Ex Parte NARDINI et al

Patent Trial and Appeal Board

Oct 30, 2018

13523227 (P.T.A.B. Oct. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/523,227 06/14/2012 Reto NARDINI
76960 7590 10/30/2018
Fay Kaplun & Marcin, LLP
150 Broadway, suite 702
New York, NY 10038
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
10139/26603 1084
EXAMINER
MATTHEWS, TESSA M
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
10/30/2018 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 PATENT TRIAL AND APPEAL BOARD
Ex parte RETO NARDINI, ALFRED NIEDERBERGER,
AZAGEN MOOTIEN, and FRANK WILSON 1
Appeal2017-003892
Application 13/523,227
Technology Center 3700
Before MICHAEL J. FITZPATRICK, TA WEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
intramedullary device, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
STATEMENT OF THE CASE
The Specification states:
Intramedullary nails are inserted into medullary canals of
long bones to fix fractures thereof. Once inserted into a
medullary canal, an intramedullary nail is generally fixed
1 Appellants identify the Real Party in Interest as DePuy Synthes Products,
Inc. (Appeal Br. 2.)
Appeal2017-003892
Application 13/523,227
therein by inserting one or more bone fixation elements
through locking holes extending transversely through the
nail. The curvature of a medullary canal often deviates
from the initial curvature along which the nail extends so
that the nail is deformed during insertion. This
deformation moves the transverse locking holes away
from their expected position making it difficult to drill the
holes required to insert the locking screws therein.
(Spec. ,r 2.) According to the Specification,
[ e ]xemplary embodiments of the present invention
describe an intramedullary device including an
intramedullary nail and a fixation wire inserted into a
channel of the nail such that a distal end of the wire
extends out of a distal hole of the nail. Thus, the
intramedullary nail may be fixed to the bone from within
the nail via the wire such that additional incisions and bone
drilling are not required.
(Id. ,I 5.)
Claims 1, 2, 4--17, 19--22, and 24--26 are on appeal. Claims 1 and 20
are illustrative and reproduced below:
1. An intramedullary device, comprising:
an intramedullary nail extending along a
longitudinal axis from a proximal end to a distal end, the
nail including a channel extending longitudinally
therethrough and an opening extending laterally through
a wall thereof proximate the distal end, the channel
including a ramped surface along a distal portion thereof
opposite the opening; and
a wire extending along a longitudinal axis from a
proximal end to a distal end, the wire sized and shaped to
be inserted into the channel of the nail such that the distal
end engages the ramped surface to extend through the
opening, wherein the wire includes a stop extending
radially outward therefrom to engage a shoulder of the
channel, and a diameter of the channel proximal of the
2
Appeal2017-003892
Application 13/523,227
shoulder is larger than a diameter of the channel distal of
the shoulder.
20. An intramedullary device, comprising:
an intramedullary nail extending along a
longitudinal axis from a proximal end to a distal end, the
nail including a channel extending longitudinally
therethrough and an opening extending laterally through
a wall thereof proximate the distal end; and
a wire extending along a longitudinal axis from a
proximal end to a distal end, the wire sized and shaped to
be inserted into the channel of the nail such that the distal
end extends through the opening, the distal end having a
diameter that is larger than a diameter of a remaining
length of the wire to form a natural bend in the wire,
wherein the wire includes a stop extending radially
outward therefrom to engage a shoulder of the channel.
(Appeal Br. 16, 19--20 (Claims App.).)
The Examiner rejects claims 1, 2, 5-8, 11, and 12 under pre-AIA 35
U.S.C. § I03(a) as being unpatentable over Emilio2 and James. 3 (Final Act.
2.)
The Examiner rejects claims 9 and 10 under pre-AIA 35 U.S.C.
§ 103 (a) as being unpatentable over Emilio, James, and Ferrante. 4 (Final
Act. 6.)
The Examiner rejects claims 4, 20-22, and 24--26 under pre-AIA 35
U.S.C. § 103(a) as being unpatentable over Emilio, James, and Monfardini. 5
(Final Act. 7 .)
