Ex Parte Golan

Patent Trial and Appeal Board

Jan 23, 2017

13055507 (P.T.A.B. Jan. 23, 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.
13/055,507 01/24/2011 Erez Golan 1926GOL-US 6062
32964 7590 01/23/2017
DEKEL PATENT LTD., DAVID KLEIN
BEIT HAROF'IM
18 MENUHA VENAHALA STREET, ROOM 27
REHOVOT, 76209
ISRAEL
EXAMINER
TANNER, JOCELIN C
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
01/23/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EREZ GOLAN
Appeal 2014-009091
Application 13/055,507
Technology Center 3700
Before LINDA E. HORNER, THOMAS F. SMEGAL, and LISA M. GUIJT,
Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134 of the Examiner’s
decision2 rejecting claims 1-14 and 16—22. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
CLAIMED SUBJECT MATTER
Claims 1 and 22 are independent. Claim 1 is reproduced below.
1 Appellant identifies the real party in interest as Pi-R-Squared Ltd. Br. 1.
2 Appeal is taken from the Final Office Action dated February 6, 2013
(“Final Act.”).
Appeal 2014-009091
Application 13/055,507
1. A device for fracturing calcifications in heart valves
comprising:
an impactor catheter configured for percutaneous delivery
to a heart valve;
an impact-producing element disposed at a distal portion
of said catheter and operative to vibrate and create a mechanical
impact when deployed out of an external housing of said catheter
and brought into contact with a calcification at a leaflet of said
heart valve;
an energy source operative to vibrate said vibrating
impact-producing element so that said impact-producing element
fractures the calcification without necessarily removing the
calcification from the leaflet; and
an anvil against which the calcification is struck by said
impact-producing element.
REJECTIONS
I. Claims 1,3,4, and 22 stand rejected under 35 U.S.C. § 102(b)
as anticipated by Kassab (US 2010/0198211 Al; pub. Aug. 5, 2010).
II. Claims 1, 4, 5, 13,21, and 22 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Pedersen (US 2005/0075662 Al; pub. Apr. 7,
2005).
III. Claim 2 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Pedersen and Brisken (US 5,846,218; iss. Dec. 8, 1998).
IV. Claims 6 and 20 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Pedersen and Zadno-Azizi (US 6,022,336; iss. Feb. 8,
2000).
V. Claim 8 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Pedersen and Evans (US 5,916,229; iss. June 29, 1999).
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VI. Claim 9 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Pedersen and Salahieh ’696 (US 2005/0137696 Al; pub.
June 23, 2005).
VII. Claim 14 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Pedersen and Salahieh ’872 (US 2006/0058872 Al; pub.
Mar. 16, 2006).
VIII. Claims 16 and 18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Pedersen, Salahieh ’696, and Galdonik (US 2005/0085847
Al; pub. Apr. 21, 2005).
IX. Claims 17 and 19 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Pedersen, Salahaieh ’696, and Leone (US 2006/0253148
Al; pub. Nov. 9, 2006).
X. Claims 1,2, and 21 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Zadno-Azizi and Brisken.
XI. Claim 11 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Zadno-Azizi, Brisken, Saadat (US 5,827,269; iss. Oct. 27,
1998) and Hong (US 2002/0125842 Al; pub. Sept. 12, 2002).
XII. Claims 1, 4, and 7 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Noriega (US 2005/0228418 Al; pub. Oct. 13, 2005) and
Shturman (US 5,295,958; iss. Mar. 22, 1994).
XIII. Claims 1 and 10 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Gifford (US 2006/0229659 Al; pub. Oct. 12, 2006) and
Shturman.
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XIV. Claims 1, 4, 21, and 22 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Lemelson (US 5,728,123; iss. Mar. 17, 1998) and Lary
(US 5,649,941; iss. July 22, 1997).
ANALYSIS
Rejection I
Independent claim 1 and dependent claim 3 and 4
Regarding independent claim 1, the Examiner finds, inter alia, that
Kassab’s first and second umbrellas 102, 104 correspond to the claimed
impact-producing element, and Kassab’s drill 114 corresponds to the
claimed anvil. Final Act. 2. The Examiner determines that Kassab discloses
that “the calcification is stmck by the impact-producing element” (umbrella
102 or 104) against the anvil (drill 114). Id. (citing Kassab H 48—50). The
Examiner further determines that “[i]f the prior art structure is capable of
performing the intended use, then it meets the claim,” and that here, Kassab
discloses “an impact-producing element. . . capable of being opened and
closed repeatedly against the anvil having the form of a drill and generating
vibration.” Ans. 16. Appellant argues that Kassab’s drill 114 is not an anvil
and is not capable of being used as an anvil. Br. 25 (citing Kassab 151).
