Ex Parte Mantovani et al

Patent Trial and Appeal Board

Jan 28, 2019

13879764 (P.T.A.B. Jan. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/879,764 04/16/2013 Matteo Mantovani
86378 7590 01/30/2019
Pearne & Gordon LLP
1801 East 9th Street
Suite 1200
Cleveland, OH 44114-3108
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.
BUGB-51021 5467
EXAMINER
SCHWIKER, KATHERINE H
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
01/30/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patdocket@pearne.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MATTEO MANTOVANI and
ENRICO RASIA DANI
Appeal2018-002128
Application 13/879, 7 64
Technology Center 3700
Before MICHAEL L. HOELTER, MICHAEL J. FITZPATRICK, and
JILL D. HILL, Administrative Patent Judges.
FITZPATRICK, Administrative Patent Judge.
DECISION ON APPEAL
Matteo Mantovani and Enrico Rasia Dani ("Appellants") 1 appeal
under 35 U.S.C. § 134(a) from the Examiner's final decision rejecting
claims 1 and 3-11. We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
1 The real party in interest is identified as NCS Labs S.R.L. Appeal Br. 1.
Appeal2018-002128
Application 13/879,764
STATEMENT OF THE CASE
The Specification
The claimed invention "relates to a fixing device for suture threads to
be inserted into a bone tissue." Spec. 1: 1-2. More specifically, it relates to
"surgical operations, aimed at treating lesions which require re-setting and
fixing tendons to the respective portions of bone in order to restore the
original footprint or for repairing tendon damage." Id. at 1 :4---6.
Figure 1 is reproduced below.
1 '-----'., Fig. i
Figure 1, reproduced above, shows fixing device 1 before deployment in a
bone. The fixing device includes first portion 11 with eyelet 10 therethrough
and second portion 12 also with eyelet 13 therethrough.
The first portion ( 11) has a wider maximum width than the second
portion, providing a "mushroom shape" and surfaces 15. Id. at 4: 13-17,
6:16-19.
The second portion (12) is "elongate[d]," has a "convex external
configuration," and has "elastic deformability," which features allow it to
couple within the interior walls of a channel within which it inserted, as
shown in Figure 2. Id. at 2:26-27, 3:5-10.
Figure 2 is reproduced below.
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Application 13/879,764
Figure 2, reproduced above, shows the fixing device deployed within
channel 60 that has been drilled or otherwise formed through bone 6. Id. at
3 :24--4: 1. The second portion is fully advanced into the channel such that
surfaces 15 of the mushroom-shaped first portion abut the exterior surface of
the bone. The fixing device is anchored in place by virtue of the elastic
return of the second portion against the interior walls of the channel as well
as the fact that surfaces 15 of the mushroom shape of the first portion rest
against the external surface of the bone. Id. at 3: 10-23. The fixing device
fixes the tendon 40 indirectly and at two separate positions via sutures
extending from both eyelets 10 and 13. Spec. 4:2-8.
The Rejected Claims
All pending claims, namely claims 1 and 3-11, stand rejected. Final
Act. 1. Independent claim 1 is representative and reproduced below.
1. A fixing device for suture threads to be inserted
into a bone structure, comprising
a first portion ( 11, 21) and a second portion ( 12, 22 ), the
device having an undeployed state, a deployed state, and a
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Application 13/879,764
longitudinal dimension, said deployed state being a state when
the device is deployed in a bone structure,
the first portion (11, 21) being provided with a first eyelet
(10, 20) or eye effectively sized to receive a first suture thread
( 4) therethrough, the first eyelet or eye defining an opening
through which the first suture thread passes through in a
direction perpendicular to the longitudinal dimension,
the second portion (12, 22) exhibiting a second eyelet or
eye effectively sized to receive a second suture thread ( 4)
therethrough,
the second portion (12, 22) comprising an engagement
portion which is effectively sized and shaped such that it can
effectively contact and engage an interior surface of a
transosseus seating or hole (5) afforded in the bone structure to
thereby stably couple the device with the bone structure,
the second portion (12, 22) having a neck portion located
between the engagement portion and the first portion, the
engagement portion being spaced apart from the first portion,
the engagement portion having a medial portion and a distal
portion, the medial portion being located between the neck
portion and the distal portion,
the fixing device being configured so that, in use, the
engagement portion is inserted, distal portion first, into the
transosseus seating or hole (5),
the neck portion having a first width transverse to the
longitudinal dimension, the first portion comprising a
mushroom-shaped portion having a second width transverse to
the longitudinal dimension, the second width being larger than
said first width in both the undeployed state and the deployed
state, the second width being larger than said first width when
the first eyelet or eye defines said opening through which the
first suture thread passes through in a direction perpendicular to
the longitudinal dimension,
the mushroom-shaped portion being integral with the
neck portion, the neck portion being integral with the
engagement portion,
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Application 13/879,764
the mushroom-shaped portion extending beyond the neck
portion in a first direction transverse to the longitudinal
dimension in both the undeployed state and the deployed state,
the mushroom-shaped portion extending beyond the neck
portion in a second direction transverse to the longitudinal
dimension in both the undeployed state and the deployed state,
the second direction being opposite to the first direction, and
wherein at least the second portion (12, 22) is elastically
deformable in order to enable effective coupling to the
transosseus seating or hole (5).
