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 .
Status of Claims
Claims 1-20 are pending and are currently under consideration for patentability under 37 CFR 1.104.
Claim Objections
Claims 16 and 18 are objected to because of the following informalities:
In claim 16, on line 14, change “an energy device” to “the energy device” (i.e., previously recited).
In claim 18, change “a second threshold value” to “the second threshold value” (i.e., previously recited).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 11, the limitation “obtain a fist pixel value…obtain a second pixel value” fails to comply with the written description requirement. The specification describes using an average value PAV (or a pixel value of at least one pixel) and comparing it to a first threshold value, a second threshold value, and a third threshold value ([0072]). The specification does not describe obtaining two separate pixel values and comparing them to the first and second threshold values respectively. Therefore, claims 1 and 11 contain subject matter not described in the specification. Claims 2-10 and 12-15 are rejected due to their dependency on claims 1 and 11.
Regarding claims 2 and 12, the limitation “extracting a pixel value that exceeds a third threshold value” fails to comply with the written description requirement. Similar to above, the specification describes using an average value PAV (or a pixel value of at least one pixel) and comparing it to a first threshold value, a second threshold value, and a third threshold value ([0072]). The specification does not describe extracting a separate pixel value and comparing it to the third threshold value (i.e., “exceeds”). Therefore, claims 2 and 12 contain subject matter not described in the specification.
Regarding claim 8, the limitation “an image of a fluorescence” is unclear. Claim 1 recites “generate a fluorescence image”. It is unclear if claim 8 is referring to a different fluorescence image or the same fluorescence image.
Regarding claim 16, the limitation “deterring whether a first value….determine whether a second value” fails to comply with the written description requirement. The specification describes using an average value PAV (or a pixel value of at least one pixel) and comparing it to a first threshold value, a second threshold value, and a third threshold value ([0072]). The specification does not describe determining two separate values and comparing them to the first and second threshold values respectively. Therefore, claim 16 contains subject matter not described in the specification. Claims 17-20 are rejected due to their dependency on claim 16.
Regarding claim 17, the limitation “extracting the pixel value that exceeds a third threshold value” fails to comply with the written description requirement. Similar to above, the specification describes using an average value PAV (or a pixel value of at least one pixel) and comparing it to a first threshold value, a second threshold value, and a third threshold value ([0072]). The specification does not describe extracting a separate pixel value and comparing it to the third threshold value (i.e., “exceeds”). Therefore, claim 17 contains subject matter not described in the specification.
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.
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(s) 1, 3, 9-11, 13, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kokubo (JP2017023604, provided in IDS 02/05/2025 with translation provided by parent application 17/461,446), in view of Connors (US 2013/0190742).
Regarding claim 1, Kokubo discloses a medical system (1, figure 2) comprising: a processor (video processor 4, figure 2) including a memory (memory in 42, [0039]) and being configured to: generate a fluorescence image based on an image pickup signal obtained by imaging a living body tissue irradiated with an excitation light (fluorescence imaging system…[0025]); extract a heat invasion region (extracting…attention region Ai1 [0079]) that includes a group of pixels among a plurality of pixels included in the fluorescence image (determines…region of interest Ai1 [0083]); obtain a first pixel value of the group of pixels (brightness of the region of interest Ai1…[0083]); obtain a second pixel value of the group of pixels (brightness of the region of interest Ai1…[0083]); determine whether a second value exceeds a second threshold value (determines that the brightness…is equal to or lower than the threshold value [0083] | broadly interpreted “exceeds” to mean to go beyond a set limit, the set limit being equal to or lower than the threshold value), the second value is regarding the second pixel value ([0083]); responsive to determining the second value exceeds the second threshold value, output a second control signal configured to stop energy supply to the energy device (instructing the ablation control unit…stop the ablation energy output [0084]). Kokubo is silent regarding determine whether a first value exceeds a first threshold value, the first value is regarding the first pixel value; responsive to determining the first value exceeds the first threshold value, output a first control signal configured to decrease energy supply to an energy device; subsequent to outputting the first control signal, obtain the second pixel value of the group of pixels.
Connors teaches a system (100, figure 1) and method for removing tissue using laser ablation ([0028]). The system has a laser source and control system (115, figure 1) that controls the positioning and optical parameters of each of the lasers utilizing the process controller (200, figure 2; [0038]). A detector (170, figure 1), such as a camera system that has image processing functions to detect optical signatures, would produce an output signal related to respective optical signature that would be provided to the laser source and control system ([0048]). In the process controller, iterative measurements are taken of the changes in the necrotic tissue height and position using the detector ([0090] | 230, figure 2). An assessment is made by the process controller as to whether the necrotic tissue is sufficiently ablated (240, figure 2). If no, the position and optical parameters controller (160, figure 1) will adjust the integrated fluence after the determination is made to either decrease, maintain, or increase the fluence and pulse rate (270, 280, and 290, figure 2; [0090]). The decrease in fluence and pulse rate may also include the option for the laser ablation to be terminated ([0090]).
