DETAILED ACTION
The United States Patent & Trademark Office appreciates the response filed for the current application that is submitted on 03/16/2026. The United States Patent & Trademark Office reviewed the following documents submitted and has made the following comments below.
Amendment
Applicant submitted amendments on 03/16/2026. The Examiner acknowledges the amendment and has reviewed the claims accordingly.
Information Disclosure Statement
The IDS(s) dated 03/20/2025 and 03/16/2026 have been considered and placed in the application file.
Priority
Applicant claims the benefit of PRO 63/376,065 filed 09/16/2022. Claims 1-36 have been afforded the benefit of this filing date.
Overview
Claims 1-36 are pending in this application and have been considered below.
Claims 1-36 are rejected.
Applicant Arguments:
In regards to the argument on Argument 1, Applicant/s state/s “The drawings are objected to for failing to include a reference numeral (42) mentioned in ¶[0086] in the description of FIG. 1A. Paragraph [0086] of the specification has been amended to replace reference numeral 42 with reference numeral 12. Support for this amendment can be found in at least paragraph [0084]. Accordingly, the objection is moot and should be withdrawn.” therefore, the drawing objections should be withdrawn. (See Remarks, page 14, paragraph 1).
In regards to the argument on Argument 2, Applicant/s state/s “Claim 21 has been amended to remove any references to an "illuminator." Accordingly, this point is now moot” therefore, the 35 USC 112(f) claim interpretation should be withdrawn (See Remarks, page 14, paragraph 2).
In regards to the argument on Argument 3, Applicant/s state/s “the cited references fail to disclose or suggest determining a measure of visual enhancement at all, much less determining a measure of visual enhancement by comparing (i) a signal strength of the first color relative to signal strengths of other colors in a first region to (ii) a signal strength of the first color relative to signal strengths of other colors in a second region” therefore, the rejection of 35 U.S.C. 103 should be withdrawn (See Remarks, page 14, paragraph 4).
In regards to the argument on Argument 4, Applicant/s state/s “the rejection of claim 1 should be withdrawn. Independent claims 11, 21, 28, and 32 have been amended to include limitations analogous to those discussed above and, thus, the rejection of claims 11, 21, 28, and 32 should be withdrawn for at least the same reasons. The rejection of claims 2-10, 12-20, 22-27, 29-31, and 33-36 should be withdrawn at least for the respective dependencies of the claims.” therefore, the rejection of 35 U.S.C. 103 should be withdrawn (See Remarks, page 15, paragraph 1).
Examiner’s Responses:
In response to Argument 1, Applicant’s arguments, see Remarks, filed 03/16/2026, with respect to the drawings have been considered and are persuasive. The drawing objections are withdrawn.
In response to Argument 2, Applicant’s arguments, see Remarks, filed 03/16/2026, with respect to the 112(f) claim interpretation have been considered and are persuasive. The 112(f) claim interpretation is withdrawn.
In response to Argument 3, Applicant’s arguments, see Remarks, filed 03/16/2026, with respect to claim 1, 11, 21, and 28 have been considered but are moot in view of new ground(s) of rejection caused by the amendments. Upon further consideration, a new ground(s) of rejection is made for Claim 1, 11, 21, and 28 under 35 U.S.C. 103 in view of Gurevich et al. (US Patent Publication US 2021/0007687 A1 hereafter referred to as Gurevich) in view of Gurevich et al (US Patent Publication US 2018/0028079 A1 hereafter referred to as Gurevich 2).
The Examiner finds that Gurevich teaches on the amended claim language “determining a measure of visual enhancement of the anatomy or pathology of interest in the color image” in amended claim 1 with the amendment changing the scope of the “comparing (i) a signal strength of the first color relative to signal strengths of other colors in a first region to (ii) a signal strength of the first color relative to signal strengths of other colors in a second region.”.
Specifically, Gurevich teaches a measure of visual enhancement in the form of measuring the signal intensity of the coloring agent in the feature of interest, which in this case is the tissue of the subject as disclosed in ¶0006, ¶0200, ¶0093, ¶0099. We determine claim scope not solely on the basis of claim language, but also on giving claims their broadest reasonable construction in light of the specification as it would be interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). See also Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim.”). The Examiner interprets that under broadest reasonable interpretation “measure of visual enhancement” has no special definition in the claims, and therefore can be interpreted as signal intensity. Applicant argues that “the cited references fail to disclose or suggest determining a measure of visual enhancement at all, much less determining a measure of visual enhancement by comparing (i) a signal strength of the first color relative to signal strengths of other colors in a first region to (ii) a signal strength of the first color relative to signal strengths of other colors in a second region”. Gurevich does determine a measure of visual enhancement. Gurevich does not disclose the specific limitation of (i) a signal strength of the first color relative to signal strengths of other colors in a first region to (ii) a signal strength of the first color relative to signal strengths of other colors in a second region, as recited in Claim 1, 11, 21, and 28. However, the Examiner interprets that Gurevich teaches the main concept of obtaining an image of fluorescent imaging and identifying features based of the fluorescent signal intensity, the additional details of the function and characteristics of the main concepts as stated above by the applicant in the amendments is taught by Gurevich 2 in the details of the rejection below. The Examiner will maintain prior art Gurevich and details of the rejection are below.
In response to Argument 4, Applicant’s arguments, see Remarks, filed 03/16/2026, with respect to claims 32-36 have been considered but are moot in view of new ground(s) of rejection caused by the amendments. Upon further consideration, a new ground(s) of rejection is made for Claims 32-36 under 35 U.S.C. 103 in view of Gurevich et al. (US Patent Publication US 2021/0007687 A1 in view of Gurevich 2 in further view of Steinbach et al (US Patent Publication 2014/0276008 A1 hereafter referred to as Steinbach).
The Examiner finds that Steinbach teaches on the amended claim language “pixel data”, “pixel values”, and “calculate a first contribution value” in amended claim 32 with the amendment changing the scope of the “comparing signal strengths”.
