Ex Parte Cohen

Patent Trial and Appeal Board

Mar 24, 2017

12748894 (P.T.A.B. Mar. 24, 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.
12/748,894 03/29/2010 Amit COHEN 0K-042100US 6106
(065513-0230)
67337 7590 03/28/2017
DYKEMA GOSSETT PLLC (STJ)
4000 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402
EXAMINER
GUPTA, VANI
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
03/28/2017 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):
MN_IPMail @ dykema. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AMIT COHEN
Appeal 2015-007312
Application 12/748,894
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
for tracking a tool relative to a wall of a region of interest of a patient. The
Examiner rejected the claims on the ground of obviousness. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
which is a1 Appellant identifies the Real Party in Interest as Mediguide Ltd.,
subsidiary of St. Jude Medical, Inc. (see App. Br. 1).
Appeal 2015-007312
Application 12/748,894
Statement of the Case
Background
Appellant’s “invention relates generally to a method and related
system for detecting contact with a wall of a region of interest” (Spec. 11).
The Claims
Claims 1—20 are on appeal. Independent claim 1 is representative and
reads as follows (emphasis added):
1. A method for tracking a tool relative to a wall of a
region of interest of a patient, the method comprising:
tracking the motion of the tool, wherein the tool
includes a positioning sensor at a distal end thereof
configured to (i) sense one or more characteristics of a
magnetic field produced by a medical positioning system and
(ii) generate a signal indicative of a sensor position of the
positioning sensor, and creating a tool motion profile
including generating, using the medical positioning system in
response to said signal, the tool position;
calculating a correlation value representative of the
correlation between the tool motion profile and a wall motion
profile indicative of the motion of the wall; and
determining when the correlation value exceeds a
threshold, the correlation value exceeding the threshold being
indicative of contact of the tool with the wall of the region of
interest.
The Issue
The Examiner rejected claims 1—20 under 35 U.S.C. § 103(a) as
obvious over Kesten2 and Kaiser3 (Ans. 2—13).
2 Kesten et al., US 6,493,575 Bl, issued Dec. 10, 2002.
3 Kaiser et al., US 2009/0198298 Al, published Aug. 6, 2009.
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Application 12/748,894
The Examiner finds that Kesten teaches
a method for tracking a tool relative to a wall of a region of
interest of a patient, the method comprising the steps of:
tracking the motion of the tool and creating a tool
motion profile (col. 16,11. 31 — 64; col. 17,11.24—39).
Kesten teaches also using a medical positioning
system, (Abstract: “A catheter tracking system for
visualization of fluoroscopic images . . .”) in response to a
signal generated by the tool (or component of the tool:
“radiopaque markers”) to generate a position of the tool (col.
3,11. 47 — 51; col. 14, line 56 —col. 15, line 8 and col. 16,11.
31 — 38; this includes details of the catheter tracking with use
of this catheter tracking system and radiopaque markers).
Kesten also suggests determining a wall motion profile
indicative of the motion of the wall and (col. 16 line 49-60,
wall motion profile is ECG signal which is indicative of the
motion of the wall) calculating a correlation value
representative of the correlation between the tool motion
profile and a wall motion profile indicative of the motion of
the wall (col. 16,11. 54-64; col. 17,11.2A-39;^s. 10A, 10B,
10C) and determining when the correlation value exceeds a
threshold, the correlation value exceeding the threshold being
indicative of contact of the tool with the wall of the region of
interest (col. 16, line 40 — 64).
(Ans. 2-3.)
The Examiner acknowledges that
Kesten does not [teach] the method as claimed, wherein the
tool includes a positioning sensor at a distal end thereof
configured to (i) sense one or more characteristics of a
magnetic field produced by a medical positioning system and
(ii) generate a signal indicative of a sensor position of the
positioning sensor.
{Id. at 3.)
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Application 12/748,894
The Examiner finds that Kaiser
teaches using a medical position system and tool wherein the
tool includes a position sensor associated with the region of
interest or heart wall that (i) senses one or more characteristics
of a magnetic field produced by the nearby medical position
system ([0029]: “the electromagnetic tracking system 44 can
determine the position of the catheter 52 by measuring the
field strength at the sensor 58 location;” see also paragraphs
[0030 — 0032]) and (ii) generate a signal indicative of a sensor
position of positioning sensor ([0032]: “voltage signals”).
