DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This office action is in response to a reply filed 6/5/2026.
Notice of Pre-AIA or AIA Status
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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/21/2024 complies with the provisions of 37 CFR 1.97. Accordingly, the examiner considered the information disclosure statement.
Election/Restrictions
Applicant's election of Group II, Claims 19 and 23-29, without traverse in the reply filed on 6/5/2026 is acknowledged. Claims 1-5 and 7-11 are withdrawn as being drawn to a non-elected group and claims 19 and 23-29 are examined herein.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 19 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Imamura (US20140340638).
Regarding claim 19, Imamura teaches a method (Imamura, figs. 1-7B, paragraph [0009] “a method therefor by enabling to readily compare and observe a plurality of moving images captured in a plurality of imaging areas of a fundus.”) comprising:
receiving, by a processor (fig. 1, paragraph [0037] “an image processing unit 140”), a set of detection path signals (paragraph [0011] “obtaining a plurality of moving images which are obtained by capturing a plurality of imaging areas of a fundus and each of which is associated with pulse data based on a biomedical signal obtained in capturing the moving image”) from an optical array (paragraph [0033] “CCD is connected to a lens array”), the detection path signals corresponding to a plurality of scans of a subject's retina (in paragraphs [0002]-[0003]: “a scanning laser ophthalmoscope, SLO, serving as an ophthalmic apparatus based on the principle of a confocal laser microscope performs raster scan on a fundus with a laser beam serving as measurement light”) taken over a time interval (see paragraph [0058] “<Step S640> The frame interval adjustment unit 1433 adds or deletes frames so that at least the numbers of frames of the respective SLO moving images in a section to be synchronously played back are almost equal to each other. In this embodiment, the following processing is executed so that the numbers of frames in each cycle indicated by the pulse data are equal to each other. The frame interval adjustment unit 1433 obtains a cardiac cycle Hi in a frame number sequence I which has been selected from each SLO moving image Di in step S640. The cardiac cycle Hi may generally change depending on the SLO moving image Di, and also change within the same SLO moving image as shown in FIG. 7B. In this embodiment, a cardiac cycle Hr. (1.0 [sec] in FIG. 7B) closest to a normal cycle is set as a reference cycle. If the difference between a given cycle and the reference cycle Hr. is equal to or larger than a tolerance T6, the cycle is considered as a different one, and then the process advances to step S650. If the difference between a given cycle and the reference cycle Hr. is smaller than the tolerance T6, the synchronization processing ends, and the process advances to step S440”; further, in paragraphs [0002]-[0003]: “a scanning laser ophthalmoscope, SLO, serving as an ophthalmic apparatus based on the principle of a confocal laser microscope performs raster scan on a fundus with a laser beam serving as measurement light, and quickly obtains a high-resolution planar image based on the light intensity of a return beam. Such an apparatus for capturing a planar image will be referred to as an SLO apparatus hereinafter. The planer image will be referred to as an SLO image hereinafter. [0003] it has become possible to obtain an SLO image of a retina with an improved lateral resolution by increasing the beam size of measurement light in an SLO apparatus. As the beam size of measurement light increases, however, the resolution and SN ratio of a planar image decrease due to the aberration of an eye to be examined in obtaining an SLO image of a retina”; although Imamura describes the imaging target as a “fundus” a person of ordinary skill in the art would have understood that SLO fundus imaging is primarily directed to imaging the retina, which constitutes the major anatomical structure of the ocular fundus and is the principal source of the returned optical signal in SLO systems. Therefore, it would have been obvious to interpret the plurality of fundus scans in Imamura as corresponding to a plurality of scans of a subject’s retina over a time interval, because such imaging systems inherently acquire retinal information when performing fundus imaging.).