The Examiner has not directed us to, nor can we find, support in
Kassab that drill 114 is an anvil against which something, such as a calcified
aortic valve, is being struck.3 4Rather, Kassab consistently discloses that
3 Appellant submits that the claim term “anvil” means “a structure against
which something is hit by an impactor.” Br. 31.
4
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“[d]rill 114 may comprise one or more blades operable to grind, for
example, a calcified aortic valve,” [and] “allow for the pulverization of the
calcific calcium material at the level of the aortic leaflet.” Id. 1 51; see also,
e.g., 1 59 (“drill 612 may be operated to grind (or chop) cauterized calcified
aortic valve 608 into small pieces”). Kassab discloses
[rotatably coupling the] mechanical drill ... to the shaft [of a]
catheter . . . between the first umbrella and the second umbrella,
positioning the umbrella device within an aperture within the
valve, deploying the first umbrella on a first side of the valve,
wherein the deployed first umbrella engages the valve at the first
side of the valve, deploying the second umbrella on the second
side of the valve, wherein the deployed second umbrella engages
the valve at the second side of the valve, operating the
mechanical drill to grind the valve, collapsing the first umbrella
and the second umbrella to facilitate withdrawal of the umbrella
device from the vessel, and withdrawing the umbrella device
from the vessel.
Id. 113 (emphasis added). Alternatively, the umbrellas may include
cauterizing wires on their circumferential edges “to excise the valve from the
vessel prior to the step of operating the mechanical drill to grind the valve.”
Id.
Moreover, the Examiner fails to provide a reason tethered to, or
grounded in, some rationale to believe that the blades of Kassab’s drill are
capable of functioning as an anvil against which the calcified aortic valve is
struck by repeatedly opening and closing the umbrellas when the umbrellas
are deployed and brought into contact with a calcification at a leaflet of the
heart valve, as required by claim 1. “[WJhere the Patent Office has reason to
believe that a functional limitation asserted to be critical for establishing
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novelty in the claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to require the
applicant to prove that the subject matter shown to be in the prior art does
not possess the characteristic relied on.” In re Swinehart, 439 F.2d 210, 213
(CCPA 1971). Nevertheless, the examiner must establish a sound basis for
the examiner’s belief that the functional limitation is an inherent
characteristic of the prior art before the burden shifts to the applicant. See In
re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
Accordingly, we do not sustain the Examiner’s rejection of
independent claim 1, and claims 3 and 4 depending therefrom under 35
U.S.C. § 102(b) as anticipated by Kassab.
Independent claim 22
Regarding independent claim 22, Appellant argues that, with respect
to Kassab’s umbrellas, “there is only one single opening or one single
closing — not cyclical movement, so there is no teaching of vibration.” Br.
26.
Kassab describes deploying and collapsing the umbrellas for
facilitating insertion and removal of the device, and for engaging and
cauterizing the valve, as discussed supra. See, e.g., Kassab 113. Kassab
also discloses that “first umbrella 604 and second umbrella 606 may
comprise magnetic material so that [the umbrellas] may be magnetically
attracted to shaft 614 . . . [and] may collapse inwards to shaft 614, exerting
an inward force to further crush the calcified debris and close [the
umbrellas].” Kassab 161. However, as stated supra, we agree with
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Appellant that the Examiner fails to provide an adequate reason to believe
that Kassab’s umbrellas are capable of being vibrated so as to fracture
calcifications “when [the umbrellas are] deployed . . . and brought into
contact with a calcification at a leaflet of said heart valve,” as required by
claim 22.
Accordingly, we do not sustain the Examiner’s rejection of claim 22
under 35 U.S.C. § 102(b) as anticipated by Kassab.
