DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 21-22 are new.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ichikawa (JP 2010035729 A) in view of Brown et al. (US 20150216408 A1) and Frey (US 5442412 A).
Regarding claim 1, Ichikawa discloses in at least figures 1-2, a retinal camera system (fundus
camera paragraph [0010]), comprising:
a housing (imaging unit 3 fig. 1);
an eyepiece lens (objective lens 25 fig. 2) disposed within (figure 2 is a configuration of an
optical system housed in the imaging unit 3 paragraph [0014]) the housing {imaging unit 3 fig. 1);
a retinal image sensor (imaging element 38 fig. 2) optically coupled (imaging element 38 is
optically coupled to objective lens 25 along optical axis L1 fig. 2) to the eyepiece lens (objective lens 25
fig. 2) to acquire a retinal image (fundus observation image paragraph [0020]) of an eye of a human (eye
E fig. 2) examinee (a fund us image of a subject's eye paragraph [0014] of translation) through the
eyepiece lens (objective lens 25 fig. 2);
and a visual guidance indicator (alignment index projection optical system 50 fig. 2) disposed in
(figure 2 is a configuration of an optical system housed in the imaging unit 3 paragraph [0014]) or on the
housing (imaging unit 3 fig. 1) peripherally about (the alignment index projection optical system 50 is
peripherally about the objective lens 25 fig. 2) the eyepiece lens (objective lens 25 fig. 2),
the visual guidance indicator (alignment index projection optical system 50 fig. 2) positioned and
oriented relative to (the optical system 50 surrounds the objective lens 25 fig. 2) the eyepiece lens
(objective lens 25 fig. 2) to emit light along an optical path (the light emitted from infrared light sources
51 and 53 is on a different optical path than objective lens 25 fig. 2) that does not pass through (the light
emitted from infrared light sources 51 and 53 does not pass through objective lens 25 fig. 2) the
eyepiece lens (objective lens 25 fig. 2).
Ichikawa does not disclose, the visual guidance indicator positioned and oriented relative to the
eyepiece lens to emit a visual cue along an optical path that does not pass through the eyepiece lens,
wherein the visual cue adapted to facilitate an alignment of the eye to the eyepiece lens,
wherein the visual cue is visible to the eye when the eye is misaligned to the eyepiece lens and
adapted to provide visible feedback to the eye that guides the human examinee to reposition eye into
an alignment with the eyepiece lens for retinal imaging of the eye being aligned by the visual cue to the
eyepiece lens.
However Brown discloses in at least figure 8, the visual guidance indicator (PAM 1322 fig. 8) positioned and oriented relative to (the PAM 1322 is positioned relative to the scan relay 1320 fig. 8) the eyepiece lens (scan relay fig. 8) to emit (the PAM 1322 provides a patient fixation target via projection of an optical signal which may, for example, be visible LEDs 1326 paragraph [0137]) a visual cue (visible LEDs 1326 fig. 8) along an optical path (LED path as show below in fig. 8) that does not pass through (the LED path does not pass through the scan relay 1320 as shown below in fig. 8) the eyepiece lens (scan relay 1320 fig. 8).
PNG
media_image1.png
530
854
media_image1.png
Greyscale
Therefore it would be obvious for one skilled in the art before the effective filling date of the claimed invention to use a visual guidance indicator that does not pass through the eyepiece lens as taught by Brown in the fundus camera of Ichikawa. It is also possible to acquire a targeted OCT image within the wide field retinal context (paragraph [0138]).
Additionally Frey discloses in at least figures 4-5, wherein the visual cue (light dots 350-357 fig. 5) is visible to the eye (the patient's eye will perceive the particular directional light dot at infinity col. 7 lines 19-20) when the eye (eye 10 fig. 4) is misaligned to (eye movement along a direction indicated by arrow 50 that is exactly between dots 350 and 351 col. 7 lines 9-14) the eyepiece lens (lens 400 fig. 4) and adapted to provide visible feedback (either of dots 354 or 355 could be lit col. 7 lines 9-14) to the eye (eye fig. 4) that guides the human examinee to reposition (move the eye's focus opposite to direction 50 col. 7 lines 9-14) eye (eye 10 fig. 4) into an alignment with (towards dot 30 col. 7 lines 9-14) the eyepiece lens (lens 400 fig. 4) for retinal imaging (taught above by Ichikawa) of the eye (eye 10 fig. 4) being aligned by (the eye 10 focuses through lens 400 and focuses on dot 30 col. 5 lines 52-53) the visual cue (light dots 350-357 fig. 5) to the eyepiece lens (lens 402 fig. 4).
Therefore it would be obvious for one skilled in the art before the effective filling date of the claimed invention to use visible feedback for alignment as taught by Frey in the fundus camera of Ichikawa. To increase the precision of the directional feedback, additional directional LED's can be added (col. 7 lines 1-7).
Regarding claim 3, the combination of Ichikawa, Brown and Frey discloses all the limitations of claim 1 and Ichikawa further discloses, wherein the plurality of emission locations (a plurality of light sources 51 and 53 fig. 2) form two concentric rings (the light sources 51 and 53 that form a concentric ring fig. 2) extending around (the two light sources 51 and 53 extend around the objective lens 25 fig. 2) the eyepiece lens (objective lens 25 fig. 2).
Regarding claim 21, the combination of Ichikawa, Brown and Frey discloses all the limitations of claim 1, and Ichikawa further discloses, wherein the visual guidance indicator (alignment index projection optical system 50 fig. 2) is configured to provide coarse alignment guidance (the light sources 51 and 53 surround the objective lens 25 to align eye E with the objective lens 25 with an alignment index beam paragraph [0022] imaged by alignment camera imaging element 65 paragraph [0023] described in the current application as alignment tracking cameras proving coarse alignment paragraph [0026]) before fine alignment (the fixation target guides the gaze of the subject paragraph [0008] described in the current application as the fixation target image guiding the patient's gaze into fine or precise alignment in paragraph [0028]) through the eyepiece lens (objective lens 25 fig. 2) the eye (eye E fig. 2).
