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 .
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) 1-8, 11, 14-23, 26, and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gurevich et al. (US 2018/0158187).
Regarding claim 1, Gurevich teaches a computer-implemented method for indicating a stage of movement of a fluorescence imaging agent through tissue, the method comprising, at a computing system (para. 0043; a method 100 for characterizing tissue of a subject may include: receiving a time series of fluorescence images of the tissue of the subject 112, wherein the images define a plurality of calculation regions, generating a plurality of time-intensity curves for the plurality of calculation regions 114, creating a set of parameter values for each calculation region 116, wherein the parameter values approximate at least a portion of the time-intensity curve, generating a total rank value for each calculation region by comparing the sets of parameter values for the plurality of calculation regions 118, and converting the total rank values for the calculation region into a ranking map image 120.):
receiving a plurality of fluorescence imaging frames capturing a fluorescence imaging agent moving through tissue (para. 0043; a method 100 for characterizing tissue of a subject may include: receiving a time series of fluorescence images of the tissue of the subject 112, wherein the images define a plurality of calculation regions);
determining a stage of movement of the fluorescence imaging agent through the tissue as the fluorescence imaging agent moves through the tissue (paras. 0067-0070; generating a plurality of time-intensity curves for the plurality of calculation regions, a time-intensity curve 212 comprises a region of increasing intensity, a region of peak intensity, a plateau region, a region of decreasing intensity, or a combination thereof. In the context of fluorescence imaging (e.g., fluorescence angiography), as shown in FIG. 3, a time-intensity curve 312 may represent the transit of a fluorescence imaging agent (e.g., a fluorescence dye) bolus through the tissue as a series of phases: an arterial phase, a micro-vascular phase, a venous phase, a residual phase, or a combination thereof. the method includes creating a set of parameter values for each calculation region 116, wherein the parameter values characterize or approximate at least a portion of the time-intensity curve. In some variations, one or more of the parameter types may be defined with respect to time properties of the curve. For example, one or more of the parameter types may be related to duration of a particular region of the time-intensity curve, such as: (i) the duration of a region of increasing intensity of the time-intensity curve, (ii) the duration of a region of peak or high intensity of the time-intensity curve, (iii) the duration of a region of a plateau of the time-intensity curve, or (iv) the duration of a region of decreasing intensity of the time-intensity curve. In the context of fluorescence imaging (e.g., fluorescence angiography), one or more of the parameter types may be related to the duration of a perfusion onset phase, an arterial phase, a micro-vascular phase, or venous phase. As another example, one or more of the parameter types may be related to a defined period of elapsed time, between one defined event (e.g. the beginning of the raw or pre-processed time series of fluorescence images) and a second defined event, such as: (v) the time to the onset of increasing fluorescence intensity. As another example, one or more of the parameter types may be related to a defined period of time with key rate-of-change or other intensity characteristics, such as: (vi) the time for rapid or most rapid fluorescence intensity increase, the time for rapid or most rapid fluorescence intensity decrease, and/or rate of change in fluorescence intensity for any of the above-described regions of the time-intensity curve. The examiner notes that the system determines the stage of movement of the fluorescence agent by generating a time intensity curves of the fluorescence imaging frames. The system uses the curves to define the stage of movement of the fluorescence agent through the tissue.); and
providing an indication to a user, as the fluorescence imaging agent moves through the tissue, that indicates the stage of movement of the fluorescence imaging agent through the tissue (paras. 0083-0086; converting the total rank values into a ranking map image 120. The resulting ranking map image visualizes the spatial distribution of total rank values across the calculation regions, and thereby visualizes any relative differences in total rank values among the calculation regions. converting the total rank values into a ranking map image 120 may include correlating each total rank value to an intensity value, such that the calculation regions in the ranking map image may be depicted with varying intensity values corresponding to total rank values. The conversion may involve assigning a display brightness value to each total rank value wherein the total rank value and brightness value are in a direct relationship (e.g., the higher the rank, the higher the pixel's intensity). The direct relationship may be linear or nonlinear. In other variations, the conversion may be based on an indirect relationship between the total rank value and brightness value. the method may further include displaying the ranking map image on a display 122. For example, the ranking map image may be displayed within a user interface on a video monitor in a fluorescence imaging system, or other suitable display. The examiner notes that using the parameters assigned to each region of the time intensity curve to compare it with other regions to generate a total rank value for each calculation region in the time series of images. Generating a total rank value for each calculation region results in a quantitative description of how the time-intensity curve for each calculation region compares to the time-intensity curves of other calculation regions. Then, the system generates a rank map to visualize and indicate the stage of movement of the fluorescent agent.).
