
allograft.
The prior art relied upon by the Examiner in rejecting the claims is:
Vich 4,877,020 Oct. 31, 1989
Sires 5,112,354 May 12, 1992
Wagner et al. 5,306,309 Apr. 26, 1994
Thalgott 5,865,845 Feb. 2, 1999
Coates et al. 5,989,289 Nov. 23, 1999
Pafford et al. US 6,371,988 B1 Apr. 16, 2002

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The Examiner rejected claims on appeal as follows:
1. Claims 1, 2, 5, 9, 16, 17, 22 and 23 rejected under 35 U.S.C.
§ 102(b) as anticipated by Vich.
2. Claims 1, 2, 4-8, 10, 16, 17, 22, 23, 25-27, 29 and 30 rejected
under 35 U.S.C. § 102(e) as anticipated by Pafford.
3. Claims 1, 2, 4-6, 8, 16, 17, 22-27, 29, 30 and 33 rejected under
35 U.S.C. § 102(e) as anticipated by Coates.
4. Claims 24, 32 and 33 under 35 U.S.C. § 103(a) as obvious over
Pafford.
5. Claims 11-15, 18-21, 28 and 31 under 35 U.S.C. § 103(a) as
obvious over Pafford and Sires, in view of Thalgott, Wagner and Coates.
We AFFIRM-IN-PART.

ISSUES
The following issues have been raised in the present appeal.
1. Whether the Examiner erred in finding that Vich discloses
upper and lower semi-cylindrical cut surfaces having a plurality of
protrusions.
2. Whether the Examiner erred in finding that Pafford discloses an
allograft having a plurality of closely spaced protrusions.
3. Whether the Examiner erred in finding that the spacers of
Pafford are "bone allografts."
4. Whether the Examiner erred in finding that Pafford discloses an
allograft having a plurality of closely spaced protrusions.
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5. Whether the Examiner erred in finding that Pafford discloses
closely spaced continuous protrusions.
6. Whether the Examiner erred in finding that Figure 27 illustrates
the recited spacing by scaling and reducing the size of the figure.
7. Whether the Examiner erred in finding that the teeth of Figure
40 in Pafford are pyramidal.
8. Whether the Examiner erred in finding that Pafford discloses a
plurality of protrusions that are "provided on at least one entire cut surface"
as recited in claim 17.
9. Whether the Examiner erred in finding that Coates discloses an
allograft having a plurality of closely spaced protrusions, as well as closely
spaced continuous protrusions.
10. Whether the Patent Owner's assertion of unexpected results is
pertinent to the Examiner's rejection based on Coates.
11. Whether the Examiner erred in finding that Coates discloses a
plurality of protrusions that are "provided on at least one entire cut surface"
as recited in claim 17.
12. Whether the Examiner erred in concluding that it would have
been obvious to mill a first set of parallel grooves in the cut surface in view
of Pafford.
13. Whether the Examiner erred in concluding that it would have
been obvious to mill a second set of parallel grooves in the cut surface of
Pafford to make the disclosed teeth.
14. Whether the Patent Owner has established unexpected results of
the claimed invention.
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15. Whether the Examiner erred in concluding that it would have
been obvious to provide on the allograft implants of Pafford, a plurality of
closely spaced pyramidal protrusions in a grid-type pattern as taught by
Thalgott and Wagner.
16. Whether the Examiner erred in concluding that it would have
been obvious to provide a plurality of closely spaced protrusions that are
spaced or dimensioned as specifically recited in claims 11-15 and 18-21.

FINDINGS OF FACT
The record supports the following findings of fact (FF) by a
preponderance of the evidence.
1. A. The Specification of the '509 patent provides definitions for
various terms including: Bone Allograft; Closely Spaced; Continuous
Protrusion; Protrusion; and Textured Bone Allograft (Spec. col. 3, l. 12-col.
4, l. 28).
B. The Specification of the '509 patent also states
The plurality of protrusions can be formed on the surface in any
number of ways well known to those of ordinary skill in the art
to which the present invention pertains, including for example
mechanical and/or chemical methods, including for example, by
forming a series of parallel linear or curved grooves.
(Col. 4, ll. 39-44).

C. The Specification of the '509 patent also states
One of ordinary skill in the art can readily design and produce,
or select, and employ an appropriate milling tool to achieve a
desired textured surface on a bone allograft, without undue
experimentation.
(Col. 4, ll. 63-67).
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2. Vich discloses an apparatus for bone graft. A portion of Figure 4 of
Vich showing the bone graft disclosed therein is reproduced below.

The portion of Figure 4 of Vich reproduced above shows a perspective view
of the helicoidal graft 1 (col. 2, ll. 7-9, 20-25; Fig. 4).

