Ex Parte Hogg et al

Board of Patent Appeals and Interferences

May 31, 2011

10674914 (B.P.A.I. May. 31, 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.
10/674,914 09/30/2003 Bevil J. Hogg 5236-000452 8982
28997 7590 05/31/2011
HARNESS, DICKEY, & PIERCE, P.L.C
7700 Bonhomme, Suite 400
ST. LOUIS, MO 63105
EXAMINER
NGUYEN, HUONG Q
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
05/31/2011 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 BEVIL J. HOGG, JEFFREY M. GARIBALDI, and
RAJU R. VISWANATHAN
____________________

Appeal 2010-001453
Application 10/674,914
Technology Center 3700
____________________

Before: STEVEN D.A. McCARTHY, KEN B. BARRETT, and
PHILLIP J. KAUFFMAN, Administrative Patent Judges.

KAUFFMAN, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2010-001453
Application 10/674,914
2
STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
6, 8-17, 38-40, and 52.
1
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

THE INVENTION
Appellants‟ claimed invention relates to “the use of electronic
identifiers with automatically actuated flexible medical devices for
controlling the distal end of an elongate medical device for efficient surgical
navigation and target access.” Spec. 1, para. [0002]. Claim 1, reproduced
below, is illustrative of the claimed subject matter:

1
Claim 51 is not before us on appeal as it was not rejected in the Office
Action that is the subject of this appeal. See Office Action, dated December
10, 2008, pp. 1, 3 (cover page erroneously lists claim 51 as rejected;
however the body makes clear that claim 51 is not rejected but is subject to
an objection); see also App. Br. 2, 26 (stating that claim 51 should be treated
as cancelled). The claims as set forth in the Appellants‟ Evidence Appendix
appear to correspond to those on file as of January 9, 2008, the date of the
last Amendment entered by the Examiner. The Appellants filed an
Amendment on March 10, 2009. The Amendment stated that, “[i]n the
event that the Office denies entry of Applicants‟ January 20, 2008
Supplemental Appeal Brief requesting reinstatement of the appeal, the
Applicants respectfully request entry of this Response to the December 10,
2008 Office Action, which Response includes arguments presented in
Applicants‟ Supplemental Appeal Brief.” Amendment dated March 10,
2009 at 1. The record does not indicate whether the Examiner considered
the March 10, 2009 Amendment. Even assuming that the Examiner did not
consider the March 10, 2009 Amendment, the only change which the
Amendment proposed to make to the claims was to cancel claim 51. Since
the entry of the Amendment would not have changed the issues in this
appeal, we will decide the appeal on the basis of the claims as set forth in the
Appellants‟ Claims Appendix.
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1. A medical navigation system for controlling the distal
end of an elongate flexible medical device in a subject's body,
the system comprising:
an elongate flexible medical device having on its distal
end portion one or more magnetically responsive elements that
respond to an externally applied magnetic field to change the
direction of the distal end of the medical device, and an
electronic identification device on the elongate medical device
that includes information on the physical and geometric
properties of the elongate medical device including the number
of magnetically responsive elements and spacing therebetween,
and identification information that provides for elongate
flexible medical device identification;
a navigation device configured to create a magnetic field
used to steer the elongate flexible medical device, and to
determine, as a function of the physical and geometric
properties, actuation control variables for an applied actuation
consisting essentially of an external magnetic field, where the
navigation device determines and applies an appropriate
magnetic field direction for actuating the distal end of an
elongate flexible medical device and thereby changing its
orientation;
an electronic interface for selectively operating the
navigation device for selectively controlling the orientation of
the distal end of the elongate flexible medical device, the
electronic interface comprising a processor and at least one
software program that enables navigation control only in the
presence of the electronic identification device, wherein the
interface provides actuation instructions to the navigation
device for controlling the distal end of the device, which
instructions take into account the physical and geometric
properties of the elongate medical device, including the number
of magnetically responsive elements and, spacing therebetween,
that were obtained from the electronic identification device.

Appeal 2010-001453
Application 10/674,914
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THE REJECTIONS
Appellants seek review of the following rejections:
1. Rejection of claims 1-6, 8, 9, 11-17, and 52 under 35 U.S.C. § 103(a)
as being unpatentable over Stereotaxis (WO 00/07641; published February
17, 2000) and Osadchy (US 6,266,551 B1; issued July 24, 2001).
2. Rejection of claim 10 under 35 U.S.C. § 103(a) as being unpatentable
over Stereotaxis, Osadchy, and Burnside (US 6,237,604 B1; issued May 29,
2001).
3. Rejection of claims 38-40 under 35 U.S.C. § 103(a) as being
unpatentable over Stereotaxis, Garibaldi (US 6,401,723 B1; June 11, 2002),
and Osadchy.

