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
The amendments to claims 1, 9, 20 and 21 in the response filed on 07/06/2026 are acknowledged.
Claims 1-21 remain pending in the application
Claims 1-21 are examined.
Response to Arguments
Applicant's arguments filed 07/06/2026 have been fully considered but they are not persuasive.
Applicant argues that Saito does not teach claim 1 and claim 20 because Saito does not teach the limitation “a fault detection unit is configured to detect the presence of a fault in the image acquisition and to determine a fault state of the image acquisition independently of the analysis of the image data and the calculated analysis parameter”. Applicant argues that the "warning notification unit" in Saito relies on the same signal ratios (R2/G2, B1/G2, G2/B2) that are also used to calculate physiological parameters (oxygen saturation, blood volume). The fault detection is therefore not independent of the analysis of the image data and the calculated analysis parameter.
The examiner respectfully disagrees. First, the examiner notes that the present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Secondly the examiner notes that Saito teaches the special observation image processing unit 64 as the evaluation unit. The “analysis of the spatially and spectrally resolved image data” is done in the structure enhancement section 78, which is “based on spatial and spectral information”. The analysis parameter is the input to 78, which can be seen in Fig. 8. The input is based on 83, the oxygen saturation calculation section, and the image signal. Saito teaches the “fault detection unit” as the warning notification unit 65, which determines a fault based on the ratios signal ratio B1/G2 and the signal ratio R2/G2 and signal ratio G2/B2. Saito’s warning notification unit 65 determines the fault independently of 83. The claim does not recite how the evaluation unit analyzes the data, and the claim does not recite how the analysis parameter is calculated. The claim also does not recite how the fault state is determined. Therefore, Saito does teach the limitations as recited in claim 1 and similarly claim 20.
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.
Claim(s) 1, 2, 4, 5, 7, 17, 18, 19, 20, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saito (US 2015/0238127 A1).
Regarding claim 1, Saito discloses a medical imaging device, comprising:a spatially and spectrally resolving image acquisition unit (Fig. 2, [0051]) comprising at least one optical system (46, 47, Fig. 2, [0051]) and at least one image acquisition sensor system coupled to the optical system (48, Fig. 2, [0051]), which are configured to carry out an image acquisition of an image region ([0051]), in which unit spatially and spectrally resolved image data are generated which comprise both spatial and spectral information ([0052]); an evaluation unit which is configured to create an analysis of the spatially and spectrally resolved image data that is based on spatial and spectral information and based on at least one analysis parameter calculated from the spatially and spectrally resolved image data ([0077]);a fault detection unit which is configured to detect the presence of a fault in the image acquisition and to determine a fault state of the image acquisition independently of the analysis of the image data and the calculated analysis parameter (warning notification unit, [0078]); and an output unit configured to generate a user output based on the analysis parameter in accordance with the fault state ([0081]-[0083]- display image signal generation unit).
Regarding claim 2, Saito discloses the medical imaging device according to claim 1 wherein the fault detection unit is configured to detect the presence of a fault based on an assessment of the spatially and spectrally resolved image data ([0079]).
Regarding claim 4, Saito discloses the medical imaging device according to claim 2 wherein the fault detection unit is configured to detect the presence of a fault by detecting inorganic material in the image region ([0078]-[0079]).
Regarding claim 5, Saito discloses the medical imaging device according to claim 1 further comprising a video acquisition unit which comprises a camera ([0044])and which is configured to generate video image data of the image region ([0044]), wherein the fault detection unit is configured to detect the presence of a fault based on an image analysis of the video image data ([0044]).
Regarding claim 7, Saito discloses the medical imaging device according to claim 5, wherein the fault detection unit is configured to detect the presence of soiling and/or fogging on at least part of the optical system of the spatially and spectrally resolving image acquisition unit based on the image analysis of the video image data and to detect the presence of a fault in accordance with the detection of soiling and/or fogging ([0023], [0077]-[0078]).
Regarding claim 17, Saito discloses the medical imaging device according to claim 1, wherein the fault detection unit is configured to prevent the acquisition of spatially and spectrally resolved image data by means of the spatially and spectrally resolving image acquisition unit in the event of a fault being detected([0023], [0077]-[0078]).
Regarding claim 18, Saito discloses the medical imaging device according to claim 1, wherein the output unit is configured to generate a spatially resolved parameter representation of the image region in accordance with the analysis parameter and to be identified by the fault detection unit as faulty parts of the image region (Fig. 16, [0092])
Regarding claim 19, Saito discloses the medical imaging device according to claim 1, wherein the output unit is configured to provide the user, in the event of a fault being detected, with information on how to remedy the fault ([0091]-[0092]).
Regarding claim 20, Saito discloses a method for operating a medical imaging device, comprising the steps of: -acquiring spatially and spectrally resolved image data of an image region by means of the medical imaging device ([0044]); -creating an analysis of the spatially and spectrally resolved image data that is at least based on spatial and spectral information and further at least based on at least one analysis parameter determined from the spatially and spectrally resolved image data ([0077]); -performing a fault detection in which, independently of the analysis of the image data and the calculated analysis parameter, the presence of a fault in the image acquisition is detected and in which a fault state of the image acquisition is determined ([0078]); and -generating a user output according to the fault state based on the analysis parameter([0081]-[0083]- display image signal generation unit).
