Ex Parte Truckai et al

Patent Trial and Appeal Board

Oct 16, 2017

13267258 (P.T.A.B. Oct. 16, 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.
13/267,258 10/06/2011 Csaba Truckai 37646-714.201 8493
21971 7590 10/18/2017
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
EXAMINER
PORTER, JR, GARY A
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
10/18/2017 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):
patentdocket @ wsgr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CSABA TRUCKAI and AKOS TOTH1
Appeal 2016-008146
Application 13/267,258
Technology Center 3700
Before DONALD E. ADAMS, RYAN H. FLAX, and
DEVON ZASTROW NEWMAN Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method for performing endometrial ablation. Claims
20-26 and 28—33 are on appeal as rejected under 35 U.S.C. §§ 102 and 103.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as Minerva Surgical, Inc.
App. Br. 3.
Appeal 2016-008146
Application 13/267,258
STATEMENT OF THE CASE
The Specification states, “[t]he present invention relates to
electrosurgical methods and devices for global endometrial ablation in a
treatment of menorrhagia. More particularly, the present invention relates to
applying radio frequency current to endometrial tissue by means of
capacitively coupling the current through an expandable, thin-wall dielectric
member enclosing an ionized gas.” Spec. 12.
Claim 20 is the sole independent claim, is representative, and is
reproduced below:
20. A method for performing endometrial ablation
comprising:
trans-cervically introducing a probe working end into a
patient’s uterine cavity, the working end comprising an
expandable-contractible frame that carries a compliant energy-
delivery surface;
actuating the frame to expand the energy-delivery surface
in the uterine cavity;
actuating an inflation source to further expand the energy-
delivery surface in the uterine cavity; and
delivering energy from or through the energy-delivery
surface to cause endometrial ablation.
App. Br. 15 (Claims App’x).
The following rejections are on appeal:
Claims 20-26 and 30-33 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Truckai.2 Final Action 3.
2 US 2002/0022870 A1 (published Feb. 21, 2002) (“Truckai”).
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Application 13/267,258
Claims 26, 28, and 29 stand rejected under 35 U.S.C. § 103(a) over
Trackai and Stem.3 Id. at 6.
FINDINGS OF FACT
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the claims and prior art, and conclusions set out in the Final
Action and Examiner’s Answer. The findings of fact set forth below are
provided to highlight certain evidence.
FF1. Tmckai discloses “an apparatus and method of ablating
and/or coagulating tissue, such as that of the utems or other organ.”
Tmckai 111; see also Final Action 3—5, and Ans. 5—10 (discussing
Tmckai).
FF2. Tmckai discloses a “First Exemplary Embodiment—
Structure,” which is illustrated at, inter alia, Figures 1—10 and 20.
Tmckai 12—22, 31, 56—89; see also Final Action 3—5, and Ans. 5—10
(discussing Tmckai).
FF3. Tmckai discloses:
Electrode carrying means 12 is preferably a sack formed
of a material which is non-conductive, which is permeable to
moisture and/or which has a tendency to absorb moisture, and
which may be compressed to a smaller volume and
subsequently released to its natural size upon elimination of
compression. Examples of preferred materials for the electrode
carrying means include open cell sponge, foam, cotton, fabric, or
cotton-like material, or any other material having the desired
characteristics.
3 U.S. Patent 6,041,260 (issued Mar. 21, 2000) (“Stem”).
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Application 13/267,258
Truckai 166 (emphasis added); see also Final Action 3—5, and Ans. 5—10
(discussing Truckai). Truckai further discloses, “[ejlectrodes 14 are
preferably attached to the outer surface of the electrode carrying means
12, such as by deposition or other attachment mechanism.” Truckai 1 67;
see also Final Action 3—5, and Ans. 5—10 (discussing Truckai).
