Ex Parte Freed

Board of Patent Appeals and Interferences

Jan 12, 2011

10760520 (B.P.A.I. Jan. 12, 2011)

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.
10/760,520 01/21/2004 David I. Freed 1001.2489101 1095
11050 7590 01/13/2011
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
KASZTEJNA, MATTHEW JOHN
ART UNIT PAPER NUMBER
3779
MAIL DATE DELIVERY MODE
01/13/2011 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 DAVID I. FREED
____________

Appeal 2009-009625
Application 10/760,520
Technology Center 3700
____________

Before: LINDA E. HORNER, MICHAEL W. O’NEILL, and
FRED A. SILVERBERG, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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Application 10/760,520

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STATEMENT OF THE CASE
David I. Freed (Appellant) seeks our review under 35 U.S.C. § 134 of
the Examiner’s decision rejecting claims 1-7, 10-18, 28-37, 39, 40, 43-53,
56, 58-64, 66, 67, 69-75, 81, 82, 87-89, 93, and 97-102.2 Claims 19-21, 23-
27, 41, 42, 57, 68, 76-80, 83-86, 90-92, and 94-96 are withdrawn from
consideration.3 Claims 8, 9, 22, 38, 54, 55, and 65 are cancelled. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
THE INVENTION
Appellant’s claimed invention is “an endoscopic device that combines
tissue cutting and spraying in a single device for use in, for example, a
colonoscopic polypectomy.” Spec. para. [001]. Claim 1 is reproduced
below.
1. A medical device comprising:
a proximal handle;
an elongated member having a proximal end, a distal end,
and a lumen therebetween, the proximal end being coupled to
the proximal handle, the elongated member being sufficiently
flexible to traverse through tortuous anatomy of a patient’s
body;