Regarding claim 21, The method according to claim 20, further comprising: -performing an image acquisition of the image region -in which the spatially and spectrally resolved image data are generated which comprise both spatial and spectral information ([0044]).
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.
Claim(s) 3, 6, is/are rejected under 35 U.S.C. 103 as being unpatentable over Saito (US 20150238127 A1) in view of Rittscher et al. (US 2022/0207728 A1, hereinafter “Rittscher”).
Regarding claim 3, Saito discloses the medical imaging device according to claim 2, but Saito fails to expressly teach wherein the fault detection unit is configured to detect an image exposure state based on the spatially and spectrally resolved image data and to detect the presence of a fault if the exposure state represents an underexposure and/or an overexposure at least in portions.
However, Rittscher teaches of a medical imaging device (1, Fig. 1, [0072]) wherein the fault detection unit is configured to detect an image exposure state based on the spatially and spectrally resolved image data and to detect the presence of a fault if the exposure state represents an underexposure and/or an overexposure at least in portions ([0072]-[0084]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Saito to utilize the fault detection unit as taught by Rittscher. It would have been advantageous to make the combination for the purpose of making features of the object less difficult to discern ([0072] of Rittscher).
Regarding claim 6, Saito discloses the medical imaging device according to claim 5, but Saito fails to expressly teach wherein the fault detection unit is configured to determine a range of motion of the camera relative to the image region based on the image analysis of the video image data and to detect the presence of a fault if the determined range of motion exceeds a threshold value.
However, Rittscher teaches of a medical imaging device (1, Fig. 1, [0072]) wherein the fault detection unit is configured to determine a range of motion of the camera relative to the image region based on the image analysis of the video image data and to detect the presence of a fault if the determined range of motion exceeds a threshold value ([0013], [0125], [0144], [0152]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Saito to utilize the fault detection unit as taught by Rittscher. It would have been advantageous to make the combination for the purpose of making features of the object less difficult to discern ([0072] of Rittscher).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saito (US 20150238127 A1) in view of Kitsunai (US 20200367976 A1).
Regarding claim 8, Saito discloses the medical imaging device according to claim 1, but Saito fails to expressly teach wherein the fault detection unit is configured to assess, based on a comparison of the spatially and spectrally resolved image data and the video image data, whether a white balance of the spatially and spectrally resolving image acquisition unit and a white balance of the video acquisition unit are consistent at least within a predetermined tolerance and to detect the presence of a fault if the predetermined tolerance is exceeded.
However, Kitsunai teaches of a medical imaging device (1, Fig. 1, [0033]) wherein the fault detection unit is configured to assess, based on a comparison of the spatially and spectrally resolved image data and the video image data, whether a white balance of the spatially and spectrally resolving image acquisition unit and a white balance of the video acquisition unit are consistent at least within a predetermined tolerance and to detect the presence of a fault if the predetermined tolerance is exceeded ([0117]-[0138]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Saito to utilize a fault detection unit as taught by Kitsunai. It would have been advantageous to make the combination for the purpose of determining the error ([0017] of Kitsunai).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saito (US 20150238127 A1) in view of Ichikawa (US 20210295980 A1).
Regarding claim 9, Saito discloses the medical imaging device according to claim 5, but Saito fails to expressly teach wherein the fault detection unit is configured to detect unexpected presence of a medical instrument in the image region based on the image analysis of the video image data and to detect the presence of a fault in accordance with the detection of the unexpected presence of the medical instrument.
However, Ichikawa teaches of a medical imaging device (Fig. 1) wherein the fault detection unit is configured to detect the unexpected presence of a medical instrument in the image region based on the image analysis of the video image data and to detect the presence of a fault in accordance with the detection of an unexpected presence of a medical instrument ([0041]-[0063]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Saito to utilize a fault detection unit as taught by Ichikawa. It would have been advantageous to make the combination for the purpose of detecting the instrument ([0007]).
Regarding claim 10, Saito, in view of Ichikawa discloses the medical imaging device according to claim 9, and Saito, in view of Ichikawa fails to expressly teach wherein the imaging device comprises a distal end, which comprises at least parts of the optical system of the image acquisition unit, wherein the fault detection unit is configured to detect that the image region at least partially comprises an interior of a trocar, and wherein the output unit is configured to generate a user output containing the information that the distal end is at least partially located within the trocar.
However, Ichikawa further teaches a medical imaging device wherein the imaging device comprises a distal end, which comprises at least parts of the optical system of the image acquisition unit, wherein the fault detection unit is configured to detect that the image region at least partially comprises an interior of a trocar, and wherein the output unit is configured to generate a user output containing the information that the distal end is at least partially located within the trocar ([0041]-[0063]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Saito to utilize a fault detection unit as taught by Ichikawa. It would have been advantageous to make the combination for the purpose of detecting the instrument ([0007]).