processing, by the processor, the set of detection path signals to generate a plurality of images of the subject's retina (paragraph [0052] “The synchronization processing executed in step S430 will be described in detail with reference to FIGS. 6, 7A, and 7B. The synchronization processing selects display target sections from the plurality of respective SLO moving images so as to limit the number of exceptional frames to be played back (set the number of exceptional frames to be played back to be equal to or smaller than a predetermined number (including 0)), and synchronously displays the selected sections”);
determining, by the processor, a signal to noise ratio for each retinal image of the plurality of images of the subject's retina (paragraph [0045] “The unit 142 detects, from each SLO moving image Di, an exceptional frame, that is, a frame where the luminance is extremely low due to blinking, a frame where image distortion has occurred due to involuntary eye movement during fixation, or a frame where an SN ratio (signal to noise ratio) is low due to an aberration correction failure”);
determining, by the processor, whether the signal to noise ratio for each retinal image is below a threshold value (paragraph [0045] “ if the SN ratio is equal to or smaller than a threshold T4, it is considered that an aberration correction failure has occurred, thereby determining the frame as an exceptional frame”) and, if so, removing any set retinal image with a signal to noise ratio below the threshold from the plurality of images of the subject's retina, thereby generating an edited set of images of the subject's retina (paragraph [0046] “<Step S430> The synchronization unit 143 executes processing for synchronizing the playback timings of the respective moving images based on the pulse data in playback/display processing of the plurality of SLO moving images in step S440 (to be described later). The synchronization unit 143 obtains the pulse data Pi of each SLO moving image Di from the pulse data obtaining unit 120, and detects the local maximum values of the pulse data Pi to calculate a cardiac cycle. The synchronization unit 143 then obtains an exceptional frame number sequence detected in step S420 for each SLO moving image Di. The synchronization unit 143 selects a frame to be displayed so as to exclude the exceptional frames.”).
Regarding claim 23, Imamura discloses the invention as described in Claim 19 and Peng further teaches wherein further comprising:
receiving, by the processor, a preferred luminance level range for retinal images (paragraph [0045] “In this embodiment, if the average luminance value Aij is equal to or smaller than a threshold T2, the frame j of the SLO moving image Di is considered as a frame where a luminance error has occurred due to blinking, thereby determining it as an exceptional frame.”);
but Imamura of first Embodiment does not explicitly disclose wherein determining, by the processor, whether a luminance level for each retinal image of the edited set of images of the subject's retina falls within the preferred luminance level range and, if not, adjusting the luminance level for each of the retinal images included in the edited set of images of the subject's retina that does not fall within the preferred luminance level range for retinal images.
However, Imamura of third embodiment teaches determining, by the processor, whether a luminance level for each retinal image of the edited set of images of the subject's retina falls within the preferred luminance level range and, if not, adjusting the luminance level for each of the retinal images included in the edited set of images of the subject's retina that does not fall within the preferred luminance level range for retinal images (as described in paragraph [0096] “In the third embodiment, in addition to the arrangement of the second embodiment, a display unit 144 adjusts the luminance between SLO moving images Di with different imaging positions and/or between a wide field of view image W and each SLO moving image Di. This operation also adjusts not only the positional relationship and display timing but also the luminance characteristics between the SLO moving images Di with different imaging positions or between the wide field of view image W and each SLO moving image Di. The observer can, therefore, more readily compare and observe blood cell kinetics and a change in blood vessel shape”; therefore, it would have been obvious to interpret wherein determining, by the processor, whether a luminance level for each retinal image of the edited set of images of the subject's retina falls within the preferred luminance level range and, if not, adjusting the luminance level for each of the retinal images included in the edited set of images of the subject's retina that does not fall within the preferred luminance level range for retinal images.).
Thus, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Imamura of first embodiment to have the specific function as taught by Imamura of third embodiment for the purpose of more readily compare and observe blood cell kinetics and a change in blood vessel shape (Imamura, paragraph [0096]).
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Imamura (US20140340638), and further in view of Yu et al. (CN105787927, English translation attached).
Regarding claim 24, Imamura discloses the invention as described in Claim 19 and Imamura further teaches wherein further comprising:
analyzing, by the processor, each retinal image included in the edited set of images of the subject's retina to determine differences therebetween (see paragraph [0030] “a plurality of SLO moving images Di (i=1, 2, . . . , n0) at different imaging positions”; “This processing enables to exert, on the SLO moving images Di, an almost equal influence of a variation in image characteristics due to a vital reaction such as pulsation or blinking”; “it is possible to compare and observe blood cell kinetics and a change in blood vessel shape between the SLO moving images Di with different imaging positions and different imaging times while understanding the relationship with an anatomical site and the progress of a disease outside the imaging areas of the SLO moving images Di”);
but Imamura does not explicitly disclose wherein providing, by the processor, an indication of a determined difference to an operator.