CONTENTIONS AND ISSUES
Regarding the first rejection, Appellants argue claims 1-6, 8, 9, and
11-17 as a group. App. Br. 20. We select claim 1 as the representative
claim, and claims 2-6, 8, 9, and 11-17 stand or fall with claim 1. See 37
C.F.R. § 41.37(c)(1)(vii).
The Examiner found that Osadchy discloses an electronic
identification device (digital microcircuit 90) on an elongate medical device
(catheter 20) that includes information on the physical and geometric
properties of the elongate medical device, including the number of
magnetically responsive elements (coils 60, 62, 64) and the spacing between
those elements (displacements dy and dz). Ans. 4, 8-9, 11.
Appellants present two arguments against the Examiner‟s rejection of
claim 1. First, Appellants contend, “Osadchy‟s distance L is merely used as
an offset to calibrate the determination of the actual position of the tip of a
particular catheter,” and does not take into account information on the
Appeal 2010-001453
Application 10/674,914
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number of magnetically responsive elements and the spacing between those
elements. App. Br. 14. For that reason, Appellants assert the proposed
combination would not result in the subject matter of claim 1, and thus the
Examiner has not articulated a sufficient reason for the proposed
modification. App. Br. 14-15; Reply Br. 2-3. Second, Appellants contend
that Osadchy teaches away from the proposed combination because a person
having ordinary skill in the art would have modified Stereotaxis‟s system to
include a calibration offset, based on the distance L, as taught by Osadchy,
and in doing so would not have arrived at the subject matter of claim 1.
App. Br. 15-16; Reply Br. 2-3.
The first issue is whether the proposed combined teachings of
Stereotaxis and Osadchy would have rendered the subject matter of
independent claim 1 obvious to a person having ordinary skill in the art.
Independent claim 38 calls for a memory device on a flexible medical
device that includes information on the physical and geometric properties of
that device, including one or more cross-sectional areas of the elongate
device and an elastic property of the elongate medical device.
The Examiner found that Garibaldi teaches that the cross-sectional
area of the coil wire of an analogous elongate medical device is directly
proportional to the magnetic moment of the coil, which in turn is directly
proportional to the magnetic torque applied to the distal end of the elongate
medical device. Ans. 11 (citing Garibaldi, col. 4, ll. 36-42). The Examiner
concluded that it would have been obvious to modify Stereotaxis‟s device
“such that one or more cross-sectional areas of the elongate device are used
in navigational control algorithms for guiding the device as taught by
Garibaldi et al to effectively take into account the effect of the cross-
sectional area on the magnetic torque of the elongate medical device.” Id.
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Appellants contend that Garibaldi discloses a teaching related to the
cross-sectional area of a coil within a medical device, but does not disclose
use of information regarding the cross-sectional area of the medical device
for navigational control of the device. Reply Br. 5.
The second issue is whether the proposed combination of Stereotaxis,
Osadchy, and Garibaldi would have led a person of ordinary skill in the art
to the subject matter of independent claim 38.

ANALYSIS
Rejection of claims 1-6, 8, 9, 11-17, and 52 under 35 U.S.C. § 103(a) as
being unpatentable over Stereotaxis and Osadchy
Claims 1-6, 8, 9, 11-17
Appellants argument that Osadchy merely discloses an offset
calibration based on the distance L does not address the Examiner‟s finding
that Osadchy‟s coils 60, 62, 64 correspond to the claimed magnetically
responsive elements, and that Osadchy‟s displacements dy and dz correspond
to the spacing between those elements. See App. Br. 13-16; Reply Br. 2-3;
Ans. 4. Because Appellants fail to address the rejection as articulated by the
Examiner, we are unpersuaded by Appellants‟ assertion that the Examiner
erred.
Further, even assuming, arguendo, Appellants are correct that a
person of ordinary skill in the art would have modified Stereotaxis‟s system
to include a calibration offset (based on the distance L) for the elongate
medical device tip as taught by Osadchy, Appellants‟ argument does not
convincingly explain how such a modification would have led a person of
ordinary skill in the art in a direction divergent from modifying Stereotaxis‟s
system so that the electronic identification device includes information on
Appeal 2010-001453
Application 10/674,914
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the physical and geometric properties of the elongate medical device,
including the number of magnetically responsive elements (coils 60, 62, 64)
and the spacing between those elements (displacements dy and dz). See In re
Haruna, 249 F.3d 1327, 1335 (Fed. Cir. 2001) (“„A reference may be said to
teach away when a person of ordinary skill, upon reading the reference, . . .
would be led in a direction divergent from the path that was taken by the
applicant.‟” (citation omitted)). In other words, assuming, arguendo, a
person of ordinary skill in the art would have modified Stereotaxis‟s system
to include a calibration offset as taught by Osadchy, that does convincingly
explain why a person of ordinary skill in the art would not have found it
obvious to modify Stereotaxis‟s system to include information on the
physical and geometric properties of the elongate medical device as taught
by Osadchy.
As such, we sustain the rejection of claim 1, and claims 2-6, 8, 9, and
11-17 fall with claim 1.
Claim 52
Independent claim 52, similarly to independent claim 1, calls for a
memory device that includes information on the physical and geometric
properties of the elongate medical device. The rejection of claim 52, like the
rejection of claim 1, relies upon Osadchy as disclosing this limitation. Ans.
8-9. Appellants repeat the arguments used against the rejection of
independent claim 1. App. Br. 17-20. We find no distinction in independent
claim 52 warranting a deviation from our analysis of claim 1, supra, and
thus, we sustain the rejection of independent claim 52.

