Ex Parte Ludwin et al

Patent Trial and Appeal Board

Feb 25, 2019

13680496 (P.T.A.B. Feb. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/680,496 11/19/2012
27777 7590 02/27/2019
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
FIRST NAMED INVENTOR
Doron Moshe Ludwin
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
BI05355USNP 6252
EXAMINER
HOEKSTRA, JEFFREY GERBEN
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
02/27/2019 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):
jnjuspatent@corus.jnj.com
lhowd@its.jnj.com
pairjnj@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DORON MOSHE LUDWIN, ASSAF GOV ARI, AHARON
TURGEMAN, YOHAI MAKBIL Y, and ELIAHU ZINO
Appeal2017-009561
Application 13/680,496 1
Technology Center 3700
Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and DAVID
COTTA, Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 relates generally to invasive
probes, and specifically to estimating tissue thickness based on location and
contact force measurements received from an invasive probe. Spec. ,r 1.
The Examiner rejected the claims on appeal under 35 U.S.C. 103(a) as
obvious.
We affirm.
1 According to Appellants, the real party in interest is Bio sense Webster
(Israel) Ltd. App. Br. 1.
Appeal2017-009561
Application 13/680,496
STATEMENT OF THE CASE
Claims 1, 2, and 14--22 are on appeal. Claims 1 is illustrative and
reads as follows:
1. A method, comprising:
initializing a plurality of calibration matrices in a
processor, each of the calibration matrices associated with a
type of tissue;
locating a distal end of a medical probe against a wall of
a body cavity, the distal end including a position sensor;
determining a precise location of the distal end of the
probe, including both location and orientation coordinates, by
receiving first position measurements in the processor from the
position sensor indicting a first location of the probe upon the
probe engaging the wall, the first position measurements
indicative of location coordinates of the distal end relative to a
working volume that contains the body cavity;
identifying the type of tissue of the wall of the body
cavity based on the location of the distal tip of the probe
relative to the body cavity;
pressing the distal end of the medical probe against the
wall of the body cavity;
receiving in the processor, from the probe, first
measurements of a force exerted by the distal end on the wall;
receiving from the position sensor second measurements
indicating a displacement of the wall in response to the force;
and
estimating a thickness value of the wall based on the first
and the second measurements, the type of tissue, and the
plurality of calibration matrices.
App. Br. 12.
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Application 13/680,496
The claims stand rejected as follows.
I. Claims 1, 2, 4--6, 10-12, 14--16, and 20-22 were rejected
under 35 U.S.C. § I03(a) as obvious over the combination of Hauck2
and Harry. 3
II. Claims 7 and 17 were rejected under 35 U.S.C. § I03(a)
as obvious over the combination of Hauck, Harry, and Wang. 4
III. Claims 8, 9, 18, and 19 were rejected under 35 U.S.C.
§ I03(a) as obvious over the combination of Hauck, Harry, and Lasso. 5
IV. Claims 1, 2, 4--6, 8-12, 14--16, and 18-22 were rejected
under 35 U.S.C. § I03(a) as obvious over the combination of Hauck,
Harry, and Lasso.
V. Claims 7 and 17 were rejected under 35 U.S.C. § I03(a)
as obvious over the combination of Hauck, Harry, Lasso, and Wang.
FINDINGS OF FACT
1. The Specification discloses:
In an estimation step 106, processor 40 identifies an element
in the calibration matrix that has force and displacement
values corresponding to the collected force and the
displacement measurements, and retrieves a thickness value
from the identified calibration matrix element, and the
method ends. In instances where corresponding values for
the collected force and displacement measurements are not
explicitly found in the calibration matrix, processor 40 can
2 Hauck, US Patent Publication No. 2009/0062642 Al, published Mar. 5,
2009 ("Hauck").
3 Harry et al., US Patent Publication No. 2011/0319791 Al, published Dec.
29, 2011 ("Harry").
