Ex Parte Nahon et al

Patent Trial and Appeal Board

Sep 14, 2017

11347854 (P.T.A.B. Sep. 14, 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.
11/347,854 02/06/2006 Daniel Nahon 1213-5U 4906
89554 7590 09/18/2017
Christopher & Weisberg, P.A.
200 East Las Olas Boulevard
Suite 2040
Fort Lauderdale, EL 33301
EXAMINER
HOUSTON, ELIZABETH
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/18/2017 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 DANIEL NAHON and WILLARD W. HENNEMANN1
Appeal 2016-006268
Application 11/347,854
Technology Center 3700
Before RICHARD J. SMITH, DEVON ZASTROW NEWMAN, and
DAVID COTTA, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a medical
device, such as a perfusion device for treating ischemia and vascular
occlusions. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
1 According to Appellants, the real party in interest is Medtronic Cryocath
LP. (Appeal Br. 1.)
Appeal 2016-006268
Application 11/347,854
STATEMENT OF THE CASE
Claims on Appeal
Claims 1, 2, 4, 7, 13, and 14 are on appeal.2 (Claims Appendix,
Appeal Br. 15—20.) Claims 1 and 13 are the only independent claims and
read as follows (emphases added):
1. A medical device, comprising:
an elongate body defining a proximal end and a distal end, the
elongate body further defining an inflation lumen defining a fluid pathway
longitudinally extended through the elongate body and an exhaust lumen
defining a fluid pathway longitudinally extended through the elongate body
adjacent to the inflation lumen;
a first expandable element coupled to the elongate body, wherein the
first expandable element is in fluid communication with the inflation lumen
and the exhaust lumen;
a second expandable element coupled to the elongate body at a
location proximal of the first expandable element, wherein the second
expandable element is in fluid communication with the inflation lumen and
the exhaust lumen; and
a perfusion path disposed within the elongate body through an interior
of the first expandable element and an interior of the second expandable
element, the perfusion path being thermally affected by the first expandable
element and including a perfusion lumen defining an inlet aperture in the
elongate body at a location between the first expandable element and the
second expandable element that is in fluid communication with an
environment external to the device, at least a portion of the perfusion path
extending from the perfusion lumen to a region distal of the first expandable
element and defining an outlet aperture that is in fluid communication with
the environment external to the device and in fluid communication with the
2 Claims 15—24 are withdrawn from consideration. (Final Act. 2, dated May
26, 2015.)
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Application 11/347,854
inlet aperture, wherein the second expandable element controls a fluid flow
rate into the inlet aperture of the perfusion lumen.
13. A medical device, comprising:
an elongate body defining a proximal end and a distal end, the
elongate body further defining a first injection lumen longitudinally disposed
within the elongate body, a second injection lumen longitudinally disposed
within the elongate body, a first exhaust lumen longitudinally disposed
within the elongate body, and a second exhaust lumen longitudinally
disposed within the elongate body;
a first expandable element coupled to the elongate body, wherein the
first expandable element is in fluid communication with the first injection
lumen and the first exhaust lumen and fluidly isolated from the second
injection lumen and the second exhaust lumen;
a second expandable element coupled to the elongate body at a
location proximal of the first expandable element, wherein the second
expandable element is in fluid communication with the second injection
lumen and the second exhaust lumen and fluidly isolated from the first
injection lumen and the first exhaust lumen;
a perfusion path disposed within the elongate body through an interior
of the first expandable element and an interior of the second expandable
element, the perfusion path being thermally affected by the first expandable
element and including a perfusion lumen defining an inlet aperture in the
elongate body at a location proximal to the second expandable element that
is in fluid communication with an environment external to the device, at
least a portion of the perfusion path extending from the perfusion lumen
aperture to a region distal of the first expandable element and defining an
outlet aperture that is in fluid communication with the environment external
to the device and in fluid communication with the inlet aperture of the
perfusion lumen; and
a sheath movably disposed about an exterior portion of the elongate
body and adapted to control a fluid flow rate into the perfusion lumen
aperture and through the perfusion path.
