Ex Parte Bloom et al

Patent Trial and Appeal Board

Jun 12, 2017

13250104 (P.T.A.B. Jun. 12, 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.
13/250,104 09/30/2011 Eliot F. Bloom C00002718.USU 1 6831
(21819E-42
89554 7590 06/14/2017
Christopher & Weisberg, P.A.
200 East Las Olas Boulevard
Suite 2040
Fort Lauderdale, EL 33301
EXAMINER
STICE, PAULA J
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
06/14/2017 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):
ptomail @ c wiplaw. com
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ELIOT F. BLOOM, VACLAV O. POD ANY,
CHAD M. GREENLAW, and BRIAN M. CONLEY
Appeal 2016-004374
Application 13/250,1041
Technology Center 3700
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 1—20 and 22—27
(App. Br. 1). Examiner entered rejections under 35 U.S.C. § 112, second
paragraph and 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM-IN-PART.
STATEMENT OF THE CASE
Appellants’ disclosure “relates to medical devices, particularly to an
electrosurgical balloon having one or more electrodes disposed on an
exterior surface of the balloon, and a bipolar electrode configuration in
1 Appellants identify the real party in interest as “Medtronic Advanced
Energy LLC” (App. Br. 3).
Appeal 2016-004374
Application 13/250,104
which a pair of bipolar electrodes are disposed on an exterior surface of the
balloon” (Spec. 11). Claims 1, 2, 20, 24, and 27 are representative and
reproduced below:
1. A catheter assembly, comprising:
a catheter including an elongated body having a distal
end portion; and
a balloon electrode tip attached to the distal end portion
of the catheter, the balloon electrode tip including:
an inflatable balloon body formed of a non-conductive
substrate material, the inflatable balloon including a proximal
end, a distal end, a longitudinal length there between, and a pair
of bipolar electrodes disposed on an exterior surface of the
balloon body, the pair of electrodes including a first electrode
and a second electrode extending to substantially the same
longitudinal length proximate the distal end of the inflatable
balloon in a bipolar electrode configuration, at least a portion of
the first electrode and the second electrode being insulated
proximal to the respective distal ends of each the first electrode
and the second electrode, and
at least one fluid outlet hole in the inflatable balloon
body configured to provide a fluid from a fluid source to the
pair of bipolar electrodes.
(App. Br. 16.)
2. A catheter assembly, comprising:
a first catheter including an elongated body having a
distal end portion; and
a balloon electrode tip attached to the distal end portion
of the first catheter, the balloon electrode tip including:
a first inflatable balloon body formed of a non-
conductive substrate material, the first inflatable balloon
including a proximal end and a distal end, and a pair of bipolar
electrodes disposed on an exterior surface of the first inflatable
balloon body, the pair of electrodes including a first electrode
and a second electrode in a bipolar electrode configuration and
2
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Application 13/250,104
disposed at the distal end of the first inflatable balloon, at least
one fluid outlet hole in the balloon body configures to provide a
fluid from a fluid source to the pair of bipolar electrodes; and
a second catheter including a second elongated body
having a second distal end portion and a lumen, wherein the
first catheter is disposed within the lumen.
(App. Br. 16—17.)
20. A catheter assembly, comprising:
a first catheter including a first elongated body having a
first distal end portion;
a second catheter including a second elongated body
having a second distal end portion and a lumen, wherein the
first catheter is disposed within the lumen; and
a balloon electrode tip attached to the first distal end
portion, the balloon electrode tip including:
an outer inflatable balloon body formed of a non-
conductive substrate material,
an inner inflatable balloon body disposed inside the outer
inflatable balloon body, and
a first electrode and a second electrode disposed on an
exterior surface of the outer balloon body, the first electrode
and the second electrode being disposed at the distal end of the
outer inflatable balloon body.
(App. Br. 20.)
24. An electro surgical balloon, comprising:
an inflatable balloon body having a proximal end and a
distal end and defining a circumference, wherein the balloon
body is formed of a nonconductive substrate material;
a pair of bipolar electrodes disposed on an opposite sides
of an exterior surface of the inflatable balloon body, the pair of
electrodes including a first electrode and a second electrode in a
bipolar electrode configuration, each the first electrode and the
second electrode extending partially around the circumference
of the inflatable balloon body ; and
3
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Application 13/250,104
at least one fluid outlet hole in the balloon body
configured to provide a conductive fluid from a fluid source to
the pair of bipolar electrodes.