However, Yu teaches the analogous scanning fundus image (Yu, abstract, the method includes a fundus image), and further teaches wherein providing, by the processor, an indication of a determined difference to an operator (Yu, abstract, According to the method provided by the invention, fundus images obtained under different acquisition conditions can be processed, further diagnosis of an ophthalmological doctor is further facilitated).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Imamura to have the specific function as taught by Yu for the purpose of diagnosis of an ophthalmological doctor is further facilitated (Yu, abstract).
Regarding claim 25, Imamura discloses the invention as described in Claim 19 and Imamura further teaches wherein further comprising:
analyzing, by the processor, each retinal image included in the edited set of images of the subject's retina to determine a characteristic thereof (paragraph [0030] “This processing enables to exert, on the SLO moving images Di, an almost equal influence of a variation in image characteristics due to a vital reaction such as pulsation or blinking”); and
comparing, by the processor, a determined characteristic of at least two retinal images to one another (paragraph [0030] “it is possible to compare and observe blood cell kinetics and a change in blood vessel shape between the SLO moving images Di with different imaging positions and different imaging times while understanding the relationship with an anatomical site and the progress of a disease outside the imaging areas of the SLO moving images Di”);
Imamura does not explicitly disclose wherein providing, by the processor, an indication of the comparison to an operator.
However, Yu teaches the analogous scanning the image (Yu, abstract, the method includes a fundus image), and further teaches wherein providing, by the processor, an indication of the comparison to an operator (Yu, abstract, according to the method provided by the invention, fundus images obtained under different acquisition conditions can be processed, further diagnosis of an ophthalmological doctor is further facilitated).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Imamura to have the specific function as taught by Yu for the purpose of diagnosis of an ophthalmological doctor is further facilitated (Yu, abstract).
Regarding claim 26, combination Imamura-Yu discloses the invention as described in Claim 25 and Imamura further teaches wherein the determined characteristic is a position of a feature shown in the at least two retinal images (paragraph [0030] “a plurality of SLO moving images Di (i=1, 2, . . . , n0) at different imaging positions”; “This processing enables to exert, on the SLO moving images Di, an almost equal influence of a variation in image characteristics due to a vital reaction such as pulsation or blinking”; “it is possible to compare and observe blood cell kinetics and a change in blood vessel shape between the SLO moving images Di with different imaging positions and different imaging times while understanding the relationship with an anatomical site and the progress of a disease outside the imaging areas of the SLO moving images Di”), the method further comprising:
determining, by the processor, a velocity of retinal motion using the position of the feature shown in the at least two retinal images and a time interval between the capturing of the detection path data used to generate the at least two retinal images (see Imamura, paragraph [0005] “In the above comparison and observation operation, to fully understand the progress of a disease, it is important to identify the positional relationship with an anatomical site/lesion or a normal site outside the imaging area of a moving image. A wide field of view image is, therefore, additionally obtained for use in the comparison and observation operation. Note that the blood vessel diameter or blood flow velocity may change due to a normal vital reaction such as a cardiac cycle, motion, or a change in body temperature (in addition to a change caused by a disease). To compare images captured at different imaging positions, therefore, the images need to be captured under an almost equal influence of such a vital reaction. That is, it is necessary to obtain biomedical signal data (pulse data) such as a pulse wave in capturing images, and to respectively compare blood vessel diameters and blood flow velocities with each other at the cardiac end-diastole (when the blood vessel diameter is largest, and the blood flow velocity is lowest). To compare a plurality of moving images with different imaging position”; thus, Imamura teaches wherein a velocity of retinal motion using the position of the feature shown in the at least two retinal images and a time interval between the capturing of the detection path data used to generate the at least two retinal images).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Imamura (US20140340638) in view of Yu et al. (CN105787927, English translation attached), and further in view of Sheehy et al. (WO2019210217A1).