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Application 11/347,854
Examiner’s Rejections
1. Claims 1, 2, 4, and 7 stand rejected under pre-AIA 35 U.S.C. § 103(a)
as unpatentable over Samson3 and Sterman.4 (Ans. 2 4.)
2. Claims 13 and 14 stand rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Samson, Sterman, and Weikl.5 (Id. at 4—6.)
DISCUSSION
Rejection No. 1
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection under pre-AIA 35 U.S.C. § 103(a).
Analysis
The obviousness rejection is based on the Examiner’s position that
Samson teaches a perfusion lumen 118 “defining an inlet aperture (perfusion
port 112) in the elongate body at a location between the expandable
elements” (Ans. 3), as illustrated in Fig. 12 of Samson. The Examiner
acknowledges that “Samson does not disclose an outlet aperture in fluid
communication with the inlet aperture distal the first expandable element,”
and relies on Sterman for teaching that limitation. (Id.)
Figure 12 of Samson is illustrated below:
3 Samson et al., US 2003/0036728 Al, pub. Feb. 20, 2003 (“Samson”).
4 Sterman et al., US 6,699,231 Bl, issued March 2, 2004 (“Sterman”).
5 Weikl et al., US 4,610,662, issued Sept. 9, 1986 (“Weikl”).
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Application 11/347,854
FIG. 12 above is an illustration of two flow control elements deployed in a
patient’s aorta. (Samson 126.)
Appellants argue that Samson “discloses that ‘[ujsing a multihead
cardiopulmonary bypass pump or the like, perfusion of oxygenated blood is
started through perfusion lumen 108 and out the perfusion ports 112 *
(Samson, |[0071]; emphasis added). Therefore, the ‘perfusion ports 112’ of
the Samson reference are outlet ports, not inlet ports.” (Appeal Br. 9.)
Thus, according to Appellants, the combination of Samson and Sterman fails
to teach or suggest “an inlet aperture in the elongate body at a location
between the first expandable element and the second expandable element”
(id. at 8—9), or “an outlet aperture that is in fluid communication with the
inlet aperture'’'’ (id. at 9).
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Application 11/347,854
The Examiner responds that
the ports 112 of the Samson device are considered to be fully
capable of acting as inlet ports if one desired. While the Samson
reference only discusses the ports being used in the manner as
defined by Appellants] as the outlet direction^] the structure of
the Samson reference is considered to nonetheless read on the
structure of the claim limitation.
(Ans. 7.) The Examiner further responds that even an outlet port may be
considered an inlet port because “the ports 112 are providing an inlet from
inside the catheter shaft 102 to outside the catheter of Samson.” (Id.)
We find that Appellants have the better position. A prima facie case
for obviousness “requires a suggestion of all limitations in a claim,” CFMT,
Inc. v. Yieldup Inti Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003), and “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”
KSRIntI Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Here, the Examiner does not persuasively explain how the ports 112
are capable of acting as inlet ports, or why a person of ordinary skill in the
art would modify Samson so that ports 112 function as inlet ports. Even if
the Samson device could be so modified, “[t]he mere fact that the prior art
could be so modified would not have made the modification obvious unless
the prior art suggested the desirability of the modification.” In re Gordon,
733 F.2d 900, 901 (Fed. Cir. 1984) (reversing obviousness rejection where
claim to a blood filter having the blood inlet and outlet located at the bottom
end of the filter was rejected based on prior art disclosing a liquid strainer in
which the inlet and outlet were at the top end of the strainer).
The structure recited in claim 1 includes “a perfusion lumen defining
an inlet aperture in the elongate body at a location between the first
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Application 11/347,854
expandable element and the second expandable element,” which inlet
aperture the Examiner identifies as ports 112.6 (Ans. 3.) However, the
Examiner points to no motivation for a modification of the lumen such that
the outlet ports 112 function as inlet ports. Moreover, while a port or
aperture may theoretically be “capable” of use as an inlet or outlet for a
fluid, the structure of Samson is such that the modification of the lumen
outlet ports 112 between the expandable elements to function as inlet ports
may well require a substantial modification of Samson, and possibly render
it inoperable for its intended purpose. (See Reply Br. 4: “the ‘perfusion
ports 112’ of the Samson reference . . . cannot function like inlet ports
because the Samson system includes a ‘multihead cardiopulmonary bypass
pump or the like,’ which creates a flow out of the ‘perfusion ports 112.’”);
see also Gordon, 733 F.2d at 902.
