Ex Parte Clapham et al

Board of Patent Appeals and Interferences

Jun 23, 2009

10226867 (B.P.A.I. Jun. 23, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte TERRANCE N. CLAPHAM, MICHAEL COWPERTHWAITE,
RICHARD A. HOFER, and ERIK SCRAMAGLIA
__________

Appeal 2009-000559
Application 10/226,867
Technology Center 3700
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Decided:1 June 23, 2009
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to method of
positioning a patient during refractive eye surgery. The Examiner has

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
Appeal 2009-000559
Application 10/226,867

rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Claims 1-19 are on appeal. Claims 1 and 9 are representative and read
as follows:
Claim 1: A method of positioning a patient for refractive eye surgery,
the patient having first and second eyes, the method comprising:
supporting the patient on a patient seat, the patient seat being
contoured so as to align first and second eyes of the patient near a first axis
and a second axis, respectively;
positioning the patient in a first nominal position using a gross
adjustment mechanism, in the first nominal position the patient's first eye
being substantially aligned with a laser beam axis; and
automatically moving the patient to a second nominal position in
response to a nominal seat position signal, in the second nominal position,
the second axis being aligned with the laser beam axis and the patient's
second eye being substantially aligned with the laser beam axis so that the
patient's second eye is within a range of motion of a fine adjustment
mechanism.

Claim 9: The method of claim 1 wherein automatically positioning the
patient in a first nominal position comprises moving a patient seat from an
upright loading position to the first nominal position.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• claims 1-5, 7, 8, and 10-19 in view of Hohla,2 Sakita,3 and Yavitz;4
and
• claims 6 and 9 in view of Hohla, Sakita, Yavitz, and McDonnell.5

2 Hohla, WO 97/46184, Dec. 11, 1997.
3 Sakita, US 3,762,404, Oct. 2, 1973.
4 Yavitz, US 6,247,473 B1, Jun. 19, 2001.
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Appeal 2009-000559
Application 10/226,867

OBVIOUSNESS I
Issue
The Examiner has rejected claims 1-5, 7, 8, and 10-19 under 35
U.S.C. § 103(a) as being obvious in view of Hohla, Sakita, and Yavitz.
Claims 2-5, 7, 8, and 10-19 have not been argued separately and therefore
stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner finds that Hohla discloses “a method of positioning a
patient, … wherein rotating the seat into position under the laser head
constitutes the placing of the patient in a nominal position” (Answer 3),
Sakita discloses “a positioning aid employing a vacuum pillow” (id.), and
“Yavitz disclose[s] the treatment of both eyes of a patient” (id. at 3-4).
The Examiner concludes that it “would have been obvious to the
artisan of ordinary skill to employ the positioning method of Hohla … in the
method of Yavitz, since Yavitz teaches no particular method of positioning
the patient for surgery, or alternatively to conduct surgery on both eyes in
the method of Hohla … since there are patients that need refractive
correction in both eyes, as shown by Yavitz” (id. at 4). The Examiner also
concludes that it would have been obvious to the artisan of ordinary skill “to
substitute an automatic control system for the manual means of controlling
the seat position (see In re Venner, 262 F.2nd 91, 120 USPQ 193 (CCPA
1958)” (id.).
5 Myopic Photorefractive Keratectomy: U.S. Experience in: Color
Atlas/Text of Excimer Laser surgery: The Cornea, 1993, McDonnell and
Thompson, eds., Igaku-Shoin Medical Publishers, Inc., New York, New
York.
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Appellants contend that the Examiner erred in finding that the
combination of references suggests “a nominal seat position signal to affect
realignment of a laser from a first eye to a second eye” (Appeal Br. 7).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the combination of references
suggests automatic realignment of a laser from a first eye to a second eye in
response to a nominal seat position signal?
Findings of Fact
1. The Specification states that “[k]nown laser eye surgical alignment
systems typically have a patient seat or bed with the patient seated, lying
down, or reclined in a supine position. To align the patient with the laser
beam, the operator must manually adjust the seat or bed into alignment with
the laser.” (Spec., ¶ 7.)
2. The Specification states that the
control system will typically be programmed to automatically
move patient seat 24 from a loading position (Fig. 8D) to a first
nominal position (Fig. 8E). Preferably, the first nominal
position places the seat in a nominal “X”, nominal “Y”, and a
nominal “Z” position such that the seat is generally near the
center of the X, Y, and Z directions and the patient's first
optical axis 80 is substantially aligned with the laser beam axis
15. However, the first optical axis will not … always be
completely aligned with the laser beam axis 15. As long as the
nominal position is within the range of motion 65 of the laser
alignment system, the first optical axis 80 can be properly
aligned with the laser axis by making adjustments to the fine
adjustment mechanism.