Regarding claim 2, Gurevich teaches the computer-implemented method of claim 1, comprising: determining that the stage of movement of the fluorescence imaging agent through the tissue is suitable for performing an assessment related to blood flow (paras. 0083 and 0099; the method includes converting the total rank values into a ranking map image 120. The resulting ranking map image visualizes the spatial distribution of total rank values across the calculation regions, and thereby visualizes any relative differences in total rank values among the calculation regions. Thus, the ranking map image shows any relative differences among different parts of the imaged tissue with respect to the selected parameters, which highlights different properties (e.g., physiological properties) of the tissue in an objective, easily understood manner. As further described above, as a result, the ranking map image may facilitate more effective, consistent clinical assessments and decision-making. Modulating at least a portion of the total rank values enhances or exaggerates the differences between total rank values corresponding to the wound regions of the target tissue and total rank values corresponding to the non-wound regions of the target tissue and other areas of less interest. In other words, modulating at least some of the total rank values facilitates selection of the data of interest (e.g., data arising from the wound in the target tissue) from other data (e.g., data not arising from the wound region in the target tissue and/or data associated with background). The examiner notes that the total rank value is compared to a reference value and a modified ranking map is used to select based on the rank, a region suitable for performing a wound assessment. The region represents the stage of movement of the fluorescent agent.) ; and
providing an indication to the user, as the fluorescence imaging agent moves through the tissue, that the stage of movement of the fluorescence imaging agent through the tissue is suitable for performing the assessment related to blood flow (paras. 0102 and 0110-0111; the modified total rank values may be converted into a modified ranking map image. For example, each of the modified total rank values may be correlated to an intensity value, such that the calculation regions in the modified ranking map image may be depicted with varying intensity values corresponding to the modified total rank values. In such a modified ranking map image, modified total rank values corresponding to wounded regions will appear significantly different from modified total rank values corresponding to non-wounded regions, due to the numerical distance between them following modulation. This modified ranking map image may be displayed, such as on video monitor in an imaging system or other suitable display. the method 400 also includes generating a wound index value 428 based on at least a portion of the data set of modified total rank values. In some variations, this wound index value is generally a single, numerical value. In some variations, the wound index value is based on an average of the wound characterization values. For example, generating a wound index value may include summing the modified rank values corresponding to calculation regions located in the wound, and dividing the sum by the total number of pixels in the image (i.e., averaging over the entire image). The generated wound index value provides a quantitative representation of the wound. As a result, the wound index value provides for an objective, standardized protocol for assessing tissue blood flow and/or tissue perfusion, which may facilitate a way to reliably and consistently compare and track blood flow and/or perfusion status of a patient over time across multiple imaging sessions, regardless of the clinician performing the assessment. The examiner notes that after identifying the area of the wound using the suitable stage of movement of the fluorescent agent, the system generates a wound index value relative to the identified stage as an indication for a suitable region for performing blood flow assessment).
Regarding claim 3, Gurevich teaches the computer-implemented method of claim 1, comprising: determining that the stage of movement of the fluorescence imaging agent through the tissue is not suitable for performing an assessment related to blood flow (para. 0062; Accordingly, the time series of fluorescence images subjected to such a test might fail the validation procedure (be identified as being unsuitable for further processing). According to an exemplary embodiment, the brightness change test comprises a calculation of the difference between average intensities of neighboring frames in the time series of fluorescence images and compares it to a selected intensity difference threshold. In order to pass validation, the differences in intensities of all consecutive frames must be within the limit specified by the selected intensity difference threshold.); and providing an indication to the user, as the fluorescence imaging agent moves through the tissue, that the stage of movement of the fluorescence imaging agent through the tissue is not suitable for performing the assessment related to blood flow (para. 0062; Accordingly, the time series of fluorescence images subjected to such a test might fail the validation procedure (be identified as being unsuitable for further processing). According to an exemplary embodiment, the brightness change test comprises a calculation of the difference between average intensities of neighboring frames in the time series of fluorescence images and compares it to a selected intensity difference threshold. In order to pass validation, the differences in intensities of all consecutive frames must be within the limit specified by the selected intensity difference threshold.).