(App. Br. 21.)
27. A method for treating tissue using electrical energy,
comprising:
providing radio-frequency energy to a bipolar balloon
electrode tip attached to a distal end portion of a catheter, the
balloon electrode tip includes a balloon body inflatable with a
conductive fluid and having a pair of bipolar electrodes
disposed on an exterior surface of the balloon body and at the
distal end of the balloon body, the balloon body being formed
of a nonconductive substrate material;
contacting targeted tissue with the energized bipolar
balloon electrode tip; and discharging a portion of the
conductive fluid from a fluid outlet hole in the balloon body to
electrically couple the pair of electrodes disposed on an exterior
surface of the balloon body, wherein the fluid provides a
conductive pathway for energy to flow between the pair of
electrodes.
(App. Br. 22.)
The claims stand rejected as follows:
Claims 1 and 12—19 stand rejected under 35U.S.C. § 112, second
paragraph (Ans. 2).
Claims 1, 2, 9—16, and 27 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Laufer2 and Starkebaum3 (id. ).
2 Laufer et al., US 6,283,989 Bl, issued Sept. 4, 2001.
3 Starkebaum et al., US 7,252,665 B2, issued Aug. 7, 2007.
4
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Application 13/250,104
Claim 17 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Laufer, Starkebaum, and Ingle4 (id. ).
Claims 3—8 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Laufer, Starkebaum, and Kramer5 (id. ).
Claims 18 and 19 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Laufer, Starkebaum, and Rioux6 (id. at
3).
Claims 20 and 22—26 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Laufer and Kramer (id. at 2).
Definiteness'.
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that Appellants’ claims 1 and 12—19 are indefinite?
ANALYSIS
The catheter assembly of Appellants’ claim 1 requires, inter alia, a
“pair of electrodes including a first electrode and a second electrode
extending to substantially the same longitudinal length proximate the distal
end of the inflatable balloon in a bipolar electrode configuration” (App. Br.
16 (emphasis added)).
According to Examiner, “the use of the word substantially renders the
claim indefinite in that the metes and bounds of the word substantially
cannot be determined from the claim language or [Appellants’]
4 Ingle et al., US 6,091,995, issued July 18, 2000.
5 Kramer, US 2002/0045892 Al, published Apr. 18, 2002.
6 Rioux et al., US 2009/0054892 Al, published Feb. 26, 2009.
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Appeal 2016-004374
Application 13/250,104
[Specification” (Final Act.7 2; see Ans. 3—4). We are not persuaded.
Instead, we agree with Appellants that, when Appellants’ claimed invention
is read in light of Appellants’ Specification, “[i]t is clear . . . that the phrase
‘substantially the same’ means that the plurality of the electrodes extends to
substantially the same length on the balloon ‘proximate the distal end of the
inflatable balloon in a bipolar electrode configuration’” (App. Br. 8
(emphasis added); see Reply Br. 4—6). In re Miller, 441 F.2d 689, 693
(CCPA 1971) (“breadth is not to be equated with indefmiteness”).
CONCLUSION OF LAW
The preponderance of evidence fails to support Examiner’s conclusion
that Appellants’ claims 1 and 12—19 are indefinite. The rejection of claims 1
and 12—19 under 35 U.S.C. § 112, second paragraph is reversed.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
7 Examiner’s July 14, 2015 Final Office Action.
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Application 13/250,104
FACTUAL FINDINGS (FF)
FF 1. Examiner’s annotation of Laufer’s Figure IB is reproduced below:
Laufer’s FIG. IB illustrates “an embodiment of [Laufer’s] heat treatment
apparatus [] which employs electrodes [102 and 104] positioned on the outer
surface of a balloon []” (Laufer 3: 48—50). Examiner annotates Laufer’s
FIG. IB to identify the distal end, intermediate region and proximal end of
Laufer’s balloon, the distal end of each electrode, and that Laufer discloses
that the “balloon can [] be made of elastic material such as silicone, natural
latex, and polyethylene” (see Ans. 6; Laufer 4: 45—47).
FF 2. Examiner finds that Laufer’s balloon is “insulative, [as] it is
disclosed as consisting of materials such as silicone, latex and polyethylene,
all of which are well known in the art to be insulators and not conductors”
(Ans. 4—5).