Regarding claim 27, combination Imamura-Yu discloses the invention as described in Claim 25, but Imamura does not explicitly disclose wherein the determined characteristic is a direction of retinal motion, a magnitude of retinal motion, a speed of retinal motion, a magnitude of drift, and a velocity of drift.
However, Sheehy teaches the analogous fixational eye movement may be analyzed (Sheehy, abstract, fixational eye movement may be analyzed to determine one or more characteristics thereof), and further teaches wherein the determined characteristic is a direction of retinal motion (paragraph [0002] “The present invention relates to a method for detecting, prognosticating, and monitoring a neurological disorder through the use of fixational eye motion measurements”; vertical direction), a magnitude of retinal motion (paragraph [0035] “magnitude in the vertical direction”), a speed of retinal motion (paragraph [0037] “the raw and average speed of eye motion”), a magnitude of drift, and a velocity of drift (paragraph [0055] “a raw drift amplitude, an average drift amplitude, a peak drift amplitude, a drift duration, an acceleration in the vertical direction, a velocity in the vertical direction, a magnitude in the vertical direction, and/or a disconjugacy of any of the aforementioned motions between eyes.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Imamura to have the specific function as taught by Sheehy for the purpose to be used to diagnose, monitor, and prognosticate neurological disorders without administration of traditionally used neurological function tests or analysis of biological samples by which the diagnostic indicators are typically determined (Sheehy, abstract).
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Imamura (US20140340638), and further in view of Hadoux et al. (US20230255470).
Regarding claim 28, Imamura discloses the invention as described in Claim 19, Imamura does not explicitly disclose wherein determining the signal to noise ratio includes performing a frequency spectrum analysis on each retinal image.
However, Hadoux teaches the analogous detection path signals to generate a plurality of images of the subject's retina (paragraph [0008] “Multispectral/hyperspectral fundus cameras: Multiple solutions for multispectral and hyperspectral imaging have been proposed. Pixel scanning is a method that records a single spectral pixel and moves the sampling in both spatial dimensions. An alternative to scanning in two dimensions is using a push broom acquisition. In push broom imaging, a narrow strip of the fundus is imaged and the spectral component of the reflected light is dispersed on the sensor in a direction that is perpendicular to the scanning axis. Whilst this approach is widely used in remote sensing, as the movement of a satellite serves as the scanning direction, it is more difficult to apply to fundus imaging due to rapid movements (saccades) of the eye, which require complex post-processing alignments”), and further teaches wherein determining the signal to noise ratio includes performing a frequency spectrum analysis on each retinal image (see Hadoux, fig. 5, paragraph [0031] “In some embodiments, the power of the one or more light sources is controlled to achieve a threshold signal-to-noise ratio for the tissue being imaged”; paragraph [0081] “FIG. 5 shows graphs of an illumination spectrum, sensor spectral sensitivity and a spectrum of a target sample as a function of wavelength across a spectral range of 450 nm to 700 nm”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Imamura to have the specific function as taught by Hadoux for the purpose of achieving high quality images at multiple wavebands within a short time frame (Hadoux, paragraph [0010]).
Regarding claim 29, combination Imamura-Hadoux discloses the invention as described in Claim 28 and Hadoux further teaches wherein determining the signal to noise ratio includes determining a relationship between frequency and intensity for each retinal image of the plurality of images of the subject's retina (see fig. 5, paragraph [0031] “In some embodiments, the power of the one or more light sources is controlled to achieve a threshold signal-to-noise ratio for the tissue being imaged”; paragraph [0081] “FIG. 5 shows graphs of an illumination spectrum, sensor spectral sensitivity and a spectrum of a target sample as a function of wavelength across a spectral range of 450 nm to 700 nm”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Imamura to have the specific function as taught by Hadoux for the purpose of achieving high quality images at multiple wavebands within a short time frame (Hadoux, paragraph [0010]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KUEI-JEN LEE EDENFIELD whose telephone number is (571)272-3005. The examiner can normally be reached Mon. -Thurs 8:00 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pinping Sun can be reached on (571) 270-1284. The fax phone number for the organization where this application or proceeding is assigned is 571-273- 8300.
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/KUEI-JEN L EDENFIELD/
Examiner, Art Unit 2872
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