Specifically, Steinbach teaches pixel data and calculating a pixel value and calculating a contribution value of the pixels which in this case if calculating a ratio encoded as a spectrum of colors for the pixel as disclosed in Table 1, ¶0129, and ¶0155. We determine claim scope not solely on the basis of claim language, but also on giving claims their broadest reasonable construction in light of the specification as it would be interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). See also Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim.”). The Examiner interprets that under broadest reasonable interpretation “contribution value” has no special definition in the claims, and therefore can be interpreted as a ratio encoded as a spectrum of colors. Applicant argues that “Independent claims 11, 21, 28, and 32 have been amended to include limitations analogous to those discussed above and, thus, the rejection of claims 11, 21, 28, and 32 should be withdrawn for at least the same reasons. The rejection of claims 2-10, 12-20, 22-27, 29-31, and 33-36 should be withdrawn at least for the respective dependencies of the claims”. Steinbach does disclose pixel data and calculating a pixel value and calculating a contribution value of the pixels which in this case if calculating a ratio encoded as a spectrum of colors for the pixel. Steinbach does not disclose comparing signal strengths as recited in Claim 32. However, the Examiner interprets that Gurevich teaches the main concept of obtaining an image of fluorescent imaging and identifying features based of the fluorescent signal intensity, the additional details of the function and characteristics of the main concepts as stated above by the applicant in the amendments is taught by Gurevich 2 in view of Steinbach in the details of the rejection below. The Examiner will maintain prior art Steinbach and details of the rejection are below.
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.
Claims 1-31 are rejected under 35 U.S.C. 103 as unpatentable over Gurevich et al. (US Patent Publication US 2021/0007687 A1 hereafter referred to as Gurevich) in view of Gurevich et al (US Patent Publication US 2018/0028079 A1 hereafter referred to as Gurevich 2).
Regarding Claim 1, Gurevich teaches a method for assessing fluorescence imaging (Gurevich ¶0016 discloses using fluorescence imaging) agent-based visual enhancement (Gurevich ¶0022 discloses the use of an imaging agent in the method) in a color image (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed)
identifying at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) of the color image (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) that is encompassed by a portion of anatomy or pathology of interest (Gurevich ¶0099 discloses the method in which the feature of interest is imaged) in which the fluorescence imaging agent is present (Gurevich ¶0099 discloses how the second image modality only take images when the fluorescence agent is present);
identifying at least one second region (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer ¶0156 discloses sub-regions of frames) of the color image that is not encompassed by the anatomy or pathology of interest (Gurevich ¶0156 discloses using similarity scores to determine if the region of interest is located within the frames); and
determining a measure of visual enhancement (Gurevich ¶0200 discloses measurement of the signal intensity of the agent) the of the anatomy or pathology of interest in the color image (Gurevich Fig 8, 802 ¶0093, ¶0099 discloses the color visualization of the feature of interest);
in the at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) in the at least one second region (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer ¶0156 discloses sub-regions of frames).
Gurevich does not explicitly teach being represented in a first color, by comparing: (i) a signal strength of the first color relative to signal strengths of other colors to (ii) a signal strength of the first color relative to signal strengths of the other colors.
Gurevich 2 is in the same field of fluorescent image analysis including color to determine the difference between tissues. Further, Gurevich 2 teaches being represented in a first color (Gurevich 2 ¶0104 discloses using isosulfan blue for the first injection and ICG for the second injection for comparison) by comparing: (i) a signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to signal strengths of other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region)
to (ii) a signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gurevich by incorporating the two different fluorescent dye colors and using the dyes signal strength (color intensity) as a comparison between regions as taught by Gurevich, to make an invention that can help to determine the difference between cancerous and non-cancerous tissue as it pertains to visual guidance during surgeries or diagnosis, thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to correctly assess blood flow and/or tissue perfusion in tissue. For example, in treating patients with wounded tissue, clinicians must correctly assess blood flow and/or tissue perfusion in and around a wound site, since poor tissue perfusion will have an adverse effect on the healing process. An accurate assessment of blood flow and/or tissue perfusion increases the chances of successful healing of both acute (e.g., surgical) and chronic wounds (Gurevich 2, ¶0004).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 2, Gurevich in view of Gurevich 2 teaches the method of claim 1, wherein the measure of visual enhancement (Gurevich ¶0200 discloses measurement of the signal intensity of the agent) is associated with a first dose of the fluorescence imaging agent (Gurevich ¶0191, ¶0198-¶0199 discloses how much of the agent to give and how long before the region of interest is needed to show effectiveness), and the method further comprises comparing the measure of visual enhancement (Gurevich ¶0133-¶0135 discloses comparing the level of intensity of the visual enhancement) associated with the first dose with a measure of visual enhancement (Gurevich ¶0191, ¶0198-¶0199 discloses how much of the agent to give and how long before the region of interest is needed to show effectiveness) associated with a second dose of the fluorescence imaging agent (Gurevich ¶0191, ¶0198-¶0199 discloses multiple doses of varying concentration can be given) to determine a preferred dose (Gurevich ¶0191- ¶0194 discloses the choice of imaging agents and preferred amount) of the fluorescence imaging agent (Gurevich ¶0022 discloses the use of an imaging agent in the method) for imaging the anatomy or pathology of interest (Gurevich ¶0099 discloses the method in which the feature of interest is imaged). See Claim 1 for rationale, its parent claim.
Regarding Claim 3, Gurevich in view of Gurevich 2 teaches the method of claim 1, wherein the color image (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) was generated by a surgical visualization system (Gurevich ¶0034, ¶0101 discloses the imaging frames being displayed during a surgical procedure, ¶0112 discloses the image frames being generated in real time during the surgical procedure), the measure of visual enhancement is associated with a first configuration of the surgical visualization system (Gurevich ¶0152-¶0154 discloses the first configuration of the imaging modality and the image frames produced from it), and the method further comprises comparing the measure of visual enhancement associated with the first configuration of the surgical visualization system (Gurevich ¶0152 discloses comparing the first imaging mode frame with a first and second predetermined threshold) with a measure of visual enhancement associated with a second configuration of the surgical visualization system to determine a preferred configuration (Gurevich ¶0153 discloses comparing the first imaging mode frame with a first and second predetermined threshold and determine based on the threshold which would be a better imaging mode for the surgery) of the surgical visualization system for image-guided surgery of the anatomy or pathology of interest (Gurevich ¶0112 discloses the image frames being generated in real time during the surgical procedure). See Claim 1 for rationale, its parent claim.