Appeal 2010-001453
Application 10/674,914
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Rejection of claim 10 under 35 U.S.C. § 103(a) as being unpatentable over
Stereotaxis, Osadchy, and Burnside
Claim 10 depends from independent claim 1. The rejection of claim
10 relies upon the same finding as claim 1 that Osadchy discloses an
electronic identification device that includes information on the physical and
geometric properties of the elongate medical device including the number of
magnetically responsive elements and spacing between those elements. Ans.
9-10 (referring to Ans. 3-5). Appellants contend that claim 10 is allowable
by virtue of its dependence from claim 1. App. Br. 21; Reply Br. 4. For the
reasons explained in the analysis of claim 1, supra, we sustain the rejection
of claim 10.

Rejection of claims 38-40 under 35 U.S.C. § 103(a) as being unpatentable
over Stereotaxis, Garibaldi, and Osadchy
Garibaldi discloses a magnetic medical device with changeable
magnetic moments and methods of navigating such devices. Garibaldi, col.
1, ll. 9-12. Garibaldi discloses that the magnetic torque on the distal end of
the catheter is directly proportional to the magnetic moment of the magnetic
medical device and the applied navigating magnetic field. Garibaldi, col. 4,
ll. 36-39. Garibaldi further discloses that, “for a coil, the magnetic moment
is directly proportional to the product of the number of turns in the coil, the
current through the coil, and the cross-sectional area of the coil wire.”
Garibaldi, col. 4, ll. 39-42. Garibaldi does not disclose a relationship
between the magnetic moment of the magnetic medical device and the cross-
sectional area of the magnetic medical device. Garibaldi, passim.
Consequently, Garibaldi discloses that the cross-sectional area of the
coil of wire within a flexible medical device (e.g., a catheter) is related to the
Appeal 2010-001453
Application 10/674,914
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magnetic moment of a coil of such wire, but Garibaldi does not disclose a
relationship between the magnetic moment of a flexible medical device and
the cross-sectional area of that device. Since Garibaldi does not disclose a
relationship between the magnetic moment of a flexible medical device and
the cross-sectional area of that device, Garibaldi fails to demonstrate that
one of ordinary skill in the art would have recognized the cross-sectional
area of the device as a variable directly bearing on the magnetic field
required to effect a desired torque in the device. Hence, Garibaldi does not
disclose a memory device on a flexible medical device that includes
information on one or more cross-sectional areas of the elongate device as
called for in independent claim 38. Given this, we fail to see, and the
Examiner has failed to convincingly articulate how a person of ordinary skill
in the art would have been led to the subject matter of independent claim 38.
We do not sustain the rejection of independent claim 38, or its
dependent claims 39 and 40.

CONCLUSIONS OF LAW
The proposed combined teachings of Stereotaxis and Osadchy would
have rendered the subject matter of independent claim 1 obvious to a person
having ordinary skill in the art.
The proposed combination of Stereotaxis, Osadchy, and Garibaldi
would not have led a person of ordinary skill in the art to the subject matter
of independent claim 38.

Appeal 2010-001453
Application 10/674,914
10
DECISION
We affirm the Examiner‟s decision to reject claims 1-6, 8, 9, 11-17,
and 52 under 35 U.S.C. § 103(a) as being unpatentable over Stereotaxis and
Osadchy.
We affirm the Examiner‟s decision to reject claim 10 under
35 U.S.C. § 103(a) as being unpatentable over Stereotaxis, Osadchy, and
Burnside.
We reverse the Examiner‟s decision to reject claims 38-40 under
35 U.S.C. § 103(a) as being unpatentable over Stereotaxis, Garibaldi, and
Osadchy.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART

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