Ex Parte Simpson

Patent Trial and Appeal Board

Mar 16, 2018

12519717 (P.T.A.B. Mar. 16, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/519,717 06/17/2009
79990 7590 03/20/2018
C. R. Bard, Inc.
Bard Peripheral Vascular, Inc.
1415 W. 3rd Street
P.O. Box 1740
Tempe, AZ 85280-1740
FIRST NAMED INVENTOR
Charles L. Simpson
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.
289-PDD-06-48US
(99395.8)
CONFIRMATION NO.
5398
EXAMINER
BACHMAN, LINDSEY MICHELE
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
03/20/2018 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):
BPVIP.Docket@crbard.com
Charles.Runyan@crbard.com
raust@austiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHARLES L. SIMPSON
Appeal2017-002908
Application 12/519,717 1
Technology Center 3700
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to blood
clot filters which have been rejected as anticipated, as obvious, and for
failure to comply with the written description requirement. We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
1 Appellant identifies the Real Party in Interest as C.R. Bard, Inc. Appeal
Br. 3.
Appeal2017-002908
Application 12/519, 717
STATEMENT OF THE CASE
Inferior vena cava filters are medical devices which are used to
prevent pulmonary emboli. Spec. i-f 3. The filters trap emboli while still
allowing the flow of blood. Id. The filters may be permanent or retrievable.
Spec. i-f 5. In the case of retrievable filters, the filters must be self-orienting
and able to hold their position in a manner that does not cause undue damage
to the vessel wall. Spec. i-f 18. The Specification describes a filter which
exerts sufficient force against the wall of the blood vessel to hold the filter in
place, yet allows it to be easily removed. Spec. i-f 19.
Claims 1-7, 10-20 and 43 are on appeal. Claims 1, 11, and 19 are the
independent claims and read as follows:
1. A blood clot filter having a filter longitudinal axis, a
filter proximal end and a filter distal end, comprising:
a) a first set of members, each having a first length, and a
second set of members, each having a second length, said
members defining a trap having a proximal trap end and a
distal trap end, said trap sized to fit into a blood vessel having a
vessel wall and wherein said trap is configured to hold an
embolus;
b) each member having a member proximal end and a
member distal end;
c) wherein at least one member of the first set of
members includes a first surface for engaging the vessel wall
such that at least one member of the first set of members resists
downstream movement within the vessel, wherein further at
least one member of the second set of members includes a
second surface for engaging the vessel wall such that the at
least one second member resists upstream movement within the
vessel;
d) wherein at least one of said second surfaces includes a
plurality of at least three spaced apart protrusions next to the
member distal end, and with recesses in between said
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Application 12/519, 717
protrusions, each protrusion having a convexly curved outer
portion that is positioned to engage the vessel wall;
e) a curved connecting portion that connects each
protrusion to another protrusion, each said connecting portion
being spaced inwardly of said outer portions in relation to the
longitudinal axis of the filter wherein both the protrusions and
recesses are located distally and not proximally;
t) said protrusions including a most distal protrusion that
is the farthest of the protrusions from said trap proximal end, a
most proximal protrusion that is the closest of the protrusions to
the trap proximal end, and a middle protrusion that is positioned
in between the most distal protrusion and proximal protrusion;
g) said recesses and said connecting portions not
engaging the vessel wall;
h) the most distal of the protrusions engaging the vessel
wall for vessels having wider channels;
i) the most proximal of the protrusions contacting the
vessel wall for narrower channels; and
j) wherein each protrusion is closer to the member distal
end than to the member proximal end.
11. A blood clot filter, comprising:
a) a trap having a proximal section that includes a leading
end, a distal section that includes a trailing end, and a
longitudinal axis, the trap being collapsible toward the
longitudinal axis for insertion into a blood vessel and radially
expandable outwardly from the longitudinal axis to an
expanded configuration to contact and penetrate an inner wall
of the blood vessel to provide a downstream migration resisting
force;
b) a plurality of elongate, spaced appendages having first
ends in said proximal section that are centrally interconnected
at the longitudinal axis and remote second ends in said distal
section extending radially away from the longitudinal axis in
the expanded configuration of the trap;
c) a first plurality of said elongate spaced appendages
having a hook directed away from the longitudinal axis to
engage and penetrate the vessel inner wall in the expanded
configuration, each hook defining a maximum migration force
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Application 12/519, 717
such that a force above the maximum migration force applied to
the hook in an opposing direction of the maximum migration
force will cause the hook to straighten;
d) a second plurality of said elongate spaced appendages,
each having a distal end and an overall length and a plurality of
bends connected end to end, said bends being positioned in said
distal section at said trailing end, said bends providing multiple
protruding portions that engage the vessel wall, and multiple
recessed portions spaced inwardly of the protruding portions
toward the longitudinal axis of the trap and that do not engage
the vessel wall, wherein said protruding portions include a
proximal protruding portion spaced farthest from said distal end
and a distal protruding portion that is spaced close to said distal
end·
'
e) wherein the distal protruding portion engages the
vessel wall for vessels having wider channels;
t) wherein the proximal protruding portion engages the
vessel wall for vessels having narrower channels;
g) wherein said second plurality does not have said
hooks; and
h) wherein the protruding portions and bends are located
in said distal section at said trailing end and extend
longitudinally less than half of said overall length.