FF4. Further to the preceding findings of fact, Truckai’s
Figures 5 A, 10, and 20, reproduced below, illustrate structural features of
the First Exemplary Embodiment (Fig. 20 is reproduced in relevant
portion):
Figures 5A (above left), 10 (above center), and 20 (above right) show
alternative views of an ablation device having an electrode carrying means
12 mounted to the distal end of a shaft 10, with a sheath 32 thereover,
which “facilitates insertion of the apparatus into, and removal of the
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Application 13/267,258
apparatus from, the body organ to be ablated . . . such as into the uterus”
and into which the electrode carrying means 12 can be compressed and
which, when actuated to move proximally, releases the electrode carrying
means 12 and allows it to expand. Truckai 1 57, 79; see also Final Action
3—5, and Ans. 5—10 (discussing Truckai). Figure 5A illustrates “a front
elevation view of the applicator head and a portion of the main body of
the ablation device of FIG. 2, with the main body shown in cross-section,”
including an array of electrodes 14, which is a “compliant energy-delivery
surface” as claimed, across an electrode carrying means 12, which is an
expandable-contractible frame as claimed, shown as expanded.4 Truckai
16, 57, and 67—68; see also Final Action 3—5, and Ans. 5—10
(discussing Truckai). Figure 10 illustrates “a cross-section view of the RF
applicator head and the distal portion of the main body of the apparatus of
FIG. 1, showing the configuration of RF applicator head after the sheath
[32] has been retracted and the spring members [15, 19] have been
released into the fully opened condition,” which shows a way to expand or
further expand the frame/electrode carrying means 12. Truckai H 22, 81,
81, and 95; see also Final Action 3—5, and Ans. 5—10 (discussing
Truckai). Figure 20 illustrates “a side elevation view, similar to the view
of FIG. 2, showing an ablation device according to the present invention
4 Truckai’s “FIG. 2 is a front elevation view of the ablation device of FIG. 1,
with the handle shown in cross-section and with the RF applicator head in an
open condition” and “FIG. 1 is a front elevation view of a first embodiment
of an ablation device according to the present invention, with the handle
shown in cross-section and with the RF applicator head in a closed
condition.” Truckai ^fl[ 12, 13. Thus, figures purporting to illustrate the
device of Figures 1 and/or 2 show properties of the same structure.
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Application 13/267,258
in which the electrode carrying means [12] includes inflatable balloons
[52], For purposes of clarity, the electrodes [14] on the electrode carrying
means [12] are not shown.” Truckai H 31, 87; see also Final Action 3—5,
and Ans. 5—10 (discussing Truckai). This shows another way to expand
or further expand the frame/electrode carrying means 12.
FF5. Further to the preceding finding of fact, with regard to
the structure illustrated by Figure 10, Truckai discloses:
Because during use it is most desirable for the electrodes
14 on the surface of the electrode carrying means 12 to be held
in contact with the interior surface of the organ to be ablated, the
electrode carrying means 12 may be provide to have additional
components inside it that add structural integrity to the
electrode carrying means when it is deployed within the body.
Truckai 1 85 (emphasis added); see also Final Action 3—5, and Ans. 5—10
(discussing Truckai). This paragraph follows a detailed description of the
springs 15 and 19 and how they may be actuated to expand the electrode
carrying means 12. See Truckai ^fl[ 81—83. Thus, Truckai teaches that the
balloons 52, shown as expanding the electrode carrying means in Figure
10, can be an additional component relative to the springs 15 and 19 to
hold the electrode carrying means 12 in contact with the uterine tissue to
be ablated.
DISCUSSION
Only those arguments made by Appellants in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015).
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Anticipation
A patent claim is invalid for anticipation under 35 U.S.C. § 102 when
a prior art reference describes “each and every claim limitation and enable[s]
one of skill in the art to practice an embodiment of the claimed invention
without undue experimentation.” ClearValue, Inc. v. Pearl River Polymers,
Inc., 668 F.3d 1340, 1344 (Fed. Cir. 2012) (quoting Am. Calcar, Inc. v. Am.
Honda Motor Co., 651 F.3d 1318, 1341 (Fed. Cir. 2011)). “Anticipation
requires that all of the claim elements and their limitations are shown in a
single prior art reference.” In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir.
2009).
We find, in view of the above-identified precedent and findings of
fact, the Examiner has established that claim 20 is anticipated by Truckai.