4 Wang et al., US Patent Publication No. 2012/0095305 Al, published Apr.
19, 2012 ("Wang").
5 Lasso et al., US Patent Publication No. 2010/0130878 Al, published May
27, 2010 ("Lasso").
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Appeal2017-009561
Application 13/680,496
estimate the thickness by calculating a thickness based on an
interpolation between two force and/or displacement values
found in the calibration matrix.
Spec. ,r 50.
2. Harry discloses that "[i]mparting a deforming pressure to a
tissue surface while recording the resulting changes in topography with 3D
SPI, these in-vivo measurements include, but are not limited to, ...
assessing aneurysm rupture risk by measuring the wall thickness or stiffness
of the aneurismal sac." Harry if 44.
3. Hauck discloses a system and method for "probing internal
patient tissue in order to obtain force and/or tissue displacement
measurements." Hauck Abstract. "These measurements are utilized to
generate an indication of tissue elasticity." Id.
4. Hauck discloses an "electrode catheter 14 . .. [that] includes a
tip electrode 20 and a force transducer 22." Hauck ,r 37. The force
transducer "generate[ s] an output that is indicative of a force applied to the
tip electrode 20." Id.
5. Hauck discloses:
In one exemplary embodiment, the force transducer is a three-
axis transducer that is operative to generate vector information.
In this regard, if the tip electrode 20 is contacted with a tissue
wall, the force applied to the tip electrode 20 as well as the
angle the tip electrode 20 contacts the wall may be determined.
Id. ,I 38.
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Application 13/680,496
6. Hauck discloses a system that determines the location of an
electrode probe before and after it contacts the tissue being probed. This is
shown in Figures 4A-4C (reproduced below).
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FIG.4A FlG.48 FIGAC
"FIGS. 4A, 4B and 4C illustrate advancement of a catheter relative to
internal patient tissue." Hauck ,r 27. Hauck discloses that "a position of
initial contact" between the electrode (20) and the tissue (24) may be
identified, as shown in Figure 4A, and "utilized as a reference position." Id.
,r 47. As shown in Figure 4B, after first contact between Hauck's catheter
and a tissue, the electrode "may be displaced a first distance x1 ( e.g., relative
to the reference position) to a first position." Id. ,r 48. The "tissue
displacement x1 may be recorded." Id. As shown in Figure 4C, "electrode
20 may be advanced to a second distance x2 to a second position." Id; see
also id. ,r 14. The "tissue displacement x2 may also be recorded." Id. ,r 48.
7. Hauck discloses that "[ t ]he process of obtaining force and
displacement measurements may be repeated at a plurality of different
locations for a tissue area of interest." Id. ,r 49. "As a user probes the
septum, an indication may be generated on the image indicating the tissue
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Appeal2017-009561
Application 13/680,496
location that has been probed." Id. ,r 53. This is shown in Figure 5A
(reproduced below).
·11
70e 7Gb /
I /}~-/:-------ii\ I
I / r/ K;--.h J K-;--.2u • \ I
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l. l \, 1 I ' "' "' K1•.il • • ) I
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"As shown in FIG. SA a plurality of tissue locations 70a-n within the tissue
area may be probed an indication of each probed location may be correlated
with the image." Id.
8. Hauck also discloses that infonnation provided by the electrode
20 can be for inten1al mapping and modeling. Id. ir 39 ("The tip electrode
20 and/or electrodes of another catheter 14a may be implemented to
electrically map the myocardium (i.e., muscular tissue in the heart wall");
see also id. ,i- 40. For Example, Hauck's catheter system may "track catheter
movement and construct three-dirnensional (3-D) models of the heart
chamber in which the catheter is positioned." id. ~f 40. T'he models may be
generated in ''substantially real-time" and "utilized to, for example, guide
the catheter 14 to one or more locations in the heart where treatment is
needed." Id.
