Ex Parte Gurskis et al

Patent Trial and Appeal Board

Jun 13, 2017

13292889 (P.T.A.B. Jun. 13, 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.
13/292,889 11/09/2011 Donnell William GURSKIS 10546-703.200 9508
66854 7590 06/15/2017
SHAY TtT FNN T T P
EXAMINER
2755 CAMPUS DRIVE PLATES KI, ERIN M
SUITE 210
SAN MATEO, CA 94403 ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
06/15/2017 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):
info@ shayglenn.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DONNELL WILLIAM GURSKIS, ROBERT BILGOR PELIKS,
HUGH EDWARD MAGEN, ROXANNE DANIELS,
and STEVEN ROBERT BACICH
Appeal 2016-005915
Application 13/292,8891
Technology Center 3700
Before ULRIKE W. JENKS, DEVON ZASTROW NEWMAN, and
DAVID COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of delivering vapor to a patient’s uterus. The Examiner rejected the claims
on appeal under 35 U.S.C. § 103(a) as obvious.
We REVERSE.
1 According to Appellants, the real party in interest is Aegea Medical, Inc.
App. Br. 2.
Appeal 2016-005915
Application 13/292,889
STATEMENT OF THE CASE
The Specification teaches that “[ejndometrial ablation (i.e., the
removal or destruction of the endometrial lining of the uterus) is used as an
alternative to hysterectomy for treating menorrhagia, or other uterine
diseases.” Spec. 14. The Specification discloses that known methods to
ablate the endometrium include “injecting hot fluid into the uterus” and
using “[h]igh frequency, or radiofrequency (RF), energy ... to perform
thermal ablation of endometrial tissue.” Id. at || 5 and 6. The Specification
discloses “a method and system of providing therapy to a patient’s uterus.”
Id. at Abstract.
Claims 1—3, 5, 8—11, and 32 are on appeal. Claim 1, the only
independent claim, is illustrative and reads as follows:
1. A method of delivering vapor to a uterus of a patient,
comprising:
inserting a portion of a uterine ablation device into the
uterus of the patient;
inflating a distal balloon of the uterine ablation device in
the uterus;
inflating a proximal balloon of the uterine ablation device
against a cervical canal of the patient, against an external os of
the patient, and into a vagina of the patient to pull the uterine
ablation device proximally and place the distal balloon against
an internal os of the patient;
inflating a central balloon within the cervical canal; and
delivering a heated vapor to the uterus to ablate uterine
tissue.
App. Br. 9 (Claim App.).
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Appeal 2016-005915
Application 13/292,889
The Examiner rejected claims 1—3, 5, 8—11, and 32 under 35 U.S.C.
§ 103(a) as obvious over Sharkey,2 Beyer,3 Hibler,4 and Atad.5
ANALYSIS
Sharkey discloses methods and an apparatus for endometrial ablation
using heated vapor. Sharkey 1105. Figure 37 of Sharkey (reproduced
below) discloses an embodiment of Sharkey’s apparatus for use with the
method of delivering vapor to treat a uterus. Id. at | 82.
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The apparatus of Figure 37 includes “vapor delivery] component 16
[which] is held away from the walls of the introducer by the basket arms 56
and 58” {id. at 1113), “sealing balloon 98 . . . [which] may be inflated with
fluid from an inlet port 100 to seal the uterine cavity prior to introduction of
vapor through the vapor delivery component” {id. at 1115), and “an outer
2 Sharkey et al., US Patent Publication No. 2009/0054871 Al, published
Feb. 26, 2009 (“Sharkey”).
3 Beyer et al., US Patent Publication No. 2007/0288051 Al, published Dec.
13, 2007 (“Beyer”).
4 Hibler, US Patent Publication No. 2007/0032814 Al, published Feb. 8,
2007 (“Hibler”).
5 Atad, US Patent Publication No. 2006/0058831 Al, published Mar. 16,
2006 (“Atad”).
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Appeal 2016-005915
Application 13/292,889
water jacket 101 (e.g. a balloon. . .)” that protects tissues “from the thermal
source with a flowing coolant component.” Id. at | 117.
In finding claims 1—3, 5, 8—11, and 32 to be obvious, the Examiner
found that Sharkey taught, inter alia, a uterine ablation device with a distal
anchor, which the Examiner identified as the basket (shown in Figure 37 as
having arms 56 and 58). Ans. 3^4. The Examiner acknowledged that the
Sharkey does not teach that the basket is a balloon that can be inflated, but