Regarding Claim 4, Gurevich in view of Gurevich 2 teaches the method of claim 1, comprising determining the signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region) in the at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) by calculating a first ratio (Gurevich ¶0151 discloses the intensity proportion being determined) of a measure of the signal strength (Gurevich Fig 6, 602, ¶0053, ¶0132 discloses determining the signal intensity) of the first color to a sum of measures (Gurevich 2 ¶0104-¶0105 discloses the total does of the injection of isosulfan blue in comparison to the total does of ICG) of the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region) in the at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject). See Claim 1 for rationale, its parent claim.
Regarding Claim 5, Gurevich in view of Gurevich 2 teaches the method of claim 4, comprising determining the signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region) in the at least one second region (Gurevich ¶0156 discloses sub-regions of frames) by calculating a second ratio of measure of the signal strength (Gurevich ¶0152 discloses a second threshold being determined based on the signal proportion) of the first color to a sum of measures (Gurevich 2 ¶0104-¶0105 discloses the total does of the injection of isosulfan blue in comparison to the total does of ICG) of the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region) in the at least one second region (Gurevich ¶0156 discloses sub-regions of frames), and wherein the measure of visual enhancement comprises a ratio of the first ratio to the second ratio (Gurevich ¶0153 discloses comparing the signal intensity based on the proportional threshold of the first and second imaging frame). See Claim 1 for rationale, its parent claim.
Regarding Claim 6, Gurevich in view of Gurevich 2 teaches the method of claim 1, further comprising comparing the measure of visual enhancement (Gurevich Fig 6, 602, ¶0053, ¶0132 discloses determining the signal intensity) of the anatomy or pathology of interest (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) in the color image (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) with a measure of visual enhancement of the anatomy or pathology of interest in a second color image (Gurevich ¶0043 discloses second imaging modality frames) wherein the second image does not include a contribution from the fluorescence imaging agent because the fluorescence imaging agent was not present (Gurevich ¶0102, ¶0138 discloses the images showing when the imaging agent is not present) in the at least a portion of anatomy or pathology of interest (Gurevich ¶0102 discloses the images showing when the imaging agent is not present in the ureter), the fluorescence imaging agent was not excited with fluorescence excitation light (Gurevich ¶0182 discloses whether or not the fluorophores are excited), or fluorescence imaging data was not used to generate the second image (Gurevich ¶0102, ¶0138 discloses the images showing when the imaging agent is not present in the ureter). See Claim 1 for rationale, its parent claim.
Regarding Claim 7, Gurevich in view of Gurevich 2 teaches the method of claim 1, wherein identifying the at least one first region of the color image (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) and the at least one second region of the color image (Gurevich ¶0156 discloses sub-regions of frames) comprises identifying a portion of the color image that includes the portion of the anatomy or pathology of interest (Gurevich ¶0188, ¶0093, ¶0099 discloses persistent visualization of the feature of interest in the tissue) and comparing pixel intensities (Gurevich 2 ¶0065, ¶0084. ¶0186, ¶0191 and 3B discloses comparing pixels value intensities over time) of the first color within the portion of the color image (Gurevich Fig 2, 204, 206 discloses comparing the intensity and selecting the frames based on the similarity between the intensities) to identify the at least one first region and the at least one second region (Gurevich ¶0156 discloses comparing subregions of frames to determine the similarity score to determine the region of interest) See Claim 1 for rationale, its parent claim.
Regarding Claim 8, Gurevich in view of Gurevich 2 teaches the method of claim 1, wherein the anatomy or pathology of interest comprises a vessel (Gurevich ¶0201 discloses the area of interest being a vessel). See Claim 1 for rationale, its parent claim.
Regarding Claim 9, Gurevich in view of Gurevich 2 teaches the method of claim 8, wherein the vessel comprises a ureter (Gurevich ¶0205 discloses the vessel being a ureter) See Claim 1 for rationale, its parent claim.
Regarding Claim 10, Gurevich in view of Gurevich 2 teaches the method of claim 1, wherein the fluorescence imaging agent is pudexacianinium chloride (Gurevich ¶0200- ¶0203 discloses the imaging agent being ICG, which pudexacianinium chloride is a derivative of). See Claim 1 for rationale, its parent claim.
Regarding Claim 11, Gurevich teaches a method for assessing fluorescence imaging (Gurevich ¶0016 discloses using fluorescence imaging) agent-based visual enhancement (Gurevich ¶0022 discloses the use of an imaging agent in the method) in a color image (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed)
displaying the color image on a display (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) to a user (Gurevich ¶0006 discloses the feature of the tissue being displayed to the user);
receiving, by a computing system (Gurevich ¶0106 discloses the method being performed by a computer system), an input from the user corresponding to selection (Gurevich ¶0120 discloses selecting a frame) of at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) of the color image that is encompassed by a portion of anatomy or pathology of interest (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) in which the fluorescence imaging agent is present (Gurevich ¶0099 discloses how the second image modality only take images when the fluorescence agent is present);
receiving, by the computing system (Gurevich ¶0106 discloses the method being performed by a computer system), an input from the user corresponding to selection (Gurevich ¶0120 discloses selecting a frame) of at least one second region (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer ¶0156 discloses sub-regions of frames) of the color image that is not encompassed by the anatomy or pathology of interest (Gurevich ¶0156 discloses using similarity scores to determine if the region of interest is located within the frames); and
computing, by the computing system (Gurevich ¶0106 discloses the method being performed by a computer system), a measure of visual enhancement (Gurevich ¶0200 discloses measurement of the signal intensity of the agent) of the anatomy or pathology of interest in the color image (Gurevich Fig 8, 802 ¶0093, ¶0099 discloses the color visualization of the feature of interest) in the at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) in the at least one second region (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer ¶0156 discloses sub-regions of frames).
