DETAILED ACTION
This Office Action for U.S. Patent Application 17/905,189 is responsive to communications filed on 6/27/25, in reply to the Non-Final Rejection of 3/28/25. Currently, claims 1, 3, and 5-20 are pending.
Response to Amendment
Applicant’s amendments to claims 1, 3, 5, 6, and 8-20 are acknowledged. The cancelation of claims 2 and 4 is also acknowledged.
The objection to claim 2 is now moot as claim 2 is canceled by Applicant.
In view of Applicant’s amendments to claims 1, 12, 13, 15, 17, and 19, the interpretation of the claims under 35 U.S.C. 112(f) is withdrawn.
Response to Arguments
Applicant's arguments filed 6/27/25 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues on pages 10-11 of the Response that Takahashi does not teach “control a second imaging element to capture a second plurality of images of each of the plurality of regions of the target at a magnification higher than a magnification of the first imaging element”, as amended.
However, Takahashi teaches a partial image imaging unit 12 of digital microscope 1 which images a part of the observation target region of a prepared specimen placed on the stage with a high magnification and a high resolution (Figs. 1-2; col. 6, lines 14-32). Although Applicant argues that Takahashi only recites that a part of the observation target region is imaged (Figs. 1-2; col. 6, lines 14-32) and therefore does not teach “a second plurality of images of each of the plurality of regions”, Takahashi also states that the partial images (i.e., “a plurality of images”) are imaged by the partial image imaging unit 12 of the digital microscope 1 based on the imaging order (Step 6) and that the partial images imaged by the partial image imaging unit 12 are successively output to the information processing device 2 (Fig. 1-2, 5, and 6; col. 6, lines 23-29 and col. 11, lines 9-20). The entire imaging unit 11 (i.e., “first imaging element”) of Takahashi images the entire observation target region with a low magnification while the partial image imaging unit 12 (i.e., “second imaging element”) images a part of the observation target region with a high magnification (Fig. 1-2; col. 6, lines 19-29).
Therefore, Takahashi teaches all of the limitations of claim 1 as discussed above. In addition, please refer to the below-stated rejection of claim 1.
Regarding claims 3 and 5-20, please see the above-stated discussed for claim 1. In addition, please refer to the below-stated rejection of the claims.
Claim Rejections - 35 USC § 102
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 following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 12-14, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takahashi et al. (U.S. Patent No. 11,307,399; WO2013/179723 cited in IDS filed 8/29/22).
In regard to claim 1, Takahashi 1 teaches a microscope device (i.e., 1: Digital microscope in Fig. 1; Fig. 2) comprising:
circuitry (i.e., Fig. 1) configured to:
control a first imaging element (i.e., entire image imaging unit 11 of digital microscope 1) (Figs. 1-2; col. 6, lines 14-32) to capture a first plurality of images of a target including a living tissue and acquire first image data (i.e., the entire imaging unit 11 images the entire observation target region of a prepared specimen placed on the stage with a low magnification and with a low resolution) (Figs. 1-2; col. 6, lines 19-23);
divide an imaged region of the target into a plurality of regions (i.e., imaging order in Fig. 10C) (Fig. 10C; col. 10, line 63-col. 11, line 8) based in the captured first plurality of images (i.e., imaging control unit 24 controls the drive of the digital microscope 1 based on the imaging order; partial images are imaged by the partial image imaging unit 12 of the digital microscope 1 based on the imaging order (Step S6)) (Fig. 5, 10C; col. 9-16);
control a second imaging element (i.e., partial image imaging unit 12 of digital microscope 1) (Figs. 1-2; col. 6, lines 14-32) to capture a second plurality of images of each of the plurality of regions of the target (i.e., partial image imaging unit 12 images a part of the observation target region of a prepared specimen placed on the stage with a high magnification and a high resolution; the partial images are imaged by the partial image imaging unit 12 of the digital microscope 1 based on the imaging order (Step 6); the partial images imaged by the partial image imaging unit 12 are successively output to the information processing device 2) (Fig. 1-2, 5, and 6; col. 6, lines 23-29 and col. 11, lines 9-20) at a magnification higher (i.e., partial image imaging unit 12 images a part of the observation target region of a prepared specimen placed on the stage with a high magnification and a high resolution) (Fig. 1-2; col. 6, lines 23-29) than a magnification of the first imaging element and acquire second image data (i.e., the entire imaging unit 11 images the entire observation target region of a prepared specimen placed on the stage with a low magnification and with a low resolution) (Figs. 1-2; col. 6, lines 19-23);
determine a feature related to the target based on the acquired first image data (i.e., the entire image imaged in Step S1 is output from an interface 14 of the digital microscope 1, and then input into the image processing unit 23 through an interface 26 of the information processing device 2; image analysis unit 232 of the image processing unit 23…judges whether or not the observation target is present in each region (i.e., “a feature”)) (Fig. 5; col. 9, lines 53-67);
control the second imaging element based on a result of the determination (i.e., imaging control unit 24 controls the drive when imaging partial images by the digital microscope 1 based on the judgment results of the image analysis unit 232; the imaging control unit 24 controls the drive of the digital microscope 1) (Figs. 1, 2, 4, and 5 ; col. 8, lines 1-13).
