Ex Parte Bennett

Patent Trial and Appeal Board

Nov 15, 2017

12511462 (P.T.A.B. Nov. 15, 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.
12/511,462 07/29/2009 Steven Bennett H-US-01402 (1603-54) 3833
50855 7590
Covidien LP
60 Middletown Avenue
Mailstop 54, Legal Dept.
North Haven, CT 06473
EXAMINER
DORNBUSCH, DIANNE
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
11/17/2017 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 STEVEN BENNETT1
Appeal 2016-008371
Application 12/511,462
Technology Center 3700
Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
SCHEINER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1—3, 5—21, and 24—26, directed to a medical device for wound
closure. The claims have been rejected on the grounds of anticipation and
obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
Claims 1—3, 5—21, and 24—26 are on appeal. Claim 4 has been
canceled, and claims 22 and 23 have been withdrawn from consideration.
Claims 1 and 11 are independent, are representative, and read as follows:
1 Appellant identifies the Real Party in Interest as Covidien LP. Appeal Br.
1.
Appeal 2016-008371
Application 12/511,462
I. A medical device for wound closure, the medical
device comprising:
an elongate body having a distal portion and a proximal
portion, and a plurality of barbs extending from a surface
thereof;
a foam structure attached to the distal portion of the
elongate body such that the foam structure is disposed at a
distal-most end of the medical device;
an inner member moveably positioned on the elongate
body proximal of the foam structure and configured to engage a
first portion of tissue; and
an outer member moveably positioned on the elongate
body proximal of the inner member, the inner member having a
smaller diameter than the outer member and being positioned
between a portion of the outer member and the distal portion of
the elongate body, the outer member configured to engage a
second portion of tissue located radially outward of the inner
member and radially adjacent the first portion of tissue when
the inner member engages the first portion of tissue.
II. A medical device for wound closure, the medical
device comprising:
an elongate body having a distal portion and a proximal
portion, and a plurality of barbs extending from a surface
thereof;
a foam structure attached to the distal portion of the
elongate body such that the foam structure is disposed at a
distal-most end of the medical device; and
a substantially rigid frusto-conical outer member
moveably positioned on the elongate body, such that a narrow
portion of the outer member is oriented toward the distal
portion of the elongate body.
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Application 12/511,462
The claims stand rejected as follows:
Claims 1—3, 5, 6, 8—10, and 25 under 35 U.S.C. § 102(b) as
anticipated by Nash2 (Ans. 3 4);
Claims 7 and 24 under 35 U.S.C. § 103(a) as unpatentable over Nash
and Egnelov3 (Ans. 4—5);
Claims 11—15 and 26 under 35 U.S.C. § 103(a) as unpatentable over
Evans4 and Chin5 (Ans. 5—6); and
Claims 16—21 under 35 U.S.C. § 103(a) as unpatentable over Evans,
Chin, and Egnelov (Ans. 6—7).
ANTICIPATION
The Examiner finds that claims 1—3, 5, 6, 8—10, and 25 are anticipated
by Nash. Final Action 2-4; Ans. 2-4.
To anticipate “it is not enough that the prior art reference discloses
part of the claimed invention, which an ordinary artisan might supplement to
make the whole, or that it includes multiple, distinct teachings that the
artisan might somehow combine to achieve the claimed invention.” Net
MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).
“Every element of the claimed invention must be literally present, arranged
as in the claim.” Richardson v. Suzuki Motor Co., Ltd., 868 F.2d 1226, 1236
(Fed. Cir. 1989).
2 U.S. Patent No. 5,700,277, issued December 23, 1997.
3 U.S. Patent Application Publication No. 2006/0142797 Al, published June
29, 2006.
4 U.S. Patent No. 5,549,633, issued August 27, 1996.
5 U.S. Patent Application Publication No. 2007/0049971 Al, published
March 1, 2007.
