Ex Parte Strommer et al

Board of Patent Appeals and Interferences

Jul 19, 2012

11233420 (B.P.A.I. Jul. 19, 2012)

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.
11/233,420 09/16/2005 Gera Strommer 0K-040320US
(065513-0263)
8956
67337 7590 07/19/2012
SJM/AFD - DYKEMA
c/o CPA Global
P.O. Box 52050
Minneapolis, MN 55402
EXAMINER
SANTOS, JOSEPH M
ART UNIT PAPER NUMBER
3737
MAIL DATE DELIVERY MODE
07/19/2012 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 GERA STROMMER and UZI EICHLER
__________

Appeal 2011-006434
Application 11/233,420
Technology Center 3700
__________

Before MELANIE L. McCOLLUM, STEPHEN WALSH, and
ERICA A. FRANKLIN, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to methods for delivering a medical device coupled with a
catheter, and systems for delivering a medical device to a selected position
within a body lumen of a patient. The Patent Examiner rejected the claims
for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
Appeal 2011-006434
Application 11/233,420

2
STATEMENT OF THE CASE
Claims 1-47 are on appeal. Claim 1 is illustrative and reads as follows
(emphasis added):
1. Method for delivering a medical device coupled with a catheter, to a
selected position within a lumen of the body of a patient, the method
comprising the procedures of:
registering a three-dimensional coordinate system with a two-
dimensional coordinate system, said three-dimensional coordinate system
being associated with a medical positioning system (MPS), said two-
dimensional coordinate system being associated with a two-dimensional
image of said lumen, said two-dimensional image being further associated
with an organ timing signal of an organ of said patient;
acquiring MPS data respective of a plurality of points within said
lumen, each of said points being associated with said three-dimensional
coordinate system, each of said points being further associated with a
respective activity state of said organ;
determining a temporal three-dimensional trajectory representation for
each said respective activity states from said acquired MPS data which is
associated with said respective activity state; and
superimposing said temporal three-dimensional trajectory
representations on said two-dimensional image, according to said respective
activity state,
receiving position data respective of said selected position, by
selecting at least one of said points along said temporal three-dimensional
trajectory representation;
determining the coordinates of said selected position in said three-
dimensional coordinate system, from said selected at least one point;
producing a real-time navigation image of said lumen, said real-time
navigation image being associated with said three-dimensional coordinate
system, said real-time navigation image including a real-time medical device
image of a medical device, located at the tip of a catheter, which is being
maneuvered within said lumen; and
superimposing a representation respective of said selected position, on
said real-time navigation image, thereby enabling an operator to visually
navigate said medical device toward said selected position.

Appeal 2011-006434
Application 11/233,420

3
The Examiner rejected the claims as follows:
 claims 1-18, 20, 22-44, 46, and 47 under 35 U.S.C. § 103(a) as
unpatentable over Simon,1 Schweikard,2 and Ben-Haim;3
 claims 19 and 45 under 35 U.S.C. § 103(a) as unpatentable over
Simon, Schweikard, Ben-Haim, and Dickinson;4 and
 claim 21 under 35 U.S.C. § 103(a) as unpatentable over Simon,
Schweikard, Ben-Haim, and Panescu.5

OBVIOUSNESS
Appellants contend that the rejection of claim 1 should be reversed
because the claimed method includes numerous steps and limitations not
disclosed or suggested by the combination of Simon, Schweikard, and Ben-
Haim. (App. Br. 11-12, listing seven steps.) For example, Appellants
contend that
Simon et al. does not disclose or suggest acquiring positional data
from within a lumen, nor the use of a catheter. The disclosure in
Simon et al. is instead focused on the use of medical instruments for
diagnosis and treatment of bone (see, e.g., Figs. 5A-5B) such as a drill
and nowhere discloses or suggests tracking a device passed through a
lumen in the body nor, in particular, a medical device attached to a
catheter. For similar reasons, Simon et al. does not disclose or suggest
“producing a real-time navigation image of said lumen ... said real-
time navigation image including a real-time medical device image of a
medical device, located at the tip of a catheter, which is being

1 David A. Simon et al., US 6,470,207 B1, filed March 23, 1999.
2 Achim Schweikard et al., US 6,501,981 B1, effective filing date March 16,
1999.
3 Shlomo Ben-Haim et al., US 2001/0044578 A1, filed Jan. 22, 1998.
4 Robert Julian Dickinson et al., US 6,275,724 B1, filed Nov. 13, 1998.
5 Dorin Panescu et al., US 5,740,808, April 21, 1998.
Appeal 2011-006434
Application 11/233,420

4
maneuvered within said lumen” as recited in claim 1 (emphasis
added).

(Id. at 14.)
The rejection did not provide evidence that Simon, Schweikard, or
Ben-Haim described a system that acquired and displayed images of a lumen
or a catheter in a lumen. The Answer did not explain how the evidence
deficit could be rationalized. The rejection of claim 1 is reversed. See In re
Warner, 379 F.2d 1011, 1017 (CCPA 1967) (“we may not resolve doubts in
favor of the Patent Office determination when there are deficiencies in the
record as to the necessary factual bases supporting its legal conclusion of
obviousness”).
Regarding the separate rejection of claims 19 and 45, Appellants
again argue that the combination of references does not disclose or suggest
all the limitations recited in the claims. (App. Br. 42-43.) The rejection of
claim 19 added Dickinson’s disclosure of a “system and method for
ultrasonic imaging in particular a system which utilize[s] a catheter
insertable into a patient and carrying an ultrasonic transducer array,” and
concluded it would have been obvious “to modify the invention of Simon et
al. in view of Schweikard et al. in further view of Ben-Haim et al. to acquire
intravascular ultrasound images in order to provide a three-dimensional
representation of the inside of the lumen.” (Ans. 6-7.) The Dickinson
finding is undisputed, but we agree with Appellants that, without more, the
rejection still did not explain how the combined teachings suggested all the
limitations of the systems defined in claims 19 and 45. The rejection of
claims 19 and 45 is reversed.
Appeal 2011-006434
Application 11/233,420

5
Regarding the separate rejection of system claim 21, Appellants again
argue that the combination of references does not disclose or suggest all the
limitations recited in the claims. (App. Br. 42-43.) The rejection of claim
21 added Panescu’s disclosure, “a radio-opaque marker is placed at the distal
end of a insertable medical guide,” and concluded that it would have been
obvious “to expand the system and methods Simon et al. in view of
Schweikard et al. in further view of Ben-Haim et al. to include radio-opaque
markers in the distal end of the catheter in order to enhance medical
procedures as endocardial ablation by position [sic] the ablation electrodes
inside the patient.” (Ans. 7.) This rejection seems to assume that Simon,
Schweikard, and Ben-Haim described a system using a catheter in a lumen,
but the rejection failed to establish that point. Panescu’s opaque marker at
the end of a catheter is not enough to bridge the gap between the combined
reference teachings and all the other claim limitations. The rejection of
claim 21 is reversed.
SUMMARY
We reverse the rejection of claims 1-18, 20, 22-44, 46, and 47 under
35 U.S.C. § 103(a) as unpatentable over Simon, Schweikard, and Ben-Haim.
We reverse the rejection of claims 19 and 45 under 35 U.S.C. § 103(a)
as unpatentable over Simon, Schweikard, Ben-Haim, and Dickinson.
We reverse the rejection of claim 21 under 35 U.S.C. § 103(a) as
unpatentable over Simon, Schweikard, Ben-Haim, and Panescu.

REVERSED
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