FF 3. Examiner finds that “[i]n the design of Laufer the electrodes are the
metal strips, 102/104 which are connected via wires 142/122; the current
would radiate from this strip in all directions; the balloon holds the
electrodes in place and also insulates the current from traveling into the
balloon” (Ans. 5; see id. at 4 (Appellants’ claims “do[] not specify that the
first and second electrodes are coveredthus, Laufer reads on Appellants’
claimed invention, wherein Laufer’s balloon, which is made of an insulating
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Application 13/250,104
material, “inherently [insulates] . . . the electrodes ... on their bottom side
which abuts the balloon surface, [where] they are insulated by the balloon
itself’))
FF 4. Examiner finds that Appellants’ claims, when read in light of
Appellants’ Specification, do not define the precise degree of the word
“substantially” and, therefore, the position of Laufer’s electrodes read on the
requirement in Appellants’ claims that a “pair of electrodes including a first
electrode and a second electrode extend[] to substantially the same
longitudinal length proximate the distal end of the inflatable balloon in a
bipolar electrode configuration” (Ans. 5—6; App. Br. 16).
FF 5. Examiner finds that “Laufer does not specifically disclose fluid
outlet holes in the body of the balloon [] configured to provide fluid from a
fluid source to the electrodes, and that the fluid outlet holes are between the
electrodes to establish an electrically conductive pathway between the
electrodes,” and relies on Starkebaum to make up for this deficiency in
Laufer (Non-Final Act.8 7).
FF 6. Appellants disclose:
The one or more electrodes can be formed of any suitable
material. For example, the electrode(s) can be a biocompatible
conductive wire [] adhered to the exterior surface of the
balloon, or the electrode(s) can be formed of a conductive ink
applied [] to the surface of the balloon substrate material. The
wire or conductive ink electrode(s) on the balloon’s surface can
include an exposed electrode portion [] and a lead portion [].
The electrode lead portion can be soldered to a distal end
portion of the catheter lead wires(s). The soldered connections
and the electrode lead portion can be insulated (e.g., using an
8 Examiner’s March 31, 2015 Non-Final Office Action.
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Appeal 2016-004374
Application 13/250,104
insulative material [] deposited over a conductive ink electrode,
or using an insulative sheath on a wire electrode).
(Spec. 127 (emphasis added); id. 146 (“In the embodiment shown in FIGs
1, 2, 3A and 3B, bipolar electrodes [] include respective exposed, conductive
electrode portions [] and respective lead portions [], whose exterior surfaces
have been covered by an insulative material []”); see id. 131 (“[t]he
electrodes are separated from each other on the balloon’s exterior surface,
and are insulated from each other by the separation area formed by the non-
conductive balloon substrate materiaF) (emphasis added)).
FF 7. Appellants’ Figure 10 is reproduced below:
I20e
130 122"
124
FIG, 10
Appellants’ FIG. 10 illustrates
156b'
l
156a'
! I DO a *
156b’ 156a'
a balloon electrode tip 120e [that] includes a pair of bipolar
electrodes 156a’ and 156b’ provided on exterior surface 124 of
a balloon body 122”. Balloon body 122” has a cylindrical
central portion extending to a conically-shaped distal end
portion. Bipolar electrodes 156a’ and 156b’ extend helically
around these cylindrical and conical portions of balloon body
122”
(Spec. 166.)
FF 8. Examiner finds that “Laufer does not specifically disclose the use of
an inner and outer balloon with a fluid outlet to provide fluid from fluid
source to the electrodes” and relies on Kramer to make up for this deficiency
in Laufer (Non-Final Act. 11).
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Application 13/250,104
ANALYSIS
The rejections over the combination of Laufer and Starkebaum, with or
without Ingle, Kramer, or Rioux:
Based on the combination of Laufer and Starkebaum, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious “to modify Laufer to include fluid outlets within
the balloon wall to create a conductive pathway, as taught by Starkebaum, in
order to have a larger surface area electrode for ablative effects” (Non-Final
Act. 7).
Claim T.
We agree with Examiner’s finding that Appellants’ claims do not
require the electrodes to be “covered,” therefore, we are not persuaded by
Appellants’ contention that “[i]t is clear from [claim 1] and [Appellants’]
[Specification, that the first and second electrodes are covered by an
insulator, rather than sitting on top of a non-conductive element” (see FF 3;
see also FF 6, citing Spec. 131 (wherein Appellants disclose that by
separating the electrodes from each other on the balloon’s exterior surface,
at least a portion of the first and second electrodes are insulated proximal to
the respective distal ends of each of the first and second electrodes by the
non-conductive balloon substrate material (emphasis added)); cf App. Br.
