Ex Parte Bonutti

Board of Patent Appeals and Interferences

Aug 28, 2009

10793265 (B.P.A.I. Aug. 28, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte PETER M. BONUTTI
____________

Appeal 2009-002183
Application 10/793,265
Technology Center 3700
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Decided: August 28, 2009
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Before LINDA E. HORNER, JOHN C. KERINS and MICHAEL W.
O’NEILL, Administrative Patent Judges.

KERINS, Administrative Patent Judge.
DECISION ON APPEAL
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STATEMENT OF THE CASE
Peter M. Bonutti (Appellant) seeks our review under 35 U.S.C.
§ 134 of the Examiner’s final rejection of claims 31-36 and 43-49, the only
claims pending in the case. We have jurisdiction under 35 U.S.C. § 6(b)
(2002). An oral hearing was conducted on August 13, 2009, with Paul D.
Bianco, Esq., appearing on behalf of Appellant.
SUMMARY OF DECISION
We AFFIRM-IN-PART.

THE INVENTION
Appellant’s claimed invention is to a method for stabilizing tissue in a
human body during surgery. Representative claims 31 and 43, reproduced
below, present the invention as claimed in greater detail:
31. A method for stabilizing tissue in a human
body during surgery, the method comprising:

compressing a core material to a compressed state,
wherein in the compressed state the core material
is reduced in size;

enclosing the core material with a mesh retainer
while the core material is in the compressed state
to form a stabilizing device;

implanting the stabilizing device in the human
body;

expanding the core material of the stabilizing
device by imbibing fluid while the stabilizing
device is implanted in the human body; and

at least partially maintaining the compressed state
of the core material with the mesh retainer while
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the stabilizing device is implanted in the human
body.

43. A method for stabilizing tissue in a human
body during surgery, the method comprising:

removing fluid from a core material;

compressing the core material to a reduced size;

enclosing the core material with a mesh retainer
while fluid is removed from the core material and
while the core material is compressed to form a
stabilizing device, wherein the mesh retainer
maintains the stabilizing device in the reduced
size;

implanting the stabilizing device in the human
body; and

expanding the core material from the reduced size
by imbibing fluid while the stabilizing device is
implanted in the human body.

THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Kurland US 4,400,833 Aug. 30, 1983
McIntyre US 4,950,296 Aug. 21, 1990
Draenert US 5,084,050 Jan. 28, 1992

The Examiner has rejected:
(i) claims 31-33, 35 and 36 under 35 U.S.C. § 103(a) as being
unpatentable over Draenert;
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(ii) claim 34 under 35 U.S.C. § 103(a) as being unpatentable over
Draenert in view of Kurland;
(iii) claims 43-46, 48 and 49 under 35 U.S.C. § 103(a) as being
unpatentable over Draenert in view of McIntyre; and
(iv) claim 47 under 35 U.S.C. § 103(a) as being unpatentable over
Draenert in view of McIntyre and Kurland.
ISSUES
Rejection of claims 31-36
The Examiner found that Draenert discloses a core constituting bone
cylinder 38, bone dowel 10D and the arrangement of spheres shown in the
embodiment of Figures 7-9, and discloses twisting an enveloping stocking
cage to close or reduce the gaps between the spheres which results in
shrinking the volume of, or compressing, the core.
Appellant urges that it is error to consider the core of Draenert as
being made up of the bone cylinder, the bone dowel and the arrangement of
spheres, in that a core must have something different in nature enveloping
the core, and there is nothing remaining in the Draenert structure which
forms an enveloping part or component.
The issue joined here is whether Appellant has demonstrated that the
Examiner’s finding that the core in Draenert being made up of the bone
cylinder, the bone dowel and the arrangement of spheres is in error.
Rejection of claims 43-49
The Examiner concluded that, despite the absence of a teaching in
Draenert of performing a method that includes a step of removing fluid from
an autograft bone material in the core material or using a dried core, it would
nevertheless have been obvious to include such a step to provide the best
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expansion potential possible, and would have been obvious in view of the
teachings of McIntyre to prepare a bone allograft material for use as the
bone cylinder material 38 in Draenert which is freeze-dried or lyophilized to
remove fluid therefrom, so as to obtain a bone cylinder material that is
selected, cleaned, treated and preserved.
Appellant argues that McIntyre does not disclose or suggest that the
freeze-drying or lyophilization of the bone allograft material therein leads to
a compression in the size of that material, and further that Draenert does not
disclose or suggest that the volume of the bone cylinder used therein is to
undergo any change in size or volume as employed in that device.
The issue to be decided here is whether Appellant has shown that the
Examiner erred in concluding that it would have been obvious to perform
the Draenert process with the additional step of removing fluid from the core
material.
FINDINGS OF FACT
The following enumerated findings of fact (FF) are supported by at
least a preponderance of the evidence. Ethicon, Inc. v. Quigg, 849 F.2d
1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for
proceedings before the Office).
FF 1. Draenert discloses that a bone implant may be made up of a
framework of , “[L]oose spheres 40 [that] are held in place in a double-
walled stocking cage 42”, and that the spheres, “can be brought into close,
mutual contact by turning stocking cage 42.” (Draenert, col. 8, ll. 55-59;
Figs. 7-9).
FF 2. The McIntyre patent does not teach that the freeze-drying or
lyophilization process brings about compression or reduction in size of the
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allograft, nor does it disclose that imbibing the graft with fluid will expand
the material. (McIntyre, passim).
FF 3. Draenert does not disclose that the bone cylinder 38 is to
undergo any change in size or volume as employed in the Draenert
construction. (Draenert, passim).