Rejection II
Regarding independent claims 1 and 22, the Examiner finds, inter
alia, that Pedersen’s catheter balloon 376 corresponds to the claimed anvil,
and that Pedersen’s expandable anchoring petals 374 correspond to the
claimed impact-producing element. Final Act. 3 (see, e.g., Pedersen 1134
(“Petal Anchoring Catheter”; Figs. 14A, 14B). The Examiner also finds that
Pedersen discloses that the Petal Anchoring Catheter embodiment may be
used as a fixed platform. Ans. 16. The Examiner further finds that
Pedersen’s “Mesh Anchoring Ring” embodiment discloses a high energy
low frequency ultrasound energy source, “which is well known to be capable
of vibrating such that the impact-producing element fractures the
calcifications without necessarily removing the calcification from the
leaflet.” Final Act. 4 (citing Pedersen 1147; Fig. 23; see also 1143). The
Examiner reasons that it would have been obvious “to have provided the
balloon catheter [(depicted in Figure 14B of Pedersen)] with an energy
source, as taught by Pedersen, to deliver and position high energy sources to
debulk valve leaflets.” Id. The Examiner concludes that using Pedersen’s
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Petal Anchoring Catheter as a fixed platform to deliver and position
ultrasound for debulking valve leaflets would result in “oscillating
movement of the catheter” and therefore, the “balloon and petals would
provide vibration.” Ans. 16.
Appellant argues that Pedersen does not teach “an energy source
operative to vibrate said vibrating impact-producing element so that said
impact-producing element fractures the calcification,” as required by claims
1 and 22. Br. 27. In support, Appellant submits that, with respect to the
ultrasound energy, “Pedersen teaches [using] the catheter to deliver an
energy source,” including an ultrasound energy source, but to rely on such a
disclosure for teaching the use of the energy source to vibrate Pedersen’s
expandable anchoring petals 374 to fracture calcifications is to engage in
impermissible hindsight. Id.
Figures 14A and 14B depict an embodiment titled, “Petal Anchoring
Catheter,” wherein expandable anchoring petals 374 expand against aortic
root walls to “stabilize and prevent movement of the petal anchoring catheter
370 before and during balloon inflation.” Pedersen || 134, 135. Pedersen
explains that
[i]n operation, the petal anchoring catheter 370 is positioned so
that the catheter balloon 376 passes through the aortic valve.
Next, the anchoring petals 374 are deployed, engaging the aortic
root wall 123 and the inferior recesses of the aortic sinuses near
the annulus 125, preventing the petal anchoring catheter 370
from longitudinal movement. Finally, the catheter balloon 376
is inflated so as to push open the valve leaflets 126. The catheter
balloon 376 is then deflated but may be inflated multiple times
to achieve a desired leaflet flexibility and pressure gradient
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reduction. When this has been achieved, the anchoring petals
374 are retracted and the petal anchoring catheter 370 is removed
from the patient.
Id. 1139. Pedersen does not disclose vibrating anchoring petals 374, which
anchor the catheter, or an energy source operative to vibrate anchoring petals
374. Pedersen discloses that “the petal anchoring catheter 360 and 370 may
be used as a fixed platform on which prosthetic implants can be delivered to
and deployed on the aortic valve.” Pedersen 1142.
Figures 23 A—C of Pedersen depict an embodiment titled, “Mesh
Anchoring Ring,” wherein a balloon catheter 550 has an expandable mesh
anchoring disk 556, which anchors the balloon catheter when expanded,
such that catheter balloon 552 may be inflated to open valve leaflets 126.
Pedersen H 143, 146. Pedersen further discloses that “balloon catheter 550
may be further used as a fixed platform on which prosthetic implants can be
delivered to and deployed on or adjacent to the aortic valve,” and that “[i]n
addition, this fixed platform can be used to deliver and position high energy
sources for debulking valve leaflets such as excimer lasers, high energy low
frequency ultrasound and radio frequency.” Id. 1147.
Thus, because Pedersen discloses using the Petal Anchoring Catheter
as a fixed platform for delivering and deploying prosthetics and also using
the Mesh Anchoring Ring as a fixed platform to deliver and position energy
sources such as ultrasound sources, we determine that it would have been
obvious to use the Petal Anchoring Catheter as a fixed platform for
delivering and deploying energy sources such as ultrasound sources.
However, we agree with Appellant that these disclosures in Pedersen do not
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suggest using ultrasound sources to vibrate anchoring petals 374 of
Pedersen’s Petal Anchoring Catheter, which are for the express purpose of
anchoring the balloon catheter, or that by delivering and deploying energy
sources using Pedersen’s Petal Anchoring Catheter, anchoring petals 374
would be caused to vibrate by the ultrasound energy source so that
anchoring petals 374 fracture the calcification against catheter balloon 376.
Nor does the Examiner provide an adequate reason to believe that the
claimed subject matter would result from the Examiner’s proposed
modification. Therefore, absent hindsight, we see no reason why a person of
ordinary skill in the art would have been led to modify Pedersen’s Petal
Anchoring Catheter to include an energy source operative to vibrate
anchoring petals 374.