It would have been obvious to modify the system of Kokubo with the laser source and control system (115, figure 1) as taught by Connors. Doing so would provide iterative measurements to control tissue ablation ([0090]). The modified system would have determine whether a first value exceeds a first threshold value (determination unit….threshold value [0083]; Kokubo | determination…integrated fluence is decreased [0090]; Connors | the modified device would determine if the brightness of the Ai1 is above the threshold value in [0083] of Kokubo but below another threshold to determine if the fluence needs to be decreased in 260-270, figure 2 of Connors), the first value is regarding the first pixel value; responsive to determining the first value exceeds the first threshold value, output a first control signal configured to decrease energy supply to an energy device (270, figure 2; Connors); subsequent to outputting the first control signal, obtain the second pixel value of the group of pixels (iterative measurements [0090]; Connors).
Regarding claim 3, Kokubo and Connors further disclose the first threshold value is smaller than the second threshold value (determination unit….threshold value [0083]; Kokubo | determination…integrated fluence is decreased [0090]; Connors | the modified device would determine if the brightness of the Ai1 is above the threshold value in [0083] of Kokubo but below another threshold to determine if the fluence needs to be decreased in 260-270, figure 2 of Connors).
Regarding claim 9, Kokubo further discloses a light source (3, figure 2) is configured to emit in an alternating manner (switch…[0021]-[0022]) between the excitation light (32, figure 2) and a white light (31, figure 2), and wherein the processor is configured to: generate a white light image based on an image pickup signal obtained by imaging the living body tissue irradiated with the white light (signal obtained from white light image pickup system 12, [0027]; processed into a white light observation image [0042]), and cause a display to display a display image including the fluorescence image and the white light image (display apparatus 6 displays an image 6a including the fluorescence image 8bf, figure 5d and the white light image 8bi, figure 5a).
Regarding claim 10, Kokubo further discloses a light source configured to generate the excitation light (32, figure 2 | [0021]).
Regarding claim 11, Kokubo discloses an energy control method comprising: generating a fluorescence image based on an image pickup signal obtained by imaging a living body tissue irradiated with an excitation light (fluorescence imaging system…[0025]); extracting a heat invasion region (extracting…attention region Ai1 [0079]) that includes a group of pixels among a plurality of pixels included in the fluorescence image (determines…region of interest Ai1 [0083]); obtaining a first pixel value of the group of pixels (brightness of the region of interest Ai1…[0083]); obtaining a second pixel value of the group of pixels (brightness of the region of interest Ai1…[0083]); determining whether a second value exceeds a second threshold value (determines that the brightness…is equal to or lower than the threshold value [0083] | broadly interpreted “exceeds” to mean to go beyond a set limit, the set limit being equal to or lower than the threshold value), the second value is regarding the second pixel value ([0083]); responsive to determining the second value exceeds the second threshold value, outputting a second control signal configured to stop energy supply to the energy device (instructing the ablation control unit…stop the ablation energy output [0084]). Kokubo is silent regarding determining whether a first value exceeds a first threshold value, the first value is regarding the first pixel value; responsive to determining the first value exceeds the first threshold value, outputting a first control signal configured to decrease energy supply to an energy device; subsequent to outputting the first control signal, obtaining the second pixel value of the group of pixels.
Connors teaches a system (100, figure 1) and method for removing tissue using laser ablation ([0028]). The system has a laser source and control system (115, figure 1) that controls the positioning and optical parameters of each of the lasers utilizing the process controller (200, figure 2; [0038]). A detector (170, figure 1), such as a camera system that has image processing functions to detect optical signatures, would produce an output signal related to respective optical signature that would be provided to the laser source and control system ([0048]). In the process controller, iterative measurements are taken of the changes in the necrotic tissue height and position using the detector ([0090] | 230, figure 2). An assessment is made by the process controller as to whether the necrotic tissue is sufficiently ablated (240, figure 2). If no, the position and optical parameters controller (160, figure 1) will adjust the integrated fluence after the determination is made to either decrease, maintain, or increase the fluence and pulse rate (270, 280, and 290, figure 2; [0090]). The decrease in fluence and pulse rate may also include the option for the laser ablation to be terminated ([0090]).
It would have been obvious to modify the method of Kokubo to use the laser source and control system (115, figure 1) as taught by Connors. Doing so would provide iterative measurements to control tissue ablation ([0090]). The modified method would comprise determining whether a first value exceeds a first threshold value (determination unit….threshold value [0083]; Kokubo | determination…integrated fluence is decreased [0090]; Connors | the modified device would determine if the brightness of the Ai1 is above the threshold value in [0083] of Kokubo but below another threshold to determine if the fluence needs to be decreased in 260-270, figure 2 of Connors), the first value is regarding the first pixel value; responsive to determining the first value exceeds the first threshold value, outputting a first control signal configured to decrease energy supply to an energy device (270, figure 2; Connors); subsequent to outputting the first control signal, obtaining the second pixel value of the group of pixels (iterative measurements [0090]; Connors).