Ichikawa does not disclose, wherein the visual guidance indicator is visible to the eye.
However Brown further discloses, wherein the visual guidance indicator (PAM 1322 fig. 8) is visible to (the PAM 1322 provides a patient fixation target via projection of an optical signal which may, for example, be visible LEDs 1326 paragraph [0137]) the eye (eye 1324 fig. 8).
Therefore it would be obvious for one skilled in the art before the effective filling date of the claimed invention to use a visual guidance indicator that does not pass through the eyepiece lens as taught by Brown in the fundus camera of Ichikawa. It is also possible to acquire a targeted OCT image within the wide field retinal context (paragraph [0138]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ichikawa (JP 2010035729 A)
in view of Brown et al. (US 20150216408 A1) and Frey (US 5442412 A) as applied to claim 1 above and in further view of Abramoff (US 20180064337 Al).
Regarding claim 2, the combination of Ichikawa, Brown and Frey discloses all the limitations of claim 1 and Ichikawa further discloses, wherein the visual guidance indicator (alignment index projection optical system 50 fig. 2) comprises a plurality of emission locations (a plurality of light sources 51 and 53 fig. 2) disposed about (the light sources 51 and 53 are disposed about the objective lens 25 fig. 2) the eyepiece lens (objective lens 25 fig. 2).
Ichikawa does not disclose, a plurality of emission locations from which the eye can reference
the alignment with the eyepiece lens.
However Abramoff discloses, a plurality of emission locations (there are a plurality of guide
lights 4 fig. 5) from which the eye (eye 2 fig. 4A) can reference the alignment (all the guide lights are
visible to the subject when optimally positioned and aligned along the x and y axis paragraph [0034])
with the eyepiece lens (objective lens of camera 6 fig. 5).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to use the visual cue as taught by Abramoff in the alignment index projection of
Ichikawa. All of the guide lights are visible to the subject when alignment is achieved (paragraph [0034]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ichikawa (JP 2010035729 A)
in view of Brown et al. (US 20150216408 A1) and Frey (US 5442412 A) as applied to claim 1 above and in further view of Okamoto (JP 2002102173 A).
Regarding claim 4, the combination of Ichikawa, Brown and Frey discloses all the limitations of claim 1.
Ichikawa does not disclose, wherein the housing comprises a lens tube including the eyepiece
lens and wherein the visual guidance indicator is disposed on a distal exterior end of the lens
tube and facing outwards to present the eye with the visual cue.
However Okamoto discloses in at least figures 1-2, wherein the housing (microscope system 6
fig. 2) comprises a lens tube (lens barrel main body 9 fig. 2) including the eyepiece lens (objective lens 31
fig. 2) and wherein the visual guidance indicator (LEDs LI-L16 are light sources arranged around the
objective lens 31 paragraph [0037], the alignment device with light sources around the objective lens is
previously disclosed above by Ichikawa) is disposed on a distal exterior end (end surface 9B fig. 2) of the
lens tube (lens barrel main body 9 fig. 2) and facing outwards (the end surface 9B faces the jaw support
10 fig. 2 which is the same side as the eye E fig. 1) to present the eye (eye E fig. 1) with the visual cue
(LEDs LI-L16 emit light to the eye paragraph [0032], the visual cue for alignment is disclosed above by
Abramoff).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to use a lens tube as taught by Okamoto for the objective lens and alignment device
of Ichikawa. The lights arranged around the objective lens on the lens barrel saves space (paragraph
[0032]).
Claims 5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over
Ichikawa (JP 2010035729 A) in view of Brown et al. (US 20150216408 A1) and Frey (US 5442412 A) as applied to claim 1 above and in further view of Sakai (US 10149615 B2).
Regarding claim 5, the combination of Ichikawa, Brown and Frey discloses all the limitations of claim 1 and Ichikawa further discloses, further comprising a controller (control unit 80 fig. 2) communicatively coupled (control unit 80 is connected to imaging elements 38 and 65 paragraph [0026], the light from alignment index projection optical system 50 is reflected to imaging element 65) to the visual guidance indicator (alignment index projection optical system 50 fig. 2) and the retinal image sensor (imaging element 38 fig. 2).
Ichikawa does not explicitly disclose, the controller including logic that when executed by the
controller causes the retinal camera system to perform operations including:
dynamically altering one or more of a brightness of the visual cue, a shape-pattern of the visual
cue, a temporal-pattern of the visual cue, or colors of the visual cue to aid the alignment of the eye to
the eyepiece lens.
However Sakai discloses in at least figures 6-7, the controller (control circuit 27 fig. 7) including
logic that when executed (the control circuit 27 is provided with a program for controlling the
illumination light source 20, MEMS mirror 23 and fundus forming image unit 29 col. 8 lines 6-10) by the
controller (control circuit 27 fig. 27) causes the retinal camera system (ophthalmoscope body 1 fig. 6) to
perform operations including:
dynamically altering (the control circuit 27 controls the MEMS mirror 23 to change the scanning
locus at the time of alignment col. 10 lines 55-59) one or more of, a brightness (the brightness in uneven
on one side of the fund us until alignment is achieved col. 9 lines 52-67) of the visual cue (alignment
indicator col. 10 line 17), and a shape-pattern (the circular locus displayed on the screen is not fully
shown until alignment is achieved col. 10 lines 27-39) of the visual cue (alignment indicator col. 10 line
17).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to use the visual guidance indicator, to alter the brightness and shape of the visual
cue, as taught by Sakai as part of the housing peripherally about the eyepiece of Ichikawa. When the
apparatus body is misaligned the light spots are missing in one corner of the eye which lets the examiner
know which direction to move the body (col. 11 lines 27-34).