2 Appellant requests allowance of the rejected claims. App. Br. 33. We treat
such a request for allowance as a request to reverse the rejection.
3 Appellant requests allowance of the withdrawn claims (App. Br. 6, 33);
however, the withdrawn claims are not before us because the Board reviews
adverse decisions of the Examiner and the withdrawn claims were not
rejected in the Office Action that is the subject of this appeal. See 35 U.S.C.
§ 6(b); see also Office Action dated September 5, 2007.
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an end effector consisting essentially of a snare loop
proximate the distal end of the elongated member, actuation of
the proximal handle causing the snare loop to sever tissue; and
a distal member configured to open and substantially
close the distal end of the lumen, the distal member defining a
flow path such that, when the distal member substantially
closes the distal end of the lumen, the flow path enables a flow
communication between the lumen and an outside of the
elongated member.
THE REJECTIONS
Appellant seeks review of the following rejections:
1. Rejection of claims 1-4, 10-18, 28-37, 39, 40, 43-53, 56, 58-64, 66,
67, and 97-100 under 35 U.S.C. § 103(a) as being unpatentable over
Konomura (US 4,682,599, issued July 28, 1987) and Levinson
(US 6,660,011 B2, issued December 9, 2003).
2. Rejection of claims 5-7 under 35 U.S.C. § 103(a) as being
unpatentable over Konomura, Levinson, and McAlister (US 5,599,324,
issued February 4, 1997).
3. Rejection of claims 69-75, 81, 82, 89, 93, and 101 under 35 U.S.C.
§ 103(a) as being unpatentable over Konomura, Levinson, and Okada
(US 5,871,440, issued February 16, 1999).
4. Rejection of claims 87, 88, and 102 under 35 U.S.C. § 103(a) as being
unpatentable over Konomura, Levinson, and Termanini (US 4,204,528,
issued May 27, 1980).
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ISSUES
The issues presented by this appeal are:
Would the disclosures of Konomura and Levinson have led a person
of ordinary skill in the art to “an end effector consisting essentially of a
snare loop” as called for in independent claims 1, 34, 47, and 59?
Did the Examiner articulate a sufficient reason with rational
underpinning to explain why a person having ordinary skill in the art would
have been led to modify the flow path of Konomura in light of the teaching
of Okada so that a portion of the flow path has a cross-sectional flow area
smaller than both a cross-sectional flow area of an inlet of the flow path and
a cross-sectional flow area of an outlet of the flow path, to arrive at the
invention of claims 69, 89, and 93?
Did the Examiner articulate a sufficient reason with rational
underpinning to explain why a person having ordinary skill in the art would
have been led to modify the flow path of Konomura in light of the teaching
of Termanini so that “the flow path comprises an inlet and a plurality of
outlets connecting to the inlet,” to arrive at the invention of claim 87?
ANALYSIS
Rejection of claims 1-4, 10-18, 28-37, 39, 40, 43-53, 56, 58-64, 66, 67, and
97-100 under 35 U.S.C. § 103(a) as being unpatentable over Konomura and
Levinson
Independent claims 1 and 34 are each directed to a medical device that
includes an end effector “consisting essentially of a snare loop” that severs
tissue when actuated. Similarly, independent claims 47 and 59 are method
claims that include the steps of actuating an end effector “consisting
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essentially of a snare loop” to severe tissue of a tissue tract. Appellant’s
Specification describes that the endoscopic device 10 includes an end
effector such as snare loop 40. Spec. para. [024]; figs. 1, 2, 5, 6.
Appellant’s Specification consistently describes that the endoscopic device
combines the ability to sever tissue (e.g., perform a polypectomy) and enable
flow communication between the lumen and the outside of the lumen (dye
spraying) in a single device. See, e.g., Spec. paras. [005], [040], [041], and
[047]. Appellant’s Specification does not describe the endoscopic device
performing other functions (e.g., retrieving severed tissue). Spec. passim.
The Examiner’s conclusion of obviousness is based on the claim
interpretation that “an end effector consisting essentially of a snare loop” is
equivalent to “an end effector comprising a snare loop.” Ans. 10 (citing
MPEP § 2111.03, 8th ed., rev. 8, July 2008). We cannot agree with this
claim construction. Because claims 1, 34, 47, and 59 call for an end effector
“consisting essentially of a snare loop,” the actual structure of the end
effector is limited to the claimed snare loop, as well as those additional
elements that “do not materially affect the basic and novel properties of the
invention.” PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1354
(Fed. Cir. 1998). “[A]ppellant has the burden of showing the basic or novel
characteristics of [the claimed invention].” See In re De Lajarte, 337 F.2d
870, 874 (CCPA 1964).
Appellant argues that it is a basic and novel characteristic of the
claimed device to enable flow communication between the lumen and the
outside of the elongated member (“spraying fluid”), and that the end effector
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is only a snare loop operated by a single control member so that the flow
through the lumen and to the nozzle (50) is not inhibited. App. Br. 14-15;
Reply Br. 3.
Independent claims 1 and 34 call for the distal member (or nozzle) to
define a flow path that enables a flow communication between the lumen of
the elongated member and the outside of the elongated member. Similarly,
method claims 47 and 59 call for a nozzle (or distal member) to define a
flow path permitting fluid communication between the lumen and the
outside of the lumen (or the outside of the elongated member).
Consequently, we agree with Appellant that it is a basic and novel
characteristic of the claimed device for the flow path to permit fluid
communication between the lumen and the outside of the lumen (or the
outside of the elongated member).
We interpret claims 1, 34, 47, and 59 to call for an end effector that
consists of a snare loop and only those components that do not materially
affect fluid communication between the lumen and the outside of the lumen.
The Examiner found that Konomura discloses an end effector (basket
3 comprised of wires 6) for holding or fracturing a foreign matter, but that
Konomura is silent regarding an end effector that severs tissue when
actuated. Ans. 4-5. The Examiner found that Levinson discloses an end
effector that severs tissue when actuated (second set of wires 28). Ans. 5.
The Examiner concluded that it would have been obvious “to have a tissue
cutting end effector in the apparatus of Konomura to selectively capture, cut
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and/or retrieve polyps and other aggregates of organic tissue from a patient’s
internal organs as taught by Levinson.” Id.
It is unclear to us from the wording the Examiner chose to articulate
the rejection as to whether the Examiner is proposing to add Levinson’s end