Regarding claim 13, Kokubo and Connors further disclose the first threshold value is smaller than a second threshold value (determination unit….threshold value [0083]; Kokubo | determination…integrated fluence is decreased [0090]; Connors | the modified device would determine if the brightness of the Ai1 is above the threshold value in [0083] of Kokubo but below another threshold to determine if the fluence needs to be decreased in 260-270, figure 2 of Connors).
Regarding claim 16, Kokubo discloses a processor (4, figure 2) comprising a processing circuit (see 4, figure 2), the processing circuit being configured to: generate a fluorescence image based on an image pickup signal obtained by imaging a living body tissue irradiated with excitation light (fluorescence imaging system…[0025]); extract a heat invasion region (extracting…attention region Ai1 [0079]) that includes a group of pixels having a pixel value among a plurality of pixels included in the fluorescence image (determines…region of interest Ai1 [0083]); determine whether a second value exceeds a second threshold value (determines that the brightness…is equal to or lower than the threshold value [0083] | broadly interpreted “exceeds” to mean to go beyond a set limit, the set limit being equal to or lower than the threshold value), the second value is regarding the pixel value of the group of pixels ([0083]); responsive to determine the second value exceeds the second threshold value, output a second control signal configured to stop energy supply to an energy device (instructing the ablation control unit…stop the ablation energy output [0084]). Kokubo is silent regarding determine whether a first value exceeds a first threshold value, the first value is regarding the pixel value of the group of pixels; responsive to determine the first value exceeds the first threshold value, output a first control signal configured to decrease energy supply to an energy device; subsequent to outputting the first control signal, determine whether the second value exceeds the second threshold value.
Connors teaches a system (100, figure 1) and method for removing tissue using laser ablation ([0028]). The system has a laser source and control system (115, figure 1) that controls the positioning and optical parameters of each of the lasers utilizing the process controller (200, figure 2; [0038]). A detector (170, figure 1), such as a camera system that has image processing functions to detect optical signatures, would produce an output signal related to respective optical signature that would be provided to the laser source and control system ([0048]). In the process controller, iterative measurements are taken of the changes in the necrotic tissue height and position using the detector ([0090] | 230, figure 2). An assessment is made by the process controller as to whether the necrotic tissue is sufficiently ablated (240, figure 2). If no, the position and optical parameters controller (160, figure 1) will adjust the integrated fluence after the determination is made to either decrease, maintain, or increase the fluence and pulse rate (270, 280, and 290, figure 2; [0090]). The decrease in fluence and pulse rate may also include the option for the laser ablation to be terminated ([0090]).
It would have been obvious to modify the processor of Kokubo with the laser source and control system (115, figure 1) as taught by Connors. Doing so would provide iterative measurements to control tissue ablation ([0090]). The modified processor would determine whether a first value exceeds a first threshold value (determination unit….threshold value [0083]; Kokubo | determination…integrated fluence is decreased [0090]; Connors | the modified device would determine if the brightness of the Ai1 is above the threshold value in [0083] of Kokubo but below another threshold to determine if the fluence needs to be decreased in 260-270, figure 2 of Connors), the first value is regarding the pixel value of the group of pixels ([0083]; Kokubo); responsive to determine the first value exceeds the first threshold value, output a first control signal configured to decrease energy supply to an energy device (270, figure 2; Connors); subsequent to outputting the first control signal, determine whether the second value exceeds the second threshold value (iterative measurements [0090]; Connors).
Regarding claim 18, Kokubo and Connors further disclose the first threshold value is smaller than a second threshold value (determination unit….threshold value [0083]; Kokubo | determination…integrated fluence is decreased [0090]; Connors | the modified device would determine if the brightness of the Ai1 is above the threshold value in [0083] of Kokubo but below another threshold to determine if the fluence needs to be decreased in 260-270, figure 2 of Connors).
Claim(s) 2, 12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kokubo (JP2017023604) and Connors (US 2013/0190742) as applied to claims 1, 11, and 16 above, and further in view of Van Der Weide (US 2012/0209257).
Regarding claim 2, Kokubo and Connors disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the extracting the heat invasion comprises extracting a pixel value that exceeds a third threshold value among the plurality of pixels included in the fluorescence image; and the third threshold value is smaller than the first threshold value.
Van Der Weide teaches an energy delivery system with a power supply, a transmission line, a power distribution component (i.e., power splitter), a processor, and an imaging system (see figure 1). The power distribution system provides varying energy levels to different energy delivery devices ([0093]). The imaging system may comprise imaging devices for fluoroscopy ([0164]). The invention provides software designed to automatically obtain images of a tissue region, automatically detect any changes in the tissue region, and based on the detection to automatically adjust the amount of energy delivered to the tissue region through the energy delivery devices ([0166]).