2 Emilio et al., US 5,814,047, issued Sept. 29, 1998.
3 James et al., US 5,569,249, issued Oct. 29, 1996.
4 Ferrante et al., US 2003/0187447 Al, published Oct. 2, 2003.
5 Monfardini, EP O 922 437 Al, published June 16, 1999.
3
Appeal2017-003892
Application 13/523,227
The Examiner rejects claims 13-15 and 19 under pre-AIA 35 U.S.C.
§ 103(a) as being unpatentable over Emilio and Bramlet. 6 (Final Act. 12.)
The Examiner rejects claims 16 and 17 under pre-AIA 35 U.S.C.
§ 103(a) as being unpatentable over Emilio, Bramlet, and Maale. 7 (Final
Act. 15.)
I.
Issue
The Examiner rejects claims 1, 2, 5-8, 11, and 12 as obvious over
Emilio and James. The Examiner rejects claims 9 and 10 as obvious over
Emilio, James, and Ferrante. The Examiner rejects claims 13-15 and 19 as
obvious over Emilio and Bramlet. The Examiner rejects claims 16 and 17 as
obvious over Emilio, Bramlet, and Maale. The same issues are dispositive
for these rejections; we therefore discuss these rejections together.
The Examiner finds that Emilio teaches all of the elements of claim 1,
except that it does not teach an intramedullary nail comprising "[a] wire
includ[ing] a stop extending radially outward therefrom to engage a shoulder
of [a] channel" of the intramedullary nail, wherein "a diameter of the
channel proximal of the shoulder is larger than a diameter of the channel
distal of the shoulder," as recited in claim 1. (Ans. 2-3.) The Examiner
finds, however, that James teaches an intramedullary nail meeting these
limitations. (Id. at 3.) The Examiner concludes that
[i]t would have been obvious to one having ordinary skill
in the art at the time the invention was made to modify the
channel and wire of Emilio et al. such that the wire
includes a stop extending radially outward therefrom to
6 Bramlet, US 5,976,139, issued Nov. 2, 1999.
7 Maale, US 4,653,487, issued Mar. 31, 1987.
4
Appeal2017-003892
Application 13/523,227
engage a shoulder of the channel and wherein the channel
proximal of the shoulder is larger than a diameter of the
channel distal of the shoulder, as taught by James, to better
securing the wire and nail together thereby preventing
unwanted movement.
(Id. at 3--4.)
Appellants contend that the cited prior art combination does not
disclose an intramedullary nail comprising "a channel including a ramped
surface along a distal portion thereof opposite [an] opening [ extending
laterally through a wall thereof proximate to the distal end]." (Appeal Br. 6-
9; Reply Br. 3---6.)
The issue with respect to these rejections is whether Emilio discloses
an intramedullary nail comprising "a channel including a ramped surface
along a distal portion thereof opposite [an] opening [ extending laterally
through a wall thereof proximate to the distal end]."
Analysis
We find Appellants to have the better argument. We begin by
construing the claim limitation, "the channel including a ramped surface
along a distal portion thereof opposite the opening." An ordinary meaning
of opposite is "at the other end or side of an intervening space. " 8 Thus, we
conclude that the ordinary meaning of the limitation, "the channel including
a ramped surface along a distal portion thereof opposite the opening,"
requires the channel to have a ramped surface at the other side of the channel
(i.e., across the channel) from the opening.
8 See, e.g., "opposite." J\,1ERRIAM-vVEBSTER, https://www.merriam-
webster.com/dictionary/opposite (last visited Oct. 19, 2018) (defining
opposite as "set over against something that is at the other end or side of an
intervening ... line or space").
5
Appeal2017-003892
Application 13/523,227
To clarify our construction, an annotated version of Figures 3 and 4 of
the Specification is reproduced below:
FIG. 4
The annotated Figures 3 and 4 reproduced above show longitudinal cross-
sectional views of a portion of an intramedullary nail according to the
invention, annotated to indicate the locations of the "ramped surface ...
opposite the opening 106" as recited in claim 1 according to our construction
of that limitation. (Spec. ,r 4.)