19. A blood clot filter configured to be implanted within
a vessel having a vessel wall filled with blood that flows in a
downstream direction, comprising:
a) a trap having leading and trailing ends and a
longitudinal axis, the trap being collapsible toward the
longitudinal axis for insertion into a blood vessel and radially
expandable outwardly from the longitudinal axis to an
expanded configuration to contact and penetrate an inner wall
of the blood vessel to provide a downstream direction migration
resisting force;
b) the trap having a plurality of elongate, spaced
appendages having ends centrally interconnected at the
longitudinal axis and remote ends extending radially away from
the longitudinal axis and toward said trailing end in the
expanded configuration of the trap;
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Application 12/519, 717
c) said plurality of appendages including a first plurality
of elongate spaced appendages having a hook pointing away
from the longitudinal axis to engage and penetrate the vessel
inner wall in the expanded configuration, each hook being an
anchor to retard movement of the filter in a downstream
direction, each hook formed with a maximum migration force
such that a force above the maximum migration force applied to
the hook and in a direction opposing the maximum migration
force will cause the hook to straighten;
d) said plurality of appendages including a second
plurality of appendages, each said appendage of said second
plurality having a proximal end and a distal end, a length and
multiple protruding portions that engage the vessel wall next to
said trailing end, said protruding portions including a tip to
penetrate the vessel inner wall and configured to resist upstream
movement, said tip forming an acute angle with the said
longitudinal axis, said tip angled away from the said leading
end so that the tip does not dig further into the vessel wall upon
any downstream movement of the trap;
e) a connecting portion that connects one protruding
portion to another protruding portion, said connecting portion
spaced inwardly of the protruding portions toward the
longitudinal axis of the trap and not engaging the vessel wall;
t) a stop that is in between the tip and the leading end to
limit the depth to which the tip can penetrate the vessel inner
wall;
g) wherein the stop engages the vessel wall in between
said proximal end and said tip and next to said tip; and
h) wherein both the tip and the stop are closer to the
distal end than to the proximal end.
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Application 12/519, 717
The claims stand rejected as follow:
Claims 13 and 17 have been rejected under 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement. 2
Claims 1-7, 10, and 43 have been rejected under 35 U.S.C. § 102(b)
as anticipated by Lefebvre. 3
Claims 19 and 20 have been rejected under 35 U.S.C. § 102(b) as
anticipated by WasDyke. 4
Claims 11-13, and 15-17 have been rejected under 35 U.S.C.
§ 103(a) as obvious over Weaver5 in view ofWeldon. 6
Claims 14 and 18 have been rejected under 35 U.S.C. § 103(a) as
obvious over Weaver in view of Weldon in further view of Kim. 7
WRITTEN DESCRIPTION
Issue
The issue with respect to this rejection is whether the evidence of
record supports the Examiner's conclusion that claims 13 and 17 do not
satisfy the written description requirement.
The Examiner finds that because claims 13 and 1 7 depend from claim
11 which calls for the protrusions to extend inwardly towards the
2 Claims 1-12, 14--16, 18 and 43 were also rejected under 35 U.S.C. § 112,
first paragraph. Final Act. 5---6. The Examiner withdrew the rejection as to
these claims. Ans. 2.
3 Lefebvre, US 4,990,156, issued Feb. 5, 1991 ("Lefebvre").
4 WasDyke, US 2004/0158274 Al, published Aug. 12, 2004 ("WasDyke").
5 Weaver, US 2004/0186510 Al, published Sept. 23, 2004 ("Weaver").
6 Weldon et al., US 6,468,290 Bl, issued Oct. 22, 2002 ("Weldon").
7 Kim et al., US 6,391,045 B 1, issued May 21, 2002 ("Kim").
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Application 12/519, 717
longitudinal axis, the limitation in claims 13 and 1 7 calling for "the second
plurality of appendages [being] repeatedly bent in the circumferential
direction to form undulations that define the multiple protruding portions"
requires the appendages to have protrusions which extend in both the
circumferential and radial directions. Final Act. 6.
