Ex Parte Viswanathan et al

Patent Trial and Appeal Board

Nov 12, 2014

11685664 (P.T.A.B. Nov. 12, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte RAJU R. VISWANATHAN, WALTER M. BLUME,
OREN LIAV, ZAFRIR PATT, and ASSAF RUBISSA
__________

Appeal 2012-004760
Application 11/685,664
Technology Center 3700
__________

Before LORA M. GREEN, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
for navigating a medical device within a subject’s body with a magnetic
navigation system and an electromagnetic localization system. The
Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.

1 Appellants identify the Real Party in Interest as Stereotaxis, Inc.
(see App. Br. 2).
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Statement of the Case
Background
“Medical procedures such as minimally interventional diagnosis and
treatment of cardiac arrhythmias in electrophysiology often involve steering
a localized medical device such as a catheter within anatomical regions in
order to create a geometrical representation or map of the anatomical
chamber of interest” (Spec. 1 ¶ 3).
The Claims
Claims 1–20 are on appeal. Independent claim 1 is representative and
reads as follows:
1. A method for navigating a medical device within a
subject’s body with a magnetic navigation system and an
electromagnetic localization system, the method comprising:
importing three-dimensional pre-operative anatomical
surface data of an anatomical surface within a subject’s body
into a localization system for monitoring spatial location of a
medical device navigable by a magnetic navigation system
spatially registered with the localization system;
applying one or more navigational control parameters
to the magnetic navigation system for driving the medical
device relative to the imported pre-operative anatomical
surface data to one or more points of contact with the actual
anatomical surface within the subject’s body;
for each of the one or more points of contact,
identifying a three-dimensional location and sensing
electrical activity;
creating a geometric anatomical map from the one or
more three-dimensional locations and sensed electrical
activity associated with the one or more points of contact;
registering the geometric anatomical map with the
pre-operative anatomical surface data;
selecting at least one desired location from the pre-
operative anatomical surface data and using localization
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system data to provide location data to the magnetic
navigation system for driving the medical device to the at
least one desired location; and
updating the geometric anatomical map to include
sensed electrical activity and at least one three-dimensional
location associated with the at least one desired location.

The Issue
The Examiner rejected claims 1–20 under 35 U.S.C. § 103(a) as being
obvious over Reisfeld2 and Garibaldi3 (Ans. 4–7).
The Examiner finds that Reisfeld teaches:
[A] method for cardiac mapping including an imaging
device with a catheter device for application within a
subjects heart, where the catheter uses a coordinate sensor
with coils for electromagnetic positioning for tracking
position and orientation information and is controllably
driven within the cavity to a first and further points of
contact for a 3D map and sensed electrical activity, and used
with external information for making contact with the
anatomical surface, and further the points of contact are
iteratively registered/matched for updating to the points of
the anatomical surface (see columns 1 (lines 11- 38), 2 (lines
7-51), 3 (lines 1-64), 5 (lines 19-67), 11 (lines 41-67), 12
(lines 1-67), 16 (lines 1-67)).

(Ans. 4–5.) The Examiner finds that “Reisfeld fails to discuss a medical
device navigable by a magnetic navigation system spatially registered with
the localization system. Importantly, Reisfeld discloses sensing electrical
activity” (Ans. 5).

2 Reisfeld, D., US 6,301,496 B1, issued Oct. 9, 2001.
3 Garibaldi et al., US 2002/0116043 A1, published Aug. 22, 2002.
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The Examiner finds that “Garibaldi discloses a magnetically navigated
pacing lead that is positioned using a magnetic system that is registered to
images of the subject for the purpose of reducing the time of a mapping
procedure and for reducing the difficulty of such a procedure (see para
[0003]-[0004] and para [0057])” (Ans. 5).
The Examiner finds it obvious to
[C]ombine the method of Reisfeld with the further teachings
of Garibaldi because doing so would expedite the mapping
process, thus improving outcomes for injured patients and
because doing so would reduce the difficulty of the
procedure freeing the physician to do other procedures and
reducing the risks of human error