Regarding claim 7, the combination of Ichikawa, Brown, Frey and Sakai discloses all the limitations of claim 5 and Ichikawa further discloses, further comprising:
a display (monitor 8 fig. 2) communicatively coupled (the monitor 8 is coupled to the control
unit 80 fig. 2) to the controller (control unit 80 fig. 2), the display (monitor 8 fig. 2) optically coupled to
the eyepiece lens (objective lens 25) to emit a fixation target (fixation target paragraph [0024]) to the
eye (eye E fig. 2) through the eyepiece lens (objective lens 25),
wherein the visual guidance indicator (alignment index projection optical system 50 fig. 2) is
adapted to facilitate a coarse alignment (the light sources 51 and 53 surround the objective lens 25 to
align eye E with the objective lens 25 with an alignment index beam paragraph [0022] imaged by
alignment camera imaging element 65 paragraph [0023] described in the current application as
alignment tracking cameras proving coarse alignment paragraph [0026]) between the eye (eye E fig. 2)
and the eyepiece lens (objective lens 25 fig. 2) to guide the eye into a sufficient alignment (the light
sources 51 and 53 surround objective lens 25 to align eye E with the objective lens 25 with an alignment
index beam paragraph [0022] and the fixation target is presented to fix the subjects eye paragraph
[0024]) to see the fixation target (fixation target paragraph [0024]) and the fixation target (fixation
target paragraph [0024]) is adapted to then facilitate a fine alignment (the fixation target guides the
gaze of the subject paragraph [0008] described in the current application as the fixation target image
guiding the patient's gaze into fine or precise alignment in paragraph [0028]) between the eye (eye E fig.
2) and the eyepiece lens (objective lens 25 fig. 2) for retinal imaging (fundus observation image
paragraph [0020]) with the retinal image sensor (imaging element 38 fig. 2).
Regarding claim 8, the combination of Ichikawa, Brown, Frey and Sakai discloses all the limitations of claim 5 and Ichikawa further discloses, the camera further comprising:
an alignment tracking camera (imaging element 65 serves as an imaging means for detecting
alignment paragraph [0023]) communicatively coupled (control unit 80 is connected to imaging
elements 38 and 65 paragraph [0026]) to the controller (controller 80 fig. 2), disposed peripherally
(imaging element is disposed peripherally to objective lens 25 fig. 2) to the eyepiece lens (objective lens
25 fig. 2), and positioned to provide pupil or iris tracking (pupil position is detected by imaging element
65 paragraph [0060]) of the eye (eye E fig. 2), wherein the controller (controller 80 fig. 2) includes
further logic (the control unit detects an alignment shift and outputs a drive signal based on the
detection result paragraph [0056]) that when executed by the controller (controller 80 fig. 2) causes the
retinal camera system (fundus camera paragraph [0010]) to perform additional operations including:
tracking a relative position (the tracking control for the eye is based on the alignment reference
position paragraph [0056]) of the eye (eye E fig. 2) to the eyepiece lens (objective lens 25 fig. 2).
Ichikawa does not explicitly disclose, dynamically altering the visual cue based on the tracking to
provide feedback guidance to the eye for achieving the alignment, wherein the feedback guidance
includes cues visually instructing a user to move the eye relative to the eyepiece lens in a lateral
direction or an eye relief direction.
However Sakai discloses in at least figures 10-12, dynamically altering (when misaligned
illumination light fluxes from the light source 20 col. 9 lines 30-33) the visual cue (illumination light col. 9
line 47) based on the tracking (when alignment is not achieved the brightness is uneven on one side of
the fundus col.9 lines 44-67) to provide feedback guidance (the brightness col.9 lines 44-67) to the eye
(subject eye Ecol. 9 fig. 10) for achieving the coarse alignment (when alignment is achieved there is no
unevenness in brightness col.9 lines 44-67), wherein the feedback guidance (the brightness col. 9 lines
44-67) includes cues visually instructing a user (illumination light col. 9 line 47) to move the eye (eye E
col. 9 fig. 10) relative to (as the eye becomes aligned with the eyepiece the brightness displayed
becomes even lines 44-67) the eyepiece lens (objective lens 25 fig. 7) in a lateral direction (direction
perpendicular to the optical axis col. 9 line 63) or an eye relief direction (optical axis direction col. 9 line
63).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to alter the visual cue as taught by Sakai in the alignment tracking of Ichikawa. When
the apparatus body is misaligned the light spots are missing in one corner of the eye which lets the
examiner know which direction to move the body (col.11 lines 27-34).
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ichikawa (JP
2010035729 A) in view of Brown et al. (US 20150216408 A1), Frey (US 5442412 A) and Sakai (US 10149615 B2) as applied to claim 5 above and in further view of Mizuochi (US 20060126017 Al).
Regarding claim 6, the combination of Ichikawa, Brown, Frey and Sakai discloses all the limitations of claim 5 and Sakai further discloses, wherein the controller (control circuit 27 fig. 7) includes further logic that when executed (the control circuit 27 is provided with a program for controlling the illumination light source 20, MEMS mirror 23 and fundus forming image unit 29 col. 8 lines 6-10) by the controller (control circuit 27 fig. 7) causes the retinal camera system (ophthalmoscope body 1 fig. 6) to perform additional operations including:
emitting the visual cue (alignment indicator col. 10 line 17) to aid a coarse alignment (the
alignment indicator is displayed on LCD screen 5 to aid in alignment col 10 line 10-26) of the eye (subject
eye Ecol. 10 line 11) to the eyepiece lens (objective lens 25 fig. 7).
Sakai does not explicitly disclose dimming or disabling the visual cue in advance of acquiring the
retinal image of the eye.