3. A. Pafford discloses bone grafts and spinal spacers. Figures 27, 40
and 41 of Pafford are reproduced below.

Figure 27 of Pafford reproduced above shows a perspective view of
a cortical ring 50' with teeth 56 (col. 10, ll. 10-14, 24-39; Fig. 27).
Figure 40 of Pafford reproduced above shows a perspective view of a
spacer (not numbered) with teeth 205 (col. 13, ll. 10-13; Fig. 40).
Figure 41 of Pafford reproduced above shows a perspective view of a
spacer 210 with blades 212 (col. 13, ll. 13-16; Fig. 41).
B. Pafford states:
This invention also capitalizes on the discovery that cortical
bone, like metal, can be conveniently machined into the various
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shapes disclosed herein. In some embodiments, the load bearing
members define threads on an outer surface. Machined surfaces,
such as threads, provide several advantages that were
previously only available with metal implants. Threads allow
better control of spacer insertion than can be obtained with a
smooth surface. This allows the surgeon to more accurately
position the spacer which is extremely important around the
critical neurological and vascular structures of the spinal
column. Threads and the like also provide increased surface
area which facilitates the process of bone healing and creeping
substitution for replacement of the donor bone material and
fusion. These features also increase post-operative stability of
the spacer by engaging the adjacent vertebral endplates and
anchoring the spacer to prevent expulsion. This is a major
advantage over smooth grafts. Surface features also stabilize the
bone-spacer interface and reduce micromotion to facilitate
incorporation and fusion.
(Col. 7, ll. 1-20).

4. Coates discloses bone grafts. Figures 15 and 19 of Coates are
reproduced below.

Figure 15 of Coates reproduced above is a top elevational view of a spacer
300 having migration resistance grooves 350 (col. 4, ll. 48-49; col. 10, ll. 43-
48; Fig. 15). Figure 19 of Coates reproduced above is a side elevational
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detailed view of the surface of an embodiment of another spacer of Figure
15 (col. 4, ll. 56-57; col. 11, ll. 3-8; Fig. 19).

5. A. Thalgott discloses a prosthetic intervertebral disc. Figure 1 of
Thalgott is reproduced below.

Figure 1 of Thalgott reproduced above shows a perspective view of
a spinal disc implant 10 with a plurality of teeth 20 (col. 2, ll. 27-28,
49-54; Fig. 1).
B. Thalgott discloses that the plurality of teeth is shaped as steeply
sloped four-sided pyramids arranged in rows, and that the teeth "can
be formed by machining the implant 10." (Col. 3, ll. 8-13).

6. Wagner discloses a spinal disk implant. Figure 3 of Wagner is
reproduced below.

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Figure 3 of Wagner reproduced above is a perspective view of a spinal disk
implant 50 having three-dimensional pyramids 76 on the transverse face 68
(col. 4, ll. 32-33; col. 5, ll. 24-26; col. 5, l. 64-col. 6, l. 1; Fig. 3).

PRINCIPLES OF LAW
"A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987). Analysis of whether a claim is patentable over
the prior art under 35 U.S.C. § 102 begins with a determination of the scope
of the claim which is determined not solely on the basis of the claim
language, but upon giving claims their broadest reasonable construction in
light of the specification as it would be interpreted by one of ordinary skill in
the art. In re Prater, 415 F.2d 1393, 1404-05 (CCPA 1969); In re Am. Acad.
of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). This is the standard
for claim interpretation in both original examination and re-examination. See
In re Yamamoto, 740 F.2d 1569, 1571 (Fed. Cir. 1984).

ANALYSIS
Rejection 1: Anticipation Based On Vich
The Examiner rejects claims 1, 2, 5, 9, 16, 17, 22 and 23 as being
anticipated by Vich. According to the Examiner, "Vich implant may be
subdivided by an imaginary plane into upper and lower semi-cylindrical
portions" which have a plurality of cut protrusions (Ans. 3-4). The
Examiner points out that the claims do not recite "basic shape of the
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allograft" so that it would be reasonable to consider the upper and lower
portions of the surface of the Vich implant to correspond to the recited upper
and lower cut surfaces in view of their orientation during use (Ans. 5).
The Patent Owner contends that Vich does not disclose upper and
lower cut surfaces having plurality of protrusions recited because the semi-
cylindrical surfaces "do not actually exist" and Vich actually discloses a
single "helicoidal thread formed on the side wall." (App. Br. 4). According
to the Patent Owner, interpreting the upper and lower cut surface so as to be
satisfied by "a single circumferential cut surface," and interpreting the
plurality of closely spaced protrusions to be satisfied by a single protrusion
is unreasonably broad (App. Br. 5; Reply Br. 4).
We agree with the Patent Owner and find the Examiner's
interpretation of the limitation to encompass the cylindrical surface of Vich
that is "subdivided by an imaginary plane" to be unreasonably broad. In our
view, the recitation "an upper cut surface, a lower cut surface" requires two
separate and distinct surfaces. Vich merely discloses a continuous, single,
cylindrical surface (see FF 2). Correspondingly, we do not sustain the
Examiner's rejection of independent claims 1 and 23, as well as dependent
claims 2, 5, 9, 16, 17 and 22.

