Ex Parte Pelissier et al

Patent Trial and Appeal Board

Mar 6, 2018

13570136 (P.T.A.B. Mar. 6, 2018)

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.
13/570,136 08/08/2012 Laurent Pelissier ULT-10-7516(ANA1189-US) 8427
23266 7590 03/08/2018
DRIGGS, HOGG, DAUGHERTY & DEL ZOPPO CO., L.P.A.
38500 CHARDON ROAD
DEPT. DLBH
WILLOUGBY HILLS, OH 44094
EXAMINER
KINNARD, LISA M
ART UNIT PAPER NUMBER
3786
NOTIFICATION DATE DELIVERY MODE
03/08/2018 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):
usptocommunications@driggslaw.com
carole@driggslaw.com
mwheeler @ driggslaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LAURENT PELISSIER and JOSEPH BJORKLUND.1
Appeal 2017-002242
Application 13/570,136
Technology Center 3700
Before JEFFREY N. FREDMAN, TAWEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for targeting a blood vessel which have been rejected as being
directed to non-statutory subject matter and as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
In some medical procedures, it is important that the blood
vessel in which an object is inserted is one or the other of a vein
and an artery. Veins and arteries may be located close together,
1 Appellants identify the Real Party in Interest as Analogic Corporation.
App. Br. 2.
Appeal 2017-002242
Application 13/570,136
and their shapes may be somewhat similar. As a result, persons
performing medical procedures may have difficulty
distinguishing veins from arteries depicted in ultrasound
images.
Spec. 1. The Specification describes a method and apparatus for locating
arteries and veins in a body. Spec. 2.
Claims 1—56 are on appeal. Claim 1 is illustrative and reads as
follows:
1. A method for targeting a blood vessel, the method
comprising:
acquiring ultrasound data for a plane within a body;
automatically determining a target sample volume at an
intersection of a trajectory of an insertable instrument with the
plane, wherein prior to the determining the target sample
volume, a spatial relationship between the trajectory and the
plane is known and the target sample volume is unknown;
acquiring Doppler ultrasound data at least for the target
sample volume at the intersection; and
communicating an indicator of flow characteristics in the
target sample volume, the indicator based on the Doppler
ultrasound data.
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Application 13/570,136
The claims stand rejected under 35 U.S.C. § 103(a) as follows.
Claims 1—56 have been rejected under 35 U.S.C. § 101 as being
directed to ineligible subject matter.
Claims 1, 23—26, 28, 29, 51—53, and 5 have been rejected under 35
U.S.C. § 103(a) as unpatentable over Lazebnik2 in view of Gattani.3
Claims 2 and 30 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Lazebnik in view of Gattani and in further view of
Rogers.4
Claims 3 and 31 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Lazebnik in view of Gattani and in further view of
Heasty.5
Claims 4, 8—21, 22, 32, and 36-45 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Lazebnik in view of Gattani in further view of
Spratt.6
Claims 5, 6, 33, and 34 have been rejected under 35 U.S.C. § 103(a)
as unpatentable over Lazebnik in view of Gattani in further view of Spratt
and Chen.7
Claims 7 and 35 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Lazebnik in view of Gattani in further view of Spratt and
Crutchfield.8
Claim 20 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Lazebnik in view of Gattani in further view of Spratt and Christopher.9
Claims 27 and 54 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Lazebnik in view of Gattani in further view of Paltieli10
and Carol.11
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Application 13/570,136
THE REJECTION UNDER 35 U.S.C. § 101
Appellants present no arguments directed to the rejection based on 35
U.S.C. § 101. We therefore affirm this rejection. See 37 C.F.R.
§ 41.37(c)(l)(iv) (Appeal Brief must contain “[t]he arguments of appellant
with respect to each ground of rejection.”); Hyatt v. Dudas, 551 F.3d 1307,
1314 (Fed. Cir. 2008) (“When the appellant fails to contest a ground of
rejection to the Board, . . . the Board may treat any argument with respect to
that ground of rejection as waived.”).
THE REJECTIONS UNDER 35 U.S.C. § 103(a)
Lazebnik combined with Gattani
Issue
The issue with respect to all the rejections is whether a preponderance
of the evidence supports the Examiner’s conclusion that the claims would
have been obvious over the combination of Lazebnik and Gattani.