Kaiser’s magnetic-based medical position system works in
conjunction with Kaiser’s fluoroscopic imaging (imaging
device described in [0017]). Kaiser teaches also providing
wall motion data from the position indicating signals ([0032]:
“electromagnetic sensor coil 258R, 25 8L, respectively, which
has been positioned to monitor cardiac wall motion ... as a
result of tracking the sensor coil within the patient during a
cardiac cycle as the heart wall moves . . .”).
{Id. at 3 4.)
The Examiner concludes that it would have been obvious to
modify the medical positioning system and the position
sensor of Kesten with the magnetic field generating and
sensor position sensing capabilities of the medical positioning
system and the position sensor that senses one or more
characteristics of a magnetic field produced by the nearby
medical position system of Kaiser to provide Kesten with
additional means for tracking the distal end of catheter in
approximation with the heart wall, along with the existing
image-guidance means already taught by Kesten.
{Id. at 4.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Kesten and Kaiser render the claims
obvious?
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Findings of Fact
1. The Specification teaches that “[t]he predetermined data may be
collected prior to the procedure, based on standard parameters known within
the medical field, actual and/or real-time measurements collected from the
patient, or a combination of standard and actual measurements” (Spec. 141).
2. Kesten teaches
A catheter tracking system for visualization of fluoroscopic
images, the system comprising a fluoroscope for generating
fluoroscopic image data, a fluoroscopic image visualization
monitor, a catheter having an elongated shaft, particularly an
intraventricular catheter, distal tip and a radio opaque portion
adjacent the distal tip. A circumferential radio opaque band
may be used to determine the relative position, orientation
and motion of the catheter. An image analysis system capable
of analyzing the image of the catheter and the radio opaque
band, for receiving fluoroscopic image data from the
fluoroscope determining physical parameters related to the
left ventricle, and the relative position, orientation and motion
of the catheter therein, and for determining the location and
other parameters of treatment on intraventricular surfaces.
(Kesten Abstract; see also Ans. 2—3.)
3. Kesten teaches that
it is known that the size and shape of the ventricle changes
with the cardiac cycle. Adding an input to the image
computer which correlates to the cardiac cycle such as the
ECG signal would allow the image computer to capture, store
and register several images of the ventricle shape all
corresponding to different, but known periods during the
cardiac cycle. This also allows a monitor to be updated with
the generated image one time per cardiac cycle, which allows
the user to see changes (such as motion of the catheter) which
do not have the additional motion of the cardiac cycle
superimposed.
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It is also known that during the respiratory cycle the
heart moves relative to a fixed reference outside of the body
such as the fluoroscope. The motion due to respiration can be
tracked by monitoring the respiratory cycle.
(Kesten 15:60-16:8; see also Ans. 6.)
4. Kaiser teaches
A method and system for use in selecting a cardiac pacing site
includes sensors for tracking wall motion (e.g., sensors
coupled to the right and left ventricular heart wall). The wall
motion of one or more non-paced cardiac cycles is compared
to the wall motion of one or more paced cardiac cycles to
determine the effectiveness of one or more pacing sites. For
example, image data may be generated to notify the user as to
the effectiveness of the one or more pacing sites.
(Kaiser Abstract; see also Ans. 3 4.)
5. Kaiser teaches a “system . . . which generally includes an
imaging device . . ., an electromagnetic navigation or tracking system . . .”
(Kaiser 115; see also Ans. 3^4).
6. Kaiser teaches that
while a fluoroscopic C-arm imaging device ... is shown . . .,
any other alternative imaging modality may also be used. For
example, isocentric fluoroscopy, bi-plane fluoroscopy,
ultrasound, computed tomography (CT), multi-slice
computed tomography (MSCT), magnetic resonance imaging
(MRI), high frequency ultrasound (HIFU), optical coherence
tomography (OCT), intra-vascular ultrasound (IVUS), 2D,
3D or 4D ultrasound, or intraoperative CT or MRI may also
be used to acquire pre-operative or real-time images or image
data of the patient . . . [ijmage datasets from hybrid
modalities, such as positron emission tomography (PET)
combined with CT, or single photon emission computer
tomography (SPECT) combined with CT, could also provide
functional image data superimposed onto anatomical data to
be used to confidently reach target sights within the heart or
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other areas of interest. Further, for example, it is further noted
by acquiring images in more than one plane, an icon
representing the location of a catheter or other instrument,
introduced and advanced in the patient . . ., may be
superimposed in more than one view on display . . . allowing
simulated bi-plane or even multi-plane views, including two
and three-dimensional views
(Kaiser | 17; see also Ans. 3—4.)