Regarding claim 4, Gurevich teaches the computer-implemented method of claim 1, wherein determining the stage of movement of the fluorescence imaging agent through the tissue comprises: determining one or more characteristics of a fluorescence imaging signal of the fluorescence imaging agent moving through the tissue (paras. 0068-0070; the method includes creating a set of parameter values for each calculation region 116, wherein the parameter values characterize or approximate at least a portion of the time-intensity curve. In some variations, one or more of the parameter types may be defined with respect to time properties of the curve. For example, one or more of the parameter types may be related to duration of a particular region of the time-intensity curve, such as: (i) the duration of a region of increasing intensity of the time-intensity curve, (ii) the duration of a region of peak or high intensity of the time-intensity curve, (iii) the duration of a region of a plateau of the time-intensity curve, or (iv) the duration of a region of decreasing intensity of the time-intensity curve. In the context of fluorescence imaging (e.g., fluorescence angiography), one or more of the parameter types may be related to the duration of a perfusion onset phase, an arterial phase, a micro-vascular phase, or venous phase. As another example, one or more of the parameter types may be related to a defined period of elapsed time, between one defined event (e.g. the beginning of the raw or pre-processed time series of fluorescence images) and a second defined event, such as: (v) the time to the onset of increasing fluorescence intensity. As another example, one or more of the parameter types may be related to a defined period of time with key rate-of-change or other intensity characteristics, such as: (vi) the time for rapid or most rapid fluorescence intensity increase, the time for rapid or most rapid fluorescence intensity decrease, and/or rate of change in fluorescence intensity for any of the above-described regions of the time-intensity curve.); and comparing the one or more characteristics to predefined criteria (para. 0088; receiving a time series of fluorescence images of the target tissue region of the subject 412, wherein the images define a plurality of calculation regions, generating a plurality of time-intensity curves for the plurality of calculation regions 414, creating one or more parameter values for each calculation region 416, wherein the one or more parameter values approximates at least a portion of the time-intensity curve, generating a total rank value for each calculation region by comparing the sets of parameter values for the plurality of calculation regions 418, generating a data set comprising modified total rank values 426, wherein the modified total rank values are based at least in part on a comparison between the total rank values and a reference value, and generating a wound index value 428 based on at least a portion of the data set corresponding to calculation regions located in the wound.).
Regarding claim 5, Gurevich teaches the computer-implemented method of claim 4, wherein the one or more characteristics of the fluorescence imaging signal comprises a rate of change in fluorescence intensity of the fluorescence imaging signal (para. 0070; As another example, one or more of the parameter types may be related to a defined period of time with key rate-of-change or other intensity characteristics, such as: (vi) the time for rapid or most rapid fluorescence intensity increase, the time for rapid or most rapid fluorescence intensity decrease, and/or rate of change in fluorescence intensity for any of the above-described regions of the time-intensity curve.).
Regarding claim 6, Gurevich teaches the computer-implemented method of claim 1, wherein the indication comprises a graphical indication of the stage of movement of the fluorescence imaging agent on a display (fig. 3, para. 0085; the total rank value may be mapped to a gray scale or a color scale value. For example, the total rank values may be mapped to an 8-bit grayscale display value (e.g., from 0 to 255), allowing for a grayscale image representation of the total rank values. In some variations, to optimize visual perception, a color scheme can be applied to the grayscale image representation with different grayscale value ranges represented in appropriately contrasting colors (such as a false color or pseudo color). Other scales may additionally or alternatively be applied to convert the total rank values into pixel values for the spatial ranking map image, such that the differences in pixel values reflect the relative differences in total rank values and among different regions of the imaged tissue.).
Regarding claim 7, Gurevich teaches the computer-implemented method of claim 6, wherein the graphical indication comprises a graphed curve representing a fluorescence intensity signal of the fluorescence imaging agent over time, as the fluorescence imaging agent moves through the tissue (fig. 3, paras. 0068 and 0075; as shown in FIG. 3, a time-intensity curve 312 may represent the transit of a fluorescence imaging agent (e.g., a fluorescence dye) bolus through the tissue as a series of phases: an arterial phase, a micro-vascular phase, a venous phase, a residual phase, or a combination thereof).
Regarding claim 8, Gurevich teaches the computer-implemented method of claim 7, comprising updating the graphed curve in a stepwise fashion over time, as the fluorescence imaging agent moves through the tissue (fig. 3, paras. 0068 and 0075; as shown in FIG. 3, a time-intensity curve 312 may represent the transit of a fluorescence imaging agent (e.g., a fluorescence dye) bolus through the tissue as a series of phases: an arterial phase, a micro-vascular phase, a venous phase, a residual phase, or a combination thereof. The examiner notes that the time intensity curve updates its representation and shape based on time dependent images received.).
Regarding claim 11, Gurevich teaches the computer-implemented method of claim 6, wherein the graphical indication comprises a first graphical indicator corresponding to a first stage of movement of the fluorescence imaging agent, and a second graphical indicator corresponding to a second stage of movement of the fluorescence imaging agent (fig. 3, the examiner notes that the time intensity curve is annotated using the parameters representing the stage of movement of the fluorescent agent through the tissue. Such as a region of rapid increase, a region of rapid decrease, an ingress region, etc.).
Regarding claim 14, Gurevich teaches the computer-implemented method of claim 1, wherein the stage of movement is one of at least three stages of movement of the fluorescence imaging agent through the tissue (paras. 0068-0070 and 0075; a time-intensity curve 212 comprises a region of increasing intensity, a region of peak intensity, a plateau region, a region of decreasing intensity, or a combination thereof.).
