Ex Parte MacLean

Patent Trial and Appeal Board

Sep 28, 2017

13777117 (P.T.A.B. Sep. 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.
13/777,117 02/26/2013 Brian MacLean 10124/10602(1100325US01) 5484
104919 7590 10/02/2017
Fay Kaplun & Marcin, LLP — BSC
150 Broadway, suite 702
New York, NY 10038
EXAMINER
SCHERBEL, TODD J
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
10/02/2017 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):
okaplun@fkmiplaw.com
fkmiplaw @ yahoo. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRIAN MACLEAN
Appeal 2016-008349
Application 13/777,1171
Technology Center 3700
Before TONI R. SCHEINER, RYAN H. FLAX, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a medical
device for ablating tissue within a body cavity. The Examiner entered final
rejections for anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE.
1 Appellant identifies the Real Party in Interest as Boston Scientific Scimed,
Inc. App. Br. 2.
Appeal 2016-008349
Application 13/777,117
STATEMENT OF THE CASE
Background
“Embodiments of the present disclosure relate generally to medical
devices suitable for use in medical procedures. In particular, embodiments
of the instant disclosure relate to medical devices and methods that include
body tissue manipulation.” Spec. 12. “Embodiments of the present
disclosure direct towards systems and methods for tissue ablation within a
body cavity.” Id. 1 8.
The Claims
Claims 1—11 are on appeal. Final Act. I.2 The sole independent
claim, claim 1, is illustrative and reads as follows:
1. A medical device for ablating tissue within a body
cavity, comprising:
a sheath having a lumen extending therethrough from a
proximal end to a distal end and first and second channels
extending within the lumen;
an end-effector insertable into the first channel extending
from a proximal end to a distal end and including an
expandable member having a plurality of arms extending
between the proximal end and the distal end, the arms being
configured to transition between a collapsed state and an
expanded state in which the arms hold a target body cavity in
an expanded configuration; and
a mechanism for transporting a fluid through the second
channel to the body cavity to ablate the tissue.
App. Br. 8 (Claims Appendix) (emphasis added).
2 Examiner’s Final Action, mailed October 28, 2015.
2
Appeal 2016-008349
Application 13/777,117
The following rejections are before us to review:
Claims 1—5 and 8—11 are rejected under pre-AIA 35 U.S.C.
§ 102(b) as anticipated by Edwards.3 Ans. 2.
Claims 6—7 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Edwards in view of Evans.4 Id.
DISCUSSION
The Examiner has rejected all of the claims on appeal as either
anticipated by Edwards or obvious based on Edwards in view of Evans. The
same issue is dispositive for each rejection.
The Examiner finds that Edwards discloses a medical device meeting
all of the limitations of independent claim 1. Final Act. 4—5.
Appellant argues that Edwards does not anticipate because Edwards
“fails to teach or suggest ‘an end-effector insertable into [a] first channel,’ as
recited in claim 1.” App. Br. 3. Appellant argues that the expansion device
of Edwards, which the Examiner identifies as the end effector (Final Act. 4)
“is coupled at its proximal end to the distal end of a flexible elongate shaft
such that it never extends into or is inserted within the lumen of the shaft.”
Id.
We agree with Appellant that Edwards does not meet the limitations
of claim 1. Edwards discloses a medical device having an expandable
basket structure with a first energy delivery device that can create a “desired
tissue effect.” Edwards Abstract. Edwards’ basket device is shown in
Figure 10, reproduced below:
3 US 6,009,877, issued January 4, 2000 (“Edwards”).
4 US 5,542,928, issued August 6, 1996 (“Evans”).
3
Appeal 2016-008349
Application 13/777,117
Figure 10 “is a lateral view of a sphincter treatment apparatus, useful with
the method of the present invention, illustrating the deflection mechanism.”
Edwards. 4: 35—38. Edwards discloses that “in FIG. 10, deflection
mechanism 84 includes a second pull wire 80’ attached to shaft cap 78 and
also to a movable slide 86 integral to proximal fitting 34.” Edwards 8:18—
21. Figure 4, reproduced below, depicts the attachment of the basket device
to the shaft (18):
5!
FIG,-4
Figure 4 “illustrates a lateral view of a basket assembly that can be used in
the method of the present invention.” Id. at 4:9—10. Appellant argues the
4
Appeal 2016-008349
Application 13/777,117
expansion device 20 [basket assembly] includes elongated arms
44 that are joined at their proximal ends 46 which [a]re attached
to a supporting structure at the distal end 32 of the shaft 18 or
proximal cap 51. See Id., col. 6,11. 55-62. That is, because the
end effector, or expansion device 20, is coupled to the
supporting structure located at the distal end of the shaft 36, it is
in no way insertable into the lumen of the shaft 36. At no point
in its entirety does Edwards suggest that the expansion device
20 may be inserted within the lumen 36 of the shaft 18, nor
does Edwards provide any motivation for the expansion device
20 to be inserted therein.
App. Br. 3.
The Examiner reasons that the expansion device 20 “includes pull
wire 80’ in FIG. 10 [which] can reasonably be considered part of the
expansion device 20 since it is used to actuate the expansion device 20 in
FIG. 10 and col. 8, Ins. 18-21.” Ans. 2. The Examiner finds that
[t]he pull wire 80’ is insertable into a first channel in the form