(Id. at ¶ 73.)
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3. The Specification states that “[p]atient alignment system 11
preferably comprises a gross adjustment mechanism having an activating
motors [sic] to move the seat or bed in the X, Y and Z direction. The gross
adjustment mechanism … can be actuated by a signals from the control
system or manually actuated by a joystick.” (Id. at ¶ 66.)
4. The Specification states that “the fine adjustment mechanism can
be coupled to the patient seat to finely align the patients eye with the laser by
making minute adjustments to the seat. Preferably, … the same joystick and
activating motor are used, but the motor is adapted to move at a lower
speed.” (Id. at ¶ 67.)
5. The Specification states that
[p]referably, the control system can move the patient seat or
laser optics to a second nominal position so that the patient’s
second eye is completely aligned with the laser beam axis. If
the eye is not completely aligned with the laser, the operator
should not be required to manually realign the patient seat with
the gross adjustment mechanism, as the second position will
typically be in the range of motion of the fine adjustment
mechanism.
(Id. at ¶ 74.)
6. Hohla discloses an “excimer laser eye surgery system particularly
suited for laser in situ keratomileusis,” or LASIK (Hohla 1: 3-4, 18-19).
7. Figure 1 of Hohla is shown below:
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The figure shows a perspective view of Hohla’s laser system (id. at
2: 19).
8. Hohla discloses that a
patient bed enclosure 100 includes a patient bed 102 disposed
on top of it. … The control inputs 108, the keyboard 106, and
the display 110, all in conjunction with the computer system,
serve to control the laser system L, and to fire an excimer laser
beam through an optics path that extends … through an optical
extension 114. … The optical extension 114 directs the excimer
laser to the patient’s eye as the patient lies on the patient bed
102.
(Id. at 2: 31 – 3: 16.)
9. Hohla’s system includes “adjustment platform 125 [that] provides
motorized control of the patient bed 102 in the x, y, and z axes through the
controls 108” (id. at 4: 15-17).
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10. Hohla discloses that the “patient bed 102 rotates on a bearing 126.
… The patient bed 102 position is adjusted by motors and pulleys 140,
which provide x, y, and z axes control of the adjustment platform 125.” (Id.
at 4: 18-21.)
11. Hohla discloses that the “patient bed rotates sufficient so that the
head portion 124 of the patient bed 102 has rotated out from under the
optical extension 114. The patient can then sit up without striking his or her
head on the optical extension 114.” (Id. at 4: 22-25.)
12. Hohla discloses that the system comprises an aiming system that
comprises “a final beam directing portion extending horizontally over a
patient in an operational position, the final beam directing portion directing
the laser beam substantially perpendicular to the patient’s eye when the
patient is in the operational position” (id. at 9: 6-12).
13. Hohla discloses that the system “also includes an eye tracking
system . . . [that] works in conjunction with the computer system to maintain
the laser optics aligned with a desired point on the patient’s eye” (id. at
3: 12-16).
14. Yavitz discloses LASIK performed on both eyes of a patient
(Yavitz, col. 5, ll. 27-45).
Principles of Law
[T]he PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in the applicant’s specification.
In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
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“[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 than the predictable use of prior art elements according
to their established functions.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
417 (2007).
The obviousness analysis “can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” Id. at
418.
It is obvious to adapt a known product “using modern electronic
components in order to gain the commonly understood benefits of such
adaptation, such as decreased size, increased reliability, simplified operation,
and reduced cost.” Leapfrog Enterprises, Inc. v. Fisher-Price, Inc., 485 F.3d
1157, 1161 (Fed. Cir. 2007).
Analysis
Claim 1 is directed to a method of positioning a patient for refractive
eye surgery comprising supporting the patient on a seat contoured to align
the patient’s eyes near two axes, positioning the patient in a “first nominal
position” using a gross adjustment mechanism so that his first eye is
substantially aligned with a laser beam axis, and “automatically moving the
patient to a second nominal position” in which the patient’s second eye is