2 Lazebnik, US 2012/0157834 Al, published June 21, 2012 (“Lazebnik”).
3 Gattani et al., US 2008/0097155 Al, published Apr. 24, 2008 (“Gattani”)
4 Rogers et al., US 2005/0033177 Al, published Feb, 10, 2005 (“Rogers”).
5 Heasty et al., US 2011/0015527 Al, published Jan. 20, 2011 (“Heasty).
6 Spratt et al. US 6,023,968, issued Feb. 15, 2000 (“Spratt”).
7 Chen et al., The Power Doppler Velocity Index, Pulsatility Index, and
Resistive Index Can Assist in Making a Differential Diagnosis of Ovarian
Carcinoma and Krukenberg Tumors, 26 J. Ultrasound Med. 921 (2007)
(“Chen”).
8 Crutchfield et al., US 2004/0152984 Al, published Aug. 5, 2004,
(“Crutchfield”).
9 Christopher et al., US 2003/0045797 Al, published Mar. 6, 2003
(“Christopher”).
10 Paltieli, US 6,216,029 Bl, issued Apr. 10, 2001 (“Paltieli”).
11 Carol, US 4,955,891, issued Sept. 11, 1990 (“Carol”).
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Application 13/570,136
The Examiner contends that Lazebnik discloses a method for targeting
a blood vessel comprising acquiring ultrasound data for a plane within a
body; acquiring Doppler ultrasound data for a target sample volume at the
intersection and communicating an indicator of flow characteristics for the
target sample volume where the indicator is based in the Doppler ultrasound
data. Final Act. 4—5. The Examiner finds that Gattani teaches automatically
determining a target sample volume at an intersection of a trajectory of an
insertable instrument with the plane. Final Act. 5. The Examiner concludes
that
It would have been obvious to one of ordinary skill in the
art, having the teachings of Lazebnik and Gattani before him at
the time the invention was made to automatically determine a
target sample volume at an intersection of an insertable
instrument and a plane, as disclosed by Gattani, for the purpose
of assisting surgical procedures.
Final Act. 5.
Appellants contend that Gattani does not teach that the target anatomy
is unknown but rather the target anatomy in Gattani is known. App. Br. 4.
Appellants argue that in Gattani, the instrument path is the unknown factor.
App. Br. 5. Appellants argue that this in contrast with the current claims
wherein the spatial relationship between the trajectory of the instrument and
the plane scan data are known, but where the target sample volume is
unknown but is automatically calculated at the intersection of the trajectory
and the plane. App. Br. 5.
Findings of Fact
We adopt the Examiner’s findings as our own, including with regard
to the scope and content of, and motivation to modify or combine, the prior
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art. The following findings are included for emphasis and reference
purposes.
FI. Lazebnik discloses a method for visualizing an instrument path to
guide insertion of an instrument into a patient. Lazebnik 11.
FF2. Lazebnik teaches that internal ultrasound data is acquired for a
region of a patient’s body. Lazebnik 121.
FF3. The ultrasound data acquired in the method of Lazebnik can
include Doppler data which provides vascular flow information. Lazebnik 1
25.
FF4. Lazebnik teaches that the “target location is identified by the
user, such as through placement of a marker. In other embodiments, a
processor with or without input from the user identifies the target location.”
Lazebnik 128.
FF5. Lazebnik teaches that
BG :
Figure 1 of Lazebnik showing steps of the method.
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The acts shown in FIG. 1 [(above)] are performed in the
order shown or in a different order. Additional, different, or
fewer acts may be performed. For Example, act 40, may not be
used. As another example, act 44 may not be used. As another
example, act 44 is not provided. In another example, the
scanning of act 44 begins before receiving user configuration,
such as to provide an image for the user to refine or determine a
location of a region of interest.
Lazebnik ][ 15.
FF6. Gattani discloses a technique for computing and displaying
paths and associated attributes with a surgical instrument during endoscopic
surgery. Gattani 11.
FF7. The system of Gattani comprises
a data acquisition subsystem, a scope tracking subsystem, a
measurement subsystem, a data processing subsystem, a
registration subsystem and a user interface subsystem. The
purpose of the data acquisition subsystem is to load intra­
operative and pre-operative scan data representative of a region
of interest of a given patient. The purpose of the registration
subsystem is to bring the various data acquired into a common
coordinate space. The registration subsystem determines the
transformation parameters needed to coregister the data
acquired by the data acquisition subsystem and the tracking
subsystem to a common coordinate space. These parameters are
passed to the data processing subsystem, which transforms the
input data, performs segmentation and creates the desired
visualizations. The data processing subsystem is the main
processing subsystem of the VNS.
Gattani 160 (reference numbers omitted)
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FF8. In the system of Gattani, “[t]he measurement subsystem
receives user inputs and processed data via the data processing subsystem,
computes measurements of anatomical features, and formats the results to be
passed to the user interface subsystem for audio and/or visual output.”
Gattani 1 63.