Gurevich does not explicitly teach being represented in a first color, based on comparing: (i) a signal strength of the first color relative to signal strengths of other colors to (ii) a signal strength of the first color relative to signal strengths of the other colors.
Gurevich 2 is in the same field of fluorescent image analysis including color to determine the difference between tissues. Further, Gurevich 2 teaches being represented in a first color (Gurevich 2 ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison) based on comparing: (i) a signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to signal strengths of other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region)
to (ii) a signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gurevich by incorporating the two different fluorescent dye colors and using the dyes signal strength (color intensity) as a comparison between regions as taught by Gurevich, to make an invention that can help to determine the difference between cancerous and non-cancerous tissue as it pertains to visual guidance during surgeries or diagnosis, thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to correctly assess blood flow and/or tissue perfusion in tissue. For example, in treating patients with wounded tissue, clinicians must correctly assess blood flow and/or tissue perfusion in and around a wound site, since poor tissue perfusion will have an adverse effect on the healing process. An accurate assessment of blood flow and/or tissue perfusion increases the chances of successful healing of both acute (e.g., surgical) and chronic wounds (Gurevich 2, ¶0004).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 12, Gurevich in view of Gurevich 2 teaches the method of claim 11, comprising:
illuminating tissue that comprises the anatomy or pathology of interest with fluorescence excitation light (Gurevich ¶0184 discloses illuminating the object with illumination or excitation light) generated by an illumination system (Gurevich ¶0044 discloses a system that includes a light source for providing visible illumination) for causing fluorescence emission by the fluorescence imaging agent (Gurevich ¶0148, ¶0178 discloses fluorescence emission light used to cause fluorescence emission from the agent) and with visible light generated by the illumination system (Gurevich ¶0177 discloses a light source assembly configure to provide visible light);
detecting fluorescence emission (Gurevich ¶0206 discloses detection of optical agents) and reflected light from the tissue (Gurevich ¶0182 discloses reflected light frames from the object) by an image sensor assembly (Gurevich ¶0179, ¶0182, ¶0183 disclose the image sensor assembly); and
generating the color image (Gurevich ¶0143 disclose generating the color image) based on the light detected by the image sensor assembly (Gurevich ¶0179, ¶0182, ¶0183 disclose the image sensor assembly and how the light is detected). See Claim 11 for rationale, its parent claim.
Regarding Claim 13, Gurevich in view of Gurevich 2 teaches the method of claim 11, wherein the measure of visual enhancement (Gurevich ¶0200 discloses measurement of the signal intensity of the agent) is associated with a first dose of the fluorescence imaging agent (Gurevich ¶0191, ¶0198-¶0199 discloses how much of the agent to give and how long before the region of interest is needed to show effectiveness), and the method further comprises comparing the measure of visual enhancement (Gurevich ¶0133-¶0135 discloses comparing the level of intensity of the visual enhancement) associated with the first dose with a measure of visual enhancement (Gurevich ¶0191, ¶0198-¶0199 discloses how much of the agent to give and how long before the region of interest is needed to show effectiveness) associated with a second dose of the fluorescence imaging agent (Gurevich ¶0191, ¶0198-¶0199 discloses multiple doses of varying concentration can be given) to determine a preferred dose (Gurevich ¶0191- ¶0194 discloses the choice of imaging agents and preferred amount) of the fluorescence imaging agent (Gurevich ¶0022 discloses the use of an imaging agent in the method) for imaging the anatomy or pathology of interest (Gurevich ¶0099 discloses the method in which the feature of interest is imaged). See Claim 11 for rationale, its parent claim.
Regarding Claim 14, Gurevich in view of Gurevich 2 teaches the method of claim 11, wherein the color image (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) was generated by a surgical visualization system (Gurevich ¶0034, ¶0101 discloses the imaging frames being displayed during a surgical procedure, ¶0112 discloses the image frames being generated in real time during the surgical procedure), the measure of visual enhancement is associated with a first configuration of the surgical visualization system (Gurevich ¶0152-¶0154 discloses the first configuration of the imaging modality and the image frames produced from it), and the method further comprises comparing the measure of visual enhancement associated with the first configuration of the surgical visualization system (Gurevich ¶0152 discloses comparing the first imaging mode frame with a first and second predetermined threshold) with a measure of visual enhancement associated with a second configuration of the surgical visualization system to determine a preferred configuration (Gurevich ¶0153 discloses comparing the first imaging mode frame with a first and second predetermined threshold and determine based on the threshold which would be a better imaging mode for the surgery) of the surgical visualization system for image-guided surgery of the anatomy or pathology of interest (Gurevich ¶0112 discloses the image frames being generated in real time during the surgical procedure). See Claim 11 for rationale, its parent claim.
Regarding Claim 15, Gurevich in view of Gurevich 2 teaches the method of claim 11, comprising computing signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region) in the at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) by calculating a first ratio (Gurevich ¶0151 discloses the intensity proportion being determined) of a measure of the signal strength (Gurevich Fig 6, 602, ¶0053, ¶0132 discloses determining the signal intensity) of the first color to a sum of measures (Gurevich 2 ¶0104-¶0105 discloses the total does of the injection of isosulfan blue in comparison to the total does of ICG) of the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region)in the at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject). See Claim 11 for rationale, its parent claim.
Regarding Claim 16, Gurevich in view of Gurevich 2 teaches the method of claim 15, comprising computing the signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region) in the at least one second region (Gurevich ¶0156 discloses sub-regions of frames) by calculating a second ratio of a measure of the signal strength (Gurevich ¶0152 discloses a second threshold being determined based on the signal proportion) of the first color to a sum of measures (Gurevich 2 ¶0104-¶0105 discloses the total does of the injection of isosulfan blue in comparison to the total does of ICG) of the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region) in the at least one second region (Gurevich ¶0156 discloses sub-regions of frames), and wherein the measure of visual enhancement comprises a ratio of the first ratio to the second ratio (Gurevich ¶0153 discloses comparing the signal intensity based on the proportional threshold of the first and second imaging frame). See Claim 11 for rationale, its parent claim.