We note that the Specification also supports our ordinary meaning
construction of this limitation. In describing the ramp portion of the
6
Appeal2017-003892
Application 13/523,227
channel, for instance, the Specification states: "The ramped portion 118 of
the channel 108 is formed on a side of the channel 108 opposite the distal
hole 106 and angled toward distal 106 so that, as the distal end 112 engages
the ramped portion 118, the distal end of the wire 104 passes into the distal
hole 106." (Spec. ,r 12.) In short, contrary to the Examiner's apparent
construction, the ramped surface recited in claim 1 is located on a side of the
channel rather than, e.g., in the middle of the channel.
Having construed the limitation "the channel include a ramped surface
along a distal portion thereof opposite the opening," we agree with
Appellants that the Examiner has not established a prima facie case that the
combination of Emilio and James suggests this limitation. To facilitate our
discussion, we reproduce Figure 10 of Emilio below:
N
(~) ' . ' s ·-, y~ ' '> s (\
. J-·- \ )
.· / " /
Q - I \ !
_ ~.::...--~·. S > S · ·, '> · S <. <.,JS ', S ·· \ " '}
o/
N' -
\
•
Figure 10 of Emilio is a side view of the intramedullary nail according to
Emilio's invention, showing the structure of "inwardly projecting tongue[]
120 ... at the piercing point[] 12." (Emilio 4:28-31, 5:16-19.)
The Examiner points to the piercing point 12 and the inwardly
projecting tongue 120 in Emilio's Figure 10 as, respectively, the "opening
extending laterally through a wall [ of the nail]" and the "ramped surface ...
opposite the opening" recited in claim 1. ( Ans. 2-3.) As Appellants point
out, however, the inwardly projecting tongues in Emilio's intramedullary
7
Appeal2017-003892
Application 13/523,227
nail are formed adjacent to the piercing point rather than "opposite" the
opening as required by claim 1. (Appeal Br. 7; Reply Br. 5-6.)
In responding to Appellants' argument, the Examiner stated that the
tongues do not form the openings themselves, because "it is the wall of the
intramedullary nail which forms the tongues (ramped surfaces) and the
piercing points which form the openings." (Ans. 7.) The Examiner states
that, "[t]herefore[,] Emilio discloses an[] intramedullary nail comprising a
'channel including a ramped surface (120, 130, 140) along a distal portion
thereof opposite the opening (12, 13, 14)." (Ans. 7.)
We are not persuaded. Regardless of whether the piercing points (i.e.,
openings) are formed in part by the inwardly projecting tongues cited by the
Examiner as the "ramped surface" of claim 1, the Examiner has provided no
persuasive explanation, such as a construction of "opposite the opening," as
to how the inwardly projecting tongues may be considered to be "opposite"
the piercing points in Emilio's intramedullary nails.
Accordingly, we reverse the Examiner's rejection of claim 1 as
obvious over Emilio and James. We also reverse the rejections of claims 2
and 5-12, which depend directly or indirectly from claim 1, for the same
reasons. 9 In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988) ("Dependent
claims are nonobvious under section 103 if the independent claims from
which they depend are nonobvious.").
9 As discussed above, claims 2, 5-8, 11, and 12 are also rejected as obvious
over Emilio and James. Claims 9 and 10 are rejected as obvious over
Emilio, James, and Ferrante. The Examiner does not rely on Ferrante to
disclose the limitation relating to "the channel including a ramped surface
along a distal portion thereof opposite the opening."
8
Appeal2017-003892
Application 13/523,227
Independent claim 13, which is rejected over Emilio and Bramlet,
contains the same limitation as claim 1 regarding "the channel including a
ramped surface along a distal portion thereof opposite the opening."
(Appeal Br. 18 (Claims App.).) The Examiner relies on the same teachings
in Emilio discussed above for the disclosure of this limitation (Final Act.
12), and we reverse the rejection of claim 13 for the reasons already
discussed. We likewise reverse the rejection of claims 14--17 and 19, which
depend directly or indirectly from claim 13, for those reasons. 10 In re Fine,
837 F.2d at 1076.
II.
Issue
The Examiner rejects claims 4, 20-22, and 24--26 as obvious over
Emilio, James, and Monfardini.
The Examiner finds that the combination of Emilio and James teaches
all of the limitations of claim 20, except that Emilio and James do not teach
a wire to be inserted into a channel of an intramedullary nail wherein the
distal end of the wire has "a diameter that is larger than a diameter of a
remaining length of the wire to form a natural bend in the wire." (Ans. 4--5.)