effector (second set of wires 28) to Konomura’s end effector (basket 3
comprised of wires 6) or to substitute one for the other. Given that Levinson
discloses that a snare loop (e.g., second set of wires 28) has no ability to
capture or retrieve an excised lesion (Levinson, col. 1, ll. 32-35), and that the
Examiner concludes the proposed combination is capable of retrieving
polyps, we conclude that the proposed combination intends to add
Levinson’s end effector (second set of wires 28) to Konomura’s end effector
(basket 3 comprised of wires 6).
The Examiner’s finding that the combined Levinson and Konomura
end effector is an end effector consisting essentially of a snare loop, as
called for in independent claims 1, 34, 47, and 59, fails to address the
requirement in the claims that elements other than the snare loop that are
included in the end effector may not materially affect fluid communication
between the lumen and the outside of the lumen. Appellant argues that the
combined end effector of Konomura and Levinson would inhibit the basic
and novel characteristic of the claimed device for the flow path to permit
fluid communication between the lumen and the outside of the lumen. App.
Br. 16-19. Given that the proposed combination increases the elements in
the flow path through the lumen, and the absence of a finding on this issue
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by the Examiner, we cannot conclude that the proposed combination meets
the contested claim limitation by a preponderance of the evidence.
Rejection of claims 5-7 under 35 U.S.C. § 103(a) as being unpatentable over
Konomura, Levinson, and McAlister
Claims 5-7 depend indirectly from claim 1. The Examiner’s rejection
of claims 5-7 uses the same end effector as explained in the analysis of the
first rejection supra. The additional proposed modification as taught by
McAlister is unrelated to the end effector. Consequently, we cannot sustain
the rejection of claims 5-7 as it suffers from the same shortcoming as the
rejection of independent claim 1 supra.
Rejection of claims 69-75, 81, 82, 89, 93, and 101 under 35 U.S.C. § 103(a)
as being unpatentable over Konomura, Levinson, and Okada
Independent claim 69 is directed to a medical device that includes a
distal member having a flow path wherein at least a portion of the flow path
has a cross-sectional flow area smaller than both a cross-sectional flow area
of an inlet of the flow path and a cross-sectional flow area of an outlet of the
flow path. Claim 89 depends from independent claim 47, and claim 93
depends from independent claim 59. Claims 89 and 93, like independent
claim 69, each contain the limitation that the distal member has a flow path
wherein at least a portion of the flow path has a cross-sectional flow area
smaller than both a cross-sectional flow area of an inlet of the flow path and
a cross-sectional flow area of an outlet of the flow path.
Appellant argues that the Examiner did not provide a sufficient reason
to combine the references as proposed. App. Br. 25-27. We agree.
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Okada discloses a twenty-first embodiment of a video endoscopic
system 301 that comprises a video endoscope 302 that includes a washing
nozzle 372 mounted on the rounded distal end 371. Okada, col. 20, ll. 20-
21; col. 22, ll. 56-65; fig. 30B. Okada’s washing nozzle 372 is bent to
provide cleaning fluid to the foremost lens 328a of the observation lens unit
322 of the video endoscope 302. Okada, col. 22, l. 66 – col. 23, l. 4; figs.
30A, 30B. Okada makes no disclosure relating to the control, accuracy, or
efficiency of fluid provided by washing nozzle 372. Okada, passim. Thus,
we fail to find a rational underpinning for the Examiner’s conclusion that
use of Okada’s washing nozzle 372 would provide greater control over the
outlet flow path, or greater accuracy and efficiency when delivering fluids.
See Ans. 9, 11-12.
Consequently, we cannot sustain the rejection of independent claim 69
or of dependent claims 89 and 93. Further, we also cannot sustain the
rejection of claims 70-75, 81, 82, and 101, which depend from independent
claim 69, as their rejection suffers from the same shortcoming.
Rejection of claims 87, 88, and 102 under 35 U.S.C. § 103(a) as being
unpatentable over Konomura, Levinson, and Termanini
Independent claim 87 is directed to a medical device including a distal
member that defines a flow path comprising an inlet and a plurality of
outlets connecting to the inlet.
Appellant argues that the Examiner did not provide a sufficient reason
to combine the references as proposed. App. Br. 29-31. We agree.
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Termanini discloses “a fiber-optic catheter system . . . adapted for
visual inspection of the intra-cardiovascular system” that injects clear
solution into the bloodstream to reduce the opacity of the blood in order to
improve visibility. Termanini, col. 1, ll. 38-57. Termanini discloses that the
clear solution is injected into the bloodstream from the apertures 40 of head
36. Termanini, col. 4, ll. 38-39; figs. 1, 3, 6. Termanini discloses that a
single aperture 40 may be employed. Termanini, col. 3, ll. 41-44.
Termanini makes no disclosure related to the control over the output of fluid
provided by the apertures 40 of head 36. Termanini, passim. Thus, we fail
to find a rational underpinning for the Examiner’s conclusion that use of
Termanini’s head 36 having aperture(s) 40 provides “greater control over the
outputted flow of fluid.” See Ans. 10.
We therefore cannot sustain the rejection of independent claim 87.
Further, we cannot sustain the rejection of claims 88 and 102, which depend
from independent claim 87, as their rejection suffers from the same
shortcoming.
CONCLUSIONS
The disclosures of Konomura and Levinson would not have led a
person of ordinary skill in the art to an end effector consisting essentially of
a snare loop as called for in independent claims 1, 34, 47, and 59.
The Examiner did not articulate a sufficient reason with rational
underpinning to explain why a person having ordinary skill in the art would
have been led to modify the flow path of Konomura in light of the teaching
of Okada so that a portion of the flow path has a cross-sectional flow area
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smaller than both a cross-sectional flow area of an inlet and a cross-sectional
flow area of an outlet of the flow path, to arrive at the invention of claims
69, 89, and 93.
The Examiner did not articulate a sufficient reason with rational
underpinning to explain why a person having ordinary skill in the art would
have been led to modify the flow path of Konomura in light of the teaching
of Termanini so that the flow path comprises an inlet and a plurality of
outlets connecting to the inlet, to arrive at the invention of claim 87.
DECISION
We REVERSE the Examiner’s decision to reject claims 1-7, 10-18,
28-37, 39, 40, 43-53, 56, 58-64, 66, 67, 69-75, 81, 82, 87-89, 93, and 97-
102.

REVERSED

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