Ex Parte Ostrovsky et al

Patent Trial and Appeal Board

Oct 25, 2016

11374811 (P.T.A.B. Oct. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111374,811 03/14/2006
93427 7590 10/27/2016
Brake Hughes Bellermann LLP
c/o CPA Global
900 Second A venue South
Suite 600
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Isaac Ostrovsky
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. CONFIRMATION NO.
0073-312001 9618
EXAMINER
GUPTA,VANI
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
10/27/2016 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):
docketing@brakehughes.com
uspto@brakehughes.com
PTOL-90A (Rev. 04/07)
u-NITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ISAAC OSTROVSKY, VICTOR SHUKHAT,
ALFRED P. INTOCCIA, JON T. MCINTYRE, and
TYFAIRNENY
Appeal2014-009608
Application 11/374,811
Technology Center 3700
Before LYNNE H. BROWNE, LISA M. GUIJT, and
JEFFREY A. STEPHENS, Administrative Patent Judges.
STEPHENS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants 1 seek our review under 35 U.S.C. § 134(a) from the
Examiner's Final Office Action ("Final Act.") rejecting claims 1, 4, 5, 7-23,
and 25-30, which are all the claims pending in the application. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm-in-part.
1 The real party in interest is identified as Boston Scientific Scimed, Inc.
App. Br. 2.
Appeal2014-009608
Application 11/374,811
Claimed Subject Matter
Claims 1 and 15, reproduced below, are illustrative of the claimed
subject matter.
1. A device for heating tissue, comprising:
a housing sized for insertion through a naturally occurring
body orifice to a target location within a lumen;
a heat generating element focusing thermal energy on a
target area separated from an outside of the housing so that, when
the housing is in the target location, the target area is within
tissue surrounding the lumen at a predetermined depth from a
lumenal wall wherein the heat generating clement comprises an
array of ultrasound transducers positioned within the housing
and an acoustic reflector positioned over an outer surface of the
housing and over the array of transducers, the acoustic reflector
extending away from the housing in a first direction by a first
predetermined distance toward the target area so that acoustic
energy from the ultrasound transducers is focused away from the
transducers in the first direction by a second predetermined
distance greater than the first predetermined distance;
a temperature sensing element sensing data corresponding
to a temperature of tissue in the target area; and
a processor controlling the heat generating element in
response to the data sensed by the sensing element.
15. A system for thermal tissue therapy, comprising:
a housing sized for insertion through a naturally occurring
body orifice to a target location within a lumen;
a temperature sensing element generating a signal
corresponding to a temperature of target tissue;
an energy delivery element within the housing;
an acoustic reflector positioned over an outer wall of the
housing and extending away from the housing in a first direction
by a first predetermined distance toward the target location so
that energy from the energy delivery element is focused away
from the energy delivery element in the first direction by a
second predetermined distance greater than the first
predetermined distance;
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Application 11/374,811
a temperature acquisition module computing the target
tissue temperature based on the signal of the temperature sensing
element; and
an electronic processor controlling an amount of power
supplied to the energy delivery element based on the target tissue
temperature.
Rejections
1. Claims 1, 5, 7, 8, 10-12, 15, 16, 18-22, and 26-28 stand
rejected under 35 U.S.C. § 103(a) as unpatentable over Lele (US 4,938,217,
issued July 3, 1990) (hereinafter "Lele '217"), Lele (US 4,960,109, issued
Oct. 2, 1990) (hereinafter "Lele '109"), Cline et al. (US 5,873,845, issued
Feb. 23, 1999), and Sherman et al. (US 5,735,280, issued Apr. 7, 1998).
Final Act. 2-9.
2. Claims 4, 14, 17, and 25 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Lele '217, Lele '109, Cline, Sherman, and
Crowley et al. (US 2004/0133109 Al, published July 8, 2004). Final Act.
9-10.
3. Claims 9 and 23 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Lele '217, Lele '109, Cline, Sherman, and Chen (US
4,821,838, issued Apr. 18, 1989). Final Act. 10-11.
4. Claim 13 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Lele '217, Lele '109, Cline, Sherman, and Vitek et al. (US
6,506,171 Bl, issued Jan. 14, 2003). Final Act. 11-12.
5. Claim 29 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Lele '217, Lele '109, Cline, Sherman, and Cox (US
6,083,232, issued July 4, 2000). Final Act. 12-13.