PRINCIPLES OF LAW
A claim is unpatentable for obviousness under 35 U.S.C. § 103(a) if
“the differences between the subject matter sought to be patented and the
prior art are such that the subject matter as a whole would have been obvious
at the time the invention was made to a person having ordinary skill in the
art to which said subject matter pertains.” See, KSR Int'l Co. v. Teleflex Inc.,
550 U.S. 398, 406 (2007). The question of obviousness is resolved on the
basis of underlying factual determinations including (1) the scope and
content of the prior art, (2) any differences between the claimed subject
matter and the prior art, (3) the level of skill in the art, and (4) where in
evidence, so-called secondary considerations. Graham v. John Deere Co.,
383 U.S. 1, 17-18 (1966). See also KSR Int’l., 550 U.S. at 406-07 (“While
the sequence of these questions might be reordered in any particular case,
the [Graham] factors continue to define the inquiry that controls.”).
ANALYSIS
Claims 31-33, 35 and 36--Obviousness—Draenert
The Examiner found that the Draenert patent discloses all of the steps
set forth in the method of claim 31, with the exception that a core material is
not enclosed within a mesh retainer while the core material is in a
compressed state. More specifically, the Examiner found that Draenert
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discloses a core material made up of bone cylinder 38, bone dowel 10D and
the spheres shown in the embodiment of Figures 7-9. (Answer 3). The
Examiner further found that the stocking 42 compresses the spheres when
the stocking is twisted. (Id.). The Examiner further found that it would have
been obvious to modify the Draenert process for constructing the stabilizing
device by compressing the core prior to applying the stocking, as this
amounts to a simple separation of two steps that, as disclosed in Draenert,
are performed in a single step. (Answer 3-4).
Appellant counters the rejection, contending (1) that the Examiner
erred in employing an improper definition of “compress”; (2) that the
Examiner’s finding as to what constitutes the “core” in Draenert is
erroneous; and (3) in view of the erroneous determination of what
constitutes the core in Draenert, and applying Appellant’s interpretation as to
what structure in Draenert should be regarded as constituting the core, (a)
that the Draenert patent nowhere discloses that a core is shrunk or reduced in
volume by compression, and (b) that Draenert does not suggest a
compressible core. (Appeal Br. 11-13; Reply Br. 4-5).
The Examiner’s cites to definitions taken from two online dictionaries
(Merriam Webster Online Dictionary and MSN Encarta) in support of the
position that the root word “compress” of the claim term “compressing”
should be interpreted, in its broadest reasonable interpretation, as meaning
“to press things together”. (Answer 3). Appellant, citing to the same
dictionary definitions, takes the position that the terms “compress” and
“compressing” should be interpreted as requiring a volumetric change,
namely a shrinking or a reduction in size. (Appeal Br. 12). We need look
no further than the language of claim 31 itself to resolve this issue. Claim
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31 requires a step of compressing a core material, “wherein in the
compressed state the core material is reduced in size.” (Appeal Br., Claims
Appendix, Claim 31). As such, the term “compressing” requires some
reduction in size of the claimed core.
This apparent error on the Examiner’s part does not, however, amount
to reversible error. After stating and reiterating the position that the term
“compress” only requires the pressing of things together, the Examiner
further states that,
[F]urthermore, pressing loose material together (as
in Draenert) would inherently shrink the core
volume as gaps between the particles are reduced
or eliminated in size. For this reason, Draenert
compresses his core…
(Answer 6).
As noted previously, the Examiner took the position that the core
material of Draenert is made up of bone cylinder 38, bone dowel 10D and
the spheres shown in the embodiment of Figures 7-9. The reference in the
above quote to “loose material” is to the “[L]oose spheres 40” that, as
disclosed in Draenert, “can be brought into close, mutual contact by turning
stocking cage 42.” (FF 1). The Examiner thus has pointed to evidence that,
in Draenert, the core is “compressed” (shrunk or reduced in size) as called
for in claim 31.
Appellant does not argue that bringing the spheres of Draenert into
close mutual contact does not amount to a compression of that component.
Appellant’s attack on the Examiner’s position is instead that the elements in
Draenert that the Examiner regards as collectively constituting the core can
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not properly be considered to be a core.1 Appellant contends that the
Examiner’s interpretation of what constitutes a core in Draenert “violates the
meaning of ‘core’”. (Reply Br. 4). Appellant asserts that only the bone
cylinder 38 of Draenert constitutes its core, and that Draenert does not teach
or suggest compressing the bone cylinder. (Id.).
Appellant principally relies on a dictionary definition of “core” as
meaning “a central and often foundational part usually distinct from the
enveloping part by a difference in nature”.2 Appellant contends that if, as
asserted by the Examiner, the bone cylinder, bone dowel, and spheres
disclosed in the Draenert patent all form the core, “then there is nothing
remaining to form an enveloping part…”. (Appeal Br. 14). The Examiner
points out in reply that Draenert further includes a knitted stocking cage
which envelops the core. (Answer 7). Appellant’s Reply Brief, which
focuses (for this rejection) exclusively on the alleged error in interpreting
what the core of Draenert consists of, addresses this finding by stating:
[C]ore is not a relative term (i.e. the beads are not
a core relative to the mesh). Something is either