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Application 12/511,462
Nash
Nash discloses a “hemostatic closure[] for sealing percutaneous
incisions or punctures in blood vessels or other body vessels, ducts, or
lumens.” Nash 1:8—10. The closure device includes a suture-like filament;
an anchoring member in the shape of a strip or bar; a disk- or washer-like
locking member; and a cylindrical sealing member formed of compressible
collagen foam. Id. at 5:27—29, 50—51, 6:34—35.
Figure 6 of Nash is reproduced below:
Figure 6, reproduced above, depicts an embodiment of Nash’s closure
device showing locking member 36 interposed between plug or sealing
member 30 and anchor member 32. Apertures in plug 30 “serve as
passageways through which the positioning filament 34 extends to connect
the anchor member 32 to the plug 30.” Id. at 5:47-49. Both the portion of
filament 34 from the plug member to the anchor member and the portion of
the filament from the anchor member back to the plug member extend
through a central opening in the locking member 36. Id. at 8:56—64.
Nash explains that:
The anchoring means is arranged to be brought into
engagement with the interior tissue of the vessel contiguous with
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Application 12/511,462
the opening in the vessel and with the sealing means being
located within the puncture tract remote from the vessel. The
filament means is connected between the anchoring means and
the sealing means so that the sealing means may be moved in the
tract toward the anchoring means to a puncture sealing position
by the application of a pulling force on the filament means. The
anchoring means is in engagement with the interior tissue of the
vessel contiguous with the opening therein when the sealing
means is in the puncture sealing position.
The locking means is actuatable to cooperate with the
filament means to hold the anchoring means and the sealing
means in the puncture sealing position.
Id. at 3:26-41.
In other words, Nash’s device is configured so that the plug or sealing
means slides along the filament toward the anchoring means when the
anchoring means is positioned in the vessel and the filament is pulled.
Discussion
The Examiner finds that Nash discloses a medical device for wound
closure comprising:
[A]n elongate body (34) having a distal portion and a proximal
portion (Fig. 1—9 and 19), and a plurality of barbs (102)
extending from a surface thereof (Fig. 19); a foam structure (30)
attached to the distal portion of the elongated body (Fig. 6 and
19) such that the foam structure is disposed at a distal-most end
of the medical device . . . ; an inner member (36a, b, c, c’, 78)
moveably positioned on the elongate body proximal of the foam
structure and configured to engage a first portion of tissue (Fig.
1—9 and 19); and an outer member (32) moveably positioned on
the elongate body proximal of the inner member (Fig. 1—9 and
19), the inner member having a smaller diameter than the outer
member (Fig. 1—9 and 19) and being positioned between a
portion of the outer member and the distal portion of the elongate
body (Fig. 1—9 and 19).
Final Action 2—3.
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Application 12/511,462
The Examiner contends that Appellant “did not properly define which
side is the distal and which one is the proximal therefore the examiner is
interpreting it as the proximal end being where component 32 is and the
distal end being where component 30 is as seen in [Nash’s] Fig. 6 and 19.”
Id. at 10.
Appellant contends that “the ‘distal portion’ and the ‘distal most end’
identified by the Examiner . . . results only from an arbitrary delineation of
the components of the closure device of Nash in order to meet the features of
claim 1.” Reply Br. 5. Appellant further contends that “[t]he Examiner’s
interpretation is unreasonable at least because it ignores the positioning
filament 34’ extending beyond the portion of the closure device that is
characterized by the Examiner as the ‘distal most end.’” Id. Appellant
contends, therefore, that “Nash has not been shown to have disclosed a
medical device including inter alia, ‘a foam structure attached to [a] distal
portion of [an] elongate body such that the foam structure is disposed at a
distal-most end of the medical device,’ as recited in claim 1.” Appeal Br. 5
(emphasis omitted).
Analysis
The evidence of record supports the Examiner’s findings that Nash’s
wound closure device comprises an elongate body (Nash’s “filament” 34); a
foam structure (Nash’s “sealing member” or “plug” 30, made of
compressible, resorbable collagen foam); an inner member (Nash’s “locking
member” 36); and an outer member (Nash’s “anchor member” 32), the inner
member having a smaller diameter than the outer member.