While Appellant addressed the written description for clams 1-18 and
43 generally, Appellant did not specifically address the issue raised by the
Examiner with respect to claims 13 and 17. See Appeal Br. 9-11. Instead,
Appellant argues generally that the claims are supported by the entire
disclosure, including the drawings. Appeal Br. 10-11. In the Answer, the
Examiner finds that while Appellant's arguments are persuasive for most of
the claims, there is no support for the limitations in claims 13 and 17. Ans.
3. Appellant did not address the issue in his reply. See Reply Br. 1--4.
Since Appellant has offered no arguments or evidence to show how
the limitations in claims 13 and 17 are supported by the instant disclosure
including the drawings, we affirm this rejection.
ANTICIPATION
Lefebvre
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that claims 1-7, 10, and 43
are anticipated by Lefebvre.
The Examiner finds that Lefebvre discloses a filter having two sets of
individual members which define a trap. Final Act. 7. The Examiner finds
that one set of members includes a surface which can engage a blood vessel
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Application 12/519, 717
wall in order to resist downstream movement. Id. The Examiner also finds
that the members of the second set include a surface which can engage the
vessel wall so as to resist upstream movement. Id. The Examiner finds that
Lefebvre discloses that the second surfaces include a plurality of at least
three spaced apart protrusions next to the distal end of the members with
recesses between the protrusions. Id.
Appellant contends that Lefebvre does not anticipate in that Lefebvre
does not teach all the elements of the claims. Appeal Br. 11, Reply Br. 2-3.
Specifically, Appellant argues that Lefebvre does not teach recesses between
the protrusions as well as the connecting portions that do not engage the
vessel wall. Id.
Appellant has the better position. Claim 1 requires that the recesses
and the connecting portions between the protrusions do not touch or engage
the vessel wall. This is demonstrated by the annotated version of Figure 4A
of the instant application shown below.
Fig. 4A
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Application 12/519, 717
Annotated Figure 4A from the present disclosure. The figure
has been annotated to identify the protrusions that touch the vessel
wall and the recesses that do not touch the vessel wall.
Figure 2 of Lefebvre on the other hand shows the recesses between
the protrusions contacting or engaging the vessel walls.
10
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12
13
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12
_.,.._... __ ···... ··1·3·····--·····t~~-e_c_e_ss ___ ~
~­,,
[vessel Wall
Annotated Portion of Figure 2 of Lefebvre filter seen in plan view,
implanted in a blood vessel.
We agree with Appellant that Lefebvre does not teach that the recesses do
not engage the vessel wall.
The Examiner contends that the recesses and connecting portions of
Lefebvre are capable of not engaging the vessel wall depending on the
characteristics of the vessel wall. Ans. 4. We are not persuaded. Lefebvre
clearly shows the vessel wall filling and contacting the recesses between the
protrusions. The Examiner has pointed to nothing in Lefebvre which would
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Application 12/519, 717
suggest that the recesses do not contact the vessel wall and the Examiner has
provided no evidence or persuasive reasoning supporting an inherency
argument.
Claims 2-7, 10, and 43 depend from claim 1 and therefore include all
the limitations of claim 1. 35 U.S.C. § 112. Since Lefebvre does not teach
all the limitations of claim 1, it follows that it does not teach all of the
limitations of the dependent claims.
We conclude that a preponderance of the evidence does not support
the Examiner's conclusion that claims 1-7, 10, and 43 are anticipated by
Lefebvre.
WasDyke
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that claims 19 and 20 are
anticipated by WasDyke.
The Examiner finds that WasDyke discloses a filter trap having a
plurality of elongate, spaced appendages having ends centrally connected at
the longitudinal axis and remote ends. Final Act. 9. The Examiner finds
that one set of appendages have hooks formed at the remote ends which
point away from the longitudinal axis. Id. The Examiner finds that the filter
also has a second set of appendages which have multiple protruding portions
that engage the vessel wall as well as a tip which penetrates the vessel wall.
Appellant argues that WasDyke does not disclose the claimed
protruding portions required by the claims. Appeal Br. 11.
Appellant has the better argument. Claim 19 requires the presence of
multiple protrusions each of which has a tip which penetrates the vessel
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Application 12/519, 717
wall. See claim 19 above. As shown in Figure 9 below, the appendages of
WasDyke only possess one protrusion which engages the vessel wall and a
separate tip 13 6 which engages the vessel wall.
Since WasDyke does not teach the presence of additional protrusions on the
appendages or multiple protrusions having a tip which penetrates the vessel
wall, it cannot anticipate the claims.