substantially aligned with the laser beam axis, with the movement occurring
in response to a nominal seat position signal.
The Specification does not expressly define the terms “first nominal
position,” “second nominal position,” “substantially aligned,” or “within a
range of motion of a fine adjustment mechanism.” However, the
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Specification describes a method of aligning a patient’s eyes for laser
surgery in which each of a patient’s eyes are sequentially aligned with a
laser beam axis closely enough that complete alignment can be achieved
using a fine adjustment mechanism (FFs 2, 5). The Specification also states
that the fine adjustment mechanism uses the same joystick and activating
motor as the gross adjustment mechanism, but the motor moves at a lower
speed (FFs 3, 4).
Read as broadly as is reasonable in light of the Specification,
therefore, claim 12’s first and second “nominal” positions are positions in
which each of a patient’s eyes are substantially aligned with the laser beam
axis; “substantially aligned,” in turn, means that the eye is aligned closely
enough that further gross adjustment is unnecessary and complete alignment
can be achieved using a fine adjustment mechanism that can use the same
activating motor but moves it at a different speed. Neither the claims nor the
Specification provide any numerical values for the distance that defines the
“range of motion of a fine adjustment mechanism.”
Hohla discloses a system for positioning a patient for laser eye
surgery that comprises positioning a patient on a bed having a head support
area that can align the patient’s eyes with the axis of a laser beam, and then
rotating the bed under a laser directing component so that a patient’s eye is
substantially aligned with a laser beam. Hohla discloses that its system
provides motorized control of the patient’s bed. Yavitz discloses laser eye
surgery performed on both of a patient’s eyes. In view of these disclosures,
it would have been obvious to one of skill in the art to modify Hohla’s
system to allow the seat/bed to position each of a patient’s eyes sequentially
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under the laser directing component, i.e., positioning the patient in first and
second nominal positions.
Hohla does not disclose “automatically moving the patient” so that the
patient’s second eye is aligned with the laser beam axis, but such a
modification would have been obvious to those of ordinary skill in the art:
Hohla teaches a system that includes motorized control of the patient’s bed,
and teaches that electronic components for automatically positioning a laser
with respect to a patient’s eye were known in the art. It would have been
obvious to modify the components disclosed by Hohla to automatically stop
the motorized movement of the patient’s bed at a position in which the laser
is correctly positioned with respect to the patient’s second eye, in order to
gain commonly understood benefits such as simplified operation. See
Leapfrog, 485 F.3d at 1161. Such a combination is no more than the
predictable use of prior art elements according to their established functions.
The disclosure of Sakita is cumulative.
Appellants argue that the Examiner erred in finding that the
combination of references suggests “seat contouring in combination with a
nominal seat position signal to limit fine movement of the patient” (Appeal
Br. 7). This limitation, however, is not part of claim 1.
Appellants argue that Hohla does not describe or suggest “activating a
control system to automatically move the seat (e.g. patient bed) to a first
nominal position in which the patient’s eye is substantially aligned with a
laser beam axis” (id.) and that Hohla indicates that the “x, y, and z control
adjustments would have to be gradually input for each eye of the patient”
(id. at 7-8; citing Hohla at 4: 15-21), which “is in distinct contrast to
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automatically positioning the patient in response to a nominal position signal
as recited in claim 1” (id. at 8).
This argument is not persuasive. First, claim 1 does not require the
patient to be automatically positioned in the first nominal position, only that
the patient is positioned in a first nominal position using a gross adjustment
mechanism. It does not include the limitation of “automatically mov[ing]
the seat (e.g. patient bed) to a first nominal position” that Appellants argue is
missing from Hohla.
The section of Hohla cited by Appellants states that the patient bed is
adjusted by motors and pulleys that provide x, y and z axes control (see FF 5
