Ex Parte Koehler

Patent Trial and Appeal Board

Jul 28, 2017

13005957 (P.T.A.B. Jul. 28, 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.
8627-2966 3537
EXAMINER
STRANSKY, KATRINA MARIE
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
13/005,957 01/13/2011
48003 7590 O’
BGL/Cook - Chicago
PO BOX 10395
CHICAGO, IL 60610
Cleve Koehler
07/31/2017 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 CLEVE KOEHLER1
Appeal 2016-004964
Application 13/005,957
Technology Center 3700
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a filter
and method for capturing and treating blood clots in a vessel. The claims
have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Appellant’s “invention relates to a removable vena cava clot filter that
can be employed to capture and treat blood clots in the vena cava of a
1 Appellant identifies the Real Party in Interest as Cook Medical
Technologies. (App. Br. 2.)
Appeal 2016-004964
Application 13/005,957
patient.” (Spec. 11.) According to the Specification, “existing vena cava
filters do not provide a means of treating captured blood clots.” {Id. 14.)
The Specification’s figures help to illustrate Appellant’s invention.
Fig. 2 from the Specification is reproduced below.
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Fig. 2
Fig. 2 is a side view of an embodiment of Appellant’s filter (10) in an
expanded state. {Id. 130.) As shown, the filter includes, inter alia, hub (12)
and a plurality of struts (22a and 22b) that move between an expanded state
for capturing and treating blood clots and a collapsed state for delivery or
retrieval of the filter. {Id. ]Hf 30, 32.) A tubular member (32) is disposed
through hub (12) and has a proximal end (34) and distal end (36), which may
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Application 13/005,957
be open or closed. (/J. H 33—34.) The tubular member’s distal portion
includes perforations (44) (e.g., small holes); fluid introduced into the
proximal end of the tubular member escapes through the perforations and
thus treats clots captured by the filter. (Id. || 28, 37.)
Claims 1—20 are on appeal. Claim 1 is illustrative:
1. A filter for capturing and treating blood clots in a blood
vessel, the filter comprising:
a hub having a distal end and a proximal end;
a plurality of struts extending distally from the hub and
having distal strut ends located radially outward from the hub in
an expanded configuration; and
a tubular member disposed through the hub, the tubular
member having a distal end and a proximal end and extending
along a central longitudinal axis when the struts are in the
expanded configuration, the tubular member having a distal
portion extending from the distal end of the hub to the distal end
of the tubular member, an intermediate portion extending
through the hub from the proximal end of the hub to the distal
end of the hub, and a proximal portion extending from the
proximal end of the hub to the proximal end of the tubular
member, the distal portion, the intermediate portion, and the
proximal portion being in fluid communication via a lumen
extending inside the tubular member, the distal portion of the
tubular member having a plurality of perforations, and the
proximal end having an opening in communication with the
lumen and with the perforations, the opening being located
relative to the hub longitudinally opposite the plurality of struts
and configured to be attached to a catheter.
(App. Br. 13 (Claims App.) (emphasis added).)
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Application 13/005,957
The claims stand rejected as follows:
I. Claims 1—18 under 35 U.S.C. § 103(a) over Wessman2 and
Evans.3
II. Claims 19 and 20 under 35 U.S.C. § 103(a) over Wessman,
Evans, and Chiu.4
I
Issue
Has the Examiner established by a preponderance of the evidence that
claims 1—18 would have been obvious over Wessman and Evans?
Findings of Fact (FF)
FF 1. Wessman teaches a filter assembly deployable in a vessel of the
body in either a temporary configuration enabling the filter to be removed
from the vessel, or a permanent configuration. (Wessman Abstract.)
Wessman’s filter assembly has an elongated support that includes, along its
length, a filter element and an anchoring element. (Id.) Wessman teaches
“[t]he filter assembly may include a hollow flexible tether releasably
attached to the proximal end of the elongated support.” (Id.)