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Application 11/374,811
6. Claim 30 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Lele '217, Lele '109, Cline, Sherman, and Snyder (US
4,757,821, issued July 19, 1988). Final Act. 13-14.
ANALYSIS
Claims 1, 4, 5, 7-14, 20-23, and 25-30
Appellants argue Sherman does not teach "a temperature sensing
element sensing data corresponding to a temperature of tissue in the target
area," as recited in claim 1. App. Br. 6. In particular, Appellants point out
the "target area" recited in claim 1 is "separated from an outside of the
housing so that, when the housing area is in the target location" within a
lumen, "the target area is within tissue surrounding the lumen at a
predetermined depth from a lumenal wall." App. Br. 6-7. Appellants
contend Sherman's temperature sensing devices are located at or near the
transducer and only read the temperature of portions of tissue adjacent to the
sensing devices. Id.
We agree with Appellants that the cited portions of Sherman do not
teach a temperature sensing device that senses data corresponding to a
temperature of tissue that is located at a predetermined depth from the wall
of the lumen where the device housing is located. Although we agree with
the Examiner (Ans. 15) that claim 1 does not specify the location of the
temperature sensing element relative to the heat generating element, the
claim specifies the location of the tissue with the temperature of interest.
Under the language of the claim, the tissue in the target area is located at a
predetermined depth from the lumenal wall where the housing and heat
generating element are located. In contrast, the cited portions of Sherman
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Application 11/374,811
teach that the temperature sensor is located with the heat generating element,
and the Examiner does not provide reasoning for including Sherman's
temperature sensing element at some other location. As shown in Figure 2
of Sherman, temperature sensing devices 28 are surrounded by piezo-electric
transducer or crystal 24, which is inserted in a lumen. See also Sherman col.
6, 11. 15-17. Sherman also teaches that the temperature is sensed at the
location of the transducer where the temperature sensors are located, and the
cited portions of Sherman do not teach techniques for sensing temperature of
tissue located a predetermined depth from the luminal wall. See Sherman
col. 3, 11. 32-35 ("Thus, providing a crystal with relatively rapid thermal
conductivity, sensing the temperature at the crystal, and controlling the
energy supplied to the crystal for ablation are desirable." (emphasis added));
see also Sherman col. 13, 11. 34--49.
The Examiner also finds that even if Sherman teaches sensing
temperature at a luminal wall instead of measuring temperature of a tissue at
a predetermined depth from the luminal wall, the temperature of the luminal
wall would "correspond" to the temperature of tissue in the target area. Ans.
15. In support of this finding, the Examiner construes the claim phrase
"sensing data corresponding to the temperature of the tissue in the target
area" to include "any data related to the temperature of the target area,
including temperature of tissue near or away from the target area, as long as
it is still related in some way to the target area." Id. We agree with
Appellants that this interpretation is overly broad. As argued by Appellants
(Reply Br. 5), we interpret the claim phrase "sensing data corresponding to a
temperature of tissue in the target area" to require that the data originate
from the target area. As discussed above, Sherman teaches a temperature
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Application 11/374,811
sensor gathering data at the lmninal wall, rather than a predetermined depth
from it.
For the reasons given above, we do not sustain the rejection of claim 1
under 35 U.S.C. § 103(a) as obvious over Lele '217, Lele '109, Cline, and
Sherman. 2 For the same reasons, we do not sustain the rejections of claims
4, 5, 7-14, and 30, which depend from claim 1. Specifically, we do not
sustain the rejections under 35 U.S.C. § 103(a) of: (1) claims 5, 7, 8, and
10-12 as obvious over Lele '217, Lele '109, Cline, and Sherman; (2) claims
4 and 14 as obvious over Lele '217, Lele '109, Cline, Sherman, and
Crowley; (3) claim 9 as obvious over Lele '217, Lele '109, Cline, Sherman,
and Chen; (4) claim 13 as obvious over Lele '217, Lele '109, Cline,
Sherman, and Vitek; and (5) claim 30 as obvious over Lele '217, Lele '109,
Cline, Sherman, and Snyder.
Appellants also argue the rejections of independent claim 20 and its
dependents are in error for the same reasons as claim 1. App. Br. 12-13.