It would have been obvious to modify the system with a processor and power distribution component (figure 1) as taught by Van Der Weide. Doing so would automatically adjust and vary the amount of energy delivered ([0093] and [0166]). The modified system would have the extracting the heat invasion comprises extracting a pixel value that exceeds a third threshold value among the plurality of pixels included in the fluorescence image (automatically detect any changes…based on the detection to automatically adjust the amount of energy delivered to the tissue region through the energy delivery devices [0166] Van Der Weide | the modified system would determine if the brightness of the Ai1 is below the threshold value in [0083] of Kokubo and to adjust the amount of energy as described in [0166] of Van Der Weide); and the third threshold value is smaller than the first threshold value (the modified system can have a third threshold value that is smaller than the first threshold value, which can drive the adjustment of the amount of energy; [0166] of Van Der Weide).
Regarding claim 12, Kokubo and Connors disclose all of the features in the current invention as shown above in claim 11. They are silent regarding the extracting the heat invasion is extracting a pixel value that exceeds a third threshold value among the plurality of pixels included in the fluorescence image; and the third threshold value is smaller than the first threshold value.
Van Der Weide teaches an energy delivery system with a power supply, a transmission line, a power distribution component (i.e., power splitter), a processor, and an imaging system (see figure 1). The power distribution system provides varying energy levels to different energy delivery devices ([0093]). The imaging system may comprise imaging devices for fluoroscopy ([0164]). The invention provides software designed to automatically obtain images of a tissue region, automatically detect any changes in the tissue region, and based on the detection to automatically adjust the amount of energy delivered to the tissue region through the energy delivery devices ([0166]).
It would have been obvious to modify the method to use a processor and power distribution component (figure 1) as taught by Van Der Weide. Doing so would automatically adjust and vary the amount of energy delivered ([0093] and [0166]). The modified method would comprise the extracting the heat invasion comprises extracting a pixel value that exceeds a third threshold value among the plurality of pixels included in the fluorescence image (automatically detect any changes…based on the detection to automatically adjust the amount of energy delivered to the tissue region through the energy delivery devices in [0166] Van Der Weide | the modified system would determine if the brightness of the Ai1 is below the threshold value in [0083] of Kokubo and to adjust the amount of energy as described [0166] of Van Der Weide); and the third threshold value is smaller than the first threshold value (the modified system can have a third threshold value that is smaller than the first threshold value, which can drive the adjustment of the amount of energy; [0166] of Van Der Weide).
Regarding claim 17, Kokubo and Connors disclose all of the features in the current invention as shown above in claim 16. They are silent regarding the extracting the heat invasion comprises extracting the pixel value that exceeds a third threshold value; and the third threshold is smaller than the first threshold value.
Van Der Weide teaches an energy delivery system with a power supply, a transmission line, a power distribution component (i.e., power splitter), a processor, and an imaging system (see figure 1). The power distribution system provides varying energy levels to different energy delivery devices ([0093]). The imaging system may comprise imaging devices for fluoroscopy ([0164]). The invention provides software designed to automatically obtain images of a tissue region, automatically detect any changes in the tissue region, and based on the detection to automatically adjust the amount of energy delivered to the tissue region through the energy delivery devices ([0166]).
It would have been obvious to modify the processor with the processor and power distribution component (figure 1) as taught by Van Der Weide. Doing so would automatically adjust and vary the amount of energy delivered ([0093] and [0166]). The modified processor would have the extracting the heat invasion comprises extracting the pixel value that exceeds a third threshold value (automatically detect any changes…based on the detection to automatically adjust the amount of energy delivered to the tissue region through the energy delivery devices in [0166] Van Der Weide | the modified system would determine if the brightness of the Ai1 is below the threshold value in [0083] of Kokubo and to adjust the amount of energy as described [0166] of Van Der Weide); and the third threshold is smaller than the first threshold value (the modified system can have a third threshold value that is smaller than the first threshold value, which can drive the adjustment of the amount of energy; [0166] of Van Der Weide).
Claim(s) 4-7, 14-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kokubo (JP2017023604) and Connors (US 2013/0190742) as applied to claims 1, 11, and 16 above, and further in view of Fengler (US 2017/0354392).
Regarding claim 4, Kokubo and Connors disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the first value is an average value of the first pixel value of the group of pixels.
Fengler teaches a processor that can generate a characteristic of a fluorescence video output by (i) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, (ii) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis and dividing the sum of pixel intensities by the square root of the quantity of fluorescence video frames, (iii) averaging pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, or (iv) a combination thereof ([0033]). Alternatively, other manners that is characteristic of the overall pixel intensity of the subregion or a single individual pixel of a subregion may be used ([0080]). Utilizing a representative pixel intensity for multi-pixel subregions may reduce computational complexity ([0080]).