In addition, we agree with the Examiner that “proximal” and “distal”
are defined with respect to an arbitrary reference point, and it is of no
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Application 12/511,462
moment that Nash defines them in an ostensibly reverse orientation—so
long as the foam structure, the inner member, and the outer member of
Nash’s device are oriented along the elongate body in the same sequence
required by claim 1, relative to each other. That is, the inner member must
be between the foam structure and the outer member.
Nevertheless, we find that Nash does not anticipate claim 1 at least
because the various elements of Nash’s device are not arranged as in the
claim and do not operate as required by the claim. Claim 1 recites that the
foam structure is “attached” to the elongate body “such that the foam
structure is disposed at a distal-most end of the medical device,” while the
inner member and outer member are “moveably positioned” on the elongate
body. That the terms “attached” and “moveably positioned” have different
meanings can be inferred from their inclusion in the same claim. See
Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 93 F.3d 1572, 1579 (Fed.
Cir. 1996) (“If the terms ‘pusher assembly’ and ‘pusher bar’ described a
single element, one would expect the claim to consistently refer to this
element as either a ‘pusher bar’ or a ‘pusher assembly,’ but not both,
especially not within the same clause.”).
Moreover, the two terms are used differently in the Specification. For
example, the Specification discloses “a foam structure attached to the distal
portion of the elongate body” (Spec. 110), and teaches that the foam
structure may be connected to the elongate body “using various methods . . .
including, but not limited to, molding, over molding, adhesives and glues
(e.g., cyanoacrylates), mechanical connections, male and female locking
mechanisms, and the like” {id. 123). Thus, one of ordinary skill in the art
would understand from the way the term “attached” is used in the
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Application 12/511,462
Specification that the foam structure is stationary with respect to the
elongate body. On the other hand, the Specification discloses “an inner
member and outer member, each moveably positioned along the elongate
body” (id. 1 6), and able to “move distally along the elongate body” toward
the foam structure (id. 19).
Thus, the Examiner has established that Nash’s inner member
(locking member 36) is situated between the foam structure (plug 30) and
the outer member (anchor member 32), as required by claim 1. The
Examiner has also established that Nash’s inner member is moveably
positioned on the elongate body (Nash’s filament 24). However, the
Examiner has not shown that Nash’s foam structure is “attached” to the
elongate body in the manner required by the claim. Nor has the Examiner
shown that the foam structure is disposed at either end of the elongate
body—whether distal or proximal. Nor, for that matter, has the Examiner
established that Nash’s outer member is moveably positioned on the
elongate body, as also required by claim 1.
Conclusion
The evidence of record does not support the Examiner’s finding that
Nash meets all the limitations of claim 1, or claims 2, 3, 5, 6, 8—10, and 25
which depend from claim 1. Accordingly, the rejection of claims 1—3, 5, 6,
8—10, and 25 as anticipated by Nash is reversed.
OBVIOUSNESS
Nash and Egnelov—Claims 7 and 24
Claims 7 and 24, which depend from claim 1, stand rejected as
unpatentable over Nash and Egnelov. These claims recite “wherein the
[inner/outer] member is a tissue a scaffold.”
8
Appeal 2016-008371
Application 12/511,462
Egnelov discloses a medical sealing device wherein inner and outer
sealing members comprise scaffolding materials. Egnelov H 8, 21.
Nevertheless, as discussed above, the evidence of record does not
support the Examiner’s finding that Nash meets all the limitations of
independent claim 1, and Egnelov does not remedy the underlying
deficiencies of Nash.
Accordingly, we reverse this rejection as well.
Obviousness over Evans and Chin—Claims 11—15 and 26
Claims 11—15 and 26 stand rejected as unpatentable over Evans and
Chin.
A rejection on the ground of obviousness must include “articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). “[Tjhis
analysis should be made explicit” and it “can be important to identify a
reason that would have prompted a person of ordinary skill in the relevant
field to combine the elements in the way the claimed new invention does.”
KSRInt’l Co., v. Teleflex Inc., 550 U.S. 398, 418-19 (2007).