1 This is not clearly articulated in Appellant’s arguments directed to claim 31
in the Appeal Brief, which are essentially blanket statements that,
“[N]owhere in Draenert ‘050 is the core taught to be shrunk or reduced in
volume”, and, “Draenert ‘050 does not suggest a compressible core”.
(Appeal Br. 12). Appellant’s arguments directed to claims 31-33, 35 and 36
in the Reply Brief, and to dependent claim 32 in the Appeal Brief, evince
that it is the scope of the claim term “core” that is at the heart of Appellant’s
assignment of error.

2 Appellant asserts that this definition appears in “Merriam Webster’s
dictionary”, without providing any details as to which edition of which
dictionary published by Merriam-Webster that the definition was excerpted
from. The Evidence Appendix to the Appeal Brief also fails to include a
copy of relevant pages excerpted from this reference source.
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the core or it is not the core. In the case of
Draenert ‘050 (see especially Figs. 6-7), the
spheres 40 are not the core; the dowel [sic., bone
cylinder] 38 is the core.

…to interpret the dowel as the core would mean
that there is no surrounding structure. … a core
implies a requirement of an enveloping part.

(Reply Br. 5).
These assertions do not persuade us that the Examiner erred in finding
that the term “core” in claim 31, in its broadest reasonable interpretation, is
met by the bone cylinder, bone dowel, and spheres structure disclosed in
Draenert. Appellant has not refuted the Examiner’s finding that the knitted
stocking cage of Draenert is a surrounding or enveloping element to the core
structure.
Appellant’s remaining arguments to the effect that the Draenert patent
nowhere discloses that a core is shrunk or reduced in volume by
compression, and that Draenert does not suggest a compressible core, rely
upon Appellant’s own interpretation that, in Draenert, only the bone cylinder
38 is the core. Appellant asserts that, “Draenert ‘050 does not teach or
suggest compressing the core, i.e. the bone cylinder 38”, and that, “Draenert
‘050 does not teach to compress the core, which in Draenert ‘050 is the bone
cylinder 38.” (Reply Br. 5). These contentions miss the mark, as they are
based upon an erroneously narrow interpretation of the scope of the claim
term “core”.
We will sustain the rejection of claim 31 under 35 U.S.C. § 103(a)
over Draenert. Claims 33, 35 and 36 are not separately argued, and thus fall
with claim 31. Claim 32 was separately argued in the Appeal Brief (Appeal
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Br. 14), but the reason advanced for patentability was that the Examiner’s
interpretation of the term “core” is unreasonably broad. That contention is
essentially the same contention as is made with respect to claim 31, and we
are not persuaded of error in the Examiner’s position. The rejection of claim
32 will be sustained.

Claim 34--Obviousness--Draenert in view of Kurland
Appellant does not present any arguments that are different from those
presented for claim 31 in contesting this rejection. (Appeal Br. 15). As with
claim 31, we are not persuaded that the Examiner erred in determining
which components of Draenert are responsive to the claimed “core”, and that
this core is compressible and is compressed. The rejection of claim 34 will
be sustained.