Regarding claim 15, Gurevich teaches the computer-implemented method of claim 14, wherein the at least three stages of movement of the fluorescence imaging agent through the tissue comprises an ingress stage, an egress stage, and a peak stage for performing an assessment related to blood flow (para. 0070; the method includes creating a set of parameter values for each calculation region 116, wherein the parameter values characterize or approximate at least a portion of the time-intensity curve. In some variations, one or more of the parameter types may be defined with respect to time properties of the curve. For example, one or more of the parameter types may be related to duration of a particular region of the time-intensity curve, such as: (i) the duration of a region of increasing intensity of the time-intensity curve, (ii) the duration of a region of peak or high intensity of the time-intensity curve, (iii) the duration of a region of a plateau of the time-intensity curve, or (iv) the duration of a region of decreasing intensity of the time-intensity curve. In the context of fluorescence imaging (e.g., fluorescence angiography), one or more of the parameter types may be related to the duration of a perfusion onset phase, an arterial phase, a micro-vascular phase, or venous phase.).
Regarding claim 16, Gurevich teaches a system for indicating a stage of movement of a fluorescence imaging agent through tissue, the system comprising a display and one or more processors configured to cause the system to (paras. 0043 and 0045; at least a portion of the method is performed by one or more processors at a computer system incorporated into a medical imaging system, such as at a clinical site. For example, some or all of the steps of receiving a time series of fluorescence images 112, generating a plurality of time-intensity curves 114, creating a set of parameter values 116, generating a total rank value for each calculation region 118, and converting the total rank values into a ranking map image 120 may be performed by a computer system in a medical imaging system. In some of these variations, the method may further include generating the time series of fluorescence images 110 prior to receiving the time series of fluorescence images.):
receive a plurality of fluorescence imaging frames capturing a fluorescence imaging agent moving through tissue (para. 0043; a method 100 for characterizing tissue of a subject may include: receiving a time series of fluorescence images of the tissue of the subject 112, wherein the images define a plurality of calculation regions);
determine a stage of movement of the fluorescence imaging agent through the tissue as the fluorescence imaging agent moves through the tissue (paras. 0067-0070; generating a plurality of time-intensity curves for the plurality of calculation regions, a time-intensity curve 212 comprises a region of increasing intensity, a region of peak intensity, a plateau region, a region of decreasing intensity, or a combination thereof. In the context of fluorescence imaging (e.g., fluorescence angiography), as shown in FIG. 3, a time-intensity curve 312 may represent the transit of a fluorescence imaging agent (e.g., a fluorescence dye) bolus through the tissue as a series of phases: an arterial phase, a micro-vascular phase, a venous phase, a residual phase, or a combination thereof. the method includes creating a set of parameter values for each calculation region 116, wherein the parameter values characterize or approximate at least a portion of the time-intensity curve. In some variations, one or more of the parameter types may be defined with respect to time properties of the curve. For example, one or more of the parameter types may be related to duration of a particular region of the time-intensity curve, such as: (i) the duration of a region of increasing intensity of the time-intensity curve, (ii) the duration of a region of peak or high intensity of the time-intensity curve, (iii) the duration of a region of a plateau of the time-intensity curve, or (iv) the duration of a region of decreasing intensity of the time-intensity curve. In the context of fluorescence imaging (e.g., fluorescence angiography), one or more of the parameter types may be related to the duration of a perfusion onset phase, an arterial phase, a micro-vascular phase, or venous phase. As another example, one or more of the parameter types may be related to a defined period of elapsed time, between one defined event (e.g. the beginning of the raw or pre-processed time series of fluorescence images) and a second defined event, such as: (v) the time to the onset of increasing fluorescence intensity. As another example, one or more of the parameter types may be related to a defined period of time with key rate-of-change or other intensity characteristics, such as: (vi) the time for rapid or most rapid fluorescence intensity increase, the time for rapid or most rapid fluorescence intensity decrease, and/or rate of change in fluorescence intensity for any of the above-described regions of the time-intensity curve. The examiner notes that the system determines the stage of movement of the fluorescence agent by generating a time intensity curves of the fluorescence imaging frames. The system uses the curves to define the stage of movement of the fluorescence agent through the tissue.); and
provide an indication to a user, as the fluorescence imaging agent moves through the tissue, that indicates the stage of movement of the fluorescence imaging agent through the tissue (paras. 0083-0086; converting the total rank values into a ranking map image 120. The resulting ranking map image visualizes the spatial distribution of total rank values across the calculation regions, and thereby visualizes any relative differences in total rank values among the calculation regions. converting the total rank values into a ranking map image 120 may include correlating each total rank value to an intensity value, such that the calculation regions in the ranking map image may be depicted with varying intensity values corresponding to total rank values. The conversion may involve assigning a display brightness value to each total rank value wherein the total rank value and brightness value are in a direct relationship (e.g., the higher the rank, the higher the pixel's intensity). The direct relationship may be linear or nonlinear. In other variations, the conversion may be based on an indirect relationship between the total rank value and brightness value. the method may further include displaying the ranking map image on a display 122. For example, the ranking map image may be displayed within a user interface on a video monitor in a fluorescence imaging system, or other suitable display. The examiner notes that using the parameters assigned to each region of the time intensity curve to compare it with other regions to generate a total rank value for each calculation region in the time series of images. Generating a total rank value for each calculation region results in a quantitative description of how the time-intensity curve for each calculation region compares to the time-intensity curves of other calculation regions. Then, the system generates a rank map to visualize and indicate the stage of movement of the fluorescent agent.).
