Ex Parte Gunday et al

Patent Trial and Appeal Board

Jun 26, 2017

13037874 (P.T.A.B. Jun. 26, 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.
13/037,874 03/01/2011 Erhan H. Gunday 04530-P0011A 7726
24126 7590 06/28/2017
ST. ONGE STEWARD JOHNSTON & REENS, LLC
986 BEDFORD STREET
STAMFORD, CT 06905-5619
EXAMINER
TORRES DIAZ, ARNALDO
ART UNIT PAPER NUMBER
3779
NOTIFICATION DATE DELIVERY MODE
06/28/2017 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):
patentpto@ ssjr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERHAN H. GUNDAY and LAWRENCE J. GERRANS
Appeal 2015-002780
Application 13/037,874
Technology Center 3700
Before JAMES P. CALVE, GEORGE R. HOSKINS, and
FREDERICK C. LANEY, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Erhan H. Gunday and Lawrence J. Gerrans (“Appellants”)1 appeal
under 35 U.S.C. § 134 from the Examiner’s decision rejecting claims 1—44
in this application. The Board has jurisdiction over the appeal under
35 U.S.C. § 6(b).
We REVERSE.
1 The Appeal Brief identifies Sanovas, Inc. as the real party in interest.
Appeal Br. 3.
Appeal 2015-002780
Application 13/037,874
CLAIMED SUBJECT MATTER
Claims 1, 20, and 36 are independent. Claim 1 illustrates the claimed
subject matter, and it recites:
1. A steerable catheter device comprising:
a catheter body having a distal section, the distal section
having
an inner lumen; and
a plurality of steering lumens radially offset from said inner
lumen, each steering lumen having a first end having a first
diameter and a second end having a second diameter smaller
than the first diameter; and
a fluid source in fluid communication with each of said
plurality of steering lumens for supplying at least one of a fluid
and a vacuum thereto to change the diameter thereof.
Appeal Br. 26 (Claims App.) (emphasis added).
REJECTIONS ON APPEAL
Claims 1-3, 5-9, 13, 14, 17-22, 2A-27, 31, 32, 34, 36-39, and 41
stand rejected under 35 U.S.C. § 103(a) as unpatentable over Kennedy
(US 2007/0100235 Al, pub. May 3, 2007).
Claims 4, 15, 23, and 33 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Kennedy and Bose (US 2009/0030400 Al, pub. Jan. 29,
2009).
Claims 10-12, 28—30, 43, and 44 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Kennedy and Masterson (US 5,392,766, iss.
Feb. 28, 1995).
Claims 16, 35, and 42 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Kennedy and Seibel (US 2008/0147000 Al, pub. June 19,
2008).
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Application 13/037,874
Claim 40 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Kennedy and Skerven (US 2010/0168665 Al, pub. July 1, 2010).
ANALYSIS
A. Obviousness over Kennedy
Claims 1—3, 5—9, 13, 14, and 17—19
In rejecting claim 1, the Examiner finds Kennedy’s Figure 9
substantially discloses the claimed subject matter, the sole exception being
the Figure 9 catheter is not disclosed to “change the diameter” of steering
lumens 33, 41 as claimed. Final Act. (mailed Oct. 21, 2013), 3^4. The
Examiner finds Kennedy, instead, discloses the Figure 9 catheter adjusts
fluid pressure within steering lumens 33, 41 to “change[] the lumens to
distend axially’'’ along the longitudinal direction of the catheter. Id. at 4
(emphasis added). Nonetheless, according to the Examiner, “alternate
embodiments” of Kennedy expand and contract the diameters of steering
lumens.2 Id. (citing Kennedy Fig. 10). The Examiner determines it would,
therefore, have been obvious “to configure the steering lumens [of Figure 9]
with material characteristics to allow [them] to distend in the direction(s)
2 Appellants argue that the Examiner “admits” Kennedy fails to disclose
changing the diameter of a steering lumen. Appeal Br. 11—12; Reply Br. 2.
The Final Office Action contains inconsistent statements in this respect. See
Final Act. 4 (stating both that “Kennedy does not explicitly disclose said
change in lumen as changing the diameter of the lumen” and that Kennedy
discloses “alternate embodiments of expanding/contracting diameters of said
lumens”). However, the rejection as a whole indicates the Examiner’s
position to be the catheter of Figure 9 is not disclosed as changing the
diameter of steering lumens 33 and 41, but other catheter embodiments in
Kennedy change the diameter of steering lumens. See Final Act. 3—4, 19—
21; Ans. 19-23.
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Application 13/037,874
necessary to effectively and efficiently steer the catheter based at least upon
the intended use and/or the vessel passageway as taught by Kennedy (para.
[0047]).” Id. at 4.
Appellants argue Kennedy fails to motivate, and in fact teaches away
from, the Examiner’s modification of the Figure 9 catheter to allow fluid
pressure to change the diameter of steering lumens 33, 41. Appeal Br. 14—
19; Reply Br. 8—9. For the following reasons, we disagree with Appellants’
argument that Kennedy teaches away from fluid pressure changing the
diameter of the steering lumens. Nonetheless, we are persuaded that the
Examiner has failed to provide an articulated reasoning with rational
underpinning to support the legal conclusion of obviousness. See In re
Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) {cited with approval in KSR Int’l
Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)).
Kennedy discloses “radial ballooning of the actuating lumen” (i.e.,
changing the diameter of a steering lumen) is a “problem[]” in prior art
catheters, because it “reduc[es] the fluid force in the longitudinal direction
such that there is inadequate fluid force at the distal end to cause the catheter
to bend.” Kennedy 13, 15. Kennedy suggests solving this problem with
“an optional anisotropic material that is . . . relatively compliant in an axial
direction as compared to a transverse direction,” such as by
“circumferentially reinforcing” the distal end of the catheter. Id. ]Hf 15, 51