For example, Truckai discloses: a method for performing endometrial
ablation (FF1); trans-cervically introducing a probe working end into a
patient’s uterine cavity (FF1, FF2), the working end comprising an
expandable-contractible frame (FF3) that carries a compliant energy-
delivery surface (FF3); actuating the frame to expand the energy-delivery
surface in the uterine cavity (FF4); actuating an inflation source to further
expand the energy-delivery surface in the uterine cavity (FF4, FF5); and
delivering energy from or through the energy-delivery surface to cause
endometrial ablation (FF1, FF3).
Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determination is incorrect. We address
Appellants’ arguments below.
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Appellants argue that the claimed “method requires both ‘actuating ...
[a] ... frame to expand ... [an] ... energy-delivery surface in the uterine
cavity’ and ‘actuating an inflation source to further expand the energy-
delivery surface in the uterine cavity.’” App. Br. 5. Pursuant to this
argument, Appellants contend that it is Truckai’s spring members 15 and 19,
and not Truckai’s electrode carrying member 12, that must be considered the
reference’s frame. See, e.g., id. at 6, 8. Further to this, Appellants contend
the inflatable balloons 52 disclosed by Truckai cannot be used with these
spring members 15 and 19, but can only be used as an alternative thereto.
Id. at 7—8, 10. Appellants also argue that, even if Truckai’s electrode
carrying means 12 can be considered to be a “self-expanding ‘frame,’” it is
not actuated by anything other than the balloon inflation in the respective
embodiment of the reference. Id. at 10. We do not find these arguments
persuasive.
First, we find the Examiner’s interpretation of the Truckai disclosure
with respect to disclosing a frame as the electrode carrying means 12 to be
reasonable. The Specification describes a frame as follows:
In a first aspect, the present invention provides systems for
endometrial ablation where the systems comprise a shaft with an
expandable-contractible frame mounted thereon. A compliant
energy-delivery surface is carried by the frame, and the surface
defines an interior chamber when expanded by the frame. The
frame is configured to engage the surface against an interior wall
or other portion of the patient’s uterine cavity when the working
end of the shaft is inserted into the cavity and the frame is
expanded. The exterior surface carries an electrode in order to
delivery energy into the uterine wall for ablation or other
therapeutic use.
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Spec. 1 6. This describes a structure within the scope of the claims and like
the electrode carrying means 12 of Truckai, which supports that the
Examiner’s understanding of Truckai’s structure is reasonable. Truckai
teaches that its electrode carrying means 12 expands when released from
compression, e.g., by withdrawing a sheath 32. FF3, FF4. This is expansion
of the electrode carrying means 12 by actuation.
Second, even if one must consider the springs 15 and 19 of Truckai to
be its frame, like that of the claimed method, we do not agree with
Appellants’ contention that Truckai’s balloons 52 cannot be used with such
springs 15 and 19 to further expand the electrode carrying means 12. The
balloons 52 are disclosed by Truckai as a potential addition to the structure
described therebefore in the reference, which includes the springs 15 and 19.
FF4, FF5. Truckai teaches that the purpose of providing such balloons 52 is
to include “additional components inside” the electrode carrying means 12,
which serve to “add structural integrity to the electrode carrying means when
it is deployed within the body” as it is “desirable for the electrode 14 on the
surface of the electrode carrying means 12 to be held in contact with the
interior surface of the organ to be ablated.” FF5. Thus, once the springs 15
and 19 are expanded to also expand the electrode carrying means 12 inside
the uterus, the balloons 52 can be inflated to ensure this desired contact with
the uterine tissue for ablation. Id. Therefore, under either the Examiner’s or
Appellants’ interpretation, Truckai anticipates claim 20.
For these reasons set forth above, we affirm the anticipation rejection.
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Obviousness
Appellants do no more than refer to their arguments over Truckai in
relation to anticipation, and further state that Stem does not cure the alleged
deficiencies of Tmckai with respect to independent claim 20, upon which
claims 26, 28, and 29 ultimately depend (see App. Br. 13). Having found no
deficiency in Tmckai, as it relates to Appellants’ claim 20, we are not
persuaded. Appellants provide no further comment with regard to the
combination of Tmckai and Stem as it relates to claims 26, 28, and 29.
Therefore, we affirm the obviousness rejection on this record.
SUMMARY
The rejection under 35 U.S.C. § 102(b) over Tmckai is affirmed.
The rejection under 35 U.S.C. § 103(a) over Tmckai and Stem is
affirmed
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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