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Application 12/519, 717
The Examiner points to element 136 as being one of the two
protrusions on the appendages ofWasDyke. Final Act. 10, Ans. 5-6. We
are not persuaded. WasDyke describes element 136 as a "hook, pin, needle,
prong, barb, wedge or other piercing means 136 [which] may be used to
permanently engage and secure each tubular member 128 to the wall of the
vessel." WasDyke i-f 28. The tip 136 of WasDyke is separate from the
protrusion shown in WasDyke. See Figure 9 above. WasDyke does not
teach the limitation of claim 19 which calls for "multiple protruding portions
that engage the vessel wall next to said trailing end, said protruding portions
including a tip to penetrate the vessel inner wall." Appeal Br. 19-20
(Claims App'x).
Claims 20 depend from claim 19 and therefore includes all the
limitations of claim 19. 35 U.S.C. § 112, fourth paragraph. Since WasDyke
does not teach all the limitations of claim 19, it follows that it does not teach
all of the limitations of claim 20.
We conclude that a preponderance of the evidence does not support
the Examiner's conclusion that claims 19 and 20 are anticipated by
WasDyke.
OBVIOUSNESS
Weaver combined with Weldon
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that claims 11-13 and 15-
17 would have been obvious over Weaver combined with Weldon.
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Application 12/519, 717
The Examiner finds that Weaver discloses a filter having a plurality of
elongate, spaced appendages that are interconnected at the longitudinal axis
with remote ends. Final Act. 11. The Examiner finds that Weaver teaches
that the filter comprises a first set of appendages that have hooks capable of
engaging and penetrating the vessel wall. Id. The Examiner also finds that
the filter comprises a second set of appendages with bends that form
protrusions which are capable of engaging a vessel wall. Id. While the
Examiner finds that Weaver does not disclose appendages without hooks,
this is taught by Weldon. Final Act. 11. The Examiner concludes
It would have been obvious to one of ordinary skill in the art to
modify the device taught by Weaver '510 by providing only the
first set of appendages with hooks, as taught by Weldon'290,
because this particular known technique [i]s recognized as part
of the ordinary capabilities of one skilled in the art.
Id. at 12.
Appellant argues that Weaver does not disclose the multiple
protrusions recited in claim 11. Appeal Br. 12. Appellant also argues that in
Weaver, only the hook engages the vessel wall, not the bends cited by the
Examiner. Id.
A proper 35 U.S.C. § 103 analysis requires "a searching comparison
of the claimed invention-including all its limitations-with the teaching of
the prior art." In re Ochiai, 71F.3d1565, 1572 (Fed. Cir. 1995).
We again find that Appellant has the better argument. While the
appendages in Weaver have a series of bends, as shown in Figure 3 below,
the bends do not engage the vessel wall.
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Application 12/519, 717
__ ....._-·-·-----·-----~- ........... __ ....._ ___ . ~·--~---~---
J'i9.3
14
Figure 3 of Weaver showing filter in place in a blood vessel.
Figure 3 of Weaver demonstrates that even if the hook portion of the
appendage were removed, the bumps or protrusions would not engage the
vessel wall, but only the distal end of the appendage would engage or
contact the wall.
The Examiner contends that, depending on the nature of the blood
vessel, the bumps or protrusions are capable of engaging the vessel wall.
Ans. 6. We are unpersuaded. Figure 3 above clearly shows that the
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appendages of Weaver are designed such that only the distal ends engage the
vessel wall. This conclusion is reinforced by Figures 4 and 5 reproduced
below.
Figures 4 is an exploded view of the distal portion of a filter leg from
the first set of filter legs, showing the filter leg engaged along the
vessel wall and Figure 5 is an exploded view of the distal portion of a
filter leg from the second set of filter legs, showing the filter leg
engaged along the vessel wall.
Both figures show that it is the distal end of the appendages that
engages the vessel wall. See also, Weaver i-fi-128-31.
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Application 12/519, 717
We conclude that a preponderance of the evidence does not support
the Examiner's conclusion that claims 11-13 and 15-17 would have been
obvious over Weaver combined with Weldon.
Weaver combined with Weldon and Kim
The Examiner has rejected claims 14 and 18 as obvious over Weaver
combined with Weldon and Kim. Claims 14 and 18 depend from claim 11
discussed above and include all the limitations of claim 11. As discussed
above, the combination of Weaver and Weldon does not teach all of the
limitations of claim 11. The Examiner has not pointed to any teaching in
Kim to remedy the deficiencies of Weaver and Weldon. We therefore
conclude that claims 14 and 18 would not have been obvious over Weaver
combined with Weldon and Kim.
SUMMARY
We affirm the rejection of claims 13 and 17 under 35 U.S.C. § 112,
first paragraph.
We reverse the rejections based on 35 U.S.C. § 102(b).
We reverse the rejections under 35 U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
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