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Application 13/680,496
9. Hauck discloses that "tissue elasticities may be correlated with
an image in order to provide a visual indication of different elasticity values
for different tissue locations. Accordingly, a user may utilize this image to
identify, for example, the fossa ovalis for performing a transseptal
procedure." Id. ,r 54.
10. Hauck discloses:
Further, stored data indicative of predetermined elasticity
values may be utilized to generate an elasticity value for a force
and/or displacement measurement. That is, a force
measurement, a displacement measurement, or both may be
utilized with, for example, predetermined look-up tables,
equations, or other data ( e.g., collectively catalog data) to
determine an elasticity value for a tissue location.
Id. ,I 52.
11. Lasso discloses:
Vessel wall thickness can be determined in one of the following
ways: (i) a direct measurement via three-dimensional
characterization or intravascular ultrasound may be performed
and employed; and/or (ii) indirect measurement can be done by
measuring actual deformation of the vasculature due to blood
pressure change within the cardiac cycle.
Lasso ,r,r 56.
12. Lasso discloses:
A third approach is to estimate wall thickness by retrieval of
similar data from the database 126 of FIG. 1. When direct
measurement is not available, then a database is used to
estimate the wall thickness. The database 126 is built from
measurements of dissected vasculature tissues (e.g., healthy
vessel of different sizes at different places, aneurysm wall
thickness of different parts of the aneurysm). The thickness is
determined by selecting the data that is most alike the current
vasculature
Id. ,I 57.
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Appeal2017-009561
Application 13/680,496
OBVIOUSNESS OVER HAUCK AND HARRY (GROUND I).
Appellants argue claims 1, 2, 4--6, 10-12, 14--16, and 20-22 together.
We designate claim 1 as representative.
In rejecting claim 1 as obvious, the Examiner found that Hauck
disclosed most of the elements of claim 1. Final Act. 6 3-6. With respect to
the requirement of claim 1 for "estimating a thickness value of the wall," the
Examiner found that Hauck disclosed calculating tissue elasticity which
"corresponds [to] and provides an estimate of tissue thickness relative to
other portions to identify an area of tissue thinness for a procedure." Id. at 5.
The Examiner also found that Harry disclosed, inter alia, "assessing
aneurysm rupture risk by measuring the wall thickness or stiffness of the
aneurismal sac." Id. at 6. The Examiner concluded that it would have been
obvious to "modify the method taught/disclosed by Hauck which includes
calculating and displaying the parameter of interest based upon the force and
displacement measurements to include the measuring wall thickness value
based on force and displacement measurements as taught by Harry in order
to assess the strength of cavity wall and identify possible areas for rupture."
Id.
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art and agree that the claims are obvious over
Hauck and Harry. We address Appellant's arguments below.
Appellants argue that neither Hauck nor Harry discloses estimating a
thickness value of a wall of a body cavity, as required by claim 1. App. Br.
5-7. Appellants contend that Hauck only discloses "compar[ing] tissue wall
thickness based on elasticity," while the claims require "an actual value, i.e.
6 Office Action mailed August 26, 2016 ("Final Act.").
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Application 13/680,496
the actual thickness of the tissue, and not a relative or comparative thickness
to other tissue." Id. 5, 6. Appellants contend that Harry discloses only
determining mechanical properties which includes "stiffness, hardness,
viscoelasticity, and directional anisotropy," but which does not include
tissue thickness. Id. at 6. Appellants acknowledge that Harry discloses that
"in-vivo measurements can assess aneurysm rupture risk by measuring the
wall thickness," but contends that Harry does not provide a supporting
description of such measurement. According to Appellants, "Harry can only
determine the tissue anomaly, i.e. the thinning of the tissue wall at the
aneurysm, to locate the aneurysm. There is simply no teaching that the
actual wall thickness of the tissue can be calculated." Id. at 6-7. We are not
persuaded.
As an initial matter, we agree with the Examiner that the phrase
"estimating a thickness value of the wall" encompasses relative values. Ans.