Regarding claim 17, Gurevich teaches the system of claim 16, wherein the one or more processors are configured to cause the system to: determine that the stage of movement of the fluorescence imaging agent through the tissue is suitable for performing an assessment related to blood flow (paras. 0083 and 0099; the method includes converting the total rank values into a ranking map image 120. The resulting ranking map image visualizes the spatial distribution of total rank values across the calculation regions, and thereby visualizes any relative differences in total rank values among the calculation regions. Thus, the ranking map image shows any relative differences among different parts of the imaged tissue with respect to the selected parameters, which highlights different properties (e.g., physiological properties) of the tissue in an objective, easily understood manner. As further described above, as a result, the ranking map image may facilitate more effective, consistent clinical assessments and decision-making. Modulating at least a portion of the total rank values enhances or exaggerates the differences between total rank values corresponding to the wound regions of the target tissue and total rank values corresponding to the non-wound regions of the target tissue and other areas of less interest. In other words, modulating at least some of the total rank values facilitates selection of the data of interest (e.g., data arising from the wound in the target tissue) from other data (e.g., data not arising from the wound region in the target tissue and/or data associated with background). The examiner notes that the total rank value is compared to a reference value and a modified ranking map is used to select based on the rank, a region suitable for performing a wound assessment. The region represents the stage of movement of the fluorescent agent.) ; and
provide an indication to the user, as the fluorescence imaging agent moves through the tissue, that the stage of movement of the fluorescence imaging agent through the tissue is suitable for performing the assessment related to blood flow (paras. 0102 and 0110-0111; the modified total rank values may be converted into a modified ranking map image. For example, each of the modified total rank values may be correlated to an intensity value, such that the calculation regions in the modified ranking map image may be depicted with varying intensity values corresponding to the modified total rank values. In such a modified ranking map image, modified total rank values corresponding to wounded regions will appear significantly different from modified total rank values corresponding to non-wounded regions, due to the numerical distance between them following modulation. This modified ranking map image may be displayed, such as on video monitor in an imaging system or other suitable display. the method 400 also includes generating a wound index value 428 based on at least a portion of the data set of modified total rank values. In some variations, this wound index value is generally a single, numerical value. In some variations, the wound index value is based on an average of the wound characterization values. For example, generating a wound index value may include summing the modified rank values corresponding to calculation regions located in the wound, and dividing the sum by the total number of pixels in the image (i.e., averaging over the entire image). The generated wound index value provides a quantitative representation of the wound. As a result, the wound index value provides for an objective, standardized protocol for assessing tissue blood flow and/or tissue perfusion, which may facilitate a way to reliably and consistently compare and track blood flow and/or perfusion status of a patient over time across multiple imaging sessions, regardless of the clinician performing the assessment. The examiner notes that after identifying the area of the wound using the suitable stage of movement of the fluorescent agent, the system generates a wound index value relative to the identified stage as an indication for a suitable region for performing blood flow assessment).
Regarding claim 18, Gurevich teaches system of claim 16, wherein the one or more processors are configured to cause the system to: determine that the stage of movement of the fluorescence imaging agent through the tissue is not suitable for performing an assessment related to blood flow (para. 0062; Accordingly, the time series of fluorescence images subjected to such a test might fail the validation procedure (be identified as being unsuitable for further processing). According to an exemplary embodiment, the brightness change test comprises a calculation of the difference between average intensities of neighboring frames in the time series of fluorescence images and compares it to a selected intensity difference threshold. In order to pass validation, the differences in intensities of all consecutive frames must be within the limit specified by the selected intensity difference threshold.); and provide an indication to the user, as the fluorescence imaging agent moves through the tissue, that the stage of movement of the fluorescence imaging agent through the tissue is not suitable for performing the assessment related to blood flow (para. 0062; Accordingly, the time series of fluorescence images subjected to such a test might fail the validation procedure (be identified as being unsuitable for further processing). According to an exemplary embodiment, the brightness change test comprises a calculation of the difference between average intensities of neighboring frames in the time series of fluorescence images and compares it to a selected intensity difference threshold. In order to pass validation, the differences in intensities of all consecutive frames must be within the limit specified by the selected intensity difference threshold.).