The Examiner finds, however, that Monfardini teaches "an intramedullary
nail ... comprising a wire ... wherein the distal end has a diameter that is
larger than a diameter of a remaining length of the wire ... to form a natural
be[n]d in the wire." (Id. at 5---6.)
1° Claims 14, 15, and 19 are also rejected as obvious over Emilio and
Bramlet. Claims 16 and 17 are rejected as obvious over Emilio, Bramlet,
and Maale. The Examiner also does not rely on Maale to disclose the
limitation relating to "the channel including a ramped surface along a distal
portion thereof opposite the opening."
9
Appeal2017-003892
Application 13/523,227
The Examiner concludes that it would have been obvious to a skilled
artisan to modify the wire of Emilio to include a stop, as required by claim
20 and taught by James, for the reason discussed above with respect to claim
1. (Id. at 5.) The Examiner also concludes that it would have been obvious
to a skilled artisan to modify the wire of Emilio so that its diameter is larger
at the distal end than in the remaining length to form a natural bend in the
wire, as taught by Monfardini, so that "the wire may fit inside a channel of
the nail without interfering with an insertion tool ... or other tools, due to
the smaller diameter." (Id. at 6.)
Appellants contend that, while Monfardini discloses "a wire having a
straight portion and an angled portion," it does not disclose a wire with a
distal end "having a diameter that is larger than a diameter of a remaining
length of the wire to form a natural bend in the wire." (Appeal Br. 13; Reply
Br. 10-12.)
As discussed above, claim 4 depends from claim 1, and we reverse the
rejection of claim 4 as obvious over Emilio, James, and Monfardini for the
reasons discussed with respect to claim 1. 11 In re Fine, 83 7 F .2d at 107 6.
The remaining issue with respect to this rejection is whether Monfardini
discloses "a wire ... to be inserted into [a] channel of [an] intramedullary
nail ... , the distal end having a diameter that is larger than a diameter of a
remaining length of the wire to form a natural bend in the wire."
11 The Examiner does not rely on Monfardini to disclose the limitation
relating to relating to "the channel including a ramped surface along a distal
portion thereof opposite the opening."
10
Appeal2017-003892
Application 13/523,227
Analysis
The Examiner cites Figure 4 of Monfardini as disclosing the limitation
of "a wire sized and shaped to be inserted into the channel of the nail ... ,
the distal end having a diameter that is larger than a diameter of a remaining
length of the wire to form a natural bend in the wire," as recited in claim 20.
(See Ans. 5.) To facilitate our discussion, an annotated version of
Monfardini Figure 4 is reproduced below:
Monfardini's Figure 4 shows an intramedullary nail (1) according to its
invention, comprising a tube (2) having a proximal region (3) and a distal
region (4) that are provided with holes (5, 6) for the insertion of pairs of wire
rods (18, 7). (Monfardini ,r,r 17-20.) The annotated version of Figure 4
reproduced above includes added arrows pointing to the portions of Figure 4
relied upon by the Examiner as the "distal end" and "remaining length"
11
Appeal2017-003892
Application 13/523,227
recited in claim 20, wherein "the distal end [has] a diameter that is larger
than a diameter of a remaining length of the wire to form a natural bend in
the wire." (Id. ,r 17; Ans. 6.)
We agree with Appellants that the Examiner has not established a
prima facie case that the cited prior art combination suggests the invention
of claim 20. Assuming for argument's sake that Monfardini's Figure 4
shows wire rods with a distal end having greater thickness than the central
portion when the rods are viewed in longitudinal section, 12 we are not
persuaded that Figure 4 suggests a wire with "distal end having a diameter
that is larger than a diameter of a remaining length of the wire."