FF 2. Wessman teaches the “tethered or temporary configuration of
the filter assembly enables a fluid such as a contrast medium to be injected
from the hollow tether and through or around the elongated support.” (Id. 1
22.) More specifically, Wessman teaches:
2 Wessman et al., US 2001/0000799 Al, published May 3, 2001.
3 Evans et al., US 2003/0139751 Al, published July 24, 2003.
4 Chiu, US 2004/0064099 Al, published Apr. 1, 2004.
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Application 13/005,957
[T]he elongated support is tubular and serves as an infusion tube
that extends distally from the apex of the filter element to enable
a contrast medium or drug or other liquid to be injected into the
vena cava just distally of (that is, upstream from) the apex of the
filter element so that the fluid immediately encounters any
captured blood clots and enables them to be visualized or
dissolved or otherwise treated, as the case may require. In this
embodiment, the flexible tether is tubular and is attached at its
distal end to the tubular support in fluid communication
therewith to supply contrast medium or drug to the infusion tube,
the proximal end of the tether being accessible for this purpose
outside the body.
{Id. 119 (emphasis added); see also id. 127.)
FF 3. Figs. 1 and 3 of Wessman are reproduced side-by-side below.
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Application 13/005,957
Figs. 1 and 3 are cross-sectional side views of the filter assembly; Fig. 1
shows the assembly with only the filter element (6) deployed and Fig. 3
shows both the filter element (6) and the anchoring element (8) wires
deployed. {Id. ]Hf 29, 31.) As shown in Figs. 1 and 3, the assembly includes
a cylindrical core (6.1) from which extend circumferentially spaced wires
(6.2.), as well as an elongated, tubular support (20) having distal (20.1) and
proximal (20.2) ends. {See, e.g., id. 140.) Fig. 1 shows a tubular tether
(26), which includes a rigid distal constraining tube portion (28). {Id. 146;
see also id. Fig. 6 (depicting distal tube portion (28) and the long, flexible,
tubular proximal portion (30) of tether (26).)
FF 4. Wessman teaches “[t]o permanently deploy the filter assembly
[such as shown in Fig. 3], a flexible release rod may be inserted into the
tether and passed along into contact with the lock that releasably locks the
tether to the elongated support.” {Id. 124; see also ^fl[ 45, 48, and Figs. 6
and 7 (showing release rod (36) positioned within the tether and being
advanced to engage resilient fingers (12.2) of tubular locking member (12),
thus allowing the fingers to move out of contact with the tether’s annular
shoulder (28.3) and the tether to be withdrawn proximally.) Wessman
teaches proximal withdrawal of the tether permits the wires (8.2) of the
anchoring element to expand and deploy within the blood vessel. {Id. 148.)
FF 5. Evans teaches “[c]lot disruption and dissolution are achieved
using a catheter having the ability to infuse a thrombolytic agent, agitate the
clot and agent, and aspirate broken-up clot from the blood vessel.” (Evans
Abstract.) Evans teaches a tubular sheath that includes a plurality of fluid
distribution ports, which are formed over a portion of the sheath and through
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Application 13/005,957
which a thrombolytic agent is passed to contact and disrupt the clot. (Id. 1
88; see also id. Fig. 2 (showing sheath (32) and ports (40).)
Analysis
Claims 1, 10, 15
The Examiner rejected claims 1,10, and 15 as obvious over the
combination of Wessman and Evans. The Examiner finds that Wessman
teaches a filter assembly for capturing and treating blood clots, and that the
assembly includes, inter alia, a hub (6.1), a plurality of struts (6.2), and a
tubular member (20) disposed through the hub and having distal and
proximal ends (20.1 and 20.2, respectively). (Final Act. 3.) According to
the Examiner, Wessman further teaches the tubular member includes a
lumen extending from the distal to the proximal end, which serves as an
infusion tube for injecting fluid (e.g., agents to dissolve clots) to the distal
end of the tubular member, just distal to the filter element. (Id.) The
Examiner further finds the opening at the proximal end of Wessman’s
tubular member is configured to be attached to a catheter (i.e., Wessman’s
tubular “tether”) and that the fluid is introduced via the tether to the tubular
member. (Id. at 4; see also Ans. 3—4.)
The Examiner finds that Wessman “is silent on teaching wherein the
tubular member’s distal portion comprises a plurality of perforations such
that fluid or liquid is dispensed through these perforations.” (Final Act. 4.)
