Ex Parte BAKER et al

Patent Trial and Appeal Board

Jan 24, 2019

13160858 (P.T.A.B. Jan. 24, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/160,858 06/15/2011
151971 7590 01/28/2019
Forge IP, PLLC
1077 Bridgeport Ave
Suite 301
Shelton, CT 06484
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Peter Christensen BAKER
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.
06419-POOOlA 4199
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
01/28/2019 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):
patent@forge-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER CHRISTENSEN BAKER and RICHARD TREADWELL
Appeal2017-010030
Application 13/160,858 1
Technology Center 3700
Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
and system for delivery of high frequency acoustic energy to a target site in
a body cavity, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b ).
We reverse.
STATEMENT OF THE CASE
"Effective and long-lasting reduction of mucus and accumulated
inflammatory debris and reduction in the growth ofbiofilms within the nasal
passages, sinuses and their drainage systems, remain challenging despite the
1 Appellants identify the real party in interest as Otogenix, Inc. (Appeal Br.
2.)
Appeal2017-010030
Application 13/160,858
proliferation of treatment options." (Spec. 5.) "Nasal irrigators for
application of both solutions and aerosols are well known and are used to
relieve symptoms of sinusitis and rhinitis, such as nasal congestion." (Spec.
2.) "Application of ultrasound directly or indirectly to the nasal passages, or
to tissue in the nasal passages, has also been proposed." (Id. at 3.)
"The use of high intensity focused ultrasound (e.g., HIFU) is well
known for ablation or remodeling of various types of tissue." (Id. at 4.) In
some electro surgical systems, "[ w ]hen a high frequency voltage is applied,
tissue in proximity to the electrode is ablated, severed, or modified." (Id. at
4--5.) Appellants' invention is directed at "providing improved methods and
systems for delivery of fluids and aerosols and ultrasound energy to tissue
surfaces, cavities and obstructed sites in passages, lumens or cavities such as
nasal passages, sinuses and sinus ostia." (Id. at 5.)
Claims 1, 2, 5-8, 11-18, and 20-30 are on appeal. Claims 1 and 172
are representative and read as follows:
1. A system for delivery of high frequency acoustic energy to a target
site at a tissue or at an obstruction within a body cavity or lumen,
compnsmg:
an insertion wand sized and configured for insertion into a body
cavity or lumen;
an acoustic energy delivery member associated with the insertion
wand for contacting tissue and conveying high frequency acoustic energy
directly to the target site,
a distal end of the insertion wand having a plurality of ports, including
a fluid delivery port and an aspiration port, circumscribing a central portion
of the distal end; and
a fluid source that delivers fluid via the fluid delivery port to the target
site in a pulsatile flow,
2 We have added paragraphing for ease of reading.
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Appeal2017-010030
Application 13/160,858
wherein the acoustic energy delivery member includes a wire member
that delivers acoustic energy extendable from the central portion of the distal
end of the insertion wand to a position external to the insertion wand and
distal to the plurality of ports.
(Appeal Br. 16.)
17. A method for delivering high frequency acoustic energy to a target
site, comprising
positioning an insertion wand in proximity to the target site, a distal
end of the insertion wand having a plurality of ports, including a fluid
delivery port and an aspiration port,
circumscribing a central portion of the distal end; positioning an
acoustic energy delivery member associated with the insertion wand at the
target site in contact with tissue;
applying high frequency acoustic energy directly to the target site
through the acoustic energy delivery member; and
delivering fluid to the target site via the fluid delivery port using a
pulsatile flow, wherein the acoustic energy delivery member includes a wire
member that delivers high frequency acoustic energy and is extendible from
the central portion of the distal end of the insertion wand to a position
external to the insertion wand and distal to the plurality of ports, and
positioning the acoustic energy delivery member at the target site
includes extending the wire member from the insertion wand.
(Appeal Br. 18.)
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Application 13/160,858
The following grounds of rejection by the Examiner are before us on
review:
(1) Claims 1, 2, 7, 8, 11, 17, 18, 25-27, and 30 under 35 U.S.C.
§ I03(a) as unpatentable over Nita, 3 Deem, 4 Vaska, 5 and Haefner, 6
(2) Claims 12, 14, 15, and 28 under 35 U.S.C. § I03(a) as
unpatentable over Nita, Deem, Vaska, Haefner, and Coleman, 7
(3) Claims 5, 6, and 20-24 under 35 U.S.C. § I03(a) as
unpatentable over Nita, Deem, Vaska, Haefner, and Maguire, 8
(4) Claim 13 under 35 U.S.C. § I03(a) as unpatentable over
Nita, Deem, Vaska, Haefner, and Laugham, 9 and
(5) Claims 16 and 29 under 35 U.S.C. § I03(a) as unpatentable
over Nita, Deem, Vaska, Haefner, and Chang. 10
DISCUSSION
The Re} ection of Claims 1, 2, 7, 8, 11, 17, 18, 2 5-2 7, and 3 0
The Examiner finds that Nita teaches a system and method for
delivering acoustic energy to a target site within a body cavity, where the
system includes an insertion wand, and acoustic energy delivery member
associated with that wand for contacting tissue, a fluid delivery port, and a
3 Nita, US 2004/0024402 Al, published Feb. 5, 2004.
4 Deem et al., US 2007/0267011 Al, published Nov. 22, 2007. We note
that the Examiner incorrectly refers to this reference as "Deam." (See, e.g.,
Final Action 2.)