In regard to claim 12, Takahashi teaches all of the limitations of claim 1 as discussed above. In addition, Takahashi teaches further comprising: wherein the circuitry is further configured to execute one of (i.e., imaging control unit 24) (Figs. 1, 2, 4, and 5; col. 8, lines 1-13) an imaging control operation of the target by the second imaging element or an image processing operation of an image obtained by the second imaging element (i.e., imaging control unit 24 controls the drive when imaging partial images by the digital microscope 1 based on the judgment results of the image analysis unit 232; the imaging control unit 24 controls the drive of the digital microscope 1) (Figs. 1, 2, 4, and 5; col. 8, lines 1-13).
In regard to claim 13, Takahashi teaches all of the limitations of claims 1 and 12 as discussed above. In addition, Takahashi teaches wherein the circuitry is further configured control an imaging order based on a feature related to a region of the target (i.e., imaging order generation unit which creates imaging order of the partial images based on the judgment results of the image analysis unit; the imaging control unit may control drive of the microscope based on the imaging order created by the imaging order generating unit) (col. 3, lines 45-49).
In regard to claim 14, Takahashi teaches all of the limitations of claims 1 and 12-13 as discussed above. In addition, Takahashi teaches wherein
the circuitry is further configured to:
execute the imaging control operation such that a joint of the plurality of regions does not overlap a region of interest in the target (i.e., imaging order generation unit which creates imaging order of the partial images based on the judgment results of the image analysis unit; the imaging control unit may control drive of the microscope based on the imaging order created by the imaging order generating unit) (Figs. 7 and 10; col. 3, lines 45-49 and col. 10, line 55-col. 11, line 8), or
execute the imaging control operation such that the region of interest in the target is imaged a plurality of times.
In regard to claims 19 and 20, the claims recite analogous limitations to claim 1 above, and are therefore rejected on the same premise.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Takahashi et al. (U.S. Patent No. 11,307,399; WO2013/179723 cited in IDS filed 8/29/22) in view of Kaihatsu et al. (U.S. Patent No. 10,708,483; WO2017/022462 cited in the IDS filed 8/29/22).
In regard to claim 3, Takahashi teaches all of the limitations of claim 1 as discussed above. However, Takahashi does not explicitly teach wherein the first imaging element and the circuitry are in a single chip.
In the same field of endeavor, Kaihatsu teaches wherein the first imaging element and the circuitry are in a single chip (i.e., an imaging apparatus may be in the form of a single chip, or may be in the form of a module that is formed by packaging the portion in which the imaging device 15 is formed and the sensor signal processing unit 18) (col. 21, lines 28-37).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Kaihatsu because Kaihatsu teaches an AF drive control unit and an imaging device having the ability to form an image and control the imaging target through a lens driver (See, for example, Figs. 1-2 and col. 2, lines 42-50 of Kaihatsu). Therefore, it would have been obvious to combine the teachings of Takahashi with those of Kaihatsu.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Takahashi et al. (U.S. Patent No. 11,307,399; WO2013/179723 cited in IDS filed 8/29/22) in view of Wakui (U.S. Pub. No. 2020/0192059) and in view of Ichiki (U.S. Pub. No. 2019/0083180).
In regard to claim 5, Takahashi teaches all of the limitations of claim 1 as discussed above. However, Takahashi does not explicitly teach wherein the first image data is at least one of bright-field image data or fluorescence image data.
In the same field of endeavor, Wakui teaches wherein the first image data is at least one of bright-field image data (i.e., present invention may be applied to a bright field microscope) (para[0133]).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Wakui because Wakui teaches imaging of an observation target according to an auto-focus control in order to evaluate the observation target with accuracy and high reliability (See, for example, Fig. 1 and para[0026]-[0028] of Wakui). Therefore, it would have been obvious to combine the teachings of Takahashi with those of Wakui.
However, Wakui does not explicitly teach wherein the first image data is…or fluorescence image data.
In the same field of endeavor, Ichiki teaches wherein the first image data is…or fluorescence image data (i.e., the special light observation may perform fluorescence observation to obtain and image by fluorescence generated by emission of the excitation light) (para[0087]).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Wakui with those of Ichiki because Ichiki teaches camera control signals that designate information associated with imaging conditions, such as information designating a frame rate of a captured image, information designating an exposure value at the time of imaging, and/or information designating the magnification and focus of the captured image (See, for example, para[0099] of Ichiki). Therefore, it would have been obvious to combine the teachings of Takahashi and Wakui with those of Ichiki.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Takahashi et al. (U.S. Patent No. 11,307,399; WO2013/179723 cited in IDS filed 8/29/22) and in view of Wakui (U.S. Pub. No. 2020/0192059).