Accordingly, we do not sustain the Examiner’s rejection of
independent claims 1 and 22, and claims 4, 5, 13, 21, and 22 depending
therefrom under 35 U.S.C. § 103(a) as unpatentable over Pedersen.
Rejections III—IX
Claims 2, 6, 8, 9. 14. and 16-20 depend from independent claim 1.
The Examiner’s reliance on Evans. Salahieh ’696.
Salahieh ’872, Galdonik, and/or Leone does not cure the deficiency in the
Examiner’s finding with respect to Pedersen as applied to claim 1 as
discussed supra. Final Act. 4—9. Accordingly, for the same reasons stated
supra with respect to Pedersen as applied to claim 1, we do not sustain the
Examiner’s rejection of claims 2, 6, 8, 9, 14, and 16-20 under 35 U.S.C.
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§ 103(a) as unpatentable over Pedersen, and Brisken, Zadno-Azizi, Evans,
Salahieh ’696, Salahieh ’872, Galdonik, and/or Leone.
Rejection X
Regarding independent claim 1, the Examiner finds, inter alia, with
reference to Figure 18D, that Zadno-Azizi’s balloon 426 corresponds to the
claimed impact-producing element, and that Zadno-Azizi’s balloon 402
corresponds to the claimed anvil. Final Act. 9. The Examiner determines
that “the calcification is struck [against the anvil (balloon 402)] by the
impact-producing element [(balloon 426)].” Id. Alternatively, the Examiner
determines that “if a calcification was located between the anvil ([balloon]
402) and the impact-producing element ([balloon] 426), the calcification
would be capable of being hit against anvil by the impact producing
element.” Ans. 17. Appellant argues that “[e]lement 402 is merely another
balloon which is distal to balloon 426 and is no way the structure of an anvil
for 426.” Br. 31.
Zadno-Azizi discloses that main catheter 410 has balloon 412 (“an
occlusive device”) and guidewire 400 has balloon 402 (“an occlusive
device”), such that balloons 402, 412 axe inflated to create an isolated
chamber or working space within vessel 414 that surrounds occlusion 406,
wherein therapeutic procedures can be undertaken to remove or reduce
occlusion 406 without risk of unwanted particles or emboli escaping into the
blood stream. See Zadno-Azizi 19:66 to 20:31; Fig. 18A. Zadno-Azizi
further discloses that once the chamber has been created around the
occlusion, intermediate catheter 420 (“therapy catheter”) is delivered to the
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site of occlusion 406, including a “catheter carrying ... [a] balloon for use in
balloon angioplasty” or catheter-delivered ultrasound device to ablate plaque
within the vessel. See id. at 20:61—67, 21:3—4, 12—14; Fig. 18B.
Specifically, Zadno-Azizi discloses that “balloon angioplasty catheter 420 is
positioned such that the distal end with the balloon 426 thereon is at the site
of the occlusion 406,” and that “balloon 426 is inflated with a suitable
inflation medium ... to cause compression of the plaque of the occlusion
406 against the sidewall of the lumen 414.” Id. at 21:26—36, Fig. 18D.
Thus, Zadno-Azizi does not disclose that occlusion 406 is struck against
balloon 402. Moreover, Zadno-Azizi describes balloon 402 as a device that
occludes vessel 414 to form one end of a chamber, not an anvil against
which anything (including occlusion 406) is struck. Zadno-Azizi also does
not disclose that a calcification is ever situated between balloon 402 and
balloon 426, such that balloon 402 would function as an anvil, as speculated
by the Examiner.
Accordingly, we do not sustain the Examiner’s rejection of
independent claim 1 and claims 2 and 21 depending therefrom under 35
U.S.C. § 103(a) as unpatentable over Zadno-Azizi and Brisken.
Rejection XI
Claim 11 depends from independent claim 1. The Examiner’s
reliance on Saadat and Hong does not cure the deficiency in the Examiner’s
finding with respect to Zadno-Azizi as applied to claim 1 as discussed supra.
Final Act. 10 11. Accordingly, for the same reasons stated supra with
respect to Zadno-Azizi as applied to claim 1, we do not sustain the
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Examiner’s rejection of claim 11 under 35 U.S.C. § 103(a) as unpatentable
over Zadno-Azizi, Brisken, Saadat, and Hong,
Rejection XII
The Examiner finds, inter alia, that distal tip 24 of Noriega’s drive
shaft 22 is an impact-producing element capable of vibrating, however, that
Noriega “fails to disclose an anvil against which the calcification is struck
by the impact-producing element.” Final Act. 11—12 (citing Noriega 1 53).