However Mizuochi discloses in at least figure 1, dimming or disabling (the red-light LED of the
alignment index light source 60 is dimmed paragraph [0040)]) the visual cue (red-light LED of the
alignment index light source 60 fig. 1) in advance of acquiring (during the observation the alignment
index light source is dimmed paragraph [0040]) the retinal image (the observation is recorded on film 44
paragraph [0040] of the eye (eye E fig. 1).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to dim the visual cue as taught by Mizuochi in the alignment indicator of Ichikawa.
The dimming of the visual cue allows of infrared light to be emitted paragraph [0040]).
Regarding claim 9, the combination of Ichikawa, Brown, Frey and Sakai discloses all the limitations of claim 8 and Ichikawa further discloses, wherein the controller (control unit 80 fig. 1) includes further logic (imaging element 65 is connected to the control unit paragraph [0026]) that when executed by the controller (control unit 80 fig. 1) causes the retinal camera system (fundus camera paragraph [0010]) to perform additional operations (the control unit detects the misalignment of the imaging unit 3 with respect to the eye based on the light reception output from imaging element 65 paragraph [0026])
including:
illuminating (alignment index projection optical system 50 projects a light beam on the eye that
is detected by image sensor 65 paragraph [0023]) the eye (eye E fig. 2) with the visual guidance
indicator (alignment index projection optical system 50 fig. 1);
and acquiring an anterior segment image (optical system 60 images the anterior of the eye
paragraph [0023]) of the eye (eye E fig. 2) with at least one of (optical system 60 images the anterior of
the eye with imaging element 65 paragraph [0023]) the alignment tracking camera (imaging element 65
serves as an imaging means for detecting alignment paragraph [0023]) or the retinal image sensor while
using the visual guidance indicator (alignment index projection optical system 50 fig. 1) to provide
illumination (alignment index projection optical system 50 projects a light beam on the eye that is
detected by image sensor 65 paragraph [0023]) for the anterior segment image (optical system 60
images the anterior of the eye paragraph [0023]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ichikawa (JP
2010035729 A) in view of Brown et al. (US 20150216408 A1), Frey (US 5442412 A) and Sakai (US 10149615 B2) as applied to claim 8 above and in further view of Niece (US 20160192837 A1).
Regarding claim 10, the combination of Ichikawa, Brown, Frey and Sakai discloses all the
limitations of claim 8 and Ichikawa further discloses, wherein the controller (control unit 80 fig. 1)
includes further logic (imaging element 65 is connected to the control unit paragraph [0026]) that when
executed by the controller (control unit 80 fig. 1) causes the retinal camera system (fundus camera
paragraph [0010]) to perform additional operations (the control unit detects the misalignment of the
imaging unit 3 with respect to the eye based on the light reception output from imaging element 65
paragraph [0026]) including:
illuminating (alignment index projection optical system 50 projects a light beam on the eye that
is detected by image sensor 65 paragraph [0023]) the eye (eye E fig. 2) with the visual guidance indicator
(alignment index projection optical system 50 fig. 1).
Ichikawa does not explicitly disclose, varying an intensity of the illuminating and measuring
pupillary reactions to the varying of the intensity with at least one of the alignment tracking camera or
the retinal image sensor to perform pupillometry testing of a pupil of the eye.
However Neice discloses in at least figures 1-6, varying an intensity of the illuminating (radiation
source at fluctuating intensities paragraph [0049]);
and measuring pupillary reactions (pupil reflex response paragraph [0049]) to the varying of the
intensity (radiation source at fluctuating intensities paragraph [0049]) with at least one of the alignment
tracking camera or the retinal image sensor (digital camera paragraph [0043] retinal image sensor
taught above by Ichikawa) to perform pupillometry testing (pupil reflex response paragraph [0049]) of a
pupil of the eye (pupil paragraph [0049]).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to add the functions of varying the intensity of the illumination to measure
pupillometry as taught by Neice to the controller of Ichikawa to be executed using the image sensors.
Claims 11-12 are rejected as being unpatentable over Ichikawa (JP 2010035729 A) in view of Brown et al. (US 20150216408 A1), Frey (US 5442412 A) and Sakai (US 10149615 B2) as applied to claim 8 above and in further view of Shalon et al. (US 5585873 A).
Regarding claim 11, the combination of Ichikawa, Brown, Frey and Sakai discloses all the limitations of claim 8.
Ichikawa does not disclose, wherein the controller includes further logic that when executed by
the controller causes the retinal camera system to perform additional operations including:
sequentially activating different angular positions of the visual guidance indicator about the
eyepiece lens to illuminate the eye from the different angular positions;
observing reflections off a cornea of the eye with at least one of the alignment tracking camera
or the retinal image sensor;
and determining a surface curvature of the cornea based upon the reflections.
However Shalon discloses in at least figures 1-2, wherein the controller (computer 22 fig. 1)
includes further logic (computer 22 can be used to program the keratometer 10 col. 6 lines 61-62) that when executed by the controller (computer 22 fig. 1) causes the retinal camera system to perform additional operations including:
sequentially activating (alignment is facilitated by projecting a pattern of collimated light
sources on to the eye col. 8 lines 15-17) different angular positions (the angles of the beam are known
with respect to the optical axis col. 8 lines 33-34) of the visual guidance indicator (fixation light col. 8 line
24) about the eyepiece lens (eyepiece 34 fig. 1) to illuminate (light sources illuminate the eye col. 8 line
28-29) the eye (patients eye col. 8 line 27) from the different angular positions (a light is used as a
fixation target at know angles onto the patient's eye col. 8 lines 24-37);
observing reflections off a cornea of the eye (reflected from the cornea col. 8 line 25) with at
least one of the alignment tracking camera (alignment is facilitated by projecting a pattern of
collimated light sources on to the eye col. 8 lines 15-17 and reflected to camera which includes what is
called a CCD imager col. 8 lines 42-43) or the retinal image sensor;
and determining a surface curvature of the cornea (radius of curvature of the cornea col. 8 lines
34-37) based upon the reflections (images reflected from the cornea can be used to derive the radii of
curvature and major and minor axis angles of the cornea col.8 lines 33-37).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to add the function of observing reflections of the cornea to obtain the curvature as
taught by Shalon to the image sensors and controller of Ichikawa. Observing the cornea will allow the
examiner to such things as keratoconus, dystrophies, and stigmatism, corneal problems, and abnormal
curvature (col. 1 lines 27-31).