Regarding claim 19, Gurevich teaches the system of claim 16, wherein determining the stage of movement of the fluorescence imaging agent through the tissue comprises: determining one or more characteristics of a fluorescence imaging signal of the fluorescence imaging agent moving through the tissue (paras. 0068-0070; the method includes creating a set of parameter values for each calculation region 116, wherein the parameter values characterize or approximate at least a portion of the time-intensity curve. In some variations, one or more of the parameter types may be defined with respect to time properties of the curve. For example, one or more of the parameter types may be related to duration of a particular region of the time-intensity curve, such as: (i) the duration of a region of increasing intensity of the time-intensity curve, (ii) the duration of a region of peak or high intensity of the time-intensity curve, (iii) the duration of a region of a plateau of the time-intensity curve, or (iv) the duration of a region of decreasing intensity of the time-intensity curve. In the context of fluorescence imaging (e.g., fluorescence angiography), one or more of the parameter types may be related to the duration of a perfusion onset phase, an arterial phase, a micro-vascular phase, or venous phase. As another example, one or more of the parameter types may be related to a defined period of elapsed time, between one defined event (e.g. the beginning of the raw or pre-processed time series of fluorescence images) and a second defined event, such as: (v) the time to the onset of increasing fluorescence intensity. As another example, one or more of the parameter types may be related to a defined period of time with key rate-of-change or other intensity characteristics, such as: (vi) the time for rapid or most rapid fluorescence intensity increase, the time for rapid or most rapid fluorescence intensity decrease, and/or rate of change in fluorescence intensity for any of the above-described regions of the time-intensity curve.); and comparing the one or more characteristics to predefined criteria (para. 0088; receiving a time series of fluorescence images of the target tissue region of the subject 412, wherein the images define a plurality of calculation regions, generating a plurality of time-intensity curves for the plurality of calculation regions 414, creating one or more parameter values for each calculation region 416, wherein the one or more parameter values approximates at least a portion of the time-intensity curve, generating a total rank value for each calculation region by comparing the sets of parameter values for the plurality of calculation regions 418, generating a data set comprising modified total rank values 426, wherein the modified total rank values are based at least in part on a comparison between the total rank values and a reference value, and generating a wound index value 428 based on at least a portion of the data set corresponding to calculation regions located in the wound.).
Regarding claim 20, Gurevich teaches the system of claim 19, wherein the one or more characteristics of the fluorescence imaging signal comprises a rate of change in fluorescence intensity of the fluorescence imaging signal (para. 0070; As another example, one or more of the parameter types may be related to a defined period of time with key rate-of-change or other intensity characteristics, such as: (vi) the time for rapid or most rapid fluorescence intensity increase, the time for rapid or most rapid fluorescence intensity decrease, and/or rate of change in fluorescence intensity for any of the above-described regions of the time-intensity curve.).
Regarding claim 21, Gurevich teaches the system of claim 16, wherein the indication comprises a graphical indication of the stage of movement of the fluorescence imaging agent on a display (fig. 3, para. 0085; the total rank value may be mapped to a gray scale or a color scale value. For example, the total rank values may be mapped to an 8-bit grayscale display value (e.g., from 0 to 255), allowing for a grayscale image representation of the total rank values. In some variations, to optimize visual perception, a color scheme can be applied to the grayscale image representation with different grayscale value ranges represented in appropriately contrasting colors (such as a false color or pseudo color). Other scales may additionally or alternatively be applied to convert the total rank values into pixel values for the spatial ranking map image, such that the differences in pixel values reflect the relative differences in total rank values and among different regions of the imaged tissue.).
Regarding claim 22, Gurevich teaches the system of claim 21, wherein the graphical indication comprises a graphed curve representing a fluorescence intensity signal of the fluorescence imaging agent over time, as the fluorescence imaging agent moves through the tissue (fig. 3, paras. 0068 and 0075; as shown in FIG. 3, a time-intensity curve 312 may represent the transit of a fluorescence imaging agent (e.g., a fluorescence dye) bolus through the tissue as a series of phases: an arterial phase, a micro-vascular phase, a venous phase, a residual phase, or a combination thereof).
Regarding claim 23, Gurevich teaches the system of claim 22, comprising updating the graphed curve in a stepwise fashion over time, as the fluorescence imaging agent moves through the tissue (fig. 3, paras. 0068 and 0075; as shown in FIG. 3, a time-intensity curve 312 may represent the transit of a fluorescence imaging agent (e.g., a fluorescence dye) bolus through the tissue as a series of phases: an arterial phase, a micro-vascular phase, a venous phase, a residual phase, or a combination thereof. The examiner notes that the time intensity curve updates its representation and shape based on time dependent images received.).
Regarding claim 26, Gurevich teaches the system of claim 21, wherein the graphical indication comprises a first graphical indicator corresponding to a first stage of movement of the fluorescence imaging agent, and a second graphical indicator corresponding to a second stage of movement of the fluorescence imaging agent (fig. 3, the examiner notes that the time intensity curve is annotated using the parameters representing the stage of movement of the fluorescent agent through the tissue. Such as a region of rapid increase, a region of rapid decrease, an ingress region, etc.).