FF9. The graphical model generator of Gattani generates surface
models of the region of interest including volumetric perspectives. Gattani
1173-75.
FF10. Gattani discloses a method to determine the intersection of a
plane in front of a probe based on the location of the probe and the
movement direction or trajectory of the probe. Gattani H 114—118, FIG. 17.
Fifi. 1*7
Annotated Figure 17 of Gattani showing determination of intersection of
trajectory with a plane.
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Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie
case of unpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant. After evidence or argument is submitted by the
applicant in response, patentability is determined on the totality
of the record, by a preponderance of evidence with due
consideration to persuasiveness of argument
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
“[Djuring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
Analysis
Claim 1 is representative of the rejected claims and is set forth above.
We agree with the Examiner that the subject matter of claim 1 would
have been obvious to one of ordinary skill in the art at the time the invention
was made over Lazebnik combined with Gattani. Lazebnik disclose a
method for visualizing the path of a surgical instrument. FF1. While the
method generally starts from a known point and then defines one or more
paths, Lazebnik teaches that the steps of the method can be performed in any
order. FF5. In addition Lazebnik teaches that the processor can define the
target location. Lazebnik also teaches that determining a region of interest
can be defined after the scanning of the patient has occurred. FF4. This
teaches that the data for a given plane can be acquired before the target
location is determined. Gattani discloses a method to calculate a point on a
plane in front of an instrument using the position and trajectory of the
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Application 13/570,136
instrument. FF10. This is similar to Appellants’ method where the location
of the target sample volume is calculated using the position of the instrument
and the trajectory of the instrument to calculate the point of intersection of
the trajectory with a selected plane. We agree with the Examiner that it
would have been obvious to combine the methods of Lazebnik with that of
Gattani to create the method claimed by Appellants.
Appellants and the Examiner are in conflict as the meaning of the
term “known” as used in the present claims. The Examiner finds that the
term is ambiguous. Ans. 19—21. Appellants argue that the term refers to
knowing or determining the location of an object or target. See, Reply Br. 3.
We agree with Appellants. The Specification teaches determining the
position of the target sample volume. Spec. 9—11. Thus it is the position of
the target which is unknown and is derived from the location of the
instrument, which is known and well as the trajectory of the instrument.
Appellants argue that Gattani is limited to a method where the
location of a target is known and that position is used to determine the path
or trajectory of the instrument. App. Br. 5. Appellants contrast the
teachings of Gattani with claim 1 which requires that the position and
trajectory are determined first and then the target volume is determined. Id.
We are unpersuaded,
As noted above, Gattani teaches that a point in a plane can be
determined from the location and trajectory of an instrument. FF10.
Lazebnik teaches that the location of the point of interest can be determined
automatically, FF4, and that the location of interest can be determined at any
stage, including after scanning has begun. FF5. Thus it is the combined
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Application 13/570,136
teachings of the references which renders the subject matter of the claims
obvious.
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 1 would have been obvious over Lazebnik
combined with Gattani. Claims 23—26, 28, 29, 51—53 and 55 have not been
argued separately and therefore fall with claim 1.
With respect to claims 2-4, 7—22, 30-32, 35,, and 36—50, 54, 56
Appellants only argument with respect to the patentability of these claims in
that the additional references do not remedy the deficiencies of Lazebnik and
Gattani. App. Br. 6—10. As discussed above, the teachings of Lazebnik and
Gattani are not deficient. We therefore affirm these rejections.
Lazebnik combined with Gattani, Spratt and Chen
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 5, 6, 33, and 34
would have been obvious over Lazebnik combined with Gattani, Spratt and
Chen.12
With respect to claims 5 and 33 the Examiner finds that Spratt teaches
that the flow characteristic value comprises a measure of pulsatility of flow
at the target sample volume, final Act. 13. The Examiner finds that Chen
discloses “computing the pulsatility through (Vmax - Vmin)/(Vmaxmean)
where Vmax is a peak systolic velocity, Vmin is a minimum forward
diastolic velocity in unidirectional flow and Vmaxmean is a maximum
12 Appellants incorrectly state the rejection as based on Lazebnik in view of
Spratt and in further view of Chen. App. Br. 7
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velocity averaged over at least one cardiac cycle.” Id. The Examiner
concludes “[i]t would have been obvious to one of ordinary skill in the art,
having the teachings of Lazebnik, Gattani, Spratt and Chen before him at the
time the invention was made to calculate pulsatility in this way because it is
well-known in the art that this is the way in which pulsatility is calculated.”
Id.
