Ex Parte Bobo

Board of Patent Appeals and Interferences

Aug 13, 2009

10021132 (B.P.A.I. Aug. 13, 2009)

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.
10/021,132 10/29/2001 Donald E. Bobo JR. CVG-5637 2468
7590 08/13/2009
Debra D. Condino
Edwards Lifesciences LLC
Law Department
One Edwards Way
Irvine, CA 92614
EXAMINER
SHAY, DAVID M
ART UNIT PAPER NUMBER
3769
MAIL DATE DELIVERY MODE
08/13/2009 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DONALD E. BOBO, JR.
__________

Appeal 2009-000892
Application 10/021,132
Technology Center 3700
__________

Decided: August 13, 2009
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
medicament delivery method. The Examiner has rejected the claims as not
being supported by an adequate written description, as anticipated, and/or as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
Appeal 2009-000892
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STATEMENT OF THE CASE
Claims 36-44 are pending and on appeal (App. Br. 3). We will focus
on claims 36, 39, 41, and 42, which read as follows:
36. A method of delivering medicament to tissue in a chamber of the
heart while traversing a right atrium and sealably traversing an atrial septum,
comprising:
introducing a medicament delivery catheter though an endoluminal
entry point and advancing the catheter through a circulatory system;
directing the catheter to traverse the right atrium and puncture the
atrial septum of a patient to form an opening;
supportively engaging the atrial septum at the opening with the
medicament delivery catheter;
sealing the opening with the medicament delivery catheter;
further advancing the medicament delivery catheter through the sealed
opening to a surface on the chamber of the heart; and
creating a channel through the surface of the heart chamber and
delivering medicament into the channel.
39. A method of delivering medicament to tissue while preventing
medicament washout, comprising:
providing a medicament delivery catheter having a tissue engaging
surface with at least one vacuum operated tissue stabilizer port;
providing access to a tissue surface;
advancing the catheter to the tissue surface;
positioning the tissue engaging surface proximate the tissue surface;
sealably engaging the tissue engaging surface to the tissue surface by
activating a vacuum force through the tissue stabilizer port;
forming a sealed opening in the tissue surface;
delivering medicament through the sealed opening in the tissue
surface; and
preventing the medicament from passing between the tissue engaging
surface and the tissue surface to a location outside the sealed opening.
41. The method of claim [39 wherein the catheter comprises at least
one vacuum port positioned radially about the tissue engaging surface and at
least one vacuum lumen located within the catheter and] wherein the
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catheter comprises four vacuum ports positioned on the tissue engaging
surface.
42. A method of delivering medicament to tissue while preventing
medicament washout, comprising:
providing a medicament delivery catheter having a tissue engaging
surface with a sealing balloon;
providing access to a tissue surface;
advancing the catheter to the tissue surface;
positioning the tissue engaging surface proximate the tissue surface;
sealably engaging the tissue engaging surface to the tissue surface by
inflating the sealing balloon;
forming a sealed opening in the tissue surface;
delivering medicament through the sealed opening in the tissue
surface; and,
preventing the medicament from passing between the tissue engaging
surface and the tissue surface to a location outside of the sealed opening.
Claims 36-38 stand rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement (Ans. 3).
Claims 42-44 stand rejected under 35 U.S.C. § 102(e) as anticipated
by Flaherty (US 6,283,951 B1, Sep. 4, 2001) (Ans. 3).
Claims 36-38 stand rejected under 35 U.S.C. § 103(a) as obvious over
Flaherty in view of Jenkins (US 6,645,199 B1, Nov. 11, 2003), Cox
(US 6,161,543, Dec. 19, 2000), and Kalloo (US 2001/0049497 A1, Dec. 6,
2001) (Ans. 3).
Claims 39 and 40 stand rejected under 35 U.S.C. § 103(a) as obvious
over Flaherty in view of Jenkins and Mueller (US 5,725,523, Mar. 10, 1998)
(Ans. 4).
Claim 41 stands rejected under 35 U.S.C. § 103(a) as obvious over
Flaherty in view of Jenkins, Mueller, and Jeevanandam (US 5,807,388,
Sep. 15, 1998) (Ans. 4).
Appeal 2009-000892
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WRITTEN DESCRIPTION
The Examiner finds that claim 36 “contains subject matter which was
not described in the specification in such a way as to reasonably convey to
one skilled in the relevant art that the inventor(s), at the time the application
was filed, had possession of the claimed invention” (Ans. 3). In particular,
the Examiner finds that the “originally filed disclosure . . . is silent on
‘supportively engaging the atrial septum with the medicament delivery
catheter ...’” (id.). The Examiner also finds:
[I]f the term “medicament delivery catheter” is construed to be
the “device 300' ” set forth in the disclosure, this would require
that after the device 300' is “supportively engaging” and thus
attached to the atrial septum via the balloons thereon, it is then
further advanced, which would cause tearing and destruction of
the atrial septum, which is still attached, by virtue of the
device 300' “supportively engaging” it, as the device 300' is
being advanced. Thus as this would have a catastrophic effect
on the health of the patient, the originally filed disclosure,
drawn to medically treating the beating heart, rather than
destroying it, possibly beyond repair, is not a concept that can
fairly be read thereinto.
(Id. at 5.)
Appellant argues that “[s]upport for this recited language can be found
in paragraph 015[2]1 of the present Application (page 38, line 19-page 39,
line 2; amended March 30, 2006)” (App. Br. 9).

1 Appellant referred to paragraph 0151 of the published patent application
(see App. Br. 3, footnote 1), which corresponds to paragraph 0152 of the
original application, which was amended in March 2006. We refer herein to
the paragraph numbering of the application as filed.
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Issue
Did the Examiner err in finding that the Specification does not support
the recitation in claim 36 of “supportively engaging the atrial septum with
the medicament delivery catheter ...”?
Findings of Fact
1. The Specification discloses that an “embodiment of the present
invention is illustrated in Fig. 42a-42c” (Spec. ¶ [0152]). Figs. 42a-42c are
directed to “a tissue-removal and medicament-delivery device” (id. at
¶¶ [0073]-[0075]).
2. The Specification discloses that, “[a]s shown in Fig. 42a, the
device 300' comprises a deflated first balloon 316a and a deflated second
balloon 316b in communication with at least one internal inflation
lumen 318” (id. at ¶ [0152]).
3. The Specification also discloses:
The device 300' is advanced to a position proximate the area of
interest and a hole 320 is formed in the tissue 308a. As shown in
Fig. 42b, the distal portion of the device 300' and the deflated
second balloon 316b is advanced therethrough. Thereafter, the
first balloon 316a and the second balloon 316b are inflated,
thereby supportively engaging the tissue 308a disposed
therebetween. Thereafter the device 300' is advanced to and
engages tissue 308b.
(Id.)
4. In addition, the Specification discloses that this “embodiment
may be used to isolate discrete portion of tissue or organs. For example, the
present invention may be utilized to sealably traverse the atrial septum and
precisely ablate and inject medicament to an isolated chamber of the heart.”
(Id. (as originally filed).)
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Principles of Law
“To fulfill the written description requirement, the patent specification
‘must clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed.’” Gentry Gallery, Inc. v. Berkline
Corp., 134 F.3d 1473, 1479 (Fed. Cir. 1998). “[T]he PTO has the initial
burden of presenting evidence or reasons why persons skilled in the art
would not recognize in the disclosure a description of the invention defined
by the claims.” In re Wertheim, 541 F.2d 257, 263 (CCPA 1976).
Analysis
The Specification discloses a medicament-delivery device 300' having
first and second balloons (Findings of Fact (FF) 1-2). The Specification also
discloses that the distal portion of device 300' (including the deflated second
balloon 316b) is advanced through a hole 320 formed in tissue 308a and
that, thereafter, “the first balloon 316a and the second balloon 316b are
inflated, thereby supportively engaging the tissue 308a disposed
therebetween” (FF 3). In addition, the Specification discloses that this
device “may be utilized to sealably traverse the atrial septum” (FF 4). Thus,
we agree with Appellant that the Specification provides support for the
recitation “supportively engaging the atrial septum at the opening with the
medicament delivery catheter.”
The Specification additionally states that “[t]hereafter the device 300'
is advanced to and engages tissue 308b” (FF 3). Thus, we agree with
Appellant that the Specification additionally supports supportively engaging
the atrial septum as the medicament-delivery catheter is being advanced.
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Conclusion
The Examiner erred in finding that the Specification does not support
the recitation in claim 36 of “supportively engaging the atrial septum with
the medicament delivery catheter ...” We therefore reverse the written
description rejection of claims 36-38.
ANTICIPATION
The Examiner finds that Flaherty teaches the method of claim 42
(Ans. 3). The Examiner refers to Flaherty “Figure 6 and column 13, line 19
to column 14, line 26” (Jun. 30, 2006, Rejection 2). The Examiner finds that
Flaherty discusses “the problem of wash-out, and the attendant global side
effects that arise from administering more of the treating material to remedy
the problem of wash-out . . . , and the desire to remedy these problems”
(Ans. 6-7). Therefore, the Examiner finds that “the porous balloon in the
embodiment of Figure 6 must be construed to provide a degree of ‘sealing’
which at least partially overlaps the spectrum of meaning encompassed by
the term ‘sealing’ as used in the claims at bar” (id. at 7). The Examiner also
finds that “Flaherty teaches the possession of the concept of non-porous
balloons” (id. at 6).
Appellant argues that Flaherty does not disclose “sealably engaging
the tissue engaging surface to the tissue surface by inflating the sealing
balloon,” as recited in claim 42 (App. Br. 13).
Issue
Did the Examiner err in finding that Flaherty anticipates claim 42?
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Findings of Fact
5. Flaherty relates “to systems and methods for delivering
substances into a body, more particularly to systems and methods that use
the cardiovascular system as a conduit to deliver drugs . . . directly to
selected tissue regions within the body” (Flaherty, col. 1, ll. 11-16).
6. Flaherty discloses that, “[i]n current medical therapy, one
method of delivering such drugs involves percutaneously introducing an
infusion catheter into the patient’s cardiovascular system” (id. at col. 1,
ll. 40-42).
7. Flaherty also discloses that the “infusion catheter often includes
a porous perfusion balloon on its distal end,” pores in the balloon being
“arranged to direct the drug from the balloon towards the arterial wall to
improve penetration into the arterial wall and attempt to localize delivery”
(id. at col. 1, ll. 58-63).
8. In addition, Flaherty discloses that, as “an alternative to
perfusion balloons and/or infusion catheters, a drug may be embedded in or
deposited on a catheter, e.g. in the catheter wall, the wall of a non-porous
balloon on the catheter, and/or a coating on the catheter” (id. at col. 2, ll. 11-
14).
9. In discussing its invention, Flaherty discloses a transvascular
catheter system including a puncturing element that “includes a distal tip
adapted to penetrate a wall of a blood vessel to access a tissue region beyond
the wall of the blood vessel” (id. at col. 3, l. 58, to col. 4, l. 1).
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10. Flaherty Figure 6 is reproduced below:

Flaherty Figure 6 depicts a transvascular catheter system including “a drug
delivery catheter deployed into a remote tissue region” (id. at col. 8, ll. 21-
25). Flaherty discloses deploying drug delivery catheter 214 over
puncturing element 14, which includes a solid needle or guide wire
assembly 162 (id. at col. 13, ll. 29-34). Flaherty also discloses that the drug
delivery catheter 214 includes “a porous balloon 218 for infusing the drug in
a predetermined pattern within the tissue region 220” (id. at col. 13, ll. 39-
41).
11. To use the device of Figure 6, Flaherty discloses introducing
the catheter 12 percutaneously into a blood vessel 102, deploying the guide
wire assembly 162 transvascularly to access the selected tissue region 220,
advancing the drug delivery catheter 214 over the guide wire assembly 162,
and inflating the balloon 218, “expanding it from a collapsed condition
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around the drug delivery catheter 214 to an enlarged condition contacting the
surrounding tissue 220” (id. at col. 13, ll. 53-63).
Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of California, 814
F.2d 628, 631 (Fed. Cir. 1987).
Analysis
Flaherty discloses deploying the guide wire assembly 162
transvascularly to access the selected tissue region 220 and advancing the
drug delivery catheter 214 over the guide wire assembly 162 (FF 11). Thus,
Flaherty discloses forming an opening in a tissue surface. In particular,
when the guide wire assembly 162 punctures the blood vessel and continues
into the tissue, an opening in a tissue surface is formed.
In addition, Flaherty discloses inflating a balloon (FF 11). Given that
this balloon is porous (FF 10), we agree with Appellant that inflating this
balloon would not sealably engage a tissue engaging surface of the catheter
to a tissue surface. However, even if we assume that it does, the Examiner
has not adequately explained how inflating the balloon sealably engages the
tissue engaging surface to the tissue surface into which an opening is
formed. Thus, the Examiner has not adequately explained how Flaherty
discloses a method comprising both “sealably engaging the tissue engaging
surface to the tissue surface by inflating the sealing balloon” and “forming
a sealed opening in the tissue surface,” as recited in claim 42.
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The Examiner also notes that Flaherty teaches a non-porous balloon
(Ans. 6; see FF 8). However, the Examiner has not set forth a prima facie
case that Flaherty discloses using a non-porous balloon in the method of
claim 42.
Conclusion
The Examiner erred in finding that Flaherty anticipates claim 42. We
therefore reverse the anticipation rejection of claim 42 and of claims 43 and
44, which depend from claim 42.
OBVIOUSNESS I
The Examiner rejects claims 36-38 as obvious over Flaherty in view
of Jenkins, Cox, and Kalloo (Ans. 3). The Examiner relies on Flaherty for
teaching “a method of myocardial drug delivery” (id. at 3-4). The Examiner
relies on Jenkins for teaching “a method of crossing the septum as claimed”
(id. at 4). The Examiner relies on Cox for teaching “the use of means to seal
the tissue around an internal chamber ablation device to prevent bleeding
when working on a beating heart” (id.). The Examiner relies on Kalloo for
teaching “the use of a dual balloon stabilizing means to aid in the placement
of a surgical device” (id.). The Examiner concludes that it would have been
obvious,
in order to access the myocardium transvenously, to employ the
method of Jenkins et al, since Flaherty et al teach no details of
the transvenous placement method; and . . . to employ the
balloons of Kalloo et al, since this would both stabilize the
devices as well as seal the opening, which is desirable, since
this prevents bleeding when the procedure is performed on a
beating heart, as taught by Cox.
(Id.)
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Appellant argues that none of Flaherty, Cox, and Jenkins teaches
“supportively engaging the atrial septum at an opening with the medicament
delivery catheter and sealing the opening with the medicament delivery
catheter” (App. Br. 15-17). Appellant also argues that “simply combining
the balloons of The Kalloo et al. Publication will not achieve the invention
as recited in claim 36” (App. Br. 16). In particular, Appellant argues:
While the device of The Kalloo et al. Publication may include
balloons, these balloons are not appropriate for use with the
present invention as claimed. For example, the Kalloo balloons
are sized and configured for use on an endoscope during entry
into a stomach and therefore include a relatively large diameter,
large thickness and greater distance between both balloons.
Simply placing these Kalloo balloons on a device appropriately
sized for a cardiac procedure as the Examiner suggests will not
result in a device that can engage and seal an atrial septum as
claimed in claim 36 without some additional teaching as to how
such an adaptation may be performed. The atrial septum is
small and relatively delicate, requiring different design
considerations than the larger and more rugged entry into the
stomach.
(Id.)
Issue
Did the Examiner err in concluding that it would have been obvious to
include Kalloo’s balloons in a catheter that traverses the atrial septum in
order to seal the opening therein?
Findings of Fact
12. Flaherty discloses “a transvascular catheter system 10 for
delivering a drug to a remote tissue region 220 within the myocardium”
(Flaherty, col. 13, ll. 19-22).
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13. Jenkins discloses an “apparatus that facilitates the creation of
circumferential lesions in body tissue,” the apparatus including “a first probe
having a loop structure . . . and a second probe with an expandable push
structure” (Jenkins, Abstract).
14. Jenkins also discloses:
A transseptal technique may be used to direct two separate
probes through two separate sheaths . . . from the right atria,
through the fossa ovalis and into the left atria. One puncture
may be made for each of the probes. Alternatively, given the
elasticity of the membranous portion of the atrial septum, a
single puncture may be made. Once one of the probes has been
inserted through the puncture, the other probe can be wedged
into the left atria between the inserted probe and the perimeter
of the puncture.
(Id. at col. 6, ll. 42-51.)
15. Cox discloses “surgical systems and methods for ablating heart
tissue” (Cox, Abstract).
16. When the procedure is conducted while the heart is still beating,
Cox discloses that “it is necessary to form a hemostatic seal between the
ablation device and the penetration” (id. at col. 15, ll. 56-59).
17. Kalloo discloses “a technique for accessing the peritoneal
cavity via the wall of the digestive tract . . . so that examination of and/or a
surgical procedure in the peritoneal cavity can be conducted via the wall of
the digestive tract with the use of a flexible endoscope” (Kalloo, Abstract).
18. In particular, Kalloo discloses a device including an
“overtube 10 having a conduit 12 that is sized to receive an endoscope
therethrough” (id. at ¶ [0028]).
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19. Kalloo also discloses that the “distal end 20 of the overtube is
adapted to be anchored to the wall of, e.g., the stomach. . . . Such an
anchoring and sealing function is provided . . . by providing a pair of
anchoring cuffs or balloons 22, 24 adjacent the distal end of the overtube.”
(Id. at ¶ [0031].)
20. In addition, Kalloo discloses:
[T]he distal end of the overtube is inserted through an incision
formed in the gastric wall and the anchoring balloons provided
adjacent the distal end are inflated, with one inside the
peritoneal cavity and the other one inside the stomach. . . . The
inflated balloons anchor the distal end 20 of the overtube 10 to
the gastric wall to prevent the overtube from migrating further
into the peritoneal cavity or back into the stomach and isolate
the peritoneal cavity from the gastric cavity.
(Id. at ¶ [0032].)
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l v. Teleflex Inc., 550 U.S. 398, 416 (2007). Obviousness analysis
“need not seek out precise teachings directed to specific subject matter of the
challenged claim.” Id. at 418. Instead, it proper to “take account of the
inferences and creative steps that a person of ordinary skill in the art would
employ.” Id. “A person of ordinary skill is also a person of ordinary
creativity, not an automaton.” Id. at 421.
Analysis
Kalloo discloses including two balloons on the overtube of an
endoscope device and positioning each balloon on one side of the stomach
wall to anchor and seal the stomach wall (FF 17-20). We agree with the
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Examiner that it would have been prima facie obvious to include balloons in
a device that punctures the atrial septum in order to anchor the device and
seal the atrial septum (Ans. 4). In particular, we agree with the Examiner
that one of ordinary skill in the art would have been able select appropriately
sized and configured balloons to seal an atrial septum (id. at 9).
Conclusion
Appellant has not shown that the Examiner erred in concluding that it
would have been obvious to include Kalloo’s balloons in a catheter that
traverses the atrial septum in order to seal the opening therein. We therefore
affirm the obviousness rejection of claim 36. Claims 37 and 38 have not
been argued separately and therefore fall with claim 36. 37 C.F.R.
§ 41.37(c)(1)(vii).
OBVIOUSNESS II
The Examiner rejects claims 39 and 40 as obvious over Flaherty in
view of Jenkins and Mueller (Ans. 4). The Examiner relies on Flaherty and
Jenkins as discussed above (id.). The Examiner relies on Mueller for
teaching “sealing to the cardiac tissue using a vacuum port before creating a
channel in the tissue” (id.). The Examiner concludes that it would have been
obvious “to employ the combined drug injection . . . method of Flaherty et al
and Jenkins et al in the method of Mueller . . . since this is desirable to help
maintain the channels, as taught by Flaherty et al, thus producing a method
such as claimed” (id.).
Appellant argues:
The Mueller Patent is directed to a device which creates a seal
against an area of tissue by providing suction or a vacuum.
This suction, when combined with The Flaherty et al. Patent
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would likely cause the medicament within the porous balloon to
be drawn out and sucked up by the vacuum, reducing the
pressure in the porous balloon and preventing the creation of a
seal. Thus, medicament may pass between the balloon and the
tissue surface.
(App. Br. 18.)
Issue
Did the Examiner err in concluding that the applied references render
claim 39 obvious?
Findings of Fact
21. Flaherty discloses that its “guide wire assembly 162 may
include an anchoring tip (not shown) for fixing the distal tip 164 of the guide
wire assembly 162 in the tissue region 220” (Flaherty, col. 13, ll. 33-36).
22. Mueller discloses a “balloon end contact scope device for
performing laser-assisted transmyocardial revascularization (TMR) or other
surgical and catheter procedures,” the device including “an internal guide
tube extending through the balloon portion for directing a laser delivery
means or other surgical or catheter device through the visualization balloon
toward the area being visualized” (Mueller, Abstract).
23. TMR is “the creation of channels from the epicardial to the
endocardial portions of the heart. The procedure using needles in a form of
‘myocardial acupuncture’” is known. (Id. at col. 2, l. 64, to col. 3, l. 5.)
24. Mueller also discloses:
A fluoroscope locator and guide tether device for use as a
fluoroscopic marker or locator as w[e]ll as a guide tether for a
monorail or other mounted-type fluoroscopic marking tools and
materials, laser delivery means, visualization mean[s] and other
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surgical equipment which can be positioned precisely along the
guide tether adjacent tissue to be inspected or treated.
(Id. at col. 6, ll. 59-65.)
25. In addition, Mueller discloses that the fluoroscope locator and
guide tether device includes a securing means, which is preferably a suction
cup, “for securing the proximal end of the guide tether portion of the device
to tissue or other structure adjacent the subject tissue being visualized,
marked or otherwise treated” (id. at col. 7, ll. 5-9).
26. Mueller also discloses a “vacuum source connected to the
securing means, thereby maintaining the securing means attached to tissue or
other structure by a vacuum seal” (id. at col. 7, ll. 23-28).
Principles of Law
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citation omitted).
A claim “composed of several elements is not proved obvious merely
by demonstrating that each of its elements was, independently, known in the
prior art.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). The relevant
question is “whether there was an apparent reason to combine the known
elements in the fashion claimed by the patent at issue.” Id.
Analysis
Mueller discloses a fluoroscope locator and guide tether device
including a securing means, which is preferably a suction cup, connected to
a vacuum source “for securing the proximal end of the guide tether portion
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of the device to tissue or other structure adjacent the subject tissue being
visualized, marked or otherwise treated” (FF 25-26). However, the
Examiner has not adequately explained how or why this disclosure is being
combined with Flaherty and Jenkins to result in the method of claim 39.
The Examiner argues that it would have been obvious “to employ the
combined drug injection . . . method of Flaherty et al and Jenkins et al in the
method of Mueller . . . since this is desirable to help maintain the channels,
as taught by Flaherty et al, thus producing a method such as claimed”
(Ans. 4). We are not persuaded.
Although Mueller discloses the formation of channels (FF 22-23), the
Examiner has not adequately explained why one of ordinary skill in the art
would have sealed an opening in one of these channels or delivered
medicament through the sealed opening. In particular, the Examiner has not
pointed to any teaching in Flaherty suggesting the desirability of maintaining
revascularization channels by sealing their openings.
Conclusion
The Examiner erred in concluding that the applied references render
claim 39 obvious. We therefore reverse the obviousness rejection of
claim 39 and of claim 40, which depends from claim 39.
OBVIOUSNESS III
The Examiner rejects claim 41 as obvious over Flaherty in view of
Jenkins, Mueller, and Jeevanandam (Ans. 4). The Examiner relies on
Flaherty, Jenkins, and Mueller as discussed above (id.). The Examiner relies
on Jeevanandam for teaching “the use of multiple vacuum ports to secure a
channel-forming device to the cardiac wall so as to form chambers therein”
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(id. at 4-5). The Examiner concludes that it would have been obvious “to
provide multiple ports, as taught by Jeevanandam et al, since this provides
secure fixation and to provide four ports, since the number of ports can be
varied as desired, as taught by Jeevanandam et al, thus producing a method
such as claimed” (id. at 5).
Appellant argues that the “arguments presented with regard to
claims 39 and 40 . . . are equally applicable to claim 41” (App. Br. 19).
Appellant also argues that Jeevanandam “does not teach multiple vacuum
ports” (id.).
Issue
Did the Examiner err in concluding that the applied references render
claim 41 obvious?
Findings of Fact
27. Jeevanandam discloses:
a method for myocardial revascularization . . . , comprising
entering the ventricle of the heart with a catheter having a
lumen which houses a fiber which emits energy at a fiber end
. . . and emitting energy from said fiber end in an amount
sufficient to form a channel in the ventricular wall into the
myocardium to thereby increase blood flow from the
endocardium to the myocardium.
(Jeevanandam, col. 2, ll. 10-19.)
28. Jeevanandam also discloses that “the insertable end 24 of the
[catheter 22] has gripping means extending therefrom in the form of three
suctions cups 44” and that these “cups 44 provide a means to removably
mount and stabilize the insertable end 24 to the inner ventricular wall, and
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serves as a tripod for the end 24, and the fiber end 32” (id. at col. 4, l. 66, to
col. 5, l. 4).
Analysis
Jeevanandam discloses a catheter with an insertable end having
“gripping means extending therefrom in the form of three suctions cups 44
. . . to removably mount and stabilize the insertable end 24 to the inner
ventricular wall” (FF 28). The Examiner does not show that Jeevanandam
discloses a device having multiple vacuum ports. However, even assuming
that it would have been obvious to connect a vacuum port to each of
Jeevanandam’s suction cups based on the disclosure in Mueller, the
Examiner has not adequately explained how or why this disclosure is being
combined with Flaherty and Jenkins to result in the method of claim 41.
Conclusion
The Examiner erred in concluding that the applied references render
claim 41 obvious. We therefore reverse the obviousness rejection of
claim 41.
SUMMARY
We affirm the obviousness rejection of claims 36-38. However, we
reverse the written description rejection of claims 36-38, the obviousness
rejection of claims 39-41, and the anticipation rejection of claims 42-44.
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
Appeal 2009-000892
Application 10/021,132

21
lp

DEBRA D. CONDINO
EDWARDS LIFESCIENCES LLC
LAW DEPARTMENT
ONE EDWARDS WAY
IRVINE CA 92614