Rejection 2: Anticipation Based On Pafford
The Examiner rejects claims 1, 2, 4-8, 10, 16, 17, 22, 23, 25-27, 29
and 30 as being anticipated relying on Figures 27 and 40-42 of Pafford (Ans.
6). As to the limitations requiring the protrusions to be "closely spaced," the
Examiner notes that the Specification of the '509 patent merely defines
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"closely spaced protrusions" as protrusions which are "in close proximity to
each other." (Ans. 7; see Spec., col. 3, l. 28-31). Thus, the Examiner
contends that this limitation is satisfied by the illustrated implants of Pafford
(Ans. 6-7). As to the number of teeth, the Examiner contends that Pafford
teaches "surface roughenings" and provision of teeth is just one example so
that the number of teeth need not be limited to 12 (Ans. 8-9).

Independent Claims 1 and 23
The Patent Owner initially argues that the "spacers" shown in Figures
40 and 41 of Pafford are not "cortical bone allograft implants," and argues
that Pafford teaches that the spacers function to avoid the need for sculpting
grafts of the claimed invention (App. Br. 6, citing Pafford, col. 10, ll. 33-55).
However, the cited portion of Pafford does not state that the disclosed spacer
is not an allograft implant, but rather, merely teaches that use of such spacers
makes the "graft sculpting" procedure unnecessary because the spacers are
provided in known sizes and dimensions (see Pafford, col. 10, ll. 53-55).
We also observe that the claims merely recite a "bone allograft" and that the
Specification of the '509 patent defines "bone allograft" so as to encompass
numerous devices of differing shapes including various types of wedges,
shafts, rings, and dowels, as well as grafts (see Spec., col. 3, ll. 16-27; see
also claim 16). The Patent Owner does not direct us to any persuasive
evidence to establish that one of ordinary skill in the art would not consider
the "spacer" of Pafford to be a "bone allograft" as defined in the '509 patent.
Correspondingly, we find no error in the Examiner's position (Ans. 10) that
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the spacer of Pafford is a "bone allograft" in view of the definition in the
Specification and the lack of persuasive evidence to the contrary.
The Patent Owner also contends that Figure 27 does not show a
"plurality of closely spaced protrusions," but instead, merely shows "12
widely spaced protrusions" so that "most of the surface is not textured, but
rather is flat and smooth." (App. Br. 9). According to the Patent Owner, the
"allografts of the invention are 'preferably textured with a plurality of closely
spaced protrusions over their entire opposing cut surfaces' in order to
provide the[se] surprising advantages." (App. Br. 7, citing Specification of
'509 patent, col. 5, l. 66-col. 6, l. 1; see also Reply Br. 6). The Patent Owner
points to the Specification of the '509 patent as discussing "closely spaced"
protrusions as being apart preferably no more than 3.0 mm, 2.0 mm, 1.5 mm
or most preferably 0.5 mm apart (App. Br. 7, citing col. 3, ll. 28-35). The
Patent Owner also refers to Figures 1A and 1B of the '509 patent as showing
"more than one hundred such protrusions in close proximity substantially
filling the surface to which they are applied[.]" (App. Br. 8; see also Reply
Br. 6).
However, the Patent Owner's arguments directed to Figure 27 does
not overcome the Examiner's finding that Figure 40 also discloses closely
spaced discrete protrusions (Ans. 6), a finding with which we agree (FF 3A).
Furthermore, the Patent Owner's arguments with respect to Figure 27 are
misdirected because the independent claims do not require the plurality of
protrusions to be "over their entire opposing cut surfaces," be apart by a
specific dimension, or require "more than one hundred such protrusions."
See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) ("Many of appellant's
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arguments fail from the outset because, . . . they are not based on limitations
appearing in the claims . . . ."). In addition, according to the Specification,
the spacing of the protrusions is preferably less than 3.0 mm so that such
spacing is not required. We decline to import limitations from embodiments
shown in the Specification into the claims, the claim language being broader
than the embodiment. See Superguide Corp. v. DirecTV Enter., 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."). Furthermore, the Patent Owner's arguments are
directed to subject matter specifically recited in various dependent claims
discussed infra, and based on principles of claim differentiation, we
understand the independent claims 1 and 23 to be broader in scope (see
claims 10-12 and 17).
Finally, while we agree with the Patent Owner (App. Br. 9-10) that
the Examiner should not extract specific spacing dimensions from Figure 27
as discussed infra with respect to various dependent claims, that is not
dispositive with respect to the independent claims in view of the fact that
these independent claims do not recite a specific spacing dimension, and the
Examiner has made a prima facie showing that the protrusions are closely
spaced, giving the claims their broadest reasonable construction consistent
with the specification. In view of the above, we agree with the Examiner
that Pafford anticipates the independent claims. The Patent Owner does not
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separately argue the patentability of dependent claims 2, 4, 7, 16, 22, 25, 26
and 29 with respect to the present anticipation rejection. Hence, these
claims fall as well.