4. As the Examiner explains, "[t]he definition of the term 'value' includes:
'relative worth, utility, or importance' and 'a numerical quantity that is
assigned or is determined by calculation or measurement."' Id. at 5.
Appellants contend that the portion of the Specification that describes
the estimation of tissue thickness (Spec. ,r 37 et. seq.) makes "clear that it is
the actual thickness of the tissue that is being determined, i.e. a tissue
thickness value" which is "in line with the dictionary definition provided by
the Examiner, i.e. a numerical quantity." Reply Br. 3. We have reviewed
the portion of the Specification referenced by Appellants, which describes an
embodiment in which a processor "retrieves a thickness value form the
identified calibration matrix element" or, alternatively, "[i]n instances where
corresponding values for the collected force and displacement measurements
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Application 13/680,496
are not explicitly found in the calibration matrix, processor 40 can estimate
the thickness by calculating a thickness based on an interpolation between
two force and/or displacement values found in the calibration matrix." FFl.
While this disclosure is consistent with determining the actual thickness of a
wall, it is not clear that it excludes relative values. Moreover, "a court may
not read into a claim a limitation from a preferred embodiment, if that
lirnitation is not present in the claim itself." Bayer AG v. Biovail Corp., 279
F.3d 1340, 1348 (Fed. Cir. 2002). Here, the claim itself does not exclude
relative values. For this reason, we are not persuaded by Appellants
argument that the cited art does not disclose estimating a thickness value of a
wall of a body cavity.
In addition, Harry expressly discloses measuring the thickness of a
wall. FF2 ("By imparting a deforming pressure to a tissue surface while
recording the resulting changes in topography with 3D SPI, these in-vivo
measurements include, but are not limited to, ... assessing aneurysm rupture
risk by measuring the wall thickness or stiffness of the aneurismal sac.").
Appellants acknowledge this teaching but argue that Harry provides "no
description of how wall thickness is calculated." App. Br. 6. Appellants
contend that "Harry can only determine the tissue anomaly, i.e. the thinning
of the tissue wall at the aneurysm, to locate the aneurysm. There is simply
no teaching that the actual wall thickness of the tissue can be calculated."
Id. at 6-7. We are not persuaded because, as the Examiner explains, Harry
"teaches that force and displacement measurements can be used to
measure[ e] various different tissue properties ... including measuring tissue
wall thickness." Ans. 5.
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Moreover, prior art cited by an examiner is presumed to be enabling.
In re Sasse, 629 F.2d 675, 681(CCPA 1980); see also In re Antor Media
Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012). Once such a reference is
found, the burden is on the Appellants to provide evidence rebutting the
presumption. Id. Here, Appellants have not directed us to sufficient
evidence in the record to rebut the presumption that Harry's disclosure is
enabling. In re Sasse, 629 F .2d at 681. Appellants' arguments are
additionally unpersuasive because they rely exclusively on attorney
argument, which cannot take the place of evidence. In re Geisler, 116 F .3d
1465, 1470 (Fed. Cir. 1997); In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir.
1984).
Appellants argue that neither Hauck nor Harry teaches or suggests "to
use a position sensor, a coordinate system and a working volume to
determine the location of the probe and the body cavity, particularly to
determine the type of tissue being analyzed." App. Br. 7. Appellants further
argue that the only disclosure in the art is of a "contact/no contact position
by measuring tissue impedance at the position of initial contact." Id. We
are not persuaded.
We agree with the Examiner that Hauck discloses an electrode probe
system in which the position of the probe is used to determine the elasticity
of the tissue and assist in mapping. Ans. 7-9; FF3-FF8. The system may
generate a 3D coordinate system that tracks the location and position of the
probe in real time. FF8. The elasticity values and the image generated may
be used to identify the type of tissue being analyzed. See, e.g, FF9.