Regarding claim 29, Gurevich teaches the system of claim 16, wherein the stage of movement is one of at least three stages of movement of the fluorescence imaging agent through the tissue (paras. 0068-0070 and 0075; a time-intensity curve 212 comprises a region of increasing intensity, a region of peak intensity, a plateau region, a region of decreasing intensity, or a combination thereof.).
Regarding claim 30, Gurevich teaches the system of claim 29, wherein the at least three stages of movement of the fluorescence imaging agent through the tissue comprises an ingress stage, an egress stage, and a peak stage for performing an assessment related to blood flow (para. 0070; the method includes creating a set of parameter values for each calculation region 116, wherein the parameter values characterize or approximate at least a portion of the time-intensity curve. In some variations, one or more of the parameter types may be defined with respect to time properties of the curve. For example, one or more of the parameter types may be related to duration of a particular region of the time-intensity curve, such as: (i) the duration of a region of increasing intensity of the time-intensity curve, (ii) the duration of a region of peak or high intensity of the time-intensity curve, (iii) the duration of a region of a plateau of the time-intensity curve, or (iv) the duration of a region of decreasing intensity of the time-intensity curve. In the context of fluorescence imaging (e.g., fluorescence angiography), one or more of the parameter types may be related to the duration of a perfusion onset phase, an arterial phase, a micro-vascular phase, or venous phase.).
Regarding claim 31, Gurevich teaches a non-transitory computer-readable storage medium storing instructions for indicating a stage of movement of a fluorescence imaging agent through tissue, the instructions executable by a system comprising a display and one or more processors, wherein execution of the instructions by the system causes the system to (paras. 0043 and 0045; at least a portion of the method is performed by one or more processors at a computer system incorporated into a medical imaging system, such as at a clinical site. For example, some or all of the steps of receiving a time series of fluorescence images 112, generating a plurality of time-intensity curves 114, creating a set of parameter values 116, generating a total rank value for each calculation region 118, and converting the total rank values into a ranking map image 120 may be performed by a computer system in a medical imaging system. In some of these variations, the method may further include generating the time series of fluorescence images 110 prior to receiving the time series of fluorescence images.):
receive a plurality of fluorescence imaging frames capturing a fluorescence imaging agent moving through tissue (para. 0043; a method 100 for characterizing tissue of a subject may include: receiving a time series of fluorescence images of the tissue of the subject 112, wherein the images define a plurality of calculation regions);
determine a stage of movement of the fluorescence imaging agent through the tissue as the fluorescence imaging agent moves through the tissue (paras. 0067-0070; generating a plurality of time-intensity curves for the plurality of calculation regions, a time-intensity curve 212 comprises a region of increasing intensity, a region of peak intensity, a plateau region, a region of decreasing intensity, or a combination thereof. In the context of fluorescence imaging (e.g., fluorescence angiography), as shown in FIG. 3, a time-intensity curve 312 may represent the transit of a fluorescence imaging agent (e.g., a fluorescence dye) bolus through the tissue as a series of phases: an arterial phase, a micro-vascular phase, a venous phase, a residual phase, or a combination thereof. the method includes creating a set of parameter values for each calculation region 116, wherein the parameter values characterize or approximate at least a portion of the time-intensity curve. In some variations, one or more of the parameter types may be defined with respect to time properties of the curve. For example, one or more of the parameter types may be related to duration of a particular region of the time-intensity curve, such as: (i) the duration of a region of increasing intensity of the time-intensity curve, (ii) the duration of a region of peak or high intensity of the time-intensity curve, (iii) the duration of a region of a plateau of the time-intensity curve, or (iv) the duration of a region of decreasing intensity of the time-intensity curve. In the context of fluorescence imaging (e.g., fluorescence angiography), one or more of the parameter types may be related to the duration of a perfusion onset phase, an arterial phase, a micro-vascular phase, or venous phase. As another example, one or more of the parameter types may be related to a defined period of elapsed time, between one defined event (e.g. the beginning of the raw or pre-processed time series of fluorescence images) and a second defined event, such as: (v) the time to the onset of increasing fluorescence intensity. As another example, one or more of the parameter types may be related to a defined period of time with key rate-of-change or other intensity characteristics, such as: (vi) the time for rapid or most rapid fluorescence intensity increase, the time for rapid or most rapid fluorescence intensity decrease, and/or rate of change in fluorescence intensity for any of the above-described regions of the time-intensity curve. The examiner notes that the system determines the stage of movement of the fluorescence agent by generating a time intensity curves of the fluorescence imaging frames. The system uses the curves to define the stage of movement of the fluorescence agent through the tissue.); and
provide an indication to a user, as the fluorescence imaging agent moves through the tissue, that indicates the stage of movement of the fluorescence imaging agent through the tissue (paras. 0083-0086; converting the total rank values into a ranking map image 120. The resulting ranking map image visualizes the spatial distribution of total rank values across the calculation regions, and thereby visualizes any relative differences in total rank values among the calculation regions. converting the total rank values into a ranking map image 120 may include correlating each total rank value to an intensity value, such that the calculation regions in the ranking map image may be depicted with varying intensity values corresponding to total rank values. The conversion may involve assigning a display brightness value to each total rank value wherein the total rank value and brightness value are in a direct relationship (e.g., the higher the rank, the higher the pixel's intensity). The direct relationship may be linear or nonlinear. In other variations, the conversion may be based on an indirect relationship between the total rank value and brightness value. the method may further include displaying the ranking map image on a display 122. For example, the ranking map image may be displayed within a user interface on a video monitor in a fluorescence imaging system, or other suitable display. The examiner notes that using the parameters assigned to each region of the time intensity curve to compare it with other regions to generate a total rank value for each calculation region in the time series of images. Generating a total rank value for each calculation region results in a quantitative description of how the time-intensity curve for each calculation region compares to the time-intensity curves of other calculation regions. Then, the system generates a rank map to visualize and indicate the stage of movement of the fluorescent agent.).