9; Reply Br. 6 (Appellants “argued in [their] brief that Faufer’s balloon itself
cannot be characterized as insulating any electrodes”); Reply Br. 8 (“an
exposed wire on the face of a balloon cannot reasonably be characterized as
being insulated” (emphasis removed))).
We agree with Examiner’s finding that Faufer’s balloon is composed
of insulating materials and, therefore, are not persuaded by Appellants’
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Application 13/250,104
contentions regarding balloons that may comprise conductive materials (see
FF 2; cf. App. Br. 9-10; Reply Br. 6—7). For the foregoing reasons, we are
not persuaded by Appellants’ contention that Examiner’s interpretation of
their claimed invention renders the term “‘insulated’ . . . meaningless”
(Reply Br. 7; see FF 6).
We agree with Examiner’s finding that Appellants’ claims, when read
in light of Appellants’ Specification, do not define the precise degree of the
word “substantially.” (FF 4.) Appellants’ figure 10, which demonstrates an
embodiment of the invention (Spec. 1 66), provides for spaced apart
helically wound electrodes that terminate at different positions along the
length of the inflatable balloon. (FF 7.) We agree with the Examiner
therefore, that the position of Laufer’s electrodes read on the requirement in
Appellants’ claims that a “pair of electrodes including a first electrode and a
second electrode extend[] to substantially the same longitudinal length ... of
the inflatable ballooon.” Furthermore, Appellants fail to provide persuasive
evidence or argument to support a conclusion that Examiner’s
characterization of the distal end of Laufer’s balloon is incorrect (see FF 1;
Ans. 5—6; cf. App. Br. 10; Reply Br. 8—9). The claims do not recite that the
electrodes are at the end of the distal portion of the balloon. Rather the
claims require that the pair of electrodes are proximate the distal end of the
inflatable balloon. “Distal end” is not defined in the Specification. It is
used, however, consistently throughout to refer to a region, with reference to
a position along a particular element, that is situated away from a point of
origin. (See, e.g., Spec 126: “The balloon can be disposed at a distal end of
an elongated medical device,” “Catheter lead wire(s) that can be connected
to a power source at a proximal end of the catheter are carried by the
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Application 13/250,104
catheter to the catheter’s distal end to connect with the electrode(s).”; 127:
“The electrode lead portion can be soldered to a distal end portion of the
catheter lead wire(s).”; 128: “The balloon can have a double diameter (with
a smaller diameter proximal end and a larger diameter distal end)”.) There
is nothing in the claims or Appellants’ Specification that requires defining
the point of origin for the point of reference for the “distal end” at, for
example, the center of the object of concern. The Examiner has determined
the reference point for distal end of the balloon on Laufer is the transition at
which the full inflated circumference begins. We do not disagree with the
Examiner’s finding in light of the foregoing discussion concerning the term
“distal end.” Thus, we also agree with the Examiner that the position of
Laufer’s electrodes read on the requirement in Appellants’ claims that the
“pair of electrodes . .. extend[] to substantially the same longitudinal length
proximate the distal end of the inflatable balloon in a bipolar electrode
configuration.” Indeed the pair of electrodes of Laufer are at the distal end
of the inflatable balloon.
For the foregoing reasons we are not persuaded by Appellants’
contention that “Laufer fails to disclose any electrodes proximate the distal
end of its balloon, let alone a pair of electrodes” or that “Laufer’s electrodes
are not disposed at the substantially the same longitudinal length as defined
by [Appellants]” (App. Br. 10—11; Reply Br. 8—9; cf FF 7).
We recognize Appellants’ dictionary citation of the term “insulate”,
which appears to be newly presented evidence on this record (Reply Br. 7).
Nevertheless, we are not persuaded by Appellants’ contention that a person
of ordinary skill in this art would limit the scope of the term “insulate” to the
single meaning Appellants’ selected: “to cover” (id.; cf FF 6).