Claims 43-46, 48 and 49--Obviousness--Draenert in view of McIntyre
The Examiner found that the Draenert patent does not disclose a
method in which fluid is removed from a core material, one of the steps
recited in claim 43. (Answer 4). The Examiner concluded that, because the
Draenert implant relies on absorbing water or body fluids to expand, once
inserted in the tissue, it would have been obvious to dry out or desiccate the
implant prior to packaging and use, so that the best expansion potential
could be achieved. The Examiner asserts that the McIntyre patent teaches
freeze-drying or lyophilizing bone allograft material to be used in implants,
and that it therefore would have been obvious to remove fluid from, or
freeze-dry, a bone allograft material and use the same as the bone cylinder
material in the Draenert construction, because McIntyre teaches that
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allograft material so treated is “selected, cleaner [sic., cleaned], treated and
preserved”. (Answer 5).
While Draenert does teach a physical compressing of the core (using
the Examiner’s interpretation), there is nothing to suggest that this
compressing could or should involve removing fluid from the core material.
As noted by Appellant, the McIntyre patent does not teach or suggest that
the freeze-drying or lyophilization process brings about compression or
reduction in size of the allograft, nor does it disclose or suggest that
imbibing the graft with fluid will expand the material. (FF 2). Appellant
further notes that Draenert does not teach or suggest that the bone cylinder
38 is to undergo any change in size or volume as employed in the Draenert
construction. (FF 3) (Reply Br. 6).
Taking these considerations into account, we are persuaded that the
Examiner erred in concluding that it would have been obvious to perform a
method using the Draenert construction in which fluid is removed from the
core material. The rejection of claims 43-46, 48 and 49 under 35 U.S.C. §
103(a) over Draenert in view of McIntyre will not be sustained.
Claim 47--Obviousness--Draenert in view of McIntyre and Kurland
Claim 47 depends from claim 43, and thus also includes the method
step of removing fluid from a core material. As discussed above, the
combination of teachings of Draenert and McIntyre do not render obvious a
method including this limitation. The Kurland patent is not relied on by the
Examiner as teaching a step of removing fluid from a core, and we do not
find any teaching or suggestion of this in Kurland. Kurland thus does not
remedy the deficiency of the Draenert and McIntyre references in rendering
obvious the subject matter of claim 47. The rejection of this claim under 35
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U.S.C. § 103(a) will not be sustained.
CONCLUSION
Appellant has not established that reversible error exists in the
rejections of claims 31-36 under 35 U.S.C. § 103(a).
Appellant has established that reversible error exists in the rejections
of claims 43-49 under 35 U.S.C. § 103(a).
ORDER
The decision of the Examiner to reject claims 31-36 is affirmed. The
decision of the Examiner to reject claims 43-49 is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2007).

AFFIRMED-IN-PART

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LV

PAUL D. BIANCO
FLEIT GIBBONS GUTMAN BONGINI & BIANCO, PL
21355 EAST DIXIE HIGHWAY
SUITE 115
MIAMI, FLORIDA 33180