Regarding claim 12, the combination of Ichikawa, Brown, Frey and Sakai discloses all the limitations of claim 8.
Ichikawa does not disclose, wherein the controller includes further logic that when executed by
the controller causes the retinal camera system to perform additional operations including:
activating the visual guidance indicator to illuminate the eye with a reference pattern;
capturing a reflection of the reference pattern off of a cornea of the eye with at least one of the
alignment tracking camera or the retinal image sensor and analyzing the reflection to determine a
surface curvature of the cornea.
However Shalon discloses in at least figures 1-2, wherein the controller (computer 22 fig. 1)
includes further logic (computer 22 can be used to program the keratometer 10 col. 6 lines 61-62) that
when executed by the controller (computer 22 fig. 1) causes the retinal camera system to perform
additional operations including:
activating the visual guidance indicator (fixation light col. 8 line 24) illuminate (light sources
illuminate the eye col. 8 line 28-29) the eye (patients eye col. 8 line 27) with a reference pattern (the
angles of the light beams are known and are used as reference to measure the radii of curvature of the
cornea col. 8 lines 33-37);
capturing a reflection (reflected from the cornea col. 8 line 25) of the reference pattern (the
angles of the light beams are known and are used as reference to measure the radii of curvature of the
cornea col. 8 lines 33-37) off of a cornea of the eye (reflected from the cornea col. 8 line 25) with at least
one of the alignment tracking camera (alignment is facilitated by projecting a pattern of collimated light
sources on to the eye col. 8 lines 15-17 and reflected to camera which includes what is called a CCD
imager col. 8 lines 42-43) or the retinal image sensor;
and analyzing the reflection to determine a surface curvature of the cornea (images reflected
from the cornea can be used to derive the radii of curvature and major and minor axis angles of the
cornea (col.8 lines 33-37 by camera means 78 col. 9 lines 39-51).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to add the function of observing reflections of the cornea using a reference pattern to
obtain the curvature as taught by Shalon to the image sensors and controller of Ichikawa.
Observing the cornea will allow the examiner to such things as keratoconus, dystrophies, and
stigmatism, corneal problems, and abnormal curvature (col. 1 lines 27-31).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ichikawa (JP 2010035729
A) in view of Brown et al. (US 20150216408 A1), Frey (US 5442412 A) and Umeji (WO 2015102092 A1).
Regarding claim 13, Ichikawa discloses in at least figures 1-2, a method for imaging an eye of a
human examinee (the fundus camera includes an imaging system for imaging the eye paragraph [0008]),
the method comprising:
emitting a fixation target (fixation target paragraph [0024]) through an eyepiece lens (objective
lens 25 fig. 2) towards the eye (eye E fig. 2),
wherein the fixation target (fixation target paragraph [0024]) facilitates a fine alignment (the
fixation target guides the gaze of the subject paragraph [0008] described in the current application as
the fixation target guiding the patient's gaze into fine or precise alignment in paragraph [0028]) between
the eye (eye E fig. 2) and the eyepiece lens (objective lens 25 fig. 2);
emitting a visual cue from a visual guidance indicator (alignment index projection optical system
50 fig. 2) surrounding an exterior side (the alignment index projection optical system 50 surrounds the
exterior of the objective lens 25 fig. 2) of the eyepiece lens (objective lens 25 fig. 2),
wherein the light does not pass through (the light emitted from infrared light sources 51 and 53
does not pass through objective lens 25 fig. 2) the eyepiece lens (objective lens 25 fig. 2),
capturing a retinal image (fund us observation image paragraph [0020]) of the eye (eye E fig. 2)
through the eyepiece lens (objective lens 25 fig. 2) with a retinal image sensor (imaging element 38 fig. 2).
Ichikawa does not disclose, wherein the visual cue does not pass through the eyepiece lens and
is visible to the eye when the eye is misaligned to the eyepiece lens to provide visible feedback that
guides the human examinee to reposition the eye into a coarse alignment with the eyepiece lens to
observe the fixation target;
wherein the retinal image is captured after achieving the coarse alignment of the eye to the
eyepiece lens with the visual cue and after the fine alignment of the eye to the eyepiece lens with the
fixation target.
However Brown discloses in at least figure 8, wherein the visual cue (visible LEDs 1326 fig. 8) does not pass through (the LED path does not pass through the scan relay 1320 as shown below in fig. 8) the eyepiece lens (scan relay 1320 fig. 8).
PNG
media_image1.png
530
854
media_image1.png
Greyscale
Therefore it would be obvious for one skilled in the art before the effective filling date of the claimed invention to use a visual guidance indicator that does not pass through the eyepiece lens as taught by Brown in the fundus camera of Ichikawa. It is also possible to acquire a targeted OCT image within the wide field retinal context (paragraph [0138]).
Additionally Frey discloses in at least figures 4-5 the visual cue (light dots 350-357 fig. 5) is visible to (the patient's eye will perceive the particular directional light dot at infinity col. 7 lines 19-20) the eye (eye 10 fig. 4) when the eye (eye 10 fig. 4) is misaligned to (eye movement along a direction indicated by arrow 50 that is exactly between dots 350 and 351 col. 7 lines 9-14) the eyepiece lens (lens 400 fig. 4) to provide visible feedback (either of dots 354 or 355 could be lit col. 7 lines 9-14) that guides the human examinee to reposition (move the eye's focus opposite to direction 50 col. 7 lines 9-14) the eye (eye 10 fig. 4) into an alignment with (towards dot 30 col. 7 lines 9-14) the eyepiece lens (lens 400 fig. 4).