Principles of Law
The Supreme Court explains that “the [obviousness] analysis need not
seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” KSR Int 7 v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
Id. at 416. “If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability.” Id. at 417.
Analysis
Claims 1—5, 7—10, and 13—20:
Appellant argues the patentability of these claims as a group. We thus
select claim 1 as representative.
We adopt the Examiner’s findings of fact and reasoning with respect
to the rejection of claim 1, and agree with the Examiner that claim 1 would
have been obvious over Kesten and Kaiser. We address below Appellant’s
arguments.
We recognize, but are not persuaded, by Appellant’s contention that to
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modify the positioning system (i.e., image processing
software) and the position sensor (i.e., radiopaque markers)
of Kesten as contended by the Examiner, with the
electromagnetic sensors of Kaiser, would change Kesten’s
principle of operation from an image-based position and
orientation determining process using a specially-constructed
catheter to an electromagnetic field-based position
determining process, as well as rendering the modified
catheter of Kesten unsatisfactory for its intended purpose.
(App. Br. 7—8.) Appellant also contends that “one of ordinary skill in the art
would not have found it obvious to supplement Kesten with Kaiser, as
stated by the Examiner,” and that
merely providing “additional means for tracking the distal
end” is simply a statement of the result of the combination
and does not constitute a reason for making the combination
in the first place. The Examiner’s reliance on the result of the
combination as a reason for the combination constitutes
improper logic.
(Id. at 8; see also Reply Br. 2—3.) More particularly, Appellant argues that
“contributing an additional (i.e., duplicative) positioning system of Kaiser
into Kesten will not result in a combination that is any of stronger, cheaper,
cleaner, faster, lighter, smaller, more durable or more efficient than Kesten
alone” (App. Br. 9; see also Reply Br. 4—6).
As the Examiner explains,
the radiopaque markers along the length of the catheter are
passive localizing devices that provide positional data by
reflecting the fluoroscopic energy emitted by Kesten’s
fluoroscopic device, but do not sense anything (e.g. data from
an outside source) and therefore are different from the
positional sensor at the distal end of the device (as taught by
Kaiser). Kaiser teaches an active localizing sensor that
transmits positional data to and receives positional data from
the localizing system, data about the position of the distal end
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of the device (as described in paragraphs [009 — 0032]).
Additionally, Kaiser’s magnetic-based medical position
system works in conjunction with fluoroscopic imaging
technology (imaging device, as described in paragraph [0017]
of Kaiser). Kaiser teaches also providing wall motion data
from the position indicating signals ([0032]: “electromagnetic
sensor coil 258R, 258L). ... As both Kesten and Kaiser are
medical positioning systems and the Kaiser reference is open
to MRI and fluoroscopy (as explained in the cited paragraphs
of Kaiser), it would be reasonable to one of ordinary skill in
the art to combine the two references such that the Kesten
reference has an additional sensing means of the device
position (as taught by Kaiser) in addition to fluoroscopy-
radiopaque-marker (imaging) tracking means of the device
position (as taught by Kesten). It would also be [a] reasonable
motivation to one of ordinary skill in the art to combine these
positional sensing technologies of Kesten and Kaiser as the
combination would provide improved accuracy and precision
of tracking of the entire length of the catheter device, which
would help provide better results of treatment to the patient.
This is not merely a statement of result of the combination,
but also a valid reason for providing such a combination of
technologies.
(Ans. 13—14; FF 2—7.) See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir.
1997) (“[Attorney argument [is] not the kind of factual evidence that is
required to rebut a prima facie case of obviousness”).
We recognize, but are not persuaded, by Appellant’s contention that
such a combination would appear to be more costly (due to
duplicate structure), heavier (duplicate structure), more
complex (due to duplicate structures) and possibly less
durable as a result, and potentially less efficient by virtue of
having to coordinate duplicate positioning systems.