Claim(s) 11, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saito (US 20150238127 A1) in view of Yoshizaki (US 2017/0360275 A1).
Regarding claim 11, Saito discloses the medical imaging device according to claim 1, but Saito fails to expressly teach further comprising a fluorescence imaging unit which is configured to acquire the image region by fluorescence imaging and to generate fluorescence imaging data, wherein the fault detection unit is configured to detect the presence of a fault based on an assessment of the fluorescence imaging data.
However, Yoshizaki teaches of a medical imaging device (1, Fig. 1, [0038]) further comprising a fluorescence imaging unit which is configured to acquire the image region by fluorescence imaging and to generate fluorescence imaging data, wherein the fault detection unit is configured to detect the presence of a fault based on an assessment of the fluorescence imaging data ([0004]-[0007], [0037], [0066]-[0076]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Saito to utilize a fluorescence imaging unit as taught by Yoshizaki. It would have been advantageous to make the combination for the purpose of determining if the fluorescent agent is in the steady state (Abstract).
Regarding claim 12, Saito discloses the medical imaging device according to claim 1, but Saito fails to expressly teach wherein the fault detection unit is configured to detect the presence of contrast agent in at least a portion of the image region based on the fluorescence imaging data, and wherein the output unit is configured to generate the user output based on the analysis parameter such that parts of the image region in which the fault detection unit detects a presence of contrast agent are omitted.
However, Yoshizaki teaches of a medical imaging device (1, Fig. 1, [0038]) herein the fault detection unit is configured to detect the presence of contrast agent in at least a portion of the image region based on the fluorescence imaging data, and wherein the output unit is configured to generate the user output based on the analysis parameter such that parts of the image region in which the fault detection unit detects a presence of contrast agent are omitted ([0004]-[0007], [0037], [0066]-[0076]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Saito to utilize a contrast agent as taught by Yoshizaki. It would have been advantageous to make the combination for the purpose of determining if the fluorescent agent is in the steady state (Abstract).
Claim(s) 13, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saito (US 20150238127 A1) in view of Shelton et al. (US 2021/0196098 A1, hereinafter “Shelton”).
Regarding claim 13, Saito discloses the medical imaging device according to claim 1, but Saito fails to expressly teach further comprising a sensor unit having at least one sensor which is configured to measure at least one measured variable which describes a state of the imaging device and/or an environment of the imaging device, and which unit is configured to generate a sensor signal which represents the measured variable, wherein the fault detection unit is configured to detect the presence of a fault based on the sensor signal.
However, Shelton teaches of a medical imaging device (Fig. 1) further comprising a sensor unit having at least one sensor which is configured to measure at least one measured variable which describes a state of the imaging device and/or an environment of the imaging device, and which unit is configured to generate a sensor signal which represents the measured variable, wherein the fault detection unit is configured to detect the presence of a fault based on the sensor signal ([0211]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Saito to utilize a sensor unit as taught by Shelton. It would have been advantageous to make the combination for the purpose of triangulating the distance from the surgical device to the critical structure based on the known positions of the surgical device and the camera ([0211] of Shelton).
Regarding claim 15, Saito discloses the medical imaging device according to claim 13, but Saito fails to expressly teach wherein the sensor is a distance sensor configured to determine a distance between the imaging device and an object in the image region.
However, Shelton teaches of a medical imaging device wherein the sensor is a distance sensor configured to determine a distance between the imaging device and an object in the image region ([0147]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Saito to utilize a sensor as taught by Shelton. It would have been advantageous to make the combination for the purpose of triangulating the distance from the surgical device to the critical structure based on the known positions of the surgical device and the camera ([0211] of Shelton).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saito (US 20150238127 A1) in view of Shelton et al. (US 2021/0196098 A1, hereinafter “Shelton”) and Kuriyama (US 20170319051 A1).
Regarding claim 14, Saito, in view of Shelton discloses the medical imaging device according to claim 13, but Saito, in view of Shelton fails to expressly teach wherein the sensor is an acceleration sensor, wherein the sensor signal represents a movement of the imaging device, and wherein the fault detection unit is configured to determine a range of motion based on the sensor signal and to detect the presence of a fault when the determined range of motion exceeds a threshold value.
However, Kuriyama teaches of a medical imaging device (2, Fig. 1, [0038]) wherein the sensor is an acceleration sensor, wherein the sensor signal represents a movement of the imaging device, and wherein the fault detection unit is configured to determine a range of motion based on the sensor signal and to detect the presence of a fault when the determined range of motion exceeds a threshold value ([0147]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Saito, to utilize an acceleration sensor, as taught by Kuriyama. It would have been advantageous to make the combination for the purpose of detecting motion ([0147] of Kuriyama).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTEN A. SHARPLESS whose telephone number is (571)272-2387. The examiner can normally be reached Monday-Tuesday 6:00 AM - 2:00 PM, and Friday 6:00 AM - 10:00 AM.
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/C.A.S./Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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