5 Vaska et al., US 2004/0054363 Al, published Mar. 18, 2004.
6 Haefner, US 2004/0204728 Al, published Oct. 14, 2004.
7 Coleman, US 6,692,450 Bl, issued Feb. 17, 2004.
8 Maguire et al., US 2002/0019627 Al, published Feb. 14, 2002.
9 Laugham, Jr. et al., US 2008/0031094 Al, published Feb. 7, 2008.
1° Chang et al., US 2006/0210605 Al, published Sept. 21, 2006.
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Application 13/160,858
fluid source that delivers fluid to the target site. (Final Action 2-3.) The
Examiner recognizes that Nita does not disclose that the acoustic energy
delivery member has a wire member that delivers the acoustic energy and is
extendable from the wand to a position external to the wand. (Id. at 3.) The
Examiner also recognizes that Nita does not disclose the wand having a
plurality of ports that circumscribe a central portion of the distal end of the
insertion wand and where the ports include an aspiration port. (Id.) The
Examiner contends that it would have been obvious to modify Nita to
include these structural limitations in light of the disclosure of Deem and
Haefner. (Id.)
The Examiner additionally notes that Nita does not explicitly disclose
that the acoustic energy is high frequency acoustic energy or that the fluid is
delivered using pulsatile flow. (Id.) The Examiner contends that it would
have been obvious to modify Nita to include these features in light of the
teachings of Deem and Vaska. (Id.)
The Examiner finds that Deem discloses using a wire member to
deliver acoustic energy into a nasal cavity and that this wire member is
extendable from within the central portion of the wand to a position external
thereto. (Id.) The Examiner further explains that Deem teaches that the
acoustic energy can be high frequency acoustic energy. (Id.) The Examiner
also finds that Deem discloses delivering fluid "by aerosol port which is a
pulsatile flow." (Id.) The Examiner finds that Vaska discloses delivering
fluid in a pulsatile flow and performs treatment with high frequency
ultrasound. (Id.) According to the Examiner, Vaska's disclosure supports
that "[p ]ulse fluid is effective in performing [a] flushing action." (Id. at 4.)
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Application 13/160,858
The Examiner finds that Haefner discloses a wand whose distal end
has "a plurality of ports, including an aspiration port, circumscribing a
central portion of the distal end." (Id. at 3.)
The Examiner reasons that the features disclosed in Deem, V aska, and
Heafner discussed above are "effective and commonly use[ d] in the field to
perform treatment and cleaning of tissue and body fluid/debris" and, thus, it
would have been obvious to modify Nita to include them. (Id. at 4.) The
Examiner explains that the addition of a guide wire to deliver the high
frequency acoustic energy that is extensible as claimed would have been
obvious to include because such a guide wire would more easily get inside a
body chamber to perform treatment. (Ans. 11-12.) The Examiner also
notes that the addition of many holes circumferentially at the distal end of
the wand would enable the device to deliver more dispersed fluid "to clean
more area." (Id. at 12.) According to the Examiner, adding these elements
to Nita would only require routine skill in the art and would have been added
"for the intuitively obvious reason mentioned." (Id.)
Regarding the "pulsatile flow," the Examiner states that "the cleaning
process utilizes water or fluid motion as ordinary artisans would instantly
recognize[, and] Vaska discloses fluid leaking/pouring out of the membrane
and onto the tissue." (Ans. 9.) According to the Examiner, "Vaska discloses
sweep away bubble or provide a flushing action" and "[i]f the bubble can be
swept away through the opening hole, then certainly debris or body
fluid/blood on the tissue can be swept away by fluid/water coming out of the
opening 462." (Id. at 9-10.) The Examiner asserts further that:
using pulsating fluid for flushing is common knowledge from
well-known everyday activities. For example, a clogged
kitchen sink can be unclogged by turning on water and using a
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Appeal2017-010030
Application 13/160,858
plunger to push the water down the drainage. This create a
pulsatile fluid that have strong pressure to sweep away the trash
that caused a clog in the drainage.
(Id. at 10.)