Claims 5 and 8
The Patent Owner separately argues patentability of claims 5 and 8
which ultimately depend from independent claim 1, but further require the
plurality of closely spaced protrusions to be "continuous protrusions." The
Examiner rejected these claims based on Figure 41 of Pafford stating that
considering the "diminutive size" of the implant, the protrusions are "closely
spaced" which is defined in the Specification of the '509 patent as "in close
proximity to each other." (Ans. 7, 9).
The Patent Owner argues that the Examiner erred because Figure 41 is
a "spacer" and not a textured allograft (App. Br. 10). However, this
argument is unpersuasive for the reasons already discussed supra. The
Patent Owner also argues that continuous protrusions of Figure 41 are not
closely spaced since they are positioned at the opposite ends of the device
(App. Br. 11). We agree with the Patent Owner. While recitation of
"closely spaced" is broad, we find it unreasonable in view of the
Specification that such language encompasses two continuous protrusions on
a surface that are positioned on the peripheral edges of the surface so as to
be far away as possible from each other (see FF 3A). In this regard, we
observe that the pertinent limitation recites "a plurality of closely spaced
protrusions located on each of the upper and lower cut surfaces," thereby
tending to support to the Patent Owner's argument in that the limitation
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provides the context of the close spacing, i.e., close to each other on the
surface. Therefore, we do not sustain the Examiner's rejections of claims 5
and 8.

Claim 10
The Patent Owner separately argues the patentability of dependent
claim 10 which depends from claims 1, 2, 4 or 5, and further requires the
closely spaced protrusions to be "spaced from about 0.0 mm to about 3.0
mm apart." (App. Br. 12). The Examiner contends that the implant shown in
Figure 27, when scaled and reduced in size so that it is 15 mm in diameter,
the teeth are about 3 mm apart (Ans. 7, 9-10). The Patent Owner responds
that such resizing and extracting measurements from the drawings are
improper (App. Br. 12).
We agree with the Patent Owner. Drawings can be relied upon for
what they reasonably disclose and suggest to one of ordinary skill in the art.
See In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972); In re Aslanian, 590 F.2d
911, 914 (CCPA 1979). However, "[a]bsent any written description in the
specification of quantitative values, arguments based on measurements of a
drawing are of little value." In re Wright, 569 F.2d 1124, 1127 (CCPA
1977). Hence, the Examiner's finding which only relies on extracted
dimensions from the drawings is of little value and we do not sustain the
rejection of claim 10.

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Claims 6, 27 and 30
The Patent Owner separately argues the patentability of claims 6, 27
and 30 which recite that the protrusions are pyramidal, the Patent Owner
contending that the teeth 205 of Figure 40 is not pyramidal since it does not
show the four sides angling inwardly to reach a peak (App. Br. 12). The
Examiner contends that Figure 40 shows teeth "that are substantially
pyramidal (note that teeth 205 appear as being formed from v-shaped
notches cut into v-shaped linear 'blades,' which thus creates structures
resembling 4-sided pyramids[.]" (Ans. 6, 8). However, we observe that the
present rejection is based on anticipation and the Examiner's finding that the
teeth are "substantially pyramidal" is insufficient to establish anticipation
which requires the presence of "each and every element as set forth in the
claim[.]" Verdegaal Bros., 814 F.2d at 631. In contrast, the teeth of Figure
40 appear to have a straight, vertical surface (FF 3A). Hence, because the
teeth of Figure 40 of Pafford, while shaped similarly to pyramids, are
nonetheless not pyramidal, we do not sustain the Examiner's anticipation
rejection of claims 6, 27 and 30.