Therefore it would be obvious for one skilled in the art before the effective filling date of the claimed invention to use visible feedback for alignment as taught by Frey in the fundus camera of Ichikawa. To increase the precision of the directional feedback, additional directional LED's can be added (col. 7 lines 1-7).
Further Umeji discloses, into a coarse alignment (the alignment system 16 has a function of
performing alignment in the direction along the optical axis of the observation system 12 pg. 7 para. 2
including alignment light source 17a through objective lens 12a fig. 2 which is coarse alignment defined
as alignment to the eyepiece lens to see the fixation target paragraph [0031] of the current application)
to observe the fixation target (alignment light source 17a fig. 2);
wherein the retinal image is captured (the objective examination includes objective
measurement for measuring values related to the subject's eye and photography for obtaining an image
of the subject's eye including fund us photography pg. 2 para. 2, the fund us includes the retina and
retinal image sensor is taught above by Ichikawa) after achieving the coarse alignment (the alignment
system 16 has a function of performing alignment in the direction along the optical axis of the
observation system 12 pg. 7 para. 2 including alignment light source 17a through objective lens 12a fig.
2 which is coarse alignment defined as alignment to the eyepiece lens to see the fixation target
paragraph [0031] of the current application) of the eye (eye E fig. 2) to the eyepiece lens (objective lens
12a fig. 2) with the visual cue (a bright spot image is projected onto the cornea C by the alignment
system 16 pg. 8 para. 2 of translation) and after the fine alignment (the alignment system 17 is used for
alignment in the vertical and horizontal directions pg. 8 para. 2 and is achieved when the bright spot
from alignment light 17a is in focus pg. 9 para. 2 the light from alignment light source 17a is directed to
the eye E along the same optical path as image sensor 12g by half mirror 12C which aligns the eye E in
the eye box of the image sensor 12g fig. 2, fine alignment is defined as being achieved when the eye is in
the eye box of the imaging system paragraph [0037] of current application) of the eye (eye E fig. 2) to
the eyepiece lens (objective lens 12a fig. 2) with the fixation target (alignment light source 17a fig. 2).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to use the coarse and fine alignment as taught by Umeji in the retinal camera of
Ichikawa. The alignment system allows for manual and automatic alignment (pg. 9 para. 3-4).
Claims 14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ichikawa (JP 2010035729 A) in view of Brown et al. (US 20150216408 A1), Frey (US 5442412 A) and Umeji (WO 2015102092 A1) as applied to claim 13 above and in further view of Sakai (US 10149615 B2).
Regarding claim 14, the combination of Ichikawa, Brown, Frey, Umeji , Brown and Frey discloses all the limitations of claim 13.
Ichikawa does not disclose, further comprising:
dynamically altering one or more of a brightness of the visual cue, a shape- pattern of the visual
cue, a temporal-pattern of the visual cue, or colors of the visual cue to guide the eye into the coarse
alignment.
However Sakai discloses in at least figures 6-7, the method further comprising:
dynamically altering (the control circuit 27 controls the MEMS mirror 23 to change the scanning locus at the time of alignment col. 10 lines 55-59) one or more of, a brightness (the brightness in uneven
on one side of the fund us until alignment is achieved col. 9 lines 52-67) of the visual cue (alignment
indicator col. 10 line 17), and a shape-pattern (the circular locus displayed on the screen is not fully
shown until alignment is achieved col. 10 lines 27-39) of the visual cue (alignment indicator col.10 line
17).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to use the visual guidance indicator, to alter the brightness and shape of the visual
cue, as taught by Sakai as part of the housing peripherally about the eyepiece of Ichikawa. When the
apparatus body is misaligned the light spots are missing in one corner of the eye which lets the examiner
know which direction to move the body (col. 11 lines 27-34).
Regarding claim 16, the combination of Ichikawa, Umeji, Brown and Frey discloses all the limitations of claim 13 and Ichikawa further discloses, further comprising:
tracking a pupil or an iris (pupil position is detected by imaging element 65 paragraph [0060]) of
the eye (eye E fig. 2) with an alignment tracking camera (imaging element 65 serves as an imaging
means for detecting alignment paragraph [0023]);
determining a relative position (alignment reference position paragraph [0056]) of the eye (eye
E fig. 2) to the eyepiece lens (objective lens 25 fig. 2) based upon the tracking (the tracking control for
the eye is based on the alignment reference position paragraph [0056]).
Ichikawa does not disclose, dynamically altering the visual cue based on the relative position to
provide feedback guidance to the eye for achieving the coarse alignment,
wherein the feedback guidance includes cues visually instructing a user to move the eye relative
to the eyepiece lens in a lateral direction or an eye relief direction.
However Sakai discloses in at least figures 10-12, dynamically altering (when misaligned
illumination light fluxes from the light source 20 col. 9 lines 30-33) the visual cue (illumination light col. 9
line 47) based on the tracking (when alignment is not achieved the brightness is uneven on one side of
the fundus col.9 lines 44-67) to provide feedback guidance (the brightness col.9 lines 44-67) to the eye
(subject eye Ecol. 9 fig. 10) for achieving the coarse alignment (when alignment is achieved there is no
unevenness in brightness col.9 lines 44-67),
wherein the feedback guidance (the brightness col.9 lines 44-67) includes cues visually
instructing a user (illumination light col. 9 line 47) to move the eye (eye Ecol. 9 fig. 10) relative to (as the
eye becomes aligned with the eyepiece the brightness displayed becomes even lines 44-67) the
eyepiece lens (objective lens 25 fig. 7) in a lateral direction (direction perpendicular to the optical axis
col. 9 line 63) or an eye relief direction (optical axis direction col. 9 line 63).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to alter the visual cue as taught by Sakai in the alignment tracking of Ichikawa. When
the apparatus body is misaligned the light spots are missing in one corner of the eye which lets the
examiner know which direction to move the body (col.11 lines 27-34).