Appellant, based on the current record, does not discern why
one of ordinary skill would be incented or motivated to the
make the combination of Kesten and Kaiser, and for at least
this reason, further submit that the rejection is improper.
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(App. Br. 9.)
As the Examiner explains,
[duplication of parts or structures does not necessarily lead
to higher cost, heavier devices, and/or less durable devices
because there are also other factors involved in making
devices such as making devices that are more complex so that
they are capable of accomplishing more tasks or needs.
Furthermore, while trying to make devices more complex,
artisans of ordinary skill will also look for ways to lower costs
by finding cheaper material that is also more efficient,
durable, lighter, biocompatible, etc.
(Ans. 9.) See In re Geisler, 116 F.3d at 1470. See also Medichem, S.A. v.
Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“[OJbviousness must be
determined in light of all the facts, and there is no rule that a single reference
that teaches away will mandate a finding of nonobviousness. Fikewise, a
given course of action often has simultaneous advantages and disadvantages,
and this does not necessarily obviate motivation to combine.”) A
combination of references may be obvious even if the combination
eliminates a benefit of one of the references. See In re Urbanski, 809 F.3d
1237, 1242 (Fed. Cir. 2016).
Consequently, Appellant has provided no persuasive factual evidence
to show that Kesten’s device, as modified by Examiner, would have been
either more expensive, more difficult or in any way inoperable in relation to
tracking a tool relative to a wall of a region of interest of a patient.
Appellant contends that
paragraph [0017] of Kaiser is directed to different imaging
embodiments, not its tracking functionality. Thus, such
purported advantage is inapplicable to the proposed
modification since the Examiner cites Kaiser for its teaching
of a reference positioning sensor and not its teaching of
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imaging capabilities. Moreover, the statement “confidently
reach target sites” is at most laudatory in nature, and the
unmodified disclosure of Kesten can already be said to make
similar disclosures (e.g., col. 3,11. 36-41: “. . . to allow faster
and more accurate placement of channels.”).
(App. Br. 9 see also Reply Br. 6.)
This argument is unpersuasive. Concerning paragraph [0017] of
Kaiser, as the Examiner explains,
this is in reference to one of the many teachings of Kaiser that
presents device tracking means in conjunction with
compatible medical imaging technology, including the one
taught by Kesten (i.e. fluoroscopy imaging). As indicated
above, Kaiser also teaches device position tracking via
position sensor located at distal end of the device (for
example, see paragraphs [0029 — 0032] of Kaiser).
(Ans. 15 (emphasis added).) In other words, the use of a magnetic field for
tracking does not foreclose its use in imaging because one capability is not
exclusive with respect to the other capability.
We recognize, but are not persuaded, by Appellant’s contention that
the Examiner has not explained how [the] combination [of
Kaiser and Kester] would work, in light of the radio opaque
marker bands interposed between a source of electromagnetic
radiation and the positioning sensor. While the Examiner
mentions that Kaiser teaches “that it is possible to use
fluoroscopic imaging system with an electromagnetic
tracking system” (p. 14), Kaiser does not address the
situation presented above involving interposed radio opaque
marker bands.
(App. Br. 11.) More particularly, Appellant argues that “the electromagnetic
positioning sensor of Kaiser—now at the distal end of the tool of Kesten—
would be enclosed by the above-mentioned plurality of radio opaque marker
bands” (id.; see also Reply Br. 8—9). Appellant also argues that
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metal can interfere with the operation of an electromagnetic
field sensor, as seen by reference to at least U.S. Pat. No.
6,233,476 (“metal object interference”). In this light,
Appellant submits that one of ordinary skill in the art would
understand the potential problems referred to by Appellant
attendant the combination proposed by the Examiner.
(Id.)
We are not persuaded. The combination of Kaiser and Kesten does
not require that the electromagnetic sensor be enclosed by the radio opaque
marker bands. In other words, the claims do not exclude the positioning of
an electromagnetic sensor next to or near a radio opaque marker, as opposed
to one of them being enclosed relative to the other. “[Limitations are not to
be read into the claims from the specification.” In re Van Geuns, 988 F.2d
1181, 1184 (Fed. Cir. 1993). See also In re Self, 671 F.2d 1344, 1348
(CCPA 1982) (“[Ajppellanf s arguments fail from the outset because ... they
are not based on limitations appearing in the claims.”).