Claim 173
The Patent Owner separately argues the patentability of claim 17
which further recites "said plurality of protrusions are provided on at least
one entire cut surface." The Examiner rejected this claim stating "the
protrusions shown on each allograft embodiment discussed above are

3 We observe that claim 17 depends from claim 3 which has been canceled.
The dependency should be corrected in any future prosecution of this claim.
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provided on at least one cut surface." (Ans. 7). The Patent Owner argues
that in the device shown in Figure 27, there are many large flat surfaces, and
the devices shown in Figs. 40-42 have protrusions only along two opposing
edges (App. Br. 13; FF 3A). We agree with the Patent Owner.
The issue is not whether protrusions "are provided on at least one
surface" as characterized by the Examiner, but rather, whether the
protrusions can be said to be "provided on at least one entire cut surface" as
recited in claim 17 (emphasis added). None of the figures of Pafford relied
upon by the Examiner can be reasonably stated as satisfying this limitation
(FF 3A). Thus, we do not sustain the Examiner's anticipation rejection of
claim 17.

Rejection 3: Anticipation Based On Coates
The Examiner rejects claims 1, 2, 4-6, 8, 16, 17, 22-27, 29, 30 and 33
as being anticipated relying on Figures 12, 13, 15 and 19 of Coates (Ans.
10).
Independent Claims 1 and 23
The Examiner rejected the independent claims relying on Figures 12,
13, 15 and 19 of Coates (Ans. 10). The Examiner contends that Figure 12 of
Coates shows "discrete protrusions (teeth 205) that are substantially
pyramidal," while Figures 13 and 19 each show closely spaced "continuous
protrusions" (Ans. 10-11). Coates issued from a continuation-in-part
application of the application that issued as Pafford. In this regard, Figures
12 and 13 of Coates are the same as Figures 40 and 41 of Pafford, and the
Patent Owner refers to the same unpersuasive arguments as those presented
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with respect to the rejection of these independent claims based on Pafford
(App. Br. 13). Further, we also agree with the Examiner that Figure 19 also
illustrates closely spaced "continuous protrusions" in that the parallel
grooves 350 define continuous protrusions therebetween, the arrangement of
which on the surface of the spacer 300 can be reasonably considered to be
closely spaced (FF 4).
The Patent Owner also relies on asserted unexpected results and
statements in the Specification of the '509 patent that "the present inventors
have surprisingly discovered that providing a textured bone graft results in
improved graft stability and osteoinductivity, without a decrease in
mechanical strength." (Ans. 13). However, we observe that the contention
of unexpected results is not pertinent to the present rejection which is based
on lack of novelty. See In re Wiggins, 488 F.2d 538, 543 (CCPA 1973). In
this regard, the fact that those of ordinary skill in the art or the inventors may
not have fully appreciated the improved graft stability and osteoinductivity
does not make the Patent Owner's otherwise anticipated invention
patentable. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed.
Cir. 2002) ("Inherency is not necessarily coterminous with the knowledge of
those of ordinary skill in the art. Artisans of ordinary skill may not
recognize the inherent characteristics or functioning of the prior art."); see
also In re Wiseman, 596 F.2d 1019, 1023 (CCPA 1979) ("[The Appellants]
are, in effect, arguing that a structure suggested by the prior art, and, hence,
potentially in the possession of the public, is patentable to them because it
also possesses an inherent, but hitherto unknown, function which they claim
to have discovered. This is not the law. A patent on such a structure would
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remove from the public that which is in the public domain by virtue of its
inclusion in, or obviousness from, the prior art" (emphasis in original)).
The Patent Owner does not separately argue the patentability of
dependent claims 2, 4, 5, 8, 16, 17, 22, 25, 26 and 29 with respect to the
present anticipation rejection. Hence, these claims fall as well.

Claims 6, 27 and 30
The Patent Owner again separately argues the patentability of claims
6, 27 and 30 which recite that the protrusions are pyramidal (App. Br. 13-
14). We agree with the Patent Owner for the same reasons discussed supra
with respect to the Examiner's anticipation rejection of these claims based on
Pafford. Hence, we do not sustain the Examiner's rejection of claims 6, 27
and 30.