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(s) 13 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Gurevich et al. (US 2018/0158187) in the view of Yoshizaki et al. (US 2017/0360275).
Regarding claim 13, Gurevich teaches the computer-implemented method of claim 1, however fails to explicitly teach wherein the indication comprises an audio alert.
Yoshizaki, in the same field of endeavor, teaches the indication comprises an audio alert (para. 0064; The output unit 65 outputs, under the control of the control unit 66, a message that the fluorescent agent administered to the subject is in a steady state. The output unit 65 is formed by using: a speaker adapted to output sound; a display panel such as a liquid crystal and an organic EL capable of displaying characters; an LED lamp and the like which can be turned on or blinked and emits light to the outside.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the output of Gurevich to incorporate the teaching of Yoshizaki to include an audio alert output. Doing so would help the user to easily grasp that the fluorescence of the fluorescent agent is in the steady state as disclosed within Yoshizaki in para. 0092.
Regarding claim 28, Gurevich teaches the system of claim 16, however fails to explicitly teach wherein the indication comprises an audio alert.
Yoshizaki, in the same field of endeavor, teaches the indication comprises an audio alert (para. 0064; The output unit 65 outputs, under the control of the control unit 66, a message that the fluorescent agent administered to the subject is in a steady state. The output unit 65 is formed by using: a speaker adapted to output sound; a display panel such as a liquid crystal and an organic EL capable of displaying characters; an LED lamp and the like which can be turned on or blinked and emits light to the outside.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the output of Gurevich to incorporate the teaching of Yoshizaki to include an audio alert output. Doing so would help the user to easily grasp that the fluorescence of the fluorescent agent is in the steady state as disclosed within Yoshizaki in para. 0092.
Allowable Subject Matter
Claims 9-10, 12, 24-25, and 27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: none of the prior art cited in the office action teach or suggest outputting a graphical indication comprises a meter having (a) a plurality of regions corresponding to stages of movement of the fluorescence imaging agent through the tissue, and (b) a needle that moves between the plurality of regions to indicate the stage of movement of the fluorescence imaging agent as the fluorescence imaging agent moves through the tissue and adjusting a position of the needle within a region of the plurality of regions of the meter, as the fluorescence imaging agent moves through the tissue, based on at least one characteristic of a fluorescence intensity signal of the fluorescence imaging agent; providing the second graphical indicator to the user in place of the first graphical indicator.
Gurevich, teach displaying a time intensity curve with different parameters assigned and ranked based on the stage of the movement of the fluorescent agent. However, Gurevich fails to teach providing a graphical indication comprising a meter having (a) a plurality of regions corresponding to stages of movement of the fluorescence imaging agent through the tissue, and (b) a needle that moves between the plurality of regions to indicate the stage of movement of the fluorescence imaging agent as the fluorescence imaging agent moves through the tissue and adjusting a position of the needle within a region of the plurality of regions of the meter, as the fluorescence imaging agent moves through the tissue, based on at least one characteristic of a fluorescence intensity signal of the fluorescence imaging agent.
Yoshizaki, teaches displaying a text or audio message to the user notifying the user of the fluorescence agent reaching a steady state stage. However, fails to teach providing a graphical indication comprising a meter having (a) a plurality of regions corresponding to stages of movement of the fluorescence imaging agent through the tissue, and (b) a needle that moves between the plurality of regions to indicate the stage of movement of the fluorescence imaging agent as the fluorescence imaging agent moves through the tissue and adjusting a position of the needle within a region of the plurality of regions of the meter, as the fluorescence imaging agent moves through the tissue, based on at least one characteristic of a fluorescence intensity signal of the fluorescence imaging agent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797
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