The Examiner relies on Shturman for disclosing anchoring balloon 24,
which “is expanded to position and stabilize the device.” Id. at 12. The
Examiner reasons that it would have been obvious “to have provided a
balloon catheter having an anchoring balloon mounted thereon to the device
of Noriega, as taught by Shturman, to provide means to stabilize the device
when positioned within the treatment area.” Id. Appellant argues that
“Shturman has nothing to do with an anvil; an anchor is not an anvil.” Br.
31.
The Examiner responds by noting that Appellant’s Specification
discloses that a balloon “may be used an anvil.” Ans. 17 (citing Spec. 1 62;
Fig. 8i (reference numeral 30). The Examiner further determines that
“Noriega discloses an impactor catheter that may be stabilized with balloons
to provide more control when removing occlusive material,” and that
“Shturman teaches a device that is used to remove occlusion and that utilizes
an anchoring balloon to position and stabilize the device,” concluding that
“if calcification is located between the impact-producing element and the
balloon of Shturman when the balloon is expanded to stabilize the device of
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Noriega, the impact-producing elements are capable of hitting the
calcification against the balloon as the energy source vibrates the shaft that
is connected thereto.” Id.
Shturman discloses that “distal portion 25 of the anchoring balloon
[catheter 24] is preferably of a larger diameter, having a shoulder 26 that
contacts the inferior surface of the valve leaflets 12 to accurately and
securely position the anchoring balloon 24, with respect to the valve leaflets
12, providing support to the leaflets to stabilize their positions.'1'’ Shturman
4:50-56, Fig. 1 (emphasis added); see also id. at 10:36-43, Figs. 24—26A;
10:65—11:12, Fig. 25.4 Thus, a preponderance of evidence supports the
Examiner’s finding that Shturman discloses that anchoring balloon 24, and
especially its distal portion 25, provides a supporting surface for the valve
leaflets. In addition, Appellant’s argument does not apprise us of error in the
Examiner’s determination or reasoning that such distal portion 25 would
function as an anvil against which occlusive material would be struck by
Noriega’s distal tip 24 of Noriega’s drive shaft 22, according to the
Examiner’s proposed modification.
Accordingly, we sustain the Examiner’s rejection of independent
claim 1 under 35 U.S.C. § 103(a) as unpatentable over Noriega and
Shturman. Appellant chose not to present separate arguments for the
4 Notably, Shturman also discloses that the deposit removal tool may be “an
ultrasonic vibration generator 144 (e.g., of the type that generates vibrations
in the range of 20,000 Hz). . . connected to a wire 145 having a distal tip
positionable adjacent the calcified deposits, the wire 145 being capable [of]
conveying ultrasonic vibrations.” Id. at 12:29-33, Fig. 34.
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patentability of claims 4 and 7, which depend from claim 1, and therefore,
we also sustain the Examiner’s rejection of claims 4 and 7 under 35 U.S.C.
§ 103(a) as unpatentable over Noriega and Shturman. Br. 31.
Rejection XIII
The Examiner finds, inter alia, that ball 252 of Gifford “is capable of
vibrating to create a mechanical impact,” however, that Gifford “fails to
disclose an anvil against which the calcification is struck by the impact-
producing element.” Final Act. 12—13 (citing Gifford 1103). The Examiner
relies on Shturman for disclosing anchoring balloon 24, which “is expanded
to position and stabilize the device.” Id. at 13. The Examiner reasons that it
would have been obvious “to have provided a balloon catheter having an
anchoring balloon mounted thereon to the device of Gifford, as taught by
Shturman, to provide means to stabilize the device when positioned within
the treatment area.” Id. Appellant argues that “Shturman has nothing to do
with an anvil; an anchor is not an anvil.” Br. 32.
As discussed supra with respect to Rejection XII, Shturman discloses
that anchoring balloon 24, and especially its distal portion 25, provides a
supporting surface for the valve leaflets, and Appellant’s argument does not
apprise us of error in the Examiner’s determination or reasoning that such
distal portion 25 would function as an anvil against which the calcific
deposits in and around the aortic valve would be struck by Gifford’s ball
252, according to the Examiner’s proposed modification.