Evans
Evans discloses an apparatus for “reduc[ing] the seepage of blood
from a blood vessel, e.g., an artery, having a puncture which has been sealed
by ... a suture or filament extending through the puncture tract.” Evans
1:64—2:3. The apparatus comprises:
[A] mass of material, e.g., collagen, which inhibits the flow of
the fluid, e.g., blood, therethrough, positioning means for
disposing the mass of material adjacent the puncture, carrier
means for carrying the one extending suture portion into and
through the mass of material, and means for holding the mass of
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Appeal 2016-008371
Application 12/511,462
material with respect to the one extending suture portion so that
the mass of material closely engages tissue contiguous with the
puncture tract to thereby reduce the seepage of the fluid, e.g.,
blood, from the puncture.
Id. at 2:25-34.
Figure 7 of Evans, showing an initial step in the use of the apparatus,
is reproduced below:
Figure 7 is a side elevational view of Evans’ apparatus “showing an initial
step in its use to reduce or prevent blood seepage from a percutaneous
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Appeal 2016-008371
Application 12/511,462
arterial puncture which has been closed by at least one suture.” Evans 3:41—
44. As illustrated in Figure 7, at this step in the process, the marginal edges
of opening 10B in the arterial wall 10C have been sutured closed by means
of plural sutures, only one of which, 24, can be seen. Each suture 24
includes a looped portion 24C extending through the arterial wall and a pair
of extending portions 24A and 24B which are knotted together at 24D
immediately adjacent the exterior surface of the artery wall 10C and which
extend from there through the puncture tract 10A to beyond the surface of
the skin 12. The apparatus is held by the user so that the loop 42 of the
carrier filament 30 is adjacent the puncture tract, whereupon the extending
portions 24A and 24B of the closure 24 are extended or passed through the
interior of the loop 42. Once the extending portions 24 A and 24B of the
suture are passed through the carrier filament loop 42, the proximally
extending portions 44A and 44B of carrier filament are pulled in the
proximal direction. This action pulls the extending suture portions 24B and
24C through a passageway in collagen mass 22, and through the interior of
the tamper 28 until the extending portions of the original suture 24 are
located proximally of the flanged end 38 of the apparatus (as shown in
Figure 8, reproduced below). Id. at 7:30-57.
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Appeal 2016-008371
Application 12/511,462
Figure 8 of Evans is reproduced below:
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Figure of Evans is a side elevational view showing the apparatus “ready to
deploy the mass 22” in the puncture tract 10A. Evans 7:58.
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Application 12/511,462
Figure 15 of Evans is reproduced below:
Figure 15, reproduced above, depicts mass 22 deployed in puncture tract
10A, in position against suture knot 24D and distal suture loop 24C in
arterial puncture 10B. Suture portions 24A and 24B extend through a
central passageway in mass 22 and through openings 52A and 52B in
washer or disc 50. Mass 22 “is held in place by means of the frictional
engagement between it and the suture portions extending through it as well
as the frictional engagement between it and the washer’s openings 52A and
52B and by the location of the knot 24E on the proximal side of the washer
50.” Evans 8:65—9:3.
Chin
Chin discloses an apparatus for temporarily or permanently reducing
the volume or closing off a portion of a ventricle of the heart. Chin | 6. The
apparatus “takes the form of an anchor . . . including an elongated body, a
plurality of protrusions extending from the body, and first and second
mechanical stops or sealing members attachable to the body.” Id. 17.
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Application 12/511,462
Figure 3B of Chin is reproduced below:
120
J
Figure 3B, reproduced above, depicts Chin’s apparatus deployed in the right
and left ventricles of the heart, showing curved needle 122, which forms the
distal tip of anchor 120, a plurality of barbs or protrusions 128 extending
from the surface of the anchor body, proximal stop 124, and distal sealing
stop 126. Chin 129.
Chin explains that:
The curved needle 122 is inserted through the anterior wall and
into the right ventricle, through the septum, and through the
anterior wall of the left ventricle. The body of the anchor follows
the curved needle 122 and is fed through until the proximal stop
124 engages the anterior surface of the right ventricle. The
anterior wall of the left ventricle is pressed inward over the body
of the anchor. A distal sealing stop 126 is threaded over the
anchor 120 and slid in place against the anterior surface of the
right ventricle.... A plurality of barbs or protrusions 128 extend
from the surface of the anchor body. The barbs 128 help hold the
heart tissue in place.