It would have been obvious to modify the processor to utilize a representative pixel intensity as taught by Fengler ([0033] and [0080]). Doing so would reduce computational complexity ([0080]). The modified system would have the first value is an average value of the first pixel value of the group of pixels (averaging pixel intensities…[0033]; Fengler).
Regarding claim 5, Kokubo and Connors disclose all of the features in the current invention as shown above in claim 1, They are silent regarding the first value is a maximum value of the first pixel value of the group of pixels.
Fengler teaches a processor that can generate a characteristic of a fluorescence video output by (i) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, (ii) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis and dividing the sum of pixel intensities by the square root of the quantity of fluorescence video frames, (iii) averaging pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, or (iv) a combination thereof ([0033]). Alternatively, other manners that is characteristic of the overall pixel intensity of the subregion or a single individual pixel of a subregion may be used ([0080]). Utilizing a representative pixel intensity for multi-pixel subregions may reduce computational complexity ([0080]).
It would have been obvious to modify the processor to utilize a representative pixel intensity as taught by Fengler ([0033] and [0080]). Doing so would reduce computational complexity ([0080]). The modified system would have the first value is a maximum value of the first pixel value of the group of pixels (other manner that is characteristic of the overall pixel intensity…a single individual pixel [0080]; Fengler | interpreted a maximum value can be the representative pixel intensity as it can be a characteristic of the overall pixel intensity of the subregion).
Regarding claim 6, Kokubo and Connors disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the second value is an average value of the second pixel value of the group of pixels.
Fengler teaches a processor that can generate a characteristic of a fluorescence video output by (i) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, (ii) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis and dividing the sum of pixel intensities by the square root of the quantity of fluorescence video frames, (iii) averaging pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, or (iv) a combination thereof ([0033]). Alternatively, other manners that is characteristic of the overall pixel intensity of the subregion or a single individual pixel of a subregion may be used ([0080]). Utilizing a representative pixel intensity for multi-pixel subregions may reduce computational complexity ([0080]).
It would have been obvious to modify the processor to utilize a representative pixel intensity as taught by Fengler ([0033] and [0080]). Doing so would reduce computational complexity ([0080]). The modified system would have the second value is an average value of the second pixel value of the group of pixels (averaging pixel intensities…[0033]; Fengler).
Regarding claim 7, Kokubo and Connors disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the second value is a maximum value of the second pixel value of the group of pixels.
Fengler teaches a processor that can generate a characteristic of a fluorescence video output by (i) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, (ii) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis and dividing the sum of pixel intensities by the square root of the quantity of fluorescence video frames, (iii) averaging pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, or (iv) a combination thereof ([0033]). Alternatively, other manners that is characteristic of the overall pixel intensity of the subregion or a single individual pixel of a subregion may be used ([0080]). Utilizing a representative pixel intensity for multi-pixel subregions may reduce computational complexity ([0080]).
It would have been obvious to modify the processor to utilize a representative pixel intensity as taught by Fengler ([0033] and [0080]). Doing so would reduce computational complexity ([0080]). The modified system would have the second value is a maximum value of the second pixel value of the group of pixels (other manner that is characteristic of the overall pixel intensity…a single individual pixel [0080]; Fengler | interpreted a maximum value can be the representative pixel intensity as it can be a characteristic of the overall pixel intensity of the subregion).
Regarding claim 14, Kokubo and Connors disclose all of the features in the current invention as shown above in claim 11. They are silent regarding at least one of the first value or the second value is an average value of pixel values of the plurality of pixels included in the heat invasion region.
Fengler teaches a processor that can generate a characteristic of a fluorescence video output by (i) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, (ii) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis and dividing the sum of pixel intensities by the square root of the quantity of fluorescence video frames, (iii) averaging pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, or (iv) a combination thereof ([0033]). Alternatively, other manners that is characteristic of the overall pixel intensity of the subregion or a single individual pixel of a subregion may be used ([0080]). Utilizing a representative pixel intensity for multi-pixel subregions may reduce computational complexity ([0080]).
It would have been obvious to modify the method to utilize a representative pixel intensity as taught by Fengler ([0033] and [0080]). Doing so would reduce computational complexity ([0080]). The modified method would comprise at least one of the first value or the second value is an average value of pixel values of the plurality of pixels included in the heat invasion region (averaging pixel intensities…[0033]; Fengler).
Regarding claim 15, Kokubo and Connors disclose all of the features in the current invention as shown above in claim 11. They are silent regarding at least one of the first value or the second value is a maximum value of pixel values of the plurality of pixels included in the heat invasion region.