(Ans. 5).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Reisfeld and Garibaldi render the
claims obvious?
Findings of Fact
1. Reisfeld teaches that “a map of a reconstructed volume in a
patient is used as a beginning curve for subsequent mapping procedures
performed at later times on the same volume” (Reisfeld, col. 3, ll. 54–56).
2. Reisfeld teaches that in “order to allow the surgeon to
appreciate the determined data, a map, preferably a three dimensional (3D)
map, including the sampled points is produced” (Reisfeld, col. 1, ll. 29–31).
3. Reisfeld teaches that “a processor reconstructs a 3D map of a
volume or cavity in a patient’s body (hereinafter referred to as the volume),
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from a plurality of sampled points on the volume whose position coordinates
have been determined” (Reisfeld, col. 3, ll. 1–5).
4. Reisfeld teaches that when “the reconstruction is finished, each
sampled point substantially coincides with a grid point. In some preferred
embodiments of the present invention, a final exact matching stage is
performed. Each sampled point is associated with a closest grid point, and
the associated grid point is moved onto the sampled point” (Reisfeld, col. 5,
ll. 19–24).
5. Reisfeld teaches that “the coordinates of the points and,
optionally, values of one or more physiological parameters are sensed at a
distal end of the catheter. . . . Preferably, the coordinate sensor determines
the position by transmitting and receiving electromagnetic waves” (Reisfeld,
col. 5, ll. 47–54).
6. Reisfeld teaches
[R]econstructing a map of a volume from coordinates of a
plurality of determined locations on a surface of the volume
having a configuration, including a processor, which
receives the coordinates and generates a grid of points
defining a reconstruction surface in 3D space in proximity to
the determined locations, and which defines a respective
vector for each of the points on the grid, dependent on a
displacement between one or more of the points on the grid
and one or more of the locations, and which adjusts the
reconstruction surface by moving each of the points on the
grid responsive to the respective vector, so that the
reconstruction surface is deformed to resemble the
configuration of the surface of the volume.

(Reisfeld, col. 11, ll. 41–54.)
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7. Reisfeld teaches that “the probe includes a functional portion
for acquiring a value of a physiological activity at the plurality of locations.
Preferably, the functional portion includes an electrode” (Reisfeld, col. 12,
ll. 64–67).
8. Reisfeld teaches that:
Distal end 22 of catheter 20 further includes a device
28 that generates signals used to determine the position and,
preferably, orientation of the catheter within the body.
Device 28 is preferably adjacent to functional portion 24, in
a fixed relation with tip 26. Device 28 preferably comprises
three non-concentric coils . . . .This device enables
continuous generation of six dimensions of position and
orientation information with respect to an externally-applied
magnetic field.

(Reisfeld, col. 16, ll. 25–34.)
9. Reisfeld teaches that
The present invention allows the measurement of LAT,
relative to the cardiac cycle, at a plurality of sampled points
on the inner surface of a chamber of the heart, using a
device, at the tip of a catheter, that senses electrical activity
only at a single point of contact of the catheter tip with the
inner surface of the chamber of the heart. These
measurements of LAT are posted at corresponding points on
a grid that corresponds to a particular time in the cardiac
cycle

(Reisfeld, col. 8, ll. 12–19.)
10. Reisfeld teaches that once the “conduction velocity vectors . . .
are displayed superimposed on the 3D map of the surface of the heart,
treatment may be administered to those areas of the heart depicted as being
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problematic based on the displayed velocity vectors. For instance, ablative
treatment is administered at those areas depicting velocity vector direction”
(Reisfeld, col. 28, ll. 11–16).
11. Garibaldi teaches that:
The present invention provides a method and
apparatus for guiding medical devices into human blood
vessels. It is particularly useful for the placement of pacing
leads and delivery catheters for facilitating the placement of
the leads, and improved methods of placing the leads that
make the procedures easier for the physicians to perform,
and shorter for the patients. This reduces the stress of the
procedure on the patient, and shortens recovery time.

(Garibaldi 1 ¶ 4.)
12. Garibaldi teaches that a
[U]ser interface, using bi-planar fluoroscopic imaging,
allows the physician to quickly indicate the desired direction
on two two-dimensional images, which a computer can
translate the selection to a direction in three dimensional
space and control an external magnet (which may be a
permanent magnet or magnets, an electromagnet or
electromagnets, or a superconducting electromagnet or
superconducting electromagnet) to apply the appropriate
magnetic field. Once the magnet properly orients the
device, the device can be advanced using an automatic
advancer, or if the magnet is capable of generating a
sufficient gradient, using the external magnets.