Regarding Claim 17, Gurevich in view of Gurevich 2 teaches the method of claim 11, wherein receiving inputs from the user corresponding to selections (Gurevich ¶0120 discloses selecting a frame) of the at least one first region of the color image (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) and the at least one second region of the color image (Gurevich ¶0156 discloses sub-regions of frames) comprises receiving an input from the user (Gurevich ¶0120 discloses selecting a frame) corresponding to selection of a portion of the color image that includes the portion of the anatomy or pathology of interest (Gurevich ¶0188, ¶0093, ¶0099 discloses persistent visualization of the feature of interest in the tissue) and displaying to the user pixel intensities of the first color (Gurevich 2 ¶0065, ¶0084. ¶0186, ¶0191 and 3B discloses comparing pixels value intensities over time) within the selected portion of the color image (Gurevich ¶0140-¶0142 discloses selecting the visible light frame). See Claim 11 for rationale, its parent claim.
Regarding Claim 18, Gurevich in view of Gurevich 2 teaches the method of claim 11, wherein the anatomy or pathology of interest comprises a vessel (Gurevich ¶0201 discloses the area of interest being a vessel). See Claim 11 for rationale, its parent claim.
Regarding Claim 19, Gurevich in view of Gurevich 2 teaches the method of claim 18, wherein the vessel comprises a ureter (Gurevich ¶0205 discloses the vessel being a ureter). See Claim 11 for rationale, its parent claim.
Regarding Claim 20, Gurevich in view of Gurevich 2 teaches the method of claim 11, wherein the fluorescence imaging agent is pudexacianinium chloride(Gurevich ¶0200- ¶0203 discloses the imaging agent being ICG, which pudexacianinium chloride is a derivative of). See Claim 11 for rationale, its parent claim.
Regarding Claim 21, Gurevich teaches a system for assessing fluorescence imaging agent-based visual enhancement (Gurevich ¶0200 discloses measurement of the signal intensity of the agent) in a color image (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) the system comprising:
an image guided surgery system (Gurevich ¶0112 discloses the image frames being generated in real time during the surgical procedure) comprising:
A light source (Gurevich ¶0044 discloses a system that includes a light source for providing visible illumination) configured to illuminate tissue that comprises the anatomy or pathology of interest with fluorescence excitation light (Gurevich ¶0184 discloses illuminating the object with illumination or excitation light) generated for causing fluorescence emission by the fluorescence imaging agent (Gurevich ¶0148, ¶0178 discloses fluorescence emission light used to cause fluorescence emission from the agent) and with visible light (Gurevich ¶0177 discloses a light source assembly configure to provide visible light),
an image sensor assembly (Gurevich ¶0179, ¶0182, ¶0183 disclose the image sensor assembly) configured to detect fluorescence emission (Gurevich ¶0206 discloses detection of optical agents) and reflected light from the tissue (Gurevich ¶0182 discloses reflected light frames from the object), and an image processing system (Gurevich ¶0184 discloses an image processing scheme) configured to generate the color image(Gurevich ¶0143 disclose generating the color image); and
a computing system comprising a display, one or more processors, memory, and one or more programs stored in the memory and including instruction for execution by the one or more processors (Gurevich ¶0080 discloses a non-transitory computer readable medium with processors for executing the system) for causing the computing system to:
display the color image on the display (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) to a user (Gurevich ¶0006 discloses the feature of the tissue being displayed to the user),
receive an input from the user corresponding to selection (Gurevich ¶0120 discloses selecting a frame) of at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) of the color image that is encompassed by a portion of anatomy or pathology of interest (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) in which the fluorescence imaging agent is present (Gurevich ¶0099 discloses how the second image modality only take images when the fluorescence agent is present),
receive an input from the user corresponding to selection (Gurevich ¶0120 discloses selecting a frame) of at least one second region (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer ¶0156 discloses sub-regions of frames) of the color image that is not encompassed by the anatomy or pathology of interest (Gurevich ¶0156 discloses using similarity scores to determine if the region of interest is located within the frames), and
compute a measure of visual enhancement (Gurevich ¶0200 discloses measurement of the signal intensity of the agent) of the anatomy or pathology of interest in the color image (Gurevich Fig 8, 802 ¶0093, ¶0099 discloses the color visualization of the feature of interest)
in the at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) in the at least one second region (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer ¶0156 discloses sub-regions of frames).
Gurevich does not explicitly teach being represented in a first color based on comparing: (i) a signal strength of the first color relative to signal strengths of other color to (ii) a signal strength of the first color relative to signal strengths of the other colors.
Gurevich 2 is in the same field of fluorescent image analysis including color to determine the difference between tissues. Further, Gurevich 2 teaches being represented in a first color (Gurevich 2 ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison) based on comparing: (i) a signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to signal strengths of other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region)
to (ii) a signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gurevich by incorporating the two different fluorescent dye colors and using the dyes signal strength (color intensity) as a comparison between regions as taught by Gurevich, to make an invention that can help to determine the difference between cancerous and non-cancerous tissue as it pertains to visual guidance during surgeries or diagnosis, thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to correctly assess blood flow and/or tissue perfusion in tissue. For example, in treating patients with wounded tissue, clinicians must correctly assess blood flow and/or tissue perfusion in and around a wound site, since poor tissue perfusion will have an adverse effect on the healing process. An accurate assessment of blood flow and/or tissue perfusion increases the chances of successful healing of both acute (e.g., surgical) and chronic wounds (Gurevich 2, ¶0004).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 22, Gurevich in view of Gurevich 2 teaches the system of claim 21, wherein the one or more programs include instructions (Gurevich ¶0043 disclose one of more programs including instructions) for computing signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region) in the at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) by calculating a first ratio (Gurevich ¶0151 discloses the intensity proportion being determined) of a measure of the signal strength (Gurevich Fig 6, 602, ¶0053, ¶0132 discloses determining the signal intensity) of the first color to a sum of measures (Gurevich 2 ¶0104-¶0105 discloses the total does of the injection of isosulfan blue in comparison to the total does of ICG) of the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region) in the at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject). See Claim 21 for rationale, its parent claim.