With respect to claims 6 and 34 the Examiner finds that Chen
discloses computing resistivity. Final Act. 13—14. The Examiner concludes
“[i]t would have been obvious to one of ordinary skill in the art, having the
teachings of Lazebnik, Gattani, Spratt and Chen before him at the time the
invention was made to calculate resistivity in this way because it is well-
known in the art that this is the way in which resistivity is calculated.” Final
Act. 14.
Appellants contend that Chen does not disclose the method recited in
the claims as Chen uses different variable to calculate pulsatility and
resistivity. App. Br. 7—8.
Findings of Fact
FF11. Claim 5 defines pulsatility as Vmax-Vmin/Vmax mean where Vmax is
a peak systolic velocity, Vmin is at least one of a minimum forward diastolic
velocity in a unidirectional flow or a maximum negative velocity in diastolic
flow reversal, and Vmax mean is a maximum velocity averaged over at least one
cardiac cycle. App. Br. 11—12 (Claims App’x.)
FF12. Claim 6 defines resistivity as Vmax/vmax-Vmin with Vmax and Vmm
as defined above. App. Br. 12 (Claims App’x.)
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FF13. The Specification teaches that various definitions of resistivity
and pulsatility are known and that the equations recited in the claims are
examples of the definitions. Spec. 13.
FF14. Spratt discloses
A method and apparatus for determining resistance and
pulsatility indices of a flow of material, such as the flow of
blood in the human body. This may be implemented, for
example, in a color flow module in an ultrasonic imaging
system for display of the resistance or pulsatility index in two
dimensions and in different colors to allow discrimination
between veins and arteries in a clinical survey mode of the
system. The resistance index is determined from the ratio of a
unipolar variation estimate of a velocity of the flow material
divided by peak velocity. The pulsatility index is determined
from the ratio of a unipolar or bipolar variation estimate of a
velocity of the flow of material divided by an average estimate
of the velocity of the flow of material.
Spratt col. 1,1. 63—col. 2,1. 8.
FF15. Spratt teaches that the variation estimate may defined as “a
difference between the peak velocity flow of the flow material and minimum
(if unipolar) or negative (if bipolar) velocity of the flow material.” Spratt
col.2,11. 9-12.
FF16. Chen discloses using pulsatility and resistivity to evaluate
blood vessel. Chen 922.
FF17. Chen defines pulsatility as the difference between peak systolic
velocity (“PSV”) and end diastolic velocity (“ESV”) divided by the mean
velocity. Id.
FF18. Chen defines resistivity as the difference between PSV and
ESV divided by PSV. Id.
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FF19. The Doppler data used by Chen to calculate the variables used
was collected over at least three separate, consecutive cardiac cycles. Id-
Analysis
We agree with the Examiner that the subject matter of claims 5, 6, 33,
and 34 would have been obvious to one skilled in the art at the time the
invention was made. As shown by Chen and Spratt, resistivity and
pulsatility can be used to evaluate ultrasonic data to evaluate blood vessels
and distinguish arteries from veins. FF14 and 15. Both Spratt and Chen
disclose methods for determining pulsatility and resistivity. FF14, 15, 17
and 18. In addition, the Specification teaches that a variety of definitions of
resistivity and pulsatility are known. FF13. It would have been obvious to
one skilled in the art to use pulsatility or resistivity to determine flow
characteristics of the target volume as called for in the claims.
Appellants argue that the references do not teach the specific
equations recited in the claims. App. Br. 7—8. With respect to pulsatility,
Appellants argue that Chen uses the lowest PSV value and that ESV is not a
minimum forward diastolic velocity in a unidirectional flow or a maximum
negative velocity in a diastolic flow reversal and that the time averaged
maximum velocity in Chen is not taken over at least one cardiac cycle. App.
Br. 7. As to resistivity, Appellants contend that Chen does not calculate
peak systolic velocity nor does Chen calculate a difference between systolic
and diastolic velocities. App. Br. 8, Reply Br. 4.
We have considered Appellants’ arguments and find them
unpersuasive. As the Specification teaches there are a variety of methods to
calculate pulsatility and resistivity and the equations used by Appellants are
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Application 13/570,136
just examples of the equations that can be used. FF13. Appellants have
merely chosen one of the different definitions of the terms. Absent a
showing that the equations recited in the claims produce an unexpected
result, the selection of the specific equation does not render the claims non-
obvious. See, e.g., KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)
(“[W]hen a patent claims a structure already known in the prior art that is
altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result.”).
Moreover, the method for calculating pulsatility recited in the claims 5 and
33 is taught by Spratt. FF14 and 15.
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claims 5, 6, 33, and 34 would have been obvious
over Lazebnik combined with Gattani, Spratt and Chen.
SUMMARY
We affirm the rejection under 35 U.S.C. § 101.
We affirm the rejections under 35 U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
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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