In response to the Examiner's answer, Appellants argue that the
system disclosed in Hauck "does not determine a precise location of the
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Application 13/680,496
distal end of the probe (before and after displacement) using a position
sensor, both location and orientation coordinates, a coordinate system and a
working volume." Reply Br. 5. Instead, according to Appellants, Hauck's
system "only constructs a 3 dimensional model of the heart chamber in []
which the catheter is positioned." Id. Appellants assert that Hauck's model
is "used to guide the catheter to one or more locations in the heart where
treatment is needed" and thus "[t]here is ... no disclosure that the NavX
system determines the precise location of the distal end of the probe." Id.
We are not persuaded.
Hauck uses an electrode probe to generate an elasticity value. FF3---6.
Hauck does this, in part, by contacting tissue with a probe and determining a
tissue displacement distance (FF3, FF6), which requires determining the
precise location of the distal end of the probe. In addition, Hauck identifies
each location were the probe contacts tissue and displays it, which also
requires determining the precise location of the distal end of the probe. FF7.
Further, Hauck displays location of the probe in a three-dimensional model
to guide the probe in real time so that the user can guide the probe to a
desired location. FF8. Again this requires determining the precise location
of the distal end of the probe. For these reasons, we do not agree with
Appellants that Hauck fails to disclose this element.
Accordingly, we affirm the Examiner's rejection of claim 1 as
obvious over the combination of Hauck and Harry. Because they were not
argued separately, claims 1, 2, 4---6, 10-12, 14--16, and 20-22 fall with claim
1.
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Application 13/680,496
OBVIOUSNESS OVER HAUCK, HARRY, AND WANG (GROUND II).
Appellants argue claims 7 and 17 together. We designate claim 1 7 as
representative.
Claim 1 7 requires that "the processor is configured to estimate the
thickness of the wall by interpolating between the thickness values stored in
two calibration matrix elements." Appellants argue that the Examiner erred
in rejecting claim 17 for the reasons discussed in connection with Ground I.
App. Br. 8. We are not persuaded for the reasons already discussed. In
addition, Appellants argue that "[t]he references do not teach looking up
thickness as indicated by the Examiner. Instead, the references only teach
looking up elasticity as a tissue property based on the force and tissue
displacement measurements." Id. We are not persuaded.
Harry discloses measuring tissue thickness based on force and
displacement measurements. FF2. Hauck discloses using force and
displacement measurements with predetermined lookup tables to determine
an elasticity value. FFlO. We agree with the Examiner that it would have
been obvious to "modify the device/method taught by Hauck including the
use of suitable means such as look-up tables, equations etc. to include
measuring thickness of tissue using force and displacement measurements as
taught by Harry, to estimate a tissue thickness value." Ans. 10. In addition,
we note, as did the Examiner, that "Wang ... teaches the concept of
interpolating between values in a table to estimate values between table
values." Id. at 11; see Wang ,r 64. This further supports the obviousness of
the interpolating between stored values.
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Application 13/680,496
Accordingly, we affirm the Examiner's rejection of claim 17 as
obvious over Hauck, Harry, and Wang. Because it was not argued
separately, claim 7 falls with claim 1 7.
OBVIOUSNESS OVER HAUCK, HARRY, AND LASSO (GROUND III)
Appellants argue that claims 8, 9, 18, and 19 are non-obvious because
the combination of Hauck and Harry do not include all of the limitations of
claims 1 and 11, from which claims 8, 9, 18, and 19 depend. App. Br. 9.
Appellants argue that "[ n ]othing in Lasso overcomes this deficiency and the
Examiner has made no such assertion." Id. We are not persuaded because,
for the reasons discussed above, Appellants have not persuaded us that the
Examiner erred in rejecting claims 1 and 11 as obvious over the combination
of Hauck and Harry. Accordingly, we affirm the Examiner's rejection of
claim 8, 9, 18, and 19 for the reasons discussed above in connection with
Ground I.
OBVIOUSNESS OVER HAUCK, HARRY, AND LASSO (GROUND IV)
Appellants argue claims 1, 2, 4---6, 8-12, 14--16, and 18-22 together.