The Examiner turns to Evans as teaching a device including a tubular sheath
with a plurality of fluid distribution ports, and that fluid (e.g., thrombolytic
agent) is passed through the ports to dissolve blood clots. (Id.)
The Examiner concludes it would have been obvious to modify the
distal portion of Wessman’s tubular member to include a plurality of fluid
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Application 13/005,957
ports as taught in Evans. (Id. at 4—5.) The Examiner reasons the skilled
person would have predictably modified the art in this way to “uniformly
and evenly dispens[e] liquid such as thrombolytic agents to disrupt and
dissolve occlusive materials formed in the blood vessels.” (Id. at 5.)
We agree with and adopt the Examiner’s findings, reasoning, and
conclusion that claims 1,10, and 15 would have been obvious over
Wessman and Evans. (Final Act. 3—8; Ans. 2—6.) We address below the
Appellant’s arguments.
Appellant argues the patentability of claims 1,10, and 15 as a group.
The key dispute on appeal concerns whether Wessman teaches the claimed
attachment between the catheter (i.e., Wessman’s tether) and the opening at
the proximal end/portion of the tubular member (i.e., Wessman’s tubular
support). (App. Br. 7—9.) In this respect, Appellant notes that claim 1
recites “the opening [of the tubular member’s proximal end] being located
relative to the hub longitudinally opposite the plurality of struts and
configured to be attached to a catheter.” (App. Br. 7.) Appellant asserts
“[i]n analogy, claim 10 recites ‘the distal end of the catheter adjoining the
proximal end of the tubular member,”’ and “claim 15 recites ‘the distal end
of the catheter being attached to the proximal end of the tubular member.’”
(Id. at 8.)
Appellant argues that Wessman does not teach the claimed attachment
because Wessman’s “catheter cannot be attached to or adjoin the proximal
end (or the proximal opening) of the tubular member without rendering the
device inoperable for its intended function.” (Id. at 9.) According to
Appellant, in Wessman’s temporary configuration, “catheter 30 can be
attached to the tether 28 at location 28.1 for establishing a fluid
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communication, but the catheter cannot be attached to the tubular support
because the release rod needs to be placed over the proximal end of the
tubular member to release the anchoring element.” (Id.) Further, Appellant
contends, “fluid may enter the proximal end of the tubular member only
from the lumen of the tether, not directly from the catheter.” (Id.)
We are unpersuaded. First, Appellant attempts to draw a distinction
between a so-called catheter (30) and a tether (28) of Wessman. But
structures 28 and 30 are, in fact, portions of the same overall structure —
Wessman’s tether (26). (FF 3 4.) As Wessman makes clear, the tubular
tether (26) includes both a distal, more rigid end portion (28) and a flexible
proximal portion (30), which may extend external to the patient. (FF 3^4;
see also Wessman || 10, 14, 21, 26.) The Examiner identifies the tether as
the claimed catheter. (Final Act. 4; Ans. 3.) And it is the tubular tether 26,
including portions 28 and 30 that introduces fluid directly to the opening at
the proximal end of Wessman’s tubular support (20.2). (FF 1—2.)
Second, contrary to Appellant’s contentions, Wessman teaches that
the proximal end of the tubular support is configured to be attached to the
tether and to be in fluid communication with the tether. (See Wessman
Abstract (“a hollow flexible tether releasably attached to the proximal end of
the elongated [tubular] support”) and 119 (“the flexible tether is tubular and
is attached at its distal end to the tubular support in fluid communication
therewith”); FF \—A\ Ans. 3.) Thus, we find Wessman teaches that the
proximal end opening of the tubular member that is in communication with
the lumen is configured in such a way as to be in fluid communication with
the tether and also attached to it, even if indirectly via the tubular wall that
defines the proximal end and opening. Indeed, in the preferred embodiment
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shown in the figures, Wessman teaches that “[a]t its proximal end 20.2, the
elongated support 20 is provided with a tubular locking member 12” that
includes “a plurality of circumferentially spaced, distally extending fingers
12.2.” (M 145.) These fingers extend from the locking member at the
proximal end opening of the elongated tubular support and engage shoulder
(28.3) of the tether’s distal end portion. (FF 3^4; see also Wessman || 45—
47 and Figs 6—7.) Consequently, even this arrangement teaches an
attachment (via locking member 12) between the proximal end opening of
the tubular support and the tether/catheter and does not render Wessman’s
device inoperable.
