Ex Parte Carriazo

Patent Trial and Appeal Board

Apr 10, 2018

11913458 (P.T.A.B. Apr. 10, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111913,458 08/29/2008
3017 7590 04/10/2018
BARLOW, JOSEPHS & HOLMES, LTD.
101 DYER STREET
5THFLOOR
PROVIDENCE, RI 02903
FIRST NAMED INVENTOR
Cesar C. Carriazo
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.
H037 P01596-US 5355
EXAMINER
DOWNEY, JOHN R
ART UNIT PAPER NUMBER
3769
MAILDATE DELIVERY MODE
04/10/2018 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 PATENT TRIAL AND APPEAL BOARD
Ex parte CESAR C. CARRIAZO. 1
Appeal2017-003123
Application 11/913,458
Technology Center 3700
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, 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
method for controlling a laser during eye surgery which have been rejected
as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
STATEMENT OF THE CASE
Devices and methods for controlling a laser for eye surgery were
known.
1 Appellant identifies the Real Party in Interest as the applicant. Appeal Br.
1.
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Application 11/913,458
Spec. 1. The prior art describes a device for determining the portion of the
cornea to be ablated by using a pachymetric measurement of the portion of
the cornea to be removed. Id. One problem with the prior art methods is
that they represent only an approximation of the amount of cornea that needs
to be removed. Id. The Specification describes
Id.
a method for controlling a laser for eye surgery for the excision
or ablation of a corneal volume of a human or animal eye,
respectively, which calculates and represents an excision or
ablation volume of the cornea, respectively, optimized for the
respective purpose of use, and provides correspondingly
optimized control values to the laser.
Claims 9-11 and 13-16 are on appeal. Claim 9 is representative and
reads as follows:
9. A method for controlling a laser for eye surgery for the
ablation of a corneal volume of a human or animal eye,
respectively, wherein the method includes the following steps:
(a) acquiring measurement data concerning the thickness
of at least one part of the cornea by means of a measuring
device for measuring the cornea thickness;
(b) calculating a volume element for describing the
thickness of the measured parts of the cornea on the basis of the
measured data concerning the cornea thickness determined in
method step a) using one of volume describing functions and
interpolation;
( c) providing and entering data concerning a desired
depth, a diameter and a geometry of the corneal ablation;
( d) calculating a modified ablation volume using one of
volume-describing functions and interpolation with the data
according to method step c );
( e) representing the modified ablation volume using one
of volume-describing functions and interpolation;
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Application 11/913,458
(f) providing and entering data concerning correction
factors specific to the laser and to the cornea used for the
ablation of the cornea
(g) applying the correction factors acquired in f) to the
ablation volume calculated in d) and representing a resulting
ablation volume using one of volume-describing functions and
interpolation; and
(h) exporting the data calculated in method step g) for
calculation of a laser spot distribution for generating the
ablation volume calculated in method step g) taking into
consideration device-specific parameters of lasers for eye
surgery, wherein the device specific parameters are selected at
least from the group of scanner parameters, scanner resolution,
eye tracking parameters, eye tracking velocity, beam shape,
fluence and laser spot size; and exporting or transferring
calculated laser shot coordinates to the laser.
The claims have been rejected as follows:
Claims 9-11, 13, 14, and 16 have been rejected under 35 U.S.C. §
103(a) as unpatentable over Ruiz2 in view of D'Ippolito3, Kliewer4 and
Yousefi. 5
Claim 15 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Ruiz in view ofD'Ippolito, Kliewer and Youseffi in further view of
Carriazo. 6
DISCUSSION
Ruiz combined with D 'Ippolito, Kliewer and Youssefi
2 Ruiz, US 6,299,309 Bl, issued Oct. 9, 2001 ("Ruiz").
3 D'Ippolito, US 2004/0024389 Al, published Feb. 5, 2004 ("D'Ippolito").
4 Kliewer et al., US 6,572,606 B2, issued June 3, 2003 ("Kliewer").
5 Yousefi et al., US 2004/0002697 Al, published Jan. 1, 2004 ("Youseffi").
6 Carriazo, US 6,551,306 Bl, issued Apr. 22, 2003 ("Carriazo").
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Application 11/913,458
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that the subject matter of
claims 9--11, 13, 14, and 16 would have been obvious to one of ordinary
skill in the art at the time the invention was made over Ruiz combined with
D'Ippolito, Kliewer and Youseffi.
The Examiner finds that Ruiz discloses a method for ablating a
corneal volume of a human or animal eye which includes the steps of;
a) acquiring measurement data of a least one part of the cornea using
a device which measures the thickness of the cornea;
b) providing and entering data concerning the desired depth, the
diameter and geometry of the corneal ablation;
c) calculating a modified excision or ablation volume with the data
derived in step b)
d) representing the modified ablation volume;
e) providing and entering data concerning the correction factors
specific to the cornea to be ablated;
t) applying the correction factors acquire in e) to the ablation volume
calculated in step c) and representing the resulting ablation
volume; and
g) exporting the data calculated in step t); and exporting or
transferring the calculated laser shot coordinates to the laser.
Ans. 3--4.