Fengler teaches a processor that can generate a characteristic of a fluorescence video output by (i) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, (ii) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis and dividing the sum of pixel intensities by the square root of the quantity of fluorescence video frames, (iii) averaging pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, or (iv) a combination thereof ([0033]). Alternatively, other manners that is characteristic of the overall pixel intensity of the subregion or a single individual pixel of a subregion may be used ([0080]). Utilizing a representative pixel intensity for multi-pixel subregions may reduce computational complexity ([0080]).
It would have been obvious to modify the method to utilize a representative pixel intensity as taught by Fengler ([0033] and [0080]). Doing so would reduce computational complexity ([0080]). The modified method would comprise at least one of the first value or the second value is a maximum value of pixel values of the plurality of pixels included in the heat invasion region (other manner that is characteristic of the overall pixel intensity…a single individual pixel [0080]; Fengler | interpreted a maximum value can be the representative pixel intensity as it can be a characteristic of the overall pixel intensity of the subregion).
Regarding claim 19, Kokubo and Connors disclose all of the features in the current invention as shown above in claim 16. They are silent regarding at least one of the first value or the second value is an average value of pixel values of the plurality of pixels included in the heat invasion region.
Fengler teaches a processor that can generate a characteristic of a fluorescence video output by (i) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, (ii) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis and dividing the sum of pixel intensities by the square root of the quantity of fluorescence video frames, (iii) averaging pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, or (iv) a combination thereof ([0033]). Alternatively, other manners that is characteristic of the overall pixel intensity of the subregion or a single individual pixel of a subregion may be used ([0080]). Utilizing a representative pixel intensity for multi-pixel subregions may reduce computational complexity ([0080]).
It would have been obvious to modify the processor to utilize a representative pixel intensity as taught by Fengler ([0033] and [0080]). Doing so would reduce computational complexity ([0080]). The modified processor would comprise at least one of the first value or the second value is an average value of pixel values of the plurality of pixels included in the heat invasion region (averaging pixel intensities…[0033]; Fengler).
Regarding claim 20, Kokubo and Connors disclose all of the features in the current invention as shown above in claim 16. They are silent regarding at least one of the first value or the second value is a maximum value of pixel values of the plurality of pixels included in the heat invasion region.
Fengler teaches a processor that can generate a characteristic of a fluorescence video output by (i) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, (ii) determining a sum of pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis and dividing the sum of pixel intensities by the square root of the quantity of fluorescence video frames, (iii) averaging pixel intensities of the quantity of the fluorescence video frames on a region-by-region basis, or (iv) a combination thereof ([0033]). Alternatively, other manners that is characteristic of the overall pixel intensity of the subregion or a single individual pixel of a subregion may be used ([0080]). Utilizing a representative pixel intensity for multi-pixel subregions may reduce computational complexity ([0080]).
It would have been obvious to modify the processor to utilize a representative pixel intensity as taught by Fengler ([0033] and [0080]). Doing so would reduce computational complexity ([0080]). The modified processor would comprise at least one of the first value or the second value is a maximum value of pixel values of the plurality of pixels included in the heat invasion region (other manner that is characteristic of the overall pixel intensity…a single individual pixel [0080]; Fengler | interpreted a maximum value can be the representative pixel intensity as it can be a characteristic of the overall pixel intensity of the subregion).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kokubo (JP2017023604) and Connors (US 2013/0190742) as applied to claim 1 above, and further in view of Lee (US 2012/0150164).
Regarding claim 8, Kokubo further discloses an endoscope (2, figure 2) configured to pick up an image of a fluorescence emitted from the living body tissue on which a heat treatment is performed by the energy device (fluorescence imaging system…[0025] | cauterization system…[0015]); and a camera (image pickup device 11, figure 2) configured to image, the fluorescence emitted from the living body tissue on which the heat treatment is performed by the energy device ([0025]). They are silent regarding in a visual field range larger than a visual field range of the endoscope.
Lee teaches an imaging system with an excitation source for fluorescent imaging ([0047]). The system has an image detection portion that provides a wide field of view ([0049]).
It would have been obvious to modify the system to have an image detection portion ([0049]) as taught by Lee. Doing so would provide a wide field of view ([0049]). The modified system would have in a visual field range larger than a visual field range of the endoscope (wide field of view [0049]; Lee | interpreted a wide field of view to be larger than a visual field range of the endoscope).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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Claims 1, 3, 6, 8-11, 13, 16, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 11-16, and 21 of Tanigami U.S. Patent No. (US 12,226,082), in view of Kokubo (JP2017023604) and Connors (US 2013/0190742).