of lumen 36 as is shown in FIG. 10 and discussed at col. 6, Ins.
36-41 and col. 8, Ins. 18-21. Specifically, Edwards teaches that
“[s]haft 18 may have one or more lumens 36, that extend the
full length of shaft 18, or part way from shaft proximal end 30
to shaft distal end 32. Lumens 36 may be used as paths for ...
pull wires” (col. 6, Ins. 36-41).
Ans. 2—3. The Examiner further finds that Edwards teaches that “deflection
mechanism 84 includes a second pull wire 80’ attached to shaft cap 78 and
also to a movable slide 86 integral to proximal fitting 34,” which the
Examiner finds “teaches the pull wire 80’ in FIG. 10 being insertable into a
channel or lumen of the shaft 18.” Id.
We do not find this reasoning persuasive. Claim 1 requires that the
end effector comprise the arms: “an end-effector insertable into the first
channel extending from a proximal end to a distal end and including an
expandable member having a plurality of arms extending between the
5
Appeal 2016-008349
Application 13/777,117
proximal end and the distal end.” The Specification supports these
requirements, stating: “[a]n end effector, disposed at the distal end of the
sheath, includes a proximal end, a distal end, and an expandable member
having arms extending between its proximal end and the distal end. The
arms are configured to transition between a collapsed state and an expanded
state.” Spec. 19. Therefore, we find the end effector comprises arms that
alternate between the collapsed and expanded states. Id.
The Specification further explains that the “expandable member
remains collapsed within a working channel of the sheath during insertion
and retrieval of the device. Once deployed to a desired position within a
target body cavity, the expandable member is extended from the distal end
of the sheath and expanded radially outward.” Spec. 121. The
Specification continues, with reference to Figure 1: “[t]he device 100 also
includes one or more working channels 114 running within the lumen 108 of
the 20 sheath 102 from its proximal end 106 to its distal end 104.” Figure 1
of the Specification is reproduced below:
,100
Figure 1 “is a schematic view of an exemplary medical device according to
embodiments of the present disclosure.” Id. 113.
6
Appeal 2016-008349
Application 13/777,117
These disclosures from the Specification explain that the lumen
contains one or more working channels, which are recited to be separate
features in claim 1: “a sheath having a lumen extending therethrough from a
proximal end to a distal end and first and second channels extending within
the lumenWhere a claim lists elements separately, “the clear implication
of the claim language” is that those elements are “distinct component[s]” of
the patented invention. Becton, Dickinson and Co. v. Tyco Healthcare
Group, LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010) (citing Gaus v. Conair
Corp., 363 F.3d 1284, 1288 (Fed. Cir. 2004); Engel Indus., Inc. v.
Lockfiormer Co., 96 F.3d 1398, 1404—05 (Fed. Cir. 1996) (concluding that
where a claim provides for two separate elements, a “second portion” and a
“return portion,” these two elements “logically cannot be one and the
same”)). Accordingly, to meet the limitation “an end-effector insertable into
the first channel extending from a proximal end to a distal end” of claim 1,
the basket assembly of Edwards must comprise arms that alternate between
the collapsed and expanded states, and the assembly must insert within one
of the channels that is housed within the lumen, and not simply the lumen
itself, which is a separate element from the “first channel.”
Appellant argues (App. Br. 3), and we agree, the basket
assembly/expansion device of Edwards is attached to the supporting
structure at the distal end 32 of the shaft. In relevant part, Edwards states:
Referring now to FIG. 4, in one embodiment of the
present invention, expansion device 20 comprises one or more
elongated arms 44 that are joined at their proximal ends 46 and
distal ends 48 to form a basket assembly 50. Proximal arm end
46 is attached to a supporting structure, which can be the distal
end 32 of shaft 18 or a proximal cap 51. Likewise, distal arm
7
Appeal 2016-008349
Application 13/777,117
end 48 is also attached to a supporting structure which can be a
basket cap 52 or shaft 18.
Edwards at 6:55—63. Because Edwards’s arms are attached to a supporting
structure, as shown in Figure 4 above, we agree with Appellant that the
basket assembly is not “insertable into a first channel” as required by claim
1. The Examiner has not pointed to any disclosure in Edwards to show
otherwise. Moreover, even if we were to agree with the Examiner that pull
wire 80 met the limitation “insertable into a first channel” by interpreting a
first channel to comprise one of the lumens 36 of Edwards, the pull wire
alone does not comprise the end effector because it does not comprise the
arms that facilitate transition between the collapsed and expanded states, as
discussed above.
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Accordingly, because the limitation “insertable into the first channel” is not
met under the Examiner’s rationale for anticipation and/or obviousness, we
conclude a prima facie case is not presented for either rejection and reverse
the rejection of claim 1 as anticipated by Edwards and the rejection of claims
6 and 7 as obvious over Edwards and Evans because it is also based on the
Examiner’s finding that Edwards anticipates claim 1. (See Final Act. 6—7.)
SUMMARY
We reverse both rejections on appeal.
REVERSED
8