Ex Parte Levin et al

Patent Trial and Appeal Board

Sep 21, 2017

12831570 (P.T.A.B. Sep. 21, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/831,570 07/07/2010 Ofek Levin H-US-03200 (203-8451) 2696
50855 7590
Covidien LP
60 Middletown Avenue
Mailstop 54, Legal Dept.
North Haven, CT 06473
09/25/2017 EXAMINER
SCHERBEL, TODD J
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/25/2017 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):
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
mail @ cdfslaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte OFEK LEVIN and ARIE LEVY
Appeal 2016-007930
Application 12/831,57c1
Technology Center 3700
Before ERIC B. GRIMES, DEVON ZASTROW NEWMAN, and
DAVID COTTA, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to an apparatus
and system for use in surgery. The Examiner entered final rejections for
anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify the Real Party in Interest as Covidien LP, the ultimate
parent of which is Medtronic pic. Br. 1.
Appeal 2016-007930
Application 12/831,570
STATEMENT OF THE CASE
Background
A hernia is a protrusion of a tissue, structure, or part of an organ
through the muscular tissue or the membrane by which it is
normally contained. In other words a hernia is a defect in the
abdominal wall through which a portion of the intra-abdominal
contents can protrude. This often causes discomfort and an
unsightly, visible bulge in the abdomen. When such a hernia
defect occurs in the abdominal region, conventional corrective
surgery has required opening the abdominal cavity by surgical
incision through the major abdominal muscles.
Spec. 1.
The Specification discloses an “apparatus [and system] for performing
corrective surgery on internal wounds such as hernia where invasion of the
patient’s body tissues is minimized and resultant trauma is reduced.” Id.
The Claims
Claims 1—4, 6—8, 11—17, 19-23, 38, 40, and 41 are rejected and on
appeal. Final Act. I.2
Claim 1 is illustrative and reads as follows:
1. A clip comprising:
a first portion fixedly attached to an arm of a surgical
instrument that deploys a surgical implant inside a patient’s
body, the surgical instrument includes an elongate shaft,
wherein the arm and the elongate shaft are parallel in a
deployed position and an undeployed position; and
a second portion adapted to releasably receive the
surgical implant, wherein the second portion has a first
configuration relative to the arm of the surgical instrument that
retains the surgical implant and a second configuration relative
to the arm of the surgical instrument that releases the surgical
2 Examiner’s Final Action, mailed Aug. 10, 2015.
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Application 12/831,570
implant, the second portion being parallel to the arm of the
surgical instrument when in the first configuration and a
longitudinal axis of the second portion intersects the arm of the
surgical instrument when the second portion is in the second
configuration,
wherein the clip deforms from the first configuration to
the second configuration to release the surgical implant.
Br. 16 (Claims Appendix) (emphasis added).
The Issues
The following rejections are before us to review:
Claims 1—4, 6, 7, 11—17, 19-21, 23, 38, 40, and 41 are rejected
under pre-AIA 35 U.S.C. § 102(b) as anticipated by DeMatteis.3 Ans.
2.
Claim 8 is rejected under 35 U.S.C. § 103(a) as unpatentable
over DeMatteis in view of Sholev.4 Id.
Claim 22 is rejected under 35 U.S.C. § 103(a) as unpatentable
over DeMatteis in view of Henderson.5 Id.
I
The Examiner finds that DeMatteis discloses all of the limitations of
claim 1. Final Act. 4—8. Specifically with regard to the issues on appeal, the
Examiner finds:
DeMatteis discloses a clip (hook 18) including a first portion
(portion of hook 18 connected to element 16) and a second
portion (portion of hook 18 capturing mesh [21]). The first
portion is fixedly attached to an arm (element 16 and/or inner
member 10) of a surgical instrument that deploys a surgical
3 US 5,383,477, issued January 24, 1995 (“DeMatteis”).
4 US 2010/0292718 Al, published November 18, 2010 (“Sholev”).
5 US 2008/0188874 Al, published August 7, 2008 (“Henderson”).
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Application 12/831,570
implant inside a patient’s body (FIG. 1-11 and col. 2, Ins. 17-23
and 56-68)(e.g., portion of hook connected to element 16 is
fixedly attached to arm 10/16 since it is directly attached to
element 16 and is fixedly attached to inner member 10 through
its connection to element 16).
Final Act. 5.
The Examiner further finds that
the arm (10/16) and the elongate shaft (2) are parallel in a
deployed position[] (FIG. 4) and an undeployed position (FIG.
l)(e.g., at least a portion of the arm 10/16 and shaft 2 are
parallel in these positions since inner member 10 and cylinder 2
are parallel in these positions).
Id.
Issue
The issue in this case is whether a preponderance of the evidence of
record supports the Examiner’s finding that DeMatteis discloses the claimed
subject matter. We select claim 1 as representative of the claims subject to
this ground of rejection. 37 C.F.R. § 41.37(c)(l)(iv).