12 With respect to the Examiner's reliance on Monfardini's Figure 4,
Appellants argue that, "when the references does not disclose that the
drawings are to scale and is silent as to dimensions, arguments based on
measurement of the drawing features are of little value." (Appeal Br. 13-14
(citing Hockerson-Halberstadt, Inc. v. Avia Group Int'!, 222 F.3d 951, 956
(Fed. Cir. 2000)), see also Reply Br. 11.) The Examiner asserts that
"[ s Jpecific measurements or numeric values or [ratios] are not required by
the claim" in this case and that Monfardini's Figure 4 clearly shows "'a
[ distal end] diameter larger than a diameter of the remaining length of the
wire,"' as required by claim 20. (Ans. 8.) We are not persuaded that the
principle cited in Hockerson-Halberstadt regarding reliance on drawing
features is necessarily inapposite in situations where the claim recites a
relative dimension rather than specific measurements, values, or ratios. The
issue in Hockerson-Halberstadt, for instance, also involved an issue of
relative dimension, namely whether the claim limitation "central
longitudinal groove" required the width of the groove to be less than the
combined width of the fins. Hockerson-Halberstadt, 222 F.3d at 954. We
need not resolve this issue, however, because we find that the Examiner has
not established a prima facie case that claim 20 is obvious for the other
reasons discussed herein.
12
Appeal2017-003892
Application 13/523,227
More specifically, Monfardini teaches that the wire rods used in its
intramedullary nail have tubular portions that blend into a flat central portion
before continuing with another tubular portion that bends, at the distal end of
the wire rod, at an angle with respect to, e.g., the flat central portion of the
rod. (Monfardini ,r,r 21, 25-26.) Because Figure 4 shows only a
longitudinal sectional view of the intramedullary nail, it does not suggest
that the diameter of the tubular distal end (i.e., tubular section near end
points 21 of wire rods 18) is necessarily larger than the "diameter" of the flat
central portion 22, even if Figure 4 shows that the tubular section has a
greater thickness than the flat central portion in one particular view of the
nail.
For instance, Figure 4 also shows a top view of a second pair of wire
rods 7 having a flat central portions 15 and distal end points 20, which
shows the flat central portion 15 to have a slightly larger diameter, in top
view, than the tubular distal section. To the extent the Examiner's position
is that the limitation at issue is met so long as the distal end has a greater
diameter than a remaining length of the wire when viewed from any angle,
the Examiner has not provided evidence that such a construction is
supported by ordinary meaning or the Specification.
We further agree with Appellants that the Examiner has not
established a prima facie case that Monfardini teaches a wire that forms or is
capable of forming a "natural bend."
The Examiner cites paragraphs 16 and 21 and Figures 4 and 5 of
Monfardini as disclosing a natural bend in the wire. (Ans. 5, 8.) Paragraph
16 of Monfardini states that wire rods inserted into the intramedullary nail
are "angled at their distal portion that enters [the] angled holes" laterally
13
Appeal2017-003892
Application 13/523,227
provided in a tube forming the intramedullary nail. (Monfardini ,r 16.) As
discussed above, paragraph 21 states that Monfardini's wire rod 7 (shown in
annotated Figure 4 above), "is constituted by a tubular portion which blends
into a flat central portion 15 and then continues with a tubular portion which
bends at the distal end of the wire rod 7, at an angle with respect to the
overlying portions of the wire rod." (Id. ,r 21; see also id. ,r 26 ( stating that
"wire rods 18 ... have a pointe 21 which is angled with respect to their flat
central portion 22").
Neither these disclosures nor Figures 4 and 5 of Monfardini, however,
suggest that the bend in the wire rods of Monfardini' s intramedullary nail is
a "natural" bend formed by the differing diameters along the length of the
wire, as recited in claim 20, rather than, e.g., intentionally shaped.
( Compare with Spec. ,r 12 ( describing wire having larger diameter at the
distal end such that "a natural inflection point is formed along the wire ... at
the place where the distal end ... meets the remaining length of the wire"
and the distal end bends at the inflection point when it contacts the ramped
portion of the intramedullary nail channel so that it is angled to extend
through an opening into surrounding bone).)
Accordingly, we reverse the Examiner's rejection of claim 20. We
also reverse the rejections of claims 21, 22, and 24--26, which depend from
claim 20, for the same reasons. In re Fine, 837 F.2d at 1076.
SUMMARY
For the reasons above, we reverse the Examiner's decision rejecting
claims 1, 2, 4--17, 19--22, and 24--26.
REVERSED
14