Id.
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Application 12/511,462
Discussion
The Examiner finds that Evans discloses all the limitations of claim
11, except that “Evans fails to teach that the outer member is frusto-conical
or the use of barbs on the outer member.” Final Action 6. However, the
Examiner finds that Chin discloses “a substantially rigid frusto-conical outer
member (126) moveably positioned on the elongate body” {id. at 7), as well
as a “plurality of barbs . . . oriented so as to enable the outer member to
move distally along the elongate body while limiting proximal movement of
the outer member” (id. ).
The Examiner concludes that it would have been obvious for one of
ordinary skill in the art “to modify the shape of the outer member to be
frusto-conical since it has been held that changing the shape of a working
part involves only routine skill in the art.” Id. at 7. The Examiner further
concludes that it would have been obvious “to use barbs on the device of
Evans as taught by Chin in order to make ... a knotless configuration
preventing unwanted movement of the implant once deployed since it would
hold the device in place once deployed.” Id.
Analysis
We are not persuaded that the Examiner’s initial burden of
establishing a prima facie case of obviousness has been met. In particular,
we are not persuaded that the Examiner has adequately explained why one
of ordinary skill in the art would have substituted Chin’s barbed anchor for
Evans’ suture, or even included barbs on Evans’ suture. As Evans explains,
in order to deploy the mass 22 and washer 50 shown in Figure 15 of Evans,
the extending portions of suture 24 (24A and 24B) must be passed through a
carrier loop 42, captured by the loop, and pulled through the passageway 40
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Application 12/511,462
of mass 22, and subsequently through the interior of tamper 28 (See Figure 8
of Evans), until the extending portions 24A and 24B are located proximally
of the flared end of the housing 38 as shown in Figure 8. Only then can
mass 22 be placed in the puncture tract by sliding it along the suture toward
the puncture until it reaches knot 24D. See Evans 7:30-8:20; Figs. 7, 8, 15.
The Examiner has not adequately explained why one of ordinary skill in the
art would have placed barbs on the suture 24 when it must be drawn up
through mass 22 and into the tamper without interference, which would be
impeded by the unidirectional shape of the barbed anchors disclosed in Chin.
Conclusion
The evidence of record does not support the Examiner’s conclusion
that all the limitations of claim 11, or claims 12—15 and 26, which depend
from claim 11, would have been obvious over the combined disclosures of
Evans and Chin. Accordingly, the rejection of claims 11—15 and 26 as
obvious over Evans and Chin is reversed.
Obviousness over Evans, Chin, and Egnelov—Claims 16—21
Claims 16—21, which depend from independent claim 11, stand
rejected as unpatentable over Evans, Chin, and Egnelov. These claims recite
that the frusto-conical outer member of claim 11 is tissue a scaffold.
Egnelov discloses a medical sealing device wherein an outer sealing
member comprises scaffolding materials. Egnelov H 8, 21.
Nevertheless, as discussed above, the evidence of record does not
support the Examiner’s conclusion that the subject matter of claim 11 would
have been obvious the combined disclosures of Evans and Chin, and
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Application 12/511,462
Egnelov does not remedy the underlying deficiencies of the combination of
Evans and Chin. Accordingly, we reverse this rejection.
SUMMARY
The rejection of claims 1—3, 5, 6, 8—10, and 25 under 35 U.S.C.
§ 102(b) as anticipated by Nash is reversed;
the rejection of claims 7 and 24 under 35 U.S.C. § 103(a) as
unpatentable over Nash and Egnelov is reversed;
the rejection of claims 11—15 and 26 under 35 U.S.C. § 103(a) as
unpatentable over Evans and Chin is reversed; and
the rejection of claims 16—21 under 35 U.S.C. § 103(a) as
unpatentable over Evans, Chin, and Egnelov is reversed.
REVERSED
17