Appeal Br. 11 (paragraphing added).
The Appealed Rejections
The following rejections are before us for review:
1. claims 1 and 3-11 under 35 U.S.C. § 112 as failing to comply
with the written description requirement (Final Act. 2); and
2. claims 1 and 3-11 under 35 U.S.C. § 103 over Bojarski, 2
Iannarone, 3 and W est4 (Final Act. 5).
DISCUSSION
Rejection 1
The Examiner rejected all pending claims, namely claims 1 and 3-11,
under 35 U.S.C. § 112 as failing to comply with the written description
requirement. Final Act. 2. More specifically, the Examiner rejected the
claims because the limitation of claim 1 reciting "the first eyelet or eye
defining an opening through which the first suture thread passes through in a
2 US 6,086,591, issued July 11, 2000 ("Bojarski").
3 US 2008/0275554 Al, published Nov. 6, 2008 ("Iannarone").
4 US 5,964,764, issued Oct. 12, 1999 ("West").
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Application 13/879,764
direction perpendicular to the longitudinal dimension" is allegedly not
supported by the application as filed. Id. at 2-3.
"In order to satisfy the written description requirement, the disclosure
as originally filed does not have to provide in haec verba support for the
claimed subject matter at issue." Purdue Pharma L.P. v. Paulding, Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, the disclosure must convey
with reasonable clarity to those skilled in the art that the inventor was in
possession of the invention. See id.
The Examiner states: "The only support for [the perpendicular]
limitation can be found in the drawings and the drawings do not clearly
illustrate the suture passing in a direction perpendicular to the longitudinal
dimension." Id. at 3. It is true that there is no in haec verba or explicit
description, in the application as filed, of a suture passing through an eyelet
in "a direction perpendicular to the longitudinal dimension," as recited in
claim 1. Yet it is also true that the drawings illustrate the eyelet itself being
oriented perpendicular to the longitudinal dimension, as argued by
Appellants and agreed to by Examiner. Spec., Fig. 1 (ref. 10); Appeal Br. 3;
Ans. 17 ("Appellant is illustrating that the first eyelet has a depth that is in a
direction perpendicular to the longitudinal dimension.").
Still, the Examiner asserts that the rejection is justified because, even
though the eyelet is perpendicular, a suture can extend through it at myriad
angles to the longitudinal direction, with only one of those angle being 90
degrees. See, e.g., Ans. 17 ("The eyelet can have a depth direction
perpendicular to the longitudinal axis, but not have the suture passing
through that eyelet in a direction perpendicular to the longitudinal
dimension."). We agree with the Examiner that, given the size of the eyelet
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and suture depicted in Figure 2, for example, a suture could pass through the
eyelet in a non-perpendicular direction.
However, a suture is not a requirement of claim 1, which is directed to
the fixing device alone. We construe the limitation "the first eyelet or eye
defining an opening through which the first suture thread passes through in a
direction perpendicular to the longitudinal dimension" as meaning the first
eyelet/eye is configured to receive a suture thread pass through it in a
direction perpendicular to the longitudinal dimension.
The original drawings clearly illustrate the eyelet having its axis
perpendicular to the longitudinal direction. Spec., Fig. 1. And the
application as filed describes the eyelet as configured to receive a suture.
Spec. 2:16-18. We find that the most apparent direction for a suture to pass
through a hole would be along its axis. In light of this disclosure, we find
that the application as filed conveys to the person of ordinary skill in the art
with reasonable clarity an eyelet that is configured to receive a suture thread
in a direction perpendicular to the longitudinal direction and therefore, as
recited in claim 1, "the first eyelet or eye defining an opening through which
the first suture thread passes through in a direction perpendicular to the
longitudinal dimension."
For the foregoing reasons, the Examiner's rejection of claims 1 and 3-
11 under 35 U.S.C. § 112 is reversed.