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Application 13/250,104
Claims 2 and 27\
Appellants fail to provide persuasive evidence or argument to support
a conclusion that Examiner’s characterization of the distal end of Laufer’s
balloon is incorrect (see FF 1; Ans. 7; cf. App. Br. 11; Reply Br. 9-10; FF
7). Therefore, we are not persuaded by Appellants’ contention that “no
matter how broadly the Examiner reasonably construes the term ‘distal end,’
such a feature is undoubtedly not disclosed by Faufer, which discloses that
neither of its electrodes are at the distal end of its balloon” (App. Br. 11; see
generally id. at 12; Reply Br. 9—10).
Claim 17:
Having found no error in the combination of Faufer and Starkebaum,
we are not persuaded by Appellants’ intimation that Ingle fails to make up
for an alleged deficiency in the combination of Faufer and Starkebaum
(App. Br. 12; see Reply Br. 10). Therefore, we are not persuaded by
Appellants’ contention that “Claim 17 is believed allowable as it depends
from Claim 1, which is believed allowable” (App. Br. 12; see Reply Br. 10).
Claim 3:
Having found no error in the combination of Faufer and Starkebaum,
we are not persuaded by Appellants’ intimation that Kramer fails to make up
for an alleged deficiency in the combination of Faufer and Starkebaum
(App. Br. 12; Reply Br. 10). Therefore, we are not persuaded by
Appellants’ contention that “Claim[] [3 is] believed allowable as [it]
depends from [] Claim 2, which is believed allowable” (App. Br. 12; Reply
Br. 10).
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Application 13/250,104
Claim 18:
Having found no error in the combination of Laufer and Starkebaum,
we are not persuaded by Appellants’ intimation that Rioux fails to make up
for an alleged deficiency in the combination of Laufer and Starkebaum
(App. Br. 13; Reply Br. 11). Therefore, we are not persuaded by
Appellants’ contention that “Claim[] [18 is] believed allowable as [it]
depends from Claim 1, which is believed allowable” (App. Br. 13; Reply Br.
11).
The rejection over the combination of Laufer and Kramer.
Based on the combination of Laufer and Kramer, Examiner concludes
that, at the time Appellants’ invention was made, it would have been prima
facie obvious “to modify Laufer to include a dual balloon design, as taught
by Kramer, which [h]as an exterior and interior balloon which are inflated
with a fluid and coupled to the interior catheter, in order to have a structure
which has a weeping exterior balloon []” (Non-Final Act. 11).
Appellants contend that:
Claim 20 recites, in part, “first electrode and a second electrode
disposed on an exterior surface of the outer balloon body, the
first electrode and the second electrode being disposed at the
distal end of the outer inflatable balloon body.” As discussed
above with respect to Claims 2 and 27, Laufer fails to disclose
any such feature. Moreover, Kramer fails to disclose any such
feature.
(App. Br. 11; Reply Br. 11.) For the reasons set forth above, with respect to
Claims 2 and 27, we are not persuaded.
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Application 13/250,104
Claims 24—26\
The electrosurgical balloon of Appellants’ claim 24 requires, inter
alia, that “each [of] the first electrode and the second electrode extend[s]
partially around the circumference of the inflatable balloon body” (App. Br.
21). Appellants’ claims 25—26 depend directly or indirectly from
Appellants’ claim 24 (id. at 22).
Notwithstanding Examiner’s assertion to the contrary, we agree with
Appellants’ contention that Laufer’s “electrodes [] completely surround, and
in fact, overlaps itself around its balloon” and, “[t]hus, these electrodes do
not extend ‘partially’ around the balloon” (App. Br. 13; see generally Reply
Br. 11; cf. Ans. 7).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to Appellants’ claims 1, 2, 3, 17, 18,
20, and 27.
The rejection of claims 1, 2, and 27 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Laufer and Starkebaum is affirmed.
Claims 9-16 are not separately argued and fall with claims 1 and 2,
respectively.
The rejection of claim 17 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Laufer, Starkebaum, and Ingle is affirmed.
The rejection of claim 3 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Laufer, Starkebaum, and Kramer is affirmed.
Claims 4—8 are not separately argued and fall with claim 3.
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The rejection of claim 18 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Laufer, Starkebaum, and Rioux is affirmed. Claim
19 is not separately argued and falls with claim 18.
The rejection of claim 20 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Laufer and Kramer is affirmed. The rejection of
claims 22 and 23 are not separately argued and fall with claim 20.
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness with respect to the rejection of claims
24—26.
The rejection of claims 24—26 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Laufer and Kramer is reversed.
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-IN-PART
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