Regarding Claim 23, Gurevich in view of Gurevich 2 teaches the system of claim 22, wherein the one or more programs include instructions (Gurevich ¶0043 disclose one of more programs including instructions) for computing the signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region) in the at least one second region (Gurevich ¶0156 discloses sub-regions of frames) by calculating a second ratio of a measure of the signal strength (Gurevich ¶0152 discloses a second threshold being determined based on the signal proportion) of the first color to a sum of measures (Gurevich 2 ¶0104-¶0105 discloses the total does of the injection of isosulfan blue in comparison to the total does of ICG) of the signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region) in the at least one second region (Gurevich ¶0156 discloses sub-regions of frames), and wherein the measure of visual enhancement comprises a ratio of the first ratio to the second ratio (Gurevich ¶0153 discloses comparing the signal intensity based on the proportional threshold of the first and second imaging frame). See Claim 21 for rationale, its parent claim.
Regarding Claim 24, Gurevich in view of Gurevich 2 teaches the system of claim 21, wherein receiving inputs from the user corresponding to selections (Gurevich ¶0120 discloses selecting a frame) of the at least one first region of the color image (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) and the at least one second region of the color image (Gurevich ¶0156 discloses sub-regions of frames) comprises receiving an input from the user (Gurevich ¶0120 discloses selecting a frame) corresponding to selection of a portion of the color image that includes the portion of the anatomy or pathology of interest (Gurevich ¶0188, ¶0093, ¶0099 discloses persistent visualization of the feature of interest in the tissue) and displaying to the user pixel intensities of the first color (Gurevich 2 ¶0065, ¶0084. ¶0186, ¶0191 and 3B discloses comparing pixels value intensities over time) within the selected portion of the color image (Gurevich ¶0140-¶0142 discloses selecting the visible light frame). See Claim 21 for rationale, its parent claim.
Regarding Claim 25, Gurevich in view of Gurevich 2 teaches the system of claim 21, wherein the anatomy or pathology of interest comprises a vessel (Gurevich ¶0201 discloses the area of interest being a vessel). See Claim 21 for rationale, its parent claim.
Regarding Claim 26, Gurevich in view of Gurevich 2 teaches the system of claim 25, wherein the vessel comprises a ureter (Gurevich ¶0205 discloses the vessel being a ureter). See Claim 21 for rationale, its parent claim.
Regarding Claim 27, Gurevich in view of Gurevich 2 teaches the system of claim 21, wherein the fluorescence imaging agent is pudexacianinium chloride (Gurevich ¶0200- ¶0203 discloses the imaging agent being ICG, which pudexacianinium chloride is a derivative of). See Claim 21 for rationale, its parent claim.
Regarding Claim 28, Gurevich teaches a method for determining a relationship between a fluorescence imaging agent-based visual enhancement in a color image of a patient (Gurevich ¶0135 discloses determining the relationship between the frames of the agent enhanced image) and the concentration of the fluorescence imaging agent in a biological sample from the patient (Gurevich ¶0197-¶0200 disclose the concentrations of the agent in the sample), wherein a fluorescence imaging agent signal (Gurevich ¶0201 discloses the fluorescent signal intensity) in the color image (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) the method comprising:
identifying at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) of the color image (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) that is encompassed by a portion of anatomy or pathology of interest (Gurevich ¶0099 discloses the method in which the feature of interest is imaged) in which the fluorescence imaging agent is present (Gurevich ¶0099 discloses how the second image modality only take images when the fluorescence agent is present);
identifying at least one second region (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer¶0156 discloses sub-regions of frames) of the color image that is not encompassed by the anatomy or pathology of interest (Gurevich ¶0156 discloses using similarity scores to determine if the region of interest is located within the frames); and
determining a measure of visual enhancement (Gurevich ¶0200 discloses measurement of the signal intensity of the agent) the of the anatomy or pathology of interest in the color image (Gurevich Fig 8, 802 ¶0093, ¶0099 discloses the color visualization of the feature of interest)
in the at least one first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject)
in the at least one second region (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer ¶0156 discloses sub-regions of frames); and
calculating the relationship (Gurevich ¶0047 discloses calculating a similarity score) between the fluorescence imaging agent-based visual enhancement in the color image (Gurevich ¶0135 discloses determining the relationship between the frames of the agent enhanced image) and the concentration of the fluorescence imaging agent in the biological sample (Gurevich ¶0135 discloses determining the relationship between the frames of the agent enhanced image).
Gurevich does not explicitly teach being represented in a first color by comparing: (i) a signal strength of the first color relative to signal strengths of other colors to (ii) a signal strength of the first color relative to signal strengths of the other colors.
Gurevich 2 is in the same field of fluorescent image analysis including color to determine the difference between tissues. Further, Gurevich 2 teaches being represented in a first color (Gurevich 2 ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison) by comparing: (i) a signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to signal strengths of other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region)
to (ii) a signal strength of the first color (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength) relative to signal strengths of the other colors (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gurevich by incorporating the two different fluorescent dye colors and using the dyes signal strength (color intensity) as a comparison between regions as taught by Gurevich, to make an invention that can help to determine the difference between cancerous and non-cancerous tissue as it pertains to visual guidance during surgeries or diagnosis, thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to correctly assess blood flow and/or tissue perfusion in tissue. For example, in treating patients with wounded tissue, clinicians must correctly assess blood flow and/or tissue perfusion in and around a wound site, since poor tissue perfusion will have an adverse effect on the healing process. An accurate assessment of blood flow and/or tissue perfusion increases the chances of successful healing of both acute (e.g., surgical) and chronic wounds (Gurevich 2, ¶0004).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 29, Gurevich in view of Gurevich 2 teaches the method of claim 28, wherein the measure of visual enhancement is determined at two or more different dosage amounts of the fluorescence imaging agent (Gurevich ¶0198-¶0200 discloses the difference dosage amounts of different imaging agents), and calculating the relationship comprises comparing the fluorescence imaging agent-based visual enhancement in the color image (Gurevich ¶0154, ¶0168 disclose the visual enhancement methods) to the concentration of the fluorescence imaging agent in the biological sample (Gurevich ¶0200 disclose how the concentration of the agent relates to its presence in the sample) at each of the two or more dosage amounts (Gurevich ¶0198-¶0200 discloses the difference dosage amounts of different imaging agents). See Claim 28 for rationale, its parent claim.