Accordingly, we sustain the Examiner's rejection of independent
claim 1 under 35 U.S.C. § 103(a) as unpatentable over Gifford and
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Shturman. Appellant chose not to present separate arguments for the
patentability of claim 10, which depends from claim 1, and therefore, we
also sustain the Examiner’s rejection of claim 10 under 35 U.S.C. § 103(a)
as unpatentable over Gifford and Shturman. Br. 31—32.
Rejection XIV
Regarding independent claims 1 and 22, the Examiner finds, inter
alia, that Lemelson’s catheter device 9 is an impactor catheter, including
blade support arms 16, “capable of being brought into contact with a
calcification at a leaflet of the heart valve” and that Lemelson’s balloon 11 is
an anvil “in the form of a balloon against which the calcification is struck by
the impact-producing element.” Final Act. 13—14 (citing Lemelson || 48—
50). Appellant argues that “balloon 11 is not an anvil; nothing is ever hit or
impacted against balloon 11 and balloon 11 is not arranged to act as an
anvil.” Br. 32. In support, Appellant submits that “[elements 16 . . . can
only impact outwards” and as such “elements 16 ... are not capable of
impacting tissue against balloon 11; no force element is provided for such
inward impact.” Id. The Examiner responds that “if calcification is located
between the impact-producing element and the anvil, the repelling and
attracting of the impact-producing element is capable of hitting against [the]
balloon such that the balloon may act as an anvil.” Ans. 18.
Lemelson discloses that “catheter device 9 includes an elongated
flexible tubular structure 10 having an expandable balloon 11 secured
around its distal end” and that “[ejither secured to or integral with the
tubular structure 10 is an annular collar 15 to which are mounted one or
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more cutting blades 18 by means of blade support arms 16.” Lemelson
3:39-41, 50—53. Lemelson further discloses that “[w]ith the balloon 11
deflated, the catheter is able to be positioned at the operative site without
being encumbered by the extended cutting blades,” and that “[o]nce the
distal end is correctly positioned, the cutting blades may be extended simply
by inflation of the balloon 11.” Id. at 4:7—12; see also id. at 4:1—4 (“FIG. IB
shows the catheter with blades 18 in an extended and operable position
whereby expansion of balloon 11 has forced the blade support arms 16
radially outward to thereby operatively extend the cutting blades 18.”).
Lemelson explains that “to cut plaque from the artery walls, the blades 18
are rotated,” or “vibrational energy may be transmitted to the blades 18.” Id.
at 4:12—15. Thus, in Lemelson, balloon 11 is disclosed as a mechanism for
deploying the cutting blades, however, a preponderance of evidence fails to
support the Examiner’s finding that balloon 11 is used as an anvil.
Lemelson also fails to support the Examiner’s determination that Lemelson
discloses locating plaque from the artery walls between balloon 11 and
blades 18.
Accordingly, we do not sustain the Examiner’s rejection of
independent claims 1 and 22, and claims 4 and 21 depending therefrom,
under 35 U.S.C. § 103(a) as unpatentable over Lemelson and Lary.
DECISION
The Examiner’s decision to reject claims 1, 3, 4, and 22 under 35
U.S.C. § 102(b) as anticipated by Kassab is REVERSED.
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The Examiner’s decision to reject claims 1, 4, 5, 13, 21, and 22 under
35 U.S.C. § 103(a) as unpatentable over Pedersen is REVERSED.
The Examiner’s decisions to reject claims 2, 6, S, 9, 14, and 16—20
under 35 U.S.C. § 103(a) as unpatentable over Pedersen, Brisken, Zadno-
Azizi, Evans, Salahieh ’696, Salahieh ’872, Galdonik, and/or Leone are
REVERSED.
The Examiner’s decision to reject claims 1, 2, and 21 under 35 U.S.C.
§ 103(a) as unpatentable over Zadno-Azizi and Brisken is REVERSED.
The Examiner’s decision to reject claim 11 under 35 U.S.C. § 103(a)
as unpatentable over Zadno-Azizi, Brisken, Saadat, and Hong is
REVERSED.
The Examiner’s decision to reject claims 1, 4, and 7 under 35 U.S.C.
§ 103(a) as unpatentable over Noriega and Shturman is AFFIRMED.
The Examiner’s decision to reject claims 1 and 10 under 35 U.S.C.
§ 103(a) as unpatentable over Gifford and Shturman is AFFIRMED.
The Examiner’s decision to reject claims 1, 4, 21, and 22 under 35
U.S.C. § 103(a) as unpatentable over Lemelson and Lary is REVERSED.
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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