Analysis
Appellants argue, among other points, that “DeMatteis fails to
disclose a clip having a first portion fixedly attached to an arm of a surgical
instrument and including an elongate shaft ‘wherein the arm and the
elongate shaft are parallel in a deployed position and an undeployed
position’ as recited in independent claim 1.” Br. 4. Rather, Appellants
argue, “DeMatteis clearly discloses that in the extended position, the hooks
18, which are fixedly attached to the elements 16, are at acute angles A and
A’ with respect to the central axis.” Id. at 9. Appellants argue that
DeMatteis “discloses that the elements 16 are connected to one end 14 of the
inner member 10 and are not connected to outer cylinder 2.” Id. at 13.
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Application 12/831,570
Appellants further argue that because the clip is attached to the arm, the clip
must also be parallel to the elongate shaft in both the deployed and
undeployed positions. Id. Appellants argue Figure 4 of DeMatteis makes
clear that the hooks (18) which are fixedly attached to the arm (element 16)
“are at acute angles A and A’ when the applicator 1 is in the deployed
position.” Id. Therefore, Appellants argue, “[t]he elements 16 and the
hooks 18 are only parallel in the first or retracted position” and do not meet
the limitation of claim 1. Id. at 8.
The Examiner responds that
DeMatteis discloses the [parallel position limitation] under at
least one of two interpretations of the recited “arm” of [claim
1]. First, DeMatteis discloses an arm in the form of inner
member 10. Second, DeMatteis discloses an arm in the form of
the combination of inner member 10 and element 16. The
[EJxaminer notes that inner member 10 and element 16 are
hingedly connected as shown in FIG[S]. 2 and 4 of DeMatteis
and that the combination of hinged elements can reasonably be
considered an “arm” just as the combination of hinged bones
(e.g., humerus, radius, and ulna) form a human arm.
Ans. 3.
The Examiner finds that where the inner member 10 is the “arm,” “the
arm (inner member 10) and elongate shaft (outer member 2) are parallel in a
deployed position of FIG. 4 and an undeployed position of FIG. 2” and
“movement of the arm (inner member 10) relative to the elongate shaft
(outer member 2) is parallel movement since the inner member 10
longitudinally reciprocates within the lumen of outer member 2 in FIG. 2
and 4 and col. 4, Ins. 51-67.” Id. The Examiner finds that “the claims do
not recite limitations about the clips being ‘located on’ the arm” but rather
that they be “fixedly attached or coupled to the arm . . . the clip 18 is
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Application 12/831,570
‘fixedly attached’ to the arm (inner member 10) through its connection to the
element 16... since it is securely fastened to the inner member as the inner
member 10 is securely fastened to element 16 and the clip is formed on the
element.” Id. at 4.
The Examiner finds that where the combination of inner member 10
and element 16 is considered the “arm,” “the inner member 10 and element
16 are parallel to the outer member 2 in the undeployed position of FIG. 2 . .
. the inner member 10 is parallel to the outer member 2 in the deployed
position of FIG. 4.” Id. at 5. The Examiner finds “[i]t is irrelevant that
element 16 is not parallel to the outer member 2 in FIG. 4 since the claim
does not recite anything about an entirety of the arm being in this parallel
position” but that a “portion of the arm, such as the inner member 10” being
parallel is sufficient to meet “the claimed limitation.” Id.
The Examiner further finds that
movement of the arm (combination of inner member 10 and
element 16) relative to the elongate shaft (outer member 2) is
parallel movement [because] inner member 10 longitudinally
reciprocates within the lumen of outer member 2 in FIG. 2 and
4 and col. 4, Ins. 51-67 [and] a portion of the arm [is] moving in
this parallel manner.
Id. at 6. The Examiner finds that “element 16 is moved . . . from the
position of FIG. 2 to an axially advanced position” as it exits cylinder 2 and
that this parallel movement meets the limitation. Id. The Examiner
acknowledges that element 16 pivots relative to the outer
member 2 after being axially advanced within its lumen at col.
4, Ins. 60-67. However, this pivotal movement is unpersuasive
since both the inner member 10 and element 16 move parallel
to the outer member 2 within its lumen such that the claimed
limitation is met by the combination arm of inner member 10
and element 16.
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Application 12/831,570
Id.
The Examiner further responds that the claims do not require “the clip
to be parallel to the elongate shaft in the undeployed and deployed positions
or parallel to the shaft as the arm moves relative to the shaft.” Id. at 7.
We agree with Appellants that the Examiner has not shown that
DeMatteis discloses the invention of claim 1.
We begin with claim interpretation. The dispute centers on the
construction of the term “fixedly attached.”