Regarding Claim 30, Gurevich in view of Gurevich 2 teaches the method of claim 29, wherein determining the relationship (Gurevich ¶0200 disclose how the concentration of the agent relates to its presence in the sample) comprises determining a dosage range over which there is a positive linear correlation (Gurevich ¶0197, ¶0200 disclose a dosage range that has a positive linear correlation based on the amount given) between the fluorescence imaging agent-based visual enhancement in a color image of a patient (Gurevich ¶0154, ¶0168 disclose the visual enhancement methods) and the concentration of the fluorescence imaging agent in a biological sample from the patient (Gurevich ¶0200 disclose how the concentration of the agent relates to its presence in the sample). See Claim 28 for rationale, its parent claim.
Regarding Claim 31, Gurevich in view of Gurevich 2 teaches the method of claim 28, wherein the biological sample comprises urine, blood, lymphatic fluid, or feces (Gurevich ¶0024, ¶0061 ¶0101, discloses the sample being urine, ¶0200 discloses the sample being blood). See Claim 28 for rationale, its parent claim.
Claims 32-36 are rejected under 35 U.S.C. 103 as unpatentable over Gurevich et al. (US in view of Gurevich 2 in further view of Steinbach et al (US Patent Publication 2014/0276008 A1 hereafter referred to as Steinbach).
Regarding Claim 32, Gurevich teaches a system for assessing fluorescent imaging agent-based visual enhancement in a color image (Gurevich Fig 2, 204, ¶0132 disclose analyzing the fluorescence intensity of the frame), the system comprising:
one or more processors (Gurevich ¶0043 discloses one or more processors); and
memory communicatively coupled with the one or more processors (Gurevich ¶0043 discloses the memory being connected to one or more processors), the memory storing instructions that, when executed by the one or more processors (Gurevich ¶0043 discloses the processors storing programs to execute instructions), cause the one or more processors to:
analyze pixel data of the color image (Gurevich Fig 2, 204, ¶0132 disclose analyzing the fluorescence intensity of the frame) to identify a first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) of the color image (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed) associated with presence of a fluorescence imaging agent (Gurevich ¶0099 discloses how the second image modality only take images when the fluorescence agent is present) and a second region (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer¶0156 discloses sub-regions of frames) of the color image associated with lack of presence of the fluorescence imaging agent (Gurevich ¶0102 discloses visualization of the ureter during the periods when the agent is not present), the first region corresponding to a portion of anatomy or pathology of interest (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject), and the fluorescence imaging agent(Gurevich ¶0022 discloses the use of an imaging agent in the method)
of the first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject)
for the second region (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer ¶0156 discloses sub-regions of frames)
determine a visual enhancement value (Gurevich ¶0010 discloses calculating a similarity score, ¶0200 discloses measurement of the signal intensity of the agent) associated with the fluorescence imaging agent being present (Gurevich ¶0022 discloses the second imaging mode being one that include imaging agent) in the first region in the color image (Gurevich ¶0137, ¶0143, ¶0179 discloses a color image being used and displayed).
Gurevich does not explicitly teach being represented in a first color for the first region based comparing signal strengths, and signal strengths based on comparing signal strengths and signal strengths.
Gurevich 2 is in the same field of fluorescent image analysis including color to determine the difference between tissues. Further, Gurevich 2 teaches being represented in a first color (Gurevich 2 ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison)
for the first region based comparing signal strengths (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength)
and signal strengths (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region)
based on comparing signal strengths (Gurevich 2 ¶0129 discloses 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, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the examiner is interpreting the signal intensity to be equivalent under broadest reasonable interpretation to signal strength)
of the second region that are associated with the first color and signal strengths (Gurevich 2 ¶0020 discloses how a color and intensity value are assigned to each separate subregion on the fluorescent images and ¶0104 discloses how the different colors may be used in a analysis and quantification in the processing of the images, ¶0104 discloses using isosulfan blue for the first injection and Icg for the second injection for comparison, the ICG is taken up by the lymph system to map the lymph system which under broadest reasonable interpretation can be interpreted as a first region, while the icg is used to identify the nodes which under broadest reasonable interpretation can be interpreted as a second region).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gurevich by incorporating the two different fluorescent dye colors and using the dyes signal strength (color intensity) as a comparison between regions as taught by Gurevich, to make an invention that can help to determine the difference between cancerous and non-cancerous tissue as it pertains to visual guidance during surgeries or diagnosis, thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to correctly assess blood flow and/or tissue perfusion in tissue. For example, in treating patients with wounded tissue, clinicians must correctly assess blood flow and/or tissue perfusion in and around a wound site, since poor tissue perfusion will have an adverse effect on the healing process. An accurate assessment of blood flow and/or tissue perfusion increases the chances of successful healing of both acute (e.g., surgical) and chronic wounds (Gurevich 2, ¶0004).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Gurevich and Gurevich 2 in combination do not explicitly disclose of the pixel data, calculate a first contribution value, of on pixel values, that are associated with the first color, of pixel values, that are associated with at least one other color and a second contribution value, of pixel values of pixel values of the second region that are associated with the at least one other color, by comparing the first contribution value to the second contribution value.