Regarding claim 1, Tanigami discloses a medical system comprising: a processor including a memory (claim 1) and being configured to: generate a fluorescence image based on an image pickup signal obtained by imaging a living body tissue irradiated with an excitation light (claim 1); extract a heat invasion region (claim 3) that includes a group of pixels among a plurality of pixels (at least one pixel among a plurality of pixels; claim 1) included in the fluorescence image (claim 1); obtain a first pixel value of the group of pixels (a pixel value; claim 1); obtain a second pixel value of the group of pixels (a pixel value; claim 1); determine whether a second value exceeds a second threshold value (exceeds a first threshold value; claim 1), the second value is regarding the second pixel value; responsive to determining the second value exceeds the second threshold value, output a second control signal configured to stop energy supply to the energy device. Tanigami is silent regarding determine whether a first value exceeds a first threshold value, the first value is regarding the first pixel value; responsive to determining the first value exceeds the first threshold value, output a first control signal configured to decrease energy supply to an energy device; subsequent to outputting the first control signal, obtain the second pixel value of the group of pixels.
Connors teaches a system (100, figure 1) and method for removing tissue using laser ablation ([0028]). The system has a laser source and control system (115, figure 1) that controls the positioning and optical parameters of each of the lasers utilizing the process controller (200, figure 2; [0038]). A detector (170, figure 1), such as a camera system that has image processing functions to detect optical signatures, would produce an output signal related to respective optical signature that would be provided to the laser source and control system ([0048]). In the process controller, iterative measurements are taken of the changes in the necrotic tissue height and position using the detector ([0090] | 230, figure 2). An assessment is made by the process controller as to whether the necrotic tissue is sufficiently ablated (240, figure 2). If no, the position and optical parameters controller (160, figure 1) will adjust the integrated fluence after the determination is made to either decrease, maintain, or increase the fluence and pulse rate (270, 280, and 290, figure 2; [0090]). The decrease in fluence and pulse rate may also include the option for the laser ablation to be terminated ([0090]).
It would have been obvious to modify the system of Tanigami with the laser source and control system (115, figure 1) as taught by Connors. Doing so would provide iterative measurements to control tissue ablation ([0090]). The modified system would have determine whether a first value exceeds a first threshold value (determination…integrated fluence is decreased [0090]; Connors | the modified device would determine if the first value exceeds a threshold value that determines if the fluence needs to be decreased in 260-270, figure 2 of Connors | the modified device would have different threshold values depending on decreasing or stopping energy supply), the first value is regarding the first pixel value; responsive to determining the first value exceeds the first threshold value, output a first control signal configured to decrease energy supply to an energy device (270, figure 2; Connors); subsequent to outputting the first control signal, obtain the second pixel value of the group of pixels (iterative measurements [0090]; Connors).
Regarding claim 3, Tanigami further discloses the first threshold value is smaller than the second threshold value (claim 2 | the modified device would have different threshold values for decreasing vs. stopping energy supply | a higher threshold value can be used for stopping energy supply).
Regarding claim 6, Tanigami further discloses the second value is an average value of the second pixel value of the group of pixels (claim 4).
Regarding claim 8, Tanigami further discloses an endoscope configured to pick up an image of a fluorescence emitted from the living body tissue on which a heat treatment is performed by the energy device (claim 5); and a camera configured to image, in a visual field range larger than a visual field range of the endoscope, the fluorescence emitted from the living body tissue on which the heat treatment is performed by the energy device (claim 5).
Regarding claim 9, Tanigami further discloses a light source is configured to emit in an alternating manner between the excitation light and a white light (claim 6), and wherein the processor is configured to: generate a white light image based on an image pickup signal obtained by imaging the living body tissue irradiated with the white light (claim 6), and cause a display to display a display image including the fluorescence image and the white light image (claim 6).
Regarding claim 10, Tanigami further discloses a light source configured to generate the excitation light (claim 1).
Regarding claim 11, Tanigami further discloses an energy control method comprising: generating a fluorescence image based on an image pickup signal obtained by imaging a living body tissue irradiated with an excitation light (claim 11); extracting a heat invasion region that includes a group of pixels among a plurality of pixels included in the fluorescence image (claims 11-12); obtaining a first pixel value of the group of pixels (a pixel value; claim 11); obtaining a second pixel value of the group of pixels (a pixel value; claim 11); determining whether a second value exceeds a second threshold value (claim 11), the second value is regarding the second pixel value (a pixel value; claim 11); responsive to determining the second value exceeds the second threshold value, outputting a second control signal configured to stop energy supply to the energy device (restrict energy supply; claim 11). Tanigami is silent regarding determining whether a first value exceeds a first threshold value, the first value is regarding the first pixel value; responsive to determining the first value exceeds the first threshold value, outputting a first control signal configured to decrease energy supply to an energy device; subsequent to outputting the first control signal, obtaining the second pixel value of the group of pixels.