Moreover, Appellant does not provide any evidentiary basis to support
the contention that metal interference would render the combination Kaiser
and Kesten inoperable. See In re Geisler, 116 F.3d at 1470. Kaiser
evidences that fluoroscopic imaging may be used with other modalities such
as magnetic resonance imaging (FF 6; see also Ans. 15—16). We therefore
agree with the Examiner that it would have been obvious include a position
sensor using a magnetic field as taught by Kaiser with the medical
positioning system of Kesten (see Ans. 4, 16). The combined teachings of
Kesten and Kaiser regarding magnetic field sensing, would yield predictable
results of more accurate tracking of medical devices (see Ans. 14).
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We therefore affirm the rejection of independent claims 1, 14, and 18.
Because Appellant does not argue the claims separately, claims 2—5, 7—10,
13, 15—17, 19, and 20 fall with these claims.
Claim 6:
Claim 6 recites “wherein creating the wall motion profile is further
performed based on one of (i) predetermined motion pattern data for the
region of interest and (ii) a combination of the predetermined motion pattern
data and the measured region of interest motion data” (see Appellant’s claim
6).
Appellant contends that “the ECG signal in Kesten does not constitute
predetermined motion pattern data’ because the ECG signal is not
predetermined but is rather disclosed as a real time signal” (App. Br. 13 see
also Reply Br. 10-11).
This argument is unpersuasive.
The Specification teaches that “[t]he predetermined data may be
collected prior to the procedure, based on standard parameters known within
the medical field, actual and/or real-time measurements collected from the
patient, or a combination of standard and actual measurements” (FF 1).
Kesten teaches that “[ajdding an input to the image computer which
correlates to the cardiac cycle such as the ECG signal would allow the image
computer to capture, store and register several images of the ventricle shape
all corresponding to different, but known periods during the cardiac cycle,”
and that “[i]t is also known that during the respiratory cycle the heart moves
relative to a fixed reference outside of the body such as the fluoroscope. The
motion due to respiration can be tracked by monitoring the respiratory
cycle” (FF 3).
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We thus agree with the Examiner that
interpretation of predetermined motion dat[a] in Kesten
includes to [sic] what is considered a normal cardiac cycle or
respiratory cycle, and cited passages Keston’s teachings of
using “amplitude-correlation function” is used for
determining actual cycle or actual position when it deviates
from a threshold or normal cardiac motion data ) i.e.
corresponding predetermined data or level).
(Ans. 17.)
Claims 11 and 12:
Claim 11 recites “wherein the at least one component is the
frequency-based component, and wherein said comparing includes:
determining whether a predetermined frequency component present in the
wall motion is present in the tool motion” (see Appellant’s claim 11). Claim
12 depends from claim 11.
The Examiner asserts that the rejection of claims 11 and 12 were
based on “passages of Kesten that rely on frequency-based components of
ECG that record cardiac cycle of the heart (which implicitly includes heart
wall motion data). . . col. 16 line 60-col. 17, line 12)” (Ans. 16).
The Examiner’s explanation is unpersuasive. Instead, we agree with
Appellant that “Kesten discloses that its wall contact detection ‘is
implemented by creating a correlation function between an amplitude of the
catheter movement with the ECG signal’ (emphasis added; col. 16, lines 60—
62)” (App. Br. 12; see also Reply Br. 10—11). Accordingly, the Examiner
has not met the burden to show that claim 11 would have been obvious.
We thus reverse the rejection of claim 11. Because of its dependency
from claim 11, we reverse the rejection of claim 12 as well.
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SUMMARY
In summary, we affirm the rejection of claims 1, 14, and 18 under 35
U.S.C. § 103(a) as obvious over Kesten and Kaiser. Claims 2—5, 7—10 and
13 fall with claim 1, claims 15—17 fall with claim 14, and claims 19 and 20
fall with claim 18. We also separately affirm claim 6.
We reverse the rejection of claims 11 and 12 under 35 U.S.C. § 103(a)
as obvious over Kesten and Kaiser.
AFFIRMED-IN-PART
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