We interpret claim 20 to require that "a target portion of an endopelvic
fascia" be located a predetermined distance away from the probe (i.e., "a
second predetermined distance greater than the first predetermined
distance"). Thus, for the same reasons discussed in relation to claim 1, we
agree with Appellants that the cited portions of Sherman do not teach "a
temperature measuring element generating a signal corresponding to a
temperature of the target portion of the endopelvic fascia," as recited in
claim 20. Accordingly, we do not sustain the rejection of claim 20 or its
2 Because the issue of whether the cited combination of references teaches
the temperature sensing element recited in claim 1 is dispositive as to this
claim, we do not reach additional issues raised by Appellants related to
claim 1.
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dependents, claims 21-23 and 25-29. Specifically, we do not sustain the
rejections under 35 U.S.C. § 103(a) of: (1) claims 20-22 and 26-28 as
obvious over Lele '217, Lele '109, Cline, and Sherman; (2) claim 25 as
obvious over Lele '217, Lele '109, Cline, Sherman, and Crowley; (3) claim
23 as obvious over Lele '217, Lele '109, Cline, Sherman, and Chen; and
(4) claim 29 as obvious over Lele '217, Lele '109, Cline, Sherman, and Cox.
Claims 15-19
Appellants argue independent claim 15 recites limitations
substantially similar to those of claim 1, and that the rejections of claim 15
and its dependents are in error for the same reasons argued in support of
claim 1. App. Br. 12. We are not persuaded by Appellants' arguments.
Claim 15 recites "a temperature sensing element generating a signal
corresponding to a temperature of target tissue." Unlike claim 1 's "target
area," however, the "target tissue" in claim 15 is not specified to be located
at a predetermined distance from the wall of the lumen or from the housing.
Claim 15 recites an acoustic reflector "extending away from the housing in a
first direction by a first predetermined distance toward the target location so
that energy from the energy delivery element is focused away from the
energy delivery element in the first direction by a second predetermined
distance greater than the first predetermined distance" (emphasis added), but
the claim does not equate the tissue located at the second predetermined
distance to the "target tissue" recited in connection with the temperature
sensing element. Accordingly, Appellants' arguments regarding the
temperature sensing element in claim 1 do not apprise us of error in the
rejection of claim 15.
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Appellants also argue Cline does not teach "an acoustic reflector
positioned over an outer wall of the housing and extending away from the
housing in a first direction by a first predetermined distance toward the
target location so that energy from the energy delivery element is focused
away from the energy element in the first direction by a second
predetermined distance greater than the first predetermined distance" ("the
acoustic reflector limitation"), as recited in claim 15. See App. Br. 13
(arguing similar limitation in claim 1 ), 15 (arguing rejection of claim 15
should be overturned). According to Appellants, "Cline is not configured in
any way to focus the acoustic energy from the ultrasound transducers."
App. Br. 14. In arguing "Cline only describes altering a size of an area on
which energy is focused" (id.), however, Appellants acknowledge Cline
teaches focusing energy. To the extent Appellants argue the shape of the
transducer in Cline focuses the energy, claim 15 does not recite that only the
acoustic reflector focuses the energy. We agree with the Examiner (Ans. 17)
that Cline's teachings as to the effect of the refractor plate (see Cline col. 3,
11. 55---64) teach that it can change the direction of the sound waves towards
or away from normal, which changes the focal point. In addition, whether
the shape or diameter of the focal area is increased or decreased, Cline's
refraction plate 410 is involved in directing the energy to focal region 420,
which is located further from the transducer than the refraction plate. We
agree with the Examiner that Cline thus teaches the acoustic reflector
limitation of claim 15.
Accordingly, for the reasons discussed above and by the Examiner,
we are not apprised of error in the Examiner's rejection of claim 15 under
35 U.S.C. § 103(a) as unpatentable over Lele '217, Lele '109, Cline, and
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Sherman. Thus, we sustain the rejection of claim 15, and, for the same
reasons, the rejections of dependent claims 16-19, which Appellants argue
are in error for the same reasons as the rejection of claim 15 (App. Br. 15-
16). Specifically, we sustain the rejections of claims 16, 18, and 19 under 35
U.S.C. § 103(a) as obvious over Lele '217, Lele '109, Cline, and Sherman,
and claim 17 as obvious over Lele '217, Lele '109, Cline, Sherman, and
Crowley.
DECISION
We reverse the Examiner's decision to reject claims 1, 4, 5, 7-14, 20-
23, and 25-30. We affirm the Examiner's decision to reject claims 15-19.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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