Third, inasmuch as Appellant’s argument suggests the claims should
be read as limited to a direct, end-to-end abutting connection only,5 we are
unpersuaded that the broadest reasonable interpretation of the claims is so
narrow. To the contrary, the Specification discloses that “distal end 56 of
the catheter 52 may be fixedly attached to the proximal end 34 of the tubular
member 32” but then adds: “[i]f the catheter 52 is fixedly attached to the
tubular member 32, the attachment may be accomplished by adhesive
bonding, thermal bonding, clamping, or any other suitable means of
attachment.” (Spec. 1 50 (emphasis added); see also Spec. 1 61 (“it will be
understood that the invention is not limited to the disclosed embodiments, as
those having skill in the art may make various modifications . . . .”).) The
5 In other words, an interpretation where the catheter and tubular member
directly and physically abut and join at their respective distal-most and
proximal-most extent. By way of example, consider a catheter and tubular
member with matching internal and external diameters that are brought into
direct end-to-end engagement and thermally bonded to each other.
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Application 13/005,957
broadest reasonable interpretation of the claims thus encompasses other
suitable and well-known means of attaching the ends of two tubular
structures (e.g., male/female or nesting attachment, or an indirect attachment
with an external sleeve or collar.)
The Appellant argues that Evans does not disclose a catheter attached
or adjoining the tubular member as claimed, and thus does not remedy
Wessman’s alleged deficiencies. (App. Br. 9-10.) The Examiner is not,
however, relying on Evans for teaching the relevant limitations concerning
attaching the catheter to the tubular member. (Ans. 5.) Appellant’s
arguments concerning Evans are thus unpersuasive.
Appellant also argues there is no reason to modify the art absent
hindsight. We disagree. Wessman discloses the claimed structure with the
exception of the plurality of perforations. But Evans discloses using
multiple fluid ports (perforations) for helping to dissolve blood clots (FF 5),
and the Examiner provided a reasoned basis for including such perforations
in Wessman’s assembly. (Final Act. 4—5.) Appellant provides no
persuasive argument or evidence otherwise.
In the Reply Brief, Appellant argues the phrase “configured to” does
not mean merely “capable of.” (Reply Br. 2.) We remain unpersuaded
because, as explained above, whether “configured to be attached to a
catheter” is interpreted as “capable of,” or more narrowly as actually
“designed to” or “made to,” Wessman teaches the tether is attached to the
tubular member as claimed. We further are unpersuaded that an indirect
attachment {id. at 3.) is excluded for the reasons already discussed.
Finally, Appellant argues “adjoining” (as used in claim 10) does not
mean “adjacent” and, instead, requires “direct contact, in contrast to the
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Examiner’s assertion.” (Id.) In support, Appellant submits a dictionary
definition of the word “adjoining.” (Id.) Appellant’s argument is
unpersuasive. Appellant’s Specification does not define “adjoining” to
require the structures directly contact each other. And even the dictionary
excerpt submitted by Appellant states that “adjoining” is synonymous with
“adjacent,” and that the definition of “adjoin” encompasses “to be close to or
in contact with one another.” (Id.; see Merriam Webster’s Collegiate
Dictionary (11th ed. 2003) (excerpt submitted with Reply Brief).)
Conclusion of Law
The preponderance of the evidence on this record supports the
Examiner’s conclusion that claims 1,10, and 15 would have been obvious
over Wessman and Evans. Claims 2—9, 11—14, and 16—18 have not been
argued separately and therefore fall with claims 1, 10, and 15. 37 C.F.R.
§ 41.37(c)(l)(iv).
II
The Examiner rejected claims 18 and 19 as obvious over Wessman,
Evans, and Chiu. (Final Act. 8.) We agree with and adopt the Examiner’s
findings, reasoning, and conclusion of obviousness.
Appellant argues only that Chiu does not remedy the alleged
deficiencies of Wessman and Evans with respect to claim 15, from which
claims 19 and 20 depend. This argument is unpersuasive for the reasons
explained in Section I above.
SUMMARY
We affirm the rejection of the appealed claims for obviousness.
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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
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