The Specification does not define “fixedly attached.” However, the
Specification consistently uses “attached” to refer to structures that are
directly coupled to one another. For instance, the Specification discloses:
It is another object of the present invention to provide a
detachment mechanism adapted to detach a patch from a patch
deployment device (PDD), wherein said mechanism comprising
at least one crescent shaped connection clip (CC); each of
which comprises:
a. an elastic crescent shaped body 222 coupled to the
distal portion said PDD;
b. at least one protruding portion 201 coupled to said
body, adapted to protrude out of said PDD; said protruding
portion 201 comprising at least one sharp end adapted to be
penetrate said patch;
said distal portion of said PDD is characterized by at
least two configurations: (i) an attached configuration in which
said distal portion is un-deformed such that said protruding
portion 201 penetrates said patch and positioned substantially
parallel to said patch and an attachment between said PDD and
said patch is provided; and (ii) a detached configuration in
which said distal portion is deformed such that said protruding
portion 201 emerges out of said patch and said detachment
between said PDD and said patch is provided.
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Spec. 5 (emphasis added). Accordingly, we find “fixedly attached” means
directly coupled to, including by penetration of the attached element.
Claim 1 requires that “the arm and the elongate shaft are parallel in a
deployed position and an undeployed position.”
DeMatteis discloses:
Mounted within that outer cylinder 2 is an inner member 10
extending generally coaxially with cylinder 2 and having a first
axial end 12 and an opposed, second axial end 14. This inner
member 10 is mounted for movement within said outer cylinder
2 generally parallel to said central axis 4 and supported for such
movement by guide element 15. Proximal [to] the first end 12
of said inner member 10 is attached at least one element 16, and
preferably a plurality of such elements 16. On each of these
elements 16 are provided means, such as hooks 18, for
releasably attaching a section of surgical mesh 21.
DeMatteis 3:60-4:3 (emphasis added).
Figure 6 of DeMatteis is reproduced below:
Figure 6 of DeMatteis “is a fragmentary perspective view, at substantially
larger scale, of a mesh carrying rib of the apparatus of FIG. 1.” Id. at 3:21—
23.
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In light of these disclosures, we are persuaded by Appellants’
argument (Br. 9) that DeMatteis discloses that the hooks are attached to
element 16. Because the “clip” of claim 1 is “fixedly attached to an arm of a
surgical instrument,” we further agree with Appellants that element 16, to
which the clips are coupled, is the only element that could be the “arm.” For
this reason, we are not persuaded that the inner member 10 alone is the arm
and find that the Examiner’s findings in this regard are not supported by the
evidence. We are further unpersuaded by the Examiner’s findings that inner
member 10 can be part of the “arm” because the clip is “fixedly attached” to
the arm by way of its connection to element 16. As discussed above, the
Specification discloses that “fixedly attached” requires direct coupling.
DeMatteis discloses Figures 1 and 4, reproduced below:
Figure 1 is a “perspective view, partially in section, of the hernia
repair apparatus of the present invention in its extended
configuration.” Id. at 3:6—8. Figure 4 of DeMatteis “is a side
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Application 12/831,570
sectional view of the inner end of the apparatus of FIG. 1, with the
mesh supporting elements shown in their extended position.” Id. at
3:15-17.
DeMatteis discloses that in the extended position “the elements
16 then extend at angles A and A’ with respect to the central axis,
generally as illustrated in FIGS. 1 and 4. In this preferred
embodiment the angles A and A’ are preferably in the range of about
30 degrees to 60 degrees.” Id. at 4:67—5:3.
We agree with the Examiner that element 2, as shown in Figures 1 and
4, represents the “elongate shaft” of DeMatteis and further agree that the arm
16 and the elongate shaft 2 are parallel in the undeployed position (see
Figure 2 of DeMatteis). However, we are persuaded by Appellants that the
arm 16 and the elongate shaft 2 are not parallel in the deployed position.
Because the arm, in the deployed position, is rotated to create the A and A’
angles (see Figure 4 of DeMatteis), the arm is not parallel to elongate shaft
2. Because we do not agree with the Examiner that any part of element 10
comprises the arm, we are not persuaded that any movement of element 10
in a parallel fashion to the elongate shaft is sufficient to meet the “arm and
the elongate shaft are parallel in a deployed position and an undeployed
position” limitation. We reverse the rejection.
II
This rejection relies upon the underlying anticipation rejection over
DeMatteis. Having reversed the DeMatteis rejection for the reasons given
above, we necessarily reverse the obviousness rejection further including
Sholev, because the Examiner does not rely upon Sholev to address the “arm
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and the elongate shaft are parallel in a deployed position and an undeployed
position” limitation.
Ill
This rejection relies upon the underlying anticipation rejection over
DeMatteis. Having reversed the DeMatteis rejection for the reasons given
above, we necessarily reverse the obviousness rejection further including
Henderson, because the Examiner does not rely upon Henderson to address
the “arm and the elongate shaft are parallel in a deployed position and an
undeployed position” limitation.
SUMMARY
We reverse all rejections on appeal.
REVERSED
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