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Application 11/913,458
The Examiner finds that D 'Ippolito discloses a method for ablating a
cornea which includes calculating a volume element for the cornea to be
ablated and then comparing the calculated volume to the desired volume.
Ans. 4--5. The Examiner finds that the difference between the volumes is
described using volume-describing functions. Ans. 5. The Examiner
concludes
it would have been obvious to one of ordinary skill in the art at
the time of the invention to modify the method and device
taught by Ruiz (which includes the ORBSCAN II device
capable of pachymetric measurements) to measure and
calculate a volume element of a patient's pre-operated cornea
and determining/calculating a modified ablation volume
measured as the difference between the original volume
element and a desired volume element because such a process
would provide a more precise evaluation of which tissue should
specifically be ablated to yield to optimal post-operative cornea.
It would have been further obvious in this modification that any
further representations of these values would be by volume-
describing functions, i.e. because the values being represented
are volumes.
Ans. 5.
The Examiner goes on to find that while the combination of Ruiz and
D 'Ippolito does not teach providing and entering correction factors for the
laser used, the use of such correction factors is taught by Kleiwer and
Y ousefi. Ans. 5-7.
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.
FF 1. Ruiz discloses "A system and method for correcting corneal
irregularities through reshaping of an eye's cornea to provide a desired
corrective corneal curvature." Ruiz Abstract.
Id.
FF2. A preferred embodiment of Ruiz includes
a topography device for mapping in detail the irregularities and
surface deviations of a cornea, an interface system for receiving
and manipulating topographical data and for providing
directions to a laser system or the like to carry out a
predetermined ablation profile on a substrate such as a corneal
stroma and for providing a variety of actual and simulated pre
and post-operative visual depictions.
FF3. The system of Ruiz uses an ORBSCAN II system which
"provides a digitized topography map based on elevation point taken at steps
10 microns along both the X and Y axis with an elevation resolution
generally ranging from 1-5 microns." Ruiz col. 11, 11. 35-38.
FF4. The apparatus of Ruiz
includes a topographical data acquisition means which receives
the corneal surface elevation map from the topographer. The
corneal topographical data which is acquired can be displayed
by the corneal surface display means. Preferably, this surface is
displayed as a color encoded surface elevation map. A best fit
sphere calculation means generates a spherical fit of the data
acquired by the topographical data acquisition means. The
spherical fit is performed along a chosen axis by the user or is
fit based on a pre-configured default axis. Based on the
acquired topographical data and the selected best fit sphere, a
reference ablation profile is generated and can be interactively
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modified to produce a surgically acceptable reference ablation
profile.
Ruiz col. 15, 11. 25-38.
FF6. The present Specification teaches "[i]n an advantageous
development of the method according to the invention, the calculation and
the representation of the excision or ablation volume, respectively, is
effected according to the method steps b ), d), e) and g) by Zernike
coefficients, matrices, point coordinates, best fit methods, Cartesian or polar
coordinates, vectors or vector coordinates or the like respectively." Spec. 4,
11. 8-12.
FF7. The system of Ruiz includes
An ablation profile selection, comparison and display
means [which] allows the user to select the type of ablation
profile to be displayed and considered for the ablation
procedure. One, two or more ablation profiles can also be
displayed so the user will have a visual comparison of the
profiles. A predicted corneal shape display means prepares and
displays the predicted corneal surface elevation maps that will
occur if the selected ablation profile(s) are applied to the
patient's cornea. The prediction is calculated by a subtraction of
the ablation profile from the corneal topographical data and can
include corrections based on physiological models of corneal
mechanical properties and corneal healing properties. If the
predicted corneal shape is satisfactory, the ablation profile is
written to the laser control data means to allow the corneal
ablation to be executed.
Ruiz col. 15, 11. 45-59.
FF8. The apparatus of D'Ippolito is "designed for defining, in a
unique and optimum manner, the position, area and volume of the corneal
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tissue to be removed by a laser ablating operation, in order to optimally
perform the ablating operation itself." D'Ippolito i-f 4.
FF9. The ablation volume in D'Ippolito is determined by taking the
difference between "the pachymetric map, as detected for the individual
patient by the pachymeter [], and the optimum pachymetric map of the bed
receiving the donor lens." D 'Ippolito i-f 21.
FFlO. D'Ippolito teaches that
The optimum contour or profile of the donor lens
receiving bed is defined by the operator by finding or detecting
the following parameters:
the center of the receiving bed;
the diameter of the receiving bed;
the minimum thickness at the center of the
receiving bed
the maximum thickness at the edge of the
receiving bed; and
the thickness variation along the diameter of
the receiving bed.
D'Ippolito i-fi-125-30.
FF 11. Kliewer discloses "a non-contact laser ablation method and
apparatus providing laser fluence compensation of a curved surface,
especially a corneal surface." Kliewer col. 1, 11. 17-19.
FF 12. Kliewer teaches that the "fluence is compensated for using
empirically measured or theoretical fluence correction factors given the
angle of the laser beam, size and shape of the ablation spot, etc." Kliewer
Abstract.
FF 13. Y ousefi discloses a laser correction ablation algorithm.