In regard to claim 6, Takahashi teaches all of the limitations of claim 1 as discussed above. However, Takahashi does not explicitly teach wherein the first image data is an image signal including at least one of a luminance value or a frequency.
In the same field of endeavor, Wakui teaches wherein the first image data is an image signal including at least one of a luminance value or a frequency (i.e., a spatial frequency distribution of the phase difference image).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Wakui because Wakui teaches imaging of an observation target according to an auto-focus control in order to evaluate the observation target with accuracy and high reliability (See, for example, Fig. 1 and para[0026]-[0028] of Wakui). Therefore, it would have been obvious to combine the teachings of Takahashi with those of Wakui.
Claims 7-8 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi et al. (U.S. Patent No. 11,307,399; WO2013/179723 cited in IDS filed 8/29/22) and in view of Ichiki (U.S. Pub. No. 2019/0083180).
In regard to claim 7, Takahashi teaches all of the limitations of claim 1 as discussed above. However, Takahashi does not explicitly teach wherein the feature related to the target includes a feature related to an attribute of the target.
In the same field of endeavor, Ichiki teaches wherein the feature related to the target includes a feature related to an attribute of the target (i.e., fluorescence observation can be used to observe fluorescence emitted from a body tissue to which excitation light is applied (autofluorescence observation), and can be used in a case where a reagent such as indocyanine green (ICG) is locally administered to the body tissue, and together with this, excitation light corresponding to the fluorescence wavelength of the reagent is applied to the body tissue to obtain a fluorescent image, or the like) (para[0087]).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Ichiki because Ichiki teaches camera control signals that designate information associated with imaging conditions, such as information designating a frame rate of a captured image, information designating an exposure value at the time of imaging, and/or information designating the magnification and focus of the captured image (See, for example, para[0099] of Ichiki). Therefore, it would have been obvious to combine the teachings of Takahashi with those of Ichiki.
In regard to claim 8, Takahashi and Ichiki teach all of the limitations of claims 1 and 7 as discussed above. However, Takahashi does not explicitly teach wherein the feature related to the attribute of the target includes at least one of a feature related to an attribute of the living tissue, a feature related to an autofluorescence component, or a feature related to a lesion in the living tissue.
In the same field of endeavor, Ichiki teaches wherein the feature related to the attribute of the target includes at least one of a feature related to an attribute of the living tissue (i.e., the special light observation is used to perform narrow-band observation (narrow band imaging) of utilizing the wavelength dependency of the light absorption in the body tissue so as to apply light in a narrower band compared with the irradiation light (that is, white light) at the time of ordinary observation to photograph a predetermined tissue such as a blood vessel of the mucosal surface layer with high contrast) (para[0086]), a feature related to an autofluorescence component (i.e., fluorescence observation can be used to observe fluorescence emitted from a body tissue to which excitation light is applied (autofluorescence observation), and can be used in a case where a reagent such as indocyanine green (ICG) is locally administered to the body tissue, and together with this, excitation light corresponding to the fluorescence wavelength of the reagent is applied to the body tissue to obtain a fluorescent image, or the like) (para[0087]), or a feature related to a lesion in the living tissue.
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Ichiki for the same reasons as those discussed above for claim 7.
In regard to claim 15, Takahashi teaches all of the limitations of claims 1 and 12 as discussed above. However, Takahashi does not explicitly teach wherein the circuitry is further configured to control at least one of a gain or an exposure time.
In the same field of endeavor, Ichiki teaches wherein the circuitry is further configured to control at least one of a gain or an exposure time (i.e., the communication unit 26 receives a control signal for controlling driving of the camera head 23; the control signal includes, for example, information associated with imaging condition, such as…information designating an exposure value at the time of imaging) (para[0099]).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Ichiki for the same reasons as those discussed above for claim 7.
In regard to claim 16, Takahashi and Ichiki teach all of the limitations of claims 1, 12, and 15 as discussed above. However, Takahashi does not explicitly teach wherein the circuitry is further configured to control at least one of the gain or the exposure time in units of pixels, or in units of wavelengths.
In the same field of endeavor, Ichiki teaches wherein the circuitry is further configured to control at least one of the gain or the exposure time in units of pixels, or in units of wavelengths (i.e., the communication unit 26 receives a control signal for controlling driving of the camera head 23; the control signal includes, for example, information associated with imaging condition, such as…information designating an exposure value at the time of imaging; note that the imaging conditions such as the above frame rate, exposure value, magnification, focus are automatically set by the control unit 85 of the CCU 51 on the basis of the obtained image signal; in addition, while the vicinity region is described as a 3×3 region around a target pixel as illustrated in Fig. 13, it is allowable to perform calculation assuming a wider region such as a 5×5 region and a 7×7 region) (para[0099], [0101], [0169]).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Ichiki for the same reasons as those discussed above for claim 7.