We disagree with the Examiner's conclusion that the system of claim
1 and the method of claim 17 would have been obvious from the prior art
relied on. As Appellants explain, Vaska' s disclosed use of pulsed flow that
results in a flushing action for the fluid or that "help[ s] to sweep away
bubbles" does not rely on the pulsed liquid per se to flush or sweep. (Appeal
Br. 7-8; Reply Br. 2-3; Vaska ,r 269.) Rather, the flushing/sweeping action
is the result of the pulsed flow of fluid "inflating/ deflating" a membrane.
(Id.)
While V aska teaches the pulsed fluid can be provided to cause the
fluid to intermittently leak through the membrane (Vaska ,r 269), in this
regard, Vaska teaches that such leaked fluid may help to conduct energy or
simply reduce or eliminate air gaps. Elimination of the air gap allows for
energy transfer from the ablation element to the tissue to be maximized for
most efficient treatment. (Vaska ,r,r 267-268.) As Vaska explains, air
bubbles can inhibit energy transfer and reduce the efficiency of ultrasound
and RF ablation. (See id. ,r 267). In short, contrary to the Examiner's
position, the pulsed flow of Vaska is not described to be such that it is
"pouring out"(Ans. 9) so as to sweep away anything of substance away
rather than just taking up space where air bubbles may have previously been.
Thus, we agree with Appellants that Vaska's teaching of pulsed flow does
not provide a motivation to deliver the fluid of Nita in a pulsed flushing
fashion to clean tissue/ debris.
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Application 13/160,858
Moreover, the Examiner's position that it is known that pulsating fluid
such as from a running faucet in a sink that is being plunged can clear away
debris (Ans. 10) is insufficient to establish a reason why one of ordinary
skill in the art would modify Nita to include pulsed flow. A prima facie case
for obviousness requires "a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007). That pulsed flow might clear away debris from a sink does not
explain why one of ordinary skill in the art would have modified Nita to
include pulsed flow. 11 As Appellants explain, Nita's system for therapeutic
ultrasound for ablating obstructions within blood vessels employs "reverse
irrigation, wherein the irrigation fluid is injected through a guide catheter
240, travels to the distal head of the catheter 10, and then carries the tissue
particles through the channel 74 in a reverse direction. (Appeal Br. 7; Nita ,r
57.) The Examiner has not explained why one of ordinary skill in the art
knowing that plunging a sink while running water thereby creating pulsed
flow would have provided a reason to one of ordinary skill in the art to use
pulsed flow of irrigation fluid in Nita's system, nor do we deem such a
reason to be "instantly recogniz[able]" as asserted by the Examiner (Ans. 9.)
11 We note that the Examiner contended that delivery of fluid by aerosol, as
taught by Deem "is a pulsatile flow." (Final Action 3.) The Examiner does
not point to any evidence in the record to support such a finding, and we
disagree with the Examiner's unsupported assertion. Aerosol sprays can
provide for a consistent flow rate. Moreover, we do not find Deem suggests
anywhere using aerosol application as a pulsatile flow. It simply describes
aerosol delivery as one means to have toxin delivered to a target tissue to
which acoustic energy may also be applied in order to achieve treatment
benefit by the toxin. (See, e.g., Deem ,r,r 30, 77, 125.)
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Application 13/160,858
In light of the foregoing, we disagree with the Examiner that one of
ordinary skill in the art would have found it obvious from the present record
to modify Nita to add pulsed flow of the fluid to the irrigation fluid delivery
described in Nita. Thus, we reverse the Examiner's rejection of claims 1, 2,
7, 8, 11, 17, 18, 25-27, and 30 under 35 U.S.C. § 103(a) as unpatentable
over Nita, Deem, Vaska, and Haefner.
The remaining rejections of the claims by the Examiner rely on the
Examiner's position concerning the obviousness of pulsed flow discussed
above. Thus, for the same reasons just discussed, we reverse the other
outstanding rejections of the claims by the Examiner.
SUMMARY
We reverse the rejection of claim 1, 2, 7, 8, 11, 17, 18, 25-27, and 30
under 35 U.S.C. § 103(a) as unpatentable over Nita, Deem, Vaska, and
Haefner.
We reverse the rejection of claims 12, 14, 15, and 28 under 35 U.S.C.
§ 103(a) as unpatentable over Nita, Deem, Vaska, Haefner, and Coleman.
We reverse the rejection of claims 5, 6, and 20-24 under 35 U.S.C. §
103(a) as unpatentable over Nita, Deem, Vaska, Haefner, and Maguire.
We reverse the rejection of claim 13 under 35 U.S.C. § 103(a) as
unpatentable over Nita, Deem, Vaska, Haefner, and Laugham.
We reverse the rejection of claims 16 and 29 under 35 U.S.C. § 103(a)
as unpatentable over Nita, Deem, Vaska, Haefner, and Chang.
REVERSED
9