and 6), not that each eye would have to be gradually adjusted versus
automatically adjusted. To the contrary, Hohla discloses that its system
includes an eye tracking system that keeps the laser aligned with the
patient’s eye (FF 9). That disclosure, and the simplified operation resulting
from automating a process using modern electronic components, would have
suggested automatic movement of a patient to a second nominal position.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
combination of references suggests automatic realignment of a laser from a
first eye to a second eye in response to a nominal seat position signal.
OBVIOUSNESS II
Issue
The Examiner has rejected claims 6 and 9 under 35 U.S.C. § 103(a) as
being obvious in view of Hohla, Sakita, Yavitz, and McDonnell. Claim 6
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has not been argued separately and therefore stands or falls with claim 9.
37 C.F.R. § 41.37(c)(1)(vii).
The Examiner relies on Hohla, Sakita, and Yavitz as set forth above,
and finds that McDonnell discloses “seating a patient in a chair which is then
lowered into position beneath the microscope for surgery” (Answer 4). The
Examiner concludes that it “would have been obvious to the artisan of
ordinary skill to employ a chair, rather than a bed in the method of Hohla …
since a rotated chair would also fulfill the intended result of keeping the
patient from bumping the laser delivery mechanism with his or her head”
(id. at 4-5).
Appellants contend that the Examiner erred in finding the
combination of references to suggest the invention of claim 9 because there
is no motivation to combine the references to arrive at the claimed invention
(Appeal Br. 11).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that one of skill in the art would have
been motivated to combine the cited references and arrive at the invention of
claim 9?
Additional Findings of Fact
11. McDonnell is a text on Excimer Laser Surgery.
12. McDonnell states:
Once the patient is seated in the chair, a surgical head bonnet is
used to prevent hair from impeding the laser ablation (Fig. 3.5).
… The patient is then lowered into position under the micro-
scope until the eye to be treated is centered and in focus for the
surgeon (Figs. 3.7 and 3.8). The patient’s chin and head
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position should be adjusted and pressure applied to a “beanbag”
headrest to prevent any head movement during the procedure.
(McDonnell 41-42.)
Analysis
Claim 9 depends from claim 1 and further requires “moving a patient
seat from an upright loading position to the first nominal position.”
Hohla, Yavitz, and Sakita are discussed above. McDonnell discloses
that, in a laser surgery procedure, a patient may be first loaded in an upright
position and then lowered into position (i.e., to a first nominal position) for
the laser surgery procedure. In view of these disclosures, it would have been
obvious to one of ordinary skill in the art to include McDonnell’s contoured
seat/bed that could be loaded in the upright position in the system of Hohla
for positioning a patient under the laser directing component, i.e.,
positioning the patient in a first nominal position.
Appellants contend that McDonnell does not cure the deficiencies of
Hohla, Sakita, and Yavitz in suggesting the invention of independent claim
1, from which claim 9 depends, in which seat contouring is used in
combination with a nominal seat position (Appeal Br. 9).
This argument is not persuasive for the reasons discussed above.
Appellants also contend that there is no motivation to combine the
cited references to arrive at the invention of claim 9 (id. at 11).
This argument is not persuasive. The prior art discloses placing a bed
in a nominal position for laser eye surgery, as discussed above, and
McDonnell discloses loading a laser eye surgery patient in an upright chair
that is subsequently lowered for surgery. Thus, combining the nominal seat
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position with upright loading appears to be no more than the predictable use
of prior art elements according to their established functions.
Conclusions of Law
The evidence of record supports the Examiner’s conclusion that one
of skill in the art would have been motivated to combine the cited references
and arrive at the invention of claim 9.
SUMMARY
We affirm the rejection under 35 U.S.C. § 103(a) of claims 1-5, 7, 8,
and 10-19 in view of Hohla, Sakita, and Yavitz and of claims 6 and 9 in
view of Hohla, Sakita, Yavitz and McDonnell.
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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