Y ouseffi Abstract.
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Application 11/913,458
FF 14. Y ousefi teaches
Parameters useful for the computation of the nominal
ablation include the size of the individual laser spot, its energy
profile (i.e., the change of intensity or energy of a laser spot as a
function of the radius), as well as the amount of tissue ablated
by one pulse (i.e., the rate of ablation).
Y ouseffi i-f 13.
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 ofunpatentability. 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).
"Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
isolation, but for what it fairly teaches in combination with the prior art as a
whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
"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'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "[W]hen the
question is whether a patent claiming the combination of elements of prior
art is obvious," the answer depends on "whether the improvement is more
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Application 11/913,458
than the predictable use of prior art elements according to their established
functions." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
Analysis
We find that the Examiner has established that the subject matter of
the claims would have been obvious over Ruiz combined with D 'Ippolito,
Kliewer and Y ouseffi. Appellant has not produced evidence showing or
persuasively argued that the Examiner's determinations on obviousness are
incorrect. Only those arguments made by the Appellant in the Briefs have
been considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). We have identified claim 9
as representative; therefore, claims 10, 11, 13, 14, and 16 fall with claim 9.
We address Appellant's arguments below.
Appellant argues that Ruiz does not teach step a of claim 9 which
calls for "acquiring measurement data concerning the thickness of at last
one part of the cornea by means of a measuring device for measuring
cornea thickness." Appeal Br. 4. While we agree with Appellant's
characterization of Ruiz, we are unpersuaded by Appellant's argument.
The rejection is based on the combined teachings of Ruiz, D'Ippolito,
Kliewer and Youseffi. D'Ippolito teaches taking a thickness measurement
of at least one part of the cornea. FFlO.
Appellant argues that D 'Ippolito does not teach using "one of volume
describing functions and interpolation." Appeal Br. 5. Appellant contends
that D'Ippolito calls for determining the ablation volume by calculating the
difference between the pachymetric map for the patient with an optimum
pachymetric map defined by the operator. Id. Appellant contends that this
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is not the same as using a volume describing function as called for in step d
of claim 9. Id.
We have considered Appellant's argument and find it unconvincing.
While D'Ippolito teaches that the operator selects the optimum pachymetric
map to be used in the calculation, as the Examiner points out, D 'Ippolito
teaches using that map to calculate the ablation volume using a volume
describing function. Ans. 12-13 FF9.
Appellant argues that the D 'Ippolito cannot be substituted into Ruiz
and it would render Ruiz's method superfluous. Appeal Br. 6. Appellant
contends that Ruiz and D'Ippolito used distinct and incompatible methods
for calculating their respective ablation volumes in that Ruiz uses a two
dimension model and D'Ippolito uses a three-dimension model. Appeal Br.
6, Reply Br. 1. Again we find Appellant's argument unconvincing.
Both Ruiz and D 'Ippolito teach calculating an ablation volume which
is then used to control a laser for ablation of a cornea. FFl and FF7. Ruiz
and D'Ippolito teach different methods for calculating their respective
ablation volumes. We agree with the Examiner that it would have been
obvious to one skilled in the art to use the ablation volume calculation
method of D 'Ippolito in the method of Ruiz as it would involve substituting
one known method for another to achieve the same purpose. Ans. 13. Other
than attorney argument, Appellant has offered no evidence or reasoning why
the ablation volume calculation method of D'Ippolito cannot be used in the
method of Ruiz. "Attorneys' argument is no substitute for evidence."
Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989).
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Appellant contends that neither Ruiz nor D 'Ippolito teach or suggest
using volume-describing functions and/or interpolation during both steps b)
and d). Appeal Br. 6. Specifically Appellant contends that neither reference
teaches calculating a modified ablation volume. Id.
We find Appellant's argument unpersuasive. Ruiz specifically
teaches determining a modified ablation volume. FF4.
With respect to the use of correction factors, Appellant argues that
Kliewer is not related to the present invention in that it dies not relate to the
calculation of volume elements. Appeal Br. 6-7. Appellant argues that
none of the references teach applying correction factors specific to both the
cornea and the laser. Appeal Br. 7. Finally, Appellant contends that
Youssefi does not teach applying laser correction factors to an ablation
volume. Appeal Br. 7-8.
Appellant's arguments are unpersuasive. Kliewer discloses a method
for controlling a laser to ablate a cornea. FF12. Thus Kliewer is relevant to
the claimed invention. Y ouseffi discloses applying correction factors to the
determination of ablation volumes for laser vision correction. FF13 and
FF14. Ruiz teaches the use of cornea specific correction factors for
determining an ablation volume. FF7. Thus the combined references teach
the use of correction factors based on both the laser used and the patient's
cornea.
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that the subject matter of claim 9 would have been
obvious over Ruiz combined with D 'Ippolito, Kliewer and Y ouseffi.
Ruiz combined with D 'Ippolito, Kliewer, Youseffi and Carriazo
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Appellant relies on the argument made above as grounds for reversing
this rejection. Appeal Br. 8. For the reasons stated above, we affirm this
rejection.
SUMMARY
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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