In regard to claim 17, Takahashi teaches all of the limitations of claims 1 and 12 as discussed above. However, Takahashi does not explicitly teach wherein the circuitry is further configured to control a light amount of a light source.
In the same field of endeavor, Ichiki teaches wherein the circuitry is further configured to control a light amount of a light source (i.e., light source apparatus 55; in a case where the white light source is constituted with the combination of the RGB laser light sources, it is possible to control the output intensity and the output timing of individual colors (individual wavelengths) with high accuracy) (para[0083]).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Ichiki for the same reasons as those discussed above for claim 7.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi et al. (U.S. Patent No. 11,307,399; WO2013/179723 cited in IDS filed 8/29/22) and Takahashi (U.S. Patent No. 11,686,721; hereinafter referred to as “Takahashi 2”).
In regard to claim 9, Takahashi teaches all of the limitations of claim 1 as discussed above. However, Takahashi does not explicitly teach wherein the feature related to the target includes a feature related to a corresponding region of the plurality of regions of the target.
In the same field of endeavor, Takahashi 2 teaches wherein the feature related to the target includes a feature related to a corresponding region of the plurality of regions of the target (i.e., even when a foreign matter having a size as large as one pixel is observed in the IHM phase image, that foreign matter is detected as one region in label image 39 and information on where the foreign matter is located can accurately be provided to an operator) (col. 12. Lines 57-67).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Takahashi 2 because Takahashi 2 teaches a plurality of cell image analysis apparatuses each include an image obtaining unit that obtains a cell image including a removal target, the cell image being obtained by a microscope for observation of a cell (See, for example, Fig. 8, col. 4, lines 42-58 of Takahashi 2). Therefore, it would have been obvious to combine the teachings of Takahashi with those of Takahashi 2.
In regard to claim 10, Takahashi and Takahashi 2 teach all of the limitations of claims 1 and 9 as discussed above. However, Takahashi does not explicitly teach wherein the feature related to the corresponding region of the target includes at least one of a feature related to a lesion region in the living tissue or a feature related to a foreign substance in the target.
In the same field of endeavor, Takahashi 2 teaches wherein the feature related to the corresponding region of the target includes at least one of a feature related to a lesion region in the living tissue or a feature related to a foreign substance in the target (i.e., even when a foreign matter having a size as large as one pixel is observed in the IHM phase image, that foreign matter is detected as one region in label image 39 and information on where the foreign matter is located can accurately be provided to an operator) (col. 12. Lines 57-67).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Takahashi 2 for the same reasons as those discussed above for claim 9.
In regard to claim 11, Takahashi teaches all of the limitations of claim 1 as discussed above. However, Takahashi does not explicitly teach wherein the circuitry is further configured to execute the determination based on a learned model.
In the same field of endeavor, Takahashi 2 teaches wherein the circuitry is further configured to execute the determination based on a learned model (i.e., the cell image analysis apparatus includes a trained-model generator that carries out machine learning using a plurality of training data sets generated by the training data set generator and generates a trained model for identifying the removal target within an image and a detector that detects the removal target region in an input image input to the cell image analysis apparatus based on the trained model) (col. 3, line 64-col. 4, line 4).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Takahashi 2 for the same reasons as those discussed above for claim 9.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Takahashi et al. (U.S. Patent No. 11,307,399; WO2013/179723 cited in IDS filed 8/29/22) and Trulson et al. (U.S. Patent No. 11,690,696)
In regard to claim 18, Takahashi teaches all of the limitations of claims 1 and 12 as discussed above. However, Trulson does not explicitly teach wherein the image processing operation includes a fluorescence separation processing operation.
In the same field of endeavor, Trulson teaches wherein the image processing operation includes a fluorescence separation processing operation (i.e., cross talk from reflection and/or fluorescence from the stimulation light can be reduced or eliminated by providing spectral separation between the imaging light and the stimulation light) (col. 24, lines 16-41).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the invention, to combine the teachings of Takahashi and Trulson because Trulson teaches a microscope for simultaneous imaging and stimulation of tissue within a subject with the added advantage of the microscope being extremely compact in size (i.e., total volume of less than one cubic inch) (See, for example, col. 1, lines 32-46). Therefore, it would have been obvious to combine the teachings of Takahashi with those of Trulson.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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KRISTIN DOBBS
Examiner
Art Unit 2488
/KRISTIN DOBBS/Examiner, Art Unit 2488
/SATH V PERUNGAVOOR/Supervisory Patent Examiner, Art Unit 2488