Claim 17
The Patent Owner again separately argues the patentability of claim
17 which further recites "said plurality of protrusions are provided on at least
one entire cut surface." (App. Br. 14). Whereas we agreed with the Patent
Owner that Pafford fails to disclose this limitation, we agree with the
Examiner (Ans. 12) that this limitation is disclosed in Figures 15 and 19 of
Coates. In particular, these figures show a plurality of continuous
protrusions defined by, and positioned between, a plurality of grooves 350,
the protrusions being provided on the entire cut surface (FF 4). Whereas the
Patent Owner argues that "much of the surface that corresponds to the 'cut
surface' is flat" thereby implying that the recited cut surface of Coates is the
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top surface of the protrusions, we see no basis for imposing such a restrictive
meaning to the recited cut surface. The bottom of the plurality of grooves
350 is also cut thereby satisfying the recitation for a "cut surface," and the
material between adjacent grooves protrude from this cut surface of the
grooves (FF 4) so as to satisfy the recited limitation. These protrusions are
provided on the entire cut surface (FF 4) and can reasonably be considered
as closely spaced. Therefore, we are not persuaded that the Examiner erred
in rejecting claim 17.

Rejection 4: Obvious Over Pafford
The Examiner rejects claims 24, 32 and 33 as obvious over Pafford,
these claims reciting that the protrusions are made "by milling a first set of
parallel grooves in the cut surface," and with respect to claim 32, further
milling "a second set of parallel grooves" perpendicular to the first set (Ans.
13). The Examiner relies on the Pafford teaching that bone can be machined
in the same way as metal implants (Ans. 13; FF 3B), and contends that the
formation of the protrusions by milling the first set of parallel grooves on the
upper surface and lower surface as shown in Figures 41-42 is "within the
level of the skilled artisan" (Ans. 14). The Examiner also states that it is
within the level of the skilled artisan to further machine a second set of
parallel grooves to form the teeth 205 of the Figure 40 implant (Ans. 14).
The Examiner also refers to the admission in the Specification of the '509
patent which states that a "[o]ne of ordinary skill in the art can readily design
and produce, or select, and employ an appropriate milling tool to achieve a
desired textured surface." (Ans. 14; FF 1B, 1C). Thus, the Examiner
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concludes "one of ordinary skill in the art could take the Pafford disclosure
and readily employ appropriate milling tools and techniques to produce the
various implants as shown, without undue experimentation." (Ans. 14).
The Patent Owner disagrees and argues that Pafford never discloses
milling (App. Br. 14). The Patent Owner also states that at most, Pafford
mills a single groove in each surface whereas the claimed invention requires
"a set of parallel grooves in each cut surface." (App. Br. 14-15). As to claim
32, the Patent Owner argues that the recited second set of parallel grooves
perpendicular to the first is missing in Pafford. The Patent Owner further
argues that when so milled, it results in an allograft configuration that
provides "surprising results." (App. Br. 16). We are not persuaded that the
Examiner erred.
Firstly, the fact that Pafford does not explicitly mention milling is not
dispositive considering milling is a well-known technique for shaping
metals. The Patent Owner does not provide persuasive evidence as to why it
would not be obvious to a person of ordinary skill in the art to utilize milling
to fabricate bone allografts in view of the teachings in Pafford (which is
directed to bone grafts) that bone can be machined in the same manner as
metal (FF 3B).
Secondly, these claims do not recite "a set of parallel grooves in each
cut surface" as argued by the Patent Owner (emphasis added). Rather, they
merely recite "milling a first set of parallel grooves in the cut surfaces"
which reasonably encompasses milling of a single groove on the upper cut
surface and another single groove on the lower cut surface. While the Patent
Owner refers to the embodiment shown in Figure 1A and discussions thereto
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within the Specification of the '509 patent to argue that the parallel set of
grooves is in each cut surface, the Patent Owner improperly imports
limitations from embodiments shown in the Specification into the claims.
We decline to do so and find the Examiner's interpretation of the claims to
be reasonable. If the Patent Owner intended to claim "a set of parallel
grooves in each cut surface," the Patent Owner should have included this
language in the rejected claims, especially considering the pertinent
limitation was added by amendment or provided in newly added claims.
As to claim 32 and the argument that Pafford does not disclose a
second set of parallel grooves perpendicular to the first set, we observe that
it is the Examiner's position that it would have been obvious to one of
ordinary skill to form the teeth 205 of Figure 40 by further milling grooves
perpendicular to the protrusions of the implant of Figure 41. Whereas the
Patent Owner asserts that the protrusions "are very different," no persuasive
explanation or evidence is provided in support of this assertion, or how any
alleged difference makes the claims unobvious to one of ordinary skill in the
art.
Finally, as to the contention that surprising results attained by the
particular allograph configuration and that the inventors were surprised by
the results as stated in the Specification of the '509 patent (App. Br. 16;
Reply Br. 7-8), we observe that the party asserting unexpected results as
evidence of nonobviousness has the burden of proving that the results are
unexpected. In re Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir. 1997). In
addition, "when unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
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art." In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.Cir.1991); In re
Geisler, 116 F.3d at 1469. In the case before us, while surprising results are
asserted, there is no persuasive evidence to substantiate or support this
assertion. There is also a lack of persuasive evidence that the results are
unexpected when compared with the closest prior art. Correspondingly, the
statements of the inventor in the Specification of the '509 patent is of little
probative value and insufficient to prove that the results are unexpected.
In view of the above, we are not persuaded that the Examiner erred in
rejecting claims 24, 32 and 33 as obvious over Pafford.