Regarding claim 17, the combination of Ichikawa, Umeji, Brown, Frey and Sakai discloses all the
limitations of claim 16 and Ichikawa further discloses, further comprising:
illuminating (alignment index projection optical system 50 projects a light beam on the eye that
is detected by image sensor 65 paragraph [0023]) the eye (eye E fig. 2) with the visual guidance indicator
(alignment index projection optical system 50 fig. 1);
and acquiring an anterior segment image (optical system 60 images the anterior of the eye
paragraph [0023]) of the eye (eye E fig. 2) with at least one of (optical system 60 images the anterior of
the eye with imaging element 65 paragraph [0023]) the alignment tracking camera (imaging element 65
serves as an imaging means for detecting alignment paragraph [0023]) or the retinal image sensor while
using the visual guidance indicator (alignment index projection optical system 50 fig. 1) to provide
illumination (alignment index projection optical system 50 projects a light beam on the eye that is
detected by image sensor 65 paragraph [0023]) for the anterior segment image (optical system 60
images the anterior of the eye paragraph [0023]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ichikawa (JP 2010035729
A) in view of Brown et al. (US 20150216408 A1), Frey (US 5442412 A) and Umeji (WO 2015102092 Al) as applied to claim 13 above and in further view of Mizuochi (US 20060126017 Al).
Regarding claim 15, the combination of Ichikawa, Umeji, Brown and Frey discloses all the limitations of claim 13.
Ichikawa does not explicitly disclose dimming or disabling the visual cue after the eye archives
coarse alignment and prior to capturing the retinal image of the eye.
However Mizuochi discloses in at least figure 1, dimming or disabling (the red-light LED of the
alignment index light source 60 is dimmed paragraph [0040]) the visual cue (red-light LED of the
alignment index light source 60 fig. 1) after the eye (eye E fig. 1) archives coarse alignment (the
alignment index light source is dimmed after coarse alignment and the focus light source 70 emits index
light source emits infrared light [0040]) and prior to capturing (during the observation the alignment
index light source is dimmed paragraph [0040]) the retinal image (the observation is recorded on film 44
paragraph [0040] of the eye (eye E fig. 1).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to dim the visual cue as taught by Mizuochi in the alignment indicator of Ichikawa.
The dimming of the visual cue allows of infrared light to be emitted paragraph [0040]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ichikawa (JP
2010035729 A) in view of Brown et al. (US 20150216408 A1), Frey (US 5442412 A), Umeji (WO 2015102092 Al) and Sakai (US 10149615 B2) as applied to claim 16 above and in further view of Niece (US 20160192837 Al).
Regarding claim 18, the combination of Ichikawa, Umeji, Brown, Frey, and Sakai discloses all the
limitations of claim 16 and Ichikawa further discloses, wherein the controller (control unit 80 fig. 1)
includes further logic (imaging element 65 is connected to the control unit paragraph [0026]) that when
executed by the controller (control unit 80 fig. 1) causes the retinal camera system (fundus camera
paragraph [0010]) to perform additional operations (the control unit detects the misalignment of the
imaging unit 3 with respect to the eye based on the light reception output from imaging element 65
paragraph [0026]) including:
illuminating (alignment index projection optical system 50 projects a light beam on the eye that
is detected by image sensor 65 paragraph [0023]) the eye (eye E fig. 2) with the visual guidance indicator
(alignment index projection optical system 50 fig. 1).
Ichikawa does not explicitly disclose, varying an intensity of the illuminating and measuring
pupillary reactions to the varying of the intensity with at least one of the alignment tracking camera or
the retinal image sensor to perform pupillometry testing of a pupil of the eye.
However Neice discloses in at least figures 1-6, varying an intensity of the illuminating (radiation
source at fluctuating intensities paragraph [0049]);
and measuring pupillary reactions (pupil reflex response paragraph [0049]) to the varying of the
intensity (radiation source at fluctuating intensities paragraph [0049]) with at least one of the alignment tracking camera or the retinal image sensor (digital camera paragraph [0043] retinal image sensor
taught above by Ichikawa) to perform pupillometry testing (pupil reflex response paragraph [0049]) of a
pupil of the eye (pupil paragraph [0049]).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to add the functions of varying the intensity of the illumination to measure
pupillometry as taught by Neice to the controller of Ichikawa to be executed using the image sensors.
Claims 19-20 are rejected as being unpatentable over Ichikawa (JP 2010035729 A) in view of Brown et al. (US 20150216408 A1), Frey (US 5442412 A), Umeji (WO 2015102092 Al) and Sakai (US 10149615 B2) as applied to claims 16 above and in further view of Shalon et al. (US 5585873 A).
Regarding claim 19, the combination of Ichikawa, Umeji, Brown, Frey, and Sakai discloses all the
limitations of claim 16.
Ichikawa does not disclose, the method further comprising:
sequentially activating different angular positions of the visual guidance indicator about the
eyepiece lens to illuminate the eye from the different angular positions;
observing reflections off a cornea of the eye with at least one of the alignment tracking camera
or the retinal image sensor;
and determining a surface curvature of the cornea based upon the reflections.