Connors teaches a system (100, figure 1) and method for removing tissue using laser ablation ([0028]). The system has a laser source and control system (115, figure 1) that controls the positioning and optical parameters of each of the lasers utilizing the process controller (200, figure 2; [0038]). A detector (170, figure 1), such as a camera system that has image processing functions to detect optical signatures, would produce an output signal related to respective optical signature that would be provided to the laser source and control system ([0048]). In the process controller, iterative measurements are taken of the changes in the necrotic tissue height and position using the detector ([0090] | 230, figure 2). An assessment is made by the process controller as to whether the necrotic tissue is sufficiently ablated (240, figure 2). If no, the position and optical parameters controller (160, figure 1) will adjust the integrated fluence after the determination is made to either decrease, maintain, or increase the fluence and pulse rate (270, 280, and 290, figure 2; [0090]). The decrease in fluence and pulse rate may also include the option for the laser ablation to be terminated ([0090]).
It would have been obvious to modify the method of Tanigami with the laser source and control system (115, figure 1) as taught by Connors. Doing so would provide iterative measurements to control tissue ablation ([0090]). The modified method would comprise determining whether a first value exceeds a first threshold value (determination…integrated fluence is decreased [0090]; Connors | the modified device would determine if the first value exceeds a threshold value that determines if the fluence needs to be decreased in 260-270, figure 2 of Connors | the modified device would have different threshold values depending on decreasing or stopping energy supply), the first value is regarding the first pixel value; responsive to determining the first value exceeds the first threshold value, outputting a first control signal configured to decrease energy supply to an energy device (270, figure 2; Connors); subsequent to outputting the first control signal, obtaining the second pixel value of the group of pixels (iterative measurements [0090]; Connors).
Regarding claim 13, Tanigami further discloses the first threshold value is smaller than a second threshold value (smaller than the first threshold value; claim 12).
Regarding claim 16, Tanigami discloses a processor comprising a processing circuit (claim 13), the processing circuit being configured to: generate a fluorescence image based on an image pickup signal obtained by imaging a living body tissue irradiated with excitation light (claim 13); extract a heat invasion region (claim 15) that includes a group of pixels having a pixel value among a plurality of pixels included in the fluorescence image (pixel value; claims 13-14); determine whether a second value exceeds a second threshold value (pixel value…first threshold value; claim 13), the second value is regarding the pixel value of the group of pixels (claim 13); responsive to determine the second value exceeds the second threshold value, output a second control signal configured to stop energy supply to an energy device (restrict energy supply; claim 13). Tanigami is silent regarding determine whether a first value exceeds a first threshold value, the first value is regarding the pixel value of the group of pixels; responsive to determine the first value exceeds the first threshold value, output a first control signal configured to decrease energy supply to an energy device; subsequent to outputting the first control signal, determine whether the second value exceeds the second threshold value.
Connors teaches a system (100, figure 1) and method for removing tissue using laser ablation ([0028]). The system has a laser source and control system (115, figure 1) that controls the positioning and optical parameters of each of the lasers utilizing the process controller (200, figure 2; [0038]). A detector (170, figure 1), such as a camera system that has image processing functions to detect optical signatures, would produce an output signal related to respective optical signature that would be provided to the laser source and control system ([0048]). In the process controller, iterative measurements are taken of the changes in the necrotic tissue height and position using the detector ([0090] | 230, figure 2). An assessment is made by the process controller as to whether the necrotic tissue is sufficiently ablated (240, figure 2). If no, the position and optical parameters controller (160, figure 1) will adjust the integrated fluence after the determination is made to either decrease, maintain, or increase the fluence and pulse rate (270, 280, and 290, figure 2; [0090]). The decrease in fluence and pulse rate may also include the option for the laser ablation to be terminated ([0090]).
It would have been obvious to modify the processor of Tanigami with the laser source and control system (115, figure 1) as taught by Connors. Doing so would provide iterative measurements to control tissue ablation ([0090]). The modified processor would determine whether a first value exceeds a first threshold value (determination…integrated fluence is decreased [0090]; Connors | the modified device would determine if the first value exceeds a threshold value that determines if the fluence needs to be decreased in 260-270, figure 2 of Connors | the modified device would have different threshold values depending on decreasing or stopping energy supply), the first value is regarding the pixel value of the group of pixels; responsive to determine the first value exceeds the first threshold value, output a first control signal configured to decrease energy supply to an energy device (270, figure 2; Connors); subsequent to outputting the first control signal, determine whether the second value exceeds the second threshold value (iterative measurements [0090]; Connors).
Regarding claim 18, Tanigami further discloses the first threshold value is smaller than a second threshold value (claim 15).
Regarding claim 19, Tanigami further discloses at least one of the first value or the second value is an average value of pixel values of the plurality of pixels included in the heat invasion region (claim 16).
Regarding claim 20, Tanigami further discloses at least one of the first value or the second value is a maximum value of pixel values of the plurality of pixels included in the heat invasion region (claim 21).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Bharat (US 2018/0271577) teaches feedback from imaging may be employed to change ablation parameters ([0062]).
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PAMELA F. WU
Examiner
Art Unit 3795
July 24, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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