Rejection 5: Obvious Over Pafford and Sires, in view of Thalgott,
Wagner and Coates
The Examiner rejects dependent claims 11-15, 18-21, 28 and 31 under
35 U.S.C. § 103(a) as obvious over the combination of Pafford and the noted
references (Ans. 15). Claims 11-15 and 18-21 are directed to the specific
spacing and size of the plurality of protrusions. Claims 28 and 31 recite that
the protrusions are in a "grid-type pattern."
The Examiner concedes that Pafford does not specifically show the
dimensions or the grid-type pattern (Ans. 14-15). However, the Examiner
relies on Pafford for teaching the desirability of shaping and texturing
including benefit of better control of spacer insertion, increased surface area
for facilitating healing, creeping substitution and fusion, stability by
anchoring to prevent expulsion, stabilization of the bone-implant interface,
and reduction in micromotion (Ans. 15-16; FF 3B). The Examiner further
points to Sires for teaching that texturing promotes osteoinduction because
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of the increased surface area (Ans. 16), and Thalgott and Wagner for
teaching spinal implants having discrete pyramidal protrusions in a grid-type
pattern (Ans. 16; FF 5A, 5B, 6). In this regard, the Examiner notes that
Thalgott specifically discloses "steeply sloped four-sided pyramids." (Ans.
17; FF 5B).
Correspondingly, as to claims 28 and 31, the Examiner concludes that
it would have been obvious to one of ordinary skill in the art to modify the
textured surface of Pafford allograft implants to comprise "a plurality of
closely spaced pyramidal protrusions in a grid-type pattern as taught by
Thalgott and Wagner, for the same advantages as explicitly stated in Pafford,
Sires, Thalgott and Wagner . . ." and that the claimed invention merely
substitutes the rows of teeth of Pafford for another to yield predictable
results (Ans. 18). In this regard, the Examiner further argues that the
specific configuration of the protrusions is not shown or asserted to be
critical, also pointing to the Specification of the '509 patent which teaches
numerous different implementations of the protrusions including protrusions
of "any shape." (Ans. 18-19).
Further, as to claims 11-15 and 18-21 that are directed to the specific
spacing and size of the plurality of protrusions, the Examiner concludes that
"in the absence of any disclosed criticality or special functional significance
to the claimed size and spacing of the protrusions, designing and milling any
of the Pafford bone allograft implants as discussed above to have protrusions
of said claimed size and spacing [] would have been obvious to one of
ordinary skill in the art." (Ans. 19-20, parenthetical omitted). We agree with
the Examiner.
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As noted by the Examiner (Ans. 20), mere change in dimension
without functional significance is not patentable. In re Rose, 220 F.2d 459,
463 (CCPA 1955); see also In re Yount, 171 F.2d 317, 318 (CCPA 1949).
Whereas Patent Owner disagrees and cites to the Specification of the '509
patent to contend that "the Patentee surprisingly found superior results in
terms of stability and osteoinductivity from the implants of the invention . .
." (App. Br. 16-17; Reply Br. 7), the cited portion does not mention any
dimensions recited in the rejected claims. Indeed, the Patent Owner does not
specifically argue the dimension recited in these claims, but rather, contends
that "Patentee discovered a new configuration of an allograft implant having
closely spaced, pyramidal protrusions formed to specific dimensions on its
cut surfaces yielded surprising results." (App. Br. 17). However, as
discussed supra, the vague and general statements as to "surprising results"
which are not substantiated with persuasive evidence showing unexpected
results as compared to the closest prior art is inadequate to establish
unobviousness.
In addition, the Patent Owner also points to the fact that Thalgott and
Wagner teach pyramidal teeth in metal or ceramic implants instead of a bone
implant as claimed (App. Br. 16). However, the Patent Owner appears to be
analyzing the prior art references separately where non-obviousness cannot
be established by attacking references individually where the rejection is
based upon the teachings of a combination of references. In re Merck, 800
F.2d 1091, 1097 (Fed. Cir. 1986); In re Keller, 642 F.2d 413, 425 (CCPA
1981). While the materials of the implants in Thalgott and Wagner is not
bone, there is no persuasive evidence or argument in the record that the
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difference in material would dissuade a person of ordinary skill from
utilizing the protrusion geometries as disclosed in Thalgott and Wagner.
Finally, whereas the Patent Owner focuses on osteoinductivity
benefits of the claimed invention, we observe that the evidence indicates,
and the Examiner articulated, that the provision of a plurality of protrusions
provide additional benefits specifically recognized in Pafford such as the
benefit of better control of spacer insertion, increased surface area for
facilitating healing, creep substitution and fusion, stability by anchoring to
prevent expulsion, stabilization of the bone-implant interface, and reduction
in micromotion (FF 3B). In this regard, we observe that the reason or
motivation provided in the prior art to combine the references does not have
to be the same as that of the inventors in order to establish obviousness. In
re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996); KSR, 550 U.S. at 420.
Therefore, in view of the above, we are not persuaded that the
Examiner erred in rejecting claims 11-15, 18-21, 28 and 31 as obvious and
the Examiner's rejection is sustained.