The Examiner’s additional position — that ports 112 provide an inlet
from inside to outside the catheter — is inapt because the Examiner’s stated
motivation for combining Sterman with Samson is to provide an outlet
aperture in fluid communication with the inlet aperture “in order to allow for
delivery of a perfusate distally of the balloons.” (Ans. 3—4.) In the
Examiner’s proposed notion of modifying the outlet ports 112 to serve as
inlet ports to the outside of the catheter (Ans. 7), the Examiner does not
explain what would then be considered the outlet aperture that is in fluid
communication with the so called “inlet” aperture, as required by the claims.
6 In connection with claim 13, the Examiner identifies ports 126 of Samson
as inlet ports, but they are not between the expandable elements, as required
by claim 1. (Ans. 4—5.)
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Accordingly, the rejection of claim 1 is reversed. Dependent claims 2,
4, and 7 stand with claim 1.
Rejection No. 2
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection under pre-AIA 35 U.S.C. § 103(a).
Analysis
We adopt as our own the Examiner’s findings and conclusions
regarding the rejection of claim 13 under Section 103, as set forth in the
Advisory Action dated Aug. 3, 2015 (regarding FIG. 6E of Sterman), and
Answer {see, e.g., Ans. 4—6). We discern no error in the Examiner’s
rejection of claim 13 as obvious.
Unlike claim 1, claim 13 refers to the inlet aperture as proximal to the
second expandable element (i.e., not between the expandable elements).
(Appeal Br. 17.) Furthermore, rather than ports 112, the Examiner identifies
ports 126 (see FIG. 12 above) in Samson as the inlet aperture. (Ans. 4—5.)
The Examiner also points to Figure 6E of Sterman (shown below) in which
“the perfusion lumen 266 provides the fluid communication between the
inlet hole 268 and the outlet hole 270 of the device” (Ans. 8) which
“teach[es] and suggests] an outlet aperture that is [in] fluid communication
with an inlet aperture in the elongate body, as required by the claims” (Adv.
Act. at 2). Figure 6E of Sterman is illustrated below:
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262 264 270
FIG. 6E above is an illustration of a catheter. (Sterman col. 13,11. 22—23.)
Appellants contest the rejection of claim 13 by essentially relying on
the arguments advanced in connection with claim 1, including reference to
the Examiner’s statements regarding Samson in connection with the
rejection of claim 1 at page 3 of the Final Action. (Appeal Br. 11—12.)
Appellants also argue that the combination of Samson and Sterman fails to
teach or suggest an inlet aperture located between the first and second
expandable elements or an outlet aperture that is in fluid communication
with the inlet aperture. (Id. at 12.)
We are not persuaded by Appellants’ arguments. The Examiner’s
rejection is based on inlet ports 126, which are proximal to the second
expandable element in Samson (see FIG. 12 above), not inlet aperture 112.
(See Final Act. 5.) Moreover, claim 13 does not require that the inlet
aperture be located between the expandable elements. Finally, Appellants
do not dispute that ports 126 of Samson are inlet ports or address the
teachings of Sterman identified by the Examiner, as illustrated in FIG. 6E
above. (See Appeal Br. 11—12.)
Accordingly, for the reasons of record and as set forth above, we
affirm the rejection of claim 13. Claim 14 was not argued separately and
falls with claim 13.
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Conclusions of Law
A preponderance of evidence of record fails to support the Examiner’s
rejection of claim 1 for obviousness. Dependent claims 2, 4, and 7 stand
with claim 1.
A preponderance of evidence of record supports the Examiner’s
rejection of claim 13 for obviousness. Dependent claim 14 falls with claim
13.
SUMMARY
We reverse the rejection of claims 1, 2, 4, and 7, and affirm the
rejection of claims 13 and 14.
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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