We designate claim 1 as representative.
The Examiner alternatively rejected claims 1, 2, 4--6, 8-12, 14--16,
and 18-22 as obvious over the combination of Hauck, Harry, and Lasso. In
doing so, the Examiner applied Hauck and Harry as discussed in connection
with Ground 1. In addition, the Examiner found that Lasso disclosed a
system that measures tissue deformation and, "in response to a change in
applied force/pressure[,] the computer system ... calculates a tissue
thickness value based upon the measurements by comparing the results to
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Application 13/680,496
known sample information, the system then uses the calculated values to
generate a model of the tissue including the wall thickness." Final Act. 23-
24. Based on this disclosure, the Examiner concluded that it would have
been obvious to "to modify the system taught by Hauck to include
estimating wall thickness by using a plurality of database sets as taught by
Lasso in order to provide a closest fit or more accurate representation of the
current tissue state by using clinical information which most closely matches
the current tissue." Id.
As discussed above, we agree with the Examiner that the combination
of Hauck and Harry renders claim 1 obvious. We also agree with the
Examiner that Lasso provides additional evidence that it would have been
obvious to estimate a wall thickness by using a plurality of databases. See
FFll, FF12.
Appellants argue that Lasso does not teach "to use a coordinate
system and a working volume to determine the location of the probe and the
body cavity particularly to determine the type of tissue being analyzed in
real-time." App. Br. 10. We are not persuaded because, as discussed above,
this limitation is disclosed by the combination of Hauck and Harry. In re
Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) ("Non-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references.").
Accordingly, we affirm the Examiner's rejection of claim 1 as
obvious over the combination of Hauck, Harry and Lasso. Because they
were not argued separately, claims 2, 4--6, 8-12, 14--16, and 18-22 fall with
claim 1.
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OBVIOUSNESS OVER HAUCK, HARRY, LASSO, AND WANG
(GROUNDV)
Appellants argue claims 7 and 17 together. We designate claim 17 as
representative.
Claim 1 7 requires that "the processor is configured to estimate the
thickness of the wall by interpolating between the thickness values stored in
two calibration matrix elements." Appellants argue that the Examiner erred
in rejecting claim 17 for the reasons discussed in connection with Ground
IV. We are not persuaded for the reasons already discussed. In addition,
Appellants argue that "the references do not teach looking up thickness as
indicated by the Examiner. Instead, the references only teach looking up
elasticity as a tissue property based on the force and tissue displacement
measurements." App. Br. 11. We addressed this argument in connection
with Ground II and are not persuaded for the reasons already discussed.
Accordingly, we affirm the Examiner's rejection of claim 17 as obvious over
the combination of Hauck, Harry, Lasso, and Wang. Because it was not
argued separately, claim 7 falls with claim 1 7.
SUMMARY
For the reasons set forth herein and the reasons set forth in the
Examiner's Answer and Final Office Action, we affirm all five of the
Examiner's rejections. In summary:
We affirm the Examiner's rejection of claims 1, 2, 4--6, 10-12, 14--16,
and 20-22 under 35 U.S.C. § 103(a) as obvious over the combination of
Hauck and Harry.
We affirm the Examiner's rejection of claims 7 and 17 under
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35 U.S.C. § 103(a) as obvious over the combination of Hauck, Harry, and
Wang.
We affirm the Examiner's rejection of claims 8, 9, 18, and 19 were
rejected under 35 U.S.C. § 103(a) as obvious over the combination of
Hauck, Harry, and Lasso.
We affirm the Examiner's rejection of claims 1, 2, 4---6, 8-12, 14--16,
and 18-22 under 35 U.S.C. § 103(a) as obvious over the combination of
Hauck, Harry, and Lasso.
We affirm the Examiner's rejection of claims 7 and 17 under
35 U.S.C. § 103(a) as obvious over the combination of Hauck, Harry, Lasso,
and Wang.
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).
AFFIRMED
17