CONCLUSIONS
1. The Examiner erred in finding that Vich discloses upper and
lower semi-cylindrical cut surfaces having a plurality of protrusions.
2. The Examiner did not err in finding that Pafford discloses an
allograft having a plurality of closely spaced protrusions.
3. The Examiner did not err in finding that the spacers of Pafford
are "bone allografts."
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4. The Examiner did not err in finding that Pafford discloses an
allograft having a plurality of closely spaced protrusions.
5. The Examiner erred in finding that Pafford discloses closely
spaced continuous protrusions.
6. The Examiner erred in finding that Figure 27 illustrates the
recited spacing by scaling and reducing the size of the figure.
7. The Examiner erred in finding that the teeth of Figure 40 in
Pafford are pyramidal.
8. The Examiner erred in finding that Pafford discloses a plurality
of protrusions that are "provided on at least one entire cut surface" as recited
in claim 17.
9. The Examiner did not err in finding that Coates discloses an
allograft having a plurality of closely spaced protrusions, as well as closely
spaced continuous protrusions.
10. The Patent Owner's assertion of unexpected results is not
pertinent to the Examiner's rejection based on Coates.
11. The Examiner did not err in finding that Coates discloses a
plurality of protrusions that are "provided on at least one entire cut surface"
as recited in claim 17.
12. The Examiner did not err in concluding that it would have been
obvious to mill a first set of parallel grooves in the cut surface in view of
Pafford.
13. The Examiner did not err in concluding that it would have been
obvious to mill a second set of parallel grooves in the cut surface of Pafford
to make the disclosed teeth.
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14. The Patent Owner did not establish unexpected results of the
claimed invention.
15. The Examiner did not err in concluding that it would have been
obvious to provide on the allograft implants of Pafford, a plurality of closely
spaced pyramidal protrusions in a grid-type pattern as taught by Thalgott and
Wagner.
16. The Examiner did not err in concluding that it would have been
obvious to provide a plurality of closely spaced protrusions that are spaced
or dimensioned as specifically recited in claims 11-15 and 18-21.

ORDERS
1. The Examiner's rejection of claims 1, 2, 5, 9, 16, 17, 22 and 23
under 35 U.S.C. § 102(b) as being anticipated by Vich is
REVERSED.
2. A. The Examiner's rejection of claims 1, 2, 4, 7, 16, 22, 23, 25, 26
and 29 under 35 U.S.C. § 102(e) as being anticipated by Pafford is
AFFIRMED.
B. The Examiner's rejection of claims 5, 6, 8, 10, 17, 27 and 30
under 35 U.S.C. § 102(e) as being anticipated by Pafford is
REVERSED.
3. A. The Examiner's rejection of claims 1, 2, 4-6, 8, 16, 17, 22-27,
29, 30 and 33 under 35 U.S.C. § 102(e) as being anticipated by
Coates is AFFIRMED.
B. The Examiner's rejection of claims 6, 27 and 30 under 35
U.S.C. § 102(e) as being anticipated by Coates is REVERSED.
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4. The Examiner's rejection of claims 24, 32 and 33 under 35 U.S.C.
§ 103(a) as being obvious over Pafford is AFFIRMED.
5. The Examiner's rejection of claims 11-15, 18-21, 28 and 31 under
35 U.S.C. § 103(a) as being obvious over Pafford and Sires, in view
of Thalgott, Wagner and Coates is AFFIRMED.

Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).

AFFIRMED-IN-PART

ack

cc:

For Patent Owner:
Nutter, McClennen & Fish LLP
Seaport West
155 Seaport Blvd.
Boston, MA 002210-2604

For Third Party Requester:
Fitzpatrick, Cella, Harper & Scinto
1290 Avenue of the Americas
New York, NY 10104-3800