noted Beyer’s teaching that a distal uterine anchor may take the form of an
inflated balloon. Id. The Examiner concluded that it would have been
obvious to the skilled artisan to “use an inflatable anchor balloon [as the
distal anchor] as taught by Beyer because balloons allow for both anchoring
and sealing, which may be desirable in some applications of the invention.”
Id. The Examiner explained that “[t]he purpose of adding a balloon would
be to provide a backup to the sealing and to make the seal more secure,”
noting “two seals would be more effective than one seal, particularly when
dealing with irregular shapes such as a body’s anatomy.” Id. at 11. The
Examiner further explained that “[a] double seal provides a backup in case
of a partial or complete failure of the first seal.” Id.
Appellants argue, inter alia, that there is no rational basis for
modifying Sharkey’s expansion mechanism — i.e. the basket —to form a
balloon. App. Br. 4. Appellants contend that, contrary to the Examiner’s
articulated rationale, making the expansion mechanism a balloon would not
“provide any additional sealing benefit [because] that function is already
performed by balloon 98.” Id. Appellants also question how, mechanically,
making the expansion mechanism a balloon would provide a sealing benefit
as the expansion mechanism is positioned behind (or distal to) the sealing
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Appeal 2016-005915
Application 13/292,889
balloon 98. Id. Appellants further argue that Sharkey’s basket is “designed
to ‘open up the uterine cavity and to keep tissue away from the vapor outlets
of the vapor delivery component’” and it is “unclear how replacing this
expansion mechanism with a simple balloon would be able to achieve the
goal of expanding the uterine cavity and keeping tissue away from the vapor
ports.” Id. at 7.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
“[T]he examiner bears the initial burden ... of presenting a prima facie case
of unpatentability.” Appellants have persuaded us that the Examiner has not
carried the burden of establishing that the claimed invention would have
been obvious over the cited art.
Sharkey teaches that the basket keeps uterine tissue away from the
vapor delivery ports (Sharkey 1106) and that an already existing “sealing
balloon” “seal[s] the uterine cavity prior to introduction of vapor.” Id. at
1115. In view of these teachings, the Examiner’s articulated rationale — that
the skilled artisan would have been motivated to add a “backup seal” and
that two seals are better than one (see Ans. is 3^4 and 11) — is not sufficient.
The Examiner has not identified any teaching in the art suggesting that a
backup seal is necessary or desirable. Nor has the Examiner explained how
uterine tissue would be kept away from the vapor ports — a function of
Sharkey’s basket — if the basket were replaced with a balloon. Moreover, we
agree with Appellants that it is not clear that replacing Sharkey’s basket with
a balloon would better seal the uterus than using Sharkey’s sealing balloon
98 alone. Since the Examiner’s proposed new balloon would be behind the
sealing balloon, it is not clear how the new balloon would provide sealing
benefit beyond that already provided by the sealing balloon.
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Appeal 2016-005915
Application 13/292,889
Finally, we note that the Examiner has not made clear that the
proposed modification of Sharkey would, in fact, result in an ablation device
configured as claimed. The Examiner identifies balloon 98 as corresponding
to the claimed central balloon. Ans. 5. But in Sharkey, balloon 98 is
positioned in the uterus, not in the cervical canal as required by claim 1.
Replacing Sharkey’s basket with a balloon would result in two balloons in
the uterus, and the Examiner provides no reason to move either balloon into
the cervical canal, which is already occupied by a balloon — i.e. Sharkey’s
inflatable water jacket. Accordingly, we reverse the Examiner’s rejection of
claims 1—3, 5, 8—11, and 32 as obvious over Sharkey, Beyer, Hibler, and
Atad.
SUMMARY
For the reasons provided herein we reverse the Examiner’s decision to
reject claims 1—3, 5, 8—11, and 32 under 35 U.S.C. § 103(a) as obvious over
Sharkey, Beyer, Hibler, and Atad.
REVERSED
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