However Shalon discloses in at least figures 1-2, wherein the controller (computer 22 fig. 1)
includes further logic (computer 22 can be used to program the keratometer 10 col. 6 lines 61-62) that
when executed by the controller (computer 22 fig. 1) causes the retinal camera system to perform
additional operations including:
sequentially activating (alignment is facilitated by projecting a pattern of collimated light
sources on to the eye col. 8 lines 15-17) different angular positions (the angles of the beam are known
with respect to the optical axis col. 8 lines 33-34) of the visual guidance indicator (fixation light
col. 8 line 24) about the eyepiece lens (eyepiece 34 fig. 1) to illuminate (light sources illuminate the eye
col. 8 line 28-29) the eye (patients eye col. 8 line 27) from the different angular positions (a light is used
as a fixation target at know angles onto the patient's eye col. 8 lines 24-37);
observing reflections off a cornea of the eye (reflected from the cornea col. 8 line 25) with at
least one of the alignment tracking camera (alignment is facilitated by projecting a pattern of collimated
light sources on to the eye col. 8 lines 15-17 and reflected to camera which includes what is called a CCD
imager col. 8 lines 42-43) or the retinal image sensor;
and determining a surface curvature of the cornea (radius of curvature of the cornea col. 8 lines
34-37) based upon the reflections (images reflected from the cornea can be used to derive the radii of
curvature and major and minor axis angles of the cornea col.8 lines 33-37).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to add the function of observing reflections of the cornea to obtain the curvature as
taught by Shalon to the image sensors and controller of Ichikawa. Observing the cornea will allow the
examiner to such things as keratoconus, dystrophies, and stigmatism, corneal problems, and abnormal
curvature (col. 1 lines 27-31).
Regarding claim 20, the combination of Ichikawa, Brown, Frey, Umeji and Sakai discloses all the limitations of claim 16.
Ichikawa does not disclose, activating the visual guidance indicator to illuminate the eye with a
reference pattern;
capturing a reflection of the reference pattern off of a cornea of the eye with at least one of the
alignment tracking camera or the retinal image sensor and analyzing the reflection to determine a
surface curvature of the cornea.
However Shalon discloses in at least figures 1-2, wherein the controller (computer 22 fig. 1)
includes further logic (computer 22 can be used to program the keratometer 10 col. 6 lines 61-62) that
when executed by the controller (computer 22 fig. 1) causes the retinal camera system to perform
additional operations including:
activating the visual guidance indicator (fixation light col. 8 line 24) illuminate (light sources
illuminate the eye col. 8 line 28-29) the eye (patients eye col. 8 line 27) with a reference pattern (the
angles of the light beams are known and are used as reference to measure the radii of curvature of the
cornea col. 8 lines 33-37);
capturing a reflection (reflected from the cornea col. 8 line 25) of the reference pattern (the
angles of the light beams are known and are used as reference to measure the radii of curvature of the
cornea col. 8 lines 33-37) off of a cornea of the eye (reflected from the cornea col. 8 line 25) with at least
one of the alignment tracking camera (alignment is facilitated by projecting a pattern of collimated light
sources on to the eye col. 8 lines 15-17 and reflected to camera which includes what is called a CCD
imager col. 8 lines 42-43) or the retinal image sensor;
and analyzing the reflection to determine a surface curvature of the cornea (images reflected
from the cornea can be used to derive the radii of curvature and major and minor axis angles of the
cornea (col.8 lines 33-37 by camera means 78 col. 9 lines 39-51).
Therefore it would be obvious for one skilled in the art before the effective filling date of the
claimed invention to add the function of observing reflections of the cornea using a reference pattern to
obtain the curvature as taught by Shalon to the image sensors and controller of Ichikawa. Observing the
cornea will allow the examiner to such things as keratoconus, dystrophies, and stigmatism, corneal
problems, and abnormal curvature (col. 1 lines 27-31).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ichikawa (JP 2010035729 A) in view of Brown et al. (US 20150216408 A1) and Frey (US 5442412 A) as applied to claim 1 and in further view of Takahashi (US 10289907 B2).
Regarding claim 22, the combination of Ichikawa, Brown and Frey, discloses all the limitations of claim 1.
Ichikawa does not disclose, wherein the visual guidance indicator is visible to the eye when the eye is outside an eyebox of the retinal camera system and before the eye can view a fixation target displayed through the eyepiece lens.
However Frey further discloses, wherein the visual guidance indicator (ring of light 40 fig. 4) is visible to (the patient's eye will perceive the particular directional light dot at infinity col. 7 lines 19-20) the eye (eye 10 fig. 4) when the eye (eye 10 fig. 4) is outside an eyebox (eye movement along a direction indicated by arrow 50 that is exactly between dots 350 and 351 col. 7 lines 9-14 is away from dot 30 shown in the center of the lens 400 fig. 4 which is the desired position of the eye to move toward col. 7 lines 9-14, described in the current application paragraph [0004] as “the eyebox for a retinal camera is a three dimensional region in space typically defined relative to an eyepiece of the retinal camera and within which the center of a pupil or cornea of the eye should reside to acquire an acceptable image of the retina”) of the retinal camera system (lens 400 fig. 4 retinal camera taught above by Ichikawa).
Therefore it would be obvious for one skilled in the art before the effective filling date of the claimed invention to use visible feedback for alignment as taught by Frey in the fundus camera of Ichikawa. To increase the precision of the directional feedback, additional directional LED's can be added (col. 7 lines 1-7).
Additionally Takahashi discloses in the least figure 2, before the eye (eye to be inspected 200 fig. 2) can view (the fixation lamp has is configured to emit visible light col. 4 lines 44-46) a fixation target (fixation lamp 211 fig. 2) displayed through (the fixation lamp 211 is display through the objective lens 201 fig. 2) the eyepiece lens (objective lens 201 fig. 2).
Therefore it would be obvious for one skilled in the art before the effective filling date of the claimed invention to use visible fixation lamp as taught by Takahashi in the fundus camera of Ichikawa. By blinking the fixation lamp 211 it is possible to urge fixation of a person to be inspected col. 5 lines 59-64).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ryan (US 20160022134 A1) discloses a dynamic OCT device with visible alignment targets around an imaging device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW R WRIGHT whose telephone number is (703)756-5822. The examiner can normally be reached Mon-Thurs 7:30-5 Friday 8-12.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pinping Sun can be reached at 1-571-270-1284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREW R WRIGHT/Examiner, Art Unit 2872
/PINPING SUN/Supervisory Patent Examiner, Art Unit 2872
Prosecution Insights