(Garibaldi 6 ¶ 57.)
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
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ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 4–7; FF 1–11) and agree that the
claims are obvious over Reisfeld and Garibaldi. We address Appellants’
arguments below.
Appellants contend that:
Examiner’s analysis of Reisfeld and Garibaldi does
not point to any disclosure of:
• importing three-dimensional pre-operative
anatomical surface data of an anatomical surface within a
subject’s body into a localization system for monitoring
spatial location of a medical device navigable by a magnetic
navigation system spatially registered with the localization
system
• applying one or more navigational control
parameters to the magnetic navigation system for driving
the medical device relative to the imported pre-operative
anatomical surface data to one or more points of contact
with the actual anatomical surface within the subject’s body

(App. Br. 9). Appellants also contend that “the Examiner has not articulated
a sufficient reason why one skilled in the art would have modified Reisfeld
or Garibaldi’s teaching to arrive at the presently claimed methods” (App.
Br. 10).
We are not persuaded. Reisfeld teaches beginning with a map of the
patient (FF 1). Reisfeld teaches constructing a 3D map of a patient body
cavity (FF 3) in “order to allow the surgeon to appreciate the determined
data” (Reisfeld, col. 1, ll. 29–30; FF 2). Reisfeld teaches that this 3D map is
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generated using “a grid of points defining a reconstruction surface in 3D
space in proximity to the determined locations” (Reisfeld, col. 11, ll. 45–47;
FF 6). Reisfeld teaches a medical device, specifically a catheter, whose
position may be monitored by a localization system, where the “catheter 20
further includes a device 28 that generates signals used to determine the
position and, preferably, orientation of the catheter within the body . . . .
This device enables continuous generation of six dimensions of position and
orientation information with respect to an externally-applied magnetic field”
(Reisfeld, col. 16, ll. 25–34; FF 8).
The only claim element absent from Reisfeld, as acknowledged by the
Examiner, is “that Reisfeld proceeds as follows: a user reads information
displayed by the system, determines a location of the device and a new
desired location, and moves the catheter to the desired location” (Ans. 10).
As the Examiner notes, this differs from claim 1 because Reisfeld does not
expressly teach driving the navigation using a magnetic navigation system
(see Ans. 5, 10).
Garibaldi teaches that once “the magnet properly orients the device,
the device can be advanced using an automatic advancer, or if the magnet is
capable of generating a sufficient gradient, using the external magnets”
(Garibaldi 6 ¶ 57; FF 12).
We agree with the Examiner’s reasoning (see Ans. 8–9) that it would
have been obvious to modify Reisfeld’s three dimensional tracking process
to utilize Garibaldi’s magnetic orientation and advancement because
Garibaldi’s method is
particularly useful for the placement of pacing leads
and delivery catheters for facilitating the placement of the
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leads, and improved methods of placing the leads that make
the procedures easier for the physicians to perform, and
shorter for the patients. This reduces the stress of the
procedure on the patient, and shortens recovery time.

(Garibaldi 1 ¶ 4; FF 11.)
Appellants contend that “there is no apparent reason why a skilled
artisan would have deviated from the References and modified them in a
manner that would result in the . . . claimed methods” (App. Br. 13).
We are not persuaded. As discussed above, Reisfeld teaches mapping
the heart first, after which treatment is applied to problematic areas (FF 10).
The ordinary artisan, interested in most efficiently delivering Reisfeld’s
treatment device to the desired location, would have utilized the automated
magnetic navigation method of Garibaldi for the multiple motivations
expressly provided by Garibaldi (FF 11), utilizing the map generated by
Reisfeld to provide the specific location for treatment (FF 10).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Reisfeld and Garibaldi render the claims obvious.
SUMMARY
In summary, we affirm the rejection of claims 1 and 11 under
35 U.S.C. § 103(a) as being obvious over Reisfeld and Garibaldi. Pursuant
to 37 C.F.R. § 41.37(c), we also affirm the rejection of claims 2–10 and 12–
20, as these claims were not argued separately.

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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

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