Steinbach is in the same field of fluorescent medical imaging. Further, Steinbach teaches of the pixel data (Steinbach Table 1 discloses all of the pixel data used to calculate the display pixel),
calculate a first contribution value (Steinbach ¶0129, ¶0155 disclose calculating a ratio encoded as a spectrum of colors from red to blue for all pixels)
of on pixel values (Steinbach ¶0051 discloses a ratio image to determine hue and brightness value of a pixel)
that are associated with the first color (Steinbach ¶0078, Fig 6 discloses the first color as green as evidenced by Fig 6, C)
of pixel values(Steinbach ¶0051 discloses a ratio image to determine hue and brightness value of a pixel)
that are associated with at least one other color (Steinbach ¶0070, ¶0155 discloses low ratio value being associated with blue and high ratio values being associated with red) and a second contribution value (Steinbach ¶0129, ¶0155 disclose calculating a ratio encoded as a spectrum of colors from red to blue for all pixels)
of pixel values (Steinbach ¶0051 discloses a ratio image to determine hue and brightness value of a pixel)
of pixel values (Steinbach ¶0051 discloses a ratio image to determine hue and brightness value of a pixel) of the second region that are associated with the at least one other color (Steinbach ¶0070, ¶0155 discloses low ratio value being associated with blue and high ratio values being associated with red)
by comparing the first contribution value to the second contribution value (Steinbach ¶0052 discloses the hue value being determined based on the ratio of two different images).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gurevich in view of Gurevich 2 by incorporating determining the intensity of the colors through their pixel value as taught by Steinbach, to make an invention that can differentiate between different structures in the body using their intensity pixel values to assist physicians during surgery; thus, one of ordinary skilled in the art would be motivated to combine the references since an object of the present invention is to continuously superimpose fluorescent images in real time precise spatial register to show the morphology of the tissue and the location of surgical instruments during surgery (Steinbach, ¶0004).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 33, Gurevich in view of Gurevich 2 in further view of Steinbach teaches the system of claim 32, wherein the visual enhancement value (Gurevich ¶0010 discloses calculating a similarity score) is included as part of a three-point or five-point visual enhancement scale (Steinbach Table 1, ¶0208 disclose an auto scale of the image or a preset scale being defined by the user) indicating a visibility improvement of the first region of the anatomy or pathology (Gurevich ¶0154 discloses enhancing the image based on the second imaging mode) of interest based on presence of the fluorescent imaging agent (Gurevich ¶0022 discloses the second imaging mode being one that include imaging agent). See Claim 32 for rationale, its parent claim.
Regarding Claim 34, Gurevich in view of Gurevich 2 in further view of Steinbach teaches the system of claim 32, wherein the instructions, when executed by the one or more processors (Gurevich ¶0043 discloses the processors storing programs to execute instructions), further cause the one or more processors to identify the first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) and the second region of the color image (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer¶0156 discloses sub-regions of frames) by:
comparing a pixel value for the first color of one or more first pixels (Steinbach Fig 1 and ¶0119 discloses the color value and map of multiple pixels) in the first region (Gurevich Fig 1, 102 discloses identifying a region of tissue of the subject) to a first pixel color value (Steinbach ¶0051 discloses a ratio image to determine hue and brightness value of a pixel) threshold (Gurevich ¶0152 discloses comparing the first imaging mode frame with a first and second predetermined threshold) and a pixel value of the first color of one or more second pixels (Steinbach Fig 1 and ¶0119 discloses the color value and map of multiple pixels) in the second region (Gurevich ¶0147 discloses how the fluorescence intensity drops indicating that the region that is being imaged is not need any longer¶0156 discloses sub-regions of frames) to the first pixel color value (Steinbach ¶0051 discloses a ratio image to determine hue and brightness value of a pixel) threshold(Gurevich ¶0152 discloses comparing the first imaging mode frame with a first and second predetermined threshold), and
determining that the pixel value for the first color of one or more first pixels (Steinbach Fig 1 and ¶0119 discloses the color value and map of multiple pixels and Table 1 discloses the algorithm on how it is determined) exceeds the first pixel color value threshold (Gurevich ¶0152 discloses comparing the first imaging mode frame with a first and second predetermined threshold) and that pixel value of the first color (Steinbach ¶0051 discloses a ratio image to determine hue and brightness value of a pixel) of the one or more second pixels is less than (Steinbach Fig 1 and ¶0119 discloses the color value and map of multiple pixels and how the values can be less than other pixels) the first pixel color value threshold (Gurevich ¶0152 discloses comparing the first imaging mode frame with a first and second predetermined threshold). See Claim 32 for rationale, its parent claim.
Regarding Claim 35, Gurevich in view of Gurevich 2 in further view of Steinbach teaches the system of claim 32, wherein the instructions, when executed by the one or more processors (Gurevich ¶0043 discloses the processors storing programs to execute instructions), further cause the one or more processors (Gurevich ¶0043 discloses the processors storing programs to execute instructions) to combine fluorescent pixel data (Gurevich ¶0137, ¶0143 disclose combining frames) of a fluorescent image of the anatomy or pathology of interest (Gurevich ¶0099 discloses the method in which the feature of interest is imaged) with white light pixel data of a white light image (Gurevich ¶0179, ¶0030, ¶0099 disclose using white light imaging) of the anatomy or pathology of interest to generate the pixel data (Steinbach Table 1 discloses all of the pixel data used to calculate the display pixel) of the color image (Gurevich ¶0143 disclose generating the color image). See Claim 32 for rationale, its parent claim.
Regarding Claim 36, Gurevich in view of Gurevich 2 in further view of Steinbach teaches the system of claim 32, wherein the measure of visual enhancement (Gurevich Fig 6, 602, ¶0053, ¶0132 discloses determining the signal intensity) comprises a measure of the perceived conspicuity (Gurevich Fig 2, 220 ¶0131 discloses generating a visible image frame of the desired region) of the anatomy or pathology of interest (Gurevich ¶0099 discloses the method in which the feature of interest is imaged). See Claim 32 for rationale, its parent claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL LYNN ROBERTS whose telephone number is (571)272-6413. The examiner can normally be reached Monday- Friday 7:30am- 5:00pm.
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/RACHEL L ROBERTS/Examiner, Art Unit 2674
/Ross Varndell/Primary Examiner, Art Unit 2674
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