Rejection 2
The Examiner rejected claims 1 and 3-11 under 35 U.S.C. § 103 over
Bojarski, Iannarone, and West. Final Act. 5. The Examiner's rejection is
based on combining features from three prior art devices, all having to do
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with fixing injured tendons or other soft tissue to bones. Id. at 5-11. That is
where the similarly with the claimed invention ends.
All three prior art devices differ from the claimed invention in that
they directly attach to the tendon ( or other soft tissue) that they hold in place.
Bojarski, Fig. 7 (ref. 12); Iannarone, Fig. 4 (ref. 199); West, Fig. 4 (ref. 35).
The prior art devices are advanced into their final anchored positions in one
direction until movement in the opposite direction is restricted. In Bojarski
and West, the devices are advanced all the way through a channel until a
transverse structure at the end emerges to deflect transversely with respect to
the channel's axis thereby preventing backward movement. Bojarski, 4:54--
55; West, Fig. 6 (ref. 72). In Iannarone, the device is advanced through a
channel to a desired position therein, at which point the device is pulled back
slightly to deploy spring-loaded claw-like "fixation devices" that grip the
inside of the channel, preventing further rearward movement. Iannarone,
Fig. 3 (ref. 60a and 60b ).
In contrast, the claimed invention is not configured to attach directly
to a tendon ( or soft tissue). It is attached rather to sutures that, in tum, are
attached to a tendon. See Spec. Fig. 2. Thus, the claimed invention does not
work like the prior art to advance a device into a channel with the device
pulling a tendon ( or soft tissue) behind it.
Only an elongated "second portion" of the claimed fixing device is
advanced into a channel in a bone. The mushroom-shaped "first portion"
remains outside, acting as physical stop preventing any further insertion of
the device. Additionally, per claim 1, the second portion comprises "an
engagement portion which is effectively sized and shaped such that it can
effectively contact and engage an interior surface of a transosseus seating or
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hole ( 5) afforded in the bone structure to thereby stably couple the device
with the bone structure." Thus, the claimed fixing device, is configured to
resist movement in either direction within a channel once it is deployed
therein.
The Examiner's rejection starts with the embodiment of Figure 6 of
Bojarski, which is reproduced below. Id. at 5.
FIG. 6
Figure 6 of Bojarski, reproduced above, shows "anchor" 310 having hook
320 and loop 343. Bojarski 4:53-56. The loop 343 is for connecting a
tendon, not a suture, as can be seen in a different embodiment. Id. at Fig. 1.
Sutures 334a and 334b are attached via holes 334 and 334 to pull the anchor
and an attached tendon (not pictured) in the upward direction through a
channel drilled in a bone. Id. at 4:57---63. The hook is flexible and small
enough to allow the anchor to be pulled through a channel (in the upward
direction on this page) of substantially the same width as the body of the
anchor. Id. at 1:60---61, 3:35-37. After the anchor is in place, the hook
prevents the anchor from being drawn back through the channel (in the
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downward direction on this page), thus facilitating anchoring the tendon
with tension. Id. at Fig. 7c.
In brief, the Examiner asserts that it would have been obvious to
incorporate into Bojarski, a second tooth opposite the disclosed one and
form a mushroom shape per West and also to make the asserted second
portion of Bojarski (i.e., the portion of it opposite the end that the hook)
expandable as taught by Iannarone. Id. at 8-11.
In Bojarski, rearward ( downward) movement of the device is
restricted by hook 320 that provides a physical stop for the device. Bojarski,
Fig. 6 (ref. 320); see also id. at Fig. 7c (ref. 420). The Examiner states that it
would have been obvious to incorporate Iannarone's spring-loaded claws
60a and 60b "to improve the fixation of the device to bone by being able to
deform and engage surrounding bone tissue." Final Act. 9. We find the
reasoning offered for incorporating the teachings of Iannarone into Bojarski
insufficient in the absence of any explanation for how the Bojarski device
otherwise would fail to resist backward movement (i.e., Bojarski's single
hook 320 already precludes backward movement).
The reasoning is even more dubious in relation to a device
"configured so that, in use, the engagement portion is inserted, distal portion
first, into the transosseus seating or hole," as required by claim 1. This is so
because incorporating Iannarone's claws 60a and 60b into Bojarski would
prevent the resulting device from being inserted into a bone channel without
destroying or displacing bone tissue in the process.
For the foregoing reasons, the Examiner's rejection of claims 1 and 3-
11 under 35 U.S.C. § 103 is reversed.
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CONCLUSION
For the reasons discussed, we reverse the Examiner's rejections.
REVERSED
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