Ex Parte Schlienger et al

Patent Trial and Appeal Board

Nov 13, 2012

11301760 (P.T.A.B. Nov. 13, 2012)

MOD PTOL-90A (Rev.06/08)

APPLICATION NO./
CONTROL NO.
FILING DATE FIRST NAMED INVENTOR /
PATENT IN REEXAMINATION
ATTORNEY DOCKET NO.
11/301,760 12/12/2005 Andre Schlienger et al.

EXAMINER
FAY KAPLUN & MARCIN, LLP
150 BROADWAY, SUITE 702
NEW YORK, NY 10038

COTRONEO, STEVEN
ART UNIT PAPER NUMBER
3733
MAIL DATE DELIVERY MODE

11/15/2012 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.

UNITED STATES DEPARTMENT OF COMMERCE
U.S. Patent and Trademark Office
Address : COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________________________________________________________________________________

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ANDRE SCHLIENGER, MARKUS BUETTLER,
PETER SENN, and CHRISTIAN RAEHLE
__________

Appeal 2012-000680
Application 11/301,760
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
intramedullary nail. The Examiner rejected the claims as anticipated. We
have jurisdiction under 35 U.S.C. § 6(b). We reverse.

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Application 11/301,760

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Statement of the Case
Background
“The invention relates to a surgical nail, especially to a hollow
intramedullary nail with a longitudinal central axis and at least one
transverse borehole, and having a rod-shaped insert adapted for insertion
within the hollow of the intramedullary nail in the region of the transverse
borehole” (Spec. 1 ¶ 0002).
The Claims
Claims 1-20 are on appeal. Claim 1 is representative and reads as
follows:
1. An intramedullary nail comprising:
a nail body having a central axis, a proximal end, a
distal end, and a wall surrounding a longitudinal bore
extending along the central axis, the nail body formed of a
material M;
a plurality of transverse boreholes extending
transversely to the central axis, each transverse borehole
having a cross-sectional profile F and a transverse axis,
where the cross-section F has a maximum length a in the
direction of the central axis and a maximum width b
perpendicularly thereto; and
an elongate insert configured and dimensioned for
insertion along the central axis into the longitudinal bore of
the nail in the area of the transverse boreholes, the insert
having a longitudinal axis and formed of a material m along
an entire length thereof and including an expansion at a
distal end thereof, the material m having a modulus of
elasticity e less than a modulus of elasticity E of the nail
material M, and the expansion having a cross-sectional area
larger than a cross-sectional area of the longitudinal bore at
the distal end of the nail body to prevent the expansion from
moving proximally into the longitudinal bore.

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Application 11/301,760

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The issue
The Examiner rejected claims 1-20 under 35 U.S.C. § 102(e) as
anticipated by Hover
1
(Ans. 4-6).
The Examiner finds that:
Hover et al. discloses an intramedullary nail (see figs
11, 15 and 18 below) comprising: a nail body (fig 15, 322)
having a central axis, a proximal end, a distal end, and a wall
surrounding a longitudinal bore (fig 15, 34) extending along
the central axis, the nail body formed of a material M (col. 6,
ll. 25, titanium); a plurality of transverse boreholes (fig 2,
40, 50 and 60) extending transversely to the central axis,
each transverse borehole having a cross-sectional profile F
and a transverse axis, where the cross-section F has a
maximum length a in the direction of the central axis and a
maximum width b perpendicularly thereto; and an elongate
insert (fig 15, 346) configured and dimensioned for insertion
along the central axis into the longitudinal bore of the nail in
the area of the transverse boreholes, the insert having a
longitudinal axis and formed of a material m along an entire
length thereof, the material m having a modulus of elasticity
e less than the modulus of elasticity E of the nail material M.

(Ans. 4-5.)
Appellants contend that “Hover discloses an intramedullary nail
including an insert 356 which either has a uniform diameter or a slightly
larger diameter between the proximal and distal end” (App. Br. 6).
Appellants contend that Hover‟s nail is “structurally different than the
claimed insert which „includes an expansion at a distal end thereof‟ which
has „a cross-sectional area larger than a cross-sectional area of the

1
Hover et al., US 6,783,529 B2, issued Aug. 31, 2004.
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Application 11/301,760

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longitudinal bore at the distal end of the nail body to prevent the expansion
from moving proximally into the longitudinal bore‟” (id.).
Appellants contend that:
The second embodiment illustrated in Figs. 15 - 16
may show the spacer 346 that is axially inserted, but the
spacer 346 includes no expansions. It appears that the
Examiner arbitrarily draws a dotted line and states that the
radial extension therefrom illustrates the expansion. It is
unclear the basis for the Examiner's assertion. In its entirety,
Hover includes no disclosure that the insert 346 includes this
expansion. Furthermore, it appears that this purported
expansion extends across an entire longitudinal length of the
insert 346. Therefore, even if Hover discloses that this
expansion exists (which is clearly not the case), the
expansion is not “at a distal end [of the insert],” as recited in
claim 1.

(Id. at 8.)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner‟s conclusion that Hover anticipates claim 1?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. The Specification teaches that a “rod-shaped insert 7 (Fig. 3), in
the form of a one-piece solid of absorbable polylactide, is inserted into this
longitudinal borehole 3” (Spec. 8 ¶ 0039).
2. The Specification teaches that the “insert 7 has a longitudinal
borehole 8 . . . [a]t its distal end, it has a hemispherical expansion 11 with a
proximally directed stop 10. A secure, axial positioning of the insert 7 in the
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Application 11/301,760

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longitudinal borehole 3 of the medullary nail is guaranteed by the stop 10 of
the expansion 11” (Spec. 8 ¶ 0041).
3. Figures 1 and 3 of the Specification are reproduced below:

“Fig. 1 shows a longitudinal section through a hollow medullary nail,
partially filled with a softer material . . . Fig. 3 shows an insert of a
biocompatible plastic” (Spec. 7 ¶¶ 0031, 0033).
4. Hover teaches “intramedullary nails used for treatment of a
fracture of a bone having a medullary canal extending longitudinally within
the bone, and particularly to the structure of the intramedullary nail and
methods for anchoring the intramedullary nail with respect to one or more
fragments of the fractured bone” (Hover, col. 1, ll. 18-23).

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5. Figure 15 of Hover is reproduced below:

“FIG. 15 shows the axial insert 356 aligned for axial insertion into a
corresponding insert reception recess 386 in a distal end 26 of a nail
structure 322” (Hover, col. 15, ll. 23-25).
6. Hover teaches that:
If desired, the axial insert 356 may be formed with a
spacer portion 346 which is slightly larger in diameter than
the distal extension 390. For instance, the distal extension
390 may be formed with a diameter which matches the
diameter of the receiving opening 386, and the spacer
portions 346 of the axial insert 356 may be formed having a
diameter which is 2 to 10 mils larger and in the shape of the
windows 44. With such a configuration, axial insertion of
the axial insert 356 into the receiving opening 386 is only
achieved with a press force which compresses the spacer
portion 346 of the axial insert 356 radially inward. Then,
when fully inserted into the nail structure 322, the spacer
portion 346 uncompresses and springs radially outward into
the windows 44, locking the axial insert 356 from sliding
distally in the nail structure 322.

(Hover, col. 16, ll. 19-33.)

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Principles of Law
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005).
Analysis
Claim 1 requires a nail with a longitudinal borehole and an insert
which will enter the longitudinal borehole but whose distal end has “a cross-
sectional area larger than a cross-sectional area of the longitudinal bore at
the distal end of the nail body to prevent the expansion from moving
proximally into the longitudinal bore” (Claim 1).
The plain language interpretation of this requirement in claim 1 is that
the insert will fit into the longitudinal borehole, but the distal end of the
insert has a large enough diameter so that the distal end portion won‟t fit into
the internal diameter of the longitudinal borehole. Instead, the distal end of
the insert will prevent further movement of the insert into the nail‟s
longitudinal borehole.
The Examiner correctly finds that Hover teaches a nail (FF 4) with a
longitudinal borehole and an “axial insert 356 aligned for axial insertion into
a corresponding insert reception recess 386 in a distal end 26 of a nail
structure 322” (Hover, col. 15, ll. 23-25; FF 5). However, in the teaching of
Hover identified by the Examiner at col. 16, Hover teaches an insert with “a
spacer portion 346 which is slightly larger in diameter than the distal
extension 390” (Hover, col. 16, ll. 19-21; FF 6). This larger diameter spacer
portion 346 is not, however, used to prevent or limit movement of insert into
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Application 11/301,760

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the borehole, but rather is press fitted into the borehole so that “when fully
inserted into the nail structure 322, the spacer portion 346 uncompresses and
springs radially outward into the windows 44, locking the axial insert 356
from sliding distally in the nail structure 322” (Hover, col. 16, ll. 30-33; FF
6). Consequently, the spacer portion 346 cannot reasonably be interpreted as
a distal end preventing movement into the bore, when the spacer portion is
forced into the bore (FF 6). We also agree with Appellants that the portion
346 is at the proximal end of the insert, not the distal end as required by
claim 1. We note that the distal extension 390 may remain outside of the
borehole, but this distal extension matches the diameter of the borehole
opening 386 (FF 6) and therefore cannot satisfy the claim requirements for a
distal end which has an increased diameter and prevents movement into the
borehole.
We also agree with Appellants that the embodiments illustrated in
Figs. 11 and 18 of Hover also do not satisfy the requirements of claim 1
(Reply Br. 4).
Conclusion of Law
The evidence of record does not support the Examiner‟s conclusion
that Hover anticipates claim 1.
SUMMARY
In summary, we reverse the rejection of claims 1-20 under 35 U.S.C.
§ 102(b) as anticipated by Hover.

REVERSED
cdc