(emphasis added). In “one embodiment” the circumferential reinforcement
“may comprise” inner reinforcement 130 that resists radial compression. Id.
| 65 & Fig. 2A. In another embodiment, the circumferential reinforcement
may comprise outer reinforcement 140 that resists radial expansion and/or
radial compression. Id. 1 68 & Fig. 2C.
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Application 13/037,874
These disclosures indicate Kennedy merely prefers embodiments
wherein the diameter of a steering lumen is not changed with changing fluid
pressures. See also id. 195 (circumferential reinforcements “may” be
provided in Figure 9). Indeed, Kennedy discloses at least one embodiment
wherein the diameter of a steering lumen is changed by changing fluid
pressures within the lumen. See id. ]Hf 96—98 & Figs. 10A—10C (illustrating
the diameters of occluded distal ends 32 and 40 changing with changing
fluid pressures). Thus, we determine Kennedy does not teach away from
changing the diameter of a steering lumen by changing fluid pressures. The
“mere disclosure of alternative designs does not teach away” and “just
because better alternatives exist in the prior art does not mean that an
inferior combination is inapt for obviousness purposes.” In re Mouttet, 686
F.3d 1322, 1334 (Fed. Cir. 2012) (citations omitted); see also In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004) (to teach away, a reference must
actually criticize, discredit, or otherwise discourage the claimed solution).
At the same time, Kennedy does reflect a clear preference for
embodiments in which the diameter of a steering lumen does not change
with changing fluid pressures, because Kennedy teaches that such radial
expansion (ballooning) may result in inadequate fluid force at the distal end
that is needed to cause the catheter to bend via axial expansion. Kennedy
]Hf 13, 15,51. In the face of that preference, the Examiner determines it
would have been obvious to modify the catheter of Kennedy’s Figure 9 to
incorporate a steering lumen diameter that changes with changing fluid
pressures, “to allow [the catheter] to distend in the direction(s) necessary to
effectively and efficiently steer the catheter based at least upon the intended
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use and/or the vessel passageway as taught by” paragraph 47 of Kennedy.
Final Act. 4. That paragraph most pertinently states:
Similarly, the dimensions of the catheter will depend on
various factors. These factors include the intended use of the
catheter and the vessel passageway or the channel of an
endoscope or accessory device into which the catheter will be
positioned. In general, however, the catheter is elongate,
meaning that it is relatively long enough to reach a target site at
a region internal the patient’s body. The overall catheter length
may vary greatly, however, depending on the intended medical
procedure for the device and the location of the target site
internal the patient’s body.
Kennedy 147 (emphases added).
Paragraph 47 of Kennedy does not provide a rational underpinning to
support the Examiner’s modification of Kennedy’s Figure 9 to incorporate a
steering lumen diameter that changes with changing fluid pressures.
Specifically, the Examiner has not established a rational relationship
between dimensioning a catheter for use in a particular passageway, and
whether or not the steering lumen(s) of the catheter change diameter as the
fluid pressure changes within the lumen(s) to steer the catheter. It is not
clear, and the Examiner does not explain, how deflecting a catheter distal
section via changing the diameter of steering lumens has anything to do with
the appropriate dimensioning of the catheter to fit in differently-sized
passageways or channels.
For the foregoing reasons, we conclude the Examiner errs in rejecting
claim 1 as unpatentable over Kennedy. The Examiner’s additional
consideration of claims 2, 3, 5—9, 13, 14, and 17—19, each of which depends
directly or indirectly from claim 1, does not cure the noted deficiency in the
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rejection of claim 1. See Final Act. 4—6. Therefore, we also do not sustain
the rejection of those claims as unpatentable over Kennedy.
Claims 20—22, 24—27, 31, 32, 34, 36—39, and 41
Independent claim 20 recites a steerable catheter device having a
steering lumen that receives a fluid “to radially distend” the steering lumen.
Appeal Br. 29 (Claims App.). Independent claim 36 recites a method of
orienting a catheter device, comprising the step of bending the catheter body
“by supplying a fluid to radially distend [a] steering lumen.” Id. at 31—32
(Claims App.).
Thus, the phrasing of these claims is somewhat different from
claim 1 — “change the diameter” of a lumen (claim 1) versus “radially
distend” a lumen (claims 20 and 36). Nonetheless, the Examiner’s
obviousness analysis is the same. See Final Act. 3^4 (claim 1), 6—7
(claim 20), 9—10 (claim 36). That analysis is in error for the reasons
provided above. We therefore do not sustain the rejection of claims 20 and
36, and their respective dependent claims 21, 22, 24—27, 31, 32, 34, 37—39,
and 41, as unpatentable over Kennedy.
B. Obviousness over Kennedy and one of
Bose, Masterson, Seibel, or Skerven
The Examiner’s additional consideration of dependent claims 4, 10—
12, 15, 16, 23, 28—30, 33, 35, 40, and 42-44 in light of Bose, Masterson,
Seibel, or Skerven does not cure the noted deficiency as to the rejection of
the independent claims over Kennedy. See Final Act. 11—16. Therefore, we
do not sustain the rejection of these claims as unpatentable over Kennedy
and Bose, Masterson, Seibel, or Skerven.
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Application 13/037,874
DECISION
The Examiner’s decision to reject claims 1—44 is reversed.
REVERSED
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