Ex Parte Bonutti

Board of Patent Appeals and Interferences

Aug 24, 2009

10793266 (B.P.A.I. Aug. 24, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte PETER M. BONUTTI
____________

Appeal 2009-003420
Application 10/793,266
Technology Center 3700
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Decided: August 24, 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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Application 10/793,266

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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 21-24 and 26-29, 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.

THE INVENTION
Appellant’s claimed invention is to a method of stabilizing tissue.
Representative claim 21, reproduced below, presents the invention as
claimed in greater detail:
21. A method of stabilizing tissue, the method
comprising:

providing a fastener having an elongated body, a
distal portion of the body including a swellable
material, said swellable material being swellable
from an initial volume to an expanded volume, the
distal portion having an unthreaded and
substantially smooth outer surface;

positioning the distal portion of the body in tissue
at a host site with the swellable material having the
initial volume and with the proximal portion of the
body extending from the tissue;

positioning an implant against the tissue such that
the proximal portion of the one-piece body extends
into the implant;
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swelling the swellable material of the distal portion
of the body to the expanded volume while the
body is at the host site; and

fastening the implant to the tissue.

THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Steffee US 4,611,581 Sep. 16, 1986
Draenert US 5,084,050 Jan. 28, 1992
Definitions of “thread” found at AskOxford.com and at
Encarta.msn.com.1
The Examiner has rejected claims 21-24 and 26-29 under 35 U.S.C.
§ 103(a) as being unpatentable over Steffee in view of Draenert. The
Examiner further cites to the two dictionary definitions in support of the
grounds of rejection.

ISSUE
The Examiner found that the Steffee patent discloses each aspect of
the claimed method, with the exception of using a swellable material for the
distal end of the fastener body, and concluded that it would have been
obvious to employ the swellable material disclosed for use in a fastener body
in Draenert in place of the mechanically expandable material disclosed in
Steffee.

1 The Examiner cited to these definitions as evidence supporting the position
that the particular fasteners in the Steffee and Draenert patents relied upon
are not “threaded”. This position is not contested by Appellant.
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Appellant urges that the Steffee and Draenert references do not
disclose a fastener body having a distal portion made of a swellable material,
nor do they disclose a distal portion that is unthreaded and substantially
smooth. More specifically, Appellant contends that the Examiner has
misconstrued the meaning of the terms “distal portion” and “substantially
smooth” in arriving at the findings and the conclusion that the claims are
unpatentable.
The issue joined in this appeal is whether Appellant has shown that
the Examiner erred in finding that the Draenert and Steffee patents disclose
fastener bodies having a distal portion that is substantially smooth, and in
concluding that the Steffee device as modified in view of Draenert would
have a distal portion that is substantially smooth.

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. The Steffee patent discloses a fastener with a substantially
smooth end portion, namely the tip of the Steffee fastener, i.e., the portion of
the fastener that is to the left of the leftmost annular ridge 128 in the
illustration of the device in Figure 14. (Steffee, Fig. 14). The Draenert
patent also discloses a fastener having a substantially smooth tip or distal
portion. (Draenert, Figs. 1, 2).
FF 2. Draenert describes the use of a swellable material for its
expandable anchor, which is particularly effective where the condition of the
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bone is such that normal bone screws will not hold in the bone tissue.
(Draenert, col. 1, l. 57-col. 2, l. 23; col. 2, ll. 53-65).
FF 3. Appellant relies on paragraph [0096] of the Specification,
together with Figure 12 of the application drawings, in support of the
contention that “[T]he specification defines distal portion as the part of the
fastener that is inserted into the tissue.” (Appeal Br. 12). The term “distal”
appears nowhere in that paragraph. The paragraph makes reference to an
“unthreaded portion” that extends into the bone, but the Specification is
devoid of any description or explanation that equates “unthreaded portion”
to “distal portion”, or otherwise establishes that the terms are effectively
synonymous as used by Appellant. (Specification, ¶[0096] and passim).
FF 4. The Specification includes no language or discussion of any
demarcation between, on one hand, a “distal portion” of the fastener that is
precisely (i.e., no more, no less) the portion that is inserted into the tissue,
and, on the other hand, the remainder of the fastener. (Specification,
passim).
FF 5. A common and ordinary meaning of the term “distal” is,
“[A]natomically located far from a point of reference, such as an origin or a
point of attachment”. THE AMERICAN HERITAGE® DICTIONARY OF THE
ENGLISH LANGUAGE (4th ed. 2009). The term “distal portion” of the claimed
fastener body, using this common and ordinary meaning, would thus be a
portion of the claimed fastener body that is located far from a point of
reference.
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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.”).
During prosecution before the USPTO, claim terms are to be given
their broadest reasonable meaning in their ordinary usage as they would be
understood by one of ordinary skill in the art, taking into account whatever
enlightenment by way of definitions or otherwise that may be afforded by
the written description. See In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997); In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). The scope of a claim
cannot be narrowed by reading limitations from disclosed embodiments into
the claim where such limitations have no express basis in the claim. In re
Prater, 415 F.2d 1393, 1404-05 (CCPA 1969).
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ANALYSIS
Claim 21 is the only independent claim presented in this appeal, and is
the only claim to which Appellant’s arguments are directed. Dependent
claims 22-24 and 26-29 thus stand or fall with claim 21.
The Examiner found that the Steffee patent discloses all elements of
the method set forth in claim 21, with the exception that Steffee does not
disclose the use of a swellable material for its fastener or anchor. (Answer
3-4). Of particular significance here, the Examiner found that the Steffee
patent discloses a fastener with a substantially smooth distal portion, namely
the tip of the Steffee fastener, i.e., the portion of the fastener that is to the
left of the leftmost annular ridge 128 in the illustration of the device in
Figure 14, and that the Draenert fastener, too, includes a substantially
smooth distal portion. (FF 1) (Answer 4-5). The Examiner noted that
Steffee does disclose an expandable anchor, and that the Draenert disclosure
describes the use of a swellable material for its expandable anchor, which is
particularly effective in older or elderly patients, where the condition of the
bone is such that normal bone screws will not hold in the bone tissue. (FF
2). The Examiner concluded that it would have been obvious to use the
Draenert swellable anchor in place of the mechanically expandable anchor in
Steffee so as to provide a more effective device for use with older or elderly
patients. (Answer 4).
Appellant counters that the claimed distal portion of the fastener is not
merely a portion of the length that is inserted into the bone tissue, but is, as
assertedly defined in the Specification, the entire length of the fastener that
is inserted into the tissue. Building on this foundation, Appellant argues
that, because the distal portion of the fastener must be regarded as the entire
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portion of the fastener that is inserted into the tissue, Draenert does not teach
or suggest a fastener having a distal portion having a substantially smooth
outer surface that is made of swellable material, and thus the Steffee device,
as modified by Draenert, would also lack a distal portion having a
substantially smooth outer surface. (Appeal Br. 11-12; Reply Br. 2-4). The
distal portion of the Draenert fastener has an undulating surface, according
to Appellant and his proposed interpretation of the term “distal portion”.
Appellant points to paragraph [0096] of the Specification, together
with Figure 12 of the application drawings, in support of the contention that
“[T]he specification defines distal portion as the part of the fastener that is
inserted into the tissue.” (Appeal Br. 11-12). Notably, the term “distal”
appears nowhere in that paragraph. (FF 3). The paragraph refers to an
“unthreaded portion” that extends into the bone. (Id.). The Specification is
devoid of any description or explanation that equates “unthreaded portion”
to “distal portion”, or otherwise establishes that the terms are effectively
synonymous as used by Appellant. (Id.). Similarly, the Specification fails
to demarcate between a “distal portion” of the fastener that is precisely (i.e.,
no more, no less) the portion that is inserted into the tissue, and whatever
constitutes the remainder of the fastener body. (FF 4). As such, Appellant’s
position amounts to nothing more than an attempt to limit the scope of the
claim term to a particular disclosed (illustrated) embodiment.
With the Specification failing to provide a specific definition that
supports Appellant’s contention, the common and ordinary meaning of the
term “distal”, to wit, “anatomically located far from a point of reference,
such as an origin or a point of attachment” (FF 5), is to be used as a guide to
how the claim term “distal portion” is interpreted. The term “distal portion”
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must further be accorded its broadest reasonable interpretation consistent
with how those persons of ordinary skill in the art would understand the
term. In re Morris, 127 F.3d at 1054.
As can be seen from the definition quoted above, depending upon the
point of reference chosen (and Appellant’s Specification is silent in this
respect as well), a “distal portion” need simply be located far from a point of
reference. There is no language in this meaning pertaining to distinguishing
a portion of a device that is inserted in an object from a portion of a device
that is not inserted in the object, as Appellant urges. Further, in the context
of the claim as a whole, the limitation calling for “positioning the distal
portion of the body in tissue at a host site…with the proximal portion of the
body extending from the tissue”, does not mandate that the term “distal
portion” be interpreted as being the entire portion of the fastener body
inserted into the tissue.
The Examiner’s position is that only the tip portion of the Draenert
and Steffee devices are the distal portions of those fastener bodies. (Answer
3-5). Appellant has not demonstrated that this interpretation is in any way
inconsistent with the common and ordinary meaning of “distal” or “distal
portion”, as those terms would be understood by persons having ordinary
skill in the art.
Appellant’s remaining arguments, directed to the cited prior art
allegedly not disclosing or suggesting a fastener body having an unthreaded
distal portion that has a substantially smooth outer surface, are based on the
unsubstantiated position that the Specification defines “distal portion” as
being the entire portion of the fastener that is inserted into the tissue.
Indeed, Appellant acknowledges that the portion of the Draenert device
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which the Examiner cited as the distal portion is smooth:
[F]irst, the Examiner cites the smooth section 14 of
the outwardly projecting tip of the sleeve 10 shown
in Figs. 1-2 of Draenert. This smooth section 14 is
merely a portion of the overall length of the sleeve
10 that is inserted in the bone. In all embodiments
shown and described, the sleeve 10 (i.e. the distal
end inserted in the tissue) of the fastener is always
undulating.
(Appeal Br. 12) (emphasis added).
Appellant’s above argument admits that the portion of the Draenert
device that the Examiner characterizes as the “distal portion” is smooth, and
the remainder of the argument relies on Appellant’s erroneously narrow
view as to how the term “distal portion” should be interpreted. Similarly,
Appellant does not contest the Examiner’s finding that the tip of the Steffee
insert, namely the portion of the insert in Figure 14 that is left of the leftmost
annular ridge 126, is substantially smooth. Appellant takes issue only with
treating less than the entire portion of the fastener body that is inserted in the
tissue as a distal portion of the fastener. As such, we are not persuaded that
error exists in the Examiner’s findings and conclusions directed to the
combined teachings of the prior art disclosing a fastener body having a distal
portion that is unthreaded, swellable, and substantially smooth. The
rejection of claim 21 under 35 U.S.C. § 103(a) will be sustained. Claims 22-
24 and 26-29 fall with claim 21.

CONCLUSION
Appellant has not established that reversible error exists in the
rejections of claims 21-24 and 26-29 under 35 U.S.C. § 103(a).
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ORDER
The decision of the Examiner